,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342703,Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial.,"BACKGROUND


Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years.
METHODS


In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin.
RESULTS


Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively ( P =0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50-0.63) in RFU and 2.01 (1.93-2.05) in conventional follow-up per patient-year ( P <0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500-20 700 Yen) in RFU and 21 400 Yen (16 700-25 900 Yen) in conventional follow-up ( P <0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.
CONCLUSIONS


Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01523704.",2020,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","['In Japan, consecutive pacemaker patients committed to RM', '1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (CFU) patients reached either the primary endpoint or 24 months follow-up', 'Pacemaker Patients with Biennial In-clinic Evaluation', 'pacemaker patients for two years']","['exclusive remote follow-up (RFU', 'RFU']","['composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was non-inferiority with 5% margin', 'median (IQR) number of in-office follow-ups']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1274.0,0.189135,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Fujita Health University School of Medicine, Aichi (E.W.).'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital (F.Y.).'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Cardiology, Nagoya City University Hospital (T.G.), Aichi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiology, Ichinomiya Municipal Hospital (T. Asai), Aichi, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Handa City Hospital (T. Yamamoto), Aichi, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Hirooka', 'Affiliation': 'Department of Cardiology, National Hospital Organization Osaka National Hospital (K.H.), Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Kyorin University Hospital (T.S.), Tokyo, Japan.'}, {'ForeName': 'Atsunobu', 'Initials': 'A', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Ise Hospital, Mie (A.K.).'}, {'ForeName': 'Marehiko', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Chiba University Hospital (M.U.), Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital (T. Yamakawa), Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Japan (Y.U.).'}, {'ForeName': 'Katsuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Kochi Health Sciences Center, Japan (K.Y.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Cardiology, JA Toride Medical Ctr, Ibaraki, Japan (T.T.).'}, {'ForeName': 'Yoshinao', 'Initials': 'Y', 'LastName': 'Sugai', 'Affiliation': 'Department of Cardiology, Hiraka General Hospital, Akita, Japan (Y.S.).'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan (K.T.).'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiology, Fukuyama Cardiovascular Hospital, Hiroshima, Japan (S.H.).'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Arakawa', 'Affiliation': 'Department of Cardiology, Daido Hospital, Aichi, Japan (T. Arakawa).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schrader', 'Affiliation': 'Biotronik, Berlin, Germany (J.S.).'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cleveland Clinic, Heart & Vascular Institute, OH (N.V.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan (K.A.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007734']
1,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
2,32342840,Cost-Effectiveness of Mass Treatment with Azithromycin for Reducing Child Mortality in Malawi: Secondary Analysis from the MORDOR Trial.,"The recent Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin mass drug administration (MDA). Here, we investigate the financial costs and cost-effectiveness from the health provider perspective of azithromycin MDA at the MORDOR-Malawi study site. During MORDOR, a cluster-randomized trial involving biannual azithromycin MDA or placebo to children aged 1-59 months, fieldwork-related costs were collected, including personnel, transport, consumables, overheads, training, and supervision. Mortality rates in azithromycin- and placebo-treated clusters were calculated overall and for the five health zones of Mangochi district. These were used to estimate the number needed to treat to avert one death and the costs per death and disability-adjusted life year (DALY) averted. The cost per dose of MDA was $0.74 overall, varying between $0.63 and $0.94 in the five zones. Overall, the number needed to treat to avert one death was 1,213 children; the cost per death averted was $898.47, and the cost per DALY averted was $9.98. In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows: 3,070, $2,899.24, and $32.31 in Monkey Bay zone; 1,530, $1,214.42, and $13.49 in Chilipa zone; and 344, $217.98, and $2.42 in Namwera zone. This study is a preliminary cost-effectiveness analysis that indicates azithromycin MDA for reducing child mortality has the potential to be highly cost-effective in some settings in Malawi, but the reasons for geographical variation in effectiveness require further investigation.",2020,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:",['Malawi'],"['biannual azithromycin MDA or placebo', 'azithromycin- and placebo', 'Azithromycin', 'azithromycin MDA', 'azithromycin']","['cost per death averted', 'child mortality', 'cost per dose of MDA', 'Child Mortality', 'financial costs and cost-effectiveness', 'mortality', 'Mortality rates']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0794041,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0622']
3,32342841,Effects of Biannual Azithromycin Mass Drug Administration on Malaria in Malawian Children: A Cluster-Randomized Trial.,"Reductions in malaria morbidity have been reported following azithromycin mass drug administration (MDA) for trachoma. The recent Macrolides Oraux pour Reduire les Deces avec un Oeil sur la Resistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin MDA. Here, we investigate the effects of azithromycin MDA on malaria at the MORDOR-Malawi study site. A cluster-randomized double-blind placebo-controlled trial, with 15 clusters per arm, was conducted. House-to-house census was updated biannually, and azithromycin or placebo syrup was distributed to children aged 1-59 months for a total of four biannual distributions. At baseline, 12-month, and 24-month follow-up visits, a random sample of 1,200 children was assessed for malaria with thick and thin blood smears and hemoglobin measurement. In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities; 95% CI: -2.8 to 1.5), or anemia (1.7% lower in azithromycin-treated communities; 95% CI: -8.1 to 4.6) between placebo and azithromycin communities. Further interrogation of the data at the individual level, both per-protocol (including only those who received treatment 6 months previously) and by intention-to-treat, did not identify differences in parasitemia between treatment arms. In contrast to several previous reports, this study did not show an effect of azithromycin MDA on malaria parasitemia at the community or individual levels.",2020,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities",['Malaria in Malawian Children'],"['azithromycin or placebo syrup', 'azithromycin MDA', 'azithromycin', 'Biannual Azithromycin Mass Drug Administration', 'azithromycin-treated communities', 'placebo']","['child mortality', 'malaria parasitemia', 'anemia', 'prevalence of parasitemia', 'gametocytemia', 'malaria morbidity', 'malaria with thick and thin blood smears and hemoglobin measurement']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",1200.0,0.469202,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lyson', 'Initials': 'L', 'LastName': 'Samikwa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Feston', 'Initials': 'F', 'LastName': 'Sikina', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Burr', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0619']
4,32343000,Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome.,"BACKGROUND


Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis.
AIM


To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS.
METHODS


Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score. The secondary outcomes were levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight.
RESULTS


The primary endpoint was not achieved in either group. However, there was a transient reduction in the mean IBS Symptom Severity Score in the FMT group at 12 weeks after treatment as compared to baseline (P = 0.01). The groups did not differ in the number of patients achieving clinical response at 12 weeks. In the FMT-treated patients, microbial composition had changed to resemble that of the donor and the stool water content decreased significantly compared to baseline. The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
CONCLUSIONS


FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.",2020,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","['irritable bowel syndrome', 'Forty-nine', 'IBS patients', 'Irritable bowel syndrome (IBS']","['FMT', 'faecal microbiota transplantation versus autologous placebo', 'faecal microbiota transplantation (FMT', 'autologous or allogenic FMT via colonoscopy']","['sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score', 'microbial composition', 'number of patients achieving clinical response', 'IBS symptoms', 'stool water content', 'levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight', 'depression score', 'mean IBS Symptom Severity Score']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",49.0,0.164282,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","[{'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Jalanka', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hartikainen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Mattila', 'Affiliation': 'Department of Infectious Diseases, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Hillilä', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Punkkinen', 'Affiliation': 'Department of Gastroenterology, Porvoo Hospital, Porvoo, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Koskenpato', 'Affiliation': 'Department of Gastroenterology, Aava Medical Centre, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Tillonen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Satokari', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Arkkila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15740']
5,32275480,A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality (CAMS) Versus Treatment as Usual (TAU) for Suicidal College Students.,"This randomized controlled trial compared the Collaborative Assessment and Management of Suicidality (CAMS) and Treatment as Usual (TAU) for suicidal college students within a feasibility trial. Sixty-two suicidal college students were randomized to CAMS ( n  = 33) or TAU ( n  = 29). We hypothesized that those receiving CAMS would show more improvement in suicide-related measures, and effects would be moderated by borderline personality disorder (BPD), prior suicide attempts, and age. Both treatment groups showed improvements in all outcome variables; CAMS had a significantly higher impact on depression and suicidal ideation when measured weekly during care and was more likely than TAU to decrease hopelessness among students with fewer BPD features, no suicide attempt history, and older age. Conversely, TAU did better for students with BPD features and history of multiple suicide attempts.",2020,"Both treatment groups showed improvements in all outcome variables; CAMS had a significantly higher impact on depression and suicidal ideation when measured weekly during care and was more likely than TAU to decrease hopelessness among students with fewer BPD features, no suicide attempt history, and older age.","['suicidal college students', 'Sixty-two suicidal college students', 'Suicidal College Students']","['TAU', 'CAMS', 'Usual (TAU', 'Collaborative Assessment and Management of Suicidality (CAMS) and Treatment as Usual (TAU', 'Collaborative Assessment and Management of Suicidality (CAMS']",['depression and suicidal ideation'],"[{'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",62.0,0.158735,"Both treatment groups showed improvements in all outcome variables; CAMS had a significantly higher impact on depression and suicidal ideation when measured weekly during care and was more likely than TAU to decrease hopelessness among students with fewer BPD features, no suicide attempt history, and older age.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Pistorello', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jobes', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': ''}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': ''}, {'ForeName': 'Nadia Samad', 'Initials': 'NS', 'LastName': 'Locey', 'Affiliation': ''}, {'ForeName': 'Josephine S', 'Initials': 'JS', 'LastName': 'Au', 'Affiliation': ''}, {'ForeName': 'Samantha K', 'Initials': 'SK', 'LastName': 'Noose', 'Affiliation': ''}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Walloch', 'Affiliation': ''}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'Dickens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Chatham', 'Affiliation': ''}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Jeffcoat', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1749742']
6,32339648,Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.,"BACKGROUND


The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.
PATIENTS AND METHODS


Treatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1-positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population.
RESULTS


Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490-0.777]}; one-sided P < 0.0001; median 13.8 (95% CI 10.1-20.7) versus 7.0 months (95% CI 5.7-9.6); overall population: HR 0.69 (95% CI 0.574-0.825); one-sided P < 0.0001; median 13.3 (95% CI 11.1-15.3) versus 8.0 months (95% CI 6.7-9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596-1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616-1.027); one-sided P = 0.0392].
CONCLUSION


Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature.
CLINICAL TRIAL NUMBER


NCT02684006.",2020,OS data were immature (PD-L1+ population: HR 0.828,"['886 patients', 'advanced renal cell carcinoma (aRCC', 'patients with advanced renal cell carcinoma', 'Treatment-naïve patients with aRCC']","['axitinib (5 mg) orally twice daily or sunitinib', 'avelumab plus axitinib versus sunitinib', 'avelumab', 'avelumab plus axitinib']","['progression-free survival (PFS', 'PFS', 'OS and PFS in the overall population', 'PFS and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.268726,OS data were immature (PD-L1+ population: HR 0.828,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, USA. Electronic address: toni_choueiri@dcfi.harvard.edu.""}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Venugopal', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'British Columbia Cancer Agency, Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gravis-Mescam', 'Affiliation': 'Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'M-O', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Jena University Hospital, Department of Urology, Jena, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Macquarie University, Sydney, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Clinical Division of Oncology, Department of Medicine I Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope National Medical Center, Duarte, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Pfizer, Cambridge, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Pfizer, Groton, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cislo', 'Affiliation': 'Pfizer, New York, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Pfizer, Cambridge, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Pfizer, Groton, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.010']
7,32340075,Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,"OBJECTIVE


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


Parallel-group randomised controlled trial.
SETTING


A UK endometriosis centre.
POPULATION


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


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


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


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


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


Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis.",2020,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","['laparoscopic treatment of mild-to-moderate endometriosis', 'A UK endometriosis centre', '192 women were randomized', 'mild-to-moderate endometriosis', 'Non-pregnant women aged 16-50 with a clinical diagnosis of mild-to-moderate endometriosis']","['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy', 'electrodiathermy', 'laparoscopic treatment with electrodiathermy or helium thermal coagulator']","['cyclical pain and dyspareunia', 'operative blood loss; surgical complications', 'Cyclical pain and dyspareunia (rated on 100mm visual analogue scales), and quality of life', 'dyspareunia', 'operative blood loss', 'VAS scores for cyclical pain']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",192.0,0.391918,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'El-Gizawy', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jerreat', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritchie', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16279']
8,32340871,Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study.,"BACKGROUND


Aspirin (ASA) anti-platelet therapy is mandated with left ventricular assist devices (LVADs) to prevent hemocompatibility-related adverse events (HRAEs). However, the optimal dose of ASA with HeartMate 3 (HM3) LVAD is unknown.
METHODS


In an exploratory analysis of HM3-supported patients in the MOMENTUM 3 study (NCT02224755), 2 groups were analyzed: usual-dose (325 mg) and low-dose (81 mg) ASA with anti-coagulation targeted to an international normalized ratio of 2.0 to 3.0. Exclusion criteria included patients not receiving either ASA 81 mg or 325 mg, those with HRAEs ≤7 days after device implantation, and those receiving >1 anti-platelet agent. The primary end-point was survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events) at 2 years.
RESULTS


Overall, 321 HM3 patients (usual-dose: n = 141, low-dose: n = 180) were included in this analysis. Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA. At 2 years, a similar proportion of patients in the usual- and low-dose groups (43.4% vs 45.3%, p = 0.94) met the primary end-point. There were no differences in survival free from hemorrhagic (usual-dose: 54.4% vs low-dose: 51.7%, p = 0.42) or thrombotic (usual-dose: 76.8% vs low-dose: 75.7%, p = 0.92) events.
CONCLUSIONS


Usual- and low-dose ASA revealed similar rates of bleeding and thrombotic events in HM3 LVAD-supported patients within the MOMENTUM 3 trial. Whether ASA therapy provides any meaningful therapeutic effect in patients treated by the HM3 LVAD remains to be determined.",2020,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","['321 HM3 patients (usual-dose: n\u202f=\u202f141, low-dose: n\u202f=\u202f180']","['Aspirin (ASA) anti-platelet therapy', 'ASA', 'aspirin']","['thrombotic', 'survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events', 'rates of bleeding and thrombotic events', 'survival free from hemorrhagic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}]",180.0,0.064419,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Paolo C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cleveland', 'Affiliation': 'Department of Surgery, University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Samer S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Department of Medicine, Medstar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Nahush A', 'Initials': 'NA', 'LastName': 'Mokadam', 'Affiliation': 'Department of Surgery, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgery, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Ulrich P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York. Electronic address: ujorde@montefiore.org.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.001']
9,32342016,Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study.,"​Background


Cognitive-behavioural therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in postinfectious chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might be feasible. We studied the feasibility of a combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.
​Methods


Adolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present feasibility study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months.
​Results


A total of 43 individuals with postinfectious CF were included (21 intervention group, 22 control group). Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months' follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, number of steps/day tended to decrease (difference=-1158, 95% CI -2642 to 325), whereas postexertional malaise tended to improve (difference=-0.4, 95% CI -0.9 to 0.1) in the intervention group at 3 months. At 15 months' follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).
​Conclusion


An intervention study of combined CBT and music therapy in postinfectious CF is feasible, and appears acceptable to the participants. The tendencies towards positive effects on patients' symptoms and recovery might justify a full-scale clinical trial.
​Trial registration number


NCT02499302.",2020,"At 15 months' follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).
","['\u200bMethods\n\n\nAdolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6\u2009months after an acute EBV infection were eligible for the present feasibility study', 'chronic fatigue following Epstein-Barr virus infection in adolescents', '43 individuals with postinfectious CF', 'chronic fatigue syndrome', 'adolescents']","['combined CBT and music therapy', 'CBT and music therapy programme', '\u200b\n\n\nCognitive-behavioural therapy (CBT', 'CBT', 'Cognitive-behavioural therapy combined with music therapy', 'combined CBT and music therapy intervention']","['postexertional malaise', 'recovery rate', 'physical activity (steps/day), symptom scores, recovery rate and possible harmful effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149678', 'cui_str': 'Epstein-Barr virus disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",43.0,0.148649,"At 15 months' follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).
","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Pediatrics, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Tarjei Tørre', 'Initials': 'TT', 'LastName': 'Asprusten', 'Affiliation': 'Pediatrics, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Drammen Hospital, Drammen, Norway.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mangersnes', 'Affiliation': 'Pediatrics, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gro', 'Initials': 'G', 'LastName': 'Trondalen', 'Affiliation': 'Center for Music and Health, Norwegian College of Music, Oslo, Norway.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'van Roy', 'Affiliation': 'Pediatrics, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Vegard Bruun', 'Initials': 'VB', 'LastName': 'Wyller', 'Affiliation': 'Pediatrics, Akershus University Hospital, Lørenskog, Norway.'}]",BMJ paediatrics open,['10.1136/bmjpo-2019-000620']
10,32347005,Combined Application of Dexamethasone and Tranexamic Acid to Reduce the Postoperative Inflammatory Response and Improve Functional Outcomes in Total Hip Arthroplasty.,"OBJECTIVE


To evaluate the efficacy and safety of combined use of tranexamic acid (TXA) and dexamethasone (DEX) for anti-inflammatory and clinical outcomes after total hip arthroplasty (THA).
METHODS


A total of 100 patients were included in this randomized, controlled study. Patients in the TXA + DEX group were administered TXA at a dose of 15 mg/kg, which was repeated 3 h after THA, and received 20 mg DEX. In contrast, patients in the TXA group were administered TXA at a dose of 15 mg/kg, which was repeated at 3 h postoperatively. C-reactive protein (CRP), interleukin-6 (IL-6) and pain levels, incidence of postoperative nausea and vomiting (PONV), total blood loss and transfusion rates, postoperative fatigue, range of motion (ROM), length of hospital stay (LOS), analgesic rescue and antiemetic rescue consumption, and complications were compared in both groups.
RESULTS


The CRP and IL-6 levels were lower in the TXA + DEX group than in the TXA group (all P < 0.001) at 24 h, 48 h, and 72 h postoperatively. Patients in the TXA + DEX group had lower pain scores at rest and walking at 24 h postoperatively (all P < 0.001). In the TXA + DEX group, the incidence of PONV was lower (P = 0.005), postoperative fatigue (P < 0.001) was reduced, and analgesia and antiemetic rescue consumption were also reduced. The total blood loss, transfusion rate, LOS and hip ROM were similar in the two groups. There was no thrombosis, infection, or gastrointestinal bleeding in either group.
CONCLUSION


Compared to TXA alone, the combination of TXA + DEX can reduce postoperative inflammatory response, relieve pain, and reduce PONV and fatigue, without increasing the risk of complications. Therefore, the present study suggested that the combination of TXA + DEX is an effective and safe accelerated rehabilitation strategy for patients receiving primary unilateral THA.",2020,Patients in the TXA + DEX group had lower pain scores at rest and walking at 24 h postoperatively (all P < 0.001).,"['Total Hip Arthroplasty', 'total hip arthroplasty (THA', 'A total of 100 patients', 'patients receiving primary unilateral THA']","['20\u2009mg DEX', 'tranexamic acid (TXA) and dexamethasone (DEX', 'TXA', 'Dexamethasone and Tranexamic Acid', 'TXA\u2009+\u2009DEX']","['pain scores', 'postoperative inflammatory response, relieve pain, and reduce PONV and fatigue', 'Postoperative Inflammatory Response', 'postoperative fatigue', 'total blood loss, transfusion rate, LOS and hip ROM', 'efficacy and safety', 'incidence of PONV', 'analgesia and antiemetic rescue consumption', 'C-reactive protein (CRP), interleukin-6 (IL-6) and pain levels, incidence of postoperative nausea and vomiting (PONV), total blood loss and transfusion rates, postoperative fatigue, range of motion (ROM), length of hospital stay (LOS), analgesic rescue and antiemetic rescue consumption, and complications', 'CRP and IL-6 levels', 'thrombosis, infection, or gastrointestinal bleeding']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",100.0,0.0883103,Patients in the TXA + DEX group had lower pain scores at rest and walking at 24 h postoperatively (all P < 0.001).,"[{'ForeName': 'Yu-Zhang', 'Initials': 'YZ', 'LastName': 'An', 'Affiliation': 'Department of Orthopaedic Surgery, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 401120, China.'}, {'ForeName': 'Ming-Deng', 'Initials': 'MD', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedic Surgery, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 401120, China.'}, {'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'An', 'Affiliation': 'Department of Cardiology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 401120, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Surgical Inpatient, Cai Jia Hospital, Chongqing, 401120, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopaedic Surgery, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 401120, China.'}, {'ForeName': 'Dian-Ming', 'Initials': 'DM', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, 401120, China.'}]",Orthopaedic surgery,['10.1111/os.12664']
11,32346686,"Clinical Research of the Application of Bone Turnover Markers in Monitoring the Short-Term Therapeutic Efficacy of Vitamin D in Postmenopausal Osteoporotic women in Harbin, China.","BACKGROUND


The incidence of osteoporosis (OP) is increasing year by year. researches have shown that there was an intense link between the vitamin D (VitD) status and the efficacy of zoledronate (ZOL) in patients with osteoporosis. Since VitD is related to the geogen, its promotion effect on zoledronate has regional specificity.
AIM


Combining dual-energy X-ray and bone turnover markers (BTM) to explore the VitD level in postmenopausal osteoporosis patients in Harbin and monitor its effect on the anti-osteoporosis effect of ZOL.
METHODS


A total of 120 patients with postmenopausal osteoporosis (PMO) were enrolled .These patients were divided into two groups with 25(OH)D levels = 10ng/ml as a critical point, and each group was randomly divided into experimental groups and control groups). All of the patients were conducted 5 mg ZOL. Then the experimental group was given calcitriol and calcium carbonate, and the control group was only given calcium carbonate. BTM were measured at baseline, 24h, 3 months and 6 months. We also measured bone mineral density (BMD) of bilateral hips (TH BMD) and lumbar spine (LS BMD) at baseline and 6 months.
RESULTS


The VitD deficiency rates of the patients enrolled were 84.1%. There was an inverse relationship between the baseline level of VitD and the serum levels of P1NP / β-CTX, (r=-0.452,p=0.00; r=-0.225, p=0.01). Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05). The mean decreasing rates of P1NP and β-CTX in the both experimental groups were significantly higher than that of the corresponding control groups at the same time point (P<0.05), after 6 months of medication. Both TH BMD and LS BMD at 6 months increased significantly. The increase rate of LS BMD in the high VitD experimental group was significantly higher than the other three groups (P<0.05), the increase rates of TH BMD in the low VitD control group were significantly lower than the other three groups (P<0.05).
CONCLUSIONS


The levels of serum VitD in the patients enrolled in this study were generally low. VitD could increase the therapeutic effect of ZOL on osteoporosis.",2020,"Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05).","['patients with osteoporosis', 'Postmenopausal Osteoporotic women in Harbin, China', '120 patients with postmenopausal osteoporosis (PMO) were enrolled .These', 'postmenopausal osteoporosis patients in Harbin']","['Vitamin D', 'calcitriol and calcium carbonate', 'ZOL', 'zoledronate (ZOL', 'calcium carbonate', 'dual-energy X-ray and bone turnover markers (BTM']","['rate of LS BMD', 'BTM', 'level of serum P1NP,β-CTX', 'baseline level of VitD and the serum levels of P1NP / β-CTX', 'rates of TH BMD', 'levels of serum VitD', 'bone mineral density (BMD) of bilateral hips (TH BMD) and lumbar spine (LS BMD', 'TH BMD and LS BMD', 'mean decreasing rates of P1NP and β-CTX', 'VitD deficiency rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]",120.0,0.0130508,"Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yansong Wang, Department of Spine Surgery, the First Affiliated Hospital of Harbin Medical University, Harbin, China, wangyans1975@163.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1362-z']
12,32347899,Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial.,"Importance


Evidence-based treatments from randomized clinical trials for pedophilic disorder are lacking.
Objective


To determine whether a gonadotropin-releasing hormone antagonist reduces dynamic risk factors for committing child sexual abuse.
Design, Setting, and Participants


This academically initiated, double-blind, placebo-controlled, parallel-group, phase 2 randomized clinical trial was conducted at the ANOVA center in Stockholm, Sweden, from March 1, 2016, to April 30, 2019. Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited. Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention. The primary end point was assessed by intent-to-treat analysis.
Interventions


Randomization to receive either 2 subcutaneous injections of 120 mg of degarelix acetate or equal volume of placebo.
Main Outcomes and Measures


The primary end point was the mean change between baseline and 2 weeks in the composite risk score of 5 domains of child sexual abuse ranging from 0 to 15 points; each domain could be rated from 0 to 3 points. Secondary end points included efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events.
Results


A total of 52 male participants (mean [SD] age, 36 [12] years) were randomized to receive either degarelix (n = 25; with 1 withdrawal) or placebo (n = 26). At 2 weeks, the composite risk score decreased from 7.4 to 4.4 for participants in the degarelix group and from 7.8 to 6.6 for the placebo group, a mean between-group difference of -1.8 (95% CI, -3.2 to -0.5; P = .01). A decrease was seen in the composite score at 10 weeks (-2.2 [95% CI, -3.6 to -0.7]) as well as in the domains of pedophilic disorder (2 weeks: -0.7 [95% CI, -1.4 to 0.0]; 10 weeks: -1.1 [95% CI, -1.8 to -0.4]) and sexual preoccupation (2 weeks: -0.7 [95% CI, -1.2 to -0.3]; 10 weeks: -0.8 [95% CI, -1.3 to -0.3]) in the degarelix group compared with the placebo group. No difference was seen for the domains of self-rated risk (2 weeks: -0.4 [95% CI, -0.9 to 0.1]; 10 weeks: -0.5 [95% CI, -1 to 0.0]), low empathy (2 weeks: 0.2 [95% CI, -0.3 to 0.6]; 10 weeks: 0.2 [95% CI, -0.2 to 0.6]), and impaired self-regulation (2 weeks: -0.0 [95% CI, -0.7 to 0.6]; 10 weeks: 0.1 [95% CI, -0.5 to 0.8]), or quality of life (EuroQol 5 Dimensions questionnaire index score, 2 weeks: 0.06 [95% CI, -0.00 to 0.12], and 10 weeks: 0.04; 95% CI, -0.02 to 0.10; EuroQol visual analog scale, 2 weeks: 0.6 [95% CI, -9.7 to 10.9], and 10 weeks: 4.2 [95% CI, -6.0 to 14.4]). Two hospitalizations occurred from increased suicidal ideation, and more injection site reactions (degarelix: 22 of 25 [88%]; placebo: 1 of 26 [4%]) and hepatobiliary enzyme level elevations were reported by participants who received degarelix (degarelix: 11 of 25 [44%]; placebo: 2 of 26 [8%]). Among the 26 participants randomized to receive degarelix, 20 (77%) experienced positive effects (eg, improved attitude or behavior) on sexuality and 23 (89%) reported adverse effects on the body.
Conclusion and Relevance


This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option. Further studies are warranted into the effects and long-term adverse effects of hormone deficiency.
Trial Registration


EU Clinical Trials Register Identifier: 2014-000647-32.",2020,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","['committing child sexual abuse', 'Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention', 'Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited', 'Men With Pedophilic Disorder', '52 male participants (mean [SD] age, 36 [12] years']","['Gonadotropin-Releasing Hormone Antagonist', 'degarelix acetate or equal volume of placebo', 'gonadotropin-releasing hormone antagonist', 'degarelix (degarelix', 'degarelix', 'placebo']","['sexual preoccupation', 'intent-to-treat analysis', 'low empathy', 'efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events', 'composite risk score of 5 domains of child sexual abuse', 'Risk of Committing Child Sexual Abuse', 'composite risk score', 'suicidal ideation', 'hepatobiliary enzyme level elevations', 'composite score', 'impaired self-regulation', 'positive effects (eg, improved attitude or behavior) on sexuality', 'adverse effects', 'EuroQol visual analog scale', 'quality of life (EuroQol 5 Dimensions questionnaire index score', 'injection site reactions']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C2718533', 'cui_str': 'degarelix acetate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}]","[{'cui': 'C0423988', 'cui_str': 'Sexual preoccupation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",52.0,0.615958,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","[{'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Landgren', 'Affiliation': 'Institute of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Kinda', 'Initials': 'K', 'LastName': 'Malki', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Rahm', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0440']
13,32354228,Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial.,"BACKGROUND


Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisions regarding duration of DAPT in patients undergoing percutaneous coronary intervention, use of the PRECISE-DAPT score to guide duration of DAPT has not been properly validated by randomized trials focused on the population with acute coronary syndrome. This study aimed to evaluate the usefulness of the PRECISE-DAPT score for predicting future bleeding and ischemic events and to compare clinical outcomes of short-term and long-term DAPT duration according to the PRECISE-DAPT score in patients with acute coronary syndrome.
METHODS


This was a substudy of the SMART-DATE trial (6- Versus 12-Month or Longer Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), in which patients with acute coronary syndrome undergoing percutaneous coronary intervention were randomly assigned to either 6- (n=1357) or 12-month or longer DAPT (n=1355). Major bleeding (Bleeding Academic Research Consortium type 3-5) and ischemic (myocardial infarction, stent thrombosis, or ischemic stroke) events at 18 months after the index procedure were compared between the 6- and 12-month or longer DAPT groups, according to PRECISE-DAPT score.
RESULTS


The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655-0.854];  P <0.001). In patients with nonhigh PRECISE-DAPT score (<25, n=1967 [72.5%]), 6-month DAPT was associated with higher ischemic risk (2.7% versus 1.3%; HR, 2.01 [95% CI, 1.03-3.91];  P =0.040; absolute risk difference, +1.3%;  P =0.035) with similar bleeding risk (0.4% versus 0.3%; HR, 2.00 [95% CI, 0.37-10.94];  P =0.422; absolute risk difference, +0.2%;  P =0.498), compared with 12-month or longer DAPT. Among patients with high PRECISE-DAPT score (≥25, n=745 [27.5%]), 6-month DAPT presented a similar ischemic risk (4.8% versus 3.4%; HR, 1.43 [95% CI, 0.68-2.98],  P =0.348; absolute risk difference, +1.5%;  P =0.327) but significantly reduced major bleeding risk (0.6% versus 2.3%; HR, 0.25 [95% CI, 0.05-1.17];  P =0.079; absolute risk difference, -1.7%;  P =0.045).
CONCLUSIONS


Consistent with current guidelines, determination of the duration of DAPT according to PRECISE-DAPT score could improve the clinical outcomes in patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01701453.",2020,"The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655-0.854];  P <0.001).","['patients with acute coronary syndrome', 'patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents', 'Patients With Acute Coronary Syndrome', 'Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention', 'patients with acute coronary syndrome undergoing percutaneous coronary intervention', 'patients undergoing percutaneous coronary intervention', 'Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy']","['6- Versus 12-Month or Longer Dual Antiplatelet Therapy', 'Percutaneous Coronary Intervention', 'DAPT Score']","['ischemic risk', 'bleeding risk', 'major bleeding risk', 'bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0741222,"The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655-0.854];  P <0.001).","[{'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Taek Kyu', 'Initials': 'TK', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Seung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Ju-Hyeon', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Korea (J.-H.O.).'}, {'ForeName': 'Deok-Kyu', 'Initials': 'DK', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Myongji Hospital, Goyang, Korea (D.-K.C.).'}, {'ForeName': 'Jin Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Korea (J.B.L.).'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea (J.-H.D.).'}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Boramae Medical Center, Korea (S.-H.K.).'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea (J.-O.J.).'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Konyang University Hospital, Daejon, Korea (J.-H.B.).'}, {'ForeName': 'Byung-Ok', 'Initials': 'BO', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea (B.-O.K.).'}, {'ForeName': 'Jang Hyun', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, St. Carollo General Hospital, Suncheon, Korea (J.H.C.).'}, {'ForeName': 'Il-Woo', 'Initials': 'IW', 'LastName': 'Suh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, SAM Medical Center, Anyang, Korea (I.-W.S.).'}, {'ForeName': 'Doo-Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea (D.-i.K.).'}, {'ForeName': 'Hoon-Ki', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul Veterans Hospital, Korea (H.-K.P.).'}, {'ForeName': 'Jong-Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea (J.-S.P.).'}, {'ForeName': 'Woong Gil', 'Initials': 'WG', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungju Konkuk University Medical Center, Korea (W.G.C.).'}, {'ForeName': 'Wang Soo', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea (W.S.L.).'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}, {'ForeName': 'Joo-Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008530']
14,32343890,Olaparib for Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.
METHODS


We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.
RESULTS


In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.
CONCLUSIONS


In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"['Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone', 'patients with prostate and other cancers', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving', 'Metastatic Castration-Resistant Prostate Cancer']","['PARP inhibitor olaparib', 'enzalutamide or abiraterone', ""olaparib or the physician's choice of enzalutamide or abiraterone (control"", 'Olaparib']","['objective response rate and the time to pain progression', 'Anemia and nausea', 'median overall survival', 'imaging-based progression-free survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",245.0,0.264475,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1911440']
15,32349742,The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial.,"BACKGROUND


One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP-DM).
METHOD


This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers.
RESULT


104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and IL-6 (OR 2.56 [1.00-6.53]) in favor of the active group. There was also a significant (p = 0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0 months, to 140 (SD: 15) mmHg after 12 months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group.
CONCLUSIONS


AGE inhibits CAC progression, lowers IL-6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE.
TRIAL REGISTRATION


Clinical trials NCT03860350, retrospectively registered (1/32019).",2020,"There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and","['university hospital in Europe', '104 patients were randomized and 46 in the active group and 47 in the', 'Patients with a Framingham risk score\u2009≥\u200910 after CT scan (n\u2009=\u2009104']","['placebo or AGE', 'aged garlic extract', 'aged garlic extract (AGE', 'placebo']","['blood pressure', 'blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers', 'CAC progression', 'blood glucose', 'accuracy score for CAC progression', 'CAC progression, lowers IL-6, glucose levels and blood pressure', 'IL-6', 'systolic blood pressure', 'changes in CAC score']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",104.0,0.616204,"There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and","[{'ForeName': 'Martiné', 'Initials': 'M', 'LastName': 'Wlosinska', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hlebowicz', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hauggaard', 'Affiliation': 'Department of Radiology, Cardiac Imaging, Skåne Hospital Northwest, Helsingborg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kjellin', 'Affiliation': 'Department of Radiology, Cardiac Imaging, Skåne Hospital Northwest, Helsingborg, Sweden.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Fakhro', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lindstedt', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden. sandra.lindstedt.ingemansson@gmail.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02932-5']
16,32349752,The use of a task through virtual reality in cerebral palsy using two different interaction devices (concrete and abstract) - a cross-sectional randomized study.,"BACKGROUND


Cerebral Palsy (CP) is characterised by variable difficulties in muscular action, resulting in inability of the individual to perform functional movement. An option to provide functionality to the individual with CP is the use of computer innovation. The aim of this paper was to verify if there was any performance improvement in a task performed in a virtual environment and if there was transfer to the task performed in the real environment and vice versa in this population.
METHODS


A computer program was developed comprising a motor task, but with two possibilities of user interaction: a) concrete interface (with physical contact): in which the individual touches the computer screen to finish the task and b) abstract interface (no physical contact): in which the individual performs a hand movement in front of the Kinect device. Participants were split into two groups. The experimental group consisted of 28 individuals with CP within the ages of 6 and 15 years old. The control group included 28 typically developing individuals mirroring the age and sex of the experimental group.
RESULTS


Individuals from both groups were able to improve task performance and retain acquired information. The CP group presented worse performance than the control group in all phases of the study. Further findings showed that the CP group presented better performance in the abstract interface than in the concrete interface, whereas, in the control group, the opposite occurred: their best performance was in the concrete.
CONCLUSIONS


Motor tasks performed by individuals with CP through an interface with a more virtual environment feature (abstract interface: Kinect) provided better performance when compared to an interface with a more real characteristic (concrete interface: Touchscreen).
TRIAL REGISTRATION


ClinicalTrials.gov Identifier - NCT03352440; Date of registration - November 17, 2017.",2020,The CP group presented worse performance than the control group in all phases of the study.,"['28 individuals with CP within the ages of 6 and 15\u2009years old', '28 typically developing individuals mirroring the age and sex of the experimental group']",['CP'],['task performance and retain acquired information'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]",28.0,0.0258486,The CP group presented worse performance than the control group in all phases of the study.,"[{'ForeName': 'Andréa Fernanda', 'Initials': 'AF', 'LastName': 'Leal', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}, {'ForeName': 'Talita Dias', 'Initials': 'TD', 'LastName': 'da Silva', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil. ft.talitadias@gmail.com.'}, {'ForeName': 'Priscila Bianchi', 'Initials': 'PB', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Bahadori', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth University, Executive Business Centre, Holdenhurst Road, Bournemouth, BH8 8EB, UK.'}, {'ForeName': 'Luciano Vieira', 'Initials': 'LV', 'LastName': 'de Araújo', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Murillo Vinicius Brandão', 'Initials': 'MVB', 'LastName': 'da Costa', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Íbis Ariana Peña', 'Initials': 'ÍAP', 'LastName': 'de Moraes', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo Henrique', 'Initials': 'RH', 'LastName': 'Marques', 'Affiliation': 'Programa de Pós-Graduação em Bioengenharia, Universidade Brasil, São Paulo, SP, Brazil.'}, {'ForeName': 'Tania Brusque', 'Initials': 'TB', 'LastName': 'Crocetta', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'de Abreu', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}, {'ForeName': 'Carlos Bandeira de Mello', 'Initials': 'CBM', 'LastName': 'Monteiro', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00689-z']
17,32343855,Utility of the QTA30 in a school medical checkup for adolescent students.,"BACKGROUND


In adolescence, physical symptoms may develop due to psychosocial problems, but such problems are not fully evaluated in school medical checkups. The aim of the study was to compare the characteristics of students with high and low scores on the Questionnaire for Triage and Assessment with 30 items (QTA30) in a school health checkup.
METHODS


The QTA30 (a self-completed questionnaire) was used in checkups for 3,414 students from the 5th grade of primary schools to the 3rd grade of junior high schools in south Wakayama Prefecture. The students were divided into groups with high (QTA30 ≥ 37) and low (QTA30 < 37) risk for psychosomatic disorder. Eleven items, including gender, grade, lifestyle habits, and life events, were compared between these groups, and in subgroups with and without recent absence from school.
RESULTS


The QTA30 response rate was 87.9%. The high-risk group had significantly more 3rd grade students (P < 0.001), females (P < 0.001), problems with teachers or friends (P < 0.001), and experience of bullying (P < 0.001), in addition to game playing for ≥2 h (P < 0.001), late bedtime (P < 0.001), and many absences (P < 0.001). Students in the high-risk group with no absences for 1 month regardless of age still had a late bedtime and problems with friends, and 76.4% of the high-risk students had not visited a medical institution.
CONCLUSIONS


Use of the QTA30 facilitated detection of psychosomatic stress in school medical checkups, with latent risks of truancy detectable at an early phase. The QTA30 may thus be useful in early intervention for psychosomatic stress of adolescents.",2020,"The high risk group had significantly more 3rd grade students (p<0.001), females (p<0.001), problems with teachers or friends (p<0.001), and experience of bullying (p<0.001), in addition to game playing for ≥2 hours (p<0.001), late bedtime (p<0.001), and many absences (p<0.001).","['3,414 students from 5th grade of primary schools to 3rd grade of junior high schools in south Wakayama Prefecture', 'Students in the high risk group with no absences for one month regardless of age still had a late bedtime and problems with friends, and 76.4% of the high-risk students had not visited a medical institution', 'students with high and low scores on the Questionnaire for Triage and Assessment with 30 items (QTA30) in a school health checkup', 'adolescent students']",['QTA30'],['QTA30 response rate'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",3414.0,0.0273128,"The high risk group had significantly more 3rd grade students (p<0.001), females (p<0.001), problems with teachers or friends (p<0.001), and experience of bullying (p<0.001), in addition to game playing for ≥2 hours (p<0.001), late bedtime (p<0.001), and many absences (p<0.001).","[{'ForeName': 'Chizu', 'Initials': 'C', 'LastName': 'Habukawa', 'Affiliation': 'Department of Pediatric Allergy, Minami Wakayama Medical Center, Tanabe, Wakayama-ken.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nagamitsu', 'Affiliation': 'Department of Pediatrics, Kurume University, Kurume, Fukuoka-ken.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Koyanagi', 'Affiliation': 'Nagasaki Prefectural Center of Medicine and Welfare for Children, Isahaya, Nagasaki-ken.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Nishikii', 'Affiliation': 'Department of Pediatrics, Nagasaki Hospital, Isahaya, Nagasaki-ken.'}, {'ForeName': 'Yoshitoki', 'Initials': 'Y', 'LastName': 'Yanagimoto', 'Affiliation': 'Department of Pediatrics, Kansai Medical University, Nagasaki, Nagasaki-ken.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Osaka Medical College, Takatsuki, Osaka-fu.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pediatrics, Fukushima Medical University School of Medicine, Fukushima, Fukushima-ken.'}, {'ForeName': 'Soken', 'Initials': 'S', 'LastName': 'Go', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Tokyo Medical University, Shinjuku, Tokyo.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Murakami', 'Affiliation': 'Department of Psychosomatic medicine, Sakai Sakibana Hospital, Sakai, Osaka-fu, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14268']
18,32353174,Physical activity and cognition in young-onset Parkinson's disease.,"BACKGROUND


A relationship has been observed between physical activity and cognition in older-onset Parkinson's disease, as well as improvements in cognition after a physical activity intervention. To date, this has not been investigated in young-onset Parkinson's disease (YOPD).
OBJECTIVES


To examine the baseline relationship between physical activity and cognition in YOPD; and to examine whether a physical activity intervention can improve cognition in YOPD.
METHODS


Two interrelated online studies were conducted. In the first study, 132 participants with YOPD completed self-reported measures of physical activity, and objective and subjective measures of cognition. A subset of 38 participants was then randomly allocated to either a six-week physical activity intervention or control condition. Following the intervention, participants repeated the objective and subjective cognitive measures.
RESULTS


No relationship was found between self-reported physical activity and objective cognition; however, there was a relationship between physical activity and subjective cognition. Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not for memory. Furthermore, medium effect sizes were evident for objective measures of processing speed and small-medium effect sizes for planning and cognitive flexibility, although statistical significance was not reached.
CONCLUSIONS


In this first study investigating physical activity and cognition in YOPD, the results suggest that increased physical activity relates to improved processing speed and attention. Replication is recommended with a larger sample size. A longer, more intense physical activity manipulation and utilizing the study's strengths of online recruitment and intervention delivery are also recommended.",2020,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","['38 participants', ""young onset Parkinson's disease (YOPD"", ""young onset Parkinson's disease"", '132 participants with YOPD completed']","['physical activity intervention', 'six-week physical activity intervention or control condition']","['physical activity and objective cognition', 'Physical activity and cognition', 'physical activity and subjective cognition', 'processing speed and small-medium effect sizes for planning and cognitive flexibility', 'objective and subjective cognitive measures', 'self-report measures of physical activity, and objective and subjective measures of cognition', 'concentration, attention, and processing speed, but not memory']","[{'cui': 'C4275179', 'cui_str': 'Young onset Parkinson disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",132.0,0.0152447,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Biddiscombe', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ong', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kalinowski', 'Affiliation': 'Cogstate, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerryn E', 'Initials': 'KE', 'LastName': 'Pike', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",Acta neurologica Scandinavica,['10.1111/ane.13256']
19,32356211,Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial.,"OBJECTIVES


The aim of this study was to compare the antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries (S-ECC).
MATERIALS AND METHODS


The study was conducted in 92 children with S-ECC. Patients who completed dental treatment under general anaesthesia were included in the study. Patients were divided randomly into four groups: 5% sodium fluoride (SF) control group (n = 23), 5% SF with tricalcium phosphate (TCP) (n = 23), 5% SF with xylitol-coated calcium and phosphate (CXP) (n = 23) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (n = 23). Saliva mutans streptococci (MS) and lactobacilli (LB) levels were evaluated by taking saliva samples at baseline (T 0 ), 1 month (T 1 ) and 3 months (T 2 ) after treatment.
RESULTS


All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group. Only the TCP group exhibited significantly decrease MS and LB levels indicating less than 10 5  CFU at both T 1  and T 2  compared with the other groups (P < 0.05).
CONCLUSION


Fluoride varnish with TCP provided significantly more reduction in MS and LB levels than other fluoride varnishes.
CLINICAL RELEVANCE


Fluoride varnish with TCP had a significant antibacterial effect against cariogenic bacteria until the end of the third month. Long lasting antibacterial effect provides additional advantage for reducing bacteria levels in children.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03625310.",2020,All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group.,"['children with severe early childhood caries', 'children', 'children with severe early childhood caries (S-ECC', 'Patients who completed dental treatment under general anaesthesia were included in the study', '92 children with S-ECC']","['fluoride varnishes', 'sodium fluoride (SF) control group (n\xa0=\u200923), 5% SF with tricalcium phosphate (TCP) (n\xa0=\u200923), 5% SF with xylitol-coated calcium and phosphate (CXP) (n\xa0=\u200923) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'TCP', 'Fluoride varnish with TCP']","['MS and LB levels', 'antibacterial activity', 'Antibacterial activity', 'bacteria levels', 'Saliva mutans streptococci (MS) and lactobacilli (LB) levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",92.0,0.0392861,All groups showed a significant decrease in MS and LB levels at T 1  (P < 0.05) except the CXP group.,"[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkmen Almaz', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey. dt.merveerkmen@gmail.com.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Akbay Oba', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03300-w']
20,32289380,Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.,"BACKGROUND


We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen.
PATIENTS AND METHODS


Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors.
RESULTS


Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively.
CONCLUSIONS


We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.",2020,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","['white, black and Asian men with mCRPC treated with a DP-based regimen', 'men with mCRPC enrolled on these phase III clinical trials with DP', 'black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a', 'Men of Diverse Ethnic s with Metastatic Castration Resistant Prostate Cancer', 'Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified', 'Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined']",['docetaxel (D) and prednisone (P)-based regimen'],"['Median PSA PFS', 'Median PFS', 'progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",8820.0,0.269513,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Old Dominion University, Norfolk, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus San Rosa Hospital Medical Center, San Antonio, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.309']
21,32367561,Salivary tumor necrosis factor-alpha to detect the severity of erectile dysfunction: A randomized clinical trial.,"AIM


This study aimed to provide evidence on the impact of chronic periodontitis (CP) on the severity of erectile dysfunction (ED) through the assessment of the salivary level of tumor necrosis factor-alpha (TNF-α).
METHODS


140 patients with chronic periodontitis and erectile dysfunction were enrolled in this study and then randomly allocated to the control group (70 participants received delayed periodontal treatment) or test group (70 participants were subjected to immediate periodontal therapy). The assessment of the clinical and serological outcomes was done at baseline and 3 months postoperatively. This included pocket depth (PD), visible plaque, clinical attachment level (CAL), bleeding on probing (BOP), level of tumor necrosis factor-alpha (TNF-α), and the severity of erectile dysfunction. Periodontal therapy consists of oral hygiene instructions and single-visit scaling and root planing.
RESULTS


There were no significant differences regarding the serological and clinical outcomes at baseline between the two groups (p > .05). At 3-month follow-up, the PD, BOP, CAL, and visible dental plaque means in the control group were significantly higher than those in the test group (PD: 4.94 ± 0.647 mm vs. 4.25 ± 0.619 mm; BOP: 49.03 ± 29.98 vs. 6.20 ± 7.14; CAL: 4.96 ± 0.631 mm vs. 4.31 ± 0.591 mm; visible dental plaque: 48.49 ± 30.07 vs. 5.83 ± 6.51) (p = .00). Compared with baseline findings, both groups showed significant reductions in TNF-α in serum, salivary TNF-α, and severity of erectile dysfunction (p < .001).
CONCLUSION


The non-surgical periodontal therapy could significantly improve the severity of erectile dysfunction in addition to periodontal and serological parameters. Salivary TNF-α could be used as a new diagnostic tool to detect the severity of erectile dysfunction.",2020,The non-surgical periodontal therapy could significantly improve the severity of erectile dysfunction in addition to periodontal and serological parameters.,['140 patients with chronic periodontitis and erectile dysfunction'],['delayed periodontal treatment) or test group (70 participants were subjected to immediate periodontal therapy'],"['pocket depth (PD), visible plaque, clinical attachment level (CAL), bleeding on probing (BOP), level of tumor necrosis factor-alpha (TNF-α), and the severity of erectile dysfunction', 'serological and clinical outcomes', 'TNF-α in serum, salivary TNF-α, and severity of erectile dysfunction', 'severity of erectile dysfunction', 'PD, BOP, CAL, and visible dental plaque means']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",140.0,0.0487759,The non-surgical periodontal therapy could significantly improve the severity of erectile dysfunction in addition to periodontal and serological parameters.,"[{'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'El-Makaky', 'Affiliation': 'Faculty of Dentistry, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Abdalla Hawwam', 'Affiliation': 'Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Hifnawy', 'Affiliation': 'College of Dentistry, Taibah University, Saudi Arabia.'}]",Oral diseases,['10.1111/odi.13380']
22,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
23,32367416,Impact of spectral body imaging in patients suspected for occult cancer: a prospective study of 503 patients.,"OBJECTIVES


To investigate the diagnostic impact and performance of spectral dual-layer detector CT in the detection and characterization of cancer compared to conventional CE-CT.
METHODS


In a national workup program for occult cancer, 503 patients (286 females and 217 males) were prospectively enrolled for a contrast-enhanced spectral CT scan. The readings were performed with and without spectral data available. A minimum of 3 months between interpretations was implemented to minimize recall bias. The sequence of reads for the individual patient was randomized. Readers were blinded for patient identifiers and clinical outcome. Two radiologists with 9 and 33 years of experience performed the readings in consensus. If disagreement, a third radiologist with 11 years of experience determined the outcome of the reading RESULTS: Significantly more cancer findings were identified on the spectral reading. In 73 cases of proven cancer, we found a sensitivity of 89% vs 77% and a specificity of 77% vs 83% on spectral CT compared to conventional CT. A slight increase in reading time in spectral images of 82 s was found (382 vs 300, p < 0.001). For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries. And adding the spectral information to the reading gave a decrease in follow-up examination for diagnostic certainty (0.25 vs 0.81 per reading, p < 0.001).
CONCLUSION


The use of contrast-enhanced spectral CT increases the confidence of the radiologists in correct characterization of various lesions and minimizes the need for supplementary examinations.
KEY POINTS


• Spectral CT is associated with a higher sensitivity, but a slightly lower specificity compared to conventional CT. • Spectral CT increases the confidence of the radiologists. • The need for supplementary examinations is decreased, with only a slight increase in reading times.",2020,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","['503 patients', '503 patients (286 females and 217 males', 'patients suspected for occult cancer']","['contrast-enhanced spectral CT', 'spectral dual-layer detector CT', 'spectral body imaging']","['diagnostic certainty', 'reading time in spectral images', 'reading times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",503.0,0.0300193,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","[{'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev and Gentofte, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark. Michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Ebbesen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Thygesen', 'Affiliation': 'Department of Clinical Engineering, Central Denmark Region, Nørrebrogade 44, Building 2A, Aarhus, 8000, Denmark.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kruis', 'Affiliation': 'Philips Medical Systems, Clinical Science, CT, Veenpluis 4-6, Best, 5684, The Netherlands.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}]",European radiology,['10.1007/s00330-020-06878-7']
24,32361265,Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma.,"BACKGROUND


Necuparanib, a rationally engineered low-molecular-weight heparin, combined with gemcitabine/nab-paclitaxel showed an encouraging safety and oncologic signal in a phase Ib trial. This randomised multicentre phase II trial evaluates the addition of necuparanib or placebo to gemcitabine/nab-paclitaxel in untreated metastatic pancreatic ductal adenocarcinoma (PDAC).
PATIENTS AND METHODS


Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1. Patients were randomly assigned to necuparanib (5 mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel on days 1, 8 and 15 of 28-day cycles. The primary end-point was median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety.
RESULTS


One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to placebo arm. The futility boundary was crossed at a planned interim analysis, and the study was terminated by the Data Safety Monitoring Board. The median OS was 10.71 months (95% confidence interval [CI]: 7.95-11.96) for necuparanib arm and 9.99 months (95% CI: 7.85-12.85) for placebo arm (hazard ratio: 1.12, 95% CI: 0.66-1.89, P-value: 0.671). The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
CONCLUSION


The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. Safety was acceptable. No further development of necuparanib is planned although targeting the coagulation cascade pathway remains relevant in PDAC. NCT01621243.",2020,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","['One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to', 'untreated metastatic pancreatic ductal adenocarcinoma (PDAC', 'Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1', 'untreated metastatic pancreas ductal adenocarcinoma']","['gemcitabine/nab-paclitaxel', 'gemcitabine and nab-paclitaxel with necuparanib or placebo', 'necuparanib (5\xa0mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel', 'necuparanib or placebo to gemcitabine/nab-paclitaxel', 'placebo']","['median OS', 'haematologic toxicity', 'median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety', 'safety and oncologic signal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",110.0,0.686627,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: oreillye@mskcc.org.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Devalingam', 'Initials': 'D', 'LastName': 'Mahalingam', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Scottsdale, AZ, USA; ACCRU Research Consortium, Rochester, MN, USA.'}, {'ForeName': 'Spencer H', 'Initials': 'SH', 'LastName': 'Shao', 'Affiliation': 'Compass Oncology, Rose Quarter Cancer Center, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Rosano', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology, US Oncology Research, 910 East Houston Street, Tyler, TX 71702, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roach', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ryan', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.005']
25,32378956,Emotion regulation contagion: Stress reappraisal promotes challenge responses in teammates.,"The current research examined the interpersonal dynamics of emotion regulation in a stressful collaborative context. Little is known about how regulating one's own stress responses impacts teammates. In this article, we propose that individual efforts to regulate emotions can impact teammates for the better. We tested hypotheses arising from this claim using a dyadic experiment ( N  = 266) that assessed in vivo physiological stress responses during collaborative work (a face-to-face product design task) and then individual work (a product pitch to evaluators). Throughout the experiment, the manipulated teammate was randomly assigned to reappraise their stress arousal, suppress their emotional displays, or receive no instructions. The nonmanipulated teammate received no instructions in all experimental conditions. Stress reappraisal benefited both teammates, eliciting challenge-like physiological responses (higher cardiac output, lower total peripheral resistance) relative to the suppression and control conditions. These effects were observed during both collaborative and individual work. A mediation model suggested that face-to-face interpersonal effects of stress reappraisal fed forward to promote nonmanipulated teammates' improved stress responses during individual performance. Moreover, manipulated teammates' displays of positive and negative affect emerged as potential mechanisms for improvements in nonmanipulated teammates' stress responses in moderation analyses. Thus, participants benefited by interacting with a person who reappraised their stress as functional. This work has theoretical implications for the interpersonal dynamics of emotion regulation, and relevance for applied settings is also discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Stress reappraisal benefited both teammates, eliciting challenge-like physiological responses (higher cardiac output, lower total peripheral resistance) relative to the suppression and control conditions.",['participants benefited by interacting with a person who reappraised their stress as functional'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",[],[],,0.0132275,"Stress reappraisal benefited both teammates, eliciting challenge-like physiological responses (higher cardiac output, lower total peripheral resistance) relative to the suppression and control conditions.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oveis', 'Affiliation': 'Rady School of Management.'}, {'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Rady School of Management.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Ocampo', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hangen', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Jamieson', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. General,['10.1037/xge0000757']
26,32374395,Association of Neurodevelopmental Outcomes With Environmental Exposure to Cyclohexanone During Neonatal Congenital Cardiac Operations: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Cyclohexanone is an industrial solvent used as a coupling agent in medical plastics. Perioperative exposure to cyclohexanone could play a role in lower scores on measures of neurodevelopmental outcomes after neonatal cardiac operations.
Objective


To examine the presence and association of serum cyclohexanone level with neonatal cardiac operations and neurodevelopmental outcomes.
Design, Setting, and Participants


This ad hoc secondary analysis used data from the Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass randomized clinical trial. The cohort included neonates younger than 31 days and with at least 37 weeks postgestational age at surgical treatment who were enrolled at a single center between June 1, 2012, and October 31, 2016, and who had completed a neurodevelopmental assessment at age 12 months. Data were analyzed from July 8 to August 20, 2019.
Exposures


Serum cyclohexanone and its metabolites were measured preoperatively (prior to skin incision), postoperatively (immediately after the surgical procedure was completed), and 12 hours postoperatively. Cyclohexanone and the molar sum of its metabolites were examined at each point and as a geometric mean of all 3 points.
Main Outcomes and Measures


Neurodevelopment was assessed at age 12 months with the Bayley Scales of Infant and Toddler Development III, assessing cognitive, language, and motor function composite scores standardized to a population mean (SD) of 100 (15). Linear regression models were used to determine covariate-adjusted differences in 12-month cognitive, language, and motor composite scores per interquartile range increase in cyclohexanone level or summed metabolite molar concentrations.
Results


Among 85 included neonates, mean (SD) age at surgical treatment was 9.7 (5.3) days, 49 (58%) were boys, and 54 (64%) underwent corrective repair. Mean (SD) Bayley Scales of Infant and Toddler Development III composite scores were 108.2 (12.2) for cognitive function, 104.7 (11.0) for language function, and 94.7 (15.7) for motor function. Median (interquartile range) cyclohexanone levels increased approximately 3-fold from immediately prior to surgical treatment to immediately after surgical treatment (572 [389-974] vs 1744 [1469-2291] μg/L; P = .001). In adjusted analyses, higher geometric mean cyclohexanone levels were associated with significantly lower composite scores for cognitive (-4.23; 95% CI, -7.39 to -1.06; P = .01) and language (-3.65; 95% CI, -6.41 to -0.88; P = .01) function. The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
Conclusions and Relevance


The findings of this secondary analysis of a randomized clinical trial suggest that infants who underwent neonatal cardiac surgical treatment with cardiopulmonary bypass had substantial cyclohexanone levels, which were associated with adverse neurodevelopmental function at age 12 months.
Trial Registration


ClinicalTrials.gov identifier: NCT01579513.",2020,"The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
","['Neonates Undergoing Cardiopulmonary Bypass randomized clinical trial', 'cohort included neonates younger than 31 days and with at least 37 weeks postgestational age at surgical treatment who were enrolled at a single center between June 1, 2012, and October 31, 2016, and who had completed a neurodevelopmental assessment at age 12 months', '85 included neonates', 'Neonatal Congenital Cardiac Operations']","['cyclohexanone', 'neonatal cardiac surgical treatment with cardiopulmonary bypass', 'Environmental Exposure to Cyclohexanone', 'Cyclohexanone', 'Corticosteroid Therapy']","['adverse neurodevelopmental function', 'Median (interquartile range) cyclohexanone levels', 'composite scores for motor function', 'Mean (SD) Bayley Scales of Infant and Toddler Development III composite scores', 'neurodevelopmental outcomes', 'Exposures\n\n\nSerum cyclohexanone and its metabolites', 'Bayley Scales of Infant and Toddler Development III, assessing cognitive, language, and motor function composite scores standardized to a population mean (SD) of 100 (15', 'geometric mean cyclohexanone levels']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010571', 'cui_str': 'Cyclohexanones'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0014412', 'cui_str': 'Environmental exposure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0010571', 'cui_str': 'Cyclohexanones'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100'}]",,0.168514,"The difference in composite scores for motor function among infants with higher geometric mean cyclohexanone levels was not statistically significant(-3.93, 95% CI: -8.19 to 0.33, P = .07).
","[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Everett', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Buckley', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Environmental Health and Engineering, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': ""Molecular Determinants Core, Johns Hopkins All Children's Hospital, St Petersburg, Florida.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Griffiths', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Bembea', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Medical University of South Carolina; Charleston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4070']
27,32307733,Double decentred lenses in an eye: a therapeutic dilemma in Marfan syndrome.,,2020,,['Marfan syndrome'],[],[],"[{'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]",[],[],,0.0490559,,"[{'ForeName': 'Wei-Shan', 'Initials': 'WS', 'LastName': 'Tsai', 'Affiliation': 'Department of Ophthalmology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Yuan-Chieh', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Fang-Ling', 'Initials': 'FL', 'LastName': 'Chang', 'Affiliation': 'Department of Ophthalmology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Ming-Shan', 'Initials': 'MS', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}]",Clinical & experimental optometry,['10.1111/cxo.13075']
28,32364838,Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study.,"PURPOSE


We compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex™ Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.
MATERIALS AND METHODS


This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J® stent removal at day (D) 20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation.
RESULTS


The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p <0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers.
CONCLUSIONS


The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.",2020,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"['patients who require stenting for stone disease', '141 patients treated with fURS for renal stones', 'Patients Undergoing Flexible Ureteroscopy for Kidney Stone']","['silicone DJ stents', 'flexible ureteroscopy (fURS', 'hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex TM  Plus stent (Boston Scientific', 'flexible ureteroscopy', 'Materials and Methdos', 'Silicone Hydrocoated Double Loop Ureteral Stent', 'silicone Imajin® hydro stents', 'Percuflex TM']","['USSQ Body Pain Index recorded before DJ removal at day 20 (D20', 'Symptoms and Quality of Life', 'USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation', 'patient discomfort', 'Mean (SD) USSQ body pain scores', 'USSQ urinary symptoms scores at D2, D7 and D20', 'pain and discomfort', 'adverse events and safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0070387', 'cui_str': 'percuflex TM'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",141.0,0.171524,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Urology Department, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Ventimiglia', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology; URI; IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Steeve', 'Initials': 'S', 'LastName': 'Doizi', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Kleinclauss', 'Affiliation': 'Department of Urology and Renal Transplantation, CHRU Besancon, Besancon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Letendre', 'Affiliation': 'Maisonneuve-Rosemont Hospital, Urology, Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cloutier', 'Affiliation': 'University Hospital Centre of Quebec City, Urology, Quebec, Quebec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}]",The Journal of urology,['10.1097/JU.0000000000001098']
29,32379333,Association of Individual-Level Factors With Visual Outcomes in Optic Neuritis: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Using corticosteroids to treat acute demyelinating optic neuritis has been identified as an area for shared decision-making. However, no analysis exists to support personalized shared decision-making that considers long- and short-term treatment benefits.
Objective


To develop models of individual-level visual outcomes for patients with optic neuritis.
Design, Setting, and Participants


This secondary analysis of the Optic Neuritis Treatment Trial (ONTT), a randomized clinical trial, was performed at 14 academic eye centers and 1 large community eye center. Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included. Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling.
Exposures


Intravenous corticosteroids vs placebo.
Main Outcomes and Measures


Visual acuity (VA) at 1 year. Secondary outcomes were 1-year contrast sensitivity (CS) and VA and CS at 15 and 30 days. Independent variables included age, sex, race, multiple sclerosis status, optic neuritis episodes in the fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness, treatment group, and baseline VA or CS.
Results


Of the 455 participants, median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white. For 410 participants (90.1%) with 1-year outcomes, median VA improved from 20/66 (IQR, 20/28-20/630) at enrollment to 20/17 (IQR, 20/14-20/21) at 1 year. Baseline VA was the primary variable associated with 1-year VA (regression coefficient, 0.056 [95% CI, 0.008-0.103]; P = .02) if baseline VA was better than count fingers (CF). At 15 days, baseline VA and treatment status were associated with VA in those participants with baseline VA better than CF (regression coefficient, 0.305 [95% CI, 0.231-0.380]; F = 9.42; P < .001). However, the difference of medians (20/18 [95% CI, 20/17-20/19] with intravenous corticosteroids vs 20/23 [95% CI, 20/21-20/26] with placebo) was small for the median VA (20/66) in the trial. Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
Conclusions and Relevance


In this study, long-term VA was associated with severity of baseline vision loss. Early benefits with intravenous corticosteroid treatment were limited to participants with baseline VA better than CF. However, the early, temporary benefit of intravenous corticosteroids is of questionable clinical significance and should be weighed against potential harms.",2020,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","['14 academic eye centers and 1 large community eye center', '455 participants', ' median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white', 'Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included', 'Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling', 'patients with optic neuritis', 'Optic Neuritis']","['corticosteroids vs placebo', 'corticosteroids', 'intravenous corticosteroid', 'placebo']","['Measures\n\n\nVisual acuity (VA', '1-year contrast sensitivity (CS) and VA and CS', 'severity of baseline vision loss', 'fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness', 'median VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029134', 'cui_str': 'Optic neuritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.653426,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","[{'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'De Lott', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Costello', 'Affiliation': 'Section of Ophthalmology, Department of Clinical Neurosciences and Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wayne T', 'Initials': 'WT', 'LastName': 'Cornblath', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Trobe', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kerber', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4339']
30,32371123,Health-related quality of life after chemotherapy with or without rituximab in primary central nervous system lymphoma patients: results from a randomised phase III study.,"BACKGROUND


The impact of rituximab on health-related quality of life (HRQoL) in primary central nervous system lymphoma patients is not well known. We determined the impact of rituximab added to standard high-dose methotrexate-based treatment on HRQoL in patients in a large randomised trial.
PATIENTS AND METHODS


Patients from a large phase III trial (HOVON 105/ALLG NHL 24), randomly assigned to receive standard chemotherapy with or without rituximab and followed by 30 Gy whole brain radiotherapy (WBRT) in patients ≤60 years, completed the EORTC QLQ-C30 and QLQ-BN20 questionnaires before and during treatment, and up to 24 months of follow-up or progression. Differences between treatment arms over time in global health status, role functioning, social functioning, fatigue, and motor dysfunction were assessed. Differences ≥10 points were deemed clinically relevant. The effect of WBRT on HRQoL was analysed in irradiated patients.
RESULTS


A total of 160/175 patients eligible for the HRQoL study completed at least one questionnaire and were included. Over time, scores improved statistically significantly and were clinically relevant in both arms. Between arms, there were no differences on any scale (range: -3.8 to +4.0). Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared with baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively). In irradiated patients (n = 59), scores in all preselected scales, except motor dysfunction, remained stable up to 24 months compared with shortly after WBRT, overall mean difference ranging between 0.02 and 4.570.
CONCLUSION


Compared with baseline, treatment resulted in improved HRQoL scores. The addition of rituximab to standard chemotherapy did not impact HRQoL over time. WBRT did not result in deterioration of HRQoL in the first 2 years.",2020,"Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared to baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively).","['160/175 patients eligible for the HRQoL study completed at least one questionnaire and were included', 'Patients from a large phase III trial (HOVON 105/ALLG NHL 24', 'irradiated patients', 'primary central nervous system lymphoma patients']","['standard chemotherapy with or without rituximab and followed by 30Gy whole brain radiotherapy (WBRT', 'chemotherapy with or without rituximab', 'rituximab to standard chemotherapy', 'rituximab', 'WBRT', 'rituximab added to standard high-dose methotrexate-based treatment']","['health-related quality of life (HRQoL', 'fatigue and motor dysfunction', 'HRQoL', 'global health status, role functioning, social functioning, fatigue, and motor dysfunction', 'HRQoL scores', 'deterioration of HRQoL', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.17791,"Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared to baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands. Electronic address: m.vandermeulen.2@erasmusmc.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, Australia; University of Western Australia, Crawley, Australia.'}, {'ForeName': 'W B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Baars', 'Affiliation': 'Department of Hemato-Oncology, Antoni van Leeuwenhoek Hospital/Dutch Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Mason', 'Affiliation': 'Department of Hematology, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beijert', 'Affiliation': 'Department of Radiotherapy, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M J B', 'Initials': 'MJB', 'LastName': 'Taphoorn', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'J E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.014']
31,32361963,Development and Pilot Test of a Virtual Reality Respiratory Biofeedback Approach.,"Breathing exercises with biofeedback have benefits over breathing exercises without biofeedback. However, the traditional measurement of respiratory signals that is required as part of feeding back the breath incurs high cost and effort. We propose a novel virtual reality (VR) based approach to respiratory biofeedback that utilizes the positionally tracked hand controllers integrated into modern VR systems to capture and feedback the respiration-induced abdominal movements. In a randomized controlled laboratory study, we investigated the feasibility and efficacy of the developed biofeedback algorithm. In total, 72 participants performed a short breathing exercise in VR with or without respiratory biofeedback. The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia. This evidences that the novel biofeedback approach is low-cost, unobtrusive, usable and effective in increasing breath awareness and promoting slow diaphragmatic breathing in the context of VR-based breathing exercises. Future studies need to investigate the broader applicability and long-term effects.",2020,"The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia.",['72 participants performed a'],"['short breathing exercise in VR with or without respiratory biofeedback', 'novel virtual reality (VR) based approach to respiratory biofeedback that utilizes the positionally tracked hand controllers integrated into modern VR systems to capture and feedback the respiration-induced abdominal movements', 'Virtual Reality Respiratory Biofeedback Approach']","['feasibility and efficacy', 'slow diaphragmatic breathing and an increased respiratory sinus arrhythmia']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}]",72.0,0.0136611,"The feedback integration resulted in a satisfactory user experience, a heightened breath awareness, a greater focus on slow diaphragmatic breathing and an increased respiratory sinus arrhythmia.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Blum', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany. johannes.blum@psychologie.uni-freiburg.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rockstroh', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Albert-Ludwigs-Universität Freiburg, Engelbergerstr. 41, 79106, Freiburg, Germany.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09468-x']
32,32372277,Preventive effect of low-dose landiolol on postoperative atrial fibrillation study (PELTA study).,"OBJECTIVE


To investigate the efficacy of prophylactic administration of low-dose landiolol on postoperative atrial fibrillation (POAF) in patients after cardiovascular surgery.
METHODS


Consecutive 150 patients over 70 years of age who underwent cardiovascular surgery for valvular, ischemic heart, and aortic diseases were enrolled in this single-center prospective randomized control study from 2010 to 2014. They were assigned to three treatment groups: 1γ group (landiolol at 1 μg/kg/min), 2γ group (landiolol at 2 μg/kg/min), or control group (no landiolol). In the two landiolol groups, landiolol hydrochloride was intravenously administered for a period of 4 days postoperatively. Electrocardiography was continuously monitored during the study period, and cardiologists eventually assessed whether POAF occurred or not.
RESULTS


POAF occurred in 24.4% of patients in the control group, 18.2% in 1γ group, and 11.1% in 2γ group (p = 0.256). Multivariate logistic regression analysis showed that the incidence of POAF tended to decrease depending on the dose of landiolol (trend-p = 0.120; 1γ group: OR = 0.786, 95% CI 0.257-2.404; 2γ group: OR = 0.379, 95% CI 0.112-1.287). Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004).
CONCLUSIONS


These findings indicate that prophylactic administration of low-dose landiolol may not be effective for preventing the occurrence of POAF in overall patients after cardiovascular surgery, but the administration could be beneficial to female patients, patients not using ARBs preoperatively, and those after valvular surgery.",2020,"Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004).
","['patients after cardiovascular surgery', 'Consecutive', '150 patients over 70\xa0years of age who underwent cardiovascular surgery for valvular, ischemic heart, and aortic diseases were enrolled in this single-center prospective randomized control study from 2010 to 2014']","['Electrocardiography', '1γ group (landiolol at 1\xa0μg/kg/min), 2γ group (landiolol at 2\xa0μg/kg/min), or control group (no landiolol', 'landiolol hydrochloride', 'low-dose landiolol']","['postoperative atrial fibrillation (POAF', 'POAF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003493', 'cui_str': 'Disorder of aorta'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.097828,"Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004).
","[{'ForeName': 'Konosuke', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Research Division of Sciences for Aortic Disease, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Akiyama', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Katahira', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kaiho', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tsuji', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Saiki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. yoshisaiki@med.tohoku.ac.jp.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01364-9']
33,32376034,The effect of function-focused care on long-term care workers in South Korea.,"The purpose of this study was to identify the effects of the Korean Function-Focused Care Program (K-FFCP) for residents of long-term care facilities (LTCRs) on long-term care workers' (LTCWs) knowledge, self-efficacy, and outcome expectations about function-focused care, as well as on their job satisfaction. The study adopted a quasi-experimental repeated-measures design. Participants included 50 LTCWs from two long-term care facilities (24 in the experimental group and 26 in the control group). Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction. Outcomes that could not be measured using scales were assessed through a focus group interview. The results suggest that LTCWs would benefit from a long-term educational program on function-focused care.",2020,"Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction.","['residents of long-term care facilities (LTCRs', 'Participants included 50 LTCWs from two long-term care facilities (24 in the experimental group and 26 in the control group', 'long-term care workers in South Korea']","['Korean Function-Focused Care Program (K-FFCP', 'LTCWs']","['knowledge, efficacy, outcome expectation, and job satisfaction']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",50.0,0.0158224,"Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction.","[{'ForeName': 'Dukyoo', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': 'College of Nursing, Ewha Womans University, 309 Hellen hall, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 120-750, Republic of Korea. Electronic address: dyjung@ewha.ac.kr.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'De Gagne', 'Affiliation': 'Duke University School of Nursing, United States. Electronic address: jennie.degagne@duke.edu.'}, {'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Hunter-Bellevue School of Nursing, Hunter College, CUNY, United States.'}, {'ForeName': 'Hyesoon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, 309 Hellen hall, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 120-750, Republic of Korea. Electronic address: sunnysoonlee@nate.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.03.017']
34,32376981,Longitudinal follow-up after telephone disclosure in the randomized COGENT study.,"PURPOSE


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


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


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


Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.",2020,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","['Four hundred seventy-three participants were randomized to TD and 497 to IPD', 'Adults who were proceeding with germline cancer genetic testing']","['telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD)\xa0(i.e., usual care']","['cognitive, affective, or behavioral outcomes', 'Mammography']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",473.0,0.0669023,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","[{'ForeName': 'Madison K', 'Initials': 'MK', 'LastName': 'Kilbride', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Biostatistics and Bioinformatics Facility, Philadelphia, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Patrick-Miller', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Generosa', 'Initials': 'G', 'LastName': 'Grana', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Olufunmilayo I', 'Initials': 'OI', 'LastName': 'Olopade', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fetzer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dana F', 'Initials': 'DF', 'LastName': 'Clark', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Gaber', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Gulden', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Horte', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Long', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Shreshtha', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattie', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McKenna', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rainey', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rybak', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Savage', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seelaus', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stoll', 'Affiliation': 'Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Stopfer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Xinxin Shirley', 'Initials': 'XS', 'LastName': 'Yao', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Bradbury', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA. Angela.Bradbury@uphs.upenn.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-0808-3']
35,31813273,Primary Care Practitioner Training in Child and Adolescent Psychiatry (PTCAP): A Cluster-Randomized Trial.,"OBJECTIVES


Rural primary care practitioners (PCPs) have a pivotal role to play in frontline pediatric mental health care, given limited options for referral and consultation. Yet they report a lack of adequate training and confidence to provide this care. The aim of this study was to test the effectiveness of the Practitioner Training in Child and Adolescent Psychiatry (PTCAP) program, which was designed to enhance PCPs' pediatric mental health care confidence. The program includes brief therapeutic skills and practice guidelines PCPs can use to address both subthreshold concerns and diagnosable conditions, themselves.
METHODS


The study design was a pilot, cluster-randomized, multicenter trial. Practices were randomly assigned to intervention ( n  practices = 7;  n  PCPs = 42) or to wait-list control ( n  practices = 6;  n  PCPs = 34). The intervention involved 8 hr of training in practice guidelines and brief therapeutic skills for depression, anxiety, attention deficit hyperactivity disorder, and behavioral disorders with case discussion and video examples, while the control practiced as usual. A linear random-effects model controlling for clustering and baseline was carried out on the individual-level data to examine between-group differences in the primary (i.e., confidence) and secondary (i.e., attitude and knowledge) outcomes at 1-week follow-up.
RESULTS


Findings were a statistically significant difference in the primary outcomes. Compared to the control group, the intervention group indicated significantly greater confidence in managing  diagnosable  conditions ( d  = 1.81) and  general  concerns ( d  = 1.73), as well as in making necessary referrals ( d  = 1.27) and obtaining consults ( d  = 0.74). While the intervention did not significantly impact secondary outcomes (attitudes and knowledge), regression analysis indicated that the intervention may have increased confidence, in part, by ameliorating the adverse impact of negative mental health care attitudes.
CONCLUSION


PTCAP enhances PCPs' child/youth mental health care confidence in managing both general and diagnosable concerns. However, an 8-hr session focused on applying brief therapeutic skills was insufficient to significantly change attitudes and knowledge. Formal testing of PTCAP may be warranted, perhaps using more intensive training and including outcome assessments capable of determining whether increased PCP confidence translates to more effective management and better patient outcomes.",2020,"Compared to the control group, the intervention group indicated significantly greater confidence in managing  diagnosable  conditions ( d  = 1.81) and  general  concerns ( d  = 1.73), as well as in making necessary referrals ( d  = 1.27) and obtaining consults ( d  = 0.74).","['in Child and Adolescent Psychiatry (PTCAP', 'Rural primary care practitioners (PCPs', 'Child and Adolescent Psychiatry (PTCAP) program']","['Practitioner Training', 'intervention ( n  practices = 7;  n  PCPs = 42) or to wait-list control', 'PTCAP', 'Primary Care Practitioner Training']","['adverse impact of negative mental health care attitudes', 'greater confidence in managing  diagnosable  conditions']","[{'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0709654,"Compared to the control group, the intervention group indicated significantly greater confidence in managing  diagnosable  conditions ( d  = 1.81) and  general  concerns ( d  = 1.73), as well as in making necessary referrals ( d  = 1.27) and obtaining consults ( d  = 0.74).","[{'ForeName': 'Stacey D', 'Initials': 'SD', 'LastName': 'Espinet', 'Affiliation': 'Department of Psychiatry, Schulich School of Medicine & Dentistry, Centre for Education Research and Innovation, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gotovac', 'Affiliation': 'Division of Child and Adolescent Psychiatry, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Sommer', 'Initials': 'S', 'LastName': 'Knight', 'Affiliation': 'Department of Psychiatry, Schulich School of Medicine & Dentistry, Centre for Education Research and Innovation, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Wissow', 'Affiliation': 'School of Medicine, University of Washington, DC, USA.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': 'Department of Family Medicine, Centre for Studies in Family Medicine, The University of Western Ontario, Ontario, Canada.'}, {'ForeName': 'Lorelei', 'Initials': 'L', 'LastName': 'Lingard', 'Affiliation': 'Centre for Education Research and Innovation, Health Sciences Addition, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': ""Discipline of Psychiatry, Faculty of Medicine, Memorial University of Newfoundland, Saint John's, Newfoundland, Canada.""}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719890161']
36,32379487,A Randomized Sham-controlled Trial of 1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) of the Right Dorsolateral Prefrontal Cortex in Civilian Post-traumatic Stress Disorder: Un essai randomisé contrôlé simulé de stimulation magnétique transcrânienne repetitive (SMTr) de 1 Hz et 10 Hz du cortex préfrontal dorsolatéral droit dans le trouble de stress post-traumatique chez des civils.,"OBJECTIVE


Despite effective psychological and pharmacological treatments, there is a large unmet burden of illness in post-traumatic stress disorder (PTSD). Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention and a putative treatment strategy for PTSD. The evidence base to date suggests that rTMS targeting the dorsolateral prefrontal cortex (DLPFC), in particular the right DLPFC, leads to improvements in PTSD symptoms. However, optimal stimulation parameters have yet to be determined. In this study, we examine the efficacy of high- and low-frequency rTMS of the right DLPFC using a randomized, double-blind, sham-controlled design in civilian PTSD.
METHODS


We conducted a 2-week single-site randomized sham-controlled trial of rTMS targeting the right DLPFC. We recruited civilians aged 19 to 70 with PTSD and randomized subjects with allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS. The primary outcome was improvement in Clinician Administered PTSD Scale-IV (CAPS-IV). Secondary outcomes included change in depressive and anxiety symptoms.
RESULTS


We recruited 31 civilians with PTSD. One 1-Hz-treated patient developed transient suicidal ideation. Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group. This was not attributable to changes in anxious or depressive symptomatology. Ten-Hz stimulation appeared to improve depressive symptoms compared to sham.
CONCLUSION


Low-frequency rTMS is efficacious in the treatment of civilian PTSD. Our data suggest that high-frequency rTMS of the right DLPFC is worthy of additional investigation for the treatment of depressive symptoms comorbid with PTSD.",2020,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"['We recruited civilians aged 19 to 70 with PTSD and randomized subjects with', '31 civilians with PTSD', 'Civilian Post-traumatic Stress Disorder']","['allocation concealment to daily 1-Hz rTMS, 10-Hz rTMS, or sham rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', '1-Hz and 10-Hz Repetitive Transcranial Magnetic Stimulation (rTMS']","['CAPS-IV symptoms', 'anxious or depressive symptomatology', 'Clinician Administered PTSD Scale-IV (CAPS-IV', 'change in depressive and anxiety symptoms', 'transient suicidal ideation', 'depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.283303,Analyses revealed significant improvement in CAPS-IV symptoms in the 1-Hz group relative to sham (Hedges'  g  = -1.07) but not in the 10-Hz group.,"[{'ForeName': 'Kawai', 'Initials': 'K', 'LastName': 'Leong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Ong', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zwicker', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': '380154Vancouver General Hospital, British Columbia, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, 8166University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McGirr', 'Affiliation': 'Department of Psychiatry, 2129University of Calgary, Alberta, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720923064']
37,32383748,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.,"Importance


Zinc supplementation can reduce alcohol-related microbial translocation and inflammation.
Objective


To assess whether zinc supplementation reduces markers of mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression in people with heavy alcohol use who are living with HIV/AIDS.
Design, Setting, and Participants


This study is a double-blinded placebo-controlled randomized clinical trial of zinc supplementation among participants recruited from 2013 to 2015. Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia. Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption. Data analysis was performed from February 2017 to February 2020.
Intervention


Pharmacy-grade zinc gluconate supplementation (15 mg for men and 12 mg for women, taken daily by mouth for 18 months) was compared with a placebo.
Main Outcomes and Measures


The primary outcome was mortality risk measured as a change in Veterans Aging Cohort Study (VACS) Index score between baseline and 18 months. The VACS Index scores range from 0 to 164, with higher scores indicating higher mortality risk. Secondary outcomes were change in CD4 cell count between baseline and 18 months, the assessment of cardiovascular disease risk (Reynolds Risk Score, which ranges from 0% to 100%, with higher scores indicating higher risk), and changes in inflammatory or microbial translocation biomarkers at 18 months. Adjusted linear regression analyses were performed.
Results


A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126 were randomized to receive zinc, and 128 were randomized to receive placebo. Participants had high CD4 cell counts (mean [SD], 521 [292] cells/mm3), and 188 (74%) reported heavy drinking in the past week. In the main analyses, zinc supplementation did not affect changes in the VACS Index score at 18 months (change for zinc, mean [SD], 0.49 [14.6]; median [interquartile range], 0.0 [-7.0 to 6.0]; change for placebo, mean [SD], 5.5 [17.2]; median [interquartile range], 6.0 [-6.0 to 14.0]; adjusted mean difference [AMD], -4.68; 95% CI, -9.62 to 0.25; P = .06) or any secondary outcomes, including change in CD4 cell count (AMD, 41.8 cells/mm3; 95% CI, -20.3 to 103.8 cells/mm3; P = .19), Reynolds Risk Score (AMD, -0.014; 95% CI, -0.167 to 0.139; P = .85), interleukin-6 level (AMD, -0.13 pg/mL; 95% CI, -0.38 to 0.11 pg/mL; P = .30), dimerized plasmin fragment D level (AMD, -0.21 μg/mL fibrinogen equivalent units; 95% CI, -0.48 to 0.07 μg/mL fibrinogen equivalent units; P = .14), soluble CD14 level (AMD, -38.01 ng/mL; 95% CI, -166.90 to 90.88 ng/mL; P = .56), intestinal fatty acid binding protein level (AMD, 0.08 pg/mL; 95% CI, -0.07 to 0.22 pg/mL; P = .32), and lipopolysaccharide binding protein level (AMD, -0.09 ng/mL; 95% CI, -0.23 to 0.06 ng/mL; P = .24). In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
Conclusions and Relevance


Zinc supplementation did not reduce mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation in people with heavy alcohol use who are living with HIV/AIDS. Zinc supplementation did not change the VACS Index score but may have been limited by low adherence.
Trial Registration


ClinicalTrials.gov Identifier: NCT01934803.",2020,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","['participants recruited from 2013 to 2015', 'Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption', 'HIV-Positive Adults With Heavy Alcohol Use', 'Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia', 'A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126', 'people with heavy alcohol use who are living with HIV/AIDS']","['Zinc supplementation', 'zinc supplementation', 'Zinc Supplementation vs Placebo', 'Intervention\n\n\nPharmacy-grade zinc gluconate supplementation', 'placebo']","['Mortality Risk and HIV Disease Progression', 'mortality risk', 'cardiovascular disease risk (Reynolds Risk Score', 'change in CD4 cell count', 'high CD4 cell counts', 'VACS Index score', 'changes in inflammatory or microbial translocation biomarkers', 'soluble CD14 level', 'mortality risk measured as a change in Veterans Aging Cohort Study (VACS', 'VACS Index scores range', 'interleukin-6 level', 'adherence rate to zinc supplementation', 'lipopolysaccharide binding protein level', 'mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression', 'Index score', 'intestinal fatty acid binding protein level', 'heavy drinking', 'dimerized plasmin fragment D level', 'mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation', 'Reynolds Risk Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",126.0,0.736847,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Coleman', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'So-Armah', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4330']
38,32381373,"Effectiveness of nicotine patch for the control of pain, oedema, and trismus following third molar surgery: a randomized clinical trial.","The aim of this study was to evaluate the effectiveness of a nicotine patch for the control of pain, oedema, and trismus following lower third molar surgery. A prospective, randomized, triple-blind, split-mouth trial was performed involving 20 patients who underwent two surgical procedures at different times. A patch containing 14mg nicotine was used in the experimental group, whereas a patch without nicotine (placebo) was used in the control group. The nicotine patch was effective at controlling pain after 4hours and 8hours (P= 0.023 and P= 0.005, respectively). The nicotine patch also had a significant effect on the control of oedema at 24 hours (P= 0.002), 48 hours (P= 0.001), and 72 hours (P= 0.005) following the intervention. Postoperative mouth opening was significantly greater among the patients who received the nicotine patch after 72 hours and 7 days. The number of rescue analgesics required was lower (P= 0.026) and the level of satisfaction was significantly higher (P= 0.008) when the patch was used, although higher levels of nausea were found in the nicotine group (P= 0.031 at 30 minutes, P= 0.008 at 4 hours). The nicotine patch was effective at controlling pain, oedema, and trismus following third molar surgery.",2020,"The nicotine patch was effective at controlling pain after 4hours and 8hours (P= 0.023 and P= 0.005, respectively).","['following third molar surgery', '20 patients who underwent two surgical procedures at different times', 'following lower third molar surgery']","['nicotine patch', 'patch without nicotine (placebo', 'nicotine']","['levels of nausea', 'number of rescue analgesics', 'control of oedema', 'Postoperative mouth opening', 'level of satisfaction', 'pain, oedema, and trismus']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3839628', 'cui_str': 'Level of nausea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",20.0,0.0883904,"The nicotine patch was effective at controlling pain after 4hours and 8hours (P= 0.023 and P= 0.005, respectively).","[{'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Landim', 'Affiliation': 'Maxillofacial Surgery and Trauma, Pernambuco School of Dentistry, University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Laureano Filho', 'Affiliation': 'Maxillofacial Surgery and Trauma, Pernambuco School of Dentistry, University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nascimento', 'Affiliation': 'Maxillofacial Surgery and Trauma, Pernambuco School of Dentistry, University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'do Egito Vasconcelos', 'Affiliation': 'Maxillofacial Surgery and Trauma, Pernambuco School of Dentistry, University of Pernambuco, Camaragibe, Pernambuco, Brazil. Electronic address: belmiro@pesquisador.cnpq.br.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.08.013']
39,32383337,Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial.,"OBJECTIVE


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


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


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


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


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


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


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


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


Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability.",2020,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","['Pregnancy-related deaths were prospectively collected from routine data sources and active case finding', '10 sites across eight low and middle-income countries in sub-Saharan Africa, India and Haiti', 'Half of maternal deaths (50.6%; n=505) occurred in women aged 20-29, 10.3% under 20 years (n=103), 34.5% aged 30-39 (n=344) and 4.6% (n=46) aged ≥40', 'women presenting for maternity care were eligible for inclusion']",[],"['Incidence and characteristics of pregnancy-related death', '998 maternal deaths', 'availability of key obstetric resources and the rate of pregnancy-related death', 'Pregnancy-related death, place, timing and age of maternal death and neonatal outcomes', 'sepsis', 'hypertensive disorders of pregnancy']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]",,0.351709,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Kumsa', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nakimuli', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16309']
40,32380428,Indirect treatment comparison of nivolumab versus placebo for the adjuvant treatment of melanoma.,"INTRODUCTION


Until recently, adjuvant treatment options for stage III and IV resectable melanoma have been limited. Patients were often managed through routine surveillance. The phase III randomised controlled trial (RCT) CheckMate 238 (238) demonstrated the safety and efficacy of nivolumab as an adjuvant treatment for melanoma in patients with stage IIIB/C or IV disease (American Joint Committee on Cancer [AJCC], 7th edition) versus ipilimumab. The study objective was to estimate the relative efficacy, safety and health-related quality of life (HRQoL) between nivolumab and routine surveillance.
METHODS


Indirect treatment comparisons (ITCs) of nivolumab versus placebo were constructed using data from 238 and EORTC 18071. EORTC 18071 is a phase III RCT comparing ipilimumab with placebo in patients with resected stage IIIA-IIIC melanoma (AJCC, 6th edition). ITCs were performed using the Bucher comparison method and patient-level data for efficacy, safety and HRQoL.
RESULTS


For the efficacy outcomes, nivolumab performed significantly better than placebo for recurrence-free survival (hazard ratio [HR]: 0.53 [95% confidence interval {CI}: 0.41, 0.68]) and distant metastases-free survival (HR: 0.59 [95% CI: 0.44, 0.78]). Safety ITCs indicated that patients receiving nivolumab had a greater hazard of experiencing an adverse event (AE) and AEs leading to treatment discontinuation, whereas there was a non-significant increased hazard of experiencing a serious AE. HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
CONCLUSION


Nivolumab was associated with significantly improved efficacy outcomes versus placebo, whereas maintaining patient's overall HRQoL. Across the different analysis and populations, there was a high level of consistency in the effect size.",2020,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","['patients with resected stage IIIA-IIIC melanoma (AJCC, 6th edition', 'patients with stage IIIB/C or IV disease (American Joint Committee on Cancer [AJCC], 7th edition) versus', 'melanoma']","['nivolumab versus placebo', 'nivolumab', 'ipilimumab with placebo', 'ipilimumab', 'placebo']","['relative efficacy, safety and health-related quality of life (HRQoL', 'hazard of experiencing a serious AE', 'distant metastases-free survival', 'hazard of experiencing an adverse event (AE) and AEs leading to treatment discontinuation', 'safety and efficacy', 'recurrence-free survival (hazard ratio [HR', 'efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.626136,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hemstock', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK. Electronic address: mhemstock@bresmed.com.'}, {'ForeName': 'Adenike', 'Initials': 'A', 'LastName': 'Amadi', 'Affiliation': 'Bristol-Myers Squibb, Uxbridge, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kupas', 'Affiliation': 'Bristol-Myers Squibb GmbH & Co. KGaA, Munich, Germany.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Roskell', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Kotapati', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Kyna', 'Initials': 'K', 'LastName': 'Gooden', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'University of Oxford, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen and German Cancer Consortium, Heidelberg, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.011']
41,32380427,Differences in disease status between patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer: Exploratory analysis of the randomized phase III TRICS trial.,"BACKGROUND


Second-line chemotherapy (SLC) improves survival in advanced gastric cancer (AGC). Patients receiving SLC are categorized into two disease status groups: tumour progression after first-line chemotherapy and early recurrence after adjuvant chemotherapy. Differences between these groups have not yet been clarified.
PATIENTS AND METHODS


A total of 163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n = 55) or the early relapse (ER) group (n = 108). We compared overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety. Adjusted OS and adjusted PFS were estimated using inverse probability of treatment weighting (IPTW).
RESULTS


The ER group had a lower median age than the PD group (66 vs. 72 years; P = 0.016), performance status (PS) 0 was more frequently seen in the ER group (87% vs. 71%; P = 0.012). The adjusted median OS was 13.7 months in the ER group and 13.6 months in the PD group (IPTW hazard ratio [HR]: 1.023; P = 0.854). The adjusted median PFS was 4.9 months in the ER group and 4.4 months in the PD group (IPTW HR: 0.707; P = 0.004). ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020). No significant differences were observed in the incidence of adverse events.
CONCLUSIONS


ER was associated with improved PFS and better ORR than PD, although no difference in survival was demonstrated. From the viewpoint of treatment outcome, it seems appropriate to treat patients with ER in the same way as patients with PD.
CLINICAL TRIAL REGISTRATION


UMIN 000002571.",2020,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"['advanced gastric cancer (AGC', 'patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer', '163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n\xa0=\xa055) or the early relapse (ER) group (n\xa0=\xa0108']",['Second-line chemotherapy (SLC'],"['adjusted median PFS', 'survival', 'ORR', 'performance status (PS) 0', 'adjusted median OS', 'incidence of adverse events', 'PFS and better ORR', 'overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",163.0,0.100949,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: kazuno13@hotmail.co.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Graduate School of Medicine, Kurume University, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. Electronic address: kmurotani@med.kurume-u.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056 Japan. Electronic address: fujitani@gh.opho.jp.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Inagaki', 'Affiliation': 'Department of Surgery, Inagaki Clinic, 1-2-9, Nenohanacho, Owariasahi, 488-0002 Japan. Electronic address: h.inagaki@ina-cl.com.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, 563-8510 Japan. Electronic address: akamaru@ka3.so-net.ne.jp.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 Japan. Electronic address: t-shinya@d7.dion.ne.jp.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Surgery, Shizuoka General Hospital, 4-27-1, Kitaando, Aoi-ku, Shizuoka, 420-0881 Japan. Electronic address: masakazu-takagi@i.shizuoka-pho.jp.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryugecho, Yao, 581-0069 Japan. Electronic address: shigeyuki.tamura@hosp-yao.osaka.jp.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567 Japan. Electronic address: sugimoto-na2@mc.pref.osaka.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Gastroenterology, Saiseikai Shiga Prefectural Hospital, 2-4-1, Ohashi Ritto, 520-3046 Japan. Electronic address: bssjh242@yahoo.co.jp.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, The National Hospital Organization National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan. Electronic address: tayoshik@ncc.go.jp.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center,1981, Kamoda, Kawagoe, 350-0844 Japan. Electronic address: itoru@saitama-med.ac.jp.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Comprehensive Cancer Center, Aizawa Hospital, 2-5-1, Honjo, Matsumoto, 390-0814 Japan. Electronic address: geka-dr7@ai-hosp.or.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: hasegawa.hiroko.yr@mail.hosp.go.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8397 Japan. Electronic address: smorita@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Miyashita', 'Affiliation': 'Data Center, Epidemiological & Clinical Research Information Network, 21-7, Shogoinsannocho, Sakyo-ku, Kyoto, 606-8392 Japan. Electronic address: miya@ecrin.or.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': 'Department of Surgery, Ozawa Hospital, 1-1-17, Honcho, Odawara, 250-0012 Japan. Electronic address: tuburayaa@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, 4-6-2, Sohara Higashijimacho, Kakamigahara, 504-8601 Japan. Electronic address: sakamjun@tokaihp.jp.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Kaizuka City Hospital, 3-10-20, Hori, Kaizuka, 597-0015 Japan. Electronic address: tsujinaka@hosp.kaizuka.osaka.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.027']
42,32388895,Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed.,"AIM


Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial.
METHOD


Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis.
RESULTS


From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group.
CONCLUSION


Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.",2020,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","['From 2010 to 2016, 93 participants were randomised, aged 35 to 86 years, with 1-6 lung metastases at a median of 2.7 years after colorectal cancer resection', '14 hospitals recruited patients with resectable lung metastases into a two-arm trial', 'Colorectal Cancer (PulMiCC']",['chemotherapy or local ablation'],"['Survival', 'median survival']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.290895,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Institute for Lung Diseases of Vojvodina, Thoracic Surgery Clinic, Sremska Kamenica, Serbia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tsang', 'Affiliation': 'Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shackcloth', 'Affiliation': 'Liverpool Heart And Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Batchelor', 'Affiliation': 'Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Coonar', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Division of Surgery, Royal Free London NHS Foundation Trust, UCL, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchbank', 'Affiliation': 'Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grumett', 'Affiliation': 'The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical & Interventional Trials Unit (SITU), University College London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15113']
43,32386407,Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice?,"The stepped-wedge cluster randomized trial (SW-CRT) involves the sequential transition of clusters (such as hospitals, public health units or communities) from control to intervention conditions in a randomized order. The use of the SW-CRT is growing rapidly. Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT). For this reason, the CONSORT extension for SW-CRTs requires that investigators provide a clear justification for the choice of study design. In this paper, we argue that all other things being equal, the SW-CRT is at greater risk of bias due to misspecification of the secular trends at the analysis stage. This is particularly problematic for studies randomizing a small number of heterogeneous clusters. We outline the potential conditions under which an SW-CRT might be an appropriate choice. Potentially appropriate and often overlapping justifications for conducting an SW-CRT include: (i) the SW-CRT provides a means to conduct a randomized evaluation which otherwise would not be possible; (ii) the SW-CRT facilitates cluster recruitment as it enhances the acceptability of a randomized evaluation either to cluster gatekeepers or other stakeholders; (iii) the SW-CRT is the only feasible design due to pragmatic and logistical constraints (for example the roll-out of a scare resource); and (iv) the SW-CRT has increased statistical power over other study designs (which will include situations with a limited number of clusters). As the number of arguments in favour of an SW-CRT increases, the likelihood that the benefits of using the SW-CRT, as opposed to a parallel-CRT, outweigh its risks also increases. We argue that the mere popularity and novelty of the SW-CRT should not be a factor in its adoption. In situations when a conventional parallel-CRT is feasible, it is likely to be the preferred design.",2020,Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT).,[],[],[],[],[],[],,0.0694736,Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT).,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",International journal of epidemiology,['10.1093/ije/dyaa077']
44,32391894,Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial.,"Importance


In addition to treatment efficacy, evaluation of adverse effects and quality of life assessments have become increasingly relevant in oncology.
Objective


To evaluate the association of watching Disney movies during chemotherapy with emotional and social functioning and fatigue status.
Design, Setting, and Participants


This randomized clinical trial was performed from December 2017 to December 2018 at a cancer referral center in Vienna, Austria. A consecutive sample of women with gynecologic cancers was recruited through July 2018. Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin. Exclusion criteria were inadequate knowledge of the German language or receipt of other chemotherapy regimens. Data analysis was performed from February 2019 to April 2019.
Intervention


Participants were either shown Disney movies or not during 6 cycles of chemotherapy. Before and after every cycle, they completed standardized questionnaires from the European Organisation for Research and Treatment of Cancer (EORTC).
Main Outcomes and Measures


Primary outcomes were change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue, during 6 cycles of chemotherapy.
Results


Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years). In the course of 6 cycles of chemotherapy, patients in the Disney group felt less tense and worried less than patients in the control group according to their responses to the questions about emotional functioning (mean [SD] score, 86.9 [14.3] vs 66.3 [27.2]; maximum test P = .02). Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01). Moreover, this intervention led to fewer fatigue symptoms (mean [SD] score, 85.5 [13.6] vs 66.4 [22.5]; maximum test P = .01). Perceived global health status was not associated with watching Disney movies (mean [SD] score, 75.9 [17.6] vs 61.0 [25.1]; maximum test P = .16).
Conclusions and Relevance


These findings suggest that watching Disney movies during chemotherapy may be associated with improvements in emotional functioning, social functioning, and fatigue status in patients with gynecologic cancers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03863912.",2020,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","['Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either', 'December 2017 to December 2018 at a cancer referral center in Vienna, Austria', 'women with gynecologic cancers was recruited through July 2018', 'Patients With Gynecologic Cancer', 'patients with gynecologic cancers', 'Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years']","['Viewing Disney Movies', 'carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin']","['Perceived global health status', 'Quality of Life', 'change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue', 'emotional functioning, social functioning, and fatigue status', 'fatigue symptoms', ""patients' family life and social activities"", 'social functioning questions']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.15327,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pils', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Enikoe', 'Initials': 'E', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, General Hospital of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4568']
45,32327729,Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma.,"In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.",2020,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).",[],"['placebo', 'ixazomib versus placebo', 'ixazomib']","['partial response or partial response (VGPR/PR', 'progression-free survival (PFS', '24-month PFS rate', 'median PFS', 'Median PFS', 'progression-free survival']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0931225,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Internal Medicine V and National Center for Tumor Diseases (NCT), University Clinic Heidelberg, Heidelberg, Germany. Hartmut.Goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology & Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Mikala', 'Affiliation': 'South Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford University Hospitals, NHS Foundation Trust, Oxford Myeloma Centre for Translational Research, Oxford, UK.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, IBSAL, CIC, IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Leukemia,['10.1038/s41375-020-0819-8']
46,32387453,"Clinical and molecular characteristics and treatment outcomes of advanced right-colon, left-colon and rectal cancers: data from 1180 patients in a phase III trial of panitumumab with an extended biomarker panel.","BACKGROUND


Primary tumour location (PTL) is being adopted by clinicians to guide treatment decisions in metastatic colorectal cancer (mCRC). Here we test PTL as a predictive marker for panitumumab efficacy, and examine its relationship with an extended biomarker profile. We also examine rectal tumours as a separate location.
PATIENTS AND METHODS


mCRC patients from the second-line PICCOLO trial of irinotecan versus irinotecan/panitumumab (IrPan). PTL was classified as right-PTL, left-PTL or rectal-PTL. PTL was assessed as a predictive biomarker for IrPan effect in RAS-wild-type (RAS-wt) patients (compared with irinotecan alone), then tested for independence alongside an extended biomarker profile (BRAF, epiregulin/amphiregulin (EREG/AREG) and HER3 mRNA expression).
RESULTS


PTL data were available for 1180 patients (98.5%), of whom 558 were RAS-wt. High HER3 expression was independently predictive of panitumumab overall survival improvement, but PTL and EREG/AREG were not. IrPan progression-free survival (PFS) improvement compared with irinotecan was seen in left-PTL [hazard ratio (HR) = 0.61, P = 0.002) but not right-PTL (HR = 0.98, P = 0.90) (interaction P = 0.05; RAS/BRAF-wt interaction P = 0.10), or in rectal-PTL (HR = 0.82, P = 0.20) (interaction P = 0.14 compared with left-PTL; RAS/BRAF-wt interaction P = 0.04). Patients with right-PTL and high EREG/AREG or HER3 expression, had IrPan PFS improvement (high EREG/AREG HR = 0.20, P = 0.04; high HER3 HR = 0.33, P = 0.10) compared with irinotecan. Similar effect was seen for rectal-PTL patients (high EREG/AREG HR = 0.44, P = 0.03; high HER3 HR = 0.34, P = 0.05).
CONCLUSIONS


RAS-wt patients with left-PTL are more likely to have panitumumab PFS advantage than those with right-PTL or rectal-PTL. However, an extended biomarker panel demonstrated significant heterogeneity in panitumumab PFS effect within a tumour location. AREG/EREG and HER3 mRNA expression identifies patients with right-PTL or rectal-PTL who achieve similar PFS effect with panitumumab as left-colon patients. Testing could provide a more reliable basis for clinical decision making. Further validation and development of these biomarkers is required to optimise routine patient care.
CLINICAL TRIAL REGISTRATION


ISRCTN identifier: ISRCTN93248876.",2020,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","['advanced colorectal cancer (aCRC', 'advanced right-colon, left-colon and rectal cancers', '1180 patients in a phase III trial of panitumumab with an extended biomarker panel', 'aCRC patients from the second-line PICCOLO trial of']","['irinotecan /panitumumab', 'irinotecan versus irinotecan/panitumumab', 'panitumumab', 'irinotecan']","['IrPan PFS improvement', 'High HER3 expression', 'EREG/AREG or HER3 expression, had IrPan PFS improvement']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0072460', 'cui_str': 'Proto-Oncogene Protein erbB-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C3884279', 'cui_str': 'EREG protein, human'}, {'cui': 'C3884535', 'cui_str': 'AREG protein, human'}]",558.0,0.0774107,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. Electronic address: j.seligmann@leeds.ac.uk.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Richman', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hemmings', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jacobs', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Barrett', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.476']
47,32389457,Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi.,"PURPOSE


The purpose of this study was to compare the effectiveness, safety, and experiences with side effects of self-injected and provider-administered injectable contraception between young (18-24 years) versus older (≥25 years) women.
METHODS


We conducted secondary analysis of data from a 12-month randomized controlled trial in Malawi, where a total of 731 women were randomized to receive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) administered by a provider or be trained to self-inject subcutaneous depot medroxyprogesterone acetate. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences, including adverse events. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, safety, and side effects among young women versus older women.
RESULTS


Among self-injectors, there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women. Continuation rates were lower for both age groups with provider-administered injections. In the provider-administered group, continuation rates among young women (39%) were lower than among older women (49%) (p = .047). The distribution of reasons for discontinuation did not differ significantly by age for those receiving provider injections (p = .698). However, younger self-injectors were less likely to miss the reinjection window than older self-injectors (p = .011). Age did not significantly influence pregnancy or safety.
CONCLUSIONS


With evidence of potential higher impact on continuation and no safety concerns, we recommend self-injection be added to the contraception options available to young women in low-resource settings.",2020,", there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women.","[""Young Women's Experiences With"", '731 women', 'young (18-24\xa0years) versus older (≥25\xa0years) women', 'young women versus older women']","['self-injected and provider-administered injectable contraception', 'subcutaneous depot medroxyprogesterone acetate (DMPA-SC', 'Subcutaneous Depot Medroxyprogesterone Acetate', 'medroxyprogesterone acetate']","['continuation rates', 'Continuation rates', 'distribution of reasons for discontinuation', 'adverse events', 'continuation, pregnancy, safety, and side effects', 'pregnancy or safety']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1262153', 'cui_str': 'Injectable contraception'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",731.0,0.15831,", there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women.","[{'ForeName': 'Holly M', 'Initials': 'HM', 'LastName': 'Burke', 'Affiliation': 'FHI 360, Reproductive, Maternal, Newborn, and Child Health, Durham, North Carolina. Electronic address: hburke@fhi360.org.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'FHI 360, Biostatistics, Durham, North Carolina.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'FHI 360, Reproductive, Maternal, Newborn, and Child Health, Durham, North Carolina.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'FHI 360, Biostatistics, Durham, North Carolina.'}, {'ForeName': 'Bagrey', 'Initials': 'B', 'LastName': 'Ngwira', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.03.038']
48,32402160,Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.,"BACKGROUND


The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.
METHODS


In a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
RESULTS


The intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (August 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42 to 0.79; P<0.001). Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib. Median progression-free survival was 6.8 months (95% CI, 5.7 to 8.3) and 4.3 months (95% CI, 4.0 to 5.6) in the respective groups (hazard ratio for disease progression or death, 0.59; 95% CI, 0.47 to 0.76; P<0.001). Grade 3 or 4 adverse events occurred in 56.5% of 329 patients who received at least one dose of atezolizumab-bevacizumab and in 55.1% of 156 patients who received at least one dose of sorafenib. Grade 3 or 4 hypertension occurred in 15.2% of patients in the atezolizumab-bevacizumab group; however, other high-grade toxic effects were infrequent.
CONCLUSIONS


In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.).",2020,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","['patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment', 'group and 165 patients in the sorafenib group', 'Unresectable Hepatocellular Carcinoma', '336 patients in the', 'patients with unresectable hepatocellular carcinoma']","['sorafenib', 'atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab', 'atezolizumab-bevacizumab', 'atezolizumab plus bevacizumab or sorafenib', 'bevacizumab']","['overall and progression-free survival outcomes', 'Median progression-free survival', 'Grade 3 or 4 hypertension', 'Grade 3 or 4 adverse events', 'Overall survival', 'antitumor activity and safety', 'grade toxic effects', 'overall survival and progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.465943,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ahmed O', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Daneng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Derek-Zhen', 'Initials': 'DZ', 'LastName': 'Xu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sairy', 'Initials': 'S', 'LastName': 'Hernandez', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mulla', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915745']
49,32393991,"Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures: a randomized control trial"" by Badenhorst et al.",,2020,,[],"['Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures']",[],[],"[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0559876', 'cui_str': 'Unstable fracture'}]",[],,0.0157977,,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India. dr.aditya.agg@gmail.com.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Rajnish', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Bachhal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}]",International orthopaedics,['10.1007/s00264-020-04602-0']
50,32392169,A randomised comparison of monoplane versus biplane fluoroscopy in patients undergoing percutaneous coronary intervention: the RAMBO trial.,"AIMS


Interventional cardiologists are exposed to substantial occupational ionising radiation. This study sought to investigate differences in radiation exposure in biplane versus monoplane coronary angiography and percutaneous coronary interventions (PCI).
METHODS AND RESULTS


RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions) was a prospective, randomised, two-arm, single-centre, open-label trial, enrolling a total of 430 patients undergoing coronary angiography. Patients were randomly assigned to biplane or monoplane imaging. The primary efficacy measure, the operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter, was significantly higher in the biplane as compared to the monoplane group (4 [1-13] µSv vs 2 [0-6.8] µSv, p<0.001). The dose area product was 11,955 (7,095-18,246) mGy*cm2 and 8,349 (5,851-14,159) mGy*cm2 in the biplane and the monoplane groups, respectively (p<0.001). While fluoroscopy time did not differ between the groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p<0.001).
CONCLUSIONS


Biplane imaging for coronary angiography and PCI is related to an increased radiation exposure for the interventional cardiologist as compared with monoplane imaging. Monoplane imaging should be considered for advanced radioprotection in cardiac catheterisation, with biplane imaging used for selected cases only. Visual summary. RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions: the RAMBO trial.",2020,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
",['430 patients undergoing coronary angiography'],"['biplane or monoplane imaging', 'RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions', 'biplane versus monoplane coronary angiography and percutaneous coronary interventions (PCI', 'RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions']","['amount of contrast medium', 'fluoroscopy time', 'operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0230347', 'cui_str': 'Left upper arm structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0180488', 'cui_str': 'Dosimeter'}]",430.0,0.0355147,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Leistner', 'Affiliation': 'Department of Cardiology, Charité Berlin - University Medicine, Campus Benjamin Franklin, Berlin, and DZHK (German Centre for Cardiovascular Research), partner site Berlin, Berlin, Germany.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Schlender', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Erbay', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Klotsche', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schauerte', 'Affiliation': ''}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Haghikia', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauch-Kröhnert', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sinning', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': ''}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Mochmann', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': ''}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': ''}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00217']
51,32394880,Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial.,"New dengue vaccines are needed to prevent this globally expanding vector-borne disease. The V180 vaccine candidate consists of four recombinant, soluble, dengue virus envelope glycoproteins and has been previously evaluated in two clinical trials for safety and immunogenicity in  Flavivirus -naive participants (NCT01477580 and NCT0093642). Here, we report on a randomized, placebo-controlled, double-blind study of the safety and immunogenicity of the V180 vaccine in subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301]). The study was designed to evaluate whether this recombinant subunit vaccine could boost the neutralizing antibody responses induced by dengue LATV. Twenty participants who had previously received one or two doses of dengue LATV were randomized and received a single dose of V180 nonadjuvanted ( N  = 8), V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ( N  = 8), or placebo ( N  = 4). Immunogenicity was measured using a plaque reduction neutralization test at days 1, 15, 28, and 180 after vaccination. In addition, vaccine safety (solicited and unsolicited adverse events) was assessed using a vaccination report card for 28 days following vaccination, and serious adverse events were captured from the time of informed consent through the final study visit at 6 months after vaccination. The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.",2020,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"['Adults', 'Twenty participants who had previously received one or two doses of dengue LATV', 'subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301']","['V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ', 'placebo', 'Tetravalent Recombinant Subunit Dengue Vaccine', 'recombinant subunit vaccine', 'Live Attenuated Tetravalent Dengue Vaccine', 'V180 vaccine']","['vaccine safety (solicited and unsolicited adverse events', 'tolerated and immunogenic', 'neutralizing antibody responses', 'Immunogenicity and Safety', 'Immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1513895', 'cui_str': 'National Institute of Allergy and Infectious Diseases'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0002372', 'cui_str': 'algeldrate'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",20.0,0.508172,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"[{'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Palmtama', 'Initials': 'P', 'LastName': 'Grier', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sausser', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Amy Falk', 'Initials': 'AF', 'LastName': 'Russell', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hyatt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Sachs', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Andrew Wen-Tseng', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Liman', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0042']
52,32396038,Hypertrophy of Lumbopelvic Muscles in Inactive Women: A 36-Week Pilates Study.,"BACKGROUND


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


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


Controlled laboratory study.
LEVEL OF EVIDENCE


Level 3.
METHOD


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


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


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


The benefits of Pilates in rehabilitation or training are likely elicited by neuromuscular rather than morphological adaptations. Pilates has no significant impact on muscle volume and does not alter side-to-side ratios in muscle volume (degree of asymmetry) of the lumbopelvic muscles.",2020,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","['Inactive Women', 'A total of 12 inactive, healthy women (35.7 ± 5.4 years) without previous experience in Pilates']",['supervised Pilates program'],"['volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles', 'muscle volume and reduce potential side-to-side asymmetries of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles (gluteus maximus, medius, and minimus']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0224417', 'cui_str': 'Structure of iliopsoas muscle'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}]",,0.0151886,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dorado', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'López-Gordillo', 'Affiliation': 'Department of Physical Education Department, University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Serrano-Sánchez', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A L', 'Initials': 'JAL', 'LastName': 'Calbet', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Sanchis-Moysi', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}]",Sports health,['10.1177/1941738120918381']
53,32334541,Life review therapy for holocaust survivors (LRT-HS): study protocol for a randomised controlled trial.,"BACKGROUND


The Holocaust was one of the most traumatic catastrophes in recorded human history. Survivors seeking psychotherapeutic help today, now in their seventies and older, often show symptoms of a posttraumatic stress disorder (PTSD), depression, or prolonged grief disorder. Established psychological treatments for PTSD (e.g. cognitive behaviour therapy, psychodynamic therapies) have been tested and assessed mainly with young and middle-aged adults; only very few studies examined them in old age. There is no therapy outcome study known to us for any treatment mode for Holocaust survivors. Moreover, there is a need for an age group-specific treatment of PTSD and other stress-related mental disorders. A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective. However, most studies on the efficacy of life review therapy (LRT) focus on late-life depression. There is a lack of efficacy studies evaluating the effect of LRT on PTSD symptoms in older individuals that have experienced traumatic events.
METHODS


The main goal of this study is to evaluate the effect of LRT for Holocaust survivors (LRT-HS) on symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief), compared to a supportive control group. A secondary goal is to identify the characteristics of participants that seem to especially benefit from the treatment. The proposed study is a randomised, controlled follow-up trial including Holocaust survivors with one or more trauma-related disorders. The LRT treatment consists of 20-25 sessions. Before and after the treatment phase, participants in both conditions will be assessed. Follow-up will take place 6 months after the treatment. A sample size of 80 is required (drop-out rate included).
DISCUSSION


Efficacious treatments for trauma-related disorders in older people are of high importance, also because the probability of traumatisation and loss increases with age. Because this study is conducted with this specific group of multiply traumatised people, we are convinced that the results can easily transfer to other samples.
TRIAL REGISTRATION


ISRCTN, ISRCTN12823306. Registered 31 March 2018 - Retrospectively registered (first participant 22 December 2017).",2020,A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective.,"['young and middle-aged adults', 'holocaust survivors (LRT-HS', 'Holocaust survivors with one or more trauma-related disorders', 'older individuals']","['LRT', 'life review therapy (LRT']","['symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206236', 'cui_str': 'Holocaust'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",,0.101681,A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Forstmeier', 'Affiliation': 'Developmental Psychology and Clinical Psychology over the Lifespan, Institute of Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany. simon.forstmeier@uni-siegen.de.'}, {'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'van der Hal', 'Affiliation': 'Amcha, The National Israeli Center for Psychosocial Support of Survivors of the Holocaust and the Second Generation, 23 Hillel Str., P.O. Box 2930, 91029, Jerusalem, Israel.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Amcha, The National Israeli Center for Psychosocial Support of Survivors of the Holocaust and the Second Generation, 23 Hillel Str., P.O. Box 2930, 91029, Jerusalem, Israel.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maercker', 'Affiliation': 'Psychopathology and Clinical Interventions, Department of Psychology, University of Zurich, Binzmuehlestr. 14/17, 8050, Zurich, Switzerland.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Brom', 'Affiliation': 'Herzog Hospital, Givat Shaul St, 91035, Jerusalem, Israel.'}]",BMC psychiatry,['10.1186/s12888-020-02600-5']
54,32396412,A novel CpG-methylation-based nomogram predicts survival in colorectal cancer.,"Aberrant DNA methylation is significantly associated with the prognosis of patients with colorectal cancer (CRC). Therefore, the aim of this study was to develop a CpG-methylation-based nomogram for prognostic prediction in CRC. First, 378 CRC patients with methylation data from The Cancer Genome Atlas were randomly divided into training cohort (n = 249) and test cohort (n = 129). A multistep screening strategy was performed to identify six CpG sites that were significantly associated with overall survival in the training cohort. Then, Cox regression modelling was performed to construct a prognostic signature based on the candidate CpG sites. The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05). Furthermore, we established a prognostic nomogram incorporating this signature, TNM stage, and age. The nomogram exhibited better prediction for overall survival in comparison with the three independent prognostic factors in the training cohort (C-index: 0.798 vs 0.620 to 0.737;  P  < 0.001). In the test cohort, the performance of nomogram was also superior to that of the three independent prognostic factors (C-index: 0.715 vs 0.590 to 0.665;  P  < 0.05). Meanwhile, the calibration curves for survival probability showed good agreement between prediction by nomogram and actual observation in both training and test cohorts. Together, the present study provides a novel CpG-methylation-based nomogram as a promising predictor for overall survival of CRC patients, which may help improve decision-making regarding the personalized treatments of patients with CRC.",2020,"The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05).","['patients with CRC', '378 CRC patients with methylation data from The Cancer Genome Atlas', 'colorectal cancer', 'patients with colorectal cancer (CRC']",[],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",378.0,0.037205,"The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05).","[{'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital , Tianjin, China.""}, {'ForeName': 'Danwen', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, Zhongnan Hospital of Wuhan University, Clinical Medical Research Center of Peritoneal Cancer of Wuhan, Key Laboratory of Tumor Biological Behavior of Hubei Province, Clinical Cancer Study Center of Hubei Province , Wuhan, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital , Tianjin, China.""}, {'ForeName': 'Maohui', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Gastrointestinal Surgery, Zhongnan Hospital of Wuhan University, Clinical Medical Research Center of Peritoneal Cancer of Wuhan, Key Laboratory of Tumor Biological Behavior of Hubei Province, Clinical Cancer Study Center of Hubei Province , Wuhan, China.'}, {'ForeName': 'Xiongzhi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital , Tianjin, China.""}]",Epigenetics,['10.1080/15592294.2020.1762368']
55,32397980,"Efficacy and safety of myrrh in patients with incomplete abortion: a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


Myrrh (Commiphora myrrha (Nees) Engl.) has a long history of traditional use as a herbal medicine for different purposes. In ancient traditional Persian manuscripts, it has been noted that myrrh may act as uterine stimulant and probably cause complete abortion. However, there is no evidence to verify this comment. Therefore, the current study was carried out to evaluate the efficacy and safety of Myrrh in the treatment of incomplete abortion.
MATERIALS AND METHODS


In a randomized double-blinded placebo controlled clinical trial, 80 patients with ultrasound-documented retained products of conception (RPOC) were assigned to receive capsules containing 500 mg of Myrrh oleo-gum-resin or a placebo three times a day for 2 weeks. The existence of the retained tissue and its size were evaluated by ultrasound examination at the beginning and end of the study.
RESULTS


After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001). Meanwhile, the rate of successful complete abortion was 82.9% in the intervention group and 54.3% in the placebo group (P = 0.01). The patients in both groups reported no serious drug-related adverse effects.
CONCLUSION


This study shows that Myrrh is effective and safe in the resolution of the RPOC and may be considered as an alternative option for treatment of patients with incomplete abortion. However, further studies on active compounds isolated from myrrh and their uterine stimulant effects are needed.
TRIAL REGISTRATION


This study was retrospectively registered at Iranian Registry of Clinical Trials (www.irct.ir) IRCT code: IRCT20140317017034N7.",2020,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","['patients with incomplete abortion', '80 patients with ultrasound-documented retained products of conception (RPOC']","['capsules containing 500\u2009mg of Myrrh oleo-gum-resin or a placebo', 'placebo']","['efficacy and safety of Myrrh', 'Efficacy and safety', 'rate of successful complete abortion', 'no serious drug-related adverse effects', 'mean diameter of the RPOC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000810', 'cui_str': 'Incomplete miscarriage'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0230953', 'cui_str': 'Structure of product of conception'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0233105', 'cui_str': 'Abortion complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}]",80.0,0.464431,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ajdari', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. nasadi2012@yahoo.ca.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Abolhasanzadeh', 'Affiliation': 'Department of Radiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02946-z']
56,32334622,Exploring the effects of deep brain stimulation and vision on tremor in Parkinson's disease - benefits from objective methods.,"BACKGROUND


Tremor is a cardinal symptom of Parkinson's disease (PD) that may cause severe disability. As such, objective methods to determine the exact characteristics of the tremor may improve the evaluation of therapy. This methodology study aims to validate the utility of two objective technical methods of recording Parkinsonian tremor and evaluate their ability to determine the effects of Deep Brain Stimulation (DBS) of the subthalamic nucleus and of vision.
METHODS


We studied 10 patients with idiopathic PD, who were responsive to  L -Dopa and had more than 1 year use of bilateral subthalamic nucleus stimulation. The patients did not have to display visible tremor to be included in the study. Tremor was recorded with two objective methods, a force platform and a 3 dimensional (3D) motion capture system that tracked movements in four key proximal sections of the body (knee, hip, shoulder and head). They were assessed after an overnight withdrawal of anti-PD medications with DBS ON and OFF and with eyes open and closed during unperturbed and perturbed stance with randomized calf vibration, using a randomized test order design.
RESULTS


Tremor was detected with the Unified Parkinson's Disease Rating Scale (UPDRS) in 6 of 10 patients but only distally (hands and feet) with DBS OFF. With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients. The 3D motion capture system revealed that more than one body section was usually affected by tremor and that the tremor amplitude was non-uniform, but the frequency almost identical, across sites. DBS reduced tremor amplitude non-uniformly across the body. Visual input mostly reduced tremor amplitude with DBS ON.
CONCLUSIONS


Technical recording methods offer objective and sensitive detection of tremor that provide detailed characteristics such as peak amplitude, frequency and distribution pattern, and thus, provide information that can guide the optimization of treatments. Both methods detected the effects of DBS and visual input but the 3D motion system was more versatile in that it could detail the presence and properties of tremor at individual body sections.",2020,"With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients.","['10 patients with idiopathic PD, who were responsive to  L -Dopa and had more than 1 year use of bilateral subthalamic nucleus stimulation']","['deep brain stimulation and vision', 'Deep Brain Stimulation (DBS', 'DBS ON and OFF and with eyes open and closed during unperturbed and perturbed stance with randomized calf vibration']","[""Unified Parkinson's Disease Rating Scale (UPDRS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]",10.0,0.0634744,"With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients.","[{'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Fransson', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden. Per-Anders.Fransson@med.lu.se.'}, {'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Nilsson', 'Affiliation': 'Department of Health Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Diederick C', 'Initials': 'DC', 'LastName': 'Niehorster', 'Affiliation': 'Lund University Humanities Lab, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Nyström', 'Affiliation': 'Lund University Humanities Lab, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Rehncrona', 'Affiliation': 'Department of Neurosurgery, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Tjernström', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Måns', 'Initials': 'M', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Automatic Control, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Mitesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, W6 8RF, UK.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00677-3']
57,32276179,Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study.,"PURPOSE


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


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


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


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


ClinicalTrials.gov Identifier: NCT01763671.",2020,Median overall survivals were similar (adjusted HR 1·17; p = 0·50).,"['One hundred sixty six patients were randomised', 'patients with advanced nsNSCLC treated with one or two prior lines, including one platinum-based doublet', '0·61', 'patients with nsNSCLC', 'advanced non-squamous non-small-cell lung cancer (nsNSCLC', 'advanced non-squamous non-small-cell lung cancer']","['Weekly paclitaxel plus bevacizumab', 'docetaxel', '90\xa0mg/m 2  of paclitaxel (D1, D8, D15) plus 10\xa0mg/kg of bevacizumab (D1, D15) every 28 days or docetaxel', 'paclitaxel plus bevacizumab', 'platinum-based chemotherapy', 'paclitaxel and bevacizumab or docetaxel']","['Median overall survivals', 'Grade III-IV adverse events (AEs', 'hypertension', 'neuropathy', 'Objective response rates (ORRs', 'PFS and ORR', 'adjusted hazard ratio (HR', 'progression-free survival (PFS', 'neutropenia', 'median PFS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",166.0,0.224637,Median overall survivals were similar (adjusted HR 1·17; p = 0·50).,"[{'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Univ. Lille, CHU Lille, Thoracic Oncology Dept, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 - UMR-S 1277, Canther, F-59000, Lille, France. Electronic address: alexis.cortot@chru-lille.fr.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Service de Pneumologie, CHITS Sainte Musse, Toulon, France. Electronic address: clarisse.audigier-valette@ch-toulon.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Service des Maladies Respiratoires, Centre Hospitalier Général, Le Mans, France. Electronic address: omolinier@ch-lemans.fr.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Service de Pneumologie, Institut Bergonié, Bordeaux, France. Electronic address: s.le-moulec@bordeaux.unicancer.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, Assistance Public Hôpitaux de Marseille. Multidisciplinary Oncology & Therapeutic Innovations Dpt, Marseille, France. Electronic address: fabrice.barlesi@ap-hm.fr.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': ""Service D'oncologieThoracique, Hopital Bichat Claude Bernard, Paris, France. Electronic address: gerard.zalcman@aphp.fr.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dumont', 'Affiliation': 'Centre Hospitalier, Chauny, France. Electronic address: dr.dumont@ch-chauny.fr.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Pouessel', 'Affiliation': ""Service D'Oncologie Médicale, Hôpital Saint-Louis, Paris, France. Electronic address: pouessel.damien@iuct-oncopole.fr.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Poulet', 'Affiliation': 'Service de Pneumologie, CHU - Groupe Hospitalier Sud, Amiens, France. Electronic address: poulet.claire@chu-amiens.fr.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fontaine-Delaruelle', 'Affiliation': 'Centre Hospitalier Universitaire Lyon Sud, Pierre Bénite, France. Electronic address: clara.fontaine-delaruelle@chu-lyon.fr.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hiret', 'Affiliation': ""Institut de Cancérologie de L'Ouest - René Gauducheau-Saint Herblain, France. Electronic address: sandrine.hiret@ico.unicancer.fr.""}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Dixmier', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier Régional, Orléans, France. Electronic address: adrien.dixmier@chr-orleans.fr.'}, {'ForeName': 'Patrick-Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier, Pau, France. Electronic address: aldo.renault@ch-pau.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Becht', 'Affiliation': 'Oncologie Médicale, Clinique de Clémentville, Montpellier, France. Electronic address: catherine.becht@laposte.net.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Raffy', 'Affiliation': 'Service de Pneumologie, CH Louis Pasteur, Chartres, France. Electronic address: raffy.olivier@neuf.fr.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Dayen', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier, Saint Quentin, France. Electronic address: c.dayen@ch-stquentin.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Service de Pneumologie, Hôpital Larrey, Toulouse, France. Electronic address: mazieres.j@chu-toulouse.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Service de Pneumologie, CHRU Bretonneau, Tours, France. Electronic address: e.pichon@chu-tours.fr.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France. Electronic address: alexandra.langlais@ifct.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France. Electronic address: franck.morin@ifct.fr.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France; Thoracic Oncology Unit, PTV, CHU Grenoble-Alpes CS10217, 38043, Grenoble, France. Electronic address: DMoro-Sibilot@chu-grenoble.fr.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Cancer Medecine Department, Gustave Roussy, Villejuif, France; Paris-Saclay University, Orsay, France. Electronic address: benjamin.besse@gustaveroussy.fr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.022']
58,32289471,Improving health engagement and lifestyle management for breast cancer survivors with diabetes.,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.",2020,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","['Many breast cancer survivors with type 2 diabetes', 'breast cancer survivors with type 2 diabetes', 'breast cancer survivors with diabetes', 'breast cancer survivors', 'Breast cancer survivors with type 2 diabetes']","['healthy lifestyle skills training', 'novel diabetes coping skills training (DCST) intervention', 'telephone-based DCST protocol integrates three key theory-based strategies: coping skills training', 'novel behavioral intervention', 'DCST intervention plus diabetes education']","['Symptoms, distress, diabetes self-management behaviors, and self-efficacy', 'Glycosylated hemoglobin (HbA1c']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0336858,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: rebecca.shelby@duke.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Dorfman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Arthur', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America; Division of General Internal Medicine, Duke University, Durham, NC, United States of America; Department of Population Health Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Corsino', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Erkanli', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Corbett', 'Affiliation': 'Supportive Care and Survivorship Center, Duke Cancer Institute, Durham, NC, United States of America.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Kimmick', 'Affiliation': 'Division of Medical Oncology, Duke University Medical Center, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105998']
59,32320894,Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy.,"BACKGROUND


A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy.
MATERIALS AND METHODS


A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non-small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions.
RESULTS


A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices.
CONCLUSIONS


The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.",2020,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"['98 subjects participated in the SOC group and 103 in the PVS group', 'non-small cell lung cancer']","['Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy', 'standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy', 'SOC staplers', 'vascular stapler (PVS', 'PVS with SOC staplers']","['frequency of postoperative bleeding-related interventions', 'Procedure-related adverse events', 'incidence of intraoperative hemostatic interventions', 'Rates of intraoperative hemostatic interventions']","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",98.0,0.124483,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"[{'ForeName': 'Laureano', 'Initials': 'L', 'LastName': 'Molins', 'Affiliation': 'Department of Thoracic Surgery, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanuti', 'Affiliation': 'Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Force', 'Affiliation': 'Department of Surgery, The Emory Clinic, Atlanta, Georgia, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woolley', 'Affiliation': 'Consultant Thoracic Surgeon, Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Krantz', 'Affiliation': 'Division of Thoracic Surgery, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Creedon', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Schwiers', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Singleton', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA. Electronic address: dsingl12@its.jnj.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Waggoner', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fryrear', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.023']
60,32321477,Collaborative Assessment and Management of Suicidality (CAMS) compared to enhanced treatment as usual (E-TAU) for suicidal patients in an inpatient setting: study protocol for a randomized controlled trial.,"BACKGROUND


The Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that has been shown to reduce suicidal ideation and overall symptom distress. CAMS has not been previously evaluated in a standard acute inpatient mental health care setting with only short treatment times for suicidal patients. In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable. We are also investigating depressive symptoms, general symptom relief, and the quality of the therapeutic alliance as secondary outcomes.
METHODS/DESIGN


This RCT is designed as a single-center, two-armed, parallel group observer-blinded clinical effectiveness investigation. We are recruiting and randomizing 60 participants with different diagnoses, who are admitted as inpatients because of acute suicidal thoughts or behaviors into the Clinic for Psychiatry and Psychotherapy, Ev. Hospital Bethel in Bielefeld, Germany. The duration of treatment will vary depending on patients' needs and clinical assessments ranging between 10 and 40 days. Patients are assessed four times, at admission, discharge, 1 month, and 5 months post-discharge. The primary outcome measure is the Beck Scale for Suicide Ideation. Other outcome measures are administered as assessment timepoints including severity of psychiatric symptoms, depression, reasons for living, and therapeutic relationship.
DISCUSSION


This effectiveness study is being conducted on an acute ward in a psychiatric clinic where patients have multiple problems and diagnoses. Treatment is somewhat limited, and therapists have a large caseloads. The results of this study can thus be generalizable to a typical inpatient psychiatric hospital settings.
TRIAL REGISTRATION


This clinical trial has been retrospectively registered with the German Clinical Trials Register; registration code/ DRKS-ID: DRKS00013727 (on January 12, 2018). In addition, the study was also registered with the International Clinical Trials Registry Platform of the World Health Organization (identical registration code). Registry Name: ""Evaluation von CAMS versus TAU bei suizidalen Patienten - Ein stationärer RCT"".",2020,In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable.,"['suicidal patients', '60 participants with different diagnoses, who are admitted as inpatients because of acute suicidal thoughts or behaviors into the Clinic for Psychiatry and Psychotherapy, Ev']","['CAMS', 'Collaborative Assessment and Management of Suicidality (CAMS']","['suicidal ideation and overall symptom distress', 'severity of psychiatric symptoms, depression, reasons for living, and therapeutic relationship', 'Beck Scale for Suicide Ideation']","[{'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}]",60.0,0.28712,In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable.,"[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santel', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany. Miriam.Santel@uni-bielefeld.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beblo', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neuner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Berg', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hennig-Fast', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jobes', 'Affiliation': 'Department of Psychology, The Catholic University of America, Washington, DC, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Driessen', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02589-x']
61,32305093,"Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial.","BACKGROUND


Acalabrutinib is a selective, covalent Bruton tyrosine-kinase inhibitor with activity in chronic lymphocytic leukaemia. We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia.
METHODS


ELEVATE TN is a global, phase 3, multicentre, open-label study in patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries. Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6. Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function. Patients with significant cardiovascular disease were excluded, and concomitant treatment with warfarin or equivalent vitamin K antagonists was prohibited. Patients were randomly assigned (1:1:1) centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil. Treatments were administered in 28-day cycles. To reduce infusion-related reactions, acalabrutinib was administered for one cycle before obinutuzumab administration. Oral acalabrutinib was administered (100 mg) twice a day until progressive disease or unacceptable toxic effects occurred. In the acalabrutinib-obinutuzumab group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 2 and on day 1 (1000 mg) of cycles 3-7. In the obinutuzumab-chlorambucil group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 1 and on day 1 (1000 mg) of cycles 2-6. Oral chlorambucil was given (0·5 mg/kg) on days 1 and 15 of each cycle, for six cycles. The primary endpoint was progression-free survival between the two combination-therapy groups, assessed by independent review committee. Crossover to acalabrutinib was allowed in patients who progressed on obinutuzumab-chlorambucil. Safety was assessed in all patients who received at least one dose of treatment. Enrolment for this trial is complete, and the study is registered at ClinicalTrials.gov, NCT02475681.
FINDINGS


Between Sept 14, 2015, and Feb 8, 2017, we recruited 675 patients for assessment. 140 patients did not meet eligibility criteria, and 535 patients were randomly assigned to treatment. 179 patients were assigned to receive acalabrutinib-obinutuzumab, 179 patients were assigned to receive acalabrutinib monotherapy, and 177 patients were assigned to receive obinutuzumab-chlorambucil. At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy, compared with obinutuzumab-chlorambucil (median not reached with acalabrutinib and obinutuzumab vs 22·6 months with obinutuzumab, hazard ratio [HR] 0·1; 95% CI 0·06-0·17, p<0·0001; and not reached with acalabrutinib monotherapy vs 22·6 months with obinutuzumab, 0·20; 0·13-0·3, p<0·0001). Estimated progression-free survival at 24 months was 93% with acalabrutinib-obinutuzumab (95% CI 87-96%), 87% with acalabrutinib monotherapy (81-92%), and 47% with obinutuzumab-chlorambucil (39-55%). The most common grade 3 or higher adverse event across groups was neutropenia (53 [30%] of 178 patients in the acalabrutinib-obinutuzumab group, 17 [9%] of 179 patients in the acalabrutinib group, and 70 [41%] of 169 patients in the obinutuzumab-chlorambucil group). All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients). Grade 3 or higher infections occurred in 37 (21%) patients given acalabrutinib-obinutuzumab, 25 (14%) patients given acalabrutinib monotherapy, and 14 (8%) patients given obinutuzumab-chlorambucil. Deaths occurred in eight (4%) patients given acalabrutinib-obinutuzumab, 12 (7%) patients given acalabrutinib, and 15 (9%) patients given obinutuzumab-chlorambucil.
INTERPRETATION


Acalabrutinib with or without obinutuzumab significantly improved progression-free survival over obinutuzumab-chlorambucil chemoimmunotherapy, providing a chemotherapy-free treatment option with an acceptable side-effect profile that was consistent with previous studies. These data support the use of acalabrutinib in combination with obinutuzumab or alone as a new treatment option for patients with treatment-naive symptomatic chronic lymphocytic leukaemia.
FUNDING


Acerta Pharma, a member of the AstraZeneca Group, and R35 CA198183 (to JCB).",2020,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"['Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6', '140 patients did not meet eligibility criteria, and 535 patients', '675 patients for assessment', 'patients with treatment-naive chronic lymphocytic leukaemia', 'Between Sept 14, 2015, and Feb 8, 2017', 'Patients with significant cardiovascular disease', 'patients who progressed on obinutuzumab-chlorambucil', ' and 177 patients', '179 patients', 'patients with treatment-naive symptomatic chronic lymphocytic leukaemia', 'treatment-naive chronic lymphocytic leukaemia (ELEVATE TN', 'Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function', 'chronic lymphocytic leukaemia', 'patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries']","['acalabrutinib-obinutuzumab', 'centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil', 'intravenous obinutuzumab', 'acalabrutinib monotherapy', 'Oral chlorambucil', 'warfarin or equivalent vitamin K antagonists', 'acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab', 'Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab', 'obinutuzumab-chlorambucil chemoimmunotherapy', 'obinutuzumab', 'obinutuzumab-chlorambucil']","['Estimated progression-free survival', 'median progression-free survival', 'Deaths', 'Safety', 'Grade 3 or higher infections', 'progression-free survival', 'neutropenia']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",179.0,0.186592,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Department of Hematology, Somogy County Mór Kaposi General Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Skarbnik', 'Affiliation': 'Department of Medicine, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA; Lymphoproliferative Disorders Program, Novant Health Cancer Institute, Charlotte NC, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': 'Swedish Cancer Institute, Center for Blood Disorders and Stem Cell Transplantation, Seattle, WA, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology Nashville, Nashville, TN, USA.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Division of Hematology, Hematologic Malignancies and Stem Cell Transplantation, University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Munir', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's Institute of Oncology, Leeds, UK.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Walewska', 'Affiliation': 'Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Corbett', 'Affiliation': 'Department of Medicine, Tauranga Hospital, Tauranga, New Zealand.'}, {'ForeName': 'Laura Maria', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Herishanu', 'Affiliation': 'Department of Hematology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Banerji', 'Affiliation': 'Departments of Internal Medicine, Biochemistry & Medical Genetics, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Research Institute in Oncology and Hematology, CancerCare Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Coutre', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Follows', 'Affiliation': ""Department of Haematology, Addenbrooke's Hospital NHS Trust, Cambridge, UK.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walker', 'Affiliation': 'Peninsula Health, and Peninsula Private Hospital, Frankston, Victoria, Australia; Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Karlsson', 'Affiliation': 'Department of Haematology, Oncology and Radiophysics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Hematology Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': 'Bobigny: Hématologie, CHU Avicennes, Bobigny, France.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ""Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d'Hématologie Clinique, Pierre-Bénite, France.""}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Min Hui', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA. Electronic address: john.byrd@osumc.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30262-2']
62,32329742,The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity.,"BACKGROUND


Health games provide opportunities for the treatment and prevention of childhood obesity. We developed a motion-controlled serious game for children that addresses 3 core topics of nutrition, physical activity, and stress coping. It is the first serious game that extensively targets the dietary energy density principle (DED-P) in relation to nutrition. The game is intended to provide an additional educational component for the prevention and treatment of obesity in children.
OBJECTIVE


The Kids Obesity Prevention study aimed to evaluate the newly developed game and to evaluate how well children are able to understand and apply the DED-P.
METHODS


This cluster randomized controlled trial collected data from 82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2). The dropout rate was 3.6%. The intervention group (IG) played the game within 2 weeks (2 sessions with different game modules). One part of the game involves selection of food with the lower energy density when presented with a pair of foods. This allows assessment of whether the children have understood the DED-P and whether they can apply it to unknown foods under time pressure. The control group (CG) received a brochure about the food pyramid concept and physical activity. The primary outcome was the gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire. The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
RESULTS


The knowledge score ranging from 0 to 100 increased from T0 (IG: 53 [SD 10], CG: 50 [SD 11]) to T1 (IG: 69 [SD 11], CG: 52 [SD 12]) in IG versus CG (P<.001). At T2, the knowledge score of IG remained at the same level as that of T1. Game data showed that after DED-P education, the classification under time pressure of unknown versus known food pairs according to their DED category was similar (hit rate around 70%). Overall, 95% of the children liked the game very much or much. No group changes were observed at the behavioral level.
CONCLUSIONS


The Kids Obesity Prevention program sustainably increased knowledge in the areas of nutrition and stress coping, and children were able to apply the DED-P.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02551978; https://clinicaltrials.gov/ct2/show/NCT02551978.",2020,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","['Childhood Obesity', '82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2']",['control group (CG) received a brochure about the food pyramid concept and physical activity'],"['knowledge score of IG', 'maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake', 'dropout rate', 'gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire', 'behavioral level']","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.102248,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mack', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Reiband', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Etges', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eichhorn', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schaeffeler', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Zurstiege', 'Affiliation': 'Department of Media Studies Tübingen, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Gawrilow', 'Affiliation': 'Department of School Psychology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Riyad', 'Initials': 'R', 'LastName': 'Peeraully', 'Affiliation': ""Department of Paediatric Surgery, Nottingham Children's Hospital, Nottingham, United Kingdom.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'LVR-Clinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Blumenstock', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katrin Elisabeth', 'Initials': 'KE', 'LastName': 'Giel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}]",Journal of medical Internet research,['10.2196/15725']
63,32305727,A polymorphism within the R-spondin 2 gene predicts outcome in metastatic colorectal cancer patients treated with FOLFIRI/bevacizumab: data from FIRE-3 and TRIBE trials.,"BACKGROUND


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


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


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


Genotyping of the RSPO2 rs555008 polymorphism may help to select patients who will derive the most benefit from FOLFIRI/bevacizumab dependent on (K)RAS mutational status.",2020,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","['patients with metastatic colorectal cancer (mCRC) treated with', '773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either', 'metastatic colorectal cancer patients treated with']","['FOLFIRI/bevacizumab', 'bevacizumab', 'upfront FOLFIRI and bevacizumab', 'six functional single-nucleotide polymorphisms (SNPs', 'FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group']","['overall survival', 'shorter progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",773.0,0.0944452,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: martin.berger@insel.ch.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Hematology, Oncology, and Tumor Immunology (Campus Charité Mitte), Charité Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Hanna', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Puccini', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ryuma', 'Initials': 'R', 'LastName': 'Tokunaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Battaglin', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.048']
64,32325419,"Efficacy and safety of the therapeutic cancer vaccine tecemotide (L-BLP25) in early breast cancer: Results from a prospective, randomised, neoadjuvant phase II study (ABCSG 34).","BACKGROUND


Immune-based strategies represent a promising approach in breast cancer (BC) treatment. The glycoprotein mucin-1 (MUC-1) is overexpressed in more than 90% of BC patients, and is targeted by the cancer vaccine tecemotide. We have investigated the efficacy and safety of tecemotide when added to neoadjuvant standard-of-care (SoC) treatment in early BC patients.
PATIENTS AND METHODS


A total of 400 patients with HER2-early BC were recruited into this prospective, multicentre, randomised 2-arm academic phase II trial. Patients received preoperative SoC treatment (chemotherapy or endocrine therapy) with or without tecemotide. Postmenopausal women with oestrogen receptor (ER)+++, or ER++ and Ki67 < 14%, and G1,2 tumours ('luminal A' tumours) received 6 months of letrozole. Postmenopausal patients with triple-negative, ER-/+/++ and Ki67 ≥ 14%, and with G3 tumours, as well as premenopausal patients, received four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel. Primary end-point was residual cancer burden (RCB; 0/I versus II/III) at surgery. Secondary end-points included pathological complete response (pCR), safety, and quality of life.
FINDINGS


We observed no significant difference in RCB 0/I rates between patients with (36.4%) and without (31.9%) tecemotide in the overall study population (p = 0.40) nor in endocrine and chemotherapy-treated subgroups (25.0% versus 13.3%, p = 0.17; 39.6% versus 37.8%, p = 0.75, respectively). The addition of tecemotide did not affect overall pCR rates (22.5% versus 17.4%, p = 0.23), MUC-1 expression, or tumour-infiltrating lymphocytes content. Tecemotide did not increase toxicity when compared to SoC therapy alone.
INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.",2020,"INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.","['early BC patients', 'Postmenopausal patients with triple-negative, ER-/+/++ and Ki67\xa0≥\xa014%, and with G3 tumours, as well as premenopausal patients', 'early breast cancer', 'patients receiving standard neoadjuvant therapy', '400 patients with HER2-early BC', 'Postmenopausal women with oestrogen receptor (ER)+++, or ER++ and Ki67']","['letrozole', 'preoperative SoC treatment (chemotherapy or endocrine therapy) with or without tecemotide', 'epirubicin/cyclophosphamide plus four cycles of docetaxel', 'therapeutic cancer vaccine tecemotide (L-BLP25']","['pathological complete response (pCR), safety, and quality of life', 'overall pCR rates', 'RCB 0/I rates', 'residual cancer burden (RCB', 'MUC-1 expression, or tumour-infiltrating lymphocytes\xa0content', 'RCB or pCR rates', 'toxicity', 'Efficacy and safety']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C2724205', 'cui_str': '+++'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Cancer'}, {'cui': 'C1832016', 'cui_str': 'L-BLP25'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",400.0,0.0652501,"INTERPRETATION


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.","[{'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria. Electronic address: christian.singer@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfeiler', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hubalek', 'Affiliation': 'Breast Center Schwaz, BKH Schwaz, Schwaz, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bartsch', 'Affiliation': 'Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Stöger', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal Germany, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Muy-Kheng', 'Initials': 'MK', 'LastName': 'Maria Tea', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breastcenter Carinthia, St. Veit, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sevelda', 'Affiliation': 'Karl Landsteiner Institute for Gynecologic Oncology and Senology, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breastcenter St. Anna, Lucerne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Jakesz', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tinchon', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frantal', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group (ABCSG), Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.018']
65,32180481,Analysis of the effects of mEHT on the treatment-related toxicity and quality of life of HIV-positive cervical cancer patients.,"Introduction:  HIV infection is associated with increased treatment-related toxicity and worse outcomes in locally advanced cervical cancer patients (LACC), especially in resource-constrained settings. Local control (LC) in a phase III randomized, controlled trial investigating modulated electro-hyperthermia (mEHT) on LACC patients in South Africa (ethics registration: M120477/M190295), was significantly higher in participants randomized to receive chemoradiotherapy (CRT) with mEHT compared to CRT alone (stratum: HIV status, accounting for age and stage). This analysis investigates whether mEHT adds to the toxicity profile of CRT in HIV-positive LACC participants. Methods:  Inclusion criteria: signed informed consent; International Federation of Gynecology and Obstetrics stages IIB to IIIB squamous cell carcinoma of the cervix; HIV-positive patients: CD4 count >200 cell/µL/on antiretroviral treatment for >6 months; eligible for CRT with radical intent. Recruitment: January 2014 to November 2017 (ClinicalTrials.gov: NCT03332069). Acute toxicity (evaluated using CTCAE v4 criteria) and quality of life (according to EORTC forms) in 206 participants randomized for treatment were evaluated alongside the LC results to determine safety and efficacy in HIV-positive participants. Results:  Compliance to mEHT treatment was high (97% completed ≥8 treatments) with no significant differences in CRT-related toxicity between treatment groups or between HIV-positive and -negative participants. Adverse events attributed to mEHT were minor, even in obese patients, and did not affect CRT compliance. Participants treated with mEHT reported improved fatigue, pain, emotional and cognitive functioning. Conclusion:  mEHT did not cause unexpected CRT-related toxicities and is a safe treatment modality for HIV-positive patients, with minor limitations regarding body weight, even in a low-resource setting.",2020,"Conclusion:  mEHT did not cause unexpected CRT-related toxicities and is a safe treatment modality for HIV-positive patients, with minor limitations regarding body weight, even in a low-resource setting.","['stages IIB to IIIB squamous cell carcinoma of the cervix; HIV-positive patients: CD4 count >200\u2009cell/µL/on antiretroviral treatment for >6 months; eligible for CRT with radical intent', 'locally advanced cervical cancer patients (LACC', '206 participants randomized for treatment', 'LACC patients in South Africa ', 'HIV-positive LACC participants', 'HIV-positive cervical cancer patients']","['Local control (LC', 'modulated electro-hyperthermia (mEHT', 'chemoradiotherapy (CRT) with mEHT']","['toxicity profile of CRT', 'Adverse events', 'quality of life', 'toxicity and quality of life', 'CRT-related toxicity', 'fatigue, pain, emotional and cognitive functioning', 'Acute toxicity']","[{'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}, {'cui': 'C0279671', 'cui_str': 'Squamous cell carcinoma of cervix (disorder)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",206.0,0.2739,"Conclusion:  mEHT did not cause unexpected CRT-related toxicities and is a safe treatment modality for HIV-positive patients, with minor limitations regarding body weight, even in a low-resource setting.","[{'ForeName': 'Carrie Anne', 'Initials': 'CA', 'LastName': 'Minnaar', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jeffrey Allan', 'Initials': 'JA', 'LastName': 'Kotzen', 'Affiliation': 'Department of Radiation Oncology, Wits Donald Gordon Medical Centre, Johannesburg, South Africa.'}, {'ForeName': 'Thanushree', 'Initials': 'T', 'LastName': 'Naidoo', 'Affiliation': 'Department of Clinical and Radiation Oncology, Wits Donald Gordon Medical Centre, Johannesburg, South Africa.'}, {'ForeName': 'Mariza', 'Initials': 'M', 'LastName': 'Tunmer', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mboyo-Di-Tamba', 'Initials': 'MD', 'LastName': 'Vangu', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ans', 'Initials': 'A', 'LastName': 'Baeyens', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2020.1737253']
66,32224326,"Characterisation of the effects of pulsed radio frequency treatment of the dorsal root ganglion on cerebrospinal fluid cellular and peptide constituents in patients with chronic radicular pain: A randomised, triple-blinded, controlled trial.","INTRODUCTION


Chronic radicular neuropathic pain is a major clinical problem with a life time prevalence of more than 50%. Pulsed radiofrequency (PRF) treatment is a recognised therapy. However, the pathophysiology of chronic neuropathic pain (CNP) and the mechanism of action of PRF remains ill-defined. Improving our knowledge of the mechanisms of CNP and PRF action will enhance our ability to treat patients with this common debilitating problem more effectively. This study aims to characterise the CSF cellular and peptide constituents in patients with CNP and the effect of pulsed radiofrequency (PRF) on these constituents and reported pain.
MATERIALS AND METHODS


Prospective randomised tripled-blinded control trial of patients receiving PRF treatment versus sham for radicular pain. All patients received local anaesthetic to the appropriate dermatome to confirm diagnosis. Clinical assessment using standard clinical assessment tools and examination of CSF using flow cytometry and ELISA for cellular and peptide constituents was carried out before and 3 months after treatment.
RESULTS


Ten patients were randomised to PRF (n = 5) or Sham (n = 5) treatment. PRF resulted in a significant reduction in pain score (NRS) at 3 months (6.8 to 2.6, p < .05). PRF reduced the TNF-α concentration and CD3+ count in CSF. CD4/CD8 ratio of patients with CNP was lower than historical controls (1.4 versus 3.0-4.2). The majority of CD3+ cells in the CNP patients were activated effector memory cells (80%) versus the surveillance central memory cells (85%) seen in healthy controls.
CONCLUSIONS


PRF is superior to local anaesthetic administration for the management of radicular pain and is associated with CSF constituent modulation in vivo. Patients with CNP have lymphocyte characteristics which suggest immune activation.",2020,"PRF resulted in a significant reduction in pain score (NRS) at 3 months (6.8 to 2.6, p < .05).","['patients with CNP', 'patients receiving', 'patients with chronic radicular pain']","['pulsed radiofrequency (PRF', 'Pulsed radiofrequency (PRF', 'local anaesthetic', 'pulsed radio frequency treatment of the dorsal root ganglion', 'PRF', 'PRF treatment versus sham for radicular pain']","['CD4/CD8 ratio', 'TNF-α concentration and CD3+ count in CSF', 'pain score (NRS', 'majority of CD3+ cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0882828', 'cui_str': 'Cell positive for CD3 antigen'}]",10.0,0.158391,"PRF resulted in a significant reduction in pain score (NRS) at 3 months (6.8 to 2.6, p < .05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': ""Department of Pain Medicine, St James's Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Galvin', 'Affiliation': ""Department of Pain Medicine, St James's Hospital, Dublin 8, Ireland. Electronic address: davidmoore@beaumont.ie.""}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Conroy', 'Affiliation': ""Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Basabjit', 'Initials': 'B', 'LastName': 'Das', 'Affiliation': ""Department of Pain Medicine, St James's Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Dunne', 'Affiliation': ""Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lysaght', 'Affiliation': ""Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Connail', 'Initials': 'C', 'LastName': 'McCrory', 'Affiliation': ""Department of Pain Medicine, St James's Hospital, Dublin 8, Ireland; Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.""}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2020.577219']
67,32232698,Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer.,"PURPOSE


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


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


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


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


clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.",2020,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","['two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16\xa0months after random assignment', '760 women, aged 65\xa0years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer', 'women with high-risk early breast cancer']","['tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2\xa0weeks followed by four cycles of tailored dose-dense docetaxel/2\xa0weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3', 'adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy']","['HRQoL levels', 'emotional functioning, body image, and arm and breast symptoms', 'HRQoL', 'HRQoL effects', 'health-related quality of life', 'global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects']","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",760.0,0.0933665,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Gynecology and Obstetrics, Goethe University Frankfurt/M, Frankfurt, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Medical Department, Medical University Hospital, Salzburg, Austria.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05602-9']
68,32321516,Virtual reality distraction induces hypoalgesia in patients with chronic low back pain: a randomized controlled trial.,"BACKGROUND


Attentional distraction from pain has been shown to be largely ineffective for obtaining a hypoalgesic effect in patients with chronic pain when compared to a control condition. It has been hypothesized that this may be due to the non-engaging types of distraction that have been used so far. Moreover, it is suggested that the hypoalgesic effects of distraction may be attenuated by pain-related cognitions and emotions, as they may increase the attention to pain.
METHODS


In this randomized controlled trial, patients with chronic nonspecific low back pain in the intervention group (n = 42) performed a single exercise session with nonimmersive VR games, while those in the control group (n = 42) performed the same exercises without VR games. We investigated whether VR distraction had a hypoalgesic effect during and immediately after the exercises, and whether it reduced the time spent thinking of pain during the exercises. We further explored whether pain-related fear, pain catastrophizing and baseline pain intensity moderated the effects of VR distraction.
RESULTS


VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31). Preliminary exploratory analyses showed that pain-related fear, pain catastrophizing and baseline pain intensity did not moderate the effects of VR distraction.
CONCLUSIONS


Large effect sizes of VR distraction induced hypoalgesia were observed. This suggests that nonimmersive VR games can be used when it is deemed important to reduce the pain during exercises in patients with chronic nonspecific low back pain.
TRIAL REGISTRATION


NCT02679300. This trial was registered on 10 February 2016.",2020,"RESULTS


VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31).","['patients with chronic pain', 'patients with chronic nonspecific low back pain in the intervention group (n\u2009=\u200942', 'patients with chronic low back pain', 'patients with chronic nonspecific low back pain', '10 February 2016']","['single exercise session with nonimmersive VR games, while those in the control group (n\u2009=\u200942) performed the same exercises without VR games', 'VR distraction', 'Virtual reality distraction']","['hypoalgesic effect', 'time spent thinking of pain', 'pain-related fear, pain catastrophizing and baseline pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.078121,"RESULTS


VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Matheve', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium. Thomas.Matheve@uhasselt.be.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00688-0']
69,32198104,Patient and Partner Sexual Concerns During the First Year After an Implantable Cardioverter Defibrillator: A Secondary Analysis of the P+P Randomized Clinical Trial.,"BACKGROUND


Sexual concerns and changes in sexual activity are common among patients and their intimate partners after an implantable cardioverter defibrillator (ICD).
AIMS


Our aims were to (i) describe patient and partner sexual activity and related concerns from the time of an initial ICD implant through 12-month follow-up and (ii) identify factors predictive of return to sexual activity and fears associated with sexual activity.
METHODS


This secondary descriptive analysis was conducted with data from a randomized controlled trial (2009-2015) designed to compare 2 interventions for patients (Patient-Only) and for patients and their partners (Patient+Partner) after implant of an initial ICD. The sample included 105 patients and their intimate partners who reported sexual activity during the 24 months before ICD implant.
OUTCOMES


The Sexual Concerns Inventory was used to assess sexual activity and related concerns.
RESULTS


Study participants comprised 72% male and were of mean age 65.6 ± 10.6 years; partners comprised 64% female and were of mean age 63 ± 11.6 years. Sexual activity increased after ICD: 73% of patients reported no sexual intercourse during 2 months before study enrollment, whereas only 46% reported no sexual intercourse during the 2 months before 12-month follow-up. Reductions in sexual concerns were evident 1 month after implant, with continued reductions through 12 months (patient 6.48 ± 4.03 to 5.22 ± 3.38, P = .004; partner 6.93 ± 4.01 to 5.2 ± 3.56, P < .001). Patient physical health predicted sexual activity 3 months after implant placement (P = .04); general ICD concerns (P < .001) predicted patient ICD-related sexual fears at 3 months. At 12 months, baseline general ICD concerns (P < .02) predicted sexual fears.
CLINICAL IMPLICATIONS


ICD patients and partners report low levels of sexual activity at the time of initial ICD implant, with reported increases in sexual activity over the 12-month recovery period: Sexual concerns were highest immediately after ICD implant.
STRENGTHS & LIMITATIONS


Notably, the major strengths of this study were the repeated measures and longitudinal study design; the main limitation of the study was the lack of a ""usual care"" control group.
CONCLUSION


Sexual activity at the time of an initial ICD implant is low, and sexual concerns are most prominent for both patients and partners immediately after implant placement. Baseline physical health predicts subsequent sexual activity at 3 months, while general ICD-related worry predicts sexual fears at 3 and 12 months. Streur MM, Rosman LA, Sears SF, et al. Patient and Partner Sexual Concerns During the First Year After an Implantable Cardioverter Defibrillator: A Secondary Analysis of the P+P Randomized Clinical Trial. J Sex Med 2020;17:892-902.",2020,Patient physical health predicted sexual activity 3 months after implant placement (P = .04); general ICD concerns (P < .001) predicted patient ICD-related sexual fears at 3 months.,"['105 patients and their intimate partners who reported sexual activity during the 24\xa0months before ICD implant', 'patients (Patient-Only) and for patients and their partners (Patient+Partner) after implant of an initial ICD', 'Patient and Partner Sexual Concerns', 'Study participants comprised 72% male and were of mean age 65.6\xa0±\xa010.6 years; partners comprised 64% female and were of mean age 63\xa0±\xa011.6 years', 'patients and their intimate partners after an implantable cardioverter defibrillator (ICD']",['Implantable Cardioverter Defibrillator'],"['general ICD concerns', 'patient ICD-related sexual fears', 'sexual activity', 'sexual concerns', 'Sexual activity', 'sexual activity and related concerns', 'baseline general ICD concerns', 'sexual fears', 'general ICD-related worry predicts sexual fears', 'sexual intercourse']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]",105.0,0.0233031,Patient physical health predicted sexual activity 3 months after implant placement (P = .04); general ICD concerns (P < .001) predicted patient ICD-related sexual fears at 3 months.,"[{'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Streur', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, USA. Electronic address: mstreur@uw.edu.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Rosman', 'Affiliation': 'Division of Cardiology, Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Sears', 'Affiliation': 'Department of Psychology, Department of Cardiovascular Sciences, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Elaine E', 'Initials': 'EE', 'LastName': 'Steinke', 'Affiliation': 'School of Nursing, College of Health Professions, Wichita State University, Wichita, KS, USA.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, USA. Electronic address: cindyd@uw.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.01.028']
70,31695136,"Maternal low molecular weight heparin versus sildenafil citrate for fetal growth restriction: a randomized, parallel groups, open-label clinical trial.","OBJECTIVES


To compare the effect of sildenafil citrate (SC) and low molecular weight heparin (LMWH) on neonatal birth weight (BW) and the fetoplacental blood flow in pregnancies with FGR.
STUDY DESIGN


A parallel groups, randomized clinical trial was conducted at a university hospital, between June 2017 and September 2018, involving 100 pregnant women with placental mediated FGR between 28 and 35 weeks of gestation who were randomly assigned to receive either SC or LMWH started at FGR diagnosis till delivery.
RESULTS


The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
CONCLUSION


The neonatal BW, time from randomization to delivery, and fetoplacental blood flow indices were significantly better with LMWH use compared with SC.",2020,"The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
","['fetal growth restriction', 'university hospital, between June 2017 and September 2018, involving 100 pregnant women with placental mediated FGR between 28 and 35 weeks of gestation', 'pregnancies with FGR']","['sildenafil citrate (SC) and low molecular weight heparin (LMWH', 'sildenafil citrate', 'SC or LMWH']","['neonatal BW', 'neonatal birth weight (BW', 'Ut A PI, UA PI, and MCA PI', 'neonatal BW, time from randomization to delivery, and fetoplacental blood flow indices']","[{'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",100.0,0.0844184,"The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rasheedy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. radwaebed@yahoo.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Bishry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tarek', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0544-1']
71,31403536,Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis.,"BACKGROUND


Although the use of 2-octylcyanoacrylate (OCA) in cutaneous surgery offers increased efficiency, there is scant data comparing scar outcomes achieved with OCA versus 5-0 fast-absorbing gut suture (FG).
OBJECTIVE


To compare scar cosmesis achieved with OCA versus FG for surgical wound closure.
MATERIALS AND METHODS


A total of 44 patients with postoperative defects of at least 3 cm were included. Half of each wound was randomized to receive closure with either OCA or FG. At 3 months, patients and 2 blinded observers evaluated each scar using the Patient and Observer Scar Assessment Scale (POSAS).
RESULTS


The total observer POSAS score (mean [SD]) for the side repaired with OCA (12.3 [4.72]) and the side that received FG (11.6 [4.36]) did not differ significantly (p = .40). There was no significant difference in the total patient POSAS scores between closure with OCA (14.9 [8.67]) and FG (14.6 [8.90]) (p = .70). Based on observer POSAS scores, scar pigmentation was significantly worse on the scar half repaired with OCA (1.98 [0.91]) compared with FG (1.79 [0.80]) (p = .05).
CONCLUSION


With the exception of inferior scar pigmentation with OCA, there was no statistically significant difference in wound cosmesis after linear wound closure with OCA versus FG.",2020,There was no significant difference in the total patient POSAS scores between closure with OCA (14.9 [8.67]) and FG (14.6 [8.90]),['44 patients with postoperative defects of at least 3 cm were included'],"['OCA versus FG', '2-octylcyanoacrylate (OCA', 'OCA', 'Comparisonof 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut', 'OCA or FG']","['total patient POSAS scores', 'Observer Scar Assessment Scale (POSAS', 'observer POSAS scores, scar pigmentation', 'scar cosmesis', 'total observer POSAS score', 'wound cosmesis', 'Wound Cosmesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0391770', 'cui_str': '2-propenoic acid, 2-cyano-, octyl ester'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",44.0,0.0371168,There was no significant difference in the total patient POSAS scores between closure with OCA (14.9 [8.67]) and FG (14.6 [8.90]),"[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Beroukhim', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine at University of Southern California, Los Angeles, California.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002076']
72,31013539,Early Premature Infant Oral Motor Intervention Improved Oral Feeding and Prognosis by Promoting Neurodevelopment.,"OBJECTIVE


This study aimed to explore the clinical significance of early premature infant oral motor intervention (PIOMI) in the prognosis of premature infants.
STUDY DESIGN


Infants were randomly divided into an intervention group ( n  = 78) and a control group ( n  = 73). PIOMI was given to the intervention group 15 to 30 minutes before feeding once a day for 14 days. The whole procedure lasted 15 minutes, including oral stimulation and nonnutritive sucking. Oral feeding ability and neuromotor development were evaluated using the Preterm Infant Oral Feeding Readiness Assessment (PIOFRA) scale and Infant Neurological International Battery (Infanib) scale.
RESULTS


The PIOFRA score was higher in the intervention group and increased with time, showing a group-time interaction effect. The intervention group exhibited a higher feeding efficiency, a shorter transition time from assisted oral feeding to independent oral feeding, and lower body weight at achievement of independent oral feeding. The percentages of infants with a normal score on the Infanib scale were higher in the intervention group at 3 and 6 months of age, and an abnormal ratio was lower in the intervention group at 6 months ( p  < 0.01).
CONCLUSION


PIOMI promoted neuromotor coordination by improving neurodevelopment, thereby improving the oral feeding ability and prognosis of preterm infants.",2020,"Oral feeding ability and neuromotor development were evaluated using the Preterm Infant Oral Feeding Readiness Assessment (PIOFRA) scale and Infant Neurological International Battery (Infanib) scale.
","['early premature infant', 'preterm infants', 'premature infants', 'Infants']",['oral motor intervention (PIOMI'],"['Preterm Infant Oral Feeding Readiness Assessment (PIOFRA) scale and Infant Neurological International Battery (Infanib) scale', 'PIOFRA score', 'higher feeding efficiency', 'normal score on the Infanib scale', 'abnormal ratio']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332199', 'cui_str': 'Abnormal ratio (qualifier value)'}]",,0.0215062,"Oral feeding ability and neuromotor development were evaluated using the Preterm Infant Oral Feeding Readiness Assessment (PIOFRA) scale and Infant Neurological International Battery (Infanib) scale.
","[{'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': ""Department of Pediatrics, Liaocheng People's Hospital, Liaocheng, Shandong, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Liaocheng People's Hospital, Liaocheng, Shandong, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Liaocheng People's Hospital, Liaocheng, Shandong, China.""}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, Liaocheng People's Hospital, Liaocheng, Shandong, China.""}, {'ForeName': 'Qiao-Zhi', 'Initials': 'QZ', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, Liaocheng People's Hospital, Liaocheng, Shandong, China.""}]",American journal of perinatology,['10.1055/s-0039-1685448']
73,32338611,Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial.,"AIMS


We aimed to examine the impact of three different radiation protection devices in a real-world setting of radial artery catheterisation.
METHODS AND RESULTS


In an all-comer randomised trial, consecutive coronary radial diagnostic and intervention procedures were assigned in a 1:1:1 ratio to shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40 cm, 0.5 mm Pb drape placed across the waist of the patient (shield+curtain+drape group). A total of 614 radial procedures were randomised (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape). There were no differences among the groups in patient or procedural characteristics. The primary endpoint (relative exposure ratio between the operators' exposure in μSv and the patient's exposure, dose area product in cGy·cm2) was significantly lower in the shield+curtain+drape group for both the first operator (20% reduction vs shield, 16% vs shield+curtain, p=0.025) and the assistant (39% reduction vs shield, 25% vs shield+curtain, p=0.009).
CONCLUSIONS


The use of an additional drape reduced the radiation exposure of both the first operator and the second operator during routine radial procedures; a shield-attached curtain alone was only partially effective. ClinicalTrials.gov identifier: NCT03634657 Visual summary. X-ray protection devices and their effects on radiation exposure.",2020,The use of an additional drape reduced radiation exposure of both the first and second operator during routine radial procedures; a shield-attached curtain alone was only partially effective.,"['radial interventiOn', 'A total of 614 radial procedures were randomized (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape']","['radiation protection devices', 'additional x-ray PRotection dEviceS', 'shield+curtain+drape', 'shield-only protection (shield group), shield and overlapping 0.5mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40cm, 0.5mm Pb drape placed across the waist of the patient (shield+curtain+drape group']","[""primary endpoint (relative exposure ratio between operator's exposure in μSv and patient exposure, dose area product in cGy·cm2""]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0183251', 'cui_str': 'Shield'}]","[{'cui': 'C0034533', 'cui_str': 'Protection, Radiation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0556652', 'cui_str': 'mm Pb'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",614.0,0.112666,The use of an additional drape reduced radiation exposure of both the first and second operator during routine radial procedures; a shield-attached curtain alone was only partially effective.,"[{'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz and DZHK Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Brandt', 'Affiliation': ''}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Merz', 'Affiliation': ''}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Knorr', 'Affiliation': ''}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahoopai', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Geyer', 'Affiliation': ''}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Krompiec', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00945']
74,31625954,"Efficacy, Patient-Reported Outcomes, and Safety for Millennial Subjects Treated With OnabotulinumtoxinA for Moderate to Severe Horizontal Forehead Lines.","BACKGROUND


Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market.
OBJECTIVE


To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies.
METHODS


Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo. All findings were pooled by the age group.
RESULTS


Millennials composed 15% of subjects (176/1,178). Day 30 responder rates of at least 1-grade Facial Wrinkle Scale improvement in FHL severity for millennials versus subjects aged 35 years and older were 100% versus 97.8% at maximum eyebrow elevation and 78.4% versus 83.5% at rest, respectively. Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180. Similar trends were observed for achieving none/mild severity. Both age groups reported high satisfaction rates and improved psychological impacts with onabotulinumtoxinA treatment. No new safety signals were detected.
CONCLUSION


OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.",2020,Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180.,"['Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market', 'subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies', ""Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or""]","['placebo', 'onabotulinumtoxinA', 'OnabotulinumtoxinA']","['Responder rates', 'FHL severity', 'FHL severity, high satisfaction, and improved psychological impacts']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0307912,Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180.,"[{'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Palm', 'Affiliation': 'Art of Skin MD, Solana Beach, California.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Few', 'Affiliation': 'The Few Institute for Aesthetic Plastic Surgery, Chicago, Illinois.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'PHI Clinic, London, United Kingdom.'}, {'ForeName': 'Marva', 'Initials': 'M', 'LastName': 'Safa', 'Affiliation': 'La Jouvence, Neuchâtel, Switzerland.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Drinkwater', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002216']
75,31634258,"Using a Multimedia Tool for Informed Consent in Mohs Surgery: A Randomized Trial Measuring Effects on Patient Anxiety, Knowledge, and Satisfaction.","BACKGROUND


Multimedia educational materials have been found to improve aspects of informed consent, although data in the context of Mohs micrographic surgery (MMS) is limited.
OBJECTIVE


To assess whether a preoperative educational video decreases anxiety, increases comprehension, and improves overall satisfaction for patients undergoing same-day office consultation and MMS.
MATERIALS AND METHODS


This single-center randomized controlled trial included patients above the age of 18 years undergoing MMS for skin cancer between October 2015 and December 2015. Patients were randomized to view a short preoperative video on MMS in addition to traditional informed consent versus informed consent without video viewing. Questionnaires were used to assess preoperative anxiety, knowledge, and satisfaction.
RESULTS


From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups. Subjects receiving the intervention were able to more accurately recognize risks of MMS (88% vs 69% of controls, p < .001) and had improved subject-reported confidence in understanding procedural risks and benefits (89% vs 71% of controls, p = .049). Composite comprehension scores were similar between groups (p = .131).
CONCLUSION


A preoperative MMS educational video increased recognition of procedural risks, but did not improve patient anxiety or satisfaction.",2020,"From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups.","['Mohs Surgery', 'patients undergoing same-day office consultation and MMS', 'patients above the age of 18 years undergoing MMS for skin cancer between October 2015 and December 2015']","['short preoperative video on MMS in addition to traditional informed consent versus informed consent without video viewing', 'preoperative educational video']","['recognize risks of MMS', 'Patient Anxiety, Knowledge, and Satisfaction', 'Composite comprehension scores', 'patient anxiety or satisfaction', 'anxiety', 'preoperative anxiety, knowledge, and satisfaction', 'overall satisfaction']","[{'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0549411,"From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups.","[{'ForeName': 'Macey', 'Initials': 'M', 'LastName': 'Delcambre', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Haynes', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Hajar', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Spring', 'Initials': 'S', 'LastName': 'Golden', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bar', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Latour', 'Affiliation': 'Knight Cancer Institute Biostatistics Shared Resource, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Leitenberger', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002213']
76,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


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


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


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


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
77,31652220,"Blinded, Randomized, Controlled Trial Evaluating the Effects of Light-Emitting Diode Photomodulation on Lower Extremity Wounds Left to Heal by Secondary Intention.","BACKGROUND


Light-emitting diode (LED) has been used for wound healing because of its stimulatory effects on fibroblast proliferation, matrix synthesis, angiogenesis, and downmodulation of inflammatory reactions.
OBJECTIVE


The aim of the authors' study was to investigate the effects of red LED (wavelength 633 nm) photomodulation on lower extremity surgical defects left to heal by secondary intention.
MATERIALS AND METHODS


Fourteen subjects with surgical defects of the lower leg were irradiated with a 633 ± 3-nm light source for 20 minutes (105 mW/cm, 126 J/cm) at 4 weekly sessions.
RESULTS


The number of days required for wounds to heal was greater in the treatment group (63.2 ± 12.2 days) than in the control group (48.67 ± 11.1 days), although this difference was not statistically significant (p = .07). The percentage of the original wound remaining was not statistically different between treatment and control groups between Weeks 1 and 2 (p = .71) and Weeks 3 and 4 (p = .56). It was significant between Weeks 2 and 3 (p = .01).
CONCLUSION


This study revealed that red LED photomodulation at a wavelength of 633 nm did not result in clinical improvement in wound healing of surgical defects on the lower extremities.",2020,The percentage of the original wound remaining was not statistically different between treatment and control groups between Weeks 1 and 2 (p = .71) and Weeks 3 and 4 (p = .56).,"['Fourteen subjects with surgical defects of the lower leg were irradiated with a 633 ±', 'Lower Extremity Wounds Left to Heal by Secondary Intention']","['red LED (wavelength 633 nm) photomodulation', '3-nm light source', 'Light-Emitting Diode Photomodulation', 'Light-emitting diode (LED']","['number of days required for wounds to heal', 'percentage of the original wound remaining']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]",14.0,0.125328,The percentage of the original wound remaining was not statistically different between treatment and control groups between Weeks 1 and 2 (p = .71) and Weeks 3 and 4 (p = .56).,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Perper', 'Affiliation': '*All authors are affiliated with the Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, Miami, Florida.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Eber', 'Affiliation': ''}, {'ForeName': 'Scott F', 'Initials': 'SF', 'LastName': 'Lindsey', 'Affiliation': ''}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Nouri', 'Affiliation': 'All authors are affiliated with the Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, Miami, Florida.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002195']
78,31912799,Relation of cetuximab-induced skin toxicity and early tumor shrinkage in metastatic colorectal cancer patients: results of the randomized phase 3 trial FIRE-3 (AIO KRK0306).,"BACKGROUND


Cetuximab-induced skin toxicity (Cet-ST) is positively associated with outcome in metastatic colorectal cancer (mCRC). Besides its predictive relevance for targeted therapy, we investigated its prognostic impact with early tumor shrinkage (ETS) ≥20%, another on-treatment surrogate for clinical outcome in FIRE-3.
PATIENTS AND METHODS


FIRE-3 evaluated first-line FOLFIRI (folinic acid, fluorouracil and irinotecan) plus cetuximab (FOLFIRI/Cet) versus FOLFIRI plus bevacizumab (FOLFIRI/Bev) in mCRC patients with RAS-WT tumors (i.e. wild-type in KRAS and NRAS exons 2-4). Retrospective data on Cet-ST that occurred during cycles 1-3 of treatment were correlated with efficacy endpoints, including ETS. To control for guarantee-time bias, only patients who had completed three or more treatment cycles were considered.
RESULTS


Of 199 patients treated with FOLFIRI/Cet, 181 (91.0%) completed three or more treatment cycles. A significant survival benefit of FOLFIRI/Cet over FOLFIRI/Bev was only evident in patients developing Cet-ST grade 2-3 [41.0 versus 26.6 months; hazard ratio (HR) = 0.73; 95% confidence interval (CI): 0.61-0.87; P < 0.001] compared with Cet-ST grade 0-1 (HR = 0.90; 95% CI: 0.67-1.20; P = 0.48). Regarding prognosis, Cet-ST grade 2-3 (n = 75; 41.4%), compared with Cet-ST grade 0-1 (n = 106; 58.6%), was associated with prolonged overall survival (OS; HR = 0.62; 95% CI: 0.42-0.91; P = 0.01). In multivariate analysis, both Cet-ST (HR = 0.66; 95% CI: 0.50-0.87; P = 0.003) and ETS (HR = 0.55; 95% CI: 0.41-0.74; P < 0.0001) were independently prognostic for OS. Absence of both Cet-ST grade ≥2 and ETS identified a subgroup of patients with very poor prognosis (median OS 15.1 months).
CONCLUSIONS


In FIRE-3, the addition of cetuximab to FOLFIRI was associated with superior OS compared with FOLFIRI/Bev only in patients developing Cet-ST grade ≥2. Regarding prognostic relevance, both Cet-ST and ETS were independent and early predictors of survival. The present analysis supports that a combined evaluation of on-treatment parameters such as Cet-ST and ETS may help to guide treatment of mCRC.",2020,"In multivariate analysis, both Cet-ST (HR = 0.66; 95% CI: 0.50-0.87; P = 0.003) and ETS (HR = 0.55; 95% CI: 0.41-0.74; P < 0.0001) were independently prognostic for OS.","['metastatic colorectal cancer patients', 'mCRC patients with RAS-WT tumors (i.e. wild-type in KRAS and NRAS exons 2-4', 'metastatic colorectal cancer (mCRC']","['line FOLFIRI (folinic acid, fluorouracil and irinotecan) plus cetuximab (FOLFIRI/Cet) versus FOLFIRI plus bevacizumab (FOLFIRI/Bev', 'Cetuximab-induced skin toxicity (Cet-ST', 'cetuximab-induced skin toxicity']","['survival benefit of FOLFIRI/Cet over FOLFIRI/Bev', 'prolonged overall survival']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",199.0,0.0424918,"In multivariate analysis, both Cet-ST (HR = 0.66; 95% CI: 0.50-0.87; P = 0.003) and ETS (HR = 0.55; 95% CI: 0.41-0.74; P < 0.0001) were independently prognostic for OS.","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany; Comprehensive Cancer Center Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany. Electronic address: julian.holch@med.uni-muenchen.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Hematology, Oncology and Tumor Immunology (CCM), Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Praxis für Onkologie/Haematologie, Gesundheitszentrum St. Marien GmbH, Amberg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Onkologie Ravensburg, Ravensburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Department of Medicine IV, Klinikum Bayreuth GmbH, Bayreuth, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Hämato-onkologische Tagesklinik, Landshut, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Heintges', 'Affiliation': 'Department of Medicine II, Lukaskrankenhaus, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kahl', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Magdeburg gGmbH, Magdeburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Internal Medicine I, Klinikum Weiden, Weiden, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I & CCC, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'University Medical Center Mainz, I. Department of Internal Medicine, Mainz, Germany.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Medical Department, Division of Hematology, Oncology and Tumor Immunology (CCM), Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michl', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany; Comprehensive Cancer Center Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany; Comprehensive Cancer Center Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.001']
79,32046537,Cardiovascular reactions for whole-body thermal therapy with a hot pack and Waon therapy.,"Background:  Waon therapy (WT) is the predominant thermal therapy for chronic heart failure in Japan, involving use of a far-infrared dry sauna. As sauna therapy requires certain equipment not readily available in hospitals, we tested the use of whole-body hot pack thermal therapy (HPTT). We compared the magnitude of skin vasodilation post-HPTT with that post-WT. Methods:  We recruited 19 healthy men (age [mean ± S.D.]: 26.8 ± 4.6 years) and employed a simple randomized crossover design. The HPTT required subjects to remain in a supine position on a bed for at least 10 min. Hot packs were then applied on the back, lower abdomen, and popliteal regions for 15 min (warming phase). Participants continued bed rest for 30 min (heat-retention phase) after removal of the hot pack. WT was performed as previously described. Blood pressure (BP), heart rate (HR), tympanic temperature (TT), and peak and average flow velocity of the right radial artery (PFV and AFV, respectively) and right brachial artery (BA) diameter were measured during HPTT and WT. Results:  HR, TT, PFV, and AFV persistently and significantly increased during warming and heat-retention phases of HPTT. In WT, HR and TT significantly increased during warming but decreased and plateaued during heat-retention. BP did not change significantly after either therapy; however, BA was dilated equally in both (HPTT: 3.70 ± 0.57 ⇒ 4.05 ± 0.59 mm,  p  = .001; WT: 3.63 ± 0.63 ⇒ 3.93 ± 0.61 mm,  p  < .001). Conclusion:  HPTT may be equivalent to WT with respect to vasodilation response of the skin.",2020,"Results:  HR, TT, PFV, and AFV persistently and significantly increased during warming and heat-retention phases of HPTT.","['19 healthy men (age [mean\u2009±\u2009S.D.]: 26.8\u2009±\u20094.6\u2009years', 'chronic heart failure in Japan']",[':  Waon therapy (WT'],"['Blood pressure (BP), heart rate (HR), tympanic temperature (TT), and peak and average flow velocity of the right radial artery (PFV and AFV, respectively) and right brachial artery (BA) diameter', 'Results:  HR, TT, PFV, and AFV persistently and significantly increased during warming and heat-retention phases of HPTT', 'BA', 'Cardiovascular reactions', 'BP']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0226438', 'cui_str': 'Structure of right radial artery'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",19.0,0.0388981,"Results:  HR, TT, PFV, and AFV persistently and significantly increased during warming and heat-retention phases of HPTT.","[{'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kominami', 'Affiliation': 'Cardiac Rehabilitation Center, Sapporo Ryokuai Hospital, Sapporo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Noda', 'Affiliation': 'Department of Rehabilitation, National Hospital Organization Hakodate Hospital, Hakodate, Japan.'}, {'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Graduate School of Rehabilitation Sciences, Health Sciences University of Hokkaido, Tobetsu, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Izumi', 'Affiliation': 'Graduate School of Rehabilitation Sciences, Health Sciences University of Hokkaido, Tobetsu, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Clinical Research, National Hospital Organization Hakodate Hospital, Hakodate, Japan.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2020.1723719']
80,32333208,Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine.,"Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p < 0.001). MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care. Clinicaltrials.gov registration number: NCT02338024.",2020,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"['Adult participants from nine urban clinics in three regions of Ukraine', 'HIV-Positive Patients in Ukraine']","['nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive', 'MARTAS or standard of care (SOC', 'Linkage-to-Care Intervention']","['intervention efficacy', 'linkage-to-care (defined as registration at an HIV clinic']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.271332,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Neduzhko', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine. neduzhko@uiphp.org.ua.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Postnov', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Yuliia', 'Initials': 'Y', 'LastName': 'Sereda', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Roksolana', 'Initials': 'R', 'LastName': 'Kulchynska', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Kiev, Ukraine.'}, {'ForeName': 'Trista', 'Initials': 'T', 'LastName': 'Bingham', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Myers', 'Affiliation': 'Prevention Research Center, University of California, San Francisco, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Flanigan', 'Affiliation': 'Alpert Medical School, Brown University, Providence, USA.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}]",AIDS and behavior,['10.1007/s10461-020-02873-7']
81,32270927,Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study.,"OBJECTIVE


In contrast to intentionally restricting energy intake, restricting the eating window may be an option for treating obesity. By comparing time-restricted eating (TRE) with an unrestricted (non-TRE) control, it was hypothesized that TRE facilitates weight loss, alters body composition, and improves metabolic measures.
METHODS


Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2  ) with a prolonged eating window (15.4 [0.9] hours) were randomized to TRE (n = 11: 8-hour window, unrestricted eating within window) versus non-TRE (n = 9: unrestricted eating) for 12 weeks. Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed) were measured during the pre- and end-intervention periods.
RESULTS


The TRE group significantly reduced the eating window (end-intervention window: 9.9 [2.0] hours) compared with the non-TRE group (end-intervention window: 15.1 [1.1] hours) (P < 0.01). Compared with non-TRE, TRE decreased the number of eating occasions, weight, lean mass, and visceral fat (all P ≤ 0.05). Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05). Physical activity and metabolic measures remained unchanged.
CONCLUSIONS


In the setting of a randomized trial, TRE presents a simplified view of food intake that reduces weight.",2020,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","['Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2  ) with a prolonged eating window (15.4 [0.9] hours', 'Humans with Overweight']","['TRE', 'TRE (n\u2009=\u200911: 8-hour window, unrestricted eating within window) versus non-TRE']","['reduced weight', 'weight loss, alters body composition, and improves metabolic measures', 'visceral fat', 'number of eating occasions, weight, lean mass, and visceral fat', 'number of eating occasions', 'fat mass', 'Body Composition and Metabolic Measures', 'Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed', 'lean mass', 'eating window', 'Physical activity and metabolic measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",17.0,0.0340305,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Chow', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Alvear', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Fleischer', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Honoree', 'Initials': 'H', 'LastName': 'Thor', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Dietsche', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Esch', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Malaeb', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tasma', 'Initials': 'T', 'LastName': 'Harindhanavudhi', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Mashek', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22756']
82,32330117,Randomized Trial of Radial Hemostasis Using Focused vs Balloon Compression Devices.,"BACKGROUND


Radial artery hemostasis devices differ in compression mechanisms, which may influence time to hemostasis and hand perfusion.
METHODS


Subjects (n = 52) undergoing transradial diagnostic coronary catheterization or percutaneous coronary intervention (PCI) were randomized 1:1 to either focused compression (VasoStat; Forge Medical) or balloon compression device (TR Band; Terumo Medical) for radial artery hemostasis. Time to complete hemostasis enabling device removal was measured in each subject. Hand perfusion was quantitated using the perfusion index (PI) with oximetry (1) before; (2) during device use; (3) during device use with ulnar artery compression; and (4) following device removal.
RESULTS


Focused compression resulted in a significantly shorter time to complete hemostasis vs balloon compression (208 min [IQR, 115-320 min] vs 242 min [IQR, 120-439 min], respectively; P=.04). This difference was greatest among the subset undergoing PCI, where the VasoStat resulted in a 43-minute reduction until complete hemostasis (P=.04). Baseline PI was similar between the focused and balloon compression groups (4.9 vs 3.9, respectively; P=.09). Focused compression resulted in a similar reduction in median PI from baseline to during device use compared with balloon compression (-27% vs -18%, respectively; P=.26). Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02). No radial artery occlusion occurred, and rates of device manipulation and access-site bleeds were low in both groups.
CONCLUSION


Complete hemostasis was achieved earlier with the VasoStat focused compression device compared with the TR Band balloon compression device. Both devices transiently reduced hand perfusion, particularly during ulnar compression, which increased from baseline following device removal. Larger trials comparing these radial hemostasis devices and outcomes are warranted.",2020,"Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02).",['Subjects (n = 52) undergoing'],"['focused compression (VasoStat; Forge Medical) or balloon compression device (TR Band; Terumo Medical', 'Radial Hemostasis Using Focused vs Balloon Compression Devices', 'transradial diagnostic coronary catheterization or percutaneous coronary intervention (PCI']","['radial artery occlusion', 'shorter time to complete hemostasis vs balloon compression', 'rates of device manipulation and access-site bleeds', 'Baseline PI', 'median PI']",[],"[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",52.0,0.528294,"Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02).","[{'ForeName': 'Jordan G', 'Initials': 'JG', 'LastName': 'Safirstein', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, 100 Madison Ave, Morristown, NJ 07960 USA. jsaf237@yahoo.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Elfandi', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Reid', 'Affiliation': ''}, {'ForeName': 'Timothy W I', 'Initials': 'TWI', 'LastName': 'Clark', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
83,32146521,Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.
METHODS


This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
RESULTS


Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.
CONCLUSIONS


Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.",2020,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","['women with advanced prolapse versus stage II prolapse', 'women with advanced prolapse (stage III-IV) and stress urinary incontinence', 'women with advanced vaginal prolapse', 'women with advanced pelvic organ prolapse and stress urinary incontinence', 'women with advanced prolapse', 'Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse']","['ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care', 'uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF', 'native tissue transvaginal apical approaches']","['Serious adverse events', 'individual success components', 'Surgical success, symptom severity, and overall serious adverse events', 'Prolapse symptom severity scores', 'individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",374.0,0.18451,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","[{'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Wai', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-020-04271-y']
84,31912801,Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials.,"BACKGROUND


The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes.
PATIENTS AND METHODS


A total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma concentration-time curve (AUC) for FTD and TPI. We conducted a post hoc analysis using the entire RECOURSE population to determine the correlations between CIN and clinical outcome. We then carried out a similar analysis on the J003 trial to validate the results.
RESULTS


In the RECOURSE subset, patients in the high FTD AUC group had a significantly increased CIN risk. Analyses of the entire population demonstrated that FTD/TPI-treated patients with CIN of any grade in cycles 1 and 2 had significantly longer median overall survival (OS) and progression-free survival (PFS) than patients who did not develop CIN and patients in the placebo group. Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN. Similar results were obtained in the J003 cohort.
CONCLUSIONS


In RECOURSE, patients with higher FTD drug exposure had an increased CIN risk. FTD/TPI-treated patients who developed CIN had improved OS and PFS versus those in the placebo group and those who did not develop CIN. Similar findings were reported in the J003 cohort, thus validating the RECOURSE results. The occurrence of CIN may be a useful predictor of treatment outcomes for FTD/TPI-treated patients. CLINICALTRIALS.
GOV IDENTIFIER


NCT01607957 (RECOURSE).
JAPAN PHARMACEUTICAL INFORMATION CENTER NUMBER


JapicCTI-090880 (J003).",2020,Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN.,"['A total of 210 patients from RECOURSE were enrolled in this substudy', 'patients with refractory metastatic colorectal cancer', 'metastatic colorectal cancer patients treated with']","['placebo', 'trifluridine/tipiracil', 'trifluridine (FTD)/tipiracil (TPI) versus placebo']","['CIN risk', 'OS and PFS', 'Neutropenia and survival outcomes', 'survival', 'median overall survival (OS) and progression-free survival (PFS', 'plasma concentration-time curve (AUC) for FTD and TPI']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",210.0,0.256832,Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: tyoshino@east.ncc.go.jp.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Division of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': 'Oncology Department, University Hospital 12 de Octubre, IIS imas12, UCM, CNIO, CIBERONC, Madrid, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cancer Chemotherapy, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""University Hospital Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Department of Oncology, IRCCS AOU San Martino IST, Genoa, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Division of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Department of Oncology, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Clinical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Department of Gastrointestinal Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tran', 'Affiliation': 'Department of Medical Oncology, The Royal Melbourne Hospital, Victoria, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': 'Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tanase', 'Affiliation': 'Department of Data Science, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Clinical Development, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Makris', 'Affiliation': 'Statistical Consultant, Stathmi, Inc., New Hope, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yamashita', 'Affiliation': 'Department of Bioanalytics and Drug Metabolism and Pharmacokinetics, Taiho Oncology, Inc., Princeton, USA.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.005']
85,31490311,Effect of Topical Garlic on Wound Healing and Scarring: A Clinical Trial.,"BACKGROUND


Historically, garlic containing compounds have been used on wounds to improve healing and ward off infection. Researchers have tested many of these ancient ointments, discovering that garlic is a common ingredient in those that are effective.
OBJECTIVE


To determine the efficacy of topical garlic on surgical wounds compared with Vaseline by analysis of visual analog scales and digital photograph analysis.
MATERIALS AND METHODS


Seventeen patients with 2 skin excisions applied a 30% garlic ointment to one surgical wound and Vaseline to the other surgical wound twice daily. They were followed up at 2 weeks and 4 weeks post-op. Digital photographs were taken of the sites, and wound visual analog scales were filled out by the patient and the physician.
RESULTS


Patients and the onsite physician stated the garlic site healed better in 59% and 65% of the wounds, respectively, at 2 weeks. At 4 weeks, the patients and the onsite physician stated the garlic site healed better in 76% and 88% of wounds, respectively. Digital photograph analysis revealed less erythema at the garlic sites (p-value = .02).
CONCLUSION


Surgical wounds treated with 30% garlic ointment healed with more cosmetically appealing scars than the Vaseline-treated sites.",2020,"Digital photograph analysis revealed less erythema at the garlic sites (p-value = .02).
",['Seventeen patients with 2 skin excisions applied a 30% garlic ointment to one surgical wound and Vaseline to the other surgical wound twice daily'],"['Topical Garlic', 'topical garlic']","['Wound Healing and Scarring', 'garlic site healed better', 'wound visual analog scales', 'cosmetically appealing scars']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0370612,"Digital photograph analysis revealed less erythema at the garlic sites (p-value = .02).
","[{'ForeName': 'Minhal', 'Initials': 'M', 'LastName': 'Alhashim', 'Affiliation': 'Department of Dermatology, Alhabib Medical Group, Khobar, Saudi Arabia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Lombardo', 'Affiliation': 'University of North Dakota, School of Medicine and Health Sciences, Grand Forks, North Dakota.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002123']
86,31899024,Comparative Effectiveness of Topically Administered Tranexamic Acid Versus Topical Oxymetazoline Spray for Achieving Hemostasis in Epistaxis.,"BACKGROUND


The use of tranexamic acid (TXA) has recently gained popularity as a treatment modality for epistaxis in the emergency department. Previous studies have compared topical TXA to nasal packing. However, topical TXA has not yet been compared with topical oxymetazoline in the treatment of epistaxis.
OBJECTIVES


This study compares the efficacy of the intravenous formulation of TXA applied topically vs. the vasoconstrictor oxymetazoline applied topically in achieving hemostasis in patients presenting to the emergency department with anterior epistaxis.
METHODS


In this prospective study, patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria, were allocated into 2 treatment groups; topical oxymetazoline vs. topical application of the intravenous preparation of TXA. Patients were assessed for time to hemostasis in the emergency department as well as the occurrence of rebleeding within the next 48 h after discharge.
RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group. While there were occurrences of rebleeding in the emergency department before discharge and at 48 h in both groups, 11 patients in the TXA group had no recurrence of bleeding compared with 5 in the oxymetazoline group.
CONCLUSION


This study demonstrated that the topical application of the intravenous preparation of TXA is more effective than topical oxymetazoline for achievement of hemostasis in anterior epistaxis. This has clinical significance toward preventing an avoidable need for escalation of treatment that could include applying nasal packing or cautery as well as preventing avoidable return emergency department visits. These outcomes would increase cost, potentially increase patient discomfort, and prolong emergency department throughput time.",2020,"RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group.","['patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria', 'Epistaxis', 'patients presenting to the emergency department with anterior epistaxis']","['tranexamic acid (TXA', 'vasoconstrictor oxymetazoline', 'topical TXA', 'topical oxymetazoline', 'oxymetazoline', 'TXA', 'Tranexamic Acid Versus Topical Oxymetazoline Spray', 'topical oxymetazoline vs. topical application of the intravenous preparation of TXA']","['recurrence of bleeding', 'occurrences of rebleeding', 'patient discomfort, and prolong emergency department throughput time', 'occurrence of rebleeding', 'time to hemostasis', 'Hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0339815', 'cui_str': 'Anterior epistaxis (disorder)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",,0.0246286,"RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Whitworth', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wisniewski', 'Affiliation': 'Michigan State University College of Osteopathic Medicine, East Lansing, Michigan.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Schrader', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.11.038']
87,32333510,"QR 678 & QR678 Neo Vs PRP-A randomised, comparative, prospective study.","BACKGROUND


Hair plays a significant role in shaping the appearance of an individual. Loss of hair can lead to serious effects on social esteem of an individual. The most common cause of hair loss is Androgenetic Alopecia (AGA).This hereditary disorder followed a specific pattern causing progressive thinning of hair in both Men and Women.
AIMS


The aim of the current study is to compare and evaluate the efficacy of QR678 therapy versus PRP in the treatment of Male Androgenetic Alopecia. Since QR678 and QR678 Neo have been found to be formulations equivalent in efficacy, the results would be the same with either formulation.
METHODS


A prospective, comparative, single-blind study was carried out with 2 groups of 25 patients each. Intradermal injections of QR678 formulations and PRP were injected in group A and B respectively. Hair pull test, Video microscopic assessment, Global Photographic assessment was done and patient's subjective assessment was done through questionnaire at the end of the study. Results were evaluated after 6 months and follow up was done till 1 year.
RESULTS


100% reduction in hair fall was noted at the end of 6 months in the QR678 group which was maintained for 1 year. Video microscopic evaluation showed that the hair density, terminal hair density, vellus hair density and shaft diameter were significantly better in QR678 group (P < .005) than the PRP group. Since QR678 and QR678 Neo formulatons are equivalent in efficacy, the results of tthis trial can be attributed to be the same, irrespective of the formulation used.
CONCLUSION


The bioengineered formulation of QR678 proved to be more beneficial for Male Androgenetic Alopecia (Male pattern hair loss) compared to PRP. A comparative study between QR678 and PRP with long term follow-up will widen our spectra of knowledge.",2020,"Video microscopic evaluation showed that the hair density, terminal hair density, vellus hair density and shaft diameter were significantly better in QR678 group (P < .005) than the PRP group.","['Male Androgenetic Alopecia', '2 groups of 25 patients each', 'Male Androgenetic Alopecia (Male pattern hair loss']","['QR678 formulations and PRP', 'QR678 therapy versus PRP', 'QR678 and PRP', 'QR678']","['hair density, terminal hair density, vellus hair density and shaft diameter', 'hair fall', 'Hair pull test, Video microscopic assessment, Global Photographic assessment', 'social esteem']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0221960', 'cui_str': 'Structure of terminal hair'}, {'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0337141', 'cui_str': 'Shaft'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]",,0.0177671,"Video microscopic evaluation showed that the hair density, terminal hair density, vellus hair density and shaft diameter were significantly better in QR678 group (P < .005) than the PRP group.","[{'ForeName': 'Rinky', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': 'Department of Dermatology, Cosmetic Dermatology & Dermato-Surgery, The Esthetic Clinics, Mumbai, India.'}, {'ForeName': 'Debraj', 'Initials': 'D', 'LastName': 'Shome', 'Affiliation': 'Deptartment of Facial Plastic Surgery and Facial Cosmetic Surgery, The Esthetic Clinics, Mumbai, India.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Vadera', 'Affiliation': 'Deptartment of Facial Plastic Surgery and Facial Cosmetic Surgery, The Esthetic Clinics, Mumbai, India.'}, {'ForeName': 'M Shiva', 'Initials': 'MS', 'LastName': 'Ram', 'Affiliation': 'The Esthetic Clinics, Mumbai, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13398']
88,32114612,Decreasing Delirium Through Music: A Randomized Pilot Trial.,"BACKGROUND


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


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


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


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


Music delivery is acceptable to patients and is feasible in intensive care units. Further research testing use of this promising intervention to reduce delirium is warranted.",2020,"Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable.","['Of the 1589 patients screened, 117 (7.4%) were eligible', 'patients receiving mechanical ventilation in an intensive care unit', 'academic medical-surgical intensive care unit']","['Music', 'listening to PM, relaxing STM, or an audiobook (AC group', 'noise-canceling headphones and used mp3 players to listen to their music/audiobook', 'personalized music (PM), slow-tempo music (STM), and attention control (AC']","['Delirium and delirium severity', 'Adherence', 'Median delirium severity', 'median number (interquartile range) of delirium/coma-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled (qualifier value)'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C2350433', 'cui_str': 'MP3-Player'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.285442,"Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable.","[{'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Sikandar H. Khan is an assistant professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and a scientist, Center for Aging Research, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Chenjia', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chenjia Xu is a doctoral student.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Purpura', 'Affiliation': 'Russell Purpura is an internal medicine resident, Department of Medicine, Indiana University School of Medicine.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Sana Durrani is a research associate, Center for Aging Research, Indiana University.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Heidi Lindroth is a T32 postdoctoral fellow, Center for Aging Research, Indiana University, and a postdoctoral fellow, Indiana University School of Nursing.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant professor, Department of Psychiatry, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Heiderscheit', 'Affiliation': 'Annie Heiderscheit is an associate professor of music and director of music therapy, Augsburg University, Minneapolis, Minnesota.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chlan', 'Affiliation': 'Linda Chlan is a professor, Department of Nursing, and associate dean, Nursing Research Division, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Malaz Boustani is a professor of medicine, Center for Aging Research, Indiana University, and a scientist, Center for Health Innovation and Implementation Science, Indianapolis, Indiana.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Babar A. Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and a scientist, Center for Aging Research, Indiana University.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020175']
89,32114617,Effect of Delirium on Physical Function in Noncardiac Thoracic Surgery Patients.,"BACKGROUND


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


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


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


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


Postoperative delirium was not associated with change in muscle strength. Follow-up studies using other muscle measures may be needed.",2020,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","['Exclusion criteria were history of schizophrenia, Parkinson disease, dementia, alcohol abuse, or neuroleptic malignant syndrome', 'patients undergoing noncardiac thoracic surgery', 'Seventy-three patients were included in the analysis', 'English-speaking adults aged 18 years or older who were undergoing major noncardiac thoracic surgery', 'Noncardiac Thoracic Surgery Patients']","['Delirium', 'delirium', 'levodopa or cholinesterase inhibitors', 'haloperidol']","['MRC-SS and Katz score by delirium status', 'MRC-SS', 'modified MRC-SS and functional independence', 'muscle strength', 'Katz scale of activities of daily living', 'Katz score', 'Delirium', 'Median (interquartile range) MRC-SS and Katz score', 'change in Medical Research Council sum score (MRC-SS) by delirium status', 'muscle strength and functional independence']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0455502', 'cui_str': 'H/O: schizophrenia'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1869046', 'cui_str': 'Neuroleptic malignant syndrome (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521309', 'cui_str': 'Cholinesterase inhibitor (disposition)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0222045'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]",73.0,0.148846,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","[{'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Sikandar H. Khan is an assistant research professor.'}, {'ForeName': 'Chenjia', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chenjia Xu is a doctoral student.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant clinical professor, Department of Psychiatry, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lasiter', 'Affiliation': 'Sue Lasiter is an associate professor, University of Missouri-Kansas City School of Nursing and Health Studies, Kansas City, Missouri.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kesler', 'Affiliation': 'Kenneth Kesler is a professor, Department of Cardiothoracic Surgery, Indiana University School of Medicine.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Babar A. Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and IU Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020579']
90,30366513,A positive psychology intervention for patients with bipolar depression: a randomized pilot trial.,"Background:  There are few effective treatments for bipolar depression, a common and debilitating illness. Aims:  We aimed to examine the feasibility and preliminary efficacy of a four-week, telephone-delivered positive psychology (PP) intervention for patients with bipolar depression. Methods:  Twenty-five patients hospitalized for bipolar depression were randomized to receive a PP ( n  = 14) or control condition (CC;  n  = 11) intervention. Following discharge, participants completed weekly exercises and phone calls with a study trainer. PP intervention feasibility was assessed by the number of exercises completed, and acceptability was examined on five-point Likert-type scales of ease and utility. Between-group differences on psychological constructs at 4 and 8 weeks post-enrollment were assessed using mixed effects regression models. Results:  Participants in the PP group completed an average of three out of four PP exercises and found PP exercises to be subjectively helpful, though neither easy nor difficult. Compared to CC, the PP intervention led to trends towards greater improvements in positive affect and optimism at follow-up, with large effect sizes (modified Cohen's  d  = 0.95-1.24). PP had variable, non-significant effects on negative psychological constructs. Conclusions:  Larger, randomized trials are needed to further evaluate the efficacy of this intervention in this high-risk population.",2020,"Compared to CC, the PP intervention led to trends towards greater improvements in positive affect and optimism at follow-up, with large effect sizes (modified Cohen's d = 0.95-1.24).","['patients with bipolar depression', 'Twenty-five patients hospitalized for bipolar depression']","['telephone-delivered positive psychology (PP) intervention', 'PP', 'positive psychology intervention', 'control condition (CC; n\u2009=\u200911) intervention', 'PP intervention']","['PP intervention feasibility', 'psychological constructs', 'number of exercises completed, and acceptability', 'negative psychological constructs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",25.0,0.166584,"Compared to CC, the PP intervention led to trends towards greater improvements in positive affect and optimism at follow-up, with large effect sizes (modified Cohen's d = 0.95-1.24).","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gomez-Bernal', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Mastromauro', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Eleanor E', 'Initials': 'EE', 'LastName': 'Beale', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'DuBois', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Randy P', 'Initials': 'RP', 'LastName': 'Auerbach', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2018.1521942']
91,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
92,31880632,Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy: A Randomized Controlled Trial.,"BACKGROUND


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


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


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


For anesthesiologists with experience in neuraxial ultrasonography, the use of ultrasound significantly reduces the technical difficulties of spinal anesthesia in patients with abnormal spinal anatomy compared with the landmark-guided technique. Our results can lead to practical suggestions that encourage the use of neuraxial ultrasonography for spinal anesthesia in such patients.",2020,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"['patients with anatomical alterations of the lumbar spine', 'Patients With Abnormal Spinal Anatomy', 'Forty-four patients with abnormal spinal anatomy including documented lumbar scoliosis and previous spinal surgery', 'patients with abnormal spinal anatomy']","['ultrasound-assisted technique', 'Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia', 'surface landmark-guided or preprocedural ultrasound-assisted spinal anesthesia', 'neuraxial ultrasonography']","['median (interquartile range [IQR; range]) number of needle passes', 'periprocedural pain scores', 'incidences of complications', 'success rate on the first pass, total procedure time, periprocedural pain scores, and the incidences of radicular pain, paresthesia, and bloody tap during the neuraxial procedure', 'total procedure time, defined as the sum of the time for identifying landmarks and performing spinal anesthesia', 'number of needle passes required for successful dural puncture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",44.0,0.0703103,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"[{'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004600']
93,32183498,"Histologic, Histomorphometric, and Clinical Analysis of the Effects of Growth Factors in a Fibrin Network Used in Maxillary Sinus Augmentation.","This randomized controlled clinical trial evaluated the effect of mineralized plasmatic matrix (MPM), comprised of synthetic graft and platelet concentrates, on new bone formation and volume stability over time in maxillary sinus lifting (MSL). Unilateral MSL was performed in 20 patients with either beta-tricalcium phosphate (β-TCP) or MPM grafts (10 sinuses each). Six months postsurgery, specimens were obtained with a trephine bur prior to implant placement in 39 cases. Volumetric changes in sinus augmentation were analyzed between 1 week (T-I) and 6 months (T-II) postsurgery. Histomorphometric and histological analyses of biopsy samples revealed mean new bone percentages of 35.40% ± 9.09% and 26.92% ± 7.26% and residual graft particle areas of 23.13% ± 6.16% and 32.25% ± 8.48% in the MPM and β-TCP groups, respectively ( p  < 0.05). The mean soft-tissue areas in the MPM and β-TCP groups were 41.48% ± 8.41% and 40.83% ± 8.86%, respectively ( p  > 0.05). Graft reductions between baseline and 6-months postprocedure in the β-TCP and MPM groups were 17.12% ± 13.55% and 14.41% ± 12.87%, respectively, with significant graft volume reduction observed in both groups ( p  < 0.05) while there is no significant difference between MPM and β-TCP groups ( p  > 0.05). Thus, MPM, representing growth factors in a fibrin network, increases new bone formation and has acceptable volume stability in MSL procedures.",2020,Volumetric changes in sinus augmentation were analyzed between 1 week (T-I) and 6 months (T-II) postsurgery.,"['20 patients with either', 'maxillary sinus lifting (MSL']","['mineralized plasmatic matrix (MPM', 'beta-tricalcium phosphate (β-TCP) or MPM grafts', 'Unilateral MSL', 'synthetic graft and platelet concentrates']","['graft volume reduction', 'Volumetric changes in sinus augmentation', 'Graft reductions', 'mean soft-tissue areas']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0181620', 'cui_str': 'Lift'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0106141', 'cui_str': 'tricalcium phosphate, beta phase'}, {'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0185104', 'cui_str': 'Synthetic graft'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2236586', 'cui_str': 'Sinus graft'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",20.0,0.0204863,Volumetric changes in sinus augmentation were analyzed between 1 week (T-I) and 6 months (T-II) postsurgery.,"[{'ForeName': 'Ihsan Caglar', 'Initials': 'IC', 'LastName': 'Cinar', 'Affiliation': 'Department of Oral Implantology, Istanbul University Faculty of Dentistry, Istanbul, 34093 Fatih, Turkey.'}, {'ForeName': 'Bahattin Alper', 'Initials': 'BA', 'LastName': 'Gultekin', 'Affiliation': 'Department of Oral Implantology, Istanbul University Faculty of Dentistry, Istanbul, 34093 Fatih, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Saglanmak', 'Affiliation': 'Department of Oral Implantology, Istanbul University Faculty of Dentistry, Istanbul, 34093 Fatih, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Yalcin', 'Affiliation': 'Department of Oral Implantology, Istanbul University Faculty of Dentistry, Istanbul, 34093 Fatih, Turkey.'}, {'ForeName': 'Vakur', 'Initials': 'V', 'LastName': 'Olgac', 'Affiliation': 'Pathology and Oncology Cytology Department of Institute of Oncology, Istanbul University, 34093 Fatih, Turkey.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Mijiritsky', 'Affiliation': 'Department of Otolaryngology, Head and Neck and Maxilllofacial Surgery, Tel-Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, 5219100 Ramat Aviv, Israel.'}]",International journal of environmental research and public health,['10.3390/ijerph17061918']
94,31197436,Acute prazosin administration does not reduce stressor reactivity in healthy adults.,"RATIONALE


Norepinephrine plays a critical role in the stress response. Clarifying the psychopharmacological effects of norepinephrine manipulation on stress reactivity in humans has important implications for basic neuroscience and treatment of stress-related psychiatric disorders, such as posttraumatic stress disorder and alcohol use disorders. Preclinical research implicates the norepinephrine alpha-1 receptor in responses to stressors. The No Shock, Predictable Shock, Unpredictable Shock (NPU) task is a human laboratory paradigm that is well positioned to test cross-species neurobiological stress mechanisms and advance experimental therapeutic approaches to clinical trials testing novel treatments for psychiatric disorders.
OBJECTIVES


We hypothesized that acute administration of prazosin, a noradrenergic alpha-1 antagonist, would have a larger effect on reducing stress reactivity during unpredictable, compared to predictable, stressors in the NPU task.
METHODS


We conducted a double-blind, placebo-controlled, crossover randomized controlled trial in which 64 healthy adults (32 female) completed the NPU task at two visits (2 mg prazosin vs. placebo).
RESULTS


A single acute dose of 2 mg prazosin did not reduce stress reactivity in a healthy adult sample. Neither NPU startle potentiation nor self-reported anxiety was reduced by prazosin (vs. placebo) during unpredictable (vs. predictable) stressors.
CONCLUSIONS


Further research is needed to determine whether this failure to translate preclinical neuroscience to human laboratory models is due to methodological factors (e.g., acute vs. chronic drug administration, brain penetration, study population) and/or suggests limited clinical utility of noradrenergic alpha-1 antagonists for treating stress-related psychiatric disorders.",2019,"Neither NPU startle potentiation nor self-reported anxiety was reduced by prazosin (vs. placebo) during unpredictable (vs. predictable) stressors.
","['64 healthy adults (32 female', 'healthy adult sample', 'healthy adults']","['Acute prazosin', 'placebo', 'prazosin', 'norepinephrine manipulation', 'prazosin vs. placebo', 'prazosin (vs. placebo']","['stressor reactivity', 'stress reactivity', 'NPU startle potentiation nor self-reported anxiety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",64.0,0.235328,"Neither NPU startle potentiation nor self-reported anxiety was reduced by prazosin (vs. placebo) during unpredictable (vs. predictable) stressors.
","[{'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Kaye', 'Affiliation': 'Department of Psychology, University of Wisconsin, Madison, WI, USA. jtkaye@wisc.edu.'}, {'ForeName': 'Gaylen E', 'Initials': 'GE', 'LastName': 'Fronk', 'Affiliation': 'Department of Psychology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Maireni R', 'Initials': 'MR', 'LastName': 'Cruz', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Curtin', 'Affiliation': 'Department of Psychology, University of Wisconsin, Madison, WI, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05297-x']
95,31592825,"Repeated Full-Face Aesthetic Combination Treatment With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin-Boosting Hyaluronic Acid After Monotherapy With AbobotulinumtoxinA or Hyaluronic Acid Filler.","BACKGROUND


Full-face aesthetic treatment involving several treatment modalities may improve facial aesthetic outcome.
OBJECTIVE


To evaluate clinical outcomes and patient perceptions of monotherapy with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by full-face combination treatments of ABO, HA filler, and skin-boosting HA (RSB).
MATERIALS AND METHODS


Subjects aged 35 to 50 years were randomized to monotherapy with 50 s.U ABO in the glabella or ≤1 mL HA filler in the nasolabial folds (NLFs)/cheeks. At Month 6 and Month 12, all subjects received combination treatment with ≤50 s.U ABO in the glabella, ≤2 mL HA filler in the NLFs/cheeks (and other facial areas as applicable), and ≤1 mL RSB (additional RSB treatment at Month 7). Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events.
RESULTS


Repeated full-face combination treatment with ABO, HA filler, and RSB was associated with considerably higher levels of aesthetic improvement and subject satisfaction than monotherapy with ABO or HA filler. Improvement rate of glabellar lines was increasing with each treatment.
CONCLUSION


Repeated combination treatment achieved greater change in global facial aesthetic appearance than monotherapy. Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated.",2020,Aesthetic improvement and subject satisfaction was high and increased with each treatment.,['Subjects aged 35 to 50 years'],"['monotherapy with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler', 'AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin-Boosting Hyaluronic Acid', 'monotherapy', 'AbobotulinumtoxinA or Hyaluronic Acid Filler']","['tolerated', 'facial aesthetic outcome', 'global facial aesthetic appearance', 'ABO, HA filler, and skin-boosting HA (RSB', 'Improvement rate of glabellar lines', 'Aesthetic improvement and subject satisfaction', 'global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events', 'aesthetic improvement and subject satisfaction']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0458485,Aesthetic improvement and subject satisfaction was high and increased with each treatment.,"[{'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Cartier', 'Affiliation': 'Centre Medical Saint-Jean, Arras, France.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hedén', 'Affiliation': 'Akademikliniken, Stockholm, Sweden.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Delmar', 'Affiliation': 'Mediti-Clinique Science et Beauté, Juan-les-Pins, France.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Bergentz', 'Affiliation': 'Akademikliniken, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Edwartz', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Norberg', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': 'Mediti-Clinique Science et Beauté, Juan-les-Pins, France.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002165']
96,32324888,"A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease.","Acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic cell transplantation (HCT) is a primary cause of nonrelapse mortality and a major barrier to successful transplant outcomes. Itacitinib is a Janus kinase (JAK)1-selective inhibitor that has demonstrated efficacy in preclinical models of aGVHD. We report results from the first registered study of a JAK inhibitor in patients with aGVHD. This was an open-label phase 1 study enrolling patients aged ≥18 years with first HCT from any source who developed grade IIB to IVD aGVHD. Patients with steroid-naive or steroid-refractory aGVHD were randomized 1:1 to itacitinib 200 mg or 300 mg once daily plus corticosteroids. The primary endpoint was safety and tolerability; day 28 overall response rate (ORR) was the main secondary endpoint. Twenty-nine patients (200 mg, n = 14; 300 mg, n = 15) received ≥1 dose of itacitinib and were included in safety and efficacy assessments. One dose-limiting toxicity was reported (grade 3 thrombocytopenia attributed to GVHD progression in a patient receiving 300 mg itacitinib with preexisting thrombocytopenia). The most common nonhematologic treatment-emergent adverse event was diarrhea (48.3%, n = 14); anemia occurred in 11 patients (38%). ORR on day 28 for all patients in the 200-mg and 300-mg groups was 78.6% and 66.7%, respectively. Day 28 ORR was 75.0% for patients with treatment-naive aGVHD and 70.6% in those with steroid-refractory aGVHD. All patients receiving itacitinib decreased corticosteroid use over time. In summary, itacitinib was well tolerated and demonstrated encouraging efficacy in patients with steroid-naive or steroid-refractory aGVHD, warranting continued clinical investigations. This trial was registered at www.clinicaltrials.gov as #NCT02614612.",2020,"ORR on day 28 for all patients in the 200-mg and 300-mg groups was 78.6% and 66.7%, respectively.","['patients with acute graft-versus-host disease', 'Patients with steroid-naive or steroid-refractory aGVHD', 'patients aged ≥18 years with first HCT from any source who developed grade IIB to IVD aGVHD', 'patients with aGVHD']","['JAK inhibitor', 'Acute graft-versus-host disease (aGVHD', 'itacitinib, a selective JAK1 inhibitor', 'allogeneic hematopoietic cell transplantation (HCT', 'itacitinib 200 mg or 300 mg once daily plus corticosteroids']","['anemia', 'diarrhea', 'safety and tolerability; day 28 overall response rate (ORR', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C3854325', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0169658', 'cui_str': 'JAK1 Protein Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0808937,"ORR on day 28 for all patients in the 200-mg and 300-mg groups was 78.6% and 66.7%, respectively.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schroeder', 'Affiliation': 'Division of Oncology, Section of Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'H Jean', 'Initials': 'HJ', 'LastName': 'Khoury', 'Affiliation': 'Division of Hematology, Winship Cancer Institute of Emory School of Medicine, Atlanta, GA.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Jagasia', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schiller', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Staser', 'Affiliation': 'Department of Dermatology, Washington University School of Medicine in St Louis, St Louis, MO.'}, {'ForeName': 'Jaebok', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Division of Oncology, Section of Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Gehrs', 'Affiliation': 'Division of Oncology, Section of Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Arbushites', 'Affiliation': 'Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langmuir', 'Affiliation': 'Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Srinivas', 'Affiliation': 'Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pratta', 'Affiliation': 'Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Miguel-Angel', 'Initials': 'MA', 'LastName': 'Perales', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yi-Bin', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': 'Massachusetts General Hospital, Boston, MA; and.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Meyers', 'Affiliation': 'Department of Medicine, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Division of Oncology, Section of Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, St. Louis, MO.'}]",Blood advances,['10.1182/bloodadvances.2019001043']
97,32286644,Effect of Preemptive Therapy vs Antiviral Prophylaxis on Cytomegalovirus Disease in Seronegative Liver Transplant Recipients With Seropositive Donors: A Randomized Clinical Trial.,"Importance


Despite the use of a cytomegalovirus (CMV) prevention strategy of antiviral prophylaxis for high-risk CMV-seronegative liver transplant recipients with seropositive donors, high rates of delayed-onset postprophylaxis CMV disease occur. An alternate approach, preemptive therapy (initiation of antiviral therapy for early asymptomatic CMV viremia detected by surveillance testing), has not previously been directly compared with antiviral prophylaxis in these patients.
Objective


To compare preemptive therapy with antiviral prophylaxis in CMV-seronegative liver transplant recipients with seropositive donors for the prevention of CMV disease.
Design, Setting, and Participants


Randomized clinical trial of preemptive therapy vs antiviral prophylaxis in 205 CMV-seronegative liver transplant recipients with seropositive donors aged older than 18 years. The trial was conducted at 6 academic transplant centers in the United States between October 2012 and June 2017, with last follow-up in June 2018.
Interventions


Patients were randomized 1:1 to receive either preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests a week apart) for viremia detected by weekly plasma CMV polymerase chain reaction for 100 days (n = 100) or valganciclovir, 900 mg, daily for 100 days as antiviral prophylaxis (n = 105).
Main Outcomes and Measures


The primary outcome was incidence of CMV disease by 12 months, defined as CMV syndrome (CMV viremia and clinical or laboratory findings) or end-organ disease. Secondary outcomes included acute allograft rejection, opportunistic infections, graft and patient survival, and neutropenia.
Results


Among 205 patients who were randomized (mean age, 55 years; 62 women [30%]), all 205 (100%) completed the trial. The incidence of CMV disease was significantly lower with preemptive therapy than antiviral prophylaxis (9% [9/100] vs 19% [20/105]; difference, 10% [95% CI, 0.5% to 19.6%]; P = .04]). The incidence of allograft rejection (28% vs 25%; difference, 3% [95% CI, -9% to 15%]), opportunistic infections (25% vs 27%; difference, 2% [95% CI, -14% to 10%]), graft loss (2% vs 2%; difference, <1% [95% CI, -4% to 4%]), and neutropenia (13% vs 10%; difference, 3% [95% CI, -5% to 12%]) did not differ significantly for the preemptive therapy vs antiviral prophylaxis group, respectively. All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
Conclusions and Relevance


Among CMV-seronegative liver transplant recipients with seropositive donors, the use of preemptive therapy, compared with antiviral prophylaxis, resulted in a lower incidence of CMV disease over 12 months. Further research is needed to replicate these findings and assess long-term outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01552369.",2020,"All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
","['Seronegative Liver Transplant Recipients', ' 62 women [30%]), all 205 (100%) completed the trial', '205 patients who were randomized (mean age, 55 years', 'CMV-seronegative liver transplant recipients with seropositive donors', 'high-risk CMV-seronegative liver transplant recipients with seropositive donors', 'CMV-seronegative liver transplant recipients with seropositive donors for the prevention of CMV disease', 'With Seropositive Donors', '205 CMV-seronegative liver transplant recipients with seropositive donors aged older than 18 years', '6 academic transplant centers in the United States between October 2012 and June 2017, with last follow-up in June 2018']","['cytomegalovirus (CMV', 'Preemptive Therapy vs Antiviral Prophylaxis', 'preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests a week apart) for viremia detected by weekly plasma CMV polymerase chain reaction', 'valganciclovir', 'antiviral prophylaxis', 'preemptive therapy vs antiviral prophylaxis']","['acute allograft rejection, opportunistic infections, graft and patient survival, and neutropenia', 'opportunistic infections', 'incidence of CMV disease', 'graft loss', 'incidence of allograft rejection', 'neutropenia', 'CMV disease', 'Cytomegalovirus Disease', 'incidence of CMV disease by 12 months, defined as CMV syndrome (CMV viremia and clinical or laboratory findings) or end-organ disease']","[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877137', 'cui_str': 'Antiviral prophylaxis'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C1735634', 'cui_str': 'Acute allograft rejection'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1112469', 'cui_str': 'Cytomegalovirus syndrome'}, {'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.112,"All-cause mortality at last follow-up was 15% in the preemptive therapy vs 19% in the antiviral prophylaxis group (difference, 4% [95% CI, -14% to 6%]; P = .46).
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': 'University of California Los Angeles Medical Center, Los Angeles.'}, {'ForeName': 'Raymund R', 'Initials': 'RR', 'LastName': 'Razonable', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'G Marshall', 'Initials': 'GM', 'LastName': 'Lyon', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Wagener', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stevens-Ayers', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Edmison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ajit P', 'Initials': 'AP', 'LastName': 'Limaye', 'Affiliation': 'University of Washington, Seattle.'}]",JAMA,['10.1001/jama.2020.3138']
98,32183453,Randomized Trial Examining Effects of Animal Assisted Intervention and Stress Related Symptoms on College Students' Learning and Study Skills.,"Animal Visitation Programs (AVPs) targeting college students' stress and academic success have increased, despite limited research on academic outcomes. This randomized controlled trial ( N  = 349) examined the effects of incorporating levels of Human-animal Interaction (HAI) (0%, 50% or 100%) with therapy dogs in a four-week academic stress management program. Conditions included (1) Academic Stress Management (ASM) content only (0% HAI) ,  (2) Human-animal Interaction only (100% HAI) and (3) equal combinations of ASM content and HAI (50% HAI). Intention-to-treat (ITT) analyses examined the effects of students' risk status ( N  = 146; depression, anxiety, perceived stress, worry) and treatment condition on students' learning and study strategies at posttest and follow-up. The results showed interactions between condition and risk status demonstrating higher posttest levels of WILL (i.e., anxiety, attitude, motivation) ( Β  = 0.582,  p  = 0.005) and SELFREGULATION (i.e., concentration, self-testing, study aids, time management) ( Β  = 0.501,  p  = 0.031) for at-risk students receiving equal combinations of HAI and content presentations. Moderation effects remained at follow-up ( Β  = 0.626,  p  = 0.005;  Β  = 0.630,  p  = 0.007). At-risk students receiving only HAI (100%) also showed higher levels of WILL at posttest ( Β  = 0.481,  p  = 0.021) and follow up ( Β  = 0.490,  p  = 0.038). University administrators should consider providing at-risk students with targeted programs with varying levels of HAI and ASM content, depending on the targeted academic outcome.",2020,"At-risk students receiving only HAI (100%) also showed higher levels of WILL at posttest ( Β  = 0.481,  p  = 0.021) and follow up ( Β  = 0.490,  p  = 0.038).","[""students' risk status ( N  = 146; depression, anxiety, perceived stress, worry) and treatment condition on students' learning and study strategies at posttest and follow-up"", ""College Students' Learning and Study Skills""]","['Animal Visitation Programs (AVPs', 'Human-animal Interaction (HAI', 'Animal Assisted Intervention and Stress Related Symptoms', 'Intention-to-treat (ITT']","['posttest levels of WILL (i.e., anxiety, attitude, motivation', 'Moderation effects', 'Conditions included (1) Academic Stress Management (ASM) content only (0% HAI) ,  (2) Human-animal Interaction']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}]","[{'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0169855,"At-risk students receiving only HAI (100%) also showed higher levels of WILL at posttest ( Β  = 0.481,  p  = 0.021) and follow up ( Β  = 0.490,  p  = 0.038).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pendry', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA 99164, USA.'}, {'ForeName': 'Alexa M', 'Initials': 'AM', 'LastName': 'Carr', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA 99164, USA.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Gee', 'Affiliation': 'Center for Human-Animal Interaction, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Jaymie L', 'Initials': 'JL', 'LastName': 'Vandagriff', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA 99164, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17061909']
99,32321570,Health and economic outcomes of treatment with extended-release naltrexone among pre-release prisoners with opioid use disorder (HOPPER): protocol for an evaluation of two randomized effectiveness trials.,"BACKGROUND


Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole.
METHODS


This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative ""value"" of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials.
DISCUSSION


Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.",2020,"Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets.","['Persons with an opioid use disorder (OUD', 'pre-release prisoners with opioid use disorder (HOPPER']","['extended-release naltrexone', 'naltrexone (XR-NTX']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]",[],,0.0326477,"Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets.","[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY, 10065, USA. smm2010@med.cornell.edu.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY, 10065, USA.'}, {'ForeName': 'Sabrina A', 'Initials': 'SA', 'LastName': 'Poole', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY, 10065, USA.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Vocci', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Woody', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'Department of Health Policy and Management, Bloomberg School of Public Health, Carey Business School, Johns Hopkins University, Baltimore, MD, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-020-00188-5']
100,31309977,Aerobic and Resistance Exercise Improves Shoulder Function in Women Who Are Overweight or Obese and Have Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND


Adverse upper limb musculoskeletal effects occur after surgical procedures and radiotherapy for breast cancer and can interfere with activities of daily living.
OBJECTIVE


The objective of this study was to examine the effects of a 16-week exercise intervention on shoulder function in women who are overweight or obese and have breast cancer.
DESIGN


This study was a randomized controlled trial.
SETTING


The study was performed at the Division of Biokinesiology and Physical Therapy at the University of Southern California.
PARTICIPANTS


One hundred women with breast cancer were randomly allocated to exercise or usual-care groups. The mean (SD) age of the women was 53.5 (10.4) years, 55% were Hispanic white, and their mean (SD) body mass index was 33.5 (5.5) kg/m2.
INTERVENTION


The 16-week exercise intervention consisted of supervised, progressive, moderate to vigorous aerobic and resistance exercise 3 times per week.
MEASUREMENTS


Shoulder active range of motion, isometric muscular strength, and patient-reported outcome measures (including Disabilities of the Arm, Shoulder, and Hand and the Penn Shoulder Scale) were assessed at baseline, after the intervention, and at the 3-month follow-up (exercise group only). Differences in mean changes for outcomes were evaluated using mixed-model repeated-measures analysis.
RESULTS


Compared with the usual-care group, the exercise group experienced significant increases in shoulder active range of motion (the mean between-group differences and 95% confidence intervals (CIs) were as follows: shoulder flexion = 36.6° [95% CI = 55.2-20.7°], external rotation at 0° = 23.4° [95% CI = 31.1-12.5°], and external rotation at 90° = 34.3° [95% CI = 45.9-26.2°]), improved upper extremity isometric strength, and improved Disabilities of the Arm, Shoulder, and Hand and Penn Shoulder Scale scores.
LIMITATIONS


Limitations include a lack of masking of assessors after the intervention, an attention control group, and statistical robustness (shoulder function was a secondary end point).
CONCLUSIONS


A 16-week exercise intervention effectively improved shoulder function following breast cancer treatment in women who were overweight or obese, who were ethnically diverse, and who had breast cancer.",2019,"Compared with the usual-care group, the exercise group experienced significant increases in shoulder active range of motion (the mean between-group differences and 95% confidence intervals were as follows: shoulder flexion =","['The mean age of the women was 53.5 (SD = 10.4) years, 55% were Hispanic white, and their body mass index was 33.5 (SD = 5.5) kg/m2', 'The study was performed at the Division of Biokinesiology and Physical Therapy at the University of Southern California', 'Who Are Overweight or Obese and Have Breast Cancer', 'women who are overweight or obese and have breast cancer', 'A total of 100 women with breast cancer', 'women who were overweight or obese, who were ethnically diverse, and who had breast cancer', 'Women']","['Aerobic and Resistance Exercise', 'exercise or usual-care groups', 'radiotherapy', 'exercise intervention', 'exercise intervention consisted of supervised, progressive, moderate to vigorous aerobic and resistance exercise 3 times per week']","['Shoulder active range of motion, isometric muscular strength, and patient-reported outcome measures (including Disabilities of the Arm, Shoulder, and Hand and the Penn Shoulder Scale', 'external rotation', 'improved upper extremity isometric strength, and improved Disabilities of the Arm, Shoulder, and Hand and Penn Shoulder Scale scores', 'shoulder active range of motion', 'shoulder function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222045'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",100.0,0.0763979,"Compared with the usual-care group, the exercise group experienced significant increases in shoulder active range of motion (the mean between-group differences and 95% confidence intervals were as follows: shoulder flexion =","[{'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sweeney', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sami', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kimiko', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California.'}, {'ForeName': 'Darcy V', 'Initials': 'DV', 'LastName': 'Spicer', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Bernstein', 'Affiliation': 'Division of Biomarkers of Early Detection and Prevention, Beckman Research Institute, City of Hope, Duarte, California.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mortimer', 'Affiliation': 'Division of Medical Oncology and Experimental Therapeutics, City of Hope.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Department of Supportive Care Medicine, City of Hope, 1500 East Duarte Road, Duarte, CA 91010 (USA).'}]",Physical therapy,['10.1093/ptj/pzz096']
101,32325257,"A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.","BACKGROUND


The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days.
PATIENTS AND METHODS


In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy.
RESULTS


Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was -1.52% [95% confidence interval (CI): -3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95% CI: -2.73% to -0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: -3.17%, 95% CI: -9.51% to 3.18%).
CONCLUSION


Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. CLINICALTRIALS.
GOV REGISTRATION


NCT02428114 and NCT02816164.",2020,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"['early breast cancer (EBC) patients', 'Patient (N=466', 'November 2017 allowed subsequent patients (N=324', 'early stage breast cancer', 'EBC patients who were to receive filgrastim as primary FN prophylaxis']","['filgrastim', 'G-CSF (filgrastim']","['overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalization', 'risk of either FN or treatment-related hospitalisation per cycle', 'events per cycle for FN', 'composite of either FN or treatment-related hospitalisations', 'chemotherapy dose reductions, delays, and discontinuations', 'febrile neutropenia']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.248534,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simos', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Califaretti', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zibdawi', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahl', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raphael', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada; Division of Medical Oncology, London Regional Cancer Program, Western University, London, Canada.'}, {'ForeName': 'M F K', 'Initials': 'MFK', 'LastName': 'Ibrahim', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'The Northeast Cancer Centre, Sudbury, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.005']
102,32227754,Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.,"BACKGROUND


In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2  or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.
METHODS


We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy.
RESULTS


Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4).
CONCLUSIONS


Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","['Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease', 'Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease', 'participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2  or receipt of dialysis', 'Health status was assessed in 705 of 777 participants']",['guideline-based medical therapy alone (conservative strategy'],"['health status with the Seattle Angina Questionnaire (SAQ', 'frequent angina and better function and quality of life', 'overall trial population', 'SAQ Summary score', 'risk of death or myocardial infarction']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",777.0,0.272639,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916374']
103,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND


Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.
METHODS


We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
RESULTS


At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
CONCLUSIONS


Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925']
104,31373868,Can Persons with Dementia Meaningfully Participate in Advance Care Planning Discussions? A Mixed-Methods Study of SPIRIT.,"Background:  Despite the importance of persons with dementia (PWDs) engaging in advance care planning (ACP) at a time when they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions, studies of ACP in PWDs are rare.  Objective:  We conducted an intervention development study to adapt an efficacious ACP intervention, SPIRIT (sharing patient's illness representations to increase trust), for PWDs in early stages (recent Montreal Cognitive Assessment [MoCA] score ≥13) and their surrogates and assess whether SPIRIT could help PWDs engage in ACP.  Design:  A formative expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews, was conducted. Patient-surrogate dyads were randomized to SPIRIT  in person  (in a private room in a memory clinic) or SPIRIT  remote  (via videoconferencing from home).  Setting/Subjects:  Twenty-three dyads of PWDs and their surrogates were recruited from an outpatient brain health center. Participants completed preparedness outcome measures (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) at baseline and two to three days post-intervention, plus a semistructured interview. Levels of articulation of end-of-life wishes of PWDs during SPIRIT sessions were rated (3 = expressed wishes very coherently, 2 = somewhat coherently, and 1 = unable to express coherently).  Results:  All 23 were able to articulate their end-of-life wishes very or somewhat coherently during the SPIRIT session; of those, 14 PWDs had moderate dementia. While decision-making capacity was higher in PWDs who articulated their wishes very coherently, MoCA scores did not differ by articulation levels. PWDs and surrogates perceived SPIRIT as beneficial, but the preparedness outcomes did not change pre-post.  Conclusions:  SPIRIT engaged PWDs and surrogates in meaningful ACP discussions, but requires testing of efficacy and long-term outcomes.",2019,"While decision-making capacity was higher in PWDs who articulated their wishes very coherently, MoCA scores did not differ by articulation levels.","['Setting/Subjects:  Twenty-three dyads of PWDs and their surrogates were recruited from an outpatient brain health center', 'persons with dementia (PWDs', 'Patient-surrogate dyads']",['SPIRIT  in person  (in a private room in a memory clinic) or SPIRIT  remote  (via videoconferencing from home'],"['moderate dementia', 'Levels of articulation of end-of-life wishes of PWDs', 'preparedness outcome measures (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C3494871', 'cui_str': 'Moderate dementia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",23.0,0.050111,"While decision-making capacity was higher in PWDs who articulated their wishes very coherently, MoCA scores did not differ by articulation levels.","[{'ForeName': 'Mi-Kyung', 'Initials': 'MK', 'LastName': 'Song', 'Affiliation': 'Center for Nursing Excellence in Palliative Care, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Ward', 'Affiliation': 'School of Nursing, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul, Korea.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Family Medicine and Rush Alzheimer's Disease Center, University of Chicago, Chicago, Illinois.""}, {'ForeName': 'Darby J', 'Initials': 'DJ', 'LastName': 'Morhardt', 'Affiliation': ""Department of Preventive Medicine, Cognitive Neurology and Alzheimer's Disease Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Medders', 'Affiliation': 'Emory Integrated Memory Care Clinic, Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Lah', 'Affiliation': 'Department of Neurology, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carolyn C', 'Initials': 'CC', 'LastName': 'Clevenger', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0088']
105,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4']
106,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I.
RESULTS


Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
CONCLUSIONS


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
107,31548349,Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance).,"PURPOSE


Previous studies have suggested that higher circulating 25-hydroxyvitamin D [25(OH)D] levels are associated with decreased colorectal cancer risk and improved survival. However, the influence of vitamin D status on disease progression and patient survival remains largely unknown for patients with advanced or metastatic colorectal cancer.
EXPERIMENTAL DESIGN


We prospectively collected blood samples in 1,041 patients with previously untreated advanced or metastatic colorectal cancer participating in a randomized phase III clinical trial of first-line chemotherapy plus biologic therapy. We examined the association of baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS). Cox proportional hazards models were used to calculate hazard ratios (HRs) and confidence intervals (CIs), adjusted for prognostic factors and confounders.
RESULTS


At study entry, 63% of patients were vitamin D deficient (<20 ng/mL) and 31% were vitamin D insufficient (20-<30 ng/mL). Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend  = 0.0009 and 0.03, respectively). Compared with patients in the bottom quintile of 25(OH)D (≤10.8 ng/mL), those in the top quintile (≥24.1 ng/mL) had a multivariable-adjusted HR of 0.66 (95% CI, 0.53-0.83) for OS and 0.81 (95% CI, 0.66-1.00) for PFS. The improved survival associated with higher 25(OH)D levels was consistent across patient subgroups of prognostic patient and tumor characteristics.
CONCLUSIONS


In this large cohort of patients with advanced or metastatic colorectal cancer, higher plasma 25(OH)D levels were associated with improved OS and PFS. Clinical trials assessing the benefit of vitamin D supplementation in patients with colorectal cancer are warranted.",2019,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","['Patients with Advanced or Metastatic Colorectal Cancer', 'CRC patients', '1,041 patients with previously untreated advanced or metastatic CRC participating in a randomized phase III clinical trial of first-line', 'patients with advanced or metastatic CRC']","['chemotherapy plus biologic therapy', 'vitamin D supplementation']","['colorectal cancer (CRC) risk and improved survival', 'survival', 'Plasma 25-Hydroxyvitamin D Levels and Survival', 'circulating 25-hydroxyvitamin D [25(OH)D] levels', 'OS and PFS', 'Higher 25(OH)D levels', 'baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS', 'plasma 25(OH)D levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1041.0,0.182611,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. chen_yuan@dfci.harvard.edu.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Chang', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, North Carolina.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy and Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Department of Medicine, University of California San Francisco (UCSF) School of Medicine, San Francisco, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0877']
108,31968207,Effects of the Carrier Phrase on Word Recognition Performances by Younger and Older Listeners Using Two Stimulus Paradigms.,"BACKGROUND


In the 1950s, with monitored live voice testing, the vu meter time constant and the short durations and amplitude modulation characteristics of monosyllabic words necessitated the use of the carrier phrase amplitude to monitor (indirectly) the presentation level of the words. This practice continues with recorded materials. To relieve the carrier phrase of this function, first the influence that the carrier phrase has on word recognition performance needs clarification, which is the topic of this study.
PURPOSE


Recordings of Northwestern University Auditory Test No. 6 by two female speakers were used to compare word recognition performances with and without the carrier phrases when the carrier phrase and test word were (1) in the same utterance stream with the words excised digitally from the carrier (VA-1 speaker) and (2) independent of one another (VA-2 speaker). The 50-msec segment of the vowel in the target word with the largest root mean square amplitude was used to equate the target word amplitudes.
RESEARCH DESIGN


A quasi-experimental, repeated measures design was used.
STUDY SAMPLE


Twenty-four young normal-hearing adults (YNH;  M  = 23.5 years; pure-tone average [PTA] = 1.3-dB HL) and 48 older hearing loss listeners (OHL;  M  = 71.4 years; PTA = 21.8-dB HL) participated in two, one-hour sessions.
DATA COLLECTION AND ANALYSES


Each listener had 16 listening conditions (2 speakers × 2 carrier phrase conditions × 4 presentation levels) with 100 randomized words, 50 different words by each speaker. Each word was presented 8 times (2 carrier phrase conditions × 4 presentation levels [YNH, 0- to 24-dB SL; OHL, 6- to 30-dB SL]). The 200 recorded words for each condition were randomized as 8, 25-word tracks. In both test sessions, one practice track was followed by 16 tracks alternated between speakers and randomized by blocks of the four conditions. Central tendency and repeated measures analyses of variance statistics were used.
RESULTS


With the VA-1 speaker, the overall mean recognition performances were 6.0% (YNH) and 8.3% (OHL) significantly better with the carrier phrase than without the carrier phrase. These differences were in part attributed to the distortion of some words caused by the excision of the words from the carrier phrases. With the VA-2 speaker, recognition performances on the with and without carrier phrase conditions by both listener groups were not significantly different, except for one condition (YNH listeners at 8-dB SL). The slopes of the mean functions were steeper for the YNH listeners (3.9%/dB to 4.8%/dB) than for the OHL listeners (2.4%/dB to 3.4%/dB) and were <1%/dB steeper for the VA-1 speaker than for the VA-2 speaker. Although the mean results were clear, the variability in performance differences between the two carrier phrase conditions for the individual participants and for the individual words was striking and was considered in detail.
CONCLUSION


The current data indicate that word recognition performances with and without the carrier phrase (1) were different when the carrier phrase and target word were produced in the same utterance with poorer performances when the target words were excised from their respective carrier phrases (VA-1 speaker), and (2) were the same when the carrier phrase and target word were produced as independent utterances (VA-2 speaker).",2020,"With the VA-2 speaker, recognition performances on the with and without carrier phrase conditions by both listener groups were not significantly different, except for one condition (YNH listeners at 8-dB SL).","['SAMPLE\n\n\nTwenty-four young normal-hearing adults (YNH; M = 23.5 years; pure-tone average [PTA] = 1.3-dB HL) and 48 older hearing loss listeners (OHL; M = 71.4 years; PTA = 21.8-dB HL', 'Northwestern University Auditory Test No. 6 by two female speakers', 'Younger and Older Listeners']","['Carrier Phrase', 'VA-1 speaker']","['Word Recognition Performances', 'overall mean recognition performances']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",24.0,0.0220376,"With the VA-2 speaker, recognition performances on the with and without carrier phrase conditions by both listener groups were not significantly different, except for one condition (YNH listeners at 8-dB SL).","[{'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Department of Speech and Hearing Sciences, Arizona State University, Tempe, AZ.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Sanchez', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.19061']
109,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


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


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


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


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
110,32323557,"Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","BACKGROUND


Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG.
METHODS


This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals.
RESULTS


The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL,  P  = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P  < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P  = .006) and remained higher in vitamin D group after CPB ( P  < .001).
CONCLUSIONS


These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.",2020,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).",['70 patients undergoing CABG with CPB'],"['Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB', 'Coronary Artery Bypass Surgery', 'vitamin D. Vitamin D', 'Placebo', 'placebo', 'Vitamin D', 'vitamin D']","['serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1', 'average number of positive cells', 'Heart Apoptosis', 'IL-10', 'apoptosis rate', 'serum levels of IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",70.0,0.638586,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).","[{'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Tasdighi', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Hekmat', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Beheshti', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Baghaei', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohsen', 'Initials': 'SM', 'LastName': 'Mirhosseini', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Torbati', 'Affiliation': 'Department of Pathology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Pourmotahari', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnoosh', 'Initials': 'M', 'LastName': 'Foroughi', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420920495']
111,32160058,Cryotherapy Models and Timing-Sequence Recovery of Exercise-Induced Muscle Damage in Middle- and Long-Distance Runners.,"CONTEXT


Among sports-recovery methods, cold-water immersion (CWI), contrast-water therapy (CWT), and whole-body cryotherapy (WBC) have been applied widely to enhance recovery after strenuous exercise. However, the different timing effects in exercise-induced muscle damage (EIMD) after these recovery protocols remain unknown.
OBJECTIVE


To compare the effects of CWI, CWT, and WBC on the timing-sequence recovery of EIMD through different indicator responses.
DESIGN


Crossover study.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


Twelve male middle- and long-distance runners from the Beijing Sport University (age = 21.00 ± 0.95 years).
INTERVENTION(S)


Participants were treated with different recovery methods (control [CON], CWI, CWT, WBC) immediately postexercise and at 24, 48, and 72 hours postexercise.
MAIN OUTCOME MEASURE(S)


We measured perceived sensation using a visual analog scale (VAS), plasma creatine kinase (CK) activity, plasma C-reactive protein (CRP) activity, and vertical-jump height (VJH) pre-exercise, immediately postexercise, and at 1, 24, 48, 72, and 96 hours postexercise.
RESULTS


For the VAS score and CK activity, WBC exhibited better timing-sequence recovery effects than CON and CWI ( P  < .05), but the CWT demonstrated better effects than CON ( P  < .05). The CRP activity was lower after WBC than after the other interventions ( P  < .05). The VJH was lower after WBC than after CON and CWI ( P  < .05).
CONCLUSIONS


The WBC positively affected VAS, CK, CRP, and VJH associated with EIMD. The CWT and CWI also showed positive effects. However, for the activity and timing-sequence effect, CWT had weaker effects than WBC.",2020,The CRP activity was lower after WBC than after the other interventions ( P  < .05).,"['Middle- and Long-Distance Runners', 'Twelve male middle- and long-distance runners from the Beijing Sport University (age = 21.00 ± 0.95 years']","['cold-water immersion (CWI), contrast-water therapy (CWT), and whole-body cryotherapy (WBC', 'CWI, CWT, and WBC']","['VAS score and CK activity', 'CRP activity', 'perceived sensation using a visual analog scale (VAS), plasma creatine kinase (CK) activity, plasma C-reactive protein (CRP) activity, and vertical-jump height (VJH) pre-exercise, immediately postexercise', 'WBC positively affected VAS, CK, CRP, and VJH associated with EIMD']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]",12.0,0.0320918,The CRP activity was lower after WBC than after the other interventions ( P  < .05).,"[{'ForeName': 'Chaoyi', 'Initials': 'C', 'LastName': 'Qu', 'Affiliation': 'Department of Exercise Physiology, Beijing Sport University, China.'}, {'ForeName': 'Zhaozhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Sport Biological Center, China Institute of Sport Science, Beijing.'}, {'ForeName': 'Minxiao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Sport Biological Center, China Institute of Sport Science, Beijing.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Qin', 'Affiliation': 'Sport Biological Center, China Institute of Sport Science, Beijing.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Sport Biological Center, China Institute of Sport Science, Beijing.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Sport Biological Center, China Institute of Sport Science, Beijing.'}, {'ForeName': 'Jiexiu', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Exercise Physiology, Beijing Sport University, China.'}]",Journal of athletic training,['10.4085/1062-6050-529-18']
112,32135451,Effect of neuromuscular training augmented with knee valgus control instructions on lower limb biomechanics of male runners.,"OBJECTIVE


To examine if combining neuromuscular training (NMT) with knee valgus control instructions (VCIs) can affect lower limb biomechanics and injury incidence in male novice runners and assess over 1-year follow-up.
DESIGN


Controlled laboratory Study.
SETTING


University research laboratory.
PARTICIPANTS


60 male novice runners randomly assigned into NMT (n = 20), NMT plus VCIs (n = 20), and sham (n = 20).
MAIN OUTCOME MEASURES


Kinematic and kinetic were measured at pre- and post-test and 1-year follow-up. Injury incidence assessed at pre-test and 1-year follow up.
RESULTS


There were significant between-group differences in kinetics after 6 weeks in NMT plus VCIs group. No significant differences were observed between NMT and NMT plus VCIs in kinematic variables. No significant change was seen in the sham in all variables. At 1-year follow-up, the minimal changes were seen in kinetic variables. Reduction reported running-related injuries were 31.58% in the NMT alone group, 65.52% in NMT plus VCIs group. In sham, it increased to 13.46%.
CONCLUSIONS


NMT plus VCIs was effective to reduce kinetics and improve kinematics in novice runners. Also, it could reduce injury incidence. This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.",2020,This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.,"['novice runners', 'male runners', 'male novice runners', 'University research laboratory', '60 male novice runners randomly assigned into']","['neuromuscular training augmented with knee valgus control instructions', 'neuromuscular training (NMT) with knee valgus control instructions (VCIs', 'NMT', 'NMT plus VCIs']",['Kinematic and kinetic'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",60.0,0.112322,This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran. Electronic address: letafatkaramir@yahoo.com.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Rabiei', 'Affiliation': 'Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: Pouya.Rabiei@vub.be.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Afshari', 'Affiliation': 'Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran. Electronic address: minaafshar.ma8@gmail.com.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.02.009']
113,32143084,The effect of body weight reduction using a lower body positive pressure treadmill on plantar pressure measures while running.,"OBJECTIVE


To evaluate the effects of body weight reduction at 10% intervals on pressure distribution variables across regions of the foot while running.
STUDY DESIGN


Crossover Study Design.
SETTING


Laboratory.
PARTICIPANTS


12 recreational runners.
MAIN OUTCOME MEASURES


Pressure-time integral, peak pressure, instance of peak pressure, contact area, contact time and center of pressure (COP) location at initial contact across four foot regions were measured while participants ran at self-selected speed on the Lower Body Positive Pressure Treadmill (LBPPT) at 100%, 90%, 80%, 70% and 60% of their body weight (%BW).
RESULTS


As the %BW decreased, there were corresponding significant decreases in the pressure-time integral and peak pressures in all four regions of the foot. Significant differences within foot region and %BW for the other variables were infrequent. There was a significant anterior shift of the COP location at initial contact as the %BW decreased.
CONCLUSION


LBPPT is useful for reducing the pressure across the entire foot. Additionally, the anterior translation of the COP location at initial contact with reduced %BW may provide an additional gait retraining tool for prevention and treatment of running injuries as reducing %BW moves the runner away from a rearfoot strike pattern.",2020,"As the %BW decreased, there were corresponding significant decreases in the pressure-time integral and peak pressures in all four regions of the foot.",['12 recreational runners'],"['body weight reduction using a lower body positive pressure treadmill', 'LBPPT']","['Lower Body Positive Pressure Treadmill (LBPPT', 'body weight reduction', 'pressure-time integral and peak pressures', 'COP location', 'Pressure-time integral, peak pressure, instance of peak pressure, contact area, contact time and center of pressure (COP) location at initial contact across four foot regions']",[],"[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.0303033,"As the %BW decreased, there were corresponding significant decreases in the pressure-time integral and peak pressures in all four regions of the foot.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hodges-Long', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cross', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA. Electronic address: kevin.cross@virginia.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Magrum', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Feger', 'Affiliation': 'Curry School of Education, Department of Kinesiology, University of Virginia, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Curry School of Education, Department of Kinesiology, University of Virginia, Charlottesville, VA, 22903, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.02.011']
114,31565869,The Impact of Timing of Exercise Initiation on Weight Loss: An 18-Month Randomized Clinical Trial.,"OBJECTIVE


This study aimed to evaluate the impact of timing of exercise initiation on weight loss within a behavioral weight loss program.
METHODS


Adults with overweight or obesity (N = 170; age 18-55 years; BMI 25-42 kg/m 2  ; 83.5% women) were enrolled in an 18-month behavioral weight loss program consisting of a reduced-calorie diet, exercise, and group-based support. The standard group (STD) received a supervised exercise program (progressing to 300 min/wk of moderate-intensity aerobic exercise) during months 0 to 6. The sequential group (SEQ) was asked to refrain from changing exercise during months 0 to 6 and received the supervised exercise program during months 7 to 12. On completion of supervised exercise, both groups were instructed to continue 300 min/wk of moderate-intensity exercise for the study duration.
RESULTS


At 6 months, the STD group exhibited greater reductions in body weight (-8.7 ± 0.7 kg) compared with the SEQ group (-6.9 ± 0.6 kg; P = 0.047). Between 6 and 18 months, the STD group regained more weight (2.5 ± 0.8 kg vs. 0.0 ± 0.8 kg; P = 0.02). At 18 months, there were no between-group differences in changes in weight (STD: -6.9 ± 1.2 kg; SEQ: -7.9 ± 1.2 kg), fat mass, lean mass, physical activity, or attrition.
CONCLUSIONS


Both immediate and delayed exercise initiation within a behavioral weight loss program resulted in clinically meaningful weight loss at 18 months. Thus, timing of exercise initiation can be personalized based on patient preference.",2019,"At 6 months, the STD group exhibited greater reductions in body weight (-8.7 ± 0.7 kg) compared with the SEQ group (-6.9 ± 0.6 kg; P = 0.047).","['Adults with overweight or obesity', 'N\u2009=\u2009170; age\xa018-55 years; BMI 25-42 kg/m 2  ; 83.5% women) were enrolled in an 18-month']","['behavioral weight loss program consisting of a reduced-calorie diet, exercise, and group-based support', 'exercise initiation', 'sequential group (SEQ) was asked to refrain from changing exercise during months 0 to 6 and received the supervised exercise program', 'supervised exercise program (progressing to 300 min/wk of moderate-intensity aerobic exercise', 'Exercise Initiation']","['fat mass, lean mass, physical activity, or attrition', 'body weight', 'clinically meaningful weight loss', 'weight loss', 'weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",300.0,0.0669966,"At 6 months, the STD group exhibited greater reductions in body weight (-8.7 ± 0.7 kg) compared with the SEQ group (-6.9 ± 0.6 kg; P = 0.047).","[{'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bing', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Liza T', 'Initials': 'LT', 'LastName': 'Wayland', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Seyoum', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Stauffer', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology and Public Health and Center for Health Research, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22624']
115,32320144,Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.,"OBJECTIVE


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


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


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


Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.",2020,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","['participants with overweight/obesity and type 2 diabetes', 'Two years after the end of the intervention (EOI), ILI and DSE participants', 'Weight Change 2 Years']","['ILI and DSE', '10-year intensive lifestyle intervention (ILI', 'Intensive Lifestyle Intervention']","['cardiovascular morbidity and mortality', 'EOI weight', 'gain weight', 'weight-control behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",,0.0402555,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Gay', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Integrative Physiology and Metabolism, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Michalski', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22769']
116,32291802,A pilot randomized controlled trial of hearing aids to improve mood and cognition in older adults.,"OBJECTIVES


Age-related hearing loss (ARHL) is a prevalent condition associated with increased risk for depression and cognitive decline. This 12-week prospective, double-blind pilot randomized controlled trial (RCT) of hearing aids (HAs) for depressed older adults with ARHL evaluated the feasibility of a novel research design.
METHODS/DESIGN


N = 13 individuals aged ≥60 years with Major Depressive Disorder or Persistent Depressive Disorder and at least mild hearing loss (pure tone average ≥ 30 dB) were randomized to receive full- (active) vs low-amplification (sham) HAs added to psychiatric treatment as usual. Duration of HA use in hours/day, adverse events frequency, attrition rate, and maintenance of the study blinding were the primary outcome measures.
RESULTS


Compliance with HAs was excellent (>9 hours/day for both groups) and rates of adverse events and drop-outs did not differ between groups. Preliminary data demonstrated differential improvement for active vs sham HAs on hearing functioning (Hearing Handicap Inventory for the Elderly [nonparametric effect size (np-ES) = 0.62]), depressive symptoms (Inventory for Depressive Symptomatology [np-ES = 0.31]), cognition (Repeatable Battery for the Assessment of Neuropsychological Status Immediate Memory [np-ES = 0.25]), and general functioning (World Health Organization Disability Assessment Schedule [np-ES = 0.53]). Significantly greater than 50% of both groups correctly guessed their treatment assignment, indicating incomplete concealment of treatment allocation.
CONCLUSIONS


This pilot RCT for ARHL and late-life depression was feasible to execute and showed clinical promise, but improved methods of blinding the experimental treatments are needed. Larger studies should investigate whether hearing remediation may be an effective preventative and/or therapeutic strategy for late-life depression and cognitive decline.",2020,"Preliminary data demonstrated differential improvement for active vs. sham HAs on hearing functioning (Hearing Handicap Inventory for the Elderly [nonparametric effect size (np-ES) =.62]), depressive symptoms (Inventory for Depressive Symptomatology [np-ES=.31]), cognition (Repeatable Battery for the Assessment of Neuropsychological Status Immediate Memory [np-ES=.25]), and general functioning (World Health Organization Disability Assessment Schedule [np-ES=.53]).","['depressed older adults with ARHL', 'N=13 individuals aged ≥60\u2009years with Major Depressive Disorder or Persistent Depressive Disorder and at least mild hearing loss (pure tone average ≥30dB', 'Older Adults']","['Hearing Aids', 'full', 'hearing aids (HAs']","['hearing functioning (Hearing Handicap Inventory', 'rates of adverse events', 'Duration of HA use in hours/day, adverse events frequency, attrition rate, and maintenance of the study blinding', 'depressive symptoms', 'Mood and Cognition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",13.0,0.294852,"Preliminary data demonstrated differential improvement for active vs. sham HAs on hearing functioning (Hearing Handicap Inventory for the Elderly [nonparametric effect size (np-ES) =.62]), depressive symptoms (Inventory for Depressive Symptomatology [np-ES=.31]), cognition (Repeatable Battery for the Assessment of Neuropsychological Status Immediate Memory [np-ES=.25]), and general functioning (World Health Organization Disability Assessment Schedule [np-ES=.53]).","[{'ForeName': 'Katharine K', 'Initials': 'KK', 'LastName': 'Brewster', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Mailman School of Public Health, New York, New York, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'New York State Psychiatric Institute, New York, New York, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'New York State Psychiatric Institute, New York, New York, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Ana H', 'Initials': 'AH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Golub', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brickman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Galatioto', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kuhlmey', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Bret R', 'Initials': 'BR', 'LastName': 'Rutherford', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5311']
117,31538372,Differential Posttreatment Outcomes of Methylphenidate for Smoking Cessation for Individuals With ADHD.,"BACKGROUND AND OBJECTIVES


In a multisite, randomized study (CTN-0029), a 3-month course of Osmotic-Release Oral System Methylphenidate (OROS-MPH) improved smoking cessation in a group of patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD). This treatment, however, worsened smoking cessation outcome in the group with lower baseline ADHD severity. We want to examine whether this differential treatment effect persisted after OROS-MPH was discontinued.
METHODS


We conducted a secondary analysis of the 1-month follow-up data from CTN-0029 after the discontinuation of OROS-MPH (N = 134). Nicotine patch was tapered during this month. We tested whether OROS-MPH had an effect on self-reported 7-day abstinence by week, as well as possible treatment by baseline ADHD severity interactions.
RESULTS


Abstinence diminished overall in time after the end of the treatment. In the high baseline severity group, patients who received OROS-MPH had an advantage in 7-day abstinence at week 15 (40% for OROS-MPH vs 20% for placebo, odds ratio = 2.63, P = .028). In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups. There was also a significant treatment by baseline ADHD severity interaction (P = .03).
CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE


OROS-MPH promotes abstinence beyond the course of treatment for patients with more severe ADHD, while the paradoxical effects in the lower baseline severity group is not persistent after medication discontinuation. Targeting ADHD in smoking cessation as a comorbidity therefore can have broader impact with more precise patient selection. (Am J Addict).",2019,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","['patients with more severe ADHD', 'patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD', 'Individuals With ADHD']","['OROS-MPH', 'Osmotic-Release Oral System Methylphenidate (OROS-MPH', 'Nicotine patch', 'Methylphenidate']","['7-day abstinence', 'baseline ADHD severity interaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.240385,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","[{'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Division of Addiction Sciences, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}]",The American journal on addictions,['10.1111/ajad.12961']
118,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0']
119,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z']
120,32320566,Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease.,"BACKGROUND


Acute graft-versus-host disease (GVHD) remains a major limitation of allogeneic stem-cell transplantation; not all patients have a response to standard glucocorticoid treatment. In a phase 2 trial, ruxolitinib, a selective Janus kinase (JAK1 and JAK2) inhibitor, showed potential efficacy in patients with glucocorticoid-refractory acute GVHD.
METHODS


We conducted a multicenter, randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with the investigator's choice of therapy from a list of nine commonly used options (control) in patients 12 years of age or older who had glucocorticoid-refractory acute GVHD after allogeneic stem-cell transplantation. The primary end point was overall response (complete response or partial response) at day 28. The key secondary end point was durable overall response at day 56.
RESULTS


A total of 309 patients underwent randomization; 154 patients were assigned to the ruxolitinib group and 155 to the control group. Overall response at day 28 was higher in the ruxolitinib group than in the control group (62% [96 patients] vs. 39% [61]; odds ratio, 2.64; 95% confidence interval [CI], 1.65 to 4.22; P<0.001). Durable overall response at day 56 was higher in the ruxolitinib group than in the control group (40% [61 patients] vs. 22% [34]; odds ratio, 2.38; 95% CI, 1.43 to 3.94; P<0.001). The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group and 39% in the control group. The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60). The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (hazard ratio for death, 0.83; 95% CI, 0.60 to 1.15). The most common adverse events up to day 28 were thrombocytopenia (in 50 of 152 patients [33%] in the ruxolitinib group and 27 of 150 [18%] in the control group), anemia (in 46 [30%] and 42 [28%], respectively), and cytomegalovirus infection (in 39 [26%] and 31 [21%]).
CONCLUSIONS


Ruxolitinib therapy led to significant improvements in efficacy outcomes, with a higher incidence of thrombocytopenia, the most frequent toxic effect, than that observed with control therapy. (Funded by Novartis; REACH2 ClinicalTrials.gov number, NCT02913261.).",2020,"The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60).","['patients 12 years of age or older who had glucocorticoid-refractory acute GVHD after allogeneic stem-cell transplantation', '309 patients underwent randomization; 154 patients were assigned to the ruxolitinib group and 155 to the control group', 'patients with glucocorticoid-refractory acute GVHD']",['oral ruxolitinib'],"['efficacy outcomes', 'efficacy and safety', 'hazard ratio for relapse or progression of hematologic disease, non-relapse-related death', 'thrombocytopenia', 'Overall response', 'Durable overall response', 'anemia', 'cumulative incidence of loss of response', 'median failure-free survival', 'durable overall response', 'median overall survival', 'overall response (complete response or partial response', 'cytomegalovirus infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}]",309.0,0.161116,"The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zeiser', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'von Bubnoff', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Mohty', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Reuven', 'Initials': 'R', 'LastName': 'Or', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Tsila', 'Initials': 'T', 'LastName': 'Zuckerman', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Bruyère', 'Initials': 'B', 'LastName': 'Mahuzier', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Kunal K', 'Initials': 'KK', 'LastName': 'Gandhi', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1917635']
121,32320637,Dibutyl Phthalate Augments Allergen-induced Lung Function Decline and Alters Human Airway Immunology. A Randomized Crossover Study.,"Rationale:  Phthalates are a group of chemicals used in common commercial products. Epidemiological studies suggest that phthalate exposure is associated with development or worsening of allergic diseases such as asthma. However, effects of dibutyl phthalate (DBP) or other phthalates found in high concentrations in indoor air have never been examined in allergic individuals in a controlled exposure setting. Objectives:  To investigate the airway effects in humans caused by inhalation of a known concentration of a single phthalate, DBP. Methods:  In a randomized crossover study, 16 allergen-sensitized participants were exposed to control air or DBP for 3 hours in an environmental chamber followed immediately by an allergen inhalation challenge. Bronchoalveolar wash and lavage were obtained 24 hours after exposure. Lung function, early allergic response, airway responsiveness, inflammation, immune mediators, and immune cell phenotypes were assessed after DBP exposure. Measurements and Main Results:  DBP exposure increased the early allergic response (21.4% decline in FEV 1  area under the curve,  P  = 0.03). Airway responsiveness was increased by 48.1% after DBP exposure in participants without baseline hyperresponsiveness ( P  = 0.01). DBP increased the recruitment of BAL total macrophages by 4.6% ( P  = 0.07), whereas the M2 macrophage phenotype increased by 46.9% ( P  = 0.04). Airway immune mediator levels were modestly affected by DBP. Conclusions:  DBP exposure augmented allergen-induced lung function decline, particularly in those without baseline hyperresponsiveness, and exhibited immunomodulatory effects in the airways of allergic individuals. This is the first controlled human exposure study providing biological evidence for phthalate-induced effects in the airways.Clinical trial registered with www.clinicaltrials.gov (NCT02688478).",2020,DBP increased the recruitment of bronchoalveolar lavage total macrophages by 4.6% (p=0.07) while the M2 macrophage phenotype increased by 46.9% (p=0.04).,['16 allergen-sensitized participants'],"['dibutyl phthalate (DBP', 'control air or DBP']","['Airway immune mediator levels', 'Airway responsiveness', 'Lung function, early allergic response, airway responsiveness, inflammation, immune mediators and immune cell phenotypes', 'early allergic response', 'Lung Function Decline and Alters Human Airway Immunology', 'bronchoalveolar lavage total macrophages', 'M2 macrophage phenotype']","[{'cui': 'C0002092', 'cui_str': 'Allergen'}]","[{'cui': 'C0012052', 'cui_str': 'Dibutyl Phthalate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1527304', 'cui_str': 'Allergic reaction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]",16.0,0.104556,DBP increased the recruitment of bronchoalveolar lavage total macrophages by 4.6% (p=0.07) while the M2 macrophage phenotype increased by 46.9% (p=0.04).,"[{'ForeName': 'Danay', 'Initials': 'D', 'LastName': 'Maestre-Batlle', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Huff', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Carley', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Alexis', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Tebbutt', 'Affiliation': 'Department of Medicine & PROOF Centre of Excellence, and.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Turvey', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anette K', 'Initials': 'AK', 'LastName': 'Bølling', 'Affiliation': 'Department of Air Pollution and Noise, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Department of Medicine.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2153OC']
122,31806653,"Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).","OBJECTIVE


To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS


Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs.
RESULTS


Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91;  P  = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo ( P  = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914;  P  ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914;  P  < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204;  P  < 0.01). There were no significant differences in EQ-5D health utilities between arms over time.
CONCLUSIONS


Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.",2020,"There were no significant differences in EQ-5D health utilities between arms over time.
","['14,752 patients with type 2 diabetes', 'Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL']","['placebo', 'EQW', 'exenatide (EQW) or placebo']","['Rates of outpatient medical visits', 'English costs', 'estimated cost of EQW, total mean costs', 'total costs', 'Mean costs for nonstudy diabetes medications', 'Costs, and Quality of Life', 'EQ-5D health utilities', 'mean total costs, including exenatide costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]",1670.0,0.094758,"There were no significant differences in EQ-5D health utilities between arms over time.
","[{'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC shelby.reed@duke.edu.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gustavson', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Kartman', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wittbrodt', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0950']
123,31569161,"Prevention of Early Postoperative Decline: A Randomized, Controlled Feasibility Trial of Perioperative Cognitive Training.","BACKGROUND


Postoperative delirium and postoperative cognitive dysfunction (POCD) are common after cardiac surgery and contribute to an increased risk of postoperative complications, longer length of stay, and increased hospital mortality. Cognitive training (CT) may be able to durably improve cognitive reserve in areas deficient in delirium and POCD and, therefore, may potentially reduce the risk of these conditions. We sought to determine the feasibility and potential efficacy of a perioperative CT program to reduce the incidence of postoperative delirium and POCD in older cardiac surgery patients.
METHODS


Randomized controlled trial at a single tertiary care center. Participants included 45 older adults age 60-90 undergoing cardiac surgery at least 10 days from enrollment. Participants were randomly assigned in a 1:1 fashion to either perioperative CT via a mobile device or a usual care control. The primary outcome of feasibility was evaluated by enrollment patterns and adherence to protocol. Secondary outcomes of postoperative delirium and POCD were assessed using the Confusion Assessment Method and the Montreal Cognitive Assessment, respectively. Patient satisfaction was assessed via a postoperative survey.
RESULTS


Sixty-five percent of eligible patients were enrolled. Median (interquartile range [IQR]) adherence (as a percentage of prescribed minutes played) was 39% (20%-68%), 6% (0%-37%), and 19% (0%-56%) for the preoperative, immediate postoperative, and postdischarge periods, respectively. Median (IQR) training times were 245 (136-536), 18 (0-40), and 122 (0-281) minutes for each period, respectively. The incidence of postoperative delirium (CT group 5/20 [25%] versus control 3/20 [15%]; P = .69) and POCD (CT group 53% versus control 37%; P = .33) was not significantly different between groups for either outcome in this limited sample. CT participants reported a high level of agreement (on a scale of 0-100) with statements that the program was easy to use (median [IQR], 87 [75-97]) and enjoyable (85 [79-91]). CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study.
CONCLUSIONS


A CT program designed for use in the preoperative period is an attractive target for future investigations of cognitive prehabilitation in older cardiac surgery patients. Changes in the functionality of the program and enrichment techniques may improve adherence in future trials. Further investigation is necessary to determine the potential efficacy of cognitive prehabilitation to reduce the risk of postoperative delirium and POCD.",2020,"CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study.
","['Sixty-five percent of eligible patients were enrolled', 'Early Postoperative Decline', 'older cardiac surgery patients', 'Participants included 45 older adults age 60-90 undergoing cardiac surgery at least 10 days from enrollment']","['perioperative CT via a mobile device or a usual care control', 'CT', 'perioperative CT program', 'Perioperative Cognitive Training', 'Cognitive training (CT']","['Median (interquartile range [IQR]) adherence', 'hospital mortality', 'Patient satisfaction', 'postoperative delirium and POCD', 'Confusion Assessment Method and the Montreal Cognitive Assessment', 'Median (IQR) training times', 'incidence of postoperative delirium', 'POCD', 'thinking ability']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3496286'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",45.0,0.2064,"CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study.
","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': ""O'Gara"", 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Doris Vanessa I', 'Initials': 'DVI', 'LastName': 'Gasangwa', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Patxot', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Shaefi', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Khabbaz', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascal-Leone', 'Affiliation': 'Department of Neurology, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004469']
124,31571412,Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial.,"OBJECTIVE


Insulin resistance is associated with increased lipolysis and elevated concentrations of free fatty acids (FFA), which in turn contribute to impaired vascular function. It was hypothesized that lowering FFA with acipimox, a nicotinic acid derivative that impairs FFA efflux, would improve endothelial function, measured by flow-mediated dilation (FMD), in individuals with metabolic syndrome.
METHODS


A total of 18 participants with metabolic syndrome and 17 healthy controls were enrolled and treated with acipimox 250 mg orally every 6 hours or placebo for 7 days in a randomized, double-blind, crossover trial.
RESULTS


Acipimox reduced FFA concentrations among individuals with metabolic syndrome to near normal levels (P = 0.01), but there was no change among healthy controls (P = 0.17). Acipimox did not improve endothelial-dependent FMD in either group (metabolic syndrome: P = 0.42; healthy controls: P = 0.16), although endothelial-independent nitroglycerin-mediated dilation among those with metabolic syndrome tended to increase (20.3%, P = 0.06). There were no changes in blood lipids or markers of inflammation following therapy. There was minimal correlation between change in FMD and baseline measures of BMI ( ρ = -0.09) or waist circumference ( ρ = -0.15).
CONCLUSIONS


In groups with normal or elevated baseline FFA, short-term reductions do not improve endothelial function assessed by FMD.",2019,"RESULTS


Acipimox reduced FFA concentrations among individuals with metabolic syndrome to near normal levels (P = 0.01), but there was no change among healthy controls (P = 0.17).","['18 participants with metabolic syndrome and 17 healthy controls', 'individuals with metabolic syndrome', 'Metabolic Syndrome']","['Acipimox', 'acipimox', 'Acipimox Therapy', 'acipimox 250 mg orally every 6 hours or placebo']","['FMD and baseline measures of BMI', 'Free Fatty Acid Efflux and Endothelial Function', 'FFA concentrations', 'endothelial-dependent FMD', 'blood lipids or markers of inflammation', 'waist circumference', 'endothelial function']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0050558', 'cui_str': 'acipimox'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1126722', 'cui_str': 'acipimox 250 MG'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",18.0,0.289808,"RESULTS


Acipimox reduced FFA concentrations among individuals with metabolic syndrome to near normal levels (P = 0.01), but there was no change among healthy controls (P = 0.17).","[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Aday', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Gregory', 'Affiliation': 'Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Beckman', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22602']
125,32268439,Does the pre-emptive administration of paracetamol or ibuprofen reduce trans- and post-operative pain in primary molar extraction? A randomized placebo-controlled clinical trial.,"BACKGROUND


There is no consensus whether the pre-emptive administration of analgesics reduces trans- and post-operative pain in primary molar extraction.
AIM


Investigate whether the pre-emptive administration of ibuprofen and paracetamol reduces trans- and post-operative pain on primary molars extraction compared to placebo.
DESIGN


A parallel, placebo-controlled, triple-blind, randomized clinical trial was conducted. Forty-eight children who needed primary molar tooth extraction were selected and treated under local anaesthesia and pre-emptive administration of placebo or analgesics. Self-reported pain was evaluated during the anaesthesia, extraction, and 2, 6, and 24 hours of post-operative period, using a visual analogue scale (VAS). Children's baseline anxiety, behaviour during the procedure, parents' anxiety, and post-operative analgesia were also assessed. Data analysis included descriptive statistics and multiple linear regression.
RESULTS


No association was found between the use of pre-emptive analgesic and lower scores of trans- and post-operative pain compared to placebo. Children who presented negative behaviour reported greater pain during anaesthesia (P = .04) regardless of pre-emptive analgesia group. Children from the placebo group were more likely to need post-operative analgesia at 2 hours of follow-up (P = .03).
CONCLUSION


The pre-emptive administration of analgesics did not significantly reduce trans- and post-operative pain in children after primary molars extraction.",2020,The pre-emptive administration of analgesics did not significantly reduce trans and postoperative pain in children after primary molars extraction.,['Forty-eight children who needed primary molar tooth extraction were selected and treated under'],"['local anesthesia and pre-emptive administration of placebo or analgesics', 'ibuprofen and paracetamol', 'placebo', 'paracetamol or ibuprofen']","['pre-emptive analgesic and lower scores of trans and postoperative pain', 'Visual Analogue Scale (VAS', 'pain', 'trans and postoperative pain', ""Children's baseline anxiety, behavior during the procedure, parents' anxiety and postoperative analgesia"", 'need postoperative analgesia', 'Self-reported pain']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",48.0,0.522144,The pre-emptive administration of analgesics did not significantly reduce trans and postoperative pain in children after primary molars extraction.,"[{'ForeName': 'Pablo Silveira', 'Initials': 'PS', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Massignan', 'Affiliation': 'Postgraduate Program in Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Elisa Varela', 'Initials': 'EV', 'LastName': 'de Oliveira', 'Affiliation': 'School of Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Miranda Santana', 'Affiliation': 'Department of Pediatric Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Department of Pediatric Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Department of Pediatric Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.'}]",International journal of paediatric dentistry,['10.1111/ipd.12649']
126,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


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


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


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


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
127,31689359,Interventions for prodromal stage of psychosis.,"BACKGROUND


Psychosis is a serious mental condition characterised by a loss of contact with reality. There may be a prodromal period or stage of psychosis, where early signs of symptoms indicating onset of first episode psychosis (FEP) occur. A number of services, incorporating multimodal treatment approaches (pharmacotherapy, psychotherapy and psychosocial interventions), developed worldwide, now focus on this prodromal period with the aim of preventing psychosis in people at risk of developing FEP.
OBJECTIVES


The primary objective is to assess the safety and efficacy of early interventions for people in the prodromal stage of psychosis. The secondary objective is, if possible, to compare the effectiveness of the various different interventions.
SEARCH METHODS


We searched Cochrane Schizophrenia's study-based Register of studies (including trials registers) on 8 June 2016 and 4 August 2017.
SELECTION CRITERIA


All randomised controlled trials (RCTs) evaluating interventions for participants older than 12 years, who had developed a prodromal stage of psychosis.
DATA COLLECTION AND ANALYSIS


Review authors independently inspected citations, selected studies, extracted data, and assessed study quality.
MAIN RESULTS


We included 20 studies with 2151 participants. The studies analysed 13 different comparisons. Group A comparisons explored the absolute effects of the experimental intervention. Group B were comparisons within which we could not be clear whether differential interactive effects were also ongoing. Group C comparisons explored differential effects between clearly distinct treatments. A key outcome for this review was 'transition to psychosis'. For details of other main outcomes please see 'Summary of findings' tables. In Group A (comparisons of absolute effects) we found no clear difference between amino acids and placebo (risk ratio (RR) 0.48 95% confidence interval (CI) 0.08 to 2.98; 2 RCTs, 52 participants; very low-quality evidence). When omega-3 fatty acids were compared to placebo, fewer participants given the omega-3 (10%) transitioned to psychosis compared to the placebo group (33%) during long-term follow-up of seven years (RR 0.24 95% CI 0.09 to 0.67; 1 RCT, 81 participants; low-quality evidence). In Group B (comparisons where complex interactions are probable) and in the subgroup focusing on antipsychotic drugs added to specific care packages, the amisulpiride + needs-focused intervention (NFI) compared to NFI comparison (no reporting of transition to psychosis; 1 RCT, 102 participants; very low-quality evidence) and the olanzapine + supportive intervention compared to supportive intervention alone comparison (RR 0.58 95% CI 0.28 to 1.18; 1 RCT, 60 participants; very low-quality evidence) showed no clear differences between groups. In the second Group B subgroup (cognitive behavioural therapies (CBT)), when CBT + supportive therapy was compared with supportive therapy alone around 8% of participants allocated to the combination of CBT and supportive therapy group transitioned to psychosis during follow-up by 18 months, compared with double that percentage in the supportive therapy alone group (RR 0.45 95% CI 0.23 to 0.89; 2 RCTs, 252 participants; very low-quality evidence). The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence). Group C (differential effects) also involved six comparisons. The first compared CBT with supportive therapy. No clear difference was found for the 'transition to psychosis' outcome (RR 0.74 95% CI 0.28 to 1.98; 1 RCT, 72 participants; very low-quality evidence). The second subgroup compared CBT + supportive intervention was compared with a NBI + supportive intervention, again, data were equivocal, few and of very low quality (RR 6.32 95% CI 0.34 to 117.09; 1 RCT, 57 participants). In the CBT + risperidone versus supportive therapy comparison, again there was no clear difference between groups (RR 0.76 95% CI 0.28 to 2.03; 1 RCT, 71 participants; very low-quality evidence). The three other comparisons in Group C demonstrated no clear differences between treatment groups. When cognitive training was compared to active control (tablet games) (no reporting of transition to psychosis; 1 RCT, 62 participants; very low quality data), family treatment compared with enhanced care comparison (RR 0.54 95% CI 0.18 to 1.59; 2 RCTs, 229 participants; very low-quality evidence) and integrated treatment compared to standard treatment comparison (RR 0.57 95% CI 0.28 to 1.15; 1 RCT, 79 participants; very low-quality evidence) no effects of any of these approaches was evident.
AUTHORS' CONCLUSIONS


There has been considerable research effort in this area and several interventions have been trialled. The evidence available suggests that omega-3 fatty acids may prevent transition to psychosis but this evidence is low quality and more research is needed to confirm this finding. Other comparisons did not show any clear differences in effect for preventing transition to psychosis but again, the quality of this evidence is very low or low and not strong enough to make firm conclusions.",2019,"The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence).","['20 studies with 2151 participants', 'participants older than 12 years, who had developed a prodromal stage of psychosis', 'people at risk of developing FEP', 'prodromal stage of psychosis', 'people in the prodromal stage of psychosis', ""Cochrane Schizophrenia's study-based Register of studies (including trials registers) on 8 June 2016 and 4 August 2017""]","['CBT + risperidone', 'CBT + placebo', 'cognitive behavioural therapies (CBT', 'CBT + supportive therapy', 'olanzapine + supportive intervention', 'CBT and supportive therapy', 'multimodal treatment approaches (pharmacotherapy, psychotherapy and psychosocial interventions', 'placebo', 'omega-3 fatty acids']","['safety and efficacy', ""transition to psychosis' outcome""]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3494361', 'cui_str': 'Prodromal Stage'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",252.0,0.277609,"The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence).","[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Bosnjak Kuharic', 'Affiliation': 'University Psychiatric Hospital Vrapče, Bolnicka cesta 32, Zagreb, Grad Zagreb, Croatia, 10000.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kekin', 'Affiliation': 'Clinical Hospital Centre Zagreb, Department of Psychiatry, Kispaticeva 12, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hew', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Department of Acute Care Psychiatry, Ladywell Unit, University Hospital Lewisham, London, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rojnic Kuzman', 'Affiliation': 'Clinical Hospital Centre Zagreb, Department of Psychiatry, Kispaticeva 12, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Catholic University of Croatia, Center for Evidence-Based Medicine and Health Care, Ilica 242, Zagreb, Croatia, 10000.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012236.pub2']
128,32109160,Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial.,"BACKGROUND


Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue.
HYPOTHESIS


Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority.
RESULTS


The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose,  P  = .04; low dose,  P  = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose,  P  = .006; low dose,  P  = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported.
CONCLUSION


Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA.
REGISTRATION


NCT02726945 (ClinicalTrials.gov identifier).",2020,"The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose,  P  = .04; low dose,  P  = .02).","['Knee Osteoarthritis', 'Adult patients with symptomatic knee OA were eligible', 'Thirty-nine patients']","['placebo', 'Intra-articular SVF injections', 'Autologous stromal vascular fraction (SVF', 'SVF, low-dose SVF, or placebo', 'Intra-articular Mesenchymal Stromal Cells']","['serious adverse events', 'efficacy and safety', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images', 'WOMAC scores', 'WOMAC score', 'knee OA symptoms and pain', 'cartilage thickness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}]",39.0,0.626145,"The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose,  P  = .04; low dose,  P  = .02).","[{'ForeName': 'Jaime R', 'Initials': 'JR', 'LastName': 'Garza', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Campbell', 'Affiliation': 'Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fotios P', 'Initials': 'FP', 'LastName': 'Tjoumakaris', 'Affiliation': 'Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Freedman', 'Affiliation': 'Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Miller', 'Affiliation': 'Cooper University Hospital, Camden, New Jersey, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Maria', 'Affiliation': 'Sports Medicine Associates of San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Bradford S', 'Initials': 'BS', 'LastName': 'Tucker', 'Affiliation': 'Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, USA.'}]",The American journal of sports medicine,['10.1177/0363546519899923']
129,32268807,Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial.,"BACKGROUND


Inconclusive noninvasive tests complicate the care of patients with suspected coronary artery disease, but their prevalence and impact on management, outcomes, and costs are not well described.
METHODS


PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) patients were randomized to stress testing (n=4533) or computed tomographic angiography (CTA; n=4677). We assessed relationships between inconclusive results, subsequent testing, a composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures.
RESULTS


Overall, 8.0% of tests were inconclusive (9.7% stress, 6.4% CTA). Compared with negative tests, inconclusive tests were more often referred to a second noninvasive test (stress: 14.6% versus 8.5%, odds ratio [OR], 1.91; CTA: 36.5% versus 8.4%, OR, 5.95;  P <0.001) and catheterization (stress: 5.5% versus 2.4%, OR, 2.36; CTA: 23.4% versus 4.1%, OR, 6.49;  P <0.001), and composite outcomes were higher for both inconclusive tests (stress: 3.7% versus 2.0%, hazard ratio, 1.81,  P =0.034; CTA: 5.0% versus 2.2%, hazard ratio, 1.85;  P =0.044) and positive tests (stress: 8.3% versus 2.0%, hazard ratio, 3.50; CTA: 9.2% versus 2.2%, hazard ratio, 3.66;  P <0.001). Twenty-four-month costs were higher for inconclusive tests than negative tests by $2905 (stress) and $4030 (CTA).
CONCLUSIONS


Among patients with stable chest pain undergoing a noninvasive test, inconclusive results occurred in 6% of CTA and 10% of stress tests. Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01174550.",2020,"Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes.","['Evaluation of Chest Pain', 'patients with stable chest pain undergoing a noninvasive test', 'patients with suspected coronary artery disease', 'Stable Patients With Suspected Coronary Artery Disease']",['stress testing (n=4533) or computed tomographic angiography (CTA'],"['composite outcomes', 'composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures', 'medical costs']","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0805463,"Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes.","[{'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'C Larry', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology, Tufts Medical Center, Boston, MA (J.E.U.).'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Department of Cardiology (M.H.P.), Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Pellikka', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.A.P.).'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Radiology (U.H.), Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}]",Circulation. Cardiovascular imaging,['10.1161/CIRCIMAGING.119.009986']
130,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
131,31229593,Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial.,"OBJECTIVES


The primary objective was to evaluate whether a molecular point-of-care test (POCT) for viral and atypical pathogens added to routine real-time PCR could reduce duration of intravenous antibiotics in hospitalized patients with lower respiratory tract infection (LRTI) compared with routine real-time PCR.
METHODS


In this single-centre, open-label, randomized controlled study, we enrolled hospitalized adults diagnosed with LRTI. Patients were randomized to an intervention group (POCT FilmArray Panel for 20 viruses, atypical pathogens and bacteria plus routine real-time PCR) or a control group (routine real-time PCR for ten pathogens). The primary outcome was duration of intravenous antibiotics during hospitalization. The secondary outcomes included length of stay, cost of hospitalization and de-escalation within 72 hours and between 72 hours and 7 days. Intention-to-treat analysis was used.
RESULTS


Between October 2017 and July 2018, we enrolled 800 eligible patients (398 in the intervention group and 402 in the control group). Duration of intravenous antibiotics in the intervention group was shorter than in the control (7.0 days (interquartile range (IQR) 5.0-9.0) versus 8.0 days (IQR 6.0-11.0); p <0.001). Length of hospital stay in the intervention group was significantly shorter (8.0 days (IQR 7.0-11.0) versus 9.0 days (IQR 7.0-12.0; p <0.001) and the cost of hospitalization in the intervention group was significantly lower ($1804.7 (IQR 1298.4-2633.8) versus $2042.5 (IQR 1427.4-2926.2); p 0.002) than control group. More patients in the intervention group achieved de-escalation within 72 hours (7.9%, 29/367 versus 3.2%, 12/377; p 0.005) and between 72 hours and 7 days (29.7%, 109/367 versus 22.0%, 83/377; p 0.024).
CONCLUSIONS


Use of molecular POCT testing for respiratory viruses and atypical pathogens might help to reduce intravenous antibiotic use in hospitalized LRTI patients.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03391076.",2019,"Length of hospital stay in the intervention group was significantly shorter (8.0 days [IQR, 7.0, 11.0]","['enrolled hospitalized adults diagnosed as LRTIs', 'hospitalized LRTI patients', 'Between October 2017 and July 2018', '800 eligible patients (398 in the intervention group and 402 in the control group', 'hospitalized patients with lower respiratory tract infection (LRTI', 'hospitalized adults with lower respiratory tract infection']","['care test (POCT', 'intervention group (POCT FilmArray Panel for 20 viral and atypical pathogens plus routine real-time PCR) or a control group (routine real-time PCR for 10 pathogens', 'intravenous antibiotic duration']","['duration of intravenous antibiotics during hospitalization', 'de-escalation', 'cost of hospitalization', 'Duration of intravenous antibiotic', 'length of stay, cost of hospitalization and de-escalation', 'Length of hospital stay']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",800.0,0.144005,"Length of hospital stay in the intervention group was significantly shorter (8.0 days [IQR, 7.0, 11.0]","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shengchen', 'Affiliation': 'Xuanwu Hospital of Capital Medical University, Beijing, China; Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': 'Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China; Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China; Clinical Centre for Pulmonary Infections, Capital Medical University, Beijing, China; Tsinghua University-Peking University Joint Centre for Life Sciences, Beijing, China. Electronic address: caobin_ben@163.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.06.012']
132,32316801,"A prospective, crossover randomized trial of the optimal timing for leucovorin rescue after high-dose methotrexate management in adult non-Hodgkin's lymphoma patients.","This study aimed to investigate the optimal time of leucovorin rescue for HDMTX in non-Hodgkin's lymphoma (NHL) patients. Ninety-eight patients treated with HDMTX were randomly assigned to receive leucovorin at either 18 or 24 h after initiation of HDMTX infusion during the first cycle and switched to the other mode in the second cycle. All courses achieved an efficacious MTX concentration. Compared to the 18th hour group, the 24th hour group exhibited an increase in incidence of thrombocytopenia (48% versus 34.7%,  p  = .036) and grade III/IV neutropenia (34.7% versus 21.4%,  p  = .039). No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups. We recommend that with the HDMTX generally used most adult patients with NHL may have greater therapeutic benefit and acceptable toxicity with their LV rescue started at 24 h instead of 18 h.",2020,No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups.,"['Ninety-eight patients treated with', ""non-Hodgkin's lymphoma (NHL) patients"", 'adult patients with NHL', ""adult non-Hodgkin's lymphoma patients""]","['HDMTX', 'leucovorin', 'HDMTX infusion', 'leucovorin rescue after high-dose methotrexate management', 'leucovorin rescue for HDMTX']","['grade III/IV neutropenia', 'incidence of thrombocytopenia', 'therapeutic benefit and acceptable toxicity', 'incidence of fever with grade III/IV neutropenia', 'bleeding', 'efficacious MTX concentration']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0244194,No bleeding occurred and the incidence of fever with grade III/IV neutropenia was low with no difference observed between the two groups.,"[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Tingzhi', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Huangming', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Quanguang', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1747061']
133,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


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


Medical research center.
METHODS


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


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


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


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


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
134,31490252,Fibrinogen Concentrate as an Alternative to Cryoprecipitate in a Postcardiopulmonary Transfusion Algorithm in Infants Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial.,"BACKGROUND


Infants undergoing cardiac surgery are at risk for bleeding and massive transfusion due to an immature coagulation system, complex surgeries, and cardiopulmonary bypass (CPB) effects. Hemodilution from CPB promotes an acquired hypofibrinogenemia that results in impaired fibrin formation, inadequate clot formation, and increased bleeding. In North America, the current standard of care to supplement fibrinogen is cryoprecipitate. An alternative option is the off-label use of fibrinogen concentrate (FC; RiaSTAP; CSL Behring, Marburg, Germany), a purified fibrinogen. Because perioperative allogenic transfusions are associated with increased morbidity and mortality, we sought to determine whether FC would be an acceptable alternative to cryoprecipitate in a post-CPB transfusion algorithm in infants undergoing open-heart surgery.
METHODS


We randomized 60 infants (<12 months) undergoing nonemergent cardiac surgery with CPB at 2 tertiary care children's hospitals to receive either cryoprecipitate or FC in a post-CPB transfusion algorithm. Infants underwent a stratified randomization based on institution and surgical complexity. The primary outcome was the difference in number of intraoperative allogenic blood product transfusions. Secondary outcomes included 24-hour chest tube output (CTO), mechanical ventilation time, adverse events (AEs), intensive care unit (ICU) length of stay (LOS), hospital LOS, postoperative thrombosis, and death within 30 days of surgery. The primary analysis followed the intent-to-treat (ITT) principle and was performed using linear regression adjusted for institution and complexity of surgery. A per-protocol (PP) analysis was also performed.
RESULTS


Between June 2016 and January 2018, we enrolled 60 patients with complete data available for 25 patients who received cryoprecipitate and 29 patients who received FC. Patients in the cryoprecipitate group (median age: 4 months [2-6 months]) received 5.5 (4.0-7.0) allogeneic blood units in the ITT analysis and 6.0 units (5.0-7.0 units) in the PP analysis. Patients in the FC group (median age: 4 months [2-5]) received 4 units (3.0-5.0 units) in the ITT analysis and 4.0 units (3.0-5.0 units) in the PP analysis. In the adjusted ITT analysis, the FC group received 1.79 units (95% confidence interval [CI], 0.64-2.93; P = .003) less than the cryoprecipitate group. In the adjusted PP analysis, the FC group received 2.67 units (95% CI, 1.75-3.59; P < .001) less than the cryoprecipitate group. There were no significant differences in secondary outcomes or AEs.
CONCLUSIONS


Our findings suggest that FC may be considered as an alternative to cryoprecipitate for the treatment of hypofibrinogenemia in infants with bleeding after CPB. Although we found no significant differences between secondary outcomes or AEs, further studies are needed to assess safety.",2020,"There were no significant differences in secondary outcomes or AEs.
","['infants undergoing open-heart surgery', 'Between June 2016 and January 2018, we enrolled 60 patients with complete data available for 25 patients who received cryoprecipitate and 29 patients who received', 'Infants undergoing cardiac surgery', 'infants with bleeding after CPB', 'Infants', 'Undergoing Cardiac Surgery', ""60 infants (<12 months) undergoing nonemergent cardiac surgery with CPB at 2 tertiary care children's hospitals to receive either""]","['cryoprecipitate or FC in a post-CPB transfusion algorithm', 'FC', 'Fibrinogen Concentrate']","['number of intraoperative allogenic blood product transfusions', 'secondary outcomes or AEs', '24-hour chest tube output (CTO), mechanical ventilation time, adverse events (AEs), intensive care unit (ICU) length of stay (LOS), hospital LOS, postoperative thrombosis, and death within 30 days of surgery', 'impaired fibrin formation, inadequate clot formation, and increased bleeding']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0919822', 'cui_str': 'Postoperative thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery (qualifier value)'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",60.0,0.356393,"There were no significant differences in secondary outcomes or AEs.
","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Departments of Pathology, Microbiology, and Immunology.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Department of Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kamra', 'Affiliation': ""Department of Anesthesiology, Stanford University School of Medicine, Lucile Packard Children's Hospital, Palo Alto, California.""}, {'ForeName': 'E Dean', 'Initials': 'ED', 'LastName': 'McKenzie', 'Affiliation': ""Division of Congenital Heart Surgery, Department of Surgery, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas.""}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Hanley', 'Affiliation': 'Departments of Cardiovascular Surgery.'}, {'ForeName': 'Glyn D', 'Initials': 'GD', 'LastName': 'Williams', 'Affiliation': ""Department of Anesthesiology, Stanford University School of Medicine, Lucile Packard Children's Hospital, Palo Alto, California.""}, {'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Guzzetta', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004384']
135,32325005,Home Monitoring in Patients with Idiopathic Pulmonary Fibrosis. A Randomized Controlled Trial.,"Rationale:  Idiopathic pulmonary fibrosis (IPF) is a deadly disease with increasingly impaired health-related quality of life (HRQOL). eHealth technologies facilitate collection of physiological outcomes and patient-reported outcomes at home, but randomized controlled trials (RCTs) on the effects of eHealth are scarce. Objectives:  To investigate whether a home monitoring program improves HRQOL and medication use for patients with IPF. Methods:  We performed a multicenter RCT in newly treated patients with IPF. Patients were randomly assigned to standard care or a home monitoring program on top of standard care for 24 weeks. The home monitoring program included home spirometry, reporting of symptoms and side effects, patient-reported outcomes, information, a medication coach, and eConsultations. The primary endpoint was between-group difference in change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score at 24 weeks. Measurements and Main Results:  A total of 90 patients were randomized (46 assigned to the home monitoring group and 44 to the standard care group). After 24 weeks, no statistically significant difference was found in K-BILD total score, with a 2.70-point increase in the home monitoring group (SD = 9.5) and a 0.03-point increase in the standard care group (SD = 10.4); between-group difference was 2.67 points (95% confidence interval [CI], -1.85 to 7.17;  P  = 0.24). Between-group difference in psychological domain score was 5.6 points (95% CI, -1.13 to 12.3;  P  = 0.10), with an increase of 5.12 points in the home monitoring group (SD = 15.8) and a decline of 0.48 points in the standard care group (SD = 13.3). In the home monitoring group, medication was more often adjusted (1 vs. 0.3 adjustments per patient; 95% CI, 0.2 to 1.3;  P  = 0.027). Patient satisfaction with the home monitoring program was high. Home-based spirometry was highly correlated with hospital-based spirometry over time. Conclusions:  The results of this first-ever eHealth RCT in IPF showed that a comprehensive home monitoring program did not improve overall HRQOL measured with K-BILD but tended to improve psychological well-being. Home monitoring was greatly appreciated by patients and allowed for individually tailored medication adjustments.Clinical trial registered with www.clinicaltrials.gov (NCT03420235).",2020,"After 24 weeks, no statistically significant differences were found in K-BILD total score (home monitoring group:+2.7 points, standard care:+0.03, p=0.24) and psychological domain score (home monitoring group:+5.1, standard care:-0.5, p=0.1).","['IPF patients', '90 patients were randomized (46 patients home monitoring, 44 standard care', 'Patients with Idiopathic Pulmonary Fibrosis', 'Idiopathic pulmonary fibrosis (IPF', 'newly treated patients with IPF']",['standard care or a home monitoring program'],"['psychological domain score', 'change in Kings Brief Interstitial Lung disease (K-BILD) questionnaire score', 'psychological wellbeing', 'home spirometry, reporting of symptoms and side-effects, PROMs, information, a medication coach and eConsultations', 'overall HRQOL', 'K-BILD total score']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",90.0,0.0641793,"After 24 weeks, no statistically significant differences were found in K-BILD total score (home monitoring group:+2.7 points, standard care:+0.03, p=0.24) and psychological domain score (home monitoring group:+5.1, standard care:-0.5, p=0.1).","[{'ForeName': 'Catharina C', 'Initials': 'CC', 'LastName': 'Moor', 'Affiliation': 'Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Rémy L M', 'Initials': 'RLM', 'LastName': 'Mostard', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland Medical, Heerlen, the Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Grutters', 'Affiliation': 'Department of Pulmonology, Interstitial Lung Diseases Centre of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Respiratory Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; and.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, National eHealth Living Lab, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202002-0328OC']
136,32313451,Latiglutenase Treatment for Celiac Disease: Symptom and Quality of Life Improvement for Seropositive Patients on a Gluten-Free Diet.,"Background


Celiac disease (CD) is a widespread autoimmune disease triggered by dietary gluten that can lead to severe gastrointestinal symptoms. Because there is no available treatment other than a lifelong gluten-free diet, many patients continue to experience chronic symptoms.
Aim


In this analysis we report on the efficacy of latiglutenase, an orally administered enzyme treatment, for improving multiple gluten-induced symptoms and consequent quality of life (QOL) due to inadvertent gluten consumption.
Methods


This analysis is based on data from the CeliAction study of symptomatic patients (ALV003-1221; NCT01917630). Patients were treated with latiglutenase or placebo for 12 weeks and instructed to respond to a symptom diary daily and to multiple QOL questionnaires at weeks 0, 6, and 12 of the treatment periods as secondary endpoints. The results were stratified by serostatus.
Results


398 patients completed the 12-week CDSD study. In seropositive, but not seronegative, CD patients a statistically significant and dose-dependent improvement was seen in the severity and frequency of abdominal pain, bloating, tiredness, and constipation. In subjects receiving 900 mg latiglutenase, improvements (p-values) in the severity of these symptoms for week 12 were 58% (0.038), 44% (0.023), 21% (0.164), and 104% (0.049) respectively, relative to placebo-dosed subjects. The reduction in symptoms trended higher for more symptomatic patients. Similar results were observed for the QOL outcome measures.
Conclusions


Although this study was not powered to definitively establish the benefit of latiglutenase in seropositive CD patients, such patients appear to show symptomatic and QOL benefit from using latiglutenase with meals.",2019,"In seropositive, but not seronegative, CD patients a statistically significant and dose-dependent improvement was seen in the severity and frequency of abdominal pain, bloating, tiredness, and constipation.","['Seropositive Patients on a Gluten-Free Diet', '398 patients completed the 12-week CDSD study', 'seropositive CD patients']",['latiglutenase or placebo'],"['severity and frequency of abdominal pain, bloating, tiredness, and constipation', 'QOL outcome measures', 'multiple gluten-induced symptoms and consequent quality of life (QOL']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0309713,"In seropositive, but not seronegative, CD patients a statistically significant and dose-dependent improvement was seen in the severity and frequency of abdominal pain, bloating, tiredness, and constipation.","[{'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Syage', 'Affiliation': 'ImmunogenX, Newport Beach, CA, United States.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Celiac Disease Center, Columbia University, New York, NY, United States.'}, {'ForeName': 'Chaitan', 'Initials': 'C', 'LastName': 'Khosla', 'Affiliation': 'Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Adelman', 'Affiliation': 'Aimmune Therapeutics, Brisbane, CA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Sealey-Voyksner', 'Affiliation': 'ImmunogenX, Newport Beach, CA, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}]",GastroHep,['10.1002/ygh2.371']
137,31589137,An Integrative Evaluation of the Efficacy of a Directional Microphone and Noise-Reduction Algorithm under Realistic Signal-to-Noise Ratios.,"BACKGROUND


Many studies on the efficacy of directional microphones (DIRMs) and noise-reduction (NR) algorithms were not conducted under realistic signal-to-noise ratio (SNR) conditions. A Repeat-Recall Test (RRT) was developed previously to partially address this issue.
PURPOSE


This study evaluated whether the RRT could provide a more comprehensive understanding of the efficacy of a DIRM and NR algorithm under realistic SNRs. Possible interaction with listener working memory capacity (WMC) was assessed.
RESEARCH DESIGN


This study uses a double-blind, within-subject repeated measures design.
STUDY SAMPLE


Nineteen listeners with a moderate degree of hearing loss participated.
DATA COLLECTION AND ANALYSIS


The RRT was administered with participants wearing the study hearing aids (HAs) under two microphones (omnidirectional versus directional) by two NR (on versus off) conditions. Speech was presented from 0° at 75 dB SPL and a continuous noise from 180° at SNRs of 0, 5, 10, and 15 dB. The order of SNR and HA conditions was counterbalanced across listeners. Each test condition was completed twice in two 2-hour sessions separated by one month.
RESULTS


The recall scores of listeners were used to group listeners into good and poor WMC groups. Analysis using linear mixed-effects models revealed significant effects of context, SNR, and microphone for all four measures (repeat, recall, listening effort, and tolerable time). NR was only significant on the listening effort scale in the DIRM mode at an SNR of 5 dB. Listeners with good WMC performed better on all measures of the RRT and benefitted more from context. Although DIRM benefitted listeners with good and poor WMC, the benefits differed by context and SNR.
CONCLUSIONS


The RRT confirmed the efficacy of DIRM and NR on several outcome measures under realistic SNRs. It also highlighted interactions between WMC and sentence context on feature efficacy.",2020,NR was only significant on the listening effort scale in the DIRM mode at an SNR of 5 dB. Listeners with good WMC performed better on all measures of the RRT and benefitted more from context.,['Nineteen listeners with a moderate degree of hearing loss participated'],"['Repeat-Recall Test (RRT', 'RRT', 'directional microphones (DIRMs) and noise reduction (NR', 'listener working memory capacity (WMC', 'participants wearing the study hearing aids (HAs) under two microphones (omnidirectional versus directional) by two NR', 'Directional Microphone and Noise Reduction Algorithm under Realistic Signal-to-Noise Ratios']","['context, SNR, and microphone for all four measures (repeat, recall, listening effort, and tolerable time', 'listening effort scale', 'recall scores of listeners']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0002045'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]","[{'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0188878,NR was only significant on the listening effort scale in the DIRM mode at an SNR of 5 dB. Listeners with good WMC performed better on all measures of the RRT and benefitted more from context.,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Kuk', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, IL.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slugocki', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, IL.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, IL.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.19009']
138,32219386,Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes.,"Importance


Additional treatments are needed for heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be an effective treatment for patients with HFrEF, even those without diabetes.
Objective


To evaluate the effects of dapagliflozin in patients with HFrEF with and without diabetes.
Design, Setting, and Participants


Exploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries. Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019.
Interventions


Addition of once-daily 10 mg of dapagliflozin or placebo to recommended therapy.
Main Outcomes and Measures


The primary outcome was the composite of an episode of worsening heart failure or cardiovascular death. This outcome was analyzed by baseline diabetes status and, in patients without diabetes, by glycated hemoglobin level less than 5.7% vs greater than or equal to 5.7%.
Results


Among 4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial. Among participants without diabetes, the primary outcome occurred in 171 of 1298 (13.2%) in the dapagliflozin group and 231 of 1307 (17.7%) in the placebo group (hazard ratio, 0.73 [95% CI, 0.60-0.88]). In patients with diabetes, the primary outcome occurred in 215 of 1075 (20.0%) in the dapagliflozin group and 271 of 1064 (25.5%) in the placebo group (hazard ratio, 0.75 [95% CI, 0.63-0.90]) (P value for interaction = .80). Among patients without diabetes and a glycated hemoglobin level less than 5.7%, the primary outcome occurred in 53 of 438 patients (12.1%) in the dapagliflozin group and 71 of 419 (16.9%) in the placebo group (hazard ratio, 0.67 [95% CI, 0.47-0.96]). In patients with a glycated hemoglobin of at least 5.7%, the primary outcome occurred in 118 of 860 patients (13.7%) in the dapagliflozin group and 160 of 888 (18.0%) in the placebo group (hazard ratio, 0.74 [95% CI, 0.59-0.94]) (P value for interaction = .72). Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes. A kidney adverse event was reported in 4.8% of patients in the dapagliflozin group and 6.0% in the placebo group among patients without diabetes and in 8.5% of patients in the dapagliflozin group and 8.7% in the placebo group among patients with diabetes.
Conclusions and Relevance


In this exploratory analysis of a randomized trial of patients with HFrEF, dapagliflozin compared with placebo, when added to recommended therapy, significantly reduced the risk of worsening heart failure or cardiovascular death independently of diabetes status.
Trial Registration


ClinicalTrials.gov Identifier: NCT03036124.",2020,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"['than 5.7% vs greater than or equal to 5.7', 'Patients With Heart Failure', '4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial', 'patients with', 'Participants\n\n\nExploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries', 'patients with HFrEF with and without diabetes', 'patients with HFrEF, even those without diabetes', 'Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019']","['HFrEF, dapagliflozin', 'Dapagliflozin', 'placebo', 'dapagliflozin or placebo', 'dapagliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors']","['glycated hemoglobin', 'adverse event', 'glycated hemoglobin level less', 'kidney adverse event', 'risk of worsening heart failure or cardiovascular death independently of diabetes status', 'composite of an episode of worsening heart failure or cardiovascular death', 'Volume depletion', 'glycated hemoglobin level', 'Worsening Heart Failure and Cardiovascular Death']","[{'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}]",4744.0,0.292236,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlávek', 'Affiliation': 'Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, Haryana, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Fifth Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Disease, Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Institute of Medicine, Department of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Ontario, Canada.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Discovery and Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",JAMA,['10.1001/jama.2020.1906']
139,32162970,Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease.,"Rationale:  The IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial demonstrated a significant reduction in all-cause mortality (ACM) risk with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) at risk of future exacerbations. Five hundred seventy-four patients were censored in the original analysis owing to incomplete vital status information. Objectives:  Report ACM and impact of stepping down therapy, following collection of additional vital status data. Methods:  Patients were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg following a run-in on their COPD therapies. Time to ACM was prespecified. Additional vital status data collection and subsequent analyses were performed  post hoc . Measurements and Main Results:  We report vital status data for 99.6% of the intention-to-treat population ( n  = 10,355), documenting 98 (2.36%) deaths on FF/UMEC/VI, 109 (2.64%) on FF/VI, and 66 (3.19%) on UMEC/VI. For FF/UMEC/VI, the hazard ratio for death was 0.72 (95% confidence interval, 0.53-0.99;  P  = 0.042) versus UMEC/VI and 0.89 (95% confidence interval, 0.67-1.16;  P  = 0.387) versus FF/VI. Independent adjudication confirmed lower rates of cardiovascular and respiratory death and death associated with the patient's COPD. Conclusions:  In this secondary analysis of an efficacy outcome from the IMPACT trial, once-daily single-inhaler FF/UMEC/VI triple therapy reduced the risk of ACM versus UMEC/VI in patients with symptomatic COPD and a history of exacerbations.",2020,"For FF/UMEC/VI, the hazard ratio for death was 0.72","['patients with symptomatic COPD and a history of exacerbations', 'Patients', 'COPD Patients', 'patients with COPD at risk of future exacerbations']","['Fluticasone Furoate/Umeclidinium/Vilanterol', 'FF/UMEC/VI 100/62.5/25', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI']","['hazard ratio for death', 'rates of cardiovascular and respiratory death, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.617718,"For FF/UMEC/VI, the hazard ratio for death was 0.72","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'Safety and Medical Governance and.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, R&D, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Manchester', 'Affiliation': 'Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Midwinter', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pascoe', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2207OC']
140,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION


The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy.
METHODS


Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed.
RESULTS


From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]).
CONCLUSIONS


Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083']
141,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245)  = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9']
142,32320088,"Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies.","BACKGROUND


Risankizumab is a humanized IgG monoclonal antibody that selectively inhibits interleukin-23 through binding the p19 subunit. In Phase 3 trials, risankizumab demonstrated superior efficacy compared with adalimumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. Here, we evaluated the impact of baseline characteristics on efficacy of risankizumab compared with ustekinumab in patients with moderate-to-severe plaque psoriasis.
METHODS


This analysis included all patients initially randomized to risankizumab or ustekinumab from the replicate, double-blinded, randomized, placebo-controlled phase 3 trials, UltIMMa-1 (NCT02684370) and UltIMMa-2 (NCT02684357). Patients received either risankizumab (150 mg) or ustekinumab (weight-based; 45 or 90 mg per label) at weeks 0, 4, 16, 28 and 40. Efficacy was assessed as the proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at weeks 16 and 52 by baseline patient demographics, disease characteristics and prior biologic exposure. Mean per cent improvement in PASI was calculated by body weight and body mass index at week 52. Missing efficacy data were imputed as non-responders for categorical variables and last observation carried forward for continuous variables. Logistic regression analyses assessed for interactions between treatment and five independent variables (age, sex, weight, baseline PASI score and presence of psoriatic arthritis) at both weeks 16 and 52.
RESULTS


Baseline patient demographics, disease characteristics and prior biologic exposure were similar between patients randomized to risankizumab (n = 598) and ustekinumab (n = 199). At weeks 16 and 52, risankizumab demonstrated superior efficacy compared with ustekinumab across these patient characteristics (P < 0.01). Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001 for all).
CONCLUSIONS


Risankizumab demonstrated consistent and superior efficacy compared with ustekinumab regardless of patient demographics, disease characteristics or prior biologic exposure.",2020,"Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P<0.0001 for all).
","['patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis by Baseline Demographics, Disease Characteristics and Prior Biologic Therapy']","['adalimumab and ustekinumab', 'ustekinumab', 'Risankizumab', 'placebo', 'risankizumab', 'risankizumab or ustekinumab']","['PASI', 'Psoriasis Area and Severity Index', 'Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.135887,"Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P<0.0001 for all).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Baylor Scott and White, Dallas, TX, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, Richmond Heights, MO, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Photowala', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Longcore', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhan', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne, Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16521']
143,30580089,Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-Control Treatment in Adults With Fecal Incontinence.,"BACKGROUND & AIMS


Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence.
METHODS


We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient Global Impression of Improvement scale. Secondary outcomes were changes in the Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale.
RESULTS


In the intention-to-treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms based on Patient Global Impression of Improvement scale scores (unadjusted odds ratio, 5.16; 95% CI, 2.18-12.19; P = .0002). The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, -3.57 to -0.08; P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported.
CONCLUSIONS


This randomized controlled trial of adults with fecal incontinence provides support for a superior effect of supervised PFMT in combination with conservative treatment compared with attention-control massage treatment and conservative treatment. We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity based on the Vaizey Score compared with attention control massage treatment. Clinicaltrials.gov no: NCT01705535.",2019,"The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, -3.57 to -0.08; P = .04).","['Adults With Fecal Incontinence', 'patients with fecal incontinence', 'adults with fecal incontinence', 'Ninety-eight adults with fecal incontinence', 'patients with fecal incontinence at a tertiary care center at a public hospital in Denmark']","['supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment', 'supervised PFMT', 'Supervised Pelvic Floor Muscle Training and Biofeedback Vs Attention-Control Treatment', 'Pelvic floor muscle training (PFMT', 'PFMT']","['fecal incontinence symptoms', 'adverse events', 'incontinence symptoms based on Patient Global Impression of Improvement scale scores', 'rating of symptom changes', 'mean Vaizey Score', 'superiority of PFMT', 'Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale', 'condition-specific quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}]",98.0,0.142424,"The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, -3.57 to -0.08; P = .04).","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ussing', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev, Denmark; Optimed, Clinical Research Centre, Herlev, Denmark. Electronic address: anja.ussing@regionh.dk.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Dahn', 'Affiliation': 'Department of Surgical and Medical Gastroenterology, Herlev, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Due', 'Affiliation': 'Department of Obstetrics and Gynaecology, Herlev, Denmark; Department of Occupational and Physical Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Department of Surgical and Medical Gastroenterology, Herlev, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Optimed, Clinical Research Centre, Herlev, Denmark; Section of Biostatistics, Department of Public Health, Herlev, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev, Denmark; Optimed, Clinical Research Centre, Herlev, Denmark; Physical Medicine and Rehabilitation Research-Copenhagen, Copenhagen University Hospital, Hvidovre, Denmark.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.12.015']
144,30503967,Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples.,"BACKGROUND & AIMS


The fecal immunochemical test (FIT) is an alternative to colonoscopy and can increase overall screening for colorectal cancer (CRC). However, little is known about the frequency of and reasons for mishandled FIT samples.
METHODS


We performed a prospective study, nested within a randomized controlled trial of patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old). The patients were randomly assigned to usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both. We examined frequency of and reasons for mishandled FIT samples, including absence of collection date; time from collection to laboratory receipt of more than 14 days; or mishandling of stool, buffer, or cap. The outcomes were the frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples.
RESULTS


FIT samples were returned from 1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call. In total, 19.8% of samples were mishandled; most of these (93.7%) had not labeled the date of stool collection but were still processed. Of the received samples, 1.2% of were not processed because the time from patient collection to laboratory receipt was more than 14 days. Outreach was associated with a lower proportion of mishandled samples (16.5% vs 25.0% for usual care; P < .0001). The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001). There was no significant difference in proportions of positive results between properly processed samples (7.5%) and improperly processed samples (6.2%) (P = .14).
CONCLUSION


In a prospective study of patients who were not up to date with colorectal cancer screening, we found that almost 20% of FIT samples were mishandled, with most patients missing the stool collection date. Patient outreach was associated with a lower proportion of mishandled samples, but there was no difference in proportions of positive results between properly and improperly handled samples. Our findings indicate that routine processing of undated FIT samples is associated with similar rates of positive results. There are limited data on test characteristics for FIT samples beyond the 14 days of stool acquisition. The inclusion of low literacy level instructions with reminder calls was associated with improved patient handling of the FIT sample. ClincialTrials.gov no: NCT02613260.",2019,"The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001).","['1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call', 'patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old', 'patients who were not up to date with colorectal cancer screening']","['usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both']","['proportion of mishandled samples', 'fecal immunochemical test (FIT', 'proportions of positive results', 'frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0960817,"The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Graduate Division, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research and Public Health Science Divisions, Fred Hutchinson, Seattle, Washington; Division of Gastroenterology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California, San Francisco, San Francisco, California; Center for Vulnerable Populations, University of California, San Francisco, San Francisco, California. Electronic address: ma.somsouk@ucsf.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.050']
145,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B  receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B  receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7']
146,31641058,Communicating risk differences between electronic and combusted cigarettes: the role of the FDA-mandated addiction warning and a nicotine fact sheet.,"INTRODUCTION


The US Food and Drug Administration requires e-cigarettes to carry a nicotine addiction warning. This research compared the effects of messages communicating comparative risk of electronic and combusted cigarettes (CR messages) with and without the mandated warning and tested the effects of showing a nicotine fact sheet (NFS) before exposure to CR messages with warning.
METHOD


In an online experiment, 1528 US adult smokers were randomised to one of four conditions: (1) three CR messages, (2) three CR messages in condition one with an addiction warning, (3) an NFS followed by the three messages in condition 2 and (4) control messages. Outcomes included message reactions and perceived effectiveness, e-cigarette-related and cigarette-related beliefs and behavioural intentions and nicotine-related beliefs.
RESULTS


CR messages with and without an addiction warning did not differ. The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments. Compared with control, all messages made it more likely for people to report e-cigarettes are less harmful than cigarettes and increased response efficacy and switch intentions to e-cigarettes. Only NFS condition increased correct beliefs about the risk of nicotine and self-efficacy about switching to e-cigarettes.
CONCLUSION


Including an addiction warning on CR messages did not reduce intentions to switch to e-cigarettes. Communicating accurate risk of nicotine together with CR messages and addiction warning increased smokers' self-efficacy beliefs about switching completely to e-cigarettes, making it a potentially promising antitobacco communication strategy.",2020,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,['1528 US adult smokers'],"['CR messages, (2) three CR messages in condition one with an addiction warning, (3) an NFS followed by the three messages in condition 2 and (4) control messages', 'electronic and combusted cigarettes', 'electronic and combusted cigarettes (CR messages', 'nicotine fact sheet (NFS']","['message reactions and perceived effectiveness, e-cigarette-related and cigarette-related beliefs and behavioural intentions and nicotine-related beliefs', ""smokers' self-efficacy beliefs"", 'health risks (response efficacy', 'correct beliefs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.0238373,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA lpopova1@gsu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055204']
147,32321085,"Effectiveness of mindfulness-integrated cognitive behavior therapy on anxiety, depression and hope in multiple sclerosis patients: a randomized clinical trial.","INTRODUCTION


Multiple sclerosis (MS) is a chronic medical condition that attracts particular attention because of the high risks associated with it. MS patients suffer from medical problems, depression, anxiety, and reduced hopefulness. These issues can increase the severity of the disease and treatment resistance and reduce patients' individual and social efficacy. Mindfulness-integrated cognitive behavior therapy (MICBT) is a new approach that is being applied in chronic diseases and can be used in combination with existing treatments. Therefore, the present study investigated the efficacy of MICBT in terms of anxiety, depression, and hope in MS patients.
METHODS


A sample of 20 patients with MS was randomly selected at Shafa Hospital in Kerman City, Iran. Patients were then assigned to one of two groups of 10 people using a random number table. The experimental group received MICBT. The control group also received the same therapy after study completion. The assessment tools used in this study included the Beck Depression Inventory-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), and Miller Hope Scale (MHS). Measurements were conducted at three stages: pre-test, post-test, and follow-up. For data analysis, means and standard deviations were calculated and one-way analysis of covariance was conducted using SPSS 24.
RESULTS


Compared with controls, MICBT was effective for reducing depression (P < 0.001, F = 72.55), anxiety (P < 0.001, F = 100.75). Additionally, MICBT was effective in improving hope (P < 0.001, F = 45.36). Changes were maintained in the follow-up phase.
CONCLUSION


The MICBT affects depression, anxiety and hope of MS patients. Therefore, mental health professionals can benefit from the results obtained in the present study to reduce depression and anxiety and increase hope in this group of patients.
CLINICAL TRIAL REGISTRATION


Iranian Registry of Clinical Trials, IRCT201601030258N4.",2020,"Additionally, MICBT was effective in improving hope (P < 0.001, F = 45.36).","['20 patients with MS was randomly selected at Shafa Hospital in Kerman City, Iran', 'multiple sclerosis patients']","['mindfulness-integrated cognitive behavior therapy', 'Mindfulness-integrated cognitive behavior therapy (MICBT', 'MICBT']","['anxiety, depression and hope', 'depression', 'Beck Depression Inventory-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), and Miller Hope Scale (MHS', 'anxiety', 'depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.026418,"Additionally, MICBT was effective in improving hope (P < 0.001, F = 45.36).","[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Pouyanfard', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mohammadpour', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'ParviziFard', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kheirollah', 'Initials': 'K', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Trends in psychiatry and psychotherapy,['10.1590/2237-6089-2018-0105']
148,32319233,"A phase II, randomized study of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study.","BACKGROUND


In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence.
METHODS


SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography-computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cycles of platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03983226.",2020,"Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open.","['OC patients with secondary recurrence', '96 patients', 'platinum-sensitive, secondary recurrent ovarian cancer', 'Eligible patients', 'patients with platinum-sensitive second relapsed OC who never received SCR at recurrence', 'Patients who undergo at least 4 cycles of']","['cytoreductive surgery (SCR', 'chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance', 'chemotherapy', 'SCR followed by 6 cycles of platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone', 'cytoreductive surgery combined with niraparib maintenance']","['overall survival benefit', '12-month non-progression rate']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0939351,"Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open.","[{'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. tyshi80@163.com.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xipeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yincheng', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': ""Department of Gynecology and Obstetrics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yingli', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Ai', 'Affiliation': ""Department of Gynecology and Obstetrics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University, Shanghai, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Clinical Statistics Center, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e61']
149,32283407,Noradrenergic system and cognitive flexibility: Disentangling the effects of depression and childhood trauma.,"Stress plays a fundamental role in the development and maintenance of major depressive disorder (MDD). Importantly, maladaptive changes in the physiological stress regulation systems have been demonstrated. In the locus coeruleus-noradrenergic (LC-NA) system, up-regulated central alpha2-adrenergic receptors in patients with MDD affect cognitive functions. Although cognitive deficits are core symptoms of MDD, the relationship between the LC-NA system and cognitive processes has rarely been investigated in depressed patients. The aim of our study was to investigate whether noradrenergic stimulation affects cognitive flexibility in MDD. In addition, we aimed to further disentangle the effects of MDD and adverse childhood experiences (ACE), such as physical or sexual abuse on cognitive function. In a double-blind placebo-controlled study, MDD patients with ACE, MDD patients without ACE, healthy participants with ACE and healthy control participants without MDD or ACE were tested with a task switching task (total N = 125). Participants were tested twice after treatment with either 10 mg yohimbine or a placebo. Switch costs (differences between switch and repetition trials) in reaction times and accuracy served as the independent variables. We found higher switch costs in MDD patients as compared with controls, while ACE did not affect task performance. Yohimbine administration had no effect on task switching. The results of this study contribute to a better understanding of the role of the LC-NA system as a neurobiological mechanism of cognitive processes in patients with MDD.",2020,Yohimbine administration had no effect on task switching.,"['patients with MDD', 'MDD patients with ACE, MDD patients without ACE, healthy participants with ACE and healthy control participants without MDD or ACE']","['Yohimbine', 'yohimbine', 'noradrenergic stimulation', 'placebo']","['switch costs', 'Noradrenergic system and cognitive flexibility', 'task switching']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",125.0,0.0354099,Yohimbine administration had no effect on task switching.,"[{'ForeName': 'Christian Eric', 'Initials': 'CE', 'LastName': 'Deuter', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany. Electronic address: christian.deuter@charite.de.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bustami', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Linn Kristina', 'Initials': 'LK', 'LastName': 'Kuehl', 'Affiliation': 'Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.03.017']
150,32286882,HDL-apoA-I kinetics in response to 16 wk of exercise training in men with nonalcoholic fatty liver disease.,"Nonalcoholic fatty liver disease (NAFLD) is characterized by low-circulating concentration of high-density lipoprotein cholesterol (HDL-C) and raised triacylglycerol (TAG). Exercise reduces hepatic fat content, improves insulin resistance and increases clearance of very-low-density lipoprotein-1 (VLDL 1 ). However, the effect of exercise on TAG and HDL-C metabolism is unknown. We randomized male participants to 16 wk of supervised, moderate-intensity aerobic exercise ( n  = 15), or conventional lifestyle advice ( n  = 12). Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics were investigated using stable isotopes (1-[ 13 C]-leucine and 1,1,2,3,3- 2 H 5  glycerol) pre- and postintervention. Participants underwent MRI/spectroscopy to assess changes in visceral fat. Results are means ± SD. At baseline, there were no differences between exercise and control groups for age (52.4 ± 7.5 vs. 52.8 ± 10.3 yr), body mass index (BMI: 31.6 ± 3.2 vs. 31.7 ± 3.6 kg/m 2 ), and waist circumference (109.3 ± 7.5 vs. 110.0 ± 13.6 cm). Percentage of liver fat was 23.8 (interquartile range 9.8-32.5%). Exercise reduced body weight (101.3 ± 10.2 to 97.9 ± 12.2 kg;  P  < 0.001) and hepatic fat content [from 19.6%, interquartile range (IQR) 14.6-36.1% to 8.9% (4.4-17.8%);  P  = 0.001] and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group. However, plasma and VLDL 1 -TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR) did not change significantly with exercise. Both at baseline (all participants) and after exercise there was an inverse correlation between apoA-I pool size and VLDL-TAG and -apoB pool size. The modest effect of exercise on HDL metabolism may be explained by the lack of effect on plasma and VLDL 1 -TAG.",2020,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","['male participants to 16 weeks of', 'men with non-alcoholic fatty liver disease (NAFLD']","['MRI/spectroscopy', 'exercise training', 'supervised, moderate-intensity aerobic exercise (n=15) or conventional lifestyle advice']","['Exercise reduced body weight', 'visceral fat', 'hepatic fat content', 'BMI', 'Percentage liver fat', 'waist circumference', 'hepatic fat content, improves insulin resistance and increases clearance of very-low density lipoprotein-1 (VLDL1', 'Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics', 'fraction HDL-C concentration', 'plasma and VLDL1 TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",,0.147255,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Whyte', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shojaee-Moradie', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Sharaf E', 'Initials': 'SE', 'LastName': 'Sharaf', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cuthbertson', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Jackson', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Roselle A', 'Initials': 'RA', 'LastName': 'Herring', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Thomas', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'A Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00019.2020']
151,32314970,Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.,"BACKGROUND


The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings.
OBJECTIVE


This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study.
METHODS


Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attempted to contact the 212 individuals originally enrolled in the study in Peru. The primary outcomes were systolic and diastolic blood pressure levels and hypertension incidence. Secondary outcome measures were body weight, BMI, and self-reported target behaviors. The study personnel collecting the data were masked to the group assignment. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes in an intention-to-treat analysis.
RESULTS


Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group). The intervention did not result in changes in systolic (-2.54 mm Hg, 95% CI -8.23 to 3.15) or diastolic (3.41 mm Hg, 95% CI -0.75 to 7.57) blood pressure compared with the control group. The intervention reduced the risk of developing hypertension, but the result was not significant (risk ratio (RR) 0.76, 95% CI 0.45-1.28). However, those who received the intervention had lower body weight (-5.42 kg, 95% CI -10.4 to -0.48) and BMI (-2.56 kg/m2, 95% CI -4.46 to -0.66). In addition, compared to the control participants, those who received ≥50% of the scheduled calls during the intervention had greater reductions in body weight (-6.23 kg, 95% CI -11.47 to -0.99) and BMI (-2.81 kg/m2, 95% CI -4.77 to -0.85).
CONCLUSIONS


An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion. Although there were no effects on blood pressure levels, important reductions in body weight and BMI were seen 5 years after randomization. Thus, mHealth appears to be a promising preventive strategy for noncommunicable diseases in resource-constrained settings.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216.",2020,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"['212 individuals originally enrolled in the study in Peru', 'Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group', 'low-resource urban settings in Peru, 4 years after the completion of the original study']","['mobile health (mHealth) interventions', 'motivational interview calls and SMS text messaging', 'mHealth intervention']","['body weight', 'blood pressure', 'body weight, BMI, and self-reported target behaviors', 'changes in systolic', 'Cardiometabolic Risk Factors', 'BMI', 'risk of developing hypertension', 'body weight and BMI', 'diastolic', 'systolic and diastolic blood pressure levels and hypertension incidence', 'blood pressure levels and body weight', 'blood pressure levels', 'lower body weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205313', 'cui_str': 'Original'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",212.0,0.145874,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pauschardt', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Journal of medical Internet research,['10.2196/14595']
152,32314971,Evaluating an Intervention Program Using WeChat for Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.,"BACKGROUND


The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.
OBJECTIVE


This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.
METHODS


The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).
RESULTS


The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.
CONCLUSIONS


The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3.",2020,"No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency.","['patients with chronic obstructive pulmonary disease (COPD', '94 participants completed the 6-month pulmonary rehabilitation program', '106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF', 'Patients With Chronic Obstructive Pulmonary Disease', 'patients with COPD']","['telemedicine', 'Intervention Program Using WeChat', 'Pulmonary rehabilitation intervention', 'WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR']","['mMRC scores', ""modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ"", 'sense of self-efficacy and quality of life and alleviate symptoms', 'CAT', 'CAT score', 'Ex-SRES', 'patient quality of life measured with the COPD assessment test (CAT', 'self-efficacy', 'quality of life, symptoms, and exercise self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",106.0,0.0856027,"No statistically significant differences were observed in CAT (F 1,3 =7.78, P=.001), Ex-SRES (F 1,3 =21.91, P<.001), and mMRC scores (F 1,3 =29.64, P<.001) between the two groups with the variation in time tendency.","[{'ForeName': 'Yuyu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Fenglan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Wuxi School of Medicine, Jiangnan University, Wuxi, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Hongqing', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Wuxi Second People's Hospital, Wuxi, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Wuxi Second Hospital of Traditional Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Zhaosheng', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Rongjun Hospital of Jiangsu Province, Wuxi, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Huishan District Rehabilitation Hospital, Wuxi, China.'}]",Journal of medical Internet research,['10.2196/17089']
153,32316886,Efficacy of Cognitive Behavioral Treatment for Insomnia: A Randomized Controlled Trial.,"This study examined the effects of cognitive behavioral treatment for insomnia. A randomized controlled trial was performed on 44 women. The intervention included one group session of sleep hygiene education and four individual sessions of counseling. The instruments included the Insomnia Severity Index, Pittsburgh Sleep Quality Index, the Center for Epidemiological Studies Depression Scale, and Menopausal quality of life. The data were analyzed using repeated measure MANOVA, followed by repeated measure ANOVA. Repeated measure MANOVA showed that time had a significant main effect on the anthropometric variables (body mass index, waist circumference, and blood pressures) and revealed significant main effects of the group and time on the psychosocial variables (sleep quality, insomnia, depressive symptoms, and quality of life) ( p  < .05). Repeated measure ANOVA results indicated a significant effect of the group on insomnia and sleep quality ( p  < .05). Overall, the intervention was effective in improving insomnia and poor sleep quality.",2020,Repeated measure ANOVA results indicated a significant effect of the group on insomnia and sleep quality ( p  < .05).,"['44 women', 'Insomnia', 'insomnia']","['Cognitive Behavioral Treatment', 'sleep hygiene education and four individual sessions of counseling', 'cognitive behavioral treatment']","['Insomnia Severity Index, Pittsburgh Sleep Quality Index, the Center for Epidemiological Studies Depression Scale, and Menopausal quality of life', 'anthropometric variables (body mass index, waist circumference, and blood pressures', 'insomnia and sleep quality', 'psychosocial variables (sleep quality, insomnia, depressive symptoms, and quality of life', 'insomnia and poor sleep quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",44.0,0.0326915,Repeated measure ANOVA results indicated a significant effect of the group on insomnia and sleep quality ( p  < .05).,"[{'ForeName': 'Ok Kyung', 'Initials': 'OK', 'LastName': 'Ham', 'Affiliation': 'Department of Nursing, Inha University, Incheon, Republic of Korea.'}, {'ForeName': 'Bo Gyeong', 'Initials': 'BG', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Graduate School of Clinical Nursing Science, Samsung Medical Center, Sungkyunkwan University, Suwon, Republic of Korea.'}]",Western journal of nursing research,['10.1177/0193945920914081']
154,30448598,Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infection.,"BACKGROUND & AIMS


Besifovir dipivoxil maleate (BSV) has activity against hepatitis B virus (HBV). We performed a phase 3 study to compare the antiviral efficacy and safety of BSV vs tenofovir disoproxil fumarate (TDF) in patients with chronic HBV infection in Korea.
METHODS


We conducted a double-blind, non-inferiority trial of 197 patients with chronic HBV infection at 22 sites in South Korea, from November 2013 through February 2016. Patients were randomly assigned to groups given BSV (150 mg, n = 99) or TDF (300 mg, n = 98) for 48 weeks. We evaluated virologic responses to therapy (HBV DNA <69 IU/mL or 400 copies/ml), bone mineral density (BMD), and renal outcomes for safety analysis. The main efficacy endpoint was the proportion of patients with a virologic response at week 48. After 48 weeks, TDF was switched to BSV (150 mg) for an additional 48 weeks.
RESULTS


After 48 weeks of treatment, 80.9% of patients given BSV and 84.9% of patients given TDF met the efficacy endpoint, indicating the non-inferiority of BSV to TDF. At week 96, 87.2% of patients in the BSV-BSV and 85.7% of patients in the TDF-BSV had a virologic response. At week 48, changes in hip and spine BMD differed significantly between the BSV and TDF groups, whereas the estimated glomerular filtration rate in the TDF group was significantly lower than that in the BSV group. However, at 96 weeks, there were no significant differences in BMD and estimated glomerular filtration rate between the BSV-BSV and TDF-BSV groups.
CONCLUSIONS


BSV has antiviral efficacy comparable to that of TDF after 48 weeks of treatment, with durable effects for 96 weeks. BSV has a better safety profile than TDF, in terms of bone and renal outcomes. ClinicalTrials.gov no: NCT01937806.",2019,"At week 48, changes in hip and spine BMD differed significantly between the BSV and TDF groups, whereas the estimated glomerular filtration rate in the TDF group was significantly lower than that in the BSV group.","['197 patients with chronic HBV infection at 22 sites in South Korea, from November 2013 through February 2016', 'Chronic Hepatitis B Virus Infection', 'patients with chronic HBV infection in Korea']","['Tenofovir Disoproxil Fumarate', 'BSV', 'BSV vs tenofovir disoproxil fumarate (TDF', 'TDF', 'Besifovir dipivoxil maleate (BSV', 'Besifovir Dipivoxil Maleate']","['virologic responses', 'antiviral efficacy', 'BMD and estimated glomerular filtration rate', 'changes in hip and spine BMD', 'antiviral efficacy and safety', 'proportion of patients with a virologic response', 'glomerular filtration rate', 'virologic response', 'bone mineral density (BMD), and renal outcomes for safety analysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C3811844'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",197.0,0.136686,"At week 48, changes in hip and spine BMD differed significantly between the BSV and TDF groups, whereas the estimated glomerular filtration rate in the TDF group was significantly lower than that in the BSV group.","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Young Kul', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': ""Department of Internal Medicine, Catholic University Medical College St Vincent's Hospital, Suwon, Korea.""}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'Yong Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Yong Kyun', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gun Young', 'Initials': 'GY', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Kwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Soon Ho', 'Initials': 'SH', 'LastName': 'Um', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Paik Hospital, Inje University, Pusan, Korea.'}, {'ForeName': 'Byung Seok', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gacheon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Hong Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Seung Kew', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwan Sik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wan Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.'}, {'ForeName': 'Neung Hwa', 'Initials': 'NH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Jin', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'Kyun-Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Pharmacology, School of Medicine, Konkuk University, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Ildong Pharmaceutical Co, Ltd, Seoul, Korea.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. Electronic address: gihankhys@yuhs.ac.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.001']
155,32312114,Sonothrombolysis Improves Myocardial Dynamics and Microvascular Obstruction Preventing Left Ventricular Remodeling in Patients With ST Elevation Myocardial Infarction.,"BACKGROUND


It has recently been demonstrated that high-energy diagnostic transthoracic ultrasound and intravenous microbubbles dissolve thrombi (sonothrombolysis) and increase angiographic recanalization rates in patients with ST-segment-elevation myocardial infarction. We aimed to study the effect of sonothrombolysis on the myocardial dynamics and infarct size obtained by real-time myocardial perfusion echocardiography and their value in preventing left ventricular remodeling.
METHODS


One hundred patients with ST-segment-elevation myocardial infarction were randomized to therapy (50 patients treated with sonothrombolysis and percutaneous coronary intervention) or control (50 patients treated with percutaneous coronary intervention only). Left ventricular volumes, ejection fraction, risk area (before treatment), myocardial perfusion defect over time (infarct size), and global longitudinal strain were determined by quantitative real-time myocardial perfusion echocardiography and speckle tracking echocardiography imaging.
RESULTS


Risk area was similar in the control and therapy groups (19.2±10.1% versus 20.7±8.9%;  P =0.56) before treatment. The therapy group presented a behavior significantly different than control group over time ( P <0.001). The perfusion defect was smaller in the therapy at 48 to 72 hours even in the subgroup of patients with no recanalization at first angiography (12.9±6.5% therapy versus 18.8±9.9% control;  P =0.015). The left ventricular global longitudinal strain was higher in the therapy than control immediately after percutaneous coronary intervention (14.1±4.1% versus 12.0±3.3%;  P =0.012), and this difference was maintained until 6 months (17.1±3.5% versus 13.6±3.6%;  P <0.001). The only predictor of left ventricular remodeling was treatment with sonothrombolysis: the control group was more likely to exhibit left ventricular remodeling with an odds ratio of 2.79 ([95% CI, 0.13-6.86];  P =0.026).
CONCLUSIONS


Sonothrombolysis reduces microvascular obstruction and improves myocardial dynamics in patients with ST-segment-elevation myocardial infarction and is an independent predictor of left ventricular remodeling over time.",2020,The therapy group presented a behavior significantly different than control group over time ( P <0.001).,"['50 patients treated with percutaneous coronary intervention only', 'Patients With ST Elevation Myocardial Infarction', 'patients with ST-segment-elevation myocardial infarction', 'One hundred patients with ST-segment-elevation myocardial infarction']","['sonothrombolysis', 'sonothrombolysis and percutaneous coronary intervention) or control']","['quantitative real-time myocardial perfusion echocardiography and speckle tracking echocardiography imaging', 'Risk area', 'perfusion defect', 'left ventricular remodeling', 'myocardial dynamics', 'left ventricular global longitudinal strain', 'microvascular obstruction', 'angiographic recanalization rates', 'Left ventricular volumes, ejection fraction, risk area (before treatment), myocardial perfusion defect over time (infarct size), and global longitudinal strain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0428858', 'cui_str': 'Myocardial perfusion defect'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",100.0,0.0257246,The therapy group presented a behavior significantly different than control group over time ( P <0.001).,"[{'ForeName': 'Miguel O D', 'Initials': 'MOD', 'LastName': 'Aguiar', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Tavares', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}, {'ForeName': 'Jeane M', 'Initials': 'JM', 'LastName': 'Tsutsui', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}, {'ForeName': 'Agostina M', 'Initials': 'AM', 'LastName': 'Fava', 'Affiliation': 'University of Nebraska Medical Center, Omaha (A.M.F., A.G., T.R.P.).'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Borges', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Mucio T', 'Initials': 'MT', 'LastName': 'Oliveira', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Soeiro', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Henrique B', 'Initials': 'HB', 'LastName': 'Ribeiro', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Hsu P', 'Initials': 'HP', 'LastName': 'Chiang', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}, {'ForeName': 'João C N', 'Initials': 'JCN', 'LastName': 'Sbano', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goldsweig', 'Affiliation': 'University of Nebraska Medical Center, Omaha (A.M.F., A.G., T.R.P.).'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Rochitte', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Bernardo B C', 'Initials': 'BBC', 'LastName': 'Lopes', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'José A F', 'Initials': 'JAF', 'LastName': 'Ramirez', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Heart Institute (InCor)- University of São Paulo Medical School, Brazil (B.C.B., M.T.O., A.S., J.C.N., H.B.R., C.E.R., B.B.C.L., J.A.F.R., R.K.F.).'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'University of Nebraska Medical Center, Omaha (A.M.F., A.G., T.R.P.).'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Mathias', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School and Fleury Group, Brazil (M.O.D.A., B.G.T., J.M.T., H.P.C., J.C.N.S., W.M.).'}]",Circulation. Cardiovascular imaging,['10.1161/CIRCIMAGING.119.009536']
156,32202965,"Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial.","A randomized controlled phase I/II clinical trial was designed to evaluate the safety and efficacy of encapsulated human umbilical cord mesenchymal stem cells in a plasma-derived biomaterial for regenerative endodontic procedures (REPs) in mature permanent teeth with apical lesions. The trial included 36 patients with mature incisors, canines, or mandibular premolars showing pulp necrosis and apical periodontitis. Patients were randomly and equally allocated between experimental (REP) or conventional root canal treatment (ENDO) groups. On the first visit, cavity access and mechanical preparation of the root canal were performed. Calcium hydroxide medication was used, and the cavity was sealed. Three weeks later, patients were treated following their assigned protocol of ENDO or REP. Clinical follow-up examinations were performed at 6 and 12 mo. Categorical variables were evaluated by Fisher's exact test. Quantitative variables were compared using the Mann-Whitney test. The evolution over time of the percentage of perfusion units and the dimensions of lesion and cortical compromise were explored. After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups. Interestingly, in the REP group, the perfusion unit percentage measured by laser Doppler flowmetry revealed an increase from 60.6% to 78.1% between baseline and 12-mo follow-up. Sensitivity tests revealed an increase of the positive pulp response in the REP group at 12-mo follow-up (from 6% to 56% on the cold test, from 0% to 28% on the hot test, and from 17% to 50% on the electrical test). We present the first clinical safety and efficacy evidence of the endodontic use of allogenic umbilical cord mesenchymal stem cells encapsulated in a plasma-derived biomaterial. The innovative approach, based on biological principles that promote dentin-pulp regeneration, presents a promising alternative for the treatment of periapical pathology (ClinicalTrials.gov NCT03102879).",2020,"After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups.","['mature permanent teeth with apical lesions', 'Periapical Lesions', '36 patients with mature incisors, canines, or mandibular premolars showing pulp necrosis and apical periodontitis']","['allogenic umbilical cord mesenchymal stem cells', 'experimental (REP) or conventional root canal treatment (ENDO', 'Cell-Based Regenerative Endodontics', 'encapsulated human umbilical cord mesenchymal stem cells', 'Calcium hydroxide medication', 'ENDO or REP']","['perfusion unit percentage measured by laser Doppler flowmetry', 'adverse events', 'safety and efficacy', 'positive pulp response']","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0011407', 'cui_str': 'Pulp Necrosis'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4704832', 'cui_str': 'Endodontic, Regenerative'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",36.0,0.0390231,"After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brizuela', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Meza', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Urrejola', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Quezada', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Concha', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ramírez', 'Affiliation': 'Centro ""Activa Biosilicate Technology™"" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Angelopoulos', 'Affiliation': 'Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Cadiz', 'Affiliation': 'Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tapia-Limonchi', 'Affiliation': 'Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khoury', 'Affiliation': 'Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.'}]",Journal of dental research,['10.1177/0022034520913242']
157,32203751,Improving social functioning in community-dwelling patients with schizophrenia: a randomized controlled computer cognitive remediation therapy trial with six months follow-up.,"Computerized cognitive remediation therapy (CCRT) has been found to generally improve cognition among patients with schizophrenia, but its effect on functioning has not been extensively studied. This study addressed this gap in the literature by investigating the effect of CCRT and its long-term efficacy among community-dwelling patients with schizophrenia. 157 Chinese patients with schizophrenia were recruited from communities and randomized to CCRT (n = 78) or treatment as usual (TAU; n = 79) groups for 12 weeks with 4-5 sessions per week. Neurocognition, functioning, and symptoms of participants were assessed at baseline, after treatment, and at the 6 month follow-up. The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score. Significant cognitive benefits for functioning were observed (Personal and Social Performance scale, PSP). Moreover, improvement of the MCCB total score mediated a positive effect on functional capacity (UCSD Performance-based Skills Assessment, UPSA), and mediated decreases in negative symptoms across both groups. CCRT improved social functioning and general cognitive functioning among community-dwelling patients with schizophrenia. These improvements persisted for 6 months after treatment. CCRT also led to improvements in functioning and symptom severity by modulating cognitive functioning.",2020,The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score.,"['community-dwelling patients with schizophrenia', '157 Chinese patients with schizophrenia', 'patients with schizophrenia']","['TAU', 'Computerized cognitive remediation therapy (CCRT', 'CCRT']","['functional capacity (UCSD Performance-based Skills Assessment, UPSA', 'Consensus Cognitive Battery (MCCB) total score and social cognition score', 'social functioning', 'MCCB total score', 'Significant cognitive benefits for functioning were observed (Personal and Social Performance scale, PSP', 'social functioning and general cognitive functioning', 'Neurocognition, functioning, and symptoms', 'negative symptoms']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",157.0,0.0232688,The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score.,"[{'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Zhiren', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Beijing Dongcheng District Institute of Mental Health Care, Beijing 100027, PR. China.'}, {'ForeName': 'Cunli', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Pingan Hospital of Xicheng District, Beijing 100023, PR. China.'}, {'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Beijing Haidian District Institute of Mental Health Prevention, Beijing 100193, PR. China.'}, {'ForeName': 'Zhiwu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Nanyuan Hospital of Fengtai District, Beijing 10076, PR. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'The third Hospital of Chaoyang District, Beijing 100121, PR. China.'}, {'ForeName': 'Yizhuang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China. Electronic address: yzouy@263.net.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China. Electronic address: shupingtan@126.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.112913']
158,32318695,Effect of allopurinol on phosphocreatine recovery and muscle function in older people with impaired physical function: a randomised controlled trial.,"BACKGROUND


Allopurinol has vascular antioxidant effects and participates in purinergic signalling within muscle. We tested whether allopurinol could improve skeletal muscle energetics and physical function in older people with impaired physical performance.
METHODS


We conducted a randomised, double blind, parallel group, placebo-controlled trial, comparing 20 weeks of allopurinol 600 mg once daily versus placebo. We recruited community-dwelling participants aged 65 and over with baseline 6-min walk distance of <400 m and no contraindications to magnetic resonance imaging scanning. Outcomes were measured at baseline and 20 weeks. The primary outcome was post-exercise phosphocreatine (PCr) recovery rate measured using 31P magnetic resonance spectroscopy of the calf. Secondary outcomes included 6-min walk distance, short physical performance battery (SPPB), lean body mass measured by bioimpedance, endothelial function and quality of life.
RESULTS


In total, 124 participants were randomised, mean age 80 (SD 6) years. A total of 59 (48%) were female, baseline 6-min walk distance was 293 m (SD 80 m) and baseline SPPB was 8.5 (SD 2.0). Allopurinol did not significantly improve PCr recovery rate (treatment effect 0.10 units [95% CI, -0.07 to 0.27], P = 0.25). No significant changes were seen in endothelial function, quality of life, lean body mass or SPPB. Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]). This was more pronounced in those with high baseline oxidative stress and urate.
CONCLUSION


Allopurinol improved 6-min walk distance but not PCr recovery rate in older people with impaired physical function. Antioxidant strategies to improve muscle function for older people may need to be targeted at subgroups with high baseline oxidative stress.",2020,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","['older people with impaired physical performance', 'older people', 'recruited community-dwelling participants aged 65 and over with baseline 6-min walk distance of <400\xa0m and no contraindications to magnetic resonance imaging scanning', '124 participants were randomised, mean age 80 (SD 6) years', 'older people with impaired physical function']","['Allopurinol', 'allopurinol', 'placebo']","['post-exercise phosphocreatine (PCr) recovery rate', 'PCr recovery rate', '6-min walk distance, short physical performance battery (SPPB), lean body mass measured by bioimpedance, endothelial function and quality of life', 'endothelial function, quality of life, lean body mass or SPPB', 'skeletal muscle energetics and physical function', 'phosphocreatine recovery and muscle function', '6-min walk distance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",124.0,0.800177,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Clarke', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hutcheon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gingles', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Priba', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Nicholas', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cavin', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",Age and ageing,['10.1093/ageing/afaa061']
159,31271885,Effect of Sirolimus on Immune Reconstitution Following Myeloablative Allogeneic Stem Cell Transplantation: An Ancillary Analysis of a Randomized Controlled Trial Comparing Tacrolimus/Sirolimus and Tacrolimus/Methotrexate (Blood and Marrow Transplant Clinical Trials Network/BMT CTN 0402).,"Although allogeneic hematopoietic cell transplantation (HCT) is a potentially curative therapy for hematologic neoplasms, one of its limiting toxicities continues to be graft-versus-host disease, both acute (aGVHD) and chronic (cGVHD). Sirolimus is a mammalian target of rapamycin inhibitor that has proven effective in GVHD prophylaxis in combination with a calcineurin inhibitor, such as tacrolimus. The impact of sirolimus on immune reconstitution has not been comprehensively investigated in vivo thus far, however. Here we present an ancillary analysis of the randomized study BMT-CTN 0402 that examined the effect of sirolimus on immune subsets post-transplantation. We further examine the association between different lymphocyte subsets and outcomes post-transplantation in each arm. BMT-CTN 0402 was a randomized trial (n = 304) comparing 2 GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) and tacrolimus/methotrexate (Tac/MTX), in patients with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome undergoing myeloablative HLA-matched HCT. There were no differences in 114-day GVHD-free survival (primary endpoint), aGVHD, cGVHD, relapse, or overall survival (OS) between the 2 arms. Of the 304 patients, 264 had available samples for the current immune reconstitution analysis. Blood samples were collected at 1, 3, 6, 12, and 24 months post-HCT. Multiparameter flow cytometry was performed at the project laboratory (Esoterix Clinical Trials Services) in a blinded fashion, and results for the 2 arms were compared. Multivariable Cox regression models, treating each phenotypic parameter as a time-dependent variable, were constructed to study the impact of reconstitution on clinical outcomes. There were no significant differences in patient and transplantation characteristics between the Tac/Sir and Tac/MTX arms in this analysis. Absolute lymphocyte count and CD3 +  cell, CD4 +  cell, and conventional T cell (Tcon) counts were significantly decreased in the Tac/Sir arm for up to 3 months post-HCT, whereas CD8 +  cells recovered even more slowly (up to 6 months) in this arm. Interestingly, there was no clear difference in the absolute number of regulatory T cells (Tregs, defined as CD4 + CD25 +  cells) between the 2 arms at any point post-HCT; however, the Treg:Tcon ratio was significantly greater in the Tac/Sir arm in the first 3 months after HCT. B lymphocyte recovery was significantly compromised in the Tac/Sir arm from 1 month to 6 months after HCT, whereas natural killer cell reconstitution was not affected in the Tac/Sir arm. In the outcomes analysis, higher numbers of CD3 +  cells, CD4 +  cells, CD8 +  cells, and Tregs were associated with better OS. Neither Treg numbers nor the Treg:Tcon ratio was correlated with GVHD. Our findings indicate that Tac/Sir has a more profound T cell suppressive effect than the combination of Tac/MTX in the early post-transplantation period, and particularly compromises the recovery of CD8 +  T cells, which have been implicated in aGVHD. Sirolimus used in vivo with tacrolimus does not appear to result in increased absolute numbers of Tregs, but might have a beneficial effect on the Treg:Tcon balance in the first 3 months after transplantation. Nonetheless, no differences in aGVHD or cGVHD between the 2 arms were observed in the parent randomized trial. Calcineurin-inhibitor free, sirolimus-containing GVHD prophylaxis strategies, incorporating other novel agents, should be investigated further to maximize the potential favorable effect of sirolimus on Treg:Tcon balance in the post-transplantation immune repertoire. Sirolimus significantly compromises B cell recovery in the first 6 months post-HCT, with potential complex effects on cGVHD that merit further study.",2019,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","['myeloablative allogeneic stem-cell transplantation', '264/304 patients had available samples for the current immune reconstitution analysis']","['sirolimus', 'Sirolimus', 'tacrolimus', 'calcineurin inhibitors like tacrolimus', 'rapamycin (mTOR) inhibitor', 'myeloablative HLA-matched transplantation', 'GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) versus tacrolimus/methotrexate (Tac/MTX', 'Tacrolimus/Sirolimus with Tacrolimus/Methotrexate', 'Tac/MTX', 'allogeneic hematopoietic cell transplantation (HCT']","['NK cells reconstitution', 'absolute number of regulatory T-cells', '114-day GVHD free survival', 'Blood samples', 'immune reconstitution', 'compromises B-cell recovery', 'patient and transplant characteristics', 'Absolute lymphocyte count (ALC), CD3+, CD4+ and conventional T cell counts', 'higher numbers of CD3+, CD4', 'aGVHD or cGVHD', 'B-lymphocyte recovery', 'overall survival', 'acute or chronic GVHD, relapse or overall survival']","[{'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0394254,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","[{'ForeName': 'Mahasweta', 'Initials': 'M', 'LastName': 'Gooptu', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mahasweta_gooptu@dfci.harvard.edu.'}, {'ForeName': 'Haesook T', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.06.029']
160,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


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


Prospective crossover physiologic study.
SETTING


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


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


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


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


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
161,31978225,High total metabolic tumor volume at baseline predicts survival independent of response to therapy.,"Early identification of ultra-risk diffuse large B-cell lymphoma (DLBCL) patients is needed to aid stratification to innovative treatment. Previous studies suggested high baseline total metabolic tumor volume (TMTV) negatively impacts survival of DLBCL patients. We analyzed the prognostic impact of TMTV and prognostic indices in DLBCL patients, aged 60 to 80 years, from the phase 3 REMARC study that randomized responding patients to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) into maintenance lenalidomide or placebo. TMTV was computed on baseline positron emission tomography/computed tomography using the 41% maximum standardized uptake value method; the optimal TMTV cutoff for progression-free (PFS) and overall survival (OS) was determined and confirmed by a training validation method. There were 301 out of 650 evaluable patients, including 192 patients classified as germinal center B-cell-like (GCB)/non-GCB and MYC/BCL2 expressor. Median baseline TMTV was 238 cm3; optimal TMTV cutoff was 220 cm3. Patients with high vs low TMTV showed worse/higher Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, stage III or IV disease, >1 extranodal site, elevated lactate dehydrogenase, International Prognostic Index (IPI) 3-5, and age-adjusted IPI 2-3. High vs low TMTV significantly impacted PFS and OS, independent of maintenance treatment. Although the GCB/non-GCB profile and MYC expression did not correlate with TMTV/survival, BCL2 >70% impacted PFS and could be stratified by TMTV. Multivariate analysis identified baseline TMTV and ECOG PS as independently associated with PFS and OS. Even in responding patients, after R-CHOP, high baseline TMTV was a strong prognosticator of inferior PFS and OS. Moreover, TMTV combined with ECOG PS may identify an ultra-risk DLBCL population. This trial was registered at www.clinicaltrials.gov as #NCT01122472.",2020,"High vs low TMTV significantly impacted PFS (HR=2.3; P = .0002) and OS (HR=3.3; P = .0001), independent of maintenance treatment.","['301/650 evaluable patients (n=155 lenalidomide; n=146 placebo), including 192 patients classified as GCB/non-GCB and MYC/BCL2 expressor', 'DLBCL patients, aged 60 to 80 years, from the phase III REMARC study that randomized responding patients to RCHOP into maintenance lenalidomide or', 'patients aged 60 to 80 years responding to R-CHOP', 'ultra-risk diffuse large B-cell lymphoma (DLBCL) patients']","['TMTV', 'placebo', 'TMTV combined with ECOG PS']","['PFS', 'High total metabolic tumor volume', 'GCB/non-GCB profile and MYC expression', 'TMTV cut-off for progression-free (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.130353,"High vs low TMTV significantly impacted PFS (HR=2.3; P = .0002) and OS (HR=3.3; P = .0001), independent of maintenance treatment.","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Vercellino', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Nuclear Medecine, Paris, France.'}, {'ForeName': 'Anne-Segolene', 'Initials': 'AS', 'LastName': 'Cottereau', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Nuclear Medecine, René Descartes University, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': ""Service d'Hématologie Clinique, Centre Hospitalier Universitaire Dijon, INSERM UMR1231, Dijon, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Department of Hematology, Centre Henri Becquerel, University Rouen, INSERM U1245, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire Nancy, INSERM 1256, Nancy, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Chartier', 'Affiliation': 'The Lymphoma Academic Research Organisation, Statistic, Centre Hospitalier Lyon Sud, Pierre-Benite, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Fruchart', 'Affiliation': ""Hématologie, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen, France.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roulin', 'Affiliation': 'University Hospital Henri-Mondor Assistance Publique-Hôpitaux de Paris, Creteil, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': 'Hôpital de Purpan, Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Gian Matteo', 'Initials': 'GM', 'LastName': 'Pica', 'Affiliation': 'Department of Hematology, Centre Hospitalier Métropole Savoie Chambéry, Chambéry, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Hematology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Centre Hospitalier Universitaire Dupuytren, Limoges, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gonzalez', 'Affiliation': 'Centre Hospitalier René Dubos, Pontoise, France.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Hematology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fitoussi', 'Affiliation': 'Hematology/Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': 'Hematologie, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hematology, Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Sanhes', 'Affiliation': 'Hematology, Centre Hospitalier Marechal Joffre-Hôpital Saint-Jean, Perpignan, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'Hematology, Université Lille, Centre Hospitalier Universitaire Lille, EA 7365 Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': 'Concord Repatriation General Hospital, University of Sydney, Concord NSW, Australia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Corront', 'Affiliation': ""Service d'Hématologie Clinique, Centre Hospitalier Regional Annecy, Annecy, France.""}, {'ForeName': 'Bachra', 'Initials': 'B', 'LastName': 'Choufi', 'Affiliation': 'Hematology, Centre Hospitalier Dr Duchenne, Boulogne-Sur-Mer, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Snauwaert', 'Affiliation': 'Hematology, Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Hematology, Centre Hospitalier Bretagne Atlantique, Vannes, France.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': 'Pathology, INSERM U955, University Hospital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Department of Hematology, INSERM U1052 Hospices Civils de Lyon, University of Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaulard', 'Affiliation': 'Pathology, INSERM U955, University Hospital Henri-Mondor Assistance Publique-Hôpitaux de Paris, Créteil, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': 'Lymphoma Study Association-Imaging, Hospital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, University Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Hemato-Oncology, Paris, France; and.'}]",Blood,['10.1182/blood.2019003526']
162,32203739,Occupation-focused intervention for in-patient mental health settings: Pilot study of effectiveness.,"PURPOSE


Participation in meaningful occupation is associated with recovery in serious mental illnesses, however, few evidence-based, occupation-focused interventions for hospital settings exist. This study investigated the effectiveness of ""Occupational Connections"" (OC), a manualized, short-term, group intervention, addressing issues in daily-life occupations' participation and functioning of people with serious mental illness as early as during hospitalization.
METHODS


Thirty-three inpatients with schizophrenia completed single-blind, pre-post study procedures (up to 10 weeks) in two groups: OC group intervention and open leisure activity group (control condition), in addition to treatment as usual. They were assessed for occupation and participation dimensions, perceptions of services as recovery-oriented, comprehensive cognitive functioning and schizophrenia symptoms. The sampling was convenience with sequential group allocation.
RESULTS


Improvements were found in the study group in the following measurements: intention to participate in daily activities (t(15) = -2.62, p < .05), participation diversity (t(15) = -2.11, p < .05), experience the recovery orientation of the service (t(15) = -3.15, p < .01), functional capacity (t(15) = -3.44, p < .01), cognitive abilities of language understanding, memory and shifting (-4.5<t(15)<3.3, p < .05), and schizophrenia symptoms (positive, negative and general: 8.47<t(15)<9.12, p < .01). The control group has improved on attention (t(16) = -2.89, p < .05), visual-motor organization (t(16) = 2.14, p < .05) and schizophrenia symptoms (4.4<t(16)<6.6, p < .01) only.
CONCLUSIONS


The study provides initial evidence for the effectiveness of OC. The results suggest that interventions with a focus on personal, meaningful daily life occupations such as the OC, may be a useful tool contributing to a positive experience of the in-patient staying and successful community reintegration after acute psychiatric hospitalization.",2020,"RESULTS


Improvements were found in the study group in the following measurements: intention to participate in daily activities (t(15) = -2.62,","['Thirty-three inpatients with schizophrenia completed single-blind, pre-post study procedures (up to 10 weeks) in two groups']","['Occupational Connections"" (OC', 'OC group intervention and open leisure activity group (control condition']","['participation diversity (t(15)\xa0', 'cognitive abilities of language understanding, memory and shifting (-4.5<t(15)<3.3, p\xa0<\xa0.05), and schizophrenia symptoms', 'functional capacity (t(15)\xa0', 'visual-motor organization', 'schizophrenia symptoms', 'recovery orientation of the service (t(15)\xa0', 'occupation and participation dimensions, perceptions of services as recovery-oriented, comprehensive cognitive functioning and schizophrenia symptoms']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",33.0,0.0333788,"RESULTS


Improvements were found in the study group in the following measurements: intention to participate in daily activities (t(15) = -2.62,","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Lipskaya-Velikovsky', 'Affiliation': 'School of Health Profession, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, P.O.B. 39040, Tel Aviv, 6139001, Israel. Electronic address: elenalip@post.tau.ac.il.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Krupa', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Louise D Acton Building, 31 George St, Kingston, ON K7L 3N6, Canada. Electronic address: terry.krupa@queensu.ca.""}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Silvan-Kosovich', 'Affiliation': 'Beer Yaakov- Ness Ziona Mental Health Center, Derech Haim 1, P.O.B. 1, Beer Yaakov, 7035001, Israel. Electronic address: ilana.silvan@gmail.com.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Kotler', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, P.O.B. 39040, Tel Aviv, 6139001, Israel. Electronic address: moshe.kotler@beerness.health.gov.il.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.03.004']
163,31567325,"Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry.","BACKGROUND


The safety and efficacy of intrathecal drug delivery systems (IDDSs) for the treatment of cancer-related pain have been demonstrated in randomized controlled clinical trials (RCTs). Despite positive evidence for this therapy, IDDS remains underutilized to treat cancer pain. Real-world registry data augment existing safety and effectiveness data and are presented here to broaden awareness of this therapeutic option, needed for adequate cancer-related pain treatment, and as a viable tool addressing concerns with systemic opioid use.
METHODS


This prospective, long-term, multicenter (United States, Western Europe, and Latin America) registry started in 2003 to monitor the performance of SynchroMed Infusion Systems. Patient-reported outcomes were added in 2013. Before data acquisition, all sites obtained Ethics Committee/Institutional Review Board approval and written patient consent. The study was registered (NCT01524276 at clinicaltrials.gov) before patients were enrolled. Patients who provided informed consent were enrolled in the registry at initial IDDS implant or replacement.
RESULTS


Through July 2017, 1403 patients with cancer pain were enrolled and implanted. The average (minimum/maximum) age of patients was 59 years (13/93 years), with 56.6% female. The most frequent cancer types were lung, breast, colon/rectal, pancreatic, and prostate. The majority of patients whose registry follow-up ended (87%; 1141/1311) were followed through death, with 4.3% (n = 57) exiting due to device explant or therapy discontinuation; the remaining 113 (8.6%) discontinued for reasons such as transfer of care, lost to follow-up, and site closure. Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41). Infection requiring surgical intervention (IDDS explant, replacement, pocket revision, irrigation and debridement, etc) was reported in 3.2% of patients.
CONCLUSIONS


Adequate and improved pain control in patients with cancer, even in advanced stages, with concurrent quality of life maintenance is attainable. Results from this large-scale, multicenter, single-group cohort supplement existing RCT data that support IDDS as a safe and effective therapeutic option with a positive benefit-risk ratio in the treatment of cancer pain.",2020,"Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41).","['Cancer Pain', 'patients with cancer', 'Patients who provided informed consent were enrolled in the registry at initial IDDS implant or replacement', 'cancer-related pain', '1403 patients with cancer pain were enrolled and implanted']","['Intrathecal Drug Delivery Systems', 'intrathecal drug delivery systems (IDDSs']","['pain control', 'Pain scores']","[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",1403.0,0.0540399,"Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Stearns', 'Affiliation': 'From the Center for Pain and Supportive Care, Phoenix, Arizona.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Abd-Elsayed', 'Affiliation': 'Chronic Pain Medicine, Department of Anesthesiology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Perruchoud', 'Affiliation': 'Department of Anesthesiology and Pain Management, Ensemble Hospitalier de la Côte (EHC), Morges, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Krisstin', 'Initials': 'K', 'LastName': 'Hammond', 'Affiliation': 'From the Center for Pain and Supportive Care, Phoenix, Arizona.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Stromberg', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004425']
164,32317122,"Effect of Interpolated Questions on Podcast Knowledge Acquisition and Retention: A Double-Blind, Multicenter, Randomized Controlled Trial.","STUDY OBJECTIVE


We determine whether interpolated questions in a podcast improve knowledge acquisition and retention.
METHODS


This double-blinded controlled trial randomized trainees from 6 emergency medicine programs to listen to 1 of 2 versions of a podcast, produced de novo on the history of hypertension. The versions were identical except that 1 included 5 interpolated questions to highlight educational points (intervention). There were 2 postpodcast assessments, 1 within 48 hours of listening (immediate posttest) and a second 2 to 3 weeks later (retention test), consisting of the same 15 multiple-choice questions, 5 directly related to the interpolated questions and 10 unrelated. The primary outcome was the difference in intergroup mean assessment scores at each point. A sample size was calculated a priori to identify a significant interarm difference.
RESULTS


One hundred thirty-seven emergency medicine trainees were randomized to listen to a podcast, 69 without interpolated questions (control) and 68 with them (intervention). Although no significant difference was detected at the immediate posttest, trainees randomized to the interpolated arm had a significantly higher mean score on the retention test, with a 5.6% absolute difference (95% confidence interval 0.2% to 10.9%). For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively. There was no significant intergroup difference for noninterpolated questions.
CONCLUSION


Podcasts containing interpolated questions improved knowledge retention at 2 to 3 weeks, driven by the retention of material covered by the interpolated questions. Although the gains may be modest, educational podcasters may improve knowledge retention by using interpolating questions.",2020,"For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively.","['One hundred thirty-seven emergency medicine trainees', 'trainees from 6 emergency medicine programs to listen to 1 of 2 versions of a podcast, produced de novo on the history of hypertension']",['Interpolated Questions'],"['intergroup mean assessment scores', 'knowledge retention', 'knowledge acquisition and retention', 'Podcast Knowledge Acquisition and Retention']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}]",,0.242535,"For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weinstock', 'Affiliation': 'Adena Emergency Medicine Residency, Chillicothe, OH; Department of Emergency Medicine, Wexner Medical Center at The Ohio State University, Columbus, OH. Electronic address: mweinstock@mweinstock.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pallaci', 'Affiliation': 'Adena Emergency Medicine Residency, Chillicothe, OH; Ohio University Heritage College of Osteopathic Medicine, Athens, OH.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Aluisio', 'Affiliation': 'Department of Emergency Medicine, Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Department of Emergency Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston TX.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Gottlieb', 'Affiliation': 'Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, Long Island, NY.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grock', 'Affiliation': 'Division of Emergency Medicine, Greater Los Angeles VA Healthcare System, and Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, LA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Frye', 'Affiliation': 'Adena Regional Medical Center, Chillicothe, OH.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Love', 'Affiliation': 'Department of Emergency Medicine, Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Orman', 'Affiliation': 'St. Charles Medical Center, Bend, OR.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Riddell', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.01.021']
165,30502501,Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders.,"BACKGROUND & AIMS


Scalable and effective treatments are needed for children with functional abdominal pain disorders (FAPDs). We performed a randomized controlled trial of the efficacy and cost effectiveness of cognitive behavioral therapy delivered online (Internet-CBT) compared with usual therapy.
METHODS


We studied children (age, 8-12 y) diagnosed with FAPDs, based on the Rome IV criteria, in Sweden from September 2016 through April 2017. The patients were assigned randomly to groups that received 10 weeks of therapist-guided, internet-delivered cognitive behavioral therapy (Internet-CBT, n = 46) or treatment as usual (treatments within the health care and school systems, including medications and visits to doctors and other health care professionals; n = 44). The primary outcome was global child-rated gastrointestinal symptom severity assessed using the Pediatric Quality of Life Gastrointestinal Symptom scale. All outcomes were collected from September 2016 through January 2018. Secondary outcomes included quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms. Societal costs and costs for health care consumption were collected during the treatment.
RESULTS


Children who received Internet-CBT had a significantly larger improvement in gastrointestinal symptom severity with a medium effect size (Cohen's d = 0.46; 95% CI, 0.05-0.88; number needed to treat, 3.8) compared with children who received the treatment as usual. The children's quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms also improved significantly in the Internet-CBT group compared with the treatment as usual group. The effects of Internet-CBT persisted through 36 weeks of follow-up evaluation. Children who received Internet-CBT had significantly less health care use than children who received treatment as usual, with an average cost difference of US $137 (P = .011). We calculated a cost savings of US $1050 for every child treated with Internet-CBT compared with treatment as usual.
CONCLUSIONS


In a randomized trial of pediatric patients with FAPDs, we found Internet-CBT to be clinically cost effective compared with treatment as usual. Internet-CBT has the potential to increase the availability of treatment for a number of patients and reduce health care costs. ClinicalTrials.gov: NCT02873078.",2019,"Children who received internet CBT had significantly less health care use than children who received usual treatment, with an average cost difference of US $137 (P = .011).","['Children With Functional Abdominal Pain Disorders', 'pediatric patients with FAPDs', 'children with functional abdominal pain disorders (FAPDs', 'children (age, 8-12 y) diagnosed with FAPDs, based on the Rome IV criteria, in Sweden from September 2016 through April 2017']","['Online Cognitive Behavioral Therapy', 'internet CBT', 'therapist-guided, internet-delivered cognitive behavioral therapy (internet CBT, n\xa0= 46) or usual treatment (treatments within the health care and school systems, including medications and visits to doctors and other health care professionals', 'cognitive behavioral therapy delivered online (internet CBT']","['global child-rated gastrointestinal symptom severity assessed using the Pediatric Quality of Life Gastrointestinal Symptom scale', ""quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms"", 'health care use', 'Societal costs and costs for health care consumption', ""children's quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms"", 'gastrointestinal symptom severity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178494', 'cui_str': 'Avoidance Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.097508,"Children who received internet CBT had significantly less health care use than children who received usual treatment, with an average cost difference of US $137 (P = .011).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lalouni', 'Affiliation': 'Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden. Electronic address: maria.lalouni@ki.se.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bonnert', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden; Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ssegonja', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Benninga', 'Affiliation': ""Department of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital/Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bjureberg', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Högström', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sahlin', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Center for Functional Gastrointestinal and Motility Disorders, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Olén', 'Affiliation': ""Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden; Department of Pediatric Gastroenterology and Nutrition, Sachs' Children's Hospital, Stockholm, Sweden.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.043']
166,32310283,Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial.,"Importance


Sleep-disordered breathing (SDB) is common and associated with substantial adverse health consequences. Long wait times for SDB care are commonly reported; however, it is unclear whether wait times for care are associated with clinical outcomes.
Objective


To evaluate the association of wait times for care with clinical outcomes for patients with severe SDB.
Design, Setting, and Participants


This study is a secondary analysis of a randomized clinical noninferiority trial comparing management by alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017. The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary. Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome) were recruited for the study. Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB. Data were analyzed from October 2017 to January 2020.
Main Outcomes and Measures


Outcomes were assessed 3 months after treatment initiation with adherence to PAP therapy as the primary outcome. Secondary outcomes included Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9. Multiple regression models were used to assess the associations between wait times and each of the outcomes. t tests were used to compare wait times for patients who were adherent to PAP therapy (≥4 hours per night for 70% of nights) with those for nonadherent patients.
Results


One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis. The mean time from referral to initial visit was 88 days (95% CI, 79 to 96 days), and the mean time to treatment was 123 days (95% CI, 112 to 133 days). Shorter wait time to treatment initiation was associated with adherence to PAP therapy (odds ratio, 0.99; 95% CI, 0.98 to 0.99; P = .04), greater improvement in Epworth Sleepiness Scale score (mean coefficient, -9.37; 95% CI, -18.51 to -0.24; P = .04), and higher Visit-Specific Satisfaction Instrument-9 score (mean coefficient, -0.024; 95% CI, -0.047 to -0.0015; P = .04) at 3 months. Compared with nonadherent patients, those who were adherent to treatment waited a mean of 15 fewer days (95% CI, 12 to 19 days) for initial assessment (P = .07) and 30 fewer days (95% CI, 23 to 35 days) for treatment initiation (P = .008).
Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction. These findings suggest that system interventions to improve timely access may modify patient behavior and improve clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02191085.",2020,"Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction.","['Patients were excluded if they were suspected of having a concomitant sleep disorder other than SDB or had previously been treated with positive airway pressure (PAP) therapy for SDB', 'The study took place at Foothills Medical Centre Sleep Centre, a tertiary care multidisciplinary sleep clinic at the University of Calgary', 'Patients with severe SDB (defined as a respiratory event index ≥30 events per hour during home sleep apnea testing, mean nocturnal oxygen saturation ≤85%, or suspected sleep hypoventilation syndrome', 'patients with severe SDB', 'Patients With Severe Sleep-Disordered Breathing', 'Data were analyzed from October 2017 to January 2020', 'One hundred fifty-six patients (112 [71.8%] men; mean [SD] age, 56 [12] years) were included in the analysis', 'alternative care practitioners (ACPs) with traditional sleep physician-led care between October 2014 and May 2017']",['Importance\n\n\nSleep-disordered breathing (SDB'],"['mean time from referral to initial visit', 'Treatment Adherence and Clinical Outcomes', 'PAP adherence', 'Epworth Sleepiness Scale score, health-related quality of life, and patient satisfaction measured using the Visit-Specific Satisfaction Instrument-9', 'Epworth Sleepiness Scale score', 'higher Visit-Specific Satisfaction Instrument-9 score', 'daytime sleepiness and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C2732337', 'cui_str': 'Sleep hypoventilation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",,0.181914,"Conclusions and Relevance


Earlier initiation of treatment for severe SDB was associated with better PAP adherence and greater improvements in daytime sleepiness and patient satisfaction.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Thornton', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Willis H', 'Initials': 'WH', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Santana', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Penz', 'Affiliation': 'College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'W Ward', 'Initials': 'WW', 'LastName': 'Flemons', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Fraser', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hanly', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sachin R', 'Initials': 'SR', 'LastName': 'Pendharkar', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3088']
167,32295417,Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial.,"BACKGROUND


Vascular injury and inflammation during percutaneous coronary intervention (PCI) are associated with increased risk of post-PCI adverse outcomes. Colchicine decreases neutrophil recruitment to sites of vascular injury. The anti-inflammatory effects of acute colchicine administration before PCI on subsequent myocardial injury are unknown.
METHODS


In a prospective, single-site trial, subjects referred for possible PCI (n=714) were randomized to acute preprocedural oral administration of colchicine 1.8 mg or placebo.
RESULTS


Among the 400 subjects who underwent PCI, the primary outcome of PCI-related myocardial injury did not differ between colchicine (n=206) and placebo (n=194) groups (57.3% versus 64.2%,  P =0.19). The composite outcome of death, nonfatal myocardial infarction, and target vessel revascularization at 30 days (11.7% versus 12.9%,  P =0.82), and the outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions (2.9% versus 4.7%,  P =0.49) did not differ between colchicine and placebo groups. Among 280 PCI subjects in a nested inflammatory biomarker substudy, the primary biomarker end point, change in interleukin-6 concentrations did not differ between groups 1-hour post-PCI but increased less 24 hours post-PCI in the colchicine (n=141) versus placebo group (n=139; 76% [-6 to 898] versus 338% [27 to 1264],  P =0.02). High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172],  P =0.001).
CONCLUSIONS


Acute preprocedural administration of colchicine attenuated the increase in interleukin-6 and high-sensitivity C-reactive protein concentrations after PCI when compared with placebo but did not lower the risk of PCI-related myocardial injury. Registration: URL: https://www.clinicaltrials.gov; Unique Identifiers: NCT02594111, NCT01709981.",2020,"High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172],  P =0.001).
","['400 subjects who underwent', '280 PCI subjects', 'subjects referred for possible PCI (n=714']","['colchicine', 'PCI', 'percutaneous coronary intervention (PCI', 'placebo', 'colchicine 1.8 mg or placebo', 'Acute Colchicine Administration', 'Colchicine']","['interleukin-6 and high-sensitivity C-reactive protein concentrations', 'PCI-related myocardial injury', 'change in interleukin-6 concentrations', 'death, nonfatal myocardial infarction, and target vessel revascularization', 'outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions', 'High-sensitivity C-reactive protein concentration']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1321565', 'cui_str': 'Cardiovascular angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",714.0,0.63533,"High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172],  P =0.001).
","[{'ForeName': 'Binita', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pillinger', 'Affiliation': 'Section of Rheumatology, Department of Medicine (M.P.), VA New York Harbor Health Care System.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Division of Biostatistics, Department of Population Health (H.Z., Y.X.), New York University School of Medicine.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Cronstein', 'Affiliation': 'Division of Rheumatology, Department of Medicine (M.P., B.C.), New York University School of Medicine.'}, {'ForeName': 'Yuhe', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Division of Biostatistics, Department of Population Health (H.Z., Y.X.), New York University School of Medicine.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lorin', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Smilowitz', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Feit', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ratnapala', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Norma M', 'Initials': 'NM', 'LastName': 'Keller', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008717']
168,30772283,"Routine monitoring with pleural manometry during therapeutic large-volume thoracentesis to prevent pleural-pressure-related complications: a multicentre, single-blind randomised controlled trial.","BACKGROUND


In patients with non-expandable lung, removal of pleural fluid can result in excessively negative pleural pressure, which is associated with chest discomfort, pneumothorax, and re-expansion pulmonary oedema. Pleural manometry is widely used to safeguard against pressure-related complications during thoracentesis despite little evidence to support the approach. We investigated whether monitoring of pleural pressure with manometry during thoracentesis could protect against complications compared with assessment of symptoms alone.
METHODS


We did a prospective randomised single-blind trial involving patients with large pleural effusions at two academic medical centres in, Nashville, TN, and Baltimore, MD, USA. Eligible patients were adults with free-flowing effusions estimated to be at least 0·5 L who could remain seated throughout the procedure. Patients were randomly assigned 1:1 to receive thoracentesis guided by symptoms only (control) or by symptoms plus manometry at timepoints based on volume drained. The randomisation schedule was computer generated, used permuted blocks of four and six, and was stratified by participating institution. Patients, who were masked to study-group assignment, were asked to rate chest discomfort on 100 mm visual analogue scales before, during, and after drainage. In both groups drainage was discontinued before complete evacuation of pleural fluid if patients developed persistent chest discomfort, intractable cough, or other complications. In the manometry group, an additional criterion for stopping was if end-expiratory pleural pressure was lower than -20 cm H 2 O or declined by more than 10 cm H 2 O between two measurements to a value less than or equal to -10 cm H 2 O. The primary outcome was overall chest discomfort from before the start to after the procedure measured by patients 5 min after the end of drainage. Analysis was by modified intention to treat (ie, included all patients with any procedure or outcome data). This trial is registered with ClinicalTrials.gov, number NCT02677883.
FINDINGS


Between March 4, 2016, and Sept 8, 2017, 191 patients were screened, of whom 128 were randomly assigned treatment and 124 were included in the final analysis (62 in each group). Four patients were excluded because of manometer malfunction (n=2), inability to access effusion due to pleural tumour burden (n=1), and inability to remain seated (n=1). Groups did not differ for the primary outcome (mean difference in chest discomfort score 2·4 mm, 95% CI -5·7 to 10·5, p=0·56). Six (10%) of 62 patients in the control group had asymptomatic pneumothorax ex vacuo compared with none in the manometry group (p=0·01). No serious complications occurred in either group.
INTERPRETATION


Measurement of pleural pressure by manometry during large-volume thoracentesis does not alter procedure-related chest discomfort. Our findings do not support the routine use of this approach.
FUNDING


Centurion Medical Products.",2019,"Groups did not differ for the primary outcome (mean difference in chest discomfort score 2·4 mm, 95% CI -5·7 to 10·5, p=0·56).","['Between March 4, 2016, and Sept 8, 2017, 191 patients were screened, of whom 128 were randomly assigned treatment and 124 were included in the final analysis (62 in each group', 'Four patients were excluded because of manometer malfunction (n=2), inability to access effusion due to pleural tumour burden (n=1), and inability to remain seated (n=1', 'Eligible patients were adults with free-flowing effusions estimated to be at least 0·5 L who could remain seated throughout the procedure', 'patients with large pleural effusions at two academic medical centres in, Nashville, TN, and Baltimore, MD, USA']","['thoracentesis guided by symptoms only (control) or by symptoms plus manometry at timepoints based on volume drained', 'Routine monitoring with pleural manometry']","['serious complications', 'asymptomatic pneumothorax ex vacuo', 'overall chest discomfort', 'chest discomfort score', 'persistent chest discomfort, intractable cough, or other complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2720530', 'cui_str': 'Manometer (physical object)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}]","[{'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1960446', 'cui_str': 'Pneumothorax ex vacuo (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",4.0,0.396658,"Groups did not differ for the primary outcome (mean difference in chest discomfort score 2·4 mm, 95% CI -5·7 to 10·5, p=0·56).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lentz', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Lerner', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jasleen K', 'Initials': 'JK', 'LastName': 'Pannu', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Merrick', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Roller', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Walston', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Valenti', 'Affiliation': 'Department of Radiology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Goddard', 'Affiliation': 'Department of Radiology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Huggins', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Otis B', 'Initials': 'OB', 'LastName': 'Rickman', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Lonny', 'Initials': 'L', 'LastName': 'Yarmus', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Light', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA. Electronic address: fabien.maldonado@vanderbilt.edu.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(18)30421-1']
169,32314132,"Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas.","BACKGROUND


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


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


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


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


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


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


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


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


clinicaltrials.gov , Identifier: NCT03881657.",2020,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"['Participants were recruited at a clinic between November 24, 2015, and June 30, 2016', 'chronically ill adults', 'persons with SPMI and co-morbid chronic disease in a US-Mexico border community', '416 participants', 'persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border', 'Persons with severe, persistent mental illness (SPMI', 'population with SPMI in a socioeconomically distressed region of the USA', 'Persons with Severe, Persistent Mental Illness in Southern Texas']","['reverse colocated integrated care', 'Receipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only', 'Reverse Colocated Integrated Care', 'reverse colocated integrated care intervention', 'usual care']","['adverse effects', 'blood pressure', 'health outcomes', 'HbA1c, BMI, total cholesterol, and depressive symptoms', 'blood pressure and HbA1c', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",416.0,0.130521,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"[{'ForeName': 'Karen Sautter', 'Initials': 'KS', 'LastName': 'Errichetti', 'Affiliation': 'Department of Movement Arts, Health Promotion and Leisure Studies, Bridgewater State University, 325 Plymouth Street, Bridgewater, MA, 02325, USA. ksautter@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Gaitan', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'M Marlen', 'Initials': 'MM', 'LastName': 'Ramirez', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05778-2']
170,31628854,Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial.,"Ubrogepant is a novel, oral calcitonin gene-related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double-blind, four-period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open-label active control, and the primary end point was change from baseline in Fridericia-corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo-corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10-millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration-based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.",2020,"The 90% CI upper bounds were 2.46 msec and 2.69 msec for ubrogepant 100 mg and 400 mg, respectively.","['Healthy Adults', 'healthy adults']","['therapeutic (100 mg) and supra-therapeutic (400 mg) ubrogepant doses versus placebo', 'Moxifloxacin', 'moxifloxacin', 'placebo', 'placebo-corrected ΔQTcF (ΔΔQTcF']","['Assay sensitivity', 'Fridericia-corrected QT intervals (ΔQTcF', 'cardiac repolarization', 'QTcF prolongation']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.279038,"The 90% CI upper bounds were 2.46 msec and 2.69 msec for ubrogepant 100 mg and 400 mg, respectively.","[{'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McGeeney', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1696']
171,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


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


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


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


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
172,32276664,Transfer of motor skill between virtual reality viewed using a head-mounted display and conventional screen environments.,"BACKGROUND


Virtual reality viewed using a head-mounted display (HMD-VR) has the potential to be a useful tool for motor learning and rehabilitation. However, when developing tools for these purposes, it is important to design applications that will effectively transfer to the real world. Therefore, it is essential to understand whether motor skills transfer between HMD-VR and conventional screen-based environments and what factors predict transfer.
METHODS


We randomized 70 healthy participants into two groups. Both groups trained on a well-established measure of motor skill acquisition, the Sequential Visual Isometric Pinch Task (SVIPT), either in HMD-VR or in a conventional environment (i.e., computer screen). We then tested whether the motor skills transferred from HMD-VR to the computer screen, and vice versa. After the completion of the experiment, participants responded to questions relating to their presence in their respective training environment, age, gender, video game use, and previous HMD-VR experience. Using multivariate and univariate linear regression, we then examined whether any personal factors from the questionnaires predicted individual differences in motor skill transfer between environments.
RESULTS


Our results suggest that motor skill acquisition of this task occurs at the same rate in both HMD-VR and conventional screen environments. However, the motor skills acquired in HMD-VR did not transfer to the screen environment. While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience. Conversely, motor skills acquired in a conventional screen environment not only transferred but improved in HMD-VR, and this increase in motor skill performance could be predicted by self-reported factors of presence, gender, age and video game use.
CONCLUSIONS


These findings suggest that personal factors may predict who is likely to have better transfer of motor skill to and from HMD-VR. Future work should examine whether these and other predictors (i.e., additional personal factors such as immersive tendencies and task-specific factors such as fidelity or feedback) also apply to motor skill transfer from HMD-VR to more dynamic physical environments.",2020,"While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience.",['70 healthy participants into two groups'],"['Sequential Visual Isometric Pinch Task (SVIPT), either in HMD-VR or in a conventional environment (i.e., computer screen']","['HMD-VR', 'motor skill performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",70.0,0.0157684,"While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience.","[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Juliano', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sook-Lei', 'Initials': 'SL', 'LastName': 'Liew', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA. sliew@usc.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00678-2']
173,32108022,Medication Adherence During Adjunct Therapy With Statins and ACE Inhibitors in Adolescents With Type 1 Diabetes.,"OBJECTIVE


Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes.
RESEARCH DESIGN AND METHODS


There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count.
RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count ( r  = 0.82,  P  < 0.001). Factors associated with adherence were age, glycemic control, and country.
CONCLUSIONS


We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out.",2020,"RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","['Adolescents With Type 1 Diabetes', 'adolescents with type 1 diabetes', '443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs']","['placebo', 'Statins and ACE Inhibitors']","['Adherence based on MEMS and pill count', 'Adherence', 'adherence based on MEMS and pill count', 'Median adherence', 'Medication Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",443.0,0.0573073,"RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","[{'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Niechciał', 'Affiliation': 'Department of Pediatric Diabetes, Endocrinology and Obesity, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stevens', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ""Evelina Children's Hospital, Guy's and St Thomas' National Health Service Foundation Trust, London, U.K.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': 'Institute of Cellular Medicine (Diabetes), Faculty of Clinical Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology & Metabolism, University of Oxford, Oxford, U.K.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0884']
174,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N  = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N  = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643']
175,31274603,Impact of Caffeine Ingestion on the Driving Performance of Anesthesiology Residents After 6 Consecutive Overnight Work Shifts.,"BACKGROUND


Residency training in anesthesiology involves care of hospitalized patients and necessitates overnight work, resulting in altered sleep patterns and sleep deprivation. Caffeine consumption is commonly used to improve alertness when fatigued after overnight work, in preparation for the commute home.
METHODS


We studied the impact of drinking a caffeinated energy drink (160 mg of caffeine) on driving performance in a high-fidelity, virtual reality driving simulator (Virginia Driving Safety Laboratory using the Driver Guidance System) in anesthesiology resident physicians immediately after 6 consecutive night-float shifts. Twenty-six residents participated and were randomized to either consume a caffeinated or noncaffeinated energy drink 60 minutes before the driving simulation session. After a subsequent week of night-float work, residents performed the same driving session (in a crossover fashion) with the opposite intervention. Psychomotor vigilance task (PVT) testing was used to evaluate reaction time and lapses in attention.
RESULTS


After 6 consecutive night-float shifts, anesthesiology residents who consumed a caffeinated energy drink had increased variability in driving for throttle, steering, and speed during the first 10 minutes of open-road driving but proceeded to demonstrate improved driving performance with fewer obstacle collisions (epoch 2: 0.65 vs 0.87; epoch 3: 0.47 vs 0.95; P = .03) in the final 30 minutes of driving as compared to driving performance after consumption of a noncaffeinated energy drink. Improved driving performance was most apparent during the last 30 minutes of the simulated drive in the caffeinated condition. Mean reaction time between the caffeine and noncaffeine states differed significantly (278.9 ± 29.1 vs 294.0 ± 36.3 milliseconds; P = .021), while the number of major lapses (0.09 ± 0.43 vs 0.27 ± 0.55; P = .257) and minor lapses (1.05 ± 1.39 vs 2.05 ± 3.06; P = .197) was not significantly different.
CONCLUSIONS


After consuming a caffeinated energy drink on conclusion of 6 shifts of night-float work, anesthesiology residents had improved control of driving performance variables in a high-fidelity driving simulator, including a significant reduction in collisions as well as slightly faster reaction times.",2020,"Mean reaction time between the caffeine and noncaffeine states differed significantly (278.9 ± 29.1 vs 294.0 ± 36.3 milliseconds; P = .021), while the number of major lapses (0.09 ± 0.43 vs 0.27 ± 0.55; P = .257) and minor lapses (1.05 ± 1.39 vs 2.05 ± 3.06; P = .197) was not significantly different.
","['anesthesiology resident physicians immediately after 6 consecutive night-float shifts', 'Anesthesiology Residents', 'Twenty-six residents participated']","['Caffeine consumption', 'Psychomotor vigilance task (PVT', 'Caffeine Ingestion', 'drinking a caffeinated energy drink (160 mg of caffeine', 'consume a caffeinated or noncaffeinated energy drink 60 minutes before the driving simulation session']","['reaction time and lapses in attention', 'control of driving performance variables', 'number of major lapses', 'variability in driving for throttle, steering, and speed', 'Mean reaction time', 'driving performance']","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",26.0,0.037363,"Mean reaction time between the caffeine and noncaffeine states differed significantly (278.9 ± 29.1 vs 294.0 ± 36.3 milliseconds; P = .021), while the number of major lapses (0.09 ± 0.43 vs 0.27 ± 0.55; P = .257) and minor lapses (1.05 ± 1.39 vs 2.05 ± 3.06; P = .197) was not significantly different.
","[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Huffmyer', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kleiman', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Moncrief', 'Affiliation': 'Psychiatry and Neurobehavioral Sciences.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Scalzo', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cox', 'Affiliation': 'Psychiatry and Neurobehavioral Sciences.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Nemergut', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004252']
176,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
177,31628477,Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese.,"CONTEXT


Pre-exercise nutrient availability alters acute metabolic responses to exercise, which could modulate training responsiveness.
OBJECTIVE


To assess acute and chronic effects of exercise performed before versus after nutrient ingestion on whole-body and intramuscular lipid utilization and postprandial glucose metabolism.
DESIGN


(1) Acute, randomized, crossover design (Acute Study); (2) 6-week, randomized, controlled design (Training Study).
SETTING


General community.
PARTICIPANTS


Men with overweight/obesity (mean ± standard deviation, body mass index: 30.2 ± 3.5 kg⋅m-2 for Acute Study, 30.9 ± 4.5 kg⋅m-2 for Training Study).
INTERVENTIONS


Moderate-intensity cycling performed before versus after mixed-macronutrient breakfast (Acute Study) or carbohydrate (Training Study) ingestion.
RESULTS


Acute Study-exercise before versus after breakfast consumption increased net intramuscular lipid utilization in type I (net change: -3.44 ± 2.63% versus 1.44 ± 4.18% area lipid staining, P < 0.01) and type II fibers (-1.89 ± 2.48% versus 1.83 ± 1.92% area lipid staining, P < 0.05). Training Study-postprandial glycemia was not differentially affected by 6 weeks of exercise training performed before versus after carbohydrate intake (P > 0.05). However, postprandial insulinemia was reduced with exercise training performed before but not after carbohydrate ingestion (P = 0.03). This resulted in increased oral glucose insulin sensitivity (25 ± 38 vs -21 ± 32 mL⋅min-1⋅m-2; P = 0.01), associated with increased lipid utilization during exercise (r = 0.50, P = 0.02). Regular exercise before nutrient provision also augmented remodeling of skeletal muscle phospholipids and protein content of the glucose transport protein GLUT4 (P < 0.05).
CONCLUSIONS


Experiments investigating exercise training and metabolic health should consider nutrient-exercise timing, and exercise performed before versus after nutrient intake (ie, in the fasted state) may exert beneficial effects on lipid utilization and reduce postprandial insulinemia.",2020,Training Study - postprandial glycemia was not differentially affected by 6-weeks of exercise training performed before versus after carbohydrate intake (p>0.05).,"['men classified as overweight or obese', 'Men with overweight/obesity (mean±SD, BMI', 'General community']","['Moderate-intensity cycling performed before versus after mixed-macronutrient breakfast (Acute Study) or carbohydrate (Training Study) ingestion', 'Lipid metabolism links nutrient-exercise']","['oral glucose insulin sensitivity', 'lipid utilization', 'net intramuscular lipid utilization', 'postprandial insulinemia']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",,0.0399732,Training Study - postprandial glycemia was not differentially affected by 6-weeks of exercise training performed before versus after carbohydrate intake (p>0.05).,"[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Bradley', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Nurul-Fadhilah', 'Initials': 'NF', 'LastName': 'Abdullah', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Robinson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Chrzanowski-Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Joanisse', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Konstantinos N', 'Initials': 'KN', 'LastName': 'Manolopoulos', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': 'Diabetes & Metabolism Division, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chabowski', 'Affiliation': 'Department of Physiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Brodsky', 'Affiliation': 'Division of Biosciences, University College London, London, United Kingdom.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Koumanov', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz104']
178,31956998,Pharmacokinetics and Pharmacodynamics of Intensive Antituberculosis Treatment of Tuberculous Meningitis.,"The most effective antituberculosis drug treatment regimen for tuberculous meningitis is uncertain. We conducted a randomized controlled trial comparing standard treatment with a regimen intensified by rifampin 15 mg/kg and levofloxacin for the first 60 days. The intensified regimen did not improve survival or any other outcome. We therefore conducted a nested pharmacokinetic/pharmacodynamic study in 237 trial participants to define exposure-response relationships that might explain the trial results and improve future therapy. Rifampin 15 mg/kg increased plasma and cerebrospinal fluid (CSF) exposures compared with 10 mg/kg: day 14 exposure increased from 48.2 hour·mg/L (range 18.2-93.8) to 82.5 hour·mg/L (range 8.7-161.0) in plasma and from 3.5 hour·mg/L (range 1.2-9.6) to 6.0 hour·mg/L (range 0.7-15.1) in CSF. However, there was no relationship between rifampin exposure and survival. In contrast, we found that isoniazid exposure was associated with survival, with low exposure predictive of death, and was linked to a fast metabolizer phenotype. Higher doses of isoniazid should be investigated, especially in fast metabolizers.",2020,Rifampin 15mg/kg increased plasma and CSF exposures compared to 10mg/kg: day 14 plasma AUC 0-24  increased from 48.2h∙mg/L (range 18.2-93.8) to 82.5h∙mg/L (range 8.7-161.0) and CSF AUC 0-24  from 3.5h∙mg/L (range 1.2-9.6) to 6.0h∙mg/L (range 0.7-15.1).,"['tuberculous meningitis', '237 trial participants']","['rifampin 15mg/kg and levofloxacin', 'isoniazid', 'intensive anti-tuberculosis treatment']","['survival', 'plasma and CSF exposures', 'rifampin exposure and survival']","[{'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}]",,0.121718,Rifampin 15mg/kg increased plasma and CSF exposures compared to 10mg/kg: day 14 plasma AUC 0-24  increased from 48.2h∙mg/L (range 18.2-93.8) to 82.5h∙mg/L (range 8.7-161.0) and CSF AUC 0-24  from 3.5h∙mg/L (range 1.2-9.6) to 6.0h∙mg/L (range 0.7-15.1).,"[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Thuy Thuong Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Toi Van', 'Initials': 'TV', 'LastName': 'Pham', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Heemskerk', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pouplin', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chau Thi Hong', 'Initials': 'CTH', 'LastName': 'Tran', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Mai Thi Hoang', 'Initials': 'MTH', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phu Hoan', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Loc Phu', 'Initials': 'LP', 'LastName': 'Phan', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Chau Van Vinh', 'Initials': 'CVV', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Thwaites', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1783']
179,32179212,"Omega-3 fatty-acids modulate symptoms of depressive disorder, serum levels of omega-3 fatty acids and omega-6/omega-3 ratio in children. A randomized, double-blind and controlled trial.","Omega-3 fatty acids (FA) are a promising adjuvant therapy for depressive disorder (DD) in adults. The objective of this single-centre, randomized, double-blind and controlled study was to compare the efficacy of an omega-3 FA fish oil emulsion with a control oil emulsion alongside the standard treatment for depression in children and adolescents suffering from DD or mixed anxiety depressive disorder (MADD) and to analyse serum fatty acid levels and omega-6/omega-3 FA ratio before and after the intervention. 60 children were randomised 1:1 to the intervention (Om3) or active comparator (Om6) groups. Children's Depression Inventory (CDI) ratings were performed at the baseline, every 2 weeks for a 12-week intervention period. Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup. Ratio of omega-6/omega-3 decreased in Om3 but not in Om6 from 24.2/1 to 7.6/1 after 6 weeks, EPA, omega-6/omega-3 ratio, but not DHA, correlated with severity symptoms at the baseline. An omega-3 fatty acid rich fish oil emulsion may be an effective adjuvant supplement during the treatment of depressive disorders in children. Trial registration: ISRCTN 81655012.",2020,Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup.,"['depressive disorder (DD) in adults', 'children and adolescents suffering from DD or mixed anxiety depressive disorder (MADD', 'children', 'depressive disorders in children', '60 children']","['omega-3 fatty acid rich fish oil emulsion', 'Omega-3 fatty-acids', 'intervention (Om3) or active comparator (Om6', 'omega-3 FA fish oil emulsion', 'Omega-3 fatty acids (FA']","[""Children's Depression Inventory (CDI) ratings"", 'serum fatty acid levels and omega-6/omega-3 FA ratio', 'Ratio of omega-6/omega-3 decreased in Om3', 'CDI scores']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1281901', 'cui_str': 'Fatty acid measurement'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.207963,Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Trebatická', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia. Electronic address: jana.trebaticka@fmed.uniba.sk.""}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Hradečná', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Surovcová', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Katrenčíková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Sasinkova 2, Bratislava 813 72, Slovakia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gushina', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff CF10 3AX, United Kingdom.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Waczulíková', 'Affiliation': 'Comenius University, Faculty of Mathematics, Physics and Informatics, Department of Nuclear Physics and Biophysics, Mlynská dolina F1, Bratislava 842 48, Slovakia.'}, {'ForeName': 'Katarína', 'Initials': 'K', 'LastName': 'Sušienková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Biology, Genetics and Clinical Genetics, Sasinkova 4, Bratislava 813 72, Slovakia.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Garaiova', 'Affiliation': 'Research and Development Department, Cultech Ltd., Unit 2 Christchurch Road, Port Talbot, Aberavon SA12 7BZ, United Kingdom.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Šuba', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Ďuračková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Sasinkova 2, Bratislava 813 72, Slovakia.'}]",Psychiatry research,['10.1016/j.psychres.2020.112911']
180,32107938,The Legacy Effect in Treating Hypercholesterolemia.,"BACKGROUND


The duration of randomized controlled clinical trials usually is approximately 3 to 5 years although hypercholesterolemia and other risk factors for atherosclerotic cardiovascular disease (ASCVD) are lifelong conditions.
OBJECTIVES


The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit. We summarize the evidence for the existence of the legacy effect as it pertains to hypercholesterolemia, describe underlying mechanisms, and discuss its relevance to clinical practice.
METHODS


We examined all published (n = 13) randomized clinical trials of lipid-lowering agents compared to placebo or usual care with follow-up after the randomized phase for the presence or absence of a legacy effect.
RESULTS


A legacy effect was demonstrated in all studies. The current US and European guidelines recommend treatment with high-intensity statins for patients with manifest ASCVD and that individualized approach be used for primary prevention.
CONCLUSION


The legacy effect results in significant long-term clinical benefits by preventing fatal and nonfatal events. This implies that early therapy would result in lower event rates. Long-term follow-up should be a part of clinical trial design in order to evaluate the presence or absence of a legacy effect.",2020,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","['patients with manifest ASCVD', 'We examined all published (n = 13) randomized clinical trials of']",['lipid-lowering agents compared to placebo'],['fatal and nonfatal events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0086440', 'cui_str': 'Antilipemic Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",13.0,0.120009,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Mrinali', 'Initials': 'M', 'LastName': 'Shetty', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Yuvraj Singh', 'Initials': 'YS', 'LastName': 'Chowdhury', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420907256']
181,32306525,A single-center blinded randomized clinical trial to evaluate the anti-aging effects of a novel HSF™-based skin care formulation.,"BACKGROUND


Similar to chronic wounds, skin aging is characterized by dysfunction of key cellular regulatory pathways. The hypoxia-inducible factor-1 alpha (HIF-1α) pathway was linked to both conditions. Recent evidence suggests that modulating this pathway can rejuvenate aged fibroblasts and improve skin regeneration. Here, we describe the application of a novel HIF stimulating factor (HSF™)-based formulation for skin rejuvenation.
METHODS


Over a period of 6 weeks using a split-face study design, the effects on skin surface profile, skin moisture, and transepidermal water loss were determined in 32 female subjects (mean age 54, range 32-67 years) by Fast Optical in vivo Topometry of Human Skin (FOITS HD  ), Corneometer, and Tewameter measurements. In addition, a photo documentation was performed for assessment by an expert panel and a survey regarding subject satisfaction was conducted.
RESULTS


No negative skin reactions of dermatological relevance were documented for the test product. A significant reduction in skin roughness could be demonstrated. The clinical evaluation of the images using a validated method confirmed significant improvement of wrinkles, in particular of fine wrinkles, lip wrinkles, and crow's feet. A significant skin moisturizing effect was detected while skin barrier function was preserved. The HSF™-based skin care formulation resulted in a self-reported 94% satisfaction rate.
CONCLUSION


With no negative skin reactions and highly significant effects on skin roughness, wrinkles, and moisturization, the HSF™-based skin care formulation achieved very satisfying outcomes in this clinical trial. Given the favorable results, this approach represents a promising innovation in aesthetic and regenerative medicine.",2020,"The clinical evaluation of the images using a validated method confirmed significant improvement of wrinkles, in particular of fine wrinkles, lip wrinkles, and crow's feet.","['32 female subjects (mean age 54, range 32-67\xa0years) by Fast Optical in vivo Topometry of Human Skin (FOITS HD  ), Corneometer, and Tewameter measurements']","['novel HIF stimulating factor (HSF™)-based formulation', 'novel HSF™-based skin care formulation']","['negative skin reactions of dermatological relevance', 'skin moisturizing effect', 'skin surface profile, skin moisture, and transepidermal water loss', 'skin roughness, wrinkles, and moisturization', 'skin barrier function', 'skin roughness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",32.0,0.0210685,"The clinical evaluation of the images using a validated method confirmed significant improvement of wrinkles, in particular of fine wrinkles, lip wrinkles, and crow's feet.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Duscher', 'Affiliation': 'Department of Plastic and Hand Surgery, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Zeshaan N', 'Initials': 'ZN', 'LastName': 'Maan', 'Affiliation': 'Hagey Laboratory for Pediatric Regenerative Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hu', 'Affiliation': 'Department for Plastic Surgery, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Thor', 'Affiliation': 'College of Pharmacy, University of Florida, Gainesville, FL, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13356']
182,31977817,"A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures.","BACKGROUND


Romosozumab is a bone-forming antibody that increases bone formation and decreases bone resorption. We conducted a double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on the clinical outcomes of open reduction and internal fixation of intertrochanteric or femoral neck hip fractures.
METHODS


Patients (55 to 94 years old) were randomized 2:3:3:3 to receive 3 subcutaneous injections of romosozumab (70, 140, or 210 mg) or a placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary end point was the difference in the mean timed ""Up & Go"" (TUG) score over weeks 6 to 20 for romosozumab versus placebo. Additional end points included the time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH).
RESULTS


A total of 332 patients were randomized: 243 to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 to receive a placebo. Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198). The median time to radiographic evidence of healing was 16.4 to 16.9 weeks across treatment groups. The RUSH scores improved over time across treatment groups but did not differ significantly between the romosozumab and placebo groups. The overall safety and tolerability profile of romosozumab was comparable with that of the placebo.
CONCLUSIONS


Romosozumab did not improve the fracture-healing-related clinical and radiographic outcomes in the study population.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198).","['332 patients were randomized: 243 to receive', 'Hip Fractures', 'Patients (55 to 94 years old']","['Placebo', 'placebo', 'romosozumab', 'Romosozumab']","['median time to radiographic evidence of healing', 'fracture-healing-related clinical and radiographic outcomes', 'RUSH scores', 'time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH', 'overall safety and tolerability profile of romosozumab', 'mean timed ""Up & Go"" (TUG) score', 'bone formation and decreases bone resorption', 'TUG scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661283'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}]",332.0,0.343383,"Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198).","[{'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Miclau', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Theofilos', 'Initials': 'T', 'LastName': 'Karachalios', 'Affiliation': 'Orthopaedic Department UGHL, School of Health Sciences, University of Thessalia, Larissa, Greece.'}, {'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': 'Nowak', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Sancheti', 'Affiliation': 'Sancheti Institute of Orthopaedics and Rehabilitation, Pune, India.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caminis', 'Affiliation': 'Sanofi Genzyme, Bridgewater, New Jersey.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ogo', 'Initials': 'O', 'LastName': 'Egbuna', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00790']
183,32053522,Intraoperative Intravenous and Intra-Articular Plus Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Placebo-Controlled Randomized Controlled Trial.,"BACKGROUND


Combined intraoperative intravenous and intra-articular tranexamic acid (TXA) is 1 of the most effective administration routes to decrease the amount of perioperative blood loss during total knee arthroplasty (TKA). However, the additive effect of postoperative intravenous TXA administration remains unclear. We hypothesized that the postoperative repeated-dose intravenous administration of TXA would provide lower perioperative blood loss.
METHODS


We performed a double-blinded, placebo-controlled trial involving patients undergoing primary TKA. A total of 100 patients who were managed with combined intraoperative intravenous and intra-articular TXA were randomly assigned to receive 3 postoperative 1,000-mg doses of intravenous TXA (TXA group) or 3 postoperative doses of intravenous normal saline solution (placebo group) in a 1:1 ratio. The prespecified primary outcome was perioperative blood loss calculated from patient blood volume and the difference in hemoglobin from preoperatively to postoperative day 3. A post hoc power analysis showed that the number of patients allocated to either the TXA group (n = 46) or the placebo group (n = 54) possessed >80% power to detect a 200-mL difference in perioperative blood loss.
RESULTS


In the intention-to-treat analysis, we found no significant differences in perioperative blood loss between the TXA group and the placebo group through postoperative day 3 (578 ± 229 compared with 640 ± 276 mL, respectively; 95% confidence interval for the difference, -40 to 163 mL; p = 0.23). The prevalence of postoperative thrombotic events did not differ between the 2 groups (4.3% compared with 3.7%, respectively; p > 0.99).
CONCLUSIONS


Postoperative intravenous TXA had no additive effect in reducing perioperative blood loss in patients receiving intraoperative combined intravenous and intra-articular TXA.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"In the intention-to-treat analysis, we found no significant differences in perioperative blood loss between the TXA group and the placebo group through postoperative day 3 (578 ± 229 compared with 640 ± 276 mL, respectively; 95% confidence interval for the difference, -40 to 163 mL; p = 0.23).","['100 patients who were managed with combined intraoperative intravenous and intra-articular TXA', 'patients undergoing primary TKA', 'total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'patients receiving intraoperative combined intravenous and intra-articular TXA']","['intravenous TXA (TXA group) or 3 postoperative doses of intravenous normal saline solution (placebo', 'tranexamic acid (TXA', 'placebo', 'TXA', 'Intraoperative Intravenous and Intra-Articular Plus Postoperative Intravenous Tranexamic Acid', 'Placebo']","['perioperative blood loss', 'prevalence of postoperative thrombotic events', 'perioperative blood loss calculated from patient blood volume and the difference in hemoglobin']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",100.0,0.75446,"In the intention-to-treat analysis, we found no significant differences in perioperative blood loss between the TXA group and the placebo group through postoperative day 3 (578 ± 229 compared with 640 ± 276 mL, respectively; 95% confidence interval for the difference, -40 to 163 mL; p = 0.23).","[{'ForeName': 'Sachiyuki', 'Initials': 'S', 'LastName': 'Tsukada', 'Affiliation': 'Departments of Orthopaedic Surgery (S.T., K.K., M.N., and N.H.) and Anesthesiology (T.M.), Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kurosaka', 'Affiliation': 'Departments of Orthopaedic Surgery (S.T., K.K., M.N., and N.H.) and Anesthesiology (T.M.), Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Departments of Orthopaedic Surgery (S.T., K.K., M.N., and N.H.) and Anesthesiology (T.M.), Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Tetsuyuki', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Departments of Orthopaedic Surgery (S.T., K.K., M.N., and N.H.) and Anesthesiology (T.M.), Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirasawa', 'Affiliation': 'Departments of Orthopaedic Surgery (S.T., K.K., M.N., and N.H.) and Anesthesiology (T.M.), Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Matsue', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University, Tokyo, Japan.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01083']
184,31366975,"Defibrotide enhances fibrinolysis in human endotoxemia - a randomized, double blind, crossover trial in healthy volunteers.","Defibrotide is approved for the treatment of sinusoidal obstruction syndrome after allogeneic stem cell transplantation. The exact mode of action of defibrotide is unclear and human in vivo data are scarce. In this randomized, double blind, crossover trial we included 20 healthy volunteers. Four were randomized to receive placebo, while 16 received a 2 ng/kg bodyweight bolus of lipopolysaccharide (LPS). Infusion of 6.25 mg/kg defibrotide or placebo was started one hour before the injection of the LPS bolus. Plasma levels of prothrombin fragments F1 + 2, thrombin-antithrombin complexes, von Willebrand factor, E-selectin, tissue-type plasminogen activator (t-PA), plasminogen activator inhibitor-1 (PAI-1), plasmin-antiplasmin complexes (PAP), tumor necrosis factor-α, interleukin 6, and C-reactive protein were measured. Thromboelastometry was performed. Infusion of defibrotide did not reduce the LPS-induced activation of coagulation, the endothelium or the release of pro-inflammatory cytokines. However, defibrotide increased t-PA antigen levels by 31% (Quartiles: 2-49%, p = 0.026) and PAP concentrations by 13% (-4-41%, p = 0.039), while PAI-1 levels remained unaffected. Moreover, defibrotide reduced C-reactive protein levels by 13% (0-17%, p = 0.002). A transient increase in the clotting time in thromboelastometry and a decrease in F1 + 2 prothrombin fragments suggests modest anticoagulant properties. In conclusion, defibrotide infusion enhanced fibrinolysis and reduced C-reactive protein levels during experimental endotoxemia.",2019,"Infusion of defibrotide did not reduce the LPS-induced activation of coagulation, the endothelium or the release of pro-inflammatory cytokines.","['human endotoxemia ', '20 healthy volunteers', 'sinusoidal obstruction syndrome after allogeneic stem cell transplantation', 'healthy volunteers']","['defibrotide', 'defibrotide or placebo', 'placebo', 'lipopolysaccharide (LPS', 'Defibrotide']","['fibrinolysis and reduced C-reactive protein levels', 'PAI-1 levels', 'PAI-1), plasmin-antiplasmin complexes (PAP', 'Plasma levels of prothrombin fragments F1\u2009+\u20092, thrombin-antithrombin complexes, von Willebrand factor, E-selectin, tissue-type plasminogen activator (t-PA), plasminogen activator inhibitor-1', 'defibrotide reduced C-reactive protein levels', 'PAP concentrations', 'clotting time', 'LPS-induced activation of coagulation, the endothelium or the release of pro-inflammatory cytokines', 't-PA antigen levels', ' tumor necrosis factor-α, interleukin 6, and C-reactive protein']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019156', 'cui_str': 'Sinusoidal Obstruction Syndrome'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}]","[{'cui': 'C0057257', 'cui_str': 'defibrotide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C0003410', 'cui_str': 'alpha 2-Plasmin Inhibitor'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0057257', 'cui_str': 'defibrotide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0430420', 'cui_str': 'Antigen level'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",20.0,0.360124,"Infusion of defibrotide did not reduce the LPS-induced activation of coagulation, the endothelium or the release of pro-inflammatory cytokines.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoergenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Buchtele', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gelbenegger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Katarina D', 'Initials': 'KD', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwameis', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Wohlfarth', 'Affiliation': 'Department of Blood and Bone Marrow Transplantation, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Rabitsch', 'Affiliation': 'Department of Blood and Bone Marrow Transplantation, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Wien, Austria. Bernd.jilma@meduniwien.ac.at.'}]",Scientific reports,['10.1038/s41598-019-47630-6']
185,31366977,Pyrosequencing versus methylation-specific PCR for assessment of MGMT methylation in tumor and blood samples of glioblastoma patients.,"Circulating biomarkers in blood may provide an interesting alternative to risky tissue biopsies in the diagnosis and follow-up of glioblastoma patients. We have assessed MGMT methylation status in blood and tissue samples from unresected glioblastoma patients who had been included in the randomized GENOM-009 trial. Paired blood and tissue samples were assessed by methylation-specific PCR (MSP) and pyrosequencing (PYR). After establishing the minimum PYR cut-off that could yield a significant difference in overall survival, we assessed the sensitivity, specificity, positive predictive value and negative predictive value (NPV) of the analyses. Methylation could be detected in cfDNA by both MSP and PYR but with low concordance with results in tissue. Sensitivity was low for both methods (31% and 38%, respectively), while specificity was higher for MSP in blood than for PYR in plasma (96% vs 76%) and NPV was similar (56 vs 57%). Concordance of results in tissue by MSP and PYR was 84.3% (P < 0.001) and correlated with outcome. We conclude that detection of cfDNA in the blood of glioblastoma patients can be an alternative when tumor tissue is not available but methods for the detection of cfDNA in blood must improve before it can replace analysis in tumor tissue.",2019,Concordance of results in tissue by MSP and PYR was 84.3% (P < 0.001) and correlated with outcome.,"['glioblastoma patients', 'unresected glioblastoma patients who had been included in the randomized GENOM-009 trial']",[],"['methylation-specific PCR (MSP) and pyrosequencing (PYR', 'sensitivity, specificity, positive predictive value and negative predictive value (NPV', 'Sensitivity', 'overall survival']","[{'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C2732543', 'cui_str': 'Pyrosequencing'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0976339,Concordance of results in tissue by MSP and PYR was 84.3% (P < 0.001) and correlated with outcome.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Estival', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology Badalona, Hospital Germans Trias i Pujol, Applied Research Group in Oncology (B-ARGO Group), Badalona, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sanz', 'Affiliation': 'Pathology Service, University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Jose-Luis', 'Initials': 'JL', 'LastName': 'Ramirez', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology Badalona, Hospital Germans Trias i Pujol, Applied Research Group in Oncology (B-ARGO Group), Badalona, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Velarde', 'Affiliation': 'Statistical Unit, Applied Research Group in Oncology (B-ARGO Group), Institut Investigació Germans Trias i Pujol (IGTP), Badalona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Domenech', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology Badalona, Hospital Germans Trias i Pujol, Applied Research Group in Oncology (B-ARGO Group), Badalona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carrato', 'Affiliation': 'Pathology Service, University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'de Las Peñas', 'Affiliation': 'Medical Oncology Service, Hospital Provincial de Castellón, Castellón, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Medical Oncology Service, Catalan Institute of Oncology l'Hospitalet de LLobregat, Bellvitge Biomedical Research Institute (IDIBELL) l'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sepúlveda', 'Affiliation': 'Medical Oncology Service, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Armengol', 'Affiliation': 'Neurosurgery Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Cardiel', 'Affiliation': 'Neurosurgery Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Berrocal', 'Affiliation': 'Medical Oncology Service, University Hospital General de Valencia, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Luque', 'Affiliation': 'Medical Oncology Service, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Herrero', 'Affiliation': 'Medical Oncology Service, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Balana', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology Badalona, Hospital Germans Trias i Pujol, Applied Research Group in Oncology (B-ARGO Group), Badalona, Spain. cbalana@iconcologia.net.'}]",Scientific reports,['10.1038/s41598-019-47642-2']
186,32199184,A randomized controlled trial of social skills training for patients with treatment-resistant schizophrenia with predominantly negative symptoms.,"We conducted a randomized controlled trial to assess the effectiveness of social skills training (SST) in improving negative symptoms in patients with treatment-resistant schizophrenia with predominantly negative symptoms. Patients were randomized to receive SST (n = 29) or to a control group (n = 33), in a 20-week program with weekly group sessions. Patients were assessed at baseline, post-treatment (20 weeks) and 6-month follow-up with the Positive and Negative Syndrome Scale. There was no significant improvement in the negative symptoms in either group, at any timepoint. Caution is warranted to interpret the results due to small sample size.",2020,"There was no significant improvement in the negative symptoms in either group, at any timepoint.",['patients with treatment-resistant schizophrenia with predominantly negative symptoms'],"['social skills training', 'social skills training (SST', 'SST']",['negative symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0532207,"There was no significant improvement in the negative symptoms in either group, at any timepoint.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kayo', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil. Electronic address: monica.kayo@gmail.com.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Scemes', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Mariangela Gentil', 'Initials': 'MG', 'LastName': 'Savoia', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bichuette', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Ana Claudia', 'Initials': 'AC', 'LastName': 'Abreu', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Emily Pereira', 'Initials': 'EP', 'LastName': 'da Silva', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Baria', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Piovaccari', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Petreche', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Rodrigo Affonseca', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Gadelha', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Elkis', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil. Electronic address: helkis@usp.br.'}]",Psychiatry research,['10.1016/j.psychres.2020.112914']
187,31267695,Effects of the Girls on the Move randomized trial on adiposity and aerobic performance (secondary outcomes) in low-income adolescent girls.,"BACKGROUND


Limited, mixed evidence exists regarding the effectiveness of physical activity interventions on adiposity and aerobic performance in adolescent underrepresented populations.
OBJECTIVE


To examine effects of Girls on the Move on body mass index z-scores (BMI-z), percent (%) body fat, and aerobic performance in fifth- to eighth-grade underrepresented girls.
METHODS


A group randomized trial, involving 12 intervention and 12 control schools in low-income areas, was conducted. Participants (n = 1519) were low-active girls. The 17-week intervention included (a) a physical activity club, (b) two motivational interviewing sessions, and (c) one Internet-based session. BMI-z was determined from measured height and weight; % body fat was assessed using bioelectric impedance. Aerobic performance was assessed using a shuttle run. Demographics, physical activity (accelerometer), and pubertal development were assessed. Linear mixed models, adjusting for baseline, were used to examine group differences in postintervention.
RESULTS


No significant between-group differences in BMI-z existed at postintervention, but % body fat increased less among intervention than control group girls (M change  = 0.43% vs 0.73%). Aerobic performance decreased less in intervention vs control (M change  = -0.39 vs -0.57).
CONCLUSIONS


Although the intervention positively impacted % body fat and aerobic performance in underrepresented girls, more research is necessary to determine optimal implementation for yielding greater effects.",2019,"Aerobic performance decreased less in intervention vs control (M change  = -0.39 vs -0.57).
","['Participants (n = 1519) were low-active girls', '12 intervention and 12 control schools in low-income areas, was conducted', 'underrepresented girls', 'low-income adolescent girls', 'adolescent underrepresented populations']","['physical activity interventions', 'physical activity club, (b) two motivational interviewing sessions, and (c) one Internet-based session']","['body mass index z-scores (BMI-z), percent (%) body fat, and aerobic performance', 'body fat and aerobic performance', 'BMI-z', 'adiposity and aerobic performance', 'Aerobic performance', 'Demographics, physical activity (accelerometer), and pubertal development']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0243107', 'cui_str': 'development'}]",1519.0,0.0280383,"Aerobic performance decreased less in intervention vs control (M change  = -0.39 vs -0.57).
","[{'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Dhruv B', 'Initials': 'DB', 'LastName': 'Sharma', 'Affiliation': 'Center for Statistical Training and Consulting, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Dalimonte-Merckling', 'Affiliation': 'Human Development and Family Studies, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Vicki R', 'Initials': 'VR', 'LastName': 'Voskuil', 'Affiliation': 'Department of Nursing, Hope College, Holland, Michigan.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Center for Growth and Development, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan.'}]",Pediatric obesity,['10.1111/ijpo.12559']
188,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
189,32305105,"Reverse shoulder arthroplasty with and without latissimus and teres major transfer for patients with combined loss of elevation and external rotation: a prospective, randomized investigation.","BACKGROUND


Latissimus dorsi (LD) and teres major (TM) tendon transfers have been performed concurrently with reverse shoulder arthroplasty (RSA) to address combined loss of elevation and external rotation (CLEER) at the shoulder. The purpose of this prospective, randomized study was to compare RSA with and without LD-TM tendon transfer in patients with rotator cuff tear arthropathy and CLEER.
METHODS


Patients undergoing RSA for rotator cuff tear arthropathy who also had CLEER were randomized into the group undergoing RSA with tendon transfer or the group undergoing RSA without tendon transfer. The primary outcome measure was the Activities of Daily Living and External Rotation (ADLER) score 2 years after surgery. Secondary outcome measures included the Disabilities of the Arm, Shoulder and Hand (DASH) score, American Shoulder and Elbow Surgeons (ASES) score, and Simple Shoulder Test (SST) score.
RESULTS


Both the treatment and control groups showed significant improvements in the ability to perform activities of daily living requiring active external rotation measured by the ADLER score postoperatively. No significant difference in the ADLER, DASH, ASES, or SST score was found between the 2 groups at final follow-up. Resolution of the Hornblower sign occurred postoperatively in 58.3% of patients in the control group and 73.3% of those in the treatment group.
CONCLUSION


No differences in the ADLER, DASH, ASES, and SST results were found between patients treated with RSA alone and those treated with RSA with LD-TM transfer for rotator cuff tear arthropathy and CLEER. Both groups showed significant improvements in all clinical outcome assessments including functional tasks that require active external rotation.",2020,"No differences in the ADLER, DASH, ASES, and SST results were found between patients treated with RSA alone and those treated with RSA with LD-TM transfer for rotator cuff tear arthropathy and CLEER.","['Patients undergoing RSA for rotator cuff tear arthropathy who also had CLEER', 'patients with combined loss of elevation and external rotation', 'patients with rotator cuff tear arthropathy and CLEER']","['shoulder arthroplasty with and without latissimus', 'RSA with tendon transfer or the group undergoing RSA without tendon transfer', 'RSA with and without LD-TM tendon transfer', 'RSA with LD-TM transfer', 'RSA']","['functional tasks that require active external rotation', 'ADLER, DASH, ASES, and SST results', 'ability to perform activities of daily living requiring active external rotation', 'Disabilities of the Arm, Shoulder and Hand (DASH) score, American Shoulder and Elbow Surgeons (ASES) score, and Simple Shoulder Test (SST) score', 'ADLER, DASH, ASES, or SST score', 'Resolution of the Hornblower sign', 'Activities of Daily Living and External Rotation (ADLER) score 2 years after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0409860', 'cui_str': 'Rotator cuff tear arthropathy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0039505', 'cui_str': 'Transfer of tendon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224362', 'cui_str': 'Structure of latissimus dorsi muscle'}, {'cui': 'C0456765', 'cui_str': 'Teres'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242619', 'cui_str': 'Manduca sexta'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0522056,"No differences in the ADLER, DASH, ASES, and SST results were found between patients treated with RSA alone and those treated with RSA with LD-TM transfer for rotator cuff tear arthropathy and CLEER.","[{'ForeName': 'Bradley L', 'Initials': 'BL', 'LastName': 'Young', 'Affiliation': 'Department of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, Charlotte, NC, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Connor', 'Affiliation': 'OrthoCarolina Shoulder and Elbow Center, Charlotte, NC, USA; OrthoCarolina Sports Medicine Center, Charlotte, NC, USA.'}, {'ForeName': 'Shadley C', 'Initials': 'SC', 'LastName': 'Schiffern', 'Affiliation': 'OrthoCarolina Shoulder and Elbow Center, Charlotte, NC, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Roberts', 'Affiliation': 'OrthoCarolina Research Institute, Charlotte, NC, USA.'}, {'ForeName': 'Nady', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': 'OrthoCarolina Shoulder and Elbow Center, Charlotte, NC, USA. Electronic address: Nady.Hamid@OrthoCarolina.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.12.024']
190,32305106,Tranexamic acid for the Latarjet procedure: a randomized controlled trial.,"BACKGROUND


Tranexamic acid (TXA) is commonly used in orthopedic surgery to reduce perioperative bleeding and the need for transfusion. The purpose of the study was to assess whether TXA could reduce the incidence of postoperative swelling and hematoma formation and pain and opioid use in the early postoperative period following the Latarjet procedure.
METHODS


A randomized controlled trial was conducted in 100 patients undergoing open Latarjet surgery for anterior shoulder instability by a single surgeon. Patients were randomized to receive either 1 g TXA or a placebo intravenously preoperatively. Outcomes measured during the perioperative period were (1) intraoperative blood loss, (2) postoperative blood loss (via drain output), (3) postoperative swelling/hematoma formation, (4) visual analog scale (VAS) score, and (5) postoperative opioid use (in morphine milligram equivalents).
RESULTS


There was no significant difference in intraoperative blood loss (60.9 vs. 68.9 mL, P = .18). However, there was significantly lower postoperative blood loss with TXA (29.6 vs. 64.9 mL, P < .01). There was a significantly lower rate of painful postoperative swelling (4% vs. 32%, P < .01). Additionally, we found a significantly lower VAS score for pain (1.7 vs. 3.0, P < .01) and significantly less postoperative opioid use (9.4 vs. 22 mg, P < .01) in the TXA group. Postoperative swelling was shown to correlate with increased pain and opioid use (P < .01).
CONCLUSION


Our study found that TXA significantly reduced postoperative blood loss, painful postoperative swelling, and hematoma formation and subsequently reduced postoperative pain and opioid use following the Latarjet procedure.",2020,"There was a significantly lower rate of painful postoperative swelling (4% vs. 32%, P < .01).",['100 patients undergoing open Latarjet surgery for anterior shoulder instability by a single surgeon'],"['TXA', 'Tranexamic acid', 'Tranexamic acid (TXA', 'placebo']","['Postoperative swelling', 'intraoperative blood loss, (2) postoperative blood loss (via drain output), (3) postoperative swelling/hematoma formation, (4) visual analog scale (VAS) score, and (5) postoperative opioid use (in morphine milligram equivalents', 'VAS score for pain', 'postoperative blood loss, painful postoperative swelling, and hematoma formation', 'postoperative blood loss', 'rate of painful postoperative swelling', 'postoperative opioid use', 'intraoperative blood loss', 'pain and opioid use']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.295491,"There was a significantly lower rate of painful postoperative swelling (4% vs. 32%, P < .01).","[{'ForeName': 'Eoghan T', 'Initials': 'ET', 'LastName': 'Hurley', 'Affiliation': 'Sports Surgery Clinic, Dublin, Ireland; Royal College of Surgeons in Ireland, Department of Trauma & Orthopaedic Surgery, Dublin, Ireland; National University of Ireland Galway, Galway, Ireland. Electronic address: eoghanhurley@rcsi.ie.'}, {'ForeName': 'Daren', 'Initials': 'D', 'LastName': 'Lim Fat', 'Affiliation': 'Sports Surgery Clinic, Dublin, Ireland.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pauzenberger', 'Affiliation': 'Sports Surgery Clinic, Dublin, Ireland.'}, {'ForeName': 'Hannan', 'Initials': 'H', 'LastName': 'Mullett', 'Affiliation': 'Sports Surgery Clinic, Dublin, Ireland; Royal College of Surgeons in Ireland, Department of Trauma & Orthopaedic Surgery, Dublin, Ireland.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.01.066']
191,31812609,Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial.,"OBJECTIVES


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


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


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


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


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


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


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


Sleep knowledge improved at follow-up in the SEP relative to the HLP group (p = .017).","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'van Rijn', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Shirley Y J', 'Initials': 'SYJ', 'LastName': 'Koh', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Alyssa S C', 'Initials': 'ASC', 'LastName': 'Ng', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Ksenia', 'Initials': 'K', 'LastName': 'Vinogradova', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Nicholas I Y N', 'Initials': 'NIYN', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Su Mei', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gooley', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594. Electronic address: michael.chee@nus.edu.sg.'}]",Sleep health,['10.1016/j.sleh.2019.10.006']
192,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
193,31719073,Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial.,"OBJECTIVES


The Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) Programme was designed to improve confidence and self-efficacy and to reduce burden for support group leaders. Objectives were to (1) evaluate feasibility of programme delivery, including required resources, management issues and scientific aspects (eg, performance of outcome measures) and (2) assess user satisfaction and identify any modifications needed to improve programme content or delivery based on participant feedback.
DESIGN


Non-randomised feasibility trial.
SETTING


North American patient organisations.
PARTICIPANTS


Current support group leaders or potential new leaders referred by patient organisations.
INTERVENTION


The programme included 13 modules delivered live via videoconference over 3 months (April to July 2018) in 60 to 90 min sessions.
OUTCOME MEASURES


(1) Elements of feasibility, including enrolment and consent procedures, percentage of referred group leaders who consented to participate, session attendance and technical support requirements; (2) programme usability, understandability, organisation and clarity; (3) leader satisfaction with the programme and (4) planned trial outcome measures, including support group leader self-efficacy, burnout, emotional distress and physical function.
RESULTS


All 12 referred potential participants consented to enrol, and 10 were included in two training groups of five participants each. Participants attended 95% of sessions. Required technical support was minimal, and videoconferencing technology functioned well. Overall programme satisfaction rating was 9.4/10. Mean item rating on the eight items of the Client Satisfaction Questionnaire-8 was 3.83 (1=low satisfaction; 4=high satisfaction). Pre-post scores on the Scleroderma Support Group Leader Self-efficacy Scale increased by 1.7 SDs (large effect); scores on burnout, emotional distress and physical function improved by 0.44, 0.38 and 0.45 SDs (moderate effects).
CONCLUSION


The SPIN-SSLED Programme was feasibly delivered, including management, resource and scientific aspects. Participant satisfaction was high. The programme is ready to be tested in a full-scale randomised controlled trial.
TRIAL REGISTRATION NUMBER


NCT03508661.",2019,"Pre-post scores on the Scleroderma Support Group Leader Self-efficacy Scale increased by 1.7 SDs (large effect); scores on burnout, emotional distress and physical function improved by 0.44, 0.38 and 0.45 SDs (moderate effects).
","['Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation', 'All 12 referred potential participants consented to enrol, and 10 were included in two training groups of five participants each', 'North American patient organisations']","['Scleroderma Support group Leader EDucation (SPIN-SSLED', 'Current support group leaders or potential new leaders referred by patient organisations', 'live via videoconference']","['confidence and self-efficacy', 'Leader Self-efficacy Scale', 'Mean item rating', '1) Elements of feasibility, including enrolment and consent procedures, percentage of referred group leaders who consented to participate, session attendance and technical support requirements; (2) programme usability, understandability, organisation and clarity; (3) leader satisfaction with the programme and (4) planned trial outcome measures, including support group leader self-efficacy, burnout, emotional distress and physical function', 'required resources, management issues and scientific aspects (eg, performance of outcome measures) and (2) assess user satisfaction and identify any modifications needed to improve programme content or delivery based on participant feedback', 'emotional distress and physical function', 'Overall programme satisfaction rating']","[{'cui': 'C0011644', 'cui_str': 'Dermatosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}]","[{'cui': 'C0011644', 'cui_str': 'Dermatosclerosis'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",12.0,0.0814177,"Pre-post scores on the Scleroderma Support Group Leader Self-efficacy Scale increased by 1.7 SDs (large effect); scores on burnout, emotional distress and physical function improved by 0.44, 0.38 and 0.45 SDs (moderate effects).
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada brett.thombs@mcgill.ca.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, Michigan, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Pépin', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Kylene', 'Initials': 'K', 'LastName': 'Aguila', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peláez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sauve', 'Affiliation': 'Scleroderma Society of Ontario, Scleroderma Canada, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Platt', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029935']
194,30886326,Adverse influence of bisoprolol on central blood pressure in the upright position: a double-blind placebo-controlled cross-over study.,"Treatment with beta-blockers is characterized by inferior reduction of central versus peripheral blood pressure. We examined changes in blood pressure, cardiac function, and vascular resistance after 3 weeks of bisoprolol treatment (5 mg/day) during passive head-up tilt in 16 never-treated Caucasian males with grade I-II primary hypertension. A double-blind, randomized, placebo-controlled cross-over design was applied, and hemodynamics were recorded using continuous tonometric pulse wave analysis and whole-body impedance cardiography. Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085). Bisoprolol reduced heart rate and left cardiac work, and increased subendocardial viability index in supine and upright positions (p ≤ 0.044 for all). Bisoprolol increased stroke volume in the supine (~11 ml, p = 0.02) but not in the upright position, while only upright (~1 l/min, p = 0.007) but not supine cardiac output was reduced. Upright elevation in systemic vascular resistance was increased 2.7-fold (p = 0.002), while upright pulse pressure amplification was decreased by ~20% (p = 0.002) after bisoprolol. Aortic augmentation index, augmentation pressure, and pulse pressure were not changed in the supine position but were increased in the upright position (from 9% to 17%, 3-6 mmHg, and 30-34 mmHg, respectively, p ≤ 0.016 for all). In conclusion, although bisoprolol treatment reduced peripheral blood pressure, central systolic blood pressure in the upright position was not decreased. Importantly, the harmful influences of bisoprolol on central pulse pressure and pressure wave reflection were manifested in the upright position.",2020,"Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085).",['16 never-treated Caucasian males with grade I-II primary hypertension'],"['beta-blockers', 'bisoprolol treatment (5\u2009mg/day) during passive head-up tilt', 'bisoprolol', 'placebo']","['blood pressure', 'central pulse pressure and pressure wave reflection', 'central blood pressure', 'supine cardiac output', 'upright aortic systolic blood pressure', 'Bisoprolol increased stroke volume', 'blood pressure, cardiac function, and vascular resistance', 'upright pulse pressure amplification', 'Upright elevation in systemic vascular resistance', 'Aortic augmentation index, augmentation pressure, and pulse pressure', 'radial artery', 'peripheral blood pressure, central systolic blood pressure', 'upright position', 'Bisoprolol reduced heart rate and left cardiac work, and increased subendocardial viability index']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0520872', 'cui_str': 'Increased cardiac stroke volume (finding)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.133562,"Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085).","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Suojanen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland. lsuojanen@gmail.com.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Haring', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Tikkakoski', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kähönen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Arttu', 'Initials': 'A', 'LastName': 'Eräranta', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Jukka T', 'Initials': 'JT', 'LastName': 'Mustonen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Ilkka H', 'Initials': 'IH', 'LastName': 'Pörsti', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}]",Journal of human hypertension,['10.1038/s41371-019-0188-9']
195,31391479,Association between dynamic resting-state functional connectivity and ketamine plasma levels in visual processing networks.,"Numerous studies demonstrate ketamine's influence on resting-state functional connectivity (rsFC). Seed-based and static rsFC estimation methods may oversimplify FC. These limitations can be addressed with whole-brain, dynamic rsFC estimation methods. We assessed data from 27 healthy subjects who underwent two 3 T resting-state fMRI scans, once under subanesthetic, intravenous esketamine and once under placebo, in a randomized, cross-over manner. We aimed to isolate only highly robust effects of esketamine on dynamic rsFC by using eight complementary methodologies derived from two dynamic rsFC estimation methods, two functionally defined atlases and two statistical measures. All combinations revealed a negative influence of esketamine on dynamic rsFC within the left visual network and inter-hemispherically between visual networks (p < 0.05, corrected), hereby suggesting that esketamine's influence on dynamic rsFC is highly stable in visual processing networks. Our findings may be reflective of ketamine's role as a model for psychosis, a disorder associated with alterations to visual processing and impaired inter-hemispheric connectivity. Ketamine is a highly effective antidepressant and studies have shown changes to sensory processing in depression. Dynamic rsFC in sensory processing networks might be a promising target for future investigations of ketamine's antidepressant properties. Mechanistically, sensitivity of visual networks for esketamine's effects may result from their high expression of NMDA-receptors.",2019,"All combinations revealed a negative influence of esketamine on dynamic rsFC within the left visual network and inter-hemispherically between visual networks (p < 0.05, corrected), hereby suggesting that esketamine's influence on dynamic rsFC is highly stable in visual processing networks.","['27 healthy subjects who underwent two 3\u2009T resting-state fMRI scans, once under subanesthetic, intravenous', 'visual processing networks']","['esketamine', 'esketamine and once under placebo', 'Ketamine']",['resting-state functional connectivity (rsFC'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}]","[{'cui': 'C2825616'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",27.0,0.0647747,"All combinations revealed a negative influence of esketamine on dynamic rsFC within the left visual network and inter-hemispherically between visual networks (p < 0.05, corrected), hereby suggesting that esketamine's influence on dynamic rsFC is highly stable in visual processing networks.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Spies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Höflich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Center of Excellence, Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Michenthaler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Georg S', 'Initials': 'GS', 'LastName': 'Kranz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Center of Excellence, Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. rupert.lanzenberger@meduniwien.ac.at.'}]",Scientific reports,['10.1038/s41598-019-46702-x']
196,31663769,Impact of menopausal hormone formulations on pituitary-ovarian regulatory feedback.,"Changes in pituitary-ovarian hormones across the menopausal transition have multiple physiological consequences. However, little is known about how the major types of postmenopausal hormone therapy (HT) affect pituitary-ovarian hormonal relationships. This study evaluated these relationships in recently menopausal women (52.45 ± 2.49 yr of age) in the Kronos Early Estrogen Prevention Study (KEEPS) who were compliant to randomized, double-blinded treatment with oral conjugated equine estrogen (o-CEE;  n  = 109), transdermal 17β-estradiol (t-E2;  n  = 107), or placebo ( n  = 146). Androstenedione, testosterone, 17β-estradiol, estrone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum before (baseline) and 48 mo after randomization to treatment. Descriptive summaries of hormone levels were performed, and multiple regression analyses were used to examine the effects of o-CEE, t-E2, and placebo on these hormone levels at 48 mo, adjusting for baseline levels. A network analysis examined the covariance of changes in hormone levels over the 48 mo within treatment groups. As expected, at 48 mo of treatment, hormone levels differed between women in the two active treatment groups compared with placebo, and network analysis indicated stronger relationships among hormone levels in the t-E2 and o-CEE groups compared with placebo. Associations among testosterone, 17β-estradiol, FSH, and LH differed between the o-CEE group compared with t-E2 and placebo groups. Thus, two common HT regimens differentially alter pituitary-ovarian hormone levels, altering feedback cycles and interhormonal associations in recently menopausal women. These interactions provide the basis for future studies investigating the impact of hormonal modulation of aging, including cognitive decline in women.",2019,"Associations among testosterone, 17β-estradiol, FSH and LH differed between the o-CEE group compared to t-E2 and placebo groups.","['recently menopausal women (52.45± 2.49 years of age) in the Kronos Early Estrogen Prevention Study (KEEPS', 'women']","['placebo', 'Menopausal Hormone Formulations', 'oral conjugated equine estrogen (o-CEE, n=109), transdermal 17β-estradiol']","['Androstenedione, testosterone, 17β-estradiol, estrone, follicle stimulating hormone (FSH), and luteinizing hormone (LH', 'pituitary-ovarian hormone levels, altering feedback cycles and inter-hormonal associations', 'testosterone, 17β-estradiol, FSH and LH', 'hormone levels']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708661', 'cui_str': '2.49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]","[{'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C4521988', 'cui_str': 'Ovarian hormone (disposition)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.484776,"Associations among testosterone, 17β-estradiol, FSH and LH differed between the o-CEE group compared to t-E2 and placebo groups.","[{'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Kling', 'Affiliation': ""Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, Arizona.""}, {'ForeName': 'N Maritza', 'Initials': 'NM', 'LastName': 'Dowling', 'Affiliation': 'Department of Acute and Chronic Care, School of Nursing, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, Washington, D.C.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Bimonte-Nelson', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Carey E', 'Initials': 'CE', 'LastName': 'Gleason', 'Affiliation': ""Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health and the Wisconsin Alzheimer's Disease Research Center, Madison Veterans Affairs GRECC, Madison, Wisconsin.""}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City, Utah.'}, {'ForeName': 'Rogerio A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Reproductive Endocrinology and Infertility, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Neal-Perry', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, University of Washington, Seattle, Washington.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Naftolin', 'Affiliation': 'Reproductive Biology Research, Department of Obstetrics and Gynecology, New York University, New York, New York.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'The Kronos Longevity Research Institute, Phoenix Veterans Affairs Health Care System, University of Arizona College of Medicine, Phoenix, Arizona.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, Minnesota.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00234.2019']
197,31675420,"Impact of Hormonal Contraceptives on Cervical T-helper 17 Phenotype and Function in Adolescents: Results from a Randomized, Crossover Study Comparing Long-acting Injectable Norethisterone Oenanthate (NET-EN), Combined Oral Contraceptive Pills, and Combined Contraceptive Vaginal Rings.","BACKGROUND


Adolescents in sub-Saharan Africa are at risk for human immunodeficiency virus (HIV) infection and unintended pregnancies. Observational studies suggest that injectable hormonal contraceptives (HCs) increase the HIV risk, although their effects on genital inflammation, particularly HIV-susceptible T-helper 17 (Th17) cells, are unknown. In a randomized crossover study, the effect of injectable norethisterone oenanthate (NET-EN), combined contraceptive vaginal rings (CCVR; NuvaRing), and combined oral contraceptive pills (COCPs) on cervical Th17 cells and cytokines were compared.
METHODS


Adolescents (n = 130; 15-19 years) were randomly assigned 1:1:1 to NET-EN, CCVR, or COCPs for 16 weeks, then subsequently crossed over to another HC for 16 weeks. Estrogen, follicular stimulating hormone (FSH), and luteinizing hormone (LH) levels were measured. Chemokine receptor 5 (CCR5), human leukocyte antigen (HLA) DR isotope, and cluster of differentiation 38 (CD38) expression by cervical cytobrush-derived CD4+ T cells was assessed by fluorescence-activated cell sorting. Th17 cells were defined as CCR6+ and CCR10-. Cervicovaginal Th17-related cytokines were measured by Luminex.
RESULTS


CCVR use for the first 16 weeks was associated with reduced Th17 frequencies and lower FSH and LH concentrations, as compared to NET-EN and COCPs, with FSH concentrations and Th17 frequencies correlating significantly. However, Th17-related cytokine concentrations (interleukin [IL]-21, IL-1β, tumor necrosis factor-α, interferon-γ) and CCR5, HLA-DR, CD38, and Th17 frequencies were significantly higher in CCVR than NET-EN and COCP. At crossover, CCVR users changing to COCPs or NET-EN did not resolve activation or cytokines, although switching from COCP to CCVRs increased cytokine concentrations.
CONCLUSIONS


CCVR use altered endogenous hormone levels and associated cervical Th17 cell frequencies to a greater extent than use of NET-EN or COCPs, although Th17 cells were more activated and Th17-related cytokine concentrations were elevated. While CCVRs may impact the HIV risk by regulating Th17 numbers, increased activation and inflammation may balance any risk gains.",2020,"RESULTS


CCVR use for the first 16-weeks was associated with reduced Th17 frequencies and lower FHS and LH concentrations compared to NET-EN/COCPs, with FHS concentrations and Th17 frequencies correlating significantly.","['adolescents', 'Adolescents (n=130; 15-19 years']","['long-acting injectable norethisterone oenanthate (NET-EN), combined oral contraceptive pills, and combined contraceptive vaginal rings', 'hormonal contraceptives', 'injectable hormonal contraceptives (HC', 'injectable norethisterone oenanthate (NET-EN), combined contraceptive vaginal rings (CCVR; NuvaRing®), and combined oral contraceptive pills (COCPs']","['CCR5, HLA-DR and CD38 expression by cervical cytobrush-derived CD4+ T cells', 'Estrogen (E2), follicular stimulating hormone (FSH), and luteinizing hormone (LH', 'activated and Th17-related cytokine concentrations', 'Cervicovaginal Th17-related cytokines', 'Th17-related cytokine concentrations (IL-21, IL-1β, TNF-α, IFN-γ) and CCR5+HLA-DR+CD38+ Th17 frequencies', 'FHS and LH concentrations', 'endogenous hormone levels']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0068981', 'cui_str': 'norethindrone enanthate'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}]","[{'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0962190', 'cui_str': 'IL-21'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.074477,"RESULTS


CCVR use for the first 16-weeks was associated with reduced Th17 frequencies and lower FHS and LH concentrations compared to NET-EN/COCPs, with FHS concentrations and Th17 frequencies correlating significantly.","[{'ForeName': 'Iyaloo N', 'Initials': 'IN', 'LastName': 'Konstantinus', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Balle', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shameem Z', 'Initials': 'SZ', 'LastName': 'Jaumdally', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hoyam', 'Initials': 'H', 'LastName': 'Galmieldien', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu Human Immunodeficiency Virus Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Masson', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ramla F', 'Initials': 'RF', 'LastName': 'Tanko', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Musalula', 'Initials': 'M', 'LastName': 'Sinkala', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Department of Pathology & Laboratory Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu Human Immunodeficiency Virus Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1063']
198,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
199,31644381,Comparing Traditional and Tablet-Based Intervention for Children With Speech Sound Disorders: A Randomized Controlled Trial.,"Purpose This article reports on the effectiveness of a novel tablet-based approach to phonological intervention and compares it to a traditional tabletop approach, targeting children with phonologically based speech sound disorders (SSD). Method Twenty-two Portuguese children with phonologically based SSD were randomly assigned to 1 of 2 interventions, tabletop or tablet (11 children in each group), and received intervention based on the same activities, with the only difference being the delivery. All children were treated by the same speech-language pathologist over 2 blocks of 6 weekly sessions, for 12 sessions of intervention. Participants were assessed at 3 time points: baseline; pre-intervention, after a 3-month waiting period; and post-intervention. Outcome measures included percentage of consonants correct, percentage of vowels correct, and percentage of phonemes correct. A generalization of target sounds was also explored. Results Both tabletop and tablet-based interventions were effective in improving percentage of consonants correct and percentage of phonemes correct scores, with an intervention effect only evident for percentage of vowels correct in the tablet group. Change scores across both interventions were significantly greater after the intervention, compared to baseline, indicating that the change was due to the intervention. High levels of generalization (60% and above for the majority of participants) were obtained across both tabletop and tablet groups. Conclusions The software proved to be as effective as a traditional tabletop approach in treating children with phonologically based SSD. These findings provide new evidence regarding the use of digital materials in improving speech in children with SSD. Supplemental Material https://doi.org/10.23641/asha.9989816.",2019,"Both tabletop and tablet-based interventions were effective in improving percentage of consonants correct and percentage of phonemes correct scores, with an intervention effect only evident for percentage of vowels correct in the tablet group.","['Children With Speech Sound Disorders', 'children with phonologically based SSD', 'children with phonologically based speech sound disorders (SSD', 'Method Twenty-two Portuguese children with phonologically based SSD', 'children with SSD']","['novel tablet-based approach to phonological intervention', 'Supplemental Material https://doi.org/10.23641/asha.9989816', 'Traditional and Tablet-Based Intervention']","['Change scores', 'High levels of generalization', 'percentage of consonants correct, percentage of vowels correct, and percentage of phonemes correct']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4019167', 'cui_str': 'Phonological Disorder'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0032730', 'cui_str': 'Portuguese (ethnic group)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.0254003,"Both tabletop and tablet-based interventions were effective in improving percentage of consonants correct and percentage of phonemes correct scores, with an intervention effect only evident for percentage of vowels correct in the tablet group.","[{'ForeName': 'Luis M T', 'Initials': 'LMT', 'LastName': 'Jesus', 'Affiliation': 'School of Health Sciences (ESSUA), University of Aveiro, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Institute of Electronics and Informatics Engineering of Aveiro (IEETA), University of Aveiro, Portugal.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': 'Institute of Electronics and Informatics Engineering of Aveiro (IEETA), University of Aveiro, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Mathematics, University of Aveiro, Portugal.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Joffe', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, United Kingdom.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-S-18-0301']
200,32120134,Intraoperative intravenous ibuprofen use is not associated with increased post-tonsillectomy bleeding.,"OBJECTIVES


Intravenous (IV) ibuprofen was approved by the FDA for use in pediatric patients in November 2015. The objective of this study was to compare bleeding rates in pediatric tonsillectomy patients who received intraoperative intravenous ibuprofen versus those who did not. Secondary objectives included analyzing factors that correlated with return to the Emergency Department (ED) for pain or dehydration.
METHODS


Charts were reviewed for all patients 0-18 years of age who underwent a tonsillectomy with or without adenoidectomy at a tertiary care children's hospital from 1/1/2017 through 5/21/2018. Demographic information and perioperative medications including the use of intraoperative intravenous ibuprofen were recorded. ED visits and operating room (OR) returns for bleeding were tracked for up to 30 days after surgery.
RESULTS


1085 charts were analyzed. Intraoperative IV ibuprofen was used in 132 cases (12.2%). Primary bleeds, defined as bleeding within 24 h of surgery, occurred in 1 (0.76%) of 132 patients who received IV ibuprofen, and 1 (0.10%) of 953 patients who did not receive IV ibuprofen. Secondary bleeds, defined as bleeds after 24 h from surgery occurred in 2 (1.52%) of 132 patients who received IV ibuprofen and 38 (3.99%) of 953 patients who did not receive IV ibuprofen. No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
CONCLUSION


The observed bleeding rate after pediatric tonsillectomy was not statistically different in patients who received intraoperative IV ibuprofen versus those who did not receive this medication.
LEVEL OF EVIDENCE


III.",2020,"No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
","['Charts were reviewed for all patients 0-18 years of age who underwent a', 'pediatric patients in November 2015', 'pediatric tonsillectomy patients who received', '1085 charts were analyzed', ""at a tertiary care children's hospital from 1/1/2017 through 5/21/2018""]","['IV ibuprofen', 'ibuprofen', 'tonsillectomy with or without adenoidectomy', 'intraoperative intravenous ibuprofen', 'Intraoperative IV ibuprofen', 'intraoperative IV ibuprofen']","['ED visits and operating room (OR) returns for bleeding', 'bleeding rate', 'bleeding rates', 'bleeds after 24\xa0h from surgery', 'factors that correlated with return to the Emergency Department (ED) for pain or dehydration', 'bleeding within 24\xa0h of surgery', 'rates of overall (primary plus secondary) bleeding requiring return to ED']","[{'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",1085.0,0.0687079,"No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
","[{'ForeName': 'Nikunj K', 'Initials': 'NK', 'LastName': 'Patel', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Sharan J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Nam K', 'Initials': 'NK', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Colorado Hospital, University of Colorado-Denver School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Veronica P', 'Initials': 'VP', 'LastName': 'Carullo', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Yang', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA; Department of Otorhinolaryngology - Head and Neck Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: chyan@montefiore.org.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.109965']
201,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
202,31784432,"Protocol for a double-blind, randomised, placebo-controlled pilot study for assessing the feasibility and efficacy of faecal microbiota transplant in a paediatric Crohn's disease population: PediCRaFT Trial.","INTRODUCTION


Crohn's disease (CD) is a chronic inflammatory condition with transmural involvement of the gastrointestinal tract. Extraintestinal manifestations are common, and the disease burden on patients and the healthcare system is significant. While treatment options have expanded in recent years, they have mainly focused on dampening the immune response, thus carrying notable risks associated with long-term immunosuppression. Faecal microbiota transplant (FMT) targets inflammatory bowel disease (IBD) by modifying intestinal dysbiosis. Limited adult and paediatric data have demonstrated a favourable response to FMT in IBD; however, no randomised controlled trial has yet been published in paediatrics. This double-blind, randomised, placebo-controlled pilot study will assess feasibility and efficacy outcomes of FMT in a paediatric CD population.
METHODS AND ANALYSIS


Forty-five patients between the ages of 3 and 17 years, with established CD or IBD unclassified, will be enrolled 2:1 to undergo FMT intervention or placebo control. Participants will undergo a colonoscopic infusion to the terminal ileum at baseline, followed by oral capsules two times per week for 6 weeks. Outcomes will be measured throughout the intervention period and 18 weeks of subsequent follow-up. Primary outcomes will assess feasibility, including patient recruitment, sample collection and rates of adverse events. Secondary outcomes will address clinical efficacy, including change in clinical response, change in urine metabolome and change in microbiome.
ETHICS AND DISSEMINATION


Ethics approval from the local hospital research ethics board was obtained at the primary site (McMaster Children's Hospital, Hamilton), with ethics pending at the secondary site (Centre Hospitalier Universitaire-Sainte-Justine, Montréal). RBX7455 and RBX2660 are human donor-sourced, microbiota-based therapeutic formulations. Both RBX7455 and RBX2660 are currently undergoing clinical trials to support potential US Food and Drug Administration approval. Approval to conduct this paediatric clinical trial was obtained from Health Canada's Biologics and Genetic Therapies Directorate. The results of this trial will be published in peer-reviewed journals and will help inform a large, multicentre trial in the future.
TRIAL REGISTRATION NUMBER


NCT03378167; pre-results.",2019,Both RBX7455 and RBX2660 are currently undergoing clinical trials to support potential US Food and Drug Administration approval.,"['Forty-five patients between the ages of 3 and 17 years, with established CD or IBD unclassified, will be enrolled 2:1 to undergo', ""paediatric Crohn's disease population""]","['FMT intervention or placebo control', 'RBX7455 and RBX2660', 'placebo', 'FMT', 'faecal microbiota transplant']","['clinical efficacy, including change in clinical response, change in urine metabolome and change in microbiome', 'feasibility, including patient recruitment, sample collection and rates of adverse events', 'feasibility and efficacy']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",45.0,0.640522,Both RBX7455 and RBX2660 are currently undergoing clinical trials to support potential US Food and Drug Administration approval.,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Pai', 'Affiliation': 'Pediatrics, Division of Pediatric Gastroenterology and Nutrition, McMaster University, Hamilton, Ontario, Canada pain@mcmaster.ca.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Popov', 'Affiliation': 'Pediatrics, Division of Pediatric Gastroenterology and Nutrition, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Pediatrics, Division of Pediatric Gastroenterology and Nutrition, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hartung', 'Affiliation': 'Pediatrics, Division of Pediatric Gastroenterology and Nutrition, McMaster University, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-030120']
203,31784433,"Effectiveness of Xin Jia Xuan Bai Cheng Qi Decoction in treating acute exacerbation of chronic obstructive pulmonary disease: study protocol for a multicentre, randomised, controlled trial.","INTRODUCTION


Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) brings a serious impact on patients' quality of life, and has extremely high morbidity and mortality worldwide. Although there are many therapies being developed to alleviate symptoms and reduce mortality, a few studies have supported which treatment method is the best. Traditional Chinese medicine (TCM) has shown good potential in the prevention and treatment of AECOPD, especially in terms of supplementation and reduction of dosage and adverse effect of Western medicine. The purpose of this study is to compare the effectiveness of combination of TCM and Western medicine with conventional therapy alone for AECOPD, and to ensure whether the combined therapy may reduce the use of systemic glucocorticoid in AECOPD without influencing efficacy.
METHODS AND ANALYSIS


A multicentre, randomised, double-blind, placebo-controlled study was conducted to enrol a total of 360 eligible patients who will be randomised into integrated Chinese and Western medicine group A, B and Western standard Medicine group C. After 5 days of intervention and 1 month of follow-up, the efficacy and safety of Xin Jia Xuan Bai Cheng Qi Decoction in patients with AECOPD will be observed. The results of evaluation indicators include: clinical symptoms, biochemical indicators such as blood gas analysis, inflammatory markers, hospitalisation time, TCM syndrome evaluation, biological indicators such as airway, intestinal flora sequencing.
ETHICS AND DISSEMINATION


This trail has been approved by the Ethics Committee of China-Japan Friendship Hospital. The results will be disseminated in international peer-reviewed journals and be presented in academic conferences. The results will also be disseminated to patients by telephone, inquiring on patient's poststudy health status during the follow-up.
TRIAL REGISTRATION NUMBER


ChiCTR1800016915.",2019,"Traditional Chinese medicine (TCM) has shown good potential in the prevention and treatment of AECOPD, especially in terms of supplementation and reduction of dosage and adverse effect of Western medicine.","['chronic obstructive pulmonary disease', '360 eligible patients who will be randomised into']","['TCM and Western medicine', 'placebo', 'integrated Chinese and Western medicine group A, B and Western standard Medicine', 'Traditional Chinese medicine (TCM', 'Xin Jia Xuan Bai Cheng Qi Decoction']","['blood gas analysis, inflammatory markers, hospitalisation time, TCM syndrome evaluation, biological indicators such as airway, intestinal flora sequencing']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4505187', 'cui_str': 'Biological Indicator'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}]",360.0,0.20154,"Traditional Chinese medicine (TCM) has shown good potential in the prevention and treatment of AECOPD, especially in terms of supplementation and reduction of dosage and adverse effect of Western medicine.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Graduate School, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hongchun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of TCM Pulmonary Diseases, Center of Respiratory Medicine, China-Japan Friendship Hospital; National Clinical Research Center for Respiratory Diseases, Beijing, China 13701226664@139.com.'}, {'ForeName': 'Demin', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of TCM Pulmonary Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': 'Department of Pulmonary disease, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Zengtao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Hospital Management Office, Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Pulmonary disease, Affiliated Hospital of Tianjin University of TCM, Tianjin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Innovation and Transformation, National Center for Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, Beijing, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Innovation and Transformation, National Center for Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, Beijing, China.""}, {'ForeName': 'Tianhong', 'Initials': 'T', 'LastName': 'Cui', 'Affiliation': 'Department of Medical Science Services, Beijing Qihuang Medicine Clinical Research Center, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Medical Science Services, Beijing Qihuang Medicine Clinical Research Center, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Qijian', 'Initials': 'Q', 'LastName': 'Cheng', 'Affiliation': 'Department of Pulmonary disease, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, China.'}, {'ForeName': 'Erran', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, China Medical University First Hospital, Shenyang, China.'}]",BMJ open,['10.1136/bmjopen-2019-030249']
204,30880289,Oxygen compared to air during exercise training in COPD with exercise-induced desaturation.,"Almost half the patients referred to pulmonary rehabilitation with chronic obstructive pulmonary disease (COPD) desaturate during exercise. Although oxygen supplementation may ameliorate oxygen desaturation, the effects on outcomes of exercise training have not been rigorously evaluated. This study aimed to determine whether supplemental oxygen during exercise training was more effective than medical air in improving exercise capacity and health-related quality of life (HRQoL) in people with COPD.People with COPD who demonstrated oxygen desaturation <90% during the 6-min walk test were recruited to this multicentre trial with randomisation (independent, concealed allocation) to either an Oxygen group or Air group, blinding (participants, exercise trainers and  European Respiratory Journal  assessors) and intention-to-treat analysis. Both groups received the respective gas from concentrators  via  nasal prongs at 5 L·min -1  during exercise training consisting of treadmill and cycle exercise, three times per week for 8 weeks. Primary outcomes were the endurance shuttle walk test (ESWT) time and Chronic Respiratory Disease Questionnaire (CRQ)-Total score.111 participants (60 males), mean±sd age 69±7 years, with moderate to severe COPD were recruited and 97 completed (Oxygen group n=52; Air group n=45). At the end of the 8-week training programme there were no between-group differences in change in ESWT (mean difference 15 s (95% CI -106-136 s) or change in CRQ-Total (0.0 points (95% CI -0.3-0.3 points)). Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.",2019,"Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.","['people with COPD.People with COPD who demonstrated oxygen desaturation <90% during the 6-min walk test', 'CRQ)-Total score.111 participants (60 males), mean±sd age 69±7 years, with moderate to severe COPD were recruited and 97 completed (Oxygen group n=52; Air group n=45', 'patients referred to pulmonary rehabilitation with chronic obstructive pulmonary disease (COPD) desaturate during exercise']","['oxygen supplementation', 'Oxygen compared to air during exercise training', 'respective gas from concentrators  via  nasal prongs at 5\u2005L·min -1  during exercise training consisting of treadmill and cycle exercise', 'supplemental oxygen during exercise training', 'Oxygen group or Air group, blinding (participants, exercise trainers and  European Respiratory Journal  assessors) and intention-to-treat analysis']","['exercise capacity and health-related quality of life (HRQoL', 'endurance shuttle walk test (ESWT) time and Chronic Respiratory Disease Questionnaire', 'change in ESWT', 'CRQ-Total', 'ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs (physical object)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1960627', 'cui_str': 'Endurance Shuttle Walk Test'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.132649,"Within-group changes at end-training were significant for ESWT and CRQ-Total (all p<0.01).Exercise capacity and HRQoL improved in both groups, with no greater benefit from training with supplemental oxygen than medical air.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Zoe J', 'Initials': 'ZJ', 'LastName': 'McKeough', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Regina W M', 'Initials': 'RWM', 'LastName': 'Leung', 'Affiliation': 'Dept of Physiotherapy, Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Discipline of Physiotherapy, School of Allied Health, LaTrobe University, Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Southport, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Lissa M', 'Initials': 'LM', 'LastName': 'Spencer', 'Affiliation': 'Dept of Physiotherapy, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': 'Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Annemarie L', 'Initials': 'AL', 'LastName': 'Lee', 'Affiliation': 'Dept of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Seale', 'Affiliation': 'Dept of Physiotherapy, Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Dept of Physiotherapy, Sir Charles Gardiner Hospital, Perth, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Institute for Breathing and Sleep, Melbourne, Australia.'}]",The European respiratory journal,['10.1183/13993003.02429-2018']
205,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
206,31685500,Yoga and Cardiovascular Health Trial (YACHT): a UK-based randomised mechanistic study of a yoga intervention plus usual care versus usual care alone following an acute coronary event.,"OBJECTIVE


To determine the effects of yoga practice on subclinical cardiovascular measures, risk factors and neuro-endocrine pathways in patients undergoing cardiac rehabilitation (CR) following acute coronary events.
DESIGN


3-month, two-arm (yoga +usual care vs usual care alone) parallel randomised mechanistic study.
SETTING


One general hospital and two primary care CR centres in London. Assessments were conducted at Imperial College London.
PARTICIPANTS


80 participants, aged 35-80 years (68% men, 60% South Asian) referred to CR programmes 2012-2014.
INTERVENTION


A certified yoga teacher conducted yoga classes which included exercises in stretching, breathing, healing imagery and deep relaxation. It was pre-specified that at least 18 yoga classes were attended for inclusion in analysis. Participants and partners in both groups were invited to attend weekly a 6- to 12-week local standard UK National Health Service CR programme.
MAIN OUTCOME MEASURES


(i) Estimated left ventricular filling pressure (E/e'), (ii) distance walked, fatigue and breathlessness in a 6 min walk test, (iii) blood pressure, heart rate and estimated peak VO 2  following a 3 min step-test. Effects on the hypothalamus-pituitary-adrenal axis, autonomic function, body fat, blood lipids and glucose, stress and general health were also explored.
RESULTS


25 participants in the yoga + usual care group and 35 participants in the usual care group completed the study. Following the 3-month intervention period, E/e' was not improved by yoga (E/e': between-group difference: yoga minus usual care:-0.40 (-1.38, 0.58). Exercise testing and secondary outcomes also showed no benefits of yoga.
CONCLUSIONS


In this small UK-based randomised mechanistic study, with 60 completing participants (of whom 25 were in the yoga + usual care group), we found no discernible improvement associated with the addition of a structured 3-month yoga intervention to usual CR care in key cardiovascular and neuroendocrine measures shown to be responsive to yoga in previous mechanistic studies.
TRIAL REGISTRATION NUMBER


NCT01597960; Pre-results.",2019,"Following the 3-month intervention period, E/e' was not improved by yoga (E/e': between-group difference: yoga minus usual care:-0.40 (-1.38, 0.58).","['60 completing participants (of whom 25 were in the yoga + usual care group', '80 participants, aged 35-80 years (68% men, 60% South Asian) referred to CR programmes 2012-2014', 'One general hospital and two primary care CR centres in London', 'patients undergoing cardiac rehabilitation (CR) following acute coronary events', '25 participants in the yoga + usual care group and 35 participants in the usual care group completed the study']","['yoga practice', 'yoga intervention to usual CR care in key cardiovascular and neuroendocrine measures', 'local standard UK National Health Service CR programme', 'two-arm (yoga +usual care vs usual care alone', 'yoga intervention plus usual care versus usual care alone']","[""i) Estimated left ventricular filling pressure (E/e'), (ii) distance walked, fatigue and breathlessness in a 6 min walk test, (iii) blood pressure, heart rate and estimated peak VO 2  following a 3 min step-test"", 'hypothalamus-pituitary-adrenal axis, autonomic function, body fat, blood lipids and glucose, stress and general health', 'subclinical cardiovascular measures, risk factors and neuro-endocrine pathways']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0020663', 'cui_str': 'Preoptico-Hypothalamic Area'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",80.0,0.0814254,"Following the 3-month intervention period, E/e' was not improved by yoga (E/e': between-group difference: yoga minus usual care:-0.40 (-1.38, 0.58).","[{'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Tillin', 'Affiliation': 'Department of Population Science and Experimental Medicine, Institute of Cardiovascular Science, University College London, London, UK t.tillin@ucl.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Tuson', 'Affiliation': 'York Hospitals NHS Trust, York, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sowa', 'Affiliation': 'West London Mental Health NHS Trust, Southall, UK.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Chattopadhyay', 'Affiliation': 'Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Shah', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': 'Department of Population Science and Experimental Medicine, Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Population Science and Experimental Medicine, Institute of Cardiovascular Science, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030119']
207,31767581,Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol.,"INTRODUCTION


Heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.
METHODS AND ANALYSIS


HGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout'). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.
TRIAL REGISTRATION NUMBER


ISRCTN10483894.",2019,"Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers).",['HGV drivers will be recruited from a logistics company in the UK'],"['Structured Health Intervention', 'SHIFT intervention or usual-care control', ""SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout"", 'SHIFT programme']","['effectiveness and cost-effectiveness', 'total daily physical activity', ' objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol', 'Quality of life and resources used (eg, general practitioner visits']","[{'cui': 'C0403128', 'cui_str': 'Heavy goods vehicle driver (occupation)'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0185014', 'cui_str': 'Banding'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0034380'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]",,0.187718,"Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers).","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK s.a.clemes@lboro.ac.uk.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Varela Mato', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamer', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nishal', 'Initials': 'N', 'LastName': 'Bhupendra Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030175']
208,31812946,"The effects of a 12-week jump rope exercise program on body composition, insulin sensitivity, and academic self-efficacy in obese adolescent girls.","Background Childhood obesity is strongly associated with the development of cardiovascular disease (CVD). Exercise interventions have been used for obese children and adolescents to prevent the manifestation of CVD risks, such as hypertension and insulin resistance (IR). Additionally, obesity has been shown to be linked to low self-efficacy in adolescents, which has been shown to negatively impact academic performance. Therefore, the purpose of this study was to examine the effects of a 12-week jump rope exercise program on body composition, CVD risk factors, and academic self-efficacy (ASE) in obese adolescent girls with prehypertension. Methods Adolescent girls with prehypertension and obesity (n = 48, age 14-16 years) were randomly assigned to either the jump rope exercise group (EX, n = 24) or the control group (CON, n = 24). Body composition, blood pressure (BP), blood glucose, insulin levels, homeostatic model assessment of insulin resistance (HOMA-IR) (marker of IR), and ASE were assessed before and after 12 weeks of exercise training or control. Results There were significant group × time interactions following the 12-week exercise program for body fat percent, waist circumference (WC), systolic blood pressure (SBP), blood glucose, insulin levels, and HOMA-IR, which were all significantly reduced (p < 0.05). A significant improvement (p <0.05) was observed in task difficulty preference (TDP) and self-regulatory efficacy (SRE) following exercise training. Additionally, ASE was strongly correlated (r = -0.58) with body composition. Conclusions This study provides evidence that jump rope exercise intervention can be a useful therapeutic treatment to improve CVD risk factors and ASE in obese adolescent girls with prehypertension.",2020,A significant improvement (p <0.05) was observed in task difficulty preference (TDP) and self-regulatory efficacy (SRE) following exercise training.,"['obese children and adolescents', 'Methods Adolescent girls with prehypertension and obesity (n\u2009=\u200948, age 14-16 years', 'obese adolescent girls with prehypertension', 'obese adolescent girls']","['jump rope exercise program', 'exercise training or control', 'jump rope exercise group (EX, n\u2009=\u200924) or the control group (CON', 'Exercise interventions', 'jump rope exercise intervention']","['task difficulty preference (TDP) and self-regulatory efficacy (SRE', 'Body composition, blood pressure (BP), blood glucose, insulin levels, homeostatic model assessment of insulin resistance (HOMA-IR) (marker of IR), and ASE', 'body composition, CVD risk factors, and academic self-efficacy (ASE', 'body fat percent, waist circumference (WC), systolic blood pressure (SBP), blood glucose, insulin levels, and HOMA-IR', 'body composition, insulin sensitivity, and academic self-efficacy']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0169919,A significant improvement (p <0.05) was observed in task difficulty preference (TDP) and self-regulatory efficacy (SRE) following exercise training.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University, Gwangju, Republic of Korea.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid Iii', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Noble', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2019-0327']
209,31537107,"Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.","BACKGROUND


Ubrogepant is a novel, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. This trial evaluated the safety and tolerability of ubrogepant, focusing on hepatic safety, when administered intermittently with high-frequency dosing to healthy participants.
METHODS


In this phase 1, multicenter, double-blind, parallel-group trial, healthy adults (age 18-50 years) were randomized 1:1 to placebo or ubrogepant. Ubrogepant was dosed at 100 mg (2 × 50 mg tablets) on 2 consecutive days followed by 2 consecutive days of placebo, alternating for 8 weeks. Primary outcome measures were safety and tolerability.
RESULTS


Of participants randomized (n = 518), 516 were included in the safety population (n = 260 placebo; n = 256 ubrogepant). Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants. The most common was headache (10% placebo; 11% ubrogepant). Overall, seven cases of alanine aminotransferase and/or aspartate aminotransferase levels ≥ 3 × the upper limit of normal (five placebo, two ubrogepant) were reported and adjudicated by a panel of independent liver experts blinded to treatment. Four cases were judged unlikely related to treatment. Two cases (one placebo, one ubrogepant) were judged possibly related, and one (ubrogepant) probably related. Alanine aminotransferase increases to ≥ 3 × the upper limit of normal in the two ubrogepant cases (possibly or probably related) were transient and resolved with continued dosing; both cases were asymptomatic, with no concurrent bilirubin elevation.
CONCLUSION


Ubrogepant was well tolerated following intermittent, high-frequency dosing in healthy participants, with no clinically relevant signal of hepatotoxicity.
TRIAL REGISTRATION


NA.",2019,Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants.,"['healthy adults (age 18-50 years', ' 516 were included in the safety population (n\u2009=\u2009260 placebo; n\u2009=\u2009256 ubrogepant', 'Of participants randomized (n\u2009=\u2009518', 'healthy participants', 'healthy adults']","['placebo', 'placebo or ubrogepant']","['alanine aminotransferase and/or aspartate aminotransferase levels', 'headache', 'Alanine aminotransferase', 'Safety and tolerability', 'safety and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",516.0,0.558061,Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Watkins', 'Affiliation': 'Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Girma', 'Initials': 'G', 'LastName': 'Ayele', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Severt', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419869918']
210,31748290,"Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands.","INTRODUCTION


Periconception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth. Lifestyle interventions during pregnancy have resulted in insufficient effects on reducing these perinatal complications. A few reasons for this disappointing effect can be suggested: (1) the time period during pregnancy for improvement of developmental circumstances is too short; (2) the periconception period in which complications originate is not included; and (3) lifestyle interventions may not have been sufficiently multidisciplinary and customised. A preconception lifestyle intervention might be more effective to reduce perinatal complications. Therefore, the aim of the Towards Prepared mums study is to evaluate the effect of a lifestyle intervention starting prior to conception on lifestyle behaviour change.
METHODS AND ANALYSIS


This protocol outlines a non-blinded, randomised controlled trial. One hundred and twelve women (18-40 years of age) with overweight or obesity (body mass index≥25.0 kg/m 2 ) who plan to conceive within 1 year will be randomised to either the intervention or care as usual group. The intervention group will receive a multidisciplinary, customised lifestyle intervention stimulating physical activity, a healthy diet and smoking cessation, if applicable. The lifestyle intervention and monitoring will take place until 12 months postpartum. The primary outcome is difference in weight in kg from baseline to 6 weeks postpartum. Secondary outcomes are gestational weight gain, postpartum weight retention, smoking cessation, dietary and physical activity habits. Furthermore, exploratory outcomes include body composition, cardiometabolic alterations, time to pregnancy, need for assisted reproductive technologies, perinatal complications of mother and child, and lung function of the child. Vaginal and oral swabs, samples of faeces, breast milk, placenta and cord blood will be stored for evaluation of microbial flora, epigenetic markers and breast milk composition. Furthermore, a cost-effectiveness analysis will take place.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Medical Ethical Committee of Maastricht University Medical Centre+ (NL52452.068.15/METC152026). Knowledge derived from this study will be made available by publications in international peer-reviewed scientific journals and will be presented at (inter)national scientific conferences. A dissemination plan for regional and national implementation of the intervention is developed.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02703753.",2019,"INTRODUCTION


Periconception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth.",['One hundred and twelve women (18-40 years of age) with overweight or obesity (body mass'],"['multidisciplinary, customised lifestyle intervention stimulating physical activity, a healthy diet and smoking cessation', 'lifestyle intervention']","['gestational weight gain, postpartum weight retention, smoking cessation, dietary and physical activity habits', 'weight in kg from baseline to 6 weeks postpartum', 'lifestyle behaviour change', 'body composition, cardiometabolic alterations, time to pregnancy, need for assisted reproductive technologies, perinatal complications of mother and child, and lung function of the child']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",112.0,0.154879,"INTRODUCTION


Periconception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth.","[{'ForeName': 'Yvon E G', 'Initials': 'YEG', 'LastName': 'Timmermans', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Kim D G', 'Initials': 'KDG', 'LastName': 'van de Kant', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Reijnders', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Lina M P', 'Initials': 'LMP', 'LastName': 'Kleijkers', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Dompeling', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Boris W', 'Initials': 'BW', 'LastName': 'Kramer', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Luc J I', 'Initials': 'LJI', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Régine P M', 'Initials': 'RPM', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Marc E A', 'Initials': 'MEA', 'LastName': 'Spaanderman', 'Affiliation': 'School for Oncology and Developmental Biology (GROW), Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Anita C E', 'Initials': 'ACE', 'LastName': 'Vreugdenhil', 'Affiliation': 'Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands a.vreugdenhil@mumc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-030236']
211,30414453,Outcomes after Pancreatectomy with Routine Pasireotide Use.,"BACKGROUND


Morbidity after pancreatectomy is commonly due to leakage of exocrine secretions resulting in abscess or pancreatic fistula (PF). Previously, we authored a double-blind randomized controlled trial demonstrating that perioperative pasireotide administration lowers abscess or PF formation by >50%. Accordingly, we adopted pasireotide use as standard practice after pancreatectomy in October 2014 and hypothesized a similar PF/abscess rate reduction would be observed.
STUDY DESIGN


A prospectively maintained database was queried for all patients who underwent pancreatectomy between October 2014 and July 2017. Pasireotide was administered preoperatively and twice daily for 7 days postoperatively or until discharge. The primary end point was clinically relevant PF/abscess requiring procedural intervention, identical to the earlier trial outcomes. Logistic regression was used to compare outcomes with the placebo arm of the earlier randomized trial and to control known PF risk factors.
RESULTS


During the 34-month study period, 652 patients underwent pancreatectomy (211 distal pancreatectomy, 441 pancreaticoduodenectomy). Compared with the historical placebo group (n = 148), the observational group had an increased prevalence of higher American Society of Anesthesiologists scores (69% vs 54%; p < 0.001) and high-risk cases (small duct and soft gland, 47% vs 36%; p = 0.030). The primary end point occurred in 13.3% of patients receiving pasireotide vs 20.9% in the placebo arm of the earlier trial trial (odds ratio 0.58; 95% CI 0.37 to 0.92; p = 0.020). Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged. No subpopulation was identified more likely to benefit from pasireotide.
CONCLUSIONS


At our center, adoption of pasireotide has allowed us to achieve a clinically significant abscess or pancreatic leak rate of 13.3%, approximating the effect observed in the randomized trial of pasireotide during routine surgical practice.",2019,"Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged.","['A prospectively maintained database was queried for all patients who underwent pancreatectomy between October 2014 and July 2017', '652 patients underwent pancreatectomy (211 distal pancreatectomy, 441 pancreaticoduodenectomy']","['historical placebo', 'perioperative pasireotide', 'placebo', 'Pasireotide']","['prevalence of higher American Society of Anesthesiologists scores', 'abscess or PF formation', 'Biliary leakage', 'clinically relevant PF/abscess requiring procedural intervention', 'morbidity']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",652.0,0.323377,"Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kunstman', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Goldman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gönen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Vinod P', 'Initials': 'VP', 'LastName': 'Balachandran', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': ""D'Angelica"", 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'T Peter', 'Initials': 'TP', 'LastName': 'Kingham', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Jarnagin', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Allen', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: allenp@mskcc.org.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2018.10.018']
212,32303373,Effectiveness of a hand hygiene program to reduce acute gastroenteritis at child care centers: A cluster randomized trial.,"We aimed to assess the effectiveness of an educational and hand hygiene program in daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs.
METHODS


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


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


This study demonstrated that hand hygiene programs that included hand sanitizer were most effective in the winter months. Further, the largest reduction of AGE episodes occurred in the children that followed hand hygiene programs including hand sanitizer and educational measures for DCC staff, parents, and children, and were vaccinated for rotavirus.",2020,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","['acute gastroenteritis at child care centers', '911 children aged 0-3 years attending 24 DCCs in Almería (Spain) with an 8-month follow-up was employed', 'daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs']","['DCCs families performed educational and hand hygiene measures, 1 with soap and water (soap and water group; n\u202f=\u202f274), another with hand sanitizer (hand sanitizer group [HSG]; n\u202f=\u202f339), and the control group (CG; n\u202f=\u202f298) followed usual handwashing procedures', 'hand hygiene program', 'educational and hand hygiene program']","['risk of AGE episodes', 'AGE episodes']","[{'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1330330', 'cui_str': 'Hand Antiseptics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",911.0,0.0530918,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","[{'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Azor-Martinez', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain. Electronic address: eazorm@yahoo.es.'}, {'ForeName': 'Llenalia', 'Initials': 'L', 'LastName': 'Garcia-Fernandez', 'Affiliation': 'Deparment of Bioestadistica, SEPLIN, Soluciones Estadísticas, Granada, Spain.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Cantarero-Vallejo', 'Affiliation': 'Castilla-La Mancha Deparment of Health, Centro de salud de Illescas, Toledo, Spain.'}, {'ForeName': 'Carmen Pilar', 'Initials': 'CP', 'LastName': 'Jimenez-Lorente', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Josep Vicent', 'Initials': 'JV', 'LastName': 'Balaguer-Martinez', 'Affiliation': 'Cantalan Deparment of Health, CAP St Ildefons, Cornellà de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Torres-Alegre', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Yui-Hifume', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sanchez-Forte', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gimenez-Sanchez', 'Affiliation': 'Andalusian Deparment of Pediatrics, Instituto Hispalense de Pediatría, Instituto Balmis de Vacunas, Almeria, Spain.'}]",American journal of infection control,['10.1016/j.ajic.2020.03.011']
213,31013363,MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).,"Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor, has been shown to reduce hepatic fat content in patients with primary nonalcoholic fatty liver disease (NAFLD); however, its effect in patients with human immunodeficiency virus (HIV)-associated NAFLD is unknown. The aramchol for HIV-associated NAFLD and lipodystrophy (ARRIVE) trial was a double-blind, randomized, investigator-initiated, placebo-controlled trial to test the efficacy of 12 weeks of treatment with aramchol versus placebo in HIV-associated NAFLD. Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5%, were randomized to receive either aramchol 600 mg daily (n = 25) or placebo (n = 25) for 12 weeks. The primary endpoint was a change in hepatic fat as measured by MRI-PDFF in colocalized regions of interest. Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI. The mean (± standard deviation) of age and body mass index were 48.2 ± 10.3 years and 30.7 ± 4.6 kg/m 2  , respectively. There was no difference in the reduction in mean MRI-PDFF between the aramchol group at -1.3% (baseline MRI-PDFF 15.6% versus end-of-treatment MRI-PDFF 14.4%, P = 0.24) and the placebo group at -1.4% (baseline MRI-PDFF 13.3% versus end-of-treatment MRI-PDFF 11.9%, P = 0.26). There was no difference in the relative decline in mean MRI-PDFF between the aramchol and placebo groups (6.8% versus 1.1%, P = 0.68). There were no differences in MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA. Compared to baseline, end-of-treatment aminotransferases were lower in the aramchol group but not in the placebo arm. There were no significant adverse events. Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition by using MRI-based assessment in patients with HIV-associated NAFLD (clinicaltrials.gov ID:NCT02684591).",2019,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","['Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5', 'patients with primary nonalcoholic fatty liver disease (NAFLD', 'HIV-associated NAFLD']","['placebo', 'Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor', 'aramchol 600 mg daily (n\xa0=\xa025) or placebo', 'aramchol versus placebo', 'Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor']","['hepatic fat or change body fat and muscle composition', 'MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA', 'change in hepatic fat', 'changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI', 'mean (± standard deviation) of age and body mass index', 'mean MRI-PDFF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122583', 'cui_str': '(3beta,5beta,7alpha,12alpha)-7,12-dihydroxy-3-(icosanoylamino)cholan-24-oic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0075202', 'cui_str': 'stearyl-CoA'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1518156', 'cui_str': 'Magnetic Resonance Elastography'}, {'cui': 'C3854624', 'cui_str': 'Vibration controlled transient elastography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1142375', 'cui_str': 'Magnetic resonance imaging of whole body'}, {'cui': 'C0412692', 'cui_str': 'Magnetic resonance imaging of heart'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.376089,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","[{'ForeName': 'Veeral H', 'Initials': 'VH', 'LastName': 'Ajmera', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cachay', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ramers', 'Affiliation': 'Family Health Center, San Diego, CA.'}, {'ForeName': 'Irine', 'Initials': 'I', 'LastName': 'Vodkin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bassirian', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Mangla', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Richele', 'Initials': 'R', 'LastName': 'Bettencourt', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Jeannette L', 'Initials': 'JL', 'LastName': 'Aldous', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Adrija', 'Initials': 'A', 'LastName': 'Mamidipalli', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Boehringer', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Aslam', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Olof Dahlqvist', 'Initials': 'OD', 'LastName': 'Leinhard', 'Affiliation': 'AMRA Medical AB, Linköping, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Sirlin', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30674']
214,32302659,Dextran- Versus Crystalloid-Based Prime in Cardiac Surgery: A Prospective Randomized Pilot Study.,"BACKGROUND


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


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


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


Our results suggest that a hyperoncotic dextran-based priming solution preserves intraoperative colloid oncotic pressure compared with crystalloid prime. Larger studies with clinically valid end points are necessary to evaluate hyperoncotic prime solutions further.",2020,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","['cardiac surgery', 'Eighty cardiac surgery patients']","['Dextran- versus crystalloid-based prime', 'dextran', 'hyperoncotic dextran-based priming solution', 'dextran-based prime or a crystalloid prime containing Ringer acetate and mannitol']","['fluid balance, bleeding and transfusion requirements, pulmonary function, hemolysis, systemic inflammation, and markers of renal, hepatic, myocardial, and brain injury', 'net fluid balance', 'colloid oncotic pressure (COP) in serum during CPB', 'COP', 'CPB', 'intravenous fluid during CPB', 'Plasma free hemoglobin', 'intraoperative COP', 'bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086140', 'cui_str': 'Dextran'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0311418', 'cui_str': 'Oncotic pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0948712', 'cui_str': 'Free plasma haemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",80.0,0.332131,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Barbu', 'Affiliation': 'Department of Cardiology, Blekinge Hospital, Karlskrona, Sweden; Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Kolsrud', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Anesthesiology and Intensive Care, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Björk', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorén', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Hansson', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: anders.jeppsson@vgregion.se.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.031']
215,31825647,Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials.,"Rationale:  Low uptake of low-dose computed tomography (LDCT) lung cancer screening, particularly by current smokers of a low socioeconomic position, compromises effectiveness and equity. Objectives:  To compare the effect of a targeted, low-burden, and stepped invitation strategy versus control on uptake of hospital-based Lung Health Check appointments offering LDCT screening. Methods:  In a two-arm, blinded, between-subjects, randomized controlled trial, 2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ) no prespecified exclusion criteria contraindicating LDCT screening. Both groups received a stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments. The key manipulation was the accompanying leaflet. The intervention group's leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport's annual vehicle test (""M.O.T. For Your Lungs""). Measurements and Main Results:  Uptake was 52.6%, with no difference between intervention (52.3%) and control (52.9%) groups in unadjusted (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.82-1.16) or adjusted (OR, 0.98; 95% CI, 0.82-1.17) analyses. Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers. Socioeconomic deprivation was significantly associated with lower uptake for the control group only ( P  < 0.01). Conclusions:  The intervention did not improve uptake. Regardless of trial arm, uptake was considerably higher than previous clinical and real-world studies, particularly given that the samples were predominantly lower socioeconomic position smokers. Strategies common to both groups, including a Lung Health Check approach, could represent a minimum standard.Clinical trial registered with www.clinicaltrials.gov (NCT02558101) and registered prospectively with the International Standard Registered Clinical/Social Study (N21774741).",2020,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","['Lung Screen Uptake Trial (LSUT', '2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ']","['low-dose computed tomography (LDCT) lung cancer screening', 'stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments', 'intervention group\'s leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport\'s annual vehicle test (""M.O.T. For Your Lungs']","['Socioeconomic deprivation', 'uptake']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",2012.0,0.164682,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McEwen', 'Affiliation': 'National Centre for Smoking Cessation and Training, Dorchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Department of Thoracic Medicine, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0946OC']
216,31424182,Effect of single-session transcranial direct current stimulation on cognition in Parkinson's disease.,"AIMS


Nonmotor symptoms (NMS) such as cognitive impairment and impulse-control disorders in Parkinson's disease (PD) remain a therapeutic challenge. Transcranial direct current stimulation (tDCS) has emerged as a promising alternative, although its immediate effects on NMS have been less well defined. In this randomized, sham-controlled, crossover study, we aimed to explore the single-session tDCS effects on cognitive performance in PD.
METHODS


Ten nondemented patients with PD completed two sessions in counterbalanced order, receiving 20 minutes of either 2 mA anodal or sham tDCS over the left dorsolateral prefrontal cortex (DLPFC). During stimulation, they performed the visual working memory and go/no-go tasks. Performance of the tasks was compared between the two conditions.
RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
CONCLUSION


Single-session tDCS is ineffective in improving visual working memory and inhibitory control in PD. Further research may worth exploring alternative tDCS parameters, ideally with repeated sessions and concomitant training.",2019,"RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
","[""Parkinson's disease (PD"", 'Ten nondemented patients with PD completed two sessions in counterbalanced order', ""Parkinson's disease""]","['single-session transcranial direct current stimulation', 'receiving 20\xa0minutes of either 2\xa0mA anodal or sham tDCS', 'Transcranial direct current stimulation (tDCS']","['cognitive performance', 'cognitive tasks']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],,0.0460988,"RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
","[{'ForeName': 'Chi-Ieong', 'Initials': 'CI', 'LastName': 'Lau', 'Affiliation': 'Dementia Center, Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Mu-N', 'Initials': 'MN', 'LastName': 'Liu', 'Affiliation': 'Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kae-Chwen', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Huey', 'Initials': 'CH', 'LastName': 'Bai', 'Affiliation': 'Department of Public Health, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Shiang', 'Initials': 'CS', 'LastName': 'Tseng', 'Affiliation': 'Department of Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Walsh', 'Affiliation': 'Applied Cognitive Neuroscience Group, Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Han-Cheng', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13210']
217,32301204,"Influence of curcumin on glycemic profile, inflammatory markers, and oxidative stress in HIV-infected individuals: A randomized controlled trial.","To evaluate the influence of curcumin supplementation on the glycemic profile, inflammatory markers, and oxidative stress in HIV-infected individuals under antiretroviral therapy. This double-blind, crossover, randomized clinical trial was composed of 20 subjects arranged initially into experimental group (n = 10) and placebo group (n = 10) groups, receiving 1,000 mg curcumin/day or microcrystalline cellulose/day, respectively, during a 30-day period and 12-day washout. Subsequently, the groups were switched to follow the crossover design. Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured. Food consumption was evaluated as a control variable. Descriptive statistics are presented as mean and standard deviation, and inferential analyses were performed from two-way analysis of variance and the magnitude of the effect. No significant improvements were observed in the glycemic, inflammatory, or oxidative stress profiles. Although the mean serum fasting glucose levels and the homeostatic model assessment index presented qualitative improvement in the CG, this result should be interpreted with caution since the observed variation may represent acceptable fluctuation, in addition to the small difference between the means, added to the large variation observed in the standard deviation. Supplementation with curcumin in HIV-infected individuals undergoing antiretroviral therapy and training did not improve the glycemic, inflammatory, or oxidative stress profiles.",2020,"Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured.","['20 subjects arranged initially into experimental group (n =\u200910) and', 'HIV-infected individuals under antiretroviral therapy', 'HIV-infected individuals undergoing', 'HIV-infected individuals']","['receiving 1,000\u2009mg curcumin/day or microcrystalline cellulose', 'placebo', 'curcumin supplementation', 'curcumin', 'antiretroviral therapy and training']","['Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione', 'glycemic profile, inflammatory markers, and oxidative stress', 'Food consumption', 'mean serum fasting glucose levels', 'glycemic, inflammatory, or oxidative stress profiles']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583334', 'cui_str': 'Serum fasting glucose measurement'}]",,0.057747,"Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured.","[{'ForeName': 'Tatiane A L', 'Initials': 'TAL', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'de Medeiros', 'Affiliation': 'Department of Physical Education, University Center UNIFACEX, Natal, Brazil.'}, {'ForeName': 'Rafaela Catherine', 'Initials': 'RC', 'LastName': 'da Silva Cunha de Medeiros', 'Affiliation': 'Postgraduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Radamés M V', 'Initials': 'RMV', 'LastName': 'Medeiros', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Luanda B F C', 'Initials': 'LBFC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program in Pharmaceutical Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'de Medeiros', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ronaldo V T', 'Initials': 'RVT', 'LastName': 'Dos Santos', 'Affiliation': 'Bioscience Department, Federal University of Sao Paulo, UNIFESP, Santos, Brazil.'}, {'ForeName': 'Phelipe W', 'Initials': 'PW', 'LastName': 'de Alcântara Varela', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Leite-Lais', 'Affiliation': 'Department of Nutrition, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Paulo M S', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6683']
218,32299679,"A multicenter, randomized, placebo-controlled, double-blind phase 3 trial with open-arm comparison indicates safety and efficacy of nephroprotective therapy with ramipril in children with Alport's syndrome.","Children with Alport syndrome develop renal failure early in life. Since the safety and efficacy of preemptive nephroprotective therapy are uncertain we conducted a randomized, placebo-controlled, double-blind trial in 14 German sites of pediatric patients with ramipril for three to six years plus six months follow-up to determine these parameters. Pretreated children and those whose parents refused randomization became an open-arm control, which were compared to prospective real-world data from untreated children. The co-primary endpoints were safety (adverse drug reactions) and efficacy (time to progression). Out of 66 oligosymptomatic children, 22 were randomized and 44 joined the open-arm comparison. Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53). Although not significant, our results cautiously showed that ramipril therapy was effective: in the randomized arm, Ramipril decreased the risk of disease progression by almost half (hazard ratio 0.51 (0.12-2.20)), diminished the slope of albuminuria progression and the decline in glomerular filtration. In adjusted analysis, indications of efficacy were supported by prospective data from participants treated open label compared with untreated children, in whom ramipril again seemed to reduce progression by almost half (0.53 (0.22-1.29)). Incorporating these results into the randomized data by Bayesian evidence synthesis resulted in a more precise estimate of the hazard-ratio of 0.52 (0.19-1.39). Thus, our study shows the safety of early initiation of therapy and supports the hope to slow renal failure by many years, emphasizing the value of preemptive therapy. Hence, screening programs for glomerular hematuria in children and young adults could benefit from inclusion of genetic testing for Alport-related gene-variants.",2020,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"['66 oligosymptomatic children', 'Children with Alport syndrome develop renal failure early in life', 'children and young adults', ""children with Alport's syndrome"", '14 German sites of pediatric patients with ramipril for three to six years plus six months']","['placebo', 'Ramipril', 'ramipril', 'nephroprotective therapy with ramipril', 'preemptive nephroprotective therapy']","['slope of albuminuria progression', 'safety and efficacy', 'safety (adverse drug reactions) and efficacy (time to progression', 'glomerular filtration', 'reduce progression', 'risk of disease progression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C3267042', 'cui_str': 'Nephroprotective therapy'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",66.0,0.200707,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany. Electronic address: gross.oliver@med.uni-goettingen.de.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Lutz T', 'Initials': 'LT', 'LastName': 'Weber', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Latta', 'Affiliation': 'Clementine Kinderhospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fehrenbach', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen, Germany.""}, {'ForeName': 'Baerbel', 'Initials': 'B', 'LastName': 'Lange-Sperandio', 'Affiliation': ""Dr. v. Hauner Children's Hospital, Ludwig Maximilians University, Munich, Germany.""}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Zappel', 'Affiliation': 'Clinic of Pediatrics and Adolescent Medicine, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoyer', 'Affiliation': 'Pediatric Nephrology, Pediatrics II, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Staude', 'Affiliation': ""Pediatric Nephrology, University Children's Hospital Rostock, Rostock, Germany.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'König', 'Affiliation': ""University Children's Hospital Münster, Münster, Germany.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'John', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital, Jena, Germany.""}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gellermann', 'Affiliation': ""Pediatric Nephrology, Charité Children's Hospital, Berlin, Germany.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hoppe', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Galiano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital, Friedrich-Alexander-University Erlangen, Erlangen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hoecker', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Ehren', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lerch', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Kashtan', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boeckhaus', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.12.015']
219,31568683,Episodic memory improvements due to noninvasive stimulation targeting the cortical-hippocampal network: A replication and extension experiment.,"INTRODUCTION


The distributed cortical network of the human hippocampus is important for episodic memory. In a previous experiment, noninvasive stimulation of the hippocampal-cortical network applied for five consecutive days improved paired-associate learning measured after the stimulation regimen via cued recall (Wang et al., Science, 2014, 345, 1054). This finding has not yet been directly replicated. Furthermore, evidence for long-lasting effects of stimulation on paired-associate learning was obtained by analyzing relatively small subsamples (Wang & Voss, Hippocampus, 2015, 25, 877) and requires further evaluation.
METHODS


Sixteen healthy young adults participated in this replication study using the same experimental design as the original study. Participants received 1 week of active stimulation and 1 week of sham stimulation, with memory assessments occurring at the beginning (pre) and end (post) of each week. Assessments included the paired-associate task used in the original study, as well as a long-term episodic memory retention task in order to test the hypothesis that increased paired-associate learning could come at the cost of accelerated long-term forgetting. Change in memory scores was evaluated within (pre vs. post) and across (active vs. sham) weeks.
RESULTS


Similar to Wang et al., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation. We found no evidence that stimulation increased long-term forgetting for either week.
CONCLUSION


These findings confirm the beneficial effects of stimulation on episodic memory that were reported previously and indicate that stimulation-related gains in new learning ability do not come at the price of accelerated long-term forgetting.",2019,"., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation.",['Sixteen healthy young adults participated in this replication study using the same experimental design as the original study'],[],"['paired-associate learning', 'Change in memory scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]",[],"[{'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.0827917,"., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation.","[{'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Hermiller', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Karp', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aneesha S', 'Initials': 'AS', 'LastName': 'Nilakantan', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Voss', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Brain and behavior,['10.1002/brb3.1393']
220,31490300,"Intralesional Triamcinolone May Not Be Beneficial for Treating Acute Hidradenitis Suppurativa Lesions: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


Hidradenitis suppurativa (HS) is a chronic, inflammatory condition characterized by recurrent nodules, sinus tracts, comedones, and scarring. Hidradenitis suppurativa is often associated with pain and decreased quality of life. Limited clinical trial data exist regarding the management of acute HS lesions, but clinical experience and a prospective case series suggest that intralesional triamcinolone may be useful.
OBJECTIVE


To compare the efficacy of intralesional triamcinolone to placebo for the treatment of HS inflammatory lesions.
MATERIALS AND METHODS


This is a double-blind, randomized, placebo-controlled trial comparing intralesional triamcinolone 10 mg/mL, triamcinolone 40 mg/mL, and normal saline (NS). Thirty-two subjects at University of North Carolina Dermatology and Skin Cancer Centers were enrolled for a total of 67 lesions. Subjects reported pain scores, days to resolution, and satisfaction on a standardized survey over a 14-day period.
RESULTS


When intralesional injections of triamcinolone 10 mg/mL, triamcinolone 40 mg/mL, and NS were compared, no significant difference was found for days to HS inflammatory lesion clearance, pain reduction at Day 5, or patient satisfaction.
CONCLUSION


No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions. Steroid injections may be less effective for the management of acute HS than typically presumed.",2020,No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions.,"['Acute Hidradenitis Suppurativa Lesions', 'Thirty-two subjects at University of North Carolina Dermatology and Skin Cancer Centers were enrolled for a total of 67 lesions']","['Placebo', 'Steroid injections', 'intralesional triamcinolone', 'placebo', 'Intralesional Triamcinolone', 'triamcinolone', 'intralesional triamcinolone 10 mg/mL, triamcinolone 40 mg/mL, and normal saline (NS']","['days to HS inflammatory lesion clearance, pain reduction', 'pain scores, days to resolution, and satisfaction', 'quality of life']","[{'cui': 'C0162836', 'cui_str': 'Acne Inversa'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}]",32.0,0.695428,No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions.,"[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Fajgenbaum', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Crouse', 'Affiliation': 'Department of Internal Medicine, Carolinas Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Zeng', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sayed', 'Affiliation': 'Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002112']
221,31650662,Cost-utility of individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy compared with treatment as usual in reducing psychological distress in cancer patients.,"OBJECTIVE


It was previously determined that group-based face-to-face Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) are equally efficacious compared with treatment as usual (TAU) in reducing psychological distress. In this study, the incremental cost-utility of both interventions compared with TAU was assessed.
METHODS


This cost-utility study included 245 self-referred heterogeneous cancer patients with psychological distress who were randomized to MBCT, eMBCT or TAU. Healthcare costs and (informal) work-related productivity losses were assessed by interview. Outcomes were expressed in EuroQol-5D-3L utility scores and quality-adjusted life years (QALY). An economic evaluation with a time-horizon of 3 months was conducted from the societal perspective in the intention-to-treat sample. In addition, secondary explorative analyses of costs and quality of life during the 9-month follow-up were conducted based on linear extrapolation of TAU.
RESULTS


Paid work-related productivity losses and societal costs were lower in both intervention conditions compared with TAU during the 3-month intervention period. Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53). At a willingness to pay of €20000 per QALY, the mean incremental net monetary benefit was €1916 (SD=€783) in eMBCT and €2365 (SD=€796) in MBCT versus TAU. Exploration of costs demonstrated an equal pattern of eMBCT and MBCT being superior to TAU. Quality of life at 9-month follow-up remained improved in both interventions.
CONCLUSIONS


Results indicate that eMBCT and MBCT are cost-saving treatments whilst simultaneously improving quality of life for distressed cancer patients.",2020,"Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53).","['cancer patients', '245 self-referred heterogeneous cancer patients with psychological distress', 'distressed cancer patients']","['face Mindfulness-based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT', 'individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy', 'MBCT, eMBCT or TAU', 'eMBCT and MBCT']","['quality of life (utility scores', 'Quality of life', 'quality of life', 'EuroQol-5D-3L utility scores and Quality Adjusted Life Years (QALY', 'psychological distress', 'costs and quality of life', 'Healthcare costs and (informal) work-related productivity losses', 'mean incremental net monetary benefit', 'productivity losses and societal costs']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0378025,"Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53).","[{'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Compen', 'Affiliation': 'Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Nijmegen, The Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Adang', 'Affiliation': 'Department for Health Evidence, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Bisseling', 'Affiliation': 'Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Nijmegen, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van der Lee', 'Affiliation': 'Scientific Research Department, Helen Dowling Institute, Centre for Psycho-Oncology, Bilthoven, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Nijmegen Medical Centre for Mindfulness, Nijmegen, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5246']
222,31685496,"Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25° head-up position and supine: the InSize25 study protocol.","INTRODUCTION


Difficult airway management during tracheal intubation can lead to severe hypoxic sequelae. Routine intubation practice is to use a strict supine position, whereas a 25° head-up or reverse Trendelenburg position increases efficacy of preoxygenation, seems more comfortable for the anaesthetist and may also provide better intubation conditions in direct laryngoscopy. The 25° head-up position could be used for the whole population rather than only for obese patients, but there is no prospective randomised controlled trial with a robust design and large number of patients comparing strict supine against 25° intubation in operating room. The objective of the InSize25 study is to test the effect of these two patient positions on intubation conditions during laryngoscopy in scheduled surgery on non-obese patients.
METHODS AND ANALYSIS


InSize25 is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial. The InSize25 study will randomise 1000 adult patients scheduled for surgery under general anaesthesia requiring intubation with neuromuscular-blocking drugs, candidates for direct laryngoscopy. The primary outcome variable is the view obtained during the first laryngoscopy without any external manipulation assessed using percentage of glottic opening. Important secondary outcomes are: Cormack-Lehane classification, number of attempts at laryngoscopy and at tracheal intubation, use of ancillary equipment (eg, bougies, alternative laryngoscope blades, videolaryngoscope) and manoeuvres (eg, laryngeal manipulation), comfort score for the anaesthetist, episodes of postinduction hypotension or desaturation and mechanical complications of intubation.
ETHICS AND DISSEMINATION


The trial received appropriate approval from the 'CPP Sud-Est II' ethical review board. Informed consent is required. If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients. The final results will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov identifier (NCT03339141).",2019,"If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients.","['scheduled surgery on non-obese patients', '1000 adult patients scheduled for surgery under general anaesthesia requiring intubation with neuromuscular-blocking drugs, candidates for direct laryngoscopy']",['strict supine against 25° intubation in operating room'],"['view obtained during the first laryngoscopy without any external manipulation assessed using percentage of glottic opening', 'Cormack-Lehane classification, number of attempts at laryngoscopy and at tracheal intubation, use of ancillary equipment (eg, bougies, alternative laryngoscope blades, videolaryngoscope) and manoeuvres (eg, laryngeal manipulation), comfort score for the anaesthetist, episodes of postinduction hypotension or desaturation and mechanical complications of intubation']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0565527', 'cui_str': 'External manipulation (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0179390', 'cui_str': 'Bougie, device (physical object)'}, {'cui': 'C0563576', 'cui_str': 'Laryngoscope blade (physical object)'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0473161', 'cui_str': 'Anesthetist'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",1000.0,0.19736,"If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients.","[{'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Falempin', 'Affiliation': 'Department of Perioperative Medicine, University Hospital-Clermont-Ferrand, Clermont-Ferrand Cedex 1, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit of the Department of Clinical Research and Innovation (DRCI), University Hospital CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Binakdane', 'Affiliation': 'Department of Anaesthesia and Surgery Critical Care, Saint-Louis Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Smirdec', 'Affiliation': 'University Hospital-Clermont-Ferrand, Clermont-Ferrand Cedex 1, France msmirdec@chu-clermontferrand.fr.'}]",BMJ open,['10.1136/bmjopen-2019-029761']
223,31694845,Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study).,"INTRODUCTION


During cardiac surgery-associated bleeding, the early detection of coagulopathy is crucial. However, owing to time constraints or lack of suitable laboratory tests, transfusion of haemostatic products is often inappropriately triggered, either too late (exposing to prolonged bleeding and thus to avoidable administration of blood products) or blindly to the coagulation status (exposing to unnecessary haemostatic products administration in patients with no coagulopathy). Undue exposition to transfusion risks and additional healthcare costs may arise. With the perspective of secondary care-related costs, the IMOTEC study (Intérêt MédicO-économique de la Thrombo-Elastographie, dans le management transfusionnel des hémorragies péri-opératoires de chirurgies Cardiaques sous circulation extracorporelle) aims at assessing the cost-effectiveness of a point-of-care viscoelastic haemostatic assay (VHA: RoTem or TEG)-guided management of bleeding. Among several outcome measures, particular emphasis will be put on quality of life with a 1-year follow-up.
METHODS AND ANALYSIS


This is a multicentre, prospective, pragmatic study with stepped-wedge cluster randomised controlled design. Over a 36-month period (24 months of enrolment and 12 months of follow-up), 1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass will be included if a periprocedural significant bleeding occurs. The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life. Secondary outcomes are the cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality.
ETHICS AND DISSEMINATION


The study was registered at Clinicaltrials.gov and was approved by the Committee for the Protection of Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority. A publication of the results in a peer-reviewed journal is planned.
TRIAL REGISTRATION NUMBER


NCT02972684; Pre-results.",2019,"The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life.","['bleeding during cardiac surgery', '1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass', 'patients with no coagulopathy', 'Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority']",['point-of-care viscoelastic haemostatic assays'],"['cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality', 'quality of life with a 1-year follow-up', ""cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life""]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002045'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1293095', 'cui_str': 'Re-exploration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",1000.0,0.0885612,"The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life.","[{'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Rigal', 'Affiliation': 'Anesthésie et réanimation chirurgicale, Hôpital Guillaume et René Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France jeanchristophe.rigal@chu-nantes.fr.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Boissier', 'Affiliation': ""Laboratoire d'hématologie, Hôpital Guillaume et René Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lakhal', 'Affiliation': 'Anesthésie et réanimation chirurgicale, Hôpital Guillaume et René Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Valéry-Pierre', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': 'Direction de la recherche, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'URCECo Ile de France, Groupe hospitalier A.Chenevier, Henri Mondor, AP-HP, Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Rozec', 'Affiliation': 'Anesthésie et réanimation chirurgicale, Hôpital Guillaume et René Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}]",BMJ open,['10.1136/bmjopen-2019-029751']
224,31291683,"The effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene: A randomized controlled trial.","OBJECTIVE


To evaluate the effectiveness of the WhiteTeeth mobile app, a theory-based mobile health (mHealth) program for promoting oral hygiene in adolescent orthodontic patients.
METHODS


In this parallel randomized controlled trial, the data of 132 adolescents were collected during three orthodontic check-ups: at baseline (T0), at 6-week follow-up (T1) and at 12-week follow-up (T2). The intervention group was given access to the WhiteTeeth app in addition to usual care (n = 67). The control group received usual care only (n = 65). The oral hygiene outcomes were the presence and the amount of dental plaque (Al-Anezi and Harradine plaque index), and the total number of sites with gingival bleeding (Bleeding on Marginal Probing Index). Oral health behaviour and its psychosocial factors were measured through a digital questionnaire. We performed linear mixed-model analyses to determine the intervention effects.
RESULTS


At 6-week follow-up, the intervention led to a significant decrease in gingival bleeding (B = -3.74; 95% CI -6.84 to -0.65) and an increase in the use of fluoride mouth rinse (B = 1.93; 95% CI 0.36 to 3.50). At 12-week follow-up, dental plaque accumulation (B = -11.32; 95% CI -20.57 to -2.07) and the number of sites covered with plaque (B = -6.77; 95% CI -11.67 to -1.87) had been reduced significantly more in the intervention group than in the control group.
CONCLUSIONS


The results show that adolescents with fixed orthodontic appliances can be helped to improve their oral hygiene when usual care is combined with a mobile app that provides oral health education and automatic coaching. Netherlands Trial Registry Identifier: NTR6206: 20 February 2017.",2020,"At 6-week follow-up, the intervention led to a significant decrease in gingival bleeding (B = -3.74; 95% CI -6.84 to -0.65) and an increase in the use of fluoride mouth rinse (B = 1.93; 95% CI 0.36 to 3.50).","['132 adolescents', 'adolescent orthodontic patients', 'adolescents with fixed orthodontic appliances']","['WhiteTeeth app in addition to usual care', 'usual care only', 'WhiteTeeth mobile app, a theory-based mobile health (mHealth) program', 'mobile application (""WhiteTeeth']","['number of sites covered with plaque', 'amount of dental plaque (Al-Anezi and Harradine plaque index), and the total number of sites with gingival bleeding (Bleeding on Marginal Probing Index', 'dental plaque accumulation', 'oral hygiene', 'use of fluoride mouth rinse', 'gingival bleeding', 'Oral health behaviour and its psychosocial factors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0011389', 'cui_str': 'Dental Plaque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017565', 'cui_str': 'Gingival Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0029162'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",132.0,0.109076,"At 6-week follow-up, the intervention led to a significant decrease in gingival bleeding (B = -3.74; 95% CI -6.84 to -0.65) and an increase in the use of fluoride mouth rinse (B = 1.93; 95% CI 0.36 to 3.50).","[{'ForeName': 'Janneke F M', 'Initials': 'JFM', 'LastName': 'Scheerman', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Berno', 'Initials': 'B', 'LastName': 'van Meijel', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van Empelen', 'Affiliation': 'TNO Research Group, Leiden, The Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'TNO Research Group, Leiden, The Netherlands.'}, {'ForeName': 'Cor', 'Initials': 'C', 'LastName': 'van Loveren', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'VU Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Matheus C T', 'Initials': 'MCT', 'LastName': 'van den Braak', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gem J C', 'Initials': 'GJC', 'LastName': 'Kramer', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}]",International journal of dental hygiene,['10.1111/idh.12415']
225,31368583,Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT.,"OBJECTIVE


We describe the development of a lay-delivered behavioral intervention (""Do More, Feel Better"") for depressed senior center clients, and we present preliminary data from a pilot randomized controlled trial (RCT) on (a) the feasibility of training lay volunteers to fidelity and (b) the acceptability, impact, and safety of the intervention.
METHODS


We trained 11 volunteers at two aging service settings in ""Do More, Feel Better"" and randomized 18 depressed clients to receive the intervention or referral to mental health services.
RESULTS


Pilot data indicated that we can successfully train and certify 64% of older volunteers and that depressed clients receiving the intervention reported high levels of session attendance and satisfaction. While there were no significant differences in 12-week reduction in Hamilton Depression Rating Scale scores between groups, intervention clients showed an 8-point reduction in comparison with a 0-point reduction among referral clients.
CONCLUSIONS


""Do More, Feel Better"" has the potential of transferring evidence-based behavioral interventions to the hands of supervised lay volunteers and can address the insufficient workforce providing geriatric mental health services.",2019,"While there were no significant differences in 12-week reduction in Hamilton Depression Rating Scale scores between groups, intervention clients showed an 8-point reduction in comparison with a 0-point reduction among referral clients.
","['11 volunteers at two aging service settings in ""Do More, Feel Better"" and randomized 18 depressed clients to receive the', 'depressed senior center clients']","['behavioral intervention ', 'Lay-delivered behavioral activation', 'intervention or referral to mental health services']","['levels of session attendance and satisfaction', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}]","[{'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",11.0,0.0282289,"While there were no significant differences in 12-week reduction in Hamilton Depression Rating Scale scores between groups, intervention clients showed an 8-point reduction in comparison with a 0-point reduction among referral clients.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Psychiatry Department, Weill Cornell Medical College, White Plains, NY.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Dawson', 'Affiliation': 'Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Jaquelin', 'Initials': 'J', 'LastName': 'Berman', 'Affiliation': 'NYC Department for the Aging, New York City, NY.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Psychiatry Department, Geisel School of Medicine at Dartmouth, Lebanon, New Hamsphire.'}]",International journal of geriatric psychiatry,['10.1002/gps.5186']
226,31206358,Association of Elevated Plasma Interleukin-18 Level With Increased Mortality in a Clinical Trial of Statin Treatment for Acute Respiratory Distress Syndrome.,"OBJECTIVE


A high plasma level of inflammasome mediator interleukin-18 was associated with mortality in observational acute respiratory distress syndrome cohorts. Statin exposure increases both inflammasome activation and lung injury in mouse models. We tested whether randomization to statin therapy correlated with increased interleukin-18 in the ARDS Network Statins for Acutely Injured Lungs from Sepsis trial.
DESIGN


Retrospective analysis of randomized controlled clinical trial.
SETTING


Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis.
PATIENTS


Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population.
INTERVENTIONS


Random assignment of rosuvastatin or placebo for up to 28 days or 3 days after ICU discharge.
MEASUREMENTS AND MAIN RESULTS


We measured plasma interleukin-18 levels in all Statins for Acutely Injured Lungs from Sepsis patients with sample available at day 0 (baseline, n = 683) and day 3 (after randomization, n = 588). We tested the association among interleukin-18 level at baseline, rising interleukin-18, and the impact of statin therapy on 60-day mortality, adjusting for severity of illness. Baseline plasma interleukin-18 level greater than or equal to 800 pg/mL was highly associated with 60-day mortality, with a hazard of death of 2.3 (95% CI, 1.7-3.1). Rising plasma interleukin-18 was also associated with increased mortality. For each unit increase in log2 (interleukin-18) at day 3 compared with baseline, the hazard of death increased by 2.3 (95% CI, 1.5-3.5). Subjects randomized to statin were significantly more likely to experience a rise in plasma interleukin-18 levels. Subjects with acute kidney injury, shock, low baseline interleukin-18, and those not receiving systemic corticosteroids were more likely to experience rising interleukin-18. Randomization to statin therapy was associated with rising in interleukin-18 in all of those subsets, however.
CONCLUSIONS


Elevated baseline plasma interleukin-18 was associated with higher mortality in sepsis-induced acute respiratory distress syndrome. A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.",2019,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"['Acute Respiratory Distress Syndrome', 'Acutely Injured Lungs from Sepsis trial', 'Subjects with acute kidney injury', 'Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis', 'Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population']","['rosuvastatin or placebo', 'statin therapy']","['hazard of death', '60-day mortality', 'Baseline plasma interleukin-18 level', 'plasma interleukin-18 levels', 'mortality']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",683.0,0.63108,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trtchounian', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Kozikowski', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mogan', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Joo Heon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Nakahira', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M', 'Initials': 'AM', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Baron', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Critical care medicine,['10.1097/CCM.0000000000003816']
227,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS


Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
228,32271290,Comparison of Plyometric Training With Two Different Jumping Techniques on Achilles Tendon Properties and Jump Performances.,"Laurent, C, Baudry, S, and Duchateau, J. Comparison of plyometric training with two different jumping techniques on Achilles tendon properties and jump performances. J Strength Cond Res 34(6): 1503-1510, 2020-This study compared the influence of 10 weeks of plyometric training with 2 different jumping techniques on Achilles tendon properties and the height achieved in drop jumps (from 20, 40, and 60 cm) and countermovement jumps (CMJ). Subjects were allocated to 2 training groups (n = 11 in each group) and 1 control group (CON, n = 10). One training group kept the knees extended (KE) during ground contact, whereas the other training group flexed the knees to ∼80-90° (KF). Achilles tendon stiffness was assessed with ultrasonography, and jump performance was derived from force platform recording. Training increased jump height (p < 0.01) in both groups. The increase for the 20-cm drop jump was greater (p < 0.05) for the KE group (11.3%) thanfor the KF group (6.3%), with no statistical difference between groups for the 40- and 60-cm drop jumps. Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups. The increase in CMJ height was greater (p = 0.05) for the KF group (17.5%) than for the KE group (11.8%). Achilles tendon stiffness increased (32%; p < 0.001) for the KE group but not for the KF group (11%; p = 0.28). There was a positive association (p < 0.001) between the changes in tendon stiffness and jump height for 20-cm drop jump in both KE group (r = 0.49) and KF group (r = 0.62). None of these parameters changed in CON group. In conclusion, the extent of increase in jump height (20-cm drop jump and CMJ) and in Achilles tendon stiffness after training differed between the 2 jumping techniques.",2020,"Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups.",[],"['plyometric training with 2 different jumping techniques on Achilles tendon properties and the height achieved in drop jumps (from 20, 40, and 60 cm) and countermovement jumps (CMJ', 'J Strength Cond Res XX(X', 'One training group kept the knees extended (KE) during ground contact, whereas the other training group flexed the knees to ∼80-90° (KF', 'Plyometric Training With Two Different Jumping Techniques']","['Tendon Properties and Jump Performances', 'tendon stiffness and jump height', 'Achilles tendon stiffness', 'jump height', 'CMJ height', 'Achilles tendon properties and jump performances', 'Contact time']",[],"[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0186026,"Contact time during the 20-cm drop jump decreased (∼8%; p < 0.01) after training, with no difference between the training groups.","[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Help Center for Sports Performance (CAPS), Free University of Brussels (ULB), Brussels.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Baudry', 'Affiliation': 'Laboratory of Applied Biology and Neurophysiology, Free University of Brussels (ULB), Brussels.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duchateau', 'Affiliation': 'Help Center for Sports Performance (CAPS), Free University of Brussels (ULB), Brussels.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003604']
229,31748288,Sleeping sound with autism spectrum disorder (ASD): study protocol for an efficacy randomised controlled trial of a tailored brief behavioural sleep intervention for ASD.,"INTRODUCTION


Sleep problems are a characteristic feature of children with autism spectrum disorder (ASD) with 40% to 80% of children experiencing sleep difficulties. Sleep problems have been found to have a pervasive impact on a child's socio-emotional functioning, as well as on parents' psychological functioning. The  Sleeping Sound ASD  project aims to evaluate the efficacy of a brief behavioural sleep intervention in reducing ASD children's sleep problems in a fully powered randomised controlled trial (RCT). Intervention impact on child and family functioning is also assessed.
METHODS AND ANALYSIS


The RCT aims to recruit 234 children with a diagnosis of ASD, aged 5-13 years, who experience moderate to severe sleep problems. Participants are recruited from paediatrician clinics in Victoria, Australia, and via social media. Families interested in the study are screened for eligibility via phone, and then asked to complete a baseline survey online, assessing child sleep problems, and child and family functioning. Participants are then randomised to the intervention group or treatment as usual comparator group. Families in the intervention group attend two face-to-face sessions and a follow-up phone call with a trained clinician, where families are provided with individually tailored behavioural sleep strategies to help manage the child's sleep problems. Teacher reports of sleep, behavioural and social functioning are collected, and cognitive ability assessed to provide measures blind to treatment group. The primary outcome is children's sleep problems as measured by the Children's Sleep Habits Questionnaire at 3 months post-randomisation. Secondary outcomes include parent and child quality of life; child social, emotional, behavioural and cognitive functioning; and parenting stress and parent mental health. Cost-effectiveness of the intervention is also evaluated.
ETHICS AND DISSEMINATION


Findings from this study will be published in peer-reviewed journals and disseminated at national and international conferences, local networks and online.
TRIAL REGISTRATION NUMBER


ISRCTN14077107 (ISRCTN registry dated on 3 March 2017).",2019,The  Sleeping Sound ASD  project aims to evaluate the efficacy of a brief behavioural sleep intervention in reducing ASD children's sleep problems in a fully powered randomised controlled trial (RCT).,"[""ASD children's sleep problems"", '234 children with a diagnosis of ASD, aged 5-13 years, who experience moderate to severe sleep problems', 'children with autism spectrum disorder (ASD) with 40% to 80% of children experiencing sleep difficulties', 'Sleeping sound with autism spectrum disorder (ASD', 'Participants are recruited from paediatrician clinics in Victoria, Australia, and via social media']",['behavioural sleep intervention'],"[""children's sleep problems as measured by the Children's Sleep Habits Questionnaire"", 'parent and child quality of life; child social, emotional, behavioural and cognitive functioning; and parenting stress and parent mental health', 'Cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0034380'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",234.0,0.123703,The  Sleeping Sound ASD  project aims to evaluate the efficacy of a brief behavioural sleep intervention in reducing ASD children's sleep problems in a fully powered randomised controlled trial (RCT).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia nicole.papadopoulos@deakin.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Susannah T', 'Initials': 'ST', 'LastName': 'Bellows', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Marks', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Howlin', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rinehart', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-029767']
230,31699723,Phase II randomised control feasibility trial of a nutrition and physical activity intervention after radical prostatectomy for prostate cancer.,"OBJECTIVE


Dietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate cancer.
DESIGN


Patients were recruited into a presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 factorial randomised controlled trial (RCT).
SETTING


A single National Health Service trust in the South West of England, UK.
PARTICIPANTS


Those with localised prostate cancer and listed for radical prostatectomy were invited to participate.
RANDOMISATION


Random allocation was performed by the Bristol Randomised Trial Collaboration via an online system.
INTERVENTIONS


Men were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6 months.
BLINDING


Only the trial statistician was blind to allocations.
PRIMARY OUTCOME MEASURES


Primary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%.
RESULTS


108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 months (75/81; 92.6%). Three 'possibly related' adverse events were indigestion, abdominal bloating and knee pain.
CONCLUSIONS


Interventions were deemed feasible, with high randomisation rates and generally good adherence. A definitive RCT is proposed.
TRIAL REGISTRATION NUMBER


ISRCTN 99048944.",2019,"Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%).","['Patients were recruited into a presurgical observational cohort; following', 'radical prostatectomy for prostate cancer', 'A single National Health Service trust in the South West of England, UK', 'Those with localised prostate cancer and listed for radical prostatectomy were invited to participate', '108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial']","['radical prostatectomy', 'lycopene', 'lifestyle interventions', 'nutrition and physical activity intervention', 'modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6\u2009months']","['indigestion, abdominal bloating and knee pain', 'adherence rate', 'feasibility: randomisation rates and intervention adherence at 6\u2009months']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",108.0,0.183582,"Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%).","[{'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Hackshaw-McGeagh', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre (Nutrition Theme), University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Penfold', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre (Surgical Innovation Theme), Musculoskeletal Research Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Shingler', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre (Nutrition Theme), University of Bristol, Bristol, UK.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Robles', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Perks', 'Affiliation': 'Bristol Medical School: Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jeff M P', 'Initials': 'JMP', 'LastName': 'Holly', 'Affiliation': 'Bristol Medical School: Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Koupparis', 'Affiliation': 'Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Bristol Haematology and Oncology Centre, University Hospitals Bristol, Bristol, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Persad', 'Affiliation': 'Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Shiridzinomwa', 'Affiliation': 'Clinical Research Centre, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Clinical Research Centre, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Kalina M', 'Initials': 'KM', 'LastName': 'Biernacka', 'Affiliation': 'Bristol Medical School: Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Frankow', 'Affiliation': 'Bristol Medical School: Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': 'Institute for Global Food Security, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilchrist', 'Affiliation': 'Institute for Global Food Security, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK athene.lane@bristol.ac.uk.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029480']
231,31780587,Efficacy of electroacupuncture for the treatment of constipation in Parkinson's disease: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Constipation is one of the most common non-motor symptoms in Parkinson's disease (PD). Acupuncture can have a positive on chronic functional constipation and PD, but its efficacy for the treatment of constipation in PD has not yet been confirmed by high-quality clinical trials. Therefore, this study aims to evaluate the efficacy and safety of electroacupuncture (EA) in the treatment of constipation in PD.
METHODS AND ANALYSIS


This study is a multicentre randomised controlled trial. A total of 124 qualified patients with PD and constipation will be randomly divided into the intervention group (62 participants will receive 12 weeks of EA +usual care) or the waitlist control group (62 participants will receive 12 weeks of usual care). EA will be performed three times per week from weeks 1-8, two times per week during weeks 9 and 10, and once a week during weeks 11 and 12. The primary outcome is the change in mean weekly spontaneous bowel movements from baseline to weeks 8 and 9. The secondary outcomes are the changes from baseline in mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining. Other secondary outcomes include the weekly doses of defecation drugs, Visual Analogue Scale for subjective improvements in stool symptoms, Unified Parkinson's Disease Rating Scale, and the time and number of steps required to walk 20 m. Outcomes will be assessed at baseline, week 4, 8, 12 (intervention period); as well as at week 16, 24 (follow-up period).
ETHICS AND DISSEMINATION


Ethical approval has been obtained from four local ethics committees. The results of the study will be published in peer-reviewed journals and will be disseminated through national and international conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900021053.",2019,"The secondary outcomes are the changes from baseline in mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining.","['124 qualified patients with PD and constipation', 'constipation in PD', ""constipation in Parkinson's disease"", ""Parkinson's disease (PD""]","['electroacupuncture', 'electroacupuncture (EA', 'Acupuncture', 'EA +usual\u2009care) or the waitlist control group']","['efficacy and safety', 'mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining', ""weekly doses of defecation drugs, Visual Analogue Scale for subjective improvements in stool symptoms, Unified Parkinson's Disease Rating Scale, and the time and number of steps required to walk 20 m. Outcomes"", 'change in mean weekly spontaneous bowel movements']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",124.0,0.169353,"The secondary outcomes are the changes from baseline in mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining.","[{'ForeName': 'Kunshan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhaoqin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yiyi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Shanghai Pudong New Area Hospital of Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhongqiu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Canxing', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Luyi', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Departement of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China wuhuangan@126.com xu_teacher2006@126.com.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China wuhuangan@126.com xu_teacher2006@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-029841']
232,30326162,Interventions for preventing and treating cardiac complications in Duchenne and Becker muscular dystrophy and X-linked dilated cardiomyopathy.,"BACKGROUND


The dystrophinopathies include Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and X-linked dilated cardiomyopathy (XLDCM). In recent years, co-ordinated multidisciplinary management for these diseases has improved the quality of care, with early corticosteroid use prolonging independent ambulation, and the routine use of non-invasive ventilation signficantly increasing survival. The next target to improve outcomes is optimising treatments to delay the onset or slow the progression of cardiac involvement and so prolong survival further.
OBJECTIVES


To assess the effects of interventions for preventing or treating cardiac involvement in DMD, BMD, and XLDCM, using measures of change in cardiac function over six months.
SEARCH METHODS


On 16 October 2017 we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE and Embase, and on 12 December 2017, we searched two clinical trials registries. We also searched conference proceedings and bibliographies.
SELECTION CRITERIA


We considered only randomised controlled trials (RCTs), quasi-RCTs and randomised cross-over trials for inclusion. In the Discussion, we reviewed open studies, longitudinal observational studies and individual case reports but only discussed studies that adequately described the diagnosis, intervention, pretreatment, and post-treatment states and in which follow-up lasted for at least six months.
DATA COLLECTION AND ANALYSIS


Two authors independently reviewed the titles and abstracts identified from the search and performed data extraction. All three authors assessed risk of bias independently, compared results, and decided which trials met the inclusion criteria. They assessed the certainty of evidence using GRADE criteria.
MAIN RESULTS


We included five studies (N = 205) in the review; four studies included participants with DMD only, and one study included participants with DMD or BMD. All studied different interventions, and meta-analysis was not possible. We found no studies for XLDCM. None of the trials reported cardiac function as improved or stable cardiac versus deteriorated.The randomised first part of a two-part study of perindopril (N = 28) versus placebo (N = 27) in boys with DMD with normal heart function at baseline showed no difference in the number of participants with a left ventricular ejection fraction (LVEF%) of less than 45% after three years of therapy (n = 1 in each group; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.07 to 15.77). This result is uncertain because of study limitations, indirectness and imprecision. In a non-randomised follow-up study, after 10 years, more participants who had received placebo from the beginning had reduced LVEF% (less than 45%). Adverse event rates were similar between the placebo and treatment groups (low-certainty evidence).A study comparing treatment with lisinopril versus losartan in 23 boys newly diagnosed with Duchenne cardiomyopathy showed that after 12 months, both were equally effective in preserving or improving LVEF% (lisinopril 54.6% (standard deviation (SD) 5.19), losartan 55.2% (SD 7.19); mean difference (MD) -0.60% CI -6.67 to 5.47: N = 16). The certainty of evidence was very low because of very serious imprecision and study limitations (risk of bias). Two participants in the losartan group were withdrawn due to adverse events: one participant developed an allergic reaction, and a second exceeded the safety standard with a fall in ejection fraction greater than 10%. Authors reported no other adverse events related to the medication (N = 22; very low-certainty evidence).A study comparing idebenone versus placebo in 21 boys with DMD showed little or no difference in mean change in cardiac function between the two groups from baseline to 12 months; for fractional shortening the mean change was 1.4% (SD 4.1) in the idebenone group and 1.6% (SD 2.6) in the placebo group (MD -0.20%, 95% CI -3.07 to 2.67, N = 21), and for ejection fraction the mean change was -1.9% (SD 9.8) in the idebenone group and 0.4% (SD 5.5) in the placebo group (MD -2.30%, 95% CI -9.18 to 4.58, N = 21). The certainty of evidence was very low because of study limitations and very serious imprecision. Reported adverse events were similar between the treatment and placebo groups (low-certainty evidence).A multicentre controlled study added eplerenone or placebo to 42 patients with DMD with early cardiomyopathy but preserved left ventricular function already established on ACEI or ARB therapy. Results showed that eplerenone slowed the rate of decline of magnetic resonance (MR)-assessed left ventricular circumferential strain at 12 months (eplerenone group median 1.0%, interquartile range (IQR) 0.3 to -2.2; placebo group median 2.2%, IQR 1.3 to -3.1%; P = 0.020). The median decline in LVEF over the same period was also less in the eplerenone group (-1.8%, IQR -2.9 to 6.0) than in the placebo group (-3.7%, IQR -10.8 to 1.0; P = 0.032). We downgraded the certainty of evidence to very low for study limitations and serious imprecision. Serious adverse events were reported in two patients given placebo but none in the treatment group (very low-certainty evidence).A randomised placebo-controlled study of subcutaneous growth hormone in 16 participants with DMD or BMD showed an increase in left ventricular mass after three months' treatment but no significant improvement in cardiac function. The evidence was of very low certainty due to imprecision, indirectness, and study limitations. There were no clinically significant adverse events (very low-certainty evidence).Some studies were at risk of bias, and all were small. Therefore, although there is some evidence from non-randomised data to support the prophylactic use of perindopril for cardioprotection ahead of detectable cardiomyopathy, and for lisinopril or losartan plus eplerenone once cardiomyopathy is detectable, this must be considered of very low certainty. Findings from non-randomised studies, some of which have been long term, have led to the use of these drugs in daily clinical practice.
AUTHORS' CONCLUSIONS


Based on the available evidence from RCTs, early treatment with ACE inhibitors or ARBs may be comparably beneficial for people with a dystrophinopathy; however, the certainty of evidence is very low. Very low-certainty evidence indicates that adding eplerenone might give additional benefit when early cardiomyopathy is detected. No clinically meaningful effect was seen for growth hormone or idebenone, although the certainty of the evidence is also very low.",2018,Serious adverse events were reported in two patients given placebo but none in the treatment group (very low-certainty evidence).A randomised placebo-controlled study of subcutaneous growth hormone in 16 participants with DMD or BMD showed an increase in left ventricular mass after three months' treatment but no significant improvement in cardiac function.,"['five studies (N = 205) in the review; four studies included participants with DMD only, and one study included participants with DMD or BMD', '16 participants with DMD or BMD', '16 October 2017 we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE and Embase, and on 12 December 2017', '42 patients with DMD with early cardiomyopathy but preserved left ventricular function already established on ACEI or ARB therapy']","['lisinopril versus losartan', 'perindopril', 'placebo', 'eplerenone', 'losartan', 'eplerenone or placebo']","['left ventricular ejection fraction (LVEF', 'median decline in LVEF', 'effective in preserving or improving LVEF', 'adverse events', 'left ventricular mass', 'Adverse event rates', 'rate of decline of magnetic resonance (MR)-assessed left ventricular circumferential strain', 'Serious adverse events', 'cardiac function']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0025141', 'cui_str': 'MEDLINE'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0080310', 'cui_str': 'Left Ventricular Function'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",16.0,0.350498,Serious adverse events were reported in two patients given placebo but none in the treatment group (very low-certainty evidence).A randomised placebo-controlled study of subcutaneous growth hormone in 16 participants with DMD or BMD showed an increase in left ventricular mass after three months' treatment but no significant improvement in cardiac function.,"[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bourke', 'Affiliation': 'Department of Cardiology, Freeman Hospital, Freeman Road, Newcastle Upon Tyne, UK, NE7 DN.'}, {'ForeName': 'Teofila', 'Initials': 'T', 'LastName': 'Bueser', 'Affiliation': ''}, {'ForeName': 'Rosaline', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009068.pub3']
233,31471309,Angiogenic Factor and Cytokine Analysis among Patients Treated with Adjuvant VEGFR TKIs in Resected Renal Cell Carcinoma.,"PURPOSE


The use of VEGFR TKIs for the adjuvant treatment of renal cell carcinoma (RCC) remains controversial. We investigated the effects of adjuvant VEGFR TKIs on circulating cytokines in the ECOG-ACRIN 2805 (ASSURE) trial.
EXPERIMENTAL DESIGN


Patients with resected high-risk RCC were randomized to sunitinib, sorafenib, or placebo. Plasma from 413 patients was analyzed from post-nephrectomy baseline, 4 weeks, and 6 weeks after treatment initiation. Mixed effects and Cox proportional hazards models were used to test for changes in circulating cytokines and associations between disease-free survival (DFS) and cytokine levels.
RESULTS


VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously). sFLT-1 decreased after 4 weeks on sunitinib and 6 weeks on sorafenib ( P  < 0.0001). sVEGFR-2 decreased after both 4 and 6 weeks of treatment on sunitinib or sorafenib ( P  < 0.0001). Patients receiving placebo had no significant changes in cytokine levels. CXCL10 was elevated at 4 and 6 weeks on sunitinib and sorafenib but not on placebo. Higher baseline CXCL10 was associated with worse DFS (HR 1.41 per log increase in CXCL10, Bonferroni-adjusted  P  = 0.003). This remained significant after adjustment for T-stage, Fuhrman grade, and ECOG performance status.
CONCLUSIONS


Among patients treated with adjuvant VEGFR TKIs for RCC, drug-host interactions mediate changes in circulating cytokines. Elevated baseline CXCL10 was associated with worse DFS. Studies to understand functional consequences of these changes are under way.",2019,Results:  VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously).,"['renal cell carcinoma', 'Patients Treated with Adjuvant VEGFR TKIs in Resected Renal Cell Carcinoma', 'Patients with resected high-risk RCC']","['sunitinib, sorafenib, or placebo', 'placebo', 'sunitinib or sorafenib', 'sunitinib and sorafenib', 'adjuvant VEGFR TKIs', 'sorafenib', 'VEGFR TKIs']","['cytokine levels', 'CXCL10', 'circulating cytokines and associations between disease-free survival (DFS) and cytokine levels', 'sFLT-1', 'VEGF and PlGF', 'Angiogenic Factor and Cytokine Analysis', 'sVEGFR-2']","[{'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1313526', 'cui_str': 'S2FLT'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",413.0,0.137724,Results:  VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously).,"[{'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Manola', 'Affiliation': 'Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tamasauskas', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, District of Columbia.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Janice P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': 'The Cancer Research Foundation, Bronx, New York.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Rupal S', 'Initials': 'RS', 'LastName': 'Bhatt', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts. rbhatt@bidmc.harvard.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0818']
234,31722937,Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.,"INTRODUCTION


The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.
METHODS AND ANALYSIS


Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered.
ETHICS AND DISSEMINATION


The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT03821649).",2019,"A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.
","['Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings']","['naloxone education and resuscitation', 'intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme']","['recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4505067', 'cui_str': 'Addiction Medicine'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0042950', 'cui_str': 'Will'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}]",28.0,0.125948,"A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Orkin', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada aaron.orkin@mail.utoronto.ca.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': ""Allan Waters Family Simulation Centre, St. Michael's Hospital, Unity Health, Toronto, Ontario, Canada.""}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Handford', 'Affiliation': ""Department of Family and Community Medicine, St. Michael's Hospital, Unity Health, Toronto, Ontario, Canada.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Toronto Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Klaiman', 'Affiliation': ""Department of Emergency Medicine, St. Michael's Hospital, Unity Health, Toronto, Ontario, Canada.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Leece', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Parsons', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Shahin', 'Affiliation': 'Toronto Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Strike', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thorpe', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sellen', 'Affiliation': 'Design for Health, OCAD University, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Milos', 'Affiliation': ""SOONER Project Community Advisory Committee, St. Michael's Hospital, Unity Health, Toronto, Ontario, Canada.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Toronto Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Charles', 'Affiliation': ""Allan Waters Family Simulation Centre, St. Michael's Hospital, Unity Health, Toronto, Ontario, Canada.""}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Sniderman', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029436']
235,31378952,Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).,"AIMS


While several generic preparations of levodopa/carbidopa and levodopa/benserazide (LBD) are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug.
METHODS


An experimental, 2-centre, randomized, double-blind, 2-sequence, noninferiority cross-over study was designed to evaluate both the PK equivalence and clinical equivalence of multiple doses of the generic preparation of LDB, Teva Italia, compared to the originator (Madopar). Forty-three out-patients with a diagnosis of idiopathic Parkinson's disease on LDB, were recruited and randomly assigned to 1 of 2 study sequences: generic-originator or originator-generic. Clinical evaluations were performed at the end of each study period. A PK study with an LDB fixed dose (100 + 25 mg) was performed in a subpopulation of 14 subjects.
RESULTS


Clinical data showed a reduction of 0.49 and 1.54 in the mean UPDRS III scores for the LDB and the originator, respectively. The 95% CIs [-2.21: 0.11] of the mean difference original vs LDB are smaller than the clinically significant difference of 3 UPDRS III points, supporting the conclusion that the treatment with LDB is not inferior to the originator. No statistically significant differences were found with respect to area under the curve to last dose, half-life, maximum concentration, time to maximum concentration and last observed concentration.
CONCLUSION


These findings prove the therapeutic clinical equivalence as well the PK equivalence of the generic LDB and the originator (Madopar).",2019,"No statistically significant differences were found with respect to AUC 0-t  ,t ½  , C max,  T max  , and C last  .
","['sub-population of 14 subjects', ""Forty-three out-patients with a diagnosis of idiopathic Parkinson's disease (PD) on LDB""]","['Levodopa/carbidopa and Levodopa/benserazide', 'generic-originator or originator-generic', 'Levodopa benserazide (LDB), Teva Italia, compared to the ""originator"" (Madopar®']","['mean UPDRS III scores', 'AUC 0-t  ,t ½  , C max,  T max  , and C last  ']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0005014', 'cui_str': 'Benserazide'}, {'cui': 'C0065502', 'cui_str': 'modopar'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",43.0,0.0506038,"No statistically significant differences were found with respect to AUC 0-t  ,t ½  , C max,  T max  , and C last  .
","[{'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Torti', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Jhessica', 'Initials': 'J', 'LastName': 'Alessandroni', 'Affiliation': 'BioBIM - Multidisciplinary Interistitutional BioBank San Raffaele Pisana -Research Center, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bravi', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Casali', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Grassini', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fossati', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Ialongo', 'Affiliation': 'Department of Physiology and Pharmacology ""Vittorio Erspamer"", Sapienza University of Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Onofrj', 'Affiliation': 'Neurology Department, Università ""G. D\'Annunzio"" di Chieti, Italy.'}, {'ForeName': 'Fabiana Giada', 'Initials': 'FG', 'LastName': 'Radicati', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vacca', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bonassi', 'Affiliation': 'IRCCS San Raffaele Pisana, Clinical and Molecular Epidemiology Unit, Italy (Statistical Analysis) And Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': ""Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.""}]",British journal of clinical pharmacology,['10.1111/bcp.14086']
236,31719071,Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial.,"OBJECTIVES


To determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.
DESIGN


Randomised controlled feasibility trial.
SETTING


Two vascular Centres in South Wales, UK.
PARTICIPANTS


50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.
INTERVENTIONS


The treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.
RESULTS


Seventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.
CONCLUSIONS


Recruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.
TRIAL REGISTRATION NUMBER


ISRCTN: 85 710 690. EudraCT: 2016-003544-37.",2019,Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation.,"['50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease', 'Two vascular Centres in South Wales, UK', 'Seventy-six of 103 screened patients were deemed eligible over a 10\u2009month period', 'after major lower limb amputation trial (PLACEMENT']","['local anaesthetic nor PNC', 'usual perioperative anaesthesia and postoperative analgesia', 'Perineural local anaesthetic catheter', 'levobupivacaine hydrochloride', 'EudraCT', 'perineural catheter (PNC']","['pain scores', 'proportion of recruited patients reaching 2 and 6\u2009month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain', '4-point verbal rating scale', 'Attrition rates']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb (procedure)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0085096', 'cui_str': 'Peripheral Angiopathies'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0873119', 'cui_str': 'Levobupivacaine hydrochloride'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}]",49.0,0.285959,Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bosanquet', 'Affiliation': 'Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK davebosanquet@hotmail.com.'}, {'ForeName': 'Graeme K', 'Initials': 'GK', 'LastName': 'Ambler', 'Affiliation': 'Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Cherry-Ann', 'Initials': 'CA', 'LastName': 'Waldron', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kelson', 'Affiliation': 'Department of Mathematics, College of Engineering, Mathematics and Physical Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Milosevic', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, College of Human Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Saxena', 'Affiliation': 'Department of Anaesthetics, Royal Glamorgan Hospital, Cwm Taf University Health Board, Abercynon, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Twine', 'Affiliation': 'Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029233']
237,31719072,"Study protocol for a randomised, double-blind, placebo-controlled study evaluating the Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease: the EMERALD trial.","INTRODUCTION


Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder with no known cure and with an average life expectancy of 3-5 years post diagnosis. The use of complementary medicine such as medicinal cannabis in search for a potential treatment or cure is common in ALS. Preclinical studies have demonstrated the efficacy of cannabinoids in extending the survival and slowing of disease progression in animal models with ALS. There are anecdotal reports of cannabis slowing disease progression in persons with ALS (pALS) and that cannabis alleviated the symptoms of spasticity and pain. However, a clinical trial in pALS with these objectives has not been conducted.
METHODS AND ANALYSIS


The Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease trial is a randomised, double-blind, placebo-controlled cannabis trial in pALS conducted at the Gold Coast University Hospital, Australia. The investigational product will be a cannabis-based medicine extract (CBME) supplied by CannTrust Inc., Canada, with a high-cannabidiol-low-tetrahydrocannabinol concentration. A total of 30 pALS with probable or definite ALS diagnosis based on the El Escorial criteria, with a symptom duration of <2 years, age between 25 and 75years and with at least 70% forced vital capacity (FVC) will be treated for 6 months. The primary objective of the study is to evaluate the efficacy of CBME compared with placebo in slowing the disease progression measured by differences in mean ALS Functional Rating Scale-Revised and FVC score between the groups at the end of treatment. The secondary objectives are to evaluate the safety and tolerability of CBME by summarising adverse events, the effects of CBME on spasticity, pain, weight loss and quality of life assessed by the differences in mean Numeric Rating Scale for spasticity and Numeric Rating Scale for pain, percentage of total weight loss and ALS specific quality of life-Revised questionnaire.
ETHICS AND DISSEMINATION


The study has been approved by the local Institutional Review Board. The results of this study will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03690791.",2019,"The Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease trial is a randomised, double-blind, placebo-controlled cannabis trial in pALS conducted at the Gold Coast University Hospital, Australia.","['Amyotrophic Lateral sclerosis or motor neurone Disease', 'persons with ALS (pALS', 'A total of 30 pALS with probable or definite ALS diagnosis based on the El Escorial criteria, with a symptom duration of <2 years, age between 25 and 75years and with at least 70% forced vital capacity (FVC']","['placebo', 'cannabis-based Medicine Extract', 'CBME']","['mean ALS Functional Rating Scale-Revised and FVC score', 'mean Numeric Rating Scale for spasticity and Numeric Rating Scale for pain, percentage of total weight loss and ALS specific quality of life-Revised questionnaire', 'spasticity, pain, weight loss and quality of life', 'safety and tolerability']","[{'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0085084', 'cui_str': 'Motor System Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.168876,"The Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease trial is a randomised, double-blind, placebo-controlled cannabis trial in pALS conducted at the Gold Coast University Hospital, Australia.","[{'ForeName': 'Berzenn', 'Initials': 'B', 'LastName': 'Urbi', 'Affiliation': 'Neurology, Gold Coast Hospital and Health Service, Southport, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Broadley', 'Affiliation': 'Neurology, Gold Coast Hospital and Health Service, Southport, Queensland, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bedlack', 'Affiliation': 'School of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'International Cannabis and Cannabinoids Institute, Prague, Czech Republic.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'Neurology, Gold Coast Hospital and Health Service, Southport, Queensland, Australia Arman.Sabet@health.qld.gov.au.'}]",BMJ open,['10.1136/bmjopen-2019-029449']
238,31332820,"Efficacy, safety and pharmacokinetics of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control.","AIMS


The objectives were to investigate the pharmacokinetics, pharmacodynamics and safety of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control, and then recommend the dosage regimen for Phase 2b/3 studies.
METHODS


Three clinical studies were performed. First, 16 healthy subjects received infusion of ilaprazole 30 mg or esomeprazole 80 mg. Second, 12 healthy subjects received ilaprazole 20 mg followed by 10 mg once daily for 2 days. Finally, 20 patients with duodenal ulcers received ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole 40 mg twice daily for 3 days. Serial blood samples were collected and intragastric pH was recorded.
RESULTS


The mean percentages time of intragastric pH >6 was 63.6 and 51.7% for healthy subjects after receiving ilaprazole 30 mg and esomeprazole 80 mg. Linear pharmacokinetics was observed when the dose was increased to 30 mg but the effect was saturated. Ilaprazole 20 mg followed by 10 mg for 2 days provided higher plasma exposure in healthy subjects than patients, but the effect was comparable. After multiple administrations, ilaprazole provided similar effect to esomeprazole. Ilaprazole infusion was safe and well tolerated without serious adverse events.
CONCLUSIONS


Ilaprazole provided comparable effect of pH control to esomeprazole, with lower dose and fewer times of administration. There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibition. A loading dose of ilaprazole 20 mg followed by 10 mg once daily for 2 days was recommended for Phase 2b/3 studies.",2019,There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibiton.,"['healthy subjects and patients with esomeprazole as positive control', 'healthy subjects and patients with', '16 healthy subjects', 'healthy subjects', '20 patients with duodenal ulcers', '12 healthy subjects']","['Ilaprazole infusion', 'ilaprazole 30 mg or esomeprazole', 'ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole', 'Ilaprazole', 'ilaprazole infusion', 'ilaprazole', 'esomeprazole']","['Linear pharmacokinetics', 'Efficacy, safety and pharmacokinetics', 'plasma exposure', 'ilaprazole', 'pharmacokinetics, pharmacodynamics and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}]","[{'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",16.0,0.0331802,There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibiton.,"[{'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ou', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xianghong', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Haitang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Livzon Pharmaceutical Group Inc, Zhuhai, Guangdong, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14076']
239,31772085,Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial.,"OBJECTIVE


This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.
DESIGN


A prospective, randomized, controlled design.
SETTING


Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand.
PARTICIPANTS


210 parents of children with thalassemia (age=35.6 ± 13.1 years).
INTERVENTIONS


The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.
PRIMARY AND SECONDARY OUTCOME MEASURES


Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.
RESULTS


Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
CONCLUSIONS


The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.",2019,"The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
","['210 parents of children with thalassemia (age=35.6 ± 13.1 years', 'Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand']","['SIDCER ICF (n=105) or the conventional ICF', 'SIDCER ICF', 'conventional ICF']","['proportion of parents who obtained the understanding score', 'total score']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0444966', 'cui_str': 'ICF'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",210.0,0.0697074,"The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
","[{'ForeName': 'Nut', 'Initials': 'N', 'LastName': 'Koonrungsesomboon', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chanchai', 'Initials': 'C', 'LastName': 'Traivaree', 'Affiliation': 'Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Charnunnut', 'Initials': 'C', 'LastName': 'Tiyapsane', 'Affiliation': 'Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Juntra', 'Initials': 'J', 'LastName': 'Karbwang', 'Affiliation': 'Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan Jkarbwang@yahoo.com.'}]",BMJ open,['10.1136/bmjopen-2019-029530']
240,31309627,In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.,"Ultraviolet light enhances the generation of reactive oxygen species that are responsible for skin photoageing. The aim of this randomized, vehicle- and active-controlled double-blind, intra-individual monocentric study was to evaluate in situ the antioxidant activity of a dermo-cosmetic product in photoaged skin. Twenty healthy volunteers had defined skin areas randomized to receive a topical product containing 3 antioxidants (pre-tocopheryl ®  , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream. The products were applied daily for 30-day period. The skin areas were exposed to a controlled dose of UVA rays, and the skin oxidative status was evaluated 4 and 24 hours post-UVA exposure at D0 (basal value) and after 15 and 30 days of product application. Skin layers were collected by stripping, and antioxidant capacity was measured using the ferric reducing ability of a plasma assay. Lipid peroxidation (LPO) was assessed using the malonyldialdehyde test. The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO. The skin LPO level significantly decreased 4 and 24 hours after UVA exposure at 15 and 30 days. These findings were comparable to positive control treated sites and were significantly different from the vehicle and untreated sites. This minimally invasive methodology enabled a quantitative evaluation of potent antioxidant activity in situ in the stratum corneum reflecting real-life skin conditions and confirming the benefits of the topical application of a product containing 3 antioxidants in the prevention of UVA-induced oxidative damage.",2019,The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO.,"['Twenty healthy volunteers had defined skin areas', 'photoaged skin']","['topical product containing 3 antioxidants (pre-tocopheryl ®  , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream']","['Lipid peroxidation (LPO', 'skin oxidative status', 'Skin layers', 'skin LPO level', 'basal level of the skin LPO', 'skin antioxidant capacity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C3205659', 'cui_str': 'Topical Product'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1669538', 'cui_str': 'pretocopheryl'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0017984', 'cui_str': 'Glycylglycine'}, {'cui': 'C0002482', 'cui_str': 'Amides'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1282402', 'cui_str': 'Skin layer'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",20.0,0.0699519,The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO.,"[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Ribet', 'Affiliation': 'Clinical Skin Research Center, Pierre Fabre Dermo-Cosmetics, Toulouse, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Nobile', 'Affiliation': 'Complife Italia, San Martino Siccomario (PV), Italy.'}, {'ForeName': 'Ana Beatris', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Clinical Skin Research Center, Pierre Fabre Dermo-Cosmetics, Toulouse, France.'}]",Experimental dermatology,['10.1111/exd.14005']
241,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
242,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
243,32294530,"Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study.","BACKGROUND


Targeting the programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) axis has demonstrated clinical benefit in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Combining immunotherapies targeting PD-L1 and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) has shown evidence of additive activity in several tumor types. This phase III study evaluated the efficacy of durvalumab (an anti-PD-L1 monoclonal antibody) or durvalumab plus tremelimumab (an anti-CTLA-4 monoclonal antibody) versus standard of care (SoC) in R/M HNSCC patients.
PATIENTS AND METHODS


Patients were randomly assigned to receive 1 : 1 : 1 durvalumab (10 mg/kg every 2 weeks [q2w]), durvalumab plus tremelimumab (durvalumab 20 mg/kg q4w plus tremelimumab 1 mg/kg q4w × 4, then durvalumab 10 mg/kg q2w), or SoC (cetuximab, a taxane, methotrexate, or a fluoropyrimidine). The primary end points were overall survival (OS) for durvalumab versus SoC, and OS for durvalumab plus tremelimumab versus SoC. Secondary end points included progression-free survival (PFS), objective response rate, and duration of response.
RESULTS


Patients were randomly assigned to receive durvalumab (n = 240), durvalumab plus tremelimumab (n = 247), or SoC (n = 249). No statistically significant improvements in OS were observed for durvalumab versus SoC [hazard ratio (HR): 0.88; 95% confidence interval (CI): 0.72-1.08; P = 0.20] or durvalumab plus tremelimumab versus SoC (HR: 1.04; 95% CI: 0.85-1.26; P = 0.76). The 12-month survival rates (95% CI) were 37.0% (30.9-43.1), 30.4% (24.7-36.3), and 30.5% (24.7-36.4) for durvalumab, durvalumab plus tremelimumab, and SoC, respectively. Treatment-related adverse events (trAEs) were consistent with previous reports. The most common trAEs (any grade) were hypothyroidism for durvalumab and durvalumab plus tremelimumab (11.4% and 12.2%, respectively), and anemia (17.5%) for SoC. Grade ≥3 trAE rates were 10.1%, 16.3%, and 24.2% for durvalumab, durvalumab plus tremelimumab, and SoC, respectively.
CONCLUSION


There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC. However, higher survival rates at 12 to 24 months and response rates demonstrate clinical activity for durvalumab.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02369874.",2020,There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC.,"['patients with recurrent or metastatic head and neck squamous cell carcinoma', 'Patients', 'R/M HNSCC patients', 'recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC', 'n=247), or SoC (n=249']","['durvalumab', 'SoC', 'durvalumab [10 mg/kg every 2 weeks (Q2W)], durvalumab plus tremelimumab (durvalumab 20 mg/kg Q4W plus tremelimumab 1 mg/kg Q4W × 4, then durvalumab 10 mg/kg Q2W), or SoC (cetuximab, a taxane, methotrexate or a fluoropyrimidine', 'Durvalumab with or without tremelimumab', 'durvalumab plus tremelimumab']","['progression-free survival (PFS), objective response rate, and duration of response', 'hypothyroidism for durvalumab and durvalumab plus tremelimumab', 'anemia', 'higher survival rates', '12-month survival rates', 'OS', 'trAE rates', 'overall survival (OS) for durvalumab versus SoC, and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",,0.104994,There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC.,"[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'Department of Otolaryngology, UPMC Hillman Cancer Center, Pittsburgh, USA. Electronic address: ferrrl@UPMC.EDU.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Head and Neck Department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Omsk Regional Oncology Dispensary, Omsk, Omskaya, Russian Federation.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Ion Chiricuta Institute of Oncology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesia', 'Affiliation': ""Catalan Institute of Oncology, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kutukova', 'Affiliation': 'Chemotherapy Department, SPb SBIH City Clinical Oncology Dispensary, Saint Petersburg, Russian Federation.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zholudeva', 'Affiliation': 'Regional Transcarpathian Oncological Dispensary, Uzhgorod, Ukraine.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daste', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Caballero-Daroqui', 'Affiliation': 'Department of Oncology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Keam', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Sumy State University, Sumy Regional Oncology Center, Sumy, Ukraine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Department of Oncology, Clinique Victor Hugo/Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shetty', 'Affiliation': 'Late-stage ImmunoOncology, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Late-stage ImmunoOncology, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wildsmith', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Morsli', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head & Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori Milano, University of Milan, Milan, Italy. Electronic address: lisa.licitra@istitutotumori.mi.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.001']
244,32275468,Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study.,"PURPOSE


Single-agent PD-1 blockade exhibits limited efficacy in epithelial ovarian cancer (EOC). We evaluated ipilimumab plus nivolumab compared with nivolumab alone in women with persistent or recurrent EOC.
METHODS


Eligibility criteria included measurable disease, 1-3 prior regimens, and platinum-free interval (PFI) < 12 months. Participants were randomly allocated to intravenous nivolumab (every 2 weeks) or induction with nivolumab plus ipilimumab for 4 doses (every 3 weeks), followed by every-2-week maintenance nivolumab for a maximum of 42 doses. The primary null hypothesis was equal probability of objective response within 6 months of random allocation in each arm.
RESULTS


One hundred patients were allocated to receive either nivolumab (n = 49), or nivolumab plus ipilimumab (n = 51), with PFI of < 6 months in 62%. Six (12.2%) responses occurred within 6 months in the nivolumab group and 16 (31.4%) in the nivolumab plus ipilimumab group (odds ratio, 3.28; 85% CI, 1.54 to infinity;  P  = .034). The median progression-free survival (PFS) was 2 and 3.9 months in the nivolumab and nivolumab plus ipilimumab groups, respectively, with a PFI-stratified hazard ratio of 0.53 (95% CI, 0.34 to 0.82); the respective hazard ratio for death was 0.79 (95% CI, 0.44 to 1.42). Grade ≥ 3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths. PD-L1 expression was not significantly associated with response in either treatment group.
CONCLUSION


Compared with nivolumab alone, the combination of nivolumab and ipilimumab in EOC resulted in superior response rate and longer, albeit limited, PFS, with toxicity of the combination regimen comparable to prior reports. Additional combination studies to enhance durability of the dual regimen are warranted.",2020,"3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths.","['Recurrent or Persistent Ovarian Cancer', 'One hundred patients', 'epithelial ovarian cancer (EOC', 'Eligibility criteria included measurable disease, 1-3 prior regimens, and platinum-free interval (PFI) < 12 months', 'women with persistent or recurrent EOC']","['nivolumab', 'nivolumab plus ipilimumab', 'intravenous nivolumab (every 2 weeks) or induction with nivolumab plus ipilimumab', 'nivolumab alone', 'Nivolumab Versus Nivolumab and Ipilimumab']","['adverse events', 'Grade ≥', 'PD-L1 expression', 'median progression-free survival (PFS', 'respective hazard ratio for death']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",100.0,0.189914,"3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths.","[{'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Zamarin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'Biostatistics and Bioinformatics, Clinical Trial Development Division, NRG Oncology, Roswell Park, Buffalo, NY.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Powell', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': ""NRG Oncology Biospecimen Bank-Columbus, Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Feldman', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Gunderson', 'Affiliation': 'Stephenson Cancer Center, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma; Oklahoma City, OK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'AMITA Health Physicians, Hinsdale, IL.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Hagemann', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University, Saint Louis, MO.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khleif', 'Affiliation': 'The Loop Immuno-oncology Laboratory, Lombardi Comprehensive Cancer Center, Georgetown University Medical School, Washington DC.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02059']
245,32118463,Correcting exaggerated drinking norms with a mobile message delivery system: Selective prevention with heavy-drinking first-year college students.,"Many efficacious interventions designed to reduce college student drinking aim to correct misperceptions of peers' drinking behavior. The present study tested the efficacy of a novel delivery strategy, namely text messages, for promoting promoderation descriptive and injunctive drinking norms. Participants included 121 college students who were randomly assigned to receive daily text messages containing accurate drinking norms (experimental group,  n  = 61) or historical facts (control group,  n  = 60) for 10 weeks following a baseline assessment. Participants completed 3-month postbaseline and 6-month postbaseline follow-up assessments. The 3-month assessment revealed that promoderation text messages were effective for reducing peak consumption and alcohol consequences. Changes in descriptive norms and injunctive norms aligned with these two behavioral outcomes. The intervention group reported perceiving others as drinking less on their heaviest drinking day and perceived others as being less approving of alcohol-related consequences than the control group. The intervention group also reported more peer approval of using protective behavioral strategies. Yet intervention effects were not maintained. None of the outcome measures differed by condition at the 6-month postbaseline assessment. Thus, the intervention had short-term effects on self-reported drinking behavior as well as on perceptions of drinking norms. However, the behavioral changes were not maintained when participants were assessed in the second semester after the daily text messages intervention had stopped. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Thus, the intervention had short-term effects on self-reported drinking behavior as well as on perceptions of drinking norms.","[""college student drinking aim to correct misperceptions of peers' drinking behavior"", 'Participants included 121 college students', 'heavy-drinking first-year college students']","['daily text messages containing accurate drinking norms (experimental group,  n  = 61) or historical facts (control']",['peak consumption and alcohol consequences'],"[{'cui': 'C4042862', 'cui_str': 'University Student Drinking'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",121.0,0.0280408,"Thus, the intervention had short-term effects on self-reported drinking behavior as well as on perceptions of drinking norms.","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Department of Behavioral and Social Sciences and Center for Alcohol and Addiction Studies, Brown University School of Public Health.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Merrill', 'Affiliation': 'Department of Behavioral and Social Sciences and Center for Alcohol and Addiction Studies, Brown University School of Public Health.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Boyle', 'Affiliation': 'Department of Behavioral and Social Sciences and Center for Alcohol and Addiction Studies, Brown University School of Public Health.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Department of Behavioral and Social Sciences and Center for Alcohol and Addiction Studies, Brown University School of Public Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000566']
246,31211964,Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function.,"BACKGROUND


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


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


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


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


There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.",2019,There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months.,"['women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation', 'women with refractory UUI treated with onabotulinumtoxinA (n=190) or sacral neuromodulation (n=174', 'Women with refractory urgency urinary incontinence', 'refractory urgency urinary incontinence']","['Sacral Neuromodulation versus OnabotulinumtoxinA', 'onabotulinumtoxinA or sacral neuromodulation', 'BTX and SNM']","['fecal incontinence and sexual symptoms', 'Sexual symptoms', 'fecal incontinence symptoms', 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR', 'Fecal incontinence symptoms', 'mild fecal incontinence symptoms', 'proportion of sexually active women', 'change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12 and PISQ-IR scores', 'Fecal Incontinence and sexual symptoms', 'mean Vaizey scores', 'mean PISQ-12 score', 'fecal incontinence symptom score (Vaizey', ""St Mark's (Vaizey) Fecal Incontinence severity scale"", 'PISQ-IR subscores', 'sexual symptom subscores', 'change in Vaizey and PISQ-12 scores', 'sexual symptoms score', 'fecal incontinence symptoms and sexual function', 'fecal incontinence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.194101,There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months.,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Honeycutt', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': 'Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology Kaiser Permanente, San Diego, California.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradley', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Department of Urology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.06.018']
247,32294620,Hydration Does Not Change Postexercise Hypotension and Its Mechanisms.,"BACKGROUND


Drinking water is recommended before and after exercise to avoid dehydration. However, water ingestion may mitigate or prevent postexercise hypotension. This study investigated the effects of intentional hydration on postaerobic exercise hemodynamics and autonomic modulation.
METHODS


A total of 18 young men randomly underwent 4 experimental sessions as follows: (1) control with intentional hydration (1 L of water in the previous night, 500 mL 60 min before the intervention, and 1 mL for each 1 g of body mass lost immediately after the intervention); (2) control without intentional hydration (ad libitum water ingestion before the intervention); (3) exercise (cycle ergometer, 45 min, 50% of VO2peak) with intentional hydration; and (4) exercise without intentional hydration. Hemodynamic and autonomic parameters were measured before and after the interventions and were compared by 3-way analysis of variance.
RESULTS


Intentional hydration did not change any postexercise hemodynamic nor autonomic response. Exercise decreased systolic blood pressure and stroke volume (-4.1 [0.8] mm Hg and -4.9 [1.5] mL, P < .05), while increased cardiac sympathovagal balance (0.3 [0.3], P < .05) during the recovery. In addition, it abolished the increase in diastolic blood pressure and the decrease in heart rate observed in the control sessions.
CONCLUSION


Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.",2020,Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.,['18 young men randomly underwent 4 experimental sessions as follows: '],"['intentional hydration (1\xa0L of water in the previous night, 500\xa0mL 60\xa0min before the intervention, and 1\xa0mL for each 1\xa0g of body mass lost immediately after the intervention); (2)\xa0control without intentional hydration (ad libitum water ingestion before the intervention); (3)\xa0exercise (cycle ergometer, 45\xa0min, 50% of VO2peak) with intentional hydration; and (4)\xa0exercise without intentional hydration', 'intentional hydration']","['postexercise hypotension', 'postexercise hemodynamic nor autonomic response', 'diastolic blood pressure', 'systolic blood pressure and stroke volume', 'hypotensive effect', 'heart rate', 'Hemodynamic and autonomic parameters', 'cardiac sympathovagal balance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.023411,Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.,"[{'ForeName': 'Fernando S', 'Initials': 'FS', 'LastName': 'Lobo', 'Affiliation': ''}, {'ForeName': 'Andreia C C', 'Initials': 'ACC', 'LastName': 'Queiroz', 'Affiliation': ''}, {'ForeName': 'Natan D', 'Initials': 'ND', 'LastName': 'Silva Junior', 'Affiliation': ''}, {'ForeName': 'Fabio L', 'Initials': 'FL', 'LastName': 'Medina', 'Affiliation': ''}, {'ForeName': 'Luiz A R', 'Initials': 'LAR', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Tinucci', 'Affiliation': ''}, {'ForeName': 'Claudia L M', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0476']
248,32079885,Volar Plate Fixation in Adults with a Displaced Extra-Articular Distal Radial Fracture Is Cost-Effective.,"BACKGROUND


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


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


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


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


Economic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]).","['Ninety patients', 'Adults with a Displaced Extra-Articular Distal Radial Fracture', 'patients who had paid employment', 'patients with a displaced extra-articular distal radial fracture', 'adults with a displaced extra-articular distal radial fracture']","['Volar Plate Fixation', 'plaster immobilization', 'volar plate fixation or plaster immobilization', 'volar plate fixation']","['costs per QALY favored volar plate fixation', 'mean total costs', 'mean quality-adjusted life-years (QALYs', 'costs per QALY']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",90.0,0.154195,"The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]).","[{'ForeName': 'Marjolein A M', 'Initials': 'MAM', 'LastName': 'Mulders', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique M J', 'Initials': 'MMJ', 'LastName': 'Walenkamp', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00597']
249,32183265,Assessment of the Simultaneous Use of Biomaterials in Transalveolar Sinus Floor Elevation: Prospective Randomized Clinical Trial in Humans.,"Implants inserted in the posterior maxilla frequently need additional surgery for successful bone augmentation. One of the most common procedures for this is transalveolar sinus floor elevation. There are different protocols for this procedure, and there is controversy over the simultaneous application of grafting material upon elevating. In this prospective randomized clinical study in humans, a total of 49 transalveolar sinus floor elevations were performed in 49 different patients, divided into a control group (without graft, 25 patients) and a test group (with graft, 24 patients). The analyzed variables were obtained through digital orthopantomography on day 0 (day of surgery) and 18 months after surgery. These measurements showed a tendency towards greater vertical bone gain in the test group, but this was not statistically significant. Therefore, considering that sinus elevation and implant placement without the application of grafts is a successful treatment with fewer complications, a critical assessment of the need for these biomaterials is necessary.",2020,"These measurements showed a tendency towards greater vertical bone gain in the test group, but this was not statistically significant.","['humans, a total of 49 transalveolar sinus floor elevations were performed in 49 different patients, divided into a control group (without graft, 25 patients) and a test group (with graft, 24 patients', 'Transalveolar Sinus Floor Elevation']",[],['vertical bone gain'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",49.0,0.0411561,"These measurements showed a tendency towards greater vertical bone gain in the test group, but this was not statistically significant.","[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Maximiano Millán', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Bravo Álvarez', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Plana Montori', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guerrero González', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saura García-Martín', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Ríos-Carrasco', 'Affiliation': 'Advanced Periodontics, School of Dentistry, Universidad de Sevilla, C/Avicena S/N, 41009 Sevilla, Spain.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Monticelli', 'Affiliation': 'Periodontics, Faculty of Health and Sport Sciences, Universidad de Zaragoza, C/Velódromo S/N, 22006 Huesca, Spain.'}, {'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'Ríos-Santos', 'Affiliation': 'Advanced Periodontics, School of Dentistry, Universidad de Sevilla, C/Avicena S/N, 41009 Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández-Palacín', 'Affiliation': 'Department. of Sociosanitary Sciences Facultad de Medicina, Universidad de Sevilla, Avda. Dr. Fedriani, S/N, 41009 Sevilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17061888']
250,32156071,Gut Microbial Protein Expression in Response to Dietary Patterns in a Controlled Feeding Study: A Metaproteomic Approach.,"Although the gut microbiome has been associated with dietary patterns linked to health, microbial metabolism is not well characterized. This ancillary study was a proof of principle analysis for a novel application of metaproteomics to study microbial protein expression in a controlled dietary intervention. We measured the response of the microbiome to diet in a randomized crossover dietary intervention of a whole-grain, low glycemic load diet (WG) and a refined-grain, high glycemic load diet (RG). Total proteins in stools from 9 participants at the end of each diet period ( n  = 18) were analyzed by LC MS/MS and proteins were identified using the Human Microbiome Project (HMP) human gut microbiome database and UniProt human protein databases. T-tests, controlling for false discovery rate (FDR) <10%, were used to compare the Gene Ontology (GO) biological processes and bacterial enzymes between the two interventions. Using shotgun proteomics, more than 53,000 unique peptides were identified including microbial (89%) and human peptides (11%). Forty-eight bacterial enzymes were statistically different between the diets, including those implicated in SCFA production and degradation of fatty acids. Enzymes associated with degradation of human mucin were significantly enriched in the RG diet. These results illustrate that the metaproteomic approach is a valuable tool to study the microbial metabolism of diets that may influence host health.",2020,"Forty-eight bacterial enzymes were statistically different between the diets, including those implicated in SCFA production and degradation of fatty acids.",[],"['whole-grain, low glycemic load diet (WG) and a refined-grain, high glycemic load diet (RG']","['SCFA production and degradation of fatty acids', 'Gene Ontology (GO) biological processes and bacterial enzymes', 'degradation of human mucin', 'false discovery rate (FDR']",[],"[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0033268'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1138831', 'cui_str': 'Gene Ontology'}, {'cui': 'C3714634', 'cui_str': 'Biological Processes'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",18.0,0.0127032,"Forty-eight bacterial enzymes were statistically different between the diets, including those implicated in SCFA production and degradation of fatty acids.","[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Institute of Molecular Medicine, the University of Texas Health Science Center at Houston, Houston, TX 77030, USA.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA 98105, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Institute of Molecular Medicine, the University of Texas Health Science Center at Houston, Houston, TX 77030, USA.'}, {'ForeName': 'Damon H', 'Initials': 'DH', 'LastName': 'May', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98105, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Noble', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98105, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA 98109, USA.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, TX 77030, USA.'}]",Microorganisms,['10.3390/microorganisms8030379']
251,32289824,Exposure to Odors Increases Pain Threshold in Chronic Low Back Pain Patients.,"OBJECTIVES


Structured exposure to odors is an acknowledged therapy in patients with smell loss but has also been shown to be effective in depression. The latter might rely on connections between olfactory and emotional structures, suggesting possible effects of a similar approach in pain patients. Based on neuroanatomy, there are several interfaces between the ""pain matrix"" and olfactory system, such as the limbic system, hypothalamus, and mediodorsal thalamus. We aimed to investigate whether structured exposure to odors may impact perceived pain in patients with chronic low back pain.
DESIGN


Randomized controlled parallel-group design. Subjects were tested on two occasions, at baseline and after four weeks.
SETTING


Ambulatory.
SUBJECTS


Forty-two patients with chronic low back pain.
METHODS


For all patients, olfactory function (using the ""Sniffin'Sticks"" test kit), detection, and pain thresholds for cutaneous electrical stimuli (applied to the forearm) were tested at baseline and after four weeks. Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group). Control patients (N = 14) underwent no such ""olfactory training"" (nontraining group).
RESULTS


Pain thresholds were significantly increased in patients who performed olfactory training compared with patients who did not train with odors. Detection thresholds and olfactory function remained unchanged.
CONCLUSIONS


The present results indicate that regular exposure to odors increases pain thresholds in patients with chronic back pain and could be useful for general pain control in these patients. Furthermore, olfactory training in chronic pain patients might help to reduce chronification of pain by desensitization.",2020,"Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group).","['Forty-two patients with chronic low back pain', 'patients with smell loss', 'pain patients', 'Chronic Low Back Pain Patients', 'patients with chronic low back pain', 'Control patients (N\u2009=\u200914) underwent', 'chronic pain patients', 'patients with chronic back pain']","['olfactory training', 'no such ""olfactory training"" (nontraining group']","['pain thresholds', 'Pain thresholds', 'Detection thresholds and olfactory function']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",42.0,0.0246577,"Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group).","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Gossrau', 'Affiliation': 'University Pain Center, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Baum', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Carl Gustav Carus, University Hospital, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sabatowski', 'Affiliation': 'University Pain Center, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Haehner', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa072']
252,32291838,The psychological and behavioural effects of an animal-assisted therapy programme in Korean older adults with dementia.,"AIM


The purpose of this study was to investigate the psychological and behavioural effects of animal-assisted therapy on cognitive function, emotional state, problematic behaviours, and activities of daily living among older adults with dementia.
METHODS


A nonequivalent control group pretest and post-test study design was used in this study. Twenty-eight participants-14 in the intervention group and 14 in the control group-were recruited from two hospitals in Gyeonggi Province, South Korea, between February and April 2015. The intervention group received two 60-min sessions of animal-assisted therapy weekly for 8 weeks, while the control group received conventional care. The cognitive function, emotional state (mood, depression), activities of daily living, and problematic behaviours of the two groups were compared at three points (before the study, at week 4, and at week 8).
RESULTS


The results showed significant group-by-time interactions of cognitive function (P < 0.001), mood status (P < 0.001), depressive symptoms (P < 0.01), degrees of activities of daily living (P < 0.001), and problematic behaviours (P < 0.001). There were no significant group differences, but significant time differences were observed in cognitive function (P < 0.001), mood status (P < 0.05), degrees of activities of daily living (P < 0.01), and problematic behaviours (P < 0.05).
CONCLUSION


The findings of the study suggest the adoption of animal-assisted therapy in the daily care of older adults with dementia for improving their psychological and behavioural problems.",2020,"There were no significant group differences, but significant time differences were observed in cognitive function (P < 0.001), mood status (P < 0.05), degrees of activities of daily living (P < 0.01), and problematic behaviours (P < 0.05).
","['older adults with dementia', 'Twenty-eight participants-14 in the intervention group and 14 in the control group-were recruited from two hospitals in Gyeonggi Province, South Korea, between February and April 2015', 'older adults with dementia for improving their psychological and behavioural problems', 'Korean older adults with dementia']","['60-min sessions of animal-assisted therapy weekly for 8\u2009weeks, while the control group received conventional care', 'animal-assisted therapy programme', 'animal-assisted therapy']","['problematic behaviours', 'cognitive function, emotional state (mood, depression), activities of daily living, and problematic behaviours', 'cognitive function, emotional state, problematic behaviours, and activities of daily living', 'degrees of activities of daily living', 'cognitive function', 'time interactions of cognitive function', 'mood status', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0150133', 'cui_str': 'Animal-assisted therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0572297,"There were no significant group differences, but significant time differences were observed in cognitive function (P < 0.001), mood status (P < 0.05), degrees of activities of daily living (P < 0.01), and problematic behaviours (P < 0.05).
","[{'ForeName': 'Seung-Min', 'Initials': 'SM', 'LastName': 'Baek', 'Affiliation': 'Department of Nursing, Nurse Manager, Yeoju Geriatric Hospital, Yeoju, South Korea.'}, {'ForeName': 'Yaelim', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, College of Nursing, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Kyeong-Yae', 'Initials': 'KY', 'LastName': 'Sohng', 'Affiliation': 'Department of Nursing, College of Nursing, The Catholic University of Korea, Seoul, South Korea.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12554']
253,31712330,Changes in alcohol consumption after treatment for depression: a secondary analysis of the Swedish randomised controlled study REGASSA.,"OBJECTIVES


Mental health problems and hazardous alcohol consumption often co-exist. Hazardous drinking could have a negative impact on different aspects of health and also negatively influence the effect of mental health treatment. The aims of this study were to examine if alcohol consumption patterns changed after treatment for depression and if the changes differed by treatment arm and patient sex.
METHODS


This study of 540 participants was conducted in a large randomised controlled trial (RCT) that aimed to compare the effect of internet-based cognitive behavioural therapy, physical exercise and treatment as usual on 945 participants with mild-to-moderate depression. Treatment lasted for 12 weeks; alcohol consumption (Alcohol Use Disorder Identification Test (AUDIT)) and depression (Montgomery Åsberg Depression Rating Scale (MADRS)) were assessed at baseline and 12-month follow-up. Changes in alcohol consumption were examined in relation to depression severity, treatment arm and patient sex.
RESULTS


The AUDIT distribution for the entire group remained unchanged after treatment for depression. Hazardous drinkers exhibit decreases in AUDIT scores, although they remained hazardous drinkers according to the cut-off scores. Hazardous drinkers experienced similar improvements in symptoms of depression compared with non-hazardous drinkers, and there was no significant relation between changes in AUDIT score and changes in depression. No differences between treatment arm and patient sex were found.
CONCLUSION


The alcohol consumption did not change, despite treatment effects on depression. Patients with depression should be screened for hazardous drinking habits and offered evidence-based treatment for hazardous alcohol use where this is indicated.
TRIAL REGISTRATION NUMBER


DRKS00008745.",2019,"Hazardous drinkers experienced similar improvements in symptoms of depression compared with non-hazardous drinkers, and there was no significant relation between changes in AUDIT score and changes in depression.","['depression', '945 participants with mild-to-moderate depression', 'Patients with depression', 'Mental health problems and hazardous alcohol consumption often co-exist', '540 participants']","['internet-based cognitive behavioural therapy, physical exercise']","['alcohol consumption (Alcohol Use Disorder Identification Test (AUDIT)) and depression (Montgomery Åsberg Depression Rating Scale (MADRS', 'alcohol consumption', 'alcohol consumption patterns', 'symptoms of depression']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",945.0,0.115842,"Hazardous drinkers experienced similar improvements in symptoms of depression compared with non-hazardous drinkers, and there was no significant relation between changes in AUDIT score and changes in depression.","[{'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Strid', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden catharina.strid@psy.lu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Department of Public Health Science, Section of Epidemiology and Public Health Intervention Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Public Health Science, Section of Epidemiology and Public Health Intervention Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kraepelien', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychiatry, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Öjehagen', 'Affiliation': 'Department of Clinical Science, Lund, Division of Psychiatry, Lund University, Lund, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-028236']
254,31678935,"A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study).","INTRODUCTION


Obesity is a public health concern that is becoming increasingly more serious worldwide. Effective and sustainable childhood obesity prevention strategies may help to reduce the prevalence of obesity and may have an impact on lifelong health. However, few such strategies have been rigorously evaluated for Chinese children in different regions of China.
METHODS AND ANALYSIS


The Diet, ExerCIse and CarDiovascular hEalth-Children is a cluster-randomised controlled trial that aims to assess the effectiveness and sustainability of a school-based, multi-faceted intervention to prevent obesity among Grade 4 primary school students (8-10 years old) in China. Twenty-four schools (approximately 1200 students) from above average, average and below average developed regions in China will be randomised to an intervention (12 schools) or usual practice (12 schools) group. The intervention will last for one school year (9 months) and consists of activities towards students, parents and school environment. A smartphone application will be used to assist in providing information on, monitoring and providing feedback on the behaviours and body weight of the students. Data will be collected at baseline, 4 months, 9 months and 21 months. The primary outcome will be the difference between groups in the change in students' body mass index at 9 months after the baseline investigation. The secondary outcomes will include the differences between groups in the changes in anthropometric measures, diet, physical activity levels and other measures at the follow-up visits. A variety of process evaluation methods will be used to evaluate the implementation process of the complex intervention.
ETHICS AND DISSEMINATION


This study was approved by the Peking University Institution Review Board (IRB00001052-18021). The results will be disseminated through publication in peer-reviewed journals, presentations at conferences and in lay summaries provided to school staff and participants.
TRIAL REGISTRATION NUMBER


NCT03665857.",2019,"The secondary outcomes will include the differences between groups in the changes in anthropometric measures, diet, physical activity levels and other measures at the follow-up visits.","['children', 'Twenty-four schools (approximately 1200 students) from above average, average and below average developed regions in China will be randomised to an intervention (12 schools) or usual practice (12 schools) group', 'obesity among Grade 4 primary school students (8-10 years old) in China', 'Chinese children in different regions of China']","['school-based, multi-faceted intervention']","[""students' body mass index"", 'anthropometric measures, diet, physical activity levels and other measures at the follow-up visits']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]",,0.149282,"The secondary outcomes will include the differences between groups in the changes in anthropometric measures, diet, physical activity levels and other measures at the follow-up visits.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Niu', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Urumqi Primary and Secondary School Health Care Center, Urumqi, China.'}, {'ForeName': 'Aiyu', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Dongcheng Primary and Secondary School Health Care Center, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Mentougou Primary and Secondary School Health Care Center, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China whjun@pku.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027902']
255,31699716,mHealth tool to improve community health agent performance for child development: study protocol for a cluster-randomised controlled trial in Peru.,"INTRODUCTION


Cultivating child health and development creates long-term impact on the well-being of the individual and society. The Amazon of Peru has high levels of many risk factors that are associated with poor child development. The use of 'community health agents' (CHAs) has been shown to be a potential solution to improve child development outcomes. Additionally, mobile information and communication technology (ICT) can potentially increase the performance and impact of CHAs. However, there is a knowledge gap in how mobile ICT can be deployed to improve child development in low resource settings.
METHODS AND ANALYSIS


The current study will evaluate the implementation and impact of a tablet-based application that intends to improve the performance of CHAs, thus improving the child-rearing practices of caregivers and ultimately child health and development indicators. The CHAs will use the app during their home visits to record child health indicators and present information, images and videos to teach key health messages. The impact will be evaluated through an experimental cluster randomised controlled trial. The clusters will be assigned to the intervention or control group based on a covariate-constrained randomisation method. The impact on child development scores, anaemia and chronic malnutrition will be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on implementation outcomes. The study will be implemented in the Amazon region of Peru with children under 4. The results of the study will provide evidence on the potential of a mHealth tool to improve child health and development indicators in the region.
ETHICS AND DISSEMINATION


The study received approval from National Hospital 'San Bartolome' Institutional Ethics Committee on 8 November 2018 (IRB Approval #15463-18) and will be disseminated via peer-reviewed publications.
TRIAL REGISTRATION NUMBER


ISRCTN43591826.",2019,"The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services.","['Amazon region of Peru with children under 4', 'child development']","[""community health agents' (CHAs"", 'mobile information and communication technology (ICT']","['knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services', 'child development scores, anaemia and chronic malnutrition']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]",,0.112936,"The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services.","[{'ForeName': 'Christopher Michael', 'Initials': 'CM', 'LastName': 'Westgard', 'Affiliation': 'Department of Maternal and Child Health, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, USA cmwestgard@unc.edu.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rivadeneyra', 'Affiliation': 'Elementos, Lima, Peru.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Cape Town, South Africa.'}]",BMJ open,['10.1136/bmjopen-2018-028361']
256,31727642,TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol.,"INTRODUCTION


Severe acute malnutrition (SAM) in children in many countries still carries unacceptably high mortality, especially when complicated by secondary infection or metabolic derangements. New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.
METHODS AND ANALYSIS


The TAME trial (Therapeutic Approaches for Malnutrition Enteropathy) will evaluate four novel treatments in an efficient multi-arm single-blind phase II design. In three hospitals in Zambia and Zimbabwe, 225 children with SAM will be randomised to one of these treatments or to standard care, once their inpatient treatment has reached the point of transition from stabilisation to increased nutritional intake. The four interventions are budesonide, bovine colostrum or N-acetyl glucosamine given orally or via nasogastric tube, or teduglutide given by subcutaneous injection. The primary endpoint will be a composite score of faecal inflammatory markers, and a range of secondary endpoints include clinical and laboratory endpoints. Treatments will be given daily for 14 days, and evaluation of the major endpoints will be at 14 to 18 days, with a final clinical evaluation at 28 days. In a subset of children in Zambia, endoscopic biopsies will be used to evaluate the effect of interventions in detail.
ETHICS AND DISSEMINATION


The study has been approved by the University of Zambia Biomedical Research Ethics Committee (006-09-17, dated 9 th  July, 2018), and the Joint Research Ethics Committee of the University of Zimbabwe (24 th  July, 2019). Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and to caregivers at face-to-face meetings.
TRIAL REGISTRATION NUMBER


NCT03716115; Pre-results.",2019,"New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.
","['In three hospitals in Zambia and Zimbabwe, 225 children with SAM', 'malnutrition enteropathy in Zambia and Zimbabwe - a study protocol']","['budesonide, bovine colostrum or N-acetyl glucosamine given orally or via nasogastric tube, or teduglutide given by subcutaneous injection']","['composite score of faecal inflammatory markers, and a range of secondary endpoints include clinical and laboratory endpoints']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0021831', 'cui_str': 'Intestinal Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0442474', 'cui_str': 'Via nasogastric tube (qualifier value)'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",225.0,0.13038,"New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Barts and The London School of Medicine, Queen Mary University of London, London, UK m.p.kelly@qmul.ac.uk.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Amadi', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Mutsa', 'Initials': 'M', 'LastName': 'Bwakura-Dangarembizi', 'Affiliation': 'Department of Paediatrics and Child Health, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'VanBuskirk', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Chandwe', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Miyoba', 'Initials': 'M', 'LastName': 'Chipunza', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Deophine', 'Initials': 'D', 'LastName': 'Ngosa', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Nivea', 'Initials': 'N', 'LastName': 'Chulu', 'Affiliation': 'University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hill', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murch', 'Affiliation': 'University Hospital Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Playford', 'Affiliation': 'Barts and The London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Barts and The London School of Medicine, Queen Mary University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027548']
257,31753866,"Effects of supervised exercise training during pregnancy on psychological well-being among overweight and obese women: secondary analyses of the ETIP-trial, a randomised controlled trial.","OBJECTIVES


Women with high body mass index (BMI) have increased risk for symptoms of anxiety and depression during pregnancy and postpartum. In this prespecified secondary analysis from the exercise training in pregnancy trial, our aim was to examine effects of supervised exercise during pregnancy on psychological well-being in late pregnancy and postpartum among women with a prepregnancy BMI ≥28 kg/m 2 .
DESIGN


Single-centre, parallel group, randomised controlled trial.
SETTING


University Hospital, Norway.
PARTICIPANTS


Ninety-one women (age 31.2±4.1 years, BMI 34.5±4.2 kg/m 2 ), 46 in the exercise group, 45 in the control group, were included in the trial.
INTERVENTION


The exercise group was offered 3 weekly supervised exercise sessions (35 min of moderate intensity walking/running and 25 min of resistance training), until delivery.
PRIMARY AND SECONDARY OUTCOMES MEASURES


Primary analyses were based on intention to treat, with secondary perprotocol analyses. To assess psychological well-being, we used the 'Psychological General Well-Being Index' (PGWBI) at inclusion (gestational week 12-18), late pregnancy (gestational week 34-37) and 3 months postpartum. We assessed postpartum depression using the 'Edinburgh Postnatal Depression Scale' (EPDS).
RESULTS


Numbers completed data collection: late pregnancy 72 (exercise 38, control 36), postpartum 70 (exercise 36, control 34). In the exercise group, 50% adhered to the exercise protocol. Baseline PGWBI for all women was 76.4±12.6. Late pregnancy PGWBI; exercise 76.6 (95% CI 72.2 to 81.0), control 74.0 (95% CI 69.4 to 78.5) (p=0.42). Postpartum PGWBI; exercise 85.4 (95% CI 81.9 to 88.8), control 84.6 (95% CI 80.8 to 88.4) (with no between-group difference, p=0.77). There was no between-group difference in EPDS; exercise 2.96 (95% CI 1.7 to 4.2), control 3.48 (95% CI 2.3 to 4.7) (p=0.55).
CONCLUSIONS


We found no effect of supervised exercise during pregnancy on psychological well-being among women with high BMI. Our findings may be hampered by low adherence to the exercise protocol.
TRIAL REGISTRATION NUMBER


NCT01243554.",2019,"Postpartum PGWBI; exercise 85.4 (95% CI 81.9 to 88.8), control 84.6 (95% CI 80.8 to 88.4) (with no between-group difference, p=0.77).","['University Hospital, Norway', 'women with a prepregnancy BMI ≥28\u2009kg/m 2 ', 'Women with high body mass index (BMI', 'Ninety-one women (age 31.2±4.1 years, BMI 34.5±4.2\u2009kg/m 2 ), 46 in the exercise group, 45 in the control group, were included in the trial', 'women with high BMI', 'overweight and obese women']","['supervised exercise sessions (35\u2009min of moderate intensity walking/running and 25\u2009min of resistance training), until delivery', 'supervised exercise', 'supervised exercise training', 'exercise training']","['EPDS; exercise', ""postpartum depression using the 'Edinburgh Postnatal Depression Scale' (EPDS""]","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}]",91.0,0.194201,"Postpartum PGWBI; exercise 85.4 (95% CI 81.9 to 88.8), control 84.6 (95% CI 80.8 to 88.4) (with no between-group difference, p=0.77).","[{'ForeName': 'Kirsti Krohn', 'Initials': 'KK', 'LastName': 'Garnæs', 'Affiliation': 'Department of Obstetrics and Gynaecology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway kirsti.k.garnas@ntnu.no.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Helvik', 'Affiliation': 'General Practice Research Unit, Department of Public Health and Nursing, NTNU Faculty of Medicine and Health Sciences, Trondheim, Norway.'}, {'ForeName': 'Signe N', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, NTNU Faculty of Medicine and Health Sciences, Trondheim, Norway.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, NTNU Faculty of Medicine and Health Sciences, Trondheim, Norway.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Salvesen', 'Affiliation': 'Department of Obstetrics and Gynaecology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, NTNU Faculty of Medicine and Health Sciences, Trondheim, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU Faculty of Medicine and Health Sciences, Trondheim, Norway.'}]",BMJ open,['10.1136/bmjopen-2018-028252']
258,28922935,"Stereotype threat, trait perseveration, and vagal activity: evidence for mechanisms underpinning health disparities in Black Americans.","Objective:  Black Americans (BAs) are at an elevated risk for morbidity and mortality in comparison to White Americans (WAs). Racial stressors are a common occurrence in American culture and is theorized to contribute to these disparities. When race-focused, stereotype threat (ST) is considered to be a factor that is detrimental to health in BAs; however few studies have directly investigated the impact of a ST manipulation on physiological function. Furthermore, it is proposed that racial stressors such as ST may have prolonged effects when more likely to perseverate (e.g. rumination) over the stressor and thus, those with greater trait perseveration may be more affected by ST. We sought to explore the impact of ST and trait perseveration on changes in vagus nerve activity - an indication of adaptive psychological and physiological well-being - as indexed by vagally mediated heart rate variability (vmHRV).  Design:  Forty-three (24 females, mean age of 20, standard deviation of 3 years) apparently healthy BA individuals were randomly assigned to one of three experimental conditions in which they received either implicit (subtle), explicit (blatant), or no ST priming (control condition), prior to completing a cognitive task. Resting vmHRV was assessed both at baseline (pre-task) and recovery (post-task).  Results:  BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task. BAs with moderate to high levels of trait perseveration showed the greatest decrease in vmHRV from pre- to post-task in comparison to those with lower levels of trait perseveration and BAs in the control group.  Conclusion:  These data suggest that racial ST, especially when explicit and coupled with trait perseveration, can decrease vagal activity, as indexed by decreased vmHRV, which when experienced frequently can have significant consequences for health and longevity in BAs.",2019,"RESULTS


BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task.","['Forty-three (24 females, mean age of 20, standard deviation of 3 years) apparently healthy BA individuals', 'Black Americans (BAs', 'Black Americans']","['implicit (subtle), explicit (blatant), or no ST priming (control condition), prior to completing a cognitive task']","['Resting vmHRV', 'vagal activity', 'vmHRV']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0254408,"RESULTS


BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task.","[{'ForeName': 'DeWayne P', 'Initials': 'DP', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'LaBarron K', 'Initials': 'LK', 'LastName': 'Hill', 'Affiliation': 'Center for the Study of Aging and Human Development, Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Sollers', 'Affiliation': 'Department of Psychology, North Carolina Central University , Durham , NC , USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Vasey', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Baldwin M', 'Initials': 'BM', 'LastName': 'Way', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Thayer', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}]",Ethnicity & health,['10.1080/13557858.2017.1378803']
259,29124951,"The role of serious mental illness in motivation, participation and adoption of health behavior change among obese/sedentary Latino adults.","Objective:  Serious mental illness (SMI; e.g. schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, severe major depressive disorder, and psychotic disorders) and Latino ethnicity can produce a compounded health disparity, placing individuals at particularly high risk for excess morbidity and premature mortality. In this study we sought to identify the role of SMI in motivation, participation, and adoption of health behavior change among overweight Latino adults.  Design:  Qualitative, semi-structured interviews were conducted with 20 overweight Latinos with SMI who were enrolled in a randomized trial evaluating the effectiveness of a motivational health promotion intervention adapted for persons with SMI, In SHAPE. The interviews explored the complicated role having an SMI had in the lives of the Latino participants.  Results:  SMI had both positive and negative impact on Latino participants' health behaviors. The nature of their mental illness along with medication side effects (e.g. lethargy, weight gain, etc.) negatively impacted their ability to making lasting health behavior change. However, the regular appointments with various specialists provided them with structure that they otherwise would have lacked and gave them a reason to get out of the house.  Conclusions:  This exploratory research provides insight into the experience of overweight Latinos with SMI and the ways in which SMI impacts their participation in health behavior change. An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.",2019,An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.,"['obese/sedentary Latino adults', 'persons with SMI, In SHAPE', 'overweight Latino adults', '20 overweight Latinos with SMI who were enrolled']",['motivational health promotion intervention'],"[""Latino participants' health behaviors""]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0018687'}]",20.0,0.0307663,An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.,"[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Jimenez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Veterams Affairs Medical Center Miami , Miami , FL , USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bartels', 'Affiliation': 'Dartmouth Centers for Health and Aging, Geisel School of Medicine at Dartmouth , Hanover , NH , USA.'}]",Ethnicity & health,['10.1080/13557858.2017.1390552']
260,31797721,"Growth Hormone Alters Brain Morphometry, Connectivity, and Behavior in Subjects with Fatigue after Mild Traumatic Brain Injury.","Pituitary dysfunction with reduced growth hormone (GH) secretion is common in patients following traumatic brain injury (TBI), and these patients often develop chronic symptoms including fatigue and altered cognition. We examined 18 subjects with a history of mild TBI, fatigue, and insufficient GH secretion. Subjects received GH replacement in a year-long, double-blind, placebo-controlled, crossover study, and were assessed for changes in physical performance, body composition, resting energy expenditure, fatigue, sleep, mood, and neuropsychological status. Additionally, magnetic resonance imaging (MRI) was used to assess changes in brain structure and resting state functional connectivity. GH replacement resulted in decreased fatigue, sleep disturbance, and anxiety, as well as increased resting energy expenditure, improved body composition, and altered perception of submaximal effort when performing exercise testing. Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks. GH replacement altered brain morphology and connectivity and reduced fatigue and related symptoms in mild TBI patients. Additional studies are needed to understand the mechanisms causing TBI-related fatigue and symptom relief with GH replacement.",2020,Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks.,"['mild TBI patients', 'patients following traumatic brain injury (TBI', '18 subjects with a history of mild TBI, fatigue, and insufficient GH secretion', 'Subjects with Fatigue after Mild Traumatic Brain Injury']","['placebo', 'Pituitary dysfunction with reduced growth hormone (GH) secretion', 'GH replacement']","['physical performance, body composition, resting energy expenditure, fatigue, sleep, mood, and neuropsychological testing', 'frontal cortical thickness and gray matter volume and resting state connectivity changes', 'brain structure and resting state functional connectivity', 'brain morphology and connectivity and reduced fatigue and related symptoms', 'fatigue, sleep disturbance, and anxiety, as well as increased resting energy expenditure, improved body composition, and altered perception of sub-maximal effort']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C2607857'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",18.0,0.111479,Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks.,"[{'ForeName': 'Traver', 'Initials': 'T', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Urban', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Durham', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'E Lichar', 'Initials': 'EL', 'LastName': 'Dillon', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Randolph', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Danesi', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gilkison', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Karmonik', 'Affiliation': 'Radiology Department, Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Zgaljardic', 'Affiliation': 'Transitional Learning Center at Galveston, Galveston, Texas.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Masel', 'Affiliation': 'Center for Neuro Skills, Bakersfield, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pyles', 'Affiliation': 'Department of Pediatrics, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Seidler', 'Affiliation': 'Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ashton H', 'Initials': 'AH', 'LastName': 'Hierholzer', 'Affiliation': 'Department of School of Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sheffield-Moore', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}]",Journal of neurotrauma,['10.1089/neu.2019.6690']
261,32160298,Differential effects of phosphate binders on vitamin D metabolism in chronic kidney disease.,"BACKGROUND


Phosphate binders are commonly used in the treatment of patients with hyperphosphatemia. While phosphate binders are used to lower phosphate, the effects of specific phosphate binder types on vitamin D metabolism are unknown.
METHODS


We performed a secondary analysis of the Phosphate Normalization Trial in which patients with moderate to advanced chronic kidney disease were randomized to receive either placebo, sevelamer carbonate, lanthanum carbonate or calcium acetate for 9 months. We evaluated changes in serum concentrations of vitamin D metabolites including 24,25-dihydroxyvitamin D3 [24,25(OH)2D3], 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], the ratio of 24,25(OH)2D3 to 25-hydroxyvitamin D [the vitamin D metabolite ratio (VMR)] and the ratio of serum 1,25(OH)2D to 25-hydroxyvitamin D.
RESULTS


Compared with placebo, randomization to the calcium acetate arm was associated with a 0.6 ng/mL (95% CI 0.2, 1) and 13.5 pg/ng (95% CI 5.5, 21.5) increase in 24,25(OH)2D and VMR, respectively, and a 5.2 pg/mL (95% CI 1.1, 9.4) reduction in 1,25(OH)2D. Randomization to sevelamer carbonate was associated with a 0.5 ng/mL (95% CI -0.9, -0.1) and 11.8 pg/ng (95% CI -20, -3.5) reduction in 24,25(OH)2D3 and VMR, respectively. There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
CONCLUSION


Administration of different phosphate binders to patients with moderate to severe CKD results in unique changes in vitamin D metabolism.",2020,"There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
","['chronic kidney disease', 'patients with moderate to advanced chronic kidney disease', 'patients with hyperphosphatemia', 'patients with moderate to severe CKD']","['placebo, sevelamer carbonate, lanthanum carbonate or calcium acetate', 'lanthanum carbonate', 'phosphate binders']","['vitamin D metabolism', '24,25(OH)2D and VMR', 'serum concentrations of vitamin D metabolites including 24,25-dihydroxyvitamin D3 [24,25(OH)2D3], 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], the ratio of 24,25(OH)2D3 to 25-hydroxyvitamin D [the vitamin D metabolite ratio (VMR)] and the ratio of serum 1,25(OH)2D to 25-hydroxyvitamin D']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007026', 'cui_str': 'Carbonates'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0886858', 'cui_str': '(24R)-24,25-Dihydroxyvitamin D3'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.0844352,"There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ginsberg', 'Affiliation': 'Division of Nephrology-Hypertension, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Nephrology, Reata Pharmaceuticals, Inc., Plano, TX, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Anschutz Medical Center, Aurora, CO, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa010']
262,31326978,Associations of Hearing Loss and Menopausal Hormone Therapy With Change in Global Cognition and Incident Cognitive Impairment Among Postmenopausal Women.,"BACKGROUND


Hearing loss (HL) and menopausal hormone therapy (conjugated equine estrogens [CEE] and/or medroxyprogesterone acetate [MPA]) are separately associated with cognitive decline and increased risk of incident cognitive impairment. Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
METHODS


Using the Women's Health Initiative (WHI) Memory Study, 7,220 postmenopausal women with measures of HL, global cognition (Modified Mini-Mental State Examination score), and cognitive impairment (centrally adjudicated diagnoses of mild cognitive impairment and dementia) from 1996 to 2009. Multivariable linear mixed-effects models were used to analyze rate of change in global cognition. Accelerated failure time models were used to evaluate time to incident cognitive impairment, stratified by HT.
RESULTS


Within the CEE-Alone trial, observed adverse effects of CEE-Alone on change in global cognition did not differ by HL, and estimated joint effects of HL and CEE-Alone were not associated with incident cognitive impairment. Within the CEE+MPA trial, while HL did not independently accelerate time to cognitive impairment, the adverse effect of CEE+MPA on global cognition was heightened in older women with HL. Older women on CEE+MPA either with HL (time ratio [TR] = 0.82, 95% confidence interval [CI]: 0.71, 0.94) or with normal hearing (TR = 0.86, 95% CI: 0.76, 0.97) had faster time to cognitive impairment than those with normal hearing and placebo.
CONCLUSIONS


HL may accentuate the adverse effect of CEE+MPA, not CEE-Alone, on global cognitive decline, not incident cognitive impairment, among postmenopausal women on HT.",2020,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","['postmenopausal women', '7,220 postmenopausal women with measures of HL, global cognition (Modified Mini- Mental State Examination score), and cognitive impairment (centrally-adjudicated diagnoses of mild cognitive impairment and dementia) from 1996-2009', 'Postmenopausal Women', 'postmenopausal women on HT', 'older women with HL', 'Older women on']","['HL and HT', 'Menopausal Hormone Therapy', 'medroxyprogesterone acetate [MPA', 'CEE+MPA']","['incident cognitive impairment', 'normal hearing', 'rate of change in global cognition', 'global cognition', 'faster time to cognitive impairment']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4304091', 'cui_str': '3MS (Modified Mini-Mental State) Examination score'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.094197,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jiu-Chiuan', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Neurology, Keck School of Medicine of University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Masaki', 'Affiliation': 'Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawai`i Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University of Buffalo, New York.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Deal', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz173']
263,32271377,Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial.,"Importance


Checkpoint inhibitors targeting programmed cell death 1 or its ligand (PD-L1) as monotherapies or in combination with anti-cytotoxic T-lymphocyte-associated antigen 4 have shown clinical activity in patients with metastatic non-small cell lung cancer.
Objective


To compare durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer.
Design, Setting, and Participants


This open-label, phase 3 randomized clinical trial (MYSTIC) was conducted at 203 cancer treatment centers in 17 countries. Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations were randomized to receive treatment with durvalumab, durvalumab plus tremelimumab, or chemotherapy. Data were collected from July 21, 2015, to October 30, 2018.
Interventions


Patients were randomized (1:1:1) to receive treatment with durvalumab (20 mg/kg every 4 weeks), durvalumab (20 mg/kg every 4 weeks) plus tremelimumab (1 mg/kg every 4 weeks, up to 4 doses), or platinum-based doublet chemotherapy.
Main Outcomes and Measures


The primary end points, assessed in patients with ≥25% of tumor cells expressing PD-L1, were overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS) for durvalumab plus tremelimumab vs chemotherapy. Analysis of blood tumor mutational burden (bTMB) was exploratory.
Results


Between July 21, 2015, and June 8, 2016, 1118 patients were randomized. Baseline demographic and disease characteristics were balanced between treatment groups. Among 488 patients with ≥25% of tumor cells expressing PD-L1, median OS was 16.3 months (95% CI, 12.2-20.8) with durvalumab vs 12.9 months (95% CI, 10.5-15.0) with chemotherapy (hazard ratio [HR], 0.76; 97.54% CI, 0.56-1.02; P = .04 [nonsignificant]). Median OS was 11.9 months (95% CI, 9.0-17.7) with durvalumab plus tremelimumab (HR vs chemotherapy, 0.85; 98.77% CI, 0.61-1.17; P = .20). Median PFS was 3.9 months (95% CI, 2.8-5.0) with durvalumab plus tremelimumab vs 5.4 months (95% CI, 4.6-5.8) with chemotherapy (HR, 1.05; 99.5% CI, 0.72-1.53; P = .71). Among 809 patients with evaluable bTMB, those with a bTMB ≥20 mutations per megabase showed improved OS for durvalumab plus tremelimumab vs chemotherapy (median OS, 21.9 months [95% CI, 11.4-32.8] vs 10.0 months [95% CI, 8.1-11.7]; HR, 0.49; 95% CI, 0.32-0.74). Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy. These adverse events led to death in 2 (0.5%), 6 (1.6%), and 3 (0.9%) patients, respectively.
Conclusions and Relevance


The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1. Exploratory analyses identified a bTMB threshold of ≥20 mutations per megabase for optimal OS benefit with durvalumab plus tremelimumab.
Trial Registration


ClinicalT rials.gov Identifier: NCT02453282.",2020,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","['Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations', '369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with', '1118 patients were randomized', '203 cancer treatment centers in 17 countries', 'Metastatic Non-Small Cell Lung Cancer', '488 patients with ≥25% of', '809 patients with evaluable bTMB', 'Data were collected from July 21, 2015, to October 30, 2018', 'patients with metastatic non-small cell lung cancer']","['Durvalumab With or Without Tremelimumab vs Standard Chemotherapy', 'durvalumab, with or without tremelimumab, with chemotherapy', 'chemotherapy', 'durvalumab, durvalumab plus tremelimumab, or chemotherapy', 'durvalumab vs chemotherapy', 'tremelimumab', 'durvalumab', 'platinum-based doublet chemotherapy']","['blood tumor mutational burden (bTMB', 'overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS', 'tumor cells expressing PD-L1, median OS', 'Median PFS', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1118.0,0.235187,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","[{'ForeName': 'Naiyer A', 'Initials': 'NA', 'LastName': 'Rizvi', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology and Oncology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Nederlands Kanker Instituut-Antoni van Leeuwenhoekziekenhuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Smolin', 'Affiliation': 'Department of Radiology, Burdenko Main Military Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'Oncological Clinical Research Center, St Petersburg, Russia.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier Régional Universitaire de Brest-Hôpital Morvan, Brest, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Natale', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Hematology and Oncology, NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Princess Margaret Cancer Centre and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarayut Lucien', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Faculty of Medicine, Department of Medical Oncology, Kindai University, Osaka, Japan.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Raja', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boothman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Luping', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Scheuring', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Vikram K', 'Initials': 'VK', 'LastName': 'Chand', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.0237']
264,31751908,Impact of sleep opportunity on asthma outcomes in adolescents.,"RATIONALE


Insufficient sleep is associated with a number of negative health outcomes; as most adolescents obtain <7 h of sleep per night, it is important to understand how sleep impacts asthma among adolescents.
OBJECTIVES


To examine the impact of sleep opportunity on asthma in adolescents.
METHODS


In this study, 54 adolescents with asthma (12-17 years, 69% female, 65% Caucasian) participated in a randomized, cross-over sleep manipulation trial, including a sleep stabilization week, five nights of a ""Short"" sleep opportunity (time in bed: 6.5 h/night), and five nights of a ""Long"" sleep opportunity (time in bed: 9.5 h/night). Wake times were consistent across all three study weeks. Primary outcomes were lung function (daily peak expiratory flow rate, weekly spirometry) and functional asthma outcomes (daily asthma symptoms, Asthma Control Questionnaire, PROMIS Asthma Impact Scale). Markers of inflammation were also explored.
MEASUREMENTS AND MAIN RESULTS


Compared to the Long sleep week, during the Short sleep week, morning FEV1 was lower (p = 0.006), while asthma symptoms and albuterol use was higher (p < 0.05), and asthma showed a trend towards greater negative impact on daily life (p = 0.07). No differences were found for weekly measures of lung function or inflammation.
CONCLUSIONS


An insufficient sleep opportunity negatively impacts objective and subjective daily symptoms of asthma in adolescents, as well as health related quality of life. As most adolescents are significantly sleep deprived, it is important to target sleep health in the treatment of asthma.",2020,"Compared to the Long sleep week, during the Short sleep week, morning FEV1 was lower (p = 0.006), while asthma symptoms and albuterol use was higher (p < 0.05), and asthma showed a trend towards greater negative impact on daily life (p = 0.07).","['adolescents', 'asthma in adolescents', '54 adolescents with asthma (12-17 years, 69% female, 65% Caucasian']","['sleep stabilization week, five nights of a ""Short"" sleep opportunity (time in bed: 6.5\xa0h/night), and five nights of a ""Long"" sleep opportunity (time in bed: 9.5\xa0h/night']","['lung function or inflammation', 'daily life', 'morning FEV1', 'lung function (daily peak expiratory flow rate, weekly spirometry) and functional asthma outcomes (daily asthma symptoms, Asthma Control Questionnaire, PROMIS Asthma Impact Scale', 'asthma symptoms and albuterol use']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",54.0,0.0244088,"Compared to the Long sleep week, during the Short sleep week, morning FEV1 was lower (p = 0.006), while asthma symptoms and albuterol use was higher (p < 0.05), and asthma showed a trend towards greater negative impact on daily life (p = 0.07).","[{'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Meltzer', 'Affiliation': 'Department of Pediatrics, National Jewish Health, USA. Electronic address: meltzerL@njhealth.org.'}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jump', 'Affiliation': 'Department of Pediatrics, National Jewish Health, USA.'}, {'ForeName': 'Kassie', 'Initials': 'K', 'LastName': 'Flewelling', 'Affiliation': 'Department of Psychology, University of Colorado Denver, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sundström', 'Affiliation': 'Department of Pediatrics, National Jewish Health, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Department of Pediatrics, National Jewish Health, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Zeitlin', 'Affiliation': 'Department of Pediatrics, National Jewish Health, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Strand', 'Affiliation': 'Division of Biostatistics, National Jewish Health, USA.'}]",Sleep medicine,['10.1016/j.sleep.2019.07.014']
265,32282467,"Inhaled methoxyflurane for the management of trauma related pain in patients admitted to hospital emergency departments: a randomised, double-blind placebo-controlled trial (PenASAP study).","BACKGROUND


Oligo-analgesia is common in the emergency department (ED). This study aimed at reporting, when initiated by triage nurse, the superior efficacy of inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC) for moderate-to-severe trauma-related pain in the hospital ED.
METHODS


A randomised, double-blind, placebo-controlled trial was conducted at eight EDs. Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission were randomised to receive one or two inhalers containing m-SoC or p-SoC. Primary outcome measure was time until pain relief ≤30 mm, assessed on the 100-mm Visual Analogic Scale (VAS).
RESULTS


A total of 351 patients were analysed (178 m-SoC; 173 p-SoC). Median pain prior to first inhalation was 66 mm, 75% had severe pain (NRS 6-10). Median time to pain relief was 35 min [95% confidence interval (CI), 28-62] for m-SoC versus not reached in p-SoC (92 - not reached) [hazard ratio), 1.93 (1.43-2.60), P < 0.001]. Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7). As SoC, 24 (7%) patients received weak opioids (6 versus 8%), 4 (1%) strong opioid and 44 (13%) escalated to weak or strong opioids (8 versus 17%, respectively, P = 0.02). Most adverse events were of mild (111/147) intensity.
CONCLUSIONS


In this study, we report that methoxyflurane, initiated at triage nurse as part of a multimodal analgesic approach, is effective in achieving pain relief for trauma patients. This effect was particularly pronounced in the severe pain subgroup.",2020,"Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7).","['patients admitted to hospital emergency departments', 'A total of 351 patients were analysed (178\u2009m-SoC; 173 p-SoC', 'trauma patients', 'Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission']","['inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC', 'Inhaled methoxyflurane', 'placebo', 'methoxyflurane']","['severe pain', 'Median pain', 'Median time to pain relief', 'Pain relief', 'pain relief', 'time until pain relief ≤30\u2009mm, assessed on the 100-mm Visual Analogic Scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",351.0,0.761137,"Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7).","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Ricard-Hibon', 'Affiliation': 'Emergency Department SAMU-SMUR 95, CHG Pontoise-Beaumont/Oise Pontoise.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lecoules', 'Affiliation': 'Emergency Department, CHU Purpan, Toulouse.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Savary', 'Affiliation': 'Emergency Department, Centre Hospitalier Annecy Genevois, Annecy.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Jacquin', 'Affiliation': 'Emergency Department, Hôpital Edouard Herriot, Hospices Civils de Lyon, University Lyon 1 EA 425, Lyon.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wiel', 'Affiliation': 'Emergency Department-SAMU du Nord, CHU Lille, Lille.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Deschamps', 'Affiliation': 'Emergency Department SAMU-SMUR 95, CHG Pontoise-Beaumont/Oise Pontoise.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Douplat', 'Affiliation': 'Emergency Department, Hôpital Lyon Sud Hospices Civils de Lyon, Lyon.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montestruc', 'Affiliation': 'Biometry, eXYSTAT SAS, Malakoff.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Chomier', 'Affiliation': 'Medical affairs, Mundipharma SAS, Paris.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tazarourte', 'Affiliation': 'Emergency Department, Hôpital Edouard Herriot, Hospices Civils de Lyon, University Lyon 1 EA 425, Lyon.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Emergency Department SAMU 93 Inserm U942, AP-HP Hôpital Avicenne l, Bobigny, France.'}]",European journal of emergency medicine : official journal of the European Society for Emergency Medicine,['10.1097/MEJ.0000000000000686']
266,32282472,Endoscopic Endonasal Dacryocystorhinostomy With a Novel Lacrimal Ostium Stent in Chronic Dacryocystitis Cases With Small Lacrimal Sac.,"PURPOSE


To investigate feasibility of endoscopic endonasal dacryocystorhinostomy (EE-DCR) with an novel lacrimal ostium stent (LOS) intubation for patients with chronic dacryocystitis with small lacrimal sac.
METHODS


Patients diagnosed as chronic dacryocystitis with small lacrimal sac who preferred to surgery treatment between March 1st, 2012 and May 1st, 2015. All included subjects were randomly divided into 2 groups (Group A and Group B). Cases in group A were performed EE-DCR with LOS intubation while cases in group B were underwent EE-DCR without LOS intubation. Demographic data of each cases were collected. The success rate and the surgical outcomes of 2 groups were compared.
RESULTS


The success rate was much higher in group A than group B. At 3 months follow up, 61.6% of patients in group A exhibited scarring and/or granulation tissues around the ostium, which was significantly higher than the 36.4% of patients in group B. Of these patients with scars and/or granulation tissues, no statistical difference was found between 2 groups. Granuloma alone and scars with granuloma were observed in 10 patients and 2 patients, in group A and group B, respectively, resulting in a statistical significant difference for this outcome between the groups. At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
CONCLUSIONS


EE-DCR with novel LOS may be an effective procedure to manage chronic dacryocystitis with small lacrimal sac.",2020,"At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
","['Patients diagnosed as chronic dacryocystitis with small lacrimal sac who preferred to surgery treatment between March 1st, 2012 and May 1st, 2015', 'Chronic Dacryocystitis Cases With Small Lacrimal Sac', 'patients with chronic dacryocystitis with small lacrimal sac']","['EE-DCR without LOS intubation', 'Endoscopic Endonasal Dacryocystorhinostomy With a Novel Lacrimal Ostium Stent', 'novel lacrimal ostium stent (LOS) intubation', 'endoscopic endonasal dacryocystorhinostomy (EE-DCR']","['Granuloma alone and scars with granuloma', 'scarring and/or granulation tissues', 'success rate', 'rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma', 'success rate and the surgical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149506', 'cui_str': 'Chronic dacryocystitis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0229289', 'cui_str': 'Lacrimal sac structure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0018188', 'cui_str': 'Granuloma'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.023086,"At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Zhenbin', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Eye Hospital at Hangzhou, Wenzhou Medical University, Hangzhou, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006359']
267,31706187,Cardiovascular events reported in randomized controlled trials in restless legs syndrome.,"OBJECTIVE


Evaluate the frequency of cardiovascular adverse events reported in randomized controlled trials (RCT) in Restless Leg Syndrome (RLS).
METHODS


Databases were searched up to October 2015. Randomized, double-blind, placebo-controlled trials of patients with RLS were included if quantitative data were extractable. The primary outcome was cardiovascular adverse events defined as cardiac diseases, blood pressure abnormalities, syncope, cerebrovascular diseases, thromboembolic events, and sudden death. The pooled estimated prevalence of cardiovascular (CV) adverse events (AE) and respective 95% confidence interval (CI) was determined by using a meta-analysis.
RESULTS


In sum, 28 RCT (2515 participants in the placebo arm and 4223 participants in the intervention arm) reported CV AE. The pooled estimated prevalence of CV AE was 0.61% (95% CI 0.31 to 0.91; I 2  = 0%) in the placebo arm and 0.68% (95%CI 0.40 to 0.96; I 2  = 18.25%) in the intervention arm. The frequency of major CV events (myocardial infarction, stroke and peripheral artery disease) was 0.49% (95%CI 0.22 to 0.77; I 2  = 0%) and 0.33% (95% CI 0.16 to 0.50; I 2  = 0%) in the placebo and intervention arm, respectively.
CONCLUSIONS


The frequency of major cardiovascular events in the RLS trials is not negligible, particularly when considering the young age of these patients.",2020,The pooled estimated prevalence of CV AE was 0.61% (95% CI 0.31 to 0.91; I 2  = 0%) in the placebo arm and 0.68% (95%CI 0.40 to 0.96; I 2  = 18.25%) in the intervention arm.,"['Restless Leg Syndrome (RLS', 'restless legs syndrome', 'patients with RLS']",['placebo'],"['frequency of major cardiovascular events', 'CV AE', 'Cardiovascular events', 'frequency of major CV events (myocardial infarction, stroke and peripheral artery disease', 'prevalence of CV AE', 'cardiovascular adverse events defined as cardiac diseases, blood pressure abnormalities, syncope, cerebrovascular diseases, thromboembolic events, and sudden death', 'cardiovascular (CV) adverse events (AE) and respective 95% confidence interval (CI']","[{'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",2515.0,0.745478,The pooled estimated prevalence of CV AE was 0.61% (95% CI 0.31 to 0.91; I 2  = 0%) in the placebo arm and 0.68% (95%CI 0.40 to 0.96; I 2  = 18.25%) in the intervention arm.,"[{'ForeName': 'Gonçalo S', 'Initials': 'GS', 'LastName': 'Duarte', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal; Serviço de Medicina III, Hospital Pulido Valente, CHLN, Lisbon, Portugal.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Camara', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Caldeira', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal; Serviço de Cardiologia, Hospital Universitário de Santa Maria, CAML, Centro Cardiovascular da Universidade de Lisboa - CCUL, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal; CNS - Campus Neurológico Sénior, Torres Vedras, Portugal. Electronic address: jferreira@medicina.ulisboa.pt.'}]",Sleep medicine,['10.1016/j.sleep.2019.06.022']
268,31706189,Beneficial effects of exercise training on cognitive performances during total sleep deprivation in healthy subjects.,"OBJECTIVE


Exercise training has been shown to improve learning and memory, and to protect against the negative impact of sleep deprivation. The aim of this study was to investigate the effects of seven weeks of moderate- and high-intensity interval exercise training on vigilance/sustained attention, inhibition processes and working memory during 40-h total sleep deprivation (TSD) in 16 healthy young men.
METHODS


The subjects were evaluated before (Baseline, BAS) and during TSD, and the day after a night of recovery sleep (Recovery, REC).
RESULTS


Exercise training significantly decreased errors and increased speed assessed by the psychomotor vigilance task (PVT) during TSD and REC while no difference was found in executive inhibition (Go-noGo task) and working memory (2-Back task) performances. The multiple sleep latency test results were higher during BAS and REC at Post-exercise training, and no difference occurred in subjective sleepiness and daytime microsleeps over the 40-h TSD. The PVT speed was positively correlated with maximal oxygen consumption and maximal aerobic power measured before entry in the in-laboratory TSD protocol, and stage 3 sleep duration measured during the first night in the in-laboratory TSD protocol (N-1). Exercise training effects on sleep were found during the night recovery with lower stage-3 sleep and higher rapid eye movement (REM) sleep durations. An exercise training effect was also found on free insulin-like growth factor I levels with lower levels during TSD at Post-exercise training.
CONCLUSIONS


In healthy young men, exercise training reduced sleep pressure at baseline and protected against sustained attention deficits induced by TSD with persistent effect after one night of recovery sleep. Nevertheless, exercise training was not effective in reducing deficits in executive inhibition and working memory induced by TSD.",2020,"RESULTS


Exercise training significantly decreased errors and increased speed assessed by the psychomotor vigilance task (PVT) during TSD and REC while no difference was found in executive inhibition (Go-noGo task) and working memory (2-Back task) performances.","['16 healthy young men', 'healthy subjects', 'healthy young men']","['Exercise training', '40-h total sleep deprivation (TSD', 'moderate- and high-intensity interval exercise training', 'exercise training']","['subjective sleepiness and daytime microsleeps', 'executive inhibition (Go-noGo task) and working memory (2-Back task) performances', 'free insulin-like growth factor I levels', 'sleep pressure', 'psychomotor vigilance task (PVT', 'cognitive performances', 'deficits in executive inhibition and working memory induced by TSD', 'rapid eye movement (REM) sleep durations', 'maximal oxygen consumption and maximal aerobic power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C4049266', 'cui_str': 'Microsleep'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0487017', 'cui_str': 'Free insulin (substance)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",16.0,0.0255641,"RESULTS


Exercise training significantly decreased errors and increased speed assessed by the psychomotor vigilance task (PVT) during TSD and REC while no difference was found in executive inhibition (Go-noGo task) and working memory (2-Back task) performances.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Sauvet', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France. Electronic address: fabien.sauvet@gmail.com.'}, {'ForeName': 'Pierrick J', 'Initials': 'PJ', 'LastName': 'Arnal', 'Affiliation': ""Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France; Laboratoire de Physiologie de l'Exercice, Université de Lyon, Saint Etienne, France.""}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Tardo-Dino', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Drogou', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Van Beers', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Mégane', 'Initials': 'M', 'LastName': 'Erblang', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Guillard', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Rabat', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Malgoyre', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France.'}, {'ForeName': 'Cyprien', 'Initials': 'C', 'LastName': 'Bourrilhon', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Léger', 'Affiliation': 'EA 7330 VIFASOM, Université de Paris, France; APHP, Hôtel Dieu, Centre du Sommeil et de la Vigilance, Paris, France.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Gomez-Mérino', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Chennaoui', 'Affiliation': 'Institut de recherche biomédicale des armées (IRBA), Brétigny-sur-Orge, France; EA 7330 VIFASOM, Université de Paris, France.'}]",Sleep medicine,['10.1016/j.sleep.2019.07.007']
269,31707288,SIESTA - Home sleep study with BresoDx for obstructive sleep apnea: a randomized controlled trial.,"STUDY OBJECTIVES


The objectives of this study were to evaluate (1) the accuracy of the clinical diagnosis of obstructive sleep apnea (OSA) informed by the home sleep study with a Type 4 portable monitor BresoDx® versus Type 1 polysomnography (PSG); and (2) agreement of the apnea-hypopnea index (AHI) compared between BresoDx and PSG.
MATERIAL AND METHODS


This was a randomized, parallel, multicentre, single-blind, pragmatic controlled trial enrolling adults referred to three Ontario sleep clinics for suspected OSA. Participants were randomized to BresoDx followed by PSG (one-night apart) or PSG followed by BresoDx sleep testing sequence arms. The primary outcomes included the accuracy of clinical diagnosis and OSA severity measured by AHI between tests.
RESULTS


In sum, 233 participants completed both sleep studies and 206 completed physician consultation visits. The agreement between clinical diagnosis informed by PSG versus BresoDx was fair (Cohen's kappa coefficient = 0.28). The sensitivity of BresoDx-informed clinical diagnosis against PSG was between 0.86 and 0.89, and the specificity between 0.38 and 0.44. For AHI cut-off of ≥5 events/hour the sensitivity, specificity and positive and negative predictive values were 0.85, 0.48, 0.81 and 0.54.
CONCLUSIONS


Home sleep apnea testing with BresoDx can be used in a referral population with a high pretest probability of OSA similar to other Type IV devices. This study complements the existing body of evidence suggesting that home testing with portable devices plays a valuable role for diagnosing of OSA in a variety of settings. SIESTA TRIAL REGISTRATION: www.clinicaltrials.gov (Identifier: NCT02003729).",2020,The agreement between clinical diagnosis informed by PSG versus BresoDx was fair (Cohen's kappa coefficient = 0.28).,"['233 participants completed both sleep studies and 206 completed physician consultation visits', 'obstructive sleep apnea', 'adults referred to three Ontario sleep clinics for suspected OSA']","['Type 4 portable monitor BresoDx® versus Type 1 polysomnography (PSG', 'BresoDx followed by PSG (one-night apart) or PSG', 'BresoDx']","['sensitivity of BresoDx-informed clinical diagnosis against PSG', 'accuracy of clinical diagnosis and OSA severity measured by AHI between tests', 'obstructive sleep apnea (OSA', 'apnea-hypopnea index (AHI', 'sensitivity, specificity and positive and negative predictive values']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C0441732', 'cui_str': 'Type 4 (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",233.0,0.105776,The agreement between clinical diagnosis informed by PSG versus BresoDx was fair (Cohen's kappa coefficient = 0.28).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fitzpatrick', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Ontario, Canada. Electronic address: fitzpatm@kgh.kari.net.""}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Ted Rogers Centre for Heart Research, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada; Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mitsakakis', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lusine', 'Initials': 'L', 'LastName': 'Abrahamyan', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada; Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Carcone', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': ""Ba'"", 'Initials': 'B', 'LastName': 'Pham', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Kendzerska', 'Affiliation': 'The Ottawa Hospital Research Institute, University of Ottawa, Canada.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': 'Department of Family Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Gottschalk', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alia', 'Initials': 'A', 'LastName': 'Kashgari', 'Affiliation': 'Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Krahn', 'Affiliation': 'Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Sleep medicine,['10.1016/j.sleep.2019.07.013']
270,30627973,Phytomedicines in the Treatment of Migraine.,"Migraine is a disabling neurovascular disorder with few targeted, tolerable and effective treatments. Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine. Many patients also turn toward herbal and plant-based therapies for the treatment of their migraines as clinical and preclinical evidence of efficacy increases. Patients seek effective and tolerable treatments instead of or in addition to current conventional pharmacologic therapies. We review some phytomedicines potentially useful for migraine treatment-feverfew (Tanacetum parthenium), butterbur (Petasites hybridus), marijuana (Cannabis spp.), Saint John's Wort (Hypericum perforatum) and the Damask rose (Rosa × damascena)-with respect to their mechanisms of action and evidence for treatment of migraine. The evidence for feverfew is mixed; butterbur is effective with potential risks of hepatotoxicity related to preparation; marijuana has not been shown to be effective in migraine treatment, and data are scant; Saint John's Wort shows relevant physiological activity but is a hepatic enzyme inducer and lacks clinical studies for this purpose; the Damask rose when used in topical preparations did not show efficacy in one clinical trial. Other plant preparations have been considered for migraine treatment but most without blinded randomized, placebo-controlled trial evidence.",2019,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.",[],"['Migraine', 'placebo']",[],[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.067028,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.","[{'ForeName': 'Thilinie', 'Initials': 'T', 'LastName': 'Rajapakse', 'Affiliation': 'Division of Neurology, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada. Thilinie.Rajapakse@albertahealthservices.ca.'}, {'ForeName': 'William Jeptha', 'Initials': 'WJ', 'LastName': 'Davenport', 'Affiliation': 'Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",CNS drugs,['10.1007/s40263-018-0597-2']
271,31024557,"Poly-ICLC, a TLR3 Agonist, Induces Transient Innate Immune Responses in Patients With Treated HIV-Infection: A Randomized Double-Blinded Placebo Controlled Trial.","Objective:  Toll-like receptor-3 agonist Poly-ICLC has been known to activate immune cells and induce HIV replication in pre-clinical experiments. In this study we investigated if Poly-ICLC could be used for disrupting HIV latency while simultaneously enhancing innate immune responses.  Design:  This was a randomized, placebo-controlled, double-blinded trial in aviremic, cART-treated HIV-infected subjects. Participants ( n  = 15) were randomized 3:1 to receive two consecutive daily doses of Poly-ICLC (1.4 mg subcutaneously) vs. placebo. Subjects were observed for adverse events, immune activation, and viral replication.  Methods:  Besides primary outcomes of safety and tolerability, several longitudinal immune parameters were evaluated including immune cell phenotype and function via flowcytometry, ELISA, and transcriptional profiling. PCR assays for plasma HIV-1 RNA, CD4 +  T cell-associated HIV-1 RNA, and proviral DNA were performed to measure HIV reservoirs and latency.  Results:  Poly-ICLC was overall safe and well-tolerated. Poly-ICLC-related adverse events were Grade 1/2, with the exception of one Grade 3 neutropenia which was short-lived. Mild Injection site reactions were observed in nearly all participants in the Poly-ICLC arm. Transcriptional analyses revealed upregulation of innate immune pathways in PBMCs following Poly-ICLC treatment, including strong interferon signaling accompanied by transient increases in circulating IP-10 (CXCL10) levels. These responses generally peaked by 24-48 h after the first injection and returned to baseline by day 8. CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  Conclusions:  These finding suggest that Poly-ICLC could be safely used for inducing transient innate immune responses in treated HIV +  subjects indicating promise as an adjuvant for HIV therapeutic vaccines.  Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02071095.",2019,"CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  ","['aviremic, cART-treated HIV-infected subjects', 'Participants ( n  = 15', 'Patients With Treated HIV-Infection']","['Poly-ICLC', 'Placebo', 'placebo', 'Toll-like receptor-3 agonist Poly-ICLC']","['immune cell phenotype and function via flowcytometry, ELISA, and transcriptional profiling', 'safety and tolerability, several longitudinal immune parameters', 'PCR assays for plasma HIV-1 RNA, CD4 +  T cell-associated HIV-1 RNA, and proviral DNA', 'overall safe and well-tolerated', 'adverse events, immune activation, and viral replication', 'plasma viral control', 'HIV reservoirs', 'Mild Injection site reactions', 'circulating IP-10 (CXCL10) levels', 'CD4 +  T cell number and phenotype']","[{'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0071359', 'cui_str': 'polyriboinosinic-polyribocytidylic acid-polylysine carboxymethylcellulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1534866', 'cui_str': 'Toll-Like Receptor 3'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]",15.0,0.519423,"CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.  ","[{'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Sabado', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'La Mar', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mohri', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Salazar', 'Affiliation': 'Oncovir, Inc., Washington, DC, United States.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Correa Da Rosa', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Markowitz', 'Affiliation': 'Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY, United States.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00725']
272,31350585,Recovery and prognostic value of myocardial strain in ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion.,"OBJECTIVES


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


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


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


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


• In STEMI patients with a concurrent CTO, strain significantly improves over time, regardless of CTO-PCI. • Global strain is an independent predictor for functional recovery, incremental to infarct size, LVEF, and clinical parameters. • Segmental strain was able to predict the recovery of wall thickening, incremental to transmural extent of infarction.",2020,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"['ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion', '200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR', 'ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO']",['featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain'],"['Global strain', 'Global circumferential strain (GCS) and segmental strain', 'global LV function', 'Global longitudinal strain (GLS', 'LV ejection fraction']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",302.0,0.0840994,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"[{'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.elias@amsterdamumc.nl.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Loes P', 'Initials': 'LP', 'LastName': 'Hoebers', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Dagmar M', 'Initials': 'DM', 'LastName': 'Ouweneel', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': 'North Estonia Medical Center, Tallinn, Estonia.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ioanes', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'University Medical Center St Radboud, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06338-x']
273,32115419,Treatment Outcomes of Endovascular Embolization Only in Patients with Unruptured Brain Arteriovenous Malformations: A Subgroup Analysis of ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).,"BACKGROUND AND PURPOSE


Endovascular embolization only has been advocated for treatment of brain arteriovenous malformations in recent trials. Our aim was to evaluate the results of embolization only in a cohort of patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries.
MATERIALS AND METHODS


We analyzed the rates and severity of stroke and death in patients who underwent embolization only. Events were identified through in-person neurologic follow-up visits performed at 6-month intervals during the first 2 years and annually, with telephone contact every 6 months thereafter. All event-related data were reviewed by independent adjudicators.
RESULTS


Among 30 patients who had embolization planned, 26 underwent embolization only. A total of 13 stroke events were reported in the follow-up period among 26 subjects (ischemic, hemorrhagic, or both in 4, 7, and 2 subjects, respectively). The adverse event occurred after the first embolization in 11 of 13 patients. One patient had a major motor deficit, and 2 patients developed major visual field deficits. One event was fatal. The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors. Estimated stroke-free survival was 46% at 12 months.
CONCLUSIONS


Although the rates of stroke and/or death were high in patients treated with embolization only in ARUBA, the rates of favorable outcomes following stroke were high during follow-up.",2020,The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors.,"['patients who underwent embolization only', 'patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries', 'Patients with Unruptured Brain Arteriovenous Malformations', '30 patients who had embolization planned, 26 underwent embolization only']",['Endovascular Embolization'],"['Estimated stroke-free survival', 'major visual field deficits', 'rates and severity of stroke and death', 'adverse event', 'rates of stroke and/or death', 'modified Rankin Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0493133,The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors.,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota qureshai@gmail.com.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sahito', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liaqat', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': 'Division of Neurological Surgery (F.S.), University of Missouri, Colombia, Missouri.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology (A.I.Q., C.R.G.) and.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6443']
274,32247517,A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households.,"OBJECTIVE


To prospectively examine the bidirectional relationship between parental feeding practices (eg, instrumental feeding, encouragement to eat) and child eating behaviors (eg, food responsiveness, emotional eating) in low-income, ethnically diverse preschool children over a 3-year period.
STUDY DESIGN


Parent/child (age 2-4 years at baseline) pairs (n = 222 non-Hispanics; n = 312 Hispanics) participated in NET-Works (Now Everybody Together for Amazing and Healthful Kids), a randomized controlled trial carried out in community and in-home settings in urban areas of Minnesota. Data were collected at baseline and 12, 24, and 36 months. The present study is a secondary data analysis using cross-lagged models to identify bidirectional associations between parental feeding practices and child eating behaviors.
RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety. Model 1 showed significant bidirectional temporal paths, whereas models 2 and 3 showed significant unidirectional temporal paths from parental feeding practices to child eating behaviors.
CONCLUSIONS


Parental instrumental and emotional feeding practices prospectively influence child food responsiveness and satiety. This study demonstrates causal temporality between parental feeding practices and child eating behaviors. Heath care providers may want to use findings regarding parent feeding practices as part of their anticipatory guidance during well-child visits with parents of preschoolers.",2020,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","['Parent/child (age 2-4\xa0years at baseline) pairs (n\xa0=\xa0222 non-Hispanics; n\xa0=\xa0312 Hispanics) participated in', 'low-income, ethnically diverse preschool children over a 3-year period', 'Parent/Child Dyads from Low-Income and Minority Households', 'parental feeding practices and child eating behaviors', 'community and in-home settings in urban areas of Minnesota']",['NET-Works '],"['parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety', 'child eating behaviors (eg, food responsiveness, emotional eating']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0322418,"RESULTS


Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","[{'ForeName': 'Jerica M', 'Initials': 'JM', 'LastName': 'Berge', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN. Electronic address: jberge@umn.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Veblen-Mortenson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kunin-Batson', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.001']
275,31385047,No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"OBJECTIVE


To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.
METHODS


Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.
RESULTS


A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3).
CONCLUSION


In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.
KEY POINTS


• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.",2020,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"['A total of 120 patients were included', 'Exclusion criteria were as follows: primary tumors existing more than 3\xa0months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50', 'percutaneous palliation of malignant hilar biliary obstruction', 'Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed']","['adjuvant chemotherapy', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents', 'endoscopic intervention']","['Median survival', 'Safety, clinical success, and adjuvant chemotherapy', 'Occlusion rate', 'occlusion rate, patency, and survival', 'clinical success', 'Serious adverse events', 'Median patency', '30-day mortality', 'safety, clinical success, adjuvant chemotherapy, patency, or survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",120.0,0.277257,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-019-06374-7']
276,32149693,Estimating Fugl-Meyer Upper Extremity Motor Score From Functional-Connectivity Measures.,"Fugl-Meyer assessment is an accepted method of evaluating motor function for people with stroke. A challenge associated with this assessment is the availability of trained examiners to carry out the evaluation. Neurophysiological biomarkers show promise in addressing the above impediment. Our study investigated the potential of using resting state electroencephalographic (EEG) functional connectivity measures as biomarkers for estimating Fugl-Meyer upper extremity motor score (FMU) in people with chronic stroke. Resting state EEG was recorded from 10 individuals with stroke. Functional connectivity was evaluated through five different processing algorithms and quantified in terms of maximum-coherence between EEG electrodes at 15 frequencies from 1 to 45 Hz. We applied a multi-variate Partial Least Squares (PLS) Correlation analysis to simultaneously identify specific connectivity channels (EEG electrode pairings) and frequencies that robustly correlated with FMU. We then applied PLS-Regression to the identified channels and frequencies to generate a set of coefficients for estimating the FMU. Participants were randomly assigned to a training-set of eight and a test-set of two. Cross-validation with leave-one-out approach on the training-set, using Phase-Lag-Index processing algorithm, resulted in an R 2  of 0.97 and a least-square linear fit slope of 1 for predicted versus actual FMU, with a root-mean-square error of 1.9 on FMU scale. Application of regression coefficients to the connectivity measures from the test-set resulted in predicted FMU of 47 and 38 versus actual scores of 46 and 39, respectively. Our results demonstrated that the evaluation of neural correlates of FMU shows promise in addressing the challenges associated with the availability of trained examiners to carry out the assessments.",2020,Correlation analysis to simultaneously identify specific connectivity channels (EEG electrode pairings) and frequencies that robustly correlated with FMU.,"['people with chronic stroke', '10 individuals with stroke', 'people with stroke']","['multi-variate Partial Least Squares (PLS', 'resting state electroencephalographic (EEG) functional connectivity measures']",['Functional connectivity'],"[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0220883,Correlation analysis to simultaneously identify specific connectivity channels (EEG electrode pairings) and frequencies that robustly correlated with FMU.,"[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Riahi', 'Affiliation': ''}, {'ForeName': 'Vasily A', 'Initials': 'VA', 'LastName': 'Vakorin', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Menon', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2978381']
277,32282691,Infraorbital Foramen Decompression Surgery for the Infraorbital Nerve Hypoesthesia in Patients With Isolated Fracture of Maxillary Sinus Anterior Wall.,"Isolated fracture of maxillary sinus anterior wall is relatively uncommon. If the extent of fracture is minimal, only conservative care is amenable, however, there is no agreement on whether infraorbital nerve dysfunction can be used as an indication for surgical intervention. This study was conducted to verify the effect of decompression surgery of infraorbital foramen for recovery of hypoesthesia. A total of 26 patients with unilateral fracture of maxillary sinus anterior wall were enrolled. Ten who received only conservative therapy were allocated in the control group, while sixteen patients were assigned to the decompression group. Pre- and post-treatment sensory assessment using visual analogue scale (VAS) was recorded. Overall treatment satisfaction was also evaluated by means of global assessment scale (GAS). Both absolute VAS value and score increment showed statistical difference only at 4 weeks (P = 0.010 and P = 0.021, respectively), but no significant difference at 1, 12, and 24 weeks. GAS score also showed no statistical significance (P = 0.386). Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall. Therefore, it is not recommended to perform the operation when the infraorbital nerve hypoesthesia is the only indication for the open reduction.",2020,Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall.,"['Patients With Isolated Fracture of Maxillary Sinus Anterior Wall', '26 patients with unilateral fracture of maxillary sinus anterior wall were enrolled']","['conservative therapy', 'Infraorbital Foramen Decompression Surgery', 'decompression surgery of infraorbital foramen']","['global assessment scale (GAS', 'hypoesthesia recovery', 'GAS score', 'Overall treatment satisfaction', 'visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0929085', 'cui_str': 'Infraorbital foramen'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",26.0,0.014145,Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall.,"[{'ForeName': 'Jongweon', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.""}, {'ForeName': 'Ee Room', 'Initials': 'ER', 'LastName': 'Jung', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu.""}, {'ForeName': 'Jin Tae', 'Initials': 'JT', 'LastName': 'Cho', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu.""}, {'ForeName': 'Gyeol', 'Initials': 'G', 'LastName': 'Yoo', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006455']
278,31499231,Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS.,"OBJECTIVE


Adults with irritable bowel syndrome (IBS) often report extraintestinal pain, fatigue, and sleep disturbances in addition to abdominal pain. Few interventions have sought to reduce these extraintestinal symptoms within the IBS population. To address this, we compared the effects of a comprehensive self-management (CSM) intervention to a control intervention (usual care) on extraintestinal pain, fatigue, and sleep disturbances among patients with IBS.
METHOD


Data were obtained from 243 IBS patients participating in two CSM intervention trials. Daily symptom diaries were collected at baseline, 3 and 6 months post-randomization. Daily symptoms of headache, backache, muscle pain, joint pain, fatigue, sleepiness during the day, sleep quality, and refreshed by sleep were analyzed. Analysis of covariance was used to determine the effects of the intervention on each symptom at 3 and 6 months controlling for 'study' and baseline symptom levels.
RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months. The CSM group also reported significantly decreased joint pain at 3 months compared to usual care, but not 6 months. No significant difference was found for muscle pain.
CONCLUSIONS


An existing CSM intervention is effective in reducing fatigue and sleep disturbances. However, mixed results for extraintestinal pain indicates a need to better differentiate between underlying mechanisms. Addressing such symptoms is important to decrease the overall burden of IBS, reduce health care expenditures, and improve patients' quality of life.
TRIAL REGISTRATION


NCT00907790; NCT00167635.",2019,"RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months.","['patients with IBS', 'Adults with irritable bowel syndrome (IBS', '243 IBS patients participating in two CSM intervention trials']","['comprehensive self-management (CSM) intervention', 'comprehensive self-management intervention', 'control intervention (usual care', 'CSM intervention']","['Daily symptom diaries', 'joint pain', 'fatigue and sleep disturbances', 'extraintestinal pain, fatigue, and sleep disturbances', 'muscle pain', 'Daily symptoms of headache, backache, muscle pain, joint pain, fatigue, sleepiness during the day, sleep quality, and refreshed by sleep', 'extraintestinal symptoms', 'symptoms of fatigue, sleep disturbances, backache and headache']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",243.0,0.0367462,"RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months.","[{'ForeName': 'Kendra J', 'Initials': 'KJ', 'LastName': 'Kamp', 'Affiliation': 'University of Washington, United States of America. Electronic address: kamp@uw.edu.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Weaver', 'Affiliation': 'University of Maryland, United States of America. Electronic address: kristen.weaver@umaryland.edu.'}, {'ForeName': 'LeeAnne B', 'Initials': 'LB', 'LastName': 'Sherwin', 'Affiliation': 'University of Missouri, United States of America. Electronic address: sherwinl@missouri.edu.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Barney', 'Affiliation': 'University of Washington, United States of America. Electronic address: pamb@uw.edu.'}, {'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Hwang', 'Affiliation': 'Pusan National University, South Korea. Electronic address: skhwang@uw.edu.'}, {'ForeName': 'Pei-Lin', 'Initials': 'PL', 'LastName': 'Yang', 'Affiliation': 'University of Washington, United States of America. Electronic address: plinyang@uw.edu.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Burr', 'Affiliation': 'University of Washington, United States of America. Electronic address: bobburr@uw.edu.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Cain', 'Affiliation': 'University of Washington, United States of America. Electronic address: cain@uw.edu.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Heitkemper', 'Affiliation': 'University of Washington, United States of America. Electronic address: heit@uw.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109821']
279,31509614,"Greater mindfulness associated with lower pain, fatigue, and psychological distress in women with metastatic breast cancer.","OBJECTIVE


Women with metastatic breast cancer (MBC) report high levels of disease-related symptoms including pain, fatigue, psychological distress, and sleep disturbance. Mindfulness may be particularly relevant to women with MBC given the high symptom burden and psychological toll of this disease; however, the topic is understudied among this patient population. Therefore, we aimed to test the associations between mindfulness and patient-reported symptoms among a sample of women with MBC.
METHODS


Sixty-four women with MBC completed baseline questionnaires of mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF]) and symptoms of pain severity and interference, fatigue, psychological distress, and sleep disturbance as part of a randomized controlled trial of a Mindful Yoga intervention. Correlational analyses of data collected at baseline tested associations between the five mindfulness facets (observing, describing, acting with awareness, nonjudging, and nonreactivity) and patient-reported measures of symptoms.
RESULTS


Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance. However, degree of association varied by mindfulness facet. Nonreactivity, nonjudging, and describing showed the most frequent associations and largest effect sizes across symptoms, while observing showed the least frequent associations and lowest effect sizes.
CONCLUSIONS


Mindfulness-and in particular nonreactivity, nonjudging, and describing-may be a personal resource for women with MBC in coping with complex symptoms of this life-threatening illness. Findings are discussed relative to their implications for interventions aimed at increasing mindfulness in this vulnerable population.",2020,"Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance.","['women with MBC', 'Women with metastatic breast cancer (MBC', '64 women with MBC completed', 'Women with Metastatic Breast Cancer']",['Mindful Yoga intervention'],"['baseline questionnaires of mindfulness (FFMQ-SF) and symptoms of pain severity and interference, fatigue, psychological distress, and sleep disturbance', 'pain, fatigue, psychological distress, and sleep disturbance', 'pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance', 'Lower Pain, Fatigue, and Psychological Distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",64.0,0.0543269,"Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Zimmaro', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health and Sciences University, Oregon, Portland.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, North Carolina.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}]",Psycho-oncology,['10.1002/pon.5223']
280,30455077,Treatment with allogeneic mesenchymal stromal cells for moderate to severe acute respiratory distress syndrome (START study): a randomised phase 2a safety trial.,"BACKGROUND


Treatment with bone-marrow-derived mesenchymal stromal cells (MSCs) has shown benefits in preclinical models of acute respiratory distress syndrome (ARDS). Safety has not been established for administration of MSCs in critically ill patients with ARDS. We did a phase 2a trial to assess safety after administration of MSCs to patients with moderate to severe ARDS.
METHODS


We did a prospective, double-blind, multicentre, randomised trial to assess treatment with one intravenous dose of MSCs compared with placebo. We recruited ventilated patients with moderate to severe ARDS (ratio of partial pressure of oxygen to fractional inspired oxygen <27 kPa and positive end-expiratory pressure [PEEP] ≥8 cm H 2 O) in five university medical centres in the USA. Patients were randomly assigned 2:1 to receive either 10 × 10 6 /kg predicted bodyweight MSCs or placebo, according to a computer-generated schedule with a variable block design and stratified by site. We excluded patients younger than 18 years, those with trauma or moderate to severe liver disease, and those who had received cancer treatment in the previous 2 years. The primary endpoint was safety and all analyses were done by intention to treat. We also measured biomarkers in plasma. MSC viability was tested in a post-hoc analysis. This trial is registered with ClinicalTrials.gov, number NCT02097641.
FINDINGS


From March 24, 2014, to Feb 9, 2017 we screened 1038 patients, of whom 60 were eligible for and received treatment. No patient experienced any of the predefined MSC-related haemodynamic or respiratory adverse events. One patient in the MSC group died within 24 h of MSC infusion, but death was judged to be probably unrelated. 28-day mortality did not differ between the groups (30% in the MSC group vs 15% in the placebo group, odds ratio 2·4, 95% CI 0·5-15·1). At baseline, the MSC group had numerically higher mean scores than the placebo group for Acute Physiology and Chronic Health Evaluation III (APACHE III; 104 [SD 31] vs 89 [33]), minute ventilation (11·1 [3·2] vs 9·6 [2·4] L/min), and PEEP (12·4 [3·7] vs 10·8 [2·6] cm H 2 O). After adjustment for APACHE III score, the hazard ratio for mortality at 28 days was 1·43 (95% CI 0·40-5·12, p=0·58). Viability of MSCs ranged from 36% to 85%.
INTERPRETATION


One dose of intravenous MSCs was safe in patients with moderate to severe ARDS. Larger trials are needed to assess efficacy, and the viability of MSCs must be improved.
FUNDING


National Heart, Lung, and Blood Institute.",2019,"28-day mortality did not differ between the groups (30% in the MSC group vs 15% in the placebo group, odds ratio 2·4, 95% CI 0·5-15·1).","['five university medical centres in the USA', 'patients younger than 18 years, those with trauma or moderate to severe liver disease, and those who had received cancer treatment in the previous 2 years', '1038 patients, of whom 60 were eligible for and received treatment', 'ventilated patients with moderate to severe ARDS (ratio of partial pressure of oxygen to fractional inspired oxygen <27 kPa and positive end-expiratory pressure [PEEP', '2·6', 'moderate to severe acute respiratory distress syndrome (START study', 'patients with moderate to severe ARDS', 'critically ill patients with ARDS', 'From March 24, 2014, to Feb 9, 2017']","['allogeneic mesenchymal stromal cells', 'placebo', 'MSCs', 'bone-marrow-derived mesenchymal stromal cells (MSCs', '10 × 10 6 /kg predicted bodyweight MSCs or placebo', 'intravenous MSCs', 'MSC']","['Viability of MSCs', 'Acute Physiology and Chronic Health Evaluation III', 'hazard ratio for mortality', 'haemodynamic or respiratory adverse events', 'minute ventilation', '28-day mortality', 'MSC viability']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0450980', 'cui_str': 'Acute physiology and chronic health evaluation III (assessment scale)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.750223,"28-day mortality did not differ between the groups (30% in the MSC group vs 15% in the placebo group, odds ratio 2·4, 95% CI 0·5-15·1).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA. Electronic address: michael.matthay@ucsf.edu.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'Department of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hanjing', 'Initials': 'H', 'LastName': 'Zhuo', 'Affiliation': 'Cardiovascular Research Institute, University of California, San Francisco, CA, USA.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Wilson', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Gotts', 'Affiliation': 'Department of Medicine and Anesthesia, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeanine P', 'Initials': 'JP', 'LastName': 'Wiener-Kronish', 'Affiliation': 'Department of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ednan K', 'Initials': 'EK', 'LastName': 'Bajwa', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Donahoe', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McVerry', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Ortiz', 'Affiliation': 'Department of Environmental and Occupational Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Exline', 'Affiliation': 'Department of Medicine, Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Christman', 'Affiliation': 'Department of Medicine, Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Abbott', 'Affiliation': 'Cardiovascular Research Institute, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lizette', 'Initials': 'L', 'LastName': 'Caballero', 'Affiliation': 'Bone and Marrow Transplant Laboratory, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'McMillan', 'Affiliation': 'Bone and Marrow Transplant Laboratory, University of California, San Francisco, CA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'McKenna', 'Affiliation': 'University of Minnesota, Molecular and Cellular Therapeutics, Saint Paul, MN, USA.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(18)30418-1']
281,31273283,Modafinil treatment modulates functional connectivity in stroke survivors with severe fatigue.,"Post-stroke fatigue has a significant impact on stroke survivors' mental and physical well-being. Our recent clinical trial showed significant reduction of post-stroke fatigue with modafinil treatment, however functional connectivity changes in response to modafinil have not yet been explored in stroke survivors with post-stroke fatigue. Twenty-eight participants (multidimensional fatigue inventory-20 ≥ 60) had MRI scans at baseline, and during modafinil and placebo treatment. Resting-state functional MRI data were obtained, and independent component analysis was used to extract functional networks. Resting-state functional connectivity (rsFC) was examined between baseline, modafinil and placebo treatment using permutation testing with threshold-free cluster enhancement. Overall twenty-eight participants (mean age: 62 ± 14.3, mean baseline MFI-20: 72.3 ± 9.24) were included. During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo. This coincided with lower rsFC in the left frontoparietal (inferior parietal lobule, p = 0.023, 13 voxels), somatosensory (primary somatosensory cortex; p = 0.009, 32 voxels) and mesolimbic network (temporal pole, p = 0.016, 35 voxels). In conclusion, modafinil treatment induces significant changes in rsFC in post-stroke fatigue. This modulation of rsFC may relate to a reduction of post-stroke fatigue; however, the relationship between sensory processing, neurotransmitter expression and fatigue requires further exploration.",2019,"During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo.","['stroke survivors with severe fatigue', 'Overall twenty-eight participants (mean age: 62\u2009±\u200914.3, mean baseline MFI-20: 72.3\u2009±\u20099.24) were included', 'Twenty-eight participants (multidimensional fatigue inventory-20']","['modafinil and placebo', 'modafinil', 'placebo', 'Modafinil']","['MRI scans', 'rsFC', 'functional connectivity', 'Resting-state functional connectivity (rsFC']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.122712,"During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo.","[{'ForeName': 'Milanka M', 'Initials': 'MM', 'LastName': 'Visser', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, 2308, New South Wales, Australia. milanka.visser@unimelb.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Goodin', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lillicrap', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}]",Scientific reports,['10.1038/s41598-019-46149-0']
282,32277824,Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study.,"OBJECTIVE


To evaluate upadacitinib efficacy and safety dose response in Japanese patients with active RA and an inadequate response to conventional synthetic DMARDs (csDMARDs).
METHODS


This was a multicentre, phase IIb/III, dose-ranging study conducted in Japan, in which patients on previously stable csDMARDs were randomized to receive upadacitinib 7.5, 15 or 30 mg once daily or matching placebo for a 12-week double-blind period. The primary endpoint was a 20% improvement in ACR criteria (ACR20) response at week 12 using non-responder imputation. Key secondary endpoints included ACR50, ACR70 and 28-joint DAS with CRP (DAS28-CRP) remission and low disease activity. Adverse events were also assessed.
RESULTS


Of 197 patients treated, 187 completed the double-blind period. At week 12, more patients receiving upadacitinib 7.5, 15 or 30 mg vs placebo met the ACR20 response (75.5%, 83.7%, 80.0% vs 42.9%; P < 0.001), with significant differences observed as early as week 1. Stringent responses, including ACR50, ACR70 and DAS28-CRP <2.6, were achieved by significantly higher proportions of patients on upadacitinib than placebo and by numerically higher proportions on upadacitinib 15 or 30 mg vs upadacitinib 7.5 mg. Adverse events and infections (serious infections, opportunistic infections and herpes zoster) were more common with upadacitinib vs placebo and numerically highest with upadacitinib 30 mg. There were no venous thromboembolic events reported.
CONCLUSION


Efficacy of upadacitinib was demonstrated in this population of Japanese patients with RA and an inadequate response to csDMARDs. Safety and tolerability were consistent with other upadacitinib RA studies. The 15 mg dose of upadacitinib showed the most favourable benefit-risk profile.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02720523.",2020,"Adverse events and infections (serious infections, opportunistic infections and herpes zoster) were more common with upadacitinib vs placebo and numerically highest with upadacitinib 30 mg.","['Japan, in which patients on previously stable csDMARDs', 'Japanese patients with rheumatoid arthritis (SELECT-SUNRISE', 'Japanese patients with active RA and an inadequate response to conventional synthetic DMARDs (csDMARDs', 'Japanese patients with RA', '197 patients treated']","['upadacitinib 7.5, 15 or 30\u2009mg once daily or matching placebo', 'upadacitinib', 'placebo']","['Adverse events', 'venous thromboembolic events', 'ACR criteria (ACR20) response', 'ACR20 response', 'Efficacy and safety', 'Adverse events and infections (serious infections, opportunistic infections and herpes zoster', 'Safety and tolerability', 'ACR50, ACR70 and 28-joint DAS with CRP (DAS28-CRP) remission and low disease activity']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",197.0,0.293985,"Adverse events and infections (serious infections, opportunistic infections and herpes zoster) were more common with upadacitinib vs placebo and numerically highest with upadacitinib 30 mg.","[{'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Internal Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Oribe', 'Affiliation': 'Department of Internal Medicine, Oribe Clinic of Rheumatism and Medicine, Oita, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kawano', 'Affiliation': 'Rheumatology, Honjo Rheumatism Clinic, Japan, Takaoka.'}, {'ForeName': 'Yijie', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Immunology, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Immunology, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'Immunology, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Kitamura', 'Affiliation': 'Immunology, AbbVie GK, Japan, Tokyo.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Meerwein', 'Affiliation': 'Pharmaceutical Development, AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa084']
283,32078436,Cocoa to Improve Walking Performance in Older People With Peripheral Artery Disease: The COCOA-PAD Pilot Randomized Clinical Trial.,"RATIONALE


Cocoa and its major flavanol component, epicatechin, have therapeutic properties that may improve limb perfusion and increase calf muscle mitochondrial activity in people with lower extremity peripheral artery disease (PAD).
OBJECTIVE


In a phase II randomized clinical trial, to assess whether 6 months of cocoa improved walking performance in people with PAD, compared with placebo.
METHODS AND RESULTS


Six-month double-blind, randomized clinical trial in which participants with PAD were randomized to either cocoa beverage versus placebo beverage. The cocoa beverage contained 15 g of cocoa and 75 mg of epicatechin daily. The identical appearing placebo contained neither cocoa nor epicatechin. The 2 primary outcomes were 6-month change in 6-minute walk distance measured 2.5 hours after a study beverage at 6-month follow-up and 24 hours after a study beverage at 6-month follow-up, respectively. A 1-sided  P <0.10 was considered statistically significant. Of 44 PAD participants randomized (mean age, 72.3 years [±7.1]; mean ankle brachial index, 0.66 [±0.15]), 40 (91%) completed follow-up. Adjusting for smoking, race, and body mass index, cocoa improved 6-minute walk distance at 6-month follow-up by 42.6 m ([90% CI, +22.2 to +∞]  P =0.005) at 2.5 hours after a final study beverage and by 18.0 m ([90% CI, -1.7 to +∞]  P =0.12) at 24 hours after a study beverage, compared with placebo. In calf muscle biopsies, cocoa improved mitochondrial COX (cytochrome c oxidase) activity ( P =0.013), increased capillary density ( P =0.014), improved calf muscle perfusion ( P =0.098), and reduced central nuclei ( P =0.033), compared with placebo.
CONCLUSIONS


These preliminary results suggest a therapeutic effect of cocoa on walking performance in people with PAD. Further study is needed to definitively determine whether cocoa significantly improves walking performance in people with PAD.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02876887. Visual Overview: An online visual overview is available for this article.",2020,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","['people with lower extremity peripheral artery disease (PAD', 'Older People With Peripheral Artery Disease', '44 PAD participants randomized (mean age: 72.3 years (+7.1), mean ankle brachial index 0.66 (+0.15)), 40 (91%) completed follow-up', 'participants with PAD', 'people with PAD']","['placebo', 'cocoa beverage vs. placebo beverage', 'cocoa nor epicatechin', 'cocoa', 'Cocoa']","['mitochondrial cytochrome c oxidase activity', 'Walking Performance', 'calf muscle perfusion', 'six-month change in six-minute walk distance', 'walking performance', 'capillary density', 'reduced central nuclei']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0014485', 'cui_str': '(2R,3R)-2-(3,4-Dihydroxyphenyl)-3,5,7-chromanetriol'}]","[{'cui': 'C0010760', 'cui_str': 'Electron Transport Complex IV'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007763', 'cui_str': 'Central Nuclei'}]",,0.668891,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'Department of Family Medicine, University of California at San Diego (M.H.C.).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'Division of Intramural Research, National Institute on Aging, Baltimore, MD (L.F.).'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore (J.M.G.).'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'Department of Surgery, University of North Carolina School of Medicine, Chapel Hill (M.R.K.).'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kosmac', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kramer', 'Affiliation': 'Department of Radiology and Medical Imaging, University of Virginia Health System, Charlottesville (C.M.K.).'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville (C.L.).'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Lloyd-Jones', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Tamar S', 'Initials': 'TS', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of Chicago, IL (T.S.P.).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison (J.H.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Neurology (R.S.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'Divisions of Cardiology (F.V.), University of San Diego, CA.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Health Research and Policy, Stanford University, CA (L.T.).'}]",Circulation research,['10.1161/CIRCRESAHA.119.315600']
284,30359616,Rapidly Improving ARDS in Therapeutic Randomized Controlled Trials.,"BACKGROUND


Observational studies suggest that some patients meeting criteria for ARDS no longer fulfill the oxygenation criterion early in the course of their illness. This subphenotype of rapidly improving ARDS has not been well characterized. We attempted to assess the prevalence, characteristics, and outcomes of rapidly improving ARDS and to identify which variables are useful to predict it.
METHODS


A secondary analysis was performed of patient level data from six ARDS Network randomized controlled trials. We defined rapidly improving ARDS, contrasted with ARDS > 1 day, as extubation or a Pao 2  to Fio 2  ratio (Pao 2 :Fio 2 ) > 300 on the first study day following enrollment.
RESULTS


The prevalence of rapidly improving ARDS was 10.5% (458 of 4,361 patients) and increased over time. Of the 1,909 patients enrolled in the three most recently published trials, 197 (10.3%) were extubated on the first study day, and 265 (13.9%) in total had rapidly improving ARDS. Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > 1 day. Pao 2 :Fio 2  at screening, change in Pao 2 :Fio 2  from screening to enrollment, use of vasopressor agents, Fio 2  at enrollment, and serum bilirubin levels were useful predictive variables.
CONCLUSIONS


Rapidly improving ARDS, mostly defined by early extubation, is an increasingly prevalent and distinct subphenotype, associated with better outcomes than ARDS > 1 day. Enrollment of patients with rapidly improving ARDS may negatively affect the prognostic enrichment and contribute to the failure of therapeutic trials.",2019,Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > ,"['1,909 patients enrolled in the three most recently published trials, 197 (10.3%) were extubated on the first study day, and 265 (13.9%) in total had rapidly improving ARDS', 'Pao 2 ']",['ARDS'],"['60-day mortality', 'prevalence of rapidly improving ARDS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]",4361.0,0.310413,Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > ,"[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Schenck', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Oromendia', 'Affiliation': 'Department of Healthcare Policy and Research, Division of Biostatistics and Epidemiology, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Torres', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berlin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M K', 'Initials': 'AMK', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Ilias I', 'Initials': 'II', 'LastName': 'Siempos', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY; First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, University of Athens Medical School, Athens, Greece. Electronic address: isiempos@yahoo.com.'}]",Chest,['10.1016/j.chest.2018.09.031']
285,32277749,"Gospel Music: A Catalyst for Retention, Engagement, and Positive Health Outcomes for African Americans in a Cardiovascular Prevention and Treatment Program.","Context


Mortality associated with cardiovascular disease is significantly higher in African Americans compared with people of other ethnicities, with hypertension being the single most significant risk factor in this population. Underdiagnosis and undertreatment of hypertension is common. Although cardiovascular lifestyle education and self-management programs are available for the general public, many African Americans prefer to learn about health-promoting activities through interactive programs led by church ministries.
Objective


This study examined the influence of adding a faith-based protocol using creative musical expression as a catalyst for improving retention, engagement, and positive health outcomes for African Americans participating in a 1-y, lifestyle skills program for reducing cardiovascular risk factors.
Design


The study was a randomized, controlled trial.
Setting


The study occurred at Rodman Street Missionary Baptist Church (Pittsburgh, PA, USA).
Participants


Participants were African Americans with at least 2 of the following medical conditions: high blood pressure, elevated cholesterol and/or triglycerides, heart attack, angina, stroke, irregular heartbeats, palpitations, shortness of breath, dizziness or fainting, diabetes, and tobacco use.
Intervention


Intervention and control groups both participated every other week in one 45-min structured cardiovascular risk reduction educational session over the course of 1 year. During alternative weeks, sessions comprised blood pressure checks, coupled with individualized support discussions focused on challenges and identified obstacles to adherence. In addition to the aforementioned sessions, the intervention group participated in a novel gospel music program with weekly, 45-minute vocal and instrumental sessions.
Outcome Measures


Outcome measures include retention, attendance, systolic and diastolic blood pressures, weight, body mass index, hip measurement, and waist measurement as well as the Short Form-12 (SH-12) Health Survey.
Results


Subjects in the intervention group demonstrated a statistically significant 83.3% retention rate in the course of 1 year compared with only 54.3% for the control group (cardiovascular lifestyle education sessions alone). Six dropouts were noted in the intervention group in sharp contrast to 16 dropouts in the control group. Participants in the intervention group were 4.21 times more likely to complete the program than the control group. A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group). Statistically significant systolic blood pressure reductions noted in both groups were sustained 6 mo postprogram conclusion. In addition, a statistically significant pre-between post-between group improvement in SF-12 Physical Component Scores was noted for intervention subjects in sharp contrast with controls who actually demonstrated worsening scores.
Conclusions


The addition of a gospel music program as a catalyst for increase engagement in a sustainable, healthy lifestyle program warrants further consideration and additional study in African American churches.",2020,"A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group).","['African American churches', 'African Americans', 'African Americans participating in a 1-y', 'Participants\n\n\nParticipants were African Americans with at least 2 of the following medical conditions: high blood pressure, elevated cholesterol and/or triglycerides, heart attack, angina, stroke, irregular heartbeats, palpitations, shortness of breath, dizziness or fainting, diabetes, and tobacco use']","['faith-based protocol using creative musical expression', 'lifestyle skills program', 'Intervention\n\n\nIntervention and control groups both participated every other week in one 45-min structured cardiovascular risk reduction educational session', 'Gospel Music', 'novel gospel music program with weekly, 45-minute vocal and instrumental sessions']","['retention, engagement, and positive health outcomes', 'SF-12 Physical Component Scores', 'retention rate', 'systolic blood pressure reductions', 'retention, attendance, systolic and diastolic blood pressures, weight, body mass index, hip measurement, and waist measurement as well as the Short Form-12 (SH-12) Health Survey']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",6.0,0.0431136,"A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group).","[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Bittman', 'Affiliation': ''}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Poornima', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'R Eric', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': ''}]",Advances in mind-body medicine,[]
286,32276980,A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects.,"The human oral cavity is a complex ecosystem, and the alterations in salivary microbial communities are associated with both oral and nonoral diseases. The Mediterranean diet (MD) is a healthy dietary pattern useful for both prevention and treatment of several diseases. To further explore the effects of the MD on human health, in this study, we investigated the changes in the salivary microbial communities in overweight/obese subjects after an individually tailored MD-based nutritional intervention. Healthy overweight and obese subjects were randomized between two intervention groups. The MD group (Med-D group) increased their MD adherence during 8 weeks of intervention while the control diet (control-D) group did not change their dietary habits. The salivary microbiota was assessed at baseline and after 4 and 8 weeks of intervention. Despite no observed changes in the overall salivary microbiota composition, we found a significant decrease in the relative abundances of species-level operational taxonomic units annotated as  Porphyromonas gingivalis ,  Prevotella intermedia , and  Treponema denticola  in the Med-D group compared to that in the control-D group after 8 weeks of intervention, which are known to be associated with periodontal disease. Such variations were significantly linked to dietary variables such as MD adherence rates and intakes of animal versus vegetable proteins. In addition, increased levels of  Streptococcus cristatus  were observed in the Med-D group, which has been reported as an antagonistic taxon inhibiting  P. gingivalis  gene expression. Our findings suggest that an MD-based nutritional intervention may be implicated in reducing periodontal bacteria, and an MD may be a dietary strategy supportive of oral homeostasis. IMPORTANCE  Changes in dietary behavior with increased adherence to a Mediterranean diet can determine a reduction of periodontopathogenic bacterial abundances in the saliva of overweight subjects with cardiometabolic risk due to an unhealthy lifestyle, without any change in individual energy intake, nutrient intake, and physical activity.",2020,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"['overweight and obese subjects', 'Healthy overweight and obese subjects', 'overweight/obese subjects after an individually tailored MD-based nutritional intervention']","['Mediterranean diet intervention', 'Mediterranean diet (MD', 'MD']","['salivary microbiota', 'overall salivary microbiota composition', 'salivary periodontopathogenic bacteria', 'levels of  Streptococcus cristatus', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318141', 'cui_str': 'Streptococcus cristatus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0139182,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"[{'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it.'}]",Applied and environmental microbiology,['10.1128/AEM.00777-20']
287,30354023,Short- or Long-Term Treatment of Spinal Disability in Older Adults With Manipulation and Exercise.,"OBJECTIVE


Back and neck pain are associated with disability and loss of independence in older adults. Whether long-term management using commonly recommended treatments is superior to shorter-term treatment is unknown. This randomized clinical trial compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back- and neck-related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
METHODS


Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent-to-treat approach used linear mixed-model analysis to detect between-group differences. Secondary analyses included other self-reported outcomes, adverse events, and objective functional measures.
RESULTS


A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back disability (ODI score -3.9 [95% confidence interval (95% CI) -5.8, -2.0] versus ODI score -6.3 [95% CI -8.2, -4.4]) and neck disability (NDI score -7.3 [95% CI -9.1, -5.5] versus NDI score -9.0 [95% CI -10.8, -7.2]) after 36 weeks, with no difference between groups (back ODI score 2.4 [95% CI -0.3, 5.1]; neck NDI score 1.7 [95% CI 0.8, 4.2]). The long-term management group experienced greater improvement in neck pain at week 36, in self-efficacy at weeks 36 and 52, and in functional ability, and balance.
CONCLUSION


For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.",2019,"The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.
","['older adults using', 'older adults with chronic back and neck disability', 'Eligible participants were age 65 and older with back and neck disability for more than 12 weeks', 'older adults with manipulation and exercise', '182 participants were randomized', 'older adults']",['spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE'],"['disability', 'back', 'spinal disability', 'neck pain', 'functional ability and balance', 'changes in Oswestry and Neck Disability Index', 'self-reported outcomes, adverse events and objective functional measures', 'neck disability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0949742', 'cui_str': 'Manipulation Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",182.0,0.174488,"The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maiers', 'Affiliation': 'Northwestern Health Sciences University, Bloomington, Minnesota.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'University of Southern Denmark and Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Westrom', 'Affiliation': 'Northwestern Health Sciences University, Bloomington, Minnesota.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Leininger', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Bronfort', 'Affiliation': 'University of Minnesota, Minneapolis.'}]",Arthritis care & research,['10.1002/acr.23798']
288,32275467,"Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial.","PURPOSE


Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) includes a taxane and an anthracycline. Concomitant capecitabine may be beneficial, but robust data to support this are lacking. The efficacy and safety of the addition of capecitabine into the TNBC adjuvant treatment regimen was evaluated.
PATIENTS AND METHODS


This randomized, open-label, phase III trial was conducted in China. Eligible female patients with early TNBC after definitive surgery were randomly assigned (1:1) to either capecitabine (3 cycles of capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide). Randomization was centralized without stratification. The primary end point was disease-free survival (DFS).
RESULTS


Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585 were randomly assigned to treatment (control, 288; capecitabine, 297). Median follow-up was 67 months. The 5-year DFS rate was higher for capecitabine than for control treatment (86.3%  v  80.4%; hazard ratio, 0.66; 95% CI, 0.44 to 0.99;  P  = .044). Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%). Overall, 39.1% of patients had capecitabine dose reductions, and 8.4% reported grade ≥ 3 hand-foot syndrome. The most common grade ≥ 3 hematologic toxicities were neutropenia (capecitabine, 136 [45.8%]; control, 118 [41.0%]) and febrile neutropenia (capecitabine, 50 [16.8%]; control, 46 [16.0%]). Safety data were similar to the known capecitabine safety profile and generally comparable between arms.
CONCLUSION


Capecitabine when added to 3 cycles of docetaxel followed by 3 cycles of a 3-drug anthracycline combination containing capecitabine instead of fluorouracil significantly improved DFS in TNBC without new safety concerns.",2020,"Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%).","['Triple-Negative Breast Cancer', 'Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585', 'Eligible female patients with early TNBC after definitive surgery', 'triple-negative breast cancer (TNBC']","['taxane and an anthracycline', 'docetaxel', 'CBCSG010', 'fluorouracil', 'adjuvant chemotherapy', 'capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide', 'Capecitabine', 'capecitabine', 'Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin']","['disease-free survival (DFS', 'overall survival rates', 'febrile neutropenia', 'DFS', 'hematologic toxicities', '5-year DFS rate', 'efficacy and safety']","[{'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",636.0,0.0969312,"Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%).","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Keda', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': ""Department of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Changqin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Jilin Cancer Hospital and Institute, Changchun, Jilin, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Breast Surgery, Southwest Hospital, Chongqing, Chongqing, People's Republic of China.""}, {'ForeName': 'Suisheng', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Breast Surgery, Gansu Cancer Hospital, Lanzhou, Gansu, People's Republic of China.""}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': ""Department of Breast Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Sheng', 'Affiliation': ""Department of Breast Surgery, Changhai Hospital of Shanghai, Shanghai, People's Republic of China.""}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Cancer Hospital of Shantou Medical College, Shantou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Breast Surgery, The Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, The International Peace Maternity and Child Health Hospital of China Welfare Institute, Shanghai, People's Republic of China.""}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': ""Department of Breast Surgery, Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, People's Republic of China.""}, {'ForeName': 'Xijing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Medical College, The Second Affiliated Hospital of Xi'An Jiaotong University, Xi'an, Shanxi, People's Republic of China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': ""Department of Breast Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, People's Republic of China.""}, {'ForeName': 'Xinzheng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Breast Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, People's Republic of China.""}, {'ForeName': 'Shiyou', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Eastern Hospital of Suzhou Municipal Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Pengxi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': ""Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""Department of Breast Surgery, Jiangsu Cancer Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ouchen', 'Initials': 'O', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, The First Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Breast Surgery, The First Hospital of Jilin University, Changchun, Jilin, People's Republic of China.""}, {'ForeName': 'Guoqin', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': ""Department of General Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The General Hospital of the People's Liberation Army, Beijing, People's Republic of China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Jiangsu Province Hospital, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Breast Surgery, The First Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Nanyan', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': ""Department of Breast Surgery, The Second Affiliated Hospital of Zhongshan University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Binlin', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': ""Department of Breast Surgery, Xinjiang Cancer Hospital, Wulumuqi, Xinjiang, People's Republic of China.""}, {'ForeName': 'Pingqing', 'Initials': 'P', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Shanghai Sixth People's Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhuang', 'Affiliation': ""Department of Breast Surgery, Shanghai First Maternity and Infant Hospital Corporation, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Shanghai General Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Department of Breast Surgery, Peking Union Medical College Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Continuing Education and Technology Services Department, Chinese Anti-Cancer Association, Tianjin, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': ""Department of Cancer Prevention, Fudan University Shanghai Cancer Center, and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02474']
289,32273165,Staged horizontal bone augmentation for dental implants in aesthetic zones: A prospective randomized controlled clinical trial comparing a half-columnar bone block harvested from the ramus versus a rectangular bone block from the symphysis.,"In this study, the clinical outcomes of horizontal ridge augmentation using half-columnar bone grafts from the ramus (group I: 27 patients, 32 implants) versus rectangular bone grafts from the symphysis (group II: 19 patients, 27 implants) were compared; grafts were combined with organic bovine bone and collagen membrane. Cone beam computed tomography images were obtained preoperatively, immediately after restoration (baseline), and 1 year after loading. Four months after grafting, horizontal bone resorption at the alveolar crest did not differ significantly between the two groups (P=0.291). At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041). One year after loading, horizontal bone resorption in group I was lower than that in group II, with no significant difference. The residual thickness of the labial bone at the implant site in group I was significantly higher than that in group II. Horizontal ridge augmentation with either a half-columnar autogenous graft from the ramus or a rectangular autogenous graft from the symphysis can provide acceptable results in aesthetic regions. The half-columnar group demonstrated better graft stability both at 4 months after augmentation and 1 year after loading.",2020,"At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041).",['dental implants in aesthetic zones'],"['organic bovine bone and collagen membrane', 'rectangular bone grafts from the symphysis', 'Horizontal ridge augmentation with either a half-columnar autogenous graft', 'Staged horizontal bone augmentation', 'horizontal ridge augmentation using half-columnar bone grafts']","['horizontal bone resorption', 'alveolar crest, horizontal bone resorption', 'graft stability', 'residual thickness of the labial bone']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205142', 'cui_str': 'Rectangular'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0559189', 'cui_str': 'Autograft'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",,0.0253299,"At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041).","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China; National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Haidian District, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China; National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Haidian District, Beijing, China. Electronic address: tang_zhihui@live.cn.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.12.010']
290,32275852,Storytelling Through Music: A Multidimensional Expressive Arts Intervention to Improve Emotional Well-Being of Oncology Nurses.,"PURPOSE


Rates of burnout among health care professionals are rising. Oncology nurses are at the forefront of cancer care, and maintenance of their well-being is crucial to delivering high-quality care to people with cancer. The purpose of this pilot study was to implement a novel intervention, Storytelling Through Music, and examine the effects on depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction in oncology nurses.
METHODS


This two-group (intervention and control), quasi-experimental study of a 6-week intervention combined storytelling, reflective writing, songwriting, and stress management skills.
RESULTS


Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years. Both groups improved significantly over time on all measures. Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
CONCLUSION


There are few opportunities for health care professionals to reflect on the impact of caregiving. The Storytelling Through Music intervention provided a structured space for reflection by participants, individually and among their peers, which decreased loneliness and increased self-compassion. Both factors relate to the burnout that affects the oncology health care workforce.",2020,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
","['Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years']","['intervention combined storytelling, reflective writing, songwriting, and stress management skills', 'Storytelling Through Music', 'Multidimensional Expressive Arts Intervention']","['insomnia', 'loneliness', 'self-awareness', 'depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction', 'greater self-compassion']","[{'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",43.0,0.0259643,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Phillips', 'Affiliation': 'The Phyllis F. Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Volker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Davidson', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}]",JCO oncology practice,['10.1200/JOP.19.00748']
291,32279561,Long-Term Outcomes After Revascularization for Stable Ischemic Heart Disease: An Individual Patient-Level Pooled Analysis of 19 Randomized Coronary Stent Trials.,"BACKGROUND


Whether revascularization improves prognosis in stable ischemic heart disease is controversial.
METHODS


Individual patient-level data from 19 prospective, randomized stent trials were pooled. Rates of 5-year major adverse cardiovascular events (MACE; a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed and compared after percutaneous coronary intervention with bare-metal stents (BMS) and first-generation and second-generation drug-eluting stents (DES1 and DES2, respectively). Poisson multivariable regression analysis was performed to identify predictors of adverse events.
RESULTS


Among 10 987 patients treated with percutaneous coronary intervention for stable ischemic heart disease, 1550, 2776, and 6661 received BMS, DES1, and DES2, respectively. The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%,  P <0.0001). However, MACE rates between 1 and 5 years increased from BMS to DES1, then declined with DES2 (BMS: 7.4% versus DES1: 10.2%, DES2: 8.5%,  P =0.02).
CONCLUSIONS


Patients with stable ischemic heart disease remain at substantial risk for long-term MACE after revascularization with percutaneous coronary intervention, even with contemporary DES. New approaches to reduce the ongoing risk of MACE beyond 1 year after stent implantation are necessary.",2020,"The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%,  P <0.0001).","['Patients with stable ischemic heart disease remain at substantial risk for long-term MACE after revascularization with percutaneous coronary intervention, even with contemporary DES', 'Stable Ischemic Heart Disease', 'Individual patient-level data from 19 prospective', 'Among 10\u2009987 patients treated with percutaneous coronary intervention for stable ischemic heart disease, 1550, 2776, and 6661 received BMS, DES1, and DES2, respectively']",[],"['BMS to DES1', 'MACE rates', '5-year rates of MACE', 'Rates of 5-year major adverse cardiovascular events (MACE; a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]",[],"[{'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",10987.0,0.094386,"The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%,  P <0.0001).","[{'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (M.V.M., B.R., Z.A.A., M.P., B.S., Z.Z., R.M., A.M., M.B.L., A.J.K., G.W.S.).'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Zienkenhuis, Rotterdam, the Netherlands (P.C.S.).'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands (C.v.B.).'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (M.V.M., B.R., Z.A.A., M.P., B.S., Z.Z., R.M., A.M., M.B.L., A.J.K., G.W.S.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (M.V.M., B.R., Z.A.A., M.P., B.S., Z.Z., R.M., A.M., M.B.L., A.J.K., G.W.S.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, United Kingdom (P.W.S.).'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Irving Medical Center (M.V.M., B.R., Z.A.A., M.P., A.M., M.B.L., A.J.K.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (M.V.M., B.R., Z.A.A., M.P., B.S., Z.Z., R.M., A.M., M.B.L., A.J.K., G.W.S.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008565']
292,32279567,Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: The LF II Study.,"BACKGROUND


High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS). LFII was designed to assess the reproducibility and generalizability of the benefits of DCS observed in LF to inform the US Food and Drug Administration in a device registration decision.
METHODS


LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF. The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls.
RESULTS


A total of 1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure. Propensity-adjusted 365-day clinically indicated target lesion revascularization was significantly lower with DCS (7.2% versus 9.2%; hazard ratio, 0.72 [95% CI, 0.52-0.98];  P =0.0338 for superiority), as was the primary safety (cardiac death and myocardial infarction) composite (9.3% versus 12.4%; hazard ratio, 0.72 [95% CI, 0.55-0.94];  P =0.0150 for superiority). Stent thrombosis rates were 2.0% DCS and 2.2% bare metal stent. Major bleeding at 1 year occurred in 7.2% DCS patients and 7.2% bare metal stent.
CONCLUSIONS


LFII reproduces the results of the DCS arm of LF in an independent, predominantly North American cohort of HBR patients.",2020,"The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls.
","['High bleeding risk (HBR) patients undergoing', 'High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents', 'HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS', 'LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF', '1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure']",['percutaneous coronary intervention'],"['Stent thrombosis rates', 'primary safety (cardiac death and myocardial infarction) composite', 'Major bleeding', 'target lesion revascularization', 'target lesion revascularization) and safety (composite cardiac death and myocardial infarction']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1445093', 'cui_str': 'Drug coated stent'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1203.0,0.317294,"The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls.
","[{'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.W.K., S.V.R.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Hôpital de la Tour, Geneva, Switzerland (P.U.).'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Department of Medicine, Montreal Heart Institute, Québec, Canada (J.-F.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (T.M., Y.Z.).'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (T.M., Y.Z.).'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.W.K., S.V.R.).'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Price', 'Affiliation': 'Scripps Clinic, La Jolla, CA (M.J.P.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City (D.J.C.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Segeberger Kliniken GmbH, Bad Segeberg, Germany (M.A.-W.).'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and Hamilton Health Sciences, Ontario, Canada (S.R.M.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Faurie', 'Affiliation': 'Department of Cardiology, Groupe Hospitalier Mutualiste de Grenoble, France (B.F.).'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'McLaurin', 'Affiliation': 'AnMed Health, Anderson, SC (B.M.).'}, {'ForeName': 'Corie', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'Syntactx, New York, NY (C.D.).'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland (H.-P.S.).'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel Street, United Kingdom (S.P.).'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital (M.B.L.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008603']
293,32043473,Septic patients with cancer: Do prehospital antibiotics improve survival? A sub-analysis of the PHANTASi trial.,"BACKGROUND


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


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


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


Prehospital antibiotics did not improve overall survival. However, there was a significant reduction in 30-day readmissions.",2020,"There were however, significantly fewer 30-day readmissions (p = 0.031) in the intervention group of cancer patients (12.2% vs 5.7%).
","['Septic patients with cancer', 'enrolled patients with suspected sepsis who were transported to the emergency department by ambulance', 'patients who had cancer to those who did not', 'patients with cancer', 'septic patients with cancer']","['usual care', 'prehospital antibiotics', 'PHANTASi (PreHospital ANTibioitcs Against Sepsis', 'prehospital intravenous antibiotics']","['hospital mortality and 90-day mortality', 'survival', '30-day readmissions', 'overall survival', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2658.0,0.195409,"There were however, significantly fewer 30-day readmissions (p = 0.031) in the intervention group of cancer patients (12.2% vs 5.7%).
","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Nannan Panday', 'Affiliation': 'Section Acute Medicine, Department of Internal Medicine, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Schermer', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cooksley', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': ''}, {'ForeName': 'P W B', 'Initials': 'PWB', 'LastName': 'Nanayakkara', 'Affiliation': ''}]",The Netherlands journal of medicine,[]
294,32278330,The effect of two different irrigation needles on post-operative pain after pulpectomy in primary molar teeth: A randomized clinical study.,"BACKGROUND


Post-operative pain (PP) following pulpectomy is of concern for endodontic patients and dentists.
AIM


This study evaluated the intensity of PP following pulpectomy in primary maxillary molars, using two irrigation needles.
DESIGN


One hundred patients in ages ranging from 6-9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study. The participants were randomly assigned to two groups of 50 patients each, according to the type of irrigation needle used, that is, a conventional open-ended needle and a double side-vented needle. The teeth were obturated and then permanently restored. The presence of PP was assessed after six, 12, 24, 48, and 72 hours, and finally after one week, using a four-point pain intensity scale. The PP scores were then statistically analysed.
RESULTS


In 6, 12, and 24 hours time intervals, patients who had their teeth irrigated with the open-ended needle exhibited more intense PP than those who had their teeth irrigated with a double side-vented needle (P < .05). After 48 hours, 72 hours, and 1 week, however there was no significant difference between the groups (P > .05).
CONCLUSIONS


Side-vented needles may be preferred in order to decrease PP at the first 24 hours after pulpectomy in primary molars.",2020,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","['One hundred patients in ages ranging from 6 to 9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study', 'primary molar teeth', 'endodontic patients and dentists']","['conventional open-ended needle and a double side-vented needle', 'pulpectomy', 'irrigation needles']","['PP scores', 'postoperative pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0442741', 'cui_str': 'Non-vital'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0418295,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Topçuoğlu', 'Affiliation': 'Private Practice in Pedodontics, Kayseri, Turkey.'}, {'ForeName': 'Hüseyin Sinan', 'Initials': 'HS', 'LastName': 'Topçuoğlu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Delikan', 'Affiliation': 'Department of Pedodontics Dentistry, Nuh Naci Yazgan University, Kayseri, Turkey.'}, {'ForeName': 'Seçil', 'Initials': 'S', 'LastName': 'Çalişkan', 'Affiliation': 'Department of Pedodontics Dentistry, Eskişehir Osmangazi University, Eskişehir, Turkey.'}]",International journal of paediatric dentistry,['10.1111/ipd.12652']
295,31767947,Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.,"STUDY DESIGN


Clinical trial.
OBJECTIVE


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


Community.
METHOD


Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability.
RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 10 5  ± 0.9 × 10 5  mmHg • beat) than placebo (4.4 × 10 5  ± 0.6 × 10 5  mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use.
CONCLUSIONS


At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.",2020,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","['Participants (n\u2009=\u200913; age 44.0\u2009±\u20093.3\xa0years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring', 'during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia', 'Community']","['lidocaine', 'standard lubricant (placebo', 'placebo', 'lidocaine lubricant', 'lidocaine lubricant (Xylocaine 2%) ameliorates AD', 'Lidocaine lubricant']","['autonomic function', 'Overall, SAP', 'maximum SAP', 'Heart rate and rhythm disturbances', 'Bowel care duration', 'low-frequency systolic arterial pressure (LF SAP) variability']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0238015', 'cui_str': 'Spinal Autonomic Dysreflexia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.186011,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","[{'ForeName': 'Vera-Ellen M', 'Initials': 'VM', 'LastName': 'Lucci', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Inskip', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Shirromi', 'Initials': 'S', 'LastName': 'Sarveswaran', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Willms', 'Affiliation': 'International Collaboration on Repair and Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Claydon', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada. victoria_claydon@sfu.ca.'}]",Spinal cord,['10.1038/s41393-019-0381-2']
296,32271671,Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx.,"PURPOSE


Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI.
METHODS


Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors.
RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant.
CONCLUSION


Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.",2020,"RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","['Women', '552 evaluable women using the', 'women with early breast cancer', 'Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX']","['37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire', 'chemoendocrine therapy (CT+E) versus endocrine therapy alone (E', 'Endocrine Therapy', 'Chemoendocrine Therapy', 'Adjuvant CT+E', 'CT+E', 'TAILORx']","['FACT-Cog PCI scores', '20-item Perceived Cognitive Impairment (PCI) scale', 'Cognitive Impairment', 'PCI change scores', 'CRCI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",552.0,0.0961332,"RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","[{'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Canadian Cancer Trials Group, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Madison, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Virginia Commonwealth University Massey Cancer Center Minority/Underserved National Cancer Institute Community Oncology Research Program, Richmond, VA.'}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Worta J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01866']
297,32271672,Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer.,"PURPOSE


Platinum-based chemotherapy for first-line treatment of metastatic urothelial cancer is typically administered for a fixed duration followed by observation until progression. ""Switch maintenance"" therapy with PD-1 blockade at the time of chemotherapy cessation may be attractive for mechanistic and pragmatic reasons.
PATIENTS AND METHODS


Patients with metastatic urothelial cancer achieving at least stable disease on first-line platinum-based chemotherapy were enrolled. Patients were randomly assigned double-blind 1:1 to switch maintenance pembrolizumab 200 mg intravenously once every 3 weeks versus placebo for up to 24 months. Patients with disease progression on placebo could cross over to pembrolizumab. The primary objective was to determine the progression-free survival. Secondary objectives included determining overall survival as well as treatment outcomes according to PD-L1 combined positive score (CPS).
RESULTS


Between December 2015 and November 2018, 108 patients were randomly assigned to pembrolizumab (n = 55) or placebo (n = 53). The objective response rate was 23% with pembrolizumab and 10% with placebo. Treatment-emergent grade 3-4 adverse events occurred in 59% receiving pembrolizumab and 38% of patients receiving placebo. Progression-free survival was significantly longer with maintenance pembrolizumab versus placebo (5.4 months [95% CI, 3.1 to 7.3 months]  v  3.0 months [95% CI; 2.7 to 5.5 months]; hazard ratio, 0.65; log-rank  P  = .04; maximum efficiency robust test  P  = .039). Median overall survival was 22 months (95% CI, 12.9 months to not reached) with pembrolizumab and 18.7 months (95% CI, 11.4 months to not reached) with placebo. There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
CONCLUSION


Switch maintenance pembrolizumab leads to additional objective responses in patients achieving at least stable disease with first-line platinum-based chemotherapy and prolongs progression-free survival in patients with metastatic urothelial cancer.",2020,"There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
","['Patients with metastatic urothelial cancer achieving at least stable disease on first-line platinum-based chemotherapy were enrolled', 'metastatic urothelial cancer', 'Patients with disease progression on', 'Patients With Metastatic Urothelial Cancer', 'patients with metastatic urothelial cancer', '108 patients', 'Between December 2015 and November 2018']","['Platinum-based chemotherapy', 'placebo', 'First-Line Chemotherapy', 'Maintenance Pembrolizumab Versus Placebo', 'maintenance pembrolizumab 200 mg intravenously once every 3 weeks versus placebo', 'pembrolizumab']","['overall survival as well as treatment outcomes according to PD-L1 combined positive score (CPS', 'objective response rate', 'adverse events', 'progression-free survival or overall survival', 'Median overall survival', 'Progression-free survival', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",108.0,0.535753,"There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Division of Hematology and Medical Oncology, The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mortazavi', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, and the Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Milowsky', 'Affiliation': 'Division of Hematology and Medical Oncology, University of North Carolina School of Medicine, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Division of Oncology, University of Utah, Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fleming', 'Affiliation': 'US Oncology Research, Virginia Oncology Associates, Hampton, VA.'}, {'ForeName': 'Long H', 'Initials': 'LH', 'LastName': 'Dang', 'Affiliation': 'Ochsner Medical Center, Baton Rouge, LA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Walling', 'Affiliation': 'Community Regional Cancer Care, Community Health Network, Indianapolis, IN.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Alter', 'Affiliation': 'John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Kassar', 'Affiliation': 'Community Hospital, Munster, IN.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""University of Arizona Cancer Center at Dignity Health St Joseph's Hospital and Medical Center, Phoenix, AZ.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Davis', 'Affiliation': 'Division of Hematology and Medical Oncology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Picus', 'Affiliation': 'Division of Oncology, Department of Medicine, and Siteman Cancer Center, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Philips', 'Affiliation': 'Division of Hematology and Medical Oncology, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Division of Oncology, University of Southern California Norris Comprehensive Cancer Center, Keck School of Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'G Kenneth', 'Initials': 'GK', 'LastName': 'Haines', 'Affiliation': 'Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Hahn', 'Affiliation': 'Department of Oncology and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Menggang', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03091']
298,31700147,The effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury: an exploratory study.,"STUDY DESIGN


Experimental before-after design.
OBJECTIVES


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


Research laboratory.
METHODS


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


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


Our findings provide initial evidence that local cooling rates affect skin blood flow responses under externally applied pressure in people with SCI.",2020,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"['people with spinal cord injury', 'people with spinal cord injury (SCI', 'people with SCI', 'Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls']","['laser Doppler and heating and cooling probes', 'local cooling rates']","['peak blood flow, recovery time, and total blood flow', 'cooling rate at -10', 'smaller skin blood flow response', 'cooling rate', 'sacral skin blood flow and temperature', 'recovery time', 'Blood flow responses']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",17.0,0.0858534,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"[{'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. yjan@illinois.edu.'}]",Spinal cord,['10.1038/s41393-019-0378-x']
299,31996581,Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial.,"BACKGROUND


There is limited evidence on the long-term efficacy of transanal hemorrhoidal dearterialization compared with hemorrhoidectomy. Most studies investigated short-term effects with postoperative pain as the primary outcome. Being a benign disease, the long-term goal of treatment for hemorrhoids is the resolution of symptoms and improvement of quality of life.
OBJECTIVE


The purpose of this study was to compare the effect of minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization on patient-reported symptoms.
DESIGN


This was an open-label randomized controlled trial.
SETTINGS


This was a single-center study.
PATIENTS


Patients with symptomatic hemorrhoids grade II to IV (Goligher's classification) were included.
INTERVENTIONS


Patients were randomly allocated to minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization.
MAIN OUTCOME MEASURES


The primary outcome was symptoms assessed by the Hemorrhoidal Disease Symptom Score 1 year postoperatively. Secondary outcomes included health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence, and hospital costs.
RESULTS


Forty-eight patients received minimal open hemorrhoidectomy, and 50 patients received transanal hemorrhoidal dearterialization. No difference in symptom score at 1-year follow-up was found. Median (range) symptom score was 3 (0-17) after minimal open hemorrhoidectomy and 5 (0-17) after transanal hemorrhoidal dearterialization (median difference = -1.0 (95% CI, -3.0 to 0.0); p = 0.15). Residual hemorrhoidal prolapse was reported more frequently (p = 0.008), and more patients had treatment for recurrence after transanal hemorrhoidal dearterialization (7 vs 0 patients; p = 0.013). Patient satisfaction was higher after minimal open hemorrhoidectomy (p = 0.049). No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p > 0.05). Transanal hemorrhoidal dearterialization was more expensive (median difference = &OV0556;555 (95% CI, &OV0556;472-&OV0556;693); p < 0.001).
LIMITATIONS


No blinding was included in this study.
CONCLUSION


No difference was found in symptom score 1 year postoperatively. Minimal open hemorrhoidectomy had a better effect on the hemorrhoidal prolapse and higher patient satisfaction. More patients needed treatment for recurrence after transanal hemorrhoidal dearterialization. Minimal open hemorrhoidectomy has an immediate postoperative course similar to transanal hemorrhoidal dearterialization. See Video Abstract at http://links.lww.com/DCR/B152.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02061176. HEMORROIDECTOMíA MíNIMA ABIERTA VERSUS DESARTERIALIZACIóN HEMORROIDAL TRANSANAL: EL EFECTO SOBRE LOS SíNTOMAS: UN ESTUDIO ABIERTO CONTROLADO Y ALEATORIZADO: Hay evidencia limitada sobre la eficacia a largo plazo de la desarterialización hemorroidal transanal en comparación con la hemorroidectomía. La mayoría de los estudios han investigado los efectos a corto plazo con el dolor postoperatorio como el resultado primario. Al ser una enfermedad benigna, el objetivo a largo plazo del tratamiento de la enfermedad hemorroidal es la resolución de los síntomas y la mejora en la calidad de vida.Comparar el efecto de la hemorroidectomía abierta mínima versus la desarterialización hemorroidal transanal en los síntomas reportados por el paciente.Ensayo controlado aleatorizado abierto.Estudio en sede única.Pacientes con enfermedad hemorroidal sintomática de grado II-IV (clasificación de Goligher).Los pacientes fueron asignados aleatoriamente a hemorroidectomía mínima abierta o desarterialización hemorroidal transanal.El resultado primario fueron los síntomas evaluados por el Score de Síntomas de Enfermedad Hemorroidal un año después de la operación. Los resultados secundarios incluyeron calidad de vida relacionada con la salud, satisfacción del paciente, dolor y recuperación postoperatorios, eventos adversos, recurrencia y costos hospitalarios.Cuarenta y ocho pacientes recibieron hemorroidectomía abierta mínima y cincuenta pacientes recibieron desarterialización hemorroidal transanal. No se encontraron diferencias en la puntuación de los síntomas al año de seguimiento. La puntuación mediana (rango) de síntomas fue 3 (0-17) después de una hemorroidectomía mínima abierta y 5 (0-17) después de la desarterialización hemorroidal transanal (diferencia mediana [IC95%]: -1.0 [-3.0-0.0], p = 0.15). El prolapso hemorroidal residual se informó con mayor frecuencia (p = 0.008) y más pacientes recibieron tratamiento por recurrencia después de la desarterialización hemorroidal transanal (7 frente a 0 pacientes, p = 0.013). La satisfacción del paciente fue mayor después de una hemorroidectomía abierta mínima (p = 0.049). No se encontraron diferencias en el impacto sobre la calidad de vida relacionada con la salud, el dolor postoperatorio promedio y máximo, la recuperación o los eventos adversos (p> 0.05). La desarterialización hemorroidal transanal fue más costosa (diferencia mediana [IC95%]: &OV0556; 555 [472-693], p <0.001).Estudio sin cegamiento.No se encontraron diferencias en la puntuación de los síntomas a un año después de la operación. La hemorroidectomía mínima abierta tuvo un mejor efecto sobre el prolapso hemorroidal y una mayor satisfacción del paciente. Más pacientes necesitaron tratamiento para la recurrencia después de la desarterialización hemorroidal transanal. La hemorroidectomía abierta mínima tiene un curso postoperatorio inmediato similar a la desarterialización hemorroidal transanal. Consulte Video Resumen en http://links.lww.com/DCR/B152. (Traducción-Dr. Jorge Silva Velazco).ClinicalTrials.gov Identifier: NCT02061176.",2020,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[""Patients with symptomatic hemorrhoids grade II-IV (Goligher's classification"", 'Single-center study']","['minimal open hemorrhoidectomy', 'hemorrhoidectomy', 'Transanal Hemorrhoidal Dearterialization', 'Transanal hemorrhoidal dearterialization', 'transanal hemorrhoidal dearterialization', 'minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization', 'Minimal Open Hemorrhoidectomy', 'minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization']","['health-related quality of life, average and peak postoperative pain, recovery, or adverse events', 'symptom score', 'Hemorrhoidal Disease Symptom Score one year postoperatively', 'Residual hemorrhoidal prolapse', 'Patient satisfaction', 'Median (range) symptom score', 'hemorrhoidal prolapse and higher patient satisfaction', 'health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy (procedure)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0743887,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[{'ForeName': 'Håvard D', 'Initials': 'HD', 'LastName': 'Rørvik', 'Affiliation': ''}, {'ForeName': 'André H', 'Initials': 'AH', 'LastName': 'Campos', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Styr', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ilum', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Grant K', 'Initials': 'GK', 'LastName': 'McKinstry', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brandstrup', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Olaison', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001588']
300,32267724,"Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin. A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial.","Rationale:  Chronic obstructive pulmonary disease (COPD) exacerbations are prone to nonrecovery, but there are no data about the effectiveness of retreatment for these prolonged events. We examined whether further therapy with ciprofloxacin for incompletely resolved COPD exacerbations prolonged the time until the next event. Objectives:  To assess whether incompletely recovered COPD exacerbations benefit from additional treatment with ciprofloxacin, at Day 14. Methods:  In a multicenter, randomized double-blind placebo-controlled trial, we studied retreatment with oral ciprofloxacin 500 mg or matched placebo twice daily for 7 days in patients with Global Initiative for Chronic Obstructive Lung Disease stage II-IV COPD and persistent symptoms and/or serum C-reactive protein ≥8 mg/L initiated 14 (±3) days after an index COPD exacerbation. The primary outcome was the time to the next exacerbation within a 90-day period. Measurements and Main Results:  Among 826 patients screened at four centers, 144 eligible participants with incomplete recovery were randomized to receive ciprofloxacin ( n  = 72) or placebo ( n  = 72). Within 90 days of randomization, 57% of the patients in the ciprofloxacin group and 53% in the placebo group experienced one or more exacerbations. The median time to the next exacerbation was 32.5 days (interquartile range 13-50) in the placebo arm and 34 days (interquartile range 17-62) in the ciprofloxacin arm, which was not significantly different (adjusted hazard ratio, 1.07; 95% confidence interval, 0.68-1.68;  P  = 0.76). No significant differences were seen in quality-of-life scores or lung function between the treatment groups. Conclusions:  In patients with persistent symptoms and/or raised C-reactive protein 14 days after a COPD exacerbation, an additional course of ciprofloxacin resulted in no additional benefit compared with placebo. This suggests that nonrecovered exacerbations are not driven by ongoing bacterial infection and may potentially be targeted with antiinflammatory therapy.Clinical trial registered with www.clinicaltrials.gov (NCT02300220).",2020,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","['826 patients screened at 4 centres', '144 eligible participants with incomplete recovery', 'patients with GOLD stage II - IV COPD with persistent symptoms and/or serum C-reactive protein (CRP']","['oral ciprofloxacin 500mg or matched placebo', 'placebo', 'Ciprofloxacin', 'ciprofloxacin', 'Placebo']","['exacerbations', 'median time to the next exacerbation', 'COPD Exacerbations', 'time to the next exacerbation within a 90-day period', 'quality of life scores or lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1123173', 'cui_str': 'Ciprofloxacin 500 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.771152,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","[{'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Ritchie', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Brill', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Vlies', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Finney', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Alves-Moreira', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Dexter J', 'Initials': 'DJ', 'LastName': 'Wiseman', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Walker', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ""Institute of Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Elkin', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallia', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Hub for Trials Methodology Research, Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Gavin C', 'Initials': 'GC', 'LastName': 'Donaldson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-2058OC']
301,31686586,Arthroscopic debridement does not enhance surgical treatment of intra-articular distal radius fractures: a randomized controlled trial.,"The aim of this study was to determine the difference in functional outcomes after open reduction and internal fixation (ORIF) with and without arthroscopic debridement in adults with displaced intra-articular distal radius fractures. In this multicentre trial, 50 patients were randomized between ORIF with or without arthroscopic debridement. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcome measures were Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, pain scores, range of wrist motion, grip strength, and complications. Median PRWE was worse for the intervention group at 3 months and was equal for both groups at 12 months. The secondary outcome measures did not show consistent patterns of differences at different time-points of follow-up. We conclude that patients treated with additional arthroscopy to remove intra-articular hematoma and debris did not have better outcomes than those treated with ORIF alone. We therefore do not recommend arthroscopy for removal of hematoma and debris when surgically fixing distal radius fractures.  Level of evidence:  I.",2020,Median PRWE was worse for the intervention group at 3 months and was equal for both groups at 12 months.,"['50 patients', 'intra-articular distal radius fractures', 'adults with displaced intra-articular distal radius fractures']","['ORIF with or without arthroscopic debridement', 'Arthroscopic debridement', 'internal fixation (ORIF) with and without arthroscopic debridement']","['Patient-Rated Wrist Evaluation (PRWE) score', 'Median PRWE', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, pain scores, range of wrist motion, grip strength, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",50.0,0.194845,Median PRWE was worse for the intervention group at 3 months and was equal for both groups at 12 months.,"[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Selles', 'Affiliation': 'Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Marjolein A M', 'Initials': 'MAM', 'LastName': 'Mulders', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'Colaris', 'Affiliation': 'Department of Orthopedic Surgery, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Heijl', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Berry I', 'Initials': 'BI', 'LastName': 'Cleffken', 'Affiliation': 'Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Niels W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419866128']
302,32268815,"Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.","In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.",2020,"Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms.","['relapsed or refractory multiple myeloma', 'patients with RRMM', 'lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients']","['bortezomib and low-dose dexamethasone (PVd', 'bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone']","['progression-free survival (PFS', 'Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index', 'HRQoL']","[{'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.101986,"Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany and University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Munci', 'Initials': 'M', 'LastName': 'Yagci', 'Affiliation': 'Gazi Universitesi Tip Fakultesi Hastanesi, Besevler, Turkey.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Kanate', 'Affiliation': 'Mary Babb Randolph Cancer Center, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Vural', 'Affiliation': 'Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cascavilla', 'Affiliation': 'Fondazione IRCSS Casa Sollievo Della Sofferenza, San Giovanni Rotundo, Italy.'}, {'ForeName': 'Supratik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'New Cross Hospital, Wolverhampton, University Of Wolverhampton, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Haematology, Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Byeff', 'Affiliation': 'Cancer Center of Central Connecticut, Southington, CT, USA.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hus', 'Affiliation': 'Samodzielny Publiczny Szpital Nr 1 W Lublinie, Lublin, Poland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodríguez-Otero', 'Affiliation': 'University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Muelduer', 'Affiliation': 'Medizinische Universitaet Wien, Vienna, Austria.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Anttila', 'Affiliation': 'Division of Hematology, Helsinki University and Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hayden', 'Affiliation': 'St James Hospital-Cancer Clinical Trials Office, Dublin, Ireland.'}, {'ForeName': 'Maria-Theresa', 'Initials': 'MT', 'LastName': 'Krauth', 'Affiliation': 'Department of Internal Medicine I, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Lucio', 'Affiliation': 'Champalimaud Center for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Hadassah Hospital, Jerusalem, Israel.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Mendeleeva', 'Affiliation': 'National Research Center for Hematology of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Shien', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Evidera, Waltham, MA, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Grote', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Tsvetan', 'Initials': 'T', 'LastName': 'Biyukov', 'Affiliation': 'Celgene International Sàrl, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Dhanasiri', 'Affiliation': 'Celgene International Sàrl, a Bristol Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1747066']
303,32169689,Prospective testing of a neurophysiologic biomarker for treatment decisions in major depressive disorder: The PRISE-MD trial.,"Management of Major Depressive Disorder (MDD) might be improved by a biomarker to predict whether a selected medication is likely to lead to remission. We previously reported on a quantitative electroencephalogram-based biomarker, the Antidepressant Treatment Response (ATR) index, that integrated recordings at baseline and after one week of treatment. The present study prospectively tested whether treatment directed by the biomarker increased the likelihood of remission; we hypothesized that continued treatment with a drug predicted to lead to remission (i.e., high ATR values) would be associated with better outcomes than if the drug was predicted not to lead to remission (i.e., low ATR values). We enrolled 180 adult outpatients with unipolar MDD from the community. After one week of escitalopram treatment to determine the biomarker, stratified randomization (high vs. low ATR) was used to assign subjects to either continued escitalopram or a switch to bupropion as a blinded control condition, for seven additional weeks. For the 73 evaluable subjects assigned to continued escitalopram treatment, the remission rate was significantly higher for those in whom ATR had predicted remission versus non-remission (60.4% vs. 30.0%, respectively, p = 0.01). Accuracy was enhanced by combining 1-week depressive symptom change with ATR (68.6% vs 28.9%). This prospective validation study supports further development of the ATR biomarker, alone or together with early symptom change, to improve care by identifying individuals unlikely to remit with their current treatment, and support the decision to change treatment after one week rather than after failing a full, prolonged course of medication.",2020,"For the 73 evaluable subjects assigned to continued escitalopram treatment, the remission rate was significantly higher for those in whom ATR had predicted remission versus non-remission (60.4% vs. 30.0%, respectively, p = 0.01).","['major depressive disorder', '180 adult outpatients with unipolar MDD from the community', 'Major Depressive Disorder (MDD']",['neurophysiologic biomarker'],"['likelihood of remission', 'remission rate']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",180.0,0.0263587,"For the 73 evaluable subjects assigned to continued escitalopram treatment, the remission rate was significantly higher for those in whom ATR had predicted remission versus non-remission (60.4% vs. 30.0%, respectively, p = 0.01).","[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Cook', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA; Department of Bioengineering, Henry Samueli School of Engineering and Applied Science at UCLA, 410 Westwood Plaza, Los Angeles, CA, USA.'}, {'ForeName': 'Aimee M', 'Initials': 'AM', 'LastName': 'Hunter', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA.'}, {'ForeName': 'Marissa M', 'Initials': 'MM', 'LastName': 'Caudill', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Leuchter', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA. Electronic address: afl@ucla.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.02.028']
304,32268604,Extracellular Vesicle Biomarkers Reveal Inhibition of Neuroinflammation by Infliximab in Association with Antidepressant Response in Adults with Bipolar Depression.,"Accumulating evidence suggests that neuroinflammation is involved in bipolar disorder (BD) pathogenesis. The tumor necrosis factor-alpha (TNF-α) antagonist infliximab was recently reported to improve depressive symptoms in a subpopulation of individuals with BD and history of childhood maltreatment. To explore the mechanistic mediators of infliximab's effects, we investigated its engagement with biomarkers of cellular response to inflammation derived from plasma extracellular vesicles enriched for neuronal origin (NEVs). We hypothesized that infliximab, compared to placebo, would decrease TNF-α receptors (TNFRs) and nuclear factor-kappa B (NF-κB) pathway signaling biomarkers, and that history of childhood abuse would moderate infliximab's effects. We immunocaptured NEVs from plasma samples collected at baseline and at weeks 2, 6, and 12 (endpoint) from 55 participants of this clinical trial and measured NEV biomarkers using immunoassays. A subset of participants ( n  = 27) also underwent whole-brain magnetic resonance imaging at baseline and endpoint. Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  p  = 0.003), and inhibitor of NF-κB (IκBα) (χ 2  = 7.990,  p  = 0.046), indicating that higher levels of physical abuse were associated with larger biomarker decreases over time. Moreover, the antidepressant response to infliximab was moderated by TNFR1 (χ 2  = 7.997,  p  = 0.046). In infliximab-treated participants, reductions in TNFR1 levels were associated with improvement of depressive symptoms, an effect not detected in the placebo group. Conversely, reductions in TNFR1 levels were associated with increased global cortical thickness in infliximab- (r = -0.581,  p  = 0.029), but not placebo-treated, patients (r = 0.196,  p  = 0.501). In conclusion, we report that NEVs revealed that infliximab engaged the TNFR/NF-κB neuro-inflammatory pathway in individuals with BD, in a childhood trauma-dependent manner, which was associated with clinical response and brain structural changes.",2020,"Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  ",['Adults with Bipolar Depression'],"['infliximab', 'placebo']","['TNFR1 levels', 'global cortical thickness', 'inhibitor of NF-κB (IκBα)\uf061', 'depressive symptoms', 'TNF-α receptors (TNFRs) and nuclear factor-kappa B (NF-κB) pathway signaling biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0255808', 'cui_str': 'Lymphocyte antigen CD120A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",55.0,0.172907,"Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  ","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Francheska', 'Initials': 'F', 'LastName': 'Delgado-Peraza', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Raison', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, WI 53706, USA.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nogueras-Ortiz', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}]",Cells,['10.3390/cells9040895']
305,32032196,"Prospective, Randomized Study on the Use of Prosthetic Mesh to Prevent a Parastomal Hernia in a Permanent Colostomy: Results of a Long-term Follow-up.","BACKGROUND


Parastomal hernias are common with permanent colostomies and prone to complications. The short-term results of trials of parastomal hernia prevention are widely published, but long-term results are scarce.
OBJECTIVE


The aim of the study is to detect the long-term effects and safety of preventive intra-abdominal parastomal mesh.
DESIGN


This is a long-term follow-up of a previous prospective randomized, controlled multicenter trial.
SETTINGS


This study was conducted at 2 university hospitals and 3 central hospitals in Finland.
PATIENTS


Patients who had a laparoscopic abdominoperineal resection for rectal cancer between 2010 and 2013 were included in the study and invited for a follow-up visit.
MAIN OUTCOME MEASURES


The primary outcomes measured were clinical and radiological parastomal hernias.
RESULTS


Twenty subjects in the mesh group and 15 in the control group attended the follow-up visit with a median follow-up period of 65 (25th-75th percentiles, 49-91) months. A clinically detectable parastomal hernia was present in 4 of 20 (20.0%) and 5 of 15 (33.3%) subjects in the mesh and control groups (p = 0.45). A radiological parastomal hernia was present in 9 of 19 (45.0%) subjects in the mesh group and 7 of 12 (58.3%) subjects in the control group (p = 0.72). However, when all subjects (n = 70, 1:1) who attended the 12-month follow-up were screened for long-term results according to register data, 9 of 35 (25.9%) subjects in the mesh group and 16 of 35 (45.6%) subjects in control group were diagnosed with a parastomal hernia during the follow-up period (p = 0.10). In addition, only 1 of 35 (2.7%) subjects in the mesh group but 6 of 35 (17.1%) subjects in the control group underwent a parastomal hernia operation during the long-term follow-up (p = 0.030).
LIMITATIONS


The study is limited by the small number of patients.
CONCLUSION


Prophylactic intra-abdominal keyhole mesh did not decrease the rate of clinically detectable hernias but reduced the need for the surgical repair of parastomal hernias. Further trials are needed to identify a more efficient method to prevent parastomal hernias. See Video Abstract at http://links.lww.com/DCR/B171.
CLINICAL TRIAL REGISTRATION


https://clinicaltrials.gov. Identifier: NCT02368873. ESTUDIO PROSPECTIVO ALEATORIZADO SOBRE EL USO DE MALLA PROTÉSICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMÍA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCIÓN DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomías permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevención de la hernia parastomal se publican ampliamente, pero los resultados a largo plazo son escasos.El objetivo del estudio es detectar los efectos a largo plazo y la seguridad de la malla parastomal intraabdominal preventiva.Este es un seguimiento a largo plazo de un estudio aleatorizado prospectivo, controlado y multicentrico previo.Este estudio se realizó en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una resección abdominoperineal laparoscópica por cáncer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clínicas y radiológicas.Veinte sujetos en el grupo de malla y 15 en el grupo control asistieron a la visita de seguimiento con una mediana de seguimiento de 65 meses (25-75 ° percentil 49-91). Una hernia paraestomal clínicamente detectable estuvo presente en 4/20 (20.0%) y 5/15 (33.3%) en los grupos de malla y control, respectivamente (p = 0.45). Una hernia parastomal radiológica estuvo presente en 9/19 (45.0%) en el grupo de malla y 7/12 (58.3%) en el grupo de control (p = 0.72). Sin embargo, cuando todos los sujetos (n = 70, 1: 1) que asistieron a los 12 meses de seguimiento fueron evaluados para obtener resultados a largo plazo de acuerdo con los datos del registro, 9/35 (25.9%) sujetos en el grupo de malla y 16/35 (45,6%) sujetos en el grupo control fueron diagnosticados con una hernia paraestomal durante el período de seguimiento (p = 0,10). Además, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operación de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio está limitado por un pequeño número de pacientes.La malla intra-abdominal profiláctica en ojo de cerradura no disminuyó la tasa de hernias clínicamente detectables, pero redujo la necesidad de la reparación quirúrgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un método más eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traducción-Dr. Gonzalo Hagerman).NCT02368873.",2020,A radiological parastomal hernia was present in 9/19 (45.0%) in the mesh group and 7/12 (58.3%) in the control group (p=0.72).,"['Patients who had a', 'two university hospitals and three central hospitals in Finland', 'for rectal cancer 2010-2013 were included in the study and invited for a follow-up visit']","['Prosthetic Mesh', 'laparoscopic abdominoperineal resection', 'preventive intra-abdominal parastomal mesh']","['parastomal hernia operation', 'Clinical and radiological parastomal hernias', 'radiological parastomal hernia', 'parastomal hernia', 'rate of clinically detectable hernias']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal Excision'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",,0.0316164,A radiological parastomal hernia was present in 9/19 (45.0%) in the mesh group and 7/12 (58.3%) in the control group (p=0.72).,"[{'ForeName': 'Elisa J', 'Initials': 'EJ', 'LastName': 'Mäkäräinen-Uhlbäck', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Kai H B', 'Initials': 'KHB', 'LastName': 'Klintrup', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mika T', 'Initials': 'MT', 'LastName': 'Vierimaa', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Monika A', 'Initials': 'MA', 'LastName': 'Carpelan-Holmström', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki A O', 'Initials': 'JAO', 'LastName': 'Kössi', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Matti V', 'Initials': 'MV', 'LastName': 'Kairaluoma', 'Affiliation': 'Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Pasi P', 'Initials': 'PP', 'LastName': 'Ohtonen', 'Affiliation': ''}, {'ForeName': 'Pirita R', 'Initials': 'PR', 'LastName': 'Tahvonen', 'Affiliation': 'Central Hospital of Lapland, Rovaniemi, Finland.'}, {'ForeName': 'Tero T', 'Initials': 'TT', 'LastName': 'Rautio', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001599']
306,32259266,Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.,"Importance


The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
Objective


To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
Design, Setting, and Participants


The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders.
Discussion


The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.",2020,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","['patients who underwent fracture repair', '1540 patients with open extremity fractures from at least 12 hospitals', 'patients with open extremity fractures and patients with closed lower extremity or pelvic fractures', 'patients with open extremity fractures', '1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals', 'Patients', 'Open Fractures', 'Fractured Extremities']","['Pre-Operative Aqueous Antiseptic Skin Solution', 'isopropyl alcohol', 'chlorhexidine', 'Fracture Repair', 'Iodophor vs Chlorhexidine Solutions', 'iodophor vs chlorhexidine solutions', 'isopropyl alcohol vs 0.7% iodine povacrylex', 'povidone-iodine']","['surgical site infection', 'unplanned fracture-related reoperations', 'surgical site infections and unplanned fracture-related reoperations', 'Surgical Site Infections and Unplanned Reoperations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1876049', 'cui_str': 'iodine povacrylex'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",6280.0,0.141164,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'Trauma Survivors Network, Falls Church, Virginia.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Garibaldi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, Colorado.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Petrisor', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mullins', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marvel', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Mossuto', 'Affiliation': 'Hamilton Health Science, Hamilton, Ontario, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Grissom', 'Affiliation': 'Trauma Survivor Network, Baltimore, Maryland.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Del Fabbro', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia.'}, {'ForeName': 'Haley K', 'Initials': 'HK', 'LastName': 'Demyanovich', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'I Leah', 'Initials': 'IL', 'LastName': 'Gitajn', 'Affiliation': 'Department of Orthopaedics, Dartmouth University, Hanover, New Hampshire.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': ""D'Alleyrand"", 'Affiliation': 'Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Friedrich', 'Affiliation': 'Washington, DC.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rivera', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fowler', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Jeray', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Marchand', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Manjari G', 'Initials': 'MG', 'LastName': 'Joshi', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Talbot', 'Affiliation': 'Canadian Armed Forces, Montreal, Qubec, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Camara', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Olivia Paige', 'Initials': 'OP', 'LastName': 'Szasz', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zura', 'Affiliation': 'Department of Orthopaedics, Louisiana State University Health, New Orleans.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Tanner', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Nguyen', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2215']
307,32269011,Autologous fat graft assisted by stromal vascular fraction improves facial skin quality: A randomized controlled trial.,"BACKGROUND


Cell-assisted lipotransfer (CAL) promotes the survival of fat grafts with high vascular density and improves skin quality by increasing collagen content. However, no study has quantified the changes on the skin surface, and rigorous methodological evaluations are still lacking.
DESIGN


Fifty patients were recruited and randomly divided into two groups: an experimental group (n = 25) that underwent a stromal vascular fraction (SVF)-assisted fat graft and a control group (n = 25) that underwent fat graft only.
METHODS


The SVF cells were counted, tested in terms of viability, and characterized. The volumes of whole faces were determined by using a 3D scanner and Geomagic software preoperation, immediately after surgery, and 6 months postoperation. Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins, were detected by a VISIA skin detector preoperation and 6 months postoperation. A visual analog scale was used for clinical evaluation.
RESULTS


The cell pellet contained 1-3 × 10 7 /mL of fresh SVF cells. The cell viability exceeded 98%. The immunophenotyping characteristics and stemness were consistent with the features of adipose- derived stem cells (ADSCs). The survival rate of SVF-enriched fat grafts was significantly higher than that of control grafts: 77.6%±11.6% versus 56.2%±9.5% (p<0.001). The VISIA values of wrinkles (19.3 ± 6.6 versus 10.9 ± 5.5, p<0.001) and texture (15.8 ± 7.0 versus 10.3 ± 5.0, p<0.01) were significantly higher in SVF-enriched group than in control group at 6 months postoperation. During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
CONCLUSIONS


Our results demonstrated the positive outcomes of autologous SVF-assisted fat graft in improving facial skin quality and its promising application potential in clinical settings. This study is registered at www. ClinicalTrials.gov, number NCT02923219.",2020,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
",['Fifty patients'],"['autologous SVF-assisted fat graft', 'Cell-assisted lipotransfer (CAL', 'Autologous fat graft assisted by stromal vascular fraction', 'stromal vascular fraction (SVF)-assisted fat graft and a control group (n\u202f=\u202f25) that underwent fat graft only']","['VISIA values of wrinkles', 'survival rate of SVF-enriched fat grafts', 'Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins', 'skin quality', 'cell viability', 'facial skin quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032712', 'cui_str': 'Porphyrin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",50.0,0.137992,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
","[{'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: zaj165@126.com.'}, {'ForeName': 'Peisheng', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: 100000401006@xzhmu.edu.cn.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.010']
308,31361315,Haemodiafiltration does not lower protein-bound uraemic toxin levels compared with haemodialysis in a paediatric population.,"BACKGROUND


Haemodiafiltration (HDF) is accepted to effectively lower plasma levels of middle molecules in the long term, while data are conflicting with respect to the additive effect of convection on lowering protein-bound uraemic toxins (PBUTs). Here we compared pre-dialysis β2-microglobulin (β2M) and PBUT levels and the percentage of protein binding (%PB) in children on post-dilution HDF versus conventional high- (hf) or low-flux (lf) haemodialysis (HD) over 12 months of treatment.
METHODS


In a prospective multicentre, non-randomized parallel-arm intervention study, pre-dialysis levels of six PBUTs and β2M were measured in children (5-20 years) on post-HDF (n = 37), hf-HD (n = 42) and lf-HD (n = 18) at baseline and after 12 months. Analysis of variance was used to compare levels and %PB in post-HDF versus conventional hf-HD and lf-HD cross-sectionally at 12 months and longitudinal from baseline to 12 months.
RESULTS


For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups. Children treated with post-HDF had lower pre-dialysis β2M levels [median 23.2 (21.5; 26.6) mg/dL] after 12 months versus children on hf-HD [P<0.01; 35.2 (29.3; 41.2) mg/dL] and children on lf-HD [P<0.001; 47.2 (34.3; 53.0) mg/dL]. While β2M levels remained steady in the hf-HD and lf-HD group, a decrease in β2M was demonstrated for children on post-HDF (P<0.01).
CONCLUSIONS


While post-HDF successfully decreased β2M, no additive effect on PBUT over 12 months of treatment was found. PBUT removal is complex and hampered by several factors. In children, these factors might be different from adults and should be explored in future research.",2020,"For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups.","['children (5-20\u2009years) on post-HDF (n\u2009=\u200937), hf-HD (n\u2009=\u200942) and lf-HD (n\u2009=\u200918) at baseline and after 12\u2009months']",['conventional high- (hf) or low-flux (lf) haemodialysis (HD'],"['pre-dialysis β2M levels', 'β2M', 'total and free plasma levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.0290474,"For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups.","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Snauwaert', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Van Biesen', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Raes', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Glorieux', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vande Walle', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Roels', 'Affiliation': 'Department of Data Analysis, Faculty of Psychology and Pedagogy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Vanholder', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Varvara', 'Initials': 'V', 'LastName': 'Askiti', 'Affiliation': ""A & P Kyriakou Children's Hospital, Athens, Greece.""}, {'ForeName': 'Karolis', 'Initials': 'K', 'LastName': 'Azukaitis', 'Affiliation': 'Clinic of Pediatrics, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bayazit', 'Affiliation': 'Department of Pediatric Nephrology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Canpolat', 'Affiliation': 'Department of Pediatric Nephrology, Istanbul University Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Fischbach', 'Affiliation': ""Children's Dialysis Center, Strasbourg, France.""}, {'ForeName': 'Krid', 'Initials': 'K', 'LastName': 'Saoussen', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Mieczyslaw', 'Initials': 'M', 'LastName': 'Litwin', 'Affiliation': ""Department of Nephrology, Kidney Transplantation and Hypertension, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Obrycki', 'Affiliation': ""Department of Nephrology, Kidney Transplantation and Hypertension, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Paglialonga', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ranchin', 'Affiliation': 'Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Samaille', 'Affiliation': 'Nephrologie pédiatrique, Hôpital Jeanne de Flandre, CHU de Lille, Lille, France.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schaefer', 'Affiliation': 'Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany.'}, {'ForeName': 'Claus Peter', 'Initials': 'CP', 'LastName': 'Schmitt', 'Affiliation': 'Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany.'}, {'ForeName': 'Brankica', 'Initials': 'B', 'LastName': 'Spasojevic', 'Affiliation': ""University Children's Hospital, Belgrade, Serbia.""}, {'ForeName': 'Constantinos J', 'Initials': 'CJ', 'LastName': 'Stefanidis', 'Affiliation': ""A & P Kyriakou Children's Hospital, Athens, Greece.""}, {'ForeName': 'Rukshana', 'Initials': 'R', 'LastName': 'Shroff', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Eloot', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz132']
309,31674644,Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis.,"CONTEXT


The ACTIVE study demonstrated the antifracture efficacy of abaloparatide in postmenopausal women with osteoporosis. ACTIVExtend demonstrated sustained fracture risk reduction with alendronate in abaloparatide-treated participants from ACTIVE. A direct comparison of the efficacy of abaloparatide and antiresorptive therapies has not been performed.
OBJECTIVE


The objective of this analysis is to compare the antifracture efficacy of abaloparatide in ACTIVE with that of alendronate in ACTIVExtend.
DESIGN


In this post hoc analysis, the rate of new vertebral fractures for women in ACTIVExtend (N = 1139) was calculated based on baseline and endpoint radiographs for placebo or abaloparatide in ACTIVE and alendronate in ACTIVExtend. Vertebral fracture rates between abaloparatide and alendronate were compared in a Poisson regression model. Fracture rates for nonvertebral and clinical fractures were compared based on a Poisson model during 18 months of abaloparatide or placebo treatment in ACTIVE and 18 months of alendronate treatment in ACTIVExtend.
RESULTS


The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction 71%; P = .027). Although the comparisons did not meet statistical significance, after switching from placebo (ACTIVE) to alendronate (ACTIVExtend), the rate of new vertebral fractures decreased from 2.49 to 1.66 fractures per 100 patient-years, and after switching from abaloparatide to alendronate from 0.47 to 0.19 fractures per 100 patient-years. The rates of nonvertebral fractures and clinical fractures were not significantly different.
CONCLUSION


Initial treatment with abaloparatide may result in greater vertebral fracture reduction compared with alendronate in postmenopausal women with osteoporosis.",2020,The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction [RRR] 71%; P=0.027).,"['Postmenopausal Women With Osteoporosis', 'postmenopausal women with osteoporosis']","['abaloparatide', 'abaloparatide and alendronate', 'Abaloparatide Versus Alendronate', 'placebo', 'alendronate', 'abaloparatide and antiresorptive therapies']","['rate of nonvertebral fractures and clinical fractures', 'rate of new vertebral fractures', 'vertebral fracture rate', 'sustained fracture risk reduction', 'Fracture rates', 'Vertebral fracture rates', 'vertebral fracture reduction', 'Fracture Risk Reduction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0384939,The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction [RRR] 71%; P=0.027).,"[{'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Endocrinology Unit, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Bockman', 'Affiliation': 'Joan and Sanford Weill Medical College of Cornell University, Hospital for Special Surgery, New York, NY, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz162']
310,31165754,Effects of system response delays on elderly humans' cognitive performance in a virtual training scenario.,"Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality. Studies that systematically inspect effects on cognitive performance are still lacking, and effects of individual characteristics are also often neglected. Building on benefits of cognitive training for decelerating cognitive decline, this Wizard-of-Oz study addresses both issues by testing 62 elderly participants in a dialogue-based memory training with a virtual agent. Participants acquired the method of loci with fading instructional guidance and applied it afterward to memorizing and recalling lists of German nouns. System response delays were randomly assigned, and training performance was included as potential mediator. Participants' age, gender, and subscales of affinity for technology (enthusiasm, competence, positive and negative perception of technology) were inspected as potential moderators. The results indicated positive effects on recall performance with higher training performance, female gender, and less negative perception of technology. Additionally, memory retention and facets of affinity for technology moderated increasing system response delays. Participants also provided higher ratings in perceived system quality with higher enthusiasm for technology but reported increasing frustration with a more positive perception of technology. Potential explanations and implications for the design of spoken dialogue systems are discussed.",2019,Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality.,"[""elderly humans' cognitive performance in a virtual training scenario"", '62 elderly participants in a dialogue-based memory training with a virtual agent']",['cognitive training'],['recall performance'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]",[],62.0,0.0196474,Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wirzberger', 'Affiliation': 'Max Planck Research Group ""Rationality Enhancement"", Max Planck Institute for Intelligent Systems, Max-Planck-Ring 4, 72076, Tübingen, Germany. maria.wirzberger@tuebingen.mpg.de.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Computer Engineering, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Georgi', 'Affiliation': 'Information Science, Faculty of Languages, Literature and Culture, University of Regensburg, Universitätsstraße 31, 93053, Regensburg, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Hardt', 'Affiliation': 'Computer Engineering, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Brunnett', 'Affiliation': 'Computer Graphics and Visualization, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Günter Daniel', 'Initials': 'GD', 'LastName': 'Rey', 'Affiliation': 'Psychology of Learning with Digital Media, Faculty of Humanities, TU Chemnitz, Straße der Nationen 12, 09111, Chemnitz, Germany.'}]",Scientific reports,['10.1038/s41598-019-44718-x']
311,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
312,32259823,The Effect of a Thixotropic Nasal Gel on Nasal Symptoms and Inflammatory Biomarkers in Seasonal Allergic Rhinitis.,"BACKGROUND


Drug-free viscous nasal applications have been shown to reduce nasal symptoms in individuals with seasonal allergic rhinitis (SAR). Nascum®-Plus (NP), a commercially available thixotropic gel, has been designed to reduce dryness and soreness of the nasal mucosa and prevent the absorption of small particles.
OBJECTIVES


The aim of this study was to assess the efficacy of single-dose NP in treating nasal symptoms and secretion during challenge in an allergen challenge chamber (ACC). Furthermore, the effect of this treatment on biomarkers and immune cells of the allergic cascade were measured.
METHODS


This open-label, cross-over, sequence-randomized, monocentric trial randomized 18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart. On Day 1, 9 subjects were challenged for 4 h with treatment, the other 9 without treatment, and vice versa on Day 22. Nasal lavage fluid and nasal filter eluate samples were obtained pre, 2, and 18 h post challenge in the ACC.
RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed. The treatment was safe and well-tolerated.
CONCLUSIONS


The physical barrier built by NP nasal gel can be safely applied in patients with allergic rhinitis. It reduces allergic nasal symptoms and secretion, but application of a single dose does not affect local inflammatory biomarkers.",2020,"RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","['patients with allergic rhinitis', 'individuals with seasonal allergic rhinitis (SAR', '18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart', 'Seasonal Allergic Rhinitis']","['single-dose NP', 'Nascum®-Plus (NP', 'Thixotropic Nasal Gel']","['biomarkers and immune cells', 'allergic nasal symptoms and secretion', 'safe and well-tolerated', 'total nasal symptom score', 'Nasal Symptoms and Inflammatory Biomarkers', 'minimized nasal secretion', 'nasal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0440327', 'cui_str': 'Orchard grass pollen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0991526', 'cui_str': 'Nasal gel'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",18.0,0.0451303,"RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Struß', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany, jens.hohlfeld@item.fraunhofer.de.'}]",International archives of allergy and immunology,['10.1159/000506129']
313,31689007,"Dietary Weight Loss, Exercise, and Inflammation in Older Adults with Overweight or Obesity and Cardiometabolic Disease.","OBJECTIVE


This study aimed to examine exercise modality during weight loss on change in inflammation among older adults with overweight or obesity and cardiometabolic disease.
METHODS


A total of 222 older adults with a mean (SD) age of 66.9 (4.7) years and a mean (SD) BMI of 33.5 (3.5) kg/m 2  were randomized to weight loss (WL; n = 68), WL plus aerobic training (WL + AT; n = 79), or WL plus resistance training (WL + RT; n = 75) for 18 months. C-reactive protein (CRP) and interleukin-6 were measured at baseline, 6 months, and 18 months.
RESULTS


All groups lost significant weight from baseline to 18 months, with average adjusted changes of -5.5% for WL, -9.0% for WL + AT, and -10.1% for WL + RT. WL + RT and WL + AT lost significantly more weight than WL (P < 0.05). At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004). The only difference in interleukin-6 was that at 18 months, WL + RT was lower than WL + AT (2.32 pg/mL vs. 2.75 pg/mL; P = 0.03).
CONCLUSIONS


The addition of RT during WL was more effective at reducing levels of CRP than WL. Although results were in the expected direction, there was no difference in CRP between WL and WL + AT.",2019,"At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004).","['222 older adults with a mean (SD) age of 66.9 (4.7) years and a mean (SD) BMI of 33.5 (3.5) kg/m 2  were randomized to weight loss (WL; n\u2009=\u200968', 'Older Adults with Overweight or Obesity and Cardiometabolic Disease', 'older adults with overweight or obesity and cardiometabolic disease']","['WL plus aerobic training (WL\u2009+\u2009AT; n\u2009=\u200979), or WL plus resistance training (WL\u2009+\u2009RT', 'exercise modality']","['C-reactive protein (CRP) and interleukin-6', 'CRP', 'interleukin-6', 'CRP values', 'Dietary Weight Loss, Exercise, and Inflammation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",222.0,0.0556616,"At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004).","[{'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Marsh', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22600']
314,31821491,Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial.,"BACKGROUND


There has been little research on strategies for prevention of peritoneal dialysis (PD)-related peritonitis. We explored whether regular retraining on bag exchanges (via two methods: technique inspection and oral education) every other month could help reduce the risk of peritonitis in PD patients through a randomized controlled trial (RCT).
METHOD


This is an RCT conducted at Peking University First Hospital. A total of 150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018. Patients were randomly assigned 1:1:1 to receive retraining on bag exchange via technique inspection, oral education or usual care. The primary outcome was time to the first peritonitis episode. Secondary outcomes were time to organism-specific peritonitis, transfer to haemodialysis and all-cause death.
RESULTS


Patients in the technique inspection group, oral education group and usual care group (n = 50 for each group) were followed up for 47.5 ± 22.9 months. Time to first peritonitis was comparable between the groups. The technique inspection group showed a lower risk of first non-enteric peritonitis than the usual care group, while the oral education group did not show a significant benefit. The incidence of first non-enteric peritonitis in the usual care group (0.07/patient-year) was significantly higher than that in the technique inspection group (0.02/patient-year; P < 0.01) but was comparable with that in the oral education group (0.06/patient-year). Transfer to haemodialysis and all-cause mortality were not significantly different between the groups.
CONCLUSIONS


Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01621997).",2020,"Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
","['150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018', 'Patients in the technique inspection group, oral education group and usual care group (n\u2009']","['retraining on bag exchange via technique inspection, oral education or usual care', 'peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education', 'regular retraining on bag exchanges (via two methods: technique inspection and oral education']","['time to organism-specific peritonitis, transfer to haemodialysis and all-cause death', 'lower risk of first non-enteric peritonitis', 'time to the first peritonitis episode', 'Time to first peritonitis', 'incidence of first non-enteric peritonitis', 'risk of peritonitis', 'Transfer to haemodialysis and all-cause mortality', 'risk of all-cause peritonitis', 'risk of non-enteric PD-related peritonitis']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",150.0,0.113217,"Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Zhikai', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz238']
315,30882553,Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age.,"OBJECTIVES


To evaluate the efficacy of an innovative, self-administered, electronic Screening and Brief Intervention (e-SBI) in English and Spanish, ""DrinkWise,"" for reducing drinking among nonpregnant women of childbearing age.
METHODS


A parallel design, phase 1 trial included 185 nonpregnant women reporting risky drinking (8 or more drinks in a week or 3 or more drinks in a day) who were recruited from 2 publicly funded Nutritional Assistance for Women, Infants and Children (WIC) program sites in the United States from 2016 to 2017. Participants were 18 to 44 years in age, 75% of Hispanic ethnicity, 44% Spanish speakers, 30% had not completed high school, and 15% were currently breastfeeding. Participants were randomized to receive (intervention condition, n = 99) or not receive (control condition, no intervention, n = 86) DrinkWise and followed at 3 and 6 months.
RESULTS


Women receiving DrinkWise had greater reductions in the odds of self-reported weekly alcohol use (odds ratio [OR] = 0.22, SE = 0.12, P < 0.01) and heavy alcohol use (OR = 0.23, SE = 0.14, P < 0.05) at 6-month follow-up than controls, with no group differences at 3-month follow-up. Compared with heavy drinking controls, heavy drinkers receiving DrinkWise showed a trend (P = 0.06) for greater reductions in drink (pour) size from 3- to 6-month follow-up.
CONCLUSIONS


DrinkWise may be efficacious in reducing drinking among low-income women of childbearing age and provides a low-cost tool for increasing access to recommended SBI among childbearing-age women. Studies should continue to build DrinkWise's evidence base.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02337361.",2019,"Compared with heavy drinking controls, heavy drinkers receiving DrinkWise showed a trend (P = 0.06) for greater reductions in drink (pour) size from 3- to 6-month follow-up.
","['Women of Childbearing Age', 'Participants were 18 to 44 years in age, 75% of Hispanic ethnicity, 44% Spanish speakers, 30% had not completed high school, and 15% were currently breastfeeding', 'childbearing-age women', '185 nonpregnant women reporting risky drinking (8 or more drinks in a week or 3 or more drinks in a day) who were recruited from 2 publicly funded Nutritional Assistance for Women, Infants and Children (WIC) program sites in the United States from 2016 to 2017', 'nonpregnant women of childbearing age']","['innovative, self-administered, electronic Screening and Brief Intervention (e-SBI', 'Innovative Electronic Screening and Brief Intervention', 'receive (intervention condition, n\u200a=\u200a99) or not receive (control condition, no intervention, n\u200a=\u200a86) DrinkWise and followed at 3 and 6 months']","['heavy alcohol use', 'drink (pour) size']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C1444661', 'cui_str': 'Not completed'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",185.0,0.047543,"Compared with heavy drinking controls, heavy drinkers receiving DrinkWise showed a trend (P = 0.06) for greater reductions in drink (pour) size from 3- to 6-month follow-up.
","[{'ForeName': 'Madhabika B', 'Initials': 'MB', 'LastName': 'Nayak', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, CA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Kaskutas', 'Affiliation': ''}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Mericle', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000518']
316,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
317,31227225,Direct Delivery of Kidney Transplant Education to Black and Low-Income Patients Receiving Dialysis: A Randomized Controlled Trial.,"RATIONALE & OBJECTIVE


Compared with others, black and low-income patients receiving dialysis are less likely to receive kidney transplantation (KT) education within dialysis centers. We examined the efficacy of 2 supplementary KT education approaches delivered directly to patients.
STUDY DESIGN


Prospective, 3-arm parallel-group, randomized, controlled trial.
SETTINGS & PARTICIPANTS


Adult, black, and white low-income patients receiving dialysis in Missouri.
INTERVENTION


Patients were randomly assigned to 1 of 3 educational conditions: (1) standard of care, usual KT education provided in dialysis centers (control); (2) Explore Transplant @ Home patient-guided, 4 modules of KT education sent directly to patients using print, video, and text messages; and (3) Explore Transplant @ Home educator-guided, the patient-guided intervention plus 4 telephonic discussions with an educator.
OUTCOMES


Primary: patient knowledge of living (LDKT) and deceased donor KT (DDKT). Secondary: informed decision making, change in attitudes in favor of LDKT and DDKT, and change in the number of new steps taken toward KT.
RESULTS


In intent-to-treat analyses, patients randomly assigned to educator- and patient-guided interventions had greater knowledge gains (1.4 point increase) than control patients (0.8 point increase; P=0.02 and P=0.01, respectively). Compared with control patients, more patients randomly assigned to educator- and patient-guided interventions were able to make informed decisions about starting KT evaluation (82% vs 91% and 95%; P=0.003), pursuing DDKT (70% vs 84% and 84%; P=0.003), and pursuing LDKT (73% vs 91% and 92%; P<0.001).
LIMITATIONS


Potential contamination because of patient-level randomization; no assessment of clinical end points.
CONCLUSIONS


Education presented directly to dialysis patients, with or without coaching by telephone, increased dialysis patients' KT knowledge and informed decision making without increasing educational burden on providers.
FUNDING SOURCE


This project was funded by the National Institutes of Health and Health Resources and Services Administration.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT02268682.",2019,"In intent-to-treat analyses, patients randomly assigned to educator- and patient-guided interventions had greater knowledge gains (1.4 point increase) than control patients (0.8 point increase; P=0.02 and P=0.01, respectively).","['Kidney Transplant Education to Black and Low-Income Patients Receiving Dialysis', 'Compared with others, black and low-income patients receiving dialysis are less likely to receive kidney transplantation (KT) education within dialysis centers', 'Adult, black, and white low-income patients receiving dialysis in Missouri']","['3 educational conditions: (1) standard of care, usual KT education provided in dialysis centers (control); (2) Explore Transplant ', 'Transplant ', 'Home educator-guided, the patient-guided intervention plus 4 telephonic discussions with an educator']","['knowledge of living (LDKT) and deceased donor KT (DDKT', 'knowledge gains']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]",,0.108472,"In intent-to-treat analyses, patients randomly assigned to educator- and patient-guided interventions had greater knowledge gains (1.4 point increase) than control patients (0.8 point increase; P=0.02 and P=0.01, respectively).","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Waterman', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles; Terasaki Research Institute, Los Angeles, CA. Electronic address: awaterman@mednet.ucla.edu.'}, {'ForeName': 'John Devin', 'Initials': 'JD', 'LastName': 'Peipert', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; Northwestern University Transplant Outcomes Research Collaborative, Comprehensive Transplant Center, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Anna-Michelle', 'Initials': 'AM', 'LastName': 'McSorley', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Goalby', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beaumont', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Peace', 'Affiliation': 'Missouri Kidney Program, University of Missouri, Columbia, MO.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.03.430']
318,31230462,Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated with disruption in social and occupational function. Transcranial magnetic stimulation (TMS) represents a novel approach to PTSD, and intermittent theta-burst stimulation (iTBS) is a new, more rapid administration protocol with data supporting efficacy in depression. The authors conducted a sham-controlled study of iTBS for PTSD.
METHODS


Fifty veterans with PTSD received 10 days of sham-controlled iTBS (1,800 pulses/day), followed by 10 unblinded sessions. Primary outcome measures included acceptability (retention rates), changes in PTSD symptoms (clinician- and self-rated), quality of life, social and occupational function, and depression, obtained at the end of 2 weeks; analysis of variance was used to compare active with sham stimulation. Secondary outcomes were evaluated 1 month after treatment, using mixed-model analyses. Resting-state functional MRI was acquired at pretreatment baseline on an eligible subset of participants (N=26) to identify response predictors.
RESULTS


Retention was high, side effects were consistent with standard TMS, and blinding was successful. At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34). One-month outcomes, which incorporated data from the unblinded phase of the study, indicated superiority of active iTBS on clinician- and self-rated PTSD symptoms (d=-0.74 and -0.63, respectively), depression (d=-0.47), and social and occupational function (d=0.93) (all significant). Neuroimaging indicated that clinical improvement was significantly predicted by stronger (greater positive) connectivity within the default mode network and by anticorrelated (greater negative) cross-network connectivity.
CONCLUSIONS


iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for further investigation of optimal iTBS time course and duration. Consistent with previous neuroimaging studies of TMS, default mode network connectivity played an important role in response prediction.",2019,"At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34).","['Posttraumatic Stress Disorder', 'Fifty veterans with PTSD received 10 days of', 'Posttraumatic stress disorder (PTSD']","['iTBS', 'Transcranial magnetic stimulation (TMS', 'sham-controlled iTBS', 'Theta-Burst Transcranial Magnetic Stimulation']","['superiority of active iTBS on clinician- and self-rated PTSD symptoms', 'depression (d=-0.47), and social and occupational function', 'improved social and occupational function', 'acceptability (retention rates), changes in PTSD symptoms (clinician- and self-rated), quality of life, social and occupational function, and depression, obtained at the end of 2 weeks; analysis of variance', 'self-reported PTSD symptoms']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0002780', 'cui_str': 'ANOVA'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.0716431,"At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34).","[{'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Larson', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'M Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': ""van 't Wout-Frank"", 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.18101160']
319,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
320,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
321,31582360,"Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial.","BACKGROUND


Infection with influenza virus causes substantial morbidity and mortality globally, although antiviral treatments are available. Previous studies have suggested that anti-influenza immune plasma could be beneficial as treatment, but they were not designed as randomised, blinded, placebo-controlled trials. Therefore, we aimed to prospectively evaluate the clinical efficacy of high-titre immune plasma compared with standard low-titre plasma to improve outcomes in patients with severe influenza A infection.
METHODS


We did this randomised, double-blind, phase 3 trial at 41 US medical centres to assess the efficacy of high-titre anti-influenza plasma (haemagglutination inhibition antibody titre ≥1:80) compared with low-titre plasma (≤1:10). Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible. Patients were randomly assigned (2:1) using an interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group), and were followed up for 28 days from randomisation. High-titre and low-titre plasma had the same appearance. Randomisation was stratified by severity (in intensive care unit, not in intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen) and age (<18 years and ≥18 years). All participants, site staff, and the study team were masked to treatment allocation until after the final database lock. The primary endpoint was clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities) analysed in a proportional odds model (an odds ratio [OR] >1 indicates improvement in clinical status across all categories for the high-titre vs the low-titre group). The primary analysis was done in the intention-to-treat population, excluding two participants who did not receive plasma. This trial is registered with ClinicalTrials.gov, NCT02572817.
FINDINGS


Participants were recruited between Jan 26, 2016, and April 19, 2018. Of 200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48). One participant from each group did not receive plasma. At baseline, 60 (43%) of 138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen. 93% of planned plasma infusions were completed. The study was terminated in July, 2018, when independent efficacy analysis showed low conditional power to detect an effect of high-titre plasma even if full accrual (150 participants) was achieved. The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54). 47 (34%) of 138 participants experienced 88 serious adverse events: 32 (35%) with 60 events in the high-titre group and 15 (32%) with 28 events in the low-titre group. The most common serious adverse events were acute respiratory distress syndrome (ARDS; four [4%] vs two [4%]), allergic transfusion reactions (two [2%] vs two [4%]), and respiratory distress (three [3%] vs none). 65 (47%) participants experienced 183 adverse events: 42 (46%) with 126 events in the high-titre group and 23 (49%) with 57 events in the low-titre group. The most common adverse events were anaemia (four [3%] vs two [4%]) and ARDS (four [3%] vs three [5%]). Ten patients died during the study (six [7%] in the high-titre group vs four [9%] in the low-titre group, p=0·73). The most common cause of death was worsening of acute respiratory distress syndrome (two [2%] vs two [4%] patients).
INTERPRETATION


High-titre anti-influenza plasma conferred no significant benefit over non-immune plasma. Although our study did not have the precision to rule out a small, clinically relevant effect, the benefit is insufficient to justify the use of immune plasma for treating patients with severe influenza A.
FUNDING


National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Bethesda, MD, USA).",2019,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","['patients with severe influenza A', '200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48', 'patients with severe influenza A infection', '138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen', 'Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible', 'Participants were recruited between Jan 26, 2016, and April 19, 2018']","['interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group', 'intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen', 'Anti-influenza immune plasma', 'standard low-titre plasma']","['anaemia', 'respiratory distress', 'ARDS', 'acute respiratory distress syndrome', 'clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities', 'allergic transfusion reactions', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1283787', 'cui_str': 'Allergic transfusion reaction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.445549,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: jbeigel@niaid.nih.gov.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Aga', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie-Turenne', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josalyn', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tebas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Clark', 'Affiliation': 'Beaumont Hospital-Royal Oak, Royal Oak, MI, USA.'}, {'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Metcalf', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ozment', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kanakatte', 'Initials': 'K', 'LastName': 'Raviprakash', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chorley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30199-7']
322,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
323,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
324,32260470,Bariatric Surgery Improves HDL Function Examined by ApoA1 Exchange Rate and Cholesterol Efflux Capacity in Patients with Obesity and Type 2 Diabetes.,"Bariatric surgery improves glycemic control better than medical therapy; however, the effect of bariatric surgery on HDL function is not well characterized. Serum samples were available at baseline, 1-, and 5-years post procedures, for 90 patients with obesity and type 2 diabetes who were randomized to intensive medical therapy ( n  = 20), Roux-en-Y gastric bypass (RYGB,  n  = 37), or sleeve gastrectomy (SG,  n  = 33) as part of the STAMPEDE clinical trial. We examined serum HDL function by two independent assays, apolipoprotein A-1 exchange rate (AER) and cholesterol efflux capacity (CEC). Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups. CEC was divided into ABCA1-dependent and independent fractions, and the later was correlated with AER. ABCA1-independent CEC increased significantly only at 5 years in both surgical groups, but did not significantly change in the medical therapy group. There was no significant change in ABCA1-dependent CEC in any group. The increase in AER, but not ABCA1-independent CEC, was correlated with the reduction in body mass index and glycated hemoglobin levels among all subjects at 5 years, indicating that AER as a measure of HDL function would be a better reflection of therapy versus CEC.",2020,"Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups.","['90 patients with obesity and type 2 diabetes', 'Patients with Obesity and Type 2 Diabetes']","['CEC', 'Roux-en-Y gastric bypass (RYGB,  n  = 37), or sleeve gastrectomy (SG', 'Bariatric Surgery', 'intensive medical therapy', 'Bariatric surgery']","['ABCA1-independent CEC', 'serum HDL function', 'ABCA1-dependent CEC', 'apolipoprotein A-1 exchange rate (AER) and cholesterol efflux capacity (CEC', 'body mass index and glycated hemoglobin levels', 'HDL Function Examined by ApoA1 Exchange Rate and Cholesterol Efflux Capacity', 'HDL function', 'AER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C1112870', 'cui_str': 'Drug aerosol'}]",90.0,0.0127405,"Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups.","[{'ForeName': 'Shuhui Wang', 'Initials': 'SW', 'LastName': 'Lorkowski', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brubaker', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Endocrinology Institute, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Schauer', 'Affiliation': 'Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}]",Biomolecules,['10.3390/biom10040551']
325,31674641,Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.,"CONTEXT


In the Denosumab and High-Dose Teriparatide Administration (DATA-HD) study, we reported that 15 months of combined high-dose (HD) teriparatide and denosumab increased mean areal bone mineral density (aBMD) at the hip and spine more than combined denosumab and standard-dose (SD) teriparatide.
OBJECTIVE


In the current analysis, we compare the individual rates of aBMD response between the treatment groups.
DESIGN


Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration). The proportion of participants in the SD and HD groups experiencing total hip, femoral neck, and lumbar spine aBMD gains of >3%, >6%, and >9% were compared.
PARTICIPANTS


Postmenopausal women with osteoporosis completing all study visits (n = 60).
MAIN OUTCOME MEASURE(S)


aBMD (dual x-ray absorptiometry).
RESULTS


At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044). At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).
CONCLUSION


Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD. These results suggest that this approach may provide unique benefits in the treatment of postmenopausal osteoporosis.",2020,"Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD.","['postmenopausal women', 'Postmenopausal women with osteoporosis completing all study visits (n = 60']","['combined high-dose (HD) teriparatide and denosumab', 'teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0-9, overlapped with denosumab 60-mg', 'denosumab in combination with\xa0standard or high-dose teriparatide']","['mean areal bone mineral density (aBMD', 'BMD', 'clinically meaningful and rapid gains in hip and spine aBMD', 'femoral neck', 'total hip, femoral neck, and lumbar spine aBMD gains', 'response rates', 'aBMD (dual x-ray absorptiometry', 'aBMD response', 'Bone mineral density response']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",,0.0653879,"Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD.","[{'ForeName': 'Sabashini K', 'Initials': 'SK', 'LastName': 'Ramchand', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz163']
326,32252548,Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial.,"BACKGROUND


The REDUAL PCI trial (Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting) demonstrated that, in patients with atrial fibrillation following percutaneous coronary intervention, bleeding risk was lower with dabigatran plus clopidogrel or ticagrelor (dual therapy) than warfarin plus clopidogrel or ticagrelor and aspirin (triple therapy). Dual therapy was noninferior for risk of thromboembolic events. Whether these results apply equally to patients at higher risk of ischemic events due to lesion complexity or clinical risk factors is unclear.
METHODS


The primary end point was time to first major or clinically relevant nonmajor bleeding event. The composite efficacy end point was death, thromboembolic event, or unplanned revascularization. Our prespecified subgroup analysis categorized patients by presence of procedural complexity and/or clinical complexity factors at baseline. A modified dual antiplatelet therapy score categorized patients according to degree of clinical risk.
RESULTS


Of 2725 patients, 43.1% had clinical complexity factors alone, 9.9% procedural factors alone, 10.0% both, and 37.0% neither. Risk of the primary bleeding end point was lower in both dabigatran dual therapy groups than warfarin triple therapy groups, regardless of procedural and/or clinical lesion complexity (interaction  P  values: 0.90 and 0.37, respectively). Importantly, a similar risk of the efficacy end point was observed between dabigatran dual and warfarin triple therapy, regardless of the presence of clinical or procedural complexity factors (interaction  P  values: 0.67 and 0.54, dabigatran 110 and 150 mg dual therapy, respectively). Similar benefit was seen for each dose of dabigatran dual therapy for bleeding events regardless of dual antiplatelet therapy score (interaction  P  values: 0.53 and 0.54, respectively), with similar risk of thromboembolic events (interaction  P  values: 0.20 and 0.08, respectively).
CONCLUSIONS


In patients with atrial fibrillation undergoing percutaneous coronary intervention, dabigatran 110 and 150 mg dual therapy reduced bleeding risk compared with warfarin triple therapy, with a similar risk of thromboembolic outcomes, irrespective of procedural and/or clinical complexity and modified dual antiplatelet therapy score. Registration: URL: https://clinicaltrials.gov/; Unique identifier: NCT02164864.",2020,"Risk of the primary bleeding end point was lower in both dabigatran dual therapy groups than warfarin triple therapy groups, regardless of procedural and/or clinical lesion complexity (interaction  P  values: 0.90 and 0.37, respectively).","['Atrial Fibrillation', 'patients with atrial fibrillation undergoing', 'Patients With AF']","['warfarin plus clopidogrel or ticagrelor and aspirin (triple therapy', 'Percutaneous Coronary Intervention', 'warfarin triple therapy', 'Dabigatran vs Triple Therapy With Warfarin', 'percutaneous coronary intervention, dabigatran 110 and 150 mg dual therapy', 'Dabigatran Dual Therapy Versus Warfarin Triple Therapy', 'dabigatran plus clopidogrel or ticagrelor']","['death, thromboembolic event, or unplanned revascularization', 'similar risk of thromboembolic events', 'time to first major or clinically relevant nonmajor bleeding event', 'bleeding risk', 'procedural and/or clinical lesion complexity']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",2725.0,0.0428521,"Risk of the primary bleeding end point was lower in both dabigatran dual therapy groups than warfarin triple therapy groups, regardless of procedural and/or clinical lesion complexity (interaction  P  values: 0.90 and 0.37, respectively).","[{'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Berry', 'Affiliation': 'Mid-Atlantic Permanente Medical Group, McLean, VA (N.C.B.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic, Minneapolis, MN (L.M.).'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148 and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B., C.P.C.).""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany (S.H.H.).'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany (M.N.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Japan (T.K.).'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, United Kingdom (G.Y.H.L.).'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Sweden (J.O.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.t.B.).'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B., C.P.C.).""}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008349']
327,30586008,Haptoglobin 2 Allele is Associated With Histologic Response to Vitamin E in Subjects With Nonalcoholic Steatohepatitis.,"BACKGROUND


Haptoglobin (Hp) genotype has been linked to oxidative stress and cardiovascular outcomes in response to vitamin E (VitE) among patients with diabetes mellitus. Its effect on histologic response to VitE in nonalcoholic steatohepatitis (NASH) is unknown.
GOALS


Our objective was to determine if Hp genotype associates with response to VitE in patients with NASH.
STUDY


A post hoc analysis of 228 patients receiving VitE or placebo in 2 clinical trials was performed. Regression analysis was used to assess the effect of VitE versus placebo, by Hp genotype (1-1, 2-1, or 2-2), on histologic features and laboratory markers of nonalcoholic fatty liver disease, comparing baseline to end of treatment values. An interaction term was included in the regression models to assess differential treatment effect across Hp genotype.
RESULTS


Hp 2-2 patients treated with VitE versus placebo showed significant histologic improvement (51% vs. 20%; OR=4.2; P=0.006), resolution of steatohepatitis (44% vs. 12%; OR=6.2; P=0.009), decrease in nonalcoholic fatty liver disease Activity Score (NAS) (-2.2 vs. -0.6; P=0.001), and decrease in liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase. Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes. Hp 1-1 patients showed no significant improvement in histology or liver enzymes. VitE had no effect on fibrosis stage in any group. Regression analysis showed incremental benefit of having Hp 2-2 or 2-1 versus 1-1 for all liver enzyme.
CONCLUSIONS


Hp 2 allele is associated with greater histologic and biological improvement in NASH with VitE treatment compared with the Hp 1 allele.",2019,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","['patients with NASH', '228 patients receiving VitE or', 'patients with diabetes mellitus', 'Subjects With Nonalcoholic Steatohepatitis']","['vitamin E (VitE', 'VitE versus placebo', 'Vitamin E', 'placebo']","['resolution of steatohepatitis, NAS and liver enzymes', 'nonalcoholic fatty liver disease Activity Score (NAS', 'histology or liver enzymes', 'fibrosis stage', 'histologic improvement', 'resolution of steatohepatitis', 'liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",228.0,0.342091,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","[{'ForeName': 'Bubu A', 'Initials': 'BA', 'LastName': 'Banini', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Cazanave', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Amon', 'Initials': 'A', 'LastName': 'Asgharpour', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vincent', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Faridoddin', 'Initials': 'F', 'LastName': 'Mirshahi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Le', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Contos', 'Affiliation': 'Division of Surgical Pathology, Department of Pathology, VCU School of Medicine, Richmond, VA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Naga P', 'Initials': 'NP', 'LastName': 'Chalasani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Indiana Fatty Liver Disease Research Group, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Health System.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001142']
328,31537089,Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial.,"OBJECTIVE


The authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide a reduction in suicidal ideation superior to placebo.
METHODS


Reducing Suicidal Ideation Through Insomnia Treatment was an 8-week three-site double-blind placebo-controlled parallel-group randomized controlled trial of zolpidem-CR hypnotic therapy compared with placebo, in conjunction with an open-label selective serotonin reuptake inhibitor. Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation. Suicidal ideation was the main outcome, measured first by the Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS).
RESULTS


A total of 103 participants were randomly assigned to receive zolpidem-CR (N=51) or placebo (N=52) (64 women and 39 men; mean age=40.5 years). Zolpidem-CR had a robust anti-insomnia effect, especially in patients with the most severe insomnia symptoms. No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56, SE=0.83, 95% CI=-2.19, 1.08), but the reduction in scores was significantly positively related to improvement in insomnia after accounting for the effect of other depression symptoms. The C-SSRS indicated that zolpidem-CR had a significant treatment effect (least squares mean estimate=-0.26, SE=0.12, 95% CI=-0.50, -0.02). The advantage for zolpidem-CR in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia. No deaths or suicide attempts occurred.
CONCLUSIONS


Although the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation in all depressed outpatients with insomnia, they suggest that coprescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.",2019,"No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56,","['patients with more severe insomnia', 'A total of 103 participants', 'suicidal adults with insomnia', 'Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation', 'N=52) (64 women and 39 men; mean age=40.5 years', 'patients with severe insomnia', 'patients with the most severe insomnia symptoms']","['placebo, in conjunction with an open-label selective serotonin reuptake inhibitor', 'zolpidem-CR hypnotic therapy', 'hypnotic medication', 'placebo', 'zolpidem-CR', 'Zolpidem-CR', 'zolpidem (zolpidem-CR']","['Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS', 'Scale for Suicide Ideation', 'insomnia', 'Suicidal ideation', 'suicidal ideation', 'Suicidal Ideation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",103.0,0.293314,"No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56,","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Benca', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Newman', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Case', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Rumble', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19030267']
329,31665314,Bone Mineral Density After Transitioning From Denosumab to Alendronate.,"CONTEXT


There are few studies on patients transitioning from denosumab to bisphosphonates.
OBJECTIVE


To investigate patient characteristics and changes in bone mineral density (BMD) after transitioning from denosumab to alendronate.
DESIGN


Randomized, open-label, 2-year crossover Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531).
SETTING


25 study centers in the US and Canada.
PATIENTS


Treatment-naïve postmenopausal women with BMD T-scores from -2.0 to -4.0.
INTERVENTIONS


This post hoc analysis evaluated women randomized to subcutaneous denosumab 60 mg every 6 months in year 1 followed by once-weekly oral alendronate 70 mg in year 2.
MAIN OUTCOME MEASURE


A 3% BMD threshold identified participants who lost, maintained, or gained BMD in year 2 on alendronate.
RESULTS


Of 126 participants randomized to denosumab, 115 (91%) transitioned to alendronate in year 2. BMD increased by 3% to 6% with denosumab in year 1 and by 0% to 1% with alendronate in year 2. After transitioning to alendronate, most participants maintained or increased BMD; 15.9%, 7.6%, and 21.7% lost BMD at the lumbar spine, total hip, and femoral neck, respectively. Few participants fell below their pretreatment baseline BMD value; this occurred most often in those who lost BMD in year 2. Women who lost BMD with alendronate in year 2 also showed a greater percent change in BMD with denosumab in year 1. The BMD change in year 2 was similar regardless of baseline characteristics or adherence to oral alendronate.
CONCLUSION


Alendronate can effectively maintain the BMD gains accrued after 1 year of denosumab in most patients, regardless of baseline characteristics.",2020,BMD increased by 3%-6% with denosumab in year 1 and by 0%-1% with alendronate in year 2.,"['25 study centers in the USA and Canada', 'Treatment-naïve postmenopausal women with BMD T-scores ≤-2.0 to ≥-4.0', 'subjects transitioning from denosumab to bisphosphonates', '126 subjects randomized to']","['Alendronate', 'alendronate 70 mg QW PO', 'denosumab 60 mg SC Q6M', 'alendronate', 'denosumab']","['BMD change', 'BMD', 'bone mineral density (BMD', 'BMD gains', 'Bone Mineral Density']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",126.0,0.177777,BMD increased by 3%-6% with denosumab in year 1 and by 0%-1% with alendronate in year 2.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, US.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Clark', 'Affiliation': 'Hospital Infantil de Mexico Federico Gómez and National University of Mexico-UNAM, Mexico City, Mexico.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, US.'}, {'ForeName': 'Yumie', 'Initials': 'Y', 'LastName': 'Rhee', 'Affiliation': 'Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, US.'}, {'ForeName': 'Robert Kees', 'Initials': 'RK', 'LastName': 'Stad', 'Affiliation': 'Amgen Inc., Rotkreuz, Switzerland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz095']
330,31324402,Effect of a 24-week randomized trial of an organic produce intervention on pyrethroid and organophosphate pesticide exposure among pregnant women.,"BACKGROUND


Introduction of an organic diet can significantly reduce exposure to some classes of pesticides in children and adults, but no long-term trials have been conducted.
OBJECTIVES


To assess the effect of a long-term (24-week) organic produce intervention on pesticide exposure among pregnant women.
METHODS


We recruited 20 women from the Idaho Women, Infants, and Children (WIC) program during their first trimester of pregnancy. Eligible women were nonsmokers aged 18-35 years who reported eating exclusively conventionally grown food. We randomly assigned participants to receive weekly deliveries of either organic or conventional fruits and vegetables throughout their second or third trimesters and collected weekly spot urine samples. Urine samples, which were pooled to represent monthly exposures, were analyzed for biomarkers of organophosphate (OP) and pyrethroid insecticides.
RESULTS


Food diary data demonstrated that 66% of all servings of fruits and vegetables consumed by participants in the ""organic produce"" group were organic, compared to <3% in the ""conventional produce"" group. We collected an average of 23 spot samples per participant (461 samples total), which were combined to yield 116 monthly composites. 3-Phenoxybenzoic acid (3-PBA, a non-specific biomarker of several pyrethroids) was detected in 75% of the composite samples, and 3-PBA concentrations were significantly higher in samples collected from women in the conventional produce group compared to the organic produce group (0.95 vs 0.27 μg/L, p = 0.03). Another pyrethroid biomarker, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylic acid, was detected more frequently in women in the conventional compared to the organic produce groups (16% vs 4%, p = 0.05). In contrast, we observed no statistically significant differences in detection frequency or concentrations for any of the four biomarkers of OP exposure quantified in this trial.
DISCUSSION


To our knowledge, this is the first long-term organic diet intervention study, and the first to include pregnant women. These results suggest that addition of organic produce to an individual's diet, as compared to conventional produce, significantly reduces exposure to pyrethroid insecticides.",2019,"In contrast, we observed no statistically significant differences in detection frequency or concentrations for any of the four biomarkers of OP exposure quantified in this trial.
","['20 women from the Idaho Women, Infants, and Children (WIC) program during their first trimester of pregnancy', 'pregnant women', 'Eligible women were nonsmokers aged 18-35\u202fyears who reported eating exclusively conventionally grown food']","['organic produce intervention', '3-Phenoxybenzoic acid (3-PBA', 'long-term (24-week) organic produce intervention', 'organic or conventional fruits and vegetables throughout their second or third trimesters and collected weekly spot urine samples']",['3-PBA concentrations'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020787', 'cui_str': 'Idaho'}, {'cui': 'C4277516', 'cui_str': 'WIC Program'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C2936536', 'cui_str': 'Organic Produce'}, {'cui': 'C0047689', 'cui_str': '3-PBA'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0457208', 'cui_str': 'Spot urine sample (specimen)'}]","[{'cui': 'C0047689', 'cui_str': '3-PBA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",20.0,0.0420463,"In contrast, we observed no statistically significant differences in detection frequency or concentrations for any of the four biomarkers of OP exposure quantified in this trial.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Curl', 'Affiliation': 'Department of Community and Environmental Health, Boise State University, Boise, ID, USA. Electronic address: cynthiacurl@boisestate.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Department of Community and Environmental Health, Boise State University, Boise, ID, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Penwell', 'Affiliation': 'Department of Community and Environmental Health, Boise State University, Boise, ID, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Phinney', 'Affiliation': 'Department of Community and Environmental Health, Boise State University, Boise, ID, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ospina', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",Environment international,['10.1016/j.envint.2019.104957']
331,31549178,Prasugrel effectively reduces the platelet reactivity units in patients with genetically metabolic dysfunction of cytochrome P450 2C19 who are treated with long-term dual antiplatelet therapy after undergoing drug-eluting stent implantation.,"Dual antiplatelet therapy (DAPT) with aspirin and P2Y 12  inhibitor is administered following percutaneous coronary intervention (PCI) with coronary stent implantation. Several studies have reported the effects of switching between P2Y 12  inhibitors on platelet reactivity (P2Y 12  reaction units: PRU), from acute to late phase after PCI. However, the effect of switching at very late phase is unknown. This study examined the effect on PRU in Japanese coronary heart disease patients with long-term DAPT (aspirin + clopidogrel) when switching from clopidogrel to prasugrel. Ninety-six patients were enrolled in this study. The median DAPT duration at enrollment was 1824.0 days. Twenty-three patients with PRU ≥ 208 at enrollment were randomly assigned into either continuing to receive clopidogrel (Continued Group; n = 11) or switching to prasugrel (Switched Group; n = 12). The primary endpoint was the rate of patients who achieved PRU < 208 at the end of 12 weeks of treatment, which was significantly higher in Switched Group relative to Continued Group (90.0% vs. 36.4%; P = 0.024). The secondary endpoint was the PRU at week 12 in groups subdivided according to cytochrome P450 (CYP) 2C19 genotypes. At week 12, extensive metabolizers (EM Group) had 202.3 ± 60.0 and 174.5 ± 22.3 in Continued Group and Switched Group (P = 0.591), respectively; intermediate and poor metabolizers (non-EM Group) had 229.4 ± 36.9 and 148.4 ± 48.4 in Continued Group and Switched Group (P = 0.002), respectively. The PRU for non-EM Group was significantly reduced in Switched Group. Thus, for patients with long-term DAPT (aspirin + clopidogrel) after PCI with coronary stent implantation, switching from clopidogrel to prasugrel resulted in a stable reduction in PRU, regardless of CYP2C19 polymorphism.",2020,The PRU for non-EM Group was significantly reduced in Switched Group.,"['Ninety-six patients were enrolled in this study', 'Twenty-three patients with PRU\u2009≥', 'Japanese coronary heart disease patients with long-term', '208 at enrollment', 'patients with genetically metabolic dysfunction of cytochrome P450 2C19 who are treated with long-term dual antiplatelet therapy after undergoing drug-eluting stent implantation', 'patients with long-term DAPT (aspirin\u2009+\u2009clopidogrel) after PCI with coronary stent implantation']","['Prasugrel', 'PRU', 'percutaneous coronary intervention (PCI) with coronary stent implantation', 'Dual antiplatelet therapy (DAPT) with aspirin', 'DAPT (aspirin\u2009+\u2009clopidogrel', 'clopidogrel (Continued Group; n\u2009=\u200911) or switching to prasugrel']","['rate of patients who achieved PRU', 'platelet reactivity units', 'median DAPT duration', 'PRU', 'platelet reactivity']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0010762', 'cui_str': 'Cytochrome P-450 Families'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",96.0,0.0448017,The PRU for non-EM Group was significantly reduced in Switched Group.,"[{'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Shimamatsu', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Ken-Ichiro', 'Initials': 'KI', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Katsuki', 'Affiliation': 'Division of Cardiology, Sugi Hospital, Omuta, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Shin Koga Hospital, Kurume, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Murasato', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Ajisaka', 'Affiliation': 'Division of Cardiovascular Internal Medicine, Asakura Medical Association Hospital, Asakura, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Division of Cardiovascular Internal Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tashiro', 'Affiliation': ""Division of Cardiovascular Internal Medicine, St. Mary's Hospital, Kurume, Japan.""}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hirakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Ishizaki', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishimatsu', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Kagiyama', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Fukumoto', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Kakuma', 'Affiliation': 'Biostatistics Center, Kurume University, Kurume, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahimachi, Kurume, 830-0011, Fukuoka, Japan. takueno@med.kurume-u.ac.jp.'}]",Heart and vessels,['10.1007/s00380-019-01499-7']
332,31657840,Association of a Workplace Sales Ban on Sugar-Sweetened Beverages With Employee Consumption of Sugar-Sweetened Beverages and Health.,"Importance


Reductions in sugar-sweetened beverage (SSB) intake can improve health, but are difficult for individuals to achieve on their own.
Objectives


To evaluate whether a workplace SSB sales ban was associated with SSB intake and cardiometabolic health among employees and whether a brief motivational intervention provides added benefits to the sales ban.
Design, Setting, and Participants


This before-after study and additional randomized trial conducted from July 28, 2015, to October 16, 2016, at a Northern California university and hospital assessed SSB intake, anthropometrics, and cardiometabolic biomarkers among 214 full-time English-speaking employees who were frequent SSB consumers (≥360 mL [≥12 fl oz] per day) before and 10 months after implementation of an SSB sales ban in a large workplace, with half the employees randomized to receive a brief motivational intervention targeting SSB reduction.
Interventions


The employer stopped selling SSBs in all workplace venues, and half the sample was randomized to receive a brief motivational intervention and the other half was a control group that did not receive the intervention. This intervention was modeled on standard brief motivational interventions for alcohol used in the workplace that promote health knowledge and goal setting.
Main Outcomes and Measures


Outcomes included changes in SSB intake, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), and measures of abdominal adiposity. The primary associations tested were the correlation between changes in SSB intake and changes in HOMA-IR.
Results


Among the 214 study participants, 124 (57.9%) were women, with a mean (SD) age of 41.2 (11.0) years and a baseline mean (SD) body mass index of 29.4 (6.5). They reported a mean daily intake of 1050 mL (35 fl oz) of SSBs at baseline and 540 mL (18 fl oz) at follow-up-a 510-mL (17-fl oz) (48.6%) decrease (P < .001). Reductions in SSB intake correlated with improvements in HOMA-IR (r = 0.16; P = .03). Those not randomized to receive the brief intervention reduced their SSB intake by a mean (SD) of 246.0 (84.0) mL (8.2 [2.8] fl oz), while those also receiving the brief intervention reduced SSB intake by 762.0 (84.0) mL (25.4 [2.8] fl oz). From baseline to follow-up, there were significant reductions in mean (SE) waist circumference (2.1 [2.8] cm; P < .001).
Conclusions and Relevance


This study's findings suggest that the workplace sales ban was associated with a reduction in SSB intake and a significant reduction in waist circumference among employees within 10 months. The randomized clinical trial portion of this study found that targeting those at high risk with a brief motivational intervention led to additional improvements. Workplace sales bans may offer a promising new private-sector strategy for reducing the health harms of SSB intake.
Trial Registration


ClinicalTrials.gov identifier: NCT02585336.",2019,Reductions in SSB intake correlated with improvements in HOMA-IR (r = 0.16; P = .03).,"['from July 28, 2015, to October 16, 2016, at a Northern California university and hospital assessed SSB intake, anthropometrics, and cardiometabolic biomarkers among 214 full-time English-speaking employees who were frequent SSB consumers (≥360 mL [≥12 fl oz] per day) before and 10 months after implementation of an SSB sales ban in a large workplace, with half the employees randomized to receive a', '214 study participants, 124 (57.9%) were women, with a mean (SD) age of 41.2 (11.0) years and a baseline mean (SD) body mass index of 29.4 (6.5']","['brief motivational intervention', 'motivational intervention', 'workplace SSB sales', 'brief motivational intervention targeting SSB reduction']","['mean (SE) waist circumference', 'SSB intake and changes in HOMA-IR', 'changes in SSB intake, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), and measures of abdominal adiposity', 'SSB intake', 'HOMA-IR', 'SSB intake and cardiometabolic health', 'waist circumference']","[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0560011', 'cui_str': 'fluid ounce'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",214.0,0.0717001,Reductions in SSB intake correlated with improvements in HOMA-IR (r = 0.16; P = .03).,"[{'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hartman', 'Affiliation': 'Center for Health and Community, University of California, San Francisco.'}, {'ForeName': 'Laurie M', 'Initials': 'LM', 'LastName': 'Jacobs', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Nutritional Sciences, School of Public Health, University of Michigan, Ann Arbor.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco.'}, {'ForeName': 'Leeane', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, University of California, San Francisco.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ishkanian', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, University of California, San Francisco.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wojcicki', 'Affiliation': 'Center for Health and Community, University of California, San Francisco.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, University of California, Davis.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Schmidt', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4434']
333,31665455,"GLP-1 Analog Modulates Appetite, Taste Preference, Gut Hormones, and Regional Body Fat Stores in Adults with Obesity.","PURPOSE


Obesity is associated with alterations in appetite, gastrointestinal hormone levels and excessive fat mass. We previously published a double-blind, placebo-controlled, randomized, 16-week trial on effects of once-daily glucagon-like peptide-1 (GLP-1) analog, liraglutide on weight, satiation, and gastric functions in obese volunteers. The aim of this substudy is to compare to placebo the effects of liraglutide on appetite, taste preference, regional body fat stores, and anthropometric measurements.
METHODS


Forty obese adults received standard instruction for weight management, monthly behavioral intervention utilizing motivational interviews, and 16-week treatment of once-daily liraglutide (escalated to 3 mg SQ daily). At baseline and 16 weeks, the following were measured: appetite and taste preferences rated every 30 min for 5 h after ingesting 300 mL Ensure®; maximal tolerated volume (MTV) with a nutrient drink test; fasting and postprandial bioactive GLP-1 (7-36) and peptide YY (PYY) levels; total and regional body fat with dual-energy X-ray absorptiometry, and waist and hip circumference.
RESULTS


Thirty-five participants (17 liraglutide; 18 placebo) completed the trial. Compared to placebo group, liraglutide group had significant reductions in MTV; prospective food consumption score; desire to eat something sweet, salty, savory or fatty; and an increase in perceived fullness. Postprandial plasma levels of GLP-1 decreased and PYY levels increased with liraglutide relative to baseline. Significant reductions in total body, trunk, and upper and lower body fat without reduction in lean body mass were observed.
CONCLUSION


Liraglutide 3 mg SQ modulates appetite, taste preference, gut hormones, and regional body fat stores in adults with obesity without reduction in lean body mass.",2020,"Liraglutide 3mg SQ modulates appetite, taste preference, gut hormones and regional body fat stores in adults with obesity without reduction in lean body mass.","['Adults with Obesity', 'adults with obesity without reduction in lean body mass', 'Thirty-five participants (17 liraglutide; 18', 'obese volunteers', 'Forty obese adults received']","['GLP-1 analog, liraglutide', 'Liraglutide', 'placebo', 'liraglutide', 'standard instruction for weight management, monthly behavioral intervention utilizing motivational interviews, and 16-week treatment of once daily liraglutide']","['appetite, gastrointestinal (GI) hormone levels and excessive fat mass', 'appetite, taste preference, regional body fat stores and anthropometric measurements', 'Postprandial plasma levels of GLP-1', 'weight, satiation, and gastric functions', 'tolerated volume (MTV) with a nutrient drink test; fasting and postprandial bioactive GLP-1 (7-36) and PYY levels; total and regional body fat with dual-energy x-ray absorptiometry (DXA), and waist and hip circumference', 'appetite, taste preference, gut hormones and regional body fat stores', 'total body, trunk, upper and lower body fat without reduction in lean body mass', 'GLP-1 Analog Modulates Appetite, Taste Preference, Gut Hormones and Regional Body Fat Stores', 'MTV, prospective food consumption score, desire to eat something sweet, salty, savory or fatty, and an increase in perceived fullness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1287358', 'cui_str': 'Finding of gastrointestinal hormone level (finding)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0232538', 'cui_str': 'Gastric function'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1135885', 'cui_str': 'Savory'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}]",40.0,0.184718,"Liraglutide 3mg SQ modulates appetite, taste preference, gut hormones and regional body fat stores in adults with obesity without reduction in lean body mass.","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Kadouh', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chedid', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Houssam', 'Initials': 'H', 'LastName': 'Halawi', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Duane D', 'Initials': 'DD', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychology, Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Disha', 'Initials': 'D', 'LastName': 'Khemani', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz140']
334,32249915,Intraprocedural endpoints to predict durable pulmonary vein isolation: a randomized trial of four post-ablation techniques.,"AIMS


The optimal procedural endpoint to achieve permanent pulmonary vein isolation (PVI) during ablation of atrial fibrillation (AF) remains unknown. We aimed to compare the impact of prolonged waiting periods and adenosine triphosphate (ATP) testing after PVI on long-term freedom from AF.
METHODS AND RESULTS


In total, 538 patients (median age 61 years, 62% male) undergoing first-time radiofrequency ablation for paroxysmal AF were randomized into four groups: Group 1 [PVI (no testing), n = 121], Group 2 (PVI + 30min waiting phase, n = 151), Group 3 (PVI+ATP, n = 131), and Group 4 (PVI + 30min+ATP, n = 135). The primary endpoint was freedom from AF. Repeat mapping to assess for late pulmonary vein (PV) reconnection was performed in patients who remained AF-free for >3 years (n = 46) and in those who had repeat ablation for AF recurrence (n = 82). During initial procedure, acute PV reconnection was observed in 33%, 26%, and 42% of patients in Groups 2, 3, and 4, respectively. At 36 months, no significant differences in freedom from AF recurrence were observed among all four groups (55%, 61%, 50%, and 62% for Groups 1, 2, 3, and 4, respectively; P = 0.258). Late PV reconnection was commonly observed, with a similar incidence between patients with and without AF recurrence (74% vs. 83%; P = 0.224).
CONCLUSION


Although PVI remains the cornerstone for AF ablation, intraprocedural techniques to assess for PV reconnection did not improve long-term success. Patients without AF recurrence after 3 years exhibited similarly high rates of PV reconnection as those that underwent repeat ablation for AF recurrence. The therapeutic mechanisms of AF ablation may not be solely predicated upon durable PVI.",2020,Patients without AF recurrence after 3 years exhibited similarly high rates of PV reconnection as those that underwent repeat ablation for AF recurrence.,"['538 patients (median age 61\u2009years, 62% male) undergoing first-time radiofrequency ablation for paroxysmal AF', 'patients who remained AF-free for >3\u2009years (n\u2009=\u200946) and in those who had repeat ablation for AF recurrence (n\u2009=\u200982']",['adenosine triphosphate (ATP'],"['Late PV reconnection', 'acute PV reconnection', 'freedom from AF recurrence', 'freedom from AF', 'AF recurrence', 'late pulmonary vein (PV) reconnection', 'permanent pulmonary vein isolation (PVI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]",538.0,0.0477212,Patients without AF recurrence after 3 years exhibited similarly high rates of PV reconnection as those that underwent repeat ablation for AF recurrence.,"[{'ForeName': 'Ruhong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Minglong', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Zuwen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Fengxiang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Weizhu', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Yaxun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Shiquan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz301']
335,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
336,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES


To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence.
PATIENTS AND METHODS


CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.
RESULTS


Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
CONCLUSION


Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038']
337,31822848,Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial.,"PURPOSE


To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.
METHODS


A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.
RESULTS


Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (-2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) CONCLUSIONS: The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.",2020,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","['Participants (n\u2009=\u2009133) were predominantly White/European (74%), female (90%), and ≥50 years old (60']","['Genomics ADvISER (www.genomicsadviser.com) decision aid (DA', 'DA followed by discussion with a genetic counselor, or to genetic counseling alone', 'genetic counseling alone']","['knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session', 'counseling time and improved knowledge', 'knowledge of sequencing limitations', 'knowledge of SF', 'shorter counseling time', 'anxiety', 'Decisional conflict', 'decisional conflict']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",133.0,0.134204,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Theresa H M', 'Initials': 'THM', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Muir', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0702-z']
338,32241810,Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).,"OBJECTIVE


To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants.
DESIGN


Within-trial economic evaluation alongside a multicentre, two-arm parallel group, randomised controlled trial (Speed of Increasing milk Feeds Trial).
SETTING


55 UK neonatal units from May 2013 to June 2015.
PATIENTS


Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment. Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible.
INTERVENTIONS


When clinicians were ready to start advancing feed volumes, infants were randomised to receive daily increments in feed volume of 30 mL/kg (intervention) or 18 mL/kg (control).
MAIN OUTCOME MEASURE


Cost per additional survivor without moderate to severe neurodevelopmental disability at 24 months of age corrected for prematurity.
RESULTS


Average costs per infant were slightly higher for faster feeds compared with slower feeds (mean difference £267, 95% CI -6928 to 8117). Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246). The stochastic cost-effectiveness analysis showed a likelihood of worse outcomes for faster feeds compared with slower feeds.
CONCLUSIONS


The stochastic cost-effectiveness analysis shows faster feeds are broadly equivalent on cost grounds. However, in terms of outcomes at 24 months age (corrected for prematurity), faster feeds are harmful. Faster feeds should not be recommended on either cost or effectiveness grounds to achieve the primary outcome.",2020,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[""Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment"", 'Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible', 'very preterm and very low birth weight infants', '55 UK neonatal units from May 2013 to June 2015']",['enteral feed advancement'],"['cost-effectiveness', 'survival without moderate to severe neurodevelopmental disability', 'Cost per additional survivor without moderate to severe neurodevelopmental disability']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",,0.240684,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[{'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Tahir', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University-Faculty of Medicine, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hewer', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Janet Elizabeth', 'Initials': 'JE', 'LastName': 'Berrington', 'Affiliation': 'Neonatology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Embleton', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'Neonatal Medicine, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'McCormick', 'Affiliation': 'John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Stenson', 'Affiliation': 'Neonatology, Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK t.e.roberts@bham.ac.uk.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318346']
339,31178434,Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.,"OBJECTIVE


The Restoring Insulin Secretion (RISE) Adult Medication Study compared pharmacological approaches targeted to improve β-cell function in individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration.
RESEARCH DESIGN AND METHODS


A total of 267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied. Participants were randomized to receive 12 months of metformin alone, 3 months of insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin, 12 months of liraglutide combined with metformin, or 12 months of placebo. β-Cell function was assessed using hyperglycemic clamps at baseline, 12 months (on treatment), and 15 months (3 months off treatment). The primary outcome was β-cell function at 15 months compared with baseline.
RESULTS


All three active treatments produced on-treatment reductions in weight and improvements in HbA 1c  compared with placebo; the greatest reductions were seen in the liraglutide plus metformin group. At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group. Despite on-treatment benefits, 3 months after treatment withdrawal there were no sustained improvements in β-cell function in any treatment group.
CONCLUSIONS


In adults with IGT or recently diagnosed type 2 diabetes, interventions that improved β-cell function during active treatment failed to produce persistent benefits after treatment withdrawal. These observations suggest that continued intervention may be required to alter the progressive β-cell dysfunction in IGT or early type 2 diabetes.",2019,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","['Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes', 'individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration', '267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied']","['liraglutide combined with metformin', 'placebo', 'insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin', 'metformin', 'liraglutide plus metformin']","['Restoring Insulin Secretion (RISE', 'β-cell function', 'weight and improvements in HbA 1c', 'arginine-stimulated incremental C-peptide response', 'glucose-stimulated C-peptide responses', 'β-Cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",267.0,0.0446286,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0556']
340,32249917,Relationships Between Measures of Malaria at Delivery and Adverse Birth Outcomes in a High-Transmission Area of Uganda.,"BACKGROUND


Clinical trials of interventions for preventing malaria in pregnancy often use measures of malaria at delivery as their primary outcome. Although the objective of these interventions is to improve birth outcomes, data on associations between different measures of malaria at delivery and adverse birth outcomes are limited.
METHODS


Data came from 637 Ugandan women enrolled in a randomized controlled trial of intermittent preventive treatment of malaria in pregnancy. Malaria at delivery was detected using peripheral and placental blood microscopy, placental blood loop-mediated isothermal amplification (LAMP), and placental histopathology. Multivariate analyses were used to estimate associations between measures of malaria at delivery and risks of low birth weight (LBW), small for gestational age (SGA), and preterm birth (PTB).
RESULTS


Detection of malaria parasites by microscopy or LAMP was not associated with adverse birth outcomes. Presence of malaria pigment detected by histopathology in ≥30% of high-powered fields was strongly associated with LBW (adjusted risk ratio [aRR] = 3.42, P = .02) and SGA (aRR = 4.24, P < .001) but not PTB (aRR = 0.88, P = .87).
CONCLUSIONS


A semiquantitative classification system based on histopathologically detected malaria pigment provided the best surrogate measure of adverse birth outcomes in a high-transmission setting and should be considered for use in malaria in pregnancy intervention studies.",2020,"RESULTS


Detection of malaria parasites by microscopy or LAMP was not associated with adverse birth outcomes.","['a high-transmission area of Uganda', 'Data came from 637 Ugandan women enrolled in a randomized controlled trial of intermittent preventive treatment of malaria in pregnancy']",[],"['malaria at delivery and risks of low birth weight (LBW), small-for-gestational age (SGA) and preterm birth (PTB']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}]",[],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",637.0,0.101558,"RESULTS


Detection of malaria parasites by microscopy or LAMP was not associated with adverse birth outcomes.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Razack', 'Initials': 'R', 'LastName': 'Wasswa', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Ochokoru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Arinaitwe', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Adoke', 'Initials': 'A', 'LastName': 'Yeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Atis', 'Initials': 'A', 'LastName': 'Muehlenbachs', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Chico', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa156']
341,31976519,Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men.,"BACKGROUND


11β-methyl-19-nortestosterone (11β-MNT) is a modified testosterone (T) with androgenic and progestational activity. A single oral dose of the prodrug, 11β-MNT dodecylcarbonate (11β-MNTDC), was well tolerated in healthy men.
METHODS


We conducted a randomized, double-blind study at 2 academic medical centers. 42 healthy men (18-50 years) were randomized to receive oral placebo or 11β-MNTDC, 200 or 400 mg daily, for 28 consecutive days. Primary outcome (safety and tolerability) measures were assessed twice per week. Subjects underwent serial blood sampling over 24 hours on days 1 and 28 to assess secondary outcomes: pharmacokinetics (serum drug concentrations); pharmacodynamics of 11β-MNTDC (serum sex steroids and gonadotropins); and mood and sexual function (via validated questionnaires).
RESULTS


There were no serious adverse events. No participants discontinued because of an adverse event or laboratory test abnormality. 11β-MNTDC resulted in a dose-related increase in serum 11β-MNTDC and 11β-MNT concentrations sustained over 24 hours. Administration of 11β-MNTDC resulted in a marked suppression of serum gonadotropins, T, calculated free T, estradiol, and SHBG over the treatment period (P < 0.01). Adverse effects that may be related to 11β-MNTDC included weight gain, acne, headaches, fatigue, and mild mood changes, with 5 men reporting decreased libido and 3 decreased erectile/ejaculatory function. Serum low-density lipoprotein cholesterol, weight (~2 kg), hematocrit, and hemoglobin increased and serum high-density lipoprotein cholesterol decreased in both 11β-MNTDC groups.
CONCLUSION


Daily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and T concentrations without serious adverse effects. These results warrant further evaluation of 11β-MNTDC as a potential male oral contraceptive.",2020,"CONCLUSION


Daily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and testosterone concentrations without serious adverse effects.","['two academic medical centers', 'healthy men', 'Healthy Men', '42 healthy men (18-50 years']","['11β-methyl-19-nortestosterone (11β-MNT', 'oral placebo or 11β-MNTDC', '11β-MNT dodecylcarbonate (11β-MNTDC', '11β-MNTDC']","['serum gonadotropin and testosterone concentrations', 'weight gain, acne, headaches, fatigue, and mild mood changes', 'serious adverse events', 'Serum LDL-cholesterol, weight (~2 kg), hematocrit, and hemoglobin increased and serum HDL-cholesterol', 'adverse event or laboratory test abnormality', 'Primary outcome (safety and tolerability) measures', 'libido', 'erectile/ejaculatory function', 'Serum Gonadotropins', 'serum 11β-MNTDC and 11β-MNT concentrations', 'marked suppression of serum gonadotropins, T, calculated free T, E2 and SHBG', 'secondary outcomes: pharmacokinetics (serum drug concentrations); pharmacodynamics of 11β-MNTDC (serum sex steroids and gonadotropins); and mood and sexual function (via validated questionnaires']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0027368', 'cui_str': 'Nandrolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085633', 'cui_str': 'Mood swings (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin (finding)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",42.0,0.19819,"CONCLUSION


Daily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and testosterone concentrations without serious adverse effects.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Pham', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Dart', 'Affiliation': 'Health Decisions, Durham, North Carolina.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Health Decisions, Durham, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hull', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa032']
342,31655788,Las Dos Cosas Versus Exclusive Breastfeeding: A Culturally and Linguistically Exploratory Intervention Study in Hispanic Mothers Living in Kentucky.,"INTRODUCTION


Formula supplementation among infants of breastfeeding Hispanic immigrants is common practice known as las dos cosas. The purpose of this study was to assess the feasibility, effectiveness, and acceptability of a culturally and linguistically diverse intervention to promote exclusive breastfeeding (EBF) for the first 6 months.
METHODS


A sample of 39 Hispanic pregnant women was recruited and randomly assigned to intervention (n = 20) and control groups (n = 19). The intervention included a peer counselor and professional support, and mothers were followed from pregnancy to 6 months after birth.
RESULTS


After the study, women assigned to the intervention group were over three times more likely to EBF their baby through all four postpartum assessed time points (odds ratio = 3.1, 95% confidence interval: 1.1-8.7).
DISCUSSION


This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.",2019,This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.,"['Hispanic Mothers Living in Kentucky', '39 Hispanic pregnant women', 'Hispanic mothers', 'infants of breastfeeding Hispanic immigrants']","['culturally and linguistically diverse intervention to promote exclusive breastfeeding (EBF', 'Las Dos Cosas Versus Exclusive Breastfeeding']","['EBF duration', 'feasibility, effectiveness, and acceptability']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C3650830', 'cui_str': 'Promotion of exclusive breastfeeding (procedure)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0493981,This culturally and linguistically diverse intervention contributed to increased EBF duration and decreased formula supplementation in Hispanic mothers up to 6 months postpartum.,"[{'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Linares', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cartagena', 'Affiliation': ''}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2019.07.009']
343,32236718,Effect of concomitant antiplatelet agents on clinical outcomes in the edoxaban vs warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomized trial.,"AIMS


In ENSURE-AF (NCT02072434), the oral Factor Xa inhibitor edoxaban showed similar efficacy and safety vs enoxaparin-warfarin in patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF). This ancillary analysis compares primary efficacy and safety end points for patients receiving vs not receiving concomitant antiplatelet therapy (APT) in ENSURE-AF.
METHODS


The primary efficacy end point was a composite of stroke, systemic embolic events, myocardial infarction, and cardiovascular death during 28 days on study drug after cardioversion plus 30 days of follow-up. The primary safety end point was the composite of major and clinically relevant non-major bleeding occurring between the first and the last dose of study drug.
RESULTS


Of 2199 patients enrolled, 1095 were randomized to edoxaban and 1104 to enoxaparin-warfarin. Patients receiving concomitant APT were older; more naïve to vitamin K antagonist; had lower creatinine clearance; and more likely to have history of coronary artery disease, hypertension, diabetes, or ischemic stroke/transient ischemic attack. In patients receiving vs not receiving concomitant APT, primary efficacy event rate was numerically higher (0.92% vs 0.60%, p = 0.64) and primary safety event rate was significantly higher (3.21% vs 0.92%, p = 0.0096). Stepwise logistic regression analysis identified age and APT as covariates correlated with bleeding. There was a trend toward increased bleeding risk in elderly patients receiving vs not receiving concomitant APT.
CONCLUSION


In ENSURE-AF, thromboembolic events were rare and absolute bleeding event rates were higher with concomitant APT. These findings may be relevant for AF-patients considered for dual therapy; even for a short treatment duration of 1 month.",2020,"In patients receiving vs not receiving concomitant APT, primary efficacy event rate was numerically higher (0.92% vs 0.60%, p = 0.64) and primary safety event rate was significantly higher (3.21% vs 0.92%, p = 0.0096).","['patients receiving vs not receiving concomitant antiplatelet therapy (APT', 'elderly patients receiving vs not receiving concomitant APT', 'subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF', '2199 patients enrolled, 1095 were randomized to', 'patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF']","['vitamin K antagonist', 'enoxaparin-warfarin', 'edoxaban vs warfarin', 'edoxaban']","['composite of stroke, systemic embolic events, myocardial infarction, and cardiovascular death', 'composite of major and clinically relevant non-major bleeding', 'primary safety event rate', 'creatinine clearance', 'bleeding risk', 'efficacy event rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2199.0,0.0331836,"In patients receiving vs not receiving concomitant APT, primary efficacy event rate was numerically higher (0.92% vs 0.60%, p = 0.64) and primary safety event rate was significantly higher (3.21% vs 0.92%, p = 0.0096).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, St. Vincenz Hospital Paderborn, Am Busdorf 2, 33098, Paderborn, Germany. andreas.goette@vincenz.de.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenspital, and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbuchel', 'Affiliation': 'Antwerp University and University Hospital, Cardiology, Antwerp, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01635-8']
344,28888468,Effect of visual biofeedback cycling training on gait in patients with multiple sclerosis.,"INTRODUCTION


Gait alterations are present in a high percentage of patients with multiple sclerosis (MS). They appear from early stages of the disease and can limit patients' capacity to perform basic activities of daily living, affecting their quality of life. Visual biofeedback cycling training appears to be a useful tool in treating these impairments. This study aims to evaluate the short-term effect of visual biofeedback cycling training on gait in patients with MS.
MATERIAL AND METHODS


A total of 61 patients with mild to moderate MS were randomly assigned to a control group and an intervention group. The intervention group received visual biofeedback cycling training (MOTOmed viva2 system) once per week for 3 months, and a home exercise program. The control group only received the home exercise program. Both groups were evaluated using the GAITRite® Walkway gait assessment system before the intervention, during the first month of the programme, and after the intervention.
RESULTS


In the intervention group, the analysis revealed statistically significant differences between Functional Ambulation Profile (FAP) scores before and during the intervention (P=.014), and before and after the intervention (P=.002). A statistically significant improvement was observed in step length in the intervention group between pre- and post-intervention scores (P=.001) and between first-month and post-intervention scores (P=.004).
CONCLUSIONS


Visual biofeedback cycling training improved specific gait parameters in the short term and appears to be a therapeutic option for gait retraining in patients with MS.",2020,"A statistically significant improvement was observed in step length in the intervention group between pre- and post-intervention scores (P=.001) and between first-month and post-intervention scores (P=.004).
","['patients with multiple sclerosis (MS', '61 patients with mild to moderate MS', 'patients with multiple sclerosis', 'patients with MS']","['visual biofeedback cycling training (MOTOmed viva2 system', 'visual biofeedback cycling training', 'home exercise program', 'Visual biofeedback cycling training']","['step length', 'Functional Ambulation Profile (FAP) scores', 'specific gait parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",61.0,0.0181149,"A statistically significant improvement was observed in step length in the intervention group between pre- and post-intervention scores (P=.001) and between first-month and post-intervention scores (P=.004).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hochsprung', 'Affiliation': 'Servicio de Neurología, Hospital Universitario Virgen Macarena, Sevilla, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Granja Domínguez', 'Affiliation': 'Unidad de Esclerosis Múltiple, Servicio de Neurología, Neuroinvest, Sevilla, España. Electronic address: anabelgd1792@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magni', 'Affiliation': 'Unidad de Esclerosis Múltiple, Servicio de Neurología, Fisevi, Sevilla, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Escudero Uribe', 'Affiliation': 'Unidad de Esclerosis Múltiple, Servicio de Neurología, Neuroinvest, Sevilla, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno García', 'Affiliation': 'Unidad de Esclerosis Múltiple, Servicio de Neurología, Neuroinvest, Sevilla, España.'}]","Neurologia (Barcelona, Spain)",['10.1016/j.nrl.2017.07.008']
345,31853772,Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.,"ISUM (""I'll show you mine"") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.",2020,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","['Screen Potential Sexual Partners', 'to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group', '272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU']","['ST', 'ISUM (""I\'ll show you mine', 'Rapid HIV Self-Test']",['CAI occasions'],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],,0.0544861,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ac72@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02763-7']
346,31495886,"Vitamin E absorption and kinetics in healthy women, as modulated by food and by fat, studied using 2 deuterium-labeled α-tocopherols in a 3-phase crossover design.","BACKGROUND


Determining the human vitamin E [α-tocopherol (α-T)] requirement is difficult, and novel approaches to assess α-T absorption and trafficking are needed.
OBJECTIVE


We hypothesized that the dual-isotope technique, using 2 deuterium-labeled [intravenous (IV) d6- and oral d3-] α-T, would be effective in determining α-T fractional absorption. Further, defined liquid meal (DLM) fat or fasting would modulate α-T fractional absorption and lipoprotein transport.
METHODS


A 3-phase cr ossover design was used. At 0 h, participants received IV d6-α-T and consumed d3-α-T with a 600-kcal DLM (40% or 0% fat) followed by controlled meals or by the 0% fat DLM, a 12-h fast, and then controlled meals. Blood samples and fecal samples were collected at intervals and analyzed by LC-MS. Pharmacokinetic parameters were calculated from plasma tracer concentrations and enrichments. Fractional absorption was calculated from d3- to d6-α-T areas under the curve, from a novel mathematical model, and from the balance method (oral d3-α-T minus fecal d3-α-T excreted).
RESULTS


Estimated α-T fractional absorption during the 40% fat intervention was 55% ± 3% (mean ± SEM; n = 10), which was 9% less than during the 0% fat intervention (64% ± 3%, n = 10; P < 0.02). Fasting had no apparent effect (56% ± 3%, n = 7), except it slowed plasma oral d3-α-T appearance. Both balance data and model outcomes confirmed that the DLM fat did not potentiate d3-α-T absorption. During the IV emulsion clearance, HDL rapidly acquired d6-α-T (21 ± 2 nmol/L plasma per minute). During the first 8 h postdosing, triglyceride-rich lipoproteins (TRLs) were preferentially d3-α-T enriched relative to LDL or HDL, showing the TRL precursor role.
CONCLUSIONS


Quantitatively, α-T absorption is not limited by fat absence or by fasting. However, α-T leaves the intestine by a process that is prolonged during fasting and potentiated by eating, suggesting that α-T absorption is highly dependent on chylomicron assembly processes. This trial was registered at clinicaltrials.gov as NCT00862433.",2019,"Fasting had no apparent effect (56% ± 3%, n = 7), except it slowed plasma oral d3-α-T appearance.",['healthy women'],"['human vitamin E [α-tocopherol (α-T', 'IV d6-α-T and consumed d3-α-T with a 600-kcal DLM (40% or 0% fat) followed by controlled meals or by the 0% fat DLM', 'dual-isotope technique, using 2 deuterium-labeled [intravenous (IV) d6- and oral d3-] α-T']","['α-T fractional absorption', 'Fractional absorption', 'triglyceride-rich lipoproteins (TRLs', 'Blood samples and fecal samples', 'plasma oral d3-α-T appearance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",,0.0251946,"Fasting had no apparent effect (56% ± 3%, n = 7), except it slowed plasma oral d3-α-T appearance.","[{'ForeName': 'Maret G', 'Initials': 'MG', 'LastName': 'Traber', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Leonard', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Ifechukwude', 'Initials': 'I', 'LastName': 'Ebenuwa', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Pierre-Christian', 'Initials': 'PC', 'LastName': 'Violet', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Niyyati', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Padayatty', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Courville', 'Affiliation': 'Clinical Center Nutrition Department, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Bernstein', 'Affiliation': 'Clinical Center Nutrition Department, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shamburek', 'Affiliation': 'Cardiovascular Branch, Intramural Research Program, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Head', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bobe', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Rajasekhar', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Molecular and Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz172']
347,31068654,Improvement in creativity after transcranial random noise stimulation (tRNS) over the left dorsolateral prefrontal cortex.,"Creativity has previously been shown to improve after the application of direct and alternating current transcranial stimulation over the dorsolateral prefrontal cortex (DLPFC). However, previous studies have not tested whether transcranial random noise stimulation (tRNS) was efficient for this purpose. The aim of this randomized, double-blind, placebo-controlled study was to investigate the effect of tRNS on both verbal convergent and (verbal and visual) divergent thinking during left DLPFC tRNS stimulation. Thirty healthy participants were randomly allocated to either a tRNS active group or a sham group. Each session lasted 20 min and the current was set to 1.5 mA (100-500 Hz). Participants' verbal convergent thinking was assessed with the Remote Associates Test (RAT). Verbal and visual divergent thinking were respectively measured by using the Unusual Uses and Picture Completion subtests from the Torrance Tests of Creative Thinking. Bootstrapped analysis of variance showed significant differences in the mean change scores between the active tRNS group and the sham group in RAT scores (d = 1.68); unusual uses: fluency (d = 2.29) and originality (d = 1.43); and general creativity (d = 1.45). Visual divergent thinking, in contrast, did not show any significant improvement. Our results suggested that tRNS over the left DLPFC is effective for increasing verbal divergent and convergent thinking.",2019,Bootstrapped analysis of variance showed significant differences in the mean change scores between the active tRNS group and the sham group in RAT scores (d = 1.68); unusual uses: fluency (d = 2.29) and originality (d = 1.43); and general creativity (d = 1.45).,['Thirty healthy participants'],"['transcranial random noise stimulation (tRNS', 'tRNS active group or a sham group', 'tRNS', 'placebo']","['Visual divergent thinking', 'RAT scores', 'verbal convergent thinking', 'general creativity', 'mean change scores', 'Verbal and visual divergent thinking']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0010297', 'cui_str': 'Creative Thinking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",30.0,0.171919,Bootstrapped analysis of variance showed significant differences in the mean change scores between the active tRNS group and the sham group in RAT scores (d = 1.68); unusual uses: fluency (d = 2.29) and originality (d = 1.43); and general creativity (d = 1.45).,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Basque Country, Spain. javier.pena@deusto.es.'}, {'ForeName': 'Agurne', 'Initials': 'A', 'LastName': 'Sampedro', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Basque Country, Spain.'}, {'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Ibarretxe-Bilbao', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Basque Country, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Zubiaurre-Elorza', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Basque Country, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ojeda', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Basque Country, Spain.'}]",Scientific reports,['10.1038/s41598-019-43626-4']
348,32242987,Effects of Palmaria palmata on lipid metabolism and glycemic control in participants with hypercholesterolemia in a randomized double-blind placebo-controlled trial.,"BACKGROUND


Red algae have been reported to improve lipid and glucose metabolism in rats. We investigated the effects of Palmaria palmata (P. palmata), a red alga from northern Japan, on lipid metabolism and glycemic control in participants with hypercholesterolemia.
METHODS


We conducted an 8-week, randomized, double-blind, placebo-controlled, and parallel-group comparison trial. The study enrolled Japanese participants with a serum low-density protein cholesterol (LDL-C) ≥120 mg/dL. The participants were randomly assigned to take either capsules containing P. palmata (2 g/day) or placebo capsules. The primary endpoint was the change in LDL-C from baseline to week 8 and the secondary endpoints were the changes in other lipid parameters and glycemic control.
RESULTS


Of the 104 participants completed the study protocol. There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups. However, serum triglyceride showed significantly greater improvement in women in the P. palmata group (-9.0 [-25.0, +5.0]) vs. those in the placebo group (-1.0 [-11.0, +19.0]; p = .03).
CONCLUSIONS


The present study did not show that P. palmata had significant effect on serum LDL-C nor glycemic control, but hypertriglyceridemia could be ameliorated by administration of P. palmata in women.",2020,"There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups.","['104 participants completed the study protocol', 'enrolled Japanese participants with a serum low-density protein cholesterol (LDL-C', 'participants with hypercholesterolemia', 'rats']","['placebo capsules', 'Palmaria palmata', 'Palmaria palmata (P. palmata', 'capsules containing P. palmata', 'placebo']","['serum triglyceride', 'LDL-C, body mass index, waist circumference, or glycemic control', 'lipid parameters and glycemic control', 'change in LDL-C', 'lipid and glucose metabolism', 'lipid metabolism and glycemic control', 'serum LDL-C nor glycemic control, but hypertriglyceridemia']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]",104.0,0.633972,"There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups.","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Takase', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Minori', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Toyomaki', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kusumi', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Rikako', 'Initials': 'R', 'LastName': 'Kino', 'Affiliation': 'Regional Collaboration Department, Institute for the Promotion of Business-Regional Collaboration, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Konishi', 'Affiliation': 'Hokkaido Industrial Technology Center, Hakodate, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kiso', 'Affiliation': 'Regional Collaboration Department, Institute for the Promotion of Business-Regional Collaboration, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Phytotherapy research : PTR,['10.1002/ptr.6680']
349,32243009,"Supplementation with Cynanchum wilfordii radix extract for 8 weeks lowers serum total cholesterol: A controlled, randomized, double-blind clinical trial.","This trial aimed to determine the effect of a standardized Cynanchum wilfordii Radix extract (CWE) on the lipid profiles of individuals with elevated total cholesterol (T-Chol) using a double-blind randomized placebo-controlled design. Ninety-six Korean individuals with elevated T-Chol level (200-240 mg/dL) were recruited and randomly allocated to groups that received VasH300 (300 mg CWE/day, n = 32), VasH600 (600 mg CWE/day, n = 32), or a placebo (n = 32) groups. Primary outcomes included T-Chol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters). Data were compared using a one-way analysis of variance followed by Duncan's post-hoc tests (among groups) and paired t tests (within groups). Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent. VasH300 significantly improved the lipid profiles of individuals with elevated T-Chol without any serious side effects. Daily supplementation with VasH might be an alternative strategy with which to modify cholesterol-related parameters, especially in individuals with elevated T-Chol levels.",2020,"Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent.","['individuals with elevated total cholesterol (T-Chol', 'Ninety-six Korean individuals with elevated T-Chol level (200-240\u2009mg/dL']","['placebo', 'VasH300', 'standardized Cynanchum wilfordii Radix extract (CWE', 'Cynanchum wilfordii radix extract']","['serum total cholesterol', 'Values for T-Chol and LDL-cholesterol', 'lipid profiles', 'T-Chol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331145', 'cui_str': 'Cynanchum'}, {'cui': 'C0242726', 'cui_str': 'Plant roots'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",96.0,0.58115,"Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent.","[{'ForeName': 'Seon Mi', 'Initials': 'SM', 'LastName': 'Shin', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicinem, Semyung University, Jecheon, Republic of Korea.'}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Research, Research Mentor Co. Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kwon', 'Affiliation': 'Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University, Yongin, Republic of Korea.'}, {'ForeName': 'Sung Ryul', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Department of Convergence Biomedical Science, Cardiovascular and Metabolic Disease Cencer, College of Medicine, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Se Chan', 'Initials': 'SC', 'LastName': 'Kang', 'Affiliation': 'Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University, Yongin, Republic of Korea.'}]",Phytotherapy research : PTR,['10.1002/ptr.6682']
350,32237012,Spironolactone metabolite concentrations in decompensated heart failure: insights from the ATHENA-HF trial.,"AIMS


In Aldosterone Targeted Neurohormonal Combined with Natriuresis Therapy in Heart Failure (ATHENA-HF), high-dose spironolactone (100 mg daily) did not improve efficacy endpoints over usual care [placebo or continued low-dose spironolactone (25 mg daily) in patients already receiving spironolactone] in the treatment of acute heart failure (HF). We hypothesized that low concentrations of the long-acting active metabolites of spironolactone [canrenone and 7α-thiomethylspironolactone (7α-TMS)] in the high-dose group could have contributed to these neutral results.
METHODS AND RESULTS


In patients randomized to high-dose spironolactone not previously treated with spironolactone (high-dose-naïve, n = 112), concentrations of canrenone and 7α-TMS increased at 48 and 96 h compared to baseline, and between 48 and 96 h (all P < 0.005), indicating that steady-state concentrations had not been reached by 48 h. In patients previously on low-dose, high-dose spironolactone (high-dose-previous, n = 37), concentrations of canrenone increased at 48 and 96 h compared to baseline (both P < 0.0005), with a marginal increase between 48 and 96 h (P = 0.0507). At 48 h, both high-dose groups had higher concentrations of both metabolites than the low-dose spironolactone group (P < 0.0001). Moreover, concentrations of both metabolites were higher in high-dose-previous vs. high-dose-naïve patients (P < 0.01), indicating that previous spironolactone use was significant, and that steady-state has not been reached in high-dose-naïve patients at 48 h. We found limited and inconsistent evidence of correlation between metabolite concentrations and endpoints.
CONCLUSIONS


Lower-than-anticipated concentrations of spironolactone active metabolites were observed for at least 48 h in the high-dose spironolactone group and may have contributed to the absence of pharmacological effects of spironolactone in the ATHENA-HF trial.",2020,"At 48 h, both high-dose groups had higher concentrations of both metabolites than the low-dose spironolactone group (P < 0.0001).","['decompensated heart failure', 'acute heart failure (HF']","['Spironolactone metabolite concentrations', 'spironolactone [canrenone and 7α-thiomethylspironolactone', 'spironolactone', '7α-TMS']","['concentrations of canrenone and 7α-TMS', 'concentrations of both metabolites', 'spironolactone active metabolites', 'concentrations of canrenone', 'higher concentrations of both metabolites']","[{'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006882', 'cui_str': 'Canrenone'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006882', 'cui_str': 'Canrenone'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.110662,"At 48 h, both high-dose groups had higher concentrations of both metabolites than the low-dose spironolactone group (P < 0.0001).","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Denus', 'Affiliation': 'Faculty of Pharmacy, Montreal, Canada.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Leclair', 'Affiliation': 'Faculty of Pharmacy, Montreal, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'St-Jean', 'Affiliation': 'Faculty of Pharmacy, Montreal, Canada.'}, {'ForeName': 'Yassamin Feroz', 'Initials': 'YF', 'LastName': 'Zada', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Essaïd', 'Initials': 'E', 'LastName': 'Oussaïd', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jutras', 'Affiliation': 'Faculty of Pharmacy, Montreal, Canada.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques-Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}]",European journal of heart failure,['10.1002/ejhf.1802']
351,31578771,"Add-on effects of tadalafil in tamsulosin-treated patients with small benign prostatic enlargement: A randomized, placebo-controlled, double-blind, crossover study.","AIM


To assess the add-on effects of tadalafil in patients with a relatively small benign prostatic enlargement (BPE) treated with tamsulosin.
METHODS


From September 2014 to July 2018, we prospectively studied patients (aged 50 years or more) attending our hospital who had received tamsulosin for small BPE (20-40 mL) for 4 weeks at least and still had residual lower urinary tract symptoms (LUTS) with total International Prostate Symptom Scores (IPSS) of at least 8 and IPSS-quality of life scores at least 3. We randomized eligible patients into two groups: one of which received tadalafil 5 mg once daily for 6 weeks, followed by placebo for 6 weeks, and the other of which received placebo followed by tadalafil in the same manner. The patients were reviewed at our outpatient clinic after 2, 6, 8, and 12 weeks.
RESULTS


There were 13 patients in the tadalafil-placebo and 13 in the placebo-tadalafil group. Their median ages (range) were 70 (65-85) and 73 (50-80) years, prostatic volumes (median) 30.0 (22.0-39.7) and 32.0 (20.1-39.5) mL, and total IPSS (median) 17 (10-27) and 16 (10-24), respectively. The primary endpoints, namely mean changes of total IPSS from baseline, were 1.85 on placebo and -3.42 on tadalafil; this difference is statistically significant (difference: -1.57; 95% confidence interval: -3.00, -0.69; P = .032). We encountered no adverse effects.
CONCLUSIONS


Add-on of tadalafil for symptomatic patients with small BPE treated with tamsulosin appears to be effective and safe.",2020,"The primary endpoints, namely mean changes of total IPSS from baseline, were 1.85 on placebo and -3.42 on tadalafil; this difference is statistically significant (difference: -1.57; 95% confidence interval: -3.00, -0.69; P = .032).","['symptomatic patients with small BPE treated with', 'treated patients with small benign prostatic enlargement', 'From September 2014 to July 2018, we prospectively studied patients (aged 50 years or more) attending our hospital who had received tamsulosin for small BPE (20-40\u2009mL) for 4 weeks at least and still had residual lower urinary tract symptoms (LUTS) with total International Prostate Symptom Scores (IPSS) of at least 8 and IPSS-quality of life scores at least 3', 'patients with a relatively small benign prostatic enlargement (BPE) treated with', 'Their median ages (range) were 70 (65-85) and 73 (50-80) years, prostatic volumes (median) 30.0 (22.0-39.7) and 32.0 (20.1-39.5)\u2009mL, and total IPSS (median']","['tadalafil 5\u2009mg once daily for 6 weeks, followed by placebo', 'tadalafil-placebo', 'placebo-tadalafil', 'placebo', 'placebo followed by tadalafil', 'tadalafil', 'tamsulosin']",['namely mean changes of total IPSS'],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1997470', 'cui_str': 'Total international prostate symptom score'}, {'cui': 'C0034380'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C1594297', 'cui_str': 'tadalafil 5 MG [Cialis]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.550511,"The primary endpoints, namely mean changes of total IPSS from baseline, were 1.85 on placebo and -3.42 on tadalafil; this difference is statistically significant (difference: -1.57; 95% confidence interval: -3.00, -0.69; P = .032).","[{'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Negoro', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Terada', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Omura', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsubara', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}]",Neurourology and urodynamics,['10.1002/nau.24175']
352,31917447,Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial.,"CONTEXT


Questions remain about bariatric surgery for type 2 diabetes mellitus (T2DM) treatment.
OBJECTIVE


Compare the remission of T2DM following surgical or nonsurgical treatments.
DESIGN, SETTING, AND PARTICIPANTS


Randomized controlled trial at the University of Pittsburgh, in the United States. Five-year follow-up from February 2015 until June 2016.
INTERVENTIONS


61 participants with obesity and T2DM who were initially randomized to either bariatric surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) or an intensive lifestyle weight loss intervention (LWLI) program for 1 year. Lower level lifestyle weight loss interventions (LLLIs) were then delivered for 4 years.
MAIN OUTCOMES AND MEASURES


Diabetes remission assessed at 5 years.
RESULTS


The mean age of the patients was 47 ± 6.6 years, 82% were women, and 21% African American. Mean hemoglobin A1c level 7.8% ± 1.9%, body mass index (BMI) 35.7 ± 3.1 kg/m2, and 26 participants (43%) had BMI < 35 kg/m2. Partial or complete T2DM remission was achieved by 30% (n = 6) of RYGB, 19% (n = 4) of LAGB, and no LWLI participants (P = .0208). At 5 years those in the RYGB group had the largest percentage of individuals (56%) not requiring any medications for T2DM compared with those in the LAGB (45%) and LWLI (0%) groups (P = .0065). Mean reductions in percent body weight at 5 years was the greatest after RYGB 25.2% ± 2.1%, followed by LAGB 12.7% ± 2.0% and lifestyle treatment 5.1% ± 2.5% (all pairwise P < .01).
CONCLUSIONS


Surgical treatments are more effective than lifestyle intervention alone for T2DM treatment.",2020,At 5 years those in the RYGB group had the largest percentage of individuals (56%) not requiring any medications for T2DM compared to those in the LAGB (45%) and LWLI (0%) groups (p=0.0065).,"['Diabetes', '61 participants with obesity and T2DM who were initially randomized to either', 'University of Pittsburgh, in the United States', 'The mean age of the patients was 47 ± 6.6 years, 82% were women, and 21% African American']","['intensive lifestyle weight loss intervention (LWLI) program', 'Bariatric Surgery vs. Lifestyle Intervention', 'bariatric surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB']","['Lower level lifestyle weight loss interventions (LLLI', 'Partial or complete T2DM remission', 'Body Mass Index (BMI']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",61.0,0.0492574,At 5 years those in the RYGB group had the largest percentage of individuals (56%) not requiring any medications for T2DM compared to those in the LAGB (45%) and LWLI (0%) groups (p=0.0065).,"[{'ForeName': 'Anita P', 'Initials': 'AP', 'LastName': 'Courcoulas', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Eagleton', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'DeLany', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': 'UniversitätsSpital Zürich Zentrum Alter und Mobilität, Zürich, Switzerland.'}, {'ForeName': 'Suriya', 'Initials': 'S', 'LastName': 'Punchai', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gourash', 'Affiliation': 'Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Physical Activity and Weight Management Research Center, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa006']
353,32239305,The novel mechanism of valproate to prevent peritoneal adhesion formation.,"PURPOSE


A novel pharmacological mechanism of valproate was analyzed using a hamster model of adhesion.
METHODS


Valproate or placebo was administered just after cecal injury and adhesion severity scores and histological were analyzed.
RESULTS


The adhesion severity scores in the placebo- and valproate-treated groups were 2.67 ± 0.42 and 1.0 ± 0.37, respectively, with a significant difference between the groups. A significant increase in mast cell numbers was observed in the placebo-treated group vs. the sham-operated group; however, the mast cell number in the adhesive lesion was significantly lower in the valproate-treated group than in the placebo-treated group. The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate. The myeloperoxidase gene expression level in the cecum was significantly higher in the placebo-treated group than in the sham-operated group, but there was no significant difference in the myeloperoxidase gene expression level between the sham-operated and valproate-treated groups in. In an in vitro experiment, valproate inhibited purified human and hamster chymases dose-dependently.
CONCLUSION


The chymase inhibitory effect of valproate may contribute to prevent adhesion formation after abdominal injury.",2020,"The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate.",[],"['placebo', 'valproate', 'Valproate or placebo']","['mast cell numbers', 'number of cells positive for chymase, an enzyme in mast cells', 'mast cell number in the adhesive lesion', 'adhesion severity scores', 'myeloperoxidase gene expression level', 'adhesive lesion']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]","[{'cui': 'C0024880', 'cui_str': 'Mast cell'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.194655,"The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate.","[{'ForeName': 'Shuangping', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China.'}, {'ForeName': 'Denan', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of Innovative Medicine, Osaka Medical College, Takatsuki, 569-8686, Japan.'}, {'ForeName': 'Qinggao', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China. zqg0621@ybu.edu.cn.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Takai', 'Affiliation': 'Department of Innovative Medicine, Osaka Medical College, Takatsuki, 569-8686, Japan. pha010@osaka-med.ac.jp.'}]",Surgery today,['10.1007/s00595-020-01979-8']
354,31237459,Effects of the Values and Options in Cancer Care Communication Intervention on Personal Caregiver Experiences of Cancer Care and Bereavement Outcomes.,"Background:  Care teams are increasingly expected to attend to the needs of patient's personal caregivers (e.g., family members). Improving communication among oncologists, patients with advanced cancer, and their personal caregivers might enhance caregivers' experiences of end-of-life (EoL) cancer care and bereavement outcomes.  Objective:  To explore the effects of the Values and Options in Cancer Care intervention on caregivers' experiences of EoL care and bereavement outcomes.  Design :  We developed a brief behavioral intervention to improve communication among oncologists, patients with advanced cancer, and their personal caregivers. The intervention was designed to help patients/caregivers ask questions, express concerns, and help oncologists respond effectively. We randomly assigned oncologists (and their patients/caregivers) to the intervention or usual care.  Setting/Subjects:  Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer.  Measurements:  Two months after the patient's death, caregivers completed three instruments assessing their experiences of EoL care. Seven months after the patient's death, caregivers completed the Prolonged Grief Disorder-13 (PG-13; primary prespecified outcome), the Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety.  Results :  The intervention did not significantly improve caregivers' scores on the PG-13 ( p  = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p  = 0.018). Cohen's  d  (95% confidence interval) for all three experiences of EoL care outcomes were promising, ranging from 0.22 (-0.19 to 0.63) to 0.39 (-0.07 to 0.86) although none was statistically significant.  Conclusion:  Preliminary findings show promise that scalable interventions in cancer care settings may improve caregiver experiences with cancer care and some bereavement outcomes.",2019,"The intervention did not significantly improve caregivers' scores on the PG-13 ( p  = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p  = 0.018).","['Setting/Subjects:  Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer', 'patients with advanced cancer, and their personal caregivers']","['Cancer Care Communication Intervention', 'Cancer Care intervention', 'intervention or usual care', 'behavioral intervention']","['Prolonged Grief Disorder-13', 'purpose-in-life scores', 'death', 'Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety', 'Personal Caregiver Experiences of Cancer Care and Bereavement Outcomes', ""caregivers' scores"", 'mental health function, depression, or anxiety']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1555767', 'cui_str': 'Medical oncologist (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}]",,0.0426869,"The intervention did not significantly improve caregivers' scores on the PG-13 ( p  = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p  = 0.018).","[{'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Radiology, Department of Medicine, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Fenton', 'Affiliation': 'Department of Family and Community Medicine, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Norton', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Tulane Cancer Center, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Marsha N', 'Initials': 'MN', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'UC Davis Comprehensive Cancer Center, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Cornell Center for Research on End-of-Life Care, Department of Medicine, Weill Cornell Medical College, New York, New York.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0078']
355,32243049,Evaluation of combination therapy with peeling added to minimal invasive blepharoplasty in lower eyelid rejuvenation.,"INTRODUCTION


Aging is an inevitable process in life that can pose unsatisfactory changes in appearance. Recently, rejuvenation surgeries have opened an exciting new window toward people who are vulnerable according to their facial appearance. Periocular plastic microsurgeries are among the most common aesthetic surgeries with various outcomes. The current study was aimed to compare outcomes of blepharoplasty with and without peeling regarding lower eyelid rejuvenation.
METHODS


This is a randomized clinical trial study conducted on 30-patients referred for inferior lid rejuvenation in 2017-18. Patients were randomly divided into two 15-member subgroups of microinvasive blepharoplasty with and without peeling. Peeling for the group underwent blepharopeeling was performed all over the inferior periocular region using Phenol 89%. Then, skin and underlying muscle were incised superficially, and underlying fat tissue was excised. The other group underwent blepharoplasty without peeling. Patients were followed daily for 2 months to assess complications, patients' and physicians' satisfaction.
RESULTS


Two assessed groups were not statistically different regarding age and gender distribution (P-value = .417 and .666, respectively). Considering patients' opinion, symmetry, scar formation, skin laxity, swelling, and total satisfaction score were not different between two groups (P-value > .05) while physicians presented similar outcomes except for better scar formation status of peeling add-on therapy (P-value = .042). Rate of adverse effects was significantly higher among those under blepharoplasty plus peeling treatment (P-value < .05).
CONCLUSION


Outcomes of blepharoplasty alone versus blepharoplasty plus peeling were not significantly different regarding both patients' and physicians' assessments in general while fewer complications due to blepharoplasty without peeling were presented.",2020,"Two assessed groups were not statistically different regarding age and gender distribution (P-value = .417 and .666, respectively).","['30-patients referred for inferior lid rejuvenation in 2017-18', 'lower eyelid rejuvenation']","['blepharoplasty alone versus blepharoplasty plus peeling', 'blepharoplasty with and without peeling regarding lower eyelid rejuvenation', 'blepharoplasty without peeling', 'microinvasive blepharoplasty with and without peeling', 'combination therapy with peeling added to minimal invasive blepharoplasty']","['Rate of adverse effects', 'symmetry, scar formation, skin laxity, swelling, and total satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}]","[{'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0010495', 'cui_str': 'Cutis laxa'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0756232,"Two assessed groups were not statistically different regarding age and gender distribution (P-value = .417 and .666, respectively).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Asilian', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Shahmoradi', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Talakoub', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Siadat', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohaghegh', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Adibi', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Mozafarpoor', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Kazemipour', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Danesh', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hafezi', 'Affiliation': 'Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13394']
356,31086222,"The Effect of Iranian Propolis on Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial.","Propolis is a natural product with many biological properties including hypoglycemic activity and modulating lipid profile. The present study was designed to evaluate the effect of Iranian propolis extract on glucose metabolism, Lipid profile, Insulin resistance, renal and liver function as well as inflammatory biomarkers in patients with type 2 diabetes mellitus (T2DM). A double-blind, placebo-controlled clinical trial was conducted. The duration of the study lasted 90 days. Patients with T2DM were recruited and randomly divided into an Iranian propolis group (1000 mg/day) (n = 50) and a placebo group (n = 44). There was a significant decrease in the serum levels of glycosylated hemoglobin (HbA1c), 2-hour post prandial (2hpp), insulin, homeostasis model assessment-insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), High sensitive C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α). However, there was a notable elevation in the serum HDL-C in the propolis group compared with the placebo group. In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed. Iranian propolis has beneficial effects on reducing post prandial blood glucose, serum insulin, insulin resistance, and inflammatory cytokines. It is also a useful treatment for preventing the liver and renal dysfunction, as well as, elevating HDL-C concentrations in patients with T2DM.",2019,"In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with T2DM', 'patients with T2DM']","['Iranian Propolis', 'placebo', 'Iranian propolis extract']","['serum levels of glycosylated hemoglobin (HbA1c), 2-hour post prandial (2hpp), insulin, homeostasis model assessment-insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), High sensitive C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α', 'glucose metabolism, Lipid profile, Insulin resistance, renal and liver function', 'post prandial blood glucose, serum insulin, insulin resistance, and inflammatory cytokines', 'serum HDL-C', 'serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations', 'Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.127932,"In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed.","[{'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Zakerkish', 'Affiliation': 'Diabetes research center, Health research institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jenabi', 'Affiliation': 'Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Zaeemzadeh', 'Affiliation': 'Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. zaeemzadeh_n@yahoo.com.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Hemmati', 'Affiliation': 'Medicinal Plant Research Center, School of pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Neisi', 'Affiliation': 'Department of Virology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Scientific reports,['10.1038/s41598-019-43838-8']
357,30982808,"Japan Trial in High-Risk Individuals to Enhance Their Referral to Physicians (J-HARP)-A Nurse-Led, Community-Based Prevention Program of Lifestyle-Related Disease.","BACKGROUND


It is uncertain whether health counselling after community-based health checkups for high-risk individuals of lifestyle-related disease enhances their referral to physicians.
METHODS


We performed a clustered randomized controlled trial of untreated high-risk individuals aged 40 to 74 years who were screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities. The high-risk conditions were severe forms of hypertension, diabetes, dyslipidemia (for men), and proteinuria. For the intervention group, the theory-based health counselling was performed to enhance referrals to physicians, while each municipality performed its own standard counselling for the usual care group. Data on clinical visits and risk factors were collected systematically and anonymously from the databases of health insurance qualification, health insurance claims, and annual health checkups. Hypotheses are that the cumulative proportion of seeing physicians (clinical visits) is higher in the intervention than the usual care groups, and that those in the intervention group have lower cumulative incidence of composite outcomes associated with lifestyle-related diseases.
RESULTS


The numbers of subjects for the analyses were 8,977 in the intervention group and 6,733 in the usual care group. Among them, 6,758 had hypertension, 2,147 had diabetes, 2,861 had dyslipidemia, and 1,221 had proteinuria in the intervention group, with corresponding numbers of 4,833, 1,517, 2,262, and 845, respectively, in the usual care group. There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
CONCLUSIONS


We expect to provide scientific evidence on the effectiveness of health counselling.",2020,"There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
","['untreated high-risk individuals aged 40 to 74 years, screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities', '6,758 had hypertension, 2,147 diabetes, 2,861 dyslipidemia, and 1,221 proteinuria in the intervention group, and 4,833, 1,517, 2,262 and 845 in the usual care group', 'High-risk Individuals to Accelerate their Referral to Physicians (J-HARP) - a Nurse-led, Community-based Prevention Program of Lifestyle-related Disease']",[],['mean levels and proportions of major cardiovascular risk factors'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0600182'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0487147,"There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
","[{'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Sairenchi', 'Affiliation': 'Department of Public Health, Dokkyo Medical University School of Medicine.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Kinuta', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Miyae', 'Initials': 'M', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Health Sciences, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Imano', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Kitamura', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'School of Nursing, Miyagi University.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Graduate School of Medicine Osaka City University.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Saito', 'Affiliation': 'Department of Community Health Systems Nursing, Ehime University Graduate School of Medicine.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'National Institute of Public Health.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Health Sciences, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}]",Journal of epidemiology,['10.2188/jea.JE20180194']
358,30948756,Baseline impulsivity may moderate L-DOPA effects on value-based decision-making.,"Research has indicated a major role of dopamine in decision-making processes, but the underlying mechanisms remain largely unknown due to inconsistency in effects of dopaminergic drugs. To clarify the impact of dopamine on impulsive choice, we administered 150 mg L-DOPA to 87 healthy adults in a randomized, placebo-controlled, double-blind, crossover study, evaluating performance in four value-based decision-making tasks. We predicted that baseline impulsivity would moderate L-DOPA effects. In support of our hypothesis, L-DOPA had no main effect on impulsive choice, but reduced risk-seeking for gains in more-impulsive subjects. Because L-DOPA effects may be influenced by body weight, we repeated our analyses on data from half of the sample (n = 44) with lower weight, anticipating a stronger effect. In addition to the effect on risk-seeking for gains, low-weight participants also exhibited baseline-dependent effects of L-DOPA on loss aversion and delay discounting. Our results are consistent with the hypothesis of an inverted U-shaped dopamine function in which both low and high extremes of dopamine signaling are associated with high-impulsive choice. Consideration of differential baseline impulsivity and body weight may resolve previous seemingly paradoxical pharmacological results and might deepen our understanding of dopaminergic mechanisms underlying impulsivity.",2019,"In support of our hypothesis, L-DOPA had no main effect on impulsive choice, but reduced risk-seeking for gains in more-impulsive subjects.",['87 healthy adults'],"['placebo', 'dopamine']","['risk-seeking for gains', 'loss aversion and delay discounting']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}]",87.0,0.1387,"In support of our hypothesis, L-DOPA had no main effect on impulsive choice, but reduced risk-seeking for gains in more-impulsive subjects.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petzold', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kienast', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Pooseh', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Department of Molecular and Medical Pharmacology and the Brain Research Institute, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goschke', 'Affiliation': 'Department of Psychology and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany. michael.smolka@tu-dresden.de.'}]",Scientific reports,['10.1038/s41598-019-42124-x']
359,31711229,Kinetics and Interrelations of the Renin Aldosterone Response to Acute Psychosocial Stress: A Neglected Stress System.,"CONTEXT


The renin-angiotensin-aldosterone system (RAAS) plays an important role in cardiovascular homeostasis and its dysfunction relates to negative health consequences. Acute psychosocial stress seems to activate the RAAS in humans, but stress kinetics and interrelations of RAAS parameters compared with a nonstress control group remain inconclusive.
OBJECTIVE


We systematically investigated in a randomized placebo-controlled design stress kinetics and interrelations of the reactivity of RAAS parameters measured in plasma and saliva to standardized acute psychosocial stress induction.
METHODS


58 healthy young men were assigned to either a stress or a placebo control group. The stress group underwent the Trier Social Stress Test (TSST), while the control group underwent the placebo TSST. We repeatedly assessed plasma renin, and plasma and salivary aldosterone before and up to 3 hours after stress/placebo. We simultaneously assessed salivary cortisol to validate successful stress induction and to test for interrelations.
RESULTS


Acute psychosocial stress induced significant increases in all endocrine measures compared with placebo-stress (all P ≤ .041). Highest renin levels were observed 1 minute after stress, and highest aldosterone and cortisol levels 10 and 20 minutes after stress, with salivary aldosterone starting earlier at 1 minute after stress. Renin completed recovery at 10 minutes, cortisol at 60 minutes, salivary aldosterone at 90 minutes, and plasma aldosterone at 180 minutes after stress. Stress increase scores of all endocrine measures related to each other, as did renin and cortisol areas under the curve with respect to increase (AUCi) and salivary and plasma aldosterone AUCi (all P ≤ .047).
CONCLUSIONS


Our findings suggest that in humans acute psychosocial stress induces a differential and interrelated RAAS parameter activation pattern. Potential implications for stress-related cardiovascular risk remain to be elucidated.",2020,"RESULTS


Acute psychosocial stress induced significant increases in all endocrine measures as compared to placebo-stress (p´s≤.041).","['acute psychosocial stress', '58 healthy young men']","['Trier-Social-Stress-Test (TSST', 'Renin-Angiotensin-Aldosterone-System (RAAS', 'renin aldosterone response', 'placebo-control group', 'placebo-TSST', 'placebo']","['endocrine measures', 'Renin completed recovery at 10min, cortisol at 60min, salivary aldosterone at 90min, and plasma aldosterone', 'plasma renin, plasma and salivary aldosterone', 'Highest renin levels', 'did renin and cortisol AUCi´s and salivary and plasma aldosterone AUCi´s']","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",58.0,0.0225281,"RESULTS


Acute psychosocial stress induced significant increases in all endocrine measures as compared to placebo-stress (p´s≤.041).","[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Gideon', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Fieres', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Renner', 'Affiliation': 'Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Petra H', 'Initials': 'PH', 'LastName': 'Wirtz', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz190']
360,32220252,Facilitators of and barriers to reducing thirty-day readmissions and improving patient-reported outcomes after surgical aortic valve replacement: a process evaluation of the AVRre trial.,"BACKGROUND


The Aortic Valve Replacement Readmission (AVRre) randomized control trial tested whether a telephone intervention would reduce hospital readmissions following surgical aortic valve replacement (SAVR). The telephone support provided 30 days of continuous phone-support (hotline) and two scheduled phone-calls from the hospital after discharge. The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants' anxiety compared to a control group receiving usual care. Depression and participant-reported health state were unaffected by the intervention. To better understand these outcomes, we conducted a process evaluation of the AVRre trial to gain insight into the (1) the dose and fidelity of the intervention, (2) mechanism of impacts, and (3) contextual factors that may have influenced the outcomes.
METHODS


The process evaluation was informed by the Medical Research Council framework, a widely used set of guidelines for evaluating complex interventions. A mix of quantitative (questionnaire and journal records) and qualitative data (field notes, memos, registration forms, questionnaire) was prospectively collected, and retrospective interviews were conducted. We performed descriptive analyses of the quantitative data. Content analyses, assisted by NVivo, were performed to evaluate qualitative data.
RESULTS


The nurses who were serving the 24/7 hotline intervention desired to receive more preparation before intervention implementation. SAVR patient participants were highly satisfied with the telephone intervention (58%), felt safe (86%), and trusted having the option of calling in for support (91%). The support for the telephone hotline staff was perceived as a facilitator of the intervention implementation. Content analyses revealed themes: ""gap in the care continuum,"" ""need for individualized care,"" and ""need for easy access to health information"" after SAVR. Differences in local hospital discharge management practices influenced the 30-DACR incidence.
CONCLUSIONS


The prospective follow-up of the hotline service during the trial facilitated implementation of the intervention, contributing to high participant satisfaction and likely reduced their anxiety after SAVR. Perceived less-than-optimal preparations for the hotline could be a barrier to AVRre trial implementation. Integrating user experiences into a mixed-methods evaluation of clinical trials is important for broadening understanding of trial outcomes, the mechanism of impact, and contextual factors that influence clinical trials.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02522663. Registered on 11 August 2015.",2020,The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants' anxiety compared to a control group receiving usual care.,"['surgical aortic valve replacement (SAVR', 'SAVR patient participants']","['surgical aortic valve replacement', 'telephone intervention']","['hospital readmissions', 'reducing 30-day all-cause readmission rate (30-DACR', '30-DACR incidence', 'felt safe', 'Depression and participant-reported health state']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3266157', 'cui_str': 'Feeling safe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.06011,The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants' anxiety compared to a control group receiving usual care.,"[{'ForeName': 'Stein Ove', 'Initials': 'SO', 'LastName': 'Danielsen', 'Affiliation': 'Center for Patient-centered Heart and Lung Research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Building 63, Ullevål, PO Box 4956, Nydalen, 0424, Oslo, Norway. steinove@oslomet.no.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Moons', 'Affiliation': 'KU Leuven Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Leegaard', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Division of Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Tønnessen', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lie', 'Affiliation': 'Center for Patient-centered Heart and Lung Research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Building 63, Ullevål, PO Box 4956, Nydalen, 0424, Oslo, Norway.'}]",BMC health services research,['10.1186/s12913-020-05125-5']
361,31904995,Outcomes Six Months after Delivering 100% or 70% of Enteral Calorie Requirements during Critical Illness (TARGET). A Randomized Controlled Trial.,"Rationale:  The long-term effects of delivering approximately 100% of recommended calorie intake via the enteral route during critical illness compared with a lesser amount of calories are unknown. Objectives:  Our hypotheses were that achieving approximately 100% of recommended calorie intake during critical illness would increase quality-of-life scores, return to work, and key life activities and reduce death and disability 6 months later. Methods:  We conducted a multicenter, blinded, parallel group, randomized clinical trial, with 3,957 mechanically ventilated critically ill adults allocated to energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition. Measurements and Main Results:  Participants assigned energy-dense nutrition received more calories (percent recommended energy intake, mean [SD]; energy-dense: 103% [28] vs. usual: 69% [18]). Mortality at Day 180 was similar (560/1,895 [29.6%] vs. 539/1,920 [28.1%]; relative risk 1.05 [95% confidence interval, 0.95-1.16]). At a median (interquartile range) of 185 (182-193) days after randomization, 2,492 survivors were surveyed and reported similar quality of life (EuroQol five dimensions five-level quality-of-life questionnaire visual analog scale, median [interquartile range]: 75 [60-85]; group difference: 0 [95% confidence interval, 0-0]). Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work ( n  = 818). There was no observed difference in disability ( n  = 1,208) or participation in key life activities ( n  = 705). Conclusions:  The delivery of approximately 100% compared with 70% of recommended calorie intake during critical illness does not improve quality of life or functional outcomes or increase the number of survivors 6 months later.",2020,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,['3957 mechanically ventilated critically ill adults allocated to'],['energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition'],"['quality of life (EuroQol five dimensions five-level quality of life questionnaire visual analogue scale, median [IQR', 'quality of life scores, return to work and key life activities and reduce death and disability six months later', 'Mortality', 'quality of life, or functional outcomes', 'disability (n=1208) or participation in key life activities']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.628334,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Melbourne Medical School, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Davies', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Ferrie', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hurford', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Peake', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Presneill', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Medical School, Australian National University, Canberra, Australia; and.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1810OC']
362,32234247,Does 20-min rounding reduce falls in an aged-care setting? A pilot intervention study.,"BACKGROUND


This study investigated if implementation of a 20-min rounding intervention can reduce falls in aged care settings.
METHODS


Participants (aged 66-99 years) from five aged care facilities were randomly allocated to intervention (n = 20) or control groups (n = 21). The intervention consisted of 20-min rounding observations over a six month period. The number of falls for all residents of each aged care facility was also collected.
RESULTS


For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108). There was a trend for a decreased average number of falls across all aged care sites (mean±SD, 60.4 ± 35.7 falls occurred prior vs. 53.4 ± 37.4 during the intervention, p = 0.056). There were no fall related fractures in the intervention group during the study.
CONCLUSIONS


This study suggests that 20-min rounding may decrease falls for all residents of aged care sites.",2020,"For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108).",['Participants (aged 66-99\xa0years) from five aged care facilities'],['20-min rounding intervention'],"['number of falls', 'average number of falls']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0575126', 'cui_str': 'Number of falls'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0367425,"For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108).","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Roberts', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia. Electronic address: Bronwyn.Roberts@wdhs.net.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Holloway-Kew', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Tatum', 'Initials': 'T', 'LastName': 'Pretorius', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hosking', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Armstrong', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.03.003']
363,31977576,The effects of antihypertensive class on gout in older adults: secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.,"OBJECTIVES


Gout is a common complication of blood pressure management and a frequently cited cause of medication nonadherence. Little trial evidence exists to inform antihypertensive selection with regard to gout risk.
METHODS


The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) was a randomized clinical trial on the effects of first-step hypertension therapy with amlodipine, chlorthalidone, or lisinopril on fatal coronary heart disease or nonfatal myocardial infarction (1994-2002). Trial participants were linked to CMS and VA gout claims (ICD9 274.XX). We determined the effect of drug assignment on gout with Cox regression models. We also determined the adjusted association of self-reported atenolol use (ascertained at the 1-month visit for indications other than hypertension) with gout.
RESULTS


Claims were linked to 23 964 participants (mean age 69.8 ± 6.8 years, 45% women, 31% black). Atenolol use was reported by 928 participants at the 1-month visit. Over a mean follow-up of 4.9 years, we documented 597 gout claims. Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril. Lisinopril nonsignificantly lowered gout risk compared with chlorthalidone (hazard ratio 0.85; 95% CI 0.70--1.03). Atenolol use was not associated with gout risk (adjusted hazard ratio 1.18; 95% CI 0.78--1.80). Gout risk reduction was primarily observed after 1 year of follow-up.
CONCLUSION


Amlodipine lowered long-term gout risk compared with lisinopril or chlorthalidone. This finding may be useful in cases where gout risk is a principal concern among patients being treated for hypertension.This trial is registered at clinicaltrials.gov, number: NCT00000542.",2020,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"['Claims were linked to 23\u200a964 participants (mean age 69.8\u200a±\u200a6.8 years, 45% women, 31% black', 'older adults', '928 participants at the 1-month visit', 'patients being treated for hypertension']","['Lisinopril', 'amlodipine, chlorthalidone, or lisinopril', 'lisinopril', 'chlorthalidone', 'Amlodipine', 'lisinopril or chlorthalidone', 'Atenolol', 'antihypertensive class']","['risk of gout', 'fatal coronary heart disease or nonfatal myocardial infarction', 'Gout risk reduction', 'gout risk']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",23964.0,0.236379,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lara M', 'Initials': 'LM', 'LastName': 'Simpson', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shmerling', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beach', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ishak', 'Affiliation': 'Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Journal of hypertension,['10.1097/HJH.0000000000002359']
364,31980861,Intramedullary fixation versus anatomically contoured plating of unstable ankle fractures: a randomized control trial.,"AIM


This study compared functional outcomes between anatomical shaped fibular plates and intramedullary nail fixation of adult patients who sustained unstable ankle fractures.
METHODS


A prospective randomized control trial was conducted between November 2013 and December 2016 on patients that presented with an unstable ankle fractures. They were randomized into a plate-and-screw group and a fibula nail group. At each post-operative visit the wounds were reviewed, and specific outcome measures were recorded, which included (i) the patient reported outcome measure (PROM) Olerud and Molander functional score, (ii) the Grimby score, (iii) swelling around the malleoli, (iv) plantar flexion, (v) dorsiflexion, (vi) inversion, and (vi) eversion.
RESULTS


Significant differences were observed in scar size (p < 0.001) and screening time (p < 0.001) whilst no differences were observed in functional and PROM measures. Although not statistically significant, of clinical value is one deep infection that occurred in the plate group, whilst no infections occurred in the nail group.
CONCLUSION


Both fixation methods yielded very similar functional results with differences only in scar size, screening time and swelling. Although none of these warrant a change in surgical decision-making processes, taken together, these factors potentially influence the decisions made in terms of surgical modalities used.",2020,"RESULTS


Significant differences were observed in scar size (p < 0.001) and screening time (p < 0.001) whilst no differences were observed in functional and PROM measures.","['November 2013 and December 2016 on patients that presented with an unstable ankle fractures', 'unstable ankle fractures', 'adult patients who sustained unstable ankle fractures']","['plate-and-screw group and a fibula nail group', 'anatomical shaped fibular plates and intramedullary nail fixation', 'Intramedullary fixation versus anatomically contoured plating']","['scar size', 'screening time', 'functional and PROM measures', 'outcome measure (PROM) Olerud and Molander functional score, (ii) the Grimby score, (iii) swelling around the malleoli, (iv) plantar flexion, (v) dorsiflexion, (vi) inversion, and (vi) eversion', 'scar size, screening time and swelling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]","[{'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}]",,0.0384906,"RESULTS


Significant differences were observed in scar size (p < 0.001) and screening time (p < 0.001) whilst no differences were observed in functional and PROM measures.","[{'ForeName': 'Dhs', 'Initials': 'D', 'LastName': 'Badenhorst', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, Stellenbosch, 7505, South Africa.'}, {'ForeName': 'Ips', 'Initials': 'I', 'LastName': 'Terblanche', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, Stellenbosch, 7505, South Africa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ferreria', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, Stellenbosch, 7505, South Africa.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Burger', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, Stellenbosch, 7505, South Africa. mcburger@sun.ac.za.'}]",International orthopaedics,['10.1007/s00264-020-04482-4']
365,31325802,Kynurenine metabolism and inflammation-induced depressed mood: A human experimental study.,"Inflammation has an important physiological influence on mood and behavior. Kynurenine metabolism is hypothesized to be a pathway linking inflammation and depressed mood, in part through the impact of kynurenine metabolites on glutamate neurotransmission in the central nervous system. This study evaluated whether the circulating concentrations of kynurenine and related compounds change acutely in response to an inflammatory challenge (endotoxin administration) in a human model of inflammation-induced depressed mood, and whether such metabolite changes relate to mood change. Adults (n = 115) were randomized to receive endotoxin or placebo. Mood (Profile of Mood States), plasma cytokine (interleukin-6, tumor necrosis factor-α) and metabolite (kynurenine, tryptophan, kynurenic acid, quinolinic acid) concentrations were repeatedly measured before the intervention, and at 2 and 6 h post-intervention. Linear mixed models were used to evaluate relationships between mood, kynurenine and related compounds, and cytokines. Kynurenine, kynurenic acid, and tryptophan (but not quinolinic acid) concentrations changed acutely (p's all <0.001) in response to endotoxin as compared to placebo. Neither kynurenine, kynurenic acid nor tryptophan concentrations were correlated at baseline with cytokine concentrations, but all three were significantly correlated with cytokine concentrations over time in response to endotoxin. Quinolinic acid concentrations were not correlated with cytokine concentrations either before or following endotoxin treatment. In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing. Changes in tryptophan and kynurenine pathway metabolites did not mediate the relationship between cytokines and depressed mood. Further work is necessary to clarify the pathways leading from inflammation to depressed mood in humans.",2019,"In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing.",['Adults (n\u202f=\u202f115'],"['endotoxin or placebo', 'placebo', 'endotoxin, kynurenine']","['Mood (Profile of Mood States), plasma cytokine (interleukin-6, tumor necrosis factor-α) and metabolite (kynurenine, tryptophan, kynurenic acid, quinolinic acid) concentrations', 'quinolinic acid', 'kynurenine, kynurenic acid nor tryptophan concentrations', 'Kynurenine, kynurenic acid, and tryptophan', 'Quinolinic acid concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0022816', 'cui_str': '2-Quinolinecarboxylic acid, 4-hydroxy-'}, {'cui': 'C0072879', 'cui_str': '2,3-Pyridinedicarboxylic acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0299068,"In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kruse', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}, {'ForeName': 'Joshua Hyong-Jin', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States. Electronic address: hjcho@mednet.ucla.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Olmstead', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Hwang', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States; Pasarow Mass Spectrometry Laboratory, University of California Los Angeles, United States.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Faull', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States; Pasarow Mass Spectrometry Laboratory, University of California Los Angeles, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Department of Psychology, University of California Los Angeles, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104371']
366,31537194,Blood Pressure Variability and Cardiovascular Outcomes in Patients With Prior Stroke: A Secondary Analysis of PRoFESS.,"Background and Purpose- Every year in the United States, almost 185 000 ischemic strokes occur in patients with a prior stroke. Recurrent stroke has significantly higher morbidity and mortality. Among modifiable risk factors for recurrent stroke, hypertension is the most prevalent. Reducing systolic blood pressure is standard of care for secondary stroke prevention. Recent literature suggests that increased blood pressure variability (BPV) is associated with primary stroke, although studies have not convincingly shown that it is associated with recurrent stroke, which was the goal of this analysis. Methods- We conducted a secondary analysis of 17 916 patients in the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial, which is the largest trial of patients with potential recurrent stroke. We calculated BPV and evaluated its effect on recurrent stroke (composite and stratified by ischemic or hemorrhagic stroke), major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure), and all-cause death. Results- Both systolic and diastolic BPV were associated with recurrent stroke, major cardiovascular events, and all-cause death. The association with stroke was significant for ischemic, but not hemorrhagic, stroke. For every 10-point increase in BPV (systolic SD, range =0-54.2), the hazard ratio for a recurrent ischemic stroke was 1.15 (95% CI, 1.02-1.32;  P =0.02), for major cardiovascular events was 1.19 (95% CI, 1.09-1.31;  P <0.001), and for all-cause death was 1.24 (95% CI, 1.10-1.39;  P <0.001). Conclusions- Our study adds to the growing body of literature suggesting that BPV is an important and potentially modifiable risk factor for ischemic stroke, cardiovascular events, and all-cause death. Specifically, it is the first study to demonstrate that increased BPV is associated with recurrent ischemic stroke and that diastolic BPV can be as important as systolic BPV. Future work should focus on evaluating whether actively reducing BPV, using widely available and inexpensive antihypertensive medications, reduces the risk of cardiovascular disease.",2019,"The association with stroke was significant for ischemic, but not hemorrhagic, stroke.","['17\u2009916 patients in the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial, which is the largest trial of patients with potential recurrent stroke', 'Patients']","[' and Purpose', 'Methods', 'Conclusions']","['major cardiovascular events', 'BPV', 'recurrent stroke (composite and stratified by ischemic or hemorrhagic stroke), major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure), and all-cause death. Results', 'systolic blood pressure', 'recurrent stroke, major cardiovascular events', 'morbidity and mortality', 'blood pressure variability (BPV', 'hazard ratio for a recurrent ischemic stroke', 'systolic and diastolic BPV', 'Blood Pressure Variability and Cardiovascular Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.151981,"The association with stroke was significant for ischemic, but not hemorrhagic, stroke.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Nora F', 'Initials': 'NF', 'LastName': 'Fino', 'Affiliation': 'Division of Epidemiology, Department of Internal Medicine (N.F.F.), University of Utah, Salt Lake City.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Ka-Ho', 'Initials': 'KH', 'LastName': 'Wong', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Majersik', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tirschwell', 'Affiliation': 'Department of Neurology, University of Washington, Seattle (D.T.).'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rost', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston (N.R.).'}]",Stroke,['10.1161/STROKEAHA.119.026293']
367,31879812,The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial.,"PURPOSE


The aim of this study was to evaluate the effects of a high initial-dose (60 mg/kg) intravenous tranexamic acid (IV-TXA) on fibrinolysis and inflammation after total knee arthroplasty (TKA).
METHODS


A total of 132 patients were categorized into two groups based on different TXA regimens: 20 mg/kg before incision (A) or 60 mg/kg before incision (B). All patients received five doses of 1 g TXA at three, six, 12, 18, and 24 hours after the first dose. The primary outcomes were peri-operative blood loss and transfusion rate. Other outcome measurements such as, haemoglobin level, fibrinolysis parameters [fibrin(-ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6)], visual analog scale (VAS) score, consumption of analgesic rescue, coagulation parameters [activated partial thromboplastin time (APTT), prothrombin time (PT), platelet count, thrombelastography (TEG), and anti-factor Xa activity (AFXa)] and complications, were also compared.
RESULTS


There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A. In addition, the levels of FDP, D-dimer, CRP, IL-6, and dynamic pain in Group B were significantly lower than those in Group A on post-operative days one, two and three. There were no statistically significant differences in postoperative coagulation parameters and complications between the two groups.
CONCLUSION


A high initial-dose (60 mg/kg) IV-TXA before surgery followed by five doses can further reduce blood loss, provide additional fibrinolysis and inflammation control, and ameliorate post-operative pain following TKA, without increasing the risk of treatment-related complications.",2020,"There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A.","['after total knee arthroplasty (TKA', 'total knee arthroplasty', '132 patients']","['high initial-dose (60\xa0mg/kg) intravenous tranexamic acid (IV-TXA', 'TXA regimens: 20\xa0mg/kg before incision (A) or 60\xa0mg/kg before incision (B', 'tranexamic acid']","['levels of FDP, D-dimer, CRP, IL-6, and dynamic pain', 'haemoglobin level, fibrinolysis parameters [fibrin(-ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6)], visual analog scale (VAS) score, consumption of analgesic rescue, coagulation parameters [activated partial thromboplastin time (APTT), prothrombin time (PT), platelet count, thrombelastography (TEG), and anti-factor Xa activity (AFXa)] and complications', 'blood loss', 'postoperative coagulation parameters and complications', 'peri-operative blood loss and transfusion rate', 'fibrinolysis and inflammation']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0294942', 'cui_str': '(18F)FDP'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0722236', 'cui_str': 'Ogen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",132.0,0.1163,"There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A.","[{'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400016, People's Republic of China. huangw511@163.com.""}, {'ForeName': 'Fu-Xing', 'Initials': 'FX', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China. peifux@126.com.""}]",International orthopaedics,['10.1007/s00264-019-04469-w']
368,32228267,An effective early death scoring system for predicting early death risk in  de novo  acute promyelocytic leukemia.,"The Sanz risk, which was originally used to predict the risk of acute promyelocytic leukemia (APL) relapse, is a recognized method to predict the prognosis of APL. About 570  de novo  APL patients admitted to our center were randomly divided into a training cohort ( N  = 344) and validation cohort ( N  = 226). Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 × 10 9 /L (OR = 4.254,  p  < .001), and LDH level >500 U/L (OR= 3.002,  p  = .046) were independent risk factors for early death. A risk score (age >52: 1.5 points; WBC >10 × 10 9 /L: 2 points; PLT ≤10 × 10 9 /L: 1 point; LDH >500 U/L: 1 point) was used to predict early death risk. The model shows a better predictive power of early death in training cohort and validation cohort compared with Sanz risk stratification.",2020,"Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 ","['de novo  APL patients admitted to our center', 'de novo  acute promyelocytic leukemia', 'About 570']",[],"['LDH level', 'white blood cell count', 'acute promyelocytic leukemia (APL) relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]",[],"[{'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",570.0,0.0287751,"Multivariate analysis of training cohort demonstrated that age >52 (OR = 5.170,  p  = .002), white blood cell count >10 × 10 9 /L (OR = 9.062,  p  < .001), PLT count ≤10 ","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Cai', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yemin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xinyou', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Second Clinical Medical College of Jinan University, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Suning', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'NHC Key Laboratory of Thrombosis and Hemostasis, National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1742910']
369,31517663,"Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects.","BACKGROUND


OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects.
OBJECTIVE


To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects.
METHODS


This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety.
RESULTS


Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate.
CONCLUSION


Repeated onabotulinumtoxinA was effective and well tolerated.",2020,Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar.,"['Japanese subjects', ""glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects"", 'Japanese Subjects', '44 U (n = 48) or 32 U (n = 53) for']","['onabotulinumtoxinA', 'CFL and GL', 'OnabotulinumtoxinA', 'CFL']","['responder rates', 'proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety', 'effective and well tolerated', 'Safety, Efficacy, and Patient Satisfaction', 'CFL appearance', 'safety and efficacy']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",,0.0343399,Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Department of Dermatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Harii', 'Affiliation': 'Department of Plastic Surgery, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Horiuchi', 'Affiliation': 'Akihabara Skin Clinic, Tokyo, Japan.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seidman', 'Affiliation': 'Peloton Advantage, LLC, Parsippany, New Jersey.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hopfinger', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002143']
370,31526122,Neighborhood Socioeconomic Status and Trajectories of Physical Health-Related Quality of Life Among Stroke Survivors.,"Background and Purpose- Stroke is the leading cause of serious, long-term disability in the United States, and the number of stroke survivors is projected to rise. Physical functioning status may be compromised in survivors living in low socioeconomic status environments in comparison to higher socioeconomic status environments. Higher socioeconomic status environments may include benefits in the built environment such as sidewalks, accessible transit, or low traffic volume. Investigation is needed to understand the effects of the socioenvironmental context on trajectories of stroke survivors' physical health-related quality of life (PH-QOL) over time. Methods- Participants from the REGARDS (REasons for Geographic and Racial Differences in Stroke) study enrolled in the ancillary Caring for Adults Recovering from the Effects of Stroke project completed the SF-12 around 6 to 12, 18, 27, and 36 months poststroke. Measures of area-level income, wealth, education, and employment at the census tract level were combined to represent participants' neighborhood socioeconomic status. Linear mixed models were used to predict trajectories of PH-QOL over time, controlling for individual characteristics. Results- The average trajectory of PH-QOL was flat over time. However, women and younger stroke survivors had better trajectories over time than men and older stroke survivors. Higher neighborhood socioeconomic status was significantly associated with better PH-QOL across all time points (β=1.73; 95% CI, 0.17-3.30), after controlling for demographic variables and severity of stroke. Conclusions- Our findings demonstrate that neighborhood socioeconomic status, sex, and age are associated with the poststroke recovery process. The results of this study suggest the importance of evaluating the environment surrounding stroke survivors when they return to their home communities. Future research should identify specific features of the environment within different socioeconomic status neighborhoods to better understand how they contribute to PH-QOL among stroke survivors.",2019,"Higher neighborhood socioeconomic status was significantly associated with better PH-QOL across all time points (β=1.73; 95% CI, 0.17-3.30), after controlling for demographic variables and severity of stroke.","['Stroke) study enrolled in the ancillary Caring for Adults Recovering from the Effects of Stroke project completed the SF-12 around 6 to 12, 18, 27, and 36 months poststroke', 'women and younger stroke survivors']","[' and Purpose', 'Methods', 'Conclusions']","['area-level income, wealth, education, and employment at the census tract level', 'Higher neighborhood socioeconomic status', 'Neighborhood Socioeconomic Status and Trajectories of Physical Health-Related Quality of Life', 'average trajectory of PH-QOL', 'PH-QOL']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0007663', 'cui_str': 'Censuses'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0533061,"Higher neighborhood socioeconomic status was significantly associated with better PH-QOL across all time points (β=1.73; 95% CI, 0.17-3.30), after controlling for demographic variables and severity of stroke.","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Twardzik', 'Affiliation': 'From the School of Kinesiology (E.T., N.C.), University of Michigan, Ann Arbor.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Department of Epidemiology, School of Public Health (E.T., P.C.), University of Michigan, Ann Arbor.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Elliott', 'Affiliation': 'Institute for Social Research (P.C., M.R.E., N.C.), University of Michigan, Ann Arbor.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'School of Aging Studies, College of Behavioral and Community Science, University of South Florida, Tampa (W.E.H.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Judd', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham (S.J.).'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'From the School of Kinesiology (E.T., N.C.), University of Michigan, Ann Arbor.'}]",Stroke,['10.1161/STROKEAHA.119.025874']
371,31276809,Prophylactic Fentanyl Sublingual Spray for Episodic Exertional Dyspnea in Cancer Patients: A Pilot Double-Blind Randomized Controlled Trial.,"CONTEXT


The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.
OBJECTIVES


We examined the effect of two doses of prophylactic FSS on exertional dyspnea.
METHODS


In this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%-45% (high dose) or 15%-25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function.
RESULTS


Thirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change -1.42; 95% CI -2.37, -0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change -0.47; 95% CI -1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected.
CONCLUSION


Prophylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials.",2019,P=0.24) and significant increase in walk distance (mean change 24 m; P=0.01) compared to baseline.,"['Cancer Patients', 'cancer patients', 'Thirty of the 50 enrolled patients completed the study']","['Prophylactic Fentanyl Sublingual Spray', 'opioid-tolerant', 'fentanyl sublingual spray (FSS', 'prophylactic FSS']","['dyspnea', 'vital signs or neurocognitive function', 'exertional dyspnea', 'Episodic Exertional Dyspnea', 'walk distance', 'adverse events as well as changes in walk distance, vital signs, and neurocognitive function', 'modified dyspnea Borg scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1273658', 'cui_str': 'Sublingual spray'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0518766'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion (finding)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}]",50.0,0.647755,P=0.24) and significant increase in walk distance (mean change 24 m; P=0.01) compared to baseline.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Farley', 'Initials': 'F', 'LastName': 'Hernandez', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Larsson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kilgore', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Naberhuis', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Virgilio', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Driver', 'Affiliation': 'Department of Pain Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.024']
372,31574025,Electrosclerotherapy as a Novel Treatment Option for Hypertrophic Capillary Malformations: A Randomized Controlled Pilot Trial.,"BACKGROUND


Bleomycin sclerotherapy is ineffective for treating capillary malformations (CMs) because bleomycin cannot adequately be injected into the small-diameter capillary lumina. Electrosclerotherapy (EST) might be a new treatment modality for CMs, as it combines bleomycin sclerotherapy and ""electroporation""-an electric field applied to the tissue. Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
OBJECTIVE


To explore the efficacy, safety, and feasibility of EST for CMs in a randomized within-patient controlled pilot study.
MATERIALS AND METHODS


Fifteen regions of interest (ROI) within the hypertrophic CMs of 5 patients were randomly allocated to EST, bleomycin injection, or no treatment. Outcome was assessed after 7 weeks by the patient and a blinded outcome assessor using the patient-observer scar assessment score (POSAS), global assessment of change (GAC), colorimetry, and laser speckle contrast imaging.
RESULTS


Color and hypertrophy of all ROIs treated with EST significantly improved, based on the POSAS (medians patient -11; observer -13), GAC, and colorimetry (ΔE 3.4-16.5) scores.
CONCLUSION


This pilot study demonstrates the first proof of concept for electrosclerotherapy as a new treatment modality for CMs. Further research is warranted.",2020,"Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
","['Fifteen regions of interest (ROI) within the hypertrophic CMs of 5 patients', 'Hypertrophic Capillary Malformations']","['Electrosclerotherapy', 'EST', 'electrosclerotherapy', 'EST, bleomycin injection, or no treatment', 'Electrosclerotherapy (EST', 'Bleomycin sclerotherapy', 'bleomycin', 'bleomycin sclerotherapy']","['efficacy, safety, and feasibility', 'patient-observer scar assessment score (POSAS), global assessment of change (GAC), colorimetry, and laser speckle contrast imaging']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340803', 'cui_str': 'Capillary Malformations, Congenital, 1'}]","[{'cui': 'C0600510', 'cui_str': 'ESTs'}, {'cui': 'C4060395', 'cui_str': 'Bleomycin Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}]",15.0,0.0631886,"Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
","[{'ForeName': 'Sophie E R', 'Initials': 'SER', 'LastName': 'Horbach', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wolkerstorfer', 'Affiliation': 'Dermatology, and.'}, {'ForeName': 'Folkert', 'Initials': 'F', 'LastName': 'Jolink', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Bloemen', 'Affiliation': 'Biomedical Engineering and Physics, Academic Medical Center (AMC), Amsterdam University Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Chantal M A M', 'Initials': 'CMAM', 'LastName': 'van der Horst', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002191']
373,32222134,Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
METHODS


In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
RESULTS


Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
CONCLUSIONS


Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).",2020,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","['patients with high-risk heart failure', 'patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received', 'Patients with Heart Failure and Reduced Ejection Fraction', '5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive']","['vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy', 'placebo', 'intravenous diuretic therapy']","['syncope', 'Death from cardiovascular causes', 'Symptomatic hypotension', 'composite of death from cardiovascular causes or first hospitalization for heart failure', 'death from cardiovascular causes or hospitalization for heart failure', 'hospitalized for heart failure', 'composite of death from any cause or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",5050.0,0.580875,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915928']
374,32225032,The Effect of the Promotion of Vegetables by a Social Influencer on Adolescents' Subsequent Vegetable Intake: A Pilot Study.,"Marketers have found new ways of reaching adolescents on social platforms. Previous studies have shown that advertising effectively increases the intake of unhealthy foods while not so much is known about the promotion of healthier foods. Therefore, the main aim of the present experimental pilot study was to examine if promoting red peppers by a popular social influencer on social media (Instagram) increased subsequent actual vegetable intake among adolescents. We used a randomized between-subject design with 132 adolescents (age: 13-16 y). Adolescents were exposed to an Instagram post by a highly popular social influencer with vegetables (n = 44) or energy-dense snacks (n = 44) or were in the control condition (n = 44). The main outcome was vegetable intake. Results showed no effect of the popular social influencer promoting vegetables on the intake of vegetables. No moderation effects were found for parasocial interaction and persuasion knowledge. Bayesian results were consistent with the results and supported evidence against the effect of the experimental condition. Worldwide, youth do not consume the recommended amount of fruit and vegetables, making it important to examine if mere exposure or different forms of food promotion techniques for healthier foods are effective in increasing the intake of these foods.",2020,No moderation effects were found for parasocial interaction and persuasion knowledge.,"[""Adolescents' Subsequent Vegetable Intake"", '132 adolescents (age: 13-16 y', 'adolescents']","['Promotion of Vegetables by a Social Influencer', 'Instagram post by a highly popular social influencer with vegetables (n = 44) or energy-dense snacks']","['intake of vegetables', 'parasocial interaction and persuasion knowledge', 'vegetable intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]",132.0,0.0251539,No moderation effects were found for parasocial interaction and persuasion knowledge.,"[{'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research, Barcelona, 08018 Barcelona, Spain.'}, {'ForeName': 'Manouk', 'Initials': 'M', 'LastName': 'de Bruijne', 'Affiliation': 'Independent Researcher, De Boelelaan 1101, 1081 HV Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072243']
375,31899552,Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.,"BACKGROUND


Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT.
METHODS


We conducted an unblinded, randomized trial of a psychosocial intervention (BMT-CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT-CARE or usual care. BMT-CARE was tailored to the HCT trajectory and integrated treatment-related education and self-care with cognitive-behavioral skills to promote coping. Caregivers assigned to BMT-CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT-CARE on outcomes longitudinally.
RESULTS


We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = -2.18; 95% CI, -3.07 to -1.28; P < .001) and depression symptoms (B = -1.23; 95% CI, -1.92 to -0.54; P < .001), and improved self-efficacy (B = 7.22; 95% CI, 2.40-12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04-6.94; P < .001) in comparison with the usual-care group.
CONCLUSIONS


A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self-efficacy while reducing the caregiving burden during the acute HCT period.",2020,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","['Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience', 'We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions', 'caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital', 'family caregivers of patients undergoing hematopoietic stem cell transplantation', 'caregivers of HCT recipients']","['Multimodal psychosocial intervention', 'psychosocial intervention (BMT-CARE', 'BMT-CARE', 'trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing', 'BMT-CARE or usual care']","['QOL', 'reduced caregiving burden', 'coping skills', 'self-efficacy', 'QOL, mood, coping, and self-efficacy', 'caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status', 'lower anxiety', 'depression symptoms']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0222045'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.165701,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Showly', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Waldman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Fenech', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""D'Alotto"", 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horick', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spitzer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Zachariah', 'Initials': 'Z', 'LastName': 'DeFilipp', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Yi-Bin A', 'Initials': 'YA', 'LastName': 'Chen', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32680']
376,32222255,Heart Rate Determination in Newborns at Risk for Resuscitation in a Low-Resource Setting: A Randomized Controlled Trial.,"OBJECTIVE


To compare 2 different methods (auscultation with a stethoscope and umbilical cord palpation) of heart rate (HR) estimation in newborns at risk for resuscitation in a low-resource setting.
STUDY DESIGN


Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia) were randomized to HR assessment by auscultation using a stethoscope or umbilical cord palpation. HR was assessed at 60, 90, 120 seconds, and 5 minutes of life. The primary outcome was the agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram.
RESULTS


Mean difference between auscultation using a stethoscope and electrocardiogram was -13 bpm, -4 bpm, -6 bpm, and -10 bpm at 60, 90, 120 seconds, and at 5 minutes of life. Mean difference between palpation and electrocardiogram of was -20 bpm, -25 bpm, -23 bpm, and -31 bpm at 60, 90, 120 seconds, and at 5 minutes of life. The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time (P = .007). HR range was correctly identified in 14 out of 16 measurements (87%) with HR <100 bpm.
CONCLUSION


HR assessment by auscultation was more accurate compared with cord palpation, but both may provide adequate clinical information to healthcare providers in terms of HR ranges. The clinical advantage of providing a stethoscope in low-resource settings remains to be established.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03854435.",2020,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"['Newborns at Risk for Resuscitation in a Low-Resource Setting', 'Sixty newborns at risk for resuscitation born at the St. Luke Catholic Hospital in Wolisso (Ethiopia', 'newborns at risk for resuscitation in a low-resource setting']","['methods (auscultation with a stethoscope and umbilical cord palpation', 'HR assessment by auscultation using a stethoscope or umbilical cord palpation']","['agreement of HR obtained by auscultation or palpation compared with the HR determined by electrocardiogram', 'heart rate (HR) estimation', 'HR range']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0183559', 'cui_str': 'Stethoscopes'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.112529,The magnitude of the difference between auscultation and electrocardiogram was lower than that between palpation and electrocardiogram over time,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Independent statistician, Solagna, Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cori', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Senait', 'Initials': 'S', 'LastName': 'Negash', 'Affiliation': 'Department of Pediatrics, St. Luke Catholic Hospital, Wolisso, Ethiopia.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Azzimonti', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Wolisso, Ethiopia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Department of Woman and Child Health, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Research Office, Doctors with Africa CUAMM, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Woman's and Child's Health, University of Padova, Padova, Italy. Electronic address: daniele.trevisanuto@unipd.it.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.026']
377,30251569,The effect of group prenatal care for women with diabetes on social support and depressive symptoms: a pilot randomized trial.,"Objective:  To measure the impact of group prenatal care (GPC) on diabetes-specific peer support and depressive symptoms in women with pregnancies complicated by diabetes. Materials and methods:  This is a planned secondary analysis of a two-center pilot randomized controlled trial conducted at Denver health (DH) and Washington University in St. Louis (WU) including Spanish (DH) or English (WU) speaking women with type 2 or gestational diabetes. Women were randomized to diabetes GPC or individual prenatal care (IPC) in the resident diabetes clinic. Participants completed an Edinburgh Postnatal Depression Scale (EPDS) at randomization, at 38-week gestation and at 6-12 weeks postpartum. The diabetes support scale (DSS), which includes 12 questions answered on a Likert scale, was administered at 38 weeks. Analysis was by intention to treat (clincaltrials.gov#NCT02444325). Results:  A total of 84 women were consented and randomized. Six withdrew consent (two from each cohort) or were lost to follow-up (two from IPC), and three did not complete the 38-week assessment (two from GPC and one from IPC), resulting in primary outcome data available for 75 women: 38 in GPC and 37 in IPC. More women randomized to GPC reported composite positive peer support on the DSS (52.5 versus 26.3%;  p  < .02). There were no differences in EPDS scores, depression (EPDS >10), or rates of improved EPDS score from baseline to 38 weeks. Conclusion:  GPC for women with diabetes is associated with improved diabetes-specific peer social support with no significant impact on depressive symptoms. Clinical trial registration:  Clincaltrials.gov NCT02444.",2020,"There were no differences in EPDS scores, depression (EPDS >10), or rates of improved EPDS score from baseline to 38 weeks.
","['75 women: 38 in GPC and 37 in IPC', 'women with diabetes on social support and depressive symptoms', 'Denver health (DH) and Washington University in St. Louis (WU) including Spanish (DH) or English (WU) speaking women with type 2 or gestational diabetes', 'women with diabetes', 'A total of 84 women were consented and randomized', 'women with pregnancies complicated by diabetes']","['diabetes GPC or individual prenatal care (IPC', 'group prenatal care (GPC', 'GPC']","['diabetes support scale (DSS', 'EPDS scores, depression (EPDS >10), or rates of improved EPDS score', 'DSS', 'Edinburgh Postnatal Depression Scale (EPDS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037438'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}]",84.0,0.310633,"There were no differences in EPDS scores, depression (EPDS >10), or rates of improved EPDS score from baseline to 38 weeks.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mazzoni', 'Affiliation': 'University of Albama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Hill', 'Affiliation': 'Denver Health and Hospital Authority, Denver, Colorado, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'University of Colorado Hospital, Aurora, Colorado, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barbier', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Cahill', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Macones', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Methodius', 'Initials': 'M', 'LastName': 'Tuuli', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Ebony', 'Initials': 'E', 'LastName': 'Carter', 'Affiliation': 'Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1520832']
378,32216471,Bivalirudin Versus Heparin Monotherapy in Elderly Patients With Myocardial Infarction: A Prespecified Subgroup Analysis of the VALIDATE-SWEDEHEART Trial.,"BACKGROUND


Elderly patients with acute myocardial infarction undergoing percutaneous coronary intervention are at increased risk of both ischemic and bleeding complications. The optimal anticoagulation strategy in these patients is uncertain. Therefore, we compared bivalirudin to heparin monotherapy in a contemporary cohort of such patients.
METHODS


A prespecified subgroup analysis of elderly patients with myocardial infarction (≥75 years) from the VALIDATE-SWEDEHEART trial (Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) was performed. In the trial, patients were randomized to either bivalirudin or heparin monotherapy during percutaneous coronary intervention, with mandatory potent P2Y12 inhibition, routine radial artery access, and only bail-out glycoprotein IIb/IIIa inhibition. Kaplan-Meier event rates were assessed for the primary end point, consisting of a composite of all-cause death, myocardial reinfarction, or major bleeding, within 180 days.
RESULTS


The elderly (n=1592) had more than twice the risk of all events compared with younger patients (n=4406). Baseline and periprocedural characteristics were equal between bivalirudin (n=799) and heparin (n=793) treated patients ≥75 years. No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke.
CONCLUSIONS


In this prespecified subgroup analysis of the VALIDATE-SWEDEHEART trial, elderly patients with myocardial infarction had a highly increased risk of all events. However, no difference in outcomes could be observed with an anticoagulation strategy with either bivalirudin or heparin as monotherapy in this patient group.",2020,"No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke.
","['in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease', 'Elderly patients with acute myocardial infarction undergoing', 'elderly patients with myocardial infarction', 'Elderly Patients With Myocardial Infarction', 'elderly patients with myocardial infarction (≥75 years']","['Heparin Monotherapy', 'heparin monotherapy', 'Bivalirudin', 'Bivalirudin Versus Heparin', 'heparin', 'bivalirudin or heparin monotherapy', 'percutaneous coronary intervention', 'bivalirudin']","['cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke', 'death, myocardial reinfarction, or major bleeding', 'Kaplan-Meier event rates']","[{'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.115487,"No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke.
","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wester', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Attar', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}, {'ForeName': 'Moman A', 'Initials': 'MA', 'LastName': 'Mohammad', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Isma', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden (S.J.).'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (E.O.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Sweden (A.W., R.A., M.A.M., N.I., D.E., S.K.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008671']
379,32020470,Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial.,"BACKGROUND


Tumor treating fields (TTFields) are anti-mitotic, non-invasive loco-regional cancer therapy comprising low intensity, intermediate frequency alternating electric fields. TTFields plus Temozolomide (TTFields/TMZ) extended survival versus TMZ alone in newly diagnosed glioblastoma (GBM) patients in the EF-14 trial. We report on Korean newly diagnosed GBM patients who participated in the EF-14 trial.
METHODS


Thirty-nine participants of the EF-14 trial were enrolled at 8 sites in South Korea. Patients (24 TTFields/TMZ; 14 TMZ alone) received: TTFields (200 kHz) for > 18 h/day; TMZ at 120-150 mg for 5 days per a 28 day cycle. Safety and efficacy were assessed.
RESULTS


Patient baseline characteristics were balanced in the 2 arms and the mean age was 52.1 years, 66.7% were male with a mean KPS of 90. Safety incidence was comparable between the 2 arms. In the TTFields/TMZ arm, 30% suffered from skin irritation versus 52% in the entire study population. No TTFields-related serious adverse events were reported. The median progression-free survival (PFS) in the TTFields/TMZ arm was 6.2 months (95% CI 4.2-12.2) versus 4.2 (95% CI 1.9-11.2) with TMZ alone (p = 0.67). Median overall survival was 27.2 months (95% CI 21-NA) with TTFields/TMZ versus 15.2 months (95% CI 7.5-24.1; HR 0.27, p = 0.01) with TMZ alone.
CONCLUSION


Median OS and 1- and 2-year survival rates were higher with TTFields/TMZ and similar to the entire EF-14 population. About 30% of patients reported skin irritation, a lower rate than seen in the entire EF-14 population. These results demonstrate the efficacy and safety of TTFields in Korean newly diagnosed glioblastoma patients.
CLINICAL TRIALS


Clinicaltrials.gov Identifier: NCT00916409.",2020,Safety incidence was comparable between the 2 arms.,"['Korean patients in the EF-14 phase 3 trial', 'Thirty-nine participants of the EF-14 trial were enrolled at 8 sites in South Korea', 'Korean newly diagnosed GBM patients who participated in the EF-14 trial', 'newly diagnosed glioblastoma (GBM) patients in the EF-14 trial', 'Patient baseline characteristics were balanced in the 2 arms and the mean age was 52.1\xa0years, 66.7% were male with a mean KPS of 90', 'Korean newly diagnosed glioblastoma patients', 'newly diagnosed glioblastoma']","['temozolomide', 'TMZ', 'Temozolomide (TTFields/TMZ']","['serious adverse events', 'Median OS and 1- and 2-year survival rates', 'Median overall survival', 'median progression-free survival (PFS', 'Safety and efficacy', 'efficacy and safety of TTFields', 'Safety incidence', 'skin irritation']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}]",,0.247546,Safety incidence was comparable between the 2 arms.,"[{'ForeName': 'Chae-Yong', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University College of Medicine, Seoul, South Korea. chaeyong@snu.ac.kr.'}, {'ForeName': 'Sun Ha', 'Initials': 'SH', 'LastName': 'Paek', 'Affiliation': 'Department of Neurosurgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Do-Hyun', 'Initials': 'DH', 'LastName': 'Nam', 'Affiliation': 'Department of Neurosurgery, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, Yonsei University Health System Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Yong-Kil', 'Initials': 'YK', 'LastName': 'Hong', 'Affiliation': 'Department of Neurosurgery, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Oh Lyong', 'Initials': 'OL', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Yeungnam University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Se-Hyuk', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Ajou University Hosptial, Suwon, South Korea.'}]",Journal of neuro-oncology,['10.1007/s11060-019-03361-2']
380,32092717,Effects of Bisoprolol Transdermal Patches for Prevention of Perioperative Myocardial Injury in High-Risk Patients Undergoing Non-Cardiac Surgery　- Multicenter Randomized Controlled Study.,"BACKGROUND


The aim of this study was to evaluate the efficacy and safety of transdermal β-blocker patches, which offer stable blood concentration and easy availability during operation, for prevention of perioperative myocardial injury (PMI) in high-risk patients.Methods and Results:In this randomized controlled trial, patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery were randomly assigned to a bisoprolol patch or control group. Primary efficacy outcome was incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT) >0.014ng/mL and relative hs-cTnT change ≥20%. Secondary efficacy outcomes were number of cardiovascular events and 30-day mortality. From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study. The incidence of PMI was 35.7% in the bisoprolol patch group and 44.5% in the control group (P=0.18). Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia was similar between the 2 groups. Tachyarrhythmia tended to be higher in the control group. There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
CONCLUSIONS


Bisoprolol patches do not influence the incidence of PMI and cardiovascular events in high-risk patients undergoing non-cardiac surgery, but perioperative use of these patches is safe.",2020,"There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
","['high-risk patients undergoing non-cardiac surgery', 'High-Risk Patients Undergoing Non-Cardiac Surgery\u3000- Multicenter', 'high-risk patients', 'patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery', 'From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study']","['bisoprolol patch or control group', 'Bisoprolol Transdermal Patches']","['efficacy and safety', 'incidence of PMI and cardiovascular events', 'safety outcomes including significant hypotension and bradycardia', 'Perioperative Myocardial Injury', 'number of cardiovascular events and 30-day mortality', 'Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia', 'incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT', 'Tachyarrhythmia', 'incidence of PMI']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3164217', 'cui_str': 'Revised cardiac risk index (assessment scale)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}]",,0.316886,"There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ejiri', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Iwano', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Hikasa', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morimatsu', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0871']
381,31628121,Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol.,"INTRODUCTION


Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (<34 weeks) preeclampsia, investigating (1) the interval between enrolment and delivery (days), (2) biomarkers of placental and endothelial function and (3) maternal and fetal outcomes.
METHODS


A double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A.
ETHICS AND DISSEMINATION


Approval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data will be published in peer-reviewed journals and presented at learnt society conferences, both nationally and internationally. This study has not yet commenced and is pre-results. Trial registration number ACTRN12618000216213.",2019,"Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites.","['women with early onset (<34 weeks) preeclampsia, investigating (1) the interval between enrolment and delivery (days), (2) biomarkers of placental and endothelial function and (3) maternal and fetal outcomes', 'Consenting women', 'One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines', 'women with early onset preeclampsia']","['placebo', 'broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo', 'Broccoli sprout extract, rich in the antioxidant sulforaphane', 'broccoli sprout extract']",['oxidative stress and placental secretion'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1707048', 'cui_str': 'broccoli sprout extract'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",180.0,0.722779,"Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites.","[{'ForeName': 'Annie G', 'Initials': 'AG', 'LastName': 'Langston-Cox', 'Affiliation': 'Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Marshall', 'Affiliation': 'Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kirsten R', 'Initials': 'KR', 'LastName': 'Palmer', 'Affiliation': 'Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Euan M', 'Initials': 'EM', 'LastName': 'Wallace', 'Affiliation': 'Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia euan.wallace@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2018-027493']
382,32170033,Randomised trial of azithromycin to eradicate  Ureaplasma  in preterm infants.,"OBJECTIVE


To test whether azithromycin eradicates  Ureaplasma  from the respiratory tract in preterm infants.
DESIGN


Prospective, phase IIb randomised, double-blind, placebo-controlled trial.
SETTING


Seven level III-IV US, academic, neonatal intensive care units (NICUs).
PATIENTS


Infants 24 0 -28 6  weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6  weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.
INTERVENTIONS


Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.
MAIN OUTCOME MEASURES


The primary efficacy outcome was  Ureaplasma -free survival. Secondary outcomes were all-cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support.
RESULTS


One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were  Ureaplasma  positive (azithromycin: n=19; placebo: n=25).  Ureaplasma -free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract  Ureaplasma  colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract  Ureaplasma  colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.
CONCLUSION


A 3-day azithromycin regimen effectively eradicated respiratory tract  Ureaplasma  colonisation in this study.
TRIAL REGISTRATION NUMBER


NCT01778634.",2020,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","['27 0', '21 infants with lower respiratory tract  Ureaplasma  colonisation', 'n=60', 'preterm infants', 'Forty-four of 121 participants (36%) were', 'Seven level III-IV US, academic, neonatal intensive care units (NICUs', 'One hundred and twenty-one randomised participants', 'Infants 24 0']","['azithromycin', 'Azithromycin', 'placebo', 'Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo']","['Ureaplasma -free survival', ""cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support"", 'neonatal mortality and morbidity', 'Mortality', 'physiological BPD-free survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",21.0,0.779323,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","[{'ForeName': 'Rose Marie', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA rviscard@som.umaryland.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dulkerian', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Donohue', 'Affiliation': 'Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Tuttle', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Jorn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hazem E', 'Initials': 'HE', 'LastName': 'Hassan', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Eddington', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318122']
383,31418516,Predictors of response to insulin therapy in youth with poorly-controlled type 2 diabetes in the TODAY trial.,"OBJECTIVE


To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study.
METHODS


Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.9 ± 1.0 visits since the time of insulin initiation. Participants were divided into three groups according to glycemic control: consistent decrease in HbA1c by ≥0.5%, change <0.5%, or consistent increase in HbA1c ≥0.5%, at 75% or more of the visits.
RESULTS


Within 1-year postinsulin initiation, 33.2% of participants had a consistent HbA1c decrease of ≥0.5%, 46.2% changed HbA1c <0.5%, and 20.6% had an increase ≥0.5%. At randomization into TODAY and at time of insulin initiation, the three glycemia groups were similar in age, sex, race-ethnicity, pubertal stage, BMI z-score, diabetes duration, and insulin secretion indices. Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
CONCLUSIONS


Response to add-on insulin was highly variable among youth in TODAY. Greater insulin sensitivity and higher adiponectin concentrations at randomization were associated with improved glycemic control after initiation of insulin. Due to limited information on adherence to insulin injections, the roles of adherence to the prescribed insulin regimen or psychosocial factors are unknown.",2019,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","['youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with', 'youth with poorly-controlled type 2 diabetes', '253 youth had a mean of 3.9\u2009±\u20091.0 visits since the time of insulin initiation']","['metformin alone, metformin\u2009+\u2009rosiglitazone or metformin\u2009+\u2009lifestyle', 'insulin therapy']","['insulin sensitivity', 'Greater insulin sensitivity and higher adiponectin concentrations']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",253.0,0.0741428,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","[{'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Children's Nutrition Research Center, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, Maryland.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""UPMC, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Zeitler', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Gandica', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Chang', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, Louisiana.""}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Sprague', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Macleish', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12906']
384,31271239,Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes.,"BACKGROUND


This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes.
METHODS


After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks.
RESULTS


Participants in the reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps < .01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5% ± 1.2% at baseline to 9.0% ± 1.3% at week 6 and 9.0% ± 1.4% at week 12. For EUC, A1c was 9.2% ± 0.2% at baseline and ranged from 9.2% ± 1.5% to 9.6% ± 1.6% throughout the study (P < .05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement.
CONCLUSIONS


Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.",2019,Group differences in A1c were no longer significant at weeks 24 and 36.,"['60 participants were randomized to', 'youth with poorly controlled type 1 diabetes', 'adolescents with type 1 diabetes', 'rewards']","['enhanced usual care (EUC) or Reinforcers', 'monetary-based reinforcement intervention']","['self-monitoring blood glucose (SMBG', 'mean A1c', 'proportion of days they completed >4 SMBG', 'SMBG']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",60.0,0.0605448,Group differences in A1c were no longer significant at weeks 24 and 36.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'Behavioral Sciences & Community Health, University of Connecticut School of Dental Medicine, Farmington, Connecticut.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Petry', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Weyman', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tichy', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}]",Pediatric diabetes,['10.1111/pedi.12889']
385,31182217,"A multi-component, family-focused and literacy-sensitive intervention to improve medication adherence in patients with heart failure-A randomized controlled trial.","BACKGROUND


Medication nonadherence is prevalent and links to serious outcomes (e.g., rehospitalization/death) in heart failure (HF) patients; therefore, an urgent need exists for an intervention to improve and sustain adherence after intervention completion.
OBJECTIVES


To test the efficacy of a multi-component, family-focused, literacy-sensitive (FamLit) intervention on medication adherence in HF patients.
METHODS


Forty-three HF patients and their care partners were enrolled and randomized to receive FamLit or attention-only intervention, including an in-person session at baseline and bi-weekly phone boosters for 3 months. We measured medication adherence from baseline to 3-month post-intervention using the Medication Event Monitoring System.
RESULTS


After 3-month intervention, intervention patients had significantly better medication adherence than control patients. At 6 months (3-months post-intervention), intervention effect on adherence was sustained in the FamLit intervention group, while adherence decreased in the control group.
CONCLUSION


Incorporating care partner support and providing an easy-to-understand intervention to patients-care partners may improve/sustain adherence.",2019,"At 6 months (3-months post-intervention), intervention effect on adherence was sustained in the FamLit intervention group, while adherence decreased in the control group.
","['heart failure (HF) patients', 'Forty-three HF patients and their care partners', 'patients with heart failure', 'HF patients']","['FamLit or attention-only intervention, including an in-person session at baseline and bi-weekly phone boosters', 'multi-component, family-focused, literacy-sensitive (FamLit) intervention', 'multi-component, family-focused and literacy-sensitive intervention']","['medication adherence', 'adherence']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",43.0,0.0616371,"At 6 months (3-months post-intervention), intervention effect on adherence was sustained in the FamLit intervention group, while adherence decreased in the control group.
","[{'ForeName': 'Jia-Rong', 'Initials': 'JR', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC, United States. Electronic address: jiarongw@email.unc.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mark', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC, United States.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Knafl', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC, United States.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'School of Nursing, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Patricia P', 'Initials': 'PP', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, School of Medicine, University of North Carolina at Chapel Hill, NC, United States.'}, {'ForeName': 'Darren A', 'Initials': 'DA', 'LastName': 'DeWalt', 'Affiliation': 'Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina at Chapel Hill, NC, United States.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2019.05.011']
386,31537189,Intravenous Glibenclamide Reduces Lesional Water Uptake in Large Hemispheric Infarction.,"Background and Purpose- Prior studies have shown a linear relationship between computed tomography (CT)-derived radiodensity and water uptake, or brain edema, within stroke lesions. To test the hypothesis that intravenous glibenclamide (glyburide; BIIB093) reduces ischemic brain water uptake, we quantified the lesional net water uptake (NWU) on serial CT scans from patients enrolled in the phase 2 GAMES-RP Trial (Glyburide Advantage in Malignant Edema and Stroke). Methods- This was a post hoc exploratory analysis of the GAMES-RP study. Noncontrast CT scans performed between admission and day 7 (n=264) were analyzed in the GAMES-RP modified intention-to-treat sample. Quantitative change in CT radiodensity (ie, NWU) and midline shift (MLS) was measured. The gray and white matter NWU were also examined separately. Repeated-measures mixed-effects models were used to assess the effect of intravenous glibenclamide on MLS or NWU. Results- A median of 3 CT scans (interquartile range, 2-4) were performed per patient during the first 7 days after stroke. In a repeated-measures regression model, greater NWU was associated with increased MLS (β=0.23; 95% CI, 0.20-0.26;  P <0.001). Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53;  P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28;  P =0.016). Treatment with intravenous glibenclamide reduced both gray and white matter water uptake. In mediation analysis, gray matter NWU (β=0.15; 95% CI, 0.11-0.20;  P <0.001) contributed to a greater proportion of MLS mass effect, as compared with white matter NWU (β=0.08; 95% CI, 0.03-0.13;  P =0.001). Conclusions- In this phase 2 post hoc analysis, intravenous glibenclamide reduced both water accumulation and mass effect after large hemispheric infarction. This study demonstrates NWU is a quantitative and modifiable biomarker of ischemic brain edema accumulation. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01794182.",2019,"Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53;  P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28;  P =0.016).","['patients enrolled in the phase 2 GAMES-RP Trial (Glyburide Advantage in Malignant Edema and Stroke', 'Large Hemispheric Infarction']","[' and Purpose', 'Methods', 'glibenclamide (glyburide', 'glibenclamide', 'Conclusions', 'Intravenous Glibenclamide']","['Lesional Water Uptake', 'gray and white matter water uptake', 'lesional net water uptake (NWU', 'Quantitative change in CT radiodensity (ie, NWU) and midline shift (MLS', 'reduced MLS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0017105', 'cui_str': 'Gas Gangrene'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0682708'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",264.0,0.184044,"Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53;  P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28;  P =0.016).","[{'ForeName': 'Pongpat', 'Initials': 'P', 'LastName': 'Vorasayan', 'Affiliation': 'From the Division of Neurocritical Care and Center for Genomic Medicine, Massachusetts General Hospital, Boston (P.V., W.T.K.).'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Bevers', 'Affiliation': ""Divisions of Stroke, Cerebrovascular and Critical Care Neurology, Brigham and Women's Hospital, Boston, MA (M.B.B.).""}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beslow', 'Affiliation': ""Departments of Neurology (L.A.B.), Division of Neurology, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sze', 'Affiliation': 'Division of Neuroradiology, Department of Radiology (G.S.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Molyneaux', 'Affiliation': 'Department of Neurology, University of Pittsburgh, PA (B.J.M.).'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': 'Department of Neurology, Oregon Health Sciences University, Portland (H.E.H.).'}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland, Baltimore (J.M.S.).'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Kummer', 'Affiliation': 'Department of Neuroradiology, Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.).'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology (K.N.S.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'W Taylor', 'Initials': 'WT', 'LastName': 'Kimberly', 'Affiliation': 'From the Division of Neurocritical Care and Center for Genomic Medicine, Massachusetts General Hospital, Boston (P.V., W.T.K.).'}]",Stroke,['10.1161/STROKEAHA.119.026036']
387,31540617,Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.,"BACKGROUND


There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease.
METHODS


In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat.
RESULTS


Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU.
CONCLUSION


ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.",2019,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","['patients with HIV and liver disease', 'January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score\u202f>\u202f1.45']","['ISAT', 'Integrated stepped alcohol treatment', 'health handout plus routine care', 'integrated stepped alcohol treatment (ISAT', 'ISAT and TAU']","['liver biomarkers', 'Abstinence rates', 'proportion with an undetectable HIV viral load', 'alcohol use, HIV, and liver outcomes', 'VACS Index scores', 'FIB-4 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",95.0,0.155409,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY 13244, United States of America.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.007']
388,32221809,Study of ultrasound-guided needle aspiration and catheter drainage in the management of liver abscesses.,"PURPOSE


To evaluate and compare the efficacy of intermittent needle aspiration and continuous catheter drainage in ultrasound-guided management of liver abscesses.
METHODS


This was a prospective, randomised study conducted on 100 patients (88 males and 12 females; age range 22-74 years) with liver abscess(es) and having abscess size more than 5 cm, divided into two groups: Percutaneous needle aspiration (PNA) (n = 50) and percutaneous catheter drainage (PCD) (n = 50). Criteria of exclusion were: rupture of abscess before intervention; prior intervention; uncorrectable coagulopathy; concomitant biliary tract malignancy. In the PNA group, pus was aspirated by an 18-gauge needle using freehand technique and the number of aspirations was limited to two. Failure of abscess size to decline below 50% of the original diameter or of clinical improvement after second aspiration was considered as failure of aspiration. In the PCD group, drainage was done by 12-French catheters using Seldinger technique. Drainage was considered as failure if abscess cavity did not resolve and laparotomy was needed to evacuate the pus cavity.
RESULT


The success rate in the PNA group was 88% and 92% in the PCD group; however, this difference was statistically not significant, suggesting that both are equally efficacious. The total duration of hospital stay (mean 6.8 days [PNA] vs 10.5 days [PCD]; p value: 0.011) and the average duration between intervention and discharge (5.9 days [PNA] vs 10.2 days [PCD]; p value:0.026) were significantly less in the PNA group. One major complication was seen in our study: peritonitis due to peri-catheter leak in PCD group.
CONCLUSION


Both procedures are equally efficacious in the management of liver abscesses; however in view of less duration of hospital stay, patient safety and comfort, procedure simplicity, and the reduced cost, needle aspiration should be used as the first-line procedure in the treatment of liver abscess (even in abscesses more than 5 cm). Catheter drainage should be reserved for cases that do not respond to a second attempt of aspiration.",2020,"Both procedures are equally efficacious in the management of liver abscesses; however in view of less duration of hospital stay, patient safety and comfort, procedure simplicity, and the reduced cost, needle aspiration should be used as the first-line procedure in the treatment of liver abscess (even in abscesses more than 5 cm).","['liver abscesses', '100 patients (88 males and 12 females; age range 22-74\xa0years) with liver abscess(es) and having abscess size more than 5\xa0cm, divided into two groups']","['Percutaneous needle aspiration (PNA) (n\u2009=\u200950) and percutaneous catheter drainage (PCD', 'ultrasound-guided needle aspiration and catheter drainage', 'Catheter drainage', 'intermittent needle aspiration and continuous catheter drainage']","['success rate', 'total duration of hospital stay']","[{'cui': 'C0023885', 'cui_str': 'Abscess, Hepatic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",100.0,0.0151742,"Both procedures are equally efficacious in the management of liver abscesses; however in view of less duration of hospital stay, patient safety and comfort, procedure simplicity, and the reduced cost, needle aspiration should be used as the first-line procedure in the treatment of liver abscess (even in abscesses more than 5 cm).","[{'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Surya', 'Affiliation': 'Department of Radiodiagnosis, RPGMC, Kangra, HP, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhoil', 'Affiliation': 'Department of Radiodiagnosis, RPGMC, Kangra, HP, India. rohitbhoil@gmail.com.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiodiagnosis, RPGMC, Kangra, HP, India.'}]",Journal of ultrasound,['10.1007/s40477-020-00440-3']
389,32213797,Use of Topical Tranexamic Acid to Reduce Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion.,"STUDY DESIGN


Nonrandomized, prospective, and case-controlled study.
PURPOSE


To evaluate the efficacy and cost-effectiveness of topically applied tranexamic acid (TXA) during different phases of spine surgery.
OVERVIEW OF LITERATURE


Perioperative blood loss is the leading cause of postoperative anemia associated with prolonged stays in hospital and long recovery times. The direct and indirect costs involved pose a significant economic challenge in developing countries. There is no consensus for topical use of tranexamic acid in spine surgery.
METHODS


Patients requiring a single-level TLIF were divided into two groups. In the TXA group (n=75), the wound surface was soaked with TXA (1 g in 100 mL saline solution) for 3 minutes after exposure, after decompression, and before wound closure, and in the control group (n=175) using only saline. Intraoperative blood loss drain volume was recorded on each of the first 2 days immediately after surgery. An estimated cost analysis was made on the basis of the length of hospital stay and the blood transfusion.
RESULTS


IBL for the control group was 783.33±332.71 mL and for intervention group 410.57±189.72 mL (p<0.001). The operative time for control group was 3.24±0.38 hours and for intervention group 2.99±0.79 hours (p<0.695). Hemovac drainage on days 1 and 2 for control group was 167.10±53.83 mL and 99.33±37.5 mL, respectively, and for intervention group 107.03±44.37 mL and 53.38±21.99 mL, respectively (p<0.001). The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days). The cost of treatment in the intervention group was US dollar (USD) 4,552.57±1,222.6 compared with that in the control group USD 6,529.9±1,505.04.
CONCLUSIONS


Topical TXA is a viable, cost-effective method of decreasing perioperative blood loss in major spine surgery with fewer overall complications than other methods. Further studies are required to find the ideal dosage and timing.",2020,The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days).,"['Single-Level Transforaminal Lumbar Interbody Fusion', 'Methods\n\n\nPatients requiring a single-level TLIF']","['control group (n=175) using only saline', 'tranexamic acid', 'TXA', 'Topical TXA', 'tranexamic acid (TXA', 'Topical Tranexamic Acid']","['efficacy and cost-effectiveness', 'Hemovac drainage', 'length of stay', 'Intraoperative blood loss drain volume', 'operative time', 'Blood Loss']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",,0.0543874,The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days).,"[{'ForeName': 'Abhinandan Reddy', 'Initials': 'AR', 'LastName': 'Mallepally', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Tarush', 'Initials': 'T', 'LastName': 'Rustagi', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Shakti Amar', 'Initials': 'SA', 'LastName': 'Goel', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Kalidutta', 'Initials': 'K', 'LastName': 'Das', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Harvinder Singh', 'Initials': 'HS', 'LastName': 'Chhabra', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}]",Asian spine journal,['10.31616/asj.2019.0134']
390,32103160,Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.,"OBJECTIVE


To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.
STUDY DESIGN


Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).
RESULTS


Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.
CONCLUSION


A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.",2020,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","['preterm neonates that met study criteria (n\u2009=\u2009169', 'premature neonates', 'preterm neonates', 'preterm neonates experiencing a clinically required heel lance']","['Oral dextrose', 'oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2\u2009min before heel lance', '30% oral dextrose']","['premature infant pain profile-revised (PIPP-R', 'plasma markers of ATP utilization and oxidative stress', 'biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress', 'Pain', 'procedural pain', 'Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C3179031', 'cui_str': 'Facilitated Tucking'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}]",169.0,0.263784,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","[{'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA. dangeles@llu.edu.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'School of Public Health, Loma Linda Univeristy, Loma Linda, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'School of Nursing, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hopper', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Aprille', 'Initials': 'A', 'LastName': 'Febre', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pegis', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lavery', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Munaf', 'Initials': 'M', 'LastName': 'Kadri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Mousselli', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Vora', 'Initials': 'V', 'LastName': 'Farha', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Fayard', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0634-0']
391,32216011,Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction.,"AIMS


The effects of vericiguat vs. placebo on high-sensitivity C-reactive protein (hsCRP) and serum uric acid (SUA) were assessed in patients with heart failure with reduced ejection fraction (HFrEF) in the Phase 2 SOCRATES-REDUCED study (NCT01951625).
METHODS AND RESULTS


Changes from baseline hsCRP and SUA values at 12 weeks with placebo and vericiguat (1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg, respectively) were assessed. The probability of achieving an hsCRP value of ≤3.0 mg/L or SUA value of <7.0 mg/dL at week 12 was tested. Median baseline hsCRP and SUA levels were 3.68 mg/L [interquartile range (IQR) 1.41-8.41; n = 335] and 7.80 mg/dL (IQR 6.40-9.33; n = 348), respectively. Baseline-adjusted mean percentage changes in hsCRP were 0.2%, -19.5%, -24.3%, -25.7% and -31.9% in the placebo and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the vericiguat 10.0 mg group (P = 0.035). Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively). Estimated probability for an end-of-treatment hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL was higher with vericiguat compared with placebo. The effect was dose-dependent, with the greatest effect observed in the 10.0 mg group.
CONCLUSIONS


Vericiguat treatment for 12 weeks was associated with reductions in hsCRP and SUA, and a higher likelihood of achieving an hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL.",2020,"Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively).","['vericiguat-treated patients with heart failure with reduced ejection fraction', 'patients with heart failure with reduced ejection fraction (HFrEF) in the Phase\u20092']","['vericiguat vs. placebo', 'placebo', 'high-sensitivity C-reactive protein and uric acid', 'placebo and vericiguat']","['SUA', 'high-sensitivity C-reactive protein (hsCRP) and serum uric acid (SUA', 'hsCRP', 'Median baseline hsCRP and SUA levels']","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",348.0,0.118843,"Baseline-adjusted mean percentage changes in SUA were 5.0%, -1.3%, -1.1%, -3.5% and -5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kramer', 'Affiliation': 'Medical Devices and eHealth Clinical, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Voss', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Clinical Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Bernd-Wolfgang', 'Initials': 'BW', 'LastName': 'Igl', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre and Duke University-National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Italian Association of Hospital Cardiologists (ANMCO) Research Centre, Florence, Italy.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1787']
392,31525580,Interrupting providers with clinical decision support to improve care for heart failure.,"BACKGROUND


Evidence-based therapy for heart failure remains underutilized at hospital discharge, particularly for patients with heart failure who are hospitalized for another cause. We developed clinical decision support (CDS) to recommend an angiotensin converting enzyme (ACE) inhibitor during hospitalization to promote its continuation at discharge. The CDS was designed to be implemented in both interruptive and non-interruptive versions.
OBJECTIVES


To compare the effectiveness and implementation of interruptive and non-interruptive versions of a CDS to improve care for heart failure.
METHODS


Hospitalizations of patients with reduced ejection fraction were pseudo-randomized to deliver interruptive or non-interruptive CDS alerts to providers based on even or odd medical record number. We compared discharge utilization of an ACE inhibitor or angiotensin receptor blocker (ARB) for these two implementation approaches. We also assessed adoption and implementation fidelity of the CDS.
RESULTS


Of 958 hospitalizations, interruptive alert hospitalizations had higher rates of discharge utilization of ACE inhibitors or ARBs than non-interruptive alert hospitalizations (79.6% vs. 74.2%, p = 0.05). Utilization was higher for interruptive alert versus non-interruptive alert hospitalizations which were principally for causes other than heart failure (79.8% vs. 73.4%; p = 0.05) but no difference was observed among hospitalizations with a principal heart failure diagnosis (85.9% vs.81.7%; p = 0.49). As compared to non-interruptive hospitalizations, interruptive alert hospitalizations were more likely to have had: an alert with any response (40.6% vs. 13.1%, p < 0.001), contraindications reported (33.1% vs 11.3%, p < 0.001), and an ACE inhibitor ordered within twelve hours of the alert (17.6% vs 10.3%, p < 0.01). The response rate for the interruptive alert was 1.7%, and a median (25 th , 75 th  percentile) of 14 (5,32) alerts were triggered per hospitalization.
CONCLUSIONS


A CDS implemented as an interruptive alert was associated with improved quality of care for heart failure. Whether the potential benefits of CDS in improving cardiovascular care were worth the high burden of interruptive alerts deserves further consideration. CLINICALTRIALS.
GOV IDENTIFIER


NCT02858674.",2019,Utilization was higher for interruptive alert versus non-interruptive alert hospitalizations which were principally for causes other than heart failure (79.8% vs. 73.4%; p = 0.05) but no difference was observed among hospitalizations with a principal heart failure diagnosis (85.9% vs.81.7%; p = 0.49).,"['Hospitalizations of patients with reduced ejection fraction were pseudo-randomized to', 'patients with heart failure who are hospitalized for another cause', 'Of 958 hospitalizations']","['angiotensin converting enzyme (ACE) inhibitor', 'ACE inhibitor or angiotensin receptor blocker (ARB', 'deliver interruptive or non-interruptive CDS alerts to providers based on even or odd medical record number', 'CDS']","['hospitalizations with a principal heart failure diagnosis', 'Utilization', 'response rate', 'quality of care for heart failure', 'discharge utilization of ACE inhibitors or ARBs']","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1301894', 'cui_str': 'Medical record number'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]",958.0,0.053978,Utilization was higher for interruptive alert versus non-interruptive alert hospitalizations which were principally for causes other than heart failure (79.8% vs. 73.4%; p = 0.05) but no difference was observed among hospitalizations with a principal heart failure diagnosis (85.9% vs.81.7%; p = 0.49).,"[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Blecker', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, United States; Department of Medicine, NYU School of Medicine, New York, NY, United States; Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, United States. Electronic address: Saul.blecker@nyumc.org.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Austrian', 'Affiliation': 'Department of Medicine, NYU School of Medicine, New York, NY, United States; Medical Center Information Technology, NYU Langone Health, New York, NY, United States.'}, {'ForeName': 'Leora I', 'Initials': 'LI', 'LastName': 'Horwitz', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, United States; Department of Medicine, NYU School of Medicine, New York, NY, United States; Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, United States.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Kuperman', 'Affiliation': 'Memorial Sloane Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, United States; Department of Medicine, NYU School of Medicine, New York, NY, United States.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Ferrauiola', 'Affiliation': 'Medical Center Information Technology, NYU Langone Health, New York, NY, United States.'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, NYU School of Medicine, New York, NY, United States.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2019.103956']
393,30872770,Safety and efficacy of intravitreal conbercept injection after vitrectomy for the treatment of proliferative diabetic retinopathy.,"BACKGROUND/OBJECTIVES


The aim of this study was to evaluate the safety and efficacy of intravitreal conbercept (a recombinant fusion protein that primarily targets vascular endothelial growth factors) after vitrectomy for the management of proliferative diabetic retinopathy without tractional retinal detachment (TRD).
SUBJECTS/METHODS


Fifty patients with non-clearing vitreous haemorrhage (VH) due to proliferative diabetic retinopathy without TRD were enroled. They were randomly divided into control and treatment groups (25 eyes to each group) after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not. The best corrected visual acuity (BCVA) and the central retinal thickness were measured.
RESULTS


There were no significant between-group differences in baseline characteristics (P > 0.05), except in age (P = 0.003). Improvement in BCVA was significantly greater at 1, 4, 12, and 24 weeks post surgery in the treatment group than it was in the control group (P < 0.001). There were more cases in the control group who developed recurrent VH, but the recurrence rate of VH was not significantly different between the two groups at 12 and 24 weeks post surgery (P = 0.192 and  0.103). Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks (P = 0.01), 12 weeks (P = 0.001), and 24 weeks (P = 0.004) post surgery, which were statistically significant.
CONCLUSIONS


An intravitreal injection of conbercept after vitrectomy improved visual acuity and seemed to reduce the recurrence of VH resulting in prompt visual recovery in the PDR patients.",2019,"Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks","['proliferative diabetic retinopathy', 'proliferative diabetic retinopathy without tractional retinal detachment (TRD', 'Fifty patients with non-clearing vitreous haemorrhage (VH) due to proliferative diabetic retinopathy without TRD were enroled']","['intravitreal conbercept (a recombinant fusion protein', 'intravitreal conbercept', 'intravitreal conbercept injection after vitrectomy']","['recurrence of VH', 'safety and efficacy', 'corrected visual acuity (BCVA) and the central retinal thickness', 'visual acuity', 'recurrent VH', 'recurrence rate of VH', 'BCVA', 'Central retinal thickness', 'Safety and efficacy']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0034857', 'cui_str': 'Recombinant Fusion Proteins'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",50.0,0.060211,"Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks","[{'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Shaochong', 'Initials': 'S', 'LastName': 'Bu', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Yuanfeng', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Liangzhang', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China. xiaorli@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0396-0']
394,32059705,Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial.,"BACKGROUND


Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches.
METHODS


This is a multicenter phase II study randomizing one hundred and forty patients with T1-2 N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50-60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity.
DISCUSSION


This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.",2020,"Secondary endpoints include progression free survival, QOL and toxicity.
","['one hundred and forty patients with T1-2\u2009N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60\u2009Gy)\u2009±\u2009concomitant chemotherapy and TOS\u2009±\u2009de-escalated', 'HPV-associated oropharyngeal squamous cell carcinoma with', 'Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC']","['adjuvant radiotherapy', 'radiotherapy vs. trans-oral surgery (ORATOR2', 'primary surgical approach (± adjuvant radiation) with transoral surgery (TOS', 'HPV+ OPC', 'primary radiotherapy (RT) approach (± concomitant chemotherapy']","['overall survival (OS', 'OS of each arm compared to historical control', 'survival, toxicity and quality of life (QOL) profiles', 'progression free survival, QOL and toxicity', 'toxicity', 'oncologic outcomes, QOL and toxicity']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}]",140.0,0.14419,"Secondary endpoints include progression free survival, QOL and toxicity.
","[{'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Pencilla', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Prisman', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berthelet', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonn', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': 'Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Goldstein', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Eskander', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Husain', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Bahig', 'Affiliation': 'Department of Radiation Oncology, CHUM, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Christopoulous', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, CHUM, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hier', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Sultanem', 'Affiliation': 'Department of Radiation Oncology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Richardson', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mlynarek', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Suren', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Corsten', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Rajaraman', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Johnson-Obaseki', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Department of Radiation Oncology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odell', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Shamir', 'Initials': 'S', 'LastName': 'Chandarana', 'Affiliation': 'Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Department of Radiation Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dort', 'Affiliation': 'Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'T Wayne', 'Initials': 'TW', 'LastName': 'Matthews', 'Affiliation': 'Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kerr', 'Affiliation': 'Department of Otolaryngology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dowthwaite', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Department of Radiation Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Audiology, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Wehrli', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Kwan', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada. david.palma@lhsc.on.ca.'}]",BMC cancer,['10.1186/s12885-020-6607-z']
395,31332449,Defibrillator charging before rhythm analysis causes peri-shock pauses exceeding guideline recommended maximum 5 s : A randomized simulation trial.,"INTRODUCTION


Charging defibrillators prior to analyzing heart rhythms may decrease the no-flow time during rhythm check pauses while resuscitating in cardiac arrest. Although this anticipatory method is already used in some centers little is known about its safety. This study was carried out to confirm the safety and feasibility of the anticipatory method. It was hypothesized that this anticipatory method results in shorter total no-flow times, while other parameters of defibrillation efficacy including defibrillator safety and minimization of peri-shock pauses are unchanged.
METHODS


This manikin study assigned 243 medical students randomly to study groups, 121 to the anticipatory method and 122 to the recommended European Resuscitation Council (ERC) algorithm. Of these 237 students ultimately underwent training (112 anticipatory method vs. 125 ERC algorithm). Participants were assessed and video recorded during a simulated cardiac arrest scenario which included three different heart rhythms (ventricular fibrillation [VF], pulseless ventricular tachycardia [pVT], asystole) in randomized order. Video and software analyses were performed. Defibrillation safety was assessed using a 17-item checklist defined beforehand.
RESULTS


A total of 203 simulated cardiac arrests (75 anticipatory method and 128 ERC 2010 algorithm) were analyzed. The anticipatory method did not significantly reduce no-flow time (25.8 s, standard deviation, SD 7.4 s vs. 27.4 s SD 8.4 s, p = 0.19); however, peri-shock pauses were significantly longer in the anticipatory group compared to the ERC 2010 group (9.5 s SD 2.8 s vs. 3.3 s SD 1.9 s, p < 0.001). No significant difference concerning defibrillation safety between the groups was observed according to the 17-item checklist (14.6 SD 1.6 vs. 15.0 SD 1.4, p = 0.07).
CONCLUSION


Charging defibrillators before rhythm analysis did not decrease total no-flow time in simulated cardiac arrests but resulted in significantly longer peri-shock pauses exceeding 5 s. No significant differences in defibrillation safety were observed between the groups.",2019,"The anticipatory method did not significantly reduce no-flow time (25.8 s, standard deviation, SD 7.4 s vs. 27.4 ","['237 students ultimately underwent training (112 anticipatory method vs. 125 ERC algorithm', '243 medical students randomly to study groups, 121 to the anticipatory method and 122 to the recommended European Resuscitation Council (ERC) algorithm']","['video recorded during a\xa0simulated cardiac arrest scenario which included three different heart rhythms (ventricular fibrillation [VF], pulseless ventricular tachycardia [pVT], asystole']","['total no-flow time', 'peri-shock pauses', 'Defibrillation safety', 'defibrillation safety', 'SD', 'defibrillation efficacy including defibrillator safety and minimization of peri-shock pauses', 'flow time', 'shorter total no-flow times']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0193504', 'cui_str': 'Endoscopic retrograde cholangiography (procedure)'}, {'cui': 'C0002045'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",2010.0,0.0257348,"The anticipatory method did not significantly reduce no-flow time (25.8 s, standard deviation, SD 7.4 s vs. 27.4 ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kemper', 'Affiliation': 'Institute of Emergency Medicine and Medical Management, LMU Munich, Munich, Germany. mkemper@ukaachen.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Emergency Medicine and Medical Management, LMU Munich, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lazarovici', 'Affiliation': 'Institute of Emergency Medicine and Medical Management, LMU Munich, Munich, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zwissler', 'Affiliation': 'Department of Anaesthesiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Prückner', 'Affiliation': 'Institute of Emergency Medicine and Medical Management, LMU Munich, Munich, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Meyer', 'Affiliation': 'Institute of Emergency Medicine and Medical Management, LMU Munich, Munich, Germany.'}]",Der Anaesthesist,['10.1007/s00101-019-0623-x']
396,31015198,Phase II Trial of Chemopreventive Effects of Levonorgestrel on Ovarian and Fallopian Tube Epithelium in Women at High Risk for Ovarian Cancer: An NRG Oncology Group/GOG Study.,"A large body of epidemiologic evidence has shown that use of progestin-containing preparations lowers ovarian cancer risk. The purpose of the current study was to gather further preclinical evidence supporting progestins as cancer chemopreventives by demonstrating progestin-activation of surrogate endpoint biomarkers pertinent to cancer prevention in the genital tract of women at increased risk of ovarian cancer. There were 64 women enrolled in a multi-institutional randomized trial who chose to undergo risk-reducing bilateral salpingo-oophorectomy (BSO) and to receive the progestin levonorgestrel or placebo for 4 to 6 weeks prior to undergoing BSO. The ovarian and fallopian tube epithelia (FTE) were compared immunohistochemically for effects of levonorgestrel on apoptosis (primary endpoint). Secondary endpoints included TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality. In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms. In the ovarian epithelium, treatment with levonorgestrel significantly decreased the proliferation index. The mean ovarian Ki-67 value in the placebo arm was 2.027 per 100 cells versus 0.775 per 100 cells in the levonorgestrel arm (two-sided  P  value via Mann-Whitney  U  test = 0.0114). The karyometric signature of nuclei in both the ovarian and FTE deviated significantly from normal controls (women at average risk of ovarian cancer), but was significantly less abnormal in women treated with levonorgestrel. These karyometric data further support the idea that progestins may clear genetically abnormal cells and act as chemopreventive agents against ovarian and fallopian tube cancer.",2019,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","['Women at High Risk for Ovarian Cancer', '64 women enrolled in a multi-institutional randomized trial who chose to']","['placebo', 'levonorgestrel', 'Levonorgestrel', 'progestin-containing preparations', 'undergo risk-reducing bilateral salpingo-oophorectomy (BSO', 'progestin levonorgestrel or placebo']","['ovarian and fallopian tube epithelia (FTE', 'Ovarian and Fallopian Tube Epithelium', 'proliferation index', 'TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality', 'mean ovarian Ki-67 value']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}]","[{'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.125864,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","[{'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois. grodriguez@northshore.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Oncology, Clinical trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute; Buffalo, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hunn', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Thaete', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Watkin', 'Affiliation': 'Department of Pathology, NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Basil', 'Affiliation': 'TriHealth Hospitals, Cincinnati, Ohio.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Lele', 'Affiliation': 'Gynecologic Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'Department of Mathematics, University of Arizona, Department of Mathematics, Phoenix, Arizona.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bartels', 'Affiliation': 'Department of Optical Sciences, University of Arizona, Optical Sciences, Phoenix, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0383']
397,31232891,Short Versus Long Cephalomedullary Nails for Pertrochanteric Hip Fractures: A Randomized Prospective Study.,"OBJECTIVE


To compare functional and clinical outcomes in patients with pertrochanteric hip fractures treated with either a short (SN) or long (LN) cephalomedullary nail.
DESIGN


Prospective, randomized.
SETTING


Clinical investigation was performed at the Mayo Clinic's Level 1 Trauma Center in Rochester, MN.
PATIENTS/PARTICIPANTS


Two hundred twenty patients with intertrochanteric fractures were prospectively randomized to an SN or LN cohort. A total of 168 patients (SN, n = 80; LN, n = 88) had a mean follow-up of 13.9 months. Fifty-two patients did not meet the minimum 3-month follow-up. Demographics were comparable between the cohorts.
MAIN OUTCOME MEASURES


The primary outcome measurement was functional outcome evaluated by Short Form (SF-36) and Harris Hip scores (HHS) at 3 months. Secondary outcomes included implant failure, peri-implant fracture, mortality, operative time, estimated blood loss, and reoperation.
RESULTS


SN and LN cohorts were comparable in all aspects of the SF-36. There was a clinically insignificant difference in the HHS between cohorts. Patients treated in the SN cohort experienced shorter operative times but did not differ in tip-to-apex distance or subtrochanteric fracture extension. There was no difference in implant cutout, deep surgical site infection, or peri-implant fractures.
CONCLUSIONS


Patients treated with SNs or LNs for pertrochanteric femur fractures experienced comparable functional outcomes as measured by SF-36 and HHS. When compared with the LN cohort, SN patients experienced no difference in peri-implant fracture or lag-screw cutout and tolerated up to 3 cm of subtrochanteric fracture line extension.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,Patients treated in the SN cohort experienced shorter operative times but did not differ in tip-to-apex distance or subtrochanteric fracture extension.,"['168 patients (SN, n=80; LN, n=88) had a mean follow-up of 13.9 months', 'Two-hundred and twenty patients with intertrochanteric fractures', 'patients with pertrochanteric hip fractures treated with either a short (SN) or long (LN) cephalomedullary nail', 'Pertrochanteric Hip Fractures', ""Clinical investigation was performed at the Mayo Clinic's Level 1 Trauma Center in Rochester, Minnesota""]","['SN or LN', 'Short versus Long Cephalomedullary Nails']","['functional outcome evaluated by Short Form (SF-36) and Harris Hip scores (HHS', 'implant failure, peri-implant fracture, mortality, operative time, estimated blood loss (EBL) and reoperation', 'peri-implant fracture or lag-screw cut-out and tolerated', 'implant cut-out, deep surgical site infection', 'shorter operative times']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C2717972', 'cui_str': 'Peri-Implant Fractures'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}]",220.0,0.0739998,Patients treated in the SN cohort experienced shorter operative times but did not differ in tip-to-apex distance or subtrochanteric fracture extension.,"[{'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Shannon', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Cross', 'Affiliation': ''}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Barlow', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Torchia', 'Affiliation': ''}, {'ForeName': 'Pamela K', 'Initials': 'PK', 'LastName': 'Holte', 'Affiliation': ''}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Sems', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001553']
398,30716790,A Multicentered Randomized Study on Early versus Rescue Calsurf Administration for the Treatment of Respiratory Distress Syndrome in Preterm Infants.,"OBJECTIVE


Surfactant and noninvasive ventilation are two major strategies for the treatment of neonates with respiratory distress syndrome (RDS). However, the optimal time for surfactant administering is yet controversial. This study compared the early and rescue Calsurf administration in preterm infants with RDS.
STUDY DESIGN


Preterm infants born between 26 0/7  and 32 6/7  weeks of gestation and needed nasal continuous positive airway pressure (nCPAP) immediately after birth were randomly assigned to the early or rescue Calsurf treatment group. In the early treatment group, neonates were intubated, administered surfactant with bag-mask ventilation, and extubated to nCPAP (INSURE [intubation-surfactant-extubation]). In the rescue treatment group, InSurE was given until the clinical manifestation and chest X-ray displayed RDS. The primary outcome was to compare the reintubation rate within 72 hour age between the two groups.
RESULTS


Among 305 neonates randomized to the early ( n  = 154) and rescue ( n  = 151) groups, the reintubation rate within 72 hours of age in these two groups did not differ significantly ( p >  0.05). The incidence of oxygen dependence until 36 weeks' corrected age was similar in both groups.
CONCLUSION


No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.",2019,No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.,"['305 neonates', 'neonates with respiratory distress syndrome (RDS', 'Respiratory Distress Syndrome in Preterm Infants', 'Preterm infants born between 26 0/7  and 32 6/7  weeks of gestation and needed nasal continuous positive airway pressure (nCPAP) immediately after birth', 'preterm infants with RDS']","['Surfactant and noninvasive ventilation', 'surfactant with bag-mask ventilation, and extubated to nCPAP (INSURE [intubation-surfactant-extubation', 'Rescue Calsurf Administration']","['incidence of oxygen dependence', 'reintubation rate']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",305.0,0.0830345,No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.,"[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Rong', 'Affiliation': 'Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ""Neonatal Intensive Care Unit, Huangshi Maternity and Children's Healthy Hospital, Huangshi, Hubei, China.""}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Neonatal Intensive Care Unit, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.""}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Neonatal Intensive Care Unit, Jingzhou Central Hospital, Jingzhou, Hubei, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Hubei University for Nationalities, Wuhan, Hubei, China.'}, {'ForeName': 'Qihong', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': ""Neonatal Intensive Care Unit, The First Affiliated Hospital of Yangtze University, The First People's Hospital of Jingzhou, Jingzhou, Hubei, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Neonatal Intensive Care Unit, The First Clinical Medical School of the Three Gorges University Yichang Central People's Hospital, Yichang, Hubei, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': 'Neonatal Intensive Care Unit, Xiangyang Central Hospital, Xiangyang, Hubei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': ""Neonatal Intensive Care Unit, The First People's Hospital of Tianmen, Tianmen, Hubei, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiao', 'Affiliation': ""Neonatal Intensive Care Unit, Hubei University of Medicine, Xiangyang No. 1 People's Hospital, Xiangyang, Hubei, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Neonatal Intensive Care Unit, Huanggang Central Hospital, Huanggang, Hubei, China.'}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Neonatal Intensive Care Unit, Hubei Maternal and Child Health Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Jijian', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Neonatal Intensive Care Unit, Taihe Hospital, Shiyan, Hubei, China.'}]",American journal of perinatology,['10.1055/s-0039-1678530']
399,31628465,Effects of Peptide YY on the Hypothalamic-Pituitary-Gonadal Axis in Healthy Men.,"CONTEXT


Central and peripheral administration of peptide YY (PYY) has potent anorectic effects, and PYY analogs are under development as antiobesity treatments. Recent animal data suggest PYY may also influence the reproductive axis; however the effects of PYY on the human reproductive system are unknown.
OBJECTIVE


To investigate the effects of PYY administration on the reproductive axis in healthy young men.
DESIGN


Single-blind, randomized, placebo-controlled crossover study.
SETTING


Clinical Research Facility, Imperial College Healthcare NHS Trust.
PARTICIPANTS


Eighteen healthy eugonadal men (mean age 24.1 ± 0.9 years, mean body mass index 22.2 ± 0.4 kg/m2).
INTERVENTION


Eight-hour intravenous infusion of 0.4 pmol/kg/min PYY3-36 or rate-matched vehicle infusion.
MAIN OUTCOME MEASURES


Number of luteinizing hormone (LH) pulses, LH, follicle stimulating hormone (FSH), and testosterone levels.
RESULTS


The number of LH pulses (mean number of LH pulses/8 hours: PYY 4.4 ± 0.3 vs vehicle 4.4 ± 0.4, P > .99), LH area under the curve (AUC) (PYY 1503 ± 79 IU.min/L vs vehicle 1574 ± 86 IU.min/L, P = .36), FSH AUC (PYY 1158 ± 513 IU.min/L vs vehicle 1199 ± 476 IU.min/L, P = .49) and testosterone AUC (PYY 10 485 ± 684 IU.min/L vs vehicle 11 133 ± 803 IU.min/L, P = .24) were similar during PYY and vehicle infusions.
CONCLUSIONS


Acute intravenous infusion of 0.4 pmol/kg/min PYY does not affect the reproductive axis in healthy men.",2020,PYY 4.4±0.3 vs vehicle,"['Eighteen healthy eugonadal men (mean age 24.1±0.9years, mean BMI 22.2±0.4kg/m2', 'healthy men', 'Healthy Men', 'healthy young men']","['Peptide-YY', 'placebo', '0.4pmol/kg/min PYY3-36 or rate-matched vehicle infusion']","['number of LH pulses', 'LH area under the curve (AUC', 'testosterone AUC', 'FSH AUC']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}]",18.0,0.314585,PYY 4.4±0.3 vs vehicle,"[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Yoshibye', 'Initials': 'Y', 'LastName': 'Crustna', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pratibha C', 'Initials': 'PC', 'LastName': 'Machenahalli', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Panayi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Starikova', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Risheka', 'Initials': 'R', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sykes', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Plumptre', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Coumbe', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wing', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pacuszka', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Minnion', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tharakan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veldhuis', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Minnesota.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz103']
400,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
401,32217051,Optimising subjective anterior eye grading precision.,"PURPOSE


To establish the optimum grading increment which ensured parity between practitioners while maximising clinical precision.
METHODS


Second year optometry students (n = 127, 19.5 ± 1.4 years, 55 % female) and qualified eye care practitioners (n = 61, 40.2 ± 14.8 years, 52 % female) had 30 s to grade each of bulbar, limbal and palpebral hyperaemia of the upper lid of 4 patients imaged live with a digital slit lamp under 16× magnification, diffuse illumination, with the image projected on a screen. The patients were presented in a randomised sequence 3 times in succession, during which the graders used the Efron printed grading scale once to the nearest 0.1 increment, once to nearest 0.5 increment and once to the nearest integer grade in a randomised order. Graders were masked to their previous responses.
RESULTS


For most grading conditions less than 20 % of clinicians showed a ≤0.1 difference in grade from the mean. In contrast, more than 50 % of the student graders and 40 % of experienced graders showed a difference in grade from the mean within 0.5 for all conditions under measurement. Student precision in grading was better with both 0.1 and 0.5 grading increments than grading to the nearest unit, except for limbal hyperaemia where they performed more accurately with 0.5 unit increment grading. Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
CONCLUSION


Although narrower interval scales maximise the ability to detect smaller clinical changes, the grading increment should not exceed one standard deviation of the discrepancy between measurements. Therefore, 0.5 grading increments are recommended for subjective anterior eye physiology grading (limbal, bulbar and palpebral redness).",2020,"Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
","['Second year optometry students (n\u2009=\u2009127, 19.5\u2009±\u20091.4 years, 55 % female) and qualified eye care practitioners (n\u2009=\u200961, 40.2\u2009±\u200914.8 years, 52 % female) had 30\u2009s to grade each of bulbar, limbal and palpebral hyperaemia of the upper lid of 4 patients imaged live with a digital slit lamp under 16× magnification, diffuse illumination, with the image projected on a screen']",[],"['limbal hyperaemia', 'Limbal grading precision', 'subjective anterior eye physiology grading (limbal, bulbar and palpebral redness', 'bulbar hyperaemia', 'palpebral hyperaemia']","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029147', 'cui_str': 'Optometry'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C1444591', 'cui_str': 'Diffuse illumination'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",[],"[{'cui': 'C0423193', 'cui_str': 'Limbal injection (finding)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0028853', 'cui_str': 'Visual Physiology'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}]",,0.0273566,"Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vianya-Estopa', 'Affiliation': 'Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK. Electronic address: marta.vianya@anglia.ac.uk.'}, {'ForeName': 'Manbir', 'Initials': 'M', 'LastName': 'Nagra', 'Affiliation': 'Optometry, University of Portsmouth, Portsmouth, UK. Electronic address: manbir.nagra@port.ac.uk.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'School of Biomedical Sciences, Ulster University, Coleraine, UK. Electronic address: ajs.cochrane@ulster.ac.uk.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Retallic', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: optomneil@outlook.com.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Dunning', 'Affiliation': 'Advanced Technology Centre, Bradford College, Bradford, UK. Electronic address: D.Dunning@bradfordcollege.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Terry', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, UK. Electronic address: TerryL1@cardiff.ac.uk.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Lloyd', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: aoife.lloydmckernan@dit.ie.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: j.s.w.wolffsohn@aston.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.006']
402,31743406,Instillation of 5% Povidone-Iodine Ophthalmic Drops Decreases the Respiratory Rate in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.,"PURPOSE


To investigate the effects of topical application of ophthalmic 5% povidone-iodine eye drops, which has been reported to cause apnea in spontaneously breathing children during general anesthesia.
METHODS


The authors conducted a randomized, controlled, single-blinded study comparing the effect of balanced salt solution eye drops and povidone-iodine eye drops on respiration in spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway. Fifty patients received balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops.
RESULTS


None of the control patients had a significant change in respiration. Thirty of the 50 (60%) povidone-iodine patients had a slowing of respiration within the first 6 breaths after eye drop instillation (P < .001). The median time of respiratory pause in those 30 patients was 18.5 seconds (range: 4.36 to 96.2 seconds). Among the povidone-iodine patients, children with a history of a prior tonsillectomy and adenoidectomy and/or bilateral myringotomy had a 7.2 times greater chance of experiencing a change in respiration after instillation of the povidone-iodine eye drops.
CONCLUSIONS


Topical application of 5% povidone-iodine eye drops causes a slowing and pause in spontaneous ventilation in a majority of children prior to strabismus surgery. This may represent activation of the diving reflex. [J Pediatr Ophthalmol Strabismus. 2019;56(6):378-382.].",2019,None of the control patients had a significant change in respiration.,"['Children Undergoing Strabismus Surgery', 'children prior to strabismus surgery', 'Fifty patients received', 'spontaneously breathing children during general anesthesia', 'patients, children with a history of a prior tonsillectomy and', 'spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway']","['povidone-iodine eye drops', 'povidone-iodine', 'adenoidectomy and/or bilateral myringotomy', 'Povidone-Iodine Ophthalmic Drops', 'ophthalmic 5% povidone-iodine eye drops', 'balanced salt solution eye drops and povidone-iodine eye drops', 'balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops']","['chance of experiencing a change in respiration', 'slowing of respiration', 'median time of respiratory pause', 'respiration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0087123', 'cui_str': 'Myringostomy'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",50.0,0.174816,None of the control patients had a significant change in respiration.,"[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rovner', 'Affiliation': ''}, {'ForeName': 'Bethany Jacobs', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Wester', 'Affiliation': ''}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Furse', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20190923-01']
403,32227554,"Targeting pulmonary capillary permeability to reduce lung congestion in heart failure: a randomized, controlled pilot trial.","AIMS


Lung congestion in patients with heart failure (HF) has traditionally been treated using interventions that reduce pulmonary capillary hydrostatic pressure. The transient receptor potential vanilloid 4 (TRPV4) channel regulates fluid transit across the pulmonary capillary-interface, and represents a novel target to reduce lung water, independent of pulmonary capillary hypertension. This pilot study examined the safety and potential efficacy of TRPV4 blockade as a novel treatment for HF.
METHODS AND RESULTS


In this randomized, double-blind, placebo-controlled crossover pilot trial, 11 subjects with chronic, compensated HF were treated with a novel TRPV4 antagonist (GSK2798745) or placebo. The primary endpoint was lung diffusing capacity for carbon monoxide (DL CO  ) after 7 days of treatment with GSK2798745 as compared to placebo. Secondary endpoints included additional diffusion parameters, spirometry and safety assessments. Compared to placebo, treatment with GSK2798745 resulted in a trend to improvement in DL CO  (placebo: -0.336 mL/mmHg/min; GSK2798745: +0.458 mL/mmHg/min; treatment difference: +0.793 mL/mmHg/min; 95% confidence interval: -0.925 to 2.512) that was not statistically significant. GSK2798745 was well-tolerated with no serious adverse events.
CONCLUSION


In this pilot trial, GSK2798745 was found to be safe and well-tolerated, with a trend toward improved gas transfer. Further investigation is warranted in larger studies to determine whether treatment with TRPV4 antagonists or alternative treatments targeting capillary permeability might be effective to improve lung congestion, pulmonary gas transfer and clinical status in patients with acute or chronic HF.",2020,"Compared to placebo, treatment with GSK2798745 resulted in a trend to improvement in DL CO  (placebo: -0.336 mL/mmHg/min; GSK2798745: +0.458 mL/mmHg/min; treatment difference: +0.793 mL/mmHg/min; 95% confidence interval: -0.925 to 2.512) that was not statistically significant.","['patients with acute or chronic HF', 'patients with heart failure (HF', 'heart failure', '11 subjects with chronic, compensated HF were treated with a']","['placebo', 'TRPV4 blockade', 'novel TRPV4 antagonist (GSK2798745) or placebo']","['additional diffusion parameters, spirometry and safety assessments', 'lung diffusing capacity for carbon monoxide (DL CO  ', 'safe and well-tolerated', 'DL CO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",11.0,0.357065,"Compared to placebo, treatment with GSK2798745 resulted in a trend to improvement in DL CO  (placebo: -0.336 mL/mmHg/min; GSK2798745: +0.458 mL/mmHg/min; treatment difference: +0.793 mL/mmHg/min; 95% confidence interval: -0.925 to 2.512) that was not statistically significant.","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Stewart', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Sprecher', 'Affiliation': 'GlaxoSmithKline Pharmaceutical Ltd., Collegeville, PA, USA.'}, {'ForeName': 'Yogesh N V', 'Initials': 'YNV', 'LastName': 'Reddy', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Obokata', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Goldsmith', 'Affiliation': 'Hennepin County Medical Centre, Minneapolis, MI, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Bart', 'Affiliation': 'Hennepin County Medical Centre, Minneapolis, MI, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oughton', 'Affiliation': 'GlaxoSmithKline Pharmaceutical Ltd., Collegeville, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fillmore', 'Affiliation': 'GlaxoSmithKline Pharmaceutical Ltd., Collegeville, PA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Behm', 'Affiliation': 'GlaxoSmithKline Pharmaceutical Ltd., Collegeville, PA, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1809']
404,32124520,Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.,"OBJECTIVE


To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.
DESIGN


The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.
METHODS


Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health.
MAIN OUTCOME MEASURES


The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.
RESULTS


Of the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.
CONCLUSION


Outcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.
TWEETABLE ABSTRACT


Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function and behaviour.",2020,"The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups.","['503 women with threatened preterm birth', 'child outcome at age 2.5-5.5 years', 'Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems, and general health', '426 women eligible for follow up', 'women with threatened preterm birth']","['nifedipine', 'nifedipine or atosiban']","['rate of healthy survival', 'neurodevelopment, executive function, behaviour, and general health', 'Abnormal development', 'composite of abnormal development', 'broad child neurodevelopment, executive function, behaviour and general health', 'child outcome', 'overall mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",503.0,0.145086,"The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups.","[{'ForeName': 'Tms', 'Initials': 'T', 'LastName': 'van Winden', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Klumper', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Tichelaar', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Naaktgeboren', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Nijman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'van Baar', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': 'Paediatrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Roseboom', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""Van't Hooft"", 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16186']
405,31863530,Contingency management treatment for methamphetamine use disorder in South Africa.,"INTRODUCTION AND AIMS


As South Africa, especially the Western Cape Province, faces an epidemic of methamphetamine use disorder, therapeutic approaches suited to the South African context are needed. This secondary analysis assessed retention and methamphetamine abstinence outcomes in response to an 8-week pilot contingency management (CM) intervention trial of neural correlates of methamphetamine abstinence, exploring sociodemographic and clinical differences between responders and non-responders.
DESIGN AND METHODS


Research participants provided thrice-weekly monitored urine samples, which were analysed by qualitative radioimmunoassay. The primary outcome for this analysis was therapeutic response, defined as abstinence from methamphetamine (≥23 of 24 possible methamphetamine-negative urine samples).
RESULTS


Data from 30 adults living in Cape Town, South Africa (34 ± 6.1 years of age, mean age ± SD, 21 men) were included. Sixty-three percent (12 men) were responders. In bivariate comparisons, baseline measurements showed fewer responders reported monthly household income ≥25 000+ South African Rand (ZAR; ~USD $1880; vs. ZAR < 25 000) than non-responders (15.8% vs. 63.6%; P = 0.007). Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2  = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2  = 6.84, P = 0.008).
DISCUSSION AND CONCLUSIONS


Therapeutic response in this study were comparable to those obtained with CM for methamphetamine use disorder in North America and Europe. Our findings suggest that CM may be a useful component of treatment strategies to boost retention and continuous abstinence from methamphetamine in Cape Town, South Africa. Larger efficacy studies are needed in this setting.",2020,"Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2  = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2  = 6.84, P = 0.008).
","['30 adults living in Cape Town, South Africa (34\u2009±\u20096.1\u2009years of age, mean age\u2009±\u2009SD, 21 men) were included', 'methamphetamine use disorder in South Africa', 'Sixty-three percent (12 men) were responders']",[],"['median body mass index', 'therapeutic response, defined as abstinence from methamphetamine (≥23 of 24 possible methamphetamine-negative urine samples', 'median years of education']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",30.0,0.228972,"Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2  = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2  = 6.84, P = 0.008).
","[{'ForeName': 'Chukwuemeka N', 'Initials': 'CN', 'LastName': 'Okafor', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dannatt', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ipser', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'van Nunen', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Marilyn T', 'Initials': 'MT', 'LastName': 'Lake', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, USA.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}]",Drug and alcohol review,['10.1111/dar.13019']
406,32022261,"A randomized, phase 1, placebo-controlled trial of APG-157 in oral cancer demonstrates systemic absorption and an inhibitory effect on cytokines and tumor-associated microbes.","BACKGROUND


Although curcumin's effect on head and neck cancer has been studied in vitro and in vivo, to the authors' knowledge its efficacy is limited by poor systemic absorption from oral administration. APG-157 is a botanical drug containing multiple polyphenols, including curcumin, developed under the US Food and Drug Administration's Botanical Drug Development, that delivers the active components to oromucosal tissues near the tumor target.
METHODS


A double-blind, randomized, placebo-controlled, phase 1 clinical trial was conducted with APG-157 in 13 normal subjects and 12 patients with oral cancer. Two doses, 100 mg or 200 mg, were delivered transorally every hour for 3 hours. Blood and saliva were collected before and 1 hour, 2 hours, 3 hours, and 24 hours after treatment. Electrocardiograms and blood tests did not demonstrate any toxicity.
RESULTS


Treatment with APG-157 resulted in circulating concentrations of curcumin and analogs peaking at 3 hours with reduced IL-1β, IL-6, and IL-8 concentrations in the salivary supernatant fluid of patients with cancer. Salivary microbial flora analysis showed a reduction in Bacteroidetes species in cancer subjects. RNA and immunofluorescence analyses of tumor tissues of a subject demonstrated increased expression of genes associated with differentiation and T-cell recruitment to the tumor microenvironment.
CONCLUSIONS


The results of the current study suggested that APG-157 could serve as a therapeutic drug in combination with immunotherapy.
LAY SUMMARY


Curcumin has been shown to suppress tumor cells because of its antioxidant and anti-inflammatory properties. However, its effectiveness has been limited by poor absorption when delivered orally. Subjects with oral cancer were given oral APG-157, a botanical drug containing multiple polyphenols, including curcumin. Curcumin was found in the blood and in tumor tissues. Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue. APG-157 is absorbed well, reduces inflammation, and attracts T cells to the tumor, suggesting its potential use in combination with immunotherapy drugs.",2020,"Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue.","['head and neck cancer', 'Subjects with oral cancer', '13 normal subjects and 12 patients with oral cancer', 'cancer subjects']","['APG-157', 'placebo', 'oral APG-157, a botanical drug containing multiple polyphenols, including curcumin', 'placebo-controlled']","['circulating concentrations of curcumin and analogs peaking at 3\xa0hours with reduced IL-1β, IL-6, and IL-8 concentrations', 'Blood and saliva', 'Electrocardiograms and blood tests', 'toxicity', 'Inflammatory markers and Bacteroides species', 'saliva, and immune T cells']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0005768'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",13.0,0.135396,"Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue.","[{'ForeName': 'Saroj K', 'Initials': 'SK', 'LastName': 'Basak', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alakesh', 'Initials': 'A', 'LastName': 'Bera', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Yoon', 'Affiliation': 'Pasarow Mass Spectrometry Laboratory, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Morselli', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Tosevska', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Russ', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Nasser', 'Affiliation': 'Department of Head and Neck Surgery, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Sajed', 'Affiliation': 'Department of Pathology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Mudgal', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Mehta', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Avila', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Faull', 'Affiliation': 'Pasarow Mass Spectrometry Laboratory, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Daniel Sanghoon', 'Initials': 'DS', 'LastName': 'Shin', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Eri S', 'Initials': 'ES', 'LastName': 'Srivatsan', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marilene B', 'Initials': 'MB', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}]",Cancer,['10.1002/cncr.32644']
407,30783259,Oral fluoxetine in the management of amblyopic patients aged between 10 and 40 years old: a randomized clinical trial.,"OBJECTIVE


The objective of this study is to assess the efficacy of oral fluoxetine therapy in improving the visual function of amblyopic patients aged between 10 and 40 years old.
METHODS


In this double-blinded, randomized, controlled trial (IRCT2016052428046N1; registered retrospectively), 40 eligible participants with anisometropic or mixed amblyopia were randomly assigned to either fluoxetine or placebo groups. Participants with anisometropia and logMAR best spectacle-corrected visual acuity (BSCVA) worse than 0.2 logMAR in the amblyopic eye or at least a two-line of difference in the BSCVA between the fellow eyes were included. Participants with significant ocular or systemic diseases were excluded. In both groups, the better eye of each patient was patched for 4-6 h a day during the study period. Participants in the treatment group were treated with oral fluoxetine for 3 months. Change in the Snellen BSCVA (after 3 months) was regarded as the primary outcome measure.
RESULTS


Data from 20 participants in the fluoxetine group and 15 participants from the placebo group were analyzed (aged 11-37 years). The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain).
CONCLUSIONS


This study suggests beneficial effects of fluoxetine in the management of adult and adolescent amblyopia.",2019,"The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain).
","['amblyopic patients aged between 10 and 40 years old', '40 eligible participants with anisometropic or mixed amblyopia', 'adult and adolescent amblyopia', 'Participants with significant ocular or systemic diseases were excluded', '20 participants in the fluoxetine group and 15 participants from the placebo group were analyzed (aged 11-37 years']","['oral fluoxetine', 'fluoxetine', 'Oral fluoxetine', 'fluoxetine therapy', 'fluoxetine or placebo']","['anisometropia and logMAR best spectacle-corrected visual acuity (BSCVA', 'visual acuity']","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",40.0,0.22094,"The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain).
","[{'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Sharif', 'Affiliation': 'Department of Physiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Talebnejad', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran. talebnejadmr@yahoo.com.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Rastegar', 'Affiliation': 'Department of Physiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khalili', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'M Hossein', 'Initials': 'MH', 'LastName': 'Nowroozzadeh', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Eye (London, England)",['10.1038/s41433-019-0360-z']
408,31822498,TBCRC 032 IB/II Multicenter Study: Molecular Insights to AR Antagonist and PI3K Inhibitor Efficacy in Patients with AR +  Metastatic Triple-Negative Breast Cancer.,"PURPOSE


Preclinical data demonstrating androgen receptor (AR)-positive (AR + ) triple-negative breast cancer (TNBC) cells are sensitive to AR antagonists, and PI3K inhibition catalyzed an investigator-initiated, multi-institutional phase Ib/II study TBCRC032. The trial investigated the safety and efficacy of the AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib in patients with metastatic AR +  (≥10%) breast cancer.
PATIENTS AND METHODS


Phase Ib patients [estrogen receptor positive (ER + ) or TNBC] with AR +  breast cancer received 160 mg enzalutamide in combination with taselisib to determine dose-limiting toxicities and the maximum tolerated dose (MTD). Phase II TNBC patients were randomized to receive either enzalutamide alone or in combination with 4 mg taselisib until disease progression. Primary endpoint was clinical benefit rate (CBR) at 16 weeks.
RESULTS


The combination was tolerated, and the MTD was not reached. The adverse events were hyperglycemia and skin rash. Overall, CBR for evaluable patients receiving the combination was 35.7%, and median progression-free survival (PFS) was 3.4 months. Luminal AR (LAR) TNBC subtype patients trended toward better response compared with non-LAR (75.0% vs. 12.5%,  P  = 0.06), and increased PFS (4.6 vs. 2.0 months,  P  = 0.082). Genomic analyses revealed subtype-specific treatment response, and novel  FGFR2  fusions and AR splice variants.
CONCLUSIONS


The combination of enzalutamide and taselisib increased CBR in TNBC patients with AR +  tumors. Correlative analyses suggest AR protein expression alone is insufficient for identifying patients with AR-dependent tumors and knowledge of tumor LAR subtype and AR splice variants may identify patients more or less likely to benefit from AR antagonists.",2020,"Luminal AR (LAR) TNBC subtype patients trended towards better response compared to non-LAR (75.0% vs. 12.5%, p=0.06), and increased PFS (4.6 vs. 2.0 months, p=0.082).","['Ib patients (ER+ or TNBC) with AR+ breast cancer', 'TNBC patients with AR+ tumors', 'patients with AR+ metastatic triple-negative breast cancer', 'patients with metastatic AR+ (≥10%) breast cancer', 'Phase II TNBC patients']","['enzalutamide', 'AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib', 'AR antagonist and PI3K inhibitor efficacy', 'androgen receptor (AR)-positive (AR', 'enzalutamide alone or in combination with 4 mg taselisib until disease progression']","['clinical benefit rate (CBR', 'median progression-free survival (PFS', 'tolerated and the MTD', 'PFS', 'safety and efficacy', 'hyperglycemia and skin rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4053731'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",,0.0152657,"Luminal AR (LAR) TNBC subtype patients trended towards better response compared to non-LAR (75.0% vs. 12.5%, p=0.06), and increased PFS (4.6 vs. 2.0 months, p=0.082).","[{'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lehmann', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee. j.pietenpol@vumc.org vandana.abramson@vumc.org brian.d.lehmann@vumc.org.'}, {'ForeName': 'Vandana G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee. j.pietenpol@vumc.org vandana.abramson@vumc.org brian.d.lehmann@vumc.org.'}, {'ForeName': 'Melinda E', 'Initials': 'ME', 'LastName': 'Sanders', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tufia C', 'Initials': 'TC', 'LastName': 'Haddad', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Poznak', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Nangia', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Paula I', 'Initials': 'PI', 'LastName': 'Gonzalez-Ericsson', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Sanchez', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kimberly N', 'Initials': 'KN', 'LastName': 'Johnson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Abramson', 'Affiliation': 'Department of Radiology and Radiological Sciences, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Sheau-Chiann', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Center for Quantitative Sciences, Division of Cancer Biostatistics, Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shyr', 'Affiliation': 'Center for Quantitative Sciences, Division of Cancer Biostatistics, Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Pietenpol', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2170']
409,31553945,Parent Perceptions on a Walking School Bus Program Among Low-Income Families: A Qualitative Study.,"BACKGROUND


The walking school bus (WSB) is a promising intervention to increase walking to school and physical activity in school-age children. The aim of this qualitative study was to assess parent perceptions of a WSB program that was part of a randomized controlled trial to inform future programs.
METHODS


The authors interviewed 45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route. The authors performed a qualitative analysis of the interview transcripts and coded interview segments into 4 broad categories as follows: facilitators, barriers, general positive sentiments, and proposals.
RESULTS


Most parents spoke of the benefits of the WSB program; in particular, parents frequently applauded exercise/physical health benefits. Of the barriers, the most frequently cited was time, with work schedule and commute changes leading some families to walk less frequently.
CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models. Parents made several suggestions to improve the program, including better recruitment methods, logistical improvements, and a platform for communicating with other parents.",2019,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","['school-age children', '45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route', 'Low-Income Families']",['walking school bus (WSB'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336816', 'cui_str': 'School bus, device (physical object)'}]",[],45.0,0.0365653,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Teller', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ''}, {'ForeName': 'Nasira', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Waite', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ickes', 'Affiliation': ''}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0637']
410,31464082,Prospective randomized comparison of tongue base resection techniques: Robotic vs coblation.,"OBJECTIVE


The objective of this study was to determine the effectiveness and morbidities of two different tongue base surgical approaches in patients with obstructive sleep apnoea (OSA).
DESIGN AND SETTING


We carried out a prospective analysis in order to understand in detail the relative impact on apnoeas of the two different tongue base procedures. Seventy cases in 85 patients with OSA were divided into two operating groups and randomized. Altogether, 37 transoral robotic surgeries (TORS) and 33 coblations were performed. The patency of retrolingual passage was investigated by Muller's manoeuvere, polysomnography. Apnoea-hypopnea index (AHI) was the primary outcome measure with the Epworth Sleepiness Score (ESS). The final follow-up visit was at 6 months.
RESULTS


The AHI index improved from 29.7 ± 9 to 10.7 ± 3.9 (P < .005) following TORS and from 27.2 ± 6.4 to 10.3 ± 4 in the coblation group. Selecting a threshold of a 50% reduction in AHI and AHI less than 20 events/h, the overall success rate was 75.6% in TORS compared with 78.7% in coblation (P = .785). Similar results were seen in AHI reduction rates (36%, 37.8%, respectively). ESS showed a significant improvement 6 months following surgery in both groups.
CONCLUSION


Transoral robotic surgery technique showed higher complication rates than coblation. TORS and coblation of the tongue base represent a promising treatment option with a similar AHI improvement. However, coblation promises lower complication rates unlike TORS.",2019,The AHI index improved from 29.7±9 to 10.7±3.9 (p<0.005) following TORS and from 27.2±6.4 to 10.3±4 in the coblation group.,"['patients with obstructive sleep apnea (OSA', 'Seventy cases in 85 patients with OSA']","['TORS technique', 'Tongue Base Resection Techniques: Robotic vs Coblation', 'ESS']","['effectiveness and morbidities', 'complication rates', 'AHI reduction rates', 'Apnea-hypopnea index (AHI', 'overall success rate', 'AHI index', 'patency of retrolingual passage', 'Epworth Sleepiness Score (ESS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",85.0,0.0398215,The AHI index improved from 29.7±9 to 10.7±3.9 (p<0.005) following TORS and from 27.2±6.4 to 10.3±4 in the coblation group.,"[{'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Babademez', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yildirim Beyazit University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Gul', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yildirim Beyazit University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mecit', 'Initials': 'M', 'LastName': 'Sancak', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yildirim Beyazit University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Hayati', 'Initials': 'H', 'LastName': 'Kale', 'Affiliation': ""Department of Otorhinolaryngology, Head and Neck Surgery, Dr. Sami Ulus Maternity, Children's Health and Diseases Training and Research Hospital, Ankara, Turkey.""}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13424']
411,32205677,Sprint and Strength Training Modulates Autophagy and Proteostasis in Aging Sprinters.,"PURPOSE


Exercise and aging may modulate muscle protein homeostasis and autophagy, but few studies examine highly trained middle-age or older individuals. This study elucidated the effects of a new long-term training stimulus on markers of muscle autophagy and unfolded protein response (UPR) and on sprint running performance in masters sprinters.
METHODS


Thirty-two male competitive sprinters (age 40-76 yr) were randomly divided into experimental (EX) and control (CTRL) groups. The EX training program was a combination of heavy and explosive strength and sprint exercises aimed at improving sprint performance. Fifteen and thirteen participants completed the 20-wk intervention period in EX and CTRL, respectively. The latter were told to continue their routine exercises. Key protein markers were analyzed by Western blotting from vastus lateralis (VL) muscle biopsies. The muscle thickness of VL was analyzed by ultrasonography and sprint performance by a 60-m running test.
RESULTS


EX induced improvement in 60-m sprint performance when compared with controls (time-group, P = 0.003) without changes in VL muscle thickness. Content of lipidated microtubule-associated protein 1A/1B-light chain 3 (LC3-II) increased in EX (P = 0.022), suggesting increased autophagosome content. In addition, an autophagosome clearance marker sequestosome 1 (p62) decreased in EX (P = 0.006). Markers of UPR selectively modulated with decreases (e.g., ATF4, P = 0.003) and increases (e.g., EIF2α, P = 0.019) observed in EX.
CONCLUSIONS


These findings suggest that a new intensive training stimulus that combines strength training with sprint training may increase muscle autophagosome content in a basal state without any evidence of impaired autophagosome clearance in masters sprinters. Simultaneously, the combined training may have a selective effect on the content of UPR signaling components.",2020,"RESULTS


EX induced improvement in 60-meter sprint performance when compared to controls (time x group, P = 0.003) without changes in VL muscle thickness.","['Thirty-two male competitive sprinters (aged 40-76 years', 'highly-trained middle-aged or older individuals', 'masters sprinters']","['experimental (EX) and control (CTRL', 'Sprint and Strength Training']","['Muscle thickness of VL', 'markers of muscle autophagy and unfolded protein response (UPR', '60-meter sprint performance', 'VL muscle thickness']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C1155342', 'cui_str': 'Unfolded Protein Response'}, {'cui': 'C0475209', 'cui_str': 'm'}]",32.0,0.01632,"RESULTS


EX induced improvement in 60-meter sprint performance when compared to controls (time x group, P = 0.003) without changes in VL muscle thickness.","[{'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'HentilÄ', 'Affiliation': '1Faculty of Sport and Health Sciences, Neuromuscular Research Center, University of Jyväskylä, Jyväskylä, FINLAND 2Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, FINLAND 3Department of Physiology, Faculty of Medicine, University of Helsinki, Helsinki, FINLAND 4Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}, {'ForeName': 'Juha J', 'Initials': 'JJ', 'LastName': 'Hulmi', 'Affiliation': ''}, {'ForeName': 'Eija K', 'Initials': 'EK', 'LastName': 'Laakkonen', 'Affiliation': ''}, {'ForeName': 'Juha P', 'Initials': 'JP', 'LastName': 'Ahtiainen', 'Affiliation': ''}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Suominen', 'Affiliation': ''}, {'ForeName': 'Marko T', 'Initials': 'MT', 'LastName': 'Korhonen', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002340']
412,32404169,"Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.","BACKGROUND


Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP.
METHODS


Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.
RESULTS


The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
CONCLUSION


This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.
TRIAL REGISTRATION


IRCT201606042027N6. Registration date: 2016-09-04.",2020,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","['patients undergoing RT for pelvic cancers', 'for pelvic malignancies', 'Pelvic Cancer patients', 'Forty-two patients receiving']","['external-beam radiotherapy (RT', 'radiotherapy', 'Aloe vera topical ointment', 'Aloe vera 3% or placebo topical ointment during radiotherapy', 'Aloe vera ointment', 'acute radiation-induced Proctitis by Aloe vera', 'placebo']","['RTOG acute toxicity criteria and psychosocial status', 'median lifestyle score', 'rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency', 'burden of systemic inflammation', 'fecal urgency', 'prevention of symptoms of ARP', 'symptom index for diarrhea', 'quantitative CRP', 'rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0991554', 'cui_str': 'Cutaneous ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",42.0,0.424109,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sahebnasagh', 'Affiliation': 'Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Epidemiology, Faculty of Medicine, Community medicine Department, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Lashkardoost', 'Affiliation': 'School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, I.R, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. salehifare@yahoo.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02935-2']
413,30214064,Increasing genomic literacy among adolescents.,"PURPOSE


Adolescents increasingly need to be ""genomics literate,"" and may engage more with video educational formats than traditional written formats. We conducted a pilot study to assess and compare the impact of two modes of education about genome sequencing (GS) on adolescents' genomic knowledge and genomic-related decisions.
METHODS


Using an online survey, 43 adolescents ages 14-17 years were randomly assigned to watch a video or read a pamphlet about GS. Measures included pre- and postintervention assessment of genomic knowledge, perceived utility of these materials for decisions about participating in genetic research, interest in receiving GS results, and overall satisfaction with these materials. Analyses described results for all participants and compared results between intervention groups.
RESULTS


Self-reported genomic knowledge increased overall (p < 0.001). Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038). More video group than pamphlet group participants expressed satisfaction with the material's understandability (45% vs. 29%) and suitability (91% vs. 76%). Interest in receiving personal GS results was significantly associated with being female (p = 0.01) and younger (14-15 years vs. 16-17 years) (p = 0.002).
CONCLUSION


A video format may be preferable for increasing genomic literacy among adolescents. Further research with adolescents is needed to better understand how gender and age may impact genomic decisions and preferences.",2019,Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038).,"['adolescents', '43 adolescents ages 14-17 years']","['video or read a pamphlet about GS', 'education about genome sequencing (GS']","['pre- and postintervention assessment of genomic knowledge, perceived utility of these materials for decisions about participating in genetic research, interest in receiving GS results, and overall satisfaction', 'Postintervention knowledge about GS limitations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0243064', 'cui_str': 'Genetic Research'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]",,0.0617862,Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038).,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Sabatello', 'Affiliation': 'Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics, Department of Psychiatry, Columbia University, New York, NY, USA. ms4075@columbia.edu.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'Sanderson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Appelbaum', 'Affiliation': 'Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics, Department of Psychiatry, Columbia University, New York, NY, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0275-2']
414,30214066,Use of a novel computerized decision aid for aneuploidy screening: a randomized controlled trial.,"PURPOSE


To assess whether knowledge following use of a decision aid (DA) for aneuploidy screening and testing is inferior to knowledge in women who saw a genetic counselor (GC) only.
METHODS


This is a randomized controlled noninferiority trial of pregnant women at ≤22 weeks. Women who were scheduled for GC were randomly allocated to use a DA before GC or to GC alone. The primary outcome was knowledge score, comparing women who had used the DA only to those who saw GC alone. Analysis was by intent to treat.
RESULTS


Between January and October 2017, 197 women were randomized, 105 to GC only and 92 to DA use before GC. Demographics and baseline knowledge were similar between groups. Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306). Decisional conflict was similar following completion of the DA to following GC only, but was reduced following completion of both the DA and GC compared with GC only (0.22 vs. 1.74, p = 0.003).
CONCLUSION


Knowledge surrounding aneuploidy screening in women who used a DA was not inferior to knowledge in women who underwent GC. Use of the DA in addition to GC reduced decisional conflict.",2019,"Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306).","['aneuploidy screening', 'pregnant women at ≤22 weeks', 'women who saw a genetic counselor (GC) only', 'Between January and October 2017, 197 women were randomized, 105 to GC only and 92 to DA use before GC', 'Women who were scheduled for GC']","['decision aid (DA', 'DA before GC or to GC alone']","['Decisional conflict', 'decisional conflict', 'Mean knowledge score', 'knowledge score']","[{'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",197.0,0.100846,"Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306).","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Carlson', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. laura_carlson@med.unc.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hardisty', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Hocutt', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Vargo', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Elysia', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gilmore', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Neeta L', 'Initials': 'NL', 'LastName': 'Vora', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0283-2']
415,32224987,Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia.,"Anxiety, mood disturbance, eating and sleep disorders, and dissatisfaction with body image are prevalent disorders in women with fibromyalgia. The authors of this study aimed to determine the effects of tryptophan (TRY) and magnesium-enriched (MG) Mediterranean diet on psychological variables (trait anxiety, mood state, eating disorders, self-image perception) and sleep quality in women with fibromyalgia ( n  = 22; 49 ± 5 years old). In this randomized, controlled trial, the participants were randomly assigned to the experimental group and the placebo group. The intervention group received a Mediterranean diet enriched with high doses of TRY and MG (60 mg of TRY and 60 mg of MG), whereas the control group received the standard Mediterranean diet. Pittsburgh Sleep Quality Questionnaire, Body Shape Questionnaire, State-Trait Anxiety Inventory (STAI), Profile of Mood States (POMS-29) Questionnaire, Eating Attitudes Test-26, and Trait Anxiety Inventory were completed before and 16 weeks after the intervention. Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006). This study concludes that tryptophan and magnesium-enriched Mediterranean diet reduced anxiety symptoms, mood disturbance, eating disorders, and dissatisfaction with body image but did not improve sleep quality in women with fibromyalgia.",2020,"Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006).","['women with fibromyalgia ( n  = 22; 49 ± 5 years old', 'Women with Fibromyalgia', 'women with fibromyalgia']","['Mediterranean diet enriched with high doses of TRY and MG (60 mg of TRY and 60 mg of MG', 'standard Mediterranean diet', 'Tryptophan and Magnesium-Enriched Mediterranean Diet', 'placebo', 'tryptophan and magnesium-enriched Mediterranean diet', 'tryptophan (TRY) and magnesium-enriched (MG) Mediterranean diet']","['Anxiety, mood disturbance, eating and sleep disorders, and dissatisfaction with body image', 'mean scores of trait anxiety', 'sleep quality', 'anxiety symptoms, mood disturbance, eating disorders, and dissatisfaction with body image', 'eating disorders', 'psychological variables (trait anxiety, mood state, eating disorders, self-image perception) and sleep quality', 'Pittsburgh Sleep Quality Questionnaire, Body Shape Questionnaire, State-Trait Anxiety Inventory (STAI), Profile of Mood States (POMS-29) Questionnaire, Eating Attitudes Test-26, and Trait Anxiety Inventory', 'self-image perception', 'mood disturbance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C2732632', 'cui_str': 'Poor body image'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451032', 'cui_str': 'Body shape questionnaire (assessment scale)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test (assessment scale)'}]",,0.121059,"Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Faculty of Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Jacobo Á', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Effort Physiology Laboratory Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Domingo J', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reche-García', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Leyva-Vela', 'Affiliation': 'Department of Health, Vinalopó University Hospital, 03293 Elche, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Nadal-Nicolás', 'Affiliation': 'Faculty of Medicine, Miguel Hernández University of Elche, 03202 Elche, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072227']
416,32005285,The impact of high frequency oscillatory ventilation on mortality in paediatric acute respiratory distress syndrome.,"BACKGROUND


High-frequency oscillatory ventilation (HFOV) use was associated with greater mortality in adult acute respiratory distress syndrome (ARDS). Nevertheless, HFOV is still frequently used as rescue therapy in paediatric acute respiratory distress syndrome (PARDS). In view of the limited evidence for HFOV in PARDS and evidence demonstrating harm in adult patients with ARDS, we hypothesized that HFOV use compared to other modes of mechanical ventilation is associated with increased mortality in PARDS.
METHODS


Patients with PARDS from 10 paediatric intensive care units across Asia from 2009 to 2015 were identified. Data on epidemiology and clinical outcomes were collected. Patients on HFOV were compared to patients on other modes of ventilation. The primary outcome was 28-day mortality and secondary outcomes were 28-day ventilator- (VFD) and intensive care unit- (IFD) free days. Genetic matching (GM) method was used to analyse the association between HFOV treatment with the primary outcome. Additionally, we performed a sensitivity analysis, including propensity score (PS) matching, inverse probability of treatment weighting (IPTW) and marginal structural modelling (MSM) to estimate the treatment effect.
RESULTS


A total of 328 patients were included. In the first 7 days of PARDS, 122/328 (37.2%) patients were supported with HFOV. There were significant differences in baseline oxygenation index (OI) between the HFOV and non-HFOV groups (18.8 [12.0, 30.2] vs. 7.7 [5.1, 13.1] respectively; p < 0.001). A total of 118 pairs were matched in the GM method which found a significant association between HFOV with 28-day mortality in PARDS [odds ratio 2.3, 95% confidence interval (CI) 1.3, 4.4, p value 0.01]. VFD was indifferent between the HFOV and non-HFOV group [mean difference - 1.3 (95%CI - 3.4, 0.9); p = 0.29] but IFD was significantly lower in the HFOV group [- 2.5 (95%CI - 4.9, - 0.5); p = 0.03]. From the sensitivity analysis, PS matching, IPTW and MSM all showed consistent direction of HFOV treatment effect in PARDS.
CONCLUSION


The use of HFOV was associated with increased 28-day mortality in PARDS. This study suggests caution but does not eliminate equivocality and a randomized controlled trial is justified to examine the true association.",2020,"From the sensitivity analysis, PS matching, IPTW and MSM all showed consistent direction of HFOV treatment effect in PARDS.
","['paediatric acute respiratory distress syndrome (PARDS', 'adult acute respiratory distress syndrome (ARDS', 'adult patients with ARDS', 'Patients with PARDS from 10 paediatric intensive care units across Asia from 2009 to 2015 were identified', 'paediatric acute respiratory distress syndrome', 'A total of 328 patients were included']","['high frequency oscillatory ventilation', 'High-frequency oscillatory ventilation (HFOV']","['VFD', '28-day mortality and secondary outcomes were 28-day ventilator- (VFD) and intensive care unit- (IFD) free days', 'HFOV with 28-day mortality in PARDS', 'IFD', 'baseline oxygenation index (OI', 'propensity score (PS) matching, inverse probability of treatment weighting (IPTW) and marginal structural modelling (MSM', '28-day mortality']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation (procedure)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",328.0,0.346265,"From the sensitivity analysis, PS matching, IPTW and MSM all showed consistent direction of HFOV treatment effect in PARDS.
","[{'ForeName': 'Judith Ju-Ming', 'Initials': 'JJ', 'LastName': 'Wong', 'Affiliation': ""Children's Intensive Care Unit, Department of Pediatric Subspecialties, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore. judith.wong.jm@singhealth.com.sg.""}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Saw Swee Hock School of Public Health, National University Health System, NUS Graduate School for Integrative Science and Engineering, National University of Singapore, 12 Science Drive 2, Singapore, 117549, Singapore.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': ""Pediatric Intensive Care Unit, Children's Hospital of Chongqing Medical University, 136 Zhongshan 2nd Rd, Yuzhong district, Chongqing, 400041, China.""}, {'ForeName': 'Nattachai', 'Initials': 'N', 'LastName': 'Anantasit', 'Affiliation': 'Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Phuc Huu', 'Initials': 'PH', 'LastName': 'Phan', 'Affiliation': ""National Children's Hospital, 18/879 La Thành, Láng Thượng, Đống Đa, Hanoi, Vietnam.""}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Phumeetham', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Suyun', 'Initials': 'S', 'LastName': 'Qian', 'Affiliation': ""Beijing Children's Hospital, Capital Medical University, 56 Nanlishi Rd, Xicheng District, Beijing, 100045, China.""}, {'ForeName': 'Jacqueline Soo May', 'Initials': 'JSM', 'LastName': 'Ong', 'Affiliation': ""Khoo Teck Puat-National University Children's Medical Institute, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.""}, {'ForeName': 'Chin Seng', 'Initials': 'CS', 'LastName': 'Gan', 'Affiliation': 'Department of Pediatrics, University of Malaya. Jalan Universiti, 50603, Wilayah Persekutuan, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Yek Kee', 'Initials': 'YK', 'LastName': 'Chor', 'Affiliation': 'Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Rujipat', 'Initials': 'R', 'LastName': 'Samransamruajkit', 'Affiliation': 'Critical Care Excellence Center, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University Bangkok, Bangkok, 10330, Thailand.'}, {'ForeName': 'Tsee Foong', 'Initials': 'TF', 'LastName': 'Loh', 'Affiliation': ""Children's Intensive Care Unit, Department of Pediatric Subspecialties, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Saw Swee Hock School of Public Health, National University Health System, NUS Graduate School for Integrative Science and Engineering, National University of Singapore, 12 Science Drive 2, Singapore, 117549, Singapore.'}, {'ForeName': 'Jan Hau', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Children's Intensive Care Unit, Department of Pediatric Subspecialties, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-2741-x']
417,32215700,Covariate adjusted reanalysis of the I-Preserve trial.,"BACKGROUND


The CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan.
AIMS


To re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes.
METHODS


Cox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables.
RESULTS


In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86-1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80-0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization.
CONCLUSION


Adjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.",2020,"In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke).",[],['placebo'],"['composite of cardiovascular death or HF hospitalization', 'primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.329686,"In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke).","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lorenzo-Almorós', 'Affiliation': 'Department of Internal Medicine. Renal, Vascular and Diabetes Laboratory, Instituto de Investigaciones Sanitarias Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Duarte', 'Affiliation': 'National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Cardiovascular Division, Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McKelvie', 'Affiliation': 'Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Service de Cardiologie, Hôpital Saint Joseph, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK. john.mcmurray@glasgow.ac.uk.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01632-x']
418,31468342,Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial.,"BACKGROUND


General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse.
OBJECTIVE


To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients.
DESIGN


Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057).
PARTICIPANTS


Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital.
INTERVENTIONS


Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition).
MAIN MEASURES


Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse.
KEY RESULTS


20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g = 1.49) and 3.0% (Hedge's g = 1.26) in the respective workshop only and apprenticeship conditions (p < 0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
CONCLUSIONS


Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances.
TRIAL REGISTRY


NCT01825057.",2019,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","['medical inpatients who misuse substances', 'substance misuse with general medical inpatients', 'Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital']","['implementing motivational interviewing', 'Implementing Motivational Interviewing', 'Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition']","['percent of patient statements within the interviews that indicated motivation for reducing substance misuse', 'interview for substance misuse and the integrity (adherence, competence) of the interviews']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0369919', 'cui_str': 'Reducing substances (substance)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0448512,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. steve.martino@yale.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joy S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Desan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B. Johnson School of Public Affairs, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05257-3']
419,32041720,Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa.,"AIMS


To report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.
METHODS


A prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.
RESULTS


Twenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as 'responders', demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.
CONCLUSION


This first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO.
TRIAL REGISTRATION NUMBERS


EudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).",2020,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"['cystoid macular oedema associated with retinitis pigmentosa', '30 eyes of 30 patients', 'patients with RP-CMO, effective at reducing CMT in 37.9% of patients', 'retinitis pigmentosa-associated cystoid macular oedema (RP-CMO']","['aflibercept', 'intravitreal aflibercept (Eylea) (ivA']","['safety and efficacy', 'Longer duration of CMO', 'CMT or visual acuity (VA) improvement']","[{'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",30.0,0.0970614,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"[{'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Strong', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'Primary Care and Public Health Sciences, Kings College London, London, UK.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Georgiou', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Simona Degli', 'Initials': 'SD', 'LastName': 'Esposti', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Kalitzeos', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Michaelides', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK michel.michaelides@ucl.ac.uk.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315152']
420,31495201,GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma.,"Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34 +  hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10 6  CD34 +  cells/kg are necessary, while transplants of ≥5-6 × 10 6  CD34 +  cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529.",2019,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days.,['autologous transplant in myeloma'],"['Granulocyte colony stimulating factor (G-CSF', 'BL-8040 plus G-CSF over placebo plus G-CSF', 'autologous-hematopoietic cell transplantation', 'BL-8040\xa0+\xa0G-CSF']",['hematopoietic recovery'],"[{'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C4521107', 'cui_str': 'BL-8040'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]",[],,0.113349,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days.,"[{'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Crees', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Stockerl-Goldstein', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Vainstein', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'Hemda', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0380']
421,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
422,32274890,Comparison of two skin temperature assessment methods after the application of topical revulsive products: Conductive iButton data logger system vs contact-free infrared thermometry.,"BACKGROUND


Skin temperature assessments comprise conductive and contact-free techniques. Comparison between conductive data loggers and contact-free thermometry after the application of revulsive products is scarce. This study aimed to compare iButton data loggers with an infrared thermometer after the application of two revulsive products. Secondly, the relation between skin temperature kinetics with skin's perfusion of microcirculation was investigated.
MATERIALS AND METHODS


Healthy females (n = 25) were randomly allocated to two groups, representing the products A and B. Skin temperature was measured with ""iButtons"" and an infrared pistol at baseline and up to 1 hour after application. Skin's perfusion of microcirculation was monitored with a laser speckle contrast imager.
RESULTS


Baseline ""iButton"" temperature values were significantly lower compared with infrared pistol values in both groups. After application of the products, skin temperature decreased as recorded with both devices followed by an increase to baseline values when measured with the pistol. The results obtained by the ""iButtons"" reached values above baseline in both products towards the end of the follow-up period. A moderate correlation was found between infrared pistol and ""iButton"" system in product A, with a weak negative correlation between skin's perfusion of microcirculation and temperature devices. For product B, the correlation between the devices was moderate and between skin's perfusion and temperature devices weak and positive.
CONCLUSION


Both devices produced similar kinetics, except at baseline, where they may differ as metallic loggers have been insufficiently adapted to skin temperature. Skin's perfusion of microcirculation could not explain skin temperature changes.",2020,"For product B, the correlation between the devices was moderate and between skin's perfusion and temperature devices weak and positive.
",['Healthy females (n\xa0=\xa025'],[],"['Baseline ""iButton"" temperature values', 'skin temperature']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",25.0,0.0531813,"For product B, the correlation between the devices was moderate and between skin's perfusion and temperature devices weak and positive.
","[{'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Stoop', 'Affiliation': 'Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Landquart, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Hohenauer', 'Affiliation': 'Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Landquart, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Aerenhouts', 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'André O', 'Initials': 'AO', 'LastName': 'Barel', 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Deliens', 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Clijsen', 'Affiliation': 'Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Landquart, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clarys', 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI),['10.1111/srt.12847']
423,32201990,Treatment and compliance with virtual reality and anaglyph-based training programs for convergence insufficiency.,"BACKGROUND


Convergence insufficiency may be treated by visual exercises designed to increase convergence while maintaining single, clear, binocular vision. However, compliance with treatment is problematic, as patients often cease treatment when symptoms start to improve and before treatment is complete. The purpose of the present study was to assess the feasibility of using gamification of vision training to: (a) treat convergence insufficiency; and (b) improve compliance to treatment in comparison to a conventional treatment over a six-week treatment period.
METHODS


Two interventions, anaglyphs and a virtual reality game of Snakes, were evaluated for their effectiveness in treating adults with convergence insufficiency. The prescribed training regimen was 20 minutes, three times per week for six weeks. Vision was assessed before and after the treatment period. Participants also filled in the Core Elements of the Gaming Experience Questionnaire to gauge impact of game design on compliance.
RESULTS


Eighteen participants (mean age 20.8 ± 1.8 years) met the inclusion criteria for convergence insufficiency and nine participants were randomly assigned to each intervention. Repeated measures analysis of variance showed a significant effect of visit for near point of convergence (F 1,16  = 38.32, p < 0.0001), near positive fusional reserves break (F 1,16  = 21.94, p < 0.0001) and recovery (F 1,16  = 26.87, p < 0.0001), but not of intervention type. Total time played was significantly longer for the virtual reality Snake Game than the anaglyph intervention (p < 0.0001), which translated to mean compliance of 82 per cent and 51 per cent respectively.
CONCLUSION


Gamification of vision training in a virtual reality environment is feasible and associated with increased compliance, hence may be a useful strategy to treat convergence insufficiency.",2020,"Total time played was significantly longer for the virtual reality Snake Game than the anaglyph intervention (p < 0.0001), which translated to mean compliance of 82 per cent and 51 per cent respectively.
","['Eighteen participants (mean age 20.8\u2009±\u20091.8\u2009years) met the inclusion criteria for convergence insufficiency and nine participants', 'adults with convergence insufficiency']","['virtual reality and anaglyph-based training programs', 'vision training']","['Total time played', 'recovery', 'Vision']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0271379', 'cui_str': 'Convergence Insufficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]",,0.0534035,"Total time played was significantly longer for the virtual reality Snake Game than the anaglyph intervention (p < 0.0001), which translated to mean compliance of 82 per cent and 51 per cent respectively.
","[{'ForeName': 'Mei Ying', 'Initials': 'MY', 'LastName': 'Boon', 'Affiliation': 'School of Optometry and Vision Science, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Asper', 'Affiliation': 'School of Optometry and Vision Science, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Peiting', 'Initials': 'P', 'LastName': 'Chik', 'Affiliation': 'School of Optometry and Vision Science, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Piranaa', 'Initials': 'P', 'LastName': 'Alagiah', 'Affiliation': 'School of Optometry and Vision Science, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Department of Computing, Macquarie University, Sydney, Australia.'}]",Clinical & experimental optometry,['10.1111/cxo.13057']
424,31391203,Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).,"OBJECTIVE


GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort.
RESEARCH DESIGN AND METHODS


Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine.
RESULTS


At baseline, GRADE's 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA 1c  of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m 2 , and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease).
CONCLUSIONS


The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.",2019,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","['Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed', 'requiring a second diabetes medication', '5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino', 'people with type 2 diabetes (T2DM', 'GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort', 'Diabetes', 'NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease']","['metformin monotherapy', 'metformin', 'glimepiride, sitagliptin, liraglutide, or insulin glargine']","['history of hypertension', 'history of heart attack or stroke']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",69.0,0.0711735,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA grademail@bsc.gwu.edu.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, MD.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Hermes J', 'Initials': 'HJ', 'LastName': 'Florez', 'Affiliation': 'University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hox', 'Affiliation': 'Pacific Health Research & Education Institute, Honolulu, HI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Underkofler', 'Affiliation': 'University of Colorado, Denver, Denver, CO.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0901']
425,32401286,Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.,"Importance


Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
Objective


To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
Design, Setting, and Participants


This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Interventions


Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Main Outcomes and Measures


Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Results


Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
Conclusions and Relevance


In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02314065.",2020,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"['Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50', '204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period', 'primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care', 'Health Anxiety']","['Face-to-face cognitive behavior therapy (CBT', 'internet-delivered CBT or to individual face-to-face CBT', 'Internet vs Face-to-Face Cognitive Behavior Therapy']","['initial symptom level, recruitment path, or patient treatment preference', 'health anxiety symptoms', 'net societal cost', '1-sided 95% CI upper limits', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.102247,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Björkander', 'Affiliation': 'Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0940']
426,32046418,An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis.,"Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.",2020,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","['women aged 14 to 49\xa0years', 'Bacterial Vaginosis', 'women with BV', 'adult women']","['placebo', 'secnidazole 2', 'Single-Dose Secnidazole', 'secnidazole']","['Bacterial vaginosis (BV', 'achievement of Nugent scores', 'clinical outcome responder rate', 'efficacy and safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074246', 'cui_str': 'secnidazole'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.140457,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pentikis', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA. helenpentikis@lupin.com.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Adetoro', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Tipping', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-019-00048-x']
427,32195768,Casein Ingestion Does Not Increase Muscle Connective Tissue Protein Synthesis Rates.,"PURPOSE


This study aimed to assess the effect of dietary protein ingestion on intramuscular connective tissue protein synthesis rates during overnight recovery from a single bout of resistance exercise.
METHODS


Thirty-six healthy, young males were randomly assigned to one of three treatments. One group ingested 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein before sleep (PRO, n = 12). The other two groups performed a bout of resistance exercise in the evening and ingested either placebo (EX, n = 12) or 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein before sleep (EX + PRO, n = 12). Continuous intravenous infusions of L-[ring-H5]-phenylalanine and L-[1-C]-leucine were applied, and blood and muscle tissue samples were collected to assess connective tissue protein synthesis rates and dietary protein-derived amino acid incorporation in the connective tissue protein fraction.
RESULTS


Resistance exercise resulted in higher connective tissue protein synthesis rates when compared with rest (0.086 ± 0.017%·h [EX] and 0.080 ± 0.019%·h [EX + PRO] vs 0.059 ± 0.016%·h [PRO]; P < 0.05). Postexercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared with postexercise placebo ingestion (P = 1.00). Dietary protein-derived amino acids were incorporated into the connective tissue protein fraction at rest, and to a greater extent during recovery from exercise (P = 0.002).
CONCLUSION


Resistance exercise increases intramuscular connective tissue protein synthesis rates during overnight sleep, with no further effect of postexercise protein ingestion. However, dietary protein-derived amino acids are being used as precursors to support de novo connective tissue protein synthesis.",2020,Post-exercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared to post-exercise placebo ingestion (P=1.00).,"['Thirty-six healthy, young males']","['Resistance exercise', 'bout of resistance exercise', 'placebo (EX, n=12) or 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein', 'dietary protein ingestion', 'Dietary protein-derived amino acids', 'L-[1-C]-phenylalanine-labeled casein protein', 'L-[ring-H5]-phenylalanine and L-[1-C]-leucine', 'Casein Ingestion']","['higher connective tissue protein synthesis rates', 'connective tissue protein synthesis rates']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0301698', 'cui_str': 'Connective tissue protein (substance)'}]",36.0,0.0150714,Post-exercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared to post-exercise placebo ingestion (P=1.00).,"[{'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Trommelen', 'Affiliation': '1NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, THE NETHERLANDS 2Top Institute Food and Nutrition (TIFN), Wageningen, THE NETHERLANDS.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': ''}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Senden', 'Affiliation': ''}, {'ForeName': 'Joy P B', 'Initials': 'JPB', 'LastName': 'Goessens', 'Affiliation': ''}, {'ForeName': 'Janneau', 'Initials': 'J', 'LastName': 'VAN Kranenburg', 'Affiliation': ''}, {'ForeName': 'Annemie P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': ''}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': ''}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002337']
428,31371315,A prospective trial of adjuvant therapy for high-risk uveal melanoma: assessing 5-year survival outcomes.,"BACKGROUND/AIMS


Survival after diagnosis of metastasis from uveal melanoma is poor. Identifying individuals at high risk for metastasis and developing adjuvant therapy to prevent clinically apparent metastasis could improve survival. We conducted an adjuvant trial of sequential, low-dose dacarbazine (DTIC) and interferon-alpha-2b (IFN-α-2b) in patients with cytogenetic high-risk uveal melanoma.
METHODS


Patients diagnosed with iris, ciliary body or choroidal melanoma with high-risk tumour cytogenetics (monosomy 3) were offered adjuvant treatment with low-dose DTIC and IFN-α-2b following primary therapy. Eligible but not enrolled patients were observed for comparison. DTIC was administered at 850 mg/m 2  intravenously on days 1 and 28. IFN-α-2b was administered at 3 million units three times a week subcutaneously for 24 weeks beginning at week 9. Hepatic imaging was performed prior to adjuvant therapy and then at least every 6 months. Survival data were collected for 5 years after enrolment.
RESULTS


33 patients (22%) were enrolled (treatment group), 29 (19%) were eligible but did not enrol (observation group) and 88 (59%) were not eligible. The 5-year metastasis-free survival (MFS) was 64%±9% for treated and 33%±10% for observed patients (p=0.05). The 5-year overall survival (OS) rate was 66%±9% for treated and 37%±10% for observed patients (p=0.02).
CONCLUSIONS


When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS). Differences in baseline tumour characteristics between treated and observed patients can influence interpretation of results.
TRIAL REGISTRATION NUMBER


NCT01100528.",2020,"When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS).","['Patients diagnosed with iris, ciliary body or choroidal melanoma with high-risk tumour cytogenetics (monosomy 3', 'patients with cytogenetic high-risk uveal melanoma', 'high-risk uveal melanoma', '33 patients (22%) were enrolled (treatment group), 29 (19%) were eligible but did not enrol (observation group) and 88 (59%) were not eligible']","['IFN-α-2b', 'adjuvant therapy', 'dacarbazine (DTIC) and interferon-alpha-2b (IFN-α-2b']","['Survival data', '5-year overall survival (OS) rate', '5-year metastasis-free survival (MFS', '5-year survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0008779', 'cui_str': 'Corpus Ciliare'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0475283', 'cui_str': 'High risk tumor (tumor staging)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0026499', 'cui_str': 'Monosomy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",33.0,0.505542,"When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS).","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Binkley', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Pierre L', 'Initials': 'PL', 'LastName': 'Triozzi', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rybicki', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Achberger', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Aldrich', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA singha@ccf.org.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314461']
429,32406162,Efficacy of microneedling plus topical 4% tranexamic acid solution vs 4% hydroquinone in the treatment of melasma: A single-blind randomized clinical trial.,"BACKGROUND


There are various treatment modalities for melasma, but none of them are effective on dermal component of melasma.
AIMS


In this study, we decided to evaluate the efficacy of microneedling plus tranexamic acid in comparison with 4% hydroquinone in the treatment of melasma.
METHODS


This is a single-blind randomized clinical trial on 70 participants with 14% dropout, and therefore, 60 patients with melasma completed the study. Patients were randomized based on simple randomization in 2 groups of A (microneedling plus topical 4% tranexamic acid, monthly) and B (topical 4% hydroquinone, nightly). Evaluation of mean MASI score, patient and physician assessments was performed at 4th, 8th and12th weeks of the treatment. Statistical analysis was performed by paired t test, chi-square test and Fisher's exact test, respectively.
RESULTS


Sixty women (30 patients in each group) were completed the study. Mean MASI score in group A was significantly lower at the end of the treatment (6.84 ± 4.31) than at the baseline (12.89 ± 5.16) (P < .01). Mean MASI score in group B was significantly lower at the end of the treatment (7.16 ± 4.38) than at the baseline (13.56 ± 4.88) (P < .01). There was no statistical difference between 2 groups regarding MASI score, physician and patient assessments during the treatment. Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
CONCLUSION


In our study, the combination of microneedling with tranexamic acid did not differ from 4% hydroquinone in the treatment of melasma.",2020,"Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
","['Sixty women (30 patients in each group) were completed the study', 'melasma', '70 participants with 14% dropout, and therefore, 60 patients with melasma completed the study']","['hydroquinone', 'microneedling plus topical 4% tranexamic acid solution vs 4% hydroquinone', 'A (microneedling plus topical 4% tranexamic acid, monthly) and B (topical 4% hydroquinone, nightly', 'microneedling plus tranexamic acid', 'tranexamic acid']","['Percentage of patient satisfaction', 'physician satisfaction', 'MASI score, physician and patient assessments', 'mean MASI score, patient and physician assessments', 'Mean MASI score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",70.0,0.118763,"Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Shamsi Meymandi', 'Affiliation': 'Pathology and Stem Cell Research Center, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Mozayyeni', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Manzumeh', 'Initials': 'M', 'LastName': 'Shamsi Meymandi', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Aflatoonian', 'Affiliation': 'Pathology and Stem Cell Research Center, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13392']
430,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
431,32152146,Genistein stimulates insulin sensitivity through gut microbiota reshaping and skeletal muscle AMPK activation in obese subjects.,"OBJECTIVE


Obesity is associated with metabolic abnormalities, including insulin resistance and dyslipidemias. Previous studies demonstrated that genistein intake modifies the gut microbiota in mice by selectively increasing  Akkermansia muciniphila , leading to reduction of metabolic endotoxemia and insulin sensitivity. However, it is not known whether the consumption of genistein in humans with obesity could modify the gut microbiota reducing the metabolic endotoxemia and insulin sensitivity.
RESEARCH DESIGN AND METHODS


45 participants with a Homeostatic Model Assessment (HOMA) index greater than 2.5 and body mass indices of ≥30 and≤40 kg/m 2  were studied. Patients were randomly distributed to consume (1) placebo treatment or (2) genistein capsules (50 mg/day) for 2 months. Blood samples were taken to evaluate glucose concentration, lipid profile and serum insulin. Insulin resistance was determined by means of the HOMA for insulin resistance (HOMA-IR) index and by an oral glucose tolerance test. After 2 months, the same variables were assessed including a serum metabolomic analysis, gut microbiota, and a skeletal muscle biopsy was obtained to study the gene expression of fatty acid oxidation.
RESULTS


In the present study, we show that the consumption of genistein for 2 months reduced insulin resistance in subjects with obesity, accompanied by a modification of the gut microbiota taxonomy, particularly by an increase in the Verrucomicrobia phylum. In addition, subjects showed a reduction in metabolic endotoxemia and an increase in 5'-adenosine monophosphate-activated protein kinase phosphorylation and expression of genes involved in fatty acid oxidation in skeletal muscle. As a result, there was an increase in circulating metabolites of β-oxidation and ω-oxidation, acyl-carnitines and ketone bodies.
CONCLUSIONS


Change in the gut microbiota was accompanied by an improvement in insulin resistance and an increase in skeletal muscle fatty acid oxidation. Therefore, genistein could be used as a part of dietary strategies to control the abnormalities associated with obesity, particularly insulin resistance; however, long-term studies are needed.",2020,"In addition, subjects showed a reduction in metabolic endotoxemia and an increase in 5'-adenosine monophosphate-activated protein kinase phosphorylation and expression of genes involved in fatty acid oxidation in skeletal muscle.","['45 participants with a Homeostatic Model Assessment (HOMA) index greater than 2.5 and body mass indices of ≥30\u2009and≤40\u2009kg/m 2  were studied', 'subjects with obesity', 'obese subjects']","['genistein', 'Genistein', 'placebo treatment or (2) genistein capsules']","['metabolic endotoxemia', 'Insulin resistance', 'glucose concentration, lipid profile and serum insulin', 'HOMA for insulin resistance (HOMA-IR) index', 'gene expression of fatty acid oxidation', 'insulin resistance', 'circulating metabolites of β-oxidation and ω-oxidation, acyl-carnitines and ketone bodies', 'serum metabolomic analysis, gut microbiota, and a skeletal muscle biopsy', 'skeletal muscle fatty acid oxidation']","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0202110', 'cui_str': 'Ketone bodies measurement, quantitative (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",45.0,0.0255813,"In addition, subjects showed a reduction in metabolic endotoxemia and an increase in 5'-adenosine monophosphate-activated protein kinase phosphorylation and expression of genes involved in fatty acid oxidation in skeletal muscle.","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Guevara-Cruz', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Einar T', 'Initials': 'ET', 'LastName': 'Godinez-Salas', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Sanchez-Tapia', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Torres-Villalobos', 'Affiliation': 'Cirugía Experimental, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Pichardo-Ontiveros', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Guizar-Heredia', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Arteaga-Sanchez', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Gamba', 'Affiliation': 'Nefrología, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Mojica-Espinosa', 'Affiliation': 'Unidad de Microarreglos, Instituto Nacional de Medicina Genómica, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Schcolnik-Cabrera', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Granados', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'López-Barradas', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Vargas-Castillo', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Torre-Villalvazo', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Lilia G', 'Initials': 'LG', 'LastName': 'Noriega', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Nimbe', 'Initials': 'N', 'LastName': 'Torres', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico.'}, {'ForeName': 'Armando R', 'Initials': 'AR', 'LastName': 'Tovar', 'Affiliation': 'Fisiologia de la Nutricion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico tovar.ar@gmail.com.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000948']
432,32019428,Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods.,"RATIONALE


Obstructive sleep apnea is common among patients with acute ischemic stroke and is associated with reduced functional recovery and an increased risk for recurrent vascular events.
AIMS AND/OR HYPOTHESIS


The Sleep for Stroke Management and Recovery Trial (Sleep SMART) aims to determine whether automatically adjusting continuous positive airway pressure (aCPAP) treatment for obstructive sleep apnea improves clinical outcomes after acute ischemic stroke or high-risk transient ischemic attack.
SAMPLE SIZE ESTIMATE


A total of 3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome.
METHODS AND DESIGN


Sleep SMART is a phase III, multicenter, prospective randomized, open, blinded outcome event assessed controlled trial. Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test. Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea proceed to a run-in night of aCPAP. Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months. Telemedicine is used to monitor and facilitate aCPAP adherence remotely.
STUDY OUTCOMES


Two separate primary outcomes: (1) the composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery) at six- and three-month post-randomization, respectively.
DISCUSSION


Sleep SMART represents the first large trial to test whether aCPAP for obstructive sleep apnea after stroke/transient ischemic attack reduces recurrent vascular events or death, and improves functional recovery.",2020,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"['Subjects with use (≥4\u2009h) of aCPAP and without development of significant central apneas', 'Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea', 'Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test', '3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome', 'patients with acute ischemic stroke', 'Sleep SMART']","['aCPAP', 'aCPAP plus usual care or care-as-usual for six months', 'Telemedicine', 'automatically adjusting continuous positive airway pressure (aCPAP) treatment']","['obstructive sleep apnea', 'composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery']","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3062.0,0.0612725,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"[{'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Division of Vascular Neurology and Division of Sleep Medicine, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Durmer', 'Affiliation': 'Nox Health, Johns Creek, GA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, UC Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Darin B', 'Initials': 'DB', 'LastName': 'Zahuranec', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Levine', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine and Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'H Klar', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'National Institutes of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Department of Neurology and Sleep Disorders Center, University of Michigan, Ann Arbor, MI, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020903979']
433,32201056,Changes in accommodative micro-fluctuations after wearing contact lenses of different optical designs.,"PURPOSE


Accommodative micro-fluctuations (AMF) are small dioptric changes during accommodation. The aim of this study was to evaluate and compare changes in AMF when wearing silicone hydrogel contact lenses of two different optical designs.
METHODS


A multi-centre, randomised, cross-over, non-dispensing study was conducted on 68 adapted contact lens wearers aged 25-35 years to compare AMF responses to a spherical and aspheric silicone hydrogel (comfilcon A) lens designs. A Righton Speedy ""i"" series Auto Refractometer in accommodation analyser mode was utilized before and after reading a standard text in font size 8 on an iPhone 5 for 20 min at a 25 cm viewing distance. Phone screen brightness was set by automatic adjustment mode and ambient illumination was controlled at all sites.
RESULTS


Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively. The difference was statistically significant (P = 0.017, Paired t-test).
CONCLUSIONS


The smaller change in AMF when using an aspheric lens design suggests reduced ciliary muscle stress when reading print on a smart phone at a close distance for short periods (20 min). Contact lens wearers who frequently use digital devices and are experiencing eye strain may benefit from switching from a spherical design to one that incorporates aspheric optics.",2020,"Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively.",['68 adapted contact lens wearers aged 25-35 years'],['spherical and aspheric silicone hydrogel (comfilcon A) lens designs'],"['accommodative micro-fluctuations', 'Mean\u2009±\u2009SD AMF change', 'ciliary muscle stress']","[{'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0559230', 'cui_str': 'Ciliary muscle structure (body structure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",68.0,0.0425713,"Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively.","[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kajita', 'Affiliation': 'Kajita Eye Clinic, Kyoei Building, 4F, 3-6-3, Shibaura, Minato-ku, Tokyo, Japan. Electronic address: Kajitamd1147@h5.dion.ne.jp.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Muraoka', 'Affiliation': 'CooperVision Japan, Inc., 2-36-13, Ebisu, Shibuya-Ku, Tokyo, Japan. Electronic address: Taku.Muraoka@jp.coopervision.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Orsborn', 'Affiliation': 'CooperVision Inc., San Ramon, CA, United States. Electronic address: GOrsborn@coopervision.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.003']
434,31240811,Enhanced smoking cessation support for newly abstinent smokers discharged from hospital (the Hospital to Home trial): a randomized controlled trial.,"BACKGROUND AND AIMS


The United Kingdom's National Institute for Health and Care Excellence guidance (NICE PH48) recommends that pharmacotherapy combined with behavioural support be provided for all smokers admitted to hospital; however, relapse to smoking after discharge remains common. This study aimed to assess the effect of adding home support for newly abstinent smokers to conventional NICE-recommended support in smokers discharged from hospital.
DESIGN


Individually randomized parallel group trial.
SETTING


One UK acute hospital.
PARTICIPANTS


A total of 404 smokers aged > 18 admitted to acute medical wards between June 2016 and July 2017 were randomized in equal numbers to each treatment group.
INTERVENTIONS AND COMPARATORS


The intervention provided 12 weeks of at-home cessation support, which included help in maintaining a smoke-free home, help in accessing and using medication, further behavioural support and personalized feedback on home air quality. The comparator was NICE PH48 care as usual.
MEASURES


The primary outcome was self-reported continuous abstinence from smoking validated by an exhaled carbon monoxide level < 6 parts per million 4 weeks after discharge from hospital.
FINDINGS


In an intention-to-treat analysis at the 4-week primary end-point, 38 participants (18.8%) in the usual care group and 43 (21.3%) in the intervention group reported continuous abstinence from smoking (odds ratio = 1.17, 95% confidence interval = 0.72 to 1.90, Bayes factor = 0.33). There were no significant differences in any secondary outcomes, including self-reported cessation at 3 months, having a smoke-free home or number of cigarettes smoked per day in those who did not quit.
CONCLUSIONS


Provision of a home visit and continued support to prevent relapse to smoking after hospital discharge did not appear to increase subsequent abstinence rate above usual care in accordance with UK guidance from the National Institute of Health and Care Excellence.",2019,"There were no significant differences in any secondary outcomes, including self-reported cessation at 3 months, having a smoke-free home, or number of cigarettes smoked per day in those who did not quit.
","['404 smokers aged >18 admitted to acute medical wards between June 2016 and July 2017', 'One UK acute hospital', 'newly abstinent smokers discharged from hospital (The Hospital to Home trial', 'smokers discharged from hospital', 'newly-abstinent smokers']","['home cessation support which included help in maintaining a smoke-free home, help in accessing and using medication, further behavioural support and personalised feedback']","['continuous abstinence from smoking', 'self-reported continuous abstinence from smoking validated by an exhaled carbon monoxide level', 'self-reported cessation at 3 months, having a smoke-free home, or number of cigarettes smoked']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}]",404.0,0.0870221,"There were no significant differences in any secondary outcomes, including self-reported cessation at 3 months, having a smoke-free home, or number of cigarettes smoked per day in those who did not quit.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Thorley', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}, {'ForeName': 'Blessing', 'Initials': 'B', 'LastName': 'Nyakutsikwa', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Opazo Breton', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Lewis', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14720']
435,31735108,"Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial.","PURPOSE


To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI).
MATERIALS AND METHODS


The Brave Dreams trial (  ClinicalTrials.gov  identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as ""favorable"" (n=38) or ""unfavorable"" (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared.
RESULTS


Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005).
CONCLUSION


Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.",2020,"Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66,","['chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients', 'Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS', 'MS patients with CCSVI', 'Multiple Sclerosis', '130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up']","['unfavorable', 'Venous Angioplasty', 'jugular vein flow restoration', 'magnetic resonance imaging (MRI', 'venography plus angioplasty (n=86) or venography']","['Cerebral Lesions', 'efficacy of jugular venoplasty', 'relative risks (RR', 'probability of being free of new cerebral lesions', 'likelihood of being free of new cerebral lesions']","[{'cui': 'C4511608', 'cui_str': 'CCSVI - chronic cerebrospinal venous insufficiency'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0455750', 'cui_str': 'Angioplasty of vein (procedure)'}, {'cui': 'C0022427', 'cui_str': 'Jugular Veins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",81.0,0.298585,"Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66,","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zamboni', 'Affiliation': 'HUB Center for Venous and Lymphatics Disorders of the Emilia Romagna Region, S. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galeotti', 'Affiliation': 'Unit of Interventional Radiology, S. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Salvi', 'Affiliation': 'IRCCS of the Neurosciences, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Giaquinta', 'Affiliation': 'Unit of Vascular Surgery and Transplantation, University of Catania, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Setacci', 'Affiliation': 'Unit of Vascular Surgery, University of Siena, Siena, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alborino', 'Affiliation': 'Unit of Radiology, Macerata Hospital, ASUR Marche, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Guzzardi', 'Affiliation': 'Unit of Interventional Radiology, Ospedale Maggiore, Novara, Italy.'}, {'ForeName': 'Salvatore J', 'Initials': 'SJ', 'LastName': 'Sclafani', 'Affiliation': 'Department of Radiology, New York State University in Brooklyn, New York, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna Center for Clinical Epidemiology, School of Medicine, University of Ferrara, Italy.'}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Veroux', 'Affiliation': 'Unit of Vascular Surgery and Transplantation, University of Catania, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819890110']
436,32187680,Optimizing the design of invasive placebo interventions in randomized controlled trials.,"BACKGROUND


Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs.
METHODS


A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics.
RESULTS


The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel.
CONCLUSION


DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.",2020,"Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.249571,"Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cousins', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tsang', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chalmers', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mardanpour', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}]",The British journal of surgery,['10.1002/bjs.11509']
437,31781714,"Healthy Heart Africa: a prospective evaluation of programme outcomes on individuals' hypertension awareness, screening, diagnosis and treatment in rural Kenya at 12 months.","OBJECTIVE


To evaluate the impact of Healthy Heart Africa (HHA), a comprehensive hypertension intervention programme, on hypertension awareness, knowledge, screening and diagnosis among rural communities in Kenya.
METHODS


Individuals from rural households near intervention and matched control healthcare facilities were randomly surveyed at baseline and the end point (after 12 months). A difference-in-differences analysis estimated the impact of HHA.
RESULTS


This analysis included 838 individuals (intervention, n = 432; control, n = 406) at baseline and 698 (n = 364 and n = 334, respectively) at the end point. At baseline, both groups had high hypertension awareness (> 80%) but poor knowledge. After 12 months, healthcare providers were the primary information source for the intervention group only (p < 0.05). At the end point, respondents' knowledge of hypertension risk factors, consequences and management trended higher among the intervention versus the control group. Hypertension screening/diagnosis and patient recall of provider recommendations remained unchanged in both groups.
CONCLUSIONS


HHA improved hypertension knowledge but screening and diagnosis remained unchanged after 12 months.",2020,"After 12 months, healthcare providers were the primary information source for the intervention group only (p < 0.05).","['Individuals from rural households near intervention and matched control healthcare facilities', 'Healthy Heart Africa', '838 individuals (intervention, n = 432; control, n = 406) at baseline and 698', ""individuals' hypertension awareness, screening, diagnosis and treatment in rural Kenya at 12 months"", 'rural communities in Kenya']",['Healthy Heart Africa (HHA'],"['Hypertension screening/diagnosis and patient recall of provider recommendations', 'high hypertension awareness', 'hypertension knowledge']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0740221', 'cui_str': 'Hypertension screening (procedure)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",838.0,0.0247572,"After 12 months, healthcare providers were the primary information source for the intervention group only (p < 0.05).","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Yonga', 'Affiliation': 'Aga Khan University, Nairobi, Kenya. Email: yongag@gmail.com.'}, {'ForeName': 'Francis O', 'Initials': 'FO', 'LastName': 'Okello', 'Affiliation': 'Abt Associates, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Herr', 'Affiliation': 'Abt Associates, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Ashling', 'Initials': 'A', 'LastName': 'Mulvaney', 'Affiliation': 'AstraZeneca, London, United Kingdom.'}, {'ForeName': 'Elijah N', 'Initials': 'EN', 'LastName': 'Ogola', 'Affiliation': 'Clinical Medicine and Therapeutics, University of Nairobi, Nairobi, Kenya.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-037']
438,32196954,Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.,"Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial. In part 2, the bioavailability of levocetirizine ODT without water was compared with that of levocetirizine IRT with water in the fasted state in 48 subjects; 47 subjects completed this part of the trial. Bioequivalence was demonstrated between levocetirizine IRT 5 mg and ODT 5 mg. The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.",2020,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","['Healthy Japanese Volunteers', '24 subjects', 'healthy Japanese male subjects consisting of 2 parts', '48 subjects; 47 subjects completed this part of the trial']","['levocetirizine ODT and levocetirizine IRT', 'levocetirizine ODT', 'Levocetirizine', 'Levocetirizine Oral Disintegrating Tablet', 'levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT', 'levocetirizine IRT']","['serious adverse events, deaths, or adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.011894,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hoyano', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakano', 'Affiliation': 'Immuno-Inflammation Therapeutic Office, Medicines Development, Japan Development, GlaxoSmithKline KK, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.791']
439,32162931,Modeling the suicidal behavior cycle: Understanding repeated suicide attempts among individuals with borderline personality disorder and a history of attempting suicide.,"OBJECTIVE


Suicide remains a leading cause of death in the United States, and recent reports have suggested the suicide rate is increasing. One of the most robust predictors of future suicidal behavior is a history of attempting suicide. Despite this, little is known about the factors that reduce the likelihood of reattempting suicide. This study compares theoretically derived suicide risk indicators to determine which factors are most predictive of future suicide attempts.
METHOD


We used data from a randomized, controlled trial comparing 3 forms of dialectical behavior therapy (DBT; Linehan et al., 2015). Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior. Assessments occurred at 4-month intervals throughout 1 year of treatment and 1 year of follow-up. Time-lagged generalized linear mixed models (GLMMs) were used to evaluate relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts.
RESULTS


Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study. Within-person variance in the time-lagged predictors was not associated with subsequent suicide attempts.
CONCLUSIONS


Among individuals with a recent suicide attempt, problem-focused coping and specific deficits in emotion regulation may differentiate those likely to reattempt from those who stop suicidal behavior during and after psychotherapy. These results suggest that treatments for recent suicide attempters should target increasing problem-focused coping and decreasing maladaptive emotion regulation skills. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"['individuals with borderline personality disorder and a history of attempting suicide', 'Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior']",['dialectical behavior therapy'],"['relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",,0.0736019,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"[{'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Kuehn', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Marsha M', 'Initials': 'MM', 'LastName': 'Linehan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Harned', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000496']
440,31919136,Predictive Blood-Based Biomarkers in Patients with Epithelial Ovarian Cancer Treated with Carboplatin and Paclitaxel with or without Bevacizumab: Results from GOG-0218.,"PURPOSE


GOG-0218, a double-blind placebo-controlled phase III trial, compared carboplatin and paclitaxel with placebo, bevacizumab followed by placebo, or bevacizumab followed by bevacizumab in advanced epithelial ovarian cancer (EOC). Results demonstrated significantly improved progression-free survival (PFS), but no overall survival (OS) benefit with bevacizumab. Blood samples were collected for biomarker analyses.
EXPERIMENTAL DESIGN


Plasma samples were analyzed via multiplex ELISA technology for seven prespecified biomarkers [IL6, Ang-2, osteopontin (OPN), stromal cell-derived factor-1 (SDF-1), VEGF-D, IL6 receptor (IL6R), and GP130]. The predictive value of each biomarker with respect to PFS and OS was assessed using a protein marker by treatment interaction term within the framework of a Cox proportional hazards model. Prognostic markers were identified using Cox models adjusted for baseline covariates.
RESULTS


Baseline samples were available from 751 patients. According to our prespecified analysis plan, IL6 was predictive of a therapeutic advantage with bevacizumab for PFS ( P  = 0.007) and OS ( P  = 0.003). IL6 and OPN were found to be negative prognostic markers for both PFS and OS ( P  < 0.001). Patients with high median IL6 levels (dichotomized at the median) treated with bevacizumab had longer PFS (14.2 vs. 8.7 months) and OS (39.6 vs. 33.1 months) compared with placebo.
CONCLUSIONS


The inflammatory cytokine IL6 may be predictive of therapeutic benefit from bevacizumab when combined with carboplatin and paclitaxel. Aligning with results observed in patients with renal cancer treated with antiangiogenic therapies, it appears plasma IL6 may also define those patients with EOC more or less likely to benefit from the addition of bevacizumab to standard chemotherapy.",2020,IL6 and OPN were found to be negative prognostic markers for both PFS and OS (p<0.001).,"['renal cancer patients', 'advanced epithelial ovarian cancer (EOC', 'epithelial ovarian cancer patients treated with']","['carboplatin and paclitaxel with placebo, bevacizumab followed by placebo, or bevacizumab followed by bevacizumab', 'placebo', 'bevacizumab', 'carboplatin and paclitaxel with or without bevacizumab', 'carboplatin and paclitaxel']","['median IL6 levels', 'overall survival (OS) benefit', 'longer PFS', 'biomarkers (IL6, Ang-2, osteopontin (OPN), stromal cell-derived factor-1 (SDF-1), VEGF-D, IL6 receptor (IL6R), and GP130', 'progression-free survival (PFS', 'IL6 and OPN']","[{'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0218504', 'cui_str': 'Chemokine (C-X-C Motif) Ligand 12'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",751.0,0.218524,IL6 and OPN were found to be negative prognostic markers for both PFS and OS (p<0.001).,"[{'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': 'Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bell Burdett', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tritchler', 'Affiliation': 'GOG Statistical and Data Center, Buffalo, New York.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Starr', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'J Chris', 'Initials': 'JC', 'LastName': 'Brady', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': ""Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Herbert I', 'Initials': 'HI', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'Division of Gynecology Oncology, Stephenson Cancer Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'Division of Gynecology Oncology, University of California Irvine Medical Center, Orange, California.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Gray', 'Affiliation': 'Division of Gynecology Oncology, Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jamie N', 'Initials': 'JN', 'LastName': 'Bakkum-Gamez', 'Affiliation': 'Division of Gynecology Oncology, Mayo Clinic, Byron, Minnesota.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boente', 'Affiliation': 'Minnesota Oncology, Minneapolis, Minnesota.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'GOG Statistical and Data Center, Buffalo, New York.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Division of Gynecologic Medical Oncology, Massachusetts General Hospital/Dana Farber Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina. anixon@duke.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0226']
441,32171308,Pain-related fear in adolescents with chronic musculoskeletal pain: process evaluation of an interdisciplinary graded exposure program.,"BACKGROUND


For studying the effectiveness of treatment, it is important to check whether a new treatment is performed as originally described in the study-protocol.
OBJECTIVES


To evaluate whether an interdisciplinary graded exposure program, for adolescents with chronic musculoskeletal pain reporting pain-related fear, was performed according to protocol, and whether it is feasible to implement the program in rehabilitation care.
METHODS


A process evaluation where quantitative and qualitative data on participant characteristics (adolescents, parents and therapists), attendance and participants' opinion on the program were collected, by means of registration forms, questionnaires and group interviews. To evaluate treatment fidelity, audio and video recordings of program sessions were analyzed.
RESULTS


Thirty adolescents were offered the program, of which 23 started the program. Adolescents attended on average 90% of the sessions. At least one parent per adolescent participated in the program. Analysis of 20 randomly selected recordings of treatment sessions revealed that treatment fidelity was high, since 81% of essential treatment elements were offered to the adolescents. The program was considered client-centered by adolescents and family-centered by parents. Treatment teams wished to continue offering the program in their center.
CONCLUSION


The interdisciplinary graded exposure program was performed largely according to protocol, and therapists, adolescents and their parents had a favorable opinion on the program. Implementation of the program in rehabilitation care is considered feasible.
TRIAL REGISTRATION


Clinicaltrials.gov ID: NCT02181725 (7 February 2014).",2020,"Analysis of 20 randomly selected recordings of treatment sessions revealed that treatment fidelity was high, since 81% of essential treatment elements were offered to the adolescents.","['adolescents with chronic musculoskeletal pain', ""participant characteristics (adolescents, parents and therapists), attendance and participants' opinion on the program were collected, by means of registration forms, questionnaires and group interviews"", 'Thirty adolescents', 'adolescents with chronic musculoskeletal pain reporting pain-related fear']",['interdisciplinary graded exposure program'],['Pain-related fear'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",30.0,0.022663,"Analysis of 20 randomly selected recordings of treatment sessions revealed that treatment fidelity was high, since 81% of essential treatment elements were offered to the adolescents.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dekker', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Universiteitssingel 40, 6229, ET, Maastricht, the Netherlands.'}, {'ForeName': 'J C M', 'Initials': 'JCM', 'LastName': 'van Haastregt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'J A M C F', 'Initials': 'JAMCF', 'LastName': 'Verbunt', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Universiteitssingel 40, 6229, ET, Maastricht, the Netherlands. jeanine.verbunt@maastrichtuniversity.nl.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'de Jong', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Universiteitssingel 40, 6229, ET, Maastricht, the Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van Meulenbroek', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Universiteitssingel 40, 6229, ET, Maastricht, the Netherlands.'}, {'ForeName': 'H F M', 'Initials': 'HFM', 'LastName': 'Pernot', 'Affiliation': 'Medicine, Laurentius Hospital Roermond, Roermond, the Netherlands.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'van Velzen', 'Affiliation': 'Revant Rehabilitation center, Breda, the Netherlands.'}, {'ForeName': 'C H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Department of Epidemiology, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'M E J B', 'Initials': 'MEJB', 'LastName': 'Goossens', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Functioning and Rehabilitation, Maastricht University, Universiteitssingel 40, 6229, ET, Maastricht, the Netherlands.'}]",BMC health services research,['10.1186/s12913-020-5053-6']
442,32179516,Effect of CETP inhibition with evacetrapib in patients with diabetes mellitus enrolled in the ACCELERATE trial.,"BACKGROUND


High-density lipoprotein (HDL) levels are inversely associated with cardiovascular risk. Cholesteryl ester transfer protein inhibition with evacetrapib results in a marked increase in HDL and reduction in low-density lipoprotein (LDL) levels. We evaluated the impact of treatment with evacetrapib versus placebo in the subset of 8236 patients with diabetes mellitus (DM) enrolled in the Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High Risk for Vascular Outcomes trial.
METHODS AND RESULTS


Time to first occurrence of any component of the primary composite endpoint of cardiovascular death, myocardial infarction, stroke, revascularization, and hospitalization for unstable angina was compared among patients with DM randomized to treatment with evacetrapib (n=4127) or placebo (n=4109) over a median of 26 months of follow-up. The mean baseline LDL at initiation was 80 mg/dL with a mean baseline HDL of 44 mg/dL. In patients with DM, evacetrapib resulted in a 131% mean increase in HDL levels and a 32% mean decrease in LDL at 3 months that was sustained during the course of the trial. At 6 months, hemoglobin A1c (HbA1c) levels were lower with evacetrapib than placebo (7.08% vs 7.15%, p=0.023). Composite event rates were higher in patients with DM than without DM (Kaplan-Meier estimates: 15.2% vs 10.6%, HR 1.46, 95% CI 1.30 to 1.64, p<0.001). In the DM group, event rates for the composite endpoint (14.5% evacetrapib vs 16% placebo, HR 0.95, 95% CI 0.85 to 1.07, p=0.38) and individual components of the composite were similar for both evacetrapib and placebo groups. No significant treatment interaction between treatment assignment and diabetes status was noted.
CONCLUSION


Despite a favorable increase in HDL, and decreases in LDL and HbA1c levels in patients with DM, we observed no benefits of treatment with evacetrapib on prespecified clinical outcomes in this high-risk population.",2020,"At 6 months, hemoglobin A1c (HbA1c) levels were lower with evacetrapib than placebo (7.08% vs 7.15%, p=0.023).","['in Patients at a High Risk for Vascular Outcomes trial', 'patients with diabetes mellitus enrolled in the ACCELERATE trial', '8236 patients with diabetes mellitus (DM', 'patients with DM']","['CETP inhibition with evacetrapib', 'placebo', 'evacetrapib', 'evacetrapib versus placebo', 'Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib']","['HDL levels', 'HDL', 'LDL', 'mean baseline LDL', 'low-density lipoprotein (LDL) levels', 'hemoglobin A1c (HbA1c) levels', 'LDL and HbA1c levels', 'cardiovascular death, myocardial infarction, stroke, revascularization, and hospitalization for unstable angina', 'Composite event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",8236.0,0.330549,"At 6 months, hemoglobin A1c (HbA1c) levels were lower with evacetrapib than placebo (7.08% vs 7.15%, p=0.023).","[{'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA menonv@ccf.org.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Divyang R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'St John', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Govinda', 'Initials': 'G', 'LastName': 'Weerakkody', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ruotolo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kathy E', 'Initials': 'KE', 'LastName': 'Wolski', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McErlean', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Cremer', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000943']
443,31083767,Effectiveness of an offer of the Smoke Free smartphone application for smoking cessation: protocol for a randomized controlled trial.,"BACKGROUND AND AIMS


Smartphone applications (apps) hold promise for delivering tobacco smoking cessation support to large numbers of people at low unit cost. Smoke Free is an evidence-informed, widely used app that is highly rated by users. This study aims to assess its effectiveness compared with no support.
DESIGN


Two-arm individually randomized controlled effectiveness trial.
SETTING


Online trial with no restrictions on location.
PARTICIPANTS


English-speaking smokers aged ≥ 18 years willing to make a quit attempt within 4 weeks from initial contact (n = 4990).
MEASUREMENTS


The primary outcome measure is self-reported 26-week continuous smoking abstinence. Secondary outcome measures include quit attempts in the first 4 weeks post-randomization, 12-week continuous smoking abstinence and 26-week continuous smoking abstinence among those who made a quit attempt.
COMMENTS


If it is effective, the Smoke Free smartphone app is an affordable and widely implementable intervention to help smokers to quit.",2019,"COMMENTS


If it is effective, the Smoke Free smartphone app is an affordable and widely implementable intervention to help smokers to quit.","['18\xa0years willing to make a quit attempt within 4\xa0weeks from initial contact (n\xa0=\xa04990', 'English-speaking smokers aged ≥']",['Smoke Free smartphone application'],"['self-reported 26-week continuous smoking abstinence', 'quit attempts in the first 4\xa0weeks post-randomization, 12-week continuous smoking abstinence and 26-week continuous smoking abstinence among those who made a quit attempt']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.130509,"COMMENTS


If it is effective, the Smoke Free smartphone app is an affordable and widely implementable intervention to help smokers to quit.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Jackson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14652']
444,32143655,"Effect of an ICU diary on psychiatric disorders, quality of life, and sleep quality among adult cardiac surgical ICU survivors: a randomized controlled trial.","BACKGROUND


Although studies on the effectiveness of the use of ICU diaries on psychiatric disorders and quality of life have been published, the results still seem to be controversial. The study aimed to determine the effects of using an ICU diary on psychiatric disorders, sleep quality, and quality of life (QoL) in adult ICU survivors in China.
METHODS


One hundred and twenty-six patients who underwent a scheduled cardiac surgery and were expected to stay ≥ 24 h in ICU were randomized to two groups (63 in each group). The patients in the intervention group received the use of ICU diaries during the period of post-ICU follow-up, while the patients in the control group received usual care without ICU diaries. The primary outcome was significant PTSD symptoms (Chinese version of Impact of Event Scale-Revised, IES-R; total score ≥ 35 was defined as significant PTSD symptoms) and its severity in patients 3 months post-ICU. The secondary outcomes included memories of the ICU at 1 month, QoL (Medical Outcomes Study 36-item Short-Form, SF-36), sleep quality (Pittsburgh Sleep Quality Index Questionnaire, PSQI), anxiety, and depression symptoms (Hospital Anxiety and Depression Scale, HADS) at 3 months.
RESULTS


Eighty-five and 83 patients completed the follow-up interviews at 1 month and 3 months post-ICU, respectively. Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the intervention group vs 9 of 42 (21.43%) in the control group (risk difference, - 9% [95% CI, - 2% to 21%], P = 0.10). There was no significant differences between groups in IES-R score, symptoms of intrusion, symptoms of avoidance, numbers of memories of feeling and delusional memories, SF-36 score and anxiety score (P > 0.05), while significant differences were found in symptom of hyperarousal score, numbers of factual memories and PSQI score (P < 0.05). No adverse effect was reported.
CONCLUSIONS


Using an ICU diary is not useful for preventing PTSD symptoms and anxiety symptoms and preserving the quality of life of the patients at 3 months post-ICU, while it significantly improves the survivor's factual memory of ICU and sleep quality, and prevents the hyperarousal symptom.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-IOR-16009109, registered on 28 August 2016.",2020,"Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the intervention group vs 9 of 42 (21.43%) in the control group (risk difference, - 9% [95% CI, - 2% to 21%], P = 0.10).","['One hundred and twenty-six patients who underwent a scheduled cardiac surgery and were expected to stay ≥\u200924\u2009h in ICU', 'adult cardiac', '28 August 2016', 'adult ICU survivors in China', 'surgical ICU survivors']","['ICU diaries', 'usual care without ICU diaries', 'ICU diary']","['psychiatric disorders, quality of life, and sleep quality', 'PTSD symptoms (Chinese version of Impact of Event Scale-Revised, IES-R; total score ≥\u200935 was defined as significant PTSD symptoms) and its severity', 'PTSD symptoms and anxiety symptoms', 'quality of life', ""survivor's factual memory of ICU and sleep quality"", 'memories of the ICU at 1\u2009month, QoL (Medical Outcomes Study 36-item Short-Form, SF-36), sleep quality (Pittsburgh Sleep Quality Index Questionnaire, PSQI), anxiety, and depression symptoms (Hospital Anxiety and Depression Scale, HADS', 'IES-R score, symptoms of intrusion, symptoms of avoidance, numbers of memories of feeling and delusional memories, SF-36 score and anxiety score', 'symptom of hyperarousal score, numbers of factual memories and PSQI score', 'Significant PTSD symptoms', 'adverse effect', 'psychiatric disorders, sleep quality, and quality of life (QoL']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0455743', 'cui_str': 'Delusional memories (finding)'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",126.0,0.0753974,"Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the intervention group vs 9 of 42 (21.43%) in the control group (risk difference, - 9% [95% CI, - 2% to 21%], P = 0.10).","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350122, China.'}, {'ForeName': 'Hui-Ning', 'Initials': 'HN', 'LastName': 'Xin', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Chung Lim Vico', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Liao', 'Affiliation': 'School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350122, China.'}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Li', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Na-Mei', 'Initials': 'NM', 'LastName': 'Xie', 'Affiliation': 'School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350122, China.'}, {'ForeName': 'Rong-Fang', 'Initials': 'RF', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350122, China. hulu2886@sina.com.'}]","Critical care (London, England)",['10.1186/s13054-020-2797-7']
445,32131802,Blood pressure after PREeclampsia/HELLP by SELF monitoring (BP-PRESELF): rationale and design of a multicenter randomized controlled trial.,"BACKGROUND


Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) or the Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) syndrome are associated with elevated cardiovascular disease (CVD) risks, but standardized prevention guidelines after such pregnancies are lacking. Hypertension is the first emerging risk factor after PE/HELLP pregnancies and is a major risk factor for CVD. Hypertension before the age of 55 years may lead to various manifestations of end-organ damage at relatively young age. Therefore, timely treatment of elevated blood pressure is mandatory, but many of these high-risk women have long-term undetected and untreated hypertension before adequate treatment is initiated.
AIM


The aim of our study is to assess whether home blood pressure monitoring (HBPM) in women with a previous PE/HELLP pregnancy is a valuable tool for the early detection of hypertension.
METHODS


Women with a history of both early and late PE/HELLP syndrome aged 40-60 years are invited to participate. Patients with a history of CVD, known hypertension and/or use of antihypertensive medication are excluded. Women are randomized between HPBM or 'usual care'. The primary outcome is feasibility and usability of HBPM after 1 year of follow-up. Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour. The results of this study will provide better strategies for timely detection and prevention of hypertension in women after PE/HELLP.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03228082. Registered June 15, 2017.",2020,"Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour.","['Patients with a history of CVD, known hypertension and/or use of antihypertensive medication are excluded', 'Women with a history of both early and late PE/HELLP syndrome aged 40-60\u2009years are invited to participate', 'women with a previous PE/HELLP pregnancy']",['home blood pressure monitoring (HBPM'],"['Blood pressure', 'feasibility and usability of HBPM', 'effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0162739', 'cui_str': 'Hemolysis, Elevated Liver Enzymes, Lowered Platelets'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1449681', 'cui_str': 'Blood Pressure Monitoring, Home'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",,0.183128,"Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour.","[{'ForeName': 'Hella E C', 'Initials': 'HEC', 'LastName': 'Muijsers', 'Affiliation': 'Department of Cardiology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. Hella.Muijsers@radboudumc.nl.'}, {'ForeName': 'Olivier W H', 'Initials': 'OWH', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'de Boer', 'Affiliation': 'Department of Obstetrics and Gynecology, Rijnstate, Wagnerlaan 55, 6815, AD, Arnhem, The Netherlands.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'van Bijsterveldt', 'Affiliation': 'Department of Obstetrics and Gynecology, Canisius-Wilhelmina Hospital, Weg door Jonkerbos 100, 6532, SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Ciska', 'Initials': 'C', 'LastName': 'Buijs', 'Affiliation': 'Department of Obstetrics and Gynecology, Maasziekenhuis Pantein, Dokter Kopstraat 1, 5835 BV, Beugen, The Netherlands.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pagels', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Josef Hospital Moers, Asberger Strasse 4, 47441, Moers, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tönnies', 'Affiliation': 'Department of Obstetrics and Gynecology, Bethanien Hospital Moers, Bethanienstrasse 21, 47441, Moers, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Heiden', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Antonius Hospital Kleve, Albersallee 5-7, 47533, Kleve, Germany.'}, {'ForeName': 'Nel', 'Initials': 'N', 'LastName': 'Roeleveld', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Angela H E M', 'Initials': 'AHEM', 'LastName': 'Maas', 'Affiliation': 'Department of Cardiology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}]",BMC women's health,['10.1186/s12905-020-00910-0']
446,32131866,"Efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in mechanically ventilated intensive care patients-a randomized clinical trial.","BACKGROUND


Pseudomonas aeruginosa infections are a serious threat in intensive care units (ICUs). The aim of this confirmatory, randomized, multicenter, placebo-controlled, double-blind, phase 2/3 study was to assess the efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in non-surgical ICU patients.
METHODS


Eight hundred patients aged 18 to 80 years admitted to the ICU with expected need for mechanical ventilation for ≥ 48 h were randomized 1:1 to either IC43 100 μg or saline placebo, given in two vaccinations 7 days apart. The primary efficacy endpoint was all-cause mortality in patients 28 days after the first vaccination. Immunogenicity and safety were also evaluated.
FINDINGS


All-cause mortality rates at day 28 were 29.2% vs 27.7% in the IC43 and placebo groups, respectively (P = .67). Overall survival (Kaplan-Meier survival estimates, P = .46) and proportion of patients with ≥ one confirmed P. aeruginosa invasive infection or respiratory tract infection also did not differ significantly between both groups. The geometric mean fold increase in OprF/I titers was 1.5 after the first vaccination, 20 at day 28, after the second vaccination, and 2.9 at day 180. Significantly more patients in the placebo group (96.5%) had ≥ one adverse event (AE) versus the IC43 100 μg group (93.1%) (P = .04). The most frequently reported severe AEs in the IC43 and placebo groups were respiratory failure (6.9% vs 5.7%, respectively), septic shock (4.1% vs 6.5%), cardiac arrest (4.3% vs 5.7%), multiorgan failure (4.6% vs 5.5%), and sepsis (4.6% vs 4.2%). No related serious AEs were reported in the IC43 group.
INTERPRETATION


The IC43 100 μg vaccine was well tolerated in this large population of medically ill, mechanically ventilated patients. The vaccine achieved high immunogenicity but provided no clinical benefit over placebo in terms of overall mortality.
TRIAL REGISTRATION


https://clinicaltrials.gov (NCT01563263). Registration was sent to ClinicalTrials.gov on March 14, 2012, but posted by ClinicalTrials.gov on March 26, 2012. The first subject was included in the trial on March 22, 2012.",2020,"Overall survival (Kaplan-Meier survival estimates, P = .46) and proportion of patients with ≥","['Eight hundred patients aged 18 to 80\u2009years admitted to the ICU with expected need for mechanical ventilation for ≥\u200948\u2009h', 'mechanically ventilated intensive care patients', 'non-surgical ICU patients']","['IC43 recombinant Pseudomonas aeruginosa vaccine', 'IC43 100\u2009μg or saline placebo', 'placebo']","['cardiac arrest', 'P. aeruginosa invasive infection or respiratory tract infection', 'Immunogenicity and safety', 'septic shock', 'respiratory failure', 'cause mortality', 'multiorgan failure', 'geometric mean fold increase in OprF/I titers', 'Efficacy, immunogenicity, and safety', 'sepsis', 'serious AEs', 'Overall survival (Kaplan-Meier survival estimates', 'efficacy, immunogenicity, and safety', 'mortality rates', 'overall mortality']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0085559'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",800.0,0.750041,"Overall survival (Kaplan-Meier survival estimates, P = .46) and proportion of patients with ≥","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Adlbrecht', 'Affiliation': 'Department of Cardiology, Vienna North Hospital-Clinic Floridsdorf and the Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Vienna, Austria.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Wurm', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Depuydt', 'Affiliation': 'Universitair Ziekenhuis Gent, Ghent, Belgium.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Spapen', 'Affiliation': 'Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Lorente', 'Affiliation': 'Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Staudinger', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Creteur', 'Affiliation': 'Erasme University Hospital, Brussels, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zauner', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meier-Hellmann', 'Affiliation': 'HELIOS Klinikum Erfurt GmbH, Erfurt, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Eller', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Margot Vander', 'Initials': 'MV', 'LastName': 'Laenen', 'Affiliation': 'Ziekenhuis Oost-Limburg, Campus St. Jan, Genk, Belgium.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'Szegedi Tudományegyetem, Szeged, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Várkonyi', 'Affiliation': 'Kenézy Kórház Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Schaaf', 'Affiliation': 'Klinikum Dortmund GmbH, Dortmund, Germany.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Héjja', 'Affiliation': 'Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Šrámek', 'Affiliation': 'Fakultní nemocnice U Svaté Anny v Brně, Brno, Czech Republic.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kanesa-Thasan', 'Affiliation': 'GSK Vaccines, Rockville, MD, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eder-Lingelbach', 'Affiliation': 'Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Klingler', 'Affiliation': 'Assign Data Management and Biostatistics GmbH, Innsbruck, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Dubischar', 'Affiliation': 'Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030, Vienna, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wressnigg', 'Affiliation': 'Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030, Vienna, Austria. Nina.WRESSNIGG@valneva.com.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rello', 'Affiliation': ""Centro de Investigacion Biomedica en Red (CIBERES), Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]","Critical care (London, England)",['10.1186/s13054-020-2792-z']
447,32134286,Changes in externalizing and internalizing symptoms among African American female adolescents over 1 year following a mother-daughter sexual health intervention.,"OBJECTIVE


African American female adolescents face disparities compared with White peers in the interrelated areas of mental health symptoms and sexually transmitted infection (STI) acquisition. IMARA (Informed, Motivated, Aware and Responsible about AIDS) is a group-based mother-daughter intervention addressing these factors among African American teenagers. Previous work demonstrated that female adolescents who received IMARA were 43% less likely than controls to evidence a new STI at 1 year. This report aimed to provide the 1st test of IMARA on externalizing and internalizing symptoms and an exploratory analysis of whether symptom improvements were associated with the protective effect of treatment against future STIs.
METHOD


Female African Americans aged 14-18 years ( M  = 16;  N  = 199) were randomly assigned to IMARA or a health promotion control group matched for time and structure. They completed the Youth Self-Report of externalizing and internalizing symptoms at baseline and at 6 and 12 months and were tested for STIs at baseline and 12 months; positive cases were treated. Hierarchical linear modeling tested symptom change over time, including the moderating effects of baseline symptoms.
RESULTS


Among participants who entered with high versus lower externalizing symptoms, those who received IMARA showed a slightly greater decrease in externalizing scores relative to the control ( p  = .035). For these youth, symptom improvements appeared to be associated with IMARA's protective effect against new STIs. Treatment was not associated with internalizing symptom change ( p  > .05).
CONCLUSION


IMARA shows promise in modestly reducing self-reported externalizing symptoms, although only for participants with high scores at baseline. The possibility that externalizing symptom improvement is linked with reduced STI acquisition warrants future examination. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Treatment was not associated with internalizing symptom change ( p  > .05).
","['female adolescents', 'African American female adolescents', 'Female African Americans aged 14-18 years ( M  = 16;  N  = 199', 'African American teenagers']","['IMARA', 'IMARA or a health promotion control group matched for time and structure']","['Youth Self-Report of externalizing and internalizing symptoms', 'externalizing scores', 'externalizing and internalizing symptoms', 'internalizing symptom change']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",199.0,0.0601317,"Treatment was not associated with internalizing symptom change ( p  > .05).
","[{'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Bethany C', 'Initials': 'BC', 'LastName': 'Bray', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Emerson', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'Division of Epidemiology and Biostatistics.'}, {'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Center for Dissemination and Implementation Science.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000491']
448,32185760,Ischemia-modified albumin and the IMA/albumin ratio in the diagnosis and staging of hemorrhagic shock: A randomized controlled experimental study.,"BACKGROUND


To determine the value of ischemia-modified albumin (IMA) and IMA/albumin ratio (IMAR) in the diagnosis and staging of hemorrhagic shock (HS).
METHODS


A pressure-targeted HS model was established in this study. The control and shock groups were monitored for 30 min and 60 min to simulate varying durations of exposure to HS. All subjects underwent invasive arterial monitoring during the experiment and were further divided into mild and severe shock groups based on decreases in mean arterial pressure (MAP). Biochemical and histologic comparisons were performed between the groups.
RESULTS


Our results revealed higher IMA, IMAR, lactate, total oxidant status (TOS) and oxidative stress index (OSI) levels in both the 30- and 60-min shock groups compared to the control group. Concerning MAP-based shock staging, IMA, IMAR, lactate, TOS and OSI levels in the 30-min and 60-min mild and severe shock groups were higher than those of the controls. However, there was no significant difference between the mild and severe shock groups. A significant correlation was determined between all the biomarkers evaluated and HS-induced damage in various organs. This correlation was highest in lactate and IMAR levels.
CONCLUSION


IMA and IMAR levels may be used in the early diagnosis of HS and also have the potential for use in determining the severity of HS. IMA and IMAR measurement may also be considered as an alternative or in addition to lactate measurement in the diagnosis of HS.",2020,"Our results revealed higher IMA, IMAR, lactate, total oxidant status (TOS) and oxidative stress index (OSI) levels in both the 30- and 60-min shock groups compared to the control group.",['hemorrhagic shock'],['Ischemia-modified albumin and the IMA/albumin ratio'],"['value of ischemia-modified albumin (IMA) and IMA/albumin ratio (IMAR', 'mean arterial pressure (MAP', 'Concerning MAP-based shock staging, IMA, IMAR, lactate, TOS and OSI levels', 'lactate and IMAR levels', 'IMA and IMAR measurement', 'IMA, IMAR, lactate, total oxidant status (TOS) and oxidative stress index (OSI) levels']","[{'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}]","[{'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.025634,"Our results revealed higher IMA, IMAR, lactate, total oxidant status (TOS) and oxidative stress index (OSI) levels in both the 30- and 60-min shock groups compared to the control group.","[{'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Türedi', 'Affiliation': 'Department of Emergency Medicine, Karadeniz Technical University Faculty of Medicine, Trabzon-Turkey.'}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Şahin', 'Affiliation': 'Department of Emergency Medicine, Karadeniz Technical University Faculty of Medicine, Trabzon-Turkey.'}, {'ForeName': 'Metehan', 'Initials': 'M', 'LastName': 'Akça', 'Affiliation': 'Department of Physiology, University of Health Science Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Department of Nutrition and Dietetics, Karadeniz Technical University Faculty of of Health Sciences, Trabzon-Turkey.'}, {'ForeName': 'Gökçen Derya', 'Initials': 'GD', 'LastName': 'Reis Köse', 'Affiliation': 'Department of Histology, Karadeniz Technical University Faculty of Medicine, Trabzon-Turkey.'}, {'ForeName': 'Arif Burak', 'Initials': 'AB', 'LastName': 'Çekiç', 'Affiliation': 'Department of General Surgery, Karadeniz Technical University Faculty of Medicine, Trabzon-Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Physiology, University of Health Science Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Yuluğ', 'Affiliation': 'Department of Histology, Karadeniz Technical University Faculty of Medicine, Trabzon-Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Menteşe', 'Affiliation': 'Department of Medical Laboratory Techniques, Karadeniz Technical University Faculty of of Health Sciences, Trabzon-Turkey.'}, {'ForeName': 'Süha', 'Initials': 'S', 'LastName': 'Türkmen', 'Affiliation': 'Department of Emergency Medicine, Acıbadem University Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Acar', 'Affiliation': 'Department of General Surgery, Acıbadem University Faculty of Medicine, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.32754']
449,32182098,The Effects of a Video Intervention on Posthospitalization Pulmonary Rehabilitation Uptake. A Randomized Controlled Trial.,"Rationale:  Pulmonary rehabilitation (PR) after hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD) improves exercise capacity and health-related quality of life and reduces readmissions. However, posthospitalization PR uptake is low. To date, no trials of interventions to increase uptake have been conducted. Objectives:  To study the effect of a codesigned education video as an adjunct to usual care on posthospitalization PR uptake. Methods:  The present study was an assessor- and statistician-blinded randomized controlled trial with nested, qualitative interviews of participants in the intervention group. Participants hospitalized with COPD exacerbations were assigned 1:1 to receive either usual care (COPD discharge bundle including PR information leaflet) or usual care plus the codesigned education video delivered via a handheld tablet device at discharge. Randomization used minimization to balance age, sex, FEV 1  % predicted, frailty, transport availability, and previous PR experience. Measurements and Main Results:  The primary outcome was PR uptake within 28 days of hospital discharge. A total of 200 patients were recruited, and 196 were randomized (51% female, median FEV 1%  predicted, 36 [interquartile range, 27-48]). PR uptake was 41% and 34% in the usual care and intervention groups, respectively ( P  = 0.37), with no differences in secondary (PR referral and completion) or safety (readmissions and death) endpoints. A total of 6 of the 15 participants interviewed could not recall receiving the video. Conclusions:  A codesigned education video delivered at hospital discharge did not improve posthospitalization PR uptake, referral, or completion.",2020,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","['participants in the intervention group', 'Six of the fifteen participants interviewed could not recall receiving the video', 'Pulmonary rehabilitation following hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD', '200 patients were recruited with 196 randomized (51% female, median (interquartile range', 'Post-Hospitalization Pulmonary Rehabilitation Uptake', 'Participants hospitalized with COPD exacerbations']","['usual care (COPD discharge bundle including pulmonary rehabilitation information leaflet) or usual care plus the co-designed education video delivered via a handheld tablet device at discharge', 'co-designed education video', 'Video Intervention']","['Pulmonary rehabilitation uptake', 'pulmonary rehabilitation uptake within 28 days of hospital discharge', 'secondary (pulmonary rehabilitation referral and completion) or safety (readmissions and death) endpoints']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.195828,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Barker', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Jones', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'Medical Statistics, Research & Development, Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fleming', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Samantha S C', 'Initials': 'SSC', 'LastName': 'Kon', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Clarke', 'Affiliation': 'Hillingdon Integrated Respiratory Service, the Hillingdon Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Nolan', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Suhani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maddocks', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy, and Rehabilitation, King's College London, London, United Kingdom; and.""}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Northwest London, Imperial College, London, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute and.'}, {'ForeName': 'William D-C', 'Initials': 'WD', 'LastName': 'Man', 'Affiliation': 'Harefield Respiratory Research Group and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1878OC']
450,32182123,The effect of acute dual SGLT1/SGLT2 inhibition on incretin release and glucose metabolism after gastric bypass surgery.,"Enhanced meal-related enteroendocrine secretion, particularly of glucagon-like peptide-1 (GLP-1), contributes to weight-loss and improved glycemia after Roux-en-Y gastric bypass (RYGB). Dietary glucose drives GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) secretion postoperatively. Understanding how glucose triggers incretin secretion following RYGB could lead to new treatments of diabetes and obesity. In vitro, incretin release depends on glucose absorption via sodium-glucose cotransporter 1 (SGLT1). We investigated the importance of SGLT1/SGLT2 for enteropancreatic hormone concentrations and glucose metabolism after RYGB in a randomized, controlled, crossover study. Ten RYGB-operated patients ingested 50 g of oral glucose with and without acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin. Paracetamol and 3- O -methyl-d-glucopyranose (3-OMG) were added to the glucose drink to evaluate rates of intestinal entry and absorption of glucose, respectively. Blood samples were collected for 4 h. The primary outcome was 4-h plasma GLP-1 (incremental area-under the curve, iAUC). Secondary outcomes included glucose, GIP, insulin, and glucagon. Canagliflozin delayed glucose absorption (time-to-peak 3-OMG: 50 vs. 132 min,  P  < 0.01) but did not reduce iAUC GLP-1 (6,067 vs. 7,273·min·pmol -1 ·L -1 ,  P  = 0.23), although peak GLP-1 concentrations were lowered (-28%,  P  = 0.03). Canagliflozin reduced GIP (iAUC -28%,  P  = 0.01; peak concentrations -57%,  P  < 0.01), insulin, and glucose excursions, whereas plasma glucagon (AUC 3,216 vs. 4,160 min·pmol·L -1 ,  P  = 0.02) and amino acids were increased. In conclusion, acute SGLT1/SGLT2-inhibition during glucose ingestion did not reduce 4-h plasma GLP-1 responses in RYGB-patients but attenuated the early rise in GLP-1, GIP, and insulin, whereas late glucagon concentrations were increased. The results suggest that SGLT1-mediated glucose absorption contributes to incretin hormone secretion after RYGB.",2020,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.",['gastric bypass surgery'],"['acute dual SGLT1/SGLT2 inhibition', 'oral glucose ± acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin', 'Paracetamol and 3-O-methyl-D-glucopyranose (3-OMG', 'SGLT1/SGLT2']","['4-h plasma GLP-1 (incremental area-under-the-curve, iAUC', '4-h plasma GLP-1 responses', 'peak GLP-1 concentrations', 'Blood samples', 'incretin release and glucose metabolism', 'glucose absorption via sodium-glucose cotransporter-1 (SGLT1', 'Canagliflozin delayed glucose absorption', 'iAUC GLP-1', 'insulin and glucose excursions', 'plasma glucagon', 'late glucagon concentrations', 'Canagliflozin reduced GIP', 'weight-loss and improved glycemia', 'glucose, GIP, insulin and glucagon', 'amino acids']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0248805', 'cui_str': 'Sodium-Glucose Transporter 1'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]",10.0,0.0401356,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Martinussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Viggo B', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Clinical Biochemistry, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00023.2020']
451,31775800,Eating behaviors and weight loss outcomes in a 12-month randomized trial of diet and/or exercise intervention in postmenopausal women.,"BACKGROUND


Certain eating behaviors are common among women with obesity. Whether these behaviors influence outcomes in weight loss programs, and whether such programs affect eating behaviors, is unclear.
METHODS


Our aim was to examine the effect of baseline eating behaviors on intervention adherence and weight among postmenopausal women with overweight or obesity, and to assess intervention effects on eating behaviors. Four hundred and 39 women (BMI ≥25 kg/m 2 ) were randomized to 12 months of: i) dietary weight loss with a 10% weight loss goal ('diet'; n = 118); ii) moderate-to-vigorous intensity aerobic exercise for 225 mins/week ('exercise'; n = 117); iii) combined dietary weight loss and exercise ('diet + exercise'; n = 117); or iv) no-lifestyle change control (n = 87). At baseline and 12 months, restrained eating, uncontrolled eating, emotional eating and binge eating were measured by questionnaire; weight and body composition were assessed. The mean change in eating behavior scores and weight between baseline and 12 months in the diet, exercise, and diet + exercise arms were each compared to controls using the generalized estimating equation (GEE) modification of linear regression adjusted for age, baseline BMI, and race/ethnicity.
RESULTS


Baseline restrained eating was positively associated with change in total calories and calories from fat during the dietary intervention but not with other measures of adherence. Higher baseline restrained eating was associated with greater 12-month reductions in weight, waist circumference, body fat and lean mass. Women randomized to dietary intervention had significant reductions in binge eating (- 23.7%, p = 0.005 vs. control), uncontrolled eating (- 24.3%, p < 0.001 vs. control), and emotional eating (- 31.7%, p < 0.001 vs. control) scores, and a significant increase in restrained eating (+ 60.6%, p < 0.001 vs. control); women randomized to diet + exercise reported less uncontrolled eating (- 26.0%, p < 0.001 vs. control) and emotional eating (- 22.0%, p = 0.004 vs. control), and increased restrained eating (+ 41.4%, p < 0.001 vs. control). Women randomized to exercise alone had no significant change in eating behavior scores compared to controls.
CONCLUSIONS


A dietary weight loss intervention helped women modify eating behaviors. Future research should investigate optimal behavioral weight loss interventions for women with both disordered eating and obesity.
TRIAL REGISTRATION


NCT00470119 (https://clinicaltrials.gov). Retrospectively registered May 7, 2007.",2019,"Higher baseline restrained eating was associated with greater 12-month reductions in weight, waist circumference, body fat and lean mass.","['postmenopausal women', 'women with both disordered eating and obesity', 'women with obesity', 'postmenopausal women with overweight or obesity', 'Four hundred and 39 women (BMI ≥25\u2009kg/m 2 ']","['dietary intervention', ""dietary weight loss with a 10% weight loss goal ('diet'; n\u2009=\u2009118); ii) moderate-to-vigorous intensity aerobic exercise for 225 mins/week ('exercise'; n\u2009=\u2009117); iii) combined dietary weight loss and exercise ('diet + exercise'; n\u2009=\u2009117); or iv) no-lifestyle change control"", 'baseline eating behaviors', 'dietary weight loss intervention', 'diet and/or exercise intervention', 'exercise alone']","['eating behavior scores', 'weight, waist circumference, body fat and lean mass', 'mean change in eating behavior scores and weight', 'restrained eating, uncontrolled eating, emotional eating and binge eating', 'emotional eating', 'restrained eating', 'total calories and calories', 'binge eating', 'Eating behaviors and weight loss outcomes', 'uncontrolled eating']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0723158,"Higher baseline restrained eating was associated with greater 12-month reductions in weight, waist circumference, body fat and lean mass.","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Mason', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M4-B874, PO Box 19024, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de Dieu Tapsoba', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M4-B874, PO Box 19024, Seattle, WA, 98109, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M4-B874, PO Box 19024, Seattle, WA, 98109, USA.'}, {'ForeName': 'Ching-Yun', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M4-B874, PO Box 19024, Seattle, WA, 98109, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Alfano', 'Affiliation': 'American Cancer Society, Inc., Washington, DC, 20004, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McTiernan', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M4-B874, PO Box 19024, Seattle, WA, 98109, USA. amctiern@fredhutch.org.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-019-0887-1']
452,32185660,Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial.,"PURPOSE


Middle-aged men are at high risk of suicide. While about half of those who kill themselves visit a primary care clinician (PCC) shortly before death, in current practice, few spontaneously disclose their thoughts of suicide during the visits, and PCCs seldom inquire about such thoughts. In a randomized controlled trial, we examined the effect of a tailored interactive computer program designed to encourage middle-aged men's discussion of suicide with PCCs.
METHODS


We recruited men 35-74 years old reporting recent (within 4 weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system. In the office before a visit, men viewed the intervention corresponding to their PCC's random group assignment: Men and Providers Preventing Suicide (MAPS) (20 PCCs), providing tailored multimedia promoting discussion of suicide thoughts, or control (22 PCCs), composed of a sleep hygiene video plus brief non-tailored text encouraging discussion of suicide thoughts. Logistic regressions, adjusting for patient nesting within physicians, examined MAPS' effect on patient-reported suicide discussion in the subsequent office visit.
RESULTS


Sixteen of the randomized PCCs had no patients enroll in the trial. From the panels of the remaining 26 PCCs (12 MAPS, 14 control), 48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9 years (SD 11.4). Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]). Logistic regression showed men viewing MAPS were more likely than controls to discuss suicide with their PCC (OR 5.91, 95% CI 1.59-21.94; P = 0.008; nesting-adjusted predicted effect 71% vs. 30%).
CONCLUSIONS


In addressing barriers to discussing suicide, the tailored MAPS program activated middle-aged men with active suicide thoughts to engage with PCCs around this customarily taboo topic.",2020,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"['Middle-Aged Men', 'Men and Providers Preventing Suicide (MAPS) (20 PCCs', ""middle-aged men's discussion of suicide with PCCs"", '48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9\xa0years (SD 11.4', 'Middle-aged men', 'Sixteen of the randomized PCCs', 'We recruited men 35-74\xa0years old reporting recent (within 4\xa0weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system']",['tailored interactive computer program'],['Suicide discussion'],"[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]",,0.0509858,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jerant', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. afjerant@ucdavis.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, 683 Hoes Lane West, Piscataway, NJ, 08854, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, UCD School of Medicine, 4150 V Street, Suite 2400, PSSB, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Cipri', 'Affiliation': 'Center for Healthcare Policy and Research, UCD, 2103 Stockton Blvd, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Franks', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05769-3']
453,31888569,"The FANMI (""my FAMILY"" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial.","BACKGROUND


Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed.
METHODS


The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
DISCUSSION


The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally.
TRIAL REGISTRATION


Identifier: NCT03286504, Registered September 18, 2017.",2019,"Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
","['adolescent girls and young women living with HIV', 'young people living with HIV', 'adolescent and young women living with HIV in Haiti', '160 participants ages 16-23\u2009years old', 'places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location', 'Adolescent girls and young women living with HIV in resource-limited settings']","['FANMI intervention', 'routine HIV care and individual counseling']","['viral suppression at 12\u2009months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs', 'retention in HIV care defined as being alive and in care']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}]",160.0,0.0897202,"Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA. grs2013@med.cornell.edu.'}, {'ForeName': 'Joseph Marie Bajo', 'Initials': 'JMB', 'LastName': 'Joseph', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Confident', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jean', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Louis', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bell', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Rose Cardelle', 'Initials': 'RC', 'LastName': 'Riche', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Apollon', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Reif', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rivera', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Bang', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Schackman', 'Affiliation': 'Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}]",BMC public health,['10.1186/s12889-019-8065-6']
454,31474328,Characteristics and Outcomes of Atrial Fibrillation in Patients With Thyroid Disease (from the ARISTOTLE Trial).,"Whether patients with atrial fibrillation (AF) and thyroid disease are clinically distinct from those with AF and no thyroid disease is unknown. Furthermore, the effectiveness of anticoagulation for prevention of AF-related thromboembolic events in patients with thyroid disease has not been adequately studied. Patients enrolled in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation, which compared apixaban with warfarin in patients with AF (n = 18,201), were categorized by thyroid disease history at randomization (hypothyroidism, hyperthyroidism, and no thyroid disease). Adjusted hazard ratios derived from Cox models were used to compare outcomes by thyroid disease history. Associations between randomized treatment and outcomes by thyroid disease history were examined using Cox models with interaction terms. A total of 18,021/18,201 (99%) patients had available thyroid disease history at randomization: 1,656 (9%) had hypothyroidism, 321 (2%) had hyperthyroidism, and 16,044 (89%) had no thyroid disease. When compared with those without a history of thyroid disease, patients with hypo- or hyperthyroidism were more likely to be female (60.4% vs 32.1%; 52.0% vs 32.1%; both p <0.0001). Patients with hypothyroidism were older (73 vs 70 years, p <0.0001) and more likely to have had previous falls (8.7% vs 4.3%, p <0.0001). There was no difference in clinical outcomes by thyroid disease history. The benefit of apixaban compared with warfarin was similar regardless of thyroid disease history (interaction p >0.10). In conclusion, despite differences in baseline characteristics of patients with and without thyroid disease, their clinical outcomes were similar. The benefit of apixban compared with warfarin was preserved regardless of thyroid disease history.",2019,The benefit of apixaban compared with warfarin was similar regardless of thyroid disease history (interaction p >0.10).,"['Patients With Thyroid Disease (from the ARISTOTLE Trial', 'patients with AF (n\u202f=\u202f18,201), were categorized by thyroid disease history at randomization (hypothyroidism, hyperthyroidism, and no thyroid disease', 'patients with thyroid disease', 'patients with atrial fibrillation (AF) and thyroid disease', 'A total of 18,021/18,201 (99%) patients had available thyroid disease history at randomization: 1,656 (9%) had hypothyroidism, 321 (2%) had hyperthyroidism, and 16,044 (89%) had no thyroid disease']","['warfarin', 'apixban', 'apixaban with warfarin', 'apixaban']",['hypo- or hyperthyroidism'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040128', 'cui_str': 'Thyroid Diseases'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}]",,0.108202,The benefit of apixaban compared with warfarin was similar regardless of thyroid disease history (interaction p >0.10).,"[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Goldstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: sarah.goldstein@duke.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminenspital, 3rd Medical Department, Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.07.046']
455,31549356,"Effect of Obesity on Asthma Severity in Urban School Children of Kanpur, India: An Analytical Cross-Sectional Study.","The prevalence of both Obesity and Asthma is increasing worldwide. Various epidemiological data has linked obesity with the development and severity of asthma in children. The aim of this study was to assess if any relationship exists between obesity and asthma in children. The study population included school children aged 5 to 18 years. A total of 320 asthma cases and 300 controls were included in our study. Association analysis of obesity and asthma based on epidemiological basis was measured. Out of 320 cases, 61 children were found to have moderate persistent asthma. Out of 61 moderate persistent asthma cases, 50 children were selected randomly and divided into two groups. Group I included 25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics. Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF) were measured with spirometry and Peak expiratory flow meter. Statistical analysis was done by Odds ratio and p value. Out of 320 cases, 97 were obese and 223 were non-obese. Out of 300 controls, 46 were obese and 254 were non-obese. Exposure rate for cases and controls were 30.31% and 15.33% respectively. Odds ratio was 2.40. χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant. Children who are obese are more likely to develop severe asthma than those who were not obese.",2020,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","['Out of 320 cases, 61 children were found to have moderate persistent asthma', 'Out of 320 cases, 97 were obese and 223 were non-obese', 'Out of 300 controls, 46 were obese and 254 were non-obese', 'children', '25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics', 'school children aged 5 to 18\xa0years', '320 asthma cases and 300 controls were included in our study', '61 moderate persistent asthma cases, 50 children', 'Urban School Children of Kanpur, India']",[],"['spirometry and Peak expiratory flow meter', 'Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF', 'Exposure rate']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960047', 'cui_str': 'Moderate persistent asthma (disorder)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",61.0,0.0334171,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","[{'ForeName': 'S P Senthil', 'Initials': 'SPS', 'LastName': 'Kumar', 'Affiliation': 'Columbia Asia Hospital, Whitefield, Bengaluru, Karnataka, India. drsenthilsp@yahoo.co.in.'}, {'ForeName': 'Shalu', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Femiint Health Care, Whitefield, Bengaluru, Karnataka, India.'}]",Journal of community health,['10.1007/s10900-019-00749-z']
456,32163578,Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.,"BACKGROUND


Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level.
METHODS


The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062).
RESULTS


Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97).
CONCLUSIONS


In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.",2020,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","['participants to a systolic BP target <120\u2009mmHg (intensive treatment) or <140\u2009mmHg (standard treatment', 'hypertensive adults']","['intensive blood pressure (BP', 'intensive BP lowering']","['CVD outcomes', 'Serum bicarbonate and cardiovascular events', 'composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death', 'CVD risk', 'risk of the primary CVD outcome', 'serum bicarbonate level']","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",9334.0,0.215464,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Dobre', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Renal Diseases and Hypertension, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'VA Medical Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Nephrology, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Medicine, Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz149']
457,30773500,Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation.,"INTRODUCTION


Spontaneous penile tumescence after penile prosthesis implantation has been sporadically reported in the literature.
AIM


To preserve residual erectile function of patients' spontaneous penile tumescence by sparing cavernous tissue in the course of malleable penile prosthesis implantation.
METHODS


Overall, 92 patients were randomized into 2 equal arms; patients undergoing conventional malleable penile prosthesis implantation, and patients undergoing the cavernous tissue-sparing technique. 1 month after surgery, these patients underwent penile duplex examination to assess the maximal cavernous tissue thickness around the implant cylinders. Additionally, they were asked about the occurrence of any spontaneous or arousal-induced penile tumescence.
MAIN OUTCOME MEASURES


Postoperative changes were compared with the preoperative ones.
RESULTS


The mean maximal cavernous tissue thickness was shown to be significantly higher in the cavernous tissue-sparing group compared with the conventional surgery group (5.2 ± 0.8 mm vs 2.2 ± 1.04 mm, P < .01). In the cavernous tissue-sparing group, 41 of 46 patients (89.13%) reported having a significantly higher incidence of residual penile tumescence vs 7 of 46 patients (15.2%) in the conventional surgery group (P < .001). The postoperative penile girth was significantly higher in the cavernous tissue-sparing group than in the conventional surgery group (11.16 ± 1.1 cm vs 10.11 ± 1.15 cm, P < .001).
CLINICAL IMPLICATIONS


This study provides a step-by-step approach to maintaining post-implantation penile tumescence and preserving penile girth in a reproducible manner.
STRENGTHS & LIMITATIONS


This is the first study to demonstrate the benefits of implanting a penile prosthesis while the penis is in a pharmacologically induced tumescent state. It is also the first to make use of ultrasound imaging in assessing postoperative corporal tissue. The main limitations are the short postoperative follow-up period and the non-blinding of measurements.
CONCLUSION


It could be concluded that the cavernous tissue-sparing technique is a reproducible technique that has the added value of preserving residual erectile function in the form of retained postoperative penile tumescence and preserved penile girth. Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med 2019;16:474-478.",2019,"The postoperative penile girth was significantly higher in the cavernous tissue-sparing group than in the conventional surgery group (11.16 ± 1.1 cm vs 10.11 ± 1.15 cm, P < .001).
","['92 patients were randomized into 2 equal arms', ""patients' spontaneous penile tumescence"", 'patients undergoing']","['cavernous tissue-sparing technique', 'conventional malleable penile prosthesis implantation', 'penile duplex examination']","['maximal cavernous tissue thickness', 'residual penile tumescence', 'mean maximal cavernous tissue thickness', 'occurrence of any spontaneous or arousal-induced penile tumescence', 'postoperative penile girth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0087121', 'cui_str': 'Penile Tumescence'}]","[{'cui': 'C0205201', 'cui_str': 'Cavernous (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0403319', 'cui_str': 'Penile Prosthesis Implantation'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205201', 'cui_str': 'Cavernous (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0087121', 'cui_str': 'Penile Tumescence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",92.0,0.0382835,"The postoperative penile girth was significantly higher in the cavernous tissue-sparing group than in the conventional surgery group (11.16 ± 1.1 cm vs 10.11 ± 1.15 cm, P < .001).
","[{'ForeName': 'Adham', 'Initials': 'A', 'LastName': 'Zaazaa', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: adhamzaazaa@gmail.com.'}, {'ForeName': 'Taymour', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.01.012']
458,31444008,SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy.,"PURPOSE


This study examined whether short-term use of topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy affected the efficacy of selective laser trabeculoplasty (SLT).
DESIGN


Double-masked, randomized, placebo-controlled, dual-center, multisurgeon trial.
PARTICIPANTS


Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy were randomized to 1 of 3 groups in a ratio of 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears.
METHODS


After SLT, patients randomized into each group were instructed to use an unmarked drop 4 times daily starting the day of SLT and continuing for 4 additional days. The Kruskal-Wallis test and Wilcoxon rank-sum test were used for continuous variables when comparing 2 or 3 treatment groups, respectively. The Fisher exact test was used for categorical variables.
MAIN OUTCOME MEASURES


The primary outcome of this study was IOP at 12 weeks. Secondary outcome measures included IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation.
RESULTS


Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites. The NSAID, steroid, and placebo groups were similar in baseline demographics and baseline IOP (mean, 23.3±3.9 mmHg; P = 0.57). There was no statistically significant difference in IOP decrease among groups at week 6. Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1 mmHg, -5.2±2.7 mmHg, and -3±4.3 mmHg, respectively; P = 0.02 [analysis of variance] and P = 0.002 [t test] for NSAID vs. placebo groups; P = 0.02 for steroid vs. placebo groups).
CONCLUSIONS


Significantly better IOP reduction at 12 weeks was measured in eyes treated with steroid or NSAID drops after SLT. Short-term postoperative use of NSAID or steroid drops may improve IOP reduction after SLT. Longer-term follow-up studies are indicated.",2019,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","['Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy', 'Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites']","['NSAID or steroid', 'ketorolac 0.5%, prednisolone 1%, or saline tears', 'selective laser trabeculoplasty (SLT', 'placebo', 'topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy', 'Laser Trabeculoplasty']","['baseline demographics and baseline IOP', 'IOP', 'IOP reduction', 'IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation', 'IOP decrease', 'Selective Laser Trabeculoplasty Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0395482', 'cui_str': 'LTP - laser trabeculoplasty'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]",85.0,0.443463,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","[{'ForeName': 'Sylvia L', 'Initials': 'SL', 'LastName': 'Groth', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Eiyass', 'Initials': 'E', 'LastName': 'Albeiruti', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Nunez', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Fajardo', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Sharpsten', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Schuman', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Goldberg', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California. Electronic address: eye-chair@stanford.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.05.032']
459,31471088,Assessment of Vitreous Structure and Visual Function after Neodymium:Yttrium-Aluminum-Garnet Laser Vitreolysis.,"PURPOSE


Neodymium:yttrium-aluminum-garnet (Nd:YAG) laser treatment is performed on vitreous floaters, but studies of structural and functional effects with objective outcome measures are lacking. This study evaluated Nd:YAG laser effects by comparing participants with vitreous floaters who previously underwent laser treatment with untreated control participants and healthy persons without vitreous floaters using quantitative ultrasonography to evaluate vitreous structure and by measuring visual acuity and contrast sensitivity function to assess vision.
DESIGN


Retrospective, comparative study.
PARTICIPANTS


One eye was enrolled for each of 132 participants: 35 control participants without vitreous floaters, 59 participants with untreated vitreous floaters, and 38 participants with vitreous floaters previously Nd:YAG-treated. Of these, 25 were dissatisfied and sought vitrectomy; 13 were satisfied with observation.
METHODS


The 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-39) to assess participant visual well-being, quantitative ultrasonography (QUS) to measure vitreous echodensity, and best-corrected visual acuity (BCVA) and contrast sensitivity function (CSF) to evaluate vision.
MAIN OUTCOME MEASURES


Results of NEI-VFQ-39, QUS, BCVA, and CSF.
RESULTS


Compared with control participants without vitreous floaters, participants with untreated vitreous floaters showed worse NEI-VFQ-39 results, 57% greater vitreous echodensity, and significant (130%) CSF degradation (P < 0.001 for each). Compared with untreated eyes with vitreous floaters, Nd:YAG-treated eyes had 23% less vitreous echodensity (P < 0.001), but no differences in NEI-VFQ-39 (P = 0.51), BCVA (P = 0.42), and CSF (P = 0.17) results. Of 38 participants with vitreous floaters who previously were treated with Nd:YAG, 25 were dissatisfied and seeking vitrectomy, whereas 13 were satisfied with observation. Participants seeking vitrectomy showed 24% greater vitreous echodensity (P = 0.018) and 52% worse CSF (P = 0.006). Multivariate linear regression models confirmed these findings.
CONCLUSIONS


As a group, participants previously treated with Nd:YAG laser for bothersome vitreous floaters showed less dense vitreous, but similar visual function as untreated control participants with vitreous floaters. Because some treated eyes showed less dense vitreous and better visual function than those of untreated control participants, a prospective randomized study of Nd:YAG laser treatment of vitreous is warranted, using uniform laser treatment parameters and objective quantitative outcome measures.",2019,Participants seeking vitrectomy showed 24% greater vitreous echodensity (P = 0.018) and 52% worse CSF (P = 0.006).,"['participants with vitreous floaters who previously underwent laser treatment with untreated control participants and healthy persons without vitreous floaters using', '38 participants with vitreous floaters who previously were treated with Nd:YAG, 25 were dissatisfied and seeking vitrectomy, whereas 13 were satisfied with observation', 'One eye was enrolled for each of 132 participants: 35 control participants without vitreous floaters, 59 participants with untreated vitreous floaters, and 38 participants with vitreous floaters previously Nd:YAG-treated']","['BCVA', 'Nd:YAG laser', 'quantitative ultrasonography', 'Neodymium:Yttrium-Aluminum-Garnet Laser Vitreolysis', 'Nd:YAG', 'Neodymium:yttrium-aluminum-garnet']","['39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-39) to assess participant visual well-being, quantitative ultrasonography (QUS) to measure vitreous echodensity, and best-corrected visual acuity (BCVA) and contrast sensitivity function (CSF) to evaluate vision', 'visual function', 'vitreous echodensity', 'CSF degradation', 'NEI-VFQ-39, QUS, BCVA, and CSF', 'NEI-VFQ-39 results', 'NEI-VFQ-39']","[{'cui': 'C0016242', 'cui_str': 'Vitreous floaters (disorder)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}]","[{'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",132.0,0.0335187,Participants seeking vitrectomy showed 24% greater vitreous echodensity (P = 0.018) and 52% worse CSF (P = 0.006).,"[{'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Nguyen', 'Affiliation': 'VMR Institute for Vitreous Macula Retina, Huntington Beach, California.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Nguyen-Cuu', 'Affiliation': 'VMR Institute for Vitreous Macula Retina, Huntington Beach, California.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Yee', 'Affiliation': 'VMR Institute for Vitreous Macula Retina, Huntington Beach, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mamou', 'Affiliation': 'Lizzi Center for Biomedical Engineering, Riverside Research, New York, New York.'}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Silverman', 'Affiliation': 'Department of Ophthalmology, College of Physicians & Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Ketterling', 'Affiliation': 'Lizzi Center for Biomedical Engineering, Riverside Research, New York, New York.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sebag', 'Affiliation': 'VMR Institute for Vitreous Macula Retina, Huntington Beach, California; Department of Ophthalmology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; Doheny Eye Institute & Department of Ophthalmology, University of California, Los Angeles, Pasadena, California. Electronic address: jsebag@VMRinstitute.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.06.021']
460,31530611,"Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial.","INTRODUCTION


Neoadjuvant chemotherapy for breast cancer treatment is prescribed to facilitate surgery and provide confirmation of drug-sensitive disease, and the achievement of pathological complete response (pCR) predicts improved long-term outcomes. Docosahexaenoic acid (DHA) has been shown to reduce tumour growth in preclinical models when combined with chemotherapy and is known to beneficially modulate systemic immune function. The purpose of this trial is to investigate the benefit of DHA supplementation in combination with neoadjuvant chemotherapy in patients with breast cancer.
METHODS AND ANALYSIS


This is a double-blind, phase II, randomised controlled trial of 52 women prescribed neoadjuvant chemotherapy to test if DHA supplementation enhances chemotherapy efficacy. The DHA supplementation group will take 4.4 g/day DHA orally, and the placebo group will take an equal fat supplement of vegetable oil. The primary outcome will be change in Ki67 labelling index from prechemotherapy core needle biopsy to definitive surgical specimen. The secondary endpoints include assessment of (1) DHA plasma phospholipid content; (2) systemic immune cell types, plasma cytokines and inflammatory markers; (3) tumour markers for apoptosis and tumour infiltrating lymphocytes; (4) rate of pCR in breast and in axillary nodes; (5) frequency of grade 3 and 4 chemotherapy-associated toxicities; and (6) patient-perceived quality of life. The trial has 81% power to detect a significant between-group difference in Ki67 index with a two-sided t-test of less than 0.0497, and accounts for 10% dropout rate.
ETHICS AND DISSEMINATION


This study has full approval from the Health Research Ethics Board of Alberta - Cancer Committee (Protocol #: HREBA.CC-18-0381). We expect to present the findings of this study to the scientific community in peer-reviewed journals and at conferences. The results of this study will provide evidence for supplementing with DHA during neoadjuvant chemotherapy treatment for breast cancer.
TRIAL REGISTRATION NUMBER


NCT03831178.",2019,Docosahexaenoic acid (DHA) has been shown to reduce tumour growth in preclinical models when combined with chemotherapy and is known to beneficially modulate systemic immune function.,"['52 women prescribed', 'patients with breast cancer', 'breast cancer (DHA WIN']","['Docosahexaenoic acid (DHA', 'neoadjuvant chemotherapy', 'placebo', 'docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone', 'DHA supplementation']","['Ki67 index', 'assessment of (1) DHA plasma phospholipid content; (2) systemic immune cell types, plasma cytokines and inflammatory markers; (3) tumour markers for apoptosis and tumour infiltrating lymphocytes; (4) rate of pCR in breast and in axillary nodes; (5) frequency of grade 3 and 4 chemotherapy-associated toxicities; and (6) patient-perceived quality of life', 'chemotherapy efficacy', 'change in Ki67 labelling index from prechemotherapy core needle biopsy to definitive surgical specimen']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1869090', 'cui_str': 'Tumour markers (SMQ)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1318309', 'cui_str': 'Biopsy, Large-Core Needle'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1647891', 'cui_str': 'Specimen obtained by surgical procedure (specimen)'}]",52.0,0.470162,Docosahexaenoic acid (DHA) has been shown to reduce tumour growth in preclinical models when combined with chemotherapy and is known to beneficially modulate systemic immune function.,"[{'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Newell', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mackey', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Bigras', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mirey', 'Initials': 'M', 'LastName': 'Alvarez-Camacho', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Goruk', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Miede', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Chisotti', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Postovit', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mazurak', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Berendt', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Wei-Feng', 'Initials': 'WF', 'LastName': 'Dong', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sanraj K', 'Initials': 'SK', 'LastName': 'Basi', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Anil Abraham', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'King', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Meza-Junco', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Xiaofu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Field', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada catherine.field@ualberta.ca.'}]",BMJ open,['10.1136/bmjopen-2019-030502']
461,31530615,Selective versus stepwise removal of deep carious lesions in permanent teeth: a randomised controlled trial from Egypt-an interim analysis.,"OBJECTIVES


To compare the success, survival and costs of selective versus stepwise carious tissue removal (SE/SW) in permanent teeth with deep (>2/3 dentine depth) carious lesions.
DESIGN


Randomised controlled, unicentre, clustered two-arm superiority trial.
SETTING


Outpatient clinic of a private university in Cairo, Egypt.
PARTICIPANTS


One hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled. Premolars/molars with occlusal/occlusal-proximal deep lesions (radiographically >2/3 dentine), sensible pulps, without spontaneous pain, were included.
INTERVENTIONS


Peripheral carious tissue removal to hard dentine was performed. Pulpo-proximally, soft dentine was left. A glass ionomer (GI) restoration was placed. After 3-4 months, teeth were randomly allocated to SE (n=66), with reduction of the GI into a base and no further tissue removal, followed by a composite resin restoration, or SW (n=66), with full removal of the GI, additional excavation until firm dentine pulpo-proximally, followed by a GI-based composite restoration. Mean follow-up was 1 year.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome was success (absence of endodontic/restorative complications). Secondary outcomes were tooth survival and initial and total treatment costs.
RESULTS


Zero/five pulp exposures occurred during SE/SW, and seven/five SE/SW teeth required endodontic therapy. Success after 12 months was 89.4% for SE and 84.9% for SW. The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox). Initial treatment costs were significantly higher for SW (mean (SD): 507.5 (123.4) Egyptian pounds (EGP)) than SE (mean (SD): 456.6 (98.3) EGP), while total costs showed no significant difference (p>0.05).
CONCLUSION


Within the limitations of this interim analysis, and considering the depth of these lesions (>2/3 dentine), SE and SW showed similar risk of failure and overall costs after 1 year.
TRIAL REGISTRATION NUMBER


PACTR201603001396248.",2019,"The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox).","['permanent teeth', 'Premolars/molars with occlusal/occlusal-proximal deep lesions (radiographically >2/3 dentine), sensible pulps, without spontaneous pain, were included', 'permanent teeth with deep (>2/3 dentine depth) carious lesions', 'Outpatient clinic of a private university in Cairo, Egypt', 'One hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled']","['selective versus stepwise carious tissue removal (SE/SW', 'SE']","['success (absence of endodontic/restorative complications', 'risk of failure and overall costs', 'Initial treatment costs', 'mean time free of complications', 'success, survival and costs', 'tooth survival and initial and total treatment costs']","[{'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",115.0,0.244212,"The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox).","[{'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Labib', 'Affiliation': 'Operative Dentistry, Misr International University (MIU), Cairo, Egypt.'}, {'ForeName': 'Olfat E', 'Initials': 'OE', 'LastName': 'Hassanein', 'Affiliation': 'Conservative Dentistry, Cairo University, Giza, Egypt.'}, {'ForeName': 'Makeen', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'Operative Dentistry, Misr International University (MIU), Cairo, Egypt.'}, {'ForeName': 'Asmaa', 'Initials': 'A', 'LastName': 'Yassen', 'Affiliation': 'Conservative Dentistry, Cairo University, Giza, Egypt.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Operative and Preventive Dentistry, Charite Universitatsmedizin Berlin Campus Benjamin Franklin, Berlin, Germany falk.schwendicke@charite.de.'}]",BMJ open,['10.1136/bmjopen-2019-030957']
462,31358387,"No CFH or ARMS2 Interaction with Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin on Progression of Age-Related Macular Degeneration in the Age-Related Eye Disease Study 2: Age-Related Eye Disease Study 2 Report No. 18.","PURPOSE


To assess whether genotypes at 2 major loci associated with age-related macular degeneration (AMD), complement factor H (CFH), or age-related maculopathy susceptibility 2 (ARMS2), modify the response to oral nutrients for the treatment of AMD in the Age-Related Eye Disease Study 2 (AREDS2).
DESIGN


Post hoc analysis of a randomized trial.
PARTICIPANTS


White AREDS2 participants.
METHODS


AREDS2 participants (n = 4203) with bilateral large drusen or late AMD in 1 eye were assigned randomly to lutein and zeaxanthin, omega-3 fatty acids, both, or placebo, and most also received the AREDS supplements. A secondary randomization assessed modified AREDS supplements in 4 treatment arms: lower zinc dosage, omission of β-carotene, both, or no modification. To evaluate the progression to late AMD, fundus photographs were obtained at baseline and annual study visits, and history of treatment for late AMD was obtained at study visits and 6-month interim telephone calls. Participants were genotyped for the single-nucleotide polymorphisms rs1061170 in CFH and rs10490924 in ARMS2. Bivariate frailty models using both eyes were conducted, including a gene-supplement interaction term and adjusting for age, gender, level of education, and smoking status. The main treatment effects, as well as the direct comparison between lutein plus zeaxanthin and β-carotene, were assessed for genotype interaction.
MAIN OUTCOME MEASURES


The interaction between genotype and the response to AREDS2 supplements regarding progression to late AMD, any geographic atrophy (GA), and neovascular AMD.
RESULTS


Complete data were available for 2775 eyes without baseline late AMD (1684 participants). The participants (mean age ± standard deviation, 72.1±7.7 years; 58.5% female) were followed up for a median of 5 years. The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5  and P = 0.002, respectively), but not any GA (P = 0.097). The CFH risk allele was not associated with AMD progression. Genotype did not modify significantly the response to any of the AREDS2 supplements.
CONCLUSIONS


CFH and ARMS2 risk alleles do not modify the response to the AREDS2 nutrient supplements with respect to the progression to late AMD (GA and neovascular AMD).",2019,"The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5  and P = 0.002, respectively), but not any GA (P = 0.097).","['participants (mean age ± standard deviation, 72.1±7.7 years; 58.5% female', '2775 eyes without baseline late AMD (1684 participants', 'participants (n\xa0= 4203) with bilateral large drusen or late AMD in 1 eye', 'Age-Related Macular Degeneration in the Age-Related Eye Disease\xa0Study 2: Age-Related Eye Disease Study 2', 'White AREDS2 participants']","['AREDS2', 'Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin', 'lutein and zeaxanthin, omega-3 fatty acids, both, or placebo']","['progression to late AMD and neovascular AMD', 'lower zinc dosage, omission of β-carotene, both, or no modification']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1260959', 'cui_str': 'Drusen'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]",1684.0,0.0431204,"The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5  and P = 0.002, respectively), but not any GA (P = 0.097).","[{'ForeName': 'Freekje', 'Initials': 'F', 'LastName': 'van Asten', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Preventive Medicine and Genetics, Genomics & Informatics, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Biostatistics, The EMMES Company, Rockville, Maryland.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Ratnapriya', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaroop', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Ruzong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: echew@nei.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.06.004']
463,32160779,Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients.,"BACKGROUND


There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES).
METHODS


This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively.
RESULTS


Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference -1.4% [upper limit of 1-sided 95% CI: -3.2%];  P   for noninferiority  <0.001; BES versus ZES: absolute risk difference -1.7% [upper limit of 1-sided 95% CI: -3.6%];  P   for noninferiority  <0.001).
CONCLUSIONS


The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01397175.",2020,The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up.,"['1911 patients randomized to either', 'in a 1:1:1 ratio in 15 centers across South Korea', 'All-Comer Patients']","['Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES', 'Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents', 'EES', 'ZES', 'BES, EES, or ZES']","['device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization', 'rate of device-oriented composite outcome', 'slow recruitment and low event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1911.0,0.163522,The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up.,"[{'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Youn', 'Affiliation': 'Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).'}, {'ForeName': 'Sung Gyun', 'Initials': 'SG', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).'}, {'ForeName': 'Junghan', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).'}, {'ForeName': 'Keum Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Inha University Hospital, Inha University College of Medicine, Incheon, South Korea (K.S.P.).'}, {'ForeName': 'Jin Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Daegu Catholic University Medical Center, Catholic University, South Korea (J.-B.L.).'}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Yoo', 'Affiliation': 'Division of Cardiology, Gangneung Asan Hospital, University of Ulsan College of Medicine, South Korea (S.-Y.Y.).'}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, Korea University Anam Hospital (D.-S.L.), Korea University, Seoul, South Korea.'}, {'ForeName': 'Jang Hyun', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, St. Carollo General Hospital, Suncheon, South Korea (J.H.C.).'}, {'ForeName': 'Cheol Ung', 'Initials': 'CU', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Korea University Guro Hospital (C.U.C.), Korea University, Seoul, South Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'The Heart Center, Chonnam National University Hospital, Chonnam National University, Gwangju, South Korea (M.H.J.).'}, {'ForeName': 'Kyoo-Rok', 'Initials': 'KR', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Kangdong Sacred Heart Hospital Hallym University, Seoul (K.-R.H.).'}, {'ForeName': 'Kwang Soo', 'Initials': 'KS', 'LastName': 'Cha', 'Affiliation': 'Division of Cardiology, Pusan National University Hospital, Pusan National University, Busan, South Korea (K.S.C.).'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Inje University Ilsan-Paik Hospital, Inje University, Goyang, South Korea (S.Y.L.).'}, {'ForeName': 'Hyun-Hee', 'Initials': 'HH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University, South Korea (H.-H.C.).'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Eulji University, Seoul, South Korea (J.W.C.).'}, {'ForeName': 'Min Su', 'Initials': 'MS', 'LastName': 'Hyon', 'Affiliation': 'Division of Cardiology, Soonchunhyang University Seoul Hospital, Soonchunhyang University, South Korea (M.S.H.).'}, {'ForeName': 'Moo-Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Dong-A University Hospital, Dong-A University, Busan, South Korea (M.-H.K.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008525']
464,30566602,AS03-Adjuvanted H5N1 Avian Influenza Vaccine Modulates Early Innate Immune Signatures in Human Peripheral Blood Mononuclear Cells.,"BACKGROUND


Adjuvant System 03 (AS03) markedly enhances responses to influenza A/H5N1 vaccines, but the mechanisms of this enhancement are incompletely understood.
METHODS


Using ribonucleic acid sequencing on peripheral blood mononuclear cells (PBMCs) from AS03-adjuvanted and unadjuvanted inactivated H5N1 vaccine recipients, we identified differentially expressed genes, enriched pathways, and genes that correlated with serologic responses. We compared bulk PBMC findings with our previously published assessments of flow-sorted immune cell types.
RESULTS


AS03-adjuvanted vaccine induced the strongest differential signals on day 1 postvaccination, activating multiple innate immune pathways including interferon and JAK-STAT signaling, Fcγ receptor (FcγR)-mediated phagocytosis, and antigen processing and presentation. Changes in signal transduction and immunoglobulin genes predicted peak hemagglutinin inhibition (HAI) titers. Compared with individual immune cell types, activated PBMC genes and pathways were most similar to innate immune cells. However, several pathways were unique to PBMCs, and several pathways identified in individual cell types were absent in PBMCs.
CONCLUSIONS


Transcriptomic analysis of PBMCs after AS03-adjuvanted H5N1 vaccination revealed early activation of innate immune signaling, including a 5- to 8-fold upregulation of FcγR1A/1B/1C genes. Several early gene responses were correlated with HAI titer, indicating links with the adaptive immune response. Although PBMCs and cell-specific results shared key innate immune signals, unique signals were identified by both approaches.",2019,"RESULTS


AS03-adjuvanted vaccine induced the strongest differential signals on day 1 postvaccination, activating multiple innate immune pathways including interferon and JAK-STAT signaling, Fcγ receptor (FcγR)-mediated phagocytosis, and antigen processing and presentation.",['Human Peripheral Blood Mononuclear Cells'],"['ribonucleic acid sequencing', 'AS03-Adjuvanted H5N1 Avian Influenza Vaccine']","['peripheral blood mononuclear cells (PBMCs', 'strongest differential signals on day 1 postvaccination, activating multiple innate immune pathways including interferon and JAK-STAT signaling, Fcγ receptor (FcγR)-mediated phagocytosis, and antigen processing and presentation', 'peak hemagglutinin inhibition (HAI) titers']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0016627', 'cui_str': 'Influenza in Birds'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0206430', 'cui_str': 'Antigen Processing'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.0234972,"RESULTS


AS03-adjuvanted vaccine induced the strongest differential signals on day 1 postvaccination, activating multiple innate immune pathways including interferon and JAK-STAT signaling, Fcγ receptor (FcγR)-mediated phagocytosis, and antigen processing and presentation.","[{'ForeName': 'Leigh M', 'Initials': 'LM', 'LastName': 'Howard', 'Affiliation': 'Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Goll', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Travis L', 'Initials': 'TL', 'LastName': 'Jensen', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Hoek', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Nripesh', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': 'HudsonAlpha Institute for Biotechnology, Huntsville, Alabama.'}, {'ForeName': 'Casey E', 'Initials': 'CE', 'LastName': 'Gelber', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Shawn E', 'Initials': 'SE', 'LastName': 'Levy', 'Affiliation': 'HudsonAlpha Institute for Biotechnology, Huntsville, Alabama.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Joyce', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Link', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}]",The Journal of infectious diseases,['10.1093/infdis/jiy721']
465,32173916,"Efficacy of guselkumab in a subpopulation with pustulotic arthro-osteitis through week 52: an exploratory analysis of a phase 3, randomized, double-blind, placebo-controlled study in Japanese patients with palmoplantar pustulosis.","BACKGROUND


Previous studies of guselkumab have demonstrated clinical benefits in patients with plaque-type psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and palmoplantar pustulosis (PPP).
OBJECTIVE


The aim of this exploratory analysis of a double-blind, multicenter, placebo-controlled, phase 3 study in Japanese patients with PPP was to evaluate the efficacy of guselkumab in the subset of patients with pustulotic arthro-osteitis (PAO).
METHODS


Patients were randomized to receive guselkumab 100 or 200 mg at weeks 0, 4, 12 and every 8 weeks, or placebo with cross-over to guselkumab 100 or 200 mg at week 16 (placebo group). Efficacy endpoints were changes from baseline in magnetic resonance imaging (MRI) score, EuroQOL-5 dimensions (EQ-5D) index score, EQ-5D pain/discomfort dimension score and C-reactive protein (CRP, mg/L) level in all PAO patients through week 52. Data from both guselkumab groups were combined and presented as results for a single overall guselkumab group.
RESULTS


Among 159 patients with PPP, 66 with PAO were randomized across treatment groups. For patients with MRI data for all regions assessed, the proportion of patients in the guselkumab group with PAO characterized as severe decreased from 23.8% (10/42) at baseline to 5.4% (2/42) at week 52. The mean (SD) change from baseline at week 52 in EQ-5D index score was 0.20 (0.17) among PPP patients with PAO and 0.15 (0.17) among those without PAO in the guselkumab group. Among all PAO patients, the proportions with an EQ-5D pain/discomfort dimension score of no or slight pain/discomfort in the guselkumab group increased from baseline to week 52 [33.3% (7/21) vs. 87.5% (35/40)]. The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline [-1.71 (8.16) mg/L].
CONCLUSION


Guselkumab treatment showed beneficial outcomes for PAO signs and symptoms in Japanese patients with PPP.",2020,"The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline (-1.71 [8.16] mg/L).
","['Japanese patients with PPP', '159 patients with PPP, 66 with PAO', 'Japanese patients with palmoplantar pustulosis', 'Patients', 'patients with plaque-type psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and palmoplantar pustulosis (PPP', 'patients with pustulotic arthro-osteitis (PAO']","['placebo', 'placebo with cross-over to guselkumab 100 mg or 200 mg at week 16 (placebo', 'guselkumab', 'Guselkumab treatment']","['PAO signs and symptoms', 'mean (SD) CRP levels', 'EQ-5D index score', 'magnetic resonance imaging (MRI) score, EuroQOL-5 dimensions (EQ-5D) index score, EQ-5D pain/discomfort dimension score, and C-reactive protein (CRP, mg/L) level', 'EQ-5D pain/discomfort dimension score of no or slight pain/discomfort']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0030246', 'cui_str': 'Pustulosis of Palms and Soles'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0343055', 'cui_str': 'Generalized pustular psoriasis (disorder)'}, {'cui': 'C0748052', 'cui_str': 'Exfoliative psoriasis'}, {'cui': 'C0029400', 'cui_str': 'Bone Inflammation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}]",159.0,0.371991,"The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline (-1.71 [8.16] mg/L).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Dermatology, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Radiology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Morishima', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Goto', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Terui', 'Affiliation': 'Department of Dermatology, Nihon University School of Medicine, Tokyo, Japan.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16355']
466,32167240,Single application of lamellar moisturizers provides significantly increased hydration of the stratum corneum for up to 24 hours in a randomized trial.,"BACKGROUND


Some moisturizing formulations can help restore and maintain the barrier function of the skin.
OBJECTIVES


This study was designed to assess the hydration potential of three lamellar moisturizers relative to a control (nonlamellar) moisturizer.
METHODS


Healthy adults aged 18 to 65 years with self-reported sensitive skin, dry or very dry skin and Corneometry values of ≤40 a.u. on the lower legs, entered this randomized, evaluator-blind study. Products A and B together with a control product (Control X) were applied to one leg, while Product C and Control Y were applied to the other leg; with an untreated control site in both cases. The primary efficacy variable was the change from baseline in Corneometer assessments at 24 hours (Products A and B) or 12 hours (Product C) postapplication.
RESULTS


At all timepoints (n = 30), Products A and B showed higher mean Corneometer readings compared to baseline and changes from baseline were statistically significant when compared to untreated sites. Higher mean readings relative to baseline were seen at sites treated with Control X (smaller magnitude than Product A and B) and with Product C. These changes were significant compared to the untreated site at 30 minutes and 2 hours (Control X), and at 30 minutes and 12 hours (Product C). Additionally, Control Y increased significantly at 12 hours.
CONCLUSION


A single application of a lamellar moisturizer significantly increased hydration of the stratum corneum for up to 24 hours (Products A and B) or 12 hours (Product C).",2020,A single application of a lamellar moisturizer significantly increased hydration of the stratum corneum for up to 24 hours (Products A and B) or 12 hours (Product C).,"['Healthy adults aged 18 to 65\xa0years with self-reported sensitive skin, dry or very dry skin and Corneometry values of ≤40 a.u']",['Product C'],"['hydration of the stratum corneum', 'mean Corneometer readings']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0151908', 'cui_str': 'Dry skin (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",[],"[{'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0296584,A single application of a lamellar moisturizer significantly increased hydration of the stratum corneum for up to 24 hours (Products A and B) or 12 hours (Product C).,"[{'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Nisbet', 'Affiliation': 'Skin Health Medical Affairs, GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dykes', 'Affiliation': 'Cutest Systems Ltd, Cardiff, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Snatchfold', 'Affiliation': 'Skin Health Medical Affairs, GSK Consumer Healthcare, Weybridge, UK.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13361']
467,31587995,"Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial.","INTRODUCTION


Alzheimer's disease (AD) is a disabling, common cause of dementia, and agitation is one of the most common and distressing symptoms for patients with AD. Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
METHODS


S-CitAD is a NIH-funded, investigator-initiated, randomized, multicenter clinical trial. Participants receive a structured psychosocial intervention (PSI) as standard of care. Participants without sufficient response to PSI are randomized to receive 15 mg escitalopram/day or a matching placebo in addition to PSI. Primary outcome is the Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC).
DISCUSSION


S-CitAD will provide information about a practical, immediately available approach to treating agitation in patients with AD. S-CitAD may become a model of how to evaluate and predict treatment response in patients with AD and agitation as a neuropsychiatric symptom (ClinicalTrials.gov Identifier: NCT03108846).",2019,"Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
","['patients with AD', ""Alzheimer's disease (S-CitAD"", 'Participants without sufficient response to PSI']","['Escitalopram', 'structured psychosocial intervention (PSI', '15\xa0mg escitalopram/day or a matching placebo']","[""Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.488123,"Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: sehrhar6@jhu.edu.'}, {'ForeName': 'Anton P', 'Initials': 'AP', 'LastName': 'Porsteinsson', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Munro', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Pollock', 'Affiliation': 'Campbell Family Research Institute and Division of Adult Neurodevelopment and Geriatric Psychiatry, CAMH, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Davangere P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Division of Geriatric Psychiatry, New York State Psychiatric Institute and College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Roper St. Francis Research and Innovation Center, Charleston, SC, USA; Medical University of South Carolina, College of Health Professionals and Ralph H Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Campbell Family Research Institute and Division of Adult Neurodevelopment and Geriatric Psychiatry, CAMH, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychiatry, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Clinical Neurosciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Departments of Psychiatry and the Behavioral Sciences and Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA; Department of Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA.'}, {'ForeName': 'Sheriza N', 'Initials': 'SN', 'LastName': 'Baksh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lea T', 'Initials': 'LT', 'LastName': 'Drye', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Avramopoulos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Constantine G', 'Initials': 'CG', 'LastName': 'Lyketsos', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.06.4946']
468,31873950,2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial.,"BACKGROUND


Selective neck dissection (SND) is a mainstay of head and neck cancer treatment. A common sequela is shoulder syndrome from spinal accessory nerve (SAN) trauma. Extensive dissection in neck levels 2 and 5 leads to SAN dysfunction. However, it is not known whether limited level 2 dissection reduces SAN injury. The purpose of this double-blind randomized controlled trial was to determine whether omitting level 2b dissection would improve shoulder-related quality of life and function.
METHODS


Patients with head and neck cancers undergoing surgery were randomized 1:1 to SND without level 2b dissection (group 1) or with it (group 2) on their dominant-hand side. Patients, caregivers, and assessors were blinded. The primary outcome was the change in the Neck Dissection Impairment Index (NDII) score after 6 months. An a priori calculation of the minimally important clinical difference in the NDII score was determined to establish a sample size of 15 patients per group (power = 0.8). Secondary outcomes included shoulder strength and range of motion (ROM) and SAN nerve conduction. The trial was registered at ClinicalTrials.gov (NCT00765791).
RESULTS


Forty patients were enrolled, and 30 were included (15 per group). Six months after the surgery, group 2 demonstrated a significant median decrease in the NDII from the baseline (30 points) and in comparison with group 1, whose NDII dropped 17.5 points (P = .02). Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05). No adverse events occurred.
CONCLUSIONS


Level 2b should be omitted in SND when this is oncologically safe and feasible. This allows for an optimal balance between function and cancer cure.",2020,Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05).,"['Forty patients were enrolled, and 30 were included (15 per group', 'Shoulder function after level 2b neck dissection', 'Patients with head and neck cancers undergoing surgery']","['SND without level 2b dissection (group 1) or with it (group 2) on their dominant-hand side', 'Selective neck dissection (SND']","['shoulder strength and range of motion (ROM) and SAN nerve conduction', 'change in the Neck Dissection Impairment Index (NDII) score', 'NDII', 'Shoulder ROM and SAN conduction', 'shoulder-related quality of life and function', 'adverse events', 'NDII score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand (attribute)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0398397', 'cui_str': 'Selective neck dissection of cervical lymph nodes (procedure)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027788', 'cui_str': 'Nerve Conduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.647647,Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05).,"[{'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Dziegielewski', 'Affiliation': 'Department of Otolaryngology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Ashworth', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': ""O'Connell"", 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Barber', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brock J', 'Initials': 'BJ', 'LastName': 'Debenham', 'Affiliation': 'Department of Radiation Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Seikaly', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}]",Cancer,['10.1002/cncr.32681']
469,32162278,A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.,"PURPOSE


In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.
METHODS


This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.
RESULTS


In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.
CONCLUSIONS


This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.",2020,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","['positional obstructive sleep apnea patients', '36 patients were included and all completed the titration protocol after 3 months', 'patients with POSA.\nMETHODS', 'patients with positional obstructive sleep apnea (POSA', 'patients with mild to moderate POSA']","['oral appliance therapy (OAT', 'OAT intervention']","['median objective adherence', 'Mean apnea-hypopnea index', 'good OAT tolerance']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",36.0,0.0493953,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","[{'ForeName': 'M H T', 'Initials': 'MHT', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.h.deruiter@amsterdamumc.nl.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02045-w']
470,31699734,Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.,"OBJECTIVES


During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.
DESIGN


Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.
SETTING


Thirty-three UK general practices in three areas.
PARTICIPANTS


The trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.
RESULTS


Staff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from 'tick-box' to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
CONCLUSIONS


Implementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.
TRIAL REGISTRATION NUMBER


ISRCTN06180958.",2019,"Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
","['Thirty-three UK general practices in three areas', '1546 people with multimorbidity', 'people with multimorbidity, including continuity of care and comprehensive biennial reviews', '11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview']",['inadequate skills training to implement patient-centred care planning'],[],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",[],1546.0,0.1225,"Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
","[{'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Mann', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK cindy.mann@bristol.ac.uk.'}, {'ForeName': 'Ali R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Guthrie', 'Affiliation': 'Division of Population Health Sciences, University of Dundee, Dundee, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Wye', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mei-See', 'Initials': 'MS', 'LastName': 'Man', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chaplin', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Salisbury', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031438']
471,30821168,"Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa.","HIV-infected women who have experienced sexual violence face unique challenges in their HIV care engagement and adherence to antiretroviral medications (ARVs). Improving AIDS Care after Trauma (ImpACT) is a brief counseling intervention aimed at reducing the negative impact of sexual trauma and HIV, building coping skills, and improving long-term HIV care engagement. We conducted a randomized controlled pilot trial of ImpACT with 64 women initiating ARVs in Cape Town, South Africa, with results suggesting the intervention can reduce PTSD symptoms and increase motivation to adhere to ARVs. For the current study, we abstracted data from ImpACT worksheets completed by 31 participants during intervention sessions, and qualitative responses from post-intervention surveys, to examine mechanisms, facilitators, and barriers to change in the intervention. Data included participant descriptions of the values informing their care, barriers to participation, and perceived benefits of the intervention related to coping with trauma and improving care engagement. During the first session, women reported feelings of shame, sadness, and anger that led to social isolation, mistrust, and damaged relationships. Barriers to participation included work and school demands, issues with transportation, finances, and discomfort in talking about HIV and trauma, particularly in group sessions. Despite these challenges, several women stated they developed more positive thinking, felt more confident, and improved their interpersonal relationships. Participants also reported substantial positive impact on symptoms of sexual trauma and motivation to continue with long-term HIV care, and clearer understanding of barriers and facilitators to ARV adherence. ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting. The data also offer insights into strategies to strengthen the intervention, overcome barriers to participation, encourage the practical application of skills, and promote long-term HIV care engagement.",2019,"ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting.","['64 women initiating ARVs in Cape Town, South Africa', 'HIV-infected women who have experienced sexual violence', 'Cape Town, South Africa', 'women with a history of trauma in this high-risk setting']",[],"['symptoms of sexual trauma and motivation to continue with long-term HIV care', 'coping with trauma and improving care engagement', 'PTSD symptoms and increase motivation to adhere to ARVs', 'feelings of shame, sadness, and anger that led to social isolation, mistrust, and damaged relationships']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation (finding)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]",64.0,0.0470416,"ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Knettel', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Knippler', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}, {'ForeName': 'Nonceba', 'Initials': 'N', 'LastName': 'Ciya', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'Corné', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town , Cape Town , South Africa.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Sikkema', 'Affiliation': 'Duke Global Health Institute, Duke University , Durham , NC , USA.'}]",AIDS care,['10.1080/09540121.2019.1587368']
472,32175973,Significant Dose-Response between Exercise Adherence and Hemoglobin A1c Change.,"INTRODUCTION


The Diabetes Aerobic and Resistance Exercise trial found that aerobic training and resistance training alone each reduced hemoglobin A1c (HbA1c) compared with nonexercising controls, and combined aerobic and resistance training caused greater HbA1c reduction than either training type alone. Our objective was to determine whether a dose-response relationship existed between frequency of exercise training and HbA1c change, and whether this varied by exercise modality or participant characteristics.
METHODS


Post hoc analysis of data from 185 Diabetes Aerobic and Resistance Exercise trial participants with type 2 diabetes randomized to aerobic, resistance or combined training thrice weekly. Dose-response relationships between adherence (percent of prescribed training sessions completed) and HbA1c change were assessed with linear regression.
RESULTS


Median overall adherence was 84.9% (interquartile range, 74.4%-93.6%). Higher exercise adherence was associated with greater HbA1c reduction; a 20% increase in adherence (e.g., an additional two sessions per month) was associated with a 0.15% (2 mmol·mol) decrease in HbA1c (β = -0.0076, R = -0.170, P = 0.021). Significant dose-response relationships were identified for aerobic (β = -0.0142, R = -0.313, P = 0.016) and combined training (β = -0.0109, R = -0.259, P = 0.041), but not resistance training (β = 0.0068, R = 0.153, P = 0.233). Dose-response relationships in all training groups combined were significant in subgroups younger than 55 yr (β = -0.0113, R = -0.286, P = 0.005), males (β = -0.0123, R = -0.234, P = 0.010), and baseline HbA1c ≥7.5% (58 mmol·mol) (β = -0.013, R = -0.263, P = 0.011).
CONCLUSIONS


There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume. Dose-response relationships existed for aerobic and combined training but not resistance training. These findings support aerobic and combined exercise prescriptions outlined in clinical practice guidelines.",2020,There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume.,"['Post-hoc analysis of data from 185 DARE trial participants with type 2 diabetes randomized to aerobic, resistance or combined training thrice weekly']",['aerobic training and resistance training'],"['Median overall adherence', 'Higher exercise adherence', 'HbA1c reduction', 'adherence']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0444395,There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Benham', 'Affiliation': '1Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 2Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 3Departments of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 4Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, CANADA 5Faculty of Kinesiology, Sport, and Recreation, Alberta Diabetes Institute, University of Alberta, Edmonton, AB, CANADA 6School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, CANADA 7Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, CANADA 8Institut du Savoir Montfort, Ottawa, ON, CANADA 9Department of Cardiac Sciences and Faculty of Kinesiology, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Booth', 'Affiliation': ''}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Dunbar', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': ''}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'BoulÉ', 'Affiliation': ''}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""Prud'homme"", 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002339']
473,31999839,Long-term results of frontline dasatinib in chronic myeloid leukemia.,"BACKGROUND


Dasatinib is a second-generation tyrosine kinase inhibitor that, when used as frontline therapy, produces more and faster cytogenetic and molecular responses compared with imatinib. The authors report the long-term follow-up from the first study using dasatinib as initial therapy for chronic-phase chronic myeloid leukemia.
METHODS


Between November 2005 and August 2014, patients were randomly assigned to receive 100 mg daily or 50 mg twice daily. After June 2009, all patients started with 100 mg daily.
RESULTS


With a median follow-up of 6.5 years, 94 of 149 treated patients (63%) were still receiving dasatinib on study. The median patient age was 48 years (interquartile range, 37-55 years), and 9% of patients had a high risk Sokal risk score. The cumulative complete cytogenetic response rate at 11 years was 92.6%, the major molecular response (MR) rate was 88.2%, and the MR4.5 rate (indicating a ≥4.5-log reduction in BCR-ABL1 transcripts) was 79.5%. The median time to a major MR and MR4.5 was 6 and 23 months, respectively. A sustained MR4.5 (≥2 years) was achieved in 82 patients (55%). The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively. Univariate analysis showed that the achievement of a complete MR was associated with improved overall survival. The most common reasons for treatment discontinuation were toxicity and elective discontinuation. The most common treatment-emergent grade 3 and 4 adverse events were fatigue, thrombocytopenia, and infections.
CONCLUSIONS


After this long-term follow-up, dasatinib continues to show an excellent safety profile and produces rapid cytogenetic responses and MRs, durable deep MRs, and excellent long-term survival outcomes in patients with chronic-phase chronic myeloid leukemia.",2020,"The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively.","['chronic myeloid leukemia', 'The median patient age was 48\xa0years (interquartile range, 37-55\xa0years), and 9% of patients had a high risk Sokal risk score', 'Between November 2005 and August 2014', 'chronic-phase chronic myeloid leukemia', 'With a median follow-up of 6.5\xa0years, 94 of 149 treated patients (63%) were still receiving dasatinib on study', 'patients with chronic-phase chronic myeloid leukemia']",['100\xa0mg daily or 50\xa0mg twice daily'],"['cumulative complete cytogenetic response rate', 'toxicity and elective discontinuation', 'MR4.5 rate', 'rapid cytogenetic responses and MRs, durable deep MRs, and excellent long-term survival outcomes', 'median time to a major MR and MR4.5', 'fatigue, thrombocytopenia, and infections', 'overall survival', '10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates', 'major molecular response (MR) rate']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023474', 'cui_str': 'Granulocytic Leukemia, Chronic, Stable-Phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.12634,"The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively.","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Maiti', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Keyur P', 'Initials': 'KP', 'LastName': 'Patel', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Masarova', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Graciela M', 'Initials': 'GM', 'LastName': 'Nogueras-González', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Skinner', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Poku', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'DellaSala', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rajyalakshmi', 'Initials': 'R', 'LastName': 'Luthra', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, California.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32627']
474,31520895,"Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE): Rationale, design, and methods.","BACKGROUND


The benefits of aerobic exercise (AE) for cardiovascular disease (CVD) have been well documented. Resistance exercise (RE) has been traditionally examined for its effects on bone density, physical function, or metabolic health, yet few data exist regarding the benefits of RE, independent of and combined with AE, for CVD prevention. This randomized controlled trial, ""Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE),"" is designed to determine the relative benefits of RE, AE, or combined RE plus AE training on CVD risk factors.
METHODS


Participants are 406 inactive men and women (35-70 years) with a body mass index of 25-40 kg/m 2  and blood pressure (BP) of 120-139/80-89 mm Hg without taking antihypertensive medications. Participants are randomly assigned to RE only, AE only, combined RE and AE (CE), or a no exercise control group. Participants perform supervised exercise at 50%-80% of their relative maximum intensity for both AE and RE, 3 times a week for 60 minutes per session, for 1 year (all 3 groups are time matched).
RESULTS


The primary outcome is a composite z score including resting BP, low-density lipoprotein cholesterol (LDL-C), fasting glucose, and percent body fat, which is assessed at baseline, 6 months, and 12 months. Diet and outside physical activity are measured throughout the intervention for 1 year.
CONCLUSION


CardioRACE (ClinicalTrials.govNCT03069092) will fill an important knowledge gap regarding the effects of RE, alone or in addition to the well-documented effects of AE. CardioRACE will help generate more comprehensive and synergistic clinical and public health strategies to prevent CVD.",2019,"This randomized controlled trial, ""Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE),"" is designed to determine the relative benefits of RE, AE, or combined RE plus AE training on CVD risk factors.
",['Participants are 406 inactive men and women (35-70\u202fyears) with a body mass index of 25-40\u202fkg/m 2  and blood pressure (BP) of 120-139/80-89\u202fmm Hg without taking antihypertensive medications'],"['RE plus AE training', 'Resistance exercise (RE', 'Resistance, Aerobic, and Combined Exercise (CardioRACE', 'AE only, combined RE and AE (CE), or a no exercise control group', 'CardioRACE (ClinicalTrials.govNCT03069092', 'CardioRACE', 'aerobic exercise (AE']","['composite z score including resting BP, low-density lipoprotein cholesterol (LDL-C), fasting glucose, and percent body fat']","[{'cui': 'C2000529', 'cui_str': 'WAS406'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",406.0,0.355664,"This randomized controlled trial, ""Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE),"" is designed to determine the relative benefits of RE, AE, or combined RE plus AE training on CVD risk factors.
","[{'ForeName': 'Angelique G', 'Initials': 'AG', 'LastName': 'Brellenthin', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA.'}, {'ForeName': 'Lorraine M', 'Initials': 'LM', 'LastName': 'Lanningham-Foster', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Kohut', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Statistics, University of California-Riverside, Riverside, CA.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Department of Preventive Medicine, Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Duck-Chul', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA. Electronic address: dclee@iastate.edu.'}]",American heart journal,['10.1016/j.ahj.2019.08.008']
475,31530607,Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial.,"INTRODUCTION


Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants.
METHODS AND ANALYSIS


Very low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks' postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of -210 g.
ETHICS AND DISSEMINATION


The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03730883.
PROTOCOL VERSION


Version 3. 14.08.2019.",2019,The primary outcome measure will be the difference between the two groups in weight at 36 weeks' postmenstrual age.,"['Eligible infants', 'very low birthweight premature infants', 'Very low birthweight premature infants will be recruited', 'preterm infants']",['standard central line removal'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",[],,0.212874,The primary outcome measure will be the difference between the two groups in weight at 36 weeks' postmenstrual age.,"[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Romańska', 'Affiliation': 'Division of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Margas', 'Affiliation': 'HTA Consulting, Cracow, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Bokiniec', 'Affiliation': 'Neonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Krajewski', 'Affiliation': 'Division of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Seliga-Siwecka', 'Affiliation': 'Neonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, Poland joanna.seliga@wum.edu.pl.'}]",BMJ open,['10.1136/bmjopen-2019-030167']
476,31530608,Effectiveness of a behavioural intervention involving regular weighing and feedback by community midwives within routine antenatal care to prevent excessive gestational weight gain: POPS2 randomised controlled trial.,"OBJECTIVES


To assess the effectiveness of a brief behavioural intervention based on routine antenatal weighing to prevent excessive gestational weight gain (defined by US Institute of Medicine).
DESIGN


Randomised controlled trial.
SETTING


Antenatal clinic in England.
PARTICIPANTS


Women between 10 +0  and 14 +6  weeks gestation, not requiring specialist obstetric care.
INTERVENTIONS


Participants were randomised to usual antenatal care or usual care (UC) plus the intervention. The intervention involved community midwives weighing women at antenatal appointments, setting maximum weight gain limits between appointments and providing brief feedback. Women were encouraged to monitor and record their own weight weekly to assess their progress against the maximum limits set by their midwife. The comparator was usual maternity care.
PRIMARY AND SECONDARY OUTCOME MEASURES


Excessive gestational weight gain, depression, anxiety and physical activity.
RESULTS


Six hundred and fifty-six women from four maternity centres were recruited: 329 women were randomised to the intervention group and 327 to UC. We found no evidence that the intervention decreased excessive gestational weight gain. At 38 weeks gestation, the proportions gaining excessive gestational weight were 27.6% (81/305) versus 28.9% (90/311) (adjusted OR 0.84, 95% CI: 0.53 to 1.33) in the intervention and UC group, respectively. There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean -0.58, 95% CI:-1.25 to -0.8; depression: adjusted mean -0.60, 95% CI:-1.24 to -0.05). There were no significant differences in physical activity scores between the groups.
CONCLUSIONS


A behavioural intervention delivered by community midwives involving routine weighing throughout pregnancy, setting maximum weight gain targets and encouraging women to weigh themselves each week to check progress did not prevent excessive gestational weight gain. There was no evidence of psychological harm.
TRIAL REGISTRATION NUMBER


ISRCTN67427351.",2019,"There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean -0.58, 95% CI:-1.25 to -0.8; depression: adjusted mean -0.60, 95% CI:-1.24 to -0.05).","['Six hundred and fifty-six women from four maternity centres were recruited: 329 women', 'Antenatal clinic in England', 'Women between 10 +0  and 14 +6  weeks gestation, not requiring specialist obstetric care', 'community midwives weighing women at antenatal appointments']","['usual antenatal care or usual care (UC) plus the intervention', 'behavioural intervention']","['excessive gestational weight gain', 'proportions gaining excessive gestational weight', 'Excessive gestational weight gain, depression, anxiety and physical activity', 'anxiety or depression scores (anxiety', 'physical activity scores']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0401997', 'cui_str': 'Community midwife (occupation)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",656.0,0.203227,"There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean -0.58, 95% CI:-1.25 to -0.8; depression: adjusted mean -0.60, 95% CI:-1.24 to -0.05).","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK a.daley@lboro.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research,College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roalfe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Mackilllop', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, John Radcliffe Hospital, Oxford, UK.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Clifford', 'Affiliation': 'Institute of Applied Health Research,College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Usman', 'Affiliation': 'Institute of Applied Health Research,College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Corah', 'Initials': 'C', 'LastName': 'Ohadike', 'Affiliation': 'Sherwood Forest Hospitals NHS FoundationTrust, Nottinghamshire, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kenyon', 'Affiliation': 'Institute of Applied Health Research,College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'MacArthur', 'Affiliation': 'Institute of Applied Health Research,College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030174']
477,31530612,Ambulatory cancer care electronic symptom self-reporting (ACCESS) for surgical patients: a randomised controlled trial protocol.,"INTRODUCTION


An increasing proportion of cancer surgeries are ambulatory procedures requiring a stay of 1 day or less in the hospital. Providing patients and their caregivers with ongoing, real-time support after discharge aids delivery of high-quality postoperative care in this new healthcare environment. Despite abundant evidence that patient self-reporting of symptoms improves quality of care, the most effective way to monitor and manage this self-reported information is not known.
METHODS AND ANALYSIS


This is a two-armed randomised, controlled trial evaluating two approaches to the management of patient-reported data: (1) team monitoring, symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback, real-time feedback to patients about expected symptom severity, with patient-activated care as needed.Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750) complete an electronic survey for up to 30 days after surgery that includes items from a validated instrument developed by the National Cancer Institute, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Information provided to patients in the Enhanced Feedback group is procedure-specific and based on updated PRO-CTCAE data from previous patients. Qualitative interviews are also performed. The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).
ETHICS AND DISSEMINATION


This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. The relationships between the study team and stakeholders will be leveraged to disseminate study findings. Findings will be relevant in designing future coordinated care models targeting improved healthcare quality and patient experience.
TRIAL REGISTRATION NUMBER


NCT03178045.",2019,"The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).
","['Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750', 'surgical patients']",['Ambulatory cancer care electronic symptom self-reporting (ACCESS'],"['unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0920424'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.14972,"The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).
","[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Stabile', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Temple', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Ancker', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Department of Health Policy and Management, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Magen', 'Initials': 'M', 'LastName': 'Miranda', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Stetson', 'Affiliation': 'Division of Health Informatics, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA simonb1@mskcc.org.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Pusic', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-030863']
478,32162321,Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial.,"BACKGROUND


Surgical-site infection (SSI) increases treatment costs, duration of hospital stay and readmission rate after pancreatic surgery. This study aimed to assess whether a wound protector could reduce the risk of superficial incisional SSI after pancreatoduodenectomy.
METHODS


This RCT included patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018. The experimental group had a dual-ring wound protector, whereas the control group had standard surgical drapes. The groups were stratified by preoperative biliary stent placement. The primary outcome was the overall rate of superficial SSI.
RESULTS


An interim analysis was conducted after 212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention. Some 94 patients (49·5 per cent) had a wound protector and 96 (50·5 per cent) had standard drapes. There were no differences between groups in demographics, or in intraoperative findings, pathological data or surgical outcomes. The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585). Subanalysis of patients with a preoperative biliary stent showed a similar outcome (superficial SSI rate 9 versus 8 per cent with wound protector versus surgical drapes respectively; P = 0·536). The trial was stopped prematurely on the grounds of futility.
CONCLUSION


Use of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 (http://www.clinicaltrials.gov).",2020,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","['patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018', '212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention', 'after pancreatic surgery']","['preoperative biliary stent placement', 'intraoperative wound protector', 'dual-ring wound protector', 'control group had standard surgical drapes', 'wound protector']","['treatment costs, duration of hospital stay and readmission rate', 'overall superficial SSI rate', 'similar outcome (superficial SSI rate', 'rate of superficial SSI', 'risk of superficial incisional SSI', 'overall rate of superficial SSI', 'intraoperative findings, pathological data or surgical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180511', 'cui_str': 'Surgical Drapes'}]","[{'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.26657,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fontana', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Secchettin', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manzini', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}]",The British journal of surgery,['10.1002/bjs.11527']
479,32159834,Does Changing Residency Obstetric Call to a Group Model Significantly Impact Patient Continuity?,"BACKGROUND AND OBJECTIVES


Group sharing of prenatal care and inpatient obstetric (OB) call is increasingly replacing single-provider longitudinal models including in family medicine (FM) residencies. Such change in care models could impact continuity of prenatal and delivery care.The University of Rochester's family medicine residency program changed the resident maternal care coverage to an obstetric group model from a single-provider model in 2016 to improve work-life balance, which provided an opportunity to examine how these two practice styles impacted provider continuity.
METHODS


We performed a retrospective chart review of family medicine resident-assigned obstetric patients receiving care at the University of Rochester's residency clinic. The study evaluated provider continuity differences in two models of prenatal care and obstetric call: (1) single provider model (SPM) with one primary provider and one backup support resident vs (2) OB group-provider model (GPM) with three to four resident providers and one primary provider.
RESULTS


The average number of different providers seen significantly increased in the GPM vs SPM (3.47 vs 2.87, P=.02), however the average percentage of prenatal visits with either a primary or designated backup provider was not statistically different (83.1% vs 90.1%, P=.07). Among delivery continuity measures, there was no significant difference between models in the percentage of deliveries attended by the primary or designated backup residents compared with nongroup providers. (76.9% vs 82.3%, P=.51).
CONCLUSIONS


This study provides quantitative evidence on how differing models of residency maternal care coverage impact continuity of care. Study findings did not show an inferiority of an OB group-provider model compared to a single-provider model when considering how often patients were seen prenatally and delivered by providers from their continuity group.",2020,Study findings did not show an inferiority of an OB group-provider model compared to a single-provider model when considering how often patients were seen prenatally and delivered by providers from their continuity group.,"[""family medicine resident-assigned obstetric patients receiving care at the University of Rochester's residency clinic""]",['prenatal care and obstetric call: (1) single provider model (SPM) with one primary provider and one backup support resident vs (2) OB group-provider model (GPM) with three to four resident providers and one primary provider'],"['average percentage of prenatal visits', 'average number of different providers seen']","[{'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1827763', 'cui_str': 'Prenatal visit (regime/therapy)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.024351,Study findings did not show an inferiority of an OB group-provider model compared to a single-provider model when considering how often patients were seen prenatally and delivered by providers from their continuity group.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Cowen', 'Affiliation': 'University of Rochester Family Medicine Residency, Rochester, NY.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Loomis', 'Affiliation': 'University of Rochester Family Medicine Residency, Rochester, NY.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'University of Rochester Family Medicine Residency, Rochester, NY.'}]",Family medicine,['10.22454/FamMed.2020.436708']
480,31936621,"Does Acute Beetroot Juice Supplementation Improve Neuromuscular Performance and Match Activity in Young Basketball Players? A Randomized, Placebo-Controlled Study.","Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in team sports has been barely studied. In this randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance and physical match activity in basketball. Ten young male competitive basketball players aged 15-16 years received 140 mL of BJ or placebo (PLA) on two separated days in a balanced cross-over design. Testing sessions comprised a neuromuscular test battery consisting of a countermovement jump (CMJ), isometric handgrip strength, 10-m/20-m sprint and agility T-test, followed by a 40-minute simulated basketball match. Physical match activity (distances, speeds, accelerations, and decelerations) was monitored using an inertial tracking system (Wimu Pro TM ) Results revealed no significant effects of BJ on CMJ ( p  = 0.304, ES = 0.13), isometric handgrip strength ( p  = 0.777, ES = 0.06), 10-m ( p  = 0.820, ES = 0.10), and 20-m sprint ( p  = 0.540, ES = 0.13), agility T-test ( p  = 0.979, ES ≤ 0.01) and any physical match demands ( p  > 0.151, ES = 0.13-0.48). Acute moderate doses of BJ (12.8 mmol of NO 3 - ) was not effective in improving neuromuscular performance (jump height, isometric handgrip strength, sprint, and agility) or physical match requirements in young trained basketball players the day of the competition.",2020,"Physical match activity (distances, speeds, accelerations, and decelerations) was monitored using an inertial tracking system (Wimu Pro TM )","['Young Basketball Players', 'basketball', 'Ten young male competitive basketball players aged 15-16 years received']","['Placebo', '140 mL of BJ or placebo (PLA', 'BJ acute supplementation', 'Acute Beetroot Juice Supplementation', 'placebo', 'neuromuscular test battery consisting of a countermovement jump (CMJ), isometric handgrip strength, 10-m/20-m sprint and agility T-test, followed by a 40-minute simulated basketball match', 'beetroot juice (BJ) supplementation', 'BJ']","['inertial tracking system (Wimu Pro TM ', 'Physical match activity (distances, speeds, accelerations, and decelerations', 'neuromuscular performance (jump height, isometric handgrip strength, sprint, and agility) or physical match requirements', 'BJ on CMJ', 'neuromuscular performance and physical match activity', 'isometric handgrip strength', 'agility T-test', 'Neuromuscular Performance and Match Activity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1738334', 'cui_str': 'Tracking system'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",10.0,0.0776422,"Physical match activity (distances, speeds, accelerations, and decelerations) was monitored using an inertial tracking system (Wimu Pro TM )","[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Aarón', 'Initials': 'A', 'LastName': 'Gómez Parra', 'Affiliation': 'Faculty of Sport Sciences, University of Murcia, 30720 Murcia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno-Pérez', 'Affiliation': 'Center for Translational Research in Physiotherapy, Department of Pathology and Surgery. Universidad Miguel Hernández, Elche, 03550 San Juan, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Courel-Ibáñez', 'Affiliation': 'Faculty of Sport Sciences, University of Murcia, 30720 Murcia, Spain.'}]",Nutrients,['10.3390/nu12010188']
481,31977010,Validation of European Society of Cardiology pre-test probabilities for obstructive coronary artery disease in suspected stable angina.,"AIMS 


To assess contemporary pre-test probability estimates for obstructive coronary artery disease in patients with stable chest pain.
METHODS AND RESULTS 


In this substudy of a multicentre randomized controlled trial, we compared 2019 European Society of Cardiology (ESC)-endorsed pre-test probabilities with observed prevalence of obstructive coronary artery disease on computed tomography coronary angiography (CTCA). We assessed associations between pre-test probability, 5-year coronary heart disease death or non-fatal myocardial infarction and study intervention (standard care vs. CTCA). The study population consisted of 3755 patients (30-75 years, 46% women) with a median pre-test probability of 11% of whom 1622 (43%) had a pre-test probability of >15%. In those who underwent CTCA (n = 1613), the prevalence of obstructive disease was 22%. When divided into deciles of pre-test probability, the observed disease prevalence was similar but higher than the corresponding median pre-test probability [median difference 2.3 (1.3-5.6)%]. There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5%, and 1.4%, respectively, P < 0.001). Across the total cohort, fewer clinical events occurred in patients who underwent CTCA, with the greatest difference in those with a pre-test probability >15% (2.8% vs. 5.3%, log rank P = 0.01), although this interaction was not statistically significant on multivariable modelling.
CONCLUSION 


The updated 2019 ESC guideline pre-test probability recommendations tended to slightly underestimate disease prevalence in our cohort. Pre-test probability is a powerful predictor of future coronary events and helps select those who may derive the greatest absolute benefit from CTCA.",2020,"There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5% and 1.4% respectively, p < 0.001).","['obstructive coronary artery disease in suspected stable angina', '3755 patients (30-75 years, 46% women) with a median pre-test probability of 11% of whom 1622 (43%) had a pre-test probability >15', 'patients with stable chest pain', '2019 European Society of Cardiology (ESC)-endorsed pre-test probabilities with observed prevalence of obstructive coronary artery disease on computed tomography coronary angiography (CTCA']",['CTCA'],"['clinical events', 'pre-test probability, 5-year coronary heart disease death or non-fatal myocardial infarction', 'prevalence of obstructive disease']","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",3755.0,0.0861506,"There were more clinical events in patients with a pre-test probability >15% compared to those at 5-15% and <5% (4.1%, 1.5% and 1.4% respectively, p < 0.001).","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcaa006']
482,30066133,Co-thought gesturing supports more complex problem solving in subjects with lower visual working-memory capacity.,"During silent problem solving, hand gestures arise that have no communicative intent. The role of such co-thought gestures in cognition has been understudied in cognitive research as compared to co-speech gestures. We investigated whether gesticulation during silent problem solving supported subsequent performance in a Tower of Hanoi problem-solving task, in relation to visual working-memory capacity and task complexity. Seventy-six participants were assigned to either an instructed gesture condition or a condition that allowed them to gesture, but without explicit instructions to do so. This resulted in three gesture groups: (1) non-gesturing; (2) spontaneous gesturing; (3) instructed gesturing. In line with the embedded/extended cognition perspective on gesture, gesturing benefited complex problem-solving performance for participants with a lower visual working-memory capacity, but not for participants with a lower spatial working-memory capacity.",2020,"We investigated whether gesticulation during silent problem solving supported subsequent performance in a Tower of Hanoi problem-solving task, in relation to visual working-memory capacity and task complexity.","['Seventy-six participants', 'subjects with lower visual working-memory capacity']","['instructed gesture condition or a condition that allowed them to gesture, but without explicit instructions to do so']",[],"[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",[],76.0,0.0491537,"We investigated whether gesticulation during silent problem solving supported subsequent performance in a Tower of Hanoi problem-solving task, in relation to visual working-memory capacity and task complexity.","[{'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Eielts', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Pouw', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands. pouw@essb.eur.nl.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ouwehand', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'van Gog', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Zwaan', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Paas', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3000 DR, Rotterdam, The Netherlands.'}]",Psychological research,['10.1007/s00426-018-1065-9']
483,32159454,Lymphedema Surveillance and Patient-Reported Anxiety: Comparison Between Volumetric Assessment and Bioimpedance Analysis.,"Background:  Lymphedema is a complication of breast cancer therapy associated with substantial anxiety. We designed a prospective, randomized study to assess the psychosocial impact of different surveillance methods for lymphedema.  Methods and Results:  In this open-label study of 38 women undergoing breast cancer surgery, we screened for lymphedema using traditional volumetric measurements (circumferential readings from the wrist to the axilla) versus bioimpedance spectroscopy (BIS) using electric current. The primary outcome measure was total anxiety measured by the Beck Anxiety Inventory, a 21-item questionnaire administered at preoperative, 6-week, 3-month, and 6-month postoperative visits (range 0-63 points). Outcome metrics were compared after adjustment for baseline anxiety. There were no differences in clinical characteristics or cancer therapies between groups, except for more reoperation for positive surgical margins in the BIS patients (5% vs. 32%,  p  = 0.036). Baseline anxiety, depression, and associated medical therapies were similar as well. Only one woman in each group developed lymphedema during the study. Anxiety was higher in the BIS group at baseline (mean Beck score 12.2 vs. 7.2,  p  < 0.001), but anxiety levels gradually declined by the end of the 6-month study in both groups, with no differences in adjusted anxiety scores between the two groups at any time point during follow-up (all  p  = NS).  Conclusions:  In this pilot study of women scheduled for breast cancer surgery, most subjects reported mild anxiety at baseline, and anxiety levels fell during continued lymphedema surveillance visits. There was no difference in patient-reported anxiety when surveillance was performed using standard volumetric versus BIS measurements.",2020,"There were no differences in clinical characteristics or cancer therapies between groups, except for more reoperation for positive surgical margins in the BIS patients (5% vs. 32%,  p  = 0.036).","['38 women undergoing breast cancer surgery', 'Lymphedema Surveillance and Patient-Reported Anxiety', 'women scheduled for breast cancer surgery, most subjects reported mild anxiety at baseline, and anxiety levels fell during continued lymphedema surveillance visits']",['lymphedema using traditional volumetric measurements (circumferential readings from the wrist to the axilla) versus bioimpedance spectroscopy (BIS) using electric current'],"['reoperation for positive surgical margins', 'adjusted anxiety scores', 'Baseline anxiety, depression, and associated medical therapies', 'patient-reported anxiety', 'lymphedema', 'Anxiety', 'clinical characteristics or cancer therapies', 'total anxiety measured by the Beck Anxiety Inventory, a 21-item questionnaire administered at preoperative, 6-week, 3-month, and 6-month postoperative visits', 'anxiety levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety (finding)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",38.0,0.0618772,"There were no differences in clinical characteristics or cancer therapies between groups, except for more reoperation for positive surgical margins in the BIS patients (5% vs. 32%,  p  = 0.036).","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Stolker', 'Affiliation': 'Mercy Integrative Medicine, David C. Pratt Cancer Center, St. Louis, Missouri.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Stolker', 'Affiliation': 'Mercy Clinic Heart and Vascular, Washington and St. Louis, Missouri.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Radford', 'Affiliation': 'Department of Breast Services, Digestive Diseases and Surgery Institute, Cleveland Clinic, Cleveland, Ohio.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0077']
484,32151528,Monitoring ocular discomfort using a wrist-mounted electronic logger.,"PURPOSE


To investigate ocular discomfort during contact lens wear using a wrist-mounted electronic 'lens awareness logger' (LAL).
METHODS


Thirty symptomatic contact lens wearers wore study contact lenses for three days. On the first two days, two lens types which are known to differ in end-of-day comfort (lens A: senofilcon A and lens B: balafilcon A), were worn as a matching pair (randomised order). On day three, a pair of lens B was worn. On each day, the participant used a LAL. On day one and two, the participant pressed a button on the LAL whenever they became aware of their lenses due to discomfort. On day three, the participant used a multiple click protocol (1 = mild awareness to 3 = severe awareness) to report discomfort.
RESULTS


LAL events were similar on days one and two (17.3 vs. 15.8 events per day). There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006). The LAL event profile highlighted peaks in awareness following lens application and towards the end of the wearing cycle. Comparison of the LAL event profile for the two lens types showed significant differences in lens awareness, particularly in the first half of the wearing cycle. LAL events on day 3, showed a uniform distribution of single and double clicks through the day, but a marked peak in triple clicks in the last two hours of lens wear.
CONCLUSION


The LAL was able to differentiate between the study lenses and demonstrated differences in their LAL event profiles. Lens awareness associated with discomfort appeared to increase not only in frequency, but also in intensity towards the end of the wearing cycle. The ability of the LAL to track lens awareness suggests it is likely to be a useful tool in furthering understanding of ocular discomfort.",2020,There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006).,['Thirty symptomatic contact lens wearers'],[],"['LAL events', 'lens awareness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}]",[],"[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",30.0,0.0263298,There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006).,"[{'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Read', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK. Electronic address: michael.read-3@manchester.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Navascues-Cornago', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Keir', 'Affiliation': 'CooperVision Inc., 6150 Stoneridge Mall Rd, Pleasanton, California 94588, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Maldonado-Codina', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Morgan', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.010']
485,31432072,Plasma metabolomics profiles suggest beneficial effects of a low-glycemic load dietary pattern on inflammation and energy metabolism.,"BACKGROUND


Low-glycemic load dietary patterns, characterized by consumption of whole grains, legumes, fruits, and vegetables, are associated with reduced risk of several chronic diseases.
METHODS


Using samples from a randomized, controlled, crossover feeding trial, we evaluated the effects on metabolic profiles of a low-glycemic whole-grain dietary pattern (WG) compared with a dietary pattern high in refined grains and added sugars (RG) for 28 d. LC-MS-based targeted metabolomics analysis was performed on fasting plasma samples from 80 healthy participants (n = 40 men, n = 40 women) aged 18-45 y. Linear mixed models were used to evaluate differences in response between diets for individual metabolites. Kyoto Encyclopedia of Genes and Genomes (KEGG)-defined pathways and 2 novel data-driven analyses were conducted to consider differences at the pathway level.
RESULTS


There were 121 metabolites with detectable signal in >98% of all plasma samples. Eighteen metabolites were significantly different between diets at day 28 [false discovery rate (FDR) < 0.05]. Inositol, hydroxyphenylpyruvate, citrulline, ornithine, 13-hydroxyoctadecadienoic acid, glutamine, and oxaloacetate were higher after the WG diet than after the RG diet, whereas melatonin, betaine, creatine, acetylcholine, aspartate, hydroxyproline, methylhistidine, tryptophan, cystamine, carnitine, and trimethylamine were lower. Analyses using KEGG-defined pathways revealed statistically significant differences in tryptophan metabolism between diets, with kynurenine and melatonin positively associated with serum C-reactive protein concentrations. Novel data-driven methods at the metabolite and network levels found correlations among metabolites involved in branched-chain amino acid (BCAA) degradation, trimethylamine-N-oxide production, and β oxidation of fatty acids (FDR < 0.1) that differed between diets, with more favorable metabolic profiles detected after the WG diet. Higher BCAAs and trimethylamine were positively associated with homeostasis model assessment-insulin resistance.
CONCLUSIONS


These exploratory metabolomics results support beneficial effects of a low-glycemic load dietary pattern characterized by whole grains, legumes, fruits, and vegetables, compared with a diet high in refined grains and added sugars on inflammation and energy metabolism pathways. This trial was registered at clinicaltrials.gov as NCT00622661.",2019,"Higher BCAAs and trimethylamine were positively associated with homeostasis model assessment-insulin resistance.
","['80 healthy participants (n\xa0= 40 men, n = 40 women) aged 18-45 y. Linear mixed models']",['low-glycemic whole-grain dietary pattern (WG) compared with a dietary pattern high in refined grains and added sugars (RG) for 28 d. LC-MS-based targeted metabolomics analysis'],"['serum C-reactive protein concentrations', 'Inositol, hydroxyphenylpyruvate, citrulline, ornithine, 13-hydroxyoctadecadienoic acid, glutamine, and oxaloacetate', 'tryptophan metabolism', 'homeostasis model assessment-insulin resistance', 'inflammation and energy metabolism', 'false discovery rate (FDR', 'melatonin, betaine, creatine, acetylcholine, aspartate, hydroxyproline, methylhistidine, tryptophan, cystamine, carnitine, and trimethylamine']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0044837', 'cui_str': '13-hydroxyoctadecadienoic acid'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0220889', 'cui_str': 'oxaloacetate'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C1328418', 'cui_str': 'Hydroxyproline measurement'}, {'cui': 'C0025780', 'cui_str': 'Methylhistidines'}, {'cui': 'C0010637', 'cui_str': 'Cystamine'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}]",121.0,0.0570152,"Higher BCAAs and trimethylamine were positively associated with homeostasis model assessment-insulin resistance.
","[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Aliasghar', 'Initials': 'A', 'LastName': 'Tarkhan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shojaie', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Haiwei', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Danijel', 'Initials': 'D', 'LastName': 'Djukovic', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Osterbauer', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz169']
486,31577341,Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.,"Importance


Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.
Objective


To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis.
Design, Setting, and Participants


A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site.
Interventions


Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks.
Main Outcomes and Measures


The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12.
Results


Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4.
Conclusions and Relevance


Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety.
Trial Registration


ClinicalTrials.gov identifier: NCT02780167.",2019,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","['adults with moderate to severe atopic dermatitis', 'Patients With Atopic Dermatitis', '267 participants', 'patients with moderate to severe atopic dermatitis', 'April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months', '144 were women (mean [SD] age, 40.8 [16.1] years']","['placebo', 'Oral Janus Kinase 1 Inhibitor Abrocitinib', 'abrocitinib']","['adverse events', 'Adverse events', 'efficacy and safety', 'Efficacy', 'platelet count', 'percentage change from baseline in the Eczema Area and Severity Index', 'Efficacy and Safety', 'dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea', 'Eczema Area and Severity Index', ""Investigator's Global Assessment scale"", ""proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0169658', 'cui_str': 'Jak1 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]",144.0,0.596428,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Seth B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'Forward Clinical Trials, Tampa, Florida.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Department of Dermatology, Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Innovative Health Statistics, Pfizer Inc, New York, New York.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Papacharalambous', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.2855']
487,31310925,Subjective response to intranasal nicotine administration in oral contraceptive users and naturally-cycling women.,"INTRODUCTION


Approximately half of premenopausal women who smoke cigarettes also use hormonal contraceptives, with most using oral contraceptives (OCs). While research on the effects of endogenous hormones on smoking-related outcomes continues to expand, little is known about the influence of OCs on similar outcomes. We sought to explore differences in the subjective response to nicotine by OC use after stratifying by testing condition (e.g., smoking status).
METHODS


Participants were regular (≥5 cigarettes/day) smokers, classified into OC and naturally cycling (NC) groups. All participants completed four total lab sessions by smoking status (ad libitum smoking, acute smoking abstinence) and anticipated progesterone level (low progesterone week (LPW), high progesterone week (HPW)). Each lab session included self-administration of intranasal nicotine (Time 0 min), assessment of subjective response via the Subjective State Scale (-30 and + 5 min).
RESULTS


Compared to the NC group (n = 28), the OC group (n = 14) was younger (26.2 ± 1.1 versus 24.2 ± 1.1; p < 0.001) and had a lower Fagerström Test for Nicotine Dependence score (3.4 ± 0.5 versus 2.6 ± 0.5; p = 0.011). Progesterone-to-estradiol ratios varied significantly by group at three of the four time points (p < 0.05). During ad libitum smoking, the OC group had significantly lower craving after nicotine administration than the NC group (1.93 ± 0.33 versus 2.89 ± 0.23; p = 0.024). No other significant differences in subjective response were identified.
CONCLUSIONS


Despite significantly different hormone levels, group differences in subjective response to nicotine were relatively few. Additional research is needed to elucidate the mechanisms involved in these observations, as well as explore how they may influence cessation in women.",2019,Progesterone-to-estradiol ratios varied significantly by group at three of the four time points (p < 0.05).,"['oral contraceptive users and naturally-cycling women', 'premenopausal women who smoke cigarettes also use hormonal contraceptives, with most using oral contraceptives (OCs', 'Participants were regular (≥5 cigarettes/day) smokers, classified into OC and naturally cycling (NC) groups']","['intranasal nicotine', 'progesterone level (low progesterone week (LPW), high progesterone week (HPW']","['subjective response via the Subjective State Scale', 'Subjective response', 'lower craving', 'subjective response', 'Progesterone-to-estradiol ratios', 'lower Fagerström Test for Nicotine Dependence score']","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0128004,Progesterone-to-estradiol ratios varied significantly by group at three of the four time points (p < 0.05).,"[{'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Allen', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, University of Arizona, 3950 South Country Club Drive, Suite 330, Tucson, AZ 85714-2238, USA. Electronic address: aliciaallen@email.arizona.edu.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Friedrichsen', 'Affiliation': 'Professional Data Analysts, Inc, 219 Main Street SE, Suite 302, Minneapolis, MN 55414, USA. Electronic address: sfriedrichsen@pdastats.com.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Petersen', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA 90024, USA. Electronic address: npetersen@ucla.edu.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine & Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, Room A682, Minneapolis, MN 55455, USA. Electronic address: allen001@umn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106043']
488,31586510,Sugar-Sweetened Beverage Health Warnings and Purchases: A Randomized Controlled Trial.,"INTRODUCTION


Five U.S. states have proposed policies to require health warnings on sugar-sweetened beverages, but warnings' effects on actual purchase behavior remain uncertain. This study evaluated the impact of sugar-sweetened beverage health warnings on sugar-sweetened beverage purchases.
STUDY DESIGN


Participants completed one study visit to a life-sized replica of a convenience store in North Carolina. Participants chose six items (two beverages, two foods, and two household products). One item was randomly selected for them to purchase and take home. Participants also completed a questionnaire. Researchers collected data in 2018 and conducted analyses in 2019.
SETTING/PARTICIPANTS


Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week).
INTERVENTION


Research staff randomly assigned participants to a health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label).
MAIN OUTCOME MEASURES


The primary trial outcome was sugar-sweetened beverage calories purchased. Secondary outcomes included reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness).
RESULTS


All 400 participants completed the trial and were included in analyses. Health warning arm participants were less likely to be Hispanic and to have overweight/obesity than control arm participants. In intent-to-treat analyses adjusting for Hispanic ethnicity and overweight/obesity, health warnings led to lower sugar-sweetened beverage purchases (adjusted difference, -31.4 calories; 95% CI= -57.9, -5.0). Unadjusted analyses yielded similar results (difference, -32.9 calories; 95% CI= -58.9, -7.0). Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions. Trial arms did not differ on perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk.
CONCLUSIONS


Brief exposure to health warnings reduced sugar-sweetened beverage purchases in this naturalistic RCT. Sugar-sweetened beverage health warning policies could discourage sugar-sweetened beverage consumption.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03511937.",2019,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","['All 400 participants completed the trial and were included in analyses', '2018 and conducted analyses in 2019', 'Participants completed one study visit to a life-sized replica of a convenience store in North Carolina', 'Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week']","['Sugar-Sweetened Beverage Health Warnings and Purchases', 'health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label']","[""perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk"", 'sugar-sweetened beverage calories purchased', 'reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556977', 'cui_str': 'oz/week'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",400.0,0.148836,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina. Electronic address: agrummon@unc.edu.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Golden', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.019']
489,32151161,Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial.,"BACKGROUND


Women are more likely to suffer and die from cardiogenic shock (CS) as the most severe complication of acute myocardial infarction. Data concerning optimal management for women with CS are scarce. Aim of this study was to better define characteristics of women experiencing CS and to the influence of sex on different treatment strategies.
METHODS


In the CULPRIT-SHOCK trial (The Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock), patients with CS complicating acute myocardial infarction and multivessel coronary artery disease were randomly assigned to one of the following revascularization strategies: either percutaneous coronary intervention of the culprit-lesion-only or immediate multivessel percutaneous coronary intervention. Primary end point was composite of death from any cause or severe renal failure leading to renal replacement therapy within 30 days. We investigated sex-specific differences in general and according to the revascularization strategies.
RESULTS


Among all 686 randomized patients included in the analysis, 24% were women. Women were older and had more often diabetes mellitus and renal insufficiency, whereas they had less often history of previous acute myocardial infarction and smoking. After 30 days, the primary clinical end point was not significantly different between groups (56% women versus 49% men; odds ratio, 1.29 [95% CI, 0.91-1.84];  P =0.15). There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure ( P interaction =0.11). The primary end point occurred in 56% of women treated by the culprit-lesion-only strategy versus 42% men, whereas 55% of women and 55% of men in the multivessel percutaneous coronary intervention group.
CONCLUSIONS


Although women presented with a different risk profile, mortality and renal replacement were similar to men. Sex did not influence mortality and renal failure according to the different coronary revascularization strategies. Based on these data, women and men presenting with CS complicating acute myocardial infarction and multivessel coronary artery disease should not be treated differently. However, further randomized trials powered to address potential sex-specific differences in CS are still necessary. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01927549.",2020,There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure ( P interaction =0.11).,"['686 randomized patients included in the analysis, 24% were women', 'women with CS', 'women and men presenting with CS complicating acute myocardial infarction and multivessel coronary artery disease', 'patients with CS complicating acute myocardial infarction and multivessel coronary artery disease', 'Patients With Acute Myocardial Infarction and Cardiogenic Shock']",['percutaneous coronary intervention of the culprit-lesion-only or immediate multivessel percutaneous coronary intervention'],"['mortality and renal replacement', 'composite of death from any cause or severe renal failure leading to renal replacement therapy', 'mortality and renal failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",686.0,0.12177,There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure ( P interaction =0.11).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rubini Gimenez', 'Affiliation': 'From the Department of Internal Medicine/Cardiology, Heart Center Leipzig, Germany (M.R.G., S.D., H.T.).'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Germany (U.Z.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'From the Department of Internal Medicine/Cardiology, Heart Center Leipzig, Germany (M.R.G., S.D., H.T.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology/ Angiology/Intensive Care Medicine, University Heart Center Lübeck, Germany (S.d.W.-T., J.P., R.M.-S., G.F.).'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany (T.O., S.S.).'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Poess', 'Affiliation': 'Department of Internal Medicine/Cardiology/ Angiology/Intensive Care Medicine, University Heart Center Lübeck, Germany (S.d.W.-T., J.P., R.M.-S., G.F.).'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'German Center for Cardiovascular Research, Berlin, Germany (S.D., R.M.-S., G.F.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany (T.O., S.S.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'German Center for Cardiovascular Research, Berlin, Germany (S.D., R.M.-S., G.F.).'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stepinska', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland (J.S.).'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Internal Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Department of Cardiology, Sorbonne Université, Institut de Cardiologie (AP-HP), hôpital Pitié Salpêtrière, Paris, France (G.M.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Department of Cardiology, Manzoni Hospital, Lecco, Italy (S.S.).'}, {'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'Cardiology Department, University Hospital Basel, Switzerland (M.R.G., R.V.J.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'From the Department of Internal Medicine/Cardiology, Heart Center Leipzig, Germany (M.R.G., S.D., H.T.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008537']
490,31798196,Storied Lessons: Learning from Anger in Childhood by Narrating.,"We evaluated whether narrating anger-provoking events promoted learning from those events, as compared with other responses to anger, and whether the effectiveness of narrative depended on age. In addition, we tested relations between anger-reduction and learning and in a subset of participants, between narrative quality and learning. 248 youth (8 to 17 years old) recalled an anger-provoking experience, and were randomly assigned to one of four activities: recalling the event a second time, narrating the event, and distraction (via video game play or conversation). Youth then recalled the event one last time, and rated the extent to which they had learned from that event. Younger children reported more learning when they had narrated their experience. Older youth reported more learning when they had narrated the event more frequently prior to participation. Stronger reductions in anger following regulation were associated with greater self-reported learning. Finally, more elaborative and less resolved narratives were associated with greater self-reported learning.",2019,Stronger reductions in anger following regulation were associated with greater self-reported learning.,"['Older youth', '248 youth (8 to 17 years old) recalled an anger-provoking experience', 'Younger children']","['activities: recalling the event a second time, narrating the event, and distraction (via video game play or conversation']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",[],248.0,0.0286203,Stronger reductions in anger following regulation were associated with greater self-reported learning.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pasupathi', 'Affiliation': 'Department of Psychology, University of Utah.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wainryb', 'Affiliation': 'Department of Psychology, University of Utah.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Oldroyd', 'Affiliation': 'Department of Psychology, University of Utah.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bourne', 'Affiliation': 'Youth Learning Institute, Clemson University.'}]",International journal of behavioral development,['10.1177/0165025419844023']
491,31775518,Physical Activity as a Predictor of Clinical Trial Outcomes in Bipolar Depression: A Subanalysis of a Mitochondrial-Enhancing Nutraceutical Randomized Controlled Trial.,"OBJECTIVES


Individuals with bipolar disorder (BD) generally engage in low levels of physical activity (PA), and yet few studies have investigated the relationship between PA and change in BD symptom severity. The aim of this subanalysis of an adjunctive nutraceutical randomized controlled trial for the treatment of bipolar depression was to explore the relationship between PA, the active adjunctive treatments (a nutraceutical ""mitochondrial cocktail""), and clinical outcomes.
METHODS


Participants with bipolar depression were randomized to receive  N -acetylcysteine alone,  N -acetylcysteine with a combination of nutraceuticals (chosen for the potential to increase mitochondrial activity), or placebo for 16 weeks. Participants ( n  = 145) who completed the International Physical Activity Questionnaire-Short Form (IPAQ-SF; measured at Week 4) were included in this exploratory subanalysis. Assessments of BD symptoms, functioning, and quality of life were completed at monthly visits up until Week 20. Generalised Estimating Equations were used to explore whether IPAQ-SF scores were a moderator of treatment received on outcomes of the study.
RESULTS


Week-4 PA was not related to changes in Montgomery Åsberg Depression Rating Scale scores across the study until Week 20. However, participants who engaged in more PA and who received the combination treatment were more likely to have a reduction in scores on the Bipolar Depression Rating Scale ( P  = 0.03). However, this was not consistent in all domains explored using the IPAQ-SF. Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment.
CONCLUSIONS


This study provides novel evidence of the association between PA and reduction in BD symptoms in a nutraceutical clinical trial. However, further research assessing the potential synergistic effects of PA in BD is required.",2020,"Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment.
","['Participants ( n  = 145) who completed the International Physical Activity Questionnaire-Short Form (IPAQ-SF; measured at Week 4) were included in this exploratory subanalysis', 'Bipolar Depression', 'Individuals with bipolar disorder (BD', 'Participants with bipolar depression']","['N -acetylcysteine alone,  N -acetylcysteine with a combination of nutraceuticals (chosen for the potential to increase mitochondrial activity), or placebo']","['Montgomery Åsberg Depression Rating Scale scores', 'social and occupational functioning', 'quality of life', 'Assessments of BD symptoms, functioning, and quality of life', 'IPAQ-SF scores', 'Bipolar Depression Rating Scale']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0222045'}]",,0.129464,"Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment.
","[{'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Ashton', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Gin S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'Academic Department of Psychiatry, Northern Sydney Local Health District, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Chee H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Richmond, Victoria, Australia.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Centre of Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Richmond, Victoria, Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopwood', 'Affiliation': 'Professorial Psychiatry Unit, Albert Road Clinic, Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': 'Physiotherapy Department, South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719889547']
492,31290996,"A phase 1 and randomized, placebo-controlled phase 2 trial of bevacizumab plus dasatinib in patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872.","BACKGROUND


Src signaling is markedly upregulated in patients with invasive glioblastoma (GBM) after the administration of bevacizumab. The Src family kinase inhibitor dasatinib has been found to effectively block bevacizumab-induced glioma invasion in preclinical models, which led to the hypothesis that combining bevacizumab with dasatinib could increase bevacizumab efficacy in patients with recurrent GBM.
METHODS


After the completion of the phase 1 component, the phase 2 trial (ClinicalTrials.gov identifier NCT00892177) randomized patients with recurrent GBM 2:1 to receive 100 mg of oral dasatinib twice daily (arm A) or placebo (arm B) on days 1 to 14 of each 14-day cycle combined with 10 mg/kg of intravenous bevacizumab on day 1 of each 14-day cycle. The primary endpoint was 6-month progression-free survival (PFS6).
RESULTS


In the 121 evaluable patients, the PFS6 rate was numerically, but not statistically, higher in arm A versus arm B (28.9% [95% CI, 19.5%-40.0%] vs 18.4% [95% CI, 7.7%-34.4%]; P = .22). Similarly, there was no significant difference in the median overall survival noted between the treatment arms (7.3 months and 7.7 months, respectively; P = .93). The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months). The incidence of grade ≥3 toxicity was comparable between treatment arms, with hematologic toxicities occurring more frequently in arm A versus arm B (15.7% vs 7.9%) (adverse events were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). Correlative tissue analysis demonstrated an association between pSRC/LYN signaling in patient tumors and outcome.
CONCLUSIONS


Despite upregulation of Src signaling in patients with GBM, the combination of bevacizumab with dasatinib did not appear to significantly improve the outcomes of patients with recurrent GBM compared with bevacizumab alone.",2019,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","['patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872', 'patients with GBM', 'patients with recurrent GBM', 'patients with invasive glioblastoma (GBM) after the administration of']","['bevacizumab plus dasatinib', '100\xa0mg of oral dasatinib twice daily (arm A) or placebo', 'bevacizumab', 'placebo']","['objective response rate', 'incidence of grade ≥3 toxicity', 'hematologic toxicities', 'median overall survival', 'PFS6 rate', 'bevacizumab efficacy', '6-month progression-free survival (PFS6']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.270075,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","[{'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Twohy', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David Dinh', 'Initials': 'DD', 'LastName': 'Tran', 'Affiliation': 'Oncology Division, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Suriya A', 'Initials': 'SA', 'LastName': 'Jeyapalan', 'Affiliation': 'Department of Neurology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Department of Hematology/Oncology, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Feathers', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Panos Z', 'Initials': 'PZ', 'LastName': 'Anastasiadis', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia Medical Center, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.32340']
493,32027377,Educating Physicians in Family Medicine Residencies About Nonpharmacologic Approaches to Pain: Results of an Online Integrative Course.,"BACKGROUND AND OBJECTIVES


Opioid misuse is at an all-time crisis level, and nationally enhanced resident and clinician education on chronic pain management is in demand. To date, broad-reaching, scalable, integrative pain management educational interventions have not been evaluated for effectiveness on learner knowledge or attitudes toward chronic pain management.
METHODS


An 11-hour integrative pain management (IPM) online course was evaluated for effect on resident and faculty attitudes toward and knowledge about chronic pain. Participants were recruited from family medicine residencies participating in the integrative medicine in residency program. Twenty-two residencies participated, with 11 receiving the course and 11 serving as a control group. Evaluation included pre/post medical knowledge and validated measures of attitude toward pain patients, self-efficacy for nondrug therapies, burnout, and compassion.
RESULTS


Forty-three participants (34.4%) completed the course. The intervention group (n=50), who received the course, improved significantly (P&lt;.05) in medical knowledge, attitude toward pain patients, and self-efficacy to prescribe nondrug therapies while the control group (n=54) showed no improvement. There was no effect on burnout or compassion for either group. The course was positively evaluated, with 83%-94% rating the course content and delivery very high. All participants responded that they would incorporate course information into practice, and almost all thought what they learned in the course would improve patient care (98%).
CONCLUSIONS


Our findings demonstrate the feasibility of an online IPM course as an effective and scalable intervention for residents and primary care providers in response to the current opioid crisis and need for better management of chronic pain. Future directions include testing scalability in formats that lead to improved completion rates, implementation in nonacademic settings, and evaluation of clinical outcomes such as decreased opioid prescribing.",2020,Our findings demonstrate the feasibility of an online IPM course as an effective and scalable intervention for residents and primary care providers in response to the current opioid crisis and need for better management of chronic pain.,"['Participants were recruited from family medicine residencies participating in the integrative medicine in residency program', 'An 11-hour integrative pain management (IPM', 'Twenty-two residencies participated, with 11 receiving the course and 11 serving as a control group', 'Educating Physicians in Family Medicine Residencies About Nonpharmacologic Approaches to Pain']",[],"['pre/post medical knowledge and validated measures of attitude toward pain patients, self-efficacy for nondrug therapies, burnout, and compassion', 'burnout or compassion']","[{'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",22.0,0.0315071,Our findings demonstrate the feasibility of an online IPM course as an effective and scalable intervention for residents and primary care providers in response to the current opioid crisis and need for better management of chronic pain.,"[{'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Chiasson', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}, {'ForeName': 'Audrey J', 'Initials': 'AJ', 'LastName': 'Brooks', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Ricker', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lebensohn', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}, {'ForeName': 'Mei-Kuang', 'Initials': 'MK', 'LastName': 'Chen', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Maizes', 'Affiliation': 'University of Arizona Andrew Weil Center for Integrative Medicine, Tucson, AZ.'}]",Family medicine,['10.22454/FamMed.2020.865003']
494,31910649,OUTSMART HF: A Randomized Controlled Trial of Routine Versus Selective Cardiac Magnetic Resonance for Patients With Nonischemic Heart Failure (IMAGE-HF 1B).,"BACKGROUND


Cardiac magnetic resonance (CMR) is a recommended imaging test for patients with heart failure (HF); however, there is a lack of evidence showing incremental benefit over transthoracic echocardiography. Our primary hypothesis was that routine use of CMR will yield more specific diagnoses in nonischemic HF. Our secondary hypothesis was that routine use of CMR will improve patient outcomes.
METHODS


Patients with nonischemic HF were randomized to routine versus selective CMR. Patients in the routine strategy underwent echocardiography and CMR, whereas those assigned to selective use underwent echocardiography with or without CMR according to the clinical presentation. HF causes was classified from the imaging data as well as by the treating physician at 3 months (primary outcome). Clinical events were collected for 12 months.
RESULTS


A total of 500 patients (344 male) with mean age 59±13 years were randomized. The routine and selective CMR strategies had similar rates of specific HF causes at 3 months clinical follow-up (44% versus 50%, respectively;  P =0.22). At image interpretation, rates of specific HF causes were also not different between routine and selective CMR (34% versus 30%, respectively;  P =0.34). However, 24% of patients in the selective group underwent a nonprotocol CMR. Patients with specific HF causes had more clinical events than those with nonspecific caused on the basis of imaging classification (19% versus 12%, respectively;  P =0.02), but not on clinical assessment (15% versus 14%, respectively;  P =0.49).
CONCLUSIONS


In patients with nonischemic HF, routine CMR does not yield more specific HF causes on clinical assessment. Patients with specific HF causes from imaging had worse outcomes, whereas HF causes defined clinically did not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01281384.",2020,"The Routine and Selective CMR strategies had similar rates of specific HF etiologies at 3 months clinical follow-up, 44% vs. 50% respectively, p=0.22.","['500 patients (344 male), mean age 59±13', 'patients with heart failure (HF', 'Patients with non-ischemic HF', 'Patients with Non-Ischemic Heart Failure']","['Routine versus Selective CMR', 'Cardiac magnetic resonance (CMR', 'OUTSMART HF', 'Routine Versus Selective Cardiac Magnetic Resonance', 'CMR']","['specific HF etiologies', 'clinical events', 'rates of specific HF etiology']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",500.0,0.135895,"The Routine and Selective CMR strategies had similar rates of specific HF etiologies at 3 months clinical follow-up, 44% vs. 50% respectively, p=0.22.","[{'ForeName': 'D Ian', 'Initials': 'DI', 'LastName': 'Paterson', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (D.I.P., J.E.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'School of Epidemiology and Public Health, Department of Medicine and Cardiovascular Research Methods Centre (G.W., L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Erthal', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mielniczuk', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': ""Institut de Cardiologie de Montréal, Université de Montréal, Québec, Canada (E.O'M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Calgary Foothills Medical Centre, University of Calgary, Alberta, Canada (J.W.).'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': ""Keenan Research Centre of the Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Ontario, Canada (K.A.C.).""}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': 'Turku PET Center, Turku University Hospital, University of Turku, Finland (J.K.).'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Radja', 'Affiliation': 'Queen Elizabeth II Hospital, Dalhousie University, Halifax, Nova Scotia, Canada (M.R.).'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Central Hospital, University of Helsinki, Finland (M.L.).'}, {'ForeName': 'Benjamin J W', 'Initials': 'BJW', 'LastName': 'Chow', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Riina', 'Initials': 'R', 'LastName': 'Kandolin', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Epidemiology and Public Health, Department of Medicine and Cardiovascular Research Methods Centre (G.W., L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dick', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dennie', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garrard', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (D.I.P., J.E.).'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Beanlands', 'Affiliation': ''}, {'ForeName': 'Kwan-Leung', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.043964']
495,31544231,Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson's Disease to Inform Clinical Trial Designs.,"A quantitative assessment of Parkinson's disease (PD) progression is critical for optimizing clinical trials design. Disease progression model was developed using pooled data from the Progression Marker Initiative study and the Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease study. Age, gender, concomitant medication, and study arms were predictors of baseline. A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate. The progression rate in subjects with PD who carried LRRK2 mutation was slightly slower (~0.170 points/month) than that in PD subjects without the mutation (~0.222 points/month). For a nonenriched placebo-controlled clinical trial, approximately 70 subjects/arm would be required to detect a drug effect of 50% reduction in the progression rate with 80% probability, whereas 85, 93, and 100 subjects/arm would be required for an enriched clinical trial with 30%, 50%, and 70% subjects with LRRK2 mutations, respectively.",2020,A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate.,[],['placebo'],['progression rate'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",100.0,0.0864223,A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate.,"[{'ForeName': 'Malidi', 'Initials': 'M', 'LastName': 'Ahamadi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Conrado', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Macha', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Sinha', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Nicholas', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ""Parkinson's UK, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dexter', 'Affiliation': ""Parkinson's UK, London, UK.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bani', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Boroojerdi', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Smit', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Weidemann', 'Affiliation': 'Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'GSK UK, Uxbridge, UK.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Romeo', 'Initials': 'R', 'LastName': 'Maciuca', 'Affiliation': 'Denali Therapeutics Inc., San Francisco, California, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lawson', 'Affiliation': ""Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease, Newcastle University, Newcastle upon Tyne, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': ""Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease, Newcastle University, Newcastle upon Tyne, UK.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Marek', 'Affiliation': 'Institute of Neurodegenerative Diseases, New Haven, Connecticut, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Venuto', 'Affiliation': 'University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Stafford', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Mussie', 'Initials': 'M', 'LastName': 'Akalu', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Stephenson', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Romero', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1634']
496,32152488,Blinded randomized crossover trial: Skin-to-skin care vs. sucrose for preterm neonatal pain.,"OBJECTIVE


To compare skin-to-skin care (SSC) and oral sucrose for preterm neonatal pain control.
METHODS


Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible. In group-A, SSC was given 15-min before first heel-stick, and sucrose was given 2-min before second heel-stick. In group-B, the sequence was reversed. Blinded premature infant pain profile (PIPP) score assessment was done at 0, 1, and 5-min of heel-stick by two assessors.
RESULTS


A hundred neonates were enrolled. The inter-rater agreement for the PIPP score was good. The behavior state component was significantly lower in the sucrose group at all assessment points. The mean (SD) difference between 1-min and 0 min was similar [SSC 3.58(3.16) vs. sucrose 4.09(3.82), p = 0.24] between groups. The PIPP score attained baseline values at 5-min in both groups.
CONCLUSION


Albeit sucrose indicated instantaneous action, SSC and sucrose have comparable clinical efficacy for preterm neonatal pain control. Multisensory stimulation with SSC may result in a higher behavioral state component of the PIPP score.",2020,The behavior state component was significantly lower in the sucrose group at all assessment points.,"['preterm neonatal pain control', 'Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible', 'preterm neonatal pain', 'A hundred neonates were enrolled']","['SSC', 'skin-to-skin care (SSC) and oral sucrose', 'Skin-to-skin care vs. sucrose']","['PIPP score', 'PIPP score attained baseline values', 'Blinded premature infant pain profile (PIPP) score assessment', 'behavior state component', 'mean (SD) difference']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0419343', 'cui_str': 'Heel stick (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.154339,The behavior state component was significantly lower in the sucrose group at all assessment points.,"[{'ForeName': 'Somashekhar', 'Initials': 'S', 'LastName': 'Nimbalkar', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Shukla', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India. viveks3985@gmail.com.'}, {'ForeName': 'Vishwa', 'Initials': 'V', 'LastName': 'Chauhan', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Phatak', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Chapla', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Nimbalkar', 'Affiliation': 'Pramukhswami Medical College, Anand, Gujarat, India.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0638-9']
497,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
498,31693077,Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial.,"Importance


Adolescents with atopic dermatitis (AD) have high disease burden negatively affecting quality of life, with limited treatment options. The efficacy and safety of dupilumab, a monoclonal antibody, approved for treatment in adolescent patients with inadequately controlled AD, remain unknown in this patient population.
Objective


To assess the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled AD.
Design, Setting, and Participants


A randomized, double-blind, parallel-group, phase 3 clinical trial was conducted at 45 US and Canadian centers between March 21, 2017, and June 5, 2018. A total of 251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included.
Interventions


Patients were randomized (1:1:1; interactive-response system; stratified by severity and body weight) to 16-week treatment with dupilumab, 200 mg (n = 43; baseline weight <60 kg), or dupilumab, 300 mg (n = 39; baseline weight ≥60 kg), every 2 weeks; dupilumab, 300 mg, every 4 weeks (n = 84); or placebo (n = 85).
Main Outcomes and Measures


Proportion of patients with 75% or more improvement from baseline in Eczema Area and Severity Index (EASI-75) (scores range from 0 to 72, with higher scores indicating greater severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale (scores range from 0 to 4, with higher scores indicating greater severity) at week 16.
Results


A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male). Of 250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6%). A total of 240 patients (95.6%) completed the study. Dupilumab achieved both coprimary end points at week 16. The proportion of patients with EASI-75 improvement from baseline increased (every 2 weeks, 41.5%; every 4 weeks, 38.1%; placebo, 8.2%) with differences vs placebo of 33.2% (95% CI, 21.1%-45.4%) for every 2 weeks and 29.9% (95% CI, 17.9%-41.8%) for every 4 weeks (P < .001). Efficacy of the every-2-week regimen was generally superior to the every-4-week regimen. Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
Conclusions and Relevance


In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile. Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults.
Trial Registration


ClinicalTrials.gov identifier: NCT03054428.",2020,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","['adolescent patients with inadequately controlled AD', 'Adolescents with atopic dermatitis (AD', '250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6', '251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included', 'adolescents with moderate to severe inadequately controlled AD', 'adolescents with moderate to severe AD', 'adolescents and adults', 'A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male', 'Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis', '240 patients (95.6%) completed the study']","['dupilumab, 200 mg (n\u2009=\u200943; baseline weight <60 kg), or dupilumab', 'Placebo', 'placebo', 'dupilumab', 'Dupilumab', 'dupilumab monotherapy']","['AD signs, symptoms, and quality of life', 'injection-site reactions', ""severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale"", 'efficacy and safety', 'Efficacy', 'Efficacy and Safety', 'nonherpetic skin infections', 'proportion of patients with EASI-75 improvement', 'Eczema Area and Severity Index (EASI-75', 'percentage values of conjunctivitis']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0851444', 'cui_str': 'Allergic condition'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037278', 'cui_str': 'Skin Diseases, Infectious'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",251.0,0.507851,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': 'Department of Pediatrics, School of Medicine, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, California.'}, {'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, Atlanta, Georgia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lockshin', 'Affiliation': 'US Dermatology Partners, Rockville, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3336']
499,31350934,The Female Athlete Body project study: 18-month outcomes in eating disorder symptoms and risk factors.,"OBJECTIVE


To evaluate the efficacy of the Female Athlete Body project (FAB) in reducing eating disorder (ED) symptoms and risk factors.
METHOD


This study was a community participatory three-site, two-arm, cluster randomized controlled trial (RCT). Female collegiate athletes (N = 481) were randomly assigned by team to the FAB intervention, a behavioral ED risk factor reduction program, or a waitlist control condition. Primary analyses examined 18-month effects for ED pathology. Secondary analyses examined risk factors and correlates (e.g., thin-ideal internalization, negative mood, Female Athlete Triad knowledge, and body mass index [BMI]).
RESULTS


Linear mixed effects models with team as a cluster level variable and study condition as a between-subjects variable revealed significantly reduced dietary restraint in FAB teams relative to control teams. FAB teams also reported significantly fewer objective and subjective binge episodes than control teams. Finally, FAB teams showed significantly lower thin-ideal internalization and increased BMI at 18-months. No other significant differences were found.
DISCUSSION


This RCT examined the effects of a short intervention on ED pathology and risk factors in female collegiate athletes through 18-month follow-up. This trial is one of only three trials with female athletes that have shown long-term reductions in any ED symptoms or produced positive effects on ED risk factors. The present study is the first to find such effects with athletes using a brief (i.e., 4 hr) intervention at 18-month follow-up. Although small effects were found, the current trial provides valuable lessons about future design and implementation of similar trials with athletes.
TRIAL REGISTRATION


Clinical trials NCT01735994.",2019,FAB teams also reported significantly fewer objective and subjective binge episodes than control teams.,"['female collegiate athletes', 'Female collegiate athletes (N = 481', 'female athletes']","['FAB intervention, a behavioral ED risk factor reduction program, or a waitlist control condition', 'Female Athlete Body project (FAB']","['dietary restraint', 'eating disorder (ED) symptoms and risk factors', 'risk factors and correlates (e.g., thin-ideal internalization, negative mood, Female Athlete Triad knowledge, and body mass index [BMI', 'objective and subjective binge episodes', 'BMI', 'eating disorder symptoms and risk factors', 'ED pathology and risk factors']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1721053', 'cui_str': 'Female Athlete Triad'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",481.0,0.0456857,FAB teams also reported significantly fewer objective and subjective binge episodes than control teams.,"[{'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Tarryn', 'Initials': 'T', 'LastName': 'Pollard', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychiatry, The Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Nicole Y', 'Initials': 'NY', 'LastName': 'Wesley', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Kilpela', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, Trinity University, San Antonio, Texas.'}]",The International journal of eating disorders,['10.1002/eat.23145']
500,31351085,Botulinum toxin and occupational therapy for Writer's cramp.,"BACKGROUND


Writer's cramp (WC) is a form of focal hand dystonia, for which focal botulinum neurotoxin (BoNT) injections are the current best therapy. Past studies have shown that some types of rehabilitative therapy can be useful. We hypothesized that BoNT together with a specific type of occupational therapy would be better than BoNT alone for treating WC patients comparing the effects with a patient-rated subjective scale.
METHODS


Twelve WC patients were randomized to two groups. Six received only BoNT therapy and 6 received BoNT & occupational therapy. The occupational therapy involved specific exercises of finger movements in the direction opposite to the dystonic movements during writing. BoNT was injected by movement disorders neurologists in the affected muscles under electromyography-guidance. The primary outcome was the patient-rated subjective scale at 20 weeks. Secondary exploratory outcomes included the writer's cramp rating scale (WCRS), writer's cramp impairment scale (WCIS), the writer's cramp disability scale (WCDS), handgrip strength and kinetic parameters.
RESULTS


The patient-rated subjective scale scores at 20 weeks were not significantly different between the two groups. Significant objective improvement was noted in the BoNT & occupational therapy group, as noted by the decrease (28%) in WCIS scores.
CONCLUSIONS


Improvement of the primary outcome measure, the patient-rated subjective scale, was not achieved. However, significant improvement was found in the BoNT & occupational therapy group in a secondary measure of impairment. Our hypothesis-driven study results are likely limited by small sample size, and further large-scale studies of occupational therapy methods to improve the efficacy of BoNT seems worthwhile.",2019,"Significant objective improvement was noted in the BoNT & occupational therapy group, as noted by the decrease (28%) in WCIS scores.
","['Twelve WC patients', ""Writer's cramp""]","['Botulinum toxin and occupational therapy', 'BoNT therapy and 6 received BoNT & occupational therapy']","['patient-rated subjective scale scores', 'WCIS scores', 'patient-rated subjective scale', ""writer's cramp rating scale (WCRS), writer's cramp impairment scale (WCIS), the writer's cramp disability scale (WCDS), handgrip strength and kinetic parameters""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp (disorder)""}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp (disorder)""}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.0416024,"Significant objective improvement was noted in the BoNT & occupational therapy group, as noted by the decrease (28%) in WCIS scores.
","[{'ForeName': 'Jung E', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Dongguk University Ilsan Hospital, Goyang, Republic of Korea; Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ejaz A', 'Initials': 'EA', 'LastName': 'Shamim', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Pattamon', 'Initials': 'P', 'LastName': 'Panyakaew', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn Centre of Excellence on Parkinson Disease and Related Disorders, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Toro', 'Affiliation': 'National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sackett', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Karp', 'Affiliation': 'Combined Neuroscience Institutional Review Board, Office of the Clinical Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Codrin', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'Division of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Alter', 'Affiliation': 'Functional and Applied Biomechanics Section, Rehabilitation Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical Neuroscience Program, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Ahmad', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA; Mount Carmel Neurology, Westerville, OH, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Villegas', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sungyoung', 'Initials': 'S', 'LastName': 'Auh', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: hallettm@ninds.nih.gov.'}]",Toxicon : official journal of the International Society on Toxinology,['10.1016/j.toxicon.2019.07.010']
501,31740368,Colchicine's effects on lipoprotein particle concentrations in adults with metabolic syndrome: A secondary analysis of a randomized controlled trial.,"BACKGROUND


Colchicine has received renewed interest for its potential beneficial effects in secondary prevention of cardiovascular disease. This was presumed to be primarily because of its anti-inflammatory effects; however, limited data exist regarding colchicine's impact on other cardiovascular risk factors.
OBJECTIVE


The aim of this study was to examine if colchicine's anti-inflammatory actions would lead to reduced circulating concentrations of oxidized low-density lipoprotein (oxLDL) in metabolically unhealthy individuals. We also examined if colchicine would improve concentrations of other atherogenic lipoprotein subfractions.
METHODS


This is a secondary analysis of a double-blind, randomized, placebo-controlled pilot study in which 40 adults with metabolic syndrome were randomized to colchicine 0.6 mg or placebo twice daily for 3 months. Blood samples were collected in the fasted state. OxLDL was measured using enzyme-linked immunosorbent assay. Nuclear magnetic resonance spectroscopy was used to measure other lipoprotein particle subfraction concentrations.
RESULTS


Compared with placebo, colchicine reduced markers of inflammation, including C-reactive protein, erythrocyte sedimentation rate, and GlycA (P < .01). Concentrations of oxLDL (P = .019) and small LDL (P = .022) appeared significantly increased in the colchicine arm. Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
CONCLUSION


Although colchicine may have benefit in secondary prevention of cardiovascular disease in at-risk individuals, we found no evidence that these effects are because of improvements in circulating atherogenic lipoprotein particle concentrations. Further studies are needed to confirm whether colchicine increases circulating oxLDL and small LDL levels in adults with metabolic syndrome. If true, additional research is warranted to elucidate the mechanisms underlying these associations.",2019,"Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
","['adults with metabolic syndrome', '40 adults with metabolic syndrome', 'metabolically unhealthy individuals']","[""Colchicine's"", 'colchicine 0.6\xa0mg or placebo', 'Colchicine', 'placebo, colchicine', 'oxLDL', 'placebo', 'colchicine']","['lipoprotein particle concentrations', 'circulating atherogenic lipoprotein particle concentrations', 'Blood samples', 'lipoprotein subfractions or lipoprotein particle sizes', 'small LDL', 'markers of inflammation, including C-reactive protein, erythrocyte sedimentation rate, and GlycA (P']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C2718493', 'cui_str': 'Colchicine 0.6 MG [Colcrys]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",40.0,0.656291,"Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA; Johns Hopkins Community Physicians at Howard County General Hospital, Johns Hopkins Medicine, Columbia, MD, USA; Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: ademido1@jhmi.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wolska', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sierra R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sorokin', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.011']
502,31491537,Effect of cysteinyl leukotriene receptor 1 blockade on aeroallergen-induced nasal recruitment of CD49d expressing neutrophils.,,2019,,['aeroallergen-induced nasal recruitment of CD49d expressing neutrophils'],['cysteinyl leukotriene receptor 1 blockade'],[],"[{'cui': 'C0001697', 'cui_str': 'Aeroallergen (attribute)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0753791', 'cui_str': 'cysteinyl leukotriene receptor'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",[],,0.0258341,,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Sammon', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics Nationwide Children's Hospital and The Ohio State University Columbus, Ohio.""}, {'ForeName': 'Syed-Rehan A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics Nationwide Children's Hospital and The Ohio State University Columbus, Ohio; Center for Clinical and Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': ""Division of Clinical Research, Nationwide Children's Hospital Columbus, Ohio.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rohlfing', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics Nationwide Children's Hospital and The Ohio State University Columbus, Ohio; Center for Clinical and Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Santoro', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics Nationwide Children's Hospital and The Ohio State University Columbus, Ohio; Center for Clinical and Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Mitchell H', 'Initials': 'MH', 'LastName': 'Grayson', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics Nationwide Children's Hospital and The Ohio State University Columbus, Ohio; Center for Clinical and Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio. Electronic address: wheeze@allergist.com.""}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2019.08.019']
503,31767595,"Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.","INTRODUCTION


Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.
METHODS AND ANALYSIS


In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.
TRIAL REGISTRATION NUMBER


NCT03226743.",2019,"While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models.","['n=570 patients will be recruited from primary care practices (n=19 practices per group', 'patients with mental disorders in primary care']",['collaborative and stepped care model'],['mental health-related quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",570.0,0.144746,"While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany d.heddaeus@uke.de.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brettschneider', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'von dem Knesebeck', 'Affiliation': 'Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Maehder', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Porzelt', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schulte', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Weigel', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Werner', 'Affiliation': 'Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'Department of General Practice / Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032408']
504,31772092,Effectiveness of the Labour Inspection Authority's regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers.,"INTRODUCTION


There is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health. The Norwegian Labour Inspection Authority (NLIA) uses different tools and strategies to enforce compliance with occupational safety and health (OSH) legislation. The aim of the present study is to evaluate the effects of labour inspections and other regulatory tools employed by the NLIA. The home-care service is one of the fastest growing occupations and a prioritised area for the NLIA, hence the present study will investigate regulatory tools in this sector.
METHODS AND ANALYSIS


The research project has been designed as a longitudinal, cluster-randomised, controlled trial and will be conducted among Norwegian home-care workers. The objective of the research project is to evaluate the effects of the NLIA's regulatory tools (inspection and guidance) on: (1) compliance with OSH legislation and regulation; (2) psychosocial, organisational and mechanical work environment; (3) employee health in terms of musculoskeletal and mental health complaints; and (4) sickness absence. Public home-care services have been randomised to three intervention groups and one control group. Home-care services in the intervention groups will receive one of three intervention activities from the NLIA: (1) inspection from the Labour Inspection Authority; (2) guidance through an online interactive risk-assessment tool; and (3) guidance on psychosocial, organisational and mechanical work environment through workshops. The interventions will be performed at the organisational level (home-care service), and the effects of the interventions on the working environment and health complaints will be measured at the individual level (home-care employees).
ETHICS AND DISSEMINATION


This project has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East) (2018/2003/REK sør-øst C), the Norwegian Center for Research Data (566128), and will be conducted in accordance with the World Medical Association Declaration of Helsinki. The results will be reported in international peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03855163.",2019,"There is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health.","['Norwegian home-care workers', 'Public home-care services']","['three intervention activities from the NLIA: (1) inspection from the Labour Inspection Authority; (2) guidance through an online interactive risk-assessment tool; and (3) guidance on psychosocial, organisational and mechanical work environment through workshops']",[],"[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]",[],,0.0367179,"There is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health.","[{'ForeName': 'Anne-Marthe R', 'Initials': 'AR', 'LastName': 'Indregard', 'Affiliation': 'Department of Occupational Health Surveillance, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Knardahl', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Jan Shahid', 'Initials': 'JS', 'LastName': 'Emberland', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Skare', 'Affiliation': 'Department of Occupational Medicine and Epidemiology, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Håkon A', 'Initials': 'HA', 'LastName': 'Johannessen', 'Affiliation': 'Department of Occupational Health Surveillance, National Institute of Occupational Health, Oslo, Norway hajo@stami.no.'}]",BMJ open,['10.1136/bmjopen-2019-031226']
505,31780589,Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).,"INTRODUCTION


Antipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
METHODS AND ANALYSIS


This is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022.
ETHICS AND DISSEMINATION


Ethical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public.
TRIAL REGISTRATION NUMBER


ISRCTN90298520. EudraCT: 2016-000709-36. Pre-results.",2019,"Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
","['people with schizophrenia and related disorders', 'people with schizophrenia and related disorders who have had more than one episode', '134 evaluable participants']","['EudraCT', 'Antipsychotic medication', 'gradual antipsychotic reduction and discontinuation']","['social functioning, measured by the Social Functioning Scale', 'severe relapse', 'all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures', 'severe relapse (admission to hospital', 'risk of relapse']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale (assessment scale)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",402.0,0.166369,"Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moncrieff', 'Affiliation': 'Division of Psychiatry, University College London and North East London NHS Foundation Trust, London, UK j.moncrieff@ucl.ac.uk.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute for Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Thomas R E', 'Initials': 'TRE', 'LastName': 'Barnes', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Lyn J', 'Initials': 'LJ', 'LastName': 'Kent', 'Affiliation': 'Independent consultant, Brentwood, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Independent consultant, Brighton, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Darton', 'Affiliation': 'Independent consultant, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Nadia E', 'Initials': 'NE', 'LastName': 'Crellin', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Cooper', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Louise', 'Initials': '', 'LastName': 'Marston', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030912']
506,30937510,A randomized-controlled trial of treatment for self-stigma among persons diagnosed with schizophrenia-spectrum disorders.,"PURPOSE


A substantial body of research indicates that self-stigma is associated with poorer outcomes related to recovery among people with severe mental illnesses. Narrative Enhancement and Cognitive Therapy (NECT) is a structured, group-based approach which targets the effects of self-stigma. A randomized-controlled trial was conducted to examine the efficacy of NECT.
METHODS


One hundred and seventy persons, recruited from both outpatient and comprehensive treatment settings, meeting criteria for schizophrenia-spectrum disorders and moderate-to-elevated self-stigma, were randomly assigned to NECT or supportive group therapy and assessed at four time points over the course of nearly a year. Participants completed measures of self-stigma, hope, self-esteem, functioning, psychiatric symptoms, coping with symptoms, and narrative insight.
RESULTS


Analyses indicated that NECT participants in outpatient sites improved significantly more over time in self-stigma compared to supportive group therapy participants in outpatient sites, while NECT participants in comprehensive (including day treatment and psychiatric rehabilitation program) sites improved significantly more in hopelessness and narrative insight than other participants. NECT participants as a group showed decreases in the social withdrawal component of self-stigma, decreased in their use of avoidant coping strategies, and were more engaged in treatment than supportive group therapy participants. There was no evidence for effects of NECT on social functioning or psychiatric symptoms.
CONCLUSIONS


Findings suggest that NECT primarily impacts self-stigma and related outcomes, and that the degree of its effects is partially dependent on the treatment context in which it is offered.",2019,"RESULTS


Analyses indicated that NECT participants in outpatient sites improved significantly more over time in self-stigma compared to supportive group therapy participants in outpatient sites, while NECT participants in comprehensive (including day treatment and psychiatric rehabilitation program) sites improved significantly more in hopelessness and narrative insight than other participants.","['people with severe mental illnesses', 'persons diagnosed with schizophrenia-spectrum disorders', 'One hundred and seventy persons, recruited from both outpatient and comprehensive treatment settings, meeting criteria for schizophrenia-spectrum disorders and moderate-to-elevated self-stigma']","['Narrative Enhancement and Cognitive Therapy (NECT', 'NECT or supportive group therapy', 'NECT']","['social withdrawal component of self-stigma', 'time in self-stigma', 'social functioning or psychiatric symptoms', 'self-stigma, hope, self-esteem, functioning, psychiatric symptoms, coping with symptoms, and narrative insight', 'hopelessness and narrative insight']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0424095', 'cui_str': 'Social withdrawal (finding)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}]",170.0,0.0564041,"RESULTS


Analyses indicated that NECT participants in outpatient sites improved significantly more over time in self-stigma compared to supportive group therapy participants in outpatient sites, while NECT participants in comprehensive (including day treatment and psychiatric rehabilitation program) sites improved significantly more in hopelessness and narrative insight than other participants.","[{'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Yanos', 'Affiliation': 'John Jay College of Criminal Justice, City University of New York, New York, USA. pyanos@jjay.cuny.edu.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lysaker', 'Affiliation': 'Roudebush VA Medical Center, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'Rutgers University, Piscataway, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Vayshenker', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gonzales', 'Affiliation': 'Gordon F. Derner School of Psychology, Adelphi University, New York, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'West', 'Affiliation': 'Harvard Medical School, Boston, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roe', 'Affiliation': 'University of Haifa, Haifa, Israel.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-019-01702-0']
507,30730774,The Parent-Child Relationship and Posttreatment Child Outcomes Across Two Treatments for Oppositional Defiant Disorder.,"This study examined the degree to which the parent-child relationship uniquely predicted clinical outcomes in externalizing problems and adaptive skills in children meeting diagnostic criteria for oppositional defiant disorder and whether facets of this relationship moderated the effects of two unique psychosocial treatments. We recruited 134 children and their parents (38.06% female;  M  age = 9.52 years, range = 7-14; 83.58% White). Families were randomly assigned to 1 of 2 treatments: Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS). We formed principal components from pretreatment reports and behaviors of the parent-child relationship to predict within- and between-family outcomes in children's externalizing problems and adaptive skills. Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness). Parental monitoring predicted fewer externalizing problems, whereas family permissiveness predicted more externalizing problems. Parental warmth predicted greatest improvements in children's adaptive skills among families receiving PMT. Family hostility predicted more externalizing problems and poorer adaptive skills for children; however, families receiving CPS were buffered from the negative effect of family hostility on adaptive skills. The parent-child relationship can uniquely inform posttreatment outcomes following treatment for oppositional defiant disorder. Certain treatment approaches may better fit unique relationships that emphasize warmth and/or hostility, allowing clinicians to anticipate and tailor treatments to families.",2020,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[""children's externalizing problems and adaptive skills"", 'children meeting diagnostic criteria for oppositional defiant disorder', '134 children and their parents (38.06% female; M age\xa0']",['Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS'],"['externalizing problems and poorer adaptive skills', ""children's adaptive skills"", 'externalizing problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517748', 'cui_str': 'Thirty-eight point zero six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",134.0,0.0478645,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Booker', 'Affiliation': 'Department of Psychological Sciences, University of Missouri.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Department of Psychology, University of Alabama.'}, {'ForeName': 'Ross W', 'Initials': 'RW', 'LastName': 'Greene', 'Affiliation': 'Child Study Center, Virginia Tech.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Tech.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1555761']
508,31147243,Social Support and Depression Related to Older Adults' Hypertension Control in Rural China.,"OBJECTIVE


This study aimed to investigate association between social support and hypertension (HTN) control in rural China older adults, and to what extent depression mediates this relationship. The authors hypothesized that depression severity mediated the relationship between social support and HTN control.
METHODS


Data for the analyses were obtained from baseline data from a randomized controlled clinical trial of a collaborative depression care management intervention conducted in rural villages of China, with older adults with comorbid depression and HTN. Data included baseline assessments of 2,351 subjects aged 60 years and older, whose blood pressure and depression severity were measured using a calibrated manual sphygmomanometer and the 17-item Hamilton Depression Rating Scale (HDRS-17), respectively. Social support was measured using the 20-item Medical Outcomes Study-Social Support Survey.
RESULTS


Uncontrolled HTN was associated with older age (t[df = 2349] = 3.16; p < 0.01), higher HDRS-17 score (t[df = 1488] = 5.89; p < 0.001), and lower social support (t[df = 2349] = 5.37; p < 0.001). A significant indirect effect of social support via depression severity in relation to HTN control (a × b = -0.04[0.01]), bootstrap p = 0.0015, and 95% confidence interval (-0.07, -0.02), accounting for 11% of the effect of social support on HTN control.
CONCLUSION


These findings imply that social support impacts HTN control directly and indirectly through depression. Intervention approaches such as primary care-based collaborative care models should address social support to achieve greater outcomes for depression and HTN management.",2019,"RESULTS


Uncontrolled HTN was associated with older age (t[df = 2349] = 3.16; p < 0.01), higher HDRS-17 score (t[df = 1488] = 5.89; p < 0.001), and lower social support (t[df = 2349] = 5.37; p < 0.001).","[""Older Adults' Hypertension Control in Rural China"", '2,351 subjects aged 60 years and older', 'rural China older adults', 'rural villages of China, with older adults with comorbid depression and HTN']","['social support and hypertension (HTN) control', 'collaborative depression care management intervention']","['higher HDRS-17 score', 'blood pressure and depression severity', '17-item Hamilton Depression Rating Scale (HDRS-17']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0037438'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4708576', 'cui_str': 'Depression care management'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",2351.0,0.0247999,"RESULTS


Uncontrolled HTN was associated with older age (t[df = 2349] = 3.16; p < 0.01), higher HDRS-17 score (t[df = 1488] = 5.89; p < 0.001), and lower social support (t[df = 2349] = 5.37; p < 0.001).","[{'ForeName': 'Tingfei', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology and Behavior Sciences, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': 'Department of Psychology and Behavior Sciences, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Behavior Sciences, Zhejiang University, Hangzhou, Zhejiang, China. Electronic address: chenshulin@zju.edu.cn.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.04.014']
509,30270167,Health-Related Quality of Life in Children and Young Adults with Marfan Syndrome.,"OBJECTIVE


To assess health-related quality of life (HRQOL) in a large multicenter cohort of children and young adults with Marfan syndrome participating in the Pediatric Heart Network Marfan Trial.
STUDY DESIGN


The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales were administered to 321 subjects with Marfan syndrome (5-25 years). PedsQL scores were compared with healthy population norms. The impact of treatment arm (atenolol vs losartan), severity of clinical features, and number of patient-reported symptoms on HRQOL was assessed by general linear models.
RESULTS


Mean PedsQL scores in children (5-18 years) with Marfan syndrome were lower than healthy population norms for physical (P ≤ .003) and psychosocial (P < .001) domains; mean psychosocial scores for adults (19-25 years) were greater than healthy norms (P < .001). HRQOL across multiple domains correlated inversely with frequency of patient-reported symptoms (r = 0.30-0.38, P < .0001). Those <18 years of age with neurodevelopmental disorders (mainly learning disability, attention-deficit/hyperactivity disorder) had lower mean PedsQL scores (5.5-7.4 lower, P < .04). A multivariable model found age, sex, patient-reported symptoms, and neurodevelopmental disorder to be independent predictors of HRQOL. There were no differences in HRQOL scores by treatment arm, aortic root z score, number of skeletal features, or presence of ectopia lentis.
CONCLUSIONS


Children and adolescents with Marfan syndrome were at high risk for impaired HRQOL. Patient-reported symptoms and neurodevelopmental disorder, but not treatment arm or severity of Marfan syndrome-related physical findings, were associated with lower HRQOL.",2019,"There were no differences in HRQOL scores by treatment arm, aortic root z score, number of skeletal features, or presence of ectopia lentis.
","['321 subjects with Marfan syndrome (5-25 years', 'Children and Young Adults with Marfan Syndrome', 'Children and adolescents with Marfan syndrome', 'children and young adults with Marfan syndrome participating in the Pediatric Heart Network Marfan Trial']",['atenolol vs losartan'],"['mean psychosocial scores', 'mean PedsQL scores', 'health-related quality of life (HRQOL', 'severity of clinical features, and number of patient-reported symptoms on HRQOL', 'PedsQL scores', 'Health-Related Quality of Life', 'aortic root z score, number of skeletal features, or presence of ectopia lentis', 'HRQOL scores', 'Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales', 'Mean PedsQL scores']","[{'cui': 'C0024796', 'cui_str': 'Marfan Syndrome, Type I'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018787', 'cui_str': 'Heart'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0013581', 'cui_str': 'Ectopia Lentis'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0222045'}]",321.0,0.145993,"There were no differences in HRQOL scores by treatment arm, aortic root z score, number of skeletal features, or presence of ectopia lentis.
","[{'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Handisides', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes Inc., Watertown, MA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Uzark', 'Affiliation': ""C. S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes Inc., Watertown, MA.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Teresa W', 'Initials': 'TW', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Bradley', 'Affiliation': 'The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Georgeann Keh-Teng', 'Initials': 'GK', 'LastName': 'Groh', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY.""}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bergen', 'Initials': 'B', 'LastName': 'Lindauer', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT.""}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Liou', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Meghan K Mac', 'Initials': 'MKM', 'LastName': 'Neal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN.""}, {'ForeName': 'Tonia', 'Initials': 'T', 'LastName': 'Morrison', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Mussatto', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Mary Ella M', 'Initials': 'MEM', 'LastName': 'Pierpont', 'Affiliation': ""Children's Hospital and Clinic of Minnesota, St. Paul, MN.""}, {'ForeName': 'Reed E', 'Initials': 'RE', 'LastName': 'Pyeritz', 'Affiliation': 'The Perlman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Radojewski', 'Affiliation': 'The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Roman', 'Affiliation': 'Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA. Electronic address: ron.lacro@cardio.chboston.org.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2018.08.061']
510,30267385,Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential.,"BACKGROUND


Multifocal visual evoked potential (MF-VEP) assesses a wider visual field than full-field VEP (FF-VEP) and potentially offers a more precise analysis of optic nerve injury and repair following optic neuritis. MF-VEP may offer advantages over FF-VEP as an endpoint in clinical trials of remyelinating therapies.
OBJECTIVE


MF-VEP testing was used to study changes in visual pathways in 48% of RENEW [phase II, opicinumab (anti-LINGO-1; BIIB033) vs. placebo after first acute unilateral optic neuritis] participants.
METHODS


This exploratory MF-VEP RENEW substudy compared mean outcomes at weeks 24 and 32 among participants in the intent-to-treat (ITT; n = 39; 72% female; mean age: 32.3 years) and per-protocol (PP; n = 31; 71% female; mean age: 32.2 years) populations in affected and fellow eye latency from fellow eye baseline latency and affected and fellow eye amplitude from their own baselines. Treatment differences were evaluated using analysis of covariance (week 24) and a mixed-effect model of repeated measures (week 32). Last observation carried forward was used to impute missing data at week 24.
RESULTS


A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32. Both treatment groups in the ITT population experienced partial recovery of amplitude in the affected eye at week 32. Notably, the mean change in fellow eye amplitude at weeks 24 and 32 was - 17.57 and - 31.41 nanovolts (nV) in placebo but only - 0.59 and 1.93 nV in the opicinumab group [differences at weeks 24 and 32: 16.98 nV (p = 0.050) and 33.33 nV (p < 0.01), respectively].
CONCLUSION


Results from this substudy showed advantages of MF-VEP over FF-VEP in multicenter studies of central nervous system reparative therapies and provide novel evidence that fellow eye visual pathway amplitude loss occurs after optic neuritis but can potentially be prevented by opicinumab treatment.
REGISTRATION


ClinicalTrials.gov identifier NCT01721161.",2018,A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32.,"['mean outcomes at weeks 24 and 32 among participants in the intent-to-treat (ITT; n\u2009=\u200939; 72% female; mean age', 'acute unilateral optic neuritis] participants', '32.3\xa0years) and per-protocol (PP; n\u2009=\u200931; 71% female; mean age: 32.2\xa0years) populations in affected and fellow eye latency from fellow eye baseline\xa0latency and affected and fellow eye amplitude\xa0from their own baselines']","['placebo', 'Opicinumab']","['eye MF-VEP latency', 'partial recovery of amplitude', 'mean change in fellow eye amplitude']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550038', 'cui_str': 'opicinumab'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.131963,A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Klistorner', 'Affiliation': 'Department of Ophthalmology, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leocani', 'Affiliation': 'Neurological Department and Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), University Hospital-IRCCS San Raffaele, Milan, Italy.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Albrecht', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'Department of Neuroscience, Central Clinical School, Monash University Alfred Campus, Melbourne, VIC, Australia.'}, {'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'MS Center Dresden, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Focke', 'Initials': 'F', 'LastName': 'Ziemssen', 'Affiliation': 'Center for Ophthalmology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Neurology, Rigshospitalet Glostrup and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': 'Biogen, Cambridge, MA, USA. cadavid.diego@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CNS drugs,['10.1007/s40263-018-0575-8']
511,31960624,"A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.","Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo-controlled, single-ascending-dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Participants were assigned to 1 of 3 tezepelumab dose cohorts (35, 105, or 280 mg; n = 8 per cohort) and randomized (6:2) to receive a single subcutaneous dose of tezepelumab or placebo, with a follow-up period of 84 to 112 days. The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups. Tezepelumab was absorbed slowly, reaching a maximum serum concentration (mean, 5.2-39.7 µg/mL) after 7 to 10 days. Area under the concentration-time curve (mean, 207.2-1612.0 µg · day /mL) increased in an approximate dose-proportional manner. Tezepelumab had a long terminal serum half-life (mean, 23.9-26.3 days) and a small apparent distribution volume, suggesting limited distribution into peripheral tissues. No participants developed anti-tezepelumab antibodies. Single-dose, subcutaneous administration of tezepelumab 35 to 280 mg resulted in an acceptable safety profile with linear pharmacokinetics in healthy Japanese men. No clear differences in tezepelumab safety and pharmacokinetics between Japanese and non-Japanese populations were identified.",2020,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"['healthy Japanese men', 'Healthy Japanese Men']","['Placebo', 'Tezepelumab', 'tezepelumab', 'tezepelumab or placebo', 'placebo', 'Subcutaneous Tezepelumab', 'subcutaneous tezepelumab']","['overall incidences and severities of treatment-emergent adverse events', 'anti-tezepelumab antibodies', 'tezepelumab safety and pharmacokinetics', 'Safety, Tolerability, Pharmacokinetics, and Immunogenicity', 'maximum serum concentration', 'concentration-time curve', 'safety, tolerability, pharmacokinetics, and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.196404,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Matsuki', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacology, Division of Clinical Pharmacology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Quantitative Clinical Pharmacology, AstraZeneca, Gaithersburg, Maryland, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.775']
512,31139998,Self-directed training with e-learning using the first-person perspective for laparoscopic suturing and knot tying: a randomised controlled trial : Learning from the surgeon's real perspective.,"BACKGROUND


Laparoscopic suturing and knot tying is essential for advanced laparoscopic procedures and requires training outside of the operating room. However, personal instruction by experienced surgeons is limitedly available. To address this, the concept of combining e-learning with practical training has become of interest. This study aims to investigate the influence of the first-person perspective in instructional videos, as well as the feasibility of a completely self-directed training curriculum for laparoscopic suturing and knot tying.
MATERIALS AND METHODS


Ninety-one laparoscopically naïve medical students were randomised into two groups training with e-learning videos in either the first-person perspective (combining endoscopic view and view of hands/instruments/forearm motion) or the endoscopic view only. Both groups trained laparoscopic suturing and knot tying in teams of two until reaching predefined proficiency levels. Blinded, trained raters regularly assessed the participants' performance by using validated checklists. After training, participants filled out questionnaires regarding training experience and personal characteristics.
RESULTS


Average training time to reach proficiency did not differ between groups [first-person perspective (min): 112 ± 44; endoscopic view only (min): 109 ± 47; p = 0.746]. However, participants from both groups perceived the first-person perspective as useful for learning new laparoscopic skills. Both groups showed similar baseline performances and improved significantly after training [Objective Structured Assessment of Technical Skills (OSATS) (max. 37 points): first-person perspective: 30.3 ± 2.3; endoscopic view only: 30.8 ± 2.3]. All participants managed to reach proficiency, needing 8-43 attempts without differences between groups. Visuospatial abilities (mental rotation) seemed to enhance the learning curve.
CONCLUSION


Modifying instructional videos to the first-person perspective did not translate into a better performance in this setting but was welcomed by participants. Completely self-directed training with the use of e-learning can be a feasible training approach to achieve technical proficiency in laparoscopic suturing and knot tying in a training setting.",2020,Both groups showed similar baseline performances and improved significantly after training [Objective Structured Assessment of Technical Skills (OSATS) (max.,"['37 points', 'Ninety-one laparoscopically naïve', 'medical students']","['Self-directed training with e-learning using the first-person perspective for laparoscopic suturing and knot tying', 'training with e-learning videos in either the first-person perspective (combining endoscopic view and view of hands/instruments/forearm motion) or the endoscopic view only', 'Laparoscopic suturing and knot tying', 'laparoscopic suturing and knot tying']","['Visuospatial abilities (mental rotation', 'Technical Skills (OSATS) (max']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",91.0,0.0264194,Both groups showed similar baseline performances and improved significantly after training [Objective Structured Assessment of Technical Skills (OSATS) (max.,"[{'ForeName': 'Mona W', 'Initials': 'MW', 'LastName': 'Schmidt', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Karl-Friedrich', 'Initials': 'KF', 'LastName': 'Kowalewski', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Trent', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Beat P', 'Initials': 'BP', 'LastName': 'Müller-Stich', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Nickel', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. felix.nickel@med.uni-heidelberg.de.'}]",Surgical endoscopy,['10.1007/s00464-019-06842-7']
513,31831473,Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA 1c  in Andalusia (Spain): PLATEDIAN Study.,"OBJECTIVE


To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes.
RESEARCH DESIGN AND METHODS


PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA 1c  <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) ( n  = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) ( n  = 163). The primary efficacy end point was the mean change of HbA 1c  levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction.
RESULTS


At month 6, the mean change in HbA 1c  levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC ( P  = 0.4941). The number of patients who achieved HbA 1c  <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months ( P  < 0.05).
CONCLUSIONS


The use of telemedicine in patients with type 1 diabetes with HbA 1c  <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.",2020,Significant differences were not found regarding safety end points at 6 months.,"['Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA 1c  in Andalusia (Spain', 'Type 1 Diabetes Mellitus Andalusian Patients', 'A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three', 'patients with type 1 diabetes', 'patients with type 1 diabetes with HbA 1c  <8% (<64 mmol/mol', 'patients with type 1 diabetes with suboptimal metabolic control (HbA 1c  <8% [<64 mmol/mol]), treated with multiple daily injections']","['Telemedicine Care', 'face-to-face visits (control cohort [CC]) ( n  = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC', 'telemedicine visit', 'telemedicine']","['mean change in HbA 1c  levels', 'fear of hypoglycemia', 'mean change of HbA 1c  levels', 'Changes in HRQoL', ""mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",388.0,0.0339528,Significant differences were not found regarding safety end points at 6 months.,"[{'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Ruiz de Adana', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Alhambra-Expósito', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Muñoz-Garach', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Gonzalez-Molero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Colomo', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain nataliacolomo@gmail.com.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Torres-Barea', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario de Jerez, Jerez, Cádiz, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Aguilar-Diosdado', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Florentino', 'Initials': 'F', 'LastName': 'Carral', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Puerto Real, Puerto Real, Cádiz, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Serrano', 'Affiliation': 'Endocrinology and Nutrition Department, Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Martínez-Brocca', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Medical Department, Sanofi Spain, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Palomares', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0739']
514,31984762,Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial.,"BACKGROUND/AIMS


In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention.
METHODS


Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point).
RESULTS


At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93-1.10,  p  = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98-1.27,  p  = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98-1.56,  p  = .08).
CONCLUSION


Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.",2020,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","['305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants', 'participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125']",['telephone calls'],"['visit completion, excluding deaths', 'completion rates', 'completion rate']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",152.0,0.554304,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leanne T', 'Initials': 'LT', 'LastName': 'Labriola', 'Affiliation': 'Department of Ophthalmology, Carle Foundation Hospital, College of Medicine, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Oliver', 'Affiliation': 'Southeastern Retina Associates, Knoxville, TN, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519894229']
515,31974070,Changes in causes of death and influence of therapeutic improvement over time in patients with heart failure and reduced ejection fraction.,"INTRODUCTION AND OBJECTIVES


In patients with heart failure and reduced ejection fraction (HFrEF), several therapies have been proven to reduce mortality in clinical trials. However, there are few data on the effect of the use of evidence-based therapies on causes of death in clinical practice.
METHODS


This study included 2351 outpatients with HFrEF (< 40%) from 2 multicenter prospective registries: MUSIC (n=641, period: 2003-2004) and REDINSCOR I (n=1710, period: 2007-2011). Variables were recorded at inclusion and all patients were followed-up for 4 years. Causes of death were validated by an independent committee.
RESULTS


Patients in REDINSCOR I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04). In these patients, sudden cardiac death was less frequent than in those in MUSIC (6.8% vs 11.4%; P <.001). After propensity score matching, we obtained 2 comparable populations differing only in treatments (575 vs 575 patients). In patients in REDINSCOR I, we found a lower risk of total mortality (HR, 0.70; 95%CI, 0.57-0.87; P=.001) and sudden cardiac death (sHR, 0.46; 95%CI, 0.30-0.70; P <.001), and a trend toward lower mortality due to end-stage HF (sHR, 0.73; 95%CI, 0.53-1.01; P=.059), without differences in other causes of death (sHR, 1.17; 95%CI, 0.78-1.75; P=.445), regardless of functional class.
CONCLUSIONS


In ambulatory patients with HFrEF, implementation of evidence-based therapies was associated with a lower risk of death, mainly due to a significant reduction in sudden cardiac death.",2020,"I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04).","['2351 outpatients with HFrEF (< 40%) from 2 multicenter prospective registries: MUSIC (n=641, period: 2003-2004) and REDINSCOR I (n=1710, period: 2007-2011', 'patients with heart failure and reduced ejection fraction (HFrEF', 'Patients in REDINSCOR', 'patients with heart failure and reduced ejection fraction']",['beta-blockers'],"['mineralocorticoid antagonists', 'lower risk of total mortality', 'implantable cardioverter-defibrillators', 'sudden cardiac death']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}]",2351.0,0.405092,"I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fernández-Vázquez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Universidad de Murcia, IMIB-Arrixaca, El Palmar, Murcia, Spain.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Ferrero-Gregori', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-García', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Gómez-Otero', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, IDIS, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Delgado Jiménez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario 12 de Octubre, Facultad de Medicina UCM, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Worner Diz', 'Affiliation': 'Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'García-Pavía', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain; Facultad de Medicina, Universidad Francisco de Vitoria (UFV), Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'Servicio de Cardiología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, IDIS, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cinca', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual Figal', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Universidad de Murcia, IMIB-Arrixaca, El Palmar, Murcia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: dpascual@um.es.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.09.030']
516,31961446,A trial-based cost-effectiveness analysis of topical 5-fluorouracil vs. imiquimod vs. ingenol mebutate vs. methyl aminolaevulinate conventional photodynamic therapy for the treatment of actinic keratosis in the head and neck area performed in the Netherlands.,"BACKGROUND


Actinic keratosis (AK) is a common premalignant skin condition that might have the ability to progress into squamous cell carcinoma. Due to the high incidence of AK, treatment of this disease significantly impacts healthcare spending.
OBJECTIVES


To determine which commonly prescribed field-directed treatment is the most cost-effective, when comparing 5-fluorouracil (5-FU) 5%, imiquimod (IMQ) 5%, ingenol mebutate (IM) 0·015% and methyl aminolaevulinate photodynamic therapy (MAL-PDT) for AK in the head and neck region.
METHODS


We performed an economic evaluation from a healthcare perspective. Data were collected alongside a single-blinded, prospective, multicentre randomized controlled trial with 624 participants in the Netherlands. The outcome measure was expressed as the incremental cost-effectiveness ratio, which is the incremental costs per additional patient with ≥ 75% lesion reduction compared with baseline. This trial was registered at ClinicalTrials.gov, number NCT02281682.
RESULTS


The trial showed that 5-FU was the most effective field treatment for AK in the head and neck region. Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433) than the €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively. The results showed that 5-FU was a dominant cost-effective treatment (more effective and less expensive) compared with the other treatments, 12 months post-treatment.
CONCLUSIONS


Based on these results, we consider 5-FU 5% cream as the first-choice treatment option for multiple AKs in the head and neck area. What's already known about this topic? Due to the increasing incidence of actinic keratosis (AK), the recommended treatment results in a considerable socioeconomic burden for (dermatological) healthcare. Although cost-effectiveness modelling studies have been performed in which different treatments for AK were compared, a prospective clinical trial comparing four frequently prescribed treatments on effectiveness and resource consumption within a time horizon of 12 months has never been conducted. What does this study add? This is the first study examining the cost-effectiveness of 5-fluorouracil 5% cream, imiquimod 5% cream, ingenol mebutate 0·015% gel and methyl aminolaevulinate photodynamic therapy, with data collected in a randomized controlled trial over a time horizon of 12 months. We found that 5-fluorouracil was a dominant cost-effective treatment (more effective and less costly), based on data from the Netherlands. Linked Comment: Steeb et al. Br J Dermatol 2020; 183:612.",2020,"Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433), compared to €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively.","['actinic keratosis in the head and neck area performed in the Netherlands', '624 participants in the Netherlands', 'Actinic keratosis (AK']","['5-FU', 'topical 5-fluorouracil vs imiquimod vs ingenol mebutate vs methylaminolevulinate conventional photodynamic therapy', '5-FU cream', '5-fluorouracil (5-FU), 5% imiquimod (IMQ), 0.015% ingenol mebutate (IM), and methylaminolevulinate photodynamic therapy (MAL-PDT']","['incremental cost-effectiveness ratio (ICER), which is the incremental costs per additional patient with ≥75% lesion reduction', 'total mean costs for 5-FU']","[{'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C4517396', 'cui_str': 'Zero point zero one five'}, {'cui': 'C0044588', 'cui_str': 'PDT'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]",624.0,0.0451631,"Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433), compared to €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively.","[{'ForeName': 'M H E', 'Initials': 'MHE', 'LastName': 'Jansen', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'J P H M', 'Initials': 'JPHM', 'LastName': 'Kessels', 'Affiliation': 'Department of Dermatology, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Merks', 'Affiliation': 'Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'N W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'B A B', 'Initials': 'BAB', 'LastName': 'Essers', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.18884']
517,31139989,"A randomized Comparison of laparoscopic LEns defogging using Anti-fog solution, waRm saline, and chlorhexidine solution (CLEAR).","OBJECTIVE


Current literature demonstrates a lack of comparative in vivo studies regarding laparoscopic lens fogging (LLF). This randomized trial aimed to compare 3 popular methods of minimizing or reducing LLF in laparoscopic surgery by heating the lens using warm saline, applying anti-fog solution to the lens, and rubbing the lens with chlorhexidine solution.
METHODS


Ninety-six participants underwent randomization to be allocated in control (n = 24), warm saline (n = 24), anti-fog solution (n = 24), and chlorhexidine groups (n = 24). The primary outcome measure was the severity of LLF during the first 3 min after laparoscope insertion into the abdominal cavity. The severity of LLF was rated on a 10-point visual clarity scale ranging from 0 (clearest) to 10 (foggiest). The secondary outcome measures were (1) the severity of LLF during the remaining operative time other than the first 3 min, (2) the number of lens cleansings, and (3) the total time required to clean the lens.
RESULTS


Lens fogging during the first 3 min and remaining operative time other than the first 3 min was significantly decreased in the warm saline group compared to that in the other 3 groups (all, P < 0.001). In post hoc analysis, the anti-fog solution group was significantly foggier than the warm saline group, but clearer than the chlorhexidine and control groups. The number of lens cleansings and total time required to clean the lens were significantly lower in the warm saline and anti-fog solution groups than in the chlorhexidine and control groups (all, P < 0.05).
CONCLUSION


The use of warm saline leads to significantly fewer fogging events than the use of anti-fog solution or chlorhexidine solution, resulting in an improved continuity of surgery.",2020,"The number of lens cleansings and total time required to clean the lens were significantly lower in the warm saline and anti-fog solution groups than in the chlorhexidine and control groups (all, P < 0.05).
",['Ninety-six participants'],"['laparoscopic lens fogging (LLF', 'laparoscopic LEns defogging using Anti-fog solution, waRm saline, and chlorhexidine solution (CLEAR', 'warm saline (n\u2009=\u200924), anti-fog solution', 'chlorhexidine solution', 'chlorhexidine']","['severity of LLF during the remaining operative time other than the first 3\xa0min, (2) the number of lens cleansings, and (3) the total time required to clean the lens', 'severity of LLF during the first 3\xa0min after laparoscope insertion into the abdominal cavity', '10-point visual clarity scale', 'remaining operative time', 'number of lens cleansings and total time required to clean the lens', 'severity of LLF']","[{'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0023036', 'cui_str': 'Celioscopes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0230168', 'cui_str': 'Cavitas abdominis'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0222045'}]",96.0,0.081929,"The number of lens cleansings and total time required to clean the lens were significantly lower in the warm saline and anti-fog solution groups than in the chlorhexidine and control groups (all, P < 0.05).
","[{'ForeName': 'Taejong', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics & Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea. taejong.song@gmail.com.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}]",Surgical endoscopy,['10.1007/s00464-019-06852-5']
518,31953630,Neural substrate of a cognitive intervention program using Go game: a positron emission tomography study.,"BACKGROUND


Influence of cognitive intervention programs on brain activity has not been enough explored.
AIMS


The aims of the present study were to clarify changes in brain activity from a cognitive intervention program utilizing the board game ""Go"" and to examine the relationship between brain activity and the acquisition of Go skills.
METHODS


Eighteen community-dwelling older adults were randomly assigned either to an intervention group (IG), in which members attended 12 Go lessons either in groups or individually using tablet computers, or a control group (CG), in which members attended health education lectures unrelated to Go. Fluorine-18 fluorodeoxyglucose ( 18 F-FDG) positron emission tomography (PET), cognitive assessments, and Go tests were performed before and after the intervention.
RESULTS


The results showed different patterns of regional FDG uptake in both groups: regional cerebral glucose metabolism was significantly increased in the left middle temporal gyrus (MTG) and bilateral putamen (p < 0.01; cluster level) in the IG, and in the left superior frontal gyrus in the CG, (p < 0.01; cluster level). Furthermore, Go test scores were significantly improved in the IG (p < 0.05), and a significant association was observed between changes in Go test scores and glucose metabolism in the left MTG (p < 0.05).
CONCLUSIONS AND DISCUSSION


This study indicates that a cognitive intervention program using Go may enhance brain activity. Further studies with larger populations and longer observation periods are needed to clarify the neural mechanisms underlying our Go intervention program.",2020,"Furthermore, Go test scores were significantly improved in the IG (p < 0.05), and a significant association was observed between changes in Go test scores and glucose metabolism in the left MTG (p < 0.05).
",['Eighteen community-dwelling older adults'],"['cognitive intervention program', 'Fluorine-18 fluorodeoxyglucose ( 18 F-FDG) positron emission tomography (PET', 'cognitive intervention programs', 'intervention group (IG), in which members attended 12 Go lessons either in groups or individually using tablet computers, or a control group (CG), in which members attended health education lectures unrelated to Go']","['regional cerebral glucose metabolism', 'brain activity', 'Go test scores and glucose metabolism', 'left middle temporal gyrus (MTG) and bilateral putamen', 'regional FDG uptake']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0046056', 'cui_str': 'fludeoxyglucose (18F)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018701'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}]",18.0,0.0163148,"Furthermore, Go test scores were significantly improved in the IG (p < 0.05), and a significant association was observed between changes in Go test scores and glucose metabolism in the left MTG (p < 0.05).
","[{'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Iizuka', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan. aiizuka@tmig.or.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': 'Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Wagatsuma', 'Affiliation': 'Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Airin', 'Initials': 'A', 'LastName': 'Onishi', 'Affiliation': 'Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01462-6']
519,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
520,31253437,Changes in positive affect in cognitive-behavioral treatment of anxiety disorders.,"OBJECTIVE


This study evaluated changes in positive affect within cognitive-behavioral treatments (CBT) for anxiety disorders. It was hypothesized that there would be significantly greater increases in positive affect in CBT conditions compared to the waitlist, and particularly higher in the Unified Protocol (UP) than the single disorder protocols (SDP) given the UP's focus on emotions (including positive emotions) rather than symptoms.
METHOD


Patients with heterogeneous anxiety disorders (N = 223) were randomly assigned to the UP, SDP or waitlist. Linear mixed model regression (intent to treat) analyses were used to compare change in positive affect, quality of life, and savoring between patients in the treatment conditions (UP and SDP) versus waitlist conditions. Between condition effect sizes were calculated to assess the magnitude of difference within conditions at post-treatment.
RESULTS


Results indicated a significant Group (treatment vs. waitlist) × Time (pre- post-treatment) interaction (F(1, 154.36) = 6.75; p = .01) for positive affect in which the treatment group showed significant improvements in positive affect pre- to post-treatment (ESsg = 0.37, SEsg = 0.09, 95% CI [0.20: 0.54]) and the waitlist condition did not. There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
CONCLUSIONS


These results suggest CBT, which typically focuses on reductions in negative affect, may also improve positive affect. The importance of future research evaluating, targeting, and improving positive affect in CBT trials is discussed. Clinicaltrials.gov Identifier: NCT01243606.",2019,"There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
","['Patients with heterogeneous anxiety disorders (N\u202f=\u202f223', 'anxiety disorders']","['UP, SDP or waitlist', 'cognitive-behavioral treatments (CBT']","['UP and SDP conditions', 'quality of life, and savoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0034380'}]",223.0,0.0378923,"There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
","[{'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Wilner Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America. Electronic address: jwilner@bu.edu.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Amantia', 'Initials': 'A', 'LastName': 'Ametaj', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Olenka S', 'Initials': 'OS', 'LastName': 'Olesnycky', 'Affiliation': 'Department of Psychology, Hofstra University, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.06.008']
521,30649970,Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial.,"Children adopted internationally are often dysregulated biologically and behaviorally due to prior experiences of institutional care or caregiving changes and thus are in need of enhanced parental care. The present study assessed whether parents randomized to receive Attachment and Biobehavioral Catch-up (ABC) demonstrated significant improvements in parenting quality when compared to parents receiving a control intervention. Participants were 120 internationally adopted children and their adoptive parents. Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female. Children were adopted from several countries and predominantly from China, Russia, South Korea, and Ethiopia. The majority of parents identified themselves as White/non-Hispanic (95.0%). At the start of intervention, parents ranged in age from 26.2 to 51.1 years old ( M = 39.7,  SD  = 6.0), and children ranged in age from 6.8 months to 48.4 months ( M  = 21.9,  SD  = 9.0). Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy), and positive regard (i.e., positive affect expressed towards a child) were assessed at preintervention, immediately postintervention, and at annual follow-up visits. Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up. Findings add to the growing evidence that ABC improves parenting abilities, extending findings to adoptive parents and demonstrating that improvements in parenting quality were sustained several years after completion of the intervention. Trial registration: ClinicalTrials.gov NCT00816621.",2020,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","['parents ranged in age from 26.2 to 51.1\xa0years old (M=\xa039.7, SD\xa0=\xa06.0), and children ranged in age from 6.8\xa0months to 48.4\xa0months (M =\xa021.9, SD\xa0=\xa09.0', 'Participants were 120 internationally adopted children and their adoptive parents', 'Young Children', 'Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female']","['ABC', 'Attachment and Biobehavioral Catch-up (ABC', 'control intervention']","['Enhancing Parenting Quality', 'parenting abilities', 'parenting quality', ""Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy""]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0337541', 'cui_str': 'Adopted child (person)'}, {'cui': 'C0337466', 'cui_str': 'Adoptive parent (person)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}]",120.0,0.0406424,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health Center.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wallin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1547972']
522,31975496,"Treatment with 24 hour istaroxime infusion in patients hospitalised for acute heart failure: a randomised, placebo-controlled trial.","AIM


Istaroxime is a first-in-class agent which acts through inhibition of the sarcolemmal Na +  /K +  pump and activation of the SERCA2a pump. This study assessed the effects of a 24 h infusion of istaroxime in patients hospitalised for acute heart failure (AHF).
METHODS AND RESULTS


We included patients hospitalised for AHF with left ventricular ejection fraction ≤40% and E/e' > 10. Patients were randomised to a 24 h intravenous infusion of placebo or istaroxime at doses of 0.5 μg/kg/min (cohort 1: placebo n = 19; istaroxime n = 41) or 1.0 μg/kg/min (cohort 2: placebo n = 20, istaroxime n = 40). The primary endpoint of change in E/e' ratio from baseline to 24 h decreased with istaroxime vs. placebo (cohort 1: -4.55 ± 4.75 istaroxime 0.5 μg/kg/min vs. -1.55 ± 4.11 placebo, P = 0.029; cohort 2: -3.16 ± 2.59 istaroxime 1.0 μg/kg/min vs. -1.08 ± 2.72 placebo, P = 0.009). Both istaroxime doses significantly increased stroke volume index and decreased heart rate. Systolic blood pressure increased with istaroxime, achieving significance with the high dose. Self-reported dyspnoea and N-terminal pro-brain natriuretic peptide improved in all groups without significant differences between istaroxime and placebo. No significant differences in cardiac troponin absolute values or clinically relevant arrhythmias were observed during or after istaroxime infusion. Serious cardiac adverse events (including arrhythmias and hypotension) did not differ between placebo and istaroxime groups. The most common adverse events were injection site reactions and gastrointestinal events, the latter primarily with istaroxime 1.0 μg/kg/min.
CONCLUSIONS


In patients hospitalised for AHF with reduced ejection fraction, a 24 h infusion of istaroxime improved parameters of diastolic and systolic cardiac function without major cardiac adverse effects.",2020,Self-reported dyspnoea and N-terminal pro-brain natriuretic peptide improved in all groups without significant differences between istaroxime and placebo.,"[""patients hospitalised for AHF with left ventricular ejection fraction ≤40% and E/e' >\u200910"", 'patients hospitalised for acute heart failure', 'patients hospitalised for acute heart failure (AHF']","['placebo n\xa0=\xa019; istaroxime n\xa0=\xa041) or 1.0\u2009μg/kg/min (cohort 2: placebo', 'istaroxime vs. placebo', 'placebo or istaroxime', '24\u2009h infusion of istaroxime', '24\u2009hour istaroxime infusion', 'placebo']","['heart rate', 'cardiac troponin absolute values or clinically relevant arrhythmias', ""change in E/e' ratio from baseline to 24\u2009h"", 'diastolic and systolic cardiac function', 'Self-reported dyspnoea and N-terminal pro-brain natriuretic peptide', 'Systolic blood pressure', 'Serious cardiac adverse events (including arrhythmias and hypotension', 'stroke volume index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1172198', 'cui_str': 'Istaroxime'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.694701,Self-reported dyspnoea and N-terminal pro-brain natriuretic peptide improved in all groups without significant differences between istaroxime and placebo.,"[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Carubelli', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Civil Hospital of Brescia, Brescia, Italy.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Civil Hospital of Brescia, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Lombardi', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Civil Hospital of Brescia, Brescia, Italy.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Simmons', 'Affiliation': 'Windtree Therapeutics, Inc., Warrington, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Segal', 'Affiliation': 'Windtree Therapeutics, Inc., Warrington, PA, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Malfatto', 'Affiliation': 'IRCCS Istituto Auxologico Italiano, Department of Cardiovascular, Neural and Metabolic Sciences, S. Luca Hospital, Milan, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'La Rovere', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Department of Cardiology, Institute of Montescano, Pavia, Italy.'}, {'ForeName': 'Dianfu', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Jiangsu Provincial People's Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': ""The General Hospital of Shenyang Military Region of Chinese People's Liberation Arm, Shenyang, China.""}, {'ForeName': 'Zuyi', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': ""The First Affiliated Hospital of Xi'An Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Lee's Pharmaceutical Limited, Taipei, Taiwan.""}, {'ForeName': 'Lit Fui', 'Initials': 'LF', 'LastName': 'Lau', 'Affiliation': 'CVie Therapeutics Limited, Taipei, Taiwan.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bianchi', 'Affiliation': 'Windtree Therapeutics, Inc., Warrington, PA, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1743']
523,31706311,A randomized cross-over trial to determine the effect of a protein vs. carbohydrate preload on energy balance in ad libitum settings.,"BACKGROUND


Although high protein diets have been tested in controlled environments for applications to weight management, it is not understood if adding high protein foods to the diet would impact ad libitum energy balance in the absence of other lifestyle changes.
METHODS


This double-blinded randomized crossover trial compared the effects of a protein shake (PS) to a carbohydrate shake (CS), consumed prior to each major meal to equate to 20% of total energy needs over the course of the day, on energy balance over two 5-day treatment periods in healthy adults with BMI 20-30 kg/m2. Tri-axial accelerometers estimated physical activity energy expenditure. Ad libitum energy intake was measured in a laboratory kitchen.
RESULTS


Energy balance was positive during both treatment periods but was not different between periods. There were no interactions between treatment and preload caloric dose or treatment and BMI status on energy balance. Satiety ratings did not differ for any pairwise comparisons between treatment and caloric dose. Controlling for gender and basal metabolic rate, thermic effect of food was greater for PS than CS.
CONCLUSIONS


Preload periods significantly altered the macronutrient composition of the overall diet. This study found limited evidence that carbohydrate or protein preloads have differential effects on energy balance in short-term ad libitum settings.
TRIAL REGISTRATION


This trial was pre-registered on clinicaltrials.gov as NCT02613065 on 11/30/2015.",2019,Satiety ratings did not differ for any pairwise comparisons between treatment and caloric dose.,"['healthy adults with BMI 20-30\u2009kg/m2', 'ad libitum settings']","['protein vs. carbohydrate preload', 'protein shake (PS) to a carbohydrate shake (CS']","['Ad libitum energy intake', 'preload caloric dose or treatment and BMI status on energy balance', 'energy balance', 'Satiety ratings']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}]",,0.204171,Satiety ratings did not differ for any pairwise comparisons between treatment and caloric dose.,"[{'ForeName': 'Madeline J', 'Initials': 'MJ', 'LastName': 'Gibson', 'Affiliation': ""School of Public Health Dean's Office, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dawson', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Nadeeja N', 'Initials': 'NN', 'LastName': 'Wijayatunga', 'Affiliation': 'Department of Kinesiology and Sports Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Ironuma', 'Affiliation': 'Department of Kinesiology and Sports Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Idah', 'Initials': 'I', 'LastName': 'Chatindiara', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University College of Health, Auckland, New Zealand.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': ""School of Public Health Dean's Office, Indiana University, Bloomington, IN, USA.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Dhurandhar', 'Affiliation': 'Department of Kinesiology and Sports Management, Texas Tech University, Lubbock, TX, USA. emily.dhurandhar@ttu.edu.'}]",Nutrition journal,['10.1186/s12937-019-0497-4']
524,31953696,"A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer.","PURPOSE


The standard of care in the neoadjuvant setting for human epidermal growth factor receptor 2 (HER2)-positive breast cancer is dual HER2-targeted therapy. However, a need to minimize treatment-related toxicity and improve pathological complete response (pCR) rates, particularly in luminal HER2-positive disease, exists.
METHODS


Neopeaks, a randomized, phase 2 study, compared docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP; 6 cycles; group A), TCbHP (4 cycles) followed by trastuzumab emtansine + pertuzumab (T-DM1+P; 4 cycles; group B), and T-DM1+P (4 cycles; group C) regimens in HER2-positive primary breast cancer patients; concurrent hormone therapy with T-DM1+P was administered in case of estrogen receptor positivity (ER+). Based on tumor shrinkage, nonresponders in group C were switched to 5-fluorouracil + epirubicin + cyclophosphamide (FEC; 4 cycles). Primary endpoint was pCR (comprehensive pCR ypN0 [ypT0-TisypN0]).
RESULTS


Of 236 patients enrolled, 204 were randomized to groups A (n = 51), B (n = 52), and C (n = 101). In group C, 80 (79%) patients continued T-DM1+P following favorable response, whereas 21 (21%) nonresponders switched to FEC. pCR rate was numerically higher with the TCbHP →  T-DM1+P regimen (71%) versus the standard TCbHP (57%) and T-DM1+P (57%) regimens. The rate in group C was higher among responders continuing T-DM1+P (63%) versus nonresponders who switched to FEC (38%). pCR rates after initial 4 cycles of T-DM1+P (group C; 57%) and standard TCbHP regimen (57%) were equivalent. pCR rate in patients with ER+ was significantly higher in group B (69%) than groups A (43%) and C (51%), but was comparable in patients with ER- (67-76%). Compared with the T-DM1-based arm, the incidence of adverse events was higher in the taxane-based arms.
CONCLUSION


In the neoadjuvant setting, the pCR rate with the standard TCbHP →  T-DM1+P regimen was numerically better than the TCbHP regimen alone and significantly better in patients with ER+. Personalization of the T-DM1+P regimen could serve as a reasonable approach to minimize toxicity while maintaining efficacy. Trial registration ID: UMIN-CTR: UMIN000014649.",2020,"rate in patients with ER+ was significantly higher in group B (69%) than groups A (43%) and C (51%), but was comparable in patients with ER- (67-76%).","['HER2-positive primary breast cancer', 'HER2-positive primary breast cancer patients', '236 patients enrolled, 204', 'human epidermal growth factor receptor 2']","['T-DM1+P', 'docetaxel\u2009+\u2009carboplatin\u2009+\u2009trastuzumab\u2009+\u2009pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P', 'concurrent hormone therapy with T-DM1+P', 'comprehensive pCR', 'ypN0', 'pCR', 'UMIN-CTR', 'docetaxel\u2009+\u2009carboplatin\u2009+\u2009trastuzumab\u2009+\u2009pertuzumab (TCbHP', 'TCbHP (4 cycles) followed by trastuzumab emtansine\u2009+\u2009pertuzumab', 'standard TCbHP', 'TCbHP', '5-fluorouracil\u2009+\u2009epirubicin\u2009+\u2009cyclophosphamide (FEC']","['incidence of adverse events', 'pCR rates', 'pathological complete response (pCR) rates', 'rate', 'pCR rate', 'pCR ']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",204.0,0.0260263,"rate in patients with ER+ was significantly higher in group B (69%) than groups A (43%) and C (51%), but was comparable in patients with ER- (67-76%).","[{'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Suzuki', 'Affiliation': 'Department of Breast Surgery, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Surgery, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kuroi', 'Affiliation': 'Department of Breast Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yasojima', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroi', 'Initials': 'H', 'LastName': 'Kasai', 'Affiliation': 'Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takasuka', 'Affiliation': 'Oncology Lifecycle Management Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Tatsuki R', 'Initials': 'TR', 'LastName': 'Kataoka', 'Affiliation': 'Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Breast Cancer Unit, Kyoto University Hospital, Kyoto University, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan. toi@kuhp.kyoto-u.ac.jp.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05524-6']
525,31630566,Community-Partnered Evaluation of the Aging Mastery Program in Los Angeles Area Senior Centers.,"Background.  The National Council on Aging's Aging Mastery Program (AMP) aims to help older adults implement health behavior and lifestyle changes to promote healthy aging and social engagement. The purpose of the present community-partnered evaluation was to test the effectiveness of AMP implementation in Los Angeles County to improve participants' quality of life, global physical and mental health, and patient activation.  Method.  A modified randomized wait-list controlled trial design was used to examine experimental, quasi-experimental, and dose-response evidence in five senior centers. Participants completed questionnaires at baseline and after the 10-week intervention, self-reporting their overall quality of life, physical health, mental health, and patient activation.  Results.  Experimental, intention-to-treat analyses found AMP assignment did not affect any measured outcomes ( n  = 71). Quasi-experimental, ""as treated"" analyses ( n  = 106) controlling for study site and sociodemographic characteristics indicated that participants who attended AMP reported more positive changes in global mental health than the control group. Attending AMP was not associated with changes in quality of life, physical health, or patient activation. Dose-response analyses among AMP participants who attended at least one class ( n  = 75) found that attending more classes was not significantly associated with greater improvements in mental health.  Conclusions.  Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health. Recruitment challenges and participants' nonadherence with condition assignment decreased our ability to detect effects. https://clinicaltrials.gov/ct2/show/NCT03342729?term=Aging+Mastery+Program&rank=1 .",2020,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","['five senior centers', 'Los Angeles Area Senior Centers']",['Mastery Program (AMP'],"['quality of life, physical health, or patient activation', 'global mental health', 'self-reporting their overall quality of life, physical health, mental health, and patient activation', 'quality of life, physical or mental health, or patient activation', ""participants' quality of life, global physical and mental health, and patient activation"", 'mental health']","[{'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]","[{'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",5.0,0.0743711,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","[{'ForeName': 'Lourdes R', 'Initials': 'LR', 'LastName': 'Guerrero', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Josephine A', 'Initials': 'JA', 'LastName': 'Menkin', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Carrillo', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen E', 'Initials': 'CE', 'LastName': 'Reyes', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Trejo', 'Affiliation': 'City of Los Angeles Department of Aging, Los Angeles, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Aging and Community Services, Los Angeles, CA, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sarkisian', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119882992']
526,30843046,"Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.","BACKGROUND


The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy.
METHODS


In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2.
RESULTS


Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups.
CONCLUSIONS


RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose.
CLINICAL TRIALS REGISTRATION


NCT02058589.",2020,gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across post-vaccination time points and persisted above pre-vaccination baseline 12M post-dose 2.,"['chronically immunosuppressed RT recipients', 'Chronically Immunosuppressed Adults Following Renal Transplant', 'renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy', '264 participants (RZV: 132; Placebo: 132) were enrolled between March 2014 and April 2017']","['adjuvanted recombinant zoster vaccine (RZV', 'placebo', 'RZV or Placebo', 'RZV', 'Adjuvanted Recombinant Zoster Vaccine']","['Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates', 'Overall occurrences of renal function changes, rejections, unsolicited AEs, SAEs, and pIMDs', 'Solicited and unsolicited adverse events (AEs', 'Immunogenicity and Safety', 'immunogenicity and safety', 'Immunogenicity', 'gE-specific humoral and cell-mediated immune responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",,0.592793,gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across post-vaccination time points and persisted above pre-vaccination baseline 12M post-dose 2.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vink', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Ramon Torrell', 'Affiliation': 'Bellvitge University Hospital, Barcelona.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sanchez Fructuoso', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Sung-Joo', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Sungkyunkwan University, Canada.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': ""Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Zaltzman', 'Affiliation': ""St Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Ortiz', 'Affiliation': 'Helsinki University Hospital, Finland.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Campistol Plana', 'Affiliation': ""Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer.""}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Fernandez Rodriguez', 'Affiliation': 'Hospital Ramón y Cajal, Madrid.'}, {'ForeName': 'Henar', 'Initials': 'H', 'LastName': 'Rebollo Rodrigo', 'Affiliation': 'University Hospital Valdecilla, Santander.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Campins Marti', 'Affiliation': ""Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perez', 'Affiliation': 'Social Security of Panama, Panama City.'}, {'ForeName': 'Francisco Manuel', 'Initials': 'FM', 'LastName': 'González Roncero', 'Affiliation': 'Hospital Universitario Virgen Rocio, Sevilla, Spain.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Yang-Jen', 'Initials': 'YJ', 'LastName': 'Chiang', 'Affiliation': 'Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Doucette', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Pipeleers', 'Affiliation': 'UZ Brussel, Belgium.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Agüera Morales', 'Affiliation': 'Hospital Universitario Reina Sofia, Córdoba.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Rodriguez-Ferrero', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Secchi', 'Affiliation': 'Vita Salute San Reffaele University, Milan, Italy.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, Izaak Walton Killam Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Fauqued', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Salaun', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, King of Prussia, Pennsylvania.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz177']
527,31432089,Effects of early nutritional intervention on oral mucositis in patients with radiotherapy for head and neck cancer.,"BACKGROUND


To observe the effect of early nutritional intervention on radiation-induced oral mucositis and nutritional status in patients with head and neck cancer (HNC).
METHODS


A total of 54 HNC patients were divided into early (28 cases) and late (26 cases) nutritional intervention groups. The early group received enteral nutrition at the beginning of radiotherapy (RT), while the late group received enteral nutrition after restricted feeding. Operators reported and assessed the timing and extent of oral mucositis and nutritional status during treatment. The nutritional status assessment indicators included body weight; body mass index (BMI); Patient-Generated-Subjective Global Assessment (PG-SGA) score; levels of albumin, hemoglobin and pre-albumin and total lymphocyte count.
RESULTS


The incidence of high-grade oral mucositis was significantly lower in the early group than that in the late group (P < 0.05). Nutritional status assessments showed more significant weight and BMI losses in the late group than in the early group at weeks 4 and 7 after RT (P < 0.01). The albumin decreased in the late group at week 7 after RT was more significant than that in the early group (P < 0.05). Albumin, hemoglobin and pre-albumin levels and total lymphocyte count decreased significantly in both groups (P > 0.05). During therapy, more patients in the early group were well-nourished and fewer were malnourished according to PG-SGA scores (P < 0.05).
CONCLUSION


Early nutritional intervention can reduce the incidence of high-grade oral mucositis during RT in patients with HNC and improve the nutritional status during treatment, which has important clinical significance.",2020,"Early nutritional intervention can reduce the incidence of high-grade oral mucositis during RT in patients with HNC and improve the nutritional status during treatment, which has important clinical significance.","['54 HNC patients were divided into early (28 cases) and late (26 cases) nutritional intervention groups', 'Patients with Radiotherapy for Head and Neck Cancer', 'patients with head and neck cancer (HNC']","['enteral nutrition at the beginning of radiotherapy (RT), while the late group received enteral nutrition', 'early nutritional intervention', 'Early Nutritional Intervention']","['PG-SGA scores', 'incidence of high-grade oral mucositis', 'oral mucositis and nutritional status', 'body weight; body mass index (BMI); Patient-Generated-Subjective Global Assessment (PG-SGA) score; levels of albumin, hemoglobin, and pre-albumin; and total lymphocyte count', 'Albumin, hemoglobin, and pre-albumin levels and total lymphocyte count', 'weight and BMI losses', 'Oral Mucositis', 'albumin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0125255,"Early nutritional intervention can reduce the incidence of high-grade oral mucositis during RT in patients with HNC and improve the nutritional status during treatment, which has important clinical significance.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Internal Medicine, Florida Hospital, 7727 Lake Underhill Rd, Orlando, FL, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Jilin University, 1163 Xinmin Street, Changchun, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'The Key Laboratory of Pathobiology, Ministry of Education, Jilin University, 126 Xinmin Street, Changchun, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, China.'}]",QJM : monthly journal of the Association of Physicians,['10.1093/qjmed/hcz222']
528,31139982,Laparoscopic versus open appendectomy for perforated appendicitis in adults: randomized clinical trial.,"BACKGROUND


The advantages of laparoscopic appendectomy did not meet the same acceptance in the setting of perforated appendicitis as in uncomplicated appendicitis in the general surgical community. The aim of this study was to compare the clinical outcome of laparoscopic and open appendectomy in perforating appendicitis.
METHODS


A randomized controlled study was conducted on 126 patients presenting with perforated appendicitis. Sixty patients were subjected to laparoscopic appendectomy (LA) and 66 patients underwent traditional open appendectomy (OA).
RESULTS


65 (51.6%) patients were female, and 61 (48.4%) patients were male in whom the mean age was 37.6 + 8.5 years. A significant difference was calculated in the domains of postoperative pain, less need for analgesics, hospital stay, and return to daily activities. The mean operative time was shorter in OA 94 ± 10.4 min than LA 120.6 ± 17.7 min. No statistically significant difference between both groups was detected as regard occurrence of intra-abdominal collection.
CONCLUSION


In view of its clinical outcomes, laparoscopy should be considered in the context of perforated appendicitis. The possibility of intra-abdominal collection should not be a barrier against the widespread practice of this surgical procedure amidst laparoscopic surgeons if adequate precautions are employed.",2020,"A significant difference was calculated in the domains of postoperative pain, less need for analgesics, hospital stay, and return to daily activities.","['Sixty patients were subjected to', 'perforated appendicitis in adults', '65 (51.6%) patients were female, and 61 (48.4%) patients were male in whom the mean age was 37.6\u2009+\u20098.5\xa0years', '126 patients presenting with perforated appendicitis']","['laparoscopic appendectomy', 'laparoscopic appendectomy (LA', 'laparoscopic and open appendectomy', 'Laparoscopic versus open appendectomy', 'traditional open appendectomy (OA']","['mean operative time', 'postoperative pain, less need for analgesics, hospital stay, and return to daily activities', 'regard occurrence of intra-abdominal collection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0401020', 'cui_str': 'Intra-abdominal collection (disorder)'}]",126.0,0.0706365,"A significant difference was calculated in the domains of postoperative pain, less need for analgesics, hospital stay, and return to daily activities.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Talha', 'Affiliation': 'Medical Research Institute, Alexandria University, 165, Horreya Avenue, Hadara, Alexandria, 21561, Egypt. ahmedtalha047@yahoo.com.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'El-Haddad', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Abd-Elhamid', 'Initials': 'AE', 'LastName': 'Ghazal', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Shehata', 'Affiliation': 'Medical Research Institute, Alexandria University, 165, Horreya Avenue, Hadara, Alexandria, 21561, Egypt.'}]",Surgical endoscopy,['10.1007/s00464-019-06847-2']
529,31924158,Pomegranate Juice does not Affect the Bioavailability of Cyclosporine in Healthy Thai Volunteers.,"BACKGROUND


It is still controversial whether pomegranate causes drug interactions. Pomegranate juice has been shown to inhibit CYP3A in-vitro and animal studies. The coadministration of pomegranate juice with cyclosporine, a narrow therapeutic drug that is the substrate of CYP3A, might lead to drug toxicity. The objective of this study is to investigate the effect of pomegranate juice on the pharmacokinetics of cyclosporine in healthy Thai volunteers.
METHODS


The study design was an open-label, randomized, single dose, crossover study with a 2- week washout period. Each fasting subject received 2 microemulsion tablets of 100 mg of cyclosporine with 500 ml of pomegranate juice (test) or 500 ml of water (control). Serial blood samples were collected up to 24 h after dosing, and blood samples were analyzed for cyclosporine concentrations by using chemiluminescent microparticle immunoassay. Fourteen healthy volunteers completed the study.
RESULTS


The 90% confidence intervals for the test/control ratio using logarithmically transformed data of area under the concentration-time curve (AUC) from time zero until the last measured concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax) were 91.6-105.6, 92.0-105.2 and 82.3-102.5, respectively. The results were within the accepted bioequivalence range for narrow therapeutic index drugs (90-111% for AUC and 80-125% for Cmax). There were no differences in adverse event between the groups.
CONCLUSION


Single dose administration of pomegranate juice with cyclosporine did not significantly affect the oral bioavailability of cyclosporine. However, further work is needed to thoroughly evaluate the effect of pomegranate on narrow therapeutic drugs.",2020,"There were no differences in adverse event between groups.
","['Healthy Thai Volunteers', 'healthy Thai volunteers', 'Fourteen healthy volunteers completed the study']","['cyclosporine with 500 ml of pomegranate juice (test) or 500 ml of water (control', 'cyclosporine', 'pomegranate juice']","['Bioavailability of Cyclosporine', 'Serial blood samples', 'adverse event', 'oral bioavailability of cyclosporine', 'concentration-time curve (AUC) from time zero until the last measured concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax']","[{'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",14.0,0.0545448,"There were no differences in adverse event between groups.
","[{'ForeName': 'Wirin', 'Initials': 'W', 'LastName': 'Anlamlert', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Pakawadee', 'Initials': 'P', 'LastName': 'Sermsappasuk', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}]",Current clinical pharmacology,['10.2174/1574884715666200110153125']
530,31971616,Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,"BACKGROUND


The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair.
METHODS


This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years.
RESULTS


Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047).
CONCLUSION


Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).",2020,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"['Eighty patients were randomized', 'patients undergoing', 'patients undergoing laparoscopic umbilical hernia mesh repair']","['laparoscopic umbilical hernia repair', 'elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair']","['early and late postoperative pain', 'Recurrence (clinical and reoperation) and chronic pain', 'early seroma formation and long-term recurrence', 'Postoperative pain, movement limitations, discomfort and fatigue', 'Median defect sizes', 'Cumulative recurrence', 'outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain', 'Seroma formation, quality of life and cosmesis', 'Seroma formation']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306503', 'cui_str': 'Exomphalos'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia (procedure)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}]",80.0,0.649892,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Christoffersen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Herlev Hospital, University of Copenhagen, Copenhagen.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Helgstrand', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bisgaard', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}]",The British journal of surgery,['10.1002/bjs.11490']
531,31672939,Salt increases monocyte CCR2 expression and inflammatory responses in humans.,"Inflammation may play a role in the link between high salt intake and its deleterious consequences. However, it is unknown whether salt can induce proinflammatory priming of monocytes and macrophages in humans. We investigated the effects of salt on monocytes and macrophages in vitro and in vivo by performing a randomized crossover trial in which 11 healthy human subjects adhered to a 2-week low-salt and high-salt diet. We demonstrate that salt increases monocyte expression of CCR2, a chemokine receptor that mediates monocyte infiltration in inflammatory diseases. In line with this, we show a salt-induced increase of plasma MCP-1, transendothelial migration of monocytes, and skin macrophage density after high-salt diet. Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet. Taken together, our data open up the possibility for inflammatory monocyte and macrophage responses as potential contributors to the deleterious effects of high salt intake.",2019,"Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet.","['11 healthy human subjects adhered to a 2-week low-salt and high-salt diet', 'humans']",[],"['monocyte CCR2 expression and inflammatory responses', 'cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages', 'plasma MCP-1, transendothelial migration of monocytes, and skin macrophage density']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2936223', 'cui_str': 'Endothelial Transmigration'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",11.0,0.0109655,"Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet.","[{'ForeName': 'Eliane Fe', 'Initials': 'EF', 'LastName': 'Wenstedt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Sanne Gs', 'Initials': 'SG', 'LastName': 'Verberk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Molecular Cell Biology and Immunology, Amsterdam Cardiovascular Sciences, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Experimental Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Neele', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Baardman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Nike', 'Initials': 'N', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Pathology, Amsterdam, Netherlands.'}, {'ForeName': 'Özge T', 'Initials': 'ÖT', 'LastName': 'Pasaoglu', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rademaker', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Esmee M', 'Initials': 'EM', 'LastName': 'Schrooten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Wouda', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Menno Pj', 'Initials': 'MP', 'LastName': 'de Winther', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Pathology, Amsterdam, Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Van den Bossche', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Molecular Cell Biology and Immunology, Amsterdam Cardiovascular Sciences, Cancer Center Amsterdam, Amsterdam, Netherlands.'}]",JCI insight,['10.1172/jci.insight.130508']
532,31672941,Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion.,"BACKGROUNDInsulin resistance results from impaired skeletal muscle glucose transport/phosphorylation, linked to augmented lipid availability. Despite greater intramuscular lipids, athletes are highly insulin sensitive, which could result from higher rates of insulin-stimulated glycogen synthesis or glucose transport/phosphorylation and oxidation. Thus, we examined the time course of muscle glycogen and glucose-6-phosphate concentrations during low and high systemic lipid availability.METHODSEight endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline in a randomized crossover design. Glycogen and glucose-6-phosphate concentrations were monitored in vastus lateralis muscles using 13C/31P magnetic resonance spectroscopy.RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants. During Intralipid infusion, insulin sensitivity remained higher in the athletes (ΔRd: 25 ± 3 vs. 17 ± 3 μmol/kg/min, P < 0.05), supported by higher glucose transporter type 4 protein expression than in sedentary humans. Compared to saline infusion, AUC of glucose-6-phosphate remained unchanged during Intralipid infusion in athletes (1.6 ± 0.2 mmol/L vs. 1.4 ± 0.2 [mmol/L] × h, P = n.s.) but tended to decrease by 36% in sedentary humans (1.7 ± 0.4 vs. 1.1 ± 0.1 [mmol/L] × h, P < 0.059). This drop was accompanied by a 72% higher rate of net glycogen synthesis in the athletes upon Intralipid infusion (47 ± 9 vs. 13 ± 3 μmol/kg/min, P < 0.05).CONCLUSIONAthletes feature higher skeletal muscle glucose disposal and glycogen synthesis during increased lipid availability, which primarily results from maintained insulin-stimulated glucose transport with increased myocellular glucose-6-phosphate levels for subsequent glycogen synthesis.TRIAL REGISTRATIONClinicalTrials.gov NCT01229059.FUNDINGGerman Federal Ministry of Health (BMG).",2019,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,[],"['endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline']","['Glycogen and glucose-6-phosphate concentrations', 'insulin sensitivity', 'time course of muscle glycogen and glucose-6-phosphate concentrations', 'AUC of glucose-6-phosphate', 'insulin-stimulated glucose disposal rate (Rd', 'net glycogen synthesis', 'muscle glucose transport and glycogen synthesis']",[],"[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0672761', 'cui_str': 'glycerol-6-phosphate transporter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}]",,0.0359948,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Begovatz', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bierwagen', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.127928']
533,31753737,Methadone treatment of arrestees: A randomized clinical trial.,"BACKGROUND


Opioid use disorder is common among detainees in US jails, yet methadone treatment is rarely initiated.
METHODS


This is a three-group randomized controlled trial in which 225 detainees in Baltimore treated for opioid withdrawal were assigned to: (1) interim methadone (IM) with patient navigation (IM + PN); (2) IM; or (3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to enter standard methadone treatment upon release, while ETAU participants received an assessment/referral number. Follow-up assessments at 1, 3, 6, and 12 months post-release determined treatment enrollment, urine drug testing results, self-reported days of drug use, criminal activity, and overdose events. Generalized linear mixed modelling examined two planned contrasts: (1) IM groups combined vs. ETAU; and (2) IM + PN vs. IM.
RESULTS


On an intention-to-treat basis, compared to ETAU, significantly more participants in the combined IM groups were in treatment 30 days post-release, while the IM + PN vs. IM groups did not significantly differ. By month 12, there were no significant differences in the estimated marginal means of enrollment in any kind of drug treatment (0.40 and 0.27 for IM + PN and IM groups, respectively, compared to 0.29 for ETAU). There were no significant differences for either contrast in opioid-positive tests, although all groups reported a sharp decrease in heroin use from baseline to follow-up. There were five fatal overdoses, but none occurred during methadone treatment.
CONCLUSION


Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.",2020,Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.,['225 detainees in Baltimore treated for opioid withdrawal'],"['methadone', 'methadone (IM) with patient navigation (IM\u202f+\u202fPN); (2) IM; or (3) enhanced treatment-as-usual (ETAU', 'Methadone']","['urine drug testing results, self-reported days of drug use, criminal activity, and overdose events', 'heroin use']","[{'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0042037'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0851832', 'cui_str': 'Criminal activity'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.114502,Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.,"[{'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: Rschwartz@friendsresearch.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: skelly@friendsresearch.org.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: smitchell@friendsresearch.org.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA. Electronic address: ogrady@umd.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: asharma@friendsresearch.org.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Jaffe', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: jhjaffe@aol.com.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107680']
534,31932201,The association of vitamin D with hepatitis B virus replication: Bystander rather than offender.,"BACKGROUND/PURPOSE


Low vitamin D is frequent in hepatitis B virus (HBV)-infected patients and several studies show an inverse association of serum vitamin D level with HBV viral load. However, the causal relationship remains unclear.
METHODS


HBV carriers receiving regular 6-month surveillance without current antiviral treatment or cirrhosis were invited to participate into this trial. The markers of HBV replication included serum HBV DNA and quantitative HBsAg (qHBsAg) levels. Those with undetectable HBV DNA or sufficient vitamin D levels, cancer or electrolyte imbalance were excluded. The eligible subjects were randomized to receive either vitamin D supplement 2000 IU per day for 2 months (vitamin D group) or none (control group).
RESULTS


A total of 196 HBV carriers (93 males and 103 females; mean age 51.9 ± 10.0 years) were screened. Of them, 28 patients had undetectable serum HBV DNA levels, which is defined as spontaneous viral clearance. The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18). After exclusion, 149 patients were randomized to two groups: 75 in vitamin D group and 74 in control group. After 2 months vitamin D supplement, the serum vitamin D levels were significantly higher in the vitamin D group than the control group (p < 0.001). However, the serum qHBsAg and HBV DNA levels were comparable between these two groups.
CONCLUSION


There is no causal relationship between vitamin D and HBV replication. The role of liver reserve on serum vitamin D levels in patients with chronic HBV infection needs further investigation.",2020,The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18).,"['HBV carriers receiving regular 6-month surveillance without current antiviral treatment or cirrhosis', 'hepatitis B virus (HBV)-infected patients', '149 patients', '196 HBV carriers (93 males and 103 females; mean age 51.9\xa0±\xa010.0 years) were screened', 'patients with chronic HBV infection needs further investigation']","['vitamin D', 'vitamin D supplement 2000 IU per day for 2 months (vitamin D group) or none (control group']","['vitamin D levels', 'serum qHBsAg and HBV DNA levels', 'serum vitamin D levels', 'undetectable serum HBV DNA levels', 'serum HBV DNA and quantitative HBsAg (qHBsAg) levels', 'spontaneous viral clearance']","[{'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",149.0,0.0402298,The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18).,"[{'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. Electronic address: uld888@yahoo.com.tw.'}, {'ForeName': 'I-Shiang', 'Initials': 'IS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Research, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chung-Hsien', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Hans Hsienhong', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chun-Chun', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Laboratory Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan.'}, {'ForeName': 'Jia-Horng', 'Initials': 'JH', 'LastName': 'Kao', 'Affiliation': 'Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taiwan.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.12.004']
535,31926597,Evaluation of emergence agitation after general anaesthesia in rhinoplasty patients: Inhalation anaesthesia versus total intravenous anaesthesia.,"BACKGROUND


Emergence agitation (EA) is a clinical condition that occurs early in recovery from general anaesthesia, and reduces patient comfort. The aim of this study was to compare the effects of low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA) on agitation in rhinoplasty patients, and to determine the frequency of EA in low flow sevoflurane anaesthesia after rhinoplasty.
MATERIAL AND METHODS


A total of 90 rhinoplasty patients, under general anaesthesia were included in this prospective randomised study. After induction of anaesthesia, propofol infusion was initiated in the TIVA group (n = 45), and sevoflurane was administered in the SEVO group with a fresh gas flow of 1 l/min and MAC (minimum alveolar concentration) 1-1.1 (n = 45). Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting were recorded at the end of surgery.
RESULTS


Early emergence time was significantly shorter in the TIVA group, than in the SEVO group (p < 0.001). İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001). The ratio of patients with RASS > +1 for all patients was 35.6% at 0 min, postoperatively. This rate was 12.2% (n = 11) in the TIVA group, and 23.3% (n = 21) in the SEVO group (p = 0.028).
CONCLUSIONS


In rhinoplasty, TIVA caused shorter early emergence times, less bleeding, high surgeon satisfaction, and lower EA scores when compared with low flow sevoflurane anaesthesia.",2020,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","['90 rhinoplasty patients, under general anaesthesia', 'rhinoplasty patients']","['sevoflurane', 'anaesthesia, propofol infusion', 'anaesthesia versus total intravenous anaesthesia', 'low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA']","['Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting', 'surgical field image quality and surgeon satisfaction', 'bleeding, high surgeon satisfaction, and lower EA scores', 'İntraoperative bleeding']","[{'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0222045'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0313933,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Talih', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey. Electronic address: gamzetalih@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yüksek', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Şahin', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Bozok University Yozgat, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102387']
536,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
537,30888448,Superior knee flexor strength at 2 years with all-inside short-graft anterior cruciate ligament reconstruction vs a conventional hamstring technique.,"PURPOSE


To compare the ""all-inside technique"" for anterior cruciate ligament (ACL) reconstruction using a short, quadrupled semitendinosus tendon (ST4) autograft and suspensory cortical fixation on both the femoral and tibial side vs the ""conventional technique"" using a semitendinosus/gracilis (ST/G) autograft fixed with a suspensory device on the femoral side and with an interference screw on the tibial side, in terms of clinical and functional outcomes.
METHODS


A total of 90 patients were enrolled, randomised into two groups, and prospectively followed. Group A comprised 45 patients treated with the all-inside technique and Group B included 45 patients treated with the conventional ACL technique (55 males, 35 females; mean age 28.7 ± 11.3 years). Patients completed the Lysholm knee score, the International Knee Documentation Committee (IKDC) score, the Knee Injury and Osteoarthritis Score (KOOS), and the Knee Society Score (KSS) preoperatively and at 2 years postoperatively. Anterior tibial translation measurement (KT-1000 arthrometer) and isokinetic testing of the operative vs non-operative limb were also conducted and the limb symmetry index (LSI) was determined.
RESULTS


At 24 months, the Lysholm, IKDC, KOOS, and KSS scores between the two groups were similar (n.s.). Anterior tibial translation between the operative and non-operative knee was also similar among the two groups (n.s.). Patients of Group A had significantly higher mean LSIs in terms of flexor peak torque (1.0 ± 0.1 vs 0.9 ± 0.1; p < 0.001), time-to-peak (0.9 ± 0.1 vs 0.8 ± 0.1; p < 0.001) and total work (0.9 ± 0.1 vs 0.8 ± 0.1; p < 0.001) at 180°/s, and significantly better mean LSI for isometric flexor/extensor ratio at 90° (1.1 ± 0.3 vs 0.8 ± 0.2; p < 0.001).
CONCLUSION


The all-inside ACL reconstruction with an ST4 autograft and cortical button fixation on both ends is a viable alternative to the conventional technique. It affords preservation of knee flexor strength, which is of advantage, especially when treating athletes with ACL injury.
LEVEL OF EVIDENCE


I.",2019,"At 24 months, the Lysholm, IKDC, KOOS, and KSS scores between the two groups were similar (n.s.).","['athletes with ACL injury', '55 males, 35 females; mean age 28.7\u2009±\u200911.3\xa0years', 'A total of 90 patients']","['conventional technique"" using a semitendinosus/gracilis (ST/G) autograft fixed with a suspensory device', 'ST4 autograft and cortical button fixation', 'Superior knee flexor strength at 2\xa0years with all-inside short-graft anterior cruciate ligament reconstruction vs a conventional hamstring technique', 'all-inside technique"" for anterior cruciate ligament (ACL) reconstruction using a short, quadrupled semitendinosus tendon (ST4) autograft and suspensory cortical fixation', 'conventional ACL technique']","['mean LSIs', 'Lysholm, IKDC, KOOS, and KSS scores', 'Anterior tibial translation between the operative and non-operative knee', 'time-to-peak', 'flexor peak torque', 'Lysholm knee score, the International Knee Documentation Committee (IKDC) score, the Knee Injury and Osteoarthritis Score (KOOS), and the Knee Society Score (KSS', 'mean LSI for isometric flexor/extensor ratio', 'limb symmetry index (LSI', 'Anterior tibial translation measurement (KT-1000 arthrometer) and isokinetic testing']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0210233', 'cui_str': 'recombinant soluble CD4'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0921292', 'cui_str': 'Semitendinosus Tendon'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer (physical object)'}]",90.0,0.0176633,"At 24 months, the Lysholm, IKDC, KOOS, and KSS scores between the two groups were similar (n.s.).","[{'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Kouloumentas', 'Affiliation': 'Orthopaedics and Sports Orthopaedics Clinic, Metropolitan Hospital, Ethnarchou Makariou 9 & El. Venizelou 1, N. Faliro, 18547, Piraeus, Greece. info@kouloumentas.gr.'}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Kavroudakis', 'Affiliation': 'Orthopaedics and Sports Orthopaedics Clinic, Metropolitan Hospital, Ethnarchou Makariou 9 & El. Venizelou 1, N. Faliro, 18547, Piraeus, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Charalampidis', 'Affiliation': 'Orthopaedics and Sports Orthopaedics Clinic, Metropolitan Hospital, Ethnarchou Makariou 9 & El. Venizelou 1, N. Faliro, 18547, Piraeus, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Kavroudakis', 'Affiliation': 'Department of Geography, University of the Aegean, Mytilene, Lesvos Island, Greece.'}, {'ForeName': 'Georgios K', 'Initials': 'GK', 'LastName': 'Triantafyllopoulos', 'Affiliation': 'Orthopaedics and Sports Orthopaedics Clinic, Metropolitan Hospital, Ethnarchou Makariou 9 & El. Venizelou 1, N. Faliro, 18547, Piraeus, Greece.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05456-9']
538,31913324,Impact of an integrated mother-preterm infant intervention on birth hospitalization charges.,"OBJECTIVE


To examine whether the H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) intervention reduced birth hospitalization charges yielding net savings after adjusting for intervention costs.
STUDY DESIGN


One hundred and twenty-one mother-preterm infant dyads randomized to H-HOPE or a control group had birth hospitalization data. Neonatal intensive care unit costs were based on billing charges. Linear regression, propensity scoring and regression analyses were used to describe charge differences.
RESULTS


Mean H-HOPE charges were $10,185 lower than controls (p = 0.012). Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants. Cost savings increased as hospital charges increased. The mean intervention cost was $680 per infant.
CONCLUSIONS


Lower birth hospitalization charges and the net cost savings of H-HOPE infants support implementation of H-HOPE as the standard of care for preterm infants.",2020,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[""Preterm Infant's Environment"", 'One hundred and twenty-one mother-preterm infant dyads randomized to', 'preterm infants']","['H-HOPE', 'H-HOPE (Hospital to Home', 'integrated mother-preterm infant intervention']","['birth hospitalization data', 'mean intervention cost', 'Mean H-HOPE charges', 'birth hospitalization charges', 'Cost savings']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",121.0,0.0351533,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Vonderheid', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. vonde@uic.edu.'}, {'ForeName': 'Chang G', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0567-7']
539,31940011,Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.,"Importance


Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths.
Objective


To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood symptoms.
Design, Settings, and Participants


This multisite randomized clinical trial included referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II. Recruitment started from October 6, 2011, and ended on September 15, 2016. Independent evaluators interviewed participants every 4 to 6 months to measure symptoms for up to 4 years. Data analysis was performed from March 13 to November 3, 2019.
Interventions


High-risk youths and parents were randomly allocated to FFT (12 sessions in 4 months of psychoeducation, communication training, and problem-solving skills training; n = 61) or enhanced care (6 sessions in 4 months of family and individual psychoeducation; n = 66). Youths could receive medication management in either condition.
Main Outcomes and Measures


The coprimary outcomes, derived using weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery. Secondary outcomes were time to conversion to bipolar disorder I or II and longitudinal symptom trajectories.
Results


All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years) were followed up for a median of 98 weeks (range, 0-255 weeks). No differences were detected between treatments in time to recovery from pretreatment symptoms. High-risk youths in the FFT group had longer intervals from recovery to the emergence of the next mood episode (χ2 = 5.44; P = .02; hazard ratio, 0.55; 95% CI, 0.48-0.92;), and from randomization to the next mood episode (χ2 = 4.44; P = .03; hazard ratio, 0.59; 95% CI, 0.35-0.97) than youths in enhanced care. Specifically, FFT was associated with longer intervals to depressive episodes (log-rank χ2 = 6.24; P = .01; hazard ratio, 0.53; 95% CI, 0.31-0.88) but did not differ from enhanced care in time to manic or hypomanic episodes, conversions to bipolar disorder, or symptom trajectories.
Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes. Clarifying the relationship between changes in family functioning and changes in the course of high-risk syndromes merits future investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT01483391.",2020,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","['Interventions\n\n\nHigh-risk youths and parents', 'Symptomatic Youths at High Risk for Bipolar Disorder', 'referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II', 'youths who have parents with bipolar disorder', 'All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years', 'high-risk youths']","['Family-Focused Therapy vs Enhanced Usual Care', 'family-focused therapy (FFT', 'psychoeducation, communication training, and problem-solving skills training; n\u2009=\u200961) or enhanced care (6 sessions in 4 months of family and individual psychoeducation', 'standard psychoeducation', 'FFT']","['weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery', 'time to conversion to bipolar disorder I or II and longitudinal symptom trajectories', 'longer intervals to depressive episodes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]",127.0,0.142508,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Suddath', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Forgey Borlik', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private practice, Menlo Park, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4520']
540,31828291,"Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled Trial.","BACKGROUND


Enhanced influenza vaccines may improve protection for older adults, but comparative immunogenicity data are limited. Our objective was to examine immune responses to enhanced influenza vaccines, compared to standard-dose vaccines, in community-dwelling older adults.
METHODS


Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine. Sera collected from 200 recipients of each vaccine before and at 30-days postvaccination were assessed for antibodies to egg-propagated vaccine strains by hemagglutination inhibition (HAI) and to cell-propagated A/Hong Kong/4801/2014(H3N2) virus by microneutralization (MN). Influenza-specific CD4+ and CD8+ T cell responses were assessed in 20 participants per group.
RESULTS


Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2) and the MFR in MN to cell-propagated A(H3N2) were statistically significantly higher in the enhanced vaccine groups, compared to the standard-dose vaccine. The MFR in MN to cell-propagated A(H3N2) was highest among rHA recipients (4.7), followed by high-dose (3.4) and MF59-adjuvanted (2.9) recipients, compared to standard-dose recipients (2.3). Similarly, the ratio of postvaccination MN titers among rHA recipients to cell-propagated A(H3N2) recipients was 2.57-fold higher than the standard-dose vaccine, which was statistically higher than the high-dose (1.33-fold) and MF59-adjuvanted (1.43-fold) recipient ratios. Enhanced vaccines also resulted in the boosting of T-cell responses.
CONCLUSIONS


In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
CLINICAL TRIALS REGISTRATION


NCT03330132.",2020,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
","['older adults', '20 participants per group', 'community-dwelling older adults', 'Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a', 'Older Adults']","['standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine', 'Several Enhanced Influenza Vaccine Options']","['humoral and cell-mediated immune responses', 'Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2', 'Influenza-specific CD4+ and CD8+ T cell responses', 'ratio of postvaccination MN titers']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",200.0,0.0565966,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Ranawaka A P M', 'Initials': 'RAPM', 'LastName': 'Perera', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Valkenburg', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Yat Hung', 'Initials': 'YH', 'LastName': 'Tam', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Jennifer H F', 'Initials': 'JHF', 'LastName': 'Wong', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Athena P Y', 'Initials': 'APY', 'LastName': 'Li', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Hau Chi', 'Initials': 'HC', 'LastName': 'So', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Azziz-Baumgartner', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Fry', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Shivaprakash', 'Initials': 'S', 'LastName': 'Gangappa', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Suryaprakash', 'Initials': 'S', 'LastName': 'Sambhara', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Barr', 'Affiliation': 'World Health Organization Collaborating Centre for Reference and Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'British Columbia Centre for Disease Control, Vancouver, Canada.'}, {'ForeName': 'J S Malik', 'Initials': 'JSM', 'LastName': 'Peiris', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1034']
541,31898880,Multicenter Ozone Study in oldEr Subjects (MOSES): Part 1. Effects of Exposure to Low Concentrations of Ozone on Respiratory and Cardiovascular Outcomes.,"INTRODUCTION


Exposure to air pollution is a well-established risk factor for cardiovascular morbidity and mortality. Most of the evidence supporting an association between air pollution and adverse cardiovascular effects involves exposure to particulate matter (PM). To date, little attention has been paid to acute cardiovascular responses to ozone, in part due to the notion that ozone causes primarily local effects on lung function, which are the basis for the current ozone National Ambient Air Quality Standards (NAAQS). There is evidence from a few epidemiological studies of adverse health effects of chronic exposure to ambient ozone, including increased risk of mortality from cardiovascular disease. However, in contrast to the well-established association between ambient ozone and various nonfatal adverse respiratory effects, the observational evidence for impacts of acute (previous few days) increases in ambient ozone levels on total cardiovascular mortality and morbidity is mixed.
Ozone is a prototypic oxidant gas that reacts with constituents of the respiratory tract lining fluid to generate reactive oxygen species (ROS) that can overwhelm antioxidant defenses and cause local oxidative stress. Pathways by which ozone could cause cardiovascular dysfunction include alterations in autonomic balance, systemic inflammation, and oxidative stress. These initial responses could lead ultimately to arrhythmias, endothelial dysfunction, acute arterial vasoconstriction, and procoagulant activity. Individuals with impaired antioxidant defenses, such as those with the null variant of glutathione S-transferase mu 1 (GSTM1), may be at increased risk for acute health effects.
The Multicenter Ozone Study in oldEr Subjects (MOSES) was a controlled human exposure study designed to evaluate whether short-term exposure of older, healthy individuals to ambient levels of ozone induces acute cardiovascular responses. The study was designed to test the a priori hypothesis that short-term exposure to ambient levels of ozone would induce acute cardiovascular responses through the following mechanisms: autonomic imbalance, systemic inflammation, and development of a prothrombotic vascular state. We also postulated a priori the confirmatory hypothesis that exposure to ozone would induce airway inflammation, lung injury, and lung function decrements. Finally, we postulated the secondary hypotheses that ozone-induced acute cardiovascular responses would be associated with: (a) increased systemic oxidative stress and lung effects, and (b) the GSTM1-null genotype.
METHODS


The study was conducted at three clinical centers with a separate Data Coordinating and Analysis Center (DCAC) using a common protocol. All procedures were approved by the institutional review boards (IRBs) of the participating centers. Healthy volunteers 55 to 70 years of age were recruited. Consented participants who successfully completed the screening and training sessions were enrolled in the study. All three clinical centers adhered to common standard operating procedures (SOPs) and used common tracking and data forms. Each subject was scheduled to participate in a total of 11 visits: screening visit, training visit, and three sets of exposure visits, each consisting of the pre-exposure day, the exposure day, and the post-exposure day. The subjects spent the night in a nearby hotel the night of the pre-exposure day.
On exposure days, the subjects were exposed for three hours in random order to 0 ppb ozone (clean air), 70 ppb ozone, and 120 ppm ozone, alternating 15 minutes of moderate exercise with 15 minutes of rest. A suite of cardiovascular and pulmonary endpoints was measured on the day before, the day of, and up to 22 hours after, each exposure. The endpoints included: (1) electrocardiographic changes (continuous Holter monitoring: heart rate variability [HRV], repolarization, and arrhythmia); (2) markers of inflammation and oxidative stress (C-reactive protein [CRP], interleukin-6 [IL-6], 8-isoprostane, nitrotyrosine, and P-selectin); (3) vascular function measures (blood pressure [BP], flow-mediated dilatation [FMD] of the brachial artery, and endothelin-1 [ET-1]; (4) venous blood markers of platelet activation, thrombosis, and microparticle-associated tissue factor activity (MP-TFA); (5) pulmonary function (spirometry); (6) markers of airway epithelial cell injury (increases in plasma club cell protein 16 [CC16] and sputum total protein); and (7) markers of lung inflammation in sputum (polymorphonuclear leukocytes [PMN], IL-6, interleukin-8 [IL-8], and tumor necrosis factor-alpha [TNF-α]). Sputum was collected only at 22 hours after exposure.
The analyses of the continuous electrocardiographic monitoring, the brachial artery ultrasound (BAU) images, and the blood and sputum samples were carried out by core laboratories. The results of all analyses were submitted directly to the DCAC.
The variables analyzed in the statistical models were represented as changes from pre-exposure to post-exposure (post-exposure minus pre-exposure). Mixed-effect linear models were used to evaluate the impact of exposure to ozone on the prespecified primary and secondary continuous outcomes. Site and time (when multiple measurements were taken) were controlled for in the models. Three separate interaction models were constructed for each outcome: ozone concentration by subject sex; ozone concentration by subject age; and ozone concentration by subject GSTM1 status (null or sufficient). Because of the issue of multiple comparisons, the statistical significance threshold was set a priori at  P  < 0.01.
RESULTS


Subject recruitment started in June 2012, and the first subject was randomized on July 25, 2012. Subject recruitment ended on December 31, 2014, and testing of all subjects was completed by April 30, 2015. A total of 87 subjects completed all three exposures. The mean age was 59.9 ± 4.5 years, 60% of the subjects were female, 88% were white, and 57% were GSTM1 null. Mean baseline body mass index (BMI), BP, cholesterol (total and low-density lipoprotein), and lung function were all within the normal range.
We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia. Ozone exposure also did not cause significant changes in the primary endpoints for systemic inflammation (CRP) and vascular function (systolic blood pressure [SBP] and FMD) or secondary endpoints for systemic inflammation and oxidative stress (IL-6, P-selectin, and 8-isoprostane). Ozone did cause changes in two secondary endpoints: a significant increase in plasma ET-1 ( P  = 0.008) and a marginally significant decrease in nitrotyrosine ( P  = 0.017). Lastly, ozone exposure did not affect the primary prothrombotic endpoints (MP-TFA and monocyte-platelet conjugate count) or any secondary markers of prothrombotic vascular status (platelet activation, circulating microparticles [MPs], von Willebrand factor [vWF], or fibrinogen.).
Although our hypothesis focused on possible acute cardiovascular effects of exposure to low levels of ozone, we recognized that the initial effects of inhaled ozone involve the lower airways. Therefore, we looked for: (a) changes in lung function, which are known to occur during exposure to ozone and are maximal at the end of exposure; and (b) markers of airway injury and inflammation. We found an increase in forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV₁) after exposure to 0 ppb ozone, likely due to the effects of exercise. The FEV₁ increased significantly 15 minutes after 0 ppb exposure (85 mL; 95% confidence interval [CI], 64 to 106;  P  < 0.001), and remained significantly increased from pre-exposure at 22 hours (45 mL; 95% CI, 26 to 64;  P  < 0.001). The increase in FVC followed a similar pattern. The increase in FEV₁ and FVC were attenuated in a dose-response manner by exposure to 70 and 120 ppb ozone. We also observed a significant ozone-induced increase in the percentage of sputum PMN 22 hours after exposure at 120 ppb compared to 0 ppb exposure ( P  = 0.003). Plasma CC16 also increased significantly after exposure to 120 ppb ( P  < 0.001). Sputum IL-6, IL-8, and TNF-α concentrations were not significantly different after ozone exposure. We found no significant interactions with sex, age, or GSTM1 status regarding the effect of ozone on lung function, percentage of sputum PMN, or plasma CC16.
CONCLUSIONS


In this multicenter clinical study of older healthy subjects, ozone exposure caused concentration-related reductions in lung function and presented evidence for airway inflammation and injury. However, there was no convincing evidence for effects on cardiovascular function. Blood levels of the potent vasoconstrictor, ET-1, increased with ozone exposure (with marginal statistical significance), but there were no effects on BP, FMD, or other markers of vascular function. Blood levels of nitrotyrosine decreased with ozone exposure, the opposite of our hypothesis. Our study does not support acute cardiovascular effects of low-level ozone exposure in healthy older subjects. Inclusion of only healthy older individuals is a major limitation, which may affect the generalizability of our findings. We cannot exclude the possibility of effects with higher ozone exposure concentrations or more prolonged exposure, or the possibility that subjects with underlying vascular disease, such as hypertension or diabetes, would show effects under these conditions.",2017,"We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia.","['healthy older individuals', 'healthy older subjects', 'The mean age was 59.9 ± 4.5\xa0years, 60% of the subjects were female, 88% were white, and 57% were GSTM1 null', 'Healthy volunteers 55 to 70\xa0years of age were recruited', 'three clinical centers with a separate Data Coordinating and Analysis Center (DCAC) using a common protocol', 'Consented participants who successfully completed the screening and training sessions were enrolled in the study', 'oldEr Subjects (MOSES', 'A total of 87\xa0subjects completed all three exposures', 'older healthy subjects']","['ppb ozone (clean air), 70\xa0ppb ozone, and 120\xa0ppm ozone, alternating 15\xa0minutes of moderate exercise with 15\xa0minutes of rest']","['Mean baseline body mass index (BMI), BP, cholesterol (total and low-density lipoprotein), and lung function', 'FEV₁ and FVC', 'autonomic function, repolarization, ST segment change, or arrhythmia', 'total cardiovascular mortality and morbidity', 'systemic inflammation (CRP) and vascular function (systolic blood pressure [SBP] and FMD) or secondary endpoints for systemic inflammation and oxidative stress (IL-6, P-selectin, and 8-isoprostane', 'cardiovascular function', 'Blood levels of nitrotyrosine', 'FEV₁', 'BP, FMD, or other markers of vascular function', 'arrhythmias, endothelial dysfunction, acute arterial vasoconstriction, and procoagulant activity', 'Plasma CC16', 'forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV₁', 'primary prothrombotic endpoints (MP-TFA and monocyte-platelet conjugate count) or any secondary markers of prothrombotic vascular status (platelet activation, circulating microparticles [MPs], von Willebrand factor [vWF], or fibrinogen', 'Respiratory and Cardiovascular Outcomes', 'lung function, percentage of sputum PMN, or plasma CC16', 'electrocardiographic changes (continuous Holter monitoring: heart rate variability [HRV], repolarization, and arrhythmia); (2)\xa0markers of inflammation and oxidative stress (C-reactive protein [CRP], interleukin-6 [IL-6], 8-isoprostane, nitrotyrosine, and P-selectin); (3)\xa0vascular function measures (blood pressure [BP], flow-mediated dilatation [FMD] of the brachial artery, and endothelin-1 [ET-1]; (4)\xa0venous blood markers of platelet activation, thrombosis, and microparticle-associated tissue factor activity (MP-TFA); (5)\xa0pulmonary function (spirometry); (6)\xa0markers of airway epithelial cell injury (increases in plasma club cell protein 16 [CC16] and sputum total protein); and (7)\xa0markers of lung inflammation in sputum (polymorphonuclear leukocytes [PMN], IL-6, interleukin-8 [IL-8], and tumor necrosis factor-alpha [TNF-α', 'Blood levels', 'systemic oxidative stress and lung effects', 'percentage of sputum PMN', 'FVC', 'Sputum IL-6, IL-8, and TNF-α concentrations', 'nitrotyrosine', 'plasma ET-1']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032441', 'cui_str': 'Polybromobiphenyl Compounds'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0040048', 'cui_str': 'Prothrombinase'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0472837,"We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia.","[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Frampton', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Balmes', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Bromberg', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stark', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arjomandi', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hazucha', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'D Q', 'Initials': 'DQ', 'LastName': 'Rich', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Alexis', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ganz', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Costantini', 'Affiliation': 'Health Effects Institute, Boston, Massachusetts.'}]",Research report (Health Effects Institute),[]
542,31892475,Admitting women in active labour: A randomised controlled trial about the effects of protocol use on childbirth method and interventions.,"AIM


To determine the effects of protocol of admitting women in active labour on childbirth method and interventions during labour and childbirth.
METHODS


This single-blind randomised clinical trial was conducted in a public hospital in Mazandaran province (Iran) in 2017. Two hundred nulliparous low-risk women were randomly assigned into intervention and control groups. The participant women were admitted in the intervention group using the admission protocol and to the group control by staff midwives and doctors. The admission criteria of the protocol were: the presence of regular, painful contractions, the cervix at least four cm dilated and at least one of the following cues: cervix effaced, and spontaneous rupture of membranes, or ""show"". The primary outcome measure was childbirth method. Data were analyzed in SPSS-22 using Mann-Whitney and Chi-square tests. The level of statistical significance was set as p<0.05.
FINDING


There were significant differences between the intervention and control groups in the number of caesarian section (CS) (p<0.001). Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
CONCLUSIONS


Using a protocol for admission of low risk nulliparous women in active labour contributed to reduction of the primary caesarean section rate and interventions during childbirth. A risk assessment and using evidence informed guidelines in admission can contribute to reduce unsafe and harmful practices and support normalisation of birth. This is essential for demedicalisation and a useful strategy for reducing primary CS.",2020,"Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
","['participant women were admitted in the intervention group using the admission protocol and to the group control by staff midwives and doctors', 'Admitting women in active labour', 'public hospital in Mazandaran province (Iran) in 2017', 'Two hundred nulliparous low-risk women', 'low risk nulliparous women in active labour contributed to reduction of the primary caesarean section rate and interventions during childbirth', 'admitting women in active labour on childbirth method and interventions during labour and childbirth']",[],"['childbirth method', 'augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001', 'number of caesarian section (CS', 'amniotomy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0401993', 'cui_str': 'Staff midwife (occupation)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]",[],"[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0200048', 'cui_str': 'Vaginal Exam'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1384591', 'cui_str': 'Amniotomy'}]",200.0,0.166402,"Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
","[{'ForeName': 'Freshteh', 'Initials': 'F', 'LastName': 'Abasian Kasegari', 'Affiliation': 'School of Nursing and Midwifery Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Pazandeh', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Centre, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: pazandehf@gmail.com.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Darvish', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Huss', 'Affiliation': 'Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'School of Nursing and Midwifery Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2019.12.002']
543,30963440,Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.,"BACKGROUND


African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.
RESEARCH DESIGN AND METHODS


This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.
RESULTS


At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.
CONCLUSIONS


The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
NIH TRIAL REGISTRY NUMBER


NCT01901952.",2019,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
","['Urban Low-Income African Americans with Type 2 Diabetes', 'African Americans', 'African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME', 'low-income African-American patients of public hospital clinics']","['Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes', 'Lifestyle Intervention', 'LIFE intervention', 'DSME intervention']","['diet quality', 'medication adherence', 'nutrition knowledge', 'nutrition knowledge and diet quality', 'changes in hemoglobin A1c (A1c']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.0685125,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.
","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Lynch', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA. Elizabeth_lynch@rush.edu.'}, {'ForeName': 'Laurin', 'Initials': 'L', 'LastName': 'Mack', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dawar', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'DeJuran', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Appelhans', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Tahsin', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fogelfeld', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04894-y']
544,31970939,"Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC-302 in Healthy Participants: Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Dose Studies.","TAC-302 stimulates neurite outgrowth activity and is expected to restore urinary function in patients with lower urinary tract dysfunction. We conducted 2 phase 1, randomized, placebo-controlled studies to confirm the safety and pharmacokinetics (PK) of TAC-302 in healthy adult Japanese male volunteers. In the first-in-human single-dose study (n = 60), TAC-302 was administered at doses from 100 to 1200 mg after an overnight fast. The effects of a meal on the PK of TAC-302 400 mg were also examined. A multiple-dose study (n = 36) evaluated the effects of meal fat content on the PK of single doses of TAC-302 (100, 200, or 400 mg) and multiple doses of TAC-302 administered for 5 days (100, 200, and 400 mg twice daily). TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state. No accumulation of TAC-302 was observed. Food, particularly with high fat content, increased TAC-302 plasma concentrations. No differences were observed in the adverse event incidence between the TAC-302 and placebo groups in either study. TAC-302 showed a wide safety margin.",2020,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","['healthy adult Japanese male volunteers', 'Healthy Participants', 'patients with lower urinary tract dysfunction']","['Placebo', 'placebo', 'TAC-302']","['Safety, Tolerability, Pharmacokinetics, and Food Effects', 'adverse event incidence', 'TAC-302 plasma concentrations', 'safety and pharmacokinetics (PK', 'accumulation of TAC-302']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0894403,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sesoko', 'Affiliation': 'Sosenkai Clinic Edogawa, Mizue, Edogawa-ku, Tokyo, Japan.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Pharmacovigilance Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Takashige', 'Initials': 'T', 'LastName': 'Okayama', 'Affiliation': 'Pharmacokinetics Research Laboratories, Taiho Pharmaceutical Co., Ltd., Okubo, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nishida', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyoshi', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.776']
545,31791333,Effect of vitamin D fortified foods on bone markers and muscle strength in women of Pakistani and Danish origin living in Denmark: a randomised controlled trial.,"BACKGROUND


Deficient and insufficient vitamin D status (defined as serum 25(OH)D < 30 nmol/L and > 50 nmol/L) is prevalent worldwide and associated with decreased muscle strength and poor bone health. We aimed to investigate the effect of vitamin D fortification on bone markers and muscle strength among younger adult women at risk of vitamin D deficiency.
METHODS


A 12-week randomised double-blinded placebo-controlled winter intervention trial, providing 30 μg vitamin D 3 /day through fortified yoghurt, cheese, eggs and crisp-bread or similar placebo products. Participants were 143 women of Danish and Pakistani origin 18-50 years of age, living in Denmark, randomised into four groups stratified by ethnicity. Serum 25-hydroxyvitamin D (25(OH)D) by LC-MS/MS and the secondary endpoints: four specific bone markers (osteocalcin (OC), Bone specific Alkaline Phosphatase (BALP), Procollagen type 1 amino-terminal propeptide (P1NP), C-terminal crosslinked telopeptide of type 1 collagen (CTX)) and three muscle strength measures (handgrip, knee extension strength, chair-standing), were assessed using one-way ANOVA, Tukey HSD and subsequent linear ANCOVA models, adjusted for relevant covariates.
RESULTS


Significantly increased serum 25(OH)D concentration from 53.3 (17) to 77.8 (14) nmol/L and from 44.5 (21) to 54.7 (18) nmol/L among Danish and Pakistani women in the fortified groups, respectively (P <  0.05). The bone turnover markers OC, BALP, P1NP and CTX did not change significantly. Muscle strength by handgrip, knee extension and chair-standing test did not change significantly following the intervention.
CONCLUSIONS


Consumption of vitamin D fortified foods for 12 weeks did not result in significant changes of the bone turnover markers OC, BALP, P1NP and CTX. Muscle strength measured as hand grip strength, knee extension strength and chair-standing did not change significantly following the intervention.",2019,"The bone turnover markers OC, BALP, P1NP and CTX did not change significantly.","['women of Pakistani and Danish origin living in Denmark', 'younger adult women at risk of vitamin D deficiency', 'Participants were 143 women of Danish and Pakistani origin 18-50\u2009years of age, living in Denmark']","['placebo', 'vitamin D fortification', '30\u2009μg vitamin D 3 /day through fortified yoghurt, cheese, eggs and crisp-bread or similar placebo products', 'vitamin D fortified foods']","['Serum 25-hydroxyvitamin D (25(OH)D', 'bone turnover markers OC, BALP, P1NP and CTX', ' C-terminal crosslinked telopeptide of type 1 collagen (CTX)) and three muscle strength measures (handgrip, knee extension strength, chair-standing', 'Muscle strength by handgrip, knee extension and chair-standing test', 'serum 25(OH)D concentration', 'Muscle strength measured as hand grip strength, knee extension strength and chair-standing', 'bone markers and muscle strength', 'specific bone markers (osteocalcin (OC), Bone specific Alkaline Phosphatase (BALP), Procollagen type 1 amino-terminal propeptide (P1NP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0016498', 'cui_str': 'Enriched Food'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]",143.0,0.235282,"The bone turnover markers OC, BALP, P1NP and CTX did not change significantly.","[{'ForeName': 'Ida M', 'Initials': 'IM', 'LastName': 'Grønborg', 'Affiliation': 'National Food Institute, Technical University of Denmark, Lyngby, Denmark. idamag@food.dtu.dk.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Tetens', 'Affiliation': 'National Food Institute, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Elisabeth Wreford', 'Initials': 'EW', 'LastName': 'Andersen', 'Affiliation': 'Section for Statistics and Pharmacoepidemiology, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kristensen', 'Affiliation': 'Department of Nursing and Nutrition, Faculty of Health, University College Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke E K', 'Initials': 'REK', 'LastName': 'Larsen', 'Affiliation': 'Department of Nursing and Nutrition, Faculty of Health, University College Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thanh L L', 'Initials': 'TLL', 'LastName': 'Tran', 'Affiliation': 'Department of Nursing and Nutrition, Faculty of Health, University College Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Andersen', 'Affiliation': 'National Food Institute, Technical University of Denmark, Lyngby, Denmark.'}]",Nutrition journal,['10.1186/s12937-019-0504-9']
546,31950604,"Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial.","AIMS


Asymptomatic patients with coronary artery disease (CAD), hypertension and/or type 2 diabetes mellitus (T2DM) are at greater risk of developing heart failure (HF). Fibrosis, leading to myocardial and vascular dysfunction, might be an important pathway of progression. The Heart OMics in AGing (HOMAGE) trial aims to investigate the effects of spironolactone on serum markers of collagen metabolism and on cardiovascular structure and function in people at risk of developing HF and potential interactions with a marker of fibrogenic activity, galectin-3.
METHODS AND RESULTS


The HOMAGE trial is a prospective, randomised, open-label, blinded endpoint (PROBE) study comparing spironolactone (up to 50 mg/day) and standard care over 9 months in people with clinical risk factors for developing HF, including hypertension, CAD and T2DM, and elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP, 125 to 1000 ng/L) or B-type natriuretic peptide (BNP, 35 to 280 ng/L). Exclusion criteria included left ventricular ejection fraction < 45%, atrial fibrillation, severe renal dysfunction, or treatment with loop diuretics. The primary endpoint was the interaction between change in serum concentrations of procollagen type III N-terminal propeptide (PIIINP) and treatment with spironolactone according to median plasma concentrations of galectin-3 at baseline. For the 527 participants enrolled, median (interquartile range) age was 73 (69-79) years, 135 (26%) were women, 412 (78%) had hypertension, 377 (72%) CAD, and 212 (40%) T2DM. At baseline, medians (interquartile ranges) were for left ventricular ejection fraction 63 (58-67) %, for left atrial volume index 31 (26-37) mL/m 2  , for plasma NT-proBNP 214 (137-356) ng/L, for serum PIIINP 3.9 (3.1-5.0) ng/mL, and for galectin-3 16.1 (13.5-19.7) ng/mL.
CONCLUSIONS


The HOMAGE trial will provide insights on the effect of spironolactone on pathways that might drive progression to HF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02556450.",2020,"At baseline, medians (interquartile ranges) were for left ventricular ejection fraction 63 (58-67) %, for left atrial volume index 31 (26-37) mL/m 2  , for plasma NT-proBNP 214 (137-356) ng/L, for serum PIIINP 3.9 (3.1-5.0) ng/mL, and for galectin-3 16.1","['people at high risk of developing heart failure', 'Asymptomatic patients with coronary artery disease (CAD), hypertension and/or type 2 diabetes mellitus (T2DM', 'Exclusion criteria included left ventricular ejection fraction <\u200945%, atrial fibrillation, severe renal dysfunction, or treatment with loop diuretics', '527 participants enrolled, median (interquartile range) age was 73 (69-79) years, 135 (26%) were women, 412 (78%) had hypertension, 377 (72%) CAD, and 212 (40%) T2DM']",['spironolactone'],"['serum concentrations of procollagen type III N-terminal propeptide (PIIINP', 'median plasma concentrations of galectin-3 at baseline', 'serum markers of fibrosis']","[{'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0072054', 'cui_str': 'PCP III'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0245382', 'cui_str': 'CBP-30'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",527.0,0.273641,"At baseline, medians (interquartile ranges) were for left ventricular ejection fraction 63 (58-67) %, for left atrial volume index 31 (26-37) mL/m 2  , for plasma NT-proBNP 214 (137-356) ng/L, for serum PIIINP 3.9 (3.1-5.0) ng/mL, and for galectin-3 16.1","[{'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy,Institut Lorrain du Coeur et des Vaisseaux, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Mariottoni', 'Affiliation': 'Department of Cardiology, Cortona Hospital, Arezzo, Italy.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Fozia Z', 'Initials': 'FZ', 'LastName': 'Ahmed', 'Affiliation': 'Manchester Heart Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre, Manchester, UK.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Verdonschot', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Joe J', 'Initials': 'JJ', 'LastName': 'Cuthbert', 'Affiliation': 'Department of Academic Cardiology, Castle Hill Hospital, Hull York Medical School (at University of Hull), Kingston upon Hull, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petutschnigg', 'Affiliation': 'Department of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Blerim', 'Initials': 'B', 'LastName': 'Mujaj', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy,Institut Lorrain du Coeur et des Vaisseaux, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Program of Cardiovascular Diseases, CIMA Universidad de Navarra and IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Department of Academic Cardiology, Castle Hill Hospital, Hull York Medical School (at University of Hull), Kingston upon Hull, UK.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cosmi', 'Affiliation': 'Department of Cardiology, Cortona Hospital, Arezzo, Italy.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Staessen', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heymans', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy,Institut Lorrain du Coeur et des Vaisseaux, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy,Institut Lorrain du Coeur et des Vaisseaux, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}]",European journal of heart failure,['10.1002/ejhf.1716']
547,30969032,Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men.,"BACKGROUND


Novel male-based contraceptives are needed to broaden family planning choices. A progestin, Nestorone ®  (Nes) gel, plus a testosterone (T) gel suppresses sperm concentrations to levels associated with effective contraception in normal men. However, administration of two gels on different parts of the body daily is impractical.
OBJECTIVE


Compare the effectiveness of daily application of a single, combined 8.3 mg Nes-62.5 mg T gel (Nes-T) vs. 62.7 mg T gel to suppress serum FSH and LH concentrations to ≤1.0 IU/L (a threshold associated with suppression of sperm concentrations to ≤1 million and effective contraception) and to compare the pharmacokinetics of serum Nes and T concentrations between the gel groups.
DESIGN


We conducted a 28-day, double-blind, controlled trial of 44 healthy men randomized to daily Nes-T or T gel with measurement of hormones at baseline, treatment, and recovery and during 24-h pharmacokinetic studies on days 1 and 28 of treatment.
RESULTS


Of the subjects who met pre-defined inclusion criteria, 84% of the Nes-T group suppressed serum gonadotropin concentrations to ≤1.0 IU/L at days 21-28 vs. 16.7% in the T group (p < 0.001). On day 1, Nes concentrations rose significantly above baseline by 2 h and continued to rise up to 24 h after Nes-T gel application. Nes concentrations were not detectable in the T group. Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01). There were no serious adverse events in either group. About 80% of the subjects reported satisfaction with both gels.
CONCLUSION


Daily Nes-T gel effectively and safely suppresses serum gonadotropins and is acceptable to most men. It should be studied further in efficacy trials of hormonal male contraception.",2019,"Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01).","['men', '44 healthy men randomized to', 'normal men']","['progestin, Nestorone ®  (Nes) gel, plus a testosterone (T) gel', 'Combined nestorone-testosterone gel', 'daily Nes-T or T gel']","['Nes and T concentrations', 'serum FSH and LH concentrations', 'Nes concentrations', 'Serum total T concentrations', 'serum gonadotropin concentrations', 'serious adverse events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0283986', 'cui_str': 'Nestorone'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0605677,"Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01).","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ceponis', 'Affiliation': 'Institute of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Surampudi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dart', 'Affiliation': 'Health Decisions, Durham, NC, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}]",Andrology,['10.1111/andr.12603']
548,31919540,Increased leg muscle fatigability during 2 mA and 4 mA transcranial direct current stimulation over the left motor cortex.,"Transcranial direct current stimulation (tDCS) using intensities ≤ 2 mA on physical and cognitive outcomes has been extensively investigated. Studies comparing the effects of different intensities of tDCS have yielded mixed results and little is known about how higher intensities (> 2 mA) affect outcomes. This study examined the effects of tDCS at 2 mA and 4 mA on leg muscle fatigability. This was a double-blind, randomized, sham-controlled study. Sixteen healthy young adults underwent tDCS at three randomly ordered intensities (sham, 2 mA, 4 mA). Leg muscle fatigability of both legs was assessed via isokinetic fatigue testing (40 maximal reps, 120°/s). Torque- and work-derived fatigue indices (FI-T and FI-W, respectively), as well as total work performed (TW), were calculated. FI-T of the right knee extensors indicated increased fatigability in 2 mA and 4 mA compared with sham (p = 0.01, d = 0.73 and p < 0.001, d = 1.61, respectively). FI-W of the right knee extensors also indicated increased fatigability in 2 mA and 4 mA compared to sham (p = 0.01, d = 0.57 and p < 0.001, d = 1.12, respectively) and 4 mA compared with 2 mA (p = 0.034, d = 0.37). tDCS intensity did not affect TW performed. The 2 mA and 4 mA tDCS intensities increased the fatigability of the right knee extensors in young, healthy participants, potentially from altered motor unit recruitment/discharge rate or cortical hyperexcitability. Despite this increase in fatigability, the TW performed in both these conditions was not different from sham.",2020,"The 2 mA and 4 mA tDCS intensities increased the fatigability of the right knee extensors in young, healthy participants, potentially from altered motor unit recruitment/discharge rate or cortical hyperexcitability.",['Sixteen healthy young adults underwent'],"['Transcranial direct current stimulation (tDCS', 'tDCS']","['tDCS intensity', 'fatigability', 'fatigability of the right knee extensors', 'leg muscle fatigability', 'Increased leg muscle fatigability', 'Torque- and work-derived fatigue indices']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C4281598', 'cui_str': 'Right knee'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",16.0,0.063566,"The 2 mA and 4 mA tDCS intensities increased the fatigability of the right knee extensors in young, healthy participants, potentially from altered motor unit recruitment/discharge rate or cortical hyperexcitability.","[{'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Workman', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, E432 Field House, Iowa City, IA, 52242, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kamholz', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Rudroff', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, E432 Field House, Iowa City, IA, 52242, USA. thorsten-rudroff@uiowa.edu.'}]",Experimental brain research,['10.1007/s00221-019-05721-w']
549,31819920,Use and Patient-Reported Outcomes of Clinical Multigene Panel Testing for Cancer Susceptibility in the Multicenter Communication of Genetic Test Results by Telephone Study.,"Purpose


Multigene panels (MGPs) are increasingly being used despite questions regarding their clinical utility and no standard approach to genetic counseling. How frequently genetic providers use MGP testing and how patient-reported outcomes (PROs) differ from targeted testing (eg,  BRCA1/2  only) are unknown.
Methods


We evaluated use of MGP testing and PROs in participants undergoing cancer genetic testing in the multicenter Communication of Genetic Test Results by Telephone study (ClinicalTrials.gov identifier: ), a randomized study of telephone versus in-person disclosure of genetic test results. PROs included genetic knowledge, general and state anxiety, depression, cancer-specific distress, uncertainty, and satisfaction. Genetic providers offered targeted or MGP testing based on clinical assessment.
Results


Since the inclusion of MGP testing in 2014, 395 patients (66%) were offered MGP testing. MGP testing increased over time from 57% in 2014 to 66% in 2015 ( P  = .02) and varied by site (46% to 78%;  P  < .01). Being offered MGP testing was significantly associated with not having Ashkenazi Jewish ancestry, having a history of cancer, not having a mutation in the family, not having made a treatment decision, and study site. After demographic adjustment, patients offered MGP testing had lower general anxiety ( P  = .04), state anxiety ( P  = .03), depression ( P  = .04), and uncertainty ( P  = .05) pre-disclosure compared with patients offered targeted testing. State anxiety ( P  = .05) and cancer-specific distress ( P  = .05) were lower at disclosure in the MGP group. There was a greater increase in change in uncertainty ( P  = .04) among patients who underwent MGP testing.
Conclusion


MGP testing was more frequently offered to patients with lower anxiety, depression, and uncertainty and was associated with favorable outcomes, with the exception of a greater increase in uncertainty compared with patients who had targeted testing. Addressing uncertainty may be important as MGP testing is increasingly adopted.",2018,State anxiety ( P  = .05) and cancer-specific distress ( P  = .05) were lower at disclosure in the MGP group.,['participants undergoing cancer genetic testing in the multicenter Communication of Genetic Test Results by Telephone study (ClinicalTrials.gov identifier: '],"['telephone', 'MGP testing and PROs']","['cancer-specific distress', 'change in uncertainty', 'depression', 'genetic knowledge, general and state anxiety, depression, cancer-specific distress, uncertainty, and satisfaction', 'state anxiety', 'MGP testing increased over time', 'general anxiety', 'State anxiety']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",395.0,0.0278969,State anxiety ( P  = .05) and cancer-specific distress ( P  = .05) were lower at disclosure in the MGP group.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Patrick-Miller', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'The John H. Stroger Jr. Hospital of Cook County.'}, {'ForeName': 'Generosa', 'Initials': 'G', 'LastName': 'Grana', 'Affiliation': 'Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'Olufunmilayo I', 'Initials': 'OI', 'LastName': 'Olopade', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fetzer', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Dana F', 'Initials': 'DF', 'LastName': 'Clark', 'Affiliation': 'Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Gaber', 'Affiliation': 'The John H. Stroger Jr. Hospital of Cook County.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Gulden', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Horte', 'Affiliation': 'Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Long', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'The John H. Stroger Jr. Hospital of Cook County.'}, {'ForeName': 'Shreshtha', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattie', 'Affiliation': 'Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McKenna', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rainey', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rybak', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Savage', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seelaus', 'Affiliation': 'The John H. Stroger Jr. Hospital of Cook County.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stoll', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Stopfer', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Xinxin Shirley', 'Initials': 'XS', 'LastName': 'Yao', 'Affiliation': 'Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Bradbury', 'Affiliation': 'University of Pennsylvania.'}]",JCO precision oncology,['10.1200/PO.18.00199']
550,31859211,"Achieving Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging in Coronary Artery Disease Using 16-cm Wide Detector CT.","RATIONALE AND OBJECTIVES


To investigate the feasibility of ""one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function) in coronary artery disease using 16-cm wide detector CT, compared to conventional coronary CT angiography (CCTA).
MATERIALS AND METHODS


442 patients with suspected coronary artery disease were randomly divided into two groups. Patients in group A underwent ""one-stop"" CTP, whereas group B underwent conventional CCTA. Image quality of CT images was assessed. Radiation and contrast medium doses and scan time of the two groups were recorded. Group A was further divided into four subgroups according to the degree of coronary artery stenosis, for which transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF) were measured.
RESULTS


Scan time was 73.1 ± 7.3 (s) longer in group A than in group B with 11.7% reduction of radiation dose (p < 0.001) and no significant difference in image quality was noted. Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2  =36.98, p < 0.001) were observed among four subgroups. A negative correlation was found between the degree of coronary artery stenosis and TPR of the corresponding myocardial segments (r = -0.55, p < 0.001). Patients with moderate to severe arterial stenosis exhibited a decreased LVEF compared to those with normal coronary arteries (48.0% vs 56.5%, p < 0.001).
CONCLUSION


Compared to conventional CCTA, our new developed ""one-stop"" CTP may provide more comprehensive information on myocardial perfusion, coronary artery stenosis, and LV cardiac function with reduced radiation and contrast medium doses.",2020,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2  =36.98, p < 0.001) were observed among four subgroups.",['442 patients with suspected coronary artery disease'],"['conventional CCTA', 'Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging', 'conventional coronary CT angiography (CCTA', 'one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function', 'one-stop"" CTP']","['transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF', 'Scan time', 'degree of coronary artery stenosis and TPR of the corresponding myocardial segments', 'LVEF', 'minimum TPR', 'Image quality of CT images', 'image quality', 'severe arterial stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}]","[{'cui': 'C0522497', 'cui_str': 'Transmural (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038449', 'cui_str': 'Stricture of artery (disorder)'}]",442.0,0.02102,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2  =36.98, p < 0.001) were observed among four subgroups.","[{'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kaiyue', 'Initials': 'K', 'LastName': 'Diao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Sixian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Jinge', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Chunchao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yingkun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China. Electronic address: HX_lizhenlin@126.com.'}]",Academic radiology,['10.1016/j.acra.2019.11.018']
551,31296256,Baseline T cell dysfunction by single cell network profiling in metastatic breast cancer patients.,"BACKGROUND


We previously reported the results of a multicentric prospective randomized trial of chemo-refractory metastatic breast cancer patients testing the efficacy of two doses of TGFβ blockade during radiotherapy. Despite a lack of objective responses to the combination, patients who received a higher dose of TGFβ blocking antibody fresolimumab had a better overall survival when compared to those assigned to lower dose (hazard ratio of 2.73, p = 0.039). They also demonstrated an improved peripheral blood mononuclear cell (PBMC) counts and increase in the CD8 central memory pool. We performed additional analysis on residual PBMC using single cell network profiling (SCNP).
METHODS


The original trial randomized metastatic breast cancer patients to either 1 or 10 mg/kg of fresolimumab, every 3 weeks for 5 cycles, combined with radiotherapy to a metastatic site at week 1 and 7 (22.5 Gy given in 3 doses of 7.5 Gy). Trial immune monitoring results were previously reported. In 15 patients with available residual blood samples, additional functional studies were performed, and compared with data obtained in parallel from seven healthy female donors (HD): SCNP was applied to analyze T cell receptor (TCR) modulated signaling via CD3 and CD28 crosslinking and measurement of evoked phosphorylation of AKT and ERK in CD4 and CD8 T cell subsets defined by PD-1 expression.
RESULTS


At baseline, a significantly higher level of expression (p < 0.05) of PD-L1 was identified in patient monocytes compared to HD. TCR modulation revealed dysfunction of circulating T-cells in patient baseline samples as compared to HD, and this was more pronounced in PD-1 +  cells. Treatment with radiotherapy and fresolimumab did not resolve this dyfunctional signaling. However, in vitro PD-1 blockade enhanced TCR signaling in patient PD-1 +  T cells and not in PD-1 -  T cells or in PD-1 +  T cells from HD.
CONCLUSIONS


Functional T cell analysis suggests that baseline T cell functionality is hampered in metastatic breast cancer patients, at least in part mediated by the PD-1 signaling pathway. These preliminary data support the rationale for investigating the possible beneficial effects of adding PD-1 blockade to improve responses to TGFβ blockade and radiotherapy.
TRIAL REGISTRATION


NCT01401062 .",2019,"At baseline, a significantly higher level of expression (p < 0.05) of PD-L1 was identified in patient monocytes compared to HD.","['refractory metastatic breast cancer patients', 'metastatic breast cancer patients', '15 patients with available residual blood samples, additional functional studies']","['radiotherapy', 'radiotherapy and fresolimumab', 'TGFβ blockade during radiotherapy', '1 or 10\u2009mg/kg of fresolimumab']","['peripheral blood mononuclear cell (PBMC) counts', 'level of expression', 'overall survival', 'CD8 central memory pool', 'dysfunction of circulating T-cells']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C2987643', 'cui_str': 'fresolimumab'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",,0.176271,"At baseline, a significantly higher level of expression (p < 0.05) of PD-L1 was identified in patient monocytes compared to HD.","[{'ForeName': 'Silvia C', 'Initials': 'SC', 'LastName': 'Formenti', 'Affiliation': 'Department of Radiation Oncology, Weill Cornell Medicine, New York, NY, 10065, USA. formenti@med.cornell.edu.'}, {'ForeName': 'Rachael E', 'Initials': 'RE', 'LastName': 'Hawtin', 'Affiliation': 'Nodality, 170 Harbor Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Dixit', 'Affiliation': 'Nodality, 170 Harbor Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Evensen', 'Affiliation': 'Nodality, 170 Harbor Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation oncology, UCLA David Geffen School of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Judith D', 'Initials': 'JD', 'LastName': 'Goldberg', 'Affiliation': 'Department of Population Health and Environmental Medicine, New York University School of Medicine, New York, NY, 10016, USA.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Population Health and Environmental Medicine, New York University School of Medicine, New York, NY, 10016, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vanpouille-Box', 'Affiliation': 'Department of Radiation Oncology, Weill Cornell Medicine, New York, NY, 10065, USA.'}, {'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Schaue', 'Affiliation': 'Department of Radiation oncology, UCLA David Geffen School of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'McBride', 'Affiliation': 'Department of Radiation oncology, UCLA David Geffen School of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Demaria', 'Affiliation': 'Department of Radiation Oncology, Weill Cornell Medicine, New York, NY, 10065, USA. szd3005@med.cornell.edu.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0633-x']
552,31845139,"Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


No consensus has been achieved on optimal perioperative strategies for patients undergoing endoscopic submucosal dissection (ESD). The aim of this study was to investigate the effects of an intravenous (IV) proton pump inhibitor (PPI) given during the fasting period after ESD on delayed bleeding following ESD.
METHODS


This study was designed as a prospective, randomized, double-blind, placebo-controlled trial in a single center. A total of 235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018 were randomized into a PPI group and placebo group. Patients were administrated intravenous pantoprazole 40 mg daily (PPI group) or placebo (placebo group) during the fasting period 48 h after ESD (from the day of ESD to the following day, 48 h). After oral feeding (48 h after ESD), oral PPI was given to both groups for 8 weeks.
RESULTS


Among 235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis, there was no significant difference between the PPI and control groups in major bleeding (PPI vs. placebo; 3.3% vs. 1.7%, p = 0.27) or minor bleeding (PPI vs. placebo; 7.6% vs. 4.3%, p = 0.41) after ESD. There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups. The only independent risk factor for major delayed bleeding was the combined use of aspirin and antiplatelet agent (OR; 12.25, 95% CI; 1.06-141.19, p = 0.04).
CONCLUSIONS


Administration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding.",2020,"There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups.","['235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis', '235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018', 'patients undergoing endoscopic submucosal dissection (ESD']","['intravenous (IV) proton pump inhibitor (PPI', 'Placebo', 'Intravenous Proton Pump Inhibitor', 'PPI group and placebo', 'placebo', 'Endoscopic Submucosal Dissection', 'pantoprazole 40 mg daily (PPI group) or placebo (placebo', 'aspirin']","['tumor size', 'procedure time', 'minor bleeding', 'risk factor for major delayed bleeding', 'major bleeding', 'Bleeding Prevention', 'delayed post-ESD bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer (disorder)'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C1126048', 'cui_str': 'pantoprazole 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",235.0,0.377994,"There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups.","[{'ForeName': 'Jai Hoon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Youn Jeong', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious disease, Department of Internal medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Kang Nyeong', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, South Korea.'}, {'ForeName': 'Hang Lak', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. alwayshang@hanyang.ac.kr.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04466-9']
553,31883356,"Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure.","AIMS


Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF.
METHODS


AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
CONCLUSION


The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.",2019,"The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
","['1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100\u2009ng/mL or 100-299', 'patients hospitalised for acute HF (AHF', 'iron-deficient patients hospitalised for AHF', 'stable HF patients with reduced ejection fraction', 'iron-deficient patients admitted for acute heart failure']","['FCM or placebo', 'FCM (vs. placebo', 'FCM', 'ferric carboxymaltose (FCM', 'placebo', 'iron supplementation', 'intravenous ferric carboxymaltose']","['composite of recurrent HF hospitalisations and CV mortality', 'functional capacity, symptoms and quality of life', 'hospitalisations and mortality', 'composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes', 'recurrent HF hospitalisations and cardiovascular (CV) mortality', 'morbidity and mortality']","[{'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1100.0,0.73917,"The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dorobantu', 'Affiliation': 'Cardiology Department, Emergency Hospital of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Klinika Kardiologii, Uniwersytet Medyczny w Łodzi, Lodz, Poland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fabien', 'Affiliation': 'Vifor Pharma, Opfikon, Switzerland.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Heart Failure Unit, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Teba', 'Initials': 'T', 'LastName': 'Haboubi', 'Affiliation': 'Vifor Pharma, Opfikon, Switzerland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Keren', 'Affiliation': 'Assuta Hashalom Heart Institute, Assuta Hospitals, Tel-Aviv, Israel.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Khintibidze', 'Affiliation': 'Aleksandre Aladashvili Clinic, LLC, Tbilisi, Georgia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kragten', 'Affiliation': 'Molenberglaan, Heerlen, The Netherlands.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, International Society of Cardiovascular Pharmacotherapy, Córdoba, Argentina.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, University of Brescia and Civil Hospital, Brescia, Italy.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Faculdade de Medicina FMUSP, Instituto do Coracao (InCor), Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ohlsson', 'Affiliation': 'Department of Nephrology and Transplantation, Skane University Hospital Malmoe, Malmo, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parhomenko', 'Affiliation': 'The M.D. Strazhesko Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Hospital Virgen de la Arrixaca, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'UniversitätsSpietal Zürich, Klinik für Kardiologie, Zürich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre, Clinical Translational and Research Office, Singapore, Singapore.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Skouri', 'Affiliation': 'American University of Beirut, Medical Center Beirut, Beirut, Lebanon.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ewa A', 'Initials': 'EA', 'LastName': 'Jankowska', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wrocław, Poland.'}]",European journal of heart failure,['10.1002/ejhf.1710']
554,31860408,"Body Composition in Patients with Radioactive Iodine-Refractory, Advanced Differentiated Thyroid Cancer Treated with Sorafenib or Placebo: A Retrospective Analysis of the Phase III DECISION Trial.","Background:  Rates of adverse events with sorafenib were higher in the DECISION trial in radioactive iodine-refractory, advanced differentiated thyroid cancer (DTC) than in trials of sorafenib for other tumor types. One possible explanation is that sarcopenia, a known predictive factor of toxicity in patients with cancer, is more common in patients with DTC due to hormone suppressive therapy.  Methods:  This retrospective exploratory analysis was performed to assess whether the risk of early toxicity leading to dose modification (DMT) with sorafenib was higher in patients with sarcopenia compared with those without sarcopenia. The data set comprised patients from the phase III DECISION trial with a computed tomography scan available to determine muscle mass. The skeletal muscle (SM) cross-sectional area was used to determine the SM index and define sarcopenia. The end points were changes in body composition, DMT, early DMT (within 1 month), severe toxic events (STEs), and early STEs.  Results:  Overall, 365 patients were eligible for this analysis; baseline characteristics were well balanced between patients receiving sorafenib ( n  = 180) versus placebo ( n  = 185). Using a sarcopenia definition of an SM index less than the median sex-specific SM index, approximately half of the patients receiving sorafenib were at risk of sarcopenia (89/180; 49.4%), with wide geographical variation. At 6 months, the mean weight, body mass index, and lean body mass of patients receiving sorafenib were lower than at baseline and significantly lower than for patients receiving placebo (all  p  < 0.0001). Most DMTs and STEs occurred in the first month of treatment. There was a nonsignificant trend for more early DMTs in patients with sarcopenia compared with those without sarcopenia (55.3% vs. 44.7%, respectively;  p  = 0.2273).  Conclusions:  These results show a significant effect of sorafenib on muscle mass. However, there was no association between sarcopenia and DMT or early DMT, in contrast to observations in hepatocellular and renal cell carcinoma.",2019,"At 6 months, the mean weight, body mass index, and lean body mass of patients receiving sorafenib were lower than at baseline and significantly lower than for patients receiving placebo (all  p  < 0.0001).","['365 patients were eligible for this analysis; baseline characteristics were well balanced between patients receiving', 'patients with sarcopenia compared with those without sarcopenia', 'patients with cancer', 'patients with DTC due to hormone suppressive therapy', 'Patients with Radioactive Iodine-Refractory, Advanced Differentiated Thyroid Cancer Treated with']","['placebo', 'sorafenib', 'Sorafenib or Placebo']","['mean weight, body mass index, and lean body mass of patients receiving sorafenib', 'Body Composition', 'body composition, DMT, early DMT (within 1 month), severe toxic events (STEs), and early STEs', 'early DMTs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038340', 'cui_str': 'Stings'}]",365.0,0.159663,"At 6 months, the mean weight, body mass index, and lean body mass of patients receiving sorafenib were lower than at baseline and significantly lower than for patients receiving placebo (all  p  < 0.0001).","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huillard', 'Affiliation': 'Department of Medical Oncology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jouinot', 'Affiliation': 'Department of Medical Oncology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Tlemsani', 'Affiliation': 'Department of Medical Oncology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Abramson Cancer Center, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arrondeau', 'Affiliation': 'Department of Medical Oncology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Gerold', 'Initials': 'G', 'LastName': 'Meinhardt', 'Affiliation': 'Clinical Development Oncology; Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fellous', 'Affiliation': 'Pharmaceuticals Division; Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'De Sanctis', 'Affiliation': 'Integrated Analysis Statistics, Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schlumberger', 'Affiliation': 'Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Goldwasser', 'Affiliation': 'Department of Medical Oncology, Cochin Hospital, AP-HP, Paris, France.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2018.0784']
555,31309348,A Pilot Study of a Mobile App to Support HIV Antiretroviral Therapy Adherence Among Men Who Have Sex with Men Who Use Stimulants.,"APP+ is a theoretically-grounded mobile app intervention to improve antiretroviral (ART) adherence among men who have sex with men (MSM) who use stimulants. We assessed the feasibility and acceptability of APP+ in a six-month randomized controlled trial among a national sample of 90 MSM recruited online; secondarily, we examined changes in self-reported ART adherence by study arm. Retention at the final assessment was 82%, and acceptability ratings were comparable to other technology-based interventions. MSM in the APP+ group reported higher self-reported percentage ART adherence in the past 30 days at the four-month timepoint compared to a no-treatment control group (89.0% vs. 77.2%). However, once access to the app was removed after month four, group differences in ART adherence diminished by month six. APP+ may be a potentially promising intervention approach for MSM living with HIV who use stimulants but would require enhancements to optimize acceptability and demonstrate more sustained effects.",2019,MSM in the APP+ group reported higher self-reported percentage ART adherence in the past 30 days at the four-month timepoint compared to a no-treatment control group (89.0% vs. 77.2%).,"['Men', 'men who have sex with men (MSM) who use stimulants', 'Who Have Sex with Men']","['APP', 'Mobile App']","['ART adherence', 'feasibility and acceptability', 'acceptability ratings', 'antiretroviral (ART) adherence']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]",90.0,0.089356,MSM in the APP+ group reported higher self-reported percentage ART adherence in the past 30 days at the four-month timepoint compared to a no-treatment control group (89.0% vs. 77.2%).,"[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, USA. horva018@umn.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lammert', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'MacLehose', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, USA.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Danh', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, USA.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Division of Infectious Diseases, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'School of Medicine, University of Miami, Coral Gables, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02597-3']
556,31303261,Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training.,"BACKGROUND


The role of hippocampus in context-dependent recall of extinction is well recognized. However, little is known about how intervention-induced changes in hippocampal networks relate to improvements in extinction learning. In this study, we hypothesized that mindfulness training creates an optimal exposure condition by heightening attention and awareness of present moment sensory experience, leading to enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms.
METHODS


We tested this hypothesis in a randomized controlled longitudinal study design using a 2-day fear conditioning and extinction protocol. The mindfulness training group included 42 participants (28 women) and the control group included 25 participants (15 women).
RESULTS


We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization. We also report enhanced hippocampal connectivity to the primary sensory cortex during retrieval of extinguished stimuli following mindfulness training.
CONCLUSIONS


These findings suggest hippocampal-dependent changes in contextual retrieval as one plausible neural mechanism through which mindfulness-based interventions enhance fear extinction and foster stress resilience.",2019,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,['group included 42 participants (28 women) and the control group included 25 participants (15 women'],"['2-day fear conditioning and extinction protocol', 'mindfulness training']","['enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",42.0,0.0226357,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,"[{'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Sevinc', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: gsevinc@mgh.harvard.edu.'}, {'ForeName': 'Britta K', 'Initials': 'BK', 'LastName': 'Hölzel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Gard', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brunsch', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Javeria A', 'Initials': 'JA', 'LastName': 'Hashmi', 'Affiliation': 'Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Psychiatry Department, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.05.017']
557,31234642,Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial.,"BACKGROUND


Calcitonin gene-related peptide plays an important role in migraine pathophysiology. We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine.
OBJECTIVE


To determine the safety, tolerability, and effectiveness of four dose levels of eptinezumab and to inform the phase 3 development program.
METHODS


This was a phase 2b, parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial. Men and women (N = 616) aged 18-55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year. During the 28-day screening period, patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks as recorded in the electronic diary. Patients were assigned in a 1:1:1:1:1 ratio to eptinezumab 300, 100, 30, 10 mg or placebo, administered as a single IV infusion. The primary endpoint was the percentage of patients with a ≥75% decrease in monthly migraine days over weeks 1-12 compared with the 28-day screening period.
RESULTS


The ≥75% migraine responder rates over weeks 1-12 for eptinezumab 300, 100, 30, and 10 mg were 33.3%, 31.4%, 28.2%, and 26.8%, respectively, versus 20.7% for placebo ( p  = 0.033, 0.072, 0.201, 0.294 vs. placebo). Secondary efficacy endpoints (e.g. ≥50% responder rate, change from baseline in frequency of migraine/headache days, and percentage of severe migraines) had results favoring the three higher eptinezumab doses versus placebo. Eptinezumab was well tolerated and adverse event rates were similar to placebo.
CONCLUSIONS


The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02275117.",2019,"The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
","['chronic migraine', 'Men and women (N\u2009=\u2009616) aged 18-55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year']","['Eptinezumab', 'eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody', 'eptinezumab', 'placebo']","['migraine responder rates', 'tolerated and adverse event rates', 'safety, tolerability, and effectiveness', 'frequency of migraine/headache days, and percentage of severe migraines', 'percentage of patients with a ≥75% decrease in monthly migraine days']","[{'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]",616.0,0.663503,"The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': '1 Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': '2 Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': '3 Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""4 NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Biondi', 'Affiliation': '6 Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': '7 Pacific Northwest Statistical Consulting, Woodinville, WA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': '6 Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': '8 Alder BioPharmaceuticals Ltd, Dublin, Ireland.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419858355']
558,31310160,Increased Remission Rates After Long-Term Methimazole Therapy in Patients with Graves' Disease: Results of a Randomized Clinical Trial.,"Background:  Studies differ regarding whether, compared with courses of conventional duration, longer-term antithyroid drug treatment increases frequency of remission in patients with Graves' hyperthyroidism. We prospectively conducted a randomized, parallel-group study comparing relapse rates in patients receiving longer-term versus conventional-length methimazole therapy. We also sought variables associated with relapse following the latter.  Methods:  We enrolled 302 consecutive patients with untreated first episodes of Graves' hyperthyroidism. After 18-24 months of methimazole, 258 patients (85.4%) were randomized to an additional 36-102-month courses (""long-term group"":  n  = 130; scheduled total time on methimazole: 60-120 months) or discontinuation of methimazole (""conventional group"":  n  = 128). Patients were followed 48 months postmethimazole cessation. We performed Cox proportional hazards modeling to identify factors associated with relapse after conventional courses.  Results:  Methimazole was given for 95 ± 22 months in long-term patients and 19 ± 3 months in the conventional group. Fourteen patients experienced cutaneous reactions and 2 liver enzyme elevations during the first 18 months of treatment; no further methimazole-related reactions were observed despite therapy for up to another 118 months. Hyperthyroidism recurred within 48 months postmethimazole withdrawal in 15% (18/119) of long-term patients versus 53% (65/123) of conventional group patients. In the conventional group, older age, higher triiodothyronine or thyrotropin receptor antibody concentrations, lower thyrotropin concentration, or possession of the rs1879877  CD28  polymorphism or the  DQB1-05 HLA  polymorphism were independently associated with relapse.  C onclusion:  Administration of low-dose methimazole for a total of 60-120 months safely and effectively treats Graves' hyperthyroidism, with much higher remission rates than those attained by using conventional 18-24-month courses.",2019,Hyperthyroidism recurred within 48 months postmethimazole withdrawal in 15% (18/119) of long-term patients versus 53% (65/123) of conventional group patients.,"[""302 consecutive patients with untreated first episodes of Graves' hyperthyroidism"", 'patients receiving longer-term versus', ""Patients with Graves' Disease"", ""patients with Graves' hyperthyroidism""]","['additional 36-102-month courses (""long-term group"":  n \u2009=\u2009130; scheduled total time on methimazole: 60-120 months) or discontinuation of methimazole (""conventional group"":  n \u2009=\u2009128', 'conventional-length methimazole therapy', 'Methimazole', 'Methimazole Therapy', 'low-dose methimazole']","['relapse rates', 'triiodothyronine or thyrotropin receptor antibody concentrations, lower thyrotropin concentration, or possession of the rs1879877  CD28  polymorphism', 'cutaneous reactions and 2 liver enzyme elevations', 'Increased Remission Rates', 'Hyperthyroidism', 'remission rates', 'frequency of remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018213', 'cui_str': 'Graves Disease'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025644', 'cui_str': 'thiamazole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040139', 'cui_str': 'Thyroid-Stimulating Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",302.0,0.0574116,Hyperthyroidism recurred within 48 months postmethimazole withdrawal in 15% (18/119) of long-term patients versus 53% (65/123) of conventional group patients.,"[{'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Amouzegar', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tohidi', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Miralireza', 'Initials': 'M', 'LastName': 'Takyar', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0180']
559,32492080,Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial.,"Importance


Depression is associated with increased inflammation, which may precede its onset, especially in older people. Some preclinical data suggest potential antidepressant effects of aspirin, supported by limited observational data suggesting lower rates of depression in individuals treated with aspirin. There currently appears to be no evidence-based pharmacotherapies for the primary prevention of depression.
Objective


To determine whether low-dose aspirin (100 mg) reduces the risk of depression in healthy older adults.
Design, Setting, and Participants


This double-blinded, placebo-controlled randomized clinical trial was a substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which examined if aspirin increased healthy life span, defined as survival free of dementia and disability. The prespecified secondary outcome was depression. Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included.
Interventions


Participants were randomized to aspirin (100 mg daily) or placebo, with a median (interquartile range) follow-up of 4.7 (3.5-5.6) years.
Main Outcomes and Measures


The primary outcome was a proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item (CES-D-10) scale.
Results


Of the 19 114 participants enrolled in the trial, 9525 received aspirin and 9589 received a placebo. The mean (SD) age was 75.2 (4.0) years in the aspirin group and 75.1 (4.5) years in the placebo group; 9531 (56.4%) were women. Participants' demographics and clinical characteristics at baseline were similar between groups. A total of 79 886 annual CES-D-10 measurements were taken, with a mean of 4.2 measurements per participant. There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups. The incidence rate of new CES-D-10 scores of 8 or more was 70.4 events per 1000 person-years in the aspirin group and 69.1 in the placebo group (hazard ratio, 1.02 [95% CI, 0.96-1.08]; P = .54).
Conclusions and Relevance


Low-dose aspirin did not prevent depression in this large-scale study of otherwise healthy older adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01038583.",2020,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"['The mean (SD) age was 75.2\u2009(4.0) years in the aspirin group and 75.1\u2009(4.5) years in the placebo group; 9531 (56.4%) were women', 'otherwise healthy older adults', 'Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included', '19\u202f114 participants enrolled in the trial, 9525 received', 'healthy older adults', 'Older People']","['Aspirin vs Placebo', 'Aspirin', 'aspirin', 'low-dose aspirin', 'placebo']","['risk of depression', 'healthy life span', 'survival free of dementia and disability', 'depression', 'proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item', 'incidence rate of new CES-D-10\u2009scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",19114.0,0.692445,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, the Epworth Clinic, Epworth Healthcare, Camberwell, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1214']
560,31327306,Heavy Drinking among Women Receiving Intensive Motivational Interviewing: 6-Month Outcomes.,"Compared to men, women with alcohol use disorders experience more severe consequences related to drinking. Intensive Motivational Interviewing (IMI) is a new 9-session version of Motivational Interviewing (MI) designed for women with alcohol use disorders. The current study reports outcomes from a randomized clinical trial of IMI compared to a single session of MI. Data were collected at baseline, 2-month, and 6-month follow-up. In addition to a standard ""intent-to-treat"" (ITT) analysis, we conducted disaggregated subgroup analyses of women who were heavy drinkers and a ""per protocol"" (PP) analysis of women in the IMI condition who attended 7-9 sessions (80% of the IMI sample). Women in both study conditions made large reductions in drinking between baseline and 2 months that were maintained at 6 months. Generalized estimating equation (GEE) models using the full sample (N = 215) did not show time by condition differences, but heavy drinkers(n = 153) receiving IMI showed significantly larger reductions in drinking at 2- and 6-month follow-up than the comparison condition. Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points. Results support the efficacy of IMI in terms of reducing drinking, particularly among women who are heavy drinkers.",2019,Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points.,"['women who are heavy drinkers', 'women with alcohol use disorders', 'heavy drinkers', 'Women Receiving Intensive Motivational Interviewing', 'women who were heavy drinkers and a ""per protocol"" (PP) analysis of women in the IMI condition who attended 7-9 sessions (80% of the IMI sample']","['Intensive Motivational Interviewing (IMI', 'Motivational Interviewing (MI', 'IMI', 'standard ""intent-to-treat"" (ITT']",['Heavy Drinking'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",,0.0245226,Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Polcin', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Madhabika B', 'Initials': 'MB', 'LastName': 'Nayak', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Korcha', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Witbrodt', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Salinardi', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Gantt', 'Initials': 'G', 'LastName': 'Galloway', 'Affiliation': 'Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2019.1634302']
561,31317828,A pilot study of the effects of running training on visuospatial memory in MS: A stronger functional embedding of the hippocampus in the default-mode network?,"BACKGROUND/OBJECTIVE


Endurance exercise can improve memory function in persons with multiple sclerosis (pwMS), but the effects on hippocampal functioning are currently unknown. We investigated the effects of a running intervention on memory and hippocampal functional connectivity in pwMS.
METHODS/RESULTS


Memory and resting-state functional magnetic resonance imaging (fMRI) data were collected in a running intervention ( n  = 15) and waitlist group ( n  = 14). Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
CONCLUSION


As a result of endurance exercise, improvements in visuospatial memory may be mediated by a stronger functional embedding of the hippocampus in the DMN.",2020,"Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
","['persons with multiple sclerosis (pwMS', 'MS']","['running training', 'running intervention', 'Endurance exercise']","['Visuospatial memory improvement', 'memory function', 'memory and hippocampal functional connectivity', 'visuospatial memory']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0389327,"Visuospatial memory improvement was correlated to increased connectivity between the hippocampus and the default-mode network (DMN) in the intervention group only.
","[{'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Huiskamp', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lousin', 'Initials': 'L', 'LastName': 'Moumdjian', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Institute of Psychoacoustics and Electronic Music (IPEM), Faculty of Arts and Philosophy, Gent University, Gent, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Asch', 'Affiliation': 'Fit up Physiotherapy Center, Kontich, Belgium.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Popescu', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Rehabilitation and MS Centre Overpelt, Overpelt, Belgium.'}, {'ForeName': 'Menno Michiel', 'Initials': 'MM', 'LastName': 'Schoonheim', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn D', 'Initials': 'MD', 'LastName': 'Steenwijk', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Vanzeir', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Wijmeersch', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium; Rehabilitation and MS Centre Overpelt, Overpelt, Belgium.'}, {'ForeName': 'Jeroen Jg', 'Initials': 'JJ', 'LastName': 'Geurts', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, BIOMED, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Hanneke E', 'Initials': 'HE', 'LastName': 'Hulst', 'Affiliation': 'Department of Anatomy & Neurosciences, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519863644']
562,31090673,Firefighting Induces Acute Inflammatory Responses that are not Relieved by Aspirin in Older Firefighters.,"OBJECTIVE


Sudden cardiac events account for 40% to 50% of firefighter line-of-duty deaths. Inflammatory proteins are strong biomarkers of cardiovascular inflammation. The present study investigated the effects of aspirin supplementation on inflammatory biomarkers following firefighting.
METHODS


Using a randomized, placebo-controlled, double-blind crossover design, 24 male firefighters (48.2 ± 5.9 years) were allocated into four conditions: acute (81 mg; single-dose) aspirin and placebo supplementation, and chronic (81 mg; 14 days) aspirin and placebo supplementation. Inflammatory proteins [interleukin (IL)-6, C-reactive protein (CRP), intracellular adhesion molecule (ICAM)-1, P-selectin, matrix metalloproteinase-9 (MMP-9)] and antioxidant potential [total antioxidant capacity (TAC)] were measured pre- and post-structural firefighting drills.
RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected. Neither acute nor chronic aspirin supplementation attenuated this inflammatory response.
CONCLUSION


Firefighting significantly increases inflammatory biomarkers and neither acute nor chronic low-dose aspirin mitigates this response.",2019,"RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected.","['24 male firefighters (48.2\u200a±\u200a5.9 years', 'Older Firefighters']","['aspirin and placebo supplementation, and chronic (81\u200amg; 14 days) aspirin and placebo supplementation', 'Aspirin', 'placebo', 'aspirin supplementation']","['inflammatory biomarkers', 'IL-6, MMP-9, and P-Selectin', 'TAC and ICAM-1', 'Inflammatory proteins [interleukin (IL)-6, C-reactive protein (CRP), intracellular adhesion molecule (ICAM)-1, P-selectin, matrix metalloproteinase-9 (MMP-9)] and antioxidant potential [total antioxidant capacity (TAC']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.279146,"RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected.","[{'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Smith', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, New York (Drs Smith, Friedman, Bloom, Armero), School of Health Studies, University of Memphis, Memphis, Tennessee (Dr Pence), Department of Human Performance & Leisure Studies, North Carolina A&T State University, Greensboro, North Carolina (Dr Cook), Department of Kinesiology & Nutrition, Integrative Physiology Laboratory, University of Illinois at Chicago, Chicago, Illinois (Dr Fernhall), Department of Mechanical Science and Engineering, University of Illinois, Urbana-Champaign, Illinois (Dr Horn), Illinois Fire Service Institute, Urbana-Champaign, Illinois (Drs Horn, Smith), and Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois (Drs Horn, Woods).'}, {'ForeName': 'Nicholas M G', 'Initials': 'NMG', 'LastName': 'Friedman', 'Affiliation': ''}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Bloom', 'Affiliation': ''}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Armero', 'Affiliation': ''}, {'ForeName': 'Brandt D', 'Initials': 'BD', 'LastName': 'Pence', 'Affiliation': ''}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': ''}, {'ForeName': 'Gavin P', 'Initials': 'GP', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Woods', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001626']
563,31302695,Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.,"OBJECTIVE


This extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with SLE to continue belimumab treatment, in order to evaluate its long-term safety and tolerability including organ damage accrual.
METHODS


In this multicentre, long-term extension study (GlaxoSmithKline Study BEL112234) patients received i.v. belimumab every 4 weeks plus standard therapy. Adverse events (AEs) were assessed monthly and safety-associated laboratory parameters were assessed at regular intervals. Organ damage (SLICC/ACR Damage Index) was assessed every 48 weeks. The study continued until belimumab was commercially available, with a subsequent 8-week follow-up period.
RESULTS


A total of 738 patients entered the extension study and 735/738 (99.6%) received one or more doses of belimumab. Annual incidence of AEs, including serious and severe AEs, remained stable or declined over time. Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study. Eleven deaths occurred (and two during post-treatment follow-up), including one (cardiogenic shock) considered possibly related to belimumab. Laboratory parameters generally remained stable. The mean (s.d.) SLICC/ACR Damage Index score was 0.6 (1.02) at baseline (prior to the first dose of belimumab) and remained stable. At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual.
CONCLUSION


Belimumab displayed a stable safety profile with no new safety signals. There was minimal organ damage progression over 8 years.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov, NCT00424476 (BLISS-52), NCT00410384 (BLISS-76), NCT00732940 (BEL112232), NCT00712933 (BEL112234).",2020,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual.
","['patients with systemic lupus erythematosus treated with', '738 patients entered the extension study and 735/738 (99.6%) received one or more doses of', 'Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study']","['placebo', 'belimumab']","['Eleven deaths', 'Annual incidence of AEs, including serious and severe AEs', 'SLICC/ACR Damage Index score', 'minimal organ damage progression', 'Organ damage (SLICC/ACR Damage Index', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",738.0,0.202432,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual.
","[{'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra V', 'Initials': 'SV', 'LastName': 'Navarra', 'Affiliation': 'University of Santo Tomas Hospital, Manila, Philippines.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Levy', 'Affiliation': 'Rio de Janeiro State University, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Kerala Institute of Medical Sciences (KIMS), Kerala, India.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lustine', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Adamkovic', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fettiplace', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Mei-Lun', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez279']
564,31272953,Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial.,"AIMS


To compare amblyopic-eye visual acuity (VA) and binocularity improvement of a binocular game with part-time patching in the treatment of Chinese children with anisometropic amblyopia.
METHODS


103 Chinese children aged 3-13 years with anisometropic amblyopia were recruited in a randomised clinical trial. Eligible participants were randomly assigned to the binocular, patching and combined groups. Primary outcome was amblyopic-eye VA improvement at 3 months. Secondary outcomes included reduction of suppression and change of stereoacuity.
RESULTS


Of 85 completed participants, 44 (52%) were women and mean (SD) age was 5.99 (2.33) years. At 3 months, mean (95% CI) amblyopic-eye VA improved 0.18 (0.10-0.26), 0.28 (0.19-0.36) and 0.30 (0.21-0.39) logarithm of the minimum angle of resolution in the binocular, patching and combined groups, respectively. After adjusting for baseline VA, the difference was statistically significant (F=6.29, p=0.003), favouring as follows: the combined group, the patching group and the binocular group. After treatment, Titmus (x 2   binocular =9.75, p=0.007; x 2   combined =9.35, p=0.009) and dynamic stereoacuity (x 2   binocular =12.56, p=0.01; x 2   combined =12.66, p=0.01) improved only in the binocular and combined groups. Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001). Changes of other types of stereoacuity and interocular suppression were similar.
CONCLUSIONS


The binocular game used in this study could improve amblyopic-eye VA and binocularity in Chinese children with anisometropic amblyopia, but it was less effective than patching in amblyopic-eye VA improvement and showed no superiority in binocularity over patching. It remains unclear whether the low treatment response of this binocular game was due to limitations of the study or its low treatment effect.",2020,"Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001).","['anisometropic amblyopia in Chinese children', 'Of 85 completed participants, 44 (52%) were women and mean', 'Chinese children with anisometropic amblyopia', '103 Chinese children aged 3-13 years with anisometropic amblyopia', 'Eligible participants']","['Binocular game versus part-time patching', 'binocular game with part-time patching']","['amblyopic-eye VA improvement', 'reduction of suppression and change of stereoacuity', 'dynamic stereoacuity']","[{'cui': 'C0339696', 'cui_str': 'Anisometropic Amblyopia'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",103.0,0.341821,"Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China.'}, {'ForeName': 'Hye-Won', 'Initials': 'HW', 'LastName': 'Moon', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China quxiaomei2002@126.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313815']
565,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
566,31802405,Effects of Nintendo Wii fit game training on balance among Lebanese older adults.,"BACKGROUND


Falls are the second leading cause of accidental death, with persons older than 65 years being the most affected. Moreover, gait- and balance-related problems represent the most consistent predictors of future falls.
AIMS


The aim was to determine the effects of Wii fit game training on dynamic and static balance among Lebanese older adults.
METHODS


A randomized-controlled trial was conducted over a period of 8 weeks, where institutionalized older adults with no history of falls were randomized into two groups. The participants of each group were carefully followed up during the intervention and data collection periods. The intervention group was trained for standing balance during a 40-min session, starting with the ""Soccer Heading"" game during the first 4 weeks, followed by the ""Table Tilt"" game for the remaining 4 weeks. Timed up-and-go (TUG) test and the Nintendo Wii Balance Board were used to measure the dynamic and static balance, respectively, both at baseline and post-intervention.
RESULTS


Sixty-four participants recruited from both, the Tyre and Saida districts were enrolled in the study. Within-group comparison of TUG test values between baseline and post-intervention; both groups showed an extremely significant difference (P = 0.000). Similarly, the between-group comparison showed a significant difference (P = 0.013). Concerning the center of pressure measures, only the intervention group showed a very significant improvement between baseline and post-intervention measures (P = 0.002).
CONCLUSION


Wii fit balance training is a valid method for improving both dynamic and static balance among Lebanese older adults.",2020,"Concerning the center of pressure measures, only the intervention group showed a very significant improvement between baseline and post-intervention measures (P = 0.002).
","['Sixty-four participants recruited from both, the Tyre and Saida districts were enrolled in the study', 'Lebanese older adults', 'institutionalized older adults with no history of falls']","['Wii fit game training', 'Nintendo Wii fit game training']",['dynamic and static balance'],"[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0475255', 'cui_str': 'Tire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",64.0,0.0453489,"Concerning the center of pressure measures, only the intervention group showed a very significant improvement between baseline and post-intervention measures (P = 0.002).
","[{'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Fakhro', 'Affiliation': 'Faculty of Public Health, Department of Physical Therapy, Lebanese German University, Sahel Alma, Keserwan, P.O. Box 206, Jounieh, Lebanon. m.fakhro@lgu.edul.lb.'}, {'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Hadchiti', 'Affiliation': 'Faculty of Public Health, Department of Physical Therapy, Lebanese German University, Sahel Alma, Keserwan, P.O. Box 206, Jounieh, Lebanon.'}, {'ForeName': 'Baraa', 'Initials': 'B', 'LastName': 'Awad', 'Affiliation': 'Faculty of Public Health, Department of Physical Therapy, Lebanese German University, Sahel Alma, Keserwan, P.O. Box 206, Jounieh, Lebanon.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01425-x']
567,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
568,31250134,Determinants of anti-fibrotic response to mineralocorticoid receptor antagonist therapy: insights from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) and Early Eplerenone Treatment in Patients with Acute ST-elevation Myocardial Infarction without Heart Failure (REMINDER) trials.,"INTRODUCTION


After myocardial infarction complicated by heart failure or diabetes, eplerenone (compared to placebo) significantly decreases amino-terminal propeptide of type III procollagen (PIIINP). Determining the subset of patients who are more prone to have a decrease in PIIINP and those who may respond better to the anti-fibrotic effects of mineralocorticoid receptor antagonists (MRA) therapy may be relevant for a personalized treatment approach. The aim of this study is to identify predictors of a PIIINP decrease and assess potential subgroups of ""responders"" to eplerenone.
METHODS


Clinical factors and biomarkers were evaluated as predictors of a PIIINP decrease from randomization to month 9 in 323 patients from the biomarker substudy of Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Additionally, the association between PIIINP decrease and the composite of cardiovascular (CV) death or CV hospitalization were also explored. External validation was performed in the REMINDER trial.
RESULTS


Female sex, eplerenone, reperfusion therapy, potassium < 4 mmol/L, circulating levels of PIIINP ≥ 3.6 ng/mL and PINP ≥ 27 ng/mL predicted a PIIINP decrease (AUC = 0.75). Randomization PIIINP showed a significant interaction with the treatment allocation: patients with PIIINP ≥ 3.6 ng/mL had a better response (decrease in PIIINP) to eplerenone (OR for PIIINP ≥ 3.6 = 2.9, 95% CI 1.46-5.89, p = 0.003) and OR for PIIINP < 3.6 = 1.09, 95% CI 0.55-2.2, p = 0.8; interaction p  = 0.026). These findings were internally robust using another statistical approach (LOESS). External validation showed good discrimination (AUC = 0.70). There was a tendency toward a lower rate of CV death/CV hospitalizations in patients with decreased PIIINP (adjusted HR = 0.52, 95% CI 0.26-1.02, p = 0.058).
CONCLUSION


In patients who had a myocardial infarction, clinical factors used in combination and treatment with eplerenone were associated with a PIIINP decrease. Interestingly, higher randomization PIIINP levels might help in identifying patients more prone to have an ""anti-fibrotic response"" when treated with MRAs. Predictors of an antifibrotic response after MI complicated by HF. Several clinical factors and biomarkers predicted a PIIINP decrease after an MI complicated by HF. There was a significant interaction between baseline PIIINP levels and eplerenone treatment: patients with baseline PIIINP ≥ 3.6 mmol/L treated with eplerenone had the best response (PIIINP decrease).",2020,"There was a tendency toward a lower rate of CV death/CV hospitalizations in patients with decreased PIIINP (adjusted HR = 0.52, 95% CI 0.26-1.02, p = 0.058).
","['323 patients from the biomarker substudy of Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS', 'Patients with Acute ST-elevation Myocardial Infarction without Heart Failure (REMINDER) trials']","['eplerenone', 'mineralocorticoid receptor antagonists (MRA) therapy', 'placebo', 'mineralocorticoid receptor antagonist therapy']","['antifibrotic response', 'amino-terminal propeptide of type III procollagen (PIIINP', 'rate of CV death/CV hospitalizations', 'composite of cardiovascular (CV) death or CV hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0072054', 'cui_str': 'PCP III'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",323.0,0.045232,"There was a tendency toward a lower rate of CV death/CV hospitalizations in patients with decreased PIIINP (adjusted HR = 0.52, 95% CI 0.26-1.02, p = 0.058).
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stienen', 'Affiliation': ""INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.""}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Barros', 'Affiliation': 'Cardiovascular Research and Development Unit, Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Porto, Portugal.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Vandoeuvre lès Nancy, France. j.ferreira@chru-nancy.fr.""}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-019-01500-3']
569,31282006,Longer-term liraglutide administration at the highest dose approved for obesity increases reward-related orbitofrontal cortex activation in response to food cues: Implications for plateauing weight loss in response to anti-obesity therapies.,"AIMS


GLP-1 analogs have recently risen to the forefront as effective medications for lowering weight through actions in the central nervous system (CNS). However, their actions in the CNS have not yet been studied in the human brain after longer-term administration at the highest dose approved for obesity (liraglutide 3.0 mg).
MATERIALS AND METHODS


A total of 20 participants with obesity were treated with placebo and liraglutide (3.0 mg) in the context of a randomized, placebo-controlled, double-blind, cross-over trial after 5 weeks of dose escalation. Neurocognitive and neuroimaging (fMRI) responses to food cues were examined at the clinical research center of Beth Israel Deaconess Medical Center.
RESULTS


While using liraglutide, patients lost more weight (placebo-subtracted -2.7%; P < .001), had decreased fasting glucose (P < .001) and showed improved cholesterol levels. In an uncontrolled analysis, brain activation in response to food images was not altered by liraglutide vs placebo. When controlled for BMI/weight, liraglutide increased activation of the right orbitofrontal cortex (OFC) in response to food cues (P < .016, corrected for multiple comparisons).
CONCLUSIONS


In contrast to prior studies, we demonstrate for the first time that liraglutide treatment, administered over a longer period at the highest doses approved for obesity, does not alter brain activation in response to food cues. A counter-regulatory increase in reward-related OFC activation in response to food cues can be observed when neuroimaging data are controlled for BMI changes, indicating changes in CNS that could lead to later plateaus of weight loss. These data point to a promising focus for additional interventions which, by contributing to the CNS reward system, could provide tangible benefits in reversing the plateauing phenomenon and promoting further weight loss.",2019,"In an uncontrolled analysis, brain activations to food images were not altered in response to liraglutide vs. placebo.",['20 subjects with obesity were treated with'],"['liraglutide vs. placebo', 'placebo and liraglutide', 'placebo', 'liraglutide']","['Neurocognitive and neuroimaging (fMRI) responses', 'cholesterol levels', 'fasting glucose']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",20.0,0.0497411,"In an uncontrolled analysis, brain activations to food images were not altered in response to liraglutide vs. placebo.","[{'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jagriti', 'Initials': 'J', 'LastName': 'Upadhyay', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Rutagengwa', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'DiPrisco', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Ranta', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Adra', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Bapatla', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vivian P', 'Initials': 'VP', 'LastName': 'Douglas', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Konstantinos A A', 'Initials': 'KAA', 'LastName': 'Douglas', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nolen-Doerr', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mathew', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13827']
570,31801787,Sex Difference in Effects of Low-Dose Aspirin on Prevention of Dementia in Patients With Type 2 Diabetes: A Long-term Follow-up Study of a Randomized Clinical Trial.,"OBJECTIVE


To evaluate and compare the efficacy of long-term use of low-dose aspirin for the prevention of dementia in men and women.
RESEARCH DESIGN AND METHODS


This study is a follow-up cohort study of the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) trial, which was a randomized, open-label, standard care-controlled trial examining the effects of low-dose aspirin on cardiovascular events. We followed up 2,536 Japanese patients with type 2 diabetes (T2D) enrolled in the JPAD trial from 2002 to 2017. The primary outcome of this post hoc analysis was the incidence of dementia, which was defined by the prescription of antidementia drugs or admission due to dementia.
RESULTS


Among the originally enrolled patients, 2,121 (84%) retained their original allocation. During a median follow-up of 11.4 years, 128 patients developed dementia. The overall effect of low-dose aspirin on the prevention of dementia adjusted for age, sex, and other established risk factors was not significant (hazard ratio [HR] 0.82, 95% CI 0.58-1.16). However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
CONCLUSIONS


Long-term use of low-dose aspirin may reduce the risk for dementia in women with T2D.",2020,"However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
","['128 patients developed dementia', '2,536 Japanese patients with type 2 diabetes (T2D) enrolled in the JPAD trial from 2002 to 2017', 'Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD', 'dementia in men and women', 'Patients With Type 2 Diabetes', 'women with T2D']","['Low-Dose Aspirin', 'aspirin', 'low-dose aspirin']","['incidence of dementia, which was defined by the prescription of antidementia drugs or admission due to dementia', 'risk of dementia', 'cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C1276997', 'cui_str': 'Antidementia drug'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",128.0,0.195719,"However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
","[{'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Kumamoto, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Diabetes Care Center, Jinnouchi Hospital, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Department of Internal Medicine, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan morimoto@kuhp.kyoto-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1188']
571,31288266,A Novel Skin Closure Device for Total Knee Arthroplasty: Randomized Controlled Trial versus Staples.,"Twenty-five patients undergoing simultaneous, bilateral total knee arthroplasty (TKA) were randomized to receive skin closure with Zip device on one knee and staples on the other. Patients' pain and scar appearance were rated from 0 (best) to 10 (worst). Knee arc of motion was measured by a physical therapist. At 2 weeks postoperatively, pain scores were significantly better with the Zip device during device wear ( p  = 0.03) and during device removal ( p  = 0.003); arc of motion was significantly better with the Zip device ( p  = 0.002). At 8 weeks of follow-up, scar appearance was significantly better in the Zip device knee as rated by the patients (1.3 vs. 2.6,  p  = 0.04), the surgeon (1.9 vs. 3.3,  p  = 0.0006), and three independent plastic surgeons (3.7 vs. 4.8,  p  < 0.001). Results of this randomized controlled trial show that skin closure with the Zip device resulted in less pain and better scar appearance and knee arc of motion than with staples.",2020,"At 2 weeks postoperatively, pain scores were significantly better with the Zip device during device wear ( p  = 0.03) and during device removal ( p  = 0.003); arc of motion was significantly better with the Zip device ( p  = 0.002).","['Twenty-five patients undergoing simultaneous, bilateral total knee arthroplasty (TKA', 'Total Knee Arthroplasty']","['skin closure with Zip device', 'Novel Skin Closure Device', 'Zip device']","['scar appearance', 'pain and better scar appearance and knee arc of motion', 'pain and scar appearance', 'pain scores']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",25.0,0.0639227,"At 2 weeks postoperatively, pain scores were significantly better with the Zip device during device wear ( p  = 0.03) and during device removal ( p  = 0.003); arc of motion was significantly better with the Zip device ( p  = 0.002).","[{'ForeName': 'Rodney W', 'Initials': 'RW', 'LastName': 'Benner', 'Affiliation': 'Shelbourne Knee Center, Shelbourne Knee Center at Community East Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Behrens', 'Affiliation': 'Department of Orthopaedics, St. Louis University Hospital, St. Louis, Missouri.'}]",The journal of knee surgery,['10.1055/s-0039-1692628']
572,31537701,The pharmacogenomics of inhaled corticosteroids and lung function decline in COPD.,"Inhaled corticosteroids (ICS) are widely prescribed for patients with chronic obstructive pulmonary disease (COPD), yet have variable outcomes and adverse reactions, which may be genetically determined. The primary aim of the study was to identify the genetic determinants for forced expiratory volume in 1 s (FEV 1 ) changes related to ICS therapy.In the Lung Health Study (LHS)-2, 1116 COPD patients were randomised to the ICS triamcinolone acetonide (n=559) or placebo (n=557) with spirometry performed every 6 months for 3 years. We performed a pharmacogenomic genome-wide association study for the genotype-by-ICS treatment effect on 3 years of FEV 1  changes (estimated as slope) in 802 genotyped LHS-2 participants. Replication was performed in 199 COPD patients randomised to the ICS, fluticasone or placebo.A total of five loci showed genotype-by-ICS interaction at p<5×10 -6 ; of these, single nucleotide polymorphism (SNP) rs111720447 on chromosome 7 was replicated (discovery p=4.8×10 -6 , replication p=5.9×10 -5 ) with the same direction of interaction effect. ENCODE (Encyclopedia of DNA Elements) data revealed that in glucocorticoid-treated (dexamethasone) A549 alveolar cell line, glucocorticoid receptor binding sites were located near SNP rs111720447. In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele β 56.36 mL·year -1 , 95% CI 29.96-82.76 mL·year -1 ) and in patients who were assigned to placebo, although the relationship was weaker and in the opposite direction to that in the ICS group (C allele β -27.57 mL·year -1 , 95% CI -53.27- -1.87 mL·year -1 ).The study uncovered genetic factors associated with FEV 1  changes related to ICS in COPD patients, which may provide new insight on the potential biology of steroid responsiveness in COPD.",2019,"In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele beta=56.35 mL·year -1 , 95% confidence interval (CI)=29.96, 82.76 mL·yr -1 ) and also in patients who were assigned to placebo, though the relationship was weaker and in the opposite direction than that in the ICS group (C allele beta=-27.57 mL·year","['199 COPD patients randomised to the', '802 genotyped LHS-2 participants', 'COPD', 'COPD patients', 'patients with chronic obstructive pulmonary disease (COPD', '1116 COPD patients']","['Inhaled corticosteroids (ICS', 'ICS, triamcinolone acetonide', 'glucocorticoid treated (dexamethasone', 'placebo', 'ICS, fluticasone or placebo']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]",[],1116.0,0.231731,"In stratified analyses of LHS-2, genotype at SNP rs111720447 was significantly associated with rate of FEV 1  decline in patients taking ICS (C allele beta=56.35 mL·year -1 , 95% confidence interval (CI)=29.96, 82.76 mL·yr -1 ) and also in patients who were assigned to placebo, though the relationship was weaker and in the opposite direction than that in the ICS group (C allele beta=-27.57 mL·year","[{'ForeName': ""Ma'en"", 'Initials': 'M', 'LastName': 'Obeidat', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': 'Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Joubert', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, QC, Canada.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hao', 'Affiliation': 'Dept of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Dept of Pulmonology, GRIAC research institute, Groningen, The Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Rafaels', 'Affiliation': 'Division of Biomedical Informatics and Personalized Medicine, Dept of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Rasika', 'Initials': 'R', 'LastName': 'Mathias', 'Affiliation': 'Division of Genetic Epidemiology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Ruczinski', 'Affiliation': 'Dept of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Terri H', 'Initials': 'TH', 'LastName': 'Beaty', 'Affiliation': 'Dept of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen C', 'Initials': 'KC', 'LastName': 'Barnes', 'Affiliation': 'Division of Biomedical Informatics and Personalized Medicine, Dept of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'S F Paul', 'Initials': 'SFP', 'LastName': 'Man', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Paré', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': ""The University of British Columbia Center for Heart Lung Innovation, St Paul's Hospital Vancouver, BC, Canada.""}]",The European respiratory journal,['10.1183/13993003.00521-2019']
573,31303367,The Comparison of Traditional Radial Access and Novel Distal Radial Access for Cardiac Catheterization.,"OBJECTIVES


The traditional radial access (TRA) has been used almost routinely in coronary interventions in our clinic. Recently, we have started to use distal radial artery point as distal radial access (DRA) more frequently. The aim of this study is to compare these techniques (DRA and TRA) in terms of their safety, feasibility, and effectiveness.
BACKGROUND


Recently, the distal transradial access novel techniques have started to be used in coronary interventions, such as the anatomical snuffbox (AS) and DRA.
METHODS


This prospective, randomized study was carried out in a single center. The patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018. Consecutive patients with TRA (103 patients) and DRA (102 patients) were randomized for coronary intervention.
RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group. The radial artery spasm was observed in 4 cases in TRA group, whereas no radial artery spasm was seen in DRA group (p < 0.0001). The transradial access time in the DRA group (46.85 ± 2.41 s) lasted longer than the TRA (36.66 ± 5.16 s, p = 0.008).In DRA, hemostasis seems quicker than TRA.
CONCLUSIONS


DRA is feasible and safe for coronary angiography and interventions like TRA. It can be used as an alternative technique.",2020,"RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","['patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018', 'Consecutive patients with TRA (103 patients) and DRA (102 patients', 'cardiac catheterization']","['traditional radial access (TRA', 'TRA', 'DRA', 'traditional radial access and novel distal radial access', 'techniques (DRA and TRA']","['transradial access time', 'radial artery spasm', 'safety, feasibility, and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",103.0,0.0243291,"RESULTS


Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","[{'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Vefalı', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Sarıçam', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey. Electronic address: saricamersin@yahoo.com.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.07.001']
574,30797692,Effects of Acupressure on Sleep Quality and Psychological Distress in Nursing Home Residents: A Randomized Controlled Trial.,"OBJECTIVE


To compare the efficacy of acupressure with sham acupressure in older-adult nursing home residents presenting with poor sleep quality and psychological distress.
DESIGN


Prospective, randomized, double-blind, sham-controlled trial.
SETTING AND PARTICIPANTS


Sixty-two nursing home residents with poor sleep quality and psychological distress participated in this study. Participants were randomly assigned to an experimental group (n = 31) receiving acupressure at true acupoints (Baihui, Juque, Neiguan, Tianzhu, and Yongchung) or control group (n = 31) receiving acupressure at sham points. All participants received 20 minutes of acupressure before sleeping 3 times a week for 8 weeks. All participants were blinded to group allocation.
MEASURES


Sleep quality and psychological distress were measured using the Pittsburgh Sleep Quality Index and the Kessler Psychological Distress scale, respectively. Both groups' outcomes were assessed by assessors blinded to group allocation at the baseline, the end of the intervention, and 1 month after the intervention.
RESULTS


The experimental group demonstrated significantly more improvement in sleep quality than did the control group at the end of the intervention (10.5 vs 13.3) and 1 month after the intervention (8.3 vs 14.2; both P ≤ .001). Moreover, the experimental group had lower psychological distress levels than did the control group at 1 month after the intervention (14.6 vs 17.9, P = .05). Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P < .001) were observed in the experimental group between the measurements at baseline and after the intervention.
CONCLUSIONS


Acupressure at true acupoints improves sleep quality, reduces psychological distress, and provides more clinically beneficial effects compared with that at sham points. Future studies should examine whether these effects are maintained in the long term.",2019,"Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P ","['Nursing Home Residents', 'older-adult nursing home residents presenting with poor sleep quality and psychological distress', 'Sixty-two nursing home residents with poor sleep quality and psychological distress participated in this study']","['acupressure', 'acupressure with sham acupressure', 'Acupressure', 'acupressure at true acupoints (Baihui, Juque, Neiguan, Tianzhu, and Yongchung) or control group (n\xa0=\xa031) receiving acupressure']","['psychological distress', 'Sleep Quality and Psychological Distress', 'sleep quality, reduces psychological distress', 'Pittsburgh Sleep Quality Index and the Kessler Psychological Distress scale', 'lower psychological distress levels', 'sleep quality', 'Sleep quality and psychological distress', 'mean sleep quality']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.145583,"Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P ","[{'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Chen', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Pei', 'Initials': 'TP', 'LastName': 'Yeh', 'Affiliation': 'School of Nursing, China Medical University, Taichung, Taiwan; Department of Nursing, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Yueh-Chen', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taichung University of Science and Technology, Taichung, Taiwan.'}, {'ForeName': 'Mei-Ju', 'Initials': 'MJ', 'LastName': 'Chi', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan; School of Gerontology Health Management, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Mei-Wen', 'Initials': 'MW', 'LastName': 'Chen', 'Affiliation': 'Lee General Hospital affiliated Chunghwa Nursing Home, Taiwan.'}, {'ForeName': 'Kuei-Ru', 'Initials': 'KR', 'LastName': 'Chou', 'Affiliation': 'School of Nursing, Taipei Medical University, Taipei, Taiwan; Psychiatric Research Center, Taipei Medical University Hospital, Taipei, Taiwan; Department of Nursing, Taipei Medical University- Shuang Ho Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yin-Yi', 'Initials': 'YY', 'LastName': 'Lien', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Fen', 'Initials': 'CF', 'LastName': 'Yuan', 'Affiliation': ""Yuanli Lee's General Hospital, Lee's Medical Corporation, Taiwan. Electronic address: yuanhsc@livemail.tw.""}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.003']
575,31396815,Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial.,"BACKGROUND


Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown.
OBJECTIVE


To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control.
DESIGN


Three-arm pragmatic randomized controlled trial.
PATIENTS


One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit.
INTERVENTIONS


Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text).
MAIN MEASURES


Change in systolic BP during the final 4-month visit compared with baseline.
KEY RESULTS


At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
CONCLUSIONS


Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control.
TRIAL REGISTRATION


clinicaltrials.gov (NCT02778542).",2019,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","['One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12\xa0months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit']","['Electronic Pill Bottles or Bidirectional Text Messaging', 'electronic pill bottles or bidirectional text messaging', 'usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text']","['systolic blood pressure', 'systolic BP', 'blood pressure control', 'Hypertension Medication Adherence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",149.0,0.151629,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. shivan.mehta@uphs.upenn.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05241-x']
576,31226322,Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.,"OBJECTIVE


To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days.
STUDY DESIGN


In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15-45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion. Participants tracked bleeding/spotting days via daily electronic diaries for 30 days after starting drug treatment. We assessed participant satisfaction with their bleeding pattern and the IUS using a visual analog scale (0-100 mm). A sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t test, accounting for an expected 20% dropout rate.
RESULTS


From September 2016 to January 2018, 42 women enrolled. A total of 34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data. Mean bleeding/spotting days over 30 days did not differ between tamoxifen (12.0±5.8 days) and placebo users (16.8±9.0 days), p=.08. We found no significant differences in mean satisfaction with bleeding profiles (51 mm tamoxifen vs. 59 mm placebo, p=.48) or with the IUS (83 mm vs. 75 mm, p=.36) between groups. Both groups reported similar rates of adverse events, with no serious adverse events reported.
CONCLUSION


A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52-mg IUS.
IMPLICATIONS


Although tamoxifen treatment caused a trend toward modest bleeding/spotting day reduction in new levonorgestrel 52-mg IUS users, bleeding satisfaction did not improve. Future studies of tamoxifen treatment for IUS-related bleeding issues may be best targeted toward users with ongoing bleeding irregularities or lower-dose IUS products which cause more bleeding irregularities.",2019,"A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52mg IUS.
","['new users of the Levonorgestrel 52mg intrauterine system', 'From September 2016 to January 2018, 42 women enrolled', '34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data', 'recruited women ages 15-45years initiating the']","['Tamoxifen', 'placebo', 'levonorgestrel 52mg intrauterine system (IUS', 'levonorgestrel 52mg IUS insertion', 'levonorgestrel 52mg IUS', 'tamoxifen', 'tamoxifen 10mg or placebo', 'oral tamoxifen']","['bleeding/spotting days via daily electronic diaries', 'rates of adverse events', 'modest bleeding/spotting day reduction', 'Mean bleeding/spotting days over 30days', 'mean satisfaction with bleeding profiles', 'early breakthrough bleeding or satisfaction', 'unscheduled bleeding', 'bleeding satisfaction', 'participant satisfaction with their bleeding pattern and the IUS using a visual analog scale']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1596572', 'cui_str': 'Tamoxifen 10 MG [Nolvadex]'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",42.0,0.675474,"A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52mg IUS.
","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239. Electronic address: mcohen82@jhu.edu.'}, {'ForeName': 'Katharine B', 'Initials': 'KB', 'LastName': 'Simmons', 'Affiliation': 'The Permanente Medical Group, Department of Obstetrics & Gynecology, 2500 Merced Street, San Leandro, CA 94577.'}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239.'}]",Contraception,['10.1016/j.contraception.2019.06.009']
577,31038755,"Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial.","Hepatic encephalopathy (HE) can cause major morbidity despite standard of care (SOC; rifaximin/lactulose). Fecal microbial transplant (FMT) enemas postantibiotics are safe, but the effect of FMT without antibiotics using the capsular route requires investigation. The aim of this work was to determine the safety, tolerability, and impact on mucosal/stool microbiota and brain function in HE after capsular FMT in a randomized, single-blind, placebo-controlled clinical trial in Virginia. Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease) <17 on SOC were randomized 1:1 into receiving 15 FMT capsules versus placebo from a single donor enriched in Lachnospiraceae and Ruminococcaceae. Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression at baseline were used. Clinical follow-up with SOC maintenance was performed until 5 months. FMT-assigned patients underwent repeat endoscopies 4 weeks postenrollment. Twenty subjects on lactulose/rifaximin were randomized 1:1. MELD score was similar at baseline (9.6 vs. 10.2) and study end (10.2 vs. 10.5). Six patients in the placebo group required hospitalizations compared to 1 in FMT, which was deemed unrelated to FMT. Infection/HE episodes were similar between groups. Baseline microbial diversity was similar in all tissues between groups. Post-FMT, duodenal mucosal diversity (P = 0.01) increased with higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae. Reduction in Veillonellaceae were noted post-FMT in sigmoid (P = 0.04) and stool (P = 0.05). Duodenal E-cadherin (P = 0.03) and defensin alpha 5 (P = 0.03) increased whereas interleukin-6 (P = 0.02) and serum LBP (P = 0.009) reduced post-FMT. EncephalApp performance improved post-FMT only (P = 0.02). Conclusion: In this phase 1 study, oral FMT capsules are safe and well tolerated in patients with cirrhosis and recurrent HE. FMT was associated with improved duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance. Further studies are needed to prove efficacy.",2019,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"['17 on SOC', 'Twenty subjects on', 'Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease', 'patients with cirrhosis and recurrent HE', 'Hepatic Encephalopathy', 'Virginia']","['lactulose/rifaximin', 'placebo', 'Placebo', 'FMT capsules versus placebo', 'FMT']","['EncephalApp performance improved post-FMT', 'safe and well tolerated', 'Post-FMT, duodenal mucosal diversity', 'hospitalizations', 'Reduction in Veillonellaceae', 'serum LBP', 'higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae', 'HE episodes', 'Duodenal E-cadherin', 'Baseline microbial diversity', 'safety, tolerability, and impact on mucosal/stool microbiota and brain function', 'interleukin-6', 'MELD score', 'duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance', 'Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3826979', 'cui_str': 'MELD-Model for end-stage liver disease'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}]","[{'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042447', 'cui_str': 'Acidaminococcaceae'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C1003847', 'cui_str': 'Family Bifidobacteriaceae'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038394', 'cui_str': 'Streptococcaceae'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042172', 'cui_str': 'Cadherin-1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0202010', 'cui_str': 'Feces examination - general (procedure)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]",20.0,0.423193,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Nita H', 'Initials': 'NH', 'LastName': 'Salzman', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Gavis', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Holtz', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Matherly', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Majdi', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Puri', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30690']
578,31153114,The effect of NaOCl and heat treatment on static and dynamic mechanical properties and chemical changes of dentine.,"OBJECTIVES


To determine the effect of heat on flexural strength (FS), maximum strain (MS), storage modulus (SM), tan delta (TD) and chemical changes through micro-Raman spectroscopy of dentine exposed to 2.5% NaOCl or saline.
METHOD


ology: Dentine bars were randomly allocated to 8 test groups. Half (groups 2,4,6,8) were treated with NaOCl for 20 min; the rest (groups 1,3,5,7) remained in saline. FS/MS were measured in groups 1-4 (n = 15) (3/4 were also heated to 200 °C & re-hydrated in saline). Micro-Raman spectroscopy was performed on bars from groups 1-4. SM/TD were measured in 5-8: in 5/6 (n = 10), repeated after heating (200 °C), then following re-hydration; in 7/8 (n = 3) after heating to 25-185 °C.
RESULTS


Increase in MS on heat and FS/MS on heat + NaOCl was not significant (P > 0.05). SM increased (P = 0.06) after heat treatment but reduced to initial state after rehydration (P = 0.03). TD did not change (P = 0.4) after heat (200 °C) treatment but rehydration increased it compared with pre-treatment state (P = 0.001). For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post- (P = 0.03) heat-treatment states. SM and TD varied between 25-185 °C with no consistent trend amongst the NaOCl pre-treated bars. Micro-Raman only detected chemical changes following NaOCl treatment in the mineral phase.
CONCLUSIONS


Exposure of dentine bars to heat and NaOCl produced only moderate changes to quasi-static but marked changes to viscoelastic properties, which may be explained by chemical alterations.",2019,"For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post-",['ology'],"['saline', 'NaOCl', 'NaOCl and heat treatment']","['SM and TD', 'static and dynamic mechanical properties and chemical changes of dentine', 'MS on heat and FS/MS on heat\xa0+\xa0NaOCl', 'SM', 'SM/TD', 'flexural strength (FS), maximum strain (MS), storage modulus (SM), tan delta (TD) and chemical changes through micro-Raman spectroscopy of dentine', 'FS/MS']",[],"[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C1537110', 'cui_str': 'Skin tanning, function (observable entity)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037815', 'cui_str': 'Raman Spectroscopy'}]",,0.027041,"For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post-","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Karunanayake', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Ng', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK. Electronic address: y.ng@ucl.ac.uk.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Knowles', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK; Institute of Tissue Regeneration Engineering (ITREN) and Department of NanobiomedicalScience and BK21 Plus NBM, Global Research Center for Regenerative Medicine, DankookUniversity, 518-10, Anseo-dong, Dongnam-gu, Cheonan, Chungcheongnam-do, South Korea; The Discoveries Centre for Regenerative and Precision Medicine, UCL Campus, GowerStreet, London, WC1E 6BT, UK.'}, {'ForeName': 'A H S', 'Initials': 'AHS', 'LastName': 'Delgado', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gulabivala', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Nazhat', 'Affiliation': 'Department of Mining and Materials Engineering, McGill University, Montreal, Qc, H3A 0C5, Canada.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.05.042']
579,31201479,Cannabinoid modulation of opioid analgesia and subjective drug effects in healthy humans.,"RATIONALE


Dozens of preclinical studies have reported cannabinoid agonist potentiation of the analgesic effects of μ-opioid agonists.
OBJECTIVES


The aim of this study was to determine if a cannabinoid agonist could potentiate opioid analgesia in humans using several laboratory pain models.
METHODS


Healthy participants (n = 10) with/out current drug use/pain conditions completed this within-subject, double-blind, placebo-controlled, randomized outpatient study. Nine 8-h sessions were completed during which dronabinol (0, 2.5, 5 mg, p.o.) was administered 1 h before oxycodone (0, 5, 10 mg, p.o.) for a total of 9 test conditions. Outcomes included sensory threshold and tolerance from four experimental pain models (cold pressor, pressure algometer, hot thermode, cold hyperalgesia), along with participant- and observer-rated, performance and physiological effects.
RESULTS


Oxycodone produced miosis (p < 0.05) and analgesic responses (e.g., pressure algometer [p < 0.05]), while dronabinol did not (p > 0.05). Depending on the dose combination, dronabinol attenuated or did not alter oxycodone analgesia; for example, dronabinol (2.5 mg) decreased the analgesic effects of oxycodone (10 mg) on pressure tolerance. Conversely, dronabinol increased oxycodone subjective effects (e.g., drug liking) (p < 0.05); oxycodone (5 mg) ratings of ""high"" were potentiated by 5 mg dronabinol (p < 0.05; placebo = 1.1 [± 0.7]; 5 mg oxycodone = 4.7 [± 2.2]; 5 mg dronabinol = 9.9 [± 8.4]; 5 mg oxycodone + 5 mg dronabinol = 37.4 [± 11.3]).
CONCLUSIONS


This study indicates that dronabinol did not enhance the analgesic effects of oxycodone and increased abuse- and impairment-related subjective effects. These data suggest that dronabinol may not be an effective or appropriate opioid adjuvant; it could potentially increase opioid dose requirements, while increasing psychoactive opioid effects.",2019,"(p < 0.05); oxycodone (5 mg) ratings of ""high"" were potentiated by 5 mg dronabinol (p < 0.05; placebo = 1.1 [± 0.7]; 5 mg oxycodone = 4.7 [± 2.2]; 5 mg dronabinol = 9.9 [± 8.4]; 5 mg oxycodone + 5 mg dronabinol = 37.4 [± 11.3]).
","['healthy humans', 'Healthy participants (n\u2009=\u200910) with/out current drug use/pain conditions completed this within-subject, double-blind', 'humans using several laboratory pain models']","['cannabinoid agonist', 'oxycodone', 'placebo', 'dronabinol']","['sensory threshold and tolerance from four experimental pain models (cold pressor, pressure algometer, hot thermode, cold hyperalgesia), along with participant- and observer-rated, performance and physiological effects', 'miosis', 'analgesic responses', 'analgesic effects', 'oxycodone analgesia', 'pressure tolerance', 'oxycodone subjective effects (e.g., drug liking']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C2927148', 'cui_str': 'Cannabinoid Receptor Activators'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0036677', 'cui_str': 'Sensory Thresholds'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0728710', 'cui_str': 'Pupil constriction (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",10.0,0.28933,"(p < 0.05); oxycodone (5 mg) ratings of ""high"" were potentiated by 5 mg dronabinol (p < 0.05; placebo = 1.1 [± 0.7]; 5 mg oxycodone = 4.7 [± 2.2]; 5 mg dronabinol = 9.9 [± 8.4]; 5 mg oxycodone + 5 mg dronabinol = 37.4 [± 11.3]).
","[{'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Babalonis', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY, 40536, USA. babalonis@uky.edu.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lofwall', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY, 40536, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Sloan', 'Affiliation': 'Department of Anesthesiology, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nuzzo', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Fanucchi', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY, 40536, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05293-1']
580,31778249,Left bundle branch area pacing is superior to right ventricular septum pacing concerning depolarization-repolarization reserve.,"INTRODUCTION


Left bundle branch area pacing (LBBAP) has recently been reported to be a new physiological pacing strategy with clinical feasibility and safety. The present study aims to investigate depolarization-repolarization measures including QT interval, QT dispersion (QTD), and T peak-end  interval (T p  T e  ) in this novel LBBAP strategy.
METHODS AND RESULTS


A total of 131 pacing-indicated patients were prospectively enrolled and randomized to the LBBAP group (n = 66) and right ventricular septum pacing (RVSP) group (n = 65). LBBAP was successfully achieved in 61 subjects with stable lead performance and comparable complications (ie, pocket hematoma, lead perforation, and dislodgement) compared with RVSP. Of the 61 patients with successful LBBAP, the mean LV peak activation time was 67.89 ± 6.80 ms, with the LBB potential mapped in 46 cases (75.4%). Electrocardiogram (ECG) indices were compared between these two groups before and after implantation. As a result, LBBAP yielded a narrower paced QRS duration (121.49 ± 9.87 ms vs 145.62 ± 8.89 ms; P < .001), shorter QT interval (434.16 ± 32.70 ms vs 462.66 ± 32.04 ms; P < .001), and QT c  interval (472.44 ± 33.30 ms vs 499.65 ± 31.35 ms; P < .001), lower QTD (40.10 ± 8.68 ms vs 46.11 ± 10.85 ms; P = .001), and QT c  D (43.57 ± 8.78 ms vs 49.86 ± 11.98 ms; P = .001), and shorter T p  T e  (96.59 ± 10.76 ms vs 103.77 ± 10.16 ms; P < .001) than RVSP. However, T p  T e  /QT ratio did not differ between these two groups (0.223 ± 0.026 vs 0.225 ± 0.022; P = .733). Furthermore, LBBAP displayed less increased QRS duration, QT c  interval, QTD, QT c  D, and a more shortened QT interval compared with RVSP (all P < .05).
CONCLUSION


LBBAP proves to be a feasible and safe pacing procedure with better depolarization-repolarization reserve, which may predict lower risk of ventricular arrhythmia and sudden cardiac death.",2020,"T e  (96.59±10.76ms vs. 103.77±10.16ms, P<0.001) than RVSP.","['61 patients with successful LBBAP', 'group (n=65', '131 pacing-indicated patients']","['right ventricular septum pacing (RVSP', 'RVSP', 'Left bundle branch area pacing (LBBAP', 'LBBAP', 'Left bundle branch area pacing']","['Electrocardiogram (ECG) indices', 'pocket hematoma, lead perforation and dislodgement', 'QT interval, QT dispersion (QTD) and T peak-end  interval ', 'shorter QT interval', 'lower QTD', 'QRS duration, QT c  interval, QTD, QT c  D, and more shortened QT interval', 'T p  T e  /QT ratio', 'mean LV peak activation time', 'narrower paced QRS duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0225870', 'cui_str': 'Interventricular septum structure'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0225920', 'cui_str': 'Structure of bundle branches'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0151879', 'cui_str': 'Shortened QT interval (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",131.0,0.041933,"T e  (96.59±10.76ms vs. 103.77±10.16ms, P<0.001) than RVSP.","[{'ForeName': 'Jingfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Yixiu', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Echocardiography, Zhongshan Hospital, Shanghai Institute of Medical Imaging, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Yangang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Ruizhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14295']
581,31784442,Intradermal thumbtack needle buried Neiguan (P6) point for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative nausea and vomiting (PONV) is among the most common adverse reactions following anaesthesia and surgery. Recent clinical studies have reported that the average incidence is about 30%, while in patients specifically undergoing neurosurgery, the incidence can be as great as 73%. Studies also suggest that its occurrence increases the risk of intracranial haematoma and haemorrhage. The objective of this study is to evaluate the effectiveness of intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy in the prevention of PONV in patients undergoing craniotomy under general anaesthesia.
METHODS AND ANALYSIS


This is a single-centre, three-arm, randomised controlled trial. 180 participants are randomly assigned to either an acupuncture, intradermal thumbtack needle or control group in a 1:1:1 ratio. The P6 of the acupuncture group is punctured at both sides perpendicularly to a depth of 20 mm. Needles are retained for 30 min and stimulated every 10 min to maintain the de qi. The therapy includes two treatments; the acupuncture is administered immediately after and 24 hours after surgery. For the intradermal thumbtack needle group, the intradermal thumbtack needle is quickly inserted into the skin and embedded at P6 acupoints bilaterally. Patients and their families are asked to press the needlepoint with the onset of nausea, vomiting, bloating, pain and other reported discomforts. The needle is replaced after 24 hours. The therapy is administered immediately after and 24 hours after surgery. For the control group, no intervention is carried out. The incidence of PONV within 48 hours after craniotomy across the three groups is observed. Other observations include: (1) assessment of nausea score (severity of nausea) and pain score (visual analogue scale) 0-2, 2-6, 6-24 and 24-48 hours after craniotomy under general anaesthesia; (2) assessment of total rescue antiemetic dosage 0-48 hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management. We will perform all statistical analysis following the intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Bioethics Subcommittee of the West China Hospital, Sichuan University: the approval number is 2018 (number 231). Results will be expected to be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR1800017173.",2019,The incidence of PONV within 48 hours after craniotomy across the three groups is observed.,"['patients undergoing craniotomy under general anaesthesia', 'patients undergoing craniotomy', '180 participants']","['acupuncture', 'acupuncture, intradermal thumbtack needle or control', 'intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy', 'Intradermal thumbtack needle buried Neiguan (P6']","['risk of intracranial haematoma and haemorrhage', 'incidence of PONV', 'postoperative nausea and vomiting', 'total rescue antiemetic dosage 0-48\u2009hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management', 'nausea score (severity of nausea) and pain score (visual analogue scale', 'nausea, vomiting, bloating, pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031050', 'cui_str': 'Pericardium'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0596793', 'cui_str': 'Intracranial hematoma'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",180.0,0.107992,The incidence of PONV within 48 hours after craniotomy across the three groups is observed.,"[{'ForeName': 'Jian-Qin', 'Initials': 'JQ', 'LastName': 'Lv', 'Affiliation': 'Integrated Traditional and Western Medicine Department, Sichuan University West China Hospital, Chengdu, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Integrated Traditional and Western Medicine Department, Sichuan University West China Hospital, Chengdu, China wangchengwei@wchscu.cn.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tian-Hao', 'Initials': 'TH', 'LastName': 'Xu', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ling-Qi', 'Initials': 'LQ', 'LastName': 'Jian', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}]",BMJ open,['10.1136/bmjopen-2019-032417']
582,31772414,The Benefits of Combining Value for the Self and Others in Utility-Value Interventions.,"Utility-value interventions, in which students complete writing assignments about the personal usefulness of course material, show great promise for promoting interest and performance in introductory college science courses, as well as persistence in STEM fields. As researchers move toward scaling up this intervention, it's important to understand which features are key to its effectiveness. For example, prior studies have used different types of utility-value assignments (i.e., self-focused essays and other-focused letters) and different assignment structures (i.e., over time, researchers provided a variety of tasks or choices between tasks), without comparing them. It is not known whether these assignment features are incidental details or key aspects of the intervention that impact its effectiveness. In the current study, we systematically compared different utility-value assignments, as well as ways of combining them, in a randomized controlled trial in an introductory college biology course ( N  = 590). Specifically, we compared different versions of the intervention in terms of their relative effectiveness for promoting course performance and the motivational mechanisms through which they operated. The intervention was most effective when students had opportunities to write about utility for both the self and others. Grades were higher in conditions in which students were either assigned a variety of self-focused and other-focused assignments or given the choice between the two. Among students with low performance expectations, grades were higher when students were assigned a specific combination: a self-focused assignment followed by other-focused assignments. Results suggest that different versions of the intervention may work through different mechanisms.",2019,"Among students with low performance expectations, grades were higher when students were assigned a specific combination: a self-focused assignment followed by other-focused assignments.","['students with low performance expectations, grades were higher when students', 'introductory college biology course ( N  = 590']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],[],590.0,0.0723796,"Among students with low performance expectations, grades were higher when students were assigned a specific combination: a self-focused assignment followed by other-focused assignments.","[{'ForeName': 'Stacy J', 'Initials': 'SJ', 'LastName': 'Priniski', 'Affiliation': 'University of Wisconsin - Madison.'}, {'ForeName': 'Emily Q', 'Initials': 'EQ', 'LastName': 'Rosenzweig', 'Affiliation': 'University of Wisconsin - Madison.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Canning', 'Affiliation': 'Indiana University.'}, {'ForeName': 'Cameron A', 'Initials': 'CA', 'LastName': 'Hecht', 'Affiliation': 'University of Wisconsin - Madison.'}, {'ForeName': 'Yoi', 'Initials': 'Y', 'LastName': 'Tibbetts', 'Affiliation': 'University of Virginia.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Hyde', 'Affiliation': 'University of Wisconsin - Madison.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Harackiewicz', 'Affiliation': 'University of Wisconsin - Madison.'}]",Journal of educational psychology,['10.1037/edu0000343']
583,31750145,Comparative Study of Hearing Improvement of Type 1 Tympanoplasty Using Temporalis Fascia and Conchal Cartilage as Graft Material.,"Tympanic Membrane perforation is a common cause of hearing loss. Various surgical techniques with different types of graft materials have been described for the treatment of perforations. The conchal cartilage and temporalis fascia graft are most widely used. We conducted a prospective Randomized control trial at Sri Guru Ram Das Institute of Medical Sciences and Research to compare the post operative hearing outcomes between the patients of safe CSOM (n = 40) using temporalis fascia (n = 20) and conchal cartilage (n = 20). It was found that the AB gap closure at 2 months post-operatively was 11.55 ± 8.173 for conchal perichondrium group as compared to 10.49 ± 9.069 for temporalis fascia group. At 6 months the AB gap closure was 14.98 ± 9.915 for conchal cartilage group as compared 11.41 ± 8.288 db for temporalis fascia group. Thus hearing improvement was better for conchal cartilage group both at 2 and 6 months but the comparison of the AC gain at the end of 6 months and subjective improvement in hearing between the two techniques was not statistically significant owing to the small sample size of the study. Both Temporalis fascia and conchal cartilage with perichondrium were acceptable graft material for successful closure of tympanic membrane perforation, hearing improvement was better with conchal cartilage group.",2019,At 6 months the AB gap closure was 14.98 ± 9.915 for conchal cartilage group as compared 11.41 ± 8.288 db for temporalis fascia group.,['patients of safe CSOM (n\xa0=\xa040) using temporalis fascia (n\xa0=\xa020) and conchal cartilage (n\xa0=\xa020'],[],"['hearing improvement', 'AB gap closure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0225213', 'cui_str': 'Temporal fascia structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}]",[],"[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",,0.0175071,At 6 months the AB gap closure was 14.98 ± 9.915 for conchal cartilage group as compared 11.41 ± 8.288 db for temporalis fascia group.,"[{'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Bhardwaj', 'Affiliation': '1Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, 27-C, Sant Avenue, The Mall, Amritsar, 143001 India.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': '2Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, HIG 202, Sector-71, Mohali, 160071 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1248-0']
584,31750157,Comparative Analysis of Fascia Lata and Cartilage Graft in Revision Type 1 Tympanoplasty.,"To evaluate graft epithelialization and hearing outcome in type 1 revision tympanoplasty using fascia lata and cartilage as graft material. In this study 33 revision cases of dry central perforations were divided into two groups, group 1 (n = 21) in which cartilage was used as a graft and group 2 (n = 12) in which fascia lata was used. Group 1 patients were divided according to the technique used as group 1a (n = 16) cartilage perichondrium composite island graft and group 1b (n = 5) cartilage butterfly inlay graft. Patients were followed up for at least 12 months postoperatively, mean 15.63 (± 4.21) months. Outcome among the two groups were measured and compared in terms of graft epithelization and hearing improvement measured as the difference between pre and post operative mean air bone gap (ABG) at 1 year. The graft epithelialization of group 1 was 85.72% (87.5% group 1a/80% group 1b) and of group 2, 83.34%. Statistically no significant difference was found in the success rate between the two groups ( p  = 0.6). No significant difference was found in the hearing outcome as well ( p  = 0.44). The overall hearing improvement was significant in both groups ( p  = < 0.001) including the sub groups 1a and 1b separately. 21 out of 33 patients (63.63%) operated had a mean postoperative ABG of 20 db or less. The results of cartilage and fascia lata as graft are comparable in terms of graft epithelialization and hearing outcome in revision tympanoplasty.",2019,The overall hearing improvement was significant in both groups ( p  = < 0.001) including the sub groups 1a and 1b separately.,['33 revision cases of dry central perforations'],"['Fascia Lata and Cartilage Graft', 'cartilage perichondrium composite island graft and group 1b']","['graft epithelization and hearing improvement', 'success rate', 'graft epithelialization and hearing outcome', 'operative mean air bone gap (ABG', 'overall hearing improvement', 'mean postoperative ABG', 'hearing outcome', 'graft epithelialization']","[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]","[{'cui': 'C0015642', 'cui_str': 'Fascia Latas'}, {'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0225361', 'cui_str': 'Perichondrium (body structure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0022130', 'cui_str': 'Islands'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441863', 'cui_str': 'Group 1B (qualifier value)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]",,0.0226205,The overall hearing improvement was significant in both groups ( p  = < 0.001) including the sub groups 1a and 1b separately.,"[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Dave', 'Affiliation': 'Department of ENT, GCS Medical College, Ahmedabad, India.'}, {'ForeName': 'Suktara', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of ENT, GCS Medical College, Ahmedabad, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1286-7']
585,31750210,Randomised Controlled Clinical Study of Injection Caroverine and Ginkgo Biloba Extract in Cochlear Synaptic Tinnitus.,"Tinnitus, also known as phantom auditory perception, is an annoying symptom and 13-17% of population reports bothersome tinnitus. Cochlear synaptic tinnitus is the most common type. Many treatments have been tried but none is yet considered to be well established. To evaluate effect of Inj.Caroverine and Ginkgo Biloba extract in cochlear synaptic tinnitus in terms of improving tinnitus grading, tinnitus matching and quality of life of patient. It is Randomised controlled study, conducted in department of ENT, on 86 patients, who met inclusion criteria, divided into 4 groups. Gr1-Inj Caroverin, Gr2-Inj Placebo, Gr3-Ginkgo Biloba extract, Gr4-Placebo as extract. A single dose infusion of caroverine immediately improves tinnitus grading and matching and provides immediate relief in reducing severity of tinnitus in 54.54% cases but improvement was not sustained in caroverine group at 3 month and 6 month follow-up after infusion. Ginkgo biloba also is effective in improving tinnitus grading and matching in 31.8% cases and improvement was sustained in ginkgo biloba group even after 3 month of cessation of treatment i.e. at 6 month follow-up. It is suggested that Inj.Caroverine as intravenous infusion should be given in severe cases of tinnitus to reduce its severity immediately and then patient should be put on Tab.Ginkgo biloba for a period of 3 months to provide sustained and long lasting relief. Thus combination therapy of Inj.Caroverin and Tab.Ginkgo Biloba, appropriately tailored to the need of patient will provide better results in greater majority of patients.",2019,A single dose infusion of caroverine immediately improves tinnitus grading and matching and provides immediate relief in reducing severity of tinnitus in 54.54% cases but improvement was not sustained in caroverine group at 3 month and 6 month follow-up after infusion.,"['Cochlear Synaptic Tinnitus', '86 patients, who met inclusion criteria, divided into 4 groups']","['Caroverine and Ginkgo Biloba extract', 'caroverine', 'Gr1-Inj Caroverin, Gr2-Inj Placebo, Gr3-Ginkgo Biloba extract, Gr4-Placebo as extract', 'ginkgo biloba', 'Ginkgo Biloba', 'Caroverine', 'Injection Caroverine and Ginkgo Biloba Extract', 'Ginkgo biloba']","['severity of tinnitus', 'tinnitus grading, tinnitus matching and quality of life of patient']","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0108530', 'cui_str': 'caroverine'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0330206', 'cui_str': 'Maidenhair Tree'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",86.0,0.0603808,A single dose infusion of caroverine immediately improves tinnitus grading and matching and provides immediate relief in reducing severity of tinnitus in 54.54% cases but improvement was not sustained in caroverine group at 3 month and 6 month follow-up after infusion.,"[{'ForeName': 'Rajeev Kumar', 'Initials': 'RK', 'LastName': 'Nishad', 'Affiliation': '1Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal- Indore Highway, Bairagarh, Bhopal, MP 462030 India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': '1Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal- Indore Highway, Bairagarh, Bhopal, MP 462030 India.'}, {'ForeName': 'Mangal', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': '2MLN Medical College, Prayagraj, India.'}, {'ForeName': 'Reetu', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': '1Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal- Indore Highway, Bairagarh, Bhopal, MP 462030 India.'}, {'ForeName': 'Sanyogita', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': '1Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal- Indore Highway, Bairagarh, Bhopal, MP 462030 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01655-5']
586,31750211,Teaching Ear Examination Skill to Undergraduate Students Using Check List.,"For examination of ear, proper illumination is a pre requisite. Diseases related to ear may lead to altered sense of hearing and may affect normal balance system. If students are taught to examine ear using a check list, they may perform better. To teach ear examination to undergraduate students using a check list. Total 50 undergraduate students of M.B.B.S. attending E.N.T. clinic in Chirayu Medical College and Hospital were included in the study. They were given enrolment no. 1 to 50 and were divided into two groups. Group 1, enroll. no. 1 to 25 and group 2, enroll. no. 26 to 50. Group 1 was taught using check list and the Group 2 was taught without use of checklist. Both the groups were evaluated using check list. The group B students were again taught, using check list and were again evaluated using check list. Use of check list showed that there was statistically significant improvement in learning by students using check list in group 1 students compared to group 2 students who were taught without use of check list. The group 2 students also had improvement on evaluation, after they were taught using check list. Study suggests that use of check list for ear examination skill to undergraduate students has significant role and students learn better than when taught without use of checklist. Inclusion of checklist for teaching ear examination to undergraduate students may be considered.",2019,Use of check list showed that there was statistically significant improvement in learning by students using check list in group 1 students compared to group 2 students who were taught without use of check list.,"['Total 50 undergraduate students of M.B.B.S. attending E.N.T. clinic in Chirayu Medical College and Hospital were included in the study', 'undergraduate students']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],,0.0160774,Use of check list showed that there was statistically significant improvement in learning by students using check list in group 1 students compared to group 2 students who were taught without use of check list.,"[{'ForeName': 'Sanyogita', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal-Indore Highway, Bairagarh, Bhopal, M.P. 462030 India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Chirayu Medical College and Hospital Campus, Flat No. 203, A-Block, Bhopal-Indore Highway, Bairagarh, Bhopal, M.P. 462030 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01596-z']
587,31719080,Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.,"OBJECTIVE


To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet.
DESIGN


A multicentre, non-blinded randomised controlled trial.
SETTING


Five diabetes outpatient clinics in the Oslo region.
PARTICIPANTS


Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum.
INTERVENTION


The Pregnant+ app and usual care, the control group received usual care.
PRIMARY AND SECONDARY OUTCOMES


The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported.
RESULTS


No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered.
CONCLUSION


The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant.
TRIAL REGISTRATION NUMBER


NCT02588729.",2019,"The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity.","['Five diabetes outpatient clinics in the Oslo region', '238 women were randomised; 158 women completed the OGTT post partum', 'women with gestational diabetes mellitus (GDM', 'women with gestational diabetes mellitus', 'Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9\u2009mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant']","['Pregnant+ smartphone application', 'Pregnant', 'control group received usual care', 'routine postpartum oral glucose tolerance test (OGTT']","['proportion of emergency caesarean sections', 'adverse events', '2-hour glucose level', 'mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice', '2-hour blood glucose level', 'emergency caesarean section', 'Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity', '2-hour blood glucose level of the routine postpartum OGTT', 'birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit']","[{'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0564778', 'cui_str': 'Obstetric complication NOS'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]",238.0,0.0784032,"The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity.","[{'ForeName': 'Iren', 'Initials': 'I', 'LastName': 'Borgen', 'Affiliation': 'Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Anne Flem', 'Initials': 'AF', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Lisa Maria', 'Initials': 'LM', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Seraj', 'Initials': 'S', 'LastName': 'Fayyad', 'Affiliation': 'Department of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Noll', 'Affiliation': 'Department of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway milu@oslomet.no.'}]",BMJ open,['10.1136/bmjopen-2019-030884']
588,32068418,Mechanisms of change in female-specific and gender-neutral cognitive behavioral therapy for women with alcohol use disorder.,"OBJECTIVE


In a randomized trial for women with alcohol use disorders (AUD), the efficacy of Female-Specific Cognitive Behavioral Therapy (FS-CBT) was compared with Gender-Neutral CBT (GN-CBT; Epstein et al., 2018). The current study examined whether putative mechanisms of change differed between treatment conditions, using a novel statistical approach. Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
METHOD


Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment. Multilevel vector autoregression estimation was used to analyze associations between putative mechanisms of change, and network models of those associations were generated using network analysis.
RESULTS


Across conditions, higher confidence and coping were directly associated with less drinking; autonomy was directly and indirectly associated with drinking. Additionally, network analysis indicated that although variation in depression was associated with change in other variables specifically for GN-CBT, sociotropy was associated with change specifically in FS-CBT.
CONCLUSIONS


Women receiving CBT-AUD changed their drinking through increased confidence to abstain and greater use of coping skills. Autonomy played a central role in behavior change across treatment conditions. Participants receiving treatment tailored to women also changed through decreases in sociotropy and increases in social support for abstinence. For women who received standard CBT, changes in depression were important to clinical improvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","['women with alcohol use disorders (AUD', 'women with alcohol use disorder', 'Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment']",['Female-Specific Cognitive Behavioral Therapy (FS-CBT'],['social support for abstinence'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[{'cui': 'C0037438'}],99.0,0.0294468,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","[{'ForeName': 'Cathryn Glanton', 'Initials': 'CG', 'LastName': 'Holzhauer', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Epstein', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Center of Alcohol Studies, Rutgers University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000492']
589,31205205,Attending to Pesticide Exposure and Heat Illness Among Farmworkers: Results From an Attention Placebo-Controlled Evaluation Design.,"OBJECTIVE


The aim of this study was to determine the effectiveness of curricula for improving knowledge and attitudes pertaining to pesticide exposure and heat illness among immigrant Latino farmworkers.
METHODS


A pesticide safety curriculum informed by the revised Worker Protection Standard (WPS) was tested against an attention placebo-controlled curriculum (heat illness) in a sample of Latino farmworkers (N = 127).
RESULTS


Pesticide safety knowledge increased in the overall sample, but did not differ by curriculum assignment. Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (P < 0.05). Heat illness knowledge and behavioral intentions increased more for farmworkers assigned to the heat illness than the pesticide safety curriculum.
CONCLUSION


The developed curricula show good promise for meeting the spirit of the revised WPS and for reducing the burden of heat-related fatality and morbidity among Latino farmworkers.",2019,Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (p < .05).,"['Attending to Pesticide Exposure & Heat Illness among Farmworkers', 'immigrant Latino farmworkers', 'heat illness) in a sample of Latino farmworkers (N=127']",['placebo-controlled curriculum'],"['pesticide safety curriculum', 'Heat illness knowledge and behavioral intentions', 'Pesticide safety behavioral intentions']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1456556', 'cui_str': 'Heat illness'}, {'cui': 'C0221460', 'cui_str': 'Agricultural Workers'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C1456556', 'cui_str': 'Heat illness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0360092,Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (p < .05).,"[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Grzywacz', 'Affiliation': 'Florida State University, Department of Family & Child Sciences, Tallahassee, FL (Dr Grzywacz, Dr Gonzales-Backen, Marín, Trejo, Gudino), Migrant Clinicians Network, Division of Environmental and Occupational Health, Salisbury, MD (Liebman), Farmworker Association of Florida, Apopka, FL (Economos, Dr Tovar-Aguilar).'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gonzales-Backen', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liebman', 'Affiliation': ''}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Marín', 'Affiliation': ''}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Trejo', 'Affiliation': ''}, {'ForeName': 'Cecilia Ordaz', 'Initials': 'CO', 'LastName': 'Gudino', 'Affiliation': ''}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Economos', 'Affiliation': ''}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Tovar-Aguilar', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001650']
590,31763307,Comparative Study Between Endoscopic Sinus Surgery Using Microdebrider and Conventional Techniques with It's Impact on Pulmonary Function Tests: A Randomized Control Trial.,"The nasal airways and their close association to paranasal sinuses are an integral part of the respiratory tract. Mucociliary clearance is the predominant clearance mechanism for both upper and lower airways. The two components of mucociliary clearance are cilia and the secretions above them. It is known that CRS coexists in as many as 40-75% of patients with BA. CRS can present with polyposis or without polyposis. Treatment options for CRS include medical therapy, surgical intervention or both. According to recent guidelines, ESS is the most favourable surgical approach in patients who fail to respond adequately to medical therapy. To assess the extent of improvement in CRS following ESS (either microdebrider or conventional) and if it brings an improvement in the pulmonary function tests. This also assesses symptom scores, endoscopic appearances and CT findings pre-operatively and post-operatively. This study was carried out at the outpatient Department of Otorhinolaryngology and Head and Neck Surgery in Meenakshi Medical College, Hospital and Research Institute, Tamil Nadu. Patients were consented and started on medical treatment with systemic steroids for 2 weeks and topical nasal steroids for 1 month. If the disease persisted after medical therapy, patients were equally randomized into two groups of 30 each-microdebrider and conventional technique. Subjective symptoms of CRS were based on the CRS criteria. Symptoms score were given with Lund-Mckay symptoms scoring, pre-operatively 1 week before and post-operatively 2 months after surgery. Lund-Mckay CT scoring system separately assessed the extent of opacification of sinuses. PFT was assessed using Spirometer (KOKO Legend). There was a statistically considerable difference in the FEV1 values in microdebrider ESS than conventional ESS. Microdebrider ESS is considered superior when we have to address the coexistence of lower airway diseases along with CRS.",2019,There was a statistically considerable difference in the FEV1 values in microdebrider ESS than conventional ESS.,"['outpatient Department of Otorhinolaryngology and Head and Neck Surgery in Meenakshi Medical College, Hospital and Research Institute, Tamil Nadu', 'patients who fail to respond adequately to medical therapy']","['CRS', 'Endoscopic Sinus Surgery Using Microdebrider and Conventional Techniques', 'systemic steroids for 2\xa0weeks and topical nasal steroids']","['Pulmonary Function Tests', 'Mucociliary clearance', 'Subjective symptoms of CRS', 'FEV1 values', 'PFT']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary Transport'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0170955,There was a statistically considerable difference in the FEV1 values in microdebrider ESS than conventional ESS.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Muthubabu', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gayathri', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sravanthi', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'Saai Ram', 'Initials': 'SR', 'LastName': 'Thejas', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vinayak', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'Assadi', 'Initials': 'A', 'LastName': 'Rekha', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sindu', 'Affiliation': 'Department of Otorhinolaryngology and Neck and Neck Surgery, Meenakshi Medical College, Hospital and Research Institute, Karaipettai Post, Enathur, Kanchipuram, Tamil Nadu 631552 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1565-3']
591,31763315,"Randomised Comparison of Safety Profile and Short Term Response of Itraconazole, Voriconazole and Amphotericin B in the Management of Chronic Invasive Fungal Rhinosinusitis.","Chronic invasive fungal rhino sinusitis (CIFS) is a well described clinical entity characterized by mucosal and sub mucosal infiltration of mycotic organisms and angio-centric extension into orbital and intracranial structures. Itraconazole, Voriconazole and Amphotericin B are commonly used for CIFS. In the present study we have evaluated short term clinical response of these drugs. Thirty diagnosed patients of CIFS who presented to us from January 2011 to December 2015 were divided into three groups randomly. Group A, B and C received Itraconazole, Voriconazole and Amphotericin respectively. Visual Analogue scale (VAS), Lund Mackay (LM) radiological scores and Kupferberg's nasal endoscopic grades were seen and compared in all patients before treatment, after primary surgical debridement and biopsy and after post biopsy antifungal drug treatment. We assessed the serum drug levels using HPLC assay at 4 and 8 weeks of therapy and correlated them for efficacy and safety. All the groups had significant improvement after treatment compared to beginning of study. Inter group comparison showed that mean LM, NE and VAS scores were significantly better in Voriconazole group compared to Itraconazole and amphotericin B therapy. The reduction of these objective parameters with treatment was also significantly high in Voriconazole group compared to the other two groups. Voriconazole has shown to be the most effective treatment modality for chronic invasive fungal sinusitis compared to other commonly used drugs such as Itraconazole and Amphotericin B.",2019,"Inter group comparison showed that mean LM, NE and VAS scores were significantly better in Voriconazole group compared to Itraconazole and amphotericin B therapy.","['Chronic invasive fungal rhino sinusitis (CIFS', 'Chronic Invasive Fungal Rhinosinusitis', 'Thirty diagnosed patients of CIFS who presented to us from January 2011 to December 2015']","['Voriconazole', 'Itraconazole, Voriconazole and Amphotericin respectively', 'Itraconazole, Voriconazole and Amphotericin B', 'amphotericin B therapy', 'Itraconazole', 'Itraconazole and Amphotericin B']","['Visual Analogue scale (VAS), Lund Mackay (LM', 'efficacy and safety', ""radiological scores and Kupferberg's nasal endoscopic grades"", 'mean LM, NE and VAS scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0037199', 'cui_str': 'Sinus Infections'}, {'cui': 'C0948780', 'cui_str': 'Rhinosinusitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0085795', 'cui_str': 'Amphotericin'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0146649,"Inter group comparison showed that mean LM, NE and VAS scores were significantly better in Voriconazole group compared to Itraconazole and amphotericin B therapy.","[{'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Debbarma', 'Affiliation': '1Department of Otolaryngology, Head and Neck Surgery, Post Graduate Institute of Medical Education and Research, PGIMER, Sector-12, Chandigarh, India.'}, {'ForeName': 'Rijuneeta', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': '1Department of Otolaryngology, Head and Neck Surgery, Post Graduate Institute of Medical Education and Research, PGIMER, Sector-12, Chandigarh, India.'}, {'ForeName': 'Sourabha K', 'Initials': 'SK', 'LastName': 'Patro', 'Affiliation': '1Department of Otolaryngology, Head and Neck Surgery, Post Graduate Institute of Medical Education and Research, PGIMER, Sector-12, Chandigarh, India.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': '1Department of Otolaryngology, Head and Neck Surgery, Post Graduate Institute of Medical Education and Research, PGIMER, Sector-12, Chandigarh, India.'}, {'ForeName': 'Promila', 'Initials': 'P', 'LastName': 'Pandhi', 'Affiliation': '2Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Shafiq', 'Affiliation': '2Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01602-4']
592,31763316,Evaluation of Quality of Life and Pattern of Improvement of Bronchial Asthma in Chronic Rhinosinusitis Patients Treated by Functional Endoscopic Sinus Surgery.,"Chronic inflammatory disorders of the upper airways are extremely prevalent and have a major impact on public health. Sinusitis and bronchial asthma are closely interrelated diseases and sinusitis is known to influence bronchial asthma in its severity and chronicity. Causal relationships have been proposed but not yet proved. The relationship between sinusitis and asthma is academically interesting and has important diagnostic and therapeutic implications. The present study is designed to evaluate the efficacy of functional endoscopic sinus surgery done as treatment for chronic rhinosinusitis on bronchial asthma patients, in terms of quality of life and pattern of improvement. Objectives of the study were to determine whether bronchial asthma and quality of life improved after functional endoscopic sinus surgery. This was an open labelled randomised control trial, done at ENT Department of Medical College, Thiruvananthapuram. Those in Group A underwent functional endoscopic sinus surgery and group B patients were given only medicines as per standard protocol. All of them received asthma treatment depending on asthma attacks and severity and followed up at specific intervals. Quality of life status and pattern of improvement of bronchial asthma among these patients were evaluated. Patients of chronic rhinosinusitis treated by functional endoscopic sinus surgery showed significant improvement in the mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores. Functional endoscopic sinus surgery could be considered early in the natural course of chronic rhinosinusitis with concomitant bronchial asthma.",2019,"Patients of chronic rhinosinusitis treated by functional endoscopic sinus surgery showed significant improvement in the mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores.","['chronic rhinosinusitis with concomitant bronchial asthma', 'chronic rhinosinusitis on bronchial asthma patients', 'Chronic Rhinosinusitis Patients Treated by']","['Functional endoscopic sinus surgery', 'functional endoscopic sinus surgery', 'Functional Endoscopic Sinus Surgery']","['Quality of life status and pattern of improvement of bronchial asthma', 'bronchial asthma and quality of life', 'mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores', 'Quality of Life and Pattern of Improvement of Bronchial Asthma']","[{'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0156515,"Patients of chronic rhinosinusitis treated by functional endoscopic sinus surgery showed significant improvement in the mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sujatha', 'Affiliation': '1Department of otorhinolaryngology and head and neck surgery, Government Medical College, Trivandrum, Kerala India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Suja', 'Affiliation': '1Department of otorhinolaryngology and head and neck surgery, Government Medical College, Trivandrum, Kerala India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01586-1']
593,31784005,Objective evaluation of compliance after orthodontic treatment using Hawley or vacuum-formed retainers: A 2-center randomized controlled trial over a 3-month period.,"INTRODUCTION


The aim of this 2-arm parallel trial was to assess patient compliance objectively with Hawley or vacuum-formed retainers in the maxillary arch in a 3-month period after active orthodontic treatment through the use of the thermosensitive microsensor TheraMon.
METHODS


Patients who had just completed orthodontic treatment in the Postgraduate Orthodontic Clinic, School of Dentistry, National and Kapodistrian University of Athens and in a private orthodontic practice were randomly allocated to either the Hawley or vacuum-formed group for retention. Eligibility criteria included patients aged 12-18 years who had undergone orthodontic treatment in both arches for ≤ 5 years. The main outcome was the average objective daily difference in compliance measured with TheraMon between patients receiving either Hawley or vacuum-formed retainers in the maxillary arch for 3 months. Secondary outcomes pertained to the average objective difference in compliance between the 2 retainers for the first month in retention and the association between objective measurements of compliance and diary-reported duration of wear for both the first and 3- month periods. Randomization was implemented with a computer-generated randomization list; allocation was concealed in sequentially numbered, sealed, opaque envelopes. Blinding to the study protocol was not feasible either for the patient or orthodontist. Patients were instructed to wear the retainer full-time. Data were analyzed using nonparametric statistics and linear regression with standard errors based on the bootstrap method.
RESULTS


Seventy-seven patients (median age 14.8 years; interquartile range 1.5; range 12.1-17.6) were randomized in a 1:1 ratio to either a Hawley or vacuum-formed retainer. Baseline characteristics did not present significant differences between groups. One patient from the Hawley group was excluded from 3 months' follow-up owing to a microsensor fault. Objectively assessed median daily wear time for the Hawley group was 15.3 hours (interquartile range 6.8), whereas for the vacuum-formed group it was 18.3 hours (interquartile range 4.6) for the 3-month interval. Patients allocated to vacuum-formed retainers had higher wearing values of 2.10 h/d compared with the Hawley group, after adjusting for trial settings (mean difference 2.10; 95% confidence interval 0.32-3.89; P = 0.02). Patients from private orthodontic practice had an increased potential for compliance of 2.16 h/d compared with university settings after adjusting for type of appliance (mean difference 2.16; 95% confidence interval 0.34-3.97; P = 0.02). A significant correlation was detected between objective assessment and self-reported compliance for both retention protocols in the first and 3-month intervals. No harm was observed during follow-up.
CONCLUSIONS


This study found relatively high compliance in the short-term retention phase for both appliances. Vacuum-formed retainers were better accepted by adolescent patients, whereas those proceeding to private orthodontic practice were more compliant. There was a positive and statistically significant correlation between objective and subjective measures of compliance.
REGISTRATION


This trial was registered in ClinicalTrials.gov: NCT03683862.
FUNDING


No funding or conflict of interest to be declared.
PROTOCOL


The protocol was not published before trial commencement.",2019,"Patients allocated to vacuum-formed retainers had higher wearing values of 2.10 h/d compared with the Hawley group, after adjusting for trial settings (mean difference 2.10; 95% confidence interval 0.32-3.89; P = 0.02).","['Eligibility criteria included patients aged 12-18\xa0years who had undergone orthodontic treatment in both arches for', 'Seventy-seven patients (median age 14.8\xa0years; interquartile range 1.5; range 12.1-17.6', 'Patients who had just completed orthodontic treatment in the Postgraduate Orthodontic Clinic, School of Dentistry, National and Kapodistrian University of Athens and in a private orthodontic practice']","['Hawley or vacuum-formed group for retention', 'Vacuum-formed retainers', 'Hawley or vacuum-formed retainers']","['median daily wear time', 'objective and subjective measures of compliance', 'average objective difference in compliance between the 2 retainers for the first month in retention and the association between objective measurements of compliance and diary-reported duration of wear for both the first and 3- month periods', 'average objective daily difference in compliance measured with TheraMon', 'higher wearing values']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",77.0,0.240473,"Patients allocated to vacuum-formed retainers had higher wearing values of 2.10 h/d compared with the Hawley group, after adjusting for trial settings (mean difference 2.10; 95% confidence interval 0.32-3.89; P = 0.02).","[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Vagdouti', 'Affiliation': 'Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: georgiavagd13@hotmail.com.'}, {'ForeName': 'Effimia', 'Initials': 'E', 'LastName': 'Karvouni', 'Affiliation': 'Private practice, Volos, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Bitsanis', 'Affiliation': 'Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Koletsi', 'Affiliation': 'Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece; Clinic of Orthodontics and Pediatric Dentistry, School of Dental Medicine, University of Zurich, Zurich, Switzerland.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.008']
594,31081281,A multi-centre randomized controlled trial of open vs closed management of the rectal defect after transanal endoscopic microsurgery.,"AIM


Transanal endoscopic microsurgery (TEM) is a technically challenging strategy that allows expanded indications for local excision of rectal lesions. Transluminal suturing is difficult, so open management of the resultant defect is appealing. Expert opinion suggests there is more pain when the defect is left open. The aim of this study was to determine if closure of the defect created during full thickness excision of rectal lesions with TEM leads to less postoperative pain compared to leaving the defect open.
METHOD


At the time of surgery, patients undergoing a full thickness TEM were randomized to sutured (TEM-S) or open (TEM-O) management of the rectal defect. At five Canadian academic colorectal surgery centres, experienced TEM surgeons enrolled patients ≥ 18 years treated by full thickness TEM. The primary outcome was postoperative pain measured by the visual analogue scale. Secondary outcomes included postoperative pain medication use and 30-day postoperative complications, including bleeding, infection and hospital readmission.
RESULTS


Between March 2012 and October 2013, 50 patients were enrolled and randomized to sutured (TEM-S, n = 28) or open (TEM-O, n = 22) management of the rectal defect. There was no difference between the two study groups in postoperative pain on postoperative day 1 (2.8 vs 2.6, P = 0.76), day 3 (2.8 vs 2.1, P = 0.23) and day 7 (2.8 vs 1.7, P = 0.10).
CONCLUSION


In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.",2019,"In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.","['Between March 2012 and October 2013, 50 patients were enrolled and randomized to', 'patients undergoing a full thickness TEM', 'patients having a full thickness excision with TEM', 'At five Canadian academic colorectal surgery centres, experienced TEM surgeons enrolled patients ≥']","['sutured (TEM-S) or open (TEM-O) management of the rectal defect', 'TEM', 'Transluminal suturing', 'full thickness TEM', 'sutured (TEM-S, n\xa0=\xa028) or open (TEM-O, n\xa0=\xa022', 'transanal endoscopic microsurgery', 'Transanal endoscopic microsurgery (TEM']","['postoperative pain', 'postoperative pain measured by the visual analogue scale', 'postoperative pain medication use and 30-day postoperative complications, including bleeding, infection and hospital readmission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0522520', 'cui_str': 'Transluminal approach (qualifier value)'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C4042939', 'cui_str': 'Transanal Endoscopic Microsurgery'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",50.0,0.128426,"In this multicentre randomized controlled trial, there was no difference in postoperative pain between sutured or open defect management in patients having a full thickness excision with TEM.","[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Brown', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hochman', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Raval', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': 'Department of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Phang', 'Affiliation': ""Department of Surgery, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bouchard', 'Affiliation': 'Department of Surgery, CHU de Québec - Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Drolet', 'Affiliation': 'Department of Surgery, CHU de Québec - Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boushey', 'Affiliation': 'Department of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14689']
595,31763264,Endoscopic Submucosal Resection Versus Endoscopic Submucosal Diathermy for Inferior Turbinate Hypertrophy.,"Endoscopic submucous resection and endoscopic submucous diathermy of the inferior turbinate are two different surgical methods of reducing size in turbinate hypertrophy. We aimed to compare the efficacy of both methods in reducing the nasal symptoms and improving nasal airway. This is a prospective randomized controlled trial conducted in a tertiary hospital, involving fifty patients with inferior turbinate hypertrophy not relieved by medications. After preoperative airway grading using a subjective symptom score, objective airway score and endoscopic score, patients were randomized to undergo either endoscopic submucous diathermy or endoscopic submucous resection. The primary outcome was postoperative improvement of airway and reduction of nasal symptoms. Secondary outcomes were postoperative bleeding and pain. All 24 patients who underwent endoscopic submucous diathermy and 26 who underwent endoscopic submucous resection showed statistically significant reduction in nasal symptoms both in the immediate and late postoperative periods. Patients who underwent endoscopic submucous resection showed greater improvement of airway at 1 week than those who had endoscopic submucous diathermy ( p  = 0.001). This difference however equalized at the 3-6 months postoperative period. Postoperative bleeding ( p  = 0.02) and pain ( p  = 0.04) were significantly more in patients who underwent endoscopic submucous resection. Both endoscopic submucous diathermy and endoscopic submucous resection are equally effective in improving airway in inferior turbinate hypertrophy with a slight advantage of endoscopic submucous resection in the early postoperative period. Reduced postoperative bleeding and pain may make endoscopic submucous diathermy a more attractive option overall.",2019,Patients who underwent endoscopic submucous resection showed greater improvement of airway at 1 week than those who had endoscopic submucous diathermy ( p  = 0.001).,['fifty patients with inferior turbinate hypertrophy not relieved by medications'],"['Endoscopic Submucosal Resection Versus Endoscopic Submucosal Diathermy', 'endoscopic submucous diathermy', 'Endoscopic submucous resection and endoscopic submucous diathermy', 'endoscopic submucous resection', 'endoscopic submucous diathermy or endoscopic submucous resection', 'endoscopic submucous diathermy and endoscopic submucous resection']","['postoperative bleeding and pain', 'postoperative improvement of airway and reduction of nasal symptoms', 'Postoperative bleeding', 'nasal symptoms and improving nasal airway', 'pain', 'nasal symptoms', 'improvement of airway', 'subjective symptom score, objective airway score and endoscopic score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0225434', 'cui_str': 'Inferior turbinated bone'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0332303', 'cui_str': 'Relieved by (attribute)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0188993', 'cui_str': 'Submucous resection of nasal septum (procedure)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device (physical object)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",50.0,0.0279427,Patients who underwent endoscopic submucous resection showed greater improvement of airway at 1 week than those who had endoscopic submucous diathermy ( p  = 0.001).,"[{'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Lukka', 'Affiliation': 'Department of Otorhinolaryngology, Christian Medical College, Vellore, 632004 India.'}, {'ForeName': 'Regi', 'Initials': 'R', 'LastName': 'Kurien', 'Affiliation': 'Department of Otorhinolaryngology, Christian Medical College, Vellore, 632004 India.'}, {'ForeName': 'Lalee', 'Initials': 'L', 'LastName': 'Varghese', 'Affiliation': 'Department of Otorhinolaryngology, Christian Medical College, Vellore, 632004 India.'}, {'ForeName': 'Vedantam', 'Initials': 'V', 'LastName': 'Rupa', 'Affiliation': 'Department of Otorhinolaryngology, Christian Medical College, Vellore, 632004 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1280-0']
596,31763269,Effectiveness of Over-The-Counter Intranasal Preparations: A Randomized Trial.,"To compare the effectiveness of over-the-counter normal saline with nasal decongestant drops for the symptomatic relief of nasal congestion, and to determine if nasal drops used alone are effective in the treatment of patients suffering from nasal congestion. Prospective, randomized double blinded study. Otorhinolaryngology Outpatient Department. Patients suffering from nasal congestion and similar symptoms such as nasal discharge, dryness, crusting, sneezing, itching and loss of smell. Resolution of symptoms based on visual analog scale and objective findings on anterior rhinoscopy. Chi-square test was done for comparison between the saline and decongestant groups. Subgroup analysis was done for patients on additional medication such as antibiotics. The  p  value is 0.701671 for the effectiveness of saline against that of decongestant, thus no significant difference exists between them for the relief of nasal congestion. The  p  value is 0.007497 for those on antibiotics and those that were treated only with nasal drops, thus showing a significant difference (level of significance being  p  < 0.05). The effectiveness of both nasal saline and decongestant drops in bringing about relief of nasal congestion is similar, and both of them may also cause headache though the mechanism is not well understood from this study. Relief might be primarily obtained with the help of oral medication and not the use of nasal drops.  Level of evidence : Single-center randomized trial, level II b.",2019,"The  p  value is 0.701671 for the effectiveness of saline against that of decongestant, thus no significant difference exists between them for the relief of nasal congestion.","['patients suffering from nasal congestion', 'Patients suffering from nasal congestion and similar symptoms such as', 'Otorhinolaryngology Outpatient Department']",['nasal saline and decongestant drops'],"['nasal discharge, dryness, crusting, sneezing, itching and loss of smell']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0282374', 'cui_str': 'Decongestants'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0392749', 'cui_str': 'Crusted (qualifier value)'}, {'cui': 'C0037383', 'cui_str': 'Sneezings'}, {'cui': 'C0003126', 'cui_str': 'Anosmia'}]",,0.08719,"The  p  value is 0.701671 for the effectiveness of saline against that of decongestant, thus no significant difference exists between them for the relief of nasal congestion.","[{'ForeName': 'Lakshana', 'Initials': 'L', 'LastName': 'Deve', 'Affiliation': 'Department of ENT, Pondicherry Institute of Medical Sciences, Pondicherry, 605014 India.'}, {'ForeName': 'Jayita', 'Initials': 'J', 'LastName': 'Poduval', 'Affiliation': 'Department of ENT, Pondicherry Institute of Medical Sciences, Pondicherry, 605014 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1331-6']
597,31763287,Functional Endoscopic Sinus Surgery of Nasal Polyposis: The Vexing Question of Whether to Resect or Preserve Middle Turbinate.,"Functional endoscopic sinus surgery is the mainstay of surgical management of nasal polyposis since 1975. The decision between the partial resection and preservation of the middle turbinate (MT) has stirred up considerable debate. Partial MTR permits easy access to the affected paranasal sinuses intraoperatively and postoperatively. However, there may be alteration of nasal function, frontal sinusitis and anosmia. Preservation of middle turbinate is precludes these complications, and allows the MT to serve as a vital anatomical landmark for revision surgery. Therefore, our study compared the outcomes of the two approaches to aid surgeons in deciding the best possible approach. Randomized control trial. 31 patients (60 sides of nasal cavity) with nasal polyposis were divided into two groups. Group I consisted of 30 sides of nasal cavity with middle turbinate resection, while group II consisted of 30 sides of nasal cavity without middle turbinate resection. Both the groups were compared postoperatively for 6 months. In group I and group II, 5 sides (16.6%) and 11 sides (36.6%) showed polypoidal changes respectively. 3 sides (10%) in group I and 8 sides (26.6%) in group II showed blockage of maxillary sinus ostia. All the sides in group I had patency of frontal sinus. In group II, 5 sides (16.6%) showed blockage of frontal sinus ostia. The maxillary antrostomy patency in group I and group II were 90% (27) and 73.33% (22) respectively. Assessment of symptomatic improvements for nasal obstruction, hyposmia, headache and rhinorrhoea was done using questionnaires. Symptomatic improvement was higher in group I compared to group II with statistical significance ( p  = 0.001). Our study demonstrated that partial resection of middle turbinate decreased the chances of recurrence of disease and post-operative complications and resulted in significantly better symptomatic improvements.",2019,Symptomatic improvement was higher in group I compared to group II with statistical significance ( p  = 0.001).,"['31 patients (60 sides of nasal cavity) with nasal polyposis', 'Functional Endoscopic Sinus Surgery of Nasal Polyposis']","['Functional endoscopic sinus surgery', 'nasal cavity with middle turbinate resection, while group II consisted of 30 sides of nasal cavity without middle turbinate resection']","['patency of frontal sinus', 'blockage of maxillary sinus ostia', 'chances of recurrence of disease and post-operative complications', 'maxillary antrostomy patency', 'nasal obstruction, hyposmia, headache and rhinorrhoea', 'Symptomatic improvement', 'blockage of frontal sinus ostia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure (body structure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure (body structure)'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0016734', 'cui_str': 'Frontal Sinus'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",60.0,0.0208786,Symptomatic improvement was higher in group I compared to group II with statistical significance ( p  = 0.001).,"[{'ForeName': 'Manaswita', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Otorhinolaryngology, Vardhman Mahavir Medical College and Safdarjung Hospital, Arjun Nagar, Safdarjung Enclave, New Delhi, 110029 India.'}, {'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Lade', 'Affiliation': 'Department of Otorhinolaryngology, Vardhman Mahavir Medical College and Safdarjung Hospital, Arjun Nagar, Safdarjung Enclave, New Delhi, 110029 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1450-0']
598,31763300,Mitomycin-C in Post-endoscopic Septoplasty Synechiae: Does it Really Helps?,"Endoscopic septoplasty has advantage of magnified image and access to posterior part of the septum. Synechiae formation is a common complication of this procedure. The incidence of adhesions rises particularly in cases of submucosal flap tears which is sometimes unavoidable during spurectomy. Various procedures like septal splints, nasal packings have been tried to reduce the incidence of adhesions. Recently mitomycin-C is being tried to decrease post operative adhesions after Functional Endoscopic Sinus Surgery, endoscopic Dacrocystorhinostomy, with varying degree of success. Mitomycin-C has got anti fibroblastic activity, which inhibits the fibroblasts without hampering epithelization. Eighty (80) Patients undergoing septoplasty and spurectomy were observed for any submucosal flap tear, and those developing flap tear were included in the study. The patients were divided into 2 groups of 40 each. In group-1 topical mitomycin (0.4 mg/ml) was applied at the raw area for 5 min, similarly normal saline was applied in group-2 (control).The aim of study was to evaluate the role of mitomycin-C in preventing post operative adhesions in Endoscopic septoplasty. Adhesion rate was calculated at 1 month, and compared using Chi square test.  P  value < 0.05 was considered significant. The adhesion rate at 1 month was 17.5% in group-1 and 45% in group-2 ( P  = 0.008). Incidence of adhesion decreased significantly in mitomycin-C treated group. Mitomycin-C can routinely be used in septoplasty to prevent post op adhesions, particularly in cases of submucosal flap tears/concurrent turbinate reduction procedures.",2019,The adhesion rate at 1 month was 17.5% in group-1 and 45% in group-2 ( P  = 0.008).,"['Patients undergoing septoplasty and spurectomy were observed for any submucosal flap tear, and those developing flap tear were included in the study', 'Eighty (80', 'Post-endoscopic Septoplasty Synechiae']","['mitomycin-C', 'Endoscopic septoplasty', 'group-1 topical mitomycin', 'Mitomycin-C']","['Incidence of adhesion', 'adhesion rate', 'Adhesion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C3697690', 'cui_str': 'Flap Tears'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}]",,0.0266625,The adhesion rate at 1 month was 17.5% in group-1 and 45% in group-2 ( P  = 0.008).,"[{'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Sayeed', 'Affiliation': 'Department of Otorhinolaryngology, Jawahar Lal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'Mehtab', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Department of Otorhinolaryngology, Jawahar Lal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'Satish Chandra', 'Initials': 'SC', 'LastName': 'Sharma', 'Affiliation': 'Department of Otorhinolaryngology, Jawahar Lal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'Syed Abrar', 'Initials': 'SA', 'LastName': 'Hasan', 'Affiliation': 'Department of Otorhinolaryngology, Jawahar Lal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1496-z']
599,31471729,Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial.,"IMPORTANCE


Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.
OBJECTIVE


To test the effectiveness of a prediabetes SDM intervention.
DESIGN


Cluster randomized controlled trial.
SETTING


Twenty primary care clinics within a large regional health system.
PARTICIPANTS


Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.
INTERVENTION


Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.
MAIN OUTCOMES AND MEASURES


Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.
RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001).
LIMITATIONS


Absence of DPP supplier participation data for matched patients in usual care clinics.
CONCLUSIONS AND RELEVANCE


A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk.
TRIAL REGISTRATION


This study was registered at clinicaltrails.gov (NCT02384109)).",2019,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","['patients with prediabetes', 'SDM participants (n\xa0=\u2009351) than controls receiving usual care ', 'Overweight/obese adults with prediabetes (BMI\u2009≥\u200924\xa0kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics', 'matched patients in usual care clinics', 'Diabetes Prevention', 'Twenty primary care clinics within a large regional health system']","['Shared decision-making (SDM', 'metformin', 'Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care', 'prediabetes SDM intervention']","['uptake of DPP (≥\u20099 sessions), metformin, or both strategies at 4\xa0months', 'weight loss', 'weight change', 'Uptake of DPP and/or metformin', 'adjusted weight loss', 'uptake of DPP and/or metformin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",20.0,0.044247,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Moin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Turk', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Chon', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Dominick L', 'Initials': 'DL', 'LastName': 'Frosch', 'Affiliation': 'Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Kia Skrine', 'Initials': 'KS', 'LastName': 'Jeffers', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Yelba', 'Initials': 'Y', 'LastName': 'Castellon-Lopez', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Norris', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05238-6']
600,31712337,Study protocol for an investigation of the effectiveness of the pain toolkit for people with low back pain: double-blind randomised controlled trial.,"INTRODUCTION


The Pain Toolkit is a self-management tool for people with persistent pain. It is available for use worldwide in multiple formats. To date, no studies have investigated the effectiveness of this intervention. This study aims to investigate the effectiveness of the Pain Toolkit in comparison with a simple education control for people with low back pain.
METHODS AND ANALYSIS


Participants who have been discharged from the North of England Regional Back Pain Pathway will be randomised using sealed, consecutively numbered opaque envelopes to receive either the Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group). Both the therapist and the participant will be blind to group allocation. The primary outcome measure will be disability (Oswestry Disability Index (ODI)). Secondary outcome measures will be pain (0-10 numerical scale), healthcare use (number of healthcare professional visits) and quality of life (EuroQol-5D). Outcome measures will be completed at baseline and at 6 and 12 months. Data will be analysed using analysis of covariance, adjusting for baseline values. A change of 10 points in the ODI will be considered a clinically important change. Additionally, a subsample of participants from the intervention group will undergo semistructured interviews to explore individuals' experience of the Pain Toolkit. Participants will be asked questions about the ease of use and acceptability of the Pain Toolkit and also for how long they used the Toolkit. The qualitative data will be analysed using thematic analysis.
ETHICS AND DISSEMINATION


Approval for the study was given by the Health Research Authority and the North East Newcastle, North Tyneside 2 Regional Ethics Committee (reference 18/NE/0144) and Teesside University (reference 176/17). Findings will be disseminated through peer-reviewed journals and presentation at relevant patient groups, and local, national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03791164; Pre -results.",2019,"This study aims to investigate the effectiveness of the Pain Toolkit in comparison with a simple education control for people with low back pain.
","['people with persistent pain', 'people with low back pain', 'Participants who have been discharged from the North of England Regional Back Pain Pathway']","['Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group', 'pain toolkit', 'Pain Toolkit']","['disability (Oswestry Disability Index (ODI', 'pain (0-10 numerical scale), healthcare use (number of healthcare professional visits) and quality of life (EuroQol-5D']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}]",,0.257482,"This study aims to investigate the effectiveness of the Pain Toolkit in comparison with a simple education control for people with low back pain.
","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Findley', 'Affiliation': 'NHS Durham Dales Easington and Sedgefield Clinical Commissioning Group, Sedgefield, UK K0400937@live.tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cartwright', 'Affiliation': 'NHS Durham Dales Easington and Sedgefield Clinical Commissioning Group, Sedgefield, UK.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031266']
601,31738669,The effects of unknown additional eccentric loading on bench-press kinematics and muscle activation in professional handball and rugby players.,"Abstract  This study aimed to investigate the influence of unknown additional eccentric loading on bench-press kinematics (peak velocity, peak acceleration and accelerative percentage of the concentric phase) and muscle activation (pectoralis major and anterior deltoid) in professional rugby and handball players. Seventeen professional athletes were randomly assigned to complete three separate bench-press repetitions with different AEL schemes (100/40%, 100/60% and 100/80% of 1RM eccentric/concentric loading, respectively) under two conditions: known- and unknown-concentric load (KL and UL, respectively). Results indicate that the lack of knowledge regarding the additional eccentric load induced a significant increase in peak acceleration and agonist-muscles electromyographic activity, with no changes regarding peak velocity or accelerative percentage during the concentric phase. These results support the use of unknown loads as a practical strategy in eliciting rapid muscle activation and force production, which is critical in many sports, such as handball or rugby.",2020,"Results indicate that the lack of knowledge regarding the additional eccentric load induced a significant increase in peak acceleration and agonist-muscles electromyographic activity, with no changes regarding peak velocity or accelerative percentage during the concentric phase.","['professional rugby and handball players', 'professional handball and rugby players', 'Seventeen professional athletes']","['unknown additional eccentric loading (AEL', '1RM eccentric/concentric loading, respectively) under two conditions: known- and unknown- concentric load (KL and UL, respectively']","['bench-press kinematics (peak velocity, peak acceleration and accelerative percentage of the concentric phase) and muscle activation (pectoralis major and anterior deltoid', 'peak acceleration and agonist-muscles electromyographic activity']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",17.0,0.0238968,"Results indicate that the lack of knowledge regarding the additional eccentric load induced a significant increase in peak acceleration and agonist-muscles electromyographic activity, with no changes regarding peak velocity or accelerative percentage during the concentric phase.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'García-López', 'Affiliation': 'Department of Health Sciences, European University Miguel de Cervantes, Valladolid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Maroto-Izquierdo', 'Affiliation': 'IBIOMED, University of León, Leon, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Zarzuela', 'Affiliation': 'Department of Health Sciences, European University Miguel de Cervantes, Valladolid, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martín-Santana', 'Affiliation': 'World Cycling Centre, Union Cycliste Internationale, Aigle, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Antón', 'Affiliation': 'Department of Health Sciences, European University Miguel de Cervantes, Valladolid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sedano', 'Affiliation': 'Department of Health Sciences, European University Miguel de Cervantes, Valladolid, Spain.'}]",European journal of sport science,['10.1080/17461391.2019.1694587']
602,31585702,Which hospitalized smokers receive a prescription for quit-smoking medication at discharge? A secondary analysis of a smoking cessation randomized clinical trial.,"OBJECTIVE


To determine the prevalence and predictors of receiving a smoking cessation medication prescription at discharge.
METHODS


Retrospective analysis of ongoing Human Studies Committee-approved clinical trial data at large tertiary care center, The University of Kansas Medical Center. Patients included were smokers over 18, either Spanish or English speaking, those admitted between October 1, 2016 through May 31, 2018. Other eligibility criteria include access to a telephone or mobile phone, not currently be pregnant or breastfeeding, have no significant co-morbidity that precludes participation (acute, life-threatening illness, and communication barriers such as tracheal tube or altered mental status). Those included in this analysis were those randomized into the trial who expressed interest in receiving a smoking cessation medication prescription at discharge.
RESULTS


Two hundred fourteen patients were recommended a prescription by their smoking cessation counselor, 88 patients (41.12%) were approved a prescription at discharge. Out of those approved, 50.70 (14.05 SD) was the average age, 12.84 (8.47 SD) was the average number of cigarettes used per day, 47 patients (53.41%) were White, 49 patients (55.68%) were admitted through the emergency department, 55 patients (62.50%) had used smoking cessation medication in the past, 49 patients (55.68%) had used inpatient smoking cessation, 36 patients (40.91%) had Medicaid. A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
CONCLUSION


It was determined that among the population recommended for medication, 41.12% actually received a prescription at discharge. The variables of ""health insurance status"" and ""use of inpatient smoking cessation medication"" demonstrated to be predictors of receiving a prescription. It is important to further study this as many patients rely on a prescription to afford these medications that are useful in a quit attempt.",2019,"A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
","['Two hundred fourteen patients were recommended a prescription by their smoking cessation counselor, 88 patients (41.12%) were approved a prescription at discharge', 'Patients included were smokers over 18, either Spanish or English speaking, those admitted between October 1, 2016 through May 31, 2018', 'Retrospective analysis of ongoing Human Studies Committee-approved clinical trial data at large tertiary care center, The University of Kansas Medical Center', 'Out of those approved, 50.70 (14.05 SD) was the average age, 12.84 (8.47 SD) was the average number of cigarettes used per day, 47 patients (53.41%) were White, 49 patients (55.68%) were admitted through the emergency department, 55 patients (62.50%) had used smoking cessation medication in the past, 49 patients (55.68%) had used inpatient smoking cessation, 36 patients (40.91%) had Medicaid']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}]",[],[],214.0,0.0332641,"A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
","[{'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Mussulman', 'Affiliation': ''}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': ''}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.08.010']
603,31799996,Effect of Topical Brimonidine on Alcohol-Induced Flushing in Asian Individuals: A Randomized Clinical Trial.,"Importance


Alcohol flushing syndrome (AFS, also known as Asian glow and Asian flush) affects 20% to 47% of East Asians and causes significant psychosocial distress. There are no approved treatments for this condition.
Objective


To determine whether brimonidine gel, 0.33%, decreases facial erythema in patients with AFS after consumption of alcohol.
Design, Setting, and Participants


In this randomized clinical trial, 20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019.
Interventions


Participants were randomized to application of brimonidine gel to either the left or right half of their face. Placebo control was applied to the opposite side. After 30 minutes, participants ingested alcohol.
Main Outcomes and Measures


Outcomes were specified before data collection. The difference in erythema between the treated and placebo side of each participant's face was measured 60 minutes after drug application (primary outcome) and at 90 and 120 minutes after drug application (secondary outcomes). Participants were asked to rate their likelihood of using the medication again and their likelihood of recommending the medication to a friend on a scale of 0 to 10.
Results


The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50%). There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001). This effect persisted at 90 and 120 minutes. Individuals were likely to use the medication again (7.2; 95% CI, 6.0-8.3) and would also recommend it to a friend (7.6; 95% CI, 6.5-8.6).
Conclusions and Relevance


This study demonstrates that brimonidine gel is effective in reducing the facial erythema of AFS. Patients with psychosocial distress due to AFS may benefit from treatment with brimonidine.
Trial Registration


ClinicalTrials.gov identifier: NCT03497442.",2020,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","['patients with AFS after consumption of alcohol', '20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019', 'Asian Individuals', 'Patients with psychosocial distress', 'The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50']","['Topical Brimonidine', 'brimonidine gel', 'brimonidine', 'Placebo']","['Clinician Erythema Assessment score', 'facial erythema of AFS', 'erythema', 'Subject Self-Assessment score', 'facial erythema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",20.0,0.0595844,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","[{'ForeName': 'Wesley Y', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'University of California School of Medicine, San Francisco.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Aroyan', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Shinkai', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kieron S', 'Initials': 'KS', 'LastName': 'Leslie', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Lindy P', 'Initials': 'LP', 'LastName': 'Fox', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Siegrid', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Roy C', 'Initials': 'RC', 'LastName': 'Grekin', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Arron', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3508']
604,31694849,"Effect of mobile phone text message reminders on improving completeness and timeliness of routine childhood vaccinations in North-West, Ethiopia: a study protocol for randomised controlled trial.","INTRODUCTION


Non-attendance and delay in vaccination schedules remain a big challenge to healthcare workers. With the continuous growth of mobile network coverage and exponential penetration of mobile devices in the developing world, adoption of short message service has been shown to increase attendance for health services by targeting participant characteristics such as forgetfulness. Therefore, the aim of this trial is to determine the effect of mobile text message reminders on completeness and timeliness of childhood vaccination in North-West, Ethiopia.
METHODS AND ANALYSIS


A two-arm, parallel, superiority, randomised controlled trial study will be employed. The study arms are the intervention group (text message reminders plus routine care) and the control group (routine care only). Mother-infant pairs will be randomised to one of the groups during enrolment. The trial will consider a sample size of 434 mother-infant pairs with 1:1 allocation ratio. Mothers assigned to the intervention group will receive text message reminder 1 day before the scheduled vaccination visit at 6 weeks, 10 weeks, 14 weeks and at 9 months. Initially, descriptive statistics will be computed. For the primary outcome log-binomial regression model will be used to identify associated factors, and relative risk with 95% CI will be reported. Primarily, iIntention-to-treat analysis principle will be applied. STATA V.14 software will be used for the analysis.
ETHICS AND DISSEMINATION


This study obtained ethical approval from the University of Gondar Institutional Ethical Review Board. The trial findings on the effectiveness of mobile text message reminders in improving vaccination uptake will help to inform decision makers on the use of mobile health interventions in developing countries like Ethiopia. The scientific findings of the trial will also be published in reputable journals.
TRIAL REGISTRATION NUMBER


PACTR201901533237287.",2019,The study arms are the intervention group (text message reminders plus routine care) and the control group (routine care only).,"['434 mother-infant pairs with 1:1 allocation ratio', 'childhood vaccination in North-West, Ethiopia', 'North-West, Ethiopia']","['mobile text message reminders', 'intervention group (text message reminders plus routine care) and the control group (routine care only', 'mobile phone text message reminders']",['completeness and timeliness of routine childhood vaccinations'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",434.0,0.293295,The study arms are the intervention group (text message reminders plus routine care) and the control group (routine care only).,"[{'ForeName': 'Zeleke Abebaw', 'Initials': 'ZA', 'LastName': 'Mekonnen', 'Affiliation': 'Health Informatics, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia zelekeabebaw7@gmail.com.'}, {'ForeName': 'Binyam', 'Initials': 'B', 'LastName': 'Tilahun', 'Affiliation': 'Health Informatics, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Kassahun', 'Initials': 'K', 'LastName': 'Alemu', 'Affiliation': 'Institute of Public Health, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Were', 'Affiliation': 'Institute of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",BMJ open,['10.1136/bmjopen-2019-031254']
605,31719087,Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial.,"INTRODUCTION


Effective approaches to increase engagement in treatment for opioid use disorder (OUD) and reduce the risk of recurrent overdose and death following emergency department (ED) presentation for opioid overdose remain unknown. As such, we aim to compare the effectiveness of behavioural interventions delivered in the ED by certified peer recovery support specialists relative to those delivered by licensed clinical social workers (LCSWs) in promoting OUD treatment uptake and reducing recurrent ED visits for opioid overdose.
METHODS AND ANALYSIS


Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD) (n=650) will be recruited from two EDs in a single healthcare system in Providence, Rhode Island into a two-arm randomised trial with 18 months of follow-up postrandomisation. Eligible participants will be randomly assigned (1:1) in the ED to receive a behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW. The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
ETHICS AND DISSEMINATION


This protocol was approved by the Rhode Island Hospital institutional review board (Approval Number: 212418). Data will be presented at national and international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03684681.",2019,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","['individuals at high risk for opioid overdose', 'Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD', 'Eligible participants']","['behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW', 'emergency department-based peer recovery support intervention', 'behavioural interventions']","['engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}]",,0.120482,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Samuels', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Brinkman', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Dettor', 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Mahoney', 'Affiliation': 'Rhode Island Department of Behavioral Healthcare Developmental Disabilities and Hospitals, Cranston, Rhode Island, USA.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nizami', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': ""O'Toole"", 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Yedinak', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Beaudoin', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA Francesca_Beaudoin@brown.edu.'}]",BMJ open,['10.1136/bmjopen-2019-032052']
606,31719096,"Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D).","INTRODUCTION


Transition from paediatric to adult care is challenging for adolescents and emerging adults (ages 18 to 30 years) with type 1 diabetes (T1D). This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications. However, evidence to guide delivery of transition care is lacking. Given the effectiveness of group education in adult diabetes glycaemic control and improvements in qualitative measures in paediatric diabetes, group education is a potentially feasible and cost-effective alternative for the delivery of transition care. In emerging adults with T1D, we aim to assess the effectiveness of group education visits compared with usual care on HbA1c, T1D-related complications, psychosocial measures and cost-effectiveness after the transfer to adult care.
METHODS AND ANALYSIS


In a multisite, assessor-blinded, randomised, two-arm, parallel-group, superiority trial, 212 adolescents with T1D (ages 17 years) are randomised to 12 months group education versus usual T1D care before transfer to adult care. Visits in the active arm consist of group education sessions followed by usual T1D care visits every 3 months. Primary outcome is change in HbA1c measured at 24 months. Secondary outcomes are delays in establishing adult diabetes care, T1D-related hospitalisations and emergency department visits, severe hypoglycaemia, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, quality of life and cost-effectiveness at 12 and 24 months follow-up. Analysis will be by intention-to-treat. Change in HbA1c will be calculated and compared between arms using differences (95% CI), along with cost-effectiveness analysis. A similar approach will be conducted to examine between-arm differences in secondary outcomes.
ETHICS AND DISSEMINATION


The study was approved by McGill University Health Centre Research Ethics Board (GET-IT/MP-37-2019-4434, version 'Final 1.0 from November 2018). Study results will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03703440.",2019,"This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications.","['adolescents and emerging adults (ages 18 to 30 years) with type 1 diabetes (T1D', 'adolescents with type 1 diabetes during transition from paediatric to adult care', '212 adolescents with T1D (ages 17 years']",['12\u2009months group education versus usual T1D care before transfer to adult care'],"['delays in establishing adult diabetes care, T1D-related hospitalisations and emergency department visits, severe hypoglycaemia, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, quality of life and cost-effectiveness', 'glycaemic control (haemoglobin A1c (HbA1c', 'change in HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1171177', 'cui_str': 'Adult health care'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}]","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",212.0,0.155879,"This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Mok', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire Sainte-Justine, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Québec, Canada.'}, {'ForeName': 'Kaberi', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahme', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hajizadeh', 'Affiliation': 'School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Pediatrics, Nephrology, McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Prevost', 'Affiliation': 'Pediatrics, Endocrinology, McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frei', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Meranda', 'Initials': 'M', 'LastName': 'Nakhla', 'Affiliation': 'Pediatrics, Endocrinology, McGill University Health Centre, Montreal, Québec, Canada meranda.nakhla@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2019-033806']
607,31228197,Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Volunteering has consistently been associated with better mental, physical, and cognitive health in older adulthood. However, the volunteering rate of older adults in Hong Kong is much lower than in Western countries. Few studies have examined whether interventions can be effective in motivating older adults to volunteer in Hong Kong. To fill this gap, we conducted a randomized controlled trial to examine the impact of a theory-based social-cognitive intervention on volunteering.
RESEARCH DESIGN AND METHODS


A total of 264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage = 6.90 years, 81.06% female) were randomly assigned to either an experimental group or an active control group. Participants in the experimental group received 4 weekly 1-hr face-to-face volunteering intervention sessions. Those in the active control group received parallel sessions targeting physical activity instead of volunteering. The time spent on volunteering per month was self-reported and measured at baseline, 6 weeks, 3 months, and 6 months after the intervention. Self-efficacy, intention, action planning, and self-monitoring of volunteering were measured as mediators.
RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups. Self-efficacy, intention, and action planning consistently mediated the effect of the intervention on volunteering minutes.
DISCUSSION AND IMPLICATIONS


The findings demonstrate the effectiveness of the intervention on volunteering behavior in older adults in Hong Kong through well-established behavior change techniques.",2020,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","['older adulthood', 'Older Adults in Hong Kong', 'motivating older adults to volunteer in Hong Kong', '6.90 years, 81.06% female', '264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage ', 'older adults']","['active control group', 'parallel sessions targeting physical activity instead of volunteering', 'theory-based social-cognitive intervention', '4 weekly 1-hr face-to-face volunteering intervention sessions']","['Self-efficacy, intention, action planning, and self-monitoring of volunteering', 'volunteering behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",264.0,0.0563992,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","[{'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Department of Psychology, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Alice Ming-Lin', 'Initials': 'AM', 'LastName': 'Chong', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong, China.'}, {'ForeName': 'Tianyuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Centre for Psychosocial Health, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Wolff', 'Affiliation': 'Department of Psychology, Friedrich-Alexander-University (FAU) Erlangen-Nuremberg, Institute of Psychogerontology, Nuremberg, Germany.'}, {'ForeName': 'Kee-Lee', 'Initials': 'KL', 'LastName': 'Chou', 'Affiliation': 'Department of Asian and Policy Studies, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}]",The Gerontologist,['10.1093/geront/gnz076']
608,31213079,Phenomapping of subgroups in hypertensive patients using unsupervised data-driven cluster analysis: An exploratory study of the SPRINT trial.,"BACKGROUND


Hypertensive patients are highly heterogeneous in cardiovascular prognosis and treatment responses. A better classification system with phenomapping of clinical features would be of greater value to identify patients at higher risk of developing cardiovascular outcomes and direct individual decision-making for antihypertensive treatment.
METHODS


An unsupervised, data-driven cluster analysis was performed for all baseline variables related to cardiovascular outcomes and treatment responses in subjects from the Systolic Blood Pressure Intervention Trial (SPRINT), in order to identify distinct subgroups with maximal within-group similarities and between-group differences. Cox regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) for cardiovascular outcomes and compare the effect of intensive antihypertensive treatment in different clusters.
RESULTS


Four replicable clusters of patients were identified: cluster 1 (index hypertensives); cluster 2 (chronic kidney disease hypertensives); cluster 3 (obese hypertensives) and cluster 4 (extra risky hypertensives). In terms of prognosis, individuals in cluster 4 had the highest risk of developing primary outcomes. In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
CONCLUSION


Using a data-driven approach, SPRINT subjects can be stratified into four phenotypically distinct subgroups with different profiles on cardiovascular prognoses and responses to intensive antihypertensive treatment. Of note, these results should be taken as hypothesis generating that warrant further validation in future prospective studies.",2019,"In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
","['Four replicable clusters of patients were identified: cluster 1 (index hypertensives); cluster 2 (chronic kidney disease hypertensives); cluster 3 (obese hypertensives) and cluster 4 (extra risky hypertensives', 'hypertensive patients', 'Hypertensive patients']",[],['risk of severe adverse effects'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0722798,"In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
","[{'ForeName': 'Da-Ya', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Nie', 'Affiliation': 'Guangdong Cardiovascular Institute, Guangdong Provincial Hospital, China.'}, {'ForeName': 'Li-Zhen', 'Initials': 'LZ', 'LastName': 'Liao', 'Affiliation': 'Department of Health, Guangdong Pharmaceutical University, China.'}, {'ForeName': 'Shao-Zhao', 'Initials': 'SZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiu-Ting', 'Initials': 'XT', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiang-Bin', 'Initials': 'XB', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhuang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xin-Xue', 'Initials': 'XX', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}]",European journal of preventive cardiology,['10.1177/2047487319856733']
609,31904841,Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms: A Qualitative Study.,"OBJECTIVE


Pain, anxiety, and depression commonly co-occur, can have reciprocal effects, and are associated with substantial disability and health care costs. However, few interventions target treatment of pain and mood disorders as a whole. The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment. The purpose of the current study is to better understand patients' perspectives on both intervention approaches, including intervention components, delivery, patient experiences, and patient outcomes.
DESIGN


Qualitative, semistructured interviews.
SETTING


A Veterans Affairs Medical Center.
SUBJECTS


Twenty-five patients were purposefully sampled from both study arms.
METHODS


Patients were interviewed about their experiences with pain and mood treatment, perceived benefits and changes, and experiences with the intervention model to which they were randomized. The constant comparison method guided analysis.
RESULTS


Pain was more important than mood for most participants. Participants described developing increased awareness of their symptoms, including connecting pain and mood, which enabled better management. Participants in the high-resource intervention described the added value of the study nurse in their symptom management.
CONCLUSIONS


Patients in a telecare intervention for chronic pain and mood symptoms learned to connect pain and mood and be more aware of their symptoms, enabling more effective symptom management. Patients in the high-resource intervention described the added benefits of a nurse who provided informational and motivational support. Implications for tradeoffs between resource intensity and patient outcomes are discussed.",2020,"The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment.","[""Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms"", 'Twenty-five patients were purposefully sampled from both study arms', 'Patients were interviewed about their experiences with pain and mood treatment, perceived benefits and changes, and experiences with the intervention model to which they were randomized', 'A Veterans Affairs Medical Center']","['high- vs low-resource approach', 'telecare intervention']",['pain and mood disorders'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]",25.0,0.0597644,"The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment.","[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Matthias', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McCalley', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz345']
610,31236689,Quality of life after catheter and minimally invasive surgical ablation of paroxysmal and early persistent atrial fibrillation: results from the SCALAF trial.,"AIMS


In the SCALAF trial, catheter-based pulmonary vein isolation (PVI) was as effective in long-term prevention of atrial fibrillation (AF) as minimally invasive thoracoscopic PVI and left atrial appendage ligation (MIPI). Catheter ablation (CA) resulted in significantly less major complications as compare to MIPI. We report quality of life (QOL) outcome in these patients.
METHODS


In this study, 52 patients with symptomatic paroxysmal or early persistent AF were randomized to either MIPI or CA. QOL was assessed at baseline, 3, 6, and 12 months follow-up using the SF-36 Health Survey Questionnaire. AF-related symptoms were quantified at each follow-up visit using the European Heart Rhythm Association (EHRA) score.
RESULTS


Median age was 57 years and 78% was male. Paroxysmal AF was present in 74%. At 3 months follow-up, physical role limitations (88.2 ± 29.5; versus 40.9 ± 44.0; P = 0.001, respectively) and bodily pain scores (95.5 ± 8.7; versus 76.0 ± 27.8; P = 0.021, respectively) were significantly higher after CA compared to MIPI, indicating less limitation in daily activity caused by physical problems and less pain after CA than after MIPI. AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups.
CONCLUSIONS


CA and MIPI ablation of AF both resulted in an improvement in several QOL measurements, although CA resulted in significantly less physical problems and bodily pain 3 months after treatment compared to MIPI.
CLINICAL TRIAL NUMBER


ClinicalTrials.gov identifier: NCT00703157.",2020,"AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups.
","['Median age was 57\xa0years and 78% was male', '52 patients with symptomatic paroxysmal or early persistent AF', 'paroxysmal and early persistent atrial fibrillation', 'patients']","['catheter-based pulmonary vein isolation (PVI', 'catheter and minimally invasive surgical ablation', 'MIPI or CA', 'Catheter ablation (CA']","['QOL', 'quality of life (QOL) outcome', 'pain', 'Quality of life', 'several QOL measurements', 'bodily pain scores', 'EHRA scores', 'physical problems and bodily pain', 'Paroxysmal AF']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}]","[{'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]",52.0,0.120657,"AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups.
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Buist', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Rypko J', 'Initials': 'RJ', 'LastName': 'Beukema', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Jaap Jan J', 'Initials': 'JJJ', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Peter Paul H M', 'Initials': 'PPHM', 'LastName': 'Delnoy', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Martin E W', 'Initials': 'MEW', 'LastName': 'Hemels', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Hauw T', 'Initials': 'HT', 'LastName': 'Sie', 'Affiliation': 'Department of Cardiothoracic Surgery, Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Ramdat Misier', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands. v.r.c.derks@isala.nl.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-019-01504-z']
611,31227585,Effects of Exercise in Addition to a Family-Based Lifestyle Intervention Program on Hepatic Fat in Children With Overweight.,"OBJECTIVE


Pediatric hepatic steatosis is highly prevalent and closely related to type 2 diabetes. This study aimed to determine whether the addition of supervised exercise to a family-based lifestyle and psycho-educational intervention results in greater reduction of percentage of hepatic fat (HF), adiposity, and cardiometabolic risk factors in children with overweight/obesity.
RESEARCH DESIGN AND METHODS


The study subjects of this nonrandomized, two-arm, parallel design clinical trial were 116 overweight/obese children (10.6 ± 1.1 years of age, 53.4% girls) living in Vitoria-Gasteiz (Spain). For 22 weeks, they followed either a lifestyle and psycho-education program (control intervention [CInt],  N  = 57), consisting of two family-based education sessions/month, or the same plus supervised exercise (intensive intervention [II],  N  = 59) focused mainly on high-intensity aerobic workouts (3 sessions/week, 90 min/session). The primary outcome was the change in percentage of HF (as measured by MRI) between baseline and the end of the intervention period. Secondary outcomes included changes in BMI, fat mass index (FMI), abdominal fat (measured by DEXA), blood pressure, triglycerides, HDL, LDL, γ-glutamyl transferase, glucose, and insulin concentrations.
RESULTS


A total of 102 children completed the trial ( N  = 53 and  N  = 49 in the CInt and II groups, respectively). Percentage of HF decreased only in the II group (-1.20 ± 0.31% vs. 0.04 ± 0.30%, II and CInt groups, respectively), regardless of baseline value and any change in adiposity ( P  < 0.01). BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
CONCLUSIONS


Multicomponent intervention programs that include exercise training may help to reduce adiposity, insulin resistance, and hepatic steatosis in overweight/obese children.",2020,"BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
","['Children With Overweight', 'overweight/obese children', '116 overweight/obese children (10.6 ± 1.1 years of age, 53.4% girls) living in Vitoria-Gasteiz (Spain', '102 children completed the trial ( N  = 53 and  N  = 49 in the CInt and II groups, respectively', 'children with overweight/obesity']","['exercise training', 'Family-Based Lifestyle Intervention Program', 'supervised exercise to a family-based lifestyle and psycho-educational intervention', 'Exercise', 'lifestyle- and psycho-education program (control intervention [CInt],  N  = 57), consisting of two family-based education sessions/month, or the same plus supervised exercise (intensive intervention [II],  N  = 59) focused mainly on high-intensity aerobic workouts']","['adiposity, insulin resistance, and hepatic steatosis', 'Percentage of HF', 'adiposity', 'changes in BMI, fat mass index (FMI), abdominal fat (measured by DEXA), blood pressure, triglycerides, HDL, LDL, γ-glutamyl-transferase, glucose, and insulin concentrations', 'percentage of hepatic fat (HF), adiposity, and cardiometabolic risk factors', 'BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin', 'change in percentage of HF (as measured by MRI', 'Hepatic Fat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",116.0,0.0728099,"BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
","[{'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain idoia.labayen@unavarra.es.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Medrano', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Lide', 'Initials': 'L', 'LastName': 'Arenaza', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Maíz', 'Affiliation': 'University of the Basque Country, Donostia, Spain.'}, {'ForeName': 'Maddi', 'Initials': 'M', 'LastName': 'Osés', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martínez-Vizcaíno', 'Affiliation': 'Health and Social Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Department of Physical and Sports Education, Faculty of Sports Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Department of Physical and Sports Education, Faculty of Sports Sciences, University of Granada, Granada, Spain.'}]",Diabetes care,['10.2337/dc19-0351']
612,31219315,A feasibility randomised controlled trial to evaluate the role of computed tomography in adults with atypical right iliac fossa pain.,"BACKGROUND


In patients with right iliac fossa pain, the need for surgery is largely determined by the likelihood of appendicitis. Patients often undergo ultrasound scanning despite a low diagnostic accuracy for appendicitis. This study aimed to determine the feasibility of a larger trial of computed tomography in the evaluation of patients with atypical right iliac fossa pain.
MATERIALS AND METHODS


A single-centre, unblinded, parallel randomised controlled trial of computed tomography in the assessment of patients with atypical right iliac fossa pain. After a retrospective evaluation, standard care was defined as serial examination with or without ultrasound. Atypical right iliac fossa pain was defined as no firm diagnosis after initial senior review. Simple descriptions of the risks and benefits of computed tomography were devised for patients to consider. Primary objectives were to assess feasibility and acceptability of the study procedures.
RESULTS


A total of 71 patients were invited to participate and 68 were randomised. Final analysis included 31 participants in the standard care arm and 33 in the computed tomography arm, with comparable demographics. Computed tomography was associated with superior diagnostic accuracy, with 100% positive and negative predictive value. The proportion of scans that positively influenced management was 73% for computed tomography and 0% for ultrasound. In the computed tomography arm, there was a trend towards a shorter length of stay (2.3 vs 3.1 days) and a lower negative laparoscopy rate (2 of 11 vs 4 of 9).
CONCLUSION


A large randomised trial to evaluate the use of unenhanced computed tomography in atypical right iliac fossa pain appears feasible and justified.",2019,"Computed tomography was associated with superior diagnostic accuracy, with 100% positive and negative predictive value.","['patients with right iliac fossa pain', 'A total of 71 patients were invited to participate and 68 were randomised', '31 participants in the standard care arm and 33 in the computed tomography arm, with comparable demographics', 'patients with atypical right iliac fossa pain', 'adults with atypical right iliac fossa pain']","['ultrasound scanning', 'unenhanced computed tomography', 'computed tomography']","['Atypical right iliac fossa pain', 'feasibility and acceptability of the study procedures', 'negative laparoscopy rate', 'shorter length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0476306', 'cui_str': 'Right iliac fossa pain (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0476306', 'cui_str': 'Right iliac fossa pain (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",71.0,0.105751,"Computed tomography was associated with superior diagnostic accuracy, with 100% positive and negative predictive value.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Department of General Surgery, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olatunbode', 'Affiliation': 'Department of General Surgery, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dean', 'Affiliation': 'Department of Radiology, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hall', 'Affiliation': 'Department of Radiology, South Tyneside District Hospital, South Tyneside, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Harji', 'Affiliation': 'Northern Surgical Trainees Research Association, Newcastle, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': 'Department of General Surgery, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Ish', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Rehaan', 'Initials': 'R', 'LastName': 'Ansari', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bookless', 'Affiliation': ''}, {'ForeName': 'Nnaemeka', 'Initials': 'N', 'LastName': 'Chidumije', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Duffin', 'Affiliation': ''}, {'ForeName': 'Nehemiah', 'Initials': 'N', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Firescu', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Grainge', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Harbit', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hollingsworth', 'Affiliation': ''}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Imam', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Keast', 'Affiliation': ''}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mbarushimana', 'Affiliation': ''}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McElnay', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mellen', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Chakri', 'Initials': 'C', 'LastName': 'Munipalle', 'Affiliation': ''}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Musbahi', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Norton', 'Affiliation': ''}, {'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Omar', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Teo', 'Affiliation': ''}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ''}]",Annals of the Royal College of Surgeons of England,['10.1308/rcsann.2019.0077']
613,31779603,Assessing the effectiveness of training models for national scale-up of an evidence-based nutrition and physical activity intervention: a group randomized trial.,"BACKGROUND


There is a great need to identify implementation strategies to successfully scale-up public health interventions in order to achieve their intended population impact. The Out-of-school Nutrition and Physical Activity group-randomized trial previously demonstrated improvements in children's vigorous physical activity and the healthfulness of foods and beverages consumed. This implementation study aimed to assess the effects and costs of two training models to scale-up this evidence-based intervention.
METHODS


A 3-arm group-randomized trial was conducted to compare effectiveness of in-person and online training models for scaling up the intervention compared to controls. One-third of sites were randomized to the in-person train-the-trainer model: local YMCA facilitators attended a training session and then conducted three learning collaborative meetings and technical assistance. One-third were assigned to the online model, consisting of self-paced monthly learning modules, videos, quizzes, and facilitated discussion boards. Remaining sites served as controls. Fifty-three afterschool sites from three YMCA Associations in different regions of the country completed baseline and follow-up observations using a validated tool of afterschool nutrition and physical activity practices. We used multivariable regression models, accounting for clustering of observations, to assess intervention effects on an aggregate afterschool practice primary outcome, and conducted secondary analyses of nine intervention goals (e.g. serving water). Cost data were collected to determine the resources to implement each training model.
RESULTS


Changes in the primary outcome indicate that, on average, sites in the in-person arm achieved 0.44 additional goals compared to controls (95%CI 0.02, 0.86, p = 0.04). Increases in the number of additional goals achieved in sites in the online arm were not significantly greater than control sites (+ 0.28, 95% CI -0.18, 0.73, p = 0.24). Goal-specific improvements were observed for increasing water offered in the in-person arm and fruits and vegetables offered in the online arm. The cost per person trained was $678 for the in-person training model and $336 for the on-line training model.
CONCLUSIONS


This pilot trial presents promising findings on implementation strategies for scale-up. It validated the in-person training model as an effective approach. The less expensive online training may be a useful option for geographically disbursed sites where in-person training is challenging.
TRIAL REGISTRATION


Although this study does not report the results of a health care intervention on human subjects, it is a randomized trial and was therefore retrospectively registered in ClinicalTrials.gov on July 4, 2019 in accordance with the BMC guidelines to ensure the complete publication of all results (NCT04009304).",2019,"Increases in the number of additional goals achieved in sites in the online arm were not significantly greater than control sites (+ 0.28, 95% CI -0.18, 0.73, p = 0.24).",['human subjects'],"['evidence-based nutrition and physical activity intervention', 'health care intervention']",['number of additional goals'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0769579,"Increases in the number of additional goals achieved in sites in the online arm were not significantly greater than control sites (+ 0.28, 95% CI -0.18, 0.73, p = 0.24).","[{'ForeName': 'Rebekka M', 'Initials': 'RM', 'LastName': 'Lee', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA. rlee@hsph.harvard.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrett', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Daly', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Mozaffarian', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Giles', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}, {'ForeName': 'Angie L', 'Initials': 'AL', 'LastName': 'Cradock', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Gortmaker', 'Affiliation': 'Department of Social and Behavioral Sciences, Prevention Research Center on Nutrition and Physical Activity, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, 7th Floor, Boston, MA, 02115, USA.'}]",BMC public health,['10.1186/s12889-019-7902-y']
614,31473932,Influence of an Implementation Support Intervention on Barriers and Facilitators to Delivery of a Substance Use Prevention Program.,"Implementation support interventions have helped organizations implement programs with quality and obtain intended outcomes. For example, a recent randomized controlled trial called Preparing to Run Effective Programs (PREP) showed that an implementation support intervention called Getting To Outcomes (GTO) improved implementation of an evidence-based substance use prevention program (CHOICE) run in community-based settings. However, more information is needed on how these interventions affect organizational barriers and facilitators of implementation. This paper aims to identify differences in implementation facilitators and barriers in sites conducting a substance use prevention program with and without GTO. PREP is a cluster-randomized controlled trial testing GTO, a two-year implementation support intervention, in Boys & Girls Clubs. The trial compares 15 Boys & Girls Club sites implementing CHOICE (control group), a five-session evidence-based alcohol and drug prevention program, with 14 Boys & Girls Club sites implementing CHOICE supported by GTO (intervention group). All sites received CHOICE training. Intervention sites also received GTO manuals, training, and onsite technical assistance to help practitioners complete implementation best practices specified by GTO (i.e., GTO steps). During the first year, technical assistance providers helped the intervention group adopt, plan, and deliver CHOICE, and then evaluate and make quality improvements to CHOICE implementation using feedback reports summarizing their data. Following the second year of CHOICE and GTO implementation, all sites participated in semi-structured interviews to identify barriers and facilitators to CHOICE implementation using the Consolidated Framework for Implementation Research (CFIR). This paper assesses the extent to which these facilitators and barriers differed between intervention and control group. Intervention sites had significantly higher average ratings than control sites for two constructs from the CFIR process domain: planning and reflecting and evaluating. At the same time, intervention sites had significantly lower ratings on the culture and available resources constructs. Findings suggest that strong planning, evaluation, and reflection-likely improved with GTO support-can facilitate implementation even in the face of perceptions of a less desirable implementation climate. These findings highlight that implementation support, such as GTO, is likely to help low-resourced community-based organizations improve program delivery through a focus on implementation processes. TRIAL REGISTRATION: This project is registered at ClinicalTrials.gov with number NCT02135991 (URL: https://clinicaltrials.gov/show/NCT02135991). The trial was first registered May 12, 2014.",2019,Intervention sites had significantly higher average ratings than control sites for two constructs from the CFIR process domain: planning and reflecting and evaluating.,"['15 Boys & Girls Club sites implementing CHOICE (control group), a', 'Boys & Girls Clubs']","['PREP', 'five-session evidence-based alcohol and drug prevention program, with 14 Boys & Girls Club sites implementing CHOICE supported by GTO (intervention group', 'Implementation Support Intervention']",['average ratings'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0574447,Intervention sites had significantly higher average ratings than control sites for two constructs from the CFIR process domain: planning and reflecting and evaluating.,"[{'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Cannon', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA. cannon@rand.org.'}, {'ForeName': 'Marylou', 'Initials': 'M', 'LastName': 'Gilbert', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ebener', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Malone', 'Affiliation': 'Malone Quantitative, Durham, North Carolina, USA.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Reardon', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Joie', 'Initials': 'J', 'LastName': 'Acosta', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01037-x']
615,31763241,Effectiveness of Nasal Packing in Trans-septal Suturing Technique in Septoplasty: A Randomized Comparative Study.,"Nasal packing is routinely used after septoplasty, but there are patient factors for which its use needs to be reconsidered. Effectiveness of nasal packing in trans-septal suturing technique in septoplasty. Prospective, comparative study, patients submitted to septoplasty were randomized to receive or not nasal packing postoperatively. Comparison in postoperative status for pain, headache, discomfort in swallowing, epiphora, bleeding, infection and pain on pack removal are assessed. In all the patients trans-septal suturing technique was used. Study group has 60 patients. Two groups were made group A in whom nasal packing done post operatively with merocel, group B in whom nasal packing was not done, in both groups quilting sutures were applied on to the septum. There was pain in nose and headache in all the patients in group A. Other symptoms in group A were epiphora, discomfort in swallowing due to ear discomfort. In addition to these there is pain on removal of packs. Routine use of nasal packing can be avoided instead sutures can be placed over the septum, which benefits in improving pain and symptoms due to pack in the postoperative period.",2019,"There was pain in nose and headache in all the patients in group A. Other symptoms in group A were epiphora, discomfort in swallowing due to ear discomfort.","['trans-septal suturing technique in septoplasty', '60 patients', 'patients submitted to septoplasty', 'Trans-septal Suturing Technique in Septoplasty']","['Nasal Packing', 'nasal packing done post operatively with merocel, group B in whom nasal packing', 'nasal packing']","['pain, headache, discomfort in swallowing, epiphora, bleeding, infection and pain on pack removal', 'pain in nose and headache', 'epiphora, discomfort in swallowing due to ear discomfort']","[{'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0038968', 'cui_str': 'Suture Technics'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0948296', 'cui_str': 'Ear discomfort'}]",60.0,0.0177189,"There was pain in nose and headache in all the patients in group A. Other symptoms in group A were epiphora, discomfort in swallowing due to ear discomfort.","[{'ForeName': 'Kanak', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Ojha', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Gakhar', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Kataria', 'Affiliation': 'Department of Otorhinolaryngology, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-017-1111-8']
616,31763263,An Ayurvedic Management of Nasal Polyposis.,"A nasal polyp is a prolapsed pedunculated part of the oedematous mucosa of the nose or paranasal sinuses. It is inflammatory in origin and not a neoplastic (Bhargava in A short book of E.N.T. diseases. 9th edn. Usha Publication, [1]). This present study was aimed to treat Nasal polyposis with the drug administration through nasal as well as oral route. Total 61 patients were registered in three groups. Simple random sampling (alternate) method was adopted for the selection of the patients and selected patients were divided into 3 groups. Patients of Nasya Group and Nasya + Oral group received Ayurvedic treatment where as Controlled Group patients were treated with allopathic medicine. Duration of treatment was kept 3 months for Nasya Group and Nasya + Oral group, while 21 days for Controlled Group. Follow up was kept for 2 months at interval of 15 days each. Though all three groups showed significant improvement in subjective symptoms; Nasya Group and Nasya + Oral group showed better result in grading of Polyp.",2019,Though all three groups showed significant improvement in subjective symptoms; Nasya Group and Nasya + Oral group showed better result in grading of Polyp.,['Total 61 patients were registered in three groups'],"['allopathic medicine', 'Ayurvedic treatment']",['subjective symptoms'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",61.0,0.0151279,Though all three groups showed significant improvement in subjective symptoms; Nasya Group and Nasya + Oral group showed better result in grading of Polyp.,"[{'ForeName': 'Achyuta', 'Initials': 'A', 'LastName': 'Atara', 'Affiliation': '1Department of Shalakyatantra, Shree Gulabkunverba Ayurved Mahavidyalaya, Gujarat Ayurved University, Jamnagar, Gujarat 361 008 India.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Rajgopala', 'Affiliation': 'Department of Shalakyatantra, All India Institute of Ayurveda, New Delhi, 110076 India.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Pansara', 'Affiliation': 'Jamnagar, Gujarat 361 008 India.'}, {'ForeName': 'Hiten', 'Initials': 'H', 'LastName': 'Maniyar', 'Affiliation': '4M P Shah Medical College, Jamnagar, India.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Naria', 'Affiliation': '5Pharmacology Laboratory, Institute for Postgraduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat 361 008 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1278-7']
617,31483150,"Jogging and Practical-Duration Foam-Rolling Exercises and Range of Motion, Proprioception, and Vertical Jump in Athletes.","CONTEXT


Foam-rolling exercises are frequently included in warmups due to their benefits for increasing range of motion (ROM). However, their effects on proprioception and vertical jump have not been analyzed and therefore remain unclear. Moreover, the effects of performing practical-duration foam-rolling exercises after typical warmup exercises such as jogging are unknown.
OBJECTIVE


To analyze the effects of jogging and practical-duration foam-rolling exercises on the ROM, knee proprioception, and vertical jump of athletes.
DESIGN


Randomized controlled study.
SETTING


Sports laboratory and university track.
PATIENTS OR OTHER PARTICIPANTS


Thirty athletes were randomly classified into an experimental group (EG) or control group (CG).
INTERVENTION(S)


The EG performed 8-minute jogging and foam-rolling exercises. The CG performed 8-minute jogging.
MAIN OUTCOME MEASURE(S)


Knee flexion, hip extension, active knee extension, ankle dorsiflexion (ADF), knee-joint position sense, and countermovement jump (CMJ) were evaluated before the intervention (baseline), after (post 0 min), and 10 minutes later.
RESULTS


The EG exhibited higher values for ADF and CMJ at post 0 min (ADF:  P  < .001, d = 0.88; CMJ:  P  < .001, d = 0.52) and 10 minutes later (ADF:  P  = .014, d = 0.41; CMJ:  P  = .006, d = 0.22) compared with baseline. Although the CG also showed increased CMJ at post 0 min ( P  = .044, d = 0.21), the EG demonstrated a greater increase ( P  = .021, d = 0.97). No differences were found in the remaining ROM variables (knee flexion, hip extension, active knee extension:  P  values > .05). For knee-joint position sense, no differences were found ( P  > .05).
CONCLUSIONS


Combining jogging and practical-duration foam rolling may increase ADF and CMJ without affecting knee proprioception and hip or knee ROM. Jogging by itself may slightly increase ADF and CMJ, but the results were better and were maintained after 10 minutes when foam rolling was added.",2019,"The EG exhibited higher values for ADF and CMJ at post 0 min (ADF:  P  < .001, d = 0.88; CMJ:  P  < .001, d = 0.52) and 10 minutes later (ADF:  P  = .014, d = 0.41; CMJ:  P  = .006, d = 0.22) compared with baseline.","['Thirty athletes', 'Athletes', 'Sports laboratory and university track']","['Jogging and Practical-Duration Foam-Rolling Exercises and Range of Motion, Proprioception, and Vertical Jump', 'jogging and practical-duration foam-rolling exercises', 'control group (CG', '8-minute jogging and foam-rolling exercises']","['ADF and CMJ', 'Knee flexion, hip extension, active knee extension, ankle dorsiflexion (ADF), knee-joint position sense, and countermovement jump (CMJ', 'CMJ', 'remaining ROM variables (knee flexion, hip extension, active knee extension', 'ROM, knee proprioception, and vertical jump of athletes']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",30.0,0.0192088,"The EG exhibited higher values for ADF and CMJ at post 0 min (ADF:  P  < .001, d = 0.88; CMJ:  P  < .001, d = 0.52) and 10 minutes later (ADF:  P  = .014, d = 0.41; CMJ:  P  = .006, d = 0.22) compared with baseline.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Romero-Franco', 'Affiliation': 'Nursing and Physiotherapy Department, University of the Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Romero-Franco', 'Affiliation': 'Unicaja Jaén Athletic Club, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': 'Physical Activity and Sports Science Department, University Rey Juan Carlos, Madrid, Spain.'}]",Journal of athletic training,['10.4085/1062-6050-474-18']
618,31763257,Resolving Perplexity: Comparison of Endoscopic Dacryocystorhinostomy With and Without Stent.,"Endoscopic dacryocystorhinostomy (DCR) is an effective surgical procedure to treat nasolacrimal duct obstruction. This study was conducted with an aim of comparing the success rate between use of stent and without use of stent in endoscopic DCR. A prospective randomized study was conducted. Total 50 cases with signs of nasolacrimal duct blockage were included. The cases were randomly divided in two groups with 25 cases in each group. Group A cases underwent endoscopic DCR with stent and group B without stent. The follow up was till 12th week. Both subjective and objective outcomes were noted. By 12th week, only 8% cases had no relief of symptoms in group A while 92% cases of group A and all cases of group B had complete relief of symptoms. In objective outcome, by the 12th week, in group A 92% cases had full patency while in group B 100% cases had full patency. Overall complications in postoperative period were seen in 28% patients in group A and 12% patients in group B. In this study the surgical results of endoscopic DCR with or without stent came almost equal with no statistical difference in the success rate between stent group and non-stent group. Now that Endoscopic DCR without stent is equally effective and reduces cost, we recommend that the endoscopic DCR without stent should be preferred.",2019,In this study the surgical results of endoscopic DCR with or without stent came almost equal with no statistical difference in the success rate between stent group and non-stent group.,['Total 50 cases with signs of nasolacrimal duct blockage were included'],"['Endoscopic dacryocystorhinostomy (DCR', 'Endoscopic Dacryocystorhinostomy With and Without Stent', 'endoscopic DCR with stent and group B without stent']","['success rate', 'full patency', 'Overall complications', 'complete relief of symptoms', 'relief of symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0027437', 'cui_str': 'Tear Duct'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy (procedure)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0196119,In this study the surgical results of endoscopic DCR with or without stent came almost equal with no statistical difference in the success rate between stent group and non-stent group.,"[{'ForeName': 'Jasdeep', 'Initials': 'J', 'LastName': 'Monga', 'Affiliation': '1Department of ENT, SGT Medical College, Hospital & Research Institute, Budhera, Gurugram, 122505 India.'}, {'ForeName': 'Yojana', 'Initials': 'Y', 'LastName': 'Sharma', 'Affiliation': '2Department of ENT, Shree Krishna Hospital and Pramukhswami Medical College, Karamsad, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Mishra', 'Affiliation': '2Department of ENT, Shree Krishna Hospital and Pramukhswami Medical College, Karamsad, India.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'ENT Hospital, Doctor House, Anand, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-017-1241-z']
619,31763265,Comparison of Endoscopic Turbinoplasty Versus Conventional Partial Inferior Turbinectomy in Chronic Hypertrophic Rhinitis.,"To compare the benefits of endoscopic turbinoplasty and conventional partial inferior turbinectomyin terms of symptomatic relief of the post operative subjective and objective outcomes in patients with chronic hypertrophic rhinitis. A comparative longitudinal study was carried out over a period of 18 months. 60 cases were assigned randomly into two groups-group A (endoscopic turbinoplasty) and group B (conventional partial inferior turbinectomy) and post-operatively were followed up to 6 months to look for postoperative subjective and objective outcomes. Symptomatic improvement in nasal obstruction was found to be consistently better in group A patients at postoperative days 7 and 15, but both groups achieved comparable symptom relief at the third month. A statistically significant difference in SNOT 22 scores were observed between the two groups at all follow-ups. Relatively higher rates of post-operative morbidities were observed in group B at the 7th and 15th postoperative days. Endoscopic turbinoplasty may be better than conventional partial inferior turbinectomy in terms of improvement in nasal obstruction and decreased postoperative morbidity in the immediate postoperative period.",2019,Symptomatic improvement in nasal obstruction was found to be consistently better in group,"['patients with chronic hypertrophic rhinitis', '60 cases', 'Chronic Hypertrophic Rhinitis']","['group A (endoscopic turbinoplasty) and group B (conventional partial inferior turbinectomy', 'endoscopic turbinoplasty and conventional partial inferior turbinectomyin', 'Endoscopic Turbinoplasty Versus Conventional Partial Inferior Turbinectomy']","['postoperative morbidity', 'symptom relief', 'Symptomatic improvement in nasal obstruction', 'SNOT 22 scores', 'rates of post-operative morbidities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339799', 'cui_str': 'Chronic hypertrophic rhinitis (disorder)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.0179738,Symptomatic improvement in nasal obstruction was found to be consistently better in group,"[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kavin Kumar', 'Affiliation': 'Department of ENT, Mahatma Gandhi Medical College and Research Institute, Pondy-Cuddalore Main Road, Pillaiyarkuppam, Puducherry, 607 402 India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karthikeyan', 'Affiliation': 'Department of ENT, Mahatma Gandhi Medical College and Research Institute, Pondy-Cuddalore Main Road, Pillaiyarkuppam, Puducherry, 607 402 India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nirmal Coumare', 'Affiliation': 'Department of ENT, Mahatma Gandhi Medical College and Research Institute, Pondy-Cuddalore Main Road, Pillaiyarkuppam, Puducherry, 607 402 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1285-8']
620,16369107,Comprehensive health education combining hot spa bathing and lifestyle education in middle-aged and elderly women: one-year follow-up on randomized controlled trial of three- and six-month interventions.,"BACKGROUND


This study attempted to clarify the duration of effects of 3- and 6-month comprehensive health education programs based on hot spa bathing, lifestyle education and physical exercise for women at 1-year follow-up.
METHODS


We examined middle-aged and elderly women who were randomly divided into two groups and followed up them for one year. Spa programmers instructed subjects for one hour in lifestyle education and physical exercise and for one hour in a half bath (salt spring, temperature at 41.5 degrees C) once a week. The program for the 3-month group (n=19) was repeated in the 6-month group (n=14). The evaluation items were body mass index, PWC75%HRmax (by a bicycle ergometer as aerobic capacity), blood profiles (total cholesterol, HDL cholesterol, arteriosclerotic index, uric acid, and hemoglobin A1c), profile of mood states, self-rating depression scale, subjective happiness, pains in the knee and back, and active modification of lifestyle.
RESULTS


There were significant interactions between groups and response over time to aerobic capacity, hemoglobin A1c, back pain, vigor, fatigue and self-rating depression (respectively, p<0.05). Duration of effects was longer for the 6-month intervention than for the 3-month intervention.
CONCLUSIONS


Beneficial effects of 6-month intervention on hemoglobin A1c, aerobic capacity, pains in the back, vigor, fatigue and depression remained significant at the 1-year follow-up. Duration of effects was longer in the 6-month intervention than in the 3-month intervention.",2006,"There were significant interactions between groups and response over time to aerobic capacity, hemoglobin A1c, back pain, vigor, fatigue and self-rating depression (respectively, p<0.05).","['middle-aged and elderly women', 'women at 1-year follow-up']","['Comprehensive health education combining hot spa bathing and lifestyle education', 'Spa programmers instructed subjects for one hour in lifestyle education and physical exercise']","['response over time to aerobic capacity, hemoglobin A1c, back pain, vigor, fatigue and self-rating depression', 'hemoglobin A1c, aerobic capacity, pains in the back, vigor, fatigue and depression', 'Duration of effects', 'body mass index, PWC75%HRmax (by a bicycle ergometer as aerobic capacity), blood profiles (total cholesterol, HDL cholesterol, arteriosclerotic index, uric acid, and hemoglobin A1c), profile of mood states, self-rating depression scale, subjective happiness, pains in the knee and back, and active modification of lifestyle']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0018701'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer, device (physical object)'}, {'cui': 'C0005768'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",,0.0171405,"There were significant interactions between groups and response over time to aerobic capacity, hemoglobin A1c, back pain, vigor, fatigue and self-rating depression (respectively, p<0.05).","[{'ForeName': 'Hiroharu', 'Initials': 'H', 'LastName': 'Kamioka', 'Affiliation': 'Faculty of Regional Environment Science, Tokyo University of Agriculture, Japan. h1kamiok@nodai.ac.jp'}, {'ForeName': 'Yosikazu', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ''}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Yazaki', 'Affiliation': ''}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Uebaba', 'Affiliation': ''}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Mutoh', 'Affiliation': ''}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': ''}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ''}]",Journal of epidemiology,[]
621,31763286,Ivermectin: A Novel Method of Treatment of Nasal and Nasopharyngeal Myiasis.,"To evaluate the efficacy of oral Ivermectin, in patients suffering from nasal and nasopharyngeal myiasis. This was a prospective study, comprising 80 patients of nasal and nasopharyngeal myiasis. Patients underwent clinical examination and nasal endoscopy at the time of presentation and findings were recorded. The patients were randomly divided in two groups. In group-I the patients underwent manual extraction of the maggots after instillation of chloroform and turpentine oil mixture, whereas the group-II patients underwent manual extraction with administration of two doses (24 h apart) of oral Ivermectin (6 mg each). The patients were instructed to record the time when they noticed shedding of maggots, and evaluated for the clearance of maggots by endoscopy after 24, 48 h and 7 days after the initial examination. The mean maggot shedding time (by  t  test) in Group-I was 41.23 ± 4.23 h and in Group-II was 24.60 ± 3.15 h. The difference being highly significant statistically, ( p  = 0.0001). The endoscopic clearance of maggots (by Chi square test) between the two group of patients was also statistically significant at 24 and 48 h with  p  value of ( p  = 0.002) and ( p  = 0.006) respectively. Oral Ivermectin was effective in treating nasal and nasopharyngeal myiasis, in terms of early clearance, decreased morbidity and less hospital stay. We conclude that oral Ivermectin can be used as a safe and effective method for the treatment of nasal & nasopharyngeal myiasis.",2019,"Oral Ivermectin was effective in treating nasal and nasopharyngeal myiasis, in terms of early clearance, decreased morbidity and less hospital stay.","['80 patients of nasal and nasopharyngeal myiasis', 'patients suffering from nasal and nasopharyngeal myiasis']","['Ivermectin', 'oral Ivermectin', 'Oral Ivermectin', 'manual extraction of the maggots after instillation of chloroform and turpentine oil mixture']","['mean maggot shedding time', 'endoscopic clearance of maggots', 'morbidity and less hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0349002', 'cui_str': 'Nasopharyngeal myiasis'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0391874', 'cui_str': 'Manual extraction'}, {'cui': 'C0016386', 'cui_str': 'Maggots'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0008238', 'cui_str': 'Chloroform'}, {'cui': 'C0041411', 'cui_str': 'turpentine oil'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016386', 'cui_str': 'Maggots'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",80.0,0.0197542,"Oral Ivermectin was effective in treating nasal and nasopharyngeal myiasis, in terms of early clearance, decreased morbidity and less hospital stay.","[{'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Sayeed', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Sharma', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hasan', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP 202002 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-018-1444-y']
622,31179773,"Clinical evaluation of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis: a randomized, double-blind study.","Objective:  To assess the efficacy and safety of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis (RAS). Methods:  Seventy-two subjects with RAS were recruited to this randomized, parallel-controlled, double-blind clinical trial. The participants were randomly allocated to the test group or the control group. Demographic data were recorded at baseline. The use of the film was demonstrated. Pain score (visual analog scale), adverse effects, ulcer size were recorded on day 1 (baseline), day 2, day 4, and day 6. Results:  The reduction in ulcer size was significantly greater ( p <.05) in the treatment group (2.91 ± 3.66) than in the control group (1.10 ± 2.26) between days 4 and 6. There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05). No obvious adverse effects were observed. Conclusions:  The oral mucoadhesive film containing chitosan promotes oral ulcer healing and can be used as a drug carrier in treating oral ulcers. Trial registration number:  ChiCTR-IOR-16008970.",2020,"There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05).","['Methods:  Seventy-two subjects with RAS', 'recurrent aphthous stomatitis', 'recurrent aphthous stomatitis (RAS']",['oral mucoadhesive film containing chitosan'],"['pain score, ulcer size, or reduction in the pain score', 'adverse effects', 'Pain score (visual analog scale), adverse effects, ulcer size', 'reduction in ulcer size', 'efficacy and safety']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.135335,"There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05).","[{'ForeName': 'Yanxiong', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1610548']
623,31912141,Examining 1:1 vs. 4:1 Packed Red Blood Cell to Fresh Frozen Plasma Ratio Transfusion During Pediatric Burn Excision.,"Blood transfusions following major burn injury are common due to operative losses, blood sampling, and burn physiology. While massive transfusion improves outcomes in adult trauma patients, literature examining its effect in critically ill children is limited. The study purpose was to prospectively compare outcomes of major pediatric burns receiving a 1:1 vs. 4:1 packed red blood cell to fresh frozen plasma transfusion strategy during massive burn excision. Children with >20% total body surface area burns were randomized to a 1:1 or 4:1 packed red blood cell/fresh frozen plasma transfusion ratio during burn excision. Parameters examined include patient demographics, burn size, pediatric risk of mortality (PRISM) scores, pediatric logistic organ dysfunction scores, laboratory values, total blood products transfused, and the presence of blood stream infections or pneumonia. A total of 68 children who met inclusion criteria were randomized into two groups (n = 34). Mean age, PRISM scores, estimated blood loss (600 ml (400-1175 ml) vs. 600 ml (300-1150 ml), P = 0.68), ventilator days (5 vs. 9, P = 0.47), and length of stay (57 vs. 60 days, P = 0.24) had no difference. No differences in frequency of blood stream infection (20 vs. 18, P = 0.46) or pneumonia events (68 vs. 116, P = 0.08) were noted. On multivariate analysis, only total body surface area burn size, inhalation injury, and PRISM scores (P < 0.05) were significantly associated with infections.",2020,"On multivariate analysis, only TBSA burn size, inhalation injury, and PRISM scores (p < 0.05) were significantly associated with infections.","['Children with >20% total body surface area (TBSA) burns', 'major pediatric burns receiving a 1:1 vs 4:1 packed red blood cell (PRBC) to fresh frozen plasma (FFP) transfusion strategy during massive burn excision', '68 children who met inclusion criteria', 'adult trauma patients']",['Packed Red Blood Cell to Fresh Frozen Plasma Ratio Transfusion'],"['PRBC/FFP transfusion ratio', 'ventilator days', 'length of stay', 'TBSA burn size, inhalation injury, and PRISM scores', 'Blood transfusions', 'pneumonia events', 'Mean age, PRISM scores, estimated blood loss', 'frequency of blood stream infection', 'patient demographics, burn size, Pediatric Risk of Mortality (PRISM) scores, Pediatric Logistic Organ Dysfunction (PELOD) scores, laboratory values, total blood products transfused, and the presence of blood stream infections or pneumonia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0745334', 'cui_str': 'Injury to respiratory system due to inhaled substance (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0475502', 'cui_str': 'Pediatric risk of mortality (assessment scale)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C3494458', 'cui_str': 'Organ Dysfunction Scores'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",68.0,0.0691697,"On multivariate analysis, only TBSA burn size, inhalation injury, and PRISM scores (p < 0.05) were significantly associated with infections.","[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Tejiram', 'Affiliation': 'Shriners Hospitals for Children Northern California and the Firefighters Burn Institute Regional Burn Center, Department of Surgery, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Soman', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Shriners Hospitals for Children Northern California and the Firefighters Burn Institute Regional Burn Center, Department of Surgery, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Romanowski', 'Affiliation': 'Shriners Hospitals for Children Northern California and the Firefighters Burn Institute Regional Burn Center, Department of Surgery, University of California, Davis, Sacramento, California.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Greenhalgh', 'Affiliation': 'Shriners Hospitals for Children Northern California and the Firefighters Burn Institute Regional Burn Center, Department of Surgery, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Palmieri', 'Affiliation': 'Shriners Hospitals for Children Northern California and the Firefighters Burn Institute Regional Burn Center, Department of Surgery, University of California, Davis, Sacramento, California.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa001']
624,31563095,"The effects of a working memory load on drinking-related decisions: The role of incentives, disincentives, and lifetime alcohol problems.","BACKGROUND


This study extends this literature on effects of working memory (WM) load on impulsive and disadvantageous decision-making by investigating the impact of WM load on drinking-related decisions in different incentive and disincentive contexts in a large sample (n = 821, 373 women) of young adults, 558 of whom had an alcohol use disorder (AUD).
METHODS


Decisions to attend and drink at hypothetical party events that varied in terms of alcohol party incentives (high vs low) and next day responsibility disincentives (high vs moderate vs low) were assessed. Subjects were randomly assigned to either a WM load (n = 387) or no load condition (n = 434).
RESULTS


Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts. This effect was not found in the moderate or low disincentive contexts. Additionally, a WM load increased the effects of high alcohol party incentives on both decisions to attend and drink. The WM load also resulted in faster attendance decision reaction times, suggesting that subjects were more impulsive under load.
CONCLUSIONS


These results suggest that a WM load had a general effect of disrupting the decision-making process, reducing the inhibitory effects of high disincentives, amplifying the facilitating effects of high party incentives on alcohol-related decisions, and reducing decision deliberation times (reaction times). This suggests that individuals under significant cognitive load engage in more impulsive and riskier decisions when deciding to attend and drink at party events.",2019,"RESULTS


Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts.","['a large sample (n\u202f=\u202f821, 373 women) of young adults, 558 of whom had an alcohol use disorder (AUD']","['WM load (n\u202f=\u202f387) or no load condition', 'working memory (WM', 'working memory load']",['attendance decision reaction times'],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}]",373.0,0.0315715,"RESULTS


Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts.","[{'ForeName': 'Polly F', 'Initials': 'PF', 'LastName': 'Ingram', 'Affiliation': 'Department of Psychological and Brain Sciences, 1101 E 10th St, Indiana University, Bloomington, IN, 47405, United States.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Finn', 'Affiliation': 'Department of Psychological and Brain Sciences, 1101 E 10th St, Indiana University, Bloomington, IN, 47405, United States. Electronic address: finnp@indiana.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107567']
625,31753880,Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol.,"INTRODUCTION


Little is known about the applicability of mindfulness-based interventions in Spanish adults with overweight/obesity. The objective of the present study protocol is to describe the methods that will be used in a cluster randomised trial (CRT) that aims to evaluate the effectiveness of a mindfulness eating (ME) programme to reduce emotional eating (EE) in adults with overweight/obesity in primary care (PC) settings.
METHODS AND ANALYSIS


A CRT will be conducted with approximately 76 adults with overweight/obesity from four PC health centres (clusters) in the city of Zaragoza, Spain. Health centres matched to the average per capita income of the assigned population will be randomly allocated into two groups: 'ME +treatment as usual (TAU)' and 'TAU alone'. The ME programme will be composed of seven sessions delivered by a clinical psychologist, and TAU will be offered by general practitioners. The primary outcome will be EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ) at post test as primary endpoint. Other outcomes will be external and restrained eating (DEBQ), binge eating (Bulimic Investigatory Test Edinburgh), eating disorder (Eating Attitude Test), anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), mindful eating (Mindful Eating Scale), dispositional mindfulness (Five Facet Mindfulness Questionnaire) and self-compassion (Self-Compassion Scale). Anthropometric measures, vital signs and blood tests will be taken. A primary intention-to-treat analysis on EE will be conducted using linear mixed models. Supplementary analyses will include secondary outcomes and 1-year follow-up measures; adjusted models controlling for sex, weight status and levels of anxiety and depression; the complier average causal effect of treatment; and the clinical significance of improvements.
ETHICS AND DISSEMINATION


Positive results of this study may have a significant impact on one of the most important current health-related problems. Approval was obtained from the Ethics Committee of the Regional Authority. The results will be submitted to peer-reviewed journals, and reports will be sent to participants.
TRIAL REGISTRATION NUMBER


NCT03927534 (5/2019).",2019,The primary outcome will be EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ) at post test as primary endpoint.,"['adults with overweight/obesity in primary care (PC) settings', 'patients suffering from overweight or obesity in primary care settings', '76 adults with overweight/obesity from four PC health centres (clusters) in the city of Zaragoza, Spain', 'Spanish adults with overweight/obesity']","['mindful-eating programme', 'mindfulness eating (ME) programme', ""ME +treatment as usual (TAU)' and 'TAU alone""]","['emotional eating (EE', 'Anthropometric measures, vital signs and blood tests', 'EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ', 'emotional eating', 'sex, weight status and levels of anxiety and depression; the complier average causal effect of treatment; and the clinical significance of improvements', 'external and restrained eating (DEBQ), binge eating (Bulimic Investigatory Test Edinburgh), eating disorder (Eating Attitude Test), anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), mindful eating (Mindful Eating Scale), dispositional mindfulness (Five Facet Mindfulness Questionnaire) and self-compassion (Self-Compassion Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0518766'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0222045'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",76.0,0.129225,The primary outcome will be EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ) at post test as primary endpoint.,"[{'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Morillo Sarto', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barcelo-Soler', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Pantilie', 'Affiliation': 'Oral and Maxillofacial Surgery Department, Miguel Servet University Hospital, Zaragoza, Aragón, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain jmonteromarin@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-031327']
626,31748300,HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial.,"INTRODUCTION


Pharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
METHODS AND ANALYSIS


A large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).
ETHICS AND DISSEMINATION


Ethical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.
TRIAL REGISTRATION NUMBERS


ACTRN12618001799246p; NCT03907748.",2019,"Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
","['495 dyads from Australia, Germany, UK, Poland and Norway', 'people living with dementia']","['home-based family caregiver-delivered music and reading interventions', 'standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC', 'music therapy']","['BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire', 'relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C1868717', 'cui_str': 'BPSD'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",495.0,0.193686,"Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
","[{'ForeName': 'Felicity Anne', 'Initials': 'FA', 'LastName': 'Baker', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia felicity.baker@unimelb.edu.au.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Bloska', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bukowska', 'Affiliation': 'Department of Occupational Therapy, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Clark', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ming H', 'Initials': 'MH', 'LastName': 'Hsu', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Kvamme', 'Affiliation': 'Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Young-Eun Claire', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Smrokowska-Reichmann', 'Affiliation': 'Department of Occupational Therapy, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Tanara Vieira', 'Initials': 'TV', 'LastName': 'Sousa', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karette A', 'Initials': 'KA', 'LastName': 'Stensaeth', 'Affiliation': 'Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamplin', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wosch', 'Affiliation': 'Hochschule für angewandte Wissenschaften Würzburg-Schweinfurt, Würzburg, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Odell-Miller', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031332']
627,31298652,Effects of Short-Term Fasting and Different Overfeeding Diets on Thyroid Hormones in Healthy Humans.,"Background:  A greater decrease in 24-hour energy expenditure (EE) during fasting and a smaller increase in 24-hour EE during low-protein overfeeding (metabolic ""thrifty"" phenotype) predict weight gain. As thyroid hormones (TH) are implicated in energy intake and metabolism, we assessed whether: (i) TH concentrations are altered by 24-hour fasting or overfeeding diets with varying protein content and (ii) diet-related changes in TH correlate with concomitant changes in EE.  Methods:  Fifty-eight euthyroid healthy subjects with normal glucose regulation underwent 24-hour dietary interventions including fasting, eucaloric feeding, and five overfeeding diets in a crossover design within a whole-room indirect calorimeter to measure the 24-hour EE. Overfeeding diets (200% of energy requirements) included three diets with 20% protein, one diet with 3% protein (low-protein overfeeding diet [LPF]: 46% fat), and one diet with 30% protein (high-protein overfeeding diet [HPF]: 44% fat,  n  = 51). Plasma free thyroxine (fT4), free triiodothyronine (fT3), and fibroblast growth factor 21 (FGF21) concentrations were measured after overnight fast the morning of and after each diet.  Results:  On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13],  p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL [CI -0.27 to -0.07],  p  = 0.001) after 24-hour fasting, whereas both fT4 and fT3 decreased by 5% (-0.07 ng/dL [CI -0.11 to -0.04],  p  < 0.0001) and 4% (-0.14 pg/mL [CI -0.24 to -0.04],  p  = 0.008) following HPF, respectively. Greater decreases in fT3 after HPF are associated with larger decreases in FGF21 ( r  = 0.40,  p  = 0.005). Following LPF, the mean fT3 increased by 6% (+0.14 pg/mL [CI 0.05-0.2],  p  = 0.003) with no change in fT4 ( p  = 0.7). No changes in TH were observed after normal-protein overfeeding diets (all  p  > 0.1). No associations were observed between TH concentrations and diet-related changes in 24-hour EE during any diet (all  p  > 0.07).  Conclusions:  Acute (200%) short-term (24 hours) changes in food intake induce small changes in TH concentrations only after diets with low (0% fasting and 3% protein overfeeding) or high (30% protein overfeeding) protein content. The fT3-FGF21 association after high-protein overfeeding suggests a role for TH in inhibiting FGF21 secretion by the liver during protein excess. These results indicate that TH are involved in protein metabolism; however, they do not mediate the short-term EE response to diets that characterize the metabolic phenotypes and determine the individual susceptibility to weight gain.",2019,"On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13],  p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL","['Healthy Humans', 'Fifty-eight euthyroid healthy subjects with normal glucose regulation underwent']","['diets with 20% protein, one diet with 3% protein (low-protein overfeeding diet [LPF]: 46% fat), and one diet with 30% protein (high-protein overfeeding diet [HPF', 'Short-term Fasting and Different Overfeeding Diets', 'Overfeeding diets', '24-hour dietary interventions including fasting, eucaloric feeding, and five overfeeding diets']","['TH concentrations and diet-related changes in 24-hour EE', 'fT3', 'TH concentrations', '24-hour energy expenditure (EE', 'FGF21', '24-hour EE', 'mean fT3', 'TH', 'Plasma free thyroxine (fT4), free triiodothyronine (fT3), and fibroblast growth factor 21 (FGF21) concentrations', 'food intake']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine (substance)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",,0.0196795,"On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13],  p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL","[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Basolo', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Begaye', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hollstein', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Karyne L', 'Initials': 'KL', 'LastName': 'Vinales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Santini', 'Affiliation': 'Obesity Research Center, Endocrinology Unit, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0237']
628,30880522,The effect of patient-selected or preselected music on anxiety during cesarean delivery: a randomized controlled trial.,"Background:  Women undergoing cesarean delivery may have significant anxiety prior to surgery. Nonpharmacological approaches to anxiety reduction are favored in this patient population. Objective:  The aim of this study was to determine the effects of patient-selected or preselected music on anxiety in parturients undergoing scheduled cesarean delivery. Materials and methods:  This is a prospective, randomized controlled trial (IRB protocol #2015P002043; ClinicalTrials.gov, NCT02732964), of 150 parturients undergoing elective cesarean delivery. Parturients were randomized to patient-selected music (Pandora ® ), preselected music (Mozart), or no music (control). The primary outcome was anxiety after music exposure (versus no music) in the preoperative holding room. Secondary outcomes included postoperative anxiety, postoperative pain, and patient satisfaction. Results:  Baseline anxiety and anxiety following preoperative exposure did not differ in the Pandora versus control group (3.8 ± 2.4 versus 4.6 ± 2.6, mean difference -0.8 [95% CI -1.8 to 0.2],  p  = .12), but was lower in the Mozart group versus control group (3.5 ± 2.5 versus 4.6 ± 2.5, mean difference -1.1 [95% CI -2.2 to -0.1],  p  = .03). Postoperative anxiety did not differ in the Pandora versus control group (1.0 ± 1.4 versus 1.3 ± 2.0, mean difference -0.3 [95% CI -1.0 to 0.4],  p  = .43), or in the Mozart versus control group (0.8 ± 1.3 versus 1.3 ± 2.0, mean difference -0.5 [95% CI -1.2 to 0.2],  p  = .15). Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6 [95% CI -1.3 to 0.1],  p  = .10), but was lower in the Mozart versus control group (0.6 ± 1.3 versus 1.4 ± 1.9, mean difference -0.8 [95% CI -1.4 to -0.1],  p  = .03). Total patient satisfaction scores were not different among the control, Pandora, and Mozart groups. Conclusion:  While preselected Mozart music results in lower anxiety prior to cesarean delivery, patient-selected Pandora music does not. Further investigation to determine how music affects patients, clinicians, and the operating room environment during cesarean delivery is warranted. Clinical trial registration:  NCT02732964.",2020,"Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6","['patient-selected or preselected music on anxiety during cesarean delivery', '150 parturients undergoing elective cesarean delivery', 'parturients undergoing scheduled cesarean delivery']","['patient-selected music (Pandora ® ), preselected music (Mozart), or no music (control', 'patient-selected or preselected music']","['Baseline anxiety and anxiety', 'Postoperative pain', 'anxiety after music exposure (versus no music', 'Postoperative anxiety', 'Total patient satisfaction scores', 'postoperative anxiety, postoperative pain, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",150.0,0.271018,"Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6","[{'ForeName': 'Dan Michael', 'Initials': 'DM', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Mario Isaac', 'Initials': 'MI', 'LastName': 'Lumbreras-Marquez', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lawrence Ching', 'Initials': 'LC', 'LastName': 'Tsen', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'William Reid', 'Initials': 'WR', 'LastName': 'Camann', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michaela Kristina', 'Initials': 'MK', 'LastName': 'Farber', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1594766']
629,31142465,Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial.,"AIM


To determine if 'Defocus Incorporated Multiple Segments' (DIMS) spectacle lenses slow childhood myopia progression.
METHODS


A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8-13 years, with myopia between -1.00 and -5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.
RESULTS


160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were -0.41±0.06 D in the DIMS group and -0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p<0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses.
CONCLUSIONS


Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.
TRIAL REGISTRATION NUMBER


NCT02206217.",2020,"Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001).","['160 children completed the study, n=79 in the DIMS group and n=81 in the SV group', '183 Chinese children aged 8-13 years, with myopia between -1.00 and -5.00 D and astigmatism ≤1.50 D. Children']","['DIMS lens', 'wear DIMS (n=93) or single vision (SV) spectacle lenses']","['retarded myopia progression and axial elongation', 'Myopia', 'Refractive error (cycloplegic autorefraction) and axial length', 'axial elongation', 'myopia progression', 'Mean (SE) axial elongation']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}]","[{'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C1275648', 'cui_str': 'Single vision spectacles'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0521111', 'cui_str': 'Retarded (slowed) (contextual qualifier) (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegics'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",183.0,0.432733,"Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001).","[{'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong carly.lam@polyu.edu.hk.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Dennis Yan-Yin', 'Initials': 'DY', 'LastName': 'Tse', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Roger Pak Kin', 'Initials': 'RPK', 'LastName': 'Lee', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Rachel Ka Man', 'Initials': 'RKM', 'LastName': 'Chun', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatanaka', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313739']
630,31736608,"Role of intravenous zoledronic acid in management of giant cell tumor of bone- A prospective, randomized, clinical, radiological and electron microscopic analysis.","Background


The primary treatment of Giant cell tumor of bone is surgical management. Bisphosphonates are antiresorptive drugs which inhibit osteoclast mediated bone resorption and shown to have inhibitory effect on various tumors. The present study aims to establish clinical, ultrastructural and radiological response of intravenous zoledronic acid on giant cell tumor of bone.
Methodology


Design - Prospective randomized controlled study. A group of 30 patients of GCT bone were randomized into two equal groups. Patients in control group did not receive any adjuvant therapy before surgery. Patients in bisphosphonate group received three doses of intravenous zoledronic acid at four weeks interval prior to definitive surgery. The evaluation was done based on size of swelling, VAS score, plain radiograph, MRI and histopathological and Transmission electron microscopic examination findings.
Results


Significant reduction in VAS score (from mean 5.33 to 1.8), increased mineralization particularly at periphery of lesion in plain radiograph, statistically significant increase in mean apoptotic index, P value < 0.0001 (mean 41.46 in bisphosphonate group and 6.06 in control group) was noted in bisphosphonate group. No significant change in tumor volume is noted in MRI. No significant side effects were noted.
Discussion


One distinctive feature of pathogenesis of GCT bone is osteoclastogenesis which causes extensive bone destruction. Use of intravenous Zoledronic acid counteracts this bone destruction. Further, possible antiangiogenic effect of intravenous bisphosphonates inhibits tumor growth and provides symptomatic improvement.
Conclusion


IV Zoledronic acid alleviates pain, produce sclerosis and induce apoptosis hence decrease the rate of tumor progression and decrease the rate of local bone destruction, hence they are useful adjuvant to surgery in GCT.",2019,"Results


Significant reduction in VAS score (from mean 5.33 to 1.8), increased mineralization particularly at periphery of lesion in plain radiograph, statistically significant increase in mean apoptotic index, P value < 0.0001 (mean 41.46 in bisphosphonate group and 6.06 in control group) was noted in bisphosphonate group.",['30 patients of GCT bone'],"['Bisphosphonates', 'intravenous zoledronic acid', 'Zoledronic acid', 'bisphosphonate', 'zoledronic acid', 'bisphosphonates']","['tumor volume', 'MRI', 'side effects', 'size of swelling, VAS score, plain radiograph, MRI and histopathological and Transmission electron microscopic examination findings', 'rate of local bone destruction', 'mean apoptotic index', 'VAS score', 'giant cell tumor of bone']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}]","[{'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0013852', 'cui_str': 'Negatrons'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0206638', 'cui_str': 'Giant Cell Tumor of Bone'}]",,0.0445647,"Results


Significant reduction in VAS score (from mean 5.33 to 1.8), increased mineralization particularly at periphery of lesion in plain radiograph, statistically significant increase in mean apoptotic index, P value < 0.0001 (mean 41.46 in bisphosphonate group and 6.06 in control group) was noted in bisphosphonate group.","[{'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Department of Orthopaedics, AIIMS, New Delhi, India.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Orthopaedics, Hamdard Institute of Medical Sciences and Research, India.'}, {'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Sampath', 'Affiliation': 'Department of Orthopaedics, AIIMS, New Delhi, India.'}, {'ForeName': 'Shah Alam', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Department of Orthopaedics, AIIMS, New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics, Hamdard Institute of Medical Sciences and Research, India.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.09.011']
631,31750922,Resources in vulnerable young adults: self-assessments during preventive consultation with their general practitioner in Denmark.,"Inequality in health is increasing. People with many problems often lack energy to improve well-being and reduce their problems. This study analyses how psycho-socially challenged younger (20- to 44-year-old) patients described their own resources to reach lifestyle goals or alter life circumstances. Within the context of a randomized controlled trial, Danish participants had two structured preventive person-centred consultations with their general practitioner. Consultations focused on well-being, salutogenesis, resources, barriers and support of autonomy. Using the qualitative method: Systematic Text Condensation, we made thematic cross-analysis of patients' goal-specific resource statements described at the first consultation. Of the 209 patients, 191 (91%) chose one or two goals for a better life next year; nearly all (179) could recall and describe which resources they would use to reach their goal. We categorized resource statements into (i) personal constitution as 'willpower' and 'tenacity'; (ii) network, e.g. family; (iii) personal experience with identical or similar problems. Some patients needed to free up resources by handling psychological problems before being able to focus on lifestyle goals. The study demonstrates that patients with particular psycho-social problems could describe essential resources in a structured, salutogenic, preventive consultation with their general practitioner. Reflecting intrinsic and extrinsic motivation, these resources reflected dimensions of essential health theories like sense of coherence, self-efficacy and self-determination theory. Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes. This may be an important step to reducing inequality in health.",2020,"Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes.","['patients with particular psycho-social problems', 'psycho-socially challenged younger (20- to 44-year-old) patients', 'Danish participants had two structured preventive person-centred consultations with their general practitioner', 'vulnerable young adults']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037431', 'cui_str': 'Social Problems'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],209.0,0.0259725,"Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes.","[{'ForeName': 'Kirsten Schierup', 'Initials': 'KS', 'LastName': 'Freund', 'Affiliation': 'Center for General Practice, Aalborg University, Fyrkildevej 7, DK-9200 Aalborg Ø, Denmark.'}, {'ForeName': 'Ann Dorrit', 'Initials': 'AD', 'LastName': 'Guassora', 'Affiliation': 'The Research Unit and Section of General Practice, Department of Public Health, University of Copenhagen, Ø. Farimagsgade 5,opg.Q, DK-1014 Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Hegelund', 'Affiliation': 'Hovedgaden 43, DK-2970 Hoersholm, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Hvas', 'Affiliation': 'The Research Unit and Section of General Practice, Department of Public Health, University of Copenhagen, Ø. Farimagsgade 5,opg.Q, DK-1014 Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Lous', 'Affiliation': 'Research Unit of General Practice, Southern University, J. B. Winsløvs Vej 9A, DK-5000 Odense, Denmark.'}]",Health promotion international,['10.1093/heapro/daz114']
632,31133474,Physical Exercise Improves Function in Acutely Hospitalized Older Patients: Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVES


To evaluate the effects of an exercise intervention on physical function, maximal muscle strength, and muscle power in very old hospitalized patients.
DESIGN


In a randomized controlled trial, 130 hospitalized patients were allocated to an exercise intervention (n = 65) or a control group (n = 65). The intervention consisted of a multicomponent exercise training program performed during 5-7 consecutive days (2 sessions/d). The usual care group received habitual hospital care, which included physical rehabilitation when needed.
SETTING AND PARTICIPANTS


Acute care for elderly unit. Older adults age >75 years.
MEASURES


Physical function, assessed with the Short Physical Performance Battery test and the Gait Velocity Test (GVT), were the primary endpoints. The GVT was also administered under dual-task conditions (ie, verbal and arithmetic GVT). The functional tasks were recorded using an inertial sensor unit to determine the movement pattern. The secondary endpoints were maximal muscle strength and muscle power output.
RESULTS


The exercise intervention program provided significant benefits over usual care. At discharge (primary time point), the exercise group showed a mean increase of 1.7 points in the Short Physical Performance Battery scale (95% confidence interval [CI] 0.98, 2.42) and 0.14 m·s-1 in the GVT (95% CI 0.086, 0.194) over the usual care group. The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035). Significant benefits were also observed in the intervention group in movement pattern, as well as in muscle strength and muscle power.
CONCLUSIONS AND IMPLICATIONS


An individualized multicomponent exercise training program improves physical function, maximal muscle strength, and muscle power in acutely hospitalized older patients. These findings support the importance of physical exercise for avoiding the loss of physical functional capacity that frequently occurs during hospitalization in older adults.",2019,"The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035).","['very old hospitalized patients', 'Older adults age >75\xa0years', 'acutely hospitalized older patients', 'Acute care for elderly unit', '130 hospitalized patients', 'older adults', 'Acutely Hospitalized Older Patients']","['habitual hospital care, which included physical rehabilitation when needed', 'Physical Exercise', 'individualized multicomponent exercise training program', 'multicomponent exercise training program', 'exercise intervention', 'physical exercise', 'exercise intervention program']","['Short Physical Performance Battery test and the Gait Velocity Test (GVT', 'arithmetic GVT', 'Short Physical Performance Battery scale', 'physical function, maximal muscle strength, and muscle power', 'maximal muscle strength and muscle power output', 'muscle strength and muscle power']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]",130.0,0.0569571,"The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035).","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Geriatric Department, Complejo Hospitalario de Navarra (CHN), Pamplona, Navarra, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Casas-Herrero', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Geriatric Department, Complejo Hospitalario de Navarra (CHN), Pamplona, Navarra, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucía', 'Affiliation': ""CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain; Research Institute of the Hospital 12 de Octubre ('i+12'), Madrid, Spain.""}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mikel.izquierdo@gmail.com.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.04.001']
633,31594037,Exposure-Response Analyses for Upadacitinib Efficacy and Safety in the Crohn's Disease CELEST Study and Bridging to the Extended-Release Formulation.,"Upadacitinib plasma concentrations, efficacy, and safety data from 216 subjects with moderate-to-severe active Crohn's disease (CD) from the 16-week induction period of the CELEST study were analyzed to characterize upadacitinib exposure-response relationships in CD. Subjects in CELEST received either placebo or upadacitinib (3, 6, 12, 24 mg b.i.d. or 24 mg q.d.). Exposure-response models were developed and utilized to simulate efficacy of induction doses of the immediate-release (IR) and extended-release (ER) formulations. Upadacitinib exposures associated with 18-24 mg b.i.d. (IR formulation) or 45-60 mg q.d. (ER formulation) are estimated to have greater efficacy during 12-week induction in patients with CD compared with lower doses. No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study. These analyses informed the selection of upadacitinib induction dose for phase III studies in CD.",2020,"No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at Week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study.","[""216 subjects with moderately-to-severely active Crohn's disease (CD""]",['placebo or upadacitinib'],"['Upadacitinib plasma concentrations, efficacy, and safety data', 'hemoglobin or lymphocytes']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}]",216.0,0.019054,"No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at Week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study.","[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Klünder', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Lacerda', 'Affiliation': 'Immunology Development, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1668']
634,31730401,Can Reliability of the Chinese Medicine Diagnostic Process Be Improved? Results of a Prospective Randomized Controlled Trial.,"Background:  The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration.  Objectives:  (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability.  Design:  Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training.  Analysis:  The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings.  Results:  Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant ( p  = 0.227 and  p  = 0.126, respectively).  Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.",2019,Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument.,['women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM'],"['Traditional Chinese Medicine (TCM', 'TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training']",['reliability of TCM diagnosis of dysmenorrhea'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025129', 'cui_str': 'Traditional Medicine, East Asia'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",38.0,0.0421075,Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument.,"[{'ForeName': 'Rosa N', 'Initials': 'RN', 'LastName': 'Schnyer', 'Affiliation': 'Adult Health, University of Texas School of Nursing, Austin, TX.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McKnight', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, VA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, MCPH University, Worcester, MA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobson', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Ledegza', 'Affiliation': 'Alkermes, Inc., Waltham, MA.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Quilty', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.""}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0260']
635,28641369,Markers of Inflammation and Incident Breast Cancer Risk in the Women's Health Study.,"Chronic inflammation may be a risk factor for the development and progression of breast cancer, yet it is unknown which inflammatory biomarkers and pathways are especially relevant. The present study included 27,071 participants (mean age = 54.5 years) in the Women's Health Study who were free of cancer and cardiovascular disease at enrollment (1992-1995), with baseline measures of 4 inflammatory biomarkers: high-sensitivity C-reactive protein, fibrinogen, N-acetyl side-chains of acute phase proteins, and soluble intercellular adhesion molecule-1. We used Cox proportional hazards regression models to evaluate associations between baseline concentrations of biomarkers and incident breast cancer, and adjusted for baseline and time-varying factors such as age and body mass index. Self-reported invasive breast cancer was confirmed against medical records for 1,497 incident cases (90% postmenopausal). We observed different patterns of risk depending on the inflammatory biomarker. There was a significant direct association between fibrinogen and breast cancer risk (for quintile 5 vs. quintile 1, adjusted hazard ratio = 1.25, 95% confidence interval: 1.03, 1.51; P for trend = 0.01). In contrast, soluble intercellular adhesion molecule-1 was inversely associated with breast cancer (for quintile 5 vs. quintile 1, adjusted hazard ratio = 0.79, 95% confidence interval: 0.66, 0.94; P for trend = 0.02). N-acetyl side-chains of acute phase proteins and high-sensitivity C-reactive protein were not associated with breast cancer. The complex association of chronic inflammation and breast cancer may be considered when formulating anti-inflammatory cancer prevention or intervention strategies.",2018,N-acetyl side-chains of acute phase proteins and high-sensitivity C-reactive protein were not associated with breast cancer.,"['1,497 incident cases (90% postmenopausal', ""27,071 participants (mean age = 54.5 years) in the Women's Health Study who were free of cancer and cardiovascular disease at enrollment (1992-1995), with baseline measures of 4 inflammatory biomarkers: high-sensitivity C-reactive protein, fibrinogen, N-acetyl side-chains of acute phase proteins, and soluble intercellular adhesion molecule-1""]",[],"['fibrinogen and breast cancer risk', 'soluble intercellular adhesion molecule-1']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0001347', 'cui_str': 'Reactants, Acute-Phase'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}]",[],"[{'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}]",27071.0,0.0246771,N-acetyl side-chains of acute phase proteins and high-sensitivity C-reactive protein were not associated with breast cancer.,"[{'ForeName': 'Deirdre K', 'Initials': 'DK', 'LastName': 'Tobias', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Akinkuolie', 'Affiliation': ""Center for Lipid Metabolomics, Divisions of Preventive Medicine and Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Paulette D', 'Initials': 'PD', 'LastName': 'Chandler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': ""Center for Lipid Metabolomics, Divisions of Preventive Medicine and Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Lipid Metabolomics, Divisions of Preventive Medicine and Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics, Divisions of Preventive Medicine and Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",American journal of epidemiology,['10.1093/aje/kwx250']
636,31678947,Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet.,"INTRODUCTION


The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.
METHODS AND ANALYSIS


This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.
ETHICS AND DISSEMINATION


The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


2015-005585-32.",2019,We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight.,"['individuals with obesity', '200 women and men (age 18-65 years) with obesity (body mass index 32-43\u2009kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8\u2009weeks in order to lose at least 5% of body weight']","['GLP-1 receptor agonist liraglutide and exercise', 'placebo', 'glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise', 'placebo, (2) exercise 150\u2009min/week+placebo, (3) liraglutide 3.0\u2009mg/day and (4) exercise 150\u2009min/week+liraglutide 3.0\u2009mg/day']","['weight loss and health', 'success rate of weight loss maintenance', 'change in body weight from randomisation to end-of-treatment']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",200.0,0.155604,We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight.,"[{'ForeName': 'Simon Birk Kjær', 'Initials': 'SBK', 'LastName': 'Jensen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Rehné', 'Initials': 'JR', 'LastName': 'Lundgren', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Janus', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian Rimer', 'Initials': 'CR', 'LastName': 'Juhl', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lisa Møller', 'Initials': 'LM', 'LastName': 'Olsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente Merete', 'Initials': 'BM', 'LastName': 'Stallknecht', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Signe Sørensen', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark torekov@sund.ku.dk.'}]",BMJ open,['10.1136/bmjopen-2019-031431']
637,31112605,Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention.,"BACKGROUND AND OBJECTIVES


Social isolation is associated with a higher risk of dementia. We previously conducted and showed the efficacy of an intervention which uses conversation (the core component of social interactions) as a tool to enhance cognitive function. We now explore whether cognitive improvements through conversation-based intervention depend on an individual's personality.
RESEARCH DESIGN AND METHODS


We reexamined data from a 6-week randomized controlled trial (ClinicalTrials.gov Number: NCT01571427) to determine whether conversation-based intervention effects were moderated by personality traits in 83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment). The intervention group participated in daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks. At baseline, psychosocial questionnaires and a neuropsychological battery were completed.
RESULTS


Intervention group participants with high agreeableness, conscientiousness, and extraversion exhibited significant improvements in language-based executive function tasks beyond changes in the control group (ps < .05). An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
DISCUSSION AND IMPLICATIONS


Our exploratory findings suggest the adaptive role of personality traits in conversation-based cognitive interventions may be limited to tasks incorporating a language component, and offer initial evidence for personalized approaches to cognitive health in late life.",2020,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","['83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment']",['daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks'],"['language-based executive function tasks', 'Cognitive Function', 'delayed recall memory and working memory tasks']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",83.0,0.0918085,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Cerino', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hooker', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Goodrich', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}, {'ForeName': 'Hiroko H', 'Initials': 'HH', 'LastName': 'Dodge', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}]",The Gerontologist,['10.1093/geront/gnz063']
638,31614215,"A pragmatic, adaptive clinical trial design for a rare disease: The FOcal Cerebral Arteriopathy Steroid (FOCAS) trial.","BACKGROUND


Pediatric stroke investigators identified as their top research priority a clinical trial of corticosteroids for focal cerebral arteriopathy (FCA). However, FCA is both rare and an acute condition making it infeasible to enroll the large sample sizes needed for standard, confirmatory clinical trials. We present a pragmatic approach to clinical trial design that may inform the approach to other rare disorders.
METHODS


We surveyed pediatric stroke experts to determine the level of evidence that would impact their clinical management of FCA. Incorporating survey results, a randomized, group sequential Bayesian adaptive design was proposed based on a quantitative radiologic outcome measure (change from baseline in change in the FCA Severity Score). Using accumulating information, the design determines whether intervention is better than control with high probability.
RESULTS


Among 21 (100%) respondents, the probability of corticosteroid efficacy that would lead the experts to treat was 30% (median). The probability of efficacy that would make them unwilling to randomize (because they would feel all children should receive corticosteroids) was 70%. Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
CONCLUSIONS


Designs in rare diseases require special considerations; this is especially true for this childhood disease, which is both uncommon and acute. This design has incorporated expert consensus to establish the criteria for success, formal monitoring rules for safety, and early stopping rules.",2019,"Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
",['42 subjects controls'],['FCA'],['probability of corticosteroid efficacy'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",42.0,0.171489,"Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
","[{'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Fullerton', 'Affiliation': 'Departments of Neurology & Pediatrics, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States. Electronic address: elmj@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105852']
639,31095318,Engaging Caregivers in Health-Related Housing Decisions for Older Adults With Cognitive Impairment: A Cluster Randomized Trial.,"BACKGROUND AND OBJECTIVES


Informal caregivers are rarely as involved as they want to be in the housing decisions of cognitively impaired older adults. Lack of awareness of available options and their benefits and risks may lead to decisions that do not reflect older adults' preferences, and to guilt and regret. We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
RESEARCH DESIGN AND METHODS


In a two-arm pragmatic cluster randomized trial with home care teams working in health centers in the Province of Quebec, we randomized health centers to receive training in interprofessional SDM (intervention) or not (control). Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team. The primary outcome was the proportion of caregivers reporting an active role in decision making. We performed intention-to-treat multilevel analysis.
RESULTS


We consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis. In the intervention arm, the proportion of caregivers reporting an active role in decision making increased by 12% (95% CI -2% to 27%; p = .10). After removal of an influential cluster outlier, the proportion increased to 18% (95% CI: 7%-29%; p < .01).
DISCUSSION AND IMPLICATIONS


Training home care teams in interprofessional SDM increased caregiver involvement in health-related housing decisions for cognitively impaired older adults.",2020,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","['in health centers in the Province of Quebec', 'cognitively impaired older adults', 'consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis', 'Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team', 'Older Adults With Cognitive Impairment']","['home care teams working', 'training in interprofessional SDM (intervention) or not (control']",['proportion of caregivers reporting an active role in decision making'],"[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.262906,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","[{'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute and Faculty of Health Sciences, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Brière', 'Affiliation': 'Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Québec, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Freitas', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'Garvelink', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Maman Joyce', 'Initials': 'MJ', 'LastName': 'Dogba', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Pierre J', 'Initials': 'PJ', 'LastName': 'Durand', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'School of Nutrition, Québec, Canada.'}, {'ForeName': 'Jordie', 'Initials': 'J', 'LastName': 'Croteau', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Louis-Paul', 'Initials': 'LP', 'LastName': 'Rivest', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, Québec, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}]",The Gerontologist,['10.1093/geront/gnz045']
640,31033008,Effects of Preoperative Extracorporeal Shockwave Therapy on Scar Formation-A Pilot Study on 24 Subjects Undergoing Abdominoplasty Surgery.,"OBJECTIVES


Extracorporeal shockwave therapy (ESWT) has been demonstrated as a feasible noninvasive method to improve wound healing. This effect was demonstrated to result from increased perfusion and angiogenesis due to systemic growth factor expression. We, therefore, hypothesized that preoperative ESWT reduces scar formation after surgery.
METHODS


A prospective, controlled pilot study on 24 patients undergoing abdominoplasty was conducted and the efficacy of preoperative unfocused, low energy EWST was evaluated. The right and left half of the operative area were randomly allocated to ESWT or placebo treatment in intrapatient control design. At 6 and 12 weeks after surgery, scar formation was evaluated by 19 different scar parameters included in the patient, observer scar assessment, and the Vancouver scar scale.
RESULTS


The overall rating of the Vancouver and POSAS scale with Mann-Whitney (MW) analysis revealed a clear trend favoring ESWT. At week 6, 7 of 19 parameters clearly favored ESWT (MW > 0.53). At week 12, 8 of 19 parameters clearly favored ESWT. The largest differences were observed in thickness and overall impression (Vancouver scar scale).
CONCLUSIONS


ESWT presumably reduces scar formation and postoperative symptoms after abdominoplasty surgery. Further studies are required to confirm ESWT efficacy with statistical significance. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,The overall rating of the Vancouver and POSAS scale with Mann-Whitney (MW) analysis revealed a clear trend favoring ESWT.,"['24 patients undergoing abdominoplasty', '24 Subjects Undergoing Abdominoplasty Surgery', '2019']","['ESWT or placebo', 'Preoperative Extracorporeal Shockwave Therapy', 'Extracorporeal shockwave therapy (ESWT']","['overall rating of the Vancouver and POSAS scale', 'scar formation', 'thickness and overall impression (Vancouver scar scale', 'scar formation and postoperative symptoms', 'Vancouver scar scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.024812,The overall rating of the Vancouver and POSAS scale with Mann-Whitney (MW) analysis revealed a clear trend favoring ESWT.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Russe', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Wechselberger', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schwaiger', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hladik', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Traintinger', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital of the Barmherzige Brüder, Paracelsus Medical University Salzburg, Kajetanerplatz 1, 5020, Salzburg, Austria.'}]",Lasers in surgery and medicine,['10.1002/lsm.23089']
641,31553254,Dose- and starting time-dependent effect of the application of EGF to the regeneration of traumatic eardrum.,"Background:  Some studies have shown that topical application of epidermal growth factor (EGF) accelerates healing in traumatic tympanic membrane perforations (TMPs), however, the optimal dose and starting time of application have not been established. Objectives:  To determine the optimal dose and starting time of application of EGF for the regeneration of TMPs. Methods and materials:  Patients with traumatic TMPs were first randomly assigned to low-dose EGF, high-dose EGF, and spontaneous healing groups. Then, the same patients were retrospectively analyzed at 6 months based on the starting time of treatment. The closure times, closure rates, and hearing gain were compared among the groups at 6 months. Results:  The mean closure time was 10.20 ± 5.13 days in the low-dosage EGF group, 14.39 ± 6.20 days in the high-dosage EGF group, and 33.17 ± 16.37 days in the spontaneous healing group; the difference was significant ( p  < .001). Conclusions:  Daily application of EGF shortened the closure time of traumatic TMPs compared with those that healed spontaneously. However, high-dose EGF instead prolonged the closure time compared to low-dose EGF.",2019,"The closure times, closure rates, and hearing gain were compared among the groups at 6 months.  ",['Patients with traumatic TMPs'],"['EGF', 'epidermal growth factor (EGF']","['closure time', 'closure time of traumatic TMPs', 'mean closure time', 'closure times, closure rates, and hearing gain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}]","[{'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]",,0.029979,"The closure times, closure rates, and hearing gain were compared among the groups at 6 months.  ","[{'ForeName': 'Zheng Cai', 'Initials': 'ZC', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu Central Hospital, Zhejiang, China.'}]",Acta oto-laryngologica,['10.1080/00016489.2019.1667533']
642,31097514,Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.,"There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance.Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 µg  versus  placebo add-on therapy in patients with symptomatic asthma aged 1-17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment.Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 µg (51%), tiotropium 2.5 µg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 µg) than with placebo, particularly during the seasonal peaks of these AEs.This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.",2019,"Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex.","['paediatric\xa0asthma patients', 'paediatric patients with not fully controlled asthma', 'paediatric patients with symptomatic asthma', '1691 patients treated, 1119 received', 'patients with symptomatic asthma aged 1-17\u2005years']","['Tiotropium', 'tiotropium', 'tiotropium 5 or 2.5\u2005µg  versus  placebo', 'placebo']","['number of AEs related to asthma symptoms and exacerbations', 'adverse events (AEs) and serious AEs (SAEs']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1691.0,0.359001,"Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'Dept of Pediatric Pulmonology and Allergy, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany christian.vogelberg@uniklinikum-dresden.de.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital of Colorado and the University of Colorado Denver School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Elianne J L E', 'Initials': 'EJLE', 'LastName': 'Vrijlandt', 'Affiliation': ""Dept of Pediatric Pulmonology and Pediatric Allergy, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Attilio L', 'Initials': 'AL', 'LastName': 'Boner', 'Affiliation': 'UOC di Pediatria, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno Infantili, Policlinico ""G. Rossi"", Verona, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'El Azzi', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Sebastian Dan', 'Initials': 'SD', 'LastName': 'Vulcu', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Eickmeier', 'Affiliation': ""Dept of Pediatric Allergology, Pulmonology and Cystic Fibrosis, University Children's Hospital, Goethe University, Frankfurt, Germany.""}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel, Bielefeld and Allergy Center of the Ruhr University, Bochum, Germany.'}]",The European respiratory journal,['10.1183/13993003.01824-2018']
643,31606398,Moderators of Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Chronic Pain: Who Benefits From Treatment at Long-Term Follow-Up?,"Cognitive behavioral therapy (CBT) is effective for pediatric chronic pain, but little is understood about which youth are most likely to benefit. The current study aimed to identify individual characteristics for which CBT yielded the greatest (and least) clinical benefit among adolescents with chronic pain participating in a multicenter randomized controlled trial of Internet-delivered CBT (WebMAP2). A total of 273 adolescents ages 11 to 17 with chronic pain (M age = 14.7; 75.1% female) were randomly assigned to Internet-delivered CBT or Internet-delivered pain education and evaluated at pretreatment, post-treatment, and 2 longer term follow-up periods (6 and 12 months). Multilevel growth models tested several adolescent- and parent-level moderators of change in pain-related disability including 1) adolescent age, sex, pain characteristics, distress, and sleep quality and 2) parent education level, distress, and protective parenting behavior. Younger adolescents (ages 11-14; vs older adolescents ages 15-17) and those whose parents experienced lower levels (vs higher levels) of emotional distress responded better to Internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment. This study expands knowledge on who benefits most from Internet-delivered psychological treatment for youth with chronic pain in the context of a large multicenter randomized controlled trial, suggesting several avenues for maximizing treatment efficacy and durability in this population. PERSPECTIVE: This study identified adolescent- and parent-level predictors of treatment response to Internet-based CBT for pediatric chronic pain up to 12 months later. Younger adolescents and those whose parents had lower levels of distress may particularly benefit from this intervention. Older adolescents and those whose parents exhibit higher distress may require alternative treatment approaches.",2020,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","['Young adolescents (ages 11-14 vs. older adolescents ages 15-17', 'Older adolescents', 'adolescents with chronic pain participating in a multi-center randomized controlled trial (RCT) of', '273 adolescents ages 11-17 with chronic pain (Mage=14.7; 75.1% female', 'adolescents with chronic pain', 'Younger adolescents', 'youth with chronic pain']","['internet-delivered cognitive-behavioral therapy', 'Internet-based CBT', 'internet-delivered CBT (WebMAP2', 'Cognitive-behavioral therapy (CBT', 'internet-delivered CBT or internet-delivered pain education and evaluated at pre-treatment, post-treatment']","['pain-related disability including (1) adolescent age, sex, pain characteristics, distress, and sleep quality and (2) parent education level, distress, and protective parenting behaviors', 'disability', 'emotional distress']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",273.0,0.0873187,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","[{'ForeName': 'Caitlin B', 'Initials': 'CB', 'LastName': 'Murray', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington. Electronic address: caitlin.murray@seattlechildrens.org.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Loren', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; Loyola University Chicago, Chicago, Illinois.""}, {'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; University of Washington, Seattle, Washington.""}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.001']
644,31735251,Repeated Exposure to Perceptual Illusion Challenges Reduces Anxiety Sensitivity Cognitive Concerns: Evidence From a Randomized Clinical Trial.,"BACKGROUND


Anxiety sensitivity cognitive concerns (ASCC), or fear of cognitive dyscontrol sensations, confers risk for anxiety and mood psychopathology. Recent work demonstrated that novel perceptual challenges generated by a head mounted display can elicit fear among those with elevated ASCC. This suggests that interoceptive exposure to perceptual challenges may offer a means to mitigate ASCC. This study was designed to evaluate whether repeated exposure to novel perceptual challenges can reduce ASCC, and if these effects are stronger among those experiencing greater negative emotionality as a proxy for individuals likely to present for treatment.
METHODS


Participants with elevated ASCC (N = 57) were randomized to one of three experimental conditions utilizing a head-mounted display. In the rotations condition (n = 20), participants viewed themselves spinning in a circle. In the opposite directions condition (n = 20), participants turned their head while the camera moved in the opposite direction creating dissonance in their visual field. In the control condition (n = 17), participants completed a series of simple arithmetic problems.
RESULTS


Participants in the rotation condition, relative to control, reported significant reductions in ASCC from pre- to post-exposure and these effects were strongest for those with elevated negative affect. The main effect of the opposite directions exposure on post-treatment ASCC was non-significant, but follow-up analyses revealed that reductions in ASCC were observed among those with elevated negative affectivity.
DISCUSSION


Perceptual illusion challenges appear to have utility for reducing ASCC through repeated exposure. There was evidence for the perceptual illusion exercises, particularly the rotations condition, specifically reducing ASCC, making this challenge the first we are aware of that specifically targets ASCC-related concerns.
LIMITATIONS


As a proof-of-concept study, the present sample was not recruited for clinically-significant psychopathology, and only a brief follow-up was utilized. Future research should utilize a longer follow-up and test if these exposures mitigate ASCC-relevant psychopathology among clinical samples.",2019,"RESULTS


Participants in the rotation condition, relative to control, reported significant reductions in ASCC from pre- to post-exposure and these effects were strongest for those with elevated negative affect.",['Participants with elevated ASCC (N = 57'],['Repeated Exposure to Perceptual Illusion Challenges'],['ASCC'],[],"[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}]",[],,0.0461486,"RESULTS


Participants in the rotation condition, relative to control, reported significant reductions in ASCC from pre- to post-exposure and these effects were strongest for those with elevated negative affect.","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Albanese', 'Affiliation': 'Florida State University. Electronic address: albanese@psy.fsu.edu.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bauer', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Alexa M', 'Initials': 'AM', 'LastName': 'Raudales', 'Affiliation': 'Florida State University.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Capron', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University.'}]",Behavior therapy,['10.1016/j.beth.2019.04.003']
645,31087313,Role of Oropharyngeal Administration of Colostrum in Very Low Birth Weight Infants for Reducing Necrotizing Enterocolitis: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to study the role of oropharyngeal administration of colostrum (OAC) in very-low-birth-weight infants for reducing necrotizing enterocolitis (NEC).
STUDY DESIGN


In this randomized controlled trial, 117 infants were enrolled, 59 were randomized to OAC group and 58 to routine care group. Infants with birth weight ≤ 1,250 g and/or gestational age ≤ 30 weeks were enrolled. Infants in OAC group received maternal colostrum (0.2 mL), 0.1 mL on either side, after 24 hours of postnatal life and were given every 2 hour for the next 72 hours irrespective of the enteral feeding status of the neonate. The primary outcome of the study was the incidence of NEC (stage 2 or 3).
RESULTS


Baseline characteristics were comparable between the two groups. There was no significant reduction in the incidence of NEC in OAC group (0 [0%] vs. 3 [7.1%];  p  = 0.11). There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
CONCLUSION


OAC is safe and reduces the duration of hospital stay.",2020,"There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
","['very-low-birth-weight infants for reducing necrotizing enterocolitis (NEC', 'and/or gestational age\u2009≤\u200930 weeks were enrolled', '117 infants were enrolled, 59 were randomized to OAC group and 58 to routine care group', 'Infants with birth weight\u2009≤\u20091,250\u2009g']","['oropharyngeal administration of colostrum (OAC', 'maternal colostrum', 'Oropharyngeal Administration of Colostrum']","['hospital stay', 'incidence of NEC (stage 2 or 3', 'early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia', 'duration of hospital stay', 'Necrotizing Enterocolitis', 'incidence of NEC']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}]",117.0,0.190344,"There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Neonatology, National Institute of Medical Science, Jaipur, Rajasthan, India.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Department of Pediatrics, National Institute of Medical Science, Jaipur, Rajasthan, India.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Farahbakhsh', 'Affiliation': ""Department of Pediatric Pulmonology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Helping Hand Polyclinic, Jaipur, Rajasthan, India.'}]",American journal of perinatology,['10.1055/s-0039-1688817']
646,31078486,Effects of the FIT-HIP Intervention for Fear of Falling After Hip Fracture: A Cluster-Randomized Controlled Trial in Geriatric Rehabilitation.,"OBJECTIVES


Fear of falling (FoF) is common after hip fracture and can impede functional recovery because of activity restriction. The Fear of falling InTervention in HIP fracture geriatric rehabilitation (FIT-HIP intervention) was designed to target FoF and consequently to improve mobility. The aim of this study was to evaluate the effect of the FIT-HIP intervention in patients with FoF in geriatric rehabilitation (GR) after hip fracture.
DESIGN, SETTING, AND PARTICIPANTS


This cluster-randomized controlled trial was performed in 11 post-acute GR units in the Netherlands (2016-2017). Six clusters were assigned to the intervention group, 5 to the usual care group. We included 78 patients with hip fracture and FoF (aged ≥65 years; 39 per group).
INTERVENTION(S)


The FIT-HIP intervention is a multicomponent cognitive behavioral intervention conducted by physiotherapists, embedded in usual care in GR. The FIT-HIP intervention was compared to usual care in GR.
MEASUREMENTS


FoF was assessed with the Falls Efficacy Scale-International (FES-I) and mobility, with the Performance Oriented Mobility Assessment (POMA). Data were collected at baseline, discharge, and 3 and 6 months postdischarge from GR. Primary endpoints were change scores at discharge. Linear mixed models were used to evaluate the treatment effect.
RESULTS


No significant between-group differences were observed for primary outcome measures. With the usual care group as reference, the FES-I estimated difference between mean change scores was 3.3 [95% confidence interval (CI) -1.0, 7.5, P = .13] at discharge from GR; -4.1 (95% CI -11.8, 3.6, P = .29) after 3 months; and -2.8 (95% CI -10.0, 4.4, P = .44) after 6 months. POMA estimated difference was -0.3 (95% CI -6.5, 5.8, P = .90).
CONCLUSION/IMPLICATIONS


The FIT-HIP intervention was not effective in reducing FoF. Possibly FoF (shortly) after hip fracture can to some extent be appropriate. This may imply the study was not able to accurately identify and accordingly treat FoF that is maladaptive (reflective of disproportionate anxiety).",2019,No significant between-group differences were observed for primary outcome measures.,"['After Hip Fracture', '11 post-acute GR units in the Netherlands (2016-2017', 'patients with FoF in geriatric rehabilitation (GR) after hip fracture', '78 patients with hip fracture and FoF (aged ≥65\xa0years; 39 per group']","['FIT-HIP Intervention', 'FIT-HIP intervention']","['Fear of Falling', 'change scores at discharge', 'Falls Efficacy Scale-International (FES-I) and mobility, with the Performance Oriented Mobility Assessment (POMA']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}]",78.0,0.0829924,No significant between-group differences were observed for primary outcome measures.,"[{'ForeName': 'Maaike N', 'Initials': 'MN', 'LastName': 'Scheffers-Barnhoorn', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: m.n.scheffers-barnhoorn@lumc.nl.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'van Eijk', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jolanda C M', 'Initials': 'JCM', 'LastName': 'van Haastregt', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; Department of Family Medicine and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Romke', 'Initials': 'R', 'LastName': 'van Balen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Gertrudis I J M', 'Initials': 'GIJM', 'LastName': 'Kempen', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.03.009']
647,29982544,High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial.,"Background


Combined omega-3 fatty acid and vitamin D supplementation may improve multiple sclerosis (MS) by correcting metabolic abnormalities and attenuating oxidative stress and inflammation.
Objective


This study aimed to determine the effects of ω-3 fatty acid and vitamin D cosupplementation on the disability score and metabolic status of patients with MS.
Methods


This was a randomized, placebo-controlled clinical trial with Expanded Disability Status Scale (EDSS) score and inflammation as primary outcomes and oxidative stress biomarkers and metabolic profile as secondary outcomes. Patients, aged 18-55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n = 53) and randomly received a combined 2 × 1000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo for 12 wk. The placebos were matched in colour, shape, size, packaging, smell, and taste with supplements. Fasting blood samples were collected at baseline and end of intervention to measure different outcomes. Multiple linear regression models were used to assess treatment effects on outcomes adjusting for confounding variables.
Results


Patients taking ω-3 fatty acid plus vitamin D supplements showed a significant improvement in EDSS (β -0.18; 95% CI: -0.33, -0.04; P = 0.01), compared with placebo. Serum high-sensitivity C-reactive protein (β -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (β -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group. In addition, ω-3 fatty acid and vitamin D cosupplementation resulted in a significant reduction in serum insulin, insulin resistance, and total/HDL-cholesterol, and a significant increase in insulin sensitivity and serum HDL-cholesterol concentrations.
Conclusion


Overall, taking ω-3 fatty acid and vitamin D supplements for 12 wk by patients with MS had beneficial effects on EDSS and metabolic status. This trial was registered at the Iranian website (www.irct.ir) for registration of clinical trials as IRCT2017090133941N20.",2018,"Serum high-sensitivity C-reactive protein (β -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (β -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group.","['Patients with Multiple Sclerosis', 'Patients, aged 18-55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n\xa0=\xa053', 'patients with MS']","['ω-3 fatty acid and vitamin D cosupplementation', 'placebo', 'combined 2\xa0×\xa01000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo', 'ω-3 fatty acid and vitamin D supplements', 'omega-3 fatty acid and vitamin D supplementation', 'High-dose ω-3 Fatty Acid Plus Vitamin D3']","['serum insulin, insulin resistance, and total/HDL-cholesterol', 'total glutathione', 'malondialdehyde concentrations', 'EDSS and metabolic status', 'insulin sensitivity and serum HDL-cholesterol concentrations', 'disability score and metabolic status', 'EDSS', 'Serum high-sensitivity C-reactive protein', 'Fasting blood samples', 'Disability Status Scale (EDSS) score and inflammation', 'plasma total antioxidant capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0222045'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.551138,"Serum high-sensitivity C-reactive protein (β -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (β -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group.","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Department of Neurology, School of Medicine.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afarini', 'Affiliation': 'Department of Neurology, School of Medicine.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Abolhassani', 'Affiliation': 'Department of Neurology, School of Medicine.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': ""Pure North S'Energy Foundation, Calgary, Alberta, Canada.""}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Masoud', 'Affiliation': 'Department of Neurology, School of Medicine.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}]",The Journal of nutrition,['10.1093/jn/nxy116']
648,31035808,Perceived cancer-related benefits of quitting smoking and associations with quit intentions among recently diagnosed cancer patients.,"One third of smokers diagnosed with cancer continue smoking, perhaps due to low perceived cancer-related benefits of cessation. To examine perceived cancer-related benefits of quitting among newly diagnosed cancer patients who smoke and associations with quit intentions, baseline measures from patients (N = 303) enrolled in a randomized controlled trial were analyzed using hierarchical regression models and bootstrapping. Higher perceived cancer-related benefits of quitting were associated with having a smoking-related cancer and less education. Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers. For smokers with smoking-related cancers, perceived cancer-related benefits of quitting are correlated with quit intentions.",2019,"Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers.","['newly diagnosed cancer patients who smoke and associations with quit intentions, baseline measures from patients (N\u2009=\u2009303', 'diagnosed cancer patients']",[],['Perceived cancer-related benefits of quitting and quit intentions'],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}]",[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",303.0,0.0755629,"Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Neil', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': '3 Memorial Sloan Kettering Cancer Center, USA.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Hawari', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': '1 Massachusetts General Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105319845131']
649,31708060,Stroke Warning Information and Faster Treatment (SWIFT): Cost-Effectiveness of a Stroke Preparedness Intervention.,"BACKGROUND


Less than 25% of stroke patients arrive to an emergency department within the 3-hour treatment window.
OBJECTIVE


We evaluated the cost-effectiveness of a stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT]), a stroke intervention demonstrating capacity to decrease race-ethnic disparities in ED arrival times.
METHODS


Using the literature and SWIFT outcomes for 2 interventions, enhanced educational (EE) materials, and interactive intervention (II), we assess the cost-effectiveness of SWIFT in 2 ways: (1) Markov model, and (2) cost-to-outcome ratio. The Markov model primary outcome was the cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY. The primary cost-to-outcome endpoint was cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity. We assessed the ICER of II and EE versus standard care (SC) from a health sector and societal perspective using 2015 USD, a time horizon of 5 years, and a discount rate of 3%.
RESULTS


The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity. Using a societal perspective, the ICER for EE versus SC was $84 643 per QALY gained and the ICER for II versus EE was $59 058 per QALY gained. Incorporating fixed costs, EE and II would need to administered to 507 and 1693 or more patients, respectively, to achieve an ICER of $100 000/QALY.
CONCLUSION


II was a cost-effective strategy compared with both EE and SC. Nevertheless, high initial fixed costs associated with II may limit its cost-effectiveness in settings with smaller patient populations.",2019,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.",[],"['stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT', 'Stroke Warning Information and Faster Treatment (SWIFT', 'Stroke Preparedness Intervention']","['Cost-Effectiveness', 'ICER of II and EE versus standard care (SC', 'cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity', 'cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY', 'cost-effectiveness']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1831581', 'cui_str': 'Subfamily Apodinae'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",,0.0544505,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stevens', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA; Department of Population Health, New York University School of Medicine, New York, NY, USA. Electronic address: elizabeth.stevens@nyumc.org.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Heather Carman', 'Initials': 'HC', 'LastName': 'Kuczynski', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Boden-Albala', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.06.003']
650,29641242,Matrix Analysis of Traditional Chinese Medicine Differential Diagnoses in Gulf War Illness.,"Objective:  To qualitatively categorize Traditional Chinese Medicine (TCM) differential diagnoses in a sample of veterans with Gulf War Illness (GWI) pre- and postacupuncture treatment.  Subjects and methods:  The authors randomized 104 veterans diagnosed with GWI to a 6-month acupuncture intervention that consisted of either weekly or biweekly individualized acupuncture treatments. TCM differential diagnoses were recorded at baseline and at 6 months. These TCM diagnoses were evaluated using Matrix Analysis to determine co-occurring patterns of excess, deficiency, and channel imbalances. These diagnoses were examined within and between participants to determine patterns of change and to assess stability of TCM diagnoses over time.  Results:  Frequencies of diagnoses of excess, deficiency, and channel patterns were tabulated. Diagnoses of excess combined with deficiency decreased from 43% at baseline to 39% of the sample at 6 months. Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration. The authors observed a trend over time of decreased numbers of individuals presenting with all three types of differential diagnosis combinations. This may suggest that fewer people were diagnosed with concurrent excess, deficiency, and channel imbalances and perhaps a lessening in the complexity of their presentation.  Conclusion:  This is the first published article that organizes and defines TCM differential diagnoses using Matrix Analysis; currently, there are no TCM frameworks for GWI. These findings are preliminary given the sample size and the amount of missing data at 6 months. Characterization of the TCM clinical presentation of veterans suffering from GWI may help us better understand the potential role that East Asian medicine may play in managing veterans with GWI and the design of effective acupuncture treatments based on TCM. The development of a TCM manual for treating GWI is merited.",2019,"Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration.","['veterans suffering from GWI', 'Traditional Chinese Medicine Differential Diagnoses in Gulf War Illness', '104 veterans diagnosed with GWI to a 6-month', 'veterans with Gulf War Illness (GWI) pre- and postacupuncture treatment']","['individualized acupuncture treatments', 'categorize Traditional Chinese Medicine (TCM', 'acupuncture intervention']","['stability of TCM diagnoses over time', 'deficiency+channel imbalances', 'Excess+deficiency+channel imbalances', 'TCM differential diagnoses']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0011906', 'cui_str': 'Differential Diagnosis'}, {'cui': 'C1449761', 'cui_str': 'Gulf War'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011906', 'cui_str': 'Differential Diagnosis'}]",104.0,0.0995503,"Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Taylor-Swanson', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Durham, NC.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Schnyer', 'Affiliation': 'School of Nursing, University of Texas, Austin, TX.'}, {'ForeName': 'Kai-Yin', 'Initials': 'KY', 'LastName': 'Hsu', 'Affiliation': 'New England School of Acupuncture, MCPHS, Boston, MA.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Schmitt', 'Affiliation': 'New England School of Acupuncture, MCPHS, Boston, MA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, MCPHS, Boston, MA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2017.0299']
651,31497988,Relationships between generalized impulsivity and subjective stimulant and sedative responses following alcohol administration.,"Impulsivity and subjective response (SR) to alcohol (i.e., individual differences in sensitivity to pharmacologic alcohol effects) are both empirically supported risk factors for alcohol use disorder; however, these constructs have been infrequently studied as related risk factors. The present investigation examined a self-report measure of impulsivity (i.e., the Barratt Impulsiveness Scale, Version 11) in relation to acute alcohol effects (i.e., stimulant and sedative SR). Participants came from 2 cohorts of the Chicago Social Drinking Project. Heavy and light drinkers from Cohort 1 (n = 156) and heavy social drinkers from Cohort 2 (n = 104) were examined using identical laboratory protocols following oral alcohol administration using a within-subject, double-blind, placebo-controlled laboratory study design. Self-reported impulsivity and, for comparison purposes, sensation seeking were measured at baseline, and SR was measured once prior to and 4 times following alcohol administration. More impulsive light, but not heavy, drinkers reported heightened stimulant SR following alcohol administration. High impulsive, light drinkers reported stimulant SR at a magnitude similar to that for heavy drinkers, whereas low impulsive, light drinkers reported limited stimulant SR. The interaction between impulsivity and sensation seeking did not statistically predict stimulant SR, and overall, impulsivity was a stronger predictor than was sensation seeking. However, impulsivity was not statistically predictive of dampened sedative SR among light or heavy drinkers. These findings partially replicate and extend the recent literature linking self-reported impulsivity to heightened stimulant SR from alcohol. Future directions include longitudinal studies and research relating multiple facets of impulsivity to SR. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"However, impulsivity was not statistically predictive of dampened sedative SR among light or heavy drinkers.","['Participants came from 2 cohorts of the Chicago Social Drinking Project', 'Heavy and light drinkers from Cohort 1 (n = 156) and heavy social drinkers from Cohort 2 (n = 104']",['placebo'],['Impulsivity and subjective response (SR'],"[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556299', 'cui_str': 'Light drinker (finding)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",2019.0,0.0176768,"However, impulsivity was not statistically predictive of dampened sedative SR among light or heavy drinkers.","[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Berey', 'Affiliation': 'Department of Health Education and Behavior, University of Florida.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Leeman', 'Affiliation': 'Department of Health Education and Behavior, University of Florida.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Chavarria', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000512']
652,30222505,An Intervention Tool to Increase Patient-Physician Discussion of Lifestyle Risk Factors for Breast Cancer.,"Background:  Risk assessment and discussion of lifestyle in primary care are crucial elements of breast cancer prevention and risk reduction. Our objective was to evaluate the impact of a breast cancer risk assessment and education tool on patient-physician discussion of behaviors and breast cancer risk.  Materials and Methods:  We conducted a randomized controlled trial with an ethnically and linguistically diverse sample of women, ages 40-74, from two primary care practices. Intervention participants completed a tablet computer-based Breast Cancer Risk Assessment and Education (BreastCARE) intervention in the waiting room before a scheduled visit. Both patients and physicians received an individualized risk report to discuss during the visit. Control patients underwent usual care. Telephone surveys assessed patient-physician discussion of weight, exercise, and alcohol use 1 week following the visit.  Results:  Among the 1235 participants, 27.7% (161/580) intervention and 22.3% (146/655) usual-care patients were high risk for breast cancer. Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96). There was no effect of the intervention on discussion of alcohol. Women with some college education were more likely to discuss their weight than those with high school education or less (OR = 1.75, 1.03-2.96). Similarly, non-English speakers were more likely to discuss their weight compared with English speakers (OR = 2.33, 1.04-5.22).  Conclusions:  BreastCARE is a feasible risk assessment tool that can successfully promote discussions about modifiable breast cancer risk factors between patients and primary care physicians.",2019,"Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96).","['Women with some college education', '1235 participants, 27.7% (161/580) intervention and 22.3% (146/655) usual-care patients were high risk for breast cancer', 'Breast Cancer', 'ethnically and linguistically diverse sample of women, ages 40-74, from two primary care practices']","['usual care', 'tablet computer-based Breast Cancer Risk Assessment and Education (BreastCARE) intervention']","['discussion of alcohol', 'discussions of regular exercise']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]",1235.0,0.0158711,"Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96).","[{'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Ozanne', 'Affiliation': 'Division of Health System Innovation and Research, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Karliner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Tice', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Livaudais-Toman', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Pasick', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Celia P', 'Initials': 'CP', 'LastName': 'Kaplan', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7026']
653,31732062,"Yacon syrup reduces postprandial glycemic response to breakfast: A randomized, crossover, double-blind clinical trial.","Yacon is a root rich in fructooligosaccharides (FOS), which act as prebiotics. Numerous studies have shown promising results in the technological aspects of producing yacon syrup. However, uncertainties exist concerning whether yacon syrup can modulate postprandial glucose and lipid profiles. In order to assess the effect of yacon syrup on postprandial glucose, insulin and triglyceride (TG) responses, a randomized, crossover, double-blind clinical intervention with 40 women (20 normal weight and 20 grade I obese) was performed. Participants underwent two-arms of intervention with at least a one-week wash-out period between visits. On each intervention day, after 12 h of fasting, an aliquot of blood was collected. For intervention A, volunteers consumed breakfast +40 g of placebo, whereas for intervention B, participants consumed breakfast +40 g of yacon syrup (14 g of FOS). Blood samples were drawn at 15, 30, 45, 60, 90, and 120 min. Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin. In conclusion, yacon syrup has a postprandial decreasing effect glucose and insulin concentrations in adult women. This effect was not evident for triglyceride concentration. Clinical trial registry: RBR-33wf46. Available in: http://www.ensaiosclinicos.gov.br/rg/RBR-33wf46/.",2019,"Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin.","['adult women', '40 women (20 normal weight and 20 grade I obese']","['http://www.ensaiosclinicos.gov.br/rg/RBR-33wf46', 'Yacon syrup', 'placebo', 'volunteers consumed breakfast +40\u202fg of placebo', 'breakfast +40\u202fg of yacon syrup', 'yacon syrup']","['postprandial glucose, insulin and triglyceride (TG) responses', 'postprandial glycemic response', 'Glucose and insulin concentrations', 'postprandial glucose and lipid profiles', 'triglyceride concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2713973', 'cui_str': 'yacon syrup'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",20.0,0.252225,"Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin.","[{'ForeName': 'Lia Silveira', 'Initials': 'LS', 'LastName': 'Adriano', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil; Department of Nutrition, University of Fortaleza, 60811-905 Fortaleza, CE, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Dionísio', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil. Electronic address: ana.dionisio@embrapa.br.'}, {'ForeName': 'Fernando Antônio Pinto de', 'Initials': 'FAP', 'LastName': 'Abreu', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Antônio Augusto Ferreira', 'Initials': 'AAF', 'LastName': 'Carioca', 'Affiliation': 'Department of Nutrition, University of Fortaleza, 60811-905 Fortaleza, CE, Brazil.'}, {'ForeName': 'Guilherme Julião', 'Initials': 'GJ', 'LastName': 'Zocolo', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Nedio Jair', 'Initials': 'NJ', 'LastName': 'Wurlitzer', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Claudia de Oliveira', 'Initials': 'CO', 'LastName': 'Pinto', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}, {'ForeName': 'Ariclécio Cunha', 'Initials': 'AC', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}, {'ForeName': 'Helena Alves de Carvalho', 'Initials': 'HAC', 'LastName': 'Sampaio', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.108682']
654,31045851,A Cluster Randomized Controlled Trial to Evaluate HeadCoach: An Online Mental Health Training Program for Workplace Managers.,"OBJECTIVE


Mental ill-health is now the leading cause of sickness absence and occupational incapacity in high-income countries. This study evaluated HeadCoach online manager training, designed to improve confidence, and managerial behaviors that create mentally healthy workplaces.
METHODS


A cluster randomized controlled trial was conducted comparing managers who received HeadCoach (N = 87) to waitlist control (N = 123). Managers' confidence and behavior were investigated at baseline, postintervention, and follow-up. Psychological distress of direct reports was evaluated.
RESULTS


Confidence significantly increased postintervention only; however, per-protocol analyses indicated a significant improvement for program completers compared with control at both time points. Responsive and preventive behaviors significantly improved. Psychological distress of direct reports remained unchanged.
CONCLUSIONS


HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health. The impact on direct reports remains unknown.",2019,HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health.,"['N\u200a=\u200a87) to waitlist control (N\u200a=\u200a123', 'mentally healthy workplaces']","['HeadCoach online manager training', 'HeadCoach']",['Psychological distress'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.102152,HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health.,"[{'ForeName': 'Aimée', 'Initials': 'A', 'LastName': 'Gayed', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia (Ms Gayed and Dr Mykletun); Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia (Ms Bryan, Dr Deady, Dr Mackinnon, Dr Christensen, and Dr Harvey); Centre for Population Health Research, Deakin University, Geelong, Victoria, Australia (Dr LaMontagne); School of Population and Global Health, The University of Melbourne, Melbourne, Australia (Dr LaMontagne and Dr Milner); School of Electrical and Information Engineering, University of Sydney, Sydney, Australia (Dr Calvo); Centre for Mental Health, University of Melbourne, Melbourne, Australia (Dr Mackinnon); Department of Mental Health and Suicide, Norwegian Institute of Public Health, Oslo, Norway (Dr Mykletun); Department of Community Medicine, University of Tromsø, Tromsø, Norway (Dr Mykletun); Centre for Work and Mental Health, Nordland Hospital Trust, Bodø, Norway (Dr Mykletun); Centre for Research and Education in Forensic Psychiatry and Psychology, Haukeland University Hospital, Bergen, Norway (Dr Mykletun); and Brain and Mind Centre & Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia (Dr Glozier).'}, {'ForeName': 'Bridget T', 'Initials': 'BT', 'LastName': 'Bryan', 'Affiliation': ''}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'LaMontagne', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Milner', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': ''}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Calvo', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackinnon', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Arnstein', 'Initials': 'A', 'LastName': 'Mykletun', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': ''}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001597']
655,31727514,Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort.,"PURPOSE


To understand if a new artificial tear, which is indicated for the treatment of both evaporative and aqueous deficient dry eye, is able to safely alleviate contact lens discomfort (CLD) in symptomatic soft contact lens (CL) wearers.
METHODS


This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears (Systane Complete) before and after CL use or no treatment. Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported) were evaluated at baseline and two weeks.
RESULTS


This study recruited 22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment. Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group. No significant between group differences were noted for any clinical signs at two weeks (all p > 0.29). No subject in either group reported any adverse events during the study.
CONCLUSIONS


Systane Complete was found to safely and significantly improve CL comfort in symptomatic CL wearers. Additional work is needed to better understand the mechanism(s) leading to improved comfort since tested clinical signs were unchanged.",2020,Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group.,"['adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores', 'symptomatic soft contact lens (CL) wearers', '22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment', 'Contact Lens Discomfort']",['artificial tears (Systane Complete) before and after CL use or no treatment'],"['clinical signs', 'adverse events', ""Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported"", 'CLDEQ-8 scores', 'SPEED scores', 'CL comfort']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]","[{'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C4542395', 'cui_str': 'Systane Complete'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",22.0,0.0508605,Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group.,"[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pucker', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States. Electronic address: apucker@uab.edu.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Quentin X', 'Initials': 'QX', 'LastName': 'Franklin', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Alanna', 'Initials': 'A', 'LastName': 'Nattis', 'Affiliation': 'Lindenhurst Eye Physicians & Surgeons, P.C., Babylon, NY, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lievens', 'Affiliation': 'Southern College of Optometry, Memphis, TN, United States.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.10.141']
656,31726954,Randomized controlled trial of the Circle of Security-Intensive intervention for mothers with postpartum depression: maternal unresolved attachment moderates changes in sensitivity.,"Postpartum depression is related to inadequately sensitive caregiving, putting infants at risk for insecure attachment. Therefore, promoting sensitive maternal caregiving and secure child attachment is particularly important in postpartum depressed mothers and their infants. In this randomized-controlled-trial, we evaluated the efficacy of the Circle of Security-Intensive (COS-I)-intervention in supporting maternal sensitivity and mother-infant-attachment compared to treatment-as-usual (TAU) with unresolved-maternal attachment as a moderator of treatment effect. Eligible mothers with infants ( N =72) 4-9 months-old were randomly assigned to treatment ( n =36 dyads). Infant attachment was rated at follow-up (child age 16-18 months) (Strange-Situation-procedure). Maternal sensitivity was measured at baseline and follow-up (Mini-Maternal-Behavior-Q-sort). Maternal-unresolved-attachment was assessed at baseline (Adult-Attachment-Interview). We found no significant differences between treatments in infant attachment nor changes in mothers' sensitivity. However, in COS-I, unresolved-mothers exhibited significantly more change in sensitivity than non-unresolved-mothers, whereas in TAU, the opposite was true. These findings may help to optimize clinical use of COS-I.",2020,Maternal sensitivity was measured at baseline and follow-up,"['postpartum depressed mothers and their infants', 'Eligible mothers with infants ( N =72) 4-9 months-old', 'mothers with postpartum depression']","['Circle of Security-Intensive intervention', 'Circle of Security-Intensive (COS-I)-intervention']","['sensitivity', 'Maternal sensitivity']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]","[{'cui': 'C0454802', 'cui_str': 'Cos (geographic location)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",36.0,0.0874871,Maternal sensitivity was measured at baseline and follow-up,"[{'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ramsauer', 'Affiliation': 'Medical School Hamburg MSH, University of Applied Sciences and Medical University , Hamburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mühlhan', 'Affiliation': 'Medical School Hamburg MSH, University of Applied Sciences and Medical University , Hamburg, Germany.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Lotzin', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf , Hamburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Achtergarde', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Muenster , Muenster, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf , Hamburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Krink', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Muenster , Muenster, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tharner', 'Affiliation': 'Department of Clinical Child and Family Studies, Vrije Universiteit Amsterdam , Amsterdam, The Netherlands.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Becker-Stoll', 'Affiliation': 'State Institute of Early Childhood Research (IFP) , München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nolte', 'Affiliation': 'Anna Freud Centre , London, UK.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Romer', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Muenster , Muenster, Germany.'}]",Attachment & human development,['10.1080/14616734.2019.1689406']
657,31730174,Low Circulating Levels of miR-451a in Girls with Polycystic Ovary Syndrome: Different Effects of Randomized Treatments.,"CONTEXT


Polycystic ovary syndrome (PCOS) is a prevalent disorder in adolescent girls, purportedly driven by hepato-visceral fat excess, and often followed by subfertility and type 2 diabetes.
OBJECTIVE


We studied the baseline microRNA (miRNA) profile of girls with PCOS, and the effects of a randomized treatment with an oral contraceptive (OC) or with spironolactone-pioglitazone-metformin (SPIOMET, aiming at loss of hepato-visceral fat excess) for 1 year.
DESIGN & PATIENTS


The miRNA profile was assessed by RNA sequencing in girls with PCOS who had participated in a randomized, open-label, single-center, pilot study (n = 31; age 15.7 years, body mass index (BMI) 23.1 kg/m2). Healthy age- and BMI-matched girls (n = 13) served as controls. Differentially expressed miRNAs were validated by RT-qPCR in the entire study population. Post-treatment ovulation rates were assessed by salivary progesterone in PCOS girls.
SETTING


Endocrinology Department, University Hospital.
RESULTS


Girls with PCOS, compared with controls, had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p, and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell cycle control. In the present study, miR-451a could diagnose PCOS with 100% sensitivity and 100% specificity. SPIOMET (but not OC) was accompanied by on-treatment normalization of the miRNA profile in girls with PCOS; miR-451a concentrations after 1 year on OC or SPIOMET treatment associated closely (r = 0.66; P < .0001) with post-treatment ovulation rates.
CONCLUSION


SPIOMET treatment for 1 year normalizes the miRNA profile of girls with PCOS. Circulating miR-451a may become a biomarker to guide the diagnosis and treatment of PCOS in adolescence.",2020,"RESULTS


Girls with PCOS -as compared to controls- had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell-cycle control.","['girls with PCOS', 'Girls with Polycystic Ovary Syndrome', 'girls with PCOS who had participated in a randomized, open-label, single-center, pilot study (n=31; age 15.7 years, BMI 23.1 Kg/m2', 'Endocrinology Department, University Hospital', '1 year normalizes the miRNA profile of girls with PCOS', 'Healthy age- and BMI-matched girls (n=13) served as controls']",['oral contraceptive (OC) or with spironolactone-pioglitazone-metformin'],['Post-treatment ovulation rates'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0587463', 'cui_str': 'Endocrinology department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",,0.0900779,"RESULTS


Girls with PCOS -as compared to controls- had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell-cycle control.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Díaz', 'Affiliation': 'Institut de Recerca Pediàtric Hospital Sant Joan de Déu, University of Barcelona, Esplugues, Barcelona, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Bassols', 'Affiliation': 'Maternal-Fetal Metabolic Research Group, Girona Institute for Biomedical Research (IDIBGI), Salt, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'López-Bermejo', 'Affiliation': 'Pediatric Endocrinology Research Group, Girona Institute for Biomedical Research (IDIBGI) and Dr. Josep Trueta Hospital, Girona, Spain.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'de Zegher', 'Affiliation': 'Department of Development & Regeneration, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ibáñez', 'Affiliation': 'Institut de Recerca Pediàtric Hospital Sant Joan de Déu, University of Barcelona, Esplugues, Barcelona, Spain.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz204']
658,31704948,Statin Short-term Inhibition of Insulin Sensitivity and Secretion During Acute Phase of ST-Elevation Myocardial Infarction.,"Hyperglycemia during myocardial infarction (MI) has a strong and direct association with mortality. In stable patients and experimental models, statins favor the elevation of glycaemia. The present study investigated whether short-course treatment with statins during MI can influence glucose homeostasis and thus the clinical outcome. In this prospective study, euglycemic hyperinsulinemic clamp (EHC) was performed at second (D2) and sixth (D6) day after MI in patients randomized to simvastatin (S)10 or 80 mg/day during hospitalization (n = 27). In addition, patients (n = 550) were treated without (WS) or with simvastatin (S) at 20, 40 or 80 mg/day had HOMA2S on admission (D1) and fifth (D5) day after MI. According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025). Consistently, the changes in HOMA2S between D1 and D5 were 40 ± 145% (WS), 22 ± 117% (S20), 16 ± 61% (S40) and -2% ± 88% (S80) (p = 0.001). In conclusion, statin during the acute phase of MI reduces insulin sensitivity in a dose-dependent manner.",2019,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).",[],"['simvastatin', 'euglycemic hyperinsulinemic clamp (EHC', 'simvastatin (S)10']","['insulin sensitivity', 'Hyperglycemia', 'Insulin Sensitivity and Secretion']",[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",550.0,0.0261715,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).","[{'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil. andreisposito@gmail.com.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Moura', 'Affiliation': 'Department of Medicine, Weill-Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Alessandra M', 'Initials': 'AM', 'LastName': 'Campos-Staffico', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Riobaldo M R', 'Initials': 'RMR', 'LastName': 'Cintra', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Osorio R', 'Initials': 'OR', 'LastName': 'Almeida', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Quinaglia E Silva', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}]",Scientific reports,['10.1038/s41598-019-52111-x']
659,30765503,The Electronic Asthma Management System (eAMS) improves primary care asthma management.,"A high prevalence of suboptimal asthma control is attributable to known evidence-practice gaps. We developed a computerised clinical decision support system (the Electronic Asthma Management System (eAMS)) to address major care gaps and sought to measure its impact on care in adults with asthma.This was a 2-year interrupted time-series study of usual care (year 1)  versus  eAMS (year 2) at three Canadian primary care sites. We included asthma patients aged ≥16 years receiving an asthma medication within the last 12 months. The eAMS consisted of a touch tablet patient questionnaire completed in the waiting room, with real-time data processing producing electronic medical record-integrated clinician decision support.Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)). Time-series analysis indicated a 30.5% increase in physician visits with action plan delivery with the intervention (p<0.0001). Assessment of asthma control level increased from 173 out of 3497 (4.9%) to 849 out of 3062 (27.7%) eligible visits (adjusted OR 8.62 (95% CI 5.14-12.45)). Clinicians escalated controller therapy in 108 out of 3422 (3.2%) baseline visits  versus  126 out of 3240 (3.9%) intervention visits (p=0.12). At baseline, a short-acting β-agonist alone was added in 62 visits and a controller added in 54 visits; with the intervention, this occurred in 33 and 229 visits, respectively (p<0.001).The eAMS improved asthma quality of care in real-world primary care settings. Strategies to further increase clinician uptake and a randomised controlled trial to assess impact on patient outcomes are now required.",2019,Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)).,"['adults with asthma', 'asthma patients aged ≥16\u2005years receiving an asthma medication within the last 12\u2005months']","['usual care (year 1)  versus  eAMS', 'computerised clinical decision support system (the Electronic Asthma Management System (eAMS', 'Electronic Asthma Management System (eAMS']","['physician visits', 'asthma quality of care', 'asthma control level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3497.0,0.0463128,Action plan delivery (primary outcome) improved from zero out of 412 (0%) to 79 out of 443 (17.8%) eligible patients (absolute increase 0.18 (95% CI 0.14-0.22)).,"[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada guptas@smh.ca.""}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Dept of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Dept of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Health Quality Innovation Collaborative, Brampton, ON, Canada.'}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'Boulet', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Universite Laval, Québec, QC, Canada.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Kaplan', 'Affiliation': 'Family Physician Airways Group of Canada, Edmonton, AB, Canada.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Lebovic', 'Affiliation': ""Applied Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mamdani', 'Affiliation': ""Li Ka Shing Centre for Healthcare Analytics Research and Training (LKS-CHART), Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Straus', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}]",The European respiratory journal,['10.1183/13993003.02241-2018']
660,30792342,Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial.,"We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI -0.89-5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19-10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.",2019,No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care.,"['aged ≥40\u2005years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD', 'primary care', '272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase', '43 general practices in Australia', 'Adults with a history of smoking and/or COPD']","['Interdisciplinary COPD intervention', 'smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase', 'interdisciplinary, primary care-based model of care']","['SGRQ', ""changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function"", 'change in CAT, dyspnoea, smoking abstinence or lung function']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]",272.0,0.102985,No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care.,"[{'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Abramson', 'Affiliation': 'Dept of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Southern Academic Primary Care Research Unit, Dept of General Practice, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Discipline of Physiotherapy, La Trobe University, Alfred Health, and Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'The Nossal Institute for Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Eustace', 'Affiliation': 'Eastern Melbourne PHN (EMPHN), Melbourne, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Dept of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Lung Foundation Australia (LFA), Milton, Australia.'}, {'ForeName': 'Narelle S', 'Initials': 'NS', 'LastName': 'Cox', 'Affiliation': 'Discipline of Physiotherapy, La Trobe University and Institute for Breathing and Sleep, Melbourne, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia johnson.george@monash.edu.'}]",The European respiratory journal,['10.1183/13993003.01530-2018']
661,31030594,Evaluation of efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis.,"Background:  There has been an alarming increase in recalcitrant dermatophytosis in recent years. The standard treatment guidelines no longer seem effective in achieving clearance and results in high failure rates. Objective:  To evaluate the efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis. Methods:  Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei were randomly divided into three groups and given terbinafine 250 mg, itraconazole 200 mg and a combination of both once daily taken on the same day respectively for 3 weeks. Partial responders at the end of the therapy were given same treatment for additional 3 weeks. Clinical parameters namely itching, erythema, and scaling were evaluated at baseline, 3, 6, and 9 weeks. Adverse effects were noted at the end of therapy. Results:  Maximum clinical and mycological cure was achieved in group III (receiving combination therapy) (90%) followed by group II (receiving itraconazole) (50%) and group I (receiving terbinafine) (35%). The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects. Conclusions:  The combination of systemic terbinafine and itraconazole therapy may be an effective and safe therapeutic strategy in the management of dermatophytosis.",2020,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
",['Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei'],"['terbinafine and itraconazole therapy', 'terbinafine and itraconazole combination therapy', 'itraconazole', 'terbinafine 250\u2009mg, itraconazole', 'terbinafine and itraconazole', 'terbinafine']","['Clinical parameters namely itching, erythema, and scaling', 'Adverse effects', 'mycological cure', 'efficacy and safety']","[{'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040252', 'cui_str': 'Tinea corporis (disorder)'}]","[{'cui': 'C0956383', 'cui_str': 'Terbinafine, (Z)-isomer'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1596471', 'cui_str': 'terbinafine 250 MG [Lamisil]'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0174065,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Bhalla', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Gurvinder P', 'Initials': 'GP', 'LastName': 'Thami', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Chander', 'Affiliation': 'Department of Microbiology, Government Medical College and Hospital, Chandigarh, India.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612835']
662,31690740,Early evening light mitigates sleep compromising physiological and alerting responses to subsequent late evening light.,"The widespread use of electric light and electronic devices has resulted in an excessive exposure to light during the late-evening and at night. This late light exposure acutely suppresses melatonin and sleepiness and delays the circadian clock. Here we investigate whether the acute effects of late-evening light exposure on our physiology and sleepiness are reduced when this light exposure is preceded by early evening bright light. Twelve healthy young females were included in a randomised crossover study. All participants underwent three evening (18:30-00:30) sessions during which melatonin, subjective sleepiness, body temperature and skin blood flow were measured under different light conditions: (A) dim light, (B) dim light with a late-evening (22:30-23:30) light exposure of 750 lx, 4000 K, and (C) the same late-evening light exposure, but now preceded by early-evening bright light exposure (18.30-21.00; 1200 lx, 4000 K). Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim. Interestingly, these effects were reduced when the late-evening light was preceded by an early evening 2.5-hour bright light exposure. Thus daytime and early-evening exposure to bright light can mitigate some of the sleep-disruptive consequences of light exposure in the later evening.",2019,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,['Twelve healthy young females'],['electric light and electronic devices'],"['melatonin levels and subjective sleepiness', 'subjective sleepiness, body temperature and skin blood flow', 'larger skin temperature gradients']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",12.0,0.029679,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,"[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Te Kulve', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands. marijetekulve@gmail.com.'}, {'ForeName': 'Luc J M', 'Initials': 'LJM', 'LastName': 'Schlangen', 'Affiliation': 'Intelligent Lighting Institute, Department of Human Technology Interaction, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Wouter D', 'Initials': 'WD', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-52352-w']
663,31493749,Examining motivational interviewing's effect on confidence and commitment using daily data.,"Mechanisms of behavior change (MOBC) within Motivational Interviewing (MI) are thought to operate via both relational and technical elements. These elements are hypothesized to increase client motivation and self-efficacy for change and subsequently decrease drinking. Only partial support for this causal chain exists, particularly when using within-session change talk as the primary intervening variable. This study explored whether commitment to moderate or abstain from drinking and confidence to moderate drinking in the next day measured via ecological momentary assessment (EMA) provided alternative support for the theory. Data were from a pilot randomized controlled trial testing active ingredients of MI. Problem drinkers (N = 89) seeking to moderate their drinking were randomly assigned to one of the three conditions: 1) MI; 2) Spirit only MI (SOMI), consisting of non-directive elements of MI, e.g., reflective listening; and 3) a non-therapy control. Participants completed daily EMA that measured confidence, both types of commitment, and drinks per day for a week prior to and during seven weeks of treatment. Hypotheses were not supported, and results were unexpected. Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment. All daily measures significantly predicted drinking; however, the MI group did not demonstrate a stronger relationship between the intervening variables and drinking, as hypothesized. Instead, participants in SOMI yielded the strongest relationship between daily commitment to abstain and drinking compared to the other two conditions. Multiple possible explanations for the unexpected findings are discussed.",2019,Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment.,['Problem drinkers (N\u202f=\u202f89) seeking to moderate their drinking'],"['Motivational Interviewing (MI', 'MI; 2) Spirit only MI (SOMI), consisting of non-directive elements of MI, e.g., reflective listening; and 3) a non-therapy control']",['client motivation and self-efficacy'],"[{'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0206516,Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment.,"[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kuerbis', 'Affiliation': 'Silberman School of Social Work, Hunter College at the City University of New York, New York, NY 10035, USA. Electronic address: ak1465@hunter.cuny.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Sijing', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, Great Neck, NY 11021, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Morgenstern', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, Great Neck, NY 11021, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.04.038']
664,31724703,Reducing Attentional Bias in Individuals With Alcohol Use Disorders With a Tablet Application: A Randomized Controlled Trial Pilot Study.,"AIMS


Cognitive bias modification (CBM) training has been considered a promising and effective intervention tool for reducing cognitive biases toward alcohol. However, the link between the cognitive process and actual behavior remains statistically insignificant because computerized tasks do not have sufficient ecological validity and suffer from high dropout rates. The recent development of 'serious games' has shown encouraging results in maintaining adherence to health-related interventions. We aim to evaluate a CBM program using a gamified attentional bias (AB) training procedure on a touchpad for individuals with alcohol use disorders.
METHODS


Forty-one patients were included in this study, 33 of whom displayed an AB and were randomly assigned into the 'CBM group' (N = 18, 16.7% women) or 'Memory group'-which involved playing a memory game-(N = 15, no woman). Eight other participants (12.5% women) with no AB comprised the 'Without AB group'. Efficacy was assessed for AB, craving, and inhibition and attentional capacities before and after the program.
RESULTS


We observed that the reduction of AB was higher for the 'CBM group' (Mbefore = 153.61, SD = 172.21; Mafter = 18.00, SD = 77.71; t (17) = 4.21, P = 0.001) than for the 'Memory group' (Mbefore = 73.20, SD = 66.65; Mafter =42.47, SD = 113.77; ts < 1). The analysis showed that for the 'Without AB group', there was no significant difference in AB (t (7) = -2.15, P = .07) after the program.
CONCLUSIONS


This study demonstrated an increased reduction of AB for patients included in the CBM program on a touchpad than for patients playing only a memory game.",2020,"The analysis showed that for the 'Without AB group', there was no significant difference in AB (t (7) = ","['Individuals With Alcohol Use Disorders With a Tablet Application', 'individuals with alcohol use disorders', ""Forty-one patients were included in this study, 33 of whom displayed an AB and were randomly assigned into the 'CBM group' (N\xa0=\xa018, 16.7% women) or""]","['CBM program using a gamified attentional bias (AB) training procedure', 'Cognitive bias modification (CBM) training', ""Memory group'-which involved playing a memory game-(N\xa0""]","['AB, craving, and inhibition and attentional capacities', 'AB', 'reduction of AB', 'Attentional Bias']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",41.0,0.0504869,"The analysis showed that for the 'Without AB group', there was no significant difference in AB (t (7) = ","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Flaudias', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}, {'ForeName': 'Oulmann', 'Initials': 'O', 'LastName': 'Zerhouni', 'Affiliation': 'Université Paris Nanterre, Laboratoire Parisien de Psychologie Sociale, 200 avenue de la République. F-92000 Nanterre, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chakroun-Baggioni', 'Affiliation': 'Université Clermont Auvergne, CNRS UMR 6024, LAPSCO, 34 Avenue Carnot F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Pires', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'De Chazeron', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}, {'ForeName': 'Pierre Michel', 'Initials': 'PM', 'LastName': 'Llorca', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Brousse', 'Affiliation': 'Clermont-Ferrand, Pôle Psychiatrie B, CHU Clermont-Ferrand, 58 Rue Montalembert F-63001 Clermont-Ferrand, France.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agz080']
665,31708608,Introducing and Prospective Efficacy Comparison of an Innovative and Affordable Technique for the Treatment of Distal Radius Fractures.,"Background


There are different treatments as well as controversies surrounding the adequate treatment for Distal Radius Fractures (DRF). In the absence of enough evidence[HYPHEN]base data regarding clinical effectiveness of available treatments, cost should be considered as an essential factor in selecting the surgical technique for DRF treatment. The goal of this study is introducing an improved and modified pin[HYPHEN]and[HYPHEN]plaster (MP&P) technique as an affordable alternative for treatment of DRF. This study also assesses and compares the outcomes of DRF treatment by using the introduced method versus external fixation (EF) technique.
Methods


In this clinical cohort study, 98 patients presenting with closed DRF Types III or IV, randomly were classified into two modified P&P (50 patients) and EF (48 patients) groups and assessed for functional, clinical, radiographic and overall outcome at the time, 2, 10 and 22 months after surgery. They were also followed[HYPHEN]up for up to 3 years to determine the rate of complications.
Results


Eighty one percent of EF and 86% of MP&P group were female. The average ages in the EF and MP&P groups were 44.9 ± 12.4 and 46.1 ± 5.4, respectively. Around 70% of the patients in each group had a Type III fracture, and 30% had Type IV. The rate of complications was higher among EF group patients (seven major and seven minor complications) compared to the MP&P (only 4 minor complications), however the difference between two groups regarding the complications and treatment outcome were insignificant, except in extension ROM and the quick[HYPHEN]dash score (only in two and four months follow up visits) and also returning to work (only in two month follow up visit).
Conclusion


This study introduces a modified P&P technique that protects the transverse palmar curvature, prevents the collapse of the distal radius, and simplifies casting, thereby obviating a full arm cast and mitigating elbow stiffness in patient outcomes. This modified technique could be considered as a more cost[HYPHEN]conscious alternative to external fixation for patients with distal radius fractures.",2019,"The rate of complications was higher among EF group patients (seven major and seven minor complications) compared to the MP&P (only 4 minor complications), however the difference between two groups regarding the complications and treatment outcome were insignificant, except in extension ROM and the quick[HYPHEN]dash score (only in two and four months follow up visits) and also returning to work (only in two month follow up visit).
","['Distal Radius Fractures', 'patients with distal radius fractures', '98 patients presenting with closed DRF Types III or IV']","['MP&P', 'introduced method versus external fixation (EF) technique', 'modified pin[HYPHEN]and[HYPHEN]plaster (MP&P) technique']","['Type III fracture', 'rate of complications', 'extension ROM']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}]","[{'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",98.0,0.0246109,"The rate of complications was higher among EF group patients (seven major and seven minor complications) compared to the MP&P (only 4 minor complications), however the difference between two groups regarding the complications and treatment outcome were insignificant, except in extension ROM and the quick[HYPHEN]dash score (only in two and four months follow up visits) and also returning to work (only in two month follow up visit).
","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Yazdanshenas', 'Affiliation': 'Department of Orthopedic Surgery, Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Eleby Rudolph', 'Initials': 'ER', 'LastName': 'Washington', 'Affiliation': 'Department of Orthopedic Surgery, Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Madadi', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medicine and Science, Tehran, Iran.'}, {'ForeName': 'Firooz', 'Initials': 'F', 'LastName': 'Madadi', 'Affiliation': 'Department of Orthopedic Surgery, Shahid Beheshti University of Medicine and Science, Tehran, Iran.'}, {'ForeName': 'Arya Nick', 'Initials': 'AN', 'LastName': 'Shamie', 'Affiliation': 'Department of Orthopedic Surgery, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Francis John', 'Initials': 'FJ', 'LastName': 'Hornicek', 'Affiliation': 'Department of Orthopedic Surgery, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Kodi', 'Initials': 'K', 'LastName': 'Azari', 'Affiliation': 'Department of Orthopedic Surgery, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}]",Journal of orthopaedics,['10.1016/j.jor.2019.05.007']
666,31014112,Reducing Health-Related Stigma Through Narrative Messages.,"Public stigma characterizes three leading health issues: prescription opioid addiction, obesity, and cigarette smoking. Attributions of individual responsibility are often embedded in negative public attitudes around these issues and can be important to stigma's development and reduction. Research suggests that narrative messages may hold promise for influencing attributions and stigma in these health contexts. Using a national sample of American adults from an online panel (N = 5,007), we conducted a survey-embedded randomized experiment, assigning participants to read one of six messages about one of three health issues. All participants read a statement detailing the magnitude of their assigned health problem, after which some respondents received a short inoculation message (serving as a comparison group) or a narrative message emphasizing external factors while acknowledging personal responsibility for the issue. Some participants also read a counter message emphasizing personal responsibility for the health issue to replicate competitive messaging environments surrounding these issues. Relative to those who received only the magnitude of problem message (comparison group 1) or the magnitude of problem and inoculation messages (comparison group 2), the narrative message reduced prescription opioid addiction stigma and increased attributions of responsibility to groups beyond the individual. Narrative effects were mixed for obesity, had no effect on attributions or stigma around cigarette smoking, and were generally consistent whether or not respondents received a counter message. Narrative messages may be a promising approach for shifting responsibility attributions and reducing public stigma around prescription opioid addiction, and may have some relevance for obesity stigma-reduction efforts.",2020,"Narrative effects were mixed for obesity, had no effect on attributions or stigma around cigarette smoking, and were generally consistent whether or not respondents received a counter message.","['American adults from an online panel (N\xa0=\xa05,007']",['short inoculation message (serving as a comparison group) or a narrative message emphasizing external factors while acknowledging personal responsibility for the issue'],['attributions or stigma around cigarette smoking'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0279611,"Narrative effects were mixed for obesity, had no effect on attributions or stigma around cigarette smoking, and were generally consistent whether or not respondents received a counter message.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Heley', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Alene', 'Initials': 'A', 'LastName': 'Kennedy-Hendricks', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University.'}, {'ForeName': 'Colleen L', 'Initials': 'CL', 'LastName': 'Barry', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health.'}]",Health communication,['10.1080/10410236.2019.1598614']
667,31541874,Peripheral proinflammatory markers are upregulated in abstinent alcohol-dependent patients but are not affected by cognitive bias modification: Preliminary findings.,"BACKGROUND


Inflammatory pathways are known to be negatively affected in patients with alcohol use disorder (AUD). Cognitive bias modification (CBM), an emerging behavioral treatment that involves the 're-training' of cognitive biases using computerized tasks, has been reported to reduce alcohol craving and relapse rates. The aim of this study was to compare peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP in AUD patients versus controls and to identify whether CBM treatment affected these biomarkers in AUD patients.
METHODS


This 3-week double-blind randomized controlled study tested 36 male abstinent AUD patients receiving CBM or placebo-training, who were also compared to 18 male healthy controls. The approach avoidance task (AAT) was used to test the AUD patients before and after training. CBM training took place over 6 sessions, using a joystick-based approach-avoidance task. Blood samples were collected after the pre- and post-AAT test sessions for the AUD groups, and during an outpatient appointment with the controls.
RESULTS


AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031). No changes in the CBM versus placebo groups were noted in IL-18, TNF-α and CRP concentrations following pre-post change or within group pretest- posttest analysis. IL-6 and IL-1β levels fell under the lower detection limit, thus were not included in the final analyses.
CONCLUSIONS


This study confirms that the inflammatory system is altered in AUD. This was the first study that investigated whether CBM training affected proinflammatory markers in AUD patients.",2019,"RESULTS


AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","['AUD patients', '18 male healthy controls', 'patients with alcohol use disorder (AUD', '36 male abstinent AUD patients receiving']","['CBM', 'IL-6', 'CBM training', 'placebo', 'Cognitive bias modification (CBM', 'CBM or placebo-training']","['IL-18, TNF-α and CRP concentrations', 'proinflammatory markers', 'peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP', 'Blood samples', 'alcohol craving and relapse rates', 'Peripheral proinflammatory markers', 'plasma levels of TNF- α']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",18.0,0.108888,"RESULTS


AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","[{'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Corinde E', 'Initials': 'CE', 'LastName': 'Wiers', 'Affiliation': 'Laboratory of Neuroimaging, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bermpohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Germany; Berlin School of Mind and Brain, Humboldt Universität zu Berlin, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, USA; Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107553']
668,31685853,An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke.,"We have previously shown the safety and feasibility of vagus nerve stimulation (VNS) paired with upper-limb rehabilitation after ischemic stroke. In this exploratory study, we assessed whether clinical and brain MRI variables predict response to treatment. We used data from two completed randomised and blinded clinical trials (N = 35). All participants had moderate to severe upper-limb weakness and were randomised to 6-weeks intensive physiotherapy with or without VNS. Participants had 3 T brain MRI at baseline. The primary outcome was change in Fugl-Meyer Assessment, upper-extremity score (FMA-UE) from baseline to the first day after therapy completion. We used general linear regression to identify clinical and brain MRI predictors of change in FMA-UE. VNS-treated participants had greater improvement in FMA-UE at day-1 post therapy than controls (8.63 ± 5.02 versus 3.79 ± 5.04 points, t = 2.83, Cohen's d = 0.96, P = 0.008). Higher cerebrospinal fluid volume was associated with less improvement in FMA-UE in the control but not VNS group. This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group. Responders in the VNS group had more severe arm impairment at baseline than responders to control. A phase III trial is now underway to formally determine whether VNS improves outcomes and will explore whether these differ in people with more severe baseline upper-limb disability and cerebrovascular disease.",2019,This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group.,['All participants had moderate to severe upper-limb weakness'],"['VNS', 'vagus nerve stimulation (VNS) paired with upper-limb rehabilitation', 'Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation', '6-weeks intensive physiotherapy with or without VNS']","['FMA-UE', 'severe arm impairment', 'Higher cerebrospinal fluid volume', 'change in Fugl-Meyer Assessment, upper-extremity score (FMA-UE']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3888791', 'cui_str': 'Cerebrospinal fluid volume'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.277045,This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group.,"[{'ForeName': 'David Alexander', 'Initials': 'DA', 'LastName': 'Dickie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom. david.dickie@glasgow.ac.uk.'}, {'ForeName': 'Teresa Jacobson', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': 'School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Charlestown Navy Yard, 36 1st Avenue, Boston, MA, 02129, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pierce', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'Navzer', 'Initials': 'N', 'LastName': 'Engineer', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Tarver', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-52092-x']
669,31690824,Fear expression is suppressed by tyrosine administration.,"Animal studies have demonstrated that catecholamines regulate several aspects of fear conditioning. In humans, however, pharmacological manipulations of the catecholaminergic system have been scarce, and their primary focus has been to interfering with catecholaminergic activity after fear acquisition or expression had taken place, using L-Dopa, primarily, as catecholaminergic precursor. Here, we sought to determine if putative increases in presynaptic dopamine and norepinephrine by tyrosine administered before conditioning could affect fear expression. Electrodermal activity (EDA) of 46 healthy participants (24 placebo, 22 tyrosine) was measured in an instructed fear task. Results showed that tyrosine abolished fear expression compared to placebo. Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood. Therefore, the effect of tyrosine on fear expression cannot be attributed to these factors. Taken together, these findings provide evidence that the catecholaminergic system influences fear expression in humans.",2019,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","['46 healthy participants (24 placebo, 22 tyrosine) was measured in\xa0an instructed fear task']",['placebo'],"['Electrodermal activity (EDA', 'Fear expression', 'fear expression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",46.0,0.0189243,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Soranzo', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK. luca.aquili@shu.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-52610-x']
670,31696644,"Effect of different pulse numbers of transcranial magnetic stimulation on motor cortex excitability: Single-blind, randomized cross-over design.","AIMS


We aimed to investigate the effect of different pulse numbers of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the motor cortex on cortical excitability in healthy participants.
METHODS


Fifteen healthy participants received 600 and 1200 pulses of 5-Hz rTMS on separate days in a random order. Stimulation (duration, 2 seconds and interval, 1 seconds) was delivered over the left primary motor cortex for the hand, at 90% of resting motor threshold (rMT). The rMT and motor evoked potential (MEP) were measured before stimulation, and at 0 and 30 minutes after rTMS.
RESULTS


No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266). Compared with baseline, MEP was increased significantly at 0 (P < .001) and 30 minutes (P < .001) after stimulation. After stimulation, rMT was decreased at 0 minute for the 600 and 1200 pulse conditions (P < .001), but had recovered by 30 minutes (P = .073).
CONCLUSION


Subthreshold 5-Hz rTMS increased motor cortex excitability in healthy humans. However, the number of pulses may exhibit a ceiling effect in that beyond a certain point, that is, increasing the number of pulses may exhibit no further increase in cortical excitability.",2019,No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266).,"['healthy participants', 'Fifteen healthy participants received 600 and 1200 pulses of', 'healthy humans']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', '5-Hz rTMS', 'rTMS', 'Subthreshold 5-Hz', 'transcranial magnetic stimulation']","['MEP', 'cortical excitability', 'rMT', 'rMT and motor evoked potential (MEP', 'motor cortex excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",15.0,0.240525,No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266).,"[{'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Xuan', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zu-Lin', 'Initials': 'ZL', 'LastName': 'Dou', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Lan', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Wen', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13248']
671,31719675,Longitudinal neovascular changes on optical coherence tomography angiography in proliferative diabetic retinopathy treated with panretinal photocoagulation alone versus with intravitreal conbercept plus panretinal photocoagulation: a pilot study.,"PURPOSE


To investigate the longitudinal changes in neovascularization of the retinal elsewhere (NVE) size on optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR) treated by panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP.
METHODS


A prospective pilot study. Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included. They were assigned to receive PRP alone (PRP group) or intravitreal conbercept injection plus PRP (combination group). Ophthalmic examinations, including BCVA and OCTA to measure the NVE size, were performed at baseline before each PRP session, and at 1, 3, and 6 months.
RESULTS


Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group. There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline. In both groups, there was a significant (P < 0.05) NVE size reduction during the majority of study visits, with the reduction observed in the combination group significantly larger than that in the PRP group. No significant BCVA changes were observed in either groups, except that in the PRP group, the BCVA at 3 months was significantly improved (P < 0.05). No deaths or unexpected adverse events (AEs) were reported.
CONCLUSIONS


Intravitreal conbercept plus PRP was more effective than PRP monotherapy in NVE regression. Precise quantification of the NVE area by OCTA makes it a useful tool for monitoring the response of retinal neovascular lesions to the therapy.",2020,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","['proliferative diabetic retinopathy treated with', 'Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included', 'proliferative diabetic retinopathy (PDR', 'Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group']","['optical coherence tomography angiography', 'intravitreal conbercept plus panretinal photocoagulation', 'PRP alone (PRP group) or intravitreal conbercept injection plus PRP', 'panretinal photocoagulation alone', 'panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP', 'optical coherence tomography angiography (OCTA']","['No deaths or unexpected adverse events (AEs', 'NVE size reduction', 'BCVA changes', 'BCVA and OCTA to measure the NVE size', 'BCVA']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",44.0,0.0175467,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yuweihongeye@foxmail.com.'}]","Eye (London, England)",['10.1038/s41433-019-0628-3']
672,31719084,Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate 'Lifestyle Africa'.,"INTRODUCTION


Low and middle-income countries like South Africa are experiencing major increases in burden of non-communicable diseases such as diabetes and cardiovascular conditions. However, evidence-based interventions to address behavioural factors related to these diseases are lacking. Our study aims to adapt the CDC's National Diabetes Prevention Program (DPP) within the context of an under-resourced urban community in Cape Town, South Africa.
METHODS/ANALYSIS


The new intervention ( Lifestyle Africa ) consists of 17 weekly sessions delivered by trained community health workers (CHWs). In addition to educational and cultural adaptations of DPP content, the programme adds novel components of text messaging and CHW training in Motivational Interviewing. We will recruit overweight and obese participants (body mass index ≥25 kg/m 2 ) who are members of 28 existing community health clubs served by CHWs. In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care. After year 1, usual care participants will also receive the intervention and both groups will be followed for another year. The primary outcome analysis will compare percentage of baseline weight loss at year 1. Secondary outcomes will include diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life. We will also assess potential psychosocial mediators/moderators as well as cost-effectiveness of the programme.
ETHICS/DISSEMINATION


Ethical approval was obtained from the University of Cape Town and Children's Mercy. Results will be submitted for publication in peer-reviewed journals and training curricula will be disseminated to local stakeholders.
TRIAL REGISTRATION NUMBER


NCT03342274.",2019,"In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care.","['overweight and obese participants (body mass index ≥25\u2009kg/m 2 ) who are members of 28 existing community health clubs served by CHWs', 'under-resourced urban community in Cape Town, South Africa', ""University of Cape Town and Children's Mercy""]","['intervention or usual care', 'new intervention ( Lifestyle Africa ) consists of 17 weekly sessions delivered by trained community health workers (CHWs']","['diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life', 'percentage of baseline weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]",28.0,0.119344,"In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care.","[{'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA dcatley@cmh.edu.""}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Puoane', 'Affiliation': 'University of the Western Cape School of Public Health, Cape Town, South Africa.'}, {'ForeName': 'Lungiswa', 'Initials': 'L', 'LastName': 'Tsolekile', 'Affiliation': 'University of the Western Cape School of Public Health, Cape Town, South Africa.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Heatlh Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kandace', 'Initials': 'K', 'LastName': 'Fleming', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence, Kansas, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': 'Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Penn State College of Health and Human Development, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Estelle V', 'Initials': 'EV', 'LastName': 'Lambert', 'Affiliation': 'Research Centre for Health through Physical Activity, Lifestyle and Sport (HPALS), Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Levitt', 'Affiliation': 'Department of Medicine and Chronic Disease Initiative for Africa, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': 'Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.'}]",BMJ open,['10.1136/bmjopen-2019-031400']
673,31720889,A Randomized Control Trial of Thromboelastography-Guided Transfusion in Cirrhosis for High-Risk Invasive Liver-Related Procedures.,"BACKGROUND AND AIM


Hemostasis in cirrhosis is dynamic and balanced. Thromboelastography (TEG) assesses global coagulation status. We aimed to assess whether TEG-guided blood product transfusions result in lower blood product requirements in patients with cirrhosis undergoing invasive liver-related procedures as compared to the conventional standard of care (SOC).
METHODS


In this open-label, randomized controlled trial, cirrhosis patients with coagulopathy, undergoing invasive liver-related procedures, were randomized to either TEG-guided blood product transfusion or SOC. The primary outcome was difference in the amount of fresh frozen plasma (FFP) and platelet units transfused between the two groups. The secondary outcome was procedure-related bleeding complications within 5 days and any complications until 28 days.
RESULTS


From November 2017 till June 2019, 58 patients were recruited (29: TEG and 29: SOC). Most common procedures performed were percutaneous liver biopsy (n = 48), followed by transjugular intrahepatic portosystemic shunt (n = 2), percutaneous acetic acid injection (n = 2), and transarterial chemoembolization (n = 2). There were no differences in baseline demographics, hemostatic profile, and types of procedures between the two groups. Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001). In TEG group, six (20.7%) received FFP (P = 0.753 vs. SOC), two (6.9%) received platelets (P < 0.001 vs. SOC), and 1(3.4%) patient received both FFP and platelet (P ≥ 0.999 vs. SOC) transfusion. None of the patients in either group developed procedure-related bleeding complications until 5 days post-procedure. The complication rates at 28-day follow-up were similar between the groups.
CONCLUSION


TEG-guided blood product transfusion strategy reduces blood product transfusion without increased risk of bleeding in cirrhotic patients undergoing invasive liver-related procedures (CTRI/2017/12/010822).",2020,Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001).,"['patients with cirrhosis undergoing invasive liver-related procedures', 'From November 2017 till June 2019, 58 patients were recruited (29: TEG and 29: SOC', 'cirrhotic patients undergoing invasive liver-related procedures (CTRI/2017/12/010822', 'cirrhosis patients with coagulopathy, undergoing invasive liver-related procedures', 'Cirrhosis for High-Risk Invasive Liver-Related Procedures']","['transjugular intrahepatic portosystemic shunt', 'TEG', 'TEG-guided blood product transfusions', 'TEG-guided blood product transfusion strategy', 'TEG-guided blood product transfusion or SOC', 'percutaneous liver biopsy', 'Thromboelastography (TEG', 'Thromboelastography-Guided Transfusion', 'percutaneous acetic acid injection', 'transarterial chemoembolization']","['FFP', 'amount of fresh frozen plasma (FFP) and platelet units transfused', 'complication rates', 'procedure-related bleeding complications', 'baseline demographics, hemostatic profile, and types of procedures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0558534', 'cui_str': 'Percutaneous liver biopsy (procedure)'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",58.0,0.188769,Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001).,"[{'ForeName': 'Sudheer K', 'Initials': 'SK', 'LastName': 'Vuyyuru', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Achintya D', 'Initials': 'AD', 'LastName': 'Singh', 'Affiliation': 'Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shivanand R', 'Initials': 'SR', 'LastName': 'Gamanagatti', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gyanranjan', 'Initials': 'G', 'LastName': 'Rout', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gunjan', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shalimar', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India. drshalimar@yahoo.com.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05939-2']
674,30998422,Clinical assessment of topical erythromycin gel with and without zinc acetate for treating mild-to-moderate acne vulgaris.,"Purpose:  Erythromycin is an effective topical antibiotic for treating mild-to-moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women. Erythromycin is a macrolide antibiotic that has long been used as a topical dosage form to treat acne. It has favorable effects in resolving inflammatory acne lesions not only by reducing Propioni bacterium acnes density, but also by directly inhibiting neutrophil chemotactic factors and reactive oxygen species (ROS) production. Zinc, a metallic element has bacteriostatic activity against Propioni bacterium acnes. Combining zinc with antibiotic (erythromycin) can reduce antibiotic resistance and increase antibiotic absorption in-to the skin. Material and methods:  In the present study, erythromycin (2% w/v) with zinc acetate (1.2% w/v) as 'topical gel' and erythromycin (2% w/v) gel alone were evaluated for treating mild to moderate inflammatory acne vulgaris. This double-blind study was carried out on 102 patients 13-25 years of age, divided into two groups. The group A received erythromycin and group B received erythromycin with zinc acetate topical gels during 3 weeks. Acne grading and lesion counts for comedones, papules and pustules were performed during each visit zero, first, second and third weeks. Results:  Erythromycin treatment (with zinc acetate) gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.Number of lesions and severity of acne were significantly reduced at the end of 3rd week in both groups ( p  < .001).  Conclusions:  In conclusion, it can be stated that erythromycin with and without zinc acetate was clinically effective, and both formulations produced a significant reductions in acne grading as well as inflamed and noninflamed lesion counts ( p  < .000). Statistically, there was no significant difference between formulation A and B.",2020,gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.,"['mild-to-moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women', 'treating mild-to-moderate acne vulgaris', '102 patients 13-25 years of age, divided into two groups']","['Combining zinc with antibiotic (erythromycin', ""topical gel' and erythromycin"", 'zinc acetate', 'Erythromycin', 'topical erythromycin gel with and without zinc acetate', 'erythromycin', 'erythromycin with zinc acetate topical gels', 'Erythromycin treatment (with zinc acetate']","['antibiotic resistance and increase antibiotic absorption', 'Number of lesions and severity of acne', 'Acne grading and lesion counts for comedones, papules and pustules', 'number of acne lesions and severity grade of acne']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0263443', 'cui_str': 'Pustular acne (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C0149368', 'cui_str': 'Zinc Acetate'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0221228', 'cui_str': 'Comedone (disorder)'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0241157', 'cui_str': 'Pustule (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",102.0,0.0755926,gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.,"[{'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Sayyafan', 'Affiliation': 'Department of Pharmaceutics School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ramzi', 'Affiliation': 'Department of Pharmaceutics School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rahmatollah', 'Initials': 'R', 'LastName': 'Salmanpour', 'Affiliation': 'Department of Dermatology School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1606394']
675,31008867,Thromboelastography-guided Blood Product Transfusion in Cirrhosis Patients With Variceal Bleeding: A Randomized Controlled Trial.,"GOALS


The aim of this study was to assess the use of thromboelastography (TEG)-directed blood product transfusion in cirrhotic patients with acute variceal bleeding compared with conventional transfusion for correction of coagulopathy.
BACKGROUND


Coagulopathy is common in patients with cirrhosis. Recommendations for correction of conventional parameters of coagulation-platelets and the international normalized ratio before endoscopy in patients with acute variceal bleeding-need more validation.
STUDY


In this randomized controlled trial, cirrhotic patients with severe coagulopathy and acute variceal bleeding were randomized to either TEG-guided blood product transfusion or conventional transfusion from March 2017 to December 2017. The primary outcome was the difference in the amount of fresh frozen plasma and platelet units transfused between the groups. Secondary outcomes were rebleeding at 5 days and 42 days, and 6-week mortality.
RESULTS


Of the 60 recruited patients, 30 each were randomized to the TEG and conventional transfusion groups. There were no differences in baseline characteristic and endoscopic findings between the 2 groups. Four subjects in the TEG group received blood product transfusions versus all in the conventional transfusion group (13.3% vs. 100%; P<0.001). The control of bleeding on initial endoscopy was similar in the 2 groups. Rebleeding in the TEG and conventional transfusion groups at 5 days was similar [1 (3.3%) vs. 4 (13.3%), P=0.167], whereas it was significantly less in the TEG group at 42 days [3 (10%) vs. 11 (36.7%), P=0.012]. Mortality at 6 weeks was seen in 4 (13.3%) in the TEG group and in 8 (26.7%) patients in the conventional transfusion group (P=0.176).
CONCLUSIONS


TEG-guided strategy was associated with reduced blood product transfusion to correct coagulopathy without compromising hemostasis in cirrhotic patients (Clinical trial ID: CTRI/2017/02/007864).",2020,"CONCLUSIONS


TEG-guided strategy was associated with reduced blood product transfusion to correct coagulopathy without compromising hemostasis in cirrhotic patients (Clinical trial ID: CTRI/2017/02/007864).","['cirrhotic patients with severe coagulopathy and acute variceal bleeding', 'cirrhotic patients with acute variceal bleeding compared with conventional transfusion for correction of coagulopathy', 'Cirrhosis Patients', 'patients with acute variceal bleeding-need more validation', '60 recruited patients', 'patients with cirrhosis']","['thromboelastography (TEG)-directed blood product transfusion', 'TEG-guided blood product transfusion or conventional transfusion', 'TEG', 'Thromboelastography-guided Blood Product Transfusion']","['Mortality', 'control of bleeding on initial endoscopy', 'Rebleeding', 'blood product transfusions', 'amount of fresh frozen plasma and platelet units transfused', 'baseline characteristic and endoscopic findings', 'rebleeding at 5 days and 42 days, and 6-week mortality']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",60.0,0.0898919,"CONCLUSIONS


TEG-guided strategy was associated with reduced blood product transfusion to correct coagulopathy without compromising hemostasis in cirrhotic patients (Clinical trial ID: CTRI/2017/02/007864).","[{'ForeName': 'Gyanranjan', 'Initials': 'G', 'LastName': 'Rout', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shalimar', 'Affiliation': ''}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gunjan', 'Affiliation': ''}, {'ForeName': 'Soumya J', 'Initials': 'SJ', 'LastName': 'Mahapatra', 'Affiliation': ''}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Kedia', 'Affiliation': ''}, {'ForeName': 'Pramod K', 'Initials': 'PK', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Baibaswata', 'Initials': 'B', 'LastName': 'Nayak', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001214']
676,31669446,Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study.,"BACKGROUND


Child mental health problems continue to be a major global concern, especially in low- and middle-income countries (LMICs). Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs. However, there remain substantial barriers to scaling up evidence-based interventions due to limited human and financial resources in such countries.
METHODS


This protocol is for a multi-center cluster randomized factorial trial of an evidence-based parenting intervention, Parenting for Lifelong Health for Young Children, for families with children ages 2-9 years with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition). The trial will test three intervention components: length (5 vs. 10 sessions), engagement (basic vs. enhanced package), and fidelity (on-demand vs. structured supervision). Primary outcomes are child aggressive behavior, dysfunctional parenting, and positive parenting. Analyses will examine the main effect and cost-effectiveness of each component, as well as potential interaction effects between components, in order to identify the most optimal combination of program components.
DISCUSSION


This study is the first factorial experiment of a parenting program in LMICs. Findings will inform the subsequent testing of the optimized program in a multisite randomized controlled trial in 2021.
TRIAL REGISTRATION


NCT03865485 registered in ClinicalTrials.gov on March 5, 2019.",2019,"Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs.","['Young Children, for families with children ages 2-9\u202fyears with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition', 'Southeastern Europe (RISE']","['evidence-based parenting intervention, Parenting for Lifelong Health', 'parenting interventions']","['child aggressive behavior, dysfunctional parenting, and positive parenting']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0026374', 'cui_str': 'Moldavian S.S.R.'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",864.0,0.254556,"Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Brühl', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Taut', 'Affiliation': 'Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Margiad Elen', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Raleva', 'Affiliation': 'Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, North Macedonia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Båban', 'Affiliation': 'Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Lesco', 'Affiliation': 'Health for Youth Association, Chișinău, Republic of Moldova.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Foran', 'Affiliation': 'Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105855']
677,30998547,Understanding Variability in Individual Response to Hearing Aid Signal Processing in Wearable Hearing Aids.,"OBJECTIVES


Previous work has suggested that individual characteristics, including amount of hearing loss, age, and working memory ability, may affect response to hearing aid signal processing. The present study aims to extend work using metrics to quantify cumulative signal modifications under simulated conditions to real hearing aids worn in everyday listening environments. Specifically, the goal was to determine whether individual factors such as working memory, age, and degree of hearing loss play a role in explaining how listeners respond to signal modifications caused by signal processing in real hearing aids, worn in the listener's everyday environment, over a period of time.
DESIGN


Participants were older adults (age range 54-90 years) with symmetrical mild-to-moderate sensorineural hearing loss. We contrasted two distinct hearing aid fittings: one designated as mild signal processing and one as strong signal processing. Forty-nine older adults were enrolled in the study and 35 participants had valid outcome data for both hearing aid fittings. The difference between the two settings related to the wide dynamic range compression and frequency compression features. Order of fittings was randomly assigned for each participant. Each fitting was worn in the listener's everyday environments for approximately 5 weeks before outcome measurements. The trial was double blind, with neither the participant nor the tester aware of the specific fitting at the time of the outcome testing. Baseline measures included a full audiometric evaluation as well as working memory and spectral and temporal resolution. The outcome was aided speech recognition in noise.
RESULTS


The two hearing aid fittings resulted in different amounts of signal modification, with significantly less modification for the mild signal processing fitting. The effect of signal processing on speech intelligibility depended on an individual's age, working memory capacity, and degree of hearing loss. Speech recognition with the strong signal processing decreased with increasing age. Working memory interacted with signal processing, with individuals with lower working memory demonstrating low speech intelligibility in noise with both processing conditions, and individuals with higher working memory demonstrating better speech intelligibility in noise with the mild signal processing fitting. Amount of hearing loss interacted with signal processing, but the effects were small. Individual spectral and temporal resolution did not contribute significantly to the variance in the speech intelligibility score.
CONCLUSIONS


When the consequences of a specific set of hearing aid signal processing characteristics were quantified in terms of overall signal modification, there was a relationship between participant characteristics and recognition of speech at different levels of signal modification. Because the hearing aid fittings used were constrained to specific fitting parameters that represent the extremes of the signal modification that might occur in clinical fittings, future work should focus on similar relationships with more diverse types of signal processing parameters.",2019,"The two hearing aid fittings resulted in different amounts of signal modification, with significantly less modification for the mild signal processing fitting.","['everyday listening environments', 'Forty-nine older adults were enrolled in the study and 35 participants had valid outcome data for both hearing aid fittings', 'Wearable Hearing Aids', 'Participants were older adults (age range 54-90 years) with symmetrical mild-to-moderate sensorineural hearing loss']",[],"['full audiometric evaluation as well as working memory and spectral and temporal resolution', 'wide dynamic range compression and frequency compression features', 'aided speech recognition in noise', 'speech intelligibility']","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}]",[],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0428763', 'cui_str': 'Temporal resolution (observable entity)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}]",49.0,0.0245949,"The two hearing aid fittings resulted in different amounts of signal modification, with significantly less modification for the mild signal processing fitting.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Souza', 'Affiliation': 'Department of Communication Sciences and Disorders and Knowles Hearing Center, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Arehart', 'Affiliation': 'Department of Speech Language Hearing Sciences, University of Colorado at Boulder.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schoof', 'Affiliation': 'Department of Speech, Hearing and Phonetic Sciences, Division of Psychology and Language Sciences, University College London.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Department of Otolaryngology, University of Colorado School of Medicine.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Strori', 'Affiliation': 'Department of Communication Sciences and Disorders, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Balmert', 'Affiliation': 'Department of Preventive Medicine, Biostatistics Collaboration Center, Feinberg School of Medicine, Northwestern University.'}]",Ear and hearing,['10.1097/AUD.0000000000000717']
678,30985218,The effects of isotretinoin on affective and cognitive functions are disparate in adolescent acne vulgaris patients.,"Background:  The vulnerable brain regions to isotretinoin are represented as hippocampus and prefrontal cortex, involved in mood regulation as well as coordination of cognitive functions. Adolescence is a critical period with dynamic alterations in neurocognition. Isotretinoin brought concerns about its possible effects on executive functions, attention and memory. Objective:  Evaluate the impacts of isotretinoin on neurocognitive functions in adolescents with acne vulgaris and determine the emergence of psychiatric side effects. Materials and methods:  Fifty-five adolescent acne vulgaris patients were assigned to either isotretinoin ( n  = 38) or systemic antibiotic ( n  = 17) groups. The neuropsychological test battery and psychometric tests were performed before treatment and during treatment with 3-months intervals. Results:  Stroop-TBAG form, verbal-auditory digit span, controlled oral word association test and trail making test results improved in the isotretinoin treatment group along with stable scores in the antibiotic group. Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline. None of the patients was evaluated as depressive by the psychiatric examination. Conclusions:  In a vulnerable age group, our results demonstrate an improvement for neurocognitive functions in isotretinoin patients. The conflicting results suggest distinct mechanisms to be responsible for the effects on affective and cognitive functions.",2020,Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline.,"['Fifty-five', 'adolescent acne vulgaris patients', 'adolescents with acne vulgaris']","['systemic antibiotic', 'isotretinoin']","['neurocognitive functions', 'Children Depression Scale scores', 'executive functions, attention and memory', 'verbal-auditory digit span, controlled oral word association test and trail making test results', 'affective and cognitive functions']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451069', 'cui_str': 'Child depression scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",55.0,0.0196778,Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline.,"[{'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Botsali', 'Affiliation': 'School of Medicine, Department of Dermatology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Kocyigit', 'Affiliation': 'School of Medicine, Department of Dermatology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Uran', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Ankara University, Ankara, Turkey.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1606396']
679,30950493,Morbidity in a Longitudinal Cohort of Children Residing in Villages Randomized to Biannual Treatment With Azithromycin Versus Placebo.,"BACKGROUND


The mechanisms underlying the finding of reduced child mortality in communities with biannual treatment with azithromycin remain unclear. We determined if there was a difference in morbidity in a cohort of children aged 1-36 months, residing in communities randomized to biannual treatment of preschool-aged children with azithromycin or placebo.
METHODS


Thirty villages in Kilosa, Tanzania, were randomly assigned to receive biannual treatment of all children aged 1-59 months with either azithromycin (20/mg/kg single dose) or placebo. Children who were aged 1-36 months and participated in the baseline survey were enrolled in this cohort study and followed prospectively for 2 years. Children were monitored every 6 months for signs and symptoms of diarrheal disease, acute respiratory illness, and anemia. Mixed-effects models that include age, time, treatment arm, and the interaction of treatment arm and time as independent predictors were used to evaluate differences between children by treatment assignment over time.
RESULTS


There was no difference in rates of diarrhea, fever, or anemia by treatment arm at baseline and at all phases of follow-up. The decline over time in reported cough was statistically significant in the children residing in the azithromycin communities, but not in the placebo communities. Once adjusting for clustering and age, the difference in decline between the 2 treatment arms was not significant (P = .09).
CONCLUSIONS


A beneficial effect of azithromycin treatment on morbidity outcomes was not evident at biannual surveys.
CLINICAL TRIALS REGISTRATION


NCT02048007.",2020,"There was no difference in rates of diarrhea, fever, or anemia by treatment arm at baseline and at all phases of follow up.","['Children who were age 1 to 35 months and participated in the baseline survey were enrolled in this cohort study and followed prospectively for two years', 'children ages 1 to 36 months, residing in communities randomized to biannual treatment of pre-school age children with', '30 villages in Kilosa Tanzania']","['azithromycin', 'azithromycin or placebo', 'azithromycin versus placebo', 'placebo']","['morbidity outcomes', 'decline over time in reported cough', 'rates of diarrhea, fever, or anemia', 'diarrheal disease, acute respiratory illness, and anemia', 'morbidity', 'Morbidity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",,0.151418,"There was no difference in rates of diarrhea, fever, or anemia by treatment arm at baseline and at all phases of follow up.","[{'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Maryland.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Maryland.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa District, Tanzania.'}, {'ForeName': 'Mabula', 'Initials': 'M', 'LastName': 'Kasubi', 'Affiliation': 'Department of Microbiology, Muhimbili Medical Center, Dar es Salaam, Tanzania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lietman', 'Affiliation': 'Proctor Foundation, University of California, San Francisco.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Coles', 'Affiliation': 'Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, Maryland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz269']
680,31712335,Supporting Aboriginal Community Controlled Health Services to deliver alcohol care: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Indigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms. In Australia, Aboriginal Community Controlled Health Services (ACCHSs) offer culturally accessible care to Aboriginal and Torres Strait Islander (Indigenous) peoples. However there are many competing health, socioeconomic and cultural client needs.
METHODS AND ANALYSIS


A randomised cluster wait-control trial will test the effectiveness of a model of tailored and collaborative support for ACCHSs in increasing use of alcohol screening (with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)) and of treatment provision (brief intervention, counselling or relapse prevention medicines).
SETTING


Twenty-two ACCHSs across Australia.
RANDOMISATION


Services will be stratified by remoteness, then randomised into two groups. Half receive support soon after the trial starts (intervention or 'early support'); half receive support 2 years later (wait-control or 'late support').
THE SUPPORT


Core support elements will be tailored to local needs and include: support to nominate two staff as champions for increasing alcohol care; a national training workshop and bimonthly teleconferences for service champions to share knowledge; onsite training, and bimonthly feedback on routinely collected data on screening and treatment provision.
OUTCOMES AND ANALYSIS


Primary outcome is use of screening using AUDIT-C as routinely recorded on practice software. Secondary outcomes are recording of brief intervention, counselling, relapse prevention medicines; and blood pressure, gamma glutamyltransferase and HbA1c. Multi-level logistic regression will be used to test the effectiveness of support.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from eight ethics committees: the Aboriginal Health and Medical Research Council of New South Wales (1217/16); Central Australian Human Research Ethics Committee (CA-17-2842); Northern Territory Department of Health and Menzies School of Health Research (2017-2737); Central Queensland Hospital and Health Service (17/QCQ/9); Far North Queensland (17/QCH/45-1143); Aboriginal Health Research Ethics Committee, South Australia (04-16-694); St Vincent's Hospital (Melbourne) Human Research Ethics Committee (LRR 036/17); and Western Australian Aboriginal Health Ethics Committee (779).
TRIAL REGISTRATION NUMBER


ACTRN12618001892202; Pre-results.",2019,"INTRODUCTION


Indigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms.",['Twenty-two ACCHSs across Australia'],[],"['use of screening using AUDIT-C as routinely recorded on practice software', 'recording of brief intervention, counselling, relapse prevention medicines; and blood pressure, gamma glutamyltransferase and HbA1c']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",,0.100966,"INTRODUCTION


Indigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms.","[{'ForeName': 'Kristie H', 'Initials': 'KH', 'LastName': 'Harrison', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, 2006.'}, {'ForeName': 'Ks Kylie', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Discpline of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Discpline of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Hayman', 'Affiliation': 'Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Inala, Queensland, Australia.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Ivers', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW, 2006.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Haber', 'Affiliation': 'Discpline of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Conigrave', 'Affiliation': 'Discpline of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Aboriginal Health Council of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Hummerston', 'Affiliation': 'Aboriginal Health Council of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gray', 'Affiliation': 'National Drug Research Institute, Curtin University Bentley Campus, Perth, Western Australia, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Conigrave', 'Affiliation': 'Discpline of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia kate.conigrave@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-030909']
681,31710801,"Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study.","BACKGROUND/AIMS


We aimed to assess the role of vitamin D supplementation in the response to pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV) treatment in patients with chronic hepatitis C (CHC).
METHODS


Our study was a multi-center, randomized controlled trial in 11 hospitals. CHC patients were randomly assigned (1:1) to two groups namely, PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group). The primary end-point was the rate of sustained virologic response (SVR).
RESULTS


One hundred forty eight CHC patients were randomly assigned to two groups. Seventy-one patients received the PEG-IFN-α plus RBV and 77 patients received the PEG-IFN-α plus RBV + vitamin D. A total of 105 patients completed the study (control group, 47 vs. vitamin D group, 58). Baseline characteristics were mostly similar in both the groups. There was a modest but non-significant increase in SVR in the vitamin D group compared to the control group with the intention to treat analysis (64.0% vs. 49.3 %, p = 0.071) as well as in the per protocol analysis (control group vs. vitamin D group: 74.5% vs. 84.5%, p = 0.202). Fifty-two patients (73.2%) in the control group and 63 patients (81.8%) in the vitamin D group experienced at least one adverse event. The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
CONCLUSION


Vitamin D supplement did not increase SVR in treatment naïve patients with CHC irrespective of genotype.",2020,"The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
","['patients with chronic hepatitis C (CHC', 'CHC patients', 'One hundred forty eight CHC patients', '11 hospitals', '105 patients completed the study (control group, 47 vs. vitamin D group, 58', 'patients with chronic hepatitis C']","['PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group', 'pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV', 'vitamin D supplementation', 'PEG-IFN-α plus RBV', 'PEG-IFN-α plus RBV + vitamin D', 'Vitamin D supplement', 'vitamin D', 'vitamin D supplements']","['SVR', 'rate of sustained virologic response (SVR', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",148.0,0.118806,"The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
","[{'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Sol Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Sang Gyune', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Se Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.'}, {'ForeName': 'Soung Won', 'Initials': 'SW', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae-Jun', 'Initials': 'JJ', 'LastName': 'Shim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyoung Su', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Suk', 'Affiliation': 'Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Sang Bong', 'Initials': 'SB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.273']
682,30949742,The effectiveness of preoperative colon cleansing on post-operative surgical site infection after hip hemiarthroplasty.,"AIM


This study aimed to evaluate the effectiveness of prophylactic mechanical bowel preparation in elderly patients undergoing hip hemiarthroplasty in a single training institution over a period of 2 years.
PATIENTS AND METHODS


The study was conducted in a prospective-randomised manner. All patients, who underwent primary hip hemiarthroplasty for femoral neck fracture in our institution between 20 February 2015 and 29 December 2016, were included. B.T. Enema (sodium dihydrogen phosphate + disodium hydrogen phosphate) 135 ml (Yenisehir Laboratory, Ankara, Turkey) was used for colon cleansing.
RESULTS


Ninety-five patients were followed up for at least 1 year after surgery (16.3 ± 4.2 months). Of these, 46 were in the enema group and 49 were in the control group. Demographic and clinical characteristics of patients were similar in both groups (p > 0.05). Infection rates between the two groups were not significantly different (p > 0.05). In addition, ASA, age, sex, presence of diabetes mellitus, duration of surgery, time to surgery, ambulation status and blood count did not have a significant effect on surgical site infections (p > 0.05). However, all infections in the enema group were monobacterial and were successfully treated, whereas two of the four infections in the control group were polymicrobial and could not be successfully treated.
CONCLUSION


Although preoperative colon cleansing did not reduce the overall incidence of post-operative infections, our study suggested that it may reduce polymicrobial infections after hip hemiarthroplasty. Polymicrobial infections after hip hemiarthroplasty seem to have worse prognosis. Therefore, the effectiveness of preoperative colon cleansing in remediating such infections must be investigated in a larger number of patients.",2020,Infection rates between the two groups were not significantly different (p > 0.05).,"['All patients, who underwent primary hip hemiarthroplasty for femoral neck fracture in our institution between 20 February 2015 and 29 December 2016, were included', 'post-operative surgical site infection after hip hemiarthroplasty', 'elderly patients undergoing hip hemiarthroplasty in a single training institution over a period of 2\xa0years']","['prophylactic mechanical bowel preparation', 'preoperative colon cleansing', 'B.T. Enema (sodium dihydrogen phosphate\u2009+\u2009disodium hydrogen phosphate']","['polymicrobial infections', 'surgical site infections', 'Infection rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0014268', 'cui_str': 'Enematas'}, {'cui': 'C0770578', 'cui_str': 'Sodium Phosphate, Monobasic'}, {'cui': 'C0982396', 'cui_str': 'SODIUM PHOSPHATE, DIBASIC, ANHYDROUS'}]","[{'cui': 'C0275524', 'cui_str': 'Co-infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",95.0,0.0327609,Infection rates between the two groups were not significantly different (p > 0.05).,"[{'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batibay', 'Affiliation': 'Derince Education and Research Hospital, Department of Orthopedics and Trauma, SB University, Kocaeli, Turkey. sefabatibay@hotmail.com.'}, {'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Soylemez', 'Affiliation': 'Istanbul Fatih Sultan Mehmet Education and Research Hospital, Department of Orthopaedics and Trauma, SB University, Istanbul, Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Türkmen', 'Affiliation': 'Umraniye Education and Research Hospital, Department of Orthopedics and Trauma, SB University, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bayram', 'Affiliation': 'Umraniye Education and Research Hospital, Department of Orthopedics and Trauma, SB University, Istanbul, Turkey.'}, {'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Camur', 'Affiliation': 'Umraniye Education and Research Hospital, Department of Orthopedics and Trauma, SB University, Istanbul, Turkey.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-019-01125-1']
683,30977717,Spiritual Care at the End of Life: Does Educational Intervention Focused on a Broad Definition of Spirituality Increase Utilization of Chaplain Spiritual Support in Hospice?,"Background:  Research shows that religion and spirituality are important when persons cope with serious and life-threatening illness. Patients who receive good spiritual care report greater quality of life and better coping, and such support is strongly associated with greater well-being, hope, optimism, and reduction of despair at end of life. Despite these benefits, evidence shows that many patients and caregivers (P/C) refuse spiritual care when a hospice team offers it, possibly resulting in unnecessary suffering.  Objective:  To better understand what contributes to spiritual support acceptance in hospice care.  Design:  Quasi-experimental quantitative study.  Setting/Subjects:  200 patients admitted to hospice.  Measurements:  Participants were divided equally into intervention and control arms. Control participants received standard information about the availability of chaplain support and an offer for referral to chaplain services. Intervention participants received educational intervention that explained hospice chaplain services and the evidence-based benefits of spiritual support. The association of chaplain acceptance was measured with treatment group, patient age, disease, church affiliation and support, sex, bereavement risk, and place of residence.  Results:  Among intervention participants, 64 (64%) accepted spiritual support versus 52 (52%) of control participants. The intervention arm's acceptance rate was higher than the control arm after adjustment for other variables. The variables associated with acceptance were age, primary diagnosis, and place of residence.  Conclusions:  This research suggests that educational intervention that explains spiritual care in hospice and its benefits contributes importantly to greater acceptance and allows P/C to gain the benefits of spiritual support during end-of-life care.",2019,"Among intervention participants, 64 (64%) accepted spiritual support versus 52 (52%) of control participants.","['Spiritual Care at the End of Life', '200 patients admitted to hospice']","['educational intervention', 'educational intervention that explained hospice chaplain services and the evidence-based benefits of spiritual support']","['chaplain acceptance', 'acceptance rate', 'quality of life and better coping']","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}]","[{'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0558269', 'cui_str': 'Chaplain'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150355', 'cui_str': 'Spiritual support'}]","[{'cui': 'C0558269', 'cui_str': 'Chaplain'}, {'cui': 'C0034380'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",200.0,0.040451,"Among intervention participants, 64 (64%) accepted spiritual support versus 52 (52%) of control participants.","[{'ForeName': 'Jacek T', 'Initials': 'JT', 'LastName': 'Soroka', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Collins', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Creech', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Kutcher', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Menne', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}, {'ForeName': 'Brianna L', 'Initials': 'BL', 'LastName': 'Petzel', 'Affiliation': '1Mayo Clinic Health System Hospice, Mankato, Minnesota.'}]",Journal of palliative medicine,['10.1089/jpm.2018.0579']
684,30846465,Analysis of the MILES cohort reveals determinants of disease progression and treatment response in lymphangioleiomyomatosis.,"INTRODUCTION


The Multicenter International Lymphangioleiomyomatosis (LAM) Efficacy of Sirolimus (MILES) trial revealed that sirolimus stabilised lung function in patients with moderately severe LAM. The purpose of this study was to further examine the MILES cohort for the effects of racial, demographic, clinical and physiological patient characteristics on disease progression and treatment response in LAM.
METHODS


MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian), bronchodilator responsiveness (present/absent), initial forced expiratory volume in 1 s (FEV 1 ; 51-70%  versus  ≤50% predicted) and tuberous sclerosis complex (TSC) association (yes/no). A linear mixed effects model was used to compare slope differences, and nonparametric tests were used to compare medians and proportions between treatment groups in each stratum.
RESULTS


In the MILES placebo group, pre-menopausal patients declined 5-fold faster than post-menopausal patients (mean±se FEV 1  slope -17±3  versus  -3±3 mL·month -1 ; p=0.003). Upon treatment with sirolimus, both the pre-menopausal (-17±3  versus  -1±2 mL·month -1 ; p<0.0001) and post-menopausal patients (-3±3  versus  6±3 mL·month -1 ; p=0.04) exhibited a beneficial response in mean±se FEV 1  slope compared with the placebo group. Race, LAM subtype, bronchodilator responsiveness or baseline FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group. Menopausal status and race had differential effects on the adverse event profile of sirolimus. Baseline serum vascular endothelial growth factor (VEGF)-D >600 pg·mL -1  identified subgroups of patients who were more likely to decline on placebo and respond to treatment with sirolimus.
CONCLUSIONS


In LAM patients, treatment with sirolimus is beneficial regardless of menopausal status, race, bronchodilator responsiveness, baseline FEV 1  or TSC association. Serum VEGF-D and menopausal status can help inform therapeutic decisions.",2019,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"['patients with moderately severe LAM', 'MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian']","['sirolimus', 'MILES placebo', 'placebo', 'Sirolimus (MILES', 'Lymphangioleiomyomatosis (LAM']","['rate of disease progression', 'Baseline serum vascular endothelial growth factor (VEGF)-D ', 'Serum VEGF-D and menopausal status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0751674', 'cui_str': 'Lymphangioleiomyomatosis'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.156081,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"[{'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Hye-Seung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Young', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lianne G', 'Initials': 'LG', 'LastName': 'Singer', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Barker', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Chapman', 'Affiliation': 'Cleveland Clinic, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Brantly', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stocks', 'Affiliation': 'University of Texas Health Sciences Center, Tyler, TX, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Lynch', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Downey', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'Taveira-DaSilva', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Setchell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'McCormack', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02066-2018']
685,31707815,"Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions.","BACKGROUND


Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.
METHODS


This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.
RESULTS


In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.
CONCLUSIONS


This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.",2019,"Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years).",['migraine'],"['erenumab, a novel calcitonin gene-related peptide receptor antagonist', 'placebo', 'erenumab']","['constipation', 'adverse events', 'exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies', 'Exposure-adjusted adverse event rates', 'muscle spasm', 'rates of injection site reactions, constipation, and muscle spasm']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4704728', 'cui_str': 'CGRP Receptor Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",,0.665144,"Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years).","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolezil', 'Affiliation': 'Dado Medical sro, Prague Headache Center, Prague, Czech Republic.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Yanchen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888222']
686,30271727,Social determinants of tuberculosis evaluation among household contacts: a secondary analysis.,"Setting:  Seven public sector tuberculosis (TB) units and surrounding communities in Kampala, Uganda.  Objective:  To evaluate the influence of household-level socio-economic characteristics on completion of TB evaluation during household contact investigation.  Design:  A cross-sectional study nested within the control arm of a randomized, controlled trial evaluating home-based sputum collection and short messaging service communications. We used generalized estimating equations to estimate the association between completion of TB evaluation and socio-economic determinants.  Results:  Of 116 household contacts referred to clinics for TB evaluation, 32 (28%) completed evaluation. Completing evaluation was strongly clustered by household. Controlling for individual symptoms, contacts from households earning below-median income (adjusted risk ratio [aRR] 0.28, 95%CI 0.09-0.88,  P =  0.029) and contacts from households in which the head of household had no more than primary-level education (aRR 0.40, 95%CI 0.18-0.89,  P =  0.025) were significantly less likely to complete evaluation for TB.  Conclusion:  Socio-economic factors such as low income and education increase the risk that household contacts of TB patients will experience barriers to completing TB evaluation themselves. Further research is needed to identify specific mechanisms by which these underlying social determinants modify the capability and motivation of contacts to complete contact investigation.",2018,"Controlling for individual symptoms, contacts from households earning below-median income (adjusted risk ratio [aRR] 0.28, 95%CI 0.09-0.88,  P =  0.029) and contacts from households in which the head of household had no more than primary-level education (aRR 0.40, 95%CI 0.18-0.89,  P =  0.025) were significantly less likely to complete evaluation for TB.  ","['116 household contacts referred to clinics for TB evaluation, 32 (28%) completed evaluation', 'household contacts', 'Setting:  Seven public sector tuberculosis (TB) units and surrounding communities in Kampala, Uganda']",[],[],"[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]",[],[],,0.172556,"Controlling for individual symptoms, contacts from households earning below-median income (adjusted risk ratio [aRR] 0.28, 95%CI 0.09-0.88,  P =  0.029) and contacts from households in which the head of household had no more than primary-level education (aRR 0.40, 95%CI 0.18-0.89,  P =  0.025) were significantly less likely to complete evaluation for TB.  ","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shelby', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ochom', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.'}]",Public health action,['10.5588/pha.18.0025']
687,31536809,"A religiously-tailored, multilevel intervention in African American churches to increase HIV testing: Rationale and design of the Taking It to the Pews cluster randomized trial.","HIV continues to disproportionately impact African American (AA) communities. Due to delayed HIV diagnosis, AAs tend to enter HIV treatment at advanced stages. There is great need for increased access to regular HIV testing and linkage to care services for AAs. AA faith institutions are highly influential and have potential to increase the reach of HIV testing in AA communities. However, well-controlled full-scale trials have not been conducted in the AA church context. We describe the rationale and design of a 2-arm cluster randomized trial to test a religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS]) against a standard information arm on HIV testing rates among AA church members and community members they serve. Using a community-engaged approach, TIPS intervention components are delivered by trained church leaders via existing multilevel church outlets using religiously-tailored HIV Tool Kit materials and activities (e.g., sermons, responsive readings, video/print testimonials, HIV educational games, text messages) to encourage testing. Church-based HIV testing events and linkage to care services are conducted by health agency partners. Control churches receive standard, non-tailored HIV information via multilevel church outlets. Secondarily, HIV risk/protective behaviors and process measures on feasibility, fidelity, and dose/exposure are assessed. This novel study is the first to fully test an HIV testing intervention in AA churches - a setting with great reach and influence in AA communities. It could provide a faith-community engagement model for delivering scalable, wide-reaching HIV prevention interventions by supporting AA faith leaders with religiously-appropriate HIV toolkits and health agency partners.",2019,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"['African American churches', 'AA churches - a setting with great reach and influence in AA communities']","['Control churches receive standard HIV education information', 'religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS']","['feasibility, fidelity, and dose/exposure', 'HIV testing rates']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}]",,0.0373933,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berkley-Patton', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America. Electronic address: berkleypattonj@umkc.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bowe Thompson', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City & Schools of Medicine and Pharmacy, University of Missouri-Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City & Department of Pediatrics, University of Missouri, Kansas City, MO, United States of America.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'The Institute for Community Research, Hartford, CT, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Derose', 'Affiliation': 'Pardee RAND Graduate School, RAND Corporation, Santa Monica, CA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Center for Health Communication Research, School of Public Health, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allsworth', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Simon', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105848']
688,31708636,Efficiency of vitamin D supplementation in patients with mechanical low back ache.,"Background


Preliminary evidence suggests an association of hypovitaminosis D (hypo.D) with mechanical Low back ache (mLBA).
Aim


This study was designed to 1. Explore the relationship of hypovitaminosis D with mLBA in the absence of other confounding factors 2. Formulate and validate an appropriate treatment protocol and 3. Explore the differences in outcomes with various oral formulations of vitamin D available in Indian market.
Materials & methods


Three randomised groups of patients with mLBA and hypo.D between 18 and 45 years of age without any co morbid conditions were studied for the effectiveness of adjunctive vit.D supplementation of 6,00,000 IUs (60,000 IUs/day for ten consecutive days) in the form of granule or nano syrup or soft gel capsule for the treatment of mLBA. Review evaluation of pain, functional disability and vit.D was done at three weeks and an additional evaluation of vit.D was done at nine months. Evaluation with 3,00,000 IUs of vit.D (60,000 IUs/day for five consecutive days) was done with nano syrup in a different cohort.
Results


High prevalence of hypo.D (96%) was noted in patients with mLBA. Significant improvement was noted after supplementation of vit.D. The subjects of nano syrup group have shown significantly better improvement compared to others (P < 0.000). Non obese and chronic patients have shown significantly better results than their peers. Though there was significant difference in vit.D before treatment, the difference of improvement between the genders, deficiency and insufficiency, in-door and out-door, smokers and non smoker subgroups was not significant. Seasonal variation in vit.D before and after the treatment was significant.
Conclusion


Hypovitaminosis D can be a potential causative factor for mLBA in addition to the other known causes. Proper evaluation and adjunctive vit.D supplementation can effectively break the vicious cycle of low back ache with significant improvement in serum vit.D level, effective relief of pain and significant functional improvement without any adverse effects. Improvement in vit.D was not significantly related to its initial status and obese individuals have shown significantly lesser improvement. The results with nano syrup formulation were significantly better compared to others. Formulation based dosage adjustments assume significance in view of these results.",2019,The subjects of nano syrup group have shown significantly better improvement compared to others (P < 0.000).,"['patients with mechanical low back ache', 'Non obese and chronic patients', 'Indian market', 'patients with mLBA and hypo']","['mechanical Low back ache (mLBA', 'vitamin D supplementation', 'vitamin D']","['D level, effective relief of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0488708,The subjects of nano syrup group have shown significantly better improvement compared to others (P < 0.000).,"[{'ForeName': 'Maheshwar', 'Initials': 'M', 'LastName': 'Lakkireddy', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Madhu Latha', 'Initials': 'ML', 'LastName': 'Karra', 'Affiliation': ""Department of Biochemistry, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Patnala', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Raju', 'Initials': 'R', 'LastName': 'Iyengar', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Nagesh', 'Initials': 'N', 'LastName': 'Cherukuri', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'K S Asif', 'Initials': 'KSA', 'LastName': 'Hussain', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Lalith Mohan', 'Initials': 'LM', 'LastName': 'Chodavarapu', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Koppolu Kranthi', 'Initials': 'KK', 'LastName': 'Kiran Kumar', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Sundeep Kund', 'Initials': 'SK', 'LastName': 'Aluka', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Arvind Kumar', 'Initials': 'AK', 'LastName': 'Bodla', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Raja Ramesh', 'Initials': 'RR', 'LastName': 'Badavath', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}, {'ForeName': 'Shravan Kumar', 'Initials': 'SK', 'LastName': 'Peddamadyam', 'Affiliation': ""Department of Orthopaedics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India.""}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.06.018']
689,30427829,"First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1.","BACKGROUND


Live, attenuated viral vectors that express HIV-1 antigens are being investigated as an approach to generating durable immune responses against HIV-1 in humans. We recently developed a replication-competent, highly attenuated Ad26 vector that expresses mosaic HIV-1 Env (rcAd26.MOS1.HIV-Env, ""rcAd26""). Here we present the results of a first-in-human, placebo-controlled clinical trial to test the safety, immunogenicity and mucosal shedding of rcAd26 given orally.
METHODS


Healthy adults were randomly assigned to receive a single oral dose of vaccine or placebo at 5:1 ratio in a dosage escalation of 10^8 to 10^11 rcAd26 VP (nominal doses) at University of Rochester Medical Center, Rochester, NY, USA. Participants were isolated and monitored for reactogenicity for 10 days post-vaccination, and adverse events were recorded up to day 112. Rectal and oropharyngeal secretions were evaluated for shedding of the vaccine. Humoral and cellular immune responses were measured. Household contacts were monitored for secondary vaccine transmission.
RESULTS


We enrolled 22 participants and 11 household contacts between February 7 and June 24, 2015. 18 participants received one dose of HIV-1 vaccine and 4 participants received placebo. The vaccine caused only mild to moderate adverse events. No vaccine-related SAEs were observed. No infectious rcAd26 viral particles were detected in rectal or oropharyngeal secretions from any participant. Env-specific ELISA and ELISPOT responses were undetectable. No household contacts developed vaccine-induced HIV-1 seropositivity or vaccine-associated illness.
CONCLUSIONS


The highly attenuated rcAd26.MOS1.HIV-Env vaccine was well tolerated up to 10^11 VP in healthy, HIV-1-uninfected adults, though the single dose was poorly immunogenic suggesting the replicative capacity of the vector was too attenuated. There was no evidence of shedding of infectious virus or secondary vaccine transmission following the isolation period. These data suggest the use of less attenuated viral vectors in future studies of live, oral HIV-1 vaccines.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02366013.",2018,No vaccine-related SAEs were observed.,"['We enrolled 22 participants and 11 household contacts between February 7 and June 24, 2015', 'Healthy adults', '18 participants']","['vaccine or placebo', 'HIV-1 vaccine', 'placebo', 'rcAd26 given orally']","['Env-specific ELISA and ELISPOT responses', 'adverse events', 'infectious rcAd26 viral particles', 'Rectal and oropharyngeal secretions', 'Humoral and cellular immune responses']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0920508', 'cui_str': 'ELISPOT'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}]",22.0,0.426998,No vaccine-related SAEs were observed.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Bunce', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Frances', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Lori F', 'Initials': 'LF', 'LastName': 'Maxfield', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Neubauer', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lane', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'International AIDS Vaccine Initiative, New York, New York, United States of America.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Verlinde', 'Affiliation': 'International AIDS Vaccine Initiative, New York, New York, United States of America.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lombardo', 'Affiliation': 'International AIDS Vaccine Initiative, New York, New York, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Yallop', 'Affiliation': 'Batavia Biosciences B.V., Leiden, The Netherlands.'}, {'ForeName': 'Menzo', 'Initials': 'M', 'LastName': 'Havenga', 'Affiliation': 'Batavia Biosciences B.V., Leiden, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fast', 'Affiliation': 'International AIDS Vaccine Initiative, New York, New York, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Treanor', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0205139']
690,30922083,Characterization and predictive mechanisms of experimentally induced tension-type headache.,"OBJECTIVE


Studies have shown it is possible to elicit a tension-type headache episode in 15 to 30% of healthy individuals following a tooth-clenching or stress-inducing task. Despite this, no studies have attempted to understand why some healthy individuals develop a headache episode while others do not.
METHODS


The present randomized, single-blind, controlled study recruited 60 healthy participants who participated in a 30-minute tooth-clenching task and 10 participants who participated in a control task. Before the tasks, participants had their pericranial tenderness and pain modulation profiles (wind-up ratio and conditioned pain modulation) assessed. Two hours later, pericranial tenderness and pressure pain thresholds were assessed as well as any developing temporomandibular disorders. Pain diaries were kept for 24 hours to register any developing pain or headache.
RESULTS


Participants with a decrease in pericranial tenderness after the tooth-clenching task were less likely to develop headache when compared to participants without. Pain modulation profiles could not predict who developed headache and who did not. Finally, no difference was found between groups for developing temporomandibular disorders. No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
CONCLUSIONS


In conclusion, it was shown that increased pericranial tenderness was not required to trigger an episode of tension-type headache in healthy participants. Furthermore, pain modulation profiles could not predict who developed headache and who did not. Finally, activation of descending inhibitory pathways, as assessed by decreases in pericranial tenderness, was protective against the development of headache. These findings provide new insights into the pathophysiology of experimentally-induced tension-type headache.",2019,"No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
","['60 healthy participants who participated in a 30-minute tooth-clenching task and 10 participants who participated in a control task', 'healthy participants']",[],"['pericranial tenderness and pressure pain thresholds', 'pain or headache', 'Pain diaries', 'headache', 'pericranial tenderness', 'pericranial tenderness and pain modulation profiles', 'develop headache', 'temporomandibular disorders']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0424444', 'cui_str': 'Clenching teeth (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0451366', 'cui_str': 'Pain diary (assessment scale)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]",60.0,0.0644487,"No difference in frequency of participants who developed headache was found between the tooth-clenching and the control task.
","[{'ForeName': 'Fernando Gustavo', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karina H', 'Initials': 'KH', 'LastName': 'Bendixen', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': '2 Scandinavian Center for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Flemming Winther', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': '4 Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': '1 Section of Orofacial Pain and Jaw Function, Department of Dentistry, Aarhus University, Aarhus, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419840779']
691,30907230,Cost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis.,"The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). Unadjusted mean quality-adjusted life-years (QALYs; 95% confidence interval [CI]) at 6 months were 0.027 (0.020-0.034;  p  < 0.001) higher in the EPO group, with an adjusted QALY increment of 0.014 (0.000-0.028;  p  = 0.04). Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144;  p  = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693;  p  = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.",2019,"Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144;  p  = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693;  p  = 0.64).","['Traumatic Brain Injury', ""patients with moderate or severe TBI from the healthcare payers' perspective"", 'patients with traumatic brain injury (TBI']","['EPO', 'Erythropoietin', 'placebo', 'erythropoietin (EPO']","['baseline IMPACT-TBI score and regional heterogeneity', 'Mean unadjusted costs', 'Unadjusted mean quality-adjusted life-years (QALYs']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2348942', 'cui_str': 'Healthcare payer'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.182648,"Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144;  p  = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693;  p  = 0.64).","[{'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Knott', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'French', 'Affiliation': 'Western Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Haddad', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Presneill', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duranteau', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de Bicêtre, Assistance Publique des Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huet', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mak', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Vallance', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Varma', 'Affiliation': 'The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Wills', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6229']
692,30890001,Effect of withholding feeds on transfusion-related acute gut injury in preterm infants: a pilot randomized controlled trial.,"Background:  Several retrospective studies have reported an increase in necrotizing enterocolitis (NEC) during the 48 h following red blood cell (RBC) transfusion. Whether withholding enteral feeding during transfusion decreases the risk of transfusion-associated acute gut injury (TRAGI) in preterm infants is unclear. Study design and methods:  In this pilot study, 112 preterm infants with gestational age ≤32 weeks and/or birth weight ≤1500 g were randomly assigned to withholding (NPO) or continuance of feeding (FED) during RBC transfusion. Primary outcome measure was development of NEC (stage ≥ 2) within 72 h of a transfusion and the change in abdominal circumference. Results:  One hundred fifty-four transfusion episodes (74 NPO and 80 FED) were analyzed. Demographic characteristics were found to be similar in both groups. There was no difference in rates of NEC (0 versus 3.4%;  p  = .49) between the NPO and FED groups. The incidence of feeding intolerance was higher in the FED group; however, it was statistically insignificant (1.9 versus 6.8%,  p  = .36). Abdominal circumference remained similar in both groups in all three consecutive days following transfusion ( p >.05). Conclusion:  This pilot study does not support withholding feedings during transfusion but is not adequately powered to test the hypothesis that NPO decreases NEC rates. Adequately powered well-designed multicenter trials are still required.",2020,There was no difference in rates of NEC (0 versus 3.4%; p = .49) between the NPO and FED groups.,"['preterm infants', 'One hundred fifty-four transfusion episodes (74 NPO and 80 FED', '112 preterm infants with gestational age ≤32\xa0weeks', 'and/or birth weight ≤1500']","['withholding (NPO) or continuance of feeding (FED', 'withholding feeds']","['development of NEC (stage ≥ 2) within 72\u2009h of a transfusion and the change in abdominal circumference', 'necrotizing enterocolitis (NEC', 'Abdominal circumference', 'incidence of feeding intolerance', 'rates of NEC']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]",112.0,0.312868,There was no difference in rates of NEC (0 versus 3.4%; p = .49) between the NPO and FED groups.,"[{'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Sahin', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gozde Kanmaz Kutman', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Yavanoglu Atay', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Emre Canpolat', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uras', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suna Oguz', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': ""Davis Children's Hospital, University of California, Sacramento, CA, USA.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1597844']
693,30794084,Low-Dose Testosterone and Evoked Resistance Exercise after Spinal Cord Injury on Cardio-Metabolic Risk Factors: An Open-Label Randomized Clinical Trial.,"The purpose of the work is to investigate the effects of low-dose testosterone replacement therapy (TRT) and evoked resistance training (RT) on body composition and metabolic variables after spinal cord injury (SCI). Twenty-two individuals with chronic motor complete SCI (ages 18-50 years) were randomly assigned to either TRT+RT ( n  = 11) or TRT ( n  = 11) for 16 weeks following a 4 -week delayed entry period. TRT+RT men underwent twice weekly progressive RT using electrical stimulation with ankle weights. TRT was administered via testosterone patches (2-6 mg/day). Body composition was tested using anthropometrics, dual energy x-ray absorptiometry, and magnetic resonance imaging. After an overnight fast, basal metabolic rate (BMR), lipid panel, serum testosterone, adiponectin, inflammatory and anabolic biomarkers (insulin-like growth factor-1 and insulin-like growth factor-binding protein 3 [IGFBP-3]), glucose effectiveness (Sg), and insulin sensitivity (Si) were measured. Total body lean mass (LM; 2.7 kg,  p  < 0.0001), whole muscle ( p  < 0.0001), and whole muscle knee extensor cross-sectional areas (CSAs;  p  < 0.0001) increased in the TRT+RT group, with no changes in the TRT group. Visceral adiposity decreased ( p  = 0.049) in the TRT group, with a trend in the TRT+RT ( p  = 0.07) group. There was a trend ( p  = 0.050) of a 14-17% increase in BMR following TRT+RT. Sg showed a trend ( p  = 0.07) to improvement by 28.5-31.5% following both interventions. IGFBP-3 increased ( p  = 0.0001) while IL-6 decreased ( p  = 0.039) following both interventions, and TRT+RT suppressed adiponectin ( p  = 0.024). TRT+RT resulted in an increase in LM and whole thigh and knee extensor muscle CSAs, with an increase in BMR and suppressed adiponectin. Low-dose TRT may mediate modest effects on visceral adipose tissue, Sg, IGFBP-3, and IL-6, independent of changes in LM.",2019,"IGFBP-3 increased (p = 0.0001) while IL-6 decreased (p = 0.039) following both interventions, and TRT+RT suppressed adiponectin (p = 0.024).","['after Spinal Cord Injury on Cardio-Metabolic Risk Factors', 'Twenty-two individuals with chronic motor complete SCI (ages 18-50 years', 'after spinal cord injury (SCI']","['TRT', 'TRT+RT', 'low-dose testosterone replacement therapy (TRT) and evoked resistance training (RT', 'Low-Dose Testosterone and Evoked Resistance Exercise', 'TRT was administered via testosterone patches']","['Body composition', 'whole muscle knee extensor cross-sectional areas', 'basal metabolic rate (BMR), lipid panel, serum testosterone, adiponectin, inflammatory and anabolic biomarkers (insulin-like growth factor-1 and insulin-like growth factor-binding protein 3 [IGFBP-3]), glucose effectiveness (Sg), and insulin sensitivity (Si', 'visceral adipose tissue, Sg, IGFBP-3, and IL-6', 'TRT+RT suppressed adiponectin', 'body composition and metabolic variables', 'BMR and suppressed adiponectin', 'IL-6', 'IGFBP-3', 'Total body lean mass', 'BMR', 'LM and whole thigh and knee extensor muscle CSAs', 'Visceral adiposity']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",22.0,0.0758576,"IGFBP-3 increased (p = 0.0001) while IL-6 decreased (p = 0.039) following both interventions, and TRT+RT suppressed adiponectin (p = 0.024).","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Ranjodh', 'Initials': 'R', 'LastName': 'Gill', 'Affiliation': 'Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gater', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Lavis', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cardozo', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, New York.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6136']
694,30902674,Effects of Elastic Resistance Training on Functional Performance and Myokines in Older Women-A Randomized Controlled Trial.,"OBJECTIVES


To investigate the short- and long-term effects of elastic resistance training (ERT) on physical performance, inflammatory markers, and myokines in older women living in a nursing home.
DESIGN


A randomized controlled trial, with 12 weeks of ERT intervention.
SETTING AND PARTICIPANTS


Nursing home. Twenty female nursing home residents (mean age = 84 ± 8 years) were randomized into 2 groups: the training group (n = 11), and the control group (n = 9).
MEASURES


Muscle mass was estimated with bioelectrical impedance, and the functional test Short Physical Performance Battery (SPPB) was performed, whereas handgrip strength and plasma concentration of myokines and inflammatory markers were measured before and after the intervention period. Additional blood samples were also taken after the fourth ERT session. A mixed model (group × time) analysis of variance was applied to determine the effect on primary and secondary outcomes.
RESULTS


After 1 exercise session, the training group showed a significant increase in brain-derived neurotrophic factor (BDNF) (P = .04) and a decrease in interleukin (IL)-8 (P = .01) plasma concentration. After 12 weeks of intervention, the results showed a significant group × time effects for the SPPB total score (P < .01), as well as gait speed (P = .04), chair rise (P < .01), and BDNF concentration (P = .02). However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
CONCLUSIONS/IMPLICATIONS


The present study emphasizes the clinical impact of moderate-intensity ERT on mobility and functional performance in older women. The results indicate that an increase in exercise-induced peripheral BDNF may have a protective role in the preservation of muscular function in older women. Incorporating ERT into nursing homes could be a feasible preventive strategy to counteract functional deterioration.",2019,"However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
","['Twenty female nursing home residents (mean age\xa0=\xa084 ± 8\xa0years', 'Nursing home', 'Older Women', 'older women', 'older women living in a nursing home']","['ERT intervention', 'Elastic Resistance Training', 'elastic resistance training (ERT']","['SPPB total score', 'mobility and functional performance', 'handgrip strength and plasma concentration of myokines and inflammatory markers', 'BDNF concentration', 'Functional Performance and Myokines', 'physical performance, inflammatory markers, and myokines', 'gait speed', 'grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein', 'functional test Short Physical Performance Battery (SPPB', 'brain-derived neurotrophic factor (BDNF', 'interleukin (IL)-8', 'chair rise']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C3853978'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C2607857'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0254610', 'cui_str': 'IL15'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",20.0,0.0611107,"However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
","[{'ForeName': 'Felicita', 'Initials': 'F', 'LastName': 'Urzi', 'Affiliation': 'University of Primorska, Faculty of Mathematics, Natural Sciences and Information Technologies, Koper, Slovenia. Electronic address: felicita.urzi@upr.si.'}, {'ForeName': 'Uros', 'Initials': 'U', 'LastName': 'Marusic', 'Affiliation': 'Science and Research Centre Koper, Institute for Kinesiology Research, Koper, Slovenia.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Ličen', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Izola, Slovenia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Buzan', 'Affiliation': 'University of Primorska, Faculty of Mathematics, Natural Sciences and Information Technologies, Koper, Slovenia. Electronic address: elena.buzan@famnit.upr.si.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.151']
695,30939096,"Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","PURPOSE


The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN).
PATIENTS AND METHODS


In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m 2 ) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. The primary end point was DFS. Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS) were also analyzed. In an exploratory analysis, intrinsic subtyping by PAM50 (Prosigna) and calculation of the risk of recurrence score were performed on the nCounter analysis system on archival tissue. Genotyping was performed to investigate TIPN.
RESULTS


A total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism,  rs3012437 , associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
CONCLUSION


With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.",2019,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","['patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received', '410 patients were enrolled from October 2007 to September 2010', 'patients with grade 2 or greater TIPN (10.4', 'patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer']","['adjuvant paclitaxel and trastuzumab', 'trastuzumab', 'paclitaxel']","['distant recurrences, 7-year OS', 'Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS', '7-year RFI', '3-year disease-free survival (DFS', 'DFS', '7-year DFS', 'risk of TIPN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",410.0,0.0620248,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Dillon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Ritterhouse', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Fuhrman', 'Affiliation': 'NanoString Technologies, Seattle, WA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baltay', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': '9Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'P Kelly', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Clinic Lester and Sue Smith Breast Center, Houston, TX.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Shapira', 'Affiliation': 'Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00066']
696,30935731,Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial.,"PURPOSE


Minimally-invasive repair of pectus excavatum by the Nuss procedure is associated with significant postoperative pain, prolonged hospital stay, and high opiate requirement. We hypothesized that intercostal nerve cryoablation during the Nuss procedure reduces hospital length of stay (LOS) compared to thoracic epidural analgesia.
DESIGN


This randomized clinical trial evaluated 20 consecutive patients undergoing the Nuss procedure for pectus excavatum between May 2016 and March 2018. Patients were randomized evenly via closed-envelope method to receive either cryoanalgesia or thoracic epidural analgesia. Patients and physicians were blinded to study arm until immediately preoperatively.
SETTING


Single institution, UCSF-Benioff Children's Hospital.
PARTICIPANTS


20 consecutive patients were recruited from those scheduled for the Nuss procedure. Exclusion criteria were age < 13 years, chest wall anomaly other than pectus excavatum, previous repair or other thoracic surgery, and chronic use of pain medications.
MAIN OUTCOMES AND MEASURES


Primary outcome was postoperative LOS. Secondary outcomes included total operative time, total/daily opioid requirement, inpatient/outpatient pain score, and complications. Primary outcome data were analyzed by the Mann-Whitney U-test for nonparametric continuous variables. Other continuous variables were analyzed by two-tailed t-test, while categorical data were compared via Chi-squared test, with alpha = 0.05 for significance.
RESULTS


20 patients were randomized to receive either cryoablation (n = 10) or thoracic epidural (n = 10). Mean operating room time was 46.5 min longer in the cryoanalgesia group (p = 0.0001). Median LOS decreased by 2 days in patients undergoing cryoablation, to 3 days from 5 days (Mann-Whitney U, p = 0.0001). Cryoablation patients required significantly less inpatient opioid analgesia with a mean decrease of 416 mg oral morphine equivalent per patient (p = 0.0001), requiring 52%-82% fewer milligrams on postoperative days 1-3 (p < 0.01 each day). There was no difference in mean pain score between the groups at any point postoperatively, up to one year, and no increased incidence of neuropathic pain in the cryoablation group. No complications were noted in the cryoablation group; among patients with epidurals, one patient experienced a symptomatic pneumothorax and another had urinary retention.
CONCLUSIONS AND RELEVANCE


Intercostal nerve cryoablation during the Nuss procedure decreases hospital length of stay and opiate requirement versus thoracic epidural analgesia, while offering equivalent pain control.
TYPE OF STUDY


Treatment study.
LEVEL OF EVIDENCE


Level I.",2019,"Cryoablation patients required significantly less inpatient opioid analgesia with a mean decrease of 416 mg oral morphine equivalent per patient (p = 0.0001), requiring 52%-82% fewer milligrams on postoperative days 1-3 (p < 0.01 each day).","['20 consecutive patients were recruited from those scheduled for the Nuss procedure', ""Single institution, UCSF-Benioff Children's Hospital"", '20 consecutive patients undergoing the Nuss procedure for pectus excavatum between May 2016 and March 2018', 'Exclusion criteria were age\u202f<\u202f13\u202fyears, chest wall anomaly other than pectus excavatum, previous repair or other thoracic surgery, and chronic use of pain medications', '20 patients']","['cryoablation', 'thoracic epidural', 'morphine', 'Intraoperative intercostal nerve cryoablation', 'cryoanalgesia or thoracic epidural analgesia', 'intercostal nerve cryoablation']","['Median LOS', 'length of stay and opioid requirement', 'hospital length of stay and opiate requirement', 'neuropathic pain', 'mean pain score', 'symptomatic pneumothorax', 'total operative time, total/daily opioid requirement, inpatient/outpatient pain score, and complications', 'urinary retention', 'postoperative LOS', 'hospital length of stay (LOS', 'inpatient opioid analgesia', 'Mean operating room time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0016842', 'cui_str': 'Pectus Excavatum'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1285089', 'cui_str': 'Intercostal Nerves'}, {'cui': 'C0524318', 'cui_str': 'Cryoanalgesia (procedure)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.13353,"Cryoablation patients required significantly less inpatient opioid analgesia with a mean decrease of 416 mg oral morphine equivalent per patient (p = 0.0001), requiring 52%-82% fewer milligrams on postoperative days 1-3 (p < 0.01 each day).","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Graves', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Jarrett', 'Initials': 'J', 'LastName': 'Moyer', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zobel', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mora', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': ""O'Day"", 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Padilla', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco.. Electronic address: benjamin.padilla@ucsf.edu.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.02.057']
697,30852167,Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention.,"OBJECTIVES


Advance care planning (ACP) is important to ensure that nursing home (NH) residents receive care concordant with their goals. Video interventions have been developed to improve the process of ACP. Yet, little is known about which NH characteristics are associated with implementation of ACP video interventions in clinical practice. Our objective was to examine NH-level characteristics associated with the implementation of an ACP video intervention as part of the Pragmatic trial of Video Education in Nursing Homes (PROVEN) trial.
DESIGN


Cross-sectional study of NHs in PROVEN.
SETTING AND PARTICIPANTS


119 NHs randomized to receive the ACP video intervention.
MEASUREMENTS


The outcomes were the proportion of short- (<100 days) and long-stay (≥100 days) NH residents who were (1) offered to watch a video and (2) shown a video, aggregated to the NH-level, and measured using electronic forms of video offers. The association between outcomes and NH facility characteristics (eg, staffing, resident acuity) and participation in other aspects of the PROVEN trial (eg, monthly check-in calls) were estimated using multivariate linear regression models. NH characteristics were measured using data from Online Survey Certification and Reporting data, Long-term Care: Facts on Care in the US and NH Compare.
RESULTS


Offer rates were 69% [standard deviation (SD): 28] for short-stay and 56% (SD: 20) for long-stay residents. Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents. After adjusting for NH characteristics, compared to 1-star NHs, higher star-rated NHs had higher offer rates. Champions' participation in check-in calls was positively associated with both outcomes for long-stay residents.
CONCLUSIONS/IMPLICATIONS


Lower-quality NHs seem unable to integrate a novel ACP video education program into routine care processes. Ongoing support for and engagement with NH staff to champion the intervention throughout implementation is important for the success of a pragmatic trial within NHs.",2019,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,['Nursing Homes (PROVEN) trial'],"['ACP video intervention', 'Video interventions', 'Advance care planning (ACP']",['proportion of short- (<100\xa0days) and long-stay'],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",119.0,0.0703926,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,"[{'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI. Electronic address: lacey_loomer@brown.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Belanger', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI; Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI; Center of Innovation in HSR&D, Providence Veterans Administration Medical Center, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.133']
698,26684265,Intensive cycle ergometer training improves gait speed and endurance in patients with Parkinson's disease: A comparison with treadmill training.,"PURPOSE


Cycle ergometer training improves gait in the elderly, but its effect in patients with Parkinson's disease (PD) is not completely known.
METHODS


Twenty-nine PD inpatients were randomized to treadmill (n = 13, PD-T) or cycle ergometer (n = 16, PD-C) training for 3 weeks, 1 hour/day. Outcome measures were distance travelled during the 6-min walking test (6MWT), spatio-temporal variables of gait assessed by baropodometry, the Timed Up and Go (TUG) duration, the balance score through the Mini-BESTest, and the score of the Unified Parkinson's Disease Rating Scale (UPDRS).
RESULTS


Sex, age, body mass index, disease duration, Hoehn-Yahr staging, comorbidity and medication did not differ between groups. At end of training, ANCOVA showed significant improvement, of similar degree, in both groups for 6MWT, speed, step length and cadence of gait, TUG, Mini-BESTest and UPDRS.
CONCLUSIONS


This pilot study shows that cycle ergometer training improves walking parameters and reduces clinical signs of PD, as much as treadmill training does. Gait velocity is accompanied by step lengthening, making the gait pattern close to that of healthy subjects. Cycle ergometer is a valid alternative to treadmill for improving gait in short term in patients with PD.",2016,"At end of training, ANCOVA showed significant improvement, of similar degree, in both groups for 6MWT, speed, step length and cadence of gait, TUG, Mini-BESTest and UPDRS.
","['healthy subjects', 'patients with PD', 'Twenty-nine PD inpatients', ""patients with Parkinson's disease"", ""patients with Parkinson's disease (PD""]","['cycle ergometer training', 'Cycle ergometer training', 'treadmill training', 'Intensive cycle ergometer training']","[""distance travelled during the 6-min walking test (6MWT), spatio-temporal variables of gait assessed by baropodometry, the Timed Up and Go (TUG) duration, the balance score through the Mini-BESTest, and the score of the Unified Parkinson's Disease Rating Scale (UPDRS"", 'Gait velocity', 'gait speed and endurance', '6MWT, speed, step length and cadence of gait, TUG, Mini-BESTest and UPDRS', 'walking parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0163324,"At end of training, ANCOVA showed significant improvement, of similar degree, in both groups for 6MWT, speed, step length and cadence of gait, TUG, Mini-BESTest and UPDRS.
","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Arcolin', 'Affiliation': 'Posture and Movement Laboratory, Division of Physical Medicine and Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Pisano', 'Affiliation': 'Division of Neurological Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Delconte', 'Affiliation': 'Division of Neurological Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Godi', 'Affiliation': 'Posture and Movement Laboratory, Division of Physical Medicine and Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Schieppati', 'Affiliation': 'Centro Studi Attività Motorie (CSAM), Fondazione Salvatore Maugeri (IRCCS), Scientific Institute of Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mezzani', 'Affiliation': 'Division of Cardiac Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Picco', 'Affiliation': 'Division of Neurological Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Posture and Movement Laboratory, Division of Physical Medicine and Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nardone', 'Affiliation': 'Posture and Movement Laboratory, Division of Physical Medicine and Rehabilitation, Scientific Institute of Veruno (NO), Fondazione Salvatore Maugeri (IRCCS), Veruno (NO), Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-150506']
699,30880285,CRP-guided antibiotic treatment in acute exacerbations of COPD in hospital admissions.,"The role of antibiotics in acute exacerbations of chronic obstructive pulmonary disease (COPD) is controversial and a biomarker identifying patients who benefit from antibiotics is mandatory. We performed a randomised, controlled trial in patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy, in order to show a reduction in antibiotic prescription.Patients hospitalised with acute exacerbations of COPD were randomised to receive antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50 mg·L -1 ).In total, 101 patients were randomised to the CRP group and 119 to the GOLD group. Fewer patients in the CRP group were treated with antibiotics compared to the GOLD group (31.7%  versus  46.2%, p=0.028; adjusted odds ratio (OR) 0.178, 95% CI 0.077-0.411, p=0.029). The 30-day treatment failure rate was nearly equal (44.5% in the CRP group  versus  45.5% in the GOLD-group, p=0.881; adjusted OR 1.146, 95% CI 0.649-1.187, p=0.630), as was the time to next exacerbation (32 days in the CRP group  versus  28 days in the GOLD group, p=0.713; adjusted hazard ratio 0.878, 95% CI 0.649-1.187, p=0.398). Length of stay was similar in both groups (7 days in the CRP group  versus  6 days in the GOLD group, p=0.206). On day-30, no difference in symptom score, quality of life or serious adverse events was detected.Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment. In the present study, no differences in adverse events between both groups were found. Further research is needed for the generalisability of these findings.",2019,Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment.,"['acute exacerbations of COPD in hospital admissions', 'Patients hospitalised with acute exacerbations of COPD', '101 patients were randomised to the CRP group and 119 to the GOLD group', 'patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy', 'acute exacerbations of chronic obstructive pulmonary disease (COPD']","['CRP-guided antibiotic treatment', 'CRP', 'antibiotics', 'antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50']","['time to next exacerbation', 'symptom score, quality of life or serious adverse events', 'adverse events', '30-day treatment failure rate', 'Length of stay']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",101.0,0.102958,Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment.,"[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Prins', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Duijkers', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van der Valk', 'Affiliation': 'Dept of Pulmonary Diseases, Medic Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Dept of Clinical Chemistry, Haematology and Immunology, Northwest Hospital, Alkmaar, The Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Dept of Pulmonary Diseases, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tjip S', 'Initials': 'TS', 'LastName': 'van der Werf', 'Affiliation': 'University of Groningen, Dept of Pulmonary Diseases and Tuberculosis, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Dept Pulmonary Diseases, Northwest Hospital, Alkmaar, The Netherlands.'}]",The European respiratory journal,['10.1183/13993003.02014-2018']
700,30880286,Randomised controlled trial of polysomnographic titration of noninvasive ventilation.,"Noninvasive ventilation (NIV) settings determined during wakefulness may produce patient-ventilator asynchrony (PVA) during sleep, causing sleep disruption and limiting tolerance. This study investigated whether NIV titrated with polysomnography (PSG) is associated with less PVA and sleep disruption than therapy titrated during daytime alone.Treatment-naive individuals referred for NIV were randomised to control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration) groups. Primary outcomes were PVA and arousal indices on PSG at 10 weeks. Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised. Most (88.3%) had a neuromuscular disorder and respiratory muscle weakness but minor derangements in daytime arterial blood gases. PVA events were less frequent in those undergoing polysomnographic titration (median (interquartile range (IQR)): PSG 25.7 (12-68) events·h -1   versus  control 41.0 (28-182) events·h -1 ; p=0.046), but arousals were not significantly different (median (IQR): PSG 11.4 (9-19) arousals·h -1   versus  control 14.6 (11-19) arousals·h -1 ; p=0.258). Overall adherence was not different except in those with poor early adherence (<4 h·day -1 ) who increased their use after polysomnographic titration (mean difference: PSG 95 (95% CI 29-161) min·day -1   versus  control -23 (95% CI -86-39) min·day -1 ; p=0.01). Arterial carbon dioxide tension, somnolence and sleep quality improved in both groups. There were no differences in nocturnal gas exchange or overall measures of HRQoL.NIV titrated with PSG is associated with less PVA but not less sleep disruption when compared with therapy titrated during daytime alone.",2019,"Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised.",['Treatment-naive individuals referred for NIV'],"['NIV titrated with polysomnography (PSG', 'control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration', 'polysomnographic titration of noninvasive\xa0ventilation', 'Noninvasive ventilation (NIV']","['neuromuscular disorder and respiratory muscle weakness', 'adherence, gas exchange, symptoms and health-related quality of life', 'nocturnal gas exchange or overall measures', 'Overall adherence', 'Arterial carbon dioxide tension, somnolence and sleep quality', 'PVA and arousal indices on PSG', 'PVA events', 'daytime arterial blood gases']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0027868', 'cui_str': 'Neuromuscular Diseases'}, {'cui': 'C1836141', 'cui_str': 'Respiratory muscle weakness'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1269842', 'cui_str': 'Finding of arterial partial pressure of carbon dioxide'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}]",60.0,0.22368,"Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised.","[{'ForeName': 'Liam M', 'Initials': 'LM', 'LastName': 'Hannan', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rautela', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berlowitz', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sheers', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chao', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Fergal J', 'Initials': 'FJ', 'LastName': ""O'Donoghue"", 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Melbourne, Australia.'}]",The European respiratory journal,['10.1183/13993003.02118-2018']
701,16977262,Gliclazide treatment lowers serum ICAM-1 levels in poorly controlled type 2 diabetic patients.,"OBJECTIVE


To investigate the potential effect of gliclazide on serum ICAM-1 (intercellular adhesion molecule-1) and VCAM-1 (vascular cell adhesion molecule-1) levels in poorly controlled type 2 diabetic patients.
PATIENTS AND METHODS


The study included 104 patients, randomly divided into two groups. Group A comprised 53 patients (26 men) treated with gliclazide with a mean age of 67.5+/-9.9 years, a mean diabetes duration of 13.4+/-5.4 years and a mean HbA1c of 8.6+/-1.1%. Group B comprised 51 patients (25 men) treated with glibenclamide with a mean age of 66.4+/-10.9 years, a mean diabetes duration of 13.2+/-6.1 years and a mean HbA1c of 8.4+/-1.3%. A third group of 30 healthy controls (15 men) with a mean age of 63.3+/-10.4 years was also included. Serum levels of ICAM-1 and VCAM-1 were measured at the beginning of the study and after six months of treatment.
RESULTS


Pretreatment serum ICAM-1 and VCAM-1 levels did not differ between groups A and B, while they were significantly higher (P=0.0001) than in healthy controls. No significant difference in HbA1c, body mass index, blood pressure control and lipid profile between the two groups was observed after the sixth month of treatment. In group A, serum ICAM-1 levels after six months of treatment were significantly reduced from 623.12+/-61.17 ng/ml to 370.14+/-49.92 ng/ml (P=0,01), while no reduction was found in VCAM-1 levels. In group B, no reduction was found in serum ICAM-1 and VCAM-1 levels after the end of the study.
CONCLUSIONS


Our results suggest that gliclazide treatment reduces serum ICAM-1 levels in poorly controlled type 2 diabetic patients. This reduction is independent of the hypoglycaemic action of gliclazide.",2006,"In group B, no reduction was found in serum ICAM-1 and VCAM-1 levels after the end of the study.
","['51 patients (25 men) treated with', '104 patients', 'with a mean age of 66.4+/-10.9 years, a mean diabetes duration of 13.2+/-6.1 years and a mean HbA1c of 8.4+/-1.3', '30 healthy controls (15 men) with a mean age of 63.3+/-10.4 years was also included', 'poorly controlled type 2 diabetic patients', 'with a mean age of 67.5+/-9.9 years, a mean diabetes duration of 13.4+/-5.4 years and a mean HbA1c of 8.6+/-1.1', '53 patients (26 men) treated with']","['gliclazide', 'Gliclazide', 'glibenclamide']","['serum ICAM-1 levels', 'VCAM-1 levels', 'Serum levels of ICAM-1 and VCAM-1', 'serum ICAM-1 (intercellular adhesion molecule-1) and VCAM-1 (vascular cell adhesion molecule-1) levels', 'serum ICAM-1 and VCAM-1 levels', 'HbA1c, body mass index, blood pressure control and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",104.0,0.0183712,"In group B, no reduction was found in serum ICAM-1 and VCAM-1 levels after the end of the study.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Papanas', 'Affiliation': 'Second Department of Internal Medicine, Democritus University of Thrace, Alexandroupolis, Greece. papanasnikos@yahoo.gr'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tziakas', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chalikias', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Floros', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Trypsianis', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Papadopoulou', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kortsaris', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Symeonidis', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Souliou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maltezos', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hatseras', 'Affiliation': ''}]",Diabetes & metabolism,[]
702,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
703,16902384,[Quasi-experimental evaluation of a nutritional educational intervention among home support assistants for the elderly].,"BACKGROUND


The French National Program on Nutrition and Health has defined two specific objectives targeting older persons: (i) to improve their status in calcium and vitamin D and (ii) to prevent undernutrition. Home help provides support in activities of daily living, including meals, to dependent persons. The objective of our study was to evaluate the impact of a nutritional education intervention on knowledge and practices among home support assistants for the elderly.
METHODS


Three facilities providing home support in Gironde (France) selected 132 home support assistants to follow an education program and 134 controls. Nutrition training was conducted in the intervention group by a dietician during two half-day sessions in May-June 2004. A non randomized controlled trial design was used for evaluation. Nutritional knowledge (20 questions) and practice (5 questions) of home support assistants were assessed by questionnaire before (April 2004) and after (September 2004) the training period in each group. Satisfaction of the intervention group was also assessed.
RESULTS


The intervention group included 101 participants and the control group 106 persons who answered both questionnaires before and after the education program. The intervention group was significantly younger (p < 0.05), less educated (p = 0.01) and had less often participated to previous nutrition training (p < 0.001) than the control group. There was no significant difference between the two groups before intervention for their mean scores of knowledge or practices. The intervention group significantly improved its knowledge score (mean gain 2.5 points, p < 0.001) after the training period, whereas the score remained unchanged in the control group (mean gain 0.5 points, p = 0.06). The impact of the nutritional education was very significant (p < 0.0001) after adjustment for the characteristics which differed between the two groups. The practice scores did not differ significantly after intervention in multivariate analyses. Satisfaction of trained home support assistants was very high.
CONCLUSION


An education program of home support assistants for elderly persons can improve their nutritional knowledge, but this study cannot conclude that the intervention was efficient to improve the nutritional status of older persons.",2006,"The intervention group significantly improved its knowledge score (mean gain 2.5 points, p < 0.001) after the training period, whereas the score remained unchanged in the control group (mean gain 0.5 points, p = 0.06).","['older persons', 'home support assistants for the elderly', '101 participants and the control group 106 persons who answered both questionnaires before and after the education program', 'elderly persons', 'Three facilities providing home support in Gironde (France) selected 132 home support assistants to follow an education program and 134 controls']","['nutritional education intervention', 'nutritional educational intervention', 'Nutrition training']","['knowledge score', 'Satisfaction', 'mean scores of knowledge or practices']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",101.0,0.0179401,"The intervention group significantly improved its knowledge score (mean gain 2.5 points, p < 0.001) after the training period, whereas the score remained unchanged in the control group (mean gain 0.5 points, p = 0.06).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Barberger-Gateau', 'Affiliation': 'Unité INSERM U593 Epidémiologie, Santé Publique et Développement, Université Victor-Segalen-Bordeaux 2, 146, rue Léo-Saignat, 33076 Bordeaux Cedex. Pascale.Barberger-Gateau@isped.u-bordeaux2.fr'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Helmer', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ouret', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gendron', 'Affiliation': ''}]",Revue d'epidemiologie et de sante publique,[]
704,16977263,"Efficacy of short term continuous subcutaneous insulin lispro versus continuous intravenous regular insulin in poorly controlled, hospitalized, type 2 diabetic patients.","UNLABELLED


Intravenous insulin infusion (IVII) is rapidly effective in improving glycaemia in uncontrolled hospitalized diabetic patients. This significantly improves their morbidity and mortality. Intravenous insulin infusion may lead to IV infusion complications and is a heavy burden for caregivers.
AIM


The aim of our work was to compare the efficacy of IV regular insulin versus lispro Continuous Subcutaneous Insulin Infusion (CSII), in improving glycaemia in patients hospitalized for uncontrolled type 2 diabetes, the efficacy being assessed on the average blood glucose level observed.
METHODS


The study was designed as a prospective randomized study. Thirty-three type 2 diabetic patients, hospitalized for uncontrolled diabetes by their usual practitioner were included. After acceptation, patients were randomly assigned to lispro CSII (group 1, n=20) or IVII regular insulin (group 2, n=13) for 5 days. Ten capillary blood glucose/day were performed. Pre-meal blood glucose targets were 4.4-6.6 mmol/l. Mann Whitney, Wilcoxon and Fischer exact tests were used.
RESULTS


BG levels decreased significantly (-3.4+/-0.55 mmol/l in group 1 and -3.60+/-0.55 mmol/l in group 2, P<0.01) during the first 12 hours. Mean daily blood glucose at day 5 was statistically improved in both groups compared to day 1 (P<0.05 Wilcoxon) and comparable between the 2 groups. No severe hypoglycaemia was reported. No catheter complications occurred in group 1, 7 occurred in group 2.
CONCLUSION


CSII and IVII infusion were comparable in rapidly improving hyperglycaemia in uncontrolled type 2 diabetic patients. CSII, being more convenient, could be preferred in medical and surgical settings.",2006,Mean daily blood glucose at day 5 was statistically improved in both groups compared to day 1 (P<0.05 Wilcoxon) and comparable between the 2 groups.,"['poorly controlled, hospitalized, type 2 diabetic patients', 'uncontrolled hospitalized diabetic patients', 'Thirty-three type 2 diabetic patients, hospitalized for uncontrolled diabetes by their usual practitioner were included', 'patients hospitalized for uncontrolled type 2 diabetes']","['IVII regular insulin', 'Intravenous insulin infusion', 'lispro CSII', 'IV regular insulin versus lispro Continuous Subcutaneous Insulin Infusion (CSII', 'short term continuous subcutaneous insulin lispro']","['BG levels', 'morbidity and mortality', 'catheter complications', 'meal blood glucose targets', 'severe hypoglycaemia', 'Mean daily blood glucose', 'hyperglycaemia']","[{'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0274317', 'cui_str': 'Complication of catheter (disorder)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",33.0,0.0138,Mean daily blood glucose at day 5 was statistically improved in both groups compared to day 1 (P<0.05 Wilcoxon) and comparable between the 2 groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boullu-Sanchis', 'Affiliation': ""Service d'Endocrinologie, Diabétologie, Maladies Métaboliques, CHRU Strasbourg, 1, Place de l'Hôpital, 67091 Strasbourg.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ortega', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chabrier', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Busch', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uhl', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pinget', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': ''}]",Diabetes & metabolism,[]
705,16799399,Differential effects of peroxisome proliferator-activated receptor ligands and sulfonylurea plus statin treatment on plasma concentrations of adipokines in type 2 diabetes with dyslipidemia.,"OBJECTIVES


Peroxisome proliferator-activated receptor gamma is the master regulator of adipocyte differentiation and controls many adipocyte genes in response to anti-diabetic thiazolidinediones (TZDs) and lipid-lowering fibrates. We hypothesized that the combination of TZD+fibrate may be better than the sulfonylurea + statin approach regarding modifying the adipokine profile in diabetic patients with dyslipidemia.
METHODS


We measured the lipid profiles and circulating levels of adiponectin, resistin, and inflammatory markers before and after treatment in 24 type 2 diabetic patients with dyslipidemia (aged 64+/-9 years; M/F=5/19). The study patients were randomly assigned to receive an 8-week treatment of either rosiglitazone 4 mg daily and fenofibrate 160 mg daily (PPAR group) or glibenclamide 5 mg daily and atorvastatin 10 mg daily (non-PPAR group).
RESULTS


Even though the administration of sulfonylurea+statin can achieve a greater reduction of total cholesterol and LDL-cholesterol levels and a comparable glucose control compared to PPAR treatment, their administration did not change the plasma adipokine levels significantly. In contrast, a significant greater increase of the plasma concentrations of adiponectin (P<0.0001), a trend to a greater decrease of the plasma resistin levels (P=0.061), a significantly greater increase of HDL-cholesterol (P=0.002), and a significantly greater reduction of triglyceride levels (P=0.018) were seen in the PPAR group.
CONCLUSIONS


Considering the clinical significance of the adipokine-endothelial interaction in the progression and long-term prognosis of atherosclerosis, the differential effects of PPAR ligands and sulfonylurea+statin on plasma adipokine concentrations demonstrated in this study are interesting foci of investigation in the future.",2006,"In contrast, a significant greater increase of the plasma concentrations of adiponectin (P<0.0001), a trend to a greater decrease of the plasma resistin levels (P=0.061), a significantly greater increase of HDL-cholesterol (P=0.002), and a significantly greater reduction of triglyceride levels (P=0.018) were seen in the PPAR group.
","['type 2 diabetes with dyslipidemia', 'diabetic patients with dyslipidemia', '24 type 2 diabetic patients with dyslipidemia (aged 64+/-9 years']","['rosiglitazone 4 mg daily and fenofibrate 160 mg daily (PPAR group) or glibenclamide 5 mg daily and atorvastatin 10 mg daily (non-PPAR group', 'peroxisome proliferator-activated receptor ligands and sulfonylurea plus statin treatment', 'TZD+fibrate', 'sulfonylurea + statin approach', 'sulfonylurea+statin']","['plasma adipokine levels', 'triglyceride levels', 'lipid profiles and circulating levels of adiponectin, resistin, and inflammatory markers', 'plasma concentrations of adipokines', 'plasma resistin levels', 'HDL-cholesterol', 'plasma concentrations of adiponectin', 'total cholesterol and LDL-cholesterol levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1176623', 'cui_str': 'rosiglitazone 4 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1615200', 'cui_str': 'Fenofibrate 160 MG [Triglide]'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C1379772', 'cui_str': 'atorvastatin 10 MG'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0173838,"In contrast, a significant greater increase of the plasma concentrations of adiponectin (P<0.0001), a trend to a greater decrease of the plasma resistin levels (P=0.061), a significantly greater increase of HDL-cholesterol (P=0.002), and a significantly greater reduction of triglyceride levels (P=0.018) were seen in the PPAR group.
","[{'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Cheng-Hsin General Hospital, and Institute of Clinical Medicine, Cardiovascular Research Center, National Yang-Ming University, School of Medicine, Taipei, Taiwan. yin.wh@msa.hinet.net'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Jen', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Young', 'Affiliation': ''}]",Diabetes & metabolism,[]
706,30877596,Feasibility of a mindful yoga program for women with metastatic breast cancer: results of a randomized pilot study.,"PURPOSE


Patients with metastatic breast cancer (MBC) experience high levels of symptoms. Yoga interventions have shown promise for improving cancer symptoms but have rarely been tested in patients with advanced disease. This study examined the acceptability of a comprehensive yoga program for MBC and the feasibility of conducting a randomized trial testing the intervention.
METHODS


Sixty-three women with MBC were randomized with a 2:1 allocation to yoga or a support group comparison condition. Both interventions involved eight weekly group sessions. Feasibility was quantified using rates of accrual, attrition, and session attendance. Acceptability was assessed with a standardized self-report measure. Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity were assessed at baseline, post-intervention, and 3 and 6 months post-intervention.
RESULTS


We met goals for accrual and retention, with 50% of eligible patients enrolled and 87% of randomized participants completing post-intervention surveys. Sixty-five percent of women in the yoga condition and 90% in the support group attended ≥ 4 sessions. Eighty percent of participants in the yoga condition and 65% in the support group indicated that they were highly satisfied with the intervention. Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
CONCLUSIONS


Findings suggest that the yoga intervention content was highly acceptable to patients with MBC, but that there are challenges to implementing an intervention involving eight group-based in-person sessions. Alternative modes of delivery may be necessary to reach patients most in need of intervention.",2019,"Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
","['patients with advanced disease', 'Sixty-three women with MBC', 'Patients with metastatic breast cancer (MBC) experience high levels of symptoms', 'women with metastatic breast cancer']","['Yoga interventions', 'comprehensive yoga program', 'mindful yoga program']","['cancer symptoms', 'Acceptability', 'overall symptom levels', 'rates of accrual, attrition, and session attendance', 'Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",63.0,0.0666235,"Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC, 27708, USA. laura.porter@duke.edu.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, 27705, USA.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 2628, Durham, NC, 27710, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 1250 First Avenue, New York, NY, 10065, and Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Box 3459, Durham, NC, 27710, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC, 27708, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04710-7']
707,30846472,Effects of exercise and airway clearance (positive expiratory pressure) on mucus clearance in cystic fibrosis: a randomised crossover trial.,"Exercise improves mucus clearance in people without lung disease and those with chronic bronchitis. No study has investigated exercise alone for mucus clearance in cystic fibrosis (CF). The aim of this study was to compare the effects of treadmill exercise to resting breathing and airway clearance with positive expiratory pressure (PEP) therapy on mucus clearance in adults with CF.This 3-day randomised, controlled, crossover trial included 14 adults with mild to severe CF lung disease (forced expiratory volume in 1 s % predicted 31-113%). Interventions were 20 min of resting breathing (control), treadmill exercise at 60% of the participant's peak oxygen consumption or PEP therapy (including huffing and coughing). Mucus clearance was measured using the radioaerosol technique and gamma camera imaging.Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI -6- -8). When comparing treadmill exercise to PEP therapy, there were no significant differences in mucus clearance from the intermediate and peripheral lung regions, but significantly less clearance from the central lung region (likely reflecting the huffing and coughing that was only in PEP therapy).It is recommended that huffing and coughing are included to maximise mucus clearance with exercise.",2019,"Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI","['adults with CF.This 3-day randomised, controlled, crossover trial included 14\xa0adults with mild to severe CF lung disease (forced expiratory volume in 1\u2005s % predicted 31-113', 'people without lung disease and those with chronic bronchitis', 'cystic fibrosis (CF', 'cystic fibrosis']","['treadmill exercise to resting breathing and airway clearance with positive expiratory pressure (PEP) therapy', 'exercise alone', 'Treadmill exercise', ""20\u2005min of resting breathing (control), treadmill exercise at 60% of the participant's peak oxygen consumption or PEP therapy (including huffing and coughing"", 'Exercise', 'exercise and airway clearance (positive expiratory pressure']","['Mucus clearance', 'whole lung mucus clearance', 'mucus clearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0008677', 'cui_str': 'Bronchitis, Chronic'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0419023', 'cui_str': 'Positive end expiratory pressure ventilation therapy, initiation and management'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0566520', 'cui_str': 'Does huff (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]",,0.0643205,"Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2-4); however, exercise alone was less effective than PEP therapy (mean difference -7%, 95% CI","[{'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Dwyer', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia tiffany.dwyer@sydney.edu.au.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Daviskas', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Rahizan', 'Initials': 'R', 'LastName': 'Zainuldin', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Verschuer', 'Affiliation': 'Dept of PET and Nuclear Medicine, Royal\xa0Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Dept of PET and Nuclear Medicine, Royal\xa0Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Peter T P', 'Initials': 'PTP', 'LastName': 'Bye', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}]",The European respiratory journal,['10.1183/13993003.01793-2018']
708,29945673,Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection.,"BACKGROUND


Commonly in surgical randomised controlled trials (RCT) the experimental treatment is a relatively new technique which the surgeons may still be learning, while the control is a well-established standard. This can lead to biased comparisons between treatments. In this paper we discuss the implementation of approaches for addressing this issue in the ROLARR trial, and points of consideration for future surgical trials.
METHODS


ROLARR was an international, randomised, parallel-group trial comparing robotic vs. laparoscopic surgery for the curative treatment of rectal cancer. The primary endpoint was conversion to open surgery (binary). A surgeon inclusion criterion mandating a minimum level of experience in each technique was incorporated. Additionally, surgeon self-reported data were collected periodically throughout the trial to capture the level of experience of every participating surgeon. Multi-level logistic regression adjusting for operating surgeon as a random effect is used to estimate the odds ratio for conversion to open surgery between the treatment groups. We present and contrast the results from the primary analysis, which did not account for learning effects, and a sensitivity analysis which did.
RESULTS


The primary analysis yields an estimated odds ratio (robotic/laparoscopic) of 0.614 (95% CI 0.311, 1.211; p = 0.16), providing insufficient evidence to conclude superiority of robotic surgery compared to laparoscopic in terms of the risk of conversion to open. The sensitivity analysis reveals that while participating surgeons in ROLARR were expert at laparoscopic surgery, some, if not all, were still learning robotic surgery. The treatment-effect odds ratio decreases by a factor of 0.341 (95% CI 0.121, 0.960; p = 0.042) per unit increase in log-number of previous robotic operations performed by the operating surgeon. The odds ratio for a patient whose operating surgeon has the mean experience level in ROLARR - 152.46 previous laparoscopic, 67.93 previous robotic operations - is 0.40 (95% CI 0.168, 0.953; p = 0.039).
CONCLUSIONS


In this paper we have demonstrated the implementation of approaches for accounting for learning in a practical example of a surgery RCT analysis. The results demonstrate the value of implementing such approaches, since we have shown that without them the ROLARR analysis would indeed have been confounded by the learning effects.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number (ISRCTN) registry, ID: ISRCTN80500123. Registered on 27 May 2010.",2018,"The primary analysis yields an estimated odds ratio (robotic/laparoscopic) of 0.614 (95% CI 0.311, 1.211; p = 0.16), providing insufficient evidence to conclude superiority of robotic surgery compared to laparoscopic in terms of the risk of conversion to open.","['rectal cancer resection', 'rectal cancer']","['robotic vs. laparoscopic surgery', 'robotic-assisted vs. standard laparoscopic surgery']",['conversion to open surgery (binary'],"[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3494226', 'cui_str': 'Conversion to an Open Surgical Procedure'}]",,0.233094,"The primary analysis yields an estimated odds ratio (robotic/laparoscopic) of 0.614 (95% CI 0.311, 1.211; p = 0.16), providing insufficient evidence to conclude superiority of robotic surgery compared to laparoscopic in terms of the risk of conversion to open.","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Corrigan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. n.corrigan@leeds.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Croft', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': ""Department of Academic Surgery, Leeds Institute of Biological and Clinical Sciences, Clinical Sciences Building, University of Leeds, St. James's University Hospital, Leeds, LS9 7TF, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}]",Trials,['10.1186/s13063-018-2726-0']
709,16735965,Reinforced follow-up for children and adolescents with type 1 diabetes and inadequate glycaemic control: a randomized controlled trial intervention via the local pharmacist and telecare.,"AIM


To evaluate the effectiveness and feasibility of reinforced follow-up via telecare mediated by the local pharmacist in contact with the hospital team to improve glycaemic control in children and adolescents with type 1 diabetes (DT1).
METHODS


One hundred patients, aged 8 to 17 years, with a history of DT1 of more than 1 year, with HbA(1c) >=8%, were randomly assigned to either the ""reinforced follow-up"" group (RFG) or the ""usual follow-up"" group (UFG). The intervention consisted in downloading and then printing data stored in a glucometer every two weeks, by the local pharmacist. Printouts were faxed to the hospital team which then communicated adapted instructions for better glycemic control directly to the family.
RESULTS


Fifty patients were assigned to each group. The two groups were comparable at the beginning. 71 children had a doctor's visit at 6 +/- 1 months (36 in RFG and 35 in UFG). At this date, there was no significant difference between the average HbA(1c) levels of the two groups (9.12 +/- 1.46 in RFG versus 9.27 +/- 1.20 in UFG). We had various difficulties setting up and gaining compliance with the intervention procedure, which explains why only 33 children in the RFG transmitted at least one fax.
CONCLUSION


At this stage, the reinforced follow-up has not proved to be superior to the usual follow-up. However, it would be possible to make numerous improvements in order to make the former more feasible and probably more efficient.",2006,"At this date, there was no significant difference between the average HbA(1c) levels of the two groups (9.12 +/-","['children and adolescents with type 1 diabetes (DT1', 'One hundred patients, aged 8 to 17 years, with a history of DT1 of more than 1 year, with HbA(1c) >=8', 'children and adolescents with type 1 diabetes and inadequate glycaemic control', ""71 children had a doctor's visit at 6 "", '33 children in the RFG transmitted at least one fax', 'Fifty patients']","['reinforced follow-up"" group (RFG) or the ""usual follow-up"" group (UFG']",['average HbA(1c) levels'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0085205', 'cui_str': 'Fax'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",50.0,0.04445,"At this date, there was no significant difference between the average HbA(1c) levels of the two groups (9.12 +/-","[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Gay', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, Debrousse University Hospital, Lyon, France. claire-lise.gay@chu-lyon.fr'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chapuis', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bendelac', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tixier', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Treppoz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nicolino', 'Affiliation': ''}]",Diabetes & metabolism,[]
710,15223987,"Indicators of abdominal adiposity in middle-aged participants of the SU.VI.MAX study: relationships with educational level, smoking status and physical inactivity.","OBJECTIVES


Abdominal fat accumulation is a risk factor for type 2 diabetes and cardiovascular disease. Identifying the demographic and lifestyle correlates of abdominal adiposity is an important step to target at-risk populations in prevention programs. There are few data of this kind in France.
METHODS


Anthropometric indicators of overall (body mass index, BMI) and abdominal (waist hip ratio, WHR; waist circumference, WC) adiposity, educational level, smoking status, and physical activity were assessed in 6,705 middle-aged men and women participating in the SU.VI.MAX study.
RESULTS


The likelihood of being obese was increased more than twice in physically inactive subjects of both genders after adjustment for age, smoking status and educational level (OR=2.22, CI95%: 1.74-2.83 in men; OR=2.38, CI95%: 1.84-3.09 in women). Having a high WHR (>=0.95 in men, >=0.80 in women) was more likely in subjects >=50 y, in current smokers, and less likely in men with higher education. The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level (OR=1.33, CI95%: 1.10-1.60 in men; OR=1.46, CI95%: 1.22-1.74 in women). Having a high WC (>=102 cm in men, >=88 cm in women) was positively associated with age and also with physical inactivity (OR=1.63, CI95%: 1.20-2.22 in women).
CONCLUSIONS


These cross-sectional data suggest significant positive associations of physical inactivity with both the WHR and WC, independently of overall adiposity as assessed by the BMI.",2004,"The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level","['6,705 middle-aged men and women participating in the SU.VI.MAX study', 'middle-aged participants of the SU.VI.MAX study: relationships with educational level, smoking status and physical inactivity']",[],"['likelihood of being obese', 'BMI, smoking status and educational level', 'physical inactivity', 'likelihood of having a high WHR', 'overall (body mass index, BMI) and abdominal (waist hip ratio, WHR; waist circumference, WC) adiposity, educational level, smoking status, and physical activity', 'abdominal adiposity', 'smoking status and educational level']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",6705.0,0.0641574,"The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': ""INSERM U557, Institut scientifique et technique de la Nutrition et de l'Alimentation, UMR (INSERM/INRA/CNAM), 5, rue Vertbois, 75003 Paris, France. sebastien.czernichow@cnam.fr""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bertrais', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Preziosi', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Galan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hercberg', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Oppert', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70101-5']
711,30578395,Fibroblast growth factor 21 predicts outcome in community-acquired pneumonia: secondary analysis of two randomised controlled trials.,"Acute systemic inflammatory conditions are accompanied by profound alterations of metabolism. However, the role of fibroblast growth factor 21 (FGF21), a recently identified central regulator of metabolism, is largely unknown in community-acquired pneumonia (CAP). This study aims to characterise the pattern of FGF21 in pneumonia and associations with disease severity and outcome.This is a secondary analysis of two independent multicentre randomised controlled trials in patients presenting to the emergency department with CAP. Primary and secondary efficacy parameters included 30-day mortality, length of hospital stay, time to clinical stability and duration of antibiotic treatment.A total of 509 patients were included in the analysis. FGF21 levels at admission strongly correlated with disease severity, as measured by the Pneumonia Severity Index. Increased levels of FGF21 were associated with prolonged time to clinical stability, antibiotic treatment and hospitalisation. FGF21 levels at admission were significantly higher in nonsurvivors than in survivors, yielding a 1.61-fold increased adjusted odds ratio of 30-day mortality (95% CI 1.21-2.14; p=0.001). Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.Moderate-to-severe CAP patients with higher levels of FGF21 were at increased risk for clinical instability, prolonged hospitalisation and 30-day all-cause mortality.",2019,"Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.","['patients presenting to the emergency department with CAP', 'community-acquired pneumonia', 'A total of 509 patients were included in the analysis']","['Fibroblast growth factor 21', 'FGF21']","['Pneumonia Severity Index', 'FGF21 levels at admission', 'Increased levels of FGF21', '30-day mortality', 'clinical stability, antibiotic treatment and hospitalisation', 'FGF21 levels', '30-day mortality, length of hospital stay, time to clinical stability and duration of antibiotic treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}]","[{'cui': 'C1321595', 'cui_str': 'Pneumonia severity of illness index'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",509.0,0.147542,"Moreover, FGF21 was found to identify patients for 30-day mortality with superior discriminative power compared with routine diagnostic markers.","[{'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Wolffenbuttel', 'Affiliation': 'Dept of Internal Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Claudine A', 'Initials': 'CA', 'LastName': 'Blum', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Dept of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'University Dept of Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'University Dept of Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meier', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Kraenzlin', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias Johannes', 'Initials': 'MJ', 'LastName': 'Betz', 'Affiliation': 'Dept of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",The European respiratory journal,['10.1183/13993003.00973-2018']
712,31493887,Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization.,"BACKGROUND


Peanut sublingual immunotherapy (SLIT) for 1 year has been shown to induce modest clinical desensitization in allergic children. Studies of oral immunotherapy, epicutaneous immunotherapy, and SLIT have suggested additional benefit with extended treatment.
OBJECTIVE


We sought to investigate the safety, clinical effectiveness, and immunologic changes with long-term SLIT in children with peanut allergy.
METHODS


Children with peanut allergy aged 1 to 11 years underwent extended maintenance SLIT with 2 mg/d peanut protein for up to 5 years. Subjects with peanut skin test wheals of less than 5 mm and peanut-specific IgE levels of less than 15 kU/L were allowed to discontinue therapy early. Desensitization was assessed through a double-blind, placebo-controlled food challenge (DBPCFC) with up to 5000 mg of peanut protein after completion of SLIT dosing. Sustained unresponsiveness was further assessed by using identical DBPCFCs after 2 to 4 weeks without peanut exposure.
RESULTS


Thirty-seven of 48 subjects completed 3 to 5 years of peanut SLIT, with 67% (32/48) successfully consuming 750 mg or more during DBPCFCs. Furthermore, 25% (12/48) passed the 5000-mg DBPCFC without clinical symptoms, with 10 of these 12 demonstrating sustained unresponsiveness after 2 to 4 weeks. Side effects were reported with 4.8% of doses, with transient oropharyngeal itching reported most commonly. Side effects requiring antihistamine treatment were uncommon (0.21%), and no epinephrine was administered. Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
CONCLUSION


Extended-therapy peanut SLIT provided clinically meaningful desensitization in the majority of children with peanut allergy that was balanced with ease of administration and a favorable safety profile.",2019,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","['Children with peanut allergy aged 1 to 11\xa0years underwent', 'children', 'allergic children', 'children with peanut allergy', 'Thirty-seven of 48 subjects completed 3 to 5\xa0years of peanut SLIT, with 67% (32/48) successfully consuming 750\xa0mg or more during DBPCFCs']","['oral immunotherapy, epicutaneous immunotherapy, and SLIT', 'placebo-controlled food challenge (DBPCFC', 'sublingual immunotherapy', 'epinephrine', 'Peanut sublingual immunotherapy (SLIT', 'extended maintenance SLIT with 2\xa0mg/d peanut protein', 'antihistamine']","['Peanut skin test wheals, peanut-specific IgE levels, and basophil activation', 'Side effects', 'peanut-specific IgG 4  levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",48.0,0.108432,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Luanna', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Rishu', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kulis', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.030']
713,30811543,Disseminating Tai Chi in the Community: Promoting Home Practice and Improving Balance.,"BACKGROUND AND OBJECTIVES


Falls among older adults is a pressing public health challenge. Considerable research documents that longer tai chi courses can reduce falls and improve balance. However, longer courses can be challenging to implement. Our goal was to evaluate whether a short 6-week modified tai chi course could be effective at reducing falls risk if older adults designed a personal home practice plan to receive a greater tai chi ""dose"" during the 6 weeks.
DESIGN


A 3-city wait-listed randomized trial was conducted. Habituation Intention and Social Cognitive Theories framed the ""coaching"" strategy by which participants designed practice plans. RE-AIM and Treatment Fidelity Frameworks were used to evaluate implementation and dissemination issues. Three advisory groups advised the study on intervention planning, implementation, and evaluation. To measure effectiveness, we used Centers for Disease Control and Prevention recommended measures for falls risk including leg strength, balance, and mobility and gait. In addition, we measured balance confidence and executive function.
RESULTS


Program Implementation resulted in large class sizes, strong participant retention, high program fidelity and effectiveness. Participants reported practicing an average of 6 days a week and more than 25 min/day. Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
CONCLUSION


The tai chi short course resulted in substantial tai chi practice by older adults outside of class as well as better physical and executive function. The course reach, retention, fidelity, and implementation across 3 cities suggest strong potential for implementation and dissemination of the 6-week course.",2020,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
",['older adults'],['tai chi'],"['large class sizes, strong participant retention, high program fidelity and effectiveness', 'Leg strength, tandem balance, mobility and gait, balance confidence, and executive function', 'balance confidence and executive function', 'course reach, retention, fidelity, and implementation', 'falls risk including leg strength, balance, and mobility and gait', 'substantial tai chi practice']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557314', 'cui_str': 'Number of pupils in class (observable entity)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]",,0.0343028,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Chewning', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hallisy', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Family Medicine and Community Health.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Nisaratana', 'Initials': 'N', 'LastName': 'Sangasubana', 'Affiliation': 'Sonderegger Research Center, School of Pharmacy.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Population Health, Department of Population Health Sciences.'}]",The Gerontologist,['10.1093/geront/gnz006']
714,15959426,Effects of micronized fenofibrate and vitamin E on in vitro oxidation of lipoproteins in patients with type 1 diabetes mellitus.,"OBJECTIVE


The primary objective was to compare the antioxidant activity of micronised fenofibrate 200 mg to 400 IU of vitamin E and placebo, on the LDL and VLDL particles of patients with type 1 diabetes. The secondary objective was to investigate the possible synergy between micronized fenofibrate and vitamin E and to compare the efficacy of these treatments on lipids.
METHODS


A double-blind, placebo-controlled trial in which patients were randomised into three treatment groups after a wash-out period of 8 weeks: the placebo group (Pla/Pla-group) in which patients received placebo during two consecutive periods of 8 weeks, the vitamin E group (Vit E/Vit E-group) in which patients received Vitamin E during two consecutive periods, and the fenofibrate/Vitamin E group (Fen/Fen + Vit E-group) in which patients received fenofibrate during the first period, followed by fenofibrate and vitamin E during the consecutive period. Blood samples taken at each visit, were analysed for routine biochemistry, blood lipids and copper mediated lipid peroxidation in vitro.
RESULTS


The lag time of the non-HDL lipoprotein oxidation increased in the group given fenofibrate. The lag-time increased further when fenofibrate and vitamin E were given in association. (This reached significance in the intention-to-treat population, P = 0.034). The AUC of TBARS formation in the Vit E/Vit E group decreased after the first period, but this effect was not enhanced by continuing vitamin E for another 8 weeks. The AUC of TBARS formation did not change significantly after the administration of fenofibrate. Only after the second period, when vit E was given in association, the AUC of TBARS formation decreased significantly (P = 0.004). Fenofibrate caused a significant decrease in total and LDL-cholesterol and triglycerides (P < 0.05). In contrast, vitamin E had no effect on lipids.
CONCLUSIONS


The combination of micronized fenofibrate 200 mg/day and vitamin E 400 IU/day tended to increase the resistance of non-HDL lipoproteins to copper-mediated oxidation, shown by a prolongation of the lag-time. Vitamin E administration only, decreased the oxidation of non-HDL lipoproteins shown by a reduction of TBARS formation. This protective effect of vitamin E tended to be amplified by micronized fenofibrate.",2005,Fenofibrate caused a significant decrease in total and LDL-cholesterol and triglycerides (P < 0.05).,"['patients with type 1 diabetes mellitus', 'patients with type 1 diabetes']","['micronised fenofibrate', 'placebo', 'micronized fenofibrate and vitamin E', 'micronized fenofibrate', 'fenofibrate/Vitamin E group (Fen/Fen + Vit E-group', 'vitamin E', 'Fenofibrate', 'vitamin E and placebo', 'vitamin E group (Vit E/Vit E-group) in which patients received Vitamin E', 'Vitamin E', 'fenofibrate', 'fenofibrate and vitamin E']","['resistance of non-HDL lipoproteins', 'oxidation of non-HDL lipoproteins', 'antioxidant activity', 'lipids', 'TBARS formation', 'lag time of the non-HDL lipoprotein oxidation', 'AUC of TBARS formation', 'vitro oxidation of lipoproteins', 'total and LDL-cholesterol and triglycerides', 'lag-time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023821', 'cui_str': 'alpha-Lipoproteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.145703,Fenofibrate caused a significant decrease in total and LDL-cholesterol and triglycerides (P < 0.05).,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Engelen', 'Affiliation': 'Department of Diabetology, Metabolism and Clinical Nutrition, Faculty of Medicine, University Hospital of Antwerp, UZA, Wilrijkstraat 10, 2650 Edegem, Antwerp, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Manuel-y-Keenoy', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vertommen', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'De Leeuw', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Gaal', 'Affiliation': ''}]",Diabetes & metabolism,[]
715,31705201,Effects and side effects of a transdiagnostic bias modification intervention in a mixed sample with obsessive-compulsive and/or depressive symptoms-a randomized controlled trial.,"Obsessive-compulsive disorder (OCD) and major depression disorder (MDD) are underdiagnosed and undertreated mental disorders. Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD. As depression and OCD share a number of (meta)cognitive biases and dysfunctional coping strategies, we examined the efficacy of myMCT in a mixed patient sample with OCD and/or depression. A total of 80 Italian-speaking individuals with symptoms of OCD and/or depression were randomized to either myMCT or to a waitlist control group (both groups had access to care as usual during the intervention). Post-assessment was carried out 6 weeks after inclusion. Scores on the Beck Depression Inventory-II scale (BDI-II) served as the primary outcome. Adverse effects were assessed with a newly devised self-report scale. Participants in the myMCT condition showed significant symptom improvement on the BDI-II scale at a medium to large effect size compared to the control group (using intention-to-treat and per protocol analyses). The intention-to-treat analyses yielded significant positive effects on the PHQ-9 scores and psychological as well as environmental well-being in favor of myMCT; for the OCI-R total score, group differences bordered significance in favor of the myMCT. The most prevalent adverse effects were feeling pressured by the suggested exercises or feeling bad due to not performing the exercises correctly. Our results indicate that the myMCT manual represents an effective program for patients with OCD as well as those with depressive symptoms in an Italian-speaking population. Adverse events due to unguided self-help deserve more attention in the future.",2020,Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD.,"['patients with OCD', 'mixed sample with obsessive-compulsive and/or depressive symptoms', 'patients with primary OCD', '80 Italian-speaking individuals with symptoms of OCD and/or depression']","['myMCT', 'waitlist control group (both groups had access to care as usual during the intervention', 'myMCT manual', 'self-help manual My Metacognitive Training (myMCT', 'transdiagnostic bias modification intervention']","['Beck Depression Inventory-II scale (BDI-II', 'PHQ-9 scores and psychological', 'Obsessive-compulsive disorder (OCD', 'BDI-II scale', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0505289,Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD.,"[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany. moritz@uke.de.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Bernardini', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Lion', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-01080-3']
716,31558473,Analysis of Biomarkers and Association With Clinical Outcomes in Patients With Differentiated Thyroid Cancer: Subanalysis of the Sorafenib Phase III DECISION Trial.,"PURPOSE


The phase III DECISION trial (NCT00984282; EudraCT:2009-012007-25) established sorafenib efficacy in locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) refractory to radioactive iodine. We conducted a retrospective, exploratory biomarker analysis of patients from DECISION.
EXPERIMENTAL DESIGN


Candidate biomarkers [15 baseline plasma proteins, baseline and during-treatment serum thyroglobulin, and relevant tumor mutations ( BRAF ,  NRAS ,  HRAS , and  KRAS )] were analyzed for correlation with clinical outcomes.
RESULTS


Plasma biomarker and thyroglobulin data were available for 395 of 417 (94.7%) and 403 of 417 (96.6%) patients, respectively. Elevated baseline VEGFA was independently associated with poor prognosis for progression-free survival [PFS; HR = 1.82; 95% confidence interval (CI), 1.38-2.44;  P  = 0.0007], overall survival (HR = 2.13; 95% CI, 1.37-3.36;  P  = 0.013), and disease-control rate (DCR; OR = 0.30;  P  = 0.009). Elevated baseline thyroglobulin was independently associated with poor PFS (HR = 2.03; 95% CI, 1.52-2.71;  P  < 0.0001) and DCR (OR = 0.32;  P  = 0.01). Combined VEGFA/thyroglobulin signatures correlated with poor PFS (HR = 2.12; 95% CI, 1.57-2.87;  P  < 0.00001). Thyroglobulin decrease ≥30% from baseline was achieved by 76% and 14% of patients receiving sorafenib and placebo, respectively ( P  < 0.001). Patients with ≥30% thyroglobulin reduction had longer PFS than those without ≥30% reduction [HR (95% CI): sorafenib = 0.61 (0.40-0.94),  P  = 0.022; placebo = 0.49 (0.29-0.85),  P  = 0.009].  BRAF  mutations were associated with better PFS;  RAS  mutations were associated with worse PFS, although neither was independently prognostic in multivariate models. No examined biomarker predicted sorafenib benefit.
CONCLUSIONS


We identified biomarkers associated with poor prognosis in DTC, including elevated baseline VEGFA and thyroglobulin and the presence of  RAS  mutations. Serum thyroglobulin may be a biomarker of tumor response and progression.",2019,"Elevated baseline vascular endothelial growth factor A (VEGF-A) was independently associated with poor prognosis for progression-free survival (PFS; hazard ratio [HR]=1.82 [95% CI, 1.38-2.44],  P =0.0007), overall survival (HR=2.13 [95% CI, 1.37‒3.36],  P =0.013), and disease-control rate (DCR; odds ratio [OR]=0.30,  P =0.009).","['locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) refractory to radioactive iodine', 'Patients With Differentiated Thyroid Cancer', 'patients from DECISION']","['sorafenib and placebo', 'Sorafenib']","['Elevated baseline vascular endothelial growth factor A (VEGF-A', 'Elevated baseline thyroglobulin', 'disease-control rate', 'longer PFS', 'overall survival', 'Plasma biomarker and thyroglobulin data', 'serum thyroglobulin, relevant tumor mutations [BRAF, NRAS, HRAS, KRAS', 'DCR']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0337445', 'cui_str': 'Thyroglobulin measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",,0.268569,"Elevated baseline vascular endothelial growth factor A (VEGF-A) was independently associated with poor prognosis for progression-free survival (PFS; hazard ratio [HR]=1.82 [95% CI, 1.38-2.44],  P =0.0007), overall survival (HR=2.13 [95% CI, 1.37‒3.36],  P =0.013), and disease-control rate (DCR; odds ratio [OR]=0.30,  P =0.009).","[{'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania. brosem@pennmedicine.upenn.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schlumbeger', 'Affiliation': 'Gustave Roussy and University Paris Saclay, Villejuif, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeffers', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kappeler', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Gerold', 'Initials': 'G', 'LastName': 'Meinhardt', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}, {'ForeName': 'Carol E A', 'Initials': 'CEA', 'LastName': 'Peña', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3439']
717,15671911,Effect of systemic vitamin C on free fatty acid-induced lipid peroxidation.,"OBJECTIVES


Plasma malondialdehyde (MDA), a reactive product of lipid peroxidation, may be influenced by anti-oxidant therapy. The aim of the present study was to investigate if elevated MDA as induced by increased free fatty acids (FFA) correlates with endothelial function and is affected by high doses of vitamin C.
METHODS


The study design was randomised, placebo-controlled, double blind, 2-way cross over. Plasma MDA concentrations and forearm blood flow (FBF) responses to intra-arterial acetylcholine (ACh) and glyceryl trinitrate were assessed during co-administration of vitamin C or placebo in the presence of increased plasma FFA by Intralipid/heparin infusion in 10 healthy male subjects.
RESULTS


The seven-fold rise in plasma FFA was associated with an increase in plasma MDA concentrations (r=0.7, p<0.001) and decreased FBF responses to ACh (r=-0.4, p<0.01). Co-administration of vitamin C restored the impaired reactivity of FBF to ACh but had no effect on elevated MDA concentrations.
CONCLUSIONS


Anti-oxidant vitamin C improves lipid-induced impairment of endothelium-dependent vasodilation, but does not alter MDA formation or breakdown.",2004,"The seven-fold rise in plasma FFA was associated with an increase in plasma MDA concentrations (r=0.7, p<0.001) and decreased FBF responses to ACh (r=-0.4, p<0.01).",['10 healthy male subjects'],"['placebo', 'systemic vitamin C', 'vitamin C or placebo', 'vitamin C', 'Co']","['plasma MDA concentrations', 'FBF responses', 'Plasma MDA concentrations and forearm blood flow (FBF) responses to intra-arterial acetylcholine (ACh) and glyceryl trinitrate', 'plasma FFA', 'elevated MDA concentrations', 'free fatty acid-induced lipid peroxidation']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial (qualifier value)'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}]",10.0,0.390624,"The seven-fold rise in plasma FFA was associated with an increase in plasma MDA concentrations (r=0.7, p<0.001) and decreased FBF responses to ACh (r=-0.4, p<0.01).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bayerle-Eder', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pleiner', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mittermayer', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schaller', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Waldhäusl', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bieglmayer', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': ''}]",Diabetes & metabolism,[]
718,16434933,[Neuroleptic drug utilization among schizophrenic outpatients].,"BACKGROUND


Our objective was to describe and compare neuroleptic drug utilization patterns among French schizophrenic outpatients in public and private care settings.
METHODS


A cross sectional survey was carried out by a random sample of 61 public and 112 private psychiatrists who registered for one month all schizophrenic adult outpatients treated with a neuroleptic drug. Among registered patients, each psychiatrist was to include a maximum of 18 patients (public setting) or 9 patients (private setting). Statistical analysis was weighted to take into account for psychiatrist activity level, assessed by patient registration.
RESULTS


Psychiatrists included 934 patients in the public care setting and 927 patients in the private care setting. Patients were (mean+/-sd) 40.1+/-12.1 years old, 60.9% men. The patients' social and clinical characteristics were less favorable in the public setting than in the private setting: no professional activity (78.9% vs 65.1%), living in institution (7.2% vs 3.7%), under legal protection (35.1% vs 14.5%), drug abuse (9.6% vs 5.6%). An atypical neuroleptic was prescribed for 63.0% of patients and a classic neuroleptic for 49.7%, an association of neuroleptics for 22.0%. In both settings, the most prescribed neuroleptics were olanzapine (28.0%) and risperidone (18.6%) with a higher mean daily dosage in the public care setting. At least one neuroleptic treatment change (drug and/or dosage) occurred during the previous year for 44.9% and 39.2% patients, in public and private settings, respectively. In both settings, reasons for changes were mainly lack of efficacy (55.1%) and side effects (49.8%).
CONCLUSION


Public and private care populations were different but not as much as expected. In both settings, atypical neuroleptics were the predominant drugs used in the treatment of schizophrenia outpatients. The high frequency of drug change for lack of efficacy or side effects demonstrates the difficulties with the use of the present neuroleptic armamentarium.",2005,"The patients' social and clinical characteristics were less favorable in the public setting than in the private setting: no professional activity (78.9% vs 65.1%), living in institution (7.2% vs 3.7%), under legal protection (35.1% vs 14.5%), drug abuse (9.6% vs 5.6%).","['registered patients, each psychiatrist was to include a maximum of 18 patients (public setting) or 9 patients (private setting', 'Patients were (mean+/-sd) 40.1+/-12.1 years old, 60.9% men', 'French schizophrenic outpatients in public and private care settings', 'schizophrenic outpatients', 'A cross sectional survey was carried out by a random sample of 61 public and 112 private psychiatrists who registered for one month all schizophrenic adult outpatients treated with a neuroleptic drug', '934 patients in the public care setting and 927 patients in the private care setting']","['olanzapine', 'risperidone']","['professional activity', 'side effects', 'drug abuse', 'under legal protection']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C1301860', 'cui_str': 'Legal'}]",934.0,0.0197903,"The patients' social and clinical characteristics were less favorable in the public setting than in the private setting: no professional activity (78.9% vs 65.1%), living in institution (7.2% vs 3.7%), under legal protection (35.1% vs 14.5%), drug abuse (9.6% vs 5.6%).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Blin', 'Affiliation': 'Département de Pharmacologie, Université Victor-Segalen/Bordeaux 2, Carreire zone Nord, case 36, 33076 Bordeaux Cedex. patrick.blin@pharmaco.u-bordeaux2.fr'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Olié', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sechter', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Petitjean', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cialdella', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gérard', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hanssens', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westerloppe', 'Affiliation': ''}]",Revue d'epidemiologie et de sante publique,[]
719,30599145,Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia.,"INTRODUCTION


During vocalization, efference copy/corollary discharge mechanisms suppress the auditory cortical response to self-generated sounds as reflected in the N1 component of the auditory event-related potential (ERP). N1 suppression during talking is reduced in patients with schizophrenia. We hypothesized that these deficits would recover with auditory training that targets the speech processing system.
METHODS


Forty-nine individuals early in the course of a schizophrenia-spectrum illness (ESZ) were randomly assigned to 40 h of Targeted Auditory Training (TAT; n = 23) or Computer Games (CG; n = 26). The N1 ERP component was elicited during production (Talk) and playback (Listen) of vocalization. Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed. Simple effects of the passage of time were also assessed in the HC after 28 weeks.
RESULTS


There was a Treatment × Time interaction revealing that N1 suppression was improved with TAT, but not with CG. TAT, but not CG, also improved Global Cognition. However, TAT and CG groups differed in their pre-treatment N1 suppression, and greater N1-suppression abnormalities were strongly associated with greater improvement in N1 suppression.
CONCLUSIONS


In this sample of ESZ individuals, targeted auditory training appeared to improve the function of the efference copy/corollary discharge mechanism which tended to deteriorate with computer games. It remains to be determined if baseline N1 suppression abnormalities are necessary for TAT treatment to have a positive effect on efference copy/corollary discharge function or if improvements observed in this study represent a regression to the mean N1 suppression in ESZ.
TRIAL REGISTRATION


ClinicalTrials.govNCT00694889. Registered 1 August 2007.",2019,"Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed.","['Forty-nine individuals early in the course of a schizophrenia-spectrum illness (ESZ', 'patients with schizophrenia']","['Targeted Auditory Training (TAT; n\u202f=\u202f23) or Computer Games (CG', 'cognitive training', 'auditory training', 'TAT']","['N1-suppression abnormalities', 'N1 suppression', 'Efference copy/corollary discharge function', 'Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening', 'Global Cognition']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",,0.0568286,"Effects of Treatment on Global Cognition, N1 suppression (Talk-Listen), N1 during Talking and Listening were assessed.","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'San Francisco VA Healthcare System, United States of America. Electronic address: brian.roach@ncire.org.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': 'University of California at San Francisco, United States of America; San Francisco VA Healthcare System, United States of America. Electronic address: Judith.ford@ucsf.edu.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Biagianti', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: bruno.biagianti@positscience.com.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Hamilton', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: holly.hamilton@ucsf.edu.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: ramsa045@umn.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: mafisher@umn.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'University of California at San Francisco, United States of America. Electronic address: rachel.loewy@ucsf.edu.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'University of Minnesota, United States of America. Electronic address: svinogra@umn.edu.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California at San Francisco, United States of America; San Francisco VA Healthcare System, United States of America. Electronic address: daniel.mathalon@ucsf.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2018.12.015']
720,16142016,Repaglinide has more beneficial effect on cardiovascular risk factors than glimepiride: data from meal-test study.,"Aim our study is to compare the effects of repaglinide vs glimepiride administration on cardiovascular risk factors after meal test. Thus, after 2 weeks washout period, a 3-month randomised, cross-over parallel group trial of repaglinide (1 mg x 2/day) vs glimepiride (2 mg/day) in 14 patients with type 2 diabetes ""naive"" on diet treatment was made. Both treatments significantly declined plasma glucose, total-cholesterol, LDL-cholesterol, triglycerides, PAI-1, PAP levels and increased HDL-cholesterol. Lowering in plasma PAI-1 and PAP levels was significantly greater in repaglinide group. Furthermore, repaglinide administration resulted in a significant decrease in fasting plasma free fatty acids, fibrinogen, thrombin-antithrombin complex and reaction product of malondialdehyde with thiobarbituric acid (TBARS) levels, in absence of significant difference in fasting plasma insulin levels. Decrease in plasma TBARS levels correlated with the decrease in Plasminogen Activator Inhibitor-1 (r = 0.72; P < 0.003) and free fatty acids concentrations (r = 0.62; P < 0.01). Analysis of the insulin and glucose concentrations throughout the meal test revealed that AUC for glucose (758 +/- 19 vs 780 +/- 28 mg/Lxmin; P = 0.02) was significantly lower after repaglinide than glimepiride administration despite similar AUC for insulin (2327 +/- 269 vs 2148 +/- 292 mU/Lxmin; P = 0.105). At time 120' of meal test, repaglinide vs glimepiride administration was associated with a significant decline in plasma triglycerides, free fatty acids, fibrinogen, Plasminogen Activator Inhibitor-1, plasmin-alpha(2)-antiplasmin complex, thrombin-antithrombin complex, TBARS levels and increase in plasma HDL-cholesterol levels. In repaglinide group a negative correlation between insulin secretion during 1st phase of meal-test and plasma TBARS levels (r = -0.55; P < 0.03) at time 120' was found. Such correlation was lost after adjusting for changes in postprandial hyperglycaemia (r = -0.48; P < 0.09). In conclusion, our results support the hypothesis that repaglinide is more efficient than glimepiride on controlling for postprandial glucose excursion and may have beneficial effect on reducing cardiovascular risk factors.",2005,"Both treatments significantly declined plasma glucose, total-cholesterol, LDL-cholesterol, triglycerides, PAI-1, PAP levels and increased HDL-cholesterol.",['14 patients with type 2 diabetes'],"['Repaglinide', 'naive"" on diet treatment', 'glimepiride', 'repaglinide vs glimepiride', 'repaglinide']","['Plasminogen Activator Inhibitor-1', 'insulin secretion', 'cardiovascular risk factors', 'postprandial glucose excursion', 'plasma glucose, total-cholesterol, LDL-cholesterol, triglycerides, PAI-1, PAP levels and increased HDL-cholesterol', 'insulin and glucose concentrations', 'plasma triglycerides, free fatty acids, fibrinogen, Plasminogen Activator Inhibitor-1, plasmin-alpha(2)-antiplasmin complex, thrombin-antithrombin complex, TBARS levels and increase in plasma HDL-cholesterol levels', 'plasma PAI-1 and PAP levels', 'plasma TBARS levels', 'fasting plasma free fatty acids, fibrinogen, thrombin-antithrombin complex and reaction product of malondialdehyde with thiobarbituric acid (TBARS) levels', 'postprandial hyperglycaemia', 'free fatty acids concentrations', 'fasting plasma insulin levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0853084', 'cui_str': 'Increased HDL'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0760170', 'cui_str': 'alpha 2-plasmin inhibitor-plasmin complex'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1278148', 'cui_str': 'Plasma HDL cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}]",14.0,0.0266729,"Both treatments significantly declined plasma glucose, total-cholesterol, LDL-cholesterol, triglycerides, PAI-1, PAP levels and increased HDL-cholesterol.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rizzo', 'Affiliation': 'Department of Geriatrics and Metabolic Diseases, II University of Naples, Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grella', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Passariello', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': ''}]",Diabetes & metabolism,[]
721,15223977,Oral magnesium supplementation improves insulin sensitivity in non-diabetic subjects with insulin resistance. A double-blind placebo-controlled randomized trial.,"OBJECTIVE


Although hypomagnesemia reduces insulin sensitivity, benefits of magnesium supplementation to non-diabetic insulin resistant subjects has not been established. Our purpose was to determine whether oral magnesium supplementation with magnesium chloride (MgCl2) 2.5 g daily modify insulin sensitivity in non-diabetic subjects.
MATERIAL AND METHODS


This study was a 3 months randomized double-blind placebo-controlled trial. Apparently healthy subjects were eligible to participate if they had insulin resistance (HOMA-IR index equal or greater than 3.0) and hypomagnesemia (Serum magnesium levels equal or lower than 0.74 mmol/l). Subjects were randomized to receive either, MgCl2 2.5 g daily or placebo by 3-months.
RESULTS


At baseline there were not significant anthropometric or laboratory differences between both groups. At ending of the study, magnesium-supplemented subjects significantly increased their serum magnesium levels (0.61 +/- 0.08 to 0.81 +/- 0.08 mmol/l, p<0.0001) and reduced HOMA-IR index (4.6 +/- 2.8 to 2.6 +/- 1.1, p<0.0001), whereas control subjects did not (0.62 +/- 0.08 to 0.61 +/- 0.08 mmol/l, p=0.063 and 5.2 +/- 1.9 to 5.3 +/- 2.9, p=0.087).
CONCLUSIONS


Oral magnesium supplementation improves insulin sensitivity in hypomagnesemic non-diabetic subjects. Clinical implications of this finding have to be established.",2004,At baseline there were not significant anthropometric or laboratory differences between both groups.,"['hypomagnesemic non-diabetic subjects', 'Apparently healthy subjects were eligible to participate if they had insulin resistance (HOMA-IR index equal or greater than 3.0) and hypomagnesemia (Serum magnesium levels equal or lower than 0.74 mmol/l', 'non-diabetic subjects with insulin resistance', 'non-diabetic subjects']","['magnesium supplementation', 'placebo', 'magnesium chloride (MgCl2', 'MgCl2 2.5 g daily or placebo', 'Oral magnesium supplementation']","['serum magnesium levels', 'insulin sensitivity', 'reduced HOMA-IR index']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1099586', 'cui_str': 'PDMSMgCl'}, {'cui': 'C0024472', 'cui_str': 'Magnesium Chloride'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.540321,At baseline there were not significant anthropometric or laboratory differences between both groups.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guerrero-Romero', 'Affiliation': 'Medical Research Unit in Clinical Epidemiology of the Mexican Social Security Institute, and Research Group on Diabetes and Chronic Illnesses, FACP Siqueiros 225 esq./Castañeda, 34000 Durango, Dgo., Mexico. guerrero_romero@hotmail.com'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Tamez-Perez', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'González-González', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Salinas-Martínez', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Montes-Villarreal', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Treviño-Ortiz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodríguez-Morán', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70116-7']
722,16523185,ICAPS: a multilevel program to improve physical activity in adolescents.,"OBJECTIVES


ICAPS (Intervention Centred on Adolescents' Physical activity and Sedentary behaviour) is aimed at preventing excessive weight gain and cardiovascular risk in adolescents by promoting physical activity (PA) with an emphasis on recreational and daily-life PA, with a lifelong perspective.
DESIGN


Randomized study designed to last for four years. Study cohort constituted of 954 first-level students (91% of eligible pupils), aged 11.7 +/- 0.6 y (mean +/- SD) from four pairs of schools randomly selected in eastern France, after sociogeographical stratification. In each pair, intervention status was randomised at school-level. The program, not limited to school settings, involves multiple partners with three objectives: 1) changing attitudes through debates and access to attractive activities during breaks and after-school hours, 2) encouraging social support, 3) providing environmental conditions that enable PA. Adapted times and places, open participation, emphasis on fun, meeting with others and absence of competitive aspects are used to reduce usual barriers to PA. Accessibility and safety are permanent concerns.
RESULTS


Prevalence of overweight was 23.7%. High participation rates were attained (50% participated in at least one weekly activity). At six-month, the proportion of intervention adolescents not performing supervised PA out of academic PA was reduced by half (36% to 17% vs 42% to 42% in controls P < 10-4); the proportion of those spending > 3 h/day in sedentary occupations decreased (34% to 28% vs 27% to 36%; P < 10-4).
CONCLUSION


These data demonstrate the feasibility of implementing a multilevel PA intervention program in adolescents. Six-month results document increased PA and decreased sedentary behaviour.",2006,"At six-month, the proportion of intervention adolescents not performing supervised PA out of academic PA was reduced by half (36% to 17% vs 42% to 42% in controls P < 10-4); the proportion of those spending > 3 h/day in sedentary occupations decreased (34% to 28% vs 27% to 36%;","['adolescents', 'SD) from four pairs of schools randomly selected in eastern France, after sociogeographical stratification', 'Study cohort constituted of 954 first-level students (91% of eligible pupils), aged 11.7 ']","['multilevel PA intervention program', 'ICAPS']","['sedentary behaviour', 'Prevalence of overweight', 'High participation rates', 'Accessibility and safety', 'academic PA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0145806,"At six-month, the proportion of intervention adolescents not performing supervised PA out of academic PA was reduced by half (36% to 17% vs 42% to 42% in controls P < 10-4); the proportion of those spending > 3 h/day in sedentary occupations decreased (34% to 28% vs 27% to 36%;","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'EA1801 Epidemiology of cardiovascular diseases and cancer, Influence of nutrition and physical inactivity, Université Louis Pasteur, Faculté de Médecine, 67085 Strasbourg Cedex, France. chantal.simon@medecine-u-strasbg.fr'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Platat', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arveiler', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Schweitzer', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Schlienger', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Triby', 'Affiliation': ''}]",Diabetes & metabolism,[]
723,30817270,Can the expression level of PIWIL 2 gene be a serum marker for prostate cancer? A single-center prospective study.,"OBJECTIVE


The aim of the present study was to evaluate the predictive value of the serum expression level of Piwi-like 2 (PIWIL2), a stem cell protein, for prostate cancer (PCa).
MATERIALS AND METHOD


This randomized and prospective study included a total of 60 volunteers between 50 and 75 years old. Cases were assigned to three groups according to prostate-specific antigen (PSA) elevations and pathology reports, with 20 participants in each group. The first group included patients with a PSA level of >4 ng/dL and with PCa, the second group included patients with a PSA level of >4 ng/dL and with benign prostate hyperplasia, and the third group included patients with a PSA level of ≤4 ng/dL and with benign prostate hyperplasia. The levels of serum PSA and PIWIL2 expressions were compared between the groups.
RESULTS


The median serum PSA levels were 28.5 (4.6-98.1) ng/mL, 8.89 (4.3-24.1) ng/mL, and 2.4 (0.3-3.8) ng/mL for groups 1, 2, and 3, respectively. The PSA levels were significantly different between the groups (p<0.001). The median PIWIL2 gene expression levels were 2.54 (0.28-9.27), 2.27 (0.6-9.38), and 1.17 (0.26-3.07) for groups 1, 2, and 3, respectively. The PIWIL2 gene expression level was found to be lower in patients with a PSA level of <4 (p=0.02). No significant difference was observed between patients with and without cancer among those with a PSA level of ≥4 (p>0.05). Patients diagnosed with cancer were grouped according to the criteria of the International Society of Urological Pathology (ISUP), and PIWIL2 gene expression was observed to be significantly higher among patients with ISUP of >3 than among those with ISUP of ≤3 (p=0.04).
CONCLUSION


In our study, it was observed that the serum level of PIWIL2 gene expression could not be a diagnostic indicator of PCa; however, it could be a beneficial prognostic indicator particularly for progressed disease.",2019,The PIWIL2 gene expression level was found to be lower in patients with a PSA level of <4 (p=0.02).,"['patients with a PSA level of >4 ng/dL and with PCa, the second group included patients with a PSA level of >4 ng/dL and with benign prostate hyperplasia, and the third group included patients with a PSA level of ≤4 ng/dL and with benign prostate hyperplasia', '60 volunteers between 50 and 75 years old', 'prostate cancer (PCa', 'Patients diagnosed with cancer']",[],"['PSA levels', 'levels of serum PSA and PIWIL2 expressions', 'median PIWIL2 gene expression levels', 'median serum PSA levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],"[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",60.0,0.0319909,The PIWIL2 gene expression level was found to be lower in patients with a PSA level of <4 (p=0.02).,"[{'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Tosun', 'Affiliation': ""Department of Pediatric Urology, Ankara Children's Health and Disease Hemotology-Oncology Training and Research Hospital, Ankara, Turkey.""}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirtaş', 'Affiliation': 'Department of Urology, Erciyes University School of Medicine, Kayseri, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Sönmez', 'Affiliation': 'Clinic of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Şevket Tolga', 'Initials': 'ŞT', 'LastName': 'Tombul', 'Affiliation': 'Department of Urology, Erciyes University School of Medicine, Kayseri, Turkey.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Akalın', 'Affiliation': 'Department of Medical Genetics, Erciyes University School of Medicine, Kayseri, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Özkul', 'Affiliation': 'Department of Medical Genetics, Erciyes University School of Medicine, Kayseri, Turkey.'}]",Turkish journal of urology,['10.5152/tud.2019.46416']
724,15959425,Electronic pill-boxes in the evaluation of oral hypoglycemic agent compliance.,"OBJECTIVE


To compare compliance in type 2 diabetic patients treated with glimepiride once daily or glibenclamide twice to three times daily.
METHODS


Poorly controlled type 2 diabetic patients aged 35-65 years were randomized to glimepiride 1 mg once daily or to glibenclamide 1.25 mg twice daily. During initial titration, doses ranged from 1 to 6 mg once daily (glimepiride) and from 1.25 mg twice daily to 5 mg 3 times daily (glibenclamide) to achieve fasting blood glucose < 126 mg/dL. The final titration phase doses were continued during the maintenance phase. Both treatments were packed in electronic pill-boxes fitted with a microprocessor to record dates and times of each opening. Compliance was assessed in terms of mean daily compliance (MDC) and the ratio of days with adequate compliance (DAC). Glycemic control was assessed in terms of the adjusted mean final HbA1c, and the incidence of hypoglycemia. Patient satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire.
RESULTS


Compliance over the whole study was generally good, but the MDC was significantly better with glimepiride (87+/-16%) than with glibenclamide (80+/-17%;P < 0.0001). The ratios of DAC for glimepiride and glibenclamide were 87+/-16% and 67+/-24% respectively (P < 0.0001). The adjusted final HbA1c, and the incidence of hypoglycemia were similar in the two groups. Treatment satisfaction on the DTSQc was greater with glimepiride than with glibenclamide (P = 0.0034).
CONCLUSIONS


Patient compliance and treatment satisfaction with once-daily glimepiride were significantly better than with glibenclamide 2 to 3 times daily.",2005,"Treatment satisfaction on the DTSQc was greater with glimepiride than with glibenclamide (P = 0.0034).
","['type 2 diabetic patients treated with', 'Poorly controlled type 2 diabetic patients aged 35-65 years']","['Electronic pill-boxes', 'glibenclamide', 'glimepiride 1 mg once daily or to glibenclamide', 'glimepiride', 'daily (glimepiride', 'glimepiride once daily or glibenclamide', 'glimepiride and glibenclamide']","['MDC', 'ratios of DAC', 'Patient satisfaction', 'mean daily compliance (MDC) and the ratio of days with adequate compliance (DAC', 'incidence of hypoglycemia', 'DTSQc', 'Glycemic control']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0986239', 'cui_str': 'glimepiride 1 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0222955,"Treatment satisfaction on the DTSQc was greater with glimepiride than with glibenclamide (P = 0.0034).
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'Service de médecine interne, endocrinologie et diabétologie, Centre hospitalier Sud Francilien, 91108 Corbeil-Essonnes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fleury', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Dubroca', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vaur', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Clerson', 'Affiliation': ''}]",Diabetes & metabolism,[]
725,30729881,Outcomes of a Problem-Solving Medication Management Intervention for Informal Caregivers.,"Older adults with memory loss often require assistance from caregivers to manage their medications. This study examined the efficacy of a problem-solving-based intervention focused on caregiver medication management, problem solving, self-efficacy, and daily hassles. Caregiver health-related quality of life (HRQoL) and patient health care utilization were secondary outcomes. Totally, 83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5%) were randomized; data collection occurred at baseline, 8, 16, and 24 weeks. Linear mixed modeling showed significant decreases in medication deficiencies which were sustained over time. No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time. In addition, caregiver self-efficacy and mental HRQoL decreased in both groups. Physical HRQoL decreased in the intervention group, yet increased in the usual care group. Future research should investigate these outcomes in larger and more diverse samples.",2019,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","['Older adults with memory loss', 'Informal Caregivers', '83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5']","['problem-solving-based intervention', 'Problem-Solving Medication Management Intervention']","['Physical HRQoL', 'caregiver problem solving, daily hassles, or patient health care utilization', 'caregiver self-efficacy and mental HRQoL', 'medication deficiencies', 'Caregiver health-related quality of life (HRQoL) and patient health care utilization']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751295', 'cui_str': 'Memory Loss'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",83.0,0.037252,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Erlen', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Fengyan', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'University of Pittsburgh, PA, USA.'}]",Western journal of nursing research,['10.1177/0193945919825844']
726,32407655,Methodology Matters: The Impact of Research Design on Conversational Entrainment Outcomes.,"Purpose Conversational entrainment describes the tendency for individuals to alter their communicative behaviors to more closely align with those of their conversation partner. This communication phenomenon has been widely studied, and thus, the methodologies used to examine it are diverse. Here, we summarize key differences in research design and present a test case to examine the effect of methodology on entrainment outcomes. Method Sixty neurotypical adults were randomly assigned to experimental groups formed by a 2 × 2 factorial combination of two independent variables: stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli). Individuals participated in a quasiconversational design in which the speech of a virtual interlocutor was manipulated to produce fast and slow speech rate conditions. Results There was a significant effect of stimuli organization on entrainment outcomes. Individuals in the blocked, but not the random, groups altered their speech rate to align with the speech rate of the virtual interlocutor. There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes. Conclusion Findings highlight the importance of methodological decisions on entrainment outcomes. This underscores the need for more comprehensive research regarding entrainment methodology.",2020,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"['Method Sixty neurotypical adults', 'Methodology Matters']",['stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",[],60.0,0.0260353,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"[{'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Wynn', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Borrie', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00243']
727,31736187,Stress-related suppression of peripheral cytokines predicts future relapse in alcohol-dependent individuals with and without subclinical depression.,"Chronic alcohol abuse and depressive symptoms are both associated with peripheral cytokine changes. Despite this, cytokine adaptations have not been assessed in co-morbid populations or prospectively as predictors of relapse. We examine cytokine responses to stress in alcohol-dependent individuals and social drinkers, both with and without subclinical depression. We also examine the potential link between cytokine adaptations in response to stress and prospective alcohol relapse risk. Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms) were exposed to two 5-minute personalized guided imagery conditions (stress and neutral) across consecutive days in a randomized and counterbalanced order. Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure. Following treatment discharge, follow-up interviews were conducted over 90 days to assess relapse. Dampened IL-1ra and IL-6 in response to stress was observed as a function of alcohol dependence and not moderated by depressive symptoms. Lower levels of IL-6 following stress also predicted greater drinking days following treatment. Conversely, high depressive symptomatology was associated solely with pro-inflammatory adaptations. Stress-related suppression of TNFα predicted drinking severity only in alcohol-dependent individuals with subclinical depression, and suppressed TNFR1 following stress was only seen in individuals with subclinical depression. Stress-induced suppression of pro-inflammatory TNF markers may indicate a risk factor for alcohol-dependent individuals with co-occurring depressive symptoms.",2020,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","['alcohol-dependent individuals with and without subclinical depression', 'Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms', 'alcohol-dependent individuals and social drinkers, both with and without subclinical depression']",['5-minute personalized guided imagery conditions (stress and neutral'],"['Chronic alcohol abuse and depressive symptoms', 'Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}]",,0.0329056,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, School of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'LaVallee', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Simpson', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, The Connecticut Mental Health Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Addiction biology,['10.1111/adb.12832']
728,30777631,Cost Benefit of High-Dose vs Standard-Dose Influenza Vaccine in a Long-Term Care Population During an A/H1N1-Predominant Influenza Season.,"OBJECTIVES


Influenza is a leading cause of avoidable admissions for nursing home (NH) residents. We previously evaluated the effectiveness of a high-dose trivalent influenza vaccine (HD) compared to a standard-dose influenza vaccine (SD) through a cluster-randomized trial of NH residents. Fewer residents from facilities randomized to HD were hospitalized. In this article, we extend our analyses to consider direct medical care costs relative to vaccine costs for HD ($31.82/dose) as compared to SD ($12.04/dose).
DESIGN


Post hoc, cost-benefit analysis.
SETTING AND PARTICIPANTS


From the participating NH facilities (n = 817), we identified Medicare fee-for-service enrollees who were long-stay residents (>100 days) at the start of the 2013-2014 influenza season (November 1-May 31). The intervention was residence in a facility randomized to HD or SD influenza vaccine.
METHODS


We summed expenditures from long-stay NH residents' Medicare Part A, B, and D fee-for-service claims and compared person-level expenditures between residents of facilities offering HD vs SD. Expenditures were adjusted for clustering of residents within NHs, person-time, and prespecified covariates using 2-part, generalized linear models with bootstrapped standard errors. We examined the incremental cost-benefit of HD vs SD vaccines from a payer perspective.
RESULTS


There were 18,605 and 18,658 Medicare fee-for-service long-stay residents in facilities offering HD and SD, respectively. Person- and facility-adjusted total expenditures differed by $546 (P = .006). The $20 incremental cost of HD to SD offset adjusted expenditures for a net benefit of $526 per NH resident and a financial return on investment of 546/20 = 27:1.
CONCLUSIONS/IMPLICATIONS


The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose. These cost offsets applied to Medicare beneficiaries residing in NHs could result in important savings to the Medicare program.",2019,The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose.,"['817', 'There were 18,605 and 18,658 Medicare fee-for-service long-stay residents in facilities offering HD and SD, respectively', 'service enrollees who were long-stay residents (>100\xa0days) at the start of the 2013-2014 influenza season (November 1-May 31', 'nursing home (NH) residents', 'NH residents', 'From the participating NH facilities (n\xa0']","['standard-dose influenza vaccine (SD', 'HD vs SD vaccines', 'high-dose trivalent influenza vaccine (HD', 'High-Dose vs Standard-Dose Influenza Vaccine', 'HD influenza vaccine', 'HD or SD influenza vaccine']","['total health care expenditures', 'Person- and facility-adjusted total expenditures']","[{'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4505396', 'cui_str': 'High-Dose Trivalent Influenza Vaccine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",,0.0473105,The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose.,"[{'ForeName': 'Theresa I', 'Initials': 'TI', 'LastName': 'Shireman', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI. Electronic address: Theresa_Shireman@brown.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ogarek', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gozalo', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI.'}, {'ForeName': 'H Edward', 'Initials': 'HE', 'LastName': 'Davidson', 'Affiliation': 'Insight Therapeutics, LLC, Norfolk, VA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Insight Therapeutics, LLC, Norfolk, VA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Toronto, Ottawa, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gravenstein', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI; Warren Alpert Medical School of Brown University, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.12.003']
729,31900475,Innovative Burn Treatment Using Tilapia Skin as a Xenograft: A Phase II Randomized Controlled Trial.,"Skin substitutes are considered a useful alternative for occlusive dressings in the treatment of superficial burns as they reduce the frequency of dressing replacement. This phase II randomized controlled trial aimed to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive xenograft dressing for the treatment of burn wounds in humans. In order to assess the use of tilapia skin, the following variables were evaluated: number of days for wound healing, the number of times the occlusive dressing was changed, use of anesthetics or analgesics, pain assessment using the Visual Analogue Scale, and evaluation of burn improvement on the day of dressing removal. In total, 62 participants completed the study. It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine. In our study, the tilapia skin xenograft showed good efficacy as an occlusive biological dressing for burn wound treatment in humans.",2020,"It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine.","['humans', 'burn wounds in humans', '62 participants completed the study']","['Innovative Burn Treatment Using Tilapia Skin', 'silver sulfadiazine', 'Nile tilapia (Oreochromis niloticus) skin']","['anesthetics or analgesics, pain assessment using the Visual Analogue Scale, and evaluation of burn improvement', 'necessity of dressing changes', 'pain intensity', 'complete reepithelialization']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162642', 'cui_str': 'Tilapia'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0162641', 'cui_str': 'Oreochromis niloticus'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",62.0,0.0259218,"It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine.","[{'ForeName': 'Edmar Maciel', 'Initials': 'EM', 'LastName': 'Lima Júnior', 'Affiliation': 'Burn Treatment Center, Dr. José Frota Institute, Fortaleza, CE, Brazil.'}, {'ForeName': 'Manoel Odorico', 'Initials': 'MO', 'LastName': 'De Moraes Filho', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Bruno Almeida', 'Initials': 'BA', 'LastName': 'Costa', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Andréa Vieira Pontes', 'Initials': 'AVP', 'LastName': 'Rohleder', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Marina Becker', 'Initials': 'MB', 'LastName': 'Sales Rocha', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Francisco Vagnaldo', 'Initials': 'FV', 'LastName': 'Fechine', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Antonio Jorge', 'Initials': 'AJ', 'LastName': 'Forte', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Ana Paula Negreiros Nunes', 'Initials': 'APNN', 'LastName': 'Alves', 'Affiliation': 'Nursing, Dentistry and Pharmacy School of the Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Francisco Raimundo', 'Initials': 'FR', 'LastName': 'Silva Júnior', 'Affiliation': 'Burn Treatment Center, Dr. José Frota Institute, Fortaleza, CE, Brazil.'}, {'ForeName': 'Camila Barroso', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Mônica Beatriz', 'Initials': 'MB', 'LastName': 'Mathor', 'Affiliation': 'Institute of Nuclear Energy Research-IPEN-CNEN/SP, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Elisabete Amaral de', 'Initials': 'MEA', 'LastName': 'Moraes', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz205']
730,31680746,"Capsulectomy vs capsulotomy in total hip arthroplasty. Clinical outcomes and proprioception evaluation: Study protocol for a randomized, controlled, double blinded trial.","Background


Patients affected by coxarthrosis may be treated surgically with total hip arthroplasty (THA). During the surgical intervention, the hip joint capsule can be completely removed, performing a capsulectomy. Otherwise it's possible to perform a capsulotomy, which allows for capsular conservation. Since there is no scientific evidence demonstrating the superiority of one method over the other, the choice whether to remove or conserve the capsule is at the surgeon's discretion and both procedures are actually accepted.The purpose of our study is to evaluate the differences in functional activities and proprioception in patients who underwent THA and capsulotomy with capsular conservation versus patients who underwent THA with capsulectomy.
Methods


In order to compare the two surgical techniques of capsulotomy with capsular conservation and capsulectomy, we created a randomized, controlled, double-blind, single-centre, non-pharmacological, interventional, superiority, parallel-group trial. The primary outcome of our study is evaluated using the HOOS scale (Hip disability and Osteoarthritis Outcome Score). Secondary outcomes are: the proprioceptive sensitivity, the postoperative bleeding, the surgical time, the active range of motion, and the ability to walk, sit and stand. The proprioception study is carried out through active and passive repositioning tests. THA is performed through the minimally invasive direct anterior approach. The evaluation tests are carried out in the 15 days preceding the intervention (T0), at 50-day post-operative (T1), and finally at three months after surgery (T2).
Discussion


Considering that the hip joint capsule is innervated by proprioceptive nerve endings, while the psuedocapsule that replaces the native capsule following a THA with capsulectomy doesn't have any active neurophysiological role, we hypothesize that capsulotomy with capsular conservation at the time of primary THA may lead to better proprioception and therefore better functional recovery.
Trial registration


ClinicalTrials.gov identifier: NCT02749058. Date of registration: 04/21/2016.",2019,"Secondary outcomes are: the proprioceptive sensitivity, the postoperative bleeding, the surgical time, the active range of motion, and the ability to walk, sit and stand.","['patients who underwent THA and capsulotomy with capsular conservation versus patients who underwent THA with capsulectomy', 'total hip arthroplasty']","['capsulotomy with capsular conservation and capsulectomy', 'THA', 'Capsulectomy vs capsulotomy']","['functional activities and proprioception', 'HOOS scale (Hip disability and Osteoarthritis Outcome Score', 'Clinical outcomes and proprioception evaluation', 'proprioceptive sensitivity, the postoperative bleeding, the surgical time, the active range of motion, and the ability to walk, sit and stand']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0395522', 'cui_str': 'Capsulectomy of lens (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0395522', 'cui_str': 'Capsulectomy of lens (procedure)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0222045'}, {'cui': 'C2960679', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",,0.175861,"Secondary outcomes are: the proprioceptive sensitivity, the postoperative bleeding, the surgical time, the active range of motion, and the ability to walk, sit and stand.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ometti', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Brambilla', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gatti', 'Affiliation': 'Laboratory of Analysis and Rehabilitation of Motor Function, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tettamanti', 'Affiliation': 'Laboratory of Analysis and Rehabilitation of Motor Function, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'La Cava', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Pironti', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Fraschini', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Salini', 'Affiliation': 'Department of Orthopaedics and Traumatology San Raffaele Hospital, Milan, Italy.'}]",Journal of orthopaedics,['10.1016/j.jor.2019.09.020']
731,30772898,Person-Centered Sexual Expression: Determining Preferences of Future Nursing Home Residents.,"BACKGROUND AND OBJECTIVES


Approaches to sexual expression in nursing homes are often devoid of person-centered components, such as resident choice. Little is known about residents' preferences for sexual and intimate expression across different situations. To evaluate future resident preferences, a convenience sample of 389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors).
RESEARCH DESIGN AND METHODS


A randomized experimental vignette design was implemented to determine situational factors that influence future resident preferences for sexual expression in nursing homes. Data were analyzed via multilevel modeling, allowing for multiple vignette ratings to be nested among respondents.
RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities. Also, cognition and relationship levels interacted for more nuanced effects on activity appropriateness.
DISCUSSION AND IMPLICATIONS


Future resident preferences are often incongruent with attitudes and common practices for approaching sexual expression in nursing home settings. This marks a unique opportunity for person-centered policy development and implementation in the realm of sexual expression.",2020,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","['nursing homes', 'Future Nursing Home Residents', '389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors']",[],[],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],[],,0.0293967,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","[{'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Syme', 'Affiliation': 'Center on Aging, Kansas State University, Manhattan.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Johnson', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Fager', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}]",The Gerontologist,['10.1093/geront/gnz016']
732,30762087,Acute reconstruction results in less sick-leave days and as such fewer indirect costs to the individual and society compared to delayed reconstruction for ACL injuries.,"PURPOSE


To compare the total number of sick-leave days caused by the knee injury from the day of injury and over the first year between acute (within 8 days) and delayed (6-10 weeks) anterior cruciate ligament reconstruction (ACLR) and also assess other clinical outcomes during this period.
METHODS


Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8 days) or delayed (after 6-10 weeks) ACLR. Patient-reported outcomes; objective IKDC and manual stability measurements were assessed at 6 and 12 months. With data from the Swedish Social Insurance Agency (Försäkringskassan) information about the number of sick-leave days due to the knee injury over the following 12 months was collected and compared between the two groups.
RESULTS


Seventy-one percent received compensation for sick leave (26 in the acute versus 23 in the delayed group). The mean number of sick-leave days for the acute group was significantly lower (M = 56.9, SD = 36.4) compared to the delayed group (M = 88.5, SD = 50.2), p < 0.05. The acute group was also significantly stronger in flexion in both slow and fast angle velocities according to Biodex ® . No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
CONCLUSION


Acute and delayed ACLR provided comparable clinical outcomes after 12 months. Acute reconstruction resulted in less sick-leave days and as such fewer indirect costs to the individual and society. These findings suggest that if patients requiring ACLR can be identified early and ACLR can be performed in the acute phase, socioeconomic costs can potentially be reduced by minimizing time off work.
LEVEL OF EVIDENCE


II.",2020,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","['With data from the Swedish Social Insurance Agency ', 'Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8\xa0days) or delayed (after 6-10\xa0weeks']",['anterior cruciate ligament reconstruction (ACLR'],"['flexion in both slow and fast angle velocities', 'compensation for sick leave', 'total number of sick-leave days', 'outcomes; objective IKDC and manual stability measurements', 'mean number of sick-leave days']","[{'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.0674861,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'McCallum', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05397-3']
733,31590967,BARI 2D: A Reanalysis Focusing on Cardiovascular Events.,"OBJECTIVE


To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus and stable coronary artery disease.
PATIENTS AND METHODS


From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease were randomly assigned to insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED]), with all patients receiving intensive medical treatment. The outcome of this analysis was a composite of 8 CVD events.
RESULTS


Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8% (95% CI, 33.1%-38.5%) with IS therapy and 41.6% (95% CI, 38.7%-44.5%) with IP therapy (P=.004). Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A 1c  with IS therapy. Four-year composite CVD rates were 32.7% (95% CI, 30.0%-35.4%) with REV and 44.7% (95% CI, 41.8%-47.6%) with MED (P<.001). A beneficial effect of IS vs IP therapy was present with REV (27.7%; 95% CI, 24.0%-31.4% vs 37.5%; 95% CI, 33.6%-41.4%; P<.001), but not with MED (43.6%; 95% CI, 39.5%-47.7% vs 45.7%; 95% CI, 41.6%-49.8%; P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV was limited to participants preselected for coronary artery bypass grafting (CABG). The lowest composite CVD rates occurred in patients preselected for CABG and assigned to IS therapy and REV (17.3%; 95% CI, 11.8%-22.8%).
CONCLUSION


In the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, the IS treatment strategy and the REV treatment strategy each reduces cardiovascular events. The combination of IS drugs and CABG results in the lowest risk of subsequent CVD events.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00006305.",2019,"Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A 1c  with IS therapy.","['participants preselected for coronary artery bypass grafting (CABG', 'patients with type 2 diabetes mellitus and stable coronary artery disease', 'From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease']","['insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED', 'intensive medical treatment']","['composite CVD rates', 'composite CVD outcome', 'BARI 2D', 'cardiovascular events', 'lowest composite CVD rates']","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",2368.0,0.164248,"Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A 1c  with IS therapy.","[{'ForeName': 'Saul M', 'Initials': 'SM', 'LastName': 'Genuth', 'Affiliation': 'Division of Clinical and Molecular Endocrinology, Department of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Vlachos', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, PA.'}, {'ForeName': 'Maria Mori', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, PA. Electronic address: mbrooks@pitt.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis; Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'Division of Cardiology, Department of Medicine, St. Louis University, MO.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sheryl F', 'Initials': 'SF', 'LastName': 'Kelsey', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, PA.'}, {'ForeName': 'Spencer B', 'Initials': 'SB', 'LastName': 'King', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBane', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Edward Y', 'Initials': 'EY', 'LastName': 'Sako', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Vermont Medical Center, Burlington.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Steffes', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis; Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Frye', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2019.04.015']
734,29217375,"Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials.","BACKGROUND


A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings.
METHODS


We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Vaccinations were given intramuscularly on days 1 and 29. The primary objective was safety and immunogenicity of the ZPIV candidate. We recorded adverse events and Zika virus envelope microneutralisation titres up to day 57. These trials are registered at ClinicalTrials.gov, numbers NCT02963909, NCT02952833, and NCT02937233.
FINDINGS


We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017. One was excluded and 67 participants received two injections of Zika vaccine (n=55) or placebo (n=12). The vaccine caused only mild to moderate adverse events. The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]). By day 57, 52 (92%) of vaccine recipients had seroconverted (microneutralisation titre ≥1:10), with peak geometric mean titres seen at day 43 and exceeding protective thresholds seen in animal studies.
INTERPRETATION


The ZPIV candidate was well tolerated and elicited robust neutralising antibody titres in healthy adults.
FUNDING


Departments of the Army and Defense and National Institute of Allergy and Infectious Diseases.",2018,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","['We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017', 'healthy adults', 'human beings']","['placebo', 'purified formalin-inactivated Zika virus vaccine (ZPIV', 'Zika vaccine', 'ZPIV with aluminium hydroxide adjuvant', 'computer-generated list to receive 5 μg ZPIV or saline placebo']","['tenderness', 'adverse events and Zika virus envelope microneutralisation titres', 'malaise', 'headache', 'safety and immunogenicity']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.549153,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","[{'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sondergaard', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tennant', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Kosel', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center and Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Meyer', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brien', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Crowell', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Blazevic', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Mosby', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Larocca', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Bricault', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Basil', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tonwe', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hoft', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.mil@mail.mil.'}]","Lancet (London, England)",['10.1016/S0140-6736(17)33106-9']
735,31696739,Extracranial activation of ATP-sensitive potassium channels induces vasodilation without nociceptive effects.,"INTRODUCTION


Levcromakalim opens ATP-sensitive potassium channels (K ATP  channel) and induces head pain in healthy volunteers and migraine headache in migraine patients, but no pain in other parts of the body. K ATP  channels are expressed in C- and Aδ-fibers, and these channels might directly activate nociceptors and thereby evoke pain in humans.
METHODS


To assess the local effect of K ATP  channel opening in trigeminal and extra-trigeminal regions, we performed a crossover, double-blind, placebo-controlled study in healthy volunteers. Participants received intradermal and intramuscular injections of levcromakalim and placebo in the forehead and the forearms.
RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05). Intradermal injection of levcromakalim caused more flare ( p  < 0.001 ) , skin temperature increase ( p  < 0.001), and skin blood flow increase ( p  < 0.001) compared to placebo in the forehead and the forearms.
CONCLUSION


These findings suggest that it is unlikely that levcromakalim induces head pain by direct activation of peripheral neurons.",2019,"RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05).","['in trigeminal and extra-trigeminal regions', 'healthy volunteers and migraine headache in migraine patients', 'healthy volunteers']","['levcromakalim', 'intradermal and intramuscular injections of levcromakalim and placebo', 'placebo', 'Levcromakalim opens ATP-sensitive potassium channels (K ATP  channel', 'K ATP  channel opening']","['skin blood flow increase', 'pain', 'skin temperature increase ']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0244960', 'cui_str': 'Levcromakalim'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",,0.0650602,"RESULTS


Intradermal and intramuscular injections of levcromakalim did not evoke more pain compared to placebo in the forehead ( p  > 0.05) and the forearms ( p  > 0.05).","[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Aghazadeh', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lene Theil', 'Initials': 'LT', 'LastName': 'Skovgaard', 'Affiliation': 'Department of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888490']
736,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
737,32407608,"Liver function and prognosis, and influence of sacubitril/valsartan in patients with heart failure with reduced ejection fraction.","AIMS


The prevalence of liver function abnormalities is common in patients with heart failure (HF) with reduced ejection fraction (HFrEF). We assessed the impact of liver function on prognosis and the effect of sacubitril/valsartan on measures of liver function in patients with HFrEF.
METHODS AND RESULTS


The PARADIGM-HF trial was a randomized, double-blind, active treatment-controlled trial. We included 8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a composite of HF hospitalization and cardiovascular (CV) death. At screening, 11.6% of study patients had total bilirubin above the upper limit of normal (20.5 μmol/L) and 9.2% had ALP above the upper limit of normal (123 IU/L). Although ALP and albumin were associated with an increased risk of outcomes, among conventional test of liver function, total bilirubin was the strongest predictor for the primary endpoint [hazard ratio (HR) 1.10; 95% confidence interval (CI) 1.04-1.15; P < 0.001], HF hospitalization (HR 1.14; 95% CI 1.07-1.22; P < 0.001); CV death (HR 1.07; 95% CI 1.00-1.14; P = 0.040), and all-cause death (HR 1.08; 95% CI 1.02-1.14; P = 0.009). All conventional measures of liver function were significantly improved in the sacubitril/valsartan group compared with the enalapril group after randomization (between-group reduction: total bilirubin 2.4%, 95% CI 0.7-4.2%, P = 0.007; aspartate aminotransferase 7.9%, 95% CI 6.7-9.0%, P < 0.001; alanine aminotransferase 7.7%; 95% CI 6.2-9.3%, P < 0.001; ALP 5.4%, 95% CI 4.4-6.4%, P < 0.001).
CONCLUSION


Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF. Sacubitril/valsartan improved measures of liver function compared with enalapril.",2020,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"['patients with HFrEF', 'patients with HFrEF enrolled in PARADIGM-HF', 'patients with heart failure with reduced ejection fraction', '8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF']","['enalapril', 'sacubitril/valsartan', 'Sacubitril/valsartan']","['composite of HF hospitalization and cardiovascular (CV) death', 'HF hospitalization', 'total bilirubin', 'Total bilirubin', 'CV death', 'CV death or HF hospitalization and all-cause mortality', 'liver function', 'liver function, total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1285893', 'cui_str': 'Measure of liver'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",8232.0,0.350391,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"[{'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minamisawa', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Zucker', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1853']
738,31513481,Randomized Phase II Trial of Bevacizumab or Temsirolimus in Combination With Chemotherapy for First Relapse Rhabdomyosarcoma: A Report From the Children's Oncology Group.,"PURPOSE


The primary aim of this clinical trial was to prioritize bevacizumab or temsirolimus for additional investigation in rhabdomyosarcoma (RMS) when administered in combination with cytotoxic chemotherapy to patients with RMS in first relapse with unfavorable prognosis.
PATIENTS AND METHODS


Patients were randomly assigned to receive bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles. Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment. The primary end point was event-free survival (EFS). Radiographic response was assessed at 6 weeks. The study had a phase II selection that was design to detect a 15% difference between the two regimens (α = .2; 1-β = 0.8; two sided test).
RESULTS


Eighty-seven of 100 planned patients were enrolled when the trial was closed after the second interim analysis after 46 events occurred in 68 patients with sufficient follow-up. The O'Brien Fleming boundary at this analysis corresponded to a two-sided  P  value of .058 with an observed two-sided  P  value of .003 favoring temsirolimus. The 6-month EFS for the bevacizumab arm was 54.6% (95% CI, 39.8% to 69.3%) and 69.1% (95% CI, 55.1% to 83%) for the temsirolimus arm. Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
CONCLUSION


Patients who received temsirolimus had a superior EFS compared with bevacizumab. Temsirolimus has been selected for additional investigation in newly diagnosed patients with intermediate-risk RMS.",2019,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","['Patients', 'patients with RMS in first relapse with unfavorable prognosis', 'newly diagnosed patients with intermediate-risk RMS', 'First Relapse Rhabdomyosarcoma', 'Eighty-seven of 100 planned patients', 'rhabdomyosarcoma (RMS']","['cyclophosphamide', 'cytotoxic chemotherapy', 'prioritize bevacizumab', 'vinorelbine', 'Bevacizumab or Temsirolimus', 'bevacizumab', 'Local tumor control with surgery and/or radiation therapy']","['Objective response rates', 'Radiographic response', 'event-free survival (EFS', 'progressive disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.121834,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Hingorani', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck Research Laboratories: Oncology, North Wales, PA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Lyden', 'Affiliation': 'University of Nebraska College of Medicine, Omaha, NE.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'East Carolina University, Greenville, NC.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Indelicato', 'Affiliation': 'University of Florida, Jacksonville, FL.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': 'University of Washington, Seattle, WA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00576']
739,30219394,Systolic Stretch Characterizes the Electromechanical Substrate Responsive to Cardiac Resynchronization Therapy.,"OBJECTIVES


In this study, the authors tested the hypotheses that the systolic stretch index (SSI) developed by computer modeling and applied using echocardiographic strain imaging may characterize the electromechanical substrate predictive of outcome following cardiac resynchronization therapy (CRT). They included patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists. They further tested the hypothesis that global longitudinal strain (GLS) has additional prognostic value.
BACKGROUND


Response to CRT is variable. Guidelines favor patient selection by electrocardiographic LBBB with QRS width ≥150 ms.
METHODS


The authors studied 442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction ≤35%, and QRS ≥120 ms. A novel computer program semiautomatically calculated the SSI from strain curves as the sum of posterolateral prestretch percent before aortic valve opening and the septal rebound stretch percent during ejection. The primary endpoint was hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after CRT.
RESULTS


In all patients, high longitudinal SSI (≥ group median of 3.1%) was significantly associated with freedom from the primary endpoint of HF hospitalization or death (hazard ratio [HR] for low SSI: 2.17; 95% confidence interval [CI]: 1.45 to 3.24, p < 0.001) and secondary endpoint of death (HR for low SSI: 4.06; 95% CI: 1.95 to 8.45, p < 0.001). Among the 203 patients with QRS 120 to 149 ms or non-LBBB, those with high longitudinal SSI (≥ group median of 2.6%) had significantly fewer HF hospitalizations or deaths (HR for low SSI: 2.08; 95% CI: 1.27 to 3.41, p = 0.004) and longer survival (HR for low SSI: 5.08; 95% CI: 1.94 to 13.31, p < 0.001), similar to patients with LBBB ≥150 ms. SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
CONCLUSIONS


Systolic stretch by strain imaging characterized the myocardial substrate associated with favorable CRT response, including in the important patient subgroup with QRS width 120 to 149 ms or non-LBBB. GLS had additive prognostic value.",2019,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","['442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction\xa0≤35%, and QRS\xa0≥120 ms', 'patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists', '203 patients with QRS']",['cardiac resynchronization therapy (CRT'],"['secondary endpoint of death', 'HF hospitalization or death', 'HF hospitalizations or deaths', 'hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after\xa0CRT', 'systolic stretch index (SSI', 'longer survival', 'Systolic stretch']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0006384', 'cui_str': 'Bundle-Branch Block'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",442.0,0.0799423,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gorcsan', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri. Electronic address: gorcsan@wustl.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Anderson', 'Affiliation': 'Biostatistics Group, Medtronic Incorporated, Minneapolis, Minnesota.'}, {'ForeName': 'Bhupendar', 'Initials': 'B', 'LastName': 'Tayal', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sugahara', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walmsley', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Lumens', 'Affiliation': ""CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands; L'Institut de Rythmologie et Modélisation Cardiaque (IHU-LIRYC), Université de Bordeaux, Pessac, France.""}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2018.07.013']
740,31684759,Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil.,"OBJECTIVE


Migraine displays clinical heterogeneity of attack features and attack triggers. The question is whether this heterogeneity is explained by distinct intracellular signaling pathways leading to attacks with distinct clinical features. One well-known migraine-inducing pathway is mediated by cyclic adenosine monophosphate and another by cyclic guanosine monophosphate. Calcitonin gene-related peptide triggers migraine via the cyclic adenosine monophosphate pathway and sildenafil via the cyclic guanosine monophosphate pathway. To date, no studies have examined whether migraine induction mediated via the cyclic adenosine monophosphate and cyclic guanosine monophosphate pathways yields similar attacks within the same patients.
METHODS


Patients were subjected to migraine induction on two separate days using calcitonin gene-related peptide (1.5 µg/min for 20 minutes) and sildenafil (100 mg) in a double-blind, randomized, double-dummy, cross-over design. Data on headache intensity, characteristics and accompanying symptoms were collected until 24 hours after drug administration.
RESULTS


Thirty-four patients were enrolled and 27 completed both study days. Seventeen patients developed migraine after both study drugs (63%; 95% CI: 42-81). Eight patients developed migraine on one day only (seven after sildenafil and one after calcitonin gene-related peptide). Two patients did not develop migraine on either day. Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
CONCLUSION


A majority of patients developed migraine after both calcitonin gene-related peptide and sildenafil. This supports the hypothesis that the cyclic adenosine monophosphate and cyclic guanosine monophosphate intracellular signaling pathways in migraine induction converge in a common cellular determinator, which ultimately triggers the same attacks.  Trial registration:  ClinicalTrials.gov Identifier: NCT03143465.",2019,"Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
","['Thirty-four patients were enrolled and 27 completed both study days', 'Patients were subjected to migraine induction on two separate days using']","['Calcitonin', 'calcitonin gene-related peptide (1.5\u2009µg/min for 20 minutes) and sildenafil', 'sildenafil', 'calcitonin gene-related peptide and sildenafil']","['migraine', 'Headache laterality, nausea, photophobia and phonophobia', 'headache intensity, characteristics and accompanying symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",34.0,0.145985,"Headache laterality, nausea, photophobia and phonophobia were similar between drugs in 77%, 65%, 100%, and 94%, respectively, of the 17 patients who developed attacks on both days.
","[{'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Nikolaj M', 'Initials': 'NM', 'LastName': 'Toft', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Søborg', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419882474']
741,31687738,Hookah is the enemy of health campaign: a campaign for prevention of hookah smoking among youth.,"Hookah smoking is now a serious health threat especially for adolescents. Implementation of planned interventions can help reduce hookah smoking. This study was conducted to investigate the effect of a campaign Hookah is the Enemy of Health Campaign (HEHC) based on the protection motivation theory to prevent hookah smoking among the youth in Sirjan city, in 2018. This was a pre- and post-intervention study. Participants were 280 male and female youth who were selected randomly through the health centers of Sirjan. The educational campaign was conducted during 3 months and participants were trained through interpersonal, group, organizational and community channels and mass media. Data were collected by filling out a questionnaire (containing 64 questions) by the participant before the intervention and 3 months after. Data were analyzed by descriptive statistics (frequency and percentage), chi-square and Wilcoxon signed-rank test by SPSS20 software. The prevalence of hookah smoking was 44.3% in the target group. There was a significant change in the mean scores of knowledge and perceived susceptibility, perceived severity, response efficiency, self-efficacy, rewards, fear and protection motivation after the HEHC (p < 0.05), but there was no significant difference in the structure of perceived cost (p > 0.05). Also, the prevalence of hookah smoking among the target group for those who had ever consumed decreased from 8.9 to 4% and for those who used it occasionally decreased from 35 to 19.4%. The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.",2020,"The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.","['hookah smoking among the youth in Sirjan city, in 2018', 'Participants were 280 male and female youth who were selected randomly through the health centers of Sirjan']","['campaign Hookah', 'HEHC']","['hookah smoking', 'structure of perceived cost', 'prevalence of hookah smoking', 'mean scores of knowledge and perceived susceptibility, perceived severity, response efficiency, self-efficacy, rewards, fear and protection motivation after the HEHC']","[{'cui': 'C4046008', 'cui_str': 'Hookah Smoking'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}]","[{'cui': 'C4046008', 'cui_str': 'Hookah Smoking'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",280.0,0.0207426,"The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Health Education & Promotion, Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Mazloomy Mahmoodabad', 'Affiliation': 'Department of Health Education & Promotion, Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Departments of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rezaeian', 'Affiliation': 'Epidemiology and Biostatistics Department, Occupational Environmental Research Center, Rafsanjan Medical School, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bidaki', 'Affiliation': 'Research Center of Addiction and Behavioral Sciences, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Khanjani', 'Affiliation': 'Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Health promotion international,['10.1093/heapro/daz109']
742,30399021,Serum Concentrations of Lidocaine During Bariatric Surgery.,"Lidocaine has been shown to be clinically beneficial during bariatric surgery. However, information about lidocaine serum concentrations in this setting is scarce. This prospective clinical trial included 42 obese patients undergoing laparoscopic bariatric surgery. They received lidocaine based on adjusted body weight. Administration began with a 1.5 mg·kg bolus of intravenous lidocaine followed by a continuous infusion of 2 mg·kg·hour. After skin closure, administration was decreased to 1 mg·kg·hour until discharge from the recovery room. No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).",2020,No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).,['42 obese patients undergoing'],"['lidocaine', 'laparoscopic bariatric surgery', 'Lidocaine']","['serum concentrations', 'Serum Concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",42.0,0.0631588,No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).,"[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Carabalona', 'Affiliation': 'From the *Département d\'Anesthésie-Réanimation, Groupement Hospitalier Édouard Herriot, Hospices Civils de Lyon, Lyon, France †Equipe d\'Accueil 7426 ""Pathophysiology of Injury-Induced Immunosuppression"" Hospices Civils de Lyon - bioMérieux - Université Claude Bernard Lyon 1, Lyon, France ‡Pôle de Santé publique, Hospices Civils de Lyon, F-69003 Lyon, France §Health Services and Performance Research Laboratory, HEalth Services and PERformance Research Equipe d\'Accueil 7425, Université Claude Bernard Lyon 1, F-69008 Lyon, France ‖Laboratoire de Biologie Médicale Multi Sites du Centre Hospitalo-Universitaire de Lyon, unité de Pharmacologie, Toxicologie et Eléments trace, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon, Lyon, France ¶Laboratoire de Biologie Médicale Multi Sites du Centre Hospitalo-Universitaire de Lyon, unité de Pharmacologie, Toxicologie et Eléments trace, Groupement Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Delwarde', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': ''}, {'ForeName': 'Mary-Charlotte', 'Initials': 'MC', 'LastName': 'Le Goff', 'Affiliation': ''}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Moulsma', 'Affiliation': ''}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Citterio-Quentin', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bouffard', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003905']
743,24788028,Characteristics of community mental health clinics associated with treatment engagement.,"OBJECTIVES


Past literature documents many individual predictors of treatment engagement among mental health clients in community settings, but few studies have examined clinic characteristics that may be associated with treatment engagement. With data from a patient activation and self-management trial, this study examined the variation in demographic and clinic characteristics across community mental health clinics and whether this variation predicted differences in treatment engagement in mental health services.
METHODS


Chart reviews were conducted for 638 clients of 12 community mental health clinics. Client attendance records were collected for a one-year period to examine engagement (defined as the ratio of kept versus scheduled appointments). Adjusting for client variability, the investigators examined which clinic-level characteristics were associated with treatment engagement.
RESULTS


Clinics varied significantly in their clients' demographic characteristics and engagement in mental health care. Providing case management and offering transportation vouchers or free parking at the clinic were associated with lower engagement. However, offering outreach was associated with greater engagement.
CONCLUSIONS


The results of this study suggest that certain clinic characteristics are associated with engagement in mental health services. These results demonstrate the difficulties faced by community mental health clinics in reducing no-show rates even in the face of strong efforts to improve engagement.",2014,These results demonstrate the difficulties faced by community mental health clinics in reducing no-show rates even in the face of strong efforts to improve engagement.,"['638 clients of 12 community mental health clinics', 'mental health clients in community settings']",[],[],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],[],638.0,0.0311648,These results demonstrate the difficulties faced by community mental health clinics in reducing no-show rates even in the face of strong efforts to improve engagement.,"[{'ForeName': 'Gabriela L', 'Initials': 'GL', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Catherine S N', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Dea', 'Initials': 'D', 'LastName': 'Papajorgji-Taylor', 'Affiliation': ''}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Carson', 'Affiliation': ''}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': ''}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201300231']
744,31666651,Effects of attachment-based compassion therapy (ABCT) on brain-derived neurotrophic factor and low-grade inflammation among fibromyalgia patients: A randomized controlled trial.,"Fibromyalgia (FM) is a disabling syndrome characterized by chronic pain associated with fatigue. Its pathogenesis is unknown, but alterations in central sensitization, involving an imbalance of brain-derived neurotrophic factor (BDNF) and inflammatory biomarkers, appear to be implicated. The aim of this study was to evaluate the impact of attachment-based compassion therapy (ABCT) on levels of BDNF, the inflammatory markers TNF-α, IL-6, IL-10, and the C-reactive protein (CRP), analysing whether biomarkers play a mediating/moderating role in improvements in FM functional status. Thirty-four female patients with FM participated in a RCT and were assigned to ABCT or relaxation therapy. Blood extractions were conducted at baseline and post-intervention, with self-report assessments of functional status (FIQ) at baseline, post-intervention and 3-month follow-up. A pro-inflammatory composite was obtained by summing up IL-6, TNF-α and CRP normalized values. Non-parametric tests, analysis of variance and regression models were used to evaluate treatment and mediation/moderation. Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite. Changes in BDNF had a mediating role in FIQ. ABCT seems to reduce BDNF and appears to have anti-inflammatory effects in FM patients. Reductions in BDNF could be a mechanism of FM functional status improvement.Clinical Trial Registration: http://ClinicalTrials.gov , identifier NCT02454244. Date: May 27th, 2015.",2019,"Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite.","['Thirty-four female patients with FM participated in a', 'fibromyalgia patients']","['RCT', 'ABCT', 'attachment-based compassion therapy (ABCT', 'ABCT or relaxation therapy']","['BDNF, CRP, and pro-inflammatory composite', 'levels of BDNF, the inflammatory markers TNF-α, IL-6, IL-10, and the C-reactive protein (CRP', 'FIQ']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",34.0,0.126247,"Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite.","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain. jmonteromarin@hotmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrés-Rodríguez', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Tops', 'Affiliation': 'Department of Clinical, Neuro & Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain. maytenavarrogil@gmail.com.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-019-52260-z']
745,30487209,Effects of short-term continuous positive airway pressure withdrawal on cerebral vascular reactivity measured by blood oxygen level-dependent magnetic resonance imaging in obstructive sleep apnoea: a randomised controlled trial.,"Impaired cerebral vascular reactivity (CVR) increases long-term stroke risk. Obstructive sleep apnoea (OSA) is associated with peripheral vascular dysfunction and vascular events. The aim of this trial was to evaluate the effect of continuous positive airway pressure (CPAP) withdrawal on CVR.41 OSA patients (88% male, mean age 57±10 years) were randomised to either subtherapeutic or continuation of therapeutic CPAP. At baseline and after 2 weeks, patients underwent a sleep study and magnetic resonance imaging (MRI). CVR was estimated by quantifying the blood oxygen level-dependent (BOLD) MRI response to breathing stimuli.OSA did recur in the subtherapeutic CPAP group (mean treatment effect apnoea-hypopnoea index +38.0 events·h -1 , 95% CI 24.2-52.0; p<0.001) but remained controlled in the therapeutic group. Although there was a significant increase in blood pressure upon CPAP withdrawal (mean treatment effect +9.37 mmHg, 95% CI 1.36-17.39; p=0.023), there was no significant effect of CPAP withdrawal on CVR assessed  via  BOLD MRI under either hyperoxic or hypercapnic conditions.Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA. We thus conclude that, unlike peripheral endothelial function, CVR is not affected by short-term CPAP withdrawal.",2019,"Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA.","['obstructive sleep apnoea', 'CVR.41 OSA patients (88% male, mean age 57±10\u2005years']","['subtherapeutic CPAP', 'subtherapeutic or continuation of therapeutic CPAP', 'blood oxygen level-dependent magnetic resonance imaging', 'continuous positive airway pressure (CPAP) withdrawal', 'magnetic resonance imaging (MRI', 'short-term continuous positive airway pressure withdrawal']","['CVR', 'blood pressure upon CPAP withdrawal', 'Impaired cerebral vascular reactivity (CVR) increases long-term stroke risk', 'blood oxygen level-dependent (BOLD) MRI response to breathing stimuli', 'cerebral vascular reactivity', 'Obstructive sleep apnoea (OSA', 'OSA']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.264486,"Short-term CPAP withdrawal did not result in statistically significant changes in CVR as assessed by functional MRI, despite the recurrence of OSA.","[{'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Lettau', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Protazy', 'Initials': 'P', 'LastName': 'Rejmer', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Haile', 'Affiliation': 'Dept of Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Esther I', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Stöberl', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boss', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Anton S', 'Initials': 'AS', 'LastName': 'Becker', 'Affiliation': 'Dept of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Winklhofer', 'Affiliation': 'Dept of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust and University of Oxford, Oxford, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Dept of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}]",The European respiratory journal,['10.1183/13993003.01854-2018']
746,30282699,Impact of Gastric Banding Versus Metformin on β-Cell Function in Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes.,"OBJECTIVE


Type 2 diabetes (T2D) results from progressive loss of β-cell function. The BetaFat study compared gastric banding and metformin for their impact on β-cell function in adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D.
RESEARCH DESIGN AND METHODS


Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year, were randomized to gastric banding or metformin for 2 years. Hyperglycemic clamps (11.1 mmol/L) followed by arginine injection at maximally potentiating glycemia (>25 mmol/L) were performed at baseline, 12 months, and 24 months to measure steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I).
RESULTS


At 24 months, the band group lost 10.7 kg; the metformin group lost 1.7 kg ( P  < 0.01). Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups). SSCP adjusted for insulin sensitivity fell slightly but not significantly in each group ( P  = 0.34 between groups). ACPRmax adjusted for insulin sensitivity fell significantly in the metformin group ( P  = 0.002) but not in the band group ( P  = 0.25 between groups). HbA 1c  fell at 12 and 24 months in the band group ( P  < 0.004) but only at 12 months ( P  < 0.01) in the metformin group ( P  > 0.14 between groups). Normoglycemia was present in 22% and 15% of band and metformin groups, respectively, at 24 months ( P  = 0.66 between groups).
CONCLUSIONS


Gastric banding and metformin had similar effects to preserve β-cell function and stabilize or improve glycemia over a 2-year period in moderately obese adults with IGT or recently diagnosed, mild T2D.",2018,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"['moderately obese adults with IGT or recently diagnosed, mild T2D', 'adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D', 'Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes', 'Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year']","['metformin', 'Gastric Banding Versus Metformin', 'Gastric banding and metformin', 'Hyperglycemic clamps', 'gastric banding or metformin', 'gastric banding and metformin']","['steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I', 'β-cell function', 'HbA 1c  fell', 'SSCP adjusted for insulin sensitivity fell', 'ACPRmax adjusted for insulin sensitivity fell', 'Normoglycemia', 'β-Cell Function', 'Insulin sensitivity', 'β-cell function and stabilize or improve glycemia']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band (procedure)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0243031', 'cui_str': 'SSCP'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",88.0,0.0382476,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"[{'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA buchanan@usc.edu anny.h.xiang@kp.org.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Trigo', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Namir', 'Initials': 'N', 'LastName': 'Katkhouda', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chow', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Cortney', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Krishna S', 'Initials': 'KS', 'LastName': 'Nayak', 'Affiliation': 'Ming Hsieh Department of Electrical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Hendee', 'Affiliation': 'Division of Endocrinology, Clinical Nutrition and Metabolism, Department of Internal Medicine, University of Nevada Reno School of Medicine, Reno, NV.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-1662']
747,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
748,30676350,Postoperative Myocardial Injury in Middle-Aged and Elderly Patients Following Curative Resection of Esophageal Cancer With Aggressive or Standard Body Temperature Management: A Randomized Controlled Trial.,"BACKGROUND


Risk of intraoperative hypothermia is relatively high in middle-aged and elderly patients undergoing curative resection of esophageal cancer, which may cause myocardial ischemia during the early postoperative period. The objective of this study was to compare aggressive or standard body temperature management for lowering the incidence of postoperative myocardial injury that was assessed by troponin levels collected at a priori defined set times in these patients.
METHODS


Seventy patients undergoing elective curative resection of esophageal cancer were randomly assigned to undergo aggressive body temperature management (nasopharyngeal temperature ≥36°C) or standard body temperature management (n = 35 in each arm). The primary outcome was myocardial injury, defined as the occurrence of elevated troponin I (>0.06 µg/L) or elevated high-sensitivity troponin T (≥0.065, or 0.02 µg/L≤ high-sensitivity troponin T <0.065 µg/L, but with an absolute change of at least 0.005 µg/L) or both during 2 days after surgery. Secondary outcomes included (1) severe arrhythmia, including atrial fibrillation, supraventricular tachycardia, frequent premature ventricular contractions intraoperatively or during 3 days postoperatively; (2) hypoxemia or metabolic acidosis during the first 12 h postoperatively; and (3) deep vein thrombosis or pulmonary embolism during 3 days postoperatively.
RESULTS


Incidence of postoperative 2-day myocardial injury was 8.6% (3/35) among patients receiving aggressive body temperature management and 31.4% (11/35) among patients receiving standard body temperature management (P = .017, χ). Relative risk of myocardial injury in the aggressive body temperature management group was 0.27 (95% CI, 0.08-0.89). Incidence of intra- and postoperative 3-day severe cardiac arrhythmia was 2.9% (1/35) among patients receiving aggressive body temperature management and 28.6% (10/35) among patients receiving standard body temperature management. Incidence of postoperative 12-h hypoxia was 17.1% (6/35) with aggressive body temperature management and 40.0% (14/35) with standard body temperature management. Incidence of postoperative 12-h metabolic acidosis was 20% (7/35) among patients receiving aggressive body temperature management and 48.6% (17/35) among patients receiving standard body temperature management. Incidence of postoperative 3-day deep vein thrombosis or pulmonary embolism was 0% (0/35) with aggressive body temperature management and 2.9% (1/35) with standard body temperature management.
CONCLUSIONS


Aggressive body temperature management may be associated with a lower incidence of postoperative myocardial injury.",2019,Incidence of postoperative 12-h metabolic acidosis was 20% (7/35) among patients receiving aggressive body temperature management and 48.6% (17/35) among patients receiving standard body temperature management.,"['Middle-Aged and Elderly Patients Following Curative Resection of Esophageal Cancer With Aggressive or Standard Body Temperature Management', 'middle-aged and elderly patients undergoing curative resection of esophageal cancer', 'Seventy patients undergoing elective curative resection of esophageal cancer']","['aggressive body temperature management (nasopharyngeal temperature ≥36°C) or standard body temperature management', 'intraoperative hypothermia']","['Incidence of postoperative 12-h metabolic acidosis', 'Relative risk of myocardial injury', 'myocardial injury, defined as the occurrence of elevated troponin', 'Postoperative Myocardial Injury', 'Incidence of intra- and postoperative 3-day severe cardiac arrhythmia', 'postoperative 2-day myocardial injury', '1) severe arrhythmia, including atrial fibrillation, supraventricular tachycardia, frequent premature ventricular contractions intraoperatively or during 3 days postoperatively; (2) hypoxemia or metabolic acidosis during the first 12 h postoperatively; and (3) deep vein thrombosis or pulmonary embolism', 'Incidence of postoperative 12-h hypoxia', 'elevated high-sensitivity troponin T', 'Incidence of postoperative 3-day deep vein thrombosis or pulmonary embolism']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C3697005', 'cui_str': 'Core body temperature measured in nasopharynx (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0151636', 'cui_str': 'Ventricular Ectopic Beats'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",70.0,0.097226,Incidence of postoperative 12-h metabolic acidosis was 20% (7/35) among patients receiving aggressive body temperature management and 48.6% (17/35) among patients receiving standard body temperature management.,"[{'ForeName': 'Zuojing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004022']
749,29393137,Uric Acid and Diabetic Nephropathy Risk.,"BACKGROUND


Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD) in the western world. Current treatment methods, with better control of glycemia and blood pressure, including renin-angiotensin system blockade (RASB), appear to have slowed the DN progression rate but have not substantially decreased the annual incidence of new DN ESRD cases. Thus, new treatment targets are needed.
SUMMARY


Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes. Also, UA is a strong predictor of DN progression. Two small, short-term, proof-of-concept clinical trials in which a minority of the patients had diabetes suggested that reduction of UA with allopurinol could decrease the rate of glomerular filtration rate (GFR) loss in persons with chronic kidney disease (CKD). However, a definitive trial to check whether UA reduction can benefit DN progression has not been conducted as yet. Preventing Early Renal Loss in Diabetes (PERL) is an ongoing trial in persons with type 1 diabetes and early to moderate GFR reduction. This 3-year randomized placebo controlled trial in 530 subjects is to check whether UA reduction with allopurinol can slow the rate of GFR decline as determined by the plasma disappearance of iohexol. Key Message: If the results of the PERL trial are positive, initiation of UA reduction treatment while GFR is relatively well preserved could delay ESRD in DN by 8-10 years, that is, considerably longer than the period that has been demonstrated for RASB. This could have important implications for the treatment of DN in particular and of CKD in general.",2018,Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes.,"['530 subjects', 'persons with types 1 and 2 diabetes', 'persons with type 1 diabetes and early to moderate GFR reduction', 'persons with chronic kidney disease (CKD']","['allopurinol', 'placebo']","['glycemia and blood pressure, including renin-angiotensin system blockade (RASB', 'glomerular filtration rate (GFR) loss', 'serum uric acid (UA', 'Uric Acid and Diabetic Nephropathy Risk', 'plasma disappearance of iohexol']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035096'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}]",530.0,0.0408939,Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': ''}]",Contributions to nephrology,['10.1159/000484284']
750,30696387,Exercise-Induced Alterations in Sympathetic-Somatomotor Coupling in Incomplete Spinal Cord Injury.,"The aim of this study was to understand how high- and low-intensity locomotor training (LT) affects sympathetic-somatomotor (SS) coupling in people with incomplete spinal cord injury (SCI). Proper coupling between sympathetic and somatomotor systems allows controlled regulation of cardiovascular responses to exercise. In people with SCI, altered connectivity between descending pathways and spinal segments impairs sympathetic and somatomotor coordination, which may have deleterious effects during exercise and limit rehabilitation outcomes. We postulated that high-intensity LT, which repeatedly engages SS systems, would alter SS coupling. Thirteen individuals (50 ± 7.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a locomotor treadmill training program. Patients were randomized into either a high-intensity (high-LT; 70-85% of maximum predicted heart rate;  n  = 6) group or a low-intensity (low-LT; 50-65% of maximum predicted heart rate;  n  = 7) group and completed up to 20 LT training sessions over 4-6 weeks, 3-5 days/week. Before and after taining, we tested SS coupling by eliciting reflexive sympathetic activity through a cold stimulation, noxious stimulation, and a mental math task while we measured tendon reflexes, blood pressure, and heart rate. Participants who completed high- versus low-LT exhibited significant decreases in reflex torques during triggered sympathetic activity (cold: -83 vs. 13%,  p  < 0.01; pain: -65 vs. 54%,  p  < 0.05; mental math: -43 vs. 41%;  p  < 0.05). Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant. These results suggest that high-LT may be advantageous to low-LT to improve SS coupling in people with incomplete SCI.",2019,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","['people with incomplete spinal cord injury (SCI', 'Thirteen individuals (50\u2009±\u20097.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a']","['locomotor treadmill training program', 'high- and low-intensity locomotor training (LT']","['tendon reflexes, blood pressure, and heart rate', 'reflex torques during triggered sympathetic activity', 'Mean arterial pressure responses to sympathetic stimuli', 'mental math']","[{'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4720884', 'cui_str': 'American Spinal Injury Association impairment scale (assessment scale)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}]","[{'cui': 'C0034943', 'cui_str': 'Reflex, Tendon'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0799656,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Onushko', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brazg', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}]",Journal of neurotrauma,['10.1089/neu.2018.5719']
751,31790144,Dynamic Interactions Between LH and Testosterone in Healthy Community-Dwelling Men: Impact of Age and Body Composition.,"BACKGROUND


Aging is associated with diminished testosterone (Te) secretion, which may be attributed to Leydig cell dysfunction, decreased pituitary stimulation, and altered Te feedback.
OBJECTIVE


To study all regulatory nodes-gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and Leydig cell-in the same cohort of healthy men.
STUDY DESIGN


This was a placebo-controlled, blinded, prospectively randomized cross-over study in 40 men, age range 19 to 73 years, and body mass index (BMI) range 20 to 34.3 kg/m2. A submaximal dose of the GnRH antagonist ganirelix was used to assess outflow of GnRH, by calculating the difference between LH output during the control arm and ganirelix arm. Ketoconazole (a steroidogenic inhibitor) was used to estimate feedback, by the difference in LH output during the ketoconazole and control arm. High-dose ganirelix and repeated LH infusions were used to measure testicular responsivity. Blood sampling was performed at 10-minute intervals.
RESULTS


There were age-related, but not body composition-related decreases in estimated GnRH secretion, the feedback strength of Te on LH, and Leydig cell responsivity to LH, accompanied by changes in approximate entropy. Bioavailable Te levels were negatively related to both age and computed tomography (CT)-estimated abdominal visceral mass (AVF), without interaction between these variables. The LH response to a submaximal dose of GnRH was independent of age and AVF.
CONCLUSION


Advancing age is associated with (1) attenuated bioavailable Te secretion caused by diminished GnRH outflow and not by decreased GnRH responsivity of the gonadotrope, (2) diminished testicular responsivity to infused LH pulses, and (3) partial compensation by diminished Te feedback on central gonadotropic regulation.",2020,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","['Healthy Community-Dwelling Men', 'age range 19-73 yr, BMI range 20-34.3 kg/m2', 'healthy men', '40 men']","['placebo', 'Ketoconazole (steroidogenic inhibitor', 'LH and Testosterone', 'ketoconazole', 'ganirelix (GnRH antagonist']","['LH output', 'Bioavailable Te levels', 'LH response', 'testicular responsivity']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0686114,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology and Metabolism, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz246']
752,30887927,"Dietary Adherence, Self-Efficacy, and Health Behavior Change of WASHOKU-Modified DASH Diet: A Sub-analysis of the DASH-JUMP Study.","BACKGROUND


We previously reported the nutritional characteristics and effects of the DASH-JUMP diet, which is a WASHOKU-modified DASH diet, in Japanese participants with untreated high-normal blood pressure or stage 1 hypertension. The dietary adherence of the DASH diet in Japanese participants has never been evaluated before.
OBJECTIVE


We aimed to assess the relationships between dietary adherence, self-efficacy, and health behavior change among study participants who received the DASH-JUMP diet by home delivery.
METHODS


Participants were treated with the DASH-JUMP diet for 2 months and consumed their usual diets for the next 4 months. We conducted surveys using the stage of behavior change model questionnaire and the modified perceived health competence scale Japanese version questionnaire at baseline and 1, 2, 3, and 6 months to assess dietary adherence.
RESULTS


Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years) returned completed questionnaires, which we analyzed. Health behavior change was motivated by previous behavioral changes and improved biomarkers. The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy. The experience of the DASH-JUMP study for participants included three processes to improve lifestyle habits: Phase 1, reflecting on previous lifestyle habits; Phase 2, learning through new experiences and the acquisition of knowledge; and Phase 3, desiring to maintain their own health.
CONCLUSION


It indicated that the DASH-JUMP diet significantly increased self-efficacy and promoted health behavior change.",2020,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"['Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years', 'Japanese participants with untreated high-normal blood pressure or stage 1 hypertension', 'Japanese participants', 'Participants were treated with the', 'study participants who received the DASH-JUMP diet by home delivery']","['DASH-JUMP diet', 'modified DASH Diet', 'DASH diet']","['health behavior change and previous self-efficacy', 'improvement and maintenance of self-efficacy', 'health competence scale Japanese version questionnaire', 'Dietary Adherence, Self-Efficacy, and Health Behavior Change', 'self-efficacy and promoted health behavior change', 'dietary adherence, self-efficacy, and health behavior change']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.019028,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Inagaki', 'Affiliation': 'Faculty of Nursing Science, Yamanashi Prefectural University, Kouhu, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Umemoto', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kajiya', 'Affiliation': 'Department of Food Science and Biotechnology, Faculty of Agriculture, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kishi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mitarai', 'Affiliation': 'Central Research Institute, Maruha Nichiro Corporation, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Current hypertension reviews,['10.2174/1573402115666190318125006']
753,28941361,Hepatitis C virus testing for case identification in persons born during 1945-1965: Results from three randomized controlled trials.,"The Centers for Disease Control and Prevention and US Preventive Services Task Force recommend one-time hepatitis C virus (HCV) testing for persons born during 1945-1965 (birth cohort). However, few studies estimate the effect of birth cohort (BC) testing implementation on HCV diagnoses in primary care settings. We aimed to determine the probability of identifying HCV infections in primary care using targeted BC testing compared with usual care at three academic medical centers. From December 2012 to March 2014, each center compared one of three distinct interventions with usual care using an independently designed randomized controlled trial. Across centers, BC patients with no clinical documentation of previous HCV testing or diagnosis were randomly assigned to receive a one-time offering of HCV antibody (anti-HCV) testing via one of three independent implementation strategies (repeated-mailing outreach, electronic medical record-integrated provider best practice alert [BPA], and direct patient solicitation) or assigned to receive usual care. We estimated model-adjusted risk ratios (aRR) of anti-HCV-positive (anti-HCV+) identification using BC testing versus usual care. In the repeated mailing trial, 8992 patients (intervention, n = 2993; control, n = 5999) were included in the analysis. The intervention was eight times as likely to identify anti-HCV+ patients compared with controls (aRR, 8.0; 95% confidence interval [CI], 2.8-23.0; adjusted probabilities: intervention, 0.27%; control, 0.03%). In the BPA trial, data from 14,475 patients (BC, n = 8928; control, n = 5,547) were analyzed. The intervention was 2.6 times as likely to identify anti-HCV+ patients versus controls (aRR, 2.6; 95% CI, 1.1-6.4; adjusted probabilities: intervention, 0.29%; control, 0.11%). In the patient-solicitation trial, 8873 patients (BC, n = 4307; control, n = 4566) were analyzed. The intervention was five times as likely to identify anti-HCV+ patients compared with controls (aRR, 5.3; 95% CI, 2.3-12.3; adjusted probabilities: intervention, 0.68%; control, 0.11%). Conclusion: BC testing was effective in identifying previously undiagnosed HCV infections in primary care settings. (Hepatology 2018;67:524-533).",2018,"The intervention was five times as likely to identify anti-HCV+ patients compared with controls (aRR, 5.3; 95% CI, 2.3-12.3; adjusted probabilities: intervention, 0.68%; control, 0.11%).","['14,475 patients (BC, n = 8928; control, n = 5,547', 'persons born during 1945-1965', '8992 patients (intervention, n = 2993; control, n = 5999) were included in the analysis', 'persons born during 1945-1965 (birth cohort', 'Across centers, BC patients with no clinical documentation of previous HCV testing or diagnosis', '8873 patients (BC, n = 4307; control, n = 4566']","['HCV antibody (anti-HCV) testing via one of three independent implementation strategies (repeated-mailing outreach, electronic medical record-integrated provider best practice alert [BPA], and direct patient solicitation) or assigned to receive usual care']",['model-adjusted risk ratios (aRR) of anti-HCV-positive (anti-HCV+) identification'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0166049', 'cui_str': 'Hepatitis C Virus Antibodies'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0281863', 'cui_str': 'Anti-HCV positive'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",5999.0,0.0822748,"The intervention was five times as likely to identify anti-HCV+ patients compared with controls (aRR, 5.3; 95% CI, 2.3-12.3; adjusted probabilities: intervention, 0.68%; control, 0.11%).","[{'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Yartel', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Rein', 'Affiliation': 'NORC at the University of Chicago, Atlanta, GA.'}, {'ForeName': 'Kimberly Ann', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Krauskopf', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Omar I', 'Initials': 'OI', 'LastName': 'Massoud', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Jordan', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kil', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'Federman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Nerenz', 'Affiliation': 'Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Brady', 'Affiliation': 'NORC at the University of Chicago, Bethesda, MD.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kruger', 'Affiliation': 'NORC at the University of Chicago, Atlanta, GA.'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.29548']
754,30374683,"A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects.","BACKGROUND


A formal single ascending and multiple dose pharmacokinetic (PK) trial of cannabidiol (CBD) oral solution was required to determine the safety and tolerability of CBD, the maximum tolerated dose, and to examine the effect of food on CBD PK parameters.
OBJECTIVE


This trial assessed the safety, tolerability and PK of CBD oral solution in healthy adult volunteers, as well as the effect of food on CBD PK parameters.
METHODS


The study consisted of three arms: single ascending dose (1500, 3000, 4500 or 6000 mg CBD [n = 6 per group]/placebo [n = 8; 2 per CBD dose group]), multiple dose (750 or 1500 mg CBD [n = 9 per group]/placebo [n = 6; 3 per CBD dose group] twice daily), and food effect (1500 mg CBD single dose [n = 12]). All subjects completed all trial arms and were analyzed as planned.
RESULTS


CBD was generally well tolerated. Diarrhea, nausea, headache, and somnolence were the most common adverse events (AEs) across all trial arms, with an increased incidence of some gastrointestinal and nervous system disorder AEs (most notably diarrhea and headache) apparent in subjects taking CBD compared with placebo. All AEs were of mild or moderate severity; none were severe or serious. There were no deaths or discontinuations in the trial. After single oral doses, CBD appeared rapidly in plasma; time to maximum plasma concentration (t max ) was approximately 4-5 h. The major circulating metabolite was 7-carboxy-CBD, then parent CBD, 7-hydroxy-CBD (active metabolite), and 6-hydroxy-CBD (a relatively minor metabolite). Plasma exposure to CBD [maximum plasma concentration (C max ) and area under the plasma concentration-time curve from time zero to time t (AUC t )] increased in a less than dose-proportional manner (C max  slope 0.73; AUC t  slope 0.64). Oral clearance of CBD was high (1111-1909 L/h) and apparent volume of distribution was large (20,963-42,849 L). CBD reached steady state after approximately 2 days, with moderate accumulation (1.8- to 2.6-fold) after 750 and 1500 mg CBD twice daily. After 7 days, a twofold increase in CBD dose resulted in 1.6- and 1.9-fold increases in geometric mean C max  and area under the plasma concentration-time curve over a dosing interval (AUC τ ), respectively. CBD elimination was multiphasic; the terminal elimination half-life was approximately 60 h after 750 and 1500 mg CBD twice daily; and effective half-life estimates ranged from 10 to 17 h. C max  was 541.2 ng/mL and AUC τ  was 3236 ng·h/mL after 1500 mg CBD twice daily. A high-fat meal increased CBD plasma exposure (C max  and AUC t ) by 4.85- and 4.2-fold, respectively; there was no effect of food on t max  or terminal half-life.
CONCLUSION


CBD was generally well tolerated. Most AEs were mild in severity; none were severe or serious. The safety and PK profile support twice-daily administration of CBD.",2018,"Diarrhea, nausea, headache, and somnolence were the most common adverse events (AEs) across all trial arms, with an increased incidence of some gastrointestinal and nervous system disorder AEs (most notably diarrhea and headache) apparent in subjects taking CBD compared with placebo.","['Healthy Subjects', '3236\xa0ng·h/mL after 1500', 'healthy adult volunteers']","['cannabidiol (CBD) oral solution', 'Placebo', 'placebo']","['Safety, Tolerability and Pharmacokinetics', 'safety and tolerability of CBD', 'tolerated', 'incidence of some gastrointestinal and nervous system disorder AEs', 'major circulating metabolite was 7-carboxy-CBD, then parent CBD, 7-hydroxy-CBD (active metabolite), and 6-hydroxy-CBD', 'geometric mean C max  and area under the plasma concentration-time curve', 'Diarrhea, nausea, headache, and somnolence', 'CBD elimination', 'CBD plasma exposure (C max  and AUC t ', 'Plasma exposure to CBD [maximum plasma concentration (C max ) and area under the plasma concentration-time curve', 'safety, tolerability', 'Oral clearance of CBD', 'CBD appeared rapidly in plasma; time to maximum plasma concentration (t max ', 'CBD reached steady state', 'deaths or discontinuations', 'CBD dose']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.138123,"Diarrhea, nausea, headache, and somnolence were the most common adverse events (AEs) across all trial arms, with an increased incidence of some gastrointestinal and nervous system disorder AEs (most notably diarrhea and headache) apparent in subjects taking CBD compared with placebo.","[{'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Gidal', 'Affiliation': 'University of Wisconsin School of Pharmacy, Madison, WI, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Blakey', 'Affiliation': 'Consult2deliver Ltd, Nottingham, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK. GMorrison@gwpharm.com.'}]",CNS drugs,['10.1007/s40263-018-0578-5']
755,30624250,The Adherence of Home Pelvic Floor Muscles Training Using a Mobile Device Application for Women With Urinary Incontinence: A Randomized Controlled Trial.,"OBJECTIVES


The objective of this study was to evaluate the use of a mobile device application (app) for the treatment of urinary incontinence through adherence to home pelvic floor muscle training (PFMT) and its impact on urinary symptoms.
METHODS


This prospective randomized study included women with stress urinary incontinence. They were randomized into 2 groups: the app group, which used an app developed using the same visual component of electromyography as a guide for PFMT and followed exercises shown on the screen, and the control group, which received written instructions with the same protocol as the app group but without the dynamic sequence of PFMT images. Exercises were done twice a day. Reevaluation was repeated at 1, 2, and 3 months after the initial evaluation. Changes in urinary and vaginal symptoms were evaluated using questionnaires, and the Oxford Modified Scale was determined through digital palpation.
RESULTS


Twenty-one women were included in the study (app group, n = 12; control group, n = 09). Adherence (number of repetitions) was higher in the app group at 2 and 3 months after PFMT (P < 0.001), but adherence decrease, especially in the control group, at 1, 2, and 3 months. Vaginal symptoms (P < 0.001), quality of life (P = 0.003), urinary symptoms (P < 0.001), and stress urinary symptoms (P < 0.001) showed improvement comparing baseline and during treatment, but there was no difference between the app and control groups (P values, 0.887, 0.817, 0.573, and 0.825, respectively).
CONCLUSIONS


Using the app increased adherence to PFMT in women with urinary incontinence symptoms and improved subjective perception.",2020,"Vaginal symptoms (P < 0.001), quality of life (P = 0.003), urinary symptoms (P < 0.001), and stress urinary symptoms (P < 0.001) showed improvement comparing baseline and during treatment, but there was no difference between the app and control groups (P values, 0.887, 0.817, 0.573, and 0.825, respectively).
","['Twenty-one women were included in the study (app group, n = 12; control group, n = 09', 'women with stress urinary incontinence', 'Women With Urinary Incontinence']","['home pelvic floor muscle training (PFMT', 'Home Pelvic Floor Muscles Training Using a Mobile Device Application', 'electromyography as a guide for PFMT and followed exercises shown on the screen, and the control group, which received written instructions with the same protocol as the app group but without the dynamic sequence of PFMT images', 'mobile device application (app']","['subjective perception', 'Vaginal symptoms', 'stress urinary symptoms', 'Adherence (number of repetitions', 'quality of life', 'urinary and vaginal symptoms', 'urinary symptoms', 'adherence to PFMT']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034380'}]",21.0,0.0585559,"Vaginal symptoms (P < 0.001), quality of life (P = 0.003), urinary symptoms (P < 0.001), and stress urinary symptoms (P < 0.001) showed improvement comparing baseline and during treatment, but there was no difference between the app and control groups (P values, 0.887, 0.817, 0.573, and 0.825, respectively).
","[{'ForeName': 'Camila C', 'Initials': 'CC', 'LastName': 'Araujo', 'Affiliation': 'From the School of Medicine, University of Campinas (UNICAMP).'}, {'ForeName': 'Andrea de A', 'Initials': 'AA', 'LastName': 'Marques', 'Affiliation': ""Women's Hospital (CAISM), Campinas, São Paulo, Brazil.""}, {'ForeName': 'Cassia R T', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'From the School of Medicine, University of Campinas (UNICAMP).'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000670']
756,30544227,In the Eyes of Those Who Were Randomized: Perceptions of Disadvantaged Older Adults in a Tai Chi Trial.,"BACKGROUND AND OBJECTIVES


Older adults living in subsidized housing have typically been excluded from exercise intervention studies. We conducted a qualitative study to explore the perceived physical, psychological, social, and economic factors that influenced participation in and adherence to a year-long Tai Chi intervention within an ongoing cluster-randomized controlled trial (RCT) for older adults living within subsidized housing facilities.
RESEARCH DESIGN AND METHODS


Focus groups were held with participants of the RCT who were allocated to the trial's Tai Chi intervention. Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study. Emergent themes were extracted using grounded-theory methods.
RESULTS


In this qualitative study, we enrolled 41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study. Average Tai Chi class attendance was 64.3%. Pragmatic factors that led to higher adherence and retention included: locating classes within each facility; providing programs at no cost; and deployment of a skilled research support team. In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
DISCUSSION AND IMPLICATIONS


Perceived physical, psychological, social benefits, and self-efficacy likely enhance adherence and retention to research-based Tai Chi interventions for older adults. Delivering an on-site, no cost, and supportive program appears critical to overcoming financial and environmental barriers to participation for those living within subsidized housing.",2020,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","['Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study', 'older adults living within subsidized housing facilities', 'older adults', 'Disadvantaged Older Adults', ""41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study"", 'Older adults living in subsidized housing']",[],"['confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being', 'Average Tai Chi class attendance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",41.0,0.0925067,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","[{'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rukhadze', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Georgetti', 'Affiliation': 'New England School of Acupuncture at Massachusetts College of Pharmacy and Health Sciences, Worcester, Massachusetts.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Gagnon', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Gerontologist,['10.1093/geront/gny165']
757,32408413,"The effects of elastic band exercises and nutritional education on frailty, strength, and nutritional intake in elderly women.","PURPOSE


The purpose of this study was to examine the effects of elastic band exercises and nutritional education, as well as to identify the factors influencing frailty, strength, and nutritional intake of elderly women.
METHODS


The subjects in this study were 30 elderly women who were divided into four groups. All groups agreed to participate in four programs: health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU). Frailty was evaluated by measuring the frailty factors according to Fried et al. Leg strength was measured using a leg-extension machine. Nutritional intake was assessed by the 24-hour recall method and food records. Nutritional intake was analyzed by CAN Pro 5.0 program.
RESULTS


After three months, the prevalence of frailty significantly decreased in the EX+NU group (P=0.013) compared with that of the HE group (P=0.088). There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002). The nutritional intake significantly decreased in the EX group compared with that of the HE group (P<0.05, P<0.05).
CONCLUSION


The combination of elastic exercises and nutrition education had positive effects on frailty and leg strength, while having negative effects on total calories, carbohydrate, sodium, and iron intake in elderly women. Elastic exercises only had positive effects on leg strength while having negative effects on nutritional intake in elderly women.",2020,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","['30 elderly women who were divided into four groups', 'elderly women']","['EX+NU', 'health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU', 'elastic band exercises and nutritional education', 'Elastic exercises', 'elastic exercises and nutrition education']","['Leg strength', 'Nutritional intake', 'leg strength', 'prevalence of frailty', 'nutritional intake', 'frailty and leg strength', 'total calories, carbohydrate, sodium, and iron intake', 'frailty, strength, and nutritional intake']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",30.0,0.0132178,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Bong', 'Affiliation': ''}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0007']
758,31656631,"Chronic pelvic pain in women: an embedded qualitative study to evaluate the perceived benefits of the meridian balance method electro-acupuncture treatment, health consultation and National Health Service standard care.","Introduction


Chronic pelvic pain (CPP) - defined as intermittent or constant pain in the lower abdomen or pelvis of at least 6 months' duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy - is estimated to affect 6-27% of women worldwide. In the United Kingdom, over 1 million women suffer from CPP, which has been highlighted as a key area of unmet need. Current medical treatments for CPP are often associated with unacceptable side effects. A specific style of acupuncture, the meridian balance method electro-acupuncture (BMEA) and traditional Chinese medicine health consultation (TCM HC (BMEA + TCM HC = BMEA treatment)), may be effective for CPP in women.
Aim


Three focus group discussions and semi-structured telephone interviews were embedded in a randomised controlled feasibility trial to gain in-depth description of the perceived benefits of the participants' respective interventions.
Methods


Women with CPP were randomised into the BMEA treatment, TCM HC or National Health Service standard care (NHS SC). Focus group discussions were recorded, transcribed and analysed thematically. Semi-structured telephone interviews were conducted post focus group discussions.
Findings


A total of 30 women were randomised into BMEA treatment, TCM HC or NHS SC. A total of 11 participants attended the three focus group discussions. Thematic analysis of focus group discussions showed: a perceived pain reduction, enhanced sleep, energy level and sense of well-being in the BMEA treatment and TCM HC groups; a dislike for the adverse effects of medications, frustration at the lack of effective treatment, heavy reliance on medications and services that are helpful, in the NHS SC group. Semi-structured telephone interviews showed that the methodology was acceptable to the participants.
Conclusion


The embedded focus group discussions captured the rich and complex narratives of the participants and provided insights into the perceived benefits of the BMEA treatment, TCM HC and NHS SC interventions.",2019,"Thematic analysis of focus group discussions showed: a perceived pain reduction, enhanced sleep, energy level and sense of well-being in the BMEA treatment and TCM HC groups; a dislike for the adverse effects of medications, frustration at the lack of effective treatment, heavy reliance on medications and services that are helpful, in the NHS SC group.","['30 women', 'Chronic pelvic pain in women', '11 participants attended the three focus group discussions', 'Methods\n\n\nWomen with CPP']","['acupuncture, the meridian balance method electro-acupuncture (BMEA) and traditional Chinese medicine health consultation (TCM HC (BMEA\u2009+\u2009TCM HC', 'BMEA treatment, TCM HC or National Health Service standard care (NHS SC', 'BMEA treatment, TCM HC or NHS SC', 'BMEA treatment, TCM HC and NHS SC interventions']","['pain reduction, enhanced sleep, energy level and sense of well-being']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0047123', 'cui_str': 'CPP'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0085282', 'cui_str': 'Ching Lo'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}]",30.0,0.0951224,"Thematic analysis of focus group discussions showed: a perceived pain reduction, enhanced sleep, energy level and sense of well-being in the BMEA treatment and TCM HC groups; a dislike for the adverse effects of medications, frustration at the lack of effective treatment, heavy reliance on medications and services that are helpful, in the NHS SC group.","[{'ForeName': 'Ooi Thye', 'Initials': 'OT', 'LastName': 'Chong', 'Affiliation': 'MRC Centre for Reproductive Health, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Hilary Od', 'Initials': 'HO', 'LastName': 'Critchley', 'Affiliation': 'MRC Centre for Reproductive Health, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'MRC Centre for Reproductive Health, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fallon', 'Affiliation': 'Edinburgh Cancer Research Centre (IGMM), The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Haraldsdottir', 'Affiliation': ""St Columba's Hospice/Queen Margaret University, Edinburgh, UK.""}]",British journal of pain,['10.1177/2049463718814870']
759,31489467,The Effect of Dried Beancurd on Bone Mineral Density in Postmenopausal Chinese Women: A 2-Year Randomized Controlled Trial.,"Soy foods contain several components such as isoflavones, calcium and protein that potentially modulate bone turnover and increase bone mineral density (BMD) in postmenopausal women. The study is to evaluate the effect of dried beancurd supplementation on skeletal health in postmenopausal Chinese women. Three hundred postmenopausal women aged 50-65 years were assigned into two groups, receiving 100 g dried beancurd or rice cake a day for 2 years. BMD at the lumbar spine and right proximal femur were measured with a dual-energy X-ray absorptiometry. The bone turnover biomarkers of serum alkaline phosphatase (ALP), bone Gla protein (BGP) and urinary N-telopeptide cross-links of collagen normalized for creatinine (NTX/CRT) were also determined. Serum isoflavone concentration was analyzed by high performance liquid chromatography. The 2-year dried beancurd supplementation generated a significant increase in lumbar spine BMD. An obvious decrease was found in urinary NTX/CRT, and a significant increase was detected in serum isoflavone concentration. The dried beancurd supplementation had no effect on changes of right proximal femur BMD and concentrations of serum ALP and BGP. Daily supplementation of dried beancurd could increase BMD of lumbar spine, but does not slow bone loss at right proximal femur in postmenopausal Chinese women.",2019,The dried beancurd supplementation had no effect on changes of right proximal femur BMD and concentrations of serum ALP and BGP.,"['postmenopausal Chinese women', 'postmenopausal women', 'Three hundred postmenopausal women aged 50-65\xa0years', 'Postmenopausal Chinese Women']","['dried beancurd supplementation', 'receiving 100\xa0g dried beancurd or rice cake', 'Dried Beancurd']","['Serum isoflavone concentration', 'serum isoflavone concentration', 'lumbar spine BMD', 'BMD of lumbar spine', 'bone mineral density (BMD', 'urinary NTX/CRT', 'changes of right proximal femur BMD and concentrations of serum ALP and BGP', 'skeletal health', 'bone turnover biomarkers of serum alkaline phosphatase (ALP), bone Gla protein (BGP) and urinary N-telopeptide cross-links of collagen normalized for creatinine (NTX/CRT', 'Bone Mineral Density']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452597', 'cui_str': 'Cake (substance)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",300.0,0.0456486,The dried beancurd supplementation had no effect on changes of right proximal femur BMD and concentrations of serum ALP and BGP.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Public Health School, Xiamen University, Xiamen, 361102, Fujian, China. lilei2003@126.com.'}, {'ForeName': 'Meijun', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Public Health School, Xiamen University, Xiamen, 361102, Fujian, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Qingdao Center for Disease Control and Prevention, Qingdao, 266012, Shandong, China.'}, {'ForeName': 'Hangru', 'Initials': 'H', 'LastName': 'Kong', 'Affiliation': 'State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Public Health School, Xiamen University, Xiamen, 361102, Fujian, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': ""General Hospital of People's Liberation Army, Beijing, 100853, China. Chinazhongww301@163.com.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Public Health School, Xiamen University, Xiamen, 361102, Fujian, China.'}]",Calcified tissue international,['10.1007/s00223-019-00604-2']
760,31531828,Perioperative multi-system optimization protocol in elderly hip fracture patients: a randomized-controlled trial.,"PURPOSE


Hip fractures in elderly patients are associated with increased postoperative morbidity and mortality. We evaluated whether a perioperative multi-system optimization protocol can reduce postoperative complications in these patients.
METHODS


Immediately after diagnosis of hip fracture, patients ≥ 60 yr were randomized to an intervention or control group. Patients in the intervention group were admitted to our postanesthesia care unit where they were treated with goal-directed hemodynamic management, optimized pain therapy, oxygen therapy, and optimized nutrition. Patients in the control group were managed according to our usual standard of care on a regular ward. Postoperative complications during hospital stay included pre-determined cardiovascular, respiratory, neurologic, renal, or surgical events.
RESULTS


The incidence of at least one postoperative complication (primary outcome) was seen in 32 of 65 (49%) controls compared with 24 of 62 (39%) in the intervention group (relative risk [RR], 0.79; 95% confidence interval [CI], 0.53 to 1.17; P = 0.23). The secondary unadjusted outcomes showed that patients in the intervention group received more Ringer's acetate compared with controls (median difference, 1.3 L; 95% CI, 0.6 to 2.1 L; P < 0.001), had more frequently a mean arterial pressure > 70 mmHg (57% control vs 75% intervention; median percentage difference, 16%; 95% CI, 7 to 25%; P = 0.001), better pain control (numeric rating scale < 4 at all postoperative measurements; 25% control vs 81% intervention; RR, 0.26; 95% CI, 0.15 to 0.43; P < 0.001), and possibly a lower incidence of acute renal failure (RR, 0.37; 95% CI, 0.14 to 0.98; P = 0.04).
CONCLUSIONS


The implementation of a perioperative multi-system optimization protocol algorithm did not significantly reduce the risk of postoperative complications. Nevertheless, we likely over-estimated the potential treatment effect in our study design and thus were under-powered to show an effect.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT01673776). Registered 23 August, 2012.",2019,The implementation of a perioperative multi-system optimization protocol algorithm did not significantly reduce the risk of postoperative complications.,"['elderly hip fracture patients', 'elderly patients', 'Patients in the intervention group were admitted to our postanesthesia care unit where they were treated with', 'Immediately after diagnosis of hip fracture, patients ≥ 60 yr']","['goal-directed hemodynamic management, optimized pain therapy, oxygen therapy, and optimized nutrition', ""Ringer's acetate"", 'Perioperative multi-system optimization protocol']","['mean arterial pressure', 'Postoperative complications during hospital stay included pre-determined cardiovascular, respiratory, neurologic, renal, or surgical events', 'acute renal failure', 'risk of postoperative complications', 'postoperative complications', 'postoperative complication', 'postoperative morbidity and mortality', 'pain control (numeric rating scale']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0222045'}]",,0.227894,The implementation of a perioperative multi-system optimization protocol algorithm did not significantly reduce the risk of postoperative complications.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Haas', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lucke', 'Affiliation': 'Department of Trauma Surgery and Reconstructive Surgery, Chirurgisches Klinikum München Süd, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Neumaier', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Klinikum Freising, Freising, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany. bettina.jungwirth@tum.de.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01475-9']
761,32408817,Comparative Significance of Invasive Measures of Microvascular Injury in Acute Myocardial Infarction.,"BACKGROUND


The resistive reserve ratio (RRR) expresses the ratio between basal and hyperemic microvascular resistance. RRR measures the vasodilatory capacity of the microcirculation. We compared RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction.
METHODS


In the T-TIME trial (Trial of Low-Dose Adjunctive Alteplase During Primary PCI), 440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled. In a subset of 144 patients, IMR, CFR, and RRR were measured post-primary percutaneous coronary intervention. MVO extent (% left ventricular mass) was determined by cardiovascular magnetic resonance imaging at 2 to 7 days. Infarct size was determined at 3 months. One-year major adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations were assessed.
RESULTS


In these 144 patients (mean age, 59±11 years, 80% male), median IMR was 29.5 (interquartile range: 17.0-55.0), CFR was 1.4 (1.1-2.0), and RRR was 1.7 (1.3-2.3). MVO occurred in 41% of patients. IMR>40 was multivariably associated with more MVO (coefficient, 0.53 [95% CI, 0.05-1.02];  P =0.031), myocardial hemorrhage presence (odds ratio [OR], 3.20 [95% CI, 1.25-8.24];  P =0.016), and infarct size (coefficient, 5.05 [95% CI, 0.84-9.26];  P =0.019), independently of CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count. RRR was multivariably associated with MVO extent (coefficient, -0.60 [95% CI, -0.97 to -0.23];  P =0.002), myocardial hemorrhage presence (OR, 0.34 [95% CI, 0.15-0.75];  P =0.008), and infarct size (coefficient, -3.41 [95% CI, -6.76 to -0.06];  P =0.046). IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005). RRR was associated with heart failure hospitalization (OR, 0.44 [95% CI, 0.19-0.99]  P =0.047). CFR was not associated with infarct characteristics or clinical outcomes.
CONCLUSIONS


In acute ST-segment-elevationl infarction, IMR and RRR, but not CFR, were associated with MVO, myocardial hemorrhage, infarct size, and clinical outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02257294.",2020,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","['440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled', 'Acute Myocardial Infarction', '144 patients (mean age, 59±11 years, 80% male']",[],"['CFR', 'heart failure hospitalization', 'RRR', 'MVO', 'infarct size', 'Infarct size', 'RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction', 'myocardial hemorrhage presence', 'adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations', 'MVO, myocardial hemorrhage, infarct size, and clinical outcomes', 'IMR, CFR, and RRR', 'CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count', 'IMR>40', 'median IMR', 'major adverse cardiac events']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877077', 'cui_str': 'Myocardial haemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",440.0,0.426171,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Maznyczka', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, United Kingdom (J.P.G.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Wolverhampton University Hospital NHS Trust, United Kingdom (J.C.).'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Petrie', 'Affiliation': 'University Hospital Monklands, NHS Lanarkshire, United Kingdom (C.J.P.).'}, {'ForeName': 'Aengus', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008505']
762,32408412,The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise.,"PURPOSE


The purpose of this study was to investigate the effects of short-term creatine intake on muscle fatigue induced by resistance exercise in healthy adolescent men, i.e., lactic acid concentration and wrist and head tremor measured by an accelerometer.
METHODS


Twelve healthy adolescent men who had no experience with creatine intake were included. The subjects were randomly assigned to the creatine group and the placebo group, followed by 5 days of creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM). The lactic acid concentration before and after exercising, rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise were measured. Subsequently, after 7 days to allow for creatine washout, the same exercise treatment and measurement were performed in each group after switching drug and placebo between the groups.
RESULTS


The level of lactic acid before and after the acute resistance exercise trial was significantly lower in the creatine group than in the placebo group (P <0.05). The mean RPE during the resistance exercise was significantly lower in the creatine group than in the placebo group (P <0.05). There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
CONCLUSION


Short-term creatine intake reduces the blood fatigue factor increased by resistance exercise, and is thought to suppress fatigue, especially in the latter half of resistance exercise. Therefore, these findings indicate that short-term creatine intake can have an improved effect on anaerobic exercise performance.",2020,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","['healthy adolescent men', 'Twelve healthy adolescent men who had no experience with creatine intake were included']","['short-term creatine intake', 'creatine', 'creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM', 'placebo']","['mean wrist tremor during resistance exercise', 'rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise', 'level of lactic acid', 'mean head tremor values', 'mean RPE during the resistance exercise', 'anaerobic exercise performance', 'blood fatigue factor', 'lactic acid concentration', 'blood lactic acid and muscle fatigue', 'lactic acid concentration and wrist and head tremor']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0239882', 'cui_str': 'Head tremor'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]",12.0,0.0980171,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","[{'ForeName': 'Sinwook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Gyuseog', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nahyun', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyejoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0006']
763,31649280,Effects of intramuscular and vaginal progesterone supplementation on frozen-thawed embryo transfer.,"This study was to investigate effects of progesterone vaginal sustained-release gel and intramuscular injection of progesterone on frozen-thawed embryos transfer in 3013 patients receiving vaginal progesterone sustained-release gel and progesterone injection in artificial cycle for frozen-thawed embryo transfer. All patients were divided into two groups: group A with progesterone intramuscular injection (60 mg/d) plus dydrogesterone (10 mg tid) and group B with progesterone vaginal sustained-release gel of progesterone (90 mg/d) plus dydrogesterone (10 mg tid). There were 1988 women in group A treated with progesterone injection and 1025 women in group B with progesterone vaginal sustained-release gel. There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate. No significant (P > 0.05) differences existed in the clinical pregnancy (52.5% vs. 56.0%) and ectopic pregnancy (2.2% vs. 3.0%) rate between groups A and B. However, group B with vaginal progesterone supplementation had significantly (P < 0.05) greater implantation (37.0% vs 34.4%), delivery (45.1% vs. 41.0%) and live birth (45.0% vs. 40.8%) rate than group A with intramuscular progesterone injection, whereas group A had significantly (P < 0.05) greater early abortion rate (19.4% vs. 15.3%) than group B. This study showed that vaginal gel progesterone supplementation has good effects on frozen-thawed embryo transfer and can significantly increase the rate of implantation, delivery and live birth but decrease the abortion rate compared with intramuscular progesterone injection.",2019,"There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate.","['1988 women in group A treated with', '3013 patients receiving vaginal progesterone sustained-release gel and progesterone injection in artificial cycle for frozen-thawed embryo transfer']","['dydrogesterone', 'progesterone vaginal sustained-release gel of progesterone (90\u2009mg/d) plus dydrogesterone', 'progesterone intramuscular injection', 'vaginal progesterone supplementation', 'progesterone vaginal sustained-release gel', 'progesterone injection', 'progesterone vaginal sustained-release gel and intramuscular injection of progesterone', 'intramuscular and vaginal progesterone supplementation']","['clinical pregnancy', 'implantation', 'frozen-thawed embryo transfer', 'infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate', 'live birth', 'early abortion rate', 'rate of implantation, delivery and live birth', 'abortion rate', 'ectopic pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",3013.0,0.0200177,"There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate.","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}, {'ForeName': 'Zhuo-Ye', 'Initials': 'ZY', 'LastName': 'Luo', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}, {'ForeName': 'Gui-Min', 'Initials': 'GM', 'LastName': 'Hao', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China. haoguimin@163.com.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}]",Scientific reports,['10.1038/s41598-019-51717-5']
764,31667987,Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study).,"AIMS


Lung ultrasound (LUS) is a useful tool with which to assess subclinical pulmonary congestion and to stratify the prognosis of patients with heart failure (HF). The aim of this study was to evaluate whether an LUS-guided follow-up protocol improves the outcomes of patients with HF.
METHODS AND RESULTS


In this single-blind clinical trial, 123 patients admitted for HF were randomized to either a standard follow-up (n = 62, control group) or a LUS-guided follow-up (n = 61, LUS group). The primary endpoint was a composite of urgent visit, hospitalization for worsening HF and death during follow-up. Visits were scheduled at 14, 30, 90 and 180 days after discharge. Treating physicians were encouraged to modify diuretic therapy in accordance with the number of B-lines recorded by LUS. The mean ± standard deviation (SD) age of the patients was 69 ± 12 years and 72% were male. The mean ± SD left ventricular ejection fraction was 39 ± 14%. The hazard ratio for the primary outcome in the LUS group was 0.518 [95% confidence interval (CI) 0.268-0.998; P = 0.049], mainly resulting from a decrease in the number of urgent visits for worsening HF. The number of patients needed to treat to avoid an event was 5 (95% CI 3-62). Other secondary endpoints such as N-terminal pro-B-type natriuretic peptide reduction were not achieved. The safety parameters were similar in the two groups. Patients in the LUS group received more loop diuretics [51 (91%) vs. 42 (75%); P = 0.02] and showed an improvement in the distance achieved in the 6-min walking test [60 m (interquartile range: 29-125 m) vs. 37 m (interquartile range: 5-70 m); P = 0.023].
CONCLUSIONS


Tailored LUS-guided diuretic treatment of pulmonary congestion in this proof-of-concept study reduced the number of decompensations and improved walking capacity in patients with HF. LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.",2019,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","['123 patients admitted for HF', 'patients with HF', 'patients with heart failure (HF', 'ambulatory patients with heart failure', 'age of the patients was 69\u2009±\u200912\u2009years and 72% were male']","['Lung ultrasound-guided treatment', 'LUS-guided follow-up protocol', 'LUS-guided follow-up', 'loop diuretics', 'Lung ultrasound (LUS', 'LUS']","['number of decompensations and improved walking capacity', 'number of urgent visits for worsening HF', 'mean\u2009±\u2009SD left ventricular ejection fraction', 'composite of urgent visit, hospitalization for worsening HF and death', 'distance achieved in the 6-min walking test', 'N-terminal pro-B-type natriuretic peptide reduction', 'hazard ratio', 'mean\u2009±\u2009standard deviation (SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",123.0,0.137983,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rivas-Lasarte', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-García', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernández-Martínez', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Maestro', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Solé-González', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pirla', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Mesado', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mirabet', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fluvià', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vicens', 'Initials': 'V', 'LastName': 'Brossa', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Roig', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cinca', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}]",European journal of heart failure,['10.1002/ejhf.1604']
765,31667501,Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.,"INTRODUCTION


High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population.
METHODS


In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16.
RESULTS


Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions.
CONCLUSIONS


This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI.
IMPLICATIONS


This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.",2020,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","['Individuals with Co-Occurring Tobacco Dependence and Serious Mental Illness', 'people with serious mental illness (SMI', 'larger sample of smokers with SMI', 'Daily smokers with SMI (N=62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16', 'patients with co-occurring tobacco use disorder and serious mental illness']","['nicotine replacement therapy and technical assistance', 'Novel Smoking Cessation App', 'Learn to Quit versus QuitGuide']","['higher usability scores', 'prevalence abstinence', 'psychiatric symptoms and adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040336', 'cui_str': 'Tobacco Use Disorder'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.229352,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rizo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Palenski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Oliver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Mcclernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz202']
766,31641754,"Efficacy and Safety of a Single Dose of Ivermectin, Diethylcarbamazine, and Albendazole for Treatment of Lymphatic Filariasis in Côte d'Ivoire: An Open-label Randomized Controlled Trial.","BACKGROUND


Improved drug regimens are needed to accelerate elimination of lymphatic filariasis in Africa. This study determined whether a single co-administered dose of ivermectin plus diethylcarbamazine plus albendazole [IDA] is noninferior to standard 3 annual doses of ivermectin plus albendazole (IA) used in many LF-endemic areas of Africa.
METHODS


Treatment-naive adults with Wuchereria bancrofti microfilaremia in Côte d'Ivoire were randomized to receive a single dose of IDA (n = 43) or 3 annual doses of IA (n = 52) in an open-label, single-blinded trial. The primary endpoint was the proportion of participants who were microfilaria (Mf) negative at 36 months. Secondary endpoints were Mf clearance at 6, 12, and 24 months; inactivation of adult worm nests; and safety.
RESULTS


At 36 months posttreatment with IDA, 18/33 (55%; 95% CI, 38-72%) cleared Mf versus 33/42 (79%; 67-91%) with IA (P = .045). At 6 and 12 months IDA was superior to IA in clearing Mf (89% [77-99%] and 71% [56-85%]), respectively, versus 34% (20-48%) and 26% (14-42%) (P < .001). IDA was equivalent to IA at 24 months (61% [45-77%] vs 54% [38-72%]; P = .53). IDA was superior to IA for inactivating adult worms at all time points. Both treatments were well tolerated, and there were no serious adverse events.
CONCLUSIONS


A single dose of IDA was superior to 2 doses of IA in reducing the overall Mf burden by 24 months. Reinfection may have contributed to the lack of sustained clearance of Mf with IDA.
CLINICAL TRIALS REGISTRATION


NCT02974049.",2020,"At 6 and 12 months IDA was superior to IA in clearing Mf (89%, CI 77-99, and 71%, CI 56-85) respectively versus 34% CI 20-48, and 26%, CI 14-42, P<0.001.","[""Treatment-naïve adults with Wuchereria bancrofti microfilaremia in Agboville district of Côte d'Ivoire"", ""lymphatic filariasis in Côte d'Ivoire""]","['IDA (N=43) or 3 annual doses of IA', 'ivermectin, diethylcarbamazine and albendazole', 'IDA', 'ivermectin plus albendazole (IA', 'ivermectin plus diethylcarbamazine plus albendazole, IDA']","['overall Mf burden', 'Mf clearance at 6, 12 and 24 months, inactivation of adult worm nests, and safety', 'Efficacy and safety', 'IDA', 'proportion of participants microfilaria (Mf)-negative', 'clearing Mf']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043272', 'cui_str': 'Filaria bancrofti'}, {'cui': 'C0013884', 'cui_str': 'Bancroftian Elephantiasis'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025980', 'cui_str': 'Microfilaria'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.246034,"At 6 and 12 months IDA was superior to IA in clearing Mf (89%, CI 77-99, and 71%, CI 56-85) respectively versus 34% CI 20-48, and 26%, CI 14-42, P<0.001.","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bjerum', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Allassane F', 'Initials': 'AF', 'LastName': 'Ouattara', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Méité', 'Initials': 'M', 'LastName': 'Aboulaye', 'Affiliation': ""Programme National de la Lutte Contre la Schistosomiase, Les Geohelminthiases et la Filariose Lymphatique, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Kouadio', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Vanga K', 'Initials': 'VK', 'LastName': 'Marius', 'Affiliation': ""Universite Alassane Ouattara Centre Hospitalier Universitaire de Bouake, Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Britt J', 'Initials': 'BJ', 'LastName': 'Andersen', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Koudou', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1050']
767,25138978,Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain.,"OBJECTIVE


Depression and anxiety are prevalent in patients with chronic pain and adversely affect pain, quality of life, and treatment response. The purpose of this psychometric study was to determine the reliability and validity of the four-item Patient Reported Outcomes Measurement Information System (PROMIS) depression and anxiety scales in patients with chronic pain.
DESIGN


Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study, a randomized clinical trial of optimized analgesic therapy.
SETTING


Five primary care clinics at the Roudebush VA Medical Center (RVAMC) in Indianapolis, Indiana.
SUBJECTS


Two hundred forty-four primary care patients with chronic musculoskeletal pain.
METHODS


All patients completed the four-item depression and anxiety scales from the PROMIS 29-item profile, as well as several other validated psychological measures. The minimally important difference (MID) using the standard error of measurement (SEM) was calculated for each scale, and convergent validity was assessed by interscale correlations at baseline and 3 months. Operating characteristics of the PROMIS measures for detecting patients who had probable major depression or were anxiety-disorder screen-positive were calculated.
RESULTS


The PROMIS scales had good internal reliability, and the MID (as represented by two SEMs) was 2 points for the depression scale and 2.5 points for the anxiety scale. Convergent validity was supported by strong interscale correlations. The optimal screening cutpoint on the 4- to 20-point PROMIS scales appeared to be 8 for both the depression and anxiety scales.
CONCLUSIONS


The PROMIS four-item depression and anxiety scales are reasonable options as ultra-brief measures for screening in patients with chronic pain.",2014,"The PROMIS scales had good internal reliability, and the MID (as represented by two SEMs) was 2 points for the depression scale and 2.5 points for the anxiety scale.","['patients with chronic pain', 'Two hundred forty-four primary care patients with chronic musculoskeletal pain', 'patients who had probable major depression or were anxiety-disorder screen-positive were calculated', 'primary care patients with chronic pain', 'Five primary care clinics at the Roudebush VA Medical Center (RVAMC) in Indianapolis, Indiana']",['optimized analgesic therapy'],"['Outcomes Measurement Information System (PROMIS) depression and anxiety scales', 'item depression and anxiety scales', 'anxiety scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}]","[{'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}]",244.0,0.0384648,"The PROMIS scales had good internal reliability, and the MID (as represented by two SEMs) was 2 points for the depression scale and 2.5 points for the anxiety scale.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana, USA; Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA; Regenstrief Institute, Inc., Indianapolis, Indiana, USA.'}, {'ForeName': 'Zhangsheng', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kean', 'Affiliation': ''}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': ''}]","Pain medicine (Malden, Mass.)",['10.1111/pme.12537']
768,31613703,Enhancing Connections-Palliative Care: A Quasi-Experimental Pilot Feasibility Study of a Cancer Parenting Program.,"Background:  In 2018, >75,000 children were newly affected by the diagnosis of advanced cancer in a parent. Unfortunately, few programs exist to help parents and their children manage the impact of advanced disease together as a family. The Enhancing Connections-Palliative Care (EC-PC) parenting program was developed in response to this gap.  Objective:  (1) Assess the feasibility of the EC-PC parenting program (recruitment, enrollment, and retention); (2) test the short-term impact of the program on changes in parent and child outcomes; and (3) explore the relationship between parents' physical and psychological symptoms with program outcomes.  Design:  Quasi-experimental two-group design employing both within- and between-subjects analyses to examine change over time and change relative to historical controls. Parents participated in five telephone-delivered and fully manualized behavioral intervention sessions at two-week intervals, delivered by trained nurses. Behavioral assessments were obtained at baseline and at three months on parents' depressed mood, anxiety, parenting skills, parenting self-efficacy, and symptom distress as well as children's behavioral-emotional adjustment (internalizing, externalizing, and anxiety/depression).  Subjects:  Parents diagnosed with advanced or metastatic cancer and receiving noncurative treatment were eligible for the trial provided they had one or more children aged 5-17 living at home, were able to read, write, and speak English, and were not enrolled in a hospice program.  Results:  Of those enrolled, 62% completed all intervention sessions and post-intervention assessments. Within-group analyses showed significant improvements in parents' self-efficacy in helping their children manage pressures from the parent's cancer; parents' skills to elicit children's cancer-related concerns; and parents' skills to help their children cope with the cancer. Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment.  Conclusion:  The EC-PC parenting program shows promise in significantly improving parents' skills and confidence in supporting their child about the cancer. Further testing of the program is warranted.",2020,"Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment.  ","['Subjects:  Parents diagnosed with advanced or metastatic cancer and receiving noncurative treatment were eligible for the trial provided they had one or more children aged 5-17 living at home, were able to read, write, and speak English, and were not enrolled in a hospice program', 'In 2018, >75,000 children were newly affected by the diagnosis of advanced cancer in a parent', 'Enhancing Connections-Palliative Care']","['Cancer Parenting Program', 'EC-PC parenting program', 'telephone-delivered and fully manualized behavioral intervention sessions']","[""parents' self-efficacy"", ""parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment"", ""mood, anxiety, parenting skills, parenting self-efficacy, and symptom distress as well as children's behavioral-emotional adjustment (internalizing, externalizing, and anxiety/depression"", 'Behavioral assessments']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0586740', 'cui_str': 'Able to read (finding)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0086422', 'cui_str': 'Hospice Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}]",17.0,0.0199027,"Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment.  ","[{'ForeName': 'Frances Marcus', 'Initials': 'FM', 'LastName': 'Lewis', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth Trice', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Farya', 'Initials': 'F', 'LastName': 'Phillips', 'Affiliation': 'The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'New Mexico State University, Las Cruces, New Mexico.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Shands', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Zahlis', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alzawad', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Hebah Ahmed', 'Initials': 'HA', 'LastName': 'Almulla', 'Affiliation': 'University of Washington, Seattle, Washington.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0163']
769,31863182,Maternal personality traits moderate treatment response in the Multimodal Treatment Study of attention-deficit/hyperactivity disorder.,"Some mothers of children with attention-deficit/hyperactivity disorder (ADHD) present with maladaptive personality profiles (high neuroticism, low conscientiousness). The moderating effect of maternal personality traits on treatment outcomes for childhood ADHD has not been examined. We evaluate whether maternal neuroticism and conscientiousness moderated response in the Multimodal Treatment Study of Children with ADHD. This is one of the first studies of this type. In a randomized controlled trial (RCT), 579 children aged 7-10 (M = 8.5); 19.7% female; 60.8% White with combined-type ADHD were randomly assigned to systematic medication management (MedMgt) alone, comprehensive multicomponent behavioral treatment (Beh), their combination (Comb), or community comparison treatment-as-usual (CC). Latent class analysis and linear mixed effects models included 437 children whose biological mothers completed the NEO Five-Factor Inventory at baseline. A 3-class solution demonstrated best fit for the NEO: MN&MC = moderate neuroticism and conscientiousness (n = 284); HN&LC = high neuroticism, low conscientiousness (n = 83); LN&HC = low neuroticism, high conscientiousness (n = 70). Per parent-reported symptoms, children of mothers with HN&LC, but not LN&HC, had a significantly better response to Beh than to CC; children of mothers with MN&MC and LN&HC, but not HN&LC, responded better to Comb&MedMgt than to Beh&CC. Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt. Children of mothers with high neuroticism and low conscientiousness benefited more from behavioral treatments (Beh vs. CC; Comb vs. MedMgt) than other children. Evaluation of maternal personality may aid in treatment selection for children with ADHD, though additional research on this topic is needed.",2020,"Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt.","['attention-deficit/hyperactivity disorder', '579 children aged 7-10 (M\u2009=\u20098.5); 19.7% female; 60.8% White with combined-type ADHD', 'Some mothers of children with attention-deficit/hyperactivity disorder (ADHD', 'children with ADHD', '437 children whose biological mothers completed the NEO Five-Factor Inventory at baseline', 'Children with ADHD', 'Children of mothers with high neuroticism and low conscientiousness']","['systematic medication management (MedMgt) alone, comprehensive multicomponent behavioral treatment (Beh), their combination (Comb), or community comparison treatment-as-usual (CC']",[],"[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337486', 'cui_str': 'Natural mother (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],579.0,0.0308211,"Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Perez Algorta', 'Affiliation': 'LA14YG, Lancaster University, Furness C73, Lancaster, UK. g.perezalgorta@lancaster.ac.uk.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'MacPherson', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hinshaw', 'Affiliation': 'University of California, Berkeley, CA, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Hechtman', 'Affiliation': 'McGill University, Montreal, Canada.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Owens', 'Affiliation': 'University of California, Berkeley, CA, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01460-z']
770,31609926,Brief Report: Zinc Supplementation and Inflammation in Treated HIV.,"OBJECTIVE


In this study, we explored the effect of zinc supplementation on markers of inflammation and monocyte activation in antiretroviral therapy-treated HIV infection.
METHODS


This is a phase I open-labeled randomized double-arm study, exploring the efficacy and safety of zinc supplementation on inflammation in ≥18-year-old people living with HIV in the US, on stable antiretroviral therapy and with zinc levels ≤75 µg/dL in the last 60 days. Patients were randomized 1:1 to zinc gluconate capsules at a dose of 45 mg (low-dose), or 90 mg (high-dose) elemental zinc daily for 16 weeks. We assessed inflammatory and gut integrity biomarkers at baseline and 16 weeks.
RESULTS


Overall, a total of 52 participants were enrolled (25 participants in the low-dose arm and 27 participants in the high-dose arm). Median (Interquartile range) age was 49 (38, 60) years, 77% were men and 73% were African Americans. At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm. Overall, 48%-60% of participants experienced a reduction in biomarkers levels. The margin of reduction ranged between 8% and 21%. This change was meaningful with large effect size (Cohen D ranging from 5 to 19).
CONCLUSIONS


In this pilot study, we found that zinc supplementation is effective at increasing circulating zinc levels. In addition, our findings provide novel data suggesting that zinc can affect a biological signature in people living with HIV and modulate biomarkers associated with clinical comorbidities.",2019,"At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm.","['52 participants were enrolled (25 participants in the low-dose arm and 27 participants in the high-dose arm', '≥18-year-old people living with HIV in the US, on stable antiretroviral therapy and with zinc levels ≤75 µg/dL in the last 60 days', 'Median (Interquartile range) age was 49 (38, 60) years, 77% were men and 73% were African Americans', 'Treated HIV']","['zinc gluconate capsules', 'zinc supplementation']","['circulating zinc levels', 'median zinc levels', 'biomarkers levels', 'markers of inflammation and monocyte activation', 'Median circulating zinc levels', 'inflammatory and gut integrity biomarkers']","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",52.0,0.524287,"At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm.","[{'ForeName': 'Sahera', 'Initials': 'S', 'LastName': 'Dirajlal-Fargo', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Infectious Diseases, Rainbow Babies and Children's Hospital, Cleveland, OH.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Medical Laboratory Science, Ohio State University School of Health and Rehabilitation Sciences, Columbus, OH.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Funderburg', 'Affiliation': 'Division of Medical Laboratory Science, Ohio State University School of Health and Rehabilitation Sciences, Columbus, OH.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Mccomsey', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Infectious Diseases, Rainbow Babies and Children's Hospital, Cleveland, OH.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002129']
771,29794257,"Integrated training (practicing, peer clinical training and OSCE assessment): a ladder to promote learning and training.","Introduction The teaching-learning process plays an effective role in training nursing students. Devising novel methods can lead to achievement of educational objectives as well as promotion of the clinical and practical training. The present study is aimed to determine the effect of integrated training, including practicing, peer clinical training and objective structured clinical examination (OSCE) assessment. Methods The interventional study was conducted on 58 freshman students. Two groups underwent a five-stage educational process; so that, all the students were trained and practiced in the skills lab, and their practical skills were investigated via the OSCE test. Afterwards, for clinical training in hospital, they were randomly divided into two groups of routine training (n = 26) and the peer-learning method (n = 32). Subsequently, in order to investigate the outcomes of the process, the OSCE test scores of the two training groups were compared both before and after the apprenticeship course. Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29). Conclusion Training clinical skills along with OSCE practice and assessment can improve the nursing students' learning as well as their practical and clinical performance. Improvement of the students' performance can lead to high-quality care nursing.",2018,"Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29).","['58 freshman students', 'training nursing students']","['routine training', 'Integrated training (practicing, peer clinical training and OSCE assessment): a ladder to promote learning and training', 'integrated training, including practicing, peer clinical training and objective structured clinical examination (OSCE) assessment']","['OSCE test scores', 'total score of the clinical skills']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336762', 'cui_str': 'Ladder, device (physical object)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skill'}]",58.0,0.014928,"Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29).","[{'ForeName': 'Mahlegha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Fatemeh Ghaedi', 'Initials': 'FG', 'LastName': 'Heidari', 'Affiliation': 'School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karzari', 'Affiliation': 'Kerman branch of Azad University, Kerman, Iran.'}, {'ForeName': 'Parvin Mangolian', 'Initials': 'PM', 'LastName': 'Shahrbabaki', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2017-0222']
772,31597934,"Short-Term Effects of Kinesio Taping in the Treatment of Latent and Active Upper Trapezius Trigger Points: two Prospective, Randomized, Sham-Controlled Trials.","The presence of myofascial trigger points (MTrPs) is one of the most common causes of musculoskeletal problems and may lead to limited professional activity. Among the various treatment methods proposed for MTrPs, Kinesio Taping (KT) is a non-invasive, painless, and less time-consuming method with fewer side effects that has become widely used as a therapeutic tool in a variety of prevention and rehabilitation protocols. The aim of the study was to evaluate the immediate and short-term efficacy of the space correction KT technique in patients with latent or active MTrPs in the upper trapezius muscle. Two parallel randomized sham-controlled trials were simultaneously executed: in trial A, ninety-seven participants with latent MTrPs were randomly assigned to either the KT (n = 51) or sham (n = 46) group; in trial B, thirty-seven participants with active MTrPs were assigned to the KT (n = 20) or sham (n = 17) group. The primary outcome was pressure pain threshold (PPT) in the upper trapezius muscle, measured with algometry. Secondary outcomes included the active range of motion (ROM) of the cervical spine (lateral flexion and rotation), measured with a cervical ROM goniometer. In each trial, two-way ANOVA tests were used to compare the study effects on the outcome measures between the groups, with time serving as the intra-group factor (baseline, immediately, and 72 h after the application) and the intervention type (KT and sham) as the between-group factor. At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI: [-7.4, 5.1]), cervical lateral flexion (trial A: mean difference 0.2 degrees; 95% CI: [-2.7, 3.1], trial B: mean difference -2.4 degrees; 95% CI: [-8.4, 3.6]), and cervical rotation (trial A: mean difference 3.7 degrees; 95% CI: [-0.1, 7.5], trial B: mean difference 1.4 degrees; 95% CI: [-5.7, 8.4]), compared to the sham groups. Thus, the results of this study do not support the use of the space correction KT technique to treat patients with latent or active myofascial trigger points in the upper trapezius muscle.",2019,"At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI:","['patients with latent or active MTrPs in the upper trapezius muscle', 'ninety-seven participants with latent MTrPs']","['MTrPs, Kinesio Taping (KT', 'space correction KT technique', 'KT', 'Kinesio Taping']","['cervical lateral flexion', 'cervical rotation', 'active range of motion (ROM) of the cervical spine (lateral flexion and rotation), measured with a cervical ROM goniometer', 'pressure pain threshold (PPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion, function (observable entity)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",97.0,0.28557,"At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI:","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Noguera-Iturbe', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Gramage', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Montañez-Aguilera', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. juanfran@uchceu.es.'}]",Scientific reports,['10.1038/s41598-019-51146-4']
773,31646707,Is plasma renin activity associated with worse outcomes in acute heart failure? A secondary analysis from the BLAST-AHF trial.,"AIMS


Neurohormonal activation characterizes chronic heart failure (HF) and is a well-established therapeutic target. Neurohormonal activation may also play a key role in acute HF (AHF). We aim to describe the association between plasma renin activity (PRA) and three AHF outcomes: (i) worsening HF or death through day 5 of hospitalization; (ii) HF rehospitalization or death through day 30; and (iii) all-cause death through day 30.
METHODS AND RESULTS


A secondary analysis of the BLAST-AHF trial was performed. Eligible patients had a history of HF, elevated natriuretic peptides, signs and symptoms of HF, systolic blood pressure >120 mmHg, and an estimated glomerular filtration rate between 20-75 mL/min/1.73 m 2  . The primary trial was neutral, with no differential effect of study drug by PRA levels. Baseline PRA levels were grouped into tertiles. Adjusted Cox proportional hazard model determined the association of PRA levels with outcomes (α set at P < 0.05). Of 618 randomized patients, 578 (93.5%) had a baseline PRA. PRA was modestly, but significantly, associated with each outcome without adjustment [worsening HF or death through day 5: hazard ratio (HR) 1.11, 95% confidence interval (CI) 1.01-1.23, P = 0.04; HF rehospitalization or death through day 30: HR 1.13, 95% CI 1.02-1.26, P = 0.02; all-cause death through day 30: HR 1.18, 95% CI 1.02-1.37, P = 0.03]. After multivariable adjustment, PRA was only significantly associated with HF rehospitalization or death through day 30 (HR 1.15, 95% CI 1.01-1.32, P = 0.04).
CONCLUSION


Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.",2019,Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.,"['Eligible patients had a history of HF, elevated natriuretic peptides, signs and symptoms of HF, systolic blood pressure >120\u2009mmHg, and an estimated glomerular filtration rate between 20-75\u2009mL/min/1.73\u2009m 2  ', 'patients with AHF', '618 randomized patients, 578 (93.5%) had a baseline PRA']",[],"['PRA levels', 'HF rehospitalization or death', 'plasma renin activity (PRA) and three AHF outcomes: (i) worsening HF or death through day 5 of hospitalization; (ii) HF rehospitalization or death through day 30; and (iii) all-cause death', 'Baseline PRA levels', 'PRA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",618.0,0.221702,Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.,"[{'ForeName': 'Rayan Jo', 'Initials': 'RJ', 'LastName': 'Rachwan', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'SUNY Stonybrook School of Medicine, New York, NY, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Senger', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, School of Medicine, Heart Failure Unit, Department of Cardiology, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Wayne State University School of Medicine and Cardiovascular Research Institute, Detroit, MI, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Clinical Military Hospital, Medical University, Wroclaw, Poland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Soergel', 'Affiliation': 'Cardiovascular and Metabolic Diseases, Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University School of Medicine and the Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1607']
774,29792087,Effects of intensive short-term dynamic psychotherapy on social cognition in major depression.,"Background : Social cognition is commonly affected in psychiatric disorders and is a determinant of quality of life. However, there are few studies of treatment. Objective : To investigate the efficacy of intensive short-term dynamic psychotherapy on social cognition in major depression. Method : This study used a parallel group randomized control design to compare pre-test and post-test social cognition scores between depressed participants receiving ISTDP and those allocated to a wait-list control group. Participants were adults (19-40 years of age) who were diagnosed with depression. We recruited 32 individuals, with 16 participants allocated to the ISTDP and control groups, respectively. Both groups were similar in terms of age, sex and educational level. Results : Multivariate analysis of variance (MANOVA) demonstrated that the intervention was effective in terms of the total score of social cognition: the experimental group had a significant increase in the post-test compared to the control group. In addition, the experimental group showed a significant reduction in the negative subjective score compared to the control group as well as an improvement in response to positive neutral and negative states. Conclusion : Depressed patients receiving ISTDP show a significant improvement in social cognition post treatment compared to a wait-list control group.",2020,"RESULTS


Multivariate analysis of variance (MANOVA) demonstrated that the intervention was effective in terms of the total score of social cognition: the experimental group had a significant increase in the post-test compared to the control group.","['major depression', 'Participants were adults (19-40 years of age) who were diagnosed with depression', 'depressed participants receiving ISTDP and those allocated to a wait-list control group', '32 individuals, with 16 participants allocated to the']","['ISTDP', 'intensive short-term dynamic psychotherapy']","['response to positive neutral and negative states', 'total score of social cognition', 'social cognition scores', 'social cognition', 'negative subjective score']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.0256528,"RESULTS


Multivariate analysis of variance (MANOVA) demonstrated that the intervention was effective in terms of the total score of social cognition: the experimental group had a significant increase in the post-test compared to the control group.","[{'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Ajilchi', 'Affiliation': 'Department of Psychology, Faculty of Human Science, Science and Research Branch, Islamic Azad University (IAU), Tehran, Iran.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kisely', 'Affiliation': 'Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Faculty of Human Science, Shahid Beheshti University, Tehran, Iran, and.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Frederickson', 'Affiliation': 'MSW Faculty, Washington School of Psychiatry, Washington, DC, USA.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2018.1466035']
775,30277850,Changes in nutrient intake and inflammation following an anti-inflammatory diet in spinal cord injury.,"Objective:  The objective of the current study was to describe the observed changes in nutrient intakes following a 3-month anti-inflammatory diet, and to explore potential relationships between the change in nutrients and the change in various inflammatory mediators. Design:  A secondary analysis of a prior randomized controlled clinical trial. Setting:  Individuals with SCI within the Niagara region. Participants:  Twenty individuals with various levels and severities of SCI. Intervention:  Three-month anti-inflammatory diet. Outcome Measures:  The change in nutrient intake and corresponding changes to various inflammatory mediators. Results:  The treatment group demonstrated a significant reduction in fat intake (P = 0.02), a significant increase in protein intake (P = 0.02), and no change in carbohydrates (P = 0.23) or energy intake (P = 0.10). The treatment group showed a significant increase in some nutrients with established anti-inflammatory properties including vitamins A, C, and E, and omega-3 fatty acids (P < 0.01). Significant reductions in proinflammatory nutrients were observed including trans fatty acids (P = 0.05), caffeine (P < 0.01), and sodium (P = 0.02). The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05). Further, several proinflammatory mediators were negatively correlated with anti-inflammatory nutrients, including vitamin A, carotenoids, omega-3 fatty acids, and zinc. Conclusion:  This study provides evidence that dietary alterations are effective at reducing chronic inflammation in individuals with SCI and provides a preliminary assessment of the related nutrient changes.",2019,"The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05).","['Individuals with SCI within the Niagara region', 'spinal cord injury', 'individuals with SCI', 'Twenty individuals with various levels and severities of SCI']",[],"['fat intake', 'some nutrients with established anti-inflammatory properties including vitamins A, C, and E, and omega-3 fatty acids', 'proinflammatory mediators interferon-y', 'energy intake', 'protein intake', 'trans fatty acids', 'change in carbohydrates', 'proinflammatory nutrients']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",[],"[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",20.0,0.0468138,"The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Allison', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Kayleigh M', 'Initials': 'KM', 'LastName': 'Beaudry', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Aysha M', 'Initials': 'AM', 'LastName': 'Thomas', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ditor', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}]",The journal of spinal cord medicine,['10.1080/10790268.2018.1519996']
776,30442714,Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma.,"Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β 2 -agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS dose of ≤5 mg, those with a ≥50% reduction in prescribed maintenance OCS dose and asthma exacerbation rate. Safety was also assessed.At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271). There were no significant between-treatment differences for any secondary end-point. Overall, reporting of adverse events and serious adverse events were similar for the tralokinumab and placebo groups. Although a greater proportion of tralokinumab-treated patients reported upper respiratory tract infections (35.7%  versus  14.3%), there were no reported cases of pneumonia.Overall, tralokinumab did not demonstrate an OCS-sparing effect in patients with severe asthma.",2019,"At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271).","['patients with severe asthma', '140 patients', 'patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β 2 -agonists']","['OCS-sparing potential of tralokinumab', 'placebo', 'Tralokinumab', 'corticosteroid (OCS', 'tralokinumab 300\u2005mg or placebo']","['OCS-sparing effect', 'upper respiratory tract infections', 'prescribed maintenance OCS dose and asthma exacerbation rate', 'Overall, reporting of adverse events and serious adverse events', 'Safety', 'proportion of patients with a prescribed maintenance OCS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",140.0,0.556496,"At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62%  versus  29.85%; p=0.271).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Dept of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Brusselle', 'Affiliation': 'Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Dept, Mainz University Hospital, Mainz, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Dept of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Magnan', 'Affiliation': 'Institut du Thorax, INSERM CNRS, Université de Nantes, CHU de Nantes, Nantes, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Piechowiak', 'Affiliation': 'AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Millie M', 'Initials': 'MM', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",The European respiratory journal,['10.1183/13993003.00948-2018']
777,31641199,Calibrated interdental brushing for the prevention of periodontal pathogens infection in young adults - a randomized controlled clinical trial.,"Periodontal disease is clearly correlated with systemic disease. The presence of periodontal pathogens in interdental spaces in young, healthy adults is a strong indicator of the need to introduce daily interdental prophylaxis. Twenty-five subjects (aged 18-35 years), diagnosticated clinically as periodontally healthy, were enrolled in this study. One hundred interdental sites were included. Among these sites, 50 ""test"" sites were cleaned daily with calibrated interdental brushes (IDBs), whereas the other 50 sites were not cleaned and considered ""controls"". The interdental biofilm at these interdental sites was collected at the beginning of the study (basal) and at 1 week, 2 weeks, 3 weeks, 4 weeks, and 3 months. Real-time polymerase chain reaction (PCR) methodology was used to quantify (i) 19 periodontal bacteria, including Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, and (ii) total bacteria. In the test sites, the quantity of total bacteria decreased over time with the use of IDBs. The bacteria from the red and orange Socransky complexes, which are associated with periodontal disease, significantly decreased in the test sites but not in the control sites. Bacteria from the yellow, and purple Socransky complexes, which are associated with periodontal health, increased significantly in both groups whereas bacteria from the blue Socransky complex increased significantly only in the test sites. Furthermore, at basal, 66% of test sites and 68% of control sites bled during interdental brushing. These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites. In conclusion, the daily use of calibrated IDBs can reduce periodontal pathogens, reestablish symbiotic microbiota and, decrease interdental inflammation in interdental sites of healthy young adults.",2019,These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites.,"['One hundred interdental sites were included', 'young adults', 'young, healthy adults', 'healthy young adults', 'Twenty-five subjects (aged 18-35 years), diagnosticated clinically as periodontally healthy']","['calibrated IDBs', 'Calibrated interdental brushing', 'Real-time polymerase chain reaction (PCR) methodology']","['interdental inflammation', 'quantity of total bacteria', 'Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, and (ii) total bacteria']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}]",25.0,0.0172873,These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites.,"[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Bourgeois', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Bravo', 'Affiliation': 'Department of Preventive and Community Dentistry, Faculty of Oral Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan-Carlos', 'Initials': 'JC', 'LastName': 'Llodra', 'Affiliation': 'Department of Preventive and Community Dentistry, Faculty of Oral Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Inquimbert', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Viennot', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Dussart', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Carrouel', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France. florence.carrouel@univ-lyon1.fr.'}]",Scientific reports,['10.1038/s41598-019-51938-8']
778,31664156,Repeated buffered acidic saline infusion in the human masseter muscle as a putative experimental pain model.,"This study investigated if repeated buffered acidic saline infusions into the masseter muscles induced muscle pain and mechanical sensitization. Fourteen healthy men participated in this double-blind, randomized, and placebo-controlled study. Two repeated infusions (day 1 and 3) were given in the masseter muscles with either a buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control. After 10 days of wash-out, the experiment was repeated with the other substance. Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings were assessed before, directly following, and after each infusion at 5, 15, and 30 min and on day 4 and 7. Fatigue and pain intensity were assessed after a one-minute chewing test 30 min after infusions and day 4 and 7. Acidic saline induced higher pain intensity than control day 3 up to 5 min after infusions, but did not affect PPT. The chewing test did not evoke higher fatigue during chewing or MUO or after acidic saline infusion compared to control. Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain. Hence, this model might not be superior to already existing experimental muscle pain models.",2019,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,['Fourteen healthy men'],"['acidic saline infusions', 'buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control', 'placebo', 'acidic saline', 'Acidic saline', 'acidic saline infusion']","['Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings', 'muscle pain and mechanical sensitization', 'Fatigue and pain intensity', 'higher pain intensity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",14.0,0.386685,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,"[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Louca Jounger', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden. Sofia.Louca@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Eriksson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindskog', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oscarsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Simonsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Christidis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}]",Scientific reports,['10.1038/s41598-019-51670-3']
779,30523161,Human diaphragm atrophy in amyotrophic lateral sclerosis is not predicted by routine respiratory measures.,"Amyotrophic lateral sclerosis (ALS) patients show progressive respiratory muscle weakness leading to death from respiratory failure. However, there are no data on diaphragm histological changes in ALS patients and how they correlate with routine respiratory measurements.We collected 39 diaphragm biopsies concomitantly with laparoscopic insertion of intradiaphragmatic electrodes during a randomised controlled trial evaluating early diaphragm pacing in ALS (https://clinicaltrials.gov; NCT01583088). Myofibre type, size and distribution were evaluated by immunofluorescence microscopy and correlated with spirometry, respiratory muscle strength and phrenic nerve conduction parameters. The relationship between these variables and diaphragm atrophy was assessed using multivariate regression models.All patients exhibited significant slow- and fast-twitch diaphragmatic atrophy. Vital capacity (VC), maximal inspiratory pressure, sniff nasal inspiratory pressure (SNIP) and twitch transdiaphragmatic pressure did not correlate with the severity of diaphragm atrophy. Inspiratory capacity (IC) correlated modestly with slow-twitch myofibre atrophy. Supine fall in VC correlated weakly with fast-twitch myofibre atrophy. Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.Routine respiratory tests are poor predictors of diaphragm structural changes. Improved detection of diaphragm atrophy is essential for clinical practice and for management of trials specifically targeting diaphragm muscle function.",2019,"Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.","['ALS patients', 'Amyotrophic lateral sclerosis (ALS) patients']",['diaphragm biopsies concomitantly with laparoscopic insertion of intradiaphragmatic electrodes'],"['diaphragm histological changes', 'slow- and fast-twitch diaphragmatic atrophy', 'IC, SNIP and functional residual capacity', 'Vital capacity (VC), maximal inspiratory pressure, sniff nasal inspiratory pressure (SNIP) and twitch transdiaphragmatic pressure', 'Inspiratory capacity (IC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0016815', 'cui_str': 'Functional Residual Capacity'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C1720573', 'cui_str': 'Sniff'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach (qualifier value)'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory Capacity'}]",39.0,0.0538725,"Multivariate analysis showed that IC, SNIP and functional residual capacity were independent predictors of slow-twitch diaphragmatic atrophy, but not fast-twitch atrophy.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Guimarães-Costa', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rivals', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Capucine', 'Initials': 'C', 'LastName': 'Morélot-Panzini', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, Paris, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Nierat', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Mai Thao', 'Initials': 'MT', 'LastName': 'Bui', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Unité de Morphologie Neuromusculaire, Institut de Myologie, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Akbar', 'Affiliation': 'CELIS Cell Culture Core Facility, Institut du Cerveau et de la Moelle Épinière, ICM, INSERM U1127, CNRS UMR 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Straus', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Norma Beatriz', 'Initials': 'NB', 'LastName': 'Romero', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Unité de Morphologie Neuromusculaire, Institut de Myologie, Paris, France.'}, {'ForeName': 'Patrick Pierre', 'Initials': 'PP', 'LastName': 'Michel', 'Affiliation': 'CELIS Cell Culture Core Facility, Institut du Cerveau et de la Moelle Épinière, ICM, INSERM U1127, CNRS UMR 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Menegaux', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Chirurgie Générale et Endocrinologique, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salachas', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': 'Jésus', 'Initials': 'J', 'LastName': 'Gonzalez-Bermejo', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Bruneteau', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Département de Neurologie, Centre référent SLA, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01749-2018']
780,29907079,A Comparison of Different Intensities of Patient Navigation After Abnormal Mammography.,"Background . Patient navigation is a practice strategy to address barriers to timely diagnosis and treatment of cancer. The aim of this study was to examine the effectiveness of varying intensities of patient navigation and timely diagnostic resolution after abnormal mammography.  Method . This is a secondary analysis of a subset of women with an abnormal screening or diagnostic mammogram who participated in the ""patient navigation in medically underserved areas"" 5-year randomized trial. We compared timely diagnostic resolution in women assigned to different intensities of patient navigation including, full navigation intervention, no contact with navigators, or limited contact with navigators.  Results . The sample included 1,725 women with abnormal mammogram results. Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators.  Discussion . Results from our study suggest that even limited contact with navigators encourages women to seek more timely diagnostic resolution after an abnormal mammogram, which may offer a low-cost practice strategy to improve timely diagnosis for disadvantaged and underserved women.",2019,"Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators.
","['1,725 women with abnormal mammogram results', 'disadvantaged and underserved women', 'women with an abnormal screening or diagnostic mammogram who participated in the ""patient navigation in medically underserved areas"" 5-year randomized trial']","['Patient Navigation', 'full navigation intervention, no contact with navigators, or limited contact with navigators']",['diagnostic resolution'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262365', 'cui_str': 'Mammography abnormal (finding)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0411881', 'cui_str': 'Mammogram - symptomatic (procedure)'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0025112', 'cui_str': 'Medically Underserved Area'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",1725.0,0.0861541,"Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators.
","[{'ForeName': 'Anne Elizabeth', 'Initials': 'AE', 'LastName': 'Glassgow', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Molina', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sage', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Darnell', 'Affiliation': 'Loyola University, Maywood, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Calhoun', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}]",Health promotion practice,['10.1177/1524839918782168']
781,31558739,"Rice bran supplementation modulates growth, microbiota and metabolome in weaning infants: a clinical trial in Nicaragua and Mali.","Rice bran supplementation provides nutrients, prebiotics and phytochemicals that enhance gut immunity, reduce enteric pathogens and diarrhea, and warrants attention for improvement of environmental enteric dysfunction (EED) in children. EED is a subclinical condition associated with stunting due to impaired nutrient absorption. This study investigated the effects of rice bran supplementation on weight for age and length for age z-scores (WAZ, LAZ), EED stool biomarkers, as well as microbiota and metabolome signatures in weaning infants from 6 to 12 months old that reside in Nicaragua and Mali. Healthy infants were randomized to a control (no intervention) or a rice bran group that received daily supplementation with increasing doses at each month (1-5 g/day). Stool microbiota were characterized using 16S rDNA amplicon sequencing. Stool metabolomes were analyzed using ultra-high-performance liquid-chromatography tandem mass-spectrometry. Statistical comparisons were completed at 6, 8, and 12 months of age. Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control. WAZ was significantly improved only for Mali infants at 8 and 12 months. Mali and Nicaraguan infants showed major differences in the overall gut microbiota and metabolome composition and structure at baseline, and thus each country cohort demonstrated distinct microbial and metabolite profile responses to rice bran supplementation when compared to control. Rice bran is a practical dietary intervention strategy that merits development in rice-growing regions that have a high prevalence of growth stunting due to malnutrition and diarrheal diseases. Rice is grown as a staple food, and the bran is used as animal feed or wasted in many low- and middle-income countries where EED and stunting is prevalent.",2019,Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control.,"['weaning infants', 'children', 'Healthy infants', 'weaning infants from 6 to 12 months old that reside in Nicaragua and Mali']","['Rice bran supplementation', 'control (no intervention) or a rice bran group that received daily supplementation', 'Rice bran', 'rice bran', 'rice bran supplementation']","['overall gut microbiota and metabolome composition and structure', 'growth, microbiota and metabolome', 'weight for age and length for age z-scores (WAZ, LAZ), EED stool biomarkers', 'Stool metabolomes', 'WAZ', 'safe and feasible to support changes in LAZ']","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028002', 'cui_str': 'Nicaragua'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}]","[{'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0249178,Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control.,"[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Zambrana', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Starin', 'Initials': 'S', 'LastName': 'McKeen', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Hend', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Zarei', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Erica C', 'Initials': 'EC', 'LastName': 'Borresen', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lassina', 'Initials': 'L', 'LastName': 'Doumbia', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Boré', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Alima', 'Initials': 'A', 'LastName': 'Cissoko', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Seydou', 'Initials': 'S', 'LastName': 'Douyon', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Koné', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Perez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hess', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Abdo', 'Affiliation': 'Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, 80521, USA.'}, {'ForeName': 'Lansana', 'Initials': 'L', 'LastName': 'Sangaré', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Ababacar', 'Initials': 'A', 'LastName': 'Maiga', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Becker-Dreps', 'Affiliation': 'Departments of Family Medicine and Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7595, USA.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Biomedical Sciences and Pathobiology, Virginia-Maryland College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg, VA, 24061, USA.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Koita', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali. okoita@icermali.org.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Vilchez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua. samuelvilchez@gmail.com.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Ryan', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA. E.P.Ryan@colostate.edu.'}]",Scientific reports,['10.1038/s41598-019-50344-4']
782,31664452,Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial.,"Importance


Poor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict.
Objective


To compare the effectiveness of a question prompt list (QPL) intervention vs usual care on patient engagement and well-being among older patients considering major surgery.
Design, Setting, and Participants


This randomized clinical trial used a stepped-wedge design to randomly assign patients to a QPL intervention (n = 223) or usual care (n = 223) based on the timing of their visit with 1 of 40 surgeons at 5 US study sites. Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery. Family members were also enrolled (n = 263). The study dates were June 2016 to November 2018. Data analysis was by intent-to-treat.
Interventions


A brochure of 11 questions to ask a surgeon developed by patient and family stakeholders plus an endorsement letter from the surgeon were sent to patients before their outpatient visit.
Main Outcomes and Measures


Primary patient engagement outcomes included the number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale assessed after the surgical visit. Primary well-being outcomes included (1) the difference between patient's Measure Yourself Concerns and Well-being (MYCaW) scores reported after surgery and scores reported after the surgical visit and (2) treatment-associated regret at 6 to 8 weeks after surgery.
Results


Of 1319 patients eligible for participation, 223 were randomized to the QPL intervention and 223 to usual care. Among 446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male. On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes. The difference in MYCaW scores for family members was greater in usual care (effect estimate, 1.51; 95% CI, 0.28-2.74; P = .008). When the QPL intervention group was restricted to patients with clear evidence they reviewed the QPL, a nonsignificant increase in the effect size was observed for questions about options (odds ratio, 1.88; 95% CI, 0.81-4.35; P = .16), expectations (odds ratio, 1.59; 95% CI, 0.67-3.80; P = .29), and risks (odds ratio, 2.41; 95% CI, 1.04-5.59; P = .04) (nominal α = .01).
Conclusions and Relevance


The results of this study were null related to primary patient engagement and well-being outcomes. Changing patient-physician communication may be difficult without addressing clinician communication directly.
Trial Registration


ClinicalTrials.gov identifier: NCT02623335.",2019,"On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes.","['Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery', 'older patients considering major surgery', 'Older Patients', '1319 patients eligible for participation, 223 were randomized to the', 'Family members were also enrolled (n\u2009=\u2009263', '446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male']","['Question Prompt List Intervention', 'Major Surgery', 'QPL intervention (n\u2009=\u2009223) or usual care', 'QPL intervention', 'question prompt list (QPL) intervention vs usual care']","['number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale', 'effect size', 'MYCaW scores', ""patient's Measure Yourself Concerns and Well-being (MYCaW) scores""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0222045'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1319.0,0.121502,"On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes.","[{'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Schwarze', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Buffington', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Tucholka', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Hanlon', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rathouz', 'Affiliation': 'Department of Population Health, The University of Texas at Austin, Austin.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Marka', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kata', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Baggett', 'Affiliation': 'Department of Surgery, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Fox', 'Affiliation': 'School of Medicine, Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Schmick', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Berlin', 'Affiliation': 'Division of General Surgery, Department of Surgery, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Nina E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Department of Surgery, Rutgers New Jersey Medical School, Newark.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Mosenthal', 'Affiliation': 'Department of Surgery, Rutgers New Jersey Medical School, Newark.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Finlayson', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Cooper', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Brasel', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland.'}]",JAMA surgery,['10.1001/jamasurg.2019.3778']
783,31545663,Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.,"PURPOSE


Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment.
METHODS


We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/μL for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care. The primary end point was correction of platelet count within 3 weeks. Twenty-three patients were treated in a randomization phase, and an additional 37 patients were treated in a single-arm, romiplostim phase. Resumption of chemotherapy without recurrent CIT was a secondary end point.
RESULTS


The mean platelet count at enrollment was 62,000/μL. In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared with one of eight control patients (12.5%;  P  < .001). Including all romiplostim-treated patients (N = 52), the mean platelet count at 2 weeks of treatment was 141,000/μL. The mean platelet count in the eight observation patients at 3 weeks was 57,000/μL. Forty-four patients who achieved platelet correction with romiplostim resumed chemotherapy with weekly romiplostim. Only three patients (6.8%) experienced recurrent reduction or delay of chemotherapy because of isolated CIT.
CONCLUSION


This prospective trial evaluated treatment of CIT with romiplostim. Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",2019,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",['patients with solid tumors with CIT'],"['romiplostim', 'titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care']","['recurrent reduction or delay of chemotherapy', 'despite delay or dose reduction of chemotherapy', 'mean platelet count', 'correction of platelet count', 'correction of their platelet count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}]","[{'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1299577', 'cui_str': 'Delay of chemotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",44.0,0.0328062,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.","[{'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Bendheim', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Batista', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jodi V', 'Initials': 'JV', 'LastName': 'Mones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Cy R', 'Initials': 'CR', 'LastName': 'Wilkins', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Devlin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Kemeny', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mantha', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01931']
784,32408868,Strategies for evaluating self-efficacy and observed success in the practice of yoga postures for therapeutic indications: methods from a yoga intervention for urinary incontinence among middle-aged and older women.,"BACKGROUND


Most clinical investigations involving yoga lack adequate description of the specific yoga elements, including physical postures. Few studies have measured self-efficacy regarding the performance of yoga postures or assessed observed success in performing postures.
METHODS


We developed and piloted several tools to evaluate self-efficacy and observed success in practicing yoga in the context of a randomized feasibility trial of an Iyengar-based yoga intervention for urinary incontinence in ambulatory women ≥50 years. At the end of the 12-week yoga intervention involving twice weekly group yoga classes and once weekly home practice, participants rated their self-efficacy in performing each of the included 15 yoga postures on a 5-point Likert scale. During the 12th week, an expert yoga consultant observed participants and rated their competency in performing postures on a 5-point scale. Participants completed a questionnaire about self-efficacy in adhering to home yoga practice. We examined the distribution of and correlations between scores on the above measures.
RESULTS


Among 27 participants (mean age 65 years), the range of means for self-efficacy ratings for individual postures was 3.6 to 4.5. The range of means for observed competency ratings for individual postures was 3.3 to 5.0. Mean self-efficacy rating for confidence in adhering to the assigned once-weekly home yoga practice was 2.8 (range 1 to 5). Posture self-efficacy was inversely correlated with participant age (p = 0.01) and positively correlated with self-reported physical function (p = 0.03) and mobility (p = 0.01). No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
CONCLUSIONS


These measures hold promise for advancing yoga research and practice by describing methods to: 1) measure self-efficacy in performing specific yoga postures; 2) use an expert observer to assess participants' competence in performing yoga postures; and 3) measure self-efficacy in adhering to home practice. These proposed measures can be used to describe specific components of yoga interventions, to assess whether study participants are able to learn to practice physical aspects of yoga and/or maintain this practice over time, as well as to investigate relationships between self-efficacy and competency in performing yoga postures to achieve specific health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02342678, January 21, 2015.",2020,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","['27 participants (mean age 65\u2009years', 'urinary incontinence among middle-aged and older women', 'ambulatory women ≥50\u2009years']","['practicing yoga', 'Iyengar-based yoga intervention', 'yoga intervention']","['Posture self-efficacy', 'physical function', 'posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores', 'range of means for self-efficacy ratings for individual postures', 'Mean self-efficacy rating']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0380961,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","[{'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Nicosia', 'Affiliation': 'Division of Geriatrics and Institute for Health & Aging, University of California, San Francisco, USA. Francesca.nicosia@ucsf.edu.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Center for Tobacco Control Research and Education and Division of General Internal Medicine, University of California San Francisco, 530 Parnassus, Ste 366, San Francisco, CA, 94143-1390, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Chesney', 'Affiliation': 'Department of Medicine and Osher Center for Integrative Medicine, University of California San Francisco, 1545 Divisadero, San Francisco, CA, 94118, USA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, 300 Pasteur Drive, HG332, Office #G-303A, Stanford, California, 94305-5317, USA.'}, {'ForeName': 'Traci M', 'Initials': 'TM', 'LastName': 'Plaut', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, Street Suite 201, Sutter, 2320, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, 1545 Divisadero Street, San Francisco, CA, 94118, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02934-3']
785,30461381,Do AB0 blood groups affect lower urinary tract symptoms?,"OBJECTIVE


The aim of this study is to investigate whether there is a correlation between AB0 blood group antigens and Rhesus factor and lower urinary tract symptoms (LUTS).
MATERIAL AND METHODS


A total of 556 male patients applying to our clinic with LUTS complaints from April 2012-2015 and complying with the study criteria were included in the study. The patients were divided into two groups as those with (Group 1; n=283) and without LUTS (Group 2; n=273) complaints. The effect of blood groups on LUTS complaints was compared using univariate logistic regression analyzes.
RESULTS


According to AB0 blood groups, blood groups A (56.7%) and AB (56.9%) were most common in the LUTS group. But 0 blood group (44.1%) was the least common. According to rhesus factor, the incidence of LUTS in Rh (+), and Rh (-) groups were 48.9%, and 66.7%, respectively. Compared to 0 blood group, the LUTS incidence was 1.65, and 1.66 times higher for individuals with blood groups A, and AB, respectively. The same risk increased 2.09 times for individuals with Rhesus factor negative.
CONCLUSION


This study identified a correlation between AB0 blood group and Rhesus factor and LUTS. The risk of LUTS risk increased in individuals with blood group A Rh (). Additionally there was a clear risk increase observed for AB blood group, though this did not reach statistical significance.",2019,"Compared to 0 blood group, the LUTS incidence was 1.65, and 1.66 times higher for individuals with blood groups A, and AB, respectively.",['556 male patients applying to our clinic with LUTS complaints from April 2012-2015 and complying with the study criteria were included in the study'],"['AB0 blood group and Rhesus factor and LUTS', 'without LUTS']","['urinary tract symptoms', 'LUTS risk', 'LUTS incidence']","[{'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0005810', 'cui_str': 'Blood Groups'}]","[{'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",556.0,0.0163247,"Compared to 0 blood group, the LUTS incidence was 1.65, and 1.66 times higher for individuals with blood groups A, and AB, respectively.","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Benli', 'Affiliation': 'Department of Urology, Ordu University School of Medicine, Ordu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Çırakoğlu', 'Affiliation': 'Department of Urology, Ordu University School of Medicine, Ordu, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Öğreden', 'Affiliation': 'Department of Urology, Giresun University School of Medicine, Giresun, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Internal Medicine, Ordu University School of Medicine, Ordu, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ayyıldız', 'Affiliation': 'Department of Urology, Bozok University School of Medicine, Yozgat, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yüce', 'Affiliation': 'Department of Urology, Ordu University School of Medicine, Ordu, Turkey.'}]",Turkish journal of urology,['10.5152/tud.2018.25295']
786,31863557,"A randomised, double-blind, placebo-controlled trial of metformin on myocardial efficiency in insulin-resistant chronic heart failure patients without diabetes.","AIMS


The present study tested the hypothesis that metformin treatment may increase myocardial efficiency (stroke work/myocardial oxygen consumption) in insulin-resistant patients with heart failure and reduced ejection fraction (HFrEF) without diabetes.
METHODS AND RESULTS


Thirty-six HFrEF patients (ejection fraction 37 ± 8%; median age 66 years) were randomised to metformin (n = 19) or placebo (n = 17) for 3 months in addition to standard heart failure therapy. The primary endpoint was change in myocardial efficiency expressed as the work metabolic index (WMI), assessed by  11  C-acetate positron emission tomography and transthoracic echocardiography. Compared with placebo, metformin treatment (1450 ± 550 mg/day) increased WMI [absolute mean difference, 1.0 mmHg·mL·m -2  ·10 6  ; 95% confidence interval (CI) 0.1 to 1.8; P = 0.03], equivalent to a 20% relative efficiency increase. Patients with above-median plasma metformin levels displayed greater WMI increase (25% vs. -4%; P = 0.02). Metformin reduced myocardial oxygen consumption (-1.6 mL O 2  ·100 g -1  ·min -1  ; P = 0.014). Cardiac stroke work was preserved (-2 J; 95% CI -11 to 7; P = 0.69). Metformin reduced body weight (-2.2 kg; 95% CI -3.6 to -0.8; P = 0.003) and glycated haemoglobin levels (-0.2%; 95% CI -0.3 to 0.0; P = 0.02). Changes in resting and exercise ejection fraction, global longitudinal strain, and exercise capacity did not differ between groups.
CONCLUSION


Metformin treatment in non-diabetic HFrEF patients improved myocardial efficiency by reducing myocardial oxygen consumption. Measurement of circulating metformin levels differentiated responders from non-responders. These energy-sparing effects of metformin encourage further large-scale investigations in heart failure patients without diabetes.",2020,Cardiac stroke work was preserved (-2 J; 95% CI -11 to 7; P = 0.69).,"['Thirty-six HFrEF patients (ejection fraction 37\u2009±\u20098%; median age 66\u2009years', 'heart failure patients without diabetes', 'insulin-resistant chronic heart failure patients without diabetes', 'insulin-resistant patients with heart failure and reduced ejection fraction (HFrEF) without diabetes']","['placebo', 'Metformin', 'metformin', 'placebo, metformin']","['myocardial oxygen consumption', 'resting and exercise ejection fraction, global longitudinal strain, and exercise capacity', 'Cardiac stroke work', 'WMI increase', 'myocardial efficiency', 'myocardial efficiency (stroke work/myocardial oxygen consumption', 'glycated haemoglobin levels', 'myocardial efficiency expressed as the work metabolic index (WMI), assessed by  11  C-acetate positron emission tomography and transthoracic echocardiography', 'WMI', 'body weight']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302944', 'cui_str': '11C radioisotope'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.282477,Cardiac stroke work was preserved (-2 J; 95% CI -11 to 7; P = 0.69).,"[{'ForeName': 'Anders Hostrup', 'Initials': 'AH', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Nørrelund', 'Affiliation': 'Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars Poulsen', 'Initials': 'LP', 'LastName': 'Tolbod', 'Affiliation': 'Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hendrik Johannes', 'Initials': 'HJ', 'LastName': 'Harms', 'Affiliation': 'Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Feddersen', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Brøsen', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Nils Henrik', 'Initials': 'NH', 'LastName': 'Hansson', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Frøkiaer', 'Affiliation': 'Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Steen Hvitfeldt', 'Initials': 'SH', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sörensen', 'Affiliation': 'Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of heart failure,['10.1002/ejhf.1656']
787,30047376,"Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19).","BACKGROUND


More than 1·8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. A major limitation to date has been the lack of direct comparability between clinical trials and preclinical studies. We aimed to evaluate mosaic adenovirus serotype 26 (Ad26)-based HIV-1 vaccine candidates in parallel studies in humans and rhesus monkeys to define the optimal vaccine regimen to advance into clinical efficacy trials.
METHODS


We conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and gave boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 10 8  plaque-forming units per 0·5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein. Those in the control group received 0·9% saline. All study interventions were administered intramuscularly. Primary endpoints were safety and tolerability of the vaccine regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also assessed at week 52. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. We also did a parallel study in rhesus monkeys (NHP 13-19) to assess the immunogenicity and protective efficacy of these vaccine regimens against a series of six repetitive, heterologous, intrarectal challenges with a rhesus peripheral blood mononuclear cell-derived challenge stock of simian-human immunodeficiency virus (SHIV-SF162P3). The APPROACH trial is registered with ClinicalTrials.gov, number NCT02315703.
FINDINGS


Between Feb 24, 2015, and Oct 16, 2015, we randomly assigned 393 participants to receive at least one dose of study vaccine or placebo in the APPROACH trial. All vaccine regimens demonstrated favourable safety and tolerability. The most commonly reported solicited local adverse event was mild-to-moderate pain at the injection site (varying from 69% to 88% between the different active groups vs 49% in the placebo group). Five (1%) of 393 participants reported at least one grade 3 adverse event considered related to the vaccines: abdominal pain and diarrhoea (in the same participant), increased aspartate aminotransferase, postural dizziness, back pain, and malaise. The mosaic Ad26/Ad26 plus high-dose gp140 boost vaccine was the most immunogenic in humans; it elicited Env-specific binding antibody responses (100%) and antibody-dependent cellular phagocytosis responses (80%) at week 52, and T-cell responses at week 50 (83%). We also randomly assigned 72 rhesus monkeys to receive one of five different vaccine regimens or placebo in the NHP 13-19 study. Ad26/Ad26 plus gp140 boost induced similar magnitude, durability, and phenotype of immune responses in rhesus monkeys as compared with humans and afforded 67% protection against acquisition of SHIV-SF162P3 infection (two-sided Fisher's exact test p=0·007). Env-specific ELISA and enzyme-linked immunospot assay responses were the principal immune correlates of protection against SHIV challenge in monkeys.
INTERPRETATION


The mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine induced comparable and robust immune responses in humans and rhesus monkeys, and it provided significant protection against repetitive heterologous SHIV challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa (NCT03060629).
FUNDING


Janssen Vaccines & Prevention BV, National Institutes of Health, Ragon Institute of MGH, MIT and Harvard, Henry M Jackson Foundation for the Advancement of Military Medicine, US Department of Defense, and International AIDS Vaccine Initiative.",2018,"Env-specific ELISA and enzyme-linked immunospot assay responses were the principal immune correlates of protection against SHIV challenge in monkeys.
","['All participants who received at least one vaccine dose or', 'Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA', 'monkeys', 'Between Feb 24, 2015, and Oct 16, 2015, we randomly assigned 393 participants to receive at least one dose of study', 'rhesus monkeys (NHP 13-19', 'humans and rhesus monkeys', 'HIV (5', '72 rhesus monkeys to receive one of five different', 'healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection']","['vaccine or placebo', 'Ad26/Ad26', 'placebo', '0·9% saline', 'vaccine regimens or placebo', 'mosaic HIV-1 vaccine', 'mosaic adenovirus serotype 26 (Ad26)-based HIV-1', 'HIV or modified vaccinia Ankara (MVA; 10 8  plaque-forming units per 0·5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein']","['safety analysis; immunogenicity', 'immunogenicity and protective efficacy', 'magnitude, durability, and phenotype of immune responses', 'Safety and immunogenicity', 'vaccines: abdominal pain and diarrhoea', 'safety and tolerability of the vaccine regimens and Env-specific binding antibody responses', 'aspartate aminotransferase, postural dizziness, back pain, and malaise', 'favourable safety and tolerability']","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0001741', 'cui_str': 'East Africa'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0026447', 'cui_str': 'Monkeys'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0234987', 'cui_str': 'Dizziness on standing up (finding)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}]",393.0,0.67252,"Env-specific ELISA and enzyme-linked immunospot assay responses were the principal immune correlates of protection against SHIV challenge in monkeys.
","[{'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jetton', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'Korber', 'Affiliation': 'Theoretical Biology and Biophysics, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'Vaccine Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'Vaccine Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Project San Francisco, Rwanda-Zambia HIV Research Group, Kigali, Rwanda.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kibuuka', 'Affiliation': 'Makerere University Walter Reed Project, Kampala, Uganda.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mpendo', 'Affiliation': 'Uganda Virus Research Institute, International AIDS Vaccine Initiative HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Garrett', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Kundai', 'Initials': 'K', 'LastName': 'Chinyenze', 'Affiliation': 'International AIDS Vaccine Initiative, New York City, NY, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative, New York City, NY, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lazarus', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Nitayapan', 'Affiliation': 'Royal Thai Army, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'The Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University, Bangkok.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bart', 'Affiliation': 'Optimal Research, LLC, Rockville, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Miami Research Associates, Miami, FL, USA.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Lucksinger', 'Affiliation': 'Tekton Research, Austin, TX, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Borremans', 'Affiliation': 'Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Callewaert', 'Affiliation': 'Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Raphaele', 'Initials': 'R', 'LastName': 'Roten', 'Affiliation': 'Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Scheppler', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands; Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Weijtens', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Feddes-de Boer', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'van Manen', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vreugdenhil', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Infectious Diseases BV, Beerse, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Euler', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)31364-3']
788,29136115,Estradiol Levels Are Altered in Human Immunodeficiency Virus-Infected Pregnant Women Randomized to Efavirenz-Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy.,"Background


Combination antiretroviral therapy (cART) use in pregnancy has been associated with hormonal dysregulation. We performed a secondary retrospective analysis of longitudinal progesterone and estradiol levels in pregnancy using specimens from the Protease Inhibitors to Reduce Malaria Morbidity in HIV-infected Pregnant Women study, which randomized Ugandan human immunodeficiency virus (HIV)-infected ART-naive women to initiate either lopinavir/ritonavir (LPV/r)-based or efavirenz (EFV)-based cART.
Methods


Three hundred twenty-six women (160 randomized to the EFV arm and 166 women to the LPV/r arm) with at least 1 plasma sample collected during pregnancy were included. Enrollment samples collected prior to cART initiation were used as a cART-naive comparator group. Hormone levels were quantified by enzyme-linked immunosorbent assay.
Results


Estradiol levels were differentially affected by the 2 cART regimens. Exposure to LPV/r was associated with an increase in estradiol (P < .0001), whereas exposure to EFV was associated with a decrease in estradiol (P < .0001), relative to the cART-naive gestationally matched comparator group. Lower estradiol levels correlated with small for gestational age (SGA) (P = .0019) and low birth weight (P = .019) in the EFV arm, while higher estradiol levels correlated with SGA in the LPV/r arm (P = .027). Although progesterone levels were similar between treatment arms, we observed an association between SGA and lower progesterone in the LPV/r arm (P = .04). No association was observed between hormone levels and preterm birth in either arm. Levels of progesterone and estradiol were lower in cases of stillbirth, and levels of both hormones declined immediately prior to stillbirth in 5 of 8 cases.
Conclusions


Combination ART regimens differentially affect estradiol levels in pregnancy, a hormone critical to the maintenance of a healthy pregnancy. Identifying cART regimens that minimize perinatal HIV transmission without contributing to hormonal dysregulation represents an urgent public health priority.
Clinical Trials Registration


NCT00993031.",2018,"Lower estradiol levels correlated with small for gestational age (SGA) (P = .0019) and low birth weight (P = .019) in the EFV arm, while higher estradiol levels correlated with SGA in the LPV/r arm (P = .027).","['Methods\n\n\nThree hundred twenty-six women (160 randomized to the EFV arm and 166 women to the LPV/r arm) with at least 1 plasma sample collected during pregnancy were included', 'Human Immunodeficiency Virus-Infected Pregnant Women', 'HIV-infected Pregnant Women study, which randomized Ugandan human immunodeficiency virus (HIV)-infected ART-naive women to initiate either']","['\n\n\nCombination antiretroviral therapy (cART', 'Efavirenz-Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy', 'lopinavir/ritonavir (LPV/r)-based or efavirenz (EFV)-based cART', 'Protease Inhibitors']","['progesterone levels', 'low birth weight', 'estradiol', 'Hormone levels', 'estradiol levels', 'Levels of progesterone and estradiol', 'Lower estradiol levels', 'Malaria Morbidity', 'Estradiol levels', 'hormone levels and preterm birth', 'Estradiol Levels']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}]","[{'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",326.0,0.0527734,"Lower estradiol levels correlated with small for gestational age (SGA) (P = .0019) and low birth weight (P = .019) in the EFV arm, while higher estradiol levels correlated with SGA in the LPV/r arm (P = .027).","[{'ForeName': 'Chloe R', 'Initials': 'CR', 'LastName': 'McDonald', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Conroy', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Gamble', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Papp', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hawkes', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'University of Western Ontario, London, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, San Francisco.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Koss', 'Affiliation': 'Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Kain', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Serghides', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/cix772']
789,30006887,Action plan interrupted: resolution of proactive interference while coordinating execution of multiple action plans during sleep deprivation.,"The ability to retain an action plan to execute another is necessary for most complex, goal-directed behavior. Research shows that executing an action plan to an interrupting event can be delayed when it partly overlaps (vs. does not overlap) with the retained action plan. This phenomenon is known as partial repetition costs (PRCs). PRCs reflect proactive interference, which may be resolved by inhibitory, executive control processes. We investigated whether these inhibitory processes are compromised due to one night of sleep deprivation. Participants were randomized to a sleep-deprived group or a well-rested control group. All participants performed an action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group). In this task, two visual events occurred in a sequence. Participants retained an action plan to the first event in working memory while executing a speeded action to the second (interrupting) event; afterwards, they executed the action to the first event. The two action plans either partly overlapped (required the same hand) or did not (required different hands). Results showed slower responses to the interrupting event during sleep deprivation compared to baseline and the control group. However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group. Thus, one night of sleep deprivation slowed global responses to the interruption, but inhibitory processes involved in reducing proactive interference while responding to an interrupting event were not compromised. These findings are consistent with other studies that show sleep deprivation degrades global task performance, but does not necessarily degrade performance on isolated, executive control components of cognition. The possibility that our findings involve local as opposed to central inhibition is also discussed.",2020,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.",[],"['action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group', 'sleep-deprived group or a well-rested control group']",[],[],"[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0135948,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA. lfournier@wsu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Stubblefield', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}]",Psychological research,['10.1007/s00426-018-1054-z']
790,29985719,Bio-Electro-Magnetic-Energy-Regulation (BEMER) for the treatment of type I complex regional pain syndrome: A pilot study.,"Objective:  The study aimed to evaluate the efficacy of Bio-Electro-Magnetic-Energy-Regulation (BEMER) magneto-therapy on pain and functional outcome in complex regional pain syndrome type I (CRPS-I). We hypothesized that BEMER therapy, based on its declared effects on microcirculation, could be beneficial in the treatment of this condition.  Methods:  This was a randomized controlled double-blind pilot study that included 30 patients with CRPS-I. Patients were divided into two groups: a study group, in which the rehabilitation program was combined with BEMER therapy for 10 consecutive days, and a control group, in which the rehabilitation program was combined with a sham BEMER treatment. Outcome measures (Visual Analogic Scale pain; Hand Grip Strength; Disabilities of the Arm, Shoulder, and Hand ; Maryland Foot Score) were taken at the beginning and end of treatment, and at 1 month follow-up.  Results:  The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.  Conclusions:  Data from the present pilot study suggest that BEMER therapy can be indicated, in combination with traditional rehabilitation programs, for the treatment of CRPS-I.",2020,"The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.
","['30 patients with CRPS-I. Patients', 'type I complex regional pain syndrome', 'complex regional pain syndrome type']","['BEMER', 'Bio-Electro-Magnetic-Energy-Regulation (BEMER', 'rehabilitation program was combined with BEMER therapy', 'Bio-Electro-Magnetic-Energy-Regulation (BEMER) magneto-therapy']","['pain and functional outcome', 'Outcome measures (Visual Analogic Scale pain; Hand Grip Strength; Disabilities of the Arm, Shoulder, and Hand ; Maryland Foot Score', 'pain reduction and functional improvement both at the upper and lower limbs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034931', 'cui_str': 'CRPS Type I'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",30.0,0.0445093,"The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.
","[{'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Benedetti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cavazzuti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mosca', 'Affiliation': 'Orthopaedic and Traumatologic Clinic, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Fusaro', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zati', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1491661']
791,31619187,"A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis.","BACKGROUND


Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor currently being investigated as a treatment for anemia of chronic kidney disease (CKD) in both dialysis and nondialysis patients. In clinical studies to date, daprodustat has been administered orally as a once-daily regimen. This randomized, double-blind, placebo-controlled study characterized the initial dose-hemoglobin response as well as the efficacy and safety of three times weekly (TIW) daprodustat in hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule.
METHODS


103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5 g/dL and previously receiving a stable dose of rhEPO or its analogs were randomized 1:1:1:1:1 to receive daprodustat 10, 15, 25, or 30 mg or placebo TIW over 29 days.
RESULTS


Mean baseline hemoglobin was 10.6 g/dL for the placebo group and each daprodustat cohort. Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29. Using a Bayesian approach, the estimated dose conversion ratio between once-daily and TIW daprodustat was ~ 2.0 across the evaluated dose range using an E max  model. Daprodustat was generally well tolerated, with an adverse event (AE) profile consistent with the hemodialysis population.
CONCLUSIONS


These data help inform the appropriate dose conversion ratio to be applied to daily doses to obtain equivalent daprodustat TIW doses and suggest TIW treatment with daprodustat can treat anemia of CKD safely, supporting future long-term studies for this indication using a TIW dosing regimen.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02689206 ; date registered: 02/11/2016.",2019,Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29.,"['patients with anemia on hemodialysis', 'hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule', '103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5\u2009g/dL and previously receiving a stable dose of rhEPO or its analogs']","['placebo', 'placebo TIW']","['efficacy and safety', 'mean hemoglobin', 'Mean baseline hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",103.0,0.127547,Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29.,"[{'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Bailey', 'Affiliation': 'R&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA. christine.k.bailey@gsk.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caltabiano', 'Affiliation': 'R&D, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Cobitz', 'Affiliation': 'R&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'R&D, Clinical Statistics, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Mahar', 'Affiliation': 'R&D, Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Vickas V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'R&D, Discovery Medicine, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}]",BMC nephrology,['10.1186/s12882-019-1547-z']
792,31556651,Family-based prevention of adolescents' co-occurring internalizing/externalizing problems through early childhood parent factors.,"OBJECTIVE


We evaluated whether initiating the Family Check-Up (FCU) during early childhood prevented a severe form of psychopathology in adolescence-co-occurring internalizing and externalizing problems-and whether effects operated indirectly through early childhood maternal depression and parents' positive behavior support.
METHOD


Participants were drawn from a randomized controlled trial of the FCU (50.2% FCU; 49.5% girls; 46.6% Caucasian, and 27.6% Black; 13.4% Hispanic/Latino). At Ages 2 and 3, mothers self-reported depression, and primary caregivers' (PCs') positive behavior support was coded by trained observers. PCs, alternate caregivers (ACs), and teachers reported on 14-year-olds' problem behaviors. Latent profile analyses (LPAs) identified problem behavior groups for each reporter, which were outcomes in multinomial logistic regressions (PC, n = 672; AC, n = 652; teacher, n = 667).
RESULTS


LPAs identified a low-problem, internalizing-only, externalizing-only, and co-occurring-problem group for each reporter. For PC- and AC-reported outcomes, the FCU predicted a lower likelihood that adolescents belonged to the co-occurring group relative to the low-problem, externalizing-only (p < .05), and internalizing-only (p < .05 for PC, p < 0.10 for AC) groups; these effects operated through maternal depression (p < .05). For teacher-reported outcomes, the FCU predicted a lower likelihood that adolescents belonged to the co-occurring group relative to the low-problem, internalizing-only, and externalizing-only (p < 0.05) groups; effects operated through positive behavior support (p < 0.05).
CONCLUSIONS


Early delivery of the FCU indirectly prevented adolescents' co-occurring internalizing/externalizing problems in both home and school contexts by improving the quality of the early home environment. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"CONCLUSIONS


Early delivery of the FCU indirectly prevented adolescents' co-occurring internalizing/externalizing problems in both home and school contexts by improving the quality of the early home environment.","['Participants were drawn from a randomized controlled trial of the FCU (50.2% FCU; 49.5% girls; 46.6% Caucasian, and 27.6% Black; 13.4% Hispanic/Latino']",['Family Check-Up (FCU'],"[""PCs, alternate caregivers (ACs), and teachers reported on 14-year-olds' problem behaviors"", ""adolescents' co-occurring internalizing/externalizing problems""]","[{'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",2019.0,0.060179,"CONCLUSIONS


Early delivery of the FCU indirectly prevented adolescents' co-occurring internalizing/externalizing problems in both home and school contexts by improving the quality of the early home environment.","[{'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Feldman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000439']
793,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE


To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
RESEARCH DESIGN AND METHODS


Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study.
RESULTS


A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P  = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI.
CONCLUSIONS


Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993']
794,31520741,Interim monitoring in a treatment strategy trial with a composite primary endpoint.,"When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data evolve on multiple fronts. We illustrate with a study in the treatment of Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation. The study, ACTG-A5264/AMC-067, was a 1:1 randomized trial to compare two strategies: immediate initiation of etoposide with antiretroviral therapy (ART), or ART with delayed etoposide upon disease progression. The outcome was a composite endpoint that included the following events, ordered from worst to best in the following three categories: (1) KS progression at 48 weeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response at 48 weeks. We present the interim results on the composite endpoint and the individual components, where components favored different study arms at an interim review. To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint. We also recommend flexibility in the timing of data reviews by the DSMB to interpret emerging data in multiple dimensions. Clinicaltrials.govNCT01352117.",2019,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","['Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation']","['etoposide with antiretroviral therapy (ART), or ART with delayed etoposide']","['KS progression at 48\u202fweeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response']","[{'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0430354,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","[{'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: mkang@hsph.harvard.edu.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': 'School of Statistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glidden', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105846']
795,31860407,Prevention of Orbitopathy by Oral or Intravenous Steroid Prophylaxis in Short Duration Graves' Disease Patients Undergoing Radioiodine Ablation: A Prospective Randomized Control Trial Study.,"Background:  Radioiodine (RAI) is a known risk factor for activation or  de novo  occurrence of Graves' orbitopathy (GO). Several studies demonstrated that GO can be prevented by glucocorticoids (GCs) in patients with pre-existing GO. We have previously shown that Graves' disease duration (GDd) <5 years is a risk factor for RAI-induced GO. We studied the effect of prophylaxis with either oral GCs (OGCs) or intravenous GCs (IVGCs) on GO activation in patients with GDd.  Methods:  In total, 99 hyperthyroid patients without GO or with pre-existing inactive GO with GDd <5 years were randomized to receive IVGCs ( N  = 49) or OGCs ( N  = 50) before RAI; 22 patients with GDd >5 did not receive steroids and were studied as controls. All patients underwent ophthalmological assessment before and 45, 90, 180 days and for a 5-year follow-up after RAI. Serum thyrotropin (TSH) receptor antibodies (TRAbs), thyroid hormones, and thyroid volume (TV) were also measured in response to RAI therapy and steroid prophylaxis.  Results:  No patient on prophylaxis developed GO after RAI. One woman of the control group, without steroid prophylaxis, and who had a marked elevation of her TSH, showed transient reactivation of GO, which spontaneously improved after restoring euthyroidism. On follow-up at 12 and 20 months after RAI, two patients developed overt optic neuropathy. A smaller TV was associated with a higher prevalence of RAI-induced hypothyroidism. Serum TRAbs increased significantly after RAI ( p  < 0.0001) but less in patients receiving steroids than in those without prophylaxis at 45 days ( p  < 0.01).  Conclusions:  The risk of RAI-induced GO can be prevented in all patients with GDd <5 years by steroids. Such treatment may not be necessary in patients with GDd >5 years. The blunting of TRAb elevation after RAI may be related to the prophylactic effect of steroids.",2019,Serum TRAbs increased significantly after RAI ( p  < 0.0001) but less in patients receiving steroids than in those without prophylaxis at 45 days ( p  < 0.01).  ,"['99 hyperthyroid patients without GO or with pre-existing inactive GO with GDd <5 years', 'patients with GDd', 'patients with pre-existing GO', 'patients with GDd >5 years', ""Short Duration Graves' Disease Patients""]","['IVGCs ( N \u2009=\u200949) or OGCs', 'prophylaxis with either oral GCs (OGCs) or intravenous GCs (IVGCs', 'GDd >5 did not receive steroids', 'Radioiodine Ablation', 'Radioiodine (RAI', 'Orbitopathy by Oral or Intravenous Steroid Prophylaxis']","['Serum TRAbs', 'transient reactivation of GO', 'GO activation', 'Serum thyrotropin (TSH) receptor antibodies (TRAbs), thyroid hormones, and thyroid volume (TV', 'TRAb elevation', 'overt optic neuropathy', 'marked elevation of her TSH']","[{'cui': 'C0020550', 'cui_str': 'Hyperthyroid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0018213', 'cui_str': 'Graves Disease'}]","[{'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection (procedure)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0040139', 'cui_str': 'Thyroid-Stimulating Antibodies'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C3887709'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}]",,0.0145578,Serum TRAbs increased significantly after RAI ( p  < 0.0001) but less in patients receiving steroids than in those without prophylaxis at 45 days ( p  < 0.01).  ,"[{'ForeName': 'Guia', 'Initials': 'G', 'LastName': 'Vannucchi', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Istituto Auxologico Italiano IRCCS, Milan, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Covelli', 'Affiliation': ""Graves' Orbitopathy Center, Endocrinology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Campi', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Istituto Auxologico Italiano IRCCS, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Currò', 'Affiliation': 'Ophthalmology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Dazzi', 'Affiliation': 'Division of Internal Medicine, Ospedale Vaio, Fidenza, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Rodari', 'Affiliation': 'Department of Nuclear Medicine, Istituto Clinico Humanitas, Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Pepe', 'Affiliation': 'Department of Nuclear Medicine, Istituto Clinico Humanitas, Milan, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Chiti', 'Affiliation': 'Department of Nuclear Medicine, Istituto Clinico Humanitas, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Guastella', 'Affiliation': 'Department of Otolaryngology, University of Milan and Fondazione IRCCS Cà Granda, Milan, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Lazzaroni', 'Affiliation': ""Graves' Orbitopathy Center, Endocrinology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salvi', 'Affiliation': ""Graves' Orbitopathy Center, Endocrinology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0150']
796,31875756,Efficacy of the bispectral index and Observer's Assessment of Alertness/Sedation Scale in monitoring sedation during spinal anesthesia: A randomized clinical trial.,"OBJECTIVE


The bispectral index (BIS) has been used to monitor sedation during spinal anesthesia. We evaluated the correlation between BIS and the Observer's Assessment of Alertness/Sedation Scale (OAA/S) in patients sedated with dexmedetomidine, propofol, or midazolam.
METHODS


This prospective, randomized study included 46 patients scheduled for knee arthroplasty under spinal anesthesia with sedation. The patients were randomized to receive sedation with dexmedetomidine (n = 15), propofol (n = 15), or midazolam (n = 16). Correlation between BIS and OAA/S was assessed during sedation in the three groups.
RESULTS


A linear correlation was observed between BIS and OAA/S, and there was no significant difference in BIS score between the groups during mild to moderate sedation status (OAA/S 3-5). During deep sedation (OAA/S 1-2), the BIS score in the midazolam group was significantly higher than that in the propofol and dexmedetomidine groups (74.4 ± 11.9 vs 67.7 ±  9.5 vs 62.6 ± 12.2).
CONCLUSIONS


BIS values differed at the same level of sedation between different sedative agents. Objective sedation scores should therefore be used in combination with BIS values for the assessment of sedation levels during spinal anesthesia.",2020,,['monitoring sedation during spinal anesthesia'],"[""bispectral index and Observer's Assessment of Alertness/Sedation Scale""]",[],"[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}]",[],,0.0547372,,"[{'ForeName': 'Tae Wan', 'Initials': 'TW', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Yi Hwa', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jong Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Soo Kyung', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Youn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Jun Suck', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060519893165']
797,31862174,Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial.,"INTRODUCTION


The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown.
AIM


To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension.
METHODS


We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg).
MAIN OUTCOME MEASURE


The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years.
RESULTS


At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity.
CLINICAL IMPLICATIONS


The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude.
STRENGTH & LIMITATIONS


Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed.
CONCLUSION


In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.",2020,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","['men with hypertension, but without diabetes', 'men with hypertension', '1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk', 'Hypertensive Men']","['Intensive vs Standard Blood Pressure Treatment', 'intensive blood pressure control', 'intensive systolic blood pressure (SBP) lowering', 'intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg']","['erectile function', 'erectile function, testosterone, other androgen, and estrogen levels', '5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21', 'change in erectile function', 'incidence of ED', 'intensive blood pressure lowering', 'IIEF-5 score', 'cardiovascular events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1255.0,0.183276,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","[{'ForeName': 'Capri G', 'Initials': 'CG', 'LastName': 'Foy', 'Affiliation': 'Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: cfoy@wakehealth.edu.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Newman', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Greg B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, MA, and Boston University School of Medicine and Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': ""Michael E. DeBakey Veterans' Administration Medical Center, Houston, TX, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Burgner', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Thaddeus Y', 'Initials': 'TY', 'LastName': 'Carson', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Doumas', 'Affiliation': 'Second Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robin Y', 'Initials': 'RY', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Robert Wood Johnson Medical School, Rutgers University, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Peter van', 'Initials': 'PV', 'LastName': 'Buren', 'Affiliation': ""Department of Internal Medicine, Dallas Veterans' Administration Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.256']
798,31620939,"Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study.","OBJECTIVE


The aim of this 12-month mono-centre double-blind randomized placebo-controlled clinical study was to evaluate the efficacy of Lactobacillus reuteri-containing lozenges during the supportive therapy of generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients.
MATERIAL AND METHODS


Twenty treated GPIII-IVC patients were randomly divided into 2 groups. The test group received two 3-month-long administrations of L. reuteri (2 lozenges/day after brushing) with a 3-month washout period, while the control one received a placebo. Outcome measures were tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment. Measurements were collected at 3, 6, 9 and 12 months.
RESULTS


At 1 year, no dropout, tooth loss, complications or adverse event were recorded. Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
CONCLUSIONS


Within the limitation of the study, the use of L. reuteri probiotics lozenges improved some clinical outcomes in treated GPIII-IVC patients during maintenance therapy. Studies with a larger number of patients are needed to confirm these data.
CLINICAL RELEVANCE


The use of L. reuteri probiotic lozenges could be considered as an adjunct in the maintenance therapy of GPIII-IVC patients.",2020,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","['generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients', 'Twenty treated GPIII-IVC patients', 'GPIII-IVC patients', 'generalized periodontitis stage III and IV, grade C', 'treated GPIII-IVC patients during maintenance therapy']","['placebo', 'L. reuteri probiotic lozenges', 'Lactobacillus reuteri-containing lozenges']","[""tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment"", 'BOP reduction', 'dropout, tooth loss, complications or adverse event', 'PAL gain', 'Mean PPD and mean PAL and percentages of sites with BOP', 'PPD reduction']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441807', 'cui_str': 'Grade C (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080233', 'cui_str': 'Tooth Loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",,0.306097,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","[{'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Grusovin', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy. Gabri.grusovin@tiscali.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bossini', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Cappa', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Garzetti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Eleonara', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Enrico Felice', 'Initials': 'EF', 'LastName': 'Gherlone', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Mensi', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}]",Clinical oral investigations,['10.1007/s00784-019-03065-x']
799,29284111,Digoxin Benefit Varies by Risk of Heart Failure Hospitalization: Applying the Tufts MC HF Risk Model.,"BACKGROUND


Digoxin has been shown to reduce heart failure hospitalizations with a neutral effect on mortality. It is unknown whether there is heterogeneity of treatment effect for digitalis therapy according to predicted risk of heart failure hospitalization.
METHODS AND RESULTS


We conducted a post hoc analysis of the Digitalis Investigator Group (DIG) studies, randomized controlled trials of digoxin vs placebo in participants with heart failure and left ventricular ejection fraction ≤45% (main DIG study, n = 6800) or >45% (ancillary DIG study, n = 988). Using a previously derived multistate model to risk-stratify DIG study participants, we determined the differential treatment effect on hospitalization and mortality outcomes. There was a 13% absolute reduction in the risk of any heart failure hospitalizations (39% vs 52%; odds ratio 0.58; 95% confidence interval 0.47-0.71) in the digoxin vs placebo arms in the highest-risk quartile, compared with a 3% absolute risk reduction for any heart failure hospitalization (17% vs 20%; odds ratio 0.84; 95% confidence interval, 0.66-1.08) in the lowest-risk quartile. There were 12 fewer total all-cause hospitalizations per 100 person-years in the highest-risk quartile compared with an increase of 8 hospitalizations per 100 person-years in the lowest-risk quartile. There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
CONCLUSIONS


Participants in the DIG study at higher risk of hospitalization as identified by a multistate model were considerably more likely to benefit from digoxin therapy to reduce heart failure hospitalization.",2018,"There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
","['participants with heart failure and left ventricular ejection fraction ≤45% (main DIG study, n\xa0']","['placebo', 'Digoxin', 'digoxin vs placebo', 'digoxin', 'digoxin therapy']","['hospitalization and mortality outcomes', 'heart failure hospitalization', 'risk of any heart failure hospitalizations']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C3181833', 'cui_str': 'Dig(dhd)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.273566,"There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
","[{'ForeName': 'Jenica N', 'Initials': 'JN', 'LastName': 'Upshaw', 'Affiliation': 'The CardioVascular Center, Tufts Medical Center, Boston, Mass. Electronic address: jupshaw@tuftsmedicalcenter.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Mass; The Medical Statistics Department, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center, Tufts Medical Center, Boston, Mass.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Mass.'}]",The American journal of medicine,['10.1016/j.amjmed.2017.12.010']
800,29265999,A novel peer-support intervention using motivational interviewing for breastfeeding maintenance: a UK feasibility study.,"BACKGROUND


In total, 81% of women in the UK start breastfeeding, but fewer than half continue beyond 6 weeks. Peer support in the early postnatal period may encourage women to breastfeed for longer.
OBJECTIVE


To develop a breastfeeding peer-support intervention based on motivational interviewing (MI) for breastfeeding maintenance and to test the feasibility of delivering it to mothers in areas with high levels of social deprivation.
DESIGN


Intervention development and a non-randomised multisite feasibility study.
SETTING


Community maternity services in three areas with high levels of social deprivation and low breastfeeding initiation rates in England and Wales.
PARTICIPANTS


Pregnant women considering breastfeeding. Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded.
INTERVENTION


The intervention Mam-Kind was informed by a survey of infant feeding co-ordinators, rapid literature review, focus groups with service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group. It consisted of face-to-face contact at 48 hours after birth and proactive one-to-one peer support from the Mam-Kind buddy for 2 weeks, followed by mother-led contact for a further 2-6 weeks.
MAIN OUTCOME MEASURES


Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals.
RESULTS


Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study). Participants were aged between 19 and 41 years and 94% of participants were white. Intervention uptake was 75% and did not vary according to age or parity. Most contacts (79%) were initiated by the buddy, demonstrating the intended proactive nature of the intervention and 73% ( n  = 51) of participants received a contact within 48 hours. Follow-up data were available for 78% of participants at 10 days and 64% at 8 weeks. Data collection methods were judged feasible and acceptable. Data completeness was > 80% for almost all variables. Interviews with participants, buddies and health service professionals showed that the intervention was acceptable. Buddies delivered the intervention content with fidelity (93% of intervention objectives were met), and, in some cases, developed certain MI skills to a competency level. However, they reported difficulties in changing from an information-giving role to a collaborative approach. These findings were used to refine the training and intervention specification to emphasise the focus of the intervention on providing mother-centric support. Health-care professionals were satisfied that the intervention could be integrated with existing services.
CONCLUSIONS


The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial. The feasibility study highlighted the need to strengthen strategies for birth notification and retention of participants, and provided some insights on how this could be achieved in a full trial.
LIMITATIONS


The response rate to the survey of infant feeding co-ordinators was low (19.5%). In addition, the women who were recruited may not be representative of the study sites.
FUNDING


The National Institute for Health Research Health Technology Assessment programme.",2017,The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial.,"['mothers in areas with high levels of social deprivation', 'women who were recruited may not be representative of the study sites', 'Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study', 'Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded', 'Community maternity services in three areas with high levels of social deprivation and low breastfeeding initiation rates in England and Wales', 'Participants were aged between 19 and 41 years and 94% of participants were white', 'Pregnant women considering breastfeeding']","['novel peer-support intervention using motivational interviewing', 'breastfeeding peer-support intervention based on motivational interviewing (MI', 'service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group']","['Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals', 'response rate', 'Intervention uptake']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",9.0,0.0787728,The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial.,"[{'ForeName': 'Shantini', 'Initials': 'S', 'LastName': 'Paranjothy', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Merrett', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Grant', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Hunter', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Involving People Network, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Public Health, Policy and Social Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Tedstone', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Trickey', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta21770']
801,29168127,Bioavailability of Orally Administered Des-Aspartate-Angiotensin I in Human Subjects.,"In an earlier single-dose escalation study to evaluate the safety and pharmacokinetics of orally administered des-aspartate-angiotensin I (DAA-I) in healthy subjects, the plasma level of DAA-I could not be determined because DAA-I is rapidly degraded in the circulation. The present study investigated the oral bioavailability of DAA-I by measuring the prostaglandin E 2  metabolite (PGEM) in the plasma samples of the same trial. PGEM is a stable derivative of PGE 2 , which has been shown to be a biomarker of DAA-I. The data show that plasma from two of the three subjects who were orally administered the efficacious preclinical dose of 0.70 mg/kg DAA-I exhibited a significant PGEM peak at 5-6 h postdose. Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak. This observation is concordant with the known in vivo actions of DAA-I, especially its hypoglycemic action where maximum efficacy occurred at a dose of 0.7 mg/kg, and decreased to nil at the two-times efficacious dose. The onset of the PGEM peak at 5-6 h postdose was closed to the 4-h onset of absorption of [C 14 ]DAA-I seen in preclinical rat studies, albeit the absorption kinetics between rodents and humans are not identical. The occurrence of polymorphism of enzymes involved in the formation and degradation of PGE 2  is common, and this has been attributed to contributing to the variation in response, onset and peak PGEM observed among the three subjects who were administered the efficacious dose.",2018,"Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak.","['healthy subjects', 'I in Human Subjects']","['Bioavailability of Orally Administered Des-Aspartate-Angiotensin', 'orally administered des-aspartate-angiotensin I (DAA-I', 'PGEM']",['PGEM peak'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C2354314', 'cui_str': 'des-aspartate-angiotensin I'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.0452657,"Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak.","[{'ForeName': 'Kok-Onn', 'Initials': 'KO', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block Level 10, Singapore, 119228, Singapore.'}, {'ForeName': 'Edmund Feng', 'Initials': 'EF', 'LastName': 'Tian', 'Affiliation': 'School of Applied Science, Temasek Polytechnic, 21 Tampines Avenue 1, Singapore, 529757, Singapore.'}, {'ForeName': 'Martin Hui', 'Initials': 'MH', 'LastName': 'Cai', 'Affiliation': 'School of Applied Science, Temasek Polytechnic, 21 Tampines Avenue 1, Singapore, 529757, Singapore.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Singapore Nuclear Research and Safety Initiative, National University of Singapore, 1 CREATE Way, #04-01 CREATE Tower, Singapore, 138602, Singapore.'}, {'ForeName': 'Yiong-Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, 1E Kent Ridge Road, NUHS Tower Block Level 11, Singapore, 119228, Singapore.'}, {'ForeName': 'Meng-Kwoon', 'Initials': 'MK', 'LastName': 'Sim', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, Block MD 3 Level 4 #04-01, 16 Medical Drive, Singapore, 117600, Singapore. simmk@alumni.nus.edu.sg.'}]",Drugs in R&D,['10.1007/s40268-017-0218-4']
802,31670874,Effectiveness of blood pressure-lowering treatment by the levels of baseline Framingham risk score: A post hoc analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).,"This was a post hoc analysis of Systolic Blood Pressure Intervention Trial (SPRINT), aimed to investigate whether intensive blood pressure treatment has differential therapeutic outcomes on patients with different baseline Framingham risk score (FRS). The 9298 SPRINT participants were categorized into low-risk (baseline FRS < 10%), intermediate-risk (FRS = 10%-20%), or high-risk (FRS > 20%) arms. The primary outcome was a composite of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes. Serious adverse events were defined as hypotension, syncope, and bradycardia. Multiple Cox regression was used to calculate hazard ratios for study outcomes with intensive compared with standard SBP treatment between these three groups. After a median follow-up time of 3.26 years, the primary outcome hazard ratio (HR) for intensive versus standard treatment was 0.73 (95% CI: 0.61-0.88, P = .0044) in the high-risk arm. And, for all-cause mortality, the hazard ratio with intensive SBP treatment was 1.58 (95% CI: 0.55-1.06), 0.9 (95% CI: 0.26-9.50), and 0.53 (95% CI: 0.34-0.82) in three arms (all P values for interaction > 0.05). Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS. Our results suggested that regardless of the FRS level, the intensive blood pressure control was beneficial.",2019,Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS.,"['patients with different FRS', '9298 SPRINT participants were categorized into low-risk (baseline FRS', 'patients with different baseline Framingham risk score (FRS']","['intensive versus standard SBP control', 'blood pressure-lowering treatment', 'intensive blood pressure treatment']","['intermediate-risk', 'hypotension, syncope, and bradycardia', 'composite of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.199312,Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS.,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatrics, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiuting', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Higher Education Mega Center, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Shaozhao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13720']
803,31613320,Effect of Dosage of 17ß-Estradiol on Uterine Growth in Turner Syndrome-A Randomized Controlled Clinical Pilot Trial.,"CONTEXT


Most Turner syndrome (TS) girls need exogenous estrogen treatment to induce puberty and normal uterine growth. After puberty, the optimal estrogen treatment protocol has not been determined.
OBJECTIVE


To compare 2 doses of oral 17ß-estradiol on uterine size.
DESIGN


A double-blind, 5-year randomized controlled clinical trial.
SETTING


Ambulatory care.
PARTICIPANTS


Twenty young TS women (19.2 ± 2.5 years, range 16.0-24.9) participated. Sixteen patients completed the study. No patients withdrew due to adverse effects.
INTERVENTION


The lower dose (LD) group took 2 mg 17ß-estradiol/d orally and placebo. The higher dose (HD) group took 4 mg 17ß-estradiol/d orally.
MAIN OUTCOME MEASURE(S)


Uterine volume evaluated by transabdominal ultrasound yearly.
RESULTS


Uterine size increased significantly more in the HD group compared with the LD group (P = 0.038), with a gain in uterine volume within the first 3 years of treatment of 19.6 mL (95% confidence interval [CI] = 4.0-19.0) in the HD group compared with 11.5 mL (95% CI = 11.2-27.9) in the LD group. The difference in 3-year gain was 8.1 mL (95% CI = 0.7-15.9). At the last visit, there were no significant differences in uterine volume between the groups.
CONCLUSION


HD oral 17ß-estradiol induces a steeper increase in uterine volume within the first years of treatment compared with the LD. However, the uterine growth potential seems to be the same in most young TS women making the duration of treatment equally significant as estrogen dose, although a few TS women did not experience sufficient uterine growth on 2 mg of estradiol.
CLINICALTRIALS.GOV


NCT00134745Abbreviations: BMI, body mass index; BSA, body surface area; DHEAS, dihydroepiandrosteronesulfate; HD, higher dose; HRT, hormone replacement therapy; LD, lower dose; TS, Turner syndrome; US, ultrasound.",2020,"RESULTS


Uterine size increased significantly more in the HD group compared to the LD group (P=0.038), with a gain in uterine volume within the first three years of treatment of 19.6 ml (95% CI = [4.0; 19.0]) in the HD group compared to 11.5 ml (95% CI = [11.2; 27.9]) in the LD group.","['Ambulatory care', 'Turner syndrome ', '16 patients completed the study', '20 young TS women (19.2±2.5 years, range 16.0-24.9) participated']","['placebo', '17ß-estradiol', 'oral 17ß-estradiol']","['Uterine size', 'gain in uterine volume', 'uterine growth', 'uterine volume']","[{'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0041408', 'cui_str': 'Ullrich-Turner Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",20.0,0.292607,"RESULTS


Uterine size increased significantly more in the HD group compared to the LD group (P=0.038), with a gain in uterine volume within the first three years of treatment of 19.6 ml (95% CI = [4.0; 19.0]) in the HD group compared to 11.5 ml (95% CI = [11.2; 27.9]) in the LD group.","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Cleemann', 'Affiliation': 'Department of Pediatrics, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Department of Pediatrics, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fallentin', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nini', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Kristensen', 'Affiliation': 'Department of Radiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Sven O', 'Initials': 'SO', 'LastName': 'Skouby', 'Affiliation': 'Department of Gynecology and Obstetrics, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Leth-Esbensen', 'Affiliation': 'Department of Radiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Pediatrics, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Andreas K', 'Initials': 'AK', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Research, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Claus H', 'Initials': 'CH', 'LastName': 'Gravholt', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus C, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz061']
804,31617896,Quality of life predicting long-term outcomes in cardiac resynchronization therapy patients.,"AIMS


While improvement in quality of life (QoL) has been widely reported in cardiac resynchronization therapy (CRT) patients, its predictive value is not well-understood. We aimed to assess the predictive role of baseline QoL on long-term heart failure (HF) or death events in mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT).
METHODS AND RESULTS


A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ). Kaplan-Meier survival analyses and multivariate Cox models were utilized. Issues within any of the domains of the baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were associated with long-term mortality (median follow-up 5.6 years) (all P < 0.05). Heart failure or death events were predicted by issues in baseline mobility [hazard ratio (HR) = 1.41, P < 0.001], usual activities (HR = 1.41, P < 0.001), and anxiety/depression (HR = 1.21, P = 0.035). The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003). Every 10% increase in the visual analogue scale (0-100) was associated with an 8% lower risk of all-cause mortality (P = 0.006), and a 6% lower risk of HF/death (P = 0.002). Mobility issues also predicted echocardiographic reverse remodelling (-33.08 mL vs. -31.17 mL, P = 0.043). Using the KCCQ, patients in the lower tertile of the clinical summary or physical limitations score had a significantly higher risk of long-term HF or death (P < 0.05).
CONCLUSION


In mild HF patients enrolled in MADIT-CRT, multiple baseline QoL questionnaire domains were predictors of echocardiographic remodelling, long-term all-cause mortality, and HF events.",2019,"The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003).","['cardiac resynchronization therapy patients', 'A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ', 'mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with']",['Cardiac Resynchronization Therapy (MADIT-CRT'],"['usual activity', 'usual activities', 'risk of HF/death', 'risk of long-term HF or death', 'Quality of life predicting long-term outcomes', 'risk of HF events alone', 'quality of life (QoL', 'long-term mortality', 'baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression', 'anxiety/depression', 'Heart failure or death events', 'visual analogue scale']","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",1820.0,0.125056,"The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003).","[{'ForeName': 'Klaudia Vivien', 'Initials': 'KV', 'LastName': 'Nagy', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Geller', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Kosztin', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz262']
805,31608926,"Efficacy, Safety, and Mechanistic Insights of Cotadutide, a Dual Receptor Glucagon-Like Peptide-1 and Glucagon Agonist.","CONTEXT


Cotadutide is a dual receptor agonist with balanced glucagon-like peptide-1 and glucagon activity.
OBJECTIVE


To evaluate different doses of cotadutide and investigate underlying mechanisms for its glucose-lowering effects.
DESIGN/SETTING


Randomized, double-blind, phase 2a study conducted in 2 cohorts at 5 clinical trial sites.
PATIENTS


Participants were 65 adult overweight/obese patients with type 2 diabetes mellitus; 63 completed the study; 2 were withdrawn due to AEs.
INTERVENTION


Once-daily subcutaneous cotadutide or placebo for 49 days. Doses (50-300 µg) were uptitrated weekly (cohort 1) or biweekly (cohort 2).
MAIN OUTCOME MEASURES


Co-primary end points (cohort 1) were percentage changes from baseline to end of treatment in glucose (area under the curve from 0 to 4 hours [AUC0-4h]) post-mixed-meal tolerance test (MMTT) and weight. Exploratory measures included postprandial insulin and gastric emptying time (GET; cohort 2).
RESULTS


Patients received cotadutide (cohort 1, n = 26; cohort 2, n = 20) or placebo (cohort 1, n = 13; cohort 2, n = 6). Significant reductions were observed with cotadutide vs placebo in glucose AUC0-4h post MMTT (least squares mean [90% CI], -21.52% [-25.68, -17.37] vs 6.32% [0.45, 12.20]; P < 0.001) and body weight (-3.41% [-4.37, -2.44] vs -0.08% [-1.45, 1.28]; P = 0.002). A significant increase in insulin AUC0-4h post MMTT was observed with cotadutide (19.3 mU.h/L [5.9, 32.6]; P = 0.008) and GET was prolonged on day 43 with cotadutide vs placebo (t½: 117.2 minutes vs -42.9 minutes; P = 0.0392).
CONCLUSION


These results suggest that the glucose-lowering effects of cotadutide are mediated by enhanced insulin secretion and delayed gastric emptying.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03244800.",2020,"Significant reductions were observed with cotadutide vs placebo in glucose AUC0-4h post MMTT (LS mean [90% CI]: -21.52% [-25.68, -17.37] vs 6.32% [0.45, 12.20]; P<0.001) and body weight (-3.41% [-4.37, -2.44] vs -0.08% [-1.45, 1.28]; P=0.002).","['65 adult overweight/obese patients with type 2 diabetes mellitus; 63 completed the study; 2 were withdrawn due to AEs', 'Patients received cotadutide (cohort 1, n=26; cohort 2, n=20) or', 'Randomized, double-blind, phase 2a study conducted in two cohorts at five clinical trial sites']","['placebo', 'cotadutide a dual receptor glucagon-like peptide-1 and glucagon agonist']","['Efficacy, safety', 'insulin AUC0-4h post MMTT', 'insulin secretion and delayed gastric emptying', 'glucose AUC0-4h post-mixed-meal tolerance test (MMTT) and weight', 'body weight', 'postprandial insulin and gastric emptying time (GET; cohort 2']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",65.0,0.669969,"Significant reductions were observed with cotadutide vs placebo in glucose AUC0-4h post MMTT (LS mean [90% CI]: -21.52% [-25.68, -17.37] vs 6.32% [0.45, 12.20]; P<0.001) and body weight (-3.41% [-4.37, -2.44] vs -0.08% [-1.45, 1.28]; P=0.002).","[{'ForeName': 'Victoria E R', 'Initials': 'VER', 'LastName': 'Parker', 'Affiliation': 'AstraZeneca, Cambridge, England, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Robertson', 'Affiliation': 'AstraZeneca, Cambridge, England, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hornigold', 'Affiliation': 'AstraZeneca, Cambridge, England, UK.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Petrone', 'Affiliation': 'AstraZeneca, Cambridge, England, UK.'}, {'ForeName': 'Aidan T', 'Initials': 'AT', 'LastName': 'Cooper', 'Affiliation': 'AstraZeneca, Cambridge, England, UK.'}, {'ForeName': 'Maximilian G', 'Initials': 'MG', 'LastName': 'Posch', 'Affiliation': 'Charite Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Moerschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schlichthaar', 'Affiliation': 'SMO.MD, Magdeburg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Klaus', 'Affiliation': 'Nuvisan Pharma Services, Ulm, Germany.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Ambery', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'St Josef-Hospital, Ruhr-University, Bochum, Germany.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Hirshberg', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz047']
806,31625480,"First-in-Human Study of the Safety, Tolerability, Pharmacokinetics and - Preliminary Dynamics of Neuroprotectant 2-Iminobiotin in Healthy Subjects.","BACKGROUND


2-iminobiotin (2-IB) is an investigational neuroprotective agent in development for the reduction of brain cell injury after cerebral hypoxia-ischemia.
OBJECTIVE


The present first-in-human study evaluated the safety, tolerability, pharmacokinetics (PK) and -dynamics (PD) of 2-IB in healthy male subjects, intravenously infused with or without Captisol® as a solubilizing agent.
METHODS


This randomized, double-blind, placebo-controlled, dose-escalation study was executed in 2 groups of 9 healthy male subjects. A single dose of 2-IB 0.6 mg/kg or placebo was infused over periods between 15 min and 4 h, and repeated doses escalating from 0.6 mg/kg to 12 mg/kg, or placebo were infused every 4 h for 6 administrations in total.
RESULTS


Single and multiple doses of 2-IB up to 6 doses of 6 mg/kg with and without Captisol® were safe and well-tolerated in healthy male subjects. 2-IB proved to be a high-clearance drug with a volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not to be affected by the presence of Captisol®.
CONCLUSION


Sulfobutyletherbeta-cyclodextrin (SBECD) in Captisol® had a low-clearance profile with a small volume of distribution, with time-independent PK. Preliminary PD characterization of repeated iv dosing of 2-IB in an acute peripheral hypoxic ischemia model in healthy subjects did not reveal any notable effects of 2-IB, noting that this model was not selected to guide efficacy in the currently pursued indication of cerebral hypoxia-ischemia.",2020,"2-IB proved to be a high-clearance drug with volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not be affected by presence of Captisol®.","['Healthy Subjects', '2 groups of 9 healthy male subjects', 'healthy subjects', 'healthy male subjects']","['placebo', '2-IB 0.6 mg/kg or placebo', 'Sulfobutylether-beta-cyclodextrin (SBECD', 'intravenously infused with or without Captisol® as solubilizing agent']","['safety, tolerability, pharmacokinetics (PK) and -dynamics', 'Safety, Tolerability, Pharmacokinetics', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0053407', 'cui_str': 'betadex'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.146719,"2-IB proved to be a high-clearance drug with volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not be affected by presence of Captisol®.","[{'ForeName': 'Ewoud-Jan', 'Initials': 'EJ', 'LastName': 'van Hoogdalem', 'Affiliation': 'Scientific Affairs - Clinical Pharmacology, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Cacha M P C D', 'Initials': 'CMPCD', 'LastName': 'Peeters-Scholte', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Paul W T J', 'Initials': 'PWTJ', 'LastName': 'Leufkens', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartstra', 'Affiliation': 'Early Development Services, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'van Lier', 'Affiliation': 'Early Development Services, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Leo G J', 'Initials': 'LGJ', 'LastName': 'de Leede', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}]",Current clinical pharmacology,['10.2174/1574884714666191017111109']
807,31476260,Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.,"AIMS


The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial.
METHODS AND RESULTS


At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 2  or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30).
CONCLUSIONS


In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.",2019,"All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50).","['patients with severe secondary mitral regurgitation', 'group, n=152', 'symptomatic patients with severe secondary mitral regurgitation, percutaneous repair', '304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20\u2009mm 2  or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo']","['percutaneous valve repair plus medical treatment (intervention group, n=152) or medical treatment alone (control', 'Percutaneous Repair or Medical Treatment']","['cause death and unplanned hospitalization for heart failure', 'risk of death or hospitalization for heart failure', 'All-cause mortality', 'composite of all-cause death and unplanned hospitalization for heart failure', 'Unplanned hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",304.0,0.156814,"All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50).","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Iung', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Armoiry', 'Affiliation': 'Pharmacy Department and Laboratoire MATEIS, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Vahanian', 'Affiliation': 'APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure Department, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Trochu', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Jacques Cartier, Massy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messika-Zeitoun', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Guerin', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cormier', 'Affiliation': 'Institut Jacques Cartier, Massy, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brochet', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': 'Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Himbert', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Thivolet', 'Affiliation': 'Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Leurent', 'Affiliation': 'CHU Rennes, Hôpital Pontchaillou, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bonnet', 'Affiliation': 'APHM, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'CHU Rennes, Hôpital Pontchaillou, Rennes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piriou', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Piot', 'Affiliation': 'Clinique du Millénaire, Montpellier, France.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Habib', 'Affiliation': 'APHM, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rouleau', 'Affiliation': 'CHU Angers, Angers, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'CHU Toulouse, Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Nejjari', 'Affiliation': 'Centre Cardiologique du Nord, Saint-Denis, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ohlmann', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint Etienne', 'Affiliation': 'CHRU de Tours, Hôpital Trousseau, Tours, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Leroux', 'Affiliation': 'CHU Bordeaux, Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'CHRU Brest, Hôpital de La Cavale Blanche, Brest, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Samson', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure Department, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rioufol', 'Affiliation': ""Hopital Cardiovasculaire Louis Pradel, Service d'Hémodynamique et Cardiologie Interventionnelle, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Obadia', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1616']
808,31409486,Measurements of adiposity as prognostic biomarkers for survival with anti-angiogenic treatment in epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group ancillary data analysis of GOG 218.,"OBJECTIVE


Adiposity has been hypothesized to interfere with the activity of bevacizumab (BEV), an anti-angiogenic agent. Measurements of adiposity, BMI, surface fat area (SFA), and visceral fat area (VFA) were investigated as prognostic of oncologic outcomes among patients treated with chemotherapy, with or without BEV, on GOG 218, a prospective phase III trial.
METHOD


Pretreatment computed tomography (CT) for 1538 GOG 218 participants were analyzed. Proportional hazards models assessed association between adiposity and overall survival (OS) adjusted for other prognostic factors. The predictive value of adiposity as a function of BEV treatment was assessed in 1019 patients randomized to either chemotherapy (CT) + placebo (P) → P or CT + BEV → BEV.
RESULTS


After adjusting for prognostic factors, SFA was not associated with the overall hazard of death (p = 0.981). There was a non-significant 0.1% (p = 0.062) increase in hazard of death associated with a unit increase in VFA. When comparing the treatment HRs for patients who did and did not receive BEV, there was no association with SFA (p = 0.890) or VFA (p = 0.106). A non-significant 0.8% increase in the hazard of death with unit increase in BMI (p = 0.086) was observed. BMI values were not predictive of a longer survival for patients with BEV vs placebo (p = 0.606).
CONCLUSION


Measures of adiposity strongly correlated to one another but were not predictive of efficacy for BEV. VFA is a weak prognostic factor.",2019,"BMI values were not predictive of a longer survival for patients with BEV vs placebo (p = 0.606).
","['epithelial ovarian cancer', '1538 GOG 218 participants were analyzed', '1019 patients randomized to either']","['placebo', 'Pretreatment computed tomography (CT', 'chemotherapy (CT)\u202f+\u202fplacebo (P)\u202f→\u202fP or CT', 'VFA', 'bevacizumab (BEV']","['hazard of death', 'BMI', 'VFA', 'adiposity, BMI, surface fat area (SFA), and visceral fat area (VFA', 'BMI values', 'overall hazard of death', 'adiposity', 'adiposity and overall survival (OS']","[{'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",218.0,0.0545987,"BMI values were not predictive of a longer survival for patients with BEV vs placebo (p = 0.606).
","[{'ForeName': 'K N Slaughter', 'Initials': 'KNS', 'LastName': 'Wade', 'Affiliation': 'The University of Oklahoma, Oklahoma City, OK, USA. Electronic address: Katrina.wade@ochsner.org.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': 'NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, University of Buffalo, Buffalo, NY, USA. Electronic address: BradyM@NRGOncology.org.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Thai', 'Affiliation': 'The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: Theresa-thai@ouhsc.edu.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The University of Oklahoma, Norman, OK, USA. Electronic address: Yunzhi.Wang-1@ou.edu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'The University of Oklahoma, Norman, OK, USA. Electronic address: bin.Zheng-1@ou.edu.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'The Ohio State University, James Cancer Hospital, Columbus, OH, USA. Electronic address: ritu.salani@osumc.edu.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'UC Irvine Medical Center, Orange, CA, USA. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Gray', 'Affiliation': 'University of Washington Medical Center, Seattle, WA, USA. Electronic address: hgray@uw.edu.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Bakkum-Gamez', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: bakkum.jamie@mayo.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. Electronic address: burgerr@uphs.upenn.edu.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'The University of Oklahoma, Oklahoma City, OK, USA. Electronic address: Kathleen-moore@ouhsc.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bookman', 'Affiliation': 'US Oncology Research and Arizona Oncology, Tucson, AZ, USA. Electronic address: Michael.a.bookman@kp.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.07.020']
809,28820855,Resistance exercise order does not affect the magnitude and duration of post-exercise blood pressure in older women.,"The aim of this study was to compare the effects of two resistance exercise order on post-exercise blood pressure (BP) in trained, non-hypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise. Blood pressure and heart rate were obtained pre and post-sessions (60 min). Post-exercise hypotension was observed for systolic and mean BP in both the MS session (systolic BP: -6.9 mmHg, mean BP: -3.3 mmHg, P< 0.05) and SM session (systolic BP: -4.6 mmHg; mean BP: -1.1 mmHg). Post-exercise heart rate was higher than pre-session values until 30 min of recovery in both training sessions. Furthermore, systolic and mean blood pressure, and heart rate were lower than the values obtained in the control session (30 to 60 min and 0 min, respectively; P<0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of post-exercise hypotension in trained, non-hypertensive older women.",2017,There were no differences between the SM and MS sessions in any variable or at any moment.,"['Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two', 'trained, non-hypertensive older women', 'older women', 'hypertensive older women']","['resistance exercise order on post-exercise blood pressure (BP', 'Resistance exercise', 'sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise']","['Post-exercise heart rate', 'Furthermore, systolic and mean blood pressure, and heart rate', 'Blood pressure and heart rate', 'magnitude and duration of post-exercise blood pressure', 'systolic and mean BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0338416,There were no differences between the SM and MS sessions in any variable or at any moment.,"[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'a Metabolism, Nutrition, and Exercise Laboratory. Londrina State University. Londrina, Brazil. b Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil. c Department of Physical Education, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil. d Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gerage', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': ''}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': ''}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177']
810,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
811,31540611,Sleep reductions associated with illicit opioid use and clinic-hour changes during opioid agonist treatment for opioid dependence: Measurement by electronic diary and actigraphy.,"Sleep problems are commonly reported during opioid agonist treatment (OAT) for opioid use disorders. Inpatient studies have found both sleep disturbances and improved sleep during OAT. Illicit opioids can also disrupt sleep, but it is unclear how they affect sleep in outpatients receiving OAT. Therefore, we used electronic diary entries and actigraphy to measure sleep duration and timing in opioid-dependent participants (n = 37) treated with methadone (n = 15) or buprenorphine (n = 22). For 16 weeks, participants were assigned to attend our clinic under different operating hours in a crossover design: Early hours (07:00-09:00) vs. Late hours (12:00-13:00) for 4 weeks each in randomized order, followed for all participants by our Standard clinic hours (07:00-11:30) for 8 weeks. Throughout, participants made daily electronic diary self-reports of their sleep upon waking; they also wore a wrist actigraph for 6 nights in each of the three clinic-hour conditions. Drug use was assessed by thrice-weekly urinalysis. In linear mixed models controlling for other sleep-relevant factors, sleep duration and timing differed by drug use and by clinic hours. Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine. Participants slept less and woke earlier when assigned to the Early hours. These findings highlight the role OAT clinic schedules can play in structuring the sleep/wake cycles of OAT patients and clarify some of the circumstances under which OAT patients experience sleep disruption in daily life.",2019,"Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine.","['outpatients receiving OAT', 'opioid-dependent participants (n\u202f=\u202f37) treated with']","['methadone', 'buprenorphine', 'opioid agonist treatment (OAT', 'cocaine']",[],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",[],,0.027314,"Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine.","[{'ForeName': 'Jeremiah W', 'Initials': 'JW', 'LastName': 'Bertz', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA. Electronic address: jeremiah.bertz@nih.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Epstein', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reamer', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kowalczyk', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Karran A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Kennedy', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Jobes', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ward', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Plitnick', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Rea', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Kenzie L', 'Initials': 'KL', 'LastName': 'Preston', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.011']
812,28289280,"Biochemical, physiological and clinical effects of l-methylfolate in schizophrenia: a randomized controlled trial.","Folic acid supplementation confers modest benefit in schizophrenia, but its effectiveness is influenced by common genetic variants in the folate pathway that hinder conversion to its active form. We examined physiological and clinical effects of l-methylfolate, the fully reduced and bioactive form of folate, in schizophrenia. In this randomized, double-blind trial, outpatients with schizophrenia (n=55) received l-methylfolate 15 mg or placebo for 12 weeks. Patients were maintained on stable doses of antipsychotic medications. The pre-defined primary outcome was change in plasma methylfolate at 12 weeks. Secondary outcomes included change in symptoms (Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms, Calgary Depression Scale for Schizophrenia), cognition (Measurement and Treatment Research to Improve Cognition in Schizophrenia composite) and three complementary magnetic resonance imaging measures (working memory-related activation, resting connectivity, cortical thickness). Primary, mixed model, intent-to-treat analyses covaried for six genetic variants in the folate pathway previously associated with symptom severity and/or response to folate supplementation. Analyses were repeated without covariates to evaluate dependence on genotype. Compared with placebo, l-methylfolate increased plasma methylfolate levels (d=1.00, P=0.0009) and improved PANSS Total (d=0.61, P=0.03) as well as PANSS Negative and General Psychopathology subscales. Although PANSS Total and General Psychopathology changes were influenced by genotype, significant PANSS Negative changes occurred regardless of genotype. No treatment differences were seen in other symptom rating scales or cognitive composite scores. Patients receiving l-methylfolate exhibited convergent changes in ventromedial prefrontal physiology, including increased task-induced deactivation, altered limbic connectivity and increased cortical thickness. In conclusion, l-methylfolate supplementation was associated with salutary physiological changes and selective symptomatic improvement in this study of schizophrenia patients, warranting larger clinical trials. ClinicalTrials.gov, NCT01091506.",2018,"Compared with placebo, l-methylfolate increased plasma methylfolate levels (d=1.00, P=0.0009) and improved PANSS Total (d=0.61, P=0.03) as well as PANSS Negative and General Psychopathology subscales.","['schizophrenia', 'outpatients with schizophrenia (n=55) received']","['l-methylfolate 15\u2009mg or placebo', 'l-methylfolate', 'Folic acid supplementation', 'placebo']","['plasma methylfolate', 'change in symptoms (Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms, Calgary Depression Scale for Schizophrenia), cognition (Measurement and Treatment Research to Improve Cognition in Schizophrenia composite) and three complementary magnetic resonance imaging measures (working memory-related activation, resting connectivity, cortical thickness', 'PANSS Negative and General Psychopathology subscales', 'symptom severity', 'task-induced deactivation, altered limbic connectivity and increased cortical thickness', 'PANSS Total and General Psychopathology changes', 'PANSS Total', 'ventromedial prefrontal physiology', 'plasma methylfolate levels', 'symptom rating scales or cognitive composite scores']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C2939773', 'cui_str': 'levomefolate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035168'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings (staging scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.262034,"Compared with placebo, l-methylfolate increased plasma methylfolate levels (d=1.00, P=0.0009) and improved PANSS Total (d=0.61, P=0.03) as well as PANSS Negative and General Psychopathology subscales.","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Roffman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Petruzzi', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Tanner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Ho', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giegold', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Silverstein', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bottiglieri', 'Affiliation': 'Center of Metabolomics, Institute of Metabolic Disease, Baylor Research Institute, Dallas, TX, USA.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Manoach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Smoller', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine and Nathan Kline Institute, New York, NY, USA.'}]",Molecular psychiatry,['10.1038/mp.2017.41']
813,28750059,High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.,"Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.",2017,Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date.,"['Mean age was 31.4 years (range 18-64 years', 'Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10', 'men who have sex with men (MSM) and transgender women']","['rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP', 'oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI']","['unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2929052', 'cui_str': 'emtricitabine / tenofovir disoproxil'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",187.0,0.0690638,Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Ivan C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America.'}, {'ForeName': 'Jeanna M', 'Initials': 'JM', 'LastName': 'Piper', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, United States of America.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Grossman', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'FHI 360, Durham, NC, United States of America.'}, {'ForeName': 'Kailazarid', 'Initials': 'K', 'LastName': 'Gomez', 'Affiliation': 'FHI 360, Durham, NC, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Horn', 'Affiliation': 'FHI 360, Durham, NC, United States of America.'}, {'ForeName': 'Ratiya Pamela', 'Initials': 'RP', 'LastName': 'Kunjara Na Ayudhya', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA, United States of America.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jacobson', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Chitwarakorn', 'Affiliation': 'Thailand Ministry of Public Health, Nonthaburi, Thailand.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Holtz', 'Affiliation': 'Thailand Ministry of Public Health-Centers for Disease Control Collaboration, Bangkok, Thailand.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Boston, MA, United States of America.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Zorrilla', 'Affiliation': 'Department of Medicine, University of Puerto Rico, San Juan, PR, United States of America.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McGowan', 'Affiliation': 'School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Cranston', 'Affiliation': 'School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of America.'}]",PloS one,['10.1371/journal.pone.0181607']
814,28957699,Randomized phase II trial of cytosine arabinoside with and without the CHK1 inhibitor MK-8776 in relapsed and refractory acute myeloid leukemia.,"PURPOSE


Cytosine arabinoside (AraC) remains the backbone of most treatment regimens for acute myeloid leukemia (AML). Incorporation of AraC into DNA activates checkpoint kinase 1 (Chk1), leading to cell-cycle arrest and diminished AraC cytotoxicity, which can be reversed by the selective Chk1 inhibitor MK-8776. Building on a Phase I trial, we conducted a phase II trial comparing timed sequential AraC with or without MK-8776.
METHODS


Patients with relapsed or primary refractory AML were randomized 1:1 to receive either AraC with MK-8776 (Arm A); or AraC alone (Arm B).
RESULTS


32 patients were treated: 14 assigned to Arm A and 18 to Arm B. There were 5 (36%) complete responses (CR/CRi) and 1 (7%) partial response (PR) in Arm A, and 8 (44%) CR/CRis and 1 (6%) PR in Arm B. Median survival did not differ significantly between the two groups (5.9months in Arm A vs. 4.5 months in Arm B). MK-8776 led to a robust increase in DNA damage in circulating leukemic blasts as measured by increased γ-H2AX (16.9%±6.1% prior and 36.4%±6.8% at one hour after MK-8776 infusion, p=0.016).
CONCLUSION


Response rates and survival were similar between the two groups in spite of evidence that MK-8776 augmented DNA damage in circulating leukemic blasts. Better than expected results in the control arm using timed sequential AraC and truncated patient enrollment may have limited the ability to detect clinical benefit from the combination.",2017,"CONCLUSION


Response rates and survival were similar between the two groups in spite of evidence that MK-8776 augmented DNA damage in circulating leukemic blasts.","['acute myeloid leukemia (AML', 'Patients with relapsed or primary refractory AML', '32 patients were treated: 14 assigned to Arm A and 18 to Arm B', 'relapsed and refractory acute myeloid leukemia']","['MK-8776', 'timed sequential AraC with or without MK-8776', 'AraC with MK-8776 (Arm A); or AraC alone (Arm B', 'cytosine arabinoside with and without the CHK1 inhibitor MK-8776', 'Cytosine arabinoside (AraC']","['CR/CRis and 1 (6%) PR in Arm B. Median survival', 'complete responses (CR/CRi', 'DNA damage in circulating leukemic blasts', 'partial response (PR', 'γ-H2AX']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2703183', 'cui_str': 'MK8776'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",32.0,0.0509793,"CONCLUSION


Response rates and survival were similar between the two groups in spite of evidence that MK-8776 augmented DNA damage in circulating leukemic blasts.","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Webster', 'Affiliation': 'Division of Hematologic Malignancies, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, United States. Electronic address: jwebst17@jhmi.edu.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Tibes', 'Affiliation': 'Department of Oncology, Mayo Clinic, Scottsdale, AZ, United States.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'The Blood & Marrow Transplant Group of Georgia, Atlanta, GA, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litzow', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Mrinal', 'Initials': 'M', 'LastName': 'Patnaik', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Rosner', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Gojo', 'Affiliation': 'Division of Hematologic Malignancies, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kinders', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'L Austin', 'Initials': 'LA', 'LastName': 'Doyle', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Huntoon', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Larry M', 'Initials': 'LM', 'LastName': 'Karnitz', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Karp', 'Affiliation': 'Division of Hematologic Malignancies, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, United States.'}, {'ForeName': 'B Douglas', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Division of Hematologic Malignancies, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, United States.'}]",Leukemia research,['10.1016/j.leukres.2017.09.005']
815,31204604,Family caregivers' perspectives on communication with cancer care providers.,"Purpose/Objectives:  Family caregivers of individuals living with cancer are often highly involved in communication with healthcare teams, yet little is known about their experiences, needs, and preferences in this role. To address this gap in the knowledge base, researchers sought to explore family caregivers' perspectives on communication with oncology care providers.  Design and Methods:  Researchers conducted a secondary inductive thematic analysis of qualitative interviews originally collected as part of a randomized clinical trial of a supportive intervention for family caregivers of patients with cancer ( N  = 63).  Participants:  Participants were family caregivers of adult patients with cancer. Most were patients' spouses/long-term partners (52.3%) or adult children/grandchildren (29.2%). Caregivers of patients with all cancer types and stages of disease progression were eligible for study enrollment.  Findings:  Caregivers valued communication with healthcare providers who were attentive, genuine, broadly focused on patients and caregivers' experiences, sensitive to unmet information needs, and responsive to the potentially different communication preferences of patients and caregivers.  Interpretation:  Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  Implications for Psychosocial Oncology Practice:  Psychosocial oncology providers' strong orientation to the biopsychosocial and spiritual aspects of cancer care delivery make them uniquely positioned to support family caregivers. Findings suggest that providers should explicitly communicate their commitment to both patient and family care, involve family caregivers in psychosocial assessment activities and subsequent intervention, and strive to honor patients and caregivers' potentially different communication preferences.",2019,"Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  ","['Family caregivers of individuals living with cancer', 'Participants were family caregivers of adult patients with cancer', 'Participants', 'Caregivers of patients with all cancer types and stages of disease progression were eligible for study enrollment', 'family caregivers of patients with cancer ( N \u2009=\u200963']",['supportive intervention'],[],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449385', 'cui_str': 'Staging of disease (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],,0.0250866,"Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  ","[{'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Craig', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Parker Oliver', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Ruggeri', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Brunk', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Goldstein', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'School of Nursing, University of Pennsylvania , Philadelphia , Pennsylvania , USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1624674']
816,28841387,Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.,"Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.",2017,Median overall survival had not been reached in either group ( P = .23).,"['Patients With Advanced Melanoma', 'patients with advanced melanoma', 'randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233', 'treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231', 'patients who discontinued treatment because of AEs']","['Nivolumab and Ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab 1 mg/kg plus ipilimumab', 'nivolumab combined with ipilimumab']","['Efficacy', 'objective response rate', 'median progression-free survival', 'efficacy and safety', 'Efficacy and Safety Outcomes', 'Median overall survival', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",409.0,0.161597,Median overall survival had not been reached in either group ( P = .23).,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Lao', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chesney', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Grossmann', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDermott', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Bhore', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Skłodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Université Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.73.2289']
817,30616442,Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss.,"Sedentary lifestyles and obesity are known risk factors for breast cancer. Elevated estrogen levels correlate with obesity and, independently, with increased breast cancer risk. Lifestyle interventions that reduce obesity may mitigate this risk, potentially via estrogen pathways. In a 6-month lifestyle intervention, overweight/obese women with high breast cancer risk were randomized to control ( n  = 7) or intervention ( n  = 6) and analyzed for sex hormone levels. Serum and urine hormones were evaluated by ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and sex hormone binding globulin (SHBG) by enzyme-linked immunosorbent assay (ELISA). Serum estrone (E1) and estradiol (E2) were reduced by 12.1% and 50.8%, respectively, at 9 months in the intervention group, which differed from controls ( p  = .043 and .020). This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p  = .035). These results suggest that a lifestyle intervention led to a favorable estrogen profile in relation to breast cancer risk.",2019,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"['Women With Elevated Breast Cancer Risk Undergoing Weight Loss', 'overweight/obese women with high breast cancer risk']",[],"['Serum and urine hormones', 'Serum estrone (E1) and estradiol (E2', 'urine E1']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]",,0.015685,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"[{'ForeName': 'Sophia A', 'Initials': 'SA', 'LastName': 'Stone', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Claire J', 'Initials': 'CJ', 'LastName': 'Han', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Taurence', 'Initials': 'T', 'LastName': 'Senn', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Dynamic Paths, Inc., Tacoma, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reding', 'Affiliation': 'Integrative Counseling Services, Seattle, WA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Whittington', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",Western journal of nursing research,['10.1177/0193945918820672']
818,28282996,Enhancing outcomes for persons with co-occurring disorders through skills training and peer recovery support.,"Background : ""Recovery supports"", often provided by persons in recovery themselves, have emerged over the last decade as important components of recovery-oriented systems of care for persons with substance use disorders. Aims : This study assesses the benefit of adding peer recovery supports to the care of adults with co-occurring psychosis and substance use. Method : 137 adults with both disorders who had at least one prior admission within the past year were recruited during an index hospitalization into a randomized trial of standard care vs skills training with and without a peer-led social engagement program. Participants were assessed at admission and at three and nine months post-discharge on symptoms, functioning, substance use, and other factors. Results : At three months, skills training was effective in reducing alcohol use and symptoms, with the addition of peer-led support resulting in higher levels of relatedness, self-criticism, and outpatient service use. At nine months, skills training was effective in decreasing symptoms and inpatient readmissions and increasing functioning, with the addition of peer support resulting in reduced alcohol use. Conclusions : Adding peer-led support may increase engagement in care over the short term and reduce substance use over the longer-term for adults with co-occurring disorders.",2020,Adding peer-led support may increase engagement in care over the short term and reduce substance use over the longer-term for adults with co-occurring disorders.,"['137 adults with both disorders who had at least one prior admission within the past year were recruited during an index hospitalization into a randomized trial of', 'adults with co-occurring psychosis and substance use', 'adults with co-occurring disorders', 'persons with substance use disorders', 'persons with co-occurring disorders through skills training and peer recovery support']","['skills training', 'standard care vs skills training with and without a peer-led social engagement program']",[],"[{'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],137.0,0.1005,Adding peer-led support may increase engagement in care over the short term and reduce substance use over the longer-term for adults with co-occurring disorders.,"[{'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA and.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA and.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Delphin-Rittmon', 'Affiliation': 'Connecticut Department of Mental Health and Addiction Services, Hartford, CT, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA and.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2017.1294733']
819,31368192,High-dose ethanol intoxication decreases 1/f neural noise or scale-free neural activity in the resting state.,"Binge drinking is a frequent phenomenon in many western societies and has been associated with an increased risk of developing alcohol use disorder later in life. Yet, the effects of high-dose alcohol intoxication on neurophysiological processes are still quite poorly understood. This is particularly the case given that neurophysiological brain activity not only contains recurring (oscillatory) patterns of activity, but also a significant fraction of ""scale-free"" or arrhythmic dynamics referred to as 1/f type activity, pink noise, or 1/f neural noise. Neurobiological considerations suggest that it should be modulated by alcohol intoxication. To investigate this assumption, we collected resting state EEG data from n = 23 healthy young male subjects in a crossover design, where each subject was once tested sober and once tested while intoxicated (mean breath alcohol concentration of 1.1 permille ±0.2). Analyses of the 1/f neural dynamics showed that ethanol intoxication decreased resting state 1/f neural noise, as compared with a sober state. The effects were strongest when the eyes were closed and particularly reliable in the beta frequency band. Given that the dynamics of the beta band have been shown to strongly depend on GABA A  receptor neural transmission, this finding nicely aligns with the fact that ethanol increases GABAergic signaling. The study reveals a currently unreported effect of binge drinking on neurophysiological dynamics, which likely revealed a higher sensitivity for ethanol effects than most commonly considered measures of power in neural oscillations. Implications and applicability of these findings are discussed.",2020,"Analyses of the 1/f neural dynamics showed that ethanol intoxication decreased resting state 1/f neural noise, as compared with a sober state.",['n = 23 healthy young male subjects'],['High-dose ethanol intoxication'],"['ethanol intoxication decreased resting state 1/f neural noise', 'neural noise or scale-free neural activity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]","[{'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0222045'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",23.0,0.0195547,"Analyses of the 1/f neural dynamics showed that ethanol intoxication decreased resting state 1/f neural noise, as compared with a sober state.","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU, Dresden, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Pertermann', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU, Dresden, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mückschel', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU, Dresden, Germany.'}]",Addiction biology,['10.1111/adb.12818']
820,28407660,"The Effects of Calcium, Vitamins D and K co-Supplementation on Markers of Insulin Metabolism and Lipid Profiles in Vitamin D-Deficient Women with Polycystic Ovary Syndrome.","Data on the effects of calcium, vitamins D and K co-supplementation on markers of insulin metabolism and lipid profiles among vitamin D-deficient women with polycystic ovary syndrome (PCOS) are scarce. This study was done to determine the effects of calcium, vitamins D and K co-supplementation on markers of insulin metabolism and lipid profiles in vitamin D-deficient women with PCOS. This randomized double-blind, placebo-controlled trial was conducted among 55 vitamin D-deficient women diagnosed with PCOS aged 18-40 years old. Subjects were randomly assigned into 2 groups to intake either 500 mg calcium, 200 IU vitamin D and 90 µg vitamin K supplements (n=28) or placebo (n=27) twice a day for 8 weeks. After the 8-week intervention, compared with the placebo, joint calcium, vitamins D and K supplementation resulted in significant decreases in serum insulin concentrations (-1.9±3.5 vs. +1.8±6.6 µIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (-0.4±0.7 vs. +0.4±1.4, P=0.01), homeostasis model of assessment-estimated b cell function (-7.9±14.7 vs. +7.0±30.3, P=0.02) and a significant increase in quantitative insulin sensitivity check index (+0.01±0.01 vs. -0.008±0.03, P=0.01). In addition, significant decreases in serum triglycerides (-23.4±71.3 vs. +9.9±39.5 mg/dL, P=0.03) and VLDL-cholesterol levels (-4.7±14.3 vs. +2.0±7.9 mg/dL, P=0.03) was observed following supplementation with combined calcium, vitamins D and K compared with the placebo. Overall, calcium, vitamins D and K co-supplementation for 8 weeks among vitamin D-deficient women with PCOS had beneficial effects on markers of insulin metabolism, serum triglycerides and VLDL-cholesterol levels.",2017,"In addition, significant decreases in serum triglycerides (-23.4±71.3 vs. +9.9±39.5 mg/dL, P=0.03) and VLDL-cholesterol levels (-4.7±14.3 vs. +2.0±7.9 mg/dL, P=0.03) was observed following supplementation with combined calcium, vitamins D and K compared with the placebo.","['Vitamin D-Deficient Women with Polycystic Ovary Syndrome', 'vitamin D-deficient women with polycystic ovary syndrome (PCOS', '55 vitamin D-deficient women diagnosed with PCOS aged 18-40 years old', 'vitamin D-deficient women with PCOS']","['placebo, joint calcium, vitamins D and K supplementation', 'calcium, 200 IU vitamin D and 90\u2009µg vitamin K supplements', 'Calcium, Vitamins D and K co-Supplementation', 'placebo', 'calcium, vitamins D and K co-supplementation']","['serum insulin concentrations', 'insulin metabolism, serum triglycerides and VLDL-cholesterol levels', 'Insulin Metabolism and Lipid Profiles', 'quantitative insulin sensitivity check index', 'insulin metabolism and lipid profiles', 'homeostasis model of assessment-estimated insulin resistance', 'Overall, calcium, vitamins D and K co-supplementation', 'serum triglycerides', 'VLDL-cholesterol levels', 'homeostasis model of assessment-estimated b cell function']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3661606', 'cui_str': 'Vitamin K supplement'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.639475,"In addition, significant decreases in serum triglycerides (-23.4±71.3 vs. +9.9±39.5 mg/dL, P=0.03) and VLDL-cholesterol levels (-4.7±14.3 vs. +2.0±7.9 mg/dL, P=0.03) was observed following supplementation with combined calcium, vitamins D and K compared with the placebo.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ashrafi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryamalsadat', 'Initials': 'M', 'LastName': 'Razavi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Akbari', 'Affiliation': 'Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/s-0043-104530']
821,29864379,Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations.,"Purpose ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-naïve patients with advanced non-small-cell lung cancer (NSCLC) and activating mutations in EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is presented here. Patients and Methods In this multinational, multicenter study, patients age 18 years or older (≥ 20 years in Japan and Korea) who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and newly diagnosed NSCLC with activating mutations in EGFR (exon 19 deletion or exon 21 L858R) were enrolled and randomly assigned in a 1:1 manner to dacomitinib (n = 227) or gefitinib (n = 225). Random assignment was stratified by race (Japanese, Chinese, other East Asian, or non-Asian) and EGFR mutation type. The final OS analysis was conducted with a data cutoff date of February 17, 2017; at that time 220 deaths (48.7%) were observed. Results During a median follow-up time of 31.3 months, 103 (45.4%) and 117 (52.0%) deaths occurred in the dacomitinib and gefitinib arms, respectively. The estimated hazard ratio for OS was 0.760 (95% CI, 0.582 to 0.993; two-sided P = .044). The median OS was 34.1 months with dacomitinib versus 26.8 months with gefitinib. The OS probabilities at 30 months were 56.2% and 46.3% with dacomitinib and gefitinib, respectively. Preliminary subgroup analyses for OS that are based on baseline characteristics were consistent with the primary OS analysis. Conclusion In patients with advanced NSCLC and EGFR activating mutations, dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) to show significant improvement in OS in a phase III randomized study compared with a standard-of-care TKI. Dacomitinib should be considered one of the standard treatment options for these patients.",2018,The estimated hazard ratio for OS was 0.760,"['patients age 18 years or older (≥ 20 years in Japan and Korea) who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and newly diagnosed NSCLC with activating mutations in EGFR (exon 19 deletion or exon 21 L858R', 'patients with advanced NSCLC and EGFR activating mutations', 'Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations', 'treatment-naïve patients with advanced non-small-cell lung cancer (NSCLC']","['dacomitinib', 'dacomitinib versus gefitinib', 'gefitinib', 'Dacomitinib With Gefitinib']","['estimated hazard ratio for OS', 'OS probabilities', 'Overall Survival', 'median OS', 'mature overall survival (OS) analysis', 'deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2987430'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.176283,The estimated hazard ratio for OS was 0.760,"[{'ForeName': 'Tony S', 'Initials': 'TS', 'LastName': 'Mok', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Linke', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Migliorino', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Eric I', 'Initials': 'EI', 'LastName': 'Sbar', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Jane Liang', 'Initials': 'JL', 'LastName': 'White', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Tony S. Mok, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun; Xiangdong Zhou, First Affiliated Hospital of Third Military Medical University, Chongqing; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; Ki Hyeong Lee, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea; Kazuhiko Nakagawa, Kindai University Hospital, Osaka; Seiji Niho, National Cancer Center Hospital East, Kashiwa, Japan; Min Lee, SFJ Asia Pacific, Singapore; Rolf Linke, SFJ Pharmaceuticals Group, Pleasanton, CA; Rafael Rosell, Catalan Institute of Oncology, Barcelona; Jesus Corral, Hospital Universitario Virgen del Rocio, Seville, Spain; Maria Rita Migliorino, Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy; Adam Pluzanski, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Eric I. Sbar, Pfizer, Collegeville, PA; Tao Wang and Jane Liang White, Pfizer, Groton, CT.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.7994']
822,30084949,A maximum likelihood approach to power calculations for stepped wedge designs of binary outcomes.,"In stepped wedge designs (SWD), clusters are randomized to the time period during which new patients will receive the intervention under study in a sequential rollout over time. By the study's end, patients at all clusters receive the intervention, eliminating ethical concerns related to withholding potentially efficacious treatments. This is a practical option in many large-scale public health implementation settings. Little statistical theory for these designs exists for binary outcomes. To address this, we utilized a maximum likelihood approach and developed numerical methods to determine the asymptotic power of the SWD for binary outcomes. We studied how the power of a SWD for detecting risk differences varies as a function of the number of clusters, cluster size, the baseline risk, the intervention effect, the intra-cluster correlation coefficient, and the time effect. We studied the robustness of power to the assumed form of the distribution of the cluster random effects, as well as how power is affected by variable cluster size. % SWD power is sensitive to neither, in contrast to the parallel cluster randomized design which is highly sensitive to variable cluster size. We also found that the approximate weighted least square approach of Hussey and Hughes (2007, Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others. The new method was applied to the design of a large-scale intervention program on post-partum intra-uterine device insertion services for preventing unintended pregnancy in the first 1.5 years following childbirth in Tanzania, where it was found that the previously available method under-estimated the power.",2020,"Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others.",[],[],[],[],[],[],,0.0305755,"Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA and AbbVie Inc., 1400 Sheridan Rd, North Chicago, IL, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Kunz', 'Affiliation': 'Deloitte, 30 Rockefeller Plaza, New York, NY, USA.'}, {'ForeName': 'Sharon-Lise T', 'Initials': 'ST', 'LastName': 'Normand', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxy031']
823,31684694,Interventions to reduce Staphylococcus aureus in the management of eczema.,"BACKGROUND


Staphylococcus aureus (S. aureus) can cause secondary infection in eczema, and may promote inflammation in eczema that does not look infected. There is no standard intervention to reduce S. aureus burden in eczema. It is unclear whether antimicrobial treatments help eczema or promote bacterial resistance. This is an update of a 2008 Cochrane Review.
OBJECTIVES


To assess the effects of interventions to reduce S. aureus for treating eczema.
SEARCH METHODS


We updated our searches of the following databases to October 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We searched five trials registers and three sets of conference proceedings. We checked references of trials and reviews for further relevant studies. We contacted pharmaceutical companies regarding ongoing and unpublished trials.
SELECTION CRITERIA


Randomised controlled trials of products intended to reduce S. aureus on the skin in people diagnosed with atopic eczema by a medical practitioner. Eligible comparators were a similar treatment regimen without the anti-staphylococcal agent.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. Our key outcomes were participant- or assessor-rated global improvement in symptoms/signs, quality of life (QOL), severe adverse events requiring withdrawal, minor adverse events, and emergence of antibiotic-resistant micro-organisms.
MAIN RESULTS


We included 41 studies (1753 analysed participants) covering 10 treatment categories. Studies were conducted mainly in secondary care in Western Europe; North America; the Far East; and elsewhere. Twelve studies recruited children; four, adults; 19, both; and six, unclear. Fifty-nine per cent of the studies reported the mean age of participants (range: 1.1 to 34.6 years). Eczema severity ranged from mild to severe. Many studies did not report our primary outcomes. Treatment durations ranged from 10 minutes to 3 months; total study durations ranged from 15 weeks to 27 months. We considered 33 studies at high risk of bias in at least one domain. We present results for three key comparisons. All time point measurements were taken from baseline. We classed outcomes as short-term when treatment duration was less than four weeks, and long-term when treatment was given for more than four weeks. Fourteen studies evaluated topical steroid/antibiotic combinations compared to topical steroids alone (infective status: infected (two studies), not infected (four studies), unspecified (eight studies)). Topical steroid/antibiotic combinations may lead to slightly greater global improvement in good or excellent signs/symptoms than topical steroid alone at 6 to 28 days follow-up (risk ratio (RR) 1.10, 95% confidence interval (CI) 1.00 to 1.21; 224 participants; 3 studies, low-quality evidence). There is probably little or no difference between groups for QOL in children, at 14 days follow-up (mean difference (MD) -0.18, 95% CI -0.40 to 0.04; 42 participants; 1 study, moderate-quality evidence). The subsequent results for this comparison were based on very low-quality evidence, meaning we are uncertain of their validity: severe adverse events were rare (follow-up: between 6 to 28 days): both groups reported flare of dermatitis, worsening of the condition, and folliculitis (325 participants; 4 studies). There were fewer minor adverse events (e.g. flare, stinging, itch, folliculitis) in the combination group at 14 days follow-up (218 participants; 2 studies). One study reported antibiotic resistance in children at three months follow-up, with similar results between the groups (65 participants; 1 study). Four studies evaluated oral antibiotics compared to placebo (infective status: infected eczema (two studies), uninfected (one study), one study's participants had colonisation but no clinical infection). Oral antibiotics may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo (RR 0.80; 95% CI 0.18 to 3.50; 75 participants; 2 studies, low-quality evidence). There is probably little or no difference between groups for QOL (in infants and children) at 14 days follow-up (MD 0.11, 95% CI -0.10 to 0.32, 45 participants, 1 study, moderate-quality evidence). The subsequent results for this comparison were based on very low-quality evidence, meaning we are uncertain of their validity: adverse events requiring treatment withdrawal between 14 to 28 days follow-up were very rare, but included eczema worsening (both groups), loose stools (antibiotic group), and Henoch-Schönlein purpura (placebo group) (4 studies, 199 participants). Minor adverse events, including nausea, vomiting, diarrhoea, and stomach and joint pains, at 28 days follow-up were also rare and generally low in both groups (1 study, 68 infants and children). Antibiotic resistance at 14 days was reported as similar in both groups (2 studies, 98 infants and children). Of five studies evaluating bleach baths compared to placebo (water) or bath emollient (infective status: uninfected (two studies), unspecified (three studies)), one reported global improvement and showed that bleach baths may make no difference when compared with placebo at one month follow-up (RR 0.78, 95% CI 0.37 to 1.63; 36 participants; low-quality evidence). One study showed there is probably little or no difference in QOL at 28 days follow-up when comparing bleach baths to placebo (MD 0.90, 95% CI -1.32 to 3.12) (80 infants and children; moderate-quality evidence). We are uncertain if the groups differ in the likelihood of treatment withdrawals due to adverse events at two months follow-up (only one dropout reported due to worsening itch (placebo group)) as the quality of evidence was very low (1 study, 42 participants). One study reported that five participants in each group experienced burning/stinging or dry skin at two months follow-up, so there may be no difference in minor adverse events between groups (RR 1.00, 95% CI 0.35 to 2.87, 36 participants, low-quality evidence). Very low-quality evidence means we are also uncertain if antibiotic resistance at four weeks follow-up is different between groups (1 study, 80 participants ≤ 18 years).
AUTHORS' CONCLUSIONS


We found insufficient evidence on the effects of anti-staphylococcal treatments for treating people with infected or uninfected eczema. Low-quality evidence, due to risk of bias, imprecise effect estimates and heterogeneity, made pooling of results difficult. Topical steroid/antibiotic combinations may be associated with possible small improvements in good or excellent signs/symptoms compared with topical steroid alone. High-quality trials evaluating efficacy, QOL, and antibiotic resistance are required.",2019,"Oral antibiotics may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo (RR 0.80; 95% CI 0.18 to 3.50; 75 participants; 2 studies, low-quality evidence).","['treating people with infected or uninfected eczema', 'people diagnosed with atopic eczema by a medical practitioner', ""infective status: infected eczema (two studies), uninfected (one study), one study's participants had colonisation but no clinical infection"", '98 infants and children', 'Twelve studies recruited children; four, adults; 19, both; and six, unclear', '41 studies (1753 analysed participants) covering 10 treatment categories', '80 participants ≤ 18 years']","['topical steroid/antibiotic combinations', 'placebo', 'anti-staphylococcal treatments', 'Topical steroid/antibiotic combinations', 'topical steroids']","['minor adverse events', 'antibiotic resistance', 'nausea, vomiting, diarrhoea, and stomach and joint pains', 'adverse events (e.g. flare, stinging, itch, folliculitis', 'Antibiotic resistance', 'efficacy, QOL, and antibiotic resistance', 'symptoms/signs, quality of life (QOL), severe adverse events requiring withdrawal, minor adverse events, and emergence of antibiotic-resistant micro-organisms', 'QOL', 'burning/stinging or dry skin']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1322253', 'cui_str': 'Infected eczema (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection (disorder)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0016436', 'cui_str': 'Folliculitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0151908', 'cui_str': 'Dry skin (finding)'}]",199.0,0.350988,"Oral antibiotics may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo (RR 0.80; 95% CI 0.18 to 3.50; 75 participants; 2 studies, low-quality evidence).","[{'ForeName': 'Susannah Mc', 'Initials': 'SM', 'LastName': 'George', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton General Hospital, Department of Dermatology, Brighton General Hospital, Elm Grove, Brighton, UK, BN2 3EW.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Karanovic', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Department of Dermatology, Mindelsohn Way, Birmingham, UK, B15 2TH.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit & Research Centre, Napier House, 24 High Holborn, London, UK, WC1V 6AZ.'}, {'ForeName': 'Anjna', 'Initials': 'A', 'LastName': 'Rani', 'Affiliation': ""Centre of Evidence Based Dermatology, (c/o) Cochrane Skin Group, The University of Nottingham, Room A103, King's Meadow Campus, Lenton Lane, Nottingham, UK, NG7 2NR.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Birnie', 'Affiliation': 'East Kent Hospitals University Foundation NHS Trust, Department of Dermatology, Kent & Canterbury Hospital, Ethelbert Road, Canterbury, UK, CT1 3NG.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Bath-Hextall', 'Affiliation': 'University of Nottingham, School of Health Sciences, B Floor, South Block Link, Queens Medical Centre, Nottingham, UK, NG7 2HA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Ravenscroft', 'Affiliation': ""Nottingham University Hospitals NHS Trust, Dermatology, Derby Road, Queen's Medical Centre Campus, Nottingham, UK, NG7 2UH.""}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': ""University of Nottingham, Centre of Evidence Based Dermatology, Queen's Medical Centre, Derby Road, Nottingham, UK, NG7 2UH.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003871.pub3']
824,31898309,Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.,"BACKGROUND


Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored.
METHODS


Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time.
RESULTS


Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning.
CONCLUSIONS


Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03149185.",2020,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","['men with APC', 'Men with APC (N\u2009=\u2009192', 'Men with advanced prostate cancer (APC', 'Men with Advanced Prostate Cancer']","['CBSM', 'cognitive-behavioral stress management (CBSM', 'CBSM or HP', 'tablet-delivered, group-based psychosocial intervention', 'Technology-Based Psychosocial Intervention']","['HRQOL and symptom burden', 'baseline interpersonal disruption, fatigue, and sexual functioning', 'Quality of Life', 'cancer-related anxiety, cancer-related distress, and feelings of cohesiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.300426,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","[{'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. frank.penedo@miami.edu.'}, {'ForeName': 'Rina S', 'Initials': 'RS', 'LastName': 'Fox', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Oswald', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cody L', 'Initials': 'CL', 'LastName': 'Boland', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA.'}, {'ForeName': 'Ryne', 'Initials': 'R', 'LastName': 'Estabrook', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McGinty', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Begale', 'Affiliation': 'Vibrent Health, Fairfax, VA, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Dahn', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Miami Veterans Affairs Healthcare System, Miami, FL, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Flury', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kent T', 'Initials': 'KT', 'LastName': 'Perry', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Shilajit D', 'Initials': 'SD', 'LastName': 'Kundu', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09839-7']
825,31573893,Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients.,"BACKGROUND


Chronic Hepatitis C (CHC) is a common progressive healthcare challenge that leads to liver cirrhosis, liver failure, and hepatocellular carcinoma. The optimum therapy was a combination of pegylated interferon and ribavirin, which was associated with moderate response and severe side effects. Sofosbuvir revolutionized CHC treatment, especially in combination with other antiviral agents.
OBJECTIVE


The aim of this study was to compare and evaluate the safety and efficacy of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve patients with chronic Hepatitis C Virus (HCV) genotype 4 infection for 12 weeks.
METHODS


One hundred CHC genotype 4 patients (70 females, 30 males) were recruited from the hepatology clinic at the Beni-Suef general hospital. Patients were randomly allocated into two groups that received a 12 weeks treatment of either sofosbuvir 400 mg/daclatasvir 60 mg or sofosbuvir 400 mg/ledipasvir 90 mg. The sustained virological response 12 weeks post-treatment (SVR12) (HCV RNA < Lower Limit of Quantification (LLOQ)) was determined to evaluate efficacy. The clinical laboratory tests and any reported adverse effects starting from the administration of the first dose till 30 days after the last dose were assessed to evaluate safety. The main outcome measure was the assessment of the safety, efficacy and compliance of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve CHC genotype 4 patients for 12 weeks.
RESULTS


SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir and sofosbuvir plus daclatasvir, respectively. The most common adverse events reported were headache, and fatigue. No patients discontinued treatment due to adverse events.
CONCLUSION


The findings from this study suggest that the 12 weeks treatment regimens of sofosbuvir plus daclatasvir and sofosbuvir plus ledipasvir were both efficacious and well-tolerated in patients with HCV genotype 4 infection. Impact on Practice: In this paper, we report on the most recent approaches in the treatment of Hepatitis C genotype 4 patients in Egypt. This is significant because this article focuses on comparing the efficacy and tolerability of the most commonly used antiviral drugs in Egypt.",2020,"RESULTS


SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir and sofosbuvir plus daclatasvir, respectively.","['Chronic Hepatitis C Genotype 4 Patients', 'Egyptian patients with HCV genotype 4 infection', 'non-cirrhotic naïve patients for 12 weeks in CHC patients', 'One hundred patients (70 females, 30 males) were recruited from Hepatology clinic at Beni-Suef general hospital', 'The current study was conducted in Hepatology clinic at Beni-Suef general hospital']","['Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir', 'pegylated interferon and ribavirin', 'sofosbuvir/daclatasvir versus sofosbuvir/ledipasvir', 'sofosbuvir 400 mg/daclatasvir 60 mg or sofosbuvir 400 mg/ledipasvir 90 mg']","['headache, and fatigue', 'moderate response and severe side effects', 'adverse effects', 'safety, efficacy and compliance of sofosbuvir/daclatasvir versus sofosbuvir/ledipasvir', 'sustained virological response 12 weeks post treatment (SVR12) (HCV RNA < Lower Limit of Quantification (LLOQ', 'safety and efficacy']","[{'cui': 'C4049431', 'cui_str': 'Chronic hepatitis C genotype 4'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086403', 'cui_str': 'Hepatology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C3858051', 'cui_str': 'ledipasvir / sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C3851350', 'cui_str': 'ledipasvir'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}, {'cui': 'C4046943', 'cui_str': 'daclatasvir 60 MG [Daklinza]'}, {'cui': 'C3858262', 'cui_str': 'ledipasvir 90 MG'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C3851350', 'cui_str': 'ledipasvir'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",100.0,0.0319795,"RESULTS


SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir and sofosbuvir plus daclatasvir, respectively.","[{'ForeName': 'Lamiaa N', 'Initials': 'LN', 'LastName': 'Abdelaty', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Elnaggar', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amira A', 'Initials': 'AA', 'LastName': 'Said', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Raghda R S', 'Initials': 'RRS', 'LastName': 'Hussein', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",Current drug safety,['10.2174/1574886314666191001151314']
826,28122931,Long-Term Vitamin D Supplementation Affects Metabolic Status in Vitamin D-Deficient Type 2 Diabetic Patients with Coronary Artery Disease.,"Background:  Vitamin D might be beneficial in diabetic patients with coronary artery disease (CAD) through its favorable effects on metabolic profiles and biomarkers of inflammation and oxidative stress. Objective:  This study was performed to examine the effects of 6 mo of vitamin D supplementation on metabolic status in diabetic patients with CAD. Methods:  This randomized, double-blind, placebo-controlled clinical trial was conducted in 60 vitamin D-deficient diabetic patients with CAD aged 40-85 y. Subjects were randomly assigned into 2 groups to take either 50,000-IU vitamin D supplements ( n  = 30) or placebo ( n  = 30) every 2 wk for 6 mo. Fasting blood samples were obtained at the beginning of the study and after the 6-mo intervention to quantify glycemic indicators, lipid concentrations, and biomarkers of inflammation and oxidative stress. Results:  Compared with placebo, vitamin D supplementation resulted in significant reductions in fasting plasma glucose (-14.9 ± 7.1 compared with +19.3 ± 7.1 mg/dL;  P  = 0.001), serum insulin (-2.7 ± 1.1 compared with +1.8 ± 1.1 μIU/mL;  P  = 0.006), homeostasis model assessment of insulin resistance (-0.7 ± 0.3 compared with +0.5 ± 0.3;  P  = 0.01), and β cell function (-9.1 ± 4.2 compared with +5.7 ± 4.2;  P  = 0.01) and a significant increase in serum vitamin D (+6.8 ± 0.9 compared with +0.1 ± 0.9 ng/mL;  P  < 0.001) and the Quantitative Insulin Sensitivity Check Index (+0.008 ± 0.004 compared with -0.007 ± 0.004;  P  = 0.01). In addition, changes in serum high-sensitivity C-reactive protein (hs-CRP; -1.0 ± 0.5 compared with +0.6 ± 0.5 μg/mL;  P  = 0.02), plasma nitric oxide (NO; +7.0 ± 2.0 compared with -4.6 ± 2.0 μmol/L;  P  < 0.001), total reduced glutathione (GSH; +104 ± 16.4 compared with +24.8 ± 16.4 μmol/L;  P  = 0.001), and malondialdehyde concentrations (-0.2 ± 0.1 compared with +0.2 ± 0.1 μmol/L;  P  < 0.001) in the supplemented group were significantly different from the changes in these indicators in the placebo group. Conclusions:  Overall, 6 mo of vitamin D supplementation among vitamin D-deficient diabetic patients with CAD had beneficial effects on glycemic control and serum hs-CRP, NO, GSH, and malondialdehyde concentrations. This trial was registered on the Iranian website (www.irct.ir) for registration of clinical trials as IRCT201510315623N56.",2017,", vitamin D supplementation resulted in significant reductions in fasting plasma glucose (-14.9 ± 7.1 compared with +19.3 ± 7.1 mg/dL;  P  = 0.001), serum insulin (-2.7 ± 1.1 compared with +1.8 ± 1.1 μIU/mL;  P  = 0.006), homeostasis model assessment of insulin resistance (-0.7 ± 0.3 compared with +0.5 ± 0.3;  P  = 0.01), and β cell function (-9.1 ± 4.2 compared with +5.7 ± 4.2;  P  = 0.01) and a significant increase in serum vitamin D (+6.8 ± 0.9 compared with +0.1 ± 0.9 ng/mL;  P  < 0.001) and the Quantitative Insulin Sensitivity Check Index (+0.008 ± 0.004 compared with -0.007 ± 0.004;  P  = 0.01).","['Vitamin D-Deficient Type 2 Diabetic Patients with Coronary Artery Disease', 'diabetic patients with coronary artery disease (CAD', 'vitamin D-deficient diabetic patients with CAD', '40-85 y. Subjects', 'diabetic patients with CAD', '60 vitamin D-deficient diabetic patients with CAD aged']","['vitamin D supplementation', 'placebo', 'Vitamin D', 'Vitamin D Supplementation', '50,000-IU vitamin D supplements']","['Quantitative Insulin Sensitivity Check Index', 'plasma nitric oxide', 'malondialdehyde concentrations', 'glycemic indicators, lipid concentrations, and biomarkers of inflammation and oxidative stress', 'glycemic control and serum hs-CRP, NO, GSH, and malondialdehyde concentrations', 'β cell function', 'metabolic status', 'homeostasis model assessment of insulin resistance', 'total reduced glutathione', 'Fasting blood samples', 'Metabolic Status', 'serum insulin', 'serum high-sensitivity C-reactive protein', 'serum vitamin D', 'fasting plasma glucose']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.431729,", vitamin D supplementation resulted in significant reductions in fasting plasma glucose (-14.9 ± 7.1 compared with +19.3 ± 7.1 mg/dL;  P  = 0.001), serum insulin (-2.7 ± 1.1 compared with +1.8 ± 1.1 μIU/mL;  P  = 0.006), homeostasis model assessment of insulin resistance (-0.7 ± 0.3 compared with +0.5 ± 0.3;  P  = 0.01), and β cell function (-9.1 ± 4.2 compared with +5.7 ± 4.2;  P  = 0.01) and a significant increase in serum vitamin D (+6.8 ± 0.9 compared with +0.1 ± 0.9 ng/mL;  P  < 0.001) and the Quantitative Insulin Sensitivity Check Index (+0.008 ± 0.004 compared with -0.007 ± 0.004;  P  = 0.01).","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farrokhian', 'Affiliation': 'Department of Cardiology, School of Medicine.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Raygan', 'Affiliation': 'Department of Cardiology, School of Medicine.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, and.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Talari', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Esfandiari', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, and asemi_r@yahoo.com.'}]",The Journal of nutrition,['10.3945/jn.116.242008']
827,32059704,Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC) - a phase III study of the German registry of incidental gallbladder carcinoma platform (GR)- the AIO/ CALGP/ ACO- GAIN-trial.,"BACKGROUND


Currently, complete surgical resection represents the only potentially curative treatment option for Biliary Tract Cancer (BTC) including Gallbladder Cancer (GBC). Even after curative resection, 5-year OS is only 20-40%. Gallbladder carcinoma is relatively rare, but still the fifth most common neoplasm of the digestive tract and even the most frequent cancer of the biliary system. Gallbladder carcinoma is suspected preoperatively in only 30% of all pts., while the majority of cases are discovered incidentally by the pathologist after cholecystectomy for a benign indication. For improving curative rates in BTC and GBC, early systemic therapy combined with radical resection seems to be a promising approach. The earliest moment to apply chemotherapy would be in front of radical surgery. The encouraging results of neoadjuvant/perioperative concepts in other malignancies provide an additional rationale to use this treatment in the early phase of GBC management and even ICC/ECC. Especially because data regarding pure adjuvant chemotherapy in BTC's are conflicting.
METHODS


This is a multicenter, randomized, controlled, open-label phase III study including pts. with incidentally discovered GBCs after simple cholecystectomy in front of radical liver resection and pts. with resectable/ borderline resectable cholangiocarcinomas (ICC/ ECC) scheduled to receive perioperative chemotherapy (Gemcitabine + Cisplatin 3 cycles pre- and post-surgery) or surgery alone followed by a therapy of investigator's choice. Primary endpoint is OS; secondary endpoints are PFS, R0-resection rate, toxicity, perioperative morbidity, mortality and QoL. A total of N = 333 patients with GBC or BTC will be included. Recruitment has started in August 2019.
DISCUSSION


The current proposed phase III GAIN study investigates whether induction chemotherapy followed by radical resection in ICC/ECC and re-resection in IGBC (and - if possible - postoperative chemotherapy) prolongs overall survival compared to radical surgery alone for incidental gallbladder carcinoma and primary resectable or borderline resectable cholangiocarcinoma. Utilizing a neoadjuvant approach including a second radical surgery will help to raise awareness for the necessity of radical surgery, especially second radical completion surgery in IGBC and improve the adherence to the guidelines.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03673072 from 17.09.2018. EudraCT number: 2017-004444-38 from 02.11.2017.",2020,"Utilizing a neoadjuvant approach including a second radical surgery will help to raise awareness for the necessity of radical surgery, especially second radical completion surgery in IGBC and improve the adherence to the guidelines.
","['Biliary Tract Cancer (BTC) including Gallbladder Cancer (GBC', 'incidental gallbladder carcinoma and primary resectable or borderline resectable cholangiocarcinoma', 'incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC) - a phase III study of the German registry of incidental gallbladder carcinoma platform (GR)- the AIO/ CALGP', 'with resectable/ borderline resectable cholangiocarcinomas (ICC/ ECC) scheduled to receive']","['radical resection', 'radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy', 'induction chemotherapy followed by radical resection in ICC/ECC and re-resection in IGBC (and - if possible - postoperative chemotherapy', 'perioperative chemotherapy (Gemcitabine + Cisplatin 3\u2009cycles pre- and post-surgery) or surgery alone', 'radical surgery alone', 'Neoadjuvant chemotherapy with gemcitabine plus cisplatin']","['overall survival', '5-year OS', 'OS; secondary endpoints are PFS, R0-resection rate, toxicity, perioperative morbidity, mortality and QoL. A total of N\u2009=\u2009333 patients with GBC or BTC', 'Gallbladder carcinoma']","[{'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder (disorder)'}]",333.0,0.0680849,"Utilizing a neoadjuvant approach including a second radical surgery will help to raise awareness for the necessity of radical surgery, especially second radical completion surgery in IGBC and improve the adherence to the guidelines.
","[{'ForeName': 'Thorsten O', 'Initials': 'TO', 'LastName': 'Goetze', 'Affiliation': 'Institut für Klinisch-Onkologische Forschung (IKF), Krankenhaus Nordwest gGmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Ulli Simone', 'Initials': 'US', 'LastName': 'Bankstahl', 'Affiliation': 'Institut für Klinisch-Onkologische Forschung (IKF), Krankenhaus Nordwest gGmbH, Frankfurt am Main, Germany. Bankstahl.ulli@khnw.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Keck', 'Affiliation': 'Klinik für Chirurgie, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Königsrainer', 'Affiliation': 'Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinik Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sven A', 'Initials': 'SA', 'LastName': 'Lang', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pauligk', 'Affiliation': 'Institut für Klinisch-Onkologische Forschung (IKF), Krankenhaus Nordwest gGmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Pompiliu', 'Initials': 'P', 'LastName': 'Piso', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Barmherzige Brüder Regensburg, Regensburg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institut für Klinisch-Onkologische Forschung (IKF), Krankenhaus Nordwest gGmbH, Frankfurt am Main, Germany.'}]",BMC cancer,['10.1186/s12885-020-6610-4']
828,32413250,Implementing Active Support in disability day services: A 6-month prospective study on engagement and behaviours of concern among adults with intellectual disability.,"BACKGROUND


Adults with intellectual disability are often disengaged in disability services. While Active Support has found efficacy in residential settings, less is known in day services. This study examines the impact of Active Support in day services for adults with intellectual disability in Singapore, particularly on engagement and behaviours of concern.
METHOD


An experimental design was used, with a group of 32 participants receiving an Active Support programme over 6 months, compared to a control group of 16 participants with treatment as usual. Time sampling of behaviours was conducted every 4 weeks.
RESULTS


The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
CONCLUSION


Results support the implementation of Active Support across other day services for adults with intellectual disability. Active Support principles should be considered in planning policies and service outcome measures.",2020,"The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
","['adults with intellectual disability in Singapore, particularly on engagement and behaviours of concern', '32 participants receiving an', 'Adults with intellectual disability', 'adults with intellectual disability']",['Active Support programme'],"['activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",16.0,0.0621839,"The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
","[{'ForeName': 'Jiayong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Vimallan', 'Initials': 'V', 'LastName': 'Manokara', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Jesselyn S', 'Initials': 'JS', 'LastName': 'Ng', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Sivananda', 'Initials': 'S', 'LastName': 'Penchaliah', 'Affiliation': 'MINDS, Singapore.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12750']
829,31568890,The efficacy of maxillary and mandibular nerve blockade using electrical nerve stimulation for guidance.,"BACKGROUND


In oral and maxillofacial surgical procedures, sometimes conventional loco-regional anesthesia techniques could be insufficient in daily clinical practice. The aim of this study was to evaluate the efficacy of analgesia using electrical nerve stimulation (ENS) for maxillary or mandibular nerve blockade, in comparison with conventional loco-regional anesthesia techniques.
METHODS


The study comprised 52 patients who were attending the department for advanced surgery of the upper and lower jaw. Patients were randomly divided into 2 groups: ENS and Local group. The predictor variable was the anesthesia technique (ENS and Local groups). The outcome variables were patient assessed pain levels (VAS scores) and total anesthetic dose.
RESULTS


Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
CONCLUSIONS


Maxillary and mandibular nerve blockade is more efficient with ENS guidance, with lower amounts of anesthetic required, compared to conventional loco-regional anesthesia.",2020,"Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
",['52 patients who were attending the department for advanced surgery of the upper and lower jaw'],"['analgesia using electrical nerve stimulation (ENS', 'Maxillary and Mandibular Nerve Blockade Using Electrical Nerve Stimulation', 'ENS and Local group']","['pain levels', 'pain levels (VAS scores) and total anesthetic dose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460026', 'cui_str': 'Mandibular region'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0024695', 'cui_str': 'Mandibular Nerve'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",52.0,0.0331612,"Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bayramoğlu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ataturk University, Erzurum, Turkey. Electronic address: zeynep0569@hotmail.com.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Yavuz', 'Affiliation': 'Private Practice, Oral and Maxillofacial Surgery, Bursa, Turkey. Electronic address: mselimyavuz@gmail.com.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.09.007']
830,31597690,Previsit Screening for Parental Vaccine Hesitancy: A Cluster Randomized Trial.,"OBJECTIVE


To evaluate the effect of vaccine hesitancy screening on childhood vaccine uptake.
METHODS


We conducted a cluster randomized controlled trial in pediatric primary care clinics in Washington state. Vaccine-hesitant parents (VHPs) with a healthy newborn receiving health supervision at participating clinics were eligible. VHPs were identified by using a 4-item version of the validated Parent Attitudes About Childhood Vaccines Survey (PACV). Before their child's 2- and 6-month health supervision visits, VHPs at intervention clinics completed the 15-item PACV embedded in a survey containing placebo items. Intervention providers received a summary of parents' 15-item PACV responses and interpretation of their PACV score; discretion was given to providers regarding how they acted on this information. VHPs at control clinics completed only the placebo survey items, and their child's provider received a summary of their responses; control providers remained blinded to parent VHP status. Our outcome was child immunization status at 8 months of age expressed as percent of days underimmunized. We compared outcomes in control and intervention participants using  t  test and linear mixed-effects regression.
RESULTS


We enrolled 24 clinics (12 in each arm) and 156 parents (65 in the intervention arm). Parent characteristics were similar across arms except more intervention (versus control) parents had a first-born child (60.9% vs 44%;  P  = .04). No significant difference in outcome was detected between arms (25.2% [95% confidence interval: 16.0% to 34.5%] vs 19.1% [95% confidence interval: 12.0% to 26.3%] mean days underimmunized in the intervention and control arms, respectively).
CONCLUSION


Vaccine hesitancy screening was not significantly associated with days underimmunized.",2019,"No significant difference in outcome was detected between arms (25.2% [95% confidence interval: 16.0% to 34.5%] vs 19.1% [95% confidence interval: 12.0% to 26.3%] mean days underimmunized in the intervention and control arms, respectively).
","['healthy newborn receiving health supervision at participating clinics were eligible', 'We enrolled 24 clinics (12 in each arm) and 156 parents (65 in the intervention arm', 'pediatric primary care clinics in Washington state']","['vaccine hesitancy screening', 'Previsit Screening for Parental Vaccine Hesitancy', 'Vaccine-hesitant parents (VHPs']",[],"[{'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],24.0,0.353529,"No significant difference in outcome was detected between arms (25.2% [95% confidence interval: 16.0% to 34.5%] vs 19.1% [95% confidence interval: 12.0% to 26.3%] mean days underimmunized in the intervention and control arms, respectively).
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; douglas.opel@seattlechildrens.org.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Henrikson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lepere', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hawkes', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Washington, Seattle, Washington; and.'}]",Pediatrics,['10.1542/peds.2019-0802']
831,31687047,The Effect of Brief Mindfulness Training on Brain Reactivity to Food Cues During Nicotine Withdrawal: A Pilot Functional Imaging Study.,"Objectives


Many individuals who smoke relapse due to weight gain. Mindfulness training has been shown to help smokers quit smoking, and, in other populations, has been used to help people lose weight. This study was designed to assess the effect of one week of mindfulness practice on food cravings in smokers during 12-hour smoking abstinence.
Methods


We assessed daily smokers with a history of smoking lapse after weight gain. Participants were provided with brief training in mindfulness meditation and mindful eating and were asked to practice each skill daily for one week. Before and after this week of mindfulness practice, participants completed surveys to rate their nicotine dependence and food cravings and underwent testing via functional magnetic resonance imaging.
Results


Study results included pre-post intervention reduction in brain activity in dorsomedial prefrontal cortex, visual areas, and pre-motor areas, regions potentially associated with response to food images.
Conclusions


The study was small; however, it suggests the possibility that mindfulness training might be used to decrease food cravings after smoking cessation.",2019,"Before and after this week of mindfulness practice, participants completed surveys to rate their nicotine dependence and food cravings and underwent testing via functional magnetic resonance imaging.
","['daily smokers with a history of smoking lapse after weight gain', 'smokers during 12-hour smoking abstinence', 'individuals who smoke relapse due to weight gain']","['nicotine dependence and food cravings and underwent testing via functional magnetic resonance imaging', 'Mindfulness training', 'Brief Mindfulness Training', 'brief training in mindfulness meditation and mindful eating']","['food cravings', 'brain activity in dorsomedial prefrontal cortex, visual areas, and pre-motor areas, regions potentially associated with response to food images', 'Brain Reactivity to Food Cues']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0150277'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.0188737,"Before and after this week of mindfulness practice, participants completed surveys to rate their nicotine dependence and food cravings and underwent testing via functional magnetic resonance imaging.
","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Kragel', 'Affiliation': 'Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC 27858.'}, {'ForeName': 'Maggie M', 'Initials': 'MM', 'LastName': 'Sweitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, 2608 Erwin Road, Durham NC, 27705.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Duke Center for Smoking Cessation, Duke University School of Medicine, 2424 Erwin Road, Suite 201, Durham, NC 27705, USA.'}]",Mindfulness,['10.1007/s12671-019-01201-y']
832,32413915,Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial.,"BACKGROUND


The optimal sampling techniques for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) remain unclear and have not been standardized. The aim of this study was to compare the wet-suction and dry-suction techniques for sampling solid lesions in the pancreas, mediastinum, and abdomen.
METHODS


This was a multicenter, crossover, randomized controlled trial with randomized order of sampling techniques. The 296 consecutive patients underwent EUS-FNA with 22G needles and were randomized in a ratio of 1:1 into two separate groups that received the dry-suction and wet-suction techniques in a different order. The primary outcome was to compare the histological diagnostic accuracy of dry suction and wet suction for malignancy. The secondary outcomes were to compare the cytological diagnostic accuracy and specimen quality.
RESULTS


Among the 269 patients with pancreatic (n = 161) and non-pancreatic (n = 108) lesions analyzed, the wet-suction technique had a significantly better histological diagnostic accuracy (84.9 % [95 % confidence interval (CI) 79.9 % - 89.0 %] vs. 73.2 % [95 %CI 67.1 % - 78.7 %];  P  = 0.001), higher specimen adequacy (94.8 % vs. 78.8 %;  P  < 0.001), and less blood contamination ( P  < 0.001) than the dry-suction technique. In addition, sampling non-pancreatic lesions with two passes of wet suction provided a histological diagnostic accuracy of 91.6 %.
CONCLUSIONS


The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. Furthermore, sampling non-pancreatic lesions with two passes of EUS-FNA with wet suction may provide a definitive histological diagnosis when rapid on-site evaluation is not routinely available.",2020,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"['296 consecutive patients underwent EUS-FNA with 22G needles', '269 patients with pancreatic (n\u200a=\u200a161) and non-pancreatic (n\u200a=\u200a108) lesions']","['endoscopic ultrasound-guided fine-needle aspiration', 'endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA', 'dry-suction techniques', 'dry-suction and wet-suction techniques', 'wet-suction and dry-suction techniques']","['blood contamination', 'histological diagnostic accuracy and specimen quality', 'histological diagnostic accuracy of dry suction and wet suction for malignancy', 'higher specimen adequacy', 'histological diagnostic accuracy', 'cytological diagnostic accuracy and specimen quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}]",296.0,0.146063,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Rong-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shi-Yun', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ya-Qi', 'Initials': 'YQ', 'LastName': 'Duan', 'Affiliation': 'Institute of Pathology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang-Ru', 'Initials': 'LR', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ji-Wang', 'Initials': 'JW', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yu-Chong', 'Initials': 'YC', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shou-Jiang', 'Initials': 'SJ', 'LastName': 'Tang', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Endoscopy,['10.1055/a-1167-2214']
833,27716691,The efficacy of pre-emptive dexmedetomidine versus amiodarone in preventing postoperative junctional ectopic tachycardia in pediatric cardiac surgery.,"OBJECTIVE


The objective of this study was to assess the effectiveness of pre-emptive dexmedetomidine versus amiodarone in preventing junctional ectopic tachycardia (JET) in pediatric cardiac surgery.
DESIGN


This is a prospective, controlled study.
SETTING


This study was carried out at a single university hospital.
SUBJECTS AND METHODS


Ninety patients of both sexes, American Society of Anesthesiologists Physical Status II and III, age range from 2 to 18 years, and scheduled for elective cardiac surgery for congenital and acquired heart diseases were selected as the study participants.
INTERVENTIONS


Patients were randomized into three groups (30 each). Group I received dexmedetomidine 1 mcg/kg diluted in 100 ml of normal saline intravenously (IV) over a period of 20 min, and the infusion was completed 10 min before the induction followed by a 0.5 mcg/kg/h infusion for 72 h postoperative, Group II received amiodarone 5 mg/kg diluted in 100 ml of normal saline IV over a period of 20 min, and the infusion was completed 10 min before the induction followed by a 10-15 mcg/kg/h infusion for 72 h postoperative, and Group III received 100 ml of normal saline IV. Primary outcome was the incidence of postoperative JET. Secondary outcomes included vasoactive-inotropic score, ventilation time (VT), pediatric cardiac care unit stay, hospital length of stay, and perioperative mortality.
MEASUREMENTS AND MAIN RESULTS


The incidence of JET was significantly reduced in Group I and Group II (P = 0.004) compared to Group III. Heart rate while coming off from cardiopulmonary bypass (CPB) was significantly low in Group I compared to Group II and Group III (P = 0.000). Mean VT, mean duration of Intensive Care Unit stay, and length of hospital stay (day) were significantly short (P = 0.000) in Group I and Group II compared to Group III (P = 0.000).
CONCLUSION


Perioperative use of dexmedetomidine and amiodarone is associated with significantly decreased incidence of JET as compared to placebo without significant side effects.",2016,The incidence of JET was significantly reduced in Group I and Group II (P = 0.004) compared to Group III.,"['Ninety patients of both sexes, American Society of Anesthesiologists Physical Status II and III, age range from 2 to 18 years, and scheduled for elective cardiac surgery for congenital and acquired heart diseases were selected as the study participants', 'pediatric cardiac surgery', 'This study was carried out at a single university hospital']","['placebo', 'dexmedetomidine 1 mcg/kg diluted in 100 ml of normal saline', 'pre-emptive dexmedetomidine', 'amiodarone', 'amiodarone 5 mg/kg diluted in 100 ml of normal saline IV', 'dexmedetomidine']","['Heart rate', 'incidence of postoperative JET', 'incidence of JET', 'Mean VT, mean duration of Intensive Care Unit stay, and length of hospital stay (day', 'vasoactive-inotropic score, ventilation time (VT), pediatric cardiac care unit stay, hospital length of stay, and perioperative mortality', 'junctional ectopic tachycardia (JET', 'postoperative junctional ectopic tachycardia']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care treatments and procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0039235', 'cui_str': 'Tachycardia, Ectopic Junctional'}]",,0.0556146,The incidence of JET was significantly reduced in Group I and Group II (P = 0.004) compared to Group III.,"[{'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'El-Shmaa', 'Affiliation': 'Department of Anesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'El Amrousy', 'Affiliation': 'Department of Pediatrics, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'El Feky', 'Affiliation': 'Department of Cardiothoracic Surgery, Tanta University Hospital, Tanta, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/0971-9784.191564']
834,29762717,Durable complete responses in some recurrent high-grade glioma patients treated with Toca 511 + Toca FC.,"Background


Vocimagene amiretrorepvec (Toca 511) is an investigational gamma-retroviral replicating vector encoding cytosine deaminase that, when used in combination with extended-release 5-fluorocytosine (Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity. Recurrent high-grade glioma (rHGG) patients have a high unmet need for effective therapies that produce durable responses lasting more than 6 months. In this setting, relapse is nearly universal and most responses are transient.
Methods


In this Toca 511 ascending-dose phase I trial (NCT01470794), HGG patients who recurred after standard of care underwent surgical resection and received Toca 511 injected into the resection cavity wall, followed by orally administered cycles of Toca FC.
Results


Among 56 patients, durable complete responses were observed. A subgroup was identified based on Toca 511 dose and entry requirements for the follow-up phase III study. In this subgroup, which included both isocitrate dehydrogenase 1 (IDH1) mutant and wild-type tumors, the durable response rate is 21.7%. Median duration of follow-up for responders is 35.7+ months. As of August 25, 2017, all responders remain in response and are alive 33.9+ to 52.2+ months after Toca 511 administration, suggesting a positive association of durable response with overall survival.
Conclusions


Multiyear durable responses have been observed in rHGG patients treated with Toca 511 + Toca FC in a phase I trial, and the treatment will be further evaluated in a randomized phase III trial. Among IDH1 mutant patients treated at first recurrence, there may be an enrichment of complete responders.",2018,"(Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity.","['patients who recurred after standard of care underwent', '56 patients', 'Recurrent high-grade glioma (rHGG) patients']","['surgical resection and received Toca 511 injected into the resection cavity wall, followed by orally administered cycles of Toca FC', '5-fluorocytosine', 'HGG']","['durable response rate', 'Median duration', 'local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016278', 'cui_str': 'Flucytosine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0887899', 'cui_str': 'Myeloid Cells'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",,0.0285941,"(Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity.","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Landolfi', 'Affiliation': 'New Jersey Neuroscience Institute, JFK Brain Tumor Center, Edison, New Jersey.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ostertag', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Elder', 'Affiliation': 'Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bloomfield', 'Affiliation': 'New Jersey Neuroscience Institute, JFK Brain Tumor Center, Edison, New Jersey.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Clark C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Kalkanis', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kesari', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lai', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Ian Y', 'Initials': 'IY', 'LastName': 'Lee', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Liau', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mikkelsen', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Phioanh', 'Initials': 'P', 'LastName': 'Nghiemphu', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piccioni', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Accomando', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Oscar R', 'Initials': 'OR', 'LastName': 'Diago', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hogan', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Gammon', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kasahara', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Thian', 'Initials': 'T', 'LastName': 'Kheoh', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Jolly', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Gruber', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}]",Neuro-oncology,['10.1093/neuonc/noy075']
835,31807943,Does helping mothers in multigenerational ADHD also help children in the long run? 2-year follow-up from baseline of the AIMAC randomized controlled multicentre trial.,"ADHD often affects multiple generations in a family. Previous studies suggested that children with ADHD benefit less from therapy if parents are also affected, since ADHD symptoms interfere with treatment implementation. This two-group randomised controlled trial examined whether targeting maternal ADHD boosts the efficacy of parent-child training (PCT) for the child's ADHD. Here, we report follow-up results 2 years from baseline. Mothers of 144 mother-child dyads (ADHD according to DSM-IV) were examined for eligibility (T1) and randomised to 12 weeks of intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n = 77) or clinical management comprising non-specific counselling (CG, n = 67) for Step 1 (concluded by T2). Subsequently, all dyads participated in 12 weekly PCT sessions for Step 2 (concluded by T3). In Step 3, participants received maintenance treatments for 6 months (concluded by T4). At 24 months after baseline (T5), we performed follow-up assessments. The primary endpoint was child ADHD/ODD score (observer blind rating). Outcomes at T5 were evaluated using ANCOVA. Assessments from 101 children and 95 mothers were available at T5. Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1). The maternal advantage of TG over CG on the CAARS-O:L ADHD index (range 0-36) disappeared at T5 (mean difference = 0.2; 95% CI - 2.3 to 2.6). Sensitivity analyses controlling for medication and significant predictors of follow-up participation showed unchanged outcomes. Within-group outcomes remained improved from baseline. At the 24-month follow-up, TG and CG converged. The superiority of intensive treatment regarding maternal symptoms disappeared. In general, cross-generational treatment seems to be effective in the long term. (BMBF grant 01GV0605; registration ISRCTN73911400).",2020,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"['101 children and 95 mothers', 'Mothers of 144 mother-child dyads (ADHD according to DSM-IV']","['parent-child training (PCT', 'intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n\u2009=\u200977) or clinical management comprising non-specific counselling (CG, n\u2009=\u200967) for Step 1 (concluded by T2']","['Adjusted means (m) of ADHD/ODD symptoms', 'child ADHD/ODD score (observer blind rating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",144.0,0.156423,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Geissler', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany. Geissler_J@ukw.de.'}, {'ForeName': 'Timo D', 'Initials': 'TD', 'LastName': 'Vloet', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Strom', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jaite', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Kappel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hennighausen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haack-Dees', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schneider-Momm', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rösler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Hänig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Gontard', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hohmann', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Poustka', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gentschow', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Hospital for Child and Adolescent Psychiatry, LWL University Hospital Hamm of the Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01451-0']
836,28106552,Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.,"BACKGROUND


While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise.
OBJECTIVES


In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease.
METHODS


Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)].
RESULTS


The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors.
CONCLUSIONS


Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.",2017,"Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04).","['Adults with Subjective Cognitive Decline', 'Sixty participants with SCD', 'adults with SCD', 'adults experiencing subjective cognitive decline (SCD']","['KK or ML program', 'Meditation and Music Improve Memory and Cognitive Function', 'Kirtan Kriya meditation (KK) and music listening (ML']","['overall gains', 'cognitive outcomes', 'memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST', ""memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04"", 'subjective memory function and objective cognitive performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0150277'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",60.0,0.136699,"Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04).","[{'ForeName': 'Kim E', 'Initials': 'KE', 'LastName': 'Innes', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, WV, USA.'}, {'ForeName': 'Terry Kit', 'Initials': 'TK', 'LastName': 'Selfe', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, WV, USA.'}, {'ForeName': 'Dharma Singh', 'Initials': 'DS', 'LastName': 'Khalsa', 'Affiliation': 'Department of Internal Medicine and Integrative Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Sahiti', 'Initials': 'S', 'LastName': 'Kandati', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, WV, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-160867']
837,31566239,"Association of Tobacco Use During Pregnancy, Perceived Stress, and Depression Among Alaska Native Women Participants in the Healthy Pregnancies Project.","INTRODUCTION


In general population samples, higher levels of stress and depression have been associated with increased prevalence of smoking in pregnancy. Little is known about the association of prenatal tobacco use, stress, and depression among American Indian or Alaska Native (AI/AN) women.
METHODS


The Healthy Pregnancies Project is a cluster-randomized controlled trial, evaluating a community-level intervention compared with usual care, for reducing tobacco use during pregnancy and postpartum among AN women in 16 villages in western Alaska. This cross-sectional study analyzed baseline data from enrolled pregnant women. Baseline measures included the self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D). Generalized estimating equations (GEE) analyses adjusted for village, participant age, and gestational age.
RESULTS


Participants (N = 352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation. 66.5% were current tobacco users, of which 77% used Iqmik, a homemade form of smokeless tobacco. Compared with nonusers, tobacco users reported lower PSS score (p = .020) and less clinical levels of depression (CES-D ≥ 16) (18.1% vs. 9.3%, p = .21). Findings were not accounted for by nicotine dependence severity or self-reported tobacco use before pregnancy.
CONCLUSIONS


In this sample of pregnant AN women, tobacco users report less stress and clinical levels of depression than nonusers. A potential challenge with tobacco treatment for pregnant AN women is to provide alternative ways of deescalating stress and affect management instead of using tobacco.
IMPLICATIONS


This study contributes novel information on the association of tobacco use, perceived stress, and depression among Alaska Native women enrolled in a clinical trial to promote healthy pregnancies. Most prior studies addressing this topic were conducted among general population samples of pregnant women who smoked cigarettes. Little is known about these associations with prenatal smokeless tobacco, or among American Indian or Alaska Native women. The results are contrary to findings reported previously, because current tobacco use was associated with less stress and depression than nonuse. The study findings have implications for cessation treatment for this tobacco-use disparity group.",2020,"Compared with non-users, tobacco users reported lower PSS score (p=0.020) and less clinical levels of depression (CES-D ≥16) (18.1% vs. 9.3%, p=0.21).","['Alaska Native Women Participants in the Healthy Pregnancies Project', 'during pregnancy and postpartum among AN women in 16 villages in western Alaska', 'pregnant AN women', 'American Indian or Alaska Native women', 'Alaska Native women enrolled in a clinical trial to promote healthy pregnancies', 'Participants (N=352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation', 'enrolled pregnant women', 'pregnant women who smoked cigarettes', 'American Indian or Alaska Native (AI/AN) women']","['community-level intervention compared with usual care, for reducing tobacco use']","['PSS score', 'clinical levels of depression', 'stress and depression', 'self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D']","[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native (racial group)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}]",,0.059071,"Compared with non-users, tobacco users reported lower PSS score (p=0.020) and less clinical levels of depression (CES-D ≥16) (18.1% vs. 9.3%, p=0.21).","[{'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Lando', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Desnoyers', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Klejka', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Decker', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Alexie', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Rahnia', 'Initials': 'R', 'LastName': 'Boyer', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Burhansstipanov', 'Affiliation': 'Native American Cancer Initiatives, Inc., Pine, CO.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz189']
838,32415471,Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial.,"PURPOSE


Primary dysmenorrhea is the most common gynecological problem in young women and adolescents. Exercise therapy provides positive effects on women with primary dysmenorrhea. The aim of the study was to investigate the effects of a combined exercise program on pain, sleep and menstrual symptoms in patients with primary dysmenorrhea.
METHODS


The study is a randomized controlled study. The study included 28 sedentary individuals. The participants were assigned to two groups as the exercise (mean age 22.9 ± 2.0 years) and the control (mean age 23.1 ± 1.8 years) groups. The exercise protocol was carried out with the exercise group three times a week for eight weeks. The Visual Analog Scale (VAS) was used for assessing the intensity of pain. The Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI) were used for evaluating menstrual symptoms and sleep quality, respectively. The study was registered on the Clinical Trials website by the number NCT03625375.
RESULTS


The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05). The intragroup comparisons of the exercise group demonstrated that the scores of the low back pain and abdominal pain and the MSQ and PSQI scores were found to be significantly different after the 8-week program (p < 0.05).
CONCLUSION


The combined exercise therapy is an effective way to manage symptoms associated with primary dysmenorrhea.",2020,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","['young women and adolescents', 'patients with primary dysmenorrhea', 'women with primary dysmenorrhea', '28 sedentary individuals']","['functional exercises', 'combined exercise program', 'Exercise therapy', 'combined exercise therapy']","['Visual Analog Scale (VAS', 'Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI', 'low back pain and abdominal pain and the MSQ and PSQI scores', 'pain, sleep and menstrual symptoms', 'abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods', 'menstrual symptoms and sleep quality', 'pain and sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",28.0,0.0352192,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","[{'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey. berkiye.kirmizigil@emu.edu.tr.'}, {'ForeName': 'Cisel', 'Initials': 'C', 'LastName': 'Demiralp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05579-2']
839,32416251,Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer.,"BACKGROUND


Alpelisib (α-selective phosphatidylinositol 3-kinase inhibitor) plus fulvestrant is approved in multiple countries for men and postmenopausal women with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer following progression on or after endocrine therapy. A detailed understanding of alpelisib's safety profile should inform adverse event (AE) management and enhance patient care.
PATIENTS AND METHODS


AEs in the phase III SOLAR-1 trial were assessed in patients with and without PIK3CA mutations. The impact of protocol-specified AE-management recommendations was evaluated, including an amendment to optimize hyperglycemia and rash management.
RESULTS


Patients were randomly assigned to receive fulvestrant plus alpelisib (n = 284) or placebo (n = 287). The most common grade 3/4 AEs with alpelisib were hyperglycemia (grade 3, 32.7%; grade 4, 3.9%), rash (grade 3, 9.9%), and diarrhea (grade 3, 6.7%). Median time to onset of grade ≥3 toxicity was 15 days (hyperglycemia, based on fasting plasma glucose), 13 days (rash), and 139 days (diarrhea). Metformin alone or in combination with other antidiabetic agents was used by most patients (87.1%) with hyperglycemia. Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% versus 64.1%) and severity of rash (grade 3, 11.6% versus 22.7%) versus no preventative medication. Discontinuations due to grade ≥3 AEs were lower following more-detailed AE management guidelines (7.9% versus 18.1% previously). Patients with PIK3CA mutations had a median alpelisib dose intensity of 248 mg/day. Median progression-free survival with alpelisib was 12.5 and 9.6 months for alpelisib dose intensities of ≥248 mg/day and <248 mg/day, respectively, compared with 5.8 months with placebo.
CONCLUSIONS


Hyperglycemia and rash occurred early during alpelisib treatment, while diarrhea occurred at a later time point. Early identification, prevention, and intervention, including concomitant medications and alpelisib dose modifications, resulted in less severe toxicities. Reductions in treatment discontinuations and improved progression-free survival at higher alpelisib dose intensities support the need for optimal AE management. CLINICALTRIALS.
GOV ID


NCT02437318.",2020,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","['Patients With HR-Positive Advanced Breast Cancer', 'AEs in the phase 3 SOLAR-1 trial were assessed in patients with and without PIK3CA mutations', 'multiple countries for men and post-menopausal women with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after endocrine therapy']","['Metformin', 'Alpelisib (α-selective PI3K inhibitor) plus fulvestrant', 'fulvestrant plus alpelisib', 'PI3K Inhibitor Alpelisib Plus Fulvestrant', 'placebo']","['diarrhea', 'median alpelisib dose intensity', 'PFS', 'Hyperglycemia and rash', 'Time Course and Management of Key Adverse Events', 'Median time to onset of grade ≥3 toxicity', 'Median progression-free survival (PFS', 'rash', 'severe toxicities', 'hyperglycemia', 'severity of rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.111823,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA. Electronic address: Hope.Rugo@ucsf.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, INSERM U981, Gustave Roussy, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cerda', 'Affiliation': 'Clinica RedSalud Vitacura, Santiago, Chile.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Toledano', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': 'Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Jurado', 'Affiliation': 'Hospital Universitario Canarias, S/C Tenerife, Islas Canarias, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Hematology and Oncology, Vanderbilt University, Nashville, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Breast Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padua and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, St Herblain, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lteif', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gaudenzi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medicine and Research, German Breast Group, Neu-Isenburg; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.001']
840,31576625,Impact of a pharmacist-led education and follow-up service on anticoagulation control and safety outcomes at a tertiary hospital in China: a randomised controlled trial.,"OBJECTIVES


This study was designed to evaluate the impact of a pharmacist-led anticoagulation service on international normalised ratio (INR) control and other outcomes among patients receiving warfarin therapy at a tertiary hospital in Zhuhai, China.
METHODS


In this randomised controlled trial, adult patients who were newly initiated on warfarin with intended treatment duration of at least 3 months were recruited. Participants were randomly allocated to receive the pharmacist-led education and follow-up service (PEFS) or usual care (UC). Anticoagulation control was calculated as the proportions of time within the target INR range (TTR) and time within the expanded target range (TER).
KEY FINDINGS


A total of 152 participants (77 in the PEFS group and 75 in the UC group) were included. Within 180 days after hospital discharge, the PEFS group spent more TER than the UC group (54.4% versus 42.0%; P = 0.024), whereas the difference in TTR did not reach statistical significance (35.9% versus 29.5%; P = 0.203). No major bleeding events were observed, and the cumulative incidences of major thromboembolic events (6.5% versus 9.3%) and mortality (1.3% versus 1.3%) were similar between the two groups (P> 0.05). At 30 days postdischarge, the PEFS group had better warfarin knowledge by answering 57.5% of questions correctly, compared with the UC group (43.0%) (P = 0.003).
CONCLUSIONS


The PEFS markedly enhanced anticoagulation control and warfarin knowledge but there was room for improvement. The expansion of pharmacists' clinical role and the development of more effective education and follow-up strategies are warranted to optimise anticoagulation management services in China.",2020,"No major bleeding events were observed, and the cumulative incidences of major thromboembolic events (6.5% versus 9.3%) and mortality (1.3% versus 1.3%) were similar between the two groups (P> 0.05).","['patients receiving warfarin therapy at a tertiary hospital in Zhuhai, China.\nMETHODS', 'tertiary hospital in China', 'adult patients who were newly initiated on warfarin with intended treatment duration of at least 3\xa0months were recruited', '152 participants (77 in the PEFS group and 75 in the UC group) were included']","['pharmacist-led anticoagulation service', 'PEFS', 'pharmacist-led education and follow-up service (PEFS) or usual care (UC', 'pharmacist-led education and follow-up service']","['mortality', 'proportions of time within the target INR range (TTR) and time within the expanded target range (TER', 'major bleeding events', 'warfarin knowledge', 'cumulative incidences of major thromboembolic events', 'anticoagulation control and warfarin knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3887424', 'cui_str': 'Anticoagulation service'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",152.0,0.11495,"No major bleeding events were observed, and the cumulative incidences of major thromboembolic events (6.5% versus 9.3%) and mortality (1.3% versus 1.3%) were similar between the two groups (P> 0.05).","[{'ForeName': 'Jia-Bi', 'Initials': 'JB', 'LastName': 'Liang', 'Affiliation': 'Department of Pharmacy, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, China.'}, {'ForeName': 'Cheng-Kin', 'Initials': 'CK', 'LastName': 'Lao', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao S.A.R., China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, China.'}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong Province, China.'}, {'ForeName': 'Henry Hoi-Yee', 'Initials': 'HH', 'LastName': 'Tong', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao S.A.R., China.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore, Singapore.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12584']
841,31499240,Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention.,"BACKGROUND


This study investigated the effects of a multi-level smoking intervention on mediators of long-term abstinence in parental smokers, including smoking cessation self-efficacy, smoking urge coping, and perceived support to quit smoking.
METHODS


This is a secondary analysis of data from a randomized trial that recruited parental smokers from pediatric clinics in low-income communities (N = 327, 83% women, 83% African American, 79% below poverty level). Following clinical practice guidelines for tobacco intervention (""Ask, Advise, Refer"" [AAR]), pediatricians asked all parents about child tobacco smoke exposure (TSE), advised about TSE harms and benefits of reducing TSE, and referred smokers to cessation resources. Eligible parents were then randomized to additional telephone-based smoking behavior counseling (AAR + counseling) or nutrition education (AAR + control). Bioverified 7-day point prevalence smoking abstinence and perceived counselor support were assessed at 12-month follow-up; cessation self-efficacy and urge coping were assessed at 3-month follow-up.
RESULTS


Relative to AAR + control, AAR + counseling was associated with higher self-efficacy, urge coping, and perceived support to quit (all p's<.001). Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001). The indirect effect of intervention on 12-month abstinence via self-efficacy suggested mediation via this pathway (p = .002).
CONCLUSION


Results suggest that all putative treatment pathways were improved more by the multi-level AAR + counseling than the clinic-level AAR + control intervention. Further, self-efficacy at end-of-treatment prospectively predicted long-term cessation, suggesting that building of self-efficacy through treatment may be key to sustained cessation.",2019,"Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001).","['parental smokers', 'recruited parental smokers from pediatric clinics in low-income communities (N\u2009=\u2009327, 83% women, 83% African American, 79% below poverty level', 'low-income parents in the multilevel Kids Safe and Smokefree intervention', 'Eligible parents']","['telephone-based smoking behavior counseling (AAR\u2009+\u2009counseling) or nutrition education (AAR\u2009+\u2009control', 'multi-level smoking intervention']","['cessation self-efficacy and urge coping', 'higher self-efficacy, urge coping, and perceived support to quit', 'smoking cessation self-efficacy, smoking urge coping', '12-month bioverified smoking abstinence', 'Self-efficacy']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0254556,"Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Ave, 9th Floor Ritter Annex, Philadelphia, PA 19122, USA. Electronic address: slepore@temple.edu.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Ave, 9th Floor Ritter Annex, Philadelphia, PA 19122, USA. Electronic address: collinsb@temple.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sosnowski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 W. Franklin St, Box 842018, Richmond, VA 23284, USA. Electronic address: sosnowskid@mymail.vcu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.05.027']
842,32416781,"Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous immunosuppressive therapy within the 30 days before study drug administration. Eligible patients were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or double-matching placebo group. The primary endpoint was the recurrence-free survival in the intention-to-treat population. The results presented in this report reflect the prespecified interim analysis of recurrence-free survival after 90 events had been reported. This study is registered with ClinicalTrials.gov, NCT02523313, and is ongoing.
FINDINGS


Between Sept 2, 2015, and Nov 20, 2018, 167 patients were randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52). As of July 2, 2019, at a median follow-up of 28·4 months (IQR 17·7-36·8), median recurrence-free survival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free survival was 12·4 months (95% CI 5·3-33·3) in the nivolumab group and 6·4 months (3·3-9·6) in the placebo group. The hazard ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0·23 (97·5% CI 0·12-0·45; p<0·0001), and for the nivolumab group versus placebo group was 0·56 (0·33-0·94; p=0·011). In the nivolumab plus ipilimumab group, recurrence-free survival at 1 year was 75% (95% CI 61·0-84·9) and at 2 years was 70% (55·1-81·0); in the nivolumab group, 1-year recurrence-free survival was 52% (38·1-63·9) and at 2 years was 42% (28·6-54·5); and in the placebo group, this rate was 32% (19·8-45·3) at 1 year and 14% (5·9-25·7) at 2 years. Treatment-related grade 3-4 adverse events were reported in 71% (95% CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivolumab group. Treatment-related adverse events of any grade led to treatment discontinuation in 34 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab group. Three deaths from adverse events were reported but were considered unrelated to the study treatment.
INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease. The rates of grade 3-4 treatment-related adverse events in both active treatment groups were higher than the rates reported in previous pivotal trials done in advanced melanoma with measurable disease.
FUNDING


Bristol-Myers Squibb.",2020,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","['patients with resected stage IV melanoma with no evidence of disease (IMMUNED', '20 German academic medical centres', 'Between Sept 2, 2015, and Nov 20, 2018, 167 patients', 'patients with stage IV melanoma with no evidence of disease', 'Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy', 'patients with advanced-ie, unresectable or metastatic-melanoma', 'Eligible patients']","['nivolumab alone or in combination with ipilimumab', 'adjuvant nivolumab plus ipilimumab', 'nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo', 'nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab', 'nivolumab', 'nivolumab plus ipilimumab', 'Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo', 'placebo']","['Treatment-related grade 3-4 adverse events', 'rates of grade 3-4 treatment-related adverse events', 'hazard ratio for recurrence', 'safety and efficacy', 'recurrence-free survival', '1-year recurrence-free survival', 'median recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",167.0,0.766829,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Livingstone', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fluck', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Friedegund', 'Initials': 'F', 'LastName': 'Meier', 'Affiliation': 'Department of Dermatology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermatology, Elbe-Kliniken, Buxtehude, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schilling', 'Affiliation': 'Department of Dermatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Menzer', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kieker', 'Affiliation': 'Department of Dermatology, Charité Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Dippel', 'Affiliation': 'Department of Dermatology, Ludwigshafen Medical Center, Ludwigshafen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rösch', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'Department of Dermatology, Leipzig University Hospital Medical Center, Leipzig, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Körner', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Schwarz', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen C', 'Initials': 'JC', 'LastName': 'Becker', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Translational Skin Cancer Research, German Cancer Consortium (DKTK), Partner Site Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30417-7']
843,31540607,Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder.,"BACKGROUND


Nationwide efforts seek to address the opioid epidemic by increasing access to medications for opioid use disorder (OUD), particularly with buprenorphine. A poorly understood challenge is that among individuals with OUD who do receive buprenorphine, many do not adhere to the pharmacotherapy long enough to achieve sustained benefits. We aimed to identify factors associated with buprenorphine treatment utilization over time.
METHODS


We used random-intercept modeling to identify factors associated with buprenorphine treatment utilization over 2 years after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of buprenorphine compared to methadone. Key predictors were participants' reports of buprenorphine treatment accessibility and acceptability (assessed at first follow-up) and their interaction effects, controlling for baseline randomization status, sociodemographics, and other covariates.
RESULTS


Approximately 9.3-11.2% of participants utilized buprenorphine treatment over the 2 years of follow-up. Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors. In contrast, individuals who perceived buprenorphine to be unacceptable were least likely to use buprenorphine, regardless the level of perceived access to the medication. Buprenorphine treatment utilization was also negatively associated with Hispanic ethnicity, West coast context, and cumulative months receiving methadone treatment and incarceration during follow-up.
CONCLUSIONS


To engage more individuals with OUD in long-term treatment with buprenorphine, interventions should target buprenorphine treatment acceptability, in addition to increasing buprenorphine access, and tailor efforts to meet the needs of vulnerable populations.
TRIAL REGISTRATION


The START Follow-up Study on ClinicalTrials.gov (NCT01592461).",2019,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","['over 2\u202fyears after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of', 'individuals with OUD', 'adults with opioid use disorder', '2\u202fyears']","['methadone', 'buprenorphine-naloxone', 'buprenorphine', 'Buprenorphine', 'buprenorphine treatment utilization']",['Interaction effects'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",789.0,0.0456768,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Evans', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, 312 Arnold House, 715 North Pleasant St. Amherst, MA 01003, USA. Electronic address: eaevans@umass.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: cyoo5@ucla.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhuang@ucla.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA 98108, USA. Electronic address: Andrew.Saxon@va.gov.'}, {'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhser@ucla.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.002']
844,26609167,"Vitamin D Supplementation Affects the Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress in Patients with Major Depressive Disorder: A Randomized, Controlled Clinical Trial.","BACKGROUND


Vitamin D may decrease depression symptoms through its beneficial effects on neurotransmitters, metabolic profiles, biomarkers of inflammation, and oxidative stress.
OBJECTIVE


This study was designed to assess whether vitamin D supplementation can reduce symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress in patients with major depressive disorder (MDD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was performed in 40 patients between 18 and 65 y of age with a diagnosis of MDD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders. Patients were randomly assigned to receive either a single capsule of 50 kIU vitamin D/wk (n = 20) or placebo (n = 20) for 8 wk. Fasting blood samples were taken at baseline and postintervention to quantify relevant variables. The primary [Beck Depression Inventory (BDI), which examines depressive symptoms] and secondary (glucose homeostasis variables, lipid profiles, hs-CRP, and biomarkers of oxidative stress) outcomes were assessed.
RESULTS


Baseline concentrations of mean serum 25-hydroxyvitamin D were significantly different between the 2 groups (9.2 ± 6.0 and 13.6 ± 7.9 μg/L in the placebo and control groups, respectively, P = 0.02). After 8 wk of intervention, changes in serum 25-hydroxyvitamin D concentrations were significantly greater in the vitamin D group (+20.4 μg/L) than in the placebo group (-0.9 μg/L, P < 0.001). A trend toward a greater decrease in the BDI was observed in the vitamin D group than in the placebo group (-8.0 and -3.3, respectively, P = 0.06). Changes in serum insulin (-3.6 compared with +2.9 μIU/mL, P = 0.02), estimated homeostasis model assessment of insulin resistance (-1.0 compared with +0.6, P = 0.01), estimated homeostasis model assessment of β cell function (-13.9 compared with +10.3, P = 0.03), plasma total antioxidant capacity (+63.1 compared with -23.4 mmol/L, P = 0.04), and glutathione (+170 compared with -213 μmol/L, P = 0.04) in the vitamin D group were significantly different from those in the placebo group.
CONCLUSION


Overall, vitamin D supplementation of patients with MDD for 8 wk had beneficial effects on the BDI, indicators of glucose homeostasis, and oxidative stress. This trial was registered at www.irct.ir as IRCT201412065623N29.",2016,"After 8 wk of intervention, changes in serum 25-hydroxyvitamin D concentrations were significantly greater in the vitamin D group (+20.4 μg/L) than in the placebo group (-0.9 μg/L, P < 0.001).","['patients with major depressive disorder (MDD', '40 patients between 18 and 65 y of age with a diagnosis of MDD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders', 'Patients with Major Depressive Disorder']","['placebo', 'vitamin D supplementation', 'Vitamin D Supplementation', 'vitamin D', 'single capsule of 50 kIU vitamin D']","['primary [Beck Depression Inventory (BDI), which examines depressive symptoms] and secondary (glucose homeostasis variables, lipid profiles, hs-CRP, and biomarkers of oxidative stress) outcomes', 'serum 25-hydroxyvitamin D concentrations', 'symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress', 'BDI', 'Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress', 'Changes in serum insulin', 'BDI, indicators of glucose homeostasis, and oxidative stress', 'mean serum 25-hydroxyvitamin D', 'estimated homeostasis model assessment of β cell function', 'Fasting blood samples', 'plasma total antioxidant capacity', 'estimated homeostasis model assessment of insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0439454', 'cui_str': 'kIU'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",40.0,0.684389,"After 8 wk of intervention, changes in serum 25-hydroxyvitamin D concentrations were significantly greater in the vitamin D group (+20.4 μg/L) than in the placebo group (-0.9 μg/L, P < 0.001).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sepehrmanesh', 'Affiliation': 'Department of Psychiatry and.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Kolahdooz', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abedi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazroii', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Assarian', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, and.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran; asemi_r@yahoo.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Food Security Research Center, and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran; and Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of nutrition,['10.3945/jn.115.218883']
845,26962106,Tetrahydrobiopterin ameliorates the exaggerated exercise pressor response in patients with chronic kidney disease: a randomized controlled trial.,"Chronic kidney disease (CKD) patients have an exaggerated increase in blood pressure (BP) during rhythmic handgrip exercise (RHG 20%) and static handgrip exercise (SHG 30%). Nitric oxide levels increase during exercise and help prevent excessive hypertension by both increasing vasodilation and reducing sympathetic nerve activity (SNA). Therefore, we hypothesized that tetrahydrobiopterin (BH4), an essential cofactor for nitric oxide synthase, would ameliorate the exaggerated exercise pressor response in CKD patients. In a randomized, double-blinded, placebo-controlled trial, we tested the effects of 12 wk of sapropterin dihydrochloride (6R-BH4; n = 18) versus placebo (n = 14) treatement on BP and muscle SNA (MSNA) responses during RHG 20% and SHG 30% in CKD patients. The 6R-BH4-treated group had a significantly lower systolic BP (+6 ± 1 vs. +13 ± 2 mmHg, P = 0.002) and mean arterial pressure response (+5 ± 1 vs. +10 ± 2 mmHg, P = 0.020) during RHG 20% and a significantly lower systolic BP response (+19 ± 3 vs. +28 ± 3 mmHg, P = 0.043) during SHG 30%. Under baseline conditions, there was no significant difference in MSNA responses between the groups; however, when the BP response during exercise was equalized between the groups using nitroprusside, the 6R-BH4-treated group had a significantly lower MSNA response during RHG 20% (6R-BH4 vs. placebo, +12 ± 1 vs. +21 ± 2 bursts/min, P = 0.004) but not during SHG 30%. These findings suggest that 6R-BH4 ameliorates the augmented BP response during RHG 20% and SHG 30% in CKD patients. A reduction in reflex activation of SNA may contribute to the decreased exercise pressor response during RHG 20% but not during SHG 30% in CKD patients.",2016,"Under baseline conditions, there was no significant difference in MSNA responses between the groups; however, when the BP response during exercise was equalized between the groups using nitroprusside, the 6R-BH4-treated group had a significantly lower MSNA response during RHG 20% (6R-BH4 vs. placebo, +12 ± 1 vs. +21 ± 2 bursts/min, P = 0.004) but not during SHG 30%.","['CKD patients', 'Chronic kidney disease (CKD) patients', 'patients with chronic kidney disease']","['placebo', 'tetrahydrobiopterin (BH4', 'rhythmic handgrip exercise (RHG 20%) and static handgrip exercise', 'sapropterin dihydrochloride', 'Tetrahydrobiopterin']","['exaggerated exercise pressor response', 'BP response during exercise', 'exercise pressor response', 'MSNA responses', 'BP and muscle SNA (MSNA) responses', 'BP response', 'systolic BP response', 'MSNA response', 'systolic BP', 'blood pressure (BP', 'mean arterial pressure response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4281712', 'cui_str': '5,6,7,8-erythro-tetrahydrobiopterin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1996349', 'cui_str': 'Sapropterin dihydrochloride'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",,0.0797682,"Under baseline conditions, there was no significant difference in MSNA responses between the groups; however, when the BP response during exercise was equalized between the groups using nitroprusside, the 6R-BH4-treated group had a significantly lower MSNA response during RHG 20% (6R-BH4 vs. placebo, +12 ± 1 vs. +21 ± 2 bursts/min, P = 0.004) but not during SHG 30%.","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Lin', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Research Service Line, Department of Veterans Affairs Medical Center, Decatur, Georgia;'}, {'ForeName': 'Peizhou', 'Initials': 'P', 'LastName': 'Liao', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia;'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Millson', 'Affiliation': 'Clinical Research Network, Atlanta Clinical and Translational Science Institute, Emory University School of Medicine, Atlanta, Georgia; and.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Cardiology Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Research Service Line, Department of Veterans Affairs Medical Center, Decatur, Georgia; jeanie.park@emory.edu.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00527.2015']
846,32026447,Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III.,"BACKGROUND/OBJECTIVE


Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
METHODS


In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
RESULTS


Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
CONCLUSIONS


Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.",2020,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.",['patients with dCT'],['WML'],"['absolute ICH expansion, ', 'ICH volume, intraventricular hemorrhage volume, warfarin/INR\u2009>\u20091.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location', 'Poor functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",635.0,0.141451,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.","[{'ForeName': 'Björn M', 'Initials': 'BM', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. nlullman@gmail.com.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Department of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-020-00916-4']
847,31022102,Tobacco Evidence-Based Practice Implementation and Employee Tobacco-Related Outcomes at Small Low-Wage Worksites.,"OBJECTIVE


The aim of this study was to assess whether tobacco policy, program, and communication evidence-based practice implementation is associated with employee tobacco outcomes [current smoking; quit attempt; smokeless tobacco (SLT) use; and perceived worksite support for cessation] at small low-wage worksites.
METHODS


We analyzed data from a randomized controlled trial testing an intervention to increase implementation of evidence-based health promotion practices. We used generalized estimating equations to examine relationships between practice implementation and tobacco outcomes.
RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027). Policy and program implementation were associated with increased odds of being a current SLT user; these findings should be interpreted with caution given small sample sizes.
CONCLUSION


Tobacco communication evidence-based practice implementation was associated with favorable perceptions of worksite support for cessation; more may be needed to change tobacco use behavior.",2019,"RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).",[],[],[],[],[],[],,0.15325,"RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Kava', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, University of Washington, Seattle, Washington (Dr Kava, Dr Harris, Ms Kohn, Ms Parrish, Dr Hannon), and Department of Biostatistics, University of Washington, Seattle, Washington (Dr Gary Chan).'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Kwun C', 'Initials': 'KC', 'LastName': 'Gary Chan', 'Affiliation': ''}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': ''}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001618']
848,31559463,Acute ACL reconstruction shows superior clinical results and can be performed safely without an increased risk of developing arthrofibrosis.,"PURPOSE


To compare acute ACL reconstruction (ACLR) within 8 days of injury with delayed reconstruction after normalized range of motion (ROM), 6-10 weeks after injury. It was hypothesized that acute ACL reconstruction with modern techniques is safe and can be beneficial in terms of patient-reported outcomes and range of motion.
METHODS


The effect of acute and delayed ACLR was randomized studied on 70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013. Patient-reported outcomes, objective IKDC, KOOS, and manual stability measurements were documented during the 24-month follow-up period.
RESULTS


The acute ACLR group did not result in increased stiffness and showed superior outcome regarding strength and how the patient felt their knee functioning at 24 months. In addition, the acute group was not inferior to the delayed group in any assessment. Regarding patient-related outcomes in KOOS, both groups showed significant improvements in all subscales, but no difference was found between the groups. Functional return (FR) rate was almost double compared to the Swedish knee ligament register and treatment failure (TF) rate was reduced by half, no significant difference between the groups. No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
CONCLUSION


Acute ACLR within 8 days of injury does not appear to adversely affect ROM or result in increased stiffness in the knee joint and was not inferior to the delayed group in any assessment when compared to delayed surgery.
LEVEL OF EVIDENCE


I.",2020,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","['70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013']",['acute ACL reconstruction (ACLR'],"['Functional return (FR) rate', 'Swedish knee ligament register and treatment failure (TF) rate', 'cyclops removal, re-injury of ACL or meniscus', 'objective IKDC, KOOS, and manual stability measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0162643'}, {'cui': 'C1578615', 'cui_str': 'Cyclops'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.053596,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05722-w']
849,32419304,"Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate.","OBJECTIVE


To evaluate the efficacy and safety of PF-06651600 (ritlecitinib), an irreversible inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, in comparison with placebo in patients with rheumatoid arthritis (RA).
METHODS


An 8-week, phase II, double-blind, parallel-group study was conducted. Seventy patients who were seropositive for anti-citrullinated protein antibodies and/or rheumatoid factor were randomized 3:2 to receive oral PF-06651600 (200 mg once daily) or placebo for 8 weeks. Eligible patients had an inadequate response to methotrexate, and the study design allowed up to 50% of patients to have previously received 1 tumor necrosis factor inhibitor that was inadequately effective and/or not tolerated. The primary end point was change from baseline in the Simplified Disease Activity Index (SDAI) score at week 8, assessed by Bayesian analysis using an informative prior distribution for placebo response.
RESULTS


Mean change from baseline in the SDAI score at week 8 was greater in the PF-06651600 group (-26.1 [95% credible interval -29.7, -22.4]) than in the placebo group (-16.8 [95% credible interval -20.9, -12.7]; P < 0.001). Most adverse events (AEs) were mild in severity, and no treatment-related serious AEs, severe AEs, or deaths were reported. The most common classes of AE were infections and infestations as well as skin and subcutaneous tissue disorders; there was 1 mild case of herpes simplex in the PF-06651600 group that was considered to be treatment related, which resolved within 3 days without study treatment discontinuation or antiviral therapy.
CONCLUSION


Treatment with the oral JAK3/TEC inhibitor PF-06651600 (200 mg once daily) was associated with significant improvements in RA disease activity and was generally well-tolerated in this small 8-week study.",2020,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","['patients with rheumatoid arthritis (RA', 'Seventy patients, seropositive for anticitrullinated protein antibodies and/or rheumatoid factor', 'Patients with Moderate to Severe Rheumatoid Arthritis']","['oral PF-06651600 (200\xa0mg once daily [QD]) or placebo', 'oral JAK3/TEC inhibitor, PF-06651600', 'methotrexate', 'PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor', 'PF-06651600 (ritlecitinib', 'Methotrexate', 'placebo']","['infections and infestations and skin and subcutaneous tissue disorders', 'Mean change from baseline SDAI score', 'Simple Disease Activity Index (SDAI) score', 'RA disease activity', 'serious or severe AEs, or deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4505882', 'cui_str': 'PF-06651600'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178298', 'cui_str': 'Disorder of skin and/or subcutaneous tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.272349,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Robinson', 'Affiliation': 'California Medical Research Associates, Northridge.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Damjanov', 'Affiliation': 'University of Belgrade School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Bojana', 'Initials': 'B', 'LastName': 'Stamenkovic', 'Affiliation': 'Institute for Treatment and Rehabilitation Niska Banja and Nis University School of Medicine, Nis, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Radunovic', 'Affiliation': 'University of Belgrade School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Cox', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Zorayr', 'Initials': 'Z', 'LastName': 'Manukyan', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Pfizer, Inc., New York, New York.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41316']
850,31821221,Feasibility and Acceptability of a Lifestyle Intervention For Individuals With Bipolar Disorder.,"Individuals with bipolar disorder are at greater risk for cardiovascular disease and are less likely to adhere to lifestyle interventions than the general population. To decrease cardiovascular risk and improve adherence to lifestyle interventions, we developed the Nutrition Exercise and Wellness Treatment (NEW Tx). NEW Tx is an 18-session, 20-week cognitive behavioral therapy-based treatment comprising 3 modules: Nutrition, Exercise, and Wellness. To evaluate the feasibility and acceptability of this intervention as well as predictors of treatment satisfaction and expectations, 38 adult outpatients with bipolar disorder were randomized to either NEW Tx or a waitlist control condition. There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition). In the NEW Tx condition, participants attended a mean of 66.7% of sessions and reported moderate to high satisfaction. There were no study-related adverse events. We also found that expectations, but not perceived credibility (or believability), of NEW Tx (as measured by the Credibility/Expectancy Questionnaire) at baseline predicted treatment satisfaction (as measured by the Care Satisfaction Questionnaire) posttreatment. Manic symptoms at baseline predicted treatment satisfaction, and marital status predicted one's expectations of lifestyle interventions. Data suggest that NEW Tx is a feasible and acceptable intervention for individuals with bipolar disorder and that further research is warranted to explore potential moderators of treatment expectations and credibility in this clinical population.",2019,"There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition).","['individuals with bipolar disorder', 'Individuals With Bipolar Disorder', 'Individuals with bipolar disorder', '38 adult outpatients with bipolar disorder']","['Lifestyle Intervention', 'NEW Tx or a waitlist control condition']","['Manic symptoms', 'perceived credibility (or believability), of NEW Tx (as measured by the Credibility/Expectancy Questionnaire', 'Feasibility and Acceptability', 'feasibility and acceptability', 'cardiovascular risk', 'dropout rates']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",38.0,0.0232546,"There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition).","[{'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': ""SYLVIA, ELLARD, NIERENBERG, DECKERSBACH: Massachusetts General Hospital and Harvard Medical School, Boston, MA JANOS, WALSH, DUFOUR, DAVIS: Massachusetts General Hospital, Boston, MA CHANG: Women's Treatment Program, McLean Hospital, Belmont, MA BERNSTEIN: Harvard University, Cambridge, MA.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Janos', 'Affiliation': ''}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Pegg', 'Affiliation': ''}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Dufour', 'Affiliation': ''}, {'ForeName': 'Weilynn C', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Bernstein', 'Affiliation': ''}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ellard', 'Affiliation': ''}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000426']
851,32063367,"Efficacy and safety of an abbreviated perioperative care bundle versus standard perioperative care in children undergoing elective bowel anastomoses: A randomized, noninferiority trial.","PURPOSE


The aim was to evaluate if an abbreviated perioperative care bundle (APCB) is noninferior to the standard care, in terms of efficacy and safety, in pediatric patients undergoing bowel anastomoses.
METHODS


A randomized, open, noninferiority trial with two parallel groups of equal size was carried out at the National Institute of Pediatrics in Mexico City, Mexico, from April 2016 to July 2018. The total number analyzed was 74 (37 per group). The APCB comprised same day admission, avoidance of mechanical bowel preparation, optimized antibiotic prophylaxis, and early feeding. Statistical analysis was done with Fisher's exact test or Chi 2 , and Student's T test.
RESULTS


No significant differences were found for demographic variables and type of disease, either for the safety (anastomotic leakage, p 0.753; organ/space surgical site infection, p 0.500) or for some efficacy outcomes (ileus or bowel obstruction, p 0.693). Other efficacy outcomes were better in the study group, with shorter median times for feeding tolerance (19 h vs. 92 h, p < 0.001), for first bowel movement (15 h vs. 36 h, p < 0.001), and for discharge (1 vs. 6 days, p < 0.001).
CONCLUSION


The abbreviated care bundle was proven to be as safe but more efficacious than the standard care.
LEVEL OF EVIDENCE


I - randomized controlled trial with adequate statistical power.",2020,"No significant differences were found for demographic variables and type of disease, either for the safety (anastomotic leakage, p 0.753; organ/space surgical site infection, p 0.500) or for some efficacy outcomes (ileus or bowel obstruction, p 0.693).","['two parallel groups of equal size was carried out at the National Institute of Pediatrics in Mexico City, Mexico, from April 2016 to July 2018', 'children undergoing elective bowel anastomoses', 'pediatric patients undergoing bowel anastomoses']","['abbreviated perioperative care bundle (APCB', 'abbreviated perioperative care bundle versus standard perioperative care']","['efficacy and safety', 'Efficacy and safety', 'demographic variables and type of disease, either for the safety (anastomotic leakage, p 0.753; organ/space surgical site infection', 'shorter median times for feeding tolerance', 'efficacy outcomes (ileus or bowel obstruction']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0150706', 'cui_str': 'Perioperative Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",,0.128248,"No significant differences were found for demographic variables and type of disease, either for the safety (anastomotic leakage, p 0.753; organ/space surgical site infection, p 0.500) or for some efficacy outcomes (ileus or bowel obstruction, p 0.693).","[{'ForeName': 'Karla A', 'Initials': 'KA', 'LastName': 'Santos-Jasso', 'Affiliation': 'Department of General Pediatric Surgery, Instituto Nacional de Pediatria, Av Insurgentes Sur 3700-C, Colonia Insurgentes Cuicuilco, Alcaldia Coyoacan, Mexico City, Mexico 04530. Electronic address: santosjasso@hotmail.com.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lezama-Del Valle', 'Affiliation': 'Department of General Pediatric Surgery, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. Electronic address: pablolezamadelvalle@gmail.com.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Arredondo-Garcia', 'Affiliation': 'Department of Clinical Research, Instituto Nacional de Pediatria, Mexico City, Mexico.'}, {'ForeName': 'Silvestre', 'Initials': 'S', 'LastName': 'García-De la Puente', 'Affiliation': 'Department of Clinical Research, Instituto Nacional de Pediatria, Mexico City, Mexico.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Department of Research, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.12.010']
852,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
853,31793630,Combination Therapy of Adalimumab With an Immunomodulator Is Not More Effective Than Adalimumab Monotherapy in Children With Crohn's Disease: A Post Hoc Analysis of the PAILOT Randomized Controlled Trial.,"BACKGROUND


The PAILOT trial was a randomized controlled trial aimed to evaluate proactive vs reactive therapeutic drug monitoring in children with Crohn's disease (CD) treated with adalimumab. Our aim in this post hoc analysis of the PAILOT trial was to assess the efficacy and safety of adalimumab combination treatment in comparison with monotherapy at week 72 after adalimumab induction.
METHODS


Participants were children 6-17 years old, biologic naïve, with moderate to severe CD, who responded to adalimumab induction at week 4. Patients receiving immunomodulators at baseline maintained a stable dose until week 24; patients could then discontinue immunomodulators. At each visit, patients were assessed for disease index, serum biomarkers, fecal calprotectin, adalimumab trough concentration, and anti-adalimumab antibodies.
RESULTS


Out of the 78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received combination therapy. During the study period, there was no significant difference in the rates of sustained corticosteroid-free clinical remission (25/34, 73%, vs 28/44, 63%; P = 0.35) or sustained composite outcome of clinical remission, C-reactive protein ≤0.5 mg/dL, and calprotectin ≤150 µg/g (10/34, 29%, vs 14/44, 32%; P = 0.77) between the combination group and the monotherapy group, respectively. Clinical and biological outcomes did not differ between the proactive and reactive subgroups within the combination and monotherapy groups. Adalimumab trough concentrations and immunogenicity were not significantly different between groups. The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
CONCLUSIONS


Combination therapy of adalimumab and an immunomodulator was not more effective than adalimumab monotherapy in children with CD (ClinicalTrials.gov No. NCT02256462).",2020,"The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
","['Participants were children 6-17 years old, biologic naïve, with moderate to severe CD, who responded to adalimumab induction at week 4', 'Children', ""With Crohn's Disease"", '78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received', ""children with Crohn's disease (CD) treated with""]","['Adalimumab Monotherapy', 'Adalimumab', 'combination therapy', 'adalimumab']","['rates of sustained corticosteroid-free clinical remission', 'rate of serious adverse events', 'efficacy and safety', 'disease index, serum biomarkers, fecal calprotectin, adalimumab trough concentration, and anti-adalimumab antibodies', 'Adalimumab trough concentrations and immunogenicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.244511,"The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
","[{'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Matar', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Shamir', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Broide', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Batia', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Guz-Mark', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Rinawi', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Chani', 'Initials': 'C', 'LastName': 'Topf-Olivestone', 'Affiliation': 'Pediatric Gastroenterology Unit, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': 'Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Saban Pediatric Medical Center, Soroka University Hospital and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shomron', 'Initials': 'S', 'LastName': 'Ben-Horin', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}]",Inflammatory bowel diseases,['10.1093/ibd/izz294']
854,26016859,"Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


To our knowledge, prior research has not examined the effects of magnesium supplementation on metabolic status and pregnancy outcomes in maternal-child dyads affected by gestational diabetes (GDM).
OBJECTIVE


This study was designed to assess the effects of magnesium supplementation on metabolic status and pregnancy outcomes in magnesium-deficient pregnant women with GDM.
DESIGN


A randomized, double-blind, placebo-controlled clinical trial was performed in 70 women with GDM. Patients were randomly assigned to receive either 250 mg magnesium oxide (n = 35) or a placebo (n = 35) for 6 wk. Fasting blood samples were taken at baseline and after a 6-wk intervention.
RESULTS


The change in serum magnesium concentration was greater in women consuming magnesium than in the placebo group (+0.06 ± 0.3 vs. -0.1 ± 0.3 mg/dL, P = 0.02). However, after controlling for baseline magnesium concentrations, the changes in serum magnesium concentrations were not significantly different between the groups. Changes in fasting plasma glucose (-9.7 ± 10.1 vs. +1.8 ± 8.1 mg/dL, P < 0.001), serum insulin concentration (-2.1 ± 6.5 vs. +5.7 ± 10.7 μIU/mL, P = 0.001), homeostasis model of assessment-estimated insulin resistance (-0.5 ± 1.3 vs. +1.4 ± 2.3, P < 0.001), homeostasis model of assessment-estimated β-cell function (-4.0 ± 28.7 vs. +22.0 ± 43.8, P = 0.006), and the quantitative insulin sensitivity check index (+0.004 ± 0.021 vs. -0.012 ± 0.015, P = 0.005) in supplemented women were significantly different from those in women in the placebo group. Changes in serum triglycerides (+2.1 ± 63.0 vs. +38.9 ± 37.5 mg/dL, P = 0.005), high sensitivity C-reactive protein (-432.8 ± 2521.0 vs. +783.2 ± 2470.1 ng/mL, P = 0.03), and plasma malondialdehyde concentrations (-0.5 ± 1.6 vs. +0.3 ± 1.2 μmol/L, P = 0.01) were significantly different between the supplemented women and placebo group. Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia (8.8% vs. 29.4%, P = 0.03) and newborn hospitalization (5.9% vs. 26.5%, P = 0.02).
CONCLUSION


Magnesium supplementation among women with GDM had beneficial effects on metabolic status and pregnancy outcomes. This trial was registered at www.irct.ir as IRCT201503055623N39.",2015,"Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia (8.8% vs. 29.4%, P = 0.03) and newborn hospitalization (5.9% vs. 26.5%, P = 0.02).
","['maternal-child dyads affected by gestational diabetes (GDM', '70 women with GDM', 'magnesium-deficient pregnant women with GDM', 'women with GDM', 'gestational diabetes']","['Magnesium supplementation', 'magnesium supplementation', 'placebo', '250 mg magnesium oxide']","['newborn hospitalization', 'Changes in serum triglycerides', 'fasting plasma glucose', 'quantitative insulin sensitivity check index', 'homeostasis model of assessment-estimated insulin resistance', 'serum magnesium concentrations', 'newborn hyperbilirubinemia', 'homeostasis model of assessment-estimated β-cell function', 'serum insulin concentration', 'Fasting blood samples', 'plasma malondialdehyde concentrations', 'serum magnesium concentration', 'high sensitivity C-reactive protein', 'metabolic status and pregnancy outcomes']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}]",70.0,0.635038,"Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia (8.8% vs. 29.4%, P = 0.03) and newborn hospitalization (5.9% vs. 26.5%, P = 0.02).
","[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran;'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran;'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidarzadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran;'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Benisi-Kohansal', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Surkan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; and.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran esmaillzadeh@hlth.mui.ac.ir.'}]",The American journal of clinical nutrition,['10.3945/ajcn.114.098616']
855,31144282,Communicating a Prognosis: a Randomized Trial of Survival Rate Language.,,2019,,[],[],[],[],[],[],,0.121896,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Silver', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Broomell', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Davis', 'Affiliation': 'Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA. tamark@pitt.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05056-w']
856,21777019,Homeostatic modulation of stimulation-dependent plasticity in human motor cortex.,"Since recently, it is possible, using noninvasive cortical stimulation, such as the protocol of paired associative stimulation (PAS), to induce the plastic changes in the motor cortex, in humans that mimic Hebb's model of learning. Application of TMS conjugated with peripheral electrical stimulation at strictly coherent temporal manner lead to convergence of inputs in the sensory-motor cortex, with the consequent synaptic potentiation or weakening, if applied repetitively. However, when optimal interstimulus interval (ISI) for induction of LTP-like effects is applied as a single pair, Motor evoked potential (MEP) amplitude inhibition is observed, the paradigm known as short-latency afferent inhibition (SLAI). Aiming to resolve this paradox, PAS protocols were applied, with 200 repetitions of TMS pulses paired with median nerve electrical stimulation, at ISI equal to individual latencies of evoked response of somatosensory cortex (N(20)) (PAS(LTP)), and at ISI of N(20) shortened for 5 msec (PAS(LTD)) - protocols that mimic LTP-like changes in the human motor cortex. MEP amplitudes before, during and after interventions were measured as an indicator based on output signals originating from the motor system. Post-intervention MEP amplitudes following the TMS protocols of PAS(LTP) and PAS(LTD) were facilitated and depressed, respectively, contrary to MEP amplitudes during intervention. During PAS(LTP) MEP amplitudes were significantly decreased in case of PAS(LTP), while in the case of PAS(LTD) an upward trend was observed. In conclusions, a possible explanation for the seemingly paradoxical effect of PAS can be found in the mechanism of homeostatic modulation of plasticity. Those findings indicate the existence of complex relationships in the development of plasticity induced by stimulation, depending on the level of the previous motor cortex excitability.",2011,"Post-intervention MEP amplitudes following the TMS protocols of PAS(LTP) and PAS(LTD) were facilitated and depressed, respectively, contrary to MEP amplitudes during intervention.",['human motor cortex'],"['TMS pulses paired with median nerve electrical stimulation, at ISI equal to individual latencies of evoked response of somatosensory cortex (N(20', 'TMS conjugated with peripheral electrical stimulation']",['MEP amplitudes'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",[],,0.0412248,"Post-intervention MEP amplitudes following the TMS protocols of PAS(LTP) and PAS(LTD) were facilitated and depressed, respectively, contrary to MEP amplitudes during intervention.","[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Ilić', 'Affiliation': 'Clinic of Rehabilitation Medicine, Clinical Center of Serbia, Belgrade, Serbia. tihoilic@gmail.com'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Milanović', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krstić', 'Affiliation': ''}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Bajec', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grajić', 'Affiliation': ''}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Ilić', 'Affiliation': ''}]",Physiological research,[]
857,32424568,Monitor-based exoscopic 3D4k neurosurgical interventions: a two-phase prospective-randomized clinical evaluation of a novel hybrid device.,"BACKGROUND


Promoting a disruptive innovation in microsurgery, exoscopes promise alleviation of physical strain and improved image quality through digital visualization during microneurosurgical interventions. This study investigates the impact of a novel 3D4k hybrid exoscope (i.e., combining digital and optical visualization) on surgical performance and team workflow in preclinical and clinical neurosurgical settings.
METHODS


A pre-clinical workshop setting has been developed to assess usability and implementability through skill-based scenarios (neurosurgical participants n = 12). An intraoperative exploration in head and spine surgery (n = 9) and a randomized clinical study comparing ocular and monitor mode in supratentorial brain tumor cases (n = 20) followed within 12 months. Setup, procedure, case characteristics, surgical performance, and user experience have been analyzed for both ocular group (OG) and monitor group (MG).
RESULTS


Brain tumor cases using frontal, frontoparietal, or temporal approaches have been identified as favorable use cases for introducing exoscopic neurosurgery. Mean monitor distance and angle were 180 cm and 10°. Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03). Hand-eye coordination required familiarization in MG. Preclinical data showed a positive correlation between lateral camera inclination and impact on hand-eye coordination (r s  = 0.756, P = .01). There was no significant added surgical time in MG. Image quality in current generation 3D4k monitors has been rated inferior to optic visualization yet awaits updates.
CONCLUSIONS


The hybrid exoscopic device can be integrated into established neurosurgical workflows. Currently, exoscopic interventions seem most suited for cranial tumor surgery in lesions that are not deep-seated. Ergonomics improve in monitor mode compared to conventional microsurgery.",2020,Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03).,"['supratentorial brain tumor cases (n\u2009=\u200920) followed within 12\xa0months', 'head and spine surgery (n\u2009=\u20099']","['novel 3D4k hybrid exoscope (i.e., combining digital and optical visualization', 'Monitor-based exoscopic 3D4k neurosurgical interventions']","['Mean monitor distance and angle', 'surgical time', 'lateral camera inclination and impact on hand-eye coordination']","[{'cui': 'C1522407', 'cui_str': 'Supratentorial brain'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0957368,Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03).,"[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Roethe', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. anna.roethe@charite.de.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Landgraf', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schröder', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misch', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Picht', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",Acta neurochirurgica,['10.1007/s00701-020-04361-2']
858,31343948,"""Beet"" the cold: beetroot juice supplementation improves peripheral blood flow, endothelial function, and anti-inflammatory status in individuals with Raynaud's phenomenon.","Raynaud's phenomenon (RP) is characterized by recurrent transient peripheral vasospasm and lower nitric oxide (NO) bioavailability in the cold. We investigated the effect of nitrate-rich beetroot juice (BJ) supplementation on  1 ) NO-mediated vasodilation,  2 ) cutaneous vascular conductance (CVC) and skin temperature (T sk ) following local cooling, and  3 ) systemic anti-inflammatory status. Following baseline testing, 23 individuals with RP attended four times, in a double-blind, randomized crossover design, following acute and chronic (14 days) BJ and nitrate-depleted beetroot juice (NDBJ) supplementation. Peripheral T sk  and CVC were measured during and after mild hand and foot cooling, and during transdermal delivery of acetylcholine and sodium nitroprusside. Markers of anti-inflammatory status were also measured. Plasma nitrite concentration ([nitrite]) was increased in the BJ conditions ( P  < 0.001). Compared with the baseline visit, thumb CVC was greater following chronic-BJ (Δ2.0 flux/mmHg,  P  = 0.02) and chronic-NDBJ (Δ1.45 flux/mmHg,  P  = 0.01) supplementation; however, no changes in T sk  were observed ( P  > 0.05). Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved, by both BJ and NDBJ supplementation ( P  < 0.05). Acute and chronic BJ and NDBJ supplementation improved anti-inflammatory status, endothelial function and blood pressure (BP). CVC following cooling increased post chronic-BJ and chronic-NDBJ supplementation, but no effect on T sk  was observed. The key findings are that beetroot supplementation improves thumb blood flow, improves endothelial function and anti-inflammatory status, and reduces BP in people with Raynaud's. NEW & NOTEWORTHY  This is the first study to examine the effect of dietary nitrate supplementation in individuals with Raynaud's phenomenon. The principal novel findings from this study were that both beetroot juice and nitrate-depleted beetroot juice  1 ) increased blood flow in the thumb following a cold challenge;  2 ) enhanced endothelium-dependent and -independent vasodilation in the forearm;  3 ) reduced systolic and diastolic blood pressure, and pan-endothelin concentration; and  4 ) improved inflammatory status in comparison to baseline.",2019,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[""individuals with Raynaud's phenomenon""]","['NDBJ supplementation', 'nitrate-depleted beetroot juice (NDBJ) supplementation', 'acetylcholine and sodium nitroprusside', 'nitrate-rich beetroot juice (BJ) supplementation']","['Plasma [interleukin-10', 'Peripheral T sk  and CVC', 'peripheral blood flow, endothelial function and anti-inflammatory status', 'nitric oxide (NO) bioavailability', 'chronic-NDBJ', 'pan endothelin and systolic and diastolic blood pressure (BP', 'anti-inflammatory status, endothelial function and BP', 'forearm endothelial function', 'Plasma [nitrite', 'T sk', 'i)  NO-mediated vasodilation,  ii)  cutaneous vascular conductance (CVC) and skin temperature (T sk ']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0034735', 'cui_str': 'Raynaud Phenomenon'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0079284', 'cui_str': 'Endothelium-Derived Vasoconstrictor Factors'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",23.0,0.1203,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[{'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Shepherd', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Bishop', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Young-Min', 'Affiliation': 'Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gilchrist', 'Affiliation': 'University of Exeter Medical School and NIHR Exeter Clinical Research Facility, Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mayes', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gorczynski', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Saynor', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Massey', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Clare M', 'Initials': 'CM', 'LastName': 'Eglin', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00292.2019']
859,32089006,Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment in the ODYSSEY phase 3 trials with alirocumab.,"AIMS


Guidelines recommend targeting non-high-density lipoprotein cholesterol to reduce cardiovascular risk. We assessed the impact of baseline triglycerides on non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n  = 4983).
METHODS


Trials were grouped into four pools based on alirocumab dose (75-150 mg every 2 weeks), control (placebo/ezetimibe) and statin use. Baseline triglyceride quintiles were built within each pool. Non-high-density lipoprotein cholesterol goal attainment (very high risk: <100 mg/dl; moderate/high risk: <130 mg/dl), low-density lipoprotein cholesterol goal attainment (very high risk: <70 mg/dl; moderate/high risk: <100 mg/dl) and changes from baseline in lipid parameters were assessed at Week 24 among baseline triglyceride quintiles.
RESULTS


Higher baseline triglycerides were associated with a worse cardiovascular risk profile. Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol increased with higher triglycerides, but the magnitude in non-high-density lipoprotein cholesterol was three- to four-fold higher compared with the increase in low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions from baseline with alirocumab were similar regardless of baseline triglycerides. A greater proportion of alirocumab-treated patients attained non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol goals compared with placebo or ezetimibe. Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests). A single standard deviation increase in baseline log(triglycerides) was significantly associated with lower odds ratios of attaining non-high-density lipoprotein cholesterol goals in the different pools and treatment (alirocumab/placebo/ezetimibe) groups, unlike low-density lipoprotein cholesterol goal attainment.
CONCLUSION


Individuals with increased triglycerides have higher non-high-density lipoprotein cholesterol levels and lower rates of non-high-density lipoprotein cholesterol goal attainment (unlike low-density lipoprotein cholesterol goal attainment). Alirocumab improves non-high-density lipoprotein cholesterol goal attainment in this population. These results highlight the impact of triglycerides on non-high-density lipoprotein cholesterol and the need for novel therapies targeting triglyceride-related pathways.",2020,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).",['non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n \u2009=\u20094983'],"['placebo/ezetimibe', 'placebo or ezetimibe', 'control (placebo/ezetimibe) and statin use', 'Alirocumab']","['Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment', 'Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol', 'density lipoprotein cholesterol', 'Baseline triglyceride quintiles', 'baseline log(triglycerides', 'Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment', 'non-high-density lipoprotein cholesterol goal attainment', 'low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions', 'cardiovascular risk profile', 'low-density lipoprotein cholesterol goal attainment']","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.416905,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).","[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Vallejo-Vaz', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'Li Ka Shing Knowledge Institute, University of Toronto, Canada.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Italy.'}, {'ForeName': 'Marja-Riitta', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': 'Cardiovascular Research Unit, University of Helsinki, Finland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, German.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mandel', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Samuel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., USA.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}]",European journal of preventive cardiology,['10.1177/2047487320905185']
860,25705286,The relationship between alanerv(®) consumption and erythrocytes' redox status in post-acute stroke patients undergoing rehabilitation.,"OBJECTIVES


Stroke is a pathological condition associated with a redox imbalance. Both the acute and the post-acute phases after a stroke are characterized by a pro-oxidant state, which could be corrected through antioxidant supplementation. The aim of the present study was to evaluate the effect of the ALAnerv(®) upon the redox status of erythrocytes.
MATERIAL AND METHODS


For this pilot study were enrolled 28 post-acute stroke patients. They were randomly divided into a control group [(-) ALA] and a study group [(+) ALA]. Patients were hospitalized for a period of two weeks. Blood samples were taken at the beginning and at the end of this period. Patients from (+) ALA group received the nutritional supplement ALAnerv(®). Catalase, SOD, GPx, GRed and GT activities were assessed on erythrocytes' lysates. Also, the total antioxidant capacity as well as the concentration of total thiols were evaluated.
OUTCOMES


During the study period only SOD (1393.48 ± 69.14 U/g Hb vs. 1514.06 ± 60.80) and GRed (4.47 ± 0.37 U/g Hb vs. 5.06 ± 0.24) significantly increased in (+) ALA group. Catalase (173.70 ± 14.62 k/g Hb vs. 123.41 ± 8.71) and GT (5.55 ± 0.26 U/g Hb vs. 4.95 ± 0.23) activities significantly decreased during the study period. Multiple regression indicated that only SOD, GT and GRed activities were influenced by the ALAnerv(®) consumption. There was no significant increase if the total thiols concentration.
CONCLUSIONS


ALAnerv(®) consumption could be associated with a correction of the erythrocytes' redox status. There is a need to investigate if administration of ALAnerv(®) over a longer time period could have a more significant influence on the erythrocytes' antioxidant system.",2014,"There was no significant increase if the total thiols concentration.
","['enrolled 28 post-acute stroke patients', 'post-acute stroke patients undergoing rehabilitation']","['ALAnerv(®) consumption', 'control group [(-) ALA', 'ALAnerv(®', 'nutritional supplement ALAnerv(®']","['concentration of total thiols', 'SOD, GT and GRed activities', 'total antioxidant capacity', ""alanerv(®) consumption and erythrocytes' redox status"", 'Catalase, SOD, GPx, GRed and GT activities', 'total thiols concentration']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038734', 'cui_str': 'Mercaptans'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}]",28.0,0.0487465,"There was no significant increase if the total thiols concentration.
","[{'ForeName': 'Bogdan Nicolae', 'Initials': 'BN', 'LastName': 'Manolescu', 'Affiliation': '""C.D. Nenitescu"" Department of Organic Chemistry, Faculty of Applied Chemistry and Science of Materials, Polytechnic University of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Cinteza', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Faculty of Medicine, ""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Berteanu', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Faculty of Medicine, ""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Carmina', 'Initials': 'C', 'LastName': 'Busu', 'Affiliation': 'Department of Functional Sciences, Faculty of Medicine, ""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Oprea', 'Affiliation': 'Department of Organic Chemistry, Biochemistry and Catalysis, Faculty of Chemistry, University of Bucharest, Romania.'}]",Maedica,[]
861,24132976,"Effects of vitamin D supplementation on glucose metabolism, lipid concentrations, inflammation, and oxidative stress in gestational diabetes: a double-blind randomized controlled clinical trial.","BACKGROUND


To our knowledge, there is no study that has examined the effects of vitamin D supplementation on metabolic status in gestational diabetes mellitus (GDM).
OBJECTIVE


This study was designed to assess the effects of vitamin D supplementation on metabolic profiles, high-sensitivity C-reactive protein, and biomarkers of oxidative stress in pregnant women with GDM.
DESIGN


This randomized, double-blind, placebo-controlled clinical trial was conducted in 54 women with GDM. Subjects were randomly assigned to receive either vitamin D supplements or placebo. Individuals in the vitamin D group (n = 27) received capsules containing 50,000 IU vitamin D₃ 2 times during the study (at baseline and at day 21 of the intervention) and those in the placebo group (n = 27) received 2 placebos at the same times. Fasting blood samples were collected at baseline and after 6 wk of the intervention to quantify relevant variables.
RESULTS


Cholecalciferol supplementation resulted in increased serum 25-hydroxyvitamin D concentrations compared with placebo (+18.5 ± 20.4 compared with +0.5 ± 6.1 ng/mL; P < 0.001). Furthermore, intake of vitamin D supplements led to a significant decrease in concentrations of fasting plasma glucose (-17.1 ± 14.8 compared with -0.9 ± 16.6 mg/dL; P < 0.001) and serum insulin (-3.08 ± 6.62 compared with +1.34 ± 6.51 μIU/mL; P = 0.01) and homeostasis model of assessment-insulin resistance (-1.28 ± 1.41 compared with +0.34 ± 1.79; P < 0.001) and a significant increase in the Quantitative Insulin Sensitivity Check Index (+0.03 ± 0.03 compared with -0.001 ± 0.02; P = 0.003) compared with placebo. A significant reduction in concentrations of total (-11.0 ± 23.5 compared with +9.5 ± 36.5 mg/dL; P = 0.01) and low-density lipoprotein (LDL) (-10.8 ± 22.4 compared with +10.4 ± 28.0 mg/dL; P = 0.003) cholesterol was also seen after vitamin D supplementation.
CONCLUSIONS


Vitamin D supplementation in pregnant women with GDM had beneficial effects on glycemia and total and LDL-cholesterol concentrations but did not affect inflammation and oxidative stress. This trial was registered at www.irct.ir as IRCT201305115623N7.",2013,"Furthermore, intake of vitamin D supplements led to a significant decrease in concentrations of fasting plasma glucose (-17.1 ± 14.8 compared with -0.9 ± 16.6 mg/dL; P < 0.001) and serum insulin (-3.08 ± 6.62 compared with +1.34 ± 6.51 μIU/mL; P = 0.01) and homeostasis model of assessment-insulin resistance (-1.28 ± 1.41 compared with +0.34 ± 1.79; P < 0.001) and a significant increase in the Quantitative Insulin Sensitivity Check Index (+0.03 ± 0.03 compared with -0.001 ± 0.02; P = 0.003) compared with placebo.","['pregnant women with GDM', '54 women with GDM', 'gestational diabetes', 'gestational diabetes mellitus (GDM']","['capsules containing 50,000 IU vitamin', 'placebo', 'vitamin D supplementation', 'vitamin D supplements', 'vitamin D supplements or placebo', 'placebos', 'vitamin D', 'Vitamin D supplementation', 'Cholecalciferol supplementation']","['serum 25-hydroxyvitamin D concentrations', 'Quantitative Insulin Sensitivity Check Index', 'glucose metabolism, lipid concentrations, inflammation, and oxidative stress', 'glycemia and total and LDL-cholesterol concentrations', 'metabolic status', 'homeostasis model of assessment-insulin resistance', 'concentrations of total', 'Fasting blood samples', 'metabolic profiles, high-sensitivity C-reactive protein, and biomarkers of oxidative stress', 'low-density lipoprotein (LDL', 'serum insulin', 'concentrations of fasting plasma glucose']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",54.0,0.675471,"Furthermore, intake of vitamin D supplements led to a significant decrease in concentrations of fasting plasma glucose (-17.1 ± 14.8 compared with -0.9 ± 16.6 mg/dL; P < 0.001) and serum insulin (-3.08 ± 6.62 compared with +1.34 ± 6.51 μIU/mL; P = 0.01) and homeostasis model of assessment-insulin resistance (-1.28 ± 1.41 compared with +0.34 ± 1.79; P < 0.001) and a significant increase in the Quantitative Insulin Sensitivity Check Index (+0.03 ± 0.03 compared with -0.001 ± 0.02; P = 0.003) compared with placebo.","[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases (ZA) and the Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran (TH and MS); the Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran (MK); and the Food Security Research Center, and the Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran (AE).'}, {'ForeName': 'Teibeh', 'Initials': 'T', 'LastName': 'Hashemi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': ''}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.3945/ajcn.113.072785']
862,25389284,"Cost-effectiveness of supervised exercise, stenting, and optimal medical care for claudication: results from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial.","BACKGROUND


Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost-effectiveness of these strategies is not well defined.
METHODS AND RESULTS


The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC. Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource-based methods and hospital billing data. Quality-adjusted life-years were estimated using the EQ-5D. Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost-effectiveness ratios were $24 070 per quality-adjusted life-year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost-effectiveness ratio for ST versus SE became more favorable.
CONCLUSIONS


Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit.
CLINICAL TRIAL REGISTRATION URL


www.clinicaltrials.gov, Unique identifier: NCT00132743.",2014,"Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20.","['The Claudication', 'patients with aortoiliac disease', 'patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC', 'Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months', 'patients with claudication']","['Exercise Versus Endoluminal Revascularization (CLEVER', 'supervised exercise, stenting, and optimal medical care', 'ST', 'Claudication: Exercise Versus Endoluminal Revascularization (CLEVER', 'supervised exercise (SE) and stenting (ST']","['quality of life', 'incremental cost-effectiveness ratio', 'functional status, symptoms, and quality of life', 'mean healthcare costs', 'incremental cost-effectiveness ratios']","[{'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729733', 'cui_str': 'Aortoiliac atherosclerosis (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0456326', 'cui_str': 'Aortoiliac (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1279682', 'cui_str': 'Clever (observable entity)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}]","[{'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.0828387,"Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Reynolds', 'Affiliation': 'Harvard Clinical Research Institute, Boston, MA (M.R.R., P.A.).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Apruzzese', 'Affiliation': 'Harvard Clinical Research Institute, Boston, MA (M.R.R., P.A.).'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Galper', 'Affiliation': ""Brigham & Women's Hospital, Boston, MA (B.Z.G.).""}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Murphy', 'Affiliation': 'Rhode Island Hospital, Providence, RI (T.P.M.).'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Hirsch', 'Affiliation': 'University of Minnesota, Minneapolis, MN (A.T.H.).'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Cutlip', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA (D.E.C.).'}, {'ForeName': 'Emile R', 'Initials': 'ER', 'LastName': 'Mohler', 'Affiliation': 'Division of Cardiovascular Disease, Section of Vascular Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA (E.R.M.).'}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Regensteiner', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO (J.G.R.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, MO (D.J.C.).""}]",Journal of the American Heart Association,['10.1161/JAHA.114.001233']
863,23121323,Strategies for multivessel revascularization in patients with diabetes.,"BACKGROUND


In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease.
METHODS


In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
RESULTS


From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03).
CONCLUSIONS


For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).",2012,"For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke.","['patients with diabetes and advanced coronary artery disease', 'patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG', 'patients with diabetes, coronary-artery bypass grafting (CABG', 'From 2005 through 2010, we enrolled 1900 patients at 140 international centers', ""patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease"", 'patients with diabetes and multivessel coronary artery disease', 'patients with diabetes']","['CABG', 'drug-eluting stents', 'percutaneous coronary intervention (PCI']","['low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin', 'rates of both myocardial infarction', 'Stroke', 'composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke', '5-year rates', 'rates of death and myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1900.0,0.195806,"For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY 10029, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Domanski', 'Affiliation': ''}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ''}, {'ForeName': 'Flora S', 'Initials': 'FS', 'LastName': 'Siami', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': ''}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ''}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ''}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Weinberger', 'Affiliation': ''}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': ''}, {'ForeName': 'J Eduardo', 'Initials': 'JE', 'LastName': 'Sousa', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rankin', 'Affiliation': ''}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Buse', 'Affiliation': ''}, {'ForeName': 'Whady', 'Initials': 'W', 'LastName': 'Hueb', 'Affiliation': ''}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Muratov', 'Affiliation': ''}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bansilal', 'Affiliation': ''}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bertrand', 'Affiliation': ''}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1211585']
864,31901284,Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial.,"INTRODUCTION


The aim of this 2-arm parallel trial was to compare the dentoskeletal effects of the expander with differential opening (EDO) and the Hyrax expander in the mixed dentition.
METHODS


Patients aged 7-11 years with maxillary dental arch constriction and Class I or Class II sagittal relationships were randomly allocated into 2 study groups. The experimental group comprised 22 patients (10 males, 12 females) with a mean age of 8.46 years treated with the EDO. The comparison group was composed of 24 patients (6 males, 18 females), mean age of 8.92 years treated with the conventional Hyrax expander. One complete turn per day for 6 days was performed for the posterior screw of the EDO and for the Hyrax expander. The anterior screw of the EDO was activated 1 complete turn per day for 10 days. The primary outcomes were the anterior opening of the midpalatal suture, changes on the interincisal diastema width, maxillary dental arch widths, arch perimeter, arch length, palatal depth, inclination of maxillary posterior teeth and on dental arch shape, and the amount of differential expansion in the anterior region compared with the posterior region of the maxillary dental arch. Computer-generated randomization was used. Allocation was concealed with sequentially, numbered, sealed, and opaque envelopes. Blinding was applicable for outcome assessment only. Occlusal radiographs of the maxilla were obtained at the end of the active expansion phase (T2). Intraoral photographs were obtained immediately pre-expansion (T1) and at T2. Digital dental models were obtained at T1 and 6 months after the active expansion period (T3). Intergroup comparisons of T1-T2 changes were performed using multiple linear regression analysis (P < 0.05). The independent variables were both treatment and the starting forms. Bonferroni correction for multiple tests was applied.
RESULTS


The experimental group showed a significantly greater opening of the anterior region of the midpalatal suture, a greater increase of the interincisal diastema width, and greater increases of the intercanine distance and inter-first deciduous molar distance than the Hyrax expander. The experimental group showed a significant differential expansion between the anterior and posterior regions, whereas the Hyrax group produced a similar expansion in the canine and molar regions. Serious harm was not observed.
CONCLUSIONS


The EDO was capable of promoting greater orthopedic and dental changes in the anterior region of the maxilla than the conventional Hyrax expander. Similarity between the 2 expanders was observed for changes in the posterior region width, arch perimeter, arch length, palatal depth, and posterior teeth inclination.",2020,"Similarity between the 2 expanders was observed for changes in the posterior region width, arch perimeter, arch length, palatal depth, and posterior teeth inclination.","['Patients aged 7-11\xa0years with maxillary dental arch constriction and Class I or Class II sagittal relationships', '22 patients (10 males, 12 females) with a mean age of 8.46\xa0years treated with the EDO', '24 patients (6 males, 18 females), mean age of 8.92\xa0years treated with the conventional Hyrax expander']","['Maxillary expander with differential opening vs Hyrax expander', 'expander with differential opening (EDO']","['Digital dental models', 'greater opening of the anterior region of the midpalatal suture', 'intercanine distance and inter-first deciduous molar distance', 'anterior screw of the EDO', 'posterior region width, arch perimeter, arch length, palatal depth, and posterior teeth inclination', 'interincisal diastema width', 'anterior opening of the midpalatal suture, changes on the interincisal diastema width, maxillary dental arch widths, arch perimeter, arch length, palatal depth, inclination of maxillary posterior teeth and on dental arch shape, and the amount of differential expansion in the anterior region compared with the posterior region of the maxillary dental arch']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0011381', 'cui_str': 'Dental Models'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0011998', 'cui_str': 'Diastema'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0429142', 'cui_str': 'Dental arch width (observable entity)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",,0.0381713,"Similarity between the 2 expanders was observed for changes in the posterior region width, arch perimeter, arch length, palatal depth, and posterior teeth inclination.","[{'ForeName': 'Arthur César de Medeiros', 'Initials': 'ACM', 'LastName': 'Alves', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil. Electronic address: arthurcesar_88@hotmail.com.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Janson', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Mcnamara', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry, School of Dentistry, School of Medicine, and Center for Human Growth and Development, University of Michigan, Ann Arbor, Mich; Private practice, Ann Arbor, Mich.'}, {'ForeName': 'José Roberto Pereira', 'Initials': 'JRP', 'LastName': 'Lauris', 'Affiliation': 'Department of Public Health, Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Daniela Gamba', 'Initials': 'DG', 'LastName': 'Garib', 'Affiliation': 'Department of Orthodontics, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, São Paulo, Brazil.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.010']
865,32281393,Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.,"BACKGROUND


Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system.
METHODS


This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets.
RESULTS


Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41];  P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07];  P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage.
CONCLUSIONS


This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.",2020,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,['978±$29\u2009431 for Medicare Advantage'],"['Registration: URL', 'Cardiac Implantable Electronic Device Infection', 'cardiac implantable electronic device (CIED) infection']","['mortality, quality of life, healthcare utilization, and cost', 'Mean costs', 'Payer costs', 'major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs', 'Quality of life', 'cause mortality']","[{'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}]",,0.150794,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,"[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy (G.B.).'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Section of Electrophysiology, Valley Health System, Ridgewood, NJ (S.M.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle (J.E.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'The Sahlgrenska Academy, University of Göteborg, Sweden (C.K.).'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, NC (G.R.C.).'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Love', 'Affiliation': 'Maine Medical Partners, Maine Medical Center, Portland (J.C.L.).'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'Department of Internal Medicine, Ohio State University, Columbus (R.A.).'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Faerestrand', 'Affiliation': 'Department of Heart Disease, University of Bergen and Haukeland University Hospital, Norway (S.F.).'}, {'ForeName': 'Sherman S', 'Initials': 'SS', 'LastName': 'Wiggins', 'Affiliation': 'ARK-LA-TEX Cardiology, Christus Highland Hospital, Shreveport, LA (S.S.W.).'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, ON, Canada (J.S.H.).'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008280']
866,23884390,"Vitamin D supplementation affects serum high-sensitivity C-reactive protein, insulin resistance, and biomarkers of oxidative stress in pregnant women.","Unfavorable metabolic profiles and oxidative stress in pregnancy are associated with several complications. This study was conducted to determine the effects of vitamin D supplementation on serum concentrations of high-sensitivity C-reactive protein (hs-CRP), metabolic profiles, and biomarkers of oxidative stress in healthy pregnant women. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 pregnant women aged 18-40 y old at 25 wk of gestation. Participants were randomly assigned to receive either 400 IU/d cholecalciferol supplements (n = 24) or placebo (n = 24) for 9 wk. Fasting blood samples were taken at study baseline and after 9 wk of intervention to quantify serum concentrations of hs-CRP, lipid concentrations, insulin, and biomarkers of oxidative stress. After 9 wk of intervention, the increases in serum 25-hydroxyvitamin D and calcium concentrations were greater in the vitamin D group (+3.7 μg/L and +0.20 mg/dL, respectively) than in the placebo group (-1.2 μg/L and -0.12 mg/dL, respectively; P < 0.001 for both). Vitamin D supplementation resulted in a significant decrease in serum hs-CRP (vitamin D vs. placebo groups: -1.41 vs. +1.50 μg/mL; P-interaction = 0.01) and insulin concentrations (vitamin D vs. placebo groups: -1.0 vs. +2.6 μIU/mL; P-interaction = 0.04) and a significant increase in the Quantitative Insulin Sensitivity Check Index score (vitamin D vs. placebo groups: +0.02 vs. -0.02; P-interaction = 0.006), plasma total antioxidant capacity (vitamin D vs. placebo groups: +152 vs. -20 mmol/L; P-interaction = 0.002), and total glutathione concentrations (vitamin D vs. placebo groups: +205 vs. -32 μmol/L; P-interaction = 0.02) compared with placebo. Intake of vitamin D supplements led to a significant decrease in fasting plasma glucose (vitamin D vs. placebo groups: -0.65 vs. -0.12 mmol/L; P-interaction = 0.01), systolic blood pressure (vitamin D vs. placebo groups: -0.2 vs. +5.5 mm Hg; P-interaction = 0.01), and diastolic blood pressure (vitamin D vs. placebo groups: -0.4 vs. +3.1 mm Hg; P-interaction = 0.01) compared with placebo. In conclusion, vitamin D supplementation for 9 wk among pregnant women has beneficial effects on metabolic status.",2013,"Vitamin D supplementation resulted in a significant decrease in serum hs-CRP (vitamin D vs. placebo groups: -1.41 vs. +1.50 μg/mL; P-interaction = 0.01) and insulin concentrations (vitamin D vs. placebo groups: -1.0 vs. +2.6 μIU/mL; P-interaction = 0.04) and a significant increase in the Quantitative Insulin Sensitivity Check Index score (vitamin D vs. placebo groups: +0.02 vs. -0.02; P-interaction = 0.006), plasma total antioxidant capacity (vitamin D vs. placebo groups: +152 vs. -20 mmol/L; P-interaction = 0.002), and total glutathione concentrations (vitamin D vs. placebo groups: +205 vs. -32 μmol/L; P-interaction = 0.02) compared with placebo.","['healthy pregnant women', 'pregnant women', '48 pregnant women aged 18-40 y old at 25 wk of gestation']","['placebo', 'vitamin D supplementation', 'vitamin D supplements', '400 IU/d cholecalciferol supplements', 'Vitamin D supplementation']","['Quantitative Insulin Sensitivity Check Index score', 'Unfavorable metabolic profiles and oxidative stress', 'serum high-sensitivity C-reactive protein, insulin resistance, and biomarkers of oxidative stress', 'serum hs-CRP', 'total glutathione concentrations', 'fasting plasma glucose', 'systolic blood pressure', 'serum 25-hydroxyvitamin D and calcium concentrations', 'Fasting blood samples', 'serum concentrations of high-sensitivity C-reactive protein (hs-CRP), metabolic profiles, and biomarkers of oxidative stress', 'plasma total antioxidant capacity', 'diastolic blood pressure', 'serum concentrations of hs-CRP, lipid concentrations, insulin, and biomarkers of oxidative stress', 'insulin concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",48.0,0.673689,"Vitamin D supplementation resulted in a significant decrease in serum hs-CRP (vitamin D vs. placebo groups: -1.41 vs. +1.50 μg/mL; P-interaction = 0.01) and insulin concentrations (vitamin D vs. placebo groups: -1.0 vs. +2.6 μIU/mL; P-interaction = 0.04) and a significant increase in the Quantitative Insulin Sensitivity Check Index score (vitamin D vs. placebo groups: +0.02 vs. -0.02; P-interaction = 0.006), plasma total antioxidant capacity (vitamin D vs. placebo groups: +152 vs. -20 mmol/L; P-interaction = 0.002), and total glutathione concentrations (vitamin D vs. placebo groups: +205 vs. -32 μmol/L; P-interaction = 0.02) compared with placebo.","[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': ''}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Tabassi', 'Affiliation': ''}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shakeri', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The Journal of nutrition,['10.3945/jn.113.177550']
867,31365099,Genetic Variation of the Vitamin D Binding Protein Affects Vitamin D Status and Response to Supplementation in Infants.,"CONTEXT


Single nucleotide polymorphisms (SNPs) of the vitamin D binding protein encoding the GC (group component) gene affect 25-hydroxyvitamin D (25OHD) concentrations, but their influence on vitamin D status and response to vitamin D supplementation in infants is unknown.
OBJECTIVE


To study GC genotype-related differences in 25OHD concentrations and the response to supplementation during a vitamin D intervention study in infants.
DESIGN


In this randomized controlled trial, healthy term infants received vitamin D3 (10 or 30 μg/d) from 2 weeks to 24 months of age. GC SNPs rs2282679, rs4588, rs7041, and rs1155563 were genotyped. rs4588/7041 diplotype and haplotypes of rs2282679, rs4588, and rs7041 (Haplo3SNP) and of all four SNPs (Haplo4SNP) were determined.
MAIN OUTCOME MEASURES


25OHD measured in cord blood at birth and at 12 and 24 months during intervention.
RESULTS


A total of 913 infants were included. Minor allele homozygosity of all studied GC SNPs, their combined haplotypes, and rs4588/rs7041 diplotype 2/2 were associated with lower 25OHD concentrations at all time points in one or both intervention groups [analysis of covariance (ANCOVA) P < 0.043], with the exception of rs7041, which did not affect 25OHD at birth. In the high-dose supplementation group receiving 30 μg/d vitamin D3, but not in those receiving 10 µg/d, genotype of rs2282679, rs4588, and rs7041; diplotype; and Haplo3SNP significantly affected intervention response (repeated measurement ANCOVA Pinteraction < 0.019). Minor allele homozygotes had lower 25OHD concentrations and smaller increases in 25OHD throughout the intervention.
CONCLUSIONS


In infants, vitamin D binding protein genotype affects 25OHD concentration and efficiency of high-dose vitamin D3 supplementation.",2019,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","['Altogether 913 infants were included', 'Infants', 'healthy term infants received 10 or 30 μg vitamin D3/day from 2 weeks to 24 months of age', 'infants']",['vitamin D supplementation'],"['25OHD measured in cord blood at birth', '25OHD concentrations', '25-hydroxyvitamin D (25OHD) concentrations']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",913.0,0.144209,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Koljonen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Helve', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Hytinantti', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Viljakainen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Pekkinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00630']
868,32423038,A Longitudinal Study of a Multicomponent Exercise Intervention with Remote Guidance among Breast Cancer Patients.,"Purpose : Breast cancer patients in treatment suffer from long-term side effects that seriously influence their physical and mental health. The aim of this study was to examine effectiveness of a 12-week multicomponent exercise (ME) with remote guidance intervention on health-related outcomes after one year among breast cancer patients.  Methods : In phases I-III, 60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed chemotherapy/postoperative radiotherapy within the previous four months to two years were randomly assigned to 1) multicomponent exercise with remote guidance (ME) and 2) usual care (UC). Eligible participants were approached to assess cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers after one year.  Results : The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  Conclusion : The ME group observed significant differences from the UC group in QOL, muscle strength, cardiopulmonary endurance, and PA participation. These findings suggested that the multicomponent exercise intervention with remote guidance produced long-term health benefits for breast cancer patients.",2020,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","['breast cancer patients', 'Breast Cancer Patients', '60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed']","['multicomponent exercise (ME) with remote guidance intervention', 'multicomponent exercise intervention', 'Multicomponent Exercise Intervention', 'chemotherapy', 'multicomponent exercise with remote guidance (ME) and 2) usual care (UC', 'postoperative radiotherapy']","['higher vitality-related QOL', 'leg strength and endurance', 'lower physical activity (PA) hindrance', 'mental health-related QOL', 'QOL, muscle strength, cardiopulmonary endurance, and PA participation', 'strength and endurance of upper extremities', 'cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0333744,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","[{'ForeName': 'Xiaosheng', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Xiangren', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'College of Physical Education, Shandong Normal University, Jinan 250014, China.'}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'McDonough', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Yi', 'Affiliation': 'Department of Kinesiology, College of Health Science University of Wisconsin, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Science and Technology, Shandong Institute of Commerce and Technology, Jinan 250103, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17103425']
869,32423126,Effects of Combined Resistance and Power Training on Cognitive Function in Older Women: A Randomized Controlled Trial.,"The present study compared the effects of traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT) on cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels in non-demented, well-functioning, community-dwelling older women. Forty-five older women were randomized into one of three experimental groups: TRT, PTRT, and control group (CG). Cognitive tests explored global cognitive function, short-term memory, and dual-task performance. Serum BDNF levels were assessed at baseline and after the intervention. Exercise sessions were performed twice a week over 22 weeks. In TRT, exercise sessions were based on three sets of 8-10 repetitions at ""difficult"" intensity. In PTRT, the first session was based on PT (three sets of 8-10 repetitions at ""moderate"" intensity), while the second session was similar to the TRT. Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT. Serum BDNF concentrations were not altered by any training protocol. In conclusion, the two RT programs tested in the present trial improved global cognitive function, short-term memory and dual task performance in non-demented, well-functioning, community-dwelling older women. In addition, our findings suggest that mechanisms other than BDNF may be associated with such improvements.",2020,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","['Forty-five older women', 'Older Women', 'non-demented, well-functioning, community-dwelling older women']","['traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT', 'TRT, PTRT, and control group (CG', 'Combined Resistance and Power Training']","['cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels', 'global cognitive function, short-term memory, and dual-task performance', 'Serum BDNF concentrations', 'global cognitive function, short-term memory and dual task performance', 'Serum BDNF levels', 'Cognitive Function', 'overall cognitive function, short-term memory, and dual-task performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",45.0,0.0217528,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","[{'ForeName': 'Hélio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Ivan de Oliveira', 'Initials': 'IO', 'LastName': 'Gonçalves', 'Affiliation': 'Center of Health Sciences, University of Mogi das Cruzes, Mogi das Cruzes 08780-911, Brazil.'}, {'ForeName': 'Ricardo Aurélio Carvalho', 'Initials': 'RAC', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Priscila Yukari Sewo', 'Initials': 'PYS', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lusa Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, RS 90040-060, Brazil.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Picca', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), Navarra Institute for Health Research (IdiSNA), 31008 Pamplona, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Fondazione Policlinico Universitario ""Agostino Gemelli"" IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Marco Carlos', 'Initials': 'MC', 'LastName': 'Uchida', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17103435']
870,32423151,Effects of Different Ankle Supports on the Single-Leg Lateral Drop Landing Following Muscle Fatigue in Athletes with Functional Ankle Instability.,"BACKGROUND


Ankle support has been utilized for athletes with functional ankle instability (FAI), however, its effect on the landing performance during muscle fatigue is not well understood. This study aimed to examine the effects of ankle supports (ankle brace vs. Kinesio tape) on athletes with FAI following fatigued single-leg landing.
METHODS


Thirty-three young FAI athletes (CAIT scores < 24) were randomly allocated to control (Cn), ankle brace (AB) and Kinesio tape (KT) groups. All athletes performed single-leg lateral drop landings following ankle fatigue protocol. The fatigue-induced changes in kinetic parameters were measured among three groups.
RESULTS


A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups. Significant decrease in both COP medial-lateral (ML) and anterior-posterior (AP) ranges were also found in the KT group (median = -0.15% foot width (FW) & median = -0.28% foot length (FL)) than those of the Cn group (median = 0.67% FW& median = 0.88% FL).
CONCLUSIONS


Ankle braces might hamper the ability to absorb the impact force during landing. On the other hand, Kinesio tape might be beneficial for the postural control during landing.",2020,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"['Athletes with Functional Ankle Instability', 'athletes with FAI following fatigued single-leg landing', 'Thirty-three young FAI athletes (CAIT scores < 24', 'athletes with functional ankle instability (FAI']","['Single-Leg Lateral Drop Landing', 'ankle supports (ankle brace vs. Kinesio tape', 'control (Cn), ankle brace (AB) and Kinesio tape (KT']","['peak vertical ground reaction force (vGRF', 'COP medial-lateral (ML) and anterior-posterior (AP) ranges']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",33.0,0.0268298,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"[{'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, Tzu Hui Institute of Technology, Pingtung 926001, Taiwan.'}, {'ForeName': 'Shing-Jye', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Department of Product Design, College of Design, Tainan University of Technology, Tainan 71002, Taiwan.'}, {'ForeName': 'Wan-Chin', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103438']
871,32421841,"An open-label, randomized, single-dose, two-period, two-treatment crossover bioavailability study comparing 5 mg/0.5 mL of intramuscular naloxone hydrochloride to 2 mg/0.4 mL intramuscular naloxone hydrochloride autoinjector in healthy subjects.","Naloxone is an opioid antagonist used for the acute treatment of opioid overdoses. There has been a dramatic increase of deaths due to synthetic opioids such as fentanyl, some requiring multiple doses of naloxone for reversal of opioid tox-icity. Fentanyl appears to differ from other opiates as having a very rapid onset and transport in and out of the central nervous system (CNS). Fentanyl is therefore widely distributed in the CNS. Furthermore, a high range of systemic levels of fentanyl have been observed in overdose victims. Taken together, we believe it is very likely that higher doses of naloxone are needed to combat this new era of overdoses. We examined the bioavailability of an investigational 5 mg intramuscular naloxone in a prefilled syringe (PFS) compared to 2 mg intramuscular naloxone in an autoinjector (AI) at the current approved dose in a crossover design which included 14 healthy subjects. Overall, both doses were well tol-erated with no adverse events noted during the trial. The pharmacokinetic results showed that a higher dose of intra-muscular naloxone hydrochloride increases C max , AUC, and t 1/2;  however, T max  was similar for both treatments. Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent (CI: 255.6 percent, 292.4 percent), and t 1/2  of 110.5 percent (CI: 95.5, 127.9). These results are consistent with the study rationale that indicated higher doses of intramuscular naloxone hy-drochloride would result in higher C max  and AUCs. These PK characteristics may be desirable for reversing opioid toxicity caused by the higher, more potent synthetic opioids.",2020,"Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent","['14 healthy subjects', 'healthy subjects']","['naloxone hydrochloride autoinjector', 'intramuscular naloxone hydrochloride', 'Fentanyl', 'naloxone hydrochloride', 'naloxone', 'Naloxone']","['opioid toxicity', 'C max , AUC, and t 1/2;  however, T max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0700549', 'cui_str': 'Naloxone hydrochloride'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0412850', 'cui_str': 'Poisoning by opiate analgesic drug'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0580272', 'cui_str': '1/2'}]",14.0,0.0445083,"Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent","[{'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Moss', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Carleton', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Lollo', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Carlo', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}]",Journal of opioid management,['10.5055/jom.2020.0569']
872,30946523,"Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial.","OBJECTIVES


To report the long-term oncological outcomes of a randomised trial comparing androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone in patients with locally advanced prostate cancer.
PATIENTS AND METHODS


In this multicentre phase III trial, patients were randomly assigned to ADT alone or ADT+EBRT. Leuprorelin 11.25 mg was administered for 3 years. The whole pelvis was treated at a dose of 46 Gy and the prostate with a boost from 20 to 28 Gy. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), disease-specific survival (DSS), locoregional PFS (LRPFS), metastasis-free survival (MFS), biochemical PFS (BPFS), and tolerance.
RESULTS


With a median follow-up of 7.3 years, 263 patients were included. The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% vs 7%; hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.17-0.39; P < 0.001); in patients with a baseline PSA level ≥50 ng/mL (HR 0.10, 95% CI 0.05-0.20; P < 0.001) and in patients with a baseline PSA level <50 ng/mL (HR 0.28, 95% CI 0.19-0.40; P < 0.001). The risk of death from prostate cancer was significantly reduced in the ADT+EBRT arm (sub-HR [SHR] 0.48, 95% CI 0.25-0.91; P = 0.02). The 8-year OS rate was 57% in the ADT arm and 65% in the ADT+EBRT arm (no significant difference). LRPFS was significantly in favour of the ADT+EBRT arm (SHR 0.61, 95% CI 0.42-0.89; P = 0.01). MFS was comparable between both arms (P = 0.88). Analysis of toxicities revealed acute lower tolerance in the ADT+EBRT arm, with a gradual decrease in intensity from 6 months after the end of EBRT.
CONCLUSIONS


These long-term results confirm the oncological benefit of combining EBRT with ADT in the treatment of locally advanced prostate cancer.",2020,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","['locally advanced prostate cancer', 'locally-advanced prostate cancer', 'With a median follow-up of 7.3 years, 263 patients were included', 'patients treated with locally advanced prostate cancer']","['Leuprorelin', 'Long-term androgen deprivation, with or without radiotherapy', 'ADT alone or ADT+EBRT', 'EBRT with ADT', 'androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone']","['progression-free survival (PFS', 'overall survival (OS), disease-specific survival (DSS), locoregional progression free survival (LPFS), metastasis-free survival (MFS), biochemical progression free survival (BPFS) and tolerance', 'MFS', '8-year PFS rate', '8-year OS rate', 'risk of death from prostate cancer', 'LPFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",263.0,0.383482,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mottet', 'Affiliation': 'Department of Urology, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}]",BJU international,['10.1111/bju.14768']
873,32424502,Is there an association between perceived social support and cardiovascular health behaviours in people with severe mental illnesses?,"PURPOSE


People with severe mental illnesses (SMI) have an increased risk of cardiovascular disease (CVD). Research in the general population suggests that social support may protect against increased CVD morbidity and mortality; however, this may not apply to those with SMI. We aimed to explore the association between perceived social support and attendance at primary care nurse CVD risk reduction clinic appointments and CVD risk-reducing behaviours in an SMI population with elevated CVD risk factors.
METHODS


We used longitudinal and cross-sectional data from a randomised controlled trial on 326 adults with SMI recruited via 76 general practices in England. Multilevel regression analysis estimated the effect of perceived social support on attendance at CVD risk reduction clinic appointments over 6 months, and adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment.
RESULTS


Perceived social support predicted greater appointment attendance in unadjusted (IRR = 1.005; 1.000-1.010; p = 0.05) but not adjusted analysis (IRR = 1.003; 0.998-1.009; p = 0.25). Perceived social support was associated with greater adherence to medication; for each 1% increase in social support, there was a 4.2% increase in medication adherence (OR = 1.042; 1.015-1.070; p = 0.002). No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.",2020,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","['SMI population with elevated CVD risk factors', '326 adults with SMI recruited via 76 general practices in England', 'People with severe mental illnesses (SMI', 'people with severe mental illnesses']",[],"['CVD morbidity and mortality', 'appointment attendance', 'adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment', 'social support and greater physical activity, lower sedentary behaviour, healthier diet', 'risk of cardiovascular disease (CVD', 'social support', 'medication adherence']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",326.0,0.0483254,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Burton', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01879-9']
874,32427325,"Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care.","Importance


Lack of pediatric advance care planning has been associated with poor communication, increased hospitalization, poor quality of life, and legal actions. Clinicians presume that families understand adolescents' treatment preferences for end-of-life care.
Objective


To examine patient-reported end-of-life values and needs of adolescents with cancer and congruence with their families' understanding of these needs.
Design, Setting, and Participants


This cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals. Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning. Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis. Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older. Data analysis was performed from April 2019 to November 2019.
Exposure


Session 1 of the 3-session Family Centered Pediatric Advance Care Planning for Teens With Cancer intervention.
Main Outcomes and Measures


The main outcome was congruence between adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care. Prevalence-adjusted and bias-adjusted κ (PABAK) values were used to measure congruence on the Lyon Advance Care Planning Survey-Revised (Patient and Surrogate versions).
Results


A total of 80 adolescent-family dyads (160 participants) were randomized to the intervention group in the original trial. Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years. Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years. Family members' understanding of their adolescent's beliefs about the best time bring up end-of-life decisions was poor: 86% of adolescents wanted early timing (before getting sick, while healthy, when first diagnosed, when first sick from a life-threatening illness, or all of the above), but only 39% of families knew this (PABAK, 0.18). Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but poor for dying a natural death (PABAK, 0.18) and being off machines that extend life, if dying (PABAK, 0).
Conclusions and Relevance


Many families had a poor understanding of their adolescent's values regarding their own end-of-life care, such as when to initiate end-of-life conversations and preference for being off machines that extend life. Pediatric advance care planning could minimize these misunderstandings with the potential for a substantial impact on quality of care.",2020,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","['Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older', 'Teens With Cancer intervention', 'Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years', 'Participants\n\n\nThis cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals', 'adolescents with cancer and congruence with their families', 'Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning', 'Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years', 'Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis', '80 adolescent-family dyads (160 participants']",['3-session Family Centered Pediatric Advance Care Planning'],"['hospitalization, poor quality of life, and legal actions', 'Prevalence-adjusted and bias-adjusted κ (PABAK) values', ""adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}]",80.0,0.0323796,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': 'Division of Quality of Life and Palliative Care, St Jude Research Hospital, Memphis, Tennessee.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Needle', 'Affiliation': 'Center for Bioethics, Department of Pediatrics, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5424']
875,31540903,"Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial.","OBJECTIVE


To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).
RESEARCH DESIGN AND METHODS


Patients with T2D ( n  = 84) (HbA 1c  6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.
RESULTS


EMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2;  P  = 0.02) and relative change in LFC of -22% (-36, -7;  P  = 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42];  P  < 0.001) and high-molecular-weight adiponectin (36% [16, 60];  P  < 0.001) levels from 0 to 24 weeks.
CONCLUSIONS


EMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D.",2020,"Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4 kg];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed.","['Well-Controlled Type 2 Diabetes', 'Patients with T2D ( n  = 84) (HbA 1c  6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months', 'patients with T2D with excellent glycemic control and short known disease duration']","['Placebo', 'EMPA', 'EMPA (placebo', 'EMPA or placebo', 'sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA', 'Empagliflozin']","['change in LFC', 'insulin sensitivity and liver function', 'uric acid', 'hepatic fat', 'high-molecular-weight adiponectin', 'circulating uric acid and raises adiponectin levels', 'Tissue-specific insulin sensitivity', 'liver fat content (LFC', 'tissue-specific insulin sensitivity', 'Liver Fat Content', 'Weight loss']","[{'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin (substance)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.629387,"Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4 kg];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed.","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Straßburger', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Hisayuki', 'Initials': 'H', 'LastName': 'Katsuyama', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kabisch', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Henkel', 'Affiliation': 'Clinical Study Center of Metabolic Vascular Medicine, GWT-TUD GmbH, Dresden, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kopf', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Lagerpusch', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Kupriyanova', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Markgraf', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'van Gemert', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Knebel', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Wolkersdorfer', 'Affiliation': 'Landesapotheke Salzburg, Salzburg, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kuss', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Paul Langerhans Institute Dresden, Helmholtz Center Munich at University Hospital MKIII, and Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kasperk', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Stefan', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pfeiffer', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany michael.roden@ddz.de.'}]",Diabetes care,['10.2337/dc19-0641']
876,21777020,Startle stimuli exert opposite effects on human cortical and spinal motor system excitability in leg muscles.,"Increased excitability of the spinal motor system has been observed after loud and unexpected acoustic stimuli (AS) preceding H-reflexes. The paradigm has been proposed as an electrophysiological marker of reticulospinal tract activity in humans. The brainstem reticular formation also maintains dense anatomical interconnections with the cortical motor system. When a startling AS is delivered, prior to transcranial magnetic stimulation (TMS), the AS produces a suppression of motor evoked potential (MEP) amplitude in hand and arm muscles of healthy subjects. Here we analyzed the conditioning effect of a startling AS on MEP amplitude evoked by TMS to the primary motor leg area. Ten healthy volunteers participated in two experiments that used a conditioning-test paradigm. In the first experiment, a startling AS preceded a suprathreshold transcranial test stimulus. The interstimulus interval (ISI) varied between 20 to 160 ms. When given alone, the test stimulus evoked a MEP amplitude of approximately 0.5 mV in the slightly preinervated soleus muscle (SOL). In the second experiment, the startling AS was used to condition the size of the H-reflex in SOL muscle. Mean MEP amplitude was calculated for each ISI. The conditioning AS suppressed MEP amplitude at ISIs of 30-80 ms. By contrast, H-reflex amplitude was augmented at ISIs of 100-200 ms. In conclusions, acoustic stimulation exerts opposite and ISI-specific effects on the amplitude of MEPs and H-reflex in the SOL muscle, indicating different mechanism of auditory-to-motor interactions at cortical and spinal level of motor system.",2011,"In conclusions, acoustic stimulation exerts opposite and ISI-specific effects on the amplitude of MEPs and H-reflex in the SOL muscle, indicating different mechanism of auditory-to-motor interactions at cortical and spinal level of motor system.","['Ten healthy volunteers', 'healthy subjects', 'leg muscles']",['transcranial magnetic stimulation (TMS'],"['H-reflex amplitude', 'interstimulus interval (ISI', 'Mean MEP amplitude', 'MEP amplitude']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",10.0,0.0185953,"In conclusions, acoustic stimulation exerts opposite and ISI-specific effects on the amplitude of MEPs and H-reflex in the SOL muscle, indicating different mechanism of auditory-to-motor interactions at cortical and spinal level of motor system.","[{'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Ilic', 'Affiliation': 'Clinic of Neurology, Christian-Albrechts-University of Kiel, Germany. tihoilic@gmail.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Holler', 'Affiliation': ''}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Ilic', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deuschl', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Volkmann', 'Affiliation': ''}]",Physiological research,[]
877,21777032,Biomarkers of oxidative stress and endothelial dysfunction after tourniquet release in children.,"Pneumatic tourniquets are widely used in pediatric extremity surgery to provide a bloodless field and facilitate dissection. This prospective study was carried out to examine possible effect of different anesthesia techniques on oxidative stress and endothelial dysfunction connected with ischemia-reperfusion injury during extremity operations at children's age. Patients were randomized into three groups of 15 patients each: general inhalational anesthesia with sevoflurane (group S), total intravenous anesthesia with propofol (group T) and regional anesthesia (group R). Venous blood samples for determination of the malondialdehyde in plasma and erythrocytes, protein carbonyl groups concentration as well as plasma nitrites and nitrates level and xanthine oxidase activity were obtained at four time points: before peripheral nerve block and induction of general anesthesia (baseline), 1 min before tourniquet release, 5 and 20 min after tourniquet release. This study demonstrates that total intravenous anesthesia with propofol and regional anesthesia techniques provide better antioxidant defense and reduce endothelial dysfunction than general inhalational anesthesia with sevoflurane during tourniquet application in pediatric extremity surgery.",2011,"Patients were randomized into three groups of 15 patients each: general inhalational anesthesia with sevoflurane (group S), total intravenous anesthesia with propofol (group T) and regional anesthesia (group R).","[""extremity operations at children's age"", 'children', 'pediatric extremity surgery']","['propofol and regional anesthesia techniques', 'sevoflurane', 'Pneumatic tourniquets', 'anesthesia techniques', 'general inhalational anesthesia with sevoflurane (group S), total intravenous anesthesia with propofol (group T) and regional anesthesia (group R']","['oxidative stress and endothelial dysfunction', 'plasma nitrites and nitrates level and xanthine oxidase activity', 'endothelial dysfunction']","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043317', 'cui_str': 'Hypoxanthine Dehydrogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0124253,"Patients were randomized into three groups of 15 patients each: general inhalational anesthesia with sevoflurane (group S), total intravenous anesthesia with propofol (group T) and regional anesthesia (group R).","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Budic', 'Affiliation': 'Centre for Anesthesiology and Reanimatology, Clinical Centre Nis, Medical Faculty, University of Nis, Nis, Serbia. ibudic@open.telekom.rs'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pavlovic', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kocic', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cvetkovic', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simic', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Basic', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zivanovic', 'Affiliation': ''}]",Physiological research,[]
878,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND


Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes.
AIMS OF THE STUDY


To examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS).
METHODS


Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial ends.
RESULTS


Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P < .01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P < .01).
CONCLUSIONS


The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first-treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287']
879,31791858,"Corrigendum to ""Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention"" [Contemp Clin Trials 85 (2019) 105834].",,2020,,[],[],[],[],[],[],,0.0595127,,"[{'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA. Electronic address: Jaimie.davis@austin.utexas.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nikah', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'Department of Pediatrics, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Texas A&M AgriLife Extension Service, Travis County, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Van Den Berg', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Bluestein', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105906']
880,32128615,"Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy.","PURPOSE


We assessed the efficacy of aprepitant (APR) or 10 or 5 mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC).
METHODS


Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2-4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2-3 or OLN10 or OLN5 on days 1-4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120 h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life.
RESULTS


Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2-4 nausea were experienced by fewer patients for OLN10 than for APR (24-120 h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups.
CONCLUSIONS


Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.",2020,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","['Of 141 patients, 104 received AC and 37 received', 'patients receiving high-emetogenic chemotherapy (HEC', 'Patients who received', 'patients receiving high-emetogenic chemotherapy']","['ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone', 'placebo', 'cisplatin', 'olanzapine with ondansetron plus dexamethasone', 'aprepitant (APR) or 10 or 5\xa0mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone', 'APR125', 'OLN10 or OLN5', 'doxorubicin + cyclophosphamide or cisplatin']","['nausea and vomiting', 'median visual analog scale nausea score', 'CINV', 'degrees of vomiting, CR, and AE', 'CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life', 'Grades 2-4 nausea', 'no-nausea rates', 'nausea/vomiting (CINV) prophylaxis', 'nausea', 'CINV prevention efficacy']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",141.0,0.4139,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","[{'ForeName': 'Suthinee', 'Initials': 'S', 'LastName': 'Ithimakin', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand. aesi105@yahoo.co.th.'}, {'ForeName': 'Pathra', 'Initials': 'P', 'LastName': 'Theeratrakul', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Apirom', 'Initials': 'A', 'LastName': 'Laocharoenkiat', 'Affiliation': 'Pharmacy Department, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Akarin', 'Initials': 'A', 'LastName': 'Nimmannit', 'Affiliation': 'Department of Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Nopadol', 'Initials': 'N', 'LastName': 'Soparattanapaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Sirisopa', 'Initials': 'S', 'LastName': 'Techawattanawanna', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Krittiya', 'Initials': 'K', 'LastName': 'Korphaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Pongwut', 'Initials': 'P', 'LastName': 'Danchaivijitr', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05380-6']
881,30768462,Randomized Trial Comparing Early and Late Administration of Rocuronium Before and After Checking Mask Ventilation in Patients With Normal Airways.,"BACKGROUND


During induction of general anesthesia, it is common practice to delay neuromuscular blockade until the ability to deliver mask ventilation has been confirmed. However, the benefits of this approach have never been scientifically validated. We thus compared the early and late administration of rocuronium before and after checking mask ventilation to investigate the efficiency of mask ventilation and the time to tracheal intubation in patients with normal airways.
METHODS


Patients (n = 114) were randomized to receive IV rocuronium either before (early rocuronium group, n = 58) or after (late rocuronium group, n = 56) checking mask ventilation. Expiratory tidal volumes (VTs) were measured at 10, 20, 30, 40, 50, and 60 seconds after apnea during mask ventilation. We graded the ease of mask ventilation and measured the time from apnea to tracheal intubation. The primary outcome was the average of mask VTs measured at 10, 20, 30, 40, 50, and 60 seconds after apnea. The main secondary outcome was the time from apnea to tracheal intubation. STATA was used for statistical analysis.
RESULTS


The average of mask VTs measured at 10, 20, 30, 40, 50, and 60 seconds after apnea was larger in the early rocuronium group than in the late rocuronium group (552 mL breath [165 mL breath] vs 393 mL breath [165 mL breath], mean difference, 160 mL breath; 95% CI, 98-221 mL breath; P < .001, unpaired t test). Because the interaction between time and group was significant in mask VTs measured at 10, 20, 30, 40, 50, and 60 seconds after apnea (P < .001, linear mixed effects model), pairwise comparisons were performed at the 6 time points. The differences in VTs between the groups were significant at 10, 20, 30, 40, and 50 seconds after apnea (P < .001 each, contrast statements in STATA). The time from apnea to tracheal intubation was shorter in the early rocuronium group than in the late rocuronium group (116 seconds [42 seconds] vs 195 seconds [41 seconds]; mean difference, -79 seconds; 95% CI, -96 to -64 seconds, P < .001).
CONCLUSIONS


The early administration of rocuronium before checking mask ventilation resulted in a larger mask VT and earlier tracheal intubation than the late administration of rocuronium after checking mask ventilation in patients with normal airways.",2019,"The time from apnea to tracheal intubation was shorter in the early rocuronium group than in the late rocuronium group (116 seconds [42 seconds] vs 195 seconds [41 seconds]; mean difference, -79 seconds; 95% CI, -96 to -64 seconds, P < .001).
","['Patients With Normal Airways', 'Patients (n = 114', 'patients with normal airways']","['rocuronium group, n = 56) checking mask ventilation', 'IV rocuronium', 'rocuronium', 'Checking Mask Ventilation', 'Rocuronium']","['larger mask VT and earlier tracheal intubation', 'Expiratory tidal volumes (VTs', 'time from apnea to tracheal intubation', 'average of mask VTs', 'mask VTs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",114.0,0.256569,"The time from apnea to tracheal intubation was shorter in the early rocuronium group than in the late rocuronium group (116 seconds [42 seconds] vs 195 seconds [41 seconds]; mean difference, -79 seconds; 95% CI, -96 to -64 seconds, P < .001).
","[{'ForeName': 'Se-Hee', 'Initials': 'SH', 'LastName': 'Min', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunjae', 'Initials': 'H', 'LastName': 'Im', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, National Cancer Center, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Bo Rim', 'Initials': 'BR', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Hwa', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004060']
882,32430775,"Comparison of clinical efficacy and patient acceptance of interdental brush and silicone coated interdental pick: a randomized split-mouth, prospective clinical trial.","OBJECTIVES


The aim of this split-mouth, prospective controlled study was to compare the effects of two different interdental devices on clinical plaque elimination, gingival bleeding and patient acceptance and comfort.
MATERIALS AND METHODS


Thirty participants who had been diagnosed with gingivitis were included in the study. After professional oral prophylaxis and a 3-day washout period, patients were advised to use two test devices (TePe Interdental Brushes Original and TePe EasyPick™, Malmö, Sweden) according to instructions. The plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index) were recorded at baseline and after 2 weeks. Patient satisfaction and comfort were assessed with a questionnaire.
RESULTS


Both of the tested devices improved the plaque and bleeding index scores. There were no differences between the two sides in terms of time-dependent changes. The patients felt more satisfied with the cleansing capacity and more comfortable with the use of SCIP compared with IDB (p = 0.001). Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
CONCLUSION


The clinical efficiency of the tested interdental devices was similar in terms of removing plaque and decreasing bleeding. However, SCIP were found to be more comfortable and preferable to IDB.
CLINICAL RELEVANCE


The silicone coated interdental picks showed similar effects on plaque removal as interdental brushes and superiority in terms of ease to use than interdental brushes.",2020,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
",['Thirty participants who had been diagnosed with gingivitis were included in the study'],['interdental brush and silicone coated interdental pick'],"['plaque and bleeding index scores', 'clinical plaque elimination, gingival bleeding and patient acceptance and comfort', 'plaque removal', 'plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index', 'Pain sensation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",30.0,0.0542861,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ercan', 'Affiliation': 'Department of Periodontology, Çanakkale Onsekiz Mart University, Çanakkale, Turkey. esraercan82@gmail.com.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03293-6']
883,30838382,Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.,"OBJECTIVES


Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS.
METHODS


The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors.
RESULTS


One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103 108 Danish Kroner (Dkr) (€13 818) and 134 945 Dkr (€18 085) by thoracotomy, making the costs for VATS 31 837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29 247 Dkr vs thoracotomy 51 734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51 412 Dkr vs thoracotomy 61 575 Dkr; P = 0.012).
CONCLUSIONS


VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01278888.",2019,The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021,"['945', 'All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors', 'lung cancer', 'One hundred and three VATS patients and 103 thoracotomy patients', 'for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014']","['Minimally invasive video-assisted thoracic surgery (VATS', 'VATS versus thoracotomy', 'minimally invasive surgery', 'VATS']","['Mean costs', 'costs of outpatient visits', 'costs of readmissions', 'costs of resources', 'pain scores and better quality of life', 'overall costs', 'mean length of hospitalization', 'quality-adjusted life years', 'median duration of the surgical procedure']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor (occupation)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.185978,The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bendixen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kronborg', 'Affiliation': 'Centre of Health Economic Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ole Dan', 'Initials': 'OD', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Peter Bjørn', 'Initials': 'PB', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz064']
884,32073608,Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner On High-Calorie as Well as Low-Calorie Meals.,"BACKGROUND


The question of whether there is daytime time variation in diet-induced thermogenesis (DIT) has not been clearly answered. Moreover, it is unclear whether a potential diurnal variation in DIT is preserved during hypocaloric nutrition.
OBJECTIVE


We hypothesized that DIT varies depending on the time of day and explored whether this physiological regulation is preserved after low-calorie compared with high-calorie intake.
DESIGN


Under blinded conditions, 16 normal-weight men twice underwent a 3-day in-laboratory, randomized, crossover study. Volunteers consumed a predetermined low-calorie breakfast (11% of individual daily kilocalorie requirement) and high-calorie dinner (69%) in one condition and vice versa in the other. DIT was measured by indirect calorimetry, parameters of glucose metabolism were determined, and hunger and appetite for sweets were rated on a scale.
RESULTS


Identical calorie consumption led to a 2.5-times higher DIT increase in the morning than in the evening after high-calorie and low-calorie meals (P < .001). The food-induced increase of blood glucose and insulin concentrations was diminished after breakfast compared with dinner (P < .001). Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
CONCLUSIONS


DIT is clearly higher in the morning than in the evening, irrespective of the consumed calorie amount; that is, this physiological rhythmicity is preserved during hypocaloric nutrition. Extensive breakfasting should therefore be preferred over large dinner meals to prevent obesity and high blood glucose peaks even under conditions of a hypocaloric diet.",2020,"Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
",['16 normal-weight men twice underwent a 3-day in-laboratory'],"['Low-calorie breakfast', 'High Diet-Induced Thermogenesis', 'Breakfast vs Dinner']","['blood glucose and insulin concentrations', 'appetite for sweets', 'hunger and appetite for sweets', 'feelings of hunger']","[{'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0978093,"Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
","[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Herzog', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Janka', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Thalke', 'Initials': 'T', 'LastName': 'Baumann', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Kistenmacher', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz311']
885,31536116,Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial.,"INTRODUCTION


Compared with the general smoking population, low-income smokers face elevated challenges to success in evidence-based smoking cessation treatment. Moreover, their children bear increased disease burden. Understanding behavioral mechanisms related to successful reduction of child tobacco smoke exposure (TSE) could inform future smoking interventions in vulnerable, underserved populations.
METHODS


Smoking parents were recruited from pediatric clinics in low-income communities and randomized into a multilevel intervention including a pediatric clinic intervention framed in best clinical practice guidelines (""Ask, Advise, Refer"" [AAR]) plus individualized telephone counseling (AAR + counseling), or AAR + control. Mediation analysis included treatment condition (independent variable), 12-month child cotinine (TSE biomarker, criterion), and four mediators: 3-month end-of-treatment self-efficacy to protect children from TSE and smoking urge coping skills, and 12-month perceived program (intra-treatment) support and bioverified smoking abstinence. Analyses controlled for baseline nicotine dependence, depressive symptoms, child age, and presence of other residential smokers.
RESULTS


Participants (n = 327) included 83% women and 83% African Americans. Multilevel AAR + counseling was associated with significantly higher levels of all four mediators (ps < .05). Baseline nicotine dependence (p < .05), 3-month self-efficacy (p < .05) and 12-month bioverified smoking abstinence (p < .001) related significantly to 12-month child cotinine outcome. The indirect effects of AAR + counseling intervention on cotinine via self-efficacy for child TSE protection and smoking abstinence (ps < .05) suggested mediation through these pathways.
CONCLUSIONS


Compared with AAR + control, multilevel AAR + counseling improved all putative mediators. Findings suggest that fostering TSE protection self-efficacy during intervention and encouraging parental smoking abstinence may be key to promoting long-term child TSE-reduction in populations of smokers with elevated challenges to quitting smoking.
IMPLICATIONS


Pediatric harm reduction interventions to protect children of smokers from tobacco smoke have emerged to address tobacco-related health disparities in underserved populations. Low-income smokers experience greater tobacco-related disease burden and more difficulty with smoking behavior change in standard evidence-based interventions than the general population of smokers. Therefore, improving knowledge about putative behavioral mechanisms of smoking behavior change that results in lower child exposure risk could inform future intervention improvements.",2020,Multilevel AAR+counseling was associated with significantly higher levels of all four mediators (p's<.05).,"['Smoking parents were recruited from pediatric clinics in low-income communities and randomized into a', 'Participants (n=327) included 83% women and 83% African Americans', 'child cotinine at 12-month follow-up']","['AAR+counseling intervention', 'child tobacco smoke exposure (TSE', 'multilevel intervention including a pediatric clinic intervention framed in best clinical practice guidelines (""Ask, Advise, Refer [AAR]) plus individualized telephone counseling (AAR+counseling), or AAR+control']","['12-month child cotinine (TSE biomarker, criterion), and four mediators: 3-month end-of-treatment self-efficacy to protect children from TSE and smoking urge coping skills, and 12-month perceived program (intra-treatment) support and bioverified smoking abstinence', 'cotinine via self-efficacy for child TSE protection and smoking abstinence', 'Baseline nicotine dependence (p<.05), 3-month self-efficacy (p<.05) and 12-month bioverified smoking abstinence']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}]",,0.0130209,Multilevel AAR+counseling was associated with significantly higher levels of all four mediators (p's<.05).,"[{'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Massachusetts General Hospital for Children, Boston MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sosnowski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz175']
886,31707838,The impact of physicians' recommendations on treatment preference and attitudes: a randomized controlled experiment on shared decision-making.,"Making decisions based on their own evaluation of relevant information and beliefs is very challenging for patients. Many patients feel that they lack the knowledge to make a decision and expect a recommendation by their physician. We conducted an experimental study to examine the impact of physicians' recommendations on the decision-making process. N = 194 medical laypeople were placed in a hypothetical scenario where they suffered from a cruciate ligament rupture and were faced with the decision about a treatment (surgery or physiotherapy). In a 3 × 2 between-group design we investigated the impact of physicians' recommendations (for surgery, for physiotherapy, no recommendation) and reasoning style (scientific, narrative) on treatment preference, certainty and satisfaction regarding treatment preference, and attitudes. We found that the recommendation had a significant influence on treatment preference and attitudes toward both treatments. Additionally, we found a significant increase in certainty and satisfaction after the intervention, independently of whether they received a recommendation. This finding suggested that a recommendation was not required to strengthen participants' confidence in their decision. There were no effects of reasoning style. We discuss the implications and suggest that physicians should be careful with recommendations in situations in which patients' preferences are important.",2020,N = 194 medical laypeople were placed in a hypothetical scenario where they suffered from a cruciate ligament rupture and were faced with the decision about a treatment (surgery or physiotherapy).,[],"[""physicians' recommendations (for surgery, for physiotherapy, no recommendation) and reasoning style (scientific, narrative""]","['certainty and satisfaction', 'reasoning style']",[],"[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0298708,N = 194 medical laypeople were placed in a hypothetical scenario where they suffered from a cruciate ligament rupture and were faced with the decision about a treatment (surgery or physiotherapy).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Cress', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Department of Psychology, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Shiozawa', 'Affiliation': 'Institute of Clinical Anatomy and Cell Analysis, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Department of Psychology, University of Tuebingen, Tuebingen, Germany.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1687917']
887,19786668,"Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer ""unfit"" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986.","PURPOSE


There is no standard treatment for patients with advanced urothelial cancer who are ineligible (""unfit"") for cisplatin-based chemotherapy (CHT). To compare the activity and safety of two CHT combinations in this patient group, a randomized phase II/III trial was conducted by the EORTC (European Organisation for Research and Treatment of Cancer). We report here the phase II results of the study.
PATIENTS AND METHODS


CHT-naïve patients with measurable disease and impaired renal function (30 mL/min < glomerular filtration rate [GFR] < 60 mL/min) and/or performance status (PS) 2 were randomly assigned to receive either GC (gemcitabine 1,000 mg/m(2) on days 1 and 8 and carboplatin area under the serum concentration-time curve [AUC] 4.5) for 21 days or M-CAVI (methotrexate 30 mg/m(2) on days 1, 15, and 22; carboplatin AUC 4.5 on day 1; and vinblastine 3 mg/m(2) on days 1, 15, and 22) for 28 days. End points of response and severe acute toxicity (SAT) were evaluated with respect to treatment group, renal function, PS, and Bajorin risk groups.
RESULTS


Three of 178 patients who were ineligible or did not start treatment were excluded. SAT was reported in 13.6% of patients on GC and in 23% on M-CAVI. Overall response rates were 42% (37 of 88) for GC and 30% (26 of 87) for M-CAVI. Patients with PS 2 and GFR less than 60 mL/min and patients in Bajorin risk group 2 showed a response rate of only 26% and 20% and an SAT rate of 26% and 25%, respectively.
CONCLUSION


Both combinations are active in this group of unfit patients. However, patients with PS 2 and GFR less than 60 mL/min do not benefit from combination CHT. Alternative treatment modalities should be sought in this subgroup of poor-risk patients.",2009,Overall response rates were 42% (37 of 88) for GC and 30% (26 of 87) for M-CAVI.,"['178 patients who were ineligible or did not start treatment were excluded', 'CHT-naïve patients with measurable disease and impaired renal function (30 mL/min < glomerular filtration rate [GFR] < 60 mL/min) and/or performance status (PS) 2', 'patients with advanced urothelial cancer ""unfit"" for', 'patients with advanced urothelial cancer who are ineligible (""unfit"") for', 'subgroup of poor-risk patients']","['M-CAVI (methotrexate', 'gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine', 'carboplatin AUC', 'cisplatin-based chemotherapy (CHT', 'cisplatin-based chemotherapy', 'CHT combinations', 'GC (gemcitabine 1,000 mg/m(2) on days 1 and 8 and carboplatin', 'vinblastine']","['activity and safety', 'response rate', 'SAT', 'Overall response rates', 'renal function, PS, and Bajorin risk groups', 'response and severe acute toxicity (SAT', 'SAT rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]",,0.0381626,Overall response rates were 42% (37 of 88) for GC and 30% (26 of 87) for M-CAVI.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Kaiser Franz Josef Hospital and Applied Cancer Research-Institution for Translational Research, Ludwig Boltzmann-Institute for Applied Cancer Research, Vienna, Austria. maria.desantis@wienkav.at'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ''}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': ''}, {'ForeName': 'J Martijn', 'Initials': 'JM', 'LastName': 'Kerst', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leahy', 'Affiliation': ''}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Maroto', 'Affiliation': ''}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Skoneczna', 'Affiliation': ''}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sylvester', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2008.21.4924']
888,31771179,"Modulation of Gut Microbiota by Glucosamine and Chondroitin in a Randomized, Double-Blind Pilot Trial in Humans.","Glucosamine and chondroitin (G&C), typically taken for joint pain, are among the most frequently used specialty supplements by US adults. More recently, G&C have been associated with lower incidence of colorectal cancer in human observational studies and reduced severity of experimentally-induced ulcerative colitis in rodents. However, little is known about their effects on colon-related physiology. G&C are poorly absorbed and therefore metabolized by gut microbiota. G&C have been associated with changes in microbial structure, which may alter host response. We conducted a randomized, double-blind, placebo-controlled crossover trial in ten healthy adults to evaluate the effects of a common dose of G&C compared to placebo for 14 days on gut microbial community structure, measured by 16S rRNA gene sequencing. Linear mixed models were used to evaluate the effect of G&C compared to placebo on fecal microbial alpha and beta diversity, seven phyla, and 137 genera. Nine genera were significantly different between interventions (False Discovery Rate < 0.05). Abundances of four  Lachnospiraceae  genera, two  Prevotellaceae  genera, and  Desulfovibrio  were increased after G&C compared to placebo, while  Bifidobacterium  and a member of the  Christensenellaceae  family were decreased. Our results suggest that G&C affect the composition of the gut microbiome which may have implications for therapeutic efficacy.",2019,Nine genera were significantly different between interventions (False Discovery Rate < 0.05).,"['Humans', 'ten healthy adults']","['Glucosamine and chondroitin (G&C', 'placebo', 'Glucosamine and Chondroitin', 'G&C']","['Desulfovibrio', 'fecal microbial alpha and beta diversity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008454', 'cui_str': 'Chondroitin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011731', 'cui_str': 'Desulfovibrio'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",10.0,0.276218,Nine genera were significantly different between interventions (False Discovery Rate < 0.05).,"[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Curtis', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}]",Microorganisms,['10.3390/microorganisms7120610']
889,31802697,Does the Healthy Body Image program improve lifestyle habits among high school students? A randomized controlled trial with 12-month follow-up.,"OBJECTIVES


Positive embodiment and healthy lifestyle habits seem to be related; therefore, stimulating positive embodiment should promote healthy lifestyle habits. In the current study, we delivered the Healthy Body Image (HBI) intervention among Norwegian high school students and examined the effects on healthy lifestyle habits.
METHODS


The HBI intervention comprises three interactive workshops, with three overarching themes related to body image, social media literacy, and lifestyle. A total of 2446 boys (43%) and girls in grade 12 (mean age 16.8 years) from 30 high schools participated in this cluster-randomized controlled study. Schools were randomized to the HBI intervention or control study arm. Data on physical activity, eating habits, and sleep were collected at baseline, post intervention, and 3- and 12-month follow-up and analyzed using linear mixed regression models.
RESULTS


The intervention had a minor negative effect on physical activity levels in boys at 12-month follow-up and short-term small-to-moderate positive effects on consumption of breakfast and fruit and vegetables, and sleep duration on school days.
CONCLUSIONS


In future, the lack of satisfactorily long-term effects might be better addressed using a combination of cognitive and behavioral approaches to more optimally integrate positive embodiment and lifestyle changes in the daily life of adolescents. Trial registration:  ClinicalTrials.gov ID: PRSNCT02901457. Approved by the Regional Committee for Medical and Health Research Ethics.",2020,,[],[],['lifestyle habits'],[],[],"[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0322057,,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, Tromsø, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Monica K', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Kristiansand, Norway.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Engen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, Tromsø, Norway.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, Tromsø, Norway.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, Kongsberg, Norway.'}]",The Journal of international medical research,['10.1177/0300060519889453']
890,31525488,Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study.,"OBJECTIVE


Families of ICU patients have a pressing need for information: they find themselves suddenly in a complex technical environment often because of a life-threatening illness of a loved one. Some evidence suggests that specific communication tools (like websites or brochures) could improve the experience of ICU families.
DESIGN


Randomized, multicenter, stepped wedge trial for large-scale assessment of the effectiveness of a multitasking intervention to improve communication with families of critically ill patients.
MAIN OUTCOME


correct understanding of the prognosis.
SECONDARY OUTCOMES


correct understanding of medical treatments, prevalence of anxiety, depression and post-traumatic stress symptoms in the first ICU week. Prevalence of PTSD 6 months from ICU discharge. Empathy and burnout among ICU staff. Prevalence of refusals for tissues/organ donation, and medical claims.
SUBJECTS


2100 ICU relatives of critically ill patients.
INTERVENTIONS


The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
MEASUREMENTS AND MAIN RESULTS


The study plans to assess these materials in up to 300 Italian ICUs that will participate, according to a five waves program, each one with randomized starting order. This way the effect of the intervention will be evaluated simultaneously.
CONCLUSION


This is an educational study, aiming to spread good medical practices, while also verifying their real effectiveness in a large number of ICUs.
TRIAL REGISTRATION NUMBER


NCT03438175.",2019,"The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
","['Families of ICU patients', 'critically ill patients', '2100 ICU relatives of critically ill patients']",['multitasking intervention'],"['medical treatments, prevalence of anxiety, depression and post-traumatic stress symptoms']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}]",2100.0,0.0391207,"The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mistraletti', 'Affiliation': 'Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Italy; SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy. Electronic address: giovanni.mistraletti@unimi.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mezzetti', 'Affiliation': 'AUSL Toscana Centro, SOS 118 Emergenza Territoriale, Empoli, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Anania', 'Affiliation': 'SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ionescu Maddalena', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Negro', 'Affiliation': 'SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy.'}, {'ForeName': 'Gian Domenico', 'Initials': 'GD', 'LastName': 'Giusti', 'Affiliation': 'AOU S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gili', 'Affiliation': 'Dipartimento di Medicina Sperimentale, Università degli Studi di Perugia, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Iacobone', 'Affiliation': 'SAR, Dipartimento Emergenza-Urgenza, AV3 Ospedale di Macerata, ASUR Marche, Italy.'}, {'ForeName': 'Silvia Maria', 'Initials': 'SM', 'LastName': 'Pulitanò', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Bocci', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105847']
891,19392993,The effects of selected probiotic strains on the development of eczema (the PandA study).,"BACKGROUND


Modification of the intestinal microbiota by administration of probiotic bacteria may be a potential approach to prevent allergic disease. We aimed to study primary prevention of allergic disease in high-risk children by pre- and postnatal supplementation of selected probiotic bacteria.
METHODS


In a double-blind, randomized, placebo-controlled trial, a mixture of probiotic bacteria selected by in-vitro experiments (Bifidobacterium bifidum, Bifidobacterium lactis, and Lactococcus lactis; Ecologic Panda) was prenatally administered to mothers of high-risk children (i.e. positive family history of allergic disease) and to their offspring for the first 12 months of life.
RESULTS


Parental-reported eczema during the first 3 months of life was significantly lower in the intervention group compared with placebo, 6/50 vs 15/52 (P = 0.035). After 3 months, the incidence of eczema was similar in both groups. Cumulative incidence of parental-reported eczema at 1 and 2 years was 23/50 (intervention) vs 31/48 (placebo) and 27 (intervention) vs 34 (placebo), respectively. The number needed to treat was 5.9 at age 3 and 12 months and 6.7 at age 2 years. The intervention group was significantly more frequently colonized with higher numbers of Lc. lactis. Furthermore, at age 3 months, in vitro production of IL-5 (146 pg/ml vs 72 pg/ml; P = 0.04) was decreased in the probiotic-group compared with the placebo-group.
CONCLUSIONS


This particular combination of probiotic bacteria shows a preventive effect on the incidence of eczema in high-risk children, which seems to be sustained during the first 2 years of life. In addition to previous studies, the preventive effect appears to be established within the first 3 months of life.",2009,"(146 pg/ml vs 72 pg/ml; P = 0.04) was decreased in the probiotic-group compared with the placebo-group.
","['high-risk children', 'mothers of high-risk children (i.e. positive family history of allergic disease) and to their offspring for the first 12 months of life', 'high-risk children by pre- and postnatal supplementation of selected probiotic bacteria']","['selected probiotic strains', 'placebo', 'probiotic bacteria']","['numbers of Lc', 'Cumulative incidence of parental-reported eczema', 'eczema', 'incidence of eczema', 'vitro production of IL-5']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0033268'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}]",,0.395829,"(146 pg/ml vs 72 pg/ml; P = 0.04) was decreased in the probiotic-group compared with the placebo-group.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Niers', 'Affiliation': ""Department of Pediatrics, Wilhelmina Children's' Hospital, University Medical Center, Utrecht, the Netherlands.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Martín', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rijkers', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sengers', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Timmerman', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Uden', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Smidt', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kimpen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoekstra', 'Affiliation': ''}]",Allergy,['10.1111/j.1398-9995.2009.02021.x']
892,32432388,"Lorecivivint, a Novel Intraarticular CDC-Like Kinase 2 and Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase 1A Inhibitor and Wnt Pathway Modulator for the Treatment of Knee Osteoarthritis: A Phase II Randomized Trial.","OBJECTIVE


To assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to severely symptomatic knee osteoarthritis (OA).
METHODS


Subjects in this 52-week, phase IIa, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial received a single 2-ml intraarticular injection of lorecivivint (dose of 0.03 mg, 0.07 mg, or 0.23 mg) or placebo. Efficacy was assessed based on change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score subscales for pain and function (scale 0-100 for each) and change from baseline in the radiographic medial joint space width (JSW). Baseline-adjusted analysis of covariance with multiple imputation was performed separately to evaluate efficacy. This proof-of-concept study evaluated the intent-to-treat population as well as a prespecified group of subjects with unilateral symptoms of knee OA (designated UNI) and an additional post hoc subgroup of subjects with unilateral symptoms but without widespread pain (designated UNI WP-).
RESULTS


In this trial, 455 subjects were randomized to a treatment group. The primary end point, significant improvement in the WOMAC pain score compared with placebo at week 13, was not met by any lorecivivint dose group (mean ± SD change from baseline, -23.3 ± 2.2 in the 0.03 mg group, -23.5 ± 2.1 in the 0.07 mg group, -21.3 ± 2.2 in the 0.23 mg group, and -22.1 ± 2.1 in the placebo group; each P > 0.05 versus placebo). All groups (including placebo) demonstrated clinically meaningful (≥20-point) improvements from baseline in the WOMAC pain score. The durability of response was evaluated through week 52. In the prespecified UNI group and post hoc UNI WP- group at week 52, treatment with 0.07 mg lorecivivint significantly improved the WOMAC pain score (between-group difference versus placebo, -8.73, 95% confidence interval [95% CI] -17.44, -0.03 [P = 0.049] and -11.21, 95% CI -20.99, -1.43 [P = 0.025], respectively) and WOMAC function score (between-group difference versus placebo, -10.26, 95% CI -19.82, -0.69 [P = 0.036] and -13.38, 95% CI -24.33, -2.43 [P = 0.017], respectively). Relative to baseline, the mean change in the medial JSW at week 52 was -0.04 mm in the 0.03 mg cohort, -0.09 mm in the 0.07 mg cohort, -0.16 mm in the 0.23 mg cohort, and -0.14 mm in the placebo cohort; no treatment group achieved a significant change in medial JSW compared with placebo at week 52. In both unilateral symptom subgroups, the 0.07 mg lorecivivint dose significantly increased medial JSW compared with placebo at week 52 (medial JSW 0.39 mm, 95% CI 0.06, 0.72 in the UNI group [P = 0.021] and 0.42 mm, 95% CI 0.04, 0.80 in the UNI WP- group [P = 0.032]). Changes observed in the 0.03 mg and 0.23 mg dose groups were not significantly different from those in the placebo group for any of these measures. Lorecivivint appeared safe and well tolerated.
CONCLUSION


This phase IIa, proof-of-concept trial in patients with symptomatic knee OA did not meet its primary end point. Nevertheless, the study identified a target population in whom to evaluate the potential efficacy of lorecivivint for the treatment of knee OA.",2020,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","['Subjects', 'Four hundred fifty-five subjects were randomized', 'Knee Osteoarthritis', 'subjects with unilateral symptoms (UNI) and an additional post hoc subgroup of unilateral symptomatic subjects without widespread pain (UNI WP', 'moderate-to-severe symptomatic knee osteoarthritis (OA']","['placebo (PBO)-controlled', 'novel Wnt pathway modulator lorecivivint (SM04690']","['mean change in mJSW', 'mJSW', 'durability of response', 'WOMAC Pain [0-100] and WOMAC Function [0-100] subscales and radiographic medial joint space width (mJSW', 'safety and efficacy', 'Efficacy', 'safe and well tolerated', 'WOMAC Function', 'WOMAC Pain']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1520113', 'cui_str': 'Wnt Pathway'}, {'cui': 'C4706114', 'cui_str': 'SM04690'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",455.0,0.138937,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yazici', 'Affiliation': 'Samumed LLC, San Diego, California.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Gibofsky', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'UC Davis Medical School, Burlingame, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Clauw', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bergfeld', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Swearingen', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'DiFrancesco', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Simsek', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Jeyanesh', 'Initials': 'J', 'LastName': 'Tambiah', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41315']
893,31529767,Association of the eukaryotic vaginal virome with prophylactic antibiotic exposure and reproductive outcomes in a subfertile population undergoing in vitro fertilisation: a prospective exploratory study.,"OBJECTIVE


The objective of this study was to use high-throughput sequencing to describe the vaginal eukaryotic DNA virome in patients undergoing in vitro fertilisation (IVF) to examine associations between the vaginal virome, antibiotic exposure and IVF outcomes.
DESIGN


Prospective exploratory study.
SETTING


Single academic fertility centre.
POPULATION


Subfertile women age 18-43 years undergoing their first IVF cycle with a fresh embryo transfer.
METHODS


The primary exposure was prophylactic azithromycin or no azithromycin before IVF. A mid-vaginal swab was obtained at the time of embryo transfer for virome analysis.
MAIN OUTCOME MEASURES


The primary outcomes compared between exposure groups were characteristics of vaginal virome and clinical pregnancy rates. Secondary outcomes were virome associations with number of oocytes retrieved, number of blastocysts and implantation rate.
RESULTS


Twenty-six women contributed a vaginal swab before embryo transfer. There were no significant differences in IVF outcomes between azithromycin groups. There was no association between viral diversity and clinical pregnancy overall. A higher diversity of herpesviruses and α-papillomaviruses was observed in samples from the azithromycin-treated group compared with the no azithromycin group (P = 0.04). In women that received azithromycin, viral diversity was higher in the group that did not achieve clinical pregnancy compared with those who did (P = 0.06).
CONCLUSIONS


We demonstrate that the vaginal eukaryotic virome in women undergoing IVF is associated with antibiotic exposure. Additionally, we demonstrate an inverse trend between viral diversity and pregnancy, with a higher number of viruses detected associated with failure to achieve clinical pregnancy in the azithromycin group.
TWEETABLE ABSTRACT


Higher viral diversity is associated with prophylactic antibiotic exposure in subfertile women undergoing IVF.",2020,A higher diversity of herpesviruses and α-papillomaviruses was observed in samples from the azithromycin-treated group compared with the no azithromycin group (P = 0.04).,"['patients undergoing in vitro fertilisation (IVF', 'subfertile population undergoing in vitro fertilisation', 'Single academic fertility centre', 'subfertile women undergoing IVF', 'Twenty-six women contributed a vaginal swab before embryo transfer', 'Subfertile women age 18-43\xa0years undergoing their first IVF cycle with a fresh embryo transfer']","['azithromycin', 'eukaryotic vaginal virome with prophylactic antibiotic exposure']","['viral diversity and clinical pregnancy overall', 'diversity of herpesviruses and α-papillomaviruses', 'viral diversity', 'virome associations with number of oocytes retrieved, number of blastocysts and implantation rate', 'clinical pregnancy', 'characteristics of vaginal virome and clinical pregnancy rates', 'viral diversity and pregnancy', 'IVF outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019369', 'cui_str': 'Herpesviruses'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]",,0.186045,A higher diversity of herpesviruses and α-papillomaviruses was observed in samples from the azithromycin-treated group compared with the no azithromycin group (P = 0.04).,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Eskew', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Stout', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Bedrick', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Riley', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Omurtag', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Jimenez', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Odem', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Ratts', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Keller', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Jungheim', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Wylie', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Washington University in St Louis, St Louis, MO, USA.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15951']
894,31426669,Nordic walking and standard exercise therapy in patients with chronic heart failure: A randomised controlled trial comparison.,,2019,,['patients with chronic heart failure'],['Nordic walking and standard exercise therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]",[],,0.084426,,"[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Prince', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Evyanne', 'Initials': 'E', 'LastName': 'Wooding', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mielniczuk', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Kwan-Leung', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Marja-Leena', 'Initials': 'ML', 'LastName': 'Keast', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mark', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cotie', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}]",European journal of preventive cardiology,['10.1177/2047487319871215']
895,31525490,CHAMP: A cluster randomized-control trial to prevent obesity in child care centers.,"Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prevention interventions, limited attention has been directed to criteria needed for implementation at scale. There is potential to improve children's dietary and physical activity behaviors in diverse communities through theory-based, culturally appropriate, manualized interventions, delivered by child care staff. CHAMP (Creating Healthy Habits Among Maryland Preschoolers) is a 3-arm cluster randomized controlled childhood obesity prevention trial, aiming to improve motor skills, physical activity and willingness to try new foods among 864 preschoolers (age 3-5 years) enrolled in 54 child care centers in 10 Maryland counties. CHAMP is informed by social-cognitive and bioecological theories and based on an evidence-based program, The Food Friends®. The two intervention arms include: 1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons. Evaluations are conducted among children, caregivers, and child care staff at fall enrollment, midline, and spring, following intervention completion. Analyses include linear mixed-models, accounting for clustering and repeated measures, incorporating center-arms as moderators. CHAMP will provide evidence-based information to inform wellness guidelines and policies that can be disseminated broadly, to ensure that child care centers provide opportunities for children to develop healthy eating, and physical activity habits. Trial Registration: NCT03111264; https://clinicaltrials.gov/ct2/show/NCT03111264.",2019,Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity.,"['864 preschoolers (age 3-5\u202fyears) enrolled in 54 child care centers in 10 Maryland counties', 'child care centers', 'Creating Healthy Habits', 'Maryland Preschoolers']","['1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons', 'CHAMP', 'CHAMP ']","[""children's dietary and physical activity behaviors"", 'Child care attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}]",864.0,0.0374942,Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity.,"[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Angela C B', 'Initials': 'ACB', 'LastName': 'Trude', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Romulus J', 'Initials': 'RJ', 'LastName': 'Castelo', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zemanick', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Haber-Sage', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Arbaiza', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America; RTI International, Department of Pediatrics, United States of America. Electronic address: mblack@som.umaryland.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105849']
896,32128614,"Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial.","PURPOSE


Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS.
METHODS


A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a ""slight improvement.""
RESULTS


Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS.
CONCLUSION


TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least ""slight pain relief"" from PBT. Differences for gender and incident pain aspects demand future trials.",2020,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","['11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N\u2009=\u200920', '632 patients screened, 25', 'advanced cancer pain inpatients in specialist palliative care', 'adult inpatients with cancer pain ≥\u20093 on an 11-point numerical rating scale (NRS', 'inpatient specialist palliative care ward', 'Women and patients with incident pain']","['Transcutaneous electrical nerve stimulation (TENS', 'placebo TENS (PBT', 'Intensity-modulated high TENS (IMT', 'TENS', 'Transcutaneous electrical nerve stimulation']","['average pain intensity', 'uncomfortable feeling', 'slight improvement', 'analgesic effects', 'responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0222045'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",25.0,0.274577,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","[{'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Siemens', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany. waldemar.siemens@googlemail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Boehlke', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Bennett', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences (LIHS), School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Offner', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gaertner', 'Affiliation': 'Center for Palliative Care Hildegard, Basel, Switzerland.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05370-8']
897,32075571,Primary intraventricular hemorrhage outcomes in the CLEAR III trial.,"BACKGROUND


Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage.
AIMS


We evaluated the prognosis of primary intraventricular hemorrhage patients in the CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage).
METHODS


In patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage, we compared intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS) at 30, 180, and 365 days. Outcomes were also compared in primary intraventricular hemorrhage patients who received intraventricular alteplase versus placebo (normal saline) and in matched primary and secondary intraventricular hemorrhage patients using inverse-probability-weighted regression adjustment.
RESULTS


Of 500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage. Combining both treatment groups, primary intraventricular hemorrhage patients had larger intraventricular hemorrhage volumes (median: 34.2 mL vs. 20.8 mL,  p  < 0.01) but similar intraventricular hemorrhage removal (51.0% vs. 59.0%,  p  = 0.24) compared to secondary intraventricular hemorrhage patients, respectively. Confirming previous studies, primary intraventricular hemorrhage patients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all  p  < 0.01), although mortality was similar to secondary intraventricular hemorrhage patients; matching analysis yielded similar results. Primary intraventricular hemorrhage patients who received intraventricular alteplase ( n  = 19) and saline ( n  = 27) achieved similar outcomes.
CONCLUSIONS


In CLEAR III, primary intraventricular hemorrhage patients who survived achieved better long-term outcomes than surviving secondary intraventricular hemorrhage patients with similar mortality. Outcomes and safety were similar between primary intraventricular hemorrhage patients receiving alteplase and those receiving saline.",2020,"Confirming previous studies, primary intraventricular hemorrhage patients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all  p  < 0.01), although mortality was similar to secondary intraventricular hemorrhage patients; matching analysis yielded similar results.","['Primary intraventricular hemorrhage patients', '500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage', 'patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage', 'primary intraventricular hemorrhage patients in the CLEAR III trial (Clot Lysis']","['placebo (normal saline', 'intraventricular alteplase', 'saline']","['mortality', 'NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores', 'intraventricular hemorrhage removal', 'larger intraventricular hemorrhage volumes', 'intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS', 'Primary intraventricular hemorrhage outcomes']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",500.0,0.267587,"Confirming previous studies, primary intraventricular hemorrhage patients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all  p  < 0.01), although mortality was similar to secondary intraventricular hemorrhage patients; matching analysis yielded similar results.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Nelson', 'Affiliation': 'Departments of Neurology and Anesthesiology/Critical Care Medicine, 1466Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'W Andrew', 'Initials': 'WA', 'LastName': 'Mould', 'Affiliation': 'Division of Brain Injury Outcomes, 1466Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Gandhi', 'Affiliation': 'Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, 1466Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salter', 'Affiliation': 'Department of Biostatistics, 1466Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, 1466Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'Section of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Departments of Neurology and Anesthesiology/Critical Care Medicine, 1466Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ziai', 'Affiliation': 'Departments of Neurology and Anesthesiology/Critical Care Medicine, 1466Johns Hopkins University, Baltimore, MD, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020908146']
898,32075817,Effectiveness of an innovative and comprehensive eye care model for individuals in residential care facilities: results of the residential ocular care (ROC) multicentred randomised controlled trial.,"BACKGROUND


To assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care.
METHODS


In this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015-2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms.
RESULTS


At 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed.
CONCLUSION


Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted.",2020,"Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment.","['38 Australian aged-care facilities (2015-2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women', 'residential care dwellers in Australia with vision impairment', 'Australian individuals residing in residential care', 'individuals in residential care facilities']","['innovative and comprehensive eye care model', 'ROC', 'usual care', 'novel residential ocular care (ROC) model']","['presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency', 'PNVA, Emotional and QoV scores', 'near vision, emotional well-being and perceived burden of vision-related symptoms']","[{'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",38.0,0.308666,"Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment.","[{'ForeName': 'Ryan Eyn Kidd', 'Initials': 'REK', 'LastName': 'Man', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Alfred Tau Liang', 'Initials': 'ATL', 'LastName': 'Gan', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Fenwick', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holloway', 'Affiliation': 'Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-National University of Singapore Medical School, Singapore, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coote', 'Affiliation': 'Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'National Vision Research Institute, Australian College of Optometry, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gwyn', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Ecosse Luc', 'Initials': 'EL', 'LastName': 'Lamoureux', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore ecosse@unimelb.edu.au.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315620']
899,32017597,Pulse Wave Velocity in Chronic Obstructive Pulmonary Disease and the Impact of Inhaled Therapy (SUMMIT): A Randomized Double-Blind Clinical Trial.,,2020,,[],['Inhaled Therapy (SUMMIT'],[],[],"[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.735713,,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'GlaxoSmithKline plcMiddlesex, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'University Hospital AintreeLiverpool, United Kingdom.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical SchoolBoston, Massachusetts.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Veramed Ltd.Twickenham, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell MedicineNew York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of EdinburghEdinburgh, United Kingdom.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The University of Manchester Manchester, United Kingdom.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of MichiganAnn Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1639LE']
900,32432443,Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation Improves Limits of Postural Stability in Older Adults.,"BACKGROUND


The study aimed to determine whether improved muscle strength after 12 weeks of neuromuscular electrical stimulation (NMES) of plantar and dorsiflexors could result in better limits of stability in older adults.
METHODS


Twenty-seven participants were divided into a control group and a neuromuscular home-based training group. The training group performed a 3-month long NMES training of both plantar and dorsiflexors. Ankle flexor strength and limits of stability were measured. A mediation analysis was conducted to determine whether the NMES effect on the limits of stability was mediated by increased strength.
RESULTS


The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02). The effect of the NMES on the limits of stability was fully mediated by the plantar flexor strength increase (indirect effect: β = 0.1146; 95% confidence interval, 0.020-0.240).
CONCLUSION


It seems that NMES improves the limits of stability through its positive effect on muscle strength. NMES may be utilized in fall-prevention programs.",2020,"The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02).","['Twenty-seven participants', 'Older Adults', 'older adults']","['neuromuscular electrical stimulation (NMES) of plantar and dorsiflexors', 'NMES training of both plantar and dorsiflexors', 'NMES', 'neuromuscular home-based training group', 'Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation']","['plantar flexor strength', 'anterior limits of stability improvement', 'plantar flexor strength increase', 'Postural Stability', 'Ankle flexor strength and limits of stability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]",27.0,0.0483137,"The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02).","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Langeard', 'Affiliation': ''}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Loggia', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chastan', 'Affiliation': ''}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Quarck', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0501']
901,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
902,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
903,32427667,Racial Differences in the Influence of Health Care System Factors on Informal Support for Cancer Care Among Black and White Breast and Lung Cancer Survivors.,"This retrospective, secondary qualitative analysis investigates whether health system factors influence social support among Black and white breast and lung cancer survivors and racial differences in support. These data come from race- and cancer-stratified focus groups (n = 6) and interviews (n = 2) to inform a randomized controlled trial utilizing antiracism and community-based participatory research approaches. Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted. Resources within individual support networks reflect broader sociostructural factors. Reliance on family/friends to fill gaps in cancer care may exacerbate racial disparities.",2020,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","['Cancer Care', 'Black and White Breast and Lung Cancer Survivors', 'Black and white breast and lung cancer survivors']",['health system factors influence social support'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",[],6.0,0.0371642,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","[{'ForeName': 'Katrina R', 'Initials': 'KR', 'LastName': 'Ellis', 'Affiliation': 'Greensboro Health Disparities Collaborative, North Carolina (Drs Ellis, Black, Baker, Davis, Doost, Lightfoot, Samuel, Schaal, and Eng and Mss Cothern, Goestch, Griesemer, Guerrab, Padilla, and Yongue); School of Social Work, University of Michigan, Ann Arbor (Dr Ellis); College of Health and Human Performance, East Carolina University, Greenville (Dr Black); Public Health Studies Program, Elon University, North Carolina (Dr Baker); School of Medicine, Washington University, St Louis, Missouri (Dr Davis); Departments of Health Behavior (Mss Griesemer and Guerrab and Drs Lightfoot and Eng) and Health Policy and Management (Ms Padilla and Dr Samuel), University of North Carolina, Chapel Hill; Center for Health Promotion and Disease Prevention, University of North Carolina (Dr Lightfoot); The Partnership Project, Inc, Greensboro, North Carolina (Dr Schaal); and Department of Public Health Education, University of North Carolina at Greensboro (Ms Yongue).'}, {'ForeName': 'Kristin Z', 'Initials': 'KZ', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cothern', 'Affiliation': ''}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Doost', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Goestch', 'Affiliation': ''}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Guerrab', 'Affiliation': ''}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Lightfoot', 'Affiliation': ''}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': ''}, {'ForeName': 'Cleo A', 'Initials': 'CA', 'LastName': 'Samuel', 'Affiliation': ''}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Schaal', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yongue', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000264']
904,32432448,Game-based versus multilateral approach: effects of a 12-week program on motor skill acquisition and physical fitness development in soccer school children.,"BACKGROUND


The purpose of this study was to investigate the effects of a 12-week-game-based training versus a traditional multilateral approach on motor skills acquisition and physical fitness, in a group of U9 children playing soccer.
METHODS


Forty children aged 9 or younger (U9) recruited from a local soccer school were assigned in a 1:1 ratio to a game-based training program (GB) or a multilateral training (MA) approach. The training programs lasted 12 weeks, and players were tested at baseline and at the end of the program (12-week follow-up). The outcomes were: standing long jump test, shuttle dribble test, 10×5 shuttle run test and Mini-Cooper test.
RESULTS


Within-group comparisons showed statistically-significant improvements in both of the groups: standing long lump (P<0.0001), shuttle dribble test (P<0.0001), shuttle run test (P<0.0001) and Mini-Cooper test (P<0.0001). Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (P=0.0002; +8%).
CONCLUSIONS


A multilateral approach promotes physical development in U9 soccer players without affecting learning of-soccer skills. Therefore, a multilateral approach should be included in soccer training programs to ensure an optimal development in young soccer players.",2020,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","['U9 soccer players without affecting learning of soccer skills', '40 Children 9 years old or younger (U9) recruited from a local soccer school', 'soccer school children', 'young soccer players', 'U9 children playing soccer']","['12-week- game-based training versus a traditional multilateral approach', 'game-based training program (GB) or a multilateral training (MA) approach']","['shuttle dribble test', 'motor skill acquisition and physical fitness development', 'motor skills acquisition and physical fitness', 'standing long jump test, shuttle dribble test, 10x5 shuttle run test and Mini-Cooper test', 'standing long lump']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",40.0,0.020152,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Abate Daga', 'Affiliation': 'Department of Medical Sciences, University of Turin, Turin, Italy - federico.abatedaga@unito.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baseggio', 'Affiliation': 'Department of Medical Sciences, School of Exercise and Sport Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Gollin', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Beratto', 'Affiliation': 'Department of Medical Sciences, School of Exercise and Sport Sciences, University of Turin, Turin, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10726-6']
905,31894446,Predictors of contralateral prophylactic mastectomy in genetically high risk newly diagnosed breast cancer patients.,"PURPOSE


Recent trends indicate increased use of contralateral prophylactic mastectomy (CPM) among newly diagnosed breast cancer patients, particularly those who test positive for a pathogenic variant in the BRCA1/2 genes. However, the rate of CPM among patients who test negative or choose not to be tested is surprisingly high. We aimed to identify patient predictors of CPM following breast cancer diagnosis among such patients.
METHODS


As part of a randomized controlled trial of rapid genetic counseling and testing vs. usual care, breast cancer patients completed a baseline survey within 6 weeks of diagnosis and before definitive surgery. Analyses focused on patients who opted against testing (n = 136) or who received negative BRCA1/2 test results (n = 149). We used multivariable logistic regression to assess the associations between sociodemographic, clinical- and patient-reported factors with use of CPM.
RESULTS


Among patients who were untested or who received negative test results, having discussed CPM with one's surgeon at the time of diagnosis predicted subsequent CPM. Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM.
CONCLUSION


The strongest predictors of CPM in this population were objective clinical factors and discussion with providers. However, baseline psychosocial factors were also independently related to the receipt of CPM. Thus, although CPM decisions are largely guided by relevant clinical factors, it is important to attend to psychosocial factors when counseling newly diagnosed breast cancer patients about treatment options.",2020,"Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM.
CONCLUSION


","['newly diagnosed breast cancer patients', 'patients who opted against testing (n\u2009=\u2009136) or who received negative BRCA1/2 test results (n\u2009=\u2009149', 'genetically high risk newly diagnosed breast cancer patients', ' breast cancer patients completed a baseline survey within 6\xa0weeks of diagnosis and before definitive surgery']","['contralateral prophylactic mastectomy', 'rapid genetic counseling and testing vs. usual care', 'contralateral prophylactic mastectomy (CPM']","['rate of CPM', 'cancer-specific intrusive thoughts']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1705768'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}, {'cui': 'C0392412', 'cui_str': 'cpm'}]","[{'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts (finding)'}]",,0.0195151,"Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM.
CONCLUSION


","[{'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tynan', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Beth N', 'Initials': 'BN', 'LastName': 'Peshkin', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Heiddis B', 'Initials': 'HB', 'LastName': 'Valdimarsdottir', 'Affiliation': 'Icahn School of Medicine At Mount Sinai, Department of Population Health Science and Policy, Center for Behavioral Oncology, New York, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Nusbaum', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hooker', 'Affiliation': 'Concert Genetics, Inc, Franklin, TN, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': ""O'Neill"", 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jandorf', 'Affiliation': 'Icahn School of Medicine At Mount Sinai, Department of Population Health Science and Policy, Center for Behavioral Oncology, New York, NY, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Kelly', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Heinzmann', 'Affiliation': 'Carol G. Simon Cancer Center, Atlantic Health Systems, Summit, NJ, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Poggi', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Schwartz', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer, Georgetown University, Washington, DC, USA. schwartm@georgetown.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-019-05515-2']
906,31375279,Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension.,"BACKGROUND


It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy.
OBJECTIVE


To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy.
DESIGN, SETTING, AND PARTICIPANTS


This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion.
INTERVENTION


A total of 126 patients received adjuvant radiotherapy at 66.6Gy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints.
RESULTS AND LIMITATIONS


The median follow-up time for patients who were alive when the follow-up ended was 9.3yr in the adjuvant group and 8.6yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p<0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p=0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p=0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients.
CONCLUSIONS


Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
PATIENT SUMMARY


Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone.",2019,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","['250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion', '43 patients with biochemical recurrence in the observation group, 37 patients received', 'patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy', 'Prostate Cancer Patients with Positive Margins or Extracapsular Extension', '126 patients received', 'patients with positive margins or extracapsular extension']","['Radical Prostatectomy Versus Radical Prostatectomy Alone', 'Adjuvant radiotherapy', 'radical prostatectomy alone', 'adjuvant radiotherapy', 'Radiotherapy', 'Adjuvant Radiotherapy', 'salvage radiotherapy']","['Overall survival, cancer-specific survival, local recurrence, and adverse events', 'overall survival', '10-yr survival for biochemical recurrence', 'effectiveness and tolerability', 'grade 3 adverse events', 'tolerated and prolongs biochemical recurrence-free survival', 'biochemical recurrence-free survival', 'median follow-up time']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0036628', 'cui_str': 'Seminal Vesicles'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",250.0,0.344689,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","[{'ForeName': 'Greetta', 'Initials': 'G', 'LastName': 'Hackman', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Kouri', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Joensuu', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Luukkaala', 'Affiliation': 'Research, Development and Innovation Center, Tampere University Hospital and Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Salonen', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Isotalo', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Pétas', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Niilo', 'Initials': 'N', 'LastName': 'Hendolin', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Boström', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Aaltomaa', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lehtoranta', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Hellström', 'Affiliation': 'Department of Urology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Korpela', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Finnish Cancer Registry-Institute for Statistical and Epidemiological Cancer Research, Helsinki, Finland; Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Akseli', 'Initials': 'A', 'LastName': 'Hemminki', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland; Cancer Gene Therapy Group, Translational Immunology Research Program, University of Helsinki, Helsinki, Finland. Electronic address: akseli.hemminki@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.07.001']
907,32088134,"Accuracy, inter-observer and intra-observer reliability in topography assessment of multifocal contact lens centration.","PURPOSE


To evaluate the accuracy and reliability (inter and intra-observer) of a method to assess multifocal contact lenses (MCLs) centration using a corneal topography unit.
METHOD


Daily-disposable MCLs (Fusion 1 day Presbyo) were fitted on both eyes of the subjects. For each lens fit a slit lamp digital picture and videokeratograph image were taken in a rapid but randomised sequence. Photo-editing software was used to assess the position of the MCL centre with respect to pupil centre as taken from the slit lamp photograph. The position of the MCL centre was automatically detected as the point of maximum curvature from the videokeratography. Three further manual and qualitative procedures to detect MCL centre, comparing a template of CLs optic zones to the videokeratographic image were performed by 4 practitioners using 3 different algorithms to represent the topographic map. Each manual reading was repeated 3 times.
RESULTS


Twenty-two subjects (11 males) aged 22.8 ± 1.9 years (range 20.8-27.0 years) were recruited. The accuracy of the 4 topographic assessments in determining the centre coordinates of the MCL with respect to SL assessment was good: no differences were found in the left eyes and although in the right eyes a more temporal and superior position of MCLs was determined (paired t-test, p < 0.05) the difference was clinically negligible (0.16 ± 0.36 mm horizontally, 0.23 ± 0.48 vertically). Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments. Intra-class correlation coefficient was calculated among the 3 readings for each manual procedure and was very good (between 0.75 and 0.98) in 3 practitioners and moderate (between 0.49 and 0.92) in the fourth.
CONCLUSIONS


The assessment of MCL centration by performing corneal topography over the MCL is an accurate method. Furthermore, inter and intra-practitioner reliability showed by manual procedures appeared very good.",2020,Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments.,['Twenty-two subjects (11 males) aged 22.8 ± 1.9 years (range 20.8-27.0 years) were recruited'],"['multifocal contact lenses (MCLs) centration', 'Daily-disposable MCLs']","['temporal and superior position of MCLs', 'Intra-class correlation coefficient', 'Accuracy, inter-observer and intra-observer reliability']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",22.0,0.0130263,Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments.,"[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Zeri', 'Affiliation': 'University of Milano Bicocca, Department of Materials Science, via R. Cozzi 55, I-20125 Milan, Italy; University of Milano Bicocca, COMiB Research Centre in Optics and Optometry, via R. Cozzi 55, I-20125 Milan, Italy; School of Life and Health Sciences, Aston University, Birmingham, UK. Electronic address: fabrizio.zeri@unimib.it.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Di Vizio', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guida', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Rotondi', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tavazzi', 'Affiliation': 'University of Milano Bicocca, Department of Materials Science, via R. Cozzi 55, I-20125 Milan, Italy; University of Milano Bicocca, COMiB Research Centre in Optics and Optometry, via R. Cozzi 55, I-20125 Milan, Italy.'}, {'ForeName': 'Shehzad A', 'Initials': 'SA', 'LastName': 'Naroo', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.008']
908,32108232,PATCH trial: explanatory analyses.,,2020,,[],['Platelet transfusion'],[],[],"[{'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}]",[],,,,"[{'ForeName': 'M Irem', 'Initials': 'MI', 'LastName': 'Baharoglu', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centres, location Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Université Lille, INSERM, Centre Hospitalier Universitaire (CHU) Lille, U1172, LilNCog, Lille Neuroscience & Cognition, Lille, France.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Koopman', 'Affiliation': 'Department of Transfusion Medicine, Sanquin Bloodbank, Amsterdam, The Netherlands.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Manson', 'Affiliation': 'Department of Transfusion Medicine, Scottish National Blood Transfusion Service, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Susen', 'Affiliation': 'European Genomic Institute for Diabetes (EGID), INSERM U1011, Université de Lille, Lille, France.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'Department of Radiology and Nuclear Medicine, and.'}, {'ForeName': 'Ludo F', 'Initials': 'LF', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, and.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, and.'}, {'ForeName': 'Yvo B', 'Initials': 'YB', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centres, location Academic Medical Centre, Amsterdam, The Netherlands.'}]",Blood,['10.1182/blood.2019003298']
909,32434709,Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.,"BACKGROUND


Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment.
AIM


To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods.
METHODS


The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics.
MAIN OUTCOME MEASURES


The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method.
RESULTS


The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60).
CLINICAL IMPLICATIONS


Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates.
STRENGTH & LIMITATIONS


Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size.
CONCLUSION


The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311.",2020,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).",['212 women suffering from provoked vestibulodynia'],"['conventional methods (eg, posters, leaflets, business cards, newspaper ads', 'topical lidocaine']","['cost-effectiveness (cost per enrolled participant), and retention rate', 'Recruitment efficiency', 'health professional referrals', 'Efficiency and Cost', 'retention rate', 'efficiency, effectiveness, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",212.0,0.330363,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Benoit-Piau', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, and Research Center, Institut universitaire de gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Soleil', 'Initials': 'MS', 'LastName': 'Carroll', 'Affiliation': ""Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, and Research Center, Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': 'Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.005']
910,30789855,Antioxidants for Pancreatic Functions in Chronic Pancreatitis: A Double-blind Randomized Placebo-controlled Pilot Study.,"BACKGROUND


Antioxidants (AO) supplementation in chronic pancreatitis (CP) has been evaluated for pain. But it is not clear whether AO in CP have an effect on pancreatic functions and other clinical outcomes. We evaluated effect of AO on endocrine function in CP.
MATERIALS AND METHODS


Double-blind placebo (PL)-controlled randomized pilot study on 107 patients with CP assigned to receive daily combined AO or PL for 6 months. Primary outcome was: improvement in endocrine function (Homeostasis Model Assessment-Insulin Resistance). Secondary outcome measures were: improvement in C-peptide, Qualitative Insulin Sensitivity Check Index, exocrine pancreatic function (fecal elastase), surrogate markers of fibrosis (platelet-derived growth factor BB, transforming growth factor-β1, α-smooth muscle actin), quality of life (QOL), pain, nutritional status, markers of oxidative stress (OS), AO status, and inflammation.
RESULTS


There was an increase in levels of serum selenium (107.2±26.9 to 109.7±26.9 vs. 104.1±28.6 to 124.0±33.6 μg/L, P=0.022) and serum vitamin E [0.58 (range, 0.27-3.22) to 0.66 (range, 0.34-1.98) vs. 0.63 (range, 0.28-1.73) to 1.09 (range, 0.25-2.91) mg/dL, P=0.001] in the AO than the PL group. However, no significant differences were observed between groups in any of the primary or secondary outcome measures.
CONCLUSIONS


Supplementation with AO to patients with CP causes a sustained increase in blood levels of AO; however, it has no addition benefit over PL on endocrine and exocrine functions, markers of fibrosis, OS and inflammation, nutritional status, pain and QOL. Further larger studies with adequate sample size are required.",2020,"There was an increase in levels of serum selenium (107.2±26.9 to 109.7±26.9 vs. 104.1±28.6 to 124.0±33.6 μg/L, P=0.022) and serum vitamin E","['chronic pancreatitis (CP', 'Chronic Pancreatitis', '107 patients with CP assigned to']","['placebo', 'Antioxidants (AO) supplementation', 'Placebo', 'receive daily combined AO or PL', 'Antioxidants']","['serum vitamin E', 'blood levels of AO', 'improvement in C-peptide, Qualitative Insulin Sensitivity Check Index, exocrine pancreatic function (fecal elastase), surrogate markers of fibrosis (platelet-derived growth factor BB, transforming growth factor-β1, α-smooth muscle actin), quality of life (QOL), pain, nutritional status, markers of oxidative stress (OS), AO status, and inflammation', 'levels of serum selenium', 'endocrine and exocrine functions, markers of fibrosis, OS and inflammation, nutritional status, pain and QOL', 'improvement in endocrine function (Homeostasis Model Assessment-Insulin Resistance']","[{'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C0030306', 'cui_str': 'Elastase'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C1267092', 'cui_str': 'Muscle, Involuntary'}, {'cui': 'C0001271', 'cui_str': 'Actins'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0858170', 'cui_str': 'Serum selenium'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",107.0,0.327215,"There was an increase in levels of serum selenium (107.2±26.9 to 109.7±26.9 vs. 104.1±28.6 to 124.0±33.6 μg/L, P=0.022) and serum vitamin E","[{'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology and Human Nutrition Unit.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Ahuja', 'Affiliation': 'Department of Gastroenterology and Human Nutrition Unit.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Sachdev', 'Affiliation': 'Department of Gastroenterology and Human Nutrition Unit.'}, {'ForeName': 'Ashish D', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Goswami', 'Affiliation': 'Endocrinology & Metabolism.'}, {'ForeName': 'Lakshmy', 'Initials': 'L', 'LastName': 'Ramakrishnan', 'Affiliation': 'Cardiac-biochemistry, All India Institute of Medical Sciences.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Centre for Promotion of Nutrition Research and Training Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Saraya', 'Affiliation': 'Department of Gastroenterology and Human Nutrition Unit.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001178']
911,32434492,Loneliness as a predictor of outcomes in mental disorders among people who have experienced a mental health crisis: a 4-month prospective study.,"BACKGROUND


Loneliness has not until recently been a prominent focus in research on outcomes of mental illness. The aim of this study was to determine whether loneliness at baseline predicts poor outcomes at 4-month follow-up for individuals who have experienced mental health crises. The outcomes in this study included overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life.
METHODS


Our study reports a secondary analysis of data from a randomised controlled trial. The sample (n = 399) was taken from patients who received treatment from community crisis services. Respondents (n = 310) completed the follow-up measurement 4 months after baseline. Loneliness at baseline was assessed using an eight-item UCLA Loneliness Scale. The four mental health outcomes were measured at both baseline and follow-up. Two scales (or part thereof) assessed objective social isolation and neighbourhood social capital at baseline. Regression analyses were conducted to investigate longitudinal associations between loneliness at baseline and mental health outcomes at follow-up.
RESULTS


Loneliness at baseline was associated with all four mental health outcomes at 4-month follow-up, adjusting for psychosocial, socio-demographic and clinical characteristics. A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively. Loneliness was a better predictor of clinical outcomes than objective social isolation and social capital, even though the associations with clinical outcomes were reduced and no longer statistically significant following adjustment for their baseline values. A significant association with quality of life persisted after adjustment for its baseline score.
CONCLUSIONS


Greater loneliness at baseline predicted poorer health-related quality of life at follow-up. There were cross-sectional associations between loneliness and clinical outcomes, but their longitudinal relationship cannot be confirmed. Further research is needed to clearly establish their underpinning pathways. Reducing loneliness may be a promising target to improve recovery for mental health community crisis service users.",2020,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","['people who have experienced a mental health crisis', 'individuals who have experienced mental health crises', 'mental health community crisis service users']",[],"['quality of life', 'self-rated recovery score and health-related quality of life score', 'overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life', 'health-related quality of life', 'overall symptom severity score and affective symptoms score', 'loneliness score', 'objective social isolation and neighbourhood social capital']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",,0.216986,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. jingyi.wang.13@ucl.ac.uk.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, UCL Medical School, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Mann', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.johnson@ucl.ac.uk.'}]",BMC psychiatry,['10.1186/s12888-020-02665-2']
912,31309968,Reliability and Validity of Ratings of Perceived Difficulty During Performance of Static Standing Balance Exercises.,"BACKGROUND


Standardized instruments for measuring the intensity of balance exercises in clinical environments are lacking.
OBJECTIVE


The objective of this study was to develop a method for quantifying the perceived intensity of standing balance exercises.
DESIGN


A test-retest study design was used, with repeated evaluations within the same visit and between visits 1 week later.
METHODS


Sixty-two participants who were healthy and 18 to 85 years old (with a mean age of 55 years [SD = 20 years]; 50% women) were enrolled. On each of 2 visits, they performed 2 sets of 24 randomized static standing exercises consisting of combinations of the following factors: surface, vision, stance, and head movement. Postural sway was measured with an inertial measurement unit, and ratings of perceived difficulty (RPD) were recorded using numerical and qualitative scales. The RPD scales were validated against the quantitative sway measures using a general linear model approach. The test-retest reliability of the RPD scales was examined using a weighted kappa coefficient.
RESULTS


Both RPD scales were associated with postural sway measures with correlation coefficients > 0.6 for the whole sample. The test-retest reliability of the ratings varied considerably across the different balance exercises, and the highest weighted kappa values occurred for RPD scores on the numerical scale within the second visit, as moderate agreement was achieved in 18 of the 24 exercises.
LIMITATIONS


The limitations are that the RPD scales need to be validated for other types of balance exercises and in individuals with balance disorders.
CONCLUSIONS


The RPD scores correlated with the magnitude of postural sway, suggesting that they can be used as a proxy measure of perceived intensity of balance exercises.",2019,"The test-retest reliability of the ratings varied considerably across the different balance exercises, and the highest weighted kappa values occurred for RPD scores on the numerical scale within the second visit, as moderate agreement was achieved in 18 of the 24 exercises.
","['Sixty-two participants who were healthy and 18 to 85 years old (with a mean age of 55 years [SD = 20 years]; 50% women) were enrolled', 'individuals with balance disorders']",['Static Standing Balance Exercises'],"['inertial measurement unit, and ratings of perceived difficulty (RPD', 'RPD scales', 'RPD scores', 'Postural sway']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",62.0,0.0394957,"The test-retest reliability of the ratings varied considerably across the different balance exercises, and the highest weighted kappa values occurred for RPD scores on the numerical scale within the second visit, as moderate agreement was achieved in 18 of the 24 exercises.
","[{'ForeName': 'Saud F', 'Initials': 'SF', 'LastName': 'Alsubaie', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Prince Sattam Bin Abdulaziz University, Alkharj 16278, Saudi Arabia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Whitney', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Furman', 'Affiliation': 'Department of Otolaryngology, University of Pittsburgh.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Marchetti', 'Affiliation': 'Department of Physical Therapy, Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Sienko', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brooke N', 'Initials': 'BN', 'LastName': 'Klatt', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Sparto', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Physical therapy,['10.1093/ptj/pzz091']
913,32008619,Effect of Simulation Training on Cognitive Performance Using Transesophageal Echocardiography.,"Simulation is used in anesthesia training to reinforce didactic learning. The authors hypothesized that knowledge acquisition in the use of transesophageal echocardiography (TEE) could be accomplished better through the use of a simulator than with online or web-based learning. A total of 71 student registered nurse anesthetists were randomly assigned to either web-based or simulator-based TEE training. Using the same rubric, each group was instructed to use 11 views to identify 12 different cardiac structures. In addition, 15 cardiac abnormalities (""pathologies"") were identified through either the simulator or a web-based link. The effect of the interventions were measured using a video-based (ExamSoft) assessment to validate improved knowledge of cardiac structures, recognition of ultrasonographic views, and identification of cardiac pathology. Although both groups demonstrated significant improvement, students who trained with the simulator scored higher than the web-based group, 69.4 vs 42.3 (P < .01). Scores were compared using the Mann-Whitney test and 2-tailed t tests. Implementation of TEE training using either modality improved TEE-related knowledge, and both are recommended as a supplement to conventional didactic training.",2020,"Although both groups demonstrated significant improvement, students who trained with the simulator scored higher than the web-based group, 69.4 vs 42.3 (P < .01).",['A total of 71 student registered nurse anesthetists'],"['web-based or simulator-based TEE training', 'transesophageal echocardiography (TEE', 'Simulation Training', 'TEE training']","['knowledge of cardiac structures, recognition of ultrasonographic views, and identification of cardiac pathology', 'Cognitive Performance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0473161', 'cui_str': 'Anesthetist'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",71.0,0.031959,"Although both groups demonstrated significant improvement, students who trained with the simulator scored higher than the web-based group, 69.4 vs 42.3 (P < .01).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Shields', 'Affiliation': 'is a Certified Registered Nurse Anesthetist at the Vanderbilt Heart and Vascular Institute, Nashville Tennessee, and assistant program director at Middle Tennessee School of Anesthesia, Madison, Tennessee.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Gentry', 'Affiliation': 'is a Certified Registered Nurse Anesthetist and program director at Middle Tennessee School of Anesthesia.'}]",AANA journal,[]
914,31512716,Sevoflurane- and propofol-based regimens show comparable effect on oxygenation in patients undergoing cardiac valve replacement with cardiopulmonary bypass.,"BACKGROUND


Our study aimed to compare the effects of Sevoflurane- and propofol-based anaesthetic regimens on oxygenation during the early period of cardiopulmonary bypass (CPB) in patients undergoing cardiac valve-replacement surgery.
METHODS


Patients undergoing mechanical mitral, aortic or double valve replacement were enrolled and randomly divided into two groups: the sevoflurane-based anaesthetic regimen group consisted of patients who received 1-3% sevoflurane inhalation during anaesthesia maintenance and the propofol-based anaesthetic regimen group consisted of patients who received 6-10 mg/kg/h of propofol infusion during anaesthesia maintenance. The partial pressure of oxygen/fraction of inspired oxygen (PaO 2 /FiO 2 ), respiratory mechanics and haemodynamics were recorded during CPB.
RESULTS


Forty-two patients met the eligibility criteria for the study. The groups did not differ in terms of clinical and demographic characteristics, and pre- and intra-operative features. Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients. There were no differences in PaO 2 /FiO 2 , respiratory mechanics and haemodynamics between the sevoflurane and propofol groups.
CONCLUSIONS


In patients undergoing cardiac valve replacement with CPB, lung injury was mild, and sevoflurane- and propofol-based anaesthetic regimens showed similar effect on oxygenation, respiratory mechanics and haemodynamics during the early stage of CPB.",2020,Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients.,"['Forty-two patients met the eligibility criteria for the study', 'patients undergoing cardiac valve-replacement surgery', 'Patients undergoing mechanical mitral, aortic or double valve replacement', 'patients undergoing cardiac valve replacement with cardiopulmonary bypass', 'patients undergoing cardiac valve replacement with CPB, lung injury']","['cardiopulmonary bypass (CPB', 'Sevoflurane- and propofol', 'propofol-based anaesthetic regimen group consisted of patients who received 6-10 mg/kg/h of propofol infusion', 'sevoflurane-based anaesthetic regimen group consisted of patients who received 1-3% sevoflurane inhalation', 'sevoflurane', 'Sevoflurane- and propofol-based anaesthetic regimens']","['clinical and demographic characteristics, and pre- and intra-operative features', 'oxygenation, respiratory mechanics and haemodynamics', 'partial pressure of oxygen/fraction of inspired oxygen (PaO 2 /FiO 2 ), respiratory mechanics and haemodynamics', 'PaO 2 /FiO 2 , respiratory mechanics and haemodynamics']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0190170', 'cui_str': 'Double valve replacement (procedure)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]",42.0,0.0543182,Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients.,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yunxia', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China. Email: 769574913@qq.com.'}, {'ForeName': 'Guizhi', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China. Email: du_guizhi@yahoo.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-050']
915,32045025,Assessing the impact of a family nurse-led intervention on young mothers' references to internal states.,"A mother's propensity to refer to internal states during mother-child interactions is important for her child's developing social understanding. However, adolescent mothers are less likely to reference internal states when interacting with their children. We investigated whether young mothers' references to internal states are promoted by the Family Nurse Partnership (FNP) intervention, an intensive home-visiting programme designed to support adolescent mothers in England. We also investigated family, maternal, and child factors associated with young mothers' references to inner states during interactions with their children. Adolescent mothers (n = 483, aged ≤ 19 years when recruited in pregnancy) and their children participated in an observational substudy of a randomized controlled trial investigating the impact of FNP compared to usual care. Mother-child dyads were video-recorded during free play, and mothers' speech was coded for use of internal state language (references to cognitions, desires, emotions, intentions, preferences, physiology, and perception). We found no differences in mothers' use of internal state language between the FNP and usual care groups. A sample-wide investigation identified that other features of mothers' language and relationship status with the child's father were associated with internal state language use. Findings are discussed with reference to targeted interventions and implications for future research.",2020,We found no differences in mothers' use of internal state language between the FNP and usual care groups.,"['adolescent mothers in England', 'Adolescent mothers (n\xa0=\xa0483, aged ≤ 19 years when recruited in pregnancy) and their children participated', 'adolescent mothers']","['Family Nurse Partnership (FNP) intervention', 'family nurse-led intervention', 'FNP']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],483.0,0.0187136,We found no differences in mothers' use of internal state language between the FNP and usual care groups.,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Paine', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lugg-Widger', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cerith S', 'Initials': 'CS', 'LastName': 'Waters', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}]",Infant mental health journal,['10.1002/imhj.21849']
916,32435762,Protocol for two-arm pragmatic cluster randomized hybrid implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation.,"Background


COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.
Methods and design


Twenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.
Discussions


This study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.
Trial registration


Name of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019.",2020,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"['Twenty hospitals with low baseline rates of NIV use', 'patients with COPD requiring ventilatory support', 'patients with severe COPD exacerbation', 'Patients with acute respiratory failure due to severe COPD exacerbation', 'ClinicalTrials.govTrial registration number', 'patients with COPD in hospitals enrolled in the two arms', 'Trial registration\n\n\nName of registry']","['invasive (IMV) or noninvasive mechanical ventilation (NIV', 'OLE', 'educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery']",['hospital rate of NIV use'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",20.0,0.289848,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"[{'ForeName': 'Mihaela S', 'Initials': 'MS', 'LastName': 'Stefan', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Penelope S', 'Initials': 'PS', 'LastName': 'Pekow', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Shea', 'Affiliation': '4Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC USA.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hughes', 'Affiliation': '5College of Applied Health Science, University of Illinois at Chicago, Chicago, IL USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hill', 'Affiliation': '6Division of Pulmonary and Critical Care Medicine, Tufts University School of Medicine, Boston, MA USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': '7Division of Pulmonary and Critical Care, Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Lindenauer', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}]",Implementation science communications,['10.1186/s43058-020-00028-2']
917,32435929,Effectiveness of the clinical decision support tool ESR eGUIDE for teaching medical students the appropriate selection of imaging tests: randomized cross-over evaluation.,"OBJECTIVES


To evaluate ESR eGUIDE-the European Society of Radiology (ESR) e-Learning tool for appropriate use of diagnostic imaging modalities-for learning purposes in different clinical scenarios.
METHODS


This anonymized evaluation was performed after approval of ESR Education on Demand leadership. Forty clinical scenarios were developed in which at least one imaging modality was clinically most appropriate, and the scenarios were divided into sets 1 and 2. These sets were provided to medical students randomly assigned to group A or B to select the most appropriate imaging test for each scenario. Statistical comparisons were made within and across groups.
RESULTS


Overall, 40 medical students participated, and 31 medical students (78%) answered both sets. The number of correctly chosen imaging methods per set in these 31 paired samples was significantly higher when answered with versus without use of ESR eGUIDE (13.7 ± 2.6 questions vs. 12.1 ± 3.2, p = 0.012). Among the students in group A, who first answered set 1 without ESR eGUIDE (11.1 ± 3.2), there was significant improvement when set 2 was answered with ESR eGUIDE (14.3 ± 2.5, p = 0.013). The number of correct answers in group B did not drop when set 2 was answered without ESR eGUIDE (12.4 ± 2.6) after having answered set 1 first with ESR eGUIDE (13.0 ± 2.7, p = 0.66).
CONCLUSION


The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
KEY POINTS


• ESR eGUIDE improved the number of appropriately selected imaging modalities among medical students. • This improvement was also seen in the group of students which first selected imaging tests without ESR eGUIDE. • In the student group which used ESR eGUIDE first, appropriate selection remained stable even without the teaching tool.",2020,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","['40 medical students participated, and 31 medical students (78%) answered both sets', 'teaching medical students']",[],['number of correct answers'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0195978,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",European radiology,['10.1007/s00330-020-06942-2']
918,32070386,Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial: Dutch results.,"BACKGROUND


The STAR-TReC trial is an international multi-center, randomized, phase II study assessing the feasibility of short-course radiotherapy or long-course chemoradiotherapy as an alternative to total mesorectal excision surgery. A new target volume is used for both (chemo)radiotherapy arms which includes only the mesorectum. The treatment planning QA revealed substantial variation in dose to organs at risk (OAR) between centers. Therefore, the aim of this study was to determine the treatment plan variability in terms of dose to OAR and assess the effect of a national study group meeting on the quality and variability of treatment plans for mesorectum-only planning for rectal cancer.
METHODS


Eight centers produced 25 × 2 Gy treatment plans for five cases. The OAR were the bowel cavity, bladder and femoral heads. A study group meeting for the participating centers was organized to discuss the planning results. At the meeting, the values of the treatment plan DVH parameters were distributed among centers so that results could be compared. Subsequently, the centers were invited to perform replanning if they considered this to be necessary.
RESULTS


All treatment plans, both initial planning and replanning, fulfilled the target constraints. Dose to OAR varied considerably for the initial planning, especially for dose levels below 20 Gy, indicating that there was room for trade-offs between the defined OAR. Five centers performed replanning for all cases. One center did not perform replanning at all and two centers performed replanning on two and three cases, respectively. On average, replanning reduced the bowel cavity V20Gy by 12.6%, bowel cavity V10Gy by 22.0%, bladder V35Gy by 14.7% and bladder V10Gy by 10.8%. In 26/30 replanned cases the V10Gy of both the bowel cavity and bladder was lower, indicating an overall lower dose to these OAR instead of a different trade-off. In addition, the bowel cavity V10Gy and V20Gy showed more similarity between centers.
CONCLUSIONS


Dose to OAR varied considerably between centers, especially for dose levels below 20 Gy. The study group meeting and the distribution of the initial planning results among centers resulted in lower dose to the defined OAR and reduced variability between centers after replanning.
TRIAL REGISTRATION


The STAR-TReC trial, ClinicalTrials.gov Identifier: NCT02945566. Registered 26 October 2016, https://clinicaltrials.gov/ct2/show/NCT02945566).",2020,"On average, replanning reduced the bowel cavity V20Gy by 12.6%, bowel cavity V10Gy by 22.0%, bladder V35Gy by 14.7% and bladder V10Gy by 10.8%.",['Eight centers produced 25\u2009×\u20092 Gy treatment plans for five cases'],['short-course radiotherapy or long-course chemoradiotherapy'],"['bowel cavity V20Gy', 'bowel cavity and bladder', 'Radiotherapy quality assurance', 'bladder V35Gy', 'bowel cavity V10Gy']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0500232,"On average, replanning reduced the bowel cavity V20Gy by 12.6%, bowel cavity V10Gy by 22.0%, bladder V35Gy by 14.7% and bladder V10Gy by 10.8%.","[{'ForeName': 'Roy P J', 'Initials': 'RPJ', 'LastName': 'van den Ende', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands. r.p.j.van_den_ende@lumc.nl.'}, {'ForeName': 'Femke P', 'Initials': 'FP', 'LastName': 'Peters', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Harderwijk', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Rütten', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Bouwmans', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Richard A M', 'Initials': 'RAM', 'LastName': 'Canters', 'Affiliation': 'Department of Radiation Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Georgiana', 'Initials': 'G', 'LastName': 'Stoian', 'Affiliation': 'Department of Radiation Oncology, Isala Clinics, Zwolle, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Compagner', 'Affiliation': 'Department of Radiation Oncology, Isala Clinics, Zwolle, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Rozema', 'Affiliation': 'Department of Radiation Oncology, Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'de Smet', 'Affiliation': 'Department of Radiation Oncology, Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiotherapy, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Rob H N', 'Initials': 'RHN', 'LastName': 'Tijssen', 'Affiliation': 'Department of Radiotherapy, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Theuws', 'Affiliation': 'Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Haaren', 'Affiliation': 'Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Baukelien', 'Initials': 'B', 'LastName': 'van Triest', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Eekhout', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Kerkhof', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, P.O. Box 9600 2300, RC, Leiden, the Netherlands.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01487-6']
919,15525879,Clinical significance of alendronate in postmenopausal type 2 diabetes mellitus.,"OBJECTIVES


To examine early changes in biochemical markers of bone turnover and bone mineral density (BMD) in a clinical trial of anti-resorptive agent alendronate versus alfacalcidol in postmenopausal women with type 2 diabetes mellitus.
METHODS


12 subjects (mean age; 73.1 +/- 6.3 yrs, duration of diabetes; 13.2 +/- 3.7 yrs) were administered alendronate sodium (5 mg/day) and 12 subjects (mean age; 70.7 +/- 7.8 yrs, duration of diabetes; 12.8 +/- 2.0 yrs) were administered alfacalcidol (0.5 microg/day) for 12 months. Urinary N-telopeptide cross-linked collagen type I (NTx), one of biochemical markers, and radial bone mineral density (BMD) were measured as a marker of bone turnover.
RESULTS


After 12 months, urinary NTx did not change in women with alfacalcidol treatment, however urinary NTx significantly decreased after alendronate treatment. The BMD significantly decreased by 3.33% (p<0.05) in women with alfacalcidol treatment, while the BMD did not decrease in women with alendronate treatment.
CONCLUSION


Alendronate that produces reduction in urinary NTx and inhibition of decrease in BMD may have a clinical significance to reduce the risk of bone fracture in postmenopausal type 2 diabetic women.",2004,"The BMD significantly decreased by 3.33% (p<0.05) in women with alfacalcidol treatment, while the BMD did not decrease in women with alendronate treatment.
","['postmenopausal women with type 2 diabetes mellitus', 'postmenopausal type 2 diabetes mellitus', '12 subjects (mean age', 'postmenopausal type 2 diabetic women']","['alfacalcidol', 'anti-resorptive agent alendronate', 'alendronate', 'alendronate sodium', 'Alendronate']","['bone turnover and bone mineral density (BMD', 'radial bone mineral density (BMD', 'urinary NTx', 'BMD', 'duration of diabetes', 'Urinary N-telopeptide cross-linked collagen type']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0700482', 'cui_str': 'Alendronate Sodium'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",12.0,0.0517258,"The BMD significantly decreased by 3.33% (p<0.05) in women with alfacalcidol treatment, while the BMD did not decrease in women with alendronate treatment.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Department of Adult and Geriatric Nursing, School of Health Sciences, Faculty of Medicine, Tottori University, Yonago, Japan. ikeda@grape.med.tottori-u.ac.jp'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Manabe', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Iwata', 'Affiliation': ''}]",Diabetes & metabolism,[]
920,31485965,A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.,"BACKGROUND


There is a need for new strategies to improve the success of obesity treatment within the primary care setting.
OBJECTIVE


To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care.
DESIGN


Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital.
PARTICIPANTS


From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention.
INTERVENTIONS


Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months.
MAIN MEASURES


The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss.
KEY RESULTS


Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes.
CONCLUSIONS


Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT01922934.",2019,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"['Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital', 'From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention', 'Urban Safety-Net Primary Care Clinics']",[],"['Mean percentage weight loss', 'proportion of on-treatment patients who achieved ≥\u20095% weight loss', 'proportion of intervention-eligible patients who achieved ≥\u20095% weight loss', 'weight loss']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",428.0,0.0583472,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Saxon', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. david.saxon@ucdenver.edu.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Tsai', 'Affiliation': 'Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Speer', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Heyn', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kealey', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05222-0']
921,31858264,Long-term outcome of children and adolescents with obsessive-compulsive disorder: a 7-9-year follow-up of a randomized clinical trial.,"Pediatric obsessive-compulsive disorder (OCD) is an impairing disorder frequently associated with long-term persistence. Long-term follow-up studies that investigated psychopathological trajectories after initial treatment are scarce. The present study is a 7-9-year follow-up of a randomized clinical trial (RCT) that tested the efficacy of group cognitive-behavioral therapy (CBT) and sertraline for children with OCD (n = 40), and aimed to describe long-term outcomes of pediatric OCD and identify predictors of these outcomes. Thirty-five participants who were included in the original study were recruited for follow-up evaluations. Participants underwent a comprehensive assessment of demographic and clinical characteristics comprised of the Structured Clinical Interview for DSM Disorders (SCID) and/or Kiddie-Schedule of Affective Disorders and Schizophrenia Present-Lifetime (K-SADS-PL), and the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Thirty-three participants had a complete psychiatric assessment at follow-up (mean age 21 years, SD 3.2; 65% male). At follow-up, 13 (39.4%) participants had an OCD diagnosis, 10 (30.3%) had a diagnosis of any mental disorder (excluding OCD), and 10 (30.3%) did not have any diagnosis of mental disorder. In total, 23 participants (69.7%) had at least one mental disorder (including OCD). Among those without OCD (n = 20), 60.6% had a mental disorder. The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027). Being treated with GCBT or sertraline during the original RCT did not predict OCD at follow-up. New treatment strategies should consider the role of psychopathological trajectories using a dynamic approach to combine or change interventions to enhance prognosis.",2020,"The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027).","['Participants underwent a comprehensive assessment of demographic and clinical characteristics comprised of the Structured Clinical Interview for DSM Disorders (SCID) and/or Kiddie-Schedule of Affective Disorders and Schizophrenia Present', 'children with OCD (n\u2009=\u200940', 'Pediatric obsessive-compulsive disorder (OCD', 'Thirty-five participants who were included in the original study were recruited for follow-up evaluations', 'children and adolescents with obsessive-compulsive disorder', '23 participants (69.7%) had at least one mental disorder (including OCD', 'Thirty-three participants had a complete psychiatric assessment at follow-up (mean age 21\xa0years, SD 3.2; 65% male']","['GCBT or sertraline', 'group cognitive-behavioral therapy (CBT) and sertraline']","['OCD diagnosis: YBOCS total score', 'presence of any anxiety disorder', 'global functioning', 'diagnosis of any mental disorder (excluding OCD', 'Yale-Brown Obsessive-Compulsive Scale (YBOCS', 'OCD diagnosis']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",35.0,0.0635189,"The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil. daniel.fatori@gmail.com.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Rosa Magaly Campelo Borba', 'Initials': 'RMCB', 'LastName': 'de Morais', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Fernando R', 'Initials': 'FR', 'LastName': 'Asbahr', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01457-8']
922,32433830,Preeclampsia Risk Prediction Model for Chinese Pregnant Patients With Systemic Lupus Erythematosus.,"OBJECTIVE


To screen for a high risk of preeclampsia in women with systemic lupus erythematosus (SLE).
METHODS


A total of 513 antenatal care records of pregnant patients with SLE were obtained, and the data were randomly assigned to either a development set (n = 342) or a validation set (n = 171). Preeclampsia predictors were identified with stepwise regression, and a coefficient B of each variable was used to establish a prediction model and risk scoring system. Goodness-of-fit was assessed by the Hosmer-Lemeshow and Omnibus tests, and the area under the receiver operating characteristic curve (area under the curve) was used to assess discrimination. Validation was performed using the validation set.
RESULTS


The preeclampsia incidence was 14.4% in the pregnant patients with SLE. A mean arterial pressure (MAP) ≥96.5 mm Hg (odds ratio [OR] 213.15 [95% confidence interval (95% CI) 24.39-999.99]), prepregnancy hypertension (OR 18.19 [95% CI 2.67-125.01]), a hematologic disorder (OR 4.13 [95% CI 1.03-16.67]), positive IgM anticardiolipin antibodies (aCLs) (OR 19.85 [95% CI 1.11-333.33]), serum albumin <31.5 grams/liter (OR 9.88 [95% CI 2.07-47.62]), serum uric acid ≥303 μmoles/liter (OR 5.58 [95% CI 1.40-22.22]), and 24-hour urinary protein ≥0.286 grams (OR 14.39 [95% CI 2.43-83.33]) were selected for the preeclampsia prediction model. The area under the curve was 0.975. Preeclampsia prediction model scores >4 indicated a high risk of preeclampsia. For the validation set, the preeclampsia prediction accuracy was 93.6% (sensitivity 88.5%, specificity 94.5%).
CONCLUSION


A model for predicting the risk of preeclampsia in pregnant patients with SLE was established on the basis of MAP, prepregnancy hypertension, hematologic disorders, IgM aCLs, albumin, uric acid, and 24-hour urinary protein. The model had good predictive efficiency and can help clinicians improve pregnancy outcomes in high-risk women with early interventions.",2020,"A mean arterial pressure (MAP) ≥96.5 mmHg (OR 213.15, 95% CI=24.39-999.99), prepregnancy hypertension (OR 18.19, 95% CI=2.67-125.01), a hematological disorder (OR","['women with systemic lupus erythematosus (SLE', 'high-risk women with early interventions', 'Chinese pregnant patients with systemic lupus erythematosus', 'Five hundred thirteen antenatal care records of pregnant SLE patients', 'pregnant SLE patients']",[],"['hematological disorder (OR', 'serum uric acid ≥303 μmol/L', 'prepregnancy hypertension', 'pregnancy outcomes', 'mean arterial pressure', 'PE prediction accuracy', 'PE incidence', 'positive aCL-IgM', '24-hour urinary protein ≥0.286 g (OR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",513.0,0.107083,"A mean arterial pressure (MAP) ≥96.5 mmHg (OR 213.15, 95% CI=24.39-999.99), prepregnancy hypertension (OR 18.19, 95% CI=2.67-125.01), a hematological disorder (OR","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Gynecologic Oncology, Shanghai, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Gynecologic Oncology, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Institute of Rheumatology, Shanghai, China.'}, {'ForeName': 'Sihan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Gynecologic Oncology, Shanghai, China.'}, {'ForeName': 'Jiayue', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Gynecologic Oncology, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Di', 'Affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Gynecologic Oncology, Shanghai, China.'}]",Arthritis care & research,['10.1002/acr.24265']
923,32103441,Instability in End-of-Life Care Preference Among Heart Failure Patients: Secondary Analysis of a Randomized Controlled Trial in Singapore.,"BACKGROUND


Efforts to improve quality of end-of-life (EOL) care are increasingly focused on eliciting patients' EOL preference through advance care planning (ACP). However, if patients' EOL preference changes over time and their ACP documents are not updated, these documents may no longer be valid at the time EOL decisions are made.
OBJECTIVES


To assess extent and correlates of changes in stated preference for aggressive EOL care over time.
DESIGN


Secondary analysis of data from a randomized controlled trial of a formal ACP program versus usual care in Singapore.
PATIENTS


Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4 months for up to 2 years to assess their preference for EOL care. Analytic sample included 200 patients interviewed at least twice.
RESULTS


Nearly two thirds (64%) of patients changed their preferred type of EOL care at least once. Proportion of patients changing their stated preference for type of EOL care increased with time and the change was not unidirectional. Patients who understood their prognosis correctly were less likely to change their preference from non-aggressive to aggressive EOL care (OR 0.66, p value 0.07) or to prefer aggressive EOL care (OR 0.53; p value 0.001). On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
CONCLUSION


The study provides evidence of instability in HF patients' stated EOL care preference. This undermines the value of an ACP document recorded months before EOL decisions are made unless a strategy exists for easily updating this preference.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02299180.",2020,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","['Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4\xa0months for up to 2\xa0years to assess their preference for EOL care', 'Heart Failure Patients', '200 patients interviewed at least twice']",['formal ACP program versus usual care in Singapore'],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]",[],282.0,0.0539074,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","[{'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. chetna.malhotra@duke-nus.edu.sg.'}, {'ForeName': 'Meibo', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre Singapore, 5 Hospital Drive, Singapore, 169609, Singapore.'}, {'ForeName': 'Fazlur Rehman', 'Initials': 'FR', 'LastName': 'Jaufeerally', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Filipinas G', 'Initials': 'FG', 'LastName': 'Bundoc', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-020-05740-2']
924,31498113,Impact of ticagrelor monotherapy on two-year clinical outcomes in patients with long stenting: a post hoc analysis of the GLOBAL LEADERS trial.,"AIMS


The aim of this study was to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL).
METHODS AND RESULTS


This is a post hoc analysis of the GLOBAL LEADERS trial, a prospective, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR] 0.67, 95% confidence interval [CI]: 0.49-0.90; pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR 0.99, 95% CI: 0.66-1.49; pinteraction=0.975).
CONCLUSIONS


Ticagrelor monotherapy could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.",2020,"In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975).
","['patients with Biolimus A9-eluting stent (BES', 'patients with increasing total stent length (TSL', 'patients with TSL≥ 46 mm with BES', 'Patients with Long Stenting']","['aspirin monotherapy', 'Ticagrelor Monotherapy', 'ticagrelor monotherapy', 'Ticagrelor monotherapy']","['ischemic risk', 'balance ischemic and bleeding risks', 'composite of the all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035168'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}]",,0.0743589,"In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975).
","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': ''}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': ''}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': ''}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': ''}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': ''}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': ''}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00498']
925,31498251,The Effects of Simulation-Based Advanced Life Support Education for Nursing Students.,"Advanced life support education for nursing students is very important because nurses are first responders in emergency situations. The purpose of this study was to identify the effects of simulation-based advanced life support education on nursing students' knowledge, performance, self-efficacy, and teamwork. A nonequivalent control group posttest-only design was used. Fourth-year nursing students were randomly assigned to either simulation-based Korean Advanced Life Support (n = 30) or lecture-based education (n = 30) groups. Data were analyzed using descriptive statistics and the Mann-Whitney U test. The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group. However, there was no significant difference in teamwork scores between the two groups (P = .529). The 4.5-hour simulation-based Korean Advanced Life Support education was more effective than the 4.5-hour lecture-based education for nursing students in terms of knowledge, performance, and self-efficacy. Nurse educators should adopt simulation-based advanced life support education into the curriculum for the optimal competence of nursing students.",2020,"The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group.","['nursing students', 'Nursing Students', 'Fourth-year nursing students']","['simulation-based advanced life support education', 'simulation-based Korean Advanced Life Support (n = 30) or lecture-based education', 'Simulation-Based Advanced Life Support Education']","['self-efficacy', 'scores in knowledge', ""nursing students' knowledge, performance, self-efficacy, and teamwork"", 'teamwork scores']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]",,0.0260576,"The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group.","[{'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Author Affiliations: Graduate School, Chung-Ang University, Seoul, Republic of Korea (Mr Kim); University of Miami Miller School of Medicine, FL (Dr Issenberg); and Red Cross College of Nursing, Chung-Ang University, Seoul, Republic of Korea (Dr Roh).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Issenberg', 'Affiliation': ''}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Roh', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000560']
926,31483377,Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial.,"BACKGROUND


Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.
METHODS


We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS


Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
CONCLUSIONS


A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.",2019,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus']","['deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART\u200a<\u200a6 months ago or viral load(VL)>200c/mL or no VL']","['CLS-D-HIV-risk', 'sexual behaviour', 'time CLS']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2562.0,0.322822,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver CO, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven CT United States.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, United States.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris Diderot, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica Barbosa de', 'Initials': 'MB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
927,31366601,FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome.,"The FDA-approved mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4)-directed mAb, in August 2018 for treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Regular approval was based on a randomized, open-label trial that randomized 372 such patients, with a median of 3 prior systemic therapies, to either mogamulizumab-kpkc or vorinostat. Investigator-assessed progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm, which had an estimated median PFS of 7.6 months [95% confidence interval (CI), 5.6-10.2] compared with 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (HR = 0.53; 95% CI, 0.41-0.69). The confirmed overall response rate was 28% and 5%, respectively ( P  < 0.001), based on global composite response criteria. Adverse reactions occurring in at least 20% of mogamulizumab-kpkc recipients included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often from infection. The prescribing information includes warnings for dermatologic toxicity, infusion reactions, infections, autoimmune complications, and complications of allogeneic hematopoietic stem cell transplantation, including severe and steroid-refractory graft-versus-host disease. See related commentary by Larocca et al., p. 7272 .",2019,"The confirmed overall response rate was 28% and 5%, respectively (p <0.001), based on global composite response criteria.","['Mycosis Fungoides and Sézary Syndrome', '372 such patients, with a median of 3 prior systemic therapies, to either mogamulizumab-kpkc or vorinostat', 'adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy']",[],"['rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection', 'Adverse reactions', 'overall response rate', 'Serious adverse reactions', 'Investigator-assessed progression-free survival (PFS']","[{'cui': 'C0026948', 'cui_str': 'Mycosis Fungoides'}, {'cui': 'C0036920', 'cui_str': ""Sezary's Lymphoma""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4719632', 'cui_str': 'mogamulizumab-kpkc'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]",[],"[{'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0948715'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",372.0,0.222597,"The confirmed overall response rate was 28% and 5%, respectively (p <0.001), based on global composite response criteria.","[{'ForeName': 'Yvette L', 'Initials': 'YL', 'LastName': 'Kasamon', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Yvette.Kasamon@fda.hhs.gov.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'R Angelo', 'Initials': 'RA', 'LastName': 'de Claro', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ann T', 'Initials': 'AT', 'LastName': 'Farrell', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2030']
928,31419597,Recovery of offline and online sentence processing in aphasia: Language and domain-general network neuroplasticity.,"This paper examined the effects of treatment on both offline and online sentence processing and associated neuroplasticity within sentence processing and dorsal attention networks in chronic stroke-induced agrammatic aphasia. Twenty-three neurotypical adults and 19 individuals with aphasia served as participants. Aphasic individuals were randomly assigned to receive a 12-week course of linguistically-based treatment of passive sentence production and comprehension (N = 14, treatment group) or to serve as control participants (N = 5, natural history group). Both aphasic groups performed two offline tasks at baseline and three months following (at post-testing) to assess production and comprehension of trained passive structures and untrained syntactically related and unrelated structures. The aphasic participants and a healthy age-matched group also performed an online eyetracking comprehension task and a picture-verification fMRI task, which were repeated at post-testing for the aphasic groups. Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures. Treatment also resulted in a shift toward more normal-like eye movements and a significant increase in neural activation from baseline to post-testing. Upregulation encompassed right hemisphere regions homologs of left hemisphere regions involved in both sentence processing and domain-general functions and was positively correlated with treatment gains, as measured by offline comprehension accuracy, and with changes in processing strategies during sentence comprehension, as measured by eyetracking. These findings provide compelling evidence in favor of the contribution of both networks within the right hemisphere to the restoration of normal-like sentence processing patterns in chronic aphasia.",2019,"Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures.","['Aphasic individuals', 'Twenty-three neurotypical adults and 19 individuals with aphasia served as participants', 'aphasia', 'chronic stroke-induced agrammatic aphasia']","['linguistically-based treatment of passive sentence production and comprehension (N\xa0=\xa014, treatment group) or to serve as control participants (N\xa0=\xa05, natural history group', 'online eyetracking comprehension task and a picture-verification fMRI task']","['normal-like eye movements', 'production and comprehension of both trained structures and untrained syntactically related structures', 'neural activation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033268'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0033268'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]",,0.0289431,"Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA. Electronic address: elena.barbieri@northwestern.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mack', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Chiappetta', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Europa', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Cynthia K', 'Initials': 'CK', 'LastName': 'Thompson', 'Affiliation': ""Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA; Cognitive Neurology and Alzheimer's Disease Center, Northwestern University, Chicago, IL, USA; Department of Neurology, Northwestern University, Chicago, IL, USA.""}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2019.06.015']
929,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
930,31767043,Variation in care for children undergoing the Fontan operation for hypoplastic left heart syndrome.,"BACKGROUND


The Single Ventricle Reconstruction Trial randomised neonates with hypoplastic left heart syndrome to a shunt strategy but otherwise retained standard of care. We aimed to describe centre-level practice variation at Fontan completion.
METHODS


Centre-level data are reported as median or median frequency across all centres and range of medians or frequencies across centres. Classification and regression tree analysis assessed the association of centre-level factors with length of stay and percentage of patients with prolonged pleural effusion (>7 days).
RESULTS


The median Fontan age (14 centres, 320 patients) was 3.1 years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 (-1.35 + 0.44). Extra-cardiac Fontans were performed in 79% (4-100%) of patients at the 13 centres performing this procedure; lateral tunnels were performed in 32% (3-100%) at the 11 centres performing it. Deep hypothermic circulatory arrest (nine centres) ranged from 6 to 100%. Major complications occurred in 17% (7-33%). The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion. Centres with fewer patients (<6%) with prolonged pleural effusion and fewer (<41%) complications had a shorter length of stay (<10 days; sensitivity 1.0; specificity 0.71; area under the curve 0.96). Avoiding deep hypothermic circulatory arrest and higher weight-for-age z-score were associated with a lower percentage of patients with prolonged effusions (<9.5%; sensitivity 1.0; specificity = 0.86; area under the curve 0.98).
CONCLUSIONS


Fontan perioperative practices varied widely among study centres. Strategies to decrease the duration of pleural effusion and minimise complications may decrease the length of stay. Further research regarding deep hypothermic circulatory arrest is needed to understand its association with prolonged pleural effusion.",2019,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"['The median Fontan age (14 centres, 320 patients) was 3.1\xa0years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 ', 'neonates with hypoplastic left heart syndrome', 'children undergoing the Fontan operation for hypoplastic left heart syndrome', 'patients with prolonged pleural effusion (>7\xa0days']",[],"['shorter length of stay', 'prolonged pleural effusion', 'length of stay', 'duration of pleural effusion', 'Major complications']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0190010', 'cui_str': 'Norwood Procedure, Stage III'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",320.0,0.0949982,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Eckhauser', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Van Rompay', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ram Kumar', 'Affiliation': ""Heart Institute, Children's Hospital of Los Angeles, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pizarro', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ghanayem', 'Affiliation': ""Division of Pediatric Critical Care, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burns', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Garick D', 'Initials': 'GD', 'LastName': 'Hill', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Mjaye', 'Initials': 'M', 'LastName': 'Mazwi', 'Affiliation': 'Department of Critical Care Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': 'Division of Pediatric Cardiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': 'Division of Pediatric Cardiology, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Pediatric Cardiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zampi', 'Affiliation': ""Division of Pediatric Cardiology, University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Division of Cardiovascular Surgery, Johns Hopkins University and All Children's Hospital, St. Petersburg, FL, USA.""}, {'ForeName': 'L LuAnn', 'Initials': 'LL', 'LastName': 'Minich', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology in the young,['10.1017/S1047951119002658']
931,31490431,Training Prescription Guided by Heart Rate Variability Vs. Block Periodization in Well-Trained Cyclists.,"Javaloyes, A, Sarabia, JM, Lamberts, RP, Plews, D, and Moya-Ramon, M. Training prescription guided by heart rate variability vs. block periodization in well-trained cyclists. J Strength Cond Res 34(6): 1511-1518, 2020-Predefined training programs are common place when prescribing training. Within predefined training, block periodization (BP) has emerged as a popular methodology because of its benefits. Heart rate variability (HRV) has been proposed as an effective tool for prescribing training. The aim of this study is to examine the effect of HRV-guided training against BP in road cycling. Twenty well-trained cyclists participated in this study. After a preliminary baseline period to establish their resting HRV, cyclists were divided into 2 groups: an HRV-guided group and a BP group, and they completed 8 training weeks. Cyclists completed 3 evaluations weeks, before and after each period. During the evaluation weeks, cyclists performed: (a) a graded exercise test to assess V[Combining Dot Above]O2max, peak power output (PPO), and ventilatory thresholds with their corresponding power output (VT1, VT2, WVT1, and WVT2, respectively) and (b) a 40-minute simulated time-trial (40 TT). The HRV-guided group improved V[Combining Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04). The BP group improved WVT2 (p = 0.02). Between-group fitness and performance were similar after the study. The HRV-guided training could lead to a better timing in training prescription than BP in road cycling.",2020,"Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04).","['Twenty well-trained cyclists participated in this study', 'Well-Trained Cyclists', ' 000-000']","['HRV-guided group and a BP', 'HRV-guided training against BP', 'graded exercise test to assess', 'HRV-guided group improved V[Combining', 'V[Combining', 'J Strength Cond Res XX(X']","['PPO', 'Dot Above]O2max, peak power output (PPO), and ventilatory thresholds with their corresponding power output (VT1, VT2, WVT1, and WVT2, respectively) and', 'Heart rate variability (HRV']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",40.0,0.058427,"Dot Above]O2max (p = 0.03), PPO (p = 0.01), WVT2 (p = 0.02), WVT1 (p = 0.01), and 40 TT (p = 0.04).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Javaloyes', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Sarabia', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lamberts', 'Affiliation': 'Division of Orthopaedic Surgery, Institute of Sport and Exercise Medicine (ISEM), Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Plews', 'Affiliation': 'Sport Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramon', 'Affiliation': 'Department of Sport Sciences, Sports Research Center, Miguel Hernandez University of Elche, Alicante, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003337']
932,31449880,"Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention.","AIMS


To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial.
METHODS


Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to the delayed intervention over three years (2016-2019). The intervention arm received: formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Primary outcomes included: dietary intake, dietary-related behaviors, obesity, and metabolic parameters. Child measures included: height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables. A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls. Parent measures included: height and weight, dietary intake, and related dietary psychosocial variables.
RESULTS


Of the 4239 eligible students, 3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys. The subsamples of blood draws and dietary recalls were 34% and 24%, respectively. Intervention arm baseline descriptives, clinical and dietary data for children and parents are reported.
CONCLUSION


The TX Sprouts intervention targeted primarily low-income Hispanic children and their parents; utilized an interactive gardening, nutrition, and cooking program; and measured a battery of dietary behaviors, obesity and metabolic outcomes.",2019,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","['3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys', 'Eight schools', 'enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial', '4239 eligible students']","['TX Sprouts intervention and eight schools to the delayed intervention', 'formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families']","['height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables', 'glucose, hemoglobin-A1C, and 24-hour dietary recalls', 'height and weight, dietary intake, and related dietary psychosocial variables', 'dietary intake, dietary-related behaviors, obesity, and metabolic parameters', 'blood draws and dietary recalls']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0560271', 'cui_str': 'acre (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]",,0.0246201,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","[{'ForeName': 'JaimieN', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA. Electronic address: Jaimie.davis@austin.utexas.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nikah', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'Department of Pediatrics, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Texas A&M AgriLife Extension Service, Travis County, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Van Den Berg', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Bluestein', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105834']
933,31859045,"Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trial.","PURPOSE


The aim of this trial was to determine the effects of Preoperative physiotherapy education (POPE) and Postoperative physiotherapy (POP) maintaining pulmonary function and functional capacity in children undergoing open abdominal surgery.
METHODS


A total of eight children aged, 5-17 years old posted for open abdominal surgery received POPE and POP. Spirometry, 10 m walk test (10mWT), timed up and go test (TUGT) and chest expansion were taken preoperatively and postoperatively on day one and five. Six minute walk test (6MWT), and Nine stair climbing test (9SCT) were taken preoperatively and postoperatively on day five.
RESULTS


No statistical significant difference were noted in FVC, FEV1, PEFR, FEV1/FVC Ratio, chest expansion levels and Borg scale but in TUGT, 10mWT, 6MWT and 9SCT significant difference was noted. Effect size were calculated and post hoc power analysis revealed that the power of the study is >90%.
CONCLUSION


POPE might have positive effects in preserving pulmonary function and functional capacity.
TYPE OF STUDY


Treatment study.
LEVEL OF EVIDENCE


Level II.",2020,"No statistical significant difference were noted in FVC, FEV1, PEFR, FEV1/FVC Ratio, chest expansion levels and Borg scale but in TUGT, 10mWT, 6MWT and 9SCT significant difference was noted.","['children undergoing open abdominal surgery', 'eight children aged, 5-17\u202fyears old posted for open abdominal surgery received']","['Preoperative physiotherapy education (POPE) and Postoperative physiotherapy (POP', 'POPE', 'POPE and POP']","['FVC, FEV1, PEFR, FEV1/FVC Ratio, chest expansion levels and Borg scale but in TUGT, 10mWT, 6MWT and 9SCT significant difference', 'Spirometry, 10\u202fm walk test (10mWT), timed up and go test (TUGT) and', 'Six minute walk test (6MWT), and Nine stair climbing test (9SCT']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0044577', 'cui_str': '1-POPS'}]","[{'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test (procedure)'}]",,0.0474202,"No statistical significant difference were noted in FVC, FEV1, PEFR, FEV1/FVC Ratio, chest expansion levels and Borg scale but in TUGT, 10mWT, 6MWT and 9SCT significant difference was noted.","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: neha_sharma@mmumullana.org.'}, {'ForeName': 'Balija Satya', 'Initials': 'BS', 'LastName': 'Sree', 'Affiliation': 'Department of Pediatric surgery, Maharishi Markandeshwar institute of medical science and research, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India; Department of Pediatric Surgery, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh-249203, Uttarakhand, India.'}, {'ForeName': 'Vencita Priyanka', 'Initials': 'VP', 'LastName': 'Aranha', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: vencita.peds@mmumullana.org.'}, {'ForeName': 'Asir John', 'Initials': 'AJ', 'LastName': 'Samuel', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: asirjohnsamuel@mmumullana.org.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.10.058']
934,31507095,"Sustained Long-Term Efficacy of Motivational Counseling and Text Message Reminders on Daily Sitting Time in Patients With Rheumatoid Arthritis: Long-Term Follow-up of a Randomized, Parallel-Group Trial.","OBJECTIVE


To evaluate the 18-month postintervention efficacy following a 4-month individually tailored behavioral intervention on daily sitting time in patients with rheumatoid arthritis (RA).
METHODS


In an observer-blinded randomized trial, 150 RA patients were included. During 4 months, the intervention group (n = 75) received 3 motivational counseling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior. The control group (n = 75) maintained their usual lifestyle. The primary outcome was change from baseline to 18 months postintervention in objectively measured daily sitting time (using ActivPAL). Secondary outcomes included changes in clinical patient-reported outcomes and cardiometabolic biomarkers. A mixed-effect repeated measures analysis of covariance model in the intent-to-treat population was applied.
RESULTS


At 22 months follow-up from baseline, 12 participants were lost to follow-up. Compared to baseline, sitting time in the intervention group decreased 1.10 hours/day, whereas it increased by 1.32 hours/day in the control group, a between-group difference of -2.43 hours/day (95% confidence interval [95% CI] -2.99, -1.86; P < 0.0001) favoring the intervention group. For most secondary outcomes, between-group differences favored the intervention: visual analog scale (VAS) pain -15.51 mm (95% CI -23.42, -7.60), VAS fatigue -12.30 mm (95% CI -20.71, -3.88), physical function -0.39 Health Assessment Questionnaire units (95% CI -0.53, -0.26), total cholesterol -0.86 mmoles/liter (95% CI -1.03, -0.68), triglycerides -0.26 mmoles/liter (95% CI -0.43, -0.09), and average glucose -1.15 mmoles/liter (95% CI -1.39, -0.91).
CONCLUSION


The 4-month postintervention results showed that patients in the intervention reduced their daily sitting time and improved patient-reported outcomes and total cholesterol levels compared to the control group. Eighteen months after intervention, patients in the intervention group were still significantly less sedentary than controls. Findings suggest that a behavioral approach is beneficial for promoting long-term physical activity and health in patients with RA.",2020,"Compared to baseline, sitting time in the intervention group decreased 1.10 h/day, whereas it increased by 1.32 h/day in the control group; between-group difference of -2.43 h/day (95%CI: -2.99;-1.86; p<0.0001) favoring the intervention group.","['patients with RA', 'patients with rheumatoid arthritis', '150 RA patients were included', 'patients with rheumatoid arthritis (RA']","['motivational counselling sessions and tailored text messages aimed at increasing light-intensity physical activity through reduction of sedentary behavior', 'motivational counselling and text message reminders', 'behavioral intervention']","['changes in clinical patient-reported outcomes and cardio-metabolic biomarkers', 'intervention: VAS-pain', 'daily sitting time', 'average glucose', 'sitting time', 'objectively measured daily sitting time (ActivPAL', 'total cholesterol', 'daily sitting time, improved patient-reported outcomes and total cholesterol levels', 'VAS-fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0671941,"Compared to baseline, sitting time in the intervention group decreased 1.10 h/day, whereas it increased by 1.32 h/day in the control group; between-group difference of -2.43 h/day (95%CI: -2.99;-1.86; p<0.0001) favoring the intervention group.","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Aadahl', 'Affiliation': 'Bispebjerg and Frederiksberg Hospitals and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Merete L', 'Initials': 'ML', 'LastName': 'Hetland', 'Affiliation': 'The DANBIO Registry, Rigshospitalet, Glostrup, and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Løppenthin', 'Affiliation': 'Rigshospitalet, Glostrup, and The Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Midtgaard', 'Affiliation': 'University of Copenhagen and Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Nielsen', 'Affiliation': 'Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Rigshospitalet, Glostrup, and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Jennum', 'Affiliation': 'University of Copenhagen and Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bente A', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Rigshospitalet, Glostrup, and University of Copenhagen, Copenhagen, Denmark.'}]",Arthritis care & research,['10.1002/acr.24060']
935,15223975,Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial.,"OBJECTIVES


In order to prevent abnormalities of fetal growth still characterizing pregnancies complicated by Gestational Diabetes (GDM), in the present study we evaluated a therapeutic strategy for GDM based on ultrasound (US) measurement of fetal insulin-sensitive tissues.
METHODS


All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to conventional (C) or modified (M) management. In C the glycemic target (GT) was fixed at 90 fasting/120 post-prandial mg/dl; in M GT varied, according to US measurement of the Abdominal Circumference (AC) centile performed every 2 weeks: 80/100 if AC > or =75th, 100/140 if AC<75th. Therapy was tailored to mean fasting (FG) and postprandial glycemia (PPG).
RESULTS


Globally, 229 women completed the study, 78 in C, 151 in M. Use of insulin was 16.7% in C, 30.4% in M (total groups), significantly more frequent in M than in C (59.7% vs 15.4%) when considering only women with AC > or =75th c. Mean metabolic data were similar in the 2 groups, but in M a tightly-optimized subgroup, resulting from the lowering of GT due to AC > or =75th, coexisted with a less-controlled one, whose higher GT was justified by AC<75th. Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
CONCLUSIONS


Our data show the value of a flexible US-based approach to the treatment of GDM. This model does not necessarily involve a generalized aggressive treatment, allowing to concentrate therapeutical efforts on a small subgroup of women showing indirect US evidence of fetal hyperinsulinization. Such a selective approach allowed to obtain a near-normalization of fetal growth, with clear advantages on global pregnancy outcome.",2004,"Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
","['All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to', '229 women completed the study, 78 in C, 151 in M. Use of insulin was 16.7% in C, 30.4% in M (total groups']",['conventional (C) or modified (M) management'],"['Macrosomia', 'Pregnancy outcome', 'Mean metabolic data', 'mean fasting (FG) and postprandial glycemia (PPG', 'rate of LGA', 'SGA']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}]",229.0,0.0384945,"Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bonomo', 'Affiliation': ""Diabetes Unit, Interdisciplinary Diabetes and Pregnancy Center, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. diabetologia@ospedaleniguarda.it""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Pisoni', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Faden', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mion', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Taricco', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nobile de Santis', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Radaelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Solerte', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70114-3']
936,31466022,Comparison of posterior subthalamic area deep brain stimulation for tremor using conventional landmarks versus directly targeting the dentatorubrothalamic tract with tractography.,"OBJECTIVE


To compare posterior subthalamic area deep brain stimulation (PSA-DBS) performed in the conventional manner against diffusion tensor imaging and tractography (DTIT)-guided lead implantation into the dentatorubrothalamic tract (DRTT).
PATIENTS AND METHODS


Double-blind, randomised study involving 34 patients with either tremor-dominant Parkinson's disease or essential tremor. Patients were randomised to Group A (DBS leads inserted using conventional landmarks) or Group B (leads guided into the DRTT using DTIT). Tremor (Fahn-Tolosa-Marin) and quality-of-life (PDQ-39) scores were evaluated 0-, 6-, 12-, 36- and 60-months after surgery.
RESULTS


PSA-DBS resulted in marked tremor reduction in both groups. However, Group B patients had significantly better arm tremor control (especially control of intention tremor), increased mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths compared to Group A patients. The better outcomes were sustained for up to 60-months from surgery. The active contacts of Group B patients were consistently closer to the centre of the DRTT than in Group A. Speech problems were more common in Group A patients.
CONCLUSION


DTIT-guided lead placement results in better and more stable tremor control and fewer adverse effects compared to lead placement in the conventional manner. This is because DTIT-guidance allows closer and more consistent placement of leads to the centre of the DRTT than conventional methods.",2019,"However, Group B patients had significantly better arm tremor control (especially control of intention tremor), increased mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths compared to Group A patients.","[""34 patients with either tremor-dominant Parkinson's disease or essential tremor""]","['posterior subthalamic area deep brain stimulation (PSA-DBS', 'posterior subthalamic area deep brain stimulation', 'conventional manner against diffusion tensor imaging and tractography (DTIT)-guided lead implantation', 'DBS leads inserted using conventional landmarks) or Group B (leads guided into the DRTT using DTIT']","['Tremor (Fahn-Tolosa-Marin) and quality-of-life (PDQ-39) scores', 'adverse effects', 'marked tremor reduction', 'mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",34.0,0.0451013,"However, Group B patients had significantly better arm tremor control (especially control of intention tremor), increased mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths compared to Group A patients.","[{'ForeName': 'Hu Liang', 'Initials': 'HL', 'LastName': 'Low', 'Affiliation': ""Department of Neurosurgery, Queen's Hospital Romford, London, UK; Department of Neurosurgery, Sunway Medical Centre, Bandar Sunway, Malaysia. Electronic address: lowhli@hotmail.com.""}, {'ForeName': 'Mohd Nasir Bin Mohd', 'Initials': 'MNBM', 'LastName': 'Ismail', 'Affiliation': 'Clinical Service, Sunway Medical Centre, Bandar Sunway, Malaysia.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Taqvi', 'Affiliation': ""Department of Neurosurgery, Queen's Hospital Romford, London, UK.""}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'Deeb', 'Affiliation': ""Department of Neurophysiology, Queen's Hospital Romford, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fuller', 'Affiliation': ""Department of Neuropsychology, Queen's Hospital Romford, London, UK.""}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Misbahuddin', 'Affiliation': ""Department of Neurology, Queen's Hospital Romford, London, UK.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2019.105466']
937,32103358,Pre-post analysis of a social capital-based exercise adherence intervention for breast cancer survivors with moderate fatigue: a randomized controlled trial.,"PURPOSE


This study assessed the effectiveness of the Better Life After Cancer: Energy, Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program for breast cancer survivors (BCS), regarding cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics.
METHODS


Forty-eight BCS with moderate or high (≥ 4) CRF participated in this randomized control trial (intervention group n = 23, control group n = 25). The intervention group participated in small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises. The control group was only given written information on exercise. A questionnaire was used to assess CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital.
RESULTS


The majority of participants had undergone surgery less than 2 years ago. After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group. Both groups showed improvements in sleep quality, depression, anxiety, and QOL.
CONCLUSION


The BLESS program decreased behavioral/severity in the CRF and increased physical activity after 12 weeks among BCS. Future research needs to evaluate whether the promising results on physical activity and behavioral fatigue observed in the short term will persist over time. Also, longer-term effects should be examined.",2020,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","['breast cancer survivors with moderate fatigue', 'breast cancer survivors (BCS', 'Forty-eight BCS with moderate or high (≥\u20094']","['CRF', 'Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program', 'social capital-based exercise adherence intervention', 'small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises']","['physical activity', 'physical activity and behavioral fatigue', 'sleep quality, depression, anxiety, and QOL', 'cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics', 'CRF behavioral/severity domain', 'behavioral/severity', 'CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",48.0,0.0337544,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yoonkyung', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Young Up', 'Initials': 'YU', 'LastName': 'Cho', 'Affiliation': 'Formerly affiliated with Yonsei University Health System, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Gihong', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Sociology, Hallym University, 1, Hallymdaehak-gil, Chuncheon-si, Gangwon-do, 24252, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea. hjihee1225@hanmail.net.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05363-7']
938,31442936,Externalizing trajectories predict elevated inflammation among adolescents exposed to early institutional rearing: A randomized clinical trial.,"BACKGROUND


There has been mounting interest in the pathophysiological relation between inflammation and psychopathology. In this paper, we examined associations between internalizing and externalizing psychopathology and inflammation in adolescents with a history of severe psychosocial deprivation and children reared in typical family contexts.
METHOD


The Bucharest Early Intervention Project is a longitudinal randomized trial of high-quality foster care as an alternative to institutional care. This report is based on 56 institutionalized children randomized to care as usual, 59 institutionalized children randomized to foster care, and 101 never institutionalized children who were recruited as an in-country comparison sample. Externalizing and internalizing behaviors were reported by parents and teachers at ages 8, 12, and 16. At age 16, C-reactive protein (CRP) was derived from blood spots in a subset of participants (n = 127). Multiple-group latent growth curve models were used to examine externalizing and internalizing trajectories and their associations with CRP.
RESULTS


Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16. In the same group of children, higher internalizing behaviors at age 8, but not the rate of change in these behaviors, also predicted higher levels of CRP. In contrast, these relations were not observed in the children assigned to foster care and never institutionalized controls.
CONCLUSIONS


Early institutional rearing is associated with a coupling of psychopathology and inflammation, whereas early placement into foster care buffers against these risks. These findings have implications for promoting healthy mental and physical development amongst institutionalized children.",2019,"Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16.","['56 institutionalized children randomized to care as usual, 59 institutionalized children randomized to foster care, and 101 never institutionalized children who were recruited as an in-country comparison sample', 'institutionalized children', 'adolescents exposed to early institutional rearing', 'adolescents with a history of severe psychosocial deprivation and children reared in typical family contexts']",[],"['externalizing behaviors', 'internalizing behaviors', 'levels of CRP', 'Externalizing and internalizing behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033962', 'cui_str': 'Psychosocial Deprivation'}, {'cui': 'C0008091', 'cui_str': 'Child Rearing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.05392,"Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16.","[{'ForeName': 'Alva', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, United States. Electronic address: alvatang@umd.edu.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA, United States; Harvard Graduate School of Education, Cambridge, MA, United States.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Slopen', 'Affiliation': 'Shool of Public Health, University of Maryland, College Park, MD, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104408']
939,32097286,Physical Activity in Healthcare Workers With Low Back Pain: Effects of the Back-FIT Randomized Trial.,"OBJECTIVE


To evaluate the effects of physical activity program in healthcare workers with low back pain (LBP).
METHODS


A group of healthcare workers participated voluntarily to a meeting about LBP and to be accepted, were randomly allocated to workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website. Both programs consisted in 7 weeks of moderate intensity exercises adapted to LBP.
RESULTS


Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
CONCLUSIONS


Regular physical exercise, at home or at the workplace among healthcare workers with LBP, represents a great opportunity to improve health and reduce disability.",2020,"RESULTS


Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
","['Healthcare Workers with Low Back Pain', 'A group of healthcare workers participated voluntarly to a meeting about LBP and to be accepted', 'healthcare workers with low back pain (LBP']","['Physical Activity program', 'workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website', 'Regular physical exercise']","['Physical Activity', 'Oswestry Disability Index']","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0600191', 'cui_str': 'Intranets'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",,0.0569118,"RESULTS


Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Bernardelli', 'Affiliation': ""Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy (Dr Bernardelli, Dr Colonna); Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Dr Vigna, Dr Nava, Dr Consonni, Dr Riboldi); National Research Centre for the Working Environment, Copenhagen, Denmark (Dr Andersen).""}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Vigna', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Nava', 'Affiliation': ''}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'De Gennaro Colonna', 'Affiliation': ''}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ''}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Riboldi', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001844']
940,31473079,Economic costs of implementing group interventions to reduce diabetes distress in adults with type 1 diabetes mellitus in the T1-REDEEM trial.,"AIMS


This study evaluated the implementation costs of two group interventions, one focused on diabetes education (KnowIt) and one focused directly on diabetes distress (OnTrack), that reduced diabetes distress and HbA1C in adults with poorly controlled type 1 diabetes (T1DM) in the T1-REDEEM trial.
METHODS


Resources used to provide interventions were enumerated using activity-based micro-costing methods. Costs were assigned to resources in 2017 US dollars. US median wage and benefit rates were used to calculate costs of staff time. Cost per unit change was calculated for diabetes distress and HbA1C.
RESULTS


For both interventions, per participant implementation costs were approximately $250 and cost per 1.0 percentage point (11 mmol/mol) change in HbA1C was $1400. Cost per unit change in diabetes distress was $364 for KnowIt and $335 for OnTrack. No statistically significant differences in costs were observed.
CONCLUSIONS


This is the first study to examine the costs of implementing interventions targeting diabetes distress in the context of T1DM. Both interventions had per participant implementation costs in the lower end of the range of previously examined diabetes self-management interventions ($219 to $5390). These inventions and their costs merit further attention because reducing diabetes distress may impact long term T1DM outcomes.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.govNCT02175732.",2019,"No statistically significant differences in costs were observed.
","['adults with type 1 diabetes mellitus', 'adults with poorly controlled type 1 diabetes (T1DM) in the T1-REDEEM trial']",['diabetes education (KnowIt) and one focused directly on diabetes distress (OnTrack'],"['participant implementation costs', 'diabetes distress', 'Cost per unit change in diabetes distress', 'costs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0552523,"No statistically significant differences in costs were observed.
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Shumway', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, Box 0884, San Francisco, CA 94143-0884, USA. Electronic address: martha.shumway@ucsf.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Bowyer', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, 5405 Oberlin Drive #100, San Diego, CA 92121, USA.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Masharani', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Box 1222, San Francisco, CA 94143-1222, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.107416']
941,32439205,"Intraoperative application of inactivated Pseudomonas aeruginosa in patients undergoing lateral neck dissection for metastatic thyroid cancer: A randomized, parallel group, placebo-controlled trial.","BACKGROUND


We hypothesize that the intraoperative, prophylactic application of Pseudomonas aeruginosa can decrease postoperative chylous fistula and enhance recovery after surgery in patients with thyroid cancer undergoing lateral neck lymph node dissection.
METHOD


In this single-center trial, we assigned randomly 200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either 2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field. The primary end points were the rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost. The secondary end points included the red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence.
RESULTS


Patients treated with Pseudomonas aeruginosa had a decrease in macroscopic chylous fistula compared with controls (0 vs 6%, P = .025). There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05). No severe side effects of the Pseudomonas aeruginosa spray with respect to fever, pain, or pleural effusion were observed. Pseudomonas aeruginosa spraying did not affect postoperative recurrence of the thyroid cancer.
CONCLUSION


Intraoperative spraying of inactivated Pseudomonas aeruginosa in the lateral neck compartment can decrease the development of chylous fistula and enhance postoperative recovery.",2020,"There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05).","['patients undergoing lateral neck dissection for metastatic thyroid cancer', 'patients with thyroid cancer undergoing lateral neck lymph node dissection', '200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either']","['Intraoperative application of inactivated Pseudomonas aeruginosa', '2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field', 'placebo']","['macroscopic chylous fistula', 'red blood cell count', 'postoperative recurrence', 'severe side effects', 'red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence', 'rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost', 'volume of drainage fluid, fewer postoperative days of hospital stay', 'fever, pain, or pleural effusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C1096666', 'cui_str': 'Thyroid cancer metastatic'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1066168', 'cui_str': 'Pseudomonas aeruginosa group'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0443174', 'cui_str': 'Chylous'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",200.0,0.224468,"There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Genpeng', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jinen', 'Affiliation': 'State Key Laboratory of Biotherapy, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhihui', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Rixiang', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jianyong', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China. Electronic address: leijianyong11@163.com.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Jingqiang', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}]",Surgery,['10.1016/j.surg.2020.03.020']
942,31339826,Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.,"PURPOSE


The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.
METHODS


Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m 2 , once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016).
RESULTS


In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73;  P  < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed.
CONCLUSION


Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.",2019,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","['Patients With Follicular Lymphoma', 'Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma', 'patients with follicular lymphoma compared with observation', '1,018 patients completed induction treatment']","['immunochemotherapy induction regimens', 'rituximab maintenance', 'Rituximab Maintenance']","['10-year OS estimates', 'final PFS and overall survival (OS', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1018.0,0.177374,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bachy', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Charles University, Hradec Králové, Czech Republic.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Xerri', 'Affiliation': 'Institut Paoli-Calmettes, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Catalano', 'Affiliation': 'Frankston Hospital and Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lemonnier', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Hospital Universitario de Salamanca-Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France.'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Pedersen', 'Affiliation': 'Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': 'Hôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Leppa', 'Affiliation': 'Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gabarre', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Portuguese Institute of Oncology, Lisbon, Portugal.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Glaisner', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Ysebaert', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vekhoff', 'Affiliation': 'Saint Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tanin', 'Initials': 'T', 'LastName': 'Intragumtornchai', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lister', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Concord Hospital, Concord, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Milone', 'Affiliation': 'Fundaleu, Buenos Aires, Argentina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sonet', 'Affiliation': 'UCL, Mont-Godinne, Yvoir, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Farhi', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Zeuner', 'Affiliation': 'F Hoffman-La Roche, Basel, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri-Becquerel, Rouen, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01073']
943,32440816,"Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial.","BACKGROUND


Elderly patients with proximal femoral fractures face elevated risk of post-operative deep vein thrombosis and pulmonary embolism, due to the lack of suitable treatment plans after surgery and hospital discharge. This study aimed to investigate the effect of omega-3 fatty acid supplementation in the above-described clinical setting.
METHODS


Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited. After exclusion, 452 eligible patients were assigned in a random manner to receive either omega-3 fatty acids at the daily dose of 1000 mg or placebo, via oral administration for a period of 30 days after surgery. At the end of intervention, the incidences of pulmonary embolism, deep vein thrombosis, and other related complications were compared between the two study groups.
RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention. But other related complications, such as haematoma evacuation, post-operative wound bleed, wound infection with frank pus, and other bleed events that required transfusion, were not affected after omega-3 fatty acid consumption.
CONCLUSION


Daily supplementation of omega-3 fatty acids decreases the risk of pulmonary embolism as well as symptomatic deep vein thrombosis, after surgery among elderly patients with proximal femoral fractures, without causing elevated risk of bleeding episodes.",2020,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","['elderly patients with proximal femoral fractures', '452 eligible patients', 'Elderly patients with proximal femoral fractures', 'Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited']","['omega-3 fatty acids', 'Omega-3 fatty acids', 'omega-3 fatty acids at the daily dose of 1000 mg or placebo', 'omega-3 fatty acid supplementation', 'placebo']","['risk of pulmonary embolism', 'incidences of pulmonary embolism, deep vein thrombosis, and other related complications', 'deep vein thrombosis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",507.0,0.273138,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","[{'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Rufu', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China. Hlbzxy2@163.com.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}]",International orthopaedics,['10.1007/s00264-020-04610-0']
944,30320641,"Effect of Intravenous Lidocaine, Dexamethasone, and Their Combination on Postoperative Sore Throat: A Randomized Controlled Trial.","BACKGROUND


Postoperative sore throat (POST), hoarseness, and cough after tracheal intubation are not uncommon. Although both lidocaine and dexamethasone have been used independently to reduce these events, there is no study assessing the combined effects of lidocaine and dexamethasone.
METHODS


This prospective, double-blind, randomized controlled study enrolled 180 patients requiring general anesthesia with endotracheal intubation for >90 minutes. They received 1 of the 4 intravenous agents just before induction of anesthesia: lidocaine (1.5 mg/kg) in group L, dexamethasone (8 mg) in group D, lidocaine (1.5 mg/kg) with dexamethasone (8 mg) in group DL, and placebo as normal saline in group NS. Standard anesthesia protocol was followed. Incidence and severity of a sore throat, cough, and hoarseness of voice were assessed up to 24 hours postoperatively. The primary outcome was the incidence of POST, and the main effects of dexamethasone and lidocaine were the primary interest.
RESULTS


Data of 45 patients in D, 44 in L, 44 in DL, and 43 in NS groups were analyzed. The incidence of a sore throat was 36%, 43%, 25%, and 56% in group D, L, DL, and NS, respectively (P = .02). Dexamethasone with or without lidocaine reduced the incidence of the POST (odds ratio, 0.44; 95% confidence interval, 0.24-0.82; P < .01). However, lidocaine was not effective in reducing POST (odds ratio, 0.62; 95% confidence interval, 0.33-1.14; P = .12). No difference was observed in the severity of a sore throat, incidence and severity of a cough, and hoarseness among the groups.
CONCLUSIONS


Dexamethasone, with or without lidocaine, was effective in reducing the incidence of POST in patients requiring prolonged tracheal intubation.",2019,"Dexamethasone with or without lidocaine reduced the incidence of the POST (odds ratio, 0.44; 95% confidence interval, 0.24-0.82; P < .01).","['patients requiring prolonged tracheal intubation', '45 patients in D, 44 in L, 44 in DL, and 43 in NS groups were analyzed', '180 patients requiring general anesthesia with endotracheal intubation for >90 minutes']","['placebo', 'lidocaine', 'Dexamethasone', 'Lidocaine, Dexamethasone, and Their Combination', 'anesthesia: lidocaine', 'dexamethasone and lidocaine', 'dexamethasone']","['severity of a sore throat, incidence and severity of a cough, and hoarseness', 'incidence of the POST', 'Incidence and severity of a sore throat, cough, and hoarseness of voice', 'incidence of a sore throat', 'Postoperative Sore Throat', 'incidence of POST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",180.0,0.55804,"Dexamethasone with or without lidocaine reduced the incidence of the POST (odds ratio, 0.44; 95% confidence interval, 0.24-0.82; P < .01).","[{'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Subedi', 'Affiliation': 'From the Department of Anesthesiology and Critical Care, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Pokharel', 'Affiliation': 'From the Department of Anesthesiology and Critical Care, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Khatiwada', 'Affiliation': 'From the Department of Anesthesiology and Critical Care, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003842']
945,32441544,Strengthening resilience in over 50's: a nested clustered-randomized controlled trial of adaptive systematic self-reflection.,"Background and objectives : This study investigated the efficacy of guided self-reflection to strengthen resilience in adults over 50 by exploring the effects of the training on mental health and positive emotional outcomes.  Design : A nested clustered-randomized controlled trial was conducted to test the efficacy of the training. Measures occurred at pre-intervention, post-intervention, and at four to five months follow-up.  Method:  Two samples of participants were recruited. First, older employees from a consumer goods company took part in the clustered-randomized controlled trial. Ninety-three employees (mean age = 54.02 years; 36.56% females) were assigned to the intervention ( n  = 52) or active control ( n  = 41) group. Second, older adults from the community ( n  = 51) were recruited (mean age = 58.63 years; 80.40% female) and assigned to the intervention only.  Results : Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes. When training engagement was used as a moderator, positive benefits for the corporate intervention group emerged for highly engaged participants. Mediation analyses indicated that stress-as-enhancing mindset, stressor benefit, and coping self-efficacy acted as possible mechanisms for change in primary outcomes.  Conclusions : Findings provide support for the use of guided self-reflection for resilience training with older adults.",2020,"Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes.","['older adults from the community ( n \u2009=\u200951) were recruited (mean age\u2009=\u200958.63 years; 80.40% female', 'older adults', 'Ninety-three employees (mean age\u2009=\u200954.02 years; 36.56% females', 'Method:  Two samples of participants were recruited', ""over 50's""]","['active control', 'guided self-reflection']",['mental health and positive emotional outcomes'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",93.0,0.123693,"Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes.","[{'ForeName': 'Monique F', 'Initials': 'MF', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Kho', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'eCentre Clinic, Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Joanne K', 'Initials': 'JK', 'LastName': 'Earl', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Celia B', 'Initials': 'CB', 'LastName': 'Harris', 'Affiliation': 'Department of Cognitive Science, Macquarie University, North Ryde, Australia.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1768375']
946,31991511,"Efficacy of vibegron, a novel β3-adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo-controlled, double-blind, comparative phase 3 study.","OBJECTIVE


To evaluate the efficacy of a novel and selective β3-adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).
PATIENTS AND METHODS


A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI-free ('diary-dry' rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.
RESULTS


Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were -1.35, -1.47 and -1.08 in all patients, -1.04, -1.13 and -0.89 in the mild/moderate UUI subgroup, and -2.95, -3.28 and -2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary-dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.
CONCLUSIONS


Vibegron, a novel β3-adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.",2020,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"['Patients were subclassified into mild-moderate (>0 to <3 UUI episodes/d) or severe UUI (≥3 UUI episodes/d) subgroup', 'in the vibegron phase 3 study and had UUI episodes ', 'OAB patients', 'severe urgency urinary incontinence related to overactive bladder', 'OAB patients with UUI']","['novel and selective β3-adrenoreceptor agonist vibegron', 'vibegron, a novel β3-adrenoreceptor agonist', 'placebo', 'vibegron or placebo']","['number of UUI episodes', 'response rate', 'Response rates assessed by PGI', 'Diary-dry rate', 'numbers of UUI episodes', 'feeling much better] or 2 [feeling better] assessed by Patient Global Impression', 'urgency urinary incontinence (UUI', 'Change in voided volume/micturition', 'voided volume/micturition', 'number of UUI episodes/d, number of urgency episodes/d, and voided volume/micturition', 'Diary-dry rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3841449', 'cui_str': 'Much better (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]",,0.155688,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Minemura', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",BJU international,['10.1111/bju.15020']
947,31443893,Mindfulness practice predicts interleukin-6 responses to a mindfulness-based alcohol relapse prevention intervention.,"Chronic alcohol misuse can result in chronically elevated interleukin (IL)-6, a pro-inflammatory cytokine, in the bloodstream. Given that Mindfulness-Based Relapse Prevention (MBRP) has been shown to reduce alcohol misuse, MBRP might also be effective in reducing IL-6 concentrations. Past research has found, however, that IL-6 does not respond consistently to mindfulness-based interventions. Building on prior studies, we examined whether between-person variability in engagement with mindfulness training (i.e., formal mindfulness practice time) is associated with between-person variability in changes in serum IL-6, using data from a randomized controlled trial evaluating MBRP for Alcohol Dependence (MBRP-A). Participants were 72 alcohol dependent adults (mean age = 43.4 years, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n = 46) or after a 26-week delay (n = 26). IL-6 concentrations did not significantly change from pre- to post-intervention for the full sample. Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27). The association between practice time and IL-6 changes remained significant when controlling for intervention timing (i.e., immediate or after the 26-week delay), demographic characteristics, and changes in mindful awareness, obsessive-compulsive drinking, and depressive symptoms. The association between practice time and IL-6 changes was not significant when omitting the minimum treatment dose requirement. Overall, results suggest that the level of engagement in mindfulness training may predict changes in the inflammatory pathophysiology in adults with alcohol dependence.",2019,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","['Participants were 72 alcohol dependent adults (mean age\u202f=\u202f43.4\u202fyears, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n\u202f=\u202f46) or after a 26-week delay (n\u202f=\u202f26', 'adults with alcohol dependence']","['Mindfulness-Based Relapse Prevention (MBRP', 'mindfulness training', 'IL-6']","['mindful awareness, obsessive-compulsive drinking, and depressive symptoms', 'reduced IL-6 levels', 'IL-6 concentrations', 'mindfulness practice time', 'practice time and IL-6 changes']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0290657,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'McClintock', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America. Electronic address: asmcclintock@wisc.edu.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Department of Counseling Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Coe', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.018']
948,31189035,Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer.,"BACKGROUND


Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence.
METHODS


In this randomized phase 3 trial, we tested whether 6 months of platinum-based chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapse-free survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life.
RESULTS


Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapse-free survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median follow-up period was 47 months. At 60 months, the Kaplan-Meier estimate of the percentage of patients alive and relapse-free was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapy-only group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5-year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymph-node recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapy-only group.
CONCLUSIONS


Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.).",2019,"CONCLUSIONS


Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.","['Locally Advanced Endometrial Cancer', 'patients with stage III or IVA endometrial carcinoma', '813 patients enrolled', '736 were eligible and were included in the analysis of relapse-free survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only']","['Adjuvant Chemotherapy plus Radiation', 'chemoradiotherapy', 'Chemoradiotherapy', 'platinum-based chemotherapy plus radiation therapy (chemoradiotherapy']","['pelvic and paraaortic lymph-node recurrence', 'distant recurrence', '5-year incidence of vaginal recurrence', 'relapse-free survival', 'longer relapse-free survival', 'Kaplan-Meier estimate of the percentage of patients alive and relapse-free', 'overall survival, acute and chronic toxic effects, and quality of life']","[{'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0229789', 'cui_str': 'Para-aortic node (body structure)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}]",813.0,0.549503,"CONCLUSIONS


Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Matei', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Randall', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mutch', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Steinhoff', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Yong M', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Richards', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nakayama', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': ""From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).""}]",The New England journal of medicine,['10.1056/NEJMoa1813181']
949,32440638,"Anemia and Micronutrient Status during Pregnancy, and Their Associations with Obstetric and Infant Outcomes among HIV-Infected Ugandan Women Receiving Antiretroviral Therapy.","Background


Women living with HIV (WLHIV) are at higher risk of micronutrient deficiencies and adverse health outcomes. There are limited data on the burden or sequelae of micronutrient deficiencies among pregnant WLHIV receiving antiretroviral therapy (ART).
Objectives


We aimed to examine anemia and vitamin B-12, folate, and vitamin D deficiencies, and their associations with obstetric and infant outcomes, among pregnant WLHIV initiating combination antiretroviral therapy (cART) in rural Uganda.
Methods


This was a prospective analysis among pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs), a randomized trial comparing the effects of protease inhibitor (PI)-based ART with those of a non-PI-based ART on placental malaria risk. We conducted a substudy on the burden of anemia [trimester 1/3: hemoglobin (Hb) <11.0 g/dL; trimester 2: Hb <10.5 g/dL;  n  = 367] and micronutrient deficiencies ( n  = 127) in pregnant WLHIV and their associations with obstetric and infant outcomes. Hb was measured by cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D was measured by ELISA. Linear and binomial regression were used to evaluate associations between micronutrient status during pregnancy and perinatal outcomes.
Results


26.8% women were anemic, 30.2% were vitamin B-12 insufficient (<221.0 pmol/L), 66.1% were folate insufficient (<13.5 nmol/L), and 65.4% were vitamin D insufficient (<30.0 ng/mL) at enrollment. Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001). Multivariate models showed that increased vitamin D concentrations predicted lower risk of infant wasting (WLZ < -2; RR: 0.94; 95% CI: 0.89, 0.99;  P  = 0.04). Multivariate models also indicated that maternal vitamin B-12 and folate concentrations at enrollment predicted maternal ( P  < 0.001) and infant ( P  = 0.02) concentrations postpartum.
Conclusions


Anemia and micronutrient deficiencies are associated with a variety of adverse obstetric and infant outcomes and are an important public health concern in perinatal WLHIV on cART and their children.This trial was registered at clinicaltrials.gov as NCT00993031.",2020,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","['anemia [trimester 1/3: hemoglobin (Hb)\xa0<11.0 g/dL; trimester 2', 'pregnant WLHIV receiving antiretroviral therapy (ART', 'pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs', 'HIV-Infected Ugandan Women Receiving Antiretroviral Therapy', '\n\n\nWomen living with HIV (WLHIV']","['protease inhibitor (PI)-based ART with those of a non-PI-based ART', 'pregnant WLHIV initiating combination antiretroviral therapy (cART']","['cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D', 'maternal vitamin B-12 and folate concentrations', 'Anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0056663', 'cui_str': 'Cyanmethemoglobin'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",367.0,0.327726,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Herman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Plenty', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': ""Division of Infectious Disease, Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sera L', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Department of Anthropology and Global Health Studies, Northwestern University, Evanston, IL, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa075']
950,32440646,Uncommitted Commitment: Behavioral Strategy to Prevent Preference Reversals.,"When both smaller-sooner (SS) and larger-later (LL) rewards are temporally distal, individuals frequently prefer the LL. However, because both outcomes become proximal, individuals frequently switch to preferring the SS. These preference reversals are predicted by hyperbolic delay discounting, and may model the essential challenge of self-control. Using smokers, a population known to have high rates of delay discounting, and thus more vulnerable to preference reversals, this pilot study sought to examine  soft commitment  as a strategy that may prevent preference reversals. Eleven smokers were assigned to an experimental commitment condition, operationalized as 3 weeks of daily commitment trials indicating preference between an SS and LL. Ten smokers were assigned to a control commitment condition. These 3 weeks were followed by 8 days of daily choice trials indicating preference between an impending SS and LL, for both experimental and control conditions. Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group. This pilot study provides an initial indication that soft commitment can facilitate choice persistence and prevent preference reversals.",2020,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.",['Eleven smokers'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],11.0,0.0233431,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milhorn', 'Affiliation': '2University of Maryland, College Park, MD USA.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Kayla N', 'Initials': 'KN', 'LastName': 'Tormohlen', 'Affiliation': '3Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD USA.'}, {'ForeName': 'Jama', 'Initials': 'J', 'LastName': 'Bettis', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}]",Perspectives on behavior science,['10.1007/s40614-019-00229-8']
951,31461239,"A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial.","AIMS


Stroke is often a devastating event among patients with heart failure with reduced ejection (HFrEF). In COMMANDER HF, rivaroxaban 2.5 mg b.i.d. did not reduce the composite of first occurrence of death, stroke, or myocardial infarction compared with placebo in patients with HFrEF, coronary artery disease (CAD), and sinus rhythm. We now examine the incidence, timing, type, severity, and predictors of stroke or a transient ischaemic attack (TIA), and seek to establish the net clinical benefit of treatment with low-dose rivaroxaban.
METHODS AND RESULTS


In this double-blind, randomized trial, 5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with rivaroxaban 2.5 mg b.i.d. or placebo in addition to antiplatelet therapy, after an episode of worsening HF. The primary neurological outcome for this post hoc analysis was time to first event of any stroke or TIA. Over a median follow-up of 20.5 (25th-75th percentiles 20.0-20.9) months, 150 all-cause stroke (127) or TIA (23) events occurred (ischaemic stroke in 82% and haemorrhagic stroke in 11% of stroke events). Overall, 47.5% of first-time strokes were either disabling (16.5%) or fatal (31%). Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score were predictors of stroke/TIA. Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49-0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event. The principal safety endpoint of fatal bleeding or bleeding into a critical space, occurred at a similar rate on rivaroxaban and placebo (0.44 events vs. 0.55 events per 100 patient-years).
CONCLUSIONS


Patients with HFrEF and CAD are at risk for stroke or TIA in the period following an episode of worsening heart failure in the absence of atrial fibrillation. Most strokes are of ischaemic origin and nearly half are either disabling or fatal. Rivaroxaban at a dose of 2.5 mg b.i.d. reduced rates of stroke or TIA compared with placebo in this population.
TRIAL REGISTRATION


COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure); ClinicalTrials.gov NCT01877915.",2019,"Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49–0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event.","['patients with heart failure, coronary artery disease, and sinus rhythm', 'Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure', 'patients with HFrEF, coronary artery disease (CAD), and sinus rhythm', 'patients with heart failure with reduced ejection (HFrEF', '5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with']","['placebo', 'rivaroxaban 2.5\u2009mg b.i.d', 'HF ', 'Rivaroxaban', 'rivaroxaban and placebo', 'rivaroxaban']","['composite of first occurrence of death, stroke, or myocardial infarction', 'fatal bleeding or bleeding into a critical space', 'Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score', 'Risk of Death, Myocardial Infarction, or Stroke', 'TIA (23) events occurred (ischaemic stroke', 'time to first event of any stroke or TIA', 'primary neurological endpoint of all-cause stroke or TIA', 'reduced rates of stroke or TIA', 'haemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4049268', 'cui_str': 'CHA2DS2-VASc score'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]",150.0,0.499769,"Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49–0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event.","[{'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, LLC, Whippany, NJ, USA.'}, {'ForeName': 'Hsiaowei', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz427']
952,31421033,Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial.,"OBJECTIVE


To assess performance of psoriatic arthritis (PsA) composite indices and evaluate guselkumab's effect on achieving low disease activity or remission.
METHODS


In this phase II trial, patients with active PsA (≥3 tender and ≥3 swollen joints, C-reactive protein level ≥0.3 mg/dl, ≥3% body surface-area with psoriasis involvement) were randomized 2:1 to subcutaneous guselkumab 100 mg (n = 100) or placebo (n = 49) at week 0, week 4, and every 8 weeks through week 44. At week 16, patients with <5% improvement in swollen and tender joints could early escape to open-label ustekinumab. Patients continuing placebo crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 (placebo to guselkumab). PsA composite indices (Psoriatic Arthritis Disease Activity Score [PASDAS], Group for Research and Assessment of Psoriasis and Psoriatic Arthritis composite score [GRACE], modified Composite Psoriatic Disease Activity Index [mCPDAI], and Disease Activity in Psoriatic Arthritis [DAPSA]) were analyzed as secondary outcomes (last observation carried forward for missing/post-early escape data through week 24; observed data post-week 24). Instrument performance was assessed.
RESULTS


Baseline PASDAS, GRACE, mCPDAI, and DAPSA scores indicated moderate-to-high disease activity. At week 24, mean changes in each of these composite indices showed significant improvement with guselkumab (-2.50, -2.73, -3.8, and -23.08, respectively) versus placebo (-0.49, 0.35, -0.8, and -4.98, respectively; P < 0.001 for all). Significantly more guselkumab-treated patients achieved low/very low/remitted disease activity states according to PASDAS (very low + low 35% versus 4%; P < 0.001), GRACE (30% versus 2%; P < 0.001), mCPDAI (46% versus 10%; P < 0.001), and DAPSA (remission + low 40% versus 12%; P < 0.001). A total of 12% of guselkumab-treated versus no placebo-treated patients achieved DAPSA remission (P < 0.01). The PASDAS and GRACE instruments were more sensitive than the mCPDAI and DAPSA tools in detecting treatment effect. Residual skin disease and enthesitis were marginally more prominent in patients achieving DAPSA low disease activity versus other indices.
CONCLUSION


Guselkumab demonstrated efficacy in achieving low disease activity/remission based on all PsA composite indices assessed. Composite index use in PsA trials and the clinic requires careful consideration to optimize feasibility and instrument performance.",2020,"p<0.001), GRACE (29.6% vs. 2.1%; p<0.001), mCPDAI (45.9% vs. 10.4%, p<0.001), and DAPSA (remission+low 40.0% vs. 12.2%; p<0.001); 12% of guselkumab-treated vs. no placebo-treated patients achieved DAPSA remission (p<0.01).","['patients with active PsA (≥3 tender and ≥3 swollen joints, C-reactive protein ≥0.3 mg/dL, ≥3% body-surface-area psoriasis involvement', 'Psoriatic Arthritis']","['placebo', 'subcutaneous guselkumab 100 mg (N=100) or placebo', 'guselkumab', 'Guselkumab']","['mCPDAI', 'Residual skin disease and enthesitis', 'PsA composite indices (Psoriatic ArthritiS Disease Activity Score [PASDAS], GRAppa Composite scorE [GRACE], modified Composite Psoriatic Disease Activity Index [mCPDAI], Disease Activity index for PSoriatic Arthritis [DAPSA', 'DAPSA remission', 'swollen and tender joints could early escape (EE', 'GRACE', 'GRACE, mCPDAI, and DAPSA scores indicated moderate-to-high disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.182962,"p<0.001), GRACE (29.6% vs. 2.1%; p<0.001), mCPDAI (45.9% vs. 10.4%, p<0.001), and DAPSA (remission+low 40.0% vs. 12.2%; p<0.001); 12% of guselkumab-treated vs. no placebo-treated patients achieved DAPSA remission (p<0.01).","[{'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Geneva University Hospitals and University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, and University of Pennsylvania Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Krembil Research Institute, and Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}]",Arthritis care & research,['10.1002/acr.24046']
953,32087620,Accuracy of a Novel 3D-Printed Patient-Specific Intramedullary Guide to Control Femoral Component Rotation in Total Knee Arthroplasty.,"OBJECTIVE


Total knee arthroplasty (TKA) is one of the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. Accurate intramedullary guide of femur is the basis for the distal femoral cuts. Determining the surgical transepicondylar axis (sTEA) is the key to reconstruction of the femoral rotational alignment, because the correct rotational alignment can place the femoral component in the right position, balance the flexion gap so that the inner and outer tension is equal, get stability during the flexion process of the knee, and enhance the quality of life of patients. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to evaluate the accuracy of a novel 3D-printed patient-specific intramedullary guide to control femoral component rotation in TKA.
METHODS


Eighty patients (65 females and 15 males) with knee OA were included in this prospective randomized study. The patients were divided into two groups by random number table method, 40 in each group. TKA assisted by PSI (PSI group) and conventional TKA (conventional group) was performed respectively. Clinical outcomes [operation time, postoperative drainage volume, duration of drainage, Hospital for Special Surgery knee score (HSS), American Knee Society knee score (AKS)] and radiological outcomes [hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA), depth of intramedullary guide] were compared between and within the two groups.
RESULTS


PSI group had less postoperative drainage volume but longer operation time than the conventional group (P < 0.05). The AKS and HSS scores after surgery were improved compared with those before surgery in each group (P < 0.05). However, there was no significant difference in the duration of drainage and range of motion (ROM) after surgery between the two groups. For the radiological results, the HKA and PFA were improved after surgery in both groups (P < 0.05).The postoperative PFA and PCA of the PSI group were closer to 0°, which was better than that of the conventional group (P < 0.05). The depth of intramedullary guide in the PSI group was less than the conventional group (P < 0.05). But there was no significant difference in HKA before and after surgery between the two groups as well as the preoperative PFA.
CONCLUSION


The short-term clinical efficacy of TKA assisted by PSI was similar to the conventional TKA. Although TKA assisted by PSI spent more time during operation, it could assist in intramedullary guide and align femoral rotation more accurately.",2020,"RESULTS


PSI group had less postoperative drainage volume but longer operation time than the conventional group (P < 0.05).","['Eighty patients (65 females and 15 males) with knee OA', 'Total Knee Arthroplasty']","['TKA', 'TKA assisted by PSI (PSI group) and conventional TKA', 'Novel 3D-Printed Patient-Specific Intramedullary Guide to Control Femoral Component Rotation', 'Total knee arthroplasty (TKA', 'novel 3D-printed patient-specific intramedullary guide to control femoral component rotation']","['AKS and HSS scores', 'HKA', 'postoperative drainage volume', 'HKA and PFA', 'depth of intramedullary guide', 'duration of drainage and range of motion (ROM', 'Clinical outcomes [operation time, postoperative drainage volume, duration of drainage, Hospital for Special Surgery knee score (HSS), American Knee Society knee score (AKS)] and radiological outcomes [hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA), depth of intramedullary guide']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]",80.0,0.0241108,"RESULTS


PSI group had less postoperative drainage volume but longer operation time than the conventional group (P < 0.05).","[{'ForeName': 'Mao-Lin', 'Initials': 'ML', 'LastName': 'Sun', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'De-Jie', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Hua-Quan', 'Initials': 'HQ', 'LastName': 'Fan', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}]",Orthopaedic surgery,['10.1111/os.12619']
954,31424243,Graphic health warning posters increase some adolescents' future cigarette use susceptibility by changing normative perceptions of smoking: A case of mediated moderation.,"Prior work suggests that exposure to graphic health warning posters (GWPs) at retail point-of-sale may increase future cigarette smoking susceptibility in adolescents who are already at risk for future smoking, but not among committed never-smokers. However, little is known about what psychological mechanisms may account for this effect of GWPs on at-risk youths. Participants ( N  = 441) aged 11-17 years were randomized to experimental shopping conditions in a life-sized model convenience store, in which GWPs were absent (""status quo"";  n  = 107) or visibly displayed near the check-out area ( n  = 334). Participants completed pre- and post- ""shopping"" measures of future smoking susceptibility, descriptive and injunctive smoking norms, and perceived harms of smoking. A series of linear regression analyses assessed whether norms and harms differentially mediated the effect of experimental condition on future smoking susceptibility in committed never smokers compared with at-risk youths. Tests showed evidence for mediated moderation of the effect of GWP exposure on future smoking susceptibility, such that changes in injunctive norms (i.e., greater perceived social disapproval)-but not descriptive norms or perceived smoking harms-partially accounted for the effect of GWPs on smoking susceptibility in at-risk youths (average causal mediation effect: B = 0.51 [0.14-1.22],  p  = .02), but not among committed never smokers. For adolescents already at risk of future smoking, GWPs increase perceptions of cigarettes as less socially acceptable, which may increase susceptibility to future smoking in this group. Future work should examine reactance to antismoking messaging among youth at risk for future smoking. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,A series of linear regression analyses assessed whether norms and harms differentially mediated the effect of experimental condition on future smoking susceptibility in committed never smokers compared with at-risk youths.,"['smoking', 'Participants ( N  = 441) aged 11-17 years']",['Graphic health warning posters'],['smoking susceptibility'],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376675', 'cui_str': 'Poster'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",2019.0,0.0148745,A series of linear regression analyses assessed whether norms and harms differentially mediated the effect of experimental condition on future smoking susceptibility in committed never smokers compared with at-risk youths.,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Dunbar', 'Affiliation': 'Department of Social and Economic Wellbeing.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Setodji', 'Affiliation': 'Department of Social and Economic Wellbeing.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Martino', 'Affiliation': 'Department of Social and Economic Wellbeing.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Shadel', 'Affiliation': 'Department of Social and Economic Wellbeing.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000503']
955,31424503,"Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy: a double-blind, multicentre, randomized trial.","AIMS


Although loop diuretics are widely used to treat heart failure (HF), there is scarce contemporary data to guide diuretic adjustments in the outpatient setting.
METHODS AND RESULTS


In a prospective, randomized and double-blind protocol, we tested the safety and tolerability of withdrawing low-dose furosemide in stable HF outpatients at 11 HF clinics in Brazil. The trial had two blindly adjudicated co-primary outcomes: (i) symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale evaluated at 4 time-points (baseline, Day 15, Day 45, and Day 90) and (ii) the proportion of patients maintained without diuretic reuse during follow-up. We enrolled 188 patients (25% females; 59 ± 13 years old; left ventricular ejection fraction = 32 ± 8%) that were randomized to furosemide withdrawal (n = 95) or maintenance (n = 93). For the first co-primary endpoint, no significant difference in patients' assessment of dyspnoea was observed in the comparison of furosemide withdrawal with continuous administration [median AUC 1875 (interquartile range, IQR 383-3360) and 1541 (IQR 474-3124), respectively; P = 0.94]. For the second co-primary endpoint, 70 patients (75.3%) in the withdrawal group and 77 patients (83.7%) in the maintenance group were free of furosemide reuse during follow-up (odds ratio for additional furosemide use with withdrawal 1.69, 95% confidence interval 0.82-3.49; P = 0.16). Heart failure-related events (hospitalizations, emergency room visits, and deaths) were infrequent and similar between groups (P = 1.0).
CONCLUSIONS


Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse. Diuretic discontinuation may deserve consideration in stable outpatients with no signs of fluid retention receiving optimal medical therapy.
CLINICALTRIALS.GOV IDENTIFIER


NCT02689180.",2019,"CONCLUSIONS


Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse.","['stable outpatients with mild heart failure and no fluid retention receiving optimal therapy', 'stable HF outpatients at 11 HF clinics in Brazil', 'stable outpatients with no signs of fluid retention receiving optimal medical therapy', '188 patients (25% females; 59\u2009±\u200913\u2009years old; left ventricular ejection fraction\u2009=\u200932\u2009±\u20098']","['furosemide withdrawal', 'withdrawing low-dose furosemide', 'Diuretic discontinuation']","['safety and tolerability', 'self-perception of dyspnoea', 'symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale', 'Heart failure-related events (hospitalizations, emergency room visits, and deaths', ""patients' assessment of dyspnoea"", 'free of furosemide reuse']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]",188.0,0.149786,"CONCLUSIONS


Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse.","[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Rohde', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marciane M', 'Initials': 'MM', 'LastName': 'Rover', 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Figueiredo Neto', 'Affiliation': 'Hospital Universitário da Universidade Federal do Maranhão, São Luis, MA, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Danzmann', 'Affiliation': 'Hospital Universitário da Universidade Luterana do Brasil, Canoas, RS, Brazil.'}, {'ForeName': 'Eduardo G', 'Initials': 'EG', 'LastName': 'Bertoldi', 'Affiliation': 'Hospital Escola da Universidade Federal de Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Marcus V', 'Initials': 'MV', 'LastName': 'Simões', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Odilson M', 'Initials': 'OM', 'LastName': 'Silvestre', 'Affiliation': 'Universidade Federal do Acre, Rio Branco, AC, Brazil.'}, {'ForeName': 'Antonio L P', 'Initials': 'ALP', 'LastName': 'Ribeiro', 'Affiliation': 'Hospital da Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Lidia Zytynski', 'Initials': 'LZ', 'LastName': 'Moura', 'Affiliation': 'Hospital Universitário Cajuru da Pontifícia Universidade Católica, Curitiba, PR, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Beck-da-Silva', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Prado', 'Affiliation': 'Hospital da Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Roberto T', 'Initials': 'RT', 'LastName': ""Sant'Anna"", 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Leonardo H', 'Initials': 'LH', 'LastName': 'Bridi', 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Zimerman', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Raupp da Rosa', 'Affiliation': 'Hospital São Lucas da Pontifícia Universidade Católica, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andréia', 'Initials': 'A', 'LastName': 'Biolo', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}]",European heart journal,['10.1093/eurheartj/ehz554']
956,31221553,tDCS to the left DLPFC modulates cognitive and physiological correlates of executive function in a state-dependent manner.,"BACKGROUND


The use of transcranial Direct Current Stimulation (tDCS) to study anatomical and physiological dynamics and circuits supporting cognition and executive functions in particular has dramatically increased in recent years. However, its mechanisms of action remain only partially understood.
OBJECTIVE


In this study we assess the cognitive and physiological effects of anodal tDCS to the DLPFC on executive function in order to understand (1) the role of DLPFC laterality, (2) the physiological dynamics sustaining the modulation of executive function by tDCS, and (3) the impact of state-dependent dynamics.
METHODS


In a randomized, placebo-controlled, cross-over study, we applied anodal tDCS targeting the left vs. right DLPFC vs. sham in 20 healthy individuals (10 males, 10 females). Immediately before and after tDCS, subjects performed the Flanker Task while we measured behavioral (reaction time and accuracy) and neurophysiological (ERP) responses. Specifically, the amplitude of N200, P300, ERN and Pe is compared before and after stimulation.
RESULTS


Anodal tDCS to the left DLPFC lead to a significant improvement in reaction time, an increase in P300 amplitude and a decrease in N200 amplitude in a state-dependent manner: baseline ERP amplitudes conditioned the effects of tDCS.
CONCLUSION


Given the role of these ERPs in conflict-related tasks, we speculate that tDCS is modulating the subconstructs of selective attention, conflict monitoring and response inhibition. These findings contribute to a further understanding of the role of left DLPFC in the modulation of executive function, and shed light into the mechanisms of action and the state dependent nature of tDCS.",2019,"RESULTS


Anodal tDCS to the left DLPFC lead to a significant improvement in reaction time, an increase in P300 amplitude and a decrease in N200 amplitude in a state-dependent manner: baseline ERP amplitudes conditioned the effects of tDCS.
","['20 healthy individuals (10 males, 10 females']","['anodal tDCS', 'anodal tDCS targeting the left vs. right DLPFC vs. sham', 'transcranial Direct Current Stimulation (tDCS', 'placebo']","['amplitude of N200, P300, ERN and Pe', 'P300 amplitude', 'reaction time', 'behavioral (reaction time and accuracy) and neurophysiological (ERP) responses']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444781', 'cui_str': 'P300 (P3) (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",20.0,0.0206259,"RESULTS


Anodal tDCS to the left DLPFC lead to a significant improvement in reaction time, an increase in P300 amplitude and a decrease in N200 amplitude in a state-dependent manner: baseline ERP amplitudes conditioned the effects of tDCS.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dubreuil-Vall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Laboratory for Neuropsychiatry and Neuromodulation, 149 13th st. 2nd floor, Boston, MA, 02129, USA; Department of Psychiatry and Clinical Psychobiology, Universitat de Barcelona, Casanova 143, 08036, Barcelona, Spain; Neuroelectrics Corporation, 210 Broadway, Suite 201, Cambridge, MA, 02139, USA. Electronic address: ldubreuilvall@mgh.harvard.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Chau', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Laboratory for Neuropsychiatry and Neuromodulation, 149 13th st. 2nd floor, Boston, MA, 02129, USA.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics Corporation, 210 Broadway, Suite 201, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Alik S', 'Initials': 'AS', 'LastName': 'Widge', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Laboratory for Neuropsychiatry and Neuromodulation, 149 13th st. 2nd floor, Boston, MA, 02129, USA.'}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Camprodon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Laboratory for Neuropsychiatry and Neuromodulation, 149 13th st. 2nd floor, Boston, MA, 02129, USA.'}]",Brain stimulation,['10.1016/j.brs.2019.06.006']
957,32441709,Evaluation of the effect of endoscopic partial middleturbinectomy surgery on the quality of life of patients with chronic rhinosinusitis and nasal polyps.,"BACKGROUND


Chronic rhinosinusitis (CRS) is a common chronic inflammatory disease. Endoscopic sinus surgery is recommended as a standard method when medical treatment fails. The effectiveness of various complementary surgical methods such as endoscopic partial middle-turbinectomy is controversial in the improvement of CRS symptoms in these patients. This study aimed to investigate the effect of endoscopic partial middle-turbinectomy on the quality of life (QOL) of patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran.
METHOD


Ninety patients with CRSwNP of grades 3 and 4 were randomly assigned to either an intervention (45 patients) or control group (45 patients). In the control group, endoscopic sinus surgery without middle turbinectomy was performed and in the intervention group, endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery. To evaluate the outcomes, the SNOT-22 QOL questionnaire was used, and the results were analyzed using SPSS version 24.
RESULTS


Most of the patients were male and had a mean age of 39 years. The mean SNOT-22 QOL questionnaire scores were 49.13 ± 16.72 and 52.51 ± 16.95 before surgery in the control and intervention groups respectively, which did not show any significant difference. In contrast, after endoscopic surgery these scores changed to 28.46 ± 12.38 and 11.13 ± 5.55 in the control and intervention groups, respectively and there was a significant difference between both groups. Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (± 16.46)) vs 30.7 (±18.27), respectively CONCLUSION: According to this study, it appears that the use of endoscopic partial middle-turbinectomy in addition to endoscopic sinus surgery improves CRS symptoms and the QOL of patients compared with endoscopic sinus surgery alone.",2020,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","['patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran', 'patients were male and had a mean age of 39 years', 'patients with chronic rhinosinusitis and nasal polyps', 'Chronic rhinosinusitis (CRS', 'Ninety patients with CRSwNP of grades 3 and 4']","['endoscopic partial middleturbinectomy surgery', 'endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery', 'Endoscopic sinus surgery', 'endoscopic partial middle-turbinectomy', 'endoscopic sinus surgery without middle turbinectomy']","['quality of life', 'mean SNOT-22 QOL questionnaire scores', 'quality of life (QOL', 'SNOT-22 QOL questionnaire', 'CRS symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0323866,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Delarestaghi', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rajaeih', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jamali', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roomiani', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Memari', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jahandideh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Rhinology,['10.4193/Rhin19.258']
958,32437174,"A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial.","OBJECTIVE


To remedy the notable gap in evidence-based treatments for sexual minority women, this study tested the efficacy of a minority-stress-focused cognitive-behavioral treatment intended to improve this population's mental and behavioral health.
METHOD


The intervention, EQuIP (Empowering Queer Identities in Psychotherapy), was adapted from a transdiagnostic cognitive-behavioral treatment as also recently adapted for sexual minority men. Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health. The resulting treatment was then delivered to young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use.
RESULTS


Compared to waitlist ( n  = 30), participants randomized to immediately receive EQuIP ( n  = 30) experienced significantly reduced depression and anxiety ( d  = 0.85, 0.86, respectively); effects for alcohol use problems were smaller ( d  = 0.29) and marginally significant. In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
CONCLUSIONS


This study provides initial support for a minority-stress-focused transdiagnostic cognitive-behavioral treatment for sexual minority women. These first results can launch exploration of other mechanisms and modalities through which to equip this population with evidence-based support. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","['sexual minority men', ""Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health"", ""gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use"", 'sexual minority women', 'young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use']","['transdiagnostic minority stress intervention', 'EQuIP']","['universal risk factors', 'depression and anxiety']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0292329,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Fetzner', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Cal D', 'Initials': 'CD', 'LastName': 'Brisbin', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Scheer', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Lehavot', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value-Driven Care.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000508']
959,31432311,Anti-infective therapy of peri-implant mucositis with adjunctive delivery of a sodium hypochlorite gel: a 6-month randomized triple-blind controlled clinical trial.,"OBJECTIVE


To evaluate the effects of adjunctive delivery of a sodium hypochlorite gel in the treatment of peri-implant mucositis (PM).
MATERIALS AND METHODS


Forty-six subjects with 68 implants diagnosed with PM were randomly assigned to two treatment groups. Prior to mechanical debridement, a sodium hypochlorite gel was delivered to the implants of the test group while implants of the control group received a placebo gel. Application of both test and placebo gels was repeated 5 times at baseline. The primary outcome variable was the change in pocket probing depth (PPD) between baseline and 6 months.
RESULTS


After 6 months, the mean PPD decreased statistically significantly from 3.93 ± 1.09 mm to 3.04 ± 0.46 mm in the test (p = 0.0001) and from 3.68 ± 0.85 mm to 3.07 ± 0.58 mm in the control (p = 0.0001) group, respectively. No statistically significant difference (p = 0.53) was observed with respect to PPD changes from baseline to 6 months between test (0.88 ± 1.04 mm) and control group (0.61 ± 0.75 mm), respectively. The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
CONCLUSIONS


In conclusion and within the limits of the present study, changes in PPD from baseline to 6 months were not statistically significantly different between groups. Complete resolution of mucosal inflammation was not achieved with either of the therapies.
CLINICAL RELEVANCE


The present outcomes have showed that a complete resolution of peri-implant mucositis is not possible to obtain by means mechanical debridement with or without a sodium hypochlorite gel application.",2020,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","['peri-implant mucositis (PM', 'Forty-six subjects with 68 implants diagnosed with PM']","['placebo', 'placebo gel', 'sodium hypochlorite gel']","['mean PPD', 'PPD changes', 'Complete resolution of mucosal inflammation', 'change in pocket probing depth (PPD', 'number of implants with bleeding on probing (BoP']","[{'cui': 'C3698407', 'cui_str': 'Dental peri-implant mucositis (disorder)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}]",46.0,0.138324,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Stefan-Ioan', 'Initials': 'SI', 'LastName': 'Stratul', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Darian', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}]",Clinical oral investigations,['10.1007/s00784-019-03060-2']
960,32013717,Usefulness of Abdominal Drain in Laparoscopic Roux-en-Y Gastric Bypass: A Randomized Controlled Trial.,"Background:  Laparoscopic Roux-en-Y gastric bypass (RYGB) is one of the most common procedures to treat morbid obesity. Abdominal drains are often placed during the operation to detect complications earlier. The aim of this study was to assess the benefit of routine drain placement during laparoscopic RYGB.  Materials and Methods:  A consecutive series of patients undergoing laparoscopic RYGB between 2017 and 2018 was analyzed. The sample was randomized before the procedure into two groups: with abdominal drain (G1) and without abdominal drain placement (G2). Patients with intraoperative complications were excluded from the randomization. Postoperative complications and pain (visual analogue scale) were compared between groups.  Results:  A total of 84 patients were included; 45 belonged to G1 and 39 to G2. Mean age (G1 44 years versus G2 48 years) and body mass index (G1 43 kg/m 2  versus G2 44 kg/m 2 ) were similar in both groups. There were no significant differences between groups in preoperative comorbidities. Mean operative time was 92 minutes in both groups. Mean pain score at postoperative day 0 was similar in both groups (G1 3.2 versus G2 3.5,  P  = .58), but was higher in G1 at postoperative day 1 (G1 3.1, G2 1.1,  P  = .02). Postoperative Clavien-Dindo I-II complications were similar in both groups (G1 9% versus G2 1%,  P  = .37). No major complications, reoperations, or 30-day mortality occurred in the entire cohort.  Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications. Routine placement of abdominal drain in laparoscopic RYGB might not be recommended.",2020,Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications.,"['Mean age (G1 44 years versus G2 48 years) and body mass index (G1 43\u2009kg/m 2  versus G2 44\u2009kg/m 2 ', 'Laparoscopic Roux-en-Y Gastric Bypass', 'patients undergoing laparoscopic RYGB between 2017 and 2018 was analyzed', 'A total of 84 patients were included; 45 belonged to G1 and 39 to G2', 'Patients with intraoperative complications']","['Abdominal Drain', 'abdominal drain (G1) and without abdominal drain placement (G2', 'Drain placement', 'routine drain placement', 'Laparoscopic Roux-en-Y gastric bypass (RYGB']","['Mean operative time', 'major complications, reoperations, or 30-day mortality', 'Postoperative Clavien-Dindo I-II complications', 'postoperative pain', 'Mean pain score', 'Postoperative complications and pain (visual analogue scale', 'preoperative comorbidities']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}]","[{'cui': 'C0441140', 'cui_str': 'Abdominal drain (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",84.0,0.280267,Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications.,"[{'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Peña', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Schlottmann', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Laxague', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Emmanuel Ezequiel', 'Initials': 'EE', 'LastName': 'Sadava', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Buxhoeveden', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0783']
961,31856496,A novel standardized reproducible method to calculate the area of internal limiting membrane peeled intra-operatively in macular hole surgery by using a video overlay-A long-term study in cases of idiopathic macular holes.,"Purpose


To calculate AIP and to find correlation between hole closure pattern with AIP in idiopathic full thickness macular hole (FTMH) cases.
Methods


In this prospective, non-randomized, interventional single blind study, 105 eyes of symptomatic FTMH (<6 month duration) were operated. Minimal diameter of macular hole (MDMH) was calculated on OCT, divided into Group I (>400μ, n = 75) and Group II (<400μ, n = 30). 23G vitrectomy with ILM peeling and gas injection were done in all and recorded. Final area of ILM peeled (AIP) was calculated using Adobe Photoshop CS2 (PSD format) in disc diameters (DD) from still frame. Follow up was done at 6 monthly interval up to a maximum of 5 years after surgery.
Results


Macular holes were closed in 92.38% eyes. In Group I, mean pre-operative BCVA was 1.14 ± 0.39 log MAR and was improved to 0.79 ± 0.26 log MAR post-operatively at 6 months. In Group II, mean pre-operative BCVA was 0.95 ± 0.44 log MAR and was improved to 0.60 ± 0.24 log MAR after surgery. When AIP was more than 3DD, Type I and Type II closure were 72.77% and 27.27% in Group I (P value <0.01) and 84.21% and 15.79% in Group II (P value <0.01).
Conclusion


AIP can be calculated using Adobe Photoshop CS2. Type I closure was significantly high with AIP >3DD in both groups. Intra-operatively using video overlay, surgeons can increase the diameter of AIP to get better closure pattern.",2020,Type I closure was significantly high with AIP >,"['105 eyes of symptomatic FTMH (<6 month duration) were operated', 'idiopathic full thickness macular hole (FTMH) cases']","['hole closure pattern with AIP', '23G vitrectomy with ILM peeling and gas injection']","['mean pre-operative BCVA', 'Macular holes', 'Minimal diameter of macular hole (MDMH', 'Final area of ILM peeled (AIP']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0470542', 'cui_str': '23G (qualifier value)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0265273,Type I closure was significantly high with AIP >,"[{'ForeName': 'Subhendu K', 'Initials': 'SK', 'LastName': 'Boral', 'Affiliation': 'Disha Eye Hospitals Private Limited, Kolkata, West Bengal, India.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Disha Eye Hospitals Private Limited, Kolkata, West Bengal, India.'}, {'ForeName': 'Tushar K', 'Initials': 'TK', 'LastName': 'Sinha', 'Affiliation': 'Disha Eye Hospitals Private Limited, Kolkata, West Bengal, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_589_19']
962,32140973,"Sense of coherence and its relationship to participation, cancer-related fatigue, symptom burden, and quality of life in women with breast cancer participating in the OptiTrain exercise trial.","PURPOSE


This study examined the Sense of Coherence (SOC) of patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain) study and assessed how patient characteristics were associated with SOC. Secondary aims were to assess the association between SOC and patients' participation in this study and to determine whether SOC moderates the effect of the 16-week exercise intervention on fatigue, quality of life (QoL), and symptom burden in women with breast cancer undergoing chemotherapy.
METHODS


Modified Poisson regression analyses were conducted to determine the relative risk of weak-normal SOC versus strong SOC in terms of exercise session attendance, study and intervention dropout, and long absence rates. Analyses of covariance were performed to assess whether SOC moderated the effect of the exercise intervention (p interaction  ≤ 0.10).
RESULTS


Two hundred and forty women with early breast cancer (mean age 53 ± 10) participated in the OptiTrain study. Women with strong SOC reported less fatigue, lower symptom burden, and higher QoL. Women with weak-normal SOC were significantly more likely to drop out from the OptiTrain study and tended to have slightly poorer exercise session attendance. Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
CONCLUSIONS


Strong SOC appears to be associated with a more positive subjective state of health. Women with weak-normal SOC may need additional support to encourage participation and adherence in exercise trials. Assessing SOC may assist clinicians to identify and provide extra support for participants with weak SOC, who may be less inclined to participate in exercise programs.",2020,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","['women with breast cancer undergoing chemotherapy', 'Women with weak-normal SOC', 'Women with breast cancer and weaker SOC', 'women with breast cancer participating in the OptiTrain exercise trial', 'Two hundred and forty women with early breast cancer (mean age 53\u2009±\u200910) participated in the OptiTrain study', ""patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain"", 'participants with weak SOC']",['exercise intervention'],"['participation, cancer-related fatigue, symptom burden, and quality of life', 'fatigue, quality of life (QoL), and symptom burden']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",240.0,0.059464,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. a.e.hiensch-2@umcutrecht.nl.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05378-0']
963,31410618,VITAL Start: Video-Based Intervention to Inspire Treatment Adherence for Life-Pilot of a Novel Video-Based Approach to HIV Counseling for Pregnant Women Living with HIV.,"We developed and piloted a video-based intervention targeting HIV-positive pregnant women to optimize antiretroviral therapy (ART) retention and adherence by providing a VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) before ART. VITAL Start (VS) was grounded in behavior-determinant models and developed through an iterative multi-stakeholder process. Of 306 pregnant women eligible for ART, 160 were randomized to standard of care (SOC), 146 to VS and followed for one-month. Of those assigned to VS, 100% completed video-viewing; 96.5% reported they would recommend VS. Of 11 health workers interviewed, 82% preferred VS over SOC; 91% found VS more time-efficient. Compared to SOC, VS group had greater change in HIV/ART knowledge (p < 0.01), trend towards being more likely to start ART (p = 0.07), and better self-reported adherence (p = 0.02). There were no significant group differences in 1-month retention and pharmacy pill count. VITAL Start was highly acceptable, feasible, with promising benefits to ART adherence.",2019,"Compared to SOC, VS group had greater change in HIV/ART knowledge (p < 0.01), trend towards being more likely to start ART (p = 0.07), and better self-reported adherence (p = 0.02).","['Pregnant Women Living with HIV', '306 pregnant women eligible for ART, 160 were randomized to standard of care (SOC), 146 to VS and followed for one-month']","['Novel Video-Based Approach to HIV Counseling', 'video-based intervention targeting HIV-positive pregnant women to optimize antiretroviral therapy (ART) retention and adherence by providing a VITAL Start (Video-intervention', 'Video-Based Intervention']","['HIV/ART knowledge', '1-month retention and pharmacy pill count']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",306.0,0.154501,"Compared to SOC, VS group had greater change in HIV/ART knowledge (p < 0.01), trend towards being more likely to start ART (p = 0.07), and better self-reported adherence (p = 0.02).","[{'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA. mhkim@bcm.edu.""}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Tapiwa', 'Initials': 'T', 'LastName': 'Tembo', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sabelli', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flick', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'University of Texas Medical Branch at Galveston, Galveston, USA.'}, {'ForeName': 'Alick', 'Initials': 'A', 'LastName': 'Mazenga', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Le Blond', 'Affiliation': 'In Tune for Life, 6A West Bank, London, N16 5DG, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Hartig', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wetzel', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Nyirenda', 'Affiliation': 'HIV Unit, Malawi Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Kazembe', 'Affiliation': ""Baylor College of Medicine International Paediatric AIDS Initiative, Texas Children's Hospital, Houston, USA.""}, {'ForeName': 'Mtisunge', 'Initials': 'M', 'LastName': 'Mphande', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Angella', 'Initials': 'A', 'LastName': 'Mkandawire', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Chitani', 'Affiliation': ""Baylor College of Medicine - Abbott Fund Children's Clinical Centre of Excellence, Private bag B-397, Lilongwe 3, Malawi.""}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia, Mailman School of Public Health and Vagelos College of Physicians & Surgeons, Columbia University, New York, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02634-1']
964,32142135,Hypoalgesic Effects of Aerobic and Isometric Motor Imagery and Action Observation Exercises on Asymptomatic Participants: A Randomized Controlled Pilot Trial.,"OBJECTIVES


The objective was to explore whether action observation (AO) and motor imagery (MI) of aerobic and isometric exercise could induce hypoalgesic responses in asymptomatic individuals compared with placebo observation (PO).
METHODS


A randomized controlled pilot trial was designed. Twenty-four healthy participants (mean age = 21.9 ± 2.1 years) were randomized into three groups: AO+MI (N = 8), AO, (N = 8), and PO (N = 8). All participants performed an actual aerobic running exercise (three series of 90 seconds at 85% of their VO2max and 30 seconds at 65% of their VO2max) and an isometric exercise protocol (isometric squats). A day later, they all performed the mental intervention, observing or imagining exercise execution performed the day before, according to their allocated group. Pressure pain thresholds (PPTs) of the quadriceps and epicondyle regions were assessed at baseline, postintervention, and 15 minutes postintervention.
RESULTS


Analysis of variance revealed statistically significant differences in the group*time interaction for PPT in the quadriceps. The AO group showed a statistically significant increase at postintervention and at 15 minutes postintervention. The AO+MI group obtained a statistically significant increase in the two PPT regions compared with the PO group at Δpre-post. The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
CONCLUSIONS


AO and MI induce hypoalgesic responses compared with PO. AO isolated training showed pain modulation responses in the PPTs of the quadriceps region in young physically active adults. These findings highlight the potential role of brain training in pain management.",2020,"The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
","['young physically active adults', 'Twenty-four healthy participants (mean age = 21.9\u2009±\u20092.1 years', 'Asymptomatic Participants', 'asymptomatic individuals compared with placebo observation (PO']","['isometric exercise protocol (isometric squats', 'action observation (AO) and motor imagery (MI) of aerobic and isometric exercise', 'brain training', 'Aerobic and Isometric Motor Imagery and Action Observation Exercises', 'actual aerobic running exercise', 'AO isolated training']","['Pressure pain thresholds (PPTs) of the quadriceps and epicondyle regions', 'pain modulation responses', 'hypoalgesic responses']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",24.0,0.0463063,"The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Fernández Pérez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martínez García', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'López-de-Uralde-Villanueva', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa015']
965,31856495,A prospective comparison of the efficacy of 0.5% bupivacaine vs 0.75% ropivacaine in peribulbar anesthesia for vitreoretinal surgery.,"Purpose


To date, there is no information on the comparison of the effect of 0.5% bupivacaine with 0.75% ropivacaine solution for vitreoretinal surgery.
The aim of the study was to


compare the efficacy of 0.5% bupivacaine with 0.75% ropivacaine in peribulbar anesthesia for vitreoretinal surgery. This was a prospective randomized double-blinded observational study in a hospital setting. Sixty patients planned for vitreoretinal surgery were randomized into two groups based on the peribulbar injection administered either with 0.5% bupivacaine or 0.75% ropivacaine solution, as Group B (n = 30) and Group R (n = 30), respectively. Time of onset of analgesia, akinesia, and the need for supplemental anesthesia were noted. Student's t-test or Mann-Whitney U test were used for comparing continuous variables and Chi-square or a Fischer exact test were used as appropriate for comparing two proportions.
Results


The patients in Group R showed an earlier onset of both, analgesia (1.97 min vs. 2.10 min, P = 0.002) and akinesia (2.77 min vs. 4.20 min, P < 0.001) compared with the patients in Group B. The efficacy of the block attained was Grade 5 (adequate anesthesia and akinesia without supplementation) in about 97% of the patients in Group R while only 90% in Group B. However, the differences between the groups for the efficacy of the block were not statistically significant (P = 0.301) neither for Grades 5 nor for Grade 4 and 3 (P = 1.00 for both). The onset of postoperative pain was similar for both groups (P = 1.00).
Conclusion


We concluded that 0.75% ropivacaine is a better choice of local anesthetic solution for patients undergoing primary vitreoretinal surgery compared with 0.5% bupivacaine.",2020,"However, the differences between the groups for the efficacy of the block were not statistically significant (P = 0.301) neither for Grades 5 nor for Grade 4 and 3 (P = 1.00 for both).","['peribulbar anesthesia for vitreoretinal surgery', 'patients undergoing primary vitreoretinal surgery', 'Sixty patients planned for vitreoretinal surgery']","['ropivacaine solution', 'peribulbar injection administered either with 0.5% bupivacaine or 0.75% ropivacaine solution', 'ropivacaine', 'bupivacaine']","['Time of onset of analgesia, akinesia, and the need for supplemental anesthesia', 'earlier onset of both, analgesia', 'onset of postoperative pain', 'akinesia']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",60.0,0.0662416,"However, the differences between the groups for the efficacy of the block were not statistically significant (P = 0.301) neither for Grades 5 nor for Grade 4 and 3 (P = 1.00 for both).","[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Jaichandran', 'Affiliation': 'Department of Anesthesiology, Sankara Nethralaya, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Vision Research Foundation, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Raman', 'Affiliation': 'Department of Anesthesiology, Sankara Nethralaya, Chennai, Tamil Nadu, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jagadeesh', 'Affiliation': 'Department of Anesthesiology, Sankara Nethralaya, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': 'Shri Bhagwan Mahavir Vitreoretinal Services, Chennai, Tamil Nadu, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_239_19']
966,31856493,Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.,"Purpose


To compare the efficacy of subthreshold micropulse yellow laser (SMYL) and intravitreal aflibercept injection (IAI) combination therapy with IAI monotherapy in the treatment of diabetic macular edema (DME) and to evaluate the number of injections and SMYL sessions required.
Methods


This prospective study compared a group of 28 patients treated with a combination of SMYL and IAI with a group of 28 patients treated only with IAI. All patients initially received 3 monthly IAIs, and the monotherapy group was given additional injections as needed. The combination therapy patients additionally received SMYL after the loading phase. The primary outcome measures were the change in the best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to month 12; the secondary outcomes were the mean number of required injections and SMYL sessions.
Results


In the monotherapy group, the BCVA improved from 0.38 ± 0.10 to 0.20 ± 0.10 logMAR; in the combination group, BCVA improved from 0.40 ± 0.09 to 0.17 ± 0.06 logMAR at the end of the 12 th  month. The CMT was reduced from 451.28 ± 44.85 to 328.8 ± 49.69 μm in the monotherapy group and from 466.07 ± 71.79 to 312.0 ± 39.29 μm in the combination group. Improvement of the mean BCVA and reduction of the mean CMT were similar in each group. The combination group required significantly fewer injections (3.21 ± 0.41 vs 5.39 ± 1.54; P < 0.001). By month 12, 75% of patients in the monotherapy group had required additional IAIs when compared with 16% in the combination group (P < 0.001).
Conclusion


SMYL combination therapy demonstrated significant visual improvements in patients with DME. In the combination group, the retreatment rate and number of required injections were significantly lower compared with the IAI monotherapy group.",2020,The combination group required significantly fewer injections (3.21 ± 0.41 vs 5.39 ± 1.54; P < 0.001).,"['patients with DME', 'diabetic macular edema', '28 patients treated with a combination of SMYL and IAI with a group of 28 patients treated only with IAI', 'diabetic macular edema (DME']",['subthreshold micropulse yellow laser (SMYL) and intravitreal aflibercept injection (IAI) combination therapy with IAI monotherapy'],"['change in the best-corrected visual acuity (BCVA) and central macular thickness (CMT', 'additional IAIs', 'retreatment rate and number of required injections', 'visual improvements', 'mean number of required injections and SMYL sessions', 'mean BCVA and reduction of the mean CMT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1289897', 'cui_str': 'Yellow laser'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0506012,The combination group required significantly fewer injections (3.21 ± 0.41 vs 5.39 ± 1.54; P < 0.001).,"[{'ForeName': 'Hatice Selen', 'Initials': 'HS', 'LastName': 'Kanar', 'Affiliation': 'Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysu', 'Initials': 'A', 'LastName': 'Arsan', 'Affiliation': 'Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Altun', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Suat Fazıl', 'Initials': 'SF', 'LastName': 'Akı', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Hacısalihoglu', 'Affiliation': 'Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_350_19']
967,32496604,Response of preterm infants with transient hypothyroxinaemia of prematurity to the thyrotropin-releasing hormone stimulation test is characterized by a delayed decrease in thyroid-stimulating hormone after the peak.,"OBJECTIVES


We evaluated the response to the thyrotropin-releasing hormone (TRH) stimulation test in very low-birth weight (VLBW) infants to elucidate the aetiology of transient hypothyroxinaemia of prematurity (THOP).
DESIGN AND METHODS


We performed TRH stimulation tests on 43 VLBW infants. Subjects were divided into two groups; a THOP group (N = 11; basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a non-THOP group (N = 32; basal TSH < 15 mU/L and basal FT4 > 0.8 ng/dL). Basal FT4 and FT3 were measured before, and TSH (0, 30, 60, 90, 120 and 180 minutes) was measured after, the administration of TRH (7 µg/kg). We calculated the ratio of TSH 180 minutes to THS 0 minute as the primary outcome. We also collected data on T3 and rT3 in this study.
RESULTS


In both groups, TSH 30 minutes values were the highest. However, the ratios of TSH 180 minutes to THS 0 minutes in the non-THOP group and the THOP group were (median [IQR]) 1.3 [1.0-1.7] and 3.0 [1.5-5.3] (P < .01). No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, P = .06). However, in the THOP group, rT3 was significantly lower than that of the non-THOP group (168.0 [148.1-197.0] and 92.9 [74.7-101.6] pg/mL, P < .01).
CONCLUSIONS


The delayed decrease in the TSH concentration after the peak for the TRH tests and decreased levels of rT3 suggest that the main aetiology for THOP is suppression at the level of the hypothalamus, but not inactivation of peripheral thyroid hormone metabolism.",2020,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","['preterm infants with transient hypothyroxinemia of prematurity', 'very low birth weight (VLBW) infants', '43 VLBW infants']","['basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a Non-THOP group (N=32; basal TSH', 'THOP', 'thyrotropin-releasing hormone (TRH) stimulation test', 'basal FT4']","['Basal FT4 and FT3', 'rT3', 'TSH concentration']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040162', 'cui_str': 'Thyrotropin-Releasing Hormone'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0682753,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kogoro', 'Initials': 'K', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukura', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Niwa', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takita', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Clinical endocrinology,['10.1111/cen.14260']
968,32496397,Early Inflammatory Measures and Neurodevelopmental Outcomes in Preterm Infants.,"BACKGROUND


Inflammation may be an important predictor of long-term neurodevelopment in preterm infants. The identification of specific inflammatory biomarkers that predict outcomes is an important research goal.
OBJECTIVES


The purpose of this analysis was to identify associations between an early measure of inflammation and neurodevelopment in very preterm infants and to identify differences in the relationship between inflammation and neurodevelopment based on infant gender and race.
METHODS


We conducted a secondary analysis of data from a randomized controlled trial of a caregiving intervention for preterm infants born less than 33 weeks postmenstrual age. Plasma was collected with a clinically indicated laboratory draw by neonatal intensive care unit nurses and analyzed by multiplex assay for cytokines, chemokines, and growth factors. Neurobehavior was assessed by research nurses at the time of discharge from the neonatal intensive care unit using the motor development and vigor and alertness/orientation clusters from the Neurobehavioral Assessment of the Preterm Infant. Neurodevelopment was assessed at 6 months corrected age by the developmental specialist in the hospital's neonatal follow-up clinic using the Bayley Scales of Infant Development, Third Edition. We used linear regressions to estimate the effect of cytokine levels on neurodevelopment and allowed the effects to differ by infant gender and race.
RESULTS


In a sample of 62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with 6-month neurodevelopmental assessments, we found inconsistent associations between single-time point inflammatory measures and neurobehavior or neurodevelopment in analyses of the total sample. However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant gender and race.
DISCUSSION


Although early single-time point measures of inflammation may be insufficient to predict neurodevelopment for all preterm infants, the effect of inflammation appears to differ by infant gender and race. These demographic factors may be important considerations for future studies of inflammation and neurodevelopment as well was the development of future interventions to optimize outcomes.",2020,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","['very preterm infants', 'preterm infants born less than 33 weeks post-menstrual age', 'preterm infants', '62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments']",['caregiving intervention'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],62.0,0.0941311,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","[{'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': 'Marliese Dion Nist, PhD, RNC-NIC, is Postdoctoral Scholar, The Ohio State University College of Nursing, Columbus. Abigail B. Shoben, PhD, is Associate Professor, Division of Biostatistics, The Ohio State University College of Public Health, Columbus. Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Endowed Professor of Child and Adolescent Health, The Ohio State University College of Nursing, Columbus.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': ''}, {'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000448']
969,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024']
970,31527670,Open-label placebos reduce test anxiety and improve self-management skills: A randomized-controlled trial.,"Test anxiety is a condition in which people experience extreme distress and anxiety before and in test situations. It affects up to 40 percent of all students. Conventional treatment includes both medication and psychotherapy, but studies also demonstrated that placebos affect anxiety symptoms. Although in the traditional understanding placebos need to be administered in a concealed way, intriguing new studies report that open-label placebos can be effective. Since prescription of fake pills involves ethical problems, open-label placebos may provide important new treatment possibilities. Here we report results of a pilot study examining whether open-label placebos may reduce test anxiety and improve self-management skills. 58 students participated in a two-group randomized controlled trial. Two weeks before an exam at the university participants received open-label placebos or no pills (control group). Participant - provider relationship and amount of contact time was held similar for all groups. After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group. Thus, our results seems to indicate that open-label placebos may reduce test anxiety and enhance self-management skills in students.",2019,After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group.,"['students', '58 students']","['open-label placebo', 'open-label placebos or no pills (control group', 'open-label placebos', 'Open-label placebos', 'placebos']","['test anxiety and self-management abilities (skills and resources', 'test anxiety and improve self-management skills', 'anxiety symptoms', 'test anxiety and enhance self-management skills']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0496191,After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany. michael.schaefer@medicalschool-berlin.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Denke', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Harke', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Olk', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkovan', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Enge', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}]",Scientific reports,['10.1038/s41598-019-49466-6']
971,32493344,"Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial.","BACKGROUND


Endothelial Progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Cellular mechanisms of DPP4 inhibitors such as linagliptin (LG) on CVD risk, in patients with T2DM with established CKD has not been established. Linagliptin, a DPP4 inhibitor when added to insulin, metformin or both may improve endothelial dysfunction in a diabetic kidney disease (DKD) population.
METHODS


31 subjects taking metformin and/or Insulin were enrolled in this 12 weeks, double blind, randomized placebo matched trial, with 5 mg LG compared to placebo. Type 2 diabetes subjects (30-70 years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included. CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition were measured. Data were collected at week 0, 6 and 12. A mixed model regression analysis was done with p value < 0.05 considered significant.
RESULTS


A double positive CD34/CD184 cell count had a statistically significant increase (p < 0.02) as determined by flow cytometry in LG group where CD184 is SDF1a cell surface receptor. Though mRNA differences in CD34+ve was more pronounced CD34- cell mRNA analysis showed increase in antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3). Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group. A reduction in LDL: HDL ratio was noted in treatment group (p < 0.04). Urinary exosome protein examining podocyte health (podocalyxin, Wilms tumor and nephrin) showed reduction or improvement.
CONCLUSIONS


In DKD subjects, Linagliptin promotes an increase in CXCR4 expression on CD34 + progenitor cells with a concomitant improvement in vascular and renal parameters at 12 weeks. Trial Registration Number NCT02467478 Date of Registration: 06/08/2015.",2020,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"['patients with T2DM with established CKD', 'Type 2 diabetes subjects (30-70\xa0years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included', '31 subjects taking', 'type 2 diabetes subjects with chronic kidney disease taking']","['Linagliptin', 'linagliptin (LG', 'metformin', 'Endothelial Progenitor cells (EPCs', 'metformin and/or insulin', 'placebo']","['Arterial stiffness measures such as augmentation Index (AI', 'LDL: HDL ratio', 'endothelial dysfunction', 'CXCR4 expression', 'CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition', 'pulse wave analysis (PWV', 'antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3', 'CD34+ve endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C2316401', 'cui_str': 'Chronic kidney disease stage 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.207918,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"[{'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Cleyton C', 'Initials': 'CC', 'LastName': 'Domingues', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Dore', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Neeki', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Safai', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Magan', 'Initials': 'M', 'LastName': 'Fosso', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01046-z']
972,32196108,"High-Dose Intravenous Immunoglobulin Is Effective Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled Trial: Comments.",,2020,,[],"['Placebo', 'Immunoglobulin']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]",[],,0.71449,,"[{'ForeName': 'Tze Chao', 'Initials': 'TC', 'LastName': 'Wee', 'Affiliation': 'Department of Rehabilitation Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Yeow Leng', 'Initials': 'YL', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, Singapore General Hospital, Singapore.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa057']
973,32418886,Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study.,"BACKGROUND


The ALEX study demonstrated significantly improved progression-free survival (PFS) with alectinib versus crizotinib in treatment-naive ALK-positive non-small-cell lung cancer (NSCLC) at the primary data cut-off (9 February 2017). We report mature PFS (cut-off: 30 November 2018) and overall survival (OS) data up to 5 years (cut-off: 29 November 2019).
PATIENTS AND METHODS


Patients with stage III/IV ALK-positive NSCLC were randomized to receive twice-daily alectinib 600 mg (n = 152) or crizotinib 250 mg (n = 151) until disease progression, toxicity, withdrawal or death. Primary end point: investigator-assessed PFS. Secondary end points included objective response rate, OS and safety.
RESULTS


Mature PFS data showed significantly prolonged investigator-assessed PFS with alectinib [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.32-0.58; median PFS 34.8 versus 10.9 months crizotinib]. Median duration of OS follow-up: 48.2 months alectinib, 23.3 months crizotinib. OS data remain immature (37% of events). Median OS was not reached with alectinib versus 57.4 months with crizotinib (stratified HR 0.67, 95% CI 0.46-0.98). The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 8.6% of patients still on study treatment, respectively. The OS benefit of alectinib was seen in patients with central nervous system metastases at baseline [HR 0.58 (95% CI 0.34-1.00)] and those without [HR 0.76 (95% CI 0.45-1.26)]. Median treatment duration was longer with alectinib (28.1 versus 10.8 months), and no new safety signals were observed.
CONCLUSIONS


Mature PFS data from ALEX confirmed significant improvement in PFS for alectinib over crizotinib in ALK-positive NSCLC. OS data remain immature, with a higher 5-year OS rate with alectinib versus crizotinib. This is the first global randomized study to show clinically meaningful improvement in OS for a next-generation tyrosine kinase inhibitor versus crizotinib in treatment-naive ALK-positive NSCLC.
CLINICAL TRIALS NUMBER


NCT02075840.",2020,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","['patients with treatment-naïve advanced ALK-positive non-small-cell lung cancer in the ALEX study', 'patients with central nervous system metastases at baseline (HR 0.58', 'Patients with stage III/IV ALK-positive NSCLC']","['twice-daily alectinib 600 mg (n = 152) or crizotinib', 'alectinib versus crizotinib']","['overall survival (OS) data', 'Median duration of OS', 'Median OS', 'Updated overall survival and final progression-free survival data', 'Median treatment duration', 'objective response rate, OS and safety', '5-year OS rate', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.315613,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, NT, Hong Kong.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado, Denver, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Internal Medicine, Rogel Cancer Center/University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'D-W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'S-H I', 'Initials': 'SI', 'LastName': 'Ou', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bordogna', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Smoljanović', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hilton', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruf', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Noé', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. Electronic address: solange.peters@chuv.ch.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.478']
974,32496902,Impact of Intrathecal Triple Therapy Versus Intrathecal Methotrexate on Disease-Free Survival for High-Risk B-Lymphoblastic Leukemia: Children's Oncology Group Study AALL1131.,"PURPOSE


The high-risk stratum of Children's Oncology Group Study AALL1131 was designed to test the hypothesis that postinduction CNS prophylaxis with intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine would improve the postinduction 5-year disease-free survival (DFS) compared with intrathecal methotrexate (IT MTX), when given on a modified augmented Berlin-Frankfurt-Münster backbone.
PATIENTS AND METHODS


Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction were randomly assigned to receive postinduction IT MTX or ITT. Patients with CNS3-status disease were not eligible. Postinduction IT therapy was given for a total of 21 to 26 doses. Neurocognitive assessments were performed during therapy and during 1 year off therapy.
RESULTS


Random assignment was closed to accrual in March 2018 after a futility boundary had been crossed, concluding that ITT could not be shown to be superior to IT MTX. The 5-year postinduction DFS and overall survival rates (± SE) of children randomly assigned to IT MTX versus ITT were 93.2% ± 2.1%  v  90.6% ± 2.3% ( P  = .85), and 96.3% ± 1.5%  v  96.7% ± 1.4% ( P  = .77), respectively. There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT. There were no significant differences in neurocognitive outcomes for patients receiving IT MTX compared with ITT.
CONCLUSION


Postinduction CNS prophylaxis with ITT did not improve 5-year DFS for children with HR B-ALL. The standard of care for CNS prophylaxis for children with B-ALL and no overt CNS involvement remains IT MTX.",2020,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","['children with B-ALL and no overt CNS involvement remains IT MTX', 'Patients with CNS3-status disease', 'Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction']","['Intrathecal Methotrexate', 'postinduction IT MTX or ITT', 'IT MTX', 'Intrathecal Triple Therapy', 'intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine', 'intrathecal methotrexate (IT MTX']","['cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities', 'neurocognitive outcomes', '5-year DFS', 'postinduction 5-year disease-free survival (DFS', '5-year postinduction DFS and overall survival rates (± SE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0686377', 'cui_str': 'Secondary malignant neoplasm of central nervous system'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0503645,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","[{'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'Uniformed Services University, Bethesda, MD.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burke', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Hardy', 'Affiliation': ""Children's National Medical Center, Washington, DC.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kairalla', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Department of Pediatrics, Maine Children's Cancer Program, Scarborough, ME.""}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-McKay', 'Affiliation': 'ImmunoGen, Inc, Waltham, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02892']
975,32502876,Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study.,"BACKGROUND


Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.
METHODS


QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.
RESULTS


Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.
CONCLUSIONS


In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients.
CLINICAL TRIAL REGISTRATION


NCT01578499.",2020,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"['patients with relapsed/refractory cutaneous T-cell lymphoma', 'adult patients with CD30-expressing\xa0cutaneous T-cell lymphoma treated with prior']","[""physician's choice (methotrexate/bexarotene"", 'Cancer Therapy-General', 'European QoL 5-dimension', 'systemic therapy']","['quality of life', 'Skindex-29 symptom domain', 'FACT-G and EQ-5D QoL scores', 'Quality of life (QoL', 'EQ-5D changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0054950', 'cui_str': 'Lymphocyte antigen CD30'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.118026,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': ""Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Whittaker', 'Affiliation': 'Division of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, Kings College London & Guys and St Thomas NHS Foundation Trust, London, UK. Electronic address: sean.whittaker@gstt.nhs.uk.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG.'}, {'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Scarisbrick', 'Affiliation': 'Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: Julia.Scarisbrick@uhb.nhs.uk.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Seràgnoli"", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wolter', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: Heradat@mednet.ucla.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pinter-Brown', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Sanches', 'Affiliation': 'Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org.'}, {'ForeName': 'Oleg E', 'Initials': 'OE', 'LastName': 'Akilov', 'Affiliation': 'University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Geskin', 'Affiliation': 'Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu.'}, {'ForeName': 'Auris', 'Initials': 'A', 'LastName': 'Huen', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lisano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com.'}, {'ForeName': 'Akshara', 'Initials': 'A', 'LastName': 'Richhariya', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Bunn', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Zagadailov', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com.'}, {'ForeName': 'Mehul R', 'Initials': 'MR', 'LastName': 'Dalal', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.010']
976,32511774,Dietary sodium intake and cortisol measurements.,"OBJECTIVES


To assess the influence of a dietary sodium intake intervention on cortisol measurements within the general population.
DESIGN


Cross-over intervention.
PATIENTS


Six hundred thirty adults without known Cushing syndrome, cardiovascular or renal disease completed a restricted dietary sodium diet (10 mmol/d, 230 mg/d) followed by cross-over to a liberalized dietary sodium diet (200 mmol/d, 4600 mg/d). Twenty-four-hour urine collection and biochemical investigations were performed at the end of each dietary intervention.
RESULTS


Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs 121.3 ± 65.6 nmol/d, P < .001). Nearly all participants (84%) had an increase in the urinary free cortisol following liberalized sodium intake. This translated to a substantial difference in the proportion of participants exceeding categorical thresholds of urinary cortisol on liberalized vs restricted sodium intake: 62% vs 27% for 138 nmol/d (50 mcg/d), 46% vs 17% for 166 nmol/d (60 mcg/d), 32% vs 10% for 193 nmol/d (70 mcg/d), 23% vs 6% for 221 nmol/d (80 mcg/d), 17% vs 4% for 248 nmol/d (90 mcg/d). In parallel, there was a small decrease in morning total serum cortisol with liberalized sodium intake (303.0 ± 117.3 vs 326.4 ± 162.5 nmol/L, P < .001).
CONCLUSIONS


Increased dietary sodium intake increases urinary free cortisol excretion and may increase the risk for false-positive results. Variations in dietary sodium intake may influence the interpretations of cortisol measurements performed to evaluate for hypercortisolism.",2020,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","['630 adults without known Cushing syndrome, cardiovascular or renal disease completed a']","['restricted dietary sodium diet (10 mmol/day, 230 mg/day) followed by cross-over to a liberalized dietary sodium diet', 'dietary sodium intake intervention']","['Mean 24-hour urinary free cortisol', 'Dietary Sodium Intake and Cortisol Measurements', 'morning total serum cortisol', 'urinary free cortisol', 'cortisol measurements']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439433', 'cui_str': 'mmol/24h'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}]",630.0,0.0210742,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrea V', 'Initials': 'AV', 'LastName': 'Haas', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical endocrinology,['10.1111/cen.14262']
977,32516270,"Crossover associations of alcohol and smoking, craving and biochemically verified alcohol and nicotine use in heavy drinking smokers.","This study examined associations between drinking and smoking prior to treatment (biochemically measured at baseline), alcohol and tobacco craving, and biochemical alcohol and tobacco use during the analog trial period. We conducted a secondary data analysis of a randomized clinical analog trial where participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited. A generalized estimation equation model for longitudinal binary outcomes was created (N = 34) to determine the predictive effects of baseline tobacco use, alcohol craving, and tobacco craving on alcohol use over the 4 weeks of the trial. Baseline smoking was significantly (*p < 0.05) associated with drinking over time [odds ratio (OR) = 3.09*], while baseline drinking was associated with smoking (OR = 4.17*). Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92*, respectively) but were negatively associated with alcohol use over time (OR = 0.79* and OR = 0.57*, respectively). Heavier use of either tobacco or alcohol preceding treatment may require more intensive interventions in order to reduce tobacco and alcohol use. Future trials designed to address mechanisms of behavior change in the context of novel treatments could promote a better understanding of the cross-rewarding effects related to the co-use of these substances and lead to the development of more integrated and appropriately intense treatments for individuals with concomitant tobacco and alcohol use disorders.",2020,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"['individuals with concomitant tobacco and alcohol use disorders', 'heavy drinking smokers', 'participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited']",['tobacco or alcohol'],"['Baseline alcohol and tobacco craving', 'alcohol and tobacco craving, and biochemical alcohol and tobacco use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]",,0.0128751,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"[{'ForeName': 'Crystal Lederhos', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Jenkins', 'Affiliation': 'Prevention Science.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Burduli', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Tham', 'Affiliation': 'Elson S. Floyd College of Medicine.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Miguel', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'Mcpherson', 'Affiliation': 'Program of Excellence in Addictions Research.'}]",Behavioural pharmacology,['10.1097/FBP.0000000000000568']
978,32496821,A test of a resilience based intervention for mental health problems in Iraqi internally displaced person camps.,"Background and Objectives:  The mental health needs of those in internally displaced persons camps are significant and are compounded by a number of barriers to care. Traditional methods of mental health care are often not feasible and thus a need exists for interventions that can successfully meet these conditions. The current study introduces and tests a new positive-psychology intervention, GROW, which was designed specifically for use in internally displaced persons camps.  Design:  Pre-Post-Follow-up longitudinal examination of those who participated in the GROW intervention group ( N  = 766).  Methods:  The study includes three waves of data for the intervention, which was administered in a group format, using paraprofessionals, over a two-week period in internally displaced persons camps in Iraq.  Results:  The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up. Post hoc results indicated participants who were older, female, or who attended more sessions were more likely to respond to the intervention.  Conclusions:  These data provide initial support for the intervention and suggest additional research to more fully validate this intervention are warranted.",2020,The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up.,['mental health problems in Iraqi internally displaced person camps'],['GROW intervention'],['symptoms of PTSD'],"[{'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C5197839', 'cui_str': 'Internally Displaced Persons'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",,0.0256564,The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up.,"[{'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, Bethel University, St Paul, MN.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Gaede', 'Affiliation': 'Tutapona, New Richmond, WI.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1773446']
979,32496835,Does person-centred care improve outcomes for musicians fitted with hearing protectors?,"Objective:  To reduce the risk of hearing injury, musicians are often recommended custom-made musicians' hearing protectors (MHP). Studies report benefits of use however, many still report challenges leading to relatively low uptake and inconsistent usage. Person-centred approaches to health have been shown to improve patient outcomes, and these principles may be translatable to musicians' hearing care. The aim was to investigate if use of, and satisfaction with, MHP is influenced by the treatment delivered to musicians by audiologists. Design:  Participants were randomly allocated to one of four conditions that varied in extent of person-centred care. Study sample:  Forty-two musicians with an interest in purchasing MHP were recruited. Results:  Satisfaction with MHP was high overall and users reported a reduction in incidence of tinnitus. Participants reported few issues related to sound quality, however insertion difficulty was the main problem reported. Only one musician self-identified the need for alterations to their MHP. Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions. Most often, the need for MHP alterations were clinician-identified during fitting appointments or follow-up contact, underscoring the importance of including these components when providing audiological services to musicians.",2020,"Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.",['Study sample:  Forty-two musicians with an interest in purchasing MHP were recruited'],['MHP'],['incidence of tinnitus'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]",42.0,0.0491183,"Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.","[{'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McGinnity', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth Francis', 'Initials': 'EF', 'LastName': 'Beach', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Mulder', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Barr', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1771621']
980,32507672,"Corrigendum to 'Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE)': Annals of Oncology, Volume 31, Issue 1, 2020, Pages 79-87.",,2020,,"['2020, Pages 79-87']","['istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine', 'placebo']",[],"[{'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}]","[{'cui': 'C3641662', 'cui_str': 'MM-141'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0987186,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundranda', 'Affiliation': 'Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Gracian', 'Affiliation': 'Medical Oncology, Centro Integral Oncologico Clara Campal, Universidad CEU San Pablo, Madrid, Spain; Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, Madrid, Spain.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Zafar', 'Affiliation': 'Hematology and Oncology, Florida Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meiri', 'Affiliation': 'Medical Oncology, Comprehensive Care and Research Center, Atlanta, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'TUM School of Medicine, Klinikum rechts der Isar, Medizinische Klinik II, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Ahn', 'Affiliation': 'Medical Oncology, Cancer Treatment Centers of America Chicago, Zion, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Charu', 'Affiliation': 'Hematology/Oncology, Pacific Cancer Medical Center, Anaheim, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zalutskaya', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kuesters', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Pipas', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santillana', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Askoxylakis', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Hematology/Oncology, University of California San Francisco Cancer Center, San Francisco, USA. Electronic address: andrew.ko@ucsf.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.011']
981,32510111,Effects of Health Risk Assessment and Counselling on Fruit and Vegetable Intake in Older People: A Pragmatic Randomised Controlled Trial.,"OBJECTIVES


Interventions to increase fruit and vegetable intake among community-dwelling older people have shown mixed effects. We investigated whether an intervention based on an initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling has favourable effects on dietary intake among community-dwelling older people.
DESIGN


Randomised controlled trial comparing the intervention versus usual care.
SETTING AND PARTICIPANTS


Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups.
INTERVENTION


Participants received a computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption.
MEASUREMENTS


Fruit and vegetable intake at baseline and at 6-month follow-up.
RESULTS


At baseline, fruit and vegetable intake was below the recommended five portions per day in most study participants (85% in the intervention group, and 86% among controls, respectively). At six months, intake increased in the intervention group from a median of 3.8 to 4.6 portions per day, and decreased in the control group due to a seasonal effect from a median of 3.8 to 3.1 portions per day. At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls (median difference 1.4 portions per day, 95% confidence interval 1.1-1.7, p<0.001).
CONCLUSION


Personalised food-based dietary guidance, delivered as part of multidimensional preventive health counselling during geriatric clinic visits, results in relevant improvement of fruit and vegetable intake in community-dwelling older adults.",2020,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","['Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups', 'community-dwelling older adults', 'community-dwelling older people', 'Older People']","['Health Risk Assessment and Counselling on Fruit and Vegetable Intake', 'computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption', 'initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling']","['Fruit and vegetable intake', 'fruit and vegetable consumption', 'fruit and vegetable intake']","[{'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0373016,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Herghelegiu', 'Affiliation': 'Andreas Ernst Stuck, Department of Geriatrics, Inselspital, University Hospital Bern, and University of Bern, Bern, Switzerland, andreas.stuck@insel.ch.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moser', 'Affiliation': ''}, {'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Prada', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Nuta', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Stuck', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1373-9']
982,31519975,Identification and injury to the inferior hypogastric plexus in nerve-sparing radical hysterectomy.,"Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study. However, the definite reasons for these results were unknown. This subgroup analysis compared the neural areas and impairment in the IHP uterine branches harvested during NSRH as an alternative to the IHP vesical branches between the waterjet and control groups. This study included samples from 30 eligible patients in each group of the trial NCT03020238. At least one specimen from each side of the IHP uterine branches was resected. The tissues were scanned, images were captured, and the neural component areas were calculated using the image segmentation method. Immunohistochemical staining was used to evaluate neural impairment. The control and waterjet groups had similar areas of whole tissues sent for evaluation. However, the control group had significantly fewer areas (median 272158 versus 200439 μm 2 , p = 0.044) and a lower percentage (median 4.9% versus 3.0%, p = 0.011) of neural tissues. No significant changes in immunohistochemical staining were found between the two groups. For patients with residual urine ≤100 and >100 ml at 14 days after NSRH (42 and 18 patients, respectively), there were significantly different percentages of neural tissues in the resected samples (p < 0.001). Hence, Due to the accurate identification of IHP during NSRH, the waterjet dissection technique achieved better urodynamic results.",2019,Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study.,"['nerve-sparing radical hysterectomy', '30 eligible patients in each group of the trial NCT03020238']","['Immunohistochemical staining', 'Waterjet dissection of the inferior hypogastric plexus (IHP', 'laparoscopic nerve-sparing radical hysterectomy (NSRH']","['immunohistochemical staining', 'neural tissues']","[{'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0205797', 'cui_str': 'Pelvic Plexus'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}]","[{'cui': 'C0487602', 'cui_str': 'Staining'}]",,0.0323975,Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Yalan', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Xuanwu Hospital, Capital Medical University, 45# Changchun Street, Beijing, 100053, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kraemer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tuebingen, Calwerstr. 7, Tübingen, 72076, Germany.'}, {'ForeName': 'Jinghe', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Quancai', 'Initials': 'Q', 'LastName': 'Cui', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China. cuiqc@sina.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China. wuming@pumch.cn.'}]",Scientific reports,['10.1038/s41598-019-49856-w']
983,31162829,"Disease Activity, Antineutrophil Cytoplasmic Antibody Type, and Lipid Levels in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.","OBJECTIVE


Patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) have an elevated risk of cardiovascular disease (CVD). This study was undertaken to develop a clearer understanding of the association between changes in disease activity and lipid levels in AAV, which may inform CVD risk stratification in this population.
METHODS


Lipid levels were assessed in stored serum samples (obtained at baseline and month 6) from the Rituximab for ANCA-Associated Vasculitis (RAVE) trial, which randomized patients to receive either rituximab or cyclophosphamide followed by azathioprine. Paired t-tests and multivariable linear regression were used to assess changes in lipid levels.
RESULTS


Of the 142 patients with serum samples available, the mean ± SD age was 52.3 ± 14.7 years, 72 (51%) were male, 95 (67%) were proteinase 3 (PR3)-ANCA positive, 72 (51%) had received a new diagnosis of AAV, and 75 (53%) were treated with rituximab. Several lipid levels increased between baseline and month 6, including total cholesterol (+12.4 mg/dl [95% confidence interval (95% CI) +7.1, +21.0]), low-density lipoprotein (+10.3 mg/dl [95% CI +6.1, +17.1]), and apolipoprotein B (+3.5 mg/dl [95% CI +1.0, +8.3]). These changes were observed among newly diagnosed and PR3-ANCA-positive patients but not among those with relapsing disease or myeloperoxidase-ANCA-positive patients. There was no difference in change in lipid levels between rituximab-treated patients and cyclophosphamide-treated patients. Changes in lipid levels correlated with changes in erythrocyte sedimentation rate but not with other inflammatory markers or glucocorticoid exposure.
CONCLUSION


Lipid levels increased during remission induction among patients with newly diagnosed AAV and those who were PR3-ANCA positive. Disease activity and ANCA type should be considered when assessing lipid profiles to stratify CVD risk in patients with AAV.",2019,"Levels of several lipid levels increased between baseline and month 6, including total cholesterol (+12.4mg/dL, [+7.1, +21.0]), low-density lipoprotein (+10.3 mg/dL, [+6.1, +17.1]), and apolipoprotein B (+3.5 mg/dL, [+1.0, +8.3]).","['patients with AAV', '±14.7) years, 72 (51%) were male, 95 (67%) were proteinase (PR3)-ANCA+, 72 (51%) had a new diagnosis of AAV, and 75 (53%) were treated with', '142 subjects with samples available', 'patients with AAV with newly-diagnosed disease and those who are PR3-ANCA', 'Patients with ANCA-associated vasculitis (AAV']","['cyclophosphamide', 'azathioprine', 'rituximab', 'rituximab or cyclophosphamide']","['Lipid levels', 'Levels of several lipid levels', 'total cholesterol', 'Disease Activity, ANCA-Type, and Lipid Levels', 'lipid levels', 'low-density lipoprotein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis (observable entity)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",142.0,0.119725,"Levels of several lipid levels increased between baseline and month 6, including total cholesterol (+12.4mg/dL, [+7.1, +21.0]), low-density lipoprotein (+10.3 mg/dL, [+6.1, +17.1]), and apolipoprotein B (+3.5 mg/dL, [+1.0, +8.3]).","[{'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Wallace', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Liao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Cees G M', 'Initials': 'CGM', 'LastName': 'Kallenberg', 'Affiliation': 'Universiteit Groningen, Groningen, Netherlands.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'VA Boston Health Care System Boston Vet Center, Boston, Massachusetts.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Hyon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41006']
984,32212295,Understanding the results of the PARAGON-HF trial.,,2020,,[],[],[],[],[],[],,0.0198837,,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Centro Cardiologico Universitario di Ferrara, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fucili', 'Affiliation': 'Centro Cardiologico Universitario di Ferrara, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rapezzi', 'Affiliation': 'Centro Cardiologico Universitario di Ferrara, University of Ferrara, Ferrara, Italy.'}]",European journal of heart failure,['10.1002/ejhf.1797']
985,32500569,A randomised controlled trial of fibrinogen concentrate during scoliosis surgery.,"Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg -1  (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.",2020,"Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34.","['scoliosis surgery', '102 children 12-18\xa0years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30']","['fibrinogen concentrate', 'saline placebo']","['Bleeding and blood transfusion', 'allogeneic red blood cell transfusion', 'Fibrinogen reduced peri-operative blood loss']","[{'cui': 'C0854477', 'cui_str': 'Scoliosis surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",11.0,0.601726,"Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopedics Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopedics Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}]",Anaesthesia,['10.1111/anae.15124']
986,32497736,Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study.,"BACKGROUND


We designed an open-label, noncomparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies.
PATIENTS AND METHODS


From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (N = 77) or C-B (N = 76). The primary end point was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary end points included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires), and safety.
RESULTS


Median (range) duration of treatment was 7.8 (6.0-9.7) months and 6.2 (4.1-9.1) months in the TT-B and C-B groups, respectively. Median (range) PFS was 9.2 (7.6-11.6) and 7.8 (5.5-10.1) months, respectively. Median (range) OS was 18 (15.2 to NA) and 16.2 (12.5 to NA) months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ≥3 neutropenia (47% versus 5% with C-B). Patients receiving C-B had more grade ≥3 hand-foot syndrome (12% versus 0% with TT-B) and grade ≥3 diarrhea (8% versus 1% with TT-B), consistent with the known safety profiles of these agents.
CONCLUSION


TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL.
CLINICAL TRIAL INFORMATION


NCT02743221 (ClinicalTrials.gov).",2020,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"['Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy', 'From 29 April 2016 to 29 March 2017', 'untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies', '153 patients']","['Trifluridine/Tipiracil plus Bevacizumab', 'trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B']","['grade ≥3 hand-foot syndrome', 'Median PFS', 'Median OS', 'tolerated', 'overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety', '100 events (radiological progression or death', 'clinical activity', 'grade ≥3 diarrhea', 'safety and efficacy', 'grade ≥3 neutropenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",153.0,0.0974354,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Danielewicz', 'Affiliation': 'Szpitale Wojewodzkie w Gdyni/Gdansk Medical University, Gdynia, Poland.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital Besançon, Besançon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Van de Wouw', 'Affiliation': 'VieCuri Medisch Centrum Noord-Limburg, Venlo, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fedyanin', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital N62, Moscow, Russia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kroening', 'Affiliation': 'Schwerpunktpraxis für Haematologie und Onkologie Hasselbachplatz, Magdeburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Department of Oncology, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanehisa', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Egorov', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aubel', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseenko', 'Affiliation': 'Saint-Petersburg Scientific Practical Center for Specialized Medical Care, St Petersburg, Russia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.024']
987,32502940,"The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial.","BACKGROUND


Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET) can reduce pre-operative tumour burden in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer. This prospective translational study assessed the ability of a 12-gene molecular score (MS; EndoPredict®) to predict response to NaCT or NET within the ABCSG-34 trial.
PATIENTS AND METHODS


Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase II trial were selected and EndoPredict testing was performed to generate a 12-gene MS. ABCSG-34 patients were assigned to receive either NaCT or NET based on menopausal status, HR expression, grade and Ki67. Response was measured by residual cancer burden (RCB).
RESULTS


Patients selected for NaCT generally had high-risk disease by 12-gene MS (125/134), while slightly more patients treated with NET had low-risk disease (44/83). Low-risk NaCT-treated and high-risk NET-treated tumours responded poorly (NPV 100% [95% CI 66.4%-100%] and NPV 92.3% [95% CI 79.1%-98.4%], respectively]. The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
CONCLUSIONS


The 12-gene MS predicted RCB after treatment with neoadjuvant therapies for patients with HR-positive, HER2-negative early-stage breast cancer. Tumours with low MS were unlikely to benefit from NaCT, whereas a high MS predicted resistance to NET. This additional biologic information can aid personalized treatment selection in daily practice and builds a strong rationale to use EndoPredict in biomarker-driven studies in the neoadjuvant setting.",2020,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","['patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer', 'Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase', 'patients with HR-positive, HER2-negative early-stage breast cancer']","['neoadjuvant chemotherapy and neoendocrine therapy', 'NaCT', 'Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET', 'NaCT or NET']","['residual cancer burden (RCB', 'high-risk disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0845297,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breast Center St. Anna, Lucerne, Switzerland. Electronic address: peter.dubsky@hirslanden.ch.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Center, Brustzentrum Kärnten, St. Veit, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinkum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Meek', 'Affiliation': 'Myriad Genetics, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kronenwett', 'Affiliation': 'Myriad International GmbH, Cologne, Germany.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.020']
988,32507027,Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke.,"Background and Purpose . Previous studies suggest that individuals poststroke can achieve substantial gains in walking function following high-intensity locomotor training (LT). Recent findings also indicate practice of variable stepping tasks targeting locomotor deficits can mitigate selected impairments underlying reduced walking speeds. The goal of this study was to investigate alterations in locomotor biomechanics following 3 different LT paradigms.  Methods . This secondary analysis of a randomized trial recruited individuals 18 to 85 years old and >6 months poststroke. We compared changes in spatiotemporal, joint kinematics, and kinetics following up to 30 sessions of high-intensity (>70% heart rate reserve [HRR]) LT of variable tasks targeting paretic limb and balance impairments (high-variable, HV), high-intensity LT focused only on forward walking (high-forward, HF), or low-intensity LT (<40% HRR) of variable tasks (low-variable, LV). Sagittal spatiotemporal and joint kinematics, and concentric joint powers were compared between groups. Regressions and principal component analyses were conducted to evaluate relative contributions or importance of biomechanical changes to between and within groups.  Results . Biomechanical data were available on 50 participants who could walk ≥0.1 m/s on a motorized treadmill. Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV. Resultant principal component analyses were characterized by paretic powers and kinematic consistency following HV, while HF and LV were characterized by nonparetic powers.  Conclusion . High-intensity LT results in greater changes in kinematics and kinetics as compared with lower-intensity interventions. The results may suggest greater paretic-limb contributions with high-intensity variable stepping training that targets specific biomechanical deficits.  Clinical Trial Registration . https://clinicaltrials.gov/ Unique Identifier: NCT02507466.",2020,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","['individuals 18 to 85 years old and >6 months poststroke', '50 participants who could walk ≥0.1 m/s on a motorized treadmill']","['high-intensity variable stepping training', 'High-Intensity Stepping Training', 'https://clinicaltrials.gov']","['locomotor biomechanics', 'Sagittal spatiotemporal and joint kinematics, and concentric joint powers', 'spatiotemporal parameters, kinematic consistency, and kinetics']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",50.0,0.0846158,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Gordhan', 'Initials': 'G', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connolly', 'Affiliation': 'University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320929675']
989,32518932,"Effect of preoperative gabapentin after transurethral prostate resection under general anesthesia. A randomized double-blind, placebo-controlled trial.","OBJECTIVES


To investigate whether preoperative oral gabapentin could reduce postoperative pain, analgesic consumption and the occurrence of catheter-related bladder discomfort (CRBD). Methods: In this study, participants randomly received either 600 mg gabapentin or placebo orally 2 h prior to transurethral prostate resection. Visual analogue scale and Ramsay sedation scale was utilized to assess pain intensity and sedation status after surgery. Intravenous 1.5 mg.kg-1 tramadol was used for postoperative analgesia. Pain intensity, sedation status, CRBD, tramadol consumption, side effects and the overall satisfaction degree were assessed and recorded for 48 h after tracheal extubation.  Results: Ninety participants given gabapentin and 91 participants given placebo completed the study. Lower visual analogue scale scores, less tramadol consumption, longer time to the first analgesic requirement, lower incidence of CRBD and nausea and higher satisfaction degree were detected in the patients receiving gabapentin compared with the patients receiving placebo.  Conclusion: Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.",2020,"Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.","['Ninety participants given', 'transurethral prostate resection under general anesthesia', 'and 91 participants given']","['Intravenous 1.5 mg.kg-1 tramadol', 'gabapentin', 'gabapentin or placebo', 'preoperative gabapentin', 'placebo']","['pain intensity and sedation status', ""postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction"", 'Visual analogue scale and Ramsay sedation scale', 'tramadol consumption, longer time to the first analgesic requirement, lower incidence of CRBD and nausea and higher satisfaction degree', 'postoperative pain, analgesic consumption and the occurrence of catheter-related bladder discomfort (CRBD', 'Pain intensity, sedation status, CRBD, tramadol consumption, side effects and the overall satisfaction degree', 'postoperative analgesia', 'Lower visual analogue scale scores']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",,0.349184,"Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.","[{'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Hospital of Jilin University, Jilin, China. E-mail. wangjinguolily@163.com.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.6.25132']
990,32524297,Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial.,"INTRODUCTION


In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT; ClinicalTrials.gov number NCT01994889), tafamidis reduced the risk of all-cause mortality in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus placebo. Median overall survival was not achieved in either treatment arm (57.1 and 70.5% of patients in the placebo and tafamidis groups, respectively, survived at 30 months), limiting assessment of the potential survival benefits of treatment.
METHODS


A survival extrapolation analysis was conducted following technical support guidelines from the National Institute for Health and Care Excellence. Multiple models (i.e., exponential, Weibull, gamma, log-logistic, log-normal, Gompertz, generalized gamma, and generalized F) were applied to systematically fit different candidate curves to existing patient-level data from the 30-month treatment period in ATTR-ACT. The relative goodness-of-fit for each candidate curve was then tested by Akaike's and Bayesian information criteria to select a single model that was fitted to the placebo and pooled tafamidis treatment arms.
RESULTS


A gamma distribution was selected as best fitting model and fitted to both treatment arms. The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
CONCLUSIONS


This extrapolation of survival data from ATTR-ACT further supports the efficacy of tafamidis in patients with ATTR-CM. Owing to the limitations of this analysis, these survival estimates should be interpreted with caution; however, they are consistent with recently presented findings from a combined analysis of data from ATTR-ACT and interim data from an ongoing long-term extension study (median follow-up 36 months; ClinicalTrials.gov number NCT02791230).
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01994889.",2020,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
","['patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus', 'patients with ATTR-CM', 'Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis']",['placebo'],"['Median overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis'}, {'cui': 'C2745274', 'cui_str': 'tafamidis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.496993,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Pfizer, New York, NY, USA. Benjamin.Li@pfizer.com.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Alvir', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer, Groton, CT, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00179-2']
991,31885300,Effect of metronidazole combined with autolytic debridement for the management of malignant wound malodor.,"OBJECTIVE


To explore the effect of metronidazole combined with autolytic debridement for the management of malignant wound malodor.
METHODS


Patients with malignant wounds who underwent dressing change at a wound outpatient clinic from September 2016 to February 2019 were randomized to an observation group (36 patients) or a control group (37 patients). The observation group was treated with metronidazole combined with debridement gel while the control group received wet dressing therapy combined with silver sulfadiazine. Malodor control was compared between the two groups from treatment initiation to days 3 and 12 after dressing change, and the social impact scale was used to compare stigma caused by malodor between the groups before and after treatment.
RESULTS


The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group. There was no difference in stigma between the two groups before treatment, but stigma in the observation group was significantly lower than that in the control group after treatment.
CONCLUSION


Metronidazole combined with autolytic debridement can effectively reduce the malodor of cancerous wounds while controlling infection, and alleviate patient stigma caused by malodor.",2020,The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group.,"['malignant wound malodor', 'Patients with malignant wounds who underwent dressing change at a wound outpatient clinic from September 2016 to February 2019']","['Metronidazole combined with autolytic debridement', 'metronidazole combined with autolytic debridement', 'metronidazole combined with debridement gel while the control group received wet dressing therapy combined with silver sulfadiazine']","['stigma', 'social impact scale']","[{'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004372', 'cui_str': 'Autolysis'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0162468', 'cui_str': 'Social Impact'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0351736,The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The Journal of international medical research,['10.1177/0300060519889746']
992,31885341,Gradual oculomotor training in blow-out orbital fracture reconstruction recovery.,"OBJECTIVE


This study compared the impact of gradual oculomotor training (GOT) in blow-out orbital fracture (BOF) reconstruction recovery with the impact of high-intensity trainings.
METHODS


In total, 120 patients with BOF requiring orbital reconstruction surgery were randomly divided into four groups; all groups performed postoperative oculomotor training four times per day. Patients in Groups 1, 2, 3, and 4 performed 10, 20, 30, and 50 sets of all-direction movement per training on the first 3 days, respectively; they performed 10 additional sets per training on the following 4 days. Patients in all groups performed 50 sets per training from 8 days to 3 months postoperatively. Incision healing, pain, and satisfaction rate, as well as degree of diplopia, were recorded during follow-up.
RESULTS


At 7 days postoperatively, more patients in Group 1 had no/mild swelling and no/mild pain, compared with patients in Group 4. Patients in Groups 1 and 2 had higher satisfaction rates than patients in Group 4. The degree of diplopia did not significantly differ among the groups.
CONCLUSIONS


For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.",2020,"For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.",['120 patients with BOF requiring orbital reconstruction surgery'],"['postoperative oculomotor training', 'gradual oculomotor training (GOT', 'Gradual oculomotor training']","['wound healing, pain relief, and satisfaction; the degree of diplopia', 'Incision healing, pain, and satisfaction rate, as well as degree of diplopia', 'mild swelling and no/mild pain', 'satisfaction rates', 'degree of diplopia']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0029184', 'cui_str': 'Fracture of orbit'}, {'cui': 'C4761185', 'cui_str': 'Orbital reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",120.0,0.0273934,"For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.","[{'ForeName': 'Changjuan', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Chengjing', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of international medical research,['10.1177/0300060519893846']
993,32511687,Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials.,"Importance


Accumulation of disability in multiple sclerosis may occur as relapse-associated worsening (RAW) or steady progression independent of relapse activity (PIRA), with PIRA regarded as a feature of primary and secondary progressive multiple sclerosis.
Objective


To investigate the contributions of relapse-associated worsening vs relapse-independent progression to overall confirmed disability accumulation (CDA) and assess respective baseline prognostic factors and outcomes of 2 treatments.
Design, Setting, and Participants


Analyses occurred from July 2015 to February 2020 on pooled data from the intention-to-treat population of 2 identical, phase 3, multicenter, double-blind, double-dummy, parallel-group randomized clinical trials (OPERA I and II) conducted between August 2011 and April 2015. In the trials, patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria, were randomized from 307 trial sites in 56 countries; resulting data were analyzed in the pooled data set.
Interventions


Participants were randomized 1:1 to receive 600 mg of ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a 3 times a week at a dose of 44 μg throughout a 96-week treatment period.
Main Outcomes and Measures


Confirmed disability accumulation was defined by an increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test), confirmed after 3 or 6 months, and classified per temporal association with confirmed clinical relapses (PIRA or RAW).
Results


In the pooled OPERA I and II population (1656 of 2096 eligible participants), baseline demographics and disease characteristics were similar for patients randomized to interferon β-1a vs ocrelizumab (mean [SD] age, 37.2 [9.2] vs 37.1 [9.2] years; 552 [66.6%] vs 541 women [65.4%]). After 96 weeks, 12-week composite CDA had occurred in 223 (29.6% by Kaplan-Meier estimate) randomized to interferon β-1a and 167 (21.1%) randomized to ocrelizumab; 24-week composite CDA had occurred in 170 (22.7%) taking interferon β-1a and 129 (16.2%) taking ocrelizumab. The PIRA events were the main contributors to 12-week and 24-week composite CDA after 96 weeks in patients treated with interferon β-1a (174 of 223 [78.0%] and 137 of 170 [80.6%], respectively) and ocrelizumab (147 of 167 [88.0%] and 115 of 129 [89.1%], respectively); a minority had CDA explained by RAW events (69 of 390 [17.7%] and 52 of 299 [17.4%], respectively). Very few patients with composite CDA experienced both RAW and PIRA events (17 of 390 [4.4%] for 12-week and 15 of 299 [5.0%] for 24-week composite CDA). Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
Conclusions and Relevance


Most disability accumulation in RMS is not associated with overt relapses. This indicates an underlying progression in this typical RMS population and challenges the current clinical distinction of relapsing and progressive forms of multiple sclerosis. Ocrelizumab was superior to interferon β-1a in preventing both RAW and PIRA.
Trial Registration


ClinicalTrials.gov Identifiers: OPERA I (NCT01247324) and OPERA II (NCT01412333).",2020,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
","['patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria']","['ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a', 'Ocrelizumab (vs interferon β-1a', 'interferon β-1a vs ocrelizumab', 'Ocrelizumab']","['CDA explained by RAW events', 'reduced risk of composite CDA', 'baseline demographics and disease characteristics', 'RAW and PIRA events', 'confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events', 'disability accumulation', 'increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test', 'clinical relapses (PIRA or RAW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4517480', 'cui_str': '0.78'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",2096.0,0.167426,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Bernasconi', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Model', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shibeshih', 'Initials': 'S', 'LastName': 'Belachew', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Weill Institute for Neurosciences, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1568']
994,32510976,Single-Session Bronchial Thermoplasty Guided by  129 Xe Magnetic Resonance Imaging. A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Adverse events have limited the use of bronchial thermoplasty (BT) in severe asthma. Objectives:  We sought to evaluate the effectiveness and safety of using  129 Xe magnetic resonance imaging ( 129 Xe MRI) to prioritize the most involved airways for guided BT. Methods:  Thirty subjects with severe asthma were imaged with volumetric computed tomography and  129 Xe MRI to quantitate segmental ventilation defects. Subjects were randomized to treatment of the six most involved airways in the first session (guided group) or a standard three-session BT (unguided). The primary outcome was the change in Asthma Quality of Life Questionnaire score from baseline to 12 weeks after the first BT for the guided group compared with after three treatments for the unguided group. Measurements and Main Results:  There was no significant difference in quality of life after one guided compared with three unguided BTs (change in Asthma Quality of Life Questionnaire guided = 0.91 [95% confidence interval, 0.28-1.53]; unguided = 1.49 [95% confidence interval, 0.84-2.14];  P  = 0.201). After one BT, the guided group had a greater reduction in the percentage of poorly and nonventilated lung from baseline when compared with unguided (-17.2%;  P  = 0.009). Thirty-three percent experienced asthma exacerbations after one guided BT compared with 73% after three unguided BTs ( P  = 0.028). Conclusions:  Results of this pilot study suggest that similar short-term improvements can be achieved with one BT treatment guided by  129 Xe MRI when compared with standard three-treatment-session BT with fewer periprocedure adverse events.",2020,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).",['Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects'],"['standard three-session BT (unguided', '129 Xe Magnetic Resonance Imaging', 'Single-Session Bronchial Thermoplasty Guided by']","['quality of life', 'percent of poorly/non-ventilated lung', 'change in Asthma Quality of Life Questionnaire (AQLQ) score', 'asthma exacerbations', 'AQLQ and asthma control tests (ACT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}]",30.0,0.171046,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).","[{'ForeName': 'Chase S', 'Initials': 'CS', 'LastName': 'Hall', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Quirk', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kozlowski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Thomen', 'Affiliation': 'University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Woods', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mugler', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Gallagher', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Iulian C', 'Initials': 'IC', 'LastName': 'Ruset', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'F William', 'Initials': 'FW', 'LastName': 'Hersman', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-1021OC']
995,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
996,32529343,Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.,"PURPOSE


The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics.
METHODS


113 patients with stage I-IIIB breast cancer treated with chemotherapy were included in this randomized controlled trial. Patients were randomly allocated to receive either usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit. Patients completed questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication. From the 2nd visit onwards, patients in the intervention arm and their HCPs received a copy of the QoL overview and results were shown in patients' medical files. Audio-recordings and patients' self-reports were used to investigate effects on communication, patient management and patient-wellbeing. A composite score for communication was calculated by summing the number of QoL-topics discussed during each consultation.
RESULTS


Use of the QoL-monitor resulted in a higher communication score (0.7 topics increase per visit, p = 0.04), especially regarding the disease-specific and psychosocial issues (p < 0.01). There were no differences in patient management, QoL, illness perceptions or distress. Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05).
CONCLUSIONS


Use of a QoL-monitor during chemotherapy in patients with early breast cancer might result in a more frequent discussion of QoL-topics, associated with high levels of patients' satisfaction.",2020,"Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05).
","['Dutch patients with early breast cancer', 'patients with early breast cancer', '113 patients with stage I-IIIB breast cancer treated with']","['chemotherapy', 'usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit']","['disease-specific and psychosocial issues', 'satisfaction with communication', 'higher communication score', 'questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication', 'patient management, QoL, illness perceptions or distress']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",113.0,0.0328797,"Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05).
","[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Lugtenberg', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. r.t.lugtenberg@lumc.nl.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Fischer', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Jongh', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Saitama International Medical Center, Saitama, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Matsuda', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University Graduate School of Public Health, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Nippon Medical School, Saitama, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Weijl', 'Affiliation': 'Department of Medical Oncology, HMC Bronovo Hospital, The Hague, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University Graduate School of Public Health, Tokyo, Japan.'}, {'ForeName': 'S R S', 'Initials': 'SRS', 'LastName': 'Ramai', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Kaptein', 'Affiliation': 'Department of Medical Psychology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02549-8']
997,32533796,Attachment & Child Health (ATTACH) pilot trials: Effect of parental reflective function intervention for families affected by toxic stress.,"Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment. Parental reflective function-parents' capacity to understand their own and their child's mental states and thus regulate their own feelings and behavior toward their child-may buffer the negative effects of toxic stress on attachment. Our objective was to test the effectiveness of the Attachment and Child Health (ATTACH) intervention, focusing on improving reflective function and children's attachment security, for at-risk mothers and children <36 months of age. Three pilot studies were conducted with women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter. Randomized control trial (n = 20, n = 10 at enrollment) and quasi-experimental (n = 10 at enrollment) methods tested the effect of the ATTACH intervention on the primary outcome of reflective function scores, from transcribed Parent Development Interviews. Our secondary outcome was children's attachment patterns from Ainsworth's Strange Situation Procedure. Despite some attrition, mixed methods analysis of covariance and t tests revealed significant differences in maternal, child, and overall reflective function, with moderate effect sizes. While more children whose mothers received the ATTACH program were securely attached posttreatment, as compared with controls, significant differences were not observed, which may be due to missing observations (n = 5 cases). Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.",2020,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"['risk mothers and children <36 months of age', 'families affected by toxic stress', 'women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter']","['parental reflective function intervention', 'ATTACH intervention', 'Attachment and Child Health (ATTACH) intervention']","['Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0206072', 'cui_str': 'Family Violence'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0582758', 'cui_str': 'Insecure attachment'}]",,0.0662825,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Letourneau', 'Affiliation': 'Faculty of Nursing and Cumming School of Medicine, Departments of Pediatrics, Psychiatry, & Community Health Sciences, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Anis', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ntanda', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Novick', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}]",Infant mental health journal,['10.1002/imhj.21833']
998,31558730,Network-based Responses to the Psychomotor Vigilance Task during Lapses in Adolescents after Short and Extended Sleep.,"Neuroimaging studies of the Psychomotor Vigilance Task (PVT) have revealed brain regions involved in attention lapses in sleep-deprived and well-rested adults. Those studies have focused on individual brain regions, rather than integrated brain networks, and have overlooked adolescence, a period of ongoing brain development and endemic short sleep. This study used functional MRI (fMRI) and a contemporary analytic approach to assess time-resolved peri-stimulus response of key brain networks when adolescents complete the PVT, and test for differences across attentive versus inattentive periods and after short sleep versus well-rested states. Healthy 14-17-year-olds underwent a within-subjects randomized protocol including 5-night spans of extended versus short sleep. PVT was performed during fMRI the morning after each sleep condition. Event-related independent component analysis (eICA) identified coactivating functional networks and corresponding time courses. Analysis of salient time course characteristics tested the effects of sleep condition, lapses, and their interaction. Seven eICA networks were identified supporting attention, executive control, motor, visual, and default-mode functions. Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks. Well-circumscribed networks respond during the PVT in adolescents, with timing and intensity impacted by attentional lapses regardless of experimentally shortened or extended sleep.",2019,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","['Healthy 14-17-year-olds', 'Adolescents after Short and Extended Sleep']","['functional MRI (fMRI', 'PVT', '5-night spans of extended versus short sleep', 'Psychomotor Vigilance Task (PVT']","['sleep condition, lapses, and their interaction']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0320693,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'DiFrancesco', 'Affiliation': ""Pediatric Neuroimaging Research Consortium, Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. mark.difrancesco@cchmc.org.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Dyk', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Altaye', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'S P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash Institute for Cognitive and Clinical Neuroscience, School of Psychological Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}]",Scientific reports,['10.1038/s41598-019-50180-6']
999,32506421,Author response to: Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.573461,,"[{'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Steinemann', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}]",The British journal of surgery,['10.1002/bjs.11744']
1000,32506458,Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.651947,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parello', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ratto', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}]",The British journal of surgery,['10.1002/bjs.11745']
1001,32514756,"Effect of zinc supplementation on quality of life and sleep quality in young women with premenstrual syndrome: a randomized, double-blind, placebo-controlled trial.","INTRODUCTION


Premenstrual syndrome is a prevalent disorder affecting a large number of women in their reproductive ages. Nutritional importance of zinc has been known for a long time and studies have shown that zinc can positively affect psychological disorders.
PURPOSE


The aim of this study was to evaluate the effects of zinc supplementation on quality of life and sleep quality of young women diagnosed with premenstrual syndrome.
METHODS


This randomized, double-blind, placebo-controlled trial was carried out on 60 young university women that were allocated into two groups of intervention who took 30 mg/day of elemental zinc or placebo for three months. Pre- and post-intervention, participants completed the questionnaires of quality of life and Pittsburgh sleep quality.
RESULTS


After supplementation, quality of life score in the intervention group was increased (+ 9.185 ± 7.29, P < 0.001), however, in comparison with the control group, results were not significant; Physical aspects of quality of life score were significantly enhanced (+ 5.55 ± 3.71 vs. + 0.13 ± 2.87, P < 0.001). Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
CONCLUSION


Zinc supplementation for 12 weeks had beneficial effects on physical aspects of quality of life in young women with premenstrual syndrome.",2020,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","['60 young university women', 'young women with premenstrual syndrome', 'young women diagnosed with premenstrual syndrome']","['Zinc supplementation', 'elemental zinc or placebo', 'zinc supplementation', 'Pre- and post-intervention', 'placebo']","['quality of life', 'questionnaires of quality of life and Pittsburgh sleep quality', 'quality of life score', 'quality of life and sleep quality', 'Physical aspects of quality of life score', 'Sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.426181,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Farhang', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05628-w']
1002,32515543,Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.,"Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM), and new-generation basal insulins may improve patient outcomes. This post hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomized, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1 and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomized to Gla-300 and Gla-100, respectively, glycated haemoglobin reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than with Gla-100 (9.3%). From baseline to month 6, the risk of a first SH event was lower with Gla-300: hazard ratio 0.65 [95% confidence interval (CI) 0.44-0.98; stratified log-rank test P = 0.038]. SH event rates were numerically lower with Gla-300 versus Gla-100 from baseline to month 6 [relative risk (RR) 0.80 (95% CI 0.49-1.29); P = 0.356] and baseline to week 8 [RR 0.73 (95% CI 0.37-1.44); P = 0.369]. Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period.",2020,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,['Participants with Type 1 Diabetes'],"['Glargine 100', 'SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL', 'Insulin Glargine']","['incidence and time to first occurrence of SH', 'Severe hypoglycaemia (SH', '≥1 SH event with Gla-300', 'risk of a first SH event', 'SH event rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0663423,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sussebach', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14109']
1003,32516820,Improving Pediatric Hearing Testing for Children with Developmental Delays: The Effects of Video Modeling on Child Compliance and Caregiver Stress.,"BACKGROUND


For children with developmental delays (DDs) of any kind (e.g., global DDs, autism spectrum disorder, and Down syndrome), it is essential to understand if a hearing loss may be contributing to these delays. However, toddlers with DDs may have difficulty understanding directions, may be uncomfortable with a new situation, or may simply not want to complete the hearing testing tasks. Regardless of the reasons, noncompliant behaviors have a negative impact on hearing testing, which requires reliable behavioral responses from the child.
PURPOSE


The purpose of this study was to test a video intervention to improve hearing testing compliance in toddlers with developmental disabilities.
RESEARCH DESIGN


Double-blind randomized clinical trial.
STUDY SAMPLE


Twenty-four children with DDs between 24 and 36 months of age.
INTERVENTION


Video model of the hearing testing procedures.
DATA COLLECTION AND ANALYSIS


The primary child outcome measure was the number of hearing tests completed by the audiologist. Caregiver outcome included a parent survey of perceived stress level before and after the evaluation.
RESULTS


There was no significant difference between treatment and control groups regarding the number of hearing tests that were completed. Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group.
CONCLUSIONS


Pre-exposure to the hearing testing procedures did not significantly improve patient compliance but may reduce caregiver stress. Given the high rates of noncompliance in toddlers with DDs, audiologists may benefit from multiple strategies to help improve testing compliance.",2020,"Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group.
","['toddlers with developmental disabilities', 'Children with Developmental Delays', 'children with developmental delays (DDs', 'Twenty-four children with DDs between 24 and 36 months of age']","['video intervention', 'Video model of the hearing testing procedures', 'Video Modeling']","['patient compliance', 'Child Compliance and Caregiver Stress', 'number of hearing tests', 'stress', 'number of hearing tests completed by the audiologist', 'hearing testing compliance']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0018786', 'cui_str': 'Hearing examination'}]",24.0,0.0472382,"Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group.
","[{'ForeName': 'Megan Y', 'Initials': 'MY', 'LastName': 'Roberts', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rosenwasser', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Phelan', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Hampton', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18070']
1004,32517674,Reducing stigma and increasing workplace productivity due to mental health difficulties in a large government organization in the UK: a protocol for a randomised control treatment trial (RCT) of a low intensity psychological intervention and stigma reduction programme for common mental disorder (Prevail).,"BACKGROUND


Common mental disorders are the leading cause of workplace absences. While the reasons for this are multifarious, there is little doubt that stigma related to common mental disorder plays a large role in sickness absence and in poor help-seeking. Frequently both managers and staff are unsure of how to approach and intervene with mental health related problems. We have therefore devised a mental health intervention programme (Prevail) that aims to reduce stigma and to educate staff about evidence-based low intensity psychological interventions. These can be used by the individual, as well as in collaboration with managers via co-production of problem-focussed solutions, with the aim of improving mental health, reducing sickness absence, and increasing workplace productivity.
METHODS


This two-armed cluster randomised control trial (RCT) will evaluate the effectiveness of Prevail. Eighty managers at a large UK government institution (the DVLA) and their teams (approximately 960 employees) will be randomised into the active intervention group or control (employment as usual) arms of the study. All participants will be invited to complete a series of questionnaires related to mental health stigma, their current and past mental health, and their recent workplace productivity (absenteeism and presenteeism). All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder. The managers in the active arm will also receive the Prevail Managers programme which covers communication skills, problem formulation, and problem-solving skills. The questionnaire battery will then be given to both groups again 4 weeks post training, and 12 months post-training. Official records of absenteeism from Human Resources will also be gathered from both active and control groups at 12 months post-training.
DISCUSSION


The treatment trial aims to evaluate if Prevail reduces mental health related stigma (of a number of forms), increases help-seeking behaviours, and increases workplace productivity (via decreased absenteeism and presenteeism).
TRIAL REGISTRATION


ISRCTN12040087. Retrospectively registered 04/05/2020.",2020,"All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder.","['common mental disorder (Prevail', 'All participants will be invited to complete a series of questionnaires related to mental health stigma, their current and past mental health, and their recent workplace productivity (absenteeism and presenteeism', 'Eighty managers at a large UK government institution (the DVLA) and their teams (approximately 960 employees']","['active intervention group or control (employment as usual', 'low intensity psychological intervention and stigma reduction programme', 'psychoeducation about evidence-based low intensity psychological interventions']",['workplace productivity'],"[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.21631,"All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder.","[{'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, College of Human and Health Sciences, Swansea University, Swansea, Wales, SA2 8PP, UK. Nicola.s.gray@swansea.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Davies', 'Affiliation': 'Driver and Vehicle Licensing Agency (DVLA), Swansea, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Snowden', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, UK.'}]",BMC public health,['10.1186/s12889-020-09054-0']
1005,32520984,Effect of various exercises on frailty among older adults with subjective cognitive concerns: a randomised controlled trial.,"BACKGROUND


Physical exercise has been linked to reduced frailty, but there is insufficient evidence of beneficial effects in community-dwelling older adults with subjective cognitive concerns.
OBJECTIVE


This study aimed to clarify the effects of physical exercise in this population.
DESIGN


Single-blind randomised controlled trial.
SETTING


Community sports centres.
PARTICIPANTS


Residents aged 65-85 years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomised.
METHODS


This trial investigated the effects of aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs on reducing frailty. All participants were randomised into one of the three intervention groups or the control group. Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. A 95-item frailty index (FI) was utilised to determine the effects of training. Participants were followed up at weeks 26 and 52.
RESULTS


At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean FI score of 0.3 ± 0.1. Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52. No significant differences in FI were found in RT and AT+RT groups at weeks 26 and 52.
CONCLUSIONS


A 26-week AT reduced frailty modestly, especially in the depression and anxiety component, in older adults with subjective cognitive concerns.",2020,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","['Community sports centres', 'older adults with subjective cognitive concerns', '415 community-dwelling older adults', 'Residents aged 65-85\xa0years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment', 'community-dwelling older adults with subjective cognitive concerns']","['various exercises', 'lectures about health promotion', 'aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs', 'physical exercise', 'group training program and self-paced home training']","['FI', 'total FI', 'depression and anxiety component of FI']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",415.0,0.0634744,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","[{'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu City, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Age and ageing,['10.1093/ageing/afaa086']
1006,32520644,Comparison of 10 vs. 20 min neuromuscular training for the prevention of lower extremity injuries in male youth football: A cluster randomised controlled trial.,"The aim of this study was to compare the effects of 20 min neuromuscular training with a programme of 10 min in youth football players. 342 (15.4 ± 1.7 years) male football players from 18 teams were included, and cluster-randomized by team into two intervention groups. Both groups performed an injury prevention programme twice a week over five months using the same exercises but a different duration. The first intervention group (INT10, n = 175) performed the programme for 10 min, the second intervention group (INT20, n = 167) for 20 min. Primary outcomes were lower extremity (LE) injuries. Secondary outcomes were injury type, severity, mechanism and compliance to the intervention. 13 teams with 185 players were included for final analysis. No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism. The results show that performing preventive exercises for 10 min is no less effective than 20 min in youth football players. Shorter training sessions can, therefore, be effectively used for injury prevention.
TRIAL REGISTRATION


DRKS00015282.",2020,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","['1.7\xa0years', 'male football players from 18 teams', 'youth football players', '13 teams with 185 players were included for final analysis', '342 (15.4\xa0±', 'male youth football']","['20\xa0min neuromuscular training', 'neuromuscular training']","['lower extremity (LE) injuries', 'incidence rate ratio of the lower extremities', 'injury type, severity, mechanism and compliance to the intervention', 'INT10']","[{'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C4517579', 'cui_str': '15.4'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0885356,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","[{'ForeName': 'Anna Lina', 'Initials': 'AL', 'LastName': 'Rahlf', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}]",Journal of sports sciences,['10.1080/02640414.2020.1776459']
1007,32527192,Randomized Comparison of Intensified and Standard P2Y 12 -Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial.,"BACKGROUND


Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear.
METHODS


This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation.
RESULTS


Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32];  P =0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32),  P =0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73),  P =0.70, respectively.
CONCLUSIONS


In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.",2020,"At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32];  P =0.64).","['biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI', '781 patients included in the final analysis']","['elective PCI prasugrel 60 mg (ILS', 'Intensified and Standard P2Y 12 -Receptor-Inhibition', 'aspirin', 'clopidogrel']","['efficacy or safety', 'bleeding rates']","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",781.0,0.200622,"At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32];  P =0.64).","[{'ForeName': 'Julinda', 'Initials': 'J', 'LastName': 'Mehilli', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Baquet', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Hochholzer', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäres Herzzentrum Freiburg, Bad Krozingen, Germany (W.H., F.-J.N.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tesche', 'Affiliation': 'Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany (C.T., E.H.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Budapest, Hungary (D.A.).'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany (Y.X., U.M.).'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Thienel', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gschwendtner', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Zadrozny', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jochheim', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany (Y.X., U.M.).'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hoffmann', 'Affiliation': 'Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany (C.T., E.H.).'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäres Herzzentrum Freiburg, Bad Krozingen, Germany (W.H., F.-J.N.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008649']
1008,32530760,Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts.,"PURPOSE


Three new therapies have been approved recently for the adjuvant treatment of stage III melanoma, substantially reducing the risk of tumor recurrences. This study evaluates 3 independent data sets to clarify the survival probabilities of patients with stage III melanoma.
PATIENTS AND METHODS


The Central Malignant Melanoma Registry (CMMR) evaluated 1,553 patients with a primary diagnosis of stage III melanoma from 2000 to 2012. Studies from the European Organisation for Research and Treatment of Cancer (EORTC), of 573 patients in the observation arm of the 18991 study and 445 patients in the placebo arm of the 18071 study, were evaluated as reference cohorts. The survival outcomes were compared with the published American Joint Committee on Cancer version 8 (AJCCv8) stage III survival data.
RESULTS


For the CMMR stage III cohort versus the AJCCv8 cohort, the melanoma-specific survival (MSS) rates at 5 years were 67% versus 77%, and at 10 years were 56% versus 69%, respectively. For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%. The MSS rates of the EORTC studies either overlapped with or were lower than, the CMMR data.
CONCLUSION


The MSS rates in the CMMR and EORTC cohorts over the entire stage III are less favorable than those published in AJCCv8. This is particularly true for substages IIIA and IIIB.",2020,"For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%.","['573 patients in the observation arm of the 18991 study and 445 patients in the placebo arm of the 18071 study, were evaluated as reference cohorts', 'Patients With Stage III Melanoma', 'patients with stage III melanoma', 'The Central Malignant Melanoma Registry (CMMR) evaluated 1,553 patients with a primary diagnosis of stage III melanoma from 2000 to 2012']",[],"['MSS rates', 'survival probabilities', 'melanoma-specific survival (MSS) rates', 'survival outcomes', 'Cancer version 8 (AJCCv8) stage III survival data']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]",1553.0,0.101388,"For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%.","[{'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Keim', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Amaral', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Eigentler', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gesierich', 'Affiliation': 'Department of Dermatology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Heinzerling', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Skin Cancer Center, Department of Dermatology, Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, & German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Department of Dermatology, Johannes Wesling Hospital Minden, Ruhr-University of Bochum, Minden, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Sunderkötter', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Halle, Halle, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tüting', 'Affiliation': 'Department of Dermatology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Utikal', 'Affiliation': 'Skin Cancer Unit, German Cancer Research Center (DKFZ), Heidelberg, Germany and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wollina', 'Affiliation': 'Department of Dermatology and Allergology, Municipal Hospital of Dresden, Dresden, Germany.'}, {'ForeName': 'Christos C', 'Initials': 'CC', 'LastName': 'Zouboulis', 'Affiliation': 'Departments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Department of Dermatology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute of Clinical Epidemiology and Applied Biostatistics, Eberhard-Karls-University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03034']
1009,32530769,International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct.,"PURPOSE


To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naïve advanced anal cancer to establish the optimal regimen.
PATIENTS AND METHODS


Patients who had not received systemic therapy for advanced anal cancer were randomly assigned 1:1 to intravenous cisplatin 60 mg/m 2  (day 1) plus FU 1,000 mg/m 2  (days 1-4) every 21 days or carboplatin (area under the curve, 5; day 1) plus paclitaxel 80 mg/m 2  (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. Primary end point was objective response rate (ORR). Primary and secondary end points were assessed in a hierarchic model to compare the regimens and pick the winner.
RESULTS


We conducted an international multicenter randomized phase II study in 60 centers between December 2013 and November 2017. Median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin plus FU and 45 to carboplatin plus paclitaxel. ORR was 57% (95% CI, 39.4% to 73.7%) for cisplatin plus FU versus 59% (95% CI, 42.1% to 74.4%) for carboplatin plus paclitaxel. More serious adverse events were noted in the cisplatin plus FU arm (62%) compared with the carboplatin plus paclitaxel arm (36%;  P  = .016). Median progression-free survival was 5.7 months (95% CI, 3.3 to 9.0 months) for cisplatin plus FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin plus paclitaxel. Median overall survival was 12.3 months for cisplatin plus FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin plus paclitaxel (hazard ratio, 2.00; 95% CI, 1.15 to 3.47;  P  = .014).
CONCLUSION


This is the first international randomized trial to our knowledge conducted in chemotherapy-naïve advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.",2020,Median overall survival was 12.3 months for cisplatin plus FU,"['60 centers between December 2013 and November 2017', 'Advanced Anal Cancer', 'International Rare Cancers Initiative', 'A total of 91 patients were randomly assigned: 46 to', 'chemotherapy-naïve advanced anal cancer', 'Patients who had not received systemic therapy for advanced anal cancer']","['paclitaxel', 'cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel', 'carboplatin', 'carboplatin plus paclitaxel', 'cisplatin plus FU', 'Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel', 'intravenous cisplatin 60 mg/m 2  (day 1) plus FU 1,000 mg/m 2', 'cisplatin plus FU and 45 to carboplatin plus paclitaxel']","['Median overall survival', 'Median progression-free survival', 'objective response rate (ORR', 'toxicity', 'ORR', 'hierarchic model to compare the regimens and pick the winner', 'serious adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",91.0,0.183791,Median overall survival was 12.3 months for cisplatin plus FU,"[{'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sclafani', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adams', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Marianne G', 'Initials': 'MG', 'LastName': 'Guren', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segelov', 'Affiliation': 'Monash Health and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Amitesh', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Matt T', 'Initials': 'MT', 'LastName': 'Seymour', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Welch', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Cancer Centre, Manchester, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Dwyer"", 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Shree', 'Initials': 'S', 'LastName': 'Bhide', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Hamburg University Medical Centre, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03266']
1010,32539079,Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial.,"Importance


Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS.
Objective


To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS.
Design, Setting, and Participants


This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined).
Interventions


Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment.
Main Outcomes and Measures


The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood.
Results


Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site skin discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo.
Conclusions and Relevance


Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity.
Trial Registration


ClinicalTrials.gov Identifier: NCT01470521.",2020,"The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01).","['Sixty-six patients (93.0%) completed the trial', ""September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center"", 'Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic', 'Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined', 'Relapsing Multiple Sclerosis', 'Results\n\n\nPatients (mean [SD] age, 45 [9.5] years; 50 women [71']","['25 Necator americanus larvae transcutaneously or placebo', 'Placebo', 'Hookworm Treatment', 'placebo']","['low level of disease activity', 'Hookworm infection increased T regulatory cells', 'percentage of CD4+CD25highCD127negT cells', 'cumulative number of new/enlarging T2/new enhancing T1 lesions', 'application-site skin discomfort', 'magnetic resonance imaging (MRI) activity and T regulatory cells', 'adverse events', 'safe and well tolerated', 'median cumulative numbers of new/enlarging/enhancing lesions', 'adverse effects', 'percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002826', 'cui_str': 'Necator americanus'}, {'cui': 'C0023047', 'cui_str': 'Larvae'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019911', 'cui_str': 'Disease due to superfamily Ancylostomatoidea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0229986', 'cui_str': 'Application site'}, {'cui': 'C0863084', 'cui_str': 'Skin discomfort'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",73.0,0.688359,"The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01).","[{'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Tanasescu', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Tench', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Cris S', 'Initials': 'CS', 'LastName': 'Constantinescu', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Telford', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Nanci', 'Initials': 'N', 'LastName': 'Frakich', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Onion', 'Affiliation': 'Flow Cytometry Facilities, School of Life Sciences, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Dorothee P', 'Initials': 'DP', 'LastName': 'Auer', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gran', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Evangelou', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Falah', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ranshaw', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Cantacessi', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, England.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Jenkins', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, England.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Pritchard', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1118']
1011,32536195,Canakinumab After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation: A Pilot Randomized Trial.,,2020,,['Patients with Persistent Atrial Fibrillation'],['Canakinumab after Electrical Cardioversion'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]",[],,0.0404341,,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Krisai', 'Affiliation': 'Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Renate B', 'Initials': 'RB', 'LastName': 'Schnabel', 'Affiliation': 'Department of General and Interventional Cardiology, University Heart and Vascular Center Hamburg, Germany (R.B.S.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sticherling', 'Affiliation': 'Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kühne', 'Affiliation': 'Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'von Felten', 'Affiliation': 'German Center for Cardiovascular Research, Partner Site Hamburg/Kiel/Luebeck (R.B.S.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ammann', 'Affiliation': 'Department of Cardiology, Kantonsspital St. Gallen, Switzerland (P.A.).'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pruvot', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (E.P.).'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Albert', 'Affiliation': 'Department of Cardiology, Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA (C.M.A.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada (D.C.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008197']
1012,31537880,Addition of Epigallocatechin Gallate 400 mg to Sofosbuvir 400 mg + Daclatisvir 60 mg With or Without Ribavirin in Treatment of Patients with Chronic Hepatitis C Improves the Safety Profile: A Pilot Study.,"Emergence of new molecules acting directly on the hepatitic C virus (HCV) has improved treatment outcomes. However, there is a risk of selecting viral escape mutants, so a new combination is needed using different inhibitors that target different steps of the HCV infectious cycle. Novel single tablet formulations were developed: Dactavira, composed of sofosbuvir (SOF) 400 mg/daclatisvir (DCV) 60 mg/epigallocatechin gallate (EGCG) 400 mg without ribavirin (RBV); and Dactavira plus, which includes RBV 800 mg. A randomized, open-label study was carried out on treatment-naïve non-cirrhotic (Group A, n = 50) and treatment-naïve cirrhotic (Group B, n = 22) patients with genotype 4 HCV infection. Group A was randomly assigned to receive a single daily fixed-dose (Dactavira, n = 25) or the standard of care [SOF 400 mg/DCV 60 mg] (n = 25) daily for 12 weeks. Group B was randomly assigned to receive a single daily fixed-dose (Dactavira plus, n = 11) or the standard of care + RBV 800 mg (n = 11) daily for 12 weeks. Patients receiving Dactavira or Dactavira plus had a significantly more rapid rate of viral load decline as compared to patients receiving the standard of care therapy. Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care. Also, they did not affect normal hemoglobin levels (p < 0.001) versus the standard of care. The incorporated EGCG interferes with the viral entry mechanisms, as reported by several investigators, and in turn enhances efficacy and prevents relapse as compared to the standard of care. Also, its antihemeolytic and antifibrotic activities may improve the safety and tolerability of the therapy.",2019,Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care.,"['Patients with Chronic Hepatitis C', 'treatment-naïve non-cirrhotic (Group A, n\u2009=\u200950) and treatment-naïve cirrhotic (Group B, n\u2009=\u200922) patients with genotype 4 HCV infection']","['single daily fixed-dose (Dactavira, n\u2009=\u200925) or the standard of care [SOF 400\u2009mg/DCV', 'single daily fixed-dose (Dactavira plus, n\u2009=\u200911) or the standard of care\u2009+\u2009RBV 800\u2009mg', 'Dactavira or Dactavira plus', '400\u2009mg without ribavirin (RBV); and Dactavira plus', 'epigallocatechin gallate (EGCG', 'Epigallocatechin Gallate 400\u2009mg to Sofosbuvir 400\u2009mg\u2009+\u2009Daclatisvir 60\u2009mg With or Without Ribavirin']","['Safety Profile', 'normal hemoglobin levels', 'Sustained virological response', 'safety and tolerability', 'rapid rate of viral load decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0668209,Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care.,"[{'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Shiha', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Soliman', 'Affiliation': 'Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elbasiony', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Noureldien H E', 'Initials': 'NHE', 'LastName': 'Darwish', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Shaker A', 'Initials': 'SA', 'LastName': 'Mousa', 'Affiliation': 'The Pharmaceutical Research Institute, Albany College of Pharmacy and Health Sciences, Rensselaer, NY, USA. shaker.mousa@acphs.edu.'}]",Scientific reports,['10.1038/s41598-019-49973-6']
1013,32203176,Neurodevelopmental outcomes at 2 years in term and late preterm newborns enrolled in a trial of hydrocortisone for cardiovascular insufficiency.,,2020,,[],['hydrocortisone'],"['cardiovascular insufficiency', 'Neurodevelopmental outcomes']",[],"[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C1392046', 'cui_str': 'Cardiovascular insufficiency'}]",,0.083248,,"[{'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'MSC10 5590, 1 University of New Mexico, Albuquerque, NM, 87131, USA. Kwatterberg@salud.unm.edu.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0664-7']
1014,32500130,"Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE


Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP.
METHODS


We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data.
RESULTS


Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses.
CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.",2020,"CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","['patients with chronic pain are lacking', '248 participants (mean age = 46.4 years, 80% nonwhite', 'adults with cLBP', 'recruited predominantly low-income and racially diverse adults with cLBP', 'Chronic Low Back Pain', 'Participants (N\u2009=\u2009320']","['Physical Therapy, and Education Interventions', 'Yoga and PT', 'yoga and physical therapy (PT']","['PSS-10 scores', '10-item Perceived Stress Scale (PSS-10', 'Perceived Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",320.0,0.203356,"CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, Boston, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fredman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa150']
1015,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND


Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients.
MATERIALS AND METHODS


This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery.
RESULTS


The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05).
CONCLUSIONS


The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073']
1016,32516821,Influence of Provider Interaction on Patient's Readiness Toward Audiological Services and Technology.,"BACKGROUND


Patients and providers recognize the importance of patient-centered care. Clinical interactions, however, suggest that audiologists maintain their traditional provider-centered approach.
PURPOSE


The primary purpose of this study was to assess the degree to which provider interaction influenced patient readiness toward audiological services using the neobehavioral concept of need recognition described in consumer decision-making.
RESEARCH DESIGN


We used a randomized, within-group experimental approach using survey responses to quantify predisposed expectations on ten dimensions toward service and technology provision 2 weeks before and 2 weeks after an audiological assessment. Responses were also categorized as a function of the respondent-perceived professional setting of the provider (medical, rehabilitation, and consumer electronics).
STUDY SAMPLE


Survey respondents included 618 adults {186 males (mean age = 63.1 years; standard deviation [SD] = 5.3) and 432 females [mean age = 58.4 years; SD = 6.2]} from across the United States.
DATA COLLECTION AND ANALYSIS


Data were analyzed using two approaches. First, we used a two-step cluster analysis procedure that revealed natural groupings (i.e., profiles) of respondent characteristics of the ten dimensions. Second, we compared within-group mean differences between pre- and postappointment responses using a univariate analysis of variance, with mean differences reported as a function of professional setting and preappointment responses serving as the control condition.
RESULTS


Results revealed that the predisposed expectation profiles among the ten dimensions differed among the professional settings, with rehabilitation having the highest mean response values and consumer electronics having the least mean response values. A descriptive analysis indicated that respondents in the rehabilitation and medical settings presented the greatest interest in amplification before the patient-provider interaction, but the least interest afterward. In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings.
CONCLUSIONS


Overall, most respondents' predisposed expectations were unmet during their interaction with an audiologist. These expectations differed across professional settings, with the greatest unmet expectations observed in the rehabilitative and medical settings. Patient readiness is influenced by the behavior of the provider which, at present, appears to be a barrier to patients' acceptance of treatment options.",2020,"In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings.
",['SAMPLE\n\n\nSurvey respondents included 618 adults {186 males (mean age\u2009=\u200963.1 years; standard deviation [SD]\u2009=\u20095.3) and 432 females [mean age\u2009=\u200958.4 years; SD\u2009=\u20096.2]} from across the United States'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],[],618.0,0.0199614,"In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings.
","[{'ForeName': 'Amyn M', 'Initials': 'AM', 'LastName': 'Amlani', 'Affiliation': 'Audigy Group, Vancouver, WA.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.19051']
1017,32524895,Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial.,"BACKGROUND


Skilled birth attendants must be competent to provide prompt resuscitation to save newborn lives at birth. Both knowledge and skills (competence) decline with time after training but the optimal duration for refresher training among frontline-skilled birth attendants in low-resource settings is unknown.
OBJECTIVES


We assessed the effect of an innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention among skilled birth attendants in Northern Uganda.
METHODS


A total of 26 health facilities with 86 birth attendants were equally randomised to intervention and control arms. The 2nd edition of the American Association of Pediatrics Helping-Babies-Breathe curriculum was used for training and assessment. Knowledge and skills were assessed pre- and post-training, and during follow-up at 6 months. A mixed effects linear regression model for repeated measures was used to assess the short and long-term effects of the intervention on neonatal resuscitation practices while accounting for clustering.
RESULTS


Eighty-two (95.3%) skilled birth attendants completed follow-up at 6 months. Approximately 80% of these had no prior Helping-Babies-Breathe training and 75% reported practicing neonatal resuscitation routinely. Standard Helping-Babies-Breathe training with video-debriefing improved knowledge and skills attainment post-training [adjusted mean difference: 5.34; 95% CI: 0.82-10.78] and retention [adjusted mean difference: 2.97; 95% CI: 1.52-4.41] over 6 months post-training compared to standard training after adjusting for confounding and clustering. Factors that reduced knowledge and skills retention among birth attendants were monthly resuscitation of one neonate or more and being in service for more than 5 years.
CONCLUSION


Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda. However, more research is needed to justify the proposed intervention in this context.",2020,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"['A total of 26 health facilities with 86 birth attendants', 'skilled birth attendants in Northern Uganda', 'health workers in Uganda']","['innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention', 'video-debriefing to standard Helping-Babies-Breathe training']",['knowledge and skills retention'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0374356,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Odongkara', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pejovic', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Vincentina', 'Initials': 'V', 'LastName': 'Achora', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mukunya', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ndeezi', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nankabirwa', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}]",Global health action,['10.1080/16549716.2020.1743496']
1018,32524948,Rapid Reduction of  Campylobacter  Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter  has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in  Campylobacter  species after azithromycin treatment, generating the hypothesis that a decrease in  Campylobacter  may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940']
1019,31885346,Effects of transcranial direct current stimulation of primary motor cortex on cortical sensory deficits and hand dexterity in a patient with stroke: A case study.,"Fine motor and manual dexterity deficits are the main causes of significant physical and psychosocial impairments in stroke survivors. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique used to modulate brain activity and improve clinical outcomes. This study was performed to investigate the efficacy of dual-hemispheric tDCS of the primary motor cortex (M1) in a patient with stroke exhibiting cortical sensation deficits. A double-blind, sham-controlled, single-case study was conducted. The patient underwent 30 sessions of sham tDCS followed by 30 real-stimulation sessions over both M1 cortices. Each session involved 20 minutes of 2-mA stimulation (current density, 0.08 mA/cm 2 ; total charge density, 0.096 C/cm 2 ). Functional measures were assessed using the Action Research Arm Test, grooved pegboard test, nine-hole peg test, and box and block test at several time points. Structural and diffusion tensor imaging data were acquired before (t 0 ) and after (t 1 ) stimulation. Slight improvements following sham tDCS were observed. However, following real stimulation, all results at all time points were clinically significant. Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills. tDCS intervention induced functional improvement and structural changes in this patient with stroke.",2020,Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills.,"['patient with stroke exhibiting cortical sensation deficits', 'stroke survivors', 'patient with stroke']","['dual-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'tDCS intervention']","['corticospinal tract and regional gray matter density', 'Action Research Arm Test, grooved pegboard test, nine-hole peg test, and box and block test at several time points', 'cortical sensory deficits and hand dexterity', 'functional improvement and structural changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.109766,Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills.,"[{'ForeName': 'Turki S', 'Initials': 'TS', 'LastName': 'Abualait', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",The Journal of international medical research,['10.1177/0300060519894137']
1020,31891274,Effects of clean intermittent self-catheterization on late bladder dysfunction after radical hysterectomy in cervical cancer.,"OBJECTIVE


To identify the benefits of clean intermittent self-catheterization in women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer.
METHODS


Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited. A nursing intervention program focusing on clean intermittent self-catheterization and a drinking plan was implemented. We recorded urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments for patients with cervical cancer .
RESULTS


All patients were able to satisfactorily manage clean intermittent self-catheterization following video-based operational training. Bladder function was significantly increased after 3-month intervention compared with before the intervention. Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention. The rate of a positive catheter specimen of urine test significantly decreased over time. There was significant improvement in quality of life in five dimensions between weeks 1 and 12 following the intervention.
CONCLUSIONS


Patients are able to learn the technique of clean intermittent self-catheterization without any difficulty. This technique is effective together with a drinking plan to decrease late bladder dysfunction caused by radical hysterectomy in cervical cancer.",2020,"Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention.","['patients with cervical cancer ', 'women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer', 'Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited', 'late bladder dysfunction after radical hysterectomy in cervical cancer']",['clean intermittent self-catheterization'],"['quality of life', 'late bladder dysfunction', 'urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments', 'Bladder function', 'rate of a positive catheter specimen of urine test', 'Urinary times', 'post-voiding residual urine volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0473154', 'cui_str': 'Clean intermittent self-catheterization'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}]",30.0,0.0136846,"Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chun-Lan', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wan-Ying', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Guan-Mian', 'Initials': 'GM', 'LastName': 'Liang', 'Affiliation': 'Department of Head and Neck Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Li-Yao', 'Initials': 'LY', 'LastName': 'Xia', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}]",The Journal of international medical research,['10.1177/0300060519885546']
1021,32533948,Corneal Topography Raw Data Classification Using a Convolutional Neural Network.,"PURPOSE


We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of 3 categories: normal, keratoconus (KC), and history of refractive surgery (RS).
DESIGN


Retrospective machine-learning experimental study.
METHODS


A total of 3,000 Orbscan examinations (1,000 of each class) of different patients of our institution were selected for model training and validation. One hundred examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from ""elevation against the anterior best fit sphere (BFS),"" ""elevation against the posterior BFS"" ""axial anterior curvature,"" and ""pachymetry"" maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity were calculated for the validation set.
RESULTS


Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%). Sensitivity and specificity were, respectively, 100% and 100% for KC, 100% and 99% (94.9%-100%) for normal examinations, and 98% (97.4%-100%) and 100% for RS examinations.
CONCLUSION


Using combined corneal topography raw data with a convolutional neural network is an effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians), Paris, France.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005']
1022,32539588,The Impact of Interactive Shared Book Reading on Children's Language Skills: A Randomized Controlled Trial.,"Purpose Research has indicated that interactive shared book reading can support a wide range of early language skills and that children who are read to regularly in the early years learn language faster, enter school with a larger vocabulary, and become more successful readers at school. Despite the large volume of research suggesting interactive shared reading is beneficial for language development, two fundamental issues remain outstanding: whether shared book reading interventions are equally effective (a) for children from all socioeconomic backgrounds and (b) for a range of language skills. Method To address these issues, we conducted a randomized controlled trial to investigate the effects of two 6-week interactive shared reading interventions on a range of language skills in children across the socioeconomic spectrum. One hundred and fifty children aged between 2;6 and 3;0 (years;months) were randomly assigned to one of three conditions: a pause reading, a dialogic reading, or an active shared reading control condition. Results The findings indicated that the interventions were effective at changing caregiver reading behaviors. However, the interventions did not boost children's language skills over and above the effect of an active reading control condition. There were also no effects of socioeconomic status. Conclusion This randomized controlled trial showed that caregivers from all socioeconomic backgrounds successfully adopted an interactive shared reading style. However, while the interventions were effective at increasing caregivers' use of interactive shared book reading behaviors, this did not have a significant impact on the children's language skills. The findings are discussed in terms of practical implications and future research. Supplemental Material https://doi.org/10.23641/asha.12420539.",2020,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","['children across the socioeconomic spectrum', ""Children's Language Skills"", 'One hundred and fifty children aged between 2;6 and 3;0 (years;months']","['interactive shared reading interventions', 'Supplemental Material https://doi.org/10.23641/asha.12420539', 'Interactive Shared Book Reading', 'pause reading, a dialogic reading, or an active shared reading control condition']","[""children's language skills""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008081', 'cui_str': 'Child Language'}]",150.0,0.0973005,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Noble', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Cameron-Faulkner', 'Affiliation': 'School of Arts, Languages and Cultures, The University of Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jessop', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Sawyer', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Taylor-Ims', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Rowland', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00288']
1023,32546834,A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.,"BACKGROUND


Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA).
METHODS


A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA.
RESULTS


Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
CONCLUSION


DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT03097653.",2020,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","['Two thousand one hundred and nineteen women were randomised and 1001 completed the study', 'six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB']",['web-based dynamic decision aid (DA'],"['percentage of women attending screening', 'participation rate, satisfaction, decisional conflict, and acceptability of DA', 'Decisional conflict', 'informed choice measured on knowledge, attitudes, and intentions']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",2119.0,0.168763,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roberto', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Candiani', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Satolli', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Giordano', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jaramillo', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Castagno', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mantellini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Falini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carnesciali', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valenza', 'Affiliation': 'UO Centro Gestionale Screening, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'U.O.S. Screening Mammografico, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Campari', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Caroli', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Roberto Cosimo', 'Initials': 'RC', 'LastName': 'Faggiano', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orione', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Belmessieri', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Marchiò', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Deandrea', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Luciano', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Lega Italiana per la Lotta contro i Tumori, Sezione Firenze, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mosconi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. paola.mosconi@marionegri.it.'}]",British journal of cancer,['10.1038/s41416-020-0935-2']
1024,32548849,Duration of adhesion of swallowed alginates to distal oesophageal mucosa: implications for topical therapy of oesophageal diseases.,"BACKGROUND


We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears.
AIM


To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa.
METHODS


We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline.
RESULTS


In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01).
CONCLUSIONS


Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.",2020,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","['oesophageal diseases', 'healthy volunteers', '20 healthy volunteers and 10 patients with heartburn', 'distal oesophageal mucosa', 'Healthy volunteers']","['sodium alginate or placebo', '10\xa0mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry ', 'saline mixed with sucralose', 'swallowed alginate solution', 'placebo']",['oesophageal mucosa'],"[{'cui': 'C0014852', 'cui_str': 'Disorder of esophagus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]","[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]",20.0,0.0734851,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sonmez', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sifrim', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Woodland', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15884']
1025,32519878,"Response to Letter Regarding Article, ""Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial"".",,2020,,['Patients With Intermittent Claudication'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]",[],[],,0.220695,,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Djerf', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Millinger', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Falkenberg', 'Affiliation': 'Department of Radiology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sweden (M.F.).'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Jivegård', 'Affiliation': 'HTA Centrum (Health Technology Assessment Center) Västra Götaland (L.J.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Department of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden (M.S.).'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Nordanstig', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009385']
1026,32519889,Exercise Capacity and Ventricular Remodeling After Transcatheter Ventricular Septal Defect Closure in Asymptomatic or Minimally Symptomatic Adolescents and Adults.,"BACKGROUND


Transcatheter ventricular septal defect (VSD) closure is a safe and efficacious alternative to surgery. However, its benefits in asymptomatic or minimally symptomatic patients remain unknown.
METHODS


Sixty patients with VSD aged 12 to 60 years underwent cardiopulmonary exercise test and echocardiography 1 day before transcatheter VSD closure and 6 months after intervention (closure group). Thirty patients who did not receive the intervention underwent the same evaluations over 6 months (observation group).
RESULTS


No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat). Left ventricular end-diastolic dimension and mitral peak early filling velocity-to-early diastolic annular velocity ratio decreased (absolute decrease: 0.3±0.6 cm and 0.7±1.9, respectively). Despite unchanged overall peak O 2  consumption, 33% of closure group patients exhibited clinically significant improvements in peak O 2  consumption (>10% increase relative to baseline). This was not related to the pulmonary flow-to-systemic flow ratio or baseline exercise capacity. By contrast, all exercise function parameters deteriorated significantly in the observation group. Subgroup analysis revealed that patients with a baseline left ventricular end-diastolic dimension  Z  score of >2 exhibited a significantly greater improvement in peak O 2  consumption, peak O 2  pulse, and oxygen uptake efficiency slope than did the observation group.
CONCLUSIONS


Compared with conservative management, transcatheter VSD closure prevents deterioration in exercise capacity and promotes left ventricular reverse remodeling in asymptomatic or minimally symptomatic patients. These benefits are most prominent in patients whose left ventricular end-diastolic dimension  Z  score before intervention is >2, irrespective of baseline peak O 2  consumption and pulmonary flow/systemic flow ratio. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03127748.",2020,"No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat).","['Thirty patients who did not receive the intervention underwent the same evaluations over 6 months (observation group', 'Asymptomatic or Minimally Symptomatic Adolescents and Adults', 'asymptomatic or minimally symptomatic patients', 'Sixty patients with VSD aged 12 to 60 years underwent']","['Transcatheter ventricular septal defect (VSD', 'transcatheter VSD closure', 'Transcatheter Ventricular Septal Defect Closure', 'cardiopulmonary exercise test and echocardiography 1 day before transcatheter VSD closure and 6 months after intervention (closure group']","['peak O 2  consumption', 'Exercise Capacity and Ventricular Remodeling', 'peak oxygen (O 2 ) pulse', 'exercise function', 'Left ventricular end-diastolic dimension and mitral peak early filling velocity-to-early diastolic annular velocity ratio', 'pulmonary flow-to-systemic flow ratio or baseline exercise capacity', 'peak O 2  consumption, peak O 2  pulse, and oxygen uptake efficiency slope']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0190023', 'cui_str': 'Closure of ventricular septal defect'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",60.0,0.0378883,"No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat).","[{'ForeName': 'Chun-An', 'Initials': 'CA', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Jou-Kou', 'Initials': 'JK', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Ming-Tai', 'Initials': 'MT', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Hsin-Hui', 'Initials': 'HH', 'LastName': 'Chiu', 'Affiliation': 'Department of Pediatrics, Taipei Tzu Chi Hospital, New Taipei City, Taiwan (H.-H.C.).'}, {'ForeName': 'Jui-Yu', 'Initials': 'JY', 'LastName': 'Hsu', 'Affiliation': 'Dianthus MFM clinic, Taipei, Taiwan (J.-Y.H., Y.-M.C.).'}, {'ForeName': 'Shu-Man', 'Initials': 'SM', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, National Yang-Ming University, Taipei, Taiwan (S.-M.L.).'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Chang', 'Affiliation': 'Dianthus MFM clinic, Taipei, Taiwan (J.-Y.H., Y.-M.C.).'}, {'ForeName': 'Shuenn-Nan', 'Initials': 'SN', 'LastName': 'Chiu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Chun-Wei', 'Initials': 'CW', 'LastName': 'Lu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Mei-Hwan', 'Initials': 'MH', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Ming-Chun', 'Initials': 'MC', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, E-DA Hospital, Kaoshiung, Taiwan (M.-C.Y.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008813']
1027,32519891,"Letter by Ng and Choong Regarding Article, ""Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial"".",,2020,,['Patients With Intermittent Claudication'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]",[],[],,0.22088,,"[{'ForeName': 'Jun Jie', 'Initials': 'JJ', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore. Division of Vascular and Endovascular Surgery, National University Heart Centre Singapore. Singapore Vascular Surgical Collaborative.'}, {'ForeName': 'Andrew M T L', 'Initials': 'AMTL', 'LastName': 'Choong', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore. Division of Vascular and Endovascular Surgery, National University Heart Centre Singapore. Singapore Vascular Surgical Collaborative.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009322']
1028,31617430,Therapeutic effect of one-time root canal treatment for irreversible pulpitis.,"OBJECTIVE


To compare the therapeutic effects of one-time root canal treatment versus two-time treatment in patients with irreversible pulpitis.
METHODS


We classified 130 patients into a one-time treatment group (group A; n = 68) and a two-time treatment group (group B; n = 62) according to the number of patient visits. Clinical efficacy at 6 months and 1 year follow-ups as well as serum levels of interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein before and 1 week after endodontic treatment were observed. Additionally, the level of treatment satisfaction between the two groups was compared, and the degree of pain was evaluated using the visual analogue scale.
RESULT


One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B.
CONCLUSION


One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.",2020,"One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B.
CONCLUSION


One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.","['patients with irreversible pulpitis', 'irreversible pulpitis']",['time root canal treatment'],"['Clinical efficacy', 'level of treatment satisfaction', 'visual analogue scale', 'postoperative pain', 'degree of pain', 'serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels', 'visual analogue scale scores', 'serum levels of interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",130.0,0.0149998,"One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B.
CONCLUSION


One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chengxia', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}]",The Journal of international medical research,['10.1177/0300060519879287']
1029,32533791,The effect of dexmedetomidine on postoperative behaviour change in children: a randomised controlled trial.,"Children may develop changes in their behaviour following general anaesthesia. Some examples of negative behaviour include temper tantrums and nightmares, as well as sleep and eating disorders. The aim of this study was to determine whether dexmedetomidine reduces the incidence of negative behaviour change after anaesthesia for day case surgery in children aged two to seven years. Children were randomly allocated to one of three groups: a premedication group received 2 mg.kg -1  intranasal dexmedetomidine; an intra-operative group received 1 mg.kg -1  intravenous dexmedetomidine; and a control group. The primary outcome was the incidence of negative behaviour on postoperative day 3 using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strength and Difficulties Questionnaire (SDQ). Secondary outcomes included: the incidence of negative behaviour on postoperative days 14 and 28; anxiety at induction; emergence delirium; pain; length of recovery and hospital stay; and any adverse events. The data for 247 patients were analysed. Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99). The incidence of negative behaviour in the group who received dexmedetomidine intra-operatively was less at postoperative day 28 (15% compared with 36% in the dexmedetomidine premedication group and 41% in the control group, p<0.001). We conclude that dexmedetomidine does not reduce the incidence of negative behaviour on postoperative day 3 in two to seven-year olds having day case procedures.",2020,"Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99).","['children aged two to seven years', '247 patients were analysed', 'children']","['dexmedetomidine', 'premedication group received 2 mg.kg -1  intranasal dexmedetomidine']","['incidence of negative behaviour on postoperative days 14 and 28; anxiety at induction; emergence delirium; pain; length of recovery and hospital stay; and any adverse events', 'SDQ', 'Negative behaviour change on postoperative day 3', 'negative behaviour change', 'PHBQ-AS', 'incidence of negative behaviour on postoperative day 3 using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strength and Difficulties Questionnaire (SDQ', 'incidence of negative behaviour', 'postoperative behaviour change']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",247.0,0.128924,"Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99).","[{'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Lee-Archer', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'von Ungern-Sternberg', 'Affiliation': ""Department of Anaesthesia and Pain Management, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reade', 'Affiliation': 'Royal Brisbane Clinical Unit, Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Betts', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haenke', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Keys', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rance', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gibbons', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}]",Anaesthesia,['10.1111/anae.15117']
1030,32533172,The Effects of a Vocabulary Intervention on Teaching Multiple-Meaning Words to Students Who Are d/Deaf and Hard of Hearing.,"Building vocabulary knowledge, especially breadth and depth of word meanings, is a crucial step in assisting students to read and comprehend print independently. A large body of research has documented the low reading achievement levels of a number of Deaf and hard-of-hearing (DHH) students. The goal of the present study was to examine the effects of a vocabulary intervention to teach 24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants). A total of 5 students with a profound hearing loss participated in the study. About 3 of 5 received the intervention, whereas two other students served as an additional control component and were administered the pretest and posttest only. The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention. In contrast, students who did not receive the intervention showed no significant improvement on the posttest.",2020,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"['Students', '24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants', '5 students with a profound hearing loss participated in the study']","['vocabulary intervention', 'Vocabulary Intervention']",['recognition and comprehension scores'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5.0,0.0168948,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"[{'ForeName': 'Faisl M', 'Initials': 'FM', 'LastName': 'Alqraini', 'Affiliation': 'Prince Sattam bin Abdulaziz University.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Paul', 'Affiliation': 'The Ohio State University.'}]",Journal of deaf studies and deaf education,['10.1093/deafed/enaa015']
1031,32539157,"A Randomized Clinical Trial Exploring Gambling Attitudes, Barriers to Treatment, and Efficacy of a Brief Motivational Intervention Among Ex-Offenders with Disordered Gambling.","Correctional populations are disproportionately burdened by disordered gambling; yet, problem awareness is minimal among both offenders and professionals within the criminal justice system. The aims of the current study were twofold: (i) to examine gambling attitudes and problem awareness among ex-offenders, and (ii) to determine the efficacy of a brief online gambling intervention for ex-offenders. Participants (N = 126) were ex-offenders on probation and parole. Gambling attitudes, attitudes toward treatment, and disorder gambling status were assessed. Disordered gamblers (n = 102) were randomly assigned to (i) a brief intervention plus referral to treatment or (ii) referral to treatment only, and these individuals were re-assessed at a 30-day follow-up. Lifetime disordered gambling was highly prevalent (86%) in the ex-offender sample, and providing information regarding disordered gambler status and referral to treatment was effective in decreasing gambling attitudes, as well as gambling severity and frequency. The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.",2020,The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.,"['Ex-Offenders with Disordered Gambling', 'ex-offenders', 'Disordered gamblers (n\xa0=\xa0102', 'Participants (N\xa0=\xa0126) were ex-offenders on probation and parole']","['brief intervention plus referral to treatment or (ii) referral to treatment only, and these individuals were re-assessed at a 30-day follow-up', 'online gambling intervention', 'Brief Motivational Intervention']","['gambling attitudes', 'Lifetime disordered gambling', 'Gambling attitudes, attitudes toward treatment, and disorder gambling status']","[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0425169', 'cui_str': 'On probation'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",126.0,0.0205525,The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.,"[{'ForeName': 'Laura April', 'Initials': 'LA', 'LastName': 'Rosen', 'Affiliation': 'Department of Psychology, Saint Louis University, 3700 Lindell Blvd., Morrissey Hall, St. Louis, MO.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Weinstock', 'Affiliation': 'Department of Psychology, Saint Louis University, 3700 Lindell Blvd., Morrissey Hall, St. Louis, MO.'}, {'ForeName': 'Samuel Cody', 'Initials': 'SC', 'LastName': 'Peter', 'Affiliation': 'Department of Psychology, The University of Memphis, 400 Innovation Dr., Memphis, TN, 38111.'}]",Journal of forensic sciences,['10.1111/1556-4029.14476']
1032,32539832,"Treatment with anagliptin, a DPP-4 inhibitor, decreases FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy.","BACKGROUND


Fatty acid-binding protein 4 (FABP4) acts as a novel adipokine, and elevated FABP4 concentration is associated with obesity, insulin resistance and atherosclerosis. Dipeptidyl peptidase-4 (DPP-4) inhibitors, a class of antidiabetic drugs, have distinct structures among the drugs, possibly leading to a drug class effect and each drug effect. Sitagliptin, a DPP-4 inhibitor, has been reported to decrease FABP4 concentration in drug-naïve and sulfonylurea-treated patients with type 2 diabetes mellitus. Anagliptin, another DPP-4 inhibitor, was shown to decrease low-density lipoprotein cholesterol (LDL-C) level to a greater extent than that by sitagliptin in the Randomized Evaluation of Anagliptin vs. Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) trial.
AIM AND METHODS


As a sub-analysis study using data obtained from the REASON trial, we investigated the effects of treatment with anagliptin (n = 148, male/female: 89/59) and treatment with sitagliptin (n = 159, male/female: 93/66) for 52 weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy.
RESULTS


The DPP-4 inhibitor had been administered in 82% of the patients in the anagliptin group and 81% of the patients in sitagliptin group prior to randomization. Serum FABP4 level was significantly decreased by 7.9% by treatment with anagliptin (P = 0.049) and was not significantly decreased by treatment with sitagliptin (P = 0.660). Change in FABP4 level was independently associated with basal FABP4 level and changes in waist circumference and creatinine after adjustment of age, sex and the treatment group.
CONCLUSION


Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy. Trial registration ClinicalTrials.gov number NCT02330406. Registered January 5, 2015, https://clinicaltrials.gov/ct2/show/NCT02330406.",2020,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"['patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy', 'patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy', 'n\u2009=\u2009148, male/female: 89/59) and treatment with sitagliptin (n\u2009=\u2009159, male/female: 93/66) for 52\xa0weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy', 'treated patients with type 2 diabetes mellitus']","['anagliptin, a DPP-4 inhibitor', 'Dipeptidyl peptidase-4 (DPP-4) inhibitors', 'Anagliptin vs. Sitagliptin', 'anagliptin', 'sulfonylurea']","['basal FABP4 level and changes in waist circumference and creatinine', 'serum FABP4 concentration', 'low-density lipoprotein cholesterol (LDL-C) level', 'FABP4 level', 'Serum FABP4 level', 'FABP4 concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3272640', 'cui_str': 'anagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.0896455,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan. furuhasi@sapmed.ac.jp.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yukimura', 'Initials': 'Y', 'LastName': 'Higashiura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Sakai', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, Tomigusuku, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01061-0']
1033,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1034,32557475,Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial.,"BACKGROUND


The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy.
METHODS


We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases.
RESULTS


657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %;  P  = 0.001).
CONCLUSION


Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.",2020,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","['patients who could be contacted by telephone and the control cases', 'Consecutive outpatients with previous inadequate bowel preparation were enrolled', '657 participants were recruited by 11 Spanish hospitals']","['Educational nurse-led telephone intervention shortly before colonoscopy', 'reinforced education by telephone', 'Intention-to-treat (ITT']","['bowel cleansing', 'rate of successful bowel preparation', 'effective bowel preparation according to the Boston Bowel Preparation Scale', 'bowel preparation', 'cleansing efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1446338', 'cui_str': 'Inadequate bowel preparation'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}]",657.0,0.27856,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","[{'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Alvarez-Gonzalez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Pantaleón Sánchez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Bernad Cabredo', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Rodríguez', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Frago Larramona', 'Affiliation': 'Department of Digestive Diseases, Hospital Santa Bárbara, Soria, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nogales', 'Affiliation': 'Department of Digestive Diseases, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Díez Redondo', 'Affiliation': 'Department of Digestive Diseases, Hospital del Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Puig Del Castillo', 'Affiliation': 'Department of Digestive Diseases, Altahia Xarxa Asistencial Universitaria de Manresa, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero Mascarell', 'Affiliation': 'Department of Digestive Diseases, Consorci Sanitari de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Caballero', 'Affiliation': 'Department of Digestive Diseases, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Romero Sánchez-Miguel', 'Affiliation': 'Department of Digestive Diseases, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Pérez Berbegal', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernández Negrín', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Bujedo Sadornill', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Pérez Oltra', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Casals Urquiza', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Amorós Martínez', 'Affiliation': 'Open University of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Seoane Urgorri', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Inés Ana', 'Initials': 'IA', 'LastName': 'Ibáñez Zafón', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}]",Endoscopy,['10.1055/a-1178-9844']
1035,32558989,"Effects of danicamtiv, a novel cardiac myosin activator, in heart failure with reduced ejection fraction: experimental data and clinical results from a phase 2a trial.","AIMS


Both left ventricular (LV) and left atrial (LA) dysfunction and remodelling contribute to adverse outcomes in heart failure with reduced ejection fraction (HFrEF). Danicamtiv is a novel, cardiac myosin activator that enhances cardiomyocyte contraction.
METHODS AND RESULTS


We studied the effects of danicamtiv on LV and LA function in non-clinical studies (ex vivo: skinned muscle fibres and myofibrils; in vivo: dogs with heart failure) and in a randomized, double-blind, single- and multiple-dose phase 2a trial in patients with stable HFrEF (placebo, n = 10; danicamtiv, n = 30; 50-100 mg twice daily for 7 days). Danicamtiv increased ATPase activity and calcium sensitivity in LV and LA myofibrils/muscle fibres. In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL, P < 0.05) and LA emptying fraction (+10.7%, P < 0.05). In patients with HFrEF (mean age 60 years, 25% women, ischaemic heart disease 48%, mean LV ejection fraction 32%), treatment-emergent adverse events, mostly mild, were reported in 17 patients (57%) receiving danicamtiv and 4 patients (40%) receiving placebo. Danicamtiv (at plasma concentrations ≥2000 ng/mL) increased stroke volume (up to +7.8 mL, P < 0.01), improved global longitudinal (up to -1.0%, P < 0.05) and circumferential strain (up to -3.3%, P < 0.01), decreased LA minimal volume index (up to -2.4 mL/m 2  , P < 0.01) and increased LA function index (up to 6.1, P < 0.01), when compared with placebo.
CONCLUSIONS


Danicamtiv was well tolerated and improved LV systolic function in patients with HFrEF. A marked improvement in LA volume and function was also observed in patients with HFrEF, consistent with pre-clinical findings of direct activation of LA contractility.",2020,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","['heart failure with reduced ejection fraction', 'heart failure with reduced ejection fraction (HFrEF', 'vivo: dogs with heart failure', 'patients with stable', 'patients with HFrEF']","['danicamtiv, a novel cardiac myosin activator', 'HFrEF (placebo', 'placebo']","['circumferential strain', 'LA function index', 'LA volume and function', 'stroke volume', 'tolerated and improved LV systolic function', 'LV and LA function', 'LA minimal volume index', 'LA emptying fraction', 'LV stroke volume', 'global longitudinal', 'ATPase activity and calcium sensitivity']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949656', 'cui_str': 'Cardiac Myosin'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.144767,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tamby', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Forgosh', 'Affiliation': 'HealthEast Heart Care, Saint Paul, MN, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Tennova Healthcare-Harton, Tullahoma, TN, USA.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henk P', 'Initials': 'HP', 'LastName': 'Swart', 'Affiliation': 'Antonius Ziekenhuis Sneek, Sneek, The Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organization, Berlin, Germany.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Hershberger', 'Affiliation': 'Divisions of Human Genetics and Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Imaging Core Laboratory, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Anto', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kaylyn', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Henze', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Teichman Drug Development Consulting, Oakland, CA, USA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Del Rio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1933']
1036,32553191,"Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.","BACKGROUND


Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery.
METHODS


This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560.
FINDINGS


Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00).
INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries.
FUNDING


Keio University and Ohyama Health Foundation.",2020,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","['Patients aged 20 years or older who underwent elective clean-contaminated wound surgery', 'Between June 10, 2018, and April 18, 2019', 'patients who undergo clean-contaminated surgeries', '587 patients were eligible and 294 received', 'clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals', 'surgical site infections after clean-contaminated surgery', '0·48', '883 patients were assessed for eligibility']","['surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery', 'olanexidine and 293 received aqueous povidone-iodine before surgery', 'chlorhexidine-alcohol and povidone-iodine', 'aqueous olanexidine and aqueous povidone-iodine', 'Olanexidine', 'olanexidine', 'Aqueous olanexidine versus aqueous povidone-iodine', 'povidone-iodine', 'surgical skin antisepsis', 'aqueous povidone-iodine']","['SSI rate', 'adverse skin reactions', '30-day SSI assessed in the intention-to-treat population', 'bactericidal activity', 'efficacy and safety', '30-day SSI', 'occurrence of overall SSI and superficial incisional SSI', 'risk ratio [RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0755906', 'cui_str': 'olanexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3662309', 'cui_str': 'Superficial incisional surgical site infection'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",883.0,0.17549,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Obara', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan. Electronic address: obara.z3@keio.jp.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okabayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30225-5']
1037,32551817,Machine Learning Classifier Models Can Identify Acute Respiratory Distress Syndrome Phenotypes Using Readily Available Clinical Data.,"Rationale:  Two distinct phenotypes of acute respiratory distress syndrome (ARDS) with differential clinical outcomes and responses to randomly assigned treatment have consistently been identified in randomized controlled trial cohorts using latent class analysis. Plasma biomarkers, key components in phenotype identification, currently lack point-of-care assays and represent a barrier to the clinical implementation of phenotypes. Objectives:  The objective of this study was to develop models to classify ARDS phenotypes using readily available clinical data only. Methods:  Three randomized controlled trial cohorts served as the training data set (ARMA [High vs. Low Vt], ALVEOLI [Assessment of Low Vt and Elevated End-Expiratory Pressure to Obviate Lung Injury], and FACTT [Fluids and Catheter Treatment Trial];  n  = 2,022), and a fourth served as the validation data set (SAILS [Statins for Acutely Injured Lungs from Sepsis];  n  = 745). A gradient-boosted machine algorithm was used to develop classifier models using 24 variables (demographics, vital signs, laboratory, and respiratory variables) at enrollment. In two secondary analyses, the ALVEOLI and FACTT cohorts each, individually, served as the validation data set, and the remaining combined cohorts formed the training data set for each analysis. Model performance was evaluated against the latent class analysis-derived phenotype. Measurements and Main Results:  For the primary analysis, the model accurately classified the phenotypes in the validation cohort (area under the receiver operating characteristic curve [AUC], 0.95; 95% confidence interval [CI], 0.94-0.96). Using a probability cutoff of 0.5 to assign class, inflammatory biomarkers (IL-6, IL-8, and sTNFR-1;  P  < 0.0001) and 90-day mortality (38% vs. 24%;  P  = 0.0002) were significantly higher in the hyperinflammatory phenotype as classified by the model. Model accuracy was similar when ALVEOLI (AUC, 0.94; 95% CI, 0.92-0.96) and FACTT (AUC, 0.94; 95% CI, 0.92-0.95) were used as the validation cohorts. Significant treatment interactions were observed with the clinical classifier model-assigned phenotypes in both ALVEOLI ( P  = 0.0113) and FACTT ( P  = 0.0072) cohorts. Conclusions:  ARDS phenotypes can be accurately identified using machine learning models based on readily available clinical data and may enable rapid phenotype identification at the bedside.",2020,"Model accuracy was similar when ALVEOLI (AUC 0.94, CI:0.92-0.96) and FACTT (AUC 0.94, CI:0.92-0.95) were the validation cohorts.",[],[],"['inflammatory biomarkers (Interleukin-6, Interleukin-8, Protein C, and sTNFR-1; p<0.0001) and 90-day mortality', 'Model accuracy']",[],[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0033621', 'cui_str': 'Protein C'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0627125,"Model accuracy was similar when ALVEOLI (AUC 0.94, CI:0.92-0.96) and FACTT (AUC 0.94, CI:0.92-0.95) were the validation cohorts.","[{'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Sinha', 'Affiliation': 'Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Department of Medicine, and.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Churpek', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, Madison, Wisconsin.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Department of Medicine, and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202002-0347OC']
1038,31802692,Effects of probiotics combined with early enteral nutrition on endothelin-1 and C-reactive protein levels and prognosis in patients with severe traumatic brain injury.,"OBJECTIVE


To investigate the effects of probiotics combined with early enteral nutrition on levels of endothelin-1 (ET-1), C-reactive protein (CRP), and inflammatory factors, and on the prognosis of patients with severe traumatic brain injury (TBI).
METHODS


We enrolled 76 adults with severe TBI. The patients were divided randomly into two equal groups administered enteral nutrition with and without probiotics, respectively. Demographic and clinical data including age, sex, Glasgow Coma Scale score, Sequential Organ Failure Score, Acute Physiology, Chronic Health Score, hospitalization, mortality, and infections were recorded.
RESULTS


Serum levels of inflammatory factors gradually decreased with increasing treatment time in both groups. However, ET-1 at 15 days, and interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α, and CRP at 7 and 15 days decreased significantly more in the combined treatment group. Hospitalization duration and pulmonary infection rates were also significantly reduced in the combined compared with the enteral nutrition alone group. GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group.
CONCLUSION


Probiotics combined with early enteral nutrition could reduce serum levels of ET-1, CRP, and IL-6, IL-10, and TNF-α, and could thus improve the recovery of patients with severe TBI.",2020,"GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group.
","['patients with severe traumatic brain injury', '76 adults with severe TBI', 'patients with severe traumatic brain injury (TBI']","['probiotics combined with early enteral nutrition', 'enteral nutrition with and without probiotics']","['Demographic and clinical data including age, sex, Glasgow Coma Scale score, Sequential Organ Failure Score, Acute Physiology, Chronic Health Score, hospitalization, mortality, and infections', 'Hospitalization duration and pulmonary infection rates', 'Serum levels of inflammatory factors', 'levels of endothelin-1 (ET-1), C-reactive protein (CRP), and inflammatory factors', 'interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α, and CRP', 'serum levels of ET-1, CRP, and IL-6, IL-10, and TNF-α', 'GCS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",76.0,0.0303593,"GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group.
","[{'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Wan', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Guanhong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Joint Surgery, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Sinopec Group Shengli Petroleum Administration Shengcai Hospital, Dongying, China.'}, {'ForeName': 'Xinhao', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Scientific Education Section, Shengli Oilfield Central Hospital, Dongying, China.'}]",The Journal of international medical research,['10.1177/0300060519888112']
1039,32539729,"Newborn Behavioral Observation, maternal stress, depressive symptoms and the mother-infant relationship: results from the Northern Babies Longitudinal Study (NorBaby).","BACKGROUND


Families can experience the postpartum period as overwhelming and many report a special need for support. The Newborn Behavioral Observation (NBO) aims to promote a positive parent-infant relationship by sensitising parents to the infant's signals. This article evaluates the NBO as a universal preventive intervention within the regular well-baby clinic service on measures of maternal depressive symptoms, parental stress, the mother-infant relationship and satisfaction/benefit of the postpartum follow-up.
METHODS


This investigation is part of a larger longitudinal study comprising 220 women and 130 of their partners recruited between 2015 and 2017. The study had a non-randomised cluster-controlled design with 6 measurement points. This article is based on a sample of 196 women using data from T1 (gestational weeks 13-39), T4 (5-15 weeks postpartum) and T5 (3-9 months postpartum). Participants were allocated to a group receiving the NBO (n = 82) and a care as usual comparison group (n = 114). We measured maternal depressive symptoms and parental stress using the Edinburgh Postnatal Depression Scale (EPDS) and the Parenting Stress Index (PSI). The mother-infant relationship was assessed with the Parental Reflective Functioning Questionnaire (PRFQ), the Maternal Postnatal Attachment Scale (MPAS) and the Maternal Confidence Questionnaire (MCQ). Participants also answered questions about satisfaction/benefit of the postpartum follow-up.
RESULTS


A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness. Multivariate analyses of covariance (MANCOVA) and repeated measures ANCOVA found no significant differences between the groups for the mother-infant relationship domain and few differences in depressive symptoms and parental stress. The repeated measures ANCOVA found that participants in the NBO-group scored slightly higher on parental stress, although the difference was small.
CONCLUSIONS


The results indicate that the NBO-group learned more than the comparison group about reading their child's signals in important everyday situations. However, the benefits of the NBO were limited for depressive symptoms, parental stress and self-reported mother-infant relationship. The study sample was generally well-functioning, and the results indicate that the benefits of the NBO may be limited within a well-functioning sample.
TRIAL REGISTRATION


ClinicalTrials, NCT02538497, Registered 2 September 2015.",2020,"A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness.","['196 women using data from T1 (gestational weeks 13-39), T4 (5-15\u2009weeks postpartum) and T5 (3-9\u2009months postpartum', '220 women and 130 of their partners recruited between 2015 and 2017']",['NBO'],"['parental stress', 'Newborn Behavioral Observation, maternal stress, depressive symptoms', 'maternal depressive symptoms and parental stress using the Edinburgh Postnatal Depression Scale (EPDS) and the Parenting Stress Index (PSI', 'Parental Reflective Functioning Questionnaire (PRFQ), the Maternal Postnatal Attachment Scale (MPAS) and the Maternal Confidence Questionnaire (MCQ', 'Newborn Behavioral Observation (NBO', 'depressive symptoms and parental stress']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}]","[{'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",220.0,0.0440688,"A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness.","[{'ForeName': 'Ragnhild Sørensen', 'Initials': 'RS', 'LastName': 'Høifødt', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway. ragnhild.s.hoifodt@uit.no.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Nordahl', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Inger Pauline', 'Initials': 'IP', 'LastName': 'Landsem', 'Affiliation': 'Division of Child and Adolescent Health, University Hospital of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csifcsák', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bohne', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Gerit', 'Initials': 'G', 'LastName': 'Pfuhl', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Rognmo', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Hanne C', 'Initials': 'HC', 'LastName': 'Braarud', 'Affiliation': 'Department of Social Science, Faculty of Health and Social Science, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Goksøyr', 'Affiliation': 'Department of Social Science, Faculty of Health and Social Science, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Moe', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Slinning', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health East and South, Oslo, Norway.'}, {'ForeName': 'Catharina Elisabeth Arfwedson', 'Initials': 'CEA', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}]",BMC psychiatry,['10.1186/s12888-020-02669-y']
1040,32539740,"Efficacy of ""Family Connections"", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial.","BACKGROUND


Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients' recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants' acceptance). This paper presents the study protocol.
METHODS


The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants' treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed.
DISCUSSION


This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives' and patients' data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04160871. Registered November 15th 2019.",2020,"This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
","['relatives of people with borderline personality disorder (BPD', 'Patients with borderline personality disorder (BPD', 'relatives of people with BPD', 'relatives of people with borderline personality disorder']","['Family Connections', 'Family Connections group (FC) or Treatment As Usual (TAU']","['efficiency and effectiveness', 'BAS and FAD-GFS', 'family attitudes and caregiver burnout', 'DASS-21, FES, GS, and QLI']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015540', 'cui_str': 'Flavin-Adenine Dinucleotide'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4704714', 'cui_str': 'Caregiver Burnout'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]",,0.0896351,"This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fernández-Felipe', 'Affiliation': 'Universitat Jaume I, Castellón, Spain. fernandi@uji.es.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Guillén', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Marco', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Díaz-García', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Jorquera', 'Affiliation': 'ITA-PREVI (Personality Disorders Centre), Castellón, Valencia and Alicante, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Baños', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}]",BMC psychiatry,['10.1186/s12888-020-02708-8']
1041,32546129,A psychological intervention for suicide applied to non-affective psychosis: the CARMS (Cognitive AppRoaches to coMbatting Suicidality) randomised controlled trial protocol.,"BACKGROUND


Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis.
METHODS


The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders.
DISCUSSION


This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03114917), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666); 5th June 2017). Registration was recorded prior to participant recruitment commencing.",2020,The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone.,"['Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment', 'people who have been recently suicidal and have non-affective psychosis', 'suicide applied to non-affective psychosis', 'people with psychosis']","['psychological intervention', 'psychological talking therapy', 'psychological talking therapy (Cognitive Behavioural Suicide Prevention', 'Psychological talking therapies']","['suicidal ideation', 'plus mechanistic, clinical, and health economic outcomes', 'Suicide deaths']","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0001723', 'cui_str': 'Affective psychosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.231865,The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone.,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Gooding', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK. patricia.gooding@manchester.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pratt', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Awenat', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Manchester Centre for Health Economics, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Huggett', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kapur', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lobban', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Haddock', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}]",BMC psychiatry,['10.1186/s12888-020-02697-8']
1042,32546139,Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial.,"BACKGROUND


Alcohol Use Disorder is a severe mental disorder affecting the individuals concerned, their family and friends and society as a whole. Despite its high prevalence, novel treatment options remain rather limited. Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments. In the context of the TRR SFB 265 C04 ""Mindfulness-based relapse prevention as an addition to rtfMRI NFB intervention for patients with Alcohol Use Disorder (MiND)"" study, both interventions will be combined to a state-of-the art intervention that will use mindfulness-based relapse prevention to improve the efficacy of a real-time neurofeedback intervention targeting the ventral striatum, which is a brain region centrally involved in cue-reactivity to alcohol-related stimuli.
METHODS/DESIGN


After inclusion, N = 88 patients will be randomly assigned to one of four groups. Two of those groups will receive mindfulness-based relapse prevention. All groups will receive two fMRI sessions and three real-time neurofeedback sessions in a double-blind manner and will regulate either the ventral striatum or the auditory cortex as a control region. Two groups will additionally receive five sessions of mindfulness-based relapse prevention prior to the neurofeedback intervention. After the last fMRI session, the participants will be followed-up monthly for a period of 3 months for an assessment of the relapse rate and clinical effects of the intervention.
DISCUSSION


The results of this study will give further insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback interventions for the treatment of Alcohol Use Disorder. Additionally, the study will provide further insight on neurobiological changes in the brain caused by the neurofeedback intervention as well as by the mindfulness-based relapse prevention. The outcome might be useful to develop new treatment approaches targeting mechanisms of Alcohol Use Disorder with the goal to reduce relapse rates after discharge from the hospital.
TRIAL REGISTRATION


This trial is pre-registered at clinicaltrials.gov (trial identifier: NCT04366505; WHO Universal Trial Number (UTN): U1111-1250-2964). Registered 30 March 2020, published 29 April 2020.",2020,"Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments.","['WHO Universal Trial Number (UTN', 'alcohol use disorder']","['mindfulness-based relapse prevention prior to the neurofeedback intervention', 'rtfMRI NFB intervention']",[],"[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],88.0,0.0585032,"Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Weiss', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany. franziska.weiss@zi-mannheim.de.'}, {'ForeName': 'Acelya', 'Initials': 'A', 'LastName': 'Aslan', 'Affiliation': 'Department of Addiction Behavior and Addiction Medicine, Central Institute of Mental Health, Heidelberg University/Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}, {'ForeName': 'Martin Fungisai', 'Initials': 'MF', 'LastName': 'Gerchen', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addiction Behavior and Addiction Medicine, Central Institute of Mental Health, Heidelberg University/Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02717-7']
1043,32546148,Effect of assertive case management intervention on suicide attempters with comorbid Axis I and II psychiatric diagnoses: secondary analysis of a randomised controlled trial.,"BACKGROUND


Most suicide attempters suffer from psychiatric disorders, which are often comorbid with personality disorders. The effects of intervention on patients who have attempted suicide with comorbid Axis I and II diagnoses have not been fully elucidated. We evaluated whether assertive case management can reduce the repetition of suicidal behaviours in patients who had attempted suicide with comorbid Axis I and II diagnoses.
METHODS


This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care. Subjects were divided into those who had comorbid Axis I and II diagnoses (Axis I + II group), and those who had an Axis I diagnosis without Axis II comorbidity (Axis I group). Outcome measures were compared between patients receiving a case management intervention and patients receiving enhanced usual care, as allocated. The primary outcome measure was the incidence proportion of the first episode of recurrent suicidal behaviour at 6 months after randomisation. We calculated risk ratios (RR) with 95% confidence intervals (CI) at 6 months and 12 months after randomisation of patients in the Axis I and Axis I + II groups.
RESULTS


Of 914 enrolled patients, 120 (13.1%) were in the Axis I + II group, and 794 (86.9%) were in the Axis I group. Assertive case management was significantly effective for the Axis I group on the primary outcome at 6 months (risk ratio [RR] 0.51, 95% confidence intervals [CI] 0.31 to 0.84). The RR of the Axis I + II group was 0.44 (95% CI 0.14 to 1.40).
CONCLUSIONS


Assertive case management not only had an effect on patients who had attempted suicide with only Axis I disorders but may also have a similar effect on patients with comorbid Axis I and II disorders.",2020,"This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care.","['suicide attempters with comorbid Axis I and II psychiatric diagnoses', 'patients who had attempted suicide with comorbid Axis I and II diagnoses', 'Subjects were divided into those who had comorbid Axis I and II diagnoses (Axis I\u2009+\u2009II group), and those who had an Axis I diagnosis without Axis II comorbidity (Axis I group', 'patients who have attempted suicide with comorbid Axis I and II diagnoses']",['assertive case management intervention'],"['repetition of suicide attempts', 'incidence proportion of the first episode of recurrent suicidal behaviour', 'repetition of suicidal behaviours', 'calculated risk ratios (RR']","[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270287', 'cui_str': 'Axis I diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",914.0,0.0613649,"This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care.","[{'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Norimoto', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Ikeshita', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Okuchi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yonemoto', 'Affiliation': 'Department of Neuropsychopharmacology, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higasi, Kodaira, Tokyo, 187-8551, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Psycho-oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture, Nagaizumi, 411-8777, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Chida', 'Affiliation': 'Department of Neuropsychiatry, Iwate Medical University, 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate-Prefecture, 028-3694, Japan.'}, {'ForeName': 'Shigero', 'Initials': 'S', 'LastName': 'Shimoda', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Hirayasu', 'Affiliation': 'Hirayasu Hospital, 346 Kyozuka, Urasoe, Okinawa, 901-2111, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Neuropsychiatry, Sapporo Medical University Graduate School of Medicine, 291 S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan. chiaki.kawanishi@gmail.com.'}]",BMC psychiatry,['10.1186/s12888-020-02723-9']
1044,32555927,Short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure.,"The objective was to investigate and evaluate the short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure. Forty-nine patients with chronic systolic heart failure during acute decompensation were randomly divided into a levosimendan group (26 cases) and a control group (23 cases). The control group received only routine treatment, while the levosimendan group received a levosimendan bolus with a load of 12 µg/kg, in addition to the same routine treatment as the control group. After 48 hours of treatment, N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in the levosimendan group were significantly lower than those in the control group. In addition, the left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores of the levosimendan group were significantly higher and more improved than those of the control group seven days after treatment, but there was no significant difference in the left ventricular end-diastolic diameter between the two groups. Furthermore, 48 hours after treatment, there were no significant differences in potassium, haemoglobin, haematocrit and creatinine levels between the levosimendan and control groups. During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group. Levosimendan significantly improved NT-proBNP and LVEF in patients with chronic systolic heart failure, and improved NYHA cardiac function classification without significant cardiovascular events. Levosimendan is therefore effective and safe in the short-term treatment of chronic systolic heart failure.",2020,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","['Forty-nine patients with chronic systolic heart failure during acute decompensation', 'patients with chronic systolic heart failure']","['Levosimendan', 'levosimendan', 'levosimendan bolus']","['sudden death', 'hypotension or severe hypokalaemia', 'left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores', 'potassium, haemoglobin, haematocrit and creatinine levels', 'NT-proBNP and LVEF', 'left ventricular end-diastolic diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",49.0,0.0197414,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","[{'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Rui-Bin', 'Initials': 'RB', 'LastName': 'Li', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jia', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Email: zhangjidong78@163.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2020-008']
1045,32539235,Effectiveness of a life story intervention for adults with intellectual disability and depressive and trauma-related complaints.,"INTRODUCTION


People with intellectual disability have a higher chance of developing mental disorders than the general population. Yet, few evidence-based interventions exist. This article evaluates My Lifestory, a narrative intervention tailored to people with intellectual disability and depressive or trauma-related complaints.
METHOD


A quasi-experimental research design was adopted with an experimental condition (My Lifestory) and a matched control condition (care as usual). Measurements took place before the intervention, at the end of the intervention and at follow-up two months later. Measurements focused on psychiatric complaints, well-being, life satisfaction, mastery, and purpose in life.
RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition. Effect sizes were large in the intervention condition and small in the control condition.
DISCUSSION


Despite some limitations, this study adds to the evidence base of this narrative intervention.",2020,"RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition.","['people with intellectual disability and depressive or trauma-related complaints', 'adults with intellectual disability and depressive and trauma-related complaints', 'People with intellectual disability']",['life story intervention'],"['psychiatric complaints, well-being, life satisfaction, and purpose in life', 'psychiatric complaints, well-being, life satisfaction, mastery, and purpose in life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]",,0.0387123,"RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition.","[{'ForeName': 'Janny', 'Initials': 'J', 'LastName': 'Beernink', 'Affiliation': 'Dokter Bosman Mental Health Care, Doetinchem, The Netherlands.'}, {'ForeName': 'Gerben J', 'Initials': 'GJ', 'LastName': 'Westerhof', 'Affiliation': 'Psychology, Health, and Technology, University of Twente, Enschede, The Netherlands.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12754']
1046,32540321,Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.,"PURPOSE


Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.
PATIENTS AND METHODS


The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.
RESULTS


A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).
CONCLUSIONS


The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.",2020,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","['A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group', 'patients with HNC who had undergone microvascular reconstruction from 2008 through 2013', 'Reconstructive Head and Neck Cancer Surgery', 'patients with head and neck cancer (HNC']","['perioperative DEX', 'DEX', 'no DEX', 'Perioperative Dexamethasone', 'perioperative dexamethasone (DEX']","['overall survival rate', 'death', 'deaths', 'Charlson comorbidity index (CCI', 'advanced disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",93.0,0.0680807,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Kainulainen', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. Electronic address: satu.kainulainen@hus.fi.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Consultant, Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Koivusalo', 'Affiliation': 'Consultant and Docent, Department of Anesthesia and Intensive Care Unit, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wilkman', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Professor Emeritus, Department of Health and Social Management, University of Eastern Finland, Kuopio; and Professor Emeritus, Group Administration, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Consultant, Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Törnwall', 'Affiliation': 'Docent, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lassus', 'Affiliation': 'Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.004']
1047,32536111,Hemodynamics in young athletes following high-intensity interval or moderate-intensity continuous training.,"BACKGROUND


The present study aimed to investigate the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on blood pressure (BP) and parameters of arterial stiffness in young athletes.
METHODS


Seventeen rowers (aged 15±1.3 years) were randomized into an intervention group (IG, N.=10) and the control group (CG, N.=7). During an 8-week intervention period, the IG completed a HIIT on the rowing ergometer twice-weekly (2×4×2 min at ≈95% of maximum heart rate [HR<inf>max</inf>], 60 s rest) in addition to the regular rowing training (3×/week MICT 70-90 min, ≈70% HR<inf>max</inf>). The CG completed the regular normal rowing training and, instead of the HIIT units, two additional MICT units (70-90 min, ≈70% HR<inf>max</inf>). Before and after the intervention period, hemodynamic parameters were recorded non-invasively in both groups.
RESULTS


After the intervention period, there was a significant decrease in peripheral systolic (P=0.01) and diastolic (P=0.05) BP, as well as in central systolic (P=0.05) and diastolic BP (P=0.03) in the IG. Furthermore, pulse wave velocity (PWV) (P=0.05) was significantly reduced. Analysis of intervention effects revealed significant between-group differences in central diastolic BP (P=0.05), in augmentation pressure (P=0.02), and in augmentation index (P=0.006) favoring IG. The CG showed no significant changes in the respected parameters throughout the intervention.
CONCLUSIONS


Already in adolescent athletes, a HIIT intervention has beneficial effects on peripheral and central BP as well as on PWV, augmentation pressure, and augmentation index.",2020,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","['young athletes', 'adolescent athletes', '17 rowers (aged 16±1.4 years', 'young athletes following high-intensity interval or moderate-intensity continuous training']","['control group (CG', 'HIIT intervention', 'HIIT versus moderate-intensity continuous training (MICT', 'regular rowing training']","['central diastolic BP', 'augmentation pressure', 'diastolic BP', 'central systolic', 'pulse wave velocity', 'diastolic', 'augmentation index', 'blood pressure (BP) and parameters of arterial stiffness', 'peripheral systolic', 'hemodynamic parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0222633,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Institute of Sports Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany - sascha.ketelhut@gmail.com.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Kirchenberger', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard G', 'Initials': 'RG', 'LastName': 'Ketelhut', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10814-4']
1048,32545655,Effect of C242T Polymorphism in the Gene Encoding the NAD(P)H Oxidase p22 phox  Subunit and Aerobic Fitness Levels on Redox State Biomarkers and DNA Damage Responses to Exhaustive Exercise: A Randomized Trial.,"NAD(P)H oxidases (NOXs) constitute a principal source of cellular reactive oxygen species (ROS) and contribute to exercise-induced ROS production in the skeletal muscle. Here, we aimed to investigate the effect of single-bout exhaustive exercise on redox state biomarkers and oxidative DNA damage based on the C242T polymorphism in the gene encoding NOXs subunit p22 phox  ( CYBA ) and aerobic fitness levels. We enrolled 220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110), who were divided into CC genotype and T allele groups through the analysis of the  CYBA  C242T polymorphism. Furthermore, maximum oxygen uptake (VO 2 max) was evaluated to divide subjects into high fitness (HF; 70th percentile for aerobic fitness) and mid-range fitness (MF; 40-60th percentile for aerobic fitness) groups, with a total of 32 subjects assigned to four groups (eight subjects per group): CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF). All subjects performed treadmill running exercise at 85% of VO 2 max until exhaustion. Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM]) were measured in the blood samples obtained immediately before (IBE), immediately after (IAE), and 30 min after exercise (30 MAE). Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05). All groups displayed increased plasma MDA levels at IAE rather than at IBE, with CC + MF being significantly higher than T + HF ( p  < 0.05); only the CC + HF and T + HF groups exhibited a significant reduction at 30 MAE ( p  < 0.05). Moreover, TL at IAE was significantly higher in the CC + MF group than in the T + HF group ( p  < 0.05), and significantly higher in the CC + MF and CC + HF groups than in the T + HF group at 30 MAE ( p  < 0.05). TM was significantly higher in the T + MF than in the T + HF group at IAE ( p  < 0.05) and that of CC + MF was significantly higher than CC + HF and T + HF values at IAE and 30 MAE ( p  < 0.05). These results suggest that single-bout exhaustive exercise could induce peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage. Moreover, high aerobic fitness levels combined with the T allele may protect against exercise-induced redox imbalance and DNA damage.",2020,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","['220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110']","['C242T Polymorphism', 'treadmill running exercise', 'CC + MF', 'CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF', 'single-bout exhaustive exercise']","['peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage', 'plasma MDA levels', 'Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM', 'Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM', 'TM', 'TL at IAE', 'maximum oxygen uptake (VO 2 max']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1272145', 'cui_str': 'Plasma lactate level'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",220.0,0.020247,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","[{'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Exercise Physiology Laboratory, Department of Physical Education, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17124215']
1049,32557665,Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study.,"We describe outcomes from the first-in-human study of garetosmab (a fully human monoclonal antibody that inhibits activin A) under development for the treatment of fibrodysplasia ossificans progressiva (FOP). In a double-blind, placebo-controlled phase 1 study, 40 healthy women of nonchildbearing potential were randomized to receive a single dose of intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo. Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies were measured predose and up to 113 days post-first dose. Garetosmab demonstrated an acceptable safety profile with no dose-limiting toxicities. Garetosmab displayed nonlinear pharmacokinetics with target-mediated elimination. With increasing doses of intravenous garetosmab, mean peak concentration increased in a dose-proportional manner; mean steady-state estimates ranged from 41.4 to 47.8 mL/kg. A greater than dose-proportional increase in mean area under the concentration-time curve from time zero extrapolated to infinity (range, 72.2-7520 mg*day/L) was observed, consistent with decreasing mean clearance (range, 4.35-1.34 mL/day/kg). Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner. At 10 mg/kg, total activin A levels reached a state of little or no change between weeks 4 and 12, suggesting saturation of the target-mediated pathway. No safety signals were seen in this study to preclude investigation in patients. Following intravenous administration, garetosmab concentrations decreased quickly, then decreased over time (reflecting linear elimination), and finally decreased in a nonlinear phase, reflecting target-mediated elimination. Results here support further investigation. Garetosmab 10 mg/kg every 4 weeks intravenously is being evaluated in patients with FOP (NCT03188666).",2020,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.",['40 healthy women of nonchildbearing potential'],"['placebo', 'intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo', 'Garetosmab (Anti-Activin A']","['mean concentrations of total activin A', 'total activin', 'mean peak concentration', 'Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies', 'mean clearance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",40.0,0.164094,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Clinical Pharmacology Unit, Antwerp, Belgium.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Tiera', 'Initials': 'T', 'LastName': 'Drewery', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'DelGizzi', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Forleo-Neto', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Herman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1638']
1050,32550713,Ischemic preconditioning improves performance and accelerates the heart rate recovery.,"BACKGROUND


Previous studies have assessed the effects of ischemic preconditioning (IPC) on exercise performance and physiological variables, such as lactate and muscle deoxygenation. In this study, we verified the IPC effects on performance and heart rate during and immediately after a maximal incremental cycling test (ICT).
METHODS


Eighteen recreationally trained cyclists (28±4 years) were allocated to one of three groups: IPC, SHAM and Control. After the first visit to familiarization, cyclists attended the laboratory on two separate occasions to perform an ICT: in the 1<sup>st</sup> visit they performed the reference test (baseline), and in 2<sup>nd</sup> the test ischemic preconditioning (2 cycles of 5-min occlusion [at 50 mm Hg above systolic arterial pressure]/ 5-min reperfusion), SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions (post intervention). During the ICT, heart rate, power output and perceived exertion were measured and the heart rate was monitored throughout the recovery.
RESULTS


Only ischemic preconditioning group improved performance time by 4.9±4.0% and decreased heart rate at submaximal point during ICT, of 170±8 to 166±8 bpm (P<0.05). Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151±9 to 145±8 bpm; P<0.05), compared to baseline. No differences for other parameters were found.
CONCLUSIONS


Two cycles of five minutes of ischemia were relevant to produce positive effects on performance and alter the heart rate during and soon after ICT.",2020,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.",['Eighteen recreationally trained cyclists (28 ± 4 years'],"['ischemic preconditioning (IPC', 'IPC, SHAM and Control', 'Ischemic preconditioning', 'SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions', 'IPC']","['heart rate, power output and perceived exertion', 'performance time', 'heart rate', 'heart rate recovery', 'heart rate and performance']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",18.0,0.164322,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.","[{'ForeName': 'Rhaí A', 'Initials': 'RA', 'LastName': 'Arriel', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Meireles', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Hohl', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Marocolo', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil - isamjf@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10822-3']
1051,32560681,Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study - study protocol.,"BACKGROUND


Social inclusion is essential for an adequate rehabilitation process for people with serious mental illness (SMI). Various supported housing settings aim to promote housing competencies and social inclusion in service users. Nevertheless, there is a strong preference in service users for independent living. We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
METHODS


This is a prospective multi-centre, four-arm, non-inferiority cohort study investigating the effectiveness and efficiency of IHS and RCS/TAU for people with SMI. Effectiveness will be measured by a standardised measure of social inclusion as primary outcome as well as by measures of functioning and well-being. Efficiency will be analysed on the basis of service usage and costs associated with the different housing settings. Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24 months. At one study site, 56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants.
DISCUSSION


While the UN Convention of the Rights of People with Disabilities aims to promote the opportunity to choose one's place of residence, the limited supply of alternative forms of housing does not guarantee genuine freedom of choice. Increased diversification and flexibility of housing support is essential. If IHS shows non-inferiority in terms of their effectiveness and efficiency, users should be allowed to choose their kind of housing support.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03815604, December 04, 2019.",2020,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
","['Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24\u2009months', 'service users', 'people with serious mental illness (SMI', 'non-homeless individuals with severe mental illness', 'two cities in Switzerland', 'people with SMI', '56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants']","['IHS and RCS/TAU', 'Housing and Support (IHS']",[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],112.0,0.238054,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adamus', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland. christine.adamus@upd.unibe.ch.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Mötteli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Richter', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland.'}]",BMC psychiatry,['10.1186/s12888-020-02712-y']
1052,32564340,A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies.,"INTRODUCTION


Clinicians, payers, guideline committees, and policymakers support the use of high-intensity statins in patients at high risk for complications of cardiovascular disease (CVD). Guidelines and recommendations provide guidance on next steps for patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant. Ezetimibe and evolocumab improve CV outcomes when added to statins in high-CV-risk populations. The aim of the study was to compare evolocumab and ezetimibe for lipid-lowering efficacy and safety.
METHODS


We summarized data from 1427 patients from three phase 3 evolocumab studies comparing double-blinded evolocumab vs. ezetimibe. These studies evaluated four distinct populations: those free of CVD receiving each agent as monotherapy, patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients. Lipid efficacy and safety were reported at week 12.
RESULTS


Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001). This corresponded to absolute reductions in LDL-C of 60-104 mg/dL with evolocumab vs. 17-35 mg/dL with ezetimibe. Evolocumab also significantly improved other lipids and led to a higher percentage of patients achieving LDL-C goals vs. ezetimibe. Adverse events and discontinuation rates (oral and parenteral therapy) were balanced across groups, suggesting good tolerance and acceptance of both treatments.
CONCLUSIONS


Evolocumab outperformed ezetimibe in efficacy and lipid goal attainment. Both products demonstrated good safety/tolerability. These data may help guide access decisions for high-risk patients with inadequate treatment response or intolerance to statin therapy.",2020,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","['patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients', 'patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant', 'patients at high risk for complications of cardiovascular disease (CVD', 'Four Patient Populations', 'high-risk patients with inadequate treatment response or intolerance to statin therapy', '1427 patients from three phase 3 evolocumab studies comparing double-blinded']","['ezetimibe', 'evolocumab and ezetimibe', 'evolocumab vs. ezetimibe', 'Ezetimibe and evolocumab', 'Ezetimibe and Evolocumab']","['CV outcomes', 'Lipid efficacy and safety', 'good safety/tolerability', 'LDL-C', 'Adverse events and discontinuation rates (oral and parenteral therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",1427.0,0.170858,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, 4085 University Blvd. South, Suite 1, Jacksonville, FL, 32216, USA. mkoren@encoredocs.com.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Jones', 'Affiliation': 'Baylor College of Medicine, 6655 Travis St., Suite 320, Houston, TX, 77030, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, 145 N. Riverside Dr, Iowa City, IA, 52246, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Clinical Biochemistry, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Cleveland Clinic, 9500 Euclid Ave., Desk JB1, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hucko', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'Lopez', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Alex N', 'Initials': 'AN', 'LastName': 'Fleishman', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Ransi', 'Initials': 'R', 'LastName': 'Somaratne', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stroes', 'Affiliation': 'Academic Medical Center of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands.'}]",Cardiology and therapy,['10.1007/s40119-020-00181-8']
1053,32558709,Pitfalls in the Detection of Insulinomas With Glucagon-Like Peptide-1 Receptor Imaging.,"PURPOSE


Physiological pancreaticoduodenal uptake of radiolabeled exendin-4 in Brunner glands of the proximal duodenum is the most common pitfall for false interpretation of glucagon-like peptide-1 receptor (GLP-1R) imaging. The aim of this study was to analyze the pancreaticoduodenal uptake in GLP-1R PET/CT and SPECT/CT images and to identify additional potential reading pitfalls in patients with suspected insulinoma.
METHODS


A post hoc analysis of a prospective study, including 52 consecutive patients, was performed. All patients underwent 1 Ga-exendin-4 PET/CT and 2 In-exendin-4 SPECT/CT scans (4 and 72 hours postinjection) in a randomized crossover order. Three board-certified nuclear medicine physicians read all scans independently. They were unaware of other results. Reference standard was surgery with histopathological confirmation of an insulinoma/nesidioblastosis and normalization of blood glucose levels after surgery.
RESULTS


There were no false-positive readings. However, there were a number of false-negative PET/CT and SPECT/CT readings, respectively: (1) due to false interpretation of uptake in the pancreaticoduodenal region (falsely interpreted as physiological uptake in Brunner glands instead of an insulinoma in 0.6% vs 9.0%), (2) due to ectopic insulinoma (0% vs 2.6%), (3) due to small insulinoma (1.9% vs 5.1%), (4) due to insulinoma overlap with kidneys (1.9% vs 4.5%), and (5) due to nesidioblastosis (0.6% and 1.9%). Pitfalls were identified in all GLP-1R PET/CT and SPECT/CT scans.
CONCLUSIONS


Peripancreatic uptake, small size of an insulinoma, insulinoma overlap with kidneys, and presence of nesidioblastosis are potential pitfalls in GLP-1R imaging, which can lead to false reading results.",2020,There were no false-positive readings.,"['patients with suspected insulinoma', '52 consecutive patients, was performed']",['GLP-1R PET/CT and SPECT/CT images'],"['blood glucose levels', 'ectopic insulinoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C3472245', 'cui_str': 'Single photon emission computed tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}]",52.0,0.0465109,There were no false-positive readings.,"[{'ForeName': 'Kwadwo', 'Initials': 'K', 'LastName': 'Antwi', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hepprich', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Müller', 'Affiliation': 'Faculty of Clinical Medicine, University of Basel, Basel.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Reubi', 'Affiliation': 'Division of Cell Biology and Experimental Cancer Research, Institute of Pathology, University of Bern, Bern.'}, {'ForeName': 'Melpomeni', 'Initials': 'M', 'LastName': 'Fani', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Rottenburger', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Nicolas', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kaul', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Emanuel R', 'Initials': 'ER', 'LastName': 'Christ', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Wild', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003124']
1054,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
1055,32546726,Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.,"CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m 2  on days 1, 3, and 5. Once safety was established, a 100 units/m 2  arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m 2  arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lowest with 50 units/m 2  (19%) compared with 75 units/m 2  (38%) and 100 units/m 2  (44%) (P = 0.35). The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04). Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia (34%), pneumonia (23%), and sepsis (16%). CPX-351 at 75 units/m 2  has favorable safety and efficacy for AML patients at high risk of induction mortality with some tolerating the standard dose of 100 units/m 2 .",2020,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","['patients with acute myeloid leukemia at high risk for induction mortality', 'Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100\u2009units/m 2  arms, respectively', 'patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial']","['cytarabine/daunorubicin', 'CPX-351']","['median OS', 'safety and efficacy', 'Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia', 'composite complete remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",56.0,0.0785846,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","[{'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Prithviraj', 'Initials': 'P', 'LastName': 'Bose', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kornblau', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. jorge.cortes@augusta.edu.'}]",Leukemia,['10.1038/s41375-020-0916-8']
1056,32546220,Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['severely ill adults with COVID-19'],['human anti-SARS-CoV-2 convalescent plasma'],['efficacy and safety'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0823071,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04504-x']
1057,32553411,Usefulness of the alpha maneuver in the peritoneal catheter displacement: review and experience.,"INTRODUCTION AND OBJECTIVES


Peritoneal catheter displacement is one of the most common complications of peritoneal dialysis. The alpha manoeuvre has been proposed as a repositioning technique, which involves returning the catheter to its correct position using rigid guidewires under fluoroscopic guidance. The aim of this study is to analyse the 107 procedures performed at our Centre to identify factors that may predict the success of the technique.
MATERIAL AND METHODS


The alpha manoeuvre method was used in 86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres).
RESULTS


The overall success rate of the technique was 60%. There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter. There was only one case of peritonitis related to the procedure.
CONCLUSIONS


The alpha manoeuvre is an effective and safe method for correcting peritoneal catheter displacement.",2020,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","['86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres']",[],"['time of catheter failure', 'success rate', 'overall success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0223798,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Río García', 'Affiliation': 'Hospital San Agustín, Avilés, España. Electronic address: lauri_rio@hotmail.com.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Merino Bueno', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Alcuria Ledo', 'Affiliation': 'Hospital San Agustín, Avilés, España.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Álvarez Santamarta', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rodríguez Suárez', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sánchez Álvarez', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.03.006']
1058,32554025,swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an Rpackage swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1059,32554067,Dexmedetomidine Provides Fewer Respiratory Events Compared With Propofol and Fentanyl During Third Molar Surgery: A Randomized Clinical Trial.,"PURPOSE


Propofol and fentanyl can cause airway obstruction and respiratory depression when used together for intravenous sedation. This study investigated whether dexmedetomidine and midazolam would decrease respiratory events requiring intervention during deep sedation compared with propofol, fentanyl, and midazolam.
PATIENTS AND METHODS


A prospective, randomized, double-blinded, controlled trial was designed to assess 2 intravenous treatment groups during third molar surgery. Patients were randomized into 2 groups. The control group (group P) received 0.8 μg/kg of fentanyl followed by propofol infusion at 125 μg/kg per minute over a 10-minute period with intraoperative boluses of 0.1 μg/kg. The study group (group D) received dexmedetomidine bolus infusion of 1 μg/kg over a 10-minute period followed by maintenance infusion at 0.5 μg/kg per hour. Both groups were given 0.03 mg/kg of midazolam before infusion. Scorers, masked to group, viewed the procedure remotely and evaluated the primary outcome variable of respiratory events requiring intervention. Secondary outcome variables evaluated by the scorers included the Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15 minutes, and time to ambulation and discharge. Patient satisfaction and hemodynamic stability were measured. The difference between groups regarding the occurrence of respiratory events was tested using the Fisher exact test, and mixed-effects models were used to compare repeated vital signs.
RESULTS


The sample was composed of 141 patients randomly assigned to either group P (n = 67) or group D (n = 74). No statistically significant differences in the distribution of study variables were found between groups at baseline. A statistically significant difference in respiratory events requiring deliberate intervention existed between group P (25.4%) and group D (2.7%) (P < .0001). No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
CONCLUSIONS


Using dexmedetomidine and midazolam for outpatient surgery resulted in fewer respiratory events requiring deliberate intervention compared with propofol, fentanyl, and midazolam. Ambulation and discharge times were not prolonged using dexmedetomidine.",2020,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
",['141 patients randomly assigned to either group P (n\xa0=\xa067) or group D'],"['dexmedetomidine bolus infusion of 1\xa0μg/kg over a 10-minute period followed by maintenance infusion', 'Dexmedetomidine', 'Propofol and Fentanyl', 'Propofol and fentanyl', 'fentanyl followed by propofol infusion', 'propofol, fentanyl, and midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['occurrence of respiratory events', 'Respiratory Events', 'respiratory events', 'Patient satisfaction and hemodynamic stability', 'Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction', 'Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15\xa0minutes, and time to ambulation and discharge', 'Ambulation and discharge times']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}]",141.0,0.396816,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Nolan', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY. Electronic address: PNOLAN@montefiore.org.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Delgadillo', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Youssef', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Professor of Biomedical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Chehrehsa', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.015']
1060,32562440,Evaluation and improvement of blood donor educational materials: results from a multicenter randomized controlled trial.,"BACKGROUND


Blood collection centers are charged with creating donor educational materials (DnEM) that are easily understood across all prospective donor populations, while addressing mandates and recommendations from regulatory agencies and professional standard setting organizations. Donors must have sufficient information to understand the donation process with its risks and benefits, time to consider options before deciding, and opportunity to choose whether to proceed with or decline donating. The goal of this multisite randomized controlled trial was to evaluate knowledge acquired using standardized DnEM. America's Blood Centers' Working Group (WG) for Donor Education and Communication was formed to evaluate and suggest modifications of these documents. Based on pilot work, a randomized clinical trial was designed to test donor knowledge across a variety of populations. The WG identified several shortcomings in the current DnEM and proposed new DnEM. The new DnEM were tested against the same, current DnEM being used at all three sites (Blood Donor Educational Material, 2016 version 2.0, published in conjunction with the AABB uniform donor history questionnaire).
METHODS AND MATERIALS


One-hundred sixty-five first time and returning donors were randomized in a 2x2 model to review either new DnEM or current DnEM. Every participant completed a pre- and post-quiz that tested their understanding of the DnEM.
RESULTS


Returning donors had greater baseline knowledge compared to new donors, but new donors improved more versus returning donors. Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
CONCLUSION


Comprehension of DnEM can be improved. With this sample size the results suggest that the findings are independent of demographic characteristics, but a larger study would be necessary to confirm this.",2020,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
",['One-hundred sixty-five first time and returning donors'],['new DnEM or current DnEM'],['blood donor educational materials'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.0582905,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
","[{'ForeName': 'Gay', 'Initials': 'G', 'LastName': 'Wehrli', 'Affiliation': 'University of Virginia Health, Charlottesville, Virginia, USA.'}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Rossmann', 'Affiliation': 'Gulf Coast Regional Blood Center, Houston, Texas, USA.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Waxman', 'Affiliation': 'Versiti, Indianapolis, Indiana, USA.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Katz', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa, USA.'}]",Transfusion,['10.1111/trf.15866']
1061,32558287,Heart failure patients with atrial fibrillation benefit from remote patient management: insights from the TIM-HF2 trial.,"AIMS


Atrial fibrillation (AF) is a frequent comorbidity in patients with heart failure (HF). HF patients with AF are characterized by high morbidity and increased risk of hospitalizations. We assessed the effects of remote patient management (RPM) in HF patients with AF compared with usual care (UC) in the TIM-HF2 trial.
METHODS AND RESULTS


For this post-hoc analysis, AF status at randomization was assessed in 1537 patients with HF. The primary outcome was the percentage of days lost due to unplanned cardiovascular hospital admissions or death of any cause. Around 966 patients had sinus rhythm (SR) and 571 had AF. The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001). AF patients had more days lost due to unplanned cardiovascular hospitalization than SR patients (7.53%, CI 6.01-9.05 vs. 4.90%, CI 3.98-5.82, ratio 1.54, P = 0.004) and higher all-cause mortality (11.9%, CI 9.4-14.9 vs. 8.5%, CI 6.8-10.4, HR 0.66, CI 0.47-0.94, P = 0.029). Patients with AF randomized to RPM had significantly less days lost due to unplanned cardiovascular hospital admissions or all-cause death (5.64%, CI 3.81-7.48) than patients with AF randomized to UC (9.37%, CI 6.98-11.76, ratio 0.60, P = 0.015). No difference was seen in SR patients (UC: 5.25%, CI 3.93-6.58, RPM: 4.55%, CI 3.27-5.83, ratio 0.87, P = 0.452). All-cause mortality in AF patients was reduced with 9.2% (CI 6.1-13.2) in the RPM group compared with 14.5% (CI 10.7-18.1) in the UC group (HR 0.60, CI 0.36-1.00, P = 0.050).
CONCLUSIONS


For patients with atrial fibrillation at study entry, RPM was associated with increased days alive out of hospital. Our results identify HF patients with atrial fibrillation as a promising target population for RPM.",2020,The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001).,"['966 patients had sinus rhythm (SR) and 571 had AF', '1537 patients with HF', 'HF patients with AF', 'Heart failure patients with atrial fibrillation benefit from remote patient management', 'HF patients with atrial fibrillation', 'HF patients with AF compared with usual care (UC) in the TIM-HF2 trial', 'patients with heart failure (HF']","['RPM', 'remote patient management (RPM']","['unplanned cardiovascular hospital admissions or all-cause death', 'unplanned cardiovascular hospitalization', 'heart rhythm and all-cause mortality', 'risk of hospitalizations', 'cause mortality', 'percentage of days lost due to unplanned cardiovascular hospital admissions or death of any cause']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",1537.0,0.132013,The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Stegmann', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moeller', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Zeynalova', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology, (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}]",ESC heart failure,['10.1002/ehf2.12819']
1062,32562195,Health-related quality of life and physical activity level after a behavior change program at Norwegian healthy life centers: a 15-month follow-up.,"PURPOSE


The long-term impact of primary care behavior change programs on health-related quality of life (HRQoL) and physical activity (PA) level is unknown. The aim of this study was to investigate changes in HRQoL and PA among participants after a 3-month behavior change intervention at Norwegian healthy life center (HLCs) and at a 15-month follow-up. Furthermore, we aimed to study associations between changes in PA and HRQoL.
METHODS


We followed 524 adult participants (18-83 years), recruited from 32 HLCs in August 2016-January 2018, who provided data on HRQoL (SF-36) and PA (ActiGraph accelerometers) 12 months after a 3-month behavior change intervention. Changes in HRQoL and PA between baseline, 3-month and 15-month follow-ups, and associations between changes in PA and HRQoL were analyzed by linear mixed models.
RESULTS


All HRQoL dimensions improved from baseline to 3-month follow-up, and the improvements maintained at 15-month follow-up (mean 3.1-13.1 points, p < 0.001). PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001). We observed positive associations between changes in PA and HRQoL (0.84-3.23 points per 1000 steps/day, p < 0.023).
CONCLUSIONS


Twelve months after completing a 3-month HLC intervention we found improved HRQoL, but not PA level. Still, there were positive associations between PA and HRQoL over this period, indicating that participants increasing their PA were more likely to improve their HRQoL.",2020,"PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001).","['524 adult participants (18-83\xa0years), recruited from 32 HLCs in August 2016-January 2018, who provided data on HRQoL (SF-36) and PA (ActiGraph accelerometers) 12\xa0months after a 3-month behavior change intervention', 'participants after a 3-month behavior change intervention at Norwegian healthy life center (HLCs) and at a 15-month follow-up', 'Norwegian healthy life centers']","['HRQoL', 'primary care behavior change programs']","['Health-related quality of life and physical activity level', 'HRQoL', 'PA', 'HRQoL and PA', 'All HRQoL dimensions', 'health-related quality of life (HRQoL) and physical activity (PA) level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",524.0,0.0265546,"PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001).","[{'ForeName': 'Ellen Eimhjellen', 'Initials': 'EE', 'LastName': 'Blom', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway. ellen.blom@hvl.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Aadland', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway.'}, {'ForeName': 'Guri Kaurstad', 'Initials': 'GK', 'LastName': 'Skrove', 'Affiliation': 'Department of Social Sciences, Møreforsking Molde AS, Britvegen 4, 6410, Molde, Norway.'}, {'ForeName': 'Ane Kristiansen', 'Initials': 'AK', 'LastName': 'Solbraa', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway.'}, {'ForeName': 'Line Merethe', 'Initials': 'LM', 'LastName': 'Oldervoll', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, 7491, Trondheim, Norway.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02554-x']
1063,32562206,Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.,"BACKGROUND AND OBJECTIVE


In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy?
METHODS


The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor.
RESULTS


Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy).
CONCLUSIONS


Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS.
GOV UNIQUE IDENTIFIER


NCT02164864.",2020,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","['patients with atrial fibrillation who underwent percutaneous coronary intervention', 'patients receiving/not receiving a proton pump inhibitor', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation following percutaneous coronary intervention', 'Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline', '2725 patients with atrial fibrillation post-percutaneous coronary intervention to']","['warfarin triple therapy', 'dabigatran dual therapy', 'Dabigatran', 'clopidogrel or ticagrelor', 'Proton Pump Inhibitor', 'warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin', 'proton pump inhibitor', 'Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention']","['risk of major bleeding events', 'risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",2725.0,0.0706981,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Sulzbach (Taunus), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148, Paris, France.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-020-01323-x']
1064,32568935,Apoyo con Cariño: A Qualitative Analysis of a Palliative Care-Focused Lay Patient Navigation Intervention for Hispanics With Advanced Cancer.,"A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado. Five home visits were delivered over 3 months to 112 patients assigned to the randomized controlled trial's intervention arm. Grounded in core Hispanic values, visits addressed palliative care domains (advance care planning, pain/symptom management, and hospice utilization). To describe the content of patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients. Based on previous work, codes were established a priori to identify ways patient navigators help patients/family caregivers. Key words and comments from field notes were classified into themes using ATLAS.ti and additional codes established. Nine common themes and exemplars describing the lay patient navigator role are described: activation/empowerment, advocacy, awareness, access, building rapport, providing support, exploring barriers, symptom screening, and the patient experience. Patient navigators used advocacy, activation, education, and motivational interviewing to address patient/family concerns and reduce barriers to quality palliative care in urban and rural settings. Adapting and implementing this model across cultures has potential to improve palliative care access to underserved populations.",2020,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"['Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado', ""patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients"", 'Hispanics With Advanced Cancer', 'urban and rural settings']","['culturally tailored intervention', 'Palliative Care-Focused Lay Patient Navigation Intervention']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]",[],,0.0265818,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"[{'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Fink', 'Affiliation': 'Regina M. Fink, PhD, APRN, CHPN, FAAN, is professor and codirector, Interprofessional Master of Science in Palliative Care Program, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Danielle M. Kline, MS, is senior professional research assistant, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Shaunna Siler, PhD, RN, is palliative care & aging research fellow and T-32 scholar, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Stacy M. Fischer, MD, is associate professor, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Kline', 'Affiliation': ''}, {'ForeName': 'Shaunna', 'Initials': 'S', 'LastName': 'Siler', 'Affiliation': ''}, {'ForeName': 'Stacy M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000666']
1065,32577819,Switching from Warfarin to rivaroxaban induces sufficiency of vitamin K and reduction of arterial stiffness in patients with atrial fibrillation.,"Use of chronic vitamin K antagonist (VKA) induces a long-term deficiency of vitamin K, which may cause arterial stiffness and bone-related disease. Switching from VKA to rivaroxaban could induce rapid sufficiency of vitamin K and improvement of arterial stiffness. The K2 SUMMIT-3 study is a multicenter, open-label, prospective, and randomized design. Patients with atrial fibrillation who have been taking VKA for more than 6 months but less than 10 years were randomly assigned to two groups; those switching from VKA to rivaroxaban and those continuing with VKA medication. The primary endpoint was the percentage difference of brachial-ankle pulse wave velocity (baPWV) in 3 months. A total of 77 patients were randomly assigned to receive rivaroxaban (n = 38) or VKA (n = 39). The average age was 74 ± 9 years. The duration for which VKA was prescribed prior to randomization was 90 ± 87 months.Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency were observed in 100% or 82% of the patients at baseline but it reduced to 2% (p < 0.0001) or 55% (p = 0.01) at 3 months in the rivaroxaban group. To the contrary, theses data had no changes in the VKA group. The percentage difference in baPWV was - 1.4 ± 10.0% vs. 3.5 ± 14.7% in the rivaroxaban and the VKA groups, respectively. (p = 0.02). Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.",2020,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"['Patients with atrial fibrillation who have been taking VKA for more than 6\xa0months but less than 10\xa0years', 'A total of 77 patients', 'patients with atrial fibrillation']","['rivaroxaban', 'VKA', 'chronic vitamin K antagonist (VKA']","['Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency', 'arterial stiffness', 'rapid sufficiency of vitamin K and reduction of arterial stiffness', 'percentage difference of brachial-ankle pulse wave velocity (baPWV', 'baPWV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C1299351', 'cui_str': 'Abnormally high'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0950248', 'cui_str': 'Des-gamma-carboxy prothrombin'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",77.0,0.0510437,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan. ikari@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Fumie', 'Initials': 'F', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kiyooka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Ebina General Hospital, Ebina, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Tokai University Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Furuki', 'Affiliation': 'Hadano South Gate Clinic, Hadano, Japan.'}, {'ForeName': 'Shigemitsu', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01651-8']
1066,32574773,Macular and Peripapillary Optical Coherence Tomography Angiography Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE


To identify optical coherence tomography angiography (OCTA)-derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression.
DESIGN


Secondary analysis of clinical trial data.
METHODS


This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b study (Aerpio Pharmaceuticals), a multicenter clinical trial for patients with moderate-to-severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral-domain OCT, and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, nonperfusion area, vessel density (VD), and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in 4 quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥2-step increase in DR severity scale score or development of diabetic macular edema.
RESULTS


Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pretreatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
CONCLUSIONS


FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Custo Greig', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009']
1067,32583931,The effect of bright light therapy on depressive symptoms in adults with intellectual disabilities: Results of a multicentre randomized controlled trial.,"BACKGROUND


Although a large number of adults with intellectual disabilities have depressive symptoms, non-pharmacological treatments are scarce. The present authors investigated whether bright light therapy (BLT) is effective in decreasing depressive symptoms compared to care as usual.
METHODS


This multicentre randomized controlled trial consisted of three study groups (10,000 lux BLT, dim light BLT and a no-BLT group). Participants received BLT for 30 min in the morning (14 consecutive days), additional to their regular care. Primary outcome was as follows: depressive symptoms measured with the ADAMS Depressive Mood subscale 1 week after the end of BLT (same time period in the no-BLT group).
RESULTS


Forty-one participants were included in our trial. In both BLT groups, a significant decrease in depressive symptoms was seen. No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451). A minimum amount of side effects and no adverse events were reported.
CONCLUSIONS


In both BLT interventions, a decrease in depressive symptoms was seen. With 10,000 lux BLT, depressive symptoms decreased even below the clinical cut-off point, which makes BLT a promising intervention for clinical practice.",2020,"No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451).","['Forty-one participants were included in our trial', 'adults with intellectual disabilities']","['BLT', 'bright light therapy (BLT', 'bright light therapy']","['Depressive Mood subscale', 'follows: depressive symptoms measured with the ADAMS', 'depressive symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}]",41.0,0.134288,"No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451).","[{'ForeName': 'Pauline C M', 'Initials': 'PCM', 'LastName': 'Hamers', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dederieke A M', 'Initials': 'DAM', 'LastName': 'Festen', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hermans', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12770']
1068,32560705,The psychometric properties of PHQ-4 anxiety and depression screening scale among out of school adolescent girls and young women in Tanzania: a cross-sectional study.,"BACKGROUND


Literature suggests that most mental disorders have their onset in childhood and adolescence, but go undiagnosed until adulthood. Shorter versions of the screening tools such as the Patient Health Questionnaire with four items (PHQ-4) may help to improve screening coverage. This study assessed the psychometric properties of the PHQ-4 in screening for core symptoms of depression and anxiety among out of school adolescent girls and young women (AGYW).
METHODS


This is a cross-sectional analysis of data from a cluster randomized controlled trial conducted among AGYW between June and July 2018 in North-West Tanzania. Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23 years were included. Data were collected on tablets using audio computer-assisted self-interviews (ACASI). Cronbach's α was used to measure the reliability of the PHQ-4 while confirmatory factor analysis (CFA) and principal components analysis (PCA) were used for construct validity assessment. In CFA, three criteria were used to assess how well the model fits the data: Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA) and 90% confidence interval for RMSEA.
RESULTS


Of the 2426 participants, 33.8 and 35.5% screened positive for core symptoms of anxiety (GAD-2 ≥ 3) and depression (PHQ-2 ≥ 3), respectively. Cronbach's α of the PHQ-4 was 0.81. Both items-correlation and corrected items-correlation of the PHQ-4 had total correlations above 0.5 (p < 0.01). CFA showed that all items loaded significantly onto the single factor, and loadings were strong, ranging from 0.67 to 0.77 (p < 0.01). CFA indicates that the PHQ-4 scale stand for a unidimensional construct with good model fit (CFI = 0.995, SRMR = 0.013, RMSEA = 0.054 and 90% CI for RMSEA (0.031-0.079)). PCA confirmed two distinct components; GAD-2 (anxiety) and PHQ-2 (depression). Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
CONCLUSIONS


The findings suggest that the PHQ-4 scale can reliably and validly screen for core symptoms of depression and anxiety among out of school AGYW. This tool is short and easy to administer. Thus, the PHQ-4 scale can be very useful in screening for anxiety and depression symptoms in the community, primary health facilities, research and programmatic settings.",2020,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
","['school adolescent girls and young women in Tanzania', 'school adolescent girls and young women (AGYW', 'AGYW between June and July 2018 in North-West Tanzania', 'Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23\u2009years were included']",['PHQ-4'],"['CFA', 'GAD-2 (anxiety) and PHQ-2 (depression', 'PHQ-4 anxiety and depression screening scale', 'Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA', 'PHQ-2, GAD-2, and PHQ-4 screening items']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C5197676', 'cui_str': 'GAD-2'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",2426.0,0.0337356,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Materu', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania. jacqueline.materu1989@gmail.com.'}, {'ForeName': 'Evodius', 'Initials': 'E', 'LastName': 'Kuringe', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nyato', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Galishi', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amasha', 'Initials': 'A', 'LastName': 'Mwanamsangu', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maligo', 'Initials': 'M', 'LastName': 'Katebalila', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Shao', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Changalucha', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Soori', 'Initials': 'S', 'LastName': 'Nnko', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Mwita', 'Initials': 'M', 'LastName': 'Wambura', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}]",BMC psychiatry,['10.1186/s12888-020-02735-5']
1069,32560724,"Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study).","BACKGROUND


The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus.
METHODS


In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model.
RESULTS


A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study.
CONCLUSIONS


Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015.",2020,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","['patients with type 2 diabetes mellitus', 'patients with T2DM [glycosylated hemoglobin (HbA1c)\u2009≥\u20097.5%] were enrolled from 39 sites in India', 'patients with type 2 diabetes (T2DM', 'A total of 1155 patients were enrolled in this study', 'T2DM patients']","['pioglitazone', 'saroglitazar or pioglitazone', 'saroglitazar 2\xa0mg and 4\xa0mg', 'saroglitazar']","['FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B', 'cardiovascular risk', 'TG, LDL-C, VLDL-C, TC and Non HDL-C', 'glycemic control, lipid profile and cardiovascular disease risk', 'glycemic control and lipid parameters', 'HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1155.0,0.113944,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Krishnappa', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India. manjunath.k@zyduscadila.com.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Nirali', 'Initials': 'N', 'LastName': 'Mody', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Faldu', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Maroo', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, UAE.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01073-w']
1070,32562650,"Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.","BACKGROUND


Trials of intermittent preventive treatment (IPTp) of malaria in pregnant women that compared dihydroartemisinin-piperaquine with the standard of care, sulfadoxine-pyrimethamine, showed dihydroartemisinin-piperaquine was superior at preventing malaria infection, but not at improving birthweight. We aimed to assess whether sulfadoxine-pyrimethamine shows greater non-malarial benefits for birth outcomes than does dihydroartemisinin-piperaquine, and whether dihydroartemisinin-piperaquine shows greater antimalarial benefits for birth outcomes than does sulfadoxine-pyrimethamine.
METHODS


We defined treatment as random assignment to sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine before pooling individual participant-level data from 1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811). We quantified the relative effect of treatment on birthweight (primary outcome) attributed to preventing placental malaria infection (mediator). We estimated antimalarial (indirect) and non-malarial (direct) effects of IPTp on birth outcomes using causal mediation analyses, accounting for confounders. We used two-stage individual participant data meta-analyses to calculate pooled-effect sizes.
FINDINGS


Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69 g, 95% CI 26 to 112), despite placental malaria infection being lower in the dihydroartemisinin-piperaquine group (relative risk [RR] 0·64, 95% CI 0·39 to 1·04). Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60).
INTERPRETATION


IPTp with sulfadoxine-pyrimethamine appears to have potent non-malarial effects on birthweight. Further research is needed to evaluate monthly dihydroartemisinin-piperaquine with sulfadoxine-pyrimethamine (or another compound with non-malarial effects) to achieve greater protection against malarial and non-malarial causes of low birthweight.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bill & Melinda Gates Foundation, and Worldwide Antimalarial Resistance Network.",2020,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","['pregnant women that compared dihydroartemisinin-piperaquine with the standard of care', '1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811']","['sulfadoxine-pyrimethamine', 'sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine', 'IPTp']","['placental malaria infection (mediator', 'antimalarial effect', 'Overall, birthweight', 'placental malaria infection']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",1617.0,0.206058,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","[{'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rerolle', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'M Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Shiboski', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Ianziva"", 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Chico', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30119-4']
1071,32567339,The Effects of Lipid-Lowering Therapy on Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio: An HIJ-PROPER Sub-Analysis.,"BACKGROUND


Controversy remains regarding the influence of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio.
OBJECTIVE


This study aimed to clarify the effects of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio in patients with acute coronary syndrome (ACS).
METHODS


This was a post hoc sub-analysis of the Heart Institute of Japan-PRoper level of lipid-lowering with pitavastatin and ezetimibe in ACS study. We compared the eicosapentaenoic acid/arachidonic acid ratio changes from baseline to the 3-month follow-up after contemporary lipid-lowering therapy with pitavastatin + ezetimibe therapy and pitavastatin mono-therapy.
RESULTS


Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34,  P  < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27,  P  = .18). When the analysis was limited to patients who received 2 mg/day of pitavastatin during the follow-up period, these trends in changes of the eicosapentaenoic acid/arachidonic acid ratio remained unchanged. Multivariate analysis showed that ezetimibe use ( P  = .005; β = 0.09), ST-elevation myocardial infarction ( P  = .04; β = -0.01), and baseline low-density lipoprotein cholesterol (LDL-C) level ( P  = .0003; β = 0.12) were independent predictors of the percentage change in the eicosapentaenoic acid/arachidonic acid ratio. These trends were similar even when the analysis was limited to patients who did not take statins at enrollment.
CONCLUSION


Standard lipid-lowering therapy with pitavastatin mono-therapy improved the eicosapentaenoic acid/arachidonic acid ratio for patients with ACS. Intensive lipid-lowering therapy with pitavastatin + ezetimibe did not improve the eicosapentaenoic acid/arachidonic acid ratio, although LDL-C decreased significantly. Inhibition of the improvement in the eicosapentaenoic acid/arachidonic acid ratio by adding ezetimibe may affect cardiovascular disease prognosis.",2020,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34,  P  < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27,  P  = .18).","['patients with ACS', 'patients with acute coronary syndrome (ACS']","['pitavastatin', 'eicosapentaenoic acid/arachidonic acid', 'pitavastatin mono-therapy', 'ezetimibe', 'eicosapentaenoic acid/arachidonic acid ratio', 'Lipid-Lowering Therapy', 'lipid-lowering therapy', 'pitavastatin and ezetimibe', 'pitavastatin + ezetimibe therapy and pitavastatin mono-therapy', 'pitavastatin + ezetimibe']","['eicosapentaenoic acid/arachidonic acid', 'baseline low-density lipoprotein cholesterol (LDL-C) level', 'eicosapentaenoic acid/arachidonic acid ratio, although LDL-C', 'eicosapentaenoic acid/arachidonic acid ratio', 'Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio', 'ST-elevation myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]",,0.0782305,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34,  P  < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27,  P  = .18).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420931621']
1072,32568367,"Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial.","Importance


Insulin modulates aspects of brain function relevant to Alzheimer disease and can be delivered to the brain using intranasal devices. To date, the use of intranasal insulin to treat persons with mild cognitive impairment and Alzheimer's disease dementia remains to be examined in a multi-site trial.
Objective


To examine the feasibility, safety, and efficacy of intranasal insulin for the treatment of persons with mild cognitive impairment and Alzheimer disease dementia in a phase 2/3 multisite clinical trial.
Design, Setting, and Participants


A randomized (1:1) double-blind clinical trial was conducted between 2014 and 2018. Participants received 40 IU of insulin or placebo for 12 months during the blinded phase, which was followed by a 6-month open-label extension phase. The clinical trial was conducted at 27 sites of the Alzheimer's Therapeutic Research Institute. A total of 432 adults were screened, and 144 adults were excluded. Inclusion criteria included adults aged 55 to 85 years with a diagnosis of amnestic mild cognitive impairment or Alzheimer disease (based on National Institute on Aging-Alzheimer Association criteria), a score of 20 or higher on the Mini-Mental State Examination, a clinical dementia rating of 0.5 or 1.0, and a delayed logical memory score within a specified range. A total of 289 participants were randomized. Among the first 49 participants, the first device (device 1) used to administer intranasal insulin treatment had inconsistent reliability. A new device (device 2) was used for the remaining 240 participants, who were designated the primary intention-to-treat population. Data were analyzed from August 2018 to March 2019.
Interventions


Participants received 40 IU of insulin (Humulin-RU-100; Lilly) or placebo (diluent) daily for 12 months (blinded phase) followed by a 6-month open-label extension phase. Insulin was administered with 2 intranasal delivery devices.
Main Outcomes and Measures


The primary outcome (mean score change on the Alzheimer Disease Assessment Scale-cognitive subscale 12) was evaluated at 3-month intervals. Secondary clinical outcomes were assessed at 6-month intervals. Cerebrospinal fluid collection and magnetic resonance imaging scans occurred at baseline and 12 months.
Results


A total of 289 participants (155 men [54.6%]; mean [SD] age, 70.9 [7.1] years) were randomized. Of those, 260 participants completed the blinded phase, and 240 participants completed the open-label extension phase. For the first 49 participants, the first device used to administer treatment had inconsistent reliability. A second device was used for the remaining 240 participants (123 men [51.3%]; mean [SD] age, 70.8 [7.1] years), who were designated the primary intention-to-treat population. No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis. No clinically important adverse events were associated with treatment.
Conclusions and Relevance


In this study, no cognitive or functional benefits were observed with intranasal insulin treatment over a 12-month period among the primary intention-to-treat cohort.
Trial Registration


ClinicalTrials.gov Identifier: NCT01767909.",2020,"No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis.","['Mild Cognitive Impairment and Alzheimer Disease Dementia', '289 participants (155 men [54.6%]; mean [SD] age, 70.9 [7.1] years', '289 participants were randomized', 'mean [SD] age, 70.8 [7.1] years), who were designated the primary intention-to-treat population', 'persons with mild cognitive impairment and Alzheimer disease dementia in a phase 2/3 multisite clinical trial', '240 participants (123 men [51.3', ""27 sites of the Alzheimer's Therapeutic Research Institute"", 'Inclusion criteria included adults aged 55 to 85 years with a diagnosis of amnestic mild cognitive impairment or Alzheimer disease (based on National Institute on Aging-Alzheimer Association criteria), a score of 20 or higher on the Mini-Mental State Examination, a clinical dementia rating of 0.5 or 1.0, and a delayed logical memory score within a specified range', '240 participants, who were designated the primary intention-to-treat population', '260 participants completed the blinded phase, and 240 participants completed the open-label extension phase', ""persons with mild cognitive impairment and Alzheimer's disease dementia"", 'A total of 432 adults were screened, and 144 adults were excluded']","['Insulin', 'Intranasal Insulin', '40 IU of insulin (Humulin-RU-100; Lilly) or placebo (diluent', '40 IU of insulin or placebo', 'intranasal insulin']","['Cerebrospinal fluid collection and magnetic resonance imaging scans', 'Safety, Efficacy, and Feasibility', 'Alzheimer Disease Assessment Scale-cognitive subscale 12', 'feasibility, safety, and efficacy']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0282334', 'cui_str': 'Human Experimentation, Therapeutic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1955974', 'cui_str': 'NIA (US)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0020172', 'cui_str': 'Humulin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0394552', 'cui_str': 'Cerebrospinal fluid collection'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}]",289.0,0.580836,"No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine-Geriatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Tiffany W', 'Initials': 'TW', 'LastName': 'Chow', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Rafii', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Chung-Kai', 'Initials': 'CK', 'LastName': 'Sun', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rissman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Brewer', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Jenkins', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Harless', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Gessert', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}]",JAMA neurology,['10.1001/jamaneurol.2020.1840']
1073,32567238,Rationale and design of the AUGUST-AHF Study.,"AIMS


We aim to assess the effect of a lyophilized herbal injection on 90 day mortality and readmission rates in patients with acute heart failure (AHF).
METHODS AND RESULTS


The AUGUST-AHF study is a multicentre, randomized, double-blind, placebo-controlled trial enrolling 1270 hospitalized patients for AHF. Patients are randomized to receive YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, in addition to standard therapy, using a 1:1 ratio via an interactive web response system. The primary endpoint is the 90 day all-cause mortality or AHF readmission rates. Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events. Additional secondary endpoints include change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization. Study recruitment is expected to be completed by March 2021, and follow-up will end in September 2021. In an optional sub-study, patients will be followed up for 3 years.
CONCLUSIONS


To our best knowledge, AUGUST-AHF is the first study assessing the efficacy of a Chinese herbal injection in patients with AHF. The results will be valuable to guide clinicians in using YiqiFumai lyophilized injection, which was included in the latest Chinese Health Insurance Catalog.",2020,"Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events.","['patients with acute heart failure (AHF', 'patients with AHF', '1270 hospitalized patients for AHF']","['lyophilized herbal injection', 'YiqiFumai lyophilized injection', 'Chinese herbal injection', 'placebo']","['change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization', '180\xa0day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90\xa0day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90\xa0day major adverse cardiac events', '90\xa0day all-cause mortality or AHF readmission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3711493', 'cui_str': 'yi-qi-fu-mai'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1270.0,0.263515,"Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events.","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Catholic Health System Internal Medicine Training Program, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}]",ESC heart failure,['10.1002/ehf2.12787']
1074,32574722,HSD3B1 (1245A>C) germline variant and clinical outcomes in metastatic castration-resistant prostate cancer patients treated with abiraterone and enzalutamide: results from two prospective studies.,"BACKGROUND


A common polymorphism (1245A>C) in the HSD3B1 gene is associated with increased de novo synthesis of androgens and worse outcomes in men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer. The objective of the study was to determine whether this polymorphism is associated with outcomes for metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone or enzalutamide.
PATIENTS AND METHODS


A total of 547 patients treated with abiraterone or enzalutamide from two prospective cohorts were evaluated. The HSD3B1 genotype was determined by targeted sequencing and/or TaqMan single-nucleotide polymorphism genotyping. In cohort 1, patients were randomized to receive abiraterone + prednisone or enzalutamide. In cohort 2, patients received either agent according to investigator's choice. Prostate-specific antigen (PSA) response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival were determined. Associations between HSD3B1 genotypes and outcomes were evaluated via univariate Cox regression. Multivariable Cox model was used to determine the independent association of each covariate.
RESULTS


The HSD3B1 variant genotype (CC) was present in 15% of patients and was associated with worse TTP [hazard ratio (HR) 1.31, 95% confidence interval (CI) 1.02-1.67, P = 0.032] and PSA response rates (48% for CC versus 62% and 65% for AA and AC, respectively [P = 0.019]), with no significant difference in TTPP (HR 1.28, 95% CI 0.99-1.66, P = 0.064). The effect of genotype was similar for treatment with abiraterone or enzalutamide with a negative test for interaction for TTPP (P = 0.997) and TTP (P = 0.749). Multivariable analysis did not show a significant association between genotype and TTP or TTPP.
CONCLUSIONS


The HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in patients with mCRPC treated with abiraterone or enzalutamide. However, the CC genotype did not provide prognostic information beyond that conferred by standard clinical variables, suggesting that it may not be a suitable stand-alone biomarker in mCRPC.",2020,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","['metastatic castration-resistant prostate cancer (mCRPC) treated with', 'metastatic castration-resistant prostate cancer patients treated with', 'men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer', '547 patients treated with']","['abiraterone + prednisone or enzalutamide', 'abiraterone and enzalutamide', 'abiraterone or enzalutamide']","['PSA response rate', 'PSA response rates', 'PSA response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival (OS', 'HSD3B1 variant genotype (CC', 'TTPP']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",547.0,0.123766,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Aragón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lozano', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorente', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Hospital General Universitari de Castelló, Castellon, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; BC Cancer Kelowna, Kelowna, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Romero-Laorden', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cendón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer Surrey, Surrey, BC, Canada.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pacheco', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer Abbotsford, Abbotsford, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada; Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castro', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain; Medical Oncology Department, Hospital Universitario Virgen de la Victoria y Regional de Málaga, Malaga, Spain. Electronic address: elena.castro@ibima.eu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.006']
1075,32579674,Kin recognition and perceived facial similarity.,"Facial similarity between individuals informs kinship judgments in third-party kin recognition. Indeed, one study found that similarity and kinship judgments encapsulate the same information (Maloney & Dal Martello, 2006). Yet, another study found that this is not the case when comparing adult face pairs of different sex (DeBruine et al., 2009). We replicated these studies to further clarify the role of facial similarity in kin recognition. We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old. Each rater was randomly assigned to make either kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar]). The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task. In both tasks, opposite-sex siblings were perceived to be siblings less often than same-sex siblings, and judgments of unrelated face pairs were not affected by the sex of faces. Conversely, the effect of age difference within pairs of faces differed for the two tasks: a greater age difference decreased all kinship judgments, but only decreased similarity judgments of siblings, not unrelated pairs. In line with DeBruine et al. (2009), these findings suggest that similarity and kinship judgments are highly correlated but not strictly synonymous. The OSF Pre-registration Challenge for this project can be found at osf.io/ps9hy and the data at osf.io/sef9k.",2020,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","['We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old']","['kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar']","['Kin recognition and perceived facial similarity', 'Facial similarity']","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",,0.0189401,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hansen', 'Affiliation': ',.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'DeBruine', 'Affiliation': '.'}, {'ForeName': 'Iris J', 'Initials': 'IJ', 'LastName': 'Holzleitner', 'Affiliation': '.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': '.'}, {'ForeName': 'Kieran J', 'Initials': 'KJ', 'LastName': ""O'Shea"", 'Affiliation': '.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Fasolt', 'Affiliation': '.'}]",Journal of vision,['10.1167/jov.20.6.18']
1076,32584168,"The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial.","Rationale:  In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives:  To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods:  Exacerbations and change from baseline in trough FEV 1  and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results:  FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction;  P  < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction;  P  = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%;  P  < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction;  P  < 0.001; non-ICS users, 35% reduction;  P  = 0.018), and overall when excluding the first 30 days (29%;  P  < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV 1  and St. George's Respiratory Questionnaire, regardless of prior ICS use. Conclusions:  These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, Research and Development, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC']
1077,32578353,Rationale and design of the EMPYREAN study.,"AIMS


A sodium glucose cotransporter 2 (SGLT2) inhibitor was recently found to reduce heart failure hospitalization in the EMPA-REG OUTCOME trial. We have hypothesized that autonomic nerve activity may be modulated by SGLT2 inhibition. The current study aims to investigate the impact of empagliflozin on sympathetic and parasympathetic nerve activity in patients with type 2 diabetes mellitus.
METHODS AND RESULTS


This ongoing study is a prospective, randomized, open-label, multicentre investigation of 134 patients with type 2 diabetes mellitus. The patients are randomly allocated to receive either empagliflozin or sitagliptin with the treatment goal of the Japan Diabetes Society guidelines. Ambulatory electrocardiographic monitoring is performed at the baseline and at 12 and 24 weeks of treatment. Analyses of heart rate variability are conducted using the MemCalc method, which is a combination of the maximum entropy method for spectral analysis and the non-linear least squares method for square analysis. The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks.
CONCLUSIONS


This investigation on the effect of EMPagliflozin on cardiac sYmpathetic and parasympathetic neRve activity in JapanEse pAtieNts with type 2 diabetes (EMPYREAN study) offers an important opportunity to understand the impact of SGLT2 inhibition on autonomic nerve activity in patients with type 2 diabetes.",2020,"The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks.
","['JapanEse pAtieNts with type 2 diabetes', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes', '134 patients with type 2 diabetes mellitus']","['sodium glucose cotransporter 2', 'empagliflozin', 'empagliflozin or sitagliptin', 'EMPagliflozin', 'SGLT2 inhibition']","['cardiac sYmpathetic and parasympathetic neRve activity', 'heart failure hospitalization', 'change in the low-frequency']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",134.0,0.044986,"The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks.
","[{'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Motoki', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yasuno', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shoin', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Department of Internal Medicine, Taigenkai Hospital, Ichinomiya, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Mitsuhisa', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Son', 'Affiliation': 'Division of Endocrinology and Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Yonemitsu', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hiramitsu', 'Affiliation': 'Hiramitsu Heart Clinic, Nagoya, Japan.'}, {'ForeName': 'Manako', 'Initials': 'M', 'LastName': 'Konda', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Onishi', 'Affiliation': 'Onishi Heart Clinic, Tsu, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kuwahara', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}]",ESC heart failure,['10.1002/ehf2.12825']
1078,32444296,Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.,"OBJECTIVES


We aimed to evaluate the efficacy of intracutaneous sterile water injection (ISWI) to relieve the pain of acute renal colic compared with diclofenac and placebo.
METHODS


The study included 150 patients presented to the Emergency Department with renal colic randomized into 3 groups: control group received intracutaneous injections of 0.5 cm 3  isotonic saline in the flank, group A received intracutaneous injections of 0.5 cm 3  ISWI in the flank, and group B received an intramuscular injection of 75 mg Diclofenac in the gluteal region. The severity of the pain was assessed by a visual analogue scale system at baseline and 30, 45 min, and 60 min after injections. Subjects with inadequate pain relief at 1 h received rescue analgesia.
RESULTS


The mean baseline pain score was 9.6 ± 0.61 in the ISWI group, 9.72 ± 0.64 in the diclofenac group and 9.26 ± 0.89 in the control group. The mean pain score at 30 min of the control group was reduced to 6.9 ± 1.56. This mean at 30 min after ISWI and diclofenac injections were reduced to 1.98 ± 1.41 and 1.88 ± 1.19 respectively. The mean of pain sore of the ISWI and diclofenac group at 45 and 60 min was constant. Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
CONCLUSIONS


ISWI and diclofenac were equally effective for the pain relief of acute renal colic.",2020,"Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
","['acute renal colic pain', 'Subjects with inadequate pain relief at 1\xa0h received rescue analgesia', '150 patients presented to the Emergency Department with renal colic randomized into 3 groups']","['Intradermal sterile water injection versus diclofenac sodium', 'control group received intracutaneous injections of 0.5\xa0cm 3  isotonic saline in the flank, group A received intracutaneous injections of 0.5\xa0cm 3  ISWI in the flank, and group B received an intramuscular injection of 75\xa0mg Diclofenac', 'diclofenac injection respectively', 'intracutaneous sterile water injection (ISWI', 'diclofenac', 'diclofenac and placebo', 'ISWI and diclofenac']","['mean of pain sore', 'severity of the pain', 'visual analogue scale system', 'pain relief of acute renal colic', 'mean pain score', 'mean baseline pain score', 'Rescue analgesics']","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1708484', 'cui_str': 'Inadequate pain relief'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C4291486', 'cui_str': 'Diclofenac Injection [Dyloject]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",150.0,0.0931731,"Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'Head of Urology Department, Zahraa Hospital, University Medical Center, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Athanasios G', 'Initials': 'AG', 'LastName': 'Papatsoris', 'Affiliation': '2nd Department of Urology, School of Medicine, Sismanoglio Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Mohamed Abou', 'Initials': 'MA', 'LastName': 'Chakra', 'Affiliation': 'Faculty of Medical Sciences, Department of Urology, Lebanese University, Beirut, Lebanon. Electronic address: mohamedabouchakra@hotmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.04.079']
1079,32449277,Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation.,"BACKGROUND


Constipated patients remain dissatisfied with current treatments suggesting a need for alternative therapies.
AIM


Evaluate the mechanistic effects of oral vibrating capsule in chronic idiopathic constipation (CIC) by examining the temporal relationships between the onset of vibrations, complete spontaneous bowel movements (CSBM), and circadian rhythm.
METHODS


In post hoc analyses of two double-blind studies, CIC patients (Rome III) were randomized to receive 5 active or sham capsules/week for 8 weeks. The capsules were programmed for single vibration (study 1) or two vibration sessions with two modes, 8 hours apart (study 2). Daily electronic diaries assessed stool habit and percentage of CSBMs associated with vibrations. Responders were patients with ≥ 1 CSBM per week over baseline.
RESULTS


250 patients were enrolled (active = 133, sham = 117). During and within 3 hours of vibration, there were significantly more % CSBMs in the active vs. sham group (50% vs. 42%; P = .0018). In study 2, there were two CSBM peaks associated with vibration sessions. Significantly more % CSBMs occurred in active mode 1 (21.5%) vs. sham (11.5%); (P = .0357). Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75). Device was well-tolerated barring mild vibration sensation.
CONCLUSIONS


Vibrating capsule may increase CSBMs possibly by enhancing the physiologic effects of waking and meals, and augmenting circadian rhythm, although responder rate was not different from sham. Two vibration sessions were associated with more CSBMs.",2020,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","['250 patients were enrolled (active\xa0=\xa0133, sham\xa0=\xa0117', 'CIC patients (Rome III', 'chronic idiopathic constipation', 'chronic idiopathic constipation (CIC']","['oral vibrating capsule', 'vibrating capsule']","['Responder rates', 'CSBMs', 'Daily electronic diaries assessed stool habit and percentage of CSBMs', 'colonic circadian rhythm and bowel symptoms']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",250.0,0.356394,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Augusta University Medical Center, Augusta, GA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Friedenberg', 'Affiliation': 'Great Lakes Gastroenterology Research, Mentor, OH, USA.'}, {'ForeName': 'Eamonn M M', 'Initials': 'EMM', 'LastName': 'Quigley', 'Affiliation': 'Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital, Weill Cornell Medical College, Houston, TX, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13890']
1080,32575611,"Effect of a Flaxseed Lignan Intervention on Circulating Bile Acids in a Placebo-Controlled Randomized, Crossover Trial.","Plant lignans and their microbial metabolites, e.g., enterolactone (ENL), may affect bile acid (BA) metabolism through interaction with hepatic receptors. We evaluated the effects of a flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside) compared to a placebo for 60 days each on plasma BA concentrations in 46 healthy men and women (20-45 years) using samples from a completed randomized, crossover intervention. Twenty BA species were measured in fasting plasma using LC-MS. ENL was measured in 24-h urines by GC-MS. We tested for (a) effects of the intervention on BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL. We also explored the overlap in bacterial metabolism at the genus level and conducted in vitro anaerobic incubations of stool with lignan substrate to identify genes that are enriched in response to lignan metabolism. There were no intervention effects, overall or stratified by ENL at FDR < 0.05. In the cross-sectional analysis, irrespective of treatment, five secondary BAs were associated with ENL excretion (FDR < 0.05). In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases. These data suggest overlap in community bacterial metabolism of secondary BA and ENL.",2020,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,['46 healthy men and women (20-45 years) using samples'],"['flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside', 'Flaxseed Lignan Intervention', 'placebo']","['fasting plasma using LC-MS', 'Circulating Bile Acids', 'BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL', 'plasma BA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0045341', 'cui_str': ""2,3-bis(3'-hydroxybenzyl)butyrolactone""}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",46.0,0.0675738,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,"[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Curtis', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Elkon', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Orsalem J', 'Initials': 'OJ', 'LastName': 'Kahsai', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Hamza S', 'Initials': 'HS', 'LastName': 'Ammar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Natalie N', 'Initials': 'NN', 'LastName': 'Hong', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Carnevale Neto', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Chapkin', 'Affiliation': 'Program in Integrative Nutrition & Complex Diseases, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}]",Nutrients,['10.3390/nu12061837']
1081,32442189,Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.,"BACKGROUND


Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa.
METHODS AND FINDINGS


In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection.
CONCLUSIONS


In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721798.",2020,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","['women living with HIV in South Africa', 'Participant median age was 31 years, and 95% had 1 or more prior pregnancies', 'male partners', 'We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women', 'Cape Town, South Africa', 'eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART', 'Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent', 'Women living with HIV (WLHIV']","['Hormonal contraceptives', 'levonorgestrel intrauterine system', 'injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC', 'levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD']","['39 serious adverse events (SAEs); SAEs', 'gVL or pVL and had low levels of contraceptive failure and associated PID', 'Mean hemoglobin change', 'elective discontinuation', 'hemoglobin levels', 'pVL, RTI, and pregnancy testing', 'genital tract HIV viral load (gVL) and sexual transmission risk', 'mean pVL', 'gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation', 'expulsion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009866', 'cui_str': 'Contraception failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031406', 'cui_str': 'Phenindione'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]",71.0,0.642316,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Todd', 'Affiliation': 'Maternal and Child Health and Nutrition Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, City University of New York School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Nontokozo', 'Initials': 'N', 'LastName': 'Langwenya', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Institute for Health Care Policy and Aging Research, Rutgers University, Piscataway, New Jersey, United States of America.'}, {'ForeName': 'Pai-Lien', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Global Population and Health Research Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Petro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003110']
1082,32453383,Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial.,"Importance


Strategies to reduce the inappropriate prescription of antipsychotics have been the focus of recent attention but have shown considerable variation in their effectiveness.
Objective


To evaluate the effectiveness of academic detailing in nursing homes targeting appropriate prescribing of antipsychotics.
Design, Setting, and Participants


We conducted a pragmatic, cluster randomized clinical trial comparing the effect of academic detailing vs usual care on prescribing antipsychotics in 40 nursing homes with 5363 residents in Ontario, Canada. Data were collected from October 2015 to March 2016 and analyzed from April to August 2018. Primary analyses were conducted using intention to treat.
Intervention


Academic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits). Academic detailers had direct and ongoing contact with the nursing homes from the time of launch.
Main Outcomes and Measures


The primary outcome, defined at the level of the resident, was whether continuous antipsychotics were dispensed in the past week. Secondary outcomes included prescribing of other psychotropic medications and clinical outcomes and scores. Prescribing outcomes were assessed at baseline and at 3, 6, and 12 months, and clinical outcomes and scores were assessed at baseline and 3 and 6 months.
Results


A total of 40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents). Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men). At 12 months, there was no statistically significant difference in the frequency of daily antipsychotic use (intervention: 569 patients [25.2%]; control: 769 [25.6%]; odds ratio, 1.06; 95% CI, 0.93-1.20; P = .49). There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
Conclusions and Relevance


The intervention did not further reduce antipsychotic prescribing in nursing homes beyond system-level secular trends occurring alongside usual care. Our findings highlight the need for a more targeted approach to quality improvement strategies, including academic detailing, that account for the timing and topic of interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02604056.",2020,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","['Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men', '40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents', 'Data were collected from October 2015 to March 2016 and analyzed from April to August 2018', 'Nursing Homes', '40 nursing homes with 5363 residents in Ontario, Canada']","['academic detailing vs usual care on prescribing antipsychotics', 'Antipsychotic Medication', 'Academic Detailing', 'Intervention\n\n\nAcademic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits']","['depression (mean [SD] Depression Rating Scale score', 'prescribing of other psychotropic medications and clinical outcomes and scores', 'frequency of daily antipsychotic use', 'pain', 'rates of health care utilization']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",5363.0,0.142155,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Tadrous', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Kinwah', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Women's College Research Institute, Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gomes', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'University of Ottawa School of Epidemiology, Public Health and Preventive Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5724']
1083,32451321,Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE-ABSORB randomised clinical trial.,"AIMS


The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS).
METHODS AND RESULTS


The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group.
CONCLUSIONS


In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.",2020,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","['1,670 patients were recruited (BVS 848 patients and EES 822 patients', 'Patients at High Risk of Restenosis', 'patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS', 'Patients at high risk of restenosis']","['Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent', 'BVS or everolimus-eluting stent (EES']","['target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization', 'TLF', 'TVMI', 'thrombosis and TVMI rate', 'Definite or probable device thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",1670.0,0.283667,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","[{'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': ''}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kocka', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Robert-Jan M', 'Initials': 'RM', 'LastName': 'van Geuns', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01079']
1084,32452561,Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding.,"BACKGROUND


Early-transjugular intrahepatic porto-systemic shunt (TIPSS) has been recommended in international guidelines for high-risk patients with oesophageal variceal bleeding.
AIM


To validate the results of a previous randomised control trial which supports use of early-TIPSS.
METHODS


In a two-centre open-label parallel-group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso-active drugs and endoscopic band ligation. Participants were randomised to standard of care or early-TIPSS. The primary outcome was 1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension.
RESULTS


Fifty-eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early-TIPSS group, a 1-year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early-TIPSS group (P = 0.09). Not all participants randomised to early-TIPSS received the intervention in time. For those receiving TIPSS per-protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
CONCLUSIONS


Early-TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high-risk patients with oesophageal variceal bleeding. Early-TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.",2020,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","['high-risk patients with oesophageal variceal bleeding', 'Fifty-eight patients (58\xa0±\xa011.12\xa0years; 32.7% female', 'patients with cirrhosis and acute variceal bleeding were recruited following', 'patients with cirrhosis and oesophageal variceal bleeding']","['transjugular intrahepatic porto-systemic shunt (TIPSS', 'standard of care or early-TIPSS', 'care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS', 'haemostasis with vaso-active drugs and endoscopic band ligation']","['Variceal rebleeding', 'rates of hepatic encephalopathy', 'Serious adverse events', 'survival', 'variceal rebleeding, increased encephalopathy', 'variceal rebleeding rates', '1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension', '1-year survival']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]",58.0,0.414712,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","[{'ForeName': 'Philip D J', 'Initials': 'PDJ', 'LastName': 'Dunne', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Ireland', 'Affiliation': 'Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15797']
1085,32443142,The Long-term Effectiveness of the Automatic Position-Adaptive System in Spinal Cord Stimulation: A Retrospective Comparative Study with a Two-Year Follow-up.,"OBJECTIVE


To compare the nonadaptive manual system with the position-adaptive system in subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period.
DESIGN


Retrospective study.
SETTING


Tertiary university-based national hospital.
SUBJECTS


Patients who underwent permanent SCS implantation procedures.
METHODS


Patients were divided into an adaptive group and a nonadaptive group according to the type of implanted SCS device. The primary outcome was the change (%) in pain intensity from baseline between the adaptive and nonadaptive groups at 24 months after SCS implantation. The secondary outcomes were comparisons of detailed clinical variables such as the scores of patient pain and satisfaction during the two-year follow-up after SCS therapy. Further, the number of subjects with SCS removal or revision within two years after SCS implantation was investigated.
RESULTS


Of 187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed. The reduction in pain intensity at 24 months was higher in the adaptive group (-38.6%) than in the nonadaptive group (-30.8%, P = 0.05). Similarly, patient satisfaction with the SCS treatment at 24 months was superior in the adaptive group than in the nonadaptive group (85.7% vs 67.5% were satisfied in each group, respectively, P = 0.024). During the two years, 5.3% of patients (N = 10) underwent SCS removal and 7.0% (N = 13) underwent revision procedures.
CONCLUSIONS


There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.",2020,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","['Tertiary university-based national hospital', 'Patients', '187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed', 'subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period', 'Patients who underwent permanent SCS implantation procedures', 'Spinal Cord Stimulation']","['Automatic Position-Adaptive System', 'nonadaptive group according to the type of implanted SCS device']","['change (%) in pain intensity', 'pain intensity', 'patient satisfaction', 'scores of patient pain and satisfaction']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449497', 'cui_str': 'Type of device'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",187.0,0.0470401,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","[{'ForeName': 'Eun Kyoung', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Soon', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yongjae', 'Initials': 'Y', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngwon', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jee Youn', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa121']
1086,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND


Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS


Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS


For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS


While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
1087,32446470,"Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.","OBJECTIVE


To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.
STUDY DESIGN


Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.
RESULTS


In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.
CONCLUSIONS


Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03294473 and NCT03246100.",2020,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","['Influenza Vaccinations', '61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices', 'October 2017 to April 1, 2018, in New York State and Colorado']","['centralized reminder/recall (autodialer, text, mailed reminders', 'centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control']","['postintervention influenza vaccination rates', 'receipt of ≥1 influenza vaccine']","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",61931.0,0.279722,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA. Electronic address: pszilagyi@mednet.ucla.edu.""}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, CO.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.020']
1088,32446674,Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey.,"STUDY OBJECTIVE


It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
METHODS


A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ 2 , and Fisher's exact tests were conducted.
RESULTS


Of 317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
CONCLUSION


This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.",2020,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","['participants at all sites in a large, multicenter exception from informed consent trial', 'Twenty-seven percent disagreed with enrollment in the study without prospective consent', '317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed', 'Black participants', 'pediatric and adult patients']",['benzodiazepine-refractory status epilepticus'],"['attitudes toward trial enrollment, exception from informed consent, and community consultation']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",317.0,0.0303521,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","[{'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Scicluna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI. Electronic address: vmah@med.umich.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Biros', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Deneil K', 'Initials': 'DK', 'LastName': 'Harney', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Jones', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Mitchell', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Pentz', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'Speight', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Neal W', 'Initials': 'NW', 'LastName': 'Dickert', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Emory University Rollins School of Public Health, Atlanta, GA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.03.017']
1089,32453406,Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial.,"Importance


Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.
Objective


To compare 3 treatment strategies for MOH.
Design, Setting, and Participants


This open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.
Interventions


Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal.
Main Outcomes and Measures


The primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH.
Results


Of 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).
Conclusion and Relevance


All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.
Trial Registration


ClinicalTrials.gov Identifier: NCT02993289.",2020,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","['120 patients, 102 (mean [SD] age', '43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up', 'Medication Overuse Headache', 'tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019', '483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding', '75 refused participation and 120 were included']","['withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal']","['chance of MOH cure', 'reduction of migraine days per month, use of short-term medication, or headache intensity', 'Headache days per month', 'change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH', 'episodic headache', 'change in headache days', 'cured of MOH']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0039567', 'cui_str': 'Tertiary Sector'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",483.0,0.1209,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","[{'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Currently a PhD student at the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Maria Lurenda', 'Initials': 'ML', 'LastName': 'Westergaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1179']
1090,32452275,A Novel Wearable Device for Motor Recovery of Hand Function in Chronic Stroke Survivors.,"Background.  In monkey, reticulospinal connections to hand and forearm muscles are spontaneously strengthened following corticospinal lesions, likely contributing to recovery of function. In healthy humans, pairing auditory clicks with electrical stimulation of a muscle induces plastic changes in motor pathways (probably including the reticulospinal tract), with features reminiscent of spike-timing dependent plasticity. In this study, we tested whether pairing clicks with muscle stimulation could improve hand function in chronic stroke survivors.  Methods.  Clicks were delivered via a miniature earpiece; transcutaneous electrical stimuli at motor threshold targeted forearm extensor muscles. A wearable electronic device (WD) allowed patients to receive stimulation at home while performing normal daily activities. A total of 95 patients >6 months poststroke were randomized to 3 groups: WD with shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care. Those allocated to the device used it for at least 4 h/d, every day for 4 weeks. Upper-limb function was assessed at baseline and weeks 2, 4, and 8 using the Action Research Arm Test (ARAT), which has 4 subdomains (Grasp, Grip, Pinch, and Gross).  Results.  Severity across the 3 groups was comparable at baseline. Only the paired stimulation group showed significant improvement in total ARAT (median baseline: 7.5; week 8: 11.5;  P  = .019) and the Grasp subscore (median baseline: 1; week 8: 4;  P  = .004).  Conclusion.  A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.",2020,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"['chronic stroke survivors', '95 patients >6 months poststroke', 'Chronic Stroke Survivors']","['pairing clicks with muscle stimulation', 'shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care']","['Upper-limb function', 'Grasp subscore', 'upper-limb function', 'total ARAT']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",95.0,0.0695364,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"[{'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shobhana', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Dwaipayan', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Sidharth Shankar', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Shubham', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Gangopadhyay', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Stuart N', 'Initials': 'SN', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320926162']
1091,32457427,Early cessation of a randomised study in acute graft versus host disease: upfront mesenchymal stromal cells with corticosteroids versus corticosteroids alone.,,2020,,[],['corticosteroids versus corticosteroids alone'],[],[],"[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0355741,,"[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Purtill', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia. Duncan.purtill@health.wa.gov.au.'}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Cirillo', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Fogarty', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Cooney', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cannell', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Herrmann', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Sturm', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}]",Bone marrow transplantation,['10.1038/s41409-020-0955-9']
1092,32453368,Effect of Antihypertensive Medication Reduction vs Usual Care on Short-term Blood Pressure Control in Patients With Hypertension Aged 80 Years and Older: The OPTIMISE Randomized Clinical Trial.,"Importance


Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.
Objective


This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.
Design, Setting, and Participants


The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.
Interventions


Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.
Main Outcomes and Measures


The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.
Results


Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
Conclusions and Relevance


Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.
Trial Registration


EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221.",2020,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","['older patients with hypertension', 'Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included', 'older patients with polypharmacy and multimorbidity', 'Patients With Hypertension Aged 80 Years and Older', '569 patients randomized (mean age, 84.8 years; 276 [48.5%] women', '69 primary care sites in England', 'older patients treated with multiple antihypertensive medications', 'Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019']","['antihypertensive medication reduction (removal of 1 drug [intervention], n\u2009=\u2009282) or usual care (control, n\u2009=\u2009287), in which no medication changes were mandated', 'Antihypertensive Medication Reduction vs Usual Care', 'antihypertensive medications']","['Medication reduction', 'serious adverse event', 'systolic blood pressure control or adverse events', 'systolic blood pressure', 'proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events', 'Mild Systolic Hypertension']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension'}]",569.0,0.108474,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Sheppard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Burt', 'Affiliation': 'The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Temple', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rosalyn', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Shahela', 'Initials': 'S', 'LastName': 'Kodabuckus', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Population Sciences and Medical Education Unit, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rupert A', 'Initials': 'RA', 'LastName': 'Payne', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Marney', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Patient and public involvement representative, London, United Kingdom.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.4871']
1093,32452085,Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): results in the pre-specified subgroup with heart failure.,"AIMS


The AMBER trial demonstrated that concomitant use of patiromer enabled the more persistent use of spironolactone by reducing the risk of hyperkalaemia in patients with resistant hypertension and advanced chronic kidney disease. We report herein the pre-specified subgroup analysis in patients with heart failure (HF).
METHODS AND RESULTS


Participants were randomly assigned (1:1) to receive either placebo or patiromer (8.4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Dose titrations were permitted after 1 week for patiromer/placebo and after 3 weeks for spironolactone. The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomized patients (intention to treat). A total of 295 patients were enrolled, of whom 132 (45%) had HF. In the HF subgroup, 68.1% of patients receiving placebo remained on spironolactone at week 12, compared with 84.1% of patients receiving patiromer (P = 0.0504). The reason for discontinuation from spironolactone use was hyperkalaemia in the majority of both groups. There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
CONCLUSIONS


Consistent with the overall AMBER trial results, this pre-specified subgroup analysis in patients with HF, resistant hypertension and advanced chronic kidney disease demonstrated that patiromer enabled more persistent use of spironolactone by reducing the risk of hyperkalaemia.",2020,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","['patients with resistant hypertension and chronic kidney disease', 'Participants', 'A total of 295 patients were enrolled, of whom 132 (45%) had HF', 'patients with resistant hypertension and advanced chronic kidney disease', 'patients with heart failure (HF']","['placebo or patiromer (8.4\xa0g once daily), in addition to open-label spironolactone', 'spironolactone', 'placebo']","['Efficacy endpoints and safety', 'risk of hyperkalaemia', 'AMBER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0242864', 'cui_str': 'Amber'}]",295.0,0.129969,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Science University College London (UCL) and National Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Martha R', 'Initials': 'MR', 'LastName': 'Mayo', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Arthur', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackourey', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1860']
1094,32452128,Spironolactone dose in heart failure with preserved ejection fraction: findings from TOPCAT.,"AIMS


Spironolactone up-titration may be limited by side effects that could be minimized at lower than target doses, but whether lower than target doses remain efficacious is unknown. In TOPCAT, spironolactone (or placebo) were started at 15 mg/day, and increased up to a maximum of 45 mg/day. The prognostic implications related to spironolactone dose are yet to be reported. We aimed to assess the average spironolactone/placebo doses provided during the trial, overall and within high-risk subgroups (e.g. elderly, renal dysfunction, high potassium); discontinuation rates; and the efficacy of lower than target doses in heart failure with preserved ejection fraction.
METHODS AND RESULTS


Overall, 1767 patients from 'TOPCAT-Americas' were included. Linear, logistic and Cox regressions were applied. Patients randomized to spironolactone received lower doses than placebo: 22.5 (15.0-27.5) mg/day vs. 27.5 (17.5-27.5) mg/day (P < 0.001). Patients aged ≥75 years, with an estimated glomerular filtration rate ≤60 mL/min/1.73 m 2  , and with potassium levels >4.5 mmol/L, received lower spironolactone doses (median ≈ 20 mg/day). This pattern of dose differences was not observed in patients taking placebo, where the between-subgroup placebo doses were similar (spironolactone-placebo by subgroup P interaction   < 0.05). Among patients taking spironolactone, 25.4% discontinued the drug during the first year, compared with 18.3% of the patients taking placebo (P < 0.001). Discontinuation rates in the aforementioned high-risk subgroups reached 30% during the first year. Spironolactone reduced the primary outcome of heart failure hospitalization/cardiovascular death without significant heterogeneity between the study subgroups (P interaction   > 0.1). Spironolactone discontinuation was associated with a two to fourfold higher risk of subsequent events.
CONCLUSION


Spironolactone (but not placebo) was used at lower doses among the elderly, those with renal dysfunction and with higher potassium levels. The effect of spironolactone was homogeneous across these subgroups. In patients unable to tolerate target doses, a low-dose strategy should be preferred to stopping treatment.",2020,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"['1767 patients from ""TOPCAT-Americas"" were included', 'Patients', 'Heart Failure with Preserved Ejection Fraction']","['spironolactone', 'Spironolactone', 'spironolactone-placebo', 'spironolactone/placebo', 'TOPCAT, spironolactone (or placebo', 'placebo']","['discontinuation rates', 'HFH/CVD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1767.0,0.207414,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.1909']
1095,32459348,Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.,"Importance


Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden.
Objective


To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain.
Design, Setting, and Participants


Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019.
Interventions


The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual.
Main Outcomes and Measures


Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments.
Results


A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44).
Conclusions and Relevance


Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible.
Trial Registration


German Clinical Trials Register Identifier: DRKS00007960.",2020,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","['Patients With Persistent Back Pain', 'patients with persistent back pain', '295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4', 'Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017', 'Back Pain Patients (PROD-BP']","['web-based self-help intervention', 'e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy', 'Guided Web-Based Self-help Intervention']","['time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5', 'incidence of major depressive episode (MDE', 'MDE', 'risk of MDE onset', 'depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",295.0,0.196853,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","[{'ForeName': 'Lasse B', 'Initials': 'LB', 'LastName': 'Sander', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Paganini', 'Affiliation': 'Institute for Sports and Sport Science, Department of Sports Psychology, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Institute of Psychology and Education, Department of Research Methods, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Medical Center, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Spanhel', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Institute of Psychology and Education, Department of Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1021']
1096,32459597,Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer.,"PURPOSE


Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC.
METHODS


Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13.
RESULTS


Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5%  v  8.2%; ABCP, 48.6%  v  21.2%; BCP, 44.7%  v  11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly.
CONCLUSION


ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.",2020,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","['Non-Small-Cell Lung Cancer', 'chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC', 'Patients']","['Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy', 'Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP', 'atezolizumab to chemotherapy with and without bevacizumab', 'ABCP', 'bevacizumab, carboplatin, and paclitaxel (BCP', 'atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP']","['incidence of serious AEs (SAEs', 'Completion rates of the PRO questionnaires', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13', 'global health status or physical functioning scores', 'incidence, nature, and severity of adverse events (AEs', 'overall survival and investigator-assessed progression-free survival', 'Treatment tolerability']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.253518,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Evangelisches Krankenhaus Hamm gGmbH, Hamm, Germany.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Orlandi', 'Affiliation': 'Instituto Nacional del Tórax, Santiago, Chile.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer & Research Center, Chandler, AZ.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'González Larriba', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rothenstein', 'Affiliation': 'Durham Regional Cancer Center, Lakeridge Health, Oshawa, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Cantonal Hospital of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Shankar', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kelsch', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03158']
1097,32460179,Preclinical profile and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-resistant prostate cancer.,"PURPOSE


We conducted preclinical experiments and phase I clinical trial to investigate the safety, pharmacokinetics (PK) and antitumour effects of GT0918 in castration-resistant prostate cancer (CRPC).
EXPERIMENTAL DESIGN


An androgen receptor (AR) competitive binding assay was performed, followed by evaluation of GT0918 on AR protein expression. The efficacy of GT0918 was investigated in a castration-resistant xenograft model. A phase I dose-escalation study of GT0918 in CRPC was also carried out to evaluate its safety, PK and antitumour efficacy.
RESULTS


GT0918 was demonstrated to inhibit the binding of androgen to AR more potently than MDV3100, and to effectively reduce the AR protein level. GT0918 inhibited the transcriptional activity of wild-type AR and AR with clinically relevant ligand-binding domain mutations. Furthermore, GT0918 significantly inhibited the growth of prostate cancer. A total of 16 patients was treated with GT0918 at five dose levels. Among these 16 patients, 10 and 2 patients, respectively, completed a three-cycle and six-cycle treatment, in which MTD was not reached. All the treatment-related adverse events were grade I, including hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia. PK parameters showed that drug exposure increased with dose proportionally from 50 to 300 mg and a saturation was observed between 300 and 400 mg. PSA declines of ≥30% and ≥50% were, respectively, observed in six and two cases. All the 12 patients with metastatic soft tissue lesions confirmed stable disease.
CONCLUSIONS


GT0918, a full AR antagonist without agonist effect, has high binding affinity to AR with AR protein down-regulation activity. GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC. CLINICALTRIALS: gov identifier CTR20150501.",2020,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"['castration-resistant prostate cancer (CRPC', 'castration-resistant prostate cancer', '12 patients with metastatic soft tissue lesions confirmed stable disease']",['novel androgen receptor antagonist GT0918'],"['safety, pharmacokinetics (PK) and antitumour effects', 'growth of prostate cancer', 'PSA declines', 'AR protein level', 'safety, PK\xa0and antitumour efficacy', 'transcriptional activity of wild-type AR and AR', 'hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia']","[{'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}, {'cui': 'C4043276', 'cui_str': 'GT0918'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",16.0,0.014045,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"[{'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fubo', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qianxiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Chunyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China. Electronic address: cychen@kintor.com.cn.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: sunyhsmmu@126.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.013']
1098,32461104,Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo.,"BACKGROUND


The predictive value of tumor mutational burden (TMB), alone or in combination with an immune gene expression profile (GEP), for response to neoadjuvant therapy in early triple negative breast cancer (TNBC) is currently not known, either for immune checkpoint blockade (ICB) or conventional chemotherapy.
PATIENTS AND METHODS


We obtained both whole exome sequencing and RNA-Seq data from pretreatment samples of 149 TNBC of the recent neoadjuvant ICB trial, GeparNuevo. In a predefined analysis, we assessed the predictive value of TMB and a previously developed immune GEP for pathological complete remission (pCR).
RESULTS


Median TMB was 1.52 mut/Mb (range 0.02-7.65) and was significantly higher in patients with pCR (median 1.87 versus 1.39; P = 0.005). In multivariate analysis, odds ratios for pCR per mut/Mb were 2.06 [95% confidence intervals (CI) 1.33-3.20, P = 0.001] among all patients, 1.77 (95% CI 1.00-3.13, P = 0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P = 0.016) in the placebo treatment arm, respectively. We also found that both continuous TMB and immune GEP (or tumor infiltrating lymphocytes) independently predicted pCR. When we stratified patients in groups based on the upper tertile of TMB and median GEP, we observed a pCR rate of 82% (95% CI 60% to 95%) in the group with both high TMB and GEP in contrast to only 28% (95% CI 16% to 43%) in the group with both low TMB and GEP.
CONCLUSIONS


TMB and immune GEP add independent value for pCR prediction. Our results recommend further analysis of TMB in combination with immune parameters to individually tailor therapies in breast cancer.",2020,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.",['early triple negative breast cancer (TNBC'],[],"['pCR rate', 'Median TMB']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",[],"[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.160939,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany. Electronic address: t.karn@em.uni-frankfurt.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Holtrich', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jank', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital, Ulm, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital, Kiel, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Hospital, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital, Aachen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Comprehensive Cancer Center, Friedrich-Alexander University, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center of Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.015']
1099,32467417,"A nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury: A randomised, placebo-controlled pilot study.","BACKGROUND


Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α.
OBJECTIVE


The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy.
DESIGN


Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study.
SETTING


Eight secondary care centres, the United Kingdom between April 2015 and June 2017.
PATIENTS


Thirty-three patients undergoing elective transthoracic oesophagectomy.
INTERVENTIONS


Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study.
MAIN OUTCOME MEASUREMENTS


Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models.
RESULTS


The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (-0.23, 0.39) in the placebo and 0.00 (-0.24, 0.37) in the GSK2862277 treatment groups. There were no significant treatment-related differences in PaO2/FiO2 or Sequential Organ Failure Assessment score. Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05). The frequency of adverse events and serious adverse events were distributed evenly across the two treatment arms.
CONCLUSION


Pre-operative treatment with a single 26 mg inhaled dose of GSK2862277 did not result in significantly lower postoperative alveolar capillary leak or extra vascular lung water. Unexpectedly small increases in transpulmonary thermodilution-measured PVPI and extra vascular lung water index at completion of surgery suggest less postoperative lung injury than historically reported, which may have also compromised a clear assessment of efficacy in this trial. GSK2862277 was well tolerated, resulted in expected lung exposure and reduced biomarkers of lung permeability and inflammation.
TRIAL REGISTRATION


clinicaltrials.gov: NCT02221037.",2020,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","['patients undergoing oesophagectomy', 'patients at risk of postoperative lung injury', 'Thirty-three patients undergoing elective transthoracic oesophagectomy', 'Eight secondary care centres, the United Kingdom between April 2015 and June 2017']","['GSK2862277', 'nebulised TNFR1 antagonist (GSK2862277', 'nebulised antitumour necrosis factor receptor-1 domain antibody', 'placebo']","['Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints', 'PaO2/FiO2 or Sequential Organ Failure Assessment score', 'postoperative alveolar capillary leak or extra vascular lung water', 'Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein', 'lung exposure and reduced biomarkers of lung permeability and inflammation', 'frequency of adverse events and serious adverse events', 'pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4279387', 'cui_str': 'GSK2862277'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1382398', 'cui_str': 'Increased capillary permeability'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0128546', 'cui_str': 'Small Inducible Cytokine A3'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0039807', 'cui_str': 'Thermodilution'}]",33.0,0.589958,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough (JR), GlaxoSmithKline Research and Development, Stevenage (AIB, TJW, EM,WP, RW, AF), Centre for Experimental Medicine, Queen's University of Belfast (DFM), Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (DFM), Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry (JY, GDP), Birmingham Acute Care Research Group, Institute of Inflammation and Aging, School of Clinical and Experimental Medicine, University of Birmingham (DRT, PAH), University Hospitals Birmingham, NHS Foundation Trust, Birmingham (JY, DRT, PAH, GDP), Department of Anaesthesia, Royal Victoria Hospital, Belfast (COD, MOS), Department of Medicine, University of Cambridge, Cambridge (AMV, CS), GlaxoSmithKline R&D, Stockley Park (KH), Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK (CS) and GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, USA (ALL).""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Bayliffe', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Howells', 'Affiliation': ''}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'Arlette M', 'Initials': 'AM', 'LastName': 'Vassallo', 'Affiliation': ''}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McKie', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hardes', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Shields', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Powley', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001245']
1100,32453209,Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.,"OBJECTIVE


The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.
METHODS


A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.
RESULTS


Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.
CONCLUSIONS


The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.",2020,The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001).,"['stress urinary incontinence (SUI) in females', 'Stress Urinary Incontinence', 'women diagnosed with symptomatic SUI using a self-inserted pessary device', '73 subjects were enrolled and 51 completed the study']",['Disposable Vaginal Device'],"['Safety and Efficacy', 'number of leakage episodes', 'efficacy and safety', 'average pad weight gain', 'quality of life scores', 'number of leakage events and pad weight', 'leakage volume, leakage episodes']","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1273016', 'cui_str': 'Vaginal device'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",73.0,0.0862336,The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001).,"[{'ForeName': 'Omar Felipe', 'Initials': 'OF', 'LastName': 'Duenas-Garcia', 'Affiliation': 'From the Department of Obstetrics and Gynecology, West Virginia University Medical School, Morgantown, WV.'}, {'ForeName': 'Robert Edward', 'Initials': 'RE', 'LastName': 'Shapiro', 'Affiliation': 'From the Department of Obstetrics and Gynecology, West Virginia University Medical School, Morgantown, WV.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gaccione', 'Affiliation': 'Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000861']
1101,32449960,"Assessing consumers' understanding of the term ""Natural"" on food labeling.","The objective of this study was to gain a better understanding of how consumers' interpret the term ""natural"" by assessing food choice based on labels describing attributes of a product associated with the term ""natural""; to assess food intake of chosen food, and; to determine factors that influence food choice and intake. A randomized, single-visit pilot study was conducted where participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label. Participants were asked to choose and eat the granola (ad libitum) that coincided with what was closest to their view of ""natural."" Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness were measured. ""Organic"" (31%), ""Made with real grains"" (17%), and ""No preservatives"" (15%) were the top three chosen labels. These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049). Income level and age were significantly associated with choice (P = 0.003). Defining the term ""natural"" for use on food labels will require follow-up researchacrosseconomically diverse populations and age groups to understand expectations of food products bearing the term ""natural.""",2020,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).",['participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label'],[],"['Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",105.0,0.0447794,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).","[{'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zasadzinski', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}]",Journal of food science,['10.1111/1750-3841.15128']
1102,32462992,Predictors of involuntary and voluntary emotional episodic memories of virtual reality scenarios in Veterans with and without PTSD.,"This study investigated predictors of involuntary and voluntary memories of stressful virtual reality scenarios. Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments. They were randomly assigned to a Recounting (16) or a Suppression (16) condition. After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios. One week later, participants completed surprise voluntary memory tests and another thought suppression task. The best predictors of voluntary memory were verbal memory ability, dissociation, and to a lesser extent, physiological arousal before and after scenarios. Dissociation and physiological stress responses selectively affected memory for neutral elements. Higher distress during scenarios impaired voluntary memory but increased the frequency of involuntary memories. Physiological stress responses promoted more frequent involuntary memories immediately after the scenarios. More frequent initial involuntary memories, tonic physiological arousal, and stronger emotional responses to dangerous events predicted difficulty inhibiting involuntary memories at follow-up. The effects of thought suppression were transient and weaker than those of other variables. The findings suggest that posttraumatic amnesia and involuntary memories of adverse events are more related to memory ability and emotional and physiological stress responses than to post-exposure suppression.",2020,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","['Veterans with and without PTSD', 'Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments']",['surprise voluntary memory tests and another thought suppression task'],"['initial involuntary memories, tonic physiological arousal, and stronger emotional responses', 'frequency of involuntary memories', 'memory ability and emotional and physiological stress responses']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0376439', 'cui_str': 'Persian Gulf'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}]",,0.0230765,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","[{'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Szkodny', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Altemus', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Silbersweig', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}]","Memory (Hove, England)",['10.1080/09658211.2020.1770289']
1103,32460799,Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.,"BACKGROUND


Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.
METHODS


A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week ""Selge"" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models.
DISCUSSION


The ""Selge"" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.",2020,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"['600 individuals', 'alcohol misuse in Estonia']","['cognitive behavioural therapy (CBT) and motivational interviewing (MI', 'minimal-guidance online self-help intervention']","['number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health', 'change in the Alcohol Use Disorders Identification Test (AUDIT) score']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",600.0,0.0620665,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"[{'ForeName': 'Esta', 'Initials': 'E', 'LastName': 'Kaal', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia. esta.kaal@tai.ee.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Ülesoo', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Noormets', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kilp', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}]",BMC public health,['10.1186/s12889-020-08791-6']
1104,32580188,"A Phase 3, Multicenter, Randomized, Two-Arm, Open-Label Study of Intermittent Oral Dosing of Roxadustat for the Treatment of Anemia in Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis.","INTRODUCTION


Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for the treatment of anemia in Japan for patients with dialysis-dependent (DD) chronic kidney disease (CKD).
OBJECTIVE


Multicenter, randomized, open-label, noncomparative, phase 3 study to evaluate roxadustat for anemia of non-dialysis-dependent (NDD) CKD in Japan.
METHODS


Erythropoiesis stimulating agent (ESA)-naïve NDD-CKD patients were randomized to roxadustat (initial dose, 50 or 70 mg 3 times weekly), titrated to maintain hemoglobin (Hb) within 10.0-12.0 g/dL, for ≤24 weeks. Patients with either transferrin saturation of ≥5% or serum ferritin of ≥30 ng/mL during the screening period were eligible. Endpoints included response rate (proportion of patients achieving Hb ≥10.0 or ≥10.5 g/dL and Hb increase ≥1.0 g/dL from baseline) at end of treatment; average Hb (weeks 18-24); change of average Hb from baseline to weeks 18-24; maintenance rate (proportion of patients achieving Hb 10.0-12.0 g/dL at weeks 18-24); rate of rise (RoR) of Hb from weeks 0-4, discontinuation, or dose adjustment. Adverse events were monitored throughout the study.
RESULTS


Of 135 patients who provided informed consent, 100 were randomized and 99 received roxadustat (50 mg, n = 49; 70 mg, n = 50). The mean (SD) dose of roxadustat per intake at week 22 was 36.3 (22.7) mg in the roxadustat 50 mg group and 36.8 (16.0) mg in the roxadustat 70 mg group. Prior medications included oral iron therapy (20.2%) and intravenous iron therapy (1.0%). Overall response rate (95% CI) was 97.0% (91.4, 99.4; Hb ≥10.0 g/dL) and 94.9% (88.6, 98.3; Hb ≥10.5 g/dL). Mean (SD) Hb (weeks 18-24) was 11.17 (0.62) g/dL. Mean (SD) change of Hb from baseline (weeks 18-24) was 1.34 (0.86) g/dL. Maintenance rate (95% CI) was 88.8% (80.3, 94.5) among patients with ≥1 Hb measurement during weeks 18-24. Mean (SD) RoR of Hb was 0.291 (0.197) g/dL/week (50 mg) and 0.373 (0.235) g/dL/week (70 mg). Nasopharyngitis and hypertension were the most common adverse events.
CONCLUSION


Roxadustat increased and maintained Hb in ESA-naïve, partially iron-depleted NDD-CKD patients with anemia.",2020,"Overall response rate (95% CI) was 97.0% (91.4, 99.4;","['anemia of non-dialysis-dependent (NDD) CKD in Japan', 'Patients with either transferrin saturation of ≥5% or serum ferritin of ≥30 ng/mL during the screening period were eligible', '135 patients who provided informed consent, 100 were randomized and 99 received', 'anemia in Japan for patients with dialysis-dependent (DD) chronic kidney disease (CKD', 'Erythropoiesis stimulating agent (ESA)-naïve NDD-CKD patients', 'Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis']","['oral iron therapy', 'roxadustat', 'intravenous iron therapy']","['Nasopharyngitis and hypertension', 'Mean (SD) RoR of Hb', 'Adverse events', 'response rate', 'Overall response rate', 'mean (SD) dose of roxadustat per intake']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",135.0,0.0562269,"Overall response rate (95% CI) was 97.0% (91.4, 99.4;","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan, akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Japan-Asia Clinical Development 2, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Therapeutic Area Medical Specialties, Astellas Pharma Europe B.V., Leiden, The Netherlands.'}]",Nephron,['10.1159/000508100']
1105,32454417,Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.,"BACKGROUND


In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
METHODS


Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m 2  each on day 1, and 5-fluorouracil, 750 mg/m 2 /day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m 2 /day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m 2  of loading dose, 250 mg/m 2 /week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS.
RESULTS


A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively.
CONCLUSIONS


No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.",2020,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","['Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma', '126 TPF-ICT responders', 'laryngeal/hypopharyngeal cancer', '153 patients were enrolled', 'patients with laryngeal/hypopharyngeal cancer']","['radiotherapy (70\xa0Gy) with concurrent cisplatin', 'cisplatin-radiotherapy', 'radiotherapy', 'LEDFS', 'cetuximab', 'conventional chemoradiotherapy', 'induction chemotherapy (ICT', 'Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy', 'cisplatin', 'conventional radiotherapy, bioradiotherapy with cetuximab', 'TPF)-ICT (docetaxel and cisplatin', '5-fluorouracil, 750\xa0mg/m 2', 'docetaxel-cisplatin-5-fluorouracil', 'TPF-ICT followed by conventional chemoradiotherapy or cetuximab']","['laryngo-oesophageal dysfunction-free survival (LEDFS), LCR\xa0and OS', 'LEDFS', 'locoregional control rates (LCRs) and overall survival (OS', 'larynx preservation', 'unmanageable toxicity', 'Late grade III/IV salivary gland and laryngeal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0153398', 'cui_str': 'Malignant tumor of hypopharynx'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}]",153.0,0.178683,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Janoray', 'Affiliation': 'Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D\'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France; EA 7505, ""Education Ethique Santé"", EES, Tours, France. Electronic address: guillaume.janoray@yahoo.fr.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Clinique Sainte Catherine, Avignon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, Lorient, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bardet', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Garaud', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.009']
1106,32458282,EEG Theta/Beta Ratio Neurofeedback Training in Healthy Females.,A growing number of studies suggest that EEG theta/beta ratio (TBR) is inversely related to executive cognitive control. Neurofeedback training aimed at reducing TBR (TBR NFT) might provide a tool to study causality in this relation and might enhance human performance. To investigate whether TBR NFT reduces TBR in healthy participants. Twelve healthy female participants were assigned (single blind) to one of three groups. Groups differed on baseline durations and one group received only sham NFT. TBR NFT consisted of eight or fourteen 25-min sessions. No evidence was found that TBR NFT had any effect on TBR. The current TBR NFT protocol is possibly ineffective. This is in line with a previous study with a different protocol.,2020,No evidence was found that TBR NFT had any effect on TBR.,"['healthy participants', 'Healthy Females', 'Twelve healthy female participants']","['sham NFT', 'Neurofeedback training aimed at reducing TBR (TBR NFT', 'TBR NFT']","['TBR', 'EEG Theta/Beta Ratio Neurofeedback Training', 'EEG theta/beta ratio (TBR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0085400', 'cui_str': 'Neurofibrillary degeneration'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",12.0,0.0266986,No evidence was found that TBR NFT had any effect on TBR.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'van Son', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands. dana.vanson@yale.edu.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van der Does', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Guido P H', 'Initials': 'GPH', 'LastName': 'Band', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Putman', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09472-1']
1107,32463470,Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial.,"Importance


Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed.
Objective


To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type.
Design, Setting, and Participants


This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019.
Interventions


Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study.
Main Outcomes and Measures


Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks.
Results


A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups.
Conclusions and Relevance


Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
Trial Registration


EU Clinical Trials Register Identifier: 2007-005352-17.",2020,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","['Apathy in Alzheimer Disease', '108 patients (mean [SD] age, 74.8 [5.9] years', 'Patients with additional clinically relevant depressed mood were excluded', 'psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany', ' 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive', 'patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood', 'Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included', 'patients with dementia of Alzheimer type']","['Bupropion', 'dopamine and noradrenaline reuptake inhibitor bupropion', 'donepezil or galantamine', 'bupropion or placebo', 'bupropion', 'placebo']","['AES-C score', 'numbers of adverse events', 'health-related quality of life', 'total neuropsychiatric symptoms', 'neuropsychiatric symptoms, cognition, activities of daily living, and quality of life', 'Apathy Evaluation Scale-Clinician Version (AES-C', 'efficacy and safety', 'serious adverse events', 'baseline AES-C score', 'cognition', 'activities of daily living']","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",108.0,0.521266,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood.
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Spottke', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Bach', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Buerger', 'Affiliation': 'Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dodel', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fellgiebel', 'Affiliation': 'Center for Mental Health in Old Age, Landeskrankenhaus, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fliessbach', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Frölich', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Hausner', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Klostermann', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kornhuber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Laske', 'Affiliation': 'German Center for Neurodegenerative Diseases, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Richter-Schmidinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Kija', 'Initials': 'K', 'LastName': 'Shah-Hosseini', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases, Rostock, Germany.'}, {'ForeName': 'Christine A F', 'Initials': 'CAF', 'LastName': 'von Arnim', 'Affiliation': 'Department of Neurology, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiltfang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6027']
1108,32468672,Rationale and study design of OUTSTEP-HF: a randomised controlled study to assess the effect of sacubitril/valsartan and enalapril on physical activity measured by accelerometry in patients with heart failure with reduced ejection fraction.,"AIM


In PARADIGM-HF, sacubitril/valsartan demonstrated superiority to enalapril in reducing mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Several patient-centred outcomes like improved physical activity and quality of life have been emphasised as important treatment goals in HF management. OUTSTEP-HF has been designed to evaluate the effect of sacubitril/valsartan compared with enalapril on non-sedentary daytime physical activity in patients with HFrEF.
METHODS


OUTSTEP-HF is a randomised, actively controlled, double-blind, double-dummy study that plans to enrol 600 ambulatory patients with symptomatic HFrEF in 19 European countries. Patients will be randomised 1:1 to receive sacubitril/valsartan 97/103 mg bid or enalapril 10 mg bid. The primary objective of the study is to assess changes from baseline (Week 0) to Week 12 in exercise capacity measured by the 6-min walk test and in daily non-sedentary daytime activity. Physical activity and objective sleep parameters will be measured by accelerometry using a wrist-worn device, worn continuously from screening (Week -2) until the end of study (Week 12). As a co-primary outcome, changes from baseline in sub-maximal exercise capacity will be assessed by the 6-min walk test. Patient- and physician-reported questionnaires will be used to assess quality of life, changes in signs and symptoms of HF and sleep parameters.
CONCLUSION


OUTSTEP-HF will be the largest randomised trial in HF to date to use non-invasive accelerometry to assess whether treatment with sacubitril/valsartan improves patients' daily physical activity and exercise capacity compared with enalapril.",2020,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"['Patients with Heart Failure with Reduced Ejection Fraction', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', '600 ambulatory patients with symptomatic HFrEF in 19 European countries']","['Sacubitril/Valsartan and Enalapril', 'sacubitril/valsartan 97/103 mg twice-daily (bid) or enalapril 10 mg bid', 'enalapril', 'sacubitril/valsartan', 'OUTSTEP-HF']","['mortality and morbidity', 'Physical Activity', '6-minute walking test', 'physical activity and quality of life (QoL', ""patients' daily physical activity and exercise capacity"", 'sub-maximal exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",600.0,0.170912,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Charité\xa0-\xa0Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht UNiversity, Utrecht, The Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Community Heart Failure Program, Department of Cardiology, Bellvitge University Hospital and Biomedical Research Institute (IDIBELL), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schorr', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ecochard', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rizwan I', 'Initials': 'RI', 'LastName': 'Hussain', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Massimo F', 'Initials': 'MF', 'LastName': 'Piepoli', 'Affiliation': 'Heart Failure Unit, Cardiology Department, G. da Saliceto Hospital, Piacenza, Italy.'}]",European journal of heart failure,['10.1002/ejhf.1919']
1109,32472902,Characterization of unexpected survivors following a prehospital plasma randomized trial.,"BACKGROUND


Prehospital plasma improves survival for severely injured trauma patients transported by air ambulance. We sought to characterize the unexpected survivors, patients who survived despite having high predicted mortality after traumatic injury.
METHODS


The Prehospital Air Medical Plasma trial randomized severely injured patients (n = 501) to receive either standard care (crystalloid) or two units of prehospital plasma followed by standard care fluid resuscitation. We built a generalized linear model to estimate patient mortality. Area under the receiver operating characteristic curve was used to evaluate model performance. We defined unexpected survivors as patients who had a predicted mortality greater than 50% and survived to 30 days. We characterized patient demographics, clinical features, and outcomes of the unexpected survivors. Observed to expected (O/E) ratios and Z-statistics were calculated using model-estimated mortality for each cohort.
RESULTS


Our model predicted mortality better than Injury Severity Score or Revised Trauma Score parameters and identified 36 unexpected survivors. Compared with expected survivors, unexpected survivors were younger (33 years [24, 52 years] vs. 47 years [32, 59 years], p = 0.013), were more severely injured (Injury Severity Score 34 [22, 50] vs. 18 [10, 27], p < 0.001), had worse organ dysfunction and hospital resource outcomes (multiple organ failure, intensive care unit, hospital length of stay, and ventilator days), and were more likely to receive prehospital plasma (67 vs. 46%, p = 0.031). Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (p < 0.001). Unexpected survivors who received prehospital plasma had a lower observed to expected mortality than those that received standard care resuscitation (O/E 0.56 [0.33-0.84] vs. 1.0 [0.73-1.32]). The number of prehospital plasma survivors (24) exceeded the number of predicted survivors (n = 10) estimated by our model (p < 0.001).
CONCLUSION


Prehospital plasma is associated with an increase in the number of unexpected survivors following severe traumatic injury. Prehospital interventions may improve the probability of survival for injured patients with high predicted mortality based on early injury characteristics, vital signs, and resuscitation measures.
LEVEL OF EVIDENCE


Therapeutic Level III.",2020,Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (P<0.001).,"['The Prehospital Air Medical Plasma (PAMPer) trial randomized severely injured patients (n=501) to receive either', 'patients who survived despite having high predicted mortality following traumatic injury', 'severely injured trauma patients transported by air ambulance']",['standard care (crystalloid) or two units of prehospital plasma followed by standard care fluid resuscitation'],"['probability of survival', 'number of prehospital plasma survivors', 'survival', 'mortality', 'prehospital plasma', 'worse organ dysfunction and hospital resource outcomes (MOF, ICU and hospital length of stay, and ventilator days']","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0206185', 'cui_str': 'Air transport ambulance'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.107682,Nonsurvivors with high predicted mortality were more likely to receive standard care resuscitation (P<0.001).,"[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Gruen', 'Affiliation': 'From the Department of Surgery (D.S.G., J.B.B., M.D.N., B.S.Z., J.L.S.), University of Pittsburgh; Division of Trauma and Acute Care Surgery (D.S.G., J.B.B., M.D.N., B.S.Z., J.L.S.), Pittsburgh Trauma Research Center; Department of Emergency Medicine (F.X.G.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (B.J.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.S.M.), Vanderbilt University Medical Center, Nashville, Tennessee; University of Louisville (B.G.H.), Louisville, Kentucky; MetroHealth Medical Center (J.A.C.), Case Western Reserve University, Cleveland, Ohio; Department of Surgery (H.A.P.), University of Texas Southwestern, Parkland Memorial Hospital, Dallas, Texas; and Department of Pathology (M.H.Y.), University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002816']
1110,32471400,"Effectiveness of a family intervention on health-related quality of life-a healthy generation, a controlled pilot trial.","BACKGROUND


Physical activity is associated with better health, but knowledge about health promoting interventions, including physical activity for families in disadvantaged areas and the impact on health-related quality of life (HRQOL) is sparse. The aim of this study was to assess HRQOL in children and their parents after participation in the programme ""A Healthy Generation"".
METHODS


The programme is delivered in socioeconomically disadvantaged areas in Sweden and offers physical activity and a healthy meal or fruit twice a week from August to May to families with children in grade 2. Children (n = 67), aged 8-9 years, and their parents (n = 90) participated in this controlled study conducted in four schools, two control and two intervention schools. HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively. Analyses of covariance (ANCOVAs), linear regression and Pearson's correlation were conducted.
RESULTS


There were no significant differences between intervention and control in HRQOL among children or adults after the intervention. However, in a subgroup of children (n = 20) and adults (n = 29) with initial low HRQOL scores at baseline, there was a significant difference between the intervention group and control group after the intervention (children (total score): p = 0.02; adults (social domain) p = 0.04). Furthermore, within the intervention group, there was a significant relationship between level of participation in ""A Healthy Generation"" and the physical domain of HRQOL among girls (r = 0.44, p = 0.01), but not boys (r = - 0.07, p = 0.58).
CONCLUSION


Participation in the programme ""A Healthy Generation"" did not show a significant intervention effect on HRQOL in general. However, the findings suggest that HRQOL may be increased for children and adults with low HRQOL in disadvantaged areas. This knowledge can contribute to the development of health promoting interventions in such areas, and to more equitable health.
TRIAL REGISTRATION


ISRCTN ISRCTN11660938. Retrospectively registered 23 September 2019.",2020,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","['children and their parents after participation in the programme ""A Healthy Generation', 'children and adults with low HRQOL in disadvantaged areas', 'Children (n\u2009=\u200967), aged 8-9\u2009years, and their parents (n\u2009=\u200990) participated in this controlled study conducted in four schools, two control and two intervention schools']",['family intervention'],"['HRQOL', 'Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale', 'level of participation in ""A Healthy Generation"" and the physical domain of HRQOL', 'health-related quality of life-a healthy generation', 'initial low HRQOL scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0628145,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Susanne.andermo@ki.se.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Hedby', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, Stockholm, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC public health,['10.1186/s12889-020-08895-z']
1111,32458473,Effectiveness of nurse-led group CBT for hot flushes and night sweats in women with breast cancer: Results of the MENOS4 randomised controlled trial.,"OBJECTIVE


Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS.
METHODS


We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life.
RESULTS


Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly.
CONCLUSION


Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.",2020,Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.,"['130 participants were recruited (CBT:63, control:67', 'Between 2017-2018', 'recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial', 'women with breast cancer']","['nurse-led group CBT', 'Group CBT or usual care (UC', 'CBT delivered by breast care nurses (BCNs', 'Cognitive behavioural therapy (CBT']","['frequency of HFNS, sleep, anxiety and depression all improved significantly', 'mean HFNS problem rating score', 'HFNS problem rating', 'sleep, depression, anxiety and quality of life']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",130.0,0.118211,Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fenlon', 'Affiliation': 'Department Nursing, College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Nuttall', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ellis', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Turner', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Fields', 'Affiliation': 'Ladybird Unit, Poole Hospital NHS Trust, Poole, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Myra S', 'Initials': 'MS', 'LastName': 'Hunter', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Psycho-oncology,['10.1002/pon.5432']
1112,32460748,The safe use of dating applications among men who have sex with men: a study protocol for a randomised controlled trial to evaluate an interactive web-based intervention to reduce risky sexual behaviours.,"BACKGROUND


Notably, both international and local studies have found a high prevalence of sexually transmitted infections (STIs) and risky sexual behaviours, such as condomless anal sex, substance misuse in conjunction with sex ('chemsex') and group sex, among men who have sex with men (MSM) dating application (app) users. Although the use of dating apps is an emerging sexual risk factor, little effort has been expended on the promotion of safe sex and good sexual health among the users of those apps. Therefore, the aim of the proposed study is to develop and evaluate the effectiveness of an interactive web-based intervention in improving the sexual health of MSM dating app users in Hong Kong.
METHODS


A two-armed randomised controlled trial will be conducted. Chinese MSM dating app users will be recruited and randomly allocated into either the intervention (n = 200) or control group (n = 200). Subjects in the intervention group will receive the web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing. The control group will receive only web-based information without sexual health components. Subjects in both groups will be evaluated at baseline and three and 6 months after baseline. The primary outcome will be the frequency of condomless anal sex in the past 3 months.
DISCUSSION


The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users. The web-based intervention, if found successful, will have important clinical and policy implications, as it can be adopted by the government and non-governmental organisations targeting MSM. Moreover, the proposed intervention can reach many MSM at relatively low cost, and thus has the potential to check the burgeoning HIV/STI epidemic among MSM in Hong Kong in a cost-effective manner.
TRIAL REGISTRATION


International standard randomized controlled trial number (ISRCTN) registry: ISRCTN16681863 registered on 28 April 2020.",2020,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"['men who have sex with men (MSM) dating application (app) users', 'MSM dating app users in Hong Kong', 'Chinese MSM dating app users', 'men who have sex with men']","['web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing', 'control group will receive only web-based information without sexual health components', 'interactive web-based intervention']","['risky sexual behaviours', 'frequency of condomless anal sex in the past 3\u2009months']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0901602,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"[{'ForeName': 'Edmond P H', 'Initials': 'EPH', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong. h0714919@connect.hku.hk.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Janet Y H', 'Initials': 'JYH', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Daniel Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}]",BMC public health,['10.1186/s12889-020-08914-z']
1113,32467323,"Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: the first multicentre, phase III trial in China.","BACKGROUND AND PURPOSE


Data on the efficacy and safety of alteplase for acute ischaemic stroke (AIS) administered 3-4.5 hours after the onset of stroke symptoms in Chinese patients is limited. We sought to determine whether AIS patients would benefit from thrombolysis with alteplase between 3 and 4.5 hours after the onset of stroke symptoms in a prospective, multicentre, single-arm trial in China.
MATERIALS AND METHODS


Eligible AIS patients were given 0.9 mg/kg alteplase intravenously. The primary efficacy endpoint was a favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale. Thresholds for the primary efficacy endpoint were determined to be 40% based on the literature review. The primary safety endpoint was symptomatic intracranial haemorrhage (sICH) according to the European Cooperative Acute Stroke Study III (ECASS III) trial definition. Post hoc analysis between this study and the ECASS III trial were compared using the propensity score matching (PSM) method.
RESULTS


A total of 120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study. The median time from onset of symptoms to needle was 3 hours 54 min. The percentage of patients with a favourable outcome was 63.3% (95% CI 54.4 to 71.4), significantly higher than the predefined threshold (p<0.0001). Three patients (2.5%, 95% CI 0.5 to 7.1) had sICH, including two fatal sICH. Six patients died within 3 months after treatment. The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
CONCLUSIONS


Intravenous alteplase with a standard dose administered between 3 and 4.5 hours after onset of symptoms is effective and safe for Chinese AIS patients.
TRIAL REGISTRATION NUMBER


NCT02930837.",2020,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","['120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study', 'Chinese AIS patients', 'Chinese patients', 'Eligible AIS patients']","['alteplase', 'Intravenous alteplase', 'placebo']","['symptomatic intracranial haemorrhage (sICH', 'favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale', 'median time from onset of symptoms to needle']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",120.0,0.198498,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","[{'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Chuanling', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yangkun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Neurology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Fu-Dong', 'Initials': 'FD', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, No.900 Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Zuneng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Songbiao', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, Yanbian University Hospital, Yanji, China.'}, {'ForeName': 'Anding', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'Neurology, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000337']
1114,32468955,Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial.,"PURPOSE


In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.
PATIENTS AND METHODS


Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease.
RESULTS


There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48;  P  < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85;  P  = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
CONCLUSION


In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.",2020,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","['patients with HER2-positive breast cancer', 'Patients', 'Previously Treated HER2-Positive Breast Cancer', 'participants with BMs', 'patients with HER2-positive breast cancer with BMs', '291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm', 'patients with measurable intracranial disease', 'patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs']","['baseline brain magnetic resonance imaging', 'Tucatinib Plus Trastuzumab and Capecitabine', 'tucatinib or placebo, in combination with trastuzumab and capecitabine']","['risk of intracranial progression or death', 'Risk of death', 'ORR-IC', 'Median OS', 'risk of death', 'intracranial efficacy and survival', 'Median CNS-PFS', 'Intracranial Efficacy and Survival', 'intracranial objective response rate (ORR-IC', 'antitumor activity against BMs', 'CNS-PFS (intracranial progression or death) and overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]",291.0,0.139198,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","[{'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Anders', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology-Nashville, Nashville, TN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles Medical Center/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'Royal Marsden National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Hospital Universitario Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Zelnak', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'DiGiovanna', 'Affiliation': 'Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Regan"", 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'Christie NHS Foundation Trust, Manchester Academic Health Science Centre & Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Providence Cancer Institute, Portland, OR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Cancer Research Centre, Edinburgh, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, University of Milano, Milan, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer-Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'JoAl', 'Initials': 'J', 'LastName': 'Mayor', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGoldrick', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Xuebei', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00775']
1115,32470515,Ramipril in High-Risk Patients With COVID-19.,"BACKGROUND


Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory-syndrome coronavirus-2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2. This interaction has been proposed as a potential risk factor in patients treated with RAAS inhibitors.
OBJECTIVES


This study analyzed whether RAAS inhibitors modify the risk for COVID-19.
METHODS


The RASTAVI (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial is an ongoing randomized clinical trial randomly allocating subjects to ramipril or control groups after successful transcatheter aortic valve replacement at 14 centers in Spain. A non-pre-specified interim analysis was performed to evaluate ramipril's impact on COVID-19 risk in this vulnerable population.
RESULTS


As of April 1, 2020, 102 patients (50 in the ramipril group and 52 in the control group) were included in the trial. Mean age was 82.3 ± 6.1 years, 56.9% of the participants were male. Median time of ramipril treatment was 6 months (interquartile range: 2.9 to 11.4 months). Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving ramipril; hazard ratio: 1.150; 95% confidence interval: 0.351 to 3.768). The risk of COVID-19 was increased in older patients (p = 0.019) and those with atrial fibrillation (p = 0.066), lower hematocrit (p = 0.084), and more comorbidities according to Society of Thoracic Surgeons score (p = 0.065). Admission and oxygen supply was required in 4.9% of patients (2 in the ramipril group and 3 in the control group), and 4 of them died (2 in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p = 0.039).
CONCLUSIONS


In a high-risk population of older patients with cardiovascular disease, randomization to ramipril had no impact on the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS inhibitor treatment during the COVID-19 crisis. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185).",2020,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","['High Risk Patients with COVID-19', 'patients treated with RAAS-inhibitors', '102 patients (50 Ramipril and 52 controls) were included in the trial', 'Mean age was 82.3±6.1 years, 56.9% males']",['Ramipril'],"['Admission and oxygen supply', 'mortality rate', 'risk of COVID-19', 'atrial fibrillation', 'incidence or severity of COVID-19', 'Median time']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.117341,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","[{'ForeName': 'Ignacio J', 'Initials': 'IJ', 'LastName': 'Amat-Santos', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain. Electronic address: ijamat@gmail.com.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Santos-Martinez', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'López-Otero', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Cardiovascular Institute, Hospital Clínico San Carlos, El Instituto de Investigación Sanitaria San Carlos, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez-Ibanes', 'Affiliation': 'CIBERCV, Hospital General Gregorio Marañón and Universidad Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Del Valle', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Muñoz-García', 'Affiliation': 'CIBERCV, Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Víctor A', 'Initials': 'VA', 'LastName': 'Jiménez-Diaz', 'Affiliation': 'Hospital Universitario de Vigo, Vigo, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': 'Hospital Clinic Univeristari, Barcelona, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'González-Ferreiro', 'Affiliation': 'Hospital Clínico Universitario, Salamanca, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Benito', 'Affiliation': 'Hospital Universitario de León, León, Spain.'}, {'ForeName': 'Xoan Carlos', 'Initials': 'XC', 'LastName': 'Sanmartin-Pena', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Catalá', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Rodríguez-Gabella', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Jose Raúl', 'Initials': 'JR', 'LastName': 'Delgado-Arana', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carrasco-Moraleja', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibañez', 'Affiliation': 'CIBERCV, Centro Nacional de Investigaciones Cardiovasculares, IIS-Hospital Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'San Román', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.040']
1116,32474564,Oral S-1 with 24-h Infusion of Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab as First-Line Chemotherapy for Metastatic Colorectal Cancer: An Open-Label Randomized Phase II Trial.,"BACKGROUND


FOLFIRI plus bevacizumab have been widely used as first-line treatment for metastatic colorectal cancer (mCRC). Pharmacokinetics and pharmacodynamics suggested a low dose of irinotecan given as a long-term infusion is expected to enhance antitumor activity. We conducted a randomized phase II study to compare oral S-1 with a 24-h infusion of irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab.
METHODS


The subjects comprised 120 chemotherapy-naïve patients with mCRC. The study group received a 24-h infusion of irinotecan at a dose of 125 mg/m2 on days 1 and 15, combined with oral S-1 80 mg/m2 on days 1-14 (24h-SIRI/B). The FOLFIRI/B group received irinotecan at a dose of 150 mg/m2, 5-fluorouracil given at a dose of 400 mg/m2 as a bolus injection and at a dose of 2,400 mg/m2 as a 46-h infusion, and 200 mg/m2 leucovorin on days 1 and 15. Bevacizumab was given at a dose of 5.0 mg/kg on days 1 and 15 in both groups. Treatment was repeated every 4 weeks. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were PFS, response rates (RR), overall survival (OS), and adverse events (AEs).
RESULTS


From December 2013 through January 2018, 120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B. The median follow-up period was 22.8 months. The 1-year PFS rate was 43.14% in the 24h-SIRI/B arm and 19.15% in the FOLFIRI/B arm (HR = 0.312 [95%CI 0.13-0.78], p = 0.01). The median PFS was 10.2 months (95%CI 8.8-14.3) and 10.0 months (95%CI 7.4-11.0), and the median OS was 29.7 months (95%CI 22.9-43.9) and 28.8 months (95%CI 18.4-ND), respectively (p = 0.3758, p = 0.8234). The overall RR was 86.3 and 61.7%, respectively (p = 0.0053). AEs were similar.
CONCLUSIONS


Our results show that the 24h-SIRI/B regimen is an effective and reasonably well-tolerated regimen for the first-line treatment of mCRC.",2020,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","['metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer', 'From December 2013 through January 2018', 'subjects comprised 120 chemotherapy-naïve patients with mCRC', '120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B']","['leucovorin', 'Bevacizumab', 'Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab', 'irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab', '5-fluorouracil', 'irinotecan', 'bevacizumab']","['median OS', '1-year PFS rate', 'PFS, response rates (RR), overall survival (OS), and adverse events (AEs', '1-year progression-free survival (PFS', 'overall RR', 'median PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.214759,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","[{'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan, sadahiro@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Kazutake', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Gota', 'Initials': 'G', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyakita', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogimi', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Lin Fung', 'Initials': 'LF', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}]",Oncology,['10.1159/000507293']
1117,32476465,Comparison of Anticoagulants for Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Pilot Study.,"BACKGROUND


Direct-acting oral anticoagulants are indicated for the treatment of nonvalvular atrial fibrillation, but their use in patients after undergoing cardiac surgery is poorly defined despite a high prevalence of postoperative atrial fibrillation in this population.
METHODS


Patients diagnosed with postoperative atrial fibrillation were prospectively randomized to warfarin or apixaban. Safety, efficacy, and economic outcomes were evaluated until their 4- to 6-week postoperative appointment.
RESULTS


While this pilot study was not powered to determine a difference in safety or efficacy, adverse event rates were similar to the published literature. It was noted that a patient's course of therapy when utilizing apixaban was significantly less costly than warfarin when including medication, bridging, and laboratory expenses.
CONCLUSION


Apixaban and warfarin both appeared to be safe and effective for anticoagulation throughout the duration of this pilot study in treating postoperative atrial fibrillation after coronary artery bypass grafting. Apixaban was associated with significantly less expense when bridging and monitoring costs were included in addition to medication expense.",2020,"RESULTS


While this pilot study was not powered to determine a difference in safety or efficacy","['Patients diagnosed with postoperative atrial fibrillation', 'patients after undergoing cardiac surgery']","['warfarin or apixaban', 'Coronary Artery Bypass Grafting', 'Anticoagulants', 'warfarin', 'Apixaban and warfarin', 'Apixaban']","['adverse event rates', 'safety or efficacy', 'Safety, efficacy, and economic outcomes', 'Postoperative Atrial Fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.119252,"RESULTS


While this pilot study was not powered to determine a difference in safety or efficacy","[{'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Chapin', 'Affiliation': 'Pharmacy Services, 23506Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Leedahl', 'Affiliation': 'Pharmacy Services, 23506Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Brown', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Pasek', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Mitchell G', 'Initials': 'MG', 'LastName': 'Sand', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Maari L', 'Initials': 'ML', 'LastName': 'Loy', 'Affiliation': 'Pharmacy Services, 275292Essentia Health, Fargo, ND, USA.'}, {'ForeName': 'Cornelius M', 'Initials': 'CM', 'LastName': 'Dyke', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420929483']
1118,32476469,The effect of the visual exercise environment on the response to psychological stress: a pilot study.,"Background:  Performing physical activity whilst exposed to nature can improve health. However, there is little evidence of its impact on stress outcomes. The aim of this study was to examine the influence of the visual exercise environment on the response to a psychosocial stressor.  Methods:  Eighteen participants were randomized to one of three conditions: i. nature; ii. built or; iii. control condition. Participants exercised for 30 min on a treadmill at 50% of their VO 2 max whilst viewing a video of either a natural or built environment or a blank screen. Following the exercise, participants completed the Trier Social Stress Test (TSST), a standardized laboratory stressor. Salivary samples were collected before, during and after the TSST to calculate cortisol reactivity and recovery.  Results:  One-way ANOVA revealed a significant effect of viewing condition on cortisol reactivity [ F   (2, 11)  = 4.686,  p  = .034;  n   2   p      = .460]; with significantly lower reactivity in the built compared to the nature condition ( p  = .027,  d =  1.73). There was no effect of condition on cortisol recovery ( p  = .137;  n   2   p   = .257).  Conclusions:  In the context of the adverse health impact of lower (i.e., blunted) cortisol responding, these findings could indicate a negative impact of the built environment on stress responses.",2020,There was no effect of condition on cortisol recovery ( p  = .137;  n 2   p  = .257).,['Eighteen participants'],"['VO 2 max whilst viewing a video of either a natural or built environment or a blank screen', 'Trier Social Stress Test (TSST', 'visual exercise environment']","['cortisol reactivity', 'cortisol recovery']","[{'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",18.0,0.037352,There was no effect of condition on cortisol recovery ( p  = .137;  n 2   p  = .257).,"[{'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Colchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Naufahu', 'Affiliation': 'School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Smyth', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1770231']
1119,32484441,Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial.,"BACKGROUND


Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes.
OBJECTIVE


This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia.
METHODS


Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs.
RESULTS


Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6).
CONCLUSIONS


The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants' knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.",2020,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"['Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40', 'patients with dementia', 'Continuous Professional Education on Dementia', 'patients with various conditions']","['8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group', 'continuous professional education program utilizing Facebook', 'Facebook']","['total DKAS scores, scores of other DKAS subscales, and multiple choice questions', 'mean numbers of participants accessing the learning materials', 'mean of changes in scores', 'means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions', 'participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs', 'DKAS subscale Communication and Behavior', 'overall retention rate', 'Participant compliance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.081195,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, China (Hong Kong).'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16772']
1120,32466676,Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial.,"BACKGROUND


Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited.
METHODS


The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization.
RESULTS


At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent ( P =0.55). Rates of cardiac death (3.9% versus 3.8%;  P =0.88), target vessel myocardial infarction (3.2% versus 2.5%;  P =0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%;  P =0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%;  P =0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%;  P =0.34).
CONCLUSIONS


In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.",2020,The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent.,[],"['ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent', 'MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent', 'novel ultrathin drug-eluting stent', 'MiStent sirolimus-eluting bioabsorbable polymer-coated stent', 'MiStent Sirolimus Eluting Absorbable Polymer Stent System']","['device-oriented composite end point', 'risk of patient-oriented composite end point', 'Rates of cardiac death', 'target vessel myocardial infarction', 'device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization', 'rate of definite or probable stent thrombosis', 'target lesion revascularization', 'composite of all-cause mortality, any myocardial infarction, or any revascularization']",[],"[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.070461,The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent.,"[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG) (P.W.S., Y.O.).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Department of Epidemiology and Statistics, Medical University of Silesia, Katowice, Poland (P.B.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University Leipzig, Germany (P.L.).'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Emmen, the Netherlands (G.A.J.J.).'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Roland P T', 'Initials': 'RPT', 'LastName': 'Troquay', 'Affiliation': 'Department of Cardiology, VieCuri Medical Centre for Northern Limburg, Venlo, the Netherlands (R.P.T.T.).'}, {'ForeName': 'B J B', 'Initials': 'BJB', 'LastName': 'Hamer', 'Affiliation': 'Department of Cardiology, Meander Medisch Centrum, Amersfoort, the Netherlands (B.J.B.H.).'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Oude Ophuis', 'Affiliation': 'Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.).'}, {'ForeName': 'Krzysztof P', 'Initials': 'KP', 'LastName': 'Milewski', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron (P.B., K.P.M.).'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (S.H.H.).'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG) (P.W.S., Y.O.).'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway (W.W.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008737']
1121,32466710,Effects of acute alcohol consumption on emotion recognition in high and low trait aggressive drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption impairs processing of emotional faces. As emotion processing plays a key role in effective social interaction, these impairments may be one mechanism by which alcohol changes social behaviour. This study investigated the effect of individual differences on this relationship by comparing emotion recognition performance after acute alcohol consumption in individuals with high and low trait aggression.
METHODS


Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive). Participants attended two sessions. In one they consumed an alcoholic drink (0.4 g/kg) and in the other they consumed a matched placebo. They then completed two computer-based tasks: one measured global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad).
RESULTS


There was evidence of poorer global emotion recognition after alcohol. In addition, there was evidence of poorer sensitivity to sadness and fear after alcohol. There was also evidence for a reduced bias towards happiness following alcohol and weak evidence for an increased bias towards sadness.
CONCLUSIONS


These findings suggest that alcohol impairs global emotion recognition. They also highlight a reduced ability to detect sadness and fearful facial expressions. As sadness and fear are cues of submission and distress (i.e. function to curtail aggression), failure to successfully detect these emotions when intoxicated may increase the likelihood of aggressive responding. This coupled with a reduced bias towards seeing happiness may collectively contribute to aggressive behaviour.",2020,There was evidence of poorer global emotion recognition after alcohol.,"['individuals with high and low trait aggression', 'Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive', 'high and low trait aggressive drinkers']","['acute alcohol consumption', 'alcoholic drink', 'placebo']","['poorer global emotion recognition', 'global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad', 'global emotion recognition', 'emotion recognition', 'emotion recognition performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",,0.189109,There was evidence of poorer global emotion recognition after alcohol.,"[{'ForeName': 'Andrew Pr', 'Initials': 'AP', 'LastName': 'Eastwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922951']
1122,32469156,Diuretic and renal effects of spironolactone and heart failure hospitalizations: a TOPCAT Americas analysis.,"AIMS


It is unclear whether spironolactone reduced heart failure (HF) hospitalizations in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial through potential diuretic or other effects. We examined the effects of spironolactone on weight, diuretic use, and renal function, and their subsequent impact on outcomes.
METHODS AND RESULTS


We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm). We used mixed-effects models for serial data and shared frailty models to identify determinants of recurrent HF hospitalizations among baseline and serial parameters. There were 800 HF hospitalizations after a median of 3.0 years. Despite more weight loss with spironolactone initially, weight trajectories overlapped after 12 months. Daily furosemide dose (time-averaged Δ: -4.8% vs. +11.6%, P < 0.001) and thiazide use (-4.3% vs. +1.7%; P = 0.003) decreased with spironolactone; however, angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) use decreased also (-13.1% vs. -7.3%; P = 0.004). Serum creatinine increased more with spironolactone (+12.5% vs. +3.5%; P < 0.001). In time-updated models, loop diuretic dose [hazard ratio (HR) per doubling 1.21; 95% confidence interval (CI) 1.10-1.32; P < 0.001], creatinine (HR per doubling 1.28; 95% CI 1.04-1.40; P = 0.019), and ACEI/ARB use (HR 0.82; 95% CI 0.67-1.00; P = 0.048) were associated with HF hospitalizations. However, the effect of spironolactone on HF hospitalizations persisted (HR 0.77; 95% CI 0.62-0.96; P = 0.021) in these models. Results were similar for cardiovascular mortality and time to first HF hospitalization.
CONCLUSIONS


In TOPCAT Americas, the benefit of spironolactone on outcomes could not be solely attributed to potential diuretic effects, suggesting the presence of non-diuretic mechanisms.",2020,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","['We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm', 'and Heart Failure Hospitalizations']","['spironolactone', 'Daily furosemide', 'Spironolactone', 'Aldosterone Antagonist (TOPCAT', 'thiazide']","['weight, diuretic use, and renal function', 'weight trajectories', 'HF hospitalizations', 'heart failure (HF) hospitalizations', 'Serum creatinine', 'cardiovascular mortality and time to first HF hospitalization', 'weight loss', 'ACEi/ARB']","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]",1767.0,0.0687118,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","[{'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Jincy', 'Initials': 'J', 'LastName': 'Thankachen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}]",European journal of heart failure,['10.1002/ejhf.1917']
1123,32469414,Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease: A Qualitative Study.,"Importance


Bone marrow transplant (BMT) is a potentially curative treatment for sickle cell disease (SCD). Patient and caregiver attitudes toward BMT for SCD and the willingness to accept risks of BMT vary, but these attitudes are not well understood.
Objective


To understand patient and caregiver perceptions of and attitudes toward BMT for SCD and decision-making about BMT.
Design, Setting, and Participants


Qualitative study of interview transcripts from a convenience sample. Transcripts were from adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities. Interview transcripts were used from the needs assessment phase to develop a patient-decision aid in 2013 to 2014 (group 1) and from the baseline point in 2015 to 2016 (group 2) of the parent trial, a randomized clinical trial of adults and caregivers of patients with SCD to evaluate the effectiveness of a patient decision aid.
Main Outcomes and Measures


Participant perspectives on decision-making regarding BMT for SCD.
Results


Fifty-seven transcripts from adults with SCD and 50 transcripts from caregivers of patients with SCD were included. Median (interquartile range [IQR]) age of adults with SCD was 34 (21-50) years in group 1 and 30 (23-38) years in group 2. The median (IQR) age of caregivers was 42.5 (31-52) years in group 1 and 41 (35-46.5) years in group 2. Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants. Bone marrow transplant was perceived as a treatment option associated with serious risks. Reported attitudes toward BMT occurred on a continuum ranging from unfavorable to favorable. Participants reported serious decisional dilemma regarding BMT for SCD. Most participants expressed interest in learning about BMT or curative treatments.
Conclusions and Relevance


This qualitative study found a continuum in attitudes toward BMT for SCD and highlights the complexity of decision-making in BMT for SCD. Patients and families with SCD expressed an interest in learning about BMT. Future prospective studies of patient decision-making regarding BMT, especially in the context of emerging curative and novel disease-modifying therapies for SCD, are warranted.",2020,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"['adults with SCD and 50 transcripts from caregivers of patients with SCD', 'sickle cell disease (SCD', 'adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities', 'Sickle Cell Disease']",['Importance\n\n\nBone marrow transplant (BMT'],['decision-making regarding BMT for SCD'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",,0.0344463,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"[{'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Katoch', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6742']
1124,32471404,Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,"BACKGROUND


Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls.
METHODS


The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes.
RESULTS


A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22). Overall there were 36.4% improvement for knowledge (η p 2  = 0.21), 53.2% for the skills (η p 2  = 0.25), 19.5% for the self-efficacy (η p 2  = 0.11), and 25.6% for the beliefs (η p 2  = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time.
CONCLUSION


The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies.
TRIAL REGISTRATION


Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.",2020,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","['104 schoolchildren aged 11\u2009±\u20091.0\u2009years', 'spine-related behavior among pupils']","['theory-based back care intervention', 'six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing', 'educational program']","['rate of backache', 'knowledge, skills, self-efficacy, beliefs, and behavior', 'knowledge', 'knowledge, skills, beliefs, and self-efficacy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",104.0,0.0707787,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-08566-z']
1125,32471469,Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol.,"BACKGROUND


Intimate partner violence (IPV) is a leading threat to women's health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya.
METHODS


A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman's inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group.
DISCUSSION


Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited.
TRIAL REGISTRATION


Pan African Clinical Trial Registry approval received 25 April 2018 (PACTR201804003321122); retrospectively registered.",2020,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","['Intimate partner violence (IPV', 'women in low and middle income country settings', 'women reporting IPV or fear of partner and living in an urban settlement']",['community-partnered\xa0technology-based IPV intervention'],"['safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.147335,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA. mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}]",BMC public health,['10.1186/s12889-020-08901-4']
1126,32478802,Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis.,"Importance


Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice.
Objective


To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis.
Design, Setting, and Participants


This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples.
Exposures


Receipt of CEA vs initial medical therapy.
Main Outcomes and Measures


Fatal and nonfatal strokes.
Results


Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, -0.8%; 95% CI, -2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, -2.1%; 95% CI, -4.4% to -0.2%). Accounting for competing risks resulted in a risk difference of -0.9% (95% CI, -2.9% to 0.7%) that was not statistically significant.
Conclusions and Relevance


This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy.",2020,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","['asymptomatic patients', 'Patients With Asymptomatic Carotid Stenosis', 'total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received', 'August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs', 'veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009', 'patients with asymptomatic carotid stenosis']","['CEA', 'initial medical therapy', 'Carotid endarterectomy (CEA', 'CEA vs initial medical therapy', 'Carotid Endarterectomy vs Initial Medical Therapy', 'early intervention (CEA']","['rate of stroke or death (perioperative complications', 'history of stroke or transient ischemic attack', 'nonstroke deaths', 'risk of fatal and nonfatal strokes', 'fatal and nonfatal strokes', '5-year risk of fatal and nonfatal strokes', 'Cumulative incidence functions for fatal and nonfatal strokes', 'Measures\n\n\nFatal and nonfatal strokes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4505078', 'cui_str': 'Data Warehouse'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0203382', 'cui_str': 'Imaging of carotid arteries'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",5221.0,0.184697,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","[{'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, UCLA (University of California Los Angeles), Los Angeles.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Hoggatt', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Austin', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Madden', 'Affiliation': 'Northern California Institute of Research and Education, San Francisco.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hebert', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Naseri', 'Affiliation': 'San Francisco Veterans Affairs (VA) Medical Center, San Francisco, California.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johanning', 'Affiliation': 'Department of Surgery, University of Nebraska, Omaha.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mowery', 'Affiliation': 'Biomedical Informatics, University of Utah, Salt Lake City.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Chapman', 'Affiliation': 'University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1427']
1127,32479591,Effect of an integrated care model for pre-frail and frail older people living in community.,"OBJECTIVES


to evaluate the effect of an integrated care model for pre-frail and frail community-dwelling older people.
DESIGN


a quasi-experimental design.
SETTING AND PARTICIPANTS


we enrolled people aged ≥60 years from a community care project. An inclusion criterion was pre-frailty/frailty, as measured by a simple frailty questionnaire (FRAIL) with a score of ≥1.
METHODS


we assigned participants to an intervention group (n = 183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n = 270) in which they received a group education session on frailty prevention. The outcomes were changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation over 12 months. Assessments were conducted at baseline and at the 12-month follow-up.
RESULTS


the mean age of the participants (n = 453) at baseline was 76.1 ± 7.5 years, and 363 (80.1%) were women. At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033). In addition, 22.4% of the intervention and 13.7% of the control participants had reverted from pre-frail/frail to robust status, with the difference reaching significance when the intervention was compared with the control group (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.0-2.4) after adjustments for age, sex, living arrangement/marital status and hypercholesterolemia. For individual domains of frailty, the adjusted OR for improved 'resistance' was 1.7 (95% CI 1.0-2.8). However, no effects were found on reducing use of health services.
CONCLUSION


the integrated health and social care model reduced FRAIL scores in a combined population of pre-frail/frail community-dwelling older people attending older people's centres.",2020,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","['pre-frail and frail community-dwelling older people', 'enrolled people aged ≥60\xa0years from a community care project', ""combined population of pre-frail/frail community-dwelling older people attending older people's centres"", 'the mean age of the participants (n\u2009=\u2009453) at baseline was 76.1\u2009±\u20097.5\xa0years, and 363 (80.1%) were women', 'pre-frail and frail older people living in community']","['integrated care model', 'intervention group (n\u2009=\u2009183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n\u2009=\u2009270) in which they received a group education session on frailty prevention']","['FRAIL scores', ""changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation""]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0395423,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","[{'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}]",Age and ageing,['10.1093/ageing/afaa087']
1128,32488989,Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.,"The aim of this phase 1 study was to determine the effects of sapanisertib on the heart rate-corrected QT (QTc) interval in patients with advanced solid tumors. Adult patients with advanced solid tumors were enrolled to receive a single sapanisertib 40-mg dose. Blood samples for pharmacokinetic analysis were collected and electrocardiogram readings were recorded at baseline and up to 48 hours after dosing. Patients could continue to receive sapanisertib 30 mg once weekly in 28-day cycles for up to 12 months. The primary objective was to characterize the effect of a single dose of sapanisertib (40 mg) on the QT interval. Secondary objectives were to evaluate safety, tolerability, and pharmacokinetics. Following a single sapanisertib 40-mg dose in 44 patients, the maximum least squares mean (upper bound of 1-sided 95% confidence interval) changes from time-matched baseline were 7.1 milliseconds (11.4 milliseconds) for individual rate-corrected QT interval at 24 hours after dosing, and 1.8 milliseconds (5.6 milliseconds) for Fridericia-corrected QTc at 1 hour post-dose. There was no sapanisertib plasma concentration-dependent increase in the change from time-matched baseline individual rate-corrected QTc interval or Fridericia-corrected QTc. The most common adverse events following sapanisertib 30 mg once-weekly dosing were nausea (80%), fatigue (61%), vomiting (57%), and decreased appetite (45%). A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors. The safety profile of sapanisertib 30 mg once weekly was favorable, and no new safety signals were observed (NCT02197572, clinicaltrials.gov).",2020,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"['Adult patients with advanced solid tumors', 'Patients With Advanced Solid Tumors', 'patients with advanced solid tumors']",['sapanisertib'],"['QTc interval', 'fatigue', 'safety, tolerability, and pharmacokinetics', 'sapanisertib plasma concentration', 'appetite', 'vomiting', 'nausea', 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.278022,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rangachari', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jayson D', 'Initials': 'JD', 'LastName': 'Wilbur', 'Affiliation': 'Metrum Research Group, LCC, Connecticut, USA.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'A Craig', 'Initials': 'AC', 'LastName': 'Lockhart', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.808']
1129,32585738,Non-specific analgesia during a clinical trial in fibromyalgia.,"BACKGROUND


When patients suffering from fibromyalgia undergo a therapeutic trial, a non-negligible part of analgesia is not explained by the drug itself. The mechanisms of this non-specific effect need to be understood.
MATERIALS AND METHODS


We undertook secondary analyses of a double-blind randomized trial in fibromyalgia patients in which 100 mg/day milnacipran was not found superior to placebo. Data from 49 patients belonging to both groups were pooled. Both before treatment and one month after treatment, all patients underwent a CaNTAB ®  neuropsychological test (related to spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation. We studied the baseline predictors of analgesia and the indicators of change associated to analgesia separately. A stepwise approach was used to select the factors to enter into the final ANCOVAs, in which age, body mass index, treatment group and pain at baseline were covariates.
RESULTS


No baseline predictor of non-specific analgesia other than pain at baseline was found to be predictive. Conversely, several neuropsychological (higher performance) or psychophysical (lower sensitivity) changes correlated with analgesia in unadjusted analyses. Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
CONCLUSIONS


The changes observed concomitantly to non-specific pain analgesia might be related to mild changes in brain functioning, based on convergent literature data.",2020,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
","['49 patients belonging to both groups were pooled', 'patients suffering from fibromyalgia undergo a therapeutic trial', 'fibromyalgia patients in which 100mg/day']","['milnacipran', 'placebo']","['spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1533126', 'cui_str': 'milnacipran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",49.0,0.116055,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Macian', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}]",European journal of clinical investigation,['10.1111/eci.13337']
1130,32468765,Efficacy Of Prophylactic Antibiotics In Reducing Posttonsillectomy Haemorrhage.,"BACKGROUND


This study aims toward establishing the impact of prophylactic pre-operative antimicrobial therapy on tonsillectomy related haemorrhage.
METHODS


In this randomized controlled trial conducted at Combined Military Hospital, Abbottabad from January 2017 till August 2019, 121 children and adult patients who had consented and had undergone tonsillectomy were evaluated for procedure related haemorrhage.
RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics. Patient-reported secondary haemorrhage was recorded in 4.59% (n=9) cases who did not receive pre-operative antibiotic prophylaxis, thereby increasing morbidity and prolonging hospital stay. Secondary post-operative bleeding only occurred in 1.18% (n=2) patients who received appropriate pre-operative anti-microbial prophylaxis.
CONCLUSIONS


We strongly imply that prophylactic pre-operative antibiotics reduce procedure related complications in all patients undergoing tonsillectomy.",2020,"RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics.","['Combined Military Hospital, Abbottabad from January 2017 till August 2019, 121 children and adult patients who had consented and had undergone tonsillectomy were evaluated for procedure related haemorrhage', 'patients undergoing tonsillectomy']","['Prophylactic Antibiotics', 'prophylactic pre-operative antimicrobial therapy']","['Posttonsillectomy Haemorrhage', 'morbidity and prolonging hospital stay', 'secondary haemorrhage', 'Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization', 'operative bleeding']","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0347697', 'cui_str': 'Secondary hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3267156', 'cui_str': 'Operative bleeding'}]",121.0,0.248851,"RESULTS


Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics.","[{'ForeName': 'Nadeem Ahmed', 'Initials': 'NA', 'LastName': 'Sheikh', 'Affiliation': 'Department of Otolaryngology, Combined Military Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Kanwal', 'Initials': 'K', 'LastName': 'Nadeem', 'Affiliation': 'Army Burn Hall College (For Girls), Abbottabad, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
1131,32463741,Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W.,"PURPOSE


NCI-MATCH is a nationwide, histology-agnostic, signal-finding, molecular profile-driven trial for patients with refractory cancers, lymphomas, or myelomas. Patients with tumors harboring actionable aberration(s) in fibroblast growth factor receptor ( FGFR )  1-3  were treated with AZD4547, an oral FGFR1-3 inhibitor.
METHODS


Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions. Patients were treated with AZD4547, 80 mg orally twice daily until progression of disease or drug intolerance. A response rate of 16% was considered promising.
RESULTS


Between July 2016 and June 2017, 70 patients were assigned and 48 received protocol therapy and are eligible for analysis. Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or  FGFR3  single-nucleotide variants (n = 19), or  FGFR1  or  FGFR3  fusions (n = 9). The most common primary tumors were breast (33.3%), urothelial (12.5%), and cervical cancer (10.4%).Grade 3 adverse events were consistent with those described in previous clinical trials. Confirmed partial responses were seen in 8% (90% CI, 3% to 18%) and were observed only in patients whose tumors harbored  FGFR1-3  point mutations or fusions. Stable disease was observed in 37.5% (90% CI, 25.8% to 50.4%). The median progression-free survival (PFS) was 3.4 months, and the 6-month PFS rate was 15% (90% CI, 8% to 31%). For patients with tumors harboring  FGFR  fusions, the response rate was 22% (90% CI, 4.1% to 55%), and 6-month PFS rate was 56% (90% CI, 31% to 100%).
CONCLUSION


Preliminary signals of activity appeared to be limited to cancers harboring  FGFR  activating mutations and fusions, although AZD4547 did not meet the primary end point. Different  FGFR  somatic alterations may confer different levels of signaling potency and/or oncogene dependence.",2020,FGFR3  ,"[""Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions"", 'Patients With Tumors Harboring Aberrations in the FGFR Pathway', ""Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or"", 'patients with refractory cancers, lymphomas, or myelomas', 'Patients with tumors harboring actionable aberration(s', 'Between July 2016 and June 2017, 70 patients were assigned and 48 received']","['FGFR1  or  FGFR3  fusions', 'AZD4547', 'protocol therapy', 'FGFR3', 'AZD4547, an oral FGFR1-3 inhibitor', 'fibroblast growth factor receptor']","['Stable disease', 'median progression-free survival (PFS', 'cervical cancer', '6-month PFS rate', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0527057', 'cui_str': 'FGFR3 protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C2981795', 'cui_str': 'AZD4547'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",70.0,0.037636,FGFR3  ,"[{'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Chae', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Vaklavas', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Seattle Cancer Center Alliance, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hammerman', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Zwiebel', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'S Percy', 'Initials': 'SP', 'LastName': 'Ivy', 'Affiliation': 'Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Larry V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'Center for Biomedical Informatics & Information Technology, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Conley', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Lyndsay N', 'Initials': 'LN', 'LastName': 'Harris', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02630']
1132,32464019,Comparative Evaluation of Bone Formation between PRF and Blood Clot Alone as the Sole Sinus-Filling Material in Maxillary Sinus Augmentation with the Implant as a Tent Pole: A Randomized Split-Mouth Study.,"The lack of bone volume in the posterior maxillary region can be augmented with sinus elevation. Since the elevated sinus is a closed cavity, a blood clot that fills the sinus space itself can aid in bone formation. The aim of this study was to compare bone formation in the elevated maxillary sinus between platelet-rich fibrin (PRF) and blood clot alone as the sole sinus-filling material with the implant as a tent pole. The study was a randomized controlled trial with a split-mouth design involving seven patients. An implant was placed on one side only and blood was allowed to fill the elevated sinus cavity; on the other side, PRF plugs were inserted. The sinus window was covered by nonresorbable titanium-reinforced membrane. The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor. A greater increase in distal bone height was seen in the control group. It was concluded that PRF may be more effective as a sole sinus-filling material in the elevated sinus cavity with an implant as a tent pole.",2019,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","['seven patients', 'Maxillary Sinus Augmentation with the Implant as a Tent Pole']","['PRF and Blood Clot Alone', 'PRF', 'platelet-rich fibrin (PRF) and blood clot alone']","['bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width', 'distal bone height', 'bone formation']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0337815', 'cui_str': 'Poles'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",7.0,0.0173919,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","[{'ForeName': 'Gurumoorthy', 'Initials': 'G', 'LastName': 'Kaarthikeyan', 'Affiliation': 'Department of Periodontics, Saveetha Dental College, Saveetha University, Chennai-77.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Jayakumar', 'Affiliation': 'Saveetha Dental College, Saveetha University, Chennai-77 India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sivakumar', 'Affiliation': 'Private Practitioner, Thirupur, India.'}]",Journal of long-term effects of medical implants,['10.1615/JLongTermEffMedImplants.2019031387']
1133,32470710,Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial.,"BACKGROUND


Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79).
PATIENTS AND METHODS


In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 μg/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20).
RESULTS


Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons.
CONCLUSIONS


The EORTC 18081 PEG-IFNα-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes.",2020,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","['only 112 patients were randomised, 56 in each arm', 'stage II B/C patients with ulcerated primary', 'sentinel node-negative stage II patients with an ulcerated primary melanoma', 'patients with ulcerated melanomas without palpable nodes', 'Between February 2013 and January 2017']","['adjuvant (PEG)-IFNα-2b treatment', 'pegylated interferon-alfa2b vs observation', 'pegylated (PEG)-IFNα-2b']","['distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20', '3-year RFS rate', 'DMFS', 'toxicity', '3-year DMFS rate']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.689158,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Prinses Maxima Centrum, Utrecht, the Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. Electronic address: piotr.rutkowski@pib-nio.pl.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'CHU de Bordeaux, Groupe Hospitalier Saint-André, Hopital Saint-André, Bordeaux, France. Electronic address: caroline.dutriaux@chu-bordeaux.fr.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hofman-Wellenhof', 'Affiliation': 'Medical University of Graz, Graz, Austria. Electronic address: rainer.hofmann@medunigraz.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dziewulski', 'Affiliation': 'Mid Essex Hospitals, Broomfield Hospital, Broomfield, United Kingdom. Electronic address: peter.dziewulski@meht.nhs.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ""Leeds Teaching Hospitals NHS Trust, St. James's University Hospital, Leeds, United Kingdom. Electronic address: maria.marples@nhs.net.""}, {'ForeName': 'Floren', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'CHU de Reims, Hôpital Robert Debré, Reims, France. Electronic address: fgrange@chu-reims.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lok', 'Affiliation': 'CHU Amiens, Hopital Sud, Amiens, France. Electronic address: lok.catherine@chu-amiens.fr.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Pennachioli', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy. Electronic address: elisabetta.pennacchioli@ieo.it.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif & Paris-Saclay University, Saint-Aubin, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands. Electronic address: a.v.akkooi@nki.nl.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Odense University Hospital, Odense, Denmark. Electronic address: lars.bastholt@rsyd.dk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Minisini', 'Affiliation': 'Azienda Sanitaria Universitaria Del Friuli Centrale, Udine, Italy. Electronic address: alessandro.minisini@asufc.sanita.fvg.it.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'St Helens & Knowsley NHS Trust, Whiston Hospital, Prescot, United Kingdom. Electronic address: emarshall@nhs.net.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salès', 'Affiliation': 'Institut Jules Bordet-Hopital Universitaire ULB, Brussels, Belgium. Electronic address: fsales@bordet.be.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Assistance Publique, Hopitaux de Marseille, Hôpital de La Timone (APHM), Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bechter', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium. Electronic address: oliver.bechter@uzleuven.be.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen & German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: sandrine.marreaud@eortc.org.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: michal.kicinski@eortc.org.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: stefan.suciu@eortc.org.'}, {'ForeName': 'Alessandro A E', 'Initials': 'AAE', 'LastName': 'Testori', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: A.Testori@smatteo.pv.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.015']
1134,32476236,Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease.,"BACKGROUND


Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. We investigated the effect of a colonic-delivery formulation of butyrate on the fecal microbiota of patients with inflammatory bowel diseases (IBDs).
METHODS


In this double-blind, placebo-controlled, pilot study, 49 IBD patients (n = 19 Crohn's disease, CD and n = 30 ulcerative colitis, UC) were randomized to oral administration of microencapsulated-sodium-butyrate (BLM) or placebo for 2 months, in addition to conventional therapy. Eighteen healthy volunteers (HVs) were recruited to provide a healthy microbiota model of the local people. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity and quality of life (QoL) were evaluated before and after treatment.
KEY RESULTS


At baseline, HVs showed a different microbiota composition compared with IBD patients. Sodium-butyrate altered the gut microbiota of IBD patients by increasing bacteria able to produce SCFA in UC patients (Lachnospiraceae spp.) and the butyrogenic colonic bacteria in CD patients (Butyricicoccus). In UC patients, QoL was positively affected by treatment.
CONCLUSIONS AND INFERENCES


Sodium-butyrate supplementation increases the growth of bacteria able to produce SCFA with potentially anti-inflammatory action. The clinical impact of this finding requires further investigation.",2020,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[""49 IBD patients (n\xa0=\xa019 Crohn's disease, CD and n\xa0=\xa030 ulcerative colitis, UC"", 'patients with inflammatory bowel diseases (IBDs', 'patients suffering from various colonic diseases', 'patients with inflammatory bowel disease', 'Eighteen healthy volunteers (HVs']","['Sodium-butyrate', 'microencapsulated-sodium-butyrate (BLM) or placebo', 'butyrate', 'microencapsulated sodium butyrate', 'placebo']","['Clinical disease activity and quality of life (QoL', 'QoL']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",49.0,0.0508898,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Facchin', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vitulo', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Calgaro', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Romualdi', 'Affiliation': 'Department of Biology, University of Padua, Padua, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Perini', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Lorenzon', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Marinelli', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': ""D'Incà"", 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Giacomo Carlo', 'Initials': 'GC', 'LastName': 'Sturniolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Edoardo Vincenzo', 'Initials': 'EV', 'LastName': 'Savarino', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13914']
1135,32482616,Ticagrelor alone or conventional dual antiplatelet therapy in patients with stable or acute coronary syndromes.,"AIMS


The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY).
METHODS AND RESULTS


Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only.
CONCLUSIONS


Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.",2020,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","['patients with stable or acute coronary syndromes', 'patients with or without acute coronary syndrome (ACS', '3,745 SIHD (stable ischemic heart disease', 'patients with or without ACS']","['Ticagrelor alone or conventional dual antiplatelet therapy', 'ticagrelor monotherapy', 'antiplatelet therapy (DAPT) or conventional DAPT']","['rate ratios (RR', 'rates of co-primary efficacy endpoint, composite of death, myocardial infarction, stroke or urgent target-vessel revascularization', 'ischemic endpoints', 'SIHD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]",,0.0916424,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Eugène P', 'Initials': 'EP', 'LastName': 'McFadden', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': ''}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Branca', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00145']
1136,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1137,31042420,Impact of Consensus Molecular Subtype on Survival in Patients With Metastatic Colorectal Cancer: Results From CALGB/SWOG 80405 (Alliance).,"PURPOSE


To determine the predictive and prognostic value of the consensus molecular subtypes (CMSs) of colorectal cancer (CRC) that represent a merging of gene expression-based features largely in primary tumors from six independent classification systems and provide a framework for capturing the intrinsic heterogeneity of CRC in patients enrolled in CALGB/SWOG 80405.
PATIENTS AND METHODS


CALGB/SWOG 80405 is a phase III trial that compared the addition of bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan as first-line treatment of advanced CRC. We characterized the CMS classification using a novel NanoString gene expression panel on primary CRCs from 581 patients enrolled in this study to assess the prognostic and predictive value of CMSs in these patients.
RESULTS


The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001). Furthermore, CMSs were predictive for both OS ( P  for interaction < .001) and PFS ( P  for interaction = .0032). In the CMS1 cohort, patients treated with bevacizumab had a significantly longer OS than those treated with cetuximab ( P  < .001). In the CMS2 cohort, patients treated with cetuximab had a significantly longer OS than patients treated with bevacizumab ( P  = .0046).
CONCLUSION


These findings highlight the possible clinical utility of CMSs and suggests that refinement of the CMS classification may provide a path toward identifying patients with metastatic CRC who are most likely to benefit from specific targeted therapy as part of the initial treatment.",2019,The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001).,"['581 patients enrolled', 'patients with metastatic CRC', 'advanced CRC', 'Patients With Metastatic Colorectal Cancer']","['cetuximab', 'bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan', 'bevacizumab']","['longer OS', 'PFS', 'progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",581.0,0.0554368,The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001).,"[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': '1University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': '3University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': '4Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': '5Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': '6West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': '7Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""8Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': '9Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': '10Genentech, San Francisco, CA.'}, {'ForeName': 'Pratyaksha', 'Initials': 'P', 'LastName': 'Wirapati', 'Affiliation': '11Swiss Institute of Bioinformatics, Lausanne, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': '12Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': '13The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kabbarah', 'Affiliation': '10Genentech, San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02258']
1138,32488263,Efficacy and Safety of Two Fixed-Dose Combinations of Tramadol Hydrochloride and Diclofenac Sodium in Postoperative Dental Pain.,"OBJECTIVE


To evaluate the analgesic efficacy and safety of tramadol hydrochloride/diclofenac sodium fixed-dose combination 25 mg/25 mg (FDC 25/25) and 50 mg/50 mg (FDC 50/50) vs tramadol 50 mg (T50) and diclofenac 50 mg (D50) monotherapies in acute postoperative dental pain.
SETTING


Eight sites across Mexico.
SUBJECTS


Adults (N = 829) with moderate to severe pain after third molar extraction.
DESIGN


Prospective, randomized, double-blind, diclofenac- and tramadol-controlled, parallel-group, noninferiority, phase 3 trial.
METHODS


Subjects were randomized to receive three doses (one every eight hours) of oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period. Pain intensity and pain relief were evaluated frequently over the 24 hours postdose. Secondary measures included peak pain relief, onset, and duration of effect. The primary objective was to compare the analgesic efficacy and safety of FDC 50/50 or analgesic noninferiority of FDC 25/25 vs D50 or T50. The primary efficacy end point was total pain relief over four hours after dose 1 (TOTPAR4).
RESULTS


TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components. All secondary efficacy measures supported these results. The safety profile of FDC 25/25 and FDC 50/50 was consistent with the known safety profile of D50 and T50 monotherapies, with no unexpected safety findings observed.
CONCLUSIONS


Tramadol/diclofenac FDC 25/25 and FDC 50/50 provide superior analgesia for acute pain after third molar extraction than either of the individual components. Minor adverse effects appeared to be related to the higher doses of tramadol.",2020,"RESULTS


TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","['acute postoperative dental pain', 'Adults (N\u2009=\u2009829) with moderate to severe pain after third molar extraction', 'Subjects', 'Eight sites across Mexico']","['tramadol 50\u2009mg (T50) and diclofenac 50\u2009mg (D50) monotherapies', 'oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period', 'diclofenac- and tramadol', 'tramadol hydrochloride/diclofenac sodium fixed-dose combination 25\u2009mg/25\u2009mg (FDC 25/25) and 50\u2009mg/50\u2009mg (FDC 50/50', 'FDC', 'tramadol', 'Tramadol/diclofenac FDC', 'Tramadol Hydrochloride and Diclofenac Sodium']","['Postoperative Dental Pain', 'Efficacy and Safety', 'Pain intensity and pain relief', 'analgesic efficacy and safety', 'peak pain relief, onset, and duration of effect', 'TOTPAR4 scores', 'total pain relief']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C2350089', 'cui_str': 'Tramadol hydrochloride'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",829.0,0.338081,"RESULTS


TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Desjardins', 'Affiliation': 'Desjardins Associates, LLC, Maplewood, New Jersey.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Alvarado', 'Affiliation': 'ECI-Estudios Clínicos Internacionales, Puebla, México.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Gil', 'Affiliation': 'Eukarya Pharmasite S.C., Monterrey, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Instituto de Investigación del Hospital Cardiológica, Aguascalientes, México.'}, {'ForeName': 'Rogelio', 'Initials': 'R', 'LastName': 'Guajardo', 'Affiliation': 'Centro de Investigación Farmacológica del Bajío, S.C., León, Guanajuato, México.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa124']
1139,32585670,Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study.,"INTRODUCTION


Control of hyperphosphatemia in patients on dialysis remains a major challenge.
OBJECTIVE


This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial.
METHODS


Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled.
RESULTS


Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (-2.89 vs. -0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765-0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328-0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937-0.992) as significant predictors of uncontrolled sP.
CONCLUSION


This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.",2020,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","['younger patients with high sP levels', 'patients with hyperphosphatemia who received 52 weeks of treatment with', 'dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial', 'Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52']","['Sevelamer Carbonate', 'sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer']","['Baseline sP levels', 'chronic kidney disease-mineral-bone disorder parameters', 'higher body mass index', 'sP reductions']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}, {'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0718050', 'cui_str': 'sevelamer'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",302.0,0.0379352,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","[{'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Covic', 'Affiliation': 'Nephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Iași, Romania, accovic@gmail.com.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ketteler', 'Affiliation': 'Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Walpen', 'Affiliation': 'Department of Medical Affairs, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Department of Biometrics, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology, RWTH University Hospital Aachen, Aachen, Germany.'}]",Nephron,['10.1159/000507258']
1140,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND


Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS


A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS


When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
1141,32592369,Neoadjuvant FOLFIRINOX followed by Chemoradiotherapy for Middle and Lower Rectal Cancer.,"OBJECTIVE


Neoadjuvant concomitant chemoradiotherapy followed by surgical resection is the standard of care in the treatment of rectal cancer. We are investigating the value of adding combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy.
METHODS


Forty-one patients with middle and lower rectal cancer were included. FOLFORINOX were given every 2 weeks over 2 months (4 cycles) followed by concomitant chemoradiotherapy (CRT). Surgery was done 6-8 weeks after CRT and then adjuvant 4 months of FOLFOX or XELOX were given. The primary end point was sphincter preservation rate.
RESULTS


All patients received the four cycles of neoadjuvant chemotherapy FOLFORINOX, 38 patients completed CRT and only 29 patients underwent surgery. 32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy). Sphincter preservation was achieved in twenty-one patients (51.2%). Pathological complete response rate was 24.1%. After a median follow up of 24 months. Median PFS was 20 months and 2-years PFS was 62.3%. The median overall survival of all patients was not reached, while 2-years OS was 76.5%.
CONCLUSION


Neoadjuvant FOLFIRINOX followed by CRT for middle and lower rectal cancer is feasible, tolerable with satisfactory sphincter preservation rate. <br />.",2020,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%.
","['38 patients completed CRT and only 29 patients underwent surgery', '32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy', 'Forty-one patients with middle and lower rectal cancer were included', 'Middle and Lower Rectal Cancer', 'rectal cancer']","['Neoadjuvant concomitant chemoradiotherapy', 'combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy', 'FOLFOX or XELOX', 'concomitant chemoradiotherapy (CRT', 'neoadjuvant chemotherapy']","['Median PFS', 'Pathological complete response rate', 'sphincter preservation rate', 'median overall survival', 'Sphincter preservation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",41.0,0.0860488,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%.
","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'Elsherbiny', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Abdel Moneim', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shaaban', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Aldaly', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1717']
1142,32592381,Randomized Pilot Study of 20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy for Treating Painful Bone Metastases: A Single Institution Experience.,"PURPOSE


Radiotherapy is a very effective tool in the treatment of painful bone metastases. The aim of this study was to compare the palliative effect of radiotherapy between the standard fractionation schedule 20 Gy over 5 fractions (20Gy/5fr) and the high biological dose schedule 27 Gy over 3 fractions (27Gy/3fr) which is frequently used in Stereotactic body radio-surgery (SBRT).
METHODS


Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr). The primary aim of the study was pain relief using the numeric rating scale (NRS), after three months of radiation therapy. Secondary end points include pain relief immediately after finishing radiation therapy (within one week), and narcotic relief after three months of radiation therapy.
RESULTS


Twenty-two patients with painful bone metastases were included. 12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr). Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years]. For pain relief after three months of radiation therapy, partial pain relief was documented in 9 patients (75%) with (20Gy/5fr) and in 8 patients (80%) with (27Gy/3fr) with a p- value of 0.6. Additionally, narcotic relief after three months was equal for both groups. For immediate pain relief, partial pain relief was seen in one patient (8%) with (20Gy/5fr) versus seven patients (70%) with (27Gy/3fr) with a p value of 0.06. The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant.
CONCLUSION


SBRT and standard fractionation radiation therapy had equal effectiveness for pain relief, when the assessment was done after three months of radiation therapy. Interestingly, SBRT had a better immediate pain relief. <br />.",2020,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant.
","['Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years', '12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr', 'painful bone metastases', 'Twenty-two patients with painful bone metastases', 'Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr']","['radiotherapy', '20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy', 'SBRT and standard fractionation radiation therapy', 'SBRT', 'Radiotherapy']","['partial pain relief', 'pain relief', 'immediate pain relief', 'pain relief using the numeric rating scale (NRS', 'narcotic relief', 'immediate pain relief, partial pain relief']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",22.0,0.0383319,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant.
","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Wedad Bassam', 'Initials': 'WB', 'LastName': 'Hashem', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Karim Nabil', 'Initials': 'KN', 'LastName': 'Mashhour', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1807']
1143,32592382,Effect of a Pedometer-based Exercise Program on Cancer Related Fatigue and Quality of Life amongst Patients with Breast Cancer Receiving Chemotherapy.,"BACKGROUND


Breast cancer is the most common cancer amongst Indian women. Cancer treatments leads to various side effects out of which Cancer-Related fatigue (CRF) is one of the most under-addressed side-effects. It is experienced the most in patients receiving chemotherapy. Exercise has been proven to be a beneficial intervention to manage CRF but the benefits of pedometer-based exercise programs is under-studied in patients with breast cancer. Hence, we set out to investigate the effects of a pedometer-based exercise program for patients with breast receiving chemotherapy.
METHODS


The current study was a non-randomized controlled trial with 22 patients each in exercise and control group. The exercise group received a pedometer-based walking program, whereas the control group received standard physical activity advice. Fatigue, quality of life, functional capacity and body composition were assessed at baseline, 3rd week and 7th week.
RESULTS


At the end of 7 weeks intervention, functional capacity, quality of life and skeletal mass were found to have improved with statistical significance, while the fatigue and changes in total fat did improve but were not statistically significant.
CONCLUSION


A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.",2020,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","['patients with breast receiving chemotherapy', 'Indian women', 'Patients with Breast Cancer', '22 patients each in exercise and control group', 'patients with breast cancer', 'patients receiving chemotherapy', 'patients with breast cancer receiving chemotherapy']","['pedometer-based walking program, whereas the control group received standard physical activity advice', 'Pedometer-based Exercise Program', 'Chemotherapy', 'pedometer-based exercise program']","['Cancer Related Fatigue and Quality of Life', 'Fatigue, quality of life, functional capacity and body composition', 'functional capacity, quality of life and skeletal mass', 'functional capacity, quality of life and percentage of skeletal mass', 'fatigue and changes in total fat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",22.0,0.0245141,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","[{'ForeName': 'Aagna', 'Initials': 'A', 'LastName': 'Gandhi', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Stephen Rajan', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'K Vijaya', 'Initials': 'KV', 'LastName': 'Kumar', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Pu Prakash', 'Initials': 'PP', 'LastName': 'Saxena', 'Affiliation': 'Department of Radiation oncology, Kasturba Medical College, Manipal Academy of Higher education, Mangalore, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Mithra', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1813']
1144,32464280,"Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial.","BACKGROUND


There is a high unmet clinical need for treatments of advanced/metastatic biliary tract cancers after progression on first-line chemotherapy. Regorafenib has demonstrated efficacy in some gastrointestinal tumors that progress on standard therapies.
PATIENTS AND METHODS


REACHIN was a multicenter, double-blind, placebo-controlled, randomized phase II study designed to evaluate the safety and efficacy of regorafenib in patients with nonresectable/metastatic biliary tract cancer that progressed after gemcitabine/platinum chemotherapy. Patients were randomly assigned 1 : 1 to best supportive care plus either regorafenib 160 mg once daily 3 weeks on/1 week off or placebo until progression or unacceptable toxicity. No crossover was allowed. The primary objective was progression-free survival (PFS). Secondary objectives were response rate, overall survival, and translational analysis.
RESULTS


Sixty-six patients with intrahepatic (n = 42), perihilar (n = 6), or extrahepatic (n = 9) cholangiocarcinoma, or gallbladder carcinoma (n = 9) were randomized, 33 to each treatment group (33 per group). At a median follow-up of 24 months, all patients had progressed and six patients were alive. Median treatment duration was 11.0 weeks [95% confidence interval (CI): 6.0-15.9] in the regorafenib group and 6.3 weeks (95% CI: 3.9-7.0) in the placebo group (P = 0.002). Fourteen of 33 patients (42%) in the regorafenib group had a dose reduction. Stable disease rates were 74% (95% CI: 59-90) in the regorafenib group and 34% with placebo (95% CI: 18-51; P = 0.002). Median PFS in the regorafenib group was 3.0 months (95% CI: 2.3-4.9) and 1.5 months (95% CI: 1.2-2.0) in the placebo group (hazard ratio 0.49; 95% CI: 0.29-0.81; P = 0.004) and median overall survival was 5.3 months (95% CI: 2.7-10.5) and 5.1 months (95% CI: 3.0-6.4), respectively (P = 0.28). There were no unexpected/new safety signals.
CONCLUSION


Regorafenib significantly improved PFS and tumor control in patients with previously treated metastatic/unresectable biliary tract cancer in the second- or third-line setting.
CLINICAL TRIAL REGISTRATION


The trial is registered in the European Clinical Trials Register database (EudraCT 2012-005626-30) and at ClinicalTrials.gov (NCT02162914).",2020,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"['advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy', 'patients with previously treated metastatic/unresectable BTC in the second- or third-line setting', 'locally advanced/metastatic biliary tumors', 'patients with nonresectable/metastatic BTC that progressed after', 'Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9']","['regorafenib', 'supportive care plus either regorafenib', 'Regorafenib', 'gemcitabine/platinum chemotherapy', 'gemcitabine and platinum-based chemotherapy', 'placebo']","['PFS and tumor control', 'Median PFS', 'median OS', 'Stable disease rates', 'Median treatment duration', 'safety and efficacy', 'progression-free survival (PFS', 'response rate, overall survival (OS), and translational analysis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005426', 'cui_str': 'Neoplasm of biliary tract'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",66.0,0.690482,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demols', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: anne.demols@erasme.ulb.ac.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Eynde', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': 'Oncology Department, Saint-Joseph Community Health Center, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Oncology Department - University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marechal', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': 'GE Department, INDC Entité Jolimontoise, Haine-St-Paul, Belgium.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Goemine', 'Affiliation': 'Oncology Department, Cliniques et Maternité Ste Elisabeth, Namur, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'GE Department - Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holbrechts', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire A. Paré, Mons, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paesmans', 'Affiliation': 'Data Center, Institut J. Bordet, Brussels, Belgium.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.018']
1145,32472958,"Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial .","Rebound pain after brachial plexus block resolution and development of long-lasting pain are problems associated with volar plate fixation for distal radius fractures. The aim of this double-blind study was to evaluate the effect of a single prophylactic intravenous dose of dexamethasone in this setting. The primary endpoint was highest pain score during the first 24 hours after surgery. We included 51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius. All received premedication with oral paracetamol and etoricoxib, and a pre-operative brachial plexus block with ropivacaine. Patients were randomly allocated into two groups: a dexamethasone group receiving 16 mg dexamethasone intravenously at start of surgery and a control group receiving 4 ml saline. After surgery, all patients received fixed doses of paracetamol, etoricoxib and oxycodone, with further oxycodone added as needed in the first 48 hours. Pain, analgesic consumption and daily function were registered at predefined times up to 1 year after surgery. Median (IQR [range]) worst pain score in the first 24 hours, as assessed by verbal numeric rating scale (0-10), was 4 (2-6 [0-7]) in the dexamethasone group compared with 8 (5-8 [2-10]) in the placebo group (p < 0.001). Average pain score, 2 (1-4 [0-5]) vs. 5 (3-6 [0-8]), p = 0.001 and rescue oxycodone consumption, 5 (0-10 [0-35]) mg vs. 10 (5-15 [0-50]) mg, p = 0.037), respectively, were both significantly lower in the dexamethasone group compared with control from 8 to 24 hours. Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6]) hours, p < 0.001. Two patients (9%) in the dexamethasone group compared with 12 (50%) in the placebo group experienced worst pain scores of 8-10 during the first 36 hours (p = 0.002). At 3 and 7 days postoperatively, there were no significant differences between groups for pain scores or opioid consumption. At 6 months, 27 patients (57%) reported pain at the site of surgery, with significantly higher average pain score (p = 0.024) in the placebo group. At 1 year, two patients in the dexamethasone group reported pain compared with 10 in the placebo group (p = 0.015), and worst pain score was significantly higher in the placebo group (p = 0.018). We conclude that intravenous dexamethasone improves early postoperative analgesia and may also improve clinical outcomes after 6 and 12 months.",2020,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","['distal radius fracture with brachial plexus block anaesthesia', '51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius']","['volar plate fixation', 'dexamethasone group receiving 16\xa0mg dexamethasone', 'dexamethasone', 'volar plate surgery', 'ropivacaine', 'control group receiving 4\xa0ml saline', 'intravenous dexamethasone', 'paracetamol, etoricoxib and oxycodone, with further oxycodone', 'oral paracetamol and etoricoxib', 'placebo']","['Pain, analgesic consumption and daily function', 'Analgesic effect', 'early postoperative analgesia', 'verbal numeric rating scale', 'clinical outcomes', 'worst pain scores', 'highest pain score', 'average pain score', 'Brachial plexus block duration', 'Rebound pain', 'Median (IQR [range]) worst pain score', 'pain scores or opioid consumption', 'pain', 'worst pain score', 'Average pain score']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",51.0,0.547037,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holmberg', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Hassellund', 'Affiliation': 'Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Draegni', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nordby', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Ottesen', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gulestøl', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raeder', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}]",Anaesthesia,['10.1111/anae.15111']
1146,32474156,Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis.,"BACKGROUND


Comorbid perennial allergic rhinitis (PAR) or year-round aeroallergen sensitivity substantially contributes to disease burden in patients with asthma. Dupilumab blocks the shared receptor for interleukin (IL) 4 and IL-13, key drivers of type 2 inflammation that play important roles in asthma and PAR. In the LIBERTY ASTHMA QUEST trial (NCT02414854), dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV 1 ) in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline (blood eosinophils and fractional exhaled nitric oxide).
OBJECTIVE


To assess dupilumab efficacy in LIBERTY ASTHMA QUEST patients with comorbid PAR.
METHODS


Severe asthma exacerbation rates, FEV 1 , asthma control (5-item Asthma Control Questionnaire), rhinoconjunctivitis-specific health-related quality of life (Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores), and type 2 inflammatory biomarkers during the 52-week treatment period were assessed.
RESULTS


A total of 814 of the 1902 patients (42.8%) had comorbid PAR (defined as an allergic rhinitis history and ≥1 perennial aeroallergen specific immunoglobulin E (IgE) level ≥0.35 kU/L at baseline). Dupilumab, 200 and 300 mg every 2 weeks, vs placebo reduced severe exacerbations rates by 32.2% and 34.6% (P < .05 for both) and improved FEV 1  at week 12 by 0.14 L and 0.18 L (P < .01 for both); greater efficacy was observed in patients with elevated baseline blood eosinophil counts (≥300 cells/μL) and fractional exhaled nitric oxide. Dupilumab treatment also numerically improved the 5-item Asthma Control Questionnaire and Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores and suppressed type 2 inflammatory biomarkers.
CONCLUSION


Dupilumab improved key asthma-related outcomes, asthma control, and rhinoconjunctivitis-specific health-related quality of life while suppressing type 2 inflammatory biomarkers and perennial allergen-specific IgE in patients with moderate-to-severe asthma and comorbid PAR, highlighting its dual inhibitory effects on IL-4 and IL-13 and its role in managing asthma and PAR.",2020,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","['asthma patients', 'patients with asthma and perennial allergic rhinitis', 'patients with moderate-to-severe asthma and comorbid PAR', 'patients had comorbid PAR', 'QUEST patients with comorbid PAR (allergic rhinitis history and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline']","['Dupilumab', 'placebo']","['Severe asthma exacerbation rates, FEV1, asthma control (ACQ-5), rhinoconjunctivitis-specific health-related quality of life (HRQoL) (RQLQ[S]+12), and type 2 inflammatory biomarkers', 'forced expiratory volume', 'ACQ-5 and RQLQ(s)+12 scores, and suppressed type 2 inflammatory biomarkers', 'severe exacerbations rates', 'FEV1', 'dupilumab efficacy', 'efficacy']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0837837,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Texas Medical Center, Houston, Texas.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, California.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital and Western Sydney University, Campbelltown, Australia.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'The University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'Asthma and Allergy Center, Bellevue, Nebraska.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.026']
1147,32476057,The impact of employment on recovery among individuals who are homeless with severe mental illness in the Vancouver At Home/Chez Soi trial.,"OBJECTIVE


To assess impact of employment on recovery in a sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders.
METHODS


The VAH included two randomized controlled trials investigating the effect of housing first with support intervention in vulnerable population. Employment was assessed at baseline and during the follow-up using Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires, respectively. Recovery was examined using Recovery Assessment Scale (RAS) at baseline and at 24-month follow-up visit. Multivariable regression models were built to examine: (1) the effect of current employment at baseline on RAS score at baseline, and RAS score at 24-month follow-up visit; and (2) and to examine the cumulative effect of recent employment over 8 follow-up visits on RAS score at 24-month visit. Cumulative effect of employment over the follow-up visits was weighted by recency using a pre-specified weighting function.
RESULTS


Employment at baseline was associated with an increase in recovery score at baseline [8.06 (95% CI 1.21, 14.91); p = 0.02], but not with recovery score at 24-month follow-up visit [3.78 (-4.67, 12.24); p = 0.37]. Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
CONCLUSION


Employment is associated with an increase in recovery. Our result suggests a dual effect of employment on recovery, an immediate effect through current employment, and a long-term effect of cumulative employment.",2020,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","['sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders', 'individuals who are homeless with severe mental illness in the Vancouver', 'vulnerable population']",['housing first with support intervention'],"['recovery score', 'recovery', 'RAS score at baseline, and RAS score', 'Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires', 'Recovery Assessment Scale (RAS', 'RAS score']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.178522,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Yazdani', 'Affiliation': 'Addiction and Concurrent Disorders Group, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada. kia_yzd@yahoo.com.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nikoo', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sayre', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Choi', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Reinhard Michael', 'Initials': 'RM', 'LastName': 'Krausz', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01887-9']
1148,32487336,Echinacea can help with Azithromycin in prevention of recurrent tonsillitis in children.,"PURPOSE


Recurrent tonsillitis in children is a common disease affecting children quality of life and extends to their families. The aim of this study was to assess the effect of combined use of oral Azithromycin (AZT) plus Echinacea compared to exclusive use of AZT in children with recurrent tonsillitis.
MATERIAL AND METHODS


A prospective comparative study including three groups of children with recurrent tonsillitis. Group 1: (100 patients) had no prophylactic treatment. Group 2 (100 patients) received [60 mg/kg] prophylactic dose of AZT divided as (10 mg/kg/day) over 6 consecutive days every month for 6 consecutive months. Group 3 (100 patients) received AZT as in group 2 plus commercially available Echinacea in a dose of 5 ml oral suspension; 3 times daily for 10 consecutive days every month for 6 consecutive months. Number of tonsillitis attacks and severity of tonsillitis symptoms were assessed and compared in different groups.
RESULTS


Group 2 and group 3 had significant less number of tonsillitis attacks and severity of assessed symptoms during 6 months of prophylactic treatment with significant better results in group 3 (i.e. AZT plus Echinacea) compared to group 2 (I.e. AZT alone). However; there was no significant difference in patients with any prophylaxis.
CONCLUSION


The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.",2020,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"['pediatric patients with recurrent tonsillitis', 'children with recurrent tonsillitis', 'children']","['AZT as in group 2 plus commercially available Echinacea in a dose of 5\u202fml oral suspension', 'Azithromycin', 'AZT', 'oral Azithromycin (AZT) plus Echinacea']","['Number of tonsillitis attacks and severity of tonsillitis symptoms', 'tonsillitis attacks and severity of assessed symptoms']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740402', 'cui_str': 'Tonsillitis recurrent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0752270', 'cui_str': 'Echinacea Preparation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0177451,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"[{'ForeName': 'Osama G', 'Initials': 'OG', 'LastName': 'Abdel-Naby Awad', 'Affiliation': 'Otolaryngology, Head and Neck Department, Minia University Hospital, 122 Kornish El-Neel Street, Minia City, Minia, Egypt. Electronic address: Usama.abdelnabi@mu.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2019.102344']
1149,32580579,Infigratinib in patients with advanced cholangiocarcinoma with  FGFR2  gene fusions/translocations: the PROOF 301 trial.,"Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain  FGFR  alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic  FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with  FGFR2  translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients. Clinical Trial Registration: NCT03773302 (ClincalTrials.gov).",2020,Favorable results from a Phase II trial of infigratinib in advanced/metastatic  FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting.,"['advanced/metastatic cholangiocarcinoma with  FGFR2  translocations', 'patients with advanced cholangiocarcinoma with  FGFR2  gene fusions/translocations']",['care gemcitabine and cisplatin'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087471', 'cui_str': 'Cholangiocarcinoma metastatic'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0178648', 'cui_str': 'Gene Fusion'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.0744824,Favorable results from a Phase II trial of infigratinib in advanced/metastatic  FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting.,"[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Makawita', 'Affiliation': 'Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'K Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Sameek', 'Initials': 'S', 'LastName': 'Roychowdhury', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, The James Cancer Hospital & Comprehensive Cancer Center, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, CA 90404, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'Department of Gastroenterology & Digestive Oncology, Cliniques Universitaires Saint-Luc & Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center & US Oncology Research, Denver, CO 80218, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamarca', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Division of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology & IOB quirón, Barcelona, Spain.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'T Shroff', 'Affiliation': 'Division of Hematology/Oncology, University of Arizona Cancer Center, Tucson, AZ 85724, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Howland', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Cho', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Pande', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, TX 77030, USA.'}]","Future oncology (London, England)",['10.2217/fon-2020-0299']
1150,32597565,Sequential nephron blockade with combined diuretics improves diastolic function in patients with resistant hypertension.,"AIMS


Hypertension is a major contributor to cardiac diastolic dysfunction. Different therapeutics strategies have been proposed to control blood pressure (BP), but their independent impact on cardiac function remains undetermined. In patients with resistant hypertension, we compared the changes in cardiac parameters between two strategies based on sequential nephron blockade (NBD) with a combination of diuretics or sequential renin-angiotensin system blockade (RASB).
METHODS AND RESULTS


After a 4-week period where all patients received Irbesartan 300 mg/day + hydrochlorothiazide 12.5 mg/day + amlodipine 5 mg/day, 140 resistant hypertension patients (54.8 ± 11.1 years, 76% men, mean duration with hypertension: 13.1 ± 10.5 years, no previous history of heart failure or current symptoms of congestive heart failure) were randomized 1:1 to the NBD regimen or to the RASB regimen at week 0 (W0, baseline). Treatment intensity was increased at week 4, 8, or 10 if home BP was ≥135/85 mmHg, by sequentially adding 25 mg spironolactone, 20-40 mg furosemide, and 5 mg amiloride (NBD group) or 5-10 mg ramipril and 5-10 mg bisoprolol (RASB group). No other antihypertensive drug was allowed during the study. BP, BNP levels, and echocardiographic parameters were assessed at weeks 0 and 12. The baseline characteristics, laboratory parameters, and plasma hormones (BNP, renin, and aldosterone) and cardiac echocardiographic parameters did not significantly differ between the NBD and the RASB groups. Over 12 weeks, BNP levels significantly decreased in NBD but increased in RASB (mean [CI 95%] change in log-transformed BNP levels: -43% [-67%; -23%] vs. +55% [46%; 62%] in NBD vs. RASB, respectively, P < 0.0001). Similarly, the proportion of patients presenting ≥2 echocardiographic criteria of diastolic dysfunction decreased between baseline and W12 from 31% to 3% in NBD but increased from 19% to 32% in RASB (P = 0.0048). As compared with RASB, NBD induced greater decrease in ambulatory systolic BP (P < 0.0001), pulse pressure (P < 0.0001), and systemic vascular resistance (P < 0.005). In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P < 0.0001) independent of age, gender, renal function, and changes in BPs or heart rate.
CONCLUSIONS


In patients with resistant hypertension, nephron blockade with a combination of diuretics significantly improves cardiac markers of diastolic dysfunction independently of BP lowering.",2020,"In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P ","['140 resistant hypertension patients (54.8\xa0±\xa011.1\xa0years, 76% men, mean duration with hypertension: 13.1\xa0±\xa010.5\xa0years, no previous history of heart failure or current symptoms of congestive heart failure', 'patients with resistant hypertension, nephron blockade with a combination of', 'patients with resistant hypertension']","['spironolactone', 'Irbesartan 300\xa0mg/day\xa0+\xa0hydrochlorothiazide 12.5\xa0mg/day\xa0+\xa0amlodipine', 'furosemide, and 5\xa0mg amiloride (NBD group) or 5-10\xa0mg ramipril', 'diuretics', 'diuretics or sequential renin-angiotensin system blockade (RASB', 'RASB, NBD', 'combined diuretics']","['BP, BNP levels, and echocardiographic parameters', 'BNP levels', 'RASB', 'pulse pressure', 'age, gender, renal function, and changes in BPs or heart rate', 'proportion of patients presenting ≥2 echocardiographic criteria of diastolic dysfunction', 'systemic vascular resistance', 'baseline characteristics, laboratory parameters, and plasma hormones (BNP, renin, and aldosterone) and cardiac echocardiographic parameters', 'cardiac markers of diastolic dysfunction', 'control blood pressure (BP', 'diastolic function', 'ambulatory systolic BP']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027713', 'cui_str': 'Nephron structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0986850', 'cui_str': 'irbesartan 300 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0986524', 'cui_str': 'Hydrochlorothiazide 12.5 MG'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0027713', 'cui_str': 'Nephron structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0396228,"In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fouassier', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Blanchard', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Fayol', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bobrie', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Hypertension unit, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boutouyrie', 'Affiliation': 'Paris Cardiovascular Research Center PARCC, INSERM, Université de Paris, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Azizi', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Hulot', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}]",ESC heart failure,['10.1002/ehf2.12832']
1151,32602000,Contrast-enhanced ultrasonography and blue dye methods in detection of sentinel lymph nodes following neoadjuvant chemotherapy in initially node positive breast cancer.,"BACKGROUND


Recent studies show that contrast-enhanced ultrasonography (CEUS) using SonoVue has the potential to improve the performance of sentinel lymph node biopsy (SLNB) in patients with early breast cancer. However, the evidence of SLNB using CEUS in patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC) is lacking. The aim of this prospective study is to evaluate the feasibility of CEUS using SonoVue for the identification of sentinel lymph node (SLN) and the value of the combination of CEUS and blue dye (BD) for SLNB in patients converting from cN1 to cN0 following NAC.
METHODS


Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC. Patients converting from cN1 to cN0 following NAC were enrolled and randomized into two groups for SLNB: the combination method group using CEUS and BD together, and the single BD method group. Then all patients underwent complete axillary lymph node dissection (ALND) and primary breast surgery. Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
RESULTS


A total of 400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5%) patients had clinically negative node confirmed by imaging after NAC and randomized into two groups. Each group included 67 cases. In the combination method group, contrast-enhanced lymphatic vessels in 66 cases of 67 were clearly visualized by US soon after the periareolar injection of SonoVue and the SLNs were accurately localized. The identification rate of the combination method was 98.5%%, which was significantly higher than 83.6% (56/67) using the single BD method. The mean numbers of SLNs identified by the combination method was higher than that by the single BD method. Compared with pathological diagnosis, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method were 84.4%, 100%, 89.4%, 100%, 75%, and 15.6%, respectively. In contrast, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR using single blue dye were 73.9%, 100%, 89.3%, 100%, 84.6%, and 26.1%, respectively. The FNR using the combination method was significantly lower than that using single BD.
CONCLUSION


Identification of SLNs in patients converting from cN1 to cN0 following NAC by CEUS is a technically feasible. The combination of CEUS and BD is more effective than BD alone for SLNB in patients converting from cN1 to cN0 following NAC.",2020,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","['initially node positive breast cancer', '400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5', 'Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC', 'patients converting from cN1 to cN0 following NAC', 'Patients converting from cN1 to cN0 following NAC', 'patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC', 'patients with early breast cancer']","['SLNB: the combination method group using CEUS', 'CEUS', 'CEUS and BD', 'CEUS and blue dye (BD', 'complete axillary lymph node dissection (ALND) and primary breast surgery', 'Contrast-enhanced ultrasonography and blue dye methods', 'neoadjuvant chemotherapy', 'contrast-enhanced ultrasonography (CEUS']","['identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value', 'mean numbers of SLNs', 'sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method', 'sensitivity, specificity, accuracy, the positive predictive value']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",400.0,0.0388999,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","[{'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Breast Surgical Oncology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, No. 420 Fuma Road, Fuzhou, 350014, Fujian, People's Republic of China. wxf200104@hotmail.com.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Shixin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': ""Department of Clinical Laboratory, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Pathology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05646-8']
1152,32603494,Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.,"OBJECTIVE


Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD).
DESIGN


Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
PATIENTS


Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
MEASUREMENTS


Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT).
RESULTS


Mean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH. Rate of AEs per 100 patient-years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment-related. Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]: -1.74 [-18.13; 14.66], -11.53 [-35.54; 12.48] and - 12.85 [-47.31; 21.62] cm 2  , respectively).
CONCLUSIONS


Treatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar to somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available at https://bit.ly/3946YNF.",2020,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","['Patients Previously GH-treated Japanese patients with AGHD', 'Japanese patients with adult growth hormone deficiency (AGHD', 'previously treated adults with growth hormone deficiency', 'patients with AGHD', '21.62']","['once-weekly somapacitan versus daily GH', 'somapacitan or daily growth hormone', 'daily GH', 'somapacitan']","['I standard deviation score (IGF-I SDS', 'VAT, SAT or TAT', 'adipose tissue', 'change from baseline to week\xa052 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT', 'safety and efficacy', 'incidence of adverse events (AEs', 'Mean insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1720505', 'cui_str': 'Adult growth hormone deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",,0.297851,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","[{'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Otsuka', 'Affiliation': 'Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tahara', 'Affiliation': 'Department of Neurosurgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'CMR Development Division, Novo Nordisk Pharma Ltd., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Højby Rasmussen', 'Affiliation': 'Global Development, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Kitasato University, Sagamihara, Japan.'}]",Clinical endocrinology,['10.1111/cen.14273']
1153,32445440,Remdesivir for the Treatment of Covid-19 - Final Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).
CONCLUSIONS


Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1154,32478917,Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.,"BACKGROUND


Palliative care remains suboptimal in end-stage liver disease.
AIM


To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.
METHODS


A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.
RESULTS


Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.
CONCLUSIONS


The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.
TRIAL REGISTRATION


ISRCTN30697116, date assigned: 07/10/2015.",2020,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"['59 eligible patients, 36 (61']","['palliative long-term abdominal drains vs large-volume paracentesis', 'large-volume paracentesis vs long-term abdominal drains']","['Total attrition', 'peritonitis incidence', 'serum creatinine', 'Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital', 'Self-limiting cellulitis/leakage', 'median number (IQR) of hospital ascitic drains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439685', 'cui_str': 'Ascitic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",59.0,0.162379,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macken', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Steer', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parnell', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Thomson', 'Affiliation': 'Worthing, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Isaacs', 'Affiliation': 'Blackpool, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hashim', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15802']
1155,32476617,Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up.,"Background . Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke.  Objective . To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9).  Methods . All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log.  Results . There were no VNS treatment-related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7;  P  = .001; n = 15). Other functional measures were also improved at 1 year.  Conclusions . VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",2020,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",['After Stroke'],"['clinic therapy with Control or Active VNS followed by home exercises through day 90', 'rehabilitation therapy paired with Active VNS (n = 8) or Control VNS', 'Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation', 'home exercise program paired with VNS', 'individualized home exercise program with self-administered Active VNS', 'VNS combined with rehabilitation', 'Vagus nerve stimulation (VNS) paired with rehabilitation']","['Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log', 'FMA-UE score', 'VNS treatment-related serious adverse events']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.123532,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Navzer D', 'Initials': 'ND', 'LastName': 'Engineer', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Cecília N', 'Initials': 'CN', 'LastName': 'Prudente', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pierce', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Francisco', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Yozbatiran', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Tarver', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Casavant', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Kline', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Cramer', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van de Winckel', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320924361']
1156,32476619,Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study.,"Background . Many research studies attempting to improve locomotor function following motor incomplete spinal cord injury (iSCI) focus on providing stepping practice. However, observational studies of physical therapy strategies suggest the amount of stepping practice during clinical rehabilitation is limited; rather, many interventions focus on mitigating impairments underlying walking dysfunction.  Objective . The purpose of this blinded-assessor randomized trial was to evaluate the effects of task-specific versus impairment-based interventions on walking outcomes in individuals with iSCI.  Methods . Using a crossover design, ambulatory participants with iSCI >1-year duration performed either task-specific (upright stepping) or impairment-based training for up to 20 sessions over ≤6 weeks, with interventions alternated after >4 weeks delay. Both strategies focused on achieving higher cardiovascular intensities, with training specificity manipulated by practicing only stepping practice in variable contexts or practicing tasks targeting impairments underlying locomotor dysfunction (strengthening, balance tasks, and recumbent stepping).  Results . Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes. Gains in balance confidence were also observed following task-specific vs impairment-based training, although incidence of falls was also increased with the former protocol. Limited gains were observed with impairment-based training except for peak power during recumbent stepping tests.  Conclusion . The present study reinforces work from other patient populations that the specificity of task practice is a critical determinant of locomotor outcomes and suggest impairment-based exercises may not translate to improvements in functional tasks.  Clinical Trial Registration URL . https://clinicaltrials.gov/ ; Unique Identifier: NCT02115685.",2020,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","['Individuals With Chronic Spinal Cord Injury', 'individuals with iSCI', 'ambulatory participants with iSCI >1-year duration performed either']","['Task-Specific Versus Impairment-Based Training', 'task-specific versus impairment-based interventions', 'task-specific (upright stepping) or impairment-based training']","['Gains in balance confidence', 'incidence of falls', 'Locomotor Performance', 'walking outcomes', 'fastest overground and treadmill walking speeds']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.0682405,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Lotter', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Plawecki', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Holthus', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Lucas', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320927384']
1157,32479807,Short-Term Changes in Prediction Error after Cataract Surgery in Eyes Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE


To compare short-term changes in refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN


Randomized clinical trial.
METHODS


A total of 195 eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) an Alcon model SN60WF, 2) a Hoya model XY-1, or 3) an AMO model ZCB00V. Manifest spherical equivalent (MRSE) value, PE, and changes in PE were examined at 1 day and at 1 and 2 months postoperatively and were compared among groups.
RESULTS


The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P < .0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P ≤ .0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P = .0062). IOL type and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS


The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs and were significantly smaller in the SN60WF than in the XY-1 and ZCB00V groups. Changes in PE during the 2 postoperative months were smaller in the SN60WF IOLs than in the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Saitama Hospital, Saitama, Japan; Department of Ophthalmology, Keio University Faculty of Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
1158,32482519,Effect of Calcium-Channel Blockade on the Cold-Induced Vasodilation Response.,"INTRODUCTION


Cold-induced vasodilation (CIVD) is seen in the extremities during exposure to cold. A strong vasodilation response has been associated with a decreased risk of cold injury. Increasing CIVD might further decrease this risk. The calcium-channel blocker nifedipine causes vasodilation and is used to treat Raynaud's syndrome and chilblains. Nifedipine is also used for high altitude pulmonary edema and could potentially serve a dual purpose in preventing frostbite. The effects of nifedipine on CIVD have not been studied.
METHODS


A double-blind crossover study comparing nifedipine (30 mg SR (sustained release) orally twice daily) to placebo was designed using 2 sessions of 4 finger immersion in 5°C water, with 24 h of medication pretreatment before each session. Finger temperatures were measured via nailbed thermocouples. The primary outcome was mean finger temperature; secondary outcomes were mean apex and nadir temperatures, first apex and nadir temperatures, subjective pain ranking, and time of vasodilation onset (all presented as mean±SD).
RESULTS


Twelve volunteers (age 29±3 [24-34] y) completed the study. No significant difference in finger temperature (9.2±1.1°C nifedipine vs 9.0±0.7°C placebo, P=0.38) or any secondary outcome was found. Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32). The most common adverse event was headache (32% of nifedipine trials vs 8% placebo).
CONCLUSIONS


Pretreatment with 30 mg of oral nifedipine twice daily does not affect the CIVD response in healthy individuals under cold stress.",2020,"Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32).","['Twelve volunteers (age 29±3', 'healthy individuals under cold stress']","['nifedipine', 'Nifedipine', 'calcium-channel blocker nifedipine', 'Calcium-Channel Blockade', 'Cold-induced vasodilation (CIVD', 'placebo']","['headache', 'finger temperature', 'CIVD response', 'mean finger temperature; secondary outcomes were mean apex and nadir temperatures, first apex and nadir temperatures, subjective pain ranking, and time of vasodilation onset (all presented as mean±SD', 'Finger temperatures', 'Pain levels', 'Cold-Induced Vasodilation Response']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4704948', 'cui_str': 'Cold Shock'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0006685', 'cui_str': 'Calcium Channel'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",12.0,0.224354,"Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32).","[{'ForeName': 'Brendan H A', 'Initials': 'BHA', 'LastName': 'Milliner', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, Emergency Medicine, Salt Lake City, UT; University of Utah, Division of Emergency Medicine, Salt Lake City, UT. Electronic address: Brendan.milliner@gmail.com.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Brant-Zawadzki', 'Affiliation': 'University of Utah, Division of Emergency Medicine, Salt Lake City, UT.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'McIntosh', 'Affiliation': 'University of Utah, Division of Emergency Medicine, Salt Lake City, UT.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2020.03.002']
1159,32488885,Effect of 3 Single Doses of Trazodone on QTc Interval in Healthy Subjects.,"This study evaluated the effect of 3 doses of a trazodone hydrochloride 6% oral drops solution on the QT interval of healthy volunteers. Subjects were randomly assigned to receive a single dose of trazodone 20 mg, 60 mg, and 140 mg, moxifloxacin 400 mg, and trazodone-matched placebo in 5 periods separated by 7-day washouts, according to a double-blind, crossover study design. Subjects were monitored continuously, and triplicate ECGs were extracted from baseline (predose) until 24 hours postdose. Blood samples for trazodone and moxifloxacin analyses were collected at the same time points. The concentration-QTc relationship assessed on placebo-adjusted change from baseline for Fridericia-corrected QT (ΔΔQTcF) was the primary end point. ΔΔQTcF values of 4.5, 12.3, and 19.8 ms for the 20-, 60-, and 140-mg doses were observed at the corresponding trazodone peak plasma concentrations. The upper bound of the 90%CI exceeded 10 ms for the 60- and the 140-mg doses. Time-matched analysis results were in line with these findings. No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present. In this moxifloxacin-validated ECG trial, trazodone had a modest, dose-dependent effect on cardiac repolarization, with no QTc prolongation observed with the 20-mg dose and an effect exceeding the values set in E14 guideline with the 60- and 140-mg doses. The effect on cardiac repolarization is unlikely to represent a clinical risk for ventricular proarrhythmia, but caution should be used with concomitant use of other medications that prolong QT or increase trazodone exposure.",2020,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"['healthy volunteers', 'Healthy Subjects']","['trazodone 20\xa0mg, 60\xa0mg, and 140\xa0mg, moxifloxacin 400\xa0mg, and trazodone-matched placebo', 'trazodone', 'trazodone hydrochloride 6% oral drops solution', 'Trazodone', 'moxifloxacin']","['concentration-QTc relationship', 'ΔΔQTcF values', 'heart rate or PR or QRS intervals', 'cardiac repolarization']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C1273616', 'cui_str': 'Oral drops solution'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.0666214,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tellone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Milko', 'Initials': 'M', 'LastName': 'Radicioni', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Leuratti', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}]",Journal of clinical pharmacology,['10.1002/jcph.1640']
1160,32586077,Postactivation potentiation effects of Back Squat and Barbell Hip Thrust exercise on vertical jump and sprinting performance.,"BACKGROUND


This study aimed to determine and compare the post-activation potentiation (PAP) effects of the Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises in terms of vertical jump height (VJ), 20-yard dash and 40-yard dash time in physically active university students. Considering the Force-vector theory, it was hypothesized that HT-PAP would induce greater potentiation for 40-yard dash than SQ-PAP whereas SQ-PAP would induce greater potentiation for 20-yard dash and VJ than HT-PAP.
METHODS


Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71±1.49 years; body mass, 75.58±11.89 kg; height, 173.98±11.88 cm and training experience 5.47±2.00 years) joined this study. They performed three experimental sessions namely; baseline (BL), SQ-PAP loading session and HT-PAP loading session with 48 hours interval with a randomized open crossover study design. BL session was also accepted as control and familiarization session. SQ-PAP and HT-PAP exercises were performed roughly at 90% of 1 Repetition maximum (1 RM) of the subjects with three repetitions. Subjects were tested for vertical jump height (VJ), 20-yard dash and 40-yard dash time before and 8 minutes after each PAP loading exercise.
RESULTS


Statistical analysis revealed that the potentiation effects of SQ-PAP and HT-PAP exercises on VJ height, 20-yard and 40-yard dash were similar that none of the loading exercises with 8 min rest interval had any increasing or detrimental performance effect on VJ (P=0.923), 20-yard dash (P=0.133) as well 40-yard dash time (P=0.570).
CONCLUSIONS


These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study. Although no acute potentiation effect has been found, this study also shows that SQ-PAP, HT-PAP exercises can be used interchangeably and safely to avoid training monotony during longer training periods for chronic adaptations.",2020,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","['physically active university students', 'Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71± 1.49 years; body mass, 75.58± 11.89 kg; height,173.98± 11.88 cm and training experience 5.47±2.00 years) joined this study']","['Back Squat and Barbell Hip Thrust exercise', 'Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises']","['vertical jump height (VJ), 20-yard dash and 40-yard dash time', 'vertical jump and sprinting performance', 'VJ height, 20-yard dash and 40-yard dash time', 'VJ height, 20-yard and 40-yard dash', 'SQ-PAP and HT-PAP exercises', 'vertical jump height (VJ), 20-yard dash and 40- yard dash time']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439205', 'cui_str': 'yd'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0202927,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Atalağ', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA - ozan@hawaii.edu.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Kurt', 'Affiliation': 'Department of Coaching Education, School of Kirkpinar Physical Education and Sports, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Evelin', 'Initials': 'E', 'LastName': 'Solyomvari', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}, {'ForeName': 'Ciera', 'Initials': 'C', 'LastName': 'Cline', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10888-0']
1161,32586078,Repetitions in reserve vs. maximum effort resistance training programs in youth female athletes.,"BACKGROUND


This study aimed to analyze and compare the effects of two different resistance training programs.
METHODS


Fourteen under-17 youth female basketball players were randomly assigned to repetitions in reserve (RIR, N.=7) or maximum effort (RM, N.=7) resistance training programs. The programs consisted of 3-4 sets of 4 exercises x 7-10 repetitions with 2 min of passive recovery between sets and exercises, twice a week for a period of 8 weeks. The RIR group was instructed to perform the exercises with 3 repetitions remaining (rate of perceived exertion [RPE] =7). The physical assessment included jumping, agility, and sprinting tests. Moreover, the maximum strength (one maximum-repetition [1-RM]) and muscle power output at 60% 1RM were assessed for back-squat and bench-press exercises.
RESULTS


The within-group analysis showed improvements in all tests for both groups (RIR=1.3-43.9%; RM=1.3-17.2%). Between-group analyses showed a significant interaction effect (group x time) on 1-RM bench-press (F=8.07, P<0.05, η<sup>2</sup><inf>p</inf>=0.40), favoring RIR group.
CONCLUSIONS


This study reports for the first time that the use of RIR-based RPE resistance training protocol promotes improvements in high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength, particularly in youth athletes. Considering the advantages of non-failure training, RIR training may be a suitable in-season training strategy. However, more studies are needed to confirm whether the training-induced benefits of this novel training strategy are significantly better as compared to other approaches.",2020,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","['Fourteen under-17 youth female basketball players', 'youth athletes', 'youth female athletes']","['maximum effort (RM, n = 7) resistance training programs', 'RIR-based RPE resistance training protocol', 'RIR training']","['physical assessment included jumping, agility, and sprinting tests', '1-RM bench-press', 'high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength', 'maximum strength (one maximum-repetition [1-RM]) and muscle power output']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",7.0,0.0492495,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arede', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal - jorge_arede@hotmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vaz', 'Affiliation': 'University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Faculty of Health Sciences, University of San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balsalobre-Fernandéz', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Varela-Olalla', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Madruga-Parera', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10907-1']
1162,32610563,Semantic Priming in Mild Cognitive Impairment and Healthy Subjects: Effect of Different Time of Presentation of Word-Pairs.,"INTRODUCTION


Semantic memory is impaired in mild cognitive impairment (MCI). Twomain hypotheses about this finding are debated and refer to the degradation of stored knowledgeversus the impairment of semantic access mechanisms. The aim of our study is to evaluate semanticimpairment in MCI versus healthy subjects (HS) by an experiment evaluating semantic priming.
METHODS


We enrolled 27 MCI and 20 HS. MCI group were divided, according to follow up, intoconverters-MCI and non converters-MCI. The semantic task consisted of 108 pairs of words, 54 ofwhich were semantically associated. Stimuli were presented 250 or 900 ms later the appearance ofthe target in a randomized manner. Data were analyzed using factorial ANOVA.
RESULTS


Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals. At 250 ms, both MCI and HS experienced a shorter time of response for relatedwordthan for unrelated words (priming effect), while only the converters-MCI subgroup lost thepriming effect. Further, we observed a rather larger Cohen's d effect size in non converters-MCIthan in converters-MCI.
CONCLUSION


Our data, and in particular the absence of a semantic primingeffect in converters-MCI, could reflect the impairment of semantic knowledge rather than theaccessibility of semantic stores in MCI individuals that progress to dementia.",2020,Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals.,"['Mild Cognitive Impairment and Healthy Subjects', 'mild cognitive impairment (MCI', 'healthy subjects (HS']","['Semantic Priming', 'HSand MCI', 'MCI']",['shorter time of response for relatedwordthan'],"[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",54.0,0.025956,Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Guglielmi', 'Affiliation': 'Neurology Unit, Fondazione Policlinico Agostino Gemelli-IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Quaranta', 'Affiliation': 'Neurology Unit, Fondazione Policlinico Agostino Gemelli-IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Mega', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Emanuele Maria', 'Initials': 'EM', 'LastName': 'Costantini', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Carrarini', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Innocenti', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Marra', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}]",Journal of personalized medicine,['10.3390/jpm10030057']
1163,32615951,Crowdsourcing to promote hepatitis C testing and linkage-to-care in China: a randomized controlled trial protocol.,"BACKGROUND


Hepatitis C virus (HCV) is a growing public health problem with a large disease burden worldwide. In China many people living with HCV are unaware of their hepatitis status and not connected to care and treatment. Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China. This trial aims to evaluate crowdsourcing as a strategy to improve HCV awareness, testing and linkage-to-care in China.
METHODS


A randomized controlled, two-armed trial (RCT) is being conducted in Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital. Eligible participants are ≥30 years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12 months and not known to have chronic HCV; and, having a WeChat social media account. Allocation is 1:1. Both groups will be administered a baseline and a follow-up survey (4-week post-enrollment). The intervention group will receive crowdsourcing materials to promote HCV testing once a week for two weeks and feedback will be collected thereafter, while the control group will receive no promotional materials. Feedback collected will be judged by a panel and selected to be implemented to improve the intervention continuously. Those identified positive for HCV antibodies will be referred to gastroenterologists for confirmation and treatment. The primary outcome will be confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers. Data will be collected on Survey Star @  via mobile devices.
DISCUSSION


This will be the first study to evaluate the impact of crowdsourcing to improve viral hepatitis testing and linkage-to-care in the health facilities. This RCT will contribute to the existing literature on interventions to improve viral hepatitis testing in primary care setting, and inform future strategies to improve HCV care training for primary care providers in China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. ChiCTR1900025771. Registered September 7th, 2019, http://www.chictr.org.cn/showprojen.aspx?proj=42788.",2020,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","['primary care providers in China', 'China', 'Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital', 'Eligible participants are ≥30\u2009years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12\u2009months and not known to have chronic HCV; and, having a WeChat social media account']","['crowdsourcing materials to promote HCV testing', 'control group will receive no promotional materials']","['confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",1006.0,0.0962497,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","[{'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Yang', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China. jingjingli@seshglobal.org.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fitzpatrick', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Polin', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'World Health Organization Western Pacific Regional Office, Manila, Philippines.'}, {'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}]",BMC public health,['10.1186/s12889-020-09152-z']
1164,32617881,Priming Before In Vitro Maturation Cycles in Cancer Patients Undergoing Urgent Fertility Preservation: a Randomized Controlled Study.,"In vitro maturation (IVM) of oocytes retrieved at germinal vesicle stage, followed by vitrification of mature oocytes, has emerged as a fertility preservation (FP) option. This technique was first developed for patients with polycystic ovarian syndrome. In this population, providing LH activity prior to oocyte collection has been associated with better IVM outcomes. However, the benefit of this treatment in normo-ovulatory breast cancer (BC) patients undergoing IVM for FP purpose has never been investigated. To assess if the absence of therapeutic intervention prior to oocyte retrieval for IVM modifies IVM outcomes in BC patients undergoing urgent FP, we performed a non-inferiority, randomized controlled trial. The main outcome was the total number of mature oocytes obtained and cryopreserved after IVM. A total of 172 normo-ovulatory women, suffering from BC, 18 to 39 years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36 h before oocytes retrieval according to randomized allocation. The total number of cryopreserved oocytes were 5.1 ± 3.8, 5.4 ± 3.8, and 6.0 ± 4.2 oocytes, respectively in the without, hCG and GnRHa groups. Mean differences were not significant between the three groups (- 0.5; CI 97.5% [- 2.03:1.02] and - 0.22; CI 97.5% [- 1.75:1.32], respectively). Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups. Our results are not conclusive enough to modify our practices and to stop administering hCG or GnRHa before IVM cycles for FP. The study was retrospectively registered to clinical trial (ID NCT03954197) in May 2019.",2020,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","['Cancer Patients', 'Undergoing Urgent Fertility Preservation', 'BC patients undergoing urgent FP', '172 normo-ovulatory women, suffering from BC, 18 to 39\xa0years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36\xa0h before oocytes retrieval according to randomized allocation', 'patients with polycystic ovarian syndrome']",[],"['total number of cryopreserved oocytes', 'total number of mature oocytes obtained and cryopreserved after IVM']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1171194', 'cui_str': 'Fertility care'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]",,0.232947,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sonigo', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Le Conte', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Boubaya', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Haykanush', 'Initials': 'H', 'LastName': 'Ohanyan', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Pressé', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'El Hachem', 'Affiliation': 'Department of Reproductive Medicine, Ovo Clinic, Montreal, Quebec, Canada; Department of Obstetrics and Gynecology, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cedrin-Durnerin', 'Affiliation': 'Department of Reproductive Medicine & Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Benoit', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sifer', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sermondade', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France. michael.grynberg@aphp.fr.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00244-0']
1165,32617889,Health-related quality of life of women after HPV testing as triage strategy for an abnormal Pap smear: a nested randomized pragmatic trial in a middle-income country.,"BACKGROUND


Information obtained in studies on the impact of human papilloma virus (HPV) testing on health-related quality of life is contradictory.
OBJECTIVE


To assess the impact on health-related quality of life of the HPV test, colposcopy, and cytology as triage strategies after a cytology with atypical squamous cells of undetermined significance (ASCUS) in Medellín, Colombia.
METHODS


We carried out a nested analysis on the randomized pragmatic trial (ASCUS-COL). Women with ASCUS were assigned randomly to one of the 3 arms (Pap smear, colposcopy, HPV). Participants completed a questionnaire at baseline, two weeks after receiving the results of the triage tests and one year after the second questionnaire. We used the SF-36 to assess health-related quality of life.
RESULTS


The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3: mean 54.4 (SD 8.16) p < 0.0001 and of MHC = survey 1: mean 44.9 (SD 11.72) vs. survey 3: mean 48.1 (SD 11.20) p < 0.0001. A lower MHC occurred in women with lesser schooling, belonging to the public health care regimen, higher number of live births, and separated. A lower PHC was associated with the cytology arm, higher age, lesser schooling, and belonging to the subsidized regime. The risk of having depression went from 42% in the first survey to 26% in the third.
CONCLUSION


The triage strategies affected health-related quality of life in the same manner. ClinicalTrials.gov Identifier: NCT02067468.",2020,The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3,"['Women with ASCUS', 'abnormal Pap smear', 'mean 44.9 (SD 11.72) vs. survey 3']",[],"['risk of having depression', 'sum score of the physical health component (PHC) and mental health component (MHC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521184', 'cui_str': 'Atypical squamous cells of undetermined significance'}, {'cui': 'C0476427', 'cui_str': 'Abnormal cervical smear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.235193,The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3,"[{'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Urrea Cosme', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Córdoba Sánchez', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Gloria I', 'Initials': 'GI', 'LastName': 'Sánchez', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Baena', 'Affiliation': 'Prevention and Implementation Group, International Agency for Research on Cancer / World Health Organization (IARC/WHO), 150 Cours Albert Thomas, 69372, Lyon Cedex 08, France.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Ruiz Osorio', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Zabala', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Garcés-Palacio', 'Affiliation': 'Grupo de Epidemiología, Facultad Nacional de Salud Pública, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia. icristina.garces@udea.edu.co.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02563-w']
1166,32621696,Patients use more topical medication when the medications come in a larger container.,"INTRODUCTION


Research shows that individuals consume more calories when provided with a larger portion size. It is unclear if similar behavior translates to topical medication use. The impact of container size and provider instructions on patient usage of topical medications has yet to be assessed.
METHODS


Data was collected from 128 participants in an IRB randomized, controlled trial. To a marked 3cmx8cm rectangle on the forearm, patients applied petroleum jelly from either a large container or a small tube. Pre and post application container weights were measured.
RESULTS


Patients applied more topical medication from the large container compared to the small tube.
CONCLUSION


Topical medication usage is influenced by the size of the container provided. It is beneficial to consider container size when prescribing topical medications and greater application is desired.",2020,"RESULTS


Patients applied more topical medication from the large container compared to the small tube.
","['Data was collected from 128 participants in an IRB randomized, controlled trial']",[],[],"[{'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],128.0,0.0273214,"RESULTS


Patients applied more topical medication from the large container compared to the small tube.
","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aung-Din', 'Affiliation': ''}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Seger', 'Affiliation': ''}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Unrue', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Devine', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': ''}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC Department of Social Sciences &amp; Health Policy, Wake Forest School of Medicine, Winston-Salem, NC Department of Dermatology, University of Southern Denmark, Odense. sfeldman@wakehealth.edu.'}]",Dermatology online journal,[]
1167,32627803,Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial.,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.",2020,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","['Nigeria', '60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring']",['community health worker support and home monitoring'],"['blood pressure control', 'systolic blood pressure']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",60.0,0.0620388,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","[{'ForeName': 'Dike B', 'Initials': 'DB', 'LastName': 'Ojji', 'Affiliation': 'Cardiology Unit, Department of Medicine, College of Health Sciences, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria. Email: dike.ojji@uniabuja,edu,ng.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Baldridge', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Orji', 'Affiliation': 'Disease Control Unit, Department of Health, Abuja Municipal Area Council, Federal Capital Territory, Nigeria.'}, {'ForeName': 'Lamkur G', 'Initials': 'LG', 'LastName': 'Shedul', 'Affiliation': 'Department of Family Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Olubunmi I', 'Initials': 'OI', 'LastName': 'Ojji', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Nonye B', 'Initials': 'NB', 'LastName': 'Egenti', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Ada M', 'Initials': 'AM', 'LastName': 'Nwankwo', 'Affiliation': 'Department of Community Medicine, College of Health Sciences University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-066']
1168,32623947,"Is ""Response/No Response"" Too Simple a Notion for RTI Frameworks? Exploring Multiple Response Types With Latent Profile Analysis.","We conducted a secondary analysis of data from a randomized control trial to explore this question: Does ""response/no response"" best characterize students' reactions to a generally efficacious first-grade reading program, or is a more nuanced characterization necessary? Data were collected on 265 at-risk readers' word reading prior to and immediately following program implementation in first grade and in spring of second grade. Pretreatment data were also obtained on domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning). Latent profile analysis of word reading across the three time points with controls as a local norm revealed a  strongly responsive  group ( n  = 45) with mean word-reading  z  scores of 0.25, 1.64, and 1.26 at the three time points, respectively; a  mildly responsive  group ( n  = 109),  z  scores = 0.30, 0.47, and 0.55; a  mildly non-responsive  group ( n  = 90),  z  scores = -0.11, -0.15, and -0.55; and a  strongly non-responsive  group ( n  = 21),  z  scores = -1.24, -1.26, and -1.57. The two responsive groups had stronger pretreatment letter knowledge and passage comprehension than the two non-responsive groups. The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group. No domain-general skill distinguished the four groups. Findings suggest response to early reading intervention was more complicated than response/no response, and pretreatment reading comprehension was an important predictor of response even with pretreatment word reading controlled.",2020,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,[],[],"['Response', 'pretreatment passage comprehension', 'stronger pretreatment letter knowledge and passage comprehension', 'domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning']",[],[],"[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0174433,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Peng', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Michigan State University, East Lansing, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Elleman', 'Affiliation': 'Middle Tennessee State University, Mufreesboro, USA.'}, {'ForeName': 'Devin M', 'Initials': 'DM', 'LastName': 'Kearns', 'Affiliation': 'University of Connecticut, Storrs, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Patton', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Compton', 'Affiliation': 'Florida State University, Tallahassee, USA.'}]",Journal of learning disabilities,['10.1177/0022219420931818']
1169,32580724,The clinical relevance of early identification and treatment of sleep disorders in mental health care: protocol of a randomized control trial.,"BACKGROUND


Sleep disorders are a risk factor for developing a variety of mental disorders, have a negative impact on their remission rates and increase the risk of relapse. Early identification and treatment of sleep disorders is therefore of paramount importance. Unfortunately, in mental health care sleep disorders are often poorly recognized and specific treatment frequently occurs late or not at all. This protocol-paper presents a randomized controlled trial investigating the clinical relevance of early detection and treatment of sleep disorders in mental health care. The two aims of this project are 1) to determine the prevalence of sleep disorders in different mental disorders, and 2) to investigate the contribution of early identification and adequate treatment of sleep disorders in individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life.
METHODS


Patients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ). Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder. Participants will be randomly assigned to two groups: Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention (TAU+SI-T1; 6 months after inclusion). The effect of sleep treatment as add-on to treatment as usual (TAU) will be tested with regard to sleep disorder symptoms, general functioning, and quality of life (in collaboration with a psychiatric sleep centre).
DISCUSSION


This trial will examine the prevalence of different sleep disorders in a broad range of mental disorders, providing information on the co-occurrence of specific sleep and mental disorders. Further, this study is the first to investigate the impact of early treatment of sleep disorders on the outcome of many mental disorders. Moreover, standard sleep interventions will be tailored to specific mental disorders, to increase their efficacy. The results of this trial may contribute considerably to the improvement of mental health care.
TRIAL REGISTRATION


This clinical trial has been retrospectively registered in the Netherlands Trial Register (NL8389; https://www.trialregister.nl/trial/8389) on February 2th, 2020.",2020,"Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder.","['individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life', 'sleep disorders in mental health care', 'Patients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ']","['standard sleep interventions', 'Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",[],,0.0656405,"Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder.","[{'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Ter Heege', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'Mijnster', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Maaike M', 'Initials': 'MM', 'LastName': 'van Veen', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Gerdina H M', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gretha J', 'Initials': 'GJ', 'LastName': 'Boersma', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'Lancel', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands. marike.lancel@ggzdrenthe.nl.'}]",BMC psychiatry,['10.1186/s12888-020-02737-3']
1170,32605893,First-iGAP: A Randomized Placebo-Controlled Phase II Study of First-line Intercalated Gefitinib and Pemetrexed-Cisplatin Chemotherapy for Never-Smoker Lung Adenocarcinoma Patients.,"BACKGROUND


We aimed to evaluate whether intercalated combination of EGFR tyrosine kinase inhibitor gefitinib and chemotherapy improves survival outcomes in never-smokers with advanced lung adenocarcinoma.
PATIENTS AND METHODS


Never-smokers with chemo-naive stage IIIB/IV lung adenocarcinoma were randomly assigned to receive either gefitinib or placebo on days 5 to 18 of a 3-weekly cycle of pemetrexed and cisplatin. Chemotherapy was given up to 9 cycles, after which gefitinib or placebo was given daily. Patients in the placebo arm who had progression were crossed over to receive gefitinib.
RESULTS


Between June 2012 and December 2014, 76 patients with median age of 58.0 years were randomized, 39 on gefitinib and 37 on the placebo arm. EGFR mutation was positive in 34 (44.7%) patients. Baseline characteristics were well balanced between the 2 arms. The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412). The PFS benefit of intercalated use of gefitinib over placebo was more apparent for patients with EGFR-mutant tumors (13.3 vs. 7.8 months, P = .025) than those with EGFR-wild-type tumors (8.2 vs. 6.6 months, P = .063). Overall, there was no difference in the frequency of severe adverse effect between the 2 arms.
CONCLUSIONS


Intercalated combination of gefitinib with pemetrexed and cisplatin was well tolerated and improved PFS in never-smoker patients with lung adenocarcinoma.",2020,"The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412).","['Never-smokers with chemo-naive stage IIIB/IV lung adenocarcinoma', 'Never-Smoker Lung Adenocarcinoma Patients', 'never-smokers with advanced lung adenocarcinoma', 'never-smoker patients with lung adenocarcinoma', 'Between June 2012 and December 2014, 76 patients with median age of 58.0 years were randomized, 39 on gefitinib and 37 on the']","['Placebo', 'gefitinib or placebo', 'Chemotherapy', 'iGAP', 'pemetrexed and cisplatin', 'gefitinib with pemetrexed and cisplatin', 'First-line Intercalated Gefitinib and Pemetrexed-Cisplatin Chemotherapy', 'EGFR tyrosine kinase inhibitor gefitinib and chemotherapy', 'placebo']","['frequency of severe adverse effect', 'tolerated and improved PFS', 'median progression-free survival (PFS', 'median overall survival', 'EGFR mutation', 'response rate', 'survival outcomes']","[{'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.372775,"The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412).","[{'ForeName': 'Youngjoo', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Hyae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Center for Clinical Trials, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Geon Kook', 'Initials': 'GK', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Heung Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Jin Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea. Electronic address: jslee@ncc.re.kr.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.05.003']
1171,32614227,Feasibility and acceptability of a novel tool for the study of interpersonal processes in psychotherapy.,"Psychotherapy process research methods often require extensive time and resources. Technology innovations, such as wearable sensors, have the potential to increase the efficiency of process data collection and processing. One such tool is the Sociometric Badge (SB), which is a portable, palm-sized device that can simultaneously record raw audio and data on social signals (e.g., speech patterns, body movement) in real-time and in varied contexts. In addition to describing the nature and implications of wearable sensing devices for psychotherapy research, this article reports results from a pilot study that examined the feasibility and acceptance of these assessment devices in comparison with traditional audio recording equipment. Undergraduate students (N = 306; Mage = 19.16 years, SD = 1.44; 50.3% female) were randomly placed into 153 dyads to mimic a psychotherapy dyad. Each dyad was randomly assigned to either a SB condition (n = 75 dyads) or a standard recording device condition (n = 78 dyads), and engaged in a conversation task. Participants completed self-report items assessing perceived relationship quality and experience with the respective recording device. Between-condition tests showed that perceived relationship quality did not differ between conditions. Participants in the audio recorder (vs. SB) condition reported more awareness of the device in the room. These findings reveal comparable acceptability and feasibility of SBs to traditional audio recorders in a simulated dyad, suggesting that wearable sensing devices may be suitable for research and practice in routine psychotherapy contexts. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Between-condition tests showed that perceived relationship quality did not differ between conditions.,"['Undergraduate students (N = 306; Mage = 19.16 years, SD = 1.44; 50.3% female']","['standard recording device condition', 'SB condition']","['relationship quality', 'Feasibility and acceptability']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0364484,Between-condition tests showed that perceived relationship quality did not differ between conditions.,"[{'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna-Kaisa', 'Initials': 'AK', 'LastName': 'Newheiser', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Oswald', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bugatti', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Cedeno', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}]",Journal of counseling psychology,['10.1037/cou0000385']
1172,32618242,Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods.,"From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care. Acceptability of the intervention was assessed quantitatively using closed-ended and Likert scale-based questions posed during three household surveys conducted from April to May in 2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls. In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms. Concurrently, 27 focus group discussions and 23 in-depth interviews with 248 participants were conducted on reasons for testing and treatment refusal, reasons for nonadherence, and community perception of the MDA campaign. Results demonstrated that the MDA campaign was highly accepted with more than 99% of respondents stating that they would take treatment if positive for malaria. High acceptability at baseline could be associated with test-and-treat campaigns recently conducted in the study area. There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each. This likely resulted from an intensive community-wide sensitization program that occurred before the first treatment round at each household during community health worker visits.",2020,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","['2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls', 'In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms', 'Malaria in Zambia Using Mixed Methods', 'From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care']",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],[],248.0,0.0973838,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","[{'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jennings', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Chilumba', 'Initials': 'C', 'LastName': 'Sikombe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chiyende', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0663']
1173,32618245,"A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia.","Rigorous evidence of effectiveness is needed to determine where and when to apply mass drug administration (MDA) or focal MDA (fMDA) as part of a malaria elimination strategy. The Zambia National Malaria Elimination Centre recently completed a community-randomized controlled trial in Southern Province to evaluate MDA and fMDA for transmission reduction. To assess the role of MDA and fMDA on infection incidence, we enrolled a longitudinal cohort for an 18-month period of data collection including monthly malaria parasite infection detection based on polymerase chain reaction and compared time to first infection and cumulative infection incidence outcomes across study arms using Cox proportional hazards and negative binomial models. A total of 2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis. Infection incidence declined dramatically across all study arms during the period of study, and MDA was associated with reduced risk of first infection (hazards ratio: 0.36; 95% CI: 0.16-0.80) and cumulative infection incidence during the first rainy season (first 5 months of follow-up) (incidence rate ratio: 0.34; 95% CI: 0.12-0.95). No significant effect was found for fMDA or for either arm over the full study period. Polymerase chain reaction infection status at baseline was strongly associated with follow-up infection. The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.",2020,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"['Southern Province, Zambia', '2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis']","['MDA', 'MDA and fMDA']","['Infection incidence', 'cumulative infection incidence', 'Polymerase chain reaction infection status', 'reduced risk of first infection']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2026.0,0.0828922,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Mulenga C', 'Initials': 'MC', 'LastName': 'Mwenda', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Mambwe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chishimba', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Conceptor', 'Initials': 'C', 'LastName': 'Mulube', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bridges', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0657']
1174,32618247,"Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia.","Over the past decade, Zambia has made substantial progress against malaria and has recently set the ambitious goal of eliminating by 2021. In the context of very high vector control and improved access to malaria diagnosis and treatment in Southern Province, we implemented a community-randomized controlled trial to assess the impact of four rounds of community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP) implemented between December 2014 and February 2016. The mass treatment campaigns achieved relatively good household coverage (63-79%), were widely accepted by the community (ranging from 87% to 94%), and achieved very high adherence to the DHAP regimen (81-96%). Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial. Children in areas of lower transmission (< 10% prevalence at baseline) that received four MDA rounds had a 72% (95% CI = 12-91%) reduction in malaria parasite prevalence as compared with those with the standard of care without any mass treatment. Mass drug administration consistently had the largest short-term effect size across study end points in areas of lower transmission following the first two MDA rounds. In the context of achieving very high vector control coverage and improved access to diagnosis and treatment for malaria, our results suggest that MDA should be considered for implementation in African settings for rapidly reducing malaria outcomes in lower transmission settings.",2020,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","['Southern Province', 'Southern Province, Zambia']","['community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP', 'Dihydroartemisinin-Piperaquine', 'MDA']","['malaria parasite prevalence', 'overall parasite prevalence']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0868305,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chalwe', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kooma', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Mulakwa', 'Initials': 'M', 'LastName': 'Kamuliwo', 'Affiliation': 'Zambia Ministry of Health, Southern Provincial Health Office, Choma, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Kammerle', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0659']
1175,32621898,The Aravind Pseudoexfoliation Study: 5-Year Postoperative Results. The Effect of Intraocular Lens Choice and Capsular Tension Rings.,"PURPOSE


We compared rates of intraocular lens (IOL) decentration, neodymium-doped yttrium aluminum garnet capsulotomy for posterior capsule opacification (PCO), and visual acuity (VA) in eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery.
DESIGN


Prospective comparative interventional study.
METHODS


This multicenter study population included 1 eye of both 930 cataract patients with and 470 cataract patients without uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons. Eyes were randomized to either 1- or 3-piece intraocular lenses (IOLs). PEX eyes were also randomized to either receive or not receive a capsule tension ring. The main outcome measures included IOL decentration and PCO. Secondary outcomes included postoperative best-corrected VA.
RESULTS


Follow-up was 86.2% in the PEX group and 86.7% in the control group at 5 years. The PEX group was older (P < .001) and had more men (P = .01). IOL decentration at 5 years was equally prevalent in PEX and control eyes (1.0% vs 1.1%, respectively, P = .8). Neodymium-doped yttrium aluminum garnet posterior capsulotomy rates for PCO were similar in the PEX group when compared with control subejcts (5.3% compared with 3.2%, respectively, P = .07). Best corrected VA was better at baseline and years 2 and 3 in the control group (P = .0001, P = .0005, and P = .02); however, there was no difference in BCVA at years 1, 4, and 5 between the PEX and control groups (P = .09, P = .29, and P = .5).
CONCLUSION


In a large-scale, long-term, prospective comparative study of cataract surgery in eyes with uncomplicated PEX, the risks of IOL decentration and PCO were low and comparable to that in control subjects. When approaching cataract surgery in eyes with relatively uncomplicated PEX, neither IOL choice (1- vs 3-piece acrylic IOL) nor the presence/absence of a capsule tension ring affects outcomes at 5 years.",2020,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","['eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery', '930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons', 'PEX eyes']","['one-piece or three-piece intraocular lenses (IOL', 'PEX', 'IOL decentration, Nd:YAG capsulotomy', 'capsule tension ring (CTR', 'cataract surgery']","['PCO', 'post-operative best corrected VA', 'IOL decentration', 'IOL decentration and posterior capsular opacification (PCO', 'Best corrected visual acuity (BCVA', 'BCVA', 'posterior capsule opacification (PCO), and visual acuity (VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C2939415', 'cui_str': 'Phacodonesis'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0815359,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Haripriya', 'Affiliation': 'Aravind Eye Hospital, Chennai, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Schehlein', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Chandrashekharan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Narendran', 'Affiliation': 'Aravind Eye Hospital, Coimbatore, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sithiq', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Rengappa', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Ravilla D', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA; Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. Electronic address: arobin@glaucomaexpert.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.031']
1176,32623402,"Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Probiotics use has been associated with modulation of inflammation and considered as a possible intervention for CNS diseases such as mild cognitive impairment (MCI) and dementia.
OBJECTIVE


We aimed to test the effect of the probiotic strain, Bifidobacterium breve A1 (MCC1274), to restore cognition in a physically healthy, suspected MCI population.
METHODS


In this randomized, double-blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were divided into two even groups to receive once daily either probiotic (B. breve A1, 2×1010 CFU) or placebo for 16 weeks using a computer-generated algorithm. Cognitive functions were assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests before and after the study as primary and secondary endpoints, respectively.
RESULTS


79 participants completed the study, and no adverse events were observed. RBANS total score was significantly improved in probiotic group compared with placebo (mean between-group difference 11.3 [95% CI 6.7 to 15.8]; p < 0.0001) after 16 weeks of consumption, in particular with significant improvement in domain scores of immediate memory, visuospatial/constructional, and delayed memory (p < 0.0001), in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
CONCLUSION


Study results indicate B. breve A1 is a safe and effective approach for improving memory functions of suspected MCI subjects.",2020,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","['suspected MCI subjects', 'physically healthy, suspected MCI population', '80 healthy older adults suffering from MCI', 'Older Adults with Suspected Mild Cognitive Impairment']","['Placebo', 'Probiotic Bifidobacterium breve', 'probiotic strain, Bifidobacterium breve A1 (MCC1274', 'probiotic (B. breve A1, 2×1010 CFU) or placebo', 'placebo']","['Cognitive functions', 'JMCIS score', 'Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests', 'Cognitive Functions', 'domain scores of immediate memory, visuospatial/constructional, and delayed memory', 'RBANS total score']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.666455,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","[{'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bernier', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ohno', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Odamaki', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Huma R & D Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Kumie', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Nihonbashi Sakura Clinic, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Tokyo, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200488']
1177,32488245,Effectiveness of a Khorasan Wheat-Based Replacement on Pain Symptoms and Quality of Life in Patients with Fibromyalgia.,"OBJECTIVE


To investigate the effects of a replacement diet with Khorasan wheat products in patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat.
DESIGN


Randomized, double-blinded crossover trial.
SETTING


Outpatient clinic.
SUBJECTS


Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3 years) with fibromyalgia.
METHODS


Participants were randomly assigned to consume either Khorasan or control wheat products (pasta, bread, crackers, biscuits) for eight weeks and then crossed. Validated self-administered questionnaires were collected from each subject at the beginning and end of each intervention period.
RESULTS


A general linear model for repeated measurement, adjusted for potential confounders, showed that the overall score reported from each questionnaire improved after both intervention and control periods, but the effect was more evident after the intervention with Khorasan. In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period. Similarly, FM Impact Questionnaire scores decreased significantly only after the Khorasan period, with a reduction that was significantly different between the intervention and control periods (-22.5% vs -0.3%, P = 0.037). The improvement was even greater in people with higher symptom severity.
CONCLUSIONS


A dietary intervention with Khorasan wheat products seems to benefit patients with fibromyalgia, especially those with greater symptom severity.",2020,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","['Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3\u2009years) with fibromyalgia', 'patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat', 'Patients with Fibromyalgia', 'Participants', 'Outpatient clinic']","['Khorasan or control wheat products (pasta, bread, crackers, biscuits', 'replacement diet with Khorasan wheat products', 'Khorasan Wheat-Based Replacement']","['FM Impact Questionnaire scores', 'Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ', 'Pain Symptoms and Quality of Life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3853226', 'cui_str': 'Khorasan wheat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.0494743,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Colombini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Masoni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Danza', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Amedei', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ballerini', 'Affiliation': 'Multidisciplinary Center for Pain Therapy, Reference Center for Fibromyalgia, Piero Palagi Hospital, USL Toscana Centro, Florence, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benedettelli', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa134']
1178,32583727,Effects of an aerobic fitness test on short- and long-term memory in elementary-aged children.,"Meta-analytic evidence supports that exercise has benefits for short-term memory (STM) and long-term memory (LTM). However, only three studies with children have tested the differential effects of exercise on STM and LTM. The purpose of this study was to examine the effects of an aerobic fitness test on STM and LTM and to consider the moderating effects of grade level. Children (7-13 years of age) were randomly assigned to either perform an aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT) to assess memory. Memory was tested again after approximately 24 hours. There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders. For learning, Day 1 Retention, 24-hr recall, and Day 2 Retention, the exercise prior group performed better than the exercise post group. It is concluded that an aerobic fitness test performed prior to a declarative memory test benefits LTM as compared to when the aerobic fitness test is performed after the memory test.",2020,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"['Children (7-13\xa0years of age', 'elementary-aged children']","['aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT', 'aerobic fitness test']","['short- and long-term memory', 'memory performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.031325,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sprick', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Chia-Hao', 'Initials': 'CH', 'LastName': 'Shih', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Glass', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jarod C', 'Initials': 'JC', 'LastName': 'Vance', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1778251']
1179,32583907,Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.,"BACKGROUND


Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US.
AIM


To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C.
METHODS


A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥6/12 weeks).
RESULTS


The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose-response relationship was found. A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhoea.
CONCLUSIONS


Minesapride was safe and well-tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency. Japan Pharmaceutical Information Center Number: Japic CTI-163459.",2020,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","['irritable bowel syndrome with predominant constipation (IBS-C', 'patients with Rome IV defined IBS-C', 'irritable bowel syndrome with predominant constipation', '411 patients']","['5-hydroxytryptamine', 'minesapride vs placebo', 'minesapride', 'placebo']","['stricter composite endpoint and SBM frequency', 'SBM frequency', 'Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements', 'efficacy and safety', 'safe and well-tolerated', 'worst abdominal pain score', 'FDA composite responder rate']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",411.0,0.467554,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15907']
1180,32592568,[General hydro galvanic baths in the treatment of patients with lumbosacral radiculopathy].,"INTRODUCTION


Hydrogalvanic baths are a hydrotherapy method based on the combined effect of electric current and fresh water on the body.
AIM OF STUDY


Scientific evidence and evaluation of the effectiveness of use of general hydrogalvanic baths in the treatment of patients with lumbosacral radiculopathy with the background of degenerative spinal disorder.
MATERIALS AND METHODS


A randomized comparative clinical trial included 84 patients. The 1st (active) group included 43 patients, the 2nd (control) had 41 patients. Patients of the 1st group received general hydrogalvanic baths. Patients in the control group  -  drug treatment, including NSAIDs, muscle relaxants, anticonvulsants. The assessment was carried out before treatment, at the end of the course (on the 14th day) and 3 months after the end of treatment according to the results of neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study).
RESULTS


In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%,  p =0.008) and conductivity in peripheral sensory fibers. A decrease in pain was observed in both groups, however, a decrease in neuropathic pain was recorded only in patients receiving drug treatment. In the 1st group during therapy, an improvement in the emotional state in patients and a decrease in the level of depression were revealed. An analysis of long-term results showed that the delayed effect of non-drug treatment significantly increased in patients of the 1st group in comparison with the control group ( p <0.05).
CONCLUSIONS


Exposure to general hydrogalvanic baths is an effective way to treat lumbosacral radiculopathy, the main registered effects are: improvement of sensitivity, reduction of pain and stabilization of the emotional background. However, the studied method does not affect neuropathic pain.",2020,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%,  p =0.008) and conductivity in peripheral sensory fibers.","['43 patients, the 2nd (control) had 41 patients', '84 patients', 'patients with lumbosacral radiculopathy', 'patients with lumbosacral radiculopathy with the background of degenerative spinal disorder']",['general hydrogalvanic baths'],"['sensitivity (the incidence of hypesthesia', 'emotional state', 'conductivity in peripheral sensory fibers', 'delayed effect of non-drug treatment', 'pain', 'neuropathic pain', 'level of depression', 'neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral radiculopathy'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0037933', 'cui_str': 'Disorder of vertebral column'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0919609', 'cui_str': 'Electroneuromyography'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}]",84.0,0.0368616,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%,  p =0.008) and conductivity in peripheral sensory fibers.","[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Borodulina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Badalov', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mukhina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Gushcha', 'Affiliation': 'Scientific center of neurology, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Marfina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Volovets', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703135']
1181,32592569,[Comparative evaluation of effectiveness of different magnetotherapy regimens in patients with osteoarthritis].,"Impulse low-frequency magnetotherapy is a modern method of treating diseases of the musculoskeletal system, including osteoarthritis. The effectiveness of the therapeutic effect largely depends on the biotropic characteristics of the magnetic fields - the type of magnetic field, induction, frequency, pulse shape, exposure, exposure zone.
AIM OF STUDY


To conduct a comparative analysis of effectiveness of applying various modes of magnetotherapy using an impulse low-frequency magnetic field in patients with osteoarthritis.
MATERIALS AND METHODS


A randomized, placebo-controlled clinical trial included 262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification. The 1st group included 56 patients who received local magnetic therapy on the knee using a running pulsed magnetic field (RPMF) - 20 mT, frequency 6.25 Hz, exposure time 20 min. The 2nd group included 99 patients who were exposed to a magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF) with induction of 2 mT, frequency of 100 Hz, then RPMF mode - 20 mT, frequency of 6.25 Hz, duration 20 min, number of procedures - 12. The third group included 97 patients who received placebo-magnetotherapy on the knee joint area. When analyzing the results, the VAS (100 mm) and WOMAC scales were used, as well as the subjective assessment of the treatment results by patients (5-point scale).
RESULTS


A pronounced symptom-modifying effect of magnetotherapy (according to VAS and WOMAC) was established in the form of a decrease in the severity of pain in patients with gonarthrosis ( p <0.01). There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01). The use of magnetotherapy using various modes is safe for patients and does not cause serious adverse events.
CONCLUSION


The application of magnetotherapy equipment, which allows the use of various biotropic characteristics of magnetic field, is an effective and safe technology for treatment of patients with osteoarthritis.",2020,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","['99 patients who were exposed to a', 'patients with osteoarthritis', '56 patients who received', '262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification']","['magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF', 'local magnetic therapy', 'magnetotherapy', 'placebo-magnetotherapy', 'magnetotherapy regimens', 'placebo']","['pain and stiffness indices', 'WOMAC scales', 'functional characteristics (WOMAC', 'severity of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0872210', 'cui_str': 'Magnetic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",262.0,0.0229588,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","[{'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Osnovina', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Alekseeva', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703143']
1182,32592571,[Transcerebral magnetic and shock wave therapy in correction of erectile dysfunction].,"Given the complex pathogenesis of erectile dysfunction (ED), the inclusion of not only effective local physiotherapeutic effects, but also general physiotherapy methods into the treatment complexes of patients with ED is most justified. Transcerebral exposure to magnetic fields occupies a special place among them.
AIM OF STUDY


Development and scientific justification of a new complex physiotherapeutic method, including shock wave therapy (SVT) and transcerebral magnetotherapy, for the treatment of patients with ED.
MATERIALS AND METHODS


A prospective randomized study was carried out, which included 40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia. The 1st group (comparison) included 20 patients who received only 7 SVT procedures. The 2nd group (main) included 20 patients who received a comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7).
RESULTS


As a result of course of SVT in combination with transcerebral magnetotherapy, the total score according to the IIEF-5 questionnaire in patients increased by 34.1% ( p  <0.05), comparing with patients receiving only SVT (20.7%). In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%. It was found that the high clinical results of use of SVT in combination with transcerebral magnetotherapy are based on the compensation of local blood circulation, which manifests itself in eliminating the deficiency of blood supply by improving the tone of arterial vessels and eliminating venous stasis according to laser Doppler flowmetry (LDF). The inclusion of transcerebral magnetotherapy in the treatment complex helps to increase the level of total testosterone.
CONCLUSION


Higher therapeutic efficacy of the complex treatment of patients with ED using SVT and transcerebral magnetotherapy was revealed.",2020,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","['40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia', 'patients with ED', '20 patients who received a', '20 patients who received only 7 SVT procedures']","['comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7', 'Transcerebral magnetic and shock wave therapy', 'shock wave therapy (SVT) and transcerebral magnetotherapy', 'SVT']","['IIEF-5 questionnaire', 'level of total testosterone', 'Goldstein scale', 'quality of hardness of erection', 'therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022537', 'cui_str': 'Kazakhstan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0406353', 'cui_str': 'Multiple minute digitate hyperkeratosis of Goldstein'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0156503,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","[{'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Konchugova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kulchitskaya', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Kiyatkin', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Gushchina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703160']
1183,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS


Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS


The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS


There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE


Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1184,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing the two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (May 2015-August 2019 in St Louis, Missouri), smokers were randomized by genotype in blocks of six (1:1:1 ratio) to three conditions: 12 weeks of placebo (n = 273), combination nicotine patch and lozenge (combination nicotine replacement therapy, cNRT, n = 275), or varenicline (n = 274). All participants received counseling and were followed for 12 months. The primary end point was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (https://clinicaltrials.gov/) (NCT02351167). We conducted the genetic analyses separately for 516 European ancestry (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (χ 2   = 10.7, degrees of freedom = 2. P = 0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotype than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance smoking cessation treatment effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971']
1185,32609294,Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.,"Importance


Facilitating the development of safe and effective medications for schizophrenia is a public health imperative.
Objectives


To evaluate the association of shortening randomized clinical trial (RCT) duration with the modification of the Positive and Negative Syndrome Scale (PANSS) for the design of RCTs of medications for schizophrenia and to offer perspective on an alternative regulatory pathway to the historically accepted trial duration and response assessment.
Data Sources


A database was created consisting of clinical trial data from 32 placebo-controlled RCTs of 8 atypical antipsychotic drugs approved by the US Food and Drug Administration (FDA) between January 1, 2001, and December 31, 2015. The database included information on total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs).
Study Selection


All clinical trials submitted to 8 new drug applications of atypical antipsychotic drugs were selected.
Data Extraction and Synthesis


Quality control checks were performed to ensure that the collected data were consistent with the reported results of each trial. Data were collected from March 15, 2015, to September 30, 2015. Data analysis was conducted from October 1, 2015, to June 20, 2016.
Main Outcomes and Measures


The following analyses were performed: (1) longitudinal assessment of mean change from baseline in total PANSS score, (2) correlation analyses between change from baseline in total PANSS score at week 6 and earlier time points, (3) concordance analyses of outcomes across trials between week 6 and earlier time points using total PANSS and modified PANSS, and (4) analyses of time course of treatment-emergent AEs.
Results


The final database contained data from 14 219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals. The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years. Statistically significant separation between treatment response and placebo response was observed after 1 week of treatment. The overall concordance rate across treatment groups steadily increased from week 1 to week 4 (68.0% for week 1, 74.0% for week 2, 83.0% for week 3, and 93.0% for week 4). Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6. The overall concordance rate between change from baseline in the modified PANSS score and change from baseline in the total PANSS score was 93.0% (80 of 86 treatment groups) at week 4 and 97.7% (84 of 86 treatment groups) at week 6. Shortening the trial duration to 4 weeks increased the required sample size to 502 participants. Using the modified PANSS as the end point, the sample size for a 4-week trial was 402 participants and 296 participants for a 6-week trial.
Conclusions and Relevance


Findings from this analysis suggest that there is the potential to streamline the design of schizophrenia drug clinical trials. Trial sponsors may consider incorporating these strategies and are encouraged to consult with the FDA early in the drug development process.",2020,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","['The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years', '402 participants and 296 participants for a 6-week trial', '14\u202f219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals']",[],"['total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs', 'overall concordance rate', 'total PANSS score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",14219.0,0.0619414,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","[{'ForeName': 'Islam R', 'Initials': 'IR', 'LastName': 'Younis', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Mathis', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Uppoor', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Farchione', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1596']
1186,32605614,"A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.","BACKGROUND


The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.
METHODS


The study will be implemented as a randomized controlled trial. A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C) TAU only (control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Repeated-measures ANOVA will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to group C and that group B will achieve better outcomes than group A.
DISCUSSION


This study is the first trial examining the effectiveness of stimuli-relevant AATP delivered in a VR environment. The use of VR has shown promise in enhancing the effectiveness of other psychological treatments and since AATP has already been shown effective as add-on treatment, it is of interest to investigate whether these effects can be further enhanced by implementing the program in more ecologically valid environments. If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04283305 Registration date: 24.02.20.",2020,"If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment.
","['A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark']","['AATP', 'standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C', 'TAU', 'approach-avoidance training', 'virtual reality based, approach-avoidance training program', 'avoidance training program (AATP', 'stimuli-relevant AATP']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0360521,"If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment.
","[{'ForeName': 'Angelina Isabella', 'Initials': 'AI', 'LastName': 'Mellentin', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark. amellentin@health.sdu.dk.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Ascone', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Wirtz', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Samochowiec', 'Affiliation': 'Department of Psychiatry Pomeranian Medical University in Szczecin Poland, Szczecin, Poland.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Kucharska-Mazur', 'Affiliation': 'Department of Psychiatry Pomeranian Medical University in Szczecin Poland, Szczecin, Poland.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Schadow', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Lebiecka', 'Affiliation': 'Department of Psychiatry Pomeranian Medical University in Szczecin Poland, Szczecin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Skoneczny', 'Affiliation': 'Department of Psychiatry Pomeranian Medical University in Szczecin Poland, Szczecin, Poland.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mistarz', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bremer', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02739-1']
1187,32613281,Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma.,"The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (n = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1-4. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade ≥ 3 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413.",2020,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.",['multiple myeloma patients'],"['ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT', 'Ixazomib', 'ixazomib', 'placebo']","['diarrhea', 'rate of grade ≥\u20093 AEs', 'progression-free survival', 'thrombocytopenia', 'rate of discontinuation due to AEs', 'vomiting', 'cumulative, long-term, or late-onset toxicity']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0639010', 'cui_str': '3-(2-aminoethyl)-8-(3-(4-fluorobenzoyl)propyl)-4-oxo-1-phenyl-1,3,8-triazaspiro(4.5)decan-4-one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.566705,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK. Martin.Kaiser@icr.ac.uk.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksaç', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gulbrandsen', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Arriba de la Fuente', 'Affiliation': 'Servicio de Hematología y Oncología Médica, Hospital Universitario Morales Meseguer y Centro Regional de Hemodonación, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca, CIC, IBM CC, Salamanca, Spain.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czorniak', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Annals of hematology,['10.1007/s00277-020-04149-5']
1188,32618249,"Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial.","Community-wide administration of antimalarial drugs in therapeutic doses is a potential tool to prevent malaria infection and reduce the malaria parasite reservoir. To measure the effectiveness and cost of using the antimalarial drug combination dihydroartemisinin-piperaquine (DHAp) through different community-wide distribution strategies, Zambia's National Malaria Control Centre conducted a three-armed community-randomized controlled trial. The trial arms were as follows: 1) standard of care (SoC) malaria interventions, 2) SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA. Mass drug administration consisted of offering all eligible individuals DHAP, irrespective of a rapid diagnostic test (RDT) result. Focal mass drug administration consisted of offering DHAP to all eligible individuals who resided in a household where anyone tested positive by RDT. Results indicate that the costs of fMDA and MDA per person targeted and reached are similar (US$9.01 versus US$8.49 per person, respectively,  P  = 0.87), but that MDA was superior in all cost-effectiveness measures, including cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted. Subsequent costing of the MDA intervention in a non-trial, operational setting yielded significantly lower costs per person reached (US$2.90). Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations. A sensitivity analysis using costs from operational deployment and trial effectiveness yielded improved cost-effectiveness estimates. Mass drug administration may be a cost-effective intervention in the Zambian context and can help reduce the parasite reservoir substantially. Mass drug administration was more cost-effective in relatively higher transmission settings. In all scenarios examined, the cost-effectiveness of MDA was superior to that of fMDA.",2020,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","['Southern Province, Zambia', 'eligible individuals who resided in a household where anyone tested positive by RDT']","['SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA', 'MDA intervention', 'Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine', 'antimalarial drug combination dihydroartemisinin-piperaquine (DHAp']","['costs of fMDA and MDA', 'cost-effectiveness of MDA', 'cost-effectiveness estimates', 'cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.139118,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","[{'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Callie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0661']
1189,32618251,"Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia.","Mass drug administration (MDA) is currently being considered as an intervention in low-transmission areas to complement existing malaria control and elimination efforts. The effectiveness of any MDA strategy is dependent on achieving high epidemiologic coverage and participant adherence rates. A community-randomized controlled trial was conducted from November 2014 to March 2016 to evaluate the impact of four rounds of MDA or focal MDA (fMDA)-where treatment was given to all eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000). This study examined epidemiologic coverage and program reach using capture-recapture and satellite enumeration methods to estimate the degree to which the trial reached targeted individuals. Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment. When the maximum number of visited households across all campaign rounds was used as the numerator, program reach for at least one visit would have been 86.4% (95% CI: 80.8-92.0) in MDA and 83.5% (95% CI: 78.0-89.1) in fMDA trial arms. As per the protocol, the trial provided dihydroartemisinin-piperaquine treatment to an average of 58.8% and 13.3% of the estimated population based on capture-recapture in MDA and fMDA, respectively, across the four rounds.",2020,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","['Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia', 'eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000']",['MDA or focal MDA (fMDA)-where treatment'],[],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.101887,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0665']
1190,32618265,"Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia.","From December 2014 to February 2016, a cluster randomized controlled trial was carried out in 60 health facility catchment areas along Lake Kariba in Zambia's Southern Province. The trial sought to evaluate the impact of four rounds of a mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP at the household level compared with a control population that received the standard of care. This study was the first randomized controlled trial with DHAP for MDA in sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University. This article serves as an introduction to a collection of articles designed to explore different aspects of the intervention. By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.",2020,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","['sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University', ""60 health facility catchment areas along Lake Kariba in Zambia's Southern Province"", 'Southern Province, Zambia']","['Elimination', 'DHAP', 'mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP']",[],"[{'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",[],,0.0505108,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Maya S', 'Initials': 'MS', 'LastName': 'Fraser', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Lewis', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0669']
1191,32588803,Use of Typhoid Vi-Polysaccharide Vaccine as a Vaccine Probe to Delineate Clinical Criteria for Typhoid Fever.,"Blood cultures (BCs) detect an estimated 50% of typhoid fever cases. There is need for validated clinical criteria to define cases that are BC negative, both to help direct empiric antibiotic treatment and to better evaluate the magnitude of protection conferred by typhoid vaccines. To derive and validate a clinical rule for defining BC-negative typhoid fever, we assessed, in a cluster-randomized effectiveness trial of Vi-polysaccharide (ViPS) typhoid vaccine in Kolkata, India, 14,797 episodes of fever lasting at least 3 days during 4 years of comprehensive, BC-based surveillance of 70,865 persons. A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%. To validate this rule as a definition for BC-negative typhoid fever, we assessed whether the rule defined culture-negative syndromes prevented by ViPS vaccine. In a training subset of individuals, we identified the following two rules: rule 1: patients aged < 15 years with prolonged fever accompanied by a measured body temperature ≥ 100°F, headache, and nausea; rule 2: patients aged ≥ 15 years with prolonged fever accompanied by nausea and palpable liver but without constipation. The adjusted protective efficacy of ViPS against clinical typhoid defined by these rules in persons aged ≥ 2 years in a separate validation subset was 33% (95% CI: 4-53%). We have defined and validated a clinical rule for predicting BC-negative typhoid fever using a novel vaccine probe approach. If validated in other settings, this rule may be useful to guide clinical care and to enhance typhoid vaccine evaluations.",2020,A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%.,"['patients aged < 15 years with prolonged fever accompanied by a measured body temperature ≥ 100°F, headache, and nausea; rule 2: patients aged ≥ 15 years with prolonged fever accompanied by nausea and palpable liver but without constipation', 'Kolkata, India, 14,797 episodes of fever lasting at least 3 days during 4 years of comprehensive, BC-based surveillance of 70,865 persons']","['Typhoid Vi-Polysaccharide Vaccine', 'Vi-polysaccharide (ViPS) typhoid vaccine', 'ViPS']",['Blood cultures (BCs) detect'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0577045', 'cui_str': 'Liver palpable'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0078221', 'cui_str': 'Typhoid Vi Polysaccharide Vaccine, S typhi Ty2 strain'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}]","[{'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",,0.333085,A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%.,"[{'ForeName': 'Md Taufiqul', 'Initials': 'MT', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Im', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ahmmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'Korea University College of Medicine, Seoul, South Korea.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0968']
1192,32589939,Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.,"PURPOSE


We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity.
PATIENTS AND METHODS


This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery.
RESULTS


Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
CONCLUSIONS


A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.",2020,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","['patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity', 'adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis', 'patients with bilateral mandibular fracture', '315 patients enrolled', 'Bilateral Mandibular Fractures']","['rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation', 'nonrigid fixation group', 'rigid and nonrigid fixation', 'Rigid and Nonrigid Fixation Versus Nonrigid Fixation']","['complication rates', 'Helkimo dysfunction index and mandibular mobility index', 'complication risk', 'overall complication rate', 'complications within 6\xa0weeks after surgery', 'complication rate', 'complications within 3\xa0months, Helkimo dysfunction index, and mandibular mobility', 'complication rates and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",315.0,0.151617,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","[{'ForeName': 'Vivesh', 'Initials': 'V', 'LastName': 'Rughubar', 'Affiliation': 'Head, Clinical Unit, Maxillofacial and Oral Surgery, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Vares', 'Affiliation': 'Professor, Head, and Chair of Surgical Dentistry & Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Priyadeshni', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Dentist, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Filipsky', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Creanga', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Hospital Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Alkhalil', 'Affiliation': 'Head, Department Oral and Maxillofacial Surgery and CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Kormi', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Päijät-Häme Central Hospital, Päijät-Häme Joint Authority of Health and Wellbeing, Lahti, Finland (currently), and, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hanken', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Asklepios Hospital North, Faculty of Medicine, Semmelweis University Campus Hamburg, Hamburg, Germany (currently), and Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alvaro Rivero', 'Initials': 'AR', 'LastName': 'Calle', 'Affiliation': 'Consultant, Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Wenko', 'Initials': 'W', 'LastName': 'Smolka', 'Affiliation': 'Senior Surgeon, Department of Oral & Maxillofacial Surgery, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Chief of Oral and Maxillofacial Surgery, Division of Oral and Maxillofacial Surgery, Mount Sinai Hospital, New York City, NY.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csáki', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Ministry of Defense Health Centre, Budapest, Hungary.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Sánchez-Aniceto', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez', 'Affiliation': 'Associate Professor and Program Director, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carl-Peter', 'Initials': 'CP', 'LastName': 'Cornelius', 'Affiliation': 'Associate Professor, Ludwig-Maximilians University, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie, Munich, Germany.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alani', 'Affiliation': 'Specialist, CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vlad', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kontio', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Professor and Chair of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX. Electronic address: ellise3@uthscsa.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.012']
1193,32591439,"Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment: The Systolic Blood Pressure Intervention Trial.","BACKGROUND


Intensively treating hypertension may benefit cardiovascular disease and cognitive function, but at the short-term expense of reduced kidney function.
METHODS


We investigated markers of kidney function and the effect of intensive hypertension treatment on incidence of dementia and mild cognitive impairment (MCI) in 9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively). We categorized participants according to baseline and longitudinal changes in eGFR and urinary albumin-to-creatinine ratio. Primary outcomes were occurrence of adjudicated probable dementia and MCI.
RESULTS


Among 8563 participants who completed at least one cognitive assessment during follow-up (median 5.1 years), probable dementia occurred in 325 (3.8%) and MCI in 640 (7.6%) participants. In multivariable adjusted analyses, there was no significant association between baseline eGFR <60 ml/min per 1.73 m 2  and risk for dementia or MCI. In time-varying analyses, eGFR decline ≥30% was associated with a higher risk for probable dementia. Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI. Although these kidney events occurred more frequently in the intensive treatment group, there was no evidence that they modified or attenuated the effect of intensive treatment on dementia and MCI incidence. Baseline and incident urinary ACR ≥30 mg/g were not associated with probable dementia or MCI, nor did the urinary ACR modify the effect of intensive treatment on cognitive outcomes.
CONCLUSIONS


Among hypertensive adults, declining kidney function measured by eGFR is associated with increased risk for probable dementia and MCI, independent of the intensity of hypertension treatment.",2020,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"['hypertensive adults', '8563 participants who completed at least one', 'Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment', '9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively']",['intensive hypertension treatment'],"['incidence of dementia and mild cognitive impairment (MCI', 'eGFR and urinary albumin-to-creatinine ratio', 'dementia and MCI incidence', 'cognitive assessment', 'kidney events', 'probable dementia', 'occurrence of adjudicated probable dementia and MCI']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",9361.0,0.140303,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Geriatric Research and Education Clinical Center, Palo Alto VA Health Care System, Palo Alto, California mktamura@stanford.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Chelune', 'Affiliation': ""Center for Alzheimer's Care, Imaging and Research, University of Utah School of Medicine, Salt Lake City, Utah.""}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Departments of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention and Division of Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020010038']
1194,32598468,Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.,"INTRODUCTION


Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse.
METHODS


Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse.
RESULTS


By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-""lapse"" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks.
CONCLUSIONS


In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts.
IMPLICATIONS


This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01120704.",2020,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","['Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with non-lapsers (n=146 pairs) on multiple variables', 'Participants (N=416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD']","['nicotine replacement therapy (NRT', 'nicotine patch plus nicotine gum post-TQD', 'nicotine patch plus gum, lapsers versus matched non-lapsers']",['Univariate survival analyses'],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",416.0,0.00852757,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","[{'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bolt', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hayes-Birchler', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa116']
1195,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial.,"Rationale:  Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin concentrations may identify patients most likely to benefit from such therapy. Objectives:  To test the kinetic changes in renin concentrations and their prognostic value in patients with CRVS. Methods:  We analyzed serum samples from patients enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial for renin, angiotensin I, and angiotensin II concentrations before the start of administration of angiotensin II or placebo and after 3 hours. Measurements and Main Results:  Baseline serum renin concentration (normal range, 2.13-58.78 pg/ml) was above the upper limits of normal in 194 of 255 (76%) study patients with a median renin concentration of 172.7 pg/ml (interquartile range [IQR], 60.7 to 440.6 pg/ml), approximately threefold higher than the upper limit of normal. Renin concentrations correlated positively with angiotensin I/II ratios ( r  = 0.39;  P  < 0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR, 37.9% to 66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR, 37.6% reduction to 5.1% increase) with placebo ( P  < 0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28 of 55 (50.9%) patients compared with 51 of 73 patients (69.9%) treated with placebo (unstratified hazard ratio, 0.56; 95% confidence interval, 0.35 to 0.88;  P  = 0.012) ( P  = 0.048 for the interaction). Conclusions:  The serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes.Clinical trial registered with www.clinicaltrials.gov (NCT02338843).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Unit, Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, and.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, School of Medicine, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care, Regions Hospital, University of Minnesota, St. Paul, Minnesota.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'Division of Critical Care, Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, School of Medicine, University of California-Davis, Northern California Health System, Mather, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Renal Division, Department of Medicine, Emory University Medical Center, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, Guy's & St. Thomas' Hospital, King's College London, London, United Kingdom.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC']
1196,32611505,Treatment Rationale and Design of a Phase III Study of Afatinib or Chemotherapy in Patients with Non-small-cell Lung Cancer Harboring Sensitizing Uncommon Epidermal Growth Factor Receptor Mutations (ACHILLES/TORG1834).,"We describe the treatment rationale and design of our randomized phase III study, the ACHILLES trial (Japan Registry of Clinical Trials: jRCTs031180175). The aim of this study is to investigate the superiority of afatinib over chemotherapy as first-line treatment in patients with advanced nonsquamous non-small-cell lung cancer with sensitizing uncommon or compound epidermal growth factor receptor (EGFR) mutations, with the exception of de novo T790M mutations and exon 20 insertions. Eligible patients will be randomized at a 1:2 ratio to receive either chemotherapy or afatinib until disease progression or unacceptable toxicity. Patients in the chemotherapy arm will receive pemetrexed 500 mg/m 2  + cisplatin 75 mg/m 2  or carboplatin area under the curve (AUC) 5 or 6 every 3 weeks × 4 cycles, followed by pemetrexed 500 mg/m 2  every 3 weeks. In the afatinib arm, investigators will choose the starting dose of afatinib (30 mg or 40 mg orally daily). The primary endpoint is progression-free survival. A total of 106 patients will be enrolled in this trial over a 30-month registration period with a 15-month follow-up. Enrollment began in March 2019. The results of this trial will establish the superiority of afatinib over chemotherapy in a cohort with a large variety of EGFR mutations.",2020,The primary endpoint is progression-free survival.,"['Patients with Non-small-cell Lung Cancer Harboring', 'patients with advanced nonsquamous non-small-cell lung cancer with sensitizing uncommon or compound epidermal growth factor receptor (EGFR) mutations, with the exception of de novo T790M mutations and exon 20 insertions', '106 patients will be enrolled in this trial over a 30-month registration period with a 15-month follow-up', 'Eligible patients']","['afatinib over chemotherapy', 'chemotherapy or afatinib until disease progression or unacceptable toxicity', 'pemetrexed 500 mg/m 2 \xa0+ cisplatin 75 mg/m 2  or carboplatin', 'Afatinib or Chemotherapy']",['progression-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",106.0,0.101737,The primary endpoint is progression-free survival.,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. Electronic address: miusat1118@niigata-cc.jp.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Eiki', 'Initials': 'E', 'LastName': 'Ichihara', 'Affiliation': 'Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kanazu', 'Affiliation': 'Department of Thoracic Oncology, Osaka Toneyama Medical Center, Osaka, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University Hospital, Aichi, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.05.011']
1197,32615488,Effects of the juçara fruit supplementation on metabolic parameters in individuals with obesity: a double-blind randomized controlled trial.,"Adipose tissue inflammation has been proposed as a central mechanism connecting obesity with its metabolic and vascular complications due to the imbalance in the expression of several hormones and adipokines. Berries rich in polyphenols and unsaturated fatty acids have been able to prevent both obesity and adipose tissue inflammation, improving metabolic functions in human subjects and animal models of obesity. Juçara has been considered a super fruit owing to its nutritional composition and relevant biological activities with an interesting response in animals. Thus, we aimed to verify the potential antiobesogenic effect of juçara supplementation in humans. We conducted a double-blind, placebo-controlled, randomized trial with 35 adults with obesity of both sexes. They were assessed for resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines. Subsequently, they were randomized into two groups to use or not (placebo) 5 g lyophilized juçara for 6 weeks. Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin. Besides, juçara supplementation, high-density lipoprotein cholesterol and neck circumference were predictors to explain the enhancement in adiponectin. Juçara supplementation was determinant to improve adiponectin levels, and it may be considered a novel strategy for the treatment of obesity-related metabolic diseases.",2020,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","['35 adults with obesity of both sexes', 'individuals with obesity', 'humans']","['juçara fruit supplementation', 'juçara supplementation', 'not (placebo', 'placebo']","['body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin', 'resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines', 'juçara supplementation, high-density lipoprotein cholesterol and neck circumference', 'metabolic parameters', 'adiponectin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",35.0,0.113597,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","[{'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Flygare', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Departamento de Medicina Cardiovascular, Angiocorpore Instituto de Medicina Cardiovascular, Santos, SP, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil; Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil. Electronic address: lucianapisani@gmail.com.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108430']
1198,32618267,"Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and  Plasmodium falciparum  Clearance in Southern Province, Zambia.","Mass drug administration (MDA) with artemisinin combination therapy is a potentially useful tool for malaria elimination programs, but its success depends partly on drug effectiveness and treatment coverage in the targeted population. As part of a cluster-randomized controlled trial in Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with dihydroartemisinin-piperaquine (DHAp), sub-studies were conducted investigating population drug adherence rates and effectiveness of DHAp as administered in clearing  Plasmodium falciparum  infections following household mass administration. Adherence information was reported for 181,534 of 336,821 DHAp (53.9%) treatments administered during four rounds of MDA/fMDA, of which 153,197 (84.4%) reported completing the full course of DHAp. The proportion of participants fully adhering to the treatment regimen differed by MDA modality (MDA versus fMDA), RDT status, and whether the first dose was observed by those administering treatments. Among a subset of participants receiving DHAp and selected for longitudinal follow-up, 58 were positive for asexual-stage  P. falciparum  infection by microscopy at baseline. None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia. For those with longer term follow-up, one participant was positive 47 days after treatment, and two additional participants were positive after 69 days, although these two were determined to be new infections by genotyping. High completion of a 3-day course of DHAp and parasite clearance in the context of household MDA are promising as Zambia's National Malaria Programme continues to weigh appropriate interventions for malaria elimination.",2020,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"['Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with', 'Southern Province, Zambia']","['Dihydroartemisinin-Piperaquine', 'DHAp', 'artemisinin combination therapy', 'dihydroartemisinin-piperaquine (DHAp']","['Adherence information', 'MDA modality (MDA versus fMDA), RDT status', 'slide positive for asexual-stage parasitemia']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}]",,0.179382,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital Grounds, Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Daniels', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Volkman', 'Affiliation': 'Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0667']
1199,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1200,32619648,Impact of compliance to chemoradiation on long-term outcomes in squamous cell carcinoma of the anus: results of a post hoc analysis from the randomised phase III ACT II trial.,"BACKGROUND


Concurrent chemoradiation is standard-of-care for patients with squamous cell carcinoma of the anus. Poor compliance to chemotherapy, radiotherapy treatment interruptions and unplanned breaks may impact adversely on long-term outcomes.
METHODS


The ACT II trial recruited 940 patients with localised squamous cell carcinoma of the anus, and assigned patients to mitomycin (week 1) or cisplatin (weeks 1 and 5), with fluorouracil (weeks 1 and 5) and radiotherapy (50.4 Gy in 28 fractions over 38 days). This post hoc analysis examined the association between baseline factors (age, gender, site, T stage and N stage), and compliance to treatment (radiotherapy and chemotherapy), and their effects on locoregional failure-free survival, progression-free survival (PFS) and overall survival (OS). Compliance was categorised into groups. Radiotherapy: six groups according to total dose and overall treatment time (OTT). Chemotherapy: three groups (A = per-protocol; B = dose reduction or delay; C = omitted).
RESULTS


A total of 931/940 patients were assessable for radiotherapy and 936 for chemotherapy compliance. Baseline glomerular filtration rate <60 ml/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (P = 0.003 and 0.02, respectively). Omission of week 5 chemotherapy was associated with significantly worse locoregional failure-free survival [hazard ratio (HR) 2.53 (1.33-4.82) P = 0.005]. Dose reductions/delays or omission of week 5 chemotherapy were associated with significantly worse PFS {HR: 1.56 [95% confidence interval (CI): 1.18-2.06], P = 0.002 and HR: 2.39 (95% CI: 1.44-3.98), P = 0.001, respectively} and OS [HR: 1.92 (95% CI: 1.41-2.63), P < 0.001 and HR: 2.88 (95% CI: 1.63-5.08), P < 0.001, respectively]. Receiving the target radiotherapy dose in >42 days is associated with worse PFS and OS [HR: 1.72 (95% CI: 1.17-2.54), P =0.006].
CONCLUSION


Poor compliance to chemotherapy and radiotherapy were associated with worse locoregional failure-free survival, PFS and OS. Treatment interruptions should be minimised, and OTT and total dose maintained.
CLINICAL TRIAL NUMBER


ISRCTN 26715889.",2020,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","['patients with squamous cell carcinoma of the anus (SCCA', '940 patients with localized SCCA, and assigned patients to', 'squamous cell carcinoma of the anus', '931/940 patients were evaluable for radiotherapy and 936 for chemotherapy compliance']","['Chemotherapy', 'chemotherapy and radiotherapy', 'fluorouracil', 'chemotherapy, radiotherapy', 'cisplatin', 'mitomycin', 'radiotherapy (50·4Gy', 'Radiotherapy']","['worse PFS and OS', 'total dose (TD) and overall treatment time (OTT', 'loco-regional failure-free survival (LRFFS), progression-free survival (PFS) and overall survival (OS', 'Baseline Glomerular filtration rate (GR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1412036', 'cui_str': 'Anal squamous cell carcinoma'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",940.0,0.148641,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, UK. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Meadows', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'Oxford Cancer & Haematology Centre, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'University of Leeds, Leeds Cancer Centre, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.012']
1201,32621543,Pharmacokinetics of the Monoclonal Antibody MHAA4549A Administered in Combination With Oseltamivir in Patients Hospitalized With Severe Influenza A Infection.,"MHAA4549A is a human anti-influenza A monoclonal antibody developed to treat influenza A. We report MHAA4549A serum, nasopharyngeal, and tracheal aspirate pharmacokinetics from a phase 2b study in hospitalized patients with severe influenza A. Patients were randomized 1:1:1 into 3 groups receiving single intravenous doses of 3600 mg (n = 55) or 8400 mg (n = 47) MHAA4549A or placebo (n = 56). Patients also received oral oseltamivir twice daily for ≥5 days. Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples were collected on days 1-60 from MHAA4549A-treated groups. Day 5 plasma samples from all groups were collected for assessing the pharmacokinetics of oseltamivir and its active metabolite, oseltamivir carboxylate. Noncompartmental pharmacokinetic analysis was performed using Phoenix WinNonlin. Data were collected during a preplanned interim analysis that became final when the trial terminated because of a lack of efficacy. Serum MHAA4549A concentrations were dose-proportional and biphasic. Mean MHAA4549A clearance was 288-350 mL/day, and mean half-life was 17.8-19.0 days. Nasopharyngeal MHAA4549A concentrations were non-dose-proportional. We detected MHAA4549A in tracheal aspirate samples, but intersubject variability was high. MHAA4549A serum and nasopharyngeal exposures were confirmed in all MHAA4549A-treated patients. Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects. MHAA4549A detection in tracheal aspirate samples indicated exposure in the lower respiratory tract. Oseltamivir and oseltamivir carboxylate exposures were similar between MHAA4549A-treated and placebo groups, suggesting a lack of MHAA4549A interference with oseltamivir pharmacokinetics.",2020,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"['Patients Hospitalized With Severe Influenza A Infection', 'hospitalized patients with severe influenza A. Patients']","['MHAA4549A-treated and placebo', 'oral oseltamivir', 'Monoclonal Antibody MHAA4549A', 'MHAA4549A', 'MHAA4549A or placebo']","['Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples', 'MHAA4549A serum and nasopharyngeal exposures', 'Serum MHAA4549A concentrations', 'Mean MHAA4549A clearance', 'Nasopharyngeal MHAA4549A concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C2919642', 'cui_str': 'Specimen from trachea obtained by aspiration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.04558,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Gaohong', 'Initials': 'G', 'LastName': 'She', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Hanley', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1652']
1202,32683992,Monopolar dielectric diathermy by emission of radiofrequency in Patellofemoral pain. A single-blind-randomized clinical trial.,"Despite the high incidence of patellofemoral pain syndrome (PFPS), few studies show the effects of radiofrequency on pain and functionality in these patients. For this reason, the aim of this study was to determine the efficacy of monopolar dielectric diathermy by emission of radiofrequency (MDR) in dynamic applications aimed at treating pain and improving function in patients with PFPS. For this purpose, a single-blind randomized clinical trial was conducted. Eighty-four participants with PFPS were evenly divided into an experimental group (EG) and a control group (CG). All subjects receive 10 min of daily home exercises along 3 weeks, and in addition, the subjects of the EG received 10 sessions based on the dynamic application of MDR. Variables measured included Visual Analogue Scale (VAS), DN4 questionnaire, Lower Extremity Functionality Scale (LEFS), Kujala scale, Range of Movement (ROM) in knee flexion and extension and drug intake. The EG showed a statistically significant reduction in pain (VAS = 4.8 [5.5-4.1] [ p  < .001]; DN4 = 3.8 [4.4-3.2] [ p  < .001]), and an increase in functionality (LEFS = 16 [19-13] [ p  < .001]; Kujala = 19 [23-14] [ p  < .001]) and in ROM (flexion 18º [21º-16º] [ p  < .001]). No statistically significant changes in drug intake were found. Based on this data, the dynamic application of MDR seems effective in reducing pain and increasing functionality and flexion in patients with PFPS. Diathermy by emission of radiofrequency could be recommended as complement or main therapy in the treatment of PFPS.",2020,The EG showed a statistically significant reduction in pain (VAS = 4.8 [5.5-4.1] [ p  < .001],"['patients with PFPS', 'Eighty-four participants with PFPS', 'Patellofemoral pain']","['Monopolar dielectric diathermy by emission of radiofrequency', 'monopolar dielectric diathermy by emission of radiofrequency (MDR', 'radiofrequency']","['pain and increasing functionality and flexion', 'drug intake', 'pain', 'Visual Analogue Scale (VAS), DN4 questionnaire, Lower Extremity Functionality Scale (LEFS), Kujala scale, Range of Movement (ROM) in knee flexion and extension and drug intake', 'pain and functionality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0242640', 'cui_str': 'Multiple-drug resistance'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",84.0,0.0504602,The EG showed a statistically significant reduction in pain (VAS = 4.8 [5.5-4.1] [ p  < .001],"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Physiotherapy Department, University of Seville , Seville, Spain.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Health Sciences Department, University of Jaen , Jaen, Spain.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Physiotherapy Department, University of Granada , Granada, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Espejo-Antúnez', 'Affiliation': 'Department of Medical-Surgical Therapy, University of Extremadura , Badajoz, Spain.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1793169']
1203,32602616,Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial.,"Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.",2020,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","['Liver Transplant Immune Suppression', 'From July 2017 to November 2018, twenty subjects undergoing first LT received']","['prednisone', 'Budesonide', 'budesonide immunosuppressive therapy', 'budesonide', 'calcineurin inhibitors and mycophenolate']","['rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications', 'Safety and Efficacy', 'safety and efficacy', 'toxicity-therapeutic ratio', 'Rates of ACR']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",20.0,0.0575914,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Bari', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Shimul A', 'Initials': 'SA', 'LastName': 'Shah', 'Affiliation': 'Division of, Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Kaiser', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Transplant Surgery, Department of Surgery, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleesattel', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25837']
1204,32603526,Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for Treatment of Anemia in Chronic Kidney Disease: A Placebo-Controlled Study of Pharmacokinetic and Pharmacodynamic Profiles in Hemodialysis Patients.,"Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study in patients with end-stage renal disease with anemia on hemodialysis. Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10 g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind placebo-controlled study. Two cohorts were randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2 mg/kg) or placebo 1 hour after hemodialysis on day 1 and 2 hours before dialysis on day 8. Maximum plasma concentration and area under the plasma concentration-time curve for patients receiving roxadustat were slightly more than dose proportional and elimination half-life ranged from 14.7 to 19.4 hours. Roxadustat was highly protein bound (99%) in plasma, and dialysis contributed a small fraction of the total clearance: only 4.56% and 3.04% of roxadustat recovered from the 1 and 2 mg/kg dose groups, respectively. Roxadustat induced transient elevations of endogenous erythropoietin that peaked between 7 and 14 hours after dosing and returned to baseline by 48 hours after dosing. Peak median endogenous erythropoietin levels were 96 mIU/mL and 268 mIU/mL for the 1- and 2-mg/kg doses, respectively, within physiologic range of endogenous erythropoietin responses to hypoxia at high altitude or after blood loss. No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.",2020,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","['Chronic Kidney Disease', 'Hemodialysis Patients', 'patients with end-stage renal disease with anemia on hemodialysis', 'Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10\xa0g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind']","['Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor', 'Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592', 'Placebo', 'placebo']","['Peak median endogenous erythropoietin levels', 'serious adverse events', 'transient elevations of endogenous erythropoietin', 'Maximum plasma concentration and area under the plasma concentration-time curve']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3713379', 'cui_str': 'FG-4592'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3658210', 'cui_str': 'Proline Hydroxylase Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2.0,0.0875764,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Provenzano', 'Affiliation': 'Department of Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Southeast Renal Research Institute, Chattanooga, Tennessee, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Zabaneh', 'Affiliation': 'Northwest Louisiana Nephrology Research, Shreveport, Louisiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chou', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hemmerich', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Neff', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'K-H Peony', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1648']
1205,32612194,Sub-maximal endurance exercise does not mediate alterations of somatosensory thresholds.,"Physical exercise has been shown to alter sensory functions, such as sensory detection or perceived pain. However, most contributing studies rely on the assessment of single thresholds, and a systematic testing of the sensory system is missing. This randomised, controlled cross-over study aims to determine the sensory phenotype of healthy young participants and to assess if sub-maximal endurance exercise can impact it. We investigated the effects of a single bout of sub-maximal running exercise (30 min at 80% heart rate reserve) compared to a resting control in 20 healthy participants. The sensory profile was assessed applying quantitative sensory testing (QST) according to the protocol of the German Research Network on Neuropathic Pain. QST comprises a broad spectrum of thermal and mechanical detection and pain thresholds. It was applied to the forehead of study participants prior and immediately after the intervention. Time between cross-over sessions was one week. Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds. The sensory phenotypes did not indicate any clinically meaningful deviation of sensory function. The alteration of sensory thresholds needs to be carefully interpreted, and only systematic testing allows an improved understanding of mechanism. In this context, sub-maximal endurance exercise is not followed by a change of thermal and mechanical sensory function at the forehead in healthy volunteers.",2020,Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds.,"['healthy young participants', 'healthy volunteers', '20 healthy participants']","['Sub-maximal endurance exercise', 'sub-maximal endurance exercise', 'sub-maximal running exercise', 'Physical exercise', 'QST']",['thermal or mechanical sensory function'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",20.0,0.0441582,Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds.,"[{'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Kortenjann', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany. Johannes.fleckenstein@sport.uni-frankfurt.de.'}]",Scientific reports,['10.1038/s41598-020-67700-4']
1206,32618134,Effect of melatonin on heart failure: design for a double-blinded randomized clinical trial.,"AIMS


Current studies indicate that melatonin can counteract renin-angiotensin-aldosterone system and sympathetic over activity in heart failure (HF) and might have a protective and repairing effect on cardiovascular injuries, skeletal muscle weakness, and metabolic abnormalities, which are common pathological processes in patients with HF. The MeHR trial (Melatonin for Heart Failure with Reduced Ejection Fraction) aims to evaluate the effect of oral melatonin on myocardial, skeletal muscle, and metabolic dysfunctions in HF, which leads to lower quality of life and increased morbidity and mortality in these patients.
METHODS AND RESULTS


This is a double-blind randomized clinical trial with two parallel arms of 1:1 allocation, which recruits 90 outpatients with HF with reduced ejection fraction. Participants receive 10 mg tablets of melatonin or placebo for 24 weeks. The primary outcomes are changes in echocardiographic indexes of HF and serum levels of N terminal pro brain natriuretic peptide. Secondary outcome is a composite clinical endpoint score including all-cause mortality, hospitalization for HF, and change in the quality of life during the study. Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism. Statistical analysis will include simple unadjusted analyses for the detection of differences between groups and changes in outcomes and also a generalized linear mixed model to explore potential associations between outcomes and participant characteristics.
CONCLUSIONS


The results of this comprehensive study might elucidate the safety of oral melatonin in patients with HF and provide some evidence on its effectiveness as an adjunctive therapy to enhance the well-being of these patients.",2020,"Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism.","['patients with HF', 'heart failure (HF', '90 outpatients with HF with reduced ejection fraction']","['melatonin or placebo', 'melatonin', 'oral melatonin']","['myocardial, skeletal muscle, and metabolic dysfunctions', 'composite clinical endpoint score including all-cause mortality, hospitalization for HF, and change in the quality of life', 'changes in echocardiographic indexes of HF and serum levels of N terminal pro brain natriuretic peptide', 'heart failure', 'adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",90.0,0.60701,"Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Khosrawi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Kiyan', 'Initials': 'K', 'LastName': 'Heshmat-Ghahdarijani', 'Affiliation': 'Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Yousof', 'Initials': 'Y', 'LastName': 'Gheisari', 'Affiliation': 'Regenerative Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mansoorian', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shervin Ghaffari', 'Initials': 'SG', 'LastName': 'Hoseini', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",ESC heart failure,['10.1002/ehf2.12829']
1207,32628250,Comparison of As-Needed and Scheduled Posthospitalization Follow-up for Children Hospitalized for Bronchiolitis: The Bronchiolitis Follow-up Intervention Trial (BeneFIT) Randomized Clinical Trial.,"Importance


Posthospitalization follow-up visits are prescribed frequently for children with bronchiolitis. The rationale for this practice is unclear, but prior work has indicated that families value these visits for the reassurance provided. The overall risks and benefits of scheduled visits have not been evaluated.
Objective


To assess whether an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing anxiety among parents of children hospitalized for bronchiolitis.
Design, Setting, and Participants


This open-label, noninferiority randomized clinical trial, performed between January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California). Data analysis was performed in an intention-to-treat manner.
Interventions


Randomization (1:1) to a scheduled (n = 151) vs an as-needed (n = 153) posthospitalization follow-up visit.
Main Outcome and Measures


The primary outcome was parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale, which ranged from 0 to 28 points, with higher scores indicating greater anxiety. Fourteen prespecified secondary outcomes were assessed.
Results


Among 304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88%). A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%). The mean (SD) 7-day parental anxiety score was 3.9 (3.5) among the as-needed posthospitalization follow-up group and 4.2 (3.5) among the scheduled group (absolute difference, -0.3 points; 95% CI, -1.0 to 0.4 points), with the upper bound of the 95% CI within the prespecified noninferiority margin of 1.1 points. Aside from a decreased mean number of clinic visits (absolute difference, -0.6 visits per patient; 95% CI, -0.4 to -0.8 visits per patient) among the as-needed group, there were no significant between-group differences in secondary outcomes, including readmissions (any hospital readmission before symptom resolution: absolute difference, -1.6%; 95% CI, -5.7% to 2.5%) and symptom duration (time from discharge to cough resolution: absolute difference, -0.6 days; 95% CI, -2.4 to 1.2 days; time from discharge to child reported ""back to normal"": absolute difference, -0.8 days; 95% CI, -2.7 to 1.0 days; and time from discharge to symptom resolution: absolute difference, -0.6 days; 95% CI, -2.5 to 1.3 days).
Conclusions and Relevance


Among parents of children hospitalized for bronchiolitis, an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing parental anxiety. These findings support as-needed follow-up as an effective posthospitalization follow-up strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03354325.",2020,"A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%).","['Children Hospitalized for Bronchiolitis', 'children with bronchiolitis', ""January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California"", 'parents of children hospitalized for bronchiolitis', '304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88']",[],"['mean number of clinic visits', 'parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale', 'anxiety', 'mean (SD) 7-day parental anxiety score', 'readmissions (any hospital readmission', 'symptom duration']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",304.0,0.180099,"A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%).","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Coon', 'Affiliation': ""Department of Pediatrics, Primary Children's Hospital, University of Utah School of Medicine, Salt Lake City.""}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Destino', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vukin', 'Affiliation': ""Department of Pediatrics, Primary Children's Hospital, University of Utah School of Medicine, Salt Lake City.""}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Stoddard', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schroeder', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.1937']
1208,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1209,32632661,Correction to: No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".",2020,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","['percutaneous palliation of malignant hilar biliary obstruction', 'malignant hilar biliary obstruction']",[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}]",[],[],,0.0447173,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-020-07029-8']
1210,32631261,Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial.,"BACKGROUND


A high number of patients with obsessive-compulsive disorder (OCD) do not receive cognitive-behavioral therapy with exposure and response prevention, which is the most effective treatment for OCD. Therefore, Metacognitive Training for OCD (MCT-OCD) was developed, which is a structured group therapy aiming at the modification of dysfunctional (meta-)cognitive biases, beliefs and coping styles. It can be administered by less trained personnel, thus may reach a higher number of patients. An uncontrolled pilot study (MCT-OCD pilot version) provided first evidence that the training is highly accepted by patients; OC symptoms decreased with a high effect size (η 2 partial  = 0.50). The aim of the present study is to address the shortcomings of the pilot study (e.g., no control group) and to assess the efficacy of the revised version of the MCT-OCD in the framework of a randomized controlled trial.
METHODS


Eighty patients with OCD will be recruited. After a blinded assessment at baseline (-t1), patients will be randomly assigned either to the intervention group (MCT-OCD; n = 40) or to a care as usual control group (n = 40). The MCT-OCD aims to enhance patients' metacognitive competence in eight modules by addressing dysfunctional (meta-)cognitive biases and beliefs associated with OCD (e.g., intolerance of uncertainty). After 8 weeks, patients will be invited to a post assessment (t1), and then they will receive a follow-up online questionnaire 3 months following t1 (t2). The primary outcome is the Y-BOCS total score, and the secondary outcomes include the HDRS, OCI-R, OBQ-44, MCQ-30, WHOQOL-BREF, BDI-II, and subjective appraisal ratings of the MCT-OCD. We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
DISCUSSION


The planned study is the first to investigate the MCT-OCD, a promising new treatment, in a randomized controlled trial. The MCT-OCD may help to overcome existing treatment barriers for patients with OCD.
TRIAL REGISTRATION


German Registry for Clinical Studies ( DRKS00013539 ), 22.02.2018.",2020,"We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
","['patients with OCD', 'Eighty patients with OCD will be recruited', 'patients with obsessive-compulsive disorder (OCD', 'Obsessive-Compulsive Disorder']","['intervention group (MCT-OCD; n\u2009=\u200940) or to a care as usual\xa0control group', 'MCT-OCD', 'Metacognitive Training for OCD (MCT-OCD', 'Metacognitive Training']","['Y-BOCS total score', 'HDRS, OCI-R, OBQ-44, MCQ-30, WHOQOL-BREF, BDI-II, and subjective appraisal ratings of the MCT-OCD', 'OC symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0684043', 'cui_str': 'Occitan language'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.0874827,"We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Miegel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. f.miegel@uke.de.'}, {'ForeName': 'Cüneyt', 'Initials': 'C', 'LastName': 'Demiralay', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02648-3']
1211,32631795,Nurse-led mind-body relaxation intervention in prison: A multiperspective mixed-method evaluation.,"BACKGROUND


Mind-body relaxation techniques are complementary or alternative to medication to manage high stress and anxiety levels in prisons.
PURPOSE


To assess the motivation to attend and perceived benefits of a nurse-led group relaxation intervention in prison, investigate the experience of participants, prison officers, and health professionals, and identify improvements.
METHOD


Exploratory study was conducted in a post-trial facility in Switzerland using a multiperspective convergent parallel mixed method drawing from participatory action research principles.
FINDINGS


Reasons for attendance included back problems, mental tension, physical fitness, relaxation, and sleep problems. Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness. Qualitative findings converged highlighting the importance of body-centering, relaxation as an alternative to medication, negative representations about relaxation sessions (useless, effeminate), and recommendations for improvement, including audio-visual support for self-practice.
DISCUSSION


Long-standing mind-body relaxation interventions led by nurses in groups may offer participants a beneficial and operationally feasible complement to stress management in prisons.",2020,"Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness.","['Exploratory study was conducted in a post-trial facility in Switzerland using a multiperspective convergent parallel mixed method drawing from participatory action research principles', 'prison']","['Nurse-led mind-body relaxation intervention', 'nurse-led group relaxation intervention']","['back problems, mental tension, physical fitness, relaxation, and sleep problems', 'physical tensions and anxiety, and improvement of sleep and physical fitness']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0001273', 'cui_str': 'Action Research'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0579085', 'cui_str': 'Back problem'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0227782,"Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness.","[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Pralong', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Renaud', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Anne-Dominique', 'Initials': 'AD', 'LastName': 'Secretan', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Marysette', 'Initials': 'M', 'LastName': 'Blanc', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Charmillot', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Mouton', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wolff', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia. Electronic address: Nguyen-Toan.Tran@unige.ch.'}]",Nursing outlook,['10.1016/j.outlook.2020.05.005']
1212,32639545,Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial.,"Importance


Gynecological laparoscopies are one of the most common surgical procedures worldwide. Limited evidence exists on rates of surgical site infections in patients undergoing gynecological laparoscopies and strategies to prevent these infections.
Objective


To compare rates of port-site infections, organ or space infections, and any type of surgical site infections among patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions.
Design, Setting, and Participants


A double-blind randomized clinical trial was conducted between February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center. A total of 661 patients 18 years or older who underwent an elective operative laparoscopy for treatment of nonmalignant gynecological disorders were randomly assigned in a 1:1:1 ratio to have their skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine. Statistical analysis was performed from February 28, 2017, to November 26, 2018. Analyses were performed on a modified intention-to-treat basis.
Interventions


A total of 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. The patients were blinded to the solution used to clean their skin. Patients were followed up 1 and 4 weeks after surgery by a physician who was blinded to the skin preparation solution used at surgery. Evidence of infection according to Centers for Disease Control and Prevention criteria were documented.
Main Outcomes and Measures


The primary outcome of this study was port-site infection 30 days after surgery. Secondary outcomes were organ or space infections and any type of surgical site infections; the study also aimed to prospectively describe rates of surgical site infections in gynecological laparoscopies.
Results


Of the 661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis. The overall rate of port-site infection was 10.2% (65 of 640), rate of organ or space infection was 6.6% (42 of 640), and rate of any surgical site infection was 16.3% (104 of 640). The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
Conclusions and Relevance


Surgical site infections were more common than expected among patients who underwent gynecological laparoscopies. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.
Trial Registration


http://anzctr.org.au Identifier: ACTRN12617000475347.",2020,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","['patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions', 'February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center', '661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis', 'Patients', 'patients who underwent gynecological laparoscopies', 'patients undergoing gynecological laparoscopies', '221 patients were randomized to have their skin prepared preoperatively with', '661 patients 18 years or older who underwent an', 'for treatment of nonmalignant gynecological disorders']","['Surgical Skin Antisepsis', 'Gynecological Laparoscopic Surgery', 'water-based povidone-iodine', 'alcohol-based chlorhexidine', 'elective operative laparoscopy', 'povidone-iodine vs alcohol-based povidone-iodine', 'alcohol-based povidone-iodine', 'chlorhexidine vs alcohol-based povidone-iodine', 'chlorhexidine vs water-based povidone-iodine', 'skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine']","['surgical site infections in gynecological laparoscopies', 'overall rate of port-site infection', 'Surgical Site Infections', 'infection rates', 'rate of any surgical site infection', 'organ or space infections and any type of surgical site infections', 'rate of organ or space infection', 'odds ratio for port-site infection', 'rates of port-site infections, organ or space infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",221.0,0.146845,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","[{'ForeName': 'Uri P', 'Initials': 'UP', 'LastName': 'Dior', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Shamitha', 'Initials': 'S', 'LastName': 'Kathurusinghe', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Reddington', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': ""Department of Microbiology and Infectious Disease, The Royal Women's Hospital, Parkville, Australia.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Healey', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",JAMA surgery,['10.1001/jamasurg.2020.1953']
1213,32639099,Ex vivo-expanded autologous adipose tissue-derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial.,"Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor-blinded clinical trial comparing fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC-enriched fat grafts (≥20 × 10 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture-expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.clinicaltrials.gov, number H-16046960.",2020,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"['plastic surgery', 'breast augmentation']","['ASC-enriched fat grafts (≥20\u2009×\u200910 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts', 'Autologous fat grafting and implant surgery', 'fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs', 'Ex vivo-expanded autologous adipose tissue-derived stromal cells']","['retention rates', 'Volume retention']","[{'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]","[{'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0761152,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"[{'ForeName': 'Stig-Frederik T', 'Initials': 'ST', 'LastName': 'Kølle', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Duscher', 'Affiliation': 'Department of Plastic and Hand Surgery, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Taudorf', 'Affiliation': 'Department of Radiology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fischer-Nielsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Jesper D', 'Initials': 'JD', 'LastName': 'Svalgaard', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Munthe-Fog', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jønsson', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Selvig', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Frederik P', 'Initials': 'FP', 'LastName': 'Mamsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Katz', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",Stem cells translational medicine,['10.1002/sctm.20-0081']
1214,32634052,A randomized controlled trial to compare group motivational interviewing to very brief advice for the effectiveness of a workplace smoking cessation counseling intervention.,"BACKGROUND


Studies show that smokers have a lower work performance due to time spent smoking, increased fatigue perception and are more absent from work due to smoking-related diseases. The workplace could represent an important location to promote smoking cessation.
METHODS


This study is a multi-center, controlled trial for smoking cessation counseling at the participants' workplace, where 656 randomized participants received four sessions of group motivational interviewing or four sessions of very brief advice and were followed up for 52 weeks.
RESULTS


The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks 9 to 24 (13.4% vs. 3.4%) and weeks 9 to 52 (10.3% vs. 3.1%).
CONCLUSIONS


This study demonstrated that motivational interviewing is an efficacious smoking cessation approach for smokers at their workplace. The short-term and long-term cessation rate of the intervention of the smoking cessation counseling group exceeded that of very brief advice.",2020,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,['smokers at their workplace'],"['workplace smoking cessation counseling intervention', 'motivational interviewing', 'smoking cessation counseling']",['Continuous Quit Rate (CQR'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}]",656.0,0.0260156,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Floresta', 'Affiliation': 'Health and Safety Manager of Eurospin Sicily and Calabria, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Ledda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Vitale', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Venerando', 'Initials': 'V', 'LastName': 'Rapisarda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1782564']
1215,32651140,Dose preservation of ligament flavum really help prevent postoperative epidural fibrosis and improve outcome in microdiscectomy?,"OBJECTIVE


A prospective, randomized, controlled clinical study was conducted with surgery performed by the same surgeon. The aim was to present a new technique for preserving the ligament flavum during lumbar microdiscectomy, and to evaluate whether this helps prevent postoperative fibrosis and improve outcome.
METHODS


From January to December 2017, 251 patients with indication for microdiscectomy were randomly divided into test group using ligament flavum preservation technique and control group using conventional procedures. Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) were assessed before the surgery, and 3 days, 1 month, 6 months, 1 year and 2 years after the operation respectively. The grade of epidural fibrosis on MRI after 6 months was evaluated by two radiologists independently and double-blindly.
RESULTS


Both groups' VAS and ODI were significantly improved after surgery, but there was no significant difference between two groups at 3d and 1 month after operation. The grade of epidural fibrosis in test group was significantly lower than that in control group at 6 months postoperative. The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
CONCLUSION


Preservation of more ligament flavum is practicable during the procedure of microdiscectomy. It can prevent postoperative epidural fibrosis, and is helpful to achieve a better clinical outcome.",2020,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","['From January to December 2017, 251 patients with indication for microdiscectomy']",['ligament flavum preservation technique and control group using conventional procedures'],"['grade of epidural fibrosis', 'Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI', 'VAS and ODI', 'postoperative epidural fibrosis']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C1041712', 'cui_str': 'Brevibacterium flavum'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3203500', 'cui_str': 'Epidural fibrosis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",251.0,0.0163517,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","[{'ForeName': 'Jigang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Laboratory, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China. Electronic address: litaozhongguo@vip.163.com.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Shandong University Qilu Hospital. Jinan City, Shandong Province, 250000, China.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.013']
1216,32652092,A double-blind randomized trial comparing lidocaine spray and placebo spray anesthesia prior to cervical laminaria insertion.,"OBJECTIVE


To compare pain during laminaria insertion after lidocaine spray versus placebo spray anesthesia in women about to undergo a surgical abortion procedure.
STUDY DESIGN


A double blind, randomized, placebo-controlled trial of women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure. Participants received lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion. The primary outcome was participants' pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS). Secondary outcomes included scores at speculum removal and 15 min after speculum insertion.
RESULTS


From 7/2016 through 8/2018, we enrolled 68 and 66 women to the lidocaine and placebo groups, respectively. Baseline characteristics were similar in both groups. The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p = 0.69). Reported VAS after speculum removal and 15 min from speculum insertion were similar in the lidocaine and placebo groups (median 2.0, p = 0.99; median 1.0 vs. 1.5 respectively, p = 0.32). In multivariate analyses, lidocaine use was associated with decreased VAS score at 15 min from speculum insertion [95%CI -0.96 (-1.74 to -0.18), p = 0.016]. Reported VAS ≥7 at 1st laminaria insertion did not differ between lidocaine and placebo groups (5.88% vs. 10.61% respectively, p = 0.362).
CONCLUSION


In women scheduled for laminaria insertion prior to surgical uterine evacuation at 12-24 weeks gestation, topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo.
IMPLICATIONS


Our results imply that physicians should not use topical application of lidocaine spray to the cervix before laminaria insertion to reduce women's pain. Continued efforts must be made to find means to relieve pain by using simple, effective analgesia or adjusting the technique, and not using a tenaculum whenever possible.",2020,"The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p=0.69).","['women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure', 'women about to undergo a surgical abortion procedure']","['lidocaine spray versus placebo spray anesthesia', 'lidocaine and placebo', 'lidocaine', 'lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion', 'lidocaine spray and placebo spray anesthesia', 'lidocaine spray', 'placebo']","['scores at speculum removal and 15 minutes after speculum insertion', 'pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS', 'VAS score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0227837', 'cui_str': 'Endocervical structure'}, {'cui': 'C0227829', 'cui_str': 'Exocervical structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0022980', 'cui_str': 'Laminaria'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022980', 'cui_str': 'Laminaria'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",68.0,0.786929,"The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p=0.69).","[{'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Meyer', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Dr. Pinchas Bornstein Talpiot Medical Leadership Program, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel. Electronic address: raananmeir@gmail.com.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Cahan', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Yagel', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Afek', 'Affiliation': 'The Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Derazne', 'Affiliation': 'The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yochai', 'Initials': 'Y', 'LastName': 'Bar-Shavit', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yefet', 'Initials': 'Y', 'LastName': 'Yuval', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Shina', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Dr. Pinchas Bornstein Talpiot Medical Leadership Program, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel.'}]",Contraception,['10.1016/j.contraception.2020.07.002']
1217,32652112,"Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study.","BACKGROUND


In postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, the risk for distant recurrence can extend beyond 5 years of adjuvant endocrine therapy. This study aims to identify genomic driver alterations associated with late distant recurrence.
PATIENTS AND METHODS


Next generation sequencing was used to characterize driver alterations in primary tumors from a subset of 764 postmenopausal estrogen receptor-positive/HER2-negative patients from the BIG 1-98 randomized trial. Late distant recurrence events were defined as ≥5 years from time of randomization). The association of driver alterations with distant recurrence-free interval in early and late time periods was assessed using Cox regression models. Multivariable analyses were carried out to adjust for clinicopathological factors. Weighted analysis methods were used in order to correct for over-sampling of distant recurrences.
RESULTS


A total of 538 of 764 (70%) samples were successfully sequenced including 88 (63%) early and 52 (37%) late distant recurrence events after a median follow up of 8.1 years. In univariable analysis for late distant recurrence, PIK3CA mutations (58.8%) were significantly associated with reduced risk [hazard ratio (HR) 0.40, 95% confidence interval (CI) 0.20-0.82, P = 0.012], whereas amplifications on chromosome 8p11 (10.9%) (HR 4.79, 95% CI 2.30-9.97, P < 0.001) and BRCA2 mutations (2.3%) (HR 5.39, 95% CI 1.51-19.29, P = 0.010) were significantly associated with an increased risk. In multivariable analysis, only amplifications on 8p11 (P = 0.002) and BRCA2 mutations (P = 0.013) remained significant predictors.
CONCLUSIONS


In estrogen receptor-positive/HER2-negative postmenopausal early breast cancer, PIK3CA mutations were associated with reduced risk of late distant recurrence, whereas amplifications on 8p11 and BRCA2 mutations were associated with increased risk of late distant recurrence. The characterization of oncogenic driver alterations may aid in refining treatment choices in the late disease setting, and help identify potential drug targets for testing in future trials.",2020,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
",['primary tumors from a subset of 764 postmenopausal ER+/HER2- patients from the BIG 1-98 randomized trial'],[],"['Late distant recurrence events', 'late distant recurrence events', 'risk of late distant recurrence', 'BRCA2 mutations']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}]",,0.192938,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Luen', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Savas', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kammler', 'Affiliation': 'International Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'International Breast Cancer Study Group Central Pathology Office, Department of Pathology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Biasi', 'Affiliation': 'Division of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Demanse', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hackl', 'Affiliation': 'OncogenomX Inc., Allschwil, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thuerlimann', 'Affiliation': 'Breast Center, Cantonal Hospital, St Gallen, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Department of Pathology, University of Milan, Milan, Italy; IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': 'Sandro Pitigliani Department of Medical Oncology, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia. Electronic address: sherene.loi@petermac.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.024']
1218,32659755,Prophylactic Ligature of AV Fistula Prevents High Output Heart Failure after Kidney Transplantation.,"BACKGROUND


Arteriovenous (AV) fistulas are considered the gold standard for ensuring safe and long-term vascular access in patients with haemodialysis-dependent end-stage renal disease. However, previous studies demonstrated that high-flow AV fistulas might add additional cardiovascular burden in the post-transplant setting, leading to frequent fistula closure in this population. Currently, there is no consensus regarding management of high-flow fistulas in post-transplant patients with stable kidney function. The present randomized controlled trial examines the effect of prophylactic AV fistula closure on high-output heart failure.
METHODS


Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min were recruited and randomized in a 1:1 ratio to an intervention and control group, respectively. The intervention group was subject to immediate fistula ligature. Patients within the control group were referred to fistula ligature only if the main study endpoint high-output heart failure was reached. The latter was defined by the presence of at least 1 clinical sign (i.e., worsening NYHA score) and at least 2 of the following echocardiographic parameters: diameter of right atrium (major) >53 mm, right atrium (minor) >44 mm, inferior vena cava ≥21 mm, right pulmonary artery >20 mm, TAPSE <16 mm, systolic pulmonal artery pressure >40 mm Hg, and/or left ventricular eccentricity index <1. During a 24-month follow-up period, quarterly measurements of kidney function, NT-proBNP, and lactate dehydrogenase as well as a biannual echocardiographic check-up were performed.
RESULTS


High-output heart failure attributable to high-flow fistula was reported in 5 of 13 control patients (38.5%), whereas no patient in the intervention group presented with clinical and echocardiographic signs of high-output heart failure during the follow-up period. Thus, prophylactic ligature of high-flow fistulas avoided high-output heart failure in our patient population (p = 0.013). Three patients in the control group, however, had to undergo fistula ligature due to aneurysm formation (n = 2) and steal phenomenon (n = 1). Median NT-proBNP levels decreased from 317 ng/L pre-ligature to 223 ng/L post-ligature (p = 0.003). Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059). Improvement of echocardiographic findings (e.g., a decrease in systolic pulmonary arterial pressure) was found in 7 of 8 ligature patients but did not reach statistical significance.
CONCLUSION


Prophylactic ligature of high-flow AV fistulas after kidney transplantation can avoid high-output heart failure, and a more liberal approach to close AV fistulas might be justified.",2020,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","['patients with haemodialysis-dependent end-stage renal disease', 'Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min', 'Kidney Transplantation', 'post-transplant patients with stable kidney function']","['prophylactic AV fistula closure', 'Prophylactic Ligature of AV Fistula']","['clinical and echocardiographic signs of high-output heart failure', 'Serum creatinine levels', 'systolic pulmonary arterial pressure', 'systolic pulmonal artery pressure', 'Median NT-proBNP levels', 'kidney function, NT-proBNP, and lactate dehydrogenase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0023692', 'cui_str': 'Ligature'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0221045', 'cui_str': 'High output heart failure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",28.0,0.0372347,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hetz', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pirklbauer', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Department of Internal Medicine III - Cardiology and Angiology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Posch', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gummerer', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tiefenthaler', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria, martin.tiefenthaler@i-med.ac.at.'}]",American journal of nephrology,['10.1159/000508957']
1219,32621316,Pilot randomised controlled trial reporting should be focused.,,2020,,[],[],[],[],[],[],,0.223126,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Muggleton', 'Affiliation': 'Technical University of Munich, Germany.'}]",Anaesthesia,['10.1111/anae.15189']
1220,32621309,Pilot randomised controlled trial reporting should be focused: a reply.,,2020,,[],[],[],[],[],[],,0.205819,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Charlesworth', 'Affiliation': 'Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}]",Anaesthesia,['10.1111/anae.15199']
1221,32621900,Comparison of Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs in Terms of Visual Outcome: a Paired Contralateral Eye Study.,"PURPOSE


This study sought to compare the postoperative visual outcomes of toric implantable collamer lens (T-ICL) with toric Artiflex (T-Artiflex) lenses.
DESIGN


Alternating treatment, contralateral eye matched clinical study.
METHODS


This study compared 82 eyes of 41 patients with T-ICL lenses in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism. Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoperatively.
RESULTS


After a mean follow-up of 12 months, the safety index was mean 1.40 ± 0.70 in the T-ICL group and 1.20 ± 0.21 in the T-Artiflex group. Furthermore, their mean efficacy indexes were 1.24 ± 0.42 and 1.08 ± 0.23, respectively (P = .029). A total of 39 eyes (95%) in the T-ICL group and 41 eyes (100%) in the T-Artiflex group were within ±1.00 diopter (D) of emmetropia and 33 eyes (80%) and 34 eyes (83%) were within ±0.5 D of emmetropia, respectively. Vector analysis revealed mean index of success as large as 0.25 ± 0.22 in the T-ICL group and 0.24 ± 0.15 in the T-Artiflex group. Postoperative contrast sensitivities were equal in both groups under mesopic conditions for any given spatial frequency. There was an endothelial loss of 2.18% and 1.95% in the T-ICL and T-Artiflex groups, respectively. There were no significant complications in any of the groups.
CONCLUSIONS


Both lenses showed promising results in terms of safety, efficacy, and predictability for correction of myopic astigmatism. As shown in this paired-eye study, most outcomes were almost identical, and neither of these lenses were clinically superior to the other.",2020,"There was no significant complication in any of the groups.
",['82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism'],"['Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs', 'toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation']","['mean efficacy index', 'safety index', 'endothelial cell loss', 'Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events', 'mean index of success', 'safety, efficacy, and predictability']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.0443315,"There was no significant complication in any of the groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghoreishi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran; Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Kashfi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran. Electronic address: drkashfi@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Peyman', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadinia', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.021']
1222,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
1223,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1224,31582354,"Time-to-progression after front-line fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy for chronic lymphocytic leukaemia: a retrospective, multicohort study.","BACKGROUND


Fludarabine, cyclophosphamide, and rituximab (FCR) has become a gold-standard chemoimmunotherapy regimen for patients with chronic lymphocytic leukaemia. However, the question remains of how to treat treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia. We therefore aimed to develop and validate a gene expression signature to identify which of these patients are likely to achieve durable remissions with FCR chemoimmunotherapy.
METHODS


We did a retrospective cohort study in two cohorts of treatment-naive patients (aged ≥18 years) with chronic lymphocytic leukaemia. The discovery and training cohort consisted of peripheral blood samples collected from patients treated at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), who fulfilled the diagnostic criteria of the International Workshop on Chronic Lymphocytic Leukemia, had received at least three cycles of FCR chemoimmunotherapy, and had been treated between Oct 10, 2000, and Oct 26, 2006 (ie, the MDACC cohort). We did transcriptional profiling on samples obtained from the MDACC cohort to identify genes associated with time to progression. We did univariate Cox proportional hazards analyses and used significant genes to cluster IGHV-unmutated samples into two groups (intermediate prognosis and unfavourable prognosis). After using cross-validation to assess robustness, we applied the Lasso method to standardise the gene expression values to find a minimum gene signature. We validated this signature in an external cohort of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia enrolled on the CLL8 trial of the German Chronic Lymphocytic Leukaemia Study Group who were treated between July 21, 2003, and April 4, 2006 (ie, the CLL8 cohort).
FINDINGS


The MDACC cohort consisted of 101 patients and the CLL8 cohort consisted of 109 patients. Using the MDACC cohort, we identified and developed a 17-gene expression signature that distinguished IGHV-unmutated patients who were likely to achieve a long-term remission following front-line FCR chemoimmunotherapy from those who might benefit from alternative front-line regimens (hazard ratio 3·83, 95% CI 1·94-7·59; p<0·0001). We validated this gene signature in the CLL8 cohort; patients with an unfavourable prognosis versus those with an intermediate prognosis had a cause-specific hazard ratio of 1·90 (95% CI 1·18-3·06; p=0·008). Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
INTERPRETATION


We have developed a robust, reproducible 17-gene signature that identifies a subset of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia who might substantially benefit from treatment with FCR chemoimmunotherapy. We recommend testing the value of this gene signature in a prospective study that compares FCR treatment with newer alternative therapies as part of a randomised clinical trial.
FUNDING


Chronic Lymphocytic Leukaemia Global Research Foundation and the National Institutes of Health/National Cancer Institute.",2019,"Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
","['patients treated at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), who fulfilled the diagnostic criteria of the International Workshop on Chronic Lymphocytic Leukemia, had received at least three cycles of FCR chemoimmunotherapy, and had been treated between Oct 10, 2000, and Oct 26, 2006 (ie, the MDACC cohort', 'patients with chronic lymphocytic leukaemia', 'chronic lymphocytic leukaemia', 'two cohorts of treatment-naive patients (aged ≥18 years) with chronic lymphocytic leukaemia', 'naive patients with IGHV-unmutated chronic lymphocytic leukaemia', 'external cohort of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia enrolled on the CLL8 trial of the German Chronic Lymphocytic Leukaemia Study Group who were treated between July 21, 2003, and April 4, 2006 (ie, the CLL8 cohort', '101 patients and the CLL8 cohort consisted of 109 patients']","['Fludarabine, cyclophosphamide, and rituximab (FCR', 'fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy', 'FCR chemoimmunotherapy']",['Median time to progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",101.0,0.0518222,"Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Coombes', 'Affiliation': 'Department of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Lynn L', 'Initials': 'LL', 'LastName': 'Barron', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zachary B', 'Initials': 'ZB', 'LastName': 'Abrams', 'Affiliation': 'Department of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Majewski', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jolanta E', 'Initials': 'JE', 'LastName': 'Bondaruk', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Bogdan A', 'Initials': 'BA', 'LastName': 'Czerniak', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Oakes', 'Affiliation': 'Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Keating', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne V', 'Initials': 'LV', 'LastName': 'Abruzzo', 'Affiliation': 'Department of Pathology, The Ohio State University, Columbus, OH, USA. Electronic address: lynne.abruzzo@osumc.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30503-0']
1225,32638266,"Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry.","INTRODUCTION


Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany.
METHODS AND RESULTS


The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
CONCLUSIONS


In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.",2020,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","['5015 patients with non-valvular atrial fibrillation', 'patients with non-valvular atrial fibrillation', 'Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany', 'unselected patients with atrial fibrillation', 'unselected patients in Germany']","['Apixaban', 'warfarin', 'apixaban']","['NOACs or VKAs', 'non-fatal stroke', 'Inappropriate underdosing of apixaban', 'ISTH major bleeding', 'cause mortality', 'non-fatal myocardial infarction', 'moderate or minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",5015.0,0.0273181,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany. uwe.zeymer@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lober', 'Affiliation': 'Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Kardiologische Praxis, Stahnsdorf, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Praxis Dr. Richard, Erfurt, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Praxis Dr. Schäfer, Herfurth, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Taggeselle', 'Affiliation': 'Praxis Markkleeberg, Markkleeberg, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Kabitz', 'Affiliation': 'Klinikum Konstanz, Konstanz, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Prondzinsky', 'Affiliation': 'Carl-Von-Basedow-Klinikum Merseburg, Merseburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Süselbeck', 'Affiliation': 'Kardiologische Praxisklinik Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-020-00188-1']
1226,32638409,Dietary macronutrient regulation of acyl and desacyl ghrelin concentrations in children with Prader-Willi syndrome (PWS).,"BACKGROUND


The effects of dietary macronutrients on orexigenic and anorexigenic hormones in children are poorly understood.
OBJECTIVE


To explore effects of varying dietary macronutrients on appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide 1 (GLP-1), peptide tyrosine tyrosine (PYY) and insulin] in children with PWS and healthy children (HC).
DESIGN


Randomized, cross-over experiments compared two test diets [high protein-low carbohydrate (HP-LC) and high protein-low fat (HP-LF)] to a STANDARD meal (55% carbohydrate, 30% fat, 15% protein). Experiment 1 included ten children with PWS (median age 6.63 years; BMI z 1.05); experiment 2 had seven HC (median age 12.54 years; BMI z 0.95). Blood samples were collected at baseline and at 60-minute intervals for 4 hours. Independent linear mixed models were adjusted for age, sex and BMI z-score.
RESULTS


Fasting and post-prandial AG and DAG concentrations are elevated in PWS children; the ratio of AG/DAG is normal. Food consumption reduced AG and DAG concentrations in both PWS and HC. GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (P = .02-0.04). The fasting proinsulin to insulin ratio (0.08 vs 0.05) was higher in children with PWS (P = .05) than in HC. Average appetite scores in HC declined after all three meals (P = .02) but were lower after the HP-LC and HP-LF meals than the STANDARD meal.
CONCLUSION


Altered processing of proinsulin and increased GLP-1 secretion in children with PWS after a high protein meal intake might enhance satiety and reduce energy intake.",2020,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"['children with PWS', 'children with Prader-Willi syndrome (PWS', 'children with PWS and healthy children (HC', 'Experiment 1 included ten children with PWS (median age 6.63y; BMI z 1.05); experiment 2 had seven HC (median age 12.54y; BMI z 0.95']","['varying dietary macronutrients', 'diets [High Protein-Low Carbohydrate (HP-LC) and High Protein-Low Fat (HP-LF', 'dietary macronutrients']","['Fasting and post-prandial AG and DAG concentrations', 'Blood samples', 'GLP-1 levels', 'GLP-1 secretion', 'fasting proinsulin to insulin ratio', 'Average appetite scores in HC', 'AG and DAG concentrations', 'satiety and reduce energy intake', 'appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide\xa01 (GLP-1), peptide tyrosine tyrosine (PYY), and insulin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0011967', 'cui_str': '1,2,5,6-Dianhydrogalactitol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0965048', 'cui_str': 'ghrelin, des-n-octanoyl'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}]",10.0,0.035134,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alsaif', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Pakseresht', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Gaylinn', 'Affiliation': 'Division of Endocrinology, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Thorner', 'Affiliation': 'Division of Endocrinology, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Field', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}]",Clinical endocrinology,['10.1111/cen.14279']
1227,32646498,"Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study.","BACKGROUND


This study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT).
METHODS


This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n = 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n = 171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period.
RESULTS


In a mixed-effects model for repeated measures, the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), significantly declined in both the tofogliflozin (- 0.132 mm, SE 0.007; - 0.163 mm, SE 0.013; - 0.170 mm, SE 0.020, respectively) and the control group (- 0.140 mm, SE 0.006; - 0.190 mm, SE 0.012; - 0.190 mm, SE 0.020, respectively). Furthermore, the tofogliflozin and the conventional treatment group did not significantly differ in the progression of the mean-IMT-CCA (mean change (95% CI) 0.008 (- 0.009, 0.025) mm, P = 0.34), along with the right (mean change (95% CI) 0.027 (- 0.005, 0.059) mm, P = 0.10) and the left max-IMT-CCA (mean change (95% CI) 0.020 (- 0.030, 0.070), P = 0.43). Similar findings were obtained even after adjusting for traditional CV risk factors and/or administration of drugs at baseline. Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C. The total and serious adverse events incidences did not significantly vary between the treatment groups.
CONCLUSIONS/INTERPRETATION


No IMT changes were observed between the tofogliflozin and the conventional treatment groups. However, tofogliflozin is a safe and effective treatment option for managing primary CVD risk factors in this population. Clinical Trial Registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).",2020,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","['340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units', 'type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT', 'patients with type 2 diabetes']","['tofogliflozin', 'Tofogliflozin', 'tofogliflozin treatment group (n\u2009=\u2009169) or conventional treatment group using drugs other than SGLT2 inhibitors', 'tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor']","['carotid atherosclerosis', 'changes in mean and maximum common carotid IMT', 'HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C', 'progression of the mean-IMT-CCA', 'mean IMT of the common carotid artery', 'left max-IMT-CCA', 'IMT changes', 'total and serious adverse events incidences']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",340.0,0.0458559,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Mita', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yoshii', 'Affiliation': 'Department of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara City, Osaka, 582-0005, Japan.'}, {'ForeName': 'Tetsuyuki', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Umayahara', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.'}, {'ForeName': 'Tsunehiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki City, Hyogo, Japan.'}, {'ForeName': 'Nobuichi', 'Initials': 'N', 'LastName': 'Kuribayashi', 'Affiliation': 'Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi City, Chiba, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Kitasenri Maeda Clinic, 4-119 Furuedai, Suita, Osaka, 565-0874, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kosugi', 'Affiliation': 'Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ohtoshi', 'Affiliation': 'Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Clinic, 3-9-23 Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sumitani', 'Affiliation': 'Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Tsugawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Ryomoto', 'Affiliation': 'Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taki', 'Affiliation': 'Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01079-4']
1228,32656869,Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.,"BACKGROUND


Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.
AIM


To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.
METHODS


A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.
RESULTS


Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.
CONCLUSION


This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.",2020,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","['patients with PPI-refractory heartburn', 'PPI non-responding patients with heartburn', 'patients with gastro-oesophageal reflux disease responding to PPIs']","['oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn', 'oesophageal radiofrequency', 'proton pump inhibitors (PPIs']","['moderate-to-severe heartburn', 'occurrence of adverse events', 'number of days without heartburn, days with PPI consumption', 'clinical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",62.0,0.307362,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Sacher-Huvelin', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Melchior', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology Department, CHU de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Chabrun', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Vavasseur', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gorbatchef', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zalar', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mion', 'Affiliation': 'Digestive Physiology Department, Hospices Civils de Lyon, Université de Lyon, Inserm U1082 LabTau, Lyon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Robaszkiewicz', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Le Rhun', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Methodology and Biostatistics Department, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paul Galmiche', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Bruley des Varannes', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15936']
1229,32628922,"Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy.","PURPOSE


To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN


Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
METHODS


Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS


Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P < .001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P = .001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%).
CONCLUSIONS


The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina, Philadelphia, Pennsylvania, USA; The Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
1230,32638504,"Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Randomized, Double-blind, Active-comparator, Multi-center, Multi-country Trial.","OBJECTIVE


The SELECT-EARLY trial studied the effect of upadacitinib, an oral, reversible, JAK inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to methotrexate.
METHODS


Patients were randomized (n=947, 1:1:1) to once-daily upadacitinib (15mg or 30mg) or weekly methotrexate (7.5-20mg/week) for 24 weeks. The primary endpoints were: proportions of patients achieving ≥50% response in the American College of Rheumatology (ACR) criteria at Week 12, and proportions achieving a 28-joint Disease Activity Score including C-reactive protein (DAS28[CRP]) of <2.6 at Week 24. Data are presented through Week 24.
RESULTS


At baseline, median disease duration was 0.5 years (range 0-44 years). 840 (89%) patients completed 24 weeks of treatment. The study met both primary endpoints for upadacitinib 15mg and 30mg versus methotrexate (ACR50 at Week 12: 52% and 56% versus 28%, P<0.001; DAS28(CRP) <2.6 at Week 24: 48% and 50% versus 19%, P<0.001). Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate. Overall, 88% and 89% of upadacitinib 15mg and 30mg patients had no radiographic progression (mTSS ≤0; methotrexate: 78%; at least P<0.01). Through Week 24, the frequency of treatment-emergent adverse events was similar between the methotrexate (65%) and upadacitinib 15mg arms (64%), but slightly higher in the upadacitinib 30mg arm (71%). Six deaths were reported (upadacitinib 15mg: 2, upadacitinib 30mg: 3, methotrexate: 1).
CONCLUSION


Both doses of upadacitinib monotherapy demonstrated significant improvements in clinical, radiographic, and patient-reported outcomes versus methotrexate.",2020,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"['Patients were randomized (n=947, 1:1:1) to', 'naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY', 'patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to methotrexate']","['upadacitinib 15mg and 30mg versus methotrexate ', 'Methotrexate', 'upadacitinib monotherapy', 'Upadacitinib Monotherapy', 'methotrexate', 'once-daily upadacitinib', 'upadacitinib, an oral, reversible, JAK inhibitor']","['Efficacy and Safety', 'median disease duration', 'frequency of treatment-emergent adverse events', 'proportions of patients achieving ≥50% response in the American College of Rheumatology (ACR) criteria at Week 12, and proportions achieving a 28-joint Disease Activity Score including C-reactive protein (DAS28[CRP', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.286938,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': 'The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital Universitario Marques de Valdecilla, Santander, IDIVAL, Cantabria, Spain.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41384']
1231,32640411,"The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.","BACKGROUND


Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change.
METHODS


A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA).
RESULTS


Analysis yielded three overarching themes: taking part in a treatment trial - ""the only thing out there"", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an ""unpredictable recovery"".
CONCLUSIONS


People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.",2020,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","['participants with dissociative seizures', 'adults with Dissociative non-Epileptic Seizures (CODES) Trial', '30 participants in an', 'people with dissociative seizures (DS']","['DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC', 'RCT (the COgnitive behavioral therapy vs standardized medical care']",[],"[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",[],30.0,0.0596229,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purnell', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107230']
1232,32646282,"Effects of judo training upon body composition, autonomic function, and cardiorespiratory fitness in overweight or obese children aged 8- to 13 years.","Physical training is recommended for obese paediatric populations. We investigated the effects of recreational judo training (JT) upon body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV) in overweight or obese children. A controlled trial (RBR-9d94td) was conducted with 35 children (8-13 years) assigned into groups according to their body mass index (BMI): eutrophic (EU; n = 15; z-BMI ≤ +l and ≥ -2) and overweight or obese (OB; n = 20; z-BMI > +1 and ≤ +3). The 12-week JT included 60-min sessions performed 2 times/week at 65-75% maximal heart rate (HR). BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning were assessed. Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%). Increases (P < 0.05) occurred in lean mass (~8%), parasympathetic modulation (log HF, ~4%), VO 2peak  (~5-10%), and VO 2  (~15%), speed (~10%) and slope (~13%) at GET. Markers of cardiorespiratory fitness (relative VO 2 , slope and speed at GET) in OB approached EU after JT. In conclusion, a relatively short JT intervention to improved body composition, autonomic modulation, and physical fitness in obese children.",2020,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","['obese children', '35 children (8-13\xa0years) assigned into groups according to their', '2) and overweight or obese (OB; n =\xa020; z-BMI > +1 and ≤ +3', 'overweight or obese children aged 8- to 13 years', 'obese paediatric populations', 'overweight or obese children']","['recreational judo training (JT', 'Physical training', 'judo training', 'JT intervention', 'body mass index (BMI): eutrophic (EU; n =\xa015; z-BMI ≤ +l and ≥']","['body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV', 'BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning', 'lean mass', 'body composition, autonomic function, and cardiorespiratory fitness', 'cardiorespiratory fitness (relative VO 2 , slope and speed at GET', 'sympathovagal balance', 'OB', 'parasympathetic modulation', 'body composition, autonomic modulation, and physical fitness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",35.0,0.0188821,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","[{'ForeName': 'Iedda', 'Initials': 'I', 'LastName': 'Brasil', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Walace', 'Initials': 'W', 'LastName': 'Monteiro', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Tainah', 'Initials': 'T', 'LastName': 'Lima', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto , Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}]",Journal of sports sciences,['10.1080/02640414.2020.1792189']
1233,31381878,Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.,"OBJECTIVE


To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy.
STUDY DESIGN


We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation.
RESULTS


Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of the 207 WC efficacy uses with evaluable postcoital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses.
CONCLUSIONS


When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies.
IMPLICATIONS


Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.",2019,"Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03).",['Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC'],[],['rate of semen exposure'],"[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C4517769', 'cui_str': '408'}]",[],"[{'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0769976,"Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03).","[{'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010. Electronic address: twalsh@essentialaccess.org.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Snead', 'Affiliation': 'Division of Reproductive Health, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333.'}, {'ForeName': 'Breione J', 'Initials': 'BJ', 'LastName': 'St Claire', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'CONRAD/EVMS, 1911 N. Fort Myer Drive, Ste. 900, Arlington, VA 22209.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Mauck', 'Affiliation': 'CONRAD/EVMS, 1911 N. Fort Myer Drive, Ste. 900, Arlington, VA 22209.'}, {'ForeName': 'Ron G', 'Initials': 'RG', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Obstetrics & Gynecology, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'University of Pennsylvania Medical Center, 3701 Market St., Ste. 800, Philadelphia, PA 19104.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Nelson', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St., Cincinnati, OH 45219.'}, {'ForeName': 'Livia S', 'Initials': 'LS', 'LastName': 'Wan', 'Affiliation': 'Department of Obstetrics & Gynecology, New York University,462 First Ave., New York, NY 10016.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC 27244.'}]",Contraception,['10.1016/j.contraception.2019.07.143']
1234,32650511,"Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","OBJECTIVE


the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ) on the symptoms and functionality of knee osteoarthritis (OA).
METHODS


60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs - NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured.
RESULTS


In FS-HA ®  treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values ( p  < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05). The FS-HA ®  treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones ( p  < 0.05).
CONCLUSION


the oral supplementation with a FS-HA ®  characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.",2020,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","['60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA', 'Knee Osteoarthritis']","['oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ', 'New Oral Sodium Hyaluronate Formulation', 'Placebo', 'placebo']","['Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p', 'VAS-p, pain and total WOMAC score, LFI and ROM', 'range of knee joint motion (ROM', 'pain WOMAC score']","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",60.0,0.177501,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Girolimetto', 'Affiliation': 'Department of Rheumatology, Azienda USL-IRCCS di Reggio Emilia, 42121 Reggio Emilia, Italy.'}, {'ForeName': 'Crescenzio', 'Initials': 'C', 'LastName': 'Bentivenga', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Grandi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fogacci', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}]","Diseases (Basel, Switzerland)",['10.3390/diseases8030026']
1235,32664486,"A Phase 2a Randomized, Double-Blind, Dose-Optimizing Study to Evaluate the Immunogenicity and Safety of a Bivalent DNA Vaccine for Hemorrhagic Fever with Renal Syndrome Delivered by Intramuscular Electroporation.","Hantaan virus (HTNV) and Puumala virus (PUUV) are pathogenic hantaviruses found in Asia and Europe, respectively. DNA vaccines targeting the envelope glycoproteins of these viruses have been constructed and found to elicit neutralizing antibodies when delivered to humans by various technologies including intramuscular electroporation. Here, we report findings from a Phase 2a clinical trial of a combined HTNV/PUUV DNA vaccine delivered at varying doses and administration schedules using the Ichor Medical Systems TriGrid intramuscular electroporation delivery technology. The study was designed to characterize the effects of DNA vaccine dose and number of administrations on the frequency and magnitude of immunological response. Subjects ( n  = 120) were divided into four cohorts. Cohorts 1 and 2 received a dose of 2 mg of DNA (1 mg per plasmid), and cohorts 3 and 4 received a dose of 1 mg of DNA (0.5 mg per plasmid) each vaccination. Each of the four cohorts received a series of four administrations (days 0, 28, 56 and 168). For cohorts 1 and 3, the DNA vaccine candidate was delivered at each of the four administrations. For cohorts 2 and 4, in order to maintain blinding, subjects received the DNA vaccine on days 0, 56 and 168, but on day 28 received only the phosphate buffered saline vehicle rather the DNA vaccine. Sera were collected on days 0, 28, 56, 84, 140, 168, 196, 252 and 365 and evaluated for the presence of neutralizing antibodies by PUUV and HTNV pseudovirion neutralization assays (PsVNAs). Day 84 was also evaluated by a plaque reduction neutralization test (PRNT). Overall the PsVNA50 geometric mean titers (GMTs) and seropositivity rates among cohorts were similar. Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.",2020,"Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.","['Hemorrhagic Fever with Renal Syndrome Delivered by Intramuscular Electroporation', 'Subjects ( n  = 120']","['combined HTNV/PUUV DNA vaccine', 'DNA', 'phosphate buffered saline vehicle rather the DNA vaccine', 'Bivalent DNA Vaccine', 'DNA vaccine']","['Immunogenicity and Safety', 'PsVNA50 geometric mean titers (GMTs) and seropositivity rates', 'plaque reduction neutralization test (PRNT']","[{'cui': 'C0019101', 'cui_str': 'Hemorrhagic fever with renal syndrome'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0205790', 'cui_str': 'Puumala virus'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}]",120.0,0.102299,"Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Paolino', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kwilas', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Josleyn', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Somerville', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wisniewski', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hill', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanchez-Lockhart', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems, Inc., San Diego, CA 92121, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Schmaljohn', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}]",Vaccines,['10.3390/vaccines8030377']
1236,32672829,Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.,"Importance


Diabetic foot ulcers are a common complication of diabetes and require specialized treatment. Cold atmospheric plasma (CAP) has been associated with benefits in wound infection and healing in previous smaller series of case reports. Yet the effect of CAP compared with standard care therapy in wound healing in diabetic foot ulcers remains to be studied.
Objective


To determine whether the application of CAP accelerates wound healing in diabetic foot ulcers compared with standard care therapy.
Design, Setting, and Participants


A prospective, randomized, placebo-controlled, patient-blinded clinical trial was conducted at 2 clinics with recruitment from August 17, 2016, to April 20, 2019. Patients were scheduled to remain in follow-up until April 30, 2024. Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible. A patient could participate with 1 or more wounds in both groups in both intervention and control groups. Wounds were randomized separately, allowing a participant to be treated several times within the study following a 2 × 2 × 2 randomization strata considering sex, smoking status, and age (≤68 years and >68 years).
Interventions


Standard care treatment with 8 applications of either CAP generated from argon gas in an atmospheric pressure plasma jet or 8 applications of placebo treatment in a patient-blinded manner.
Main Outcomes and Measures


Primary end points were reduction in wound size, clinical infection, and microbial load compared with treatment start. Secondary end points were time to relevant wound reduction (>10%), reduction of infection, parameters of patient's well-being, and treatment-associated adverse events.
Results


Of 65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients were randomized to CAP and 32 wounds from 28 to placebo, with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample). Four patients with 5 wounds of 31 (16.1%) wounds in the CAP group and 3 patients with 4 wounds of 31 (13%) wounds in the placebo group were active smokers. CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009). Reduction of infection and microbial load was not significantly different between CAP and placebo. No therapy-related adverse events occurred during therapy; patient's perceptions during therapy were comparable.
Conclusions and Relevance


In this randomized clinical trial, CAP therapy resulted in beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection.
Trial Registration


ClinicalTrials.gov Identifier: NCT04205942.",2020,"CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009).","['Patients were scheduled to remain in follow-up until April 30, 2024', ' with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample', 'Patients With Diabetic Foot Ulcers', '2 clinics with recruitment from August 17, 2016, to April 20, 2019', 'diabetic foot ulcers', '65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients', 'Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible']","['CAP therapy', 'Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo', 'Cold atmospheric plasma (CAP', 'standard care therapy', 'CAP', 'placebo']","[""reduction of infection, parameters of patient's well-being, and treatment-associated adverse events"", 'time to relevant wound reduction', 'Wound Healing', 'total mean (SD) area reduction', 'wound healing', 'adverse events', 'reduction in wound size, clinical infection, and microbial load', 'Reduction of infection and microbial load']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",4.0,0.164355,"CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009).","[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Stratmann', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Tania-Cristina', 'Initials': 'TC', 'LastName': 'Costea', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Nolte', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hiller', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Reindel', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Masur', 'Affiliation': 'Leibniz-Institut für Plasmaforschung und Technologie, Greifswald, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Motz', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Center for Clinical Studies Bremen, Bremen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kerner', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Diethelm', 'Initials': 'D', 'LastName': 'Tschoepe', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.10411']
1237,32687804,"Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study.","BACKGROUND


Long-term protection and herd immunity induced by existing pertussis vaccines are imperfect, and a need therefore exists to develop new pertussis vaccines. This study aimed to investigate the safety, colonisation, and immunogenicity of the new, live attenuated pertussis vaccine, BPZE1, when given intranasally.
METHODS


This phase 1b, double-blind, randomised, placebo-controlled, dose-escalation study was done at the phase 1 unit, Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden. Healthy adults (18-32 years) were screened and included sequentially into three groups of increasing BPZE1 dose strength (10 7  colony-forming units [CFU], 10 8  CFU, and 10 9  CFU), and were randomly assigned (3:1 within each group) to receive vaccine or placebo. Vaccine and placebo were administered in phosphate-buffered saline contained 5% saccharose as 0·4 mL in each nostril. The primary outcome was solicited and unsolicited adverse events between day 0 and day 28. The analysis included all randomised participants who received a vaccine dose. Colonisation with BPZE1 was determined by repeatedly culturing nasopharyngeal aspirates at day 4, day 7, day 11, day 14, day 21, and day 28 after vaccination. Immunogenicity, as serum IgG and IgA responses were assessed at day 0, day 7, day 14, day 21, day 28, 6 months, and 12 months after vaccination. This trial is registered at Clinicaltrials.gov, NCT02453048.
FINDINGS


Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive vaccine or placebo, with 12 participants each in a low-dose, medium-dose, and high-dose vaccine group. Adverse events between day 0 and day 28 were reported by one (8%, 95% CI 0-39) of 12 participants in both the placebo and low-dose groups, and two (17%; 2-48) of 12 participants in both the medium-dose and high-dose groups, including cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion. During this time, none of the participants experienced any spasmodic cough, difficulties in breathing, or adverse events following immunisation concerning vital signs. The tested doses of BPZE1 or placebo were well tolerated, with no apparent difference in solicited or unsolicited adverse events following immunisation between groups. Colonisation at least once after vaccination was observed in 29 (81%; 68-93) of 36 vaccinated participants. The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
INTERPRETATION


The tested vaccine was safe, induced a high colonisation rate in an adult population, and was immunogenic at all doses. These findings justify further clinical development of BPZE1 to ultimately be used as a priming vaccine for neonates or a booster vaccine for adolescents and adults, or both.
FUNDING


ILiAD Biotechnologies.",2020,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","['Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive', 'Healthy adults (18-32 years']","['vaccine or placebo', 'BPZE1 or placebo', 'Vaccine and placebo', 'live attenuated intranasal pertussis vaccine BPZE1', 'phosphate-buffered saline contained 5% saccharose as 0·4', 'placebo']","['spasmodic cough, difficulties in breathing, or adverse events', 'Safety and immunogenicity', 'Adverse events', 'Immunogenicity, as serum IgG and IgA responses', 'solicited and unsolicited adverse events', 'safety, colonisation, and immunogenicity', 'cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion', 'serum IgG and IgA titres', 'solicited or unsolicited adverse events', 'Colonisation']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0277870', 'cui_str': 'Spasmodic cough'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",120.0,0.664209,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Jahnmatz', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Al-Tawil', 'Affiliation': 'Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Storsaeter', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Colin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bauduin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Thalen', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Solovay', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rubin', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mielcarek', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France.'}, {'ForeName': 'Rigmor', 'Initials': 'R', 'LastName': 'Thorstensson', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Locht', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France. Electronic address: camille.locht@pasteur-lille.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30274-7']
1238,32675432,Combining neurofeedback with source estimation: Evaluation of an sLORETA neurofeedback protocol for chronic tinnitus treatment.,"BACKGROUND


Alpha/delta neurofeedback has been shown to be a potential treatment option for chronic subjective tinnitus. Traditional neurofeedback approaches working with a handful of surface electrodes have been criticized, however, due to their low spatial specificity.
OBJECTIVE


The purpose of this study was to evaluate an innovative tomographic neurofeedback protocol that combines neural activity measured across the whole scalp with sLORETA source estimation.
METHODS


Forty-eight tinnitus patients participated in 15 neurofeedback training sessions as well as extensive pre, post, and follow-up testing. Patients were randomly assigned to either a tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF) group. Main outcome measures of this study were defined as tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands.
RESULTS


For both groups a significant reduction of tinnitus-related distress and tinnitus loudness was found. While distress changes remained persistent irrespective of group, loudness levels returned to baseline in the follow-up period. No significant between-group differences between the 2 neurofeedback applications (TONF vs. NTNF) were found, which suggests a similar contribution to symptom improvement. The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period. This effect was found irrespective of group on both surface and source levels with no meaningful differences between the 2 groups.
CONCLUSIONS


Our study shows that a tomographic alpha/delta protocol should be considered a promising addition to tinnitus treatment but that more individually specific neurofeedback protocols should be developed.",2020,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"['chronic tinnitus treatment', 'Forty-eight tinnitus patients participated in 15']","['neurofeedback training sessions', 'tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF']","['tinnitus-related distress and tinnitus loudness', 'trained alpha/delta ratio', 'tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands', 'loudness levels']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",48.0,0.0426258,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Güntensperger', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kleinjung', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neff', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thüring', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}]",Restorative neurology and neuroscience,['10.3233/RNN-200992']
1239,32631401,The impacts of multiple obesity-related interventions on quality of life in children and adolescents: a randomized controlled trial.,"BACKGROUND AND PURPOSE


Obesity has become a serious public health problem and family- and school-based interventions including physical exercise and diet control have been widely applied to attempt to combat this issue. The purpose of our study was to verify the effectiveness of an obesity-related comprehensive intervention model aimed at improving quality of life (QoL) among adolescents.
METHODS


A cluster randomized controlled trial (RCT) was conducted involving 948 subjects who were divided into an intervention group (n = 518) and a control group (n = 430). The intervention group received 1 year of obesity-related health education, physical exercise, and diet control. Their baseline body mass index (BMI) was calculated, and their QoL and basic information were assessed both before and after the intervention period using a self-designed Adolescent Quality of Life Scale and a basic information questionnaire.
RESULTS


After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group. Improved psychological QoL in the intervention group was our most robust study finding, with increases in psychological (B = 1.883, SE = 0.646, P = 0.004), pubertal (B = 0.853, SE = 0.296, P = 0.004) and total (B = 3.024, SE = 1.214, P = 0.013) QoL all being higher in this group. This intervention effect was found to be more substantial in boys than in girls.
CONCLUSIONS


Family-individual-school-based interventions combining obesity-related health education, physical exercise, and diet control can improve psychological, pubertal, and total QoL in children, with these effects being most pronounced in boys.
TRIAL REGISTRATION


retrospectively registered NCT02343588 .",2020,"After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group.","['adolescents', '948 subjects who were divided into an intervention group (n\u2009=\u2009518) and a control group (n\u2009=\u2009430', 'children and adolescents']","['multiple obesity-related interventions', '1 year of obesity-related health education, physical exercise, and diet control']","['quality of life', 'psychological QoL', 'quality of life (QoL', 'baseline body mass index (BMI', 'psychological', 'psychological, social, and pubertal dimensions, and in total QoL']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",948.0,0.0333573,"After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Diao', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China. wangh111111@aliyun.com.'}, {'ForeName': 'Lianjian', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01459-0']
1240,32643311,A network physiology approach to oxygen saturation variability during normobaric hypoxia.,"NEW FINDINGS


What is the central question of this study? What is the physiological interpretation of  S   p   O   2        fluctuations observed during normobaric hypoxia in healthy individuals? What is the main finding and its importance? There is a significant flow of information between  S   p   O   2        and other cardio-respiratory time series during graded hypoxia. Analysis of the pattern of  S   p   O   2        variations has potential for non-invasive assessment of the engagement of respiratory control system in health and disease.
ABSTRACT


Peripheral capillary oxygen saturation (  S   p   O   2        ) exhibits a complex pattern of fluctuations during hypoxia. The physiological interpretation of  S   p   O   2        variability is not well understood. In this study, we tested the hypothesis that  S   p   O   2        fluctuation carries information about integrated cardio-respiratory control in healthy individuals using a network physiology approach. We explored the use of transfer entropy in order to compute the flow of information between cardio-respiratory signals during hypoxia. Twelve healthy males (mean (SD) age 22 (4) years) were exposed to four simulated environments (fraction of inspired oxygen (  F   I   O   2        ): 0.12, 0.145, 0.17, and 0.2093) for 45 min, in a single blind randomized controlled design. The flow of information between different physiological parameters (  S   p   O   2        , respiratory frequency, tidal volume, minute ventilation, heart rate, end-tidal pressure of O 2  and CO 2  ) were analysed using transfer entropy. Normobaric hypoxia was associated with a significant increase in entropy of the  S   p   O   2        time series. The transfer entropy analysis showed that, particularly at  F   I   O   2        0.145 and 0.12, the flow of information between  S   p   O   2        and other physiological variables exhibits a bidirectional relationship. While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia,  S   p   O   2        remained the main hub of this network.  S   p   O   2        fluctuations during graded hypoxia exposure carry information about cardio-respiratory control. Therefore,  S   p   O   2        entropy analysis has the potential for non-invasive assessment of the functional connectivity of respiratory control system in various healthcare settings.",2020,"While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia, SpO 2  remained the main hub of this network.","['Twelve healthy males (age [SD] 22 [4] years', 'healthy individuals']",[],"['flow of information between different physiological parameters (SpO 2  , respiratory frequency, tidal volume, minute ventilation, heart rate, end-tidal pressure of O 2  and CO 2  ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",12.0,0.0544062,"While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia, SpO 2  remained the main hub of this network.","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Williams', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Nawamin', 'Initials': 'N', 'LastName': 'Panyapiean', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Amar S', 'Initials': 'AS', 'LastName': 'Bhogal', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Tipton', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Corbett', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Mani', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, UK.'}]",Experimental physiology,['10.1113/EP088755']
1241,32651711,Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,"PURPOSE


This study aimed to examine the complications by comparing two surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA) to one surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA).
METHODS


Two hundred forty-six participants were prospectively randomized into two groups: two-surgeon bilateral TKA and single-surgeon bilateral TKA. While two surgeons performed simultaneous total knee arthroplasty in the two-surgeon bilateral TKA group, one surgeon performed sequentially in the single-surgeon bilateral TKA group. Ninety-day major, and minor complications rate, operative time, estimated blood loss (EBL) and patient-reported outcome measures were analysed.
RESULTS


The two surgeons operated in two-surgeon bilateral TKA group 246 knees in 123 patients, while the single surgeon operated in single-surgeon bilateral TKA group 246 knees of 123 patients. The median operating time was 120 (range 70-151) minutes in the two-surgeon bilateral TKA group and 140 (range 75-190) minutes in the single-surgeon bilateral TKA group (p < 0.001). The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001). The 90-day complications were two major complications (1.6%) in the two-surgeon bilateral TKA group and 11 (8.9%) in the single-surgeon bilateral TKA group (p = 0.01).
CONCLUSION


Two-surgeon simultaneous bilateral TKA is a safe method with lower complication rates compared with single-surgeon sequential bilateral TKA and can be preferred for experienced teams. However, peri- and post-operative care is required to decrease the risk of bleeding, particularly in patients undergoing two-surgeon simultaneous bilateral TKA.
TRIAL REGISTRATION


This study was retrospectively registered in a public trials registry ( https://clinicaltrials.gov/ , NCT04299516).",2020,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"['group 246 knees of 123 patients', 'Two hundred forty-six participants']","['two-surgeon bilateral TKA and single-surgeon bilateral TKA', 'single surgeon operated in single-surgeon bilateral TKA', 'surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA', 'one-stage bilateral total knee arthroplasty\xa0-one surgeon sequential vs. two surgeons simultaneous', 'surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA']","['complication rates', '90-day complications', 'minor complications rate, operative time, estimated blood loss (EBL', 'median EBL', 'risk of bleeding', 'median operating time', 'simultaneous total knee arthroplasty']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",246.0,0.188458,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04704-9']
1242,32652548,Comment on: The LAPOP trial of laparoscopic or open distal pancreatectomy.,,2020,,[],['laparoscopic or open distal pancreatectomy'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]",[],,0.0272785,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}]",The British journal of surgery,['10.1002/bjs.11776']
1243,32666240,Locking compression plate fixation versus intramedullary nailing of humeral shaft fractures: which one is better? A single-centre prospective randomized study.,"PURPOSE


To compare the radiological and clinical outcomes of interlocking nail (ILN) and locking plate fixation (LCP) for humeral shaft fractures.
METHODS


A total of 63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively. They were divided randomly into two as LCP fixation (group 1) and interlocking nail (ILN) (group 2). Functional outcomes were evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS).
RESULTS


After fracture callus was radiologically observed, DASH, ASES, and UCLA scores as well as SF-36 questionnaires and VAS results were noted to have no significant difference between the two groups (p = 0.109, p = 0.082, p = 0.146, p = 0.322, and p = 0.175, respectively). At the last follow-up (post-operative 24 months), the UCLA score was significantly better in group 1 (p = 0.034), whereas VAS result was significantly worse in group 2 (p = 0.017). DASH, ASES scores, and SF-36 questionnaires had no difference (p = 0.193, p = 0.088, p = 0.289). Other parameters revealed no significant differences. Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189). Four patients in group 1 and five patients in group 2 underwent surgery for nonunion (p = 0.725). Post-operative radial nerve palsy was seen in one patient in group 2. Two patients in group 1 with superficial infection were treated with antibiotics, and they recovered.
CONCLUSIONS


Regarding our results, the LCP group had significantly better shoulder function than the ILN group, whereas the ILN group had significantly less pain, with similar complication rates. Therefore, both procedures are favourable surgical options for patients with humeral shaft fractures.",2020,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"['humeral shaft fractures', 'patients with humeral shaft fractures', '63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively']","['LCP fixation', 'LCP', 'interlocking nail (ILN) and locking plate fixation (LCP', 'interlocking nail (ILN', 'Locking compression plate fixation versus intramedullary nailing']","['VAS result', 'UCLA score', 'shoulder function', 'Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS', 'DASH, ASES scores, and SF-36 questionnaires', 'DASH, ASES, and UCLA scores', 'Fracture consolidation', 'pain', 'SF-36 questionnaires and VAS results']","[{'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]",63.0,0.0209717,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Akalın', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey. dryakalin@yahoo.com.'}, {'ForeName': 'İsmail Gökhan', 'Initials': 'İG', 'LastName': 'Şahin', 'Affiliation': 'Turkish Ministry of Health, Edirne Sultan 1. Murat Devlet Hastanesi, Department of Orthopaedics and Traumatology, 22100, Edirne, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Çevik', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Burak Olcay', 'Initials': 'BO', 'LastName': 'Güler', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Avci', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Alpaslan', 'Initials': 'A', 'LastName': 'Öztürk', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04696-6']
1244,32664535,Manipulative Therapy Plus Ankle Therapeutic Exercises for Adolescent Baseball Players with Chronic Ankle Instability: A Single-Blinded Randomized Controlled Trial.,"Manipulative therapies and exercises are commonly used for the management of chronic ankle instability (CAI), but there is no evidence regarding the efficacy of high-velocity low-amplitude manipulation (HVLA) in addition to ankle therapeutic exercise to improve CAI in adolescent baseball players (ABP). To compare the effects of HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone on ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability in ABP with CAI, a single-blinded randomized controlled trial was conducted. A total of 31 ABP with CAI were randomly allocated to the intervention (n = 16) or control (n = 15) groups. The intervention group received HVLA plus resistance exercise twice a week for 4 weeks, while the control group received resistance exercise alone. Ankle status, pain intensity, PPT, ROM, and balance ability were assessed before and after the intervention. The American Orthopedic Foot and Ankle Society scores showed significant group and time interactions (total,  p  = 0.002; pain,  p  < 0.001; alignment,  p  = 0.001). There were significant group and time interactions in pain intensity (resting pain,  p  = 0.008; movement pain,  p  < 0.001). For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026). The unipedal stance of the balance ability showed significant group and time interactions in path length ( p  = 0.006) and velocity ( p  = 0.006). Adding HVLA to resistance exercises may be synergistically effective in improving the ankle status, pain intensity, ROM, and balance ability in ABP with CAI.",2020,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","['A total of 31 ABP with CAI', 'Adolescent Baseball Players with Chronic Ankle Instability', 'adolescent baseball players (ABP']","['Manipulative Therapy Plus Ankle Therapeutic Exercises', 'Manipulative therapies and exercises', 'resistance exercise alone', 'HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone', 'HVLA plus resistance exercise']","['ankle status, pain intensity, ROM, and balance ability', 'time interactions in path length', 'Ankle status, pain intensity, PPT, ROM, and balance ability', 'time interactions in pain intensity (resting pain,  p  = 0.008; movement pain', 'time interactions on dorsiflexion', 'ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}]",31.0,0.0724231,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17144997']
1245,32668833,"Randomized, controlled trial comparing respiratory and analgesic effects of interscalene, anterior suprascapular, and posterior suprascapular nerve blocks for arthroscopic shoulder surgery.","Background


Interscalene brachial plexus block (ISB) provides excellent analgesia for arthroscopic shoulder surgeries but is associated with adverse effects including hemidiaphragmatic paresis. We aimed to compare the respiratory effects, forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1) between suprascapular nerve block (SSB) and ISB.
METHODS


Sixty patients were recruited and randomized into ISB, anterior SSB, and posterior SSB groups. FVC, FEV1, and diaphragmatic excursion were evaluated at baseline and 30 minutes after intervention. Blocks were performed under ultrasound guidance with 15 ml of 0.5% ropivacaine. Pain scores were assessed at 6, 12, and 24 hours postoperatively.
RESULTS


The ISB group showed a reduced FVC of 31.2% ± 17.5% (mean ± SD), while the anterior and posterior SSB groups had less reduction of 3.6% ± 18.6% and 6.8% ± 6.5%, respectively (P < 0.001). The ISB group showed more reduction in diaphragmatic excursion than the anterior and posterior SSB groups (median [IQR]): -85.7% (-95.3% to -63.3%) vs. -1.8% (-13.1% to 2.3%) and -1.2% (-8.8% to 16.8%), respectively (P < 0.001). The median pain scores (IQR) in the ISB and anterior SSB groups were lower than those in the posterior SSB group at 6 hours on movement: 0 (0-2), 1.8 (0-4.5) vs. 5 (2.5-8), respectively (P = 0.002). There was no significant difference in oxycodone consumption postoperatively.
CONCLUSIONS


Anterior SSB preserves lung function and has a comparable analgesic effect as ISB. Thus, it is recommended for arthroscopic shoulder surgeries, especially in patients who have reduced lung function.",2020,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","['patients who have reduced lung function', 'arthroscopic shoulder surgeries', 'Methods\n\n\nSixty patients']","['interscalene block, anterior suprascapular, and posterior suprascapular nerve block', 'posterior SSB', 'ropivacaine', '\n\n\nInterscalene brachial plexus block (ISB']","['oxycodone consumption', 'diaphragmatic excursion', 'Median pain scores (IQR', 'respiratory effects, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), of suprascapular nerve block (SSB', 'forced vital capacity of mean (SD', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0807569,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","[{'ForeName': 'Yean Chin', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Zhao Kun', 'Initials': 'ZK', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'See Seong', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Manohara', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}, {'ForeName': 'Qian Jun', 'Initials': 'QJ', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Changi General Hospital, Singapore.'}]",Korean journal of anesthesiology,['10.4097/kja.20141']
1246,32677452,FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with  FGFR2  rearrangements.,"FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring  FGFR2  fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with  FGFR2  rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration: NCT03656536 (ClinicalTrials.gov).",2020,FGFR2,"['patients with advanced CCA with  FGFR2', 'advanced cholangiocarcinoma with  FGFR2  rearrangements', 'patients with previously treated locally advanced/metastatic CCA harboring  FGFR2  fusions/rearrangements']","['gemcitabine\xa0plus cisplatin', 'FGFR2', 'first-line pemigatinib versus gemcitabine plus cisplatin']","['efficacy and safety', 'progression-free survival', 'objective response rate, overall survival, duration of response, disease control rate, safety\xa0and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0493812,FGFR2,"[{'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Eric Van', 'Initials': 'EV', 'LastName': 'Cutsem', 'Affiliation': 'Department of Oncology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Oncology and Hematology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ioka', 'Affiliation': 'Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Melisi', 'Affiliation': 'Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Research Department of Oncology, UCL Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Department of Medical Oncology, Hammersmith Hospital, Imperial College Health Care Trust, London, UK.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'Lihou', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Ekaterine', 'Initials': 'E', 'LastName': 'Asatiani', 'Affiliation': 'Incyte Biosciences International Sàrl, Morges, Switzerland.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Féliz', 'Affiliation': 'Incyte Biosciences International Sàrl, Morges, Switzerland.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}]","Future oncology (London, England)",['10.2217/fon-2020-0429']
1247,32641012,Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.,"BACKGROUND


Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury.
METHODS


To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O 2  with 60s intervals at 20.9% O 2 ) or daily SHAM (15, 90s episodes at 20.9% O 2  with 60s intervals at 20.9% O 2 ) intervention. The ambulatory group receives either 60-min walking practice (WALK), daily AIH + WALK, or daily SHAM+WALK intervention. Our primary outcome measures assess overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test). For safety, we also measure levels of pain, spasticity, systemic hypertension, and autonomic dysreflexia. We record outcome measures at baseline, days 5 and 10, and follow-ups at 1 week, 1 month, 6 months, and 12 months post-treatment.
DISCUSSION


The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.",2020,More persistent walking recovery may occur following repetitive (weeks),"['85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group', 'persons with SCI', 'persons with subacute spinal cord injury', 'persons with more acute SCI', 'persons with chronic (>\u20091\u2009year) SCI', 'persons with traumatic, subacute SCI', 'persons with sub-acute SCI (<\u200912\u2009months) SCI', 'persons recovering from traumatic incomplete spinal cord injury (SCI']","['Daily acute intermittent hypoxia', 'SHAM', '60-min walking practice (WALK), daily AIH\u2009+\u2009WALK, or daily SHAM+WALK intervention', 'placebo']","['walking function', 'overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test', 'pain, spasticity, systemic hypertension, and autonomic dysreflexia']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021589', 'cui_str': 'Artificial insemination, homologous'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}]",85.0,0.134924,More persistent walking recovery may occur following repetitive (weeks),"[{'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Naidu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Peters', 'Affiliation': 'Department of Rehabilitation & Movement Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Andrew Q', 'Initials': 'AQ', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Barth', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Crane', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Link', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Hayes', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Slocum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Trumbower', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA. randy.trumbower@mgh.harvard.edu.'}]",BMC neurology,['10.1186/s12883-020-01851-9']
1248,32644104,Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer: A Post Hoc Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.,"Importance


Despite numerous published phase 3 trials, the association of treatment adherence with outcomes for patients with rectal cancer remains largely unexplored.
Objective


To analyze the association of treatment adherence with disease-free survival (DFS) among patients with rectal cancer in the CAO/ARO/AIO-04 trial.
Design, Setting, and Participants


This post hoc analysis of a phase 3 randomized clinical trial was conducted from July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma. Statistical analysis was performed from May 5, 2019, to February 2, 2020.
Interventions


A total of 625 patients received neoadjuvant fluorouracil-based chemoradiotherapy (nCRT), and a total of 607 patients received fluorouracil-based nCRT with addition of oxaliplatin. Of the 1126 patients who underwent curative surgery, 439 started fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin.
Main Outcomes and Measures


The association of adherence with nCRT and adjuvant chemotherapy with DFS was assessed in both groups in the as-treated population.
Results


Among the 625 patients (442 men; mean age, 63.0 years) who received fluorouracil nCRT and the 607 patients (430 men; mean age, 63.0 years) who received fluorouracil-based nCRT with addition of oxaliplatin, after a median follow-up of 50 months (interquartile range, 38-61 months), 3-year DFS in the as-treated population was 71.1% in the fluorouracil group and 75.8% in the fluorouracil-oxaliplatin group (hazard ratio [HR], 0.803; 95% CI, 0.651-0.990; P = .04). Overall, 419 patients in the fluorouracil nCRT group (67.0%) and 434 patients in the fluorouracil-oxaliplatin nCRT group (71.5%) received full doses of preoperative nCRT. Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the fluorouracil-oxaliplatin group (32.0%) received full doses of adjuvant chemotherapy. Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses. In contrast, adjuvant chemotherapy was not associated with DFS in both the fluorouracil group (complete vs near complete: HR, 0.900; 95% CI, 0.559-1.448; P = .66; complete vs incomplete: HR, 1.057; 95% CI, 0.807-1.386; P = .69) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.155; 95% CI, 0.716-1.866; P = .56; complete vs incomplete: HR, 1.073; 95% CI, 0.790-1,457; P = .65).
Conclusions and Relevance


To our knowledge, this is the first analysis of a phase 3 trial to assess the association of treatment adherence with some clinical outcomes for patients with rectal cancer. The findings emphasize the need for appropriate trial design with optimized nCRT dose and schedule and supportive strategies to facilitate good adherence and precision delivery, especially for intensified nCRT.
Trial Registration


ClinicalTrials.gov Identifier: NCT00349076.",2020,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","['patients with rectal cancer in the CAO/ARO/AIO-04 trial', '625 patients (442 men; mean age, 63.0 years) who received', 'patients with rectal cancer', '419 patients in the', 'July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma', 'Patients With Rectal Cancer', 'Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the', '1126 patients who underwent curative surgery, 439 started', '625 patients received', 'and the 607 patients (430 men; mean age, 63.0 years) who received']","['fluorouracil-based nCRT with addition of oxaliplatin', 'fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin', 'fluorouracil-oxaliplatin', 'fluorouracil-oxaliplatin nCRT', 'fluorouracil', 'adjuvant chemotherapy', 'fluorouracil nCRT', 'neoadjuvant fluorouracil-based chemoradiotherapy (nCRT']","['association of adherence with nCRT and adjuvant chemotherapy with DFS', '3-year DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",625.0,0.204208,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Diefenhardt', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Ethan B', 'Initials': 'EB', 'LastName': 'Ludmir', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Department of Medical Oncology, University Hospital Mannheim, University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral, and Pediatric Surgery, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Minsky', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2394']
1249,32644110,Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial.,"Importance


A significant proportion of patients with early-stage triple-negative breast cancer (TNBC) are treated with neoadjuvant chemotherapy. Sequencing of circulating tumor DNA (ctDNA) after surgery, along with enumeration of circulating tumor cells (CTCs), may be used to detect minimal residual disease and assess which patients may experience disease recurrence.
Objective


To determine whether the presence of ctDNA and CTCs after neoadjuvant chemotherapy in patients with early-stage TNBC is independently associated with recurrence and clinical outcomes.
Design, Setting, and Participants


A preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice. Patients had blood samples collected for ctDNA and CTCs at time of treatment assignment; ctDNA analysis with survival was performed for 142 patients, and CTC analysis with survival was performed for 123 patients. Median clinical follow-up was 17.2 months (range, 0.3-58.3 months).
Interventions


Circulating tumor DNA was sequenced using the FoundationACT or FoundationOneLiquid Assay, and CTCs were enumerated using an epithelial cell adhesion molecule-based, positive-selection microfluidic device.
Main Outcomes and Measures


Primary outcomes were distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS).
Results


Among 196 female patients (mean [SD] age, 49.6 [11.1] years), detection of ctDNA was significantly associated with inferior DDFS (median DDFS, 32.5 months vs not reached; hazard ratio [HR], 2.99; 95% CI, 1.38-6.48; P = .006). At 24 months, DDFS probability was 56% for ctDNA-positive patients compared with 81% for ctDNA-negative patients. Detection of ctDNA was similarly associated with inferior DFS (HR, 2.67; 95% CI, 1.28-5.57; P = .009) and inferior OS (HR, 4.16; 95% CI,1.66-10.42; P = .002). The combination of ctDNA and CTCs provided additional information for increased sensitivity and discriminatory capacity. Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009). At 24 months, DDFS probability was 52% for patients who were ctDNA positive and CTC positive compared with 89% for those who were ctDNA negative and CTC negative. Similar trends were observed for DFS (HR, 3.15; 95% CI, 1.07-9.27; P = .04) and OS (HR, 8.60; 95% CI, 1.78-41.47; P = .007).
Conclusions and Relevance


In this preplanned secondary analysis of a randomized clinical trial, detection of ctDNA and CTCs in patients with early-stage TNBC after neoadjuvant chemotherapy was independently associated with disease recurrence, which represents an important stratification factor for future postneoadjuvant trials.
Trial Registration


ClinicalTrials.gov Identifier: NCT02101385.",2020,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","['With Triple-Negative Breast Cancer', 'Patients', 'patients with early-stage TNBC', 'patients with early-stage TNBC after', '196 female patients (mean [SD] age, 49.6 [11.1] years', 'Participants\n\n\nA preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice', 'patients with early-stage triple-negative breast cancer (TNBC']",['neoadjuvant chemotherapy'],"['DDFS probability', 'inferior DDFS', 'Circulating Tumor DNA and Circulating Tumor Cells', 'distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS']","[{'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",196.0,0.30666,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","[{'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Radovich', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Guanglong', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Hancock', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chitambar', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Filipa C', 'Initials': 'FC', 'LastName': 'Lynce', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Blaya', 'Affiliation': 'Memorial Healthcare System, Hollywood, Florida.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Walling', 'Affiliation': 'Community Regional Cancer Care, Indianapolis, Indiana.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Daily', 'Affiliation': 'University of Florida, Gainesville.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Mahtani', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Advocate Aurora Health Care, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Erlanger Health System, Chattanooga, Tennessee.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Dean C', 'Initials': 'DC', 'LastName': 'Pavlick', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Albacker', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gregg', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Solzak', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Bales', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Cantor', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Anna Maria V', 'Initials': 'AMV', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Badve', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Savran', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2295']
1250,32651338,"A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.","BACKGROUND


Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.
OBJECTIVE


Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration.
METHODS


This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.
RESULTS


The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were nonsignificant changes from baseline for all groups.
CONCLUSIONS


D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).",2020,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","['stroke survivors with gait impairment', '377 of planned 540 patients enrolled, due to no treatment effect', 'ischemic stroke']","['Dalfampridine extended release tablets (D-ER', '7.5\u200amg D-ER, 10\u200amg D-ER, or placebo', 'D-ER', 'dalfampridine', 'placebo']","['distances walked', '2-minute walk test (2\u200aMinWT', 'walking deficits']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",540.0,0.674871,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Page', 'Affiliation': 'RehabLab™, Neurorecovery Unlimited, LLC, Columbus, OH, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Bockbrader', 'Affiliation': 'Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'JEM Research Institute, Atlantis, FL, USA.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Finklestein', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'MingMing', 'Initials': 'M', 'LastName': 'Ning', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Waleed H', 'Initials': 'WH', 'LastName': 'El-Feky', 'Affiliation': 'Texas Neurology, Dallas, TX, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Wilson', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Restorative neurology and neuroscience,['10.3233/RNN-201009']
1251,32657920,Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up.,"OBJECTIVE


The aim of this study was to compare silicone-banded sleeve gastrectomy (BSG) to nonbanded sleeve gastrectomy (SG) regarding weight loss, obesity-related comorbidities, and complications.
SUMMARY BACKGROUND DATA


As a primary bariatric procedure, SG leads to excellent weight loss, yet weight regain is a relevant issue in mid- to long-term follow-up. Retrospective analyses suggest that banding a sleeve using a silicone ring may decrease weight regain and improve weight loss.
METHODS


The banded versus nonbanded sleeve gastrectomy single-center, randomized controlled trial was conducted from January 2015 to August 2019. The primary endpoint was defined as excess weight loss 3 years after surgery. Secondary endpoints included the surgery's impact on obesity-related comorbidities, quality of life, and complications. The study was registered under DRKS00007729.
RESULTS


Among 94 patients randomized, 97% completed 3-year follow-up. Mean initial body mass index was 50.9 kg/m [95% confidence interval (CI), 49.6-52.2]. Mean adjusted excess weight loss 3 years after SG amounted to 62.3% (95% CI, 56.2-68.5) and 73.9% ( 95% CI, 67.8-80.0) after BSG (difference 11.6%, P = 0.0073). Remission of type 2 diabetes occurred in 66.7% (4/6) after SG and in 91.0% (10/11) following BSG (P = 0.21). Three years after surgery, ring implantation correlated with decreased frequency of symptomatic reflux episodes (P = 0.01) but increased frequency of regurgitation (P = 0.03). The rate of major complications was not different between the study groups (BSG, n = 3; SG, n = 2; P = 0.63). Quality of life was better following BSG (P = 0.001).
CONCLUSIONS


BSG provided better weight loss than nonbanded SG 3 years after surgery. Regurgitation was the main clinically relevant negative effect after BSG.",2020,"Quality of life was better following BSG (P = 0.001).
","['94 patients randomized, 97% completed 3-year follow-up']","['banded versus nonbanded sleeve gastrectomy single-center', 'Banded Versus Nonbanded Sleeve Gastrectomy', 'silicone-banded sleeve gastrectomy (BSG', 'nonbanded sleeve gastrectomy (SG']","['Remission of type 2 diabetes', 'frequency of symptomatic reflux episodes', 'Mean initial body mass index', 'weight regain and improve weight loss', 'Mean adjusted excess weight loss 3 years after SG', 'frequency of regurgitation', 'weight loss', ""surgery's impact on obesity-related comorbidities, quality of life, and complications"", 'excess weight loss 3 years after surgery', 'Quality of life', 'rate of major complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",94.0,0.15993,"Quality of life was better following BSG (P = 0.001).
","[{'ForeName': 'Jodok M', 'Initials': 'JM', 'LastName': 'Fink', 'Affiliation': 'Department of General and Visceral Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hetzenecker', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': ''}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Runkel', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Laessle', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fichtner-Feigl', 'Affiliation': ''}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marjanovic', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004174']
1252,32672800,Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial.,"Importance


The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear.
Objective


To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.
Design, Setting, and Participants


This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.
Interventions


Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.
Main Outcomes and Measures


Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.
Results


Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001). Participants in the combination group received fewer ranibizumab injections (median, 6.0 [interquartile range (IQR), 4.0-11.0]) than the monotherapy group (median, 12.0 [IQR, 7.0-17.0]) up to month 24. The combination group required a median of 2.0 (IQR, 1.0-3.0) vPDT treatments for 24 months, with 75 of 168 participants (44.6%) requiring only 1 vPDT treatment.
Conclusions and Relevance


The 24-month data findings confirm that ranibizumab therapy, given as monotherapy or in combination with vPDT, is efficacious and safe for treatment of PCV. Combination therapy with vPDT added to ranibizumab achieved superior BCVA gain, increased odds of complete polypoidal lesion regression, and fewer treatment episodes compared with ranibizumab monotherapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01846273.",2020,Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001).,"['participants with polypoidal choroidal vasculopathy (PCV', 'Polypoidal Choroidal Vasculopathy', 'Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography', '322 participants (mean [SD] age', 'Interventions\n\n\nParticipants (N\u2009=\u2009322', 'participants with PCV for 24 months']","['vPDT', 'vPDT (combination group) or sham PDT (monotherapy', 'ranibizumab injections', 'ranibizumab', 'ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy', 'verteporfin photodynamic therapy (vPDT', 'ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n\u2009=\u2009168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy', 'Ranibizumab With or Without Verteporfin Photodynamic Therapy', 'ranibizumab monotherapy']","['superior BCVA gain', 'key clinical outcomes, treatment exposure, and safety', 'visual acuity (BCVA) gains', '2-year efficacy and safety', 'complete polypoidal lesion regression']","[{'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0430879', 'cui_str': 'Indocyanine green angiography'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0387288', 'cui_str': 'Verteporfin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",,0.24727,Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001).,"[{'ForeName': 'Tock H', 'Initials': 'TH', 'LastName': 'Lim', 'Affiliation': 'National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Timothy Y Y', 'Initials': 'TYY', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tien Y', 'Initials': 'TY', 'LastName': 'Wong', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore.'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Paisan', 'Initials': 'P', 'LastName': 'Ruamviboonsuk', 'Affiliation': 'Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Colin S', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': ""Department of Ophthalmology, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Chui Ming Gemmy', 'Initials': 'CMG', 'LastName': 'Cheung', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore.'}, {'ForeName': 'Nor Fariza', 'Initials': 'NF', 'LastName': 'Ngah', 'Affiliation': 'Department of Ophthalmology, Hospital Shah Alam, Malaysia.'}, {'ForeName': 'Ramune', 'Initials': 'R', 'LastName': 'Patalauskaite', 'Affiliation': 'Novartis Ireland Ltd, Dublin, Ireland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Margaron', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Camden Medical Centre, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2443']
1253,32681455,Cerebellar Intermittent Theta-Burst Stimulation Combined with Vestibular Rehabilitation Improves Gait and Balance in Patients with Multiple Sclerosis: a Preliminary Double-Blind Randomized Controlled Trial.,"Difficulties in gait and balance disorders are among the most common mobility limitations in multiple sclerosis (MS), mainly due to a damage of cerebellar circuits. Moreover, the cerebellum plays a critical role in promoting new motor tasks, which is an essential function for neurorehabilitation. In this study, we investigated the effects of cerebellar intermittent theta burst stimulation (c-iTBS), a high-frequency rTMS protocol able to increase cerebellar activity, on gait and balance in a sample of 20 hospitalized participants with MS, undergoing vestibular rehabilitation (VR), an exercise-based program primarily designed to reduce vertigo and dizziness, gaze instability, and/or imbalance and falls in MS. Patients were assigned to receive either c-iTBS or sham iTBS before being treated with VR during 2 weeks. VR consisted of two types of training: gaze stability and postural stability exercises. The primary outcome measure was the change from baseline in the Tinetti Balance and Gait scale (TBG). The secondary outcome measures were changes from baseline in Berg Balance Scale (BBS), Fatigue Severity Scale (FSS), Two Minute Walking Test (2MWT), and Timed 25-ft walk test (T25FW) scales. MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR. Moreover, MS patients in the c-iTBS groups showed better performances in the vestibular-ocular reflex exercises. Combined c-iTBS and VR improves gait and balance abilities more than standard VR treatment in MS patients with a high level of disability.",2020,MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR.,"['20 hospitalized participants with MS, undergoing vestibular rehabilitation (VR', 'MS patients with a high level of disability', 'Patients with Multiple Sclerosis']","['Cerebellar Intermittent Theta-Burst Stimulation Combined with Vestibular Rehabilitation', 'Combined c-iTBS and VR', 'c-iTBS or sham iTBS', 'cerebellar intermittent theta burst stimulation (c-iTBS', 'training: gaze stability and postural stability exercises']","['cerebellar activity', 'Tinetti Balance and Gait scale (TBG', 'gait and balance abilities', 'Gait and Balance', 'vertigo and dizziness, gaze instability, and/or imbalance and falls in MS', 'TBG', 'changes from baseline in Berg Balance Scale (BBS), Fatigue Severity Scale (FSS), Two Minute Walking Test (2MWT), and Timed 25-ft walk test (T25FW) scales']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2732846', 'cui_str': 'Tinetti balance and gait scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",20.0,0.0318511,MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Grasso', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Soldi', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Elias Paolo', 'Initials': 'EP', 'LastName': 'Casula', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bonnì', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mastrogiacomo', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': ""D'Acunto"", 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Porrazzini', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy. g.koch@hsantalucia.it.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01166-y']
1254,33066601,Acute Effects of Self-Selected Music Intervention on Golf Performance and Anxiety Level in Collegiate Golfers: A Crossover Study.,"Music has been reported as a positive intervention for improving psychophysiological conditions and exercise performance. However, the effects of music intervention on golf performance in association with psychophysiological responses have not been well examined in the literature. The purpose of the study was to investigate the acute effects of self-selected music intervention on golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety. Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years). A cross-over and within-subject design was used in this study. Participants performed a non-music trial (T1), pre-exercise music trial (T2), and simultaneous music trial (T3) in a randomized order with 48-72 h apart. The participants were attached to a HR monitor to record the HR and HRV during the measurement. The golf swing and putting performance was assessed by using the Golfzon golf simulator system. The state-trait anxiety inventory-state questionnaire (STAI-S) was used to evaluate anxiety state. All measurements were taken during baseline (phase one) and after resting or music intervention (phase two). Repeated measurement of analysis of variance (ANOVA) and Cohen's effect size (ES) were used for statistical analyses. The results show no significant differences in golf swing and putting performance ( p  > 0.05). However, significant decrease in STAI-S score was found in T2 ( p  = 0.047, ES = 0.32). A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05). In conclusion, a single pre-exercise or simultaneous self-selected music intervention contributes minor effects to golf performance in collegiate golfers. The positive benefits of self-selected music intervention on the psychological condition and cardia-related modulation while practicing golf is warranted.",2020,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","['Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years', 'Collegiate Golfers']","['Self-Selected Music Intervention', 'self-selected music intervention', 'music intervention']","['STAI-S score', 'golf swing and putting performance', 'standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2', 'Golf Performance and Anxiety Level', 'golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety', 'state-trait anxiety inventory-state questionnaire (STAI-S']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0512171,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","[{'ForeName': 'Hung-Tsung', 'Initials': 'HT', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Hsia-Ling', 'Initials': 'HL', 'LastName': 'Tai', 'Affiliation': 'Department of Physical Education, University of Taipei, Taipei 10048, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17207478']
1255,32653333,Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.,"STUDY OBJECTIVE


Acute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial.
METHODS


Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded.
RESULTS


Among 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%).
CONCLUSION


Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.",2020,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","['Acute Urticaria', '262 enrolled patients', 'Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous']","['antihistamine', 'intravenous cetirizine 10 mg or intravenous diphenhydramine', 'diphenhydramine', 'cetirizine', 'Intravenous Cetirizine', 'Diphenhydramine']","['baseline sedation score', 'adverse event rate', 'Frequency of sedation and anticholinergic adverse effects', '2-hour pruritus score change', '2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers', 'mean time spent']","[{'cui': 'C0234935', 'cui_str': 'Acute urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1551285', 'cui_str': 'Urgent care clinic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",262.0,0.0952898,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","[{'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: benjamin.abella@pennmedicine.upenn.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Berger', 'Affiliation': 'Allergy and Asthma Associates of Southern California, Mission Viejo, CA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Blaiss', 'Affiliation': 'Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta, GA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Stiell', 'Affiliation': 'Department of Emergency Medicine, University of Ottawa and Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Herres', 'Affiliation': 'Department of Emergency Medicine, Einstein Healthcare Network, Philadelphia, PA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Moellman', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Suner', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kessler', 'Affiliation': 'Department of Emergency Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Klausner', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'Department of Emergency Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'TerSera Therapeutics, Deerfield, IL.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.05.025']
1256,32656664,"Effects of caffeine intake on the biomechanical properties of the cornea: a placebo-controlled, double-blind, crossover pilot study in low caffeine consumers.","PURPOSE


To assess the short-term effects of caffeine intake on the biomechanical properties of the cornea, as well as its possible association with the intraocular pressure (IOP), as measured by corneal visualization Scheimpflug technology (CorVis ST) in healthy subjects.
METHODS


Twenty-two low caffeine consumers ingested either a caffeine (4 mg/Kg) or placebo capsule in two separate sessions. IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD), were measured with the Corvis ST before and after 30 min, 60 min, and 90 min of caffeine/placebo intake.
RESULTS


Caffeine intake reduced the corneal deformability, inducing significant changes in A1T, A2V, A2T, HCDA, HCT, and PD (all p values < 0.05). Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively). Also, the changes in IOP after caffeine intake were positively associated with A1T (r = 0.790 to 0.962), and negatively associated with A2T (r = - 0.230 to - 0.722) and PD (r = - 0.506 to - 0.644).
CONCLUSIONS


Caffeine intake reduces the corneal deformability, with these changes being partially associated with the IOP rise. These findings evidence that exogenous factors such as caffeine intake should be taken into consideration when making clinical decisions that are based on the biomechanical properties of the cornea.",2020,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","['healthy subjects', 'low caffeine consumers', 'Twenty-two low caffeine consumers ingested either a']","['caffeine intake', 'caffeine', 'caffeine/placebo', 'caffeine (4\xa0mg/Kg) or placebo capsule', 'placebo']","['biomechanical properties of the cornea', 'IOP values', 'changes in IOP', 'IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD', 'A1T, A2V, A2T, HCDA, HCT, and PD', 'intraocular pressure (IOP', 'corneal deformability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0625485', 'cui_str': '5,9-hexacosadienoic acid'}]",22.0,0.0561261,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","[{'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain. beatrizrc@ugr.es.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04835-0']
1257,32660260,Efficacy of an Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation in Persistent Atrial Fibrillation Without a Left Atrial Low-Voltage Area.,"BACKGROUND


Electrical remodeling precedes structural remodeling. In adjunctive left atrial (LA) low-voltage area (LVA) ablation to pulmonary vein isolation of atrial fibrillation (AF), LA areas without LVA have not been targeted for ablation. We studied the effect of adjunctive LA posterior wall isolation (PWI) on persistent AF without LA-LVA according to electrophysiological testing (EP test).
METHODS


We examined consecutive patients with persistent AF with (n=33) and without (n=111) LA-LVA. Patients without LA-LVA were randomly assigned to EP test-guided (n=57) and control (n=54) groups. In the EP test-guided group, an adjunctive PWI was performed in those with positive results (PWI subgroup; n=24), but not in those with negative results (n=33). The criteria for positive EP tests were an effective refractory period ≤180 ms, effective refractory period>20 ms shorter than the other sites, and/or induction of AF/atrial tachycardia (AT) during measurements. LVA ablation was performed in the patients with LA-LVA.
RESULTS


During the follow-up period (62±33 weeks), the EP test-guided group had significantly lower recurrence rates (19%,11/57 versus 41%, 22/54,  P =0.012) and higher Kaplan-Meier AF/AT-free survival curve rates than the control group ( P =0.01). No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed. Therefore, PWI for positive EP tests reduced the AF/AT recurrence in the EP test-guided group. A stepwise Cox proportional hazard analyses identified EP test-guided ablation as a factor reducing the recurrence rate. The recurrence rates in the LA-LVA ablation group and EP test-guided group were similar.
CONCLUSIONS


This pilot study proposed that an EP test-guided adjunctive PWI of persistent AF without LA-LVA potentially reduced AF/AT recurrences. The results suggest that there is an AF substrate in the LA with altered electrophysiological function even when there is no LA-LVA. Graphic Abstract: A graphic abstract is available for this article.",2020,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"['Patients without LA-LVA', 'consecutive persistent AF patients with (n=33) and without (n=111) LA-LVA']","['Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation', 'adjunctive LA posterior wall isolation (PWI', 'LA-LVA ablation', 'EP test-guided', 'adjunctive left atrial (LA) low-voltage area (LVA) ablation', 'LVA ablation']","['recurrence and AF/AT-free survival curve rates', 'AF/AT recurrence', 'recurrence rates', 'recurrence rate', 'higher Kaplan-Meier AF/AT-free survival curve rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0273246,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"[{'ForeName': 'Hirosuke', 'Initials': 'H', 'LastName': 'Yamaji', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Higashiya', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Hina', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Shigeshi', 'Initials': 'S', 'LastName': 'Kamikawa', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirohata', 'Affiliation': 'Department of Medical Technology, Okayama University Graduate School of Health Sciences, Japan (S. Hirohata, S. Kusachi).'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Kusachi', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008191']
1258,32667635,Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial.,"Importance


Although standardization of pancreaticoduodenectomy (PD) has improved postoperative outcomes, morbidity remains high. Fast-track surgery programs appear to improve morbidity, and avoiding nasogastric tube decompression (NGTD), already outdated in most major abdominal surgery, is strongly suggested after PD by fast-track surgery programs but lacks high-level evidence, especially regarding safety.
Objective


To assess in a randomized clinical trial whether the absence of systematic NGTD after PD reduces postoperative complications.
Design, Setting, and Participants


The IPOD study (Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy) was an open-label, prospective, single-center, randomized clinical trial conducted at a high-volume pancreatic surgery university hospital in France. In total, 155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility. Key exclusion criteria were previous gastric or esophageal surgery and severe comorbidities. Patients were randomly assigned (1:1) to systematic NGTD or to no nasogastric decompression and were followed up until 90 days after surgery.
Interventions


For patients without NGTD, the NGT was removed immediately after surgery, whereas for patients with NGTD, the NGT was removed 3 to 5 days after surgery.
Main Outcomes and Measures


The primary end point was the occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification. The primary end point and safety were evaluated in the intent-to-treat population.
Results


From January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n = 52) or to NGTD (n = 59). No patient was lost to follow-up. The 2 groups had similar patient demographic and clinical characteristics at baseline. The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males). The postoperative complication rates grade II or higher were similar between the 2 groups (risk ratio, 0.99; 95% CI, 0.66-1.47; P > .99). Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups. Median (interquartile) length of hospital stay for patients without NGTD was not significantly different compared with those with NGTD (10.0 [9.0-16.3] vs 12.0 [10.0-16.0] days; P = .14).
Conclusions and Relevance


The present study found no significant difference in postoperative complication occurrence of Clavien-Dindo classification grade II or higher between systematic NGTD and no NGTD after PD, suggesting that avoiding systematic nasogastric decompression is safe for this indication.
Trial Registration


ClinicalTrials.gov Identifier: NCT02594956.",2020,"Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups.","['patients without NGTD', '155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility', 'From January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n\u2009=\u200952) or to NGTD (n\u2009=\u200959', 'high-volume pancreatic surgery university hospital in France', 'The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males']","['pancreaticoduodenectomy (PD', 'Nasogastric Decompression vs No Decompression', 'Nasogastric Decompression', 'systematic NGTD or to no nasogastric decompression', 'Fast-track surgery programs']","['Pulmonary complication rates', 'Median (interquartile) length of hospital stay', 'occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification', 'delayed gastric emptying rates', 'postoperative complication rates grade II or higher']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]",155.0,0.200993,"Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups.","[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bergeat', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Merdrignac', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Robin', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Gaignard', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rayar', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': 'University of Rennes, Rennes, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Boudjema', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': 'University of Rennes, Rennes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Sulpice', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}]",JAMA surgery,['10.1001/jamasurg.2020.2291']
1259,32667647,Randomized Clinical Trial of Nasogastric Tube Placement After Pancreaticoduodenectomy.,,2020,,[],['Nasogastric Tube Placement After Pancreaticoduodenectomy'],[],[],"[{'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]",[],,0.12009,,"[{'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Sharib', 'Affiliation': 'Division of General Surgery, Section of Surgical Oncology and Hepatopancreaticobiliary Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Eric K', 'Initials': 'EK', 'LastName': 'Nakakura', 'Affiliation': 'Division of General Surgery, Section of Surgical Oncology and Hepatopancreaticobiliary Surgery, Department of Surgery, University of California, San Francisco.'}]",JAMA surgery,['10.1001/jamasurg.2020.2305']
1260,32666905,Development and application of an electronic treatment register: a system for enumerating populations and monitoring treatment during mass drug administration.,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration. The electronic treatment register was designed in xlsform, deployed via the SurveyCTO mobile data collection platform, and implemented on smartphones running the Android operating system. The versatile system enables collection of census and treatment status information, facilitates data aggregation and visualisation, and permits real-time feedback loops during implementation of mass drug administration. Here we describe the system's design and use within the DeWorm3 Project and key features, and by sharing the register here, we hope our readers will further explore its use within their research and disease-control activities.",2020,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.",[],[],[],[],[],[],,0.0575259,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Oswald', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Kennedy', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Farzana', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Saravanakumar Puthupalayam', 'Initials': 'SP', 'LastName': 'Kaliappan', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Eloic', 'Initials': 'E', 'LastName': 'Atindegla', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Parfait', 'Initials': 'P', 'LastName': 'Houngbégnon', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chisambi', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Witek-McManus', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Galagan', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Emmanuel-Fabula', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Legge', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Yard', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Moudachirou', 'Initials': 'M', 'LastName': 'Ibikounlé', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Sitara Swarna Rao', 'Initials': 'SSR', 'LastName': 'Ajjampur', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Arianna Rubin', 'Initials': 'AR', 'LastName': 'Means', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Kristjana H', 'Initials': 'KH', 'LastName': 'Ásbjörnsdóttir', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Halliday', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Judd L', 'Initials': 'JL', 'LastName': 'Walson', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}]",Global health action,['10.1080/16549716.2020.1785146']
1261,32665531,TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial.,"OBJECTIVE


The aim of the study was to evaluate the clinically meaningful effect of oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules on hot flushes severity (vasomotor symptoms [VMS] severity scale) using the patient-reported Clinical Global Impression (CGI).
METHODS


REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial that evaluated TX-001HR in postmenopausal women (40-65 y) with a uterus. Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized in a VMS substudy to daily E2/P4 (1/100, 0.5/100, 0.5/50, or 0.25/50 mg/mg), or placebo. Patients rated VMS severity from 1 (mild) to 3 (severe) and symptom improvements with the CGI. CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
RESULTS


In the VMS substudy (n = 726), determined CID and minimal CID severity thresholds were reductions of 0.525 and 0.350 points at week 4, respectively, and 0.775 and 0.225 points at week 12. Significantly more women taking the two highest E2/P4 doses (1/100 and 0.5/100) versus placebo met CID severity thresholds at weeks 4 (40% and 44% vs 17%; P < 0.05) and 12 (56% and 48% vs 29%; P < 0.05).
CONCLUSION


REPLENISH trial data demonstrated that E2/P4 1/100 and 0.5/100 provided clinically meaningful improvements in hot flushes severity in postmenopausal women. In conjunction with previously demonstrated clinically meaningful VMS frequency improvements, these data support oral E2/P4 1/100 and 0.5/100 for postmenopausal women with a uterus seeking treatment for moderate to severe VMS.",2020,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","['postmenopausal women (40-65 y) with a uterus', 'Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk', 'postmenopausal women', 'postmenopausal women with a uterus seeking treatment for moderate to severe VMS']","['TX-001HR', 'oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules', 'placebo']","['hot flushes severity (vasomotor symptoms [VMS] severity scale', 'CID and minimal CID severity thresholds', 'CID severity thresholds', 'VMS severity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.432405,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","[{'ForeName': 'Ginger D', 'Initials': 'GD', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Revicki', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001602']
1262,32670627,Feasibility of implementing a novel behavioural smoking cessation intervention amongst human immunodeficiency virus-infected smokers in a resource-limited setting: A single-arm pilot trial.,"Background


Tobacco use is prevalent amongst individuals infected with human immunodeficiency virus (HIV). In resource-constrained settings, pharmacological smoking cessation interventions are unfeasible because of their high cost. There is a need to develop and evaluate behavioural interventions to address the unique challenges of tobacco use in the HIV-infected populations in these settings.
Objectives


The authors aimed to assess the feasibility and acceptability of the Behavioural Activation/Problem Solving for Smoking Cessation (BAPS-SC) intervention programme to determine whether it should be tested in an adequately powered randomised controlled trial.
Method


The authors merged behavioural activation therapy (BAT) with the principles of problem-solving therapy to create a novel five-session counselling model to address the unique challenges of tobacco cessation amongst those infected with HIV. Feasibility measures included the rate of enrolment amongst those eligible and the retention rate and descriptive analysis of intervention acceptability. The authors' secondary outcome was 7-day point smoking prevalence abstinence, confirmed with breath carbon monoxide.
Results


A total of 128 individuals were screened over 8 weeks with 50 deemed eligible and 40 enrolled (80%). Retention at week 12 was 53% (21/40). The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40). All respondents indicated that they would recommend BAPS-SC to other smokers who want to quit, and would be willing to participate in the programme again up to the point of exit if they did not stop smoking.
Conclusion


A full-scale randomised control trial comparing BAPS-SC with usual practice is warranted to evaluate the efficacy of this novel intervention in these settings.",2020,"The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40).","['individuals infected with human immunodeficiency virus (HIV', 'human immunodeficiency virus-infected smokers in a resource-limited setting', '128 individuals were screened over 8 weeks with 50 deemed eligible and 40 enrolled (80']","['BAPS-SC', 'behavioural activation therapy (BAT', 'implementing a novel behavioural smoking cessation intervention', 'Behavioural Activation/Problem Solving for Smoking Cessation (BAPS-SC) intervention programme']","['7-day point smoking prevalence abstinence, confirmed with breath carbon monoxide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",128.0,0.104967,"The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40).","[{'ForeName': 'Billy M', 'Initials': 'BM', 'LastName': 'Tsima', 'Affiliation': 'Department of Family Medicine and Public Health, Faculty of Medicine, University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Moedi', 'Affiliation': 'Princess Marina Hospital, Dental Department, Gaborone, Botswana.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Maunge', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kitso', 'Initials': 'K', 'LastName': 'Machangane', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Kgogwane', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Tebogo', 'Initials': 'T', 'LastName': 'Mudojwa', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bastian', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Bilker', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine (ID), Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}]",Southern African journal of HIV medicine,['10.4102/sajhivmed.v21i1.1075']
1263,32672570,Outcomes of the Shunt Tube Exposure Prevention Study: A Randomized Clinical Trial.,"PURPOSE


To compare the long-term safety and efficacy of amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts in reducing glaucoma shunt tube exposure.
DESIGN


Multicenter, prospective, randomized clinical trial.
PARTICIPANTS


Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation.
METHODS


Patients were randomized to receive GDD with either AM-UC or pericardium patch grafts to cover GDD tubes. Patients were followed up clinically with anterior segment (AS) OCT to assess patch graft stability and host-tissue integration prospectively.
MAIN OUTCOME MEASURES


Tube exposure, graft thinning, and graft-related complications.
RESULTS


A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n = 72) or Ahmed valve (n = 9). Tubes were inserted in the anterior chamber (n = 71), sulcus (n = 6), or pars plana (n = 4). Tube ligation was performed with Baerveldt GDD along with fenestration (n = 51) or orphan trabeculectomy (n = 21). Tubes were covered with AM-UC (n = 41) or pericardium (n = 40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in 1 eye (2%) in the AM-UC group at 3 months and in 2 eyes (5%) in the pericardium group at 2 and 6 months (P = 0.54). Sequential AS OCT showed better host-tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤3 months) occurred in 5 eyes (12%) in the AM-UC group and in 17 eyes (43%) in the pericardium group (P = 0.002). Late thinning occurred in 2 eyes (5%) and 11 eyes (28%) in the AM-UC and pericardium groups, respectively (P = 0.007). Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.
CONCLUSIONS


Amniotic membrane-umbilical cord grafts are well tolerated and offer an alternative to pericardium for safe and stable tube shunt coverage. Its high-tensile strength, low immunogenicity, and excellent host-tissue integration significantly reduced graft thinning.",2019,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"['Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation', 'Patients', 'A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n\xa0= 72) or Ahmed valve (n']","['amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts', 'AM-UC', 'Tube ligation was performed with Baerveldt GDD along with fenestration (n\xa0= 51) or orphan trabeculectomy', 'GDD with either AM-UC or pericardium patch grafts to cover GDD tubes']","['graft rejection or infection', 'Tube exposure, graft thinning, and graft-related complications', 'graft thinning', 'Tube exposure', 'Early graft thinning', 'host-tissue integration', 'Late thinning', 'Graft translucency and cosmetic appearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0031050', 'cui_str': 'Pericardial sac structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",81.0,0.0452362,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"[{'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Sheha', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York; Herbert Wertheim College of Medicine, Florida International University, Miami, Florida. Electronic address: hsheha@northwell.edu.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Tello', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York.'}, {'ForeName': 'Lama A', 'Initials': 'LA', 'LastName': 'Al-Aswad', 'Affiliation': 'Harkness Eye Institute, Columbia University, New York, New York.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Sayed', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: rlee@med.miami.edu.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.08.003']
1264,32676780,"Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial.","PURPOSE


This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.
METHODS


The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.
RESULTS


A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.
CONCLUSION


The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION


ChiCTR-1800016430 2018-06-01.",2020,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","['Patients with an Autar score\u2009>\u200910', '599 patients from eight hospitals participated in this clinical trial', 'Patients with an Autar score\u2009≤\u200910', 'patients with high-risk thrombosis', 'patients with stenosis or spondylolisthesis using the combination of']","['tranexamic acid and rivaroxaban', 'TXA', 'posterior lumbar interbody fusion (PLIF', 'tranexamic acid (TXA) and rivaroxaban', '10-mg rivaroxaban', 'rivaroxaban', 'TXA via intravenous injection and 1\xa0g TXA', 'placebo']","['VTE incidence rates', 'blood loss and preventing venous thromboembolism (VTE', 'blood transfusion rate', 'Epidural haematoma', 'probability of thrombosis', 'blood loss and transfusion rates', 'total blood loss, intra-operative blood loss, and drainage volume', 'blood loss and the transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",599.0,0.107914,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China.'}, {'ForeName': 'Tingjin', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': ""Department of Spine Surgery, Dezhou People's Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China.'}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Jiao', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Haichun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Chunyang', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Zhaozhong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Yunzhen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. qilucyz@yeah.net.'}]",International orthopaedics,['10.1007/s00264-020-04699-3']
1265,33066130,"Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.","Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y ( n  = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.",2020,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).",['online panel of adults age '],"['control label (barcode), an octagon warning, a circle warning, and a triangle warning']",['message effectiveness'],"[{'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0350172,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).","[{'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, Lineberger Comprehensive Cancer Center, Carolina Population Center, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Gómez', 'Affiliation': 'Facultad de Medicina, Pontificia Universidad Javeriana, 110231 Bogotá, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Murukutla', 'Affiliation': 'Vital Strategies, New York, NY 27599, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Mora-Plazas', 'Affiliation': 'Departamento de Nutrición Humana, Universidad Nacional de Colombia, 11001 Bogotá, Colombia.'}]",Nutrients,['10.3390/nu12103124']
1266,33066213,Oxygenation before Endoscopic Sedation Reduces the Hypoxic Event during Endoscopy in Elderly Patients: A Randomized Controlled Trial.,"BACKGROUND


Sedation endoscopy increases patient and examiner satisfaction but involves complications. The most serious complication is hypoxia, the risk factors for which are old age, obesity, and American Society of Anesthesiologists physical status of 3 or greater. However, clear evidence of oxygenation during sedation endoscopy for elderly people is lacking in US, European, and Korean guidelines.
METHOD


This study was conducted for 1 year starting in August 2018 to evaluate whether pre-oxygenation use 1 min before sedation endoscopy could reduce the incidence of hypoxia in patients older than 65 years of age. A total of 70 patients were divided into the non-oxygenated group ( n  = 35; control group) and oxygen-treated group ( n  = 35; experimental group) during endoscopy.
RESULT


The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group. Factors related to hypoxia in the non-oxygenated group were a relatively high dose of midazolam and concomitant injection with narcotic analgesics such as pethidine.
CONCLUSION


The incidence of hypoxia during sedation endoscopy is high in patients over 65 years, but oxygenation during endoscopic sedation in elderly people can significantly reduce the incidence of intraprocedural hypoxic events.",2020,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"['70 patients', 'Elderly Patients', 'patients older than 65 years of age']","['oxygen-treated group ( n  = 35; experimental group) during endoscopy', 'pre-oxygenation use 1 min before sedation endoscopy', 'midazolam']",['incidence of hypoxia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",70.0,0.0672732,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"[{'ForeName': 'Hyunil', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Jeong Nam', 'Initials': 'JN', 'LastName': 'Hyun', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Kyong Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hong Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103282']
1267,33066237,"Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial.","Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution (control group,  n  = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more ""average"" scores (95% vs. 44%,  p <  0.001) and were more willing to use the same agents again (90.26% vs. 61.85%,  p <  0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.",2020,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","['patients who show a poor compliance with conventional bowel preparation agents', '385 volunteers', 'Bowel Preparation', 'healthy patients']","['Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution', '2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution', 'probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution']","['patient tolerability', 'nausea, vomiting, and abdominal bloating events', 'Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles', 'efficacy, safety, and patient tolerability profiles', 'polyp and adenoma detection rates', 'average"" scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",385.0,0.0465274,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","[{'ForeName': 'Youn I', 'Initials': 'YI', 'LastName': 'Choi', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jong-Joon', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Dong Kyun', 'Initials': 'DK', 'LastName': 'Park', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kwang An', 'Initials': 'KA', 'LastName': 'Kwon', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103286']
1268,33066334,"A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO ® ) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study).","Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was -32.5 ± 30.2 mg/dL (-19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of -39.2 mg/dL (95% CI: -48.6; -29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical ( p  < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.",2020,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","['mildly hypercholesterolemic patients', 'Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study', '88 moderately hypercholesterolemic subjects']","['Nutraceutical Combination (LEVELIP DUO ® ', 'combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo', 'combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo', 'placebo', 'Placebo']","['plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios', 'Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C', 'lipid profile', 'Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C', 'mean LDL-Cholesterol (LDL-C) change', 'LDL Cholesterol Levels and Lipid Pattern']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}, {'cui': 'C0997449', 'cui_str': 'Monascus purpureus'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",88.0,0.389198,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': ""D'Addato"", 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12103127']
1269,33067692,Scalp Topography of Lower Urinary Tract Sensory Evoked Potentials.,"Impaired lower urinary tract (LUT) afferents often cause LUT symptoms. Assessment of LUT afferent pathways is possible using bipolar cortical sensory evoked potential (SEP) recordings with the active electrode at the vertex during electrical stimulation in the LUT. This study aimed to investigate the topographical distribution and microstates of lower urinary tract sensory evoked potentials (LUTSEPs) using different stimulation frequencies. Ninety healthy subjects (18-36 years old, 40 women) were randomly assigned to one of five stimulation locations [bladder dome; trigone; proximal, membranous (men only) or distal urethra]. Cycles of 0.5 Hz/1.1 Hz/1.6 Hz electrical stimulation were applied using a custom-made catheter. Cortical activity was recorded from 64 surface electrodes. Marker setting was performed manually on an individual subject-level for the P1, N1, and P2 components of vertex recordings. N1 and P2 topographies presented with central negativities and positivities around the vertex. Regarding topographical distribution, Randomization Graphical User interface (RAGU) analyses revealed consistent frequency effects and microstates for N1/P2. Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2. LUTSEP topographies suggest central generators in the somatosensory cortex, which are not detectable in a bipolar set-up. The observed frequency effect indicates fiber refractoriness at higher frequencies. The multichannel approach allows more comprehensive assessment of LUTSEPs and might therefore be sensitive to pathological changes. Examinations in patients with LUT symptoms are needed to further investigate this biomarker.",2020,"Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2.","['patients with LUT symptoms', 'Ninety healthy subjects (18-36\xa0years old, 40 women']","['Hz electrical stimulation', 'five stimulation locations [bladder dome; trigone; proximal, membranous (men only) or distal urethra']","['map strength for P1, N1, and P2', 'Cortical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0444914', 'cui_str': 'Domed'}, {'cui': 'C0447586', 'cui_str': 'Trigonal structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}]","[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",90.0,0.0382707,"Higher stimulation frequencies resulted in decreasing map strength for P1, N1, and P2.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008, Zürich, Switzerland. martina.liechti@balgrist.ch.'}]",Brain topography,['10.1007/s10548-020-00796-z']
1270,33068425,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18), and for twice-weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19-compatible illness (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"['healthcare workers', 'healthcare workers at high risk of exposure', 'Participants across the United States and in the Canadian province of Manitoba', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures', 'healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Covid-19-compatible illness', 'probable Covid-19-compatible illness', 'Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.743112,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1571']
1271,33073622,A Prospective and Retrospective Clinical Controlled Observation of Chinese Herbal Decoction (SMLJ01) for Type 1 Gastric Neuroendocrine Tumors.,"INTRODUCTION


Type 1 gastric neuroendocrine tumors (g-NETs) have a good prognosis but a high recurrence rate.
AIM


To observe the clinical efficacy of the treatment of type 1 g-NETs with the Chinese herbal decoction SMLJ01.
MATERIALS AND METHODS


A prospective and retrospective, clinical, controlled observation was conducted in 4 Chinese centers from 2012 to 2019. Patients with type 1 g-NETs were nonrandomly divided into treatment and control groups after endoscopic treatment based on herbal treatment administered according to their wishes. The treatment group received oral SMLJ01, with follow-up every 6 to 12 months, while the control group received follow-up alone. Patient follow-up (via telephone) from 2012 to 2017 was mainly retrospective. All patients after 2017 were followed prospectively. The recurrence times and rates were compared after treatment for at least 6 months. Symptom improvements were evaluated in the treatment group. The follow-up ended on October 31, 2019.
RESULTS


During a median follow-up of 22 months (range: 2-86 months), the survival rate was 100%, and no metastases occurred. Twenty-one of the 82 treated patients (25.6%) had recurrence after a median of 22 months, and 22 of the 54 control patients (40.7%) had recurrence after a median of 8 months ( P  = .063). The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001). The risk of recurrence in the treatment group was 0.38 relative to that in the control group (95% CI: 0.20-0.70). The symptom score of the patients after taking Chinese medicine was 19.5 (10.3, 28.0), which was significantly lower than before treatment (31.5 (19.3, 38.0)). The difference was statistically significant ( P  < .01).
CONCLUSION


SMLJ01, with the effects of soothing the liver, strengthening the spleen, increasing acid and harmonizing the stomach, may help reduce the recurrence rate, relieve symptoms and prolong the recurrence time in patients with type 1 g-NETs and is worthy of evaluation with further randomized research with large sample sizes and longer follow-up periods.",2020,The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001).,"['4 Chinese centers from 2012 to 2019', 'Patients with type 1 g-NETs', 'Type 1 Gastric Neuroendocrine Tumors', 'All patients after 2017 were followed prospectively']","['Chinese herbal decoction SMLJ01', 'oral SMLJ01', 'Chinese Herbal Decoction (SMLJ01']","['Symptom improvements', 'risk of recurrence', 'recurrence times and rates', 'symptom score', 'recurrence', 'median recurrence-free survival (RFS) time', 'survival rate']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919551', 'cui_str': 'Duration of recurrence-free survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0340016,The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001).,"[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Deng', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jiqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University; National Clinical Research Center for Digestive Diseases; Beijing Digestive Disease Center; Beijing Key Laboratory for Precancerous Lesion of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Dou', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinran', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jixi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Huangying', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420958488']
1272,33069301,"Cytisine for smoking cessation in patients with tuberculosis: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.","BACKGROUND


Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan.
METHODS


We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete.
FINDINGS


Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI -0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication.
INTERPRETATION


Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
FUNDING


European Union Horizon 2020 and Health Data Research UK.
TRANSLATIONS


For the Bengali and Urdu translations of the abstract see Supplementary Materials section.",2020,"Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
","['53', 'patients with tuberculosis', 'Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan', 'Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking', '32 health centres in Bangladesh and Pakistan', 'patients with tuberculosis in Bangladesh and Pakistan']","['cystine', 'behavioural support plus either oral cytisine', 'placebo', 'Cytisine', 'cytisine']","['continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date', 'continuous abstinence', 'serious adverse events', 'breath carbon monoxide reading']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C2984220', 'cui_str': 'Bidis Tobacco'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0071109', 'cui_str': ""piperazine-N,N'-bis(2-ethanesulfonic acid)""}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",2472.0,0.753733,"Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
","[{'ForeName': 'Omara', 'Initials': 'O', 'LastName': 'Dogar', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Usher Institute, University of Edinburgh, Edinburgh, UK. Electronic address: omara.dogar@york.ac.uk.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Marshall', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Huque', 'Affiliation': 'ARK Foundation, Dhaka, Bangladesh; Department of Economics, University of Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Barua', 'Affiliation': 'ARK Foundation, Dhaka, Bangladesh.'}, {'ForeName': 'Razia', 'Initials': 'R', 'LastName': 'Fatima', 'Affiliation': 'Common Management Unit (TB, HIV/AIDS and Malaria), Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The Initiative, Islamabad, Pakistan.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Zahid', 'Affiliation': 'The Initiative, Islamabad, Pakistan.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mansoor', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK; Addiction Research and Clinical Epidemiology Unit, Institute of General Practice, Centre for Health and Society, Heinrich-Heine-University, Düsseldorf, Germany; Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Boeckmann', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Addiction Research and Clinical Epidemiology Unit, Institute of General Practice, Centre for Health and Society, Heinrich-Heine-University, Düsseldorf, Germany; Department of Environment and Health, School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Elsey', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kralikova', 'Affiliation': '3rd Medical Department, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic; Institute of Hygiene and Epidemiology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Readshaw', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Hull York Medical School, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30312-0']
1273,33069302,"Patterns of individual non-treatment during multiple rounds of mass drug administration for control of soil-transmitted helminths in the TUMIKIA trial, Kenya: a secondary longitudinal analysis.","BACKGROUND


Few studies have been done of patterns of treatment during mass drug administration (MDA) to control neglected tropical diseases. We used routinely collected individual-level treatment records that had been collated for the Tuangamize Minyoo Kenya Imarisha Afya (Swahili for Eradicate Worms in Kenya for Better Health [TUMIKIA]) trial, done in coastal Kenya from 2015 to 2017. In this analysis we estimate the extent of and factors associated with the same individuals not being treated over multiple rounds of MDA, which we term systematic non-treatment.
METHODS


We linked the baseline population of the TUMIKIA trial randomly assigned to receive biannual community-wide MDA for soil-transmitted helminthiasis to longitudinal records on receipt of treatment in any of the four treatment rounds of the study. We fitted logistic regression models to estimate the association of non-treatment in a given round with non-treatment in the previous round, controlling for identified predictors of non-treatment. We also used multinomial logistic regression to identify factors associated with part or no treatment versus complete treatment.
FINDINGS


36 327 participants were included in our analysis: 16 236 children aged 2-14 years and 20 091 adults aged 15 years or older. The odds of having no treatment recorded was higher if a participant was not treated during the previous round of MDA (adjusted odds ratio [OR] 3·60, 95% CI 3·08-4·20 for children and 5·58, 5·01-6·21 for adults). For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household. Women had higher odds than men of receiving part or no treatment. However, when those with pregnancy or childbirth in the previous 2 weeks were excluded, women became more likely to receive complete treatment. Adults aged 20-25 years were the age group with the highest odds of receiving part (OR 1·41, 95% CI 1·22-1·63) or no treatment (OR 1·81, 95% CI 1·53-2·14).
INTERPRETATION


Non-treatment was associated with specific sociodemographic groups and characteristics and did not occcur at random. This finding has important implications for MDA programme effectiveness, the relevance of which will intensify as disease prevalence decreases and infections become increasingly clustered.
FUNDING


Bill & Melinda Gates Foundation, Joint Global Health Trials Scheme of the Medical Research Council, UK Department for International Development, Wellcome Trust, Children's Investment Fund Foundation, and London Centre for Neglected Tropical Diseases.",2020,"For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household.","['327 participants were included in our analysis: 16\u2008236 children aged 2-14 years and 20\u2008091 adults aged 15 years or older', '36', 'Adults aged 20-25 years were the age group with the highest odds of receiving part (OR 1·41, 95% CI 1·22-1·63) or no treatment (OR 1·81, 95% CI 1·53-2·14', 'routinely collected individual-level treatment records that had been collated for the Tuangamize Minyoo Kenya Imarisha Afya (Swahili for Eradicate Worms in Kenya for Better Health [TUMIKIA]) trial, done in coastal Kenya from 2015 to 2017', 'Women had higher odds than men of receiving part or no treatment']",['biannual community-wide MDA'],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]",[],36327.0,0.0564094,"For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Oswald', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: william.oswald@lshtm.ac.uk.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Kepha', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya; Pwani University Bioscience Research Centre, Pwani University, Kilifi, Kenya.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Halliday', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mcharo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': ""Th'uva"", 'Initials': 'T', 'LastName': 'Safari', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Witek-McManus', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hardwick', 'Affiliation': ""London Centre for Neglected Tropical Disease Research, Faculty of Medicine, Department of Infectious Disease Epidemiology, School of Public Health, St Mary's Campus, Imperial College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sultani H', 'Initials': 'SH', 'LastName': 'Matendechero', 'Affiliation': 'Neglected Tropical Diseases Unit, Division of Communicable Disease Prevention and Control, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Brooker', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Mwandawiro', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Anderson', 'Affiliation': ""London Centre for Neglected Tropical Disease Research, Faculty of Medicine, Department of Infectious Disease Epidemiology, School of Public Health, St Mary's Campus, Imperial College London, London, UK.""}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Pullan', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30344-2']
1274,33070770,Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial.,"BACKGROUND


Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious.
OBJECTIVE


We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial.
METHODS


140 women with a multifetal pregnancy at less than 28 weeks' gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1.
RESULTS


The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups.
CONCLUSION


Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.",2020,"The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones.","['premature infants', 'multifetal pregnancies', ""140 women with a multifetal pregnancy at less than 28 weeks' gestational age"", 'Neonatal Respiratory Distress Syndrome (NRDS', 'Multifetal Pregnancies']","['betamethasone therapy', 'Betamethasone', 'intramuscularly betamethasone', 'betamethasone']","['incidence of NRDS', 'neonatal ventilation', 'chance of NRDS', 'age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",140.0,0.138976,"The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abbasalizadeh', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Pouya', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Zakeri', 'Affiliation': 'Department of Health Services Management, School of Management and Medical Informatics, Iranian International Safe Community Support Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Asgari-Arbat', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Abbasalizadeh', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Parnianfard', 'Affiliation': 'Research Center for Evidence-Based Medicine, Drug Applied Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666191007154936']
1275,33070796,Effect of acute citalopram on self-referential emotional processing and social cognition in healthy volunteers.,"BACKGROUND


Depression is characterised by negative views of the self. Antidepressant treatment may remediate negative self-schema through increasing processing of positive information about the self. Changes in affective processing during social interactions may increase expression of prosocial behaviours, improving interpersonal communications.
AIMS


To examine whether acute administration of citalopram is associated with an increase in positive affective learning biases about the self and prosocial behaviour.
METHOD


Healthy volunteers (n = 41) were randomised to either an acute 20 mg dose of citalopram or matched placebo in a between-subjects double-blind design. Participants completed computer-based cognitive tasks designed to measure referential affective processing, social cognition and expression of prosocial behaviours.
RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%). Exploratory analyses indicated that participants administered citalopram showed a positive bias when learning social evaluations about a friend (β = 4.06, 95% CI: 0.88, 7.24), but not about the self or a stranger. Similarly, exploratory analyses found evidence of increased recall of positive words and reduced recall of negative words about others (β = 2.41, 95% CI: 0.89, 3.93), but not the self, in the citalopram group.
CONCLUSIONS


Participants administered citalopram showed greater prosocial behaviours, increased positive recall and increased positive learning of social evaluations towards others. The increase in positive affective bias and prosocial behaviours towards others may, at least partially, be a mechanism of antidepressant effect. However, we found no evidence that citalopram influenced self-referential processing.",2020,"RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%).","['healthy volunteers', 'Healthy volunteers (n = 41']","['acute citalopram', 'citalopram', 'placebo', 'acute 20 mg dose of citalopram or matched placebo']","['learning social evaluations', 'positive affective bias and prosocial behaviours', 'positive recall and increased positive learning of social evaluations', 'self-referential emotional processing and social cognition', 'positive affective learning biases', 'cooperative choices', 'recall of positive words and reduced recall of negative words', 'self-referential processing', 'prosocial behaviours', 'referential affective processing, social cognition and expression of prosocial behaviours']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",41.0,0.184854,"RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hobbs', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carson', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Indra Van', 'Initials': 'IV', 'LastName': 'Assche', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Mayowa', 'Initials': 'M', 'LastName': 'Oyesanya', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sui', 'Affiliation': 'School of Psychology, University of Aberdeen, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Psychological Science, University of Bristol, MRC Integrative Epidemiology Unit at the University of Bristol, and National Institute of Health Research Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Population Health Sciences, University of Bristol.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Button', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}]",BJPsych open,['10.1192/bjo.2020.107']
1276,33076387,Effects of Yangsaeng (Health Management) Therapy for Korean Older Adults in Nursing Home.,"The number of older adults admitted to nursing homes is steadily increasing, and the health management for them is a very important issue in Korean society. This study aimed to examine the effects of Yangsaeng (health management) therapy on physical health status, depression, life satisfaction, and Yangsaeng (health management) of Korean older adults in nursing homes. A quasi-experimental study design using a pretest-posttest control group was employed. Study participants were a total of 80 older adults (intervention: n = 40, control: n = 40) in a nursing home in Seoul, South Korea. Yangsaeng therapy as an intervention consisted of the Meridian therapy and Qi-gong therapy. Yangsaeng therapy was conducted for 50 min per one time, twice a week, and for 10 weeks. Measures were general characteristics of study participants, Cornell Medical Index, Geriatric Depression Scale, life satisfaction scale, and Yangsaeng scale. Data were collected from April 2018 to March 2019. There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups. Yangsaeng therapy was an effective intervention for improving physical health status, life satisfaction, and Yangsaeng, and for decreasing depression of older adults in nursing homes. Health care providers need to pay attention to Yangsaeng therapy as a Korean traditional intervention method for the health management of the older adults residing in nursing homes.",2020,"There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups.","['Study participants were a total of 80 older adults (intervention: n = 40, control: n = 40) in a nursing home in Seoul, South Korea', 'older adults in nursing homes', 'Korean older adults in nursing homes', 'Korean Older Adults in Nursing Home', 'older adults residing in nursing homes', 'older adults admitted to nursing homes']","['Yangsaeng (health management) therapy', 'Yangsaeng (Health Management) Therapy', 'Yangsaeng therapy', 'Meridian therapy and Qi-gong therapy']","['Cornell Medical Index, Geriatric Depression Scale, life satisfaction scale, and Yangsaeng scale', 'physical health status, depression, life satisfaction, and Yangsaeng (health management', 'physical health status, life satisfaction, and Yangsaeng', 'physical health status, depression, life satisfaction, and Yangsaeng']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1658399', 'cui_str': 'Admission to nursing home'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}]","[{'cui': 'C0010045', 'cui_str': 'Cornell Medical Index'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",80.0,0.0188631,"There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups.","[{'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Se Yun', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Graduate School, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Da Un', 'Initials': 'DU', 'LastName': 'Jung', 'Affiliation': 'Department of Nursing, Graduate School, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Youngmi', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Choonhae College of Health Sciences, Ulsan 44610, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207507']
1277,33076411,Winter Exercise and Speleotherapy for Allergy and Asthma: A Randomized Controlled Clinical Trial.,"(1) Background: The prevalence of allergic respiratory diseases is still rising and efforts towards holistic treatments should be made. Although speleotherapy is widely applied in Europe to treat chronic airway diseases, the existing scientific evidence is rather low. Recreational winter exercise has been shown to improve allergic airway inflammation, but little is known about the combined effects of speleotherapy and recreational winter exercise. (2) Methods: In this clinical study we investigated the effects of winter exercise and speleotherapy on adults with allergic rhinitis and/or asthma. The speleotherapy group (n = 23) participated in a ten-day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program. The effects on allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness were assessed. (3) Results: No significant effects were found for fractional exhaled nitric oxide or nasal nitric oxide. Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group. (4) Conclusions: Winter exercise alone and winter exercise in combination with speleotherapy improve quality of life and allergic symptoms in adults with allergic rhinitis and/or asthma. Further studies are required to investigate the specific effects of speleotherapy. To our knowledge, this is the first investigation examining speleotherapy in combination with winter exercise. Recreational outdoor winter exercise and speleotherapy may be recommended for highly functioning patients with good disease control.",2020,Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"['adults with allergic rhinitis and/or asthma', 'group (n = 23) participated in a ten', 'highly functioning patients with good disease control', 'Allergy and Asthma']","['Winter exercise alone and winter exercise in combination with speleotherapy', 'Winter Exercise and Speleotherapy', 'winter exercise and speleotherapy', 'Recreational outdoor winter exercise and speleotherapy', 'Recreational winter exercise', 'day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program', 'speleotherapy']","['fractional exhaled nitric oxide or nasal nitric oxide', 'allergic symptoms', 'Quality of life', 'allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness', 'quality of life and allergic symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339510', 'cui_str': 'Vitelliform dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2350293', 'cui_str': 'Speleotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",23.0,0.0253318,Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freidl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Huber', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Braunschmid', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Romodow', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pichler', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Weisböck-Erdheim', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Hartl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9103311']
1278,32674613,Immediate effect of neuromuscular electrical stimulation on the abductor hallucis muscle: A randomized controlled trial.,"Hallux valgus (HV) is a foot deformity with deviation of the greater toe and the first metatarsal. There is little evidence on training the abductor hallucis muscle (AbdH) to treat HV because of the difficulty in implementing the necessary interventions. Although neuromuscular electrical stimulation (NMES) has been used to induce voluntary exercise, there is currently no study on NMES for AbdH. We aimed to verify the immediate effect of NMES on the AbdH muscle function. For the NMES group (n = 15), electrical stimulation was applied for 20 min. In the sham group (n = 15), the stimulating device was set but not turned on. Electromyogram, HV angle (HVA) at rest and during abduction of the big toe, and strength of the AbdH were evaluated. Analysis of covariance was used to investigate differences within groups using the baseline as the covariate. NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  p  = .00, HVA exercise:  p  = .00, AbdH strength:  p  = .00). HVA at rest showed no change ( p  = .12). Application of NMES on the AbdH muscle immediately improved its activity output, muscle strength, and HVA during exercise.",2020,"NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  ",['abductor hallucis muscle'],"['NMES', 'neuromuscular electrical stimulation (NMES', 'HVA exercise', 'neuromuscular electrical stimulation']","['activity output, muscle strength, and HVA', 'maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC', 'Electromyogram, HV angle (HVA) at rest and during abduction of the big toe, and strength of the AbdH']","[{'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}]",,0.0262283,"NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  ","[{'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Shimoura', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Abiko', 'Affiliation': 'Science Department, Ito Co., Ltd ., Saitama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Zeidan', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kajiwara', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Bito', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Soyoka', 'Initials': 'S', 'LastName': 'Yoshimi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Kawabe', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1793166']
1279,32674155,"Corrigendum to: ""Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study"" by Russo et al. Neurosurgery, 2020, nyaa003, https://doi.org/10.1093/neuros/nyaa003.",,2020,,[],['Closed-Loop Spinal Cord Stimulation'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]",[],,0.0133076,,[],Neurosurgery,['10.1093/neuros/nyaa332']
1280,33065990,Socio-Demographic Characteristics and Body Weight Perceptions of Study Participants Benefitting Most from the Feel4Diabetes Program Based on Their Anthropometric and Glycaemic Profile Changes.,"The Feel4Diabetes program was comprised of a community-based screening and a two-year intervention phase aiming to prevent type 2 diabetes (T2D) in families at risk for diabetes across Europe. The current work aimed to identify the socio-demographic characteristics and body weight perceptions of participants who benefitted the most, achieving at least a 5% reduction in body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels), over two-year period. Following a two-stage screening procedure, 2294 high-risk parents were randomly allocated to standard care or more intensive intervention. The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05). Furthermore, individuals with tertiary education (OR 2.06,  p  < 0.001), who were unemployed (OR 1.62-1.68,  p  < 0.05) and perceived their body weight to be higher than normal (OR 1.58-3.00,  p  < 0.05) were more likely to benefit from the program. Lastly, males were more likely to show improvements in their glycaemic profiles compared to females (OR 1.40,  p  = 0.024). These findings point out the regions in Europe and the sociodemographic profile of individuals that benefitted the most in the current study, highlighting the need to prioritise regions in greater need for such interventions and also tailor future interventions to the characteristics and perceptions of the target populations.",2020,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).",['2294 high-risk parents'],"['standard care or more intensive intervention', 'Feel4Diabetes Program']","['glycaemic profiles', 'body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels', 'body weight', 'Socio-Demographic Characteristics and Body Weight Perceptions']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",2294.0,0.0350729,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Karatzi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Apergi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Alelí M', 'Initials': 'AM', 'LastName': 'Ayala-Marín', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Kaloyan', 'Initials': 'K', 'LastName': 'Tsochev', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Chakarova', 'Affiliation': 'Clinical Center of Endocrinology, Department of Diabetology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Antal', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, 9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindstrom', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103117']
1281,33066009,Choline Intake as Supplement or as a Component of Eggs Increases Plasma Choline and Reduces Interleukin-6 without Modifying Plasma Cholesterol in Participants with Metabolic Syndrome.,"Metabolic syndrome (MetS) is characterized by low-grade inflammation and insulin resistance, which increase the risk of heart disease. Eggs have numerous nutrients including choline, carotenoids, and fat-soluble vitamins that may protect against these conditions. Egg phosphatidylcholine (PC) is a major contributor of dietary choline in the American diet. However, uncertainty remains regarding eggs due to their high concentration of cholesterol. In this study, we evaluated the effect of two sources of choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB), on plasma lipids, glucose, insulin resistance, and inflammatory biomarkers. We recruited 23 subjects with MetS to participate in this randomized cross-over intervention. After a 2-week washout, with no choline intake, participants were randomly allocated to consume three eggs/day or CB (~400 mg choline/d for both) for 4 weeks. After a 3-week washout period, they were allocated to the alternate treatment. Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01). Interestingly, there were no changes in plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose, compared either to baseline or between treatments. In contrast, interleukin-6 was reduced, with both sources of choline compared to baseline, while eggs also had an effect on lowering C-reactive protein, insulin, and insulin resistance compared to baseline. This study demonstrates that in a MetS population, intake of three eggs per day does not increase plasma LDL cholesterol, and has additional benefits on biomarkers of disease compared to a choline supplement, possibly due to the presence of other antioxidants in eggs.",2020,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"['Participants with Metabolic Syndrome', '23 subjects with MetS to participate in this randomized cross-over intervention']","['Egg phosphatidylcholine (PC', 'CB', 'choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB']","['concentrations of vitamin E and selenium', 'Metabolic syndrome (MetS', 'lowering C-reactive protein, insulin, and insulin resistance', 'plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose', 'plasma lipids, glucose, insulin resistance, and inflammatory biomarkers', 'plasma LDL cholesterol']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008408', 'cui_str': 'Choline bitartrate'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",23.0,0.0838643,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'DiBella', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Minu S', 'Initials': 'MS', 'LastName': 'Thomas', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Alyousef', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Millar', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blesso', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12103120']
1282,33066040,Effect of a Nutritional Support System (Diet and Supplements) for Improving Gross Motor Function in Cerebral Palsy: An Exploratory Randomized Controlled Clinical Trial.,"BACKGROUND


Most patients with cerebral palsy (CP) do not respond to physical therapy due to deterioration in their nutritional status, secondary to gastrointestinal disorders and the catabolic state of the disease itself. However, basic treatments only contemplate the energy requirements and do not consider supplementation with glutamine, zinc, selenium, colecalciferol, spirulina, omega 3 or even vegetal proteins.
OBJECTIVE


In this study, we determined the effect of using a nutritional support system (NSS): diet and supplements, on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).
METHODS


An exploratory study was performed. Thirty patients (from 4 to 12 years old) were randomly assigned to: (1) dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG). Gross motor function was evaluated using the gross motor function measure (GMFM) scale.
RESULTS


The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups. Fifty percent of the IG-treated patients managed to walk, while in the other groups, no patients were able to walk.
CONCLUSIONS


The NSS used in the present work improves gross motor function and promotes walking in patients with CP.",2020,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"['patients with cerebral palsy (CP', 'Thirty patients (from 4 to 12 years old', 'Cerebral Palsy', 'children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III', 'patients with CP']","['Nutritional Support System (Diet and Supplements', 'dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG', 'nutritional support system (NSS): diet and supplements']","['standing and walking parameters', 'gross motor function measure (GMFM) scale', 'Gross motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.017051,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leal-Martínez', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Franco', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Peña-Ruiz', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Castro-Silva', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Escudero-Espinosa', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Rolón-Lacarrier', 'Affiliation': 'Departamento de Investigación y Enseñanza, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría CMN siglo XXI, Ciudad de Mexico 06720, Mexico.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'De León', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Linares-Eslava', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101449']
1283,33069163,Mid-pregnancy weight gain is associated with offspring adiposity outcomes in early childhood.,"BACKGROUND


Gestational weight gain (GWG) has been linked to childhood obesity. However, it is unclear if the timing of weight gain influences offspring body composition. A secondary analysis of a clinical trial examined the influence of total, early, and mid-pregnancy GWG on adiposity outcomes in 186 children at birth, 1, 3, and 5 years.
METHODS


Early (<15 weeks) and mid-pregnancy GWG (15-32 weeks) were assessed. Anthropometrics and abdominal ultrasound were measured annually in children from birth to 5 years. MRI was performed in a sub-group of 44 children at 5 years to estimate abdominal fat.
RESULTS


Almost half of the women (n = 86/186) gained excess weight in pregnancy, and women with a BMI ≥ 25 kg/m 2  (n = 33) were more likely to gain in excess. Mid-pregnancy GWG predicted higher weight (g) and subcutaneous fat by ultrasound (mm 2 ) and MRI (cm 3 ) at 5 years [β: 139.34 g (95% CI: -0.22; 278.90), p = 0.050; β: 1.42 mm 2  (95% CI: 0.06; 2.78), p = 0.041; and β: 18.56 cm 3  (95% CI: 1.30; 35.82) p = 0.036, respectively].
CONCLUSIONS


Mid-pregnancy weight gain was associated with greater fat depots at 5 years, which suggests that the timing of GWG has differential effects on offspring adiposity outcomes.
IMPACT


Gestational weight gained in mid-pregnancy is associated with growth and adipose tissue development at 5 years. We observed that maternal weight gain in early and mid-gestation has differential effects on offspring body composition. Mid-pregnancy weight gain (15-32 weeks gestation) appears to influence child growth and abdominal fat accretion which may have implications for long-term metabolic health. Interventions that prevent excessive gestational weight gain in mid-pregnancy may affect obesity risk in early childhood. Prenatal care should stress the importance of optimal weight gain throughout pregnancy.",2020,pregnancy GWG predicted higher weight (g) and subcutaneous fat (mm 2 ) by ultrasound and MRI (cm 3 ) at 5 years [β:,"['Early (<15 weeks) and mid-pregnancy GWG (15-32 weeks', '186 children at birth, 1, 3, and 5 years', '25', 'children from birth to 5 years']",[],"['Anthropometrics and abdominal ultrasound', 'gain in excess. Mid', 'excessive gestational weight gain', 'weight (g) and subcutaneous fat', 'Gestational weight', 'maternal weight gain']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",[],"[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]",186.0,0.0947749,pregnancy GWG predicted higher weight (g) and subcutaneous fat (mm 2 ) by ultrasound and MRI (cm 3 ) at 5 years [β:,"[{'ForeName': 'Dorothy Marie', 'Initials': 'DM', 'LastName': 'Meyer', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Stecher', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brei', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hauner', 'Affiliation': 'Else Kröner-Fresenius-Centre for Nutritional Medicine, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Georg-Brauchle-Ring 62, 80992, Munich, Germany. hans.hauner@tum.de.'}]",Pediatric research,['10.1038/s41390-020-01202-x']
1284,33072352,The effectiveness of telegram-based virtual education versus in-person education on the quality of life in adolescents with moderate-to-severe asthma: A pilot randomized controlled trial.,"Aim


In recent years, mobile applications have been developed for health education purposes. The aim of this study was to determine whether Telegram-based virtual education versus in-person education can be effective for improving the quality of life in adolescents with moderate-to-severe asthma.
Design


A single-blind randomized trial.
Methods


Participants were 64 adolescents aged 12-19 years and were equally assigned randomly to group A (Telegram-based education) and group B (in-person education) during 22 June 2017-19 February 2018. The educational contents were similar for both groups. The Mini Pediatric Asthma Quality of Life Questionnaire was used prior to intervention and 5 weeks postintervention for both groups of adolescents.
Results


A statistically significant increase was observed in the quality of life in both groups ( p  < .001). After controlling the quality-of-life scores, there was no statistically significant difference between the groups in terms of the mean score for the quality of life and its domains ( p  < .05).",2020,A statistically significant increase was observed in the quality of life in both groups ( p  < .001).,"['64 adolescents aged 12-19\xa0years', 'adolescents with moderate-to-severe asthma']","['telegram-based virtual education versus in-person education', 'Telegram-based virtual education versus in-person education']","['quality-of-life scores', 'quality of life', 'mean score for the quality of life and its domains', 'Mini Pediatric Asthma Quality of Life Questionnaire']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0952909,A statistically significant increase was observed in the quality of life in both groups ( p  < .001).,"[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faraji', 'Affiliation': 'Department of Pediatric Nursing School of Nursing and Midwifery Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Iranian Center for Evidence-Based Practice, Nursing and Midwifery School Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Sharifi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Shabazi', 'Affiliation': 'Department of Medical-Surgical Nursing, Nursing and Midwifery School Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghojazadeh', 'Affiliation': 'Iranian Center for Evidence-Based Practice, Medicine School Tabriz University of Medical Sciences Tabriz Iran.'}]",Nursing open,['10.1002/nop2.552']
1285,33074110,Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.,"AIM


to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- β - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.",2020,KBP & PLB did not decrease RPE as compared to AVP & DBE,['60\xa0at'],"['Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked', 'AVP & DBE']","['RPE', 'anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE', 'RPE change', 'DBE increased BHT']",[],"[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0686435,KBP & PLB did not decrease RPE as compared to AVP & DBE,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'AP-III, AIPT, 9711113097, India. Electronic address: mailmayankshukla@gmail.com.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'BPT Interns, AIPT, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'BPT Interns, AIPT, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101248']
1286,33074143,Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder.,"BACKGROUND


The glutamatergic modulator ketamine rapidly reduces depressive symptoms in individuals with treatment-resistant major depressive disorder (MDD). However, ketamine's effects on emotional processing biases remain largely unknown, and understanding these processes may help elucidate ketamine's mechanism of action.
METHODS


Magnetoencephalography (MEG) was used to investigate ketamine's effects on early visual responses to affective stimuli in individuals with MDD (n=31) and healthy volunteers (HVs; n=24). Participants were enrolled in a double-blind, placebo-controlled, crossover clinical trial and were assessed at baseline and after subanesthetic-dose ketamine and placebo-saline infusions. During MEG recording, participants completed an emotional evaluation task in which they indicated the sex or emotional valence (happy-neutral or sad-angry) of facial stimuli. Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies were extracted from regions of interest. Linear fixed effects models examined interactions between diagnosis, stimulus valence, and drug session for behavioral and MEG data.
RESULTS


In baseline behavioral analyses, MDD participants exhibited higher accuracy for sad-angry than happy-neutral faces, and HVs responded faster to happy-neutral than sad-angry faces. In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine. Finally, fusiform M170 amplitudes were associated with antidepressant response in MDD participants.
LIMITATIONS


The modest sample size and the need to collapse across responses to happy and neutral faces to increase statistical power limit the generalizability of the findings.
CONCLUSIONS


Ketamine rapidly altered emotional stimulus processing in MDD, laying the groundwork for future investigations of biomarkers of antidepressant treatment response.
CLINICAL TRIAL


Clinicaltrials.gov, NCT#00088699.",2020,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","['individuals with MDD (n=31) and healthy volunteers (HVs; n=24', 'Major Depressive Disorder', 'individuals with treatment-resistant major depressive disorder (MDD']","[""ketamine's"", 'Ketamine', 'glutamatergic modulator ketamine', 'ketamine', 'Magnetoencephalography (MEG', 'ketamine and placebo-saline infusions', 'placebo']","['Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies', 'sex or emotional valence (happy-neutral or sad-angry) of facial stimuli', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.464333,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","[{'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sepe-Forrest', 'Affiliation': 'Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Carver', 'Affiliation': 'Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Pharmaceuticals of Johnson and Johnson Inc., San Diego, CA, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA;. Electronic address: nugenta@mail.nih.gov.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.007']
1287,33076866,Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania.,"BACKGROUND


Globally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).
METHODS


GIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.
DISCUSSION


This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
TRIAL REGISTRATION


This trial is registered with ClinicalTrials.gov ( NCT04233242 ; registered 18.01.2020). More information: www.givemove.org .",2020,"This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
","['children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART', 'children and adolescents with elevated viremia while taking ART', 'children and adolescents, who experience high rates of treatment failure', 'children and adolescents (≥6\u2009months to <19\u2009years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART', '276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up', 'children and adolescents living with HIV in Lesotho and Tanzania']","['control arm receiving the standard of care (3 sessions of enhanced adherence counselling', 'genotypic resistance testing (GRT']","['occurrence of any one or more of the following events during the 36\u2009weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24\u2009h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043236', 'cui_str': 'Worldwide Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0041316', 'cui_str': 'Tuberculous adenitis'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019342', 'cui_str': 'Genital herpes simplex'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0239295', 'cui_str': 'Candidiasis of the esophagus'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",276.0,0.292711,"This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
","[{'ForeName': 'Jennifer Anne', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Ringera', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Ezekiel', 'Initials': 'E', 'LastName': 'Luoga', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Molisana', 'Initials': 'M', 'LastName': 'Cheleboi', 'Affiliation': 'Seboche Mission Hospital, Seboche, Lesotho.'}, {'ForeName': 'Namvua', 'Initials': 'N', 'LastName': 'Kimera', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Buntshi Paulin', 'Initials': 'BP', 'LastName': 'Kayembe', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Molapo Hlasoa', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Kabundi', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Ching Wey David', 'Initials': 'CWD', 'LastName': 'Yav', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Buoang', 'Initials': 'B', 'LastName': 'Mothobi', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lineo', 'Initials': 'L', 'LastName': 'Thahane', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bachmann', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Getrud Joseph', 'Initials': 'GJ', 'LastName': 'Mollel', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Daniel Henry', 'Initials': 'DH', 'LastName': 'Paris', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Weisser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland. n.labhardt@swisstph.ch.'}]",BMC infectious diseases,['10.1186/s12879-020-05491-9']
1288,33075067,"Anthelminthic treatment receipt and its predictors in Lake Victoria fishing communities, Uganda: Intervention coverage results from the LaVIISWA cluster randomised trial.","BACKGROUND


Mass drug administration (MDA) is a cornerstone of control of parasitic helminths. In schistosomiasis-endemic areas with >50% of school-aged children infected, community-wide MDA with praziquantel is recommended by the World Health Organisation (WHO), with target coverage of >75%. Using data from a cluster-randomised trial of MDA treatment strategies, we aimed to describe the proportion of eligible residents who received MDA and predictors of treatment receipt, and to assess associations with helminth prevalence.
METHODS


In the Koome islands of Lake Victoria, Uganda, where baseline schistosomiasis prevalence (by single stool sample, Kato Katz) was 52% overall (all ages) and 67% among school-aged children, we conducted a cluster-randomised trial of community-wide, intensive MDA (quarterly single-dose praziquantel 40mg/kg; triple-dose albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole). Twenty-six fishing villages were randomised, 13 per trial arm, for four years. At each treatment round, praziquantel treatment and the first dose of albendazole treatment were directly observed by the study team, registers of village residents were updated and the proportion receiving treatment among those eligible recorded.
RESULTS


During the four-year MDA, at each treatment round an average of 13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively). Overall, the proportion of those eligible receiving praziquantel was lower than for albendazole (60% versus 65%), particularly in the standard arm (61% versus 71%) compared to the intensive arm (60% versus 62%). Albendazole receipt was lower when given concurrently with praziquantel. Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel). Proportions receiving treatment were lowest among school-aged children, but did not differ by sex. Longitudinal analysis of a subgroup of residents who did not move during the study period found that persistent non-receipt of treatment in this subgroup was rare. Refusal to receive treatment was highest among adults and more common among females.
CONCLUSION


In schistosomiasis high-risk communities, a combination of approaches to increasing treatment coverage, such as extended periods of treatment delivery, and the provision of incentives, may be required to achieve WHO targets.",2020,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","['Twenty-six fishing villages', '13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively']","['MDA', 'Albendazole', 'albendazole, 18% praziquantel', 'albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole', 'albendazole', 'praziquantel']",[],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],,0.133095,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","[{'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Akurut', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lubyayi', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nampijja', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kizza', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kaweesa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kizindo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Sewankambo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nsubuga', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Edridah', 'Initials': 'E', 'LastName': 'Tukahebwa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Narcis B', 'Initials': 'NB', 'LastName': 'Kabatereine', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008718']
1289,33075100,Fitbit wear-time and patterns of activity in cancer survivors throughout a physical activity intervention and follow-up: Exploratory analysis from a randomised controlled trial.,"OBJECTIVE


There has been growing interest in the use of smart wearable technology to promote physical activity (PA) behaviour change. However, little is known concerning PA patterns throughout an intervention or engagement with trackers. The objective of the study was to explore patterns of Fitbit-measured PA and wear-time over 24-weeks and their relationship to changes in Actigraph-derived moderate-to-vigorous PA (MVPA).
METHODS


Twenty-nine intervention participants (88%) from the wearable activity technology and action-planning (WATAAP) trial in colorectal and endometrial cancer survivors accepted a Fitbit friend request from the research team to permit monitoring of Fitbit activity. Daily steps and active minutes were recorded for each participant over the 12-week intervention and throughout the follow-up period to 24-weeks. Accelerometer (GT9X) derived MVPA was assessed at end of intervention (12-weeks) and end of follow-up (24-weeks).
RESULTS


Fitbit wear-time over the 24-weeks of data was remarkably consistent, with median adherence score of 100% for all weeks. During the intervention, participants recorded a median 8006 steps/day. Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039). Actigraph and Fitbit derived measures were highly correlated but demonstrated poor agreement overall. Fitbit measured activity was closest to MVPA measured using Freedson cut-points as no bias was observed.
CONCLUSIONS


Step count was maintained throughout the trial displaying promise for the effectiveness of smart-wearable interventions to reduce sedentary behaviour beyond the intervention period. Further worthwhile work should compare more advanced smart-wearable technology with accelerometers in order to improve agreement and explore less resource-intensive methods to assess PA that could be scalable.",2020,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"['Twenty-nine intervention participants (88%) from the', 'cancer survivors', 'in colorectal and endometrial cancer survivors']","['physical activity intervention', 'wearable activity technology and action-planning (WATAAP) trial']","['median adherence score', 'Daily step count']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.051742,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hardcastle', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Jiménez-Castuera', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Maxwell-Smith', 'Affiliation': 'School of Psychology, Curtin University, Bentley, Perth, Western Australia, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hince', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0240967']
1290,33076273,Effect of New Zealand Blackcurrant Extract on Isometric Contraction-Induced Fatigue and Recovery: Potential Muscle-Fiber Specific Effects.,"New Zealand blackcurrant (NZBC) extract has shown performance-enhancing effects during cycling, running and sport climbing. We examined effects of NZBC extract on (1) voluntary and twitch force of the  quadriceps femoris muscles  during repeated isometric contraction-induced fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects. Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen, 5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest. Twitch force was recorded before, during the 3-s rests and 5-min recovery. Supplementation consisted of 7-days intake of NZBC extract (600 mg∙day -1  containing 210 mg anthocyanin) in a double-blind, randomized, placebo-controlled crossover design with a 14-days washout. NZBC extract allowed for greater force in the first quartile of the iMVCs. Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05). However, there was no effect of NZBC for twitch force during the 16-iMVCs and recovery. Based on the maximum post-activation potentiation during the placebo 16-iMVCs, four subjects were classified of having a predominant type I or II muscle fiber typology. In type II, NZBC extract provided a trend for increased MVC force (~14%) in the first quartile and for type I in the fourth quartile (~10%). In type I, NZBC extract seemed to have higher twitch forces during the fatiguing exercise protocol and recovery, indicating increased fatigue resistance. New Zealand blackcurrant extract affects force during repeated maximal isometric contractions. Future work on mechanisms by NZBC extract for muscle fiber-specific fatigue-induced force responses is warranted.",2020,Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05).,"['Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen']","['New Zealand blackcurrant (NZBC) extract', 'NZBC', 'placebo', 'NZBC extract', 'New Zealand Blackcurrant Extract', 'NZBC extract (600 mg∙day -1  containing 210 mg anthocyanin', '5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest']","['twitch forces', 'fatigue resistance', 'Twitch force', 'fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects', 'MVC force']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",4.0,0.172571,Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05).,"[{'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradley', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100135']
1291,32673060,Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.,"BACKGROUND


No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).
OBJECTIVE


To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.
DESIGN


Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).
SETTING


Internet-based trial across the United States and Canada (40 states and 3 provinces).
PARTICIPANTS


Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.
INTERVENTION


Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.
MEASUREMENTS


Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
RESULTS


Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point];  P  = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo ( P  = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo ( P  < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
LIMITATION


Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.
CONCLUSION


Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.
PRIMARY FUNDING SOURCE


Private donors.",2020,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","['outpatients with early, mild COVID-19', 'Nonhospitalized Adults', '22 March through 20 May 2020', '341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting', 'Internet-based trial across the United States and Canada', 'Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset', 'adult outpatients', '491 patients randomly assigned to a group, 423 contributed primary end point data']","['hydroxychloroquine', 'Hydroxychloroquine', 'Early COVID-19', 'Oral hydroxychloroquine', 'placebo']","['ongoing symptoms', 'overall symptom severity', '10-point visual analogue scale', 'Medication adverse effects', 'symptom severity', 'hospitalized death', 'Change in symptom severity', 'COVID-19 severity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",423.0,0.761778,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","[{'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Darlette', 'Initials': 'D', 'LastName': 'Luke', 'Affiliation': 'M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (I.S.S.).'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}]",Annals of internal medicine,['10.7326/M20-4207']
1292,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1293,32682696,Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial.,"RATIONALE & OBJECTIVE


Most adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care.
STUDY DESIGN


Pragmatic cluster-randomized trial.
SETTING & PARTICIPANTS


524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m 2  cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment.
INTERVENTIONS


Each PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS).
OUTCOMES


The primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy.
RESULTS


All 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m 2 . Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002).
LIMITATIONS


Recruitment of smaller than intended sample size and limited uptake of the testing component of the intervention.
CONCLUSIONS


Although we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD.
FUNDING


Grants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT02925962.",2020,"PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS -PLUS (p=0.09).","[' 524 adults with confirmed eGFRCr 30-59 mL/min/1.73m 2  cared for by 80 PCPs at the University of California San Francisco', 'Mean patient age was 70, 47% were non-white, mean eGFRcr was 56 +/-0.6', 'Primary Care', 'All 80 eligible PCPs participated', 'patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed labs and 138 (41%) had labs followed by a PCP visit with eCDSS deployment', 'adults with chronic kidney disease (CKD) in the U.S. are cared for by primary care providers (PCP']","['eCDSS', 'electronic clinical decision support system (eCDSS', 'usual care, 2) eCDSS: testing of creatinine, cystatin C and urinary albumin-to-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium and proteinuria management, cardiovascular risk-reduction, and patient education, or 3) eCDSS plus pharmacist counseling (eCDSS-PLUS']","['blood pressure', 'blood pressure, and uptake of the eCDSS', 'PCP awareness of CKD', 'systolic blood pressure', 'PCP awareness of CKD as well as use of ACEi/ARB and statin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",524.0,0.0628094,"PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS -PLUS (p=0.09).","[{'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Peralta', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; The Kidney Health Research Collaborative, University of California San Francisco, San Francisco, CA; Cricket Health, Inc, San Francisco, CA. Electronic address: carmenalicia.peralta@ucsf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Livaudais-Toman', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stebbins', 'Affiliation': 'Department of Clinical PharmacyUniversity of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scherzer', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; The Kidney Health Research Collaborative, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Karliner', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.05.013']
1294,32682705,Evaluation of Three Field Rewarming Techniques During Cold Weather Military Training.,"INTRODUCTION


The purpose of this work was to evaluate the effectiveness of 3 rewarming techniques to determine how warfighters, and perhaps other populations in wilderness environments, should prioritize field rewarming options after a brief accidental immersion in cold water.
METHODS


As part of a cold weather military training exercise, 31 military personnel (mean±SD age: 26±5 y, height: 180±10 cm, weight: 83.2±10.9 kg) completed a 10-min immersion in cold (0°C) water and subsequently rewarmed for 60 min using 3 different field rewarming techniques (sleeping bag, sleeping bag + warm fluids, or exercise). Heart rate, core and skin temperatures, thermal and shivering sensations, and manual dexterity (intravenous setup and insertion) were measured during the training exercise.
RESULTS


Cold water immersion decreased core temperature (pre: 37.4±0.4; post: 36.4±1.0°C; P<0.001) and mean skin temperature (pre: 27.9±1.3; post: 15.6±1.8°C; P<0.001) and impaired manual dexterity (intravenous insertion time, pre: 71±12, post: 166±48 s; P<0.001). Recovery from mild cold stress was similar among all 3 rewarming techniques for all measurements.
CONCLUSIONS


Findings suggesting similar rewarming responses in field settings are beneficial for the warfighter, and perhaps others, in that rewarming options exist and can be implemented with no compromise in recovery from cold stress.",2020,"RESULTS


Cold water immersion decreased core temperature (pre: 37.4±0.4; post: 36.4±1.0°C; P<0.001) and mean skin temperature","['31 military personnel (mean±SD age: 26±5 y, height: 180±10 cm, weight: 83.2±10.9 kg) completed a']","['Field Rewarming Techniques', '10-min immersion in cold (0°C) water and subsequently rewarmed for 60 min using 3 different field rewarming techniques (sleeping bag, sleeping bag\xa0+ warm fluids, or exercise']","['core temperature', 'manual dexterity (intravenous insertion time, pre', 'mean skin temperature', 'Heart rate, core and skin temperatures, thermal and shivering sensations, and manual dexterity (intravenous setup and insertion']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0836842,"RESULTS


Cold water immersion decreased core temperature (pre: 37.4±0.4; post: 36.4±1.0°C; P<0.001) and mean skin temperature","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Leidos, Inc., San Diego, CA; Warfighter Performance Department, Naval Health Research Center, San Diego, CA. Electronic address: douglas.m.jones@leidos.com.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Bowles', 'Affiliation': 'Marine Corps Mountain Warfare Training Center, Bridgeport, CA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Bergquist-Turori', 'Affiliation': 'Leidos, Inc., San Diego, CA; Warfighter Performance Department, Naval Health Research Center, San Diego, CA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Leidos, Inc., San Diego, CA; Warfighter Performance Department, Naval Health Research Center, San Diego, CA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Rostomily', 'Affiliation': 'Leidos, Inc., San Diego, CA; Warfighter Performance Department, Naval Health Research Center, San Diego, CA.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Pautz', 'Affiliation': 'Innovative Employee Solutions, San Diego, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Heaney', 'Affiliation': 'Warfighter Performance Department, Naval Health Research Center, San Diego, CA.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2020.04.002']
1295,33066103,Transcutaneous Spinal Cord Stimulation Enhances Quadriceps Motor Evoked Potential in Healthy Participants: A Double-Blind Randomized Controlled Study.,"Transcutaneous electrical spinal cord stimulation (tSCS) is a non-invasive technique for neuromodulation and has therapeutic potential for motor rehabilitation following spinal cord injury. The main aim of the present study is to quantify the effect of a single session of tSCS on lower limb motor evoked potentials (MEPs) in healthy participants. A double-blind, sham-controlled, randomized, crossover, clinical trial was carried out in 15 participants. Two 10-min sessions of tSCS (active-tSCS and sham-tSCS) were applied at the T11-T12 vertebral level. Quadriceps (Q) and tibialis anterior (TA) muscle MEPs were recorded at baseline, during and after tSCS. Q and TA isometric maximal voluntary contraction was also recorded. A significant increase of the Q-MEP amplitude was observed during active-tSCS (1.96 ± 0.3 mV) when compared from baseline (1.40 ± 0.2 mV;  p  = 0.01) and when compared to sham-tSCS at the same time-point (1.13 ± 0.3 mV;  p  = 0.03). No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength. In conclusion, tSCS applied over the T11-T12 vertebral level increased Q-MEP but not TA-MEP compared to sham stimulation. The specific neuromodulatory effect of tSCS on Q-MEP may reflect optimal excitation of this motor response at the interneuronal or motoneuronal level.",2020,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"['15 participants', 'healthy participants', 'Healthy Participants']","['tSCS', 'Transcutaneous Spinal Cord Stimulation', 'tSCS (active-tSCS and sham-tSCS', 'Transcutaneous electrical spinal cord stimulation (tSCS']","['TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength', 'Q-MEP amplitude', 'lower limb motor evoked potentials (MEPs', 'T11-T12 vertebral level increased Q-MEP', 'Q and TA isometric maximal voluntary contraction', 'Quadriceps (Q) and tibialis anterior (TA) muscle MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0446409', 'cui_str': 'Vertebral level'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.247662,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Megía-García', 'Affiliation': 'Biomechanical and Technical Aids Unit, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Serrano-Muñoz', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Sensorimotor Function Group, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Comino-Suárez', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Soriano', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103275']
1296,33066761,"A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV-2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol.","BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the causative agent of coronavirus disease 2019 (COVID-19), may lead to severe systemic inflammatory response, pulmonary damage, and even acute respiratory distress syndrome (ARDS). This in turn may result in respiratory failure and in death. Experimentally, acetylcholine (ACh) modulates the acute inflammatory response, a neuro-immune mechanism known as the inflammatory reflex. Recent clinical evidence suggest that electrical and chemical stimulation of the inflammatory reflex may reduce the burden of inflammation in chronic inflammatory diseases. Pyridostigmine (PDG), an ACh-esterase inhibitor (i-ACh-e), increases the half-life of endogenous ACh, therefore mimicking the inflammatory reflex. This clinical trial is aimed at evaluating if add-on of PDG leads to a decrease of invasive mechanical ventilation and death among patients with severe COVID-19.
METHODS


A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O. to reduce the need for invasive mechanical ventilation and mortality in hospitalized patients with severe COVID-19.
DISCUSSION


This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04343963 (registered on April 14, 2020).",2020,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","['Severe acute respiratory syndrome coronavirus 2', 'patients with severe COVID-19', 'hospitalized patients with severe COVID-19', 'adults with severe SARS-CoV-2 infection']","['acetylcholine (ACh', 'Pyridostigmine', 'pyridostigmine bromide', 'placebo', 'Pyridostigmine (PDG']","['invasive mechanical ventilation and death', 'mortality or invasive mechanical ventilation']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.747485,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fragoso-Saavedra', 'Affiliation': 'Programa de Estudios Combinados en Medicina (MD/PhD program), Universidad Nacional Autónoma de Mexico, Mexico City, Mexico.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Iruegas-Nunez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Quintero-Villegas', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'H Benjamín', 'Initials': 'HB', 'LastName': 'García-González', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nuñez', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Carbajal-Morelos', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Belem M', 'Initials': 'BM', 'LastName': 'Audelo-Cruz', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sarahi', 'Initials': 'S', 'LastName': 'Arias-Martínez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Yanink', 'Initials': 'Y', 'LastName': 'Caro-Vega', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Calva', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Luqueño-Martínez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crabtree-Ramírez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Crispín', 'Affiliation': 'Departamento de e Inmunología y Reumatología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sierra-Madero', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Belaunzarán-Zamudio', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio I', 'Initials': 'SI', 'LastName': 'Valdés-Ferrer', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. sergio.valdesf@incmnsz.mx.'}]",BMC infectious diseases,['10.1186/s12879-020-05485-7']
1297,33067919,Effectiveness of a low-dose mindfulness-based intervention for alleviating distress in young unemployed adults.,"While the effectiveness of mindfulness-based interventions (MBIs) with respect to distress has been widely researched, unemployed individuals, who often suffer from high levels of distress, have largely been neglected in MBI research. The present study aimed to investigate the effects of a low-dose MBI on distress in a sample of young unemployed adults. The sample included 239 young unemployed adults enrolled for a 6-week long employability-related training camp. Participants were allocated into an intervention group that received weekly 1-hour mindfulness training over 4 weeks, and a control group. Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training. A mixed model ANCOVA showed that distress was inversely and significantly predicted by baseline levels of mindfulness and well-being. After accounting for the baseline levels of mindfulness and well-being, a significant effect of the mindfulness intervention was evident. This result shows that a low-dose MBI can decrease distress in a sample of young unemployed adults and its effectiveness is positively associated with initial levels of dispositional mindfulness and well-being.",2020,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","['239 young unemployed adults enrolled for a six-week long employability-related training camp', 'young unemployed adults', 'Young Unemployed Adults']","['mindfulness-based interventions (MBIs', 'Low-dose Mindfulness-based Intervention', 'low-dose MBI']","['distress', 'Dispositional mindfulness, distress and well-being']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",239.0,0.0182494,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Roemer', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Grimm', 'Affiliation': 'New Zealand Defence Force, Wellington, New Zealand.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2997']
1298,33068667,"Mindfulness, mood, and food: The mediating role of positive affect.","With rates of overweight and obesity rising worldwide, it is important to examine psychological factors associated with food intake. Previous research has shown that mindfulness may serve as a protective factor against overconsumption of food. Some studies have posited that mindfulness addresses unhealthy eating by promoting the increased awareness of, and decreased responsiveness to, internal emotional cues. The present study investigated the effects of a brief mindfulness induction on positive and negative affect and subsequent energy intake in a sample of undergraduate students (N = 126). After exposure to a negative mood induction, 63 participants were randomly assigned to a brief mindfulness intervention, while the remaining participants listened to a news article. Subsequently all participants were offered healthful and unhealthful snack foods. Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake. Relative to controls, those in the experimental condition reported higher positive affect after the mindfulness induction, which in turn reduced their energy intake. Further exploratory analyses indicated that positive affect in the experimental group was associated with reduced consumption of unhealthful food. These findings provide insight into how mindfulness-based interventions may target unhealthy eating behaviors.",2020,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","['63 participants', 'a sample of undergraduate students (N = 126']","['brief mindfulness intervention, while the remaining participants listened to a news article']","['positive and negative affect and subsequent energy intake', 'Mindfulness, Mood, and Food']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0282425', 'cui_str': 'News'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",63.0,0.0206694,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","[{'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, U.S.A. Electronic address: ti-hsu@uiowa.edu.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Forestell', 'Affiliation': 'Department of Psychological Sciences, William & Mary, P.O. Box 8795, Williamsburg, VA, 23187-8795, USA. Electronic address: caforestell@wm.edu.'}]",Appetite,['10.1016/j.appet.2020.105001']
1299,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5)  = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5)  = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
1300,33069106,Brief mindfulness training for smoking cessation in Chinese women in workplaces: A pilot randomized controlled trial.,"INTRODUCTION


Mindfulness training (MT) has shown preliminary efficacy as a behavioral treatment for smoking cessation. We examined the effect of a brief-MT intervention on smoking cessation for Chinese women in workplaces in Hong Kong, China.
METHODS


In this pilot randomized controlled trial, 213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n = 114) or control (n = 99) groups. Participants in both groups received a self-help booklet. Participants in the intervention group additionally attended 2 sessions of a brief-MT workshop. The primary outcome was self-reported 7-day point-prevalence abstinence (PPA) at 6 months. Secondary outcomes were biochemically validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/mL) and smoking reduction at 6 months. Analyses were done by intention to treat. We conducted a post-trial qualitative evaluation on participants in the intervention group (n = 14). Data were analyzed thematically.
RESULTS


At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61). Very few participated in biochemical validation (n = 17), and validated abstinence and smoking reduction rates showed no significant difference (5.3% vs. 11.1%, P = 0.12 and 20.2% vs. 20.2%, P = 1.00, respectively). A posteriori analysis showed that brief-MT participants who were psychologically engaged with the intervention had greater 6-month PPA. Qualitative evaluation showed brief-MT reduced stress but its effectiveness was restrained by the insufficient home practice.
CONCLUSIONS


This pilot trial on a brief-MT intervention for smoking cessation on Chinese women in workplaces showed feasibility, but improving compliance is needed to maximize the efficacy in future fully powered trials.",2020,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","['Chinese women in workplaces', 'participants in the intervention group (n\xa0=\xa014', 'Chinese women in workplaces in Hong Kong, China', '213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n\xa0=\xa0114) or control (n\xa0=\xa099) groups']","['self-help booklet', 'Mindfulness training (MT', 'MT intervention', 'brief-MT intervention', 'Brief mindfulness training']","['validated abstinence and smoking reduction rates', 'smoking reduction', '6-month PPA', 'smoking cessation', '7-day PPA', 'self-reported 7-day point-prevalence abstinence (PPA', 'salivary cotinine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",213.0,0.102459,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oi Sze', 'Initials': 'OS', 'LastName': 'Lau', 'Affiliation': 'The Lok Sin Tong Benevolent Society Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jojo Yan Yan', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China. Electronic address: mpwang@hku.hk.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106677']
1301,33069109,Behavioral modification decreases approach bias in young adults with internet gaming disorder.,"BACKGROUND


One of the key symptoms of Internet gaming disorder is the impulsive pursuit of Internet games, which causes individuals with this disorder to have a tendency to approach gaming cues. Dual processing theory states that this approach bias is caused by the suppression of reflective processing and the hyperactivity of impulsive processing. Therefore, reverse modification training for approach bias can suppress impulsive processing, thereby reducing or treating the disorder.
METHOD


In this study, 48 individuals with Internet gaming disorder were selected and randomly assigned to the following two groups: the experimental group and the control group. The 24 participants in the experimental group received a 4-day stimulus-response compatibility (SRC) approach bias modification treatment, whereas the 24 participants in the control group received a corresponding SRC pseudomodification training.
RESULTS


The approach response time of both groups to the gaming cues was significantly shorter than that to the neutral cues at baseline. After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased. However, the control group subjects did not show these effects.
CONCLUSION


The current results imply that individuals with Internet gaming disorder show approach bias toward Internet gaming cues, and SRC reverse modification training can significantly correct this bias and therefore have therapeutic effects to some extent.",2020,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","['young adults with internet gaming disorder', 'individuals with Internet gaming disorder', '48 individuals with Internet gaming disorder']","['4-day stimulus-response compatibility (SRC) approach bias modification treatment', 'corresponding SRC pseudomodification training', 'Behavioral modification']","['scores for Internet gaming disorder severity, anxiety level and craving', 'response time', 'gaming cues']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",48.0,0.0253849,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","[{'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China. Electronic address: hjb@mail.ccnu.edu.cn.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106686']
1302,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES


Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS


We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS


We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS


The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION


Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1303,33073298,"Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study.","A variety of applications of human adipose tissue stem cell-derived exosomes have been suggested as novel cell-free therapeutic strategies in the regenerative and aesthetic medical fields. This study evaluated the clinical efficacy and safety of adipose tissue stem cell-derived exosomes as an adjuvant therapy after application of fractional CO2 laser for acne scars. A 12-week prospective, double-blind, randomized, split-face trial was performed. A total of 25 patients received 3 consecutive treatment sessions of fractional CO2 laser to the whole face, with a follow-up evaluation. Post-laser treatment regimens were applied; for each patient, one side of the face was treated with adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel. Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01). Treatment-related erythema was milder, and post-treatment downtime was shorter on the human adipose tissue stem cell-derived exosomes-treated side. In conclusion, the combined use of this novel material with resurfacing devices would provide synergistic effects on both the efficacy and safety of atrophic acne scar treatments.",2020,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","['acne scars', 'Acne Scars', '25 patients']","['fractional CO2 laser', 'Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser', 'adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel', 'adipose tissue stem cell-derived exosomes']",['Adipose tissue stem cell'],"[{'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",25.0,0.0249087,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","[{'ForeName': 'Hyuck Hoon', 'Initials': 'HH', 'LastName': 'Kwon', 'Affiliation': 'Oaro Dermatology Institute, Seoul, Korea.'}, {'ForeName': 'Steven Hoseong', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Byung Cheol', 'Initials': 'BC', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Kui Young', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Youin', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Gyeong-Hun', 'Initials': 'GH', 'LastName': 'Park', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3666']
1304,33074597,Copper nanoparticles as nanofillers in an adhesive resin system: An in vitro study.,"BACKGROUND


The incorporation of an antibacterial agent into an adhesive could improve its clinical performance. Some nanoparticles (NPs), including copper nanoparticles (Cu NPs), display an antibacterial effect. Therefore, Cu NPs could act as a nanofiller when added to an adhesive.
OBJECTIVES


The aim of this study was to evaluate the antibacterial activity, cytotoxicity and shear bond strength (SBS) of an experimental dental adhesive with Cu NPs.
MATERIAL AND METHODS


Different concentrations (0.0050 wt%, 0.0075 wt% and 0.0100 wt%) of Cu NPs were added to the adhesive. The distribution of Cu NPs in the polymer matrix was observed based on transmission electron microscope (TEM) images. The antimicrobial activity of the adhesive + Cu NPs was evaluated with the agar disk diffusion test against Staphylococcus aureus (S. aureus), Escherichia coli (E. coli) and Streptococcus mutans (S. mutans). The cytotoxicity assay was performed by means of the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) method with human pulp cells (HPC). Additionally, the SBS tests were carried out (n = 31) and the modes of fracture were registered. The vestibular and lingual surfaces of each tooth were randomly assigned to the study groups (group I - control adhesive; group II - adhesive + 0.0100 wt% Cu NPs). The samples were statistically analyzed (p ≤ 0.05).
RESULTS


The adhesive + 0.0100 wt% Cu NPs showed inhibition zones against the strains under study that were similar to, or slightly smaller than, the halos produced by chlorhexidine (CHX) and specific drugs for each strain (30 μg of cefotaxime against S. mutans and S. aureus, and 1.25/3.75 μg of sulfamethoxazole/ trimethoprim against E. coli). The control adhesive was moderately cytotoxic (relative cell viability of 36.7 ±0.8%), being more cytotoxic than Cu NPs themselves (58.3 ±0.1%). A significantly higher SBS was obtained for the adhesive + 0.0100 wt% Cu NPs (6.038 ±2.95 MPa) than for the control group (3.278 ±1.75 MPa). The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
CONCLUSIONS


The results of this study suggest that incorporating Cu NPs into an adhesive improves its SBS and provides it with antibacterial properties, without increasing its inherent cytotoxicity - 2 desirable characteristics for the dental adhesives of composites.",2020,"The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
",['adhesive resin system'],"['control adhesive; group II - adhesive + 0.0100 wt', 'adhesive ', 'MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) method with human pulp cells (HPC', 'chlorhexidine (CHX']","['antimicrobial activity', 'antibacterial activity, cytotoxicity and shear bond strength (SBS', 'SBS']","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0647210', 'cui_str': 'monooxyethylene trimethylolpropane tristearate'}, {'cui': 'C0094912', 'cui_str': '3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",31.0,0.028001,"The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Torres-Rosas', 'Affiliation': 'Laboratory of Biomaterials, Center for Studies in Health and Disease Sciences, School of Dentistry, Benito Juárez Autonomous University of Oaxaca, Oaxaca de Juárez, Mexico.'}, {'ForeName': 'Nayely', 'Initials': 'N', 'LastName': 'Torres-Gómez', 'Affiliation': 'Technological Institute of Toluca, Metepec, Mexico.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'García-Contreras', 'Affiliation': 'Laboratory of Interdisciplinary Research, Area of Nanostructures and Biomaterials, National School of Higher Studies León Unit, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Rogelio José', 'Initials': 'RJ', 'LastName': 'Scougall-Vilchis', 'Affiliation': 'Department of Orthodontics, Center for Research and Advanced Studies in Dentistry, Autonomous University of Mexico State, Mexico City, Mexico.'}, {'ForeName': 'Luis Roberto', 'Initials': 'LR', 'LastName': 'Domínguez-Díaz', 'Affiliation': 'National Technological Institute of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Argueta-Figueroa', 'Affiliation': 'Cátedras CONACYT - School of Dentistry, Benito Juárez Autonomous University of Oaxaca, Oaxaca de Juárez, Mexico.'}]",Dental and medical problems,['10.17219/dmp/121973']
1305,33079935,Randomized nutrient bar supplementation improves exercise-associated changes in plasma metabolome in adolescents and adult family members at cardiometabolic risk.,"BACKGROUND


Poor diets contribute to metabolic complications of obesity, insulin resistance and dyslipidemia. Metabolomic biomarkers may serve as early nutrition-sensitive health indicators. This family-based lifestyle change program compared metabolic outcomes in an intervention group (INT) that consumed 2 nutrient bars daily for 2-months and a control group (CONT).
METHODS


Overweight, predominantly minority and female adolescent (Teen)/parent adult caretaker (PAC) family units were recruited from a pediatric obesity clinic. CONT (8 Teen, 8 PAC) and INT (10 Teen, 10 PAC) groups randomized to nutrient bar supplementation attended weekly classes that included group nutrition counseling and supervised exercise. Pre-post physical and behavioral parameters, fasting traditional biomarkers, plasma sphingolipids and amino acid metabolites were measured.
RESULTS


In the full cohort, a baseline sphingolipid ceramide principal component composite score correlated with adiponectin, triglycerides, triglyceride-rich very low density lipoproteins, and atherogenic small low density lipoprotein (LDL) sublasses. Inverse associations were seen between a sphingomyelin composite score and C-reactive protein, a dihydroceramide composite score and diastolic blood pressure, and the final principal component that included glutathionone with fasting insulin and the homeostatic model of insulin resistance. In CONT, plasma ceramides, sphinganine, sphingosine and amino acid metabolites increased, presumably due to increased physical activity. Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites. Metabolomic changes were positively correlated with improvements in clinical biomarkers of dyslipidemia.
CONCLUSION


Nutrient bar supplementation with increased physical activity in obese Teens and PAC elicits favorable metabolomic changes that correlate with improved dyslipidemia. The trial from which the analyses reported upon herein was part of a series of nutrient bar clinical trials registered at clinicaltrials.gov as NCT02239198.",2020,"Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites.","['Overweight, predominantly minority and female adolescent (Teen)/parent adult caretaker (PAC) family units were recruited from a pediatric obesity clinic', 'adolescents and adult family members at cardiometabolic risk']","['Nutrient bar supplementation', 'nutrient bar supplementation attended weekly classes that included group nutrition counseling and supervised exercise', 'Nutrient bar supplementation (INT']","['Pre-post physical and behavioral parameters, fasting traditional biomarkers, plasma sphingolipids and amino acid metabolites', 'plasma ceramides, sphinganine, sphingosine and amino acid metabolites', 'sphingomyelin composite score and C-reactive protein, a dihydroceramide composite score and diastolic blood pressure', 'clinical biomarkers of dyslipidemia', 'physical activity', 'dyslipidemia', 'ureagenic, aromatic and gluconeogenic amino acid metabolites', 'adiponectin, triglycerides, triglyceride-rich very low density lipoproteins, and atherogenic small low density lipoprotein (LDL) sublasses', 'plasma metabolome']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0037900', 'cui_str': 'Sphingolipid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0074987', 'cui_str': 'sphinganine'}, {'cui': 'C0037907', 'cui_str': 'Sphingosine'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0668446', 'cui_str': 'dihydroceramide'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.038699,"Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mietus-Snyder', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington DC, United States of America.""}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Narayanan', 'Affiliation': 'Weill Cornell Medical College, Cornell University, New York, New York, United States of America.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ""University of California Benioff Children's Hospital San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Laine-Graves', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Joyce C', 'Initials': 'JC', 'LastName': 'McCann', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Shigenaga', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Tara H', 'Initials': 'TH', 'LastName': 'McHugh', 'Affiliation': 'United States Department of Agriculture, Western Regional Research Center, Albany, California, United States of America.'}, {'ForeName': 'Bruce N', 'Initials': 'BN', 'LastName': 'Ames', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0240437']
1306,33079959,Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model.,"Enteric fever is a systemic infection caused by Salmonella Typhi or Paratyphi A. In many endemic areas, these serovars co-circulate and can cause multiple infection-episodes in childhood. Prior exposure is thought to confer partial, but incomplete, protection against subsequent attacks of enteric fever. Empirical data to support this hypothesis are limited, and there are few studies describing the occurrence of heterologous-protection between these closely related serovars. We performed a challenge-re-challenge study using a controlled human infection model (CHIM) to investigate the extent of infection-derived immunity to Salmonella Typhi or Paratyphi A infection. We recruited healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies. Within each group, participants were randomised 1:1 to oral challenge with either Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU). The primary objective was to compare the attack rate between naïve and previously challenged individuals, defined as the proportion of participants per group meeting the diagnostic criteria of temperature of ≥38°C persisting for ≥12 hours and/or S. Typhi/Paratyphi bacteraemia up to day 14 post challenge. The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24). Homologous re-challenge with Salmonella Paratyphi A also resulted in a lower attack-rate than was seen in challenged naïve controls (3/12[25%] vs. 10/18[56%]; RR0.45; 95% CI 0.16-1.30; p = 0.14). Evidence of protection was supported by a post hoc analysis in which previous exposure was associated with an approximately 36% and 57% reduced risk of typhoid or paratyphoid disease respectively on re-challenge. Individuals who did not develop enteric fever on primary exposure were significantly more likely to be protected on re-challenge, compared with individuals who developed disease on primary exposure. Heterologous re-challenge with Salmonella Typhi or Salmonella Paratyphi A was not associated with a reduced attack rate following challenge. Within the context of the model, prior exposure was not associated with reduced disease severity, altered microbiological profile or boosting of humoral immune responses. We conclude that prior Salmonella Typhi and Paratyphi A exposure may confer partial but incomplete protection against subsequent infection, but with a comparable clinical and microbiological phenotype. There is no demonstrable cross-protection between these serovars, consistent with the co-circulation of Salmonella Typhi and Paratyphi A. Collectively, these data are consistent with surveillance and modelling studies that indicate multiple infections can occur in high transmission settings, supporting the need for vaccines to reduce the burden of disease in childhood and achieve disease control. Trial registration NCT02192008; clinicaltrials.gov.",2020,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).",['healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies'],"['Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU', 'Salmonella Typhi or Salmonella Paratyphi', 'Salmonella Typhi and Salmonella Paratyphi']","['lower attack-rate', 'attack rate', 'attack-rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2732504', 'cui_str': 'Exposure to Salmonella'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0036115', 'cui_str': 'Salmonella Paratyphi C'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0655881,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).","[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Norman', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Hazel C', 'Initials': 'HC', 'LastName': 'Dobinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Preciado-Llanes', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Napolitani', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Melita A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cerundulo', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008783']
1307,33080693,The long-term effect of acupuncture for patients with knee osteoarthritis: Study protocol for a randomized controlled trial.,"INTRODUCTION


Whether there is the long-term effect of acupuncture on patients with knee osteoarthritis (KOA) or not is controversial. According to the basic theory of traditional acupuncture, deqi is the key to the efficacy of acupuncture. This randomized controlled trial aims to evaluate the existence of long-term effects caused by deqi in patients with KOA.
METHODS AND ANALYSIS


A three-armed, parallel-design, randomized controlled trial is underway in China.108 KOA patients recruited by the rehabilitation center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine will be randomly assigned to the acupuncture with deqi group (A group), the acupuncture without deqi group (B group) and the waiting-list group (C group). Each patient will receive 5 30-minute sessions per week for 4 consecutive weeks and rest for 2 days between treatments, and undergo a 20-week follow-up. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score). The secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), emotional monitoring and expectation scale. The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment. At the same time, adverse events (AEs) occurred in the whole process will be recorded and analyzed. We will perform an intention-to-treat analysis and protocol (PP) analysis to statistically analyze the results of the trial.
DISCUSSION


This trial will be useful to study the long-term effect of acupuncture and the influence of the deqi sensation on the long-term in the treatment of KOA, and to provide a clinical basis for treatment of patients with mild to moderate knee osteoarthritis in clinic.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, IDF: ChiCTR2000029291. Registered on January 21, 2020.",2020,The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment.,"['patients with mild to moderate knee osteoarthritis in clinic', 'patients with KOA', 'patients with knee osteoarthritis', 'patients with knee osteoarthritis (KOA', 'China.108 KOA patients recruited by the rehabilitation center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine']","['acupuncture without deqi group (B group) and the waiting-list group', 'acupuncture with deqi', 'acupuncture']","['pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS', 'Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score', 'deqi sensation', 'Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), emotional monitoring and expectation scale', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.114547,The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment.,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Xuguang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Feilai', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022599']
1308,33080728,Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial.,"BACKGROUND


To compare perioperative outcomes and surgeon physical and mental stress when performing lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS) on patients with non-small-cell lung cancer (NSCLC).
METHODS


Patients aged 41 to 73 years with resectable NSCLC were randomly assigned via a computer-generated randomisation sequence to receive either uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy between December 2015 and October 2016. Overall, we randomly assigned 35 patients to the UVATS and 34 to the MVATS group. Patients and the investigators undertaking interventions, assessing short-term outcomes, performing ergonomic evaluations, and analyzing data were not masked to group assignment.
RESULTS


Patient demographics of the 2 groups were comparable. The ergonomic evaluation considered eye blink rate and the NASA Task Load Index (NASA-TLX), better results were observed in UVATS than in MVATS. The operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function were not significantly different between the groups. Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours. No conversion, no reoperation, and no in-hospital mortality occurred in either group.
CONCLUSIONS


UVATS lobectomy is a safe and programmable technique with some better perioperative outcomes and ergonomic results than MVATS. Further studies based on large numbers of patients and with long-term follow-up are required to confirm its benefits towards patients.
TRIAL REGISTRATION


ClinicalTrials.gov ID:NCT02462356. Registered May 27, 2015.",2020,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","['Patients aged 41 to 73 years with resectable NSCLC', 'patients with non-small-cell lung cancer (NSCLC']","['uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy', 'MVATS lobectomy, UVATS lobectomy', 'lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS', 'Uniportal versus multiportal thoracoscopic lobectomy', 'UVATS lobectomy']","['eye blink rate and the NASA Task Load Index (NASA-TLX', 'hospital mortality', 'intraoperative blood loss and less volume of total drainage', 'operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",35.0,0.0965214,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022719']
1309,33080730,Effects of positive dispatcher encouragement on the maintenance of bystander cardiopulmonary resuscitation quality.,"BACKGROUND


Implementation of dispatcher-assisted cardiopulmonary resuscitation (DACPR) has increased the likelihood of bystander CPR upon cardiac arrest. However, the quality of CPR has been found to be very low. In this study, we aimed to compare CPR quality between the current DACPR practices and the interventional instruction of adding verbal encouragement from the dispatcher.
METHODS


In this randomized controlled trial, we recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training. They were randomly selected to perform DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR). The ratio of accurate compression rate, depth, and complete release for each CPR phase was examined.
RESULTS


Sixty nine records (34, mDACPR; 35, mheDACPR) were taken. The median proportion of accurate chest compression rate was initially 29.5% with mDACPR, and significantly increased to 71% after 2 minutes of CPR administration (P = .046). However, the median ratio of accurate chest compression depth was 61.5% in the first phase, and significantly decreased to 0% in the last phase (P < .001). In contrast, for the mheDACPR group, a high accurate compression rate was maintained throughout the 2 minutes of CPR administration (91%, 100%, 100%, 100%).
CONCLUSION


To maintain the quality of CPR administered by bystanders, continuous feedback and repeated human encouragement should be provided during DACPR. Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.",2020,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,['recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training'],"['dispatcher-assisted cardiopulmonary resuscitation (DACPR', 'DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR', 'positive dispatcher encouragement', 'Active dispatcher intervention']","['accurate compression rate', 'median proportion of accurate chest compression rate', 'median ratio of accurate chest compression depth', 'bystander cardiopulmonary resuscitation quality', 'ratio of accurate compression rate, depth, and complete release', 'time required to reach an appropriate CPR rate', 'CPR quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",,0.0236743,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,"[{'ForeName': 'Bo Na', 'Initials': 'BN', 'LastName': 'Hwang', 'Affiliation': 'Emergency Medicine Research Foundation, Seoul.'}, {'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Hang A', 'Initials': 'HA', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Ju Ok', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Choung Ah', 'Initials': 'CA', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}]",Medicine,['10.1097/MD.0000000000022728']
1310,33080734,Will purposely seeking detect more colorectal polyps than routine performing during colonoscopy?,"BACKGROUND & GOALS


We observed that the number of colorectal polyps found intraoperatively was often higher than that encountered preoperatively during elective colonoscopic polypectomy. To evaluate whether more polyps can be detected when they are purposely sought than when they are routinely examined during colonoscopy.
MATERIALS AND METHODS


Patients undergoing colonoscopy were randomized into groups A and B. Before colonoscopy was performed, endoscopists were instructed to seek polyps for group A purposely but not for group B. Polypectomy was electively completed. In groups A and B, the cases of elective polypectomy were named groups AR and BR, including groups AR-1 and BR-1, during the first colonoscopy and groups AR-2 and BR-2 during the second colonoscopy for polypectomy, respectively. The following data were calculated: the number of polyps detected (NPD) and the polyp detection rate (PDR) in all cases and the number of polyps missed (NPM) and partial polyp miss rate (PPMR) in the cases of colorectal polyps.
RESULTS


A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR. No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
CONCLUSION


Purposely seeking for colorectal polyps did not result in more polyps detected compared with routine colonoscopy.",2020,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","['Patients undergoing colonoscopy', 'A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR']",[],"['PPMR in group AR-1', 'number of polyps missed (NPM) and partial polyp miss rate (PPMR', 'number of polyps detected (NPD) and the polyp detection rate (PDR', 'PDR', 'PPMR between groups BR-1 and BR-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0103931', 'cui_str': 'AR-1'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",419.0,0.0195262,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","[{'ForeName': 'Yanliu', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Qinfu', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Qiao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Zhenhe', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Heye', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Enqiang', 'Initials': 'E', 'LastName': 'Linghu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000022738']
1311,33080924,The Effects of Strength and Conditioning in Physical Education on Athletic Motor Skill Competencies and Psychological Attributes of Secondary School Children: A Pilot Study.,"Leading global physical activity guidelines advocate that young children need to engage in activities that strengthen musculoskeletal tissues and improve movement skill competency. The purpose of this study was to examine the effects of delivering strength and conditioning as part of the physical education curriculum on athletic motor skill competencies (AMSC), physical performance, and psychosocial factors. Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups. Intervention groups received nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula. The resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC. Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem. Male and female intervention groups significantly improved RTSB ( p  > 0.05) whereas no changes were observed in the control groups. No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance. Significant increases in motivation of the male intervention group occurred. Strength and conditioning integrated in physical education can improve AMSC in short-term interventions.",2020,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"['young children', 'Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups', 'Secondary School Children']","['Strength and Conditioning in Physical Education', 'nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula']","['Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem', 'standing long jump performance', 'resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC', 'motivation', 'RTSB', 'athletic motor skill competencies (AMSC), physical performance, and psychosocial factors']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279901', 'cui_str': 'Firstly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",46.0,0.013785,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"[{'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Pullen', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Knight', 'Affiliation': 'Welsh Institute of Performance Science, Sport Wales, Sophia Gardens, Cardiff CF11 9SW, Wales, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100138']
1312,33080934,Plasma and Urinary (Poly)phenolic Profiles after 4-Week Red Raspberry ( Rubus idaeus  L.) Intake with or without Fructo-Oligosaccharide Supplementation.,"Red raspberries (RRB) are high in anthocyanin- and ellagitannin- type (poly)phenols. This study aimed to investigate the effect of 4-week RRB supplementation on (poly)phenolic metabolism in adults with prediabetes and insulin-resistance (PreDM-IR); and whether adding fructo-oligosaccharides (FOS), prebiotics, would augment the microbial metabolites of RRB (poly)phenols. In a randomized crossover clinical trial, subjects (n = 35: PreDM-IR, n = 25; healthy Reference group, n = 10) consumed 1 cup RRB (fresh weight equivalence) per day and RRB with 8 g FOS per day each for 4 weeks in random order separated by 4-week washout. Plasma and urinary (poly)phenolic metabolites were characterized after (0-24h) consuming a RRB-based test drink (2 cups RRB) at baseline/week 0 and again after 4-week supplementations. A total of 123 (poly)phenolic metabolites were quantified. After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids. Supplementing FOS with RRB for 4 weeks enhanced benzoic acid derivatives compared to the baseline ( p  < 0.05). Specific effects of supplementation by metabolic status indicated 4-week RRB supplementation significantly increased microbial metabolites that were lower in PreDM-IR group. Our results suggest alterations in the capacity of PreDM-IR group to metabolize and render bioavailable raspberry-derived (poly)phenols when consumed regularly.",2020,"After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids.","['adults with prediabetes and insulin-resistance (PreDM-IR', 'subjects (n = 35: PreDM-IR, n = 25; healthy Reference group, n = 10']","['4-Week Red Raspberry ( Rubus idaeus  L', '4-week RRB supplementation', 'RRB supplementation', 'consumed 1 cup RRB', 'Intake with or without Fructo-Oligosaccharide Supplementation']","['Plasma and urinary (poly)phenolic metabolites', 'Red raspberries (RRB', 'benzoic acid derivatives', 'Plasma and Urinary (Poly)phenolic Profiles', 'microbial metabolites', 'urolithins, phenyl-γ-valerolactones, and phenolic acids']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C1446808', 'cui_str': 'Rubus idaeus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0053225', 'cui_str': 'Benzoic acid'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0443441', 'cui_str': 'Valerolactone'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}]",123.0,0.020923,"After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids.","[{'ForeName': 'Xuhuiqun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Sandhu', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Britt M', 'Initials': 'BM', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25204777']
1313,33081069,"Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.","A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.",2020,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","['169 FM patients', 'patients with fibromyalgia']","['Multicomponent Treatment', 'exercise therapy (TE), cognitive behavioral therapy (CBT', 'multicomponent treatment (nature activity therapy', 'TAU + NAT-FM vs. TAU alone', 'TAU + NAT-FM']","['Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM', 'pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables', 'number needed to treat (NNT', 'affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy', 'usual (TAU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0150123', 'cui_str': 'Activity care'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",169.0,0.0817792,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Serrat', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Míriam', 'Initials': 'M', 'LastName': 'Almirall', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Musté', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Méndez-Ulrich', 'Affiliation': 'Research Group on Socioeducative Interventions in Childhood and Youth (GRISIJ), Department of Methods of Research and Diagnosis in Education, Faculty on Education, University of Barcelona, 08007 Barcelona, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Catalonia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sanz', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9103348']
1314,33081070,"Recruitment and Baseline Characteristics of Participants in the ""Sanadak"" Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress.","Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app ""Sanadak"" was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample ( n  = 170) and the trial sample ( n  = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were  M  = 32.8 (SD = 11.2, range = 18-65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany.",2020,"Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress.","['M  = 32.8 (SD = 11.2, range = 18-65) years old; 38.8% were women', 'Recruited individuals were']",[],"['Psychological distress', 'post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary', 'Anxiety', 'major depression', 'average PDS-5 score']","[{'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.14662,"Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Röhr', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Franziska U', 'Initials': 'FU', 'LastName': 'Jung', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plexnies', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17207578']
1315,33081083,A Rose Extract Protects the Skin against Stress Mediators: A Potential Role of Olfactory Receptors.,"Olfactory receptors (ORs) are expressed and active in various human tissues, including the skin. Although the sense of smell plays an important physiological role in the regulation of mood and stress, a link between olfactive compounds, ORs, and skin stress has yet to be established. This study aims to investigate the role of newly identified skin ORs and agonists in the modulation of skin stress. Screening for odorant molecules was done with cAMP functional assay to identify OR agonists. RT-qPCR and immunofluorescence microscopy were conducted to identify and quantify ORs in epidermal keratinocytes (NHEKs) and human skin explants, as well as to evaluate specific markers (G6PDH, loricrin, and γH2AX) of stress-induced skin alterations. A randomized double-blinded, split-face clinical study was performed on a panel of stressed women to measure the benefits of OR agonist treatment for skin. Three new ORs (OR10A6, OR2AG2, and OR11H4) were identified in skin. A specific Rose extract and its major constituent (phenylethyl alcohol) were found to activate these ORs. The extract composition was revealed by both GC/FID and GC/MS analyses simultaneously and showed the presence of 34 volatiles molecules. Moreover, epinephrine induces a skin stress response characterized by increased expression of G6PD, loricrin, and γH2AX biomarkers, and a decrease of OR expression. These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles. Altogether, our findings suggest that ORs may represent a new, promising way to treat stress-associated skin disorders.",2020,These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles.,[],['epinephrine'],"['appearance of under-eye dark circles', 'Skin against Stress Mediators', 'extract composition', 'skin stress response', 'OR expression', 'expression of G6PD, loricrin, and γH2AX biomarkers']",[],"[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0083258', 'cui_str': 'loricrin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0258105,These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles.,"[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Duroux', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, 31036 Toulouse CEDEX, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mandeau', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, 31036 Toulouse CEDEX, France.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Guiraudie-Capraz', 'Affiliation': 'Institute of Neurophysiopathology, CNRS, Aix-Marseille University, UMR 7051, CEDEX 15, F-13344 Marseille, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Quesnel', 'Affiliation': 'ChemCom S.A., B-1070 Brussels, Belgium.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Loing', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, Quebec, QC G1V 4M6, Canada.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25204743']
1316,33082342,A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics.,"Here, we randomized 53 patients hospitalized with coronavirus disease 2019 (COVID-19) to hydroxychloroquine therapy (at a dose of 400 mg twice daily for seven days) in addition to standard care or standard care alone (ClinicalTrials.gov Identifier, NCT04316377). All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission. Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days. Our results suggest no important antiviral effect of hydroxychloroquine in humans infected with SARS-CoV-2.",2020,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"['53 patients hospitalized with coronavirus disease 2019 (COVID-19) to', 'All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'coronavirus disease 2019 viral kinetics', 'positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission']","['hydroxychloroquine', 'hydroxychloroquine therapy (at a dose of 400\u2009mg twice daily for seven days) in addition to standard care or standard care alone']",['rate of decline in SARS-CoV-2 oropharyngeal viral load'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C5190549', 'cui_str': 'Hydroxychloroquine therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",53.0,0.292815,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Corina Silvia', 'Initials': 'CS', 'LastName': 'Rueegg', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Nature communications,['10.1038/s41467-020-19056-6']
1317,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1318,32682507,Heated fennel therapy promotes the recovery of gastrointestinal function in patients after complex abdominal surgery: A single-center prospective randomized controlled trial in China.,"BACKGROUND


Postoperative gastrointestinal dysfunction remains a major determinant of the duration of stay after complex abdominal surgery. This study was performed to evaluate the effectiveness of heated fennel therapy in accelerating the recovery of gastrointestinal function.
METHODS


This surgeon-blinded, prospective randomized controlled study included 381 patients with hepatobiliary, pancreatic, and gastric tumors who were divided into 2 groups. The patients in the experimental groups received heated fennel therapy, and those in the control groups received heated rice husk therapy. We compared the baseline characteristics, time to first postoperative flatus and defecation, fasting time, duration of postoperative hospital stay, grading of abdominal pain, classification of abdominal distension, inflammatory markers, and nutritional status indicators.
RESULTS


The time to first flatus and first defecation and the fasting time were statistically significantly less in the heated fennel therapy group than those in the control groups (P < .05 each); and abdominal distension was also relieved in the experimental groups (P < .001). Heated fennel therapy had no obvious beneficial effect on inflammatory markers but improved the serum albumin (ALB) level of the patients at postop day 9 (P < .001). Among the patients with alimentary tract reconstruction, those in the heated fennel therapy group had a clinically important, lesser hospital stay than those in the control group (9.2 5 ± 5.1 versus 11.1 ± 6.4; P < .023).
CONCLUSION


Heated fennel therapy facilitated the gastrointestinal motility function of patients early postoperatively.",2020,The time to first flatus and first defecation and the fasting time were statistically significantly less in the heated fennel therapy group than those in the control groups (P < .05 each); and abdominal distension was also relieved in the experimental groups (P < .001).,"['381 patients with hepatobiliary, pancreatic, and gastric tumors who were divided into 2 groups', 'patients after complex abdominal surgery']","['Heated fennel therapy', 'heated rice husk therapy', 'heated fennel therapy']","['time to first flatus and first defecation and the fasting time', 'gastrointestinal motility function', 'recovery of gastrointestinal function', 'abdominal distension', 'inflammatory markers', 'hospital stay', 'baseline characteristics, time to first postoperative flatus and defecation, fasting time, duration of postoperative hospital stay, grading of abdominal pain, classification of abdominal distension, inflammatory markers, and nutritional status indicators', 'serum albumin (ALB) level']","[{'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0015833', 'cui_str': 'Fennel extract'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",381.0,0.0272158,The time to first flatus and first defecation and the fasting time were statistically significantly less in the heated fennel therapy group than those in the control groups (P < .05 each); and abdominal distension was also relieved in the experimental groups (P < .001).,"[{'ForeName': 'Baiyang', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Yusha', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Deliang', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Pengpeng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Zhisu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Research Center of Digestive Diseases, Zhongnan Hospital of Wuhan University, Wuhan, PR China.'}, {'ForeName': 'Quanyan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, General Hospital of Tianjin Medical University, Tianjin, PR China. Electronic address: spsslqy@vip.126.com.'}]",Surgery,['10.1016/j.surg.2020.05.040']
1319,33066338,"Effect of a Short-Time Probiotic Supplementation on the Abundance of the Main Constituents of the Gut Microbiota of Term Newborns Delivered by Cesarean Section-A Randomized, Prospective, Controlled Clinical Trial.","The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of  L. rhamnosus  and  B. breve . The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of  L. rhamnosus  and  B. breve  enriched the gut microbiota composition with lactic acid bacteria.",2020,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"['In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study', 'newborns delivered by cesarean section (CS', 'newborns']","['probiotic supplement', 'Short-Time Probiotic Supplementation', 'cesarean section immediately after birth with a mixture of', 'probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group', 'L. rhamnosus  and  B']",['quick and abundant colonization'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}]",150.0,0.035509,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hurkala', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Radziszewska', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Strus', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Heczko', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}]",Nutrients,['10.3390/nu12103128']
1320,33066348,An Acute Application of Cerebellar Transcranial Direct Current Stimulation Does Not Improve Motor Performance in Parkinson's Disease.,"Transcranial direct current stimulation of the cerebellum (c-tDCS) improves motor performance in young and old adults. Based on the cerebellar involvement in Parkinson's disease (PD), c-tDCS could have potential to improve motor function in PD. The purpose was to determine the effects of c-tDCS on motor performance in PD while participants were on medications. The study was a randomized, double-blind, SHAM-controlled, between-subjects design. Twenty-two participants with PD were allocated to either a c-tDCS group or a SHAM group. All participants completed one experimental session and performed two motor tasks with their most affected hand in a Baseline condition (no stimulation) and an Experimental condition. The motor tasks were a visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT). The primary dependent variables were force error and endpoint error in the PGT and AMT, respectively. There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups. These results indicate that an acute application of c-tDCS does not enhance motor performance in hand and arm tasks in PD. Longer-term c-tDCS application over multiple days may be needed to enhance motor function in PD.",2020,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[""Parkinson's Disease"", 'Twenty-two participants with PD', 'young and old adults']","['SHAM', 'Transcranial direct current stimulation of the cerebellum (c-tDCS', 'c-tDCS', 'Cerebellar Transcranial Direct Current Stimulation']","['Motor Performance', 'visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT', 'force error and endpoint error', 'motor performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",22.0,0.189365,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[{'ForeName': 'Lidio', 'Initials': 'L', 'LastName': 'Lima de Albuquerque', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pantovic', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Clingo', 'Affiliation': 'School of Medicine, University of Nevada Las Vegas, Las Vegas, NV 89102, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Jalene', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mari', 'Affiliation': 'Movement Disorders Program, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV 89106, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}]",Brain sciences,['10.3390/brainsci10100735']
1321,33066469,Chemically Activated Cooling Vest's Effect on Cooling Rate Following Exercise-Induced Hyperthermia: A Randomized Counter-Balanced Crossover Study.,"Background and objectives:  Exertional heat stroke (EHS) is a potentially lethal, hyperthermic condition that warrants immediate cooling to optimize the patient outcome. The study aimed to examine if a portable cooling vest meets the established cooling criteria (0.15 °C·min -1  or greater) for EHS treatment. It was hypothesized that a cooling vest will not meet the established cooling criteria for EHS treatment.  Materials and Methods:  Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 . female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a motorized treadmill in a hot climatic chamber (ambient temperature 39.8 ± 1.9 °C, relative humidity 37.4 ± 6.9%) until they reached rectal temperature (T RE ) >39 °C (mean T RE , 39.59 ± 0.38 °C). Following exercise, participants were cooled using either a cooling vest (VEST) or passive rest (PASS) in the climatic chamber until T RE  reached 38.25 °C. Trials were assigned using randomized, counter-balanced crossover design.  Results:  There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02 °C·min -1 ) than PASS (0.04 ± 0.01 °C·min -1 ) (MD = 0.02, 95% CI = [0.01, 0.03]). There were also main effects of sex (F[1, 24] = 5.97,  p  = 0.02, η 2 p  = 0.20) and cooling modality type (F[1, 24] = 4.38,  p  = 0.047, η 2 p  = 0.15) on cooling duration, with a faster cooling time in female (26.9 min) than male participants (42.2 min) (MD = 15.3 min, 95% CI = [2.4, 28.2]) and faster cooling duration in VEST than PASS (MD = 13.1 min, 95% CI = [0.2, 26.0]). An increased body mass was associated with a decreased cooling rate in PASS (r = -0.580,  p  = 0.03); however, this association was not significant in vest (r = -0.252,  p  = 0.39).  Conclusions:  Although VEST exhibited a greater cooling capacity than PASS, VEST was far below an acceptable cooling rate for EHS treatment. VEST should not replace immediate whole-body cold-water immersion when EHS is suspected.",2020,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","['female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a', 'Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 ']","['VEST', '°C·min -1 ', 'cooling vest (VEST) or passive rest (PASS', 'Exercise-Induced Hyperthermia', 'motorized treadmill in a hot climatic chamber']","['cooling rate', 'cooling rates', 'faster cooling duration', 'cooling rate in PASS', 'Cooling Rate', 'faster cooling time in female', 'cooling capacity', 'cooling duration', 'body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517510', 'cui_str': '1.66'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444519', 'cui_str': 'Hot'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.144512,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Hosokawa', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama 359-1192, Japan.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX 75231, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Adams', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC 27412, USA.'}, {'ForeName': 'Lesley W', 'Initials': 'LW', 'LastName': 'Vandermark', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR 72701, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT 06269, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100539']
1322,33066554,The Impact of Time-Restricted Diet on Sleep and Metabolism in Obese Volunteers.,"Background and objectives:  A time-restricted diet is one of the various ways to improve metabolic condition and weight control. However, until now, there have been few pieces of evidence and research to verify the methods and effectiveness of time-restricted diets on metabolic improvement and health promoting. We designed this study to make a healthy diet program and to verify the effectiveness of a time-restricted diet on general health, including sleep and metabolism, in healthy volunteers.  Materials and Methods : This study was conducted in healthy adults who are obese but do not have related metabolic disease. Fifteen participants were recruited. Before and after this program, serologic tests including ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG) were conducted to evaluate the effects on sleep of the program. They were divided into two groups based on ketone levels that could reflect the constancy of participation in this study. We analyzed the before and after results of each group.  Results:  Fifteen participants (nine males and six females) completed this program without significant adverse events. Body weight after this program decreased to 78.2 ± 14.1 from 82.0 ± 15.6 kg ( p  = 0.539), and BMI decreased to 27.9 ± 3.8 from 29.3 ± 4.6 kg/m 2  ( p  = 0.233). Weight loss was observed in 14 subjects except 1 participant. The results from questionnaires before and after this were not significant changes. They were classified into high/low-ketone groups according to the ketone level of the participants. In the results of the PSG, the apnea hypopnea index (25.27 ± 12.67→15.11 ± 11.50/hr,  p  = 0.25) and oxygen desaturation (18.43 ± 12.79→10.69 ± 10.0/hr,  p  = 0.004), which are indicators of sleep apnea, also improved in the high-ketone group, compared with the low-ketone group. Satisfaction interviews for this restricted diet program showed that 86% of the participants were willing to participate in the same program again.  Conclusion:  The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep. In addition, successful weight loss and significant improvement of sleep apnea were showed in the high-ketone group. Further research is needed to demonstrate mechanisms for weight loss, sleep apnea, and time-restricted diets.",2020,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","['14 subjects except 1 participant', 'Fifteen participants (nine males and six females', 'healthy volunteers', 'healthy adults who are obese but do not have related metabolic disease', 'Fifteen participants were recruited', 'Obese Volunteers']","['healthy diet program', 'Materials and Methods ', 'Time-Restricted Diet', 'time-restricted diet']","['BMI', 'Sleep and Metabolism', 'weight loss', 'apnea hypopnea index', 'sleep apnea', 'oxygen desaturation', 'successful weight loss', 'efficiency and architecture of sleep', 'ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG', 'Weight loss', 'Body weight']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",15.0,0.0125746,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","[{'ForeName': 'Hyeyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Bong Jin', 'Initials': 'BJ', 'LastName': 'Jang', 'Affiliation': 'Department of Medical Business Administration, Daegu Hanny University, Gyeongsangbuk-Do 38610, Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Jung', 'Affiliation': ""Department of Nutrition Management, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Jayoung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Department of Laboratory Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': 'The Convergence Institute of Healthcare and Medical Science, College of Medicine, Catholic Kwandong University, Incheon 22711, Korea.'}, {'ForeName': 'Yeong In', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100540']
1323,33066593,Exercise Intensity May Not Moderate the Acute Effects of Functional Circuit Training on Cognitive Function: A Randomized Crossover Trial.,"Functional circuit training (FCT) has been demonstrated to acutely enhance cognitive performance (CP). However, the moderators of this observation are unknown. This study aimed to elucidate the role of exercise intensity. According to an a priori sample size calculation,  n  = 24 healthy participants (26 ± 3 years, 13 females), in randomized order, performed a single 15-min bout of FCT with low (20-39% of the heart rate reserve/HRR), moderate (40-59% HRR) or high intensity (maximal effort). Immediately pre- and post-workout, CP was measured by use of the Digit Span test, Stroop test and Trail Making test. Non-parametric data analyses did not reveal significant differences between conditions ( p  > 0.05) although parameter-free 95% confidence intervals showed pre-post improvements in some outcomes at moderate and high intensity only. The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.",2020,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"['24 healthy participants (26 ± 3 years, 13 females', 'young active adults']","['Functional Circuit Training', 'Functional circuit training (FCT']",['Cognitive Function'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",24.0,0.0300091,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Royé', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100738']
1324,33068770,Benefits of using a simulator in the initial training for transvaginal ultrasound examination in gynecologic emergency unit.,"PURPOSE


Transvaginal ultrasound examination is decisive in Gynecologic emergency unit. This study's aim was to evaluate benefits of using a simulator for initial training of medical student for transvaginal ultrasound examination.
METHOD


A multicenter randomized trial was conducted. Medical student were randomized in two groups: in the intervention group, students took part in a simulation session in addition to the companionship-training while in the control group, they were only trained by companionship. To evaluate their progression, the quality of ultrasound pictures performed in real conditions before (pre-test) and after (post-test) the training by the students of both groups were evaluated and compared. Evaluation was performed according to predefined quality criterias for each ultrasound examination using a score of 20 points. Mean scores of students in both groups were compared for the pre and post-test.
RESULTS


Fifty six medical students were included. Mean scores of the 56 students were significantly better at the post-test than at the pre-test: 10,61/20 [9,62-11, 59] vs 6,35/20 [5,48-7,24], p < 0,001. Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20 [7,72-10,94] vs 9,33/20 [7,72-10,94], p = 0,01. All the students in the intervention group were satisfied or highly satisfied to take part in this program.
CONCLUSIONS


Using a simulator for medical student was beneficial in the initial training of transvaginal ultrasound examination.",2020,"Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20","['Gynecologic emergency unit', 'six medical students were included', 'Fifty', 'gynecologic emergency unit']","['students took part in a simulation session in addition to the companionship-training while in the control group, they were only trained by companionship', 'Transvaginal ultrasound examination']",['Mean scores'],"[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",56.0,0.0271445,"Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Etienne', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Faculty of Medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Gabay', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Levaillant', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Vivanti', 'Affiliation': 'Department of Obstetrics and Gynecology, Hopital Antoine Bécère, GHU Sud, AP-HP, 92140, Clamart, France; Faculty of Medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dommergues', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Pitié-Salpêtrière, AP-HP, 75013, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Fernandez', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Inserm, Centre of Research in Epidemiology and Population Health (CESP), U1018, F-94276, Le Kremlin Bicêtre, France; Faculty of Medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Capmas', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Inserm, Centre of Research in Epidemiology and Population Health (CESP), U1018, F-94276, Le Kremlin Bicêtre, France; Faculty of Medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France. Electronic address: perrine.capmas@aphp.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101938']
1325,33068901,"Facilitating Activity and Self-management for people with Arthritic knee, hip or lower back pain (FASA): A cluster randomised controlled trial.","BACKGROUND


Chronic musculoskeletal pain including osteoarthritis (OA) can significantly limit the functional independence of individuals. The spine and hip and knee are predominantly affected; management guidelines for each recommend exercise and education to support self-management.
OBJECTIVES


This study investigated the effectiveness of a generic exercise and self-management intervention for people over-50 with hip/knee OA and/or lower back pain compared to continued GP management.
DESIGN


Single blind, cluster randomised controlled trial.
METHOD


Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45 GP practices in SW England. Practices were randomly allocated to receive continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department. The primary outcome measure was the Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA) measured at six month post-rehabilitation.
RESULTS


349 participants were recruited and allocated to the intervention (n = 170) or control (n = 179) arms; the attrition rate was 13% at the 6 month primary end-point. One minor adverse event in the intervention group that required no medical input was reported. Intervention arm participants reported better function at 6 months compared with continued GP management alone (-3.01 difference in DI-SMFA [95%CI -5.25, -0.76], p = 0.01).
CONCLUSIONS


A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear. This may be an effective way of managing group interventions for lower limb OA and chronic lower back pain.",2020,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","['people with Arthritic knee, hip or lower back pain (FASA', 'people over-50 with hip/knee OA and/or lower back pain', '349 participants', 'Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45\xa0GP practices in SW England', 'Chronic musculoskeletal pain including osteoarthritis (OA']","['generic exercise and self-management intervention', 'continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department', 'continued GP management alone']","['Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA', 'attrition rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",349.0,0.105192,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK. Electronic address: Nicola.walsh@uwe.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': ""Lang'o"", 'Initials': 'L', 'LastName': 'Odondi', 'Affiliation': 'Division of Cardiovascular Medicine, University of Nottingham, UK.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': ""Faculty for Health, Social Care and Education. St George's University of London & Kingston University, UK.""}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102271']
1326,33070009,A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.,"INTRODUCTION


In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.
METHODS


Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.
RESULTS


A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
CONCLUSION


Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.",2020,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[""Parkinson's disease"", 'Individuals with PD and clinically significant anxiety', 'mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic', 'A total of 21 participants enrolled, 4 were randomized to']","['flexible dosage buspirone or placebo', 'placebo', 'buspirone']","['Parkinson Anxiety Scale', 'adverse events', 'tolerability', 'Hamilton Anxiety Rating Scale', 'adverse events, dosage reductions, motor function, dyskinesias, and anxiety']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",21.0,0.0671081,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[{'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: ruth_schneider@urmc.rochester.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health and Technology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box 694, Rochester, NY, USA. Electronic address: peggy.auinger@chet.rochester.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: christopher_tarolli@urmc.rochester.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Iourinets', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: jiourine@u.rochester.edu.'}, {'ForeName': 'María Cristina', 'Initials': 'MC', 'LastName': 'Gil-Díaz', 'Affiliation': 'Department of Neuroscience, University of Rochester, 500 Joseph C. Wilson Blvd, Rochester, NY, 14627, USA. Electronic address: mgildiaz@u.rochester.edu.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: irene_richard@urmc.rochester.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.020']
1327,33070045,Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.,"OBJECTIVE


Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors.
METHODS


Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data.
RESULTS


Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels.
CONCLUSION


Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.",2020,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","['Seventy-seven participants', 'cancer survivors', 'Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue', 'fatigued cancer survivors']","['light therapy intervention', 'bright white light (BWL) or dim red light (DRL) device']","['diurnal cortisol slopes nor total cortisol output', 'Diurnal cortisol slopes and total cortisol output', 'total cortisol output', 'steepness in cortisol slope', 'fatigue and salivary cortisol', 'diurnal salivary cortisol', 'diurnal cortisol slopes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",77.0,0.241495,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","[{'ForeName': 'Jillian A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, State College, PA, USA. Electronic address: jaj53@psu.edu.'}, {'ForeName': 'Utkarsh', 'Initials': 'U', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: utkarsh.subnis@ucalgary.ca.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: lcarlso@ucalgary.ca.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University, St. John's, Newfoundland, Canada. Electronic address: sheila.garland@mun.ca.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Santos-Iglesias', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada. Electronic address: pablo_santos@cbu.ca.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: klpiedal@ucalgary.ca.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Deleemans', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Division of Medical Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: julie.deleemans@ucalgary.ca.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110266']
1328,33070053,"Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL).","OBJECTIVES


Progression-free survival (PFS) and response rate to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) varies in patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations, suggesting that other genetic alterations may influence oncogene addiction. Low BRCA1 mRNA levels correlate with longer PFS in erlotinib-treated EGFR-mutant NSCLC patients. Since the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, may attenuate and/or prevent BRCA1 expression, the addition of olaparib to gefitinib could improve outcome in EGFR-mutant advanced NSCLC.
MATERIALS AND METHODS


GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.
RESULTS


Between September 2013, and July 2016, 182 patients underwent randomization, 91 received gefitinib and 91 received gefitinib plus olaparib. There were no differences in gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation. Median PFS was 10.9 months (95 % CI 9.3-13.3) in the gefitinib arm and 12.8 months (95 % CI 9.1-14.7) in the gefitinib plus olaparib arm (HR 1.38, 95 % CI 1.00-1.92; p = 0.124). The most common adverse events were anemia, 78 % in gefitinib plus olaparib group, 38 % in gefitinib arm, diarrhea, 65 % and 60 %, and fatigue, 40 % and 32 %, respectively.
CONCLUSIONS


The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.",2020,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","['182 patients underwent randomization, 91 received', 'Between September 2013, and July 2016', 'patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations', 'two countries, Spain and Mexico', 'EGFR mutant non-small-cell lung cancer (NSCLC', 'Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease']","['gefitinib 250\u202fmg daily or gefitinib 250\u202fmg daily plus olaparib 200\u202fmg three times daily in 28-day cycles', 'epidermal growth factor receptor', 'EGFR) tyrosine kinase inhibitors (TKIs', 'gefitinib', 'gefitinib plus olaparib', 'gefitinib and olaparib versus gefitinib alone']","['diarrhea', 'Median PFS', 'hematological and gastrointestinal toxicity', 'PFS', 'overall survival (OS), response rate, safety and tolerability', 'gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",182.0,0.184564,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Campelo', 'Affiliation': 'University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ana Laura Ortega', 'Initials': 'ALO', 'LastName': 'Granados', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': 'Hospital de Mataró, Mataró, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute (IDIBGi), Girona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ""Hospital Clínic Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guirado', 'Affiliation': 'Hospital General de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vázquez-Estevez', 'Affiliation': 'Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Reyes Bernabé', 'Initials': 'RB', 'LastName': 'Caro', 'Affiliation': 'Hospital Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Verdú', 'Affiliation': 'Spanish Lung Cancer Group Office, Barcelona, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Molina-Vila', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.018']
1329,33070057,Salivary measurement and mindfulness-based modulation of prescription opioid cue-reactivity.,"BACKGROUND


Chronic pain patients on long-term opioid therapy (LTOT) may be at elevated risk for developing conditioned opioid cue-reactivity as their prescribed dosing schedules simultaneously function as fixed reinforcement schedules. Since opioids are typically consumed orally during LTOT, it stands to reason that opioid cue exposure might elicit conditioned salivary responses. However, no study has examined salivary cue-reactivity among opioid users during in-vivo exposure to their own prescription opioid medication.
METHODS


Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics. Study 1 aimed to determine whether chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid. Study 2 was a pilot study that aimed to assess the effects of behavioral treatment on chronic pain patients' salivary cue-reactivity.
RESULTS


In Study 1, exposure to the patient's own prescribed opioid resulted in significantly greater increases in salivation and cue-elicited craving than exposure to a neutral cue. In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
CONCLUSIONS


Study findings demonstrate salivation may serve as a useful, objective index of opioid cue-reactivity. With further refinement of this task, conditioned salivary response could be used to identify especially vulnerable patients, who then could be targeted with a personalized medicine approach for selective and intensive prevention/treatment interventions to preempt escalation of opioid use to opioid misuse and OUD.",2020,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","['chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid', 'Chronic pain patients on long-term', ""chronic pain patients' salivary cue-reactivity"", 'Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics']","['8-week Mindfulness-Oriented Recovery Enhancement intervention', 'behavioral treatment', 'opioid therapy (LTOT']","['salivation and cue-elicited craving', 'opioid cue-reactivity', 'salivation and craving ratings']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",2.0,0.0378235,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States; Salt Lake City Veterans Administration Medical Center, United States. Electronic address: eric.garland@socwk.utah.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108351']
1330,33085861,Anti-Siglec-8 Antibody for Eosinophilic Gastritis and Duodenitis.,"BACKGROUND


Eosinophilic gastritis and duodenitis are characterized by gastrointestinal mucosal eosinophilia, chronic symptoms, impaired quality of life, and a lack of adequate treatments. Mast-cell activity may contribute to the pathogenesis of the conditions. AK002 (lirentelimab) is an anti-Siglec-8 antibody that depletes eosinophils and inhibits mast cells and that has shown potential in animal models as a treatment for eosinophilic gastritis and duodenitis.
METHODS


In this phase 2 trial, we randomly assigned adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of low-dose AK002, high-dose AK002, or placebo. The primary end point was the change in gastrointestinal eosinophil count from baseline to 2 weeks after the final dose; to maximize statistical power, we evaluated this end point in the placebo group as compared with the combined AK002 group. Secondary end points were treatment response (>30% reduction in total symptom score and >75% reduction in gastrointestinal eosinophil count) and the change in total symptom score.
RESULTS


Of the 65 patients who underwent randomization, 43 were assigned to receive AK002 and 22 were assigned to receive placebo. The mean percentage change in gastrointestinal eosinophil count was -86% in the combined AK002 group, as compared with 9% in the placebo group (least-squares mean difference, -98 percentage points; 95% confidence interval [CI], -121 to -76; P<0.001). Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001). The mean change in total symptom score was -48% with AK002 and -22% with placebo (least-squares mean difference, -26 percentage points; 95% CI, -44 to -9; P = 0.004). Adverse events associated with AK002 were similar to those with placebo, with the exception of higher percentages of patients having mild-to-moderate infusion-related reactions with AK002 (60% in the combined AK002 group and 23% in the placebo group).
CONCLUSIONS


In patients with eosinophilic gastritis or duodenitis, AK002 reduced gastrointestinal eosinophils and symptoms. Infusion-related reactions were more common with AK002 than with placebo. (Funded by Allakos; ENIGMA ClinicalTrials.gov number, NCT03496571.).",2020,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","['adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of', '65 patients who underwent randomization']","['placebo', 'low-dose AK002, high-dose AK002, or placebo']","['gastrointestinal eosinophil count', 'total symptom score', 'gastrointestinal eosinophils and symptoms', 'mean change in total symptom score', 'change in gastrointestinal eosinophil count', 'Treatment response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0267154', 'cui_str': 'Eosinophilic gastritis'}, {'cui': 'C4305493', 'cui_str': 'Eosinophilic duodenitis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.46767,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Peterson', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Gonsalves', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Chehade', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Paneez', 'Initials': 'P', 'LastName': 'Khoury', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Hazan', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Bledsoe', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sandy R', 'Initials': 'SR', 'LastName': 'Durrani', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Chang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amol P', 'Initials': 'AP', 'LastName': 'Kamboj', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Rasmussen', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2012047']
1331,33086438,Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy.,"BACKGROUND


The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220.
AIMS


To assess efficacy (through week 92) and safety (through week 96) during the long-term extension METHODS: Overall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long-term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44. Partial Mayo scores were collected every 12 weeks and at each dosing visit after unblinding. Safety was evaluated throughout.
RESULTS


Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. Among randomised patients treated in the long-term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid-free. Both ustekinumab groups maintained efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred patient-years (PY) of follow-up for combined ustekinumab vs placebo were: 255.68 vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non-melanoma skin cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with multiple comorbidities who received one ustekinumab dose after dose adjusting from placebo experienced a fatal cardiac arrest.
CONCLUSIONS


The efficacy of ustekinumab in patients with UC was sustained through 92 weeks. No new safety signals were observed (ClinicalTrials.gov number, NCT02407236).",2020,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","['moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220', 'patients with UC']","['subcutaneous placebo', 'Ustekinumab', 'ustekinumab', 'placebo', 'ustekinumab 90\xa0mg every 12\xa0weeks [q12w], and 143 received ustekinumab 90\xa0mg q8w', 'Placebo']","['Safety', 'serious infections', 'Partial Mayo scores', 'symptomatic remission rates', 'fatal cardiac arrest', 'new safety signals', 'symptomatic remission']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.361164,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Calgary, AB, Canada.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'La Jolla, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Targan', 'Affiliation': 'Los Angeles, CA, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Miami, FL, USA.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Scherl', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Concord, NSW, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rowbotham', 'Affiliation': 'Auckland, New Zealand.'}, {'ForeName': 'Ramesh P', 'Initials': 'RP', 'LastName': 'Arasaradnam', 'Affiliation': 'Coventry, UK.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Spring House, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16119']
1332,33086512,Use of Metabolomic Profiling to Understand Variability in Adiposity Changes Following an Intentional Weight Loss Intervention in Older Adults.,"Inter-individual response to dietary interventions remains a major challenge to successful weight loss among older adults. This study applied metabolomics technology to identify small molecule signatures associated with a loss of fat mass and overall weight in a cohort of older adults on a nutritionally complete, high-protein diet. A total of 102 unique metabolites were measured using liquid chromatography-mass spectrometry (LC-MS) for 38 adults aged 65-80 years randomized to dietary intervention and 36 controls. Metabolite values were analyzed in both baseline plasma samples and samples collected following the six-month dietary intervention to consider both metabolites that could predict the response to diet and those that changed in response to diet or weight loss.Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate. Within the intervention group, there was broad variation in the achieved weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass. Change in the VAT mass was significantly associated with the baseline abundance of α-aminoadipate ( p  = 0.0007) and an additional mass spectrometry peak that may represent D-fructose, myo-inositol, mannose, α-D-glucose, allose, D-galactose, D-tagatose, or L-sorbose ( p  = 0.0001). This hypothesis-generating study reflects the potential of metabolomic biomarkers for the development of personalized dietary interventions.",2020,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","['older adults', '38 adults aged 65-80 years randomized to', 'Older Adults']","['liquid chromatography-mass spectrometry (LC-MS', 'Intentional Weight Loss Intervention', 'dietary intervention']","['weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass', 'Metabolite values']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",38.0,0.03014,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Quillen', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': ""O'Brien Cox"", 'Affiliation': 'Proteomics and Metabolomics Shared Resource, Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Furdui', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Hanzhi', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, USA.'}]",Nutrients,['10.3390/nu12103188']
1333,33066723,"Exploratory cross-over, trial of augmented RLS with the dopamine receptor 1/5 antagonist ecopipam D1/D5 antagonist ecopipam for augmented RLS.","BACKGROUND


Restless legs syndrome (RLS) is a common condition that initially responds dramatically to dopaminergic therapy. Over time, however, dopaminergics cause augmentation, where symptoms occur earlier and intensify. Animal models suggest this may result from increased dopamine receptor type-1 affinity in the spinal cord. Ecopipam is a potent, specific dopamine-1/5 receptor antagonist.
METHODS


We performed a small ( N  = 10) exploratory placebo controlled, cross-over safety trial of ecopipam (25-100 mg/day) for patients with augmented RLS currently taking dopamine agonists.
RESULTS


Ecopipam was well tolerated with sedation being the most common adverse event in drug and placebo. Safety scales and serology data were similar to placebo. The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug. No subject worsened on drug or demonstrated rebound worsening after drug discontinuation.
CONCLUSION


Ecopipam was safe and well tolerated in this initial study for RLS. Given the lack of alternate options, larger efficacy studies for augmented RLS, and potentially de novo RLS are justified.",2020,"The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug .",['patients with augmented restless legs syndrome currently taking'],"['dopamine agonists', 'Ecopipam', 'placebo', 'ecopipam']","['RLS diaries, the international RLS rating scale, and clinical global impressions', 'safe and well tolerated', 'Safety scales and serology data']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C1099053', 'cui_str': 'ecopipam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}]",,0.186238,"The study was not powered to demonstrate efficacy and exploratory efficacy data showed no significant improvement compared to placebo, but RLS diaries, the international RLS rating scale, and clinical global impressions all favored drug .","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Ondo', 'Affiliation': 'Methodist Neurological Institute, University of Texas, Houston, TX, USA.'}, {'ForeName': 'Titilayo', 'Initials': 'T', 'LastName': 'Olubajo', 'Affiliation': 'Methodist Neurological Institute, University of Texas, Houston, TX, USA.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1838515']
1334,33073879,"Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients With Motor Fluctuations.","OBJECTIVES


This placebo-controlled, randomized study evaluated the efficacy and safety of opicapone 25-mg and 50-mg tablets in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations.
METHODS


Japanese adults (n = 437, age 39-83 years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria) received opicapone 25-mg (n = 145), opicapone 50-mg (n = 145), or placebo (n = 147) tablets over the double-blind treatment period (14-15 weeks). The primary efficacy assessment was change in OFF-time; secondary efficacy assessments included OFF/ON-time responders (≥1 hour change from baseline), total ON-time, ON-time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale.
RESULTS


The least squares mean (standard error) change in OFF-time from baseline to the last visit was -0.42 (0.21) hour for the placebo group, -1.16 (0.22) hour for the opicapone 25 mg group, and -1.04 (0.21) hour for the opicapone 50 mg group. The percentage of ON-time responders, changes in total ON-time/ON-time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II (at OFF) all showed statistically significant improvements versus placebo for both opicapone tablet doses (P < 0.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05). Adverse events were more common in patients treated with opicapone 25 mg (60.0%) or opicapone 50 mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25 mg, 9.0%; opicapone 50 mg, 12.4%).
CONCLUSIONS


In Japanese patients, both opicapone 25 and 50 mg were significantly more effective than placebo with no dose-dependent difference in efficacy, and both doses were well tolerated. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC. on behalf of International Parkinson and Movement Disorder Society.",2020,Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05).,"[""Japanese adults (n = 437, age 39-83\u2009years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria"", ""Japanese Parkinson's Patients With Motor Fluctuations"", ""Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations""]","['opicapone 25-mg and 50-mg tablets', 'opicapone', 'placebo', 'Opicapone', 'opicapone 25-mg (n\u2009=\u2009145), opicapone 50-mg']","[""Unified Parkinson's Disease Rating Scale III (at ON"", 'efficacy and safety', 'Adverse events', ""OFF-time; secondary efficacy assessments included OFF/ON-time responders (≥1\u2009hour change from baseline), total ON-time, ON-time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale"", ""percentage of ON-time responders, changes in total ON-time/ON-time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II"", 'tolerated', 'least squares mean (standard error) change in OFF-time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2933912', 'cui_str': 'opicapone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.128247,Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05).,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'National Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Shiwa, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28322']
1335,33069664,Wide awake at bedtime? Effects of caffeine on sleep and circadian timing in male adolescents - A randomized crossover trial.,"Adolescents often suffer from short and mistimed sleep. To counteract the resulting daytime sleepiness they frequently consume caffeine. However, caffeine intake may exaggerate sleep problems by disturbing sleep and circadian timing. In a 28-hour double-blind randomized crossover study, we investigated to what extent caffeine disturbs slow-wave sleep (SWS) and delays circadian timing in teenagers. Following a 6-day ambulatory phase of caffeine abstinence and fixed sleep-wake cycles, 18 male teenagers (14-17 years old) ingested 80 mg caffeine vs. placebo in the laboratory four hours prior to an electro-encephalographically (EEG) recorded nighttime sleep episode. Data were analyzed using both frequentist and Bayesian statistics. The analyses suggest that subjective sleepiness is reduced after caffeine compared to placebo. However, we did not observe a strong caffeine-induced reduction in subjective sleep quality or SWS, but rather a high inter-individual variability in caffeine-induced SWS changes. Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine. Regarding salivary melatonin onsets, caffeine-induced delays were not evident at group level, and only observed in participants exposed to a higher caffeine dose relative to individual bodyweight (i.e., a dose > 1.3 mg/kg). Together, the results suggest that 80 mg caffeine are sufficient to induce alertness at a subjective level. However, particularly teenagers with a strong need for deep sleep might pay for these subjective benefits by a loss of SWS during the night. Thus, caffeine-induced sleep-disruptions might change along with the maturation of sleep need.",2020,Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine.,"['male adolescents', 'Adolescents often suffer from short and mistimed sleep', '18 male teenagers (14-17 years old', 'teenagers']","['caffeine abstinence and fixed sleep-wake-cycles', 'caffeine', 'ingested 80 mg caffeine vs. placebo', 'caffeine disturbs slow-wave sleep (SWS', 'placebo']","['subjective sleep quality', 'daytime sleepiness', 'sleep and circadian timing', 'subjective sleepiness']","[{'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.0515205,Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine.,"[{'ForeName': 'Carolin F', 'Initials': 'CF', 'LastName': 'Reichert', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland. Electronic address: carolin.reichert@upk.ch.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veitz', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bühler', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'The Siesta Group, Vienna, Austria.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Deuring', 'Affiliation': 'Department of Forensic Psychiatry, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sophia S', 'Initials': 'SS', 'LastName': 'Rehm', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Garbazza', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Clinical Sleep Laboratory, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Slawik', 'Affiliation': 'Clinical Sleep Laboratory, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Yu-Shiuan', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland; Neuropsychiatry and Brain Imaging, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Weibel', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}]",Biochemical pharmacology,['10.1016/j.bcp.2020.114283']
1336,33069888,Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC.,"INTRODUCTION


In cohort G of KEYNOTE-021 (NCT02039674), first-line pembrolizumab plus pemetrexed-carboplatin significantly improved the objective response rate and progression-free survival versus chemotherapy alone with manageable toxicity in advanced nonsquamous NSCLC. We report the long-term outcomes from this study.
METHODS


Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR or ALK alterations were randomly assigned 1:1 to receive open-label pemetrexed 500 mg/m 2  plus carboplatin at area under the concentration-time curve of 5 mg/mL/min (four cycles) with or without pembrolizumab 200 mg (up to 2 years), with optional pemetrexed maintenance, each administered every 3 weeks. Eligible patients could crossover from the chemotherapy arm to pembrolizumab monotherapy after progression. Responses were assessed per the Response Evaluation Criteria in Solid Tumors version 1.1.
RESULTS


After the median time of 49.4 months from randomization to data cutoff, objective response rate (58% versus 33%) and progression-free survival (median: 24.5 versus 9.9 mo; hazard ratio: 0.54; 95% confidence interval: 0.35‒0.83) remained improved with pembrolizumab combination (n = 60) versus chemotherapy (n = 63), regardless of programmed death ligand 1 status. Median overall survival was 34.5 versus 21.1 months (hazard ratio: 0.71; 95% confidence interval: 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒programmed death (ligand) 1 therapy. Among the 12 patients who completed 2 years of pembrolizumab, 92% were alive at data cutoff; the estimated 3-year duration of response rate was 100%. Grade 3 to 5 treatment-related adverse events occurred in 39% of patients receiving pembrolizumab combination and 31% receiving chemotherapy.
CONCLUSIONS


First-line pembrolizumab plus pemetrexed-carboplatin continued to show improved response and survival versus chemotherapy alone in advanced nonsquamous NSCLC, with durable clinical benefit in patients who completed 2 years of therapy. No new safety signals were observed with longer follow-up.",2020,"Median OS was 34.5 versus 21.1 months (HR, 0.71; 95%CI, 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒PD-(L)1 therapy.","['advanced nonsquamous non‒small-cell lung cancer (NSCLC', 'Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR/ALK alterations', 'Advanced Nonsquamous Non-Small-Cell Lung Cancer']","['pembrolizumab combination', 'pembrolizumab', 'pembrolizumab plus pemetrexed-carboplatin', 'open-label pemetrexed 500 mg/m 2  plus carboplatin AUC 5 mg/mL/min (4 cycles) with or without pembrolizumab', 'pembrolizumab monotherapy', 'Pemetrexed and Carboplatin With or Without Pembrolizumab', 'chemotherapy']","['response and survival', 'adverse events', 'PFS', 'Median OS', '3-year DOR rate', 'objective response rate (ORR) and progression-free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.218764,"Median OS was 34.5 versus 21.1 months (HR, 0.71; 95%CI, 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒PD-(L)1 therapy.","[{'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mark_awad@dfci.harvard.edu.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Thoracic Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Patnaik', 'Affiliation': 'Clinical Research, START Center for Cancer Care, San Antonio, Texas.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Republic of China.'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Powell', 'Affiliation': 'Oncology, Sanford Health, Sioux Falls, South Dakota.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Gentzler', 'Affiliation': 'Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, Virginia.'}, {'ForeName': 'Renato G', 'Initials': 'RG', 'LastName': 'Martins', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Stevenson', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Thoracic/Head and Neck Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shadia I', 'Initials': 'SI', 'LastName': 'Jalal', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Panwalkar', 'Affiliation': 'Hematology/Oncology, Sanford Roger Maris Cancer Center, Fargo, North Dakota.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gubens', 'Affiliation': 'Medical Oncology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lecia V', 'Initials': 'LV', 'LastName': 'Sequist', 'Affiliation': 'Hematology/Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Saraf', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.09.015']
1337,33069970,Labor neuraxial analgesia and breastfeeding: An updated systematic review.,"INTRODUCTION


There have been numerous reports studying the effect of neuraxial analgesia on breastfeeding success, but the results are inconsistent.
METHODS


We performed a literature search in various databases for studies comparing neuraxial analgesia to non-neuraxial or no analgesia. Outcomes were the percentage of women breastfeeding fully or mixed with formula. Where possible, nulliparous parturients were analyzed separately. We conducted an analysis excluding studies of serious and critical risk of bias. Odds ratios and 95% confidence intervals were calculated.
RESULTS


We included 15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants. Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results). In nulliparous only studies, 2 found no difference between study groups, 1 found a lower breastfeeding rate in the neuraxial group and 3 studies showed mixed results. Excluding studies with a serious and critical risk of bias, 1 study found no difference between study groups, 3 studies found a decrease of breastfeeding rates in the neuraxial group, and 1 study showed mixed results.
DISCUSSION


In our review we found a high disparity in results. One reason is probably the high potential of confounding (immediate skin to skin placement, maternity leave etc.). Education programs and breastfeeding support are likely more important in determining long term breastfeeding success.",2020,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","['nulliparous parturients', '15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants']",['Labor neuraxial analgesia and breastfeeding'],"['breastfeeding rates', 'incidence of breastfeeding', 'breastfeeding rate']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16112.0,0.0676764,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Heesen', 'Affiliation': 'Faculty of Medicine, University of Zurich, Winterthurerstrasse 190, 8057 Zurich, Switzerland. Electronic address: heesenphilip99@gmail.com.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Halpern', 'Affiliation': 'Department of Anesthesia, University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. Electronic address: stephen.halpern@sunnybrook.ca.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Beilin', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, and Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, New York, NY 10029, USA. Electronic address: yaakov.beilin@mountsinai.org.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Mauri', 'Affiliation': ""School of Midwifery, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via della Commenda 19, 20122 Milano, Italy; Department of Mother Child and Newborn Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. Electronic address: paola.mauri@unimi.it.""}, {'ForeName': 'Leonid A', 'Initials': 'LA', 'LastName': 'Eidelman', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: leidelman@clalit.org.il.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesia, Kantonsspital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: michael.heesen@ksb.ch.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Orbach-Zinger', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: sharonorbach@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110105']
1338,33069972,Efficacy of prothrombin complex concentrate for reversal of major bleeding due to rivaroxaban: A pilot randomized controlled trial.,,2020,,[],"['rivaroxaban', 'prothrombin complex concentrate']",[],[],"[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}]",[],,0.158675,,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Sadaghi', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishekar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: amahmoodpoor@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110093']
1339,33076981,What are the effects of supporting early parenting by newborn behavioral observations (NBO)? A cluster randomised trial.,"BACKGROUND


Professional support to enhance the early parent-infant relationship in the first months after birth is recommended, but little is known about the effect of universal interventions. The objective was to investigate the effect of health visitors' use of the Newborn Behavioral Observations system in new families.
METHODS


A cluster-randomised study was conducted in four Danish municipalities. Health visitors' geographical districts constituted the units for randomisation (n = 17). In the intervention group, 1332 families received NBO from 3 weeks after birth; in the comparison group, 1234 received usual care. Self-administered questionnaires were collected at baseline one to two weeks after birth, and at follow-up three and nine months postpartum. The outcomes were change over time measured by The Karitane Parenting Confidence Scale (KPCS), The Major Depression Inventory (MDI), The Ages and Stages Questionnaire: social-emotional (ASQ:SE) and The Mother and Baby Interaction Scale (MABIC). Data were analysed with mixed-effects linear regression using the intention-to-treat approach.
RESULTS


At baseline, no significant differences between the two groups were seen regarding maternal and infant factors. At follow-up three and nine months after birth, the change in maternal confidence and mood, infant's socio-emotional behaviour, and early parent-infant relationship moved in a slightly more positive direction in the intervention group than in the comparison group, though not statistically significant. The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
CONCLUSIONS


We found no effect of the NBO system delivered in a universal context to all families in a community setting. The only significant difference between groups was a higher maternal degree of knowledge regarding early parenting in the intervention group.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03070652 . Registrated February 22, 2017.",2020,"The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
","['A cluster-randomised study was conducted in four Danish municipalities', 'new families', ""Health visitors' geographical districts constituted the units for randomisation (n\u2009=\u200917""]","['NBO', 'Newborn Behavioral Observations system']","['maternal degree of knowledge regarding early parenting', ""maternal confidence and mood, infant's socio-emotional behaviour"", 'change over time measured by The Karitane Parenting Confidence Scale (KPCS), The Major Depression Inventory (MDI), The Ages and Stages Questionnaire: social-emotional (ASQ:SE) and The Mother and Baby Interaction Scale (MABIC', ""higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant""]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0410422', 'cui_str': 'Chronic multifocal osteomyelitis'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0825297,"The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
","[{'ForeName': 'Ingeborg Hedegaard', 'Initials': 'IH', 'LastName': 'Kristensen', 'Affiliation': 'Nursing and Health Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. Ihk@ph.au.dk.'}, {'ForeName': 'Svend', 'Initials': 'S', 'LastName': 'Juul', 'Affiliation': 'Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Nursing and Health Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.'}]",BMC psychology,['10.1186/s40359-020-00467-5']
1340,33075444,Fostering infant food texture acceptance: A pilot intervention promoting food texture introduction between 8 and 15 months.,"Healthy infant feeding practices form the basis of healthy eating behaviour later in life. The effect of providing parents with recommendations on textured food introduction between 8 and 15 months on children's experience with and acceptance of textured foods was studied. Sixty parent/child dyads were randomly assigned to a control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction. After the intervention, parents completed self-report measures about the introduction of 188 food items, including purees, soft/small pieces, hard/large pieces and double textures. Children's acceptance of eight textured foods was assessed in a laboratory setting. Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15). There was no group difference in children acceptance for any of the textured foods offered in the laboratory. Independent of their study group, children's exposure to texture was associated with birth order, self-feeding with fingers, low gagging frequency and seldom use of commercial baby foods. Higher acceptance was associated with higher exposure to food pieces but not to pureed foods (either smooth or rough) and with children's eating behavioural traits (high food enjoyment, high food responsiveness and low food fussiness). This pilot intervention demonstrated that providing information can be effective in promoting the introduction of small and soft food pieces, but the most effective way to influence the introduction of more challenging textures (hard pieces and double texture) is uncertain. Further research should focus on the identification of barriers to complex texture introduction and on how building on this knowledge for a population-based public health intervention.",2020,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"['Healthy infant feeding practices form the basis of healthy eating behaviour later in life', 'Sixty parent/child dyads']","['control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction']","['soft/small food pieces', 'children acceptance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0391997,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tournier', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: carole.tournier@inrae.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bernad', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Madrelle', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delarue', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cuvelier', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}]",Appetite,['10.1016/j.appet.2020.104989']
1341,33075592,Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study.,"OBJECTIVE


Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
METHOD


Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
RESULTS


Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
CONCLUSION


There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
CLINICAL TRIAL REGISTRATION


HeadPoST is registered at ClinicalTrials.gov (NCT02162017).",2020,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","['Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America', 'Secondary analysis of the Head Positioning in acute Stroke Trial ', '11,093 acute stroke patients at 114 hospitals in 9 countries', 'Of 11,086 patients included in analyses, 59.7% (n\xa0=\xa06620) had an ASU admission']","['HeadPoST', 'head-up versus head-down positioning']",['probability of receiving reperfusion therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.177773,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shenyang First People's Hospital, Shenyang, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital, Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia; Heart Health Research Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117187']
1342,33075621,Co-ingested vinegar-soaked or preloaded dried apple mitigated acute postprandial glycemia of rice meal in healthy subjects under equicarbohydrate conditions.,"This study investigated 2 possible approaches to dietary control of acute postprandial responses to a rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA. We hypothesized that both approaches would counteract hyperglycemia with no negative effect on satiety, possibly explained by an inhibitory effect on digestive enzyme activity and/or the effect of the sugar component of the DA. Fifteen healthy female subjects consumed (1) rice, (2) co-ingestion of DA and rice (DA + R), (3) DA preload and rice (PDA + R), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS + R), or (5) co-ingestion of rice with vinegar-soaked DA (VDA + R) in a randomized crossover trial. Acute postprandial glycemic response tests and subjective satiety tests were conducted for each test meal. Compared with rice reference, the PA + R and PSS + R achieved 31.4% and 36.3% reduction of the incremental area under the curve 0-120 , 24.3% and 27.0% decreases in the average glucose peak, along with 21.6% and 27.0% decreases in glycemic excursion in 240 minutes, whereas the VDA + R resulted 42.4%, 27.0%, and 29.7% reductions in the incremental area under the curve 0-120 , peak, and glycemic excursion, respectively. The DA-containing meals had no effect or a favorable effect on satiety. The in vitro assay found larger resistant starch and smaller rapid digestible starch fractions in DA + R and VDA + R meals compared to those of the rice reference (P < .001). The result of this study supported the research hypothesis, and the DA-containing meals could be considered as a potential dietary approach for glycemic management.",2020,The DA-containing meals had no effect or a favorable effect on satiety.,"['Fifteen healthy female subjects consumed (1) rice, (2', 'healthy subjects under equicarbohydrate conditions']","['co-ingestion of DA and rice (DA\u202f+\u202fR), (3) DA preload and rice (PDA\u202f+\u202fR), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS\u202f+\u202fR), or (5) co-ingestion of rice with vinegar-soaked DA (VDA\u202f+\u202fR', 'rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA', 'Co-ingested vinegar-soaked or preloaded dried apple']","['satiety', 'larger resistant starch and smaller rapid digestible starch fractions', 'Acute postprandial glycemic response tests and subjective satiety tests', 'average glucose peak', 'glycemic excursion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0453298', 'cui_str': 'Dried apple'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",15.0,0.0183585,The DA-containing meals had no effect or a favorable effect on satiety.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhaowenqi@cau.edu.cn.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: lynn9523@126.com.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China; Key Laboratory of Precision Nutrition and Food Quality, Department of Nutrition and Health, China Agricultural University, Beijing 100083. Electronic address: daisyfan@cau.edu.cn.'}, {'ForeName': 'Jiachan', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: jiacanlu0613@163.com.'}, {'ForeName': 'Ruixing', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhuruixin07@126.com.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: xiaoc0105@126.com.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: feirlu@163.com.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.09.003']
1343,33075644,Additive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.,"Assessment and personalised feedback are important components of brief interventions (BIs) for cannabis use. A key outcome is to increase motivation to change during this short interaction. The diversity of available assessments and time burden scoring them pose a challenge for routine use in clinical practice. An instant assessment and feedback (iAx) system was developed to administer assessments informed by bioSocial Cognitive Theory, that were instantly scored and benchmarked against clinical norms, to provide patient feedback and guide treatment planning. This study evaluated the feasibility and additive effectiveness of the iAx on motivation to change cannabis use, when compared to treatment as usual (TAU), in a single-session BI. A randomised controlled trial was conducted in a public hospital alcohol and drug outpatient clinic. Eighty-seven cannabis users (M age  = 26.41; 66% male) were assigned to the BI utilising the iAx (iAx; n = 44) or to the standard BI (TAU; n = 43). Patients completed pre- and post-BI assessments of motivation to change and a post-BI measure of treatment satisfaction. Practitioners completed a feedback survey. Patients receiving iAx reported a significantly greater increase in motivation to change from pre- to post-BI compared to patients receiving TAU (d = 0.49, p = .03). Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57). Practitioners also reported a high level of satisfaction with the iAx system. In summary, findings support the feasibility and additive effectiveness of the iAx to enhance patient motivation during cannabis BI.",2020,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","['Eighty-seven cannabis users (M age \xa0=\xa026.41; 66% male', 'brief cannabis intervention', 'public hospital alcohol and drug outpatient clinic']",['theory-driven instant assessment and feedback system'],"['Treatment satisfaction', 'motivation']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",87.0,0.0509742,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","[{'ForeName': 'Zoë E', 'Initials': 'ZE', 'LastName': 'Papinczak', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; School of Psychology, The University of Queensland, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Discipline of Psychiatry, School of Medicine, The University of Queensland, Brisbane, QLD 4029, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Gerald F X', 'Initials': 'GFX', 'LastName': 'Feeney', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gullo', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia. Electronic address: m.gullo@uq.edu.au.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106690']
1344,31833543,Antibiotic Cocktail for Pediatric Acute Severe Colitis and the Microbiome: The PRASCO Randomized Controlled Trial.,"BACKGROUND


Alterations in the microbiome have been postulated to drive inflammation in IBD. In this pilot randomized controlled trial, we evaluated the effectiveness of quadruple antibiotic cocktail in addition to intravenous-corticosteroids (IVCSs) in acute severe colitis (ASC).
METHODS


Hospitalized children with ASC (pediatric ulcerative colitis activity index [PUCAI] ≥65) were randomized into 2 arms: the first received antibiotics in addition to IVCS (amoxicillin, vancomycin, metronidazole, doxycycline/ciprofloxacin [IVCS+AB]), whereas the other received only IVCS for 14 days. The primary outcome was disease activity (PUCAI) at day 5. Microbiome was analyzed using 16S rRNA gene and metagenome.
RESULTS


Twenty-eight children were included: 16 in the AB + IVCS arm and 12 in the IVCS arm (mean age 13.9 ± 4.1 years and 23 [82%] with extensive colitis). The mean day-5 PUCAI was 25 ± 16.7 vs 40.4 ± 20.4, respectively (P = 0.037). Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89). Microbiome data at time of admission were analyzed for 25 children, of whom 17 (68%) had a predominant bacterial species (>33% abundance); response was not associated with the specific species, whereas decreased microbiome diversity at admission was associated with day-5 response in the IVCS arm.
CONCLUSION


Patients with ASC have alterations in the microbiome characterized by loss of diversity and presence of predominant bacterial species. Quadruple therapy in addition to IVCS improved disease activity on day 5, but larger studies are needed to determine whether this is associated with improved long-term outcomes (clinicaltrials.gov NCT02033408).",2020,"Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89).","['Pediatric Acute Severe Colitis and the Microbiome', 'acute severe colitis (ASC', 'Hospitalized children with ASC (pediatric ulcerative colitis activity index [PUCAI] ≥65', 'mean age 13.9\u2005±\u20054.1 years and 23 [82%] with extensive colitis', 'Twenty-eight children were included: 16 in the AB\u2005+\u2005IVCS arm and 12 in the IVCS arm']","['quadruple antibiotic cocktail', 'Antibiotic Cocktail', 'IVCS (amoxicillin, vancomycin, metronidazole, doxycycline/ciprofloxacin [IVCS+AB', 'intravenous-corticosteroids (IVCSs']","['mean day-5 PUCAI', 'Microbiome data at time of admission', 'disease activity (PUCAI', 'disease activity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C2931173', 'cui_str': 'Pediatric ulcerative colitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",28.0,0.157772,"Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bishai', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Reshef', 'Affiliation': 'School of Molecular Cell Biology and Biotechnology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Abitbol', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Focht', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Marcus', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Orlanski-Meyer', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Aloi', 'Affiliation': 'Sapienza University of Rome, Italy.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Griffiths', 'Affiliation': 'The Hospital for Sick Children (SickKids), Toronto, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Albenberg', 'Affiliation': ""The Children's Hospital of Philadelphia (CHOP), Philadelphia, PA, USA.""}, {'ForeName': 'Kaija-Leena', 'Initials': 'KL', 'LastName': 'Kolho', 'Affiliation': 'Hospital for Children and Adolescents, Children´s Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ""Schneider Children's Medical Center, Petah Tikvah, Israel.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Gophna', 'Affiliation': 'School of Molecular Cell Biology and Biotechnology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Vlamakis', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Lurz', 'Affiliation': 'Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig Maximilians-University, Munich, Germany.""}]",Inflammatory bowel diseases,['10.1093/ibd/izz298']
1345,33084881,Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.,"Importance


Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.
Objective


To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.
Design, Setting, and Participants


A registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.
Interventions


Patients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.
Main Outcomes and Measures


The trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.
Results


Seventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).
Conclusions and Relevance


Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT03283982.",2020,There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations.,"['Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair', 'Two surgeons at 1 academic tertiary care hospital']","['standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh', 'Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh', 'robotic platform', 'robotic approach to ventral hernia repair with intraperitoneal mesh', 'Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh']","['median operative time', 'NRS-11 scores', 'Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores', 'Baseline demographics and hernia characteristics', 'Numerical Rating Scale (NRS-11', 'median NRS-11 scores', 'Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost', 'length of stay and complication rates', 'cost of additional operating room time', 'operative time and proportional cost']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}]",,0.4073,There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations.,"[{'ForeName': 'Clayton C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Zolin', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krpata', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hemasat', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Lerner Research Institute, Department of Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA surgery,['10.1001/jamasurg.2020.4569']
1346,33084901,Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial.,"Importance


Suicide has been a leading manner of death for US Air Force personnel in recent years. Universal prevention programs that reduce suicidal thoughts and behaviors in military populations have not been identified.
Objectives


To determine whether the Wingman-Connect program for Airmen-in-training reduces suicidal ideation, depression, and occupational problems compared with a stress management program and to test the underlying network health model positing that cohesive, healthy units are protective against suicidal ideation.
Design, Setting, and Participants


This cluster randomized clinical trial was conducted from October 2017 to October 2019 and compared classes of personnel followed up for 6 months. The setting was a US Air Force technical training school, with participants studied to their first base assignment, whether US or international. Participants in 216 classes were randomized, with an 84% retention rate. Data analysis was performed from November 2019 to May 2020.
Interventions


The Wingman-Connect program used group skill building for cohesion, shared purpose, and managing career and personal stressors (3 blocks of 2 hours each). Stress management training covered cognitive and behavioral strategies (2 hours). Both conditions had a 1-hour booster session, plus text messages.
Main Outcomes and Measures


The primary outcomes were scores on the suicidal ideation and depression scales of the Computerized Adaptive Test for Mental Health and self-reports of military occupational impairment. Class network protective factors hypothesized to mediate the effect of Wingman-Connect were assessed with 4 measures: cohesion assessed perceptions that classmates cooperate, work well together, and support each other; morale was measured with a single item used in other studies with military samples; healthy class norms assessed perceptions of behaviors supported by classmates; and bonds to classmates were assessed by asking each participant to name classmates whom they respect and would choose to spend time with.
Results


A total of 215 classes including 1485 individuals (1222 men [82.3%]; mean [SD] age, 20.9 [3.1] years) participated; 748 individuals were enrolled in the Wingman-Connect program and 737 individuals were enrolled in the stress management program. At 1 month, the Wingman-Connect group reported lower suicidal ideation severity (effect size [ES], -0.23; 95% CI, -0.39 to -0.09; P = .001) and depression symptoms (ES, -0.24; 95% CI, -0.41 to -0.08; P = .002) and fewer occupational problems (ES, -0.14; 95% CI, -0.31 to -0.02; P = .02). At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06). The number needed to treat to produce 1 fewer participant with elevated depression at either follow-up point was 21. The benefits of the training on occupational problems did not extend past 1 month. The Wingman-Connect program strengthened cohesive, healthy class units, which helped reduce suicidal ideation severity (estimate, -0.035; 95% CI, -0.07 to -0.01; P = .02) and depression symptom scores (estimate, -0.039; 95% CI, -0.07 to -0.01; P = .02) at 1 month.
Conclusions and Relevance


Wingman-Connect is the first universal prevention program to reduce suicidal ideation and depression symptoms in a general Air Force population. Group training that builds cohesive, healthy military units is promising for upstream suicide prevention and may be essential for ecological validity. Extension of the program to the operational Air Force is recommended for maintaining continuity and testing the prevention impact on suicidal behavior.
Trial Registration


ClinicalTrials.gov Identifier: NCT04067401.",2020,"At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06).","['Air Force Personnel in Training', 'Participants in 216 classes', 'A total of 215 classes including 1485 individuals (1222 men [82.3%]; mean [SD] age, 20.9 [3.1] years) participated; 748 individuals were enrolled in the Wingman-Connect program and 737 individuals were enrolled in the stress management program']",['Wingman-Connect Upstream Suicide Prevention Program'],"['occupational problems', 'depression symptoms', 'suicidal ideation, depression, and occupational problems', 'suicidal ideation severity', 'depression symptom scores', 'suicidal ideation and depression symptoms', 'suicidal thoughts and behaviors', 'suicidal ideation and depression scales of the Computerized Adaptive Test for Mental Health and self-reports of military occupational impairment']","[{'cui': 'C0392328', 'cui_str': 'Air Force Personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",216.0,0.160435,"At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Wyman', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Pisani', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'C Hendricks', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Lacy', 'Initials': 'L', 'LastName': 'Morgan-DeVelder', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schmeelk-Cone', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gibbons', 'Affiliation': 'Department of Medicine, Biological Sciences, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Caine', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Petrova', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Neal-Walden', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Linkh', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matteson', 'Affiliation': 'US Air Force, Head Quarters Air Force, Washington, DC.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Simonson', 'Affiliation': 'US Air Force, Head Quarters Air Force, Washington, DC.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Pflanz', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.22532']
1347,33089293,[Clinical study of Bio-Oss powder and Bio-Oss collagen for site preservation during implantology].,"PURPOSE


To investigate the effect of Bio-Oss bone powder combined with Heal-All Oral repair membrane and Bio-Oss collagen on site preservation during implantology.
METHODS


A total of 26 cases were randomly divided into 2 groups. In Bio-Oss bone powder group (13 cases), the sockets were filled with Bio-Oss bone powder, covering with Heal-All Oral repair membrane on the surface. In Bio-Oss collagen group (13 cases), the sockets were filled with Bio-Oss collagen only. The changes in alveolar bone density，height，width and new bone contour were evaluated with cone-beam CT(CBCT) after site preservation. The data were analyzed with SPSS 17.0 software package.
RESULTS


There was no significant difference in new bone contour between 2 groups(P>0.05). The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
CONCLUSIONS


There is no significant difference in the efficacy of site preservation between the two materials. However, the site preservation technique using collagen is simple, less invasive and less costly.",2020,"The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
",['A total of 26 cases'],"['Bio-Oss powder and Bio-Oss collagen', 'Bio-Oss bone powder combined with Heal-All Oral repair membrane and Bio-Oss collagen']","['efficacy of site preservation', 'new bone contour', 'alveolar bone density，height，width and new bone contour', 'height, width and grey level of alveolar bone']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",26.0,0.0196675,"The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': ""Department of Stomatology, The Third Affiliated Hospital of Soochow University, The First People's Hospital of Changzhou City. Changzhou 213003, China. E-mail:xudan1984318@163.com.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
1348,31250180,Radiomics-based prediction of microsatellite instability in colorectal cancer at initial computed tomography evaluation.,"PURPOSE


To predict microsatellite instability (MSI) status of colon cancer on preoperative CT imaging using radiomic analysis.
METHODS


This retrospective study involved radiomic analysis of preoperative CT imaging of patients who underwent resection of stage II-III colon cancer from 2004 to 2012. A radiologist blinded to MSI status manually segmented the tumor region on CT images. 254 Intensity-based radiomic features were extracted from the tumor region. Three prediction models were developed with (1) only clinical features, (2) only radiomic features, and (3) ""combined"" clinical and radiomic features. Patients were randomly separated into training (n = 139) and test (n = 59) sets. The model was constructed from training data only; the test set was reserved for validation only. Model performance was evaluated using AUC, sensitivity, specificity, PPV, and NPV.
RESULTS


Of the total 198 patients, 134 (68%) patients had microsatellite stable tumors and 64 (32%) patients had MSI tumors. The combined model performed slightly better than the other models, predicting MSI with an AUC of 0.80 for the training set and 0.79 for the test set (specificity = 96.8% and 92.5%, respectively), whereas the model with only clinical features achieved an AUC of 0.74 and the model with only radiomic features achieved an AUC of 0.76. The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
CONCLUSIONS


Preoperative prediction of MSI status via radiomic analysis of preoperative CT adds specificity to clinical assessment and could contribute to personalized treatment selection.",2019,"The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
","['Of the total 198 patients, 134 (68', 'patients who underwent resection of stage II-III colon cancer from 2004 to 2012', 'patients had microsatellite stable tumors and 64 (32%) patients had MSI tumors']",['preoperative CT imaging'],"['AUC, sensitivity, specificity, PPV, and NPV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}]",,0.0245261,"The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Golia Pernicka', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA. goliapej@mskcc.org.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Gagniere', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jayasree', 'Initials': 'J', 'LastName': 'Chakraborty', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Yamashita', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Nardo', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Creasy', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Petkovska', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Richard R K', 'Initials': 'RRK', 'LastName': 'Do', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'David D B', 'Initials': 'DDB', 'LastName': 'Bates', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Viktoriya', 'Initials': 'V', 'LastName': 'Paroder', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gonen', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Weiser', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Simpson', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gollub', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}]",Abdominal radiology (New York),['10.1007/s00261-019-02117-w']
1349,33091586,Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.,"Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least 40% of older adults. Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD) and demonstrate decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may be a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the objective of the proposed study is to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia. An exploratory aim is to assess the effect of CBT-I on rate of Aβ accumulation.",2020,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[""Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD"", 'older adults with symptoms of insomnia']","['CBT-I', 'Cognitive behavioral therapy']","['rate of Aβ deposition', 'Chronic insomnia', 'cognitive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0637426,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[{'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America. Electronic address: csiengsukon@kumc.edu.'}, {'ForeName': 'Eryen', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Williams-Cooke', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ludwig', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eber Silveira', 'Initials': 'ES', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America; Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States of America.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Sleep Disorders Clinic, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri - Kansas City School of Medicine, Kansas City, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106190']
1350,33091587,Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.,"BACKGROUND


Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants.
METHODS


Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services).
DISCUSSION


The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03448575.",2020,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","['Youth (SUAY', '800 youth aged 3-17\u202fyears', 'Recruitment occurs at 4 health systems', 'youth with non-psychotic disorders', 'participants']","['EHR-based best practice alert with options to expedite access to psychosocial care', 'antipsychotics']",['person-days of antipsychotic medication use'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0803332,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","[{'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Robert.B.Penfold@kp.org.'}, {'ForeName': 'Ella E', 'Initials': 'EE', 'LastName': 'Thompson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hilt', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver, CO, USA.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Hartzler', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R Yates', 'Initials': 'RY', 'LastName': 'Coley', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Akosile', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'Dipartimento di Scienze della Sanità Pubblica e Pediatriche, University of Turin, Turin, Italy.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106184']
1351,33092219,Effects of an Activity Tracker and App Intervention to Increase Physical Activity in Whole Families-The Step It Up Family Feasibility Study.,"(1) Background: Interventions using activity trackers and smartphone apps have demonstrated their ability to increase physical activity in children and adults. However, they have not been tested in whole families. Further, few family-centered interventions have actively involved both parents and assessed physical activity effects separately for children, mothers and fathers. Objective: To examine the feasibility and short-term effects of an activity tracker and app intervention to increase physical activity in the whole family (children, mothers and fathers). (2) Methods: This was a single-arm feasibility study with pre-post intervention measures. Between 2017-2018, 40 families (58 children aged 6-10 years, 39 mothers, 33 fathers) participated in the 6-week  Step it Up Family  program in Queensland, Australia. Using commercial activity trackers combined with apps (Garmin Vivofit Jr for children, Vivofit 3 for adults; Garmin Australasia Pty Ltd., Sydney, Australia), the intervention included individual and family-level goal-setting, self-monitoring, performance feedback, family step challenges, family social support and modelling, weekly motivational text messages and an introductory session. Parent surveys were used to assess physical activity effects measured as pre-post intervention changes in moderate-to-vigorous physical activity (MVPA) in children, mothers and fathers. Objective Garmin activity tracker data was recorded to assess physical activity levels (steps, active minutes) during the intervention. (3) Results: Thirty-eight families completed the post intervention survey (95% retention). At post intervention, MVPA had increased in children by 58 min/day (boys: 54 min/day, girls: 62 min/day; all  p  < 0.001). In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001). The percentage of children meeting Australia's physical activity guidelines for children (≥60 MVPA min/day) increased from 34% to 89% ( p  < 0.001). The percentage of mothers and fathers meeting Australia's physical activity guidelines for adults (≥150 MVPA min/week) increased from 8% to 57% ( p  < 0.001) in mothers and from 21% to 68% ( p  < 0.001) in fathers. The percentage of families with 'at least one child and both parents' meeting the physical activity guidelines increased from 0% to 41% ( p  < 0.001). Objective activity tracker data recorded during the intervention showed that the mean ( SD ) number of active minutes per day in children was 82.1 (17.1). Further, the mean ( SD ) steps per day was 9590.7 (2425.3) in children, 7397.5 (1954.2) in mothers and 8161.7 (3370.3) in fathers. (4) Conclusions: Acknowledging the uncontrolled study design, the large pre-post changes in MVPA and rather high step counts recorded during the intervention suggest that an activity tracker and app intervention can increase physical activity in whole families. The  Step it Up Family  program warrants further efficacy testing in a larger, randomized controlled trial.",2020,"In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001).","['Whole Families', 'Between 2017-2018, 40 families (58 children aged 6-10 years, 39 mothers, 33 fathers) participated in the 6-week  Step it Up Family  program in Queensland, Australia', 'children, mothers and fathers', 'whole family (children, mothers and fathers', 'children and adults']","['Activity Tracker and App Intervention', 'commercial activity trackers combined with apps (Garmin Vivofit Jr', 'activity trackers and smartphone apps', 'activity tracker and app intervention']","['Objective Garmin activity tracker data', 'physical activity guidelines', 'mean ( SD ) number of active minutes', ""percentage of mothers and fathers meeting Australia's physical activity guidelines"", 'Physical Activity', 'physical activity effects', 'physical activity', 'moderate-to-vigorous physical activity (MVPA', 'physical activity levels (steps, active minutes', ""percentage of children meeting Australia's physical activity guidelines"", 'Objective activity tracker data', 'MVPA']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",58.0,0.0336325,"In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001).","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schoeppe', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, 221 Burwood Highway, Burwood, Geelong, VIC 3125, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Williams', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alley', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Rebar', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hayman', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17207655']
1352,33092527,Intravesical dexmedetomidine instillation reduces postoperative catheter-related bladder discomfort in male patients under general anesthesia: a randomized controlled study.,"BACKGROUND


The catheter-related bladder discomfort (CRBD) of male patients is a common clinical problem, albeit lacking effective solutions. The present study aimed to investigate whether intravesical dexmedetomidine instillation alleviates the postoperative urinary discomfort in male patients with catheter under general anesthesia.
METHODS


This single-blinded, prospective, randomized study included a total of 167 male patients American Society of Anesthesiologists (ASA) physical status I-II scheduled for surgery under general anesthesia were allocated to two groups: 84 in the dexmedetomidine group and 83 in the control group. Dexmedetomidine group patients received intravesical instillation of the drug 0.5 μg/kg and normal saline 20 mL, while the control group received intravesical instillation of 20 mL normal saline. The catheter was clamped for 30 min after intravesical instillation for all patients. CRBD scores and urethra pain numerical rating scale (NRS) scores were measured at admittance to post-anesthesia care unit (PACU) (T0), intravesical instillation (T1), 30 min (T2), 60 min (T3), 2 h (T4) after intravesical instillation, discharged from PACU (T5), and 6 h (T6) and 24 h (T7) after the operation. Patient satisfaction at discharge from PACU and 24 h post-operation were compared between the two groups.
RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001). No differences were detected in Steward score out of PACU (p = 0.213) and from the time of the end of operation to fully awake (p = 0.417).
CONCLUSION


Intravesical dexmedetomidine instillation reduces postoperative urinary discomfort and urethra pain and improves satisfaction in male patients under general anesthesia.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (No. ChiCTR1800016429 ), date of registration 1st June 2018.",2020,"RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001).","['male patients under general anesthesia', '167 male patients American Society of Anesthesiologists (ASA) physical status I-II scheduled for surgery under general anesthesia', 'male patients', 'male patients with catheter under general anesthesia']","['intravesical dexmedetomidine instillation', 'Intravesical dexmedetomidine instillation', 'intravesical instillation of the drug 0.5\u2009μg/kg and normal saline 20\u2009mL, while the control group received intravesical instillation of 20\u2009mL normal saline', 'Dexmedetomidine', 'dexmedetomidine', 'dexmedetomidine instillation']","['patient satisfaction', 'CRBD scores and urethra pain numerical rating scale (NRS) scores', 'postoperative urinary discomfort', 'postoperative catheter-related bladder discomfort', 'CRBD scores and urethra pain NRS scores', 'postoperative urinary discomfort and urethra pain and improves satisfaction']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151830', 'cui_str': 'Pain in urethra'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",167.0,0.236948,"RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China. zhangye_hassan@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01189-2']
1353,33075061,"Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights.","REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.",2020,"REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.",['130 human subjects'],['placebo'],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.631299,"REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.","[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jisuk', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Sa Rang', 'Initials': 'SR', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Moon', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Yeob', 'Initials': 'DY', 'LastName': 'Shin', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0240358']
1354,33075711,The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points.,"Abnormal muscle stiffness is a potential complication after injury and identifying interventions that modify muscle stiffness may be useful to promote recovery. The purpose of this study was to identify the short-term effects of dry needling (DN) on resting and contracted gastrocnemius muscle stiffness and strength of the triceps surae in individuals with latent myofascial trigger points (MTrPs). In this randomized controlled trial, 52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two sham needling sessions. Resting and contracted muscle stiffness were assessed both at the treatment site and a standardized central site in the medial gastrocnemius head immediately post-treatment and one week after the last session. There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29). Post-needling between group comparison indicated that the DN group had significantly lower resting muscle stiffness at the site of the MTrP than the sham group after adjusting for baseline differences. There were no significant between group differences in contracted muscle stiffness or muscle strength. Identifying strategies that can reduce aberrant muscle stiffness may help to guide management of individuals with neuromuscular pain-related conditions. Level of evidence: Therapy, level 2.",2020,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","['participants with latent trigger points', '52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two', 'individuals with latent myofascial trigger points (MTrPs', 'individuals with neuromuscular pain-related conditions']","['sham needling sessions', 'dry needling', 'dry needling (DN']","['resting muscle stiffness', 'contracted muscle stiffness or muscle strength', 'gastrocnemius muscle stiffness and strength', 'Level of evidence', 'Resting and contracted muscle stiffness', 'time interactions for resting muscle stiffness']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1405031', 'cui_str': 'Neuromuscular pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.067405,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University Doctoral Program in Physical Therapy, Waco, TX, United States.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'MacDonald', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capoccia', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ngo', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phippen', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendlandt', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hoffman', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102479']
1355,33076217,Long Term Dietary Restriction of Advanced Glycation End-Products (AGEs) in Older Adults with Type 2 Diabetes Is Feasible and Efficacious-Results from a Pilot RCT.,"INTRODUCTION


High serum concentrations of advanced glycation end-products (AGEs) in older adults and diabetics are associated with an increased risk of cognitive impairment. The aim of this pilot study was to assess the feasibility of long-term adherence to a dietary intervention designed to decrease intake and exposure to circulating AGEs among older adults with type 2 diabetes.
METHODS


Herein, 75 participants were randomized to either a standard of care (SOC) control arm or to an intervention arm receiving instruction on reducing dietary AGEs intake. The primary outcome was a change in serum AGEs at the end of the intervention. Secondary and exploratory outcomes included adherence to diet and its association with circulating AGEs. Cognitive function and brain imaging were also assessed but were out of the scope of this article (ClinicalTrials.gov Identifier: NCT02739971).
RESULTS


The intervention resulted in a significant change over time in several serum AGEs compared to the SOC guidelines. Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels. There were no significant differences between the two arms in any other metabolic markers.
CONCLUSIONS


A long-term dietary intervention to reduce circulating AGEs is feasible in older adults with type 2 diabetes, especially in those who are highly adherent to the AGE-lowering diet.",2020,Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels.,"['Herein, 75 participants', 'older adults and diabetics', 'older adults with type 2 diabetes', 'Older Adults with Type 2 Diabetes']","['standard of care (SOC) control arm or to an intervention arm receiving instruction on reducing dietary AGEs intake', 'dietary intervention', 'Advanced Glycation End-Products (AGEs']","['change in serum AGEs', 'time in several serum AGEs', 'Cognitive function and brain imaging', 'adherence to diet and its association with circulating AGEs', 'serum AGEs levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.0412427,Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels.,"[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Lotan', 'Affiliation': 'The Nutrition and Brain Health Laboratory, The Institute of Biochemistry, Food and Nutrition Science, The Robert H. Smith Faculty of Agriculture Food and the Environment, The Hebrew University of Jerusalem, 7610001 Rehovot, Israel.'}, {'ForeName': 'Ithamar', 'Initials': 'I', 'LastName': 'Ganmore', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Shelly', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Zacharia', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Uribarri', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Beisswenger', 'Affiliation': 'PreventAGE Healthcare, Lebanon, NH 03766, USA.'}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Aron M', 'Initials': 'AM', 'LastName': 'Troen', 'Affiliation': 'The Nutrition and Brain Health Laboratory, The Institute of Biochemistry, Food and Nutrition Science, The Robert H. Smith Faculty of Agriculture Food and the Environment, The Hebrew University of Jerusalem, 7610001 Rehovot, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Schnaider Beeri', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}]",Nutrients,['10.3390/nu12103143']
1356,33076229,"A Randomized Controlled Trial Testing the Effectiveness of Coping with Cancer in the Kitchen, a Nutrition Education Program for Cancer Survivors.","Following a diet rich in whole grains, vegetables, fruit, and beans may reduce cancer incidence and mortality. The aim of this study was to investigate the effect of Coping with Cancer in the Kitchen (CCK), an 8 week in-person program offering education, culinary demonstrations and food tasting, and psychosocial group support, compared to receiving CCK printed materials by mail on knowledge, confidence, and skills in implementing a plant-based diet. A total of 54 adult cancer survivors were randomly assigned to intervention ( n  = 26) and control groups ( n  = 27) with assessments at baseline, 9, and 15 weeks via self-administered survey. The response rate was 91% at 9 weeks and 58% at 15 weeks. The majority of our study participants were female breast cancer survivors (58%) who had overweight or obesity (65%). Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15. There was a significant reduction in processed meat intake but changes in other food groups and psychosocial measures were modest. Participation in CCK in person increased knowledge, skills, and confidence and reduced barriers to adopting a plant-based diet. Positive trends in intake of plant-based foods and quality of life warrant further investigation in larger-scale studies and diverse populations.",2020,"Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","['Cancer Survivors', 'participants were female breast cancer survivors (58%) who had overweight or obesity (65', '54 adult cancer survivors']",['Coping with Cancer in the Kitchen (CCK'],"['processed meat intake', 'response rate', 'cancer incidence and mortality']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}]","[{'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",54.0,0.0413395,"Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","[{'ForeName': 'Melissa Farmer', 'Initials': 'MF', 'LastName': 'Miller', 'Affiliation': 'Department of Public Health, College of Health Sciences, Arcadia University, Glenside, PA 19038, USA.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Habedank', 'Affiliation': 'American Institute for Cancer Research, Arlington, VA 22209, USA.'}]",Nutrients,['10.3390/nu12103144']
1357,33076263,Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase: A Nutrient and Mechanotransduction Crossroads.,"Research has suggested that nutrient, exercise, and metabolism-related proteins interact to regulate mammalian target of rapamycin complex one (mTOR) post-exercise and their interactions needs clarification. In a double-blind, cross-over, repeated measures design, ten participants completed four sets to failure at 70% of 1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin (2 g/kg) after a 3 h fast. Vastus lateralis biopsies were collected at baseline before supplementation and 1 h post-exercise to analyze Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase (PI3K), and 5' AMP-activated protein kinase (AMPK) activation. FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05). PI3K and p70S6K activation were both elevated after exercise in both conditions ( p  < 0.05). However, AMPK activity did not change from baseline in both conditions ( p  > 0.05). We conclude that FAK does not induce mTOR activation through PI3K crosstalk in response to exercise alone. In addition, FAK may not be regulated by AMPK catalytic activity, but this needs further research. Interestingly, carbohydrate-induced insulin signaling appears to activate FAK at the level of IRS-1 but did not enhance mTOR activity 1 h post-exercise greater than the placebo condition. Future research should investigate these interactions under different conditions and within different time frames to clearly understand the interactions between these signaling molecules.",2020,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05).,[],"['FAK', 'Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase', '1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin']","['AMPK activity', 'mTOR activity', 'PI3K and p70S6K activation', 'Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase', ""PI3K), and 5' AMP-activated protein kinase (AMPK) activation"", 'FAK and IRS-1 activity']",[],"[{'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C1136240', 'cui_str': 'p70 S6 Kinase'}, {'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C2827383', 'cui_str': 'ribosomal protein S6 kinase beta 1'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}]",10.0,0.113269,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}]",Nutrients,['10.3390/nu12103145']
1358,33084773,Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil.,"OBJECTIVE


to evaluate the effect of oral cryotherapy compared to physiological serum on the development of oral mucositis in outpatient cancer patients using the 5-fluorouracil antineoplastic agent.
METHOD


this is a controlled, randomized, double-blind, and multi-center clinical trial, conducted with 60 patients undergoing chemotherapy. The experimental group (n=30) used oral cryotherapy during the infusion of the 5-FU antineoplastic agent, while the control group (n=30) performed mouthwash with physiological serum at their homes. The oral cavity of the participants was assessed at three times: before randomization, and on the 7th and 14th days after using 5-FU. For data analysis, descriptive analyses and the ANOVA, paired t, and McNemar tests were used.
RESULTS


there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis. However, cryotherapy presented the chance to reduce the presence of intragroup mucositis, between the first and second assessments (p=0.000126).
CONCLUSION


cryotherapy did not obtain statistical significance in relation to oral hygiene with serum, but it proved to be effective intragroup. Record number: RBR-4k7zh3.",2020,there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis.,"['outpatient cancer patients using the 5-fluorouracil antineoplastic agent', '60 patients undergoing chemotherapy']","['5-fluorouracil', '5-FU', 'oral cryotherapy', '5-FU antineoplastic agent, while the control group (n=30) performed mouthwash with physiological serum at their homes', 'cryotherapy']","['oral mucositis', 'grade of mucositis', 'mucositis', 'presence of intragroup mucositis']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",60.0,0.0313439,there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis.,"[{'ForeName': 'Andrea Bezerra', 'Initials': 'AB', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Maria Isis Freire De', 'Initials': 'MIF', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Patrícia Peres De', 'Initials': 'PP', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de São João Del Rey, Departamento de Enfermagem, Divinópolis, MG, Brazil.'}, {'ForeName': 'Naiana Pacifico', 'Initials': 'NP', 'LastName': 'Alves', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Renan Alves', 'Initials': 'RA', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Espírito Santo, Departamento de Ciências da Saúde, São Mateus, ES, Brazil.'}, {'ForeName': 'Willame De Oliveira', 'Initials': 'WO', 'LastName': 'Vitorino', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Thays Silva De Souza', 'Initials': 'TSS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3953.3363']
1359,33085123,VVI Pacing with normal QRS duration and ventricular function: MOST trial findings relevant to leadless pacemakers.,"BACKGROUND


Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction Trial (MOST) showed similar outcomes in patients randomized to dual chamber (DDDR) vs ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST.
METHODS


Patients enrolled in the MOST study with an LVEF >35%, QRSd <120ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure hospitalization and atrial fibrillation (AF).
RESULTS


Of the 2,010 patients enrolled in MOST, 1,284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over four years of follow-up, there was no association between pacing mode and death, stroke or heart failure hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
CONCLUSION


In patients without reduced LVEF or prolonged QRS duration who would be eligible for LP, DDDR and VVIR pacing demonstrated similar rates of death, stroke or heart failure hospitalization; however, VVIR pacing significantly increased the risk of AF development. This article is protected by copyright. All rights reserved.",2020,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","['2,010 patients enrolled in MOST, 1,284 patients (64%) met inclusion criteria', 'LP-eligible patients from MOST', 'Patients enrolled in the MOST study with an LVEF >35%, QRSd <120ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population']","['dual chamber (DDDR) vs ventricular pacing (VVIR', 'VVI Pacing']","['pacing mode and death, stroke or heart failure hospitalization', 'rates of death, stroke or heart failure hospitalization', 'pacing mode and death, stroke or heart failure hospitalization and atrial fibrillation (AF', 'LVEF or prolonged QRS duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0428908', 'cui_str': 'Sinus node dysfunction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",2010.0,0.0306833,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","[{'ForeName': 'Zak', 'Initials': 'Z', 'LastName': 'Loring', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'North', 'Affiliation': 'Department of Statistics, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Hellkamp', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Atwater', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Camille G', 'Initials': 'CG', 'LastName': 'Frazier-Mills', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jackson', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14100']
1360,33080294,The effects of an internet-based mindfulness meditation intervention on electrophysiological markers of attention.,"Evidence suggests that mindfulness meditation training has the potential to train aspects of attention. However, the neurophysiological mechanisms underpinning the attentional benefits from mindfulness remain unclear. This randomized controlled trial examined changes in electrophysiological markers of attention before and after completion of a 6-week internet-based mindfulness intervention. EEG and ERP data were collected from 64 generally healthy, mildly stressed older adults. Participants were randomized to an internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition. Attentional N2 and P3 evoked potentials were derived from active and passive auditory oddball paradigms. Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls. There were no significant relationships between the intervention and N2 potentials. Our data demonstrate a measurable increase in attentional control when discriminating or directing attention away from auditory stimuli for older adult participants who received mindfulness training. These findings lend support to the use of the P3 as a neurophysiological measure of meditation engagement and intervention efficacy.",2020,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"['64 generally healthy, mildly stressed older adults']","['internet-based mindfulness meditation intervention', 'mindfulness meditation training', 'internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition', '6-week internet-based mindfulness intervention']","['attentional control', 'P3 peak-trough amplitude', 'Attentional N2 and P3 evoked potentials']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",64.0,0.0204774,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Klee', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America. Electronic address: klee@ohsu.edu.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, United States of America.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America; Oregon Health & Science University, Departments of Behavioral Neuroscience and Biomedical Engineering, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.002']
1361,33080379,Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial.,"INTRODUCTION


Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
OBJECTIVES


To describe the methodology of a randomized clinical trial to evaluate the impact of Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latino smokers.
METHODS


Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates three integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. Promotores de Salud will rely on community-based approaches and clinical settings to recruit smokers into the study. All participants will complete follow-up assessments at Week 12 and Month 6.
DISCUSSION


If successful, Decídetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.",2020,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","['Latino smokers', 'latino smokers', 'Latino smokers (N\u202f=\u202f618']","['Decídetexto or 2) standard of care', 'Decídetexto', 'pharmacotherapy (nicotine patches or gum', 'Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",[],618.0,0.0411656,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America. Electronic address: Francisco_Cartujano@URMC.Rochester.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Department of Oncology, Georgetown University, Washington, D.C., United States of America.'}, {'ForeName': 'Chinwe', 'Initials': 'C', 'LastName': 'Ogedegbe', 'Affiliation': 'Emergency and Trauma Center, Hackensack University Medical Center, Hackensack, NJ, United States of America.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106188']
1362,33080411,The effect of dietary nitrate on exercise capacity in chronic kidney disease: a randomized controlled pilot study.,"BACKGROUND


Chronic Kidney Disease (CKD) patients exhibit a reduced exercise capacity that impacts quality of life. Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise. This study investigated whether dietary nitrates would acutely improve exercise capacity in CKD patients.
METHODS AND RESULTS


In this randomized, double-blinded crossover study, 12 Stage 3-4 CKD patients (Mean ± SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6 ml/min/1.73 m 2 ) received an acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA). Skeletal muscle mitochondrial oxidative function was assessed using near-infrared spectroscopy. Cardiopulmonary exercise testing was performed on a cycle ergometer, with intensity increased by 25 W every 3 min until volitional fatigue. Plasma nitric oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound NO) were determined by gas-phase chemiluminescence. Plasma NOm values were significantly increased following BRJ (BRJ vs. PLA: 1074.4 ± 120.4 μM vs. 28.4 ± 6.6 μM, p < 0.001). Total work performed (44.4 ± 10.6 vs 39.6 ± 9.9 kJ, p = 0.03) and total exercise time (674 ± 85 vs 627 ± 86s, p = 0.04) were significantly greater following BRJ. Oxygen consumption at the ventilatory threshold was also improved by BRJ (0.90 ± 0.08 vs. 0.74 ± 0.06 L/min, p = 0.04). These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p = 0.52) and VO 2peak  (p = 0.35).
CONCLUSIONS


Our findings demonstrate that inorganic nitrate can acutely improve exercise capacity in CKD patients. The effects of chronic nitrate supplementation on CKD related exercise intolerance should be investigated in future studies.",2020,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","['12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an', 'Chronic Kidney Disease (CKD) patients', 'CKD patients', 'chronic kidney disease']","['chronic nitrate supplementation', 'dietary nitrate', 'acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA', 'BRJ (BRJ vs. PLA', 'dietary nitrates', 'Dietary nitrate supplementation', 'inorganic nitrate']","['total exercise time', 'Oxygen consumption', 'skeletal muscle mitochondrial oxidative capacity', 'Plasma NOm values', 'Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound', 'exercise capacity', 'Skeletal muscle mitochondrial oxidative function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0141313', 'cui_str': 'S-Nitrosothiol'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.142506,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology, West Chester University, West Chester, PA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; School of Health Sciences, Stockton University, Stockton, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Paschalis-Thomas', 'Initials': 'PT', 'LastName': 'Doulias', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Ischiropoulos', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. Electronic address: dge@udel.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.10.002']
1363,33080415,Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial.,"BACKGROUND


Spinal anesthesia for cesarean section can be complicated by hypotension, with untoward effects for both the mother and fetus. Frequently used phenylephrine can lead to baroreceptor-mediated reflex bradycardia. The aim of the present study was to compare a fixed-rate prophylactic norepinephrine infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia.
MATERIALS AND METHODS


Eighty-two parturients were randomized to either norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution. The primary endpoint was the incidence of maternal bradycardia. Maternal hemodynamics at specific timepoints, the incidence of hypotension or hypertension, the requirement for ephedrine or atropine bolus administration as well as the acid-base status and Apgar score of the neonate were recorded.
RESULTS


The incidence of bradycardia as well as the requirement for atropine administration was lower in the norepinephrine group (4.8% vs. 31.7%, p = 0.004 and 2.4% vs. 24.3%, p = 0.01, respectively). Fetal pH, and fetal blood glucose concentration were higher in the norepinephrine group (p = 0.027 and 0.019, respectively). No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
CONCLUSIONS


A fixed-rate infusion of norepinephrine is as effective in the management of hypotension during regional anesthesia for cesarean section as a fixed-rate infusion of phenylephrine, with the avoidance of phenylephrine-induced bradycardia. The more favourable neonatal acid-base profile of noradrenaline might be due to better maintenance of placental blood flow in the noradrenaline group due to its beta action, while the higher fetal glucose concentration in the same group might result from a catecholamine-stimulated glucose metabolism increase and a β-receptor mediated insulin decrease.",2020,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","['Eighty-two parturients', 'hypotension during elective cesarean section with a']","['norepinephrine', 'fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine', 'norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution', 'phenylephrine', 'phenylephrine infusion']","['Maternal hemodynamics', 'incidence of hypotension or hypertension', 'incidence of bradycardia', 'occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores', 'fetal glucose concentration', 'Fetal pH, and fetal blood glucose concentration', 'incidence of maternal bradycardia', 'placental blood flow']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",82.0,0.245385,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","[{'ForeName': 'Kassiani', 'Initials': 'K', 'LastName': 'Theodoraki', 'Affiliation': '1st Department of Anesthesiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ktheodoraki@hotmail.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Hadzilia', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Valsamidis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.10.006']
1364,33080562,Effect of Modified Constrain Induced Movement Therapy on Fatigue and Motor Performance in Sub Acute Stroke.,"OBJECTIVES


There is a little available information about the fatigue status among people receiving modified constraint induced movement therapy. The study examined such changes. The effect of using restraint on motor performance was also evaluated in sub acute phase after stroke.
MATERIALS AND METHODS


The study was designed as two group pretest and post-test study. The experimental design included a pretest and post test measures of dependent variables fatigue and motor function. All patients were recruited from the Safdurjung Hospital. 20 patients in subacute phase of stroke (3-9 months), (N = 10) mean age±SD 51.90±15.27, MAS score mean ± SD 1.90±.316 and post stroke duration mean ±SD 6.45±2.26 were included in the experimental group and (N = 10) mean age ± SD 54.10±17.42, MAS score mean ±SD 1.52±0.52 and post stroke duration mean±SD score 4.55± 2.52 were included in the control group. The subjects in the experimental group were restrained for six hours every week day with task training for 2 h per day five times a week for three weeks and the subjects in the controlled group received task training for 2 h per day five times a week for three weeks with no restrain. Motor Performance and fatigue were measured on day to day basis by Wolf Motor Function Test Scores (WMFT) and 11th item of Barrow Neurological Institute (BNI) scale in both experimental and controlled group.
RESULTS


The restraint group exhibited significant better motor performance than the controlled group. Mean difference between Pre- WMFT scores and Post WMFT scores were (0.533±.362) as compared to controlled group (0.192±.23). No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57). Difference between the experimental and controlled group in motor performance and fatigue scores were nonsignificant.
CONCLUSIONS


Restraint improves motor performance in subacute therapy group and the intensive practice associated with m-CIMT may be administered without the exacerbation of fatigue.",2020,No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57).,"['sub acute phase after stroke', 'Sub Acute Stroke', '20 patients in subacute phase of stroke (3-9 months), (N = 10) mean', 'All patients were recruited from the Safdurjung Hospital', 'mean ±SD 6.45±2.26 were included in the experimental group and (N = 10']","['task training', 'Modified Constrain Induced Movement Therapy', 'Restraint']","['Motor Performance and fatigue', 'motor performance', 'motor performance and fatigue scores', 'mean Pre- BNI and Post - BNI scores', 'MAS score mean ± SD 1.90±.316 and post stroke duration', 'Pre- WMFT scores and Post WMFT scores', 'Wolf Motor Function Test Scores (WMFT) and 11th item of Barrow Neurological Institute (BNI) scale', 'Fatigue and Motor Performance']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.0452297,No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57).,"[{'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Mushtaq', 'Affiliation': 'Jamia Hamdard, India. Electronic address: Woohaw88@yahoo.com.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Hamdani', 'Affiliation': 'Jamia Hamdard University, India. Electronic address: nhamdani@jamiahamdard.ac.in.'}, {'ForeName': 'Majumi M', 'Initials': 'MM', 'LastName': 'Noohu', 'Affiliation': 'Centre for Physiotherapy and Rehablitation Sciences, Jamia Milia University, New Delhi, India. Electronic address: majuminoohu@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Safdurjung Hospital New Delhi, India. Electronic address: raghavansamudrala@yahoo.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105378']
1365,33080817,Novel Resistance Training Approach to Monitoring the Volume in Older Adults: The Role of Movement Velocity.,"We analyzed the effects of velocity-monitored resistance training (RT) with a velocity loss of 20% on strength and functional capacity in institutionalized older adults. Thirty-nine participants (78.8 ± 6.7 years) were divided into a control group (CG;  n  = 20) or an RT group ( n  = 19). Over 10 weeks, the RT group performed two sessions per week, and the mean velocity of each repetition was monitored in the leg-press and chest-press exercises at 40-65% of one-repetition maximum (1RM). The set ended when the participants reached a velocity loss of 20%. The CG maintained their daily routine. At pre- and post-test, both groups were assessed in the 1RM leg-press, 1RM chest-press, handgrip strength, medicine ball throw (MBT), walking speed, and sit-to-stand (STS). At baseline, we did not find significant differences between groups. After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS. The RT group performed a total number of repetitions of 437.6 ± 66.1 in the leg-press and 296.4 ± 78.9 in the chest-press. Our results demonstrate that velocity loss effectively prescribes the volume in older adults and that a threshold of 20% improves strength-related variables in this population.",2020,"After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS.","['older adults', 'Thirty-nine participants (78.8 ± 6.7 years', 'institutionalized older adults', 'Older Adults']","['velocity-monitored resistance training (RT', 'Novel Resistance Training Approach']","['velocity loss', '1RM leg-press, 1RM chest-press, handgrip strength, medicine ball throw (MBT), walking speed, and sit-to-stand (STS', 'mean velocity of each repetition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",39.0,0.0241822,"After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS.","[{'ForeName': 'Diogo L', 'Initials': 'DL', 'LastName': 'Marques', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17207557']
1366,33080822,Effect of an Additional 30 Minutes Spent Outdoors during Summer on Daily Steps and Individually Experienced Heat Index.,"Spending time outdoors is associated with increased physical activity; however, high ambient temperature/humidity, together with built environment features in urban versus rural environments, may influence physical activity. We conducted an intervention trial with 89 urban and 88 rural participants performing normal activities on Days 1-2 (baseline) and spending an additional 30 min outdoors on Days 3-7 (intervention) in the summer. Participants wore a pedometer with real-time visual feedback to track daily steps taken and a thermometer clipped to their shoe to track temperatures experienced individually. Hygrometer-thermometers were deployed in participants' neighborhoods to collect finer resolution ambient heat indexes in addition to regional weather station measurements. Using linear mixed effects models and adjusting for ambient conditions and individual-level factors, participants on average walked 637 (95%CI (83, 1192)) more steps and had a 0.59 °C (95%CI (0.30, 0.88)) lower daily mean individually experienced heat index during intervention days compared to baseline days. The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents. Our results suggest adding a small amount of additional time outdoors may improve physical activity without increasing participants' heat exposure, even during summer in a humid subtropical climate.",2020,"The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents.","['89 urban and 88 rural participants performing normal activities on Days 1-2 (baseline) and spending an additional 30 min outdoors on Days 3-7 (intervention) in the summer', 'rural residents who were less active at baseline, compared to urban residents']",[],['physical activity'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0877572,"The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents.","[{'ForeName': 'Suwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Translational Biology, Medicine, and Health (TBMH), Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Richardson', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35205, USA.'}, {'ForeName': 'Connor Y H', 'Initials': 'CYH', 'LastName': 'Wu', 'Affiliation': 'Department of Geospatial Informatics, Troy University, Troy, AL 36082, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Zaitchik', 'Affiliation': 'Department of Earth and Planetary Sciences, Johns Hopkins University, Baltimore, MD 21218, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Gohlke', 'Affiliation': 'Department of Population Health Sciences, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17207558']
1367,33080839,Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility in Women.,"While vitamin D insufficiency is known to impact a multitude of health outcomes, including HIV-1, little is known about the role of vitamin D-mediated immune regulation in the female reproductive tract (FRT). We performed a pilot clinical study of 20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants were randomized into either weekly or daily high-dose oral vitamin D supplementation groups. In addition to serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection, were assessed. While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied. Paradoxically, post-supplementation vitamin D levels were decreased in cervicovaginal fluids. Given the strong correlation between vitamin D status and HIV-1 infection and the widespread nature of vitamin D deficiency, further understanding of the role of vitamin D immunoregulation in the female reproductive tract is important.",2020,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","['Women', '20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants']",['daily high-dose oral vitamin D supplementation'],"['post-supplementation vitamin D levels', 'serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection', 'Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",20.0,0.15141,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Jackson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Asin', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rollenhagen', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Ghosh', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Nikolas C', 'Initials': 'NC', 'LastName': 'Vann', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Meredith R', 'Initials': 'MR', 'LastName': 'Clark', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}]",Nutrients,['10.3390/nu12103176']
1368,33080845,Wearable Biofeedback Improves Human-Robot Compliance during Ankle-Foot Exoskeleton-Assisted Gait Training: A Pre-Post Controlled Study in Healthy Participants.,"The adjunctive use of biofeedback systems with exoskeletons may accelerate post-stroke gait rehabilitation. Wearable patient-oriented human-robot interaction-based biofeedback is proposed to improve patient-exoskeleton compliance regarding the interaction torque's direction (joint motion strategy) and magnitude (user participation strategy) through auditory and vibrotactile cues during assisted gait training, respectively. Parallel physiotherapist-oriented strategies are also proposed such that physiotherapists can follow in real-time a patient's motor performance towards effective involvement during training. A preliminary pre-post controlled study was conducted with eight healthy participants to conclude about the biofeedback's efficacy during gait training driven by an ankle-foot exoskeleton and guided by a technical person. For the study group, performance related to the interaction torque's direction increased during ( p -value = 0.07) and after ( p -value = 0.07) joint motion training. Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training. The experimental group and a technical person reported promising usability of the biofeedback and highlighted the importance of the timely cues from physiotherapist-oriented strategies. Less significant improvements in patient-exoskeleton compliance were observed in the control group. The overall findings suggest that the proposed biofeedback was able to improve the participant-exoskeleton compliance by enhancing human-robot interaction; thus, it may be a powerful tool to accelerate post-stroke ankle-foot deformity recovery.",2020,"Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training.","['eight healthy participants', 'Healthy Participants']","['Wearable Biofeedback Improves Human-Robot Compliance during Ankle-Foot Exoskeleton-Assisted Gait Training', 'gait training driven by an ankle-foot exoskeleton and guided by a technical person']",['patient-exoskeleton compliance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",8.0,0.0170267,"Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training.","[{'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Pinheiro', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Figueiredo', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Magalhães', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Santos', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}]","Sensors (Basel, Switzerland)",['10.3390/s20205876']
1369,33080863,Effects of Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise on Chronic Ankle Instability: A Pilot Randomized and Double-Blinded Study.,"(1) Background: Balance decline is highly prevalent in people suffering from chronic ankle instability (CAI). The control of balance depends upon multiple neurophysiologic systems including the activation of cortical brain regions (e.g., the primary sensorimotor cortex). The excitability of this region, however, is diminished in people with CAI. In this pilot double-blinded randomized controlled trial, we tested the effects of high-definition transcranial direct current stimulation (HD-tDCS) designed to facilitate the excitability of M1 and S1 in combination with short-foot exercise (SFE) training on proprioception and dynamic balance performance in individuals with CAI. (2) Methods: Thirty young adults completed baseline assessments including the Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT). They were then randomized to receive a four-week intervention of SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation. Baseline assessments were repeated once-weekly throughout the intervention and during a two-week follow-up period. (3) Results: Twenty-eight participants completed this study. Blinding procedures were successful and no adverse events were reported. As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points. No group by time interaction was observed in AMEDA test performance. (4) Conclusions: HD-tDCS combined with SFE may improve dynamic balance and proprioception in CAI. Larger, more definitive trials with extended follow-up are warranted.",2020,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","['people with CAI', 'individuals with CAI', 'Thirty young adults', 'Chronic Ankle Instability', 'people suffering from chronic ankle instability (CAI']","['SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation', 'HD-tDCS+SFE', 'Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise', 'SFE', 'short-foot exercise (SFE) training', 'high-definition transcranial direct current stimulation (HD-tDCS']","['successful and no adverse events', 'JPR test, the Y balance test, and the SOT', 'dynamic balance and proprioception in CAI', 'Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT', 'proprioception and dynamic balance performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}]",30.0,0.261914,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","[{'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100749']
1370,33093457,Irreversible electroporation plus allogenic Vγ9Vδ2 T cells enhances antitumor effect for locally advanced pancreatic cancer patients.,"Immunotherapy has limited efficacy against locally advanced pancreatic cancer (LAPC) due to the presence of an immunosuppressive microenvironment (ISM). Irreversible electroporation (IRE) can not only induce immunogenic cell death, but also alleviate immunosuppression. This study aimed to investigate the antitumor efficacy of IRE plus allogeneic γδ T cells in LAPC patients. A total of 62 patients who met the eligibility criteria were enrolled in this trial, then randomized into two groups (A: n = 30 and B: n = 32). All patients received IRE therapy and after receiving IRE, the group A patients received at least two cycles of γδ T-cell infusion as one course continuously. Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months). Moreover, the group A patients treated with multiple courses of γδ T-cell infusion had longer OS (17 months) than those who received a single course (13.5 months). IRE combined with allogeneic γδ T-cell infusion is a promising strategy to enhance the antitumor efficacy in LAPC patients, yielding extended survival benefits.ClinicalTrials.gov ID: NCT03180437.",2020,Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months).,"['62 patients who met the eligibility criteria', 'LAPC patients', 'locally advanced pancreatic cancer patients']","['Irreversible electroporation plus allogenic Vγ9Vδ2 T cells', 'IRE therapy and after receiving IRE', 'IRE combined with allogeneic γδ T-cell infusion', 'Irreversible electroporation (IRE', 'IRE plus allogeneic γδ T cells', 'Immunotherapy']","['antitumor efficacy', 'better survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C4319935', 'cui_str': 'Irreversible electroporation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",62.0,0.0478856,Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months).,"[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Medical Research Centre, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alnaggar', 'Affiliation': 'Department of Oncology, Tongji Chibi Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chibi, 437300, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'The Biomedical Translational Research Institute, Faculty of Medical Science, Jinan University, Guangzhou, 510632, China.'}, {'ForeName': 'Jibing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biological Treatment Center, Fuda Cancer Hospital, Jinan University, Guangzhou, 510665, China. jibingchen398@163.com.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Biological Treatment Center, Fuda Cancer Hospital, Jinan University, Guangzhou, 510665, China. 18922210657@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China. jiang48231@163.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-020-00260-1']
1371,33094162,A Mental Health-Physical Health-Violence (MPV) Syndemic Factor in Women with Mental Disorders.,"This study extended research on syndemics for women with mental disorders by including self-reported mental and physical health conditions. Syndemics explain complex relationships among co-occurring conditions, and the social circumstances that influence their overlap. Data were from the baseline assessment of a randomized trial of Healthy Home, a nursing home-visit intervention for women with children. 172 adult women who were in mental health or substance use treatment completed measures (in Spanish or English) of anxiety, depression, violence during adulthood, physical health, and cigarette use. Structural Equation Modeling was used to evaluate a single-factor syndemic, and to test the relationships of theoretical predictors of the syndemic: income, number of children, women's abuse during childhood, mental health stigma, social support, and stress. Results supported a single factor syndemic model that explained variation in mental health, physical health, and violence during adulthood. Stress, β = .45,  p  < .001, and stigma, β = .22,  p  = .007, were related to the syndemic factor. There was evidence that self-reported mental and physical health share covariation, which suggested that integrated services for women with mental disorders may have synergistic effects on health. Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.",2019,Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.,"['women with mental disorders', 'women with children', 'Women with Mental Disorders', 'women with mental disorders by including self-reported mental and physical health conditions', '172 adult women who were in mental health or substance use treatment completed measures (in Spanish or English) of anxiety, depression, violence during adulthood, physical health, and cigarette use']",['nursing home-visit intervention'],"['mental health, physical health, and violence during adulthood']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]",172.0,0.0396416,Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.,"[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McCabe', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Gonzalez-Guarda', 'Affiliation': 'School of Nursing, Duke University.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'de Tantillo', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}, {'ForeName': 'Victoria B', 'Initials': 'VB', 'LastName': 'Mitrani', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}]",Stigma and health,['10.1037/sah0000152']
1372,33094728,Effects of empagliflozin on proinflammatory cytokines and other coronary risk factors in patients with type 2 diabetes mellitus: A single-arm real-world observation.,"OBJECTIVE


This single-arm real-world observation aims to examine the effects of empagliflozin (EMPA) on coronary risk factors among subjects with known diabetes.
MATERIALS AND METHODS


Records of 63 subjects with type 2 diabetes mellitus, receiving EMPA were drawn for this study. Of 63 patients with diabetes, 6 were excluded, and the remaining 57 received EMPA (25 mg/day) for 24 weeks. Clinical data, dietary intakes, and physical activity were assessed by validated questionnaires.
RESULTS


Treatment with EMPA was associated with significant decline in fasting and 2-hour post-prandial blood glucose and Hb1c indicating that this agent has potential antidiabetic effects. Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels. Apart from these changes, parameters of oxidative stress, thiobarbituric acid reactive substances, malondialdehyde, and diene conjugates as well as uric acid, showed a significant decline with an increase in antioxidant vitamins A, E, and C and beta-carotene as well as nitrite. There was a significant decline in serum uric acid, systolic and diastolic blood pressures, and angiotensin-converting enzyme (ACE), with a non-significant reduction in body weight and body mass index as well as in waist circumference of modest significance, after intervention of 12 weeks compared to baseline levels. Total cholesterol, VLDL cholesterol and triglycerides showed non-significant decline compared to baseline levels.
CONCLUSION


It is possible that EMPA administration can cause a significant decline in pro-inflammatory cytokines along with blood glucose, Hb1c, oxidative stress, uric acid, blood pressures, and ACE with an increase in antioxidant vitamins and nitrite. Randomized, controlled intervention trials would be necessary to confirm our findings.",2020,"Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels.","['patients with type 2 diabetes mellitus', 'Records of 63 subjects with type 2 diabetes mellitus, receiving EMPA were drawn for this study', 'subjects with known diabetes', '63 patients with diabetes']","['EMPA', 'empagliflozin', 'empagliflozin (EMPA']","['serum uric acid, systolic and diastolic blood pressures, and angiotensin-converting enzyme (ACE', 'coronary risk factors', 'Total cholesterol, VLDL cholesterol and triglycerides', 'fasting and 2-hour post-prandial blood glucose', 'body weight and body mass index', 'oxidative stress, thiobarbituric acid reactive substances, malondialdehyde, and diene conjugates', 'Clinical data, dietary intakes, and physical activity', 'antioxidant vitamins A, E, and C and beta-carotene', 'proinflammatory cytokines and other coronary risk factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0053396', 'cui_str': 'Beta Carotene'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",63.0,0.0443367,"Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels.","[{'ForeName': 'Ram B', 'Initials': 'RB', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Ghizal', 'Initials': 'G', 'LastName': 'Fatima', 'Affiliation': ''}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fedacko', 'Affiliation': ''}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Mojto', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Isaza', 'Affiliation': ''}, {'ForeName': 'Nar', 'Initials': 'N', 'LastName': 'SinghVerma', 'Affiliation': ''}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': ''}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': ''}, {'ForeName': 'Banshi', 'Initials': 'B', 'LastName': 'Saboo', 'Affiliation': ''}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203787']
1373,33095139,Ianalumab (VAY736) in primary Sjögren's syndrome: assessing disease activity using multi-modal ultrasound.,"OBJECTIVES


To apply serial ultrasound (US) assessments to show effects of ianalumab (anti-BAFF-R monoclonal antibody) on inflamed salivary glands of patients with primary Sjögren's syndrome (pSS).
METHODS


In a single-centre, 24-week double-blind study (NCT02149420), 27 pSS patients of moderate-to-severe activity were randomly assigned to receive a single i.v. dose of either 3 mg/kg or 10 mg/kg ianalumab, or placebo. Concurrent with clinical and laboratory outcomes, multi-modal US images were acquired of bilateral parotid glands (PG) and submandibular glands (SMG) at weeks 0, 6, 12, and 24. Applied US modalities included 1) B-mode echostructure scored by de Vita classification, 2) macrovascular blood flow by power Doppler, and in PG only 3) microvascularisation using contrast-enhanced US (area under the curve, time to peak or TTP) and 4) gland stiffness by sonoelastography.
RESULTS


Clinical study results were previously published. US data for PG differed from SMG but were comparable between respective left and right sides of these glands. Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness. Correlations between clinical endpoints and US parameters were largely restricted to microvascular perfusion TTP and at the 12-week timepoint when ianalumab effects were predicted at maximal.
CONCLUSIONS


Early in vivo signs of salivary gland improvement in response to an effective intervention can be shown without need of biopsy by using a non-invasive, comprehensive, ultrasound-based approach over multiple time points.",2020,"Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness.","[""primary Sjögren's syndrome"", '27 pSS patients of moderate-to-severe activity', ""patients with primary Sjögren's syndrome (pSS""]","['ianalumab (anti-BAFF-R monoclonal antibody', 'placebo']",['salivary gland quality and declining tissue inflammation'],"[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C1384654', 'cui_str': 'TNFRSF13C protein, human'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",27.0,0.0993281,"Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness.","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Institute for Radiology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': 'Institute for Radiology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Quirino', 'Initials': 'Q', 'LastName': 'Schefer', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Maximilian Georg', 'Initials': 'MG', 'LastName': 'Posch', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'Department of Medicine/Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Stephen John', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland. stephen.oliver@novartis.com.'}]",Clinical and experimental rheumatology,[]
1374,33095180,Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice.,"In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.",2020,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"['With Tic Disorders', 'children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial', 'Children and Young People']","['Therapist-Supported Online Interventions', 'internet-based cognitive behavioral therapy (iCBT', '4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention']",[],"[{'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.052188,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"[{'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Chamberlain', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Andrén', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'E Bethan', 'Initials': 'EB', 'LastName': 'Davies', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kilgariff', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kouzoupi', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR mental health,['10.2196/19600']
1375,33095184,Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Pilot Randomized Controlled Trial.,"BACKGROUND


Around 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.
OBJECTIVE


This study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.
METHODS


Chinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.
RESULTS


The program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.
CONCLUSIONS


Our program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.
TRIAL REGISTRATION


ANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-18071.",2020,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","['Chinese male smokers', '80 participants who were randomly allocated to two arms (n=40 per arm', 'Chinese male smokers aged 25-44 years', 'Chinese Male Smokers']","['smoking cessation interventions', 'Mobile Social Network-Based Smoking Cessation Intervention', 'incentive credit payments', 'access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines', 'mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program']","['smoking abstinence', '30-day biochemically verified smoking abstinence', 'calculator function, motivational messages, and health tests', 'smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",80.0,0.0814973,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/17522']
1376,33096028,Diagnostic value of parameters from a spot urine sample for renal potassium loss in hypokalemia.,"BACKGROUND


We assessed the value of 1) a spot urine test for diagnosing hypokalemia caused by renal potassium loss, and 2) actual 24-hour urine potassium excretion (24 hUK-actual) for diagnosing hypokalemia caused by renal potassium loss in patients treated with potassium supplementation. The study population was from Southwest China.
METHODS


Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n = 67) and hypokalemia caused by extrarenal potassium loss (n = 63). Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated) were derived from spot urine samples collected on admission, before initiation of therapy. Patients received intravenous potassium chloride 0.4 or 0.6 g/h. 24 hUK-actual was detected in patients whose serum potassium did not return to normal after 24 h of therapy.
RESULTS


Patients with hypokalemia caused by renal potassium loss had significantly higher UK, UK/UCr, FEK, TTKG and 24 hUK-calculated compared to patients with hypokalemia caused by extrarenal potassium loss (P < 0.05). FEK predicted renal potassium loss in hypokalemia with high accuracy at a cut-off of 9.29% (sensitivity, 80.6%; specificity, 85.7%). The area under the curve for 24 hUK-actual in predicting renal potassium loss in patients with hypokalemia treated with low or high-dose potassium chloride infusion were 0.939 or 0.956, respectively. On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r = 0.831, p < 0.001 or r = 0.764, p < 0.001).
CONCLUSIONS


FEK from a spot urine sample represents a convenient and reliable parameter to predict renal potassium loss in patients with hypokalemia.",2020,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","['Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63', 'hypokalemia', 'The study population was from Southwest China', 'patients with hypokalemia', 'patients with hypokalemia treated with low or high-dose']","['potassium chloride infusion', 'intravenous potassium chloride', 'potassium supplementation']","['renal potassium loss', 'Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0360652', 'cui_str': 'Potassium-containing product in parenteral dose form'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202195', 'cui_str': 'Potassium measurement, urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0248461,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China. Electronic address: lijia0876@126.com.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.10.024']
1377,33096291,Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial.,"BACKGROUND


Pre-extinction fear memory reactivation (PE-FMR) and deepened extinction (DE) enhance long-term extinction of shock-conditioned fear, and may also enhance long-term extinction of naturally acquired fear. Preliminary data suggest that PE-FMR may additionally boost the speed of fear reduction during exposure therapy.
DESIGN


Randomized controlled trial, factorial design.
METHODS


Participants with elevated fears of either spiders or snakes were randomized to (1) exposure therapy alone (n = 41), (2) exposure therapy + PE-FMR (n = 42), (3) exposure therapy + DE (n = 41), or (4) exposure therapy + PE-FMR + DE (n = 42). Participants were assessed at baseline, post-treatment, and one-week follow-up on subjective and behavioral indices of phobia. Because treatment length was tailored to speed of fear reduction, survival analyses were used to examine the speed of fear reduction during treatment.
RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
CONCLUSIONS


Data suggest that PE-FMR is a promising strategy for reducing the overall duration of exposure-based therapies.
CLINICAL TRIAL REGISTRATION


(clinicaltrials.gov)NCT02160470.",2020,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
",['Participants with elevated fears of either spiders or snakes'],"['Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction', 'PE-FMR', 'exposure therapy alone (n\xa0=\xa041), (2) exposure therapy\xa0+\xa0PE-FMR (n\xa0=\xa042), (3) exposure therapy\xa0+\xa0DE (n\xa0=\xa041), or (4) exposure therapy\xa0+\xa0PE-FMR\xa0+\xa0DE']","['clinical outcomes', 'rapid fear reduction']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",42.0,0.0830397,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA; Department of Psychology, University of Nevada, Reno. 1664 N. Virginia Street, Mail Stop 0298. Reno, NV, USA. Electronic address: cynthialancaster@unr.edu.'}, {'ForeName': 'Marie-H', 'Initials': 'MH', 'LastName': 'Monfils', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA. Electronic address: telch@austin.utexas.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103730']
1378,33096332,"The role of expressive suppression and cognitive reappraisal in cognitive behavioral therapy for social anxiety disorder: A study of self-report, subjective, and electrocortical measures.","BACKGROUND


Contemporary models of cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) emphasize emotion dysregulation as a core impairment whose reduction may play a causal role in psychotherapy. The current study examined changes in use of emotion regulation strategies as possible mechanisms of change in CBT for SAD. Specifically, we examined changes in expressive suppression and cognitive reappraisal during CBT and whether these changes predict treatment outcome.
METHODS


Patients (n = 34; 13 females; Mean age = 28.36 (6.97)) were allocated to 16-20 sessions of CBT. An electrocortical measure of emotion regulation and a clinician-rated measure of SAD were administered monthly. Self-report measures of emotion regulation and social anxiety were administered weekly. Multilevel models were used to examine changes in emotion regulation during treatment and cross-lagged associations between emotion regulation and anxiety.
RESULTS


CBT led to decreased suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures (ps < .05). At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli. Gains were maintained at 3-months follow-up. Decreases in suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety but not the other way around (ps < .05). Lower anxiety predicted greater subsequent increases in reappraisal self-efficacy.
LIMITATIONS


The lack of a control group precludes conclusions regarding mechanisms specificity.
CONCLUSIONS


Decreased frequency of suppression is a potential mechanism of change in CBT for SAD.",2020,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","['Patients (n\xa0', 'social anxiety disorder', '34; 13 females; Mean age\xa0=\xa028.36 (6.97']","['cognitive behavioral therapy (CBT', 'expressive suppression and cognitive reappraisal in cognitive behavioral therapy']","['emotion regulation', 'emotion regulation and social anxiety', 'suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety', 'suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures', 'expressive suppression and cognitive reappraisal', 'reappraisal self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0112977,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: yogev.kivity@biu.ac.il.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.021']
1379,33096497,"Feasibility of a Nurse-Trained, Family Member-Delivered Rehabilitation Model for Disabled Stroke Patients in Rural Chongqing, China.","BACKGROUND AND OBJECTIVE


Stroke rehabilitation was seriously inadequate in rural regions of China. This study aimed to evaluate the feasibility of a novel nurse-trained, family member-delivered rehabilitation model for disabled stroke patients in rural southwest China.
METHODS


A single-center randomized controlled trial was conducted at a rural county hospital in Chongqing, China. Eligible stroke patients were randomly assigned to an intervention group or to a control group. In the intervention group, patients and their caregivers received stroke rehabilitation training focusing on mobility, self-care, and toileting delivered by trained nurses before discharge, and 3 post-discharge telephone calls at 2nd, 4th, and 8th week. The control group received routine care. The primary outcome was functional independence indicating by Barthel Index (BI) scores, and secondary outcomes included health-related quality of life (EuroQol five dimensions questionnaire, EQ-5D) and caregiver burden (Caregiver Burden Inventory, CBI). Outcome assessment was carried out at pre-discharge, 3- and 6-months after discharge.
RESULTS


A total of 61 stroke patients were recruited and randomly assigned to the intervention group (n=31) or the control group (n = 30). Compared with that in the control group, BI increased more at 3 months and decreased less at 6 months in the intervention group, there was a significant difference in mean BI scores across the three time points (F = 21.96, p = 0.0001), but no significant between-group difference (F = 0.94, p = 0.3371). In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = 0.0001; t = 4.14, p = 0.0003). In the control group, BI scores at 3 months were higher than that before discharge (t = 5.29, p = 0.0001), but no significant difference at 6 months. At 6 months post-discharge, the intervention group and the control group had similar EQ-5D scores (p = 0.91), and similar CBI scores (3.67 vs 3.68, p = 0.98).
CONCLUSIONS


The study showed that the novel nurse-trained, family member-delivered rehabilitation model improved physical recovery indicated by BI scores without increasing caregiver burden, compared to usual care, for rural stroke patients in southwest China.",2020,"In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = ","['rural stroke patients in southwest China', 'Disabled Stroke Patients in Rural Chongqing, China', 'Eligible stroke patients', '61 stroke patients', 'rural county hospital in Chongqing, China', 'rural regions of China', 'disabled stroke patients in rural southwest China']","['stroke rehabilitation training focusing on mobility, self-care, and toileting delivered by trained nurses before discharge, and 3 post-discharge telephone calls', 'Nurse-Trained, Family Member-Delivered Rehabilitation Model', 'novel nurse-trained, family member-delivered rehabilitation model', 'routine care']","['BI scores', 'functional independence indicating by Barthel Index (BI) scores, and secondary outcomes included health-related quality of life (EuroQol five dimensions questionnaire, EQ-5D) and caregiver burden (Caregiver Burden Inventory, CBI', 'EQ-5D scores', 'similar CBI scores', 'mean BI scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0020005', 'cui_str': 'County Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0259095', 'cui_str': '9a-chloromethyl-1,2,9,9a-tetrahydrocyclopropa(c)benz(e)indol-4-one'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",61.0,0.102098,"In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = ","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China. Electronic address: chukun@stu.cqmu.edu.cn.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Yuzhong Center for Disease Control and Prevention, Chongqing 400010, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Fuyan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China. Electronic address: tangxiaoj0726@qq.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105382']
1380,33096517,Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial.,"STUDY OBJECTIVE


Spinal fusion surgery is associated with severe postoperative pain. We examined whether bilateral ultrasound-guided erector spinae plane block could alleviate postoperative pain in patients undergoing lumbar spinal fusion.
DESIGN


Blinded, randomized, controlled study.
SETTING


Tertiary university hospital, operating room, postoperative recovery room and ward.
PATIENTS


Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery were randomized into the erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio.
INTERVENTIONS


Pre-operative ultrasound-guided bilateral erector spinae plane block was performed in the ESPB group, while sham subcutaneous infiltration was performed in the control group.
MEASUREMENTS


The primary outcome was pain intensity at rest within 12 h postoperatively using the Numeric Rating Scale (NRS). Secondary outcomes included NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48 h after surgery.
MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023). The two groups showed similar pain scores at rest at 24 h after surgery (estimated mean difference - 0.2, 95% CI -0.8 to 0.5) and 48 h (-0.3, 95% CI -0.8 to 0.2). The ESPB group also showed significantly lower pain score on movement at 4 h after surgery (-1.5, 95% CI -2.5 to -0.6). The ESPB group showed a significantly smaller proportion of patients requiring sufentanil within 12 h after surgery (p = 0.020), and the group consumed significantly less sufentanil during that period (p = 0.042).
CONCLUSIONS


Bilateral ultrasound-guided erector spinae plane block improves postoperative analgesia in patients undergoing lumbar spinal fusion.",2020,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","['Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery', 'patients undergoing lumbar spinal fusion', 'Tertiary university hospital, operating room, postoperative recovery room and ward']","['sufentanil', 'bilateral ultrasound-guided erector spinae plane block', 'Pre-operative ultrasound-guided bilateral erector spinae plane block', 'erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio', 'ESPB', 'Bilateral ultrasound-guided erector spinae plane block']","['postoperative analgesia', 'pain intensity at rest within 12\xa0h postoperatively using the Numeric Rating Scale (NRS', 'smaller proportion of patients requiring sufentanil', 'pain score', 'pain scores', 'similar pain scores', 'NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.356452,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China. Electronic address: yifeng_65@163.com.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110090']
1381,33096545,Does acute soccer heading cause an increase in plasma S100B? A randomized controlled trial.,"The purpose of this study was to test the effect of subconcussive head impacts on acute changes in plasma S100B. In this randomized controlled trial, 79 healthy adult soccer players were randomly assigned to either the heading (n = 41) or kicking-control groups (n = 38). The heading group executed 10 headers with soccer balls projected at a speed of 25 mph, whereas the kicking-control group performed 10 kicks. Plasma samples were obtained at pre-, 0h post-, 2h post- and 24h post-intervention and measured for S100B. The primary hypothesis was that there would be a significant group difference (group-by-time interaction) in plasma S100B at 2h post-intervention. Secondary hypotheses included (1) no significant group differences in plasma S100B concentrations at 0h post- and 24h post-intervention; (2) a significant within-group increase in S100B concentrations in the heading group at 2h post-intervention compared to pre-intervention; and (3) no significant within-group changes in plasma S100B in the kicking-control group. Data from 68 subjects were available for analysis (heading n = 37, kicking n = 31). There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20). Part of the secondary outcome, the heading group showed elevation in plasma S100B concentrations at 24h post-intervention compared to pre-heading baseline (B = 19.57, 95%CI [3.13, 36.02], p = 0.02), whereas all other within-group comparisons in both remained nonsignificant. The data suggest that 10 bouts of acute controlled soccer headings do not elevate S100B concentrations up to 24-hour post-heading. Further dose-response studies with longer follow-up time points may help determine thresholds of acute soccer heading exposure that are related to astrocyte activation. The protocol was registered under ClinicalTrials.gov (NCT03488381; retrospectively registered.).",2020,"There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20).","['79 healthy adult soccer players', '68 subjects were available for analysis (heading n = 37, kicking n = 31']",[],"['plasma S100B', 'acute changes in plasma S100B', 'elevation in plasma S100B concentrations', 'plasma S100B concentrations', 'S100B concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",79.0,0.196685,"There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Huibregtse', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Madeleine K', 'Initials': 'MK', 'LastName': 'Nowak', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Kalbfell', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Alekhya', 'Initials': 'A', 'LastName': 'Koppineni', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ejima', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kawata', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0239507']
1382,33096557,An Expression of Concern from The Journal of Nutrition's Editorial Office about: High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial.,,2020,,['Patients with Multiple Sclerosis'],['ω-3 Fatty Acid Plus Vitamin D3'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",[],,0.0930488,,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afarini', 'Affiliation': ''}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Abolhassani', 'Affiliation': ''}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': ''}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Masoud', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa342']
1383,33096567,Home treatment of pulmonary embolism: are all the questions answered now after the HOME-PE trial?,,2020,,['pulmonary embolism'],[],[],"[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",[],[],,0.0178576,,"[{'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}]",Cardiovascular research,['10.1093/cvr/cvaa289']
1384,33096665,"Association between Peak Expiratory Flow Rate and Exposure Level to Indoor PM2.5 in Asthmatic Children, Using Data from the Escort Intervention Study.","Various studies have indicated that particulate matter <2.5 μm (PM2.5) could cause adverse health effects on pulmonary functions in susceptible groups, especially asthmatic children. Although the impact of ambient PM2.5 on children's lower respiratory health has been well-established, information regarding the associations between indoor PM2.5 levels and respiratory symptoms in asthmatic children is relatively limited. This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea. We aimed to evaluate the effects of indoor PM2.5 on children's peak expiratory flow rate (PEFR), with a daily intervention of air purifiers with filter on, compared with those groups with filter off. Children aged between 6-12 years diagnosed with asthma were enrolled and randomly allocated into two groups. During a crossover intervention period of seven weeks, we observed that, in the filter-on group, indoor PM2.5 levels significantly decreased by up to 43%. ( p  < 0.001). We also found that the daily or weekly unit (1 μg/m 3 ) increase in indoor PM2.5 levels could significantly decrease PEFR by 0.2% (95% confidence interval (CI) = 0.1 to 0.5) or PEFR by 1.2% (95% CI = 0.1 to 2.7) in asthmatic children, respectively. The use of in-home air filtration could be considered as an intervention strategy for indoor air quality control in asthmatic children's homes.",2020,"This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea.","['Asthmatic Children', 'Children aged between 6-12 years diagnosed with asthma', ""asthmatic children's homes"", ""26 asthmatic children's homes located in Incheon metropolitan city, Korea"", 'asthmatic children']","['indoor PM2.5', 'ambient PM2.5']","['indoor PM2.5 levels', ""children's peak expiratory flow rate (PEFR"", 'Peak Expiratory Flow Rate and Exposure Level to Indoor PM2.5', 'PEFR']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1510837', 'cui_str': 'Air Pollutants, Particulate'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",26.0,0.0356171,"This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea.","[{'ForeName': 'Sungroul', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Jungeun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Rudasingwa', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sangwoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of ICT Environmental Health System, Graduate School, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, School of Medicine, Inha University, Incheon 22332, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207667']
1385,33096684,Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers? A Randomized Controlled Trial.,"The aim of this study was to determine the efficacy of an energy restriction intermittent fasting diet in metabolic biomarkers and weight management among adults with metabolic syndrome. This randomized controlled study was performed with metabolic syndrome patients, aged 18-65 years, at an academic institution in Istanbul, Turkey ( n  = 70). All participants were randomized to the Intermittent Energy Restriction (IER) intervention group and Continuous Energy Restriction (CER) control group. Biochemical tests including lipid profile, fasting plasma glucose, insulin, glycosylated hemoglobin Type A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), blood pressure, and body composition were evaluated at baseline and at the 12th week in diet interviews. Dietary intake was measured with the 24-h dietary recall method and dietary quality was evaluated with the Healthy Eating Index-2010. Changes in body weight (≈7% weight loss) and composition were similar in both groups. Blood pressure, total cholesterol, triglyceride, low-density lipoprotein (LDL), fasting glucose, and insulin at the 12th week decreased in both groups ( p  < 0.05). No significant differences were observed in metabolic syndrome biomarkers between the IER and CER groups. The energy-restricted intermittent fasting diet did not cause any deficiencies in macronutrient and fiber intake in the subjects. Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values. The technique used to achieve energy restriction, whether intermittent or continuous, appears to alleviate the metabolic syndrome biomarkers activated by weight loss.",2020,"Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values.","['metabolic syndrome patients, aged 18-65 years, at an academic institution in Istanbul, Turkey ( n  = 70', 'adults with metabolic syndrome']","['energy restriction intermittent fasting diet', 'Intermittent Energy Restriction (IER) intervention group and Continuous Energy Restriction (CER) control group']","['24-h dietary recall method and dietary quality', 'Healthy Eating Index (HEI) index scores', 'Dietary intake', 'body weight', 'Blood pressure, total cholesterol, triglyceride, low-density lipoprotein (LDL), fasting glucose, and insulin', 'metabolic syndrome biomarkers', 'lipid profile, fasting plasma glucose, insulin, glycosylated hemoglobin Type A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), blood pressure, and body composition']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0146629,"Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values.","[{'ForeName': 'Yasemin Ergul', 'Initials': 'YE', 'LastName': 'Kunduraci', 'Affiliation': 'Institute of Health Sciences, Nutrition and Dietetics, Istanbul Medipol University, 34815 Istanbul, Turkey.'}, {'ForeName': 'Hanefi', 'Initials': 'H', 'LastName': 'Ozbek', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Istanbul Medipol University, 34815 Istanbul, Turkey.'}]",Nutrients,['10.3390/nu12103213']
1386,33096745,Effects of Growth Hormone Treatment and Rehabilitation in Incomplete Chronic Traumatic Spinal Cord Injury: Insight from Proteome Analysis.,"Despite promising advances in the medical management of spinal cord injury (SCI), there is still no available effective therapy to repair the neurological damage in patients who experience this life-transforming condition. Recently, we performed a phase II/III placebo-controlled randomized trial of safety and efficacy of growth hormone (GH) treatment in incomplete chronic traumatic spinal cord injury. The main findings were that the combined treatment of GH plus rehabilitation treatment is feasible and safe, and that GH but not placebo slightly improves the SCI individual motor score. Moreover, we found that an intensive and long-lasting rehabilitation program per se increases the functional outcome of SCI individuals. To understand the possible mechanisms of the improvement due to GH treatment (motor score) and due to rehabilitation (functional outcome), we used a proteomic approach. Here, we used a multiple proteomic strategy to search for recovery biomarkers in blood plasma with the potential to predict response to somatropin treatment and to delayed intensive rehabilitation. Forty-six patients were recruited and followed for a minimum period of 1 year. Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo. Both groups received rehabilitation treatment. Our strategy allowed us to perform one of the deepest plasma proteomic analyses thus far, which revealed two proteomic signatures with predictive value: (i) response to recombinant somatropin treatment and (ii) response to rehabilitation. The proteins implicated in these signatures are related to homeostasis, inflammation, and coagulation functions. These findings open novel possibilities to assess and therapeutically manage patients with SCI, which could have a positive impact on their clinical response.",2020,Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo.,"['incomplete chronic traumatic spinal cord injury', 'Forty-six patients were recruited and followed for a minimum period of 1 year', 'Incomplete Chronic Traumatic Spinal Cord Injury', 'spinal cord injury (SCI']","['rehabilitation treatment', 'recombinant somatropin', 'placebo', 'Growth Hormone Treatment and Rehabilitation', 'growth hormone (GH) treatment']","['SCI individual motor score', 'functional outcome']","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",46.0,0.0323718,Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Martin-Rojas', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sastre-Oliva', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Esclarín-Ruz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hospital Nacional de Parapléjicos, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Gil-Dones', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mourino-Alvarez', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Corbacho-Alonso', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno-Luna', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Hernandez-Fernandez', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Lopez', 'Affiliation': 'Unidad de Proteomica CNIC, 28029 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Oliviero', 'Affiliation': 'FENNSI Group, Hospital Nacional de Parapléjicos, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'María G', 'Initials': 'MG', 'LastName': 'Barderas', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}]",Journal of personalized medicine,['10.3390/jpm10040183']
1387,33096810,A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity.,"BACKGROUND


High protein calorie restriction diets have shown clinical efficacy for obesity, but the mechanisms are not fully known. The intestinal microbiome is a mediator of obesity and preclinical data support an effect of high protein diet (HPD) on the gut microbiome of obesity, but there are few studies in humans.
METHODS


To address this, we conducted a dietary intervention trial of 80 overweight and obese subjects who were randomized to a calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD) (15%) for 8 weeks. Baseline dietary intake patterns were assessed by the Diet History Questionnaire III. Longitudinal fecal sampling was performed at baseline, week 1, week 2, week 4, week 6, and week 8, for a total of 365 samples. Intestinal microbiome composition was assessed by 16S rRNA gene sequencing.
RESULTS


At baseline, microbial composition was associated with fiber and protein intake. Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD. The HPD was also associated with significant differences in microbial composition after treatment compared to the NPD. Both diets induced taxonomic shifts compared to baseline, including enrichment of  Akkermansia spp.  and  Bifidobacterium spp.  and depletion of  Prevotella spp.  Conclusion: These findings provide evidence that weight loss diets alter the gut microbiome in obesity and suggest differential effects of HPDs compared to NPDs which may influence the clinical response to HPD.",2020,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,['80 overweight and obese subjects'],['calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD'],"['Shannon index', 'microbial diversity', 'microbial composition', 'taxonomic shifts', 'Baseline dietary intake patterns', 'Intestinal microbiome composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0860902', 'cui_str': 'Protein NOS normal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",80.0,0.0173795,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,"[{'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Kayti', 'Initials': 'K', 'LastName': 'Luu', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Sedighian', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Shih-Lung', 'Initials': 'SL', 'LastName': 'Woo', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Dreskin', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Katzka', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Arias-Jayo', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ahdoot', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'UCLA Microbiome Center, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Pisegna', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}]",Nutrients,['10.3390/nu12103221']
1388,33096998,Fingerfoods: a feasibility study to enhance fruit and vegetable consumption in Dutch patients with dementia in a nursing home.,"BACKGROUND


Eating problems are highly prevalent in older patients with dementia and as a consequence, these patients are at greater risk of becoming malnourished. Fingerfoods, snacks that can be picked with thumb and forefinger, could be used to counteract malnutrition in patients with dementia. The aim of this feasibility study was to evaluate whether providing fruit and vegetable rich fingerfoods in the form of recognizable and familiar snacks on top of the normal intake was feasible for both patients with dementia and caregivers as a means to increase patients' nutritional status.
METHODS


Institutionalised patients with dementia (N = 15, 93% female, mean age = 85 years) were included in this feasibility study in the Netherlands. The residents received their regular diet supplemented with fingerfoods, comprising quiches and cakes rich in fruit or vegetables, for 6 weeks. Daily fingerfood consumption together with compensation behaviour at dinner of residents was administered with a checklist and food diaries at the start and end of the intervention as dose delivered. Furthermore, caregivers were asked to fill out a feedback form at the end of the intervention to measure fidelity and appreciation of the intervention.
RESULTS


Patients consumed on average 1.4 pieces (70 g) of fingerfoods daily, containing 41 g of fruit and/or vegetables. Fruit and vegetable consumption increased during the provision of the fingerfoods and the residents seemed not to compensate this intake during the rest of the day. The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
CONCLUSION


This feasibility study showed that providing recognizable fruit and vegetable rich fingerfoods to patients with dementia seems feasible for both patients and caregivers and could provide a pragmatic approach to enhance fruit and vegetable consumption and total food intake in institutionalized elderly. In an up-scaled study, effects of fingerfoods on nutritional status and quality of life should be investigated.",2020,"The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
","['patients with dementia', 'Institutionalised patients with dementia (N\u2009=\u200915, 93% female, mean age\u2009=\u200985\u2009years', ""patients with dementia and caregivers as a means to increase patients' nutritional status"", 'Dutch patients with dementia in a nursing home', 'institutionalized elderly', 'older patients with dementia']","['enhance fruit and vegetable consumption', 'regular diet supplemented with fingerfoods, comprising quiches and cakes rich in fruit or vegetables', 'recognizable fruit and vegetable rich fingerfoods', 'providing fruit and vegetable rich fingerfoods']","['Fruit and vegetable consumption', 'nutritional status and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453457', 'cui_str': 'Quiche'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0242008,"The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
","[{'ForeName': 'Annemijn', 'Initials': 'A', 'LastName': 'Visscher', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Marieke C E', 'Initials': 'MCE', 'LastName': 'Battjes-Fries', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands. m.battjes@louisbolk.nl.'}, {'ForeName': 'Ondine', 'Initials': 'O', 'LastName': 'van de Rest', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Patijn', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'van der Lee', 'Affiliation': 'ZuidOostZorg, Drachten, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Wijma-Idsinga', 'Affiliation': 'ZuidOostZorg, Drachten, The Netherlands.'}, {'ForeName': 'Gerda K', 'Initials': 'GK', 'LastName': 'Pot', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voshol', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01792-5']
1389,33096999,Correction to: Landmark-guided versus modified ultrasound-assisted Paramedian techniques in combined spinal-epidural anesthesia for elderly patients with hip fractures: a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['elderly patients with hip fractures'],"['combined spinal-epidural anesthesia', 'Landmark-guided versus modified ultrasound-assisted Paramedian techniques']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0490794,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Wuhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China. liliuyuhui@126.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01183-8']
1390,31228190,Genetic variation at the coronary artery disease risk locus GUCY1A3 modifies cardiovascular disease prevention effects of aspirin.,"AIMS


Efficacy of aspirin in primary prevention of cardiovascular disease (CVD) may be influenced by a common allele in guanylate cyclase GUCY1A3, which has been shown to modify platelet function and increase CVD risk.
METHODS AND RESULTS


We investigated whether homozygotes of the GUCY1A3 rs7692387 risk (G) allele benefited from aspirin in two long-term, randomized placebo-controlled trials of aspirin in primary CVD prevention: the Women's Genome Health Study (WGHS, N = 23 294) and a myocardial infarction (MI, N = 550) and stroke (N = 382) case-control set from the Physician's Health Study (PHS, N = 22 071). Bleeding risk was evaluated in the WGHS. In the placebo group of the WGHS, the GUCY1A3 risk (G) allele was confirmed to increase CVD risk [hazard ratio 1.38; 95% confidence interval (CI) 1.08-1.78; P = 0.01]. Random-effects meta-analysis of the WGHS and PHS revealed that aspirin reduced CVD events among risk allele homozygotes [G/G: odds ratio (OR) 0.79; 95% CI 0.65-0.97; P = 0.03] but increased CVD events among non-risk allele carriers (e.g. G/A: OR 1.39; 95% CI 1.03-1.87; P = 0.03) thus implying an interaction between genotype stratum and aspirin intake (Pinteraction = 0.01). Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
CONCLUSION


In two randomized placebo-controlled trials in the setting of primary prevention, aspirin reduced the incidence of CVD events in individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals had more events when taking aspirin.",2019,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","['individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals', ""primary CVD prevention: the Women's Genome Health Study (WGHS, N\u2009"", ""23\xa0294) and a myocardial infarction (MI, N\u2009=\u2009550) and stroke (N\u2009=\u2009382) case-control set from the Physician's Health Study (PHS, N\u2009=\u200922\xa0071""]","['placebo', 'aspirin']","['incidence of CVD events', 'CVD risk', 'CVD events', 'Bleeding risk']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C1519418', 'cui_str': 'GUCY1A3 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.283633,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","[{'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Passow', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Robert Y L', 'Initials': 'RYL', 'LastName': 'Zee', 'Affiliation': 'Department of Pediatric Dentistry, Tufts University School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz384']
1391,33085237,[Clinical effects of scaling and root planing with an adjunctive periodontal endoscope for residual pockets: a randomized controlled clinical study].,"OBJECTIVE


To evaluate the efficacy of scaling and root planing (SRP) with a periodontal endoscope in the treatment of residual pockets in patients with periodontitis after initial periodontal therapy.
METHODS


Patients with residual pockets [probing depth (PD)≥5 mm] were included and randomly assigned to the endoscope group (SRP with a periodontal endoscope) or SRP group (SRP alone). The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment. Data were analyzed with SPSS 20.0 software.
RESULTS


Compared with the baseline values, the percentage of PD≥5 mm sites, PD, AL, and BOP (+)% in the endoscope group and SRP group at 3 and 6 months after treatment decreased (P<0.05). Compared with the values at 3 months after treatment, the percentage of PD≥5 mm sites, PD, AL, and BOP (+)% at 3 and 6 months after treatment decreased in the endoscope group (P<0.05), whereas no statistical difference in these values was observed in the SRP group (P>0.05). Compared with those in the SRP group, the percentage of PD≥5 mm sites and PD at 3 and 6 months after treatment and AL and BOP (+)% at 6 months after treatment in the endoscope group decreased (P<0.05).
CONCLUSIONS


SRP with a periodontal endoscope shows a better effect in improving the PD, AL, and BOP of residual pockets (PD≥5 mm) in patients with periodontitis after initial periodontal therapy and has advantages in improving the long-term curative effect of this therapy.",2020,"The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment.","['residual pockets', 'patients with periodontitis', 'patients with periodontitis after initial periodontal therapy', 'Patients with residual pockets [probing depth (PD)≥5 mm']","['scaling and root planing', 'periodontal endoscope', 'endoscope group (SRP with a periodontal endoscope) or SRP group (SRP alone', 'scaling and root planing (SRP', 'adjunctive periodontal endoscope']","['PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets', 'percentage of PD≥5 mm sites and PD', 'percentage of PD≥5 mm sites, PD, AL, and BOP ']","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",,0.0303457,"The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment.","[{'ForeName': 'Yang-Heng', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Hou-Xuan', 'Initials': 'HX', 'LastName': 'Li', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Fu-Hua', 'Initials': 'FH', 'LastName': 'Yan', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Bao-Chun', 'Initials': 'BC', 'LastName': 'Tan', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}]",Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology,['10.7518/hxkq.2020.05.010']
1392,33079965,The effect of etidronate on choroidal neovascular activity in patients with pseudoxanthoma elasticum.,"AIM


To assess the effect of the bisphosphonate etidronate on choroidal neovascular (CNV) activity in patients with pseudoxanthoma elasticum (PXE).
METHODS


This is an ancillary study in a single center, randomized, double-blind placebo-controlled trial (RCT) in which 74 patients with PXE were assigned to either one-year etidronate or placebo treatment. Spectral domain optical coherence tomography (SD-OCT) imaging and color fundus photography were performed every three months for one year and were systematically assessed on signs of CNV activity.
RESULTS


In the etidronate group, 11 (30%) of the patients had CNV activity at baseline, compared to 25 (67%) of the patients in the placebo group (P = 0.005). The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168). Using a generalized mixed model for repeated measures, there was a protective effect of etidronate in crude analysis (RR 0.86, 95% CI 0.75-0.98) that disappeared when adjusting for baseline CNV activity (RR 0.97, 95% CI 0.84-1.13).
CONCLUSION


In this post-hoc RCT analysis we did not observe a protecting or deteriorating effect of etidronate on CNV activity in patients with PXE after adjustment for baseline CNV.",2020,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"['patients with pseudoxanthoma elasticum (PXE', 'patients with pseudoxanthoma elasticum', '74 patients with PXE']","['etidronate', 'placebo', 'bisphosphonate etidronate', 'etidronate or placebo']","['CNV activity', 'choroidal neovascular activity', 'improvement or worsening of CNV activity', 'choroidal neovascular (CNV) activity', 'proportion of eyes with CNV activity', 'baseline CNV activity ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033847', 'cui_str': 'Pseudoxanthoma elasticum'}]","[{'cui': 'C0086268', 'cui_str': 'Etidronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",74.0,0.315344,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Risseeuw', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'Imhof', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Willem P Th M', 'Initials': 'WPTM', 'LastName': 'Mali', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Spiering', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Ossewaarde-van Norel', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0240970']
1393,33079968,Predicting overdose among individuals prescribed opioids using routinely collected healthcare utilization data.,"INTRODUCTION


With increasing rates of opioid overdoses in the US, a surveillance tool to identify high-risk patients may help facilitate early intervention.
OBJECTIVE


To develop an algorithm to predict overdose using routinely-collected healthcare databases.
METHODS


Within a US commercial claims database (2011-2015), patients with ≥1 opioid prescription were identified. Patients were randomly allocated into the training (50%), validation (25%), or test set (25%). For each month of follow-up, pooled logistic regression was used to predict the odds of incident overdose in the next month based on patient history from the preceding 3-6 months (time-updated), using elastic net for variable selection. As secondary analyses, we explored whether using simpler models (few predictors, baseline only) or different analytic methods (random forest, traditional regression) influenced performance.
RESULTS


We identified 5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months). On average, patients who overdosed were younger and had more diagnoses and prescriptions. The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint). It outperformed simpler models based on few predictors (c-statistic 0.825, 95% CI 0.808-0.843) and baseline predictors only (c-statistic 0.806, 95% CI 0.787-0.26). Different analytic techniques did not substantially influence performance. In the final algorithm based on elastic net, the strongest predictors were age 18-25 years (OR: 2.21), prior suicide attempt (OR: 3.68), opioid dependence (OR: 3.14).
CONCLUSIONS


We demonstrate that sophisticated algorithms using healthcare databases can be predictive of overdose, creating opportunities for active monitoring and early intervention.",2020,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","['5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],[],2682.0,0.0579435,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","[{'ForeName': 'Jenny W', 'Initials': 'JW', 'LastName': 'Sun', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rough', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Hernández-Díaz', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Krista F', 'Initials': 'KF', 'LastName': 'Huybrechts', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Bateman', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}]",PloS one,['10.1371/journal.pone.0241083']
1394,33080005,Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.,"Importance


The coronavirus disease 2019 (COVID-19) pandemic is threatening billions of people worldwide. Tocilizumab has shown promising results in retrospective studies in patients with COVID-19 pneumonia with a good safety profile.
Objective


To evaluate the effect of early tocilizumab administration vs standard therapy in preventing clinical worsening in patients hospitalized with COVID-19 pneumonia.
Design, Setting, and Participants


Prospective, open-label, randomized clinical trial that randomized patients hospitalized between March 31 and June 11, 2020, with COVID-19 pneumonia to receive tocilizumab or standard of care in 24 hospitals in Italy. Cases of COVID-19 were confirmed by polymerase chain reaction method with nasopharyngeal swab. Eligibility criteria included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein.
Interventions


Patients in the experimental arm received intravenous tocilizumab within 8 hours from randomization (8 mg/kg up to a maximum of 800 mg), followed by a second dose after 12 hours. Patients in the control arm received supportive care following the protocols of each clinical center until clinical worsening and then could receive tocilizumab as a rescue therapy.
Main Outcome and Measures


The primary composite outcome was defined as entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2 ratio less than 150 mm Hg, whichever came first.
Results


A total of 126 patients were randomized (60 to the tocilizumab group; 66 to the control group). The median (interquartile range) age was 60.0 (53.0-72.0) years, and the majority of patients were male (77 of 126, 61.1%). Three patients withdrew from the study, leaving 123 patients available for the intention-to-treat analyses. Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86). Two patients in the experimental group and 1 in the control group died before 30 days from randomization, and 6 and 5 patients were intubated in the 2 groups, respectively. The trial was prematurely interrupted after an interim analysis for futility.
Conclusions and Relevance


In this randomized clinical trial of hospitalized adult patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg who received tocilizumab, no benefit on disease progression was observed compared with standard care. Further blinded, placebo-controlled randomized clinical trials are needed to confirm the results and to evaluate possible applications of tocilizumab in different stages of the disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT04346355; EudraCT Identifier: 2020-001386-37.",2020,"Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86).","['patients with COVID-19 pneumonia with a good safety profile', 'Eligibility criteria included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein', 'Patients Hospitalized With COVID-19 Pneumonia', 'patients hospitalized with COVID-19 pneumonia', 'A total of 126 patients', 'or standard of care in 24 hospitals in Italy', 'hospitalized adult patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg who received', 'patients hospitalized between March 31 and June 11, 2020, with COVID-19 pneumonia to receive']","['intravenous tocilizumab', 'supportive care', 'tocilizumab administration vs standard therapy', 'Tocilizumab vs Standard Care', 'Tocilizumab', 'placebo', 'tocilizumab']","['disease progression', 'entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2 ratio less', 'clinical worsening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",126.0,0.323061,"Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86).","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Salvarani', 'Affiliation': 'SOC Reumatologia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Dolci', 'Affiliation': 'Unità di Malattie Infettive, Università degli Studi di Modena e Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Massari', 'Affiliation': 'SOC Malattie Infettive, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Domenico Franco', 'Initials': 'DF', 'LastName': 'Merlo', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Cavuto', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Savoldi', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'SC Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Boni', 'Affiliation': 'SOC Internistica Multidisciplinare, Ospedale Civile Guastalla, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Turrà', 'Affiliation': 'SOC Farmacia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Pier Ferruccio', 'Initials': 'PF', 'LastName': 'Ballerini', 'Affiliation': 'UOC Medicina Generale Ospedale di Vittorio Veneto, Treviso, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sciascia', 'Affiliation': 'UOC Medicina Generale Ospedale di Vittorio Veneto, Treviso, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zammarchi', 'Affiliation': 'Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, SOD Malattie infettive e tropicali, AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Para', 'Affiliation': 'Medicina Interna 1, Dipartimento Emergenza ed Accettazione, AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Pier Giorgio', 'Initials': 'PG', 'LastName': 'Scotton', 'Affiliation': ""UO di Malattie Infettive, Ospedale Regionale Ca' Foncello di Treviso, Treviso, Italy.""}, {'ForeName': 'Walter Omar', 'Initials': 'WO', 'LastName': 'Inojosa', 'Affiliation': ""UO di Malattie Infettive, Ospedale Regionale Ca' Foncello di Treviso, Treviso, Italy.""}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Ravagnani', 'Affiliation': 'SSD Centro DH Allergologia e Immunologia Clinica, ASST-Mantova, Mantva, Italy.'}, {'ForeName': 'Nicola Duccio', 'Initials': 'ND', 'LastName': 'Salerno', 'Affiliation': 'UOC Malattie Infettive e Tropicali, AOUI di Verona, Verona, Italy.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Sainaghi', 'Affiliation': 'SS Reumatologia, SC Medicina Interna, DIMET, Università del Piemonte Orientale e AOU Maggiore della Carità di Novara.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Brignone', 'Affiliation': 'Reumatologia, Medicina Interna, Ospedale S. Andrea, La Spezia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Codeluppi', 'Affiliation': 'UOC Malattie Infettive, AUSL di Piacenza, Piacenza, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Teopompi', 'Affiliation': 'SOC Internistica Multidisciplinare, Ospedale Civile Guastalla, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Milesi', 'Affiliation': 'Unità di malattie Infettive, ASST di Cremona, Cremona, Italy.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Bertomoro', 'Affiliation': 'UOC Medicina Generale, ULSS6 Euganea Ospedali Riuniti Padova Sud, Padova, Italy.'}, {'ForeName': 'Norbiato', 'Initials': 'N', 'LastName': 'Claudio', 'Affiliation': 'SC Medicina Interna, AO Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salio', 'Affiliation': ""SC Malattie dell'Apparato Respiratorio, AO SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Falcone', 'Affiliation': 'Unità di Malattie Infettive, Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cenderello', 'Affiliation': 'SC Malattie Infettive, ASL1 Imperia, Impersia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Donghi', 'Affiliation': 'UO Malattie Infettive ed Epatologia, AOU Parma, Parma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Del Bono', 'Affiliation': 'Malattie Infettive e Tropicali, AO S. Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Paolo Luigi', 'Initials': 'PL', 'LastName': 'Colombelli', 'Affiliation': 'UO Medicina, Ospedale di Treviglio, ASST Bergamo Ovest, Bergamo, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Angheben', 'Affiliation': 'Dipartimento di Malattie Infettive, Tropicali e Microbiologia, IRCCS Ospedale Sacro Cuore-Don Calabria, Negrar di Valpolicella, Verona, Italy.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Passaro', 'Affiliation': 'Medicina Interna Universitaria, AOU Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Secondo', 'Affiliation': 'Medicina Interna, Ospedale Evangelico, Genoa, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Pascale', 'Affiliation': 'UO Malattie Infettive, Dipartimento di scienze mediche e chirurgiche, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Piazza', 'Affiliation': 'UOC Medicina Interna, AUSSS3 Serenissima, Dolo, Venezia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Facciolongo', 'Affiliation': 'SOC Pneumologia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Costantini', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.6615']
1395,33080017,Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial.,"Importance


Severe pneumonia with hyperinflammation and elevated interleukin-6 is a common presentation of coronavirus disease 2019 (COVID-19).
Objective


To determine whether tocilizumab (TCZ) improves outcomes of patients hospitalized with moderate-to-severe COVID-19 pneumonia.
Design, Setting, and Particpants


This cohort-embedded, investigator-initiated, multicenter, open-label, bayesian randomized clinical trial investigating patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days. Patients were recruited from 9 university hospitals in France. Analyses were performed on an intention-to-treat basis with no correction for multiplicity for secondary outcomes.
Interventions


Patients were randomly assigned to receive TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group). Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.
Main Outcomes and Measures


Primary outcomes were scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation) at day 14. Secondary outcomes were clinical status assessed with the WHO-CPS scores at day 7 and day 14, overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events.
Results


Of 131 patients, 64 patients were randomly assigned to the TCZ group and 67 to UC group; 1 patient in the TCZ group withdrew consent and was not included in the analysis. Of the 130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years. In the TCZ group, 12 patients had a WHO-CPS score greater than 5 at day 4 vs 19 in the UC group (median posterior absolute risk difference [ARD] -9.0%; 90% credible interval [CrI], -21.0 to 3.1), with a posterior probability of negative ARD of 89.0% not achieving the 95% predefined efficacy threshold. At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold. The HR for MV or death was 0.58 (90% CrI, 0.30 to 1.09). At day 28, 7 patients had died in the TCZ group and 8 in the UC group (adjusted HR, 0.92; 95% CI 0.33-2.53). Serious adverse events occurred in 20 (32%) patients in the TCZ group and 29 (43%) in the UC group (P = .21).
Conclusions and Relevance


In this randomized clinical trial of patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit, TCZ did not reduce WHO-CPS scores lower than 5 at day 4 but might have reduced the risk of NIV, MV, or death by day 14. No difference on day 28 mortality was found. Further studies are necessary for confirming these preliminary results.
Trial Registration


ClinicalTrials.gov Identifier: NCT04331808.",2020,"At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold.","['130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years', 'patients hospitalized with moderate-to-severe COVID-19 pneumonia', '64 patients', '131 patients', 'patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit', 'Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia', 'Patients were recruited from 9 university hospitals in France', 'patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days']","['antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants', 'Tocilizumab vs Usual Care', 'TCZ', 'tocilizumab (TCZ', 'TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group']","['overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events', 'HR for MV or death', 'WHO-CPS scores', 'day 28 mortality', 'clinical status assessed with the WHO-CPS scores', 'Serious adverse events', 'posterior probability of negative ARD', 'posterior probability of HR less', 'risk of NIV, MV, or death', 'scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation', 'noninvasive ventilation (NIV) or mechanical ventilation (MV) or died', 'WHO-CPS score']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",64.0,0.173704,"At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Hematology, Hôpital Necker, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Department of Rheumatology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, France.'}, {'ForeName': 'Pierre-Louis', 'Initials': 'PL', 'LastName': 'Tharaux', 'Affiliation': 'Paris Cardiovascular Center-PARCC, Université de Paris, INSERM, F-75015 Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'Université de Paris, ECSTRRA Team-CRESS-UMR 1153, INSERM, 75010, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), INSERM U1153, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': 'Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), INSERM U1153, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.6820']
1396,33080740,The effect of preoperative intravenous lidocaine on postoperative pain following hysteroscopy: A randomized controlled trial.,"BACKGROUND


The use of hysteroscopy for the diagnosis and treatment of uterine and endometrial abnormalities is often associated with postoperative pain. This randomized controlled trial aimed to assess the efficacy of preoperative intravenous (IV) lidocaine in reducing pain after hysteroscopy.
METHODS


In total, 138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea were randomly assigned to a control group (n = 69) or a lidocaine group (n = 69), which received normal saline or IV lidocaine at 1.5 mg/kg, respectively. The primary outcome was the incidence of postoperative pain.
RESULTS


The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001). The visual analog scale (0-10) score (median [interquartile range]) was lower in the IV lidocaine group than in the control group (0 [0-2]) vs 2 [0-4]), P < .001). The use of rescue analgesics and postoperative nausea and vomiting were similar between the 2 groups. This study demonstrated that administering 1.5 mg/kg of preoperative IV lidocaine can be a simple method to reduce incidence of pain after hysteroscopy.
CONCLUSION


Preoperative bolus administration of 1.5 mg/kg of IV lidocaine may be used to decrease incidence of pain after hysteroscopy under general anesthesia.",2020,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","['following hysteroscopy', '138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea']","['normal saline or IV lidocaine', 'preoperative intravenous (IV) lidocaine', 'lidocaine']","['visual analog scale', 'postoperative nausea and vomiting', 'incidence of pain', 'incidence of postoperative pain', 'postoperative pain', 'pain']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",138.0,0.190699,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Heungwoo', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Hyeon Chul', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}]",Medicine,['10.1097/MD.0000000000022751']
1397,33080746,Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial.,"BACKGROUND


To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) in early rehabilitation of patients with postoperative complications after cardiovascular surgery.
METHODS


37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study. Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent standard rehabilitation program only (non-NMES group). The primary outcome was the knee extensors strength at discharge in NMES group and in control. Secondary outcomes were the handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge.
RESULTS


Baseline characteristics were not different between the groups. Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45 [22.3; 33.1] kg on the left) than in the non-NMES group (22.3 [20.1; 27.1] and 22.5 [20.1; 25.9] kg, respectively; P < .001). Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge in the groups had no significant difference.
CONCLUSIONS


This pilot study shows a beneficial effect of NMES on muscle strength in patients with complications after cardiovascular surgery. The use of NMES showed no effect on strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge.Further blind randomized controlled trials should be performed with emphasis on the effectiveness of NEMS in increasing muscle strength and structure in these patients.",2020,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"['37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study', 'Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent', 'patients with complications after cardiovascular surgery', 'patients with postoperative complications after cardiovascular surgery']","['NMES', 'Neuromuscular electrical stimulation', 'neuromuscular electrical stimulation (NMES', 'NEMS', 'standard rehabilitation program']","['handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge', 'muscle strength', 'Knee extensors strength at discharge', 'strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge', 'Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge', 'knee extensors strength at discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",18.0,0.182019,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"[{'ForeName': 'Alexey Nikolaevich', 'Initials': 'AN', 'LastName': 'Sumin', 'Affiliation': ''}, {'ForeName': 'Pavel Alexandrovich', 'Initials': 'PA', 'LastName': 'Oleinik', 'Affiliation': ''}, {'ForeName': 'Andrey Viktorovich', 'Initials': 'AV', 'LastName': 'Bezdenezhnykh', 'Affiliation': ''}, {'ForeName': 'Anna Valeryvena', 'Initials': 'AV', 'LastName': 'Ivanova', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022769']
1398,33080765,Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study.,"OBJECTIVES


The Thrower's Ten Exercise program is an exercise program especially designed to improve the strength, power and endurance of the shoulder complex. The aim of this study was to investigate the effects of the Thrower's Ten exercises on the upper extremity performance in healthy sedentary individuals.
METHODS


36 healthy sedentary individuals completed this study conducted with a randomized controlled design. The subjects were divided into 2 groups: exercise and control. The exercise group received a training of the Thrower's Ten exercises of 50-minute sessions 3 times a week for a duration of 8 weeks. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder internal and external rotator muscles was measured with an isokinetic dynamometer at a speed of 60°/second. The study was registered on the Clinical Trials website by the number NCT04162886.
RESULTS


A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05). On the other hand, comparisons of the dynamic equilibrium, explosive power and isokinetic muscle strength parameters within the exercise group returned statistically different results (P < .05).
CONCLUSIONS


The Thrower's Ten exercises represent an effective method to improve the balance on the upper extremity, explosive power and isokinetic strength in healthy sedentary individuals.",2020,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","['healthy sedentary individuals', '36 healthy sedentary individuals']",['exercise and control'],"['dynamic balance and explosive power', 'dynamic equilibrium, explosive power and isokinetic muscle strength parameters', 'upper extremity performance', 'strength of the shoulder internal and external rotator muscles', 'isokinetic muscle strength and body composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0224320', 'cui_str': 'Structure of rotator muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",36.0,0.0170843,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Gokalp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, 99628, via Mersin-10, Turkey.'}, {'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022837']
1399,33080806,Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity.,"Abnormal levels of pyruvate and lactate were reported in multiple sclerosis (MS). We studied the response of markers of mitochondrial function to rehabilitation in relation to type, intensity and endurance performance in severely disabled MS patients. Forty-six progressive MS patients were randomized to receive 12 walking sessions of robot-assisted gait training (RAGT,  n  = 23) or conventional overground therapy (CT,  n  = 23). Ten healthy subjects were also studied. Blood samples were collected to determine lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation. In vivo muscle metabolism and endurance walking capacity were assessed by resting muscle oxygen consumption (rmVO 2 ) using near-infrared spectroscopy and by six-minute walking distance (6MWD), respectively. The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population. In the two groups, an enhanced response was observed after RAGT compared to CT for lactate ( p  = 0.012), glutathione (<0.001), lactate/pyruvate ratio ( p  = 0.08) and rmVO 2  ( p  = 0.07). Metabolic biomarkers and 6MWD improvements were exclusively correlated with a training speed markedly below individual gait speed. In severely disabled MS patients, rehabilitation rebalanced altered serum metabolic and muscle parameters, with RAGT being more effective than CT. A determinable slow training speed was associated with better metabolic and functional recovery. Trial Registration: ClinicalTrials.gov NCT02421731.",2020,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","['Progressive Multiple Sclerosis', 'Ten healthy subjects', 'Forty-six progressive MS patients', 'severely disabled MS patients']","['12 walking sessions of robot-assisted gait training (RAGT,  n  = 23) or conventional overground therapy', 'Robot-Assisted Gait Training', 'Rehabilitation']","['lactate/pyruvate ratio', 'metabolic and functional recovery', 'lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation', 'Metabolic biomarkers and 6MWD improvements', 'Abnormal levels of pyruvate and lactate', 'enhanced response']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0428617', 'cui_str': 'Lactate/pyruvate ratio measurement'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.0175828,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Patergnani', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bonora', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pinton', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10100834']
1400,33081444,[Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study].,"OBJECTIVE


To evaluate the efficacy and safety of tenoten for children in the treatment of specific developmental disorders of academic skills in children of 1-3 grades.
MATERIAL AND METHODS


Two hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests; 5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children) were enrolled in the study. CT was conducted in 10 clinical centers in Russian Federation in 2015- 2019. Patients were randomized into two groups. The first one ( n =122) received tenoten for children in a dose of 1 tablet 3 times a day, the second one ( n =118) was administered placebo in the same dosage regimen. The clinical data on 237 children (121 of the tenoten group and 116 of the placebo group) were used for Intention-to-treat efficacy analysis. Data on 220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis. The duration of study was 12 weeks. The mean total academic skills (reading, spelling, and counting) score in groups after 12 weeks of treatment was set as the primary efficacy endpoint.
RESULTS


The mean total academic skills score increased by 18.55±15.87 points. The significant total difference between the median changes in the total score in the tenoten and placebo groups was 5 points. There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples. There were 73 adverse events (AEs) in 42 patients of the tenoten group and 95 AEs in 31 children of the placebo group. No serious or severe AEs were registered in the tenoten group. No AEs definitely related to the study treatment were registered. No negative drug interactions were observed in the tenoten group.
CONCLUSIONS


Tenoten for children is an effective and safe treatment for specific developmental disorders of academic skills in primary school children. Tenoten for children is well tolerated. The treatment is characterized by a high level of adherence of children and their parents to therapy.",2020,There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples.,"['10 clinical centers in Russian Federation in 2015- 2019', '237 children (121 of the tenoten group and 116 of the', 'Two hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests', 'children of 1-3 grades', 'primary school children', 'children', '220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis', '5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children']","['CT', 'placebo']","['mean total academic skills score', 'total score', 'efficacy and safety', 'serious or severe AEs', 'negative drug interactions', 'tolerated', 'mean total academic skills (reading, spelling, and counting) score']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2354538', 'cui_str': 'tenoten'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037789', 'cui_str': 'Specific reading disorder'}, {'cui': 'C0349326', 'cui_str': 'Specific spelling disorder'}, {'cui': 'C0494427', 'cui_str': 'Specific disorder of arithmetical skills'}, {'cui': 'C0349327', 'cui_str': 'Mixed disorder of scholastic skills'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033905', 'cui_str': 'Psychologic test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",237.0,0.109164,There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples.,"[{'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Zavadenko', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Skripchenko', 'Affiliation': ""Scientific Research Institute of Children's Infections of the Federal Medical and Biological Agency, St. Petersburg, Russia.""}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Gaynetdinova', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Khaletskaya', 'Affiliation': 'Privolzhsky Research Medical University, Nizhniy Novgorod, Russia.'}, {'ForeName': 'O B', 'Initials': 'OB', 'LastName': 'Doronina', 'Affiliation': 'Novosibirsk State Medical University, Novosibirsk, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Suvorinova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'E Sh', 'Initials': 'ES', 'LastName': 'Sagautdinova', 'Affiliation': ""Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center Bonum, Ekaterinburg, Russia.""}, {'ForeName': 'Yu O', 'Initials': 'YO', 'LastName': 'Boychevskaya', 'Affiliation': 'Specialized Clinical Psychiatric Hospital No. 1 of the Ministry of Health of the Krasnodar Region, Krasnodar, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Panteleeva', 'Affiliation': 'Moscow Regional Research and Clinical Institute («MONIKI»), Moscow, Russia.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Teplyakova', 'Affiliation': ""«Children's city polyclinic No. 4» of Rostov-on-Don, Rostov-on-Don, Russia.""}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Antonova', 'Affiliation': ""St. Petersburg «Children's city clinic No. 35», St. Petersburg, Russia.""}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009128']
1401,33081449,[The double-blind randomized placebo-controlled trial of N-acetylcysteine use in schizophrenia: preliminary results].,"BACKGROUND


Currently, oxidative stress as part of the pathogenesis of schizophrenia attracts much attention. In this regard, it becomes relevant to assess the level of redox imbalance in patients with schizophrenia, its impact on existing symptoms and the possibility of its treatment. The antioxidant N-acetylcysteine is one of the potential drugs that affects oxidative stress.
OBJECTIVE


To study the possibilities of the use of N-acetylcysteine in patients with schizophrenia.
MATERIAL AND METHODS


The study included 20 patients diagnosed with paranoid schizophrenia with the disease duration of less than 3 years, randomly assigned to the main group (taking N-acetylcysteine at a dose of 2000 mg per day for 60 days) and a comparison group (placebo) in a double-blinded manner. At the beginning and end of the study, cognitive functions were evaluated using the specialized instrument BACS, the severity of psychopathological symptoms was evaluated using PANSS, and blood was collected to determine the level of glutathione (GSH), which is a metabolite of N-acetylcysteine.
RESULTS


There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group. Compared with the comparison group, the dynamics of the negative PANSS score ( p =0.005) and the general psychopathology PANSS score ( p =0.004) was significantly different. When assessing the dynamics of cognitive functions in the main group, a significant improvement in indicators was established in the task for a sequence of numbers that characterizes working memory ( p =0.037). The level of GSH significantly increased in the main group ( p =0.01), however, there were no statistically significant differences between groups at the final visit.
CONCLUSION


N-acetylcysteine has a positive effect on the negative, general psychopathology PANSS scores, some cognitive functions, in particular, working memory, that allows considering this drug as a promising method of augmentation of schizophrenia therapy and requires further attentive study.",2020,"There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group.","['20 patients diagnosed with paranoid schizophrenia with the disease duration of less than 3 years', 'patients with schizophrenia', 'schizophrenia']","['N-acetylcysteine', 'placebo', 'main group (taking N-acetylcysteine at a dose of 2000 mg per day for 60 days) and a comparison group (placebo', 'antioxidant N-acetylcysteine']","['negative PANSS score', 'level of GSH', 'general psychopathology PANSS score', 'positive PANSS score', 'general pathology PANSS score', 'dynamics of cognitive functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036349', 'cui_str': 'Paranoid schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0420637', 'cui_str': 'General pathology'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",20.0,0.0952515,"There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Pyatoykina', 'Affiliation': 'Clinical Psychiatric Hospital No. 1, Nizhny Novgorod, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Zhilyaeva', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Semennov', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Mishanov', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Blagonravova', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Mazo', 'Affiliation': 'Bekhterev National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009166']
1402,32915063,Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.,"BACKGROUND


In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system.
METHODS


A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature.
RESULTS


The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost.
CONCLUSIONS


The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.",2020,"The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection.","['6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant']",['antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone'],"['Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates', 'Costs and quality-adjusted life years', 'mortality, life expectancy, and infection cost', 'Life expectancy and long-term costs', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}]","[{'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",6983.0,0.0976023,"The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection.","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'University of Modena and Reggio Emilia, Modena, Italy (G.B.).'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System, Ridgewood, NJ (S.M.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington School of Medicine, Seattle (J.E.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'Sahlgrenska University Hospital, Göteborg, Sweden (C.K.).'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.R.C.).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krahn', 'Affiliation': 'University of British Colombia, Canada (A.D.K.).'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Schloss', 'Affiliation': 'The Christ Hospital, Cincinnati, OH (E.J.S.).'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gallastegui', 'Affiliation': 'Clearwater Cardiovascular and Interventional Consultants, Safety Harbor, FL (J.L.G.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Pickett', 'Affiliation': 'Saint Thomas Research Institute, LLC, Nashville, TN (R.A.P.).'}, {'ForeName': 'Rudolph F', 'Initials': 'RF', 'LastName': 'Evonich', 'Affiliation': 'Upper Michigan Cardiovascular Associates, Marquette (R.F.E.).'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Roark', 'Affiliation': 'Cardiology Associates of Gainesville, FL (S.F.R.).'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sorrentino', 'Affiliation': 'Iowa Heart Center, Ames (D.M.S.).'}, {'ForeName': 'Darius P', 'Initials': 'DP', 'LastName': 'Sholevar', 'Affiliation': 'Virtua Health System, Camden, NJ (D.P.S.).'}, {'ForeName': 'Edmond M', 'Initials': 'EM', 'LastName': 'Cronin', 'Affiliation': 'Temple University Hospital, Philadelphia, PA (E.M.C.).'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Berman', 'Affiliation': 'Chula Vista Cardiac Center, CA (B.J.B.).'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Riggio', 'Affiliation': 'Arizona Arrhythmia Consultants, Scottsdale (D.W.R.).'}, {'ForeName': 'Hafiza H', 'Initials': 'HH', 'LastName': 'Khan', 'Affiliation': 'Baylor Research Institute, Plano, TX (H.H.K.).'}, {'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Silver', 'Affiliation': 'WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh, NC (M.T.S.).'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'Oklahoma Heart Hospital (J.C.).'}, {'ForeName': 'Zayd', 'Initials': 'Z', 'LastName': 'Eldadah', 'Affiliation': 'MedStar Heart and Vascular Institute, Washington, DC (Z.E.).'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Cleveland Clinic, OH (B.L.W., K.G.T.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008503']
1403,33097092,Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.,"BACKGROUND


When chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients.
METHODS


A total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety.
RESULTS


No differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively.
CONCLUSION


Adding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005-000490-21. Registered September 2005.",2020,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","['patients with early breast cancer', 'patients with high-risk early breast cancer', 'patients with metastatic breast cancer', 'high-risk early breast cancer patients', '3754 patients with at least one of the following characteristics']","['5-fluorouracil, epirubicin, and cyclophosphamide', 'gemcitabine', 'docetaxel and gemcitabine (FEC\u2009→\u2009Doc/Gem', 'docetaxel (FEC\u2009→\u2009Doc', 'Gemcitabine', 'EudraCT']","['disease-free survival (DFS', '5-year probabilities of DFS', '5-year probabilities of OS', '5-year DFS or OS', 'hazard ratio', 'overall survival (OS) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0011710', 'cui_str': 'desoxycorticosterone'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3754.0,0.130094,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","[{'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany. amelie.degregorio@uniklinik-ulm.de.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Häberle', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, University Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Schrader', 'Affiliation': 'Gynecologic-Oncological Practice, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': 'Gynecologic Practice Dr. Lorenz, N. Hecker, Dr. Kreiss-Sender, Braunschweig, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Hemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Bauer', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Deniz', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Visnja', 'Initials': 'V', 'LastName': 'Fink', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Andergassen', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Division of Gynecologic Oncology and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Department of Oncology, Onkologie Bethanien, Frankfurt, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': 'Department of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Department of Gynecology and Breast Center, Charité University Hospital Campus Charité-Mitte, Berlin, Germany.'}, {'ForeName': 'Tanja N', 'Initials': 'TN', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Heinrich', 'Affiliation': 'Department of Gynecologic Oncology, Schwerpunktpraxis für Gynäkologische Onkologie, Fürstenwalde, Germany.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Lato', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01348-w']
1404,33097097,NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol.,"BACKGROUND


Substance use disorders (SUDs) lead to tens-of-thousands of overdose deaths and other forms of preventable deaths in the USA each year. This results in over $500 billion per year in societal and economic costs as well as a considerable amount of grief for loved ones of affected individuals. Despite these health and societal consequences, only a small percentage of people seek treatment for SUDs, and the majority of those that seek help fail to achieve long-term sobriety. E-health applications in healthcare have proven to be effective at sustaining treatment and reaching patients traditional treatment pathways would have missed. However, e-health adoption and sustainment rates in healthcare are poor, especially in the SUD treatment sector. Implementation engineering can address this gap in the e-health field by augmenting existing implementation models, which explain organizational and individual e-health behaviors retrospectively, with prospective resources that can guide implementation.
METHODS


This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment. The proposed e-health implementation model is the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework. This project, based in Iowa, will compare a control condition (using a typical software product training approach that includes in-person staff training followed by access to on-line support) to software implementation utilizing NIATx-TI, which includes change management training, followed by coaching on how to implement and use the mobile application. While e-health spans many modalities and health disciplines, this project will focus on implementing the Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app framework. This trial will be conducted in Iowa at 46 organizational sites within 12 SUD treatment agencies. The control arm consists of 23 individual treatment sites based at five organizations, and the intervention arm consists of 23 individual SUD treatment sites based at seven organizations DISCUSSION: This study addresses an issue of substantial public health significance: enhancing the uptake of the growing inventory of patient-centered evidence-based addiction treatment e-health technologies.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03954184 . Posted 17 May 2019.",2020,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,['Iowa at 46 organizational sites within 12 SUD treatment agencies'],['NIATx-TI versus typical product training'],[],"[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0436354,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,"[{'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'White', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA. vmwhite@wisc.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Molfenter', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Horst', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Greller', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Educational Sciences, 1025 West Johnson St, Madison, WI, 53706-1706, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': 'Division of Behavioral Health, Iowa Department of Public Health, Lucas State Office Building, 321 E. 12th Street, Des Moines, IA, 50319-0075, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Cody', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Praan', 'Initials': 'P', 'LastName': 'Pisitthakarm', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Toy', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01053-4']
1405,33098382,The Effect of N-Acetyl-Cysteine on  NRF2  Antioxidant Gene Expression in Asthenoteratozoospermia Men: A Clinical Trial Study.,"Background


One of the important factor associated with male infertility is high production of reactive oxygen species (ROS). The main function of Nuclear factor erythroid 2-related factor 2 ( NRF2 ) is to activate the cellular antioxidant response by inducing the transcription of a wide array of genes that can combat the harmful effects of factors such as oxidative stress. The purpose of this study was to evaluate the effect of N-acetyl-L-cysteine (NAC), as an antioxidant drug, on NRF2 Gene Expression in Asthenoteratozoospermia Men.
Materials and Methods


In this randomized, blinded clinical trial study, included 50 infertile men with asthenoteratozoospermia, who received NAC (600 mg, three times daily). Sperm parameters analyzed according to the world health organization (WHO; 2010). Sperm DNA fragmentation, relative  NRF2  expression, and seminal plasma level of antioxidant enzymes were measured by TUNEL assay, reverse transcription polymerase chain reaction (RT-PCR) and ELISA test, respectively.
Results


After NAC treatment, findings showed a significant increase in sperm concentration and motility compared to pre-treatment status, whereas the percentage of abnormal morphology and DNA fragmentation was significantly decreased (P<0.05). A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05). Significant correlations were observed between NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes (P<0.05).
Conclusion


The results demonstrated that NAC oral supplementation protected against oxidative stress by enhancing NRF2 expression. This could improve semen parameters quality parameters in asthenoteratozoospermia men (Registration number: IRCT20170830035998N4).",2020,A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"['Asthenoteratozoospermia Men', '50 infertile men with asthenoteratozoospermia, who received']","['N-Acetyl-Cysteine', 'NAC', 'N-acetyl-L-cysteine (NAC']","['expression of  NRF2  gene and antioxidant enzyme levels', 'oxidative stress', 'NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes', 'Antioxidant Gene Expression', 'Sperm DNA fragmentation, relative  NRF2  expression, and seminal plasma level of antioxidant enzymes', 'sperm concentration and motility', 'percentage of abnormal morphology and DNA fragmentation']","[{'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",50.0,0.128508,A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"[{'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Jannatifar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Parivar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Hayati Roodbari', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran. Electronic Address: mh.nasr-esfahani@royaninstitute.org.'}]",International journal of fertility & sterility,['10.22074/ijfs.2020.44411']
1406,33098800,Effects of intensive versus standard blood pressure control on domain-specific cognitive function: a substudy of the SPRINT randomised controlled trial.,"BACKGROUND


Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT.
METHODS


SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062.
FINDINGS


From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7-5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of -0·005 (95% CI -0·010 to 0·001) in the intensive treatment group and -0·001 (-0·006 to 0·005) in the standard treatment group (between-group difference -0·004, 95% CI -0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015 (-0·021 to 0·009) for the standard treatment group.
INTERPRETATION


Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains.
FUNDING


National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.",2020,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","['2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment', 'Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia', 'participants from SPRINT', '102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico', 'participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment', 'intensive lowering of systolic blood pressure', 'intensive versus standard blood pressure control']","['standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding', 'Mean standardised processing speed domain scores', 'domain-specific cognitive function', 'systolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4517680', 'cui_str': '2800'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",2921.0,0.271982,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: srapp@wakehealth.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chelune', 'Affiliation': 'Department of Neurology, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Wilson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Whittle', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Medical Center, Bedford, MA, USA; Department of Public Health, University of Massachusetts Lowell, Lowell, MA, USA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Medicine, Tulane University, New Orleans, LA, USA; Department of Epidemiology, Tulane University, New Orleans, LA, USA; Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martindale-Adams', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Eliza C', 'Initials': 'EC', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology-Hypertension, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joni K', 'Initials': 'JK', 'LastName': 'Snyder', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Affairs Healthcare System, Miami, FL, USA; Division of Population Health and Computational Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Wolfgram', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Maryjo L', 'Initials': 'ML', 'LastName': 'Cleveland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Nichols', 'Affiliation': 'Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Robert Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas, Austin, TX, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30319-7']
1407,33098862,Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial.,,2020,,['Children by'],['Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0429551,,"[{'ForeName': 'Vesna D', 'Initials': 'VD', 'LastName': 'Zivkovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia. Electronic address: petvesna67@gmail.com.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Stankovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Dimitrijevic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Zlatanovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Savic', 'Affiliation': 'College of Health Studies Cuprija, Cuprija, Serbia.'}]",Urology,['10.1016/j.urology.2020.10.012']
1408,33099278,Prevention and treatment of pulmonary congestion in patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock.,"Cardiogenic shock is still a major driver of mortality on intensive care units and complicates ∼10% of acute coronary syndromes with contemporary mortality rates up to 50%. In the meantime, percutaneous circulatory support devices, in particular venoarterial extracorporeal membrane oxygenation (VA-ECMO), have emerged as an established salvage intervention for patients in cardiogenic shock. Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making. In this critical care perspective, we provide a concise overview of VA-ECMO utilization in cardiogenic shock, considering rationale, critical care management, as well as weaning aspects. We supplement previous literature by focusing on therapeutic issues related to the vicious circle of retrograde aortic VA-ECMO flow, increased left ventricular (LV) afterload, insufficient LV unloading, and severe pulmonary congestion limiting prognosis in a relevant proportion of patients receiving VA-ECMO treatment. We will outline different modifications in percutaneous mechanical circulatory support to meet this challenge. Besides a strategy of running ECMO at lowest possible flow rates, novel therapeutic options including the combination of VA-ECMO with percutaneous microaxial pumps or implementation of a venoarteriovenous-ECMO configuration based on an additional venous cannula supplying towards pulmonary circulation are most promising among LV unloading and venting strategies. The latter may even combine the advantages of venovenous and venoarterial ECMO therapy, providing potent respiratory and circulatory support at the same time. However, whether VA-ECMO can reduce mortality has to be evaluated in the urgently needed, ongoing prospective randomized studies EURO-SHOCK (NCT03813134), ANCHOR (NCT04184635), and ECLS-SHOCK (NCT03637205). These studies will provide the opportunity to investigate indication, mode, and effect of LV unloading in dedicated sub-analyses. In future, the Heart Teams should aim at conducting a dedicated randomized trial comparing VA-ECMO support with vs. without LV unloading strategies in patients with cardiogenic shock.",2020,"Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making.","['patients in cardiogenic shock', 'patients with cardiogenic shock', 'patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock']","['venovenous and venoarterial ECMO therapy', 'Venoarterial extracorporeal membrane oxygenation', 'VA-ECMO']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}]","[{'cui': 'C0391895', 'cui_str': 'Venovenous'}, {'cui': 'C0450124', 'cui_str': 'Venoarterial'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}]",[],,0.0966445,"Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Lüsebrink', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Kupka', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Scherer', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hagl', 'Affiliation': 'Herzchirurgische Klinik und Poliklinik, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zimmer', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Sigmund-Freud-Straße 25, 53127 Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Luedike', 'Affiliation': 'Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig Heart Institute, Strümpellstraße 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'Klinik für Allgemeine und Interventionelle Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20251 Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schäfer', 'Affiliation': 'Klinik für Kardiologie und Angiologie, Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa547']
1409,33099871,"Reply to comment on ""Preoperative Intravenous Iron Therapy and Survival after Colorectal Cancer Surgery: Long Term Results from the IVICA Randomised Controlled Trial"".",We would like to thank Mr McSorley et al for their insightful letter regarding our recent study investigating the long term outcomes of colorectal cancer patients who have received preoperative intravenous (IV) iron for their anaemia (1).,2020,We would like to thank Mr McSorley et al for their insightful letter regarding our recent study investigating the long term outcomes of colorectal cancer patients who have received preoperative intravenous (IV) iron for their anaemia (1).,"['Colorectal Cancer Surgery', 'colorectal cancer patients who have received preoperative intravenous (IV) iron for their anaemia (1']",[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]",[],[],,0.102926,We would like to thank Mr McSorley et al for their insightful letter regarding our recent study investigating the long term outcomes of colorectal cancer patients who have received preoperative intravenous (IV) iron for their anaemia (1).,"[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Dickson', 'Affiliation': 'National Institute for Health Research Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust.'}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Keeler', 'Affiliation': 'Milton Keynes University Hospitals NHS Foundation Trust.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ng', 'Affiliation': 'University of Nottingham, Department of Colorectal Surgery, Nottingham University Hospitals NHS Trust, Nottingham.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastroenterology, Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Brookes', 'Affiliation': 'Department of Gastroenterology, Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Acheson', 'Affiliation': 'National Institute for Health Research Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15414']
1410,33099898,nal-IRI+5-FU/LV versus 5-FU/LV in post-gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese patients.,"BACKGROUND


In the NAPOLI-1 phase 3 trial, liposomal irinotecan (nal-IRI) +5-fluorouracil/leucovorin (5-FU/LV) significantly increased mPFS versus 5-FU/LV (3.1 vs. 1.5 months [unstratified HR = 0.56, p = 0.0001]) in patients with mPAC that progressed on prior gemcitabine-based therapy. This randomized phase 2 trial evaluated nal-IRI+5-FU/LV tolerability (Part 1), safety, and efficacy (Part 2; outcomes reported here) in Japanese patients with mPAC that progressed on gemcitabine-based therapy.
METHODS


Patients were randomized 1:1 and stratified by KPS (70 and 80 vs. ≥90) and baseline albumin (≥4.0 g/dl vs. <4.0 g/dl). Primary endpoint was PFS; secondary endpoints were ORR, DCR, OS, TTF, CA19-9 response, and QoL. The ITT population comprised all randomized patients.
RESULTS


Patient characteristics differed between nal-IRI+5-FU/LV (n = 40) and 5-FU/LV (n = 39) arms, including baseline hepatic lesions (63% vs. 51%), stage IV disease at diagnosis (78% vs. 51%), and post-study anticancer therapy (55% vs. 72%). Investigator-assessed mPFS increase with nal-IRI+5-FU/LV was clinically meaningful and statistically significant versus 5-FU/LV (2.7 vs. 1.5 months, HR = 0.60). Independently assessed mPFS showed similar trends (1.7 vs. 1.6 months, HR = 0.79). mOS was 6.3 months with nal-IRI+5-FU/LV and not reached with 5-FU/LV. ORR increased significantly with nal-IRI+5-FU/LV versus 5-FU/LV (18% vs. 0, rate difference 17.5). Commonly reported grade ≥3 treatment-emergent AEs were decreased neutrophil count (37% vs. 3%), decreased white blood cell count (20% vs. 0), and diarrhea (17% vs. 3%).
CONCLUSIONS


In conclusion, clinically meaningful and statistically significant gains in investigator-assessed PFS and ORR were observed with nal-IRI+5-FU/LV versus 5-FU/LV in Japanese patients, with no new or unexpected safety signals. (Clinicaltrials.gov ID: NCT02697058).",2020,"Investigator-assessed mPFS increase with nal-IRI+5-FU/LV was clinically meaningful and statistically significant versus 5-FU/LV (2.7 vs. 1.5 months, HR = 0.60).","['post-gemcitabine metastatic pancreatic cancer', 'Japanese patients with mPAC that progressed on gemcitabine-based therapy', 'Patients', 'Japanese patients']","['5-FU/LV', 'KPS', 'nal-IRI+5-FU/LV versus 5-FU/LV', 'liposomal irinotecan (nal-IRI)\xa0+5-fluorouracil/leucovorin (5-FU/LV']","['stage IV disease at diagnosis', 'diarrhea', 'nal-IRI+5-FU/LV tolerability (Part 1), safety, and efficacy', 'neutrophil count', 'investigator-assessed PFS and ORR', 'ORR', 'white blood cell count', 'baseline hepatic lesions', 'ORR, DCR, OS, TTF, CA19-9 response, and QoL']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C4057931', 'cui_str': 'irinotecan liposomal'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0652896,"Investigator-assessed mPFS increase with nal-IRI+5-FU/LV was clinically meaningful and statistically significant versus 5-FU/LV (2.7 vs. 1.5 months, HR = 0.60).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Nakamori', 'Affiliation': 'Department of Surgery, NHO Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Sugimori', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Yokohama-shi, Kanagawa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kanai', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ozaka', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'Department of Hepatic-biliary-pancreatology, NHO Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kawabe', 'Affiliation': 'Department of Medicine and Bioregulatory Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Faculty of Medicine, Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Hokkaido, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research Center, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Department of Oncology, Hirosaki University Hospital, Aomori, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Chugh', 'Affiliation': 'Servier Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Servier Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ioka', 'Affiliation': 'Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}]",Cancer medicine,['10.1002/cam4.3558']
1411,33099909,Fast-track surgery in single-hole thoracoscopic radical resection of lung cancer.,"PURPOSE


To explore the efficacy and safety of fast-track surgery (FTS) in the perioperative period of single-hole thoracoscopic radical resection of lung cancer.
METHODS


The clinical data of 152 lung cancer patients undergoing single-hole thoracoscopic radical resection of lung cancer in our hospital from October 2016 to March 2019 were collected. Among them, 76 patients were treated with perioperative FTS (FTS group) following in-depth information and education, effective analgesia, early ambulation and early extubation, while the other 76 patients received conventional perioperative treatments (Control group).
RESULTS


The intraoperative volumes of blood loss and fluid infusion in FTS group were smaller than those in Control group. Moreover, the mean time to postoperative drainage tube removal, time to the first postoperative ambulation and length of postoperative hospital stay in FTS group were substantially shorter than those in Control group. Moreover, the visual analog scale (VAS) scores of patients at 48 and 72 h after operation in FTS group were considerably lower than those in Control group. Besides, the total incidence rate of postoperative complications in FTS group was considerably lower than that in Control group. Compared with those before operation, all pulmonary function indicators declined substantially after operation, and the postoperative forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and maximum voluntary ventilation (MVV) in FTS group were remarkably higher than those in Control group.
CONCLUSION


FTS in the perioperative period of single-hole thoracoscopic radical resection of lung cancer can effectively accelerate the recovery of patients, alleviate their pain, shorten the length of hospital stay, reduce hospitalization expense and improve patient's satisfaction, so it is worth clinically applying.",2020,"FTS in the perioperative period of single-hole thoracoscopic radical resection of lung cancer can effectively accelerate the recovery of patients, alleviate their pain, shorten the length of hospital stay, reduce hospitalization expense and improve patient's satisfaction, so it is worth clinically applying.","['152 lung cancer patients undergoing', 'single-hole thoracoscopic radical resection of lung cancer', '76 patients were treated with', 'of lung cancer in our hospital from October 2016 to March 2019 were collected']","['FTS', 'fast-track surgery (FTS', 'Fast-track surgery', 'single-hole thoracoscopic radical resection', 'conventional perioperative treatments (Control group', 'perioperative FTS (FTS']","['mean time to postoperative drainage tube removal, time to the first postoperative ambulation and length of postoperative hospital stay', 'postoperative forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and maximum voluntary ventilation (MVV', 'pulmonary function indicators', 'efficacy and safety', 'total incidence rate of postoperative complications', 'intraoperative volumes of blood loss and fluid infusion', 'visual analog scale (VAS) scores']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",76.0,0.0217764,"FTS in the perioperative period of single-hole thoracoscopic radical resection of lung cancer can effectively accelerate the recovery of patients, alleviate their pain, shorten the length of hospital stay, reduce hospitalization expense and improve patient's satisfaction, so it is worth clinically applying.","[{'ForeName': 'Yongkai', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang 110042, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yegang', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1412,33099941,Efficacy of nedaplatin combined with docetaxel in patients with nasopharyngeal carcinoma and its influence on ECRG4 and VEGF expressions.,"PURPOSE


To explore the efficacy of nedaplatin combined with docetaxel in patients with nasopharyngeal carcinoma and its influence on the expressions of esophageal cancer-related gene 4 (ECRG4) and vascular endothelial growth factor (VEGF).
METHODS


86 patients with nasopharyngeal carcinoma, admitted to and treated in our hospital from March 2016 to February 2018, were selected and randomly divided into control group (n=43) and observation group (n=43). Chemotherapy combining cisplatin with fluorouracil was administered in the control group, while nedaplatin combined with docetaxel was given in the observation group. Then the efficacy, adverse reactions, the levels of serum hypoxia-inducible factor-1α (HIF-1α) and VEGF in patients before and after treatment, and the change in the expression level of ECRG4 in foci after treatment were compared between the two groups. After 1-year follow-up, the improvement in quality of life was compared between the two groups of patients.
RESULTS


The objective remission rate and disease control rate in the observation group were obviously higher than in the control group (p<0.05), and the total incidence rate of adverse reactions in the observation group was evidently lower than in the control group (p<0.05). At 2, 4, and 6 weeks after treatment, the two groups of patients had substantially decreased levels of serum HIF-1α and VEGF, and the declines were more apparent in the observation group (p<0.05). The expression level of ECRG4 in foci in the observation group was remarkably higher than in the control group (p<0.05). The observation group exhibited more apparent improvement in quality of life than the control group (p<0.05).
CONCLUSIONS


Nedaplatin combined with docetaxel has better short-term efficacy in nasopharyngeal carcinoma, with milder adverse reactions, and it can reduce the levels of serum HIF-1α and VEGF, and up-regulate ECRG4 expression in patients, exerting an anti-carcinoma effect.",2020,The expression level of ECRG4 in foci in the observation group was remarkably higher than in the control group (p<0.05).,"['86 patients with nasopharyngeal carcinoma, admitted to and treated in our hospital from March 2016 to February 2018', 'patients with nasopharyngeal carcinoma']","['Nedaplatin combined with docetaxel', 'nedaplatin combined with docetaxel', 'Chemotherapy combining cisplatin with fluorouracil']","['objective remission rate and disease control rate', 'expressions of esophageal cancer-related gene 4 (ECRG4) and vascular endothelial growth factor (VEGF', 'expression level of ECRG4', 'total incidence rate of adverse reactions', 'efficacy, adverse reactions, the levels of serum hypoxia-inducible factor-1α (HIF-1α) and VEGF', 'levels of serum HIF-1α and VEGF', 'quality of life', 'ECRG4 and VEGF expressions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0093999', 'cui_str': 'nedaplatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",86.0,0.0243049,The expression level of ECRG4 in foci in the observation group was remarkably higher than in the control group (p<0.05).,"[{'ForeName': 'Dongzhi', 'Initials': 'D', 'LastName': 'Zuo', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, affiliated Hospital of Guilin Medical University, Guilin, China.'}, {'ForeName': 'Guancheng', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Yanyong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1413,33100184,Response heterogeneity in a randomized controlled trial of telerehabilitation interventions among adults with multiple sclerosis.,"INTRODUCTION


Telerehabilitation may be effective on average but is not equally effective among all people with multiple sclerosis (MS). Thus, the purpose of this secondary analysis of a randomized controlled trial was to explore whether baseline characteristics of participants with MS influence fatigue and physical activity outcomes of three telerehabilitation interventions.
METHODS


Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). The 12-week interventions were delivered over the phone. Sociodemographic (age and income), clinical (comorbidities, mental function and physical function), psychosocial (self-efficacy, outcome expectations and goal-setting), and behavioural baseline characteristics (step count and fatigue self-management behaviors) were used in a moderated regression analysis and a responder analysis to examine their influence on the Fatigue Impact Scale (FIS) and Godin Leisure-Time Exercise Questionnaire (GLTEQ) at post-test (i.e. immediately post-interventions).
RESULTS


No interactions terms were statistically significant in the moderation analysis. However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different ( p  < 0.05) between responders and non-responders. Specifically, non-responders on the FIS at post-test in the PA-only intervention had significantly lower baseline scores in goal setting for engaging in fatigue self-management behaviours. Also, non-responders on the GLTEQ at post-test in the FM+ intervention had significantly worse baseline scores in mental function.
DISCUSSION


Further research is needed to understand the complex relationship among baseline characteristics, telerehabilitation and response heterogeneity. We discuss how research on examining response heterogeneity may be advanced by conducting mega-clinical trials, secondary analyses of big data, meta-analyses and employing non-traditional research designs.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT01572714).",2020,"However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different ( p  < 0.05) between responders and non-responders.","['people with multiple sclerosis (MS', 'Participants', 'participants with MS influence', 'adults with multiple sclerosis']","['contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM', 'telerehabilitation interventions']","['baseline psychosocial characteristics and mental function', 'Sociodemographic (age and income), clinical (comorbidities, mental function and physical function), psychosocial (self-efficacy, outcome expectations and goal-setting), and behavioural baseline characteristics (step count and fatigue self-management behaviors', 'fatigue and physical activity outcomes', 'Fatigue Impact Scale (FIS) and Godin Leisure-Time Exercise Questionnaire (GLTEQ']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0943401,"However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different ( p  < 0.05) between responders and non-responders.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Plow', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Canada.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Department of Physical Medicine & Rehabilitation, Neurological Institute, The Cleveland Clinic Foundation, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20964693']
1414,33100187,Effect of Group Cognitive Behavioural Therapy on Loneliness in a Community Sample of Older Adults: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVES


Research suggests a link between loneliness, depression, and anxiety. Multiple studies have examined treatment programs for loneliness; however, none have examined the efficacy of Cognitive Behavioral Therapy (CBT) for depression and anxiety in reducing loneliness.
METHODS


Change in loneliness in sixty-two older adults (≥60 yrs; 65% female) who took part in a previously reported randomized controlled trial for the treatment of comorbid depression and anxiety was examined. Older adults were randomized to a 12-week group CBT or waitlist control condition. Participants who took part in CBT were followed-up three months later.
RESULTS


Linear Mixed Model analyses indicated that after controlling for baseline cognition, depression, and anxiety, participants who completed CBT experienced a significant decrease in loneliness while the control group did not. This reduction was maintained at follow-up.
CONCLUSIONS


CBT programs for depression and anxiety are likely to be effective at reducing loneliness. This may be due to shared underlying cognitive and behavioral mechanisms between loneliness, depression, and anxiety such as sensitivity to perceived threat and social withdrawal. Further research is needed to understand if specific loneliness interventions are more effective.
CLINICAL IMPLICATIONS


CBT may be effective at reducing loneliness among older adults with depression and anxiety.",2020,"RESULTS


Linear Mixed Model analyses indicated that after controlling for baseline cognition, depression, and anxiety, participants who completed CBT experienced a significant decrease in loneliness while the control group did not.","['Change in loneliness in sixty-two older adults (≥60\xa0yrs; 65% female', 'Loneliness in a Community Sample of Older Adults', 'Older adults', 'older adults with depression and anxiety']","['Cognitive Behavioral Therapy (CBT', 'CBT or waitlist control condition', 'CBT programs', 'Group Cognitive Behavioural Therapy']","['loneliness', 'baseline cognition, depression, and anxiety']","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",62.0,0.0408848,"RESULTS


Linear Mixed Model analyses indicated that after controlling for baseline cognition, depression, and anxiety, participants who completed CBT experienced a significant decrease in loneliness while the control group did not.","[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University , Sydney, Australia.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Wuthrich', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University , Sydney, Australia.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Johnco', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University , Sydney, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Belcher', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University , Sydney, Australia.'}]",Clinical gerontologist,['10.1080/07317115.2020.1836105']
1415,33100212,Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind PlaceboControlled Clinical Trial.,"BACKGROUND


Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown anti-ulcerogenic and anti-inflammatory activity of this plant.
OBJECTIVES


We designed a clinical trial to evaluate efficacy of topical cream of M. sylvestris extract in management of children with AD.
METHODS


Fifty one children with AD were randomly enrolled in two arms of a randomized, double-blind, controlled clinical trial. They were treated by topical cream of M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure.
RESULTS


There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively).
CONCLUSION


According to the results of this clinical trial, it could be concluded that topical use of M. sylvestris extract cream was effective on the reduction of the AD symptoms in children.",2020,"There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively).
","['Pediatric Patients with Atopic Dermatitis', 'Fifty', 'children with AD', 'children', 'one children with AD']","['PlaceboControlled', 'Short Term Topical Malva Sylvestris L. Cream', 'topical cream of M. sylvestris extract or placebo', 'placebo', 'topical cream of M. sylvestris extract']","['SCORing Atopic Dermatitis (SCORAD) score', ""severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score""]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0330526', 'cui_str': 'Malva'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0241165', 'cui_str': 'Thick skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",51.0,0.541738,"There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively).
","[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Meysami', 'Affiliation': 'Department of Persian Medicine, The School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd. Iran.'}, {'ForeName': 'Mohammad Hashem', 'Initials': 'MH', 'LastName': 'Hashempur', 'Affiliation': 'Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa. Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran. Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Emtiazy', 'Affiliation': 'Research Center for Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Yazd. Iran.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530320666201023125411']
1416,33100327,Circulating biomarkers and outcomes from a randomised phase 2 trial of gemcitabine versus capecitabine-based chemoradiotherapy for pancreatic cancer.,"BACKGROUND


The Phase 2 SCALOP trial compared gemcitabine with capecitabine-based consolidation chemoradiotherapy (CRT) in locally advanced pancreatic cancer (LAPC).
METHODS


Thirty-five systematically identified circulating biomarkers were analysed in plasma samples from 60 patients enroled in SCALOP. Each was measured in triplicate at baseline (prior to three cycles of gemcitabine-capecitabine induction chemotherapy) and, for a subset, prior to CRT. Association with overall survival (OS) was determined using univariable Cox regression and optimal thresholds delineating low to high values identified using time-dependent ROC curves. Independence from known prognostic factors was assessed using Spearman correlation and the Wilcoxon rank sum test prior to multivariable Cox regression modelling including independent biomarkers and known prognostic factors.
RESULTS


Baseline circulating levels of C-C motif chemokine ligand 5 (CCL5) were significantly associated with OS, independent of other clinicopathological characteristics. Patients with low circulating CCL5 (CCL5 low ) had a median OS of 18.5 (95% CI 11.76-21.32) months compared to 11.3 (95% CI 9.86-15.51) months in CCL5 high ; hazard ratio 1.95 (95% CI 1.04-8.65; p = 0.037).
CONCLUSIONS


CCL5 is an independent prognostic biomarker in LAPC. Given the known role of CCL5 in tumour invasion, metastasis and the induction of an immunosuppressive micro-environment, targeting of CCL5-mediated pathways may offer therapeutic potential in pancreatic cancer.
CLINICAL TRIAL REGISTRATION


The SCALOP trial was registered with ISRCTN, number 96169987 (registered 29 May 2008).",2020,"RESULTS


Baseline circulating levels of C-C motif chemokine ligand 5 (CCL5) were significantly associated with OS, independent of other clinicopathological characteristics.","['Thirty-five systematically identified circulating biomarkers were analysed in plasma samples from 60 patients enroled in SCALOP', 'locally advanced pancreatic cancer (LAPC', 'pancreatic cancer']","['gemcitabine with capecitabine-based consolidation chemoradiotherapy (CRT', 'gemcitabine-capecitabine induction chemotherapy', 'gemcitabine versus capecitabine-based chemoradiotherapy']","['median OS', 'overall survival (OS']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.123276,"RESULTS


Baseline circulating levels of C-C motif chemokine ligand 5 (CCL5) were significantly associated with OS, independent of other clinicopathological characteristics.","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Willenbrock', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catrin M', 'Initials': 'CM', 'LastName': 'Cox', 'Affiliation': 'Centre for Trials Research, Cardiff, UK.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Parkes', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Wilhelm-Benartzi', 'Affiliation': 'Centre for Trials Research, Cardiff, UK.'}, {'ForeName': 'Aswin G', 'Initials': 'AG', 'LastName': 'Abraham', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Owens', 'Affiliation': 'Oxford University Hospital NHS Trust, Oxford, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sabbagh', 'Affiliation': 'Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Jones', 'Affiliation': 'University of Leeds & Leeds Cancer Centre, Leeds, UK.'}, {'ForeName': 'Daniel L I', 'Initials': 'DLI', 'LastName': 'Hughes', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Maughan', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Hurt', 'Affiliation': 'Centre for Trials Research, Cardiff, UK.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK. somnath.mukherjee@oncology.ox.ac.uk.'}]",British journal of cancer,['10.1038/s41416-020-01120-z']
1417,33100376,Benefits of Playing Numerical Card Games on Head Start Children's Mathematical Skills.,"Low-income preschoolers have lower average performance on measures of early numerical skills than middle-income children. The present study examined the effectiveness of numerical card games in improving children's numerical and executive functioning skills. Low-income preschoolers (N=76) were randomly assigned to play a numerical magnitude comparison card game, a numerical memory and matching card game, or a shape and color matching card game across four 15-minute sessions. Child who played either of the numerical games improved their numeral identification skills, while only children who played the numerical magnitude comparison game improved their symbolic magnitude comparison skills. These improvements were maintained eight weeks later. The results suggest that a brief, low-cost intervention can successfully improve the numerical skills of low-income children.",2020,"Child who played either of the numerical games improved their numeral identification skills, while only children who played the numerical magnitude comparison game improved their symbolic magnitude comparison skills.","['Low-income preschoolers (N=76', ""Head Start Children's Mathematical Skills""]","['numerical card games', 'Playing Numerical Card Games']","[""children's numerical and executive functioning skills"", 'numeral identification skills', 'symbolic magnitude comparison skills']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1720186', 'cui_str': 'Numeral'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",76.0,0.020715,"Child who played either of the numerical games improved their numeral identification skills, while only children who played the numerical magnitude comparison game improved their symbolic magnitude comparison skills.","[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Scalise', 'Affiliation': 'University of Maryland, College Park.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Daubert', 'Affiliation': 'Rutgers University, Newark.'}, {'ForeName': 'Geetha B', 'Initials': 'GB', 'LastName': 'Ramani', 'Affiliation': 'University of Maryland, College Park.'}]",Journal of experimental education,['10.1080/00220973.2019.1581721']
1418,33100426,Testing the Effectiveness of Cognitive Behavioral Therapy in Relieving Nurses' Ageism Toward Older Adults: A Randomized Controlled Trial.,"Background


Although cognitive-behavioral therapy (CBT) techniques are well known for targeting psychological distresses, to date, no study has investigated their effectiveness in relieving death anxiety and ageism among nurses.
Methods


A parallel randomized controlled trial was conducted according to the CONSORT guidelines during October 2019 at the university hospital. A total of 110 nurses were selected through proportional stratified sampling and randomly assigned to the experimental and control groups. The intervention consisted of six two-hour training sessions delivered over five modules with the integration of different CBT exercises. The effect of CBT was assessed by measuring the differences in the students' responses to a series of validated questionnaires of study variables pre-test (before the training sessions) and post-test (after the training sessions). Clinical registration was completed at ClinicalTrial.gov (ID: NCT04319393).
Results


Overall, using CBT techniques led to significant improvements in the study outcomes. At postintervention, the nurses who had received CBT training had significantly better self-esteem and interpersonal relationships, a greater sense of symbolic immortality, and less death anxiety and ageism than the nurses in the control group.
Conclusions


CBT is an effective evidence-based psychological intervention for relieving nurses' ageism towards older adults. The psychological well-being of nurses caring for older adults is crucial, and new techniques should be adopted to relieve nurses' accumulated stress and decrease their death anxiety. Future studies which investigate the effectiveness of CBT on other forms of discrimination, such as racism and sexism in healthcare settings, are recommended.",2020,"At postintervention, the nurses who had received CBT training had significantly better self-esteem and interpersonal relationships, a greater sense of symbolic immortality, and less death anxiety and ageism than the nurses in the control group.
","['CONSORT guidelines during October 2019 at the university hospital', 'older adults', 'Older Adults', 'A total of 110 nurses']","['CBT', 'cognitive-behavioral therapy (CBT) techniques', 'CBT training', 'CBT exercises', 'Cognitive Behavioral Therapy']","['self-esteem and interpersonal relationships, a greater sense of symbolic immortality, and less death anxiety and ageism']","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}, {'cui': 'C0242449', 'cui_str': 'Age Discrimination'}]",110.0,0.0567721,"At postintervention, the nurses who had received CBT training had significantly better self-esteem and interpersonal relationships, a greater sense of symbolic immortality, and less death anxiety and ageism than the nurses in the control group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rababa', 'Affiliation': 'Department of Adult Health Nursing, Faculty of Nursing, Jordan University of Science and Technology/School of Nursing, P O Box 3030, Irbid, 22110 Jordan.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Alhawatmeh', 'Affiliation': 'Department of Adult Health Nursing, Faculty of Nursing, Jordan University of Science and Technology/School of Nursing, P O Box 3030, Irbid, 22110 Jordan.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Al Ali', 'Affiliation': 'Department of Community and Psychiatric Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Kassab', 'Affiliation': 'Department of Maternal and Child Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}]",Cognitive therapy and research,['10.1007/s10608-020-10167-4']
1419,33100632,International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial and the appropriateness of revascularization.,"The recently published ISCHEMIA trial which is a prospective randomized multi-centre trial has concluded that there was no evidence that an initial invasive strategy of revascularisation in patients with stable angina reduced the risk of ischaemic cardiovascular events or death from any cause. The trial has confirmed that patients with stable angina do not greatly benefit from revascularisation and optimal medical treatment (OMT) is an acceptable alternative. The trial has also confirmed that in patients with stable angina and end-stage renal impairment, OMT is once again an equally effective initial strategy. While the ISCHEMIA trial is one of the most rigorously and meticulously conducted trial, exclusion of symptomatic patients, recruitment of patients who are not known to derive significant benefit from revascularisation and those who were at low risk of clinical events, along with a short follow-up period, may all have contributed to the lack of difference seen between the groups. The fact that the ISCHEMIA trial does not represent the entire cohort of real-life patients requiring revascularisation should be borne in mind, and care should be taken in extrapolating these results to the wider group of patients requiring revascularisation for coronary artery disease.",2020,The trial has confirmed that patients with stable angina do not greatly benefit from revascularisation and optimal medical treatment (OMT) is an acceptable alternative.,"['patients with stable angina and end-stage renal impairment', 'patients with stable angina']",['Medical and Invasive Approaches (ISCHEMIA'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",[],,0.0819475,The trial has confirmed that patients with stable angina do not greatly benefit from revascularisation and optimal medical treatment (OMT) is an acceptable alternative.,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences, 124, EM Bypass, Mukundapur, Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-020-00961-w']
1420,33100752,Objective assessment of mouth opening after buccal mucosal graft urethroplasty: A prospective study.,"Introduction and Objectives


Buccal mucosal graft (BMG) is frequently used for the reconstruction of urethral strictures with acceptable donor-site morbidity after graft harvest. There are only a few prospectively designed studies with a small number of patients reporting oral complications, particularly the mouth opening in the long terms. We did an objective assessment of mouth opening before and after 6 months of BMG urethroplasty as well as pain scores.
Materials and Methods


Fifty-eight patients who underwent BMG urethroplasty were included in the study between May 2013 and December 2014. Preoperative mouth opening (reference point between two incisors with the highest of three readings taken as final) was measured using a Vernier caliper. Harvest site was left open to heal by secondary intentions. Postoperatively, mouth opening and pain scores using self-administered (Visual Analog Scale [VAS]) assessed on day 1 and day 3, and follow-up at 1 week, 1 month, and 6 months. Data were analyzed as mean (standard deviation [SD]), proportion, and median (inter-quartile range [IQR]) with two-tailedP < 0.05 as statistically significant.
Results


The mean age was 39.6 years. The graft was harvested from a single cheek in 50% of patients. In remaining, it was taken from both cheeks, both cheeks with lip, and both cheeks with the tongue in 29.31%, 17.24%, and 3.5%, of patients, respectively. Preoperative mouth opening (5.13 cm [0.08]) was statistically significantly more than mouth opening on day 1 (4.34 cm [0.09]), day 3 (4.48 [0.09]), and day 7 (4.69 cm [0.09]). Mean difference became insignificant at the interval of 1 month (4.91 cm [0.09]) with 6 months' values showing marginal improvement over preoperative values (5.14 cm [0.07]). Pain was tolerable and patients reported low median VAS 2 (2-4) on day 1 and day 3 each. Reported median VAS became 0 (0-0) on day 7.
Conclusion


Mouth opening restriction after BMG urethroplasty is a definite entity in the initial postoperative period, which becomes nonsignificant by 6 months. The pain has no effect on mouth opening.",2020,"Preoperative mouth opening (5.13 cm [0.08]) was statistically significantly more than mouth opening on day 1 (4.34 cm [0.09]), day 3 (4.48 [0.09]), and day 7 (4.69 cm [0.09]).",['Materials and Methods\n\n\nFifty-eight patients who underwent BMG urethroplasty were included in the study between May 2013 and December 2014'],['mouth opening after buccal mucosal graft urethroplasty'],"['Preoperative mouth opening', 'pain scores', 'Postoperatively, mouth opening and pain scores using self-administered (Visual Analog Scale [VAS', 'Pain']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",58.0,0.104523,"Preoperative mouth opening (5.13 cm [0.08]) was statistically significantly more than mouth opening on day 1 (4.34 cm [0.09]), day 3 (4.48 [0.09]), and day 7 (4.69 cm [0.09]).","[{'ForeName': 'Kaushal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Urology and Kidney Transplantation, Sri Sathya Sai Institute of Higher Medical Sciences, Anantapur, Andhra Pradesh, India.'}, {'ForeName': 'Jaisukh', 'Initials': 'J', 'LastName': 'Kalathia', 'Affiliation': 'Department of Urology and Kidney Transplantation, Sri Aurobindo Institute of Medical Sciences, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Urology and Kidney Transplantation, Sri Sathya Sai Institute of Higher Medical Sciences, Anantapur, Andhra Pradesh, India.'}]",Urology annals,['10.4103/UA.UA_84_19']
1421,33100782,Impact assessment of pharmacist-supervised intervention on health-related quality of life of newly diagnosed diabetics: A pre-post design.,"Introduction


Diabetics face a series of challenges that affect all aspects of their daily life. Diabetes related complications adversely affect patient's health-related quality of life (HRQoL). Knowledge and self-care skills of diabetics are corner stones to improve their HRQoL.
Objective


To assess the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics using an Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire.
Materials and Methods


A pre-post comparison study was conducted among the control group (CG), test 1 group (T1G) and test 2 group (T2G) patients with three treatment arms to explore the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics for 18 months. Patients' HRQoL scores were determined using ADDQoL questionnaire at baseline, 3, 6, 9 and 12-months. T1G patients received pharmacist's intervention whereas T2G patients received diabetic kit demonstration in addition to pharmacist's intervention. CG patients were deprived of pharmacist intervention and diabetic kit demonstration, and only received care from attending physician/nurses. Non-parametric tests were used to find the differences in an average weighted impact scores (AWIS) among the groups before and after the intervention at  P  ≤ 0.05.
Results


Friedman test identified significant ( P  < 0.001) improvement in AWIS among the test groups' patients. Differences in scores were significant between T1G and T2G at 6-months ( P  = 0.033), 9-months ( P  < 0.001) and 12-months ( P  < 0.001); between CG and T1G at 12-months ( P  < 0.001) and between CG and T2G at 9-months ( P  < 0.001) and 12-months ( P  < 0.0010) on Mann.Whitney U test.
Conclusion


Pharmacist's intervention improved AWIS of test groups' diabetics. Diabetic kit demonstration strengthened the disease understanding and selfcare skills of T2G patients. Disease and self-care awareness among diabetics should be increased in Nepali healthcare system by involving pharmacists for better patient's related outcomes.",2020,Differences in scores were significant between T1G and T2G at 6-months,"['newly diagnosed diabetics', 'T2G patients']","['pharmacist-supervised intervention', ""pharmacist's intervention"", ""diabetic kit demonstration in addition to pharmacist's intervention""]","['HRQoL scores', 'health-related quality of life', 'quality of life (HRQoL', ""AWIS of test groups' diabetics""]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",,0.025684,Differences in scores were significant between T1G and T2G at 6-months,"[{'ForeName': 'Dinesh K', 'Initials': 'DK', 'LastName': 'Upadhyay', 'Affiliation': 'Faculty of Pharmacy, AIMST University, Semeling, Jalan Bedong, Kedah Darul Aman, Bedong, Kedah, Malaysia.'}, {'ForeName': 'Mohamed Izham', 'Initials': 'MI', 'LastName': 'Mohamed Ibrahim', 'Affiliation': 'Department of Social and Administrative Pharmacy, College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Pranaya', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Associate Dean of Student affairs & Academic Chief of Staff, ROSS University School of Medicine, FL, USA.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Alurkar', 'Affiliation': 'Department of Medicine, Manipal College of Medical Sciences and Manipal Teaching Hospital, Pokhara, Nepal.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_6_20']
1422,33100817,Single-Port vs. Conventional Multi-Port Laparoscopic Lymph Node Biopsy.,"Background and Objectives


The purpose of the investigation was to compare clinical results and diagnostic accuracy for conventional multiport laparoscopic lymph node biopsy (MPLB) and single-port laparoscopic lymph node biopsy (SPLB) operations at a single institution.
Methods


A set of 20 SPLB patients operated on from October 2016 to May 2019 were compared to an historical series of 35 MPLB patients. Primary endpoints were the time of surgery, estimated blood loss, surgical conversion, length of stay and morbidity. The secondary endpoint was the diagnostic accuracy of the technique.
Results


SPLB was completed laparoscopically in all cases. Two MPLB patients (5.7%) experienced a surgical conversion due to intraoperative difficulties. Duration of surgery was similar in SPLB and MPLB groups respectively (84 ± 31.7 min vs. 81.1 ± 22.2;  P  = .455). A shorter duration of hospital stay was shown for patients operated on by SPLB compared to the MPLB group (1.7 ± 0.9 days vs. 2.1 ± 1.2 days;  P  =   .133). The postoperative course was uneventful in both groups. In 95% of the SPLB and 97.1% of the MPLB cases respectively, LLB achieved the necessary information for the diagnosis.
Conclusion


SPLB has shown good procedural and postoperative outcomes as well as a high diagnostic yield, comparable to traditional MPLB. Therefore, our results show that this approach is safe and effective and can be an equally valid option to MPLB to obtain a diagnosis or to follow the progression of a lymphoproliferative disease. Further studies are necessary to support these results before its widespread adoption.",2020,A shorter duration of hospital stay was shown for patients operated on by SPLB compared to the MPLB group (1.7 ± 0.9 days vs. 2.1 ± 1.2 days;  P  =   .133).,['20 SPLB patients operated on from October 2016 to May 2019 were compared to an historical series of 35 MPLB patients'],"['MPLB', 'conventional multiport laparoscopic lymph node biopsy (MPLB) and single-port laparoscopic lymph node biopsy (SPLB) operations', 'Single-Port vs. Conventional Multi-Port Laparoscopic Lymph Node Biopsy']","['Duration of surgery', 'diagnostic accuracy of the technique', 'duration of hospital stay', 'surgical conversion', 'time of surgery, estimated blood loss, surgical conversion, length of stay and morbidity', 'postoperative course']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193842', 'cui_str': 'Biopsy of lymph node'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205549', 'cui_str': 'Series'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193842', 'cui_str': 'Biopsy of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",,0.0321694,A shorter duration of hospital stay was shown for patients operated on by SPLB compared to the MPLB group (1.7 ± 0.9 days vs. 2.1 ± 1.2 days;  P  =   .133).,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Casaccia', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Fornaro', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Papadia', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Testa', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mascherini', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}, {'ForeName': 'Adalberto', 'Initials': 'A', 'LastName': 'Ibatici', 'Affiliation': 'Hematology and Transplant Center Division, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ghiggi', 'Affiliation': 'Hematology and Transplant Center Division, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Bregante', 'Affiliation': 'Hematology and Transplant Center Division, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'De Cian', 'Affiliation': 'Surgical Clinic Unit I, Department of Surgical Sciences and Integrated Diagnostics, Genoa University, Genoa, Italy.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00045']
1423,33100818,Electrostatic Precipitation in Low Pressure Laparoscopic Hysterectomy and Myomectomy.,"Background and Objective


The purpose of this study was to evaluate the impact of using electrostatic precipitation to manage the surgical plume during low pressure laparoscopic gynecologic procedures.
Methods


This was a prospective, blinded, randomized controlled study of women with a clinical indication for laparoscopic hysterectomy (n = 30) or myomectomy (n = 5). Patients were randomized to either use electrostatic precipitation (EP) during the procedure, or not (No EP, hysterectomy group only).
Results


Low pressure surgery could be undertaken in 87% of hysterectomy cases (13/15) when using EP to manage the surgical plume, compared to only 53% (8/15) in the No EP group. Overall average rating of the visual field was excellent with EP vs fair for No EP. Average CO 2  consumption was reduced by 29% when using EP (16.7L vs 23.5L,  p  = 0.152). The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case,  p  = 0.005). Average procedure duration for the EP vs No EP group was 40.5 min vs. 46.9 min ( p  =   0.987). There were no measurable differences between groups for body temperature, end-tidal CO 2 , and discharge pain scores. In myomectomy, all five cases could be performed at low pressure, with an excellent visual field rating.
Conclusion


Electrostatic precipitation enhances low pressure laparoscopic hysterectomy and myomectomy. This was achieved by minimizing interruptions to surgery and exchange of CO 2 ; providing a clear visual field throughout the procedure; and eliminating surgical smoke at the site of origin.",2020,"The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case,  p  = 0.005).","['Low Pressure Laparoscopic Hysterectomy and Myomectomy', 'women with a clinical indication for laparoscopic hysterectomy (n\u2009=\u200930) or myomectomy (n\u2009=\u20095']","['Electrostatic precipitation', 'Electrostatic Precipitation', 'electrostatic precipitation (EP) during the procedure, or not (No EP, hysterectomy group only', 'electrostatic precipitation']","['average number of procedural pauses to vent smoke', 'Average CO 2  consumption', 'Average procedure duration', 'Overall average rating of the visual field', 'body temperature, end-tidal CO 2 , and discharge pain scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0376534', 'cui_str': 'Electrostatics'}, {'cui': 'C0032932', 'cui_str': 'Precipitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0901288,"The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case,  p  = 0.005).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levine', 'Affiliation': 'Department of Obstetrics and Gynecology, Mercy Hospital, 621 S. New Ballas Rd, St. Louis, Missouri.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Petroski', 'Affiliation': 'Biostatistics & Research Design Unit, University of Missouri - Columbia School of Medicine, 182C Galena Hall, Columbia, Missouri.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Haertling', 'Affiliation': 'Mercy Research, 3231 S. National Ave., Ste 210, Springfield, Missouri.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Beaudoin', 'Affiliation': 'Mercy Research, 615 S. New Ballas Rd, Ste 2010, St. Louis, Missouri.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00051']
1424,33100841,Evaluating the effect of health education program on outcomes of type I diabetic patients: A randomized controlled study.,"Background; findings from the meta-analysis have shown that patients present improvements in glycaemic control, and in the prevention and control of the acute and chronic complications, when they receive effective treatment, self-management support and regular monitoring. The present study aimed to evaluate the effect of implementing a health education program on outcomes of type I diabetic patients. Quasi-experimental study design was used to fulfill the aim of the study. The study was conducted in the outpatient diabetic clinic at Asyut University Hospital; 60 adult male and female patients who attended the outpatient diabetic clinic were included. Two tools were used in this study; structured interviewing questionnaire with three parts; part one: demographic patient variables, part two: patient's medical data and part three: patient's knowledge regarding diabetes, the second tool is evaluation of type I diabetic patients' outcomes (pre/post). Results revealed that the highest percentage of the studied samples were in the age group 18 to less than 30 years, 90.0% of the study group and 83.4% of the control group were having a family history of diabetes, a statistically significant difference was found in the study group patients pre and post application of the program regarding insulin injection and glycemic control. Conclusion: this study demonstrated the effectiveness of health education program implementation on the outcomes of type I diabetic patients in terms of improved knowledge and practicing exercise, teeth care, feet care and on glycemic control.",2020,this study demonstrated the effectiveness of health education program implementation on the outcomes of type,"['I diabetic patients', 'outpatient diabetic clinic at Asyut University Hospital; 60 adult male and female patients who attended the outpatient diabetic clinic were included', 'type I diabetic patients']","['health education program implementation', ""structured interviewing questionnaire with three parts; part one: demographic patient variables, part two: patient's medical data and part three: patient's knowledge regarding diabetes, the second tool is evaluation of type"", 'health education program']","['knowledge and practicing exercise, teeth care, feet care and on glycemic control']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0195753,this study demonstrated the effectiveness of health education program implementation on the outcomes of type,"[{'ForeName': 'Sahar A', 'Initials': 'SA', 'LastName': 'Abd-El Mohsen', 'Affiliation': 'Department of Nursing Sciences, College of Applied Medical Sciences in Wadi Alddawasir, Prince Sattam bin Abdulaziz University, Postal code: 18616, Saudi Arabia.'}, {'ForeName': 'Azhar A', 'Initials': 'AA', 'LastName': 'Mohamed Shehata', 'Affiliation': 'Department of Nursing Sciences, College of Applied Medical Sciences in Wadi Alddawasir, Prince Sattam bin Abdulaziz University, Postal code: 18616, Saudi Arabia.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.09.018']
1425,33100854,"Acute effects of  Amomum villosum  Lour. fruit extract on postprandial glycemia and insulin secretion: A single-blind, placebo-controlled, crossover study in healthy subjects.","Background


Amomum villosum  Lour., (Zingiberaceae) an herbaceous plant in the ginger family, has been used to treat various diseases. In a single-blind, randomized, crossover study, we assessed the postprandial blood insulin and blood glucose responses in healthy subjects (n = 40) after the  Amomum villosum  water extract (AVE) (5 g/person) or a placebo (5 g/person) consumption.
Methods


During each treatment course, the healthy subject consumed a regular late afternoon meal, followed by fasting for 12 h, and arrived at the clinical study center the next morning. Blood insulin and blood glucose levels were assessed at 0, 30, 60, 90, and 120 min after AVE consumption. Between each treatment, the subjects accomplished one week of a washout period.
Results


The AVE intake demonstrated a significant (67.26%) decline in postprandial blood glucose AUC 0-120 min  (incremental area under the curve from 0 to 120 min) versus the placebo ( P  = 0.011). Furthermore, AVE reduced postprandial blood insulin AUC 0-120 min  by 59.95% compared to the placebo group ( P  < 0.003), supporting the blood glucose results.
Conclusion


This study revealed that AVE consumption significantly reduced postprandial insulin and glucose levels in healthy individuals, due in part to inhibition of α-glucosidase, and glucose transport.",2020,The AVE intake demonstrated a significant (67.26%) decline in postprandial blood glucose AUC 0-120 min  (incremental area under the curve from 0 to 120 min) versus the placebo ( P  = 0.011).,"['healthy individuals', 'healthy subjects (n\xa0=\xa040) after the  Amomum villosum  water extract', 'healthy subjects']","['placebo (5\xa0g/person) consumption.\nMethods', 'placebo', 'fruit extract']","['postprandial glycemia and insulin secretion', 'postprandial blood glucose AUC 0-120 min  (incremental area under the curve', 'postprandial insulin and glucose levels', 'postprandial blood insulin AUC', 'postprandial blood insulin and blood glucose responses', 'AVE', 'Blood insulin and blood glucose levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1136081', 'cui_str': 'Amomum'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.0486634,The AVE intake demonstrated a significant (67.26%) decline in postprandial blood glucose AUC 0-120 min  (incremental area under the curve from 0 to 120 min) versus the placebo ( P  = 0.011).,"[{'ForeName': 'Ha-Rim', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Ilwonbio Co., Ltd., & Department of Physiology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Antonisamy', 'Initials': 'A', 'LastName': 'Paulrayer', 'Affiliation': 'Ilwonbio Co., Ltd., & Department of Physiology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Yong-Gwan', 'Initials': 'YG', 'LastName': 'Kwon', 'Affiliation': 'Ilwonbio Co., Ltd., & Department of Physiology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Do-Gon', 'Initials': 'DG', 'LastName': 'Ryu', 'Affiliation': 'Ilwonbio Co., Ltd., & Department of Physiology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Dong-Gi', 'Initials': 'DG', 'LastName': 'Baek', 'Affiliation': 'Iksan Korean Medicine Hospital, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Geum', 'Affiliation': 'Iksan Korean Medicine Hospital, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Jung-Han', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Iksan Korean Medicine Hospital, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Geum-San', 'Initials': 'GS', 'LastName': 'Lee', 'Affiliation': 'Department of Herbology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}, {'ForeName': 'Kang-Beom', 'Initials': 'KB', 'LastName': 'Kwon', 'Affiliation': 'Ilwonbio Co., Ltd., & Department of Physiology, Wonkwang University School of Korean Medicine, Iksan, Jeonbuk, South Korea.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.07.017']
1426,33100913,"Efficacy and safety of propolis mouthwash in management of radiotherapy induced oral mucositis; A randomized, double blind clinical trial.","Aim and Background


Propolis has been used for the management of oral mucositis in a number of studies. Due to lack of sufficient evidence especially in radiotherapy induced oral mucositis, the present study was designed to evaluate the efficacy and safety of propolis mouthwash in oral mucositis and dysphagia in patients undergoing head and neck radiotherapy.
Materials and methods


This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients randomly divided into two groups receiving either the propolis or the placebo mouthwash. Patients were advised to rinse their mouth with 15 mL three times daily for four weeks. Severity of mucositis and dysphagia were evaluated by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and Common Terminology Criteria for Adverse Events (CTCAE), respectively.
Results


Thirty patients completed the study. Each group consisted of 15 patients. Although, there is not any significant difference between two groups in the first week of radiotherapy, a significant difference was seen in the second, the third and the fourth week (p = 0.03, 0.02, 0.02, respectively). Dysphagia reported as a mild score in the propolis group only in the fourth week which is significant compared with the placebo group (p = 0.01). There is not any serious adverse effect related to propolis or placebo during the study.
Conclusion


It seems that propolis mouthwash is an effective and safe medication for alleviation of oral mucositis and dysphagia in patients under head and neck radiotherapy.",2020,Dysphagia reported as a mild score in the propolis group only in the fourth week which is significant compared with the placebo group (p = 0.01).,"['Thirty patients completed the study', 'patients under head and neck radiotherapy', 'patients undergoing head and neck radiotherapy']","['placebo mouthwash', 'placebo', 'propolis mouthwash', 'radiotherapy']","['Severity of mucositis and dysphagia', 'efficacy and safety', 'Efficacy and safety', 'Dysphagia', 'oral mucositis']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",30.0,0.265157,Dysphagia reported as a mild score in the propolis group only in the fourth week which is significant compared with the placebo group (p = 0.01).,"[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ameri', 'Affiliation': 'Department of Radiotherapy, Imam Hossein Hospital, Shahid Beheshti University of Medical Scinces, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Dodge', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamidi Shishvan', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Pirsalehi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinazari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology,['10.1016/j.rpor.2020.09.012']
1427,33100948,"Prevention and treatment of cystitis during menopause: efficacy of a nutraceutical containing D-mannose, inulin, cranberry, bearberry,  Olea europaea, Orthosiphon  and  Lactobacillus acidophilus .","Aim of the study


To evaluate the efficacy of a nutraceutical compound containing Uticlin® (D-mannose, cranberry, bearberry,  Olea europaea ), inulin,  Orthosiphon  and  Lactobacillus acidophilus , in preventing recurrent urinary tract infections (UTIs) in menopausal women.
Material and methods


This was a prospective cohort study of menopausal women recruited with a history of recurrent UTIs in the previous twelve months and who intended to treat their bladder problem without the use of antibiotics and/or anti-inflammatories. Women were proposed the use of an oral nutraceutical compound. The drug was taken for ten days, every month. Women were assigned to two parallel cohorts: patients using (group 1) or not using (group 2) this nutraceutical compound. The primary objective of the study was to evaluate the number of women with less than two infective episodes in the 6-month follow-up and less than three episodes in the 12-month follow-up. The secondary endpoints were to evaluate the reduction of related symptoms at 12-month follow-up, according to the Visual Analog Scale (VAS).
Results


At 6 months of therapy, the reduction in the number of patients with ≥ 2 UTIs was statistically significant ( p  < 0.05) compared to baseline only in group 1. At 12 months, the number of patients who were disease-free was significantly higher ( p  < 0.05) in group 1 compared to group 2. Moreover, the improvement of related symptoms was statistically significant ( p  < 0.05) in group 1, as shown by the reduction in the VAS scale value.
Conclusions


In menopausal women, the combination of D-mannose, inulin, cranberry, bearberry,  Olea europaea, Orthosiphon  and  Lactobacillus acidophilus  SGL 11 per os represents a useful therapy for recurrent UTIs in women wanting a natural approach.",2020,"At 12 months, the number of patients who were disease-free was significantly higher ( p  < 0.05) in group 1 compared to group 2.","['cystitis during menopause', 'menopausal women recruited with a history of recurrent UTIs in the previous twelve months and who intended to treat their bladder problem without the use of antibiotics and/or anti-inflammatories', 'menopausal women']","['nutraceutical compound containing Uticlin® (D-mannose, cranberry, bearberry,  Olea europaea ), inulin,  Orthosiphon  and  Lactobacillus acidophilus', 'nutraceutical containing D-mannose, inulin, cranberry, bearberry,  Olea europaea, Orthosiphon  and  Lactobacillus acidophilus ']","['related symptoms', 'Visual Analog Scale (VAS', 'VAS scale value', 'disease-free']","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0579152', 'cui_str': 'Bladder problem'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0770993', 'cui_str': 'Bearberry'}, {'cui': 'C1122969', 'cui_str': 'Common Olive Tree'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1135837', 'cui_str': 'Orthosiphon'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0392635,"At 12 months, the number of patients who were disease-free was significantly higher ( p  < 0.05) in group 1 compared to group 2.","[{'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Mainini', 'Affiliation': 'Menopausal Center, San Leonardo Hospital, ASL NA3 SUD, Castellammare di Stabia, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Passaro', 'Affiliation': 'ASL NA3 SUD, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Schiattarella', 'Affiliation': 'Unit of Gynecology and Obstetrics, Department of Woman, Child and General and Specialized Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Pasquale De', 'Initials': 'P', 'LastName': 'Franciscis', 'Affiliation': 'Unit of Gynecology and Obstetrics, Department of Woman, Child and General and Specialized Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Mariano C Di', 'Initials': 'MCD', 'LastName': 'Donna', 'Affiliation': 'Department of Gynecologic Oncology, Arnas Civico, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Trezza', 'Affiliation': 'Unit of Gynecology and Obstetrics, Rummo Hospital, Benevento, Italy.'}]",Przeglad menopauzalny = Menopause review,['10.5114/pm.2020.99567']
1428,33100965,A Ketone Ester Drink Enhances Endurance Exercise Performance in Parkinson's Disease.,"Objectives


Routine exercise is thought to be among the only disease-modifying treatments for Parkinson's disease; however, patients' progressive loss of physical ability limits its application. Therefore, we sought to investigate whether a ketone ester drink, which has previously been shown to enhance endurance exercise performance in elite athletes, could also improve performance in persons with Parkinson's disease.
Participants


14 patients, aged 40-80 years, with Hoehn and Yahr stage 1-2 Parkinson's disease.
Intervention


A randomized, placebo-controlled, crossover study in which each participant was administered a ketone ester drink or an isocaloric carbohydrate-based control drink on separate occasions prior to engaging in a steady state cycling test at 80 rpm to assess endurance exercise performance.
Outcomes Measures


The primary outcome variable was length of time participants could sustain a therapeutic 80 rpm cadence. Secondary, metabolic outcomes measures included cardiorespiratory parameters as well as serum β-hydroxybutyrate, glucose, and lactate.
Results


The ketone ester increased the time that participants were able to sustain an 80 rpm cycling cadence by 24 ± 9% ( p  = 0.027). Correspondingly, the ketone ester increased β-hydroxybutyrate levels to >3 mmol/L and decreased respiratory exchange ratio, consistent with a shift away from carbohydrate-dependent metabolism.
Conclusion


Ketone ester supplementation improved endurance exercise performance in persons with Parkinson's disease and may, therefore, be useful as an adjunctive therapy to enhance the effectiveness of exercise treatment for Parkinson's disease.",2020,The ketone ester increased the time that participants were able to sustain an 80 rpm cycling cadence by 24 ± 9% ( p  = 0.027).,"[""Parkinson's Disease"", 'elite athletes', ""Participants\n\n\n14 patients, aged 40-80 years, with Hoehn and Yahr stage 1-2 Parkinson's disease"", ""persons with Parkinson's disease""]","['ketone ester drink or an isocaloric carbohydrate-based control drink', 'ketone ester drink', 'Ketone ester supplementation', 'Ketone Ester Drink', 'placebo']","['Endurance Exercise Performance', 'endurance exercise performance', 'β-hydroxybutyrate levels', 'length of time participants could sustain a therapeutic 80 rpm cadence', 'ketone ester', 'respiratory exchange ratio', 'cardiorespiratory parameters as well as serum β-hydroxybutyrate, glucose, and lactate']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0475506', 'cui_str': 'Ravens colored progressive matrices'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0436229,The ketone ester increased the time that participants were able to sustain an 80 rpm cycling cadence by 24 ± 9% ( p  = 0.027).,"[{'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Norwitz', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dearlove', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Sport and Health Sciences, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Department of Sport and Health Sciences, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'Michele T', 'Initials': 'MT', 'LastName': 'Hu', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Nuffield Department of Clinical Neurosciences, Oxford, United Kingdom.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.584130']
1429,33100983,"Effects of Nicotine Gum Administration on Vision (ENIGMA-Vis): Study Protocol of a Double-Blind, Randomized, and Controlled Clinical Trial.","Studies reported that tobacco addiction was related to visual impairments, but one unresolved issue is whether the impairments are related to the many compounds existing in the cigarettes or to the effects of nicotine. On the other hand, nicotine gum can be used as replacement therapy or as a neuroprotective agent for some diseases. The main purpose of this controlled trial is to investigate the effects of nicotine gum on vision. The ENIGMA-Vis trial aims to compare two dosages of nicotine gum (2 and 4 mg) and a placebo gum in a randomized, double-blind, placebo-controlled trial of 100 participants to be allocated into a single group assignment of repeated measures (two studies;  N  = 50 for each one). Eligibility criteria are healthy non-smokers not diagnosed with substance abuse and without an acute or chronic medical condition. Intervention will last three sessions for each participant with a window frame of 1 week per session. Study outcomes are (1) short-term effects of nicotine gum on contrast sensitivity; (2) short-term effects of nicotine gum on chromatic contrast discrimination; and (3) whether demographics, body mass index, or serum cotinine predicts response of visual processing. This study addresses an important gap in the effects of nicotine on vision. One of the main takeaways of this study is to understand the effects of nicotine on contrast sensitivity and chromatic contrast discrimination. This information will provide a further understanding of how nicotine interacts with early visual processes and help determine how the different components present during smoking can affect vision.  Clinical Trial Registration Number:  RBR-46tjy3.",2020,One of the main takeaways of this study is to understand the effects of nicotine on contrast sensitivity and chromatic contrast discrimination.,"['Vision (ENIGMA-Vis', 'Eligibility criteria are healthy non-smokers not diagnosed with substance abuse and without an acute or chronic medical condition', '100 participants']","['nicotine gum', 'Nicotine Gum Administration', 'placebo gum', 'nicotine', 'placebo']","['chromatic contrast discrimination', 'contrast sensitivity and chromatic contrast discrimination', 'contrast sensitivity', 'demographics, body mass index, or serum cotinine predicts response of visual processing']","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0589087', 'cui_str': 'Visual processing'}]",100.0,0.0375121,One of the main takeaways of this study is to understand the effects of nicotine on contrast sensitivity and chromatic contrast discrimination.,"[{'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Jeffery K', 'Initials': 'JK', 'LastName': 'Hovis', 'Affiliation': 'School of Optometry and Vision Science, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Jandirlly J S', 'Initials': 'JJS', 'LastName': 'Souto', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Thiago Augusto', 'Initials': 'TA', 'LastName': 'Bonifacio', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Stephanye', 'Initials': 'S', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Gabriella Medeiros', 'Initials': 'GM', 'LastName': 'Silva', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Michael Oliveira', 'Initials': 'MO', 'LastName': 'Andrade', 'Affiliation': 'Perception, Neuroscience and Behaviour Laboratory, Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Jessica Bruna', 'Initials': 'JB', 'LastName': 'Silva', 'Affiliation': 'Perception, Neuroscience and Behaviour Laboratory, Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, João Pessoa, Brazil.'}, {'ForeName': 'Milena Edite', 'Initials': 'ME', 'LastName': 'Oliveira', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Eveline Holanda', 'Initials': 'EH', 'LastName': 'Lima', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Maria Eduarda', 'Initials': 'ME', 'LastName': 'Gomes', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Marcos V A', 'Initials': 'MVA', 'LastName': 'Junior', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Mariana Lopes', 'Initials': 'ML', 'LastName': 'Martins', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, Brazil.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00314']
1430,33100988,Brain Network Modularity Predicts Improvements in Cognitive and Scholastic Performance in Children Involved in a Physical Activity Intervention.,"Introduction : Brain network modularity is a principle that quantifies the degree to which functional brain networks are divided into subnetworks. Higher modularity reflects a greater number of within-module connections and fewer connections between modules, and a highly modular brain is often interpreted as a brain that contains highly specialized brain networks with less integration between networks. Recent work in younger and older adults has demonstrated that individual differences in brain network modularity at baseline can predict improvements in performance after cognitive and physical interventions. The use of brain network modularity as a predictor of training outcomes has not yet been examined in children.  Method : In the present study, we examined the relationship between baseline brain network modularity and changes (post-intervention performance minus pre-intervention performance) in cognitive and academic performance in 8- to 9-year-old children who participated in an after-school physical activity intervention for 9 months ( N  = 78) as well as in children in a wait-list control group ( N  = 72).  Results : In children involved in the after-school physical activity intervention, higher modularity of brain networks at baseline predicted greater improvements in cognitive performance for tasks of executive function, cognitive efficiency, and mathematics achievement. There were no associations between baseline brain network modularity and performance changes in the wait-list control group.  Discussion : Our study has implications for biomarkers of cognitive plasticity in children. Understanding predictors of cognitive performance and academic progress during child development may facilitate the effectiveness of interventions aimed to improve cognitive and brain health.",2020,"In children involved in the after-school physical activity intervention, higher modularity of brain networks at baseline predicted greater improvements in cognitive performance for tasks of executive function, cognitive efficiency, and mathematics achievement.","['children', '8- to 9-year-old children who participated in an after-school physical activity intervention for 9 months ( N  = 78) as well as in children in a wait-list control group ( N  = 72', 'Discussion ', 'younger and older adults']",[],"['Cognitive and Scholastic Performance', 'modularity of brain networks', 'cognitive performance for tasks of executive function, cognitive efficiency, and mathematics achievement', 'cognitive and academic performance', 'baseline brain network modularity and performance changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.037683,"In children involved in the after-school physical activity intervention, higher modularity of brain networks at baseline predicted greater improvements in cognitive performance for tasks of executive function, cognitive efficiency, and mathematics achievement.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Chaddock-Heyman', 'Affiliation': 'Beckman Institute, The University of Illinois at Urbana-Champaign, Urbana, IL, United States.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department of Diagnostic Medicine, The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Kienzler', 'Affiliation': 'Department of Psychology, University of Colorado, Denver, CO, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weisshappel', 'Affiliation': 'Beckman Institute, The University of Illinois at Urbana-Champaign, Urbana, IL, United States.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Drollette', 'Affiliation': 'Department of Kinesiology, The University of North Carolina at Greensboro, Greensboro, NC, United States.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Raine', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Westfall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Shih-Chun', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Baniqued', 'Affiliation': 'Helen Wills Neuroscience Institute, University of California, Berkeley, Berkeley, CA, United States.'}, {'ForeName': 'Darla M', 'Initials': 'DM', 'LastName': 'Castelli', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Beckman Institute, The University of Illinois at Urbana-Champaign, Urbana, IL, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00346']
1431,33100989,Individual Baseline Performance and Electrode Montage Impact on the Effects of Anodal tDCS Over the Left Dorsolateral Prefrontal Cortex.,"Anodal transcranial direct current stimulation (tDCS), applied over the left dorsolateral prefrontal cortex (lDLPFC), can produce significant effects on working memory (WM) performance and associated neurophysiological activity. However, results from previous studies are inconsistent and occasionally contradictory. This inconsistency may be attributed to methodological and individual differences during experiments. This study therefore investigated two hypotheses: (1) A multichannel-optimized montage was expected to be more effective than a classical bipolar montage, because of increased focality. (2) The subjects were expected to benefit differently from the stimulation depending on their initial task performance. In a sham-controlled crossover study, 24 healthy participants received bipolar, multichannel, and sham stimulation for 20 min in randomized order, targeting the lDLPFC while performing a 2-back WM task. After stimulation, electroencephalography (EEG) was recorded at rest and during 2-back and nontarget continuous performance task (CPT) performance. Bipolar and multichannel stimulations were both well tolerated and effectively blinded. We found no effect of stimulation on behavioral performance or neuronal oscillations comparing the classical bipolar or multichannel montage with sham stimulation. We did, however, find an interaction between stimulation and initial task performance. For multichannel stimulation, initially low-performing participants tended to improve their WM performance while initially high-performing participants tended to worsen their performance compared to sham stimulation. Both tDCS montages induced changes in neural oscillatory power, which correlated with baseline performance. The worse the participants' initial WM performance was, the more task-related theta power was induced by multichannel and bipolar stimulation. The same effect was observed for alpha power in the nontarget task following multichannel stimulation. Notably, we were not able to show a superiority of multichannel stimulation compared to bipolar stimulation. Still, comparing both montages with sham stimulation, multichannel stimulation led to stronger effects than bipolar stimulation. The current study highlights the importance of investigating different parameters with potential influence on tDCS effects in combination. Our results demonstrate how individual differences in cognitive performance and electrode montages influence effects of tDCS on neuropsychological performance. These findings support the idea of an individualized and optimized stimulation setting, potentially leading to increased tDCS effects.",2020,We found no effect of stimulation on behavioral performance or neuronal oscillations comparing the classical bipolar or multichannel montage with sham stimulation.,['24 healthy participants received'],"['Anodal transcranial direct current stimulation (tDCS', 'Anodal tDCS', 'lDLPFC while performing a 2-back WM task', 'classical bipolar or multichannel montage with sham stimulation', 'bipolar, multichannel, and sham stimulation', 'tDCS']","['electroencephalography (EEG', 'neural oscillatory power', 'neuropsychological performance', 'WM performance', 'working memory (WM) performance and associated neurophysiological activity', 'behavioral performance or neuronal oscillations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}]",24.0,0.046554,We found no effect of stimulation on behavioral performance or neuronal oscillations comparing the classical bipolar or multichannel montage with sham stimulation.,"[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Splittgerber', 'Affiliation': 'Institute of Medical Psychology and Medical Sociology, University Medical Center-Schleswig Holstein, Kiel University, Kiel, Germany.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salvador', 'Affiliation': 'Neuroelectrics Barcelona, Barcelona, Spain.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Brauer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Center for Integrative Psychiatry Kiel, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Breitling-Ziegler', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Prehn-Kristensen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Center for Integrative Psychiatry Kiel, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Krauel', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Nowak', 'Affiliation': 'Neuroelectrics Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Moliadze', 'Affiliation': 'Institute of Medical Psychology and Medical Sociology, University Medical Center-Schleswig Holstein, Kiel University, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siniatchkin', 'Affiliation': 'Institute of Medical Psychology and Medical Sociology, University Medical Center-Schleswig Holstein, Kiel University, Kiel, Germany.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00349']
1432,33085686,An experimental study of messages communicating potential harms of electronic cigarettes.,"There has been an upsurge of e-cigarette use in the United States in recent years. While e-cigarettes may contain lower levels of toxic chemicals than combusted cigarettes, they still pose serious health hazards, including increased risk for heart and respiratory disease. Despite these risks, public awareness of the health harms of e-cigarettes remains low. Thus, it is important to educate the public about the potential harms of e-cigarettes. This study took themes commonly found in antismoking messages and used them to develop messages about harms of e-cigarettes. A national sample of 2801 current smokers and nonsmokers (aged 18+ years) were randomized to view one of four e-cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad). Participants' reactions to the messages and behavioral intentions were assessed immediately following the exposure. MANOVA examined effects of the messages on blocks of the outcome variables and univariate analyses estimated adjusted means for each experimental condition for each outcome. The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05). However, on measures of actual effectiveness, the other messages performed equally well. Specifically, messages with different themes (harmful chemicals, uncertainty about ingredients, anti-industry, or financial cost) increased perceived risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes (Ps<0.05). Themes commonly used in anti-smoking messages may be effective in educating the public about the potential harm of e-cigarettes. The observed differential effects of the messages suggest the need to use multiple themes in a public education campaign about e-cigarettes.",2020,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,['2801 current smokers and nonsmokers (aged 18+ years'],"['cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad']","['risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes', 'actual effectiveness']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2801.0,0.0207487,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Massey', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0240611']
1433,33085707,Does the size of rewards influence performance in cognitively demanding tasks?,"Classic micro-economic and psychology theories propose different implications of monetary incentives on performance. Empirical studies in sports settings show that athletes generally perform worse when the stakes are higher, while a range of lab studies involving cognitively demanding tasks have led to diverging results, supporting positive, negative and null-effects of higher (vs. lower) stakes. In order to further investigate this issue, we present a pre-registered, randomized, controlled trial of 149 participants solving both anagrams and math addition tasks. We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation. We propose that future studies should contrast the potential impact of rewards on different kinds of task, e.g. compare tasks that solely require cognitive effort vs. tasks that require motor skills, as in sports.",2020,"We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation.",['149 participants solving both anagrams and math addition tasks'],[],[],"[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],[],149.0,0.0711794,"We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation.","[{'ForeName': 'Joachim A', 'Initials': 'JA', 'LastName': 'Holst-Hansen', 'Affiliation': 'Department of Management, BSS, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bergenholtz', 'Affiliation': 'Department of Management, BSS, Aarhus University, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0240291']
1434,33086137,Effect of resin coating on highly viscous glass ionomer cements: A dynamic analysis.,"OBJECTIVES


This study determined the effects of self-adhesive resin coatings on viscoelastic properties of highly viscous glass ionomer cements (HVGICs) using dynamic mechanical analysis.
MATERIALS AND METHODS


The HVGICs evaluated were Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI). Sixty specimens (12mm x 2mm x 2mm) of each material were fabricated using customized Teflon molds. After initial set, the specimens were removed from their molds, finished, measured and randomly divided into 3 groups of 20. Half the specimens in each group were left uncoated while the remaining half was covered with the respective manufacturers' resin coating. The specimens were subsequently conditioned in distilled water, artificial saliva or citric acid at 37°C for 7 days. The uncoated and coated specimens (n=10) were then subjected to dynamic mechanical testing in flexure mode at 37°C with a frequency of 0.1 to 10Hz. Storage modulus, loss modulus and loss tangent data were subjected to normality testing and statistical analysis using one-way ANOVA/Scheffe's post-hoc test and Ttest at significance level p<0.05.
RESULTS


Mean storage modulus ranged from 1.39 ± 0.36 to 10.80 ± 0.86 GPa while mean loss modulus varied from 0.13 ± 0.03 to 0.70 ± 0.14 GPa after conditioning in the different mediums. Values for loss tangent ranged from 39.4 ± 7.75 to 213.2 ± 20.11 (x10 -3 ). Significant differences in visco-elastic properties were observed between mediums and materials. When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated. Significantly higher values were, however, observed with resin coating when the materials were exposed to citric acid.
CONCLUSION


The visco-elastic properties of HVGICs were influenced by both resin coating and chemical environment.",2020,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.",['highly viscous glass ionomer cements'],"['resin coating', 'self-adhesive resin coatings', 'distilled water, artificial saliva or citric acid']","['ZR, EQ and RV', 'Storage modulus, loss modulus and loss tangent data', 'visco-elastic properties', 'Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.033953,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Yap', 'Affiliation': 'Department of Dentistry, Ng Teng Fong General Hospital, National University Health System, Singapore; Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia; Faculty of Dentistry, National University of Singapore, Singapore; Duke-NUS Medical School, Singapore; National Dental Research Institute Singapore, National Dental Centre Singapore, Singapore.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Ong', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Yahya', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia. Electronic address: nazlin@um.edu.my.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104120']
1435,33086144,Behavioral activation with mindfulness in treating subthreshold depression in primary care: A cost-utility and cost-effectiveness analysis alongside a randomized controlled trial.,"This study aimed to assess the cost-utility and cost-effectiveness of group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU) for treating subthreshold depression in primary care. Adults aged 18 years or older with subthreshold depression were randomized into two arms and were followed up for 12 months. BAM group was provided with eight 2-h weekly treatment by trained allied healthcare workers. CAU group could access to usual medical care but did not receive extra interventions. The health service cost in the past 12 months was self-reported by the participants. Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression) were measured. Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA) was US$50,000 per QALY and US$20,000 per prevented major depression case, respectively. These ratios were used in the cost-effective acceptability curve analyses to estimate the probability of cost-effectiveness of the estimated incremental cost effectiveness ratios (ICER) of BAM versus CAU. A total of 115 and 116 participants were included in the BAM group and CAU respectively. The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU. Furthermore, when compared to CAU, BAM was cost-effective in preventing progression of major depression: the estimated CEA ICER was US$1046 per preventable case of major progression with a probability of 0.99 to be cost-effective. Group-based BAM is considered as a cost-effective alternative treatment for treating subthreshold depression by preventing major depressive disorder.",2020,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","['A total of 115 and 116 participants were included in the BAM group and CAU respectively', 'primary care', 'Adults aged 18 years or older with subthreshold depression']","['group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU', 'CAU', 'BAM']","['estimated CUA ICER', 'health service cost', 'Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression', 'Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA', 'cost-utility and cost-effectiveness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",,0.0462248,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","[{'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China; School of Public Health, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cynthia H J', 'Initials': 'CHJ', 'LastName': 'Chen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China. Electronic address: benyip@cuhk.edu.hk.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.006']
1436,33086145,Bifrontal high-frequency transcranial random noise stimulation is not effective as an add-on treatment in depression.,"BACKGROUND


Depressive disorders are linked to dysfunction in prefrontal cortical areas. Hence, non-invasive neurostimulation of the prefrontal cortex has demonstrated antidepressant efficacy. In the present study, we investigated the efficacy of high frequency transcranial random noise stimulation (hf-tRNS) as an add-on treatment for depression in a sham-controlled randomized trial.
METHODS


Forty in-patients with depression were randomized and treated with real or sham hf-tRNS (100-650 Hz) with 0 mA offset. The electrodes were mounted over the left and right dorsolateral prefrontal cortex. The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention. Safety parameters included cognitive functioning and reported side-effects.
RESULTS


Comparison of real and sham treatment at the planned interim analysis showed an amelioration of symptoms in both groups for all outcomes with numeric but not statistically significant superiority of the sham arm for the primary outcome. Thus, the study was terminated prematurely after an interim analysis. There were no systematic differences with respect to safety parameters.
LIMITATIONS


The negative finding might be related to the specific stimulation parameters used in this study.
CONCLUSIONS


Our study suggests that prefrontal hf-tRNS is safe but not effective as an add-on treatment of depression. The challenge for future studies employing transcranial electric stimulation remains to identify effective stimulation parameters for the treatment of depression.",2020,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.",['Forty in-patients with depression'],"['transcranial electric stimulation', 'real or sham hf-tRNS', 'high frequency transcranial random noise stimulation (hf-tRNS']","['Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale', 'cognitive functioning and reported side-effects', 'amelioration of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0424188,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: martin.schecklmann@medbo.de.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Iran.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Germany.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Peytard', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Wetter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.011']
1437,33086156,Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.,"BACKGROUND


In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-term SM ) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.
METHODS


HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.
DISCUSSION


To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.",2020,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.",[],"['CTH intervention', 'HEAL (CTH) intervention', 'CTH']","['monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0247065,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Section of Infectious Diseases and Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2014, Boston, MA, 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: lg123@columbia.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Huerta', 'Affiliation': 'College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: timothy.huerta@osumc.edu.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Oser', 'Affiliation': 'Department of Sociology and Center on Drug and Alcohol Research, University of Kentucky, 1531 Patterson Office Tower, Lexington, KY, 40506, USA. Electronic address: carrie.oser@uky.edu.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Aldrich', 'Affiliation': 'CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: alison.aldrich@osumc.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2030, Boston, MA, 02118, USA. Electronic address: ecrable@bu.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: bgarner@rti.org.'}, {'ForeName': 'LaShawn M', 'Initials': 'LM', 'LastName': 'Glasgow', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: lglasgow@rti.org.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: dg2121@columbia.edu.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Marks', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, 1100 Veterans Drive, Medical Behavioral Science Building Room 108, Lexington, KY, 40536, USA. Electronic address: katie.marks@uky.edu.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Department of Family and Community Medicine and CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: ann.mcalearney@osumc.edu.'}, {'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Oga', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: eoga@rti.org.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Department of Infectious Disease, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, USA. Electronic address: ariel.scalise@bmc.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 520, Columbus, OH, 43210, USA. Electronic address: daniel.walker@osumc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108330']
1438,33086159,Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience.,"The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. We propose a systematic approach using the artificial intelligence tools to identifying risk factors and subgroups contributing to the overall death (prognostic) or to the excess death observed in the pembrolizumab plus SOC arm (predictive) of the KEYNOTE-183 study. In KEYNOTE-183, with a data cutoff date of June 02, 2017, we identified plasmacytoma as a prognostic factor, and ECOG performance status as a predictive factor of death. In addition, a qualitative interaction was observed between ECOG performance status and the treatment arm. The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.",2020,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,['patients with refractory or relapsed and refractory multiple myeloma (rrMM'],['dexamethasone (standard-of-care [SOC]) with or without pembrolizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0440892,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,"[{'ForeName': 'Jason J Z', 'Initials': 'JJZ', 'LastName': 'Liao', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA. Electronic address: a4statistics@gmail.com.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hartzel', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keaven', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Junshui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Gause', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106179']
1439,33087441,Beta blockers versus calcium channel blockers for provocation of vasospastic angina after drug-eluting stent implantation: a multicentre prospective randomised trial.,"BACKGROUND


Drug-eluting stent-induced vasospastic angina (DES-VSA) has emerged as a novel complication in the modern era of percutaneous coronary intervention (PCI). Although beta blockers (BBs) are generally recommended for coronary heart disease, they may promote incidence of DES-VSA. This study aimed to compare the effects of calcium channel blockers (CCBs) perceived to be protective against DES-VSA and BBs on subsequent coronary events after second-generation drug-eluting stent implantation.
METHODS


In this multicentre prospective, randomised study, 52 patients with coronary artery disease who underwent PCI for a single-vessel lesion with everolimus-eluting stent placement were randomised into post-stenting BB (N=26) and CCB (N=26) groups and followed for 24 months to detect any major cardiovascular events (MACE). A positive result on acetylcholine provocation testing during diagnostic coronary angiography (CAG) at 9 months was the primary endpoint for equivalence. MACE included all-cause death, non-fatal myocardial infarction, unstable angina, cerebrovascular disease or coronary revascularisation for stable coronary artery disease after index PCI.
RESULTS


At 9 months, 42 patients (80.8%) underwent diagnostic coronary angiography and acetylcholine provocation testing. Among them, seven patients in each group were diagnosed with definite vasospasm (intention-to-treat analysis 26.9% vs 26.9%, risk difference 0 (-0.241, 0.241)). Meanwhile, the secondary endpoint, 24-month MACE, was higher in the CCB group (19.2%) than in the BB group (3.8%) (p=0.01). In detail, coronary revascularisation for stable coronary artery disease was the predominant endpoint that contributed to the greater proportion of MACE in the CCB group (CCB (19.2%) vs BB (3.8%), p=0.03).
CONCLUSIONS


The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI. However, a higher incidence of 2-year MACE was observed in the CCB group, suggesting the importance of BB administration.
TRIAL REGISTRATION NUMBER


This study was registered at the Japanese University Hospital Medical Information Network (UMIN) Clinical Trial Registry (The Prospective Randomized Trial for Optimizing Medical Therapy After Stenting: Calcium-Beta Trial; UMIN000008321, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009536).",2020,The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI.,"['Japanese University Hospital Medical Information Network (UMIN', '52 patients with coronary artery disease who underwent PCI for a single-vessel lesion with everolimus-eluting stent placement', 'vasospastic angina after drug-eluting stent implantation']","['MACE', 'calcium channel blockers', 'CCB', 'post-stenting BB', 'calcium channel blockers (CCBs', 'beta blockers (BBs', 'Medical Therapy', 'diagnostic coronary angiography and acetylcholine provocation testing', 'Beta blockers', 'diagnostic coronary angiography (CAG']","['incidence of acetylcholine-induced coronary artery spasms', 'diagnosed with definite vasospasm', 'cause death, non-fatal myocardial infarction, unstable angina, cerebrovascular disease or coronary revascularisation', '2-year MACE']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",52.0,0.125692,The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI.,"[{'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Sawano', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Toshiomi', 'Initials': 'T', 'LastName': 'Katsuki', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kitai', 'Affiliation': 'Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Tamita', 'Affiliation': 'Department of Cardiology, Nishinomiya Watanabe Cardiovascular Center, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Obunai', 'Affiliation': 'Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Ichikawa, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ikegami', 'Affiliation': 'Department of Cardiology, National Hospital Organisation Tokyo Medical Center, Meguro-ku, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiology, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Cardiology, International University of Health and Welfare Faculty of Medicine Graduate School of Medicine, Narita, Chiba, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan sk@keio.jp.'}]",Open heart,['10.1136/openhrt-2020-001406']
1440,33091202,The efficacy and safety of topical tranexamic acid (liposomal or lotion with microneedling) versus conventional hydroquinone in the treatment of melasma.,"BACKGROUND


Robust evidence regarding the efficacy of topical tranexamic acid (TA) on melasma in Chinese population is lacking.
OBJECTIVE


To evaluate the efficacy and safety of 1.8% liposomal TA and microneedling with 5% TA solution on melasma.
METHODS


Sixty melasma patients were enrolled and randomized to receive 1.8% liposomal TA twice daily, microneedling with 5% TA solution weekly or 2% hydroquinone every night. Objective and subjective assessments were obtained at baseline, 4, 8 and 12 weeks.
RESULTS


27.8% of patients of liposomal TA group, 33.3% of microneedling with TA solution group and 30.0% of hydroquinone group were recognized as ""more than 50% improvement"". At the endpoint, the melanin index (MI) in all treatment groups were significantly decreased, while the improvement of MI in microneedling with TA solution group and hydroquinone group is higher than liposomal TA group. The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group. Dermatoscopy and reflectance confocal microscopy revealed decreased brown granules in all groups and reduced telangiectasia in liposomal TA group and microneedling with TA solution group.
CONCLUSION


1.8% liposomal TA and microneedling with 5% TA solution are both effective and safe on melasma.",2020,The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group.,['Sixty melasma patients'],"['hydroquinone', 'liposomal TA and microneedling with 5% TA solution', 'topical tranexamic acid (TA', 'liposomal TA', 'topical tranexamic acid (liposomal or lotion with microneedling) versus conventional hydroquinone', 'liposomal TA twice daily, microneedling with 5% TA solution weekly or 2% hydroquinone every night']","['Objective and subjective assessments', 'efficacy and safety', 'melanin index (MI', 'erythema index (EI', 'effective and safe on melasma']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]",60.0,0.0334802,The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group.,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xing', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Shanglin', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Chengfeng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Leihong', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13810']
1441,33091585,Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.,"Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.",2020,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","['Eligible participants (aged ≥30\u202fyears and without an existing AF diagnosis) registered at participating UK general practices', 'undiagnosed atrial fibrillation patients']","['12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device', 'machine learning risk prediction algorithm and diagnostic testing (PULsE-AI']",['number of AF diagnoses'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.124353,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Hill', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Nathan.Hill@bms.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Arden', 'Affiliation': 'Park Surgery, Chandlers Ford, Hampshire, UK. Electronic address: chrisarden@nhs.net.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beresford-Hulme', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: l.m.beresford91@googlemail.com.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George's University of London, London, UK. Electronic address: jcamm@sgul.ac.uk.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clifton', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, UK. Electronic address: davidc@robots.ox.ac.uk.'}, {'ForeName': 'D Wyn', 'Initials': 'DW', 'LastName': 'Davies', 'Affiliation': ""St Mary's Hospital, London, UK.""}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Farooqui', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Usman.Farooqui@bms.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: jason.gordon@heor.co.uk.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Groves', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: lara.groves@heor.co.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: michael.hurst@heor.co.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: s.a.lawton@keele.ac.uk.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lister', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Steven.Lister@bms.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: c.d.mallen@keele.ac.uk.'}, {'ForeName': 'Anne-Celine', 'Initials': 'AC', 'LastName': 'Martin', 'Affiliation': 'Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges Pompidou, Service de Cardiologie, 20 rue Leblanc, Paris, France.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: phil.mcewan@heor.co.uk.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Pollock', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Kevin.Pollock@bms.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rogers', 'Affiliation': 'PHASTAR, London, UK. Electronic address: jennifer.rogers@phastar.com.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Sandler', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Belinda.Sandler@bms.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sugrue', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: daniel.sugrue@heor.co.uk.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK. Electronic address: alexander.cohen@kcl.ac.uk.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106191']
1442,33091807,Modality effects in verbal working memory updating: Transcranial direct current stimulation over human inferior frontal gyrus and posterior parietal cortex.,"Verbal working memory (VWM) involves visual and auditory verbal information. Neuroimaging studies have shown significant modality effects for VWM in the left posterior parietal cortex (PPC). The left inferior frontal gyrus (IFG) is more sensitive to auditory and phonological information. However, much less is known about the effects of transcranial direct current stimulation (tDCS) over the left PPC and IFG on different sensory modalities of VWM (auditory vs. visual). Therefore, the present study aimed to examine whether tDCS over the left PPC and IFG affects visual and auditory VWM updating performance using a single-blind design. Fifty-one healthy participants were randomly assigned to three tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks. Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition. Anodal stimulation to the left IFG improved the response efficiency of both tasks. The present study revealed a modality effect of VWM in the left PPC, while the left IFG had a causal role in VWM updating of different sensory modalities.",2020,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.",['Fifty-one healthy participants'],"['tDCS', 'tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks', 'transcranial direct current stimulation (tDCS']","['response efficiency of visual', 'Verbal working memory (VWM) involves visual and auditory verbal information']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456856', 'cui_str': 'Left posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",51.0,0.031288,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.","[{'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Yangmei', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Xuqun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China. Electronic address: youxuqun@snnu.edu.cn.""}]",Brain and cognition,['10.1016/j.bandc.2020.105630']
1443,33091844,Operationalizing and selecting outcome measures for the HEALing Communities Study.,"BACKGROUND


The Helping to End Addiction Long-term SM  (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.
METHODS


Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.
RESULTS


The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.
CONCLUSIONS


The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.",2020,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,[],"['buprenorphine', 'HEAL intervention']","['support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths', 'number of opioid overdose deaths, will be measured from death certificate data']",[],"[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011066', 'cui_str': 'Death certificate'}]",,0.102551,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,"[{'ForeName': 'Svetla', 'Initials': 'S', 'LastName': 'Slavova', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Healthy Kentucky Research Building RB2, Suite 260, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: ssslav2@email.uky.edu.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'LaRochelle', 'Affiliation': 'Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02218, USA. Electronic address: marc.larochelle@bmc.org.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Root', 'Affiliation': 'Department of Geography and Division of Epidemiology, The Ohio State University, and Translational Data Analytics Institute Columbus, The Ohio State University, 1036 Derby Hall, 154 N. Oval Mall, Columbus, OH, 43210, USA. Electronic address: root.145@osu.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Room 1059, Miami, FL, 33136, USA. Electronic address: dfeaster@med.miami.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, 3WFN, MSC 6025, 301 North Stonestreet Avenue, Bethesda, MD, 20892, USA. Electronic address: jennifer.villani@nih.gov.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Knott', 'Affiliation': 'Social, Statistical and Environment Sciences Survey Research Division, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA. Electronic address: cknott@rti.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Talbert', 'Affiliation': 'Division of Biomedical Informatics, University of Kentucky College of Medicine, 267 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: jeff.talbert@uky.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Aimee.mack@osumc.edu.'}, {'ForeName': 'Dushka', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Dushka.crane@osumc.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bernson', 'Affiliation': 'Massachusetts Department of Public Health, 250 Washington Street, Boston, MA, 02108, USA. Electronic address: Dana.Bernson@mass.gov.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 900, Rockville, MD, 20852, USA. Electronic address: abooth@rti.org.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA. Electronic address: sharon.walsh@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108328']
1444,33091856,"Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind, randomized, placebo-controlled trial.","BACKGROUND


Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.
MATERIALS AND METHODS


In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.
RESULTS


In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
CONCLUSIONS


Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.",2020,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","['66 subjects diagnosed as having OAB were enrolled and treated with a', 'overactive bladder (OAB', 'n=33) or CP (n=33', '66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the\xa0intention-to-treat analyses']","['placebo', 'cinnamon patch (CP', 'cinnamon patch treatment', 'CP']","['OAB symptom score (OABSS', 'efficacy and safety', 'patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume', 'alleviating symptoms of overactive bladder', 'OABSS scores', 'USS scores', 'PPBC scores']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",66.0,0.50229,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","[{'ForeName': 'Lih-Lian', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Yuh-Chiang', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan; National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan.'}, {'ForeName': 'Chih-Chun', 'Initials': 'CC', 'LastName': 'Ke', 'Affiliation': 'Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Zuha', 'Initials': 'Z', 'LastName': 'Imtiyaz', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Hui-I', 'Initials': 'HI', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Chin-Hsien', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan; Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Mei-Hsien', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan. Electronic address: lmh@tmu.edu.tw.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153380']
1445,33091857,"A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.
HYPOTHESIS/PURPOSE


As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.
STUDY DESIGN


A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.
METHODS


This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays, corresponding to 12-24 mg of polyphenols, three times for five days. The duration of the study was 8 weeks.
RESULTS


After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
CONCLUSION


Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.",2020,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","['uncomplicated upper respiratory tract infection (URTI', '122 healthy adults who had perceived mild upper respiratory tract infections']","['propolis oral spray (N\xa0=\xa058) or placebo', 'standardized polyphenol mixture extracted from poplar-type propolis', 'placebo']",['remission of symptoms'],"[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",122.0,0.301597,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Emanuele Ugo', 'Initials': 'EU', 'LastName': 'Garzarella', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bocchino', 'Affiliation': 'Samnium Medical Soc. Cooperative, 82100 Benevento, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Avino"", 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Antonio Riccardo', 'Initials': 'AR', 'LastName': 'Buonomo', 'Affiliation': 'Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galeotti', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zaccaria', 'Affiliation': 'B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglia', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153368']
1446,33101178,REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in Catalonia: REMOTE-CAT PROJECT.,"Rationale:  Remote ischemic perconditioning during cerebral ischemia (RIPerC) refers to the application of brief episodes of transient limb ischemia commonly to a limb, it represents a new safe, simple and low-cost paradigm in neuroprotection.  Aim and/or Hypothesis:  To evaluate the effects of RIPerC on acute ischemic stroke (AIS) patients, applied in the ambulance, to improve functional outcomes compared with standard of care.  Sample Size Estimates:  A sample size of 286 patients in each arm achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%.  Methods and Design:  We aim to conduct a multicentre study of pre-hospital RIPerC application in AIS patients. A total of 572 adult patients diagnosed of suspected clinical stroke within 8 h of symptom onset and clinical deficit >0 according to prehospital rapid arterial occlusion evaluation (RACE) scale score will be randomized, in blocks of size 4, to RIPerC or sham. Patients will be stratified by RACE score scale. RIPerC will be started in the ambulance before hospital admission and continued in the hospital if necessary. It will consist of five cycles of electronic tourniquet inflation and deflation (5 min each). The cuff pressure for RIPerC will be 200 mmHg during inflation. Sham will only simulate vibration of the device.  Study Outcome(s):  The primary outcome will be the difference in the proportion of patients with good outcomes as defined by a mRS score of 2 or less at 90 days. Secondary outcomes to be monitored will include early neurological improvement rate, treatment related serious adverse event rates, size of the infarct volume, symptomatic intracranial hemorrhage, metabolomic and lipidomic response to RIPerC and Neuropsychological evaluation at 90 days.  Discussion:  Neuroprotective therapies could not only increase the benefits of available reperfusion therapies among AIS patients but also provide an option for patients who are not candidates for these treatments. REMOTE-CAT will investigate the clinical benefit of RIC as a new neuroprotective strategy in AIS.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03375762.",2020,"achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%.  ","['acute ischemic stroke (AIS) patients', '286 patients in each arm', 'Acute Ischemic Stroke Patients in Catalonia', '572 adult patients diagnosed of suspected clinical stroke within 8 h of symptom onset and clinical deficit >0 according to prehospital rapid arterial occlusion evaluation (RACE) scale score', 'AIS patients']",['RIPerC'],"['initial misdiagnosis rate', 'cuff pressure', 'early neurological improvement rate, treatment related serious adverse event rates, size of the infarct volume, symptomatic intracranial hemorrhage, metabolomic and lipidomic response to RIPerC and Neuropsychological evaluation at 90 days']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",572.0,0.207388,"achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%.  ","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Purroy', 'Affiliation': 'Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Arque', 'Affiliation': 'Clinical Neurosciences Group, Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Mauri', 'Affiliation': 'Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'García-Vázquez', 'Affiliation': 'Clinical Neurosciences Group, Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Vicente-Pascual', 'Affiliation': 'Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pereira', 'Affiliation': 'Clinical Neurosciences Group, Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vazquez-Justes', 'Affiliation': 'Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Torres-Querol', 'Affiliation': 'Clinical Neurosciences Group, Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vena', 'Affiliation': 'Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'Sònia', 'Initials': 'S', 'LastName': 'Abilleira', 'Affiliation': 'Stroke Programme, Agency for Health Quality and Assessment of Catalonia, CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Cardona', 'Affiliation': 'Stroke Unit, Hospital de Bellvitge, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Forné', 'Affiliation': 'Department of Basic Medical Sciences, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jiménez-Fàbrega', 'Affiliation': ""Servei d'Emergències Mèdiques, Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pagola', 'Affiliation': ""Stroke Unit, Neurology Department, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Portero-Otin', 'Affiliation': 'Department of Experimental Medicine, NUTREN-Nutrigenomics, Biomedical Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodríguez-Campello', 'Affiliation': ""Neurovascular Research Group, Neurology Department, Institut Hospital del Mar d'Investigacions Mèdiques-Hospital del Mar, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Àlex', 'Initials': 'À', 'LastName': 'Rovira', 'Affiliation': ""Section of Neuroradiology and MRI Unit, Department of Radiology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Stroke Unit, Hospital de Sant Pau, Barcelona, Spain.'}]",Frontiers in neurology,['10.3389/fneur.2020.569696']
1447,33101194,Hormone Replacement Versus Natural Cycle Protocols of Endometrial Preparation for Frozen Embryo Transfer.,"Research question


Endometrial preparation is one of the most important steps for ensuring frozen embryo transfer success. However, there is no clear evidence that identifies an optimal endometrial preparation protocol for frozen embryo transfer. In addition, in studies that assessed which were the optimal endometrial preparation protocols, few analyzed the stage and the number of embryos. This study compared the pregnancy outcomes and perinatal obstetric complications of patients who were transferred two cleavage-stage (day 2 or day 3) frozen embryos with the natural cycle and those with the hormone replacement therapy cycle.
Design


This study was a secondary analysis of data from a multicentre randomized controlled trial designed to compare the pregnancy and perinatal outcomes after frozen versus fresh embryo transfer. In this study, a total of 908 patients who were transferred two cleavage-stage (day 2 or day 3) embryos in the original trial were analyzed. Pregnancy outcomes and perinatal obstetric complications after the natural cycle and the hormone replacement therapy cycle were compared.
Result


We found the endometrium in the natural group was significantly thicker than the hormone replacement therapy cycle group ( p <0.01). The implantation rate (42.6% vs 37.3%  p =0.049) showed a significant difference between the natural cycle group and the hormone replacement therapy cycle group. Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5,  p =0.009).
Conclusion


The natural cycle protocol yielded thicker endometria, a higher implantation rate and a lower risk of caesarean section than the hormone replacement therapy protocol in the transfer of two cleavage-stage frozen embryos. The natural cycle protocol was the better endometrial preparation protocol for frozen embryo transfer.",2020,"Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5,  p =0.009).
","['908 patients who were transferred two cleavage-stage (day\xa02\xa0or\xa0day\xa03) embryos in the original trial were analyzed', 'patients who were transferred two cleavage-stage (day\xa02\xa0or\xa0day\xa03) frozen embryos with the natural cycle and those with the hormone replacement therapy cycle']","['frozen versus fresh embryo transfer', 'Hormone Replacement']","['pregnancy outcomes and perinatal obstetric complications', 'risk of caesarean section', 'implantation rate', 'implantation rate and a lower risk of caesarean section', 'Pregnancy outcomes and perinatal obstetric complications']","[{'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0440733', 'cui_str': 'Frozen embryo'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",908.0,0.088604,"Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5,  p =0.009).
","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.546532']
1448,33101202,Dynamic Changes in Circulating Endocrine FGF19 Subfamily and Fetuin-A in Response to Intralipid and Insulin Infusions in Healthy and PCOS Women.,"Background:  The fibroblast growth factors (FGF) 19 subfamily, also referred to as endocrine FGFs, includes FGF19, FGF21, and FGF23 are metabolic hormones involved in the regulation of glucose and lipid metabolism. Fetuin-A is a hepatokine involved in the regulation of beta-cell function and insulin resistance. Endocrine FGFs and fetuin-A are dysregulated in metabolic disorders including obesity, type 2 diabetes, non-alcoholic fatty liver disease and polycystic ovary syndrome (PCOS). Our study was designed to examine the response of endocrine FGFs and fetuin-A to an acute intralipid, insulin infusion and exercise in PCOS and healthy women.  Subjects and Measurements:  Ten healthy and 11 PCOS subjects underwent 5-h saline infusions with a hyperinsulinemic-euglycemic clamp (HIEC) performed during the final 2 h. One week later, intralipid infusions were undertaken with a HIEC performed during the final 2 h. After an 8 week of exercise intervention the saline, intralipid, and HIEC were repeated. Plasma levels of endocrine FGFs and fetuin-A were measured.  Results:  Baseline fetuin-A was higher in PCOS women but FGF19, FGF21, and FGF23 did not differ and were unaffected by exercise. Insulin administration elevated FGF21 in control and PCOS, suppressed FGF19 in controls, and had no effects on FGF23 and fetuin-A. Intralipid infusion suppressed FGF19 and increased FGF21. Insulin with intralipid synergistically increased FGF21 and did not have effects on lipid-mediated suppression of FGF19 in both groups.  Conclusion:  Our study provides evidence for insulin and lipid regulation of endocrine FGFs in healthy and PCOS women, suggesting that FGF family members play a role in lipid and glucose metabolism.  Clinical Trial Registration:  www.isrctn.org, Identifier: ISRCTN42448814.",2020,"Baseline fetuin-A was higher in PCOS women but FGF19, FGF21, and FGF23 did not differ and were unaffected by exercise.","['Healthy and PCOS Women', 'PCOS and healthy women', 'Ten healthy and 11 PCOS subjects', 'healthy and PCOS women']","['Insulin with intralipid', 'saline infusions with a hyperinsulinemic-euglycemic clamp (HIEC', 'exercise intervention the saline, intralipid, and HIEC', 'acute intralipid, insulin infusion and exercise']",['Plasma levels of endocrine FGFs and fetuin-A'],"[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}]",10.0,0.0454928,"Baseline fetuin-A was higher in PCOS women but FGF19, FGF21, and FGF23 did not differ and were unaffected by exercise.","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Ramanjaneya', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Milin', 'Initials': 'M', 'LastName': 'Bensila', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ilham', 'Initials': 'I', 'LastName': 'Bettahi', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Jayakumar', 'Initials': 'J', 'LastName': 'Jerobin', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Tareq A', 'Initials': 'TA', 'LastName': 'Samra', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Myint Myint', 'Initials': 'MM', 'LastName': 'Aye', 'Affiliation': 'Department of Academic Endocrinology, Diabetes and Metabolism, Hull York Medical School, Hull, United Kingdom.'}, {'ForeName': 'Meis', 'Initials': 'M', 'LastName': 'Alkasem', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Kodappully Sivaraman', 'Initials': 'KS', 'LastName': 'Siveen', 'Affiliation': 'Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Endocrinology, Diabetes and Metabolism, Hull York Medical School, Hull, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Skarulis', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Stephen Lawrence', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'Royal College of Surgeons in Ireland Bahrain, Busaiteen, Bahrain.'}, {'ForeName': 'Abdul-Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Qatar Metabolic Institute, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.568500']
1449,33101409,"Decreased Sex Hormone-Binding Globulin Indicated Worse Biometric, Lipid, Liver, and Renal Function Parameters in Women with Polycystic Ovary Syndrome.","Objective


To investigate the relationships between sex hormone-binding globulin (SHBG) and comprehensive metabolic parameters including biometric, glycemic, lipid, liver, and renal functions of women with polycystic ovary syndrome (PCOS).  Study Design and Methods . A total of 1000 women diagnosed as PCOS by modified Rotterdam criteria were enrolled in a randomized controlled trial. SHBG and comprehensive metabolic parameters were measured at the baseline visit. Metabolic parameters included biometric parameters, glucose and lipid panels, and liver and renal function parameters. An independent  t -test and linear regression were performed to investigate the associations between SHBG and metabolic parameters. Logistic regression was used to detect the relationship between SHBG and the presence of metabolic syndrome.
Results


In comparative analyses, PCOS women with lower SHBG levels had higher body mass index, waist circumference, insulin, homeostatic model assessment-insulin resistance (HOMA-IR) index, systolic and diastolic blood pressure, triglycerides, apolipoprotein B (APOB), low-density lipoprotein (LDL), aspartate transferase (AST), alanine transferase (ALT), and blood urea nitrogen (BUN), but lower high-density lipoprotein (HDL) and apolipoprotein A1 (APOA1). In linear regression, SHBG was inversely associated with waist circumference, systolic blood pressure, triglyceride, LDL, APOB, ALT, AST, and BUN but positively associated with HDL and APOA1 after adjusting the BMI. In logistic regression, SHBG is a protective predictor for metabolic syndrome (odds ratio = 0.96; 95% confidence interval: 0.95-0.97). The area under the receiver-operator characteristic curve is 0.732 with a 95% confidence interval of 0.695-0.770. SHBG <26.75 mmol/L is the cutoff point with the best Youden index, which has a sensitivity of 0.656 and specificity of 0.698.
Conclusions


Lower SHBG was associated with worsening biometric, lipid, liver, and renal functions but not glycemic parameters among women with PCOS. SHBG can be used as a tool to screen metabolic syndrome. This trial is registered with NCT01573858 and ChiCTR-TRC-12002081.",2020,"In linear regression, SHBG was inversely associated with waist circumference, systolic blood pressure, triglyceride, LDL, APOB, ALT, AST, and BUN but positively associated with HDL and APOA1 after adjusting the BMI.","['Women with Polycystic Ovary Syndrome', '1000 women diagnosed as PCOS by modified Rotterdam criteria', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS']","['sex hormone-binding globulin (SHBG', 'SHBG']","['biometric parameters, glucose and lipid panels, and liver and renal function parameters', 'worsening biometric, lipid, liver, and renal functions', 'body mass index, waist circumference, insulin, homeostatic model assessment-insulin resistance (HOMA-IR) index, systolic and diastolic blood pressure, triglycerides, apolipoprotein B (APOB), low-density lipoprotein (LDL), aspartate transferase (AST), alanine transferase (ALT), and blood urea nitrogen (BUN), but lower high-density lipoprotein (HDL) and apolipoprotein A1 (APOA1', 'biometric, glycemic, lipid, liver, and renal functions', 'metabolic syndrome', 'SHBG and comprehensive metabolic parameters', 'waist circumference, systolic blood pressure, triglyceride, LDL, APOB, ALT, AST, and BUN']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0376147', 'cui_str': 'SGPT'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",1000.0,0.0545592,"In linear regression, SHBG was inversely associated with waist circumference, systolic blood pressure, triglyceride, LDL, APOB, ALT, AST, and BUN but positively associated with HDL and APOA1 after adjusting the BMI.","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Xin-Ming', 'Initials': 'XM', 'LastName': 'Yang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Wang-Yu', 'Initials': 'WY', 'LastName': 'Cai', 'Affiliation': 'The Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Hong-Li', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Xiao-Ke', 'Initials': 'XK', 'LastName': 'Wu', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}]",International journal of endocrinology,['10.1155/2020/7580218']
1450,33101444,"Effects of Qingshen Granules on Immune Function in Patients with Comorbid Chronic Renal Failure and Damp-Heat Syndrome: A Multicenter, Randomized, Controlled Trial.","Objective


The current study sought to compare the effects of the addition of Qingshen granules to conventional Western medicine on immune function in patients with comorbid chronic renal failure and damp-heat syndrome and to explore the possible mechanisms responsible for any differences observed.
Methods


Through a multicenter, randomized, controlled study, a total of 282 eligible patients were divided into experimental ( n  = 136) and control groups ( n  = 146). All of the patients were treated with conventional Western medical therapy. The experimental group also received Qingshen granules three times daily for 12 weeks. Clinical efficacy was observed in the two groups. Peripheral blood levels of CD4 +  T cells, CD8 +  T cells, Th17 cells, nuclear factor- κ B p65 (NF- κ B p65) activity, serum interleukin-17 (IL-17), serum interleukin-6 (IL-6), tumor necrosis factor- α  (TNF- α ), tumor necrosis factor receptor-associated factor 6 (TRAF6), fibronectin (FN), and type IV collagen (Col-IV) were detected in both groups.
Results


The total clinical curative effective rate was significantly higher ( p  < 0.05) in the experimental group (79.41%) than in the control group (67.12%). Before treatment, there were no significant differences in CD4 + /CD8 +  T cell ratio, Th17 cell level, NF- κ B p65 activity, serum IL-17, IL-6, TNF- α , TRAF6, FN, and Col-IV between the experimental and control groups ( p  > 0.05); however, all of the measures were significantly higher than those observed in a healthy comparison group ( p  < 0.05 or  p  < 0.01). After treatment, the above indexes in the experimental group were significantly lower than those before treatment ( p  < 0.05 or  p  < 0.01). Similarly, NF- κ B p65 activity, serum IL-17, TNF- α , TRAF6, FN, and Col-IV in the control group were significantly lower than the levels observed prior to treatment ( p  < 0.05 or  p  < 0.01); however, while all of the other indexes were lower than those observed before treatment, the differences were not statistically significant ( p  > 0.05).
Conclusion


Qingshen granules adjust immune dysfunction, improve immunity mediated inflammatory response, and attenuate renal fibrosis in patients with comorbid chronic renal failure and damp-heat syndrome.",2020,"Peripheral blood levels of CD4 +  T cells, CD8 +  T cells, Th17 cells, nuclear factor- κ B p65 (NF- κ B p65) activity, serum interleukin-17 (IL-17), serum interleukin-6","['patients with comorbid chronic renal failure and damp-heat syndrome', '282 eligible patients were divided into experimental ( n \u2009=\u2009136) and control groups ( n \u2009=\u2009146', 'Patients with Comorbid Chronic Renal Failure and Damp-Heat Syndrome']","['Qingshen granules to conventional Western medicine', 'conventional Western medical therapy', 'Qingshen Granules']","['IL-6), tumor necrosis factor', 'Immune Function', 'NF- κ B p65 activity, serum IL-17, TNF- α , TRAF6, FN, and Col-IV', 'α  (TNF- α ), tumor necrosis factor receptor-associated factor 6 (TRAF6), fibronectin (FN), and type IV collagen (Col-IV', 'total clinical curative effective rate', 'Peripheral blood levels of CD4 +  T cells, CD8 +  T cells, Th17 cells, nuclear factor- κ B p65 (NF- κ B p65) activity, serum interleukin-17 (IL-17), serum interleukin-6', 'CD4 + /CD8 +  T cell ratio, Th17 cell level, NF- κ B p65 activity, serum IL-17, IL-6, TNF- α , TRAF6, FN, and Col-IV', 'Clinical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0530129', 'cui_str': 'TRAF6'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0016055', 'cui_str': 'Fibronectin'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",282.0,0.0167077,"Peripheral blood levels of CD4 +  T cells, CD8 +  T cells, Th17 cells, nuclear factor- κ B p65 (NF- κ B p65) activity, serum interleukin-17 (IL-17), serum interleukin-6","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China.'}, {'ForeName': 'Chuanping', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Lu'an Hospital of Traditional Chinese Medicine, Lu'an 237006, China.""}, {'ForeName': 'Shifu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Wuhu Hospital of Traditional Chinese Medicine, Wuhu 241000, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5057894']
1451,33101692,Effects of a single mental chronometry training session in subacute stroke patients - a randomized controlled trial.,"Background


Motor imagery training might be helpful in stroke rehabilitation. This study explored if a single session of motor imagery (MI) training induces performance changes in mental chronometry (MC), motor execution, or changes of motor excitability.
Methods


Subacute stroke patients ( n  = 33) participated in two training sessions. The order was randomized. One training consisted of a mental chronometry task, the other training was a hand identification task, each lasting 30 min. Before and after the training session, the Box and Block Test (BBT) was fully executed and also performed as a mental version which served as a measure of MC. A subgroup analysis based on the presence of sensory deficits was performed. Patients were allocated to three groups (no sensory deficits, moderate sensory deficits, severe sensory deficits). Motor excitability was measured by transcranial magnetic stimulation (TMS) pre and post training. Amplitudes of motor evoked potentials at rest and during pre-innervation as well as the duration of cortical silent period were measured in the affected and the non-affected hand.
Results


Pre-post differences of MC showed an improved MC after the MI training, whereas MC was worse after the hand identification training. Motor execution of the BBT was significantly improved after mental chronometry training but not after hand identification task training. Patients with severe sensory deficits performed significantly inferior in BBT execution and MC abilities prior to the training session compared to patients without sensory deficits or with moderate sensory deficits. However, pre-post differences of MC were similar in the 3 groups. TMS results were not different between pre and post training but showed significant differences between affected and unaffected side.
Conclusion


Even a single training session can modulate MC abilities and BBT motor execution in a task-specific way. Severe sensory deficits are associated with poorer motor performance and poorer MC ability, but do not have a negative impact on training-associated changes of mental chronometry. Studies with longer treatment periods should explore if the observed changes can further be expanded.
Trial registration


DRKS, DRKS00020355, registered March 9th, 2020, retrospectively registered.",2020,Patients with severe sensory deficits performed significantly inferior in BBT execution and MC abilities prior to the training session compared to patients without sensory deficits or with moderate sensory deficits.,"['subacute stroke patients ', 'Subacute stroke patients ( n \u2009=\u200933']","['\n\n\nMotor imagery training', 'transcranial magnetic stimulation (TMS) pre and post training', 'motor imagery (MI) training', 'single mental chronometry training session']","['Severe sensory deficits', 'MC abilities and BBT motor execution', 'TMS results', 'Motor excitability', 'mental chronometry (MC), motor execution, or changes of motor excitability', 'BBT execution and MC abilities', 'Motor execution of the BBT', 'duration of cortical silent period']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}]",,0.0654039,Patients with severe sensory deficits performed significantly inferior in BBT execution and MC abilities prior to the training session compared to patients without sensory deficits or with moderate sensory deficits.,"[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Liepert', 'Affiliation': 'Department of Neurorehabilitation, Kliniken Schmieder, Zum Tafelholz 8, 78476 Allensbach, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Stürner', 'Affiliation': 'Department of Neurorehabilitation, Kliniken Schmieder, Zum Tafelholz 8, 78476 Allensbach, Germany.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Büsching', 'Affiliation': 'Rehaklinik Bellikon, Bellikon, Switzerland.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Sehle', 'Affiliation': 'Department of Neurorehabilitation, Kliniken Schmieder, Zum Tafelholz 8, 78476 Allensbach, Germany.'}, {'ForeName': 'Mircea A', 'Initials': 'MA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Neurorehabilitation, Kliniken Schmieder, Heidelberg, Germany.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00212-w']
1452,33101758,Oral Carbohydrate Administration in Patients Undergoing Cephalomedullary Nailing for Proximal Femur Fractures: An Analysis of Clinical Outcomes and Patient Satisfaction.,"Purpose


The purpose of this study was to investigate the clinical effects of oral carbohydrate intake for cephalomedullary nailing on proximal femoral fractures and patient satisfaction.
Subjects and Methods


88 patients were admitted to our hospital with proximal femoral fracture from July 2019 to December 2019. All patients were treated with closed reduction and internal fixation (CR&IF, Cephalomedullary nailing) under spinal anesthesia. The exclusion criteria included the presence of endocrine disorders including diabetes mellitus (DM), patients treated with steroids, and cognitive impairment. Additionally, those with fasting blood glucose levels above 126 mg / dl or HbA1C> 6.5% were considered as having undiagnosed DM. After obtaining informed consent, the subjects were randomized into either the preoperative oral carbohydrate (POC) group or control group. Patients who were assembled into the control group fasted including water from midnight of the day of the surgical procedure according to the conventional method. Patients assembled into the POC group received 400 ml of oral carbohydrate solution (Nucare NONPO, DAESANG, 12.8%, 1 kcal/ml)) between 21-24 hours on the day before operation and 400 ml oral carbohydrate solution 2 hours before the administration of anesthesia. Serum glucose on the day before operation at 7 am (before breakfast, baseline), immediately before anesthesia, at skin incision, 1 hour, 4 hours, 6 hours, 24 hours after anesthesia, and 3 days after surgery (before breakfast) was measured, and insulin, cortisol, and IL-6 were measured at baseline 7 am at day before operation, immediately before anesthesia, 4 hours and 24 hours after anesthesia, and 3 days after surgery (before breakfast). The patients completed questionnaires about their satisfaction (thirst, hunger, nausea and vomiting, and anxiety) in the morning (before the surgery) on the day of the surgery. Additionally, the length of hospital stay (LOS) and preoperative opioid usage was also investigated.
Results


The operative characteristics of the patients did not differ between the groups except for the actual fasting time. The glucose levels were higher in the control group at skin incision; however, there were no significant differences in both groups at other time points. Additionally, insulin, insulin resistance, cortisol, and IL-6 also did not differ significantly between the 2 groups at all time-points. Among the factors related to patient satisfaction, the POC group showed significantly higher scores for thirst and hunger factors and shorter LOS than the control group.
Conclusion


The intake of oral carbohydrates in patients treated with closed reduction and internal fixation for proximal femoral fractures does not affect the improvement of post-operative insulin resistance. However, there was significant improvement in patients' thirst and hunger before surgery and LOS.",2020,"The glucose levels were higher in the control group at skin incision; however, there were no significant differences in both groups at other time points.","['endocrine disorders including diabetes mellitus (DM), patients treated with steroids, and cognitive impairment', 'Patients Undergoing Cephalomedullary Nailing for Proximal Femur Fractures', 'patients treated with closed reduction and internal fixation for proximal femoral fractures', 'Patients who were assembled into the control group fasted including water from midnight of the day of the surgical procedure according to the conventional method', 'Subjects and Methods\n\n\n88 patients were admitted to our hospital with proximal femoral fracture from July 2019 to December 2019']","['cephalomedullary nailing', 'preoperative oral carbohydrate (POC) group or control group', 'closed reduction and internal fixation (CR&IF, Cephalomedullary nailing) under spinal anesthesia', 'Oral Carbohydrate Administration', 'oral carbohydrate intake', '400 ml of oral carbohydrate solution (Nucare NONPO']","['Serum glucose', 'actual fasting time', 'glucose levels', 'thirst and hunger factors and shorter LOS', 'insulin, insulin resistance, cortisol, and IL-6', 'length of hospital stay (LOS) and preoperative opioid usage', 'fasting blood glucose levels', 'operative characteristics', 'satisfaction (thirst, hunger, nausea and vomiting, and anxiety', 'insulin, cortisol, and IL-6']","[{'cui': 'C0014130', 'cui_str': 'Disorder of endocrine system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332172', 'cui_str': 'Midnight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",88.0,0.0172161,"The glucose levels were higher in the control group at skin incision; however, there were no significant differences in both groups at other time points.","[{'ForeName': 'Suc-Hyun', 'Initials': 'SH', 'LastName': 'Kweon', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Wonkwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Jin Sung', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Republic of Korea Army, Damyang, Korea.'}, {'ForeName': 'Yeong Chang', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Wonkwang University Hospital, Iksan, Korea.'}]",Geriatric orthopaedic surgery & rehabilitation,['10.1177/2151459320958609']
1453,33101762,Tremor Research Group Essential Tremor Rating Scale (TETRAS): Assessing Impact of Different Item Instructions and Procedures.,"Introduction


The Tremor Research Group Essential Tremor Rating Scale (TETRAS) is a well-validated instrument to assess essential tremor. However, similar to all other tremor rating scales, specific instructions for individual tasks are based mostly on expert opinion and tradition. Several tasks have multiple possible variations that have never been compared to determine if they impact score.
Methods


Using blinded, randomized videotapes, a group of tremor experts evaluated multiple ET patients to determine: 1. whether assessments of spirals and writing samples are similar if the rater only sees the end result as opposed to actually watching the task, 2. whether arm tremor ratings (postural and wing-beating) are similar if the subjects hold both hands out concurrently vs. if they only hold one arm out at a time, 3. whether heal to shin tremor scores vary between supine and sitting, and 4. compared cursive vs script writing samples.
Results


Intraclass correlation coefficients (ICC) were excellent (>0.95) for all arm assessments. Writing tremor was rated worse if only rating the spiral/writing photos (p < 0.05) rather than also viewing the writing process, arm tremor scores were higher if each arm was rated individually (p < 0.001), heal to shin scores were higher when done sitting (p = 0.01), and cursive writing tended to be rated higher than script (p = 0.08).
Discussion


Minor procedure differences when administering the TETRAS can significantly alter results.",2020,"Writing tremor was rated worse if only rating the spiral/writing photos (p < 0.05) rather than also viewing the writing process, arm tremor scores were higher if each arm was rated individually (p < 0.001), heal to shin scores were higher when done sitting (p = 0.01), and cursive writing tended to be rated higher than script (p = 0.08).
",[],[],"['heal to shin scores', 'writing process, arm tremor scores', 'cursive writing', 'Writing tremor', 'Tremor Rating Scale (TETRAS']",[],[],"[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0230444', 'cui_str': 'Shin structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270736', 'cui_str': 'Essential tremor'}]",,0.0340341,"Writing tremor was rated worse if only rating the spiral/writing photos (p < 0.05) rather than also viewing the writing process, arm tremor scores were higher if each arm was rated individually (p < 0.001), heal to shin scores were higher when done sitting (p = 0.01), and cursive writing tended to be rated higher than script (p = 0.08).
","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Ondo', 'Affiliation': 'Methodist Neurological Institute, Houston, TX, US.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Pascual', 'Affiliation': 'Methodist Neurological Institute, Houston, TX, US.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Tremor and other hyperkinetic movements (New York, N.Y.)",['10.5334/tohm.64']
1454,33101889,Change in Domain-specific but not General Psychological Flexibility Relates to Greater Weight Loss in Acceptance-Based Behavioral Treatment for Obesity.,"Acceptance-based approaches have demonstrated promise for improving outcomes in behavioral treatments for obesity, but few studies have examined processes of change in these treatments. It is critical to identify mechanisms of action in treatment to further optimize this approach, refine theory, and inform future research. This study examined change in several domain-specific and general measures of psychological flexibility in a randomized controlled trial of an acceptance-based behavioral weight loss treatment. The relationships between change in these measures and weight loss outcomes were also examined. Adults ( N  = 283) were randomized to receive 12 months of acceptance-based (ABT) or non-acceptance-based (non-ABT) behavioral treatment and completed measures of general and weight control-specific psychological flexibility at months 0, 6, and 12. Participants in ABT demonstrated greater increases in psychological flexibility related to eating and physical activity experiences during treatment compared to participants in non-ABT, and changes in these processes were correlated with better weight loss. Parallel mediation analyses further revealed that psychological flexibility related to eating and physical activity experiences partially mediated the relationship between treatment condition and 12-month weight loss. Participants across conditions also experienced small increases in general psychological flexibility, but general psychological flexibility was not meaningfully related to weight loss outcomes. These findings indicate that domain-specific (versus general) psychological flexibility may be most impacted by ABT and most relevant to weight loss outcomes. Results also provide partial support for the theoretical model of ABT for weight management.",2019,"Participants in ABT demonstrated greater increases in psychological flexibility related to eating and physical activity experiences during treatment compared to participants in non-ABT, and changes in these processes were correlated with better weight loss.",['Adults ( N  = 283'],"['acceptance-based behavioral weight loss treatment', 'acceptance-based (ABT) or non-acceptance-based (non-ABT) behavioral treatment and completed measures of general and weight control-specific psychological flexibility']","['weight loss outcomes', 'general psychological flexibility', 'psychological flexibility related to eating and physical activity experiences', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",283.0,0.0202639,"Participants in ABT demonstrated greater increases in psychological flexibility related to eating and physical activity experiences during treatment compared to participants in non-ABT, and changes in these processes were correlated with better weight loss.","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Schumacher', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA.'}]",Journal of contextual behavioral science,['10.1016/j.jcbs.2019.01.008']
1455,33102224,Sequence Inversion to Facilitate Concurrent Radiotherapy and Systemic Therapy. A Proof of Principle Study in the Setting of a Phase II Randomized Trial in Prostate Cancer.,"Background:  Concomitant chemo-radiation for pelvic cancers remains challenging to be delivered at full doses. We hypothesized that fewer delays in chemotherapy would occur if the sequence of radiotherapy would be reversed, starting with the boost volume followed by the elective nodal volume. We report the result of a Phase II randomized study for high risk prostate cancer.  Patients and Method:  The study was a double-blinded phase II randomized trial. Patients were eligible if they had non-metastatic high-risk prostate cancer. All patients received 2.5 years of hormonal therapy and 46.5 Gy in 25 fractions to the pelvic lymph nodes. Patients received a radiation boost to the prostate, either before or after whole pelvic irradiation. Concurrent (20 mg/m 2 ) Docetaxel was given on the first day of radiotherapy and weekly thereafter for a total of eight treatments until predefined toxicity stopping rules.  Results:  Ninety patients were included and randomized. Four were ineligible for the analysis. In total, 42 patients were randomized to the standard sequence, 44 patients to the experimental sequence. There were statistically fewer GI or GU toxicities leading to a docetaxel dose reduction or omission in the experimental sequence compared to the standard sequence, 5 vs. 15 events ( p  = 0.027). There was no difference in overall survival, cause-specific survival, or biochemical-relapse free survival between the two sequences.  Conclusions:  This is the first study to test sequence inversion for pelvic radio-chemotherapy in a randomized double-blind trial. Less chemotherapy interruptions or dose reductions occurred by inverting the radiation sequence of the large field and the boost. The trial was registered with Clinicaltrials.gov: NCT00452556.",2020,"There was no difference in overall survival, cause-specific survival, or biochemical-relapse free survival between the two sequences.  ","['42 patients were randomized to the standard sequence, 44 patients to the experimental sequence', 'Patients were eligible if they had non-metastatic high-risk prostate cancer', 'high risk prostate cancer', 'Ninety patients were included and randomized']","['hormonal therapy', 'pelvic radio-chemotherapy', 'Docetaxel', ':  Concomitant chemo-radiation', 'docetaxel']","['overall survival, cause-specific survival, or biochemical-relapse free survival', 'GI or GU toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",90.0,0.0982445,"There was no difference in overall survival, cause-specific survival, or biochemical-relapse free survival between the two sequences.  ","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wilke', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Slawa', 'Initials': 'S', 'LastName': 'Cwajna', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rutledge', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hollenhorst', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bowes', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Nikhilesh', 'Initials': 'N', 'LastName': 'Patil', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Casely T', 'Initials': 'CT', 'LastName': 'Ago', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Pignol', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, NS, Canada.'}]",Frontiers in oncology,['10.3389/fonc.2020.570660']
1456,33102286,Effect of psychoeducation on short-term outcome in patients with late life depression: A randomized control trial - Protocol.,"Background


This is the PhD thesis protocol of an ongoing study entitled 'Effect of Psychoeducation on short- term outcome in patients with Late Life Depression: A Randomized Control Trial'. Psychoeducation is a proof-based therapeutic intervention for patients and their caretakers/family members that provides plenty of information and support for better understanding and coping up with the illness, which is being diagnosed.
Aim


The aim is to examine the effect of psychoeducation on short- term outcome in patients with late life depression.
Hypothesis


The hypothesis is that psychoeducation will improve outcome in patients with late life depression at 4 weeks. The sample size is 154.
Material and Methods


The methodology is that patients aged 60 years and above coming to Out Patient Department (OPD) of the Department of Geriatric Mental Health, King George's Medical University and having the first episode of depression, which has been clinically diagnosed, will be taken. Then, Mini International Neuropsychiatric Interview (MINI) 6.0.0 will be applied for the confirmation of diagnosis. After confirmation, Hindi Mental Status Examination (HMSE) will be done to know the cognitive status, those scoring 24 and above on HMSE will be included in the study. The included patients will be evaluated on Hamilton Depression Rating Scale (HAM-D), Geriatric Depression Scale (GDS) and Knowledge Attitude Experience (KAE) Questionnaire. Next, the patients will be randomized in case group and control group. Case group will be given intervention of 'psychoeducation' through a video, and control group will be given 'placebo' through a video. For both the groups, the first follow up termed as 'booster session' will be at 2 weeks +/- 4 days from the baseline and second follow up will be at 4 weeks +/- 4 days from the baseline.
Statistical Analysis


Data will be recorded on the spreadsheet and the results will be analyzed using the statistical software.",2020,"For both the groups, the first follow up termed as 'booster session' will be at 2 weeks +/-","['patients with late life depression', ""patients aged 60 years and above coming to Out Patient Department (OPD) of the Department of Geriatric Mental Health, King George's Medical University and having the first episode of depression"", 'patients with Late Life Depression', 'patients with late life depression at 4 weeks', 'patients and their caretakers/family members']","['Psychoeducation', 'psychoeducation']","['Hamilton Depression Rating Scale (HAM-D), Geriatric Depression Scale (GDS) and Knowledge Attitude Experience (KAE) Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0711162,"For both the groups, the first follow up termed as 'booster session' will be at 2 weeks +/-","[{'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ""Department of Geriatric Mental Health, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': ""Department of Geriatric Mental Health, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""Department of Geriatric Mental Health, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_311_20']
1457,33102291,The effectiveness of training program based on protective motivation theory on improving nutritional behaviors and physical activity in military patients with type 2 diabetes mellitus.,"Introduction


Diabetes is considered as one of the most common metabolic disorders and one of the biggest worldwide health problems; first-line treatment is suggested as a changing diet and physical activity by experts. The aim of the present study was the determination of the effectiveness of a training program based on a protective motivation theory on improving nutritional behaviors and physical activity in type 2 military diabetic patients.
Methods


In this controlled intervention study, 76 military diabetic individuals (2 groups with 38 individuals in each) were participated. Data gathering instrument was a researcher-made questionnaire based on structures of conservation motivation theory. The data were entered into SPSS19 software and analyzed by using paired  t -test and Pearson's correlation coefficient.
Results


Findings showed that except in perceived sensitivity in the test and control groups, there was a significant difference between the mean scores of all the components of the Protective Motivation Theory. In the test group, there was a significant difference between the mean scores of all constructs of the Protective Motivation Theory before and after the educational intervention, while in the control group, there was a significant difference between the mean scores of fear, effectiveness of response, severity, and perceived sensitivity structures before and after educational intervention. Glycated hemoglobin (Hb-A1c) and weight of the intervention group were significantly decreased after the intervention. In addition, adherence to diet and physical activity were increased.
Conclusion


The results of this study showed that conservation motivation theory can be used as a framework in designing educational programs to improve the diet and physical activity among diabetics.",2020,"In the test group, there was a significant difference between the mean scores of all constructs of the Protective Motivation Theory before and after the educational intervention, while in the control group, there was a significant difference between the mean scores of fear, effectiveness of response, severity, and perceived sensitivity structures before and after educational intervention.","['military patients with type 2 diabetes mellitus', '76 military diabetic individuals (2 groups with 38 individuals in each) were participated', 'type 2 military diabetic patients']","['training program based on protective motivation theory', 'training program based on a protective motivation theory']","['nutritional behaviors and physical activity', 'mean scores of fear, effectiveness of response, severity, and perceived sensitivity structures', 'adherence to diet and physical activity', 'Glycated hemoglobin (Hb-A1c) and weight', 'perceived sensitivity', 'Protective Motivation Theory']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",76.0,0.0133248,"In the test group, there was a significant difference between the mean scores of all constructs of the Protective Motivation Theory before and after the educational intervention, while in the control group, there was a significant difference between the mean scores of fear, effectiveness of response, severity, and perceived sensitivity structures before and after educational intervention.","[{'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Dashti', 'Affiliation': 'Researcher, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Dabaghi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Tofangchiha', 'Affiliation': 'AJA Cancer Epidemiology Research and Treatment Center (AJA-CERTC), AJA University of Medical Sciences, Tehran, Iran.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_70_20']
1458,33102316,Postendodontic pain in asymptomatic necrotic teeth prepared with different rotary instrumentation techniques.,"Objectives


to investigate the postendodontic pain in asymptomatic necrotic teeth prepared with different rotary instrumentation techniques after single-visit root canal treatment.
Materials and Methods


A total of 60 single-rooted teeth with single root canal were treated endodontically. Teeth were divided randomly into four equaled groups ( n  = 15) according to instrumentation systems as follows: group I were shaped using ProTaper Universal (control group) (Dentsply/Maillefer, Ballaigues), group 2 were shaped with 2Shape (Micro-Mega) till TS2 (25.06), group 3 were shaped with XP-endo Shaper file (FKG Dentaire) till #30.04, and group 4 were shaped with Reciproc blue (VDW) till R25 (25.08). All groups were prepared according to manufacturer's instructions and obturated with lateral condensation technique. Pain levels were assessed by visual analog scale (VAS) and verbal evaluation of pain questionnaire after 6, 12, 24, 48 h, and 7 days of canal obturation. Data were then analyzed using Kruskal-Wallis and Mann-Whitney U tests at  P  value of 0.05.
Results


Postendodontic pain started after 6 h of treatment with highest values and then decreased gradually until almost vanished after 1 week of treatment, with no significant differences in VAS among studied groups (ProTaper, 2 shape, XP endo Shaper, and Reciproc Blue) after 6,12, and 48 h of treatment. On the other hand, XP endo Shaper group, showed the lowest pain values after 24 h of treatment, and the highest pain values were found in 2 shape group after 1 week with significance ( P  < 0.05).
Conclusion


Root canals prepared with XP endo Shaper resulted in the lowest pain levels after 24 h of treatment. Root canal preparation with 2Sshape rotary system resulted in the highest pain levels after 1 week of treatment.",2020,Root canal preparation with 2Sshape rotary system resulted in the highest pain levels after 1 week of treatment.,['A total of 60 single-rooted teeth with single root canal were treated endodontically'],"['ProTaper Universal (control group) (Dentsply/Maillefer, Ballaigues), group 2 were shaped with 2Shape (Micro-Mega) till TS2', '2Sshape rotary system']","['lowest pain values', 'Postendodontic pain', 'highest pain levels', 'Pain levels', 'visual analog scale (VAS) and verbal evaluation of pain questionnaire', 'lowest pain levels', 'highest pain values', 'Postendodontic pain started']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",60.0,0.0293298,Root canal preparation with 2Sshape rotary system resulted in the highest pain levels after 1 week of treatment.,"[{'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Al-Nahlawi', 'Affiliation': 'Department of Endodontics and Operative Dentistry, Syrian Private University, Damascus, Syria.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alabdullah', 'Affiliation': 'Department of Endodontics and Operative Dentistry, Syrian Private University, Damascus, Syria.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Othman', 'Affiliation': 'Department of Endodontics and Operative Dentistry, Syrian Private University, Damascus, Syria.'}, {'ForeName': 'Raghad', 'Initials': 'R', 'LastName': 'Sukkar', 'Affiliation': 'Department of Endodontics and Operative Dentistry, Syrian Private University, Damascus, Syria.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Doumani', 'Affiliation': 'Department of Restorative Dental Sciences, Alfarabi Colleges of Dentistry and Nursing, Riyadh, Saudi Arabia.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_342_20']
1459,33102330,"Effectiveness of various health education methods amongst primary healthcare workers of western Uttar Pradesh, Delhi (National Capital Region), India: A promotive intervention study.","Objectives


The purpose of this study was to assess the effectiveness of various health education methods for improving oral health knowledge of accredited social health activists (ASHA) and  Anganwadi  workers of Muradnagar Block, Ghaziabad-Delhi NCR.
Methods


A promotive interventional study was conducted amongst 301 ASHA and  Anganwadi  workers of Muradnagar block at three steps such as baseline, oral health education programme (OHEP), and reinforcement to assess their oral health knowledge using predesigned, close-ended, validated, questionnaire. Four different methods were used in OHEP to disseminate knowledge, namely, health talks, posters, and pamphlets, PowerPoint presentations, and a combination of all methods. Post-assessment was done one week after OHEP followed by reinforcement after 1 month which was followed by final post-assessment after 1 week. Students' independent  t -test and one-way ANOVA were used for analysing data.
Results


At baseline, primary healthcare workers had mean knowledge scores as 14.67 ± 1.152 which was increased to 20.96 ± 1.053 after the intervention and 27.6 ± 0.762 after reinforcement. There was an increase of 7.6% and 14.3% of primary healthcare workers giving correct responses after OHEP and reinforcement, respectively.
Conclusions


The combination method was the most effective in improving oral health knowledge of study population followed by posters and pamphlets and the least effective method was PowerPoint presentation. Dentists can play a vital role in mobilising the primary healthcare workers by consequently contributing towards improving the oral health status of the community.",2020,The combination method was the most effective in improving oral health knowledge of study population followed by posters and pamphlets and the least effective method was PowerPoint presentation.,"['301 ASHA and  Anganwadi  workers of Muradnagar block at three steps such as baseline, oral health education programme (OHEP), and reinforcement to assess their oral health knowledge using predesigned, close-ended, validated, questionnaire', 'primary healthcare workers of western Uttar Pradesh, Delhi (National Capital Region), India']",['various health education methods'],"['oral health knowledge', 'mean knowledge scores']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0577186,The combination method was the most effective in improving oral health knowledge of study population followed by posters and pamphlets and the least effective method was PowerPoint presentation.,"[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Bhagia', 'Affiliation': 'Department of Public Health Dentistry, ITS - CDSR, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Ipseeta', 'Initials': 'I', 'LastName': 'Menon', 'Affiliation': 'Department of Public Health Dentistry, ITS - CDSR, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Ricky Pal', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Department of Land and Food Systems, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Public Health Dentistry, ITS - CDSR, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Goyal', 'Affiliation': 'Research Department, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India.'}, {'ForeName': 'Dipshikha', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': 'Department of Public Health Dentistry, ITS - CDSR, Ghaziabad, Uttar Pradesh, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_143_20']
1460,33102346,Maternal health-related barriers and the potentials of mobile health technologies: Qualitative findings from a pilot randomized controlled trial in rural Southwestern Uganda.,"Background


Maternal mortality rate remains unacceptably high in Uganda. In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking. The potentials of mobile health technologies in addressing the maternal health challenges remain unclear.
Aim


To explore the maternal health-related barriers among illiterate pregnant women in rural Southwestern Uganda and highlight the potentials of mobile health technologies.
Material and Methods


This is a midline qualitative study conducted with the participants of a pilot randomized controlled trial. Between October 2019 and December 2019, we carried out semi-structured interviews with 30 illiterate pregnant mothers. Interviews elicited information on the barriers to access and utilization of maternal health services. An inductive, content analytic approach was used to analyze qualitative data. Quantitative sociodemographic and socioeconomic data were summarized descriptively.
Results


Participants reported that lack of money (for transport and medical costs), unfriendly maternal health services, and delays at the maternal health clinic constrain access and utilization of maternal health services. Given their widespread adoption, mobile technologies can potentially address some of these barriers e.g., money for transport or microenterprise start-up can be sent to women through their mobile phones or maternal health-related services (such as health education and consultation) can be provided electronically.
Conclusion


Future efforts should focus on utilizing mobile health technologies to not only enable women overcome the critical financial challenges but also facilitate remote access and utilization of maternal health services.",2020,In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking.,"['rural illiterate pregnant women', 'illiterate pregnant women in rural Southwestern Uganda', 'rural Southwestern Uganda', 'Between October 2019 and December 2019, we carried out semi-structured interviews with 30 illiterate pregnant mothers']",[],"['lack of money (for transport and medical costs), unfriendly maternal health services, and delays at the maternal health clinic constrain access and utilization of maternal health services']","[{'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",[],"[{'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0024922', 'cui_str': 'Health Services, Maternal'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0762542,In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking.,"[{'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Tumuhimbise', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Esther C', 'Initials': 'EC', 'LastName': 'Atukunda', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Sandrah', 'Initials': 'S', 'LastName': 'Ayebaza', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Katusiime', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Mugyenyi', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Pinkwart', 'Affiliation': 'Humbold t-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Angella', 'Initials': 'A', 'LastName': 'Musiimenta', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_281_20']
1461,33102380,A Comparative Study on the Efficacy of Levetiracetam and Carbamazepine in the Treatment of Rolandic Seizures in Children: An Open-Label Randomized Controlled Trial.,"Objective


This study was performed to investigate whether levetiracetam should be preferred to carbamazepine as a treatment choice for benign childhood epilepsy with centro Temporal spikes (BCECTS), the most common partial epilepsy of childhood.
Methods


This randomized clinical trial study included 92 children with rolandic epilepsy aged 4-12 years referred to the Pediatric Neurology Clinic at Imam Hossein Hospital, Isfahan, Iran, from April 2019 to January 2020. Patients were selected consecutively and randomly assigned to two study groups (levetiracetam and carbamazepine groups). Patients were followed and revisited every 2 months for 6 months after starting the medication. The frequency and duration of seizure attacks and drug side effects were recorded before treatment and in bi-monthly visits. Data were analyzed by SPSS software Version 24 using Mann-Whitney U- test and Friedman test.
Findings


In our study, the seizure frequency decrease was not significantly different between the two groups; however, patients in both groups showed significantly lower seizure frequency in 2, 4, and 6 months of follow-up compared to starting time. After a follow-up for 6 months, one out of 47 (2.1%) patients using levetiracetam showed intolerance, resulting in changing the medication. In addition, two out of 48 (4.1%) patients in the carbamazepine group had skin rashes. No significant changes had been reported regarding the duration of seizure attacks in both groups after treatment.
Conclusion


This study showed encouraging results for using levetiracetam, with acceptable results and fewer side effects for the treatment of children with BCECTS in Iran.",2020,"No significant changes had been reported regarding the duration of seizure attacks in both groups after treatment.
","['children with BCECTS in Iran', 'Rolandic Seizures in Children', '92 children with rolandic epilepsy aged 4-12 years referred to the Pediatric Neurology Clinic at Imam Hossein Hospital, Isfahan, Iran, from April 2019 to January 2020']","['levetiracetam', 'Levetiracetam and Carbamazepine', 'levetiracetam and carbamazepine', 'carbamazepine']","['skin rashes', 'seizure frequency', 'duration of seizure attacks', 'side effects', 'frequency and duration of seizure attacks and drug side effects', 'seizure frequency decrease']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2363129', 'cui_str': 'Benign Rolandic epilepsy'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0376532', 'cui_str': 'Rolands Epilepsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715202', 'cui_str': 'Child and adolescent neurology clinic'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0730597', 'cui_str': 'Duration of seizure'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",92.0,0.0468686,"No significant changes had been reported regarding the duration of seizure attacks in both groups after treatment.
","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Ahadi', 'Affiliation': 'Department of Pediatrics, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Nasiri', 'Affiliation': 'Child Growth and Developmental Research Center, Research Institute for Primordial Prevention of Noncommunicable Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ghazavi', 'Affiliation': 'Child Growth and Developmental Research Center, Research Institute for Primordial Prevention of Noncommunicable Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Toktam', 'Initials': 'T', 'LastName': 'Mosavian', 'Affiliation': 'Department of Pediatrics, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mansouri', 'Affiliation': 'Child Growth and Developmental Research Center, Research Institute for Primordial Prevention of Noncommunicable Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in pharmacy practice,['10.4103/jrpp.JRPP_20_53']
1462,33102383,"The Effect of Octreotide in Acute Nonvariceal Upper Gastrointestinal Bleeding: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objective


Nonvariceal upper gastrointestinal bleeding (NUGIB) is a common cause of hospitalization and is associated with considerable mortality and morbidity. Octreotide has been shown to be an effective treatment in the control of variceal UGIB. Theoretically, octreotide could be effective in the treatment of other types of bleeding ulcers.
Methods


This randomized, double-blind, placebo-controlled trial was carried out on patients with NVUGIB who had been admitted to two referral centers in Shiraz, Iran. Patients were randomized to two groups: Group A ( n  = 58) received octreotide and Group B ( n  = 58) received a placebo. Patients in both groups received pantoprazole 40 mg as an initial dose, then 40 mg every 12 h intravenously. In addition to the pantoprazole, patients in Group A received 100 μg octreotide subcutaneously every 8 h for 72 h or until they were discharged. Patients in Group B received pantoprazole and a placebo at the same dose schedule.
Findings


There were no statistically significant differences between Groups A and B in terms of mortality (0 vs. 5.17%;  P  = 0.21,) rebleeding rate (5.17% vs. 1.72%;  P  = 0.5), blood transfusion requirement (1.65 ± 0.47 units vs. 1.70 ± 0.45 units;  P  = 0.45), length of hospital stay (1.96 ± 1.00 days vs. 1.65 ± 0.84 days;  P  = 0.44), and need for surgery (1.72% vs. 1.72%;  P  = 0.7).
Conclusion


The results showed that use of subcutaneous octreotide as an adjuvant treatment did not have a beneficial effect on the treatment of NVUGIB.",2020,"There were no statistically significant differences between Groups A and B in terms of mortality (0 vs. 5.17%;  P  = 0.21,) rebleeding rate (5.17% vs. 1.72%;  P  = 0.5), blood transfusion requirement (1.65 ± 0.47 units vs. 1.70 ± 0.45 units;  P  = 0.45), length of hospital stay (1.96 ± 1.00 days vs. 1.65 ± 0.84 days;  P  = 0.44), and need for surgery (1.72% vs. 1.72%;  P  = 0.7).
","['patients with NVUGIB who had been admitted to two referral centers in Shiraz, Iran', 'Acute Nonvariceal Upper Gastrointestinal Bleeding']","['Octreotide', 'pantoprazole', 'subcutaneous octreotide', 'placebo', 'octreotide', 'Placebo']","['rebleeding rate', 'length of hospital stay', 'mortality', 'blood transfusion requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.588597,"There were no statistically significant differences between Groups A and B in terms of mortality (0 vs. 5.17%;  P  = 0.21,) rebleeding rate (5.17% vs. 1.72%;  P  = 0.5), blood transfusion requirement (1.65 ± 0.47 units vs. 1.70 ± 0.45 units;  P  = 0.45), length of hospital stay (1.96 ± 1.00 days vs. 1.65 ± 0.84 days;  P  = 0.44), and need for surgery (1.72% vs. 1.72%;  P  = 0.7).
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Abrishami', 'Affiliation': 'Health Policy Research Center, Institute of Heath, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Peymani', 'Affiliation': 'Health Policy Research Center, Institute of Heath, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': 'Health Policy Research Center, Institute of Heath, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran B', 'Initials': 'KB', 'LastName': 'Lankarani', 'Affiliation': 'Health Policy Research Center, Institute of Heath, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of research in pharmacy practice,['10.4103/jrpp.JRPP_19_57']
1463,33102384,The Comparison of Levofloxacin- and Clarithromycin-Based Bismuth Quadruple Therapy Regimens in  Helicobacter pylori  Eradication.,"Objective


The aim of the current study was to compare the efficacy of quadruple therapy including levofloxacin and clarithromycin for  Helicobacter pylori  eradication.
Methods


This clinical trial study was conducted on 189 patients with  H. pylori  infection who underwent gastroscopy and stomach biopsy in Shahid Beheshti Hospital, Kashan, Iran. After classification of patients, one group was treated with bismuth subcitrate (120 mg, 2 tablet/12 h), omeprazole (20 mg/12 h), amoxicillin (1 g/12 h), and clarithromycin (500 mg/12 h) and other group with bismuth subcitrate (120 mg, 2 tablet/12 h), omeprazole (20 mg/12h), amoxicillin (1 g/12 h), and levofloxacin (500 mg/12 h) for 2 weeks. After the end of the antibiotic treatment, omeprazole therapy was continued for 4 weeks. Two weeks after discontinuation of omeprazole, fecal antigen test was performed for both the groups to confirm the eradication of  H. pylori  infection.
Findings


The success of  H. pylori  eradication in the levofloxacin and clarithromycin groups was observed in 78 (89.7%) and 71 (69.6%) patients, respectively ( P  < 0.01). A significant difference was also seen between the two groups in terms of side effects and its incidence ( P  < 0.01), so that the incidence of side effect types in the clarithromycin group was more than the levofloxacin group except muscular pain and fatigue ( P  < 0.01).
Conclusion


Levofloxacin-based quadruple regimen therapy was superior to clarithromycin-based quadruple regimens regarding  H. pylori  eradication and side effects. Therefore, the levofloxacin-based regimen can be considered as an effective treatment for the first-line anti- H. pylori  therapy.",2020,"A significant difference was also seen between the two groups in terms of side effects and its incidence ( P  < 0.01), so that the incidence of side effect types in the clarithromycin group was more than the levofloxacin group except muscular pain and fatigue ( P  < 0.01).
","['Helicobacter pylori  Eradication', '189 patients with  H. pylori  infection who underwent gastroscopy and stomach biopsy in Shahid Beheshti Hospital, Kashan, Iran']","['levofloxacin and clarithromycin', 'levofloxacin', 'amoxicillin', 'Levofloxacin- and Clarithromycin-Based Bismuth Quadruple Therapy Regimens', 'clarithromycin', 'omeprazole', 'bismuth subcitrate', 'Levofloxacin']","['success of  H. pylori  eradication', 'side effects and its incidence', 'muscular pain and fatigue']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0192420', 'cui_str': 'Biopsy of stomach'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",189.0,0.0131783,"A significant difference was also seen between the two groups in terms of side effects and its incidence ( P  < 0.01), so that the incidence of side effect types in the clarithromycin group was more than the levofloxacin group except muscular pain and fatigue ( P  < 0.01).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Arj', 'Affiliation': 'Authoimmune Disease Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mollaei', 'Affiliation': 'Authoimmune Disease Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Razavizadeh', 'Affiliation': 'Authoimmune Disease Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moraveji', 'Affiliation': 'Authoimmune Disease Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}]",Journal of research in pharmacy practice,['10.4103/jrpp.JRPP_19_86']
1464,33102395,Prostatic artery embolization versus transurethral resection of the prostate in management of benign prostatic hyperplasia.,"Background


Transurethral resection of the prostate (TURP) is considered the gold standard surgical intervention for prostate size less than 80 g. Prostatic artery embolization (PAE) has been suggested as a minimally invasive interventional radiological procedure in the management of benign prostatic hyperplasia (BPH), especially by using the PErFecTED technique. We aim through our study to evaluate the efficacy and safety of PAE compared with those of monopolar transurethral resection of prostate (M-TURP) and bipolar transurethral resection of prostate (B-TURP) in treating lower urinary tract symptoms (LUTSs) secondary to BPH.
Methods


We randomized 60 patients into 3 equal groups representing M-TURP, B-TURP, and PAE. Patients were followed up at 1 and 6 months postoperatively with regard to the International prostate symptom score (IPSS) score; uroflowmetry; prostate volume by transrectal ultrasound; and postvoid residual urine.
Results


The mean operative time was 59, 68, and 89 minutes for the M-TURP group, the B-TURP group, and the PAE group, respectively; only one patient, who represented 5% of the M-TURP group and 1.7% of the whole study population, developed transurethral resection syndrome. Four patients of the PAE group complained of postembolization syndrome, which represented 20% of the cases. Only two patients in our study, both belonging to the PAE group, developed acute urinary retention after catheter removal, representing 10% of the PAE group and 3.33% of the whole study population. The improvement in the IPSS score, the average uroflowmetry (Q-average) score, postvoid residual urine, and prostate volume reduction was noted in all groups, with more statistically significant improvement in each of the M-TURP and the B-TURP groups than in the PAE group.
Conclusion


PErFecTED technique is a novel way of embolization, with statistically significant improvement for patients complaining of LUTSs due to BPH in terms of improvement of IPSS, uroflowmetry, prostate size, and amount of postvoid residual urine, yet these results are still not comparable with either the results of M-TURP or B-TURP that still show more effective improvement.",2020,"Patients were followed up at 1 and 6 months postoperatively with regard to the International prostate symptom score (IPSS) score; uroflowmetry; prostate volume by transrectal ultrasound; and postvoid residual urine.
","['benign prostatic hyperplasia', '60 patients into 3 equal groups representing M-TURP, B-TURP, and PAE']","['bipolar transurethral resection of prostate (B-TURP', '\n\n\nTransurethral resection of the prostate (TURP', 'Prostatic artery embolization versus transurethral resection', 'PAE', 'monopolar transurethral resection of prostate (M-TURP', 'Prostatic artery embolization (PAE']","['mean operative time', 'acute urinary retention', 'efficacy and safety', 'IPSS score, the average uroflowmetry (Q-average) score, postvoid\xa0residual urine, and prostate volume reduction', 'International prostate symptom score (IPSS) score; uroflowmetry; prostate volume by transrectal ultrasound; and postvoid\xa0residual urine', 'postembolization syndrome', 'transurethral resection syndrome']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0349610', 'cui_str': 'TUR syndrome'}]",60.0,0.0213501,"Patients were followed up at 1 and 6 months postoperatively with regard to the International prostate symptom score (IPSS) score; uroflowmetry; prostate volume by transrectal ultrasound; and postvoid residual urine.
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Radwan', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farouk', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Higazy', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Younan R', 'Initials': 'YR', 'LastName': 'Samir', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Tawfeek', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Gamal', 'Affiliation': 'Ain Shams University Hospitals, Cairo, Egypt.'}]",Prostate international,['10.1016/j.prnil.2020.04.001']
1465,33102386,Effect of Oral Midazolam in Pain Relief of Patients Need Nasogastric Tube Insertion: A Clinical Trial Study.,"Objective


Due to the presence of pain during nasogastric tube (NGT) insertion and related complications and lack of positive clinical response of nasopharyngeal anesthesia with lidocaine and the related side effects and limitations in ketamine and intravenous midazolam, this study aims to determine the efficacy of oral midazolam in relieving pain in the patients requiring NGT insertion.
Methods


A randomized, triple-blind clinical trial was performed on the patients in the Emergency Department of Zanjan Valiasr and Mousavi Hospitals in Iran, who were nominated for NGT. In each group, 100 patients were examined. Two milligram syrups of midazolam and placebo were administered 20 min before the procedure. In two groups, the pain based on the Visual Analog Scale and satisfaction rate of patients during the NGT insertion were compared. The data were analyzed through the SPSS software version 16.0.
Findings


There was no statistically significant difference in the demographic characteristics of two groups. Despite the effects of potential confounding variables, the cause of the referral and indication of NGT, as well as the use of midazolam syrup, had a significant relationship with the outcome, so that midazolam group experienced less pain. The mean and standard deviation of the examined outcomes (feeling of pain and satisfaction with NGT insertion) was statistically significantly different in the midazolam group as compared to the placebo group ( P  = 0.001).
Conclusion


Midazolam was effective in decreasing pain and increasing the satisfaction of patients after NGT insertion. This manuscript is registered in Irct. com with code IRCT20110629006922N4.",2020,"The mean and standard deviation of the examined outcomes (feeling of pain and satisfaction with NGT insertion) was statistically significantly different in the midazolam group as compared to the placebo group ( P  = 0.001).
","['patients requiring NGT insertion', 'patients in the Emergency Department of Zanjan Valiasr and Mousavi Hospitals in Iran, who were nominated for NGT', 'Patients']","['Nasogastric Tube Insertion', 'nasogastric tube (NGT) insertion', 'Oral Midazolam', 'midazolam', 'placebo', 'midazolam and placebo', 'Midazolam', 'ketamine and intravenous midazolam', 'lidocaine']","['pain based on the Visual Analog Scale and satisfaction rate', 'Pain Relief', 'pain', 'relieving pain', 'mean and standard deviation of the examined outcomes (feeling of pain and satisfaction with NGT insertion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}]",100.0,0.151437,"The mean and standard deviation of the examined outcomes (feeling of pain and satisfaction with NGT insertion) was statistically significantly different in the midazolam group as compared to the placebo group ( P  = 0.001).
","[{'ForeName': 'Asghar Jafari', 'Initials': 'AJ', 'LastName': 'Rouhi', 'Affiliation': 'Department of Emergency Medicine, Moosavi Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zeraatchi', 'Affiliation': 'Department of Emergency Medicine, Moosavi Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Department of Emergency Medicine, Sina Hospital, Tabriz University of Medical science, Tabriz, Iran.'}, {'ForeName': 'Asghar Jafari', 'Initials': 'AJ', 'LastName': 'Rouhi', 'Affiliation': 'Department of Clinical Pharmacy (Pharmacotherapy), Drug Applied Research Center, Sina Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Motamed', 'Affiliation': 'Department of Social Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Rastin', 'Affiliation': 'Department of Emergency Medicine, Moosavi Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Karami', 'Affiliation': 'Department of Infectious Disease, Valiasr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Nejabatian', 'Affiliation': 'Department of Emergency Medicine, Moosavi Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}]",Journal of research in pharmacy practice,['10.4103/jrpp.JRPP_19_80']
1466,33102416,Father Involvement in Early Childhood Care: Insights From a MEL System in a Behavior Change Intervention Among Rural Indian Parents.,"Introduction:  Fathers' involvement in care and early initiation of cognitive development activities have a positive impact on a child's social-behavioral, cognitive-academic and emotional-psychological development. This research study, conducted in Tamil Nadu in south India (2017-19), employed a Cluster Randomized Trial to test the impact of techno-social innovations in improving the involvement of fathers in child-care on child development outcomes. Qualitative studies were used to inform the trial and provide insights into pathways of change.  Objective:  This paper discusses the design, implementation and results of the study through the monitoring, evaluation and learning (MEL) framework to provide an understanding of the perceptions among parents and service providers surrounding early child development, the adaptations and learnings through the intervention period, and changes that were brought about through the intervention.  Methods:  The study was at a Proof of Concept stage, and the primary learning objective was to keep the learning process going through the period of the study, as well as obtain evidence to inform future model development. The measurement for change process in the study occurred in three distinct yet interconnected stages. In the first stage, the program was planned, and the design was refined for both the implementation and evaluation of the project. The next stage was the actual implementation: with a learning loop during the execution of the main intervention. The third stage was intended to reflect on the adaptations and pathways to change through the project period and collate evidence for model refinement.  Results and Discussion:  The data collected from the formative research was used to design, develop and implement the intervention. Lessons in coordination with the government program not only brought policy visibility, access to secondary data, and enabled field research, but also provided access to a workforce with immense field knowledge and presence in the rural underserved population. In order to continuously inform the implementation process of the intervention, the feedback loops allowed for adaptions to be made at each stage. The findings provide insights for programming early childhood development interventions, especially interventions regarding improving father's involvement in child-care, and ways to leverage evidence in these interventions.",2020,"In order to continuously inform the implementation process of the intervention, the feedback loops allowed for adaptions to be made at each stage.","['Father Involvement in Early Childhood Care', 'rural underserved population', 'Rural Indian Parents', 'Tamil Nadu in south India (2017-19', 'fathers in child-care on child development outcomes']",[],[],"[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],[],,0.0264503,"In order to continuously inform the implementation process of the intervention, the feedback loops allowed for adaptions to be made at each stage.","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Institute for Financial Management and Research, LEAD at Krea University, Chennai, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Chandramohan', 'Affiliation': 'Emory University Rollins School of Public Health, Atlanta, GA, United States.'}, {'ForeName': 'Nandhini', 'Initials': 'N', 'LastName': 'Sundaravathanam', 'Affiliation': 'Institute for Financial Management and Research, LEAD at Krea University, Chennai, India.'}, {'ForeName': 'Arvind Balaji', 'Initials': 'AB', 'LastName': 'Rajasekaran', 'Affiliation': 'Institute for Financial Management and Research, LEAD at Krea University, Chennai, India.'}, {'ForeName': 'Rathish', 'Initials': 'R', 'LastName': 'Sekhar', 'Affiliation': 'Institute for Financial Management and Research, LEAD at Krea University, Chennai, India.'}]",Frontiers in public health,['10.3389/fpubh.2020.00516']
1467,33102510,Daily Fermented Whey Consumption Alters the Fecal Short-Chain Fatty Acid Profile in Healthy Adults.,"Gut microbiota influences many aspects of host health including immune, metabolic, and gut health. We examined the effect of a fermented whey concentrate (FWC) drink rich in L-(+)-Lactic acid, consumed daily, in 18 healthy men ( n  = 5) and women ( n  = 13) in free-living conditions.  Objective:  The aims of this 6-weeks pilot trial were to (i) identify changes in the gut microbiota composition and fecal short chain fatty acid (SCFA) profile, and (ii) to monitor changes in glucose homeostasis.  Results:  Total fecal SCFA (mM) concentration remained constant throughout the intervention. Proportionally, there was a significant change in the composition of different SCFAs compared to baseline. Acetate levels were significantly reduced (-6.5%;  p  < 0.01), coupled to a significant increase in the relative amounts of propionate (+2.2%;  p  < 0.01) and butyrate (+4.2%;  p  < 0.01), respectively. No changes in the relative abundance of any specific bacteria were detected. No significant changes were observed in glucose homeostasis in response to an oral glucose tolerance test.  Conclusion:  Daily consumption of a fermented whey product led to significant changes in fecal SCFA metabolite profile, indicating some potential prebiotic activity. These changes did not result in any detectable differences in microbiota composition.  Post-hoc  analysis indicated that baseline microbiota composition might be indicative of participants likely to see changes in SCFA levels. However, due to the lack of a control group these findings would need to be verified in a rigorously controlled trial. Future work is also required to identify the biological mechanisms underlying the observed changes in microbiota activity and to explore if these processes can be harnessed to favorably impact host health.  Clinical Trial Registration : www.clinicaltrials.gov, identifier NCT03615339; retrospectively registered on 03/08/2018.",2020,"Acetate levels were significantly reduced (-6.5%;  p  < 0.01), coupled to a significant increase in the relative amounts of propionate (+2.2%;  p  < 0.01) and butyrate (+4.2%;  p  < 0.01), respectively.","['Healthy Adults', '18 healthy men ( n  = 5) and women ( n  = 13) in free-living conditions']","['fermented whey concentrate (FWC) drink rich in L-(+)-Lactic acid', 'Daily Fermented Whey Consumption']","['Total fecal SCFA (mM) concentration', 'relative abundance of any specific bacteria', 'SCFA levels', 'composition of different SCFAs', 'gut microbiota composition and fecal short chain fatty acid (SCFA) profile, and (ii) to monitor changes in glucose homeostasis', 'Acetate levels', 'glucose homeostasis', 'Fecal Short-Chain Fatty Acid Profile', 'fecal SCFA metabolite profile']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",18.0,0.0584123,"Acetate levels were significantly reduced (-6.5%;  p  < 0.01), coupled to a significant increase in the relative amounts of propionate (+2.2%;  p  < 0.01) and butyrate (+4.2%;  p  < 0.01), respectively.","[{'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Smith', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Niamh G', 'Initials': 'NG', 'LastName': 'Maloney', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Shaw', 'Affiliation': 'Centre for Genome Enabled Biology and Medicine, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Graham W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics & Statistics Scotland, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fyfe', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Martin', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Suter', 'Affiliation': 'Bioforce AG, Roggwil, Switzerland.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Scott', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, The Rowett Institute, University of Aberdeen, Aberdeen, United Kingdom.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00165']
1468,33102639,Improving Contrast Enhancement in Pulmonary CTA: The value of breathing maneuvers.,"Purpose


To investigate contrast dynamics and artifacts associated with different breathing maneuvers during pulmonary computed tomography angiography (pCTA) in a prospective randomized clinical trial.
Method


Three different breathing maneuvers (inspiration, expiration, Mueller) were randomly assigned to 146 patients receiving pCTA for suspected pulmonary embolism (PE). Contrast enhancement of central and peripheral arteries and imaging quality of lung parenchyma were compared and analyzed. Results were compared by using the analysis of variances (ANOVA) and Kruskal-Wallis-Test.
Results


Mean enhancement in the pulmonary trunk was highest during breath-hold in inspiration (293 HU, range 195-460 HU) compared to Mueller (259 HU, range 136-429 HU, p = 0022) and expiration (267 HU, range 115-376 HU). This was similar for the right pulmonary artery (inspiration 289 HU, range 173-454 HU; Mueller 250 HU, range 119-378 HU; p = 0.007; expiration 257 HU, range 114-366 HU; p = 0.032) and left pulmonary artery (inspiration 280.3 HU, range 170-462 HU; Mueller 245 HU, range 111-371 HU; p = 0.016; expiration 252 HU, range 110-371 HU).Delineation of peripheral arteries was significantly better in inspiration vs Mueller (p = 0.006) and expiration (p = 0.049). Assessment of the lung parenchyma was significantly better in inspiration vs Mueller (p = 0.013) or expiration (p < 0.001).
Conclusions


Resting inspiratory position achieved the highest enhancement levels in central and peripheral pulmonary arteries and best image quality of the pulmonary parenchyma in comparison to other breathing maneuvers. It is necessary to train the maneuver prior to the examination in order to avoid deep inspiration with the risk of suboptimal opacification of the pulmonary arteries.",2020,"Assessment of the lung parenchyma was significantly better in inspiration vs Mueller (p = 0.013) or expiration (p < 0.001).
",['146 patients receiving'],"['pCTA', 'pulmonary computed tomography angiography (pCTA']","['lung parenchyma', 'central and peripheral arteries and imaging quality of lung parenchyma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0246589,"Assessment of the lung parenchyma was significantly better in inspiration vs Mueller (p = 0.013) or expiration (p < 0.001).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Manava', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galster', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schoen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ficker', 'Affiliation': 'Department of Pulmonology, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Lell', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adamus', 'Affiliation': 'Institute of Radiology, Friedrich-Alexander University, Erlangen-Nuremberg (FAU), Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bruch', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany.'}]",European journal of radiology open,['10.1016/j.ejro.2020.100280']
1469,33102886,Biodex© training post-stroke for postural stability in the upper trunk: A pilot study.,"Background


Stroke affects upper trunk postural stability and upper limb function in approximately 85% of stroke survivors. Upper trunk postural stability is essential for functioning of the upper limb and is a prerequisite for hand function. The rehabilitation of the upper limb and upper trunk post-stroke remains a challenge because of poor recovery of motor and sensory function.
Objectives


To determine the effect of Biodex© upper limb weight-bearing training on upper trunk postural stability in patients post-stroke.
Method


A longitudinal randomised control pilot trial with single blinding was undertaken to assess postural stability on the Biodex© at baseline and 1-month post-baseline. In addition to standard rehabilitative care, upper limb weight-bearing training on the Biodex© was added for participants in the experimental group. Descriptive data analysis and the Mann-Whitney test for group comparisons were done using STATA ( p  < 0.05).
Results


Fifteen participants took part, seven in the control and eight in the experimental group, with an overall median age of 55 years. At baseline there were statistically significant lower scores in the experimental group on overall ( p  = 0.02) and anterior/posterior ( p  = 0.009) stability level 6 (moderately unstable base of support) in the upper trunk postural stability scores. No statistically significant improvements were noted between groups on any of the Biodex© stability levels at 1-month post-baseline testing ( p  > 0.05).
Conclusion


Upper limb weight-bearing training with the addition of Biodex© training did not result in improvements in upper trunk postural stability.
Clinical implications


The findings suggest that exercising on a moderately unstable base of support may improve upper trunk postural stability in patients post-stroke. The addition of Biodex© training to standard rehabilitative care for retraining and exercising upper trunk postural control in a weight-bearing position does not lead to better outcomes than standard care.",2020,"No statistically significant improvements were noted between groups on any of the Biodex© stability levels at 1-month post-baseline testing ( p  > 0.05).
","['patients post-stroke', 'Fifteen participants took part, seven in the control and eight in the experimental group, with an overall median age of 55 years']","['Biodex© upper limb weight-bearing training', 'Biodex© training post-stroke']","['upper trunk postural stability and upper limb function', 'postural stability', 'upper trunk postural stability', 'upper trunk postural stability scores', 'Biodex© stability levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0230093', 'cui_str': 'Upper trunk structure'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0568151,"No statistically significant improvements were noted between groups on any of the Biodex© stability levels at 1-month post-baseline testing ( p  > 0.05).
","[{'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Nel', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Witness', 'Initials': 'W', 'LastName': 'Mudzi', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Elizabeth C Janse', 'Initials': 'ECJ', 'LastName': 'van Vuuren', 'Affiliation': 'Department of Physiotherapy, School of Health and Rehabilitation Sciences, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Eustasius', 'Initials': 'E', 'LastName': 'Musenge', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}]",The South African journal of physiotherapy,['10.4102/sajp.v76i1.1416']
1470,33102889,Two-year results of a double-blind multicenter randomized controlled non-inferiority trial of polyetheretherketone (PEEK) versus silicon nitride spinal fusion cages in patients with symptomatic degenerative lumbar disc disorders.,"Background


During lumbar spinal fusion, spacer cages are implanted to provide vertebral stability, restore sagittal alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used by most spine surgeons. Silicon nitride (Si 3 N 4 ) is a less well-known alternative although it was first used as a spacer in lumbar fusion over 30 years ago. The present study was designed to see if Si 3 N 4  cages would perform similarly to PEEK in a randomized controlled trial.
Methods


A non-inferiority multicenter 100-patient study was designed where both the observer and patient were blinded. Single- or double-level transforaminal lumbar interbody fusion with pedicle screw fixation using an oblique PEEK or Si 3 N 4  cage was performed. The primary non-inferiority outcome was the Roland-Morris Disability Questionnaire (RMDQ). Secondary measures included the Oswestry Disability Questionnaire, Visual Analogue Scales (VAS) for back and leg pain, SF-36 Physical and Mental Function indices, patient and surgeon Likert scores on perceived recovery, and X-ray and CT radiological evaluations for subsidence, segmental motion, and fusion. Follow-up evaluations occurred at 3, 6, 12, and 24 months.
Results


After exclusions for protocol violations and canceled surgeries, 92 patients were randomized (i.e., 48 for PEEK and 44 for Si 3 N 4 ). There were no differences in baseline demographics, pre-operative disabilities, or pain scores between the groups. Both treatment arms showed significant improvements in disability, pain, and recovery scores. No significant differences were observed for subsidence, segmental motion, or fusion. For the primary outcome (i.e., RMDQ scores), the non-inferiority of Si 3 N 4  compared to PEEK could not be established using the original protocol criteria. However, the comparison was undermined by larger than anticipated patient fallout coupled with higher than expected RMDQ score standard deviations. A  post hoc  analysis coupled with a more extensive review of the literature was conducted which resulted in the selection of a revised clinically justified non-inferiority margin; and using this method, the non-inferiority of Si 3 N 4  was affirmed.
Conclusions


This study demonstrated that the use of either PEEK or Si 3 N 4  cages is safe and effective for patients undergoing lumbar spine fusion for chronic degenerative disc disease.",2020,"No significant differences were observed for subsidence, segmental motion, or fusion.","['patients undergoing lumbar spine fusion for chronic degenerative disc disease', 'patients with symptomatic degenerative lumbar disc disorders']","['PEEK or Si 3 N 4  cages', 'silicon nitride spinal fusion cages', 'Single- or double-level transforaminal lumbar interbody fusion with pedicle screw fixation', 'polyetheretherketone (PEEK', 'Polyetheretherketone (PEEK']","['disability, pain, and recovery scores', 'Roland-Morris Disability Questionnaire (RMDQ', 'subsidence, segmental motion, or fusion', 'baseline demographics, pre-operative disabilities, or pain scores', 'Oswestry Disability Questionnaire, Visual Analogue Scales (VAS) for back and leg pain, SF-36 Physical and Mental Function indices, patient and surgeon Likert scores on perceived recovery, and X-ray and CT radiological evaluations for subsidence, segmental motion, and fusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0074525', 'cui_str': 'silicon nitride'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",92.0,0.249313,"No significant differences were observed for subsidence, segmental motion, or fusion.","[{'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McEntire', 'Affiliation': 'SINTX Technologies, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Maslin', 'Affiliation': 'Biomedical Statistical Consulting, Wynnewood, PA, USA.'}, {'ForeName': 'B Sonny', 'Initials': 'BS', 'LastName': 'Bal', 'Affiliation': 'SINTX Technologies, Inc., Salt Lake City, UT, USA.'}]",Journal of spine surgery (Hong Kong),['10.21037/jss-20-588']
1471,33102990,Design and evaluation of a theory-based intervention of knowledge and perceptions to improve self-care amongst relatives of esophageal cancer patients: A randomised controlled trial study protocol.,"Background


Esophageal cancer, as one of the most unknown cancers, is largely preventable through lifestyle modifications. In this study, a theory-based intervention will be designed and evaluated on the knowledge and perceptions of relatives of patients with cancer to improve their self-care.
Methods


This research will be carried out in two phases in Golestan province, located in north of Iran. A researcher-made questionnaire will be designed based on the extended parallel process model using a detailed literature review and the panel of experts' opinions. This questionnaire will aim to investigate the levels of knowledge, perception, and practice of respondents regarding esophageal cancer. Later, a comprehensive program will be designed over esophageal cancer self-care based on the information collected from the questionnaire, the information obtained from detailed literature review, and the experts' opinions. The second phase of the study will include implementation of an educational intervention with pretest-posttest design using the intervention and control groups to measure the effectiveness of this educational program on the knowledge, perception, and practice of the patients' relatives.
Discussion


The findings will provide valuable evidences regarding the efficacy of the educational intervention and will help the participants to improve their self-care behaviours. Consequently, policy-makers and planners can use the results to set appropriate policies.",2020,The findings will provide valuable evidences regarding the efficacy of the educational intervention and will help the participants to improve their self-care behaviours.,"['relatives of esophageal cancer patients', 'two phases in Golestan province, located in north of Iran']",['educational program'],[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0227146,The findings will provide valuable evidences regarding the efficacy of the educational intervention and will help the participants to improve their self-care behaviours.,"[{'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Gerayllo', 'Affiliation': 'Department of Health, School of Public Health, Golestan Faculty of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali Morowatisharifabad', 'Affiliation': 'Department of Health Education & Promotion, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jouybari', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Karimiankakolaki', 'Affiliation': 'Department of Health, Faculty of Medical Sciences, Shahrekord Branch, Islamic Azad University, Shahrekord, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Public Health, School of Public Health, Sirjan Faculty of Medical Sciences, Sirjan, Iran.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.09.001']
1472,33103032,Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.,"Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate ( n  = 11) or placebo ( n  = 13). Average age was 56 ± 7 years, 83% were female (63% postmenopausal), and 21% were black. The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m 2 ). The 10-year fracture risk was low (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one participants returned for 6-month follow-up testing (88% retention) with all ( n  = 3) loss to follow-up occurring in the risedronate group. Average number of pills taken among completers was 5.9 ± 0.4 and 6.0 ± 0.0 in the risedronate and placebo groups, respectively ( p  = 0.21), with active participants taking >80% of allotted pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not related, and none serious. All participants reported high satisfaction with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density in patients who had undergone a sleeve gastrectomy appears feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to inform the design of an appropriately powered trial.
Clinical Trial Registration


http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone Health. © 2020 The Authors.  JBMR Plus  published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.",2020,The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m 2 ).,"['24 older patients who had undergone sleeve gastrectomy in a 6\u2009month RCT examining the efficacy of 150-mg once-monthly', 'Seventy participants were referred, with 24 randomized (34% yield) to', 'patients who had undergone a', '2020', 'Average age was 56\u2009±\u20097\u2009years, 83% were female (63% postmenopausal), and 21% were black']","['Risedronate', 'Sleeve Gastrectomy', 'risedronate', 'risedronate and placebo', 'placebo', 'sleeve gastrectomy', 'bisphosphonates', 'Bisphosphonate therapy', 'risedronate (versus placebo']","['osteoporotic fracture risk', 'skeletal fragility and fracture risk', 'surgical weight-loss-associated bone loss', '10-year fracture risk', 'baseline BMI', 'Weight Loss', 'Bone Loss', 'Average number of pills taken']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C4510264', 'cui_str': 'Bisphosphonate therapy'}]","[{'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",70.0,0.526013,The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m 2 ).,"[{'ForeName': 'Ashlyn A', 'Initials': 'AA', 'LastName': 'Swafford', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Science Wake Forest School of Medicine Winston-Salem NC USA.'}, {'ForeName': 'Peri C', 'Initials': 'PC', 'LastName': 'Gearren', 'Affiliation': 'Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.'}, {'ForeName': 'Adolfo Z', 'Initials': 'AZ', 'LastName': 'Fernandez', 'Affiliation': 'Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Ford', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem NC USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Kammire', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}, {'ForeName': 'Beverly A', 'Initials': 'BA', 'LastName': 'Nesbit', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}, {'ForeName': 'Kylie K', 'Initials': 'KK', 'LastName': 'Reed', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Weaver', 'Affiliation': 'Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem NC USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.'}]",JBMR plus,['10.1002/jbm4.10407']
1473,33103093,Gadoxetic acid-based hepatobiliary MRI in hepatocellular carcinoma.,"Background & Aims


SORAMIC is a prospective phase II randomised controlled trial in hepatocellular carcinoma (HCC). It consists of 3 parts: a diagnostic study and 2 therapeutic studies with either curative ablation or palliative Yttrium-90 radioembolisation combined with sorafenib. We report the diagnostic cohort study aimed to determine the accuracy of gadoxetic acid-enhanced magnetic resonance imaging (MRI), including hepatobiliary phase (HBP) imaging features compared with contrast-enhanced computed tomography (CT). The primary objective was the accuracy of treatment decisions stratifying patients for curative or palliative (non-ablation) treatment.
Methods


Patients with clinically suspected HCC underwent gadoxetic acid-enhanced MRI (HBP MRI, including dynamic MRI) and contrast-enhanced CT. Blinded read of the image data was performed by 2 reader groups (radiologists, R1 and R2). A truth panel with access to all clinical data and follow-up imaging served as reference. Imaging criteria for curative ablation were defined as up to 4 lesions <5 cm and absence of macrovascular invasion. The primary endpoint was non-inferiority of HBP MRI  vs.  CT in a first step and superiority in a second step.
Results


The intent-to-treat population comprised 538 patients. Treatment decisions matched the truth panel assessment in 83.3% and 81.2% for HBP MRI (R1 and R2), and 73.4% and 70.8% for CT. Non-inferiority and superiority (second step) of HBP MRI  vs.  CT were demonstrated (odds ratio 1.14 [1.09-1.19]). HBP MRI identified patients with >4 lesions significantly more frequently than CT.
Conclusions


In HCC, HBP MRI provided a more accurate decision than CT for a curative  vs.  palliative treatment strategy.
Lay summary


Patients with hepatocellular carcinoma are allocated to curative or palliative treatment according to the stage of their disease. Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.",2020,Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.,"['hepatocellular carcinoma (HCC', 'Lay summary\n\n\nPatients with hepatocellular carcinoma', 'hepatocellular carcinoma', 'patients for curative or palliative (non-ablation) treatment']","['gadoxetic acid-enhanced magnetic resonance imaging (MRI', 'Gadoxetic acid-based hepatobiliary MRI', 'contrast-enhanced computed tomography (CT', 'gadoxetic acid-enhanced MRI', 'CT', 'gadoxetic acid-enhanced MRI (HBP MRI, including dynamic MRI) and contrast-enhanced CT', 'curative ablation or palliative Yttrium-90 radioembolisation combined with sorafenib']",['non-inferiority of HBP MRI'],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3489483', 'cui_str': 'gadoxetic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0303596', 'cui_str': 'Yttrium-90'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",,0.0609449,Hepatobiliary imaging using gadoxetic acid-enhanced MRI is more accurate than CT for treatment decision-making.,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Ingo G', 'Initials': 'IG', 'LastName': 'Steffen', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bargellini', 'Affiliation': 'Department of Interventional Radiology, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Klinik und Poliklinik für Gastroenterologie, Sektion Hepatologie, Universitätsklinikum Leipzig AöR, Leipzig, Germany.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Bilbao Jaureguizar', 'Affiliation': 'Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Gebauer', 'Affiliation': 'Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iezzi', 'Affiliation': 'Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radiologia, Rome, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loewe', 'Affiliation': 'Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Musturay', 'Initials': 'M', 'LastName': 'Karçaaltincaba', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Pech', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sengel', 'Affiliation': 'Radiologie interventionnelle vasculaire et percutanée, CHU de Grenoble, Grenoble, France.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'van Delden', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vandecaveye', 'Affiliation': 'Department of Radiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Zech', 'Affiliation': 'Radiology and Nuclear Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}]",JHEP reports : innovation in hepatology,['10.1016/j.jhepr.2020.100173']
1474,33103139,"Effects of Minimal Flow Sevoflurane or Desflurane Anaesthesia on Hemodynamic Parameters, Body Temperature and Anaesthetic Consumption.","Objective


We aimed to compare minimal flow sevoflurane and desflurane anaesthesia in terms of hemodynamic parameters, body temperature, anaesthetic gas consumption and cost.
Methods


120 patients with ASA I-II (>18yo) who underwent elective surgery for longer than 60 min after general anaesthesia were randomized into two groups. The Dräger Perseus ®  A500 workstation was used. Pre-oxygenation was performed for 3 min with 6 L min -1  to 100% oxygen. Fractional inspirium oxygen concentration (FiO 2 ) was reduced to 40%, fresh gas flow was 4 L min -1  after intubation. Sevoflurane or desflurane was started at 1.5 minimal alveolar concentration (MAC). When the MAC value reached 0.9, fresh gas flow was reduced to 0.5 L min -1 , FiO 2  was increased to 68%. At the end of the surgery, the vaporizer was switched off, the fresh gas flow was increased (4 L min -1 , FiO 2  100%). When the train-of-four (TOF) ratio was 100%, extubation was carried out.
Results


There were no differences in patient characteristics and initial hemodynamic parameters of the groups. There were statistically significant differences between the times to reach 0.9 MAC, extubation and eye opening; anaesthetic, O 2  and air consumption in both groups.
Conclusion


With minimal flow, the time to reach target MAC, time to extubation and eye opening were significantly faster for desflurane and anaesthetic, oxygen and air consumption in desflurane anaesthesia were less than sevoflurane. Thus, we can say that desflurane has faster anaesthetic induction and recovery time with lower anaesthetic consumption than sevoflurane.",2020,"There were statistically significant differences between the times to reach 0.9 MAC, extubation and eye opening; anaesthetic, O 2  and air consumption in both groups.
",['120 patients with ASA I-II (>18yo) who underwent elective surgery for longer than 60 min after general anaesthesia'],"['sevoflurane and desflurane anaesthesia', 'Minimal Flow Sevoflurane or Desflurane Anaesthesia', 'desflurane', 'Sevoflurane or desflurane', 'sevoflurane']","['desflurane and anaesthetic, oxygen and air consumption', 'Hemodynamic Parameters, Body Temperature and Anaesthetic Consumption', 'patient characteristics and initial hemodynamic parameters', 'hemodynamic parameters, body temperature, anaesthetic gas consumption and cost', 'time to reach target MAC, time to extubation and eye opening', 'times to reach 0.9 MAC, extubation and eye opening; anaesthetic, O 2  and air consumption', 'Fractional inspirium oxygen concentration (FiO 2 ', 'fresh gas flow']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow'}]",120.0,0.0218941,"There were statistically significant differences between the times to reach 0.9 MAC, extubation and eye opening; anaesthetic, O 2  and air consumption in both groups.
","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Taşkın', 'Affiliation': 'Department of Anaesthesiology, Başkent University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Gedik', 'Affiliation': 'Department of Anaesthesiology, Başkent University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Kayhan', 'Affiliation': 'Department of Anaesthesiology, Başkent University School of Medicine, Ankara, Turkey.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2020.39699']
1475,33103140,Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Transverse Abdominis plane Block for Laparoscopic appendicectomy: A Randomised Controlled Study.,"Objective


Dexmedetomidine is an alpha 2-adrenergic agonist that prolongs analgesia as an adjuvant when added in neuraxial and peripheral nerve blocks. The aim of the present study was to evaluate the efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound (USG)-guided transverse abdominis plane (TAP) block for postoperative analgesia in laparoscopic appendicectomy.
Methods


A total of 60 American Society of Anesthesiologists I and II adult patients aged between 16 and 60 years planned for laparoscopic appendicectomy were randomised into two groups (A and B). Group A patients received 20 mL of 0.125% bupivacaine+1 μg kg -1  dexmedetomidine, whereas group B patients received 20 mL of 0.125% bupivacaine alone on both sides at the time of USG-guided TAP block. Haemodynamic variables, pain scores, sedation scores, time to first dose of rescue analgesic and side effects, if any, were assessed and compared between the groups.
Results


Demographic and operative characteristics were comparable in both groups. The mean duration of analgesia was more in group A (7.33 h) than in group B (4.8 h). The requirement of rescue analgesics was more in group B (80%) than in group A (56.7%). The sedation and pain scores at 2, 4 and 6 h were better in group A than in group B (p<0.05). The heart rate, systolic blood pressure and diastolic blood pressure were lower in group A during the postoperative period than in group B.
Conclusion


The addition of dexmedetomidine as an adjuvant to bupivacaine in TAP block provides prolonged postoperative analgesia and better pain control with reduced need for rescue analgesics than bupivacaine alone in patients undergoing laparoscopic appendicectomy.",2020,"The sedation and pain scores at 2, 4 and 6 h were better in group A than in group B (p<0.05).","['60 American Society of Anesthesiologists I and II adult patients aged between 16 and 60 years planned for', 'Laparoscopic appendicectomy', 'patients undergoing laparoscopic appendicectomy']","['bupivacaine', 'Bupivacaine', 'laparoscopic appendicectomy', '20 mL of 0.125% bupivacaine+1 μg kg -1  dexmedetomidine', '20 mL of 0.125% bupivacaine', 'Dexmedetomidine', 'dexmedetomidine', 'ultrasound (USG)-guided transverse abdominis plane (TAP) block']","['mean duration of analgesia', 'sedation and pain scores', 'Haemodynamic variables, pain scores, sedation scores, time to first dose of rescue analgesic and side effects', 'requirement of rescue analgesics', 'heart rate, systolic blood pressure and diastolic blood pressure']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",60.0,0.136408,"The sedation and pain scores at 2, 4 and 6 h were better in group A than in group B (p<0.05).","[{'ForeName': 'Soma Ganesh Raja', 'Initials': 'SGR', 'LastName': 'Neethirajan', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Sri Ramachandra Medical College, Chennai, India.'}, {'ForeName': 'Santoshi', 'Initials': 'S', 'LastName': 'Kurada', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Sri Ramachandra Medical College, Chennai, India.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Parameswari', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Sri Ramachandra Medical College, Chennai, India.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.67689']
1476,33103141,The 'Cross-Legged Foetal Sitting Neuraxial Position': Is it Beneficial?-A Prospective Randomised Clinical Trial Via Ultrasonography.,"Objective


The primary aim of the present study was to compare the 'cross-legged foetal sitting position' (CFSP) with the 'sitting foetal position' (SFP) sonographically. The secondary aim was to compare their comfort.
Methods


A randomised, consecutive controlled, single-blinded trial was performed in Yeditepe University. A total of 50 healthy volunteers were included in the study. Exclusion criteria were body mass index (BMI) >40 kg m-2, lumbar hernia, scoliosis, history of spine surgery, lower back pain or trauma, especially pelvic or knee problems related to arthropathy and not able to do one/both of the two position techniques. The two positioning techniques were evaluated by ultrasonography (USG) and 5-point Numerical Rating Scale (5-NRS) patient satisfaction of comfort questionnaire. Seven outcomes via USG were evaluated, subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of right and left paraspinal muscles (RPM and LPM), interspinous gap opening (ISGO), mean of bilateral paraspinal muscle (MPM) and CFSP-SFP change (CFSP-SFP). Stretcher comfort, position comfort, lumbar comfort (LC) and abdominal comfort (AC) were evaluated by participants with the 5-NRS.
Results


In the CFSP, the mean ST and S-SP were significantly (p<0.0001) shorter, and LPM, RPM and MPM were significantly (p<0.0001) wider. The mean ISGO in the CFSP was significantly (p<0.0001) broader. The CFSP was significantly more comfortable than the SFP according to the LC (p=0.02). Only ISGO was found to be significantly broader in the male participant group (p=0.01) and in the BMI ≥25 group (p=0.02) according to CFSP-SFP.
Conclusion


Considering all ultrasonographic anatomical measurements and according to the 5-NRS related to LC, the CFSP appears to be more advantageous than the SFP as a neuraxial positioning technique.",2020,The CFSP was significantly more comfortable than the SFP according to the LC (p=0.02).,['50 healthy volunteers'],"['CFSP', ""cross-legged foetal sitting position' (CFSP) with the 'sitting foetal position' (SFP) sonographically"", 'Ultrasonography']","['mean ISGO', 'body mass index (BMI', 'Stretcher comfort, position comfort, lumbar comfort (LC) and abdominal comfort (AC', 'mean ST and S-SP', 'CFSP', 'subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of right and left paraspinal muscles (RPM and LPM), interspinous gap opening (ISGO), mean of bilateral paraspinal muscle (MPM) and CFSP-SFP change (CFSP-SFP', 'LPM, RPM and MPM', 'ultrasonography (USG) and 5-point Numerical Rating Scale (5-NRS) patient satisfaction of comfort questionnaire']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C0475506', 'cui_str': 'Ravens colored progressive matrices'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0555583,The CFSP was significantly more comfortable than the SFP according to the LC (p=0.02).,"[{'ForeName': 'Fatma Ferda', 'Initials': 'FF', 'LastName': 'Kartufan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Yeditepe University School of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Karatay', 'Affiliation': 'Department of Radiology, Ministry of Health İstanbul Provincial Health Directorate Istanbul Kartal Dr. Lütfi Kırdar Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Kızılcık', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Yeditepe University School of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Köner', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Yeditepe University School of Medicine, İstanbul-Turkey.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.41017']
1477,33103201,"Reducing Ageism with Brief Videos about Aging Education, Ageism, and Intergenerational Contact.","BACKGROUND AND OBJECTIVES


With an increasing older population, ageism continues to be a significant social issue. Interventions to reduce ageism and improve intergenerational contact are needed.
RESEARCH DESIGN AND METHODS


Building on the PEACE (Positive Education about Aging and Contact Experiences) model, undergraduates in an online experiment were randomly assigned to watch videos that provided education about aging, ageism, and positive intergenerational contact (experimental condition) or education about wallpaper (control condition).
RESULTS


In Part 1, 845 undergraduates in the experimental condition (vs. control condition) reported lower levels of ageism, less negative age stereotypes, more positive age stereotypes, and more aging knowledge in an immediate post-test. In Part 2 (1-6 weeks later), undergraduates in the experimental condition (vs. control condition) reported more positive age stereotypes in a delayed post-test.
DISCUSSION AND IMPLICATIONS


These findings highlight the promise of providing information about aging and positive intergenerational contact to reduce ageism. Brief online educational videos based on the PEACE model hold promise as an effective tool to reach a wide audience and reduce ageism.",2020,"In Part 1, 845 undergraduates in the experimental condition (vs. control condition) reported lower levels of ageism, less negative age stereotypes, more positive age stereotypes, and more aging knowledge in an immediate post-test.","['Building on the PEACE (Positive Education about Aging and Contact Experiences) model, undergraduates in an online experiment', '845 undergraduates in the experimental condition (vs. control condition']","['watch videos that provided education about aging, ageism, and positive intergenerational contact (experimental condition) or education about wallpaper (control condition']","['lower levels of ageism, less negative age stereotypes, more positive age stereotypes', 'positive age stereotypes']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0324637,"In Part 1, 845 undergraduates in the experimental condition (vs. control condition) reported lower levels of ageism, less negative age stereotypes, more positive age stereotypes, and more aging knowledge in an immediate post-test.","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Lytle', 'Affiliation': 'College of Arts and Letters, Stevens Institute of Technology, Hoboken, New Jersey.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Macdonald', 'Affiliation': 'Psychology Department, St Francis College, Brooklyn, New York.'}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Apriceno', 'Affiliation': 'Psychology Department, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Sheri R', 'Initials': 'SR', 'LastName': 'Levy', 'Affiliation': 'Psychology Department, Stony Brook University, Stony Brook, New York.'}]",The Gerontologist,['10.1093/geront/gnaa167']
1478,33103229,"Safety, Feasibility and Effectiveness of Pulse Methylprednisolone Therapy in Comparison with Intramuscular Adrenocorticotropic Hormone in Children with West Syndrome.","OBJECTIVE


To assess the feasibility, effectiveness, and safety of pulse methylprednisolone in comparison with intramuscular adrenocorticotropic hormone (ACTH) therapy in children with West syndrome (WS).
METHODS


This open-label, pilot study with a parallel-group assignment included 44 recently diagnosed children with WS. Methylprednisolone therapy was given as intravenous infusion at a dose of 30 mg/kg/d for five days followed by oral steroids 1 mg/kg gradually tapered over 5-6 wk. The efficacy outcomes included a cessation of epileptic spasms (as per caregiver reporting) and resolution of hypsarrhythmia on electroencephalogram; safety outcome was the frequency of various adverse effects.
RESULTS


By day 14 of therapy, 6/18 (33.3%) children in the methylprednisolone group and 10/26 (38.5%) children in the ACTH group achieved cessation of epileptic spasms [group difference - 5.2%; confidence interval (CI) -30.7 to 22.8; p = 0.73]. However, by six weeks of therapy, 4/18 (22.2%) children in the methylprednisolone group and 11/26 (42.3%) children in the ACTH group had cessation of epileptic spasms (group difference - 20.1%; CI -43.0 to 8.4; p = 0.17). Hypertension was more commonly observed in the ACTH group (10 children) than in the methylprednisolone group (2 children; p = 0.046). Pulse methylprednisolone therapy was relatively safe.
CONCLUSIONS


The study observed limited effectiveness of both ACTH and pulse methylprednisolone therapy, which may partially be due to preponderance of structural etiology and a long treatment lag. However, pulse methylprednisolone therapy appeared to be safe, tolerable, and feasible for management of WS.",2020,"By day 14 of therapy, 6/18 (33.3%) children in the methylprednisolone group and 10/26 (38.5%) children in the ACTH group achieved cessation of epileptic spasms [group difference - 5.2%; confidence interval (CI) -30.7 to 22.8; p = 0.73].","['children with West syndrome (WS', '44 recently diagnosed children with WS', 'Children with West Syndrome']","['Pulse Methylprednisolone Therapy', 'Intramuscular Adrenocorticotropic Hormone', 'ACTH', 'Pulse methylprednisolone therapy', 'methylprednisolone', 'Methylprednisolone therapy', 'intramuscular adrenocorticotropic hormone (ACTH) therapy', 'pulse methylprednisolone therapy', 'pulse methylprednisolone', 'ACTH and pulse methylprednisolone therapy']","['safe, tolerable, and feasible for management of WS', 'cessation of epileptic spasms (as per caregiver reporting) and resolution of hypsarrhythmia on electroencephalogram; safety outcome', 'Hypertension', 'feasibility, effectiveness, and safety', 'frequency of various adverse effects', 'Safety, Feasibility and Effectiveness', 'cessation of epileptic spasms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C1527366', 'cui_str': 'Salaam Seizures'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",44.0,0.0682628,"By day 14 of therapy, 6/18 (33.3%) children in the methylprednisolone group and 10/26 (38.5%) children in the ACTH group achieved cessation of epileptic spasms [group difference - 5.2%; confidence interval (CI) -30.7 to 22.8; p = 0.73].","[{'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Rajpurohit', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Madaan', 'Affiliation': 'Pediatric Neurology Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Sahu', 'Affiliation': 'Pediatric Neurology Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Singhi', 'Affiliation': 'Pediatric Neurology Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India. doctorpratibhasinghi@gmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03521-7']
1479,33103316,Randomized controlled study for the anti-aging effect of human adipocyte-derived mesenchymal stem cell media combined with niacinamide after laser therapy.,"BACKGROUND


Recent advancements in laser-assisted drug delivery have emphasized the importance of post-laser use of active ingredients.
AIMS


We evaluated the effect of topical post-laser treatment with adipocyte-derived stem cell-containing medium (ADSC-CM) in combination with niacinamide through a double-blind, randomized, vehicle-controlled study.
PATIENTS/METHODS


Twenty-five patients with aging skin underwent ablative fractional laser (AFL) treatment on both sides of the face for skin rejuvenation. Moisturizers with or without ADSC-CM plus 2% niacinamide was applied to the designated sides of faces for 3 weeks. The wrinkle and the melanin indices were assessed using a specialized digital photography analyzer. Additional in vitro assays were performed.
RESULTS


The wrinkle index, melanin index, patient satisfaction score, and the investigator's global esthetic improvement scale (GAIS) after use of ADSC-CM plus niacinamide were significantly higher than after use of the vehicle cream. The in vitro UVB irradiation assays with human keratinocytes showed decreased levels of pro-inflammatory cytokines upon incubation with ADSC-CM plus niacinamide, and the cell scratch assay displayed decreased MMP-1 and MMP-2 expression as well as increased Type 1 collagen expression.
CONCLUSIONS


We demonstrated that post-laser topical application of ADSC-CM in combination with niacinamide has anti-aging effect on skin.",2020,"The in vitro UVB irradiation assays with human keratinocytes showed decreased levels of pro-inflammatory cytokines upon incubation with ADSC-CM plus niacinamide, and the cell scratch assay displayed decreased MMP-1 and MMP-2 expression as well as increased Type 1 collagen expression.
",['Twenty-five patients with aging skin underwent'],"['Moisturizers with or without ADSC-CM plus 2% niacinamide', 'topical post-laser treatment with adipocyte-derived stem cell-containing medium (ADSC-CM', 'human adipocyte-derived mesenchymal stem cell media combined with niacinamide after laser therapy', 'ablative fractional laser (AFL) treatment on both sides of the face for skin rejuvenation']","[""wrinkle index, melanin index, patient satisfaction score, and the investigator's global esthetic improvement scale (GAIS) after use of ADSC-CM plus niacinamide"", 'MMP-1 and MMP-2 expression', 'levels of pro-inflammatory cytokines']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}]","[{'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C2001899', 'cui_str': 'MMP1 protein, human'}, {'cui': 'C0172537', 'cui_str': 'Gelatinase A'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",25.0,0.0774135,"The in vitro UVB irradiation assays with human keratinocytes showed decreased levels of pro-inflammatory cytokines upon incubation with ADSC-CM plus niacinamide, and the cell scratch assay displayed decreased MMP-1 and MMP-2 expression as well as increased Type 1 collagen expression.
","[{'ForeName': 'Young In', 'Initials': 'YI', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soomin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jemin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Bae', 'Initials': 'KB', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ju Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13767']
1480,33103326,Different physiotherapy protocols after coronary artery bypass graft surgery: A randomized controlled trial.,"BACKGROUND AND PURPOSE


The aim of this study was to investigate the influence of different physiotherapy protocols on heart rate variability (HRV) and hospital length of stay in older adults undergoing coronary artery bypass graft (CABG).
METHODS


Randomized controlled trial with allocation and researcher blinding and intention-to-treat analysis. Forty-eight patients undergoing CABG were randomly assigned to a control group (CG), early mobilization group (EMG), or virtual reality group (VRG). CG performed respiratory physiotherapy and metabolic exercises, the EMG performed cycle ergometer exercises and ambulation, and the VRG performed the same activities as the EMG, with the addition of two Nintendo Wii games during 3 postoperative days. The variables of heart rate variability on preoperative and fourth postoperative day, and time of discharge of hospital was analyzed.
RESULTS


The VRG presented a shorter hospital length of stay (p = 0.03). The CG showed a decline in HRV from the preoperative period to fourth postoperative day on square root of the mean of the squared differences between successive RR intervals (33.18 ± 9.89-9.74 ± 6.88, p < 0.05), standard deviation of all RR intervals (25.48 ± 7.50-15.23 ± 11.27, p < 0.05), and dispersion of points perpendicular to identity line (28.26 ± 21.6-2.73 ± 1.31, p < 0.05). The EMG and VRG presented a higher cardiac autonomic modulation compared to the CG (p < 0.05), with improved parasympathetic activity.
CONCLUSIONS


Different protocols of physiotherapy intervention affected autonomic modulation of the heart rate and hospital length of stay in patients undergoing CABG.",2020,"The EMG and VRG presented a higher cardiac autonomic modulation compared to the CG (p < 0.05), with improved parasympathetic activity.
","['older adults undergoing coronary artery bypass graft (CABG', 'patients undergoing CABG', 'Forty-eight patients undergoing CABG']","['CG performed respiratory physiotherapy and metabolic exercises, the EMG performed cycle ergometer exercises', 'physiotherapy protocols', 'physiotherapy intervention', 'coronary artery bypass graft surgery', 'control group (CG), early mobilization group (EMG), or virtual reality group (VRG']","['parasympathetic activity', 'HRV', 'autonomic modulation of the heart rate and hospital length of stay', 'cardiac autonomic modulation', 'shorter hospital length of stay', 'heart rate variability on preoperative and fourth postoperative day, and time of discharge of hospital', 'heart rate variability (HRV) and hospital length of stay']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",48.0,0.1032,"The EMG and VRG presented a higher cardiac autonomic modulation compared to the CG (p < 0.05), with improved parasympathetic activity.
","[{'ForeName': 'Breno Caldas', 'Initials': 'BC', 'LastName': 'Ribeiro', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Jadson José Guimarães da', 'Initials': 'JJGD', 'LastName': 'Poça', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Amanda Martins Cavalcante', 'Initials': 'AMC', 'LastName': 'Rocha', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Clícia Naeli Silva da', 'Initials': 'CNSD', 'LastName': 'Cunha', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Katiane da Costa', 'Initials': 'KDC', 'LastName': 'Cunha', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Luiz Fábio Magno', 'Initials': 'LFM', 'LastName': 'Falcão', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}, {'ForeName': 'Daniel da Costa', 'Initials': 'DDC', 'LastName': 'Torres', 'Affiliation': 'State Public Foundation Gaspar Vianna Clinical Hospital, Belem, Brazil.'}, {'ForeName': 'Larissa Salgado de Oliveira', 'Initials': 'LSO', 'LastName': 'Rocha', 'Affiliation': 'Universitary Center of Pará, Belem, Brazil.'}, {'ForeName': 'Rodrigo Santiago Barbosa', 'Initials': 'RSB', 'LastName': 'Rocha', 'Affiliation': 'Biological and Health Sciences Center, Para State University, Belem, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1882']
1481,33103379,Blended home-based exercise and dietary protein in community-dwelling older adults: a cluster randomized controlled trial.,"BACKGROUND


Effective and sustainable interventions are needed to counteract the decline in physical function and sarcopenia in the growing aging population. The aim of this study was to determine the 6 and 12 month effectiveness of blended (e-health + coaching) home-based exercise and a dietary protein intervention on physical performance in community-dwelling older adults.
METHODS


This cluster randomized controlled trial allocated 45 clusters of older adults already engaged in a weekly community-based exercise programme. The clusters were randomized to three groups with ratio of 16:15:14; (i) no intervention, control (CON); (ii) blended home-based exercise intervention (HBex); and (iii) HBex with dietary protein counselling (HBex-Pro). Both interventions used a tablet PC with app and personalized coaching and were targeting on behaviour change. The study comprised coached 6 month interventions with a 6 month follow-up. The primary outcome physical performance was assessed by modified Physical Performance Test (m-PPT). Secondary outcomes were gait speed, physical activity level (PAL), handgrip muscle strength, protein intake, skeletal muscle mass, health status, and executive functioning. Linear mixed models of repeated measured were used to assess intervention effects at 6 and 12 months.
RESULTS


The population included 245 older adults (mean age 72 ± 6.5 (SD) years), 71% female, and 54% co-morbidities observed. Dropout of the intervention was 18% at 6 months and 26% at 12 months. Participants were well functioning, based on an m-PPT score of 33.9 (2.8) out of 36. For the primary outcome m-PPT, no significant intervention effects (HBex, +0.03, P = 0.933; HBex-Pro, -0.13, P = 0.730) were found. Gait speed (+0.20 m/s, P = 0.001), PAL (+0.06, P = 0.008), muscle strength (+2.32 kg, P = 0.001), protein intake (+0.32 g/kg/day, P < 0.001), and muscle mass (+0.33 kg, P = 0.017) improved significantly in the HBex-Pro group compared with control group after 6 month intervention. The protein intake, muscle mass, and strength remained significantly improved after 12 months as compared with those of control. Health change and executive functioning improved significantly in both intervention groups after 6 months.
CONCLUSIONS


This HBex and dietary protein interventions did not change the physical performance (m-PPT) in community-dwelling older adults. Changes were observed in gait speed, PAL, muscle mass, strength, and dietary protein intake, in response to this combined intervention.",2020,HBex and dietary protein interventions did not change the physical performance (m-PPT) in community-dwelling older adults.,"['Participants were well functioning, based on an m-PPT score of 33.9 (2.8) out of 36', '245 older adults (mean age 72\xa0±\xa06.5 (SD)\xa0years), 71% female, and 54% co-morbidities observed', 'community-dwelling older adults', '45 clusters of older adults already engaged in a weekly community-based exercise programme']","['tablet PC with app and personalized coaching', 'blended (e-health + coaching) home-based exercise and a dietary protein intervention', 'no intervention, control (CON); (ii) blended home-based exercise intervention (HBex); and (iii) HBex with dietary protein counselling (HBex-Pro', 'HBex and dietary protein interventions', 'Blended home-based exercise and dietary protein']","['protein intake, muscle mass, and strength', 'modified Physical Performance Test (m-PPT', 'muscle mass', 'PAL', 'muscle strength', 'gait speed, physical activity level (PAL), handgrip muscle strength, protein intake, skeletal muscle mass, health status, and executive functioning', 'gait speed, PAL, muscle mass, strength, and dietary protein intake', 'Gait speed', 'physical performance', 'Health change and executive functioning', 'protein intake']","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",245.0,0.0571962,HBex and dietary protein interventions did not change the physical performance (m-PPT) in community-dwelling older adults.,"[{'ForeName': 'Jantine', 'Initials': 'J', 'LastName': 'van den Helder', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Sports and Nutrition (room B1.28), Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'CREATE-IT Applied Research, Faculty of Digital Media and Creative Industries, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Carliene', 'Initials': 'C', 'LastName': 'van Dronkelaar', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Sports and Nutrition (room B1.28), Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Sports and Nutrition (room B1.28), Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tieland', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Sports and Nutrition (room B1.28), Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Visser', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Ben J A', 'Initials': 'BJA', 'LastName': 'Kröse', 'Affiliation': 'CREATE-IT Applied Research, Faculty of Digital Media and Creative Industries, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Center of Expertise Urban Vitality, Faculty of Sports and Nutrition (room B1.28), Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12634']
1482,33103385,"Microbiota profile and efficacy of probiotic supplementation on laxation in adults affected by Prader-Willi Syndrome: A randomized, double-blind, crossover trial.","BACKGROUND


Probiotics may provide a benefit for adults with Prader-Willi syndrome (PWS) experiencing constipation. The primary aim was to determine if Bifidobacterium animalis ssp. lactis B94 (B.lactis B94) improves stool frequency, with secondary aims of stool form and gastrointestinal symptoms. Exploratory aims included diet quality and fecal microbiota composition.
METHODS


Following a 4-week baseline, 25 adults with PWS were randomized to consume B.lactis B94 by capsule (15 billion) or placebo for 4 weeks, followed by 4-week washout in a double-blind, crossover design. Stool frequency and Bristol Stool Form (BSF) were assessed daily, and Gastrointestinal Symptom Rating Scale (GSRS) and dietary intake (7-days food records), per period. Fecal microbiota per period was analyzed using 16S rRNA gene amplicon sequencing and taxa of interest by qPCR (n = 24).
RESULTS


No adverse events were reported. Stool frequency at baseline (n = 25; 2.0 ± 0.1 stools/day), GSRS syndromes, and microbiota composition did not differ with the probiotic intervention overall; however, a delayed, carry-over effect on BSF types 6 and 7 was seen. Diet quality by HEI-2015 was 65.4 ± 8.5.
CONCLUSION


In adults with PWS, B.lactis B94 exhibited little effect on laxation over 4 weeks; however, further research is needed.",2020,"Stool frequency and Bristol Stool Form (BSF) were assessed daily, and Gastrointestinal Symptom Rating Scale (GSRS) and dietary intake (7-days food records), per period.","['adults affected by Prader-Willi Syndrome', '25 adults with PWS', 'adults with Prader-Willi syndrome (PWS) experiencing constipation']","['placebo', 'probiotic supplementation', 'consume B.lactis']","['Stool frequency', 'Gastrointestinal Symptom Rating Scale (GSRS) and dietary intake (7-days food records), per period', 'Stool frequency and Bristol Stool Form (BSF', 'stool frequency, with secondary aims of stool form and gastrointestinal symptoms', 'adverse events', 'lactis\xa0B94 (B.lactis', 'Diet quality', 'GSRS syndromes, and microbiota composition', 'diet quality and fecal microbiota composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439531', 'cui_str': '/period'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",25.0,0.620897,"Stool frequency and Bristol Stool Form (BSF) were assessed daily, and Gastrointestinal Symptom Rating Scale (GSRS) and dietary intake (7-days food records), per period.","[{'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alyousif', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Miller', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Auger', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Sandoval', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Piano', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Tompkins', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montreal, QC, Canada.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Dahl', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Florida, Gainesville, FL, USA.'}]",Molecular genetics & genomic medicine,['10.1002/mgg3.1535']
1483,33103389,[THE EFFECT OF MUSIC IN PRETERM ON RESTING ENERGY EXPENDITURE - A PROSPECTOVE RANDOMIZED CLINICAL TRIAL].,"BACKGROUND


We have recently showed that Wolfgang Amadeus Mozart's music significantly lowers resting energy expenditure (REE) in preterm infants. Whether or not this effect is specific to Mozart is unknown.
OBJECTIVES


To study whether familiar (""ethnic"") music has the same effect on REE in preterm infants as music by Mozart.
METHODS


A prospective, randomized clinical trial with cross-over was conducted in 9 healthy, appropriate weights for gestational age, gavage fed, preterm infants. Infants were randomized to be exposed to a 30-minute period of Mozart music or ""ethnic"" music or no music over 3 consecutive days. Metabolic measurements were performed by indirect calorimetry.
RESULTS


A total of 27 REE measurements were performed. On average REE was lower in preterm infants who were exposed to ""ethnic"" music compared to preterm infants who were exposed to music by Mozart (p=0.388). REE was lower in preterm infants who didn't listen to music at all compared to Mozart (p=0.014) or to ""ethnic"" (p=0.134).
CONCLUSIONS


Exposure to music by Mozart significantly elevated REE in healthy preterm infants compared to preterm infants who didn't listen to music at all. Nevertheless a trend of lower REE was demonstrated when preterm infants listened to ""ethnic"" music compared to Mozart.
DISCUSSION


We were unable to demonstrate a significant decrease in REE by exposure of preterm infants to Mozart- or ""familiar"" music. At this time point we cannot recommend music therapy for preterm infants in order to lower the REE. We speculate that a larger study sample might show a definite effect.",2020,"REE was lower in preterm infants who didn't listen to music at all compared to Mozart (p=0.014) or to ""ethnic"" (p=0.134).
","['preterm infants', 'preterm infants as music by Mozart', 'healthy preterm infants', '9 healthy, appropriate weights for gestational age, gavage fed, preterm infants']","['Mozart music or ""ethnic"" music or no music', 'familiar (""ethnic"") music']","['elevated REE', 'resting energy expenditure (REE', 'average REE', 'REE']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",27.0,0.165852,"REE was lower in preterm infants who didn't listen to music at all compared to Mozart (p=0.014) or to ""ethnic"" (p=0.134).
","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Ovental', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Department of Pediatrics, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Ronella', 'Initials': 'R', 'LastName': 'Marom', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Berger', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Raskind', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Haham', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Mandel', 'Affiliation': ""Department of Neonatology, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}]",Harefuah,[]
1484,33103448,"Effects of carbohydrate restriction on postprandial glucose metabolism, beta-cell function, gut hormone secretion, and satiety in patients with type 2 diabetes.","Background & Aims Dietary carbohydrate-restriction may improve the phenotype of type 2 diabetes (T2D) patients. We aimed to investigate 6 weeks of carbohydrate-restriction on postprandial glucose metabolism, pancreatic alpha- and beta-cell function, gut hormone secretion, and satiety in T2D patients. Methods In a cross-over design, 28 T2D patients (mean: HbA 1c  60 mmol/mol) were randomized to 6 weeks of carbohydrate-reduced high-protein (CRHP) diet and 6 weeks of conventional diabetes (CD) diet (energy-percentage carbohydrate/protein/fat: 30/30/40 versus 50/17/33). Twenty-four-hour continuous glucose monitoring (CGM) and mixed meal tests were undertaken and fasting intact proinsulin (IP), 32,33 split proinsulin concentrations (SP), and postprandial insulin secretion rates (ISR), insulinogenic index (IGI), beta-cell sensitivity to glucose (B up ), glucagon and gut hormones were measured. Gastric emptying was evaluated by postprandial paracetamol concentrations and satiety by visual analogue scale ratings. Results A CRHP diet reduced: postprandial glucose area under curve (net AUC) by 60% (p<0.001), 24h glucose by 13% (p<0.001), fasting IP and SP concentrations (both absolute and relative to C-peptide, p<0.05), and postprandial ISR (24%, p=0.015), while IGI and B up  improved by 31% and 45% (both p<0.001). The CRHP diet increased postprandial glucagon net AUC by 235% (p<0.001), subjective satiety by 18% (p=0.03), delayed gastric emptying by 15 minutes (p<0.001), decreased gastric inhibitory polypeptide net AUC by 29% (p<0.001), but had no significant effect on glucagon-like-peptide-1, total peptide YY and cholecystokinin responses. Conclusions A CRHP diet reduced glucose excursions and improved beta-cell function, including proinsulin processing, and increased subjective satiety in patients with T2D.",2020,"The CRHP diet increased postprandial glucagon net AUC by 235% (p<0.001), subjective satiety by 18% (p=0.03), delayed gastric emptying by 15 minutes (p<0.001), decreased gastric inhibitory polypeptide net AUC by 29% (p<0.001), but had no significant effect on glucagon-like-peptide-1, total peptide YY and cholecystokinin responses.","['patients with type 2 diabetes', 'T2D patients', 'patients with T2D', 'type 2 diabetes (T2D) patients', '28 T2D patients (mean: HbA 1c  60 mmol/mol']","['carbohydrate restriction', 'carbohydrate-restriction', 'carbohydrate-reduced high-protein (CRHP) diet and 6 weeks of conventional diabetes (CD) diet (energy-percentage carbohydrate/protein/fat']","['gastric inhibitory polypeptide net AUC', ' postprandial glucose area under curve (net AUC', 'postprandial ISR', 'postprandial glucagon net AUC', 'IGI and B up', 'subjective satiety', 'glucagon-like-peptide-1, total peptide YY and cholecystokinin responses', 'postprandial glucose metabolism, pancreatic alpha- and beta-cell function, gut hormone secretion, and satiety', 'Gastric emptying', 'fasting IP and SP concentrations', 'delayed gastric emptying', 'postprandial paracetamol concentrations and satiety by visual analogue scale ratings', 'postprandial glucose metabolism, beta-cell function, gut hormone secretion, and satiety', 'glucose excursions and improved beta-cell function, including proinsulin processing, and increased subjective satiety', 'fasting intact proinsulin (IP), 32,33 split proinsulin concentrations (SP), and postprandial insulin secretion rates (ISR), insulinogenic index (IGI), beta-cell sensitivity to glucose (B up ), glucagon and gut hormones']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0312431', 'cui_str': 'Hormone secretion'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",28.0,0.0129508,"The CRHP diet increased postprandial glucagon net AUC by 235% (p<0.001), subjective satiety by 18% (p=0.03), delayed gastric emptying by 15 minutes (p<0.001), decreased gastric inhibitory polypeptide net AUC by 29% (p<0.001), but had no significant effect on glucagon-like-peptide-1, total peptide YY and cholecystokinin responses.","[{'ForeName': 'Mads Juul', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Endocrinology, Odense University Hospital.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation (NNF) Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Dept. of Endocrinology, Hvidovre Hospital, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Burling', 'Affiliation': 'Core Biochemical Assa Laboratory, Cambridge University Hospital NHS foundation Trust, United Kingdom.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Dept. of Clinical Biochemistry, Hvidovre Hospital, Denmark.'}, {'ForeName': 'Mads N', 'Initials': 'MN', 'LastName': 'Thomsen', 'Affiliation': 'Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Steen Bendix', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00165.2020']
1485,33103453,Effect of Hypoxic Exercise on Glucose Tolerance in Healthy and Pre-diabetic Adults.,"PURPOSE


This study aimed to investigate the mechanisms known to regulate glucose homeostasis in human skeletal muscle of healthy and pre-diabetic subjects exercising in normobaric hypoxia.
METHODS


Seventeen healthy (H; 28.8±2.4y; VO 2 max: 45.1±1.8mL·kg -1 ·min -1 ) and fifteen pre-diabetic (P; 44.6±3.9y; VO 2 max: 30.8±2.5mL·kg -1 ·min -1 ) men were randomly assigned to two groups performing an acute exercise bout (heart rate corresponding to 55% VO 2 max) either in normoxic (NE) or in hypoxic (HE; FiO 2  14.0%) conditions. An oral glucose tolerance test (OGTT) was performed in a basal state and after an acute exercise bout. Muscle biopsies from m. vastus lateralis were taken before and after exercise. Venous blood samples were taken at regular intervals before, during and after exercise.
RESULTS


The two groups exercising in hypoxia had a larger area under the curve of blood glucose levels during the OGTT after exercise compared to baseline (H: +4%; P: +11%). Compared to pre-exercise, an increase in p-TBC1D1 Ser 237  and in p-AMPK Thr 172  was observed post-exercise in P NE (+95%; +55%, respectively) and H HE (+91%; +43%, respectively). An increase in p-ACC Ser 212  was measured after exercise in all groups (H NE: +228%; P NE: +252%; H HE: +252%; P HE: +208%).
CONCLUSIONS


Our results show that an acute bout of exercise in hypoxia reduces glucose tolerance in healthy and pre-diabetic subjects. At a molecular level, some adaptations regulating glucose transport in muscle were found in all groups without associations with glucose tolerance after exercise. The results suggest that hypoxia negatively affects glucose tolerance post-exercise through unidentified mechanisms.",2020,"Compared to pre-exercise, an increase in p-TBC1D1 Ser 237  and in p-AMPK Thr 172  was observed post-exercise in P NE (+95%; +55%, respectively) and H HE (+91%; +43%, respectively).","['human skeletal muscle of healthy and pre-diabetic subjects exercising in normobaric hypoxia', 'healthy and pre-diabetic subjects', '30.8±2.5mL·kg -1 ·min -1 ) men', 'Seventeen healthy (H; 28.8±2.4y; VO 2 max', 'Healthy and Pre-diabetic Adults']","['Hypoxic Exercise', 'acute exercise bout (heart rate corresponding to 55% VO 2 max) either in normoxic (NE) or in hypoxic (HE; FiO 2  14.0%) conditions']","['blood glucose levels', 'Venous blood samples', 'glucose tolerance', 'p-ACC', 'Glucose Tolerance']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}]",17.0,0.0224503,"Compared to pre-exercise, an increase in p-TBC1D1 Ser 237  and in p-AMPK Thr 172  was observed post-exercise in P NE (+95%; +55%, respectively) and H HE (+91%; +43%, respectively).","[{'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'De Groote', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Britto', 'Affiliation': 'Université de Montpellier, INRAE, DMEM, Montpellier.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Balan', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Warnier', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Diabetes and Nutrition Unit, University of Louvain, Belgium.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Nielens', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Lykke', 'Initials': 'L', 'LastName': 'Sylow', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Université Catholique de Louvain.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00263.2020']
1486,33103499,The effect of innovative smartphone application on adherence to a home-based exercise programs for female older adults with knee osteoarthritis in Saudi Arabia: a randomized controlled trial.,"PURPOSE


To examine the effects of an Arabic smartphone application on adherence to home exercise programs (HEPs) and the effectiveness of mobile-based HEPs on pain, physical function, and lower-limb muscle strength among older women with knee osteoarthritis (OA).
MATERIALS AND METHODS


This randomised control trial (ClinicalTrials.gov: (NCT04159883) enrolled 40 women aged ≥50 years with knee OA who were randomised into the app group (experimental;  n  = 20) receiving HEPs using an Arabic smartphone application called ""My Dear Knee"", whereas the paper group (control;  n  = 20) receiving HEPs as hand-outs. Both groups had the same exercise program. Outcome measures were self-reported adherence, changes in the Arabic Numeric Pain Rating Scale, the Arabic version of the reduced Western Ontario, McMaster Universities Osteoarthritis Index-Physical Function subscale, and Five-Times Sit-To-Stand Test scores. All participants were assessed at baseline, at week 3 and week 6. Using completer-only analyses, the repeated measures ANOVA was used to compare the means of the outcome measures between the two groups.
RESULTS


At the end of week 6, the app group reported greater adherence to HEPs ( p  = .002) and significant reduction in pain ( p  = .015).
CONCLUSIONS


A smartphone application with motivational and attractive features could enhance adherence to HEPs in this patient cohort. IMPLICATIONS FOR REHABILITATION Older adults with knee OA may face many obstacles that prevent or limit their adherence to the prescribed HEP. Smart device apps supported with attractive and motivational features could be an effective strategy to enhance adherence to HEPs among older adults with knee OA. Using such remote technology appears to overcome the barriers that may limit the ability of older women to receive supervised physical therapy in a clinical setting.",2020,"At the end of week 6, the app group reported greater adherence to HEPs ( p  = .002) and significant reduction in pain ( p  = .015).
","['older adults with knee OA', 'female older adults with knee osteoarthritis in Saudi Arabia', '40 women aged ≥50\u2009years with knee OA', 'older women', 'Older adults with knee OA', 'older women with knee osteoarthritis (OA']","['app group (experimental;  n \u2009=\u200920) receiving HEPs using an Arabic smartphone application called ""My Dear Knee"", whereas the paper group (control;  n \u2009=\u200920) receiving HEPs as hand-outs', 'mobile-based HEPs', 'innovative smartphone application', 'supervised physical therapy', 'Arabic smartphone application']","['self-reported adherence, changes in the Arabic Numeric Pain Rating Scale, the Arabic version of the reduced Western Ontario, McMaster Universities Osteoarthritis Index-Physical Function subscale, and Five-Times Sit-To-Stand Test scores', 'pain, physical function, and lower-limb muscle strength', 'pain', 'adherence to HEPs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]",40.0,0.054243,"At the end of week 6, the app group reported greater adherence to HEPs ( p  = .002) and significant reduction in pain ( p  = .015).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Alasfour', 'Affiliation': 'Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Almarwani', 'Affiliation': 'Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1836268']
1487,33103504,Lung sonography can improve the specificity of determination of left-sided double-lumen tracheal tube position in both novices and experts: a randomised prospective study.,"OBJECTIVE


Lung sonography can be helpful to determine the position of a left-sided double-lumen tube (DLT). However, clinical experience is required for correct assessment. We investigated whether lung sonography can improve the diagnostic efficacy of determining the DLT position in novices and experts.
METHODS


In this randomised prospective clinical study, 88 patients were allocated to two groups using auscultation or lung sonography for initial assessment of the DLT position. In each group, two repeated assessments were performed; the first was performed by a novice, and the second was performed by an expert. The final DLT position was confirmed by fibre-optic bronchoscopy. The primary outcome was the diagnostic efficacy (including overall accuracy, sensitivity, and specificity) in confirming the DLT position.
RESULTS


In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively). Additionally, the predictability of an incorrect position was similar between the novices and experts using lung sonography (area under the curve of 0.665 and 0.690, respectively).
CONCLUSIONS


Lung sonography can improve the diagnostic efficacy of detecting an incorrect DLT position in both novices and experts.",2020,"In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively).",['88 patients'],"['Lung sonography', 'auscultation or lung sonography for initial assessment of the DLT position']","['diagnostic efficacy', 'specificity of determining the DLT position', 'diagnostic efficacy (including overall accuracy, sensitivity, and specificity', 'predictability of an incorrect position']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",88.0,0.0313097,"In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'YoonJu', 'Initials': 'Y', 'LastName': 'Go', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Department of Medicine, Graduate School, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Yong Seok', 'Initials': 'YS', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Bong-Jae', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Hyungseok', 'Initials': 'H', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}]",The Journal of international medical research,['10.1177/0300060520964369']
1488,33103585,A pilot project: handwashing educational intervention decreases incidence of respiratory and diarrheal illnesses in a rural Malawi orphanage.,"Children who live in orphanages represent a population particularly vulnerable to transmissible diseases. Handwashing interventions have proven efficacy for reducing the rate of transmission of common infectious diseases. Few studies have analyzed the delivery of health interventions for children in orphanages in sub-Saharan Africa. To address this gap, we conducted an ecological assessment and piloted a handwashing intervention in an orphanage in rural Malawi, focusing on caregiver knowledge and behaviors, child handwashing behaviors, and disease incidence. A secondary study aim was to demonstrate program feasibility for a future randomized controlled trial. Orphanage caregivers participated in a three-module educational intervention on handwashing based on WHO recommendations and workshops on how to teach the curriculum to children. Seventeen orphanage caregivers and 65 children were monitored for handwashing behavior and child disease incidence. Friedman's tests were conducted to compare changes in caregiver knowledge and behaviors. Child handwashing behaviors and surveillance of child disease incidence were measured pre- and post-intervention. There were significant increases in caregiver hand hygiene knowledge. At six months post-intervention, handwashing with soap increased significantly among caregivers ( p  < 0.001) and was observed in children. The incidence of acute respiratory infections decreased from 30% to 6% post-intervention, resulting in an 80% decrease. The incidence of diarrhea decreased from 9.2% to 6.2% post-intervention, resulting in a 33% decrease. A brief educational intervention may improve handwashing knowledge and behaviors and help to decrease the incidence of common infectious diseases in an orphanage in rural Malawi. In addition, the caregiver uptake of the intervention demonstrated feasibility for future studies.",2020,"At six months post-intervention, handwashing with soap increased significantly among caregivers ( p  < 0.001) and was observed in children.","['Orphanage caregivers participated in a three-module educational intervention on handwashing based on WHO recommendations and workshops on how to teach the curriculum to children', 'respiratory and diarrheal illnesses in a rural Malawi orphanage', 'Seventeen orphanage caregivers and 65 children', 'children in orphanages in sub-Saharan Africa']","['educational intervention', 'handwashing educational intervention']","['incidence of diarrhea', 'caregiver hand hygiene knowledge', 'incidence of acute respiratory infections', 'Child handwashing behaviors and surveillance of child disease incidence', 'caregiver knowledge and behaviors', 'handwashing behavior and child disease incidence']","[{'cui': 'C0337651', 'cui_str': 'Orphanage'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0465851,"At six months post-intervention, handwashing with soap increased significantly among caregivers ( p  < 0.001) and was observed in children.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rissman', 'Affiliation': ""Division of Pediatric Critical Care, Ann and Robert H. Lurie Children's Hospital of Chicago, USA.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Deavenport-Saman', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Corden', 'Affiliation': 'Department of Pediatrics, Keck School of Medicine, University of Southern California, USA.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Zipkin', 'Affiliation': 'Department of Pediatrics, Keck School of Medicine, University of Southern California, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Espinoza', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, Children's Hospital Los Angeles, USA.""}]",Global health promotion,['10.1177/1757975920963889']
1489,33103603,High-Dose Glucagon Has Hemodynamic Effects Regardless of Cardiac Beta-Adrenoceptor Blockade: A Randomized Clinical Trial.,"Background Intravenous high-dose glucagon is a recommended antidote against beta-blocker poisonings, but clinical effects are unclear. We therefore investigated hemodynamic effects and safety of high-dose glucagon with and without concomitant beta-blockade. Methods and Results In a randomized crossover study, 10 healthy men received combinations of esmolol (1.25 mg/kg bolus+0.75 mg/kg/min infusion), glucagon (50 µg/kg), and identical volumes of saline placebo on 5 separate days in random order (saline+saline; esmolol+saline; esmolol+glucagon bolus; saline+glucagon infusion; saline+glucagon bolus). On individual days, esmolol/saline was infused from -15 to 30 minutes. Glucagon/saline was administered from 0 minutes as a 2-minute intravenous bolus or as a 30-minute infusion (same total glucagon dose). End points were hemodynamic and adverse effects of glucagon compared with saline. Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0;  P <0.001), systolic blood pressure by 15.6 mm Hg (95% CI, 8.0-23.2;  P =0.002), diastolic blood pressure by 9.4 mm Hg (95% CI, 6.3-12.6;  P <0.001), and cardiac output by 18.0 % (95% CI, 9.7-26.9;  P =0.003) at the 5-minute time point on days without beta-blockade. Similar effects of glucagon bolus occurred on days with beta-blockade and between 15 and 30 minutes during infusion. Hemodynamic effects of glucagon thus reflected pharmacologic glucagon plasma concentrations. Glucagon-induced nausea occurred in 80% of participants despite ondansetron pretreatment. Conclusions High-dose glucagon boluses had significant hemodynamic effects regardless of beta-blockade. A glucagon infusion had comparable and apparently longer-lasting effects compared with bolus, indicating that infusion may be preferable to bolus injections. Registration Information URL: https://www.clinicaltrials.gov; Unique identifier: NCT03533179.",2020,"Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0;  P <0.001), systolic blood pressure by 15.6 mm ",['10 healthy men'],"['saline placebo', 'high-dose glucagon', 'esmolol/saline', 'glucagon', 'Glucagon/saline', 'saline, glucagon', 'Glucagon', 'esmolol (1.25\xa0mg/kg bolus+0.75\xa0mg/kg/min infusion), glucagon', 'ondansetron']","['pharmacologic glucagon plasma concentrations', 'cardiac output', 'mean heart rate', 'hemodynamic and adverse effects of glucagon', 'Glucagon-induced nausea', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1320756', 'cui_str': 'mg/kg/min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0413602', 'cui_str': 'Glucagon adverse reaction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",10.0,0.790041,"Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0;  P <0.001), systolic blood pressure by 15.6 mm ","[{'ForeName': 'Kasper M', 'Initials': 'KM', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Bøgevig', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Riis', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Niklas W', 'Initials': 'NW', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Kim P', 'Initials': 'KP', 'LastName': 'Dalhoff', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Medicine Herlev HospitalUniversity of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Tonny S', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016828']
1490,33103727,Development of standardized regression-based formulas to assess meaningful cognitive change in early Parkinson's disease.,"OBJECTIVE


Longitudinal assessment of cognitive and emotional functioning in patients with Parkinson's disease (PD) is helpful in tracking progression of the disease, developing treatment plans, evaluating outcomes, and educating patients and families. Determining whether change over time is meaningful in neurodegenerative conditions, such as PD, can be difficult as repeat assessment of neuropsychological functioning is impacted by factors outside of cognitive change. Regression-based prediction formulas are one method by which clinicians and researchers can determine whether an observed change is meaningful. The purpose of the current study was to develop and validate regression-based prediction models of cognitive and emotional test scores for participants with early-stage idiopathic PD and healthy controls (HC) enrolled in the Parkinson's Progression Markers Initiative (PPMI).
METHODS


Participants with de novo PD and HC were identified retrospectively from the PPMI archival database. Data from baseline testing and 12-month follow-up were utilized in this study. In total, 688 total participants were included in the present study (NPD = 508; NHC = 185). Subjects from both groups were randomly divided into development (70%) and validation (30%) subsets.
RESULTS


Early-stage idiopathic PD patients and healthy controls were similar at baseline. Regression-based models were developed for all cognitive and self-report mood measures within both populations. Within the validation subset, the predicted and observed cognitive test scores did not significantly differ, except for semantic fluency.
CONCLUSIONS


The prediction models can serve as useful tools for researchers and clinicians to study clinically meaningful cognitive and mood change over time in PD.",2020,"Within the validation subset, the predicted and observed cognitive test scores did not significantly differ, except for semantic fluency.
","['688 total participants were included in the present study (NPD\xa0=\xa0508; NHC\xa0=\xa0185', 'Participants with de novo PD and HC were identified retrospectively from the PPMI archival database', ""participants with early-stage idiopathic PD and healthy controls (HC) enrolled in the Parkinson's Progression Markers Initiative (PPMI"", ""patients with Parkinson's disease (PD"", ""early Parkinson's disease""]",[],"['cognitive test scores', 'cognitive and emotional test scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0068515', 'cui_str': 'neodymium pyrocatechin disulfonate'}, {'cui': 'C0268059', 'cui_str': 'Neonatal hemochromatosis'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],"[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",688.0,0.0231487,"Within the validation subset, the predicted and observed cognitive test scores did not significantly differ, except for semantic fluency.
","[{'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Combs', 'Affiliation': 'Houston Methodist.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Wyman-Chick', 'Affiliation': 'Health Partners Neuroscience Center.'}, {'ForeName': 'Lauren O', 'Initials': 'LO', 'LastName': 'Erickson', 'Affiliation': 'Health Partners Neuroscience Center.'}, {'ForeName': 'Michele K', 'Initials': 'MK', 'LastName': 'York', 'Affiliation': 'Baylor College of Medicine.'}]",Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists,['10.1093/arclin/acaa104']
1491,33103770,Combined treatment with valsartan and fluvastatin to delay disease progression in nonpermanent atrial fibrillation with hypertension: A clinical trial.,"BACKGROUND


Atrial fibrillation (AF) is a complex cardiac arrhythmia in clinical practice with increasing incidence. However, the effects of statins on patients with AF are not quite clear.
HYPOTHESIS


To investigate the protective effect of calcium channel blocker (CCB) and valsartan combined fluvastatin on hypertension (HTN) patients with nonpermanent AF.
METHODS


In three and a half years, 189 cases of patients diagnosed as HTN combining nonpermanent AF by eight medical centers, were recruited and randomly assigned to four groups with varied treatments: CCB group; CCB + statin group; valsartan group; and valsartan + statin group. The four groups were followed up for 24 months. The 7-day Holter ultrasound echocardiography (UCG) and biochemical indexes were completed at preset time nodes respectively.
RESULTS


After 24 months of follow-up, 178 patients completed the study. Compared with CCB group, the blood lipid level, inflammatory index, ultrasonic index and electrocardiographic measurement results of CCB + statin group, valsartan group and valsartan + statin group were improved in different degrees and had statistical significance (P < .05 or P < .01). Furthermore, the improvement trend of CCB + statin group and valsartan + statin group was more obvious.
CONCLUSIONS


The results indicated that valsartan can reduce AF load and recurrence rate, and delay the progression of nonpermanent AF to permanent AF in multiple ways, and the effect of combination of valsartan and fluvastatin is more significant. These results provide a new direction for the integrated upstream control strategy of AF.",2020,"Compared with CCB group, the blood lipid level, inflammatory index, ultrasonic index and electrocardiographic measurement results of CCB + statin group, valsartan group and valsartan + statin group were improved in different degrees and had statistical significance (P < .05 or P < .01).","['patients with AF', 'hypertension (HTN) patients with nonpermanent AF', '189 cases of patients diagnosed as HTN combining nonpermanent AF by eight medical centers', 'nonpermanent atrial fibrillation with hypertension', '178 patients completed the study']","['CCB', 'valsartan', 'valsartan\u2009+\u2009statin group', 'valsartan + statin', 'CCB\u2009+\u2009statin group; valsartan', 'calcium channel blocker (CCB) and valsartan combined fluvastatin', 'valsartan and fluvastatin']","['blood lipid level, inflammatory index, ultrasonic index and electrocardiographic measurement results of CCB', '7-day Holter ultrasound echocardiography (UCG) and biochemical indexes', 'AF load and recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0082608', 'cui_str': 'fluvastatin'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0230172,"Compared with CCB group, the blood lipid level, inflammatory index, ultrasonic index and electrocardiographic measurement results of CCB + statin group, valsartan group and valsartan + statin group were improved in different degrees and had statistical significance (P < .05 or P < .01).","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Zhaojie', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, An Zhen Hospital affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Geriatrics, the first hospital of Shijiazhuang City, Hebei, China.'}, {'ForeName': 'Enzhao', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}]",Clinical cardiology,['10.1002/clc.23487']
1492,33040474,Rubbing the skin when removing makeup cosmetics is a major factor that worsens skin conditions in atopic dermatitis patients.,"BACKGROUND


Many patients with atopic dermatitis (AD) know that harsh rubbing of their skin might worsen their skin symptoms. They consider that the force they use to rub their skin when removing their makeup cosmetics should not be hard and their cleansing habits could worsen their skin symptoms. However, we presume that the force they use to rub their skin may still be strong and might worsen their skin symptoms.
AIMS


We characterized the effects of rubbing the skin of AD patients during cleansing of makeup cosmetics.
PATIENTS/METHODS


A cleansing oil which has a higher cleansing ability compared the cleansers used daily by the subjects but required less rubbing force was used. We performed a 4-week clinical trial of this cleansing oil on 35 female subjects who had mild AD skin symptoms on their faces. Each subject used the cleansing oil instead of their usual makeup remover without changing their other facial skin care habits. Prior to the study, and at the end of weeks 1 and 4, the skin conditions of each subject were evaluated.
RESULTS


Four weeks of usage of this cleansing oil significantly decreased skin dryness, scaling, irritation, erythema, and itchiness. Higher improvements were observed for subjects who had previously used cleansers with less cleansing ability. Accompanying those improvements, a significant increase in moisture-retention ability and a significant decrease in transepidermal water loss were observed.
CONCLUSION


These results suggest that many AD patients cleanse their face with hard rubbing of their skin because of the low cleansing ability of their skin cleansers and may worsen their AD skin symptoms without realizing it.",2020,"Four weeks of usage of this cleansing oil significantly decreased skin dryness, scaling, irritation, erythema, and itchiness.","['atopic dermatitis patients', '35 female subjects who had mild AD skin symptoms on their faces', 'patients with atopic dermatitis (AD']",['cleansing oil'],"['transepidermal water loss', 'moisture-retention ability', 'skin dryness, scaling, irritation, erythema, and itchiness']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0586407', 'cui_str': 'Skin symptom'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",35.0,0.0168922,"Four weeks of usage of this cleansing oil significantly decreased skin dryness, scaling, irritation, erythema, and itchiness.","[{'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Hosokawa', 'Affiliation': 'Skin Care Products Research, Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Taima', 'Affiliation': 'Skin Care Products Research, Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Kikuchi', 'Affiliation': 'Skin Care Products Research, Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Tsuda', 'Affiliation': 'Skin Care Products Research, Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Numano', 'Affiliation': 'Numano Clinic, Gunma, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Skin Care Products Research, Kao Corporation, Tokyo, Japan.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13777']
1493,33070307,Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma: Final results of the MARC-2 trial.,"MARC-2, a prospective, multicenter phase IV trial, aimed to investigate clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy and to identify subgroups benefiting most, based on clinical characteristics and biomarkers. Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity. Primary endpoint was 6-month progression-free survival rate (6moPFS). Secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Between 2011 and 2015, 63 patients were enrolled. Median age was 65.4 years (range 43.3-81.1). 6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index (BMI) >25 vs ≤25 kg/m 2  . A Cox proportional hazards model confirmed a longer PFS for patients aged ≥65 years (hazard ratio [HR] 0.46; 95% CI, 0.26-0.80) and a longer OS for patients with BMI >25 kg/m 2  (HR 0.36; 95% CI, 0.18-0.71). Median PFS and median OS were 3.8 months (95% CI, 3.2-6.2) and 16.8 months (95% CI, 14.3-24.3). ORR was 7.9% and disease control rate was 60.3%. No new safety signals emerged. Most common adverse events were stomatitis (31.7%), fatigue (31.7%), and anemia (30.2%). One patient died from treatment-related upper gastrointestinal hemorrhage. Everolimus remains a safe and effective treatment option for mRCC patients after one prior VEGFR-TKI therapy. Patients aged ≥65 years and patients with BMI >25 kg/m 2  benefited most.",2020,"6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index","['metastatic renal cell carcinoma', 'patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor', 'Median age was 65.4\u2009years (range 43.3-81.1', '25', 'mRCC patients after one prior VEGFR-TKI therapy', 'Between 2011 and 2015, 63 patients were enrolled', 'Patients aged ≥65\u2009years and patients with BMI ', 'Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity']","['VEGF-targeted therapy', 'receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy', 'Everolimus']","['disease control rate', 'overall response rate (ORR), PFS, overall survival (OS), and safety', 'ORR', 'anemia', 'fatigue', 'Median PFS and median OS', '6-month progression-free survival rate (6moPFS', '6moPFS']","[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",63.0,0.323122,"6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Interdisciplinary Center of Renal Tumors, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology and Paediatric Urology, Saarland University Medical Center, Homburg (Saar), Germany.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Christoph', 'Affiliation': 'Department of Medical Oncology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Hospital Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Potthoff', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Klein', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Harde', 'Affiliation': 'Biostatistics, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Brüning', 'Affiliation': 'Department of Urology and Pediatric Urology, Philipps-University Marburg, University Hospital Giessen and Marburg GmbH, Marburg, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goebell', 'Affiliation': 'Department of Urology and Clinic for Haematology and Internistic Oncology, University Hospital Erlangen, Ambulatory Uro-Oncological Therapy Unit Erlangen (AURONTE), Erlangen, Germany.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Nuremberg, Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Roos', 'Affiliation': 'Department of Urology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Benz-Rüd', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Marschner', 'Affiliation': 'Outpatient-Centre for Interdisciplinary Oncology and Haematology, Freiburg, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, University Hospital Hannover Medical School, Hannover, Germany.'}]",International journal of cancer,['10.1002/ijc.33349']
1494,33099300,Correction to: Improving infant sleep safety via electronic health record communication: a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['electronic health record communication'],[],[],"[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],,0.155648,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Canty', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Fogel', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Erich K', 'Initials': 'EK', 'LastName': 'Batra', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Beiler', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA. ipaul@psu.edu.'}]",BMC pediatrics,['10.1186/s12887-020-02397-y']
1495,33099307,GP- and practice-related variation in ambulatory sensitive hospitalisations of older primary care patients.,"BACKGROUND


Reducing ambulatory sensitive hospitalisations (ASHs) is a strategy to control spending on hospital care and to improve quality of primary health care. This research investigated whether ASH rates in older people varied by GP and practice characteristics.
METHODS


We identified ASHs from the national dataset of hospital events for 3755 community-dwelling participants aged 75+ enrolled in a cluster randomised controlled trial involving 60 randomly selected general practices in three regions in New Zealand. Poisson mixed models of 36-month ASH rates were fitted for the entire sample, for complex participants, and non-complex participants. We examined variation in ASH rates according to GP- and practice-level characteristics after adjusting for patient-level predictors of ASH.
RESULTS


Lower rates of ASHs were observed in female GPs (IRR 0.83, CI 0.71 to 0.98). In non-complex participants, but not complex participants, practices in more deprived areas had lower ASH rates (4% lower per deprivation decile higher, IRR 0.96, CI 0.92 to 1.00), whereas main urban centre practices had higher rates (IRR 1.84, CI 1.15 to 2.96). Variance explained by these significant factors was small (0.4% of total variance for GP sex, 0.2% for deprivation, and 0.5% for area type). None of the modifiable practice-level characteristics such as home visiting and systematically contacting patients were significantly associated with ASH rates.
CONCLUSIONS


Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people. Where there were significant associations, the contribution to overall variance was minimal. It also remains unclear whether lower ASH rates in older people represents underservicing or less overuse of hospital services, particularly for the relatively well patient attending practices in less central, more disadvantaged communities. Thus, reducing ASHs through primary care redesign for older people should be approached carefully.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Register ACTRN12609000648224 .",2020,Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people.,"['We identified ASHs from the national dataset of hospital events for 3755 community-dwelling participants aged 75+ enrolled in a cluster randomised controlled trial involving 60 randomly selected general practices in three regions in New Zealand', 'older people varied by GP and practice characteristics', 'older primary care patients', 'Australian and New Zealand']",['GP- and practice-related variation'],"['ASH rates', '36-month ASH rates']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0994524', 'cui_str': 'Ash'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",60.0,0.115396,Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people.,"[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Palapar', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wilkinson-Meyers', 'Affiliation': 'Health Systems Section, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lumley', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ngaire', 'Initials': 'N', 'LastName': 'Kerse', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. n.kerse@auckland.ac.nz.'}]",BMC family practice,['10.1186/s12875-020-01285-9']
1496,33099503,"Correction: Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.",,2020,,[],"['Intensive Care Weaning (iCareWean) protocol', 'Correction']",[],[],"[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.132807,,[],BMJ open,['10.1136/bmjopen-2020-042145corr1']
1497,33099502,"Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.","INTRODUCTION


The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure. However, our previous studies have suggested that IPFP size was protective against, while IPFP signal intensity alteration was detrimental on knee symptoms and structural abnormalities. We hypothesise that an IPFP with normal qualities, rather than abnormal qualities, should be preserved during TKA. The aim of this study is to compare, over a 1-year period, the postoperative clinical outcomes of IPFP preservation versus resection after TKA in patients with normal or abnormal IPFP signal intensity alteration on MRI.
METHODS AND ANALYSIS


Three hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA will be recruited and identified as normal IPFP quality (signal intensity alteration score ≤1) or abnormal IPFP quality (signal intensity alteration score ≥2). Patients in each hospital will then be randomly allocated to IPFP resection group or preservation group. The primary outcomes are the summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation. Secondary endpoints will be included: KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray. Adverse events will be recorded. Intention-to-treat analyses will be used.
ETHICS AND DISSEMINATION


The study is approved by the local Medical Ethics Committee (Zhujiang Hospital Ethics Committee, reference number 2017-GJGBK-001) and will be conducted according to the principle of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard, and in compliance with the Medical Research Involving Human Subjects Act . Data will be published in peer-reviewed journals and presented at conferences, both nationally and internationally.
TRIAL REGISTRATION NUMBER


This trial was registered at Clinicaltrial.gov website on 19 October 2018 with identify number NCT03763448.",2020,The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure.,"['patients with normal or abnormal IPFP signal intensity alteration on MRI', 'patients with knee osteoarthritis (IPAKA', 'Three hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA']","['IPFP preservation versus resection after TKA', 'infrapatellar fat pad preservation versus resection', 'IPFP resection group or preservation group']","['normal IPFP quality (signal intensity alteration score ≤1) or abnormal IPFP quality (signal intensity alteration score ≥2', 'Adverse events', 'KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100\u2009mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100\u2009mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray', 'summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}]",360.0,0.202602,The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure.,"[{'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Arthritis Clinical and Research Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Zongsheng', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xifu', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'Department of Orthopaedic Surgery, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Zhengang', 'Initials': 'Z', 'LastName': 'Zha', 'Affiliation': 'Institute of Orthopaedic Diseases and Center for Joint Surgery and Sports Medicine, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedics, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, Sydney, New South Wales, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China Changhai.Ding@utas.edu.au.'}]",BMJ open,['10.1136/bmjopen-2020-043088']
1498,33099580,Total energy expenditure (TEE) of young adults from urban South India: revisiting their daily energy requirement.,"BACKGROUND/OBJECTIVES


Young Indian adults are at greater risk of overweight/obesity due to their high energy intake and sedentary lifestyle. Their energy requirement (ER) is based on their total energy expenditure (TEE) estimated from factorial method, which possibly overestimates their basal metabolic rate (BMR) and physical activity level (PAL). This study aimed to compare the accurately measured TEE with ER in young adults. Secondarily, to compare measured with predicted BMR and guideline PAL with that obtained from questionnaire and step counts.
SUBJECTS/METHODS


TEE was measured in 19 male adults (18-30 years), using the doubly labeled water technique, over 14 days. Indirect calorimetry was used to measure BMR, while the PAL was estimated by (a) the ratio of measured TEE and BMR, (b) step counts over 7 days measured using tri-axial accelerometers and (c) a physical activity questionnaire (PAQ).
RESULTS


The measured TEE (9.11 ± 1.30 MJ/d) was significantly lower than the ER using either the Indian (15.2%) or the FAO/WHO/UNU (11.9%, both p < 0.01) recommendations. The measured BMR (6.90 ± 0.65 MJ/d) was significantly lower than that predicted using the FAO/WHO/UNU equation (6.5%, p < 0.01) but not for the Indian equation. The estimated PAL from measured TEE and BMR (1.35 ± 0.18), and from accelerometers (1.33 ± 0.11) was significantly lower than PAL obtained from PAQ (1.53 ± 0.17) or the guideline of 1.53 for Indians.
CONCLUSIONS


The predicted BMR and PAL guideline value was higher than that measured in young Indian adults, resulting in a ~13% lower measured TEE. This emphasizes the need to revisit the guidelines for predicting ER for this population.",2020,"The measured BMR (6.90 ± 0.65 MJ/d) was significantly lower than that predicted using the FAO/WHO/UNU equation (6.5%, p < 0.01) but not for the Indian equation.","['Young Indian adults', 'young adults from urban South India', 'young adults', 'young Indian adults', '19 male adults (18-30 years']",[],"['BMR', 'Total energy expenditure (TEE', 'physical activity questionnaire (PAQ', 'basal metabolic rate (BMR) and physical activity level (PAL', 'BMR and PAL guideline value']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",19.0,0.0241346,"The measured BMR (6.90 ± 0.65 MJ/d) was significantly lower than that predicted using the FAO/WHO/UNU equation (6.5%, p < 0.01) but not for the Indian equation.","[{'ForeName': 'Srishti', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, A recognized research center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, A recognized research center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kuriyan', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, A recognized research center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India. rebecca@sjri.res.in.""}]",European journal of clinical nutrition,['10.1038/s41430-020-00790-5']
1499,33099648,Intravenous immunoglobulins as first-line treatment in idiopathic inflammatory myopathies: a pilot study.,"OBJECTIVES


We explored efficacy and safety of IVIg as first-line treatment in patients with an idiopathic inflammatory myopathy.
METHODS


In this investigator-initiated phase 2 open-label study, we included 20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9 months. Patients with IBM and prior use of immunosuppressants were excluded. The standard treatment regimen consisted of IVIg (Privigen) monotherapy for 9 weeks: a loading dose (2 g/kg body weight) and two subsequent maintenance doses (1 g/kg body weight) with a 3-week interval. The primary outcome was the number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score. Secondary outcomes included time to improvement, the number of patients requiring rescue medication and serious adverse events.
RESULTS


We included patients with DM (n = 9), immune-mediated necrotizing myopathy (n = 6), non-specific myositis/overlap myositis (n = 4) and anti-synthetase syndrome (n = 1). One patient was excluded from analyses because of minimal weakness resulting in a ceiling effect. Eight patients (8/19 = 42.0%; Clopper-Pearson 95% CI: 19.6, 64.6) had at least moderate improvement by 9 weeks. Of these, six reached improvement by 3 weeks. Seven patients required rescue medication due to insufficient efficacy and prematurely ended the study. Three serious adverse events occurred, of which one was pulmonary embolism.
CONCLUSION


First-line IVIg monotherapy led to at least moderate improvement in nearly half of patients with a fast clinical response in the majority of responders.
TRIAL REGISTRATION


Netherlands Trial Register identifier, NTR6160.",2020,"Three serious adverse events occurred, of which one was pulmonary embolism.
","['patients with DM (n\u2009=\u20099), immune-mediated necrotizing myopathy (n\u2009=\u20096), non-specific myositis/overlap myositis (n\u2009=\u20094) and anti-synthetase syndrome (n\u2009=\u20091', '9\u2009weeks', '20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9\u2009months', 'Patients with IBM and prior use of immunosuppressants were excluded', 'idiopathic inflammatory myopathies', 'patients with an idiopathic inflammatory myopathy']","['IVIg (Privigen', 'monotherapy', 'Intravenous immunoglobulins']","['time to improvement, the number of patients requiring rescue medication and serious adverse events', 'number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027121', 'cui_str': 'Myositis'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0023689', 'cui_str': 'Ligase'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0751356', 'cui_str': 'Idiopathic inflammatory myopathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C2342400', 'cui_str': 'Privigen'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0560137,"Three serious adverse events occurred, of which one was pulmonary embolism.
","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Brusse', 'Affiliation': 'Department of Neurology, Erasmus UMC, Rotterdam.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Hoogendijk', 'Affiliation': 'Department of Neurology, Brain Centre Rudolf Magnus, UMC Utrecht, Utrecht.'}, {'ForeName': 'Christiaan G J', 'Initials': 'CGJ', 'LastName': 'Saris', 'Affiliation': 'Department of Neurology, Radboud UMC, Donders Institute for Brain Cognition and Behaviour, Nijmegen.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Raaphorst', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'De Haan', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Aronica', 'Affiliation': 'Department of (Neuro)Pathology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Visser', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}, {'ForeName': 'Anneke J', 'Initials': 'AJ', 'LastName': 'van der Kooi', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa459']
1500,33099665,Impact of Mesh and Fixation on Chronic Inguinal Pain in Lichtenstein Hernia Repair: 5-Year Outcomes from the Finn Mesh Study.,"OBJECTIVE


To find out the mesh fixation technique that minimises chronic pain in Lichtenstein hernioplasty. Mesh fixation may affect chronic pain and recurrence after inguinal hernia surgery, but long-term results of comparative trials are lacking.
METHODS


Lichtenstein hernioplasty was performed under local anaesthesia on 625 patients in day care units. The patients were randomised to receive either a cyanoacrylate glue (n = 216), self-gripping mesh (n = 202) or non-absorbable 3-0 polypropylene sutures (n = 216) for the fixation of mesh. A standardised telephone interview or postal questionnaire was conducted 5 years after the index operation. The patients with complaints suggesting recurrence or chronic pain (visual analogue scale ≥ 3, 0-10) were examined clinically. The rate of occasional pain, chronic severe pain, recurrence, re-operations, daily use of analgesics, overall patient satisfaction and sensation of a foreign object were recorded.
RESULTS


A total of 82% of patients (n = 514) completed the 5-year audit including 177, 167 and 170 patients in the glue, self-fixation and suture groups, respectively. There were no significant differences in the incidence of pain (7-8%), operated recurrences (2-4%), overall re-operations (4-5%), need for analgesics (1-2%), patient's satisfaction (93-97%) or in the feeling of a foreign object (11-18%) between the study groups.
CONCLUSION


The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia. Less penetrating fixation (glue or self-gripping mesh) is a safe option for the fixation of mesh in Lichtenstein hernia repair.",2020,"The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia.","['625 patients in day care units', 'patients with complaints suggesting recurrence or chronic pain (visual analogue scale\u2009≥\u20093, 0-10', 'Lichtenstein hernioplasty', 'Lichtenstein Hernia Repair', 'A total of 82% of patients (n\u2009=\u2009514) completed the 5-year audit including 177, 167 and 170 patients in the glue, self-fixation and suture groups, respectively']","['Lichtenstein hernioplasty', 'self-gripping mesh (n\u2009=\u2009202) or non-absorbable 3-0 polypropylene sutures', 'mesh fixation technique', 'Mesh fixation', 'penetrating fixation (glue or self-gripping mesh', 'Mesh and Fixation', 'cyanoacrylate glue']","['operated recurrences', 'incidence of pain', 'Chronic Inguinal Pain', 'rate of occasional pain, chronic severe pain, recurrence, re-operations, daily use of analgesics, overall patient satisfaction and sensation of a foreign object', ""patient's satisfaction"", 'overall re-operations', 'chronic pain and recurrence', 'overall long-term outcome, pain or recurrence of hernia']","[{'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0491217', 'cui_str': 'Polypropylene suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016542', 'cui_str': 'Foreign body'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",625.0,0.140513,"The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'North-Karelia Central Hospital, Joensuu, Finland. markku.matikainen@siunsote.fi.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vironen', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kössi', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hulmi', 'Affiliation': 'North-Karelia Central Hospital, Joensuu, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hertsi', 'Affiliation': 'Savonlinna Central Hospital, Savonlinna, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}]",World journal of surgery,['10.1007/s00268-020-05835-1']
1501,33099742,Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus.,"INTRODUCTION


The aim of this analysis was to evaluate the efficacy of lobeglitazone on albuminuria at 24 weeks of follow-up in patients with type 2 diabetes mellitus (T2DM) compared with pioglitazone using data from a randomized, double-blinded phase III trial.
METHODS


In the phase III trial, patients who were inadequately controlled with metformin received 0.5 mg of lobeglitazone or 15 mg of pioglitazone for 24 weeks. Post hoc, exploratory analysis was used to investigate mean changes from baseline in the urine albumin-creatinine ratio (UACR) between the lobeglitazone (N = 104) and pioglitazone (N = 101) treatment groups.
RESULTS


After 24 weeks of treatment, UACR was slightly decreased in the lobeglitazone group (- 4.3 mg/g creatinine [Cr]) compared to baseline and slightly increased in the pioglitazone group (5.2 mg/g Cr), with no change in the estimated glomerular filtration rate in either group; this difference was not statistically significant (P = 0.476). The incidence of new-onset microalbuminuria (2.4%) and the progression of albuminuria by > 1 stage (2.9%) in the lobeglitazone group were lower than the respective values in the pioglitazone group (6.8 and 6.1%, respectively). Of the patients in the lobeglitazone group, 50% exhibited regression to normoalbuminuria, compared to 39.3% of the patients in the pioglitazone. In subjects in the lobeglitazone group with micro- and macroalbuminuria, UACR tended to be more decreased and HbA1c was more reduced compared to those with normoalbuminuria (P = 0.014).
CONCLUSION


Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01106131.",2020,"Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects.
","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Lobeglitazone Versus Pioglitazone', 'metformin', 'pioglitazone', 'Lobeglitazone', 'lobeglitazone']","['progression of albuminuria', 'urine albumin-creatinine ratio (UACR', 'UACR', 'glomerular filtration rate', 'incidence of new-onset microalbuminuria', 'albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}]",,0.195908,"Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects.
","[{'ForeName': 'Kyung-Soo', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Sangmo', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Republic of Korea.'}, {'ForeName': 'Hong-Yup', 'Initials': 'HY', 'LastName': 'Ahn', 'Affiliation': 'Department of Statistics, Dongguk University-Seoul, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. cydoctor@chol.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00948-1']
1502,33099752,Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B.,"BACKGROUND


Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8-14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B.
METHODS


Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24).
RESULTS


The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log 10  S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%).
CONCLUSION


In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B.",2020,The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups.,"['Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status', 'patients with chronic hepatitis B', 'chronic hepatitis B']","['Ropeginterferon alfa-2b', 'q2w ropeginterferon alfa-2b 350\xa0μg (group 1), q2w 450\xa0μg (group 2) or q1w PEG-IFN alfa-2a 180\xa0μg', 'interferon alfa-2a', '48-week treatment (TW48) and 24-week post-treatment follow-up (FW24']","['Cumulative HBeAg seroconversion rate', 'ALT elevation', 'safety and efficacy', 'rate of HBV DNA', 'incidence of rash']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}]","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.108808,The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups.,"[{'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Liver Center, Cathay General Hospital Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chao-Wei', 'Initials': 'CW', 'LastName': 'Hsu', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Nan', 'Initials': 'SN', 'LastName': 'Lu', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chia-Yi Chang Gung Memorial Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Section, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Chien', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Ching-Sheng', 'Initials': 'CS', 'LastName': 'Hsu', 'Affiliation': 'Liver Diseases Research Center, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jer', 'Initials': 'SJ', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital Yun-Lin Branch, Yunlin, Taiwan.'}, {'ForeName': 'Hsueh-Chou', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'PharmaEssentia Corp, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chiao', 'Initials': 'KC', 'LastName': 'Tseng', 'Affiliation': 'PharmaEssentia Corp, Taipei, Taiwan.'}, {'ForeName': 'Pei-Jer', 'Initials': 'PJ', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, No. 7, Chung-Shan South Rd., Taipei, Taiwan. peijerchen@ntu.edu.tw.'}]",Hepatology international,['10.1007/s12072-020-10098-y']
1503,33099812,High-intensity focused ultrasound ablation combined with transcatheter arterial chemoembolization improves long-term efficacy and prognosis of primary liver cancer.,"BACKGROUND


To investigate the clinical efficacy of high-intensity focused ultrasound (HIFU) combined with transcatheter arterial chemoembolization (TACE) in the treatment of primary liver cancer (PLC) and its effect on the prognosis of patients.
METHODS


A total of 132 patients with PLC admitted to our hospital were selected for the study, among whom 68 patients received TACE combined with HIUF and were assigned to the observation group (OG), whereas the remaining 54 patients were treated with TACE alone and were assigned to the control group (CG). The factors influencing the patients' prognosis were also evaluated by multivariate analysis.
RESULTS


The total effective rate of the OG was 83.82%, which was significantly higher than that of 55.56% of the CG (P < .05). No significant difference was found in incidence of adverse reactions between the two groups (P > .05). After treatment, the increases of CD3+, CD4+, CD4+/CD8+, and NK cells in the OG were more significant than those in the CG (P < .05). However, the decrease of CD8+ cells was more significant in the OG than that in the CG (P < .05). The 3-year survival rate of patients in the OG was 61.76%, which was significantly higher than that of 40.74% in the CG (P < .05).
CONCLUSION


The application of TACE combined with HIFU is effective in treating PLC, which can prolong the life expectancy and improve the prognosis of patients with PLC without increasing the incidence of adverse reactions.",2020,No significant difference was found in incidence of adverse reactions between the two groups (P > .05).,"['primary liver cancer (PLC', '132 patients with PLC admitted to our hospital were selected for the study, among whom 68 patients received', 'primary liver cancer']","['TACE alone', 'ultrasound ablation combined with transcatheter arterial chemoembolization', 'high-intensity focused ultrasound (HIFU) combined with transcatheter arterial chemoembolization (TACE', 'TACE combined with HIUF', 'CG (P', 'TACE combined with HIFU']","['CD3+, CD4+, CD4+/CD8+, and NK cells in the OG', '3-year survival rate', 'incidence of adverse reactions', 'total effective rate of the OG', 'CD8+\xa0cells']","[{'cui': 'C0024620', 'cui_str': 'Primary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}]",132.0,0.0242578,No significant difference was found in incidence of adverse reactions between the two groups (P > .05).,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Interventional Vascular Surgery, Affiliated Hospital of Hebei University, Baoding, Hebei, China.'}, {'ForeName': 'Pengyan', 'Initials': 'P', 'LastName': 'Shang', 'Affiliation': 'Baoding maternal and Child Health Hospital, Baoding, Hebei, China.'}, {'ForeName': 'Jiangtao', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Interventional Vascular Surgery, Affiliated Hospital of Hebei University, Baoding, Hebei, China.'}, {'ForeName': 'Shanfeng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Interventional Vascular Surgery, Affiliated Hospital of Hebei University, Baoding, Hebei, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Interventional Vascular Surgery, Affiliated Hospital of Hebei University, Baoding, Hebei, China.'}]",Journal of clinical laboratory analysis,['10.1002/jcla.23633']
1504,33099836,"The early and late efficacy of single-pass fractional carbondioxide laser, fractional radiofrequency and their combination in acne scars: A prospective, split-face, single-blinded, controlled clinical study.","OBJECTIVES


We investigated the effectiveness of fractional carbon dioxide laser (FCO2) vs. fractional radiofrequency (FRF) and FCO2 vs. FRF plus FCO2 combination in the treatment of acne scars.
MATERIALS AND METHODS


Twenty-seven patients were included. Scar severity was scored with ""Echelle d'évaluation clinique des cicatrices d'acné"" (ECCA) by a dermatologist blinded to treatment. FCO2 and FRF were administered to the right and left halves of the patients' faces, respectively, at the first 3 visits, once a month. At the 4th visit, FCO2 was administered to both sides. Last evaluation was performed six months after the last treatment.
RESULTS


Mean ECCA scores for both face halves decreased gradually at each visit compared to Visit-1; however, the effect size of decrease was higher in the right half of the face and in terms of gender differences was higher in women for both sides that the difference was more pronounced for the FRF side. There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05). Side effects were similar; but lasted longer in the FCO2 side.
CONCLUSION


Both FCO2 and FRF are effective treatment methods in the treatment of atrophic acne scars. Combining FCO2 to FRF improves patient satisfaction. FRF may achieve better results in women compared to men. To our knowledge the study is unique prospective, controlled clinical study comparing the efficacy of FCO2 and FRF plus FCO2 combination treatments. This article is protected by copyright. All rights reserved.",2020,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"['atrophic acne scars', 'acne scars', 'Twenty-seven patients were included']","['single-pass fractional carbondioxide laser, fractional radiofrequency and their combination', 'FCO2 and FRF', 'FRF', 'fractional carbon dioxide laser (FCO2) vs. fractional radiofrequency (FRF) and FCO2 vs. FRF plus FCO2 combination', 'FCO2 and FRF plus FCO2']","['Mean ECCA scores', 'Scar severity', 'Side effects', 'mean VAS patient satisfaction scores']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",27.0,0.0323366,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Kaçar', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Dursun', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akbay', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Şule', 'Initials': 'Ş', 'LastName': 'GökŞin', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}]",Dermatologic therapy,['10.1111/dth.14444']
1505,33099848,Comparison of insulin degludec (IDeg)/insulin Aspart (IAsp) co-formulation therapy twice-daily with free combination of GLP-1 receptor agonist liraglutide plus insulin degludec in Tochigi: IDEAL Trial.,"AIM


We compared the efficacy and safety of insulin degludec/insulin aspart co-formulation (IDegAsp) twice-daily to a free combination of basal insulin degludec and GLP-1 receptor agonist liraglutide (IDeg+Lira) once-daily for patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs.
SUBJECTS AND METHODS


Eligible patients were randomly allocated at a 1:1 ratio to receive either the once-daily dual-injection of IDeg+Lira (n=24) or twice-daily single-injection of IDegAsp (n=28). The primary endpoints were: HbA1c changes over 52 weeks of treatment and the percentage of participants achieving HbA1c<7.0% at week 52.
RESULTS


After 52 weeks, HbA1c decreased by 0.3% in the IDegAsp group and by 0.7% in the IDeg+Lira group. The HbA1c reduction was greater in the IDeg+Lira group than in the IDegAsp group. 19% of patients on IDegAsp versus 40% on IDeg+Lira achieved HbA1c<7.0%. Pre-breakfast and pre-dinner blood glucose at 52 weeks were significantly lower in the IDeg+Lira group than in the IDegAsp group. The reduction in body mass index (BMI) was greater in the IDeg+Lira group than in the IDegAsp group throughout the study period. The confirmed hypoglycemia rates were 1.32 and 0.69 per patient/year of exposure to IDegAsp and IDeg+Lira, respectively.
CONCLUSIONS


In patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs, treatment with the once-daily dual-injection of IDeg+Lira compared to the twice-daily single-injection of IDegAsp showed no significant difference in glycemic control but statistically superior weight loss.",2020,Pre-breakfast and pre-dinner blood glucose at 52 weeks were significantly lower in the IDeg+Lira group than in the IDegAsp group.,"['Eligible patients', 'patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs']","['GLP-1 receptor agonist liraglutide (IDeg+Lira', 'IDeg+Lira (n=24) or twice-daily single-injection of IDegAsp', 'insulin degludec (IDeg)/insulin Aspart (IAsp) co-formulation therapy', 'IDeg+Lira', 'insulin degludec/insulin aspart co-formulation (IDegAsp']","['hypoglycemia rates', 'glycemic control', 'body mass index (BMI', 'Pre-breakfast and pre-dinner blood glucose', 'HbA1c changes', 'HbA1c reduction', 'HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0288439,Pre-breakfast and pre-dinner blood glucose at 52 weeks were significantly lower in the IDeg+Lira group than in the IDegAsp group.,"[{'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Aso', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Mibu, Tochigi, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Takada', 'Affiliation': 'Takada Clinic, Tochigi, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tomotsune', 'Affiliation': 'Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Nagasaki Hospital, Ashikaga, Tochigi, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Matsumura', 'Affiliation': 'Kamitsuga General Hospital, Kanuma, Tochigi, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Jojima', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Mibu, Tochigi, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'NHO Utsunomiya National Hospital, Utsunomiya, Tochigi, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Fujita', 'Affiliation': 'Fujita Medical Clinic, Utsunomiya, Tochigi, Japan.'}, {'ForeName': 'Hisamoto', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Green Clinic, Mibu, Tochigi, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Murano', 'Affiliation': 'Tochigi Medical Center Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Usui', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Mibu, Tochigi, Japan.'}]",International journal of clinical practice,['10.1111/ijcp.13734']
1506,33099850,Minimising Immunisation Pain of childhood vaccines: The MIP pilot study.,"AIM


Pain associated with immunisations can result in distress and/or anxiety for children and parents. We assessed the feasibility and acceptability of two novel devices; Coolsense (cold) and Buzzy (vibration ± cooling pads) versus standard care to minimise pain during immunisations. We also evaluated compliance to the devices and parent's perception of the effectiveness of the devices/standard care for minimising pain during immunisation.
DESIGN


Open label, pilot, randomised controlled trial (RCT).
METHODS


Forty children aged 3.5 to 6 years attending an Immunisation Centre at The Royal Children's Hospital in Melbourne, Australia, were randomised (1:1:1:1) into four groups: (i) Coolsense plus standard care; (ii) Buzzy with cold plus standard care; (iii) Buzzy without cold plus standard care; and (iv) Standard care alone (distraction with bubbles).
RESULTS AND ANALYSIS


Recruitment was completed in 12 days. Seventy percent were compliant with Buzzy (±cold), 82% with Coolsense, and 60% with standard care. Buzzy (with cold) was identified as effective by 70% of parents, Coolsense by 64%, Buzzy without cold by 50% and standard care by 60%.
CONCLUSIONS


This pilot study demonstrated feasibility. A larger RCT is needed to provide definitive evidence to inform best practice for minimising immunisation pain in young children.",2020,"Buzzy (with cold) was identified as effective by 70% of parents, Coolsense by 64%, Buzzy without cold by 50% and standard care by 60%.
","['childhood vaccines', 'children and parents', 'Seventy percent were compliant with Buzzy (±cold), 82% with Coolsense, and 60% with standard care', ""Forty children aged 3.5 to 6\u2009years attending an Immunisation Centre at The Royal Children's Hospital in Melbourne, Australia"", 'young children']","['Standard care alone (distraction with bubbles', ' Buzzy without cold plus standard care; and (iv', 'Coolsense plus standard care; (ii) Buzzy with cold plus standard care; (iii', 'Buzzy (with cold', 'two novel devices; Coolsense (cold) and Buzzy (vibration ± cooling pads']",['distress and/or anxiety'],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",40.0,0.124413,"Buzzy (with cold) was identified as effective by 70% of parents, Coolsense by 64%, Buzzy without cold by 50% and standard care by 60%.
","[{'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Jenkins', 'Affiliation': ""Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Elia', 'Affiliation': ""Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Perrett', 'Affiliation': ""Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}]",Journal of paediatrics and child health,['10.1111/jpc.15229']
1507,33099851,Evaluation of hirsutism and hormonal parameters in acne vulgaris patients treated with isotretinoin.,"BACKGROUND


Although the effect of isotretinoin use on hormonal changes in acne pathogenesis is not fully known, there are limited studies on its effects on the development of hirsutism. In this study, it was aimed to evaluate the effect of isotretinoin use on hirsutism and hormonal parameters in patients with acne vulgaris.
METHODS


In this study, 30 female acne patients and 30 healthy females were evaluated prospectively. Menstrual irregularity, LH, FSH, Prolactin, Progesterone, 17-OH Progesterone, Estradiol, Total testosterone, DHEA-S, Insulin, Glucose, TSH levels, Ferriman-Gallwey (FG) score and ultrasonography (USG) findings of control group and patient group were recorded.
RESULTS


Pre-treatment progesterone (p = 0.007) and estradiol (p = 0.001) levels of the patients were statistically lower than the control group. In the patient group, menstrual irregularity (p <001) and FG hirsutism score at the 3rd month of treatment were significantly higher than before treatment. In 10% of the patients, there were abnormal findings on pelvic USG in the third month of treatment.
CONCLUSION


In our study, it could not be revealed that isotretinoin has a significant effect on pituitary, adrenal hormones and insulin resistance. We found that three months of isotretinoin treatment caused an increase in menstrual irregularity and FG hirsutism score.",2020,Pre-treatment progesterone (p = 0.007) and estradiol (p = 0.001) levels of the patients were statistically lower than the control group.,"['acne vulgaris patients treated with', 'patients with acne vulgaris', '30 female acne patients and 30 healthy females']",['isotretinoin'],"['FG hirsutism score', 'pituitary, adrenal hormones and insulin resistance', 'pelvic USG', 'menstrual irregularity', 'menstrual irregularity and FG hirsutism score', 'hirsutism and hormonal parameters', 'Menstrual irregularity, LH, FSH, Prolactin, Progesterone, 17-OH Progesterone, Estradiol, Total testosterone, DHEA-S, Insulin, Glucose, TSH levels, Ferriman-Gallwey (FG) score and ultrasonography (USG']","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022265', 'cui_str': 'Isotretinoin'}]","[{'cui': 'C0578772', 'cui_str': 'Hirsutism score'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0156404', 'cui_str': 'Irregular periods'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0211677,Pre-treatment progesterone (p = 0.007) and estradiol (p = 0.001) levels of the patients were statistically lower than the control group.,"[{'ForeName': 'Rojda', 'Initials': 'R', 'LastName': 'Aktar', 'Affiliation': 'Department of Dermatology, Kahta State Hospital, Adiyaman, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Gunes Bılgılı', 'Affiliation': 'Department of Dermatology, Van Yuzuncu Yil University, Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Ibrahım Halıl', 'Initials': 'IH', 'LastName': 'Yavuz', 'Affiliation': 'Department of Dermatology, Van Yuzuncu Yil University, Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Goknur', 'Initials': 'G', 'LastName': 'Ozaydın Yavuz', 'Affiliation': 'Department of Dermatology, Van Yuzuncu Yil University, Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Siraç', 'Initials': 'S', 'LastName': 'Aktar', 'Affiliation': 'Department of Dermatology, Bismil State Hospital, Diyarbakir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Öztürk', 'Affiliation': 'Department of Dermatology, Health Sciences Universty, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ayşe Serap', 'Initials': 'AS', 'LastName': 'Karadağ', 'Affiliation': 'Department of Dermatology, Istanbul Medeniyet University, Faculty of Medicine, Goztepe Training and Research Hospital, Istanbul, Turkey.'}]",International journal of clinical practice,['10.1111/ijcp.13791']
1508,33099855,Erector spinae plane block vs. Nonsteroidal anti-inflammatory drugs for severe renal colic pain: a pilot clinical feasibility study.,"AIM


Ultrasound-guided plane blocks are increasingly used in the multi-modal analgesic concept for reducing opioid consumption. The present study was conducted to compare the analgesic effect of intravenous nonsteroidal anti-inflammatory drugs (NSAIDs) and erector spinae plane (ESP) block in renal colic patients.
METHODS


In this prospective randomized study, 40 patients with renal colic pain were randomly assigned to into two groups; Group NSAID (n=20) received an intravenous infusion of 50 mg of dexketoprofen trometamol, Group ESP (n=20) received ultrasound-guided erector spinae plane block with 30 ml 0.25% bupivacaine at the T8 level. The pain severity of patients was assessed using the visual analog scale (VAS) at baseline, 5., 15., 30., 45. and 60. minutes after intervention. Opioid consumption, patient satisfaction and side effects were recorded.
RESULTS


In the ESP group, the VAS scores were significantly lower than the NSAID group at 5., 15., 30., 45. and 60. minutes after the procedure (P<0.001). Opioid consumption was significantly higher in the NSAID group compared with the ESP group (10/20 vs. 0/20, respectively; p<0.001). Patient satisfaction was significantly higher in the ESP group (p<0.001).
CONCLUSIONS


ESP block can be an alternative, efficient, and safe method for the relief of acute renal colic pain.",2020,"Patient satisfaction was significantly higher in the ESP group (p<0.001).
","['severe renal colic pain', '40 patients with renal colic pain', 'renal colic patients']","['Erector spinae plane block vs. Nonsteroidal anti-inflammatory drugs', 'intravenous infusion of 50 mg of dexketoprofen trometamol, Group ESP', 'intravenous nonsteroidal anti-inflammatory drugs (NSAIDs) and erector spinae plane (ESP) block', 'ESP', 'NSAID', 'Ultrasound-guided plane blocks', 'ultrasound-guided erector spinae plane block with 30 ml 0.25% bupivacaine']","['Opioid consumption', 'Patient satisfaction', 'VAS scores', 'visual analog scale (VAS', 'Opioid consumption, patient satisfaction and side effects', 'pain severity']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0765538', 'cui_str': 'Dexketoprofen tromethamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",40.0,0.0834944,"Patient satisfaction was significantly higher in the ESP group (p<0.001).
","[{'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Tekin', 'Affiliation': 'Department of Emergency Medicine, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Oral Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Karagoz', 'Affiliation': 'Department of Emergency Medicine, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Omerul Faruk', 'Initials': 'OF', 'LastName': 'Aydin', 'Affiliation': 'Department of Emergency Medicine, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Ozkaya', 'Affiliation': 'Department of Urology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",International journal of clinical practice,['10.1111/ijcp.13789']
1509,33103776,Effect of progressive muscle relaxation exercise on clinical stress and burnout in student nurse interns.,"PURPOSE


To determine the effects of progressive muscle relaxation exercise (PMRE) on clinical stress and burnout in student nurse interns.
DESIGN AND METHODS


This is a randomized controlled trial. Interns were divided into control group (CG; n = 78) or experimental group (EG; n = 67) randomly. PMRE was performed by students in the EG. Personal information form, Burnout Measure Short Version (BMS) and Physio-Psycho-Social Response Scale (PPSRS) for nursing students were administered to both groups in the first and last meeting.
FINDINGS


There was a significant difference in posttest scores between groups; EG posttest scores on the BMS, on the PPSRS, and subscales were lower than those of the CG.
PRACTICE IMPLICATIONS


PMRE training ameliorates burnout and PPSRs to stress during clinical practice in nursing students.",2020,"There was a significant difference in posttest scores between groups; EG posttest scores on the BMS, on the PPSRS, and subscales were lower than those of the CG.
","['nursing students', 'student nurse interns']","['progressive muscle relaxation exercise (PMRE', 'PMRE training', 'PMRE', 'progressive muscle relaxation exercise']","['Personal information form, Burnout Measure Short Version (BMS) and Physio-Psycho-Social Response Scale (PPSRS', 'PPSRS, and subscales']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0120005,"There was a significant difference in posttest scores between groups; EG posttest scores on the BMS, on the PPSRS, and subscales were lower than those of the CG.
","[{'ForeName': 'Sıdıka', 'Initials': 'S', 'LastName': 'Pelit-Aksu', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Özkan-Şat', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Yaman-Sözbi R', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Şentürk-Erenel', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12662']
1510,33103789,TACO-BEL-3: a feasibility study and a retrospective audit of diuretics for patients receiving blood transfusion at ten hospitals.,"BACKGROUND AND OBJECTIVES


Transfusion-associated circulatory overload (TACO) is the leading cause of transfusion-related morbidity and mortality. A recently completed pilot trial randomized patients to pre-transfusion furosemide versus placebo but had a slower than expected enrollment rate. We sought to determine whether the lack of recruitment was due to a paucity of eligible patients or excessively restrictive eligibility criteria.
MATERIALS AND METHODS


At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions. The age threshold was decreased from 65 to 50 years. The first 10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria. The incidence of TACO and furosemide use was also recorded.
RESULTS


At the 10 sites, 11 969 red cell units were transfused over 1 month and 1356 met the inclusion criteria. Of the 100 charts reviewed, 60 (60%) had no exclusion criteria. Active bleeding was the most common reason for ineligibility. There were 813 eligible transfusion episodes. Of the eligible patients, 17 (28·3%) had evidence of congestive heart failure, and furosemide was prescribed in 24 (40%). Despite the use of a lower age threshold, three cases of TACO were detected with an incidence of 3%.
CONCLUSION


A large number of transfusion episodes met eligibility criteria. With a 3% incidence of TACO, 50% decrease through the use pre-transfusion furosemide and a target consent rate of 30%, a definitive trial of approximately 3000 patients could be completed within 1 year.",2020,"Of the 100 charts reviewed, 60 (60%) had no exclusion criteria.","['patients receiving blood transfusion at ten hospitals', 'At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions', 'Of the 100 charts reviewed, 60 (60%) had no exclusion criteria', '10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria', 'eligible patients or excessively restrictive eligibility criteria', '813 eligible transfusion episodes']","['transfusion furosemide versus placebo', 'diuretics', 'TACO-BEL-3']","['congestive heart failure', 'Active bleeding', 'incidence of TACO and furosemide use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005770', 'cui_str': 'Blood Banks'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",11969.0,0.156831,"Of the 100 charts reviewed, 60 (60%) had no exclusion criteria.","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Khandelwal', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cserti-Gazdewich', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Muntadhar', 'Initials': 'M', 'LastName': 'Al Moosawi', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Armali', 'Affiliation': 'Education and Safety in Transfusion (QUEST) Research Program, University of Toronto Quality in Utilization, Toronto, ON, Canada.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Hamilton General Hospital, Hamilton, ON, Canada.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Dallas', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Lieberman', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Pavenski', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rioux-Massé', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, PQ, Canada.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Shehata', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Shih', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pendergrast', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}]",Vox sanguinis,['10.1111/vox.12994']
1511,33103819,A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT.,"INTRODUCTION


Counteracting impaired brain glucose metabolism with ketones may improve cognition in mild cognitive impairment (MCI).
METHODS


Cognition, plasma ketone response, and metabolic profile were assessed before and 6 months after supplementation with a ketogenic drink containing medium chain triglyceride (ketogenic medium chain triglyceride [kMCT]; 15 g twice/day; n = 39) or placebo (n = 44).
RESULTS


Free and cued recall (Trial 1; P = .047), verbal fluency (categories; P = .024), Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates). Some cognitive outcomes also correlated positively with plasma ketones. Plasma metabolic profile and ketone response were unchanged.
CONCLUSIONS


This kMCT drink improved cognitive outcomes in MCI, at least in part by increasing blood ketone level. These data support further assessment of MCI progression to Alzheimer's disease.",2020,"Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates).","['mild cognitive impairment', 'mild cognitive impairment (MCI']","['ketogenic drink containing medium chain triglyceride (ketogenic medium chain triglyceride [kMCT', 'ketogenic drink', 'placebo', 'kMCT']","['Plasma metabolic profile and ketone response', 'cognitive outcomes', 'verbal fluency', 'Cognition, plasma ketone response, and metabolic profile', 'plasma ketones', 'blood ketone level', 'Free and cued recall']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0919339,"Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates).","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Fortier', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Christian-Alexandre', 'Initials': 'CA', 'LastName': 'Castellano', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'St-Pierre', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Langlois', 'Affiliation': ""CIUSSS de l'Éstrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Morin', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bocti', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Fulop', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Godin', 'Affiliation': 'Institute of Food Safety and Analytical Sciences, Nestlé Research, Lausanne, Switzerland.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Delannoy', 'Affiliation': 'Nestlé Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cuenoud', 'Affiliation': 'Nestlé Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Cunnane', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12206']
1512,33103916,"Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial.","OBJECTIVE


To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions.
DESIGN


Multicentre, prospective, randomised, open-label trial.
SETTING


Twenty-three hospitals.
SUBJECTS


In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group.
INTERVENTION


Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device.
MAIN MEASURES


The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events.
RESULTS


Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
CONCLUSION


The improvement in gait ability and body functions were equivalent with or without the use of the device.",2020,"No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
","['Twenty-three hospitals', 'Fifty-six experimental and 59 control group participants, with an average age of 59\u2009years (SD 12) completed the trial', '119 stroke patients with foot drop', 'chronic stroke patients with hemiplegia (PLEASURE']","['480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device', 'gait training', 'peroneal nerve functional electrical stimulation']","['gait ability and body functions', 'change in the six-minute walk test (6MWT', '10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events', '6MWT distance changes (m']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085684', 'cui_str': 'Foot-drop'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",119.0,0.0855705,"No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment ( P  = 0.048).
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hachisuka', 'Affiliation': 'Kyushu Rosai Byoin Moji Medical Center, Japan Organization of Occupational Health and Safety, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Hyogo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}]",Clinical rehabilitation,['10.1177/0269215520966702']
1513,33103925,Effectiveness of brief schema group therapy for borderline personality disorder symptoms: a randomized pilot study.,"BACKGROUND AND OBJECTIVES


Schema group therapy is a potentially cost-effective treatment for borderline personality disorder (BPD). We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
METHODS


Altogether 42 psychiatric outpatients diagnosed with BPD were randomized 2:1 to a 20-session weekly schema group therapy plus treatment as usual (TAU) ( n  = 28) vs. a control group with TAU alone ( n  = 14). The primary outcome was decline of BPD symptoms in the short Borderline Symptom List (BSL-23) score. Secondary outcomes were decline in symptoms of anxiety, depression, alcohol use, and improvement in functioning and schema modes. Two external experts evaluated validity of the intervention based on videotaped sessions.
RESULTS


Overall, 23 schema group therapy patients (82%) and 12 controls (86%) completed their treatment. Treatment validity good or very good. However, no significant differences emerged in the primary outcome mean BSL-23 decline (6.95 [SE 5.91] in group schema therapy vs. 12.55 [4.85] in TAU) or in any of the secondary outcome measures.
LIMITATIONS


Despite randomization, the TAU subgroup had non-significantly higher baseline scores in most measures. Small sample size predisposing to type II errors; reliance on self-reported outcomes.
CONCLUSIONS


Schema group therapy was feasible for psychiatric outpatients with BPD. However, in this small pilot study we did not find it more effective than TAU. Effectiveness of this short intervention remains open.",2020,"We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
","['borderline personality disorder symptoms', 'Altogether 42 psychiatric outpatients diagnosed with BPD', 'psychiatric BPD outpatients', 'psychiatric outpatients with BPD', 'borderline personality disorder (BPD']","['20-session schema group therapy without individual therapy', 'control group with TAU alone', '20-session weekly schema group therapy plus treatment as usual (TAU', 'brief schema group therapy']","['decline in symptoms of anxiety, depression, alcohol use, and improvement in functioning and schema modes', 'decline of BPD symptoms in the short Borderline Symptom List (BSL-23) score', 'mean BSL-23 decline']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1443933', 'cui_str': 'Laboratory biosafety level'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",2.0,0.0816193,"We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
","[{'ForeName': 'Hanna-Mari', 'Initials': 'HM', 'LastName': 'Hilden', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Rosenström', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Karila', 'Affiliation': 'KL Institute, Helsinki, Finland.'}, {'ForeName': 'Aila', 'Initials': 'A', 'LastName': 'Elokorpi', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Torpo', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ritva', 'Initials': 'R', 'LastName': 'Arajärvi', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Isometsä', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1826050']
1514,33103931,"The safety of medications used to treat peripheral neuropathic pain, part 2 (opioids, cannabinoids and other drugs): review of double-blind, placebo-controlled, randomized clinical trials.","INTRODUCTION


Peripheral neuropathic pain is a highly disabling condition for patients and a challenge for physicians. Although many drugs have been assessed in scientific studies, few have demonstrated clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raises the question of the benefit-risk ratio when used in patients experiencing peripheral neuropathies.
AREAS COVERED


We conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat peripheral neuropathic pain. This second review was focused on opioids, cannabinoids, and other medications. The aim was to provide an overview of the treatment-emergent adverse events (TEAEs) (≥10%) and the serious adverse effects described in clinical trials.
EXPERT OPINION


Opioids and cannabinoids had significantly more TEAEs than placebos. Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects. The results for NMDA antagonists were inconclusive since no safety report was available. Less than half of the studies included presented a good description of adverse effects that included a statistical comparison versus a placebo group. Major methodological improvements must be made to ameliorate the assessment of medication safety in future clinical trials.",2020,"Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects.",['patients experiencing peripheral neuropathies'],"['placebo', 'capsaicin, lidocaine, botulinum toxin']",['adverse effects'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.438243,"Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects.","[{'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Cuménal', 'Affiliation': 'Université Clermont Auvergne , INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Selvy', 'Affiliation': 'Université Clermont Auvergne , CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kerckhove', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Institut Analgesia , Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Célian', 'Initials': 'C', 'LastName': 'Bertin', 'Affiliation': 'Université Clermont Auvergne , CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Morez', 'Affiliation': 'Université Clermont Auvergne , INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Courteix', 'Affiliation': 'Université Clermont Auvergne , INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Busserolles', 'Affiliation': 'Université Clermont Auvergne , INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balayssac', 'Affiliation': 'Université Clermont Auvergne , CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Clermont-Ferrand, F-63000 Clermont-Ferrand, France.'}]",Expert opinion on drug safety,['10.1080/14740338.2021.1842871']
1515,33103938,A Palliative Care Intervention for Patients on Phase 1 Studies.,"Background:  Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns.  Objective:  To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group.  Design:  This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects ( n  = 479) were followed for 24 weeks, with 12 weeks as the primary outcome.  Setting:  Two Comprehensive Cancer Centers in the United States.  Subjects:  A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial.  Measurements:  Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit).  Results:  PCI subjects showed improved Psychological Distress (-0.47,  p  = 0.015) and Emotional Well-Being (0.81,  p  = 0.045), with differences on variables of QOL and distress between sites. High rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39.0%), and hospice enrollment (30.7%), despite a median survival in both groups of 10.1 months from initiating a Phase 1 study.  Conclusions:  A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598.",2020,"Well-Being (0.81,  p  = 0.045), with differences on variables of QOL and distress between sites.","['Subjects:  A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial', 'patients participating in Phase 1 trials', 'patients with solid tumors enrolled in Phase']","['PCI', 'Palliative Care Intervention (PCI', 'Palliative Care Intervention']","['psychological distress, QOL, satisfaction, symptoms, and resource utilization', 'Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit', 'Emotional', 'low rates of Advance Directive completion', 'High rates of symptom-management admissions', 'Psychological Distress', 'quality-of-life (QOL) concerns', 'QOL outcomes and distress', 'median survival']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0060056', 'cui_str': 'FAM protocol'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",479.0,0.11065,"Well-Being (0.81,  p  = 0.045), with differences on variables of QOL and distress between sites.","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Beckman Research Institute, City of Hope National Medical Center, Duarte, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chung', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, and Beckman Research Institute, City of Hope National Medical Center, Duarte, California, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hughes', 'Affiliation': 'Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Koczywas', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, and Beckman Research Institute, City of Hope National Medical Center, Duarte, California, USA.'}, {'ForeName': 'Nilofer Saba', 'Initials': 'NS', 'LastName': 'Azad', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Nora H', 'Initials': 'NH', 'LastName': 'Ruel', 'Affiliation': 'Department of Computational and Quantitative Medicine, Beckman Research Institute, City of Hope National Medical Center, Duarte, California, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Rhonda S', 'Initials': 'RS', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0597']
1516,33103943,"Surgical Re-intervention Rates After Invasive Treatment for Lower Urinary Tract Symptoms due to Benign Prostatic Syndrome: A Comparative Study of More than 43,000 Patients with Long-Term Follow-Up.","PURPOSE


No large-scale comparison of the four most established surgical approaches for LUTS due to benign prostate obstruction in terms of long-term efficacy is available. We compared photoselective vaporisation, laser enucleation and open simple prostatectomy to transurethral resection with regard to 5-year surgical re-intervention rates.
MATERIALS AND METHODS


43.041 male patients with LUTS who underwent transurethral resection (n=34,526), photoselective vaporisation (n=3,050), laser enucleation (n=1,814) or open simple prostatectomy (n=3,651) between 2011 and 2013 were identified in pseudonymised claims and core data of the German local health care funds (AOK) and followed for 5 years. Surgical re-interventions for LUTS, urethral stricture or bladder neck contracture were evaluated. Surgical approach was related to re-intervention risk using the Kaplan-Meier method and Cox proportional-hazards models.
RESULTS


,050 first re-interventions occurred within 5 years of primary surgery (Kaplan-Meier survival without re-intervention: 87.5%, 95%-CI: 87.2%-87.8%). Photoselective vaporisation carried an increased hazard of re-intervention (HR 1.31, 95%-CI: 1.17-1.46, p <0.001) relative to transurethral resection, open simple prostatectomy carried a lower hazard (HR 0.43, 95%-CI: 0.37-0.50, p <0.001) and LEP did not differ significantly (HR 0.84, 95%-CI: 0.66-1.08, p=0.2). This pattern was more pronounced regarding re-intervention for LUTS recurrence (photoselective vaporisation: HR 1.52, 95%-CI: 1.35-1.72, p <0.001; LEP: HR 0.84, 95%-CI: 0.63-1.14, p=0.3; open simply prostatectomy: HR 0.38, 95%-CI: 0.31-0.46, p <0.001; relative to transurethral resection).
CONCLUSIONS


5-year re-intervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporisation had a substantially higher rate. Open simple prostatectomy remains superior to transurethral resection with respect to long-term efficacy.",2020,"CONCLUSIONS


5-year re-intervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporisation had a substantially higher rate.","['43,000 Patients with Long-Term Follow-Up', 'n=3,651) between 2011 and 2013 were identified in pseudonymised claims and core data of the German local health care funds (AOK) and followed for 5 years', '43.041 male patients with LUTS who underwent']","['transurethral resection (n=34,526), photoselective vaporisation (n=3,050), laser enucleation (n=1,814) or open simple prostatectomy', 'Surgical Re-intervention Rates', 'transurethral resection and laser enucleation', 'photoselective vaporisation, laser enucleation and open simple prostatectomy to transurethral resection']","['LUTS, urethral stricture or bladder neck contracture', 'hazard of re-intervention', 'LEP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0305369,"CONCLUSIONS


5-year re-intervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporisation had a substantially higher rate.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': 'Department of Urology, St. Elisabeth-Hospital Straubing, Straubing, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': 'Department of Urology, St. Elisabeth-Hospital Straubing, Straubing, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Fahlenbrach', 'Affiliation': 'Federal Association of the Local Health Care Funds (AOK), Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Günster', 'Affiliation': 'Research Institute of the Local Health Care Funds (WIdO), Berlin, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Jeschke', 'Affiliation': 'Research Institute of the Local Health Care Funds (WIdO), Berlin, Germany.'}, {'ForeName': 'Gralf', 'Initials': 'G', 'LastName': 'Popken', 'Affiliation': 'Department of Urology, Ernst von Bergmann Hospital, Potsdam, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Stolzenburg', 'Affiliation': 'Department of Urology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Weißbach', 'Affiliation': 'gfm (Gesundheitsforschung für Männer), Berlin, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'von Zastrow', 'Affiliation': 'Medical Review Board of the Social Health Insurance Funds, Hannover, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Leicht', 'Affiliation': 'Research Institute of the Local Health Care Funds (WIdO), Berlin, Germany.'}]",The Journal of urology,['10.1097/JU.0000000000001463']
1517,33103989,Are Posterior Crural Stitches Necessary in Pediatric Laparoscopic Fundoplication?,"Introduction:  Minimal esophageal mobilization during laparoscopic fundoplication decreases the rate of wrap transmigration, and previous study has shown that placement of esophageal-crural sutures does not offer any advantages in preventing wrap migration. Our aim was to determine the need for posterior crural sutures during laparoscopic fundoplication.  Methods:  This was a retrospective review of patients >1 month old who underwent a primary laparoscopic fundoplication from 2010 to 2019. Demographic, surgical, and outcome data were recorded. Primary outcome was transmigration of the fundoplication wrap. Analysis was performed using STATA ®  (StataCorp, College Station, TX);  P  value <.05 was significant.  Results:  There were 181 patients included. The median age was 7.2 months (interquartile range [IQR] 3.7, 17.0) with 59% being male patients. Sixty-one (34%) patients received posterior crural stitches and 120 (66%) did not receive stitches according to staff preference. The stitch group had a median of 1 (IQR 1, 1) posterior crural stitches placed. There was no difference in the incidence of wrap migration, the number of patients requiring a workup for recurrent symptoms, or reoperation between the two groups (Table 1). A significantly higher percentage of patients in the no-stitch group underwent concurrent procedures; when controlled for this, there was no difference in the median operative time between the groups ( P  = .18).  Conclusion:  The placement of crural sutures, including the posterior crural suture, does not prevent wrap migration and may not be necessary for prevention of wrap herniation in pediatric fundoplication.",2020,"There was no difference in the incidence of wrap migration, the number of patients requiring a workup for recurrent symptoms, or reoperation between the two groups (Table 1).","['181 patients included', 'patients >1 month old who underwent a primary laparoscopic fundoplication from 2010 to 2019']",['laparoscopic fundoplication'],"['median operative time', 'transmigration of the fundoplication wrap', 'incidence of wrap migration, the number of patients requiring a workup for recurrent symptoms, or reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0521257', 'cui_str': 'Laparoscopic fundoplication'}]","[{'cui': 'C0521257', 'cui_str': 'Laparoscopic fundoplication'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",,0.148352,"There was no difference in the incidence of wrap migration, the number of patients requiring a workup for recurrent symptoms, or reoperation between the two groups (Table 1).","[{'ForeName': 'Wendy Jo', 'Initials': 'WJ', 'LastName': 'Svetanoff', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dekonenko', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Kayla B', 'Initials': 'KB', 'LastName': 'Briggs', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fraser', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Tolulope A', 'Initials': 'TA', 'LastName': 'Oyetunji', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'St Peter', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, USA.""}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0646']
1518,33104004,Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial.,"BACKGROUND


Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use.
OBJECTIVE


The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain.
METHODS


In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits.
RESULTS


After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups.
CONCLUSIONS


EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.",2020,"Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively).","['patients with chronic low back pain who are contraindicated for oral NSAIDs', '83 patients who experienced chronic low back pain were analyzed', 'patients with chronic low back pain', 'Chronic Low Back Pain']","['Electronic Acupuncture Shoes', 'Electronic acupuncture shoes (EAS', 'acupuncture and transcutaneous electrical nerve stimulation', 'EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID', 'EAS', 'acupuncture or electroacupuncture']","['visual analog scale (VAS) score and range of motion', 'low back pain', 'intention-to-treat (ITT) and per-protocol (PP) analyses', 'success rate', 'time for achieving pain remission', 'VAS score', 'Quality of life', 'quality of life', 'left rotation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.222761,"Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively).","[{'ForeName': 'Bo-Yan', 'Initials': 'BY', 'LastName': 'Yeh', 'Affiliation': 'Division of Acupuncture and Moxibustion, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.'}, {'ForeName': 'Geng-Hao', 'Initials': 'GH', 'LastName': 'Liu', 'Affiliation': 'Division of Acupuncture and Moxibustion, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.'}, {'ForeName': 'Tzung-Yan', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Traditional Chinese Medicine, School of Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alice May-Kuen', 'Initials': 'AM', 'LastName': 'Wong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hen-Hong', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, and Chinese Medicine Research Center, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Division of Acupuncture and Moxibustion, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.'}]",Journal of medical Internet research,['10.2196/22324']
1519,33104014,The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial.,"BACKGROUND


The rising prevalence of nonalcoholic fatty liver disease (NAFLD) and the more aggressive subtype, nonalcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure, and death. The current standard for diagnosing and staging liver disease is a liver biopsy, which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective, noninvasive diagnostic tool for these conditions. LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies.
OBJECTIVE


The primary objective of this trial (RADIcAL1) is to evaluate the cost-effectiveness of the introduction of LiverMultiScan as a standardized diagnostic test for liver disease in comparison to standard care for NAFLD, in different EU territories.
METHODS


RADIcAL1 is a multi-center randomized control trial with 2 arms conducted in 4 European territories (13 sites, from across Germany, Netherlands, Portugal, and the United Kingdom). In total, 1072 adult patients with suspected fatty liver disease will be randomized to be treated according to the result of the mpMRI in the intervention arm, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. Patients in the control arm will be treated as per center guidelines for standard of care. The primary outcome for this trial is to compare the difference in the proportion of patients with suspected NAFLD incurring liver-related hospital consultations or liver biopsies between the study arms, from the date of randomization to the end of the study follow-up. Secondary outcomes include patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time, from randomization to diagnosis by the physician, as recorded at the final follow-up visit.
RESULTS


This trial is currently open for recruitment. The anticipated completion date for the study is December 2020.
CONCLUSIONS


This randomized controlled trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools in existing NAFLD/NASH clinical care. RADIcAL1 is among the first and largest European health economic studies of imaging technologies for fatty liver disease. Strengths of the trial include a high-quality research design and an in-depth assessment of the implementation of the cost-effectiveness of the mpMRI diagnostic. If effective, the trial may highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary consultations and invasive diagnostic investigations, and demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations or liver biopsies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03289897 https://clinicaltrials.gov/ct2/show/NCT03289897.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19189.",2020,"LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies.
","['1072 adult patients with suspected fatty liver disease', '4 European territories (13 sites, from across Germany, Netherlands, Portugal, and the United Kingdom']","['Multi-Parametric Magnetic Resonance Imaging', 'NAFLD/NASH', 'LiverMultiScan']","['patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time, from randomization to diagnosis by the physician, as recorded at the final follow-up visit', 'proportion of patients with suspected NAFLD incurring liver-related hospital consultations or liver biopsies']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}]",1072.0,0.176473,"LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies.
","[{'ForeName': 'Dimitar', 'Initials': 'D', 'LastName': 'Tonev', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shumbayawonda', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Louise Ann', 'Initials': 'LA', 'LastName': 'Tetlow', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Herdman', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'French', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Soubera', 'Initials': 'S', 'LastName': 'Rymell', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Caseiro-Alves', 'Affiliation': 'University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Castelo-Branco', 'Affiliation': 'University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferreira', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Minneke', 'Initials': 'M', 'LastName': 'Coenraad', 'Affiliation': 'Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Hildo', 'Initials': 'H', 'LastName': 'Lamb', 'Affiliation': 'Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Meinrad', 'Initials': 'M', 'LastName': 'Beer', 'Affiliation': 'University Klinik Ulm, Ulm, Germany.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Perspectum Ltd, Oxford, United Kingdom.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dollinger', 'Affiliation': 'University Klinik Ulm, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""See Authors' Contributions, .""}]",JMIR research protocols,['10.2196/19189']
1520,33104016,A three-week intervention emphasized diagonal eccentric contraction on balance and joint position sense and ankle strength in subjects with ankle instability: A randomized controlled trial.,"BACKGROUND


Problems related to ankle instability, decreased proprioceptive sensation, altered static and dynamic balance abilities are suggested as major representative factors that contribute to the recurrence of ankle sprains.
OBJECTIVE


To assess the effect of a three-week intervention (intervention emphasizing diagonal eccentric contraction (IEDEC) and intervention of general exercise (IGE)) on static and dynamic balance abilities, ankle strength and joint position sense at pre- and post-intervention, and at two- and three-week post-intervention.
METHODS


Twenty-five participants with ankle instability, including a history of ankle sprain and recurrent episodes of giving way, were enrolled in the study. They were randomly classified into the IEDEC group (n= 12) and the IGE group (n= 13). Dynamic balance was examined using the Y Balance Test, four-way ankle strength was measured, and the static balance was evaluated using the total displacement of the center of pressure (COP). To identify the joint position error, eversion and inversion of the ankle angle were measured.
RESULTS


The results revealed significant increases in ankle dynamic stability and strength at two and three weeks post-intervention (p< 0.05). Similarly, the total displacement of the COP differed significantly over time, with a higher COP during the initial measurement than at two and three weeks intervention (p< 0.05) General balance training with IEDEC can improve position sense during ankle inversion (p< 0.05).
CONCLUSION


General balance training with IEDEC improved the position sense of the inversion. Combined therapeutic intervention, such as with the manual technique, could be a beneficial approach to maximize the treatment effects.",2020,"General balance training with IEDEC can improve position sense during ankle inversion (p< 0.05).
","['subjects with ankle instability', 'Twenty-five participants with ankle instability, including a history of ankle sprain and recurrent episodes of giving way, were enrolled in the study']","['pre- and post-intervention, and at two- and three-week post-intervention', 'IGE', 'IEDEC', 'three-week intervention (intervention emphasizing diagonal eccentric contraction (IEDEC) and intervention of general exercise (IGE']","['total displacement of the center of pressure (COP', 'Dynamic balance', 'total displacement of the COP', 'position sense', 'joint position error, eversion and inversion of the ankle angle', 'static and dynamic balance abilities, ankle strength and joint position sense', 'balance and joint position sense and ankle strength', 'ankle dynamic stability and strength']","[{'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0443287', 'cui_str': 'Recurrent episode'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",25.0,0.0250171,"General balance training with IEDEC can improve position sense during ankle inversion (p< 0.05).
","[{'ForeName': 'Du-Jin', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Catholic University of Pusan, Busan, Korea.'}, {'ForeName': 'Byeong-Jo', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Nursing, Healthcare Sciences and Human Ecology, Dongeui University, Busan, Korea.'}, {'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Biomedical Science, Masan University, Changwon, Korea.'}, {'ForeName': 'Se-Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Biomedical Science, Kaya University, Gimhae, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200058']
1521,33104028,Randomized Controlled Trial of Multi-Component Cognitive Stimulation Therapy (SADEM) in Community-Dwelling Demented Adults.,"BACKGROUND


Dementia is a persistent, progressive state of cognitive decline against which pharmacological intervention has a modest efficacy, reducing behavioral but not cognitive symptoms. Therefore, different non-pharmacological therapies have been developed; the most scientifically recognized are cognitive therapies that have improved cognitive function and daily life activities.
OBJECTIVE


To evaluate the effectiveness of a multicomponent cognitive stimulation therapy (SADEM) on cognitive and behavioral function and daily life activities in patients with mild stage dementia.
METHODS


Controlled clinical trial with pre- and post-intervention (12 months) and follow-up (24 months after) evaluations. Participants (67) diagnosed with mild dementia were randomly assigned to intervention group (n = 39) or control group (n = 28). The intervention took place throughout one year and consisted of two weekly 90-minute sessions and one more a year after a monthly follow-up. Instruments were used to evaluate outcomes in cognitive, behavioral, and affective domains.
RESULTS


The results showed statistically significant differences, with improvement in the cognitive outcomes and the Dementia Index post-intervention (p = 0.01). No progression of the disease was observed at the end of the study.
CONCLUSION


The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.",2020,"The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.","['Community-Dwelling Demented Adults', 'patients with mild stage dementia', 'Participants (67) diagnosed with mild dementia', 'people with mild stage dementia, delaying progression for at least two years']","['multicomponent cognitive stimulation therapy (SADEM', 'pre- and post-intervention', 'Multi-Component Cognitive Stimulation Therapy (SADEM']","['cognitive and behavioral functions and daily life activities', 'cognitive, behavioral, and affective domains', 'cognitive outcomes and the Dementia Index post-intervention', 'cognitive and behavioral function and daily life activities']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",67.0,0.0736016,"The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Juárez-Cedillo', 'Affiliation': 'Unidad de Investigación en Epidemiología y Servicios de Salud, Área Envejecimiento, Instituto Mexicano del Seguro Social, Centro Medico Nacional Siglo XXI, Mexico City, México.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gutiérrez-Gutiérrez', 'Affiliation': 'Department of Neurology and Psychiatry, National Institute of Medical Sciences and Nutrition ""Salvador Zubirán"", National Institutes of Health, Mexico City, Mexico.'}, {'ForeName': 'Luis Alejandro', 'Initials': 'LA', 'LastName': 'Sánchez-Hurtado', 'Affiliation': 'Departamento de Medicina de Cuidados Críticos, Hospital Especialidades Centro Médico Nacional La Raza, Instituto Mexicano de Seguridad Social, Mexico City, Mexico.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Epidemiology, Endocrinology & Nutrition Research, Hospital Infantil de México Federico Gomez; (SSA), Mexico City, Mexico.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Juarez-Cedillo', 'Affiliation': 'Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200574']
1522,33104176,Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial.,"Importance


The use of isotonic fluid therapy is currently recommended in children, but there is limited evidence of optimal fluid therapy in acutely ill children.
Objective


To evaluate the risk for electrolyte disorders, including hyponatremia, hypernatremia, and hypokalemia, and the risk of fluid retention in acutely ill children receiving commercially available plasmalike isotonic fluid therapy.
Design, Setting, and Participants


This unblinded, randomized clinical pragmatic trial was conducted at the pediatric emergency department of Oulu University Hospital, Finland, from October 3, 2016, through April 15, 2019. Eligible study subjects (N = 614) were between 6 months and 12 years of age, required hospitalization due to an acute illness, and needed intravenous fluid therapy. Exclusion criteria included a plasma sodium concentration of less than 130 mmol/L or greater than 150 mmol/L on admission; a plasma potassium concentration of less than 3.0 mmol/L on admission; clinical need of fluid therapy with 10% glucose solution; a history of diabetes, diabetic ketoacidosis, or diabetes insipidus; a need for renal replacement therapy; severe liver disease; pediatric cancer requiring protocol-determined chemotherapy hydration; and inborn errors of metabolism. All outcomes and samples size were prespecified except those clearly marked as exploratory post hoc analyses. All analyses were intention to treat.
Interventions


Acutely ill children were randomized to receive commercially available plasmalike isotonic fluid therapy (140 mmol/L of sodium and 5 mmol/L potassium in 5% dextrose) or moderately hypotonic fluid therapy (80 mmol/L sodium and 20 mmol/L potassium in 5% dextrose).
Main Outcomes and Measures


The primary outcome was the proportion of children with any clinically significant electrolyte disorder, defined as hypokalemia less than 3.5 mmol/L, hypernatremia greater than 148 mmol/L, or hyponatremia less than 132 mmol/L during hospitalization due to acute illness. The main secondary outcomes were the proportion of children with severe hypokalemia and weight change.
Results


There were 614 total study subjects (mean [SD] age, 4.0 [3.1] years; 315 children were boys [51%] and all 614 were Finnish speaking [100%]). Clinically significant electrolyte disorder was more common in children receiving plasmalike isotonic fluid therapy (61 of 308 patients [20%]) compared with those receiving moderately hypotonic fluid therapy (9 of 306 patients [2.9%]; 95% CI of the difference, 12%-22%; P < .001). The risk of developing electrolyte disorder was 6.7-fold greater in children receiving isotonic fluid therapy. Hypokalemia developed in 57 patients (19%) and hypernatremia developed in 4 patients (1.3%) receiving plasmalike isotonic fluid therapy. Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
Conclusions and Relevance


In this randomized clinical trial, commercially available plasmalike isotonic fluid therapy markedly increased the risk for clinically significant electrolyte disorders, mostly due to hypokalemia, in acutely ill children compared with previously widely used moderately hypotonic fluid therapy containing 20 mmol/L of potassium.
Trial Registration


ClinicalTrials.gov identifier: NCT02926989.",2020,"Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
","['children receiving isotonic fluid therapy', 'acutely ill children', 'Exclusion criteria included a plasma sodium concentration of less than 130 mmol/L or greater than 150 mmol/L on admission; a plasma potassium concentration of less than 3.0 mmol/L on admission; clinical need of fluid therapy with 10% glucose solution; a history of diabetes, diabetic ketoacidosis, or diabetes insipidus; a need for renal replacement therapy; severe liver disease; pediatric cancer requiring protocol-determined chemotherapy hydration; and inborn errors of metabolism', 'Eligible study subjects (N\u2009=\u2009614) were between 6 months and 12 years of age, required hospitalization due to an acute illness, and needed intravenous fluid therapy', 'pediatric emergency department of Oulu University Hospital, Finland, from October 3, 2016, through April 15, 2019', 'Interventions\n\n\nAcutely ill children', 'Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids', 'acutely ill children receiving commercially available plasmalike isotonic fluid therapy', '614 total study subjects (mean [SD] age, 4.0 [3.1] years; 315 children were boys [51%] and all 614 were Finnish speaking [100']","['isotonic fluid therapy', 'plasmalike isotonic fluid therapy', 'commercially available plasmalike isotonic fluid therapy (140 mmol/L of sodium and 5 mmol/L potassium in 5% dextrose) or moderately hypotonic fluid therapy (80 mmol/L sodium and 20 mmol/L potassium in 5% dextrose']","['proportion of children with severe hypokalemia and weight change', 'proportion of children with any clinically significant electrolyte disorder', 'hypernatremia', 'hypokalemia less', 'Hypokalemia', 'Weight change']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0858175', 'cui_str': 'Plasma sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0025521', 'cui_str': 'Inborn error of metabolism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0342579', 'cui_str': 'Electrolyte imbalance'}, {'cui': 'C0020488', 'cui_str': 'Hypernatremia'}]",315.0,0.349775,"Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
","[{'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Lehtiranta', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Honkila', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kallio', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Paalanne', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Peltoniemi', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Renko', 'Affiliation': 'Research Unit of Pediatrics, Dermatology, Gynecology, and Obstetrics, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Tapiainen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3383']
1523,33104189,Risk of Overcorrection in Rapid Intermittent Bolus vs Slow Continuous Infusion Therapies of Hypertonic Saline for Patients With Symptomatic Hyponatremia: The SALSA Randomized Clinical Trial.,"Importance


Few high-quality studies have clarified whether hypertonic saline is best administered as slow continuous infusion (SCI) therapy or rapid intermittent bolus (RIB) therapy for symptomatic severe hyponatremia.
Objective


To compare the risk of overcorrection in RIB and SCI with hypertonic saline in patients with symptomatic hyponatremia.
Design, Setting, and Participants


This prospective, investigator-initiated, multicenter, open-label, randomized clinical trial enrolled 178 patients older than 18 years with moderately severe to severe hyponatremia and glucose-corrected serum sodium (sNa) levels of 125 mmol/L or less. Recruitment took place from August 24, 2016, until August 21, 2019, across emergency departments and wards of 3 general hospitals in the Republic of Korea.
Interventions


Either RIB or SCI of hypertonic saline, 3%, for 24 to 48 hours stratified by the severity of clinical symptoms.
Main Outcome and Measures


The primary outcome was overcorrection at any given period, defined as increase in the sNa level by greater than 12 or 18 mmol/L within 24 or 48 hours, respectively. Secondary and post hoc outcomes included efficacy and safety of the treatment approaches. The sNa concentrations were measured every 6 hours for 2 days.
Results


The 178 patients (mean [SD] age, 73.1 [12.2] years; 80 (44.9%) male; mean [SD] sNa concentrations, 118.2 [5.0] mmol/L) were randomly assigned to the RIB group (n = 87) or the SCI group (n = 91). Overcorrection occurred in 15 of 87 (17.2%) and 22 of 91 (24.2%) patients in the RIB and SCI groups, respectively (absolute risk difference, -6.9% [95% CI, -18.8% to 4.9%]; P = .26). The RIB group showed lower incidence of relowering treatment than the SCI group (36 of 87 [41.4%] vs 52 of 91 [57.1%] patients, respectively; absolute risk difference, -15.8% [95% CI, -30.3% to -1.3%]; P = .04; number needed to treat, 6.3). Groups did not differ in terms of efficacy in increasing sNa concentrations nor improving symptoms, but RIB, when compared with SCI, showed better efficacy in achieving target correction rate within 1 hour (intention-to-treat analysis: 28 of 87 (32.2%) vs 16 of 91 (17.6%) patients, respectively; absolute risk difference, 14.6% [95% CI, 2%-27.2%]; P = .02; number needed to treat, 6.8; per-protocol analysis: 21 of 72 (29.2%) vs 12 of 73 (16.4%) patients, respectively; absolute risk difference, 12.7% [95% CI, -0.8% to 26.2%]; P = .07). The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
Conclusions and Relevance


This randomized clinical trial found that both RIB and SIC therapies of hypertonic saline for treating hyponatremia were effective and safe, with no difference in the overcorrection risk. However, RIB had a lower incidence of therapeutic relowering treatment and tended to have a better efficacy in achieving sNa within 1 hour than SCI. RIB could be suggested as the preferred treatment of symptomatic hyponatremia, which is consistent with the current consensus guidelines.
Trial Registration


ClinicalTrials.org Identifier: NCT02887469.",2020,"The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
","['178 patients older than 18 years with moderately severe to severe hyponatremia and glucose-corrected serum sodium (sNa) levels of 125 mmol/L or less', '178 patients (mean [SD] age, 73.1 [12.2] years; 80 (44.9%) male; mean [SD] sNa concentrations, 118.2 [5.0] mmol/L', 'Patients With Symptomatic Hyponatremia', 'Recruitment took place from August 24, 2016, until August 21, 2019, across emergency departments and wards of 3 general hospitals in the Republic of Korea', 'patients with symptomatic hyponatremia']","['SCI', 'slow continuous infusion (SCI) therapy or rapid intermittent bolus (RIB) therapy', 'Hypertonic Saline', 'hypertonic saline']","['overcorrection at any given period', 'efficacy and safety', 'lower incidence of relowering treatment', 'sNa level', 'sNa concentrations', 'Overcorrection', 'target correction rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376252', 'cui_str': 'Shona language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376252', 'cui_str': 'Shona language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",178.0,0.323637,"The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
","[{'ForeName': 'Seon Ha', 'Initials': 'SH', 'LastName': 'Baek', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Kristianne', 'Initials': 'K', 'LastName': 'Medina-Liabres', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Yun Kyu', 'Initials': 'YK', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Bok', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sejoong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5519']
1524,33104258,Prospective study of the effect of sulfotanshinone sodium combined with tirofiban on vascular endothelial function and indicators of plaque stability in elderly patients with acute coronary syndrome.,"WHAT IS KNOWN AND OBJECTIVE


This study aimed to explore the effect of sulfotanshinone sodium injection combined with tirofiban on vascular endothelial function and indicators of plaque stability in elderly patients with acute coronary syndrome (ACS).
METHODS


We designed a prospective study and enrolled 169 patients with ACS who were admitted to our hospital as subjects. Patients treated with sulfotanshinone sodium injection combined with tirofiban (n = 99) were allocated to the research group (RG), and the remaining patients treated with tirofiban alone were allocated to the control group (n = 70; CG). The two groups were compared in terms of treatment efficacy, adverse reactions, vascular endothelial function, changes in plaque stability indicator levels, prognosis, recurrence rate, and quality of life after the treatment.
RESULTS AND DISCUSSION


Treatment response rate, SOD and ET-1 levels, and quality-of-life score were markedly lower in RG than in CG (all P < .05). The incidence of adverse reactions; levels of CD63p, CD62p and GP IIb/IIIa; changes in plaque stability indicator levels; and recurrence rate were markedly higher in RG than in CG (all P < .05). There was no significant difference in 3-year survival rate between the two groups (P > .05).
WHAT IS NEW AND CONCLUSION


Compared with tirofiban alone, sulfotanshinone sodium injection combined with tirofiban had superior efficacy and safety in the treatment of ACS. It can effectively reduce recurrence rate and improve quality of life in ACS, making it a strong candidate for popular clinical application.",2020,"The incidence of adverse reactions; levels of CD63p, CD62p and GP IIb/IIIa; changes in plaque stability indicator levels; and recurrence rate were markedly higher in RG than in CG (all P < .05).","['enrolled 169 patients with ACS who were admitted to our hospital as subjects', 'elderly patients with acute coronary syndrome', 'n\xa0=\xa099', 'elderly patients with acute coronary syndrome (ACS']","['sulfotanshinone sodium combined with tirofiban', 'tirofiban', 'sulfotanshinone sodium injection combined with tirofiban']","['treatment efficacy, adverse reactions, vascular endothelial function, changes in plaque stability indicator levels, prognosis, recurrence rate, and quality of life after the treatment', '3-year survival rate', 'incidence of adverse reactions; levels of CD63p, CD62p and GP IIb/IIIa; changes in plaque stability indicator levels; and recurrence rate', 'response rate, SOD and ET-1 levels, and quality-of-life score', 'recurrence rate', 'quality of life', 'vascular endothelial function and indicators of plaque stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",169.0,0.0348981,"The incidence of adverse reactions; levels of CD63p, CD62p and GP IIb/IIIa; changes in plaque stability indicator levels; and recurrence rate were markedly higher in RG than in CG (all P < .05).","[{'ForeName': 'Shuqing', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}, {'ForeName': 'Xinze', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}, {'ForeName': 'Guiliang', 'Initials': 'G', 'LastName': 'Zhai', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}, {'ForeName': 'Chenggang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}, {'ForeName': 'Shufeng', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency, Binzhou Center Hospital, Binzhou, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13283']
1525,33104268,"Depression, Alcoholics Anonymous Involvement, and Daily Drinking Among Patients with Cooccurring Conditions: A Longitudinal Parallel Growth Mixture Model.","BACKGROUND


Patients with cooccurring mental health and substance use disorders often find it difficult to sustain long-term recovery. One predictor of recovery may be how depression symptoms and Alcoholics Anonymous (AA) involvement influence alcohol consumption during and after inpatient psychiatric treatment. This study utilized a parallel growth mixture model to characterize the course of alcohol use, depression, and AA involvement in patients with cooccurring diagnoses.
METHODS


Participants were adults with cooccurring disorders (n = 406) receiving inpatient psychiatric care as part of a telephone monitoring clinical trial. Participants were assessed at intake, 3-, 9-, and 15-month follow-up.
RESULTS


A 3-class solution was the most parsimonious based upon fit indices and clinical relevance of the classes. The classes identified were high AA involvement with normative depression (27%), high stable depression with uneven AA involvement (11%), and low AA involvement with normative depression (62%). Both the low and high AA classes reduced their drinking across time and were drinking at less than half their baseline levels at all follow-ups. The high stable depression class reported an uneven pattern of AA involvement and drank at higher daily frequencies across the study timeline. Depression symptoms and alcohol use decreased substantially from intake to 3 months and then stabilized for 90% of patients with cooccurring disorders following inpatient psychiatric treatment.
CONCLUSIONS


These findings can inform future clinical interventions among patients with cooccurring mental health and substance use disorders. Specifically, patients with more severe symptoms of depression may benefit from increased AA involvement, whereas patients with less severe symptoms of depression may not.",2020,Both the low and high AA classes reduced their drinking across time and were drinking at less than half their baseline levels at all follow-ups.,"['Patients with cooccurring mental health and substance use disorders', 'patients with cooccurring mental health and substance use disorders', 'Participants were adults with cooccurring disorders (n\xa0=\xa0406) receiving inpatient psychiatric care as part of a telephone monitoring clinical trial', 'Patients with Cooccurring Conditions', 'patients with cooccurring diagnoses']",[],['Depression symptoms and alcohol use'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",406.0,0.0285022,Both the low and high AA classes reduced their drinking across time and were drinking at less than half their baseline levels at all follow-ups.,"[{'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Vest', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences (NAV, KH, CT), Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sox-Harris', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, (AHSH, KH, CT), Palo Alto, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ilgen', 'Affiliation': 'Department of Psychiatry, (MI), University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Humphreys', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences (NAV, KH, CT), Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Timko', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences (NAV, KH, CT), Stanford University School of Medicine, Stanford, California, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14474']
1526,33104279,Enhancing Integrative Cognitive-Affective Therapy with ecological momentary interventions: A pilot trial.,"OBJECTIVE


Although current treatments are effective for some patients with eating disorders, a large number of patients remain partially or fully symptomatic post-treatment. This may be related to poor utilization of treatment skills outside of the therapy office. Smartphone applications that can detect and intervene during moments of need could facilitate such skill use between sessions.
METHOD


Individuals (N = 16) participated in a small pilot open trial where they received 21 sessions of in-person Integrative Cognitive-Affective Therapy (ICAT) therapy an app (iCAT+) that delivers ecological momentary interventions (EMI) in response to user-entered data. Data were collected on the feasibility and acceptability of this treatment approach and on preliminary indicators of treatment outcomes.
RESULTS


Participants found iCAT+ as a treatment augmentation acceptable and indicated it had clinical utility as an adjunct to in-person therapy, although analyses indicated poor compliance with data entry needed to trigger EMI delivery. This suggests that long-term use of EMI requiring ongoing data entry is infeasible.
CONCLUSIONS


We describe lessons learned from our initial pilot trial and future directions for the development of impactful EMI systems that can be used to augment in-person therapies.",2020,"RESULTS


Participants found iCAT+ as a treatment augmentation acceptable and indicated it had clinical utility as an adjunct to in-person therapy, although analyses indicated poor compliance with data entry needed to trigger EMI delivery.","['Individuals (N = 16', 'patients with eating disorders']","['21 sessions of in-person Integrative Cognitive-Affective Therapy (ICAT) therapy an app (iCAT+) that delivers ecological momentary interventions (EMI', 'iCAT', 'Integrative Cognitive-Affective Therapy with ecological momentary interventions']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],16.0,0.020652,"RESULTS


Participants found iCAT+ as a treatment augmentation acceptable and indicated it had clinical utility as an adjunct to in-person therapy, although analyses indicated poor compliance with data entry needed to trigger EMI delivery.","[{'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rowan A', 'Initials': 'RA', 'LastName': 'Hunt', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lantz Lesser', 'Affiliation': 'Sanford Health/Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, North Dakota, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Health/Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, North Dakota, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Pisetsky', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Health/Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, North Dakota, USA.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2800']
1527,33106028,Medium-Term Results of Corticosteroid Injections for Morton's Neuroma.,"BACKGROUND


The objective of this study was to evaluate the medium-term results of corticosteroid injections for Morton's neuroma.
METHODS


This was a prospective follow-up study of a previous randomized controlled trial (RCT). Forty-five neuromas in 36 patients were injected with a single corticosteroid injection either with or without ultrasound guidance. As the results of the RCT showed no difference in outcomes between techniques, the data were pooled for the purpose of this study. Questionnaires were sent out and responses were collected via mail or telephone interview. Results were available in 42 out of 45 neuromas. There was a sex split of 68% female/32% male with a mean age of 62.6 years (SD, 12 years).
RESULTS


At mean follow-up of 4.8 years (SD, 0.91 years), the original corticosteroid injection remained effective in 36% ( n  = 16) of the patients. In these cases, the visual analog scale (VAS) pain score ( P  < .001) and Manchester-Oxford Foot Questionnaire Index (MOxFQ Index) ( P  = .001) remained significantly better than preintervention scores. The remaining cases underwent either a further injection or surgery. Fifty-five percent of the 11 neuromas that received a second injection continued to be asymptomatic in the medium term. Overall, 44% ( n  = 20) of the initial cohort underwent surgical excision by the medium-term follow-up. The VAS score, MOxFQ Index, and satisfaction scale score across all groups were not significantly different.
CONCLUSION


Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years. A positive outcome at 1 year following a corticosteroid injection was reasonably predictive of a prolonged effect from the injection.
LEVEL OF EVIDENCE


Level II, prospective comparative study.",2020,Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years.,"[""Morton's Neuroma"", 'Forty-five neuromas in 36 patients', 'sex split of 68% female/32% male with a mean age of 62.6 years (SD, 12 years']","['corticosteroid injection', 'Corticosteroid Injections', 'corticosteroid injection either with or without ultrasound guidance', 'Corticosteroid injections', 'corticosteroid injections']","['Manchester-Oxford Foot Questionnaire Index (MOxFQ Index', 'VAS score, MOxFQ Index, and satisfaction scale score', 'visual analog scale (VAS) pain score']","[{'cui': 'C0311337', 'cui_str': ""Morton's neuroma""}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027858', 'cui_str': 'Neuroma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",36.0,0.0273226,Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years.,"[{'ForeName': 'Melinda Yun Ting', 'Initials': 'MYT', 'LastName': 'Hau', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Aujla', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Madhadevan', 'Affiliation': 'Trauma and Orthopaedic Surgery, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Bhatia', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}]",Foot & ankle international,['10.1177/1071100720966332']
1528,33106049,Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial.,"BACKGROUND


Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary.
METHODS


MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure.
RESULTS


A total of 109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled. Postprocedural minimum stent area was 6.31±1.89 and 6.72±2.08 mm 2  in OFDI and IVUS group, respectively ( P =0.26). At the 8-month follow-up, in-segment minimum lumen area was 4.56±1.94 and 4.13±1.86 mm 2  in OFDI and IVUS group, respectively ( P non-inferiority  <0.001). Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43). The incidence rate of device-oriented composite end point at 3 years was 7.4% and 7.3% in OFDI and IVUS group, respectively (hazard ratio, 1.05 [95% CI, 0.26-4.18];  P =0.95).
CONCLUSIONS


OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03292081.",2020,"Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43).","['109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled', 'Patients with stable coronary artery disease']","['intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI', 'OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance', 'OFDI- and IVUS-guided PCI', 'Stent Implantation', 'Optical Frequency Domain Imaging and Intravascular Ultrasound']","['composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point', 'Postprocedural OFDI', 'Postprocedural minimum stent area', 'segment minimum lumen area assessed using OFDI', 'incidence rate of device-oriented composite end point', 'neointimal healing score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",109.0,0.122019,"Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Nanasato', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan (M.N.).'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Ohota', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yoshiki', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Hidemaro', 'Initials': 'H', 'LastName': 'Takatsu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Radiology, Fujita Health University Hospital, Toyoake, Japan. (K.I.).'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Japan (H.K.).'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Japanese Red Cross Nagoya Daini Hospital, Japan (Y. Yoshida).'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Japan (T.M.).'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Izawa', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan. (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009314']
1529,33106057,Impact of anti-gravity treadmill rehabilitation therapy on the clinical outcomes after fixation of lower limb fractures: A randomized clinical trial.,"OBJECTIVE


To compare the effects of anti-gravity treadmill rehabilitation with those of standard rehabilitation on surgically treated ankle and tibial plateau fractures.
DESIGN


Open-label prospective randomized multicenter study.
SETTING


Three level 1 trauma centers.
SUBJECTS


Patients with tibial plateau or ankle fractures who underwent postoperative partial weight-bearing were randomized into the intervention (anti-gravity treadmill use) or control (standard rehabilitation protocol) groups.
MAIN MEASURES


The primary endpoint was the change in the Foot and Ankle Outcome Score for ankle fractures and total Knee injury and Osteoarthritis Outcome Score for tibial plateau fractures (0-100 points) from baseline (T1) to six weeks after operation (T4) in both groups. Leg circumference of both legs was measured to assess thigh muscle atrophy in the operated leg.
RESULTS


Thirty-seven patients constituted the intervention and 36 the control group, respectively; 14 patients dropped out during the follow-up period. Among the 59 remaining patients (mean age 42 [range, 19-65] years), no difference was noted in the Foot and Ankle Outcome Score (54.2 ± 16.1 vs. 56.0 ± 16.6) or Knee injury and Osteoarthritis Outcome Score (52.8 ± 18.3 vs 47.6 ± 17.7) between the intervention and control groups 6 weeks after operation. The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005). No adverse event associated with anti-gravity treadmill rehabilitation was observed.
CONCLUSION


No significant difference was noted in patient-reported outcomes between the two groups. Significant differences in muscular atrophy of the thigh were observed six weeks after operation.",2020,"The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005).","['Three level 1 trauma centers', 'lower limb fractures', 'Patients with tibial plateau or ankle fractures who underwent postoperative partial weight-bearing', '59 remaining patients (mean age 42 [range, 19-65] years']","['anti-gravity treadmill rehabilitation', 'anti-gravity treadmill rehabilitation therapy', 'standard rehabilitation', 'intervention (anti-gravity treadmill use) or control (standard rehabilitation protocol) groups']","['muscular atrophy of the thigh', 'leg circumference', 'Leg circumference of both legs', 'change in the Foot and Ankle Outcome Score for ankle fractures and total Knee injury and Osteoarthritis Outcome Score for tibial plateau fractures', 'Knee injury and Osteoarthritis Outcome Score', 'Foot and Ankle Outcome Score']","[{'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204014', 'cui_str': 'Use of treadmill'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}]",,0.0652364,"The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2-8.0,  P  = 0.005).","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Henkelmann', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Palke', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Clinic of Trauma, Orthopedic and Septic Surgery, Hospital St. Georg gGmbH, Leipzig, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Ambulantes Reha Centrum Leipzig GmbH, Leipzig, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Karich', 'Affiliation': 'Department of Trauma and Physical Medicine, Heinrich-Braun-Klinikum Gemeinnützige GmbH, Zwickau, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Mende', 'Affiliation': 'Coordinating Centre for Clinical Trials and Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Josten', 'Affiliation': 'Department of Orthopedics, Trauma and Plastic Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Böhme', 'Affiliation': 'Clinic of Trauma, Orthopedic and Septic Surgery, Hospital St. Georg gGmbH, Leipzig, Germany.'}]",Clinical rehabilitation,['10.1177/0269215520966857']
1530,33106087,"Risk Ladder, Table, or Bulleted List? Identifying Formats That Effectively Communicate Personalized Risk and Risk Reduction Information for Multiple Diseases.","BACKGROUND


Personalized medicine may increase the amount of probabilistic information patients encounter. Little guidance exists about communicating risk for multiple diseases simultaneously or about communicating how changes in risk factors affect risk (hereafter ""risk reduction"").
PURPOSE


To determine how to communicate personalized risk and risk reduction information for up to 5 diseases associated with insufficient physical activity in a way laypeople can understand and that increases intentions.
METHODS


We recruited 500 participants with <150 min weekly of physical activity from community settings. Participants completed risk assessments for diabetes, heart disease, stroke, colon cancer, and breast cancer (women only) on a smartphone. Then, they were randomly assigned to view personalized risk and risk reduction information organized as a bulleted list, a simplified table, or a specialized vertical bar graph (""risk ladder""). Last, they completed a questionnaire assessing outcomes. Personalized risk and risk reduction information was presented as categories (e.g., ""very low""). Our analytic sample ( N  = 372) included 41.3% individuals from underrepresented racial/ethnic backgrounds, 15.9% with vocational-technical training or less, 84.7% women, 43.8% aged 50 to 64 y, and 71.8% who were overweight/obese.
RESULTS


Analyses of covariance with post hoc comparisons showed that the risk ladder elicited higher gist comprehension than the bulleted list ( P  = 0.01). There were no significant main effects on verbatim comprehension or physical activity intentions and no moderation by sex, race/ethnicity, education, numeracy, or graph literacy ( P  > 0.05). Sequential mediation analyses revealed a small beneficial indirect effect of risk ladder versus list on intentions through gist comprehension and then through perceived risk ( b IndirectEffect  = 0.02, 95% confidence interval: 0.00, 0.04).
CONCLUSION


Risk ladders can communicate the gist meaning of multiple pieces of risk information to individuals from many sociodemographic backgrounds and with varying levels of facility with numbers and graphs.",2020,"There were no significant main effects on verbatim comprehension or physical activity intentions and no moderation by sex, race/ethnicity, education, numeracy, or graph literacy ( P  > 0.05).","['Our analytic sample ( N  = 372) included 41.3% individuals from underrepresented racial/ethnic backgrounds, 15.9% with vocational-technical training or less, 84.7% women, 43.8% aged 50 to 64 y, and 71.8% who were overweight/obese', '500 participants with <150 min weekly of physical activity from community settings']",[],"['verbatim comprehension or physical activity intentions and no moderation by sex, race/ethnicity, education, numeracy, or graph literacy', 'gist comprehension', 'risk assessments for diabetes, heart disease, stroke, colon cancer, and breast cancer']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",500.0,0.0321693,"There were no significant main effects on verbatim comprehension or physical activity intentions and no moderation by sex, race/ethnicity, education, numeracy, or graph literacy ( P  > 0.05).","[{'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Waters', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Maki', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ackermann', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Carter', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Hank', 'Initials': 'H', 'LastName': 'Dart', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Bowen', 'Affiliation': 'University of Washington, Merced, CA, USA.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Cameron', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University in St. Louis, Saint Louis, MO, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20968070']
1531,33106162,"Effects of whole body vibration with exercise therapy versus exercise therapy alone on flexibility, vertical jump height, agility and pain in athletes with patellofemoral pain: a randomized clinical trial.","BACKGROUND


Patellofemoral pain (PFP) is the most prevalent orthopedic problem in active young adults. Due to its multifactorial etiology, a variety of therapeutic measures have been adopted to treat PFP, including exercise therapy, electrotherapy, and manual therapy. It has also been suggested that whole body vibration (WBV) can improve neuromuscular function in persons with knee problems. The aim of the present study was to evaluate the effects of adding WBV to routine exercise programs on flexibility, vertical jump height, agility and pain in athletes with PFP.
METHODS


Twenty-four male athletes with PFP were randomized into two groups of WBV + exercise (n = 12) or exercise only (n = 12). Participants received their interventions during 4 consecutive weeks (12 sessions). Pain intensity, flexibility and agility were assessed respectively as score on a numerical rating scale, the sit-and-reach test, and a modified T-test, and vertical jump height was measured to the nearest centimeter. The tests were done before and after the interventions, and the results were compared between the two groups. Independent t-tests and paired t-tests were used for between- and within-group comparisons, respectively.
RESULTS


After the interventions, all variables for vertical jump height, flexibility, agility and pain intensity improved significantly in both groups (p < 0.05). The flexibility test showed significantly greater improvement in the WBV + exercise group (p<0.001), whereas for vertical jump height, agility and pain intensity, there were no statistically significant differences between groups (p>0.05).
CONCLUSIONS


The present findings showed that exercise therapy with and without WBV can significantly decrease pain and increase agility, vertical jump height and flexibility in athletes with PFP. Adding WBV to routine exercise therapy, however, can augment the effects of the latter on flexibility.
TRIAL REGISTRATION


IRCT, IRCT20090831002391N39. Registered 7 February 2018, https://en.irct.ir/search/result?query=IRCT20090831002391N39 .",2020,"After the interventions, all variables for vertical jump height, flexibility, agility and pain intensity improved significantly in both groups (p < 0.05).","['Twenty-four male athletes with PFP', 'athletes with patellofemoral pain', 'athletes with PFP', 'persons with knee problems', 'active young adults']","['WBV\u2009+\u2009exercise (n\u2009=\u200912) or exercise', 'exercise therapy with and without WBV', 'whole body vibration with exercise therapy versus exercise therapy alone']","['vertical jump height, flexibility, agility and pain intensity', 'numerical rating scale, the sit-and-reach test, and a modified T-test, and vertical jump height', 'flexibility, vertical jump height, agility and pain', 'Pain intensity, flexibility and agility', 'neuromuscular function', 'pain and increase agility, vertical jump height and flexibility', 'vertical jump height, agility and pain intensity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0555979', 'cui_str': 'Problem knee'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",24.0,0.0449693,"After the interventions, all variables for vertical jump height, flexibility, agility and pain intensity improved significantly in both groups (p < 0.05).","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Rasti', 'Affiliation': 'Student Research Committee, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rojhani-Shirazi', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. rojhaniz@sums.ac.ir.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Ebrahimi', 'Affiliation': 'Student Research Committee, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sobhan', 'Affiliation': 'Department of Orthopedic Surgery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03732-1']
1532,33086749,Safety and Stability of Pulmonary Function in Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA.,"Two randomized, placebo-controlled studies evaluated the pulmonary function safety of onabotulinumtoxinA (onabotA) for treatment of upper and/or lower limb spasticity. Patients with stable baseline respiratory status received one or two treatments with placebo, 240 U, or 360 U of onabotA. Pulmonary function tests, adverse events, and efficacy were measured at least every 6 weeks for 18 weeks (Study 1) or 30 weeks (Study 2). Study 1 enrolled 109 patients ( n  = 36-37/group) and Study 2 enrolled 155 patients ( n  = 48-54/group). Mean baseline forced vital capacity (FVC) was 76-78% of predicted per group in Study 1 and 71% of predicted per group in Study 2. In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3 (240 U -57 mL vs. placebo +110 mL) and 12 (360 U -6 mL vs. +167 mL placebo). In Study 2, change from baseline FVC values were significantly decreased in the 360 U group vs. placebo at weeks 6 (-78 mL vs. +49 mL placebo), 13 (-60 mL vs. +119 mL placebo), 18 (-128 mL vs. +80 mL placebo), and 24 (-82 mL vs. +149 mL placebo). Individual pulmonary function-related adverse events were not correlated with PFT decreases. The most frequent pulmonary-related adverse events were nasopharyngitis (Study 1) and upper respiratory tract infection (Study 2). Ashworth scores were significantly improved at multiple time points in both studies. Injection of onabotA for spasticity in patients with decreased pulmonary function, at single and repeated doses of up to 360 U, was associated with small but statistically significant decreases in FVC or forced expiratory volume 1 s (FEV1) (>12% and 200 mL) that were subclinical and not correlated with any adverse clinical pulmonary events.",2020,"In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3","['Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA', 'Study 1 enrolled 109 patients ( n  = 36-37/group) and Study 2 enrolled 155 patients ( n  = 48-54/group', 'upper and/or lower limb spasticity', 'Patients with stable baseline respiratory status']","['placebo', 'onabotulinumtoxinA (onabotA']","['baseline FVC values', 'pulmonary function', 'Individual pulmonary function-related adverse events', 'Safety and Stability of Pulmonary Function', 'Mean baseline forced vital capacity (FVC', 'FVC or forced expiratory volume 1 s (FEV1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",,0.315781,"In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3","[{'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Ayyoub', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA 90242, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'Department of Neurology, University of California, Sacramento, CA 95817, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Neurology, Jagiellonian University, 31-007 Krakow, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schoene', 'Affiliation': 'Sound Physicians, San Francisco, CA 95116, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stringer', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA 90502, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Boodhoo', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yushmanova', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Dimitrova', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}]",Toxins,['10.3390/toxins12100661']
1533,33087047,The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial.,"BACKGROUND


Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.
METHODS


This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)-four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients' demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.
RESULTS


Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001-0.815]; P = 0.042).
CONCLUSIONS


Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.
TRIAL REGISTRATION


A study protocol was registered at the Iranian Registry of Clinical Trials ( www.IRCT.ir ), number IRCT20200501047259N1 . It was registered retrospectively on May 17th, 2020.",2020,"Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups.","['patients with severe COVID-19 infection', 'severe coronavirus disease 2019', 'Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments']","['IVIg (human)-four vials daily', 'placebo', 'intravenous immunoglobulin gamma', 'intravenous immunoglobulin (IVIg']","['mortality rate', 'hospital mortality rate', 'occurrence of in-hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",59.0,0.545188,"Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups.","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Gharebaghi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Nejadrahim', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyed Jalil', 'Initials': 'SJ', 'LastName': 'Mousavi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyyed-Reza', 'Initials': 'SR', 'LastName': 'Sadat-Ebrahimi', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Sadatr@tbzmed.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Cardiology, Urmia University of Medical Sciences, Urmia, Iran. hajizadh.reza@gmail.com.'}]",BMC infectious diseases,['10.1186/s12879-020-05507-4']
1534,33087377,Brief compression-only cardiopulmonary resuscitation and automated external defibrillator course for secondary school students: a multischool feasibility study.,"OBJECTIVES


This study assessed the feasibility and preliminary efficacy of a 2-hour compression-only cardiopulmonary resuscitation and automated external defibrillator (CO-CPRAED) course in secondary school students.
DESIGN


Prospective pre-post feasibility study.
SETTING AND PARTICIPANTS


128 students (12-15 years old) without prior basic life support (BLS) training at four secondary schools in Hong Kong. All students were followed up at 3 months after training.
INTERVENTIONS


Emergency medicine-trained nurse and physicians taught the 2-hour CO-CPRAED course using the American Heart Association 'CPR in School Training Kit' programme. Students were trained in groups up to 40 students/session, with an instructor to student ratio not exceeding 1:10. To practise hands-on compressions, the manikin to student ratio was 1:1. For a simulated cardiac arrest, the manikin and AED to student ratio was 1:10.
PRIMARY AND SECONDARY OUTCOMES


CPR and AED knowledge, attitude statements towards bystander CPR and AED, quality of BLS performance skills during training and at 3 months.
RESULTS


Some students (46%) knew how deep to push on an adult chest when doing CO-CPR before training. The course was associated with an increase in knowledge score (pretraining 55%, post-training 93%; adjusted mean difference (MD) 38%, 95% CI 33% to 43%; p<0.001). Most students (68%) thought that CPR education in senior secondary school was essential before training. The students had a very positive attitude towards CPR; no change in the mean (SD) attitude score out of 30 over time (pretraining 27.2 (2.5), post-training 27.6 (2.7); adjusted MD 0.5, 95% CI -0.1 to 1.0; p=0.132). Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
CONCLUSIONS


The results demonstrate the feasibility of scaling up the number of secondary schools trained in a brief CO-CPRAED course within the local school curriculum.",2020,"Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
","['128 students (12-15 years old) without prior basic life support', 'secondary school students']","[""Emergency medicine-trained nurse and physicians taught the 2-hour CO-CPRAED course using the American Heart Association 'CPR in School Training Kit' programme"", 'Brief compression-only cardiopulmonary resuscitation and automated external defibrillator course', '2-hour compression-only cardiopulmonary resuscitation and automated external defibrillator (CO-CPRAED']","['CPR and AED knowledge, attitude statements towards bystander CPR and AED, quality of BLS performance skills', 'mean (SD) attitude score', 'knowledge score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",128.0,0.0220888,"Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
","[{'ForeName': 'Kit Ying', 'Initials': 'KY', 'LastName': 'So', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Hiu Fai', 'Initials': 'HF', 'LastName': 'Ko', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Cindy Sin Yui', 'Initials': 'CSY', 'LastName': 'Tsui', 'Affiliation': 'Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Chi Yeung', 'Initials': 'CY', 'LastName': 'Yeung', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yee Ching', 'Initials': 'YC', 'LastName': 'Chu', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Veronica Ka Wai', 'Initials': 'VKW', 'LastName': 'Lai', 'Affiliation': 'Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China annalee@cuhk.edu.hk.'}]",BMJ open,['10.1136/bmjopen-2020-040469']
1535,33089408,Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ) in glioma patients in China.,"BACKGROUND


Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal ®  capsules administered to brain tumor patients.
STUDY DESIGN


An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/m 2  daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/m 2  dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, Temodal ®  was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of Temodal ®  and spread equally over days 3-5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC  0-∞ ) fell within the equivalence boundary of 80-125%.
RESULTS


Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for C max  (91.08%, 106.18%), AUC 0-t  (98.62%,102.18%), and AUC 0-∞  (98.65%, 102.21%) was well within the 80%-125% range for the 20-mg capsule, as was the C max  (90.49%, 113.32%), AUC 0-t  (99.89%, 104.63%) and AUC 0-∞  (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients.
CONCLUSION


It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to Temodal ®  capsules of the same strength under fasting conditions.
TRIAL REGISTRATION


https://www.chinadrugtrials.org.cn/index.html , CTR2017 0122.",2020,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","['Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients', 'glioma patients in China', 'patients with primary brain tumors']","['Temozolomide', 'generic temozolomide', 'TOZ309', '20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ']","['Adverse events', 'adverse events', 'no mortality', 'severe adverse events', 'adverse effect (life-threatening seizures', 'geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC  0-∞ ) fell', 'AUC 0-t', 'geometric means ratio for C max']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1248697', 'cui_str': 'temozolomide Oral Capsule'}, {'cui': 'C4082706', 'cui_str': 'Temodal'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0671231,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","[{'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Qingtang', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xinxia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Guoguang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. ggzhao@xwhosp.org.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. zhanglan@xwhosp.org.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04175-0']
1536,33091332,Development and validation of prognostic nomogram for lung cancer patients below the age of 45 years.,"This study aimed to establish a nomogram for the prognostic prediction of patients with early-onset lung cancer (EOLC) in both overall survival (OS) and cancer-specific survival (CSS). We retrieved EOLC patients diagnosed between 2004 and 2015 from the Surveillance, Epidemiology, and End Results (SEER) database and further divided them into training and validation sets randomly. The prognostic nomogram for predicting 3-, 5- and 10-years OS and CSS was established based on the relative clinical variables determined by the multivariate Cox analysis results. Furthermore, the predictive performance of the nomogram was assessed by concordance index (C-index), calibration curve, receiver operating characteristic (ROC) curve and decision curve analysis (DCA) curve. A total of 1,822 EOLC patients were selected and randomized into a training cohort (1,275, 70%) and a validation cohort (547, 30%). The nomograms were established based on the statistical results of Cox analysis. In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816). Significant agreement in the calibration curves was noticed in the nomogram models. The results of ROC and DCA indicated nomograms possessed better predict performance compared with TNM-stage and SEER-stage. Furthermore, the areas under the curve (AUC) of the nomogram for OS and CSS prediction in ROC analysis were 0.766 (95%CI:0.745-0.787) and 0.782 (95%CI:0.760-0.804) respectively. In conclusion, the prognostic nomogram provided an accurate prediction of 3-, 5-, and 10-year OS and CSS of EOLC patients which contributed clinicians to optimize individualized treatment plans.",2020,"In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816).","['1,822 EOLC patients', 'EOLC patients diagnosed between 2004 and 2015 from the Surveillance, Epidemiology, and End Results (SEER) database and further divided them into training and validation sets randomly', 'lung cancer patients below the age of 45 years', 'patients with early-onset lung cancer (EOLC']",[],"['concordance index (C-index), calibration curve, receiver operating characteristic (ROC) curve and decision curve analysis (DCA) curve', 'overall survival (OS) and cancer-specific survival (CSS', 'calibration curves']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",1822.0,0.0552124,"In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816).","[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Medicine, Funan County People's Hospital, Anhui, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory Medicine, Funan County People's Hospital, Anhui, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Punan Hospital of Pudong District, Shanghai, China.'}, {'ForeName': 'Tongjia', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui, China.'}, {'ForeName': 'Qikui', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Chest Surgery, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Tuberculosis, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhu', 'Affiliation': 'Department of Respiratory Medicine, The Second Affiliated Hospital of Xuzhou Medical University, Jiangsu China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Aulmonary and Endoscopy Center, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, Anhui Cancer Hospital, Anhui, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Department of Respiratory Medicine, The Fourth Affiliated Hospital of Anhui Medical University, Anhui, China.'}, {'ForeName': 'Kaixin', 'Initials': 'K', 'LastName': 'Qu', 'Affiliation': ""Department of Respiratory Medicine, Funan County People's Hospital, Anhui, China.""}]",Bosnian journal of basic medical sciences,['10.17305/bjbms.2020.5079']
1537,33091438,The placebo effect in breath holding: a preliminary behavioral investigation.,"PURPOSE


This study seeks to evaluate effects of expectations and conditioning on dry breath holding.
METHODS


Sixty healthy volunteers were subdivided into 3 groups and were tested across 4 breath holding trials. Participants of the Control group (C) did not undergo any manipulation. Participants of the placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2) along with opposite information that this would enhance or worsen their breath holding time, respectively. Opposite conditioning paradigms based on false visual feedback were employed to reinforce participants' positive (placebo) and negative (nocebo) beliefs.
RESULTS


The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001). Additionally, in the last trial the P group showed a greater decrease in peripheral oxygen saturation (SpO2) as compared to the C group (p = 0.04) and the N group (p = 0.001). Heart rate (HR) was accelerated in the N group during breath holding (in comparison to the P group [p = 0.04] and C group [p = 0.04]).
CONCLUSIONS


Psychological components can affect behavioral and physiological parameters in breath holding. This study may inform future research about the role of placebo and nocebo effects for conditions in which critical functions are at play.",2020,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,['Sixty healthy volunteers'],"['placebo', 'placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2']","['breath holding time', 'longest breath holding time', 'peripheral oxygen saturation (SpO2', 'Heart rate (HR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.145215,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Piedimonte', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barbiani', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy; Medicine & Physiology of Hypoxia, Plateau Rosa Laboratories, Breuil-Cervinia, Italy, Zermatt, Switzerland.'}, {'ForeName': 'Denisa Adina', 'Initials': 'DA', 'LastName': 'Zamfira', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Carlino', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: elisa.carlino@unito.it.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135434']
1538,33091681,Concreteness of thoughts and images during suppression and expression of worry.,"The avoidance theory of worry (Borkovec, Alcaine, & Behar, 2004) posits that the verbal-linguistic (versus imagery-based) nature of worry elicits abstract (versus concrete) processing, which inhibits affective responding and generates a host of negative consequences. Although suppression of worrisome thinking is maladaptive (Purdon, 1999), expression of worry using vivid imagery may increase concreteness of worrisome thinking and facilitate more adaptive emotional responding. The present study examined whether the valence, content, and expression of mentation impacts concreteness of thought. Participants (N = 62) were randomly assigned to verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics. Participants were also randomly assigned to engage in a 5-min period of suppressing or expressing the target stimuli before engaging in 5-min of freely expressing the targets. Verbalizations of mental content were coded for level of abstractness/concreteness. For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness. In addition, for neutral (but not worrisome) stimuli, an initial period of suppression was associated with increased concreteness during subsequent expression. Imagery-based mentation about worrisome stimuli may not enhance concreteness; moreover, unlike suppression of neutral stimuli, suppression of worrisome stimuli may maintain, rather than ameliorate, abstractness of thought.",2020,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.",['Participants (N\xa0=\xa062'],"['verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics', 'Imagery-based mentation about worrisome stimuli']",['Concreteness of thoughts and images during suppression and expression of worry'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",62.0,0.0172364,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Jendrusina', 'Affiliation': 'University of Illinois at Chicago, USA; VA Ann Arbor Healthcare System, USA. Electronic address: alexanderjendrusina@gmail.com.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'University of Illinois at Chicago, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Nahin', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Legrand', 'Affiliation': 'University of Vermont, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'City University of New York - Hunter College, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103754']
1539,33091687,Facial emotion recognition in borderline patients is unaffected by acute psychosocial stress.,"Borderline Personality Disorder (BPD) is characterized by difficulties in social cognition and social interactions, which exacerbate under stress. A previous study found better facial emotion recognition (FER) in patients with personality disorders and healthy controls (HC) after stress. We recently reported that emotional empathy scores, i.e. the emotional response to another person's emotional state, were significantly lower in BPD patients than in HC after psychosocial stress. Cognitive empathy scores remained unaltered. The present study aims to further investigate the effect of psychosocial stress induced by the Trier Social Stress Test (TSST) on FER as part of social cognition in patients with BPD. We randomized 43 women with BPD and 46 female HC to either the TSST or a placebo condition. Afterwards, participants were asked in an emotion recognition test to identify emotions in faces showing anger or sadness at low and high intensity. Both groups recognized emotions better at high intensity compared with low intensity. There was no effect of stress on FER performance and we found no difference between groups. This is in line with prior research on social cognition in BPD patients demonstrating that the ability to understand another person's perspective might be unaffected by acute stress.",2020,Cognitive empathy scores remained unaltered.,"['43 women with BPD and 46 female HC to either the TSST or a placebo condition', 'borderline patients', 'patients with personality disorders and healthy controls (HC) after stress', 'patients with BPD', 'Borderline Personality Disorder (BPD', 'BPD patients']",['Trier Social Stress Test (TSST'],"['Cognitive empathy scores', 'FER performance', 'Facial emotion recognition', 'facial emotion recognition (FER']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",43.0,0.0136793,Cognitive empathy scores remained unaltered.,"[{'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Graumann', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: katja.wingenfeld@charite.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.007']
1540,33091706,Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.,"STUDY OBJECTIVE


The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.
DESIGN


Prospective, randomized, open-label clinical trial.
SETTING


University-affiliated hospital.
PATIENTS


Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.
INTERVENTIONS


Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.
MEASUREMENTS


All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
MAIN RESULTS


There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.
CONCLUSION


We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.",2020,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","['Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery', 'elderly patients undergoing major non-cardiac surgery', 'elderly surgical patients', 'University-affiliated hospital', 'Elderly patients undergoing non-cardiac major surgery']","['methylene blue (MB', 'Methylene blue', 'intravenous infusion of 2\xa0mg/kg\xa0MB within 60\xa0min immediately after anesthetic induction, or control group (n\xa0=\xa0124), who receiving equal volume saline', 'MB']","['POD/POCD and levels of SOD or HCY', 'incidences of POD and early POCD', 'incidence of early POCD', 'postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD', 'incidence of POD', 'delirium and neuropsychological batteries', 'adverse events', 'perioperative adverse events', 'Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY', 'early postoperative cognitive disorders']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",248.0,0.0572685,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","[{'ForeName': 'Yixu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China.'}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University,Shanghai 200032, PR China. Electronic address: snapzhang@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110108']
1541,33091760,The social curse: Evidence for a moderating effect of shared social identity on contagious stress reactions.,"Contagious stress describes the transmission of a stress response from a distressed individual (target) to an uninvolved observer. Building on social identity theory, we hypothesize that a shared social identity between the observer and the target as compared to a personal identity increases the likelihood of contagious endocrine and psychological stress responses. Participants underwent the experiment in groups of four or five individuals. After experimentally inducing either a shared social identity or a personal identity, one participant in each group (N target  = 27) was randomly chosen to undergo the Trier Social Stress Test (TSST), while being observed by the rest of the group (N observer  = 89). Salivary cortisol and psychological stress responses were assessed repeatedly during the experiment. As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %). No effect of our manipulation on psychological stress responses was found. We also tested whether observers' trait empathy moderates contagious stress and found no support for this moderation.",2020,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).",[],['Trier Social Stress Test (TSST'],"['Salivary cortisol and psychological stress responses', 'psychological stress responses', 'likelihood of cortisol stress reactions']",[],"[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}]",,0.00992355,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).","[{'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Schury', 'Affiliation': 'Justus-Liebig-University Giessen, Germany. Electronic address: Valerie.A.Schury@psychol.uni-giessen.de.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'University of Vienna, Austria.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Häusser', 'Affiliation': 'Justus-Liebig-University Giessen, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104896']
1542,33092420,Delayed cord clamping for prevention of intraventricular hemorrhage in preterm neonates: a randomized control trial.,"BACKGROUND


Intraventricular hemorrhage (IVH) is a common condition in preterm neonates and is responsible for substantial adverse neurodevelopmental outcome in preterm neonates. Prevention of IVH is an important intervention for better neurological outcome in these preterm neonates.
AIMS AND OBJECTIVE


This study aimed to determine whether delayed cord clamping (DCC) was superior to immediate cord clamping (ICC) for the prevention of IVH in preterm neonates.
PATIENTS AND METHODS


In this two centered prospective double-blind randomized controlled trial, eligible neonates with gestational age from 26 to 34 weeks were randomized to receive either ICC (cord clamped in 10-15 s) or DCC (cord clamped in 30-45 s) groups. The grading and severity of IVH were evaluated by cranial ultrasound scan done on the 3-4th and 7-10th days after birth.
RESULTS


Among the 148 enrolled neonates, 79 were in the ICC group and 69 were in the DCC group. There was no difference in maternal and neonatal baseline characteristics except the neonates in the DCC group weighed more (ICC 1528.77 ± 365.5 g vs. DCC 1658.11 ± 419.52 g;  p  = .047) at birth. There was no significant difference in the incidence of any grade of IVH in both groups (ICC 12.8% vs. DCC 14.5%;  p  = .745). There was a significantly higher incidence of grade I IVH (ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group. The incidence of grade II IVH (ICC 5.1% vs. DCC 0%;  p  = .123); grade III IVH (ICC 3.8% vs. DCC 1.4%;  p  = .623); and grade IV IVH (ICC 1.3% vs. DCC 0%;  p >.999) were comparable between the two groups. The incidence of a significant IVH (grades II, III, and IV) was significantly less in the DCC group (ICC 10.1% vs. DCC 1.4%,  p  = .036). The mean initial hemoglobin levels were significantly higher in neonates enrolled in DCC (15.41 ± 2.1 vs. 16.46 ± 2.45 g/dL;  p   =  .007). There was a significant reduction in the number of days of hospital stay (ICC 18.78 ± 15.42 vs. DCC 13.21 ± 16.16;  p  = .002). There was no difference in initial hematocrit, platelet count, maximum bilirubin level, and Apgar score ( p >.05).
CONCLUSIONS


Although there was no reduction in any grade of IVH, the incidence of significant IVH (grades II, III, and IV) was significantly decreased with the use of DCC in preterm neonates. Delayed cord clamping also resulted in a significant increase in birth weight, higher hemoglobin levels, and shorter hospital stays without any increase in the risks of hyper-bilirubinemia, low Apgar score, and neonatal mortality.
TRIAL REGISTRY


IRCT2014031116936N1, https://www.irct.ir/trial/15707.",2020,ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group.,"['preterm neonates', 'eligible neonates with gestational age from 26 to 34\xa0weeks', '148 enrolled neonates, 79 were in the ICC group and 69 were in the DCC group']","['delayed cord clamping (DCC', 'immediate cord clamping (ICC', 'Delayed cord clamping', 'ICC (cord clamped in 10-15\u2009s) or DCC', 'DCC']","['grade III IVH', 'incidence of grade II IVH', 'grade I IVH ', 'incidence of any grade of IVH', 'initial hematocrit, platelet count, maximum bilirubin level, and Apgar score', 'incidence of a significant IVH (grades II, III, and IV', 'grading and severity of IVH', 'mean initial hemoglobin levels', 'grade of IVH, the incidence of significant IVH (grades II, III, and IV', 'risks of hyper-bilirubinemia, low Apgar score, and neonatal mortality', 'number of days of hospital stay', 'grade IV IVH', 'birth weight, higher hemoglobin levels, and shorter hospital stays']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0949144', 'cui_str': 'Intraventricular haemorrhage grade III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0949143', 'cui_str': 'Intraventricular haemorrhage grade II'}, {'cui': 'C0949142', 'cui_str': 'Intraventricular haemorrhage grade I'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0949145', 'cui_str': 'Intraventricular haemorrhage grade IV'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",148.0,0.0966247,ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group.,"[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Hemmati', 'Affiliation': 'Department of Pediatrics, School of Medicine, Neonatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Neonatology, National Institute of Medical Science, Jaipur, India.'}, {'ForeName': 'Bahia', 'Initials': 'B', 'LastName': 'Namavar Jahromi', 'Affiliation': 'Department of OB-GYN, School of Medicine, Maternal-Fetal Medicine Research Center, Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Salarian', 'Affiliation': 'Department of Pediatrics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Farahbakhsh', 'Affiliation': ""Department of Pulmonology, Pediatric Department, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1836148']
1543,33092565,"Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia.","BACKGROUND


Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia.
METHODS


A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions.
RESULTS


Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
CONCLUSIONS


Both the combined MWH +  & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women's use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated.
TRIAL REGISTRATION


The trial was retrospectively registered on the Clinical Trials website ( https://clinicaltrials.gov ) on 3rd October 2017. The trial identifier is NCT03299491 .",2020,"Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
","['Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12\u2009months prior to being surveyed were eligible for interview', 'Data from 24 PHCUs and 7593 women', 'Twenty-four primary health care units (PHCUs', 'Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities', 'institutional births in Jimma Zone, Ethiopia']","['MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care', 'upgraded maternity waiting homes and local leader training', 'combined MWH +  & leader training', 'functional MWHs combined with community mobilization by trained local leaders']","['proportion of institutional births', 'institutional births']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0419373', 'cui_str': 'Livebirth'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337490', 'cui_str': 'Motherhood'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}]",7593.0,0.107904,"Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
","[{'ForeName': 'Jaameeta', 'Initials': 'J', 'LastName': 'Kurji', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada. jkurj022@uottawa.ca.'}, {'ForeName': 'Lakew Abebe', 'Initials': 'LA', 'LastName': 'Gebretsadik', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Muluemebet Abera', 'Initials': 'MA', 'LastName': 'Wordofa', 'Affiliation': 'Department of Population & Family Health, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Morankar', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kunuz Haji', 'Initials': 'KH', 'LastName': 'Bedru', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Gebeyehu', 'Initials': 'G', 'LastName': 'Bulcha', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bergen', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}, {'ForeName': 'Getachew', 'Initials': 'G', 'LastName': 'Kiros', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Yisalemush', 'Initials': 'Y', 'LastName': 'Asefa', 'Affiliation': 'Department of Health Economics, Management & Policy, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Shifera', 'Initials': 'S', 'LastName': 'Asfaw', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Abebe', 'Initials': 'A', 'LastName': 'Mamo', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Erko', 'Initials': 'E', 'LastName': 'Endale', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ottawa Hospital Research Institute General Campus, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Labonte', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute Civic Campus, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Manisha A', 'Initials': 'MA', 'LastName': 'Kulkarni', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}]",BMC public health,['10.1186/s12889-020-09692-4']
1544,33092583,The effectiveness of the combined problem-based learning (PBL) and case-based learning (CBL) teaching method in the clinical practical teaching of thyroid disease.,"BACKGROUND


This study aimed to evaluate the effectiveness and efficiency of PBL-CBL combined teaching in thyroid surgery and make observations from the students' perspectives, based on their satisfaction with the learning process.
METHODS


We prospectively enrolled 354 fourth-year students majoring in clinical medicine, along with 232 residents, from September 2014 to June 2019. These participants were randomly allocated into either the combined PBL-CBL teaching group or the traditional lecture-based classroom group to attend a course about thyroid nodules. Both pre- and post-class quizzes were conducted. An anonymous questionnaire was also administered to both groups to evaluate the students' perceptions and experiences. We compared the two teaching methods among all the students as well as with the fourth-year students and residents in subgroups.
RESULTS


The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001). After class, in the PBL-CBL group, the mean total quiz score and the basic knowledge and case analysis scores increased significantly (P < 0.001). The PBL-CBL group's performance improvement was significantly higher than the traditional group's (increasing from 52.76 to 70.51 vs. from 67.03 to 71.97). Furthermore, the scores for learning motivation, understanding, student-teacher interaction, the final examination, communication skills, clinical thinking skills, self-learning skills, teamwork skills, and knowledge absorption, as measured by the survey, were significantly higher in the PBL-CBL group than in the traditional group (P < 0.001). Meanwhile, the survey scores representing the amount of students' free time the course consumed were significantly lower in the PBL-CBL group than in the traditional group (P < 0.001).
CONCLUSIONS


PBL combined with CBL may be an effective method for improving medical students' and residents' performance and enhancing their clinical skills.",2020,"The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001).","['enrolled 354 fourth-year students majoring in clinical medicine, along with 232 residents, from September 2014 to June 2019', 'students as well as with the fourth-year students and residents in subgroups']","['PBL-CBL combined teaching', 'combined problem-based learning (PBL) and case-based learning (CBL) teaching method', 'combined PBL-CBL teaching group or the traditional lecture-based classroom group to attend a course about thyroid nodules', 'PBL-CBL', 'PBL combined with CBL']","['pre-class quiz scores', 'mean total quiz score and the basic knowledge and case analysis scores', 'scores for learning motivation, understanding, student-teacher interaction, the final examination, communication skills, clinical thinking skills, self-learning skills, teamwork skills, and knowledge absorption']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008964', 'cui_str': 'Medicine, Clinical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C3472614', 'cui_str': 'Plasmablastic lymphoma'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040137', 'cui_str': 'Thyroid nodule'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4279942', 'cui_str': 'Thinking Skills'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.0227956,"The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001).","[{'ForeName': 'Wanjun', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Linye', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Wenyi', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Jingqiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Su', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Transplant Engineering and Immunology, MOH; West China-Washington Mitochondria and Metabolism Research Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, 610041, NO, China. nankai1989@foxmail.com.'}]",BMC medical education,['10.1186/s12909-020-02306-y']
1545,33093056,Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).,"OBJECTIVE


To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.
DESIGN


Open label, parallel arm, phase II, multicentre, randomised controlled trial.
SETTING


39 public and private hospitals across India.
PARTICIPANTS


464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).
INTERVENTIONS


Participants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.
MAIN OUTCOME MEASURE


Composite of progression to severe disease (PaO 2 /FiO 2  <100 mm Hg) or all cause mortality at 28 days post-enrolment.
RESULTS


Progression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval -0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).
CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.
TRIAL REGISTRATION


Clinical Trial Registry of India CTRI/2020/04/024775.",2020,"CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","['moderate covid-19 in adults in India', '464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to', 'moderate coronavirus disease 2019 (covid-19) in adults in India', '39 public and private hospitals across India']","['convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm', 'convalescent plasma']","['cause mortality', 'presence and levels of neutralising antibodies']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}]",464.0,0.327069,"CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India aparna.sinha.deb@icmr.gov.in.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Pranab', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Bhatnagar', 'Affiliation': 'ICMR School of Public Health, Indian Council of Medical Research - National Institute of Epidemiology, Chennai, Tamil, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3939']
1546,33093216,Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials.,"OBJECTIVE


To confirm that metformin prevents flares in patients with SLE with low disease activity, we performed a post hoc analysis combining our previous two randomised trials.
METHODS


Post hoc analyses were performed on data from the open-labelled proof-of-concept trial (n=113, ChiCTR-TRC-12002419) and placebo-controlled 'Met Lupus' trial (n=140, NCT02741960) comparing the efficacy of metformin versus placebo/nil add-on to standard therapy in patients with SLE with low disease activity (SELENA-SLEDAI ≤4). The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up. A subgroup analysis was performed.
RESULTS


Overall, 201 eligible patients were included, with 99 allocated to metformin group and 102 allocated to the placebo/nil group. By 12 months of follow-up, 21 patients (21.2%) flared in the metformin group, as compared with 36 (35.3%) in the placebo/nil group (p=0.027, risk ratio=0.68, 95% CI 0.46 to 0.96). Subgroup analysis showed that patients with negative anti-dsDNA antibody and normal complement at baseline, and a disease duration <5 years with concomitant use of hydroxychloroquine had a better response to metformin.
CONCLUSION


Post hoc pooled analyses suggested that metformin reduced subsequent disease flares in patients with SLE with low disease activity, especially for serologically quiescent patients.",2020,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"['201 eligible patients were included, with 99 allocated to', 'patients with SLE with low disease activity', 'patients with SLE with low disease activity (SELENA-SLEDAI ≤4', 'patients with systemic lupus erythematosus', 'patients with SLE']","['hydroxychloroquine', 'metformin versus placebo/nil add-on to standard therapy', 'metformin', 'placebo', 'placebo/nil group']","['disease flares', 'subsequent disease flares', 'SELENA-SLEDAI Flare Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442734', 'cui_str': 'Nil'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",201.0,0.230682,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shikai', 'Initials': 'S', 'LastName': 'Geng', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiting', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Morel', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China ye_shuang2000@163.com.'}]",Lupus science & medicine,['10.1136/lupus-2020-000429']
1547,33106174,NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial.,"BACKGROUND


Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume.
METHODS


NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI.
DISCUSSION


We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04050501 . Registered on 8 August 2019.",2020,We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery.,"['One hundred fifty patients', 'acute Ischemic Stroke (NOVIS']","['non-invasive cervical VNS (nVNS', 'NOn-invasive Vagus nerve stimulation']","['penumbral recovery and limit final infarct volume', 'final infarct volume on day 5 assessed with MRI']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",150.0,0.147487,We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'van der Meij', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands. a.van_der_meij@lumc.nl.'}, {'ForeName': 'Marianne A A', 'Initials': 'MAA', 'LastName': 'van Walderveen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nyika D', 'Initials': 'ND', 'LastName': 'Kruyt', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Erik W', 'Initials': 'EW', 'LastName': 'van Zwet', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marieke J H', 'Initials': 'MJH', 'LastName': 'Wermer', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.'}]",Trials,['10.1186/s13063-020-04794-1']
1548,33106180,"PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke-statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment.","RATIONALE


Aspiration, infections, and fever are common in the first days after stroke, especially in older patients. The occurrence of these complications has been associated with an increased risk of death or dependency.
AIMS AND DESIGN


PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke.
DISCUSSION


This statistical analysis plan provides a technical description of the statistical methodology and unpopulated tables and figures. The paper is written prior to data lock and unblinding of treatment allocation.
TRIAL REGISTRATION


ISRCTN registry ISRCTN82217627 . Registered on 22 September 2015. The trial was prospectively registered.",2020,"AIMS AND DESIGN


PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke.
","['older patients', 'elderly patients with acute Stroke-statistical analysis plan', 'elderly patients with acute Stroke (PRECIOUS', 'elderly patients with acute stroke']","['metoclopramide, ceftriaxone, paracetamol']",['functional outcome'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.155944,"AIMS AND DESIGN


PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke.
","[{'ForeName': 'Jeroen C', 'Initials': 'JC', 'LastName': 'de Jonge', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Woodhouse', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Reinink', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. H.B.vanderWorp@umcutrecht.nl.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04717-0']
1549,33106183,"An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial.","OBJECTIVES


We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease TRIAL DESIGN: This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial.
PARTICIPANTS


The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences.
INTERVENTION AND COMPARATOR


COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation.
MAIN OUTCOMES


Primary outcome: Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first.
SECONDARY OUTCOMES


mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving.
RANDOMIZATION


Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases.
BLINDING (MASKING)


The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra).
TRIAL STATUS


Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20 th  2020, and the end date was on September 4 th  2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization.
TRIAL REGISTRATION


This study was registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first.","['100 patients randomised', 'registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020', 'Eligible patients with confirmed SARS-Cov-2 infections', 'Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences', 'moderate to severe COVID-19', 'COVID-19 Confirmed Cases', ' 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital', 'The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission', '50 patients']","['lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels', 'lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen', 'Interferon beta-1a plus lopinavir/ritonavir (Kaletra', 'standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation', 'low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]",[],50.0,0.151389,"Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first.","[{'ForeName': 'Ilad', 'Initials': 'I', 'LastName': 'Alavi Darazam', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ilad13@yahoo.com.'}, {'ForeName': 'Firouze', 'Initials': 'F', 'LastName': 'Hatami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Rabiei', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Hajesmaeili', 'Affiliation': 'Anesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoosh', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Sina Naghibi', 'Initials': 'SSN', 'LastName': 'Irvani', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04812-2']
1550,33106185,"Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial.","BACKGROUND


Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN.
METHODS/DESIGN


This is a study protocol for a randomized, placebo-controlled clinical trial. A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12 weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients.
DISCUSSION


This trial may provide high-quality evidence for evaluating the efficacy and safety of MA treatment for DPN compared with SA treatment. Results of this study will be published in peer-reviewed journals.
TRIAL REGISTRATION


Chinese Clinical Trials Registry ChiCTR1800020444. First registered on 29 December 2018, retrospectively registered, http://www.chictr.org.cn/showproj.aspx?Proj=31063 .",2020,The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline.,"['First registered on 29 December 2018, retrospectively registered, http://www.chictr.org.cn/showproj.aspx?Proj=31063 ', 'diabetic peripheral neuropathy', '118 patients with DPN']","['Acupuncture', 'placebo', 'manual acupuncture (MA) versus sham acupuncture (SA', 'MA group or SA']","['efficacy and safety', 'peroneal motor nerve conduction velocity (peroneal MNCV', 'peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL', 'Masking effectiveness']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0429382', 'cui_str': 'Nerve action potential amplitude'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0457378', 'cui_str': 'Sensory nerve conduction velocity'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",118.0,0.590889,The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline.,"[{'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Long-Hua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Xuhui District, Shanghai, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Long-Hua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Xuhui District, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Long-Hua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Xuhui District, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'Long-Hua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Xuhui District, Shanghai, China. peijian99@yahoo.com.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China. sxy1@shutcm.edu.cn.'}]",Trials,['10.1186/s13063-020-04811-3']
1551,33106225,"The EURO SHOCK Trial: Design, Aims and Objectives.","AIMS


Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downwards spiral towards death, which becomes difficult to reverse.
METHODS AND RESULTS


The ""EURO SHOCK' trial will test the benefit or otherwise of mechanical cardiac support using veno-arterial extra-corporeal membrane oxygenation (VA-ECMO), initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomize 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or to standard pharmacotherapy alone. It will be conducted in 39 European centers. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating sub-studies will be undertaken.
CONCLUSIONS


The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI, improves mortality and morbidity.",2020,Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s.,"['patients with acute coronary syndromes (ACS', '428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early', '39 European centers']","['ECMO plus standard pharmacotherapy, or to standard pharmacotherapy alone']","['Mortality', 'mortality and morbidity', '30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",428.0,0.238425,Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s.,"[{'ForeName': 'Amerjeet Singh', 'Initials': 'AS', 'LastName': 'Banning', 'Affiliation': 'University of Leicester, University Hospitals of Leicester, Leicester Biomedical Research Centre, Leicester, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Adriaenssens', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': ''}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Distelmaier', 'Affiliation': ''}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Guagliumi', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Haine', 'Affiliation': ''}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': ''}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Myrmel', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vuylsteke', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': ''}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': ''}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Verheugt', 'Affiliation': ''}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Vrints', 'Affiliation': ''}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Gracey', 'Affiliation': ''}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Ferguson', 'Affiliation': ''}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bousfield', 'Affiliation': ''}, {'ForeName': 'Hakeem', 'Initials': 'H', 'LastName': 'Yusuff', 'Affiliation': ''}, {'ForeName': 'Cat', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-01076']
1552,33106354,Faecal microbiota transplantation halts progression of human new-onset type 1 diabetes in a randomised controlled trial.,"OBJECTIVE


Type 1 diabetes (T1D) is characterised by islet autoimmunity and beta cell destruction. A gut microbiota-immunological interplay is involved in the pathophysiology of T1D. We studied microbiota-mediated effects on disease progression in patients with type 1 diabetes using faecal microbiota transplantation (FMT).
DESIGN


Patients with recent-onset (<6 weeks) T1D (18-30 years of age) were randomised into two groups to receive three autologous or allogenic (healthy donor) FMTs over a period of 4 months. Our primary endpoint was preservation of stimulated C peptide release assessed by mixed-meal tests during 12 months. Secondary outcome parameters were changes in glycaemic control, fasting plasma metabolites, T cell autoimmunity, small intestinal gene expression profile and intestinal microbiota composition.
RESULTS


Stimulated C peptide levels were significantly preserved in the autologous FMT group (n=10 subjects) compared with healthy donor FMT group (n=10 subjects) at 12 months. Small intestinal  Prevotella  was inversely related to residual beta cell function (r=-0.55, p=0.02), whereas plasma metabolites 1-arachidonoyl-GPC and 1-myristoyl-2-arachidonoyl-GPC levels linearly correlated with residual beta cell preservation (rho=0.56, p=0.01 and rho=0.46, p=0.042, respectively). Finally, baseline CD4 +CXCR3+T cell counts, levels of small intestinal  Desulfovibrio piger  and CCL22 and CCL5 gene expression in duodenal biopsies predicted preserved beta cell function following FMT irrespective of donor characteristics.
CONCLUSION


FMT halts decline in endogenous insulin production in recently diagnosed patients with T1D in 12 months after disease onset. Several microbiota-derived plasma metabolites and bacterial strains were linked to preserved residual beta cell function. This study provides insight into the role of the intestinal gut microbiome in T1D.
TRIAL REGISTRATION NUMBER


NTR3697.",2020,"RESULTS


Stimulated C peptide levels were significantly preserved in the autologous FMT group (n=10 subjects) compared with healthy donor FMT group (n=10 subjects) at 12 months.","['Faecal microbiota transplantation halts progression of human new-onset type 1 diabetes', 'T1D (18-30 years of age', 'patients with type 1 diabetes using faecal microbiota transplantation (FMT', 'diagnosed patients with T1D in 12 months after disease onset', 'Patients with recent-onset (<6 weeks']","['healthy donor FMT', 'FMT', 'autologous FMT', 'three autologous or allogenic (healthy donor) FMTs']","['preservation of stimulated C peptide release assessed by mixed-meal tests', 'disease progression', 'endogenous insulin production', 'residual beta cell function', 'plasma metabolites 1-arachidonoyl-GPC and 1-myristoyl-2-arachidonoyl-GPC levels', 'changes in glycaemic control, fasting plasma metabolites, T cell autoimmunity, small intestinal gene expression profile and intestinal microbiota composition', 'baseline CD4 +CXCR3+T cell counts, levels of small intestinal  Desulfovibrio piger  and CCL22 and CCL5 gene expression']","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1415375', 'cui_str': 'Glycophorin D'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0315202', 'cui_str': 'Desulfovibrio piger'}, {'cui': 'C0674299', 'cui_str': 'CCL22 protein, human'}, {'cui': 'C1436337', 'cui_str': 'CCL5 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",,0.084021,"RESULTS


Stimulated C peptide levels were significantly preserved in the autologous FMT group (n=10 subjects) compared with healthy donor FMT group (n=10 subjects) at 12 months.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'de Groot', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Nicolic', 'Affiliation': 'Department of Immunology, LUMC, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellegrini', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Sordi', 'Affiliation': 'Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Imangaliyev', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Rampanelli', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Nordin', 'Initials': 'N', 'LastName': 'Hanssen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Attaye', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Bakker', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Duinkerken', 'Affiliation': 'Department of Immunology, LUMC, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'Department of Immunology, LUMC, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Prodan', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Evgeni', 'Initials': 'E', 'LastName': 'Levin', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Levels', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Bartjan', 'Initials': 'B', 'LastName': 'Potter van Loon', 'Affiliation': 'Internal Medicine, OLVG Location West, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'van Bon', 'Affiliation': 'Internal Medicine, Rijnstate, Arnhem, Gelderland, The Netherlands.'}, {'ForeName': 'Catherina', 'Initials': 'C', 'LastName': 'Brouwer', 'Affiliation': 'Internal Medicine, OLVG, Location Oost, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Sytze', 'Initials': 'S', 'LastName': 'van Dam', 'Affiliation': 'Internal Medicine, OLVG, Location Oost, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Simsek', 'Affiliation': 'Internal Medicine, North West Hospital Group, Alkmaar, Noord-Holland, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'van Raalte', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Stam', 'Affiliation': 'Internal Medicine, North West Hospital Group, Alkmaar, Noord-Holland, The Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Gerdes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Hoogma', 'Affiliation': 'Internal Medicine, Groene Hart Hospital, Gouda, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Diekman', 'Affiliation': 'Internal Medicine, Deventer Hospital, Deventer, Overijssel, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gerding', 'Affiliation': 'Internal Medicine, Deventer Hospital, Deventer, Overijssel, The Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Rustemeijer', 'Affiliation': 'Internal Medicine, Hospital Amstelland, Amstelveen, North Holland, The Netherlands.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'de Bakker', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Aeilko', 'Initials': 'A', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bergman', 'Affiliation': 'Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Holleman', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Piemonti', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Vos', 'Affiliation': 'Microbiology, WUR, Wageningen, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Roep', 'Affiliation': 'Department of Immunology, LUMC, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands m.nieuwdorp@amsterdamumc.nl.'}]",Gut,['10.1136/gutjnl-2020-322630']
1553,33106389,Reliability of outcome measures in clinical trials in secondary progressive multiple sclerosis.,"OBJECTIVE


To investigate the reliability of clinical outcomes in secondary progressive multiple sclerosis (SPMS) trials, we compared the frequency of progression and ""improvement"" events on different clinical outcome measures in the placebo arms of 2 large randomized controlled trial (RCT) datasets.
METHODS


Using original trial data from the placebo arms of IMPACT and ASCEND, 2 large RCTs in SPMS, we compared disability progression and similarly defined ""improvement"" with and without 3 or 6 month confirmation on the outcome measures EDSS, timed 25 foot walk (T25FW), nine-hole peg test (9HPT), and their combinations.
RESULTS


In both datasets, the EDSS showed the highest rates of ""improvement"" over time, and the smallest difference between progression and ""improvement"" rates, followed by the T25FW and the 9HPT. For the T25FW and 9HPT, ""improvement"" rates were fairly stable over time and remained at below or around the 10% level. For the EDSS, ""improvement"" rates increased in parallel with disability progression rates.
CONCLUSIONS


All investigated outcome measures in SPMS showed some evidence of random variation and measurement error, the T25FW and 9HPT less so than the more established outcome EDSS. Our findings are relevant for the design and critical appraisal of trials in SPMS.",2020,"For the T25FW and 9HPT, ""improvement"" rates were fairly stable over time and remained at below or around the 10% level.",['secondary progressive multiple sclerosis (SPMS'],['placebo'],"['outcome measures EDSS, timed 25 foot walk (T25FW), nine-hole peg test (9HPT), and their combinations', 'T25FW and 9HPT, ""improvement"" rates']","[{'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}]",,0.109667,"For the T25FW and 9HPT, ""improvement"" rates were fairly stable over time and remained at below or around the 10% level.","[{'ForeName': 'Marcus W', 'Initials': 'MW', 'LastName': 'Koch', 'Affiliation': 'From the Department of Clinical Neurosciences, University of Calgary, Canada mwkoch@ucalgary.ca.'}, {'ForeName': 'Jop', 'Initials': 'J', 'LastName': 'Mostert', 'Affiliation': 'Department of Neurology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Repovic', 'Affiliation': 'Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bowen', 'Affiliation': 'Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Uitdehaag', 'Affiliation': 'Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham.'}]",Neurology,['10.1212/WNL.0000000000011123']
1554,33106414,Longitudinally adaptive assessment and instruction increase numerical skills of preschool children.,"Social inequality in mathematical skill is apparent at kindergarten entry and persists during elementary school. To level the playing field, we trained teachers to assess children's numerical and spatial skills every 10 wk. Each assessment provided teachers with information about a child's growth trajectory on each skill, information designed to help them evaluate their students' progress, reflect on past instruction, and strategize for the next phase of instruction. A key constraint is that teachers have limited time to assess individual students. To maximize the information provided by an assessment, we adapted the difficulty of each assessment based on each child's age and accumulated evidence about the child's skills. Children in classrooms of 24 trained teachers scored 0.29 SD higher on numerical skills at posttest than children in 25 randomly assigned control classrooms ( P  = 0.005). We observed no effect on spatial skills. The intervention also positively influenced children's verbal comprehension skills (0.28 SD higher at posttest,  P  < 0.001), but did not affect their print-literacy skills. We consider the potential contribution of this approach, in combination with similar regimes of assessment and instruction in elementary schools, to the reduction of social inequality in numerical skill and discuss possible explanations for the absence of an effect on spatial skills.",2020,"The intervention also positively influenced children's verbal comprehension skills (0.28 SD higher at posttest,  P  < 0.001), but did not affect their print-literacy skills.",['preschool children'],[],"['numerical skills', 'spatial skills', 'print-literacy skills', ""children's verbal comprehension skills""]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",25.0,0.066581,"The intervention also positively influenced children's verbal comprehension skills (0.28 SD higher at posttest,  P  < 0.001), but did not affect their print-literacy skills.","[{'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Raudenbush', 'Affiliation': 'Department of Sociology, University of Chicago, Chicago, IL 60637; sraudenb@uchicago.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Department of Education and Child Development, National Opinion Research Center, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Goldin-Meadow', 'Affiliation': 'Committee on Education, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carrazza', 'Affiliation': 'Committee on Education, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Foley', 'Affiliation': 'Committee on Education, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Leslie', 'Affiliation': 'UChicago STEM Education, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Sorkin', 'Affiliation': 'Committee on Education, University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Levine', 'Affiliation': 'Committee on Education, University of Chicago, Chicago, IL 60637.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2002883117']
1555,33106446,A comparison of preoperative psychological preparation with midazolam premedication to reduce anxiety in children undergoing adenotonsillectomy.,"Introduction


Considering the multiplicity of adenotonsillectomy in children 2-10-year old at the paediatric surgery centres, patient anxiety leads to an increase in surgical and anaesthetic complications. Patients' unfamiliarity with surgical and anaesthetic interventions may increase their stress. Midazolam premedication reduces patient anxiety. In previous studies, psychological preparation before surgery using understandable terms to children, has reduced their anxiety. The aim of this study was to compare and study behavioural reflections among the children in two groups: the first group was prescribed oral midazolam, and the second group received psychological preparation with the booklet about anaesthesia and anaesthesia-resident explanation.
Materials and Methods


This study is a clinical trial conducted on 48 children undergoing adenotonsillectomy. Children in the first group (midazolam group) received oral midazolam 0.5 mg/kg, 20 min before surgery. A booklet containing pictures and information about anaesthesia and the operating room was given to the second group (psychological preparation group) the night before surgery and anaesthesia resident explained the booklet to the children. The anxiety level was measured in both groups using the State-Trait Anxiety Inventory for Children questionnaire the night before surgery and on the morning of surgery (after giving midazolam to Group II). The results were analysed using SPSS.
Results


In this study, 58.3% of the first group and 45.8% of the second group were male. The mean age of the first and second groups was 8.45 ± 1.86 and 9.12 ± 1.72 years, respectively. The anxiety in the first group significantly decreased in the morning before surgery compared to the night before operation (P < 0.001). The anxiety in the second group significantly decreased in the morning before surgery compared to the night before as well (P < 0.001).
Conclusion


The results showed that midazolam and psychological preparation prior to surgery can reduce the anxiety of children before adenotonsillectomy.",2020,The anxiety in the first group significantly decreased in the morning before surgery compared to the night before operation (P < 0.001).,"['48 children undergoing adenotonsillectomy', 'children undergoing adenotonsillectomy', 'children 2-10-year old at the paediatric surgery centres']","['Midazolam premedication', 'midazolam premedication', 'psychological preparation with the booklet about anaesthesia and anaesthesia-resident explanation', 'oral midazolam', 'midazolam']","['anxiety level', 'anxiety', 'surgical and anaesthetic complications', 'patient anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392008', 'cui_str': 'Complication of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",48.0,0.0213079,The anxiety in the first group significantly decreased in the morning before surgery compared to the night before operation (P < 0.001).,"[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Seyedhejazi', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Behzad Aliakbar', 'Initials': 'BA', 'LastName': 'Sharabiani', 'Affiliation': 'Department of Faculty of Medicine, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Davari', 'Affiliation': 'Department of Faculty of Medicine, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Taghizadieh', 'Affiliation': 'Department of Faculty of Medicine, Tabriz University of Medical Science, Tabriz, Iran.'}]",African journal of paediatric surgery : AJPS,['10.4103/ajps.AJPS_62_17']
1556,33106606,Randomized clinical trial: efficacy and tolerability of two different split dose of low-volume polyethylene glycol electrolytes for bowel preparation before colonoscopy in hospitalized children.,"BACKGROUND


Eighty milliliter per kilogram of polyethylene glycol (PEG) for bowel preparation (BP) has been recommended, but the amount of liquid orally without nasogastric intubation is difficult to achieve. This study is to compare the efficacy and tolerability of two different low-volume PEG electrolyte solutions for BP in children.
METHODS


The randomized, double-blind, controlled trial enrolled 150 children aged 6-18 years undergoing colonoscopy in our center. Patients were randomly assigned to receive 60 ml/kg (PEG-ELS 60) or 40 ml/kg (PEG-ELS 40) of PEG electrolytes (PEG-ELS) 4000. The Boston Bowel Preparation Scale was used for bowel cleansing evaluation. Primary end point was overall colon cleansing. Tolerability was also evaluated.
RESULTS


PEG-ELS 40 and PEG-ELS 60 had similar efficacy in bowel cleansing for both whole colon and various colonic segments. The proportions of patients experiencing any adverse symptoms, or those who were willing to have BP repeated if necessary were similar in both groups. More patients considered the BP solution easy to take and be satisfied with the preparation in PEG-ELS 40 than PEG-ELS 60.
CONCLUSIONS


Low volume of PEG-ELS for BP has good efficacy in bowel cleansing. PEG-ELS with 40 ml/kg volume was not inferior to that of 60 ml/kg.
IMPACT


PEG-ELS 40 and PEG-ELS 60 had similar efficacy in bowel cleansing for whole and various colonic segments. The proportions of patients experiencing any adverse symptoms, or those who were willing to have BP repeated if necessary were similar in both groups. More patients considered BP solution easy to take and be satisfied with the preparation in PEG-ELS 40 than PEG-ELS 60. This study showed that low-volume PEG-ELS monotherapy was effective in bowel cleansing and explored a possibly feasible BP method for pediatrics in China that PEG-ELS 40 was comparable to PEG-ELS 60 regimen.",2020,"RESULTS


PEG-ELS 40 and PEG-ELS 60 had similar efficacy in bowel cleansing for both whole colon and various colonic segments.","['BP in children', 'hospitalized children', '150 children aged 6-18 years undergoing colonoscopy in our center']","['polyethylene glycol (PEG', 'low-volume PEG electrolyte solutions', 'low-volume polyethylene glycol electrolytes', '60\u2009ml/kg (PEG-ELS 60) or 40\u2009ml/kg (PEG-ELS 40) of PEG electrolytes (PEG-ELS']","['Tolerability', 'efficacy and tolerability', 'overall colon cleansing']","[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0115639', 'cui_str': 'EL-40'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}]",150.0,0.102566,"RESULTS


PEG-ELS 40 and PEG-ELS 60 had similar efficacy in bowel cleansing for both whole colon and various colonic segments.","[{'ForeName': 'Shengbo', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'Department of Pharmacy, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacy, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatric Gastroenterology Unit, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric Gastroenterology Unit, The First Hospital of Jilin University, Changchun, Jilin, China. wanglibo75@163.com.'}]",Pediatric research,['10.1038/s41390-020-01216-5']
1557,33106874,OrderRex clinical user testing: a randomized trial of recommender system decision support on simulated cases.,"OBJECTIVE


To assess usability and usefulness of a machine learning-based order recommender system applied to simulated clinical cases.
MATERIALS AND METHODS


43 physicians entered orders for 5 simulated clinical cases using a clinical order entry interface with or without access to a previously developed automated order recommender system. Cases were randomly allocated to the recommender system in a 3:2 ratio. A panel of clinicians scored whether the orders placed were clinically appropriate. Our primary outcome included the difference in clinical appropriateness scores. Secondary outcomes included total number of orders, case time, and survey responses.
RESULTS


Clinical appropriateness scores per order were comparable for cases randomized to the order recommender system (mean difference -0.11 order per score, 95% CI: [-0.41, 0.20]). Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]). Case times were comparable with the recommender system. Order suggestions generated from the recommender system were more likely to match physician needs than standard manual search options. Physicians used recommender suggestions in 98% of available cases. Approximately 95% of participants agreed the system would be useful for their workflows.
DISCUSSION


User testing with a simulated electronic medical record interface can assess the value of machine learning and clinical decision support tools for clinician usability and acceptance before live deployments.
CONCLUSIONS


Clinicians can use and accept machine learned clinical order recommendations integrated into an electronic order entry interface in a simulated setting. The clinical appropriateness of orders entered was comparable even when supported by automated recommendations.",2020,"Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]).",['43 physicians entered orders for 5 simulated clinical cases using a clinical order entry interface with or without access to a previously developed automated order recommender system'],['machine learning-based order recommender system'],"['clinical appropriateness scores', 'total number of orders, case time, and survey responses']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0423634,"Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]).","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Rachael C', 'Initials': 'RC', 'LastName': 'Aikens', 'Affiliation': 'Program in Biomedical Informatics, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hom', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shieh', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of Medicine, Center for Biomedical Informatics Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Saini', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Musen', 'Affiliation': 'Department of Medicine, Center for Biomedical Informatics Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Public Health, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Altman', 'Affiliation': 'Departments of Bioengineering, Genetics, Medicine, and Biomedical Data Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Goldstein', 'Affiliation': 'Geriatrics Research Education and Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Asch', 'Affiliation': 'Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa190']
1558,33106892,Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease.,"BACKGROUND


Pediatric patients with advanced chronic kidney disease (CKD) are often prescribed oral phosphate binders (PBs) for the management of hyperphosphatemia. However, available PBs have limitations, including unfavorable tolerability and safety.
METHODS


This phase 3, multicenter, randomized, open-label study investigated safety and efficacy of sucroferric oxyhydroxide (SFOH) in pediatric and adolescent subjects with CKD and hyperphosphatemia. Subjects were randomized to SFOH or calcium acetate (CaAc) for a 10-week dose titration (stage 1), followed by a 24-week safety extension (stage 2). Primary efficacy endpoint was change in serum phosphorus from baseline to the end of stage 1 in the SFOH group. Safety endpoints included treatment-emergent adverse events (TEAEs).
RESULTS


Eighty-five subjects (2-18 years) were randomized and treated (SFOH, n = 66; CaAc, n = 19). Serum phosphorus reduction from baseline to the end of stage 1 in the overall SFOH group (least squares [LS] mean ± standard error [SE]) was - 0.488 ± 0.186 mg/dL; p = 0.011 (post hoc analysis). Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005). Similar proportions of subjects reported ≥ 1 TEAE in the SFOH (75.8%) and CaAc (73.7%) groups. Withdrawal due to TEAEs was more common with CaAc (31.6%) than with SFOH (18.2%).
CONCLUSIONS


SFOH effectively managed serum phosphorus in pediatric patients with a low pill burden and a safety profile consistent with that reported in adult patients.",2020,Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005).,"['pediatric patients with chronic kidney disease', 'pediatric patients', 'Pediatric patients with advanced chronic kidney disease (CKD', 'pediatric and adolescent subjects with CKD and hyperphosphatemia', 'Eighty-five subjects (2-18\xa0years']","['SFOH or calcium acetate (CaAc', 'sucroferric oxyhydroxide', 'sucroferric oxyhydroxide (SFOH', 'oral phosphate binders (PBs']","['Serum phosphorus reduction', 'Safety and efficacy', 'unfavorable tolerability and safety', 'serum phosphorus', 'treatment-emergent adverse events (TEAEs']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0439703,Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005).,"[{'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Greenbaum', 'Affiliation': ""Division of Pediatric Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, 2015 Uppergate Drive NE, Atlanta, GA, 30322, USA. lgreen6@emory.edu.""}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Jeck', 'Affiliation': 'KfH Pediatric Kidney Center and Department of Pediatrics II, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Klaus', 'Affiliation': 'KfH Pediatric Kidney Center and Department of Pediatrics II, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fila', 'Affiliation': 'CHU Hôpital Arnaud de Villeneuve, Montpellier, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Stoica', 'Affiliation': 'Institutul Clinic Fundeni, Bucharest, Romania.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Fathallah-Shaykh', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Paredes', 'Affiliation': ""Nicklaus Children's Hospital, Miami, FL, USA.""}, {'ForeName': 'Larysa', 'Initials': 'L', 'LastName': 'Wickman', 'Affiliation': ""C.S Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, USA.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Nelson', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Rita D', 'Initials': 'RD', 'LastName': 'Swinford', 'Affiliation': 'The University of Texas Medical School at Houston, Houston, TX, USA.'}, {'ForeName': 'Carolyn Larkins', 'Initials': 'CL', 'LastName': 'Abitbol', 'Affiliation': 'University of Miami - Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Balgradean', 'Affiliation': 'UMF \'Carol Davila\' Spitalul Clinic de Urgenţă pentru copii ""Maria Sklodowska Curie"", Bucharest, Romania.'}, {'ForeName': 'Augustina', 'Initials': 'A', 'LastName': 'Jankauskiene', 'Affiliation': 'Vilnius University hospital Santaros klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Vifor Pharma Management Ltd., Glattbrugg, Switzerland.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Enoiu', 'Affiliation': 'Vifor Pharma Management Ltd., Glattbrugg, Switzerland.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': ""Children's National Hospital, The George Washington University, Washington, DC, USA.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04805-y']
1559,33106952,Group Training for Psychiatric Residents: Support Group Facilitation and Supervision with Didactics.,"OBJECTIVE


Group psychotherapy merits dedicated training during psychiatry residency yet is challenging to implement given competing educational requirements. The authors implemented a voluntary support group training intervention for psychiatry residents consisting of a 6-h didactic series followed by at least 6 months of in vivo group facilitation and supervision. We hypothesized participation would improve residents' self-reported skill and knowledge in group facilitation.
METHODS


Psychiatry residents (PGY I-IV) voluntarily participated in this novel intervention that included a didactic series followed by experiential group facilitation and supervision. To assess confidence and self-reported skill level in group facilitation, residents completed two brief self-report surveys: before the didactic series (pre-intervention) and after group facilitation for at least 6 months (post-intervention). Surveys included Likert scales and open-ended questions. Quantitative data were analyzed with descriptive statistics and open-ended qualitative data were analyzed using thematic analysis.
RESULTS


Twenty-three residents attended 4 to 6 h of didactics between 2016 and 2018. Of these 23 residents, 12 facilitated groups and attended supervision for at least 6 months. Twenty residents responded to pre-intervention surveys and 14 responded to post-intervention surveys. After the intervention, respondents reported a significant increase in knowledge and skills in group facilitation of 88% (15/17) on Likert scale questions.
CONCLUSIONS


This study implemented a novel educational intervention to train psychiatric residents in group dynamics and group facilitation. Participation increased residents' self-reported knowledge and skills in group facilitation. Future directions include incorporating feedback about group curriculum, evaluating resident knowledge and skills using assessment measures, recruiting more group participants, and focusing on peer-to-peer mentoring.",2020,"After the intervention, respondents reported a significant increase in knowledge and skills in group facilitation of 88% (15/17) on Likert scale questions.
","['Twenty-three residents attended 4 to 6 h of didactics between 2016 and 2018', 'Psychiatry residents (PGY I-IV) voluntarily participated in this', '23 residents, 12 facilitated groups and attended supervision for at least 6 months', 'Twenty residents responded to pre-intervention surveys and 14 responded to post-intervention surveys']","['voluntary support group training intervention', 'novel educational intervention', 'novel intervention that included a didactic series followed by experiential group facilitation and supervision']","['Likert scale questions', 'knowledge and skills', 'Likert scales and open-ended questions']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}]",,0.0163304,"After the intervention, respondents reported a significant increase in knowledge and skills in group facilitation of 88% (15/17) on Likert scale questions.
","[{'ForeName': 'Meenakshi S', 'Initials': 'MS', 'LastName': 'Denduluri', 'Affiliation': 'Stanford University, Stanford, CA, USA. mshiv@stanford.edu.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Gold', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Wilmarie Cidre', 'Initials': 'WC', 'LastName': 'Serrano', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spelber', 'Affiliation': 'The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bentzley', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Forte', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sallie G', 'Initials': 'SG', 'LastName': 'De Golia', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}]",Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry,['10.1007/s40596-020-01338-2']
1560,33106968,"Impact of early intervention with onabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: results from the double-blind, placebo-controlled, phase 3 REFLEX study.","The aim of this study in patients with post-stroke lower limb spasticity (PSLLS) was to evaluate the relationship between time of onabotulinumtoxinA treatment relative to stroke and efficacy outcomes. This was a phase 3, international, multicenter, randomized, 12-week, double-blind study, followed by a repeated treatment, open-label extension. Patients were aged 18-85 years with PSLLS (Modified Ashworth Scale [MAS] ≥ 3) of the ankle with the most recent stroke occurring ≥ 3 months before screening. Patients (double-blind phase) were randomized (n = 468) to onabotulinumtoxinA 300-400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and ≤ 100 U, optional lower limb muscles (flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, and rectus femoris]) or placebo. Primary endpoint: MAS change from baseline (average score of weeks 4 and 6). Secondary endpoints: physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12). When stratified by time since stroke (≤ 24 months, n = 153; > 24 months, n = 315, post hoc), patients treated ≤ 24 months post-stroke experienced greater improvements from baseline versus placebo in MAS (- 0.31 vs - 0.17), CGI (0.49 vs 0.12), and passive GAS scores (week 12, 0.37 vs 0.26). A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04). OnabotulinumtoxinA 300-400 U was well tolerated, with no new safety findings.",2020,"A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04).","['Patients were aged 18-85\xa0years with PSLLS (Modified Ashworth Scale [MAS]\u2009≥\u20093) of the ankle with the most recent stroke occurring\u2009≥\u20093\xa0months before screening', 'adult patients with post-stroke lower limb spasticity', 'patients with post-stroke lower limb spasticity (PSLLS']","['onabotulinumtoxinA 300-400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and\u2009≤\u2009100 U, optional lower limb muscles', 'placebo', 'onabotulinumtoxinA treatment', 'OnabotulinumtoxinA']","['physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12', 'MAS change from baseline (average score of weeks 4 and 6', 'active scores', 'GAS scores', 'passive GAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0224463', 'cui_str': 'Tibialis posterior muscle structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.394937,"A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04).","[{'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone and Joint Clinic, Overland Park, KS, USA. apatel@kcbj.com.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Ward', 'Affiliation': 'Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Staffordshire University, Stoke on Trent, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Geis', 'Affiliation': 'Brooks Rehabilitation/Physician Group, Halifax Health, Daytona Beach, FL, USA.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Jost', 'Affiliation': 'Department of Neurology, University of Freiburg, Freiburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Allergan Plc, Madison, NJ, USA.'}, {'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Dimitrova', 'Affiliation': 'Allergan Plc, Irvine, CA, USA.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02251-6']
1561,33107163,Sleep differentially impacts involuntary intrusions and voluntary recognitions of lab-analogue traumatic memories.,"Despite the critical role of sleep in memory and emotion processing, large remains unknown regarding how sleep influences trauma-related symptoms arising from maladaptive memory/emotional processes, such as those among patients with post-traumatic stress disorder. Employing a trauma film paradigm, we investigated how post-trauma sleep versus sleep deprivation influenced involuntary intrusions and voluntary recognition of traumatic memories. Sixty participants were randomly assigned to sleep or total sleep deprivation group following experimental trauma induction. Participants were assessed with: (a) lab-based and 7-day diary-based involuntary intrusions; (b) voluntary recognitions of traumatic memories 12-hr and 7-day post-trauma induction; and (c) post-traumatic stress disorder-like symptoms measured by the Impact of Event Scale-Revised. We found that compared with sleep deprivation, slept participants experienced fewer traumatic intrusions across 7 days, reported lower emotional hyperarousal, and showed more accurate recognition of trauma-related stimuli. Moreover, higher subjective sleep quality was associated with fewer intrusions only in the sleep group, while a reversed pattern emerged in the sleep deprivation group. These results provide novel evidence supporting the therapeutic benefits of sleep in protecting mental well-being from trauma exposure. To the extent that sleep modulates trauma-related symptoms, sleep can be conceived as the potential target for early interventions among trauma victims.",2020,"We found that compared with sleep deprivation, slept participants experienced fewer traumatic intrusions across 7 days, reported lower emotional hyperarousal, and showed more accurate recognition of trauma-related stimuli.","['patients with post-traumatic stress disorder', 'Sixty participants']",['sleep or total sleep deprivation group following experimental trauma induction'],"['traumatic intrusions', 'subjective sleep quality', 'lower emotional hyperarousal', 'Sleep differentially impacts involuntary intrusions and voluntary recognitions of lab-analogue traumatic memories', 'involuntary intrusions and voluntary recognition of traumatic memories', 'accurate recognition of trauma-related stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",60.0,0.0517962,"We found that compared with sleep deprivation, slept participants experienced fewer traumatic intrusions across 7 days, reported lower emotional hyperarousal, and showed more accurate recognition of trauma-related stimuli.","[{'ForeName': 'Shengzi', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Esther Yuet Ying', 'Initials': 'EYY', 'LastName': 'Lau', 'Affiliation': 'Sleep Laboratory, Department of Psychology, The Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shirley Xin', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}]",Journal of sleep research,['10.1111/jsr.13208']
1562,33107209,The effect of cardiac rehabilitation program on functional capacity and waist to hip ratio in patients with coronary artery disease: A clinical trial.,"AIMS


This study aimed to determine the impact of cardiac rehabilitation programs on functional capacity and waist to hip ratio in coronary artery disease (CAD) patients.
METHODS


In this clinical trial study 70 CAD patients were selected using purposive sampling and based on inclusion criteria. The intervention consisted of a 12-week training and exercise program included walking sessions at home at least three times a week. The 6-min walk test (6MWT) was conducted to measure the functional capacity and waist to hip ratio (WHR), as the anthropometric index, in both groups before and after the intervention. Data were analyzed in SPSS 21 using independent t test, paired t test, and Chi-square test.
RESULTS


The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention. After the intervention, this distance was 509.03 and 389.91 m in intervention and control groups respectively, suggesting a significant difference between the two groups (p < .001). The mean WHR was 0.8648 and 0.8403 in intervention and in control respectively before the intervention. After the intervention, this value became 0.7985 and 0.8555 in intervention and control groups respectively and showed significant difference (p < .001).
CONCLUSIONS


The cardiac rehabilitation program improved the ability of patients in the 6MWT and enhanced their functional capacity and reduced the mean WHR, which in turn evinces the improvement of the anthropometric index and mitigation of risk factors in CAD patients. So, healthcare providers can deploy such rehabilitation programs to empower patients, alleviate disease complications, and reduce individual and social costs of cardiovascular diseases.",2020,The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention.,"['70 CAD patients were selected using purposive sampling and based on inclusion criteria', 'coronary artery disease (CAD) patients', 'patients with coronary artery disease']","['12-week training and exercise program included walking sessions', 'cardiac rehabilitation program', 'cardiac rehabilitation programs']","['mean WHR', 'mean distance traveled', 'functional capacity and waist to hip ratio (WHR', '6-min walk test (6MWT', 'anthropometric index and mitigation of risk factors', 'functional capacity and waist to hip ratio']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",70.0,0.0260125,The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Sahabazi Deh Sokhteh', 'Affiliation': 'Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pishkar', 'Affiliation': 'Faculty member of Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rafizadeh', 'Affiliation': 'Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Yaghoubinia', 'Affiliation': 'Community Nursing Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12386']
1563,33107252,[Clinical study of movable external fixation for elbow tuberculosis].,"OBJECTIVE


To compare clinical effect of movable external fixation and fusion fixation for the treatment of elbow tuberculosis.
METHODS


From October 2013 to June 2019, 52 patients with elbow tuberculosis treated with standard antituberculosis therapy were divided into movable external fixation group and fusion fixation group according to treatment methods. In group A, there were 25 patients, including 11 males and 14 females, aged from 24 to 75 years old with an average of (42.81± 9.01) years old; the courses of diseases ranged from 2 to 9 months with an average of (3.96±1.45) months. In group B, there were 27 patients, including 15 males and 12 females, aged from 23 to 77 years old with an averageof (44.08±7.44) years old; the courses of diseases ranged from 2 to 7 months with an average of (3.88±1.67) months. All patients were performed focus debridement. Intraoperative blood loss, operative time were compared between two groups. VAS score before operation, 2 weeks and 12 months after operation were applied to evaluate pain relieve;Mayo elbow performance score (MEPS) before operation, 1 and 12 months after operation were used to evaluate clinical effect;changes of erythrocyte sedimentation rate (ESR) and Creactive protein, CRP) before operation, 3 weeks after antituberculosis therapy, 1 week and 6 months after operation were compared between two groups.
RESULTS


All patients were followed up from 12 to 20 months with an average of (13.50±4.85) months. No mixed infection and recurrence of tuberculosis occurred. There were no statistical differences in intraoperative blood loss and operative time( P >0.05). There was difference in postoperative VAS score at 2 weeks between movable external fixation group (5.15±0.95) and fusion fixation group (4.04±0.84)( P <0.01);while no difference in postoperative VAS score at 12 months between two groups ( P >0.05). No difference in ESR and CRP level between two groups before and after operation ( P >0.05). Postoperative Mayo score at 1 and 12 months in movable external fixation group were (78.15±7.83) and (90.19±7.13);in fusion fixation group were (70.40±7.61) and (82.60±8.38);there were differences in Mayo score at different time points between two groups( P <0.01).
CONCLUSION


For elbow tuberculosis, movable external fixation and fusion fixation have equal effect in operative time, amount of bleeding and control of tuberculosis infection indicator. Movable external fixation need earlier functional exercise, not conducive to pain relief at early stage, which may be better than fusion fixation, it is worth clinical promoting.",2020,There were no statistical differences in intraoperative blood loss and operative time( P >0.05).,"['25 patients, including 11 males and 14 females, aged from 24 to 75 years old with an average of (42.81± 9.01) years old; the courses of diseases ranged from 2 to 9 months with an average of (3.96±1.45) months', 'From October 2013 to June 2019, 52 patients with elbow tuberculosis treated with standard antituberculosis therapy', 'elbow tuberculosis', '27 patients, including 15 males and 12 females, aged from 23 to 77 years old with an averageof (44.08±7.44) years old; the courses of diseases ranged from 2 to 7 months with an average of (3.88±1.67) months']","['Movable external fixation need earlier functional exercise', 'movable external fixation and fusion fixation', 'movable external fixation group and fusion fixation group according to treatment methods', 'movable external fixation']","['intraoperative blood loss and operative time', 'ESR and CRP level', 'Intraoperative blood loss, operative time', 'pain relieve;Mayo elbow performance score (MEPS', 'VAS score', 'Mayo score', 'operative time, amount of bleeding and control of tuberculosis infection indicator', 'erythrocyte sedimentation rate (ESR) and Creactive protein, CRP', 'Postoperative Mayo score', 'postoperative VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003448', 'cui_str': 'Antituberculosis agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",52.0,0.0133836,There were no statistical differences in intraoperative blood loss and operative time( P >0.05).,"[{'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zu', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fei', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}, {'ForeName': 'Da-Wei', 'Initials': 'DW', 'LastName': 'Bi', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}, {'ForeName': 'Chen-Wei', 'Initials': 'CW', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Borens', 'Affiliation': 'Department of Orthopaedics, Tuberculosis Diagnosis and Treatment Center, Zhejiang Integrated Traditional Chinese and Western Medicine Hospital, Hangzhou 310003, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.10.005']
1564,33107278,Effects of vitamin D prophylaxis on oral iron treatments of iron deficiency anemia.,"BACKGROUND


Iron deficiency anemia causes a decrease in immune response to infections, physical working capacity and response to metabolic stress. It also causes behavioral, perceptual and cognitive disorders. Therefore, as soon as iron deficiency anemia is diagnosed, it should be treated immediately. In this study, it was investigated retrospectively whether there was a difference in treatment efficacy between the administration of oral ferrous or ferric iron and vitamin D at the same time and at different time.
METHODS


A total of sixty patients under 1 year who attended the pediatrics outpatient clinic for pale and diagnosed with iron deficiency anemia. Patients were randomly divided into 4 groups. Anemia was defined as hemoglobin below <2 SD according to age and gender. Iron deficiency was definied with serum iron, iron-binding capacity, ferritin and transferin saturation below the range for age and gender appropriates. All patients were seen at the outpatient clinic for 1st, 3rd month of the treatment.
RESULTS


There were a statistically significant differences between the groups in terms of increase in Hb values according to time (1st month, 3rd month, 1st and 3rd month). There was no statistically significant difference between the groups in terms of the recovery of anemia after treatment.
CONCLUSIONS


It was concluded that iron treatment in babies with iron deficiency anemia is not affected by the administration of vitamin D prophylaxis at the same time or at different times, and therefore both treatments can be administered at the same time to increase drug compliance.",2020,"There were a statistically significant differences between the groups in terms of increase in Hb values according to time (1st month, 3rd month, 1st and 3rd month).","['sixty patients under 1 year who attended the pediatrics outpatient clinic for pale and diagnosed with iron deficiency anemia', 'iron deficiency anemia', 'babies with iron deficiency anemia']","['oral ferrous or ferric iron and vitamin D', 'vitamin D prophylaxis']","['serum iron, iron-binding capacity, ferritin and transferin saturation', 'Hb values', 'recovery of anemia', 'Anemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030232', 'cui_str': 'Pale complexion'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0373658', 'cui_str': 'Iron binding capacity'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",60.0,0.0431779,"There were a statistically significant differences between the groups in terms of increase in Hb values according to time (1st month, 3rd month, 1st and 3rd month).","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kan', 'Affiliation': 'Department of Pediatrics, Dicle University Faculty of Medicine, Diyarbakır, Turkey - rodmerrod1980@gmail.com.'}, {'ForeName': 'Tulin R', 'Initials': 'TR', 'LastName': 'Sayli', 'Affiliation': 'Department of Child Health and Disease Ministry of Health Ankara City Hospital, Ankara, Turkey.'}]",Minerva pediatrica,['10.23736/S0026-4946.20.06073-9']
1565,33107329,Effects of listening to binaural beats on anxiety levels and pain scores in male patients undergoing cystoscopy and ureteral stent removal: A randomized placebo-controlled trial.,"PURPOSE


To investigate the effects of pure binaural beats on anxiety and pain scores in male patients undergoing diagnostic cystoscopy (DC) and ureteral stent removal (USR) under local anesthesia.
MATERIALS AND METHODS


This was a prospective randomized, placebo-controlled study. Patients in the DC group (DCG) and USR group (USRG) were divided into three subgroups according to interventions applied; DCG-1 and USRG-1, patients listened to binaural beats; DCG-2 and USRG-2, patients listened to classical music; DCG-3 and USRG-3, patients no audio only headphones (control group). State-Trait Anxiety Inventory (STAI) and Visual Analog Scale (VAS) are used for measuring anxiety and pain scores, respectively. Demographic data, initial STAI (STAI-I), tolerance rate of interventions, terminal STAI (STAI-T), differences of STAI ( delta STAI: STAI-D) and VAS scores were compared.
RESULTS


Between July 2019 and March 2020, a total of 252 and 159 eligible male patients for DCG and USRG were included, respectively. After exclusions, remaining patients were; DCG-1, n = 61; DCG-2, n = 73; DCG-3, n = 75; USRG-1, n = 41; USRG-2, n = 50; and USRG-3, n = 52. The tolerance rate in binaural beats groups was significantly lower than in other groups (p<0.05 for all). There were significant decreases in terms of STAI-T when DCG-1 and DCG-2 compared with DCG-3 and, USRG-1 and USRG-2 compared with USRG-3 (p<0.05 for all). There were significant decreases in STAI-D scores when DCG-1 and DCG-2 compared with DCG-3 and when USRG-1 and USRG-2 compared with USRG-3 (p< 0.001 for all). Binaural beats groups had significantly lower VAS scores than other groups and classical music groups had significantly lower VAS scores than control groups (p<0.05 for all) Conclusions: Listening to pure binaural beats may be a simple and effective method to reduce anxiety levels and pain scores associated with the DC and USR procedures in males.",2020,The tolerance rate in binaural beats groups was significantly lower than in other groups (p<0.05 for all).,"['Patients in the DC group (DCG) and USR group (USRG', 'Between July 2019 and March 2020, a total of 252 and 159 eligible male patients for DCG and USRG were included, respectively', 'male patients undergoing diagnostic cystoscopy (DC) and ureteral stent removal (USR) under local anesthesia', 'male patients undergoing cystoscopy and ureteral stent removal']","['listening to binaural beats', 'placebo', 'DCG-1 and USRG-1, patients listened to binaural beats', 'pure binaural beats']","['VAS scores', 'tolerance rate', 'Demographic data, initial STAI (STAI-I), tolerance rate of interventions, terminal STAI (STAI-T), differences of STAI ( delta STAI: STAI-D) and VAS scores', 'anxiety and pain scores', 'STAI-T', 'anxiety levels and pain scores', 'State-Trait Anxiety Inventory (STAI) and Visual Analog Scale (VAS', 'STAI-D scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401483', 'cui_str': 'Diagnostic cystoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1278795', 'cui_str': 'Removal of ureteral stent'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877369', 'cui_str': 'Terminal state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0462665,The tolerance rate in binaural beats groups was significantly lower than in other groups (p<0.05 for all).,"[{'ForeName': 'Mahmut Taha', 'Initials': 'MT', 'LastName': 'Ölçücü', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Varlık Mah., ANTALYA, Antalya, Turkey, 07100; matah_ol@hotmail.com.'}, {'ForeName': 'Kayhan', 'Initials': 'K', 'LastName': 'Yılmaz', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; kyhn_79@hotmail.com.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Karamık', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; kaankaramik@gmail.com.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Okuducu', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; yahyaokuducu@yahoo.com.tr.'}, {'ForeName': 'Çağatay', 'Initials': 'Ç', 'LastName': 'Özsoy', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; cagatayozsoy89@gmail.com.'}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Aktaş', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; aktas.yasin.007@hotmail.com.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Çakır', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey; srdr554@hotmail.com.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Ates', 'Affiliation': 'Antalya Training and Research Hospital, 218503, Urology, Antalya, Turkey.'}]",Journal of endourology,['10.1089/end.2020.0353']
1566,33107418,Differential sensitivity to the acute psychotomimetic effects of delta-9-tetrahydrocannabinol associated with its differential acute effects on glial function and cortisol.,"BACKGROUND


Cannabis use has been associated with psychosis through exposure to delta-9-tetrahydrocannabinol (Δ9-THC), its key psychoactive ingredient. Although preclinical and human evidence suggests that Δ9-THC acutely modulates glial function and hypothalamic-pituitary-adrenal (HPA) axis activity, whether differential sensitivity to the acute psychotomimetic effects of Δ9-THC is associated with differential effects of Δ9-THC on glial function and HPA-axis response has never been tested.
METHODS


A double-blind, randomized, placebo-controlled, crossover study investigated whether sensitivity to the psychotomimetic effects of Δ9-THC moderates the acute effects of a single Δ9-THC dose (1.19 mg/2 ml) on myo-inositol levels, a surrogate marker of glia, in the Anterior Cingulate Cortex (ACC), and circadian cortisol levels, the key neuroendocrine marker of the HPA-axis, in a set of 16 healthy participants (seven males) with modest previous cannabis exposure.
RESULTS


The Δ9-THC-induced change in ACC myo-inositol levels differed significantly between those sensitive to (Δ9-THC minus placebo; M = -0.251, s.d. = 1.242) and those not sensitive (M = 1.615, s.d. = 1.753) to the psychotomimetic effects of the drug (t(14) = 2.459, p = 0.028). Further, the Δ9-THC-induced change in cortisol levels over the study period (baseline minus 2.5 h post-drug injection) differed significantly between those sensitive to (Δ9-THC minus placebo; M = -275.4, s.d. = 207.519) and those not sensitive (M = 74.2, s.d. = 209.281) to the psychotomimetic effects of the drug (t(13) = 3.068, p = 0.009). Specifically, Δ9-THC exposure lowered ACC myo-inositol levels and disrupted the physiological diurnal cortisol decrease only in those subjects developing transient psychosis-like symptoms.
CONCLUSIONS


The interindividual differences in transient psychosis-like effects of Δ9-THC are the result of its differential impact on glial function and stress response.",2020,"Specifically, Δ9-THC exposure lowered ACC myo-inositol levels and disrupted the physiological diurnal cortisol decrease only in those subjects developing transient psychosis-like symptoms.
",['16 healthy participants (seven males) with modest previous cannabis exposure'],"['placebo', 'delta-9-tetrahydrocannabinol', 'Δ9-THC']","['glial function and stress response', 'glial function and hypothalamic-pituitary-adrenal (HPA) axis activity', 'physiological diurnal cortisol', 'glial function and cortisol', 'cortisol levels', 'myo-inositol levels, a surrogate marker of glia, in the Anterior Cingulate Cortex (ACC), and circadian cortisol levels, the key neuroendocrine marker of the HPA-axis', 'ACC myo-inositol levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",16.0,0.114733,"Specifically, Δ9-THC exposure lowered ACC myo-inositol levels and disrupted the physiological diurnal cortisol decrease only in those subjects developing transient psychosis-like symptoms.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colizzi', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre, South London and Maudsley NHS Foundation Trust, and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Weltens', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism and Ageing, University of Leuven, Belgium.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Steve Cr', 'Initials': 'SC', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism and Ageing, University of Leuven, Belgium.'}, {'ForeName': 'Sagnik', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre, South London and Maudsley NHS Foundation Trust, and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}]",Psychological medicine,['10.1017/S0033291720003827']
1567,33107439,Randomised trial of block and replace vs dose titration thionamide in young people with thyrotoxicosis.,"Objective


First-line treatment of thyrotoxicosis in young people is thionamide anti-thyroid drug (ATD) in a blocking dose with levothyroxine replacement (block and replace, BR) or in a smaller dose tailored to render the patient euthyroid (dose titration, DT). Our objective was to determine which regimen provides more stable biochemical control.
Design


A multi-centre phase III, open-label randomised trial comparing BR with DT in patients aged 2-17 years with newly diagnosed thyrotoxicosis at 15 UK centres.
Methods


Patients were randomised shortly after diagnosis and treated for 3 years. The primary outcome was the percentage of serum thyroid-stimulating hormone (TSH) levels in the reference range between 6 months and 3 years. Secondary outcomes included the proportion of Free thyroxine (FT4) levels in the reference range, adverse event frequency and 4 years outcome (remission/relapse).
Results


Eighty-two patients were randomised, with details on clinical course in 81 (62 Female); 40 were allocated to BR (41 DT). Three withdrew with one ineligible. The mean percentage of serum TSH within reference range was 60.2% in BR and 63.8% in DT patients; adjusted difference 4.3%, 95% CI (-7.8 to 16.4); P = 0.48. Proportions for FT4 were 79.2% in BR and 85.7% in DT patients; adjusted difference 6.8%, (-0.2 to 15.6); P = 0.13. Three patients developed neutropenia - all on BR. 6 BR and 10 DT patients were in remission at 4y.
Conclusion


This randomised trial has shown no evidence to suggest that BR, when managing the young patient with thyrotoxicosis, is associated with improved biochemical stability when compared to DT.",2020,"The mean percentage of serum TSH within reference range was 60.2% in BR and 63.8% in DT patients; adjusted difference 4.3%, 95% CI (-7.8 to 16.4); P = 0.48.","['young people', 'Eighty-two patients were randomised, with details on clinical course in 81 (62 Female); 40 were allocated to BR (41 DT', 'young patient with thyrotoxicosis', 'patients aged 2-17 years with newly diagnosed thyrotoxicosis at 15 UK centres', 'young people with thyrotoxicosis']","['block and replace vs dose titration thionamide', 'levothyroxine replacement (block and replace, BR']","['mean percentage of serum TSH', 'neutropenia ', 'biochemical stability', 'percentage of serum thyroid-stimulating hormone (TSH) levels', 'proportion of Free thyroxine (FT4) levels in the reference range, adverse event frequency and 4 years outcome (remission/relapse']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040156', 'cui_str': 'Thyrotoxicosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",82.0,0.227542,"The mean percentage of serum TSH within reference range was 60.2% in BR and 63.8% in DT patients; adjusted difference 4.3%, 95% CI (-7.8 to 16.4); P = 0.48.","[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Wood', 'Affiliation': 'Department of Paediatric Endocrinology, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cole', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Newcastle upon Tyne, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Donaldson', 'Affiliation': 'Department of Child Health, University of Glasgow School of Medicine, Glasgow, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Statistics & Physics, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Morrison', 'Affiliation': 'Department of Paediatric Endocrinology, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'John N S', 'Initials': 'JNS', 'LastName': 'Matthews', 'Affiliation': 'School of Mathematics, Statistics & Physics, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Simon H S', 'Initials': 'SHS', 'LastName': 'Pearce', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, International Centre for Life, Central Parkway, Newcastle upon Tyne, UK.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Cheetham', 'Affiliation': 'Department of Paediatric Endocrinology, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK.'}]",European journal of endocrinology,['10.1530/EJE-20-0617']
1568,33107455,Effects of chitosan oligosaccharide and calcium hypochlorite on  E. Faecali  dentinal biofilm and smear layer removal - SEM analysis.,"Background


The complex structure and irregularities of root canal walls are liable for infection by several bacterial species. Thus, the use of irrigants and auxiliary chemical solutions associated with instrumentation is necessary for effective eradication of the biofilm as well as complete removal of the smear layer.
Aim


To evaluate the effects of calcium hypochlorite and chitosan oligosaccharide (COS) in disinfecting Enterococcus faecalis root canal biofilm and smear layer removal with minimal erosion.
Materials And Methods


A total of 70 mandibular premolars were decoronated at the cementoenamel junction. The samples were biomechanically prepared, sterilized in an autoclave, and incubated with E. faecalis (ATCC-29212) bacteria for 21 days. Cleaning and shaping were done till maximum apical file size of #45 K. Specimens were randomly divided into 4 groups: GROUP I: Control Group, GROUP II: 5% Sodium Hypochlorite (NaOCl) solution followed by 17% EDTA solution, GROUP III: 5% Calcium Hypochlorite [Ca(OCl) 2 ] solution followed by 17% EDTA solution and GROUP IV: 5% Ca(OCl) 2  solution followed by 1% COS. The samples were subjected to microbial count followed by smear layer removal under scanning electron microscope (SEM) at coronal, middle and apical third.
Statistical Analysis Used


Kruskal-Wallis Test and post-hoc Scheffe's test.
Results


It was observed that Group IV showed the lowest amount of CFU count/mL and the highest amount of smear layer removal with a statistically significant difference (P < 0.05) when compared with the other three Groups.
Conclusion


5% Ca(OCl) 2  solution with 1% COS solution effectively removed the Enterococcus faecalis biofilm and smear layer from the root canals with minimal erosion.",2020,"It was observed that Group IV showed the lowest amount of CFU count/mL and the highest amount of smear layer removal with a statistically significant difference (P < 0.05) when compared with the other three Groups.
",[],"['GROUP', 'GROUP II: 5% Sodium Hypochlorite (NaOCl) solution followed by 17% EDTA solution, GROUP III: 5% Calcium Hypochlorite [Ca(OCl) 2 ] solution followed by 17% EDTA solution and GROUP IV: 5% Ca(OCl) 2  solution followed by 1% COS', 'chitosan oligosaccharide and calcium hypochlorite', 'calcium hypochlorite and chitosan oligosaccharide (COS']",['Enterococcus faecalis biofilm and smear layer'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0054471', 'cui_str': 'Chlorinated lime'}, {'cui': 'C3255751', 'cui_str': 'CHITOSAN OLIGOSACCHARIDE'}]","[{'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}]",70.0,0.017509,"It was observed that Group IV showed the lowest amount of CFU count/mL and the highest amount of smear layer removal with a statistically significant difference (P < 0.05) when compared with the other three Groups.
","[{'ForeName': 'Gurveen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, SRM Kattankulathur Dental College and Hospital, SRM Institute of Science and Technology, Chennai, Tamil Nadu, India.'}, {'ForeName': 'T Vinay', 'Initials': 'TV', 'LastName': 'Kumar Reddy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, SRM Kattankulathur Dental College and Hospital, SRM Institute of Science and Technology, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Kondas Vijay', 'Initials': 'KV', 'LastName': 'Venkatesh', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, SRM Kattankulathur Dental College and Hospital, SRM Institute of Science and Technology, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Mahalakshmi', 'Affiliation': 'Department of Microbiology, Sree Balaji Dental College and Hospital, BIHER, Bharath University, Chennai, Tamil Nadu, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_334_20']
1569,33107460,Comparison of the efficacy of different Ni-Ti instruments in the removal of gutta-percha and sealer in root canal retreatment.,"Aims


To evaluate and compare the efficacy of four rotary instrumentation systems in root canal retreatment and to determine retreatment time.
Materials and Methods


To achieve the purpose of this study, canals of 60 distal roots in mandibular molar teeth were selected and randomly divided into four groups A, B, C and D (n = 15). Using step-back technique, the canals were prepared and filled with gutta-percha and AH Plus employing cold lateral compaction technique. The root filling material was removed with the following retreatment systems: Group A: Mtwo R, group B: D-RaCe, group C: ProTaper R and group D: R-Endo. In order to record retreatment time, a stopwatch was used. The samples were split longitudinally, examined under a stereomicroscope, photographed and assessed with AutoCAD software. Finally, the percentages of remaining filling material were calculated and the extracted data were analyzed using one-way ANOVA and Tukey HSD test.
Results


All examined groups showed traces of remaining filling material within the canals. No statistically significant difference was found among the four groups in the coronal, middle, and apical thirds. The same result was obtained with regard to retreatment time (P > 0.05). However, within each one of the groups, significant difference was observed in the three regions (P < 0.05).
Conclusions


Based on the findings of this study, none of the examined systems could completely remove root filling material from the root canals. However, they were all found to be effective in this regard. The most amount of remaining filling material was found in the apical third.",2020,"No statistically significant difference was found among the four groups in the coronal, middle, and apical thirds.",['60 distal roots in mandibular molar teeth'],"['Ni-Ti instruments', 'gutta-percha and AH Plus employing cold lateral compaction technique']",['percentages of remaining filling material'],"[{'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0076736', 'cui_str': 'Nickel titanium'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.017168,"No statistically significant difference was found among the four groups in the coronal, middle, and apical thirds.","[{'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Nasiri', 'Affiliation': 'Department of Endodontics, Center for Operative Dentistry and Periodontology, University of Dental Medicine and Oral Health, Danube Private University (DPU), Krems, Austria.'}, {'ForeName': 'Karl-Thomas', 'Initials': 'KT', 'LastName': 'Wrbas', 'Affiliation': 'Department of Endodontics, Center for Operative Dentistry and Periodontology, University of Dental Medicine and Oral Health, Danube Private University (DPU), Krems, Austria; Department of Operative Dentistry and Periodontology, Center for Dental Medicine, Oral and Maxillofacial Surgery, Medical Center, University of Freiburg, Freiburg i.Br., Germany.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_946_18']
1570,33107490,Effect of zinc supplementation on relative expression of immune response genes in neonates with sepsis: A preliminary study.,"Background & objectives


Zinc alters gene expression mainly by binding to a site on the transcription factor. Genome-wide expression studies have shown early repression of genes related to zinc and immunity in adult patients with sepsis. The present study was conducted to evaluate the role of zinc supplementation on relative expression of immune response genes in neonatal sepsis.
Methods


In the present study, a sample of convenience of 22 neonates each was selected from the zinc supplemented and control groups using random numbers for expression of immune-related genes by zinc supplementation. These neonates with sepsis were earlier randomized into two groups: with and without zinc supplementation in addition to standard antibiotics and supportive care. Relative expression of immune response genes were analyzed for 22 neonates in each group using quantitative real-time PCR for calprotectin (S100A8/A9), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), toll-like receptor-4 (TLR-4), cluster of differentiation 14 (CD14) and lipopolysaccharide-binding protein (LBP) genes.
Results


An increase in serum zinc levels was observed in zinc-supplemented group compared to controls. S100A8 gene showed downregulation by three-fold (P <0.001) and S100A9 gene showed upregulation by two-fold (P <0.05) in zinc group compared to controls. CD14 gene showed upregulation by one-fold in zinc-supplemented group compared to controls (P <0.05). No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
Interpretation & conclusions


The results of our preliminary study showed that the zinc supplementation might modulates the relative expression of immune-related genes involved in sepsis pathway among neonates. However, studies with larger sample size are needed to be done to provide a better picture on the outcome by gene expression in neonatal sepsis by zinc supplementation.",2020,"No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
","['neonates with sepsis', 'adult patients with sepsis', 'neonatal sepsis', 'sample of convenience of 22 neonates each was selected from the zinc supplemented and control groups using random numbers for expression of immune-related genes by zinc supplementation']","['zinc supplementation in addition to standard antibiotics and supportive care', 'zinc supplementation']","['serum zinc levels', 'TNF-α, IL-6, LBP and TLR-4 genes', 'quantitative real-time PCR for calprotectin (S100A8/A9), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), toll-like receptor-4 (TLR-4), cluster of differentiation 14 (CD14) and lipopolysaccharide-binding protein (LBP) genes', 'relative expression of immune response genes']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0086344', 'cui_str': 'Immune response gene'}]",22.0,0.138615,"No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
","[{'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Banupriya', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Ballambattu Vishnu', 'Initials': 'BV', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Vinayagam', 'Initials': 'V', 'LastName': 'Vickneshwaran', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Magadi Gopalakrishna', 'Initials': 'MG', 'LastName': 'Sridhar', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_557_18']
1571,33107494,Insights from pre-treatment attrition & dropouts in an effectiveness trial of methylphenidate in children.,,2020,,['children'],['methylphenidate'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]",[],,0.034385,,"[{'ForeName': 'Ruchita', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Susanta', 'Initials': 'S', 'LastName': 'Padhy', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Samita', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_1498_18']
1572,33107596,"Clinical, radiographic and patient-centered outcomes after use of enamel matrix proteins for the treatment of intrabony defects in patients with aggressive periodontitis: A 12-month multicenter clinical trial.","BACKGROUND


The aim of this study was to evaluate the clinical, radiographic and patient-centered results of enamel matrix derivative (EMD) therapy in intrabony defects in aggressive periodontitis (AgP) patients and compare them with those in chronic periodontitis (CP) patients.
METHODS


Sixty intrabony defects in AgP and CP patients associated with ≥ 6 mm residual probing pocket depth (PPD) were included and randomly assigned to one of three groups: AgP+CS (conservative surgery) (n = 20); AgP+CS/EMD (n = 20); CP+CS/EMD (n  =  20). Clinical parameters were measured at baseline and after 6 and 12 months. Defect resolution (DR) and bone filling (BF) were used for radiographic analysis. The quality of life was recorded at baseline and 6 months using OHIP-14 and VAS scale in the early post-therapy period.
RESULTS


PPD and relative clinical attachment level (rCAL) improved for all groups during follow-up (p ≤ 0.05), and AgP+CS/EMD presented a higher rCAL gain (2.4 ± 1.0 mm) when compared to AgP control patients (1.6 ± 1.6 mm, p ≤ 0.05) after 12 months. No difference was observed between AgP+CS/EMD and CP+CS/EMD groups (p > 0.05). No radiographic differences were observed among groups at any time point (p > 0.05). All the groups reported a positive impact on OHIP-14 total score, without differences among them.
CONCLUSIONS


EMD therapy of intrabony defects promotes additional benefits in AgP patients, presenting a similar regeneration rate compared to CP patients, and has proven to be a viable therapy for the treatment of individuals with AgP. This article is protected by copyright. All rights reserved.",2020,"RESULTS


PPD and relative clinical attachment level (rCAL) improved for all groups during follow-up (p ≤ 0.05), and AgP+CS/EMD presented a higher rCAL gain (2.4 ± 1.0 mm) when compared to AgP control patients (1.6 ± 1.6 mm, p ≤ 0.05) after 12 months.","['Sixty intrabony defects in AgP and CP patients associated with ≥ 6 mm residual probing pocket depth (PPD', 'aggressive periodontitis (AgP) patients and compare them with those in chronic periodontitis (CP) patients', 'patients with aggressive periodontitis']","['enamel matrix proteins', 'AgP+CS (conservative surgery', 'enamel matrix derivative (EMD) therapy', 'AgP+CS/EMD (n = 20); CP+CS/EMD']","['OHIP-14 and VAS scale', 'rCAL gain', 'OHIP-14 total score', 'PPD and relative clinical attachment level (rCAL', 'Defect resolution (DR) and bone filling (BF', 'quality of life']","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0893442', 'cui_str': 'enamel matrix proteins'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0628703,"RESULTS


PPD and relative clinical attachment level (rCAL) improved for all groups during follow-up (p ≤ 0.05), and AgP+CS/EMD presented a higher rCAL gain (2.4 ± 1.0 mm) when compared to AgP control patients (1.6 ± 1.6 mm, p ≤ 0.05) after 12 months.","[{'ForeName': 'Ana Lívia', 'Initials': 'AL', 'LastName': 'Fileto Mazzonetto', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}, {'ForeName': 'Renato Corrêa Viana', 'Initials': 'RCV', 'LastName': 'Casarin', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Department of Diagnosis and Surgery, State University of São Paulo, Eng. Francisco José Longo Ave 777, 12245-000, São José dos Campos, Brazil.'}, {'ForeName': 'Naira Maria Rebelatto Bechara', 'Initials': 'NMRB', 'LastName': 'Andere', 'Affiliation': 'Department of Diagnosis and Surgery, State University of São Paulo, Eng. Francisco José Longo Ave 777, 12245-000, São José dos Campos, Brazil.'}, {'ForeName': 'Cássia Fernandes', 'Initials': 'CF', 'LastName': 'Araújo', 'Affiliation': 'Department of Diagnosis and Surgery, State University of São Paulo, Eng. Francisco José Longo Ave 777, 12245-000, São José dos Campos, Brazil.'}, {'ForeName': 'Rafaela Videira Clima', 'Initials': 'RVC', 'LastName': 'da Silva', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}, {'ForeName': 'Javier Eduardo Vivanco', 'Initials': 'JEV', 'LastName': 'Purisaca', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}, {'ForeName': 'Enilson Antonio', 'Initials': 'EA', 'LastName': 'Sallum', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}, {'ForeName': 'Antonio Wilson', 'Initials': 'AW', 'LastName': 'Sallum', 'Affiliation': 'Department of Prosthesis and Periodontology, State University of Campinas, Limeira Ave 901, 13414-903, Piracicaba, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0493']
1573,33107645,Behavioural intervention to reduce disruptive behaviours in adult day care centres users: A randomizsed clinical trial (PROCENDIAS study).,"AIM


This study assesses the effect of an intervention to reduce the disruptive behaviours (DB) presented by care recipient users of adult day care centres (ADCC), thereby reducing caregiver overload. While ADCC offer beneficial respite for family caregivers, the DB that many care recipients show promote resistance to attending these centres, which can be a great burden on their family caregivers.
DESIGN


Randomized controlled clinical trial.
METHODS


The study was carried out with 130 family caregivers of people attending seven ADCC in the municipality of Salamanca (Spain), randomly distributed into intervention and control groups. The intervention was applied across eight sessions, one per week, in groups of 8-10 people where caregivers were trained in the Antecedent-Behavior-Consequence (ABC) model of functional behaviour analysis. The primary outcome was the reduction of DB measured with the Revised Memory and Behavior Problems Checklist (RMBPC).
RESULTS


An average reduction in the RMBPC of 4.34 points was obtained in the intervention group after applying the intervention (p < 0.01 (U de Mann-Whitney); Cohen d = 1.00); furthermore, differences were found in the Center for Epidemiologic Studies Depression Scale (CES-D) (U = -2.67; p = 0.008; Cohen d = 0.50) and in the Short Zarit Burden Interview (Short ZBI) (t = -4.10; p < 0.01; Cohen d = 0.98).
CONCLUSION


The results obtained suggest that the implementation of this intervention could reduce both the frequency of DB occurrence and the reaction of the caregiver to their appearance. Improvement was also noted in the results regarding overload and emotional state of the family caregiver.
IMPACT


To our knowledge, this is the first randomized clinical trial to show that an intervention based on the ABC model could reduce the frequency and reaction of DB of care recipients in ADCC increasing their quality of life, and improving the mental health and overload of their family caregivers.",2020,An average reduction in the RMBPC of 4.34 points was obtained in the intervention group after applying the intervention (p < 0.01 (U de Mann-Whitney);,"['care recipient users of adult day care centres (ADCC', '130 family caregivers of people attending seven ADCC in the municipality of Salamanca (Spain', 'adult day care centres users']",['Behavioural intervention'],"['Short Zarit Burden Interview (Short ZBI', 'disruptive behaviours (DB', 'reduction of DB measured with the Revised Memory and Behavior Problems Checklist (RMBPC', 'disruptive behaviours', 'overload and emotional state of the family caregiver', 'frequency of DB occurrence']","[{'cui': 'C1268939', 'cui_str': 'Adult day care center'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0475482', 'cui_str': 'Behavior problem checklist'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",130.0,0.0614628,An average reduction in the RMBPC of 4.34 points was obtained in the intervention group after applying the intervention (p < 0.01 (U de Mann-Whitney);,"[{'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Tamayo-Morales', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Salamanca, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Patino-Alonso', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Statistics, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Losada', 'Affiliation': 'Psychology Department, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mora-Simón', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Basic Psychology, Psychology and Behavioral Sciences Methodology, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Unzueta-Arce', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Basic Psychology, Psychology and Behavioral Sciences Methodology, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'González-Sánchez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gómez-Marcos', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Medicine, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'García-Ortiz', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Biomedical and Diagnostic Sciences, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodríguez-Sánchez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Department of Medicine, University of Salamanca, Salamanca, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14618']
1574,33107666,Comparison of cognitive-behavioral therapy and yoga for the treatment of late-life worry: A randomized preference trial.,"BACKGROUND


The purpose of this study was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes.
METHODS


A randomized preference trial of CBT and yoga was conducted in community-dwelling adults 60 years or older, who scored 26 or above on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A). CBT consisted of 10 weekly telephone sessions. Yoga consisted of 20 biweekly group yoga classes. The primary outcome was worry (PSWQ-A); the secondary outcomes were anxiety (PROMIS-Anxiety) and sleep (Insomnia Severity Index [ISI]). We examined both preference effects (average effect for those who received their preferred intervention [regardless of whether it was CBT or yoga] minus the average for those who did not receive their preferred intervention [regardless of the intervention]) and selection effect (which addresses the question of whether there is a benefit to getting to select one intervention over the other, and measures the effect on outcomes of self-selection to a specific intervention).
RESULTS


Five hundred older adults were randomized to the randomized trial (125 each in CBT and yoga) or the preference trial (120 chose CBT; 130 chose yoga). In the randomized trial, the intervention effect of yoga compared with CBT adjusted for baseline psychotropic medication use, gender, and race was 1.6 (-0.2, 3.3), p = .08 for the PSWQ-A. Similar results were observed with PROMIS-Anxiety (adjusted intervention effect: 0.3 [-1.5, 2.2], p = .71). Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]). Estimated in the combined data set (N = 500), the preference and selection effects were not significant for the PSWQ-A, PROMIS-Anxiety, and ISI. Of the 52 adverse events, only two were possibly related to the intervention. None of the 26 serious adverse events were related to the study interventions.
CONCLUSIONS


CBT and yoga were both effective at reducing late-life worry and anxiety. However, a greater impact was seen for CBT compared with yoga for improving sleep. Neither preference nor selection effects was found.",2020,"Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]).","['Five hundred older adults', 'late-life worry', 'community-dwelling adults 60 years or older, who scored 26 or above on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A']","['CBT', 'CBT and yoga', 'cognitive-behavioral therapy and yoga', 'cognitive-behavioral therapy (CBT) and yoga']","['late-life worry, anxiety, and sleep', 'late-life worry and anxiety', 'PROMIS-Anxiety', 'ISI', 'PSWQ-A, PROMIS-Anxiety, and ISI', 'worry (PSWQ-A); the secondary outcomes were anxiety (PROMIS-Anxiety) and sleep (Insomnia Severity Index [ISI']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",500.0,0.0581077,"Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]).","[{'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Brenes', 'Affiliation': 'Department of Internal Medicine,\xa0Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Divers', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Hargis', 'Affiliation': 'Department of Internal Medicine,\xa0Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Danhauer', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]",Depression and anxiety,['10.1002/da.23107']
1575,33107755,Do Volume of Injection and Learning Curve Influence the Results of Endoscopic Correction of Vesicoureteric Reflux Using Dextranomer/Hyaluronic Acid? A Single Surgeon Experience.,"Background:  Available reports regarding the technical factors for successful endoscopic treatment (ET) of vesicoureteric reflux (VUR) using dextranomer/hyaluronic acid copolymer are inconclusive. We studied single-surgeon data to evaluate the association of injected volume and surgeon experience with success after ET for VUR.  Materials and Methods:  Fifty-eight children (87 ureters) with grades 2-4 primary VUR were included. Success was defined as complete resolution of reflux on follow-up imaging. Volume of injection between success and failed groups was analyzed; volume of injection was further studied using receiver operating characteristic curve (ROC) analysis. Patients were then divided into two groups: group 1 (early experience) and group 2 (later experience). Both groups were compared for age, grade of reflux, volume of injection, and success.  Results:  Overall success of one injection was 76%. The mean volume of injection was significantly larger in successful ureters than failed ureters ( P  = .008). On ROC analysis, the volume of 0.75 mL (area under curve 0.747, 95% confidence interval 0.60-0.89) had a good discriminative ability to predict success of the injection procedure. Furthermore, a volume cutoff of 0.8 mL demonstrated significant influence on success (success 14/25 ureters for <0.8 mL and 36/42 ureters for 0.8 mL or more volume of injection,  P  = .0097), whereas no difference in success was observed with a cutoff volume of 0.9 mL ( P  = .2480). When the patients were divided into two groups based on surgeon experience, group 2 demonstrated better success than group 1 (84% versus 65%,  P  = .04). Both groups were comparable for age ( P  = .09), grade of reflux (0.46) and the median volume of injection was similar (0.8 mL) in both the groups.  Conclusions:  We found that a minimal volume of 0.75 mL dextranomer/hyaluronic acid injection may be required to achieve success of ET in moderate grade primary VUR. Success also improved with increasing surgeon experience.",2020,The mean volume of injection was significantly larger in successful ureters than failed ureters ( P  = .008).,['Fifty-eight children (87 ureters) with grades 2-4 primary VUR were included'],['dextranomer/hyaluronic acid copolymer'],"['median volume of injection', 'Overall success of one injection', 'mean volume of injection', 'grade of reflux', 'complete resolution of reflux']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4551858', 'cui_str': 'Vesicoureteral Reflux 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0057621', 'cui_str': 'dextranomer'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0596383', 'cui_str': 'Copolymer'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",58.0,0.0367258,The mean volume of injection was significantly larger in successful ureters than failed ureters ( P  = .008).,"[{'ForeName': 'Vvs', 'Initials': 'V', 'LastName': 'Chandrasekharam', 'Affiliation': ""Pediatric Surgery, Pediatric Urology and MAS, Ankura Hospitals for Women and Children and Little Star Children's Hospitals, Hyderabad, India.""}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0590']
1576,33107803,Pulmonary Metastasectomy for Colorectal Cancer: Randomized Controlled Trial.,,2020,,['Colorectal Cancer'],[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.182709,,"[{'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Clinical and Interventional Trials Unit and.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, Gower Street, London WC1E 6BT, England.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}]",Radiology,['10.1148/radiol.2020202862']
1577,33107832,A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial.,"BACKGROUND


Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life.
OBJECTIVE


This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years.
METHODS


This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys.
RESULTS


The trial recruitment started in May 2020. Data collection is currently ongoing.
CONCLUSIONS


This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/23655.",2020,"The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study.","['young people', '378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components', 'young adults aged 18 to 25 years']","['DBT-informed smartphone app', 'Mobile Health Intervention (LifeBuoy App', 'dialectical behavior therapy (DBT', 'LifeBuoy']","['suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS', 'levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking', 'suicidal thoughts and behaviors, depression, anxiety, and psychological distress', 'suicidal behavior, depression, anxiety, psychological distress, and general mental well-being']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",378.0,0.13898,"The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McGillivray', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Quincy Jj', 'Initials': 'QJ', 'LastName': 'Wong', 'Affiliation': 'School of Psychology, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Iana', 'Initials': 'I', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Australian National University, Canberra, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}]",JMIR research protocols,['10.2196/23655']
1578,33107835,Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression: Protocol for Patient-Centered Randomized Controlled Pilot Trial.,"BACKGROUND


Major depression is a severe, disabling, and potentially lethal clinical disorder. Only about half of patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder (MDD) remain refractory to any treatment intervention. By the time that a patient has experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered is below 10%. Repetitive transcranial magnetic stimulation (rTMS) is considered a treatment option for patients with MDD who are refractory to antidepressant treatment. It is not currently known if the addition of internet-delivered cognitive-behavioral therapy (iCBT) enhances patients' responses to rTMS treatments.
OBJECTIVE


This study will evaluate the initial comparative clinical effectiveness of rTMS with and without iCBT as an innovative patient-centered intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD).
METHODS


This study is a prospective, two-arm randomized controlled trial. In total, 100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada, will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT. Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months. The primary outcome measure will be the mean change to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses.
RESULTS


We expect the results of the study to be available in 24 months. We hypothesize that participants enrolled in the study who receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone.
CONCLUSIONS


The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT).
TRIAL REGISTRATION


ClinicalTrials.gov NCT0423965; https://clinicaltrials.gov/ct2/show/NCT04239651.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18843.",2020,"Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months.","['100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada', 'participants diagnosed with treatment-resistant depression (TRD', 'patients with MDD who are refractory to antidepressant treatment', 'Resistant Depression', 'participants enrolled in the study who receive']","['Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy', 'psychotherapy with rTMS', 'rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT', 'Repetitive transcranial magnetic stimulation (rTMS', 'cognitive-behavioral therapy (iCBT', 'rTMS plus iCBT', 'rTMS', 'rTMS with and without iCBT']","['complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes', 'mean change to scores on the Hamilton Depression Rating Scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",100.0,0.113129,"Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months.","[{'ForeName': 'Rabab M', 'Initials': 'RM', 'LastName': 'Abou El-Magd', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Obuobi-Donkor', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Medard K', 'Initials': 'MK', 'LastName': 'Adu', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lachowski', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Surekha', 'Initials': 'S', 'LastName': 'Duddumpudi', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mobolaji A', 'Initials': 'MA', 'LastName': 'Lawal', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adegboyega O', 'Initials': 'AO', 'LastName': 'Sapara', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Achor', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kouzehgaran', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Hegde', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Chew', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Mach', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Daubert', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Urichuk', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Surood', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Greenshaw', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vincent Israel Opoku', 'Initials': 'VIO', 'LastName': 'Agyapong', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/18843']
1579,33107836,Understanding the Extent of Adolescents' Willingness to Engage With Food and Beverage Companies' Instagram Accounts: Experimental Survey Study.,"BACKGROUND


Social media platforms have created a new advertising frontier, yet little is known about the extent to which this interactive form of advertising shapes adolescents' online relationships with unhealthy food brands.
OBJECTIVE


We aimed to understand the extent to which adolescents' preferences for Instagram food ads are shaped by the presence of comments and varying numbers of ""likes."" We hypothesized that adolescents would show the highest preferences for ads with more ""likes"" and comments. We predicted that these differences would be greater among adolescents who were ""heavy social media users"" (ie, >3 hours daily) vs ""light social media users"" (ie, <3 hours daily).
METHODS


We recruited Black and non-Latinx White adolescents (aged 13-17 years; N=832) from Dynata, a firm that maintains online participant panels. Participants completed an online survey in which they were randomized to view and rate Instagram food ads that either did or did not show comments. Within each condition, adolescents were randomized to view 4 images that had high (>10,000), medium (1000-10,000), or low (<100) numbers of ""likes."" Adolescents reported ad preferences and willingness to engage with the brand.
RESULTS


Adolescents rated ads with medium or high numbers of ""likes"" higher than ads with few ""likes"" (P=.001 and P=.002, respectively). Heavy social media users (>3 hours/day) were 6.366 times more willing to comment on ads compared to light users (P<.001).
CONCLUSIONS


Adolescents interact with brands in ways that mimic interactions with friends on social media, which is concerning when brands promote unhealthy products. Adolescents also preferred ads with many ""likes,"" demonstrating the power of social norms in shaping behavior. As proposed in 2019, the Children's Online Privacy and Protection Act should expand online advertising restrictions to include adolescents aged 12 to 16 years.",2020,"Heavy social media users (>3 hours/day) were 6.366 times more willing to comment on ads compared to light users (P<.001).
","['adolescents aged 12 to 16 years', 'We recruited Black and non-Latinx White adolescents (aged 13-17 years; N=832) from Dynata, a firm that maintains online participant panels']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],[],,0.0742569,"Heavy social media users (>3 hours/day) were 6.366 times more willing to comment on ads compared to light users (P<.001).
","[{'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Lutfeali', 'Affiliation': 'Stanford Graduate School of Business, Palo Alto, CA, United States.'}, {'ForeName': 'Tisheya', 'Initials': 'T', 'LastName': 'Ward', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Tenay', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Arshonsky', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Azizi', 'Initials': 'A', 'LastName': 'Seixas', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Dalton', 'Affiliation': 'Dartmouth Geisel School of Medicine, Lebanon, NH, United States.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bragg', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}]",JMIR public health and surveillance,['10.2196/20336']
1580,33107921,Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial.,"Importance


Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions.
Objective


To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors associated with response to electroacupuncture vs placebo in treating chronic low back pain.
Design, Setting, and Participants


This double-blind randomized clinical trial was conducted between August 2, 2016, and December 18, 2018, at a single center in Stanford, California. Primary outcomes were collected at approximately 2 weeks before and after intervention. Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy. Data analyses for this intent-to-treat study were conducted from June 2019 to June 2020.
Interventions


Twelve sessions of real or placebo (sham) electroacupuncture administered twice a week over 6 weeks.
Main Outcomes and Measures


The main outcome was change in pain severity from baseline to 2 weeks after completion of treatment, measured by the National Institutes of Health PROMIS pain intensity scale. A secondary outcome was change in the Roland Morris Disability Questionnaire (RMDQ). Baseline factors potentially associated with these outcomes included psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race).
Results


A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women) were randomized to real electroacupuncture and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women) were randomized to sham electroacupuncture. At baseline, the mean (SD) PROMIS T-score was 50.49 (3.36) in the real electroacupuncture group and 51.71 (4.70) in the sham acupuncture group, and the mean (SD) RMDQ score was 10.16 (4.76) in the real electroacupuncture group and 10.03 (5.45) in the sham acupuncture group. After adjusting for baseline pain scores, there was no statistically significant difference between groups in change in T-scores 2 weeks after completion of treatment (real electroacupuncture: -4.33; 95% CI, -6.36 to -2.30; sham acupuncture: -2.90; 95% CI, -4.85 to -0.95; difference: -2.09; 95% CI, -4.27 to 0.09; P = .06). After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01). Within the real electroacupuncture group, effective coping at baseline was associated with greater RMDQ reduction (r = -0.32; 95% CI, -0.54 to -0.05; P = .02), and White race was associated with worse outcomes in PROMIS score (β = 3.791; 95% CI, 0.616 to 6.965; P = .02) and RMDQ (β = 2.878; 95% CI, 0.506 to 5.250; P = .02).
Conclusions and Relevance


This randomized clinical trial found no statistically significant difference in change in PROMIS pain score in real electroacupuncture vs sham electroacupuncture. There was a statistically significant treatment effect for the secondary outcome of RMDQ compared with sham electroacupuncture. Effective coping skills and non-White race were associated with response to electroacupuncture.
Trial Registration


ClinicalTrials.gov Identifier: NCT02890810.",2020,"After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01).","['and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women', 'A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women', 'Adults With Chronic Low Back Pain', 'Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy', 'adults with chronic low back pain', 'August 2, 2016, and December 18, 2018, at a single center in Stanford, California']","['Electroacupuncture', 'sham electroacupuncture', 'electroacupuncture vs sham electroacupuncture', 'electroacupuncture', 'real electroacupuncture vs placebo', 'electroacupuncture vs placebo', 'real electroacupuncture', 'placebo', 'acupuncture', 'real or placebo (sham) electroacupuncture']","['mean (SD) PROMIS T-score', 'Pain Severity', 'National Institutes of Health PROMIS pain intensity scale', 'Roland Morris Disability Questionnaire (RMDQ', 'baseline pain scores', ""psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race"", 'pain and disability', 'mean (SD) RMDQ score', 'PROMIS pain score', 'RMDQ reduction', 'pain severity', 'RMDQ']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",121.0,0.721707,"After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01).","[{'ForeName': 'Jiang-Ti', 'Initials': 'JT', 'LastName': 'Kong', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Chelcie', 'Initials': 'C', 'LastName': 'Puetz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Haynes', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Randall S', 'Initials': 'RS', 'LastName': 'Stafford', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manber', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.22787']
1581,33107945,Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial.,"Importance


Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion.
Objective


To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation.
Design, Setting, and Participants


The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N = 350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019.
Interventions


Patients were randomly assigned to catheter ablation alone (n = 158) or catheter ablation combined with vein of Marshall ethanol infusion (n = 185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures.
Main Outcomes and Measures


The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others.
Results


Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P = .04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P = .01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P = .04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P < .001) were significantly improved in vein of Marshall-treated patients. Adverse events were similar between groups.
Conclusions and Relevance


Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01898221.",2020,"At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%];","['343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial', 'Participants\n\n\nThe Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States', 'patients with persistent AF', 'Persistent Atrial Fibrillation', 'persistent atrial fibrillation (AF', 'Patients (N\u2009=\u2009350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018']","['catheter ablation alone', 'Catheter Ablation Alone', 'Vein of Marshall Ethanol Infusion vs', 'Catheter Ablation', 'Vein of Marshall ethanol', 'catheter ablation alone (n\u2009=\u2009158) or catheter ablation combined with vein of Marshall ethanol infusion (n\u2009=\u2009185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures', 'catheter ablation combined with vein of Marshall ethanol infusion', 'vein of Marshall ethanol infusion']","['AF burden, freedom from AF after multiple procedures, perimitral block, and others', 'success achieving perimitral block', 'Adverse events', 'proportion of patients with freedom from AF/atrial tachycardia', 'likelihood of remaining free of AF or atrial tachycardia', 'freedom from AF or atrial tachycardia', 'AF burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",343.0,0.20786,"At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%];","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Valderrábano', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Leif E', 'Initials': 'LE', 'LastName': 'Peterson', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Swarup', 'Affiliation': 'Arizona Heart Rhythm Center, Phoenix.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Schurmann', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Makkar', 'Affiliation': 'Arizona Heart Rhythm Center, Phoenix.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Doshi', 'Affiliation': 'Keck-USC University Hospital, University of Southern California, Los Angeles.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St Joseph's Hospital, Emory University, Atlanta, Georgia.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Athill', 'Affiliation': 'Sharp Memorial Hospital, San Diego, California.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Ellenbogen', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St David's Medical Center, Austin.""}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Koneru', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Amish S', 'Initials': 'AS', 'LastName': 'Dave', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Giorgberidze', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Afshar', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Guthrie', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bunge', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}]",JAMA,['10.1001/jama.2020.16195']
1582,33107977,The impact of mucosal phenotype on marginal bone levels around tissue level implants: A prospective controlled trial.,"BACKGROUND


The aim of this one-year prospective clinical trial was to compare clinical parameters and marginal bone levels around tissue level implants with a partially smooth collar between patients with thin (≤ 2 mm) and thick (> 2 mm) vertical mucosal phenotypes.
METHODS


Thirty patients needing a single dental implant were recruited and allocated to thin (n = 14) or thick (n = 16) phenotype groups. Post-restoration, clinical (probing depth, recession, width of keratinized mucosa, bleeding on probing, suppuration, implant mobility, plaque index, and gingival index) and radiographic bone level measurements were recorded at different timepoints for one year.
RESULTS


Twenty-six patients (13 per group) completed the one-year examination. No implants were lost (100% survival rate). There were no significant differences (p > 0.05) between thin and thick vertical mucosal phenotypes for any clinical parameter or for the radiographic marginal bone level.
CONCLUSION


Tissue level implants at one year of function placed in thin vertical mucosa achieved similar clinical parameters and radiographic marginal bone levels as those in thick tissue. The formation of the peri-implant supracrestal tissue height plays a key role in MBL than mucosal thickness in tissue level implant. This article is protected by copyright. All rights reserved.",2020,"There were no significant differences (p > 0.05) between thin and thick vertical mucosal phenotypes for any clinical parameter or for the radiographic marginal bone level.
","['patients with thin (≤ 2 mm) and thick (> 2 mm) vertical mucosal phenotypes', 'Thirty patients needing a single dental implant were recruited and allocated to thin (n = 14) or thick (n = 16) phenotype groups']",[],"['marginal bone levels', 'radiographic marginal bone level', 'Post-restoration, clinical (probing depth, recession, width of keratinized mucosa, bleeding on probing, suppuration, implant mobility, plaque index, and gingival index) and radiographic bone level measurements', 'radiographic marginal bone levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",30.0,0.0492092,"There were no significant differences (p > 0.05) between thin and thick vertical mucosal phenotypes for any clinical parameter or for the radiographic marginal bone level.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garaicoa-Pazmino', 'Affiliation': 'Department of Periodontology, School of Dentistry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Mendonca', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ou', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'Hsun-Liang', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mailoa', 'Affiliation': 'Private Practice, Makassar, Indonesia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Suarez-Lopez Del Amo', 'Affiliation': 'Private Practice, Tacoma, Washington, USA.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0458']
1583,33108030,One-year aerobic interval training in outpatients with schizophrenia: A randomized controlled trial.,"Although aerobic interval training (AIT) is recognized to attenuate the risk of cardiovascular disease (CVD) and premature mortality, it appears that it rarely arrives at patients' doorsteps. Thus, this study investigated 1-year effects and feasibility of AIT delivered with adherence support in collaborative care of outpatients with schizophrenia. Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals]) years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10) were randomized to either a collaborative care group provided with municipal transportation service and training supervision (walking/running 4 × 4 minutes at ~90% of peak heart rate; HR peak ) 2 d wk -1  at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training. Directly assessed peak oxygen uptake (      V   ˙   O   2   peak      ) increased in the TG after 3 months (2.3 [0.6-4.4] mL kg -1  min -1 , Cohen's d = 0.33[-4.63 to 4.30], P = 0.04), 6 months (2.7 [0.5-4.8] mL kg -1  min -1 , Cohen's d = 0.42[-4.73 to 4.11], P = 0.02) and 1 year (4.6 [2.3-6.8] mL kg -1  min -1 , Cohen's d = 0.70[-4.31 to 4.10], P < 0.001) compared to the CG. One-year cardiac effects revealed higher HR peak  (7 [2-11] b min -1 , Cohen's d = 0.34[-8.48 to 8.65], P = 0.01), while peak stroke volume tended to be higher (0.9 [-0.2 to 2.0] mL b -1 , Cohen's d = 0.35[-1.62 to 2.01], P = 0.11) in the TG compared to the CG. Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose) remained unaltered in both groups. One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG). AIT was successfully included in long-term collaborative care of outpatients with schizophrenia and yielded improved      V   ˙   O   2   peak      , advocating this model for aerobic capacity improvement and CVD risk reduction in future treatment.",2020,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"['years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10', 'outpatients with schizophrenia and yielded improved      V', 'outpatients with schizophrenia', 'Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals']","['collaborative care group provided with municipal transportation service and training supervision (walking/running 4\xa0×\xa04\xa0minutes at ~90% of peak heart rate; HR peak ) 2\xa0d\xa0wk -1  at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training', 'aerobic interval training', 'aerobic interval training (AIT']","['Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose', 'aerobic capacity improvement and CVD risk reduction', 'One-year AIT adherence rates', 'peak oxygen uptake (      V', 'peak stroke volume', 'HR peak']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",48.0,0.0540508,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"[{'ForeName': 'Mathias Forsberg', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Ismail Cüneyt', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Solveig Klæbo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Vedul-Kjelsaas', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13808']
1584,33108123,"An Herbal Formulation of Jiawei Xiaoyao for the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Placebo-Controlled, Clinical Trial.","INTRODUCTION


To investigate the efficacy and safety of an herbal formulation of Jiawei Xiaoyao (JX) on gastrointestinal symptoms in patients with functional dyspepsia (FD) who had previously rejected standard therapies of proton pump inhibitors, H2 blockers, or Helicobacter pylori eradication.
METHODS


A total of 144 adult men and women with FD according to the Rome III criteria were recruited at 9 sites in China from August 2017 to April 2019. Participants were randomized to receive either a JX pill or placebo (12 g/d, 6 g twice a day) for 4 weeks. The primary end point was the change in the total Gastrointestinal Symptom Score (GIS) from baseline to week 4. The secondary end points included the scores on the Hamilton Depression Scale and the Hamilton Anxiety Scale. The safety outcomes included the results of the complete blood count, the liver function test, the renal function test, urinalysis, the fecal occult blood test, and an electrocardiogram.
RESULTS


Data from 141 patients (JX pill, n = 70; placebo, n = 71) were statistically analyzed. The mean ± SD of the GIS for the JX pill group at baseline and 4 weeks was 9.3 ± 3.1 and 3.8 ± 3.0, respectively; the mean ± SD of the GIS for the placebo group at baseline and 4 weeks was 9.5 ± 3.4 and 5.3 ± 4.4, respectively (change from baseline to 4 weeks in the JX pill group vs change from baseline in the control group, -1.3 points; P = 0.013). The JX pill group showed greater improvement in both the Hamilton Depression Scale and Hamilton Anxiety Scale scores from baseline to 4 weeks than the placebo group, but the difference was not significant. The total number of adverse events was 30 in the JX pill group vs 20 in the placebo group (P = 0.240).
DISCUSSION


The JX pill was superior to the placebo in terms of improving the GIS in patients with FD but did not significantly improve depression or anxiety symptoms. These findings suggest that the JX pill may have a positive effect on the resolution of gastrointestinal symptoms in patients with FD who are seeking alternative therapies.",2020,"The JX pill group showed greater improvement in both the Hamilton Depression Scale and Hamilton Anxiety Scale scores from baseline to 4 weeks than the placebo group, but the difference was not significant.","['patients with functional dyspepsia (FD) who had previously rejected standard therapies of proton pump inhibitors, H2 blockers, or Helicobacter pylori eradication', 'patients with FD', 'patients with FD who are seeking alternative therapies', '141 patients (JX pill, n = 70', '144 adult men and women with FD according to the Rome III criteria were recruited at 9 sites in China from August 2017 to April 2019', 'Functional Dyspepsia']","['JX pill or placebo', 'Jiawei Xiaoyao', 'placebo', 'herbal formulation of Jiawei Xiaoyao (JX', 'Placebo']","['Hamilton Depression Scale and Hamilton Anxiety Scale scores', 'gastrointestinal symptoms', 'mean ± SD of the GIS', 'total number of adverse events', 'efficacy and safety', 'resolution of gastrointestinal symptoms', 'complete blood count, the liver function test, the renal function test, urinalysis, the fecal occult blood test, and an electrocardiogram', 'depression or anxiety symptoms', 'total Gastrointestinal Symptom Score (GIS', 'scores on the Hamilton Depression Scale and the Hamilton Anxiety Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C4319517', 'cui_str': 'Order rejected'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0019593', 'cui_str': 'Histamine H2 receptor antagonist'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C1869284', 'cui_str': 'xiaoyao'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1869284', 'cui_str': 'xiaoyao'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",144.0,0.230204,"The JX pill group showed greater improvement in both the Hamilton Depression Scale and Hamilton Anxiety Scale scores from baseline to 4 weeks than the placebo group, but the difference was not significant.","[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""1Division of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; 2Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; 3Division of Gastroenterology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China; 4Division of Gastroenterology, Changsha People's Hospital, Changsha, China; 5Division of Gastroenterology, Gansu Second Provincial People's Hospital, Gansu, China; 6Division of Gastroenterology, Loudi Central Hospital, Hunan, China; 7Division of Gastroenterology, Hengyang Chinese Medicine Hospital, Hengyang, China; 8Division of Gastroenterology, Harrison International Peace Hospital, Hengshui, China; 9Division of Gastroenterology, Xiang Yang No. 1 People's Hospital, Xiangyang, China; 10Geriatric Department, Luoyang No. 1 Hospital of TCM, Luoyang, China; 11Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; 12Technology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.""}, {'ForeName': 'Peimin', 'Initials': 'P', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Shaofeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiangping', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Guixia', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000241']
1585,33108138,Improved outcomes utilizing a novel pectin-based pleural sealant following acute lung injury.,"BACKGROUND


Persistent air leaks after thoracic trauma are associated with significant morbidity. To evaluate a novel pectin sealant in a swine model of traumatic air leaks, we compared a pectin biopolymer with standard surgical and fibrin-based interventions.
METHODS


A standardized lung injury was created in male Yorkshire swine. Interventions were randomized to stapled wedge resection (n = 5), topical fibrin glue (n = 5), fibrin patch (n = 5), and a pectin sealant (n = 6). Baseline, preintervention and postintervention tidal volumes (TV) were recorded. Early success was defined as the return to near-normal TV (>95% of baseline). Late success was defined as no detectable air leak in the chest tube after chest closure.
RESULTS


There were no differences in injury severity between groups (mean TV loss, 62 ± 17 mL, p = 0.2). Early success was appreciated in 100% (n = 6) of the pectin interventions which was significantly better than the fibrin sealant (20%, n = 1), fibrin patch (20%, n = 1), and stapled groups (80%, n = 4, p = 0.01). The percent of return to baseline TV after sealant intervention was significantly increased in the pectin (98%) and staple arms (97%) compared with the fibrin sealant (91%) and fibrin patch arms (90%) (p = 0.02; p = 0.03). Late success was also improved with the pectin sealant: no air leak was detected in 83% of the pectin group compared with 40% in the stapled group (p = 0.008)-90% of the fibrin-based interventions resulted in continuous air leaks (p = 0.001).
CONCLUSION


Pectin-based bioadhesives effectively seal traumatic air leaks upon application in a porcine model. Further testing is warranted as they may provide a superior parenchymal-sparing treatment option for traumatic air leaks.",2020,"Late success was also improved with the pectin sealant: no air leak was detected in 83% of the pectin group compared with 40% in the stapled group (p = 0.008)-90% of the fibrin-based interventions resulted in continuous air leaks (p = 0.001).
","['swine model of traumatic air leaks', 'acute lung injury', 'A standardized lung injury was created in male Yorkshire swine']","['novel pectin sealant', 'stapled wedge resection', 'pectin sealant', 'Pectin-based bioadhesives', 'fibrin sealant', 'pectin biopolymer with standard surgical and fibrin-based interventions', 'pectin', 'novel pectin-based pleural sealant', 'topical fibrin glue', 'fibrin patch']","['Early success', 'percent of return to baseline TV', 'continuous air leaks', 'injury severity', 'air leak', 'Baseline, preintervention and postintervention tidal volumes (TV', 'Late success', 'fibrin patch']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030744', 'cui_str': 'Pectin'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0005554', 'cui_str': 'Biopolymer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]",,0.107812,"Late success was also improved with the pectin sealant: no air leak was detected in 83% of the pectin group compared with 40% in the stapled group (p = 0.008)-90% of the fibrin-based interventions resulted in continuous air leaks (p = 0.001).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuckelman', 'Affiliation': ""From the Madigan Army Medical Center (J.K., J.C., I.J., D.L., D.C., M.E., S.M.), Tacoma, Washington; and Laboratory of Adaptive and Regenerative Biology, Brigham & Women's Hospital (YY.Z., A.P., S.M.), Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Conner', 'Affiliation': ''}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lammers', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cuadrado', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eckert', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Mentzer', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002754']
1586,33104373,Do personal resources and strengths use increase work engagement? The effects of a training intervention.,"This study uses a quasi-experimental research design to investigate whether a personal resources intervention combined with strengths use can increase work engagement. Following job demands-resources theory, we argue that when employees strengthen their beliefs regarding how much control they have over their environment (i.e., increase their personal resources) and use their character strengths, they will be more engaged at work. The intervention focused specifically on impacting assertiveness, self-efficacy, and resilience. We hypothesized that the intervention would increase work engagement through an increase in personal resources. Participants were all enrolled for a personal resources training and were assigned to training intervention groups (n = 54) or waiting-list control groups (n = 48). Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement. In addition, process analyses using a bootstrapping procedure showed that in the intervention group (not in the control group), the intervention had a positive impact on changes in work engagement through changes in self-efficacy and resilience. We discuss the implications of these findings for job demands-resources theory, as well as the practical implications. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement.",[],"['training intervention groups (n = 54) or waiting-list control groups', 'training intervention', 'personal resources training']","['personal resources, strengths use, and work engagement', 'self-efficacy and resilience']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0172636,"Results of multivariate analyses of variance supported our hypotheses that the intervention increased personal resources, strengths use, and work engagement.","[{'ForeName': 'Arnold B', 'Initials': 'AB', 'LastName': 'Bakker', 'Affiliation': 'Center of Excellence for Positive Organizational Psychology.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'van Wingerden', 'Affiliation': 'Center of Excellence for Positive Organizational Psychology.'}]",Journal of occupational health psychology,['10.1037/ocp0000266']
1587,33104375,Recitation and listening to nursery rhymes in the familiarization with a literacy language in kindergarteners: Not kids' stuff.,"A large linguistic distance exists between spoken Arabic and the Modern Standard Arabic (MSA) the literary language (a diglosia). Novice readers, therefore, struggle with the complex orthography of Arabic as well as the mastering of MSA. Here, we tested whether structured activities in MSA would advance kindergarteners' MSA aptitude by the end of the school year. We examined two issues: (a) whether reciting nursery rhymes in MSA would be more effective in promoting language and preliteracy skills in kindergarteners compared to listening to the same texts, and (b) whether there are additional advantages for using texts directly referring to the alphabet. Thus, 136 kindergarteners ( M age  = 5:6; 61 girls), all native speakers of Arabic and with middle-low socioeconomic background, were assigned to a 10-session (2 months) program in 1 of 4 intervention conditions wherein nursery rhymes related/not related to the alphabet, were either repeatedly recited or listened to. The achievements of children in the intervention conditions were compared to those of peers that were given nonlinguistic activity of similar length (control). The four intervention groups improved their performance at the postintervention assessment in all tests of MSA aptitude and outperformed the control group in receptive and expressive vocabulary and listening comprehension. Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity. Our results highlight the contribution of structured interventions based on rhyme repetition to MSA proficiency of kindergarteners. Moreover, the results suggest that reciting may be superior to listening in advancing language proficiency in preschoolers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity.","['136 kindergarteners ( M age  = 5:6; 61 girls), all native speakers of Arabic and with middle-low socioeconomic background']","['10-session (2 months) program in 1 of 4 intervention conditions wherein nursery rhymes related/not related to the alphabet, were either repeatedly recited or listened to']","['tests assessing vocabulary and morpho-syntactic sensitivity', 'receptive and expressive vocabulary and listening comprehension']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0323245', 'cui_str': 'Morpho'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.0155686,"Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity.","[{'ForeName': 'Hazar', 'Initials': 'H', 'LastName': 'Eghbaria-Ghanamah', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Rafat', 'Initials': 'R', 'LastName': 'Ghanamah', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Shalhoub-Awwad', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Adi-Japha', 'Affiliation': 'School of Education, Bar-Ilan University.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol Department of Neurobiology, Brain-Behavior Research Center, University of Haifa.'}]",Developmental psychology,['10.1037/dev0001124']
1588,33104433,SECUREment bundles to prevent peripheral intravenous catheter failure-the SECURE-PIVC trial: study protocol for a pilot randomized controlled trial.,"INTRODUCTION


Peripheral intravenous catheters (PIVCs) are widely used, but failure is unacceptably common with up to 69% failing before treatment is complete. PIVC securement reduces failure, but the optimal way to achieve this is unclear. Tapes and supplementary securement products are widely used, however rigorous testing of these to reduce PIVC failure remains unexplored.
METHODS AND ANALYSIS


In adult medical-surgical wards at a tertiary hospital, this pilot randomized controlled trial tests standard care (bordered polyurethane dressing plus nonsterile tape over the extension tubing) against two securement interventions (intervention one: standard care plus two sterile tape strips over the PIVC hub; intervention two: intervention one plus a tubular bandage). Patients >18 years of age requiring a PIVC for >24 hours are eligible. Patients with laboratory-confirmed positive blood cultures within 24 hours of screening, known allergy to study products, current or high-risk of skin tear, or non-English speaking without interpreter are excluded. Sample size is 35 per trial arm, and central randomization is computer-generated with allocation concealed until entry. Patients and clinical staff cannot be blinded to treatment allocation. However, infection outcomes are assessed by a blinded investigator. Primary outcome is study feasibility. Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost) are compared between groups. Feasibility outcomes are reported descriptively.
ETHICS AND TRIAL COMMENCEMENT


Ethical approvals were received from Royal Brisbane and Women's Hospital (HREC/18/QRBW/44571) and Griffith University (2018/1000). Trial commencement was May 2019.  Trial registration:  ACTRN12619000026123.",2020,"Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost) are compared between groups.","[""Ethical approvals were received from Royal Brisbane and Women's Hospital (HREC/18/QRBW/44571) and Griffith University (2018/1000"", 'adult medical-surgical wards at a tertiary hospital', 'Patients >18 years of age requiring a PIVC for >24 hours are eligible', 'Patients with laboratory-confirmed positive blood cultures within 24 hours of screening, known allergy to study products, current or high-risk of skin tear, or non-English speaking without interpreter are excluded']",['standard care (bordered polyurethane dressing plus nonsterile tape over the extension tubing) against two securement interventions (intervention one: standard care plus two sterile tape strips'],"['Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost']","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0877377', 'cui_str': 'Tear of skin'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.245882,"Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost) are compared between groups.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Corley', 'Affiliation': 'Adjunct Senior Research Fellow position with the AVATAR group at Menzies Health Institute QLD, Griffith University.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Ullman', 'Affiliation': ""NHMRC Fellow and Associate Professor at Griffith University, and Honorary Research Fellow at the Queensland Children's Hospital and the Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': ""Nursing Director, Research, The Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Larsen', 'Initials': 'L', 'LastName': 'Emily N', 'Affiliation': 'Senior Research Assistant with the AVATAR Group, Griffith University, Australia.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Mihala', 'Affiliation': 'Centre for Applied Health Economics (CAHE) and the AVATAR Group.'}, {'ForeName': 'Patrick N A', 'Initials': 'PNA', 'LastName': 'Harris', 'Affiliation': 'Infectious Disease Physician, Medical Microbiologist and NHMRC Early Career Fellow at The University of Queensland Centre for Clinical Research (UQCCR).'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'AVATAR Group.'}]",British journal of nursing (Mark Allen Publishing),['10.12968/bjon.2020.29.19.S40']
1589,33104444,Surgical prehabilitation using mobile health coaching in patients with obesity: A pilot study.,"Many patients spend months waiting for elective procedures, and many have significant modifiable risk factors that could contribute to an increased risk of perioperative morbidity and mortality. The minimal direct contact that usually occurs with healthcare professionals during this period represents a missed opportunity to improve patient health and surgical outcomes. Patients with obesity comprise a large proportion of the surgical workload but are under-represented in prehabilitation studies. Our study piloted a mobile phone based, multidisciplinary, prehabilitation programme for patients with obesity awaiting elective surgery. A total of 22 participants were recruited via the Wollongong Hospital pre-admissions clinic in New South Wales, Australia, and 18 completed the study. All received the study intervention of four text messages per week for six months. Questionnaires addressing the self-reported outcome measures were performed at the start and completion of the study. Forty percent of participants lost weight and 40% of smokers decreased their cigarette intake over the study. Sixty percent reported an overall improved health score. Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients. The cost was A$1.20 per patient per month. Our study showed improvement in some of the risk factors for perioperative morbidity and mortality. With improved methods to increase enrolment, our overall impression is that text message-based mobile health prehabilitation may be a feasible, cost-effective and worthwhile intervention for patients with obesity.",2020,"Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients.","['22 participants were recruited via the Wollongong Hospital pre-admissions clinic in New South Wales, Australia, and 18 completed the study', 'Patients with obesity comprise a large proportion of the surgical workload but are under-represented in prehabilitation studies', 'patients with obesity awaiting elective surgery', 'patients with obesity']",['Surgical prehabilitation using mobile health coaching'],"['cigarette intake', 'health score', 'perioperative morbidity and mortality']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",22.0,0.050224,"Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients.","[{'ForeName': 'Kasia', 'Initials': 'K', 'LastName': 'Kulinski', 'Affiliation': 'Department of Anaesthesia, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Smith', 'Affiliation': 'Department of Anaesthesia, Wollongong Hospital, Wollongong, Australia.'}]",Anaesthesia and intensive care,['10.1177/0310057X20947731']
1590,33104452,Voice bubbling therapy for vocal cord dysfunction in difficult-to-treat asthma - a pilot study.,"OBJECTIVE


Dysfunctional breathing often coexists with asthma and complicates asthma control, especially in difficult-to-treat asthma. Voice bubbling therapy (VBT) by a specialized speech therapist may influence the breathing pattern. This pilot study investigated the effect of voice bubbling therapy (VBT) in participants with difficult-to-treat asthma, who fulfilled criteria for dysfunctional breathing pattern.
METHOD


Twenty-four patients were randomized between VBT and usual care (UC). VBT is blowing into a glass (resonance) tube (28 cm in length, 0.9 cm inner diameter) which ends in a bowl of water (1.5 litre). Lung function, capillary blood gas and questionnaires were measured at baseline, at 6 and 18 weeks of follow up.
RESULTS


No difference in ACQ and quality of life was found after VBT compared to UC group. However, after six weeks of bubbling therapy, pCO2 levels measured in capillary blood gas were higher (baseline median (IQR) pCO2 = 33.00 (17.25 - 38.6) mmHg; week 6 pCO2 = 36.00 (29.00 - 42.3) mmHg)  p = 0.01.  Moreover, ΔpCO2 (baseline - 18 weeks of follow up) was significantly correlated with ΔAQLQ (rs = 0.78,  p = 0.02 ).
CONCLUSION


VBT in participants with difficult-to-treat asthma resulted in a higher average pCO2 level, indicating the treatment may improve hyperventilation. However, this did not improve asthma control or quality of life. VBT may have value for a better management of asthma related symptoms.",2020,"Moreover, ΔpCO2 (baseline - 18 weeks of follow up) was significantly correlated with ΔAQLQ (rs = 0.78,  p = 0.02 ).
","['participants with difficult-to-treat asthma, who fulfilled criteria for dysfunctional breathing pattern', 'Twenty-four patients were randomized between']","['VBT', 'Voice bubbling therapy (VBT', 'Voice bubbling therapy', 'VBT and usual care (UC', 'voice bubbling therapy (VBT']","['pCO2 levels', 'Lung function, capillary blood gas and questionnaires', 'average pCO2 level', 'ACQ and quality of life', 'asthma control or quality of life']","[{'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0201931', 'cui_str': 'Carbon dioxide measurement, partial pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",24.0,0.0282954,"Moreover, ΔpCO2 (baseline - 18 weeks of follow up) was significantly correlated with ΔAQLQ (rs = 0.78,  p = 0.02 ).
","[{'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Eindhoven', 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Türk', 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van der Veer', 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oosterbaan-Beks', 'Affiliation': 'Speech Therapist, Haga ziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Goes-de Graaff', 'Affiliation': 'Speech Therapist, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Bendien', 'Affiliation': 'Department of Pulmonology, Haga ziekenhuis , Den Haag, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Kluijver', 'Affiliation': 'Department of Pulmonology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Arendse', 'Affiliation': 'Department of Ear, Nose and Throat Medicine (ENT), Ikazia Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hooft van Huysduynen', 'Affiliation': 'Department of Ear, Nose and Throat Medicine (ENT), Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'J C C M', 'Initials': 'JCCM', 'LastName': ""In 't Veen"", 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Braunstahl', 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1837156']
1591,31294630,Becoming adherent to a preventive treatment for HIV: a qualitative approach.,"The clinical trial ANRS-IPERGAY investigated the efficacy of sexual activity-based (i.e. on demand) HIV pre-exposure prophylaxis (PrEP). Using a qualitative method, we analysed the role of adherence as one of the main elements for PrEP effectiveness and its associated determinants. Data were collected in various French ANRS-IPERGAY sites during the double-blind (2012-2014) and open-label study (2015-2016) phases, through two individual interviews per participant, collective interviews and focus groups. A total of 83 participants participated in the present study. Our analysis included 32 individual interviews (with 16 participants), 13 collective interviews ( n  = 45) and 8 focus groups ( n  = 33). We investigated adherence to on-demand pill-intake schedule, focusing especially on PrEP integration into daily life. PrEP intake was regulated through coping strategies to simplify implementation and avoid stigmatizing reactions. We considered self-care and pharmaceuticalization of prevention as specific features of sexual activity-based PrEP. As PrEP is a prophylaxis for seronegative people, it is contributing to the emergence of a new identity in the HIV field. Health-care professionals should take into account the practical implementation of PrEP schedules into daily life, assist PrEP users in personal management of pill intake and, more generally, improve adherence to the prophylaxis.",2020,"Our analysis included 32 individual interviews (with 16 participants), 13 collective interviews ( n  = 45) and 8 focus groups ( n  = 33).","['83 participants participated in the present study', '32 individual interviews (with 16 participants), 13 collective interviews ( n  = 45) and 8 focus groups ( n  = 33']",[],[],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]",[],[],83.0,0.0261129,"Our analysis included 32 individual interviews (with 16 participants), 13 collective interviews ( n  = 45) and 8 focus groups ( n  = 33).","[{'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Puppo', 'Affiliation': 'GRePS, Lyon 2 University, Lyon, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mabire', 'Affiliation': 'GRePS, Lyon 2 University, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Morel', 'Affiliation': 'AIDES, Paris, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Laguette', 'Affiliation': 'CRPCO, Jules Verne University, Amiens, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rojas Castro', 'Affiliation': 'Coalition Plus, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chas', 'Affiliation': 'Hôpital Tenon, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pintado', 'Affiliation': ""Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Suzan-Monti', 'Affiliation': 'INSERM, IRD, SESSTIM, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': 'INSERM, IRD, SESSTIM, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hospital Saint-Louis, Department of Infectious Disease, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Préau', 'Affiliation': 'GRePS, Lyon 2 University, Lyon, France.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1640886']
1592,31297906,Therapist adherence to family-based treatment for adolescents with anorexia nervosa: A multi-site exploratory study.,"OBJECTIVE


This exploratory study is the first to examine family-based treatment (FBT) adherence and association to treatment outcome in the context of a large-scale, multi-centre study for the treatment of adolescents with anorexia nervosa.
METHOD


One hundred and ninety recorded FBT sessions from 68 adolescents with anorexia nervosa and their families were recruited across multiple sites (N = 6). Each site provided 1-4 tapes per family over four treatment time points, and each was independently rated for therapist adherence.
RESULTS


There were differences in adherence scores within and between sites. ANOVA produced a main effect for site, F(5, 46) = 8.6, p < .001, and phase, F(3, 42) = 12.7, p < .001, with adherence decreasing in later phases. Adherence was not associated to end of treatment percent ideal body weight after controlling for baseline percent ideal body weight (r = .088, p = .48).
CONCLUSIONS


Results suggest that FBT can be delivered with adherence in phase one of treatment. Adherence was not associated with treatment outcome as determined using percent ideal body weight.",2020,"ANOVA produced a main effect for site, F(5, 46) = 8.6, p < .001, and phase, F(3, 42) = 12.7, p < .001, with adherence decreasing in later phases.","['adolescents with anorexia nervosa', 'One hundred and ninety recorded FBT sessions from 68 adolescents with anorexia nervosa and their families were recruited across multiple sites']",['FBT'],"['adherence scores', 'Adherence', 'Therapist adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",190.0,0.0381741,"ANOVA produced a main effect for site, F(5, 46) = 8.6, p < .001, and phase, F(3, 42) = 12.7, p < .001, with adherence decreasing in later phases.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Dimitropoulos', 'Affiliation': 'Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'William Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Brandt', 'Affiliation': 'The Center for Eating Disorders, Sheppard Pratt Health System, Baltimore, MD.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Halmi', 'Affiliation': 'Department of Psychiatry, Weill Medical College, Cornell University, New York, NY.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Kaye', 'Affiliation': 'Centre for Eating Disorders, Department of Psychiatry, University of California, San Diego, CA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Pinhas', 'Affiliation': 'Ontario Shores Centre for Mental Health Sciences, Whitby, Ontario, Canada.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'D Blake', 'Initials': 'DB', 'LastName': 'Woodside', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2695']
1593,31320726,"An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA).","Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on health services. It is usually episodic and short-lived, so when a patient presents to their clinician, examination is normal. The CAVA (Continuous Ambulatory Vestibular Assessment) device has been developed to provide continuous monitoring of eye-movements, allowing insight into the physiological parameters present during a dizziness attack. This article describes the first clinical investigation into the medical and technical aspects of this new diagnostic system. Seventeen healthy subjects wore the device near continuously for up to thirty days, artificially inducing nystagmus on eight occasions. 405 days' worth of data was captured, comprising around four billion data points. A computer algorithm developed to detect nystagmus demonstrated a sensitivity of 99.1% (95% CI: 95.13% to 99.98%) and a specificity of 98.6% (95% CI: 96.54% to 99.63%). Eighty-two percent of participants wore the device for a minimum of eighty percent of each day. Adverse events were self-limiting and mostly the consequence of skin stripping from the daily replacement of the electrodes. The device was shown to operate effectively as an ambulatory monitor, allowing the reliable detection of artificially induced nystagmus.",2019,"The device was shown to operate effectively as an ambulatory monitor, allowing the reliable detection of artificially induced nystagmus.",['Seventeen healthy subjects'],['novel device for Continuous Ambulatory Vestibular Assessment (CAVA'],"['diagnostic accuracy, reliability, acceptability and safety', 'Dizziness']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521083', 'cui_str': 'Piper methysticum'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",17.0,0.0574124,"The device was shown to operate effectively as an ambulatory monitor, allowing the reliable detection of artificially induced nystagmus.","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Phillips', 'Affiliation': 'Norfolk and Norwich University Hospital, Department of Otolaryngology, Norwich, NR4 7UY, United Kingdom. john.phillips@mac.com.'}, {'ForeName': 'Jacob L', 'Initials': 'JL', 'LastName': 'Newman', 'Affiliation': 'University of East Anglia, School of Computing Sciences, Norwich, NR4 7TJ, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Cox', 'Affiliation': 'University of East Anglia, School of Computing Sciences, Norwich, NR4 7TJ, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-46970-7']
1594,31828878,What are the atrioventricular delays in right ventricular apical and septal pacing for optimal hemodynamics in patients with normal left ventricular function?,"INTRODUCTION


There is a surge of interest in alternate site pacing to prevent pacing-induced left ventricular dysfunction. However, little is known regarding the appropriate atrioventricular (AV) delay between right ventricular (RV) septal and RV apical pacing for optimal hemodynamic benefit.
OBJECTIVES


To determine the programmed values of atrial sensed and atrial paced AV delays in basal RV septal and apical RV pacing that results in the maximum delivered stroke volume (SV).
METHODS


We calculated the Doppler-derived SV at various sensed and paced AV delays in 50 patients with complete AV block implanted with a dual-chamber pacemaker (group A: 25 RV apical pacing; group B: 25 RV septal pacing). The hemodynamic difference in terms of the SV between sensed and paced AV delay, corresponding to the site of RV pacing was then compared for statistical significance.
RESULTS


In group A, maximal SV was derived at a sensed AV delay of 123.2 ± 11 ms and paced AV delay of 129.2 ± 10 ms, and in group B, at a sensed AV delay of 123.6 ± 8 ms and paced AV delay of and 132.8 ± 7 ms. At these intervals, there was no difference in the SV between septal and apical RV pacing (P = .28 and .22, respectively).
CONCLUSION


The atrial sensed and atrial paced AV delays for septal and apical RV pacing for optimal hemodynamics are similar. For optimal hemodynamics, the atrial paced AV delay is longer than the atrial sensed AV delay.",2020,"At these intervals, there was no difference in the SV between septal and apical RV pacing (P = .28 and .22, respectively).
","['50 patients with complete AV block implanted with a', 'patients with normal left ventricular function']",['dual-chamber pacemaker (group A: 25 RV apical pacing; group B: 25 RV septal pacing'],['SV between septal and apical RV pacing'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0442004', 'cui_str': 'Septal'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]",50.0,0.0257635,"At these intervals, there was no difference in the SV between septal and apical RV pacing (P = .28 and .22, respectively).
","[{'ForeName': 'Jayaprakash', 'Initials': 'J', 'LastName': 'Shenthar', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Bharatraj', 'Initials': 'B', 'LastName': 'Banavalikar', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Padmanabhan', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Mukund A', 'Initials': 'MA', 'LastName': 'Prabhu', 'Affiliation': 'Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14310']
1595,31933259,Resection of recurrent glioblastoma multiforme in elderly patients: a pseudo-randomized analysis revealed clinical benefit.,"INTRODUCTION


Elderly patients constitute an expanding part of our society. Due to a continuously increasing life expectancy, an optimal quality of life is expected even into advanced age. Glioblastoma (GBM) is more common in older patients, but they are still often withheld from efficient treatment due to worry of worse tolerance and have a significantly worse prognosis compared to younger patients. Our retrospective observational study aimed to investigate the therapeutic benefit from a second resection in recurrent glioblastoma of elderly patients.
MATERIALS AND METHODS


We included a cohort of 39 elderly patients (> 65 years) with a second resection as treatment option in the case of a tumor recurrence. A causal inference model was built by multiple non- and semiparametric models, which was used to identify matched patients from our elderly GBM database which comprises 538 patients. The matched cohorts were analyzed by a Cox-regression model adjusted by time-dependent covariates.
RESULTS


The Cox-regression analysis showed a significant survival benefit (Hazard Ratio: 0.6, 95% CI 0.36-0.9, p-value = 0.0427) for the re-resected group (18.0 months, 95% CI 13.97-23.2 months) compared to the group without re-resection (10.1 months, 95% CI 8.09-20.9 months). No differences in the co-morbidities or hemato-oncological side effects during chemotherapy could be detected. Anesthetic- and surgical complications were rare and comparable to the complication rate of patients undergoing the first-line resection.
CONCLUSION


Taken together, in elderly patients, re-resection is an acceptable treatment option in the recurrent state of a glioblastoma. The individual evaluation of the patients' medical status as well as the chances of withstanding general anesthesia needs to be done in close interdisciplinary consultation. If these requirements are met, elderly patients benefit from a re-resection.",2020,"The Cox-regression analysis showed a significant survival benefit (Hazard Ratio: 0.6, 95% CI 0.36-0.9, p-value = 0.0427) for the re-resected group (18.0 months, 95% CI 13.97-23.2 months) compared to the group without re-resection (10.1 months, 95% CI 8.09-20.9 months).","['elderly patients', 'We included a cohort of 39 elderly patients (>\u200965\xa0years) with a second resection as treatment option in the case of a tumor recurrence', 'older patients', 'recurrent glioblastoma of elderly patients', 'matched patients from our elderly GBM database which comprises 538 patients']",['Glioblastoma (GBM'],"['co-morbidities or hemato-oncological side effects', 'survival benefit', 'Anesthetic- and surgical complications', 'complication rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0017636', 'cui_str': 'Glioblastoma'}]","[{'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0300569,"The Cox-regression analysis showed a significant survival benefit (Hazard Ratio: 0.6, 95% CI 0.36-0.9, p-value = 0.0427) for the re-resected group (18.0 months, 95% CI 13.97-23.2 months) compared to the group without re-resection (10.1 months, 95% CI 8.09-20.9 months).","[{'ForeName': 'Mateo Tomas', 'Initials': 'MT', 'LastName': 'Fariña Nuñez', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany. mateo.farina@uniklinik-freiburg.de.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Franco', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Cipriani', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Neidert', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Behringer', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Mader', 'Affiliation': 'Department of Neuroradiology, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Delev', 'Affiliation': 'Department of Neurosurgery, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fung', 'Affiliation': 'Department of Neurosurgery, Medical Center, University of Freiburg, Breisacher Straße 64, 79106, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Department of Neurosurgery, Medical Center, University of Freiburg, Breisacher Straße 64, 79106, Freiburg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Sankowski', 'Affiliation': 'Institute of Neuropathology, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Nils Henrik', 'Initials': 'NH', 'LastName': 'Nicolay', 'Affiliation': 'Medical Faculty, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dieter Henrik', 'Initials': 'DH', 'LastName': 'Heiland', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Translational NeuroOncology Research Group, Medical Center, University of Freiburg, Freiburg, Germany.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03393-z']
1596,32023582,Fasting and Non-Fasting Triglycerides and Risk of Cardiovascular Events in Diabetic Patients Under Statin Therapy.,"BACKGROUND


Few data specifically investigate associations between fasting/non-fasting triglycerides (TG) and cardiovascular (CV) events under statin therapy among Japanese diabetic patients.Methods and Results:We recruited 4,988 participants with diabetes from the EMPATHY study. Median follow-up was 3 years. We evaluated associations between serum fasting/non-fasting TG and first CV events in Cox-regression hazard models adjusted by classical risk factors. CV events were defined as (1) major adverse cardiac events (MACE) including myocardial infarction, stroke, or cardiac death; and (2) CV diseases (CVD) including myocardial infarction, unstable angina, ischemic stroke, or large artery disease or peripheral arterial disease. Fasting as well as non-fasting TG were associated with MACE (adjusted hazard ratio [HR]: 1.017 per 10 mg/dL; 95% confidence interval [CI]: 1.000-1.037; P=0.046, adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.006-1.050; P=0.0091) and CVD (adjusted HR: 1.024 per 10 mg/dL; 95% CI: 1.011-1.038; P=4.4×10 -3 , adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.010-1.046; P=4.9×10 -3 ). Comparing the top quartile with the bottom quartile of non-fasting TG, adjusted HR significantly increased 5.18 (95% CI: 1.38-18.3, P=0.014) for MACE, and 2.40 (95% CI: 1.11-4.75, P=0.021) for CVD, while adjusted HR did not change when divided into quartile of fasting TG.
CONCLUSIONS


Non-fasting TG could be considered as a substitute for fasting TG as a risk stratification for future CV events among Japanese diabetic patients.",2020,"Fasting as well as non-fasting TG were associated with MACE (adjusted hazard ratio [HR]: 1.017 per 10 mg/dL; 95% confidence interval [CI]: 1.000-1.037; P=0.046, adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.006-1.050; P=0.0091) and CVD (adjusted HR: 1.024 per 10 mg/dL; 95% CI: 1.011-1.038; P=4.4×10 -3 , adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.010-1.046; P=4.9×10 -3 ).","['Diabetic Patients Under Statin Therapy', 'Japanese diabetic patients', '4,988 participants with diabetes from the EMPATHY study']",[],"['serum fasting/non-fasting TG and first CV events', 'Fasting and Non-Fasting Triglycerides and Risk of Cardiovascular Events', 'adverse cardiac events (MACE) including myocardial infarction, stroke, or cardiac death; and (2) CV diseases (CVD) including myocardial infarction, unstable angina, ischemic stroke, or large artery disease or peripheral arterial disease', 'CV events', 'fasting/non-fasting triglycerides (TG) and cardiovascular (CV) events']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]",4988.0,0.0476656,"Fasting as well as non-fasting TG were associated with MACE (adjusted hazard ratio [HR]: 1.017 per 10 mg/dL; 95% confidence interval [CI]: 1.000-1.037; P=0.046, adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.006-1.050; P=0.0091) and CVD (adjusted HR: 1.024 per 10 mg/dL; 95% CI: 1.011-1.038; P=4.4×10 -3 , adjusted HR: 1.028 per 10 mg/dL; 95% CI: 1.010-1.046; P=4.9×10 -3 ).","[{'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiology, Kanazawa University Graduate School of Medicine.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nomura', 'Affiliation': 'Department of Cardiology, Kanazawa University Graduate School of Medicine.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Innovative Clinical Research Center, Kanazawa University.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': 'Department of Cardiovascular Medicine, The University of Tokyo Graduate School of Medicine.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamagishi', 'Affiliation': 'Osaka University of Human Sciences.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takamura', 'Affiliation': 'Department of Cardiology, Kanazawa University Graduate School of Medicine.'}, {'ForeName': 'Masa-Aki', 'Initials': 'MA', 'LastName': 'Kawashiri', 'Affiliation': 'Department of Cardiology, Kanazawa University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0981']
1597,32044975,Should fractional flow reserve follow angiographic visual inspection to guide preventive percutaneous coronary intervention in ST-elevation myocardial infarction?,"AIMS


We aimed to quantify the effect of preventive percutaneous coronary intervention (PCI to non-infarct arteries) on cardiac death and non-fatal myocardial infarction (MI) in patients with ST-elevation myocardial infarction (STEMI) according to whether the decision to carry out preventive PCI was based on angiographic visual inspection (AVI alone) or AVI plus fractional flow reserve (FFR) if AVI showed significant stenosis (AVI plus FFR).
METHODS AND RESULTS


Randomized trials comparing preventive PCI with no preventive PCI in STEMI without shock were identified by a systematic literature search and categorized according to whether they used AVI alone or AVI plus FFR to select patients for preventive PCI. Random effects meta-analyses and tests of heterogeneity were used to compare the two categories in respect of cardiac death and MI as a combined outcome and individually. Eleven eligible trials were identified. For cardiac death and MI, the relative risk estimates for AVI alone vs. AVI plus FFR were 0.39 (0.25-0.61) and 0.85 (0.57-1.28), respectively (P = 0.01 for difference), for cardiac death, alone the estimates were 0.36 (0.19-0.71) and 0.79 (0.36-1.77), respectively (P = 0.15 for difference), and for MI alone, 0.41 (0.23-0.73) and 0.98 (0.62-1.56), respectively (P = 0.04 for difference).
CONCLUSION


In preventive PCI among STEMI patients, AVI alone achieves a ∼60% reduction in cardiac death and MI but selecting patients using FFR in AVI positive patients loses much of the benefit. Angiographic visual inspection is best used without FFR in this group of patients.",2020,"For cardiac death and MI, the relative risk estimates for AVI alone vs. AVI plus FFR were 0.39 (0.25-0.61) and 0.85 (0.57-1.28),",['patients with ST-elevation myocardial infarction (STEMI'],['preventive percutaneous coronary intervention (PCI to non-infarct arteries'],"['Angiographic visual inspection', 'cardiac death', 'angiographic visual inspection (AVI alone) or AVI plus fractional flow reserve (FFR', 'cardiac death and non-fatal myocardial infarction (MI', 'cardiac death and MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",,0.0511001,"For cardiac death and MI, the relative risk estimates for AVI alone vs. AVI plus FFR were 0.39 (0.25-0.61) and 0.85 (0.57-1.28),","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Wald', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London Charterhouse Square, London EC1M6BQ, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hadyanto', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London Charterhouse Square, London EC1M6BQ, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Bestwick', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London Charterhouse Square, London EC1M6BQ, UK.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcaa012']
1598,33105645,Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review.,"Three patients with multi-year histories of relapsing and remitting Lyme disease and associated co-infections despite extended antibiotic therapy were each given double-dose dapsone combination therapy (DDD CT) for a total of 7-8 weeks. At the completion of therapy, all three patients' major Lyme symptoms remained in remission for a period of 25-30 months. A retrospective chart review of 37 additional patients undergoing DDD CT therapy (40 patients in total) was also performed, which demonstrated tick-borne symptom improvements in 98% of patients, with 45% remaining in remission for 1 year or longer. In conclusion, double-dose dapsone therapy could represent a novel and effective anti-infective strategy in chronic Lyme disease/ post-treatment Lyme disease syndrome (PTLDS), especially in those individuals who have failed regular dose dapsone combination therapy (DDS CT) or standard antibiotic protocols. A randomized, blinded, placebo-controlled trial is warranted to evaluate the efficacy of DDD CT in those individuals with chronic Lyme disease/PTLDS.",2020,"At the completion of therapy, all three patients' major Lyme symptoms remained in remission for a period of 25-30 months.","['individuals with chronic Lyme disease/PTLDS', '37 additional patients undergoing DDD CT therapy (40 patients in total', 'Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections', 'Three patients with multi-year histories of relapsing and remitting Lyme disease and associated co-infections despite extended antibiotic therapy', 'individuals who have failed regular dose dapsone combination therapy (DDS CT) or standard antibiotic protocols']","['placebo', 'dapsone combination therapy (DDD CT', 'Double-Dose Dapsone Combination Therapy', 'DDD CT']",['major Lyme symptoms'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2063079', 'cui_str': 'Chronic Lyme Disease'}, {'cui': 'C3890422', 'cui_str': 'Post treatment Lyme disease syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0524058,"At the completion of therapy, all three patients' major Lyme symptoms remained in remission for a period of 25-30 months.","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'Member, HHS Babesia and Tick-borne Pathogens Subcommittee, Washington, DC 20201, USA.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, Hyde Park, NY 12538, USA.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9110725']
1599,33105701,Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study.,"Individuals with type 2 diabetes (T2D) require a long-term dietary strategy for blood glucose management and may benefit from time-restricted eating (TRE, where the duration between the first and last energy intake is restricted to 8-10 h/day). We aimed to determine the feasibility of TRE for individuals with T2D. Participants with T2D (HbA1c >6.5 to <9%, eating window >12 h/day) were recruited to a pre-post, non-randomised intervention consisting of a 2-week Habitual period to establish baseline dietary intake, followed by a 4-weeks TRE intervention during which they were instructed to limit all eating occasions to between 10:00 and 19:00 h on as many days of each week as possible. Recruitment, retention, acceptability, and safety were recorded throughout the study as indicators of feasibility. Dietary intake, glycaemic control, psychological well-being, acceptability, cognitive outcomes, and physiological measures were explored as secondary outcomes. From 594 interested persons, and 27 eligible individuals, 24 participants enrolled and 19 participants (mean ± SD; age: 50 ± 9 years, BMI: 34 ± 5 kg/m 2 , HbA1c: 7.6 ± 1.1%) completed the 6-week study. Overall daily dietary intake did not change between Habitual (~8400 kJ/d; 35% carbohydrate, 20% protein, 41% fat, 1% alcohol) and TRE periods (~8500 kJ/d; 35% carbohydrate, 19% protein, 42% fat, 1% alcohol). Compliance to the 9 h TRE period was 72 ± 24% of 28 days (i.e., ~5 days/week), with varied adherence (range: 4-100%). Comparisons of adherent vs. non-adherent TRE days showed that adherence to the 9-h TRE window reduced daily energy intake through lower absolute carbohydrate and alcohol intakes. Overall, TRE did not significantly improve measures of glycaemic control (HbA1c -0.2 ± 0.4%;  p  = 0.053) or reduce body mass. TRE did not impair or improve psychological well-being, with variable effects on cognitive function. Participants described hunger, daily stressors, and emotions as the main barriers to adherence. We demonstrate that 4-weeks of TRE is feasible and achievable for these individuals with T2D to adhere to for at least 5 days/week. The degree of adherence to TRE strongly influenced daily energy intake. Future trials may benefit from supporting participants to incorporate TRE in regular daily life and to overcome barriers to adherence.",2020,"Overall, TRE did not significantly improve measures of glycaemic control (HbA1c -0.2 ± 0.4%;  p  = 0.053) or reduce body mass.","['Individuals with Type 2 Diabetes', 'individuals with T2D. Participants with T2D (HbA1c >6.5 to <9%, eating window >12 h/day', 'Individuals with type 2 diabetes (T2D', 'From 594 interested persons, and 27 eligible individuals, 24 participants enrolled and 19 participants (mean ± SD; age: 50 ± 9 years, BMI: 34 ± 5 kg/m 2 , HbA1c: 7.6 ± 1.1%) completed the 6-week study']","['TRE', '2-week Habitual period to establish baseline dietary intake, followed by a 4-weeks TRE intervention']","['Recruitment, retention, acceptability, and safety', 'Overall daily dietary intake', 'cognitive function', 'Dietary intake, glycaemic control, psychological well-being, acceptability, cognitive outcomes, and physiological measures', 'hunger, daily stressors, and emotions as the main barriers to adherence', 'glycaemic control']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",24.0,0.0792208,"Overall, TRE did not significantly improve measures of glycaemic control (HbA1c -0.2 ± 0.4%;  p  = 0.053) or reduce body mass.","[{'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, 215 Spring Street, Victoria 3000, Australia.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, La Trobe University, Plenty Road and Kingsbury Drive, Bundoora, Victoria 3086, Australia.'}, {'ForeName': 'Karen H C', 'Initials': 'KHC', 'LastName': 'Lim', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, 215 Spring Street, Victoria 3000, Australia.'}, {'ForeName': 'Laura N Z', 'Initials': 'LNZ', 'LastName': 'Moresi', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Locked Bag 4115, Fitzroy, Victoria Melbourne 3065, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Geils', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Locked Bag 4115, Fitzroy, Victoria Melbourne 3065, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Brennan', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Locked Bag 4115, Fitzroy, Victoria Melbourne 3065, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, 215 Spring Street, Victoria 3000, Australia.'}]",Nutrients,['10.3390/nu12113228']
1600,33105799,Effects of Acute Aerobic Exercise Combined with Resistance Exercise on Neurocognitive Performance in Obese Women.,"To the best of the author's knowledge, there have been no previous studies conducted on the effects of a combination of acute aerobic and resistance exercise on deficit of inhibitory control in obese individuals. The aim of this study was, thus, to examine the effect of a single bout of such an exercise mode on behavioral and cognitive electrophysiological performance involving cognitive interference inhibition in obese women. After the estimated VO 2 max and percentage fat (measured with dual-energy X-ray absorptiometry (Hologic, Bedford, MA, USA) were assessed, 32 sedentary obese female adults were randomly assigned to an exercise group (EG) and a control group (CG), with their behavioral performance being recorded with concomitant electrophysiological signals when performing a Stroop task. Then, the EG engaged in 30 min of moderate-intensity aerobic exercise combined with resistance exercise, and the CG rested for a similar duration of time without engaging in any type of exercise. After the interventions, the neurocognitive performance was measured again in the two groups. The results revealed that although acute exercise did not enhance the behavioral indices (e.g., accuracy rates (ARs) and reaction times (RTs)), cognitive electrophysiological signals were improved (e.g., shorter N2 and P3 latencies, smaller N2 amplitudes, and greater P3 amplitudes) in the Stroop task after the exercise intervention in the EG. The findings indicated that a combination of acute moderate-intensity aerobic and resistance exercise may improve the neurophysiological inhibitory control performance of obese women.",2020,"The results revealed that although acute exercise did not enhance the behavioral indices (e.g., accuracy rates (ARs) and reaction times (RTs)), cognitive electrophysiological signals were improved (e.g., shorter N2 and P3 latencies, smaller N2 amplitudes, and greater P3 amplitudes) in the Stroop task after the exercise intervention in the EG.","['obese women', 'Obese Women', 'obese individuals', '32 sedentary obese female adults']","['moderate-intensity aerobic exercise combined with resistance exercise', 'exercise group (EG) and a control group (CG), with their behavioral performance being recorded with concomitant electrophysiological signals when performing a Stroop task', 'Acute Aerobic Exercise Combined with Resistance Exercise', 'acute aerobic and resistance exercise']","['neurophysiological inhibitory control performance', 'shorter N2 and P3 latencies, smaller N2 amplitudes, and greater P3 amplitudes', 'Neurocognitive Performance', 'neurocognitive performance', 'behavioral indices (e.g., accuracy rates (ARs) and reaction times (RTs)), cognitive electrophysiological signals']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",32.0,0.0640802,"The results revealed that although acute exercise did not enhance the behavioral indices (e.g., accuracy rates (ARs) and reaction times (RTs)), cognitive electrophysiological signals were improved (e.g., shorter N2 and P3 latencies, smaller N2 amplitudes, and greater P3 amplitudes) in the Stroop task after the exercise intervention in the EG.","[{'ForeName': 'Huei-Jhen', 'Initials': 'HJ', 'LastName': 'Wen', 'Affiliation': 'Physical Education Center, College of Education and Communication, Tzu Chi University, Hualien 97004, Taiwan.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institution of Physical Education, Health and Leisure Studies, National Cheng Kung University, Tainan 70101, Taiwan.'}]",Brain sciences,['10.3390/brainsci10110767']
1601,33105819,Combination Therapy of High-Dose Rabeprazole Plus Metronomic Capecitabine in Advanced Gastro-Intestinal Cancer: A Randomized Phase II Trial.,"BACKGROUND


In recent years, proton pump inhibitors (PPIs) have been investigated at high-dose to modulate tumor microenvironment acidification thus restoring chemotherapeutic sensitivity. This is the first trial to study activity and safety of repurposing high dose rabeprazole combined with metronomic capecitabine (mCAP).
METHODS


A phase II study in which patients with gastrointestinal cancer, refractory to standard treatments, who had a life expectancy >3 months, were blind randomized 1:1 to mCAP, 1500 mg/daily, continuously with or without rabeprazole 1.5 mg/kg bid, three days a week. The primary endpoint was 3-months progression-free survival (PFS). The secondary endpoints were clinical benefit (CB) and overall survival (OS). Safety and plasma concentrations of capecitabine and its metabolites (5'-DFUR and 5-FU) were also evaluated.
RESULTS


Sixty-seven (median age 69 years; 63% male; 84% colorectal cancer, 76% ECOG-PS ≤ 1; 84% pretreated with two or more lines of chemotherapy) out of 90 patients screened for eligibility, were randomized to receive mCAP+rabeprazole ( n  = 32) vs. mCAP ( n  = 35). All patients were evaluable for response. No significant difference between mCAP+rabeprazole vs. mCAP, in terms of 3-months PFS rate (HR = 1.43, 95%CI 0.53-3.85;  p  = 0.477), median PFS (HR = 1.22, 95%CI 0.75-2.00,  p  = 0.420), CB (RR = 0.85, 95%CI 0.29-2.44;  p  = 0.786) and median OS (HR = 0.89, 95%CI 0.54-1.48;  p  = 0.664) was observed. However, a 3-year OS rate of 10% and 12% was reported in the mCAP-rabeprazole and mCAP groups, respectively. Overall, no grade 3 or 4 toxicity occurred but grade 1 or 2 adverse event of any type were more frequently in the mCAP+rabeprazole group than in the mCAP (OR 2.83, 95%CI 1.03-7.79;  p  = 0.043). Finally, there was not statistically significant difference in the plasma concentration of capecitabine and its metabolites between the two groups.
CONCLUSIONS


Although the adjunct of high dose rabeprazole to mCAP was not shown to affect mCAP activity, as PPI are being investigated worldwide as drugs to be repositioned in cancer treatment and also considering the limited sample size as well as the favorable safety profile of the combination in the present study, further clinical investigations are desirable.",2020,"No significant difference between mCAP+rabeprazole vs. mCAP, in terms of 3-months PFS rate (HR = 1.43, 95%CI 0.53-3.85;  p  = 0.477), median PFS (HR = 1.22, 95%CI 0.75-2.00,  p  = 0.420), CB (RR = 0.85, 95%CI 0.29-2.44;  p  = 0.786) and median OS (HR = 0.89, 95%CI 0.54-1.48;  p  = 0.664) was observed.","['Sixty-seven (median age 69 years; 63% male; 84% colorectal cancer, 76% ECOG-PS ≤ 1', 'patients with gastrointestinal cancer, refractory to standard treatments, who had a life expectancy >3 months', '90 patients screened for eligibility', 'Advanced Gastro-Intestinal Cancer']","['rabeprazole combined with metronomic capecitabine (mCAP', 'Rabeprazole Plus Metronomic Capecitabine', 'mCAP+rabeprazole', 'proton pump inhibitors (PPIs', 'mCAP-rabeprazole', 'mCAP+rabeprazole vs. mCAP', 'rabeprazole', 'mCAP']","['3-year OS rate', '3-months PFS rate', ""Safety and plasma concentrations of capecitabine and its metabolites (5'-DFUR and 5-FU"", '3-months progression-free survival (PFS', 'grade 3 or 4 toxicity', 'clinical benefit (CB) and overall survival (OS', 'median OS', 'plasma concentration of capecitabine and its metabolites', 'median PFS']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0048808', 'cui_str': 'doxifluridine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.242312,"No significant difference between mCAP+rabeprazole vs. mCAP, in terms of 3-months PFS rate (HR = 1.43, 95%CI 0.53-3.85;  p  = 0.477), median PFS (HR = 1.22, 95%CI 0.75-2.00,  p  = 0.420), CB (RR = 0.85, 95%CI 0.29-2.44;  p  = 0.786) and median OS (HR = 0.89, 95%CI 0.54-1.48;  p  = 0.664) was observed.","[{'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Roberto', 'Affiliation': 'Department of Clinical and Molecular Medicine, University ""La Sapienza"", 00189 Roma, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Romiti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University ""La Sapienza"", 00189 Roma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Mazzuca', 'Affiliation': 'Department of Clinical and Molecular Medicine, University ""La Sapienza"", 00189 Roma, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Milano', 'Affiliation': ""Oncology Unit, Sant' Andrea University Hospital, 00189 Roma, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""D'Antonio"", 'Affiliation': ""Oncology Unit, Sant' Andrea University Hospital, 00189 Roma, Italy.""}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Lionetto', 'Affiliation': ""Mass Spectrometry Lab-Clinical Biochemistry Unit, Sant'Andrea University Hospital, 00189 Rome, Italy.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational and Precision medicine, University ""La Sapienza"", viale dell\'Università 37, 00185 Rome, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Strigari', 'Affiliation': 'Department of Medical physics, Policlinico S.Orsola Malpighi, 40138 Bologna, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Simmaco', 'Affiliation': 'Department of Neurosciences, Mental Health and Sensory Organs, University ""La Sapienza"", via di Grottarossa 1035, 00189 Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fais', 'Affiliation': 'Department of Oncology and Molecular Medicine, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University ""La Sapienza"", 00189 Roma, Italy.'}]",Cancers,['10.3390/cancers12113084']
1602,33105861,Efficacy and Safety of Kudzu Flower-Mandarin Peel on Hot Flashes and Bone Markers in Women during the Menopausal Transition: A Randomized Controlled Trial.,"This randomized controlled study aimed to assess the efficacy and safety of an extract mixture of kudzu flower and mandarin peel (KM) on hot flashes (HFs) and markers of bone turnover in women during the menopausal transition. Healthy women aged 45-60 years with the menopausal HFs were randomly assigned in a 1:1 ratio to either KM (1150 mg/day) or placebo arms for 12 weeks (n = 84). The intent-to-treat analysis found that compared with the placebo, the KM significantly attenuated HF scores ( p  = 0.041) and HF severities ( p  < 0.001), with a mean difference from baseline to week 12. The KM also improved bone turnover markers, showing a significant reduction in bone resorption CTx ( p  = 0.027) and a tendency of increasing bone formation OC relative to the placebo. No serious adverse events and hormonal changes were observed in both groups. These findings suggest that KM consumption may improve the quality of life in ways that are important to symptomatic menopausal women.",2020,"The KM also improved bone turnover markers, showing a significant reduction in bone resorption CTx ( p  = 0.027) and a tendency of increasing bone formation OC relative to the placebo.","['symptomatic menopausal women', 'Healthy women aged 45-60 years with the menopausal HFs', 'Women during the Menopausal Transition', 'women during the menopausal transition']","['extract mixture of kudzu flower and mandarin peel (KM', 'Kudzu Flower-Mandarin Peel', 'placebo', 'KM']","['HF severities', 'serious adverse events and hormonal changes', 'efficacy and safety', 'hot flashes (HFs) and markers of bone turnover', 'HF scores', 'Hot Flashes and Bone Markers', 'bone turnover markers', 'bone formation OC', 'bone resorption CTx', 'quality of life']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0950069', 'cui_str': 'Kudzu'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.263264,"The KM also improved bone turnover markers, showing a significant reduction in bone resorption CTx ( p  = 0.027) and a tendency of increasing bone formation OC relative to the placebo.","[{'ForeName': 'Ji Eon', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Hyeyun', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Soohee', 'Initials': 'S', 'LastName': 'Hur', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Junho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'LG Household and Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}]",Nutrients,['10.3390/nu12113237']
1603,33105885,A Randomized Clinical Trial to Evaluate the Effect of Canephron N in Comparison to Ciprofloxacin in the Prevention of Postoperative Lower Urinary Tract Infections after Midurethral Sling Surgery.,"Urinary tract infections (UTIs) are one of the most common reasons for antibiotic prescriptions among women worldwide. UTIs are also associated with intra- and postoperative catheterization, which is an essential component of many gynecological surgical procedures, including midurethral sling (MUS) placement. The aim of this study was to compare the incidence of UTI subsequent to a MUS procedure. The study involved 562 female patients who underwent MUS procedures due to stress urinary incontinence (SUI). Patients were assigned in a 1:1 ratio to two study groups: patients receiving 500 mg of ciprofloxacin three times a day for 3 consecutive days after surgery or patients receiving 5 mL of Canephron taken orally three times a day for 3 weeks. After analyzing the collected data, it was found that in the group of patients receiving ciprofloxacin, 29 women (10.98%) had a UTI, whereas in the group of patients receiving Canephron, 36 women (13.64%) had a UTI within 6 months after the patient's MUS procedure. No statistically significant difference between the two groups was noted. Postoperative prophylaxis with a phytodrug can be perceived as an attractive option in the reduction of antibiotic consumption among female patients after a MUS procedure.",2020,No statistically significant difference between the two groups was noted.,"['Postoperative Lower Urinary Tract Infections after Midurethral Sling Surgery', '562 female patients who underwent MUS procedures due to stress urinary incontinence (SUI', 'female patients after a MUS procedure']","['ciprofloxacin', 'Ciprofloxacin', 'Canephron N', 'Canephron']",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0268821', 'cui_str': 'Lower urinary tract infectious disease'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0054586', 'cui_str': 'canephron N'}]",[],562.0,0.0484273,No statistically significant difference between the two groups was noted.,"[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Rechberger', 'Affiliation': '2nd Department of Gynecology, Medical Faculty, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': '2nd Department of Gynecology, Medical Faculty, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wawrysiuk', 'Affiliation': '2nd Department of Gynecology, Medical Faculty, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Miotla', 'Affiliation': '2nd Department of Gynecology, Medical Faculty, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Kulik-Rechberger', 'Affiliation': 'Department of Paediatric Propedeutics, Medical Faculty, Medical University of Lublin, ul. A. Gebali 9, 20-091 Lublin, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kuszka', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical Faculty, Am Krankenhaus 5, 24211 Preetz, Germany.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Wróbel', 'Affiliation': '2nd Department of Gynecology, Medical Faculty, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9113391']
1604,33105889,Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes.,"Approximately 20% of people will experience a depressive episode by adulthood, making adolescence an important developmental target for prevention. CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral, Humanistic, and Interpersonal Training), an online depression prevention intervention, has demonstrated efficacy in preventing depressive episodes among adolescents reporting elevated symptoms. Our study examines the effects of CATCH-IT compared to online health education (HE) on internalizing symptoms in adolescents at risk for depression. Participants, ages 13-18, were recruited across eight US health systems and were randomly assigned to CATCH-IT or HE. Assessments were completed at baseline, 2, 6, 12, 18, and 24 months. There were no significant differences between groups in change in depressive symptoms (b = -0.31 for CATCH-IT, b = -0.27 for HE,  p  = 0.80) or anxiety (b = -0.13 for CATCH-IT, b = -0.11 for HE,  p  = 0.79). Improvement in depressive symptoms was statistically significant ( p  < 0.05) for both groups ( p  = 0.004 for CATCH-IT,  p  = 0.009 for HE); improvement in anxiety was significant for CATCH-IT ( p  = 0.04) but not HE ( p  = 0.07). Parental depression and positive relationships with primary care physicians (PRPC) moderated the anxiety findings, and adolescents' externalizing symptoms and PRPC moderated the depression findings. This study demonstrates the long-term positive effects of both online programs on depressive symptoms and suggests that CATCH-IT demonstrates cross-over effects for anxiety as well.",2020,"Improvement in depressive symptoms was statistically significant ( p  < 0.05) for both groups ( p  = 0.004 for CATCH-IT,  ","['Participants, ages 13-18, were recruited across eight US health systems', 'Primary Care', 'adolescents at risk for depression']","['CATCH-IT or HE', 'Internet-Based Adolescent Depression Prevention Intervention', 'online health education (HE', 'CATCH-IT']","['anxiety', 'depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0553977,"Improvement in depressive symptoms was statistically significant ( p  < 0.05) for both groups ( p  = 0.004 for CATCH-IT,  ","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Gladstone', 'Affiliation': 'The Robert S. and Grace W. Stone Primary Prevention Initiatives, Wellesley Centers for Women, Wellesley College, Wellesley, MA 02481, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Buchholz', 'Affiliation': 'The Robert S. and Grace W. Stone Primary Prevention Initiatives, Wellesley Centers for Women, Wellesley College, Wellesley, MA 02481, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Department of General Pediatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Miae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of General Pediatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Benjamin W Van', 'Initials': 'BWV', 'LastName': 'Voorhees', 'Affiliation': 'Department of General Pediatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17217736']
1605,33105928,"[Evaluation of drug-drug interactions between yimitasvir phosphate capsules with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets].","Objective:  To evaluate the drug-drug interactions and the tolerability of combined medication between yimitasvir phosphate capsules with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets in healthy volunteers.  Methods:  A randomized, open, and continuous administration design was used in trial 1 (yimitasvir phosphate capsules with sofosbuvir tablets). 28 subjects were randomly divided into two groups. A non-randomized, open design was used in trial 2 (yimitasvir phosphate capsules with omeprazole magnesium enteric-coated tablets), and included 42 subjects divided into three groups. The open design method was used in trial 3 (yimitasvir phosphate capsules with rosuvastatin calcium tablets), and included 14 subjects. The plasma concentrations of yimitasvir phosphate, sofosbuvir and their main metabolites GS-331007, omeprazole and rosuvastatin were validated by a liquid chromatography/tandem mass spectrometry (LC-MS/MS). The pharmacokinetic parameters were calculated by Phoenix winNonlin software.  Results:  (1) in trial 1, after single and co-administration, the 90%  CI  of sofosbuvir C(max) and AUC(0-tau) geometric mean ratio (GMR) were 152.0% (118.0% ~ 197.0%) and 230.0% (184.0% ~ 287.0%), with an increase of 52.0% and 130.0% compared to single dose of sofosbuvir, respectively. The 90%  CI  of GS-331007 C(max) GMR was 74.0% (67.5% ~ 81.2%) and reduced by 26% compared to single dose of sofosbuvir. (2) in trial 2, the 90%  CI  of C(max) GMR after yimitasvir single or co-administration at the same time, with a 4-hours interval, or with a 12- hours interval were 68.9% (44.5% ~ 106.7%) , 64.0% (43.8% ~ 93.6%) and 56.4%(38.9% ~ 81.9%), and the 90%  CI  of AUC(0-t) GMR were 68.6% (46.5% ~ 101.2%), 68.3% (47.6% ~ 98.0%) and 60.5% (41.8% ~ 87.5%), respectively. Compared with single dose of yimitasvir, the C(max) and AUC(0-t) were decreased by 31.1% and 31.4%, 36.0% and 31.7%, 43.6% and 39.5%, respectively. (3) In trial 3, after single and co-administration, the 90%  CI  of rosuvastatin C(max) and AUC(0-72) GMR were 172.4% (153.6% ~ 193.5%) and 158.0% (144.3% ~ 172.9%), respectively, with an increase of 74.9% and 60.5% compared to single dose of rosuvastatin. There were no serious adverse events and adverse events leading to withdrawal from the trial.  Conclusion:  Yimitasvir phosphate capsules have drug-drug interactions with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets.",2020,"CI  of rosuvastatin C(max) and AUC(0-72) GMR were 172.4% (153.6% ~ 193.5%) and 158.0% (144.3% ~ 172.9%), respectively, with an increase of 74.9% and 60.5% compared to single dose of rosuvastatin.","['28 subjects', 'healthy volunteers', '42 subjects divided into three groups', '14 subjects']","['3 (yimitasvir phosphate capsules with rosuvastatin calcium tablets', 'omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets', 'C(max', 'omeprazole magnesium enteric-coated tablets', 'rosuvastatin', 'yimitasvir phosphate capsules with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets']","['AUC(0-t) GMR', 'sofosbuvir C(max) and AUC(0-tau) geometric mean ratio (GMR', 'plasma concentrations of yimitasvir phosphate, sofosbuvir and their main metabolites GS-331007, omeprazole and rosuvastatin', 'GS-331007 C(max) GMR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4742120', 'cui_str': 'yimitasvir phosphate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1098080', 'cui_str': 'Crestor'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0771765', 'cui_str': 'Omeprazole magnesium'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C3696702', 'cui_str': 'sofosbuvir Oral Tablet'}]","[{'cui': 'C1522544', 'cui_str': 'CSF2RA protein, human'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4742120', 'cui_str': 'yimitasvir phosphate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]",28.0,0.03366,"CI  of rosuvastatin C(max) and AUC(0-72) GMR were 172.4% (153.6% ~ 193.5%) and 158.0% (144.3% ~ 172.9%), respectively, with an increase of 74.9% and 60.5% compared to single dose of rosuvastatin.","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Mai', 'Affiliation': 'Phase I Clinical Trials Unit of the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trials Unit of the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Peng', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Xie', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Hec Technology Holding CO.,Ltd., State Key Laboratory of Anti-infective Drug Development No.2015DQ780357, Guangzhou 510000, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trials Unit of the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trials Unit of the First Hospital of Jilin University, Changchun 130021, China.'}]",Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology,['10.3760/cma.j.cn501113-20200907-00503']
1606,33105962,[Comparison of percutaneous pedicle screw placement under O-arm navigation with traditional percutaneous pedicle screw placement in patients with thoracolumbar fractures without neurological symptoms].,"Objective:  To investigate the accuracy and clinical efficacy of percutaneous pedicle screw placement under O-arm navigation and traditional fluoroscopy in patients with thoracolumbar fractures without neurological symptoms.  Methods:  From July 2016 to July 2018, 72 patients with thoracolumbar fractures in Peking University International Hospital without neurological symptoms were divided into two groups, group A and group B. In group A, 36 patients underwent the surgery of percutaneous pedicle screw implantation under traditional fluoroscopy and 168 pedicle screws were inserted. In group B, 36 patients underwent the surgery of percutaneous pedicle screw implantation under O-arm guided fluoroscopy and 164 pedicle screws were inserted by the same surgeon. The general condition, operation condition, radiation dose, fluoroscopy time of single screw, screw placement time and accuracy, visual analogue score (VAS) score, Oswestry dysfunction index (ODI), kyphosis Cobb's angle, anterior edge height of 1 week and 6 months after surgery were compared. The data were compared with paired  t  test between the two groups.  Results:  There was no significant differences between the two groups in general condition, intraoperative blood loss, length of hospital stay, VAS, ODI, kyphosis Cobb's angle, and anterior edge height of the injured vertebra (all  P> 0.05). The operation time was (99±14) min in group A and (75±10) min in group B, the average screw setting time was (15.8±2.6) min in group A and (11.8±3.3) min in group B, the fluoroscopy time of each screw was (38.0±2.0) s in group A and (28.5±2.8) s in group B, the radiation dose of each surgery was (563±163) cGy/cm(2) in group A and (378±70) cGy/cm(2) in group B; the above-mentioned data of group A were all superior to those in group B and the differences between the two groups were all statistically significant ( t= 8.48, 5.73, 16.30, 6.25, all  P< 0.05). Rampersaud grading in group A was better than group B, and the differences between the two groups was statistically significant(χ(2)=12.2,  P< 0.05).  Conclusion:  The O-arm navigation system could not only provide high-definition navigation images and achieve high-precision navigation operations, which is more accurate than traditional pedicle screws placement, but also contribute to the reconstruction of spinal stability and reduce radiation dose, pedicle screws placement and operating time.",2020,"There was no significant differences between the two groups in general condition, intraoperative blood loss, length of hospital stay, VAS, ODI, kyphosis Cobb's angle, and anterior edge height of the injured vertebra (all  P> 0.05).","['patients with thoracolumbar fractures without neurological symptoms', '36 patients underwent the surgery of', 'July 2016 to July 2018, 72 patients with thoracolumbar fractures in Peking University International Hospital without neurological symptoms']","['percutaneous pedicle screw placement under O-arm navigation with traditional percutaneous pedicle screw placement', 'percutaneous pedicle screw placement under O-arm navigation and traditional fluoroscopy', 'percutaneous pedicle screw implantation under traditional fluoroscopy', 'percutaneous pedicle screw implantation under O-arm guided fluoroscopy']","['average screw setting time', 'fluoroscopy time of each screw', ""general condition, intraoperative blood loss, length of hospital stay, VAS, ODI, kyphosis Cobb's angle, and anterior edge height of the injured vertebra"", ""general condition, operation condition, radiation dose, fluoroscopy time of single screw, screw placement time and accuracy, visual analogue score (VAS) score, Oswestry dysfunction index (ODI), kyphosis Cobb's angle, anterior edge height of 1 week and 6 months after surgery"", 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",72.0,0.0219408,"There was no significant differences between the two groups in general condition, intraoperative blood loss, length of hospital stay, VAS, ODI, kyphosis Cobb's angle, and anterior edge height of the injured vertebra (all  P> 0.05).","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Ge', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopedics, Peking University International Hospital, Beijing 102206, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200311-00705']
1607,32868437,Fine-scale heterogeneity in  Schistosoma mansoni  force of infection measured through antibody response.,"Schistosomiasis is among the most common parasitic diseases in the world, with over 142 million people infected in low- and middle-income countries. Measuring population-level transmission is centrally important in guiding schistosomiasis control programs. Traditionally, human  Schistosoma mansoni  infections have been detected using stool microscopy, which is logistically difficult at program scale and has low sensitivity when people have low infection burdens. We compared serological measures of transmission based on antibody response to  S. mansoni  soluble egg antigen (SEA) with stool-based measures of infection among 3,663 preschool-age children in an area endemic for  S. mansoni  in western Kenya. We estimated force of infection among children using the seroconversion rate and examined how it varied geographically and by age. At the community level, serological measures of transmission aligned with stool-based measures of infection (ρ = 0.94), and serological measures provided more resolution for between-community differences at lower levels of infection. Force of infection showed a clear gradient of transmission with distance from Lake Victoria, with 94% of infections and 93% of seropositive children in communities <1.5 km from the lake. Force of infection increased through age 3 y, by which time 65% (95% CI: 53%, 75%) of children were SEA positive in high-transmission communities-2 y before they would be reached by school-based deworming programs. Our results show that serologic surveillance platforms represent an important opportunity to guide and monitor schistosomiasis control programs, and that in high-transmission settings preschool-age children represent a key population missed by school-based deworming programs.",2020,"At the community level, serological measures of transmission aligned with stool-based measures of infection (ρ = 0.94), and serological measures provided more resolution for between-community differences at lower levels of infection.","['3,663 preschool-age children in an area endemic for  S. mansoni  in western Kenya']",[],['Force of infection'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]",[],"[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",3663.0,0.0262161,"At the community level, serological measures of transmission aligned with stool-based measures of infection (ρ = 0.94), and serological measures provided more resolution for between-community differences at lower levels of infection.","[{'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA 94143; ben.arnold@ucsf.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Kanyi', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Fredrick O', 'Initials': 'FO', 'LastName': 'Rawago', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Priest', 'Affiliation': 'Division of Foodborne, Waterborne and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333.'}, {'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA 30333.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lammie', 'Affiliation': 'Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur, GA 30030.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Won', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA 30333.'}, {'ForeName': 'Maurice R', 'Initials': 'MR', 'LastName': 'Odiere', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2008951117']
1608,32886666,Agents of change: Comparing HIV-related risk behavior of people attending ART clinics in Dar es Salaam with members of their social networks.,"The aim of the study is to compare sociodemographic characteristics, psychosocial factors, HIV knowledge and risk behaviors of people living with HIV (PLH) and their social network members (NMs) to inform HIV prevention programs that engage PLH as prevention educators in their communities. We compared baseline characteristics of PLH enrolled in an intervention to become HIV prevention Change Agents (CAs) (n = 458) and 602 NMs they recruited. CAs and NMs responded to questionnaires through a computer-driven interface with Audio Computer-Assisted Self Interview (ACASI) software. Although NMs scored higher on socio-economic status, self-esteem and general self-efficacy, they had lower HIV knowledge (AOR 1.5; 95% CI: 1.1-2.1), greater inconsistent condom use (AOR 3.2; 95% CI: 2.4-4.9), and recent experience as perpetrators of physical (AOR 2.5; 95% CI: 1.2-5.1) or sexual (AOR 4.1; 95% CI: 1.4-12.7) intimate partner violence; and as victims of physical (AOR 1.5; 95% CI: 1.0-2.3) or sexual (AOR 2.2; 95% CI: 1.3-3.8) forms of violence than CAs. Higher HIV knowledge and lower sexual risk behaviors among CAs suggest PLH's potential as communicators of HIV prevention information to NMs. CAs' training should also focus on improving self-esteem, general self-efficacy and social support to increase their potential effectiveness as HIV prevention educators and enhance their own overall health and well-being.",2020,Higher HIV knowledge and lower sexual risk behaviors among CAs suggest PLH's potential as communicators of HIV prevention information to NMs.,"['people attending ART clinics in Dar es Salaam with members of their social networks', 'people living with HIV (PLH) and their social network members (NMs', 'change', 'PLH enrolled in an intervention to become HIV prevention Change Agents (CAs) (n = 458) and 602 NMs they recruited']",[],"['Higher HIV knowledge and lower sexual risk behaviors', 'HIV knowledge', 'socio-economic status, self-esteem and general self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C5191377', 'cui_str': '458'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0278699,Higher HIV knowledge and lower sexual risk behaviors among CAs suggest PLH's potential as communicators of HIV prevention information to NMs.,"[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Kaaya', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Siril', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Namweza Center, United Kingdom and Sweden.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Ainebyona', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Magreat', 'Initials': 'M', 'LastName': 'Somba', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Elspeth', 'Initials': 'E', 'LastName': 'McAdam', 'Affiliation': 'Namweza Center, United Kingdom and Sweden.'}, {'ForeName': 'Kicki', 'Initials': 'K', 'LastName': 'Oljemark', 'Affiliation': 'Namweza Center, United Kingdom and Sweden.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, Mwanza, Tanzania.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Andrew', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Simwinga', 'Affiliation': 'Department of Health, City of Dar es Salaam, Dar es Salaam, Tanzania.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Mleli', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Makongwa', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lienert', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Haberlen', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Smith Fawzi', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, United States of America.'}]",PloS one,['10.1371/journal.pone.0238240']
1609,32921337,Lurasidone and risk for metabolic syndrome: results from short- and long-term clinical studies in patients with schizophrenia.,"OBJECTIVE


To assess the effects of treatment with lurasidone on risk for metabolic syndrome (MetS) in patients with schizophrenia.
METHODS


Rates of metabolic syndrome during treatment with lurasidone (40-160 mg/d) were analyzed using pooled, short-term data from three randomized, double-blind, placebo-controlled studies (vs olanzapine and quetiapine XR); long-term data from two active-comparator-controlled studies (vs risperidone and quetiapine XR); and data from two open-label studies in which patients were switched from olanzapine or risperidone to lurasidone.
RESULTS


MetS was defined based on the National Cholesterol Education Program criteria. In short-term studies, the odds of meeting criteria for MetS at week 6 LOCF (adjusted for baseline metabolic syndrome status) was similar for the lurasidone and placebo groups (OR = 1.18; [95% CI, 0.81-1.71]; P = .39), but the odds (vs placebo) were significantly greater for olanzapine (OR = 2.81; [95% CI, 1.53-5.15]; P < .001) and quetiapine (OR = 3.49; [95% CI, 1.93-6.29]; P < .0001). No dose effect was observed for lurasidone across the dose range of 40-160 mg/d. In long-term studies, the odds of MetS after 12 months of treatment was significantly higher for risperidone compared with lurasidone (OR = 2.12; 95% CI, 1.15-3.90; P = .016) and for quetiapine XR compared with lurasidone (OR = 3.92; 95% CI, 1.15-13.40; P = .029). In open-label extension studies, the rate of MetS decreased in patients switched to lurasidone after 6 weeks of treatment with olanzapine or 12 months of treatment with risperidone.
CONCLUSION


In this analysis of lurasidone clinical trials, the odds of developing metabolic syndrome were minimal during short- and long-term treatment with lurasidone (40-160 mg/d).",2020,"; P = .39), but the odds (vs placebo) were significantly greater for olanzapine (OR = 2.81; [95% CI, 1.53-5.15]; P < .001) and quetiapine (OR = 3.49; [95% CI, 1.93-6.29]; P < .0001).","['Rates of metabolic syndrome during treatment with lurasidone (40-160\xa0mg/d', 'patients with schizophrenia']","['olanzapine', 'placebo-controlled studies (vs olanzapine and quetiapine XR', 'lurasidone', 'risperidone and quetiapine XR', 'olanzapine or risperidone to lurasidone', 'quetiapine', 'risperidone']","['Lurasidone and risk for metabolic syndrome', 'rate of MetS', 'odds of MetS']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",,0.125522,"; P = .39), but the odds (vs placebo) were significantly greater for olanzapine (OR = 2.81; [95% CI, 1.53-5.15]; P < .001) and quetiapine (OR = 3.49; [95% CI, 1.93-6.29]; P < .0001).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind, Miami, FL, USA.'}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.'}]",CNS spectrums,['10.1017/S1092852920001698']
1610,33104490,Correction to: Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,,2020,,['Patients Receiving Mechanical Thrombectomy'],['Direct Transfer to Angio-Suite Versus Computed Tomography-Transit'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}]",[],,0.0217836,,[],Stroke,['10.1161/STR.0000000000000350']
1611,33104504,Patient-Preferred Prosthetic Ankle-Foot Alignment for Ramps and Level-Ground Walking.,"Patient preference of lower limb prosthesis behavior informally guides clinical decision making, and may become increasingly important for tuning new robotic prostheses. However, the processes for quantifying preference are still being developed, and the strengths and weaknesses of preference are not adequately understood. The present study sought to characterize the reliability (consistency) of patient preference of alignment during level-ground walking, and determine the patient-preferred ankle angle for ascent and descent of a 10° ramp, with implications for the design and control of robotic prostheses. Seven subjects with transtibial amputation walked over level ground, and ascended and descended a 10° ramp on a semi-active prosthetic ankle capable of unweighted repositioning in dorsiflexion and plantarflexion. Preferred ankle angle was measured with an adaptive forced-choice psychophysics paradigm, in which subjects walked on a randomized static ankle angle and reported whether they would prefer the ankle to be dorsiflexed or plantarflexed. Subjects had reliable preferences for alignment during level-ground walking, with deviations of 1.5° from preference resulting in an 84% response rate preferring changes toward the preference. Relative to level walking, subjects preferred 7.8° (SD: 4.8°) of dorsiflexion during ramp ascent, and 5.3° (SD: 3.8°) plantarflexion during ramp descent. As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking. These findings provide baseline behaviors for prosthetic ankles capable of adapting to slopes based on patient preference, and provide strong evidence that people with transtibial amputation can finely perceive ankle alignment.",2020,"As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking.","['Seven subjects with transtibial amputation walked over level ground, and ascended and descended a 10']",['° ramp on a semi-active prosthetic ankle capable of unweighted repositioning in dorsiflexion and plantarflexion'],['socket pressures and tibial progression (shank pitch'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444675', 'cui_str': 'Shank'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}]",7.0,0.036168,"As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking.","[{'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Shepherd', 'Affiliation': ''}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Zisk', 'Affiliation': ''}, {'ForeName': 'Levi', 'Initials': 'L', 'LastName': 'Hargrove', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.3033711']
1612,33104519,Aerobic exercise induces tumor suppressor p16 INK4a  expression of endothelial progenitor cells in human skeletal muscle.,"Aerobic exercise induces oxidative stress and DNA damage, nevertheless, lowers cancer incidence. It remains unclear how genetic stability is maintained under this condition. Here, we examined the dynamic change of the tumor suppressor p16 INK4a  in cells of skeletal muscle among young men following 60-min of aerobic cycling at 70% maximal oxygen consumption (V̇O 2max ). Rg1 (5 mg, an immunostimulant ginsenoside) and placebo (PLA) were supplemented 1 h before exercise. Data from serial muscle biopsies shows unchanged p16 INK4a+  cells after exercise followed by a considerable increase (+21-fold) in vastus lateralis muscle 3 h later. This increase was due to the accumulation of endothelial progenitor cells (p16 INK4a+ /CD34 + ) surrounding myofibers and other infiltrated nucleated cells (p16 INK4a+ /CD34 - ) in necrotic myofibers. During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later. Rg1 also lowered IL-10 mRNA relative to PLA 3 h after exercise. Post-exercise increases in VEGF mRNA and CD163 +  macrophages were similar for PLA and Rg1 trials. Conclusion: The marked increases in p16 INK4a  protein expression of endothelial progenitor cells in skeletal muscle implicates a protective mechanism for maintaining genetic stability against aerobic exercise. Rg1 accelerates resolution of the exercise-induced stress response.",2020,"During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.",['human skeletal muscle'],"['Aerobic exercise', 'placebo (PLA']","['accumulation of endothelial progenitor cells', 'oxidative stress and DNA damage, nevertheless, lowers cancer incidence', 'VEGF mRNA and CD163 +  macrophages']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",,0.0901994,"During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.","[{'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Laboratory of Regenerative Medicine in Sports Science, School of Physical Education and Sports Science, South China Normal University, Guangzhou, China.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Laboratory of Exercise Nutrition, National Taichung University of Education, Taichung, Taiwan.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Saovieng', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Wei-Horng', 'Initials': 'WH', 'LastName': 'Jean', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Yang', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Chinese Medicine, Hualien Tzu Chi Hospital, Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tania Xu Yar', 'Initials': 'TXY', 'LastName': 'Lee', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Ivy', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, TX 78712, USA.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}]",Aging,['10.18632/aging.103763']
1613,33104729,Familiarity with teammate's attitudes improves team performance in virtual reality.,"Virtual reality (VR) is a potentially challenging social environment for effective communication and collaboration. Thus, we conducted a VR study to determine whether increased familiarity with a teammate would improve performance on a joint decision making task. Specifically, because attitude familiarity, or knowledge of another person's attitudes, has been correlated with better relationship functioning in the past, we anticipated that team performance would improve when teammates were first asked to discuss their task-relevant attitudes with one another. We also hypothesized that increased familiarity would be particularly useful in immersive VR, where typical social and other nonverbal cues were lacking. Twenty pairs recruited from a workplace environment were randomly assigned to either the Familiar or Control condition before completing a joint decision making task both in VR and on desktop monitors. The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes. Results found that in VR, Familiar pairs were more accurate at determining patterns to events. Additionally, for teams less experienced in VR, Familiar pairs were also more accurate at predicting future events. However, there was no meaningful statistical difference in pairs' ability to identify information. Familiar teams also took more time to answer questions, and we found no difference in self-reported communication quality. Overall, this was the first successful manipulation of attitude familiarity and results indicate that such an intervention may prove useful in a collaborative work environment, as Familiar teams demonstrated greater accuracy, especially in VR.",2020,The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes.,['Twenty pairs recruited from a workplace environment'],"['Virtual reality (VR', 'Familiar or Control condition before completing a joint decision making task both in VR and on desktop monitors']",[],"[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",[],20.0,0.0132779,The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes.,"[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Moore', 'Affiliation': 'U. S. Army Combat Capabilities and Development Command, U. S. Army Research Lab, Aberdeen Proving Ground, Maryland, United States of America.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Geuss', 'Affiliation': 'U. S. Army Combat Capabilities and Development Command, U. S. Army Research Lab, Aberdeen Proving Ground, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0241011']
1614,33104739,A randomised on-line survey exploring how health condition labels affect behavioural intentions.,"OBJECTIVES


We examined the effect of 'labels' versus 'descriptions' across four asymptomatic health conditions: pre-diabetes, pre-hypertension, mild hyperlipidaemia, and chronic kidney disease stage 3A, on participants' intentions to pursue further tests. There were four secondary objectives: 1) assessing confidence and satisfaction in their intention to test further; 2) revealing psychological drivers affecting intentions; 3) exploring whether intentions, confidence and satisfaction differ by label vs. description and health condition; and 4) producing a perceptual map of illnesses by label condition.
METHODS


Practitioner validated health-related scenarios were used. Two variants of each condition were developed. Participants were recruited through Qualtrics from Australia, Ireland and Canada and randomly assigned two 'labelled' or two 'descriptive' scenarios.
RESULTS


There was no significant difference in intentions to test between label and description conditions (95% CI -0.76 to 0.33 points, p = 0.4). Confidence and satisfaction were both positively associated with intentions: regression coefficient (β) for confidence β = 0.58 points (95% CI 0.49 to 0.68, p < .001) and for satisfaction 0.67 points (95% CI 0.57 to 0.77, p < .001). Predisposition to seek healthcare (β = 0.72; 95% CI 0.47 to 0.98), attributing illness to bad luck (β = -0.16 points; 95% CI -0.3 to -0.02), and concern about the health condition (β = 0.51; 95% CI 0.38 to 0.65) also significantly predicted intentions.
CONCLUSIONS


Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling. The average intention to test score was higher in this sample than previous symptomatic health-related studies and there was a positive relationship between increased intentions and confidence/satisfaction in one's decision. Exploratory insights suggested perceptions of the four labelled asymptomatic illnesses all shifted toward greater levels of dread and concern compared to their respective description condition.
TRIAL REGISTRATION


ACTRN12618000392268.",2020,"Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling.","[""Participants were recruited through Qualtrics from Australia, Ireland and Canada and randomly assigned two 'labelled' or two 'descriptive' scenarios"", 'Practitioner validated health-related scenarios were used']",[],"['Confidence and satisfaction', 'intentions to test between label and description conditions', 'confidence and satisfaction in their intention to test further; 2) revealing psychological drivers affecting intentions; 3) exploring whether intentions, confidence and satisfaction differ by label vs. description and health condition; and 4) producing a perceptual map of illnesses by label condition']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",2.0,0.257868,"Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling.","[{'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Spence', 'Affiliation': 'Bond Business School, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Bond Business School, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Beller', 'Affiliation': 'Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Australia.'}]",PloS one,['10.1371/journal.pone.0240985']
1615,33104822,Effect of compression fracture on trabecular bone score at lumbar spine.,"Bone mineral density (BMD) may be increased due to vertebral compression fractures (VCF). Our study showed trabecular bone scores (TBS) was less affected than BMD by fractured vertebrae. The TBS of most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity, could still be used in predicting fracture risk.
INTRODUCTION


Trabecular bone score (TBS), a noninvasive tool estimating bone microarchitecture, provides complementary information to lumbar spine bone mineral density (BMD). Lumbar spine BMD might be increased due to both degenerative disease and vertebral compression fractures (VCF). Lumbar spine TBS has been confirmed not influenced by osteoarthrosis, but the effects of VCF are still not been well evaluated. This study aimed to investigate whether lumbar spine TBS was affected by fractured vertebrae.
METHODS


We studied postmenopausal women and men above 50 years old who underwent DXA between January 1, 2017, and May 31, 2019. By calculating the difference of BMD and TBS between L1 and the mean of L2-3, the study compared the difference of values between the control group and fracture group to determine the effects of fractured vertebrae on BMD and TBS.
RESULTS


A total of 377 participants were enrolled with 202 in the control group (157 females; age: 68.06 ± 6.47 years) and 175 in the fracture group (147 females; age: 71.71 ± 9.44 years). The mean BMD of the L1 vertebrae in the fracture group was significantly higher than that in the control group (p < 0.0001). There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity.
CONCLUSION


Lumbar spine TBS, unlike BMD, is less affected by fractured vertebrae. The TBS of most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity, could still be used in predicting fracture risk.",2020,"There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity.
","['postmenopausal women and men above 50 years old who underwent DXA between January 1, 2017, and May 31, 2019', 'lumbar spine', '377 participants were enrolled with 202 in the control group (157 females; age: 68.06\xa0±\xa06.47 years) and 175 in the fracture group (147 females; age: 71.71\xa0±\xa09.44 years']",['compression fracture'],"['BMD and TBS', 'Bone mineral density (BMD', 'lumbar spine TBS', 'mean BMD of the L1 vertebrae', 'lumbar spine bone mineral density (BMD', 'trabecular bone score', 'trabecular bone scores (TBS', 'Trabecular bone score (TBS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]",377.0,0.0242367,"There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}, {'ForeName': 'T-J', 'Initials': 'TJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan. tsyhjyi.hsieh@gmail.com.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Ho', 'Affiliation': 'Department of Medical Research, Chi Mei Medical Center, Yongkang, Tainan, Taiwan.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}, {'ForeName': 'C K-H', 'Initials': 'CK', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05707-3']
1616,33104835,Subcuticular Sutures Versus Staples for Wound Closure in Open Liver Resection: A Randomised Clinical Trial.,"BACKGROUND


Subcuticular sutures reduce wound complication rates only in clean surgeries. Repeat resection is frequently required in liver surgery, due to the high recurrence rate (30-50%) of liver cancers. The aim of this study is to assess that subcuticular sutures is superior to staples in liver surgery.
METHODS


This single-centre, single-blinded, randomised controlled trial was conducted at a university hospital between January 2015 and October 2018. Patients were randomly assigned (1:1) to receive either subcuticular sutures or staples for skin closure. Three risk factors (repeat resection, diabetes mellitus and liver function) were matched preoperatively for equal allocation. The primary endpoint was the wound complication rate, while secondary endpoints were surgical site infection (SSI), duration of postoperative hospitalisation and total medical cost. Subset analyses were performed only for the 3 factors allocated as secondary endpoints.
RESULTS


Of the 581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed. As the primary outcome, the wound complication rate with subcuticular sutures (12.5%) did not differ from that with staples [15.9%; odds ratio (OR), 1.33; 95% confidence interval (CI), 0.83-2.15; p = 0.241]. As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
CONCLUSION


Subcuticular sutures were not shown to reduce wound complications compared to staples in open liver resection, but appear beneficial for repeat incisions.",2020,"As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
","['clean surgeries', 'university hospital between January 2015 and October 2018', '581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed', 'Open Liver Resection']","['subcuticular sutures', 'Subcuticular Sutures Versus Staples for Wound Closure', 'subcuticular sutures or staples for skin closure', 'Subcuticular sutures']","['wound complications', 'wound complication rate with subcuticular sutures', 'overall wound complications', 'wound complication rate', 'wound complication rates', 'risk factors (repeat resection, diabetes mellitus and liver function', 'surgical site infection (SSI), duration of postoperative hospitalisation and total medical cost']","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",581.0,0.233861,"As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
","[{'ForeName': 'Yoritaka', 'Initials': 'Y', 'LastName': 'Matsuno', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan. yamazaki-nmed@umin.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mitsuka', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Abe', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Tokio', 'Initials': 'T', 'LastName': 'Higaki', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Tadatoshi', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}]",World journal of surgery,['10.1007/s00268-020-05833-3']
1617,33104939,Smart wearable devices as a psychological intervention for healthy lifestyle and quality of life: a randomized controlled trial.,"PURPOSE


Creating a healthy lifestyle is important across different life stages. Commercial smart wearable devices are an innovative and interesting approach as an early psychological intervention for modifying health-related behaviors. Therefore, the purpose of this study was to explore the effects of smart wearable devices on health-promoting lifestyles and quality of life.
METHODS


The study design was a three-parallel randomized controlled trial with a 3-month intervention. Two commercial smart wearable devices (smartwatches and smart bracelets) with different levels of complicated functions were applied as a psychological intervention in comparison with a smartphone app as the control group. Participants were healthy young adults with a median age of 26 years. Outcome measurements were conducted by self-administered questionnaires. Chi-square tests and ANOVA were performed for testing the difference of participants at baseline, and generalized estimating equations were performed for testing the effect of the intervention.
RESULTS


At the beginning, 81 participants were recruited and 73 participants completed the study. Results of a healthy lifestyle demonstrated significant group effects of exercise and a significant effect of the interaction for self-actualization and stress management in the experimental group with a smartwatch (Self-actualization: MD = 0.35[- 0.10,0.80]; Exercise: MD = 0.21[- 0.33 0.75]; Stress management: MD = 0.36[- 0.04,0.76]) by comparing with only using mobile app (Self-actualization: MD =  - 0.03[- 0.25,0.18]; Exercise: MD =  - 0.12[- 0.38,0.14]; Stress management, MD =  - 0.28[- 0.55,0.00]). The significant effect of group-by-time interaction for self-actualization was found in the experimental group with a smart bracelet (MD = 0.05[- 0.30,0.20]) by comparing with the control group. The GEE-adjusted model indicated significant effects of the interaction on the comprehensive, physical, and mental quality of life in the experimental group with the smartwatch (Comprehensive: MD = 0.24[- 0.04,0.52]; Physical: MD = 0.67[0.26,1.09]; Mental: MD = 0.72[0.29,1.16]) by comparing with the control group (Comprehensive: MD =  - 1.57[- 2.55, - 0.59]; Physical: MD = 0.25[0.00,0.50]; Mental: MD = 0.08[- 0.11,0.27]).
CONCLUSION


From a psychological perspective, smart wearable devices have potential benefits of shaping a healthy lifestyle and improving the quality of life. Enhancing the utility of commercial well-designed smart wearable devices is an innovative and effective strategy for promoting public health.",2020,"Results of a healthy lifestyle demonstrated significant group effects of exercise and a significant effect of the interaction for self-actualization and stress management in the experimental group with a smartwatch (Self-actualization: MD = 0.35[- 0.10,0.80]; Exercise: MD = 0.21[- 0.33 0.75]; Stress management: MD = 0.36[- 0.04,0.76]) by comparing with only using mobile app (Self-actualization: MD =  - 0.03[- 0.25,0.18]; Exercise: MD =  - 0.12[- 0.38,0.14]; Stress management, MD =  - 0.28[- 0.55,0.00]).","['Participants were healthy young adults with a median age of 26\xa0years', '81 participants were recruited and 73 participants completed the study']",['smart wearable devices'],"['comprehensive, physical, and mental quality of life', 'health-promoting lifestyles and quality of life', 'self-actualization and stress management', 'healthy lifestyle and quality of life', 'quality of life']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]",81.0,0.0599759,"Results of a healthy lifestyle demonstrated significant group effects of exercise and a significant effect of the interaction for self-actualization and stress management in the experimental group with a smartwatch (Self-actualization: MD = 0.35[- 0.10,0.80]; Exercise: MD = 0.21[- 0.33 0.75]; Stress management: MD = 0.36[- 0.04,0.76]) by comparing with only using mobile app (Self-actualization: MD =  - 0.03[- 0.25,0.18]; Exercise: MD =  - 0.12[- 0.38,0.14]; Stress management, MD =  - 0.28[- 0.55,0.00]).","[{'ForeName': 'Hsin-Yen', 'Initials': 'HY', 'LastName': 'Yen', 'Affiliation': 'School of Gerontology Health Management, College of Nursing, Taipei Medical University, 250 Wuxing St., Taipei, 11031, Taiwan. yenken520@gmail.com.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02680-6']
1618,33104981,Effects of intranasal steroids on continuous positive airway pressure compliance among patients with obstructive sleep apnea.,"BACKGROUND


Continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea can produce troublesome nasal symptoms, especially congestion, which may affect the continuity of using CPAP. Intranasal steroids are often prescribed to reduce these side effects, although few recent studies exist supporting the benefits of this treatment for CPAP-induced nasal side effects.
METHODS


Eighty-three patients with OSA were enrolled in a prospective, randomized controlled study. All patients received CPAP treatment and were divided in two groups. The study group was prescribed fluticasone furoate nasal spray 55 μg, and the compliance to CPAP for patients in both groups was recorded by device memory card. Total nasal symptom score was assessed using a questionnaire by direct interview, with follow-up performed at 30 and 90 days after treatment.
RESULT


Compliance to CPAP increased in both groups with significantly greater compliance in the intranasal steroid group compared to the control group without intranasal steroid (P value = 0.002, 0.001, and 0.020, respectively) after 90 days of treatment. No difference in nasal symptoms was found between the groups after 30 days of treatment. However, adding an intranasal steroid resulted in decreased rhinorrhea and congestion symptoms (P value < 0.001 and < 0.001) after 90 days of treatment.
CONCLUSION


The addition of an intranasal steroid decreased the frequency of nasal symptoms, especially rhinorrhea and congestion, among patients with OSA initiating CPAP therapy and increased compliance to CPAP after 90 days of treatment.
TRIAL REGISTRATION


IRB approval ID: R179h Clinical trial ID: TCTR20200715001.",2020,"Compliance to CPAP increased in both groups with significantly greater compliance in the intranasal steroid group compared to the control group without intranasal steroid (P value = 0.002, 0.001, and 0.020, respectively) after 90 days of treatment.","['patients with obstructive sleep apnea', 'Eighty-three patients with OSA']","['intranasal steroids', 'Continuous positive airway pressure (CPAP', 'intranasal steroid', 'CPAP', 'fluticasone furoate nasal spray']","['Total nasal symptom score', 'nasal symptoms', 'Compliance to CPAP', 'frequency of nasal symptoms, especially rhinorrhea and congestion', 'continuous positive airway pressure compliance', 'rhinorrhea and congestion symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",83.0,0.0282741,"Compliance to CPAP increased in both groups with significantly greater compliance in the intranasal steroid group compared to the control group without intranasal steroid (P value = 0.002, 0.001, and 0.020, respectively) after 90 days of treatment.","[{'ForeName': 'Charnsiri', 'Initials': 'C', 'LastName': 'Segsarnviriya', 'Affiliation': 'Department of Otorhinolaryngology, Phramongkutklao Hospital, Bangkok, 10400, Thailand.'}, {'ForeName': 'Rutti', 'Initials': 'R', 'LastName': 'Chumthong', 'Affiliation': 'Department of Otorhinolaryngology, Phramongkutklao Hospital, Bangkok, 10400, Thailand. rutti_c@yahoo.com.'}, {'ForeName': 'Prasit', 'Initials': 'P', 'LastName': 'Mahakit', 'Affiliation': 'Department of Otorhinolaryngology, Phramongkutklao Hospital, Bangkok, 10400, Thailand.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02236-5']
1619,33105146,The Glycemic Effect of Liraglutide Evaluated by Continuous Glucose Monitoring in Persons with Type 2 Diabetes Receiving Dialysis.,"AIMS


The aim of this study was to evaluate the effect of liraglutide treatment on glucose variability and the risk of hypoglycemia by continuous glucose monitoring (CGM) in persons with type 2 diabetes (T2D) and dialysis-dependent end-stage renal disease (ESRD).
MATERIALS AND METHODS


We assessed CGM data from a previous trial where 24 persons with T2D and dialysis-dependent ESRD were allocated (1:1) to 12 weeks of double-blinded treatment with liraglutide (titrated to maximum tolerable dose up to 1.8 mg) or placebo as an add-on to preexisting antidiabetic treatment. CGM (Ipro2®; Medtronic) was performed for up to 7 days at baseline and at weeks 2, 6, and 10. A linear mixed model was used to compare the 2 study arms.
RESULTS


A CGM was worn at baseline by 12 persons in the liraglutide group and 10 in the placebo group (7 and 9 completed week 10, respectively). Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16). Comparing baseline and week 10, the number of hypoglycemic events (glucose values between <3.9 and 3.0 mmol/L) increased in the liraglutide group compared with the placebo group (p = 0.02). The occurrence of hypoglycemic events below 3.0 mmol/L was similar between the groups (p = 0.36).
CONCLUSIONS


In the present cohort of persons with T2D and dialysis-dependent ESRD, liraglutide treatment increased the risk of hypoglycemic events as compared to placebo (no difference was found for hypoglycemic events below 3.0 mmol/L). The majority of participants were co-treated with insulin.",2020,"Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16).","['persons with type 2 diabetes (T2D) and dialysis-dependent end-stage renal disease (ESRD', '24 persons with T2D and dialysis-dependent ESRD', 'Persons with Type 2 Diabetes Receiving Dialysis']","['continuous glucose monitoring (CGM', 'CGM (Ipro2®; Medtronic', 'insulin', 'Liraglutide Evaluated by Continuous Glucose Monitoring', 'liraglutide', 'placebo', 'liraglutide (titrated to maximum tolerable dose up to 1.8 mg) or placebo']","['Glycated hemoglobin A1c', 'glucose variability', 'risk of hypoglycemic events', 'occurrence of hypoglycemic events', 'number of hypoglycemic events (glucose values', 'glucose variability and the risk of hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",24.0,0.0738599,"Glycated hemoglobin A1c (p = 0.81) and glucose variability was similar between the groups (standard deviation, p = 0.33; coefficient of variation, p = 0.16).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bomholt', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, tobias.bomholt@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ajenthen G', 'Initials': 'AG', 'LastName': 'Ranjan', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marsela', 'Initials': 'M', 'LastName': 'Resuli', 'Affiliation': 'Department of Nephrology, Hillerød Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Pernille M', 'Initials': 'PM', 'LastName': 'Hansen', 'Affiliation': 'Department of Nephrology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Borg', 'Affiliation': 'Department of Nephrology, Roskilde Hospital, University of Copenhagen, Roskilde, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hornum', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Nephron,['10.1159/000510613']
1620,33105154,Morphological and functional changes of the tibialis anterior muscle following combined mirror visual feedback and electromyographic biofeedback in poststroke patients: A randomized trial.,"OBJECTIVE


To investigate the morphological and functional changes of the tibialis anterior muscle following mirror visual feedback (MVF) combined with electromyographic biofeedback (EMG-BF) in poststroke patients.
DESIGN


A total of 46 poststroke patients were randomly divided into three groups: an MVF+EMG-BF group, an MVF group, and a control group. The MVF+EMG-BF group was treated with both MVF and EMG-BF, and the MVF group was treated with MVF alone. The morphological parameters, including the pennation angle (PA), muscle thickness (MT), and fascicle length (FL), were assessed.
RESULTS


After four weeks of treatment, the PA and MT values were significantly increased in the MVF+EMG-BF and MVF groups (P<0.05). The increase of these values in the MVF+EMG-BF group were significantly greater than that for both metrics in the MVF and control groups (P<0.05), and those in the MVF group were greater than those in the control group (P<0.05). There was no significant difference in the FL value among the three groups as a result of the treatment. After the treatment, the neurological functions were all increased in three groups (P<0.05).
CONCLUSIONS


A combination of MVF and EMG-BF appears to be an effective therapy for improving the motor function of the tibialis anterior muscle in poststroke patients.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR1800017050.",2020,"After the treatment, the neurological functions were all increased in three groups (P<0.05).
","['poststroke patients', '46 poststroke patients']","['MVF alone', 'mirror visual feedback (MVF) combined with electromyographic biofeedback (EMG-BF', 'MVF+EMG-BF group, an MVF', 'combined mirror visual feedback and electromyographic biofeedback', 'MVF and EMG-BF']","['PA and MT values', 'FL value', 'neurological functions', 'pennation angle (PA), muscle thickness (MT), and fascicle length (FL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",46.0,0.0149838,"After the treatment, the neurological functions were all increased in three groups (P<0.05).
","[{'ForeName': 'Meikuai', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasonography, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Shunping', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasonography, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasonography, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001628']
1621,33105245,Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial.,"BACKGROUND


Corticosteroids can reduce pain but the optimal dose and safety profiles are still uncertain.
OBJECTIVE


This study aimed to evaluate two different doses of dexamethasone for pain management and their side effects after total knee arthroplasty.
DESIGN


A prospective randomised, controlled trial.
SETTING


A tertiary teaching hospital in Hong Kong.
PATIENTS


One hundred and forty-six patients were randomly allocated to one of three study groups.
INTERVENTIONS


Before operation, patients in group D8, D16 and P received dexamethasone 8 mg, dexamethasone 16 mg and placebo (0.9% saline), respectively.
MAIN OUTCOME MEASURES


The primary outcome was postoperative pain score. Secondary outcomes were opioid consumption, physical parameters of the knees and side effects of dexamethasone.
RESULTS


Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3 [-1.3 (95% CI, -2.2 to -0.31), P = 0.005]. There was also a significant dose-dependent trend between pain scores and dexamethasone dose (P = 0.002). Compared with placebo, patients in group D16 consumed significantly less opioid [-6.4 mg (95% CI, -11.6 to -1.2), P = 0.025] and had stronger quadriceps power on the first three postoperative days (all P < 0.05). They also had significantly longer walking distance on postoperative day 1 [7.8 m ([95% CI, 0.85 to 14.7), P = 0.023] with less assistance during walking on the first two postoperative days (all P < 0.029) and significantly better quality-of-recovery scores on postoperative day 1 (P = 0.018). There were significant dose-dependent trends between all the above parameters and dexamethasone dose (all P < 0.05). No significant differences were found in the incidence of chronic pain or knee function 3, 6 and 12 months postoperatively.
CONCLUSION


Dexamethasone 16 mg given before total knee arthroplasty led to a reduction in postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery after operation. No long-term improvement in reduction in pain and function of the knee was found.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02767882.",2020,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","['One hundred and forty-six patients', 'pain relief after total knee arthroplasty', 'A tertiary teaching hospital in Hong Kong', 'total knee arthroplasty']","['dexamethasone', 'Dexamethasone', 'placebo', 'dexamethasone 8\u200amg, dexamethasone 16\u200amg and placebo', 'Preoperative dexamethasone']","['longer walking distance', 'opioid consumption, physical parameters of the knees and side effects of dexamethasone', 'quality-of-recovery scores', 'pain', 'chronic pain or knee function', 'postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery', 'pain and function of the knee', 'pain during maximal active flexion', 'pain scores', 'postoperative pain score']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",146.0,0.535529,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","[{'ForeName': 'Timmy Chi Wing', 'Initials': 'TCW', 'LastName': 'Chan', 'Affiliation': 'From the Department of Anaesthesiology, Queen Mary Hospital (TCWC, AYFC), Department of Anaesthesiology, University of Hong Kong (CWC, SSCW, MGI), Department of Orthopaedics and Traumatology, Queen Mary Hospital (PKC, HF), Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong, China (CHY, KYC).'}, {'ForeName': 'Chi Wai', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Stanley Sau Ching', 'Initials': 'SSC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Arthur Yu Fai', 'Initials': 'AYF', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Irwin', 'Affiliation': ''}, {'ForeName': 'Ping Keung', 'Initials': 'PK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Chun Hoi', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Kwong Yuen', 'Initials': 'KY', 'LastName': 'Chiu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001372']
1622,33105246,"Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block: A patient and assessor-blind, randomised controlled trial.","BACKGROUND


Ultrasound-guided interscalene brachial plexus block (ISB) is used to control pain after shoulder surgery. Though effective, drawbacks include phrenic nerve block and motor block of the hand. The ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB) may provide a good alternative.
OBJECTIVE


To compare lung ventilation and diaphragmatic activity on the operated side in ISB and SSNB.
DESIGN


Randomised, controlled patient-blinded and assessor-blinded trial.
SETTING


Outpatient surgical clinic with recruitment from June 2017 to January 2018.
PATIENTS


Fifty-five outpatients scheduled for arthroscopic shoulder surgery were allocated randomly to receive SSNB or ISB. Technical problems with monitoring devices unrelated to the intervention led to exclusion of seven patients. The remaining 48 (n=24 in each group) were followed up for 24 h without drop-outs.
INTERVENTIONS


Patients received 10 ml of ropivacaine 1.0% wt/vol for both procedures.
OUTCOME MEASURES


Percentage lung ventilation on the operated side was the primary endpoint as assessed with electrical impedance tomography (EIT). Secondary endpoints were hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction.
RESULTS


Before regional anaesthesia, the lung on the operated side contributed a median [IQR] of 50 [42 to 56]% of the total lung ventilation. Postoperatively, it was 40 [3 to 50]% (SSNB) vs. 3 [1 to 13]% (ISB) for an adjusted difference of 23 (95% CI, 13 to 34)%, (P < 0.001). Hemidiaphragmatic motion was 1.90 (95% CI, 1.37 to 2.44 cm), (P < 0.001) lower in the ISB group compared with the SSNB group. Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001. Pain was low in the first 6 h after surgery in both groups with slightly, but not significantly, lower values for ISB. No meaningful or significant differences were found for opioid use or patient satisfaction.
CONCLUSION


An ultrasound-guided anterior approach to SSNB preserves ipsilateral lung ventilation and phrenic function better than a standard interscalene block.
TRIAL REGISTRATION


drks.de identifier: DRKS00011787.",2020,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","['Fifty-five outpatients scheduled for arthroscopic shoulder surgery', 'Outpatient surgical clinic with recruitment from June 2017 to January 2018']","['SSNB or ISB', 'Ultrasound-guided interscalene brachial plexus block (ISB', 'ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB', 'Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block', 'ropivacaine 1.0%\u200awt/vol for both procedures']","['Hand strength', 'hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction', 'electrical impedance tomography (EIT', 'lung ventilation and diaphragmatic activity', 'Pain', 'ipsilateral lung ventilation and phrenic function', 'opioid use or patient satisfaction', 'Hemidiaphragmatic motion', 'SSNB and numbness']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0559305', 'cui_str': 'Differential lung ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]",55.0,0.14646,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'David Petroff and Martin Wiegel contributed equally.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiegel', 'Affiliation': 'David Petroff and Martin Wiegel contributed equally.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Pech', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Salz', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mrongowius', 'Affiliation': ''}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001367']
1623,33105261,Objective Assessment of Speech Intelligibility in Crowded Public Spaces.,"The objective of this study was to obtain a normative database of speech intelligibility data for young normal-hearing listeners communicating in public spaces. A total of 174 listeners participated in an interactive speech intelligibility task that required four-person groups to conduct a live version of the Modified Rhyme Test in noisy public spaces. The public spaces tested included a college library, a college cafeteria, a casual dining restaurant during lunch hour, and a crowded bar during happy hour. At the start of each trial, one of the participants was randomly selected as the talker, and a tablet computer was used to prompt them to say a word aloud from the Modified Rhyme Test. Then, the other three participants were required to select this word from one of six rhyming alternatives displayed on three other tablet computers. The tablet computers were also used to record the SPL at each listener location during and after the interval where the target talker was speaking. These SPL measurements were used to estimate the signal-to-noise ratio (SNR) in each trial of the experiment. As expected, the results show that speech intelligibility decreases, response time increases, and perceived difficulty increases as the background noise level increases. There was also a systematic decrease in SNR with increasing background noise, with SNR decreasing 0.44 dB for every 1 dB increase in ambient noise level above 60 dB. Overall, the results of this study have demonstrated how low-cost tablet computer-based data collection systems can be used to collect live-talker speech intelligibility data in real-world environments. We believe these techniques could be adapted for use in future studies focused on obtaining ecologically valid assessments of the effects of age, hearing impairment, amplification, and other factors on speech intelligibility performance in real-world environments.",2020,"There was also a systematic decrease in SNR with increasing background noise, with SNR decreasing 0.44 dB for every 1 dB increase in ambient noise level above 60 dB.","['Crowded Public Spaces', 'The public spaces tested included a college library, a college cafeteria, a casual dining restaurant during lunch hour, and a crowded bar during happy hour', '174 listeners participated in an', 'young normal-hearing listeners communicating in public spaces']",['interactive speech intelligibility task that required four-person groups to conduct a live version of the Modified Rhyme Test in noisy public spaces'],"['ambient noise level', 'Speech Intelligibility']","[{'cui': 'C0010383', 'cui_str': 'Crowding'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023621', 'cui_str': 'Library'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}]",174.0,0.0208267,"There was also a systematic decrease in SNR with increasing background noise, with SNR decreasing 0.44 dB for every 1 dB increase in ambient noise level above 60 dB.","[{'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Brungart', 'Affiliation': 'Audiology and Speech Pathology Center, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Barrett', 'Affiliation': 'Department of Hearing and Speech Sciences, University of Maryland, College Park, MD.'}, {'ForeName': 'Julie I', 'Initials': 'JI', 'LastName': 'Cohen', 'Affiliation': 'Department of Hearing and Speech Sciences, University of Maryland, College Park, MD.'}, {'ForeName': 'Calli', 'Initials': 'C', 'LastName': 'Fodor', 'Affiliation': 'Department of Hearing and Speech Sciences, University of Maryland, College Park, MD.'}, {'ForeName': 'Calli M', 'Initials': 'CM', 'LastName': 'Yancey', 'Affiliation': 'Department of Hearing and Speech Sciences, University of Maryland, College Park, MD.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gordon-Salant', 'Affiliation': 'Department of Hearing and Speech Sciences, University of Maryland, College Park, MD.'}]",Ear and hearing,['10.1097/AUD.0000000000000943']
1624,33105281,An Implementation-Effectiveness Study of a Perioperative Delirium Prevention Initiative for Older Adults.,"BACKGROUND


Postoperative delirium is a common and serious problem for older adults. To better align local practices with delirium prevention consensus guidelines, we implemented a 5-component intervention followed by a quality improvement (QI) project at our institution.
METHODS


This hybrid implementation-effectiveness study took place at 2 adult hospitals within a tertiary care academic health care system. We implemented a 5-component intervention: preoperative delirium risk stratification, multidisciplinary education, written memory aids, delirium prevention postanesthesia care unit (PACU) orderset, and electronic health record enhancements between December 1, 2017 and June 30, 2018. This was followed by a department-wide QI project to increase uptake of the intervention from July 1, 2018 to June 30, 2019. We tracked process outcomes during the QI period, including frequency of preoperative delirium risk screening, percentage of ""high-risk"" screens, and frequency of appropriate PACU orderset use. We measured practice change after the interventions using interrupted time series analysis of perioperative medication prescribing practices during baseline (December 1, 2016 to November 30, 2017), intervention (December 1, 2017 to June 30, 2018), and QI (July 1, 2018 to June 30, 2019) periods. Participants were consecutive older patients (≥65 years of age) who underwent surgery during the above timeframes and received care in the PACU, compared to a concurrent control group <65 years of age. The a priori primary outcome was a composite of perioperative American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use (Beers PIM) medications. The secondary outcome, delirium incidence, was measured in the subset of older patients who were admitted to the hospital for at least 1 night.
RESULTS


During the 12-month QI period, preoperative delirium risk stratification improved from 67% (714 of 1068 patients) in month 1 to 83% in month 12 (776 of 931 patients). Forty percent of patients were stratified as ""high risk"" during the 12-month period (4246 of 10,494 patients). Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12. We analyzed medication use in 7212, 4416, and 8311 PACU care episodes during the baseline, intervention, and QI periods, respectively. Beers PIM administration decreased from 33% to 27% to 23% during the 3 time periods, with adjusted odds ratio (aOR) 0.97 (95% confidence interval [CI], 0.95-0.998; P = .03) per month during the QI period in comparison to baseline. Delirium incidence was 7.5%, 9.2%, and 8.5% during the 3 time periods with aOR of delirium of 0.98 (95% CI, 0.91-1.05, P = .52) per month during the QI period in comparison to baseline.
CONCLUSIONS


A perioperative delirium prevention intervention was associated with reduced administration of Beers PIMs to older adults.",2020,Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12.,"['older adults', 'Participants were consecutive older patients (≥65 years of age) who underwent surgery during the above timeframes and received care in the PACU, compared to a concurrent control group <65 years of age', 'Older Adults', '7212, 4416, and 8311 PACU care episodes during the baseline, intervention, and QI periods, respectively', '2 adult hospitals within a tertiary care academic health care system']","['5-component intervention: preoperative delirium risk stratification, multidisciplinary education, written memory aids, delirium prevention postanesthesia care unit (PACU', 'Perioperative Delirium Prevention Initiative']","['preoperative delirium risk stratification', 'frequency of preoperative delirium risk screening, percentage of ""high-risk"" screens, and frequency of appropriate PACU orderset use', 'delirium incidence', 'composite of perioperative American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use (Beers PIM) medications', 'Delirium incidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085554', 'cui_str': 'Episodes of Care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4042847', 'cui_str': 'de Beers Criteria'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",10494.0,0.0624519,Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12.,"[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Donovan', 'Affiliation': 'From the Division of Critical Care Medicine, Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'Matthias R', 'Initials': 'MR', 'LastName': 'Braehler', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Robinowitz', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Department of Preventive and Dental Sciences.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Finlayson', 'Affiliation': 'Department of Surgery and Philip R. Lee Institute for Health Policy Studies.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Division of Geriatrics, Department of Medicine.'}, {'ForeName': 'Vanja C', 'Initials': 'VC', 'LastName': 'Douglas', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005223']
1625,33105308,Tranexamic acid administration in the field does not affect admission thromboelastography after traumatic brain injury.,"BACKGROUND


No Food and Drug Administration-approved medication improves outcomes following traumatic brain injury (TBI). A forthcoming clinical trial that evaluated the effects of two prehospital tranexamic acid (TXA) dosing strategies compared with placebo demonstrated no differences in thromboelastography (TEG) values. We proposed to explore the impact of TXA on markers of coagulation and fibrinolysis in patients with moderate to severe TBI.
METHODS


Data were extracted from a placebo-controlled clinical trial in which patients 15 years or older with TBI (Glasgow Coma Scale, 3-12) and systolic blood pressure of ≥90 mm Hg were randomized prehospital to receive placebo bolus/placebo infusion (placebo), 1 g of TXA bolus/1 g of TXA infusion (bolus maintenance), or 2 g of TXA bolus/placebo infusion (bolus only). Thromboelastography was performed, and coagulation measures including prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, D-dimer, plasmin-antiplasmin (PAP), thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1 were quantified at admission and 6 hours later.
RESULTS


Of 966 patients receiving study drug, 700 had laboratory tests drawn at admission and 6 hours later. There were no statistically significant differences in TEG values, including LY30, between groups (p > 0.05). No differences between prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1 were demonstrated across treatment groups. Concentrations of D-dimer in TXA treatment groups were less than placebo at 6 hours (p < 0.001). Concentrations of PAP in TXA treatment groups were less than placebo on admission (p < 0.001) and 6 hours (p = 0.02). No differences in D-dimer and PAP were observed between bolus maintenance and bolus only.
CONCLUSION


While D-dimer and PAP levels reflect a lower degree of fibrinolysis following prehospital administration of TXA when compared with placebo in a large prehospital trial of patients with TBI, TEG obtained on admission and 6 hours later did not demonstrate any differences in fibrinolysis between the two TXA dosing regimens and placebo.
LEVEL OF EVIDENCE


Diagnostic test, level III.",2020,"There were no statistically significant differences in TEG values, including LY30, between groups (p > 0.05).","['patients 15 years or older with TBI (Glasgow Coma Scale, 3-12) and systolic blood pressure of ≥90 mm Hg', 'patients with moderate to severe TBI', 'traumatic brain injury (TBI', '966 patients receiving study drug, 700 had laboratory tests drawn at admission and 6 hours later']","['placebo bolus/placebo infusion (placebo', 'Thromboelastography', 'prehospital tranexamic acid (TXA', 'placebo', 'TXA bolus/1 g of TXA infusion (bolus maintenance), or 2 g of TXA bolus/placebo', 'TXA', 'Tranexamic acid']","['D-dimer and PAP', 'prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1', 'prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, D-dimer, plasmin-antiplasmin (PAP), thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1 were quantified at admission and 6 hours later', 'thromboelastography (TEG) values', 'Concentrations of PAP', 'TEG values', 'fibrinolysis', 'Concentrations of D-dimer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0003410', 'cui_str': 'Antiplasmin'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}]",966.0,0.31204,"There were no statistically significant differences in TEG values, including LY30, between groups (p > 0.05).","[{'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Dixon', 'Affiliation': ""From the Departments of Surgery (A.L.D., B.H.M., E.A.R., E.D., D.H.F., S.E.R., M.A.S., M.F.) and Emergency Medicine (J. Jui), Oregon Health and Science University, Portland, Oregon; Departments of Emergency Medicine (J.M.) and Surgery (J. Johannigman), University of Cincinnati, Cincinnati, Ohio; Departments of Surgery (B.R.H.R., E.M.B., P.K.) and Biostatistics (D.K., B.M., E.N.M., S.M., K.S., J.H.), University of Washington, Seattle, Washington; Trauma Surgery (B.T.), Texas Health Presbyterian Hospital; Department of Emergency Medicine (J.S.G.), Baylor University Medical Center, Dallas, Texas; Johns Hopkins School of Medicine (M.L.W.), Baltimore, Maryland; Department of Emergency Medicine (T.P.A., M.R.C.), Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Emergency Medicine (J.M.T., J.C.), University of British Columbia, Vancouver, British Columbia, Canada; Department of Surgery (S.E.R.), Scripps Memorial Hospital La Jolla, La Jolla, California; Departments of Emergency Medicine (A.H.I.) and Internal Medicine (A.H.I.), University of Texas Southwestern Medical Center, Dallas, Texas; Providence Health Care Research Institute (J.C.), Vancouver, British Columbia, Canada; Rescu, Li Ka Shing Knowledge Institute (L.J.M.), and Department of Surgery (S.R.), St. Michael's Hospital; Division of Emergency Medicine, Department of Medicine Faculty of Medicine (L.J.M.), and Department of Laboratory Medicine and Pathobiology (J.C.), University of Toronto, Toronto, Ontario, Canada; Departments of Emergency Medicine (R.J.F.) and Surgery (D.J.D.), Regions Hospital, St. Paul, Minnesota; Department of Surgery (C.W., P.L.B.), University of Alabama, Birmingham, Alabama; Department of Surgery (C.E.W., B.A.C., L.E.V.), McGovern Medical School, University of Texas Health Science Center, Houston, Texas; Department of Laboratory Medicine and Molecular Diagnostics (J.C.), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Departments of Emergency Medicine (N.J.R.) and Surgery (R.R.G.), John Peter Smith Health Network, Fort Worth, Texas; Department of Surgery (M.D.Z., M.F.), Mayo Clinic, Rochester, Minnesota; British Columbia Emergency Health Services (J.M.T., R.S.), Vancouver, British Columbia, Canada; Department of Emergency Medicine (L.K., A.H.), Hennepin County Medical Center, Minneapolis, Minnesota; Department of Surgery (S.R.), St. Michael's Hospital, Toronto, Ontario, Canada; Department of Emergency Medicine (M.G.), Medical City Plano, Plano; Emergency Medicine (R.S.), Methodist Dallas Medical Center, Dallas, Texas; National Heart, Lung, and Blood Institute, National Institutes of Health (G.S.), Bethesda, Maryland; and Department of Trauma Surgery (W.W.), Texas Health Harris Methodist Hospital, Fort Worth, Texas.""}, {'ForeName': 'Belinda H', 'Initials': 'BH', 'LastName': 'McCully', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Rick', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dewey', 'Affiliation': ''}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Farrell', 'Affiliation': ''}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': ''}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tibbs', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dries', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jui', 'Affiliation': ''}, {'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Gandhi', 'Affiliation': ''}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Garrett', 'Affiliation': ''}, {'ForeName': 'Myron L', 'Initials': 'ML', 'LastName': 'Weisfeldt', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': ''}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Frascone', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tallon', 'Affiliation': ''}, {'ForeName': 'Delores', 'Initials': 'D', 'LastName': 'Kannas', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002932']
1626,33105353,Effect of β-Alanine Supplementation on Monocyte Recruitment and Cognition During a 24-Hour Simulated Military Operation.,"Wells, AJ, Varanoske, AN, Coker, NA, Kozlowski, GJ, Frosti, CL, Boffey, D, Harat, I, Jahani, S, Gepner, Y, and Hoffman, JR. Effect of β-alanine supplementation on monocyte recruitment and cognition during a 24-hour simulated military operation. J Strength Cond Res 34(11): 3042-3054, 2020-Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain. This study examined the effect of beta-alanine (BA) on cognition and monocyte recruitment during a simulated 24-hour SUSOP. Nineteen healthy men ingested 12-g/d BA or placebo for 14 days before an SUSOP. Monocyte chemoattractant protein-1 (MCP-1), C-C chemokine receptor-2 (CCR2), and macrophage-1-antigen (CD11b) expression were assessed through multiplex assay and flow cytometry. Psychological stress and cognition were assessed through Automated Neuropsychological Assessment Metrics (ANAM). A composite measure of cognition (COGcomp) was generated from throughput scores extracted from 7 ANAM cognitive tests. Assessments occurred at baseline (0H), 12 hours (12H), 18 hours (18H), and 24 hours (24H). Significance was accepted at p ≤ 0.05. No significant effect of BA was noted for any variable (p's > 0.05). The frequency and severity of symptoms of psychological stress increased significantly at 18 and 24H compared with 0 and 12H (p's < 0.05). COGcomp decreased significantly at 18 and 24H compared with 0 and 12H (p's ≤ 0.001). MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (p's < 0.001). CCR2 expression was significantly lower at 12 (p = 0.031), 18, and 24H (p's < 0.001). CD11b expression was significantly higher at 12H (p = 0.039) and 24H (p's = 0.003). MCP-1 was negatively associated with COGcomp (β = -0.395, p = 0.002, r2 = 0.174). Neither CCR2 or CD11b was related to COGcomp (p's > 0.05). Cognitive dysfunction during SUSOPs is related to serum concentrations of MCP-1 but is not influenced by BA supplementation.",2020,MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (,"['J Strength Cond Res 34(11', 'Nineteen healthy men ingested 12-g/d BA or']","['2020-Sustained military operations (SUSOPs', 'placebo', 'β-alanine supplementation', 'beta-alanine (BA', 'β-Alanine Supplementation']","['cognition and monocyte recruitment', 'COGcomp', 'Monocyte Recruitment and Cognition', 'Psychological stress and cognition', 'cognition (COGcomp', 'MCP-1', 'CCR2 expression', 'frequency and severity of symptoms of psychological stress', 'Cognitive dysfunction', 'Monocyte chemoattractant protein-1', 'BA', 'Wells, AJ, Varanoske, AN, Coker, NA, Kozlowski, GJ, Frosti, CL, Boffey, D, Harat, I, Jahani, S, Gepner, Y, and Hoffman, JR', 'MCP-1), C-C chemokine receptor-2 (CCR2), and macrophage-1-antigen (CD11b) expression', 'CCR2 or CD11b', 'CD11b expression']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0282552', 'cui_str': 'beta-Chemokines'}, {'cui': 'C0079785', 'cui_str': 'Receptor, Complement 3'}, {'cui': 'C1136310', 'cui_str': 'Lymphocyte antigen CD11b'}]",19.0,0.0417004,MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (,"[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Wells', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Varanoske', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Coker', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Kozlowski', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Cheyanne L', 'Initials': 'CL', 'LastName': 'Frosti', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boffey', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Harat', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Jahani', 'Affiliation': 'Accreditation, Assessment and Analytics, College of Community Innovation and Education, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, and Sylvan Adams Sports Institute, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Hoffman', 'Affiliation': 'Department of Molecular Biology, Ariel University, Ariel, Israel.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003809']
1627,33105357,A Pedagogical Approach to Integrative Neuromuscular Training to Improve Motor Competence in Children: A Randomized Controlled Trail.,"Font-Lladó, R, López-Ros, V, Montalvo, AM, Sinclair, G, Prats Puig, A, and Fort-Vanmeerhaeghe, A. A pedagogical approach to integrative neuromuscular training to improve motor competence in children: a RCT. J Strength Cond Res 34(11): 3078-3085, 2020-To assess the effectiveness of a pedagogical approach to an integrative neuromuscular training (INT) program as a warm-up in physical education (PE) lessons in healthy children: (a) to improve the level of motor competence (MC) and (b) to master fundamental motor skills (FMS) patterns, considering the baseline MC level and the time spent when performing different motor tasks. One hundred ninety students (7.43 ± 0.32 years; 52% girls) were included in this randomized controlled trail and grouped up according to MC basal levels (L1-L4). Motor competence and FMS patterns (CAMSA protocol) were assessed before and after the intervention in a group-based INT warm-up (n = 97) and a group-based conventional warm-up (n = 93). The INT program improved MC (p < 0.001; d = 0.71) and FMS (p < 0.001, d = 0.52). The independent predictors of MC change were: baseline MC level (β = -196; p < 0.012), time spent to perform the task (β = -0.235 p < 0.003), and participation in the INT program (β = 0.201; p < 0.005), explaining 71% of its variability. The INT warm-up shows correlations between improvements in MC in relation to time reduction (L1 p = 0.016, d, L2 p = 0.001, and L4 = 0.001) and FMS patterns (L1 p < 0.001, L2 p < 0.003, L3 p < 0.005, and L4 < 0.001) Moreover, only L3, it showed correlation between changes in time and FMS mastery (p = 0.001). Our results showed that a pedagogical approach to an INT program developed as a warm-up in primary school PE lessons can improve MC and FMS patterns in all subjects, independent of the initial MC level. More interestingly, only in L3, the improvement in MC can be explained by the balance in time required to perform the task and the level of improvement in FMS patterns.",2020,"The INT program improved MC (p < 0.001; d = 0.71) and FMS (p < 0.001, d = 0.52).","['healthy children', 'J Strength Cond Res 34(11', 'children', 'One hundred ninety students (7.43 ± 0.32 years; 52% girls', 'Children']","['Integrative Neuromuscular Training', 'pedagogical approach to an integrative neuromuscular training (INT) program as a warm-up in physical education (PE) lessons']","['Motor competence and FMS patterns (CAMSA protocol', 'FMS patterns', 'FMS', 'time and FMS mastery', 'MC and FMS patterns', 'time spent to perform the task']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",,0.0277971,"The INT program improved MC (p < 0.001; d = 0.71) and FMS (p < 0.001, d = 0.52).","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Font-Lladó', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'López-Ros', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Montalvo', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Sinclair', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Prats-Puig', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Azahara', 'Initials': 'A', 'LastName': 'Fort-Vanmeerhaeghe', 'Affiliation': 'Department of Sports Sciences, FPCEE and FCS Blanquerna, Ramon Llull University, Barcelona, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003772']
1628,33105359,Comparison Between Full-Body vs. Split-Body Resistance Exercise on the Brain-Derived Neurotrophic Factor and Immunometabolic Response.,"Lira, FS, Conrado de Freitas, M, Gerosa-Neto, J, Cholewa, JM, and Rossi, FE. Comparison between full-body vs. split-body resistance exercise on the brain-derived neurotrophic factor immunometabolic response. J Strength Cond Res 34(11): 3094-3102, 2020-Intense aerobic exercise seems to increase serum concentrations of brain-derived neurotrophic factor (BDNF) in conjunction with increasing lactate; however, less is known about the BDNF response to differing resistance exercise protocols. We hypothesized that full-body (FB) resistance exercise will elicit a greater increase in serum BDNF and lactate compared with split-body resistance exercise. Twelve recreationally resistance-trained men (age = 25.3 ± 5.9 years) performed 3 randomized trials of 18 sets of exercise: upper-body (UB), lower-body (LB), and FB conditions. Serum BDNF levels were assessed at rest, immediately Post-exercise, Post-1 hour, and Post-2 hours during recovery. Lactate concentration was evaluated at rest, after 9 sets, Post-exercise, Post-5, Post-10, and Post-30 minutes during recovery. In addition, interleukin (IL-6 and IL-10) and the IL-6/IL-10 ratio were calculated. Lactate concentration and total volume were greater in the FB condition compared with LB and UB (p < 0.05). For BDNF, effect sizes were largest in the LB (1.4), followed by the FB (0.75), and moderate to UB (0.33), although no significant differences were observed between conditions. There was a statistically significant relationship between lactate and BDNF only for LB condition (rho = 0.72; p = 0.013). There were a greater IL-10 Post-1 hour for FB condition compared with UB and LB (p < 0.001), and lower IL-6/IL-10 ratio in FB compared with UB (p < 0.001). Lower body induced a great BDNF response, and FB resistance exercise elicited a greater increase of serum cytokines than UB in trained men. We speculate that the volume of work performed by larger muscles has a larger influence on BDNF than overall volume.",2020,Lactate concentration and total volume were greater in the FB condition compared with LB and UB (p < 0.05).,"['J Strength Cond Res 34(11', 'Twelve recreationally resistance-trained men (age = 25.3 ± 5.9 years']","['full-body (FB) resistance exercise', 'Full-Body vs. Split-Body Resistance Exercise', 'full-body vs. split-body resistance exercise']","['Brain-Derived Neurotrophic Factor and Immunometabolic Response', 'interleukin (IL-6 and IL-10) and the IL-6/IL-10 ratio', 'lactate and BDNF only for LB condition', 'IL-6/IL-10 ratio', 'serum concentrations of brain-derived neurotrophic factor (BDNF', 'Lactate concentration', 'Lactate concentration and total volume', 'Serum BDNF levels', 'Lira, FS, Conrado de Freitas, M, Gerosa-Neto, J, Cholewa, JM, and Rossi, FE', 'serum cytokines', 'serum BDNF and lactate']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.0368369,Lactate concentration and total volume were greater in the FB condition compared with LB and UB (p < 0.05).,"[{'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Department of Physical Education, Exercise and Immunometabolism Research Group, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Conrado de Freitas', 'Affiliation': 'Department of Physical Education, Skeletal Muscle Assessment Laboratory, School of Technology and Sciences, São Paulo State University, Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Department of Physical Education, Exercise and Immunometabolism Research Group, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Cholewa', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Conway, South Carolina.'}, {'ForeName': 'Fabrício E', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Department of Physical Education, Immunometabolism of Skeletal Muscle and Exercise Research Group, Federal University of Piauí (UFPI), Teresina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002653']
1629,33093030,'Be on the TEAM' Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents.,"INTRODUCTION


Capsular group B  Neisseria meningitidis  (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B 'substitute' vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal  Neisseria  spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease.
METHODS AND ANALYSIS


The 'Be on the TEAM' (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16-19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other  Neisseria  spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development.
ETHICS AND DISSEMINATION


This study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools.
TRIAL REGISTRATION NUMBERS


ISRCTN75858406; Pre-results, EudraCT 2017-004609-42.",2020,Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines.,"['pharyngeal carriage of meningococci in adolescents', 'oropharyngeal carriage of pathogenic meningococci in teenagers', 'Teenagers Against Meningitis', '24\u2009000 students aged 16-19\u2009years in their penultimate year of secondary school across the UK with regional allocation to a 0+6\u2009month schedule of 4CMenB or MenB-fHbp or to a control group']","['Capsular group B  Neisseria meningitidis  (MenB', '4CMenB or MenB-fHbp vaccination', '4CMenB or MenB-fHbp']","['carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X', 'carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other  Neisseria  spp']","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3661526', 'cui_str': 'Genogroup'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",24000.0,0.184134,Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines.,"[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK jeremy.carr@paediatrics.ox.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder', 'Initials': 'P', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'MacLennan', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Meningococcal Reference Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Meningococcal Reference Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'School of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin C J', 'Initials': 'MCJ', 'LastName': 'Maiden', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037358']
1630,33093036,Development and internal validation of prognostic models to predict negative health outcomes in older patients with multimorbidity and polypharmacy in general practice.,"BACKGROUND


Polypharmacy interventions are resource-intensive and should be targeted to those at risk of negative health outcomes. Our aim was to develop and internally validate prognostic models to predict health-related quality of life (HRQoL) and the combined outcome of falls, hospitalisation, institutionalisation and nursing care needs, in older patients with multimorbidity and polypharmacy in general practices.
METHODS


Design : two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502).  Population : ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia.  Outcomes : combined outcome of falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL (after 6 and 9 months) (trial data).  Predictor variables in both data sets : age, sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation.  Predictor variables exclusively in trial data : additional socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L).  Analysis : mixed regression models, combined with stepwise variable selection, 10-fold cross validation and sensitivity analyses.
RESULTS


Most important predictors of EQ-5D-3L at 6 months in best model (Nagelkerke's R² 0.507) were depressive symptoms (-2.73 (95% CI: -3.56 to -1.91)), MAI (-0.39 (95% CI: -0.7 to -0.08)), baseline EQ-5D-3L (0.55 (95% CI: 0.47 to 0.64)). Models based on claims data and those predicting long-term outcomes based on both data sets produced low R² values. In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
CONCLUSIONS


Best trial data-based model predicted HRQoL after 6 months well and included parameters of well-being not found in claims. Performance of claims data-based models and models predicting long-term outcomes was relatively weak. For generalisability, future studies should refit models by considering parameters representing well-being and functional status.",2020,"In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
","['older patients with multimorbidity and polypharmacy in general practice', 'Population : ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia', 'Design : two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502', 'older patients with multimorbidity and polypharmacy in general practices']",[],"['MAI', 'sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation', 'falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL', 'socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L', 'depressive symptoms', 'baseline EQ-5D-3L']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0935162,"In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
","[{'ForeName': 'Beate S', 'Initials': 'BS', 'LastName': 'Müller', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany b.mueller@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ihle', 'Affiliation': 'PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'von Buedingen', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Beyer', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Ferdinand M', 'Initials': 'FM', 'LastName': 'Gerlach', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perera', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Valderas', 'Affiliation': 'APEx Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, Devon, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glasziou', 'Affiliation': 'Centre for Research in Evidence-Based Practice, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'van den Akker', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-039747']
1631,33094666,An evaluation of olaparib for the treatment of pancreatic cancer.,"INTRODUCTION


Advanced pancreatic cancer remains a lethal, incurable malignancy. Chemotherapy is the mainstay of systemic therapy consideration in metastatic pancreas cancer. Homologous recombinant DNA repair mutations are reported in about 7% of pancreas cancer cases and have rapidly emerged as actionable mutations.
AREAS COVERED


A review was conducted of publications of PARP inhibitors in pancreatic malignancies with a focus on clinical trials with olaparib. This included a review of the phase II and phase III clinical trials of olaparib in pancreatic cancer.
EXPERT OPINION


Olaparib was compared to placebo in a randomized double blind trial in cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy. Olaparib significantly improved progression free survival, [HR = -.53,  p  = 0.0035] but did not improve overall survival. No differences in quality of life were noted between the two arms. Adverse events from olaparib were noted in 40% of treated patients. Objective response rate was 20% in olaparib arm and 10% in placebo treated arm. A careful consideration of the risks and benefits of this personalized therapy is advisable, prior to clinical application in germline BRCA1/2 mutated advanced pancreatic cancer.",2020,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","['cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy', 'metastatic pancreas cancer', 'pancreatic cancer', 'germline BRCA1/2 mutated advanced pancreatic cancer']","['PARP inhibitors', 'Chemotherapy', 'placebo', 'Olaparib']","['Objective response rate', 'quality of life', 'progression free survival', 'overall survival']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.296974,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","[{'ForeName': 'Ulka N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Internal Medicine/Oncology, University of Michigan , Ann Arbor, MI, USA.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2020.1837113']
1632,33094799,"An Expression of Concern from the AJCN Editorial Office about: Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial.",,2020,,['gestational diabetes'],"['placebo', 'Magnesium supplementation']",['metabolic status and pregnancy outcomes'],"[{'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.69049,,"[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': ''}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidarzadeh', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Benisi-Kohansal', 'Affiliation': ''}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Surkan', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa320']
1633,33094821,"An Expression of Concern from the AJCN Editorial Office about: Effects of vitamin D supplementation on glucose metabolism, lipid concentrations, inflammation, and oxidative stress in gestational diabetes: a double-blind randomized controlled clinical trial.",,2020,,['gestational diabetes'],['vitamin D supplementation'],"['glucose metabolism, lipid concentrations, inflammation, and oxidative stress']","[{'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.64095,,"[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Teibeh', 'Initials': 'T', 'LastName': 'Hashemi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': ''}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa319']
1634,33094956,Feasibility of a Very Low Calorie Diet to Achieve a Sustainable 10% Weight Loss in Patients With Nonalcoholic Fatty Liver Disease.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is the most common liver condition worldwide. A weight loss goal of ≥10% is the recommended treatment for NAFLD; however, only a minority of patients achieve this level of weight reduction with standard dietary approaches. This study aimed to determine whether a very low calorie diet (VLCD) is an acceptable and feasible therapy to achieve and maintain a ≥10% weight loss in patients with clinically significant NAFLD.
METHODS


Patients with clinically significant NAFLD were recruited to a VLCD (∼800 kcal/d) intervention using meal replacement products. Anthropometrics, blood tests (liver and metabolic), liver stiffness, and cardiovascular disease risk were measured at baseline, post-VLCD, and at 9-month follow-up.
RESULTS


A total of 45 patients were approached of which 30 were enrolled 27 (90%) completed the VLCD intervention, and 20 (67%) were retained at 9-month follow-up. The VLCD was acceptable to patients and feasible to deliver. Intention-to-treat analysis found that 34% of patients achieved and sustained ≥10% weight loss, 51% achieved ≥7% weight loss, and 68% achieved ≥5% weight loss at 9-month follow-up. For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
DISCUSSION


VLCD offers a feasible treatment option for some patients with NAFLD to enable a sustainable ≥10%, weight loss, which can improve liver health, cardiovascular risk, and quality of life in those completing the intervention.",2020,"For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
","['Patients With Nonalcoholic Fatty Liver Disease', 'patients with clinically significant NAFLD', 'A total of 45 patients were approached of which 30 were enrolled 27 (90%) completed the VLCD intervention, and 20 (67%) were retained at 9-month follow-up', 'Patients with clinically significant NAFLD']","['VLCD', 'low calorie diet (VLCD', 'Very Low Calorie Diet', 'VLCD (∼800 kcal/d) intervention using meal replacement products']","['weight loss', 'VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition', 'Anthropometrics, blood tests (liver and metabolic), liver stiffness, and cardiovascular disease risk', 'liver health, cardiovascular risk, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",45.0,0.0206811,"For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
","[{'ForeName': 'Jadine', 'Initials': 'J', 'LastName': 'Scragg', 'Affiliation': '1Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; 2Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom; 3School of Health & Life Sciences, Teesside University, Tees Valley, United Kingdom; 4Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; 5Liver Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Avery', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cassidy', 'Affiliation': ''}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Haigh', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Trenell', 'Affiliation': ''}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hallsworth', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000231']
1635,33094958,Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial.,"INTRODUCTION


We investigated to compare the effect of empirical therapy vs clarithromycin resistance-guided tailored therapy (tailored therapy) for eradication of Helicobacter pylori.
METHODS


In this prospective, single center, open-label randomized controlled trial, we enrolled 72 patients with H. pylori infection from January 2019 through June 2019 in Korea. The patients were randomly assigned to both groups received empirical (n = 36) or tailored therapy (n = 36). Empirical therapy was defined as triple therapy with esomeprazole, amoxicillin, and clarithromycin for 10 days irrespective of clarithromycin resistance. Tailored therapy was triple or quadruple therapy with esomeprazole, metronidazole, tetracycline, and bismuth for 10 days based on genotype markers of resistance determined by gastric biopsy. Resistance-associated mutations in 23S rRNA were confirmed by multiplex polymerase chain reaction. Eradication status was assessed by C-urea breath test, and the primary outcome was eradication rates.
RESULTS


H. pylori was eradicated in 27 patients (75.0%), given empirical therapy and 32 patients (88.9%) treated with tailored therapy (P = 0.136) in intention-to-treat analysis. In per protocol analysis, the eradication rate was 97.0% and 81.8% in tailoredvs empirical groups (P = 0.046). Although clarithromycin-resistant H. pylori was eradicated in 3/9 (33.3%) with empirical therapy, it was treated in 11/12 (91.7%) with tailored therapy (P = 0.009). There was no difference in compliance between 2 groups. The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
DISCUSSION


Tailored therapy based on polymerase chain reaction is a good alternative to increase eradication rates in a region of high prevalence of clarithromycin resistance (see Visual Abstract, Supplementary Digital Content 1, http://links.lww.com/CTG/A342).",2020,"The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
","['72 patients with H. pylori infection from January 2019 through June 2019 in Korea', 'Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma']","['tailored therapy', 'clarithromycin resistance-guided tailored therapy (tailored therapy', 'esomeprazole, amoxicillin, and clarithromycin', 'Clarithromycin Resistance-Guided Therapy', 'clarithromycin', 'esomeprazole, metronidazole, tetracycline, and bismuth']","['eradication rates', 'eradication rate', 'Eradication status', 'side effects', 'rate of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024296', 'cui_str': 'Lymphatic tissue'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.0514967,"The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
","[{'ForeName': 'Jue Lie', 'Initials': 'JL', 'LastName': 'Kim', 'Affiliation': '1Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea; 2Department of Internal Medicine, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Ayoung', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jinju', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Sang Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000194']
1636,33094961,A Preclinical Animal Study of Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner for Obesity and Metabolic Disease.,"INTRODUCTION


Endoscopic bariatric and metabolic therapies can potentially reproduce similar gastric and small intestinal anatomic and physiologic manipulations as Roux-en-Y gastric bypass. This proof of concept animal study was aimed to assess the feasibility, safety, efficacy, and impact on gastrointestinal physiology of combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL) for the treatment of obesity.
METHODS


Five Ossabaw pigs were fed a high-calorie diet to develop obesity and were randomly assigned to receive IGB or DJBL in sequence. The weight gain rate was calculated. Fasting and postprandial blood samples were drawn before any intervention (serving as the baseline group) and 1 month after second device insertion (serving as the combination group) to measure gut neurohormonal changes and metabolic parameters.
RESULTS


Four pigs successfully received a sequential device insertion. One pig developed duodenal sleeve prolapse that was spontaneously resolved. One pig was early terminated because of developing a central line infection. The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone. A trend of higher postprandial glucagon-like peptide-1 was observed in the combination group compared with the baseline group.
DISCUSSION


A combination of IGB and DJBL is feasible and well tolerated. A strategy of sequential use of these devices might offer a synergistic approach that can enhance weight loss and metabolic outcomes.",2020,The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone.,['Five Ossabaw pigs were fed a high-calorie diet to develop obesity'],"['combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL', 'IGB or DJBL', 'Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner', 'sequential device insertion', 'IGB and DJBL']","['weight gain rate', 'duodenal sleeve prolapse', 'rate of weight gain', 'feasibility, safety, efficacy', 'Fasting and postprandial blood samples', 'higher postprandial glucagon-like peptide-1', 'weight loss and metabolic outcomes']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0301590', 'cui_str': 'Increased calorie diet'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C3880361', 'cui_str': 'Duodenal-jejunal bypass liner'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0340945,The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone.,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ghoz', 'Affiliation': '1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester Minnesota, USA; 2Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Veeravich', 'Initials': 'V', 'LastName': 'Jaruvongvanich', 'Affiliation': ''}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Matar', 'Affiliation': ''}, {'ForeName': 'Azizullah', 'Initials': 'A', 'LastName': 'Beran', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Maselli', 'Affiliation': ''}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Storm', 'Affiliation': ''}, {'ForeName': 'Barham K', 'Initials': 'BK', 'LastName': 'Abu Dayyeh', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000234']
1637,33095777,Perceived facilitators and barriers among physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only in patients eligible for knee replacement: A qualitative interview study nested in the QUADX-1 trial.,"AIM


Clinical guidelines recommend non-surgical treatment before surgery is considered in patients eligible for knee replacement. Surgical treatment is provided by orthopedic surgeons and exercise therapy is provided by physical therapists. The aim of this study was to identify perceived facilitators and barriers-among orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment of patients eligible for knee replacement using pre-operative home-based exercise therapy with one exercise.
METHODS


This qualitative study is embedded within the QUADX-1 randomized trial that investigates a model of coordinated non-surgical and surgical treatment for patients eligible for knee replacement. Physical therapists and orthopedic surgeons working with patients with knee osteoarthritis in their daily clinical work were interviewed (one focus group and four single interviews) to explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only in patients eligible for knee replacement. Interviews were analyzed using thematic analysis.
RESULTS


From the thematic analysis three main themes emerged: 1) Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care.
CONCLUSION


We found that the pre-operative exercise intervention created ambivalence in the professional role of both the physical therapists and orthopedic surgeons. The physical therapists were skeptical towards over-simplified exercise therapy. The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement. The consequence of these barriers and ambivalence in the professional role is important to consider when planning implementation of the model of coordinated non-surgical and surgical treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02931058.",2020,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"['patients eligible for', 'patients eligible for knee replacement', 'patients with knee osteoarthritis in their daily clinical work']","['explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only', 'physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only', 'orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment', ""Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care"", 'Physical therapists', 'knee replacement using pre-operative home-based exercise therapy with one exercise', 'exercise therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0574234,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"[{'ForeName': 'Rasmus Skov', 'Initials': 'RS', 'LastName': 'Husted', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre (CORH), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Kirk', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}]",PloS one,['10.1371/journal.pone.0241175']
1638,33095798,A cluster feasibility trial to explore the uptake and use of e-cigarettes versus usual care offered to smokers attending homeless centres in Great Britain.,"Smoking rates in the UK are at an all-time low but this masks considerable inequalities; prevalence amongst adults who are homeless remains four times higher than the national average. The objective of this trial was to assess the feasibility of supplying free e-cigarette starter kits to smokers accessing homeless centres and to estimate parameters to inform a possible future larger trial. In this feasibility cluster trial, four homeless centres in Great Britain were non-randomly allocated to either a Usual Care (UC) or E-Cigarette (EC) arm. Smokers attending the centres were recruited by staff. UC arm participants (N = 32) received advice to quit and signposting to the local Stop Smoking Service. EC arm participants (N = 48) received an EC starter kit and 4-weeks supply of e-liquid. Outcome measures were recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation. Eighty (mean age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks. The EC intervention was well received with minimal negative effects and very few unintended consequences (e.g. lost, theft, adding illicit substances). In both study arm, depression and anxiety scores declined over the duration of the study. Substance dependence scores remained constant. Assuming those with missing follow up data were smoking, CO validated sustained abstinence at 24 weeks was 3/48 (6.25%) and 0/32 (0%) respectively for the EC and UC arms. Almost all participants present at follow-up visits completed data collection for healthcare service and health-related quality of life measures. Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.",2020,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"['Smokers attending the centres were recruited by staff', 'smokers accessing homeless centres', 'smokers attending homeless centres in Great Britain', 'age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks', 'Eighty (mean', 'four homeless centres in Great Britain']","['advice to quit and signposting to the local Stop Smoking Service', 'Usual Care (UC) or E-Cigarette (EC', 'EC', 'supplying free e-cigarette starter kits', 'e-cigarettes versus usual care', 'EC starter kit and 4-weeks supply of e-liquid']","['recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation', 'Smoking rates', 'depression and anxiety scores', 'Substance dependence scores']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}]",153.0,0.0773539,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute and SPECTRUM Consortium, Old Medical School, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Robson', 'Affiliation': ""National Addiction Centre and SPECTRUM Consortium, Addictions Department & ARC South London, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, England.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, England.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Uny', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}]",PloS one,['10.1371/journal.pone.0240968']
1639,33095817,The effect of metacognitive training on confidence and strategic reminder setting.,"Individuals often choose between remembering information using their own memory ability versus using external resources to reduce cognitive demand (i.e. 'cognitive offloading'). For example, to remember a future appointment an individual could choose to set a smartphone reminder or depend on their unaided memory ability. Previous studies investigating strategic reminder setting found that participants set more reminders than would be optimal, and this bias towards reminder-setting was predicted by metacognitive underconfidence in unaided memory ability. Due to the link between underconfidence in memory ability and excessive reminder setting, the aim of the current study was to investigate whether metacognitive training is an effective intervention to a) improve metacognitive judgment accuracy, and b) reduce bias in strategic offloading behaviour. Participants either received metacognitive training which involved making performance predictions and receiving feedback on judgment accuracy, or were part of a control group. As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias. However, contrary to predictions, both experimental and control groups were significantly biased toward reminder-setting, and did not differ significantly. Therefore, reducing metacognitive bias was not sufficient to eliminate the bias towards reminders. We suggest that the reminder bias likely results in part from erroneous metacognitive evaluations, but that other factors such as a preference to avoid cognitive effort may also be relevant. Finding interventions to mitigate these factors could improve the adaptive use of external resources.",2020,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.",[],['metacognitive training'],"['metacognitive training increased judgment accuracy', 'metacognitive bias']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.0170334,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.","[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Engeler', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Gilbert', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0240858']
1640,33095849,Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial.,"Importance


Although current guidelines suggest the use of regional citrate anticoagulation (which involves the addition of a citrate solution to the blood before the filter of the extracorporeal dialysis circuit) as first-line treatment for continuous kidney replacement therapy in critically ill patients, the evidence for this recommendation is based on few clinical trials and meta-analyses.
Objective


To determine the effect of regional citrate anticoagulation, compared with systemic heparin anticoagulation, on filter life span and mortality.
Design, Setting, and Participants


A parallel-group, randomized multicenter clinical trial in 26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020). The trial was terminated early after 596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled.
Interventions


Patients were randomized to receive either regional citrate anticoagulation (n = 300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation (n = 296), which consisted of a target activated partial thromboplastin time of 45 to 60 seconds, for continuous kidney replacement therapy.
Main Outcomes and Measures


Coprimary outcomes were filter life span and 90-day mortality. Secondary end points included bleeding complications and new infections.
Results


Among 638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial. In the regional citrate group vs systemic heparin group, median filter life span was 47 hours (interquartile range [IQR], 19-70 hours) vs 26 hours (IQR, 12-51 hours) (difference, 15 hours [95% CI, 11 to 20 hours]; P < .001). Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91 [95% CI, 0.72 to 1.13]; unadjusted P = .38; adjusted difference, -6.1% [95% CI, -12.6% to 0.4%]; primary adjusted hazard ratio, 0.79 [95% CI, 0.63 to 1.004]; primary adjusted P = .054). Of 38 prespecified secondary end points, 34 showed no significant difference. Compared with the systemic heparin group, the regional citrate group had significantly fewer bleeding complications (15/300 [5.1%] vs 49/296 [16.9%]; difference, -11.8% [95% CI, -16.8% to -6.8%]; P < .001) and significantly more new infections (204/300 [68.0%] vs 164/296 [55.4%]; difference, 12.6% [95% CI, 4.9% to 20.3%]; P = .002).
Conclusions and Relevance


Among critically ill patients with acute kidney injury receiving continuous kidney replacement therapy, anticoagulation with regional citrate, compared with systemic heparin anticoagulation, resulted in significantly longer filter life span. The trial was terminated early and was therefore underpowered to reach conclusions about the effect of anticoagulation strategy on mortality.
Trial Registration


ClinicalTrials.gov Identifier: NCT02669589.",2020,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","['Critically Ill Patients With Acute Kidney Injury', '26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020', '638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial', 'critically ill patients with acute kidney injury receiving', 'critically ill patients', '596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled']","['systemic heparin', 'regional citrate anticoagulation (n\u2009=\u2009300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation', 'continuous kidney replacement therapy, anticoagulation with regional citrate', 'systemic heparin anticoagulation', 'regional citrate anticoagulation', 'continuous kidney replacement therapy', 'Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation']","['bleeding complications and new infections', 'cause mortality', 'bleeding complications', 'filter life span and mortality', 'longer filter life span', 'median filter life span', 'Dialysis Filter Life Span and Mortality', 'mortality', 'filter life span and 90-day mortality', 'new infections']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",638.0,0.468136,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Kindgen-Milles', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brandenburger', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dimski', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Tyczynski', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jahn', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Mülling', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mehrländer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Tim Philipp', 'Initials': 'TP', 'LastName': 'Simon', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaschinski', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Deetjen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Jens-Christian', 'Initials': 'JC', 'LastName': 'Schewe', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Slowinski', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bodenstein', 'Affiliation': 'Universitätsmedizin Mainz, Department of Anesthesiology, Mainz, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wirtz', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Helios Klinikum Bad Saarow, Bad Saarow, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kortgen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.18618']
1641,33096333,Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.,"BACKGROUND


Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.
METHODS


This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.
RESULTS


A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.
LIMITATIONS


Results are limited to green professions and representativeness might be restricted by self-selection of participants.
CONCLUSION


Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.
TRIAL REGISTRATION


German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.",2020,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","['green professions (PROD-A', 'Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5', 'Major Depressive Disorder (MDD']","['guided internet-based interventions', 'tailored internet-based intervention (IMI) program']","['stress, insomnia, panic and agoraphobia and harmful alcohol consumption', 'risk of potential MDD', 'depressive symptom severity (QIDS-SR16', 'depression reduction']","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.107642,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. Electronic address: lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany; Department of Research Methods, Institute of Psychology and Education, University of Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany; Department of Clinical, Neuro- & Developmental Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.066']
1642,33096356,"Adjunct high-frequency transcranial random noise stimulation over the lateral prefrontal cortex improves negative symptoms of schizophrenia: A randomized, double-blind, sham-controlled pilot study.","High-frequency transcranial random noise stimulation (hf-tRNS) is a non-invasive neuromodulatory technique capable of increasing human cortex excitability. There were only published case reports on the use of hf-tRNS targeting the lateral prefrontal cortex in treating negative symptoms of schizophrenia, thus necessitating systematic investigation. We designed a randomized, double-blind, sham-controlled trial in a cohort of stabilized schizophrenia patients to examine the efficacy of add-on hf-tRNS (100-640 Hz; 2 mA; 20 min) using a high definition 4 × 1 electrode montage (anode AF3, cathodes AF4, F2, F6, and FC4) in treating negative symptoms (ClinicalTrials.gov ID: NCT04038788). Participants received either active hf-tRNS or sham twice daily for 5 consecutive weekdays. Primary outcome measure was the change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS), which was measured at baseline, after 10-session stimulation, and at one-week and one-month follow-ups. Among 36 randomized patients, 35 (97.2%) completed the trial. Intention-to-treat analysis showed a significantly greater decrease in PANSS-FSNS score after active (-17.11%) than after sham stimulation (-1.68%), with a large effect size (Cohen's d = 2.16, p < 0.001). The beneficial effect lasted for up to one month. In secondary-outcome analyses, the authors observed improvements with hf-tRNS of disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms. No effects were observed on the neurocognitive performance and other outcome measures. Overall, hf-tRNS was safe and efficacious in improving negative symptoms. Our promising findings should be confirmed in a larger sample of patients with predominant negative symptoms.",2020,No effects were observed on the neurocognitive performance and other outcome measures.,"['stabilized schizophrenia patients', '36 randomized patients, 35 (97.2%) completed the trial', 'schizophrenia']","['High-frequency transcranial random noise stimulation (hf-tRNS', 'Adjunct high-frequency transcranial random noise stimulation', 'active hf-tRNS']","['PANSS-FSNS score', 'disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms', 'change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS', 'neurocognitive performance']","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517910', 'cui_str': '97.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",36.0,0.528973,No effects were observed on the neurocognitive performance and other outcome measures.,"[{'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yen-Yue', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Emergency Medicine, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan; Department of Life Sciences, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Psychiatry, Tri-Service General Hospital Songshan Branch, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: chang.ha@mail.ndmctsgh.edu.tw.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.008']
1643,33096362,Simulation strategies to increase nursing student clinical competence in safe medication administration practices: A quasi-experimental study.,"BACKGROUND


Nursing student medication errors often result from deficits in knowledge and application of fundamental safe administration practices. Factors such as high faculty-student ratios and legal restrictions have decreased clinical learning opportunities for nursing students to practice safe medication administration in the clinical setting. Evidence suggests that use of a structured medication safety enhancement (MSE) simulation program can significantly improve student knowledge and competency in safe medication administration.
PURPOSE


To examine the effects of an educational strategy using a MSE simulation program with integrated technology on the medication administration knowledge, competency, and confidence levels of undergraduate nursing students.
METHODS


This quasi-experimental replication study designed and implemented medication simulations enhanced by integrated information technologies in an undergraduate-nursing curriculum. Third-year BSN students (n = 83) were randomized into intervention or control groups. Control groups participated in standard training while the intervention group received additional clinical simulation experience and debriefing sessions focused on medication safety practices. Participant knowledge was measured using pre/post Medication Safety Knowledge Assessment (MSKA) and competency was evaluated using the Medication Safety Critical Element Checklist (MSCEC).
RESULTS


The MSKA and MSCEC were analyzed using two-sided independent t-tests. Post-test knowledge scores increased in both groups but results were not statistically significant (α = 0. 05). Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
CONCLUSION


Findings suggest that educators should consider high fidelity simulation as an evidence-based teaching strategy to engage students in understanding and implementing medication safety practices in the clinical setting.",2020,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","['undergraduate-nursing curriculum', 'Third-year BSN students (n\xa0=\xa083', 'undergraduate nursing students']",['standard training while the intervention group received additional clinical simulation experience and debriefing sessions'],"['Post-test knowledge scores', 'Medication Safety Critical Element Checklist (MSCEC']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",83.0,0.0131788,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Craig', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: sjw5y@virginia.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kastello', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: jck9e@virginia.edu.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Cieslowski', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: bjc6h@virginia.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Rovnyak', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA.'}]",Nurse education today,['10.1016/j.nedt.2020.104605']
1644,33096392,Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: A propensity score analysis.,"INTRODUCTION


In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
OBJECTIVE


To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
STUDY DESIGN


Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25 +0  and 33 +6  weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery.
RESULTS


153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13-1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03-0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
CONCLUSION


In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.",2020,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","['women with threatened preterm birth with ruptured membranes', 'women with singleton or twin pregnancies and a gestational age between 25 +0  and 33 +6  weeks', 'women with threatened preterm birth and ruptured membranes', 'All women had ruptured membranes', '153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort', 'Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin', '46 women who received tocolysis and 46 women who received', 'women with threatened preterm birth']","['Tocolysis', 'tocolysis with no tocolysis', 'nifedipine', 'no tocolysis']","['sepsis, gestational age at delivery and time to delivery', 'neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery', 'neonatal composite outcome', 'NICU admission', 'composite adverse neonatal outcome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]","[{'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",153.0,0.295046,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","[{'ForeName': 'T M S', 'Initials': 'TMS', 'LastName': 'van Winden', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'T A J', 'Initials': 'TAJ', 'LastName': 'Nijman', 'Affiliation': 'Leiden University Medical Centre, Department of Obstetrics and Gynecology, Leiden, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Olaru', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands. Electronic address: m.a.oudijk@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.015']
1645,33105381,Effects of 2 Types of Activation Protocols Based on Postactivation Potentiation on 50-m Freestyle Performance.,"Cuenca-Fernández, F, Ruiz-Teba, A, López-Contreras, G, and Arellano, R. Effects of 2 types of activation protocols based on postactivation potentiation on 50-m freestyle performance. J Strength Cond Res 34(11): 3284-3292, 2020-Postactivation potentiation (PAP) is a phenomenon which improves muscle contractility, strength, and speed in sporting performances through previously applied maximal or submaximal loads on the muscle system. This study aimed to assess the effects of 2 types of activation protocols based on PAP, on sprint swimming performance. A repeated-measures design was used to compare 3 different scenarios before a 50-m race. First, all of the participants performed a standard warm-up (SWU), consisting of a 400-m swim followed by dynamic stretching. This protocol acted as the control. Subsequently, the swimmers were randomly assigned into 2 groups: the swimmers in the first group performed the SWU followed by a PAP one-repetition maximum warm-up (RMWU), consisting of 3 ""lunge"" and 3 ""arm stroke"" repetitions, both at 85% of the one-repetition maximum. The swimmers in the second group performed the SWU followed by a PAP eccentric flywheel warm-up (EWU), consisting of one set of 4 repetitions of exercises of both the lower and upper limbs on an adapted eccentric flywheel at the maximal voluntary contraction. The time required for the swimmers to swim 5 and 10 m was shorter with the PAP protocols. The swimming velocity of the swimmers who underwent the EWU and RMWU protocols was faster at 5 and 10 m. The best total swimming time was not influenced by any of the protocols. When isolating swimming (excluding start performance and turn), best time was achieved with the SWU and RMWU compared with EWU (SWU: 20.86 ± 0.95 seconds; EWU: 21.25 ± 1.12 seconds; RMWU: 20.97 ± 1.22 seconds). In conclusion, a warm-up based on PAP protocols might exert an influence on performance in the first meters of a 50-m race. Nevertheless, other factors, such as fatigue, could modify swimming patterns and yield results contradictory to those of the desired task.",2020,The swimming velocity of the swimmers who underwent the EWU and RMWU protocols was faster at 5 and 10 m.,['J Strength Cond Res 34(11'],"['SWU followed by a PAP one-repetition maximum warm-up (RMWU', 'standard warm-up (SWU), consisting of a 400-m swim followed by dynamic stretching', 'SWU followed by a PAP eccentric flywheel warm-up (EWU), consisting of one set of 4 repetitions of exercises of both the lower and upper limbs on an adapted eccentric flywheel at the maximal voluntary contraction']","['muscle contractility, strength, and speed in sporting performances', 'total swimming time', 'sprint swimming performance']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0171391,The swimming velocity of the swimmers who underwent the EWU and RMWU protocols was faster at 5 and 10 m.,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cuenca-Fernández', 'Affiliation': 'Physical Activity and Sports Department, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Teba', 'Affiliation': ''}, {'ForeName': 'Gracia', 'Initials': 'G', 'LastName': 'López-Contreras', 'Affiliation': ''}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Arellano', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002698']
1646,33105387,Daily Step Count and Postprandial Fat Metabolism.,"INTRODUCTION


Two benefits of acute exercise are the next day's lowering of the postprandial plasma triglyceride response to a high fat meal and increased fat oxidation. However, if activity levels (daily steps) are very low, these acute adaptations to exercise don't occur. This phenomenon has been termed 'exercise resistance'. This study sought to systematically reduce daily step number and identify the range of step counts that elicit 'exercise resistance'.
METHODS


Ten participants completed three, five-day trials in a randomized, crossover design with differing levels of step reduction. Following two days of controlled activity, participants completed two days of LOW, LIMITED, or NORMAL steps (2,675 ± 314, 4,759 ± 276, and 8,481 ± 581 steps/day, respectively). Participants completed a 1-hour bout of running on the evening of the second day. High fat tolerance tests were performed on the following morning and postprandial responses were compared.
RESULTS


Following LOW and LIMITED, postprandial incremental area under the curve (AUC) of plasma triglyceride were elevated 22-23%, compared to NORMAL (p<0.05). Whole body fat oxidation was also significantly lower (16-19%, p<0.05, respectively) in LOW and LIMITED, compared to NORMAL. No significant differences were found between LOW and LIMITED.
CONCLUSION


Two days of step reduction to approximately 2,500-5,000 steps/day in young healthy individuals impairs the ability of an acute bout of exercise to increase fat oxidation and attenuate postprandial increases in plasma triglycerides. This suggests 'exercise resistance' occurs in individuals taking approximately 5,000 or fewer steps/day while 8,500 steps/day protects against exercise resistance in fat metabolism. It appears that fat metabolism is influenced more by the inhibitory effects of inactivity than by the stimulating effects derived from 1-hour of moderate intensity running.",2020,"Whole body fat oxidation was also significantly lower (16-19%, p<0.05, respectively) in LOW and LIMITED, compared to NORMAL.",['young healthy individuals'],[],"['fat oxidation and attenuate postprandial increases in plasma triglycerides', 'postprandial plasma triglyceride response', 'postprandial incremental area under the curve (AUC) of plasma triglyceride', 'Daily Step Count and Postprandial Fat Metabolism', 'Whole body fat oxidation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",10.0,0.0703125,"Whole body fat oxidation was also significantly lower (16-19%, p<0.05, respectively) in LOW and LIMITED, compared to NORMAL.","[{'ForeName': 'Heath M', 'Initials': 'HM', 'LastName': 'Burton', 'Affiliation': 'Human Performance Laboratory, Department of Kinesiology and Health Education, University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Coyle', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002486']
1647,33105390,Blood Flow Restriction Combined with Electrical Stimulation Attenuates Thigh Muscle Disuse Atrophy.,"PURPOSE


To investigate the effects of blood flow restriction (BFR) combined with electrical muscle stimulation (EMS) on skeletal muscle mass and strength during a period of limb disuse.
METHODS


Thirty healthy participants (22 ± 3 years; 23 ± 3 kg·m) were randomly assigned to either: control (CON; n=10), BFR alone (BFR; n=10), or BFR combined with EMS (BFR+EMS; n=10). All participants completed unloading of a single-leg for 14-days, with no treatment (CON), or while treated with either BFR, or BFR+EMS (twice daily, 5 day/week). BFR treatment involved arterial 3 cycles of 5 min occlusion using suprasystolic pressure, each separated by 5-min of reperfusion. EMS (6s on, 15s off; 200 μs; 60Hz; 15 % MVC) was applied continuously throughout the 3 BFR cycles. Quadriceps muscle mass (whole thigh lean mass via DEXA and Vastus Lateralis (VL) muscle thickness via ultrasound) and strength (via knee-extension maximal voluntary contraction (MVC)) were assessed before and after the 14-day unloading period.
RESULTS


Following limb unloading, whole thigh lean mass decreased in the control (-4 ± 1%; p < 0.001) and BFR group (-3 ± 2%; p = 0.001), but not in the BFR+EMS group (-0.3 ± 3%; p = 0.8). VL muscle thickness decreased in the control group (-4 ± 4%; p = 0.005), and was trending toward a decrease in the BFR group (-8 ± 11%; p = 0.07) and increase in the BFR+EMS group (+5 ± 10%; p = 0.07). Knee-extension MVC decreased over time (p < 0.005) in the control (-18 ± 15%), BFR group (-10 ± 13%), and BFR+EMS (-18 ± 15%) group, with no difference between groups (p > 0.5).
CONCLUSION


Unlike BFR performed in isolation, BFR+EMS represents an effective interventional strategy to attenuate the loss of muscle mass during limb disuse, but it does not demonstrate preservation of strength.",2020,"VL muscle thickness decreased in the control group (-4 ± 4%; p = 0.005), and was trending toward a decrease in the BFR group (-8 ± 11%; p = 0.07) and increase in the BFR+EMS group (+5 ± 10%; p = 0.07).",['Thirty healthy participants (22 ± 3 years; 23 ± 3 kg·m'],"['no treatment (CON), or while treated with either BFR, or BFR+EMS', 'blood flow restriction (BFR) combined with electrical muscle stimulation (EMS', 'BFR combined with EMS (BFR+EMS', 'BFR alone', 'Blood Flow Restriction Combined with Electrical Stimulation']","['Quadriceps muscle mass (whole thigh lean mass via DEXA and Vastus Lateralis (VL) muscle thickness via ultrasound) and strength (via knee-extension maximal voluntary contraction (MVC', 'Knee-extension MVC', 'skeletal muscle mass and strength', 'VL muscle thickness', 'thigh lean mass']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",30.0,0.0235988,"VL muscle thickness decreased in the control group (-4 ± 4%; p = 0.005), and was trending toward a decrease in the BFR group (-8 ± 11%; p = 0.07) and increase in the BFR+EMS group (+5 ± 10%; p = 0.07).","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Slysz', 'Affiliation': 'The University of Guelph, Guelph Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boston', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pignanelli', 'Affiliation': ''}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002544']
1648,33105394,Reduction in stigma drivers partially mediates the effect of a stigma reduction intervention among nursing students in India: The DriSti cluster randomized controlled trial.,"BACKGROUND


HIV stigma in health care settings acts as a significant barrier to health care. Stigma drivers among health professionals include transmission fears and misconceptions and pre-existing negative attitudes towards marginalized groups vulnerable to HIV. The DriSti intervention, consisted of two sessions with videos and interactive exercises on a computer tablet and one interactive skills-based face-to-face group session, mostly tablet administered, was designed to target key stigma drivers that included instrumental stigma, symbolic stigma, transmission misconceptions and blame to reduce HIV stigma and discrimination among nursing students and ward staff and tested in a cluster randomized trial.
SETTING


This report focuses on second and third year nursing students (NS) recruited from a range of nursing schools that included private, non-profit, and government- run nursing schools from south India.
RESULTS


Six hundred seventy nine NS received intervention and 813 NS were in the wait-list control group. Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (p<.001) and in the number of situations in which NS intended to discriminate against PLWH (p<.001). Mediation analysis revealed that the effects of intervention on endorsement of coercive policies and intent to discriminate against PLWH were partially mediated by reductions in key stigma drivers that included instrumental stigma, blame, symbolic stigma and transmission misconceptions.
CONCLUSION


This brief scalable stigma reduction intervention targeting key stigma drivers fills a critical gap in identifying the mechanistic pathways that aid in stigma reduction among health professionals.",2020,Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (p<.001) and in the number of situations in which NS intended to discriminate against PLWH (p<.001).,"['second and third year nursing students (NS) recruited from a range of nursing schools that included private, non-profit, and government- run nursing schools from south India', 'Six hundred seventy nine NS', 'nursing students in India']","['videos and interactive exercises on a computer tablet and one interactive skills-based face-to-face group session, mostly tablet administered, was designed to target key stigma drivers that included instrumental stigma, symbolic stigma, transmission misconceptions and blame to reduce HIV stigma and discrimination among nursing students and ward staff', 'stigma reduction intervention']",[],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0029247', 'cui_str': 'Non-profit organization'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0505196,Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (p<.001) and in the number of situations in which NS intended to discriminate against PLWH (p<.001).,"[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute and St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Raj', 'Affiliation': ""Division of Medical Informatics, St John's Research Institute, and St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nyblade', 'Affiliation': 'Global Health Division, International Development Group, RTI International, USA.'}, {'ForeName': 'Dhinagaran', 'Initials': 'D', 'LastName': 'Devadass', 'Affiliation': ""Division of Medical Informatics, St John's Research Institute, and St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, USA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002543']
1649,33109190,Efficacy of the 'Stand and Move at Work' multicomponent workplace intervention to reduce sedentary time and improve cardiometabolic risk: a group randomized clinical trial.,"BACKGROUND


Sedentary time is associated with chronic disease and premature mortality. We tested a multilevel workplace intervention with and without sit-stand workstations to reduce sedentary time and lower cardiometabolic risk.
METHODS


Stand and Move at Work was a group (cluster) randomized trial conducted between January 2016 and December 2017 among full-time employees; ≥18 years; and in academic, industry/healthcare, and government worksites in Phoenix, Arizona and Minneapolis/St. Paul, Minnesota, USA. Eligible worksites were randomized to (a) MOVE+, a multilevel intervention targeting reduction in sedentary time and increases in light physical activity (LPA); or (b) STAND+, the MOVE+ intervention along with sit-stand workstations to allow employees to sit or stand while working. The primary endpoints were objectively-measured workplace sitting and LPA at 12 months. The secondary endpoint was a clustered cardiometabolic risk score (blood pressure, glucose, insulin, triglycerides, and HDL-cholesterol) at 12 months.
RESULTS


Worksites (N = 24; academic [n = 8], industry/healthcare [n = 8], and government [n = 8] sectors) and employees (N = 630; 27 ± 8 per worksite; 45 ± 11 years of age, 74% female) were enrolled. All worksites were retained and 487 participants completed the intervention and provided data for the primary endpoint. The adjusted between arm difference in sitting at 12 months was - 59.2 (CI: - 74.6,-43.8) min per 8 h workday, favoring STAND+, and in LPA at 12 months was + 2.2 (- 0.9,5.4) min per 8 h workday. Change in the clustered metabolic risk score was small and not statistically significant, but favored STAND+. In an exploratory subgroup of 95 participants with prediabetes or diabetes, the effect sizes were larger and clinically meaningful, all favoring STAND+, including blood glucose, triglycerides, systolic blood pressure, glycated hemoglobin, LDL-cholesterol, body weight, and body fat.
CONCLUSIONS


Multilevel workplace interventions that include the use of sit-stand workstations are effective for large reductions in sitting time over 12 months. Among those with prediabetes or diabetes, clinical improvements in cardiometabolic risk factors and body weight may be realized.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02566317 . Registered 2 October 2015, first participant enrolled 11 January 2016.",2020,"CONCLUSIONS


Multilevel workplace interventions that include the use of sit-stand workstations are effective for large reductions in sitting time over 12 months.","['Worksites (N\xa0=\u200924; academic [n\xa0', '95 participants with prediabetes or diabetes', '8], industry/healthcare [n\xa0=\u20098], and government [n\xa0', 'Stand and Move at Work was a group (cluster) randomized trial conducted between January 2016 and December 2017 among full-time employees; ≥18\u2009years; and in academic, industry/healthcare, and government worksites in Phoenix, Arizona and Minneapolis/St', '8] sectors) and employees (N\xa0=\u2009630; 27\u2009±\u20098 per worksite; 45\u2009±\u200911\u2009years of age, 74% female) were enrolled']","[""Stand and Move at Work' multicomponent workplace intervention"", 'multilevel workplace intervention with and without sit-stand workstations', 'MOVE+, a multilevel intervention targeting reduction in sedentary time and increases in light physical activity (LPA); or (b) STAND+, the MOVE+ intervention along with sit-stand workstations to allow employees to sit or stand while working']","['clustered cardiometabolic risk score (blood pressure, glucose, insulin, triglycerides, and HDL-cholesterol', 'sedentary time and improve cardiometabolic risk', 'objectively-measured workplace sitting and LPA', 'cardiometabolic risk factors and body weight', 'blood glucose, triglycerides, systolic blood pressure, glycated hemoglobin, LDL-cholesterol, body weight, and body fat', 'clustered metabolic risk score']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",95.0,0.102966,"CONCLUSIONS


Multilevel workplace interventions that include the use of sit-stand workstations are effective for large reductions in sitting time over 12 months.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pereira', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA. map@umn.edu.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mullane', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Meynard John Lapore', 'Initials': 'MJL', 'LastName': 'Toledo', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Larouche', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Rydell', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Vuong', 'Affiliation': 'Fairview Health Services, Minneapolis, MN, USA.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Feltes', 'Affiliation': 'Minnesota Department of Health, Minneapolis, MN, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Mitchell', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Junia N', 'Initials': 'JN', 'LastName': 'de Brito', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hasanaj', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Neil G', 'Initials': 'NG', 'LastName': 'Carlson', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Gaesser', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'University of Minnesota, School of Public Health, 1300 South Second Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'Arizona State University, College of Health Solutions, 500 North 3rd Street, Phoenix, AZ, 85004, USA. mbuman@asu.edu.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01033-3']
1650,33109218,The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects.,"BACKGROUND


Fabry disease is a rare inherited glycosphingolipid storage disorder caused by deleterious mutations in the GLA gene coding for the lysosomal enzyme α-galactosidase A. The glucosylceramide synthase inhibitor lucerastat is an iminosugar with potential to provide oral substrate reduction therapy in Fabry disease, regardless of the patient´s underlying mutation. Since lucerastat exhibits systemic exposure and many patients with Fabry disease suffer from rhythm and conduction abnormalities its effects on cardiac repolarization were evaluated in a thorough QT study.
METHODS


In Part A of this randomized, double-blind, placebo-controlled phase 1 study, single oral doses of 2000 and 4000 mg lucerastat were investigated to determine the supratherapeutic dose for Part B. The latter was a four-way crossover study to demonstrate that lucerastat at single oral therapeutic and supratherapeutic doses had no effect on the QTc interval > 10 ms using concentration-QTc modeling as primary analysis. The primary ECG endpoint was placebo-corrected change-from-baseline (ΔΔ) in Fridericia-corrected QTc (ΔΔQTcF). Open-label moxifloxacin served as positive control.
RESULTS


The effect of lucerastat on ΔΔQTcF was predicted as 0.39 ms (90% confidence interval [CI] - 0.13 to 0.90) and 1.69 ms (90% CI 0.33-3.05) at lucerastat peak plasma concentration after dosing with 1000 mg (5.2 µg/mL) and 4000 mg (24.3 µg/mL), respectively. A QTcF effect > 10 ms was excluded up to lucerastat plasma concentrations of approximately 34.0 µg/mL. Lucerastat did not exert an effect on other ECG parameters. Across doses, absorption of lucerastat was rapid, its elimination half-life ranged from 8.0 to 10.0 h, and the pharmacokinetics (PK) of lucerastat were dose-proportional. Moxifloxacin PK were in line with published data and assay sensitivity was demonstrated by the moxifloxacin QTc response. Lucerastat was safe and well tolerated.
CONCLUSIONS


Lucerastat up to a dose of 4000 mg has no clinically relevant liability to prolong the QT interval or any clinically relevant effect on other ECG parameters. This will be an important factor in the overall benefit-risk assessment of lucerastat in the potential treatment of Fabry disease. Trial registration The study was registered with the ClinicalTrials.gov identifier NCT03832452 (February 6th, 2019, https://clinicaltrials.gov/ct2/show/NCT03832452 ) and the EudraCT number 2018-004546-42 (December 17th, 2018).",2020,"CONCLUSIONS


Lucerastat up to a dose of 4000 mg has no clinically relevant liability to prolong the QT interval or any clinically relevant effect on other ECG parameters.","['number 2018-004546-42 (December 17th, 2018', 'healthy subjects']","['placebo', 'glucosylceramide synthase inhibitor lucerastat', 'Open-label moxifloxacin', 'Moxifloxacin PK', 'EudraCT']","['lucerastat plasma concentrations', 'ΔΔQTcF', 'placebo-corrected change-from-baseline (ΔΔ) in Fridericia-corrected QTc (ΔΔQTcF', 'safe and well tolerated', 'cardiac repolarization', 'lucerastat peak plasma concentration']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0163410', 'cui_str': 'Ceramide glucosyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.193165,"CONCLUSIONS


Lucerastat up to a dose of 4000 mg has no clinically relevant liability to prolong the QT interval or any clinically relevant effect on other ECG parameters.","[{'ForeName': 'Markus S', 'Initials': 'MS', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland. markus.mueller@idorsia.com.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Voors-Pette', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'eResearch Technology Inc, ERT, Rochester, NY, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'eResearch Technology Inc, ERT, Rochester, NY, USA.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01582-7']
1651,33109230,Self-managed medication abortion outcomes: results from a prospective pilot study.,"BACKGROUND


To evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person).
METHODS


In 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support. Participants completed up to five interview-administered questionnaires from baseline through 6-weeks after taking the pills. Primary outcomes included: (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications.
RESULTS


Over the 30-day recruitment period, we enrolled 227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit. At the 1-week follow-up, two participants (1%) reported a miscarriage prior to taking the pills, and 202 participants (89% of those enrolled and 99% of those who participated in the 1-week survey) had obtained and taken the medications. Three weeks after taking the medications, 192 (95%) participants reported feeling that their abortion was complete. Three (1.5%) received a surgical intervention, two (1%) received antibiotics, and five (3%) received other medications. Participants did not report any major adverse events.
CONCLUSION


These results establish the feasibility of conducting prospective studies of self-managed medication abortion in legally restrictive settings. Further, the high effectiveness of self-managed medication abortion with accompaniment support reported here is consistent with high levels of effectiveness reported in prior studies. Trial registration ISRCTN95769543.",2020,"Participants did not report any major adverse events.
","['In 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support', 'recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person', '227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit', 'legally restrictive settings']",['self-managed medication abortion'],"[' (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518532', 'cui_str': 'Does manage medication'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518532', 'cui_str': 'Does manage medication'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0233105', 'cui_str': 'Abortion complete'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",227.0,0.0591643,"Participants did not report any major adverse events.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Moseson', 'Affiliation': 'Ibis Reproductive Health, 1736 Franklin Street, Suite 600, Oakland, CA, 94612, USA. hmoseson@ibisreproductivehealth.org.'}, {'ForeName': 'Ruvani', 'Initials': 'R', 'LastName': 'Jayaweera', 'Affiliation': 'Ibis Reproductive Health, 1736 Franklin Street, Suite 600, Oakland, CA, 94612, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raifman', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Keefe-Oates', 'Affiliation': 'Ibis Reproductive Health, Cambridge, MA, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Filippa', 'Affiliation': 'Ibis Reproductive Health, 1736 Franklin Street, Suite 600, Oakland, CA, 94612, USA.'}, {'ForeName': 'Relebohile', 'Initials': 'R', 'LastName': 'Motana', 'Affiliation': 'Ibis Reproductive Health, Johannesburg, South Africa.'}, {'ForeName': 'Ijeoma', 'Initials': 'I', 'LastName': 'Egwuatu', 'Affiliation': 'Generation Initiative for Women and Youth, Lagos, Nigeria.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Grosso', 'Affiliation': 'La Revuelta Colectiva Feminista, Neuquén, Argentina.'}, {'ForeName': 'Ika', 'Initials': 'I', 'LastName': 'Kristianingrum', 'Affiliation': 'Samsara, Yogyakarta, Indonesia.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Nmezi', 'Affiliation': 'Generation Initiative for Women and Youth, Lagos, Nigeria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Zurbriggen', 'Affiliation': 'La Revuelta Colectiva Feminista, Neuquén, Argentina.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gerdts', 'Affiliation': 'Ibis Reproductive Health, 1736 Franklin Street, Suite 600, Oakland, CA, 94612, USA.'}]",Reproductive health,['10.1186/s12978-020-01016-4']
1652,33109233,Effect of body mass index on response to neo-adjuvant therapy in HER2-positive breast cancer: an exploratory analysis of the NeoALTTO trial.,"BACKGROUND


Obesity is a risk factor for breast cancer (BC) development, recurrence, and death. In view of this, we aimed to investigate the clinical value of obesity in BC patients treated with anti-HER2 therapies in the NeoALTTO trial, which randomized 455 patients to neo-adjuvant lapatinib, trastuzumab, or their combination plus paclitaxel.
METHODS


Patients were classified according to their basal body mass index (BMI) into underweight (< 18.5 kg/m 2 ), normal (≥ 18.5; < 25 kg/m 2 ), overweight (≥ 25; < 30 kg/m 2 ), and obese (≥ 30 kg/m 2 ) WHO categories. Univariate and multivariate logistic regression analyses were performed using BMI as a categorical variable. Pathological complete response (pCR) and event-free survival (EFS) were the NeoALTTO primary and secondary outcomes, respectively.
RESULTS


Among 454 patients analyzed, 14 (3%), 220 (48%), 137 (30%), and 83 (18%) were classified as underweight, normal weight, overweight, and obese, respectively; 231 (51%) and 223 (49%) had hormone receptor (HR)-positive and HR-negative primary tumors; 160 (35%) achieved pCR. In the overall patient population, no association was found between BMI groups and pCR, as we reported pCR rates of 57.1%, 35%, 30.7%, and 39.8% in underweight, normal weight, overweight, and obese cases, respectively. In contrast, in HR-positive tumors, overweight or obesity was generally associated with decreased likelihood of achieving a pCR independently of other clinical variables, including planned surgery, nodal status, and tumor size (odds ratio [OR] = 0.55, 95%CI 0.30-1.01, as compared to normal or underweight; p = 0.053); notably, no differential effect of BMI with respect to pCR was observed in HR-negative cases (odds ratio [OR] = 1.30, 95%CI 0.76-2.23, as compared to normal or underweight; p = 0.331), resulting in a statistically significant interaction between BMI and HR status (p = 0.036). There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
CONCLUSIONS


NeoALTTO patients overweight or obese at baseline and with HR-positive primary BC appeared less likely to achieve pCR after neo-adjuvant anti-HER2 therapies. This finding paves the way to future research in targeting the interplay between HER2/HR signaling and metabolism.",2020,"There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
","['Patients were classified according to their basal body mass index (BMI) into underweight (<\u200918.5\u2009kg/m 2 ), normal (≥\u200918.5; <\u200925\u2009kg/m 2 ), overweight (≥\u200925; <\u200930\u2009kg/m 2 ), and obese (≥\u200930\u2009kg/m 2 ) WHO categories', 'HER2-positive breast cancer', 'BC patients treated with', '455 patients to neo-adjuvant']","['anti-HER2 therapies', 'lapatinib, trastuzumab, or their combination plus paclitaxel', 'pCR', 'body mass index']","['planned surgery, nodal status, and tumor size', 'pCR', 'BMI and HR status', 'Pathological complete response (pCR) and event-free survival (EFS', 'BMI and EFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C3536735', 'cui_str': 'Basal Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",455.0,0.069468,"There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy. serena.dicosimo@istitutotumori.mi.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Porcu', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kincraig, UK.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'San Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Maria Alice', 'Initials': 'MA', 'LastName': 'Franzoi', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'De Santis', 'Affiliation': 'Radiation Oncology, Fondazione IRSCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group (BIG), Boulevard de Waterloo 76, 1000, Bruxelles, Belgium.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Oncology Clinical Development, Oncology Business Unit, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Daidone', 'Affiliation': 'Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}]",Breast cancer research : BCR,['10.1186/s13058-020-01356-w']
1653,33109252,"The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine.
TRIAL DESIGN


A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial.
PARTICIPANTS


Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded.
INTERVENTION AND COMPARATOR


Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days.
MAIN OUTCOMES


The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes.
RANDOMISATION


The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures.
BLINDING (MASKING)


This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm.
TRIAL STATUS


Protocol version 2.0 dated 16 th  May 2020. Recruitment is completed. The trial started recruitment on the 25 th  May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection TRIAL REGISTRATION: The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma.","['Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy', 'asymptomatic COVID-19 cases', '60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm', 'Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma', 'Protocol version 2.0 dated 16 th  May 2020', 'Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited']","['Siddha Medicine, Kabasura Kudineer (KSK', 'Vitamin C', 'Zinc tablets', 'Vitamin C & Zinc (CZ) supplementation', '60ml decoction', 'Vitamin C and Zinc (CZ) supplementation', 'Siddha medicine, Kabasura kudineer']","['prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha', 'reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0038191', 'cui_str': 'Government, State'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0259995', 'cui_str': 'Siddha Medicine'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}]",,0.425945,"Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Natarajan', 'Affiliation': 'Siddha Central Research Institute, Chennai, India. drnatarajan78@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anbarasi', 'Affiliation': 'Siddha Central Research Institute, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sathiyarajeswaran', 'Affiliation': 'Siddha Central Research Institute, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Manickam', 'Affiliation': 'ICMR-National Institute of Epidemiology, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Geetha', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kathiravan', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Prathiba', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pitchiahkumar', 'Affiliation': 'State Licensing Authority (Indian Medicine), Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Parthiban', 'Affiliation': 'Department of Indian Medicine and Homeopathy, Government of Tamil Nadu, Chennai, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kanakavalli', 'Affiliation': 'Central Council for Research in Siddha, Ministry of AYUSH, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Balaji', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}]",Trials,['10.1186/s13063-020-04823-z']
1654,33109254,Explaining the mixed findings of a randomised controlled trial of telehealth with centralised remote support for heart failure: multi-site qualitative study using the NASSS framework.,"BACKGROUND


The SUPPORT-HF2 randomised controlled trial compared telehealth technology alone with the same technology combined with centralised remote support, in which a clinician responds promptly to biomarker changes. The intervention was implemented differently in different sites; no overall impact was found on the primary endpoint (proportion of patients on optimum treatment). We sought to explain the trial's findings in a qualitative evaluation.
METHODS


Fifty-one people (25 patients, 3 carers, 18 clinicians, 4 additional researchers) were interviewed and observed in 7 UK trial sites in 2016-2018. We collected 110 pages of documents. The analysis was informed by the NASSS framework, a multi-level theoretical lens which considers non-adoption and abandonment of technologies by individuals and challenges to scale-up, spread and sustainability. In particular, we used NASSS to tease out why a 'standardised' socio-technical intervention played out differently in different sites.
RESULTS


Patients' experiences of the technology were largely positive, though influenced by the nature and severity of their illness. In each trial site, existing services, staffing levels, technical capacity and previous telehealth experiences influenced how the complex intervention of 'telehealth technology plus centralised specialist remote support' was interpreted and the extent to which it was adopted and used to its full potential. In some sites, the intervention was quickly mobilised to fill significant gaps in service provision. In others, it was seen as usefully extending the existing care model for selected patients. Elsewhere, the new model was actively resisted and the technology little used. In one site, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service.
CONCLUSIONS


Complex socio-technical interventions, even when implemented in a so-called standardised way with uniform inclusion and exclusion criteria, are inevitably implemented differently in different local settings because of how individual staff members interpret the technology and the trial protocol and because of the practical realities and path dependencies of local organisations. Site-specific iteration and embedding of a new technology-supported complex intervention may be required (in addition to co-design of the user interface) before such interventions are ready for testing in clinical trials.
TRIAL REGISTRATION


BMC ISRCTN Registry 86212709 . Retrospectively registered on 5 September 2014.",2020,"In one site, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service.
","['Fifty-one people (25 patients, 3 carers, 18 clinicians, 4 additional researchers) were interviewed and observed in 7 UK trial sites in 2016-2018', 'heart failure']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],[],,0.0607161,"In one site, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service.
","[{'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Papoutsi', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': ""A'Court"", 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wherton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shaw', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Greenhalgh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. trish.greenhalgh@phc.ox.ac.uk.'}]",Trials,['10.1186/s13063-020-04817-x']
1655,33109271,Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial.,"BACKGROUND


Suicide is a serious public health problem. The development and use of effective treatments for people hospitalized for suicide attempts remain a priority. Regarding psychosocial treatment, the evidence for treatments that effectively prevent suicide repetition of suicide attempts is extremely thin. There is some evidence that cognitive behavioural therapy may be effective for reducing suicide behaviour. The primary aim of this study is to compare Group Post-Admission Cognitive Therapy for Suicidality (GPACTS) versus Individual Supportive Therapy (IST) for preventing suicide.
METHODS


In total, 240 participants with a high suicide risk score according to a Mini International Neuropsychiatric Interview (MINI) will be randomized to either GPACTS or IST. This is a multicentre, parallel group, randomized (1:1 ratio), two-tailed-superiority trial with endpoint-assessor blinding. Patients meeting inclusion criteria during a screening visit will be enrolled in the study and randomized into two groups: one group will undergo 6 weeks of GPACTS, and the second group will undergo 6 weeks of IST. Following 6 weeks of interventional therapy, patients are followed up for 12 months. Follow-up for both groups is identical and includes the administration of questionnaires at baseline and then within 10 days after the end of therapy sessions and then at 3, 6 and 12 months following the end of GPACTS/IST sessions.
DISCUSSION


To our knowledge, this is the first RCT of its kind to be conducted in France, and so far, there are no studies in the literature on group psychotherapy for the treatment of individuals who have attempted suicide. The outcomes will provide clear guidance for professionals to apply psychological intervention with suicide attempts. The protocol respects ethical principles, and ethical approval was obtained from the local ethics committee. The results will be disseminated through an original research published as original research in peer-reviewed manuscript, through a therapist manual for cognitive therapy, and presentations at research conferences.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02664701 . Registered on January 27, 2017.",2020,"Follow-up for both groups is identical and includes the administration of questionnaires at baseline and then within 10 days after the end of therapy sessions and then at 3, 6 and 12 months following the end of GPACTS/IST sessions.
","['240 participants with a high suicide risk score according to a Mini International Neuropsychiatric Interview (MINI', 'individuals who have attempted suicide', 'Patients meeting inclusion criteria during a screening visit']","['GPACTS, and the second group will undergo 6\xa0weeks of IST', 'cognitive behavioural therapy', 'GPACTS or IST', 'Group Post-Admission Cognitive Therapy for Suicidality (GPACTS) versus Individual Supportive Therapy (IST', 'Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy']",[],"[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C1271074', 'cui_str': 'High suicide risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585046', 'cui_str': 'Post admission'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344211', 'cui_str': 'Support'}]",[],240.0,0.130742,"Follow-up for both groups is identical and includes the administration of questionnaires at baseline and then within 10 days after the end of therapy sessions and then at 3, 6 and 12 months following the end of GPACTS/IST sessions.
","[{'ForeName': 'Laurent S', 'Initials': 'LS', 'LastName': 'Chaïb', 'Affiliation': 'Department of Adult Psychiatry, University Hospital, Place du Pr. R. Debré, 30029, Nîmes, Cedex 9, France. laurent.chaib@chu-nimes.fr.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Lopez-Castroman', 'Affiliation': 'Department of Adult Psychiatry, University Hospital, Place du Pr. R. Debré, 30029, Nîmes, Cedex 9, France.'}, {'ForeName': 'Mocrane', 'Initials': 'M', 'LastName': 'Abbar', 'Affiliation': 'Department of Adult Psychiatry, University Hospital, Place du Pr. R. Debré, 30029, Nîmes, Cedex 9, France.'}]",Trials,['10.1186/s13063-020-04816-y']
1656,33109273,The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress-a randomized controlled study.,"BACKGROUND


Exercise training is suggested to have a stress-buffering effect on physiological reactions to acute stress. The so-called cross-stressor adaptation hypothesis is one of many theories behind the plausible effects, proposing that the attenuated physiological reaction seen in trained individuals in response to acute exercise is also seen when the individual is exposed to acute psychosocial stress. However, few randomized controlled trials (RCT) are available in this field. Therefore, the aim of the present trial was to study the effects of a 6-month aerobic exercise intervention on the physiological response to acute laboratory stress.
METHODS


A two-armed RCT including untrained but healthy individuals aged 20-50 years was conducted. Assessments included a peak oxygen uptake test and a psychosocial stress test (the Trier Social Stress Test). A total of 88 participants went through both baseline and follow-up measures (48 in the intervention group and 40 in the control group) with a similar proportion of women and men (20 women and 28 men in the intervention group and 18 women and 22 men in the control group). Outcome measures were adrenocorticotrophic hormone, cortisol, systolic and diastolic blood pressure, and heart rate responses to acute psychosocial stress.
RESULTS


Oxygen uptake and time-to-exhaustion increased significantly following the intervention, while a decrease was seen in the control group. The analyses showed attenuated responses to acute psychosocial stress for all variables in both groups at follow-up, with no differences between the groups. No correlation was seen between amount of exercise training and reactivity to the stress test. Despite the increased oxygen uptake in the intervention group, no differences were seen between the groups for any of the outcome variables at follow-up.
CONCLUSIONS


In this study, the cross-stressor adaptation hypothesis could not be confirmed. Both groups showed decreased reactions indicating a habituation to the stress test.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02051127 . Registered on 31 January 2014-retrospectively registered.",2020,"Despite the increased oxygen uptake in the intervention group, no differences were seen between the groups for any of the outcome variables at follow-up.
","['88 participants went through both baseline and follow-up measures (48 in the intervention group and 40 in the control group) with a similar proportion of women and men (20 women and 28 men in the intervention group and 18 women and 22 men in the control group', 'A two-armed RCT including untrained but healthy individuals aged 20-50\u2009years']","['Exercise training', 'exercise training', 'aerobic exercise intervention']","['hypothalamic-pituitary-adrenal axis reactivity and autonomic response', 'peak oxygen uptake test and a psychosocial stress test (the Trier Social Stress Test', 'acute psychosocial stress', 'Oxygen uptake and time-to-exhaustion', 'adrenocorticotrophic hormone, cortisol, systolic and diastolic blood pressure, and heart rate responses to acute psychosocial stress', 'oxygen uptake']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}]",88.0,0.0539345,"Despite the increased oxygen uptake in the intervention group, no differences were seen between the groups for any of the outcome variables at follow-up.
","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Arvidson', 'Affiliation': 'The Institute of Stress Medicine, Västra götalandsregionen, Gothenburg, Sweden. elin.arvidson@vgregion.se.'}, {'ForeName': 'Anna Sjörs', 'Initials': 'AS', 'LastName': 'Dahlman', 'Affiliation': 'The Institute of Stress Medicine, Västra götalandsregionen, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Börjesson', 'Affiliation': 'The Department of Food and Nutrition, and Sport Science, Faculty of Education, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Gullstrand', 'Affiliation': 'The Department of Food and Nutrition, and Sport Science, Faculty of Education, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ingibjörg H', 'Initials': 'IH', 'LastName': 'Jonsdottir', 'Affiliation': 'The Institute of Stress Medicine, Västra götalandsregionen, Gothenburg, Sweden.'}]",Trials,['10.1186/s13063-020-04803-3']
1657,33109288,Utility of Different Lung Ultrasound Simulation Modalities Used by Paramedics during Varied Ambulance Driving Conditions.,"INTRODUCTION


Prehospital use of lung ultrasound (LUS) by paramedics to guide the diagnoses and treatment of patients has expanded over the past several years. However, almost all of this education has occurred in a classroom or hospital setting. No published prehospital use of LUS simulation software within an ambulance currently exists.
STUDY OBJECTIVE


The objective of this study was to determine if various ambulance driving conditions (stationary, constant acceleration, serpentine, and start-stop) would impact paramedics' abilities to perform LUS on a standardized patient (SP) using breath-holding to simulate lung pathology, or to perform LUS using ultrasound (US) simulation software. Primary endpoints included the participating paramedics': (1) time to acquiring a satisfactory simulated LUS image; and (2) accuracy of image recognition and interpretation. Secondary endpoints for the breath-holding portion included: (1) the agreement between image interpretation by paramedic versus blinded expert reviewers; and (2) the quality of captured LUS image as determined by two blinded expert reviewers. Finally, a paramedic LUS training session was evaluated by comparing pre-test to post-test scores on a 25-item assessment requiring the recognition of a clinical interpretation of prerecorded LUS images.
METHODS


Seventeen paramedics received a 45-minute LUS lecture. They then performed 25 LUS exams on both SPs and using simulation software, in each case looking for lung sliding, A and B lines, and seashore or barcode signs. Pre- and post-training, they completed a 25-question test consisting of still images and videos requiring pathology recognition and formulation of a clinical diagnosis. Sixteen paramedics performed the same exams in an ambulance during different driving conditions (stationary, constant acceleration, serpentines, and abrupt start-stops). Lung pathology was block randomized based on driving condition.
RESULTS


Paramedics demonstrated improved post-test scores compared to pre-test scores (P <.001). No significant difference existed across driving conditions for: time needed to obtain a simulated image; clinical interpretation of simulated LUS images; quality of saved images; or agreement of image interpretation between paramedics and blinded emergency physicians (EPs). Image acquisition time while parked was significantly greater than while the ambulance was driving in serpentines (Z = -2.898; P = .008). Technical challenges for both simulation techniques were noted.
CONCLUSION


Paramedics can correctly acquire and interpret simulated LUS images during different ambulance driving conditions. However, simulation techniques better adapted to this unique work environment are needed.",2020,No significant difference existed across driving conditions for: time needed to obtain a simulated image; clinical interpretation of simulated LUS images; quality of saved images; or agreement of image interpretation between paramedics and blinded emergency physicians (EPs).,"['Seventeen paramedics received a', 'Paramedics during Varied Ambulance Driving Conditions']","['Pre- and post-training', '45-minute LUS lecture', 'lung ultrasound (LUS']","['breath-holding portion included: (1) the agreement between image interpretation by paramedic versus blinded expert reviewers; and (2) the quality of captured LUS image', 'Image acquisition time', ""participating paramedics': (1) time to acquiring a satisfactory simulated LUS image; and (2) accuracy of image recognition and interpretation"", 'post-test scores']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560179', 'cui_str': 'Imaging interpretation'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0374014,No significant difference existed across driving conditions for: time needed to obtain a simulated image; clinical interpretation of simulated LUS images; quality of saved images; or agreement of image interpretation between paramedics and blinded emergency physicians (EPs).,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Maloney', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Hospital, Stony Brook, New YorkUSA.'}, {'ForeName': 'Daryl W', 'Initials': 'DW', 'LastName': 'Williams', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Hospital, Stony Brook, New YorkUSA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Reardon', 'Affiliation': 'Since study initiation, Dr. Reardon has changed affiliations and is now at: University of Vermont Medical Center, Department of Emergency Medicine, Burlington, VermontUSA.'}, {'ForeName': 'R Trevor', 'Initials': 'RT', 'LastName': 'Marshall', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Hospital, Stony Brook, New YorkUSA.'}, {'ForeName': 'Andrus', 'Initials': 'A', 'LastName': 'Alian', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Hospital, Stony Brook, New YorkUSA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Boyle', 'Affiliation': 'Since study initiation, Mr. Boyle has changed affiliations and is now at: Stony Brook University, School of Health Technology and Management, Stony Brook, New YorkUSA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Secko', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Hospital, Stony Brook, New YorkUSA.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20001247']
1658,33109331,Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.,"BACKGROUND


Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased.
OBJECTIVE


To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite.
DESIGN


Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study.
SETTING


Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017.
PARTICIPANTS


Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs.
INTERVENTIONS


Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union.
MAIN OUTCOME MEASURES


The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work.
RESULTS


The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery,  n  = 203 of 219; cast,  n  = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6;  p  = 0.27). The non-union rate was low (surgery group,  n  = 1; cast group,  n  = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset.
LIMITATION


There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery.
CONCLUSIONS


Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN67901257.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.",2020,"There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6;  p  = 0.27).","['408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery,  n \u2009=\u2009203 of 219; cast,  n \u2009=\u2009205 of 220', 'The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61', 'adults with scaphoid waist fractures', 'Adults (aged ≥\u200916 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs', 'Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017', ""patients' desire to have a 'sense of recovering', which surgeons should address at the outset"", 'adults with a bicortical fracture of the scaphoid waist', '17 participants who had initial cast treatment and surgery for confirmed non-union', 'Adult patients with an undisplaced or minimally displaced scaphoid waist fracture', 'young men']","['Surgical fixation', 'surgical fixation with cast treatment and early fixation', 'Conformité Européenne-marked headless compression screws', 'cast immobilisation']","['clinical effectiveness and cost-effectiveness', 'total of 11 reoperations', 'reoperation for non-union', 'Patient-Rated Wrist Evaluation total score', 'non-union rate', 'Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work']","[{'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0585058', 'cui_str': 'Undisplaced fracture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0448063', 'cui_str': 'Entire waist of scaphoid bone'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}]",408.0,0.267233,"There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6;  p  = 0.27).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dias', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brealey', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leighton', 'Affiliation': ""School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hodgson', 'Affiliation': 'Department of Orthopaedic Surgery, Bolton NHS Foundation Trust, Royal Bolton Hospital, Bolton, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jefferson', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kanagaratnam', 'Initials': 'K', 'LastName': 'Jeyapalan', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Taub', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Tew', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Alcuin Research Resource Centre Building, Department of Health Sciences, University of York, York, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24520']
1659,33109378,"Re: Karim Fizazi, Charles G. Drake, Tomasz M. Beer, et al. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.032: Interpreting the Effect of Ipilimumab Following Radiotherapy for Patients with Postdocetaxel Metastatic Castration-resistant Prostate Cancer.",,2020,,['Patients with Postdocetaxel Metastatic Castration-resistant Prostate Cancer'],"['Ipilimumab Versus Placebo', 'Ipilimumab Following Radiotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0977285,,"[{'ForeName': 'Ethan B', 'Initials': 'EB', 'LastName': 'Ludmir', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ebludmir@mdanderson.org.'}, {'ForeName': 'Zachary R', 'Initials': 'ZR', 'LastName': 'McCaw', 'Affiliation': 'Google LLC, Mountain View, CA, USA.'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}]",European urology,['10.1016/j.eururo.2020.09.049']
1660,33109386,Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers.,"PURPOSE


Hetrombopag, a novel, oral small molecule thrombopoietin receptor agonist, exhibits an obvious thrombocytopoietic effect with good safety. Hetrombopag is currently under clinical development for the treatment of chronic idiopathic thrombocytopenic purpura (ITP). The objectives of this study were to assess the effect of high-fat and high-calorie food on the pharmacokinetic and pharmacodynamic (PK/PD) profiles of hetrombopag in healthy volunteers.
METHODS


An independent, single-dose, open-label, randomized-sequence, crossover trial was conducted. Healthy volunteers received hetrombopag 7.5-mg tablets in the fasted state or with a high-fat, high-calorie breakfast. The effects of the high-fat and high-calorie food on the PK/PD profiles of hetrombopag were evaluated by using a noncompartmental analysis and a semi-physiological model.
FINDINGS


Twelve Chinese healthy volunteers were enrolled. Mean plasma AUC 0-t  and C max  decreased by 98.7% and 95.0%, respectively, when hetrombopag was administered with high-fat and high-calorie food. The semi-physiological PK/PD model analysis showed that the absorption rate constant at the first absorption site was almost halved at the fed condition. The change in platelet counts in the fed condition was not sufficiently as sensitive as that in the fasted condition.
IMPLICATIONS


High-fat and high-calorie food were associated with significantly reduced systemic exposure and platelet count sensitivity. Thus, hetrombopag should be taken in a fasted state to avoid the impact of food on bioavailability and platelet counts. ClinicalTrials.gov identifier: NCT02409394.",2020,"Mean plasma AUC 0-t  and C max  decreased by 98.7% and 95.0%, respectively, when hetrombopag was administered with high-fat and high-calorie food.","['Twelve Chinese healthy volunteers were enrolled', 'healthy volunteers', 'Healthy Volunteers', 'chronic idiopathic thrombocytopenic purpura (ITP', 'Healthy volunteers']","['hetrombopag 7.5-mg tablets', 'high-fat and high-calorie food']","['Mean plasma AUC 0-t  and C max', 'pharmacokinetic and pharmacodynamic (PK/PD) profiles of hetrombopag', 'absorption rate constant', 'platelet counts']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0272293', 'cui_str': 'Chronic idiopathic thrombocytopenic purpura'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}]","[{'cui': 'C4505753', 'cui_str': 'hetrombopag'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0453831', 'cui_str': 'High energy food'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C4505753', 'cui_str': 'hetrombopag'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}]",12.0,0.030077,"Mean plasma AUC 0-t  and C max  decreased by 98.7% and 95.0%, respectively, when hetrombopag was administered with high-fat and high-calorie food.","[{'ForeName': 'Zhenlei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'GCP Center/Institute of Clinical Pharmacology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Aiwei', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Faculty of Pharmacy, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'GCP Center/Institute of Clinical Pharmacology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center/Institute of Clinical Pharmacology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'GCP Center/Institute of Clinical Pharmacology, West China Hospital of Sichuan University, Chengdu, China. Electronic address: lzheng2005618@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.10.002']
1661,33109390,Understanding the reactogenicity of 4CMenB vaccine: Comparison of a novel and conventional method of assessing post-immunisation fever and correlation with pre-release in vitro pyrogen testing.,"BACKGROUND


Better understanding of vaccine reactogenicity is crucial given its potential impact upon vaccine safety and acceptance. Here we report a comparison between conventional and novel (continuous) methods of monitoring temperature and evaluate any association between reactogenicity and the monocyte activation test (MAT) employed for testing four-component capsular group B meningococcal vaccine (4CMenB) batches prior to release for clinical use in Europe.
METHODS


Healthy 7-12-week-old infants were randomised in two groups: group PCV13 2 + 1 (received pneumococcal conjugate vaccine 13 valent (PCV13) at 2, 4 and 12 months) and group PCV13 1 + 1 (received reduced schedule at 3 and 12 months). In both, infants received the remaining immunisations as per UK national schedule (including 4CMenB at 2, 4 and 12 months of age). Fever was measured for the first 24 h after immunisations using an axillary thermometer and with a wireless continuous temperature monitoring device (iButton®). To measure the relative pyrogenicity of individual 4CMenB batches, MAT was performed according to Ph. Eu. chapter 2.6.30 method C using PBMCs with IL-6 readout.
RESULTS


Fever rates detected by the iButton® ranged from 28.7% to 76.5% and from 46.6% to 71.1% in group PCV13 2 + 1 and PCV13 1 + 1 respectively, across all study visits. The iButton® recorded a higher number of fever episodes when compared with axillary measurements in both groups (range of axillary temperature fevers; group PCV13 2 + 1: 6.7%-38%; group PCV13 1 + 1: 11.4%-37.1%). An agreement between the two methods was between 0.39 and 0.36 (p < 0.001) at 8 h' time-point post primary immunisations. No correlation was found between MAT scores and fever rates, or other reported adverse events.
CONCLUSIONS


It is likely that conventional, intermittent, fever measurements underestimates fever rates following immunisation. 4CMenB MAT scores didn't predict reactogenicity, providing reassurance that vaccine batches with the highest acceptable pyrogen level are not associated with an increase in adverse events. Clinicaltrials.gov identifier: NCT02482636.",2020,An agreement between the two methods was between 0.39 and 0.36 (p < 0.001) at 8 h' time-point post primary immunisations.,['Healthy 7-12-week-old infants'],"['PCV13 2\u202f+\u202f1 (received pneumococcal conjugate vaccine 13 valent (PCV13) at 2, 4 and 12\u202fmonths) and group PCV13 1\u202f+\u202f1', '4CMenB', '4CMenB vaccine']","['MAT scores and fever rates', 'Fever', 'Fever rates', 'MAT scores', 'adverse events', 'fever episodes']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3490189', 'cui_str': '4CMenB vaccine'}]","[{'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.073554,An agreement between the two methods was between 0.39 and 0.36 (p < 0.001) at 8 h' time-point post primary immunisations.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Valente Pinto', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, NIHR Oxford Biomedical Research Centre, United Kingdom. Electronic address: marta.valentepinto@paediatrics.ox.ac.uk.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Andrews', 'Affiliation': 'Statistics, Modelling and Economics Department, Public Health England, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Immunobiology Unit, UCL, Great Ormond Street Institute of Child Health, Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Southern', 'Affiliation': 'Immunisation, Hepatitis and Blood Safety Department, National Infection Service, Public Health England, London, United Kingdom.'}, {'ForeName': 'Ida Karin', 'Initials': 'IK', 'LastName': 'Nordgren', 'Affiliation': 'Division of Biotherapeutics, The National Institute for Biological Standards and Control, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Vipond', 'Affiliation': 'Division of Bacteriology, The National Institute for Biological Standards and Control, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Department of Infectious Disease Epidemiology, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, NIHR Oxford Biomedical Research Centre, United Kingdom.'}]",Vaccine,['10.1016/j.vaccine.2020.10.023']
1662,33109394,Cue-based treatment for light smokers: A proof of concept pilot.,"INTRODUCTION


Light smoking (smoking ≤ 10 cigarettes per day or on some days) has become increasingly prevalent in the US and increases morbidity and mortality. Many light smokers do not experience significant nicotine withdrawal but instead smoke in response to cues. Minimal evidence exists supporting interventions to help light smokers quit smoking.
METHODS


We present results from a proof-of-concept pilot study designed to evaluate the feasibility and acceptability of a cue-based smoking cessation intervention targeted to light daily and intermittent smokers. Participants were randomized to one of two arms: Arm 1) standard smoking cessation treatment or Arm 2) standard smoking cessation treatment + enhanced cue-based treatment that included interactive texting to extend cue exposure treatment to real-world settings and cue management counseling.Outcomes included feasibility (number of participants who were recruited and who completed the intervention), acceptability (intervention ratings), and preliminary efficacy (7-day point prevalence abstinence).
RESULTS


We randomized 24 English and Spanish-speaking light smokers, 13 to the treatment arm and 11 to the control arm. Across both arms, 77% attended all counseling sessions, 90% rated these sessions as very useful and 100% said that they would recommend the intervention to a friend. 15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
CONCLUSIONS


Results from this proof-of-concept study demonstrated that a cue-based intervention is feasible and acceptable among light smokers and suggests the need for a fully powered study to assess this approach.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03416621.",2020,"15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
",['light smokers'],"['Cue-based treatment', 'cue-based smoking cessation intervention', 'standard smoking cessation treatment or Arm 2) standard smoking cessation treatment\xa0+\xa0enhanced cue-based treatment that included interactive texting to extend cue exposure treatment to real-world settings and cue management counseling']","['morbidity and mortality', 'biochemically-validated smoking abstinence']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",24.0,0.0327941,"15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
","[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States. Electronic address: kathryn.pollak@duke.edu.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Oliver', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, United States.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; School of Nursing, Duke University, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Granados', 'Affiliation': 'Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Family Medicine and Community Health, Duke University School of Medicine, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106717']
1663,33097016,Spillover HIV prevention effects of a cash transfer trial in East Zimbabwe: evidence from a cluster-randomised trial and general-population survey.,"BACKGROUND


Benefits of cash transfers (CTs) for HIV prevention have been demonstrated largely in purposively designed trials, commonly focusing on young women. It is less clear if CT interventions not designed for HIV prevention can have HIV-specific effects, including adverse effects. The cluster-randomised Manicaland Cash Transfer Trial (2010-11) evaluated effects of CTs on children's (2-17 years) development in eastern Zimbabwe. We evaluated whether this CT intervention with no HIV-specific objectives had unintended HIV prevention spillover effects (externalities).
METHODS


Data on 2909 individuals (15-54 years) living in trial households were taken from a general-population survey, conducted simultaneously in the same communities as the Manicaland Trial. Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years). Outcomes were also evaluated with a larger synthetic comparison group created through propensity score matching.
RESULTS


CTs did not affect sexual debut but reduced having any recent sex (past 30 days) among young males (ATE: - 11.7 percentage points [PP] [95% confidence interval: -26.0PP, 2.61PP]) and females (- 5.68PP [- 15.7PP, 4.34PP]), with similar but less uncertain estimates when compared against the synthetic comparison group (males: -9.68PP [- 13.1PP, - 6.30PP]; females: -8.77PP [- 16.3PP, - 1.23PP]). There were no effects among older individuals. Young (but not older) males receiving CTs reported increased multiple partnerships (8.49PP [- 5.40PP, 22.4PP]; synthetic comparison: 10.3PP (1.27PP, 19.2PP). No impact on alcohol, cigarette, or drug consumption was found. There are indications that CTs reduced psychological distress among young people, although impacts were small. CTs increased school enrolment in males (11.5PP [3.05PP, 19.9PP]). Analyses with the synthetic comparison group (but not the original control group) further indicated increased school enrolment among females (5.50PP [1.62PP, 9.37PP]) and condom use among younger and older women receiving CTs (9.38PP [5.90PP, 12.9PP]; 5.95PP [1.46PP, 10.4PP]).
CONCLUSIONS


Non-HIV-prevention CT interventions can have HIV prevention outcomes, including reduced sexual activity among young people and increased multiple partnerships among young men. No effects on sexual debut or alcohol, cigarette, or drug consumption were observed. A broad approach is necessary to evaluate CT interventions to capture unintended outcomes, particularly in economic evaluations.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT00966849 . Registered August 27, 2009.",2020,"Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years).","[""children's (2-17\u2009years) development in eastern Zimbabwe"", 'young women', 'group (males: -9.68PP [-\u200913.1PP, -\u20096.30PP]; females: -8.77PP [-\u200916.3PP, -\u20091.23PP', 'East Zimbabwe', 'Young (but not older) males receiving', 'Data on 2909 individuals (15-54\u2009years) living in trial households were taken from a general-population survey, conducted simultaneously in the same communities as the Manicaland Trial']","['cash transfers (CTs', 'CT intervention', 'synthetic comparison', 'CTs']","['alcohol, cigarette, or drug consumption', 'psychological distress', 'sexual debut or alcohol, cigarette, or drug consumption', 'CTs increased school enrolment', 'sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption', 'school enrolment', 'sexual activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}]",2909.0,0.0379822,"Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years).","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK. r.schaefer@imperial.ac.uk.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robertson', 'Affiliation': 'Independent, London, UK.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Eaton', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mushati', 'Affiliation': 'Independent, Harare, Zimbabwe.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}]",BMC public health,['10.1186/s12889-020-09667-5']
1664,33097017,Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial.,"BACKGROUND


Urinary tract infections (UTIs) are one of the most common bacterial infections in children. In children < 7 years of age, the prevalence of one episode of symptomatic UTI has been estimated at 3-7% in girls and 1-2% in boys, whereas 8-30% of them will have one or more episodes of UTI. The use of some probiotics appears to reduce the risk of recurrence of UTIs. Since the effects of probiotics are strain-specific, the efficacy and safety of each strain has to be assessed. The main aim of this study is to determine whether probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy are effective in preventing UTI in children compared to placebo.
METHOD


A superiority, double-blind, randomised, controlled trial is being conducted. One hundred and six patients aged 3 to 18 years with recurrent UTIs in last year (defined as: ≥ 2 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and ≥ 1 episodes of UTI with cystitis/lower UTI; or ≥ 3 episodes of UTI with cystitis/lower UTI) or children with ≥ 1 infection in the upper urinary tract and ≥ 1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1) or a 90-day placebo arm. The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
DISCUSSION


The findings of this randomised controlled trial (RCT), whether positive or negative, will contribute to the formulation of further recommendations on prevention of recurrent UTIs in children.
TRIAL REGISTRATION NUMBER


NCT03462160, date of trial registration 12th March 2018.",2020,"The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
","['children', 'One hundred and six patients aged 3 to 18\xa0years with recurrent UTIs in last year (defined as:\u2009≥\u20092 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and\u2009≥\u20091 episodes of UTI with cystitis/lower UTI; or\u2009≥\u20093 episodes of UTI with cystitis/lower UTI) or children with\u2009≥\u20091 infection in the upper urinary tract and\u2009≥\u20091 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls']","['Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo', 'probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy', '90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1']","['recurrence urinary tract infections', 'frequency of recurrence of UTI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1968949', 'cui_str': 'Cakut'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0456957', 'cui_str': 'Metastasis stage pM1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",106.0,0.221633,"The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szymanik-Grzelak', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland. h.szymanik@interia.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Turczyn', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Pańczyk-Tomaszewska', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}]",BMC urology,['10.1186/s12894-020-00723-1']
1665,33097026,Cost-utility and cost-benefit analyses of school-based obesity prevention program.,"BACKGROUND


Economic evaluation of school-based obesity interventions could provide support for public health decision of obesity prevention. This study is to perform cost-utility and cost-benefit assessment of three school-based childhood obesity interventions including nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP) with secondary data analysis of one randomized controlled trial.
METHODS


The standard cost-effectiveness analysis methods were employed from a societal perspective to the health outcome and costs that are attributable to the intervention. NE, PA and CNP were carried out separately for 2 semesters for childhood obesity interventions in primary schools. The additional quality-adjusted life years (QALYs) resulting from the interventions were measured as the health outcome. A cost-utility ratio (CUR) and A cost-benefit ratio (CBR) was calculated as the ratio of implementation costs to the total medical and productivity loss costs averted by the interventions.
RESULTS


The CUR and CBR were ¥11,505.9 ($1646.0) per QALY and ¥1.2 benefit per ¥1 cost respectively, and the net saving was ¥73,659.6 ($10,537.9). The CUR and CBR for nutrition education and physical activity interventions were ¥21,316.4 ($3049.6) per QALY and ¥0.7 benefit per ¥1 cost, ¥28,417.1 ($4065.4) per QALY and ¥0.4 benefit per ¥1 cost, respectively (in 2019 RMB). Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively. The CBR was ¥1.2, 0.7, and 0.4 benefits per ¥1 cost for CNP, NE, and PA interventions, respectively. Net estimated savings were achieved only through CNP intervention, amounting to ¥73,659.6 ($10,537.9).
CONCLUSIONS


Comprehensive school-based obesity intervention is a beneficial investment that is both cost-effective and cost saving. Compared with PA intervention, both CNP and NE intervention were more cost-effective.",2020,"Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively.",[],"['school-based obesity prevention program', 'nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP', 'CNP and NE intervention', 'Comprehensive school-based obesity intervention', 'NE, PA and CNP']","['cost-utility ratio (CUR) and A cost-benefit ratio (CBR', 'cost-effective', 'ICERs', 'CUR and CBR', 'Net estimated savings']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}, {'cui': 'C0557796', 'cui_str': 'Comprehensive school'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",,0.0269197,"Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively.","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, 38 Xue Yuan Road, Beijing, 100191, China. mags@bjmu.edu.cn.'}]",BMC public health,['10.1186/s12889-020-09718-x']
1666,33097954,"An Expression of Concern from The Journal of Nutrition's Editorial Office about: Vitamin D Supplementation Affects the Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress in Patients with Major Depressive Disorder: A Randomized, Controlled Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Vitamin D Supplementation'],"['Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.232398,,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sepehrmanesh', 'Affiliation': ''}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Kolahdooz', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abedi', 'Affiliation': ''}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazroii', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Assarian', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa341']
1667,33098159,Preventing depression among older people living in rural areas: A randomised controlled trial of behavioural activation in collaborative care.,"OBJECTIVES


This study aimed to test if a behavioural activation (BA) programme was more effective than usual care at reducing the risk of conversion to major depression over 52 weeks among adults aged 65 years or older living in rural Western Australia. Secondary aims were to test if participants assigned to the BA intervention experienced greater decline in the severity of depressive and anxiety symptoms than older adults treated with usual care over 26 and 52 weeks, as well as greater improvement in physical and mental health-related quality of life.
METHODS


Randomised controlled clinical trial that started recruitment in February 2016 in rural Western Australia. We used the electoral roll to invite adults aged 65 years or over living in suitable regions of Western Australia to take part in the study. We recruited those who consented and screened positive to at least one of the two Whooley questions: feeling down/depressed/hopeless or little interest or pleasure over the past month. Participants were randomly assigned to usual care or usual care plus a phone-delivered BA program (1:1). The intervention consisted of a self-managed BA program supported by three 45-min phone sessions delivered by a BA therapist over a period of 8 weeks. We used the DSM-5 criteria to establish the presence of a major depressive episode, and Patient Health Questionnaire, Generalised Anxiety Disorder Scale and SF-36 to assess symptoms of depression, anxiety and quality of life.
RESULTS


Of the 309 older adults randomised, 307 started the trial: 153 usual care and 154 BA (computer-generated random permuted even blocks ranging in size from 8 to 20). Six participants developed a major depressive episode during follow-up, four of them in the usual care group (odds ratio of depression associated with the intervention = 0.49, 95% CI = 0.04, 3.49-blind assessment). Seventy-three (23.8%) participants were lost over 52 weeks-there were no differences between usual care and intervention group. Intention-to-treat analyses using mixed regression models found modest non-significant effects of the BA intervention, while complete-case analyses showed that participants treated with BA compared with usual care experienced significant improvements in depression and anxiety symptoms over 52 weeks, as well as improved mental health quality of life.
CONCLUSIONS


Few participants developed a major depressive episode during follow-up. The BA intervention was associated with improved symptoms of depression and anxiety, although the clinical significance of these benefits remains unclear.",2020,Seventy-three (23.8%) participants were lost over 52 weeks - there were no differences between usual care and intervention group.,"['February 2016 in rural Western Australia', 'invite adults aged 65 years or over living in suitable regions of Western Australia to take part in the study', 'We recruited those who consented and screened positive to at least one of the two Whooley questions: feeling down/depressed/hopeless or little interest or pleasure over the past month', ' 307 started the trial: 153 usual care and 154 BA', '309 older adults randomised', 'adults aged 65 years or older living in rural Western Australia', 'Older People Living in Rural Areas']","['behavioural activation (BA) program', 'usual care or usual care plus a phone-delivered BA program', 'BA intervention', 'self-managed BA program supported by three 45-minute phone sessions delivered by a BA therapist']","['physical and mental health-related quality of life', 'mental health quality of life', 'major depressive episode', 'depression, anxiety and quality of life', 'severity of depressive and anxiety symptoms', 'symptoms of depression and anxiety', 'depression and anxiety symptoms']","[{'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.114435,Seventy-three (23.8%) participants were lost over 52 weeks - there were no differences between usual care and intervention group.,"[{'ForeName': 'Osvaldo P', 'Initials': 'OP', 'LastName': 'Almeida', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelly', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'WA Centre for Rural Health, School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",International journal of geriatric psychiatry,['10.1002/gps.5449']
1668,31043691,Systemic inflammation is associated with malaria and preterm birth in women living with HIV on antiretrovirals and co-trimoxazole.,"Women living with HIV (WLHIV) have an increased risk of malaria in pregnancy (MiP). It is unclear if MiP in WLHIV causes a systemic inflammatory response and increases the risk of adverse birth outcomes, especially for women receiving antiretroviral therapy (ART) and daily trimethoprim-sulfamethoxazole (TMP/SXT). We analyzed repeated plasma samples in a cohort of malaria-exposed Ugandan WLHIV receiving ART and daily TMP/SXT to examine changes in inflammatory markers across pregnancy and their association with birth outcomes. Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women. MiP was associated with increased sTNFR2, sICAM-1 and IL-18BP concentrations across pregnancy. Women who delivered preterm had elevated concentrations of sTNFR2 and altered levels of IL-6 during pregnancy. Women with sTNFR2 concentrations in the highest quartile within 6 weeks of delivery had an increased relative risk of preterm birth. Our results indicate that despite daily TMP/SXT, MiP in WLHIV induced a systemic inflammatory response that was associated with an increased risk of preterm birth. These findings highlight the need for additional strategies to protect WLHIV from malaria infection in pregnancy to promote healthy outcomes for mother and child.",2019,"Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women.","['women receiving antiretroviral therapy (ART) and daily', 'Women living with HIV (WLHIV', 'women living with HIV on antiretrovirals and co-trimoxazole']","['trimethoprim-sulfamethoxazole (TMP/SXT', 'TMP/SXT']","['Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2', 'relative risk of preterm birth', 'elevated concentrations of sTNFR2 and altered levels of IL-6', 'risk of malaria in pregnancy (MiP', 'sTNFR2, sICAM-1 and IL-18BP concentrations', 'risk of preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0040079', 'cui_str': 'Deoxythymidylic acid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1743775', 'cui_str': 'IL18BP protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}]",,0.365901,"Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women.","[{'ForeName': 'Chloe R', 'Initials': 'CR', 'LastName': 'McDonald', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Weckman', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Conroy', 'Affiliation': 'Department of Pediatrics, Indiana University, School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Kain', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Toronto, Ontario, Canada. kevin.kain@uhn.ca.'}]",Scientific reports,['10.1038/s41598-019-43191-w']
1669,33099015,"Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.","Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs.
OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
METHODS


The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination.
CONCLUSIONS


If successful, the intervention could be incorporated as a 'best practice' through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.",2020,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
",['caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12\u202fmonths of age'],"['healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling']","['infant rate of weight gain at 12\u202fmonths; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors', 'Rapid weight gain', 'healthy weight gain and specific behaviors (physical activity, sleep, diet']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4277516', 'cui_str': 'Special Supplemental Nutrition Program for Women, Infants, and Children (U.S.)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",14.0,0.0627379,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Dental and Craniofacial Genomics Core, Endocrinology Section School of Medicine, University of Puerto Rico, San Juan 00936-5067, Puerto Rico. Electronic address: maribel.campos@upr.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pomeroy', 'Affiliation': 'Clinical Research Center, Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA. Electronic address: pomeroyj@marshfieldclinic.org.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mays', 'Affiliation': 'Biomedical Informatics Core, Puerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico. Electronic address: mary.mays@upr.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Sports and Leisure Management program and Adapted Physical Education program, School of Education, Metropolitan University, San Juan Puerto Rico. Electronic address: lopeza1@suagm.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, Miami USA. Electronic address: cristina.palacios@fiu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106185']
1670,33099054,"A randomised controlled trial of metacognitive training for psychosis, depression, and belief flexibility.","BACKGROUND


Metacognitive training (MCT) has been shown to be effective in reducing psychotic symptoms, including delusions. However, less is known on whether MCT, or its specific modules, are effective in ameliorating reasoning biases e.g. belief flexibility. As inflexibility in appraisal has been associated with psychosis and major depressive disorder (MDD), this study examined the efficacy of a 4-session MCT on delusions, depression, and belief flexibility, in two clinical groups (Psychosis and Depression).
METHODS


This study adopted a single-blind randomised controlled design, with patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition. The MCT intervention consisted of specific modules targeting belief flexibility. Participants were assessed before and after treatment, and at 1- and 6-month follow-ups.
RESULTS


Among the 113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT. There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group. Symptom improvements following MCT were of large effect sizes, were significantly greater than TAU, and persisted at 6-month. Belief flexibility also improved in both groups, although changes were smaller in size and were not significantly greater than TAU.
LIMITATIONS


An active control condition was not included.
CONCLUSIONS


This study demonstrated large and stable symptom reductions in delusions and depression, and smaller (yet stable) improvement in belief flexibility across groups, following a 4-session MCT, carrying implications for transdiagnostic process-based interventions and their mechanisms of change.",2020,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","['patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition', '113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT']","['MCT', 'Metacognitive training (MCT', 'metacognitive training']","['Belief flexibility', 'depressive symptoms', 'psychotic symptoms, especially delusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]",27.0,0.0534335,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ho-Wai So', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR. Electronic address: shwso@psy.cuhk.edu.hk.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hoi-Kei Chan', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Cheris', 'Initials': 'C', 'LastName': 'Kit-Wa Wong', 'Affiliation': 'Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Wing-Ka Ching', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sze-Wai Lee', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chi-Wing Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kin-Hei Chung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Alyse Yu', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Oi-Yin Wong', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sau-Man Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.126']
1671,33099083,Selfhood triumvirate: From phenomenology to brain activity and back again.,"Recently, a three-dimensional construct model for complex experiential Selfhood has been proposed (Fingelkurts, Fingelkurts, & Kallio-Tamminen, 2016b,c). According to this model, three specific subnets (or modules) of the brain self-referential network (SRN) are responsible for the manifestation of three aspects/features of the subjective sense of Selfhood. Follow up multiple studies established a tight relation between alterations in the functional integrity of the triad of SRN modules and related to them three aspects/features of the sense of self; however, the causality of this relation is yet to be shown. In this article we approached the question of causality by exploring functional integrity within the three SRN modules that are thought to underlie the three phenomenal components of Selfhood while these components were manipulated mentally by experienced meditators in a controlled and independent manner. Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG). This EEG-data was complemented by first-person phenomenological reports and standardised questionnaires which focused on subjective contents of three aspects of Selfhood. The results of the study strengthen the case for a direct causative relationship between three phenomenological aspects of Selfhood and related to them three modules of the brain SRN. Furthermore, the putative integrative model of the dynamic interrelations among three modules of the SRN has been proposed.",2020,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).",[],"['mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG']",[],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],,0.0183146,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland. Electronic address: andrew.fingelkurts@bm-science.com.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kallio-Tamminen', 'Affiliation': 'Physics Foundations Society and Society for Natural Philosophy, Helsinki, Finland.'}]",Consciousness and cognition,['10.1016/j.concog.2020.103031']
1672,33099227,Effect of growth hormone treatment on circulating levels of NT-proBNP in patients with ischemic heart failure.,"AIMS


Growth hormone (GH) therapy in heart failure (HF) is controversial. We investigated the cardiovascular effects of GH in patients with chronic HF due to ischemic heart disease.
METHODS


In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic HF (ejection fraction [EF] < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).
RESULTS


No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class. In the GH group, circulating levels of IGF-1 doubled from baseline (+105%; p < 0.001) and NT-proBNP levels halved (-48%; p < 0.001) during the treatment period, with subsequently a partial return of both towards baseline levels. No changes in IGF-1 or NT-proBNP were observed in the placebo group at any time during the study.
CONCLUSION


In patients with chronic ischemic HF, nine months of GH treatment was associated with significant increases in levels of IGF-1 and reductions in levels of NT-proBNP, but did not affect cardiac structure, systolic function or functional capacity.",2020,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"['patients with chronic HF due to ischemic heart disease', 'heart failure (HF', 'patients with ischemic heart failure', '37 patients (mean age 66\xa0years; 95% male) with ischemic HF']","['growth hormone treatment', 'GH', 'recombinant human GH', 'placebo', 'Growth hormone (GH) therapy']","['circulating levels of IGF-1', 'circulating levels of NT-proBNP', 'changes in cardiac structure and EF', 'changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP', 'IGF-1 or NT-proBNP', 'NT-proBNP levels', 'change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR', 'cardiac structure or systolic function', 'cardiac structure, systolic function or functional capacity', 'levels of IGF-1 and reductions in levels of NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",37.0,0.265861,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: kristjan.karason@gu.se.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bobbio', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Polte', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Departments of Clinical Physiology and Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Entela', 'Initials': 'E', 'LastName': 'Bollano', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Caidahl', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute (KI), Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Hjalmarson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt-Åke', 'Initials': 'BÅ', 'LastName': 'Bengtsson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ekelund', 'Affiliation': 'Centre of Registers Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Isgaard', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101359']
1673,33099944,Efficacy of different regimens in nasal NK/T-cell lymphoma and analysis of serum inflammation and prognosis of patients.,"PURPOSE


To explore the efficacy of different regimens in nasal natural killer (NK)/T-cell lymphoma (NNKTL) and their effects on the serum inflammation and prognosis of patients.
METHODS


146 NNKTL patients admitted to and treated in the Oncology Department of our hospital from January 2010 to December 2014 were randomly enrolled and divided into chemotherapy group (group A) and concurrent chemoradiotherapy group (group B). The expression levels of interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) before and after treatment were detected, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed.
RESULTS


In group A and group B, the total short-term effective rate was 71.87% and 84.97%, the 5-year overall survival (OS) rate was 39.9% and 66.2%, and the progression-free survival (PFS) rate was 18.1% and 46.9%, respectively. Treatment regimens, clinical stage, the presence of B symptoms and lactate dehydrogenase (LDH) level were independent factors related to prognosis, and the remission rate after the first-course chemotherapy was an independent factor unrelated to prognosis. After treatment, there was no significant difference in the IL-2 level between the two groups of patients before and after treatment. The expression level of TNF-α after treatment was reduced compared with that before treatment, and the reduction was more obvious in group B.
CONCLUSIONS


The short-term efficacy of concurrent chemoradiotherapy favors NNKTL, and the therapy can reduce the expression level of TNF-α.",2020,"The expression levels of interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) before and after treatment were detected, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed.
","['146 NNKTL patients admitted to and treated in the Oncology Department of our hospital from January 2010 to December 2014', 'patients']","['concurrent chemoradiotherapy', 'chemotherapy']","['total short-term effective rate', 'presence of B symptoms and lactate dehydrogenase (LDH) level', 'IL-2 level', '5-year overall survival (OS) rate', 'progression-free survival (PFS) rate', 'remission rate', 'expression levels of interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α', 'expression level of TNF-α']","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",146.0,0.0244839,"The expression levels of interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) before and after treatment were detected, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed.
","[{'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology, Hongqi Hospital Affiliated to Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1674,33099947,The effect of neo-adjuvant chemotherapy on the improvement of oral cancer patients and the predictive value of miR-182 on its efficacy.,"PURPOSE


This study aimed to observe the effect of neo-adjuvant chemotherapy on the improvement of oral cancer patients and investigate the predictive value of miR-182 on its efficacy.
METHODS


A total of 143 patients with advanced oral cancer admitted to Yidu Central Hospital of Weifang from September 2015 to July 2017 formed the study group. Among them, there were 62 cases in the control group (surgery+postoperative radiotherapy) and 81 cases in the study group (preoperative neo-adjuvant chemotherapy+surgery+postoperative radiotherapy). The treatment effect and adverse reactions of patients were compared between the two groups. RT-PCR was used to detect the expression levels of serum miR-182 of patients before and after treatment. The 1-year survival of patients in the two groups was recorded and compared by follow-up.
RESULTS


The total effective rate of patients in the study group was significantly higher than that of patients in the control group (p<0.05). The incidence of adverse reactions of patients in the study group was significantly higher than in the control group (p<0.05). There was no significant difference in the prognostic 1-year survival rate between the two groups. After treatment, the expression of miR-182 was lower than before treatment and in the study group it was significantly lower than the control group (p<0.05). ROC curve analysis showed that the area under the curve of miR-182 in the predictive value of oral cancer was 0.756. When the cut-off value was less than 1.823, the optimal specificity was 70.18% and the sensitivity was 75.86%.
CONCLUSION


Neo-adjuvant chemotherapy can significantly improve the therapeutic effect, but the incidence of adverse reactions increases. miR-182 may be involved in the occurrence and deterioration of oral cancer and is a good indicator for predicting the treatment efficacy of patients with oral cancer.",2020,"After treatment, the expression of miR-182 was lower than before treatment and in the study group it was significantly lower than the control group (p<0.05).","['oral cancer patients', 'patients with oral cancer', '143 patients with advanced oral cancer admitted to Yidu Central Hospital of Weifang from September 2015 to July 2017 formed the study group']","['neo-adjuvant chemotherapy', 'control group (surgery+postoperative radiotherapy']","['1-year survival', 'sensitivity', 'therapeutic effect', 'expression of miR-182', 'total effective rate', 'incidence of adverse reactions', 'prognostic 1-year survival rate']","[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",143.0,0.0196757,"After treatment, the expression of miR-182 was lower than before treatment and in the study group it was significantly lower than the control group (p<0.05).","[{'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Stomatology, Yidu Central Hospital of Weifang, Weifang 262500, P.R. China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': ''}, {'ForeName': 'Huiqiang', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1675,33099954,Metformin induces apoptosis of melanoma B16 cells via PI3K/Akt/mTOR signaling pathways.,"PURPOSE


To investigate the influences of metformin on the proliferation and apoptosis of mouse melanoma B16 cells through regulating the phosphatidylinositol 3-hydroxy kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway.
METHODS


The mouse melanoma B16 cell strains were taken as the subjects of the study, and were randomly divided into the control group with RPMI-640 medium with the volume same with that in the metformin group (C group, n=6) and Q group [metformin:10 mmol/L (Q1 group, n=6), metformin:20 mmol/L (Q2 group, n=6), and metformin:40 mmol/L (Q3 group, n=6)]. The cell counting kit-8 (CCK-8) method was employed to detect the proliferation of cells in each group at different culture times. The apoptosis of cells in each group was detected via flow cytometry and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL).
RESULTS


The proliferation rate in Q group was lower than in C group, and the difference was statistically significant (p<0.05 or p<0.01). According to the results of flow cytometry, it was concluded that the number of apoptotic cells in Q group was higher than in C group (p<0.05 or p<0.01). TUNEL results revealed that compared with that in C group, the apoptosis rate in Q group was increased (p<0.05 or p<0.01). Moreover, western blotting results showed that the protein expression levels of PI3K, Akt and mTOR in Q group were higher than in C group.
CONCLUSIONS


Metformin can inhibit the proliferation of mouse melanoma B16 cells and induce their apoptosis probably through its regulation on the PI3K/AKT/mTOR signaling pathway in cells.",2020,"The proliferation rate in Q group was lower than in C group, and the difference was statistically significant (p<0.05 or p<0.01).",[],"['Q group [metformin:10 mmol/L (Q1 group, n=6), metformin:20 mmol/L (Q2 group, n=6), and metformin:40 mmol/L', 'RPMI-640 medium with the volume same with that in the metformin', 'metformin', 'Metformin']","['number of apoptotic cells', 'protein expression levels of PI3K, Akt and mTOR', 'flow cytometry and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL', 'apoptosis of cells', 'apoptosis rate', 'proliferation rate']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031621', 'cui_str': 'Phosphatidylinositols'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0012881', 'cui_str': 'DNA nucleotidylexotransferase'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0057470', 'cui_str': 'deoxyuridine triphosphate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}]",,0.0165865,"The proliferation rate in Q group was lower than in C group, and the difference was statistically significant (p<0.05 or p<0.01).","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Dermatology, Dongzhimen Hospital Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1676,33099976,Comparison of the Anesthetic Effects of Isoflurane and Sevoflurane Inhalation on the Cardiovascular System of the Common Buzzard ( Buteo buteo ).,"The aim of this study was to compare the effects of isoflurane (ISO) and sevoflurane (SEVO) inhalation anesthesia on the cardiovascular system of the common buzzard ( Buteo buteo ). Fourteen common buzzards of unknown sex and age, weighing 700-900 g each, were used for the study. The buzzards were randomly divided into an ISO group and a SEVO group, each comprising 7 buzzards. The buzzards were then anesthetized by masked induction with either ISO or SEVO. After induction, all buzzards were intubated with a 2.5-mm-diameter uncuffed endotracheal tube. Anesthesia was maintained with 3% ISO or 4% SEVO in a 3 L/min flow of 100% oxygen. Before induction, immediately after induction, and at intervals of 5, 10, 15, 20, 25, and 30 min after the patients were induced, the heart rate, respiratory rate, and body temperature of the buzzards were recorded. In addition, before and during anesthesia, serum electrolytes (sodium, ionized calcium, and potassium), blood gas measurements (arterial pH, arterial partial pressure of carbon dioxide, arterial partial pressure of oxygen, bicarbonate concentration, and oxyhemoglobin saturation), and hematocrit values were evaluated in the blood samples taken from both the ISO and SEVO groups. A statistically significant decrease in body temperature was observed in both groups. A significant decrease in heart rate was observed in the ISO group. The increases in partial pressure of carbon dioxide and bicarbonate concentration were statistically significant in both groups. The effects of ISO and SEVO anesthesia on the cardiovascular and respiratory system in the buzzards were similar based on the results of this study.",2020,The increases in partial pressure of carbon dioxide and bicarbonate concentration were statistically significant in both groups.,"['Fourteen common buzzards of unknown sex and age, weighing 700-900 g each, were used for the study']","['isoflurane (ISO) and sevoflurane (SEVO) inhalation anesthesia', 'Isoflurane and Sevoflurane Inhalation', 'ISO or SEVO', 'ISO and SEVO anesthesia', 'SEVO']","['partial pressure of carbon dioxide and bicarbonate concentration', 'body temperature', 'heart rate, respiratory rate, and body temperature of the buzzards', 'heart rate', 'cardiovascular and respiratory system', 'serum electrolytes (sodium, ionized calcium, and potassium), blood gas measurements (arterial pH, arterial partial pressure of carbon dioxide, arterial partial pressure of oxygen, bicarbonate concentration, and oxyhemoglobin saturation), and hematocrit values']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0325562', 'cui_str': 'Common buzzard'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0261628,The increases in partial pressure of carbon dioxide and bicarbonate concentration were statistically significant in both groups.,"[{'ForeName': 'Rahime', 'Initials': 'R', 'LastName': 'Yaygingul', 'Affiliation': 'Aydin Adnan Menderes University, Veterinary Faculty, Department of Surgery, 09016 Isikli, Aydin, Turkey, ryaygingul@adu.edu.tr.'}]",Journal of avian medicine and surgery,['10.1647/1082-6742-34.3.237']
1677,33100020,Factors associated with non-adherence to insulin and non-insulin medications in patients with poorly controlled diabetes.,"OBJECTIVES


To evaluate differences in factors associated with self-reported medication non-adherence to insulin and non-insulin medications in patients with uncontrolled type 2 diabetes.
METHODS


In this secondary analysis of a randomized trial in patients with obesity and uncontrolled type 2 diabetes, multivariable logistic regression was used to evaluate associations between several clinical factors (measured with survey questionnaires at study baseline) and self-reported non-adherence to insulin and non-insulin medications.
RESULTS


Among 263 patients, reported non-adherence was 62% (52% for insulin, 55% for non-insulin medications). Reported non-adherence to non-insulin medications was less likely in white versus non-white patients (odds ratio (OR) = 0.42; 95%CI: 0.22,0.80) and with each additional medication taken (OR = 0.75; 95%CI: 0.61,0.93). Non-adherence to non-insulin medications was more likely with each point increase in a measure of diabetes medication intensity (OR = 1.43; 95%CI: 1.01,2.03), the Problem Areas in Diabetes (PAID) score (OR = 1.06; 95%CI: 1.02,1.12), and in men versus women (OR = 3.03; 95%CI: 1.06,8.65). For insulin, reporting non-adherence was more likely (OR = 1.02; 95%CI: 1.00,1.04) with each point increase in the PAID.
DISCUSSION


Despite similar overall rates of reported non-adherence to insulin and non-insulin medications, factors associated with reported non-adherence to each medication type differed. These findings may help tailor approaches to supporting adherence in patients using different types of diabetes medications.",2020,"Among 263 patients, reported non-adherence was 62% (52% for insulin, 55% for non-insulin medications).","['patients with poorly controlled diabetes', 'patients with uncontrolled type 2 diabetes', 'patients with obesity and uncontrolled type 2 diabetes', '263 patients']",['insulin and non-insulin medications'],"['Problem Areas in Diabetes (PAID) score', 'non-adherence', 'diabetes medication intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",263.0,0.0551374,"Among 263 patients, reported non-adherence was 62% (52% for insulin, 55% for non-insulin medications).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sagalla', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, USA.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}, {'ForeName': 'Moahad', 'Initials': 'M', 'LastName': 'Dar', 'Affiliation': 'Division of Endocrinology and Metabolism, East Carolina University, Greenville, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, USA.'}]",Chronic illness,['10.1177/1742395320968627']
1678,33100044,Vascular Effects of ACE (Angiotensin-Converting Enzyme) Inhibitors and Statins in Adolescents With Type 1 Diabetes.,"An increased albumin-creatinine ratio within the normal range can identify adolescents at higher risk of developing adverse cardio-renal outcomes as they progress into adulthood. Utilizing a parallel randomized controlled trial and observational cohort study, we characterized the progression of vascular phenotypes throughout this important period and investigated the effect of ACE (angiotensin-converting enzyme) inhibitors and statins in high-risk adolescents. Endothelial function (flow-mediated dilation and reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity) were assessed in 158 high-risk participants recruited to a randomized, double-blind placebo-controlled 2×2 factorial trial (randomized, placebo-controlled trial) of ACE inhibitors and/or statins in adolescents with type 1 diabetes (AdDIT [Adolescent Type 1 Diabetes cardio-renal Intervention Trial]). Identical measures were also assessed in 215 lower-risk individuals recruited to a parallel observational study. In the randomized, placebo-controlled trial, high-risk patients randomized to ACE inhibitors had improved flow-mediated dilation after 2 to 4 years of follow-up (mean [95% CI]: 6.6% [6.0-7.2] versus 5.3% [4.7-5.9];  P =0.005), whereas no effect was observed following statin use (6.2% [5.5-6.8] versus 5.8% [5.1-6.4];  P =0.358). In the observational study, patients classed as high-risk based on albumin-creatinine ratio showed evidence of endothelial dysfunction at the end of follow-up (flow-mediated dilation=4.8% [3.8-5.9] versus 6.3% [5.8-6.7] for high-risk versus low-risk groups;  P =0.015). Neither reactive hyperemia index nor pulse wave velocity were affected by either treatment ( P >0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12];  P =0.001 and 0.5 m/s [0.4-0.6];  P <0.001 for reactive hyperemia index and pulse wave velocity, respectively). ACE inhibitors improve endothelial function in high-risk adolescents as they transition through puberty. The longer-term protective effects of this intervention at this early age remain to be determined. Registration- URL: https://www.clinicaltrials.gov; Unique identifier NCT01581476.",2020,"Neither reactive hyperemia index nor pulse wave velocity were affected by either treatment ( P >0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12];  P =0.001 and 0.5 m/s [0.4-0.6];  P <0.001 for reactive hyperemia index and pulse wave velocity, respectively).","['adolescents with type 1 diabetes (AdDIT [Adolescent Type 1 Diabetes cardio-renal Intervention Trial', 'Adolescents With Type 1 Diabetes', 'high-risk adolescents', '215 lower-risk individuals', '158 high-risk participants']","['ACE inhibitors', 'placebo', 'ACE inhibitors and/or statins', 'ACE (angiotensin-converting enzyme) inhibitors and statins', 'Inhibitors and Statins', 'ACE (Angiotensin-Converting Enzyme']","['flow-mediated dilation', 'Endothelial function (flow-mediated dilation and reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity', 'albumin-creatinine ratio', 'endothelial dysfunction', 'reactive hyperemia index nor pulse wave velocity', 'endothelial function']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",158.0,0.579727,"Neither reactive hyperemia index nor pulse wave velocity were affected by either treatment ( P >0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12];  P =0.001 and 0.5 m/s [0.4-0.6];  P <0.001 for reactive hyperemia index and pulse wave velocity, respectively).","[{'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': 'From the Institute of Cardiovascular Science, University College London, United Kingdom (S.T.C., J.E.D.).'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': 'Department of Paediatrics, University of Cambridge, United Kingdom (M.L.M., D.B.D.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Benitez-Aguirre', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, University of Sydney, Camperdown, Australia (P.B.-A., K.C.D.).""}, {'ForeName': 'Fergus J', 'Initials': 'FJ', 'LastName': 'Cameron', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Australia (F.J.C.).'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales, Australia (M.E.C.).""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Couper', 'Affiliation': ""Departments of Endocrinology and Diabetes, Women's and Children's Hospital, Robinson Research Institute, University of Adelaide, Australia (J.J.C.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth (E.A.D., T.W.J.).'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ""Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom (R.N.D.).""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, ON, Canada (D.D., F.H.M.).'}, {'ForeName': 'Kim C', 'Initials': 'KC', 'LastName': 'Donaghue', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, University of Sydney, Camperdown, Australia (P.B.-A., K.C.D.).""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth (E.A.D., T.W.J.).'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, ON, Canada (D.D., F.H.M.).'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': 'Institute of Cellular Medicine (Diabetes), Faculty of Clinical Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (S.M.M.).'}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom (H.A.W.N.).'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, United Kingdom (M.L.M., D.B.D.).'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': 'From the Institute of Cardiovascular Science, University College London, United Kingdom (S.T.C., J.E.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15721']
1679,33100049,Effects of Intensive Systolic Blood Pressure Control on All-Cause Hospitalizations.,"Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control. We sought to determine whether the decrease in cardiovascular events seen with intensive blood pressure control is associated with an increased rate of other causes of hospitalization. This is a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial) in 9361 adult participants with hypertension and elevated cardiovascular risk. Participants were randomly assigned to an intensive or standard systolic blood pressure goal (<120 or <140 mm Hg, respectively). The primary outcome was hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events. After excluding hospitalizations linked to SPRINT primary events, there were 4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37). Equivalence testing shows that these hospitalization rates were statistically equivalent at the  P =0.05 level. Of those with hospitalizations, >1 hospitalization was seen in 38.8% of intensive arm participants and 41.9% of standard arm participants ( P =0.08). The mean cumulative count of nonprimary event hospitalizations was comparable between the two arms. The most common causes of hospitalization were cardiovascular (23.6%) followed by injuries, including bone and joint therapeutic procedures (15.7%), infections (12.0%), and nervous systems disorders (10.7%). No categories of hospitalization were statistically more common in the intensive arm compared with the standard arm. Thus, the decrease in cardiovascular events seen with intensive blood pressure control is not associated with an increased rate of other causes of hospitalization. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"['9361 adult participants with hypertension and elevated cardiovascular risk', '4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37']","['intensive or standard systolic blood pressure goal', 'Intensive Systolic Blood Pressure Control']","['hospitalization rates', 'bone and joint therapeutic procedures', 'categories of hospitalization', 'nervous systems disorders', 'mean cumulative count of nonprimary event hospitalizations', 'cardiovascular events', 'hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events', 'rate of cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948995', 'cui_str': 'Bone and joint therapeutic procedures'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",9361.0,0.192607,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"[{'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'From the Departments of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. (M.V.R., B.I.F., A.T.H.).'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Comeau', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (M.E.C., M.C.M., C.D.L.).'}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Marion', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (M.E.C., M.C.M., C.D.L.).'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'From the Departments of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. (M.V.R., B.I.F., A.T.H.).'}, {'ForeName': 'Amret T', 'Initials': 'AT', 'LastName': 'Hawfield', 'Affiliation': 'From the Departments of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. (M.V.R., B.I.F., A.T.H.).'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Langefeld', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (M.E.C., M.C.M., C.D.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15868']
1680,33109670,Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial.,"OBJECTIVE


To compare the effectiveness of the mobile e-Tabac Info Service (e-TIS) application (app) for helping adult smokers quit smoking with current practices.
DESIGN


Pragmatic randomised controlled trial with a 1-year follow-up (2017-2018).
SETTING


France, population-wide level.
PARTICIPANTS


2806 adult smokers who wished to quit smoking were recruited via the website of the French National Mandatory Health Insurance fund. Of them, 1400 were randomised to the e-TIS app arm and 1406 were randomised to the current practices arm (control).
INTERVENTION


The app involved personalised interactive contacts that included questionnaires, advice, activities and text messages. All contacts were individually tailored and based on each smoker's progress.In the control group, recommended practices for quitting smoking were described on a non-interactive website.
PRIMARY AND SECONDARY OUTCOMES MEASURES


The primary outcome was 7-day point prevalence abstinence (PPA) at 6 months. The secondary outcomes included continuous abstinence rates at 6 and 12 months, minimum 24-hour point abstinence at 3 months, minimum 30-day point abstinence at 12 months and number and duration of quit attempts.
RESULTS


There was no difference between the e-TIS and control arms for the primary outcome (12.6% vs 13.7% for 7-day PPA at 6 months, p=0.3949, intention-to-treat analysis). However, e-TIS participants with high levels of exposure to the app, which was defined by the completion of at least eight activities or questionnaires, showed higher rates of smoking cessation than the control participants (17.6% vs 12.9% for 7-day PPA at 6 months, p=0.0169, per-protocol analysis).
CONCLUSION


Use of the e-TIS app was not associated with a higher rate of smoking cessation. However, high level of exposure to the e-TIS app may have been more effective than current practices.
TRIAL REGISTRATION NUMBER


NCT02841683.",2020,"There was no difference between the e-TIS and control arms for the primary outcome (12.6% vs 13.7% for 7-day PPA at 6 months, p=0.3949, intention-to-treat analysis).","['adult smokers quit smoking with current practices', 'smoking cessation', '2806 adult smokers who wished to quit smoking were recruited via the website of the French National Mandatory Health Insurance fund', 'France, population-wide level']","['mobile e-Tabac Info Service (e-TIS) application (app', 'current practices arm (control', 'e-Tabac Info Service application']","['rates of smoking cessation', 'continuous abstinence rates at 6 and 12 months, minimum 24-hour point abstinence at 3 months, minimum 30-day point abstinence at 12 months and number and duration of quit attempts', '7-day point prevalence abstinence (PPA', 'rate of smoking cessation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0045439', 'cui_str': '2,4,6-triiodo-3-acetamidobenzoic acid (N-cyclohexylcarbamyloxy)ethyl ester'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",2806.0,0.248753,"There was no difference between the e-TIS and control arms for the primary outcome (12.6% vs 13.7% for 7-day PPA at 6 months, p=0.3949, intention-to-treat analysis).","[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Affret', 'Affiliation': 'Population Health Research Center, UMR 1219, CIC-EC 1401, Université Bordeaux, Bordeaux, Nouvelle Aquitaine, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Luc', 'Affiliation': 'UMDS, CHRU, Nancy, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baumann', 'Affiliation': 'UMDS, CHRU, Nancy, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': ""Caisse nationale de l'assurance maladie, Paris, Île-de-France, France.""}, {'ForeName': 'Anne-Laurence', 'Initials': 'AL', 'LastName': 'Le Faou', 'Affiliation': 'Department of psychiatry and addictology, HEGP, AP-HP, Pais, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pasquereau', 'Affiliation': 'Santé publique France, Saint-Maurice, Île-de-France, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Arwidson', 'Affiliation': 'Santé publique France, Saint-Maurice, Île-de-France, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Alla', 'Affiliation': 'Population Health Research Center, UMR 1219, CIC-EC 1401, Université Bordeaux, Bordeaux, Nouvelle Aquitaine, France francois.alla@u-bordeaux.fr.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cambon', 'Affiliation': 'Population Health Research Center, UMR 1219, CIC-EC 1401, Université Bordeaux, Bordeaux, Nouvelle Aquitaine, France.'}]",BMJ open,['10.1136/bmjopen-2020-039515']
1681,33109679,Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial.,"INTRODUCTION


Despite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.
METHODS AND ANALYSIS


This single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10-20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.
TRIAL REGISTRATION NUMBER


SLCTR/2018/024; Pre-results.",2020,Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans.,"['Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia', 'transfusion-dependent β-thalassaemia', 'Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka']","['placebo', 'Hydroxyurea', 'oral hydroxyurea', 'hydroxyurea without its active ingredient']","['efficacy and safety', 'Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects', 'Efficacy and safety', 'quality of life and shorter life spans', 'blood transfusions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.540496,Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans.,"[{'ForeName': 'Nirmani', 'Initials': 'N', 'LastName': 'Yasara', 'Affiliation': 'Department of Paediatrics, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Nethmi', 'Initials': 'N', 'LastName': 'Wickramarathne', 'Affiliation': 'Department of Paediatrics, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Chamila', 'Initials': 'C', 'LastName': 'Mettananda', 'Affiliation': 'Department of Pharmacology, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Aresha', 'Initials': 'A', 'LastName': 'Manamperi', 'Affiliation': 'Molecular Medicine Unit, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Premawardhena', 'Affiliation': 'Department of Medicine, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Sachith', 'Initials': 'S', 'LastName': 'Mettananda', 'Affiliation': 'Department of Paediatrics, University of Kelaniya, Ragama, Sri Lanka sachith.mettananda@kln.ac.lk.'}]",BMJ open,['10.1136/bmjopen-2020-041958']
1682,33109706,Clinical staging in amyotrophic lateral sclerosis: analysis of Edaravone Study 19.,"OBJECTIVE


This was a post hoc analysis of the Edaravone Phase III Study MCI186-19 ('Study 19') to examine the utility of clinical staging systems as end points in clinical trials in amyotrophic lateral sclerosis (ALS).
METHODS


Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised item scores from Study 19 were retrospectively mapped to King's stage and Milano-Torino staging (MiToS) stage. We assessed the percentage of patients who experienced progression in King's and MiToS stages during Study 19. We also assessed disease progression in subgroups of patients according to baseline King's stage.
RESULTS


During double-blind treatment, the percentage of patients who experienced a progression in King's stage was lower for edaravone (42.0%, 95% CI 30.4% to 53.6%) than placebo (55.9%, 95% CI 44.1% to 67.6%). The most pronounced effect was noted among patients who were in stage 1 and was maintained throughout open-label treatment. An analysis of a ≥2-stage progression in MiToS stage showed no difference between treatment arms during double-blind treatment, but during the open-label period, more rapid progression was noted among patients in the placebo-edaravone arm than among those in the edaravone-edaravone arm (log-rank test, p<0.001).
CONCLUSIONS


The King's and MiToS staging systems provided utility in assessing clinical progression in Edaravone Study 19. These findings may support the use of staging systems as end points in ALS clinical trials and to understand the timing of benefit as measured by these scales.",2020,"During double-blind treatment, the percentage of patients who experienced a progression in King's stage was lower for edaravone (42.0%, 95% CI 30.4% to 53.6%) than placebo (55.9%, 95% CI 44.1% to 67.6%).","[""subgroups of patients according to baseline King's stage"", 'amyotrophic lateral sclerosis (ALS', 'amyotrophic lateral sclerosis', ""Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised item scores from Study 19 were retrospectively mapped to King's stage and Milano-Torino staging (MiToS) stage"", ""patients who experienced progression in King's and MiToS stages during Study 19""]","['placebo', 'placebo-edaravone']","['disease progression', ""progression in King's stage"", 'rapid progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",,0.203965,"During double-blind treatment, the percentage of patients who experienced a progression in King's stage was lower for edaravone (42.0%, 95% CI 30.4% to 53.6%) than placebo (55.9%, 95% CI 44.1% to 67.6%).","[{'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Al-Chalabi', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Maurice Wohl Clinical Neuroscience Institute, King's College London, London, UK.""}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Chiò', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, ALS Centre, University of Turin and Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Merrill', 'Affiliation': 'Mitsubishi Tanabe Pharma America, Inc, Jersey City, New Jersey, USA.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Oster', 'Affiliation': 'Policy Analysis Inc, Brookline, Massachusetts, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bornheimer', 'Affiliation': 'Policy Analysis Inc, Brookline, Massachusetts, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Agnese', 'Affiliation': 'Mitsubishi Tanabe Pharma America, Inc, Jersey City, New Jersey, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Apple', 'Affiliation': 'Mitsubishi Tanabe Pharma America, Inc, Jersey City, New Jersey, USA stephen_apple@mt-pharma-us.com.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323271']
1683,33109739,Breast Cancer Index predicts extended endocrine benefit to individualize selection of HR+ early stage breast cancer patients for 10 years of endocrine therapy.,"PURPOSE


Individualized selection of patients with early stage hormone receptor positive (HR+) breast cancer for extended endocrine therapy (EET) are required to balance modest gains in outcome with toxicities of prolonged use. This study examined the Breast Cancer Index (BCI) [HOXB13/IL17BR ratio (H/I)] as a predictive biomarker of EET benefit in patients from the Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial.
EXPERIMENTAL DESIGN


BCI was tested in primary tumor specimens from 908 patients randomized to receive 2.5 vs 5 years of extended letrozole. The primary endpoint was recurrence-free interval (RFI). Cox models and likelihood ratios tested the interaction between EET and BCI (H/I).
RESULTS


BCI (H/I)-High significantly predicted benefit from extended letrozole in the Overall cohort (HR 0.42, 95% CI 0.21-0.84; P=0.011) and Any AI subset (HR 0.34, 0.16-0.73; P=0.004), whereas BCI (H/I)-Low patients did not derive significant benefit (HR 0.95, 0.58-1.56; P=0.84, HR 0.90, 0.53-1.55; P=0.71, respectively); treatment to biomarker interaction was significant (P=0.045, P=0.025, respectively). BCI identified ~50% of patients with clinically high-risk disease that did not benefit, and with clinically low-risk disease that derived significant benefit, from an additional 2.5 years of EET.
CONCLUSIONS


BCI (H/I) predicted preferential benefit from 5 vs 2.5 years of EET and identified patients with improved outcomes from completing 10 years of adjuvant endocrine therapy. Findings expand the clinical utility of BCI (H/I) to a broader range of patients and beyond prognostic risk factors as a predictive endocrine response biomarker for early stage HR+ breast cancer.",2020,Findings expand the clinical utility of BCI (H/I) to a broader range of patients and beyond prognostic risk factors as a predictive endocrine response biomarker for early stage HR+ breast cancer.,"['HR+ early stage breast cancer patients for 10 years of endocrine therapy', 'patients with early stage hormone receptor positive (HR+) breast cancer for extended', 'BCI was tested in primary tumor specimens from 908 patients randomized to receive 2.5 vs 5 years of', 'patients from the Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial']","['endocrine therapy (EET', 'letrozole', 'extended letrozole']","['HOXB13/IL17BR ratio (H/I', 'Breast Cancer Index (BCI', 'recurrence-free interval (RFI', 'BCI']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",908.0,0.0385669,Findings expand the clinical utility of BCI (H/I) to a broader range of patients and beyond prognostic risk factors as a predictive endocrine response biomarker for early stage HR+ breast cancer.,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Noordhoek', 'Affiliation': 'Surgery, Leiden University Medical Center.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Treuner', 'Affiliation': 'Clinical Development, Biotheranostics, Inc.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics, bioTheranostics, Inc.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Biotheranostics, Inc.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Duijm-de Carpentier', 'Affiliation': 'Surgery, LUMC.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Schnabel', 'Affiliation': 'Medical & Scientific Affairs, bioTheranostics, Inc.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Liefers', 'Affiliation': 'surgery, LUMC G.J.Liefers@lumc.nl.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2737']
1684,33110044,"The effect of Fennel seed powder on estradiol levels, menopausal symptoms, and sexual desire in postmenopausal women.","OBJECTIVES


The present study was designed to determine the effect of Fennel seed powder on menopausal symptoms, sexual desire, and serum estradiol levels in postmenopausal women.
METHODS


The present study was conducted on 80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran. Participants were randomized into equal intervention and control (control) groups. The intervention and control groups received four capsules of Fennel seed powder (2 gr) and starch-containing capsules (2 gr) daily over 8 weeks, respectively. Menopausal symptoms and sexual desire of the participants were evaluated using both the menopausal Kupperman index and Hurlbert index of sexual desire. The questionnaires were completed at baseline, week 4 and week 8 of the study by the participants. The serum estradiol levels were measured at baseline and also at the end of the study. The Chi-square test, independent t test, and repeated-measures analysis of variance were used to analyze the data.
RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05). Treatment with Fennel seed did not significantly enhance the participants sexual desire (P > 0.05). The estradiol levels declined in the intervention (from 60.4 ± 43.4 to 52.6 ± 25.7) and control groups (from 55.1 ± 22.4 to 39.9 ± 26.9). However, this decrease was lower in the intervention group than in the control group. The intergroup differences were not statistically significant (P > 0.05).
CONCLUSIONS


The results of the present study indicated that daily use of Fennel seed significantly improved menopausal symptoms in postmenopausal women over 8 weeks, though its effect on estradiol levels and sexual desire was not significant. Further studies with a larger sample size and longer duration are needed to verify these findings.",2020,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","['80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran', 'postmenopausal women']","['Fennel seed powder', 'four capsules of Fennel seed powder (2 gr) and starch-containing capsules']","['estradiol levels', 'estradiol levels, menopausal symptoms, and sexual desire', 'menopausal Kupperman index and Hurlbert index of sexual desire', 'menopausal symptoms', 'participants sexual desire', 'serum estradiol levels', 'Menopausal symptoms and sexual desire', 'Menopausal symptoms score', 'estradiol levels and sexual desire', 'menopausal symptoms, sexual desire, and serum estradiol levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0453256', 'cui_str': 'Fennel seed preparation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0505872,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hosseininik', 'Affiliation': 'School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Ardashir', 'Initials': 'A', 'LastName': 'Afrasiabifar', 'Affiliation': 'Professor of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Hosseininik', 'Affiliation': 'Petroleum Industry Health Organization, Hospital Gachsaran Oil Industry (Besat), Ministry of Petroleum, Tehran, Iran.'}, {'ForeName': 'Seyedeh Marzieh', 'Initials': 'SM', 'LastName': 'Tabatabaei', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Nazafarin', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001604']
1685,33110312,"Comparative Evaluation of Efficacy of 4% Tulsi Extract ( Ocimum sanctum ), Fluoridated and Placebo Dentifrices against Gingivitis and Plaque among 14-15 years School Children in Davangere City, India - A Triple Blinded Randomized Clinical Trial.","Context


Gingivitis is the most prevalent periodontal disease among adolescents. The most important factor associated with gingivitis is plaque accumulation. Mechanical plaque control through tooth brushing and mouth rinsing are the most commonly used preventive methods.
Aims


This study aims to assess and compare the antiplaque and antigingivitis effect of 4% Tulsi leaf extract dentifrice, fluoridated and placebo dentifrice (PD) among 14-15-year-old school children in Davangere city.
Materials and Methods


A triple blinded concurrent parallel trial. A sample of 84 participants with a baseline mean gingival index score of at least 1.0 and mean plaque index score of at least 1.5 were randomly selected. Participants were divided into three groups by block randomization and concealed random allocation method was used to distribute dentifrices. Postassessment of plaque and gingivitis was done on the 21 st  day.
Statistical Analysis Used


Wilcoxon signed rank test for within group comparison and Kruskal-Wallis ANOVA for intergroup comparison was used.
Results


Significant reduction in the plaque and gingival scores between the groups was observed on the 21 st  day ( P  = 0.001). Maximum reduction in gingivitis ( P  = 0.001) and dental plaque ( P  = 0.01) was seen in 4% tulsi dentifrice group compared to PD.
Conclusion


Antiplaque and antigingivitis efficacy of 4% tulsi and commercially available fluoridated dentifrice remained the same after 21 days.",2020,"Maximum reduction in gingivitis ( P  = 0.001) and dental plaque ( P  = 0.01) was seen in 4% tulsi dentifrice group compared to PD.
","['84 participants with a baseline mean gingival index score of at least 1.0 and mean plaque index score of at least 1.5 were randomly selected', '14-15 years School Children in Davangere City, India ', '14-15-year-old school children in Davangere city']","['4% Tulsi Extract ( Ocimum sanctum ), Fluoridated and Placebo Dentifrices', '4% Tulsi leaf extract dentifrice, fluoridated and placebo dentifrice (PD', 'fluoridated dentifrice']","['dental plaque', 'plaque and gingival scores', 'Postassessment of plaque and gingivitis', 'Maximum reduction in gingivitis']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1483721', 'cui_str': 'Ocimum tenuiflorum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",84.0,0.14137,"Maximum reduction in gingivitis ( P  = 0.001) and dental plaque ( P  = 0.01) was seen in 4% tulsi dentifrice group compared to PD.
","[{'ForeName': 'Bhuvaneshwari Gangadharamurthy', 'Initials': 'BG', 'LastName': 'Nadar', 'Affiliation': 'Department of Public Health Dentistry, Bapuji Dental College and Hospital, Bangalore, Karnataka, India.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Usha', 'Affiliation': 'Department of Public Health Dentistry, Bapuji Dental College and Hospital, Bangalore, Karnataka, India.'}, {'ForeName': 'Nagesh', 'Initials': 'N', 'LastName': 'Lakshminarayan', 'Affiliation': 'Department of Public Health Dentistry, Dayanand Sagar Dental College and Hospital, Bangalore, Karnataka, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_109_19']
1686,33110324,Caries Activity and Ph Level Changes after Fluoride Varnish and Casein Phosphopeptides-Amorphous Calcium Phosphate Application on Children's Saliva.,"Background


Caries is a disease affecting the hard tissue of the tooth wherein the demineralization process caused by  Streptococcus mutans  decreases saliva pH faster than the remineralization process can maintain it. Topical fluoridation, such as fluoride varnish and casein phosphopeptides-amorphous calcium phosphate (CPP-ACP) is the most common preventive therapy for the disease.
Aims


The aim of this study is to assess the difference between fluoride varnish and CPP-ACP in reducing saliva pH and caries activity.
Materials and Methods


This is an experimental study with a sample population of 60 children (aged 8-9 years old), divided into two groups of 30. Group 1 was treated with fluoride varnish, Group 2 with CPP-ACP. A  t -test was used to measure the effects of the different treatments.
Results


The result showed that the average difference in saliva pH before and after application was -0.12933 in Group 1 and -0.14033 in Group 2 ( P  = 0.256). The average difference in caries activity before and after application was 3.189 log colony-forming units (CFUs)/mL in Group 1 and 2.237 log CFUs/mL in Group 2 ( P  = 0.275).
Conclusion


The most effective treatment for increasing saliva pH and reducing caries activity can be achieved by using the varnish for 1 month. However, there is no difference between fluoride varnish and CPP-ACP with regard to altering saliva pH and reducing caries activity statistically. Future study is needed to explore this result.",2020,The result showed that the average difference in saliva pH before and after application was -0.12933 in Group 1 and -0.14033 in Group 2 ( P  = 0.256).,"[""Children's Saliva"", 'sample population of 60 children (aged 8-9 years old']","['fluoride varnish and casein phosphopeptides-amorphous calcium phosphate (CPP-ACP', 'fluoride varnish and CPP-ACP', 'fluoride varnish', 'CPP-ACP', 'Fluoride Varnish and Casein Phosphopeptides-Amorphous Calcium Phosphate Application']","['saliva pH and caries activity', 'Caries Activity and Ph Level Changes', 'saliva pH', 'caries activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.0353628,The result showed that the average difference in saliva pH before and after application was -0.12933 in Group 1 and -0.14033 in Group 2 ( P  = 0.256).,"[{'ForeName': 'Anie', 'Initials': 'A', 'LastName': 'Apriani', 'Affiliation': 'Post Graduate Student Faculty of Dentistry Trisakti University, Jakarta, Indonesia.'}, {'ForeName': 'Armelia Sari', 'Initials': 'AS', 'LastName': 'Widyarman', 'Affiliation': 'Department Head of Microbiology, Faculty of Dentistry, Trisakti University, Jakarta, Indonesia.'}, {'ForeName': 'E Arlia', 'Initials': 'EA', 'LastName': 'Budiyanti', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Trisakti University, Jakarta, Indonesia.'}, {'ForeName': 'Boedi Oetomo', 'Initials': 'BO', 'LastName': 'Roeslan', 'Affiliation': 'Department of Oral Biology, Faculty of Dentistry, Trisakti University, Jakarta, Indonesia.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_167_20']
1687,33110349,Effectiveness of a School-Based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Quasi-Experimental Controlled Trial.,"Objective


To evaluate the effect of a school-based tobacco program in preventing initiation of tobacco use among adolescents in Saudi Arabia.
Methods


We used a quasi-experimental controlled design. Four intervention and four control schools were selected from the regional education registry. A baseline questionnaire was administered to all grade 7 students before implementing the tobacco prevention program, Dentists Fighting Nicotine Dependence (DFND). The intervention group (n =379) received the DFND program whereas the control group (n = 255) received the regular tobacco program administered by the Department of Education. The program was delivered by trained health educators over 5 weeks. Pre- and post-test surveys (immediate and 2-year post-intervention) were collected. Study outcomes were current tobacco use, tobacco knowledge, attitude towards not using tobacco, and perceived behavioral control (PBC) of tobacco use. Covariates included sex, parent education, academic performance, absenteeism, student allowance, and religiosity. Data were analyzed using a two-level hierarchical mixed models.
Results


In the immediate post-test, 597 participants (intervention, n = 366; control, n = 231) were surveyed. There was no difference in tobacco use between intervention and control schools, however, the intervention group had significantly higher mean scores for knowledge (β = 1.27, SE = 0.27,  P  < .01) and attitude toward not using tobacco (β = 5.17, SE = 2.48,  P  < .05) after adjusting for covariates. At 2-year post-intervention, 463 participants (intervention, n = 289; control, n = 173) were surveyed. There were no differences in tobacco use, knowledge, attitude or PBC between intervention and control groups.
Conclusions


Our program did not impact tobacco use. In the short-term, the program significantly improved knowledge and attitude towards not using tobacco. These effects decayed 2 years post-intervention without additional programming. Increasing the effectiveness of DFND may be achieved by expanding curriculum content and practice time throughout the school years and by targeting high-risk adolescents within the program.",2020,"There was no difference in tobacco use between intervention and control schools, however, the intervention group had significantly higher mean scores for knowledge (β = 1.27, SE = 0.27,  P  < .01) and attitude toward not using tobacco (β = 5.17, SE = 2.48,  P  < .05) after adjusting for covariates.","['597 participants (intervention, n = 366; control, n = 231) were surveyed', 'Middle School Students in Saudi Arabia', 'adolescents in Saudi Arabia', '463 participants (intervention, n = 289; control, n = 173) were surveyed']","['school-based tobacco program', 'School-Based Tobacco Prevention Program', 'DFND program', 'regular tobacco program administered by the Department of Education']","['tobacco use', 'knowledge and attitude', 'mean scores for knowledge', 'sex, parent education, academic performance, absenteeism, student allowance, and religiosity', 'current tobacco use, tobacco knowledge, attitude towards not using tobacco, and perceived behavioral control (PBC) of tobacco use', 'tobacco use, knowledge, attitude or PBC']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0424324', 'cui_str': 'Fighting'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0681189', 'cui_str': 'Religiosity'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}]",231.0,0.028732,"There was no difference in tobacco use between intervention and control schools, however, the intervention group had significantly higher mean scores for knowledge (β = 1.27, SE = 0.27,  P  < .01) and attitude toward not using tobacco (β = 5.17, SE = 2.48,  P  < .05) after adjusting for covariates.","[{'ForeName': 'Dania E', 'Initials': 'DE', 'LastName': 'Al Agili', 'Affiliation': 'Department of Dental Public Health, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Hamisu M', 'Initials': 'HM', 'LastName': 'Salihu', 'Affiliation': 'Department of Family and Community Medicine, Baylor College of Medicine, Houston, TX, USA.'}]",Tobacco use insights,['10.1177/1179173X20953403']
1688,33110670,"Knowledge, Attitude and Practice on Diabetic Wound Care Management among Healthcare Professionals and Impact from A Short Course Training in Sabah, Borneo.","Objective


Healthcare professionals with an advanced level of knowledge and skills on diabetic wound care management are needed to effectively manage complex wounds. This study aimed to determine the effects of an educational intervention to enhance the management of wound care among healthcare professionals.
Method


This study was part of a quasi-experimental pre-post research design where 82 healthcare professionals were recruited and assigned to intervention and control groups. The participants in the intervention group attended two days of educational intervention training on diabetic wound care management, while there was no intervention in the control group. A questionnaire on knowledge, attitude, and practice was applied before and one-month post-intervention to both groups.
Results


Pre-test resulted in a low level of knowledge 72.1% and 74.4%, negative level of attitude 67.4% and 66.7%, and a moderate level of practice 79.1% and 76.9% in both intervention and control groups respectively. Post-test resulted in increasing levels of knowledge (76.7%), positive attitude (100%), and practice (76.7%) in the intervention group. At the same time, there was no significant change in the control group. Repeated Measure ANOVA for within-subject and between-subject effects resulted in a statistically significant p-value of 0.001 for knowledge, attitude, and practice after the educational intervention.
Conclusion


Health professionals have only a moderate level of knowledge on diabetic wound care management. It is important to improve this level by specific trainings and by using a good training module.",2020,"Post-test resulted in increasing levels of knowledge (76.7%), positive attitude (100%), and practice (76.7%) in the intervention group.",['82 healthcare professionals'],"['educational intervention training', 'educational intervention']","['levels of knowledge', 'positive attitude', 'negative level of attitude']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0178013,"Post-test resulted in increasing levels of knowledge (76.7%), positive attitude (100%), and practice (76.7%) in the intervention group.","[{'ForeName': 'Melvin Ebin', 'Initials': 'ME', 'LastName': 'Bondi', 'Affiliation': 'Putatan Health Clinic, Department of Primary Health Care, Putatan, Sabah, Malaysia.'}, {'ForeName': 'Syed Sharizman Syed Abdul', 'Initials': 'SSSA', 'LastName': 'Rahim', 'Affiliation': 'Universiti Malaysia Sabah, Department of Community and Family Medicine, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Avoi', 'Affiliation': 'University of Malaysia Sabah, Department of Community and Family Medicine, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Hayati', 'Affiliation': 'University of Malaysia Sabah, Department of Surgery, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Fatimah', 'Initials': 'F', 'LastName': 'Ahmedy', 'Affiliation': 'University of Malaysia Sabah, Department of Medical Education, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Azizan', 'Initials': 'A', 'LastName': 'Omar', 'Affiliation': 'University of Malaysia Sabah, Department of Community and Family Medicine, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Mohammad Saffree', 'Initials': 'MS', 'LastName': 'Jeffree', 'Affiliation': 'University of Malaysia Sabah, Department of Community and Family Medicine, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Awang Setia', 'Initials': 'AS', 'LastName': 'Musleh', 'Affiliation': 'University of Malaysia Sabah, Department of Community and Family Medicine, Kota Kinabalu, Sabah, Malaysia.'}]",Medeniyet medical journal,['10.5222/MMJ.2020.02929']
1689,33110692,INFLUENCE OF AN ACUTE BOUT OF SELF-MYOFASCIAL RELEASE ON KNEE EXTENSION FORCE OUTPUT AND ELECTRO-MECHANICAL ACTIVATION OF THE QUADRICEPS.,"Background


In contrast to static stretching (SS), previous research has demonstrated increases in flexibility after an acute bout of self-myofascial release (SMR) without any subsequent decreases in force output. Previous research has utilized measures of surface electromyography (sEMG) and mechanomyography (MMG) to examine the influence of SS on the electrical and mechanical processes of muscle activation, respectively. However, there is a lack of research examining the potential changes in electro-mechanical muscle activation post-SMR.
Purpose


To examine the influence of SMR, via an acute bout of foam rolling (FR) to the vastus lateralis (VL), on the expression of knee extension force output and the inter-muscular electro-mechanical activation of the quadriceps musculature.
Study Design


Randomized crossover trial.
Methods


Twenty (10 males, 10 females) recreationally-active participants with prior FR experience completed both SMR and control (CON) testing protocols during separate testing sessions that were conducted in a randomized order 48 hours apart. During the SMR protocol, participants performed 3 sets of 60 seconds of FR over the VL portion of their quadriceps musculature, with 60 seconds of rest between sets. During the CON protocol, participants quietly sat upright for 10 minutes. Peak knee extension force output -(Force peak ) data, as well as sEMG and MMG data from the VL and the rectus femoris (RF) were collected during maximal voluntary isometric contractions (MVICs) before and after both testing protocols. Root mean square sEMG and MMG amplitudes were calculated to represent electro-mechanical muscle activation of the VL (VL-sEMG RMS , VL-MMG RMS ) and RF (RF-sEMG RMS , RF-MMG RMS ) musculature.
Results


Repeated measures analyses of variance (RM ANOVAs) identified a significant ( p  < 0.05) increase in Force peak  within the SMR protocol among males, but no change among females. No statistically significant changes in any electro-mechanical muscle activation measures were identified pre-to-post-SMR within either sex.
Conclusion


In contrast to the SS literature body, these results suggest that SMR does not influence the electro-mechanical aspects of muscle activation during MVICs. These results provide support for the absence of decreases in force output post-SMR, but further examination regarding the potential muscle mass influence of SMR on electro-mechanical muscle function remains warranted.
Level of Evidence


2c.",2020,"No statistically significant changes in any electro-mechanical muscle activation measures were identified pre-to-post-SMR within either sex.
","['Methods\n\n\nTwenty (10 males, 10 females) recreationally-active participants with prior FR experience completed both SMR and control (CON) testing protocols during separate testing sessions']",['static stretching (SS'],"['Force peak', 'electro-mechanical muscle activation measures', 'Root mean square sEMG and MMG amplitudes', 'electro-mechanical muscle activation of the VL (VL-sEMG RMS , VL-MMG RMS ) and RF (RF-sEMG RMS , RF-MMG RMS ) musculature']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]",,0.0233249,"No statistically significant changes in any electro-mechanical muscle activation measures were identified pre-to-post-SMR within either sex.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cornell', 'Affiliation': ''}, {'ForeName': 'Kyle T', 'Initials': 'KT', 'LastName': 'Ebersole', 'Affiliation': ''}]",International journal of sports physical therapy,['10.26603/ijspt20200732']
1690,33110754,Comparison of endpoint of subjective cycloplegic refraction with artificial aperture and post-mydriatic test among adults with refractive error.,"PURPOSE


There is a need to understand the requirement for the post-mydriatic test (PMT) among adults for the final prescription of spectacles as this test increases the cost of eye care and causes inconvenience to the patient because of the additional visit to an eye care practitioner. We aim to compare the cycloplegic subjective refraction using apertures of various sizes and PMT in an adult population.
METHODS


This prospective crossover study was conducted under standard settings in an eye clinic. Adult individuals between 18 and 35 years of with emmetropia and various degrees of ametropia participated in this study. Individuals with known ocular pathology were excluded. Non-cycloplegic objective refraction was performed followed by subjective refraction. Cycloplegic objective refraction was performed followed by subjective refraction with custom designed artificial apertures. After a washout period of cycloplegic, PMT was performed. The distribution of data was tested using the Kolmogorov-Smirnov test. Depending on the distribution of the data, either parametric or nonparametric test was done.
RESULTS


Fifty-nine eyes of thirty individuals with a mean (±SD) age of 23(±4) years with a male: female ratio of 1:4 participated in this study. A comparison of measures of PMT and subjective refraction with 2, 3, 4, 5, and 6 mm aperture under cycloplegic effect using the Friedman test rendered a Chi square value (df = 5) of 1.92 which was not statistically different ( P  = 0.86).
CONCLUSION


Performing subjective refraction with an appropriate spherical and cylindrical endpoint under cycloplegic effect with appropriate aperture overcomes the necessity of PMT.",2020,"A comparison of measures of PMT and subjective refraction with 2, 3, 4, 5, and 6 mm aperture under cycloplegic effect using the Friedman test rendered a Chi square value (df = 5) of 1.92 which was not statistically different ( P  = 0.86).
","['years with a male: female ratio of 1:4 participated in this study', 'Adult individuals between 18 and 35 years of with emmetropia and various degrees of ametropia participated in this study', 'adult population', 'adults with refractive error', 'Fifty-nine eyes of thirty individuals with a mean (±SD) age of 23(±4', 'Individuals with known ocular pathology']",['artificial aperture and post-mydriatic test'],"['cycloplegic subjective refraction', 'PMT and subjective refraction']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1527310', 'cui_str': 'Ametropia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0430898', 'cui_str': 'Mydriatic test'}]","[{'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0430898', 'cui_str': 'Mydriatic test'}]",30.0,0.0391774,"A comparison of measures of PMT and subjective refraction with 2, 3, 4, 5, and 6 mm aperture under cycloplegic effect using the Friedman test rendered a Chi square value (df = 5) of 1.92 which was not statistically different ( P  = 0.86).
","[{'ForeName': 'Nagarajan', 'Initials': 'N', 'LastName': 'Theruveethi', 'Affiliation': 'Department of Optometry, Manipal College of Health Professions, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ramesh S', 'Initials': 'RS', 'LastName': 'Ve', 'Affiliation': 'Department of Optometry, Manipal College of Health Professions, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Krithica', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Optometry, Manipal College of Health Professions, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Taiwan journal of ophthalmology,['10.4103/tjo.tjo_36_19']
1691,33110804,Controlling the anxiety in Iranian pregnant women at risk of preterm labor by undergoing the counseling group intervention.,"Objective


The effect of a new, structured group training program on the anxiety reduction in Iranian pregnant women at risk of preterm labor (PTL) was assessed.
Design


A randomized controlled clinical trial.
Setting


The prenatal care center in the Gynecology Clinic of University Hospital.
Population


72 Iranian pregnant women at risk of PTL with a gestational age of 24-28 weeks.
Methods


Several trained research nurses presented group educational counseling sessions for 6 weeks based on the integration of psychological instructions and interactive lectures for the intervened group ( n  = 36). Pregnant women in the control group ( n  = 36) only received routine pregnancy care.
Main Outcome Measures


The completion of pregnancy-related anxiety questionnaire (PRAQ) for Iranian pregnant women at risk of PTL in the intervention (before and after 6-week counseling, and 1-month post-counseling) and control (before, and on the 6 th  and 10 th  week after the study) groups.
Results


There was a significant difference in the mean anxiety score between the intervention (3.45 ± 0.75) and control (3.01 ± 0.34) groups before the group educational counseling sessions. After this intervention, a significant reduction in the mean anxiety scores of intervened pregnant women (2.48 ± 0.32) compared to the control (2.68 ± 0.81) was found. This decrease in mean anxiety score after the 1-month post-counseling was more pronounced than the 6 th  week after the study onset ( P  < 0.001). Low anxiety scores in the intervention group over time were also maintained.
Conclusions


Implementing the group educational counseling sessions is recommended as a complementary, effective, and noninvasive intervention to efficiently control the anxiety in pregnant women at risk of PTL.",2020,There was a significant difference in the mean anxiety score between the intervention (3.45 ± 0.75) and control (3.01 ± 0.34) groups before the group educational counseling sessions.,"['Iranian pregnant women at risk of preterm labor by undergoing the counseling group intervention', 'Iranian pregnant women at risk of', '72 Iranian pregnant women at risk of PTL with a gestational age of 24-28 weeks', 'pregnant women at risk of PTL', 'Iranian pregnant women at risk of preterm labor', 'Pregnant women in the control group ( n  = 36) only received', 'Setting\n\n\nThe prenatal care center in the Gynecology Clinic of University Hospital']","['routine pregnancy care', 'PTL', 'new, structured group training program']","['completion of pregnancy-related anxiety questionnaire (PRAQ', 'Low anxiety scores', 'mean anxiety scores', 'anxiety reduction', 'mean anxiety score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",72.0,0.0377551,There was a significant difference in the mean anxiety score between the intervention (3.45 ± 0.75) and control (3.01 ± 0.34) groups before the group educational counseling sessions.,"[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Bazrafshan', 'Affiliation': 'School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Kheirkhah', 'Affiliation': 'Nursing Care Research Center, Midwifery and Reproductive Health Department, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Inanlou', 'Affiliation': 'Nursing Care Research Center, Midwifery and Reproductive Health Department, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Rasouli', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1227_19']
1692,33110944,A multi centre randomized open label trial of chloroquine for the treatment of adults with SARS-CoV-2 infection in Vietnam.,"Background : COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19. We hypothesise that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid decline of viral load in throat/nose swabs. This viral attenuation should be associated with improved patient outcomes.  Method : The study will start with a 10-patient prospective observational pilot study following the same entry and exclusion criteria as for the randomized trial and undergoing the same procedures. The main study is an open label, randomised, controlled trial with two parallel arms of standard of care (control arm) versus standard of care with 10 days of chloroquine (intervention arm) with a loading dose over the first 24 hours, followed by 300mg base orally once daily for nine days. The study will recruit patients in three sites in Ho Chi Minh City, Vietnam: the Hospital for Tropical Diseases, the Cu Chi Field Hospital, and the Can Gio COVID hospital. The primary endpoint is the time to viral clearance from throat/nose swab, defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs. Viral presence will be determined using RT-PCR to detect SARS-CoV-2 RNA.  Discussion:  The results of the study will add to the evidence-based guidelines for management of COVID-19. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19.  Trial registration:  Clinicaltrials.gov NCT04328493 31/03/2020.",2020,This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19.,"['patients with COVID-19', 'adults with SARS-CoV-2 infection in Vietnam', 'hospitalised people with COVID-19']","['standard of care (control arm) versus standard of care with 10 days of chloroquine', 'chloroquine', ' ']","['time to viral clearance from throat/nose swab, defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.138562,This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19.,"[{'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Kestelyn', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thi Phuong', 'Initials': 'NTP', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Yen', 'Initials': 'Y', 'LastName': 'Lam Minh', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Le Manh', 'Initials': 'LM', 'LastName': 'Hung', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Minh', 'Initials': 'NM', 'LastName': 'Quan', 'Affiliation': 'Thu Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Dung', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Ngoc Quang', 'Initials': 'NNQ', 'LastName': 'Minh', 'Affiliation': ""Children's Hospital 1, Ho Chi Minh City, Vietnam.""}, {'ForeName': 'Tran Chanh', 'Initials': 'TC', 'LastName': 'Xuan', 'Affiliation': 'Cu Chi field hospital, Cu Chi, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Phong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Ninh Thi Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Nguyen Hoang', 'Initials': 'TNH', 'LastName': 'Tu', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Le Thanh Hoang', 'Initials': 'LTH', 'LastName': 'Nhat', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Truong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dinh Nguyen Huy', 'Initials': 'DNH', 'LastName': 'Man', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Huynh Phuong', 'Initials': 'HP', 'LastName': 'Thao', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nghiêm My', 'Initials': 'NM', 'LastName': 'Ngoc', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thanh', 'Initials': 'VT', 'LastName': 'Lam', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Huynh Hong', 'Initials': 'HH', 'LastName': 'Phat', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phan Minh', 'Initials': 'PM', 'LastName': 'Phuong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thi Nhi', 'Initials': 'VTN', 'LastName': 'Ha', 'Affiliation': 'Administration of Science, Technology and Training (ASTT), Ministry of Health, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Ngo', 'Initials': 'NN', 'LastName': 'Quang', 'Affiliation': 'Administration of Science, Technology and Training (ASTT), Ministry of Health, Hanoi, Vietnam.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Tran Tinh', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Le Van', 'Initials': 'LV', 'LastName': 'Tan', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Day', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Wellcome open research,['10.12688/wellcomeopenres.15936.1']
1693,33111026,Pilot Cluster Randomized Controlled Trial of Integrative Nutritional Counseling Versus Standard Diabetes Self-Management Education for Chinese Americans with Type 2 Diabetes.,"Purpose:  Chinese Americans (CAs) with diabetes and limited English proficiency often struggle to adhere to standard diabetes diets focused on food measurement/restriction. Chinese medicine principles commonly inform food choices among CAs but are rarely acknowledged in nutritional interventions. We developed and tested feasibility of a theoretically informed integrative nutritional counseling (INC) program that combines Chinese medicine principles with biomedical nutrition standards.  Methods:  We randomized diabetes self-management education (DSME) classes to include either: (1) usual nutrition curriculum based on American Diabetes Association (ADA) recommendations delivered by a diabetes educator (control) or (2) INC curriculum based on a combination of ADA recommendations and Chinese medicine principles delivered by a diabetes educator and a licensed acupuncturist (intervention). All DSME enrollees were invited to participate in research entailing data collection at three time points: baseline, after the DSME nutrition class, and at 6-month follow-up. Using validated measures, we collected dietary self-efficacy, diabetes distress, diet satisfaction, and dietary adherence. We also measured weight and glycemic control.  Results:  Study participants were 18 Cantonese-speaking patients with diabetes who were predominantly female and older, with low levels of income and acculturation. Intervention and control groups were similar at baseline. INC performed similarly to usual DSME with 100% of participants reporting the INC booklet helped their learning. Dietary adherence significantly improved in participants who received the INC curriculum.  Conclusion:  INC is feasible to implement as part of DSME classes and shows promise as a complementary culturally sensitive addition to usual diabetes nutrition education for CA patients.",2020,Dietary adherence significantly improved in participants who received the INC curriculum.  ,"['Chinese Americans with Type 2 Diabetes', 'Study participants were 18 Cantonese-speaking patients with diabetes who were predominantly female and older, with low levels of income and acculturation', 'participants who received the INC curriculum']","['diabetes self-management education (DSME) classes to include either: (1) usual nutrition curriculum based on American Diabetes Association (ADA) recommendations delivered by a diabetes educator (control) or (2) INC curriculum based on a combination of ADA recommendations and Chinese medicine principles delivered by a diabetes educator and a licensed acupuncturist (intervention', 'integrative nutritional counseling (INC) program', 'Standard Diabetes Self-Management Education', 'Integrative Nutritional Counseling']","['collected dietary self-efficacy, diabetes distress, diet satisfaction, and dietary adherence', 'weight and glycemic control', 'Dietary adherence']","[{'cui': 'C0008121', 'cui_str': 'Chinese Americans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0000943', 'cui_str': 'Acculturation'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1556023', 'cui_str': 'Acupuncturist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0331964,Dietary adherence significantly improved in participants who received the INC curriculum.  ,"[{'ForeName': 'Evelyn Y', 'Initials': 'EY', 'LastName': 'Ho', 'Affiliation': 'Department of Communication Studies, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Pak', 'Affiliation': 'Chinatown Public Health Center, San Francisco, California, USA.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Leung', 'Affiliation': 'Department of Rhetoric and Language, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Shuwen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Choi Kwun', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Jih', 'Affiliation': 'Asian American Research Center on Health, San Francisco, California, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Chao', 'Affiliation': 'Asian American Research Center on Health, San Francisco, California, USA.'}]",Health equity,['10.1089/heq.2020.0002']
1694,33111039,Impact of a Student-Run Free Clinic's Women's Health Program on Perceived Readiness for Clinical Rotations.,"Introduction


Women's health is only briefly explored in the preclerkship medical curriculum. Volunteering in student-run free clinics (SRFCs) increases clinical confidence; such service learning could bridge the gap between limited curricular offerings and student desire for exposure to women's health topics. This study aimed to identify weaknesses in the women's health preclerkship curriculum, build an educational intervention, and explore SRFCs as a teaching tool.
Methods


We performed chart review of SRFC female patients to evaluate care. We held student focus groups to elicit feedback about the established curriculum. Based on this information, we devised a workshop to review practical skills. Participants attended the workshop, volunteered at SRFC, and completed surveys preintervention and at 3 months postintervention. A control group completed baseline and follow-up surveys.
Results


We invited all 151 second-year students to participate; six attended the workshop and 21 served as control. There were no baseline differences between groups regarding age, prior experience with women's health, confidence in relevant skills, and subjective readiness for clinical rotations; the control group had more men. After the workshop, intervention participants reported increased confidence in women's health-related skills and in readiness for the OB/GYN rotation. Gains persisted at 3 months. Three of six students in the workshop group volunteered at SRFC; three of 12 in the control group volunteered.
Conclusions


The addition of an interactive workshop to the existing preclinical curriculum on women's health has lasting impact on subjective readiness for clinical clerkships. SRFC may be a useful addition to classroom learning. This initiative is student-led and reproducible, and could serve as an adjunct to established preclerkship curriculum.",2020,"After the workshop, intervention participants reported increased confidence in women's health-related skills and in readiness for the OB/GYN rotation.","[""Student-Run Free Clinic's Women's Health Program on Perceived Readiness for Clinical Rotations"", 'SRFC female patients to evaluate care']",['SRFC'],"[""confidence in women's health-related skills and in readiness for the OB/GYN rotation""]","[{'cui': 'C4280065', 'cui_str': 'Student-Run Free Clinic'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.0404474,"After the workshop, intervention participants reported increased confidence in women's health-related skills and in readiness for the OB/GYN rotation.","[{'ForeName': 'Arielle W', 'Initials': 'AW', 'LastName': 'Fein', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Paladine', 'Affiliation': 'Columbia University Vagelos School of Physicians and Surgeons, Center for Family and Community Medicine, New York, NY.'}]","PRiMER (Leawood, Kan.)",['10.22454/PRiMER.2020.419532']
1695,33108743,Impact of Two Different Aerobic Periodization Training Protocols on Left Ventricular Function in Patients with Stable Coronary Artery Disease: An Exploratory Study.,"BACKGROUND


We compared the impacts of linear (LP) and non-linear (NLP) aerobic training periodizations on left ventricular (LV) function and geometry in coronary artery disease (CAD) patients.
METHODS


39 CAD patients were randomized to either a 3-month isoenergetic supervised LP or NLP. All underwent standard echocardiography with assessment of 3D LV ejection fraction (LVEF), diastolic function, strain (global longitudinal [GLS], radial and circumferential strain), and strain rate at baseline and study end. Training was performed 3 times/week and included high-intensity interval and moderate-intensity continuous training sessions. Training load was progressively increased in the LP group, while it was deeply increased and intercepted with a recovery week each fourth week in the NLP group.
RESULTS


On the 34 analyzed patients, we found similar improvements for 3D LVEF (Effect Size [ES], LP: 0.29 and NLP: 0.77), radial strain (ES, LP: 0.58; NLP: 0.48, and radial strain rate (ES, LP: 0.87; NLP: 0.17) in both groups (time for all: p≤0.01). All other parameters of cardiac function remained similar.
CONCLUSION


NLP and LP leaded to similar improvements in 3D LVEF and radial strain suggesting a favorable positive cardiac remodeling through myofibers reorganization. These findings must be investigated in patients with more severe cardiac dysfunction. The study was registered on ClinicalTrials.gov (NCT03443193). Novelty: • Linear and non-linear periodization programs improved radial strain, accompanied by improvement of ejection fraction • Both aerobic periodization programs did not negatively impact cardiac function in coronary artery disease patients.",2020,Both aerobic periodization programs did not negatively impact cardiac function in coronary artery disease patients.,"['patients with more severe cardiac dysfunction', '39 CAD patients', 'Patients with Stable Coronary Artery Disease', 'coronary artery disease patients', 'coronary artery disease (CAD) patients']","['isoenergetic supervised LP or NLP', 'Aerobic Periodization Training Protocols', 'NLP', 'linear (LP) and non-linear (NLP) aerobic training periodizations']","['Novelty', '3D LV ejection fraction (LVEF), diastolic function, strain (global longitudinal [GLS], radial and circumferential strain), and strain rate', 'radial strain rate', 'Training load', 'Left Ventricular Function', 'radial strain', '3D LVEF', 'ejection fraction •']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0763527', 'cui_str': 'NGF-like protease'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}]",39.0,0.0467292,Both aerobic periodization programs did not negatively impact cardiac function in coronary artery disease patients.,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Boidin', 'Affiliation': 'University of Montreal, 5622, Montreal, Canada; maxime.boidin@umontreal.ca.'}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'David', 'Affiliation': 'University of Montreal, 5622, Montreal, Canada; louis-philippe.david@umontreal.ca.'}, {'ForeName': 'Lukas Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'University of Montreal, 5622, Montreal, Canada; lukas.trachsel@hin.ch.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Montreal Heart Institute, Cardiovascular Prevention and Rehabilitation Centre, Montreal, Quebec, Canada; mathieu.gayda@icm-mhi.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tremblay', 'Affiliation': 'Universite de Montreal, Montreal, Quebec, Canada; jonathan.tremblay@umontreal.ca.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'University of Montreal, 5622, Montreal, Canada; julie.lalonge@icm-mhi.org.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada; martin.juneau@icm-mhi.org.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada; anil.nigam@icm-mhi.org.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Henri', 'Affiliation': 'Montreal Heart Institute, 25465, Montreal, Quebec, Canada; christine.henri@umontreal.ca.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0423']
1696,33108761,Exercise Interventions for Community-Dwelling Older Adults Following an Emergency Department Consultation for a Minor Injury.,"This study compared effects of exercise-based interventions with usual care on functional decline, physical performance, and health-related quality of life (12-item Short-Form health survey) at 3 and 6 months after minor injuries, in older adults discharged from emergency departments. Participants were randomized either to the intervention or control groups. The interventions consisted of 12-week exercise programs available in their communities. Groups were compared on cumulative incidences of functional decline, physical performances, and 12-item Short-Form health survey scores at all time points. Functional decline incidences were: intervention, 4.8% versus control, 15.4% (p = .11) at 3 months, and 5.3% versus 17.0% (p = .06) at 6 months. While the control group remained stable, the intervention group improved in Five Times Sit-To-Stand Test (3.0 ± 4.5 s, p < .01). The 12-item Short-Form health survey role physical score improvement was twice as high following intervention compared with control. Early exercises improved leg strength and reduced self-perceived limitations following a minor injury.",2020,"Groups were compared on cumulative incidences of functional decline, physical performances, and 12-item Short-Form health survey scores at all time points.","['older adults discharged from emergency departments', 'Community-Dwelling Older Adults Following an Emergency Department Consultation for a Minor Injury']","['Exercise Interventions', 'exercise-based interventions with usual care']","['Five Times Sit-To-Stand Test', 'Functional decline incidences', 'leg strength and reduced self-perceived limitations', '12-item Short-Form health survey role physical score improvement', 'cumulative incidences of functional decline, physical performances, and 12-item Short-Form health survey scores', 'functional decline, physical performance, and health-related quality of life (12-item Short-Form health survey']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332673', 'cui_str': 'Minor injury'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0234885,"Groups were compared on cumulative incidences of functional decline, physical performances, and 12-item Short-Form health survey scores at all time points.","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Fruteau de Laclos', 'Affiliation': ''}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Sirois', 'Affiliation': ''}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Blanchette', 'Affiliation': ''}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Martel', 'Affiliation': ''}, {'ForeName': 'Joannie', 'Initials': 'J', 'LastName': 'Blais', 'Affiliation': ''}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Émond', 'Affiliation': ''}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Daoust', 'Affiliation': ''}, {'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0200']
1697,33108905,No difference in gait pattern between a short collum femoris-preserving and a conventional stem: 44 randomised total hip arthroplasty patients stem evaluated after 2 years.,"BACKGROUND


The uncemented collum femoris-preserving (CFP) stem offers preservation of the femoral neck and a more conservative soft tissue resection, which may facilitate a more normal walking pattern. We used gait analysis to evaluate if patients operated with a CFP stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a conventional uncemented stem.
METHODS


44 patients randomised to receive either a CFP or a Corail stem were studied and were operated using a direct lateral incision. Gait analysis was performed 2 years after the operation with a 12-camera motion capture system and 2 force plates. Hip kinematics and kinetics were analysed and 66 subjects served as controls.
RESULTS


None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups. Neither did the hip kinematics and kinetics. Compared to controls, patients operated with the CFP stem showed an increased stance (62.5% vs. 61.1%,  p <  0.006) and decreased hip abduction (-2.1° vs. -6.5°). Patients operated with the Corail stem showed decreased speed (1.18 vs. 1.23 m/second), and stride length (1.26 vs. 1.33 m), decreased hip extension (-7.5° vs. -12.8°) and range of hip flexion/extension (38° vs. 40.9°), as well as their hip adduction that was increased (6.3° vs. 4°), whereas their hip abduction was reduced (-2.8° vs. -6.5°), ( p <  0.004) compared to the controls.
CONCLUSIONS


Use of a CFP stem did not significantly influence any of the gait parameters studied when compared to a standard stem, but still both stems studied were associated with gait deviations when compared to controls. Whether these differences could be attributed to the stem used, the underlying hip disease, or both is still unknown.",2020,"None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups.","['66 subjects served as controls', '44 patients randomised to receive either a']","['conventional uncemented stem', 'uncemented collum femoris-preserving (CFP) stem', 'CFP or a Corail stem']","['gait pattern', 'stride, cadence and stance', 'Hip kinematics and kinetics', 'stance', 'hip abduction', 'favourable hip kinematics and kinetics', 'hip extension', 'stride length', 'hip kinematics and kinetics', 'gait deviations', 'range of hip flexion/extension']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1096245', 'cui_str': 'Gait deviation'}, {'cui': 'C0576003', 'cui_str': 'Range of hip flexion'}]",,0.0293026,"None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zügner', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Tranberg', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Kärrholm', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Puretic', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Mohaddes', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020967645']
1698,33108910,A combined health action process approach and mHealth intervention to reduce workplace sitting time in office-working adults: a secondary analysis examining health-related quality of life and work performance outcomes.,"OBJECTIVE


This secondary analysis study examined the effects of a 6-week theory-based planning and mHealth text message intervention targeting workplace sitting time on health-related quality of life and work performance in office workers.
DESIGN


Office-working adults ( M   age =45.18 ± 11.33 years) were randomised into either a planning + text message intervention ( n  = 29) or control ( n  = 31) condition.
OUTCOME MEASURES


Workplace sitting time, time spent in specific non-sedentary behaviours (e.g. standing), health-related outcomes (i.e. emotional well-being, energy/fatigue, perceived role limitations), and work performance were assessed at baseline and week 6.
RESULTS


Significant group by time interaction effects, that favoured the intervention group, were found for perceived role limitations due to emotional health problems and emotional well-being. No significant interaction effects emerged for energy/fatigue, role limitations due to physical health problems or work performance. Significant correlations in the expected direction were found between sedentary/non-sedentary behaviours and health-related outcomes. No significant mediation effects were found to suggest the intervention affected health-related outcomes through reductions in sedentary behaviour.
CONCLUSION


Reducing workplace sitting improves emotional well-being and contributes to fewer perceived role limitations due to emotional health problems among office workers.",2020,Reducing workplace sitting improves emotional well-being and contributes to fewer perceived role limitations due to emotional health problems among office workers.,"['office workers', 'office-working adults', 'Office-working adults ( M   age =45.18\u2009±\u200911.33\u2009years']","['6-week theory-based planning and mHealth text message intervention', 'planning\u2009+\u2009text message intervention ( n \u2009=\u200929) or control ( n \u2009=\u200931) condition', 'mHealth intervention']","['Workplace sitting time, time spent in specific non-sedentary behaviours (e.g. standing), health-related outcomes (i.e. emotional well-being, energy/fatigue, perceived role limitations), and work performance', 'workplace sitting time', 'health-related quality of life and work performance', 'sedentary behaviour', 'time interaction effects']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0328877,Reducing workplace sitting improves emotional well-being and contributes to fewer perceived role limitations due to emotional health problems among office workers.,"[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'Exercise and Health Psychology Laboratory, School of Kinesiology, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'Exercise and Health Psychology Laboratory, School of Kinesiology, The University of Western Ontario, London, Ontario, Canada.'}]",Psychology & health,['10.1080/08870446.2020.1838522']
1699,33108932,"Using Cognitive Behavioral Therapy for Insomnia in People with Type 2 Diabetes, Pilot RCT Part I: Sleep and Concomitant Symptom.","OBJECTIVE/BACKGROUND


The primary aim of this study was to examine the effect of Cognitive Behavioral Therapy for Insomnia (CBT-I) on the severity of insomnia in people with Type 2 diabetes (T2D) compared to a health education (HE) control group. The secondary aim was to explore the effect of CBT-I on other sleep outcomes and concomitant symptoms.
PARTICIPANTS


Twenty-eight participants with T2D were randomly assigned to CBT-I ( n  = 14) or HE ( n  = 14).
METHODS


Validated assessments were used at baseline and post intervention to assess sleep outcomes and concomitant symptoms. In addition, actigraph and sleep diaries were used to measure sleep parameters. Independent sample  t  tests and Mann-Whitney  U  tests were utilized to measure between-group differences in the mean change scores.
RESULTS


Participants in the CBT-I group showed higher improvements in the following mean change scores compared to the HE group: insomnia symptoms ( d  = 1.78;  p  < .001), sleep quality ( d  = 1.53;  p  =.001), sleep self-efficacy ( d  = 1.67;  p  < .001). Both actigraph and sleep diary showed improvements in sleep latency and sleep efficiency in the CBT-I group as compared to the HE group. In addition, participants in the CBT-I group showed greater improvement in the mean change scores of depression symptoms ( d  = 1.49;  p  = .002) and anxiety symptoms ( d  = 0.88;  p  = .04) compared to the HE group.
CONCLUSION


This study identified a clinically meaningful effect of CBT-I on sleep outcomes and concomitant symptoms in people with T2D and insomnia symptoms. Further work is needed to investigate the long-term effects of CBT-I in people with T2D and insomnia symptoms.",2020,Both actigraph and sleep diary showed improvements in sleep latency and sleep efficiency in the CBT-I group as compared to the HE group.,"['people with T2D and insomnia symptoms', 'people with Type 2 diabetes (T2D', 'People with Type 2 Diabetes, Pilot RCT', 'Twenty-eight participants with T2D']","['CBT-I', 'HE', 'Cognitive Behavioral Therapy', 'health education (HE) control group']","['mean change scores', 'sleep self-efficacy', 'anxiety symptoms', 'sleep latency and sleep efficiency', 'actigraph and sleep diaries', 'insomnia symptoms', 'mean change scores of depression symptoms', 'sleep outcomes and concomitant symptoms', 'sleep quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",28.0,0.0650865,Both actigraph and sleep diary showed improvements in sleep latency and sleep efficiency in the CBT-I group as compared to the HE group.,"[{'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Alshehri', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center , Kansas City, Kansas.'}, {'ForeName': 'Aqeel M', 'Initials': 'AM', 'LastName': 'Alenazi', 'Affiliation': 'Physical Therapy Department, Prince Sattam Bin Abdulaziz University , Alkharj, Saudi Arabia.'}, {'ForeName': 'Shaima A', 'Initials': 'SA', 'LastName': 'Alothman', 'Affiliation': 'Lifestyle and Health Research Center, Princess Nora Bint Abdulrahman University , Riyadh, Saudi Arabia.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rucker', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center , Kansas City, Kansas.'}, {'ForeName': 'Milind A', 'Initials': 'MA', 'LastName': 'Phadnis', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center , Kansas City, Kansas.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miles', 'Affiliation': 'Endocrinology Department, University of Kansas Medical Center , Kansas City, Kansas.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center , Kansas City, Kansas.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kluding', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center , Kansas City, Kansas.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1831501']
1700,33108981,Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial.,"Maternal sensitivity to infant distress is a key predictor of infant attachment security and social-emotional development. Preventive interventions that support mothers' sensitive responses to infant distress are crucial, as are rigorous evaluations that test  for whom  such interventions are effective. The current randomized controlled trial tested main and moderated effects of an attachment-based intervention on mothers' sensitivity to their infants' distress in 161 low-income, predominantly Latino mother-infant dyads. We tested the brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention in the context of home-based federal Early Head Start services. An intent-to-treat analysis with covariates revealed a positive main intervention effect on maternal sensitivity to distress following a brief novel and potentially fear-inducing procedure ( d  = 0.32). The intervention effect was not moderated by mothers' self-reported attachment security, avoidance, or anxiety. Findings are discussed in terms of the value and feasibility of increasing maternal sensitivity to infant distress through attachment-based intervention.",2020,An intent-to-treat analysis with covariates revealed a positive main intervention effect on maternal sensitivity to distress following a brief novel and potentially fear-inducing procedure ( d  = 0.32).,"[""mothers' sensitivity to their infants' distress in 161 low-income, predominantly Latino mother-infant dyads""]","['attachment-based intervention', 'brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention']","[""mothers' self-reported attachment security, avoidance, or anxiety"", 'maternal sensitivity to distress']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",161.0,0.0539936,An intent-to-treat analysis with covariates revealed a positive main intervention effect on maternal sensitivity to distress following a brief novel and potentially fear-inducing procedure ( d  = 0.32).,"[{'ForeName': 'Allison D', 'Initials': 'AD', 'LastName': 'Hepworth', 'Affiliation': 'University of Maryland School of Social Work , Baltimore, MD, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Berlin', 'Affiliation': 'University of Maryland School of Social Work , Baltimore, MD, USA.'}, {'ForeName': 'Katrieana', 'Initials': 'K', 'LastName': 'Salas', 'Affiliation': 'University of Maryland School of Social Work , Baltimore, MD, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Pardue-Kim', 'Affiliation': 'University of Maryland School of Social Work , Baltimore, MD, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Martoccio', 'Affiliation': 'University of Maryland , College Park, MD, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Jones Harden', 'Affiliation': 'University of Maryland School of Social Work , Baltimore, MD, USA.'}]",Attachment & human development,['10.1080/14616734.2020.1834592']
1701,33108985,Plyometric training increases gross motor coordination and associated components of physical fitness in children.,"There is only limited evidence to suggest that training during childhood produces greater adaptations than at other ages. The aim of this study was to examine the effects of plyometric training (12 weeks, twice/week, 20 min/day) on physical fitness (PF) and gross motor coordination (GMC) in schoolboys aged 7 to 9 years. A total of 116 boys were assigned to two groups: plyometric training group (PT,n=73) and control group (CG,n=43). The CG maintained their normal daily activities. The PT consisted of twice-weekly exercises on nonconsecutive days for twelve weeks under monitored and controlled conditions. PF (handgrip strength, standing long jump (SLJ), curl-ups, sit and reach, square-test, running speed, and 1 mile run test), GMC, Korper-koordinations-test fur Kinder (KTK), and body mass index (BMI) were assessed. The main results through a 2×2 (time×groups) repeated measures analysis variance demonstrated a significant time effect that improves PF and GMC according to the direction of the measure. A group effect was observed only in the abdominal strength test (CG=12.06% and PT=17.04%) and moving sideways (CG=11.1% and PT=12.4%) showing that independent of the group there was an improvement. A significant interaction effect (time×groups) was observed in the flexibility test (CG=-2.7% and PT=3.5%) and STJ (CG=3.1% and PT=18.5%), as well as jumping sideways (CG=16.3% and PT=17.4%) and overall GMC score (CG=9.8% and PT=15.9%), showing that gains in these variables were greater in the PT group. The results suggest that 12 weeks of PT improve components of gross motor coordination and health-related physical fitness in children. Highlights Plyometric exercise-induced adaptations is dependent on neuromotor plasticity of young children. Some physical fitness tests and gross motor coordination can be improved with age and plyometric training during childhood. Plyometric training is not intended to be a stand-alone exercise program and should be incorporated into a well-designed fitness program and gross motor coordination for children.",2020,"A significant interaction effect (time×groups) was observed in the flexibility test (CG=-2.7% and PT=3.5%) and STJ (CG=3.1% and PT=18.5%), as well as jumping sideways (CG=16.3% and PT=17.4%) and overall GMC score (CG=9.8% and PT=15.9%), showing that gains in these variables were greater in the PT group.","['children', 'A total of 116 boys', 'young children', 'schoolboys aged 7 to 9 years']","['Plyometric exercise-induced adaptations', 'Plyometric training', 'plyometric training']","['flexibility test', 'PF (handgrip strength, standing long jump (SLJ), curl-ups, sit and reach, square-test, running speed, and 1 mile run test), GMC, Korper-koordinations-test fur Kinder (KTK), and body mass index (BMI', 'overall GMC score', 'gross motor coordination and health-related physical fitness', 'physical fitness (PF) and gross motor coordination (GMC', 'moving sideways', 'physical fitness', 'PF and GMC', 'abdominal strength test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",116.0,0.0139159,"A significant interaction effect (time×groups) was observed in the flexibility test (CG=-2.7% and PT=3.5%) and STJ (CG=3.1% and PT=18.5%), as well as jumping sideways (CG=16.3% and PT=17.4%) and overall GMC score (CG=9.8% and PT=15.9%), showing that gains in these variables were greater in the PT group.","[{'ForeName': 'Marcelus Brito de', 'Initials': 'MB', 'LastName': 'Almeida', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Carol Góis', 'Initials': 'CG', 'LastName': 'Leandro', 'Affiliation': 'Department of Nutrition, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Daniel da Rocha', 'Initials': 'DDR', 'LastName': 'Queiroz', 'Affiliation': 'Graduate Program in Physical Education, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Marivânio', 'Initials': 'M', 'LastName': 'José-da-Silva', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Thaliane Mayara', 'Initials': 'TM', 'LastName': 'Pessôa Dos Prazeres', 'Affiliation': 'Graduate Program in Physical Education, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Gleybson Maciel', 'Initials': 'GM', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Gabriela Silva', 'Initials': 'GS', 'LastName': 'das-Neves', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Renata Cecília', 'Initials': 'RC', 'LastName': 'Carneiro', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Amanda Dayanne', 'Initials': 'AD', 'LastName': 'Figueredo-Alves', 'Affiliation': 'Department of Physical Education and Sports Science, CAV, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Fábio Yuzo', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Rafael Dos Santos', 'Initials': 'RDS', 'LastName': 'Henrique', 'Affiliation': 'Department of Physical Education, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Marcos André', 'Initials': 'MA', 'LastName': 'Moura-Dos-Santos', 'Affiliation': 'Graduate Program in Physical Education, University of Pernambuco, Recife, Brazil.'}]",European journal of sport science,['10.1080/17461391.2020.1838620']
1702,32047237,ATIR101 administered after T-cell-depleted haploidentical HSCT reduces NRM and improves overall survival in acute leukemia.,"Overcoming graft-versus-host disease (GvHD) without increasing relapse and severe infections is a major challenge after allogeneic hematopoietic stem-cell transplantation (HSCT). ATIR101 is a haploidentical, naïve cell-enriched T-cell product, depleted of recipient-alloreactive T cells to minimize the risk of GvHD and provide graft-versus-infection and -leukemia activity. Safety and efficacy of ATIR101 administered after T-cell-depleted haploidentical HSCT (TCD-haplo + ATIR101) without posttransplant immunosuppressors were evaluated in a Phase 2, multicenter study of 23 patients with acute leukemia and compared with an observational cohort undergoing TCD-haplo alone (n = 35), matched unrelated donor (MUD; n = 64), mismatched unrelated donor (MMUD; n = 37), and umbilical cord blood (UCB; n = 22) HSCT. The primary endpoint, 6-month non-relapse mortality (NRM), was 13% with TCD-haplo + ATIR101. One year post HSCT, TCD-haplo + ATIR101 resulted in lower NRM versus TCD-haplo alone (P = 0.008). GvHD-free, relapse-free survival (GRFS) was higher with TCD-haplo + ATIR101 versus MMUD and UCB (both P < 0.03; 1-year rates: 56.5%, 27.0%, and 22.7%, respectively) and was not statistically different from MUD (1 year: 40.6%). ATIR101 grafts with high third-party reactivity were associated with fewer clinically relevant viral infections. Results suggest that haploidentical, selective donor-cell depletion may eliminate requirements for posttransplant immunosuppressors without increasing GvHD risk, with similar GRFS to MUD. Following these results, a randomized Phase 3 trial versus posttransplant cyclophosphamide had been initiated.",2020,"GvHD-free, relapse-free survival (GRFS) was higher with TCD-haplo + ATIR101 versus MMUD and UCB (both P < 0.03; 1-year rates: 56.5%, 27.0%, and 22.7%, respectively) and was not statistically different from MUD (1 year: 40.6%).","['23 patients with acute leukemia and compared with an observational cohort undergoing TCD-haplo alone (n\u2009=\u200935), matched unrelated donor (MUD; n\u2009=\u200964), mismatched unrelated donor (MMUD; n\u2009=\u200937), and umbilical cord blood (UCB; n\u2009=\u200922) HSCT']","['allogeneic hematopoietic stem-cell transplantation (HSCT', 'ATIR101 administered after T-cell-depleted haploidentical HSCT (TCD-haplo\u2009+\u2009ATIR101', 'posttransplant cyclophosphamide']","['Safety and efficacy', 'GvHD-free, relapse-free survival (GRFS', '6-month non-relapse mortality (NRM', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3179133', 'cui_str': 'Donors, Unrelated'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",23.0,0.067728,"GvHD-free, relapse-free survival (GRFS) was higher with TCD-haplo + ATIR101 versus MMUD and UCB (both P < 0.03; 1-year rates: 56.5%, 27.0%, and 22.7%, respectively) and was not statistically different from MUD (1 year: 40.6%).","[{'ForeName': 'Denis Claude', 'Initials': 'DC', 'LastName': 'Roy', 'Affiliation': 'Blood and Marrow Transplantation Program, Division of Hematology & Oncology, Hôpital Maisonneuve-Rosemont, Université de Montreal, Montreal, QC, Canada. denis-claude.roy@umontreal.ca.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Walker', 'Affiliation': 'Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'KU Leuven, Microbiology Immunology & Transplantation, Clinical Bacteriology and Mycology, and Department of Hematology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lewalle', 'Affiliation': 'Laboratory of Experimental Hematology, Jules Bordet Institut, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Olavarria', 'Affiliation': 'Centre for Haematology, Imperial College London at Hammersmith Hospital, London, UK.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Selleslag', 'Affiliation': 'AZ Sint Jan Brugge-Oostende, Brugge, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lachance', 'Affiliation': 'Blood and Marrow Transplantation Program, Division of Hematology & Oncology, Hôpital Maisonneuve-Rosemont, Université de Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'International Drug Development Institute, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Rovers', 'Affiliation': 'DC Prime, Leiden, Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Santi', 'Affiliation': 'Kiadis Pharma, Amsterdam, Netherlands.'}, {'ForeName': 'Halvard', 'Initials': 'H', 'LastName': 'Bonig', 'Affiliation': 'Institute for Transfusion Medicine and Immunohematology, Goethe University and German Red Cross Blood Service Baden-Württemberg-Hesse, Frankfurt, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': 'Kiadis Pharma, Amsterdam, Netherlands.'}, {'ForeName': 'Jurjen', 'Initials': 'J', 'LastName': 'Velthuis', 'Affiliation': 'Kiadis Pharma, Amsterdam, Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Mielke', 'Affiliation': 'Department of Internal Medicine II, Center of Allogeneic Stem Cell Transplantation, University of Wuerzburg, Wuerzburg University Medical Center, Wuerzburg, Germany.'}]",Leukemia,['10.1038/s41375-020-0733-0']
1703,32321536,Robotic therapy for the hemiplegic shoulder pain: a pilot study.,"BACKGROUNDS


Exoskeletons development arises with a leading role in neurorehabilitation technologies; however, very few prototypes for upper limbs have been tested, contrasted and duly certified in terms of their effectiveness in clinical environments in order to incorporate into the health system. The purpose of this pilot study was to determine if robotic therapy of Hemiplegic Shoulder Pain (HSP) could lead to functional improvement in terms of diminishing of pain, spasticity, subluxation, the increasing of tone and muscle strength, and the satisfaction degree.
METHODS


An experimental study was conducted in 16 patients with painful shoulder post- ischemic stroke in two experimental groups: conventional and robotic therapy. At different stages of its evolution, the robotic therapy effectiveness applied with anti-gravitational movements was evaluated. Clinical trial was developed at the Physical Medicine and Rehabilitation Department of the Surgical Clinical Hospital ""Dr. Juan Bruno Zayas Alfonso"" in Santiago de Cuba, from September 2016 - March 2018. Among other variables: the presence of humeral scapular subluxation (HSS), pain, spasticity, mobility, tone and muscle strength, and the satisfaction degree were recorded. Results with 95% reliability were compared between admission and third months of treatment. The Mann-Whitney U-Test, Chi-Square and Fisher's Exact Tests were used as comparison criteria.
RESULTS


Robotic therapy positively influenced in the decrease and annulment of pain and the spasticity degree, reaching a range increase of joint movement and the improvement of muscle tone.",2020,"RESULTS


Robotic therapy positively influenced in the decrease and annulment of pain and the spasticity degree, reaching a range increase of joint movement and the improvement of muscle tone.","['16 patients with painful shoulder post- ischemic stroke in two experimental groups', 'hemiplegic shoulder pain']","['Robotic therapy', 'conventional and robotic therapy', 'robotic therapy of Hemiplegic Shoulder Pain (HSP']","['pain and the spasticity degree, reaching a range increase of joint movement and the improvement of muscle tone', 'presence of humeral scapular subluxation (HSS), pain, spasticity, mobility, tone and muscle strength, and the satisfaction degree']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332768', 'cui_str': 'Subluxation of joint'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",16.0,0.0282902,"RESULTS


Robotic therapy positively influenced in the decrease and annulment of pain and the spasticity degree, reaching a range increase of joint movement and the improvement of muscle tone.","[{'ForeName': 'Ruthber Rodríguez', 'Initials': 'RR', 'LastName': 'Serrezuela', 'Affiliation': 'University Corporation of Hulia, Nevia, Huila, Colombia. ruthber.rodriguez@corhuila.edu.co.'}, {'ForeName': 'Mauricio Torres', 'Initials': 'MT', 'LastName': 'Quezada', 'Affiliation': 'Universidad de Oriente, Santiago de Cuba, Cuba.'}, {'ForeName': 'Marcia Hernández', 'Initials': 'MH', 'LastName': 'Zayas', 'Affiliation': 'Surgical Clinical Hospital ""Juan Bruno Zayas"", Santiago de Cuba, Cuba.'}, {'ForeName': 'Arquímedes Montoya', 'Initials': 'AM', 'LastName': 'Pedrón', 'Affiliation': 'Surgical Clinical Hospital ""Juan Bruno Zayas"", Santiago de Cuba, Cuba.'}, {'ForeName': 'Daily Milanés', 'Initials': 'DM', 'LastName': 'Hermosilla', 'Affiliation': 'Universidad de Oriente, Santiago de Cuba, Cuba.'}, {'ForeName': 'Roberto Sagaró', 'Initials': 'RS', 'LastName': 'Zamora', 'Affiliation': 'Universidad de Oriente, Santiago de Cuba, Cuba.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00674-6']
1704,33111142,The ACCOST-HH Trial.,,2020,,[],[],[],[],[],[],,0.029329,,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': 'Department of Cardiology, Charite University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Berlin.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'Department of Internal Medicine II - Cardiology, University of Ulm, Medical Center, Ulm, Germany.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Kessler', 'Affiliation': 'Department of Internal Medicine II - Cardiology, University of Ulm, Medical Center, Ulm, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine, University Medical Centre Mannheim, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center, Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Burdelski', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center, Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Blankenberg', 'Affiliation': 'Department of Cardiology, Charite University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Berlin.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department of Cardiology, Charite University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Berlin.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Department of Cardiology, Charite University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Berlin.'}, {'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Karakas', 'Affiliation': 'Department of Cardiology, Charite University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Berlin.'}]",European heart journal,['10.1093/eurheartj/ehaa757']
1705,33101068,Study Protocol: The Coaching Alternative Parenting Strategies (CAPS) Study of Parent-Child Interaction Therapy in Child Welfare Families.,"Background


Child maltreatment (CM) constitutes a serious public health problem in the United States with parents implicated in a majority of physical abuse and neglect cases. Parent-Child Interaction Therapy (PCIT) is an intensive intervention for CM families that uses innovative ""bug-in-ear"" coaching to improve parenting and child outcomes, and reduce CM recidivism; however, the mechanisms underlying its effects are little understood. The Coaching Alternative Parenting Strategies (CAPS) study aims to clarify the behavioral, neural, and physiological mechanisms of action in PCIT that support positive changes in parenting, improve parent and child self-regulation and social perceptions, and reduce CM in child welfare-involved families.
Methods


The CAPS study includes 204 child welfare-involved parent-child dyads recruited from Oregon Department of Human Services to participate in a randomized controlled trial of PCIT versus a services-as-usual control condition (clinicaltrials.gov, NCT02684903). Children ages 3-8 years at study entry and their parents complete a pre-treatment assessment prior to randomization and a post-treatment assessment 9-12 months post study entry. Dyads randomized to PCIT complete an additional, abbreviated assessment at mid-treatment. Each assessment includes individual and joint measures of parents' and children's cardiac physiology at rest, during experimental tasks, and in recovery; observational coding of parent-child interactions; and individual electroencephalogram (EEG) sessions including attentional and cognitive control tasks. In addition, parents and children complete an emotion regulation task and parents report on their own and their child's adverse childhood experiences and socio-cognitive processes, while children complete a cognitive screen and a behavioral measure of inhibitory control. Parents and children also provide anthropometric measures of allostatic load and 4-5 whole blood spots to assess inflammation and immune markers. CM recidivism is assessed for all study families at 6-month follow-up. Post-treatment and follow-up assessments are currently underway.
Discussion


Knowledge gained from this study will clarify PCIT effects on neurobehavioral target mechanisms of change in predicting CM risk reduction, positive, responsive parenting, and children's outcomes. This knowledge can help to guide efforts to tailor and adapt PCIT to vary in dosage and cost on the basis of individual differences in CM-risk factors.",2020,"Parent-Child Interaction Therapy (PCIT) is an intensive intervention for CM families that uses innovative ""bug-in-ear"" coaching to improve parenting and child outcomes, and reduce CM recidivism; however, the mechanisms underlying its effects are little understood.","['Children ages 3-8 years at study entry and their parents complete a pre-treatment assessment prior to randomization and a post-treatment\xa0assessment 9-12 months post study entry', 'Child Welfare Families', '204 child welfare-involved parent-child dyads recruited from Oregon Department of Human Services to participate in a randomized controlled trial of']","['individual electroencephalogram (EEG) sessions including attentional and cognitive control tasks', 'Coaching Alternative Parenting Strategies (CAPS) Study of Parent-Child Interaction Therapy', '\n\n\nChild maltreatment (CM', 'PCIT', 'Parent-Child Interaction Therapy (PCIT']","['CM recidivism', 'emotion regulation task']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}]","[{'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.024037,"Parent-Child Interaction Therapy (PCIT) is an intensive intervention for CM families that uses innovative ""bug-in-ear"" coaching to improve parenting and child outcomes, and reduce CM recidivism; however, the mechanisms underlying its effects are little understood.","[{'ForeName': 'Akhila K', 'Initials': 'AK', 'LastName': 'Nekkanti', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Jeffries', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Scholtes', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shimomaeda', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'DeBow', 'Affiliation': 'Center for Excellence, Graduate School of Medicine, University of Tennessee, Knoxville, TN, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Norman Wells', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lyons', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Giuliano', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Felicia J', 'Initials': 'FJ', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Kyndl X', 'Initials': 'KX', 'LastName': 'Woodlee', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Beverly W', 'Initials': 'BW', 'LastName': 'Funderburk', 'Affiliation': 'Department of Developmental & Behavioral Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Skowron', 'Affiliation': 'Center for Translational Neuroscience, University of Oregon, Eugene, OR, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00839']
1706,33101079,"Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial.","The microbiota-gut-brain axis has been recently recognized as a key modulator of neuropsychiatric health. In this framework, probiotics (recently named ""psychobiotics"") may modulate brain activity and function, possibly improving the behavioral profiles of children with Autism Spectrum Disorder (ASD). We evaluated the effects of probiotics on autism in a double-blind randomized, placebo-controlled trial of 85 preschoolers with ASD (mean age, 4.2 years; 84% boys). Participants were randomly assigned to probiotics (De Simone Formulation) (n=42) or placebo (n=43) for six months. Sixty-three (74%) children completed the trial. No differences between groups were detected on the primary outcome measure, the Total Autism Diagnostic Observation Schedule - Calibrated Severity Score (ADOS-CSS). An exploratory secondary analysis on subgroups of children with or without Gastrointestinal Symptoms (GI group, n= 30; NGI group, n=55) revealed in the NGI group treated with probiotics a significant decline in ADOS scores as compared to that in the placebo group, with a mean reduction of 0.81 in Total ADOS CSS and of 1.14 in Social-Affect ADOS CSS over six months. In the GI group treated with probiotics we found greater improvements in some GI symptoms, adaptive functioning, and sensory profiles than in the GI group treated with placebo. These results suggest potentially positive effects of probiotics on core autism symptoms in a subset of ASD children independent of the specific intermediation of the probiotic effect on GI symptoms. Further studies are warranted to replicate and extend these promising findings on a wider population with subsets of ASD patients which share targets of intervention on the microbiota-gut-brain axis.
Clinical Trial Registration


ClinicalTrials.gov, identifier NCT02708901.",2020,"In the GI group treated with probiotics we found greater improvements in some GI symptoms, adaptive functioning, and sensory profiles than in the GI group treated with placebo.","['subgroups of children with or without Gastrointestinal Symptoms (GI group, n= 30; NGI group, n=55', 'Sixty-three (74%) children completed the trial', 'Autism Spectrum Disorders', '85 preschoolers with ASD (mean age, 4.2 years; 84% boys', 'children with Autism Spectrum Disorder (ASD']","['probiotics (De Simone Formulation', 'placebo', 'Probiotic Supplementation', 'probiotics']","['ADOS scores', 'Gastrointestinal, Sensory and Core Symptoms', 'some GI symptoms, adaptive functioning, and sensory profiles', 'Total Autism Diagnostic Observation Schedule - Calibrated Severity Score (ADOS-CSS']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C2732625', 'cui_str': 'Sensory profile'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}]",85.0,0.253466,"In the GI group treated with probiotics we found greater improvements in some GI symptoms, adaptive functioning, and sensory profiles than in the GI group treated with placebo.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Santocchi', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Prosperi', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Calderoni', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Gaggini', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Apicella', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Tancredi', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Billeci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mastromarino', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Grossi', 'Affiliation': 'Department of Autism Research, Villa Santa Maria Institute, Tavernerio, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Maria Aurora', 'Initials': 'MA', 'LastName': 'Morales', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Muratori', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.550593']
1707,33101091,Implementation of Guidelines on Prevention of Coercion and Violence (PreVCo) in Psychiatry: Study Protocol of a Randomized Controlled Trial (RCT).,"Background


Coercive measures are among the most controversial interventions in psychiatry. There is a large discrepancy between the sheer number of high-quality guidelines and the small number of scientifically accompanied initiatives to promote and evaluate their implementation into clinical routine. In Germany, an expert group developed guidelines to provide evidence- and consensus-based recommendations on how to deal with violence and coercion in psychiatry.
Methods


The study presented examines whether coercive measures on psychiatric wards can be reduced by means of an operationalized implementation of the guidelines ""Prevention of coercion: prevention and therapy of aggressive behavior in adults"". Out of a set of 12 interventions offered, wards are free to choose three interventions they want to implement. The primary outcome is the number of coercive measures per bed and month/year. Secondary outcomes are cumulative duration of coercive measures per bed and month/year. The most important control variable is the number of aggressive incidents. We plan to recruit 52 wards in Germany. Wards treating both voluntary and compulsorily admitted patients will be included. A 1:1 stratified randomized controlled trial will be conducted stratified by the amount of coercive measures and implemented aspects of the guidelines. In addition to the control group analysis, a waiting list design allows a pre-post analysis for all participating wards of the waiting list group. A parallel qualitative study will examine factors related to successful implementation and to successful reduction of coercion as well as relevant barriers.
Discussion


We are planning a nationwide study on the implementation of evidence- and consensus-based guidelines in psychiatric hospitals. This study intends to promote the transfer of expert knowledge as well as results from clinical trials into clinical routine with the potential to change supply structures in mental health sector.
Clinical Trial Registration


www.isrctn.com, identifier ISRCTN71467851.",2020,"The study presented examines whether coercive measures on psychiatric wards can be reduced by means of an operationalized implementation of the guidelines ""Prevention of coercion: prevention and therapy of aggressive behavior in adults"".","['adults', 'psychiatric hospitals', '52 wards in Germany']",[],"['number of coercive measures per bed and month/year', 'cumulative duration of coercive measures per bed and month/year']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0920934,"The study presented examines whether coercive measures on psychiatric wards can be reduced by means of an operationalized implementation of the guidelines ""Prevention of coercion: prevention and therapy of aggressive behavior in adults"".","[{'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Steinert', 'Affiliation': 'Center for Psychiatry Suedwuerttemberg, Ulm University, Ravensburg-Weissenau, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Vivantes Hospital Am Urban and Vivantes Hospital am Friedrichshain, Berlin, Germany.'}, {'ForeName': 'Lieselotte', 'Initials': 'L', 'LastName': 'Mahler', 'Affiliation': 'Department of Psychiatry and Psychotherapy (CCM), Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Muche', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Baumgardt', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Vivantes Hospital Am Urban and Vivantes Hospital am Friedrichshain, Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bühling-Schindowski', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Vivantes Hospital Am Urban and Vivantes Hospital am Friedrichshain, Berlin, Germany.'}, {'ForeName': 'Celline', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'Department of Psychiatry and Psychotherapy (CCM), Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kampmann', 'Affiliation': 'Center for Psychiatry Suedwuerttemberg, Ulm University, Ravensburg-Weissenau, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Sauter', 'Affiliation': 'Center for Psychiatry Suedwuerttemberg, Ulm University, Ravensburg-Weissenau, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Vandamme', 'Affiliation': 'Department of Psychiatry and Psychotherapy (CCM), Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weinmann', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Vivantes Hospital Am Urban and Vivantes Hospital am Friedrichshain, Berlin, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hirsch', 'Affiliation': 'Center for Psychiatry Suedwuerttemberg, Ulm University, Ravensburg-Weissenau, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.579176']
1708,33101132,Acute Aerobic Exercise Ameliorates Cravings and Inhibitory Control in Heroin Addicts: Evidence From Event-Related Potentials and Frequency Bands.,"Objective


Aerobic exercise is considered a potential adjunctive treatment for heroin addicts, but little is known about its mechanisms. Less severe cravings and greater inhibitory control have been associated with reduced substance use. The aim of the current study was to determine the effects, as measured by behavioral and neuroelectric measurements, of acute aerobic exercise on heroin cravings and inhibitory control induced by heroin-related conditions among heroin addicts.
Design


The present study used a randomized controlled design.
Methods


Sixty male heroin addicts who met the DSM-V criteria were recruited from the Isolated Detoxification Center in China and randomly assigned to one of two groups; one group completed a 20-min bout of acute stationary cycle exercise with vigorous intensity (70-80% of maximum heart rate, exercise group), and the other group rested (control group). The self-reported heroin craving levels and inhibitory control outcomes (measured by a heroin-related Go/No-Go task) were assessed pre- and post-exercise.
Results


The heroin craving levels in the exercise group were significantly attenuated during, immediately following, and 40 min after vigorous exercise compared with before exercise; moreover, during exercise, a smaller craving was observed in the exercise group than in the control group. Acute exercise also facilitated inhibition performance in the No-Go task. After exercise, the participants' accuracy, the N2d amplitudes, and the theta two band spectral power during the No-Go conditions were higher in the exercise group than in the control group. Interestingly, significant correlations between the changes in these sensitive measurements and the changes in cravings were observed.
Conclusions


This is the first empirical study to demonstrate that aerobic exercise may be efficacious for reducing heroin cravings and promoting inhibitory control among heroin addicts.",2020,"The heroin craving levels in the exercise group were significantly attenuated during, immediately following, and 40 min after vigorous exercise compared with before exercise; moreover, during exercise, a smaller craving was observed in the exercise group than in the control group.","['Methods\n\n\nSixty male heroin addicts who met the DSM-V criteria were recruited from the Isolated Detoxification Center in China', 'heroin addicts', 'Heroin Addicts']","['20-min bout of acute stationary cycle exercise with vigorous intensity (70-80% of maximum heart rate, exercise group), and the other group rested (control group', 'acute aerobic exercise', 'Acute Aerobic Exercise', 'aerobic exercise', 'Aerobic exercise']","['heroin craving levels', 'severe cravings', 'changes in cravings', 'smaller craving', 'heroin cravings']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0858353', 'cui_str': 'Addicted to heroin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",60.0,0.0624571,"The heroin craving levels in the exercise group were significantly attenuated during, immediately following, and 40 min after vigorous exercise compared with before exercise; moreover, during exercise, a smaller craving was observed in the exercise group than in the control group.","[{'ForeName': 'Dongshi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Faculty of Sports Science, Ningbo University, Ningbo, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Center for Mental Health and Education, Ningbo City College of Vocational Technology, Ningbo, China.'}, {'ForeName': 'Jiachen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Faculty of Sports Science, Ningbo University, Ningbo, China.'}, {'ForeName': 'Yingzhi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.561590']
1709,33101141,Construction of Cognitive Maps to Improve Reading Performance by Text Signaling: Reading Text on Paper Compared to on Screen.,"Reading text from a screen has been shown to be less effective compared with reading text from paper. Various signals may provide both background information and navigational cues, and may promote the construction of cognitive maps during on-screen reading, thus improving reading performance. This study randomly divided 75 college students into a paper reading group and an on-screen reading group. Both groups were tested for navigation and reading comprehension in response to three different forms of signaling (plain text, physical signaling, and verbal signaling). The results showed that when plain text was presented, the navigation and comprehension scores of the paper reading group were significantly higher than those of the on-screen reading group. However, no significant difference was found between both groups under signaling conditions. The navigation and comprehension scores of both groups were significantly higher under signaling conditions than under plain text. Moreover, the comprehension score of the on-screen reading group under physical signaling was significantly higher than that under verbal signaling. This research suggested that signals help to construct cognitive maps and effectively improve reading performance. Besides, physical signaling, such as underlining and bold formatting, is more effective for on-screen reading. The present study provides a practical and effective approach for improving on-screen reading based on cognitive map theory.",2020,"The results showed that when plain text was presented, the navigation and comprehension scores of the paper reading group were significantly higher than those of the on-screen reading group.",['75 college students into a paper reading group and an on-screen reading group'],[],"['reading performance', 'navigation and comprehension scores', 'comprehension score of the on-screen reading group under physical signaling']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",[],"[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",75.0,0.0128404,"The results showed that when plain text was presented, the navigation and comprehension scores of the paper reading group were significantly higher than those of the on-screen reading group.","[{'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Psychology, School of Educational Science, Hunan Normal University, Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Tang', 'Affiliation': 'Department of Psychology, School of Educational Science, Hunan Normal University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Psychology, School of Educational Science, Hunan Normal University, Changsha, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.571957']
1710,33101161,Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease.,"Background:  Balance deficits in people with Parkinson's disease (PD) are often not helped by pharmacological or surgical treatment. Although balance exercise intervention has been shown to improve clinical measures of balance, the efficacy of exercise on different, objective balance domains is still unknown.  Objective:  To compare the sensitivity to change in objective and clinical measures of several different domains of balance and gait following an Agility Boot Camp with Cognitive Challenges (ABC-C) intervention.  Methods:  In this cross-over, randomized design, 86 individuals with PD participated in 6-week (3×/week) ABC-C exercise classes and 6-week education classes, consisting of 3-6 individuals. Blinded examiners tested people in their practical off state. Objective outcome measures from wearable sensors quantified four domains of balance: sway in standing balance, anticipatory postural adjustments (APAs) during step initiation, postural responses to the push-and-release test, and a 2-min natural speed walk with and without a cognitive task. Clinical outcome measures included the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, the Mini Balance Evaluation Systems Test (Mini-BESTest), the Activities of Balance Confidence (ABC), and the Parkinson's Disease Questionnaire (PDQ-39). The standardized response means (SRM) of the differences between before and after each intervention compared responsiveness of outcomes to intervention. A linear mixed model compared effects of exercise with the active control-education intervention.  Results:  The most responsive outcome measures to exercise intervention with an SRM > 0.5 were objective measures of gait and APAs, specifically arm range of motion, gait speed during a dual-task walk, trunk coronal range of motion, foot strike angle, and first-step length at step initiation. The most responsive clinical outcome measure was the patient-reported PDQ-39 activities daily living subscore, but all clinical measures had SRMs <0.5.  Conclusions:  The objective measures were more sensitive to change after exercise intervention compared to the clinical measures. Spatiotemporal parameters of gait, including gait speed with a dual task, and APAs were the most sensitive objective measures, and perceived functional independence was the most sensitive clinical measure to change after the ABC-C exercise intervention. Future exercise intervention to improve gait and balance in PD should include objective outcome measures.",2020,"Spatiotemporal parameters of gait, including gait speed with a dual task, and APAs were the most sensitive objective measures, and perceived functional independence was the most sensitive clinical measure to change after the ABC-C exercise intervention.","[""people with Parkinson's disease (PD"", ""Parkinson's Disease"", '86 individuals with PD participated in 6-week (3×/week) ABC-C exercise classes and 6-week education classes, consisting of 3-6 individuals']","['balance exercise intervention', 'Agility Boot Camp with Cognitive Challenges (ABC-C) intervention', 'Exercise Intervention', 'Future exercise intervention']","['objective measures of gait and APAs, specifically arm range of motion, gait speed during a dual-task walk, trunk coronal range of motion, foot strike angle, and first-step length at step initiation', ""Activities of Balance Confidence (ABC), and the Parkinson's Disease Questionnaire (PDQ-39"", 'Spatiotemporal parameters of gait, including gait speed with a dual task, and APAs', 'standing balance, anticipatory postural adjustments (APAs) during step initiation, postural responses to the push-and-release test, and a 2-min natural speed walk with and without a cognitive task', ""Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'PDQ-39 activities daily living subscore']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0454306', 'cui_str': 'Exercise class'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442759', 'cui_str': '3/6'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1285611', 'cui_str': 'Measure of gait'}, {'cui': 'C0113523', 'cui_str': ""diadenosine 5',5''''-P1,P6-hexaphosphate""}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",86.0,0.0367257,"Spatiotemporal parameters of gait, including gait speed with a dual task, and APAs were the most sensitive objective measures, and perceived functional independence was the most sensitive clinical measure to change after the ABC-C exercise intervention.","[{'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Vrutangkumar V', 'Initials': 'VV', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harker', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carlson-Kuhta', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Se Hee', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Barlow', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00940']
1711,33101174,Short-Term Effects of Single-Session Split-Belt Treadmill Training on Dual-Task Performance in Parkinson's Disease and Healthy Elderly.,"Background:  Dual-tasking is challenging for people with Parkinson's disease and freezing of gait (PD+FOG) and can exacerbate freezing episodes and falls. Split-belt treadmill training (SBT) is a novel tool to train complex gait and may improve dual-task (DT) walking and turning.  Objective:  To investigate the single-session effects of SBT on DT walking and DT turning performance in PD+FOG and older adults (OA), compared to regular treadmill training.  Methods:  Forty-five PD+FOG and 36 OA participated in a single training session (30 min). They were randomized into one of four training groups: (A) SB75-steady belt speed ratio 0.75:1; (B) SB50-steady belt speed ratio 0.5:1; (C) SBCR-changing belt speed ratios between 0.75:1 and 0.5:1; and (D) Tied-Belt (TBT). Over-ground straight-line gait and an alternating turning in place task combined with a cognitive dual-task (DT) (auditory Stroop) were assessed pre- and post-training, and the following day (retention). Constrained longitudinal data analysis was used to investigate the training effects for all participants and for PD+FOG alone.  Results:  DT gait speed improved at post-training for all groups ( p  < 0.001). However, SBT (SB50 and SBCR) led to larger post-training improvements compared to TBT, which were still visible at retention (SB50). For mean DT turning speed and Stroop response time while walking, only SBT groups showed significant improvements at post-training or retention. DT stride length, peak DT turning speed, and Stroop performance index while walking also showed larger gains in SBT compared to TBT. Results for PD+FOG alone showed similar effects although with smaller effect sizes.  Conclusions:  A single session of SBT in PD+FOG and OA showed larger short-term effects on DT walking and turning compared to TBT. Cognitive DT performance was also improved in SBT, likely due to reduced cortical control of gait. These results illustrate the potential for SBT to improve DT during complex gait and possibly reduce fall risk in clinical and healthy populations.",2020,"DT stride length, peak DT turning speed, and Stroop performance index while walking also showed larger gains in SBT compared to TBT.","[""Parkinson's Disease and Healthy Elderly"", 'PD+FOG and older adults (OA', ""people with Parkinson's disease and freezing of gait (PD+FOG"", 'Methods:  Forty-five PD+FOG and 36 OA participated in a']","['Single-Session Split-Belt Treadmill Training', 'single training session', 'PD+FOG', 'regular treadmill training', 'Split-belt treadmill training (SBT', 'ground straight-line gait and an alternating turning in place task combined with a cognitive dual-task (DT) (auditory Stroop', 'SBT']","['mean DT turning speed and Stroop response time', 'Cognitive DT performance', 'Dual-Task Performance', 'DT walking and DT turning performance', 'DT gait speed', 'dual-task (DT) walking and turning', 'SBT (SB50 and SBCR', 'DT stride length, peak DT turning speed, and Stroop performance index']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036782', 'cui_str': 'Serum bactericidal titer test'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0036782', 'cui_str': 'Serum bactericidal titer test'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0174544,"DT stride length, peak DT turning speed, and Stroop performance index while walking also showed larger gains in SBT compared to TBT.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': ""D'Cruz"", 'Affiliation': 'Neurorehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Seuthe', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-University (CAU) Kiel, Kiel, Germany.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Ginis', 'Affiliation': 'Neurorehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hulzinga', 'Affiliation': 'Neurorehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlenstedt', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-University (CAU) Kiel, Kiel, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Neurorehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}]",Frontiers in neurology,['10.3389/fneur.2020.560084']
1712,33101504,Long-term Effects of Unilateral and Bilateral Otitis Media and Myringotomy on Long-Latency Verbal and Non-Verbal Auditory-Evoked Potentials.,"Introduction   Otitis media (OM) is considered one of the most common reasons patients seek medical care in childhood. The fluctuating nature of hearing loss in cases of OM leads to irregular sound stimulation of the central auditory nervous system.  Objectives   To analyze the long-latency auditory-evoked potential (LLAEP) by verbal and nonverbal sounds in children with a history of OM in the first six years of life.  Methods   A total of 106 schoolchildren participated in the study, 55 females and 51 males, aged between 8 and 16 years, who were divided into 3 groups: the control group (CG), the bilateral experimental group (BEG), and the unilateral experimental group (UEG). All children underwent a complete audiological evaluation (audiometry, logoaudiometry and immitance testing) and an electrophysiological evaluation (LLAEP with toneburst stimulus - LLAEP-TB, and LLAEP with speech stimulus - LLAEP-S).  Results   Both study groups (BEG and UEG) presented a statistically lower performance (  p   < 0.005) when compared with the CG regarding all of the electrophysiological tests with the prolongation of the latency values and decrease in the amplitude values: LLAEP-TB (BEG: latency - N1, P2, N2 [females] and P300, amplitude - N1 and P2), LLAEP-S (BEG: latency - P2 and N2 [females], amplitude - P2 /UEG: latency - P2 and P300, amplitude: N1 and P2).  Conclusion   Children who had suffered secretory OM in the first six years of life and who had undergone myringotomy for the placement of a ventilation tube, either unilaterally or bilaterally, presented worse performance in their electrophysiological responses to verbal and nonverbal LLAEPs.",2020,"Both study groups (BEG and UEG) presented a statistically lower performance (  p   < 0.005) when compared with the CG regarding all of the electrophysiological tests with the prolongation of the latency values and decrease in the amplitude values: LLAEP-TB (BEG: latency - N1, P2, N2 [females] and P300, amplitude - N1 and P2), LLAEP-S (BEG: latency - P2 and N2 [females], amplitude - P2 /UEG: latency - P2 and P300, amplitude: N1 and P2).  ","['106 schoolchildren participated in the study, 55 females and 51 males, aged between 8 and 16 years', 'children with a history of OM in the first six years of life', 'Children who had suffered secretory OM in the first six years of life and who had']","['undergone myringotomy', 'complete audiological evaluation (audiometry, logoaudiometry and immitance testing) and an electrophysiological evaluation (LLAEP with toneburst stimulus - LLAEP-TB, and LLAEP with speech stimulus - LLAEP-S', 'Unilateral and Bilateral Otitis Media and Myringotomy', 'Introduction  \u2003Otitis media (OM', 'long-latency auditory-evoked potential (LLAEP) by verbal and nonverbal sounds', 'control group (CG), the bilateral experimental group (BEG), and the unilateral experimental group (UEG']","['Long-Latency Verbal and Non-Verbal Auditory-Evoked Potentials', 'amplitude values: LLAEP-TB (BEG: latency - N1, P2, N2 [females] and P300, amplitude - N1 and P2), LLAEP-S (BEG: latency - P2 and N2 [females], amplitude - P2 /UEG: latency - P2 and P300, amplitude: N1 and P2']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200297', 'cui_str': 'Audiological evaluation'}, {'cui': 'C0004286', 'cui_str': 'Audiometric test'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0856467', 'cui_str': 'Bilateral otitis media'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015215', 'cui_str': 'Auditory evoked potential'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015215', 'cui_str': 'Auditory evoked potential'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}]",106.0,0.0201793,"Both study groups (BEG and UEG) presented a statistically lower performance (  p   < 0.005) when compared with the CG regarding all of the electrophysiological tests with the prolongation of the latency values and decrease in the amplitude values: LLAEP-TB (BEG: latency - N1, P2, N2 [females] and P300, amplitude - N1 and P2), LLAEP-S (BEG: latency - P2 and N2 [females], amplitude - P2 /UEG: latency - P2 and P300, amplitude: N1 and P2).  ","[{'ForeName': 'Milaine Dominici', 'Initials': 'MD', 'LastName': 'Sanfins', 'Affiliation': 'Human Development Department, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Donadon', 'Affiliation': 'Human Development Department, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.'}, {'ForeName': 'Letícia Reis', 'Initials': 'LR', 'LastName': 'Borges', 'Affiliation': 'Human Development Department, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.'}, {'ForeName': 'Piotr H', 'Initials': 'PH', 'LastName': 'Skarzynski', 'Affiliation': 'Department of Teleaudiology and Hearing Screening, World Hearing Center, Institute of Physiology and Pathology of Hearing, Warsaw/Kajetany, Poland.'}, {'ForeName': 'Maria Francisca', 'Initials': 'MF', 'LastName': 'Colella-Santos', 'Affiliation': 'Human Development Department, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.'}]",International archives of otorhinolaryngology,['10.1055/s-0039-1697006']
1713,33101559,Comparative Analysis of the Influence of Selected Physical Factors on the Level of Pain in the Course of Temporomandibular Joint Disorders.,"Introduction


Temporomandibular joints (TMJs) play a very significant function in the activity of the locomotor system of the masticatory system. But they are often a source of pain, myopathy, myoarthropathy, and malfunction of their surrounding or internal structures. The treatment of a patient's discomfort associated with masticatory system dysfunctions strongly depends on their cause.  Aim of the Study . The objective of the study was to evaluate the impact of selected physical factors: LED light therapy with electromagnetic field and cryotherapy for the level of pain, in the treatment of patients suffering from temporomandibular disorders (TMDs).
Materials and Methods


The study included 60 patients of both genders with diagnosed TMD in a clinical trial. The participants were randomly divided into two groups. Each group consisted of 30 people and was subjected to separate therapies in which LED light therapy with electromagnetic field (MLT) and cryotherapy (CT) were applied.
Results


Having assessed the results of the author's own research in terms of analgesic activity, determined on the VAS scale during the daily routine activity of the mandible and its individual movements, in general, each of the studied groups demonstrated a considerable decrease in the level of the patients' perception of pain (<0.001). Having compared both the therapeutic methods used, a greater reduction in the level of perceived pain was achieved with MLT ( p =0.002). The type of therapy used turned out to be the only significant factor for the magnitude of this reduction.
Conclusions


Conclusions based on the results of our own research indicate that the selected methods of treatment demonstrate an analgesic effect in terms of the overall discomfort in the course of TMD, and that they may be an alternative pain relief thereby reducing the patient's intake of painkillers.",2020,"Having compared both the therapeutic methods used, a greater reduction in the level of perceived pain was achieved with MLT ( p =0.002).","['patients suffering from temporomandibular disorders (TMDs', '60 patients of both genders with diagnosed TMD in a clinical trial', 'Temporomandibular Joint Disorders']","['LED light therapy with electromagnetic field (MLT) and cryotherapy (CT', 'electromagnetic field and cryotherapy']","['Level of Pain', 'VAS scale', 'level of perceived pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0274965,"Having compared both the therapeutic methods used, a greater reduction in the level of perceived pain was achieved with MLT ( p =0.002).","[{'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Kopacz', 'Affiliation': 'Department of Propaedeutic, Physical Diagnostics and Dental Physiotherapy, Faculty of Medicine and Dentistry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Żaneta', 'Initials': 'Ż', 'LastName': 'Ciosek', 'Affiliation': 'Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gronwald', 'Affiliation': 'Department of Propaedeutic, Physical Diagnostics and Dental Physiotherapy, Faculty of Medicine and Dentistry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Skomro', 'Affiliation': 'Department of Propaedeutic, Physical Diagnostics and Dental Physiotherapy, Faculty of Medicine and Dentistry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ardan', 'Affiliation': 'Department of Econometrics, Faculty of Economic Sciences, Koszalin University of Technology, Koszalin, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Lietz-Kijak', 'Affiliation': 'Department of Propaedeutic, Physical Diagnostics and Dental Physiotherapy, Faculty of Medicine and Dentistry, Pomeranian Medical University, Szczecin, Poland.'}]",Pain research & management,['10.1155/2020/1036306']
1714,33101574,Electroacupuncture Versus Analgesics for Patients with Stage IIIB Cervical Cancer Post Cisplatin Chemotherapy.,"Background:  The prevalence of pain at advanced cervical cancer stages is increasing. Existing World Health Organization recommendations for management comprises a 3-step ladder of analgesic therapy but this still cannot address this pain optimally. An alternative therapy used to reduce pain, acupuncture, is almost without side-effects, is safe, and is easy to implement. This study compared electroacupuncture (EA) versus paracetamol 500 mg +10-mg codeine therapy for patients with stage-IIIB cervical cancer post cisplatin chemotherapy.  Materials and Methods:  Participants were divided into 2 groups (treatment and control groups). A quasiexperimental study was conducted using a nonequivalent control group pretest-post-test design. Participants in the treatment group were given EA for 30 minutes 10 times over 3 weeks, while participants in the control group were given paracetamol 3 × 500 mg and codeine 3 × 10 mg orally every day for 3 weeks. Statistical analysis used paired  t -tests, a Wilcoxon test, an independent  t -test, or a Mann-Whitney- U  test with  P  < 0.05.  Results:  Pretest and post-test pain-scale levels were 5.39 ± 0.62 and 4.57 ± 0.88, respectively ( P  < 0.001). Average endorphin-β levels at pretest and post-test were 571.80 ± 281.13 and 491.14 ± 272.14, respectively ( P  = 0.818). Median values of quality of life at pretest and post-test were 681.75 (range: 503.80-915.20) and 635.25 (range: 538.20-781.20;  P  = 0.383), respectively.  Conclusions:  Pain-control therapy using drugs or EA produces similar results. However, EA, subjectively, produces improved pain-scale results better than pharmaceuticals.",2020,"Average endorphin-β levels at pretest and post-test were 571.80 ± 281.13 and 491.14 ± 272.14, respectively ( P  = 0.818).","['Patients with Stage IIIB Cervical Cancer Post Cisplatin Chemotherapy', 'patients with stage-IIIB cervical cancer post cisplatin chemotherapy']","['Pain-control therapy using drugs or EA', 'EA', 'Electroacupuncture Versus Analgesics', 'paracetamol 3\u2009×\u2009500\u2009mg and codeine 3', 'electroacupuncture (EA) versus paracetamol 500\u2009mg +10-mg codeine therapy']","['Average endorphin-β levels', 'pain-scale', 'Median values of quality of life', 'Results:  Pretest and post-test pain-scale levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}]","[{'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0402003,"Average endorphin-β levels at pretest and post-test were 571.80 ± 281.13 and 491.14 ± 272.14, respectively ( P  = 0.818).","[{'ForeName': 'Wita', 'Initials': 'W', 'LastName': 'Saraswati', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Airlangga Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Mochammad Rizalul', 'Initials': 'MR', 'LastName': 'Rosyiadi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Airlangga Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Ario', 'Initials': 'A', 'LastName': 'Imandiri', 'Affiliation': 'Department of Traditional Healer, Faculty of Vocations, Universitas Airlangga, Surabaya, Indonesia.'}]",Medical acupuncture,['10.1089/acu.2020.1425']
1715,33101575,Laser Acupuncture Effects on Speech and Social Interaction in Patients with Autism Spectrum Disorder.,"Objective:  Disorders of speech ability and social interaction are the most-common symptoms in children with autism spectrum disorder (ASD). Acupuncture, as an adjunctive therapy, is known to help improve speech ability and social interaction in children with this condition. One of the acupuncture modalities with minimal side-effects, and that is safe for children, is laser acupuncture or  laserpuncture . This study's aim was to determine laserpuncture's effects on speech ability and social interactions in patients with ASD.  Materials and Methods:  This randomized, double-blinded clinical trial involved 46 patients in 2 groups. All respondents qualified, and none dropped out. The treatment group ( n  = 23) received sensory-occupational integrative therapy and verum laserpuncture therapy and the control group ( n  = 23) received sensory-occupational integrative therapy and placebo laserpuncture. The groups' speech ability and social interaction were evaluated with a WeeFIM ®  questionnaire; parental reports were collected, using sensory profiles before and after treatment.  Results:  There were improvements in speech ability and social interaction in the verum laserpuncture group more than in the placebo group after treatment. Perception score was  P  < 0.001; odds ratio ( OR ): 18.8; 95% confidence interval (CI): 4.09-87.17. Expression score was  P  < 0.001;  OR:  50.2; 95% CI: 5.61-450.2. Social interaction score was  P  = 0.005;  OR: 7.2; 95% CI: 1.68-31.42. Parental report score was  P  = 0.765.  Conclusions:  Verum laserpuncture in this clinical trial improved speech ability and social interaction scores more effectively than placebo laserpuncture did in patients with ASD.",2020,There were improvements in speech ability and social interaction in the verum laserpuncture group more than in the placebo group after treatment.,"['children with this condition', 'children with autism spectrum disorder (ASD', 'Patients with Autism Spectrum Disorder', 'patients with ASD', '46 patients in 2 groups']","['Acupuncture', 'sensory-occupational integrative therapy and verum laserpuncture therapy and the control group ( n \u2009=\u200923) received sensory-occupational integrative therapy and placebo laserpuncture', 'placebo laserpuncture', 'placebo', 'Laser Acupuncture', 'Verum laserpuncture']","['speech ability and social interactions', 'Speech and Social Interaction', 'speech ability and social interaction scores', 'Perception score', 'Social interaction score', 'speech ability and social interaction', 'Expression score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",46.0,0.132725,There were improvements in speech ability and social interaction in the verum laserpuncture group more than in the placebo group after treatment.,"[{'ForeName': 'Imtiaz Amrinusantara', 'Initials': 'IA', 'LastName': 'Surapaty', 'Affiliation': 'Department of Medical Acupuncture, Faculty of Medicine, University of Indonesia, RSUPN Dr. Cipto Mangunkusumo National General Hospital, Central Jakarta, Indonesia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Simadibrata', 'Affiliation': 'Department of Medical Acupuncture, Faculty of Medicine, University of Indonesia, RSUPN Dr. Cipto Mangunkusumo National General Hospital, Central Jakarta, Indonesia.'}, {'ForeName': 'Ekky Sri', 'Initials': 'ES', 'LastName': 'Rejeki', 'Affiliation': 'RSPAD Gatot Soebroto, Central Jakarta, Indonesia.'}, {'ForeName': 'Irawan', 'Initials': 'I', 'LastName': 'Mangunatmadja', 'Affiliation': 'Divison of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, University of Indonesia, RSUPN Dr. Cipto Mangunkusumo, Central Jakarta, Indonesia.'}]",Medical acupuncture,['10.1089/acu.2020.1417']
1716,33101925,"Effectiveness a herbal medicine ( Sipjeondaebo-tang ) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial.","Background


Sipjeondaebo-tang  (SJDBT,  Shi-quan-da-bu-tang  in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS).
Methods


Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial.
Results


At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%;  P  =  0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale ( P  =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale ( P  =  0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale ( P  =  0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed.
Conclusion


This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.",2021,"However, the scores of the visual analogue scale ( P  =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale ( P  =  0.020, 0.480","['adults with chronic fatigue syndrome', 'Methods\n\n\nNinety-six eligible participants', 'patients with CFS']","['SJDBT', '\n\n\nSipjeondaebo-tang  (SJDBT,  Shi-quan-da-bu-tang  in Chinese', 'SJDBT or placebo', 'placebo', 'herbal medicine ( Sipjeondaebo-tang ']","['Safety', 'fatigue severity', 'visual analogue scale', 'response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment', 'Fatigue Severity Scale', 'severity of fatigue and qi deficiency', 'serious adverse events', 'fatigue severity, quality of life, and qi/blood/yin/yang deficiency', 'Chalder fatigue scale', 'response rate', 'Quality of life', 'severity of qi deficiency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0083104', 'cui_str': 'juzentaihoto'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}]",96.0,0.50139,"However, the scores of the visual analogue scale ( P  =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale ( P  =  0.020, 0.480","[{'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'National Agency for Development of Innovative Technologies in Korean Medicine, National Development Institute of Korean Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Sasang Constitutional Medicine, College of Korean Medicine, Woosuk University, Jeonju, Republic of Korea.'}, {'ForeName': 'Minwoo', 'Initials': 'M', 'LastName': 'Hwang', 'Affiliation': 'Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Integrative medicine research,['10.1016/j.imr.2020.100664']
1717,33101963,3D printing-assisted percutaneous fixation makes the surgery for scaphoid nonunion more accurate and less invasive.,"Purpose


The study was to explore whether the 3-dimensional printing guiding plate system could facilitate the modified procedure for arthroscopic treatment of nondisplaced scaphoid nonunion.
Methods


Patients, diagnosed with scaphoid nonunion without displacement, were randomly assigned into two groups. In Group A, the 3-dimensional printing guiding plate system was used for guiding fixation during the surgery. In Group B, fixation was performed with intra-operative fluoroscopy. The bone operation time was recorded during the surgery. The patients were evaluated before surgery and followed-up after six post-operative months, including motion ratio, strength ratio, Visual Analogue Scale, modified Mayo Scores, Patient Rated Wrist Evaluation scores, plain radiography and CT scan.
Results


Sixteen patients were recruited for the study. The average bone operation time in Group A was statistically shorter than that in Group B.
Conclusions


3-dimensional printing technique-assisted arthroscopic bone graft and fixation of scaphoid nonunion constitute an effective and accurate clinical treatment option.
The translational potential of this article


The concept and technique of 3D printing assisted percutaneous fixation introduced in this paper have the potential to be applied in a variety of operations requiring accurate percutaneous fixation, especially for the joint injuries.",2020,"The average bone operation time in Group A was statistically shorter than that in Group B.
Conclusions


3-dimensional printing technique-assisted arthroscopic bone graft and fixation of scaphoid nonunion constitute an effective and accurate clinical treatment option.
","['Methods\n\n\nPatients, diagnosed with scaphoid nonunion without displacement', 'Sixteen patients were recruited for the study']","['3-dimensional printing guiding plate system', '3D printing-assisted percutaneous fixation']","['bone operation time', 'average bone operation time', 'motion ratio, strength ratio, Visual Analogue Scale, modified Mayo Scores, Patient Rated Wrist Evaluation scores, plain radiography and CT scan']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0223724', 'cui_str': 'Bone structure of scaphoid'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone'}]","[{'cui': 'C0185131', 'cui_str': 'Operation on bone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",16.0,0.0166575,"The average bone operation time in Group A was statistically shorter than that in Group B.
Conclusions


3-dimensional printing technique-assisted arthroscopic bone graft and fixation of scaphoid nonunion constitute an effective and accurate clinical treatment option.
","[{'ForeName': 'Hua-Wei', 'Initials': 'HW', 'LastName': 'Yin', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun-Tao', 'Initials': 'JT', 'LastName': 'Feng', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bao-Fu', 'Initials': 'BF', 'LastName': 'Yu', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun-Dong', 'Initials': 'YD', 'LastName': 'Shen', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu-Dong', 'Initials': 'YD', 'LastName': 'Gu', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wen-Dong', 'Initials': 'WD', 'LastName': 'Xu', 'Affiliation': 'Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China.'}]",Journal of orthopaedic translation,['10.1016/j.jot.2020.01.007']
1718,33101964,Biomechanical comparison of four tibial fixation techniques for meniscal root sutures in posterior medial meniscus root repair: A porcine study.,"Objective


This study hypothesized that the suture anchor of tibial fixation method of PMMR repair technique is the main factor which reduce the gap formation or over displacement of tear site in initial healing, and then investigated the fixation stability of 4 different tibial fixations through cyclic and ultimate failure load testing of meniscal root sutures.
Methods


Twenty-four porcine tibiae with intact medial meniscus roots were randomly assigned into 4 groups: transosseous suture, washer, suture anchor, or screw with washer. Each sample underwent cyclic loading followed by a load-to-failure test. Displacement, maximum load to failure, stiffness, and elongation at failure load were recorded.
Results


The maximum average load and displacement at failure for each of the repair groups were as follows: transosseous suture, 232.8 N and 12.16 mm; washer, 189.9 N and 21.5 mm; suture anchor, 140.6 N and 13.8 mm; and screw with washer, 167.9 N and 18.9 mm. The maximum stiffness values for each of the repair groups were as follows: transosseous suture, 19.5 ± 0.7 N/mm; washer, 21.5 ± 1.4 N/mm; suture anchor, 13.8 ± 0.7 N/mm; and screw with washer, 18.9 ± 3.9 N/mm. The mean elongation across the repairs for each of the repair groups after 1000 loading cycles was: transosseous suture, 3.74 ± 0.28 mm; washer, 3.04 ± 0.13 mm; suture anchor, 2.25 ± 0.33 mm; and screw with washer, 2.43 ± 0.19 mm. The mean elongation was significantly less with the suture anchor than with the other techniques ( p  < .05).
Conclusion


Under physiological loading, our results indicate that a slower rehabilitation program with limited flexion and only partial weight bearing is advised when using a suture anchor because of the lower maximum load and stiffness.
The translational potential of this article


Tibial fixation using a washer or a screw with a washer is an effective and cost-saving technique when an option is required with high stiffness and low displacement at failure.",2020,"The mean elongation was significantly less with the suture anchor than with the other techniques ( p  < .05).
","['Methods\n\n\nTwenty-four porcine tibiae with intact medial meniscus roots', 'posterior medial meniscus root repair']","['transosseous suture, washer, suture anchor, or screw with washer', 'meniscal root sutures', 'PMMR repair technique', 'tibial fixation techniques']","['Displacement, maximum load to failure, stiffness, and elongation at failure load', 'mean elongation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0707235,"The mean elongation was significantly less with the suture anchor than with the other techniques ( p  < .05).
","[{'ForeName': 'Shen-Han', 'Initials': 'SH', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Tsu-Te', 'Initials': 'TT', 'LastName': 'Yeh', 'Affiliation': 'Department of Orthopedic Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Biomedical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.'}, {'ForeName': 'Alexander T H', 'Initials': 'ATH', 'LastName': 'Wu', 'Affiliation': 'The PhD Program for Translational Medicine, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Guoan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Bioengineering Laboratory, Department of Orthopedic Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Chih-Hwa', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chian-Her', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jia-Lin', 'Initials': 'JL', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}]",Journal of orthopaedic translation,['10.1016/j.jot.2020.01.006']
1719,33102217,An Intraoperative Model for Predicting Survival and Deciding Therapeutic Schedules: A Comprehensive Analysis of Peritoneal Metastasis in Patients With Advanced Gastric Cancer.,"Background and Objective:  No specialized prognostic model for patients with gastric cancer with peritoneal metastasis (GCPM) exists for intraoperative clinical decision making. This study aims to establish a new prognostic model to provide individual treatment decisions for patients with GCPM.  Method:  This retrospective analysis included 324 patients with GCPM diagnosed pathologically by laparoscopy from January 2007 to January 2018 who were randomly assigned to different sets (227 in the training set and 97 in the internal validation set). A nomogram was established from preoperative and intraoperative variables determined by a Cox model. The predictive ability and clinical applicability of the PM nomogram (PMN) were compared with the 15th Japanese Classification of Gastric Carcinoma (JCGC) Staging Guidelines for PM (P1abc). Additional external validation was performed using a dataset ( n  = 39) from the First Affiliated Hospital of University of Science and Technology of China.  Results:  The median survival time was 8 (range, 1-90) months. In the training set, each PMN substage had significantly different survival curves ( P  < 0.001), and the PMN was superior to the P1abc based on the results of time-dependent receiver operating characteristic curve, C-index, Akaike information criterion and likelihood ratio chi-square analyses. In the internal and external validation sets, the PMN was also better than the P1abc in terms of its predictive ability. Of the PMN1 patients, those undergoing palliative resection had better overall survival (OS) than those undergoing exploratory surgery ( P  < 0.05). Among the patients undergoing exploratory surgery, those who received chemotherapy exhibited better OS than those who did not ( P  < 0.05). Among the patients who received palliative resection, only PMN1 patients exhibited better OS following chemotherapy ( P  < 0.05).  Conclusion:  We developed and validated a simple, specific PM model for patients with GCPM that can predict prognosis well and guide treatment decisions.",2020,"Among the patients who received palliative resection, only PMN1 patients exhibited better OS following chemotherapy ( P  < 0.05).  ","['Patients With Advanced Gastric Cancer', '324 patients with GCPM diagnosed pathologically by laparoscopy from January 2007 to January 2018 who were randomly assigned to different sets (227 in the training set and 97 in the internal validation set', 'patients with gastric cancer with peritoneal metastasis (GCPM', 'patients with GCPM']","['palliative resection', 'chemotherapy']","['survival curves', 'overall survival (OS', 'median survival time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",324.0,0.0394454,"Among the patients who received palliative resection, only PMN1 patients exhibited better OS following chemotherapy ( P  < 0.05).  ","[{'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Yu', 'Initials': 'ZY', 'LastName': 'Liu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Division of Life Sciences and Medicine, Department of Gastrointestinal Surgery, The First Affiliated Hospital of University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Ya-Jun', 'Initials': 'YJ', 'LastName': 'Zhao', 'Affiliation': 'Division of Life Sciences and Medicine, Department of Gastrointestinal Surgery, The First Affiliated Hospital of University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Si-Jin', 'Initials': 'SJ', 'LastName': 'Que', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.550526']
1720,33111563,An Evaluation of an Innovative Exercise to Relieve Chronic Low Back Pain in Sedentary Workers.,"OBJECTIVE


The purpose of the study was to examine the effectiveness of a novel supported dynamic lumbar extension with the abdominal drawing-in maneuver (ADIM) technique on stature change, deep abdominal muscle activity, trunk muscle fatigue, and pain intensity during prolonged sitting in chronic low back pain (CLBP) participants.
BACKGROUND


Prolonged sitting can cause trunk muscle fatigue from continuous contraction of deep trunk muscles in seated postures. Deficiency of activity of deep muscles can reduce muscular support of the spine, causing stress on spinal structures, which could result in pain.
METHOD


Thirty participants with CLBP were randomly allocated: (a) control-sitting without exercise, and (b) intervention-supported dynamic lumbar extension with the ADIM technique.
RESULTS


Compared to the intervention condition, the control condition demonstrated significantly greater deterioration in stature change, increased levels of deep trunk muscle fatigue, and an increase in pain during prolonged sitting.
CONCLUSION


The supported dynamic lumbar extension with the ADIM technique appears to provide a protective effect on detrimental stature change and deep trunk muscle fatigue. In addition, it prevented an increase in pain intensity during prolonged sitting in people with CLBP.
APPLICATION


Sedentary behavior harms health, particularly affecting the lower back. Clinicians can use the intervention to induce dynamic lumbar movement, and this exercise can maintain deep trunk muscle activity during prolonged sitting, thereby helping to prevent low back pain (LBP) problems.",2020,"Compared to the intervention condition, the control condition demonstrated significantly greater deterioration in stature change, increased levels of deep trunk muscle fatigue, and an increase in pain during prolonged sitting.
","['Thirty participants with CLBP', 'Sedentary Workers', 'chronic low back pain (CLBP) participants']","['novel supported dynamic lumbar extension with the abdominal drawing-in maneuver (ADIM) technique', 'Innovative Exercise', 'control-sitting without exercise, and (b) intervention-supported dynamic lumbar extension with the ADIM technique']","['stature change, deep abdominal muscle activity, trunk muscle fatigue, and pain intensity', 'pain intensity', 'deterioration in stature change, increased levels of deep trunk muscle fatigue', 'detrimental stature change and deep trunk muscle fatigue', 'pain']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0236781,"Compared to the intervention condition, the control condition demonstrated significantly greater deterioration in stature change, increased levels of deep trunk muscle fatigue, and an increase in pain during prolonged sitting.
","[{'ForeName': 'Pongsatorn', 'Initials': 'P', 'LastName': 'Saiklang', 'Affiliation': '26684 Khon Kaen University, Thailand.'}, {'ForeName': 'Rungthip', 'Initials': 'R', 'LastName': 'Puntumetakul', 'Affiliation': '26684 Khon Kaen University, Thailand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Selfe', 'Affiliation': '5289 Manchester Metropolitan University, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Yeowell', 'Affiliation': '5289 Manchester Metropolitan University, UK.'}]",Human factors,['10.1177/0018720820966082']
1721,33111575,An Attachment-Based Parental Capacity Assessment to Orient Decision-Making in Child Protection Cases: A Randomized Control Trial.,"Two parenting capacity assessment (PCA) protocols, with a short parent-child intervention embedded in each protocol, evaluated the potential for enhanced parenting to orient child placement decision. Parents ( n  = 69), with substantiated reports of maltreatment by child protective services, and their children (0-6) were randomly assigned to one of two PCAs with either the Attachment Video-feedback (PCA-AVI) or a psychoeducational intervention (PCA-PI) as the embedded intervention component. The PCA-AVI group showed the highest increases in parent-child interaction quality at post-test. Also, at PCA completion, evaluators' conclusions about the parents' capacity to care for both PCA groups were associated with parent-child interactive improvements at post-test, the court's placement decision at post-test, and child placement one year later. However, only conclusions drawn by PCA-AVI evaluators were predictive of child re-reports of maltreatment in the year following PCA. PCAs, relying on short attachment interventions to assess the potential for enhanced parenting, are promising tools to orient child placement decisions.",2020,"PCAs, relying on short attachment interventions to assess the potential for enhanced parenting, are promising tools to orient child placement decisions.","['Parents ( n  = 69), with substantiated reports of maltreatment by child protective services, and their children (0-6', 'Child Protection Cases']",['PCAs with either the Attachment Video-feedback (PCA-AVI) or a psychoeducational intervention (PCA-PI'],['parent-child interaction quality'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0189556,"PCAs, relying on short attachment interventions to assess the potential for enhanced parenting, are promising tools to orient child placement decisions.","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Cyr', 'Affiliation': 'Department of Psychology, 229169Université du Québec à Montréal, Québec, Canada.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Dubois-Comtois', 'Affiliation': 'Department of Psychology, 14847Université du Québec à Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Paquette', 'Affiliation': ""Institut Universitaire Jeunes en Difficulté, 49987CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Québec, Canada.""}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': ""Institut Universitaire Jeunes en Difficulté, 49987CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Québec, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bigras', 'Affiliation': 'Department of Psychology, 229169Université du Québec à Montréal, Québec, Canada.'}]",Child maltreatment,['10.1177/1077559520967995']
1722,33111587,The Effects of 10-Day Exogenous Ketone Consumption on Repeated Time Trial Running Performances: A Randomized-Control Trial.,"INTRODUCTION


The effects of ketone salt supplementation on repeated short-distance running time trial (TT) performance in well-trained subjects remain unknown.
PURPOSE


To determine the effects of 10-day exogenous ketone salt supplementation on two consecutive 800 m running TTs in endurance-trained subjects.
METHODS


Male and female subjects were randomly allocated to one of the following groups: Ketone (KET) ( n  = 16) or placebo (CON) ( n  = 16) (8 m, 8f per group). Subjects underwent two consecutive 800 m TTs before and after a 10-day treatment on a self-propelled treadmill. Time-to-completion of the first (TT1) and second (TT2) TT, the average time-to-completion (TT AVG ), and blood lactate response during each TT was measured pre-post-treatment. Changes in blood ketone levels in response to a single dosing were measured pre- and post-treatment. Data was analyzed with a mixed factorial ANOVA with significance set to  p  < 0.05.
RESULTS


KET demonstrated a faster TT AVG  from pre- to post-treatment (-6.1 ± 8.9 s;  p  = 0.02) while CON showed no change. At pre- and post-treatment, CON showed no acute changes in blood ketones after a single-dosing while KET demonstrated a significant increases (Pretreatment = +0.4 ± 0.3 mmol/L;  p  < 0.001; Post-Treatment = +0.4 ± 0.4 mmol/L;  p  < 0.001). These acute single-dosing responses in blood ketone levels for KET did not change between pre- and post-treatment. There were no interactions for blood lactate response to exercise or fatigue index.
CONCLUSIONS


In trained subjects, 10 days of ketone salt supplementation does not affect performance in an initial bout of short-distance running, such as during TT1. However, ergogenic effects may be observed under fatigue conditions for example during a repeated running bout.",2020,These acute single-dosing responses in blood ketone levels for KET did not change between pre- and post-treatment.,"['two consecutive 800\u2009m running TTs in endurance-trained subjects', 'well-trained subjects remain unknown', 'Male and female subjects', 'Running Performances']","['10-day exogenous ketone salt supplementation', '10-Day Exogenous Ketone Consumption', 'ketone salt supplementation', 'placebo (CON', 'Ketone (KET']","['blood lactate response to exercise or fatigue index', 'faster TT AVG', 'blood ketone levels', 'blood ketones', 'repeated short-distance running time trial (TT) performance', 'Time-to-completion of the first (TT1) and second (TT2) TT, the average time-to-completion (TT AVG ), and blood lactate response']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.115814,These acute single-dosing responses in blood ketone levels for KET did not change between pre- and post-treatment.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jo', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Silva Ms', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Alexandra T', 'Initials': 'AT', 'LastName': 'Auslander PhD', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Arreglado Ms', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Elam PhD', 'Affiliation': 'Department of Human Nutrition and Food Science, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Osmond Ms', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Steinberg Ms', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Michael W H', 'Initials': 'MWH', 'LastName': 'Wong Ms', 'Affiliation': 'Department of Kinesiology and Health Promotion, Human Performance Research Laboratory, California State Polytechnic University Pomona, Pomona, CA, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1838022']
1723,33111581,Feasibility of Beans/Bran Enriching Nutritional Eating For Intestinal Health & Cancer Including Activity for Longevity: A Pilot Trial to Improve Healthy Lifestyles among Individuals at High Risk for Colorectal Cancer.,"PURPOSE


Examine the feasibility and preliminary effects of a lifestyle intervention of rice bran plus navy bean supplementation, and physical activity (PA) education on intake of fiber and whole grains, and PA levels.
DESIGN


Randomized-controlled, single-blinded.
SETTING


Academic institution and free-living.
SUBJECTS


Adults >18 years, with ≥1 adenomatous polyp removed within 3 years.
INTERVENTION


Participants received powder and pre-prepared meals and snacks that contained either rice bran (30 g/day) plus navy bean (30 g/day), or Fibersol-2 ®  (10 g/day), for 12-weeks. All participants received a 1-hour (PA) education session.
MEASURES


Feasibility was assessed by recruitment and retention rates, and compliance to the study foods and procedures. Three-day food logs were analyzed using Nutritionist Pro™ to estimate fiber intake, and the Automated Self-Administered 24-hour (ASA24 ® ) Dietary Assessment Tool calculated Healthy Eating Index (HEI) whole grain and total scores. PA was measured using an ActivPAL™ accelerometer.
ANALYSIS


Continuous data were summarized as median, range, and percent change from baseline to post-intervention.
RESULTS


N = 20 (86.9%) completed the intervention. Compliance was 92% in the rice bran plus navy bean versus 89% in Fibersol-2 ® . Navy bean consumption increased from 2 g/day to 30 g/day, and rice bran from 0 g/day to 30 g/day. Fiber intake (g/day) increased by 73% versus 82%, HEI whole grain improved by 270% versus 37%, and HEI total improved by 10% versus 9.1% in rice bran plus navy bean and Fibersol-2 ® , respectively. Total PA (MET-hours/day) showed minimal change for intervention (+0.04%) and control (+4%).
CONCLUSION


Findings merit a larger trial of rice bran plus navy bean and PA to evaluate efficacy for dietary and cancer prevention-related outcomes.",2020,"Total PA (MET-hours/day) showed minimal change for intervention (+0.04%) and control (+4%).
","['Longevity', 'Healthy Lifestyles among Individuals at High Risk for Colorectal Cancer', 'Academic institution and free-living', 'Adults >18\u2009years, with ≥1 adenomatous polyp removed within 3\u2009years']","['Beans/Bran Enriching Nutritional Eating', 'lifestyle intervention of rice bran plus navy bean supplementation, and physical activity (PA) education', 'powder and pre-prepared meals and snacks that contained either rice bran (30\u2009g/day) plus navy bean (30\u2009g/day), or Fibersol-2 ®', 'rice bran plus navy bean and PA', '1-hour (PA) education session']","['Automated Self-Administered 24-hour (ASA24 ® ) Dietary Assessment Tool calculated Healthy Eating Index (HEI) whole grain and total scores', 'Navy bean consumption', 'Fiber intake', 'Compliance', 'HEI total', 'intake of fiber and whole grains, and PA levels', 'recruitment and retention rates, and compliance to the study foods and procedures', 'HEI whole grain']","[{'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous polyp'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0982374', 'cui_str': 'RICE BRAN'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0307294,"Total PA (MET-hours/day) showed minimal change for intervention (+0.04%) and control (+4%).
","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leach', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, CO, USA.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Baxter', 'Affiliation': 'Colorado School of Public Health, Colorado State University, CO, USA.'}, {'ForeName': 'Melanie N', 'Initials': 'MN', 'LastName': 'Beale', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, CO, USA.'}, {'ForeName': 'Hillary V', 'Initials': 'HV', 'LastName': 'Smith', 'Affiliation': 'Department of Environmental Health and Radiological Sciences, Colorado State University, CO, USA.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Colorado School of Public Health, Colorado State University, CO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hibbs-Shipp', 'Affiliation': 'Department of Environmental Health and Radiological Sciences, Colorado State University, CO, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Ryan', 'Affiliation': 'Colorado School of Public Health, Colorado State University, CO, USA.'}]",Integrative cancer therapies,['10.1177/1534735420967101']
1724,33111942,Repeated Injections of Low-Dose Nerve Growth Factor (NGF) in Healthy Humans Maintain Muscle Pain and Facilitate Ischemic Contraction-Evoked Pain.,"OBJECTIVE


Nerve growth factor (NGF) is essential for generating and potentiating pain responses. This double-blinded crossover study assessed NGF-evoked pain in healthy humans after repeated NGF injections in the tibialis anterior (TA) muscle compared with control injections of isotonic saline.
SUBJECTS


Twenty healthy subjects participated in two experimental phases; each consisted of seven sessions over 21 days.
METHODS


At day 0, day 2, and day 4, a low-dose NGF (1 µg) was injected. Data on daily self-reported muscle pain (using a Likert scale) were collected. Data on pressure pain thresholds (PPTs), pain evoked by nonischemic and ischemic muscle contractions (using a numerical rating scale [NRS]), pressure pain detection (PDT), and pain tolerance thresholds (PTTs) to cuff algometry were recorded before day 0 and at 1, 2, 4, 7, 10, and 21 days after the first injection. Temporal summation of pain (TSP) and conditioned pain modulation (CPM) were recorded to assess central pain mechanisms.
RESULTS


Likert scores remained elevated for 9 days after NGF injection (P<0.05). PPTs at the TA muscle were decreased at day 1 until day 7 after NGF injection compared with day 0 (P=0.05). In subjects presenting with NGF-induced muscle hyperalgesia, pain NRS scores evoked by nonischemic contractions were higher after NGF injection at day 4 and day 7 (P<0.04) compared with the control condition. At all time points, higher pain NRS scores were found with ischemic compared with nonischemic contractions (P<0.05). The pain NRS after ischemic contractions was elevated following prolonged NGF hyperalgesia at day 7 compared with the control condition and day 0 (P<0.04). The PDT, PTT, TSP, and CPM remained unchanged during the period of NGF-induced hyperalgesia.
CONCLUSIONS


Repeated low-dose NGF injections maintain muscle pain and potentiate pain evoked by ischemic contractions during prolonged NGF hyperalgesia.",2020,The pain NRS after ischemic contractions was elevated following prolonged NGF hyperalgesia at day 7 compared with the control condition and day 0,"['Twenty healthy subjects participated in two experimental phases; each consisted of seven sessions over 21 days', 'Healthy Humans', 'healthy humans after repeated']","['Low-Dose Nerve Growth Factor (NGF', 'isotonic saline', 'Nerve growth factor (NGF', 'NGF-evoked pain', 'NGF injections']","['muscle hyperalgesia, pain NRS scores evoked by nonischemic contractions', 'pain NRS after ischemic contractions', 'muscle pain', 'Temporal summation of pain (TSP) and conditioned pain modulation (CPM', 'pressure pain thresholds (PPTs), pain evoked by nonischemic and ischemic muscle contractions (using a numerical rating scale [NRS]), pressure pain detection (PDT), and pain tolerance thresholds (PTTs) to cuff algometry', 'pain NRS scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]",20.0,0.139247,The pain NRS after ischemic contractions was elevated following prolonged NGF hyperalgesia at day 7 compared with the control condition and day 0,"[{'ForeName': 'Line Bay', 'Initials': 'LB', 'LastName': 'Sørensen', 'Affiliation': 'Department of Health Science and technology, Center for Neuroplasticity and Pain (CNAP), Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Biomedicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Neuroscience Institute, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Department of Health Science and technology, Center for Neuroplasticity and Pain (CNAP), Aalborg University, Aalborg, Denmark.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa315']
1725,33111950,Thoracic Paravertebral Blockade Reduces Chronic Postsurgical Pain in Breast Cancer Patients: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effect of multilevel single-shot thoracic paravertebral blockade (PVB) on the occurrence of chronic postsurgical pain (CPSP) in patients undergoing breast cancer surgery.
DESIGN


A randomized controlled trial with two parallel groups.
SETTING


A tertiary hospital.
METHODS


Patients scheduled for breast cancer surgery were randomized to receive either ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing (the control group). Surgery was then performed under general anesthesia. Patients were followed up for 12 months after surgery. The primary end point was incidence of CPSP at six months after surgery.
RESULTS


A total of 218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively. The incidence of CPSP at six months was significantly lower in the PVB group (12.5% [13/104]) than in the control group (24.0% [25/104], relative risk = 0.52, 95% CI = 0.28-0.96, P = 0.031). Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively). The percentages of patients with neuropathic pain were also lower in the PVB group than the control group at both six and 12 months after surgery (P = 0.016 and 0.028, respectively). Adverse events did not differ between groups.
CONCLUSIONS


For patients undergoing breast cancer surgery, multilevel single-shot PVB reduces the incidence of CPSP at six months; it also improves early postoperative analgesia and reduces neuropathic pain at six and 12 months after surgery.",2020,"Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively).","['patients undergoing breast cancer surgery', '218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively', 'Patients scheduled for breast cancer surgery', 'Breast Cancer Patients', 'A tertiary hospital']","['multilevel single-shot thoracic paravertebral blockade (PVB', 'ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing', 'Thoracic Paravertebral Blockade', 'PVB']","['Chronic Postsurgical Pain', 'Adverse events', 'Pain scores', 'incidence of CPSP', 'neuropathic pain', 'chronic postsurgical pain (CPSP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",218.0,0.183769,"Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively).","[{'ForeName': 'Zeng-Mao', 'Initials': 'ZM', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Mu-Han', 'Initials': 'MH', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Shao', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xue-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Biostatics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa270']
1726,33111977,The Effects of Clinical and Home-based Physiotherapy Programs in Secondary Head and Neck Lymphedema.,"OBJECTIVES/HYPOTHESIS


To determine the effects of complex decongestive physiotherapy (CDP) and home programs on external lymphedema, staging of lymphedema, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema.
STUDY DESIGN


A prospective randomized controlled study.
METHODS


Twenty-one patients were randomly divided into three groups: CDP (n:7), home program (n:7), and control (n:7). Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging of lymphedema, and fibrosis. A 3D scanner and a software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness.
RESULTS


The severity and volume of lymphedema decreased in the CDP program group (P < .05). Besides, external lymphedema and fibrosis at submental region were decreased in both CDP program and home program groups (P < .05).
CONCLUSIONS


While the benefits of home program are limited, a CDP program may be more effective in the management of lymphedema and fibrosis in patients diagnosed with head and neck cancer. The clinical trial registration number: NCT04286698, date: 02/25/2020, retrospectively registered.
LEVEL OF EVIDENCE


4 Laryngoscope, 2020.",2020,The severity and volume of lymphedema decreased in the CDP program group (P < .05).,"['Secondary Head and Neck Lymphedema', 'patients diagnosed with head and neck cancer', 'head and neck lymphedema', 'Twenty-one patients']","['complex decongestive physiotherapy (CDP', 'CDP (n:7), home program (n:7), and control (n:7', 'Clinical and Home-based Physiotherapy Programs']","['external lymphedema and fibrosis at submental region', 'severity and volume of lymphedema']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0931905', 'cui_str': 'Submental triangle structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",21.0,0.0228025,The severity and volume of lymphedema decreased in the CDP program group (P < .05).,"[{'ForeName': 'Kadirhan', 'Initials': 'K', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Izmir Bakircay University, Izmir, Turkey.'}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Keser', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Duzlu', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Ozge P', 'Initials': 'OP', 'LastName': 'Erpolat', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Uluc', 'Initials': 'U', 'LastName': 'Saranli', 'Affiliation': 'Department of Computer Engineering, Faculty of Engineering, Middle East Technical University, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Tutar', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}]",The Laryngoscope,['10.1002/lary.29205']
1727,33111980,Ozone as Adjuvant Support in the Treatment of COVID-19: A Preliminary Report of Probiozovid Trial.,"RATIONALE


The evaluation of new therapeutic resources against COVID-19 represents a priority in clinical research considering the minimal options currently available.
OBJECTIVES


To evaluate the adjuvant use of systemic oxygen-ozone administration in the early control of disease progression in patients with COVID-19 pneumonia.
METHODS


PROBIOZOVID is an ongoing, interventional, randomized, prospective, double-arm trial enrolling patient with COVID-19 pneumonia. From a total of 85 patients screened, 28 were recruited. Patients were randomly divided into ozone-autohemotherapy group (14) and control group (14). The procedure consisted in a daily double-treatment with systemic Oxygen-Ozone administration for 7 days. All patients were treated with ad interim best available therapy.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was delta in the number of patients requiring orotracheal-intubation despite treatment. Secondary outcome was the difference of mortality between the two groups. Moreover, haematological parameters were compared before and after treatment. No differences in the characteristics between groups were observed at baseline. As a preliminary report we have observed that one patient for each group needed intubation and was transferred to ITU. No deaths were observed at 7-14 days of follow up. Thirty-day mortality was 8,3% for ozone group and 10% for controls. Ozone therapy didn't significantly influence inflammation markers, haematology profile and lymphocyte subpopulations of patients treated. Ozone therapy had an impact on the need for the ventilatory support, although didn't reach statistical significance. Finally, no adverse events related to the use of ozone-autohemotherapy were reported.
CONCLUSIONS


Preliminary results, although not showing statistically significant benefits of ozone on COVID-19, did not report any toxicity. This article is protected by copyright. All rights reserved.",2020,"Ozone therapy had an impact on the need for the ventilatory support, although didn't reach statistical significance.","['patients with COVID-19 pneumonia', 'COVID-19', 'enrolling patient with COVID-19 pneumonia', '85 patients screened, 28 were recruited']","['Ozone therapy', 'systemic oxygen-ozone administration', 'ozone-autohemotherapy', 'systemic Oxygen-Ozone administration']","['inflammation markers, haematology profile and lymphocyte subpopulations', 'difference of mortality', 'deaths', 'Thirty-day mortality', 'toxicity', 'haematological parameters', 'delta in the number of patients requiring orotracheal-intubation despite treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",28.0,0.114293,"Ozone therapy had an impact on the need for the ventilatory support, although didn't reach statistical significance.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Araimo', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Imperiale', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tordiglione', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ceccarelli', 'Affiliation': 'Azienda Universitaria-Ospedaliera Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Borrazzo', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Alessandri', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Santinelli', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giuseppe Pietro', 'Initials': 'GP', 'LastName': 'Innocenti', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pinacchio', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mauro', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gregorio Egidio', 'Initials': 'GE', 'LastName': 'Recchia', 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Zancla', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calò', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Poscia', 'Affiliation': 'Azienda Universitaria-Ospedaliera Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Ruberto', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': ""d'Ettorre"", 'Affiliation': 'Department of Public Health and Infectious Diseases Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bilotta', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mastroianni', 'Affiliation': 'Azienda Universitaria-Ospedaliera Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pugliese', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sapienza University of Rome, Rome, Italy.'}]",Journal of medical virology,['10.1002/jmv.26636']
1728,33112184,"Efficacy and safety of weekly carfilzomib (70 mg/m 2 ), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies.","The regimen of carfilzomib, daratumumab, and dexamethasone (KdD) shows activity in patients with relapsed/refractory multiple myeloma. KdD at the twice-weekly 56 mg/m 2  carfilzomib dose (KdD56) was used in the randomized phase 3 CANDOR study (NCT03158688), whereas KdD at the once-weekly 70 mg/m 2  carfilzomib dose (KdD70) was used in the phase 1 b EQUULEUS study (NCT01998971). We analyzed efficacy data from comparable CANDOR and EQUULEUS patients using inverse probability of treatment weighting (IPTW)-adjusted models. These weights were calculated from propensity scores derived to balance prespecified baseline covariates. The side-by-side and adjusted comparisons showed similar efficacy for overall response rates and progression-free survival in the two groups, with a series of sensitivity analyses showing consistent findings. Safety data were generally consistent with the known safety profiles of each individual drug. Once-weekly KdD70 is comparable to twice-weekly KdD56 in terms of efficacy and safety while being a more convenient dosing option.",2020,"The side-by-side and adjusted comparisons showed similar efficacy for overall response rates and progression-free survival in the two groups, with a series of sensitivity analyses showing consistent findings.",['patients with relapsed/refractory multiple myeloma'],"['dexamethasone, and daratumumab (KdD70', 'carfilzomib, daratumumab, and dexamethasone (KdD', 'carfilzomib']","['efficacy and safety', 'Efficacy and safety', 'overall response rates and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0266668,"The side-by-side and adjusted comparisons showed similar efficacy for overall response rates and progression-free survival in the two groups, with a series of sensitivity analyses showing consistent findings.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': ""Service d'Hématologie et Thérapie cellulaire, CHU and Inserm, Poitiers, France.""}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Chou', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Epworth Healthcare and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Shelekhova', 'Affiliation': 'Clinic of Professional Pathology, Saratov, Russian Federation.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Khurana', 'Affiliation': 'Clinical Development, Oncology, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jianqi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Obreja', 'Affiliation': 'Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Hematology and Oncology, Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut Català d'Oncologia and Josep Carreras Research Leukaemia Institute, Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siegel', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1832672']
1729,33112193,Owner evaluation of quality of life and mobility in osteoarthritic cats treated with amantadine or placebo.,"OBJECTIVES


The aim of the study was to determine if amantadine improves owner-identified mobility impairment and quality of life associated with osteoarthritis in cats.
METHODS


Using a blinded, placebo-controlled, randomized, crossover design, 13 healthy client-owned cats with clinical and radiographic evidence of osteoarthritis and owner-identified mobility impairment were studied. Cats received 5 mg/kg amantadine or placebo q24h PO for 3 weeks each with no washout period between. Locomotor activity was continuously assessed with a collar-mounted activity monitor system, and owners chose and rated two mobility-impaired activities using a client-specific outcome measures (CSOM) questionnaire on a weekly basis. Locomotor activity on the third treatment week was analyzed with two-tailed paired  t -tests. The CSOM scores were analyzed using a mixed-effect model and the Bonferroni post-hoc test. Owner-perceived changes in quality of life were compared between treatments using the χ 2  test. Statistical significance was set at  P < 0.05.
RESULTS


Mean ± SD activity counts during the third week of each treatment were significantly lower with amantadine (240,537 ± 53,880) compared with placebo (326,032 ± 91,759). CSOM scores assigned by the owners were significantly better with amantadine on the second (3 ± 1) and third (3 ± 1) weeks compared with placebo (5 ± 2 and 5 ± 1, respectively). A significantly greater proportion of owners reported improvement in quality of life with amantadine compared with placebo.
CONCLUSIONS AND RELEVANCE


Amantadine significantly decreased activity, but improved owner-identified impaired mobility and owner-perceived quality of life in cats with osteoarthritis. Amantadine appears to be an option for the symptomatic treatment of osteoarthritis in cats.",2020,"A significantly greater proportion of owners reported improvement in quality of life with amantadine compared with placebo.
","['osteoarthritis in cats', '13 healthy client-owned cats with clinical and radiographic evidence of osteoarthritis and owner-identified mobility impairment were studied', 'cats with osteoarthritis', 'cats', 'osteoarthritic cats treated with']","['amantadine', 'amantadine or placebo q24h PO', 'amantadine or placebo', 'placebo', 'Amantadine']","['mobility and owner-perceived quality of life', 'Locomotor activity', 'SD activity counts', 'quality of life and mobility', 'quality of life', 'CSOM scores']","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1275548', 'cui_str': 'Every twenty four hours'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",13.0,0.0640364,"A significantly greater proportion of owners reported improvement in quality of life with amantadine compared with placebo.
","[{'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Shipley', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Flynn', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tucker', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Wendt-Hornickle', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Baldo', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almeida', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Allweiler', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}, {'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Guedes', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, USA.'}]",Journal of feline medicine and surgery,['10.1177/1098612X20967639']
1730,33112245,Effects of Interactivity on Recall of Health Information: Experimental Study.,"BACKGROUND


Information provided in an interactive way is believed to be engaging because users can actively explore the information. Yet empirical findings often contradict this assumption. Consequently, there is still little known about whether and how interactivity affects communication outcomes such as recall.
OBJECTIVE


The aim of this study was to investigate mechanisms through which interactivity affects recall of online health information. We tested whether and how cognitive involvement, perceived active control, and cognitive load mediate the effects of interactivity on recall. In addition, we examined need for cognition and health literacy as potential moderators of the mediation effects. Given the increasing popularity of dietary supplement use, our health website focused on this topic.
METHODS


In an online between-subjects experiment (n=983), participants were randomly assigned to control condition (no interactive features), moderate interactivity (dropdown menus), and high interactivity (dropdown menus and responsive infographics). Two weeks before the experiment, background characteristics and moderating variables were measured. During website visit, data on users' online behavior were collected. Recall was measured postexposure.
RESULTS


Participants recalled significantly less information in the moderate (mean 3.48 [SD 2.71]) and high (mean 3.52 [SD 2.64]) interactivity conditions compared with the control condition (mean 5.63 [SD 2.18]). In the mediation analysis, we found direct, negative effects of moderate (b=-2.25, 95% CI -2.59 to -1.90) and high (b=-2.16, 95% CI -2.51 to -1.81) levels of interactivity on recall as well. In the relationship between interactivity and recall, cognitive involvement had a partial negative mediation effect (moderate interactivity: b=-.20; 95% CI -0.31 to -0.10; high interactivity: b=-.21, 95% CI -0.33 to -0.10) and perceived active control had a partial positive mediation effect (moderate interactivity: b=.28, 95% CI 0.18 to 0.40; high interactivity: b=.27, 95% CI 0.16 to 0.40).
CONCLUSIONS


Interactivity decreased recall. In addition, through interactivity participants were less involved with the content of the information, yet they felt they had more control over the information. These effects were stronger in the high need for cognition and high health literate groups compared with their counterparts.",2020,"RESULTS


Participants recalled significantly less information in the moderate (mean 3.48 [SD 2.71]) and high (mean 3.52 [SD 2.64]) interactivity conditions compared with the control condition (mean 5.63 [SD 2.18]).",[],"['control condition (no interactive features), moderate interactivity (dropdown menus), and high interactivity (dropdown menus and responsive infographics']",['partial positive mediation effect'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.104445,"RESULTS


Participants recalled significantly less information in the moderate (mean 3.48 [SD 2.71]) and high (mean 3.52 [SD 2.64]) interactivity conditions compared with the control condition (mean 5.63 [SD 2.18]).","[{'ForeName': 'Emília Margit', 'Initials': 'EM', 'LastName': 'Pajor', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Sander Matthijs', 'Initials': 'SM', 'LastName': 'Eggers', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Oenema', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}]",Journal of medical Internet research,['10.2196/14783']
1731,33106167,"Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial.","OBJECTIVES


General: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patients Specific: a. To identify the appropriate effective dose of CP therapy in severe patients b. To identify the efficacy of the therapy with their end point based on clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality c. To assess the clinical improvement after CP transfusion in severe COVID-19 patients d. To assess the laboratory improvement after CP transfusion in severe COVID-19 patients TRIAL DESIGN: This is a multicentre, multi-arm phase II Randomised Controlled Trial.
PARTICIPANTS


Age and sex matched COVID-19 positive (by RT-PCR) severe cases will be enrolled in this trial. Severe case is defined by the World Health Organization (W.H.O) clinical case definition. The inclusion criteria are 1. Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological (X-ray or CT scan) evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND/OR 5. Criteria 1 to 4 AND or patient in ventilator support Patients' below18 years, pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded. Patients will be enrolled at Bangabandhu Sheikh Mujib Medical University (BSMMU) hospital, Dhaka medical college hospital (DMCH) and Mugda medical college hospital (MuMCH). Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA antibody titre will be done at BSMMU and CMBT and neutralizing antibody titre will be checked in collaboration with the University of Oxford. Patients who have recovered from COVID-19 will be recruited as donors of CP. The recovery criteria are normality of body temperature for more than 3 days, resolution of respiratory symptoms, two consecutively negative results of sputum SARS-CoV-2 by RT-PCR assay (at least 24 hours apart) 22 to 35 days of post onset period, and neutralizing antibody titre ≥ 1:160.
INTERVENTION AND COMPARATOR


This RCT consists of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP. Patients will receive plasma as a single transfusion. Intervention arms will be compared to the standard care arm.
MAIN OUTCOMES


The primary outcome will be time to clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality. The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
RANDOMISATION


Randomization will be done by someone not associated with the care or assessment of the patients by means of a computer generated random number table using an allocation ratio of 1:1:1.
BLINDING (MASKING)


This is an open level study; neither the physician nor the patients will be blinded. However, the primary and secondary outcome (oxygen saturations, PaO2/FiO2, BP, day specific laboratory tests) will be recorded using an objective automated method; the study staff will not be able to influence the recording of these data.
NUMBER TO BE RANDOMISED (SAMPLE SIZE)


No similar study has been performed previously. Therefore no data are available that could be used to generate a sample size calculation. This phase II study is required to provide some initial data on efficacy and safety that will allow design of a larger study. The trial will recruit 60 participants (20 in each arm).
TRIAL STATUS


Protocol version 1.4 dated May 5, 2020 and amended version 1.5, dated June 16, 2020. First case was recruited on May 27, 2020. By August 10, 2020, the trial had recruited one-third (21 out of 60) of the participants. The recruitment is expected to finish by October 31, 2020.
TRIAL REGISTRATION


Clinicaltrials.gov ID: NCT04403477 . Registered 26 May, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trial's website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
","['Age and sex matched COVID-19 positive (by RT-PCR) severe cases', 'Patients will be enrolled at Bangabandhu Sheikh Mujib Medical University (BSMMU) hospital, Dhaka medical college hospital (DMCH) and Mugda medical college hospital (MuMCH', 'severe COVID-19 patients Specific', 'First case was recruited on May 27, 2020', 'General', '60 participants (20 in each arm', 'By August 10, 2020, the trial had recruited one-third (21 out of 60) of the participants', 'pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded', 'severe COVID-19 patients d', 'Patients who have recovered from COVID-19 will be recruited as donors of CP', 'Protocol version 1.4 dated May 5, 2020 and amended version 1.5, dated June 16, 2020', 'severe patients']","['convalescent plasma (CP) transfusion', 'CP therapy']","['Respiratory rate > 30 breaths/min', 'NUMBER', 'Systolic BP', 'safety, efficacy', 'improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support', 'oxygen saturations, PaO2/FiO2, BP, day specific laboratory tests', 'Severe respiratory distress', 'time to clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",60.0,0.180842,"The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
","[{'ForeName': 'Fazle Rabbi', 'Initials': 'FR', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Internal Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. rabbimedicine@bsmmu.edu.bd.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Hoque', 'Affiliation': 'Department of Blood Transfusion, Sheikh Hasina National Institute of Burn and Plastic Surgery (SHNIBPS), Dhaka, Bangladesh.'}, {'ForeName': 'Forhad Uddin Hasan', 'Initials': 'FUH', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Ruhul', 'Initials': 'MR', 'LastName': 'Amin', 'Affiliation': 'Centre for Medical Biotechnology, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Abdur', 'Initials': 'A', 'LastName': 'Rahim', 'Affiliation': 'Kuwait Bangladesh Friendship Government Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'M Mujibur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Yasmin', 'Affiliation': 'Department of Medicine, Mugda Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Robed', 'Initials': 'MR', 'LastName': 'Amin', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Titu', 'Initials': 'MT', 'LastName': 'Miah', 'Affiliation': 'Department of Medicine, Mugda Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Abul', 'Initials': 'MA', 'LastName': 'Kalam', 'Affiliation': 'Department of Blood Transfusion, Sheikh Hasina National Institute of Burn and Plastic Surgery (SHNIBPS), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sayedur', 'Initials': 'MS', 'LastName': 'Rahman', 'Affiliation': 'Department of Internal Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh.'}]",Trials,['10.1186/s13063-020-04734-z']
1732,33106168,"Correction to: Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['healthy adults'],['placebo'],[],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.092144,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'National University of Natural Medicine, Portland, USA. rbradley@nunm.edu.'}, {'ForeName': 'Blake O', 'Initials': 'BO', 'LastName': 'Langley', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phipps', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stack', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Jansson', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Metz', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Jan Frederik', 'Initials': 'JF', 'LastName': 'Stevens', 'Affiliation': 'Oregon State University, Corvallis, USA.'}]",Trials,['10.1186/s13063-020-04834-w']
1733,33106170,BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG.
TRIAL DESIGN


This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated.
PARTICIPANTS


The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test. Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial.
INTERVENTION AND COMPARATOR


HW will be randomized into the BCG vaccinated group or the BCG unvaccinated control group. The BCG vaccinated group will receive in the right arm, intradermally, a one off dose of 0.1 mL corresponding to approximately 2 x10 5  to 8 x10 5  CFU of live, freeze-dried, attenuated BCG Moscow 361-I, Bacillus Calmette Guerin vaccine (Serum Institute of India PVT. LTD.). The unvaccinated control group will not be vaccinated. The HW allocated in both groups will be followed up at specific times points until 180 days post inclusion. The vaccinated and control groups will be compared according to COVID-19 related outcomes.
MAIN OUTCOMES


The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up. The secondary outcome is the innate immune response elicited 15-20 days after vaccination.
RANDOMISATION


The vaccine vial contains approximately 10 doses. In order to optimize the vaccine use, the randomisation was performed in blocks of 20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ]. The randomization was prepared before any HW inclusion. The results were printed and inserted in sealed envelopes that were numbered with BCG-001 to BCG-400. The printed results as well the envelopes had the same numbers. At the time of the randomisation, each participant that meets the inclusion criteria will receive a consecutive participant number [BCG-001-BCG-400]. The sealed envelope with the assigned number, blinded to the researchers, will be opened in front of the participant and the arm allocation will be known.
BLINDING (MASKING)


There is no masking for the participants or for the healthcare providers. The study will be blinded to the laboratory researchers and to those who will be evaluating the outcomes and performing the statistical analyses. In this case, only the participant identification number will be available.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Four hundred heath workers will be randomised in two groups. Two hundred participants will be vaccinated, and 200 participants will not be vaccinated.
TRIAL STATUS


The protocol approved by the Brazilian Ethical Committee is the seventh version, number CAAE: 31783720.0.0000.5078. The trial has been recruiting since September 20 th , 2020. The clinical trial protocol was registered on August 5 th , 2020. It is estimated that recruitment will finish by March 2021.
TRIAL REGISTRATION


The protocol number was registered on August 5 th , 2020 at REBEC (Registro Brasileiro de Ensaios Clínicos). Register number: RBR-4kjqtg and WHO trial registration number UTN: U1111-1256-3892.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up.","['Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test', 'Register number', 'Four hundred heath workers', 'Two hundred participants will be vaccinated, and 200 participants will not be vaccinated', 'severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with', '20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ', 'Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial', '800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation']","['BCG Moscow', 'BCG', 'BCG vaccine', 'UTN']","['incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital', 'innate immune response elicited 15-20 days after vaccination', 'innate immune responses against COVID-19']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0335245', 'cui_str': 'Receptionist (general)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",200.0,0.269915,"The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up.","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Junqueira-Kipnis', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil. ana_kipnis@ufg.br.'}, {'ForeName': 'Laura Raniere Borges', 'Initials': 'LRB', 'LastName': 'Dos Anjos', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Lília Cristina de Souza', 'Initials': 'LCS', 'LastName': 'Barbosa', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Adeliane Castro', 'Initials': 'AC', 'LastName': 'da Costa', 'Affiliation': 'Faculdade Estácio de Sá de Goiás - FESGO, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Kellen Christina Malheiros', 'Initials': 'KCM', 'LastName': 'Borges', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Amanda da Rocha Oliveira', 'Initials': 'ADRO', 'LastName': 'Cardoso', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Kaio Mota', 'Initials': 'KM', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Sarah Brena Aparecida', 'Initials': 'SBA', 'LastName': 'Rosa', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Carine de Castro', 'Initials': 'CC', 'LastName': 'Souza', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Rogério Coutinho', 'Initials': 'RC', 'LastName': 'das Neves', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Guylherme', 'Initials': 'G', 'LastName': 'Saraiva', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Sueli Meira', 'Initials': 'SM', 'LastName': 'da Silva', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'da Silveira', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Marcelo Fouad', 'Initials': 'MF', 'LastName': 'Rabahi', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Marcus Barreto', 'Initials': 'MB', 'LastName': 'Conte', 'Affiliation': 'Centro Universitário Arthur Sá Earp Neto. - UNIFASE- Petrópolis, Rio de Janeiro, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kipnis', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}]",Trials,['10.1186/s13063-020-04822-0']
1734,33106171,Evaluation of the efficacy and safety of Melatonin in moderately ill patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderately ill.
TRIAL DESIGN


This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS


All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria.
INCLUSION CRITERIA


1. Age ≥20 years 2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction). 3. Moderate COVID-19 pneumonia (via computed tomography and or X-ray imaging), requiring hospitalization. 4. Hospitalized ≤48 hours. 5. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA


1. Underlying diseases, including chronic hypertension, diabetes mellitus, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs (during the last 30 days). 4. History of known allergy to Melatonin. 5. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR


Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules at a dose of 50 mg daily for a period of seven days.
CONTROL GROUP


The standard therapeutic regimen for COVID-19 along with Melatonin-like placebo capsules at a dose of one capsule daily for a period of seven days. Both Melatonin and placebo capsules were prepared at the Faculty of Pharmacy and Pharmaceutical Sciences, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
MAIN OUTCOMES


The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization. The secondary outcomes are the time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions within seven days of randomization.
RANDOMIZATION


Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
BLINDING (MASKING)


All study participants, clinicians, nurses, research coordinators, and those analyzing the data are blinded to the group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 60 patients randomized into two groups (30 in each group).
TRIAL STATUS


The trial protocol is Version 1.0, August 14, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by November 30, 2020.
TRIAL REGISTRATION


The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N5 "". The registration date was 14 August 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization.","['Age ≥20 years 2', 'Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria', '60 patients randomized into two groups (30 in each group', 'patients with confirmed COVID-19, who are moderately ill', 'moderately ill patients with COVID-19']","['Melatonin-like placebo', 'warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs', 'placebo', ""standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules"", 'Melatonin and placebo', 'Melatonin', 'GROUP']","['recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization', 'time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions', 'efficacy and safety', 'clinical symptoms and serum inflammatory parameters', 'Severe and critical COVID-19 pneumonia']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3653892', 'cui_str': 'Other antivirals'}, {'cui': 'C0260205', 'cui_str': 'Investigative Medicine'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",60.0,0.384965,"The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization.","[{'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Ziaei', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Masjedi', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Mahmoudikia', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04737-w']
1735,33106259,Clinical pharmacokinetics of fosfomycin after continuous infusion compared with intermittent infusion: a randomized crossover study in healthy volunteers.,"Objectives:  Continuous infusion (CON) of fosfomycin has been proposed as potentially advantageous in certain clinical scenarios. However, no clinical data on the pharmacokinetics (PK) of fosfomycin after CON are available to date. This study aimed at investigating the PK of fosfomycin after CON and compare it with intermittent infusion (INT) of fosfomycin. Methods:  A randomized two-way crossover study including 8 healthy male volunteers was performed. Each subject received fosfomycin as INT of 8g over 30 minutes every 8 hours and, separated by a wash-out period, as CON of 1g/hour preceded by a loading dose of 8g over 30 minutes. PK sampling was performed for 18 and 24 hours in the CON and INT group, respectively. Results:  Fosfomycin was generally well tolerated. However, 2 out of 8 subjects (25%) developed thrombophlebitis at the infusion site following CON, which was prevented in the following subjects with simultaneous co-infusion of Ringer's lactate. Steady-state C max  and AUC SS, 0-24  of fosfomycin after INT were 551.5 ± 67.8 mg/L and 3678.5 ± 601.9 h*mg/L, respectively. CON led to an average steady-state concentration of 183.8 ± 35.9 mg/L, resulting in a calculated AUC SS, 0-24  of 4411.2 ± 862.4 h*mg/L, which was 1.2-fold higher compared with INT. CON resulted in 100% T >MIC  for MICs ≤ 128 mg/L, whereas %T >MIC  for INT was only 44% for a MIC of 128 mg/L. Conclusions:  CON of fosfomycin led to improved PK and PK/PD determinants in plasma of healthy volunteers. The clinical relevance of these findings remains to be investigated in patients.",2020,MIC  for INT was only 44% for a MIC of 128 mg/L. Conclusions:  CON of fosfomycin led to improved PK and PK/PD determinants in plasma of healthy volunteers.,"['8 healthy male volunteers', 'healthy volunteers']","['Continuous infusion (CON) of fosfomycin', 'fosfomycin', 'CON', 'intermittent infusion (INT) of fosfomycin']","['tolerated', 'thrombophlebitis']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0040046', 'cui_str': 'Thrombophlebitis'}]",8.0,0.0555654,MIC  for INT was only 44% for a MIC of 128 mg/L. Conclusions:  CON of fosfomycin led to improved PK and PK/PD determinants in plasma of healthy volunteers.,"[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Al Jalali', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Matzneller', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Wulkersdorfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Scharon', 'Initials': 'S', 'LastName': 'Chou', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Bahmany', 'Affiliation': 'Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Birgit C P', 'Initials': 'BCP', 'LastName': 'Koch', 'Affiliation': 'Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria markus.zeitlinger@meduniwien.ac.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01375-20']
1736,33106278,"Effectiveness of onabotulinumtoxinA (BOTOX) in pediatric patients experiencing migraines: a randomized, double-blinded, placebo-controlled crossover study in the pediatric pain population.","INTRODUCTION


OnabotulinumtoxinA (OBTA) is approved for treating chronic headaches and migraines in adults, but there is limited scientific literature on the outcomes in pediatric patients. The aim of this study was to determine if subjects treated with OBTA reported a statistically significant improvement in the primary features (frequency, intensity, duration and disability scoring) associated with migraines compared with placebo at follow-up visits.
METHODS


After obtaining approval by the appropriate local (HS# 2016-3108) and federal institutions, the principal investigator enrolled candidates aged 8 to 17 years old diagnosed with chronic migraines (at least 6 months), and 15 or more headache days in a 4-week baseline period. This randomized control trial consisted of two phases: double-blind and open-label for the first two and last two sets of treatments, respectively. Subjects were randomly assigned to receive a treatment protocol-155 units at 31 injection sites-in 3-month intervals and follow-up visits every 6 weeks. Non-parametric testing (Wilcoxon signed-rank test) was performed using widely available open-source statistical software ('R').
RESULTS


From February 2017 to November 2018, 17 subjects presented for a screening visit; 15 met eligibility criteria. Subjects that received OBTA reported a statistically significant decrease from the following baseline values compared with placebo 6-week post-treatment compared with placebo: frequency (20 (7 to 17) vs 28 (23 to 28); p=0.038), intensity (5 (3 to 7) vs 7 (5 to 9); p=0.047), and PedMIDAS (Pediatric Migraine Disability Score) (3 (2 to 4) vs 4 (4 to 4); p=0.047). There was no statistically significant difference in the duration (10 (2 to 24) vs 24 (4 to 24); p=0.148) of migraines between the two groups.
DISCUSSION


OnabotulinumtoxinA showed a statistically significant decrease in frequency and intensity of migraines compared with placebo. No adverse effects or serious adverse events related to the use of OBTA were reported. In the future, we aim to evaluate the specific nature of migraines, for example, quality/location of pain presented during an initial consult to predict the likelihood of OBTA being a truly effective modality of pain management for pediatric migraineurs.
TRIAL REGISTRATION NUMBER


NCT03055767.",2020,No adverse effects or serious adverse events related to the use of OBTA were reported.,"['principal investigator enrolled candidates aged 8 to 17 years old diagnosed with chronic migraines (at least 6 months), and 15 or more headache days in a 4-week baseline period', 'pediatric pain population', 'pediatric patients', 'pediatric patients experiencing migraines', '17 subjects presented for a screening visit; 15 met eligibility criteria', 'pediatric migraineurs', 'From February 2017 to November 2018']","['placebo', 'OnabotulinumtoxinA (OBTA', 'onabotulinumtoxinA (BOTOX']","['frequency and intensity of migraines', 'primary features (frequency, intensity, duration and disability scoring', 'PedMIDAS (Pediatric Migraine Disability Score']","[{'cui': 'C1521895', 'cui_str': 'Principal investigator'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0700702', 'cui_str': 'Botox'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.267105,No adverse effects or serious adverse events related to the use of OBTA were reported.,"[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868 ssshah1@hs.uci.edu.'}, {'ForeName': 'Michael-David', 'Initials': 'MD', 'LastName': 'Calderon', 'Affiliation': 'Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Crain', 'Affiliation': 'Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pham', 'Affiliation': 'Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rinehart', 'Affiliation': 'Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101605']
1737,33106280,Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy.,"BACKGROUND


Robotic and hand-assisted laparoscopic nephrectomies are often associated with moderate to severe postoperative pain. The aim of the current study was to investigate the analgesic efficacy of the transmuscular quadratus lumborum (TQL) block for patients undergoing robotic or hand-assisted laparoscopic nephrectomy.
METHODS


Fifty patients were included in this single-center study. All patients were scheduled for elective hand-assisted or robotic laparoscopic nephrectomy under general anesthesia. Preoperatively, patients were randomly allocated to TQL block bilaterally with ropivacaine 60 mL 0.375% or 60 mL saline and all patients received standard multimodal analgesia and intravenous patient-controlled analgesia. Primary outcome was postoperative oral morphine equivalent (OME) consumption 0-12 hours. Secondary outcomes were postoperative OME consumption up to 24 hours, pain scores, time to first opioid, nausea/vomiting, time to first ambulation and hospital length of stay (LOS).
RESULTS


Mean (95% CI) OME consumption was significantly lower in the intervention group at 12 hours after surgery 50 (28.5 to 71.5) mg versus control 87.5 (62.7 to 112.3) mg, p=0.02. At 24 hours, 69.4 (43.2 to 95.5) mg versus 127 (96.7 to 158.6) mg, p<0.01. Time to first opioid was significantly prolonged in the intervention group median (IQR) 4.4 (2.8-17.6) hours compared with 0.3 (0.1-1.0) hours in the control group, p<0.001. No significant intergroup differences were recorded for time to first ambulation, pain scores, nausea/vomiting nor for LOS.
CONCLUSION


Preoperative bilateral TQL block significantly reduced postoperative opioid consumption by 43% and significantly prolonged time to first opioid.
TRIAL REGISTRATION NUMBER


NCT03571490.",2020,"No significant intergroup differences were recorded for time to first ambulation, pain scores, nausea/vomiting nor for LOS.
","['Fifty patients were included in this single-center study', 'All patients were scheduled for elective hand-assisted or', 'patients undergoing robotic or hand-assisted laparoscopic nephrectomy']","['laparoscopic nephrectomy', 'Robotic and hand-assisted laparoscopic nephrectomies', 'robotic laparoscopic nephrectomy under general anesthesia', 'TQL block bilaterally with ropivacaine 60\u2009mL 0.375% or 60\u2009mL saline', 'standard multimodal analgesia and intravenous patient-controlled analgesia', 'transmuscular quadratus lumborum (TQL) block']","['Mean', 'postoperative oral morphine equivalent (OME) consumption 0-12\u2009hours', 'analgesic efficacy', 'postoperative opioid consumption', 'OME consumption', 'Time to first opioid', 'postoperative OME consumption up to 24\u2009hours, pain scores, time to first opioid, nausea/vomiting, time to first ambulation and hospital length of stay (LOS', 'time to first ambulation, pain scores, nausea/vomiting nor for LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",50.0,0.220326,"No significant intergroup differences were recorded for time to first ambulation, pain scores, nausea/vomiting nor for LOS.
","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Dam', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Troels Dirch', 'Initials': 'TD', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Nessn Htum', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Gunnar Hellmund', 'Initials': 'GH', 'LastName': 'Laier', 'Affiliation': 'Nørresundby, Denmark.'}, {'ForeName': 'Morné', 'Initials': 'M', 'LastName': 'Wolmarans', 'Affiliation': 'Anaesthesiology, Norfolk and Norwich University Hospital NHS Trust, Norwich, Norfolk, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Anesthesia, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Thomas Fichtner', 'Initials': 'TF', 'LastName': 'Bendtsen', 'Affiliation': 'Anesthesiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Børglum', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark jens.borglum@gmail.com.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101745']
1738,33106286,Brodalumab in psoriatic arthritis: results from the randomised phase III AMVISION-1 and AMVISION-2 trials.,"OBJECTIVE


To compare the efficacy and safety of brodalumab, an interleukin-17 receptor subunit A inhibitor, with placebo, in patients with psoriatic arthritis (PsA).
METHODS


Adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment were enrolled into two phase III studies (NCT02029495 and NCT02024646) and randomised 1:1:1 to receive subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks. About 30% of patients had prior use of biologics. The primary endpoint for both studies was the American College of Rheumatology 20 (ACR20) response at week 16.
RESULTS


962 patients were randomised across the studies prior to early termination due to sponsor decision. The primary endpoint was met in both studies. Based on comparable design and eligibility criteria, data from both studies were pooled. Significantly more patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140 mg and 210 mg, respectively) versus placebo (20.9%) (p<0.0001). Similar results were observed at week 24. Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01). Adverse event rates were similar across treatments at week 16 (54.4%, 51.6% and 54.5% for placebo, brodalumab 140 mg and 210 mg, respectively). No new safety signals were reported.
CONCLUSION


Brodalumab was associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. Brodalumab was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors.",2020,"Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01).","['962 patients', 'Adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment', 'patients with psoriatic arthritis (PsA', 'psoriatic arthritis']","['placebo', 'brodalumab', 'subcutaneous brodalumab 140\u2009mg or 210\u2009mg or placebo']","['Adverse event rates', 'American College of Rheumatology 20', 'ACR20', 'ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}]",962.0,0.345218,"Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01).","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Rheumatology Research, Swedish Medical Center, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Academic Unit of Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kasper Fjellhaugen', 'Initials': 'KF', 'LastName': 'Hjuler', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Raymond', 'Affiliation': 'Medical Department, Leo Pharma, Ballerup, Denmark.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216835']
1739,33106609,Intensive treat-to-target statin therapy and severity of diabetic retinopathy complicated by hypercholesterolaemia.,"OBJECTIVES


To compare the effects of intensive and standard statin therapy on severity of diabetic retinopathy (DR) complicated by hypercholesterolaemia in a prespecified substudy of the standard vs. intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study.
METHODS


Among 5144 patients in the multicentre, prospective, randomized EMPATHY study, this substudy considered 157 patients with seven-field fundus photographs of sufficient quality taken during study enrolment and at the 3-year visit. Eighty-five and seventy-two patients received intensive and standard statin treatments, respectively, in a treat-to-target manner. The primary endpoint was a two-step change in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR severity scale at 36 months. Surrogate markers included changes in hard exudates, changes in visual acuity, and additional ocular treatments during study follow-up.
RESULTS


Intensive and standard treatment groups did not differ significantly in terms of changing two or more steps on the DR severity scale (P = 0.4380). In patients with severe DR, defined as ≥47 on the severity scale, exploratory analysis showed more frequent improvement of DR, by at least one step, with intensive vs. standard treatment (83.3% vs. 40.0%; P = 0.0346). The intensive and standard groups did not differ in changes on the hard exudates severity scale (P = 0.3460), logarithm of minimum angle of resolution visual acuity (P = 0.5500), or additional ocular treatment during follow-up.
CONCLUSIONS


Intensive and standard statin treatment may have similar effects on DR in the population of all patients with DR and hypercholesterolaemia, but intensive therapy may be more beneficial in patients with severe DR.",2020,"The intensive and standard groups did not differ in changes on the hard exudates severity scale (P = 0.3460), logarithm of minimum angle of resolution visual acuity (P = 0.5500), or additional ocular treatment during follow-up.
","['Eighty-five and seventy-two patients received', 'hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study', 'diabetic retinopathy complicated by hypercholesterolaemia', 'patients with severe DR', '157 patients with seven-field fundus photographs of sufficient quality taken during study enrolment and at the 3-year visit', '5144 patients']","['Intensive treat-to-target statin therapy', 'intensive and standard statin therapy', 'intensive and standard statin']","['logarithm of minimum angle of resolution visual acuity', 'hard exudates severity scale', 'DR severity scale', 'severity of diabetic retinopathy (DR', 'two-step change in the Early Treatment Diabetic Retinopathy Study (ETDRS']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0423410', 'cui_str': 'Retinal lipid deposits'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",157.0,0.0390123,"The intensive and standard groups did not differ in changes on the hard exudates severity scale (P = 0.3460), logarithm of minimum angle of resolution visual acuity (P = 0.5500), or additional ocular treatment during follow-up.
","[{'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Department of Ophthalmology, Kyoto University Graduate School of Medicine, Kyoto, Japan. mutomo@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigeeda', 'Affiliation': 'Ideta Eye Clinic, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan.'}, {'ForeName': 'Nagahisa', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Eye (London, England)",['10.1038/s41433-020-01202-5']
1740,33106629,Evidence against benefits from cognitive training and transcranial direct current stimulation in healthy older adults.,"Cognitive training and brain stimulation show promise for ameliorating age-related neurocognitive decline. However, evidence for this is controversial. In a Registered Report, we investigated the effects of these interventions, where 133 older adults were allocated to four groups (left prefrontal cortex anodal transcranial direct current stimulation (tDCS) with decision-making training, and three control groups) and trained over 5 days. They completed a task/questionnaire battery pre- and post-training, and at 1- and 3-month follow-ups. COMT and BDNF Val/Met polymorphisms were also assessed. Contrary to work in younger adults, there was evidence against tDCS-induced training enhancement on the decision-making task. Moreover, there was evidence against transfer of training gains to untrained tasks or everyday function measures at any post-intervention time points. As indicated by exploratory work, individual differences may have influenced outcomes. But, overall, the current decision-making training and tDCS protocol appears unlikely to lead to benefits for older adults.",2020,"Contrary to work in younger adults, there was evidence against tDCS-induced training enhancement on the decision-making task.","['133 older adults', 'younger adults', 'older adults', 'healthy older adults']","['Cognitive training and brain stimulation', 'cognitive training and transcranial direct current stimulation', 'prefrontal cortex anodal transcranial direct current stimulation (tDCS) with decision-making training, and three control groups) and trained over 5 days']",[],"[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0543432', 'cui_str': 'Problem solving training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],133.0,0.0306847,"Contrary to work in younger adults, there was evidence against tDCS-induced training enhancement on the decision-making task.","[{'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Horne', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia. k.horne@uq.edu.au.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Filmer', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Zoie E', 'Initials': 'ZE', 'LastName': 'Nott', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ziarih', 'Initials': 'Z', 'LastName': 'Hawi', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kealan', 'Initials': 'K', 'LastName': 'Pugsley', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Mattingley', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Dux', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}]",Nature human behaviour,['10.1038/s41562-020-00979-5']
1741,33106665,Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial.,"Acute myeloid leukemia (AML) is the most common diagnosed leukemia. In older adults, AML confers an adverse outcome 1,2 . AML originates from a dominant mutation, then acquires collaborative transformative mutations leading to myeloid transformation and clinical/biological heterogeneity. Currently, AML treatment is initiated rapidly, precluding the ability to consider the mutational profile of a patient's leukemia for treatment decisions. Untreated patients with AML ≥ 60 years were prospectively enrolled on the ongoing Beat AML trial (ClinicalTrials.gov NCT03013998), which aims to provide cytogenetic and mutational data within 7 days (d) from sample receipt and before treatment selection, followed by treatment assignment to a sub-study based on the dominant clone. A total of 487 patients with suspected AML were enrolled; 395 were eligible. Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7 d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study. The remaining 171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment. Demographic, laboratory and molecular characteristics were not significantly different between patients on the Beat AML sub-studies and those receiving SOC (induction with cytarabine + daunorubicin (7 + 3 or equivalent) or hypomethylation agent). Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC. A precision medicine therapy strategy in AML is feasible within 7 d, allowing patients and physicians to rapidly incorporate genomic data into treatment decisions without increasing early death or adversely impacting overall survival.",2020,Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC.,"['acute myeloid leukemia', 'Untreated patients with AML\u2009≥\u200960 years', '487 patients with suspected AML were enrolled; 395 were eligible', 'Acute myeloid leukemia (AML', 'Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7\u2009d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study', '171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment']","['cytarabine\u2009+\u2009daunorubicin', 'Precision medicine treatment']","['Demographic, laboratory and molecular characteristics', 'overall survival']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0752095', 'cui_str': 'Cytogenetic analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0949266', 'cui_str': 'Investigational Therapies'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2718059', 'cui_str': 'P Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",487.0,0.168831,Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Burd', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Levine', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Mims', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Borate', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Eytan M', 'Initials': 'EM', 'LastName': 'Stein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Prapti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Baer', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Deininger', 'Affiliation': 'The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blum', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Schiller', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Olin', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litzow', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Foran', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ball', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyiadzis', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Traer', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Olatoyosi', 'Initials': 'O', 'LastName': 'Odenike', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Arellano', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Duong', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Kovacsovics', 'Affiliation': 'The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Foster', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Vergilio', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brennan', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vietz', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Severson', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Marcus', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Yocum', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stefanos', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Druker', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University, Columbus, OH, USA. John.Byrd@osumc.edu.'}]",Nature medicine,['10.1038/s41591-020-1089-8']
1742,33106696,Comprehensive Prospective Analysis of the Factors Contributing to Aspiration Pneumonia Following Endoscopic Submucosal Dissection in Patients with Early Gastric Neoplasms.,"Endoscopic submucosal dissection (ESD) has become the first-line treatment for early gastric neoplasms; however, a subset of patients treated by this method develop aspiration pneumonia. We conducted a comprehensive prospective analysis of the factors contributing to post-ESD aspiration pneumonia in early gastric neoplasms in this study, with special focus on whether pre-treatment oral care can prevent aspiration pneumonia. Sixty-one patients who underwent ESD for gastric neoplasms were randomly assigned to the oral care or control groups. ESD was performed under deep sedation. Of 60 patients whose data were available for analysis, 5 (8.3%) experienced pneumonia confirmed either by chest radiography or computed tomography. Although no difference in the rate of pneumonia was found between the control and oral care groups, the post-oral care bacteria count was significantly higher in the saliva of patients who developed pneumonia compared to those without pneumonia. In addition, the presence of vascular brain diseases and the dose of meperidine were also significantly associated with the occurrence of pneumonia. These results suggest that the number of oral bacteria as well as pre-existing vascular brain diseases and high-dose narcotics can affect the incidence of post-ESD pneumonia.",2020,"Although no difference in the rate of pneumonia was found between the control and oral care groups, the post-oral care bacteria count was significantly higher in the saliva of patients who developed pneumonia compared to those without pneumonia.","['Sixty-one patients who underwent ESD for gastric neoplasms', 'Patients with Early Gastric Neoplasms', '60 patients whose data were available for analysis, 5 (8.3%) experienced pneumonia confirmed either by chest radiography or computed tomography']","['meperidine', 'Endoscopic Submucosal Dissection', 'Endoscopic submucosal dissection (ESD']","['post-oral care bacteria count', 'occurrence of pneumonia', 'rate of pneumonia']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",61.0,0.0151444,"Although no difference in the rate of pneumonia was found between the control and oral care groups, the post-oral care bacteria count was significantly higher in the saliva of patients who developed pneumonia compared to those without pneumonia.","[{'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Togo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Akazawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Akashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Yamashita', 'Affiliation': 'Oral Care Center, Nagasaki University Hospital, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Yoshitomi', 'Affiliation': 'JCHO Isahaya General Hospital, Isahaya, Nagasaki 854-8501, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Ohba', 'Affiliation': 'JCHO Isahaya General Hospital, Isahaya, Nagasaki 854-8501, Japan.'}, {'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'JCHO Isahaya General Hospital, Isahaya, Nagasaki 854-8501, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Iwashita', 'Affiliation': 'JCHO Isahaya General Hospital, Isahaya, Nagasaki 854-8501, Japan.'}, {'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kurogi', 'Affiliation': 'Oral Care Center, Nagasaki University Hospital, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Osada', 'Affiliation': ""Dental Hygienist's Office, Department of Medical Technology, Nagasaki University Hospital, Nagasaki 852-8501, Japan.""}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Wada', 'Affiliation': ""Dental Hygienist's Office, Department of Medical Technology, Nagasaki University Hospital, Nagasaki 852-8501, Japan.""}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Hisayoshi', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Biostatistics Section, Division of Scientific Data Registry, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Medicine, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.'}]",Acta medica Okayama,['10.18926/AMO/60800']
1743,33106755,Learning to breathe with Tai Chi online - qualitative data from a randomized controlled feasibility study of patients with cystic fibrosis.,"INTRODUCTION


Tai Chi (TC), a gentle exercise, incorporates meditative movement and respiratory control. The high risk of cross infection for people with cystic fibrosis (CF) requires close management in healthcare settings, limiting group activities such as TC. A mixed-methods randomized controlled feasibility study compared teaching TC over the internet with in-person, face to face TC tuition provided to CF patients. This article explores qualitative data from patients and TC instructors on their attitudes, acceptability and engagement with the two modes of TC delivery.
METHODS


Qualitative data from CF patients (>6 years) were collected using Skype interviews/focus groups and written feedback. TC instructors provided weekly written feedback, and took part in interviews/ focus groups at the end of the study. Patients and instructors interviews explored their experiences and engagement with TC online delivery and ability to practice.
RESULTS


Irrespective of the type of TC delivery, all CF participants interviewed (n=28) practiced between lessons and most wanted to continue TC. Teenagers were more likely to miss TC appointments. Internet delivery was well received by both patients and TC instructors. Two patients reported difficulties with screen size/camera and one with internet connectivity.
CONCLUSION


Both face-to-face and internet delivery of Tai Chi lessons were equally well received and perceived as beneficial. In the current COVID-19 pandemic, CF patients self-isolating may find this intervention provides important support, therefore the programme was made available on YouTube in April 2020 and linked to the websites of the CF charities funding the research.",2020,"Irrespective of the type of TC delivery, all CF participants interviewed (n=28) practiced between lessons and most wanted to continue TC.","['people with cystic fibrosis (CF', 'Qualitative data from CF patients (>6 years', 'patients with cystic fibrosis']","['teaching TC', 'Tai Chi (TC']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}]",[],,0.0211587,"Irrespective of the type of TC delivery, all CF participants interviewed (n=28) practiced between lessons and most wanted to continue TC.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ronan', 'Affiliation': 'Allied Health Sciences, School of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA.'}, {'ForeName': 'Awais', 'Initials': 'A', 'LastName': 'Mian', 'Affiliation': 'Allied Health Sciences, School of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA.'}, {'ForeName': 'Siobhán B', 'Initials': 'SB', 'LastName': 'Carr', 'Affiliation': 'Department of Paediatric Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, Sydney Street, London, SW3 6NP.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Madge', 'Affiliation': 'Adult Cystic Fibrosis Department, Royal Brompton and Harefield NHS Foundation Trust, London, Sydney Street, London, SW3 6NP.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Lorenc', 'Affiliation': 'Population Health Sciences Department, University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU.'}, {'ForeName': 'Professor Nicola', 'Initials': 'PN', 'LastName': 'Robinson', 'Affiliation': 'Allied Health Sciences, School of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA.'}]",European journal of integrative medicine,['10.1016/j.eujim.2020.101229']
1744,33106970,Potential of dosage reduction of cone-beam CT dacryocystography in healthy volunteers by decreasing tube current.,"PURPOSE


Cone-beam CT dacryocystography (CBCT-DCG) is a newly developed lacrimal passage imaging technique. This pilot study aimed to determine the effect of reducing tube current on image quality and radiation dose of CBCT-DCG in healthy volunteers.
MATERIALS AND METHODS


Thirty volunteers were randomly divided into three groups of ten. Each group of subjects underwent CBCT-DCG using a tube current of 13 mA, 10 mA, and 7 mA respectively. The image quality of CBCT-DCG was assessed independently by two observers using three different scoring methods and compared among the groups. The effective dose was estimated and compared among the three different tube current groups.
RESULTS


The CBCT-DCG images provided a high spatial and contrast resolution of the bony structures and the contrast medium. No significant differences were found in the image quality between different tube current groups. Compared with the 13 mA group (49.44 μSv), the effective dose for 10 mA group (38.40 μSv) and 7 mA group (27.12 μSv) decreased by 22.33% and 45.15%, respectively.
CONCLUSION


By decreasing the tube current, CBCT-DCG can be performed with a significant reduction of effective dose without loss of image quality in healthy volunteers.",2020,No significant differences were found in the image quality between different tube current groups.,"['healthy volunteers', 'Thirty volunteers', 'healthy volunteers by decreasing tube current']","['cone-beam CT dacryocystography', 'Cone-beam CT dacryocystography (CBCT-DCG', 'CBCT-DCG']","['tube current', 'image quality of CBCT-DCG', 'image quality']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0202744', 'cui_str': 'Dacryocystography'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",30.0,0.0144147,No significant differences were found in the image quality between different tube current groups.,"[{'ForeName': 'Zhaoyue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Xiamen Branch, Zhongshan Hospital, Fudan University, No. 668 JinHu Road, Xiamen, China. chen.zhaoyue@zsxmhospital.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology, Xiamen Branch, Zhongshan Hospital, Fudan University, No. 668 JinHu Road, Xiamen, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Xiamen Siming District Kaiyuan Street Community Health Service Center, Xiamen, China.'}]",Japanese journal of radiology,['10.1007/s11604-020-01058-5']
1745,33106976,Couple-based communication intervention for head and neck cancer: a randomized pilot trial.,"OBJECTIVE


To test feasibility and preliminary efficacy of a couple-based supportive communication (CSC) intervention for head and neck cancer (HNC) delivered during patients' oncology treatment.
METHODS


Twenty couples were randomly assigned to either a four-session CSC or a treatment-as-usual (TAU) condition. The CSC intervention primarily focused on increasing couple emotional disclosure, supportive listening, and social support. Patients and partners completed measures of individual and relationship functioning at baseline, post-intervention, and 6-month follow-up.
RESULTS


Ninety-eight percent of CSC sessions were completed and couples reported high levels of satisfaction with the intervention. Between-group effect sizes indicated that patients and partners in CSC reported improvements in individual and relationship functioning, relative to those in the TAU condition.
CONCLUSIONS


A couple-based communication intervention delivered during oncology treatment is feasible and acceptable in the context of HNC and may lead to improvements in individual and relationship functioning. Preliminary efficacy results are interpreted in the context of social-cognitive processing and intimacy theories.
TRIAL REGISTRATION


The trial was registered on www.clinicaltrials.gov (NCT01785576) first posted on February 7, 2013.",2020,"Between-group effect sizes indicated that patients and partners in CSC reported improvements in individual and relationship functioning, relative to those in the TAU condition.
","[""head and neck cancer (HNC) delivered during patients' oncology treatment"", 'Twenty couples', 'head and neck cancer']","['Couple-based communication intervention', 'couple-based supportive communication (CSC) intervention']","['couple emotional disclosure, supportive listening, and social support']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",20.0,0.0743297,"Between-group effect sizes indicated that patients and partners in CSC reported improvements in individual and relationship functioning, relative to those in the TAU condition.
","[{'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA. tina.gremore@duke.edu.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Brockstein', 'Affiliation': 'NorthShore University HealthSystem, Evanston, IL, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brenner', 'Affiliation': 'NorthShore University HealthSystem, Evanston, IL, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'NorthShore University HealthSystem, Evanston, IL, USA.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Tamara Golden', 'Initials': 'TG', 'LastName': 'Sher', 'Affiliation': 'Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Atkins', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05848-5']
1746,33107002,The Gears of Knowledge Translation: Process Evaluation of the Dissemination and Implementation of a Patient Engagement Toolkit.,"BACKGROUND


Patient engagement is a key tenet of patient-centered care and is associated with many positive health outcomes. To improve resources for patient engagement, we created a web-based, interactive patient engagement toolkit to improve patient engagement in primary care across the Veterans Health Administration (VHA).
OBJECTIVE


To use the knowledge translation (KT) framework to evaluate the dissemination and implementation of a patient engagement toolkit at facilities across one region in the VHA.
DESIGN


Using a mixed-methods approach, this process evaluation involved phone monitoring via semi-structured interviews and group meetings, during which we explored barriers and facilitators to KT. Outcomes were assessed using a structured rubric and existing patient satisfaction measures.
PARTICIPANTS


We enlisted implementers at 40 VHA facilities primarily serving Pennsylvania, New Jersey, and Delaware to implement patient engagement practices at their sites. Sites were randomly assigned into a high or low coaching group to assess whether external support influenced implementation.
KEY RESULTS


Sites with high rubric scores employed and possessed several elements across the KT trajectory from identification of the problem to sustainment of knowledge use. Key factors for successful implementation and dissemination included implementer engagement, organizational support, and strong collaborators. The most frequently cited barriers included short staffing, time availability, lack of buy-in, and issues with leadership. Successful implementers experienced just as many barriers, but leveraged facilitators to overcome obstacles. While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
CONCLUSIONS


Because leveraging available resources is a key component of successful implementation, future toolkits should highlight the type of facilitators necessary for successful implementation of toolkit content in healthcare settings. The ability to tailor interventions to local context is critical for overcoming barriers faced in most healthcare settings.",2020,"While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
","['We enlisted implementers at 40 VHA facilities primarily serving Pennsylvania, New Jersey, and Delaware to implement patient engagement practices at their sites']",['low coaching group to assess whether external support influenced implementation'],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0746443,"While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
","[{'ForeName': 'Shimrit', 'Initials': 'S', 'LastName': 'Keddem', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. shimrit.keddem@va.gov.'}, {'ForeName': 'Aneeza Z', 'Initials': 'AZ', 'LastName': 'Agha', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Shasha', 'Affiliation': 'Jhpiego Corporation, an affiliate of Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leslie R M', 'Initials': 'LRM', 'LastName': 'Hausmann', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, VA Center for Health Equity Research and Promotion (CHERP), Pittsburgh, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06099-0']
1747,33107110,Adiposity is associated with anovulation independent of serum free testosterone: A prospective cohort study.,"BACKGROUND


Obesity, a body mass index (BMI) ≥30 kg/m 2  , is linked to infertility, potentially through a greater risk of anovulation due to elevated androgens. Yet, previous studies have not directly assessed the impact of adiposity, or body fat, on anovulation in the absence of clinical infertility.
OBJECTIVE


To characterise the associations between adiposity and anovulation among women menstruating on a regular basis.
METHODS


Women from the EAGeR trial (n = 1200), a randomised controlled trial of low-dose aspirin and pregnancy loss among women trying to conceive, were used to estimate associations between adiposity and incident anovulation. Participants completed baseline questionnaires and anthropometry, and provided blood specimens. Women used fertility monitors for up to six consecutive menstrual cycles, with collection of daily first morning voids for hormone analysis in the first two menstrual cycles for prospective assessment of anovulation. Anovulation was assessed by urine pregnanediol glucuronide or luteinising hormone concentration or the fertility monitor. Weighted mixed-effects log-binomial regression was used to estimate associations between measures of adiposity and incident anovulation, adjusted for free (bioavailable) testosterone, anti-Mullerian hormone (AMH), serum lipids, and demographic and life style factors.
RESULTS


343 (28.3%) women experienced at least one anovulatory cycle. Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
CONCLUSIONS


Adiposity may be associated with anovulation through pathways other than testosterone among regularly menstruating women. This may account in part for reported associations between greater adiposity and infertility among women having menstrual cycles regularly. Understanding the association between adiposity and anovulation might lead to targeted interventions for preventing infertility.",2020,"Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
","['343 (28.3%) women experienced at least one anovulatory cycle', 'Women from the EAGeR trial (n\xa0', 'regularly menstruating women', 'women menstruating on a regular basis']",['aspirin'],"['serum free testosterone, AMH, lipids, and other factors', 'cm waist circumference', 'Anovulation', 'adiposity and incident anovulation, adjusted for free (bioavailable) testosterone, anti-Mullerian hormone (AMH), serum lipids, and demographic and life style factors', 'adiposity and anovulation', 'Adiposity', 'Anovulation risk', 'mm subscapular skinfold']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0558083', 'cui_str': 'Enthusiastic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0066928', 'cui_str': 'Mullerian regression factor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.186672,"Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bloom', 'Affiliation': 'Departments of Environmental Health Sciences and Epidemiology and Biostatistics, University at Albany, State University of New York, Rensselaer, NY, USA.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Kuhr', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Connell', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}]",Paediatric and perinatal epidemiology,['10.1111/ppe.12726']
1748,33107132,Phase 1 trial for treatment of COVID-19 patients with pulmonary fibrosis using hESC-IMRCs.,,2020,,['COVID-19 patients with pulmonary fibrosis using hESC-IMRCs'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}]",[],[],,0.0164588,,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tianda', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Baojie', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xianguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Baoyang', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}]",Cell proliferation,['10.1111/cpr.12944']
1749,33112472,Assessing the impact of First Episode Rapid Early Intervention for Eating Disorders on duration of untreated eating disorder: A multi-centre quasi-experimental study.,"BACKGROUND


Duration of untreated eating disorder (DUED), that is, the time between illness onset and start of first evidence-based treatment, is a key outcome for early intervention. Internationally, reported DUED ranges from 2.5 to 6 years for different eating disorders (EDs). To shorten DUED, we developed FREED (First Episode Rapid Early Intervention for EDs), a service model and care pathway for emerging adults with EDs. Here, we assess the impact of FREED on DUED in a multi-centre study using a quasi-experimental design.
METHODS


Two hundred and seventy-eight patients aged 16-25, with first episode illness of less than 3 years duration, were recruited from specialist ED services and offered treatment via FREED. These were compared to 224 patients, of similar age and illness duration, seen previously in participating services (treatment as usual [TAU]) on DUED, waiting times and treatment uptake.
RESULTS


FREED patients had significantly shorter DUED and waiting times than TAU patients. On average, DUED was reduced by ∼4 months when systemic delays were minimal. Furthermore, 97.8% of FREED patients took up treatment, versus 75.4% of TAU.
DISCUSSION


Findings indicate that FREED significantly improves access to treatment for emerging adults with first episode ED. FREED may reduce distress, prevent deterioration and facilitate recovery.",2020,"RESULTS


FREED patients had significantly shorter DUED and waiting times than TAU patients.","['Two hundred and seventy-eight patients aged 16-25, with first episode illness of less than 3 years duration, were recruited from specialist ED services and offered treatment via FREED', '224 patients, of similar age and illness duration, seen previously in participating services (treatment as usual [TAU]) on DUED, waiting times and treatment uptake', 'Eating Disorders on duration of untreated eating disorder']","['First Episode Rapid Early Intervention', 'FREED']",['DUED and waiting times'],"[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",278.0,0.0503254,"RESULTS


FREED patients had significantly shorter DUED and waiting times than TAU patients.","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Lang', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Ranjeet', 'Initials': 'R', 'LastName': 'Bassi', 'Affiliation': 'Eating Disorders Outpatient Service, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brady', 'Affiliation': 'Vincent Square Eating Disorder Service, Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Eating Disorders Outpatient Service, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Connan', 'Affiliation': 'Vincent Square Eating Disorder Service, Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Franklin-Smith', 'Affiliation': 'Eating Disorder Service, Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Glennon', 'Affiliation': 'Eating Disorders Outpatient Service, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Grant', 'Affiliation': 'Eating Disorders Outpatient Service, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'William Rhys', 'Initials': 'WR', 'LastName': 'Jones', 'Affiliation': 'Eating Disorder Service, Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Kali', 'Affiliation': 'Vincent Square Eating Disorder Service, Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Koskina', 'Affiliation': 'Eating Disorders Outpatient Service, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mahony', 'Affiliation': 'Eating Disorder Service, North East London NHS Foundation Trust, Rainham, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mountford', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'Vincent Square Eating Disorder Service, Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Schelhase', 'Affiliation': 'Eating Disorder Service, Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Serpell', 'Affiliation': 'Eating Disorder Service, North East London NHS Foundation Trust, Rainham, UK.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2797']
1750,33112480,"Endobronchial ultrasound guided transbronchialcryobiopsy in peripheral lung lesions; efficacy, safety, and comparison with transbronchial forceps biopsy.","INTRODUCTION


Radial probe endobronchial ultrasound (RP-EBUS) is a modern technique for diagnosis of peripheral lung lesions. It is assumed that the addition of transbronchial cryobiopsy (TBCB) could increase the diagnostic value for RP-EBUS.
OBJECTIVES


The main objectives were to evaluate the efficacy and safety of RP-EBUS guided TBCB for diagnosis of peripheral lung lesions and comparing it with RP-EBUS guided transbronchial forceps biopsy.
METHODS


60 patients with peripheral lung diseases were divided into two groups. Group I included 45 patients who were eligible for TBCB and they subjected to forceps transbronchial biopsy (forceps TBB) and TBCB guided by RP-EBUS. 15 patients who were not eligible for TBCB were included in group II and they were subjected to forceps TBB and / or cytology retrieval procedures guided by RP-EBUS.
RESULTS


In group I, forceps TBB had sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of; 67.5%, 100%, 100%, 18.8% and 69.8% respectively, while TBCB had sensitivity, specificity, PPV, NPV and accuracy of 75%, 100%, 100%, 23.1%, 76.7% respectively. The sensitivity in group II was 80% and the overall results including both groups were sensitivity, specificity, PPV, NPV and accuracy of 85.2%, 100%, 100%, 42.8% and 86.7% respectively. Regarding the complications, only one patient (1.7%) had significant bleeding. One patient (1.7%) had pneumothorax and another patient (1.7%) suffered from hypoxemia.
CONCLUSIONS


RP-EBUS guided TBCB is a safe and effective technique for diagnosis of peripheral lung lesions. TBCB has achieved higher diagnostic values and better quality of samples.",2020,"In group I, forceps TBB had sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of; 67.5%, 100%, 100%, 18.8% and 69.8% respectively, while TBCB had sensitivity, specificity, PPV, NPV and accuracy of 75%, 100%, 100%, 23.1%, 76.7% respectively.","['60 patients with peripheral lung diseases', '45 patients who were eligible for TBCB and they subjected to', 'peripheral lung lesions', '15 patients who were not eligible for TBCB']","['RP-EBUS guided TBCB', 'Endobronchial ultrasound guided transbronchialcryobiopsy', 'Radial probe endobronchial ultrasound (RP-EBUS', 'forceps TBB and / or cytology retrieval procedures guided by RP-EBUS', 'TBCB', 'transbronchial cryobiopsy (TBCB', 'forceps transbronchial biopsy (forceps TBB) and TBCB guided by RP-EBUS', 'transbronchial forceps biopsy']","['sensitivity, specificity, PPV, NPV and accuracy', 'sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy', 'significant bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0180936', 'cui_str': 'Biopsy forceps'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",60.0,0.0236016,"In group I, forceps TBB had sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of; 67.5%, 100%, 100%, 18.8% and 69.8% respectively, while TBCB had sensitivity, specificity, PPV, NPV and accuracy of 75%, 100%, 100%, 23.1%, 76.7% respectively.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Torky', 'Affiliation': 'Tanta University, Chest Department, Egypt.'}, {'ForeName': 'Wafaa S', 'Initials': 'WS', 'LastName': 'Elshimy', 'Affiliation': 'Tanta University, Chest Department, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelwahab', 'Affiliation': 'Tanta University, Chest Department, Egypt.'}, {'ForeName': 'Ghada A', 'Initials': 'GA', 'LastName': 'Attia', 'Affiliation': 'Tanta University, Chest Department, Egypt.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Lopez', 'Affiliation': 'Pathology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Mate', 'Affiliation': 'Facultat de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Centeno', 'Affiliation': 'Bronchoscopy Unit, Pulmonology Department, Hospital Universitari Germans Trias I Pujol, Badalona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Serra', 'Affiliation': 'Bronchoscopy Unit, Pulmonology Department, Hospital Universitari Germans Trias I Pujol, Badalona, Spain.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Tazi Mezalek', 'Affiliation': 'Bronchoscopy Unit, Pulmonology Department, Hospital Universitari Germans Trias I Pujol, Badalona, Spain.'}, {'ForeName': 'Eli Nancy', 'Initials': 'EN', 'LastName': 'Pérez', 'Affiliation': 'Pulmonology Department, Hospital Dos de Maig, Barcelona, Spain.'}, {'ForeName': 'Juan Ruiz', 'Initials': 'JR', 'LastName': 'Manzano', 'Affiliation': 'Facultat de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Andreo', 'Affiliation': 'Facultat de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rosell', 'Affiliation': 'Facultat de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.'}]",The clinical respiratory journal,['10.1111/crj.13301']
1751,33112481,Faecal regenerating 1B protein concentration is not associated with child growth in rural Malawi.,"AIM


This study was designed to determine whether faecal regenerating 1B protein (REG1B) concentration is associated with physical growth among 6-30-month-old children in rural Malawi.
METHODS


This was a secondary analysis from a randomised controlled trial in rural Malawi in which we followed-up 790 live-born infants from birth to 30 months of age. We collected anthropometric data at the age of 6, 12, 18, 24 and 30 months. We measured faecal REG1B concentration by enzyme-linked immunosorbent assay (ELISA) technique using stool samples collected at 6, 18 and 30 months of age. We assessed the association between faecal REG1B concentration and children's physical growth using linear regression and longitudinal data analysis.
RESULTS


Of 790 live-born infants enrolled, 694 (87%) with at least one faecal REG1B concentration measurement were included in the analysis. Faecal REG1B concentration was not associated with the children's concurrent length-for-age z-score (LAZ), weight-for-age z-score (WAZ), weight-for-length z-score (WLZ) and mid-upper arm circumference-for-age z-score (MUACZ) at any time point (P > 0.05), nor with a change in their anthropometric indices in the subsequent 6-month period (P > 0.05).
CONCLUSIONS


Faecal REG1B concentration is not associated with LAZ, WAZ, WLZ and MUACZ among 6-30-month-old infants and children in rural Malawi.",2020,"CONCLUSIONS


Faecal REG1B concentration is not associated with LAZ, WAZ, WLZ and MUACZ among 6-30-month-old infants and children in rural Malawi.","['Of 790 live-born infants enrolled, 694 (87%) with at least one', 'rural Malawi in which we followed-up 790 live-born infants from birth to 30\u2009months of age', '6-30-month-old infants and children in rural Malawi', '6-30-month-old children in rural Malawi']","['LAZ, WAZ, WLZ and MUACZ']","['faecal REG1B concentration measurement', 'faecal REG1B concentration by enzyme-linked immunosorbent assay (ELISA) technique', 'Faecal REG1B concentration']","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0886219,"CONCLUSIONS


Faecal REG1B concentration is not associated with LAZ, WAZ, WLZ and MUACZ among 6-30-month-old infants and children in rural Malawi.","[{'ForeName': 'Zhifei', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Hallamaa', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Hyöty', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Public Health, School of Public Health & Family Medicine, College of Medicine, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Kirsi-Maarit', 'Initials': 'KM', 'LastName': 'Lehto', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Oikarinen', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Parkkila', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",Journal of paediatrics and child health,['10.1111/jpc.15231']
1752,33108212,Risk of Exacerbation and Pneumonia with Single Inhaler Triple Versus Dual Therapy in IMPACT.,"RATIONALE


In the Informing the Pathway of COPD Treatment (IMPACT) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy reduced exacerbation risk versus FF/VI and UMEC/VI and mortality risk versus UMEC/VI. However, pneumonia incidence was higher in the inhaled corticosteroid (FF)-containing arms raising questions about the relative benefit of exacerbation reduction compared with the increased risk of pneumonia.
OBJECTIVES


Determine benefit-risk of the three treatments by evaluating time-to-first and rates of composite exacerbation or pneumonia outcomes.
METHODS


We evaluated time-to-first (pre-specified) and rates (post hoc) of investigator-reported pneumonia, serious pneumonia leading to hospitalization or death, and the composite endpoints of 1) moderate (required antibiotics/corticosteroids)/severe (hospitalized) exacerbation or pneumonia and 2) severe exacerbation or serious (hospitalized) pneumonia. Analyses were repeated for radiographically confirmed pneumonia (post hoc).
RESULTS


Moderate/severe exacerbations occurred in 47%, 49%, and 50% of patients randomized to FF/UMEC/VI, FF/VI and UMEC/VI, and pneumonias in 8%, 7%, and 5%, respectively. FF/UMEC/VI reduced the risk of combined moderate/severe exacerbation or pneumonia (time-to-first) versus FF/VI (hazard ratio 0.87 [95%CI 0.82-0.92]) and UMEC/VI (0.87 [0.81-0.94]), as well as the risk of combined severe exacerbation or serious pneumonia versus UMEC/VI (0.83 [0.72-0.96]). FF/UMEC/VI reduced the rate of combined moderate/severe exacerbation or pneumonia (rate ratio 0.78 [0.72-0.84]) and combined severe exacerbation or serious pneumonia (rate ratio 0.76 [0.65-0.89]) versus UMEC/VI. Results were similar for radiographically confirmed pneumonia endpoints.
CONCLUSIONS


Despite higher incidence of pneumonia in FF-containing arms, these composite exacerbation/pneumonia outcomes support a favorable benefit-risk profile of FF/UMEC/VI versus FF/VI and UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.
CLINICAL TRIAL REGISTRATION


CTT116855/NCT02164513.",2020,FF/UMEC/VI reduced the rate of combined moderate/severe exacerbation or pneumonia (rate ratio 0.78 [0.72-0.84]) and combined severe exacerbation or serious pneumonia (rate ratio 0.76 [0.65-0.89]) versus UMEC/VI.,['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI'],"['risk of combined severe exacerbation or serious pneumonia', 'risk of combined moderate/severe exacerbation or pneumonia', 'rate of combined moderate/severe exacerbation or pneumonia', 'combined severe exacerbation or serious pneumonia', 'exacerbation risk versus FF/VI and UMEC/VI and mortality risk', 'time-to-first (pre-specified) and rates (post hoc) of investigator-reported pneumonia, serious pneumonia leading to hospitalization or death, and the composite endpoints of 1) moderate (required antibiotics/corticosteroids)/severe (hospitalized) exacerbation or pneumonia and 2) severe exacerbation or serious (hospitalized) pneumonia', 'severe exacerbations', 'pneumonia incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.589764,FF/UMEC/VI reduced the rate of combined moderate/severe exacerbation or pneumonia (rate ratio 0.78 [0.72-0.84]) and combined severe exacerbation or serious pneumonia (rate ratio 0.76 [0.65-0.89]) versus UMEC/VI.,"[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'University of Alabama at Birmingham, 9968, Medicine/Pulmonary, Allergy and Critical Care, Birmingham, Alabama, United States; mdransfield@uabmc.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Clinical Sciences - Respiratory, Research Triangle Park, North Carolina, United States.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, 12314, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, 171002, Exeter, Devon, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, 1259, Pulmonary and Critical Care, Ann Arbor, Michigan, United States.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Research Triangle Park, North Carolina, United States.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'LaFon', 'Affiliation': 'University of Alabama at Birmingham, 9968, Birmingham, Alabama, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Clinical Sciences, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'University College London, 4919, UCL Respiratory, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Brentford, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'NewYork-Presbyterian Hospital/Weill Cornell Medical Center, 159947, New York, New York, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The University of Manchester, 5292, Manchester Academic Health Science Centre, Manchester, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins Medicine, 1501, Division of Pulmonary and Critical Care Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, 4321, Section of Epidemiology, Department of Public Health, Kobenhavn, Denmark.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202002-096OC']
1753,33108398,Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial.,"BACKGROUND


The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention.
METHODS


Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months.
RESULTS


47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients' underlying co-morbidities.
CONCLUSIONS


SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.",2020,Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively.,"['dysfunctional arterio-venous fistulas', 'end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020', 'Asian haemodialysis patients', 'Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years']","['MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US', 'SCB angioplasty', 'sirolimus coated balloon angioplasty']","['Circuit access patency rates', 'target lesion primary patency rates', 'efficacy and safety', 'peri-procedural complications', 'safety and efficacy', 'patency of failing arterio-venous fistulas']","[{'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]",33.0,0.0446635,Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively.,"[{'ForeName': 'Tjun Y', 'Initials': 'TY', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Shereen X Y', 'Initials': 'SXY', 'LastName': 'Soon', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Charyl J Q', 'Initials': 'CJQ', 'LastName': 'Yap', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Sze Ling', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'Health Services Research Center, SingHealth, Singapore, Singapore.'}, {'ForeName': 'Ru Yu', 'Initials': 'RY', 'LastName': 'Tan', 'Affiliation': 'Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Suh Chien', 'Initials': 'SC', 'LastName': 'Pang', 'Affiliation': 'Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Shaun Q W', 'Initials': 'SQW', 'LastName': 'Lee', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hao Yun', 'Initials': 'HY', 'LastName': 'Yap', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Edward T C', 'Initials': 'ETC', 'LastName': 'Choke', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chieh Suai', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Tze Tec', 'Initials': 'TT', 'LastName': 'Chong', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0241321']
1754,33108442,Anesthesiologist Age and Sex Influence Patient Perceptions of Physician Competence.,"BACKGROUND


Uncovering patients' biases toward characteristics of anesthesiologists may inform ways to improve the patient-anesthesiologist relationship. The authors previously demonstrated that patients prefer anesthesiologists displaying confident body language, but did not detect a sex bias. The effect of anesthesiologists' age on patient perceptions has not been studied. In this follow-up study, it was hypothesized that patients would prefer older-appearing anesthesiologists over younger-appearing anesthesiologists and male over female anesthesiologists.
METHODS


Three hundred adult, English-speaking patients were recruited in the Preanesthesia Evaluation and Testing Center. Patients were randomized (150 per group) to view a set of four videos in random order. Each 90-s video featured an older female, older male, younger female, or younger male anesthesiologist reciting the same script describing general anesthesia. Patients ranked each anesthesiologist on confidence, intelligence, and likelihood of choosing the anesthesiologist to care for their family member. Patients also chose the one anesthesiologist who seemed most like a leader.
RESULTS


Three hundred patients watched the videos and completed the questionnaire. Among patients younger than age 65 yr, the older anesthesiologists had greater odds of being ranked more confident (odds ratio, 1.92; 95% CI, 1.41 to 2.64; P < 0.001) and more intelligent (odds ratio, 2.24; 95% CI, 1.62 to 3.11; P < 0.001), and had greater odds of being considered a leader (odds ratio, 2.62; 95% CI, 1.72 to 4.00; P < 0.001) when compared with younger anesthesiologists. The preference for older anesthesiologists was not observed in patients age 65 and older. Female anesthesiologists had greater odds of being ranked more confident (odds ratio, 1.46; 95% CI, 1.13 to 1.87; P = 0.003) and more likely to be chosen to care for one's family member (odds ratio, 1.80; 95% CI, 1.40 to 2.31; P < 0.001) compared with male anesthesiologists. The ranking preference for female anesthesiologists on these two measures was observed among white patients and not among nonwhite patients.
CONCLUSIONS


Patients preferred older anesthesiologists on the measures of confidence, intelligence, and leadership. Patients also preferred female anesthesiologists on the measures of confidence and likelihood of choosing the anesthesiologist to care for one's family member.
EDITOR’S PERSPECTIVE


",2020,"Female anesthesiologists had greater odds of being ranked more confident (odds ratio, 1.46; 95% CI, 1.13 to 1.87; P = 0.003) and more likely to be chosen to care for one's family member (odds ratio, 1.80; 95% CI, 1.40 to 2.31; P < 0.001) compared with male anesthesiologists.","['patients would prefer older-appearing anesthesiologists over younger-appearing anesthesiologists and male over female anesthesiologists', 'patients younger than age 65 yr', 'Three hundred adult, English-speaking patients were recruited in the Preanesthesia Evaluation and Testing Center', 'patients age 65 and older', 'older female, older male, younger female, or younger male anesthesiologist reciting the same script describing general anesthesia']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0474221', 'cui_str': 'Pre-anesthetic assessment'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]",[],[],300.0,0.0539526,"Female anesthesiologists had greater odds of being ranked more confident (odds ratio, 1.46; 95% CI, 1.13 to 1.87; P = 0.003) and more likely to be chosen to care for one's family member (odds ratio, 1.80; 95% CI, 1.40 to 2.31; P < 0.001) compared with male anesthesiologists.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Forkin', 'Affiliation': ''}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Naveen C', 'Initials': 'NC', 'LastName': 'Kotha', 'Affiliation': ''}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Bechtel', 'Affiliation': ''}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kleiman', 'Affiliation': ''}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Huffmyer', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Genevieve R', 'Initials': 'GR', 'LastName': 'Lyons', 'Affiliation': ''}, {'ForeName': 'Jennie Z', 'Initials': 'JZ', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Nemergut', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003595']
1755,33108521,"Effects of high intake of cod or salmon on gut microbiota profile, faecal output and serum concentrations of lipids and bile acids in overweight adults: a randomised clinical trial.","PURPOSE


To explore whether high intake of cod or salmon would affect gut microbiota profile, faecal output and serum concentrations of lipids and bile acids.
METHODS


Seventy-six adults with overweight/obesity with no reported gastrointestinal disease were randomly assigned to consume 750 g/week of either cod or salmon, or to avoid fish intake (Control group) for 8 weeks. Fifteen participants from each group were randomly selected for 72 h faeces collection at baseline and end point for gut microbiota profile analyses using 54 bacterial DNA probes. Food intake was registered, and fasting serum and morning urine were collected at baseline and end point.
RESULTS


Sixty-five participants were included in serum and urine analyses, and gut microbiota profile was analysed for 33 participants. Principal component analysis of gut microbiota showed an almost complete separation of the Salmon group from the Control group, with lower counts for bacteria in the Bacteroidetes phylum and the Clostridiales order of the Firmicutes phyla, and higher counts for bacteria in the Selenomonadales order of the Firmicutes phylum. The Cod group showed greater similarity to the Salmon group than to the Control group. Intake of fibres, proteins, fats and carbohydrates, faecal daily mass and output of fat, cholesterol and total bile acids, and serum concentrations of cholesterol, triacylglycerols, non-esterified fatty acids and total bile acids were not altered in the experimental groups.
CONCLUSION


A high intake of cod or salmon fillet modulated gut microbiota but did not affect faecal output or serum concentrations of lipids and total bile acids.
CLINICAL TRIAL REGISTRATION


This trial was registered at clinicaltrials.gov as NCT02350595.",2020,"A high intake of cod or salmon fillet modulated gut microbiota but did not affect faecal output or serum concentrations of lipids and total bile acids.
","['Fifteen participants from each group', 'Seventy-six adults with overweight/obesity with no reported gastrointestinal disease', 'Sixty-five participants were included in', 'overweight adults']","['cod or salmon, or to avoid fish intake (Control group) for 8\xa0weeks', 'cod or salmon']","['serum and urine analyses, and gut microbiota profile', 'gut microbiota profile, faecal output and serum concentrations of lipids and bile acids', 'fasting serum and morning urine', 'Intake of fibres, proteins, fats and carbohydrates, faecal daily mass and output of fat, cholesterol and total bile acids, and serum concentrations of cholesterol, triacylglycerols, non-esterified fatty acids and total bile acids', 'faecal output or serum concentrations of lipids and total bile acids']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0556216', 'cui_str': 'Fish intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}]",65.0,0.0856809,"A high intake of cod or salmon fillet modulated gut microbiota but did not affect faecal output or serum concentrations of lipids and total bile acids.
","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bratlie', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, Haukeland University Hospital, University of Bergen, 5021, Bergen, Norway.'}, {'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Hagen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, Haukeland University Hospital, University of Bergen, 5021, Bergen, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Helland', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, Haukeland University Hospital, University of Bergen, 5021, Bergen, Norway.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Erchinger', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Rosenlund', 'Affiliation': 'Skretting Aquaculture Research Centre AS, P.O. Box 48, 4001, Stavanger, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sveier', 'Affiliation': 'Lerøy Seafood Group ASA, P.O. Box 7600, 5020, Bergen, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Mohn Nutrition Research Laboratory, Department of Clinical Science, Haukeland University Hospital, University of Bergen, 5021, Bergen, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Oddrun Anita', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, Haukeland University Hospital, University of Bergen, 5021, Bergen, Norway. oddrun.gudbrandsen@k1.uib.no.'}]",European journal of nutrition,['10.1007/s00394-020-02417-8']
1756,33108543,Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.,"BACKGROUND


Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials.
OBJECTIVES


The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.
METHODS


In a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18-49 years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150 mg once daily, elagolix 200 mg twice daily, or placebo for 6 months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated.
RESULTS


The analysis included 871 women, mean age 31.5 years. Internal consistency supported a single concept (Cronbach's alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p = 0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p < 0.0001).
CONCLUSIONS


PROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.",2020,"PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6.","['women with moderate-to-severe endometriosis-associated pain', 'women aged 18-49\u2009years with moderate-to-severe endometriosis-related pain', '871 women, mean age 31.5\u2009years']","['placebo', 'elagolix 150\u2009mg once daily, elagolix 200\u2009mg twice daily, or placebo']","['Patient Global Impression of Change (PGIC', 'PROMIS Fatigue', 'PROMIS Fatigue T-score', 'PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores', 'clinically relevant anchors (dysmenorrhea and NMPP', 'Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0857094', 'cui_str': 'Endometriosis related pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",871.0,0.237538,"PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera Inc., 7101 Wisconsin Ave., Suite 1400, Bethesda, MD, 20814, USA. robin.pokrzywinski@evidera.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Surrey', 'Affiliation': 'Colorado Center for Reproductive Medicine, Lone Tree, CO, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera Inc., 7101 Wisconsin Ave., Suite 1400, Bethesda, MD, 20814, USA.'}]",Journal of patient-reported outcomes,['10.1186/s41687-020-00257-y']
1757,33108574,Single-Session Cerebellar Transcranial Direct Current Stimulation Affects Postural Control Learning and Cerebellar Brain Inhibition in Healthy Individuals.,"Cerebellar transcranial direct current stimulation (ctDCS) modulates cerebellar activity and postural control. However, the effects of ctDCS on postural control learning and the mechanisms associated with these effects remain unclear. To examine the effects of single-session ctDCS on postural control learning and cerebellar brain inhibition (CBI) of the primary motor cortex in healthy individuals. In this triple-blind, sham-controlled study, 36 participants were allocated randomly to one of three groups: (1) anodal ctDCS group, (2) cathodal ctDCS group, and (3) sham ctDCS group. ctDCS (2 mA) was applied to the cerebellar brain for 20 min prior to six blocks of standing postural control training (each block consisted of five trials of a 30-s tracking task). CBI and corticospinal excitability of the tibialis anterior muscle were assessed at baseline, immediately after, 1 day after, and 7 days after training. Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group. Changes in performance measured 1 day after and 7 days after training did not differ among the groups. In the anodal ctDCS group, CBI significantly increased after training, whereas corticospinal excitability decreased. Anodal ctDCS-induced CBI changes were correlated with the learning formation of postural control (r = 0.55, P = 0.04). Single-session anodal and cathodal ctDCS could suppress the skill acquisition of postural control in healthy individuals. The CBI changes induced by anodal ctDCS may affect the learning process of postural control.",2020,Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group.,"['36 participants', 'Healthy Individuals', 'healthy individuals']","['ctDCS', 'standing postural control training', 'Cerebellar transcranial direct current stimulation (ctDCS', 'single-session ctDCS', 'anodal ctDCS group, (2) cathodal ctDCS group, and (3) sham ctDCS', 'Single-session anodal and cathodal ctDCS', 'anodal ctDCS', 'Single-Session Cerebellar Transcranial Direct Current Stimulation']","['postural control learning', 'CBI and corticospinal excitability of the tibialis anterior muscle', 'corticospinal excitability', 'CBI', 'learning formation of postural control', 'Anodal ctDCS-induced CBI changes', 'skill acquisition of postural control', 'postural control learning and cerebellar brain inhibition (CBI', 'Skill acquisition']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",36.0,0.0282038,Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group.,"[{'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Katagiri', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kawakami', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Okuyama', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Tadaki', 'Initials': 'T', 'LastName': 'Koseki', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kudo', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Namba', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, 470-1192, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan. t.yamaguchi.ja@juntendo.ac.jp.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01208-5']
1758,33108582,Longer-Term Outcomes of the Incredible Years Parenting Intervention.,"Conduct problems can develop into behavior disorders and put children at risk for other mental health problems. Parenting interventions have been shown to successfully reduce conduct problems and are often expected to prevent the development of broader mental health problems. Few studies have evaluated the longer-term and broader effects of these interventions. To what extent are parenting intervention effects sustained in the years after the intervention? And do effects pertain to conduct problems specifically, or do they also affect broader aspects of children's mental health? We used a randomized controlled trial to assess the longer-term (2.5 years) effects of the Incredible Years parenting intervention on children's conduct problems in an indicated prevention setting (N = 387; 79% retention rate). Using a multi-method (survey and computerized tasks) and multi-informant (parents, teachers, and children) approach, we tested whether initial effects on conduct problems were sustained, and whether Incredible Years had broader effects on children's peer problems, emotional problems, attention-deficit/hyperactivity disorder (ADHD) symptoms, attention and inhibition deficits, and service use. Incredible Years, relative to control (no intervention), led to sustained reductions in parent-reported conduct problems (Cohen's d = 0.31), but not teacher- and child-reported conduct problems. There were no broader benefits: Incredible Years did not reduce children's peer problems, emotional problems, ADHD-symptoms, attention and inhibition deficits, or their service use. Improvements in parents' perceptions of child conduct problems sustained until 2.5 years later. Our findings do not show benefits of Incredible Years as a preventive intervention for children's broader mental health.",2020,"There were no broader benefits: Incredible Years did not reduce children's peer problems, emotional problems, ADHD-symptoms, attention and inhibition deficits, or their service use.","[""children's conduct problems in an indicated prevention setting (N\u2009=\u2009387; 79% retention rate""]",['Incredible Years parenting intervention'],"[""children's peer problems, emotional problems, ADHD-symptoms, attention and inhibition deficits, or their service use"", ""children's peer problems, emotional problems, attention-deficit/hyperactivity disorder (ADHD) symptoms, attention and inhibition deficits, and service use""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3532917', 'cui_str': 'Peer problem'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.139408,"There were no broader benefits: Incredible Years did not reduce children's peer problems, emotional problems, ADHD-symptoms, attention and inhibition deficits, or their service use.","[{'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands. g.overbeek@uva.nl.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'van Aar', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bram Orobio', 'Initials': 'BO', 'LastName': 'de Castro', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Matthys', 'Affiliation': 'Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Weeland', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rabia R', 'Initials': 'RR', 'LastName': 'Chhangur', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Leijten', 'Affiliation': 'Research Institute Child Development and Education, University of Amsterdam, Amsterdam, The Netherlands.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01176-6']
1759,33108617,Pharmacokinetics and Clinical Implications of Oral Semaglutide for Type 2 Diabetes Mellitus.,"Since the approval of subcutaneous glucagon-like peptide-1 receptor agonists, this therapeutic class has become a preferred choice for the management of type 2 diabetes due to A1C reduction, minimal risk of hypoglycemia, weight loss, and cardiovascular benefit. An oral option, with gastrointestinal absorption, would overcome any potential fear of injection among patients. Oral semaglutide has been studied in randomized controlled trials within the PIONEER program. From a robust pool of literature with a global patient population, oral semaglutide has been an effective option as monotherapy and combination therapy to improve clinical outcomes, such as A1C and body weight from baseline to week 78, depending on the randomized controlled trial. In addition, a noninferiority result was observed with oral semaglutide versus placebo in a cardiovascular outcomes trial in patients with type 2 diabetes with established cardiovascular disease or risk factors. Similar to injectable glucagon-like peptide 1 receptor agonists, transient nausea and vomiting was seen with oral semaglutide. Overall, this new oral option may be a choice for patients with barriers to injectable therapy. This review evaluates and summarizes the pharmacokinetics, pharmacodynamics, and clinical application of oral semaglutide in patients with type 2 diabetes.",2020,"Similar to injectable glucagon-like peptide 1 receptor agonists, transient nausea and vomiting was seen with oral semaglutide.","['Type 2 Diabetes Mellitus', 'patients with barriers to injectable therapy', 'patients with type 2 diabetes', 'patients with type 2 diabetes with established cardiovascular disease or risk factors']","['placebo', 'Oral Semaglutide']",['nausea and vomiting'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.0309448,"Similar to injectable glucagon-like peptide 1 receptor agonists, transient nausea and vomiting was seen with oral semaglutide.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Clements', 'Affiliation': 'Department of Nursing Administration, Spartanburg Regional Healthcare System, Spartanburg, SC, 29303, USA. Jclements1027@outlook.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Isaacs', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Cleveland Clinic Diabetes Center, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Hartman', 'Affiliation': 'The University of Findlay College of Pharmacy, Findlay, OH, 45840, USA.'}, {'ForeName': 'Kennedy', 'Initials': 'K', 'LastName': 'Gambill', 'Affiliation': 'Department of Pharmacy, Spartanburg Medical Center, Spartanburg, SC, 29303, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00951-6']
1760,33108622,"Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19.","INTRODUCTION


The COVID-19 global pandemic caused by the novel coronavirus, SARS-CoV-2, and the consequent morbidity and mortality attributable to progressive hypoxemia and subsequent respiratory failure threaten to overrun hospital critical care units globally. New agents that address the hyperinflammatory ""cytokine storm"" and hypercoagulable pathology seen in these patients may be a promising approach to treat patients, minimize hospital stays, and ensure hospital wards and critical care units are able to operate effectively. Dociparstat sodium (DSTAT) is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, with the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding compared to commercially available heparin.
METHODS


This study is a randomized, double-blind, placebo-controlled, phase 2/3 trial to determine the safety and efficacy of DSTAT added to standard of care in hospitalized adults with COVID-19 who require supplemental oxygen. Phase 2 will enroll 12 participants in each of two dose-escalating cohorts to confirm the safety of DSTAT in this population. Following review of the data, an additional 50 participants will be enrolled. Contingent upon positive results, phase 3 will enroll approximately 450 participants randomized to DSTAT or placebo. The primary endpoint is the proportion of participants who survive and do not require mechanical ventilation through day 28.
DISCUSSION


Advances in standard of care, recent emergency use authorizations, and positive data with dexamethasone have likely contributed to an increasing proportion of patients who are surviving without the need for mechanical ventilation. Therefore, examining the time to improvement in the NIAID score will be essential to provide a measure of drug effect on recovery. Analysis of additional endpoints, including supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer), will be performed to further define the effect of DSTAT in patients with COVID-19 infection.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT04389840, Registered 13 May 2020.",2020,"Analysis of additional endpoints, including supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer), will be performed to further define the effect of DSTAT in patients with COVID-19 infection.
","['patients with COVID-19 infection', '50 participants will be enrolled', 'Acute Lung Injury Associated with Severe COVID-19', 'patients who are surviving without the need for mechanical ventilation', 'hospitalized adults with COVID-19 who require supplemental oxygen']","['placebo', 'Dociparstat sodium (DSTAT', 'Placebo', 'dexamethasone']","['supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer', 'proportion of participants who survive and do not require mechanical ventilation through day 28', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",450.0,0.688061,"Analysis of additional endpoints, including supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer), will be performed to further define the effect of DSTAT in patients with COVID-19 infection.
","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Lasky', 'Affiliation': 'Tulane University Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Fuloria', 'Affiliation': 'University Medical Center New Orleans, New Orleans, LA, USA.'}, {'ForeName': 'Marion E', 'Initials': 'ME', 'LastName': 'Morrison', 'Affiliation': 'Chimerix, Inc, Durham, NC, USA. mmorrison@chimerix.com.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Lanier', 'Affiliation': 'Chimerix, Inc, Durham, NC, USA.'}, {'ForeName': 'Odin', 'Initials': 'O', 'LastName': 'Naderer', 'Affiliation': 'Chimerix, Inc, Durham, NC, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Brundage', 'Affiliation': 'Chimerix, Inc, Durham, NC, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Melemed', 'Affiliation': 'Chimerix, Inc, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01539-z']
1761,33108624,Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study.,"INTRODUCTION


We investigate the safety and efficacy of telmisartan plus S-amlodipine single-pill combination in a real-world population.
METHODS


A total of 44,715 patients who had hypertension and received a telmisartan/S-amlodipine single-pill combination at least once were included for safety and efficacy evaluation from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019. They were followed up for 3-6 months in terms of safety and efficacy of blood pressure (BP) lowering.
RESULTS


A total of 44,715 patients were included for safety analysis and 41,579 for efficacy analysis. Mean duration of taking the drug was 175.86 ± 48.45 days. A total of 28,096 (62.8%) patients were on telmisartan 40 mg plus S-amlodipine 2.5 mg combination followed by 80/2.5 mg (8664, 19.4%) and 40/5 mg of the drug (7136, 16.0%). Adverse events, total adverse drug reactions, and serious adverse drug reactions were found in 808 patients (1.81%), 352 (0.79%), and 1 (0.002%), respectively. Dizziness and headache were most common (134 [0.30%] and 81 [0.18%]) among all adverse events. Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively. Systolic BP (SBP) and diastolic BP (DBP) was lowered from 143.1 ± 16.1/88.1 ± 11.8 mmHg to 129.6 ± 11.4/80.1 ± 9.0 mmHg (difference - 13.5/- 7.9 mmHg, P < 0.0001 for both). Target BP goal attainment rate defined as SBP < 140 mmHg and DBP < 90 mmHg was 74.6% (95% confidence interval [CI] 74.2-75.0) and BP response rate (defined as SBP < 140 mmHg or ≥ 20 mmHg reduction; DBP < 90 mmHg or ≥ 10 mmHg reduction) was 94.5% (95% CI 94.3-94.7).
CONCLUSION


Telmisartan plus S-amlodipine single-pill combination was safe and effective in patients with hypertension in a large real-world population.",2020,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","['Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study', 'patients with hypertension in a large real-world population', '44,715 patients who had hypertension and received a', 'A total of 28,096 (62.8%) patients were on', '44,715 patients', 'from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019']","['telmisartan plus S-amlodipine single-pill combination', 'telmisartan/S-amlodipine single-pill combination', 'Telmisartan plus S-amlodipine single-pill combination', 'telmisartan 40\xa0mg plus S-amlodipine', 'Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy']","['Total edema and leg edema', 'Adverse events, total adverse drug reactions, and serious adverse drug reactions', 'safety and efficacy of blood pressure (BP) lowering', 'safety and efficacy', 'Target BP goal attainment rate', 'BP response rate', 'safety and efficacy evaluation', 'Systolic BP (SBP) and diastolic BP (DBP', 'Dizziness and headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0990502', 'cui_str': 'telmisartan 40 MG'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",44715.0,0.107475,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","[{'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Jo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sung-Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Cardiovascular Imaging Center, Samsung Medical Center, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Cardiovascular-Arrhythmia Center, Chung-Ang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea. parkcg@kumc.or.kr.'}]",Advances in therapy,['10.1007/s12325-020-01533-5']
1762,33108633,Siponimod: A Review in Secondary Progressive Multiple Sclerosis.,"Oral siponimod (Mayzent ® ), a next-generation, selective sphingosine 1-phosphate receptor (S1PR) 1 and 5 modulator, is approved in several countries for the treatment of secondary progressive multiple sclerosis (SPMS), with specific indications varying between individual countries. In the pivotal EXPAND trial (median duration double-blind treatment 18 months) in a broad spectrum of patients with SPMS, once-daily oral siponimod 2 mg (initial dose titration over 6 days) was significantly more effective than placebo in reducing clinical and MRI-defined outcomes of disease activity and disability progression, including 3-month confirmed disability progression on the Expanded Disability Status Scale (EDSS), and was generally well tolerated in the core phase of the study. These beneficial effects of siponimod appeared to be sustained during up to 5 years of treatment in the ongoing open-label extension phase of EXPAND. The safety profile of siponimod is similar to that of other agents in its class, including adverse events of special interest (i.e. those known to be associated with S1PR modulators). No new safety signals were identified during up to 5 years' treatment in the open-label extension phase. Albeit further long-term efficacy and safety data from the real-world setting are required to fully define its role, given the paucity of current treatment options and its convenient dosage regimen, siponimod represents an important emerging option for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging-features of inflammatory activity.",2020,"Oral siponimod (Mayzent ® ), a next-generation, selective sphingosine 1-phosphate receptor (S1PR) 1 and 5 modulator, is approved in several countries for the treatment of secondary progressive multiple sclerosis (SPMS), with specific indications varying between individual countries.",['adult patients with SPMS with active disease'],"['Oral siponimod (Mayzent ® ', 'placebo']","['disease activity and disability progression', 'Expanded Disability Status Scale (EDSS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3657824', 'cui_str': 'siponimod'}, {'cui': 'C4764790', 'cui_str': 'Mayzent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]",,0.0172539,"Oral siponimod (Mayzent ® ), a next-generation, selective sphingosine 1-phosphate receptor (S1PR) 1 and 5 modulator, is approved in several countries for the treatment of secondary progressive multiple sclerosis (SPMS), with specific indications varying between individual countries.","[{'ForeName': 'Lesley J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",CNS drugs,['10.1007/s40263-020-00771-z']
1763,33108650,"A Prospective, Open-Label Short-Term Pilot Study on Modification of the Skin Hydration Status During Treatment With a Sodium-Glucose Cotransporter-2 Inhibitor.","INTRODUCTION


Various types of skin lesions with pruritus have been reported in participants of Asian clinical trials on sodium-glucose cotransporter-2 (SGLT2) inhibitors. The aim of this study was to determine whether the diuretic effect of a SGLT2 inhibitor could modify skin hydration status in patients with type 2 diabetes mellitus.
METHODS


A prospective, short-term, open-label, two-parallel-arm, pilot study was conducted. Eligible patients were assigned to either a SGLT2 inhibitor (50 mg ipragliflozin once daily) group or to a dipeptidyl peptidase-4 inhibitor (50 mg sitagliptin once daily) group (control). The biophysical characteristics of the skin were measured and blood chemistry tests were run in all participants 1 day prior to medication initiation (pre-treatment values) and 14 days thereafter (post-treatment values).
RESULTS


Fourteen patients were enrolled in the study, of whom eight were in the ipragliflozin group and six in the sitagliptin group. Compared to the pre-treatment values, the glycated hemoglobin (HbA1c) levels were slightly but significantly reduced in the ipragliflozin group (p = 0.02), but the changes in HbA1c from the pre-treatment to post-treatment time points did not significantly differ between the two treatment groups. Serum 3-hydroxy butyrate levels were significantly higher in the ipragliflozin group than in the sitagliptin group (p < 0.02). Neither electrical capacitance nor electrical conductance of the stratum corneum (SC), parameters that reflect skin water content, was reduced by 14 days of ipragliflozin treatment; similarly, no changes in these parameters were found in the sitagliptin control group. There was also no difference in the changes in water barrier function of the SC between the two treatment groups. There was a significant linear correlation (p < 0.01) in skin water content at pre-treatment and that 14 days after treatment with each drug, respectively.
CONCLUSION


Ipragliflozin treatment for 14 days did not significantly affect the skin hydration status in patients with well-controlled type 2 diabetes mellitus.",2020,Serum 3-hydroxy butyrate levels were significantly higher in the ipragliflozin group than in the sitagliptin group (p < 0.02).,"['patients with type 2 diabetes mellitus', 'Eligible patients', 'patients with well-controlled type 2 diabetes mellitus', 'Fourteen patients were enrolled in the study, of whom eight were in the ipragliflozin group and six in the sitagliptin group']","['ipragliflozin', 'SGLT2 inhibitor (50\xa0mg ipragliflozin once daily) group or to a dipeptidyl peptidase-4 inhibitor (50\xa0mg sitagliptin once daily) group (control', 'Ipragliflozin', 'Sodium-Glucose Cotransporter-2 Inhibitor', 'SGLT2 inhibitor']","['skin hydration status', 'glycated hemoglobin (HbA1c) levels', 'Serum 3-hydroxy butyrate levels', 'Skin Hydration Status', 'water barrier function', 'electrical capacitance nor electrical conductance of the stratum corneum (SC), parameters that reflect skin water content', 'skin water content']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",14.0,0.0178935,Serum 3-hydroxy butyrate levels were significantly higher in the ipragliflozin group than in the sitagliptin group (p < 0.02).,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tezuka', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Sekine', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hirano', 'Affiliation': 'R&D Department, Sunstar Inc., 3-1 Asahi-machi, Takatsuki, Osaka, 569-1195, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Hanada', 'Affiliation': 'R&D Department, Sunstar Inc., 3-1 Asahi-machi, Takatsuki, Osaka, 569-1195, Japan.'}, {'ForeName': 'Ikuhisa', 'Initials': 'I', 'LastName': 'Nakanishi', 'Affiliation': 'R&D Department, Sunstar Inc., 3-1 Asahi-machi, Takatsuki, Osaka, 569-1195, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Ariga', 'Affiliation': 'R&D Department, Sunstar Inc., 3-1 Asahi-machi, Takatsuki, Osaka, 569-1195, Japan.'}, {'ForeName': 'Choka', 'Initials': 'C', 'LastName': 'Azuma', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ito-Kobayashi', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Washiyama', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Iwanishi', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Furuta', 'Affiliation': 'Department of Dermatology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Kanamori', 'Affiliation': 'College of Health and Sport Science, Ritsumeikan University, 1-1-1 Noji Higashi, Kusatsu, Shiga, 525-8577, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kashiwagi', 'Affiliation': 'Department of Diabetes and Endocrinology, Kusatsu General Hospital, 1660 Yabase, Kusatsu, Shiga, 525-8585, Japan. kashiwagi@kusatsu-gh.or.jp.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00950-7']
1764,33108690,"Preventive interventions for children in organized team sport tackling aggression: Results from the pilot evaluation of ""Fairplayer.Sport"".","Current reviews revealed that there is a lack of effective programs and valuable effectiveness studies related to prevention of aggressive behavior and fostering of social competence in early adolescents participating in organized team sports (e.g., ball sports, such as soccer). Using a randomized controlled design, the present pilot study presents first results regarding the effectiveness of the preventive intervention program ""Fairplayer.Sport"" that was implemented with preadolescent soccer players (N = 145 preadolescents; aged 9-14 years; mean = 12.2 years) in organized team sport (13 soccer teams). Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size). This effect remained stable 3 months after program implementation. Implications for planning and implementing preventive intervention programs are discussed.",2020,Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size).,"['children in organized team sport tackling aggression', 'preadolescent soccer players (N = 145 preadolescents', 'aged 9-14 years; mean = 12.2 years) in organized team sport (13 soccer teams']",[],['aggressive behavior'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",,0.0208526,Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size).,"[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Education and Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, Berlin, 14195, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Leppin', 'Affiliation': 'Department of Psychology, Philipps-Universität Marburg, Gutenbergstraße 18, Marburg, 35032, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hess', 'Affiliation': 'Applied Developmental and Social Psychology, German University of Health and Sports, Franklinstraße 28-29, Berlin, 10587, Germany.'}]",New directions for child and adolescent development,['10.1002/cad.20380']
1765,31950384,Effectiveness of adjuvant supportive-expressive group therapy for breast cancer.,"PURPOSE


Randomized control trials exploring adjuvant supportive-expressive group therapy (SEGT) for breast cancer have yielded conflicting survival results. This retrospective cohort study was designed to explore the association of adjuvant SEGT performed at diagnosis with survival in real-world patients.
METHODS


3327 patients with breast cancer were divided between those who received oncologic treatment combined with SEGT-based intervention (referred to as BRBC [n = 354]) and those who only received oncologic treatment (referred to as OT [n = 2973]). Primary outcome was overall survival (OS) at 1-year, 3-year, 5-year. Propensity score-matched analysis (at a ratio of 1:3) and instrumental variable analysis (IVA) were performed.
RESULTS


The median overall survival was 7.3 years (95% CI 7.0-7.7 years) in BRBC and 7.1 years (95% CI 6.9-7.4 years) in OT. BRBC was not significantly associated with improved 1-year (HR 0.74, 95% CI 0.49-1.10, P = 0.1748; NNT = 44.8, 95% CI - 118.5 to 22.6), 3-year (HR 0.98, 95% CI 0.75-1.27, P = 0.8640; NNT = 273.7, 95% CI - 21.0 to 21.3), or 5-year survival (HR 0.79, 95% CI 0.61-1.02, P = 0.0908; NNT = 36.0, 95% CI - 384.5 to 19.1) compared with OT. IVA indicated that BRBC had a survival benefit over OT in the 1-year, 3-year, and 5-year of 1.5% (95% CI 1.2-1.9%), 0.7% (95% CI 0.6-0.8%), and 2.6% (95% CI 2.0-3.4%), respectively.
CONCLUSION


Adjuvant SEGT cannot significantly prolong 5-year survival in breast cancer, though a longer observation period is warranted according to the marginal survival benefit identified at the end of the follow-up.",2020,"BRBC was not significantly associated with improved 1-year (HR 0.74, 95% CI 0.49-1.10, P = 0.1748; NNT = 44.8, 95% CI - 118.5 to 22.6), 3-year (HR 0.98, 95% CI 0.75-1.27, P = 0.8640; NNT = 273.7, 95% CI - 21.0 to 21.3), or 5-year survival (HR 0.79, 95% CI 0.61-1.02, P = 0.0908; NNT = 36.0, 95% CI - 384.5 to 19.1) compared with OT.","['breast cancer', '3327 patients with breast cancer']","['adjuvant supportive-expressive group therapy', 'oncologic treatment combined with SEGT-based intervention (referred to as BRBC [n\u2009=\u2009354]) and those who only received oncologic treatment', 'adjuvant supportive-expressive group therapy (SEGT']","['5-year survival', 'overall survival (OS) at 1-year, 3-year, 5-year', 'median overall survival', 'survival benefit', 'BRBC']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3327.0,0.362167,"BRBC was not significantly associated with improved 1-year (HR 0.74, 95% CI 0.49-1.10, P = 0.1748; NNT = 44.8, 95% CI - 118.5 to 22.6), 3-year (HR 0.98, 95% CI 0.75-1.27, P = 0.8640; NNT = 273.7, 95% CI - 21.0 to 21.3), or 5-year survival (HR 0.79, 95% CI 0.61-1.02, P = 0.0908; NNT = 36.0, 95% CI - 384.5 to 19.1) compared with OT.","[{'ForeName': 'Zeng Jie', 'Initials': 'ZJ', 'LastName': 'Ye', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China. zengjieye@qq.com.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, Guangdong Province, China.'}, {'ForeName': 'Xiao Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, 510275, Guangdong Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Institute of Tumor, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Guangdong Provincial Key Laboratory of New Drug Development and Research of Chinese Medicine, Mathematical Engineering Academy of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.'}, {'ForeName': 'Mu Zi', 'Initials': 'MZ', 'LastName': 'Liang', 'Affiliation': 'Guangdong Academy of Population Development, Guangzhou, 510600, Guangdong Province, China.'}, {'ForeName': 'Yuan Liang', 'Initials': 'YL', 'LastName': 'Yu', 'Affiliation': 'South China University of Technology, Guangzhou, 510641, Guangdong Province, China.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05526-4']
1766,31992840,Adult T-cell acute lymphoblastic leukemias with IL7R pathway mutations are slow-responders who do not benefit from allogeneic stem-cell transplantation.,"The prognostic value of IL7-receptor pathway (IL7Rp) mutations in T-cell acute lymphoblastic leukemia (T-ALL) remains unclear. We performed a comprehensive study of 200 adult patients with T-ALL included in the GRAALL2003/2005 protocols to address the clinical significance of IL7Rp mutations. Next-generation sequencing of the IL7Rp (IL7R/JAK1/JAK3/STAT5B) revealed that IL7Rp mutations were frequent in adult T-ALL (28%) particularly in immature/early T-cell progenitor (ETP)-ALL. They were associated with mutations of NOTCH-pathway, PHF6, and PRC2 components but not with K/NRAS. IL7Rp mutated (IL7Rp mut ) T-ALL were slow-responders, with a high rate of M2/M3 day-8 marrow compared with IL7Rp non-mutated (IL7Rp WT ) T-ALL (p = 0.002) and minimal residual disease positivity at 6-weeks (MRD1) (p = 0.008) but no difference in MRD2 positivity at 12-weeks. Despite this, no adverse prognosis was evidenced when censored for allogeneic hematopoietic stem cell transplantation (HSCT). In time-dependent analysis, HSCT did not benefit IL7Rp mut  patients whereas it was of marked benefit to IL7Rp WT  cases. IL7Rp-mutations identify a subgroup of slow-responder T-ALLs which benefit from post-induction chemotherapy regimens but not from HSCT. Our data suggest that prior knowledge of the mutation status of IL7Rp may influence HSCT decision and help to guide therapy reduction.",2020,"In time-dependent analysis, HSCT did not benefit IL7Rp mut  patients whereas it was of marked benefit to IL7Rp WT  cases.","['Adult T-cell acute lymphoblastic leukemias with IL7R', '200 adult patients with T-ALL included in the GRAALL2003/2005 protocols to address the clinical significance of IL7Rp mutations']",['IL7Rp (IL7R/JAK1/JAK3/STAT5B'],"['IL7Rp mutated (IL7Rp mut ) T-ALL', 'MRD2 positivity', 'minimal residual disease positivity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961099', 'cui_str': 'T-cell acute lymphoblastic leukemia'}, {'cui': 'C0083032', 'cui_str': 'Interleukin-7 receptor'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0083032', 'cui_str': 'Interleukin-7 receptor'}]","[{'cui': 'C0083032', 'cui_str': 'Interleukin-7 receptor'}, {'cui': 'C1961099', 'cui_str': 'T-cell acute lymphoblastic leukemia'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",200.0,0.0260408,"In time-dependent analysis, HSCT did not benefit IL7Rp mut  patients whereas it was of marked benefit to IL7Rp WT  cases.","[{'ForeName': 'Rathana', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Boissel', 'Affiliation': 'Université de Paris, EA-3518, Institut de Recherche Saint-Louis, Hematology Adolescent and Young Adult Unit, Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Touzart', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Leguay', 'Affiliation': 'Department of Hematology, CHU de Bordeaux, Hôpital du Haut-Levêque, Pessac, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Thonier', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'Department of Hematology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Bénite, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Raffoux', 'Affiliation': 'Université de Paris, Department of Hematology, Adult Hematology Unit, Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': ""Service d'Hématologie, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Villarese', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Fourrage', 'Affiliation': 'Plateforme Bioinformatique, Institut Imagine, Paris, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Passini', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Hunault', 'Affiliation': 'Department of Hematology, CHU Angers, Angers, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Lepretre', 'Affiliation': 'Inserm U1245 and Department of Hematology, Centre Henri Becquerel and Normandie Univ UNIROUEN, Rouen, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Chevallier', 'Affiliation': 'Department of Hematology, CHU, Nantes, France.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': ""Institut Universitaire d'Hématologie, Université Paris Diderot, Sorbonne Paris Cité, Paris Cancer Research Institute (PACRI), Paris, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Lhéritier', 'Affiliation': 'Group for Research on Adult Acute Lymphoblastic Leukemia, Coordination Office, Centre Hospitalier Lyon Sud, Pierre Bénite, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Chantepie', 'Affiliation': ""Institut d'Hématologie de Basse-Normandie, CHU, Caen, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Maury', 'Affiliation': ""Service d'Hématologie, Assistance Publique, Hôpitaux de Paris, Hôpital Henri Mondor, Créteil, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Escoffre', 'Affiliation': ""Service d'Hématologie Clinique, CHU, Hôpital Pontchaillou, Rennes, France.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': ""Service d'Hématologie, Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Department of Oncology, Department of Medical Specialties, University Hospital and University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Graux', 'Affiliation': ""Université Catholique de Louvain, Service d'Hématologie, CHU UCL Namur-Godinne, Yvoir, Belgique.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': 'Department of Hematology, CHU Angers, Angers, France.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Asnafi', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': 'Université de Paris, Department of Hematology, Adult Hematology Unit, Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lhermitte', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France. ludovic.lhermitte@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-019-0685-4']
1767,31273244,Vasopressin enhances human preemptive strike in both males and females.,"The neuropeptide arginine vasopressin (AVP), which is known to modulate a wide range of social behaviors in animals, has been identified as a modulator of various negative responses to social stimuli in humans. However, behavioral evidence directly supporting its involvement in human defensive aggression has been rare. We investigated the effect of intranasal AVP on defensive aggression in a laboratory experiment, using an incentivized economic game called the ""preemptive strike game"" (PSG). Participants played PSG individually (1 on 1) as well as in pairs (2 on 2) under either AVP or saline. We observed that exogenous but not basal AVP modulated the attack rate in PSG for both male and female participants. A model-based analysis of the aggregation of individual attack preferences into pair decisions revealed that the AVP effect on defensive aggression occurred mainly at the individual level and was not amplified at the pair level. Overall, these results present the first evidence that intranasal AVP promotes human defensive aggression for both males and females in a bilateral situation where each party can potentially damage the resources of the other party. These findings also parallel accumulating evidence from non-human animals concerning AVP's involvement in territorial defense against potential intruders.",2019,A model-based analysis of the aggregation of individual attack preferences into pair decisions revealed that the AVP effect on defensive aggression occurred mainly at the individual level and was not amplified at the pair level.,['male and female participants'],"['Vasopressin', 'neuropeptide arginine vasopressin (AVP', 'AVP or saline', 'intranasal AVP']","['defensive aggression', 'attack rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0233525', 'cui_str': 'Defensive aggression'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0367947,A model-based analysis of the aggregation of individual attack preferences into pair decisions revealed that the AVP effect on defensive aggression occurred mainly at the individual level and was not amplified at the pair level.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawada', 'Affiliation': 'Department of Social Psychology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Nagasawa', 'Affiliation': 'Department of Animal Science and Biotechnology, Azabu University, Kanagawa, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Murata', 'Affiliation': 'NTT Communication Science Laboratories, NTT Corporation, Kanagawa, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Mogi', 'Affiliation': 'Department of Animal Science and Biotechnology, Azabu University, Kanagawa, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, Tokyo, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Kikusui', 'Affiliation': 'Department of Animal Science and Biotechnology, Azabu University, Kanagawa, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Kameda', 'Affiliation': 'Department of Social Psychology, The University of Tokyo, Tokyo, Japan. tkameda@l.u-tokyo.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-45953-y']
1768,31289281,The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.,"Cefaly (Cefaly Technology, Seraing, Belgium) is a device that stimulates the bilateral supraorbital nerve transcutaneously. A previous study in Europe proved that Cefaly was an effective and safe device as a preventive therapy for migraine. However, there have been no studies on this device in Asia. We examined the safety and preventive effect of Cefaly for migraine. One-hundred patients were prospectively collected from four headache units in Japan. The inclusion criteria were as follows: 18-75 years of age, migraine with and without aura, and at least 2 attacks per month. A 4-week baseline period was followed by 12-week treatment period. The primary end point was the change from baseline in the number of migraine days at 12 weeks. The secondary end points include the changes of the number of migraine attacks, all headache days, acute medicine consumption days and headache severity. After treatment, a questionnaire survey on the satisfaction of the treatment was administered to the patients. The Friedmann test was used to assess the changes between baseline period and after treatment, and Mann-Whitney U test was used for the comparison of efficacy between chronic migraine and episodic migraine, with and without prophylactic treatment or medication overuse. After 12 weeks of treatment, Cefaly use significantly decreased the number of migraine days (8.16 vs. 6.84; p = 0.0036). Only three subjects (3.0%) dropped out due to the adverse effects; however, no serious adverse events were observed. The compliance of this study was very high at 90.0%. Furthermore, a significant decrease was observed in the number of migraine attacks (5.33 vs. 3.94; p = 0.0002) and the intake of acute antimigraine drugs (8.75 vs. 7.83; p = 0.0166). Cefaly is considered to be a safe and highly tolerable effective device for Japanese patients. Trial registration: This study was retrospectively registered to UMIN-CTR(UMIN000033333) on 10 July 2018.",2019,"Only three subjects (3.0%) dropped out due to the adverse effects; however, no serious adverse events were observed.","['The inclusion criteria were as follows: 18-75 years of age, migraine with and without aura, and at least 2 attacks per month', 'One-hundred patients were prospectively collected from four headache units in Japan', 'Japanese patients', 'Japanese migraine patients']",['supraorbital transcutaneous stimulator'],"['intake of acute antimigraine drugs', 'number of migraine days', 'changes of the number of migraine attacks, all headache days, acute medicine consumption days and headache severity', 'number of migraine attacks']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0175727', 'cui_str': 'Stimulator'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",100.0,0.0280207,"Only three subjects (3.0%) dropped out due to the adverse effects; however, no serious adverse events were observed.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Danno', 'Affiliation': 'Department of Neurology, Headache Center, Tominaga Hospital, 1-4-48 Minatomachi Naniwa-ku, Osaka-shi, Osaka, 556-0017, Japan. daisukedanno@yahoo.co.jp.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Iigaya', 'Affiliation': 'Department of Neurology, Kitasato University, Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Imai', 'Affiliation': 'Department of Neurology, Japanese Red Cross Shizuoka Hospital, 8-2 Ohtemachi, Aoi-ku, Shizuoka, 420-0853, Japan.'}, {'ForeName': 'Hisaka', 'Initials': 'H', 'LastName': 'Igarashi', 'Affiliation': 'Headache Care Unit, Department of Internal Medicine, Fujitsu Clinic, 4-1-1 Kamikodanaka, Nakahara-ku, Kawasaki, Kanagawa, 211-8588, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takeshima', 'Affiliation': 'Department of Neurology, Headache Center, Tominaga Hospital, 1-4-48 Minatomachi Naniwa-ku, Osaka-shi, Osaka, 556-0017, Japan.'}]",Scientific reports,['10.1038/s41598-019-46044-8']
1769,33105360,"Influence of Resistance Training Exercise Order on Muscle Strength, Hypertrophy, and Anabolic Hormones in Older Women: A Randomized Controlled Trial.","Tomeleri, CM, Ribeiro, AS, Nunes, JP, Schoenfeld, BJ, Souza, MF, Schiavoni, D, Junior, PS, Cavaglieri, CR, Cunha, PM, Venturini, D, Barbosa, DS, and Cyrino, ES. Influence of resistance training exercise order on muscle strength, hypertrophy, and anabolic hormones in older women: a randomized controlled trial. J Strength Cond Res 34(11): 3103-3109, 2020-The purpose of this study was to analyze the effects of resistance training (RT) exercise order on muscle strength, hypertrophy, and anabolic hormones in older women. Forty-four older women were randomly assigned to 1 of 3 groups: a nonexercise control group (CON, n = 15) and two RT groups that performed a 12-week RT program in a multijoint to single-joint order (MJ-SJ, n = 14), or in a single-joint to multijoint order (SJ-MJ, n = 15). The RT protocol (3×/week) encompassed 8 exercises, with 3 sets of 10-15 repetitions performed per exercise. One repetition maximum tests were used to evaluate muscle strength; dual-energy X-ray absorptiometry was used to estimate lean soft tissue. Both training groups showed significant and similar increases in muscle strength (MJ-SJ = 16.4%; SJ-MJ = 12.7%) and mass (MJ-SJ = 7.5%; SJ-MJ = 6.1%), whereas there were no significant changes in testosterone and insulin-like growth factor 1. The results suggest that both approaches are similarly effective in eliciting morphofunctional improvements in older women.",2020,"Both training groups showed significant and similar increases in muscle strength (MJ-SJ = 16.4%; SJ-MJ = 12.7%) and mass (MJ-SJ = 7.5%; SJ-MJ = 6.1%), whereas there were no significant changes in testosterone and insulin-like growth factor 1.","['older women', 'Older Women', 'J Strength Cond Res 34(11', 'Forty-four older women']","['Resistance Training Exercise', 'resistance training (RT) exercise', 'resistance training exercise', 'nonexercise control group (CON, n = 15) and two RT groups that performed a 12-week RT program']","['testosterone and insulin-like growth factor 1', 'muscle strength', 'Muscle Strength, Hypertrophy, and Anabolic Hormones', 'muscle strength, hypertrophy, and anabolic hormones', 'Tomeleri, CM, Ribeiro, AS, Nunes, JP, Schoenfeld, BJ, Souza, MF, Schiavoni, D, Junior, PS, Cavaglieri, CR, Cunha, PM, Venturini, D, Barbosa, DS, and Cyrino, ES']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",44.0,0.0166265,"Both training groups showed significant and similar increases in muscle strength (MJ-SJ = 16.4%; SJ-MJ = 12.7%) and mass (MJ-SJ = 7.5%; SJ-MJ = 6.1%), whereas there were no significant changes in testosterone and insulin-like growth factor 1.","[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Exercise Science Department, Cuny Lehman College, Bronx, New York.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil.'}, {'ForeName': 'Durcelina', 'Initials': 'D', 'LastName': 'Schiavoni', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Paulo S', 'Initials': 'PS', 'LastName': 'Junior', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Cláudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Faculty of Physical Education, University of Campinas-Unicamp, Campinas, Brazil.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003147']
1770,33105361,The Effect of Augmented Feedback Type and Frequency on Velocity-Based Training-Induced Adaptation and Retention.,"Nagata, A, Doma, K, Yamashita, D, Hasegawa, H, and Mori, S. The effect of augmented feedback type and frequency on velocity-based training-induced adaptation and retention. J Strength Cond Res 34(11): 3110-3117, 2020-The purpose of this study was to compare the benefits of 4 weeks of velocity-based training (VBT) using different augmented feedback (AugFb) types and the frequency of AugFb, and whether adaptations are retained 10 days post-training. Thirty-seven collegiate male rugby players were divided into groups that received immediate feedback (ImFb; n = 9), visual feedback (ViFb; n = 10), average feedback (AvgFb; n = 10) and no feedback (NoFb; n = 8) during each VBT session consisting of 3 sets of 5 repetitions of loaded jump squats. The ImFb group received AugFb regarding lifting velocity under loaded jump squats (LV-JS) after every jump, whereas LV-JS measures were averaged after each set of jumps and presented to the AvgFb group. The LV-JS were video-recorded and displayed as kinematic feedback for the ViFb group after each set, although NoFb was provided for the NoFb group. Loaded jump squats measures were reported at baseline, during each training session and 10 days post-training. Loaded jump squats measures were significantly greater for the ImFb Group compared with the other groups during a number of post-baseline time points (p ≤ 0.05). Furthermore, at 4 weeks of VBT and 10 days post-retention, effect size (ES) calculations showed that LV-JS measures were greater with moderate to large effects for the ImFb group compared with the NoFb (ES = 1.02-1.25), AvgFb (ES = 0.78-0.82) and ViFb (ES = 0.74-1.60), respectively. However, LV-JS measures were reduced with moderate to large effects 10 days post-retention for the ViFb (ES = -0.60) and NoFb (ES = -0.85) groups. Providing LV-JS feedback after each jump appears to optimize performance and should be considered as a training tool during VBT.",2020,Loaded jump squats measures were significantly greater for the ImFb Group compared with the other groups during a number of post-baseline time points (p ≤ 0.05).,"['J Strength Cond Res 34(11', 'Thirty-seven collegiate male rugby players']","['immediate feedback (ImFb; n = 9), visual feedback (ViFb; n = 10), average feedback (AvgFb; n = 10) and no feedback (NoFb; n = 8) during each VBT session consisting of 3 sets of 5 repetitions of loaded jump squats', 'velocity-based training (VBT']","['kinematic feedback', 'Loaded jump squats measures', 'Nagata, A, Doma, K, Yamashita, D, Hasegawa, H, and Mori, S']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",37.0,0.0395464,Loaded jump squats measures were significantly greater for the ImFb Group compared with the other groups during a number of post-baseline time points (p ≤ 0.05).,"[{'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Nagata', 'Affiliation': 'Faculty of Sports Science, Chukyo University, Aichi, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Yamashita', 'Affiliation': 'Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Faculty of Sports Science, Ryukoku University, Kyoto, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Faculty of Information Science and Electrical Engineering Kyushu University, Fukuoka, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002514']
1771,33105368,Effects of Probiotic (Bacillus subtilis) Supplementation During Offseason Resistance Training in Female Division I Athletes.,"Toohey, JC, Townsend, JR, Johnson, SB, Toy, AM, Vantrease, WC, Bender, D, Crimi, CC, Stowers, KL, Ruiz, MD, VanDusseldorp, TA, Feito, Y, and Mangine, GT. Effects of probiotic (Bacillus subtilis) supplementation during offseason resistance training in female Division I athletes. J Strength Cond Res 34(11): 3173-3181, 2020-We examined the effects of probiotic (Bacillus subtilis) supplementation during offseason training in collegiate athletes. Twenty-three Division I female athletes (19.6 ± 1.0 years, 67.5 ± 7.4 kg, and 170.6 ± 6.8 cm) participated in this study and were randomized into either a probiotic (n = 11; DE111) or placebo (n = 12; PL) group while counterbalancing groups for sport. Athletes completed a 10-week resistance training program during the offseason, which consisted of 3-4 workouts per week of upper- and lower-body exercises and sport-specific training. Athletes consumed DE111 (DE111; 5 billion CFU/day) or PL supplement daily for the entire 10-week program. Before and after training, all athletes underwent 1 repetition maximum (1RM) strength testing (squat, deadlift, and bench press), performance testing (vertical jump and pro-agility), and isometric midthigh pull testing. Body composition (body fat [BF]%) was completed using BODPOD and bioelectrical impedance analysis, as well as muscle thickness (MT) measurement of the rectus femoris (RF) and vastus lateralis using ultrasonography. Separate repeated-measures analyses of variance were used to analyze all data. Significant (p ≤ 0.05) main effects for time were observed for improved squat 1RM, deadlift 1RM, bench press 1RM, vertical jump, RF MT, and BF%. Of these, a significant group × time interaction was noted for BF% (p = 0.015), where greater reductions were observed in DE111 (-2.05 ± 1.38%) compared with PL (-0.2 ± 1.6%). No other group differences were observed. These data suggest that probiotic consumption in conjunction with post-workout nutrition had no effect on physical performance but may improve body composition in female Division I soccer and volleyball players after offseason training.",2020,"Significant (p ≤ 0.05) main effects for time were observed for improved squat 1RM, deadlift 1RM, bench press 1RM, vertical jump, RF MT, and BF%.","['I female athletes (19.6 ± 1.0 years, 67.5 ± 7.4 kg, and 170.6 ± 6.8 cm', 'Female Division', 'Twenty-three Division', 'female Division I athletes', 'J Strength Cond Res 34(11', 'collegiate athletes', 'female Division', 'I soccer and volleyball players after offseason training']","['resistance training program during the offseason, which consisted of 3-4 workouts per week of upper- and lower-body exercises and sport-specific training', 'Probiotic (Bacillus subtilis) Supplementation', 'repetition maximum (1RM) strength testing (squat, deadlift, and bench press), performance testing (vertical jump and pro-agility), and isometric midthigh pull testing', 'placebo', 'probiotic', 'probiotic (Bacillus subtilis) supplementation']","['muscle thickness (MT) measurement of the rectus femoris (RF) and vastus lateralis using ultrasonography', 'Body composition (body fat [BF', 'squat 1RM, deadlift 1RM, bench press 1RM, vertical jump, RF MT, and BF', 'physical performance', 'body composition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0288047,"Significant (p ≤ 0.05) main effects for time were observed for improved squat 1RM, deadlift 1RM, bench press 1RM, vertical jump, RF MT, and BF%.","[{'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Toohey', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Townsend', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Sean B', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Toy', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Vantrease', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bender', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Chelsea C', 'Initials': 'CC', 'LastName': 'Crimi', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Stowers', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Ruiz', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, Kennesaw, Georgia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Feito', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, Kennesaw, Georgia.'}, {'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, Kennesaw, Georgia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002675']
1772,33105371,Optimizing Intersession Reliability of Heart Rate Variability-The Effects of Artifact Correction and Breathing Type.,"Gisselman, AS, D'Amico, M, and Smoliga, JM. Optimizing intersession reliability of heart rate variability-the effects of artifact correction and breathing type. J Strength Cond Res 34(11): 3199-3207, 2020-This study aimed to comprehensively investigate the reliability of multiple heart rate variability (HRV) parameters and to explore the influence of artifact removal and breathing condition on HRV reliability. Resting HRV was collected using Polar Team monitors on 41 participants (age: 19.9 ± 1.2 years; 28 females and 13 males) during 2 separate days. Within each session, participants performed 10 minutes each of spontaneous and controlled breathing (randomized order). Kubios HRV analysis software was used to analyze 180-second data epochs using ""low"" or ""strong"" artifact removal. Relative reliability was assessed using intraclass correlation coefficient (ICC2,1), and absolute reliability was quantified using mean-normalized SEM%. Time-domain and nonlinear parameters produced poor to good intersession agreement (ICC = 0.34-0.68; SEM% = 11.0-39.0) with ""low"" artifact removal, regardless of breathing condition. Frequency-domain parameters demonstrated fair intersession agreement during controlled breathing (ICC = 0.40-0.45; SEM% = 26.0-70.0) but poor agreement during spontaneous breathing (ICC = 0.07-0.13; SEM% = 32.0-81.0). Minimal differences in ICCs were observed between ""low"" and ""strong"" artifact removal. Thus, this study provides 3 practical applications: (a) HRV monitoring is most reliable when using time-domain and nonlinear parameters, regardless of breathing or filtering condition, but no single parameter is especially reliable. The large variation and poor intersession reliability of frequency indices during spontaneous breathing are improved by controlling breathing rate; (b) ""Low"" artifact removal seems superior to more aggressive artifact removal; and (c) intersession differences in HRV measurements <30% may be indicative of normal daily variation rather than true physiologic changes.",2020,"Time-domain and nonlinear parameters produced poor to good intersession agreement (ICC = 0.34-0.68; SEM% = 11.0-39.0) with ""low"" artifact removal, regardless of breathing condition.","['41 participants (age: 19.9 ± 1.2 years; 28 females and 13 males) during 2 separate days', 'J Strength Cond Res 34(11']","['Artifact Correction and Breathing Type', 'artifact correction and breathing type']","[""Gisselman, AS, D'Amico, M, and Smoliga, JM"", 'ICCs', 'Optimizing Intersession Reliability of Heart Rate Variability', 'reliability of multiple heart rate variability (HRV) parameters', 'HRV reliability', 'intraclass correlation coefficient (ICC2,1), and absolute reliability']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",41.0,0.0176554,"Time-domain and nonlinear parameters produced poor to good intersession agreement (ICC = 0.34-0.68; SEM% = 11.0-39.0) with ""low"" artifact removal, regardless of breathing condition.","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Gisselman', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DʼAmico', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Smoliga', 'Affiliation': 'Physical Therapy, High Point University, High Point, North Carolina.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002258']
1773,33105376,Short-Term Plyometric Jump Training Improves Repeated-Sprint Ability in Prepuberal Male Soccer Players.,"Negra, Y, Chaabene, H, Fernandez-Fernandez, J, Sammoud, S, Bouguezzi, R, Prieske, O, and Granacher, U. Short-term plyometric jump training improves repeated-sprint ability in prepuberal male soccer players. J Strength Cond Res 34(11): 3241-3249, 2020-This study examined the effects of a short-term (i.e., 8 weeks) combined horizontal and vertical plyometric jump training (PJT) program in combination with regular soccer-specific training as compared with soccer-specific training only on jump and change of direction (CoD) performances, speed, and repeated-sprint ability (RSA) in prepuberal male soccer players. Twenty-four players were recruited and randomly assigned to either a PJT group (PJTG; n = 13; 12.7 ± 0.2 years) or an active control group (CONG; n = 11; 12.7 ± 0.2 years). The outcome measures included tests for the assessment of jump performance (drop jump from 20- to 40-cm height [DJ20 and DJ40] and 3-hop test [THT]), speed (20-m sprint), CoD (T-test), and RSA (20-m repeated shuttle sprint). Data were analyzed using magnitude-based inferences. Within-group analyses revealed large performance improvements in the T-test (d = -1.2), DJ20 (d = 3.7), DJ40 (d = 3.6), THT (d = 0.6), and the RSAtotal (d = -1.6) in the PJTG. Between-group analyses showed greater performance improvements in the T-test (d = -2.9), 20-m sprint time (d = -2.0), DJ20 (d = 2.4), DJ40 (d = 2.0), THT (d = 1.9), RSAbest (d = -1.9), and the RSAtotal (d = -1.9) in the PJTG compared with CONG. Eight weeks of an in-season PJT in addition to regular soccer-specific training induced larger increases in measures of physical fitness in prepuberal male soccer players compared with regular soccer-specific training only. More specifically, PJT was effective in improving RSA performance.",2020,"Between-group analyses showed greater performance improvements in the T-test (d = -2.9), 20-m sprint time (d = -2.0), DJ20 (d = 2.4), DJ40 (d = 2.0), THT (d = 1.9), RSAbest (d = -1.9), and the RSAtotal (d = -1.9) in the PJTG compared with CONG.","['J Strength Cond Res 34(11', 'prepuberal male soccer players', 'Twenty-four players', 'Prepuberal Male Soccer Players']","['PJT', 'plyometric jump training', 'combined horizontal and vertical plyometric jump training (PJT) program in combination with regular soccer-specific training as compared with soccer-specific training only on jump and change of direction (CoD) performances, speed, and repeated-sprint ability (RSA', 'Short-Term Plyometric Jump Training']","['20-m sprint time', 'performance improvements', 'physical fitness', 'jump performance (drop jump from 20- to 40-cm height [DJ20 and DJ40] and 3-hop test [THT]), speed (20-m sprint), CoD (T-test), and RSA (20-m repeated shuttle sprint', 'RSA performance', 'large performance improvements']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",24.0,0.0179498,"Between-group analyses showed greater performance improvements in the T-test (d = -2.9), 20-m sprint time (d = -2.0), DJ20 (d = 2.4), DJ40 (d = 2.0), THT (d = 1.9), RSAbest (d = -1.9), and the RSAtotal (d = -1.9) in the PJTG compared with CONG.","[{'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance, Health & Society,"" Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fernandez-Fernandez', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Physical Activity and Sports Sciences, University of Leon, Leon, Spain.'}, {'ForeName': 'Senda', 'Initials': 'S', 'LastName': 'Sammoud', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance, Health & Society,"" Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance, Health & Society,"" Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prieske', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002703']
1774,33105418,Assessment of High Flow Nasal Cannula Oxygenation in Endobronchial Ultrasound Bronchoscopy: A Randomized Controlled Trial.,"BACKGROUND


Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been widely implemented in evaluating mediastinal disease. EBUS-TBNA is performed with low flow oxygen systems or general anesthesia. Little data exist on use of high flow nasal cannula (HFNC) in EBUS-TBNA.
METHODS


This was a single center parallel group randomized controlled trial comparing oxygenation through HFNC (Optiflow) against nasal prongs during EBUS. The primary end-point was the drop in oxygen saturations from procedure commencement, recorded by pulse oximetry, to the lowest level during EBUS-TBNA. Secondary end-points included changes in venous blood carbon dioxide, lowest oxygen saturation, changes in end-tidal CO2 during the procedure, intubation within 8 hours of the procedure and patient experience reported on a visual analog scale.
RESULTS


We randomized 20 patients to each study arm. The primary outcome of oxygen desaturation during the procedure was statistically significant with a difference of 7.7 percentage points (95% confidence interval, 4.91-10.49, P<0.001). The secondary outcome measure of lowest oxygen saturation was also statistically significant with a difference of -9.2 (95% confidence interval, -11.96 to -6.44, P<0.001). There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
CONCLUSION


This single institution study in a university, tertiary referral center confirms that EBUS-TBNA performed with HFNC is associated with a statistically significant lower drop in oxygen saturation. Additional studies are needed to assess if this translates into improved clinical outcomes postprocedure.",2020,"There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
",['Endobronchial Ultrasound Bronchoscopy'],"['oxygenation through HFNC (Optiflow', 'Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'High Flow Nasal Cannula Oxygenation', 'high flow nasal cannula (HFNC']","['drop in oxygen saturations', 'oxygen saturation', 'safety outcomes, visual analog scale score', 'lowest oxygen saturation', 'oxygen desaturation', 'changes in venous blood carbon dioxide, lowest oxygen saturation, changes in end-tidal CO2 during the procedure, intubation within 8 hours of the procedure and patient experience reported on a visual analog scale']","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",20.0,0.486921,"There was no difference in safety outcomes, visual analog scale score or in their willingness to return for repeat procedure.
","[{'ForeName': 'Mujammil', 'Initials': 'M', 'LastName': 'Irfan', 'Affiliation': 'Interventional Respiratory Unit, Galway University Hospital, Newcastle Road, Galway, Ireland.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'The Chest Centre, Aintree University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Breen', 'Affiliation': 'Interventional Respiratory Unit, Galway University Hospital, Newcastle Road, Galway, Ireland.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000719']
1775,33105455,Can upstream patient education improve fracture care in a digital world? Use of a decision aid for the treatment of displaced diaphyseal clavicle fractures.,"BACKGROUND


The increasing proportion of telemedicine and virtual care in orthopaedic surgery presents an opportunity for upstream delivery of patient facing tools, such as decision aids. Displaced diaphyseal clavicle fractures (DDCF) are ideal for a targeted intervention as there is no superior treatment, and decisions are often dependent on patient preference. A decision aid provided prior to consultation may educate a patient and minimize decisional conflict similarly to in-person consultation with an orthopaedic traumatologist.
METHODS


Patients with DDCF were enrolled into two groups. The usual care group participated in a discussion with a trauma fellowship trained orthopaedic surgeon. Patients in the intervention group were administered a DDCF decision aid designed with International Patient Decision Aid Standards. Primary comparisons were made based on decisional conflict score. Secondary outcomes included treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance.
RESULTS


A total of 41 patients enrolled. Decisional conflict scores were similar and low between the two groups: 11.8 (usual care) and 11.4 (decision aid). There were no differences in secondary outcomes between usual care and the decision aid.
DISCUSSION


Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon. This decision aid could be a useful resource for surgeons who infrequently treat this injury or whose practices are shifting toward telemedicine visits. Providing a decision aid prior to consultation may help incorporate patient values and preferences into the decision-making process between surgery and non-operative management.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"['Patients with DDCF were enrolled into two groups', 'displaced diaphyseal clavicle fractures', '41 patients enrolled', 'Displaced diaphyseal clavicle fractures (DDCF']","['usual care group participated in a discussion with a trauma fellowship trained orthopaedic surgeon', 'DDCF decision aid designed with International Patient Decision Aid Standards']","['decisional conflict score', 'Decisional conflict scores', 'treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",41.0,0.0517422,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"[{'ForeName': 'Cara H', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Van Rysselberghe', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Geoffrey D', 'Initials': 'GD', 'LastName': 'Abrams', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gardner', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001916']
1776,33105582,"The Effect of a 13-Valent Conjugate Pneumococcal Vaccine on Circulating Antibodies Against Oxidized LDL and Phosphorylcholine in Man, A Randomized Placebo-Controlled Clinical Trial.","In mice vaccination with  Streptococcus pneumoniae  results in an increase in anti-oxLDL IgM antibodies due to mimicry of anti-phosphorylcholine (present in the cell wall of  S. pneumoniae ) and anti-oxLDL IgM. In this study we investigated the human translation of this molecular mimicry by vaccination against  S. pneumoniae  using the Prevenar-13 vaccine. Twenty-four healthy male volunteers were vaccinated with Prevenar-13, either three times, twice or once in a double-blind, placebo-controlled, randomized single center clinical study. Anti-pneumococcal wall, oxLDL and phosphorycholine antibody levels were measured at a fixed serum dilution, as well as circulating lipid levels over the course of 68 weeks. A significant increase in anti-oxLDL IgG and IgM was seen in the group receiving two doses six months apart compared to the placebo. However, these differences were not observed in the groups receiving a single dose, two doses one month apart, or three doses. This study shows that vaccination with Prevenar-13 does not result in robust anti-oxLDL IgM levels in humans. Further research would be required to test alternative pneumococcal-based vaccines, vaccination regimens or study populations, such as cardiovascular disease patients.",2020,A significant increase in anti-oxLDL IgG and IgM was seen in the group receiving two doses six months apart compared to the placebo.,"['Twenty-four healthy male volunteers', 'Man']","['13-Valent Conjugate Pneumococcal Vaccine', 'Placebo', 'placebo']","['anti-oxLDL IgG and IgM', 'circulating lipid levels', 'anti-oxLDL IgM antibodies']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",24.0,0.130633,A significant increase in anti-oxLDL IgG and IgM was seen in the group receiving two doses six months apart compared to the placebo.,"[{'ForeName': 'Hendrika W', 'Initials': 'HW', 'LastName': 'Grievink', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ozsvar Kozma', 'Affiliation': 'Department of Laboratory Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Kuiper', 'Affiliation': 'Division of BioTherapeutics, Leiden Academic Center for Drug Research, Leiden University, Einsteinweg 55, 2333 CC Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Binder', 'Affiliation': 'Department of Laboratory Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands.'}]",Biology,['10.3390/biology9110345']
1777,33105594,"Diode versus CO 2  Laser Therapy in the Treatment of High Labial Frenulum Attachment: A Pilot Randomized, Double-Blinded Clinical Trial.","Background:  The labial frenula are triangular plicas departing from the alveolar mucosa and attaching themselves at different heights of the gingiva. Sometimes a high attachment can determine a gingival recession. The most suitable surgical resolution is the use of laser devices. The aim of this study was to compare the labial frenulectomy through the use of Diode and CO 2  laser techniques in pediatric patients with a high labial frenulum attachment, clarifying at the same time the preventive role of the surgical treatment to avoid further recession.  Methods:  A pilot randomized, double-blinded clinical trial was conducted to compare both the surgical advantages and the preventive treatment of laser technology using two different wavelengths within a population of pediatric patients with a high labial frenulum attachment. Different parameters intra and post-surgery were taken into account (Bleeding, Wound Healing, Gingival Recession, Periodontal pocket and Numerical Scale Value for pain) to compare Diode versus CO 2  laser therapy.  Results:  Although both the laser devices provide a good performance in the post-operative period, the Diode laser shows better results ( p  < 0.001) in three of the five parameters evaluated.  Conclusions:  From the results it was found that the Diode Laser device is more suitable compared to the CO 2  device.",2020,"Although both the laser devices provide a good performance in the post-operative period, the Diode laser shows better results ( p  < 0.001) in three of the five parameters evaluated.  ","['High Labial Frenulum Attachment', 'pediatric patients with a high labial frenulum attachment']","['Diode Laser device', 'laser technology', 'Diode versus CO 2  Laser Therapy', 'Diode and CO 2  laser techniques']","['account (Bleeding, Wound Healing, Gingival Recession, Periodontal pocket and Numerical Scale Value for pain']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022861', 'cui_str': 'Structure of frenulum labii'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.115686,"Although both the laser devices provide a good performance in the post-operative period, the Diode laser shows better results ( p  < 0.001) in three of the five parameters evaluated.  ","[{'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Sfasciotti', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zara', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Iole', 'Initials': 'I', 'LastName': 'Vozza', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Carocci', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Ierardo', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Polimeni', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17217708']
1778,33109037,A randomized study on the bioequivalence of desloratadine in Chinese healthy subjects and the association of different metabolic phenotypes with UGT2B10 and CYP2C8 genotypes.,"BACKGROUND


Desloratadine is a drug with a phenotypic polymorphism in metabolism and has been approved for use in many countries to treat allergic diseases. CYP2C8 and UGT2B10 are metabolic enzymes, which may be involved in the metabolism of desloratadine.
OBJECTIVE


This study was aimed to demonstrate bioequivalence between the test product (desloratadine tablet) and reference product AERIUS (5mg) both orally. And we directly examine the role of UGT2B10 and CYP2C8 genotypes in Chinese healthy subjects with different Desloratadine metabolic phenotypes.
METHODS


It was a randomized, open-label, and four-sequence, single-dose crossover study conducted on 56 Chinese healthy subjects. The pharmacokinetics (PK) and safety of the test and reference Desloratadine products were compared. UGT2B10 and CYP2C8 genotypes were determined by the TaqMan assay using genomic DNA. Multiple linear regression was applied to analyze the correlation between genotypes and the metabolic ratio.
RESULTS


The mean serum concentration-time curves of desloratadine and 3-OH-desloratadine were similar between the test product and reference product. For the PK similarity comparison, the 90% CIs for the geometric mean ratios of C<sub>max</sub>, AUC<sub>0- t</sub>, and AUC<sub>0-∞</sub> of desloratadine and 3-OH-desloratadine of test and reference product were completely within 80-125%. None of all 56 subjects had serious adverse events. Only 2 subjects were poor-metabolizers in 56 healthy subjects. There was no significant correlation between investigated genotypes of CYP2C8 and UGT2B10 and the metabolic ratio.
CONCLUSIONS


The test desloratadine tablet was bioequivalent to the reference product. No direct relationship between CYP2C8 and UGT2B10 genotypes and desloratadine metabolic ratio was identified.",2020,The mean serum concentration-time curves of desloratadine and 3-OH-desloratadine were similar between the test product and reference product.,"['Chinese healthy subjects', 'Chinese healthy subjects with different Desloratadine metabolic phenotypes', '56 healthy subjects', '56 Chinese healthy subjects']","['desloratadine', 'Desloratadine']","['pharmacokinetics (PK) and safety', 'CYP2C8 and UGT2B10 and the metabolic ratio', 'mean serum concentration-time curves of desloratadine and 3-OH-desloratadine', 'serious adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1382144', 'cui_str': 'Cytochrome p450 CYP2C8 enzyme'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",56.0,0.0314764,The mean serum concentration-time curves of desloratadine and 3-OH-desloratadine were similar between the test product and reference product.,"[{'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Niu', 'Affiliation': ""Clinical Trial institution, Scientific Research Department, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Jincheng General Hospital, Jincheng. China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Jiaxue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Nursing Department，Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Leiden Academic Center for Drug Research, Faculty of Science, Leiden University, Leiden. Netherlands.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Beijing United-Power Pharma Tech Co. Ltd, Beijing. China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Danjie', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': ""Clinical Trial institution, Scientific Research Department, Peking University People's Hospital, Beijing. China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital, Beijing. China.""}]",Current drug metabolism,['10.2174/1389200221999201027143903']
1779,33109094,Influence of dialysate temperature on creatinine peritoneal clearance in peritoneal dialysis patients: a randomized trial.,"BACKGROUND


Patients on continuous ambulatory peritoneal dialysis (PD) are encouraged to warm dialysate to 37 °C before peritoneal infusion; main international PD guidelines do not provide specific recommendation, and patients generally warm dialysate batches partially or do not warm them at all. Warming of dialysate is a time-consuming procedure, not free from potential risks (i.e. degradation of glucose), and should be justified by a clear clinical benefit.
METHODS


We designed a single blind randomized controlled trial where 18 stable PD patients were randomized to receive a peritoneal equilibration test either with dialysate at a controlled temperature of 37 °C (intervention group) or with dialysate warmed with conventional methods (control group). Primary end-point was a higher peritoneal creatinine clearance in patients in the intervention group.
RESULTS


Patients in the intervention group did not show a significantly higher peritoneal creatinine clearance when compared to the control group (6.38 ± 0.52 ml/min vs 5.65 ± 0.37 ml/min, p = 0.2682). Similar results were obtained for urea peritoneal clearance, mass transfer area coefficient of creatinine and urea. There were no significant differences in total abdominal discomfort questionnaire score, blood pressure and body temperature between the two groups.
CONCLUSIONS


Using peritoneal dialysate at different temperatures without causing significant side effects to patients appears feasible. We report a lack of benefit of warming peritoneal dialysate to 37 °C on peritoneal clearances; future PD guidelines should not reinforce this recommendation.
TRIAL REGISTRATION


NCT04302649, ClinicalTrials.gov ; date of registration 10/3/2020 (retrospectively registered).",2020,"RESULTS


Patients in the intervention group did not show a significantly higher peritoneal creatinine clearance when compared to the control group (6.38 ± 0.52 ml/min vs 5.65 ± 0.37 ml/min, p = 0.2682).","['Patients on continuous ambulatory peritoneal dialysis (PD', 'peritoneal dialysis patients', '18 stable PD patients']","['peritoneal equilibration test either with dialysate at a controlled temperature of 37\u2009°C (intervention group) or with dialysate warmed with conventional methods (control group', 'dialysate temperature']","['creatinine peritoneal clearance', 'urea peritoneal clearance, mass transfer area coefficient of creatinine and urea', 'peritoneal creatinine clearance', 'total abdominal discomfort questionnaire score, blood pressure and body temperature']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0430949', 'cui_str': 'Peritoneal equilibration test'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0449862', 'cui_str': 'Controlled temperature'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",,0.169948,"RESULTS


Patients in the intervention group did not show a significantly higher peritoneal creatinine clearance when compared to the control group (6.38 ± 0.52 ml/min vs 5.65 ± 0.37 ml/min, p = 0.2682).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fontana', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy. francesco.fontana@unimore.it.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Torelli', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Giovanella', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Ligabue', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Alfano', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Selgas', 'Affiliation': 'Nephrology Department, Hospital Universitario La Paz, IdiPAZ, Universidad Autonoma de Madrid, REDinREN, IRSIN, Madrid, Spain.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Cappelli', 'Affiliation': 'Surgical, medical and dental department of morphological sciences, Section of Nephrology, University of Modena and Reggio Emilia, Modena, Italy.'}]",BMC nephrology,['10.1186/s12882-020-02113-z']
1780,33109138,Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Côte d'Ivoire.,"BACKGROUND


Coverage of antenatal iron and folic acid supplementation (IFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. Evidence on the most effective ways to increase both IFASIPTp is mixed overall, with only few studies directly identifying cost-effective ways to increase coverage of both interventions. The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing IFAS and malaria chemoprophylaxis coverage among pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa.
METHODS/DESIGN


This study will be carried out in the Taabo health and demographic surveillance system (HDSS) in south-central Côte d'Ivoire. This is a cluster-randomized trial targeting 720 consenting pregnant women aged ≥15 years. The 118 clusters constituting the Taabo HDSS monitoring area will be randomly allocated to one of the following three groups with equal probability: a control group, an information only group, and an information plus home delivery group. To assess the relative effectiveness of each strategy, we will conduct an endline survey within the first 2 weeks after delivery. The primary outcomes of the trial will be maternal post-partum anaemia and malaria infection. Anaemia will be assessed using HEMOCUE devices; malaria infections will be assessed using standard rapid diagnostic tests named CareStart™ Malaria Pf (HRP2) Ag RDT (Multi Kit with capped lancet and inverted cup specimen transfer device). Other outcomes will include self-reported adherence to supplementation and malaria chemoprophylaxis, as well as miscarriages, stillbirths and low birth weight deliveries.
DISCUSSION


This study will assess the cost-effectiveness of two alternative strategies to increase antenatal IFAS and malaria chemoprophylaxis coverage among pregnant women in rural Côte d'Ivoire and similar settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04250428 ; Registered 31 January 2020.",2020,"The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing IFAS and malaria chemoprophylaxis coverage among pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa.
","['pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa', '720 consenting pregnant women aged ≥15\u2009years', ""rural south-central Côte d'Ivoire"", ""pregnant women in rural Côte d'Ivoire and similar settings"", '118 clusters constituting the Taabo HDSS monitoring area', ""Taabo health and demographic surveillance system (HDSS) in south-central Côte d'Ivoire""]","['IFASIPTp', 'antenatal iron and folic acid supplementation (IFAS', 'HRP2) Ag RDT (Multi Kit with capped lancet and inverted cup specimen transfer device', 'control group, an information only group, and an information plus home delivery group', 'antenatal iron and folic acid supplementation and malaria prophylaxis']","['cost, impact and relative cost-effectiveness', 'maternal post-partum anaemia and malaria infection', 'antenatal IFAS and malaria chemoprophylaxis coverage', 'cost-effectiveness']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0777169', 'cui_str': 'Lancet'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019857', 'cui_str': 'Home birth'}, {'cui': 'C0199244', 'cui_str': 'Antimalarial prophylaxis'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]",720.0,0.1605,"The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing IFAS and malaria chemoprophylaxis coverage among pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa.
","[{'ForeName': 'Siaka', 'Initials': 'S', 'LastName': 'Koné', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoires, 01 BP 1303, Abidjan 01, Côte d'Ivoire. siaka.kone@csrs.ci.""}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Probst-Hensch', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Daouda', 'Initials': 'D', 'LastName': 'Dao', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoires, 01 BP 1303, Abidjan 01, Côte d'Ivoire.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Fink', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",BMC public health,['10.1186/s12889-020-09626-0']
1781,33109148,Effectiveness of oral health promotion program for persons with severe mental illness: a cluster randomized controlled study.,"OBJECTIVE


To evaluate the effectiveness of a composite oral health promotion program designed to reduce dental plaque among persons with severe mental illness in a psychiatric institution.
METHODS


A cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment. Each participant responded to a questionnaire regarding oral health knowledge, attitude and behavior before and after the experiment.
RESULTS


Fifty-eight individuals completed the study. Before the experiment, the plaque index was similar between the intervention group (68.9; N = 27) and the control group (69.8; N = 31). After the experiment, the plaque index was significantly better in the intervention group than in the control group (42.6 vs. 61.8; P < 0.001). Participants in the intervention group also demonstrated better oral health knowledge, attitude and behavior than those in the control group after the experiment.
CONCLUSIONS


A composite oral health promotion program using both group education and individual behavioral methods over a 12-week period was effective in both reducing dental plaque and improving the oral health knowledge of persons with severe mental illness in the institution.
TRIAL REGISTRATION


This study was retrospectively registered in Clinicaltrials.gov, with number NCT04464941, dated 7/7/2020. https://register.clinicaltrials.gov/RD103035018 .",2020,"Participants in the intervention group also demonstrated better oral health knowledge, attitude and behavior than those in the control group after the experiment.
","['persons with severe mental illness', 'chronic psychiatric wards of a general hospital in central Taiwan', 'persons with severe mental illness in the institution', 'persons with severe mental illness in a psychiatric institution', 'Sixty-eight eligible male individuals admitted to 2 wards', 'Fifty-eight individuals completed the study']","['composite oral health promotion program', 'oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course', 'oral health promotion program', 'usual care only']","['oral health knowledge, attitude and behavior', 'plaque index', 'Dental plaque']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",68.0,0.0310114,"Participants in the intervention group also demonstrated better oral health knowledge, attitude and behavior than those in the control group after the experiment.
","[{'ForeName': 'Mei-Wen', 'Initials': 'MW', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychiatry, Chang Bing Show Chwan Memorial Hospital, No. 6, Lugong Rd., Lugang Township, Changhua County, 505, Taiwan, ROC.'}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Yeh', 'Affiliation': 'Institute of Long-Term Care, MacKay Medical College, New Taipei City, Taiwan, ROC.'}, {'ForeName': 'Heng-Ming', 'Initials': 'HM', 'LastName': 'Chang', 'Affiliation': 'Orthodontic and Dental Department, Chang Bing Show Chwan Memorial Hospital, Changhua County, Taiwan, ROC.'}, {'ForeName': 'Po-Ren', 'Initials': 'PR', 'LastName': 'Teng', 'Affiliation': 'Department of Psychiatry, Chang Bing Show Chwan Memorial Hospital, No. 6, Lugong Rd., Lugang Township, Changhua County, 505, Taiwan, ROC. porenten@ms23.hinet.net.'}]",BMC oral health,['10.1186/s12903-020-01280-7']
1782,33109241,Sex differences in fatigability after ischemic preconditioning of non-exercising limbs.,"BACKGROUND


Ischemic preconditioning (IPC) is suggested to decrease fatigability in some individuals but not others. Sex differences in response to IPC may account for this variability and few studies systematically investigated the effects of IPC in men and women. The goal of this study was to determine if time to task failure, perception of pain, and neuromuscular mechanisms of fatigability were altered by IPC in men and women.
METHODS


Ten women (29 ± 5 years old) and 10 men (28 ± 6 years old) performed isometric contractions with the plantar flexor muscles of the dominant leg at 20% of maximal voluntary contraction until task failure. We used a repeated measures design where each individual performed 3 randomized and counterbalanced test sessions: (A) IPC session, cuff inflation and deflation (5 min each repeated 3 times) performed before the exercise by inflating cuffs to the non-dominant leg and arm; (B) sham session, cuffs were inflated for a short period (1 min); and (C) control session, no cuffs were involved.
RESULTS


Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51). In men, but not women, the IPC-induced increase in time to task failure was associated with lower response to pressure pain (r = - 0.79). IPC further exposed sex differences in arterial pressure during fatiguing contractions (session × sex: P < 0.05). Voluntary activation, estimated with the twitch interpolation technique, and presynaptic inhibition of leg Ia afferents were not altered after IPC for men and women. The tested variables were not altered with sham.
CONCLUSIONS


The ergogenic effect of IPC on time to task failure was observed only in men and it was associated with reductions in the perception of pain. This pilot data suggest the previously reported inter-individual variability in exercise-induced fatigability after IPC could be a consequence of the sex and individual response to pain.",2020,"Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51).","['men and women', 'Ten women (29 ± 5\u2009years old) and 10 men (28 ± 6\u2009years old) performed']","['IPC', 'isometric contractions with the plantar flexor muscles of the dominant leg at 20% of maximal voluntary contraction until task failure', 'Ischemic preconditioning (IPC']","['Voluntary activation, estimated with the twitch interpolation technique, and presynaptic inhibition of leg Ia afferents', 'time to task failure', 'arterial pressure', 'IPC increased time to task failure', 'perception of pain', 'pressure pain', 'time to task failure, perception of pain, and neuromuscular mechanisms of fatigability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",10.0,0.117824,"Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51).","[{'ForeName': 'Hugo M', 'Initials': 'HM', 'LastName': 'Pereira', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, 1401 Asp Ave, Norman, OK, 73019, USA. hugomax@ou.edu.'}, {'ForeName': 'Felipe F', 'Initials': 'FF', 'LastName': 'de Lima', 'Affiliation': 'Biomedical Engineering Laboratory/EPUSP, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Silva', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Kohn', 'Affiliation': 'Biomedical Engineering Laboratory/EPUSP, University of São Paulo, São Paulo, SP, Brazil.'}]",Biology of sex differences,['10.1186/s13293-020-00338-z']
1783,33109240,Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST-Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial.,"BACKGROUND


Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic paediatric ocular inflammatory condition that can result in visual impairment. Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab.
METHODS


The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multicentred, international trial that will randomise 118 participants aged 2 years and older with controlled JIA-associated uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if < 30 kg) or 40 mg biweekly (if ≥ 30 kg).
DISCUSSION


This is the first randomised controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03816397. Registered on 25 January 2019. EudraCT 2019-000412-29. Registered on 17 January 2019.",2020,"Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost.","['118 participants aged 2\u2009years and older with controlled JIA-associated uveitis to either continue', 'patients with controlled juvenile idiopathic arthritis-associated uveitis', 'Juvenile Idiopathic Arthritis-associated Uveitis Trial']","['Adalimumab', 'discontinuing adalimumab', 'adalimumab or placebo', 'Discontinuing adalimumab', 'adalimumab or discontinue adalimumab and receive a placebo']",['time to uveitis recurrence'],"[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",118.0,0.36274,"Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost.","[{'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94143, USA. nisha.acharya@ucsf.edu.'}, {'ForeName': 'Caleb D', 'Initials': 'CD', 'LastName': 'Ebert', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Kelly', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Athimalaipet V', 'Initials': 'AV', 'LastName': 'Ramanan', 'Affiliation': 'Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol, BS2 8BJ, UK.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04796-z']
1784,33109244,Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19.
TRIAL DESIGN


The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups.
PARTICIPANTS


The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
INTERVENTION AND COMPARATOR


Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences.
MAIN OUTCOMES


The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization.
RANDOMISATION


Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule.
BLINDING (MASKING)


The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The calculated total sample size is 40 patients, with 10 patients in each group.
TRIAL STATUS


The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020.
TRIAL REGISTRATION


This clinical trial has been registered by the title of ""Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial"" in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20090609002017N35 "", https://www.irct.ir/trial/48058 . The registration date is 17 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients with COVID-19', 'patients with COVID-19', 'The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial', '40 patients, with 10 patients in each group', 'Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran']","['oleoylethanolamide', 'placebo', 'oleoylethanolamide supplementation', 'boron-containing compounds and oleoylethanolamide supplementation']","['recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006030', 'cui_str': 'Boron'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.452636,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Pourmoradian', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Soleimanzadeh', 'Affiliation': 'Department of Applied Chemistry, Faculty of Chemistry, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Kafil', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Monshikarimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran. ostadrahimi@tbzmed.ac.ir.'}]",Trials,['10.1186/s13063-020-04820-2']
1785,33109246,Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill.
TRIAL DESIGN


This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS


All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria.
INCLUSION CRITERIA


1. Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. 2. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. 3. Hospitalized ≤ 48 h. 4. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA


1. Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. 2. Severe and critical COVID-19 pneumonia. 3. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. 4. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR


Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day.
CONTROL GROUP


lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups.
MAIN OUTCOMES


The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O 2  saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization.
RANDOMIZATION


Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms.
BLINDING (MASKING)


This is an open-label trial without blinding and placebo control.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group).
TRIAL STATUS


The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3 . Registered on 22 July 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a.","['60 patients', 'Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'patients with confirmed COVID-19, who are moderately ill', 'All patients with age\u2009≥\u200920\u2009years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria', 'moderately ill patients with COVID-19']","['lopinavir/ritonavir and interferon', 'favipiravir and interferon', 'GROUP\n\n\nlopinavir/ritonavir', 'lopinavir/ritonavir', 'Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran', 'placebo', 'favipiravir, lopinavir/ritonavir, and interferon beta-1a']","['chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers', 'length of hospital stay and the incidence of serious adverse drug reactions', 'viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR', 'clinical improvement of fever and O 2  saturation', 'Severe and critical COVID-19 pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019189', 'cui_str': 'Chronic hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0860204', 'cui_str': 'Cholestatic liver disease'}, {'cui': 'C0008325', 'cui_str': 'Cholecystitis'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",60.0,0.170662,"History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bazram', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04747-8']
1786,33118432,Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK).,"PURPOSE


To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).
MATERIALS AND METHODS


The prospective, multicenter, randomized study AcoArt II-BTK study ( ClinicalTrials.gov  identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months.
RESULTS


Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53).
CONCLUSION


This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.",2020,The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.,"['n=59; mean age 70.8±9.0 years; 36 men', '120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a', 'patients with chronic limb-threatening ischemia (CLTI']","['Drug-Coated Balloon Angioplasty', 'Litos/Tulip DCBs', 'drug-coated balloon (DCB) vs uncoated balloon angioplasty', 'Uncoated Balloons', 'DCB', 'conventional balloon catheter', 'plain balloon angioplasty']","['baseline clinical or target lesion characteristics', 'safety and efficacy', 'target lesion length', 'late lumen loss', 'mortality and clinically-driven target lesion revascularization (CD-TLR', 'mortality']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0331680', 'cui_str': 'Tulipa'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",120.0,0.0762924,The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Baixi', 'Initials': 'B', 'LastName': 'Zhuang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xinwu', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiangchen', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Zhaoyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bi', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Shenming', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820969681']
1787,33118433,Satisfactory Long-term Outcomes of Thoracic Endovascular Aortic Repair With a Bare Stent for Acute Complicated Type B Aortic Dissections.,"PURPOSE


To compare the clinical outcomes after thoracic endovascular aortic repair (TEVAR) with a bare stent to those after TEVAR alone in patients with complicated acute type B aortic dissection (cATBAD).
MATERIALS AND METHODS


A prospective, randomized trial was conducted at 2 medical centers in China between 2010 and 2013. Patients with cATBAD were randomly assigned to receive TEVAR with a bare stent (n=42) or TEVAR only (n=42). Patients were scheduled to undergo computed tomography angiography at 3, 6, and 12 months and then annually to 5 years. The primary endpoint was all-cause mortality at 5 years; secondary outcomes were a composite of complications (endoleak, stent-graft-induced new entry, aortic rupture, and secondary intervention) and aortic remodeling at 1 and 5 years.
RESULTS


All-cause death occurred in 1 (2.4%) patient in the TEVAR with bare stent group (lung cancer) and 5 patients (11.9%) in the TEVAR group (4 aorta-related) during the 5-year follow-up (log-rank p=0.025). The 1- and 5-year rates of complications and secondary interventions did not differ between the groups. Patients in the TEVAR with bare stent group had higher increases in the thoracic true lumen diameter (19.7±3.6 vs 17.0±6.2 mm, p=0.018) and abdominal true lumen diameter (13.7±4.8 vs 7.2±6.1 mm, p<0.001) and a higher incidence of complete false lumen thrombosis (80.9% vs 47.6%, p=0.005) at the 1-year follow-up. However, no between-group differences in the changes of aortic remodeling parameters were observed between the 1- and 5-year follow-up periods.
CONCLUSION


The addition of a distal bare stent to a thoracic stent-graft during TEVAR was associated with significantly improved long-term survival in cATBAD patients vs TEVAR only, likely due to the prevention of true lumen collapse and improvement of complete false lumen thrombosis of the dissected aorta.",2020,The 1- and 5-year rates of complications and secondary interventions did not differ between the groups.,"['2 medical centers in China between 2010 and 2013', 'patients with complicated acute type B aortic dissection (cATBAD', 'Patients with cATBAD', 'Acute Complicated Type B Aortic Dissections']","['Thoracic Endovascular Aortic Repair With a Bare Stent', 'TEVAR alone', 'thoracic endovascular aortic repair (TEVAR', 'TEVAR', 'TEVAR with a bare stent (n=42) or TEVAR', 'computed tomography angiography']","['long-term survival', 'cause mortality', 'aortic remodeling parameters', 'All-cause death', 'composite of complications (endoleak, stent-graft-induced new entry, aortic rupture, and secondary intervention) and aortic remodeling at 1 and 5 years', 'complete false lumen thrombosis', '1- and 5-year rates of complications and secondary interventions', 'thoracic true lumen diameter', 'abdominal true lumen diameter']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340647', 'cui_str': 'Dissection of distal aorta'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1504464', 'cui_str': 'Endoleak'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003496', 'cui_str': 'Aortic rupture'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",,0.0747711,The 1- and 5-year rates of complications and secondary interventions did not differ between the groups.,"[{'ForeName': 'Yaowang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianfan', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiology, Guangdong General Hospital, Guangdong Academy of Sciences, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Bei', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Pang', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820966991']
1788,33118436,Thai Police Officers' Attitudes Toward Intimate Partner Violence and Victim Blaming: The Influence of Sexism and Female Gender Roles.,"Police officers are typically the first responders when victims of intimate partner violence (IPV) report abuse. Therefore, police officers' attitudes toward IPV and victim blaming are crucial. This study aimed to observe how police officers' sexist attitudes affect their perspectives on IPV and their victim-blaming attitudes, depending on the gender role exhibited by the victim. The Ambivalent Sexism Inventory was used to classify 139 Thai male police officers into four groups of sexism: hostile sexist, benevolent sexist, ambivalent sexist, and nonsexist. Then, the participants were randomly assigned to watch a simulation video, in which a victim of IPV filed a report after being abused by her husband. There were two versions of the video, one in which the victim played a traditional gender role and the other a nontraditional role. Multivariate analysis of variance was employed for data analysis. The results demonstrated statistically significant effects of ambivalent sexism and victim's gender role on attitudes toward IPV and victim blaming. This study contributes to the growing body of research on police officers' performances in the context of IPV in Thailand and contributes to existing scholarship. It provides Thai police precincts with information that can equip them to develop new sensitivity training programs and can help legislators improve the effectiveness of victim protection acts.",2020,The results demonstrated statistically significant effects of ambivalent sexism and victim's gender role on attitudes toward IPV and victim blaming.,"['139 Thai male police officers into four groups of sexism: hostile sexist, benevolent sexist, ambivalent sexist, and nonsexist']",[],[],"[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}]",[],[],139.0,0.0135702,The results demonstrated statistically significant effects of ambivalent sexism and victim's gender role on attitudes toward IPV and victim blaming.,"[{'ForeName': 'Piyakrita', 'Initials': 'P', 'LastName': 'Kruahiran', 'Affiliation': '1Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Watcharaporn', 'Initials': 'W', 'LastName': 'Boonyasiriwat', 'Affiliation': '1Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kakanang', 'Initials': 'K', 'LastName': 'Maneesri', 'Affiliation': '1Chulalongkorn University, Bangkok, Thailand.'}]",Journal of interpersonal violence,['10.1177/0886260520969405']
1789,33118443,A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of  Breathe Easier : A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads).,"Objective:  Symptom burden remains a distressing problem for survivors with non-small-cell lung cancer (stages I-IIIa). This pilot study evaluated feasibility and preliminary effects of a tailored mindfulness-based intervention, Breathe Easier, which encompasses meditation, 2 levels of mindful hatha yoga, breathing exercises, and participant interaction.
METHODS


Participants were recruited from 2 cancer programs in the US Southeast. A family member was required for participation. Sixty-two participants enrolled (20% recruitment) and 49 completed the intervention (79% retention). Participants chose level 1 yoga (basic) or level 2 (more advanced). Of the completers, survivors were 39% male and 65% Black. A community-based participatory research framework helped identify the specific needs and interests of potential participants and foreseeable barriers to implementation. A 2-month prospective, 1-group, pre-post design evaluated feasibility. Intervention dosage was measured using written protocols. Attendance and completion of daily home assignments measured adherence. Acceptability was assessed using a 10-item questionnaire, completed at three time points. Preliminary outcome data collected pre- and post-intervention tested the hypothesis that participants who received the 8-week intervention Breathe Easier would, post-intervention, demonstrate (a) less dyspnea, (b) less fatigue, (c) less stress, (d) improved sleep, (e) improved anxiety and depression, and (f) improved functional exercise capacity. Exit interviews were conducted, transcribed verbatim, and analyzed for content using descriptive statistics.
RESULTS


Quantitative and qualitative measures indicated strong feasibility. Over time, level 1 participants had statistically less dyspnea, fatigue and improved exercise capacity, as well as improved sleep, and stress scores. Level 2 participants experienced slightly increased dyspnea and fatigue but improved sleep, stress, and exercise capacity. All participants experienced anxiety and depression within normal limits pre- and post-intervention. Five major themes emerged out of exit interviews: Learning to Breathe Easier; Interacting with Others as a Personal Benefit; Stretching, Releasing Tension, and Feeling Energized; Enhancing Closeness with Committed Partners; Refocusing on Living; and Sustaining New Skills as a Decision.
CONCLUSIONS


The study offers insight into the feasibility of an 8-week in-person mindfulness-based intervention with a unique subset of understudied survivors of lung cancer and family members. Outcome data interpretation is limited by the 1-group design and sample size.",2020,"Over time, level 1 participants had statistically less dyspnea, fatigue and improved exercise capacity, as well as improved sleep, and stress scores.","['understudied survivors of lung cancer and family members', 'survivors with non-small-cell lung cancer (stages I-IIIa', 'Sixty-two participants enrolled (20% recruitment) and 49 completed the intervention (79% retention', 'Participants were recruited from 2 cancer programs in the US Southeast', 'Participants chose level 1 yoga (basic) or level 2 (more advanced', 'Survivors of Lung Cancer and Their Family Members (Dyads']","['Breathe Easier ', 'person mindfulness-based intervention', 'tailored mindfulness-based intervention, Breathe Easier, which encompasses meditation, 2 levels of mindful hatha yoga, breathing exercises, and participant interaction', 'Mindfulness-based Intervention', 'collected pre- and post-intervention']","['dyspnea, fatigue and improved exercise capacity', 'dyspnea and fatigue but improved sleep, stress, and exercise capacity', 'Acceptability', 'dyspnea, (b) less fatigue, (c) less stress, (d) improved sleep, (e) improved anxiety and depression, and (f) improved functional exercise capacity', 'improved sleep, and stress scores', 'anxiety and depression']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",62.0,0.0383263,"Over time, level 1 participants had statistically less dyspnea, fatigue and improved exercise capacity, as well as improved sleep, and stress scores.","[{'ForeName': 'Karen Kane', 'Initials': 'KK', 'LastName': 'McDonnell', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Gallerani', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Brandi R', 'Initials': 'BR', 'LastName': 'Newsome', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Otis L', 'Initials': 'OL', 'LastName': 'Owens', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jenay', 'Initials': 'J', 'LastName': 'Beer', 'Affiliation': 'University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Myren-Bennett', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Regan', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hardin', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Webb', 'Affiliation': 'Dallas VA Medical Center, Dallas, TX, USA.'}]",Integrative cancer therapies,['10.1177/1534735420969829']
1790,33118456,Parent Ethical Concerns About Patient Feedback Measures to Improve Pediatric Clinical Care.,"There are limited studies evaluating parental willingness to complete patient feedback measures to improve pediatric clinical care. Parents were randomly assigned to read a vignette that varied by parent satisfaction and type of feedback measure. Parents were generally willing to participate in the hypothetical research study aimed to improve their child's clinical care. Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate. Researchers aiming to improve pediatric clinical care should be encouraged to use patient feedback measures that collect potentially identifiable information; however, researchers must consider the potential impact of parent satisfaction on feedback.",2020,"Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate.",[],[],[],[],[],[],,0.0178364,"Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate.","[{'ForeName': 'Paulina S', 'Initials': 'PS', 'LastName': 'Lim', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Lang', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'W Hobart', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620969327']
1791,33118677,"Combined isobutylamido thiazolyl resorcinol and low-fluence Q-switched Nd: YAG laser for the treatment of facial hyperpigmentation: A randomized, split-face study.","BACKGROUND


Isobutylamido thiazolyl resorcinol (ITR) is a novel anti-tyrosinase recently shown to be effective in the treatment of hyperpigmentation. Low-fluence Q-switched Nd:YAG 1064-nm laser (LFQS) has proven to be effective for various hyperpigmentary conditions. However, there is no study on the efficacy and safety of combined ITR and LFQS treatment.
OBJECTIVES


To compare the efficacy and safety of combined ITR and LFQS with LFQS monotherapy for facial hyperpigmentation.
MATERIALS AND METHODS


Patients with symmetrical facial hyperpigmentation were treated with five sessions of once weekly LFQS on the whole face. One side was randomly treated with ITR and the other side received a placebo cream for 12 weeks. Patients were followed for 8 weeks after the last laser treatment. Relative lightness index (RL*I), Facial Hyperpigmentation Severity Score on the malar area (FHSS m  ), patient satisfaction, recurrence, and adverse events were recorded.
RESULTS


Twenty-four patients completed the study. Both sides demonstrated significant reductions of mean RL*I and mean FHSS m  from baseline (P < .01). At the 4th week, the ITR-treated side showed more improvement of mean RL*I than the placebo-treated side (62.5% vs 47.3% improvement, P < .05). The mean FHSS m  on the ITR-treated was reduced at a significantly higher percentage than the placebo-treated side (54.4% vs 40.2% reduction, P < .05). Partial recurrence was observed on both sides. No serious side effects were noted.
CONCLUSION


Combined ITR and LFQS therapy was more superior than LFQS monotherapy in the treatment of facial hyperpigmentation. ITR may serve as adjuvant for patients with such condition.",2020,Both sides demonstrated significant reductions of mean RL*I and mean FHSS m  from baseline (P < .01).,"['Patients with symmetrical facial hyperpigmentation', 'facial hyperpigmentation', 'Twenty-four patients completed the study', 'patients with such condition']","['Combined isobutylamido thiazolyl resorcinol and low-fluence Q-switched Nd', 'LFQS', 'ITR', 'LFQS monotherapy', 'combined ITR and LFQS with LFQS monotherapy', 'Low-fluence Q-switched Nd:YAG 1064-nm laser (LFQS', 'placebo cream', 'YAG laser', 'Isobutylamido thiazolyl resorcinol (ITR', 'Combined ITR and LFQS therapy']","['Partial recurrence', 'mean RL*I and mean FHSS m', 'serious side effects', 'efficacy and safety', 'facial hyperpigmentation', 'mean RL*I', 'mean FHSS m  on the ITR-treated', 'Relative lightness index (RL*I), Facial Hyperpigmentation Severity Score on the malar area (FHSS m  ), patient satisfaction, recurrence, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035197', 'cui_str': 'meta-Dihydroxybenzenes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035197', 'cui_str': 'meta-Dihydroxybenzenes'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.0305888,Both sides demonstrated significant reductions of mean RL*I and mean FHSS m  from baseline (P < .01).,"[{'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kanchana', 'Initials': 'K', 'LastName': 'Leerunyakul', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chaninan', 'Initials': 'C', 'LastName': 'Kositkuljorn', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Chayavichitsilp', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13790']
1792,33118688,Building clinical risk score systems for predicting the all-cause and expanded cardiovascular-specific mortality of patients with type 2 diabetes.,"AIMS


A model has yet to be developed for predicting mortality in relation to the effect of glycemic and blood pressure variabilities, which are important clinical predictors of the mortality of patients, especially those with diabetes. This study aimed to develop and validate risk score systems by examining the effects of glycemic and blood pressure variabilities on the all-cause and expanded cardiovascular-specific mortality of persons with type 2 diabetes.
MATERIALS AND METHODS


This retrospective cohort study consisted of 9,692 patients aged 30-85 years, diagnosed with type 2 diabetes, and enrolled in a managed care program of a medical center from 2002 to 2016. All the patients were randomly allocated into two groups, namely, training and validation sets (2:1 ratio), and followed up until death or August 2019. Cox's proportional hazard regression was performed to develop all-cause and expanded cardiovascular-specific mortality prediction models. The performance of the prediction model was assessed by using the area under the receiver operating characteristic curve (AUROC).
RESULTS


Overall, 2,036 deaths were identified after a mean of 8.6 years of follow-up. The AUROC-measured prediction accuracies of 3-, 5-, 10-, and 15-year all-cause mortalities based on a model containing the identified traditional risk factors, biomarkers, and variabilities in fasting plasma glucose, HbA1c, and blood pressure in the validation set were 0.79 (0.76-0.83), 0.78 (0.76--0.81), 0.80 (0.78--0.82), and 0.80 (0.78--0.82), respectively. The corresponding values of the expanded cardiovascular-specific mortalities were 0.85 (0.80--0.90), 0.83 (0.79--0.86), 0.80 (0.77--0.83), and 0.79 (0.77--0.82), respectively.
CONCLUSIONS


Our prediction models considering glycemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes. This article is protected by copyright. All rights reserved.",2020,Our prediction models considering glycemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes.,"['patients with type 2 diabetes', 'persons with type 2 diabetes', '9,692 patients aged 30-85\u2009years, diagnosed with type 2 diabetes, and enrolled in a managed care program of a medical center from 2002 to 2016']",[],"['fasting plasma glucose, HbA1c, and blood pressure', 'corresponding values of the expanded cardiovascular-specific mortalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024679', 'cui_str': 'Managed Health Care Insurance Plans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",9692.0,0.0171368,Our prediction models considering glycemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes.,"[{'ForeName': 'Chiu-Shong', 'Initials': 'CS', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chia-Ing', 'Initials': 'CI', 'LastName': 'Li', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Mu-Cyun', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Sing-Yu', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Public Health, College of Public Health, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Tsai-Chung', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Department of Public Health, College of Public Health, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14240']
1793,33118696,Three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to Xience everolimus-eluting stent in routine PCI in patients with diabetes mellitus-AIDA sub-study.,"BACKGROUND


In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up.
METHODS AND RESULTS


All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively).
CONCLUSIONS


In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.",2020,"Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.","['All 1,845 randomized patients were subdivided by medical history with DM or without DM', '921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM', '924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM', 'patients with diabetes mellitus (DM) at complete 3-year follow-up', 'diabetic patients', 'patients with diabetes mellitus-AIDA sub-study']","['routine percutaneous coronary intervention (PCI', 'Xience everolimus-eluting stent (EES', 'Xience everolimus-eluting stent', 'absorb bioresorbable vascular scaffold (BVS']","['device thrombosis', 'rates of TVF', 'Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization', 'Definite/probable device thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",1845.0,0.102209,"Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.","[{'ForeName': 'Laura S M', 'Initials': 'LSM', 'LastName': 'Kerkmeijer', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruben Y G', 'Initials': 'RYG', 'LastName': 'Tijssen', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'E Karin', 'Initials': 'EK', 'LastName': 'Arkenbout', 'Affiliation': 'The Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Auke P J D', 'Initials': 'APJD', 'LastName': 'Weevers', 'Affiliation': 'The Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Kraak', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thorax Center, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'NHLI, Imperial College London, London, UK.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29329']
1794,33118716,Randomized controlled trial comparing embryonic quality in rFSH versus hMG in the IVF protocol with GnRH Antagonist.,"OBJECTIVE


The aim of the present study is to investigate embryo quality (score) after controlled ovarian stimulation for IVF using rFSH or hMG with the GnRH antagonist protocol.
METHODS


Open, randomized, single center study. The patients were randomized to receive rFSH or hMG according to randomized cards inside a black envelope with the name of the respective treatment following a computer generated list (85 patients were allocated to rFSH group and 83 patients to hMG group). Inclusion criteria were patients with IVF indication and normal ovarian reserve. Embryo evaluation was performed on day three, after fertilization based on the Graduated Embryo Score (GES).
RESULTS


There were no relevant differences in demographic characteristics. There was no difference in pregnancy rates with 27 (31%) and 25 (30.1%) pregnancies for rFSH and hMG, respectively (p=0.87). The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03). The total number of embryos was statistical different, also in favor of the rFSH group (4.17±3.1 x 3.26±2.4 p=0.04).
CONCLUSION


The total embryo score was the same for both groups, but the best embryo score was significantly higher for the rFSH group. Moreover, rFSH was associated with an increased number of embryos.",2020,"The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03).",['Inclusion criteria were patients with IVF indication and normal ovarian reserve'],"['rFSH versus hMG', 'rFSH or hMG', 'rFSH']","['total embryo score', 'pregnancy rates', 'number of embryos', 'total number of embryos', 'embryo score', 'embryo quality (score', 'Graduated Embryo Score (GES', 'best embryo score']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}]","[{'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",85.0,0.163386,"The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03).","[{'ForeName': 'Rita de Cassia Borges', 'Initials': 'RCB', 'LastName': 'Chapon', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'Vanessa Krebs', 'Initials': 'VK', 'LastName': 'Genro', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'Carlos Augusto Bastos de', 'Initials': 'CAB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'João Sabino Lahorgue da', 'Initials': 'JSLD', 'LastName': 'Cunha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200064']
1795,33118727,Comparison between the Effects of Bretschneider's HTK Solution and Cold Blood Cardioplegia on Systemic Endothelial Functions in Patients who Undergo Coronary Artery Bypass Surgery: a Prospective Randomized and Controlled Trial.,"OBJECTIVE


To investigate the effects of Bretschneider's histidine-tryptophan-ketoglutarate (HTK) solution and cold blood cardioplegia on systemic endothelial functions.
METHODS


A total of 50 patients who underwent isolated coronary artery bypass surgery between March 2018 and May 2018 were randomly divided into two groups - group 1 (Bretschneider's HTK solution, n=25) and group 2 (cold blood cardioplegia, n=25). Data related to the indicators of endothelial dysfunction were recorded. Flow-mediated dilation was measured together with the assessment of the values of endothelin-1, von Willebrand factor, and asymmetric dimethylarginine to identify endothelial dysfunction. Then, the two groups were compared regarding these values.
RESULTS


The most significant result of our study was that the endothelin-1 level was significantly higher in group 2 than in group 1 (P<0.001). The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
CONCLUSION


Cardiopulmonary bypass leads to endothelial dysfunction. Our results revealed that Bretschneider's HTK solution causes less severe endothelial injury than cold blood cardioplegia.",2020,"The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
","['Patients who Undergo Coronary Artery Bypass Surgery', '50 patients who underwent isolated coronary artery bypass surgery between March 2018 and May 2018']","[""Bretschneider's HTK solution"", ""Bretschneider's histidine-tryptophan-ketoglutarate (HTK) solution and cold blood cardioplegia"", ""Bretschneider's HTK Solution and Cold Blood Cardioplegia"", "" group 1 (Bretschneider's HTK solution, n=25) and group 2 (cold blood cardioplegia""]","['Flow-mediated dilation', 'Systemic Endothelial Functions', 'endothelin-1 level', 'endothelial dysfunction', 'value of flow-mediated dilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0054039', 'cui_str': 'Bretschneider cardioplegic solution'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0289154,"The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
","[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Mercan', 'Affiliation': 'Konya Training and Research Hospital Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Dereli', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Cemile', 'Initials': 'C', 'LastName': 'Topcu', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Biochemistry Konya Turkey Department of Biochemistry, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Tanyeli', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Isik', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Niyazi', 'Initials': 'N', 'LastName': 'Gormus', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Elifnur Yildirim', 'Initials': 'EY', 'LastName': 'Ozturk', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Public Health Konya Turkey Department of Public Health, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0327']
1796,33118847,"Efficacy and safety of iguratimod on patients with primary Sjögren's syndrome: a randomized, placebo-controlled clinical trial.","Objective:  To evaluate the clinical efficacy and safety of iguratimod for the treatment of primary Sjögren's syndrome (pSS) and explore its possible mechanism of action.  Method:  We conducted a randomized, placebo-controlled clinical trial in 66 pSS patients. Patients were randomized in a 2:1 ratio to receive oral iguratimod for 24 weeks or matching placebo. The primary endpoint was the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI). Secondary endpoints included mental discomfort visual analogue scale (VAS) score, patient global assessment (PGA), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Schirmer's test values, unstimulated whole salivary flow, erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG). The proportions of B cells in peripheral blood and levels of serum B-cell activating factor (BAFF) were measured at baseline and week 24 in the iguratimod group. All adverse events were recorded during the trial period.  Results: ESSPRI improved more in the iguratimod than in the placebo group (p = 0.016). Mental discomfort VAS score, PGA, Schirmer's test, ESR, and IgG also improved more in the iguratimod than in the placebo group (all p < 0.05). Adverse events were reported 13.6% of the iguratimod group. Levels of BAFF and proportions of plasma cells in patients decreased significantly after iguratimod treatment. The proportions of peripheral plasma cells had positive correlations with both serum IgG and BAFF.  Conclusion:  Iguratimod improved some dryness symptoms and disease activity in pSS patients, and reduced the level of BAFF and percentage of plasma cells over 24 weeks. Iguratimod seems to be an effective and safe treatment for pSS.",2020,ESSPRI improved more in the iguratimod than in the placebo group (p = 0.016).,"[""primary Sjögren's syndrome (pSS"", '66 pSS patients', ""patients with primary Sjögren's syndrome""]","['iguratimod', 'placebo', 'oral iguratimod for 24\xa0weeks or matching placebo']","['Levels of BAFF and proportions of plasma cells', 'ESSPRI', ""EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI"", 'proportions of B cells in peripheral blood and levels of serum B-cell activating factor (BAFF', 'Adverse events', 'dryness symptoms and disease activity', 'Efficacy and safety', ""mental discomfort visual analogue scale (VAS) score, patient global assessment (PGA), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Schirmer's test values, unstimulated whole salivary flow, erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG"", 'clinical efficacy and safety', ""Mental discomfort VAS score, PGA, Schirmer's test, ESR, and IgG"", 'level of BAFF and percentage of plasma cells']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1872427', 'cui_str': 'iguratimod'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1682317', 'cui_str': 'TNFSF13B protein, human'}, {'cui': 'C0032112', 'cui_str': 'Plasma cell'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",66.0,0.32744,ESSPRI improved more in the iguratimod than in the placebo group (p = 0.016).,"[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Department of Rheumatology, Chongqing City Hospital of Traditional Chinese Medicine , Chongqing, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Chongqing City Hospital of Traditional Chinese Medicine , Chongqing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Chongqing City Hospital of Traditional Chinese Medicine , Chongqing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Chongqing City Hospital of Traditional Chinese Medicine , Chongqing, China.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1809701']
1797,33118896,The taste of biodiversity - Science and sensory education with different varieties of a vegetable to promote acceptance among primary school children.,"OBJECTIVE


To determine the impact of an educational program for primary schools that explored the biodiversity of tomato, by promoting science and sensory education with three distinct varieties of it, in the acceptance of vegetables.
DESIGN


A randomized controlled study in which children were exposed to the educational program (intervention group) or remained in the class, as usual (control group). The educational program consisted of three sessions where children explained the observed differences between the three varieties of tomato and individual perceptions of their flavors based on sensory-based food education and by planning and implementing experiments to explain those differences. We tested the effects on both children's willingness to try and their liking for tomato, and for lettuce and cabbage to study the carry-over effect, compared with the control group (Mann-Whitney U test; p < 0.05).
SETTING


The study took place in public primary schools in Porto, Portugal.
PARTICIPANTS


Children in the third grade (8-13-year-old children) (n 136) that were randomly assigned to intervention or control group.
RESULTS


Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (p < 0.05), but not for lettuce and cabbage (p > 0.05).
CONCLUSIONS


These results highlight the potential for fostering children's acceptance of a vegetable by exploring biodiversity through science education. Further work may clarify the effects of exploring biodiversity on the consumption of vegetables and establish whether the results are stable over time and replicable across contexts and populations.",2020,"RESULTS


Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (p < 0.05), but not for lettuce and cabbage (p > 0.05).
","['public primary schools in Porto, Portugal', 'primary school children', 'Children in the third grade (8-13-year-old children) (n 136']","['intervention or control group', 'educational program (intervention group) or remained in the class, as usual (control group', 'educational program']",['willingness to try and liking for tomato'],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242772', 'cui_str': 'Tomato'}]",,0.0162802,"RESULTS


Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (p < 0.05), but not for lettuce and cabbage (p > 0.05).
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Afonso', 'Affiliation': 'Center for Psychology, Rua Alfredo Allen, 4200-135Porto, Portugal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aboim', 'Affiliation': 'P. Porto: School of Education, Rua Dr. Roberto Frias, 602; 4200-465Porto, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Pessoa', 'Affiliation': 'Portuguese Association of Science Education - APEduC, Rua Faria Vasconcelos, 6000-266Castelo Branco, Portugal.'}, {'ForeName': 'Xana', 'Initials': 'X', 'LastName': 'Sá-Pinto', 'Affiliation': 'P. Porto: School of Education, Rua Dr. Roberto Frias, 602; 4200-465Porto, Portugal.'}]",Public health nutrition,['10.1017/S1368980020004371']
1798,33118901,Assessing the challenges to women's access and implementation of text messages for nutrition behaviour change in rural Tanzania.,"OBJECTIVE


This process evaluation aimed to understand factors affecting the implementation of a government-sponsored short message service (SMS) programme for delivering nutrition information to rural populations, including message access, acceptability and putting messages into action.
DESIGN


The study was nested within a larger randomised controlled trial. Cross-sectional data collection included structured surveys and in-depth interviews. Data were analysed for key trends and themes using Stata and ATLAS.ti software.
SETTING


The study took place in Tanzania's Mtwara region.
PARTICIPANTS


Surveys were conducted with 205 women and 93 men already enrolled in the randomised controlled trial. A sub-set of 30 women and 14 men participated in the in-depth interviews.
RESULTS


Among women relying on a spouse's phone, sharing arrangements impeded regular SMS access; men were commonly away from home, forgot to share SMS or did not share them in women's preferred way. Phone-owning women faced challenges related to charging their phones and defective handsets. Once SMS were delivered, most participants viewed them as trustworthy and comprehensible. However, economic conditions limited the feasibility of applying certain recommendations, such as feeding meat to toddlers. A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice.
CONCLUSIONS


The challenges to accessing and implementing SMS services highlighted here suggest that such platforms may work well as one component of a comprehensive nutrition intervention, yet not as an isolated effort.",2020,"A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice.
","['30 women and 14 men participated in the in-depth interviews', 'Surveys were conducted with 205 women and 93 men already enrolled in the randomised controlled trial', 'rural Tanzania']","['government-sponsored short message service (SMS) programme', 'interpersonal counselling (IPC) intervention']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],205.0,0.100166,"A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice.
","[{'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': 'Headquarters Nutrition Division, Helen Keller International, Washington, DC, USA.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Klemm', 'Affiliation': 'Headquarters Nutrition Division, Helen Keller International, Washington, DC, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Niyeha', 'Affiliation': 'Tanzania Country Office, Helen Keller International, Dar es Salaam, Tanzania.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Tanzania Country Office, Helen Keller International, Dar es Salaam, Tanzania.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Nordhagen', 'Affiliation': 'Global Alliance for Improved Nutrition, Geneva, Switzerland.'}]",Public health nutrition,['10.1017/S1368980020003742']
1799,33118908,Culturally adapted and lay-delivered cognitive behaviour therapy for older adults with depressive symptoms in rural China: a pilot trial.,"BACKGROUND


Late-life depression issues in developing countries are challenging because of understaffing in mental health. Cognitive behavioural therapy (CBT) is effective for treating depression.
AIM


This pilot trial examined the adherence and effectiveness of an eight-session adapted CBT delivered by trained lay health workers for older adults with depressive symptoms living in rural areas of China, compared with the usual care.
METHOD


Fifty with screen-positive depression were randomly assigned to the CBT arm or the care as usual (CAU) arm. The primary outcomes were the session completion of older adults and changes in depressive symptoms, assessed using the Geriatric Depression Scale (GDS).
RESULTS


The majority (19/24) of participants in the CBT arm completed all sessions. Mixed-effect linear regression showed that the CBT reduced more GDS scores over time compared with CAU.
CONCLUSION


Lay-delivered culturally adapted CBT is potentially effective for screen-positive late-life depression.",2020,"This pilot trial examined the adherence and effectiveness of an eight-session adapted CBT delivered by trained lay health workers for older adults with depressive symptoms living in rural areas of China, compared with the usual care.
","['Fifty with screen-positive depression', 'older adults with depressive symptoms living in rural areas of China, compared with the usual care', 'older adults with depressive symptoms in rural China']","['Cognitive behavioural therapy (CBT', 'eight-session adapted CBT', 'Culturally adapted and lay-delivered cognitive behaviour therapy', 'CBT']","['GDS scores', 'session completion of older adults and changes in depressive symptoms, assessed using the Geriatric Depression Scale (GDS']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",50.0,0.078453,"This pilot trial examined the adherence and effectiveness of an eight-session adapted CBT delivered by trained lay health workers for older adults with depressive symptoms living in rural areas of China, compared with the usual care.
","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Center for Behavioral Health & School of Social Development and Public Policy, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Peking University HuiLongGuan Clinical Medical School & Beijing Huilongguan Hospital, Beijing, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Tang', 'Affiliation': 'Department of Social Work, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'School of Public Health, University of Minnesota, MN, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Mental Health Education Center of College Student, Sichuan Normal University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Mianzhu Maternal and Child Health Hospital, Mianzhu, Sichuan, China.'}, {'ForeName': 'Fahui', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'Center for Behavioral Health & School of Social Development and Public Policy, Beijing Normal University, Beijing, China.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000818']
1800,33118927,"Effect of depression, anxiety, and stress symptoms on response to cognitive behavioral therapy for insomnia in patients with comorbid insomnia and sleep apnea: a randomized controlled triall.","STUDY OBJECTIVES


Patients with comorbid insomnia and sleep apnea (COMISA) report increased severity of depression, anxiety, and stress symptoms compared to patients with either insomnia or sleep apnea alone. Although cognitive behavioral therapy for insomnia (CBTi) is an effective treatment for COMISA, previous research suggests a reduced response to CBTi by insomnia patients with depression, anxiety, and stress symptoms. Therefore, we used RCT data to investigate the impact of depression, anxiety, and stress symptoms before treatment on changes in insomnia after CBTi versus control in patients with COMISA.
METHODS


145 patients with COMISA (ICSD-3 insomnia, apnea-hypopnea index ≥ 15 events/h), were randomized to CBTi (n = 72), or no-treatment control (n = 73). One-week sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress were completed pre-treatment and post-treatment. Mixed models were used to examine interactions between depression, anxiety, and stress symptoms before treatment, intervention-group (CBTi, control), and time (pre-, post-treatment) on insomnia symptoms.
RESULTS


Approximately half of this COMISA sample reported at least mild symptoms of depression (57%), anxiety (53%), and stress (48%) before treatment. Patients reporting greater depression, anxiety, and stress symptoms before treatment also reported increased severity of insomnia, daytime fatigue, and sleepiness. Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi, and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction p ≥ 0.11).
CONCLUSIONS


We found no evidence that symptoms of depression, anxiety, or stress impair the effectiveness of CBTi in improving insomnia symptoms in patients with COMISA. Patients with COMISA and comorbid symptoms of depression, anxiety and stress should be referred for CBTi to treat insomnia and improve subsequent management of their OSA.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry, title: Treating comorbid insomnia with obstructive sleep apnoea (COMSIA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, identifier: ACTRN12613001178730, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184.",2020,"Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi, and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction p ≥ 0.11).
","['patients with COMISA', 'patients with either insomnia or sleep apnea alone', 'patients with combined insomnia and sleep apnoea, identifier', 'patients with comorbid insomnia and sleep apnea', 'comorbid insomnia with obstructive sleep apnoea', '145 patients with COMISA (ICSD-3 insomnia, apnea-hypopnea index ≥ 15 events/h', 'Patients with comorbid insomnia and sleep apnea (COMISA', 'Patients with COMISA and comorbid symptoms of depression, anxiety and stress']","['CBTi', 'cognitive behavioral therapy']","['sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress', 'severity of depression, anxiety, or stress symptoms', 'questionnaire and diary-measured insomnia symptoms', 'mild symptoms of depression', 'insomnia symptoms', 'severity of insomnia, daytime fatigue, and sleepiness', 'anxiety', 'depression, anxiety, and stress symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",145.0,0.0286607,"Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi, and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction p ≥ 0.11).
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research (ISSR), The University of Queensland, Queensland, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8944']
1801,33118955,Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice.
OBJECTIVE


This study aims to assess the impact of an SDM training program on nurses' intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training.
METHODS


This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with ""Context and history of prenatal screening,"" and the topic of decision aids in Module 3 was replaced with ""Consent in prenatal screening."" Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training.
RESULTS


This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020.
CONCLUSIONS


Study results will inform us on the impact of an SDM training program on nurses' intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17878.",2020,"They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone.","['French-speaking nurses working with pregnant women in the province of Quebec', 'Pregnant women', 'Data were collected from September 2019 to late January 2020']","['SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone', 'SDM interventions', '3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2', 'SDM training program']",[],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0543432', 'cui_str': 'Problem solving training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0740178', 'cui_str': 'Antenatal screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.112048,"They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Poulin Herron', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Titilayo Tatiana', 'Initials': 'TT', 'LastName': 'Agbadje', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cote', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Roch', 'Affiliation': 'Centre de recherche en santé durable (VITAM), Québec, QC, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rousseau', 'Affiliation': ""Centre Hospitalier Universitaire de Québec - Université Laval Research Centre, Hôpital Saint-François d'Assise, Québec City, QC, Canada.""}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}]",JMIR research protocols,['10.2196/17878']
1802,33109476,A prospective multicenter randomized trial to assess the effectiveness of the magic touch sirolimus-coated balloon in small vessels: Rationale and design of the TRANSFORM I trial.,"AIMS


The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD).
STUDY DESIGN


The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021.
CONCLUSIONS


The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.",2020,"After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon.","['patients with a de-novo SVD', 'small vessels', '114 patients with a de-novo SVD (≤2.5\xa0mm', 'de-novo small vessel coronary artery diseases (SVD']","['SeQuent Please Neo paclitaxel coated balloon (PCB', 'successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis', 'novel SCB balloon or the comparative PCB balloon', 'conventional PCB with a novel OCT measurement approach', 'magic touch sirolimus-coated balloon', 'novel SCB', 'novel Magic Touch sirolimus coated-balloon (SCB']","['efficacy and safety', '6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin', 'Vessel size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",114.0,0.0901843,"After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon.","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Doshi', 'Affiliation': 'Concept Medical Research Private Limited & Envision Scientific Private Limited, Surat, India.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.serruys@nuigalway.ie.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Cortese', 'Affiliation': 'San Carlo Clinic, Milan, Italy; Monasterio Foundation, Tuscany Region, CNR, Pisa, Italy.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.10.004']
1803,33109480,A contemporary neuroscience approach compared to biomedically focused education combined with symptom-contingent exercise therapy in people with chronic whiplash associated disorders: a randomized controlled trial protocol.,"BACKGROUND


To address the need for a better treatment of chronic whiplash associated disorders (WAD), a contemporary neuroscience approach can be proposed.
OBJECTIVE


To examine the effectiveness of a contemporary neuroscience approach, comprising pain neuroscience education, stress management, and cognition-targeted exercise therapy versus conventional physical therapy for reducing disability (primary outcome measure) and improving quality of life and reducing pain, central sensitization, and psychological problems (secondary outcome measures) in people with chronic WAD.
METHODS


The study is a multi-center, two-arm randomized, controlled trial with 1-year follow-up and will be performed in two university-based and one regional hospital. People with chronic WAD (n=120) will be recruited. The experimental group will receive pain neuroscience education followed by cognition-targeted exercise therapy, and stress management. The control group will receive biomedically focused education followed by graded and active exercise therapy focusing on muscle endurance, strength, and flexibility, and ergonomic principles. The treatment will have a duration of 16 weeks. Functional status (Neck Disability Index) is the primary outcome measure. Secondary outcome measures include quality of life, pain, central sensitization, and psychological and socio-economic factors. In addition, electroencephalography will measure brain activity at rest and during a conditioned pain modulation paradigm. Assessments will take place at baseline, immediately post-treatment and at 6 and 12 months follow-up.
CONCLUSIONS


This study will examine whether a contemporary neuroscience approach is superior over conventional physical therapy for improving functioning, quality of life, and reducing pain, central sensitization, and psychological problems in people with chronic WAD.",2020,"This study will examine whether a contemporary neuroscience approach is superior over conventional physical therapy for improving functioning, quality of life, and reducing pain, central sensitization, and psychological problems in people with chronic WAD.","['People with chronic WAD (n=120', 'people with chronic whiplash associated disorders', 'chronic whiplash associated disorders (WAD', 'people with chronic WAD', 'two university-based and one regional hospital']","['education combined with symptom-contingent exercise therapy', 'conventional physical therapy', 'pain neuroscience education followed by cognition-targeted exercise therapy, and stress management', 'contemporary neuroscience approach, comprising pain neuroscience education, stress management, and cognition-targeted exercise therapy versus conventional physical therapy', 'biomedically focused education followed by graded and active exercise therapy focusing on muscle endurance, strength, and flexibility, and ergonomic principles']","['quality of life, pain, central sensitization, and psychological and socio-economic factors', 'quality of life and reducing pain, central sensitization, and psychological problems', 'Functional status (Neck Disability Index', 'functioning, quality of life, and reducing pain, central sensitization, and psychological problems']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205749', 'cui_str': 'Economic Factors'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",120.0,0.129641,"This study will examine whether a contemporary neuroscience approach is superior over conventional physical therapy for improving functioning, quality of life, and reducing pain, central sensitization, and psychological problems in people with chronic WAD.","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Coppieters', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium; Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium. Electronic address: iris.coppieters@vub.be.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Willaert', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Dorine', 'Initials': 'D', 'LastName': 'Lenoir', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Rehabilitation Sciences and Physiotherapy (MOVANT), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cagnie', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ickmans', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium; Research Foundation-Flanders (FWO), 1090 Brussels, Belgium.'}, {'ForeName': 'Anneleen', 'Initials': 'A', 'LastName': 'Malfliet', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium; Research Foundation-Flanders (FWO), 1090 Brussels, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Danneels', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'De Petter', 'Affiliation': 'Sint-Jozefkliniek, Campus Bornem (AZ Rivierenland), Bornem, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.09.004']
1804,33109504,"Pregnant Women Consume a Similar Proportion of Highly vs Minimally Processed Foods in the Absence of Hunger, Leading to Large Differences in Energy Intake.","BACKGROUND


The eating in the absence of hunger (EAH) experimental paradigm measures intake of highly palatable, highly processed foods when sated. However, no studies have examined EAH in pregnant women.
OBJECTIVE


The objectives were to investigate whether EAH in pregnant women differs by level of food processing and to examine relationships of EAH with hedonic hunger, addictive-like eating, and impulsivity.
DESIGN


EAH was assessed in a counterbalanced crossover feeding substudy in which participants completed two free-access eating occasions following a standardized meal during their second pregnancy trimester. Hedonic hunger (Power of Food Scale), addictive-like eating (modified Yale Food Addiction Scale), and impulsivity (Barratt Impulsiveness Scale-15) were assessed by self-report during early pregnancy.
PARTICIPANTS AND SETTING


Data were collected from March 2015 through September 2016 from a subsample of participants (n = 46) enrolled at ≤12 weeks gestation in an observational, prospective cohort study (the Pregnancy Eating Attributes Study) in North Carolina.
INTERVENTION


Participants were presented with highly processed and minimally processed foods in two separate assessments.
MAIN OUTCOME MEASURES


Energy intake (EAH-kcal) and percent consumed (EAH-%) (calculated as 100 × [amount consumed (g) / amount served (g)]) was measured overall and separately for sweet and savory foods.
STATISTICAL ANALYSES PERFORMED


Linear mixed models estimated the effect of condition on EAH. Hedonic hunger, addictive-like eating, impulsivity and their interaction were examined separately.
RESULTS


EAH-% was similar across conditions (16.3% ± 1.1% highly processed vs 17.9% ± 1.2% minimally processed; P = 0.76), resulting in 338.5 ± 34.2 kcal greater energy intake in the highly processed vs minimally processed condition (P < 0.001). Hedonic hunger was not significantly associated with EAH; reward-related eating was positively associated with EAH-kcal and EAH-% of savory foods, and Barratt Impulsivity was positively associated with EAH-kcal and EAH-% overall, and with EAH-% of sweet foods (P < 0.05). There was little evidence of an interaction of Barratt Impulsivity with hedonic hunger or reward-related eating.
CONCLUSIONS


EAH in pregnant women occurs for both highly processed and minimally processed foods and correlates positively with self-reported addictive-like eating, but not hedonic hunger. Impulsivity did not modify associations of addictive-like eating with EAH in this sample.",2020,"Hedonic hunger was not significantly associated with EAH; reward-related eating was positively associated with EAH-kcal and EAH-% of savory foods, and Barratt Impulsivity was positively associated with EAH-kcal and EAH-% overall, and with EAH-% of sweet foods (P < 0.05).","['pregnant women', 'Data were collected from March 2015 through September 2016 from a subsample of participants (n\xa0= 46) enrolled at ≤12 weeks gestation in an observational, prospective cohort study (the Pregnancy Eating Attributes Study) in North Carolina', 'Pregnant Women']",['EAH'],"['Hedonic hunger, addictive-like eating, impulsivity and their interaction', 'Hedonic hunger (Power of Food Scale), addictive-like eating (modified Yale Food Addiction Scale), and impulsivity (Barratt Impulsiveness Scale-15', 'EAH-kcal and EAH-% of savory foods, and Barratt Impulsivity', 'energy intake', 'Hedonic hunger', 'Impulsivity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0475869', 'cui_str': 'Savory food'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",46.0,0.0992377,"Hedonic hunger was not significantly associated with EAH; reward-related eating was positively associated with EAH-kcal and EAH-% of savory foods, and Barratt Impulsivity was positively associated with EAH-kcal and EAH-% overall, and with EAH-% of sweet foods (P < 0.05).","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Lipsky', 'Affiliation': ''}, {'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Myles S', 'Initials': 'MS', 'LastName': 'Faith', 'Affiliation': ''}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Siega-Riz', 'Affiliation': ''}, {'ForeName': 'Aiyi', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Shearrer', 'Affiliation': ''}, {'ForeName': 'Tonja R', 'Initials': 'TR', 'LastName': 'Nansel', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.09.036']
1805,33109643,Cost-effectiveness analysis of a community paramedicine programme for low-income seniors living in subsidised housing: the community paramedicine at clinic programme (CP@clinic).,"OBJECTIVES


To evaluate the cost-effectiveness of the Community Paramedicine at Clinic (CP@clinic) programme compared with usual care in seniors residing in subsidised housing.
DESIGN


A cost-utility analysis was conducted within a large pragmatic cluster randomised controlled trial (RCT). Subsidised housing buildings were matched by sociodemographics and location (rural/urban), and allocated to intervention (CP@clinic for 1 year) or control (usual care) via computer-assisted paired randomisation.
SETTING


Thirty-two subsidised seniors' housing buildings in Ontario.
PARTICIPANTS


Building residents 55 years and older.
INTERVENTION


CP@clinic is a weekly community paramedic-led, chronic disease prevention and health promotion programme in the building common areas. CP@clinic is free to residents and includes risk assessments, referrals to resources, and reports back to family physicians.
OUTCOME MEASURES


Quality-adjusted life years (QALYs) gained, measured with EQ-5D-3L. QALYs were estimated using area-under-the curve over the 1-year intervention, controlling for preintervention utility scores and building pairings. Programme cost data were collected before and during implementation. Costs associated with emergency medical services (EMS) use were estimated. An incremental cost effectiveness ratio (ICER) based on incremental costs and health outcomes between groups was calculated. Probabilistic sensitivity analysis using bootstrapping was performed.
RESULTS


The RCT included 1461 residents; 146 and 125 seniors completed the EQ-5D-3L in intervention and control buildings, respectively. There was a significant adjusted mean QALY gain of 0.03 (95% CI 0.01 to 0.05) for the intervention group. Total programme cost for implementing in five communities was $C128 462 and the reduction in EMS calls avoided an estimated $C256 583. The ICER was $C2933/QALY (bootstrapped mean ICER with Fieller's 95% CI was $4850 ($2246 to $12 396)) but could be even more cost effective after accounting for the EMS call reduction.
CONCLUSION


The CP@clinic ICER was well below the commonly used Canadian cost-utility threshold of $C50 000. CP@clinic scale-up across subsidised housing is feasible and could result in better health-related quality-of-life and reduced EMS use in low-income seniors.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, NCT02152891.",2020,"CP@clinic scale-up across subsidised housing is feasible and could result in better health-related quality-of-life and reduced EMS use in low-income seniors.
","['Building residents 55 years and older', 'low-income seniors living in subsidised housing', 'seniors residing in subsidised housing', ""Thirty-two subsidised seniors' housing buildings in Ontario"", '1461 residents; 146 and 125 seniors completed the']","['EQ-5D-3L', 'Community Paramedicine at Clinic (CP@clinic) programme', 'chronic disease prevention and health promotion programme', 'intervention (CP@clinic for 1\u2009year) or control (usual care) via computer-assisted paired randomisation', 'community paramedicine programme']","['cost-effectiveness', 'incremental costs and health outcomes', 'mean QALY gain', 'ICER', 'Quality-adjusted life years (QALYs) gained, measured with EQ-5D-3L. QALYs', 'CP@clinic ICER', 'Total programme cost', 'incremental cost effectiveness ratio (ICER', 'preintervention utility scores and building pairings']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4520477', 'cui_str': 'Paramedicine'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4520477', 'cui_str': 'Paramedicine'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0645402,"CP@clinic scale-up across subsidised housing is feasible and could result in better health-related quality-of-life and reduced EMS use in low-income seniors.
","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada gina.agarwal@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pirrie', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Angeles', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Marzanek', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-037386']
1806,33109654,Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial.,"INTRODUCTION


Evidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.
METHODS AND ANALYSIS


This ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow-ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10 ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses.
ETHICS AND DISSEMINATION


This protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry NCT03565796.",2020,"This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.
","['University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number', 'enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong', 'community smokers']","['active referral combined with a financial incentive to use smoking cessation services', 'active referral combined with a small financial incentive', 'referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months']","['smoking abstinence', 'bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10\u2009ng/mL', 'self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.287369,"This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.
","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China mpwang@hku.hk.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ching Yin', 'Initials': 'CY', 'LastName': 'Lau', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Antonio Cho Shing', 'Initials': 'ACS', 'LastName': 'Kwong', 'Affiliation': 'Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Vienna Wai Yin', 'Initials': 'VWY', 'LastName': 'Lai', 'Affiliation': 'Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Sophia Siu Chee', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong, China.'}]",BMJ open,['10.1136/bmjopen-2020-038351']
1807,33109658,A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).,"INTRODUCTION


Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit.
METHODS AND ANALYSIS


The economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34-38 weeks gestation and 6 months postpartum. The long-term model will be informed by data from the trial and published literature.
ETHICS AND DISSEMINATION


TRIAL REGISTRATION NUMBER: ISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).",2020,"Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age.",['pregnant women to quit'],['usual care or usual care plus up to £400 financial incentives'],"['Smoking prevalence', 'health costs', 'risk of premature birth']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",,0.170335,"Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK nicola.mcmeekin@glasgow.ac.uk.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Sinclair', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David Michael', 'Initials': 'DM', 'LastName': 'Tappin', 'Affiliation': 'Scottish Cot Death Trust, West Glasgow Ambulatory Care Hospital, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kathleen Anne', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038827']
1808,33109663,Effects of oil-soluble versus water-soluble contrast media at hysterosalpingography on pregnancy outcomes in women with a low risk of tubal disease: study protocol for a randomised controlled trial.,"INTRODUCTION


In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG.
METHODS AND ANALYSIS


This study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups.
ETHICS AND DISSEMINATION


This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER


ChiCTR2000031612.",2020,"In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age.","['Patients with low risk of tubal disease', '520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation', 'women with a low risk of tubal disease', 'Chinese women undergoing HSG']","['oil-soluble versus water-soluble contrast media at hysterosalpingography', 'HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media', 'OSCM', 'Hysterosalpingography (HSG']","['rate of ongoing pregnancy', 'pregnancy outcomes', 'rates of pregnancy', 'thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0444757', 'cui_str': 'Water soluble contrast medium'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",,0.288178,"In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age.","[{'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China.'}, {'ForeName': 'Chenfeng', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-039166']
1809,33109777,"Kegel Exercises, Biofeedback, Electrostimulation, and Peripheral Neuromodulation Improve Clinical Symptoms of Fecal Incontinence and Affect Specific Physiological Targets: An Randomized Controlled Trial.","Background/Aims


Fecal incontinence (FI) is a prevalent condition among community-dwelling women, and has a major impact on quality of life (QoL). Research on treatments commonly used in clinical practice-Kegel exercises, biofeedback, electrostimulation, and transcutaneous neuromodulation-give discordant results and some lack methodological rigor, making scientific evidence weak. The aim is to assess the clinical efficacy of these 4 treatments on community-dwelling women with FI and their impact on severity, QoL and anorectal physiology.
Methods


A randomized controlled trial was conducted on 150 females with FI assessed with anorectal manometry and endoanal ultrasonography, and pudendal nerve terminal motor latency, anal/rectal sensory-evoked-potentials, clinical severity, and QoL were determined. Patients were randomly assigned to one of the following groups: Kegel (control), biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel, treated for 3 months and reevaluated, then followed up after 6 months.
Results


Mean age was 61.09 ± 12.17. Severity of FI and QoL was significantly improved in a similar way after all treatments. The effect on physiology was treatment-specific: Kegel and electrostimulation + Kegel, increased resting pressure ( P  < 0.05). Squeeze pressures strongly augmented with biofeedback + Kegel, electrostimulation + Kegel and neuromodulation + Kegel ( P  < 0.01). Endurance of squeeze increased in biofeedback + Kegel and electrostimulation + Kegel ( P  < 0.01). Rectal perception threshold was reduced in the biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel ( P  < 0.05); anal sensory-evoked-potentials latency shortened in patients with electrostimulation + Kegel ( P  < 0.05).
Conclusions


The treatments for FI assessed have a strong and similar efficacy on severity and QoL but affect specific pathophysiological mechanisms. This therapeutic specificity can help to develop more efficient multimodal algorithm treatments for FI based on pathophysiological phenotypes.",2020,"Rectal perception threshold was reduced in the biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel ( P  < 0.05); anal sensory-evoked-potentials latency shortened in patients with electrostimulation + Kegel ( P  < 0.05).
","['community-dwelling women', 'community-dwelling women with FI and their impact on severity, QoL and anorectal physiology', '150 females with FI assessed with anorectal manometry and endoanal ultrasonography, and pudendal nerve terminal motor latency, anal/rectal sensory-evoked-potentials, clinical severity, and QoL were determined']","['Kegel (control), biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel', 'Kegel Exercises, Biofeedback, Electrostimulation, and Peripheral Neuromodulation Improve']","['clinical efficacy', 'Severity of FI and QoL', 'Endurance of squeeze', 'resting pressure', 'Rectal perception threshold', 'anal sensory-evoked-potentials latency']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]","[{'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",150.0,0.0794002,"Rectal perception threshold was reduced in the biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel ( P  < 0.05); anal sensory-evoked-potentials latency shortened in patients with electrostimulation + Kegel ( P  < 0.05).
","[{'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mundet', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Mataró, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Rofes', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Mataró, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ortega', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Mataró, Spain.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabib', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Mataró, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Mataró, Spain.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20013']
1810,33109859,Effect of Opioid Versus Non-Opioid Analgesia on Surgical Pleth Index and Biomarkers of Surgical Stress During Neurosurgery for Brain Tumors: Preliminary Findings.,"Background


Stress response to surgery is mediated by the sympathetic nervous system and manifests as changes in hemodynamic and neuroendocrine parameters. Recently, the surgical pleth index (SPI) is employed for objective and continuous monitoring of nociceptive response during surgery. Opioids are the mainstay of managing stress response to nociception during the perioperative period. However, due to the well-known adverse effects of opioids, α2 agonists are increasingly used to ablate stress response and reduce opioid usage.
Objectives


This study compared SPI and biomarkers of surgical stress between opioid (fentanyl) and non-opioid (dexmedetomidine) analgesia during craniotomy.
Methods


Patients aged 18 to 60 years undergoing elective craniotomies for brain tumor resection under general anesthesia were randomized to receive fentanyl 1 μg/kg/h or dexmedetomidine 0.5 μ/kg/h infusion as the primary intraoperative analgesic. Our objective was to compare SPI and biomarkers of surgical stress-serum cortisol, blood glucose, arterial pH, and leucocyte count between the two groups.
Results


Data of all 24 patients recruited into the study were analyzed. There was no difference in the demographic parameters between the groups. The SPI remained similar with both the drugs over various time points during the study period. There was no difference between the groups in the biomarkers of surgical stress-cortisol, blood glucose, and pH while leucocyte count was higher in the fentanyl group.
Conclusions


The stress response to surgery during craniotomy for brain tumors is similar with opioid (fentanyl) and non-opioid (dexmedetomidine) analgesia as assessed by SPI and blood markers such as cortisol, glucose, and pH.",2020,"There was no difference between the groups in the biomarkers of surgical stress-cortisol, blood glucose, and pH while leucocyte count was higher in the fentanyl group.
","['Brain Tumors', 'Patients aged 18 to 60 years undergoing elective craniotomies for brain tumor resection under general anesthesia', '24 patients recruited into the study were analyzed']","['opioid (fentanyl) and non-opioid (dexmedetomidine) analgesia', 'Opioid Versus Non-Opioid Analgesia', 'fentanyl 1 μg/kg/h or dexmedetomidine']","['biomarkers of surgical stress-cortisol, blood glucose, and pH while leucocyte count', 'demographic parameters', 'SPI and biomarkers of surgical stress-serum cortisol, blood glucose, arterial pH, and leucocyte count', 'Surgical Pleth Index and Biomarkers of Surgical Stress']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}]",24.0,0.0241717,"There was no difference between the groups in the biomarkers of surgical stress-cortisol, blood glucose, and pH while leucocyte count was higher in the fentanyl group.
","[{'ForeName': 'Kamath', 'Initials': 'K', 'LastName': 'Sriganesh', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Seham', 'Initials': 'S', 'LastName': 'Syeda', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Shanthanna', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Venkataramaiah', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Sangeetha R', 'Initials': 'SR', 'LastName': 'Palaniswamy', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}]",Neurology India,['10.4103/0028-3886.294559']
1811,33109892,"Response to Article ""A Comparison of Hypertonic Saline (HTS) and Mannitol on Intraoperative Brain Relaxation in Patients with Raised Intracranial Pressure During Supratentorial Tumors Resection: A Randomized Control Trial"".",,2020,,"['Patients with Raised Intracranial Pressure', 'During Supratentorial Tumors Resection']",['Hypertonic Saline (HTS) and Mannitol'],['Intraoperative Brain Relaxation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0038874', 'cui_str': 'Neoplasms, Supratentorial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.0925056,,"[{'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Sarkar', 'Affiliation': 'Senior Consultant, Neurosurgery, Department of Neurosciences, Kokilaben Dhirubhai Ambani Hospital, Mumbai, Maharashtra, India.'}]",Neurology India,['10.4103/0028-3886.299166']
1812,33109893,"In Reply to the Response to Article ""A Comparison of Hypertonic Saline (HTS) and Mannitol on Intraoperative Brain Relaxation in Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection: A Randomized Control Trial"".",,2020,,['Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection'],['Hypertonic Saline (HTS) and Mannitol'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0038874', 'cui_str': 'Neoplasms, Supratentorial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]",[],,0.0764808,,"[{'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Jangra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ankush', 'Initials': 'A', 'LastName': 'Singla', 'Affiliation': 'Department of Anaesthesia, Adesh Medical College, Bhathinda, Punjab, India.'}, {'ForeName': 'Preethy J', 'Initials': 'PJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Neurology India,['10.4103/0028-3886.299135']
1813,33109923,"Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study.","BACKGROUND


Trauma-induced coagulopathy (TIC) substantially contributes to mortality in bleeding trauma patients.
OBJECTIVE


The aim of the study was to administer fibrinogen concentrate in the prehospital setting to improve blood clot stability in trauma patients bleeding or presumed to bleed.
DESIGN


A prospective, randomised, placebo-controlled, double-blinded, international clinical trial.
SETTING


This emergency care trial was conducted in 12 Helicopter Emergency Medical Services (HEMS) and Emergency Doctors' vehicles (NEF or NAW) and four trauma centres in Austria, Germany and Czech Republic between 2011 and 2015.
PATIENTS


A total of 53 evaluable trauma patients aged at least 18 years with major bleeding and in need of volume therapy were included, of whom 28 received fibrinogen concentrate and 25 received placebo.
INTERVENTIONS


Patients were allocated to receive either fibrinogen concentrate or placebo prehospital at the scene or during transportation to the study centre.
MAIN OUTCOME MEASURES


Primary outcome was the assessment of clot stability as reflected by maximum clot firmness in the FIBTEM assay (FIBTEM MCF) before and after administration of the study drug.
RESULTS


Median FIBTEM MCF decreased in the placebo group between baseline (before administration of study treatment) and admission to the Emergency Department, from a median of 12.5 [IQR 10.5 to 14] mm to 11 [9.5 to 13] mm (P = 0.0226), but increased in the FC Group from 13 [11 to 15] mm to 15 [13.5 to 17] mm (P = 0.0062). The median between-group difference in the change in FIBTEM MCF was 5 [3 to 7] mm (P < 0.0001). Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g l throughout the observation period.
CONCLUSION


Early fibrinogen concentrate administration is feasible in the complex and time-sensitive environment of prehospital trauma care. It protects against early fibrinogen depletion, and promotes rapid blood clot initiation and clot stability.
TRIAL REGISTRY NUMBERS


EudraCT: 2010-022923-31 and ClinicalTrials.gov: NCT01475344.",2020,Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g ,"['53 evaluable trauma patients aged at least 18 years with major bleeding and in need of volume therapy', 'trauma patients bleeding or presumed to bleed (FIinTIC', 'bleeding trauma patients', 'trauma patients bleeding or presumed to bleed', ""12 Helicopter Emergency Medical Services (HEMS) and Emergency Doctors' vehicles (NEF or NAW) and four trauma centres in Austria, Germany and Czech Republic between 2011 and 2015""]","['fibrinogen concentrate', 'fibrinogen concentrate or placebo prehospital', 'placebo', 'fibrinogen concentrate and 25 received placebo', 'EudraCT']","['Median FIBTEM MCF', 'assessment of clot stability as reflected by maximum clot firmness in the FIBTEM assay (FIBTEM MCF', 'change in FIBTEM MCF', 'Median fibrinogen plasma concentrations', 'blood clot stability']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0206183', 'cui_str': 'Emergency Helicopters'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008015', 'cui_str': 'Macrophage chemotactic factor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}]",,0.618819,Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g ,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ziegler', 'Affiliation': 'From the Department of Anaesthesiology, Perioperative Medicine and General Intensive Care Medicine, Paracelsus Medical University, Salzburg (BZ), Department of General and Surgical Critical Care Medicine, (MB, BS, DF ), Department of Anaesthesiology and Intensive Care Medicine (HH, PI, MK, EO, MT, BT), Department of Pediatrics, Pediatrics I, Intensive Care Unit, Medical University of Innsbruck, Innsbruck (CN), Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, University of Innsbruck, Technikerstrasse, Austria (TH), Department of Trauma and Orthopedic Surgery, Cologne-Merheim Medical Center (CMMC), University Witten/Herdecke (UW/H), Campus Cologne-Merheim, Cologne, Germany (MM), Institute of Thrombosis and Haemostasis and the National Haemophilia Centre, The Chaim Sheba Medical Centre, Tel Hashomer, Israel (UM), Sportclinic Zillertal GmbH, Mayrhofen, Austria (CN), Department of Anaesthesiology and Intensive Care Medicine, AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University, Salzburg, Austria (HS, WV), Department of Anesthesiology and Intensive Care, Liberec Regional Hospital, Liberec, Czech Republic (IZ), Christophorus 14, Niederöblarn, Austria (CW).'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Bachler', 'Affiliation': ''}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Haberfellner', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Niederwanger', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Innerhofer', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hell', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kaufmann', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maegele', 'Affiliation': ''}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Martinowitz', 'Affiliation': ''}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Nebl', 'Affiliation': ''}, {'ForeName': 'Elgar', 'Initials': 'E', 'LastName': 'Oswald', 'Affiliation': ''}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Schöchl', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Schenk', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Thaler', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Treichl', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Voelckel', 'Affiliation': ''}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Zykova', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wimmer', 'Affiliation': ''}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fries', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001366']
1814,33110607,Effects of maximal strength training on bone mineral density in people living with HIV and receiving anti-retroviral therapy: a pilot study.,"Background


Anti-retroviral therapy (ART) is associated with low bone mineral density (BMD) among people living with HIV (PLWHIV). Although physical activity is recommended for improving bone health in patients with reduced BMD, data on effects of strength exercises on low BMD among PLWHIV is scarce. This study therefore aimed to determine the effects of a 12 weeks maximal strength training (MST) on BMD among PLWHIV in Blantyre, Malawi.
Methods


Twenty-six PLWHIV with reduced BMD were randomised into a training group (TG,  n  = 15) and control group (CG,  n  = 11). The TG underwent 12 weeks of MST consisting of 4 sets of 3 to 5 repetitions at 85-90% of one repetition maximum (1RM) 3 times per week. The CG was advised to maintain their usual lifestyle. Measurements of BMD using dual-energy X-ray absorptiometry, 1RM using a squat machine, heart rate using a heart rate monitor, weight, height and body mass index were obtained before and after the intervention in the TG and CG. Descriptive statistics and student's t - tests were used to analyse data.
Results


The study was conducted for 12 weeks. Data of 24 participants [14 (TG) and 10 (CG)] were analysed. At base line, there were no significant differences in age ( p  = 0.34), height ( p  = 0.91), weight ( p  = 0.43) and body mass index ( p  = 0.34) between participants in the TG and the CG. After the intervention, there were significant improvements in lumbar BMD ( p  < 0.001) and resting heart rate ( p  = 0.03) in the TG compared to the CG. There were significant improvements in muscle strength (1 RM) in both the TG ( p  < 0.001) and the CG ( p  = 0.01).
Conclusions


MST improves lumbar BMD and strength in PLWHIV receiving ART in Blantyre, Malawi. MST with a shorter exercise duration of 12 weeks seem to have the potential in treating reduced BMD in PLWHIV.
Trial registration


PACTR201712002889203. Registered with the Pan African Clinical Trial Registry on 22nd December, 2017 at www. pactr.org.",2020,"There were significant improvements in muscle strength (1 RM) in both the TG ( p  < 0.001) and the CG ( p  = 0.01).
","['24 participants [14 (TG) and 10 (CG', 'people living with HIV and receiving anti-retroviral therapy', 'Methods\n\n\nTwenty-six PLWHIV with reduced BMD', 'patients with reduced BMD', 'people living with HIV (PLWHIV']","['\n\n\nAnti-retroviral therapy (ART', '12\u2009weeks maximal strength training (MST', 'maximal strength training', 'MST']","['bone mineral density', 'weight', 'muscle strength (1 RM', 'body mass index', 'lumbar BMD', 'low bone mineral density (BMD', 'resting heart rate', 'lumbar BMD and strength', 'squat machine, heart rate using a heart rate monitor, weight, height and body mass index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0313322,"There were significant improvements in muscle strength (1 RM) in both the TG ( p  < 0.001) and the CG ( p  = 0.01).
","[{'ForeName': 'Enock M', 'Initials': 'EM', 'LastName': 'Chisati', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Demitri', 'Initials': 'D', 'LastName': 'Constantinou', 'Affiliation': 'Center for Exercise Science and Sports Medicine, FIMS Collaborating Center of Sports Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Fanuel', 'Initials': 'F', 'LastName': 'Lampiao', 'Affiliation': 'Department of Biomedical Sciences, College of Medicine, University of Malawi, Blantyre, Malawi.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00216-6']
1815,33110614,Text message reminders as an adjunct to a substance use intervention for adolescents and young adults: Pilot feasibility and acceptability findings.,"Objective


Text messaging has been proposed as a method for increasing the reach of interventions for harmful alcohol and other drug use. This paper describes the design of an automated text messaging adjunct to a substance use intervention intended to support adolescents and young adults attempting to change their alcohol and other drug use behavior. Feasibility and acceptability testing was conducted as part of this pilot study.
Method


Five focus groups were conducted to refine text message content and finalize pilot intervention design. Automated, daily, substance use-related reminder text messages were sent to pilot intervention participants ( n =  39), who were recruited from outpatient treatment.
Results


Of those who were invited, 63% enrolled in the study and 89.7% remained enrolled in the study as measured by completing at least one assessment after baseline. Participants reported a positive experience with the messages, particularly supportive/empowering messages and commitment reminder messages.
Conclusions


These findings suggest that text messaging is a feasible and acceptable method for delivery of substance use-related reminder content as an adjunct to substance use intervention.",2020,"Automated, daily, substance use-related reminder text messages were sent to pilot intervention participants ( n =  39), who were recruited from outpatient treatment.
",['adolescents and young adults'],['substance use intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],63.0,0.0654646,"Automated, daily, substance use-related reminder text messages were sent to pilot intervention participants ( n =  39), who were recruited from outpatient treatment.
","[{'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, Center for the Study of Health and Risk Behaviors, University of Washington, Seattle, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychology, Center for the Study of Health and Risk Behaviors, University of Washington, Seattle, USA.'}]",Digital health,['10.1177/2055207620965052']
1816,33110622,Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot feasibility dose evaluation randomized controlled trial.,"Background


The vast majority of children undergoing cardiac surgery have low vitamin D levels post-operative, which may contribute to greater illness severity and worse clinical outcomes. Prior to the initiation of a large phase III clinical trial focused on clinical outcomes, studies are required to evaluate the feasibility of the study protocol, including whether the proposed dosing regimen can safely prevent post-operative vitamin D deficiency in this high-risk population.
Methods


We conducted a two-arm, double-blind dose evaluation randomized controlled trial in children requiring cardiopulmonary bypass for congenital heart disease. Pre-operatively, participants were randomized to receive cholecalciferol representing usual care (< 1 year = 400 IU/day, > 1 year = 600 IU/day) or a higher dose approximating the Institute of Medicine tolerable upper intake level (< 1 year = 1600 IU/day, > 1 year = 2400 IU/day). The feasibility outcomes were post-operative vitamin D status (primary), vitamin D-related adverse events, accrual rate, study withdrawal rate, blinding, and protocol non-adherence.
Results


Forty-six children were randomized, and five withdrew prior to surgery, leaving 41 children (21 high dose, 20 usual care) in the final analysis. The high dose group had higher 25-hydroxyvitamin D concentrations both intraoperatively (mean difference + 25.9 nmol/L; 95% CI 8.3-43.5) and post-operatively (mean difference + 17.2 nmol/L; 95% CI 5.5-29.0). Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50 nmol/L, compared with usual care (RR 0.31, 95% CI 0.11-0.87). Post-operative vitamin D status was associated with the treatment arm and the number of doses received. There were no cases of hypercalcemia, and no significant adverse events related to vitamin D. While only 75% of the target sample size was recruited (limited funding), the consent rate (83%), accrual rate (1.5 per site month), number of withdrawals (11%), and ability to maintain blinding support feasibility of a larger trial.
Conclusions


Pre-operative daily high-dose supplementation improved vitamin D status pre-operatively and at time of pediatric ICU admission. The protocol for a more definitive trial should limit enrollment of children with at least 30 days between randomization and surgery to allow adequate duration of supplementation or consider a loading dose.
Trial registration


ClinicalTrials.gov, NCT01838447. Registered on April 24, 2013.",2020,"Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50 nmol/L, compared with usual care (RR 0.31, 95% CI 0.11-0.87).","['protocol non-adherence.\nResults\n\n\nForty-six children', 'children requiring cardiopulmonary bypass for congenital heart disease', 'children with congenital heart disease']","['cholecalciferol representing usual care', 'post-cardiac surgery vitamin D deficiency']","['25-hydroxyvitamin D concentrations', 'post-operative serum 25-hydroxyvitamin D concentrations', 'operative vitamin D status (primary), vitamin D-related adverse events, accrual rate, study withdrawal rate, blinding, and', 'hypercalcemia', 'vitamin D status', 'accrual rate']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}]",46.0,0.630668,"Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50 nmol/L, compared with usual care (RR 0.31, 95% CI 0.11-0.87).","[{'ForeName': 'James Dayre', 'Initials': 'JD', 'LastName': 'McNally', 'Affiliation': 'Department of Pediatrics, Division of Critical Care, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': ""O'Hearn"", 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.""}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lougheed', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Dermot R', 'Initials': 'DR', 'LastName': 'Doherty', 'Affiliation': ""Children's Health Ireland at Temple Street, Dublin, Ireland.""}, {'ForeName': 'Gyaandeo', 'Initials': 'G', 'LastName': 'Maharajh', 'Affiliation': 'Department of Pediatric Surgery, Division of Cardiovascular Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Weiler', 'Affiliation': 'School of Human Nutrition, Faculty of Agricultural and Environmental Sciences, McGill University, Montreal, Canada.'}, {'ForeName': 'Glenville', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': ""School of Medicine, Department of Biomedical and Molecular Sciences, Queen's University, Kingston, Canada.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khamessan', 'Affiliation': 'Euro-Pharm International Canada Inc., Montreal, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Redpath', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Geier', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Lauralyn', 'Initials': 'L', 'LastName': 'McIntyre', 'Affiliation': 'Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Girolamo', 'Affiliation': 'Department of Pediatric Surgery, Division of Cardiovascular Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Menon', 'Affiliation': 'Department of Pediatrics, Division of Critical Care, University of Ottawa, Ottawa, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-020-00700-3']
1817,33110623,Examining recruitment feasibility and related outcomes in adults post-stroke.,"Background


There are limited effective and evidence-based interventions for upper extremity hemiparesis post-stroke. To prepare for an RCT and minimize misuse of resources, there is value in conducting a feasibility study.
Objective


To examine the feasibility of recruitment and other related outcomes for an intense upper limb intervention.
Methodology


Feasibility outcomes included retention, adherence, accrual rate, sample characteristics, and identification of productive recruitment methods. Other outcomes included satisfaction with the study, fidelity, and equipoise of both staff and participants.
Results


Participants were enrolled at a rate of 1.33 per month. The recruitment timeline had to be extended by 4 months, to meet the target of 16 randomized participants. Staggered recruitment was the most successful strategy. We found that following up with individuals who missed initial appointments prior to study enrollment led to decreased adherence.
Conclusion


It is feasible to recruit and retain post-stroke participants for an intense intervention study.
Trial registration


NCT02277028.",2020,Staggered recruitment was the most successful strategy.,['adults post-stroke'],[],"['satisfaction with the study, fidelity, and equipoise of both staff and participants', 'retention, adherence, accrual rate, sample characteristics, and identification of productive recruitment methods']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",16.0,0.25736,Staggered recruitment was the most successful strategy.,"[{'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'King', 'Affiliation': 'Interdepartmental Neuroscience Program, Northwestern University, 645\u2009N Michigan Ave, STE 1100, Chicago, IL 60611 USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Swedish Medical Center, Englewood, Colorado USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Corcos', 'Affiliation': 'Northwestern University, Chicago, Illinois USA.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Stoykov', 'Affiliation': 'Northwestern University, Chicago, Illinois USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00696-w']
1818,33110649,The  Bacillus  Calmette-Guérin (BCG) Vaccine: Is it a better choice for the treatment of viral warts?,"Objectives


This study aimed to compare the effectiveness of the  bacillus  Calmette-Guérin (BCG) vaccine with topical salicylic acid (SA) in the treatment of viral warts.
Methods


This non-randomised controlled trial was conducted at the Al-Sader Teaching Hospital, Basrah, Iraq, from January 2016 to April 2017. A total of 201 patients with viral warts were injected with an intradermal purified protein derivative. Subsequently, those with negative tuberculin test results received an intradermal BCG vaccination, while those with positive results underwent conventional treatment with topical SA. Patients were assessed for any signs of improvement at one, two and three months.
Results


Overall, 190 patients completed the trial; of these, 133 (70%) received the BCG vaccine and 57 (30%) were treated with topical SA. Complete response to treatment was observed in 9.8% and 5.3% of patients in the BCG and SA groups, respectively ( P  <0.001). Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041). A binary logistic regression analysis indicated that BCG therapy was the only significant independent predictor of positive treatment response (odds ratio: 7.56, 95% confidence interval: 3.72-15.36;  P  <0.001).
Conclusion


The BCG vaccine was more effective than topical SA for treating viral warts, with the best response noted in the treatment of genital warts, followed by flat warts. However,  plantar  warts demonstrated least response to this treatment.",2020,"Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041).","['Al-Sader Teaching Hospital, Basrah, Iraq, from January 2016 to April 2017', '201 patients with viral warts', '190 patients completed the trial; of these, 133 (70%) received the']","['conventional treatment with topical SA', 'BCG vaccine', 'topical SA', 'Guérin (BCG) Vaccine', 'bacillus  Calmette-Guérin (BCG) vaccine with topical salicylic acid (SA', 'intradermal BCG vaccination', 'intradermal purified protein derivative']","['Cure rates', 'positive treatment response', 'Complete response to treatment']","[{'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3212023', 'cui_str': 'Salicylic acid-containing product in cutaneous dose form'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1275810', 'cui_str': 'Complete therapeutic response'}]",201.0,0.0875421,"Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041).","[{'ForeName': 'Asaad Q', 'Initials': 'AQ', 'LastName': 'Al-Yassen', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}, {'ForeName': 'Shukrya K', 'Initials': 'SK', 'LastName': 'Al-Maliki', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}, {'ForeName': 'Jasim N', 'Initials': 'JN', 'LastName': 'Al-Asadi', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}]",Sultan Qaboos University medical journal,['10.18295/squmj.2020.20.03.013']
1819,33119068,Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 randomized clinical trial in the Russian Federation.,"BACKGROUND


This study compares the immunogenicity and safety of a 3-antigen (S/preS1/preS2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia.
METHODS


Randomized, double-blind, comparative study of three-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18-45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at Days 1, 28, 90, 180 and 210, adverse and serious adverse events (SAEs) to Study Day 210. The primary outcome was based on the difference in rates of seroconversion at Day 210 (lower bound 95% CI > - 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs >10 mIU/mL and anti-HBs geometric mean concentration (GMC).
RESULTS


Rate of seroconversion in 3AV (100%) was non-inferior to 1AV (97.9%) at Study Day 210 [Difference: 2.1%, 95% CI: -2.0, 6.3%] but significantly higher at Study Day 28. SPR at Study Day 210 was >97% in both arms. Anti-HBs titers were significantly higher at Study Days 90 (p = 0.001) and 180 (p = 0.0001) with 3AV. Sex, age, and BMI had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, p = 0.15), second (20.0% vs 14.6%, p = 0.33) and third vaccination (14.9% vs 23.4%, p = 0.22). No SAEs were reported.
CONCLUSIONS


3AV was non-inferior to 1AV. 3AV induced high SPR and there were no safety concerns.",2020,Anti-HBs titers were significantly higher at Study Days 90 (p = 0.001) and 180 (p = 0.0001) with 3AV.,"['adults aged 18-45 years', 'adults to support the registration of 3AV in Russia']","['3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine', '3-antigen (S/preS1/preS2) hepatitis B (HepB) vaccine (3AV', '3AV (10 μg) and 1AV']","['Anti-HBs titers', 'seroprotection rates (SPR), defined as anti-HBs >10 mIU/mL and anti-HBs geometric mean concentration (GMC', 'Efficacy and Safety', 'rates of seroconversion', 'hepatitis B surface (HBs) antibody titers', 'rates of local reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}]",,0.377046,Anti-HBs titers were significantly higher at Study Days 90 (p = 0.001) and 180 (p = 0.0001) with 3AV.,"[{'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Esaulenko', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation.'}, {'ForeName': 'Aleksey A', 'Initials': 'AA', 'LastName': 'Yakovlev', 'Affiliation': 'St Petersburg State Budgetary Healthcare Institution; S.P. Botkin Clinical Infectious Diseases Hospital.'}, {'ForeName': 'Genady A', 'Initials': 'GA', 'LastName': 'Volkov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo).'}, {'ForeName': 'Anastasia A', 'Initials': 'AA', 'LastName': 'Sukhoruk', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education; Saint Petersburg State Paediatric Medical University of the Ministry of Health of the Russian Federation.'}, {'ForeName': 'Kirill G', 'Initials': 'KG', 'LastName': 'Surkov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo).'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Kruglyakov', 'Affiliation': 'Pharmsynthez PAO (Publichnoye Aktsionernoye Obshchestvo).'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diaz-Mitoma', 'Affiliation': 'VBI Vaccines Inc., Cambridge, Massachusetts, United States.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1649']
1820,33119121,"Mindfulness-Based Stress Reduction for Stress, Anxiety, and Psychological Well-Being: Effects in a Republic of Korea Navy Fleet Crew.","The purpose of the current study was to investigate the effects of a mindfulness-based stress reduction (MBSR) program on perceived stress, depression, anxiety, and psychological well-being of a Republic of Korea (ROK) Navy fleet crew. A quasi-experimental study with a non-equivalent control group pretest/post-test design was used. Participants were randomized to an experimental group (n = 18) and control group (n = 21). The experimental group received MBSR for 90 minutes per week for eight sessions. Data were analyzed using descriptive statistics and Shapiro-Wilk, chi-square, Mann-Whitney U, and t tests. Results showed significant decreases in perceived stress (t = -8.24, p = 0.015) and anxiety (t = -0.25, p = 0.041) and improved psychological well-being (t = 2.58, p = 0.023) in the experimental group compared to the control group. No differences were found for depression between groups. These findings indicate that MBSR was effective in addressing perceived stress, anxiety, and psychological well-being of a ROK Navy fleet crew. This study suggests MBSR can be expanded to other populations at high risk for stress and anxiety. [Journal of Psychosocial Nursing and Mental Health Services, 58(11), 48-55.].",2020,"Results showed significant decreases in perceived stress (t = -8.24, p = 0.015) and anxiety (t = -0.25, p = 0.041) and improved psychological well-being (t = 2.58, p = 0.023) in the experimental group compared to the control group.",['Republic of Korea Navy Fleet Crew'],"['MBSR', 'mindfulness-based stress reduction (MBSR) program']","['perceived stress, depression, anxiety, and psychological well-being of a Republic of Korea (ROK) Navy fleet crew', 'anxiety', 'perceived stress']","[{'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]",,0.0115284,"Results showed significant decreases in perceived stress (t = -8.24, p = 0.015) and anxiety (t = -0.25, p = 0.041) and improved psychological well-being (t = 2.58, p = 0.023) in the experimental group compared to the control group.","[{'ForeName': 'Hyekyung', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Jeong-Bok', 'Initials': 'JB', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'In-Young', 'Initials': 'IY', 'LastName': 'Hwang', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20201013-06']
1821,33119135,The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes.,"AIMS


Postprandial glycaemic variability carries on being a clinical challenge in optimizing glucose control in type 1 diabetes. The aim of this study was to compare the postprandial glycaemic effects of carbohydrate counting and food insulin index algorithms following the consumption of protein-rich, high-fat meals with different glycaemic index (GI) in adolescents with type 1 diabetes.
METHODS


A randomized, single-blind and crossover trial included 15 adolescents aged 14-18 years with type 1 diabetes. Participants consumed two different test meals with similar energy, macronutrients, and food insulin index but the approximately two-fold difference in GI, in random order on four consecutive mornings at their home. Insulin dose for high- and low-GI test meals were determined by using the carbohydrate counting and food insulin index algorithms. Four-hours postprandial glycaemia was assessed by continuous glucose monitoring system.
RESULTS


Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between two algorithms in the low-GI meal. The occurrence of hypoglycaemia did not significantly differ between insulin dosing algorithms for the high-GI (p = 0.58) and low-GI (p = 0.20) meals.
CONCLUSIONS


The food insulin index algorithm may be beneficial for postprandial glycaemic control after the consumption of high-GI meals in adolescents with type 1 diabetes.",2020,"Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between two algorithms in the low-GI meal.","['15 adolescents aged 14-18 years with type 1 diabetes', 'adolescents with type 1 diabetes', 'type 1 diabetes']","['food insulin index algorithm', 'carbohydrate counting and food insulin index algorithms']","['coefficient variation of blood glucose', 'postprandial glycaemia', 'incremental area under the curve', 'occurrence of hypoglycaemia', 'peak glucose excursion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",15.0,0.0471502,"Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between two algorithms in the low-GI meal.","[{'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Erdal', 'Affiliation': 'Erciyes University, Institute of Health Sciences, Department of Nutrition and Dietetics, Kayseri, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Caferoglu', 'Affiliation': 'Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Kayseri, Turkey.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Hatipoglu', 'Affiliation': 'Erciyes University, Faculty of Medicine, Department of Paediatric Endocrinology, Kayseri, Turkey.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14444']
1822,33119142,Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk.,"BACKGROUND


Decision support tools improve decisional conflict and elicit patient preferences related to prostate cancer treatment. It was hypothesized that men using the Personal Patient Profile-Prostate (P3P) would be more likely to pursue guideline-concordant treatment.
METHODS


Men from a trial assessing the P3P decision support intervention were identified. The primary exposure was allocation to P3P (vs usual care), and the outcome was appropriate treatment per guidelines (eg, low risk = active surveillance). It was assessed whether providers recommended against any treatment options (ie, restricted). A multivariable model was fit for men with low-risk cancer that estimated the odds of the outcome of interest.
RESULTS


This study identified 295 men in the cohort: 113 (38%) had low-risk disease, 119 (40%) had favorable intermediate-risk disease, and 63 (21%) had unfavorable intermediate-risk disease. Among low-risk patients, more men pursued active surveillance after using P3P whether they were given unrestricted (62% vs 54% with usual care; P = .54) or restricted options (71% vs 59% with usual care; P = .34). After adjustments, only Black race (odds ratio [OR], 0.31; 95% CI, 0.11-0.89) and restricted options (OR, 0.23; 95% CI, 0.08-0.65) had an inverse association with the receipt of surveillance for patients with low-risk prostate cancer. An impact associated with P3P versus usual care (OR, 0.89; 95% CI, 0.36-2.20) was not observed.
CONCLUSIONS


Among men in a trial assessing a decision support tool, Black race and restricted treatment options were associated with less use of active surveillance for low-risk prostate cancer. Although the P3P instrument ameliorates decisional conflict, its use was not associated with more appropriate alignment of treatment with disease risk.",2020,"Although the P3P instrument ameliorates decisional conflict, its use was not associated with more appropriate alignment of treatment with disease risk.","['men with prostate cancer', 'men with low-risk cancer', 'patients with low-risk prostate cancer', '295 men in the cohort: 113 (38%) had low-risk disease, 119 (40%) had favorable intermediate-risk disease, and 63 (21%) had unfavorable intermediate-risk disease']",[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],[],,0.0417948,"Although the P3P instrument ameliorates decisional conflict, its use was not associated with more appropriate alignment of treatment with disease risk.","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Filson', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Niya', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pozzar', 'Affiliation': 'Phyllis F. Cantor Center for Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Halpenny', 'Affiliation': 'Phyllis F. Cantor Center for Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Berry', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, Washington.'}]",Cancer,['10.1002/cncr.33241']
1823,33119156,Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease.,"BACKGROUND


Crohn's disease (CD) is a predisposing factor for bone loss and muscle dysfunction, which could lead to osteoporotic fractures and physical disability, respectively.
AIM


To assess the effect of 6 months of combined impact and resistance training on bone mineral density (BMD) and muscle function in adults with CD.
METHODS


In this randomised controlled trial, 47 adults with stable CD were assigned to exercise (n = 23) or control (n = 24) groups and followed up for 6 months. The exercise group received usual care plus a 6-month combined impact and resistance training programme, involving three, 60-minute sessions per week and a gradual tapering of supervision to self-management. The control group received usual care alone. The primary outcomes were BMD (via dual energy X-ray absorptiometry) and muscle function (measures of upper and lower limb strength and endurance) at 6 months.
RESULTS


At 6 months, BMD values were superior in the exercise group with statistical significance at lumbar spine (adjusted mean difference 0.036 g/cm 2 , 95% CI 0.024-0.048; P < 0.001), but not at femoral neck (0.018 g/cm 2 , 0.001-0.035; P = 0.059) or greater trochanter (0.013 g/cm 2 , -0.019 to 0.045; P = 0.415) after correcting for multiple outcomes. The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005). Three exercise-related adverse events were recorded: two instances of light-headedness and one of nausea.
CONCLUSIONS


The intervention improved BMD and muscle function in adults with CD and appears as a suitable model of exercise for reducing future risk of osteoporotic fractures and disability.
TRIAL REGISTRATION


ISRCTN11470370.",2020,"The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005).","[""adults with stable Crohn's disease"", 'adults with CD', ""Crohn's disease (CD"", '47 adults with stable CD']","['usual care plus a 6-month combined impact and resistance training programme', 'usual care alone', 'resistance training']","['femoral neck', 'BMD values', 'BMD (via dual energy X-ray absorptiometry) and muscle function (measures of upper and lower limb strength and endurance', 'bone mineral density (BMD) and muscle function', 'BMD and muscle function', 'lower fatigue severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",47.0,0.0780562,"The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005).","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R Ally', 'Initials': 'RA', 'LastName': 'Speight', 'Affiliation': 'Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Thompson', 'Affiliation': 'Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Garry A', 'Initials': 'GA', 'LastName': 'Tew', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16002']
1824,33113007,Addition of dexamethasone to manage acute phase responses following initial zoledronic acid infusion.,"Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia, is the most common adverse reaction to initial zoledronic acid infusion. Dexamethasone plus acetaminophen is effective in significantly reducing the incidence and severity of APR.
INTRODUCTION


Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia, is due to immunomodulatory actions and is the most common adverse reaction to zoledronic acid (ZOL). The aims of our study were to compare the differences between acetaminophen and dexamethasone plus acetaminophen on the incidence and severity of APRs and to clarify the clinical factors related to APR with initial ZOL infusion.
METHODS


Patients with osteoporosis receiving their first ZOL infusion (N = 96) were assigned into two groups and given either acetaminophen (58 patients, control group) or acetaminophen plus dexamethasone (38 patients, study group). APRs were assessed through telephone interviews 2 weeks later post-infusion. Clinical, demographic, and serologic data were recorded.
RESULTS


There was a significant increase in the incidence and severity of any APR in the control group than the study group (67% vs. 34%, p = 0.003; 0.69 ± 0.50 vs. 0.34 ± 0.48, p = 0.001). Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group. Multivariate analysis demonstrated that previous use of osteoporosis medication and participation in the study group was negatively related to the occurrence of any APR or myalgia. Advanced age was shown to significantly increase myalgia. Study group participants had significantly reduced severity of myalgia. The adherence for redosing ZOL was significantly higher in the study group.
CONCLUSION


Dexamethasone plus acetaminophen is effective in significantly reducing the incidence and severity of APR, especially myalgia, and increasing adherence following initial ZOL infusion.",2020,"Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group.",['Patients with osteoporosis receiving their first ZOL infusion (N = 96'],"['acetaminophen', 'zoledronic acid (ZOL', 'Dexamethasone plus acetaminophen', 'dexamethasone', 'zoledronic acid infusion', 'acetaminophen and dexamethasone plus acetaminophen', 'acetaminophen plus dexamethasone']","['Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia', 'incidence and severity of any APR', 'incidence and severity of APR, especially myalgia', 'adherence for redosing ZOL', 'severity of myalgia', 'myalgia', 'occurrence of any APR or myalgia', 'myalgia incidence and score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0001349', 'cui_str': 'Acute phase reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0339458,"Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group.","[{'ForeName': 'F-P', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan. fangping@cgmh.org.tw.'}, {'ForeName': 'T-S', 'Initials': 'TS', 'LastName': 'Fu', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan.'}, {'ForeName': 'Y-C', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan.'}, {'ForeName': 'Y-J', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Research Service Center for Health Information, Chang Gung University, Tao-Yuan, 259, Taiwan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05653-0']
1825,33113053,Application of full-field organ dose modulation on cervical- thoraco-abdominopelvic contrast-enhanced computed tomography.,"BACKGROUND AND OBJECTIVE


To study the radiation dose and image quality on the use of full-field organ dose modulation (ODM) on cervical-thoracic-abdominal-pelvic contrast-enhanced computed tomography (CT) scanning on female chemotherapy patients.
METHODS


Eighty female chemotherapy patients undergoing cervical-thoracic-abdominal-pelvic contrast-enhanced CT were prospectively enrolled and randomly divided into two groups: group A and group B, each with 40 patients. Full-field ODM technique was used on group A and regular scanning patterns were used on group B. We calculated and recorded the signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), subjective scores, mean tube currents of the anterior, left, posterior, and right aspects of the thyroid, breast, and ovary layers of all the images. The CT dose index volume (CTDIvol) and dose-length product (DLP) of each patient were recorded and the effective radiation dose (ED) was calculated. The above data were statistically analyzed.
RESULTS


There were no statistically significant differences in the SNR, CNR, and image quality scores of the thyroid, breast, and ovary layers of groups A and B during the arterial and venous phases (P > 0.05). The tube current on the anterior, left, posterior, and right aspects of the thyroid, breast, and ovary layers during the arterial and venous phases (thyroid: 324.46 ± 53.2 and 327.97 ± 61.34; breast: 243.13 ± 50.04 and 248.32 ± 60.33; ovary: 332.28 ± 71.50 and 339.78 ± 76.69; respectively) of group A were (statistically) significantly lower than those of group B (thyroid: 407.60 ± 96.81 and 402.73 ± 90.15; breast: 313.00 ± 106.68 and 315.20 ± 106.73; ovary: 457.78 ± 106.56 and 459.63 ± 106.27; respectively) (P < 0.05). The respective mean CTDIvol and DLP in group A were 22% and 24% lower than those of group B. The mean EDs of the neck, chest, and abdominal-pelvic region in group A were 19.3%, 21.4%, and 26.4% lower than those of group B, respectively (P < 0.05).
CONCLUSION


The use of ODM can reduce radiation dose of female chemotherapy patients undergoing cervical-thoracic-abdominal-pelvic contrast-enhanced CT, especially radiation-sensitive organs, while maintaining overall image quality.",2020,"There were no statistically significant differences in the SNR, CNR, and image quality scores of the thyroid, breast, and ovary layers of groups A and B during the arterial and venous phases (P > 0.05).","['female chemotherapy patients', 'female chemotherapy patients undergoing cervical-thoracic-abdominal-pelvic contrast-enhanced CT', 'Eighty female chemotherapy patients undergoing cervical-thoracic-abdominal-pelvic contrast-enhanced CT']","['cervical-thoracic-abdominal-pelvic contrast-enhanced computed tomography (CT) scanning', 'full-field organ dose modulation (ODM', 'ODM']","['respective mean CTDIvol and DLP', 'CT dose index volume (CTDIvol) and dose-length product (DLP', 'mean EDs of the neck, chest, and abdominal-pelvic region', 'SNR, CNR, and image quality scores of the thyroid, breast, and ovary layers of groups A and B during the arterial and venous phases', 'signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), subjective scores, mean tube currents of the anterior, left, posterior, and right aspects of the thyroid, breast, and ovary layers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439724', 'cui_str': 'Full field'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",80.0,0.0181356,"There were no statistically significant differences in the SNR, CNR, and image quality scores of the thyroid, breast, and ovary layers of groups A and B during the arterial and venous phases (P > 0.05).","[{'ForeName': 'Yongxia', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, 071000, People's Republic of China. zyx_zyx999@163.com.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Geng', 'Affiliation': ""Department of Radiology, Baoding No.2 hospital, Baoding, 071000, People's Republic of China.""}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, 071000, People's Republic of China.""}, {'ForeName': 'Tianle', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, 071000, People's Republic of China.""}, {'ForeName': 'Yize', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, 071000, People's Republic of China.""}]",Japanese journal of radiology,['10.1007/s11604-020-01056-7']
1826,33113075,Photobiomodulation reduces the impact of radiotherapy on oral health-related quality of life due to mucositis-related symptoms in head and neck cancer patients.,"To assess the effectiveness of photobiomodulation therapy (PBMT) in the oral health-related quality of life (OHRQoL) of patients with head and neck cancer undergoing radiotherapy (RT), using the Oral Health Impact Profile-14 (OHIP-14) and the Patient-Reported Oral Mucositis (OM) Symptoms Scale (PROMS), and to correlate OM degree with the PROMS and OHIP-14 scores. Forty-eight patients undergoing RT for head and neck cancer were randomly assigned into two groups: PBMT group (n = 25)-daily PBMT associated with a preventive oral care program (POCP); and control group (n = 23)-receiving POCP exclusively. OHRQoL was assessed using the PROMS and OHIP-14 questionnaires. OM degrees were classified according to the World Health Organization and the National Cancer Institute scales. Assessments were performed at the 1st, 7th, 14th, 21st, and 30th RT sessions. PBMT was effective in preventing and treating severe OM. Both groups showed increased OHRQoL impacts throughout the RT sessions; however, higher impacts were observed in the control group, mainly at the final stage of treatment (21st and 30th RT sessions). Significant correlations were found between the severity of OM and PROMS scores in the total sample and the control group at all RT periods. PROMS and OM scores were positive correlated at 14th, 21st, and 30th RT sessions in the control group, suggesting that this instrument is useful in classifying OM. PBMT was effective in treating and preventing severe OM and OM-related symptoms, and with consequent positive impacts in OHRQoL in head and neck patients undergoing RT. The PROMS scale was helpful instrument for assessment of the severity of OM. Brazilian Clinical Trials database (ReBEC - RBR-5h4y4n), registered in Aug, 24th 2017.",2020,"Both groups showed increased OHRQoL impacts throughout the RT sessions; however, higher impacts were observed in the control group, mainly at the final stage of treatment (21st and 30th RT sessions).","['Forty-eight patients undergoing RT for head and neck cancer', 'patients with head and neck cancer undergoing', 'head and neck patients undergoing RT', 'head and neck cancer patients']","['radiotherapy (RT', 'photobiomodulation therapy (PBMT', 'PBMT group (n = 25)-daily PBMT associated with a preventive oral care program (POCP); and control group (n = 23)-receiving POCP exclusively. OHRQoL', 'radiotherapy', 'PBMT']","['Oral Mucositis (OM) Symptoms Scale (PROMS', 'OHRQoL impacts', 'oral health-related quality of life (OHRQoL', 'severity of OM and PROMS scores', 'oral health-related quality of life', 'PROMS and OM scores']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",48.0,0.0207855,"Both groups showed increased OHRQoL impacts throughout the RT sessions; however, higher impacts were observed in the control group, mainly at the final stage of treatment (21st and 30th RT sessions).","[{'ForeName': 'Allisson Filipe Lopes', 'Initials': 'AFL', 'LastName': 'Martins', 'Affiliation': 'Laboratório de Patologia Oral, Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, 74605-220, Brazil.'}, {'ForeName': 'Marília Oliveira', 'Initials': 'MO', 'LastName': 'Morais', 'Affiliation': 'Hospital de Câncer Araújo Jorge, R. 239, 206 - Setor Universitário, Goiânia, Goiás, 74175-120, Brazil.'}, {'ForeName': 'Sebastião Silvério', 'Initials': 'SS', 'LastName': 'de Sousa-Neto', 'Affiliation': 'Laboratório de Patologia Oral, Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, 74605-220, Brazil.'}, {'ForeName': 'Ana Paula Gonçalves', 'Initials': 'APG', 'LastName': 'de Jesus', 'Affiliation': 'Laboratório de Patologia Oral, Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, 74605-220, Brazil.'}, {'ForeName': 'Tulio Eduardo', 'Initials': 'TE', 'LastName': 'Nogueira', 'Affiliation': 'Departamento de Prevenção e Reabilitação Oral da Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Marize Campos', 'Initials': 'MC', 'LastName': 'Valadares', 'Affiliation': 'Laboratório de Farmacologia e Toxicologia Celuular, Faculdade de Farmácia, Universidade Federal de Goiás, 5ª Avenida Esquina com Rua 240, s/n, Setor Universitário, Goiânia, Goiás, 74605-170, Brazil.'}, {'ForeName': 'Nilceana Maya Aires', 'Initials': 'NMA', 'LastName': 'Freitas', 'Affiliation': 'Departamento de Radioterapia, Hospital de Câncer Araújo Jorge, R. 239, 206-Setor Universitário, Goiânia, Goiás, 74175-120, Brazil.'}, {'ForeName': 'Aline Carvalho', 'Initials': 'AC', 'LastName': 'Batista', 'Affiliation': 'Laboratório de Patologia Oral, Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, 74605-220, Brazil.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Departamento de Prevenção e Reabilitação Oral da Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Elismauro Francisco', 'Initials': 'EF', 'LastName': 'Mendonça', 'Affiliation': 'Laboratório de Patologia Oral, Faculdade de Odontologia, Universidade Federal de Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n, Setor Universitário, Goiânia, Goiás, 74605-220, Brazil. elismaur@ufg.br.'}]",Lasers in medical science,['10.1007/s10103-020-03167-z']
1827,33113155,Depletion of LAG-3 +  T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781.,"Activated T cells drive a range of immune-mediated inflammatory diseases. Lymphocyte activation gene-3 (LAG-3) is transiently expressed on recently activated CD4 +  and CD8 +  T cells. We describe the engineering and first-in-human clinical study (NCT02195349) of GSK2831781 (an afucosylated humanized IgG1 monoclonal antibody enhanced for with high affinity for Fc receptors and LAG-3 and antibody-dependent cellular cytotoxicity capabilities), which depletes LAG-3 expressing cells. GSK2831781 was tested in a phase I/Ib, double-blind, placebo-controlled clinical study, which randomized 40 healthy participants (Part A) and 27 patients with psoriasis (Part B) to single doses of GSK2831781 (up to 0.15 and 5 mg/kg, respectively) or placebo. Adverse events were generally balanced across groups, with no safety or tolerability concern identified. LAG-3 +  cell depletion in peripheral blood was observed at doses ≥ 0.15 mg/kg and was dose-dependent. In biopsies of psoriasis plaques, a reduction in mean group LAG-3 +  and CD3 +  T-cell counts was observed following treatment. Down-regulation of proinflammatory genes (IL-17A, IL-17F, IFNγ and S100A12) and up-regulation of the epithelial barrier integrity gene, CDHR1, was observed with the 5 mg/kg dose of GSK2831781. Psoriasis disease activity improved up to day 43 at all GSK2831781 doses (0.5, 1.5 and 5 mg/kg) compared with placebo. Depletion of LAG-3-expressing activated T cells is a novel approach, and this first clinical study shows that GSK2831781 is pharmacologically active and provides encouraging early evidence of clinical effects in psoriasis, which warrants further investigation in T-cell-mediated inflammatory diseases.",2020,"Down-regulation of proinflammatory genes (IL-17A, IL-17F, IFNγ and S100A12) and up-regulation of the epithelial barrier integrity gene, CDHR1, was observed with the 5 mg/kg dose of GSK2831781.","['40 healthy participants (Part A) and 27 patients with psoriasis (Part B', 'Psoriasis Disease Activity']","['LAG-3 +  T Cells', 'placebo']","['Lymphocyte activation gene-3 (LAG-3', 'Adverse events', 'Psoriasis disease activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0723915,"Down-regulation of proinflammatory genes (IL-17A, IL-17F, IFNγ and S100A12) and up-regulation of the epithelial barrier integrity gene, CDHR1, was observed with the 5 mg/kg dose of GSK2831781.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ellis', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Daniel Jb', 'Initials': 'DJ', 'LastName': 'Marks', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Naren', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Barrett', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hopkins', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Rainard', 'Initials': 'R', 'LastName': 'Fuhr', 'Affiliation': 'Parexel International, Berlin, Germany.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Parexel International, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Coenen', 'Affiliation': 'Study Center Bonn (SZB), Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Liefaard', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Leavens', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Nevin', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Hughes', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Fortunato', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Anselm', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Delves', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Charles', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Feeney', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Webb', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Tim S', 'Initials': 'TS', 'LastName': 'Schmidt', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Caroline Os', 'Initials': 'CO', 'LastName': 'Savage', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Wisniacki', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Tarzi', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2091']
1828,33113161,Effect of hyoscine-N-butylbromide on labor duration among nullipara in a southwestern Nigerian teaching hospital: A randomized controlled trial.,"OBJECTIVE


To assess the effectiveness of hyoscine-N-butylbromide on the duration of the first stage of labor among nulliparous women.
METHODS


A randomized double-blind placebo-controlled study among 126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018. Based on the inclusion criteria, women were recruited and randomized to the study or control group, and given intravenous hyoscine-N-butylbromide 20 mg (1 mL) or sterile water (1 mL), respectively, during the active phase. Labor progress and outcomes were compared between the groups.
RESULTS


The mean ± SD duration of active phase of first stage of labor was significantly shorter in the hyoscine-N-butylbromide group (324.9 ± 134.6 minutes) than in the control group (392.7 ± 119.6 minutes) (P=0.004). The rate of cervical dilatation was 1.4 ± 0.8 cm/hour in the hyoscine-N-butylbromide group and 1.0 ± 0.5 cm/hour in the control group (P=0.004). There were no significant differences in fetal heart rate, maternal vital signs, or Apgar scores between the two groups.
CONCLUSION


Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.",2020,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"['nulliparous women', '126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018', 'labor duration among nullipara in a southwestern Nigerian teaching hospital']","['hyoscine-N-butylbromide 20\xa0mg (1\xa0mL) or sterile water', 'placebo', 'hyoscine-N-butylbromide', 'Hyoscine-N-butylbromide']","['fetal heart rate, maternal vital signs, or Apgar scores', 'mean\xa0±\xa0SD duration of active phase of first stage of labor', 'rate of cervical dilatation']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}]","[{'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]",126.0,0.242392,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"[{'ForeName': 'Adeniyi K', 'Initials': 'AK', 'LastName': 'Akiseku', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University, Ago Iwoye, Ogun State, Nigeria.'}, {'ForeName': 'Olusoji E', 'Initials': 'OE', 'LastName': 'Jagun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adebayo A', 'Initials': 'AA', 'LastName': 'Akadri', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Imaralu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'Adetola O', 'Initials': 'AO', 'LastName': 'Olatunji', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adewale O', 'Initials': 'AO', 'LastName': 'Sule-Odu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13444']
1829,33113196,Efficacy of Multi-Layered Soft Silicone: A Randomized Clinical Trial.,,2020,,[],['Multi-Layered Soft Silicone'],[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]",[],,0.169638,,"[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Mendonça Moraes', 'Affiliation': ''}, {'ForeName': 'Rhea S A', 'Initials': 'RSA', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'Thais D', 'Initials': 'TD', 'LastName': 'Eberhardt', 'Affiliation': ''}, {'ForeName': 'Lidiana B T D', 'Initials': 'LBTD', 'LastName': 'Silveira', 'Affiliation': ''}, {'ForeName': 'Paulo J P', 'Initials': 'PJP', 'LastName': 'Alves', 'Affiliation': ''}, {'ForeName': 'Suzinara', 'Initials': 'S', 'LastName': 'Beatriz Soares de Lima', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13200']
1830,32668114,Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.,"BACKGROUND


Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.
METHODS


We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.
RESULTS


Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).
CONCLUSIONS


Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).",2020,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","['critically ill patients with severe acute kidney injury', 'critically ill patients with acute kidney injury', 'Acute Kidney Injury', 'critically ill patients, many of whom receive renal-replacement therapy', '3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group']","['standard strategy (in which renal-replacement therapy', 'Renal-Replacement Therapy', 'accelerated strategy of renal-replacement therapy']","['Adverse events', 'death', 'death from any cause at 90 days', 'lower risk of death', 'renal-replacement therapy']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",3019.0,0.2899,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Gallagher', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoste', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Thomé', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weir', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000741']
1831,33109516,Experiences of patients and physiotherapists with blended internet-based vestibular rehabilitation: a qualitative interview study.,"BACKGROUND


Internet-based vestibular rehabilitation (VR) with physiotherapy support, known as blended VR, was effective in reducing vestibular symptoms in a recent randomised controlled trial. Blended VR is a complex intervention comprised of physiotherapeutic visits, the vertigo training website, and VR exercises. Because of these interacting components, it is important to understand how blended VR works, for whom it works best, and how it should ideally be delivered.
AIM


To investigate the experiences of both patients and physiotherapists with blended internet-based VR.
DESIGN & SETTING


A qualitative interview study was performed with patients who received blended internet-based VR with physiotherapy support, and physiotherapists who provided this support.
METHOD


Semi-structured interviews were conducted with 14 patients and eight physiotherapists after the 6-month follow-up of the randomised trial. All interviews were audio-recorded, transcribed, and thematically analysed.
RESULTS


According to both patients and physiotherapists, the physiotherapist visits were useful in providing personal attention, helping patients safely execute exercises, and improving patients' adherence to therapy. Some patients said they did not need physiotherapist support and, according to physiotherapists, both the necessity and the optimal way to deliver guidance differed greatly between patients. The Vertigo Training website and exercises provided patients with a sense of control over their symptoms. Patients reported that the VR exercises were easy to perform and most patients continued to use them long after the trial ended.
CONCLUSION


In blended VR, physiotherapeutic visits appear to offer benefits above the vertigo training website and VR exercises alone. Physiotherapy support may best be used when individually tailored.",2020,"According to both patients and physiotherapists, the physiotherapist visits were useful in providing personal attention, helping patients safely execute exercises, and improving patients' adherence to therapy.","['patients and physiotherapists with', 'Semi-structured interviews were conducted with 14 patients and eight physiotherapists after the 6-month follow-up of the randomised trial']","['blended internet-based VR', 'VR exercises', 'blended internet-based VR with physiotherapy support, and physiotherapists who provided this support', 'blended internet-based vestibular rehabilitation', 'Internet-based vestibular rehabilitation (VR']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]",[],14.0,0.0177625,"According to both patients and physiotherapists, the physiotherapist visits were useful in providing personal attention, helping patients safely execute exercises, and improving patients' adherence to therapy.","[{'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands v.vanvugt@vumc.nl.'}, {'ForeName': 'Anja JThCM', 'Initials': 'AJ', 'LastName': 'de Kruif', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}]",BJGP open,['10.3399/bjgpopen20X101092']
1832,33109532,Nurse home visiting and prenatal substance use in a socioeconomically disadvantaged population in British Columbia: analysis of prenatal secondary outcomes in an ongoing randomized controlled trial.,"BACKGROUND


Nurse-Family Partnership (NFP) involves public health nurses providing frequent home visits from early pregnancy until children reach age 2 years, focusing on first-time parents experiencing socioeconomic disadvantage. Our aim was to evaluate NFP's effectiveness in improving child and maternal health.
METHODS


We conducted an analysis of prenatal secondary outcomes in an ongoing randomized controlled trial in British Columbia; the data used in this analysis were collected from January 2014 to May 2017. Participants were pregnant girls and women aged 14-24 years who were preparing to parent for the first time and experiencing socioeconomic disadvantage. They were randomly allocated 1:1 to the intervention (NFP plus existing services) or control group (existing services). Prespecified prenatal secondary outcome indicators were changes in use of nicotine cigarettes and alcohol use by 34-36-weeks' gestation. We also report on prespecified exploratory cannabis and street drug use measures. We used mixed-effect models for longitudinal and clustered data to estimate intervention effects. Analyses were by intention to treat.
RESULTS


The median gestational age at baseline for the 739 participants (368 participants in the intervention group, 371 in the comparison group) was 20 weeks, 6 days. By 34-36 weeks' gestation, NFP significantly reduced cigarette counts (over the past 2 d) (difference in changes [DIC] of count -1.6, 95% confidence interval [CI] -6.4 to -1.3) in those who smoked. NFP also significantly reduced rates of prenatal cannabis use (DIC -6.4, 95% CI -17.0 to -1.7), but not rates of street drug or ""any"" substance use. While we observed decreased rates of cigarette and alcohol use in both groups (DIC of proportions -2.8, 95% CI -15.3 to 0.6; DIC -0.5, 95% CI -8.7 to 1.8, respectively), these changes were not statistically significant.
INTERPRETATION


We found no evidence that NFP was effective in reducing rates of prenatal cigarette and alcohol use; however, it led to reduced prenatal cannabis use, and in smokers it led to modest reductions in cigarette use. NFP may therefore hold promise for reducing some types of prenatal substance use in disadvantaged populations.  Trial registration:  ClinicalTrials.gov, no. NCT01672060.",2020,"NFP also significantly reduced rates of prenatal cannabis use (DIC -6.4, 95% CI -17.0 to -1.7), but not rates of street drug or ""any"" substance use.","['The median gestational age at baseline for the 739 participants (368 participants in the intervention group, 371 in the comparison group) was 20 weeks, 6 days', 'socioeconomically disadvantaged population in British Columbia', 'Participants were pregnant girls and women aged 14-24 years who were preparing to parent for the first time and experiencing socioeconomic disadvantage']","['NFP', 'intervention (NFP plus existing services) or control group (existing services', 'Nurse-Family Partnership (NFP']","['cigarette counts', 'rates of cigarette and alcohol use', ""changes in use of nicotine cigarettes and alcohol use by 34-36-weeks' gestation"", 'rates of prenatal cannabis use', ""NFP's effectiveness""]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.195352,"NFP also significantly reduced rates of prenatal cannabis use (DIC -6.4, 95% CI -17.0 to -1.7), but not rates of street drug or ""any"" substance use.","[{'ForeName': 'Nicole L A', 'Initials': 'NLA', 'LastName': 'Catherine', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyle', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'McCandless', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Lever', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Sheehan', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Jack', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Lil', 'Initials': 'L', 'LastName': 'Tonmyr', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Lenora', 'Initials': 'L', 'LastName': 'Marcellus', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Varcoe', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Ange', 'Initials': 'A', 'LastName': 'Cullen', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Hjertaas', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Riebe', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Rikert', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Ashvini', 'Initials': 'A', 'LastName': 'Sunthoram', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Barr', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'MacMillan', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Waddell', 'Affiliation': ""Children's Health Policy Centre, Faculty of Health Sciences (Catherine, Zheng, Lever, Sheehan, Cullen, Hjertaas, Riebe, Rikert, Sunthoram, Waddell), Simon Fraser University, Vancouver, BC; Offord Centre for Child Studies, Faculty of Health Sciences (Boyle, Gonzalez, Jack, MacMillan), McMaster University, Hamilton, Ont.; Faculty of Health Sciences (McCandless, Xie), Simon Fraser University, Burnaby, BC; Arthritis Research Canada (Xie), Richmond, BC; School of Nursing, Faculty of Health Sciences (Jack) and Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences (Gafni), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Tonmyr), Ottawa, Ont.; School of Nursing (Marcellus), University of Victoria, Victoria, BC; School of Nursing (Varcoe); Department of Pediatrics (Barr), Faculty of Medicine, University of British Columbia, Vancouver, BC charlotte_waddell@sfu.ca.""}]",CMAJ open,['10.9778/cmajo.20200063']
1833,33109638,"Translating new evidence into clinical practice: a quasi-experimental controlled before-after study evaluating the effect of a novel outreach mentoring approach on knowledge, attitudes and confidence of health workers providing HIV and infant feeding counselling in South Africa.","OBJECTIVES


We report the effectiveness of a mentoring approach to improve health workers' (HWs') knowledge, attitudes and confidence with counselling on HIV and infant feeding.
DESIGN


Quasi-experimental controlled before-after study.
SETTING


Randomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa.
PARTICIPANTS


All HWs providing infant feeding counselling in selected facilities were invited.
INTERVENTIONS


Three 1-2 hours, on-site workshops over 3-6 weeks.
PRIMARY OUTCOME MEASURES


Knowledge (22 binary questions), attitude (21 questions-5-point Likert Scale) and confidence (19 questions-3-point Likert Scale). Individual item responses were added within each of the attitude and confidence domains. The respective sums were taken to be the domain composite index and used as a dependent variable to evaluate intervention effect. Linear regression models were used to estimate the mean score difference between intervention and comparison groups postintervention, adjusting for the mean score difference between them at baseline. Analyses were adjusted for participant baseline characteristics and clustering at health facility level.
RESULTS


In intervention and comparison sites, respectively: 289 and 131 baseline and 253 and 114 follow-up interviews were conducted (August-December 2017). At baseline there was no difference in mean number of correctly answered knowledge questions; this differed significantly at follow-up (15.2 in comparison; 17.2 in intervention sites (p<0.001)). At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively). Controlling for confounders, interactions between time and intervention group and preintervention values, the attitude score was 5.1 points significantly higher in intervention versus comparison groups.
CONCLUSION


A participatory, low-intensity on-site mentoring approach to disseminating updated infant feeding guidelines improved HWs' knowledge, attitudes and confidence more than standard dissemination via a circular. Further research is required to evaluate the effectiveness, feasibility and sustainability of this approach at scale.",2020,"At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively).","['health workers providing HIV and infant feeding counselling in South Africa', 'Randomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa', 'All HWs providing infant feeding counselling in selected facilities were invited']","['novel outreach mentoring approach', 'mentoring approach']","[""health workers' (HWs') knowledge, attitudes and confidence"", 'Knowledge (22 binary questions), attitude (21 questions-5-point Likert Scale) and confidence (19 questions-3-point Likert Scale', 'mean number of correctly answered knowledge questions', 'attitude score', 'mean attitude and confidence scores towards breast feeding']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.0339395,"At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively).","[{'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Goga', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa Ameena.Goga@mrc.ac.za.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Manda', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Tshifhiwa', 'Initials': 'T', 'LastName': 'Nkwenika', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Haskins', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'John', 'Affiliation': 'School of Education, University of KwaZulu Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'Ingunn M S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Feucht', 'Affiliation': 'Department of Paediatrics, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dhansay', 'Affiliation': 'Division of Human Nutrition and Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rollins', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Kroon', 'Affiliation': 'Department of Neonatology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Shuaib', 'Initials': 'S', 'LastName': 'Kauchali', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Horwood', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}]",BMJ open,['10.1136/bmjopen-2019-034770']
1834,33109641,Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial.,"INTRODUCTION


Intra-articular (IA) injection of hyaluronic acid (HA) and corticosteroid (CS) is a common treatment for osteoarthritis (OA) of the knee. As a drug treatment for patients with depression, duloxetine has been shown in many studies to effectively relieve the pain of OA and improve function of the knee joint. However, evidence regarding the efficacy of IA injection of HA+CS combined with duloxetine for pain management in patients with OA of the knee is lacking. The aim of this study was to test the hypothesis that IA injection of HA+CS combined with duloxetine could achieve pain management superior to that of IA injection of HA+CS alone in patients experiencing knee OA pain.
METHODS


This study will adopt a prospective, randomised, open-label blind endpoint study design. In total, 150 patients with OA of the knee will be enrolled in the study. The participants will be randomly allocated to receive either a single IA injection of HA+CS combined with duloxetine or a single IA injection of HA+CS alone, and both groups will complete a 24-week follow-up to assess pain and functional improvements. The primary outcome measure is the change in the weekly mean of the 24 hours average pain scores from baseline to the end of 24 weeks in patients with OA of the knee, and the secondary outcomes include the response to treatment, changes from baseline in the brief pain inventory, improvement in the Western Ontario and McMaster Universities Osteoarthritis index scores, patient global impression of improvement scale, Hospital Anxiety and Depression Scale and adverse events during the 24-week follow-up. The data will be analysed by the intention-to-treat principle.
ETHICS APPROVAL AND DISSEMINATION


This study was approved by the institutional ethics committee of the Beijing Tiantan Hospital (approval number: KY 2019-086-02). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT04117893; Pre-results.",2020,"The primary outcome measure is the change in the weekly mean of the 24 hours average pain scores from baseline to the end of 24 weeks in patients with OA of the knee, and the secondary outcomes include the response to treatment, changes from baseline in the brief pain inventory, improvement in the Western Ontario and McMaster Universities Osteoarthritis index scores, patient global impression of improvement scale, Hospital Anxiety and Depression Scale and adverse events during the 24-week follow-up.","['osteoarthritis (OA) of the knee', 'Beijing Tiantan Hospital (approval number: KY 2019-086-02', 'knee osteoarthritis', '150 patients with OA of the knee will be enrolled in the study', 'patients with depression', 'patients with OA of the knee is lacking', 'patients experiencing knee OA pain']","['HA+CS combined with duloxetine or a single IA injection of HA+CS alone', 'Duloxetine combined with intra-articular injection versus intra-articular injection alone', 'HA+CS alone', 'HA+CS', 'duloxetine', 'hyaluronic acid (HA) and corticosteroid (CS']","['brief pain inventory, improvement in the Western Ontario and McMaster Universities Osteoarthritis index scores, patient global impression of improvement scale, Hospital Anxiety and Depression Scale and adverse events', 'pain and functional improvements', 'change in the weekly mean of the 24\u2009hours average pain scores', 'pain relief']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.159685,"The primary outcome measure is the change in the weekly mean of the 24 hours average pain scores from baseline to the end of 24 weeks in patients with OA of the knee, and the secondary outcomes include the response to treatment, changes from baseline in the brief pain inventory, improvement in the Western Ontario and McMaster Universities Osteoarthritis index scores, patient global impression of improvement scale, Hospital Anxiety and Depression Scale and adverse events during the 24-week follow-up.","[{'ForeName': 'Duo Yi', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhi Gang', 'Initials': 'ZG', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China luofangwt@yahoo.com 1022zzg@sina.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China luofangwt@yahoo.com 1022zzg@sina.com.'}]",BMJ open,['10.1136/bmjopen-2019-036447']
1835,33109926,The effect of temporal information on placebo analgesia and nocebo hyperalgesia.,"OBJECTIVE


Expectations are known to be key determinants of placebo and nocebo phenomena. In previous studies, verbal suggestions to induce such expectations have mainly focused on the direction and magnitude of the effect while little is known about the influence of temporal information.
METHODS


Using an experimental placebo and nocebo design, we investigated whether information about the expected onset of a treatment effect modulates the start and time-course of analgesic and hyperalgesic responses. Healthy volunteers (N=166) in three placebo and three nocebo groups were informed that the application of an (inert) cream would reduce (placebo groups) or amplify pain (nocebo groups) after 5, 15 or 30 minutes. Two control groups were also included (Natural History and No Expectations). Participants' pain intensity rating of electrical stimuli administered before and 10, 20 and 35 minutes after cream application were obtained.
RESULTS


Mixed-method analysis of variance showed a signifcanat interaction between group and time F(12,262)=18.172, p<0.001, pη2=0.454, suggesting that pain variations differed across time points and between groups. Post hoc comparisons revealed that placebo and nocebo groups began to show a significantly larger change in perceived pain intensity than a no-expectancy control group at the expected time-point (p<0.05) but not earlier (p>0.05). Once triggered, the analgesic effect remained constant over the course of the experiment whereas the hyperalgesic effect increased over time.
CONCLUSIONS


Our results indicate that temporal suggestions can shape expectancy-related treatment effects which - if used systematically - could open up new ways to optimise treatment outcome.",2020,Post hoc comparisons revealed that placebo and nocebo groups began to show a significantly larger change in perceived pain intensity than a no-expectancy control group at the expected time-point (p<0.05) but not earlier (p>0.05).,['Healthy volunteers (N=166) in three'],"['application of an (inert) cream would reduce (placebo groups) or amplify pain (nocebo groups', 'placebo']","['pain variations', 'pain intensity rating of electrical stimuli', 'hyperalgesic effect increased over time', 'pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.267732,Post hoc comparisons revealed that placebo and nocebo groups began to show a significantly larger change in perceived pain intensity than a no-expectancy control group at the expected time-point (p<0.05) but not earlier (p>0.05).,"[{'ForeName': 'Eleonora Maria', 'Initials': 'EM', 'LastName': 'Camerone', 'Affiliation': 'Department of Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Piedimonte', 'Affiliation': 'Department of Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Science (DINOGMI), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wiech', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Denisa Adina', 'Initials': 'DA', 'LastName': 'Zamfira', 'Affiliation': 'Department of Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Carlino', 'Affiliation': 'Department of Neuroscience, University of Turin Medical School, Turin, Italy.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000882']
1836,33109935,Embedding a Linkage to Pre-Exposure Prophylaxis (PrEP) Care Intervention in Social Network Strategy and Partner Notification Services: Results from a Pilot Randomized Controlled Trial.,"BACKGROUND


Increased pre-exposure prophylaxis (PrEP) uptake among Black men who have sex with men and Black transgender women (BMSM/TW) is needed to end the HIV epidemic. Embedding a brief intervention in network services that engage individuals in HIV transmission networks for HIV/STI testing may be an important strategy to accelerate PrEP uptake.
SETTING


Partner Services PrEP (PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.
METHODS


BMSM/TW (N=146) aged 18-40 were recruited from network services (partners services and social network strategy services). Intervention participants developed an individualized linkage plan based on the Information-Motivation-Behavioral Skills model and received mini-booster sessions. Control participants received treatment as usual. Socio-demographic, behavioral, and clinical factors were examined at baseline, three- and 12-months post-intervention. Intent-to-treat analyses examined linkage to PrEP care within three months post-intervention (primary outcome). Secondary outcomes were PrEP initiation, time to linkage to PrEP care, and time to PrEP initiation.
RESULTS


Compared to control participants, a significantly greater proportion of the intervention participants were linked to PrEP care within three months (24% vs. 11%; p=0.04) and initiated PrEP (24% vs. 11%, p=0.05). Among those linked to PrEP care within the study period, intervention participants were linked significantly sooner than control participants (median [interquartile range] days, 26.5 [6.0, 141.8] vs. 191.5 [21.5, 297.0]; p=0.05).
CONCLUSION


Study results support the preliminary efficacy of PS-PrEP to improve linkage to PrEP care and PrEP initiation among BMSM/TW.(word count/word limit = 248/250).",2020,"(PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.
","['Social Network Strategy and Partner Notification Services', 'BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017', 'Black men who have sex with men and Black transgender women (BMSM/TW', 'BMSM/TW (N=146) aged 18-40 were recruited from network services (partners services and social network strategy services', 'Partner Services PrEP']","['individualized linkage plan based on the Information-Motivation-Behavioral Skills model and received mini-booster sessions', 'Increased pre-exposure prophylaxis (PrEP) uptake', 'PS-PrEP', 'Embedding a Linkage to Pre-Exposure Prophylaxis (PrEP) Care Intervention']","['Socio-demographic, behavioral, and clinical factors', 'PrEP initiation, time to linkage to PrEP care, and time to PrEP initiation']","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0820963,"(PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Teixeira da Silva', 'Affiliation': 'Department of Combined Internal Medicine and Pediatrics, University of Chicago, Chicago, IL.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Bouris', 'Affiliation': 'School of Social Service Administration, University of Chicago, Chicago, IL.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Blocker', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pyra', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Rusie', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Pagkas-Bather', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hotton', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Jessica P', 'Initials': 'JP', 'LastName': 'Ridgway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'McNulty', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002548']
1837,33110039,TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial.,"OBJECTIVE


The aim of the study was to evaluate the clinically meaningful effect of oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules on hot flushes severity (vasomotor symptoms [VMS] severity scale) using the patient-reported Clinical Global Impression (CGI).
METHODS


REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial that evaluated TX-001HR in postmenopausal women (40-65 y) with a uterus. Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized in a VMS substudy to daily E2/P4 (1/100, 0.5/100, 0.5/50, or 0.25/50 mg/mg), or placebo. Patients rated VMS severity from 1 (mild) to 3 (severe) and symptom improvements with the CGI. CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
RESULTS


In the VMS substudy (n = 726), determined CID and minimal CID severity thresholds were reductions of 0.525 and 0.350 points at week 4, respectively, and 0.775 and 0.225 points at week 12. Significantly more women taking the two highest E2/P4 doses (1/100 and 0.5/100) versus placebo met CID severity thresholds at weeks 4 (40% and 44% vs 17%; P < 0.05) and 12 (56% and 48% vs 29%; P < 0.05).
CONCLUSION


REPLENISH trial data demonstrated that E2/P4 1/100 and 0.5/100 provided clinically meaningful improvements in hot flushes severity in postmenopausal women. In conjunction with previously demonstrated clinically meaningful VMS frequency improvements, these data support oral E2/P4 1/100 and 0.5/100 for postmenopausal women with a uterus seeking treatment for moderate to severe VMS.",2020,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","['Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk', 'postmenopausal women with a uterus seeking treatment for moderate to severe VMS', 'postmenopausal women (40-65 y) with a uterus', 'postmenopausal women']","['oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules', 'placebo', 'TX-001HR']","['CID and minimal CID severity thresholds', 'hot flushes severity (vasomotor symptoms [VMS] severity scale', 'CID severity thresholds', 'VMS severity']","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.432405,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","[{'ForeName': 'Ginger D', 'Initials': 'GD', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Revicki', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001602']
1838,33110042,The severity of vasomotor symptoms and number of menopausal symptoms in postmenopausal women and select clinical health outcomes in the Women's Health Initiative Calcium and Vitamin D randomized clinical trial.,"OBJECTIVE


This study evaluated whether vasomotor symptom (VMS) severity and number of moderate/severe menopausal symptoms (nMS) were associated with health outcomes, and whether calcium and vitamin D (CaD) modified the risks.
METHODS


The Women's Health Initiative CaD study was a double blind, randomized, placebo-controlled trial, which tested 400 IU of 25-hydroxyvitamin-D and 1,000 mg of calcium per day in women aged 50 to 79 years. This study included 20,050 women (median follow-up of 7 y). The outcomes included hip fracture, colorectal cancer, invasive breast cancer, all-cause mortality, coronary heart disease, stroke, cardiovascular death, and total cardiovascular disease (CVD). MS included: hot flashes, night sweats, dizziness, heart racing, tremors, feeling restless, feeling tired, difficulty concentrating, forgetfulness, mood swings, vaginal dryness, breast tenderness, migraine, and waking up several times at night. Associations between VMS severity and nMS with outcomes were tested.
RESULTS


No association between VMS severity and any outcome were found. In contrast, nMS was associated with higher stroke (hazard ratio [HR] 1.40 95% confidence interval [CI] 1.04-1.89 for ≥ 2 MS vs none; HR 1.20 95% CI 0.89-1.63 for 1 MS vs none, P trend = 0.03) and total CVD (HR 1.35, 95% CI, 1.18-1.54 for ≥ 2 MS vs none; HR 0.99, 95% CI, 0.87-1.14 for 1 MS vs none P trend < 0.001). CaD did not modify any association.
CONCLUSION


Severity of VMS was not associated with any outcome. Having ≥2 moderate or severe MS was associated with an increased risk for CVD. The number of moderate/severe MS may be a marker for higher CVD risk. : Video Summary:http://links.lww.com/MENO/A669.",2020,"In contrast, nMS was associated with higher stroke (hazard ratio [HR] 1.40 95% confidence interval [CI] 1.04-1.89 for ≥ 2 MS vs none; HR 1.20 95% CI 0.89-1.63 for 1 MS vs none, P trend = 0.03) and total CVD (HR 1.35, 95% CI, 1.18-1.54 for ≥ 2 MS vs none; HR 0.99, 95% CI, 0.87-1.14 for 1 MS vs none P trend < 0.001).","['women aged 50 to 79 years', '20,050 women (median follow-up of 7 y', 'postmenopausal women', ""The Women's Health Initiative""]","['calcium and vitamin D (CaD', 'placebo', ' Video Summary:http://links.lww.com/MENO/A669', '25-hydroxyvitamin-D and 1,000\u200amg of calcium']","['MS included: hot flashes, night sweats, dizziness, heart racing, tremors, feeling restless, feeling tired, difficulty concentrating, forgetfulness, mood swings, vaginal dryness, breast tenderness, migraine, and waking up several times at night', 'total CVD', 'Severity of VMS', 'vasomotor symptom (VMS) severity and number of moderate/severe menopausal symptoms (nMS', 'vasomotor symptoms and number of menopausal symptoms', 'hip fracture, colorectal cancer, invasive breast cancer, all-cause mortality, coronary heart disease, stroke, cardiovascular death, and total cardiovascular disease (CVD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0849970', 'cui_str': 'Tired'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0542476', 'cui_str': 'Forgetful'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",20050.0,0.504151,"In contrast, nMS was associated with higher stroke (hazard ratio [HR] 1.40 95% confidence interval [CI] 1.04-1.89 for ≥ 2 MS vs none; HR 1.20 95% CI 0.89-1.63 for 1 MS vs none, P trend = 0.03) and total CVD (HR 1.35, 95% CI, 1.18-1.54 for ≥ 2 MS vs none; HR 0.99, 95% CI, 0.87-1.14 for 1 MS vs none P trend < 0.001).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nudy', 'Affiliation': 'Departments of Cardiology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Departments of ObGyn, Reading Hospital/Tower Health, Reading, PA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital/Harvard Medical School, Division of Preventive Medicine, Boston, MA.""}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'Department of Family Medicine and Public Health, School of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Foy', 'Affiliation': 'Departments of Cardiology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Buerger', 'Affiliation': 'Departments of ObGyn, Reading Hospital/Tower Health, Reading, PA.'}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Kelsey', 'Affiliation': 'Department of Cardiology, Duke University, Durham, NC.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Center for Health Research NW, Kaiser Permanente, Portland, Oregon.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Colleges of Medicine and Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, University at Buffalo, SUNY, Buffalo NY.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Robbins', 'Affiliation': 'UC Davis Medical Center, Sacramento, CA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Schnatz', 'Affiliation': 'Departments of ObGyn, Reading Hospital/Tower Health, Reading, PA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001667']
1839,33113311,Inspiratory Muscle Training Based on Anaerobic Threshold on the Functional Capacity of Patients After Coronary Artery Bypass Grafting: Clinical Trial.,"INTRODUCTION


Coronary artery bypass grafting (CABG) is associated with reduced ventilatory muscle strength and consequent worsening of functional capacity (FC). Inspiratory Muscle Training (IMT) can be indicated, but there is still a lack of knowledge about the use of the anaerobic threshold (AT) as a basis for prescription. The objective of this study is to evaluate if IMT based on AT modifies FC and inspiratory muscle strength of patients submitted to CABG.
METHODS


This is a clinical trial. On the first postoperative day, the patients were divided into two groups: the conventional group (IMT-C), which performed IMT based on 40% of maximal inspiratory pressure (MIP), and the IMT-AT group, which performed IMT based on AT. All patients underwent preoperative and postoperative assessment of MIP and performed a six-minute walk test (6MWT).
RESULTS


Forty-two patients were evaluated, 21 in each group. Their mean age was 61.4±10 years and 27 (64%) of them were male. There was a reduction of inspiratory muscle strength with a delta of 23±13 cmH2O in the IMT-C group vs. 11±10 cmH2O in the IMT-AT group (P<0.01) and of the walking distance with a delta of 94±34 meters in the IMT-C group vs. 57±30 meters in the IMT-AT group (P=0.04).
CONCLUSION


IMT based on AT minimized the loss of FC and inspiratory muscle strength of patients submitted to CABG.",2020,"There was a reduction of inspiratory muscle strength with a delta of 23±13 cmH2O in the IMT-C group vs. 11±10 cmH2O in the IMT-AT group (P<0.01) and of the walking distance with a delta of 94±34 meters in the IMT-C group vs. 57±30 meters in the IMT-AT group (P=0.04).
","['Their mean age was 61.4±10 years and 27 (64%) of them were male', 'patients submitted to CABG']","['Coronary artery bypass grafting (CABG', 'IMT', 'conventional group (IMT-C), which performed IMT based on 40% of maximal inspiratory pressure (MIP), and the IMT-AT group, which performed IMT based on AT', 'Inspiratory Muscle Training (IMT', 'Inspiratory Muscle Training']","['FC and inspiratory muscle strength', 'inspiratory muscle strength']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",42.0,0.0212617,"There was a reduction of inspiratory muscle strength with a delta of 23±13 cmH2O in the IMT-C group vs. 11±10 cmH2O in the IMT-AT group (P<0.01) and of the walking distance with a delta of 94±34 meters in the IMT-C group vs. 57±30 meters in the IMT-AT group (P=0.04).
","[{'ForeName': 'André Luiz Lisboa', 'Initials': 'ALL', 'LastName': 'Cordeiro', 'Affiliation': 'Department of Human Medicine and Health, Escola Bahiana de Medicina e Saúde Pública, Unidade Acadêmica Brotas, Salvador, Bahia, Brazil.'}, {'ForeName': 'Hayssa de Cássia', 'Initials': 'HC', 'LastName': 'Mascarenhas', 'Affiliation': 'Department of Human Medicine and Health, Escola Bahiana de Medicina e Saúde Pública, Unidade Acadêmica Brotas, Salvador, Bahia, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Landerson', 'Affiliation': 'Department of Physiotherapy, Faculdade Nobre de Feira de Santana, Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Jaclene da Silva', 'Initials': 'JDS', 'LastName': 'Araújo', 'Affiliation': 'Department of Physiotherapy, Faculdade Nobre de Feira de Santana, Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Daniel Lago', 'Initials': 'DL', 'LastName': 'Borges', 'Affiliation': 'Department of Physiotherapy, Cardiological Intensive Care Unit, Hospital Universitário da Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Thiago Araújo de', 'Initials': 'TA', 'LastName': 'Melo', 'Affiliation': 'Department of Physiotherapy, Universidade Salvador, Salvador, Bahia, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Guimarães', 'Affiliation': 'Department of Cardiovascular Surgery, Instituto Nobre de Cardiologia, Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Petto', 'Affiliation': 'Department of Human Medicine and Health, Escola Bahiana de Medicina e Saúde Pública, Unidade Acadêmica Brotas, Salvador, Bahia, Brazil.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0448']
1840,31659214,The effects of temporal pressure on obstacle negotiation and gaze behaviour in young adults with simulated vision loss.,"Individuals with vision loss adapt their locomotion and gaze behaviour to safely negotiate objects in temporally unconstrained situations. However, everyday activities are often performed under time-pressure. We investigated the effects of blur on anxiety, movement kinematics and gaze behaviour during the negotiation of a floor-based obstacle under three amounts of pressure: 1) no-pressure; 2) tonal-pressure: an intermittent tone was played at a constant frequency; 3) tonal + time pressure: the intermittent tone increased in frequency and participants had to walk 20% faster to reach the end of the lab. Irrespective of the amount of pressure, the blurred vs. normal vision group reported 32% more anxiety, lifted the lead foot 43% higher and 10% slower over the obstacle, and looked 6% longer and 6% more frequently ahead of the obstacle. In the tonal + time pressure vs. no-pressure condition, both groups were more anxious, showed adaptations in movement kinematics related to walking faster, and adopted a 'checking strategy' by shortening their fixation durations at the obstacle. These results show that irrespective of temporal pressure, the blurred vision group remained more cautious as to how the lead foot negotiated the obstacle, in order to reduce the chance of tripping during crossing.",2019,"We investigated the effects of blur on anxiety, movement kinematics and gaze behaviour during the negotiation of a floor-based obstacle under three amounts of pressure: 1) no-pressure; 2) tonal-pressure: an intermittent tone was played at a constant frequency; 3) tonal + time pressure: the intermittent tone increased in frequency and participants had to walk 20% faster to reach the end of the lab.",['young adults with simulated vision loss'],[],"['obstacle negotiation and gaze behaviour', 'anxiety, movement kinematics and gaze behaviour']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",[],"[{'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.0265127,"We investigated the effects of blur on anxiety, movement kinematics and gaze behaviour during the negotiation of a floor-based obstacle under three amounts of pressure: 1) no-pressure; 2) tonal-pressure: an intermittent tone was played at a constant frequency; 3) tonal + time pressure: the intermittent tone increased in frequency and participants had to walk 20% faster to reach the end of the lab.","[{'ForeName': 'Tjerk', 'Initials': 'T', 'LastName': 'Zult', 'Affiliation': 'Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine, and Social Care, Anglia Ruskin University, Cambridge, United Kingdom. tjerk.zult@anglia.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Allsop', 'Affiliation': 'Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine, and Social Care, Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Timmis', 'Affiliation': 'Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine, and Social Care, Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Shahina', 'Initials': 'S', 'LastName': 'Pardhan', 'Affiliation': 'Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine, and Social Care, Anglia Ruskin University, Cambridge, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-51926-y']
1841,31664121,Mode of delivery and pregnancy outcomes in preterm birth: a secondary analysis of the WHO Global and Multi-country Surveys.,"Many studies have been conducted to examine whether Caesarean Section (CS) or vaginal birth (VB) was optimal for better maternal and neonatal outcomes in preterm births. However, findings remain unclear. Therefore, this secondary analysis of World Health Organization Global Survey (GS) and Multi-country Survey (MCS) databases was conducted to investigate outcomes of preterm birth by mode of delivery. Our sample were women with singleton neonates (15,471 of 237 facilities from 21 countries in GS; and 15,053 of 239 facilities from 21 countries in MCS) delivered between 22 and <37 weeks of gestation. We assessed association between mode of delivery and pregnancy outcomes in singleton preterm births by multilevel logistic regression adjusted for hierarchical data. The prevalences of women with preterm birth delivered by CS were 31.0% and 36.7% in GS and MCS, respectively. Compared with VB, CS was associated with significantly increased odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission but significantly decreased odds of fresh stillbirth, and perinatal death. However, since the information on justification for mode of delivery (MOD) were not available, our results of the potential benefits and harms of CS should be carefully considered when deciding MOD in preterm births.",2019,"Compared with VB, CS was associated with significantly increased odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission but significantly decreased odds of fresh stillbirth, and perinatal death.","['preterm birth', 'singleton preterm births', 'Our sample were women with singleton neonates (15,471 of 237 facilities from 21 countries in GS; and 15,053 of 239 facilities from 21 countries in MCS) delivered between 22 and <37 weeks of gestation']",['Caesarean Section (CS) or vaginal birth (VB'],"['odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission', 'prevalences of women with preterm birth delivered by CS', 'fresh stillbirth, and perinatal death']","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0405334', 'cui_str': 'Fresh stillbirth'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}]",,0.108543,"Compared with VB, CS was associated with significantly increased odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission but significantly decreased odds of fresh stillbirth, and perinatal death.","[{'ForeName': 'Bao Yen Luong', 'Initials': 'BYL', 'LastName': 'Thanh', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Pisake', 'Initials': 'P', 'LastName': 'Lumbiganon', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District, Khon Kaen, 40002, Thailand. pisake@kku.ac.th.'}, {'ForeName': 'Porjai', 'Initials': 'P', 'LastName': 'Pattanittum', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Malinee', 'Initials': 'M', 'LastName': 'Laopaiboon', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': 'UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research World Health Organization, Avenue Appia 20, Geneva, Switzerland.'}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': 'UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research World Health Organization, Avenue Appia 20, Geneva, Switzerland.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pileggi-Castro', 'Affiliation': 'Independent Consultant, Geneva, Switzerland.'}, {'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Mori', 'Affiliation': 'Department of Health Policy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 157-8535, Japan.'}, {'ForeName': 'Kapila', 'Initials': 'K', 'LastName': 'Jayaratne', 'Affiliation': 'Maternal & Child Morbidity & Mortality Surveillance, Family Health Bureau - Ministry of Health, 231 De Saram Place, Colombo 10, Colombo, Sri Lanka.'}, {'ForeName': 'Zahida', 'Initials': 'Z', 'LastName': 'Qureshi', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Joã', 'Initials': 'J', 'LastName': 'Souza', 'Affiliation': 'UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research World Health Organization, Avenue Appia 20, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-52015-w']
1842,31664143,Study of Periodontal Health in Almada-Seixal (SoPHiAS): a cross-sectional study in the Lisbon Metropolitan Area.,"This study aimed to describe the prevalence and extent of periodontal diseases among adults in the southern region of the Lisbon Metropolitan Area. This population-based cross-sectional study included 1,064 randomized participants (aged 18 to 95 years, 617 females/447 males). Sociodemographic, behaviours and medical information were recorded. Periodontal conditions were assessed with a full-mouth circumferential periodontal examination. It was used the American Association of Periodontology/European Federation of Periodontology 2017 case definitions. A logistic regression analysis was applied to ascertain hypothetical risk factors towards periodontitis. The prevalence of periodontitis was 59.9%, with 24.0% and 22.2% of the participants exhibiting severe and moderate periodontitis, respectively. The risk of periodontitis significantly increased with age (OR = 1.05, 95% CI: 1.04-1.06), for active and former smokers (OR = 3.76 and OR = 2.11, respectively), with lower education levels (OR = 2.08, OR = 1.86, for middle and elementary education, respectively) and with diabetes mellitus (OR = 1.53). This study confirms a high burden of periodontitis in the target (Portuguese) sub-population. The findings provide a comprehensive understanding that will empower appropriate national public oral health programmes and population-based preventive actions.",2019,"The risk of periodontitis significantly increased with age (OR = 1.05, 95% CI: 1.04-1.06), for active and former smokers (OR = 3.76 and OR = 2.11, respectively), with lower education levels (OR = 2.08, OR = 1.86, for middle and elementary education, respectively) and with diabetes mellitus (OR = 1.53).","['Periodontal Health in Almada-Seixal', 'Lisbon Metropolitan Area', 'adults in the southern region of the Lisbon Metropolitan Area', '1,064 randomized participants (aged 18 to 95 years, 617 females/447 males']",[],"['risk of periodontitis', 'prevalence of periodontitis', 'Sociodemographic, behaviours and medical information']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",1064.0,0.0784825,"The risk of periodontitis significantly increased with age (OR = 1.05, 95% CI: 1.04-1.06), for active and former smokers (OR = 3.76 and OR = 2.11, respectively), with lower education levels (OR = 2.08, OR = 1.86, for middle and elementary education, respectively) and with diabetes mellitus (OR = 1.53).","[{'ForeName': 'João', 'Initials': 'J', 'LastName': 'Botelho', 'Affiliation': 'Periodontology Department, Egas Moniz Dental Clinic (EMDC), Egas Moniz, CRL, Monte de Caparica, Portugal. jbotelho@egasmoniz.edu.pt.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Machado', 'Affiliation': 'Periodontology Department, Egas Moniz Dental Clinic (EMDC), Egas Moniz, CRL, Monte de Caparica, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Proença', 'Affiliation': 'Quantitative Methods for Health Research Unit (MQIS), CiiEM, Egas Moniz, CRL, Monte de Caparica, Portugal.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alves', 'Affiliation': 'Periodontology Department, Egas Moniz Dental Clinic (EMDC), Egas Moniz, CRL, Monte de Caparica, Portugal.'}, {'ForeName': 'Maria Alzira', 'Initials': 'MA', 'LastName': 'Cavacas', 'Affiliation': 'Clinical Research Unit (CRU), Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Egas Moniz, CRL, Monte de Caparica, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Amaro', 'Affiliation': 'Health Centers grouping (HCG) Almada-Seixal, Regional Health Administration of Lisbon and Tagus Valley (RHALTV), Lisbon, Portugal.'}, {'ForeName': 'José João', 'Initials': 'JJ', 'LastName': 'Mendes', 'Affiliation': 'Clinical Research Unit (CRU), Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Egas Moniz, CRL, Monte de Caparica, Portugal.'}]",Scientific reports,['10.1038/s41598-019-52116-6']
1843,31673048,The 14q32 maternally imprinted locus is a major source of longitudinally stable circulating microRNAs as measured by small RNA sequencing.,"Understanding the normal temporal variation of serum molecules is a critical factor for identifying useful candidate biomarkers for the diagnosis and prognosis of chronic disease. Using small RNA sequencing in a longitudinal study of 66 women with no history of cancer, we determined the distribution and dynamics (via intraclass correlation coefficients, ICCs) of the miRNA profile over 3 time points sampled across 2-5 years in the course of the screening trial, UKCTOCS. We were able to define a subset of longitudinally stable miRNAs (ICC >0.75) that were individually discriminating of women who had no cancer over the study period. These miRNAs were dominated by those originating from the C14MC cluster that is subject to maternal imprinting. This assessment was not significantly affected by common confounders such as age, BMI or time to centrifugation nor alternative methods to data normalisation. Our analysis provides important benchmark data supporting the development of miRNA biomarkers for the impact of life-course exposure as well as diagnosis and prognostication of chronic disease.",2019,We were able to define a subset of longitudinally stable miRNAs (ICC >0.75) that were individually discriminating of women who had no cancer over the study period.,"['66 women with no history of cancer', 'women who had no cancer over the study period']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],66.0,0.0394956,We were able to define a subset of longitudinally stable miRNAs (ICC >0.75) that were individually discriminating of women who had no cancer over the study period.,"[{'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Valbuena', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London, W12 0NN, United Kingdom.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Apostolidou', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, Gower Street, London, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, Gower Street, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': 'Abcodia Ltd, PO Box 268, Royston, SG8 1EL, Hertfordshire, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Alderton', 'Affiliation': 'Abcodia Ltd, PO Box 268, Royston, SG8 1EL, Hertfordshire, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Cancer Research UK, Angel Building, 407 St John Street, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, Gower Street, London, UK.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, Gower Street, London, UK.'}, {'ForeName': 'Hector C', 'Initials': 'HC', 'LastName': 'Keun', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London, W12 0NN, United Kingdom. h.keun@imperial.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-51948-6']
1844,31693299,Impact of fractional excretion of sodium on a single morning void urine collection as an estimate of 24-hour urine sodium.,"The standard for assessing dietary sodium intake is to measure 24-hour urine sodium. On average, 93% of daily sodium intake is excreted over 24-hours. Expense and difficulties in obtaining complete 24-hour collections have led to the measurement of sodium concentration in spot and single-void urine samples, using predictive equations to estimate 24-hour urine sodium. Although multiple predictive equations have been developed, in addition to having an average bias, all the equations overestimate 24-hour sodium at lower levels of 24-hour sodium and underestimate 24-hour urine sodium at higher levels of 24-hour sodium. One of the least biased estimating equations is the INTERSALT equation, which incorporates a spot urine creatinine concentration. The authors hypothesized that differential fractional excretion of sodium (FeNa)(derived from a morning void collection) relative to creatinine would impact on the accuracy of the INTERSALT equation in estimating 24-hour urine sodium. In a prospective study of 139 adults aged 65 years and over, three sequential morning void and 24-hour urine samples were examined. There was a significant correlation between increasing FENa and the difference between estimated and measured 24-hours urine sodium (r = 0.358, P < .01). In the lowest quartile of FENa, the INTERSALT equation overestimated 24-hour urine sodium, but underestimated 24-hour urine sodium with greater magnitude in each of the subsequent quartiles of FENa. Differential excretion of sodium relative to creatinine, potentially impacted by renal blood flow and hydration, among other factors, affected the accuracy of the INTERSALT equation. Additional research may refine the INTERSALT and other predictive equations to increase their accuracy.",2019,"There was a significant correlation between increasing FENa and the difference between estimated and measured 24-hours urine sodium (r = 0.358, P < .01).","['139 adults aged 65\xa0years and over, three sequential morning void and 24-hour urine samples were examined']",[],"['24-hours urine sodium', '24-hour urine sodium']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0456209', 'cui_str': '24 hour urine sample'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",[],"[{'cui': 'C1278233', 'cui_str': '24 hour urine sodium output measurement'}]",139.0,0.0292776,"There was a significant correlation between increasing FENa and the difference between estimated and measured 24-hours urine sodium (r = 0.358, P < .01).","[{'ForeName': 'Caryl A', 'Initials': 'CA', 'LastName': 'Nowson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, Geelong, Waurn Ponds Campus, Geelong, Vic., Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, Geelong, Waurn Ponds Campus, Geelong, Vic., Australia.'}, {'ForeName': 'Norm R C', 'Initials': 'NRC', 'LastName': 'Campbell', 'Affiliation': ""Departments of Medicine, Community Health Sciences, and Physiology and Pharmacology, O'Brien Institute of Public Health, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, Geelong, Waurn Ponds Campus, Geelong, Vic., Australia.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Centre for Environmental and Preventive Medicine, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, Geelong, Waurn Ponds Campus, Geelong, Vic., Australia.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13725']
1845,33113452,Using Machine Learning to Predict Suicide Attempts in Military Personnel.,"Identifying predictors of suicide attempts is critical in intervention and prevention efforts, yet finding predictors has proven difficult due to the low base rate and underpowered statistical approaches. The objective of the current study was to use machine learning to examine predictors of suicidal behaviors among high-risk suicidal Soldiers who received outpatient mental health services in a randomized controlled trial of Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) compared to treatment as usual (TAU). Self-report measures of clinical and demographic variables, administered prior to the start of outpatient treatment to 152 participants with recent suicidal thoughts and/or behaviors were analyzed using machine learning software to identify the best combination of variables for predicting suicide attempts during or after treatment. Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period. This combination has higher sensitivity than many models that have previously been used to predict suicidal behavior. Overall, this study provides a combination of variables that can be assessed clinical to help identify high-risk suicidal individuals.",2020,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","['high-risk suicidal Soldiers who received outpatient mental health services', '152 participants with recent suicidal thoughts and/or behaviors', 'Military Personnel']","['Machine Learning', 'machine learning', 'Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT']",['suicidal behaviors'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",152.0,0.0395007,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rozek', 'Affiliation': 'UCF RESTORES and Department of Psychology, University of Central Florida. Electronic address: david.rozek@ucf.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Andres', 'Affiliation': 'Boston College, Boston, MA.'}, {'ForeName': 'Noelle B', 'Initials': 'NB', 'LastName': 'Smith', 'Affiliation': 'VA Northeast Program Evaluation Center, West Haven, CT, USA; Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Feea R', 'Initials': 'FR', 'LastName': 'Leifker', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Arne', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Jennings', 'Affiliation': 'Varen Technologies.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Dartnell', 'Affiliation': 'MondoBrain.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'The Ohio State University Wexner Medical Center.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'University of Memphis, Memphis, TN, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113515']
1846,33113486,Integrating yoga with psychological group-treatment for mixed depression and anxiety in primary healthcare: An explorative pilot study.,"BACKGROUND AND PURPOSE


Yoga has shown promise as a treatment for depression and anxiety. The present pilot study investigated the feasibility of an eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga for depression and anxiety in primary healthcare.
MATERIALS AND METHODS


Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an integrative group-treatment (N = 14) or treatment as usual (TAU, N = 17). Outcome measures were analysed pre- and posttreatment. Correlations in the intervention group were investigated between treatment outcomes and amount of yoga practice between sessions.
RESULTS


Large within-group effect sizes on all outcome measures were found at posttreatment. Symptom reduction did not differ between groups (p = 0.155). Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
CONCLUSION


Integrating yoga with a psychological group-treatment is a somewhat feasible approach to treatment for depression and anxiety in primary healthcare.",2020,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","['Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an', 'primary healthcare']","['integrative group-treatment (N\xa0=\xa014) or treatment as usual (TAU', 'eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga', 'Integrating yoga with psychological group-treatment']","['alexithymia', 'Symptom reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0320634,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","[{'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: gustav@psykologiochutveckling.se.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzén', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: lisa.franzen@regionvarmland.se.'}, {'ForeName': 'Markus B T', 'Initials': 'MBT', 'LastName': 'Nyström', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Markus.nystrom@umu.se.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Paul.davis@umu.se.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101250']
1847,33113526,High-Dose Erythropoietin in Extremely Low Gestational Age Neonates Does Not Alter Risk of Retinopathy of Prematurity.,"INTRODUCTION


The Preterm Erythropoietin (Epo) Neuroprotection (PENUT) Trial sought to determine the safety and efficacy of early high-dose Epo as a potential neuroprotective treatment. We hypothesized that Epo would not increase the incidence or severity of retinopathy of prematurity (ROP).
METHODS


A total of 941 infants born between 24-0/7 and 27-6/7 weeks' gestation were randomized to 1,000 U/kg Epo or placebo intravenously for 6 doses, followed by subcutaneous or sham injections of 400 U/kg Epo 3 times a week through 32 weeks post-menstrual age. In this secondary analysis of PENUT trial data, survivors were evaluated for ROP. A modified intention-to-treat approach was used to compare treatment groups. In addition, risk factors for ROP were evaluated using regression methods that account for multiples and allow for adjustment for treatment and gestational age at birth.
RESULTS


Of 845 subjects who underwent ROP examination, 503 were diagnosed with ROP with similar incidence and severity between treatment groups. Gestational age at birth, birth weight, prenatal magnesium sulfate, maternal antibiotic exposure, and presence of heart murmur at 2 weeks predicted the development of any ROP, while being on high-frequency oscillator or high-frequency jet ventilation (HFOV/HFJV) at 2 weeks predicted severe ROP.
CONCLUSION


Early high-dose Epo followed by maintenance dosing through 32 weeks does not increase the risk of any or severe ROP in extremely low gestational age neonates. Gestational age, birth weight, maternal treatment with magnesium sulfate, antibiotic use during pregnancy, and presence of a heart murmur at 2 weeks were associated with increased risk of any ROP. Treatment with HFOV/HFJV was associated with an increased risk of severe ROP.",2020,Early high-dose Epo followed by maintenance dosing through 32 weeks does not increase the risk of any or severe ROP in extremely low gestational age neonates.,"['Extremely Low Gestational Age Neonates', ""941 infants born between 24-0/7 and 27-6/7 weeks' gestation"", '845 subjects who underwent ROP examination, 503 were diagnosed with ROP']","['HFOV', 'HFJV', 'High-Dose Erythropoietin', 'Epo or placebo', 'magnesium sulfate']","['risk of any or severe ROP', 'safety and efficacy', 'risk of severe ROP', 'Gestational age at birth, birth weight, prenatal magnesium sulfate, maternal antibiotic exposure, and presence of heart murmur', 'Risk of Retinopathy of Prematurity', 'incidence or severity of retinopathy of prematurity (ROP', 'risk of any ROP']","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018808', 'cui_str': 'Heart murmur'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",941.0,0.136173,Early high-dose Epo followed by maintenance dosing through 32 weeks does not increase the risk of any or severe ROP in extremely low gestational age neonates.,"[{'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA, mayock@uw.edu.'}, {'ForeName': 'Zimeng', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Division of Biomedical Statistics, Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Division of Biomedical Statistics, Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Division of Biomedical Statistics, Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neonatology,['10.1159/000511262']
1848,33111239,Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients.,"BACKGROUND


The prevalence of substance use disorders is higher among medical inpatients than in the general population, placing inpatient providers in a prime position to detect these patients and intervene.
OBJECTIVE


To assess provider detection rates of substance use disorders among medical inpatients and to identify patient characteristics associated with detection.
DESIGN


Data drawn from a cluster randomized controlled trial that tested the effectiveness of three distinct implementation strategies for providers to screen patients for substance use disorders and deliver a brief intervention (Clinical Trials.gov : NCT01825057).
PARTICIPANTS


A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study.
MAIN MEASURES


Data sources included patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records. Provider detection was determined by diagnoses documented in medical records.
KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%). Detection of alcohol use disorder was more likely among male compared to female patients (OR (95% CI) = 4.0 (1.9, 4.8)). When compared to White patients, alcohol (OR (95% CI) = 0.4 (0.2, 0.6)) and opioid (OR (95% CI) = 0.2 (0.1, 0.7)) use disorders were less likely to be detected among Black patients, while alcohol (OR (95% CI) = 0.3 (0.0, 2.0)) and cocaine (OR (95% CI) = 0.3 (0.1, 0.9)) use disorders were less likely to be detected among Hispanic patients. Providers were more likely to detect nicotine, alcohol, opioid, and other drug use disorders among patients with higher addiction severity (OR (95% CI) = 1.20 (1.08-1.34), 1.62 (1.48, 1.78), 1.46 (1.07, 1.98), 1.38 (1.00, 1.90), respectively).
CONCLUSIONS


Findings indicate patient characteristics, including gender, race, and addiction severity impact rates of provider detection. Instituting formal screening for all substances may increase provider detection and inform treatment decisions.",2020,"KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%).","['Providers of General Medical Inpatients', 'A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study']",[],"['patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records', 'Provider detection rates', 'Provider detection']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",1076.0,0.05571,"KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%).","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA. kristin.serowik@yale.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06319-7']
1849,33111247,Exercise Enhances the Effect of Bariatric Surgery in Markers of Cardiac Autonomic Function.,"BACKGROUND


Bariatric surgery improves cardiovascular health, which might be partly ascribed to beneficial alterations in the autonomic nervous system. However, it is currently unknown whether benefits from surgery on cardiac autonomic regulation in post-bariatric patients can be further improved by adjuvant therapies, namely exercise. We investigated the effects of a 6-month exercise training program on cardiac autonomic responses in women undergoing bariatric surgery.
METHODS


Sixty-two women eligible for bariatric surgery were randomly allocated to either standard of care (control) or an exercise training intervention. At baseline (PRE) and 3 (POST3) and 9 (POST9) months after surgery, we assessed chronotropic response to exercise (CR%; i.e., percentage change in heart rate from rest to peak exercise) and heart rate recovery (HRR30s, HRR60s, and HRR120s; i.e., decay of heart rate at 30, 60, and 120 s post exercise) after a maximal exercise test.
RESULTS


Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group.
CONCLUSIONS


Our findings demonstrate that exercise training enhanced the benefits of bariatric surgery on cardiac autonomic regulation. These results highlight the relevance of exercise training as a treatment for post-bariatric patients, ensuring optimal cardiovascular outcomes.",2020,"RESULTS


Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group.
","['women undergoing bariatric surgery', 'Sixty-two women eligible for bariatric surgery']","['exercise training program', 'Bariatric Surgery', 'exercise training', 'standard of care (control) or an exercise training intervention']","['cardiac autonomic regulation', 'HRR30s', 'CR', 'chronotropic response to exercise (CR%; i.e., percentage change in heart rate from rest to peak exercise) and heart rate recovery (HRR30s, HRR60s, and HRR120s; i.e., decay of heart rate', 'HRR60s', 'cardiovascular health', 'HRR120s', 'cardiac autonomic responses']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",62.0,0.0582273,"RESULTS


Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group.
","[{'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Igor Hisashi', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos Alberto Abujabra', 'Initials': 'CAA', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosa Maria Rodrigues', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Department of Digestive Surgery, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurélio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Department of Digestive Surgery, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Diego Augusto Nunes', 'Initials': 'DAN', 'LastName': 'Rezende', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil. hars@usp.br.'}]",Obesity surgery,['10.1007/s11695-020-05053-7']
1850,33111337,Pharmacodynamics and pharmacokinetics of DWP14012 (fexuprazan) in healthy subjects with different ethnicities.,"BACKGROUND


DWP14012 (fexuprazan), a novel potassium-competitive acid blocker, is under development for the treatment of acid-related disorders.
AIMS


To compare the pharmacodynamics (PDs), pharmacokinetics (PKs) and safety of DWP14012 among healthy subjects of Korean, Caucasian and Japanese descent.
METHODS


A randomised, double-blind, placebo-controlled, single- and multiple-dose study was conducted. Ten subjects in each dose group (40, 60 or 80 mg for Koreans; 40 or 80 mg for Caucasians; 20, 40 or 80 mg for Japanese) were randomly assigned to DWP14012 or a placebo. Twenty-four-hour intragastric pH measurements and serial blood samples were collected for PK/PD evaluation. The PK/PD parameters were compared between each ethnicity.
RESULTS


The extent of gastric acid suppression was similar among the ethnicities; the mean percentages of time that the intragastric pH was above 4 after multiple doses of 40 mg in the Korean, Caucasian and Japanese subjects were 64.3%, 62.8% and 70.3%, respectively, and the corresponding values for the 80 mg dose were 94.8%, 90.6% and 90.6% respectively. The changes in serum gastrin were not clinically significant between all three ethnicities. The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses. Gastric acid suppression by DWP14012 showed a clear exposure-response relationship in the three ethnicities.
CONCLUSIONS


Gastric acid suppression by DWP14012 was similar among the Korean, Caucasian and Japanese subjects in this study, and the PK, PK-PD relationships and safety were also similar among the three ethnicities. DWP14012 could be used without consideration of ethnicity.",2020,The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses.,"['healthy subjects with different ethnicities', 'healthy subjects of Korean, Caucasian and Japanese descent', 'Ten subjects in each dose group (40, 60 or 80\xa0mg for Koreans; 40 or 80\xa0mg for Caucasians; 20, 40 or 80\xa0mg for Japanese']","['placebo', 'DWP14012 (fexuprazan']","['serum gastrin', 'pharmacodynamics (PDs), pharmacokinetics (PKs) and safety of DWP14012', 'systemic exposure of DWP14012', 'Gastric acid suppression', 'gastric acid suppression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.0767119,The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses.,"[{'ForeName': 'Jun Gi', 'Initials': 'JG', 'LastName': 'Hwang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Inseung', 'Initials': 'I', 'LastName': 'Jeon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Ae', 'Initials': 'SA', 'LastName': 'Park', 'Affiliation': 'Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Areum', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16131']
1851,33111359,"A preliminary investigation of the effects of short-duration, vigorous exercise following sleep restriction, fragmentation and extension on appetite and mood in inactive, middle-aged men.","This preliminary study aimed to investigate the effect of exercise on appetite and mood following multiple days of sleep disruption (restriction [RES], fragmentation [FRAG]) or sleep extension (EXT), compared to normal sleep (CONT) in inactive, middle-aged men. Nine men completed four randomised trials initiated by 3 nights (day 1-3) of CONT (6.5-8 hr), RES (4 hr), FRAG (6.5-8 hr, interrupted at 2-hr intervals) or EXT (10 hr). On day 4 between 08:30 and 11:00 hours, perceived appetite, food cravings, appetite-related hormones (acylated ghrelin, leptin, peptide tyrosine-tyrosine [PYY] total  ), glucose, mood states and wellness (stress, fatigue, soreness, and mood) were assessed before (post-sleep manipulation [SM]) and after (post-exercise [EX]) a 20-min vigorous cycling bout (rating of perceived exertion: 15). There was no effect of sleep manipulation or exercise on perceived appetite (p = .34-.62). Some aspects of food craving were altered after RES and EXT, with vigorous exercise attenuating the desire for sweet foods in RES (p = .12). PYY total  was lower after RES compared to EXT and FRAG (p = .03), but was unaltered by exercise (p = .03). Ghrelin was higher for RES and EXT compared to CONT and FRAG after exercise (p = .001-.03). Total wellness was reduced and total mood disturbance (TMD) was higher after RES and FRAG compared to CONT and EXT (p ≤ .05). However, vigorous exercise countered these changes, with wellness and TMD remaining significantly impaired for FRAG compared to EXT only at this time (p = .02-.03). Vigorous exercise mitigates some aspects of food cravings and counters the impaired mood states that exist after multiple days of restricted and fragmented sleep.",2020,Ghrelin was higher for RES and EXT compared to CONT and FRAG after exercise (p = .001-.03).,"['in inactive, middle-aged men', 'normal sleep (CONT) in inactive, middle-aged men']","['FRAG', 'short-duration, vigorous exercise', 'sleep disruption (restriction [RES], fragmentation [FRAG]) or sleep extension (EXT', 'Vigorous exercise', 'EXT', 'exercise', 'CONT']","['sleep manipulation or exercise on perceived appetite', 'wellness and TMD remaining significantly impaired for FRAG', 'appetite and mood', 'perceived appetite, food cravings, appetite-related hormones (acylated ghrelin, leptin, peptide tyrosine-tyrosine [PYY] total  ), glucose, mood states and wellness (stress, fatigue, soreness, and mood', 'food craving', 'total mood disturbance (TMD', 'Total wellness']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}]",,0.0415391,Ghrelin was higher for RES and EXT compared to CONT and FRAG after exercise (p = .001-.03).,"[{'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Larsen', 'Affiliation': 'School of Medicine, Faculty of Health and Behavioural Sciences, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Marino', 'Affiliation': 'School of Exercise Science, Sport and Health, Charles Sturt University, Bathurst, NSW, Australia.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Guelfi', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Duffield', 'Affiliation': 'School of Sport, Exercise and Rehabilitation, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Skein', 'Affiliation': 'School of Exercise Science, Sport and Health, Charles Sturt University, Bathurst, NSW, Australia.'}]",Journal of sleep research,['10.1111/jsr.13215']
1852,33111380,Examination of nursing students' anxiety levels related to clinical practice with respect to peer support.,"PURPOSE


To investigate the relationship between stress and anxiety levels of nursing students at during their first clinical practice.
DESIGN AND METHODS


Designed as a quasi-experimental study with a study group (n = 13) and a control group (n = 13) among nursing students at a university.
FINDINGS


Students who practiced in the clinic for the first time experienced stress and anxiety, and their stress levels increased with high levels of state anxiety. The stress and anxiety decreased using peer support of the study group there was no change in the control group.
IMPLICATIONS FOR NURSING PRACTICE


It is recommended that nursing students who enter clinical practice for the first time use peer support to reduce stress and anxiety in clinical practice.",2020,"The stress and anxiety decreased using peer support of the study group there was no change in the control group.
","['Designed as a quasi-experimental study with a study group (n\u2009=\u200913) and a control group (n\u2009=\u200913) among nursing students at a university', 'nursing students at during their first clinical practice']",[],['stress and anxiety'],"[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0161734,"The stress and anxiety decreased using peer support of the study group there was no change in the control group.
","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Tambağ', 'Affiliation': 'Nursing Department, Hatay School of Health Psychiatric, Hatay Mustafa Kemal University, Antakya, Hatay, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12664']
1853,33111424,Near-infrared spectroscopy measures of sternocleidomastoid blood flow during exercise and hyperpnoea.,"NEW FINDINGS


What is the central question of this study? How does sternocleidomastoid blood flow change in response to increasing ventilation and whole-body exercise intensity? What is the main finding and its importance? We found that sternocleidomastoid blood flow increased with increasing ventilation. We also found that for a given ventilation, sternocleidomastoid blood flow was lower during whole-body exercise compared to resting hyperpnoea. Our findings suggest that locomotor muscle work exerts an effect on respiratory muscle blood flow that can be observed in the sternocleidomastoid.
ABSTRACT


Respiratory muscle work influences the distribution of blood flow during exercise. Most studies have focused on blood flow to the locomotor musculature rather than the respiratory muscles, owing to the complex anatomical arrangement of respiratory muscles. The purpose of this study was to examine how accessory respiratory (i.e., sternocleidomastoid, and muscles in the intercostal space) muscle blood flow changes in response to locomotor muscle work. Seven men performed five-minute bouts of constant load cycling exercise trials at 30, 60, and 90% of peak work rate in randomized order, followed by five-minute bouts of voluntary hyperpnoea (VH) matching the ventilation achieved during each exercise (EX) trial. Blood-flow index (BFI) of the vastus lateralis (VL), sternocleidomastoid (SCM), and 7 th  intercostal space (IC) were estimated using near-infrared spectroscopy and indocyanine green and expressed relative to resting levels. BFI SCM  was greater during VH compared to EX (p = 0.002) and increased with increasing exercise intensity (p = 0.036). BFI SCM  reached 493±219 % rest and 262±203 % rest during VH and EX at 90% peak work rate, respectively. BFI IC  increased to 241±177% rest and 207±123% rest at 30% peak work rate during VH and EX, respectively. No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both p>0.05). Moreover, there was no observed difference in BFI IC  between conditions (p>0.05). BFI SCM  was lower for a given minute ventilation during EX compared to VH, suggesting that accessory respiratory muscle blood flow is influenced by whole-body exercise. This article is protected by copyright. All rights reserved.",2020,No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both p>0.05).,[],['voluntary hyperpnoea (VH) matching the ventilation achieved during each exercise (EX'],"['exercise intensity', 'BFI IC', 'Blood-flow index (BFI) of the vastus lateralis (VL), sternocleidomastoid (SCM), and 7 th  intercostal space (IC', 'sternocleidomastoid blood flow', 'respiratory muscle blood flow', 'BFI SCM']",[],"[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0230136', 'cui_str': 'Structure of intercostal space'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",7.0,0.0231482,No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both p>0.05).,"[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Carli M', 'Initials': 'CM', 'LastName': 'Peters', 'Affiliation': 'School of Kinesiology, Faculty of Education, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Leahy', 'Affiliation': 'School of Kinesiology, Faculty of Education, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'School of Kinesiology, Faculty of Education, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Jasinovic', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, Faculty of Education, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': ""Centre for Heart Lung Innovation, The University of British Columbia and St. Paul's Hospital, Vancouver, British Columbia, Canada.""}]",Experimental physiology,['10.1113/EP089045']
1854,33111541,Translating CDSMP to the Workplace: Results of the Live Healthy Work Healthy Program.,"PURPOSE


Report the results of a randomized, controlled trial of Live Healthy, Work Healthy (LHWH), a worksite translation of the Chronic Disease Self-Management Program (CDSMP).
DESIGN


14 worksites were randomly assigned to LHWH, standard CDSMP (usual care) or no-intervention (control) group.
SETTING


The diverse set of work organizations centered around a rural community in SE US.
SUBJECTS


411 participants completed baseline data with 359 being included in the final analyses.
INTERVENTION


LHWH had been adapted to fit the unique characteristics of work organizations. This translated program consists of 15 sessions over 8 weeks and was facilitated by trained lay leaders.
MEASURES


The primary outcomes including health risk, patient-provider communication, quality of life, medical adherence and work performance were collected pretest, posttest (6 mos.) and follow-up (12 mos.).
ANALYSIS


Analyses were conducted using latent change score models in a structural equation modeling framework.
RESULTS


79% of participants reported at least one chronic condition with an average of 2.7 chronic conditions reported. Results indicated that LHWH program demonstrated positive changes in a most outcomes including significant exercise (uΔ = 0.89, p < .01), chronic disease self-efficacy (uΔ = 0.63, p < .05), fatigue (uΔ = -1.45, p < .05), stress (uΔ = -0.98, p < .01) and mentally unhealthy days (uΔ = -3.47, p < .001).
CONCLUSIONS


The translation of LHWH is an effective, low cost, embeddable program that has the potential to improve the health and work life of employees.",2020,"Results indicated that LHWH program demonstrated positive changes in a most outcomes including significant exercise (uΔ = 0.89, p < .01), chronic disease self-efficacy (uΔ = 0.63, p < .05), fatigue (uΔ = -1.45, p < .05), stress (uΔ = -0.98, p < .01) and mentally unhealthy days (uΔ = -3.47, p < .001).
","['14 worksites', 'Live Healthy, Work Healthy (LHWH), a worksite translation of the Chronic Disease Self-Management Program (CDSMP', '411 participants completed baseline data with 359 being included in the final analyses']","['LHWH', 'LHWH, standard CDSMP (usual care) or no-intervention (control) group']","['health risk, patient-provider communication, quality of life, medical adherence and work performance', 'fatigue', 'stress', 'chronic disease self-efficacy']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",411.0,0.0228939,"Results indicated that LHWH program demonstrated positive changes in a most outcomes including significant exercise (uΔ = 0.89, p < .01), chronic disease self-efficacy (uΔ = 0.63, p < .05), fatigue (uΔ = -1.45, p < .05), stress (uΔ = -0.98, p < .01) and mentally unhealthy days (uΔ = -3.47, p < .001).
","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Wilson', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'DeJoy', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Vandenberg', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Padilla', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Haynes', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Zuercher', 'Affiliation': 'Workplace Health Group, 189617College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Phaedra', 'Initials': 'P', 'LastName': 'Corso', 'Affiliation': 'Office of the Vice President for Research, 15617Kennesaw State University, Kennesaw, GA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lorig', 'Affiliation': 'Self-Management Resource Center, Palo Alto, CA, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, and Department of Environmental and Occupational Health, School of Public Health, 2655Texas A&M University, College Station, TX, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120968031']
1855,33111605,The Effects of Case-Based Teaching in Nursing Skill Education: Cases Do Matter.,"Nursing skill education plays a very important part for the nursing education. It's necessary to analyze the role of the case-based teaching (CBT) in nursing skill education, to provide insights into the nursing education. The sophomore nursing students who received nursing skill teaching from September 2019 to January 2020 were selected. The students either underwent traditional teaching (control group) or CBT (CBT group) intervention. The objective structure clinical examination (OSCE), autonomous learning ability, questionnaire for effects evaluation of CBT, and student's satisfaction level on CBT were analyzed. A total of 146 participants were included. There were no significant differences in the gender, age and the final exam score as freshman between 2 groups (all  P  > .05). The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05). The most students favored the use of CBT, and most students were satisfied with CBT. CBT is beneficial to improve the nursing skill and comprehensive ability of students, and it's conducive to increase the interest of students, which merits application in nursing education.",2020,The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05).,"['A total of 146 participants were included', 'sophomore nursing students who received nursing skill teaching from September 2019 to January 2020 were selected']","['CBT', 'traditional teaching (control group) or CBT (CBT group) intervention', 'Case-Based Teaching']",['OSCE scores and autonomous learning ability'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",146.0,0.0119905,The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05).,"[{'ForeName': 'Lanfang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Health Vocational College, Nanchang, China.'}, {'ForeName': 'Mengqian', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Jiangxi Health Vocational College, Nanchang, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Jinggangshan University, Ji'an, Jiangxi, China.""}]","Inquiry : a journal of medical care organization, provision and financing",['10.1177/0046958020964421']
1856,33111647,Ethnoracial differences in treatment-seeking veterans with substance use disorders and co-occurring PTSD: Presenting characteristics and response to integrated exposure-based treatment.,"OBJECTIVE


Substance use disorders (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur. While previous research has examined ethnoracial differences among individuals with either SUD or PTSD, little research to date has focused on individuals with co-occurring SUD/PTSD. The current study addresses this gap in the literature.
METHOD


Participants were 79 military veterans (91% male; 38% African American [AA] and 62% White) with current SUD/PTSD who were randomized to receive Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) or Relapse Prevention (RP). Primary outcomes included substance use and self-reported and clinician-rated PTSD symptoms.
RESULTS


At baseline, AA participants were significantly older, reported greater substance and alcohol use, and tended to report higher PTSD severity than White participants. AA participants evidenced greater decreases in substance and alcohol use during treatment, but greater increases in substance and alcohol use during follow-up as compared to White participants. All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment. Additionally, White participants receiving RP reported greater increases in DDD during follow-up compared to AA participants.
CONCLUSION


Overall, integrated treatment for co-occurring SUD/PTSD was effective for both AA and White participants; however, some important differences emerged by ethnoracial group. Findings suggest that greater attention to race and ethnicity is warranted to better understand the needs of diverse patients with SUD/PTSD and to optimize treatment outcomes.",2020,"All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment.","['individuals with either SUD or PTSD', 'treatment-seeking veterans with substance use disorders and co-occurring PTSD', 'Participants were 79 military veterans (91% male; 38% African American [AA] and 62% White) with current SUD/PTSD']",['PTSD and Substance Use Disorders using Prolonged Exposure (COPE) or Relapse Prevention (RP'],"['DDD', 'substance and alcohol use', 'substance use and self-reported and clinician-rated PTSD symptoms', 'alcohol consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",91.0,0.0208936,"All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment.","[{'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Jarnecke', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Therese K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of ethnicity in substance abuse,['10.1080/15332640.2020.1836699']
1857,33111656,Real-Time Psychophysiological and Writing Correlates of Expressive Writing.,"Concealing memories and emotions associated with a traumatic event seems to have negative effects on health. Re-enacting those events through writing is an opportunity to disclose such memories and emotions, and especially for emotion regulation. To study this, 57 university students were randomly assigned to one of two groups. They either completed an expressive writing or a neutral writing task. Real-time writing and psychophysiological data were recorded throughout the experiment to examine writing dynamics associated with emotion regulation and its psychophysiological correlates (electrodermal activity and electrocardiography measures). The results showed that the expressive group (EG) paused for longer than the control group (CG) denoting a positive and medium effect size    (   η   p   2   =   .10   )      . Furthermore, during and after writing, the EG showed a higher low frequency/high frequency ratio than the CG, evidencing a positive and large effect size    (   η   p   2   =   .22   )      . These real-time findings are interpreted as signs of emotion regulation happening during writing.",2020,The results showed that the expressive group (EG) paused for longer than the control group (CG) denoting a positive and medium effect size    (   η   p   2   =   .10   )      .,['57 university students'],['expressive writing or a neutral writing task'],['Real-Time Psychophysiological and Writing Correlates of Expressive Writing'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]",,0.0152726,The results showed that the expressive group (EG) paused for longer than the control group (CG) denoting a positive and medium effect size    (   η   p   2   =   .10   )      .,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Jacques', 'Affiliation': 'Faculty of Psychology and Education Sciences, University of Porto, Portugal.'}, {'ForeName': 'Rui A', 'Initials': 'RA', 'LastName': 'Alves', 'Affiliation': 'Faculty of Psychology and Education Sciences, University of Porto, Portugal.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Fadaei', 'Affiliation': 'Faculty of Psychology and Education Sciences, University of Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Barbosa', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Portugal.'}]",Experimental psychology,['10.1027/1618-3169/a000495']
1858,33111740,"Reiki protocol for preoperative anxiety, depression, and well-being: a non-randomized controlled trial.","OBJECTIVE


To assess the effectiveness of Reiki in reducing anxiety, depression, and improving preoperative well-being in cardiac surgery.
METHOD


A non-randomized, two-arm controlled clinical trial conducted in a cardiology referral hospital with patients in the preoperative period of cardiac surgery, with up to five days for surgery, between May and November 2018. The intervention group (n=31) was submitted to a Reiki protocol, and the control group (n=59) received only conventional care.
RESULTS


One hundred twenty-four patients were assessed. The mean anxiety and depression did not obtain a significant difference between the groups. Spiritual well-being, in religious and existential dimensions, has improved significantly.
CONCLUSION


Anxiety and depression were lower in the intervention group, with no statistically significant difference. There was a better result in the assessment of well-being with the intervention group. Religiosity may interfere in some cases with acceptance of holistic and integrative practices. Brazilian Registry of Clinical Trials: RBR-4cxw37.",2020,The mean anxiety and depression did not obtain a significant difference between the groups.,"['One hundred twenty-four patients were assessed', 'cardiology referral hospital with patients in the preoperative period of cardiac surgery, with up to five days for surgery, between May and November 2018']","['Reiki protocol, and the control group (n=59) received only conventional care', 'Reiki protocol']","['Anxiety and depression', 'mean anxiety and depression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2712277', 'cui_str': 'Preoperative Period'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",124.0,0.0526322,The mean anxiety and depression did not obtain a significant difference between the groups.,"[{'ForeName': 'Cristovão Barros Rodrigues Dos', 'Initials': 'CBRD', 'LastName': 'Santos', 'Affiliation': 'Universidade de Pernambuco, Recife, PE, Brasil.'}, {'ForeName': 'Eduardo Tavares', 'Initials': 'ET', 'LastName': 'Gomes', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, São Paulo, SP, Brasil.'}, {'ForeName': 'Simone Maria Muniz da Silva', 'Initials': 'SMMDS', 'LastName': 'Bezerra', 'Affiliation': 'Universidade de Pernambuco, Recife, PE, Brasil.'}, {'ForeName': 'Vilanice Alves de Araújo', 'Initials': 'VAA', 'LastName': 'Püschel', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem, São Paulo, SP, Brasil.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2019012403630']
1859,33111883,"One-year evaluation of a new restorative glass ionomer cement for the restoration of non-carious cervical lesions in patients with systemic diseases: a randomized, clinical trial.","OBJECTIVE


This randomized and clinical trial aimed to evaluate the performance of a new restorative Glass Ionomer Cement (GIC) for the restoration of non-carious cervical lesions (NCCLs) of patients with systemic diseases compared with a posterior resin composite after 12 months.
METHODOLOGY


134 restorations were placed at 30 patients presenting systemic diseases by a single clinician. NCCLs were allocated to two groups according to restorative system used: a conventional restorative GIC [Fuji Bulk (GC, Tokyo Japan) (FB)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo Japan) (GP)] used with a universal adhesive using etch&rinse mode. All restorative procedures were conducted according to manufacturer's instructions. Restorations were scored regarding retention, marginal discoloration, marginal adaptation, secondary caries, surface texture, and post-operative sensitivity using modified United States Public Health Service (USPHS) criteria after 1 week (baseline), 6, and 12 months. Descriptive statistics were performed using chi-square tests. Cochran Q and Mc Nemar's tests were used to detect differences over time.
RESULTS


After 12 months, recall rate was 93% and the rates of cumulative retention failure for FB and GP were 4.9% and 1.6% respectively. Both groups presented similar alpha rates for marginal adaptation (FB 86.2%, GP 95.5%) and marginal discoloration (FB 93.8%, GP 97%) at 6-month recall, but FB restorations showed higher bravo scores than GP restorations for marginal adaptation and marginal discoloration after 12 months (p<0.05). Regarding surface texture, 2 FB restorations (3.1%) were scored as bravo after 6 months. All restorations were scored as alpha for secondary caries and postoperative sensitivity after 12 months.
CONCLUSION


Although the posterior resin composite demonstrated clinically higher alpha scores than the conventional GIC for marginal adaptation and discoloration, both materials successfully restored NCCLs at patients with systematic disease after a year.
CLINICAL RELEVANCE


Due to its acceptable clinical results, the tested conventional restorative GIC can be used for the restoration of NCCLs of patients with systemic diseases.",2020,"Although the posterior resin composite demonstrated clinically higher alpha scores than the conventional GIC for marginal adaptation and discoloration, both materials successfully restored NCCLs at patients with systematic disease after a year.
","['patients with systemic diseases', '134 restorations were placed at 30 patients presenting systemic diseases by a single clinician', 'patients with systemic diseases compared with a posterior resin composite after 12 months']","['conventional restorative GIC [Fuji Bulk (GC, Tokyo Japan) (FB)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo Japan) (GP', 'restorative Glass Ionomer Cement (GIC', 'conventional GIC', 'restorative glass ionomer cement']","['rates of cumulative retention failure', 'bravo scores', 'marginal discoloration', 'alpha scores', 'retention, marginal discoloration, marginal adaptation, secondary caries, surface texture, and post-operative sensitivity using modified United States Public Health Service (USPHS) criteria', 'alpha rates for marginal adaptation', 'recall rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0443160', 'cui_str': 'Bravo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",134.0,0.0714973,"Although the posterior resin composite demonstrated clinically higher alpha scores than the conventional GIC for marginal adaptation and discoloration, both materials successfully restored NCCLs at patients with systematic disease after a year.
","[{'ForeName': 'Fatma Dilsad', 'Initials': 'FD', 'LastName': 'Oz', 'Affiliation': 'Hacettepe University , School of Dentistry , Department of Restorative Dentistry , Sihhiye , Ankara , Turkey .'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Meral', 'Affiliation': 'Hacettepe University , School of Dentistry , Department of Restorative Dentistry , Sihhiye , Ankara , Turkey .'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ergİn', 'Affiliation': 'Hacettepe University , School of Dentistry , Department of Restorative Dentistry , Sihhiye , Ankara , Turkey .'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Gurgan', 'Affiliation': 'Hacettepe University , School of Dentistry , Department of Restorative Dentistry , Sihhiye , Ankara , Turkey .'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0311']
1860,33111988,"Repeated delivery of chlorhexidine chips for the treatment of periimplantitis: A multicenter, randomized, comparative clinical trial.","BACKGROUND


Periimplantitis is a challenging condition to manage and is frequently treated using non-surgical debridement. The local delivery of antimicrobial agents has demonstrated benefit in mild to moderate cases of periimplantitis. This study compared the safety and efficacy of Chlorhexidine gluconate 2.5 mg chip (CHX chips) as an adjunctive treatment to sub-gingival debridement in patients afflicted with periimplantitis.
METHODS


A multi-center, randomized, single-blind, two-arm, parallel Phase-3 study was conducted. Periimplantitis patients with implant pocket depths (IPD) of 5-8 mm underwent sub-gingival implant surface debridement followed by repeated bi-weekly supra-gingival plaque removal and Chlorhexidine chips application (ChxC group) for 12 weeks, or similar therapy but without application of ChxC (control group). All patients were followed for 24 weeks. Plaque and gingival indices were measured at every visit while IPD, recession and bleeding on probing were assessed at 8,12,16,24 week.
RESULTS


290 patients were included: 146 in the ChxC group and 144 in the control. At 24 weeks, a significant reduction in IPD (p = 0.01) was measured in the ChxC group (1.76 ± 1.13 mm) compared to the control group (1.54 ± 1.13 mm). IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (p = 0.03). Changes in gingival recession (0.29 ± 0.68 mm vs. 0.15 ± 0.55 mm, p = 0.015) and relative attachment gain (1.47 ± 1.32 mm and 1.39 ± 1.27 mm, p = 0.0017) were significantly larger in the ChxC group. Patients in the ChxC group that were <65 years exhibited significantly better responses (p<0.02); likewise, non-smokers had similarly better response (p <0.02). Both protocols were well tolerated, and no severe treatment-related adverse events were recorded throughout the study.
CONCLUSIONS


Patients with periimplantitis that were treated with an intensive treatment protocol of bi-weekly supra-gingival plaque removal and local application of Chlorhexidine chips had greater mean IPD reduction and greater percentile of sites with IPD reduction of ≥2 mm. as compared to bi-weekly supra-gingival plaque removal. (Clinicaltrials.gov NCT02080403). This article is protected by copyright. All rights reserved.",2020,"IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (p = 0.03).","['290 patients were included: 146 in the ChxC group and 144 in the control', 'periimplantitis', 'patients afflicted with periimplantitis', 'Periimplantitis patients with implant pocket depths (IPD) of 5-8 mm underwent', 'Patients with periimplantitis']","['chlorhexidine chips', 'Chlorhexidine gluconate 2.5 mg chip (CHX chips', 'sub-gingival implant surface debridement followed by repeated bi-weekly supra-gingival plaque removal and Chlorhexidine chips application (ChxC group) for 12 weeks, or similar therapy but without application of ChxC (control group', 'Chlorhexidine chips']","['IPD reduction of ≥2 mm', 'mean IPD reduction', 'tolerated, and no severe treatment-related adverse events', 'safety and efficacy', 'Plaque and gingival indices', 'Changes in gingival recession', 'relative attachment gain', 'IPD']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C2608961', 'cui_str': 'chlorhexidine gluconate 2.5 MG'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",290.0,0.0614733,"IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (p = 0.03).","[{'ForeName': 'Eli E', 'Initials': 'EE', 'LastName': 'Machtei', 'Affiliation': 'Department of Periodontology, School of Graduate Dentistry, Rambam health care campus, Faculty of Medicine, Technion (I.I.T.), Haifa, Israel.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Romanos', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, NY, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Division of Periodontics, Section of Oral, Diagnostic and Rehabilitation Sciences, College of Dental Medicine, Columbia University, NY, USA.'}, {'ForeName': 'Suncica', 'Initials': 'S', 'LastName': 'Travan', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Periodontics, Justus-Liebig University, Giessen & Avadent, Bad Homburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Papathannasiou', 'Affiliation': 'Division of Oral Medicine, Tufts University School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tatarakis', 'Affiliation': 'Center for Oral Clinical Research, Institute of Dentistry, Barts & The Royal London School of Medicine and Dentistry, Queen Mary University of London (QMUL), London, UK.'}, {'ForeName': 'Moshik', 'Initials': 'M', 'LastName': 'Tandlich', 'Affiliation': 'Department of Periodontology, the Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'LeilLiberman', 'Affiliation': 'Central Texas Veterans Health Care System, Texas, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Horwitz', 'Affiliation': 'Department of Periodontology, School of Graduate Dentistry, Rambam health care campus, Faculty of Medicine, Technion (I.I.T.), Haifa, Israel.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Bassir', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, NY, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Myneni', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, NY, USA.'}, {'ForeName': 'Harlan J', 'Initials': 'HJ', 'LastName': 'Shiau', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland, School of Dentistry, MD, USA.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': 'Department of Periodontology, the Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Donos', 'Affiliation': 'Center for Oral Clinical Research, Institute of Dentistry, Barts & The Royal London School of Medicine and Dentistry, Queen Mary University of London (QMUL), London, UK.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Papas', 'Affiliation': 'Division of Oral Medicine, Tufts University School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontics, Justus-Liebig University, Giessen & Avadent, Bad Homburg, Germany.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Giannobile', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine Infection and Immunity, Harvard School of Dental Medicine, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Panos N', 'Initials': 'PN', 'LastName': 'Papapanou', 'Affiliation': 'Division of Periodontics, Section of Oral, Diagnostic and Rehabilitation Sciences, College of Dental Medicine, Columbia University, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine Infection and Immunity, Harvard School of Dental Medicine, Harvard University, Boston, MA, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0353']
1861,33112004,"Footbath as a safe, simple, and non-pharmacological method to improve sleep quality of menopausal women.","Due to the adverse effects of medication we decided to provide a safe, economic, and easy intervention to decrease sleep problems in menopausal women. This trial aimed to determine the effect of footbath on sleep disturbance in postmenopausal women. One hundred menopausal women were randomly stratified using a permuted block randomization procedure by Random Allocation Software, and assigned to one of two study groups: control (without intervention, n = 50) and intervention (footbath, n = 50). The footbath group was asked to lie their feet into the warm water for 20 min in a container with a depth of 10 cm one hour before the usual sleeping time for 6 weeks. To assess sleep quality, we used the Pittsburgh sleep quality index (PSQI). To evaluate severity of menopause symptoms, the Greene scale was applied. Before the intervention, 96% of the subjects in the footbath group and 94% in the control group were poor sleepers. The results of analysis of covariance showed significant improvement in sleep quality and decrease in severity of menopause signs in the footbath group compared to the control group. At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001, r = .464). The present study findings showed that footbath intervention enhanced sleep quality in menopausal women. Thus, footbath as a safe, simple, and non-pharmacological application can improve quality of life in postmenopausal women and inhibit problems due to inadequate sleep quality.",2020,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","['One hundred menopausal women', 'menopausal women', 'postmenopausal women']","['control (without intervention, n\u2009=\u200950) and intervention (footbath, n\u2009=\u200950', 'footbath', 'footbath intervention', 'Footbath']","['severity of menopause signs', 'sleep problems', 'severity of menopause signs and the global score of PSQI', 'sleep disturbance', 'quality of life', 'Pittsburgh sleep quality index (PSQI', 'sleep quality']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",100.0,0.0295432,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammadi', 'Affiliation': 'Department of Nutrition, Khlkhal University of Medical Sciences, Khalkhal, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Salmani', 'Affiliation': 'Department of Midwifery, Khlkhal University of Medical Sciences, Khalkhal, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Ivanbagha', 'Affiliation': 'Department of Midwifery, Khlkhal University of Medical Sciences, Khalkhal, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Effati Daryani', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Nasiri', 'Affiliation': 'Department of Medical-Surgical Nursing, Khlkhal University of Medical Sciences, Khalkhal, Iran.'}]",Research in nursing & health,['10.1002/nur.22082']
1862,33112022,Is Valsalva maneuver an alternative to use tenaculum for endometrial sampling procedure in cases where the cervix cannot be passed spontaneously with pipelle? A randomized study.,"AIM


To evaluate the effect of the Valsalva maneuver on ease of the endometrial sampling procedure in cases where the cervix cannot be passed spontaneously.
METHODS


A randomized prospective trial was conducted in 84 patients whose cervix could not pass spontaneously with pipelle, and they were randomized for the Valsalva maneuver or tenaculum groups. In 43 of a total of 84 patients, we requested Valsalva maneuver throughout the process to pass the cervical canal, and in 41 patients, we performed tenaculum to pass the cervix.
RESULTS


Valsalva and tenaculum groups did not differ in success rates (P = 0.314). There was no difference between the two groups in the history of the disease, past surgery and education (P > 0.05).
CONCLUSION


In endometrial sampling procedure with pipelle, when the cervix cannot be passed spontaneously, the transition with the Valsalva maneuver should be tried before using the tenaculum. Thus, a more painful procedure can be avoided and patient satisfaction may increase.",2020,"There was no difference between the two groups in the history of the disease, past surgery and education (P > 0.05).
","['84 patients whose cervix could not pass spontaneously with pipelle, and they were randomized for the Valsalva maneuver or tenaculum groups']",['Valsalva maneuver'],"['success rates', 'history of the disease, past surgery and education']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",84.0,0.0224474,"There was no difference between the two groups in the history of the disease, past surgery and education (P > 0.05).
","[{'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Narin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Adana City Education and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Gülsüm', 'Initials': 'G', 'LastName': 'Uysal', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Adana City Education and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Baş', 'Affiliation': 'Department of Gynecologic Oncology, University of Health Sciences, Adana City Education and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Mehmet A', 'Initials': 'MA', 'LastName': 'Narin', 'Affiliation': 'Department of Gynecologic Oncology, University of Health Sciences, Adana City Education and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Emine G', 'Initials': 'EG', 'LastName': 'Küçükbingöz', 'Affiliation': 'Department of Obstetrics and Gynecology, Karaisalı State Hospital, Adana, Turkey.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14546']
1863,33112025,Optimal Handling of the Patella in Tourniquet-Free Total Knee Arthroplasty: Eversion or Lateral Retraction?,"OBJECTIVE


To explore the optimal handling of the patella during total knee arthroplasty (TKA) without the intraoperative application of a tourniquet.
METHODS


A total of 104 patients undergoing primary unilateral TKA without the intraoperative use of tourniquets from December 2018 to March 2019 in our center were included in this prospective randomized double-blinded study, including 42 men and 62 women with a mean age of 66.3 ± 7.8 years and a minimum follow-up of 1 year. Patients were randomly divided into an eversion group (n = 52) and a retraction group (n = 52) based on the intraoperative handling of the patella (eversion or lateral retraction). Primary outcome measures, including the visual analog scale at rest (rVAS) and the visual analog scale in motion (mVAS) for both anterior knee pain and thigh pain, opioid consumption, active range of motion (aROM), passive range of motion (pROM), the time needed for return of the straight-leg raise (SLR), and 90° knee flexion, were recorded by an independent observer, who also noted secondary outcome measures, including operation time, length of stay (LOS), patella-related (patellar tilt and baja) and other complications, knee swelling, Hospital for Special Surgery (HSS) scores, and the 12-item Short Form Health Survey (SF-12) scores.
RESULTS


There were no significant differences between the two groups in terms of baseline parameters. At 24, 48, and 72 h postoperatively (PO), patients in the eversion group experienced more severe thigh pain than those in the retraction group (24 h: 2.6 ± 0.8 vs 2.2 ± 0.5 [P = 0.003]; 48 h: 2.0 ± 0.5 vs 1.8 ± 0.4 [P = 0.026]; 72 h: 1.1 ± 0.4 vs 0.9 ± 0.5 [P = 0.012], respectively) and consumed more opioids (24 h: 22.3 ± 7.7 vs 15.1 ± 8.9 mg [P < 0.001]; 48 h: 27.3 ± 9.3 vs 21.4 ± 10.5 mg [P = 0.003]; 72 h: 23.1 ± 8.2 vs 19.8 ± 7.6 mg [P = 0.036], respectively), but no significant difference was found in anterior knee pain (both rVAS and mVAS) preoperatively or at 24, 48 or 72 h, 3 weeks, 2 or 6 months, or 1 year PO (P > 0.05). Throughout the 1-year follow-up, patients in the retraction group showed significantly better function, including greater aROM and pROM at all time points (P < 0.05) and a shorter period of time needed for return to SLR (1.9 ± 0.7 vs 2.2 ± 0.8 days [P = 0.044]) and 90° knee flexion (1.2 ± 0.7 vs 1.9 ± 0.8 days [P < 0.001]). In addition, no between-group difference was found in operation time, complication rate, swelling of the knee, or SF-12 score during the follow-up period (P > 0.05). The eversion group had a significantly longer LOS (5.61 ± 1.92 vs 4.93 ± 1.45 days [P = 0.044]) and worse HSS score within 2 months PO (3 weeks PO: 77.4 ± 7.6 vs 81.7 ± 7.2 [P = 0.004]; 2 months PO: 85.1 ± 7.2 vs 88.5 ± 6.1 [P = 0.011]), but at the third follow-up (6 months PO), the HSS score in the two groups became comparable (P > 0.05). No patellar tilt occurred in either group and there was only one case of patellar baja in the eversion group, with no significant between-group difference (P > 0.05).
CONCLUSION


We recommend lateral retraction rather than eversion for optimal handling of the patella during TKA because the postoperative functional recovery is better and thigh pain is relatively less severe.",2020,"No patellar tilt occurred in either group and there was only one case of patellar baja in the eversion group, with no significant between-group difference (P > 0.05).
","['104 patients undergoing primary unilateral TKA without the intraoperative use of tourniquets from December 2018 to March 2019 in our center', '42 men and 62 women with a mean age of 66.3\u2009±\u20097.8\u2009years and a minimum follow-up of 1\u2009year']","['total knee arthroplasty (TKA', 'retraction group (n = 52) based on the intraoperative handling of the patella (eversion or lateral retraction']","['HSS score', 'shorter period of time needed for return to SLR', 'anterior knee pain', 'severe thigh pain', 'operation time, complication rate, swelling of the knee, or SF-12 score', 'patellar tilt', 'longer LOS', 'patellar baja', 'greater aROM and pROM', 'visual analog scale at rest (rVAS) and the visual analog scale in motion (mVAS) for both anterior knee pain and thigh pain, opioid consumption, active range of motion (aROM), passive range of motion (pROM), the time needed for return of the straight-leg raise (SLR), and 90° knee flexion', 'operation time, length of stay (LOS), patella-related (patellar tilt and baja) and other complications, knee swelling, Hospital for Special Surgery (HSS) scores, and the 12-item Short Form Health Survey (SF-12) scores']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",104.0,0.0854987,"No patellar tilt occurred in either group and there was only one case of patellar baja in the eversion group, with no significant between-group difference (P > 0.05).
","[{'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Haoyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.'}]",Orthopaedic surgery,['10.1111/os.12819']
1864,33113571,[TITAN study: evaluation of apalutamide in patients with metastatic hormone-sensitive prostate cancer - Treatment of metastatic hormone-sensitive prostate cancer (mHSPC)].,"The TITAN study, which compares apalutamide plus ADT with placebo plus ADT in an all-comers population of patients with metastatic hormone-sensitive prostate cancer (mHSPC), reached both primary endpoints, rPFS and OS, at the first planned interim analysis 1. After a median follow-up of 22.7 months, the risk of radiographic progression was reduced by 52 % (p < 0.001) 1. The rPFS benefit was observed in all subgroups and independently of tumour burden or docetaxel pre-treatment 1. The OS interim analysis showed a mortality risk reduced by 33 % in favour of apalutamide plus ADT (p = 0.0053) 1. The secondary endpoint of time to cytotoxic chemotherapy as well as the exploratory endpoints of time to PSA progression and second progression-free survival (PFS2), defined as time between randomisation and second disease progression or death under the first subsequent therapy, were also significantly improved 1 2. Overall, apalutamide showed good tolerability, with a higher rate of apalutamide-typical rash and hypothyroidism but no relevant increase in fatigue, falls or fractures compared with placebo, and with quality of life being maintained 1. Apalutamide plus ADT can thus be an effective and well-tolerated new treatment option in many patients with mHSPC.",2020,"After a median follow-up of 22.7 months, the risk of radiographic progression was reduced by 52 % (p < 0.001) 1.","['patients with metastatic hormone-sensitive prostate cancer (mHSPC', 'patients with mHSPC', 'patients with metastatic hormone-sensitive prostate cancer - Treatment of metastatic hormone-sensitive prostate cancer (mHSPC']","['apalutamide', 'placebo', 'Apalutamide plus ADT', 'placebo plus ADT']","['fatigue, falls or fractures', 'time to cytotoxic chemotherapy as well as the exploratory endpoints of time to PSA progression and second progression-free survival (PFS2), defined as time between randomisation and second disease progression or death under the first subsequent therapy', 'mortality risk', 'risk of radiographic progression', 'rate of apalutamide-typical rash and hypothyroidism', 'rPFS benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}]",,0.0192678,"After a median follow-up of 22.7 months, the risk of radiographic progression was reduced by 52 % (p < 0.001) 1.","[{'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Urology, Lübeck.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Suttmann', 'Affiliation': 'Urologikum Hamburg, Standort Eppendorf, Hamburg.'}]",Aktuelle Urologie,['10.1055/a-1076-3036']
1865,33113596,Randomized Controlled Trial of Riluzole Augmentation for Posttraumatic Stress Disorder: Efficacy of a Glutamatergic Modulator for Antidepressant-Resistant Symptoms.,"OBJECTIVE


Current pharmacologic treatments for posttraumatic stress disorder (PTSD) have shown limited efficacy, prompting a call to investigate new classes of medications. The current study investigated the efficacy of glutamate modulation with riluzole augmentation for combat-related PTSD symptoms resistant to treatment with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
METHODS


A randomized, double-blind, placebo-controlled, parallel trial was conducted at Walter Reed National Military Medical Center and Syracuse VA Medical Center between December 2013 and November 2017. Veterans and active duty service members with combat-related PTSD (per the Clinician Administered PTSD Scale [CAPS]) who were not responsive to SSRI or SNRI pharmacotherapy were randomized to 8-week augmentation with a starting dose of 100 mg/d of riluzole (n = 36) or placebo (n = 38) and assessed weekly for PTSD symptoms, anxiety, depression, disability, and side effects.
RESULTS


Intent-to-treat analyses (N = 74) of the primary outcome (CAPS for DSM-IV) showed no significant between-group difference in change in overall PTSD symptoms (F = 0.64, P = .422), with a small effect size (d = 0.25). There was clinically significant within-group improvement in overall PTSD symptoms in both groups, with a greater mean (SD) decrease in CAPS score in the riluzole group (-21.1 [18.9]) than in the placebo group (-16.7 [17.2]). Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
CONCLUSIONS


Although preliminary, the exploratory findings of this study offer some evidence that riluzole augmentation of an SSRI or SNRI may selectively improve PTSD hyperarousal symptoms without changes in overall PTSD symptoms, depression, anxiety, or disability. Additional investigation of the mechanism of the efficacy of riluzole for hyperarousal symptoms is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02155829.",2020,"Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
","['posttraumatic stress disorder (PTSD', 'Posttraumatic Stress Disorder', 'Veterans and active duty service members with combat-related PTSD (per the Clinician Administered PTSD Scale [CAPS]) who were not responsive to SSRI or SNRI pharmacotherapy', 'Walter Reed National Military Medical Center and Syracuse VA Medical Center between December 2013 and November 2017']","['Riluzole Augmentation', 'selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs', 'riluzole', 'placebo', 'riluzole augmentation']","['overall PTSD symptoms, depression, anxiety, or disability', 'depression, anxiety, or disability severity', 'PTSD symptoms, anxiety, depression, disability, and side effects', 'overall PTSD symptoms', 'PTSD Checklist-Specific-Subscale D', 'PTSD hyperarousal symptoms', 'CAPS score', 'hyperarousal symptoms']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.270344,"Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
","[{'ForeName': 'Patricia T', 'Initials': 'PT', 'LastName': 'Spangler', 'Affiliation': 'Patricia Spangler, PhD, Department of Psychiatry, Uniformed Services University, 4301 Jones Bridge Rd, Bethesda, MD 20816. patricia.spangler.ctr@usuhs.edu.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Dempsey', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Possemato', 'Affiliation': 'Veterans Administration Center for Integrated Healthcare, Syracuse, New York, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bartolanzo', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aliaga', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Vythilingam', 'Affiliation': 'Senior Mental Health Advisor, Office of the Assistant Secretary for Health, Washington, DC, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Benedek', 'Affiliation': 'Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13233']
1866,33113783,Itching Caused by TRPV3 (Transient Receptor Potential Vanilloid-3) Activator Application to Skin of Burn Patients.,"Background and objectives:  Postburn pruritus is a common complication of scars in burn patients. In our previous study, we discovered increased expression of TRPV3, TRPV4, and TRPA1. Among them, TRPV3, in particular, is predominantly expressed in the epidermis of the tissue of pruritic burn scars. We sought to evaluate the correlation between the expression of TRPV3 activators and itching after application of TRPV3 activator carvacrol over burn scars.  Materials and Methods:  Design: This was a double-blind clinical trial with non-randomized distribution.
SETTING


This study was performed in a hospital setting.
PATIENTS OR PARTICIPANTS


Patients with itching of burn scars (numerical rating scale (NRS), <3;  n  = 8; Group 1 and NRS, ≥3;  n  = 16, Group 2) and healthy volunteers ( n  = 18, Group 3) were included.
INTERVENTIONS


The investigational drug carvacrol (100%, 75%, and 50%) and control drug (10% ethanol) were applied over the scars using IQ Ultimate™ 1 × 1 cm chamber sheets.
MAIN VARIABLES OF INTEREST


The presence of pruritus, erythema, edema, and other skin lesions was evaluated. The verbal NRS scores were also compared.  Results:  Carvacrol induced more itching in Group 2 than in Groups 1 and 3. In Group 2, 100%, 75%, and 50% carvacrol caused significantly more itching (NRS score, 5.18 ± 3.04, 5.18 ± 3.04, and 4.93 ± 2.96, respectively) than that in Group 1 (NRS score, 1.00 ± 1.80, 1.00 ± 1.80, and 1.00 ± 1.80, respectively) and Group 3 (NRS score, 2.38 ± 1.94, 1.27 ± 1.32, respectively).  Conclusions:  The TRPV3 activator carvacrol can cause itching if applied over burn scars. This study can help understand the mechanism and prognosis of post-burn itching and contribute to the development of its treatment.",2020,"In Group 2, 100%, 75%, and 50% carvacrol caused significantly more itching (NRS score, 5.18 ± 3.04, 5.18 ± 3.04, and 4.93 ± 2.96, respectively) than that in Group 1 (NRS score, 1.00 ± 1.80, 1.00 ± 1.80, and 1.00 ± 1.80, respectively) and Group 3 (NRS score, 2.38 ± 1.94, 1.27 ± 1.32, respectively).  ","['Skin of Burn Patients', 'burn patients', 'Patients with itching of burn scars (numerical rating scale (NRS), <3;  n  = 8; Group 1 and NRS, ≥3;  n  = 16, Group 2) and healthy volunteers ( n  = 18, Group 3) were included']","['TRPV3 activator carvacrol', 'TRPV3']","['expression of TRPV3, TRPV4, and TRPA1', 'presence of pruritus, erythema, edema, and other skin lesions', 'verbal NRS scores']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036280', 'cui_str': 'Burn scar'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007309', 'cui_str': 'carvacrol'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0962567', 'cui_str': 'TRPV4 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0494848,"In Group 2, 100%, 75%, and 50% carvacrol caused significantly more itching (NRS score, 5.18 ± 3.04, 5.18 ± 3.04, and 4.93 ± 2.96, respectively) than that in Group 1 (NRS score, 1.00 ± 1.80, 1.00 ± 1.80, and 1.00 ± 1.80, respectively) and Group 3 (NRS score, 2.38 ± 1.94, 1.27 ± 1.32, respectively).  ","[{'ForeName': 'Hye One', 'Initials': 'HO', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jin Cheol', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, Korea.'}, {'ForeName': 'Kong', 'Initials': 'K', 'LastName': 'Yu Gyeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Burn Center, Hangang Sacred Heart Hospital, Hallym University College of Medicine, 94-200 Yeoungdeungpo-dong, Yeoungdeungpo-gu, Seoul 150-710, Korea.'}, {'ForeName': 'Kwak', 'Initials': 'K', 'LastName': 'In Suk', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Burn Center, Hangang Sacred Heart Hospital, Hallym University College of Medicine, 94-200 Yeoungdeungpo-dong, Yeoungdeungpo-gu, Seoul 150-710, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110560']
1867,33112249,Carbohydrate Counting App Using Image Recognition for Youth With Type 1 Diabetes: Pilot Randomized Control Trial.,"BACKGROUND


Carbohydrate counting is an important component of diabetes management, but it is challenging, often performed inaccurately, and can be a barrier to optimal diabetes management. iSpy is a novel mobile app that leverages machine learning to allow food identification through images and that was designed to assist youth with type 1 diabetes in counting carbohydrates.
OBJECTIVE


Our objective was to test the app's usability and potential impact on carbohydrate counting accuracy.
METHODS


Iterative usability testing (3 cycles) was conducted involving a total of 16 individuals aged 8.5-17.0 years with type 1 diabetes. Participants were provided a mobile device and asked to complete tasks using iSpy app features while thinking aloud. Errors were noted, acceptability was assessed, and refinement and retesting were performed across cycles. Subsequently, iSpy was evaluated in a pilot randomized controlled trial with 22 iSpy users and 22 usual care controls aged 10-17 years. Primary outcome was change in carbohydrate counting ability over 3 months. Secondary outcomes included levels of engagement and acceptability. Change in HbA 1c  level was also assessed.
RESULTS


Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, P=.008), reduced frequency of individual counting errors greater than 10 g (P=.047), and lower HbA 1c  levels (P=.03). Qualitative interviews and acceptability scale scores were positive. No major technical challenges were identified. Moreover, 43% (9/21) of iSpy participants were still engaged, with usage at least once every 2 weeks, at the end of the study.
CONCLUSIONS


Our results provide evidence of efficacy and high acceptability of a novel carbohydrate counting app, supporting the advancement of digital health apps for diabetes care among youth with type 1 diabetes. Further testing is needed, but iSpy may be a useful adjunct to traditional diabetes management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04354142; https://clinicaltrials.gov/ct2/show/NCT04354142.",2020,"RESULTS


Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, P=.008), reduced frequency of individual counting errors greater than 10 g (P=.047), and lower HbA 1c  levels (P=.03).","['Youth With Type 1 Diabetes', '16 individuals aged 8.5-17.0 years with type 1 diabetes', '22 iSpy users and 22 usual care controls aged 10-17 years', 'youth with type 1 diabetes']",['Carbohydrate Counting App Using Image Recognition'],"['levels of engagement and acceptability', 'carbohydrate counting ability', 'reduced frequency of individual counting errors', 'Qualitative interviews and acceptability scale scores', 'carbohydrate counting accuracy', 'Change in HbA 1c  level']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",16.0,0.155823,"RESULTS


Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, P=.008), reduced frequency of individual counting errors greater than 10 g (P=.047), and lower HbA 1c  levels (P=.03).","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Alfonsi', 'Affiliation': 'Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Elizabeth E Y', 'Initials': 'EEY', 'LastName': 'Choi', 'Affiliation': 'Inner Analytics Inc, Toronto, ON, Canada.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Arshad', 'Affiliation': 'Division of Endocrinology, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Stacie-Ann S', 'Initials': 'SS', 'LastName': 'Sammott', 'Affiliation': 'Division of Endocrinology, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Pais', 'Affiliation': 'Division of Endocrinology, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Maguire', 'Affiliation': 'Biostatistics Design and Analysis Unit, SickKids Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Palmert', 'Affiliation': 'Division of Endocrinology, Hospital for Sick Children, Toronto, ON, Canada.'}]",JMIR mHealth and uHealth,['10.2196/22074']
1868,33112254,24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial.,"BACKGROUND


Adolescent depression carries a high burden of disease worldwide, but access to care for this population is limited. Prevention is one solution to curtail the negative consequences of adolescent depression. Internet interventions to prevent adolescent depression can overcome barriers to access, but few studies examine long-term outcomes.
OBJECTIVE


This study compares CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training), an internet-based intervention, to a general health education active control for depression onset at 12 and 24 months in adolescents presenting to primary care settings.
METHODS


A 2-site randomized trial, blinded to the principal investigators and assessors, was conducted comparing Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training to health education to prevent depressive episodes in 369 adolescents (193 youths were randomly assigned to Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education) with subthreshold depressive symptoms or prior depressive episodes. Participants were recruited from primary care settings in the United States. The primary outcome was the occurrence of a depressive episode, determined by the Depression Symptom Rating. The secondary outcome was functioning, measured by the Global Assessment Scale.
RESULTS


In intention-to-treat analyses, the adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode was not statistically significant at 12 months (hazard ratio 0.77, 95% CI 0.42-1.40, P=.39) and 24 months (hazard ratio 0.87, 95% CI 0.52-1.47, P=.61). Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training provided preventive benefit for first depressive episode for those with mild hopelessness or at least moderate paternal monitoring at baseline. Global Assessment Scale scores improved comparably in both groups (intention-to-treat).
CONCLUSIONS


A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months. Further research is necessary to determine whether internet interventions have long-term benefit.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01893749; http://clinicaltrials.gov/ct2/show/NCT01893749.",2020,"CONCLUSIONS


A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months.","['Participants were recruited from primary care settings in the United States', 'Adolescents', '369 adolescents (193 youths', 'adolescents presenting to primary care settings']","['Internet interventions', 'Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education', 'Primary Care Web-Based Depression Prevention Intervention', 'Cognitive Behavioral Humanistic and Interpersonal Training to health education', 'Cognitive Behavioral Humanistic and Interpersonal Training']","['occurrence of a depressive episode, determined by the Depression Symptom Rating', 'Global Assessment Scale scores', 'adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode', 'Global Assessment Scale']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",369.0,0.159603,"CONCLUSIONS


A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Voorhees', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Tracy R G', 'Initials': 'TRG', 'LastName': 'Gladstone', 'Affiliation': 'The Robert S and Grace W Stone Primary Prevention Initiatives, Wellesley Centers for Women, Wellesley College, Boston, MA, United States.'}, {'ForeName': 'Kunmi', 'Initials': 'K', 'LastName': 'Sobowale', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'C Hendricks', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Aaby', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Terrizzi', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Canel', 'Affiliation': 'NorthShore University Health System, Evanston, IL, United States.'}, {'ForeName': 'Eumene', 'Initials': 'E', 'LastName': 'Ching', 'Affiliation': 'Harvard Vanguard, Cambridge, MA, United States.'}, {'ForeName': 'Anita D', 'Initials': 'AD', 'LastName': 'Berry', 'Affiliation': ""Almost Home Kids, Ann & Robert H Lurie Children's Hospital, Chicago, IL, United States.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cantorna', 'Affiliation': 'Franciscan Medical Specialists, Munster, IN, United States.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Eder', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Beardslee', 'Affiliation': 'Judge Baker Center, Harvard Medical School, Roxbury Crossing, MA, United States.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Marko-Holguin', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Miae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'de Forest', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Sykes', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Suor', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Crawford', 'Affiliation': 'Dr Karen Taylor-Crawford & Associates, Palos Park, IL, United States.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Burkhouse', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Brady C', 'Initials': 'BC', 'LastName': 'Goodwin', 'Affiliation': 'Department of General Pediatrics, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bell', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, College of Medicine, Chicago, IL, United States.'}]",Journal of medical Internet research,['10.2196/16802']
1869,33112264,Prediction of hyperaldosteronism subtypes when adrenal vein sampling is unilaterally successful.,"Objective


Adrenal venous sampling (AVS) is the gold standard to discriminate patients with unilateral primary aldosteronism (UPA) from bilateral disease (BPA). AVS is technically demanding and in cases of unsuccessful cannulation of adrenal veins, the results may not always be interpreted. The aim of our study was to develop diagnostic models to distinguish UPA from BPA, in cases of unilateral successful AVS and the presence of contralateral suppression of aldosterone secretion.
Design


Retrospective evaluation of 158 patients referred to a tertiary hypertension unit who underwent AVS. We randomly assigned 110 patients to a training cohort and 48 patients to a validation cohort to develop and test the diagnostic models.
Methods


Supervised machine learning algorithms and regression models were used to develop and validate two prediction models and a simple 19-point score system to stratify patients according to their subtype diagnosis.
Results


Aldosterone levels at screening and after confirmatory testing, lowest potassium, ipsilateral and contralateral imaging findings at CT scanning, and contralateral ratio at AVS, were associated with a diagnosis of UPA and were included in the diagnostic models. Machine learning algorithms correctly classified the majority of patients both at training and validation (accuracy: 82.9-95.7%). The score system displayed a sensitivity/specificity of 95.2/96.9%, with an AUC of 0.971. A flow-chart integrating our score correctly managed all patients except 3 (98.1% accuracy), avoiding the potential repetition of 77.2% of AVS procedures.
Conclusions


Our score could be integrated in clinical practice and guide surgical decision-making in patients with unilateral successful AVS and contralateral suppression.",2020,Machine learning algorithms correctly classified the majority of patients both at training and validation (accuracy 82.9-95.7%).,"['patients with unilateral primary aldosteronism (UPA) from bilateral disease (BPA', '110 patients to a training cohort and 48 patients to a validation cohort to develop and test the diagnostic models', 'patients with unilateral successful AVS and contralateral suppression', '158 patients referred to a tertiary hypertension unit who underwent AVS']",['Objective - Adrenal venous sampling (AVS'],['Aldosterone levels'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0457942', 'cui_str': 'Adrenal vein sampling catheter procedure'}]","[{'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}]",110.0,0.0340238,Machine learning algorithms correctly classified the majority of patients both at training and validation (accuracy 82.9-95.7%).,"[{'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Burrello', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Burrello', 'Affiliation': ""Department of Electrical, Electronic and Information Engineering 'Guglielmo Marconi' (DEI), University of Bologna, Bologna, Italy.""}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Pieroni', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sconfienza', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Forestiero', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Amongero', 'Affiliation': 'Department of Mathematical Sciences G. L. Lagrange, Polytechnic University of Torino, Torino, Italy.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Rossato', 'Affiliation': 'AOU Città della Salute e della Scienza - Service of Radiology, Torino, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Veglio', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Williams', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Monticone', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mulatero', 'Affiliation': 'Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Torino, Torino, Italy.'}]",European journal of endocrinology,['10.1530/EJE-20-0656']
1870,33112273,Conventional thyroidectomy versus thyroid thermal ablation on postoperative quality of life and satisfaction for patients with benign thyroid nodules.,"OBJECTIVE


The complications and treatment effects of conventional thyroidectomy and thyroid thermal ablation should be compared in order to identify the best intervention for patients with benign thyroid nodules.
METHODS


Patients (18-50 years old) who had benign thyroid nodules and were eligible for both thyroidectomy and thyroid thermal ablation were randomly allocated (1:1) to either conventional thyroidectomy group or thyroid thermal ablation group. Patients' satisfaction and condition-specific quality of life were measured with the Thyroid-Specific Quality-of-Life Questionnaire Scale (QoL) at the 15th post-randomization month and were set as the co-primary outcome.
RESULTS


A total of 450 patients were enrolled and randomized (225 patients in each group). At the 15th month after randomization, more patients in the thyroid thermal ablation group were satisfied with the treatment effects compared to those in the conventional thyroidectomy group. More patients in the thyroid thermal ablation group have a QoL score of 410 (QOL scores ranges from 0 to 410) than patients in conventional thyroidectomy. Eight (4%) of the 209 patients in conventional thyroidectomy group and 6 (3%) of the 208 patients in thyroid thermal ablation group had at least one severe postoperative complication. The time to achieve volume reduction was longer in the thermal ablation group.
CONCLUSION


Thyroid thermal ablation is superior to conventional thyroidectomy in terms of patients satisfaction, postoperative quality of life, and shorter hospital stay, but takes longer to achieve BTNs volume reduction. The complication rates between the two groups were similar.",2020,"Patients' satisfaction and condition-specific quality of life were measured with the Thyroid-Specific Quality-of-Life Questionnaire Scale (QoL) at the 15th post-randomization month and were set as the co-primary outcome.
","['patients with benign thyroid nodules', '450 patients were enrolled and randomized (225 patients in each group', 'Patients (18-50 years old) who had benign thyroid nodules and were eligible for both thyroidectomy and thyroid thermal ablation']","['conventional thyroidectomy', 'Thyroid thermal ablation', 'Conventional thyroidectomy versus thyroid thermal ablation', 'conventional thyroidectomy and thyroid thermal ablation', 'thyroid thermal ablation', 'conventional thyroidectomy group or thyroid thermal ablation group']","['QoL score of 410 (QOL scores ranges', 'volume reduction', 'postoperative quality of life and satisfaction', 'severe postoperative complication', 'Thyroid-Specific Quality-of-Life Questionnaire Scale (QoL', 'patients satisfaction, postoperative quality of life, and shorter hospital stay', 'complication rates', ""Patients' satisfaction and condition-specific quality of life""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",450.0,0.0304435,"Patients' satisfaction and condition-specific quality of life were measured with the Thyroid-Specific Quality-of-Life Questionnaire Scale (QoL) at the 15th post-randomization month and were set as the co-primary outcome.
","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ""H Jin, The Second Department of General Surgery, Zhuhai City People's Hospital, Zhuhai, China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'W Lin, Affiliated Foshan Hospital of Southern Medical University, Southern Medical University, Foshan, China.'}, {'ForeName': 'Ligong', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""L Lu, President, Zhuhai City People's Hospital, Zhuhai, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cui', 'Affiliation': ""M Cui, Vice-president, Zhuhai City People's Hospital, Zhuhai, China.""}]",European journal of endocrinology,['10.1530/EJE-20-0562']
1871,33112363,Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe: A Randomized Clinical Trial.,"Importance


Although nonparticipation in cardiac rehabilitation is known to increase cardiovascular mortality and hospital readmissions, more than half of patients with coronary artery disease in Europe are not participating in cardiac rehabilitation.
Objective


To assess whether a 6-month guided mobile cardiac rehabilitation (MCR) program is an effective therapy for elderly patients who decline participation in cardiac rehabilitation.
Design, Setting, and Participants


Patients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries. Researchers assessing primary outcome were masked for group assignment. A total of 4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation. Subsequently, 179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial. Data were analyzed from January 21 to October 11, 2019.
Interventions


Six months of home-based cardiac rehabilitation with telemonitoring and coaching based on motivational interviewing was used to stimulate patients to reach exercise goals. Control patients did not receive any form of cardiac rehabilitation throughout the study period.
Main Outcomes and Measures


The primary outcome parameter was peak oxygen uptake (Vo2peak) after 6 months.
Results


Among 179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis. Follow-up at 1 year was completed for 151 patients (84%). Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively). Changes in Vo2peak were greater in the MCR vs control groups at 6 months (+1.2 [95% CI, 0.2 to 2.1] mL/kg-1/min-1) and 12 months (+0.9 [95% CI, 0.05 to 1.8] mL/kg-1/min-1). The incidence of adverse events was low and did not differ between the MCR and control groups.
Conclusions and Relevance


These results suggest that a 6-month home-based MCR program for patients 65 years or older with coronary artery disease or a valvular intervention was safe and beneficial in improving Vo2peak when compared with no cardiac rehabilitation.
Trial Registration


trialregister.nl Identifier: NL5168.",2020,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","['Participants\n\n\nPatients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries', 'patients 65 years or older with coronary artery disease or a', '179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial', 'patients with coronary artery disease in Europe', '179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis', 'Elderly Patients in Europe', 'elderly patients who decline participation in cardiac rehabilitation', '4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation']","['Home-Based Mobile Guided Cardiac Rehabilitation', 'valvular intervention', 'telemonitoring and coaching based on motivational interviewing', 'guided mobile cardiac rehabilitation (MCR) program']","['Changes in Vo2peak', 'Peak oxygen uptake', 'cardiovascular mortality and hospital readmissions', 'peak oxygen uptake (Vo2peak', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026265', 'cui_str': 'Mitral valve disorder'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4236.0,0.13279,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","[{'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Snoek', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Eva I', 'Initials': 'EI', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'van der Velde', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Leonie F', 'Initials': 'LF', 'LastName': 'Prins', 'Affiliation': 'Diagram, Zwolle, the Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bruins', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Meindersma', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Peña-Gil', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'González-Salvado', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Feriel', 'Initials': 'F', 'LastName': 'Moatemri', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Iliou', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Thimo', 'Initials': 'T', 'LastName': 'Marcin', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Eser', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.'}, {'ForeName': 'Ed P', 'Initials': 'EP', 'LastName': 'de Kluiver', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2020.5218']
1872,33112408,Sustained efficacy of incobotulinumtoxinA in upper-limb post-stroke spasticity: A post hoc analysis.,"OBJECTIVE


This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity.
DESIGN


Data from the double-blind, placebo-controlled main period and 3 open-label extension cycles of 2 Phase 3, randomized, multicentre trials were pooled.
METHODS


Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥ 12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed.
RESULTS


Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation (SD)) AS arm sumscore improved continuously: main period: -3.23 (2.55) (placebo: -1.49 (2.09)); extension cycles 1, 2, and 3: -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.
CONCLUSION


IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb post-stroke spasticity.",2020,"Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.
","['subjects with upper-limb post-stroke spasticity', 'Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤\u2009400 Units at ≥', 'upper-limb post-stroke spasticity', '465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation (SD', 'adults with upper-limb post-stroke spasticity']","['incobotulinumtoxinA injections', 'placebo', 'incobotulinumtoxinA', 'IncobotulinumtoxinA']","['Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator', 'DAS principal target domain responder rate', 'muscle tone, disability, and caregiver burden', 'AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores', 'functional disability', 'CBS scores']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.561393,"Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.
","[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kaňovský', 'Affiliation': 'Faculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, Olomouc, Czech Republic. E-mail: petr.kanovsky@fnol.cz.'}, {'ForeName': 'Elie P', 'Initials': 'EP', 'LastName': 'Elovic', 'Affiliation': ''}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Munin', 'Affiliation': ''}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': ''}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Pulte', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': ''}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hiersemenzel', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Marciniak', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2760']
1873,33112417,Intranasal oxytocin as a treatment for chronic pelvic pain: A randomized controlled feasibility study.,"OBJECTIVES


To investigate the effect of intranasal oxytocin on chronic pelvic pain in a randomized, double-blind, within-subject crossover trial. Aims included: (1) determine intranasal oxytocin's effect on pain intensity and pain interference relative to placebo; (2) assess feasibility and acceptability.
METHODS


Women with chronic pelvic pain were recruited from chronic pain and gynecology clinics between September 2017 and December 2018. Pain was recorded at pre-trial screening, and while administering intranasal oxytocin and placebo. Pain and pain-related interference were measured using the Brief Pain Inventory - Short Form. Feasibility and acceptability were measured using validated measures and interviews.
RESULTS


Twenty-one women were randomized with sufficient data available from 12 to permit analyses. Relative to placebo, a 2-week course of oxytocin administration resulted in improvement in pain severity with no effect on pain-related interference. This effect was driven by four women who demonstrated a minimal clinically significant improvement in pain following intranasal oxytocin (no women met this threshold for placebo). Adherence to dosing was excellent and occurrence of adverse effects did not differ between oxytocin and placebo.
CONCLUSIONS


Intranasal oxytocin may represent an adjuvant analgesic that could result in a minimal clinically significant improvement in pain among one in three women with chronic pelvic pain.",2020,"Relative to placebo, a 2-week course of oxytocin administration resulted in improvement in pain severity with no effect on pain-related interference.","['three women with chronic pelvic pain', 'chronic pelvic pain', 'Twenty-one women', 'Women with chronic pelvic pain were recruited from chronic pain and gynecology clinics between September 2017 and December 2018']","['oxytocin and placebo', 'intranasal oxytocin', 'oxytocin', 'placebo', 'Intranasal oxytocin']","['Feasibility and acceptability', 'adverse effects', 'feasibility and acceptability', 'chronic pelvic pain', 'Pain', 'pain intensity and pain interference', 'pain severity', 'pain-related interference', 'Pain and pain-related interference', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",21.0,0.724594,"Relative to placebo, a 2-week course of oxytocin administration resulted in improvement in pain severity with no effect on pain-related interference.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Flynn', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rash', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, NL, Canada.""}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13441']
1874,33112433,Evaluation of daily avanafil efficacy in improving the endothelial function in Egyptian males with erectile dysfunction.,"Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor. However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the endothelial markers' serum level and erectile function in patients with erectile dysfunction. In this work, we randomly divided 140 males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction like diabetes mellitus, hypertension and dyslipidaemia into two equal groups: treatment group, treated with 50mg daily oral avanafil, and control group, treated with placebo. The International Index of Erectile Function-5 score and the serum levels of nitric oxide, cyclic guanosine monophosphate and endothelin-1 as markers of endothelial function were measured at baseline and after four weeks of treatment in both groups. At the end of treatment period, those randomised to avanafil achieved statistically significant improvement in erectile function, nitric oxide, cyclic guanosine monophosphate and endothelin-1 levels from baseline versus placebo regardless the type and duration of associated comorbidity as well as the duration and severity of erectile dysfunction. These results permitted us to suggest that daily avanafil can improve the impaired endothelial function associated with the erectile dysfunction.",2020,"The International Index of Erectile Function-5 score and the serum levels of nitric oxide, cyclic guanosine monophosphate and endothelin-1 as markers of endothelial function were measured at baseline and after four weeks of treatment in both groups.","['patients with erectile dysfunction', 'Egyptian males with erectile dysfunction', '140 males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction like diabetes mellitus, hypertension and dyslipidaemia into two equal groups: treatment group']","['daily avanafil', 'Avanafil', 'treated with 50mg daily oral avanafil, and control group, treated with placebo']","[""endothelial markers' serum level and erectile function"", 'International Index of Erectile Function-5 score and the serum levels of nitric oxide, cyclic guanosine monophosphate and endothelin-1 as markers of endothelial function', 'duration and severity of erectile dysfunction', 'endothelial function', 'erectile function, nitric oxide, cyclic guanosine monophosphate and endothelin-1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2698280', 'cui_str': 'avanafil'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",140.0,0.0454925,"The International Index of Erectile Function-5 score and the serum levels of nitric oxide, cyclic guanosine monophosphate and endothelin-1 as markers of endothelial function were measured at baseline and after four weeks of treatment in both groups.","[{'ForeName': 'Abdelaal M', 'Initials': 'AM', 'LastName': 'Elkamshoushi', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Noha M', 'Initials': 'NM', 'LastName': 'Badae', 'Affiliation': 'Department of Medical Physiology, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Kabary', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Shaimaa I', 'Initials': 'SI', 'LastName': 'Omar', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Andrologia,['10.1111/and.13833']
1875,33112463,"Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A Double-blind, Randomized Controlled Trial study.","BACKGROUND


FDA-approved drugs for the most common type of hair loss, androgenetic alopecia (AGA), present many side effects and disadvantages. However, herbal compounds are characterized by patient compliance, fewer side effects, and several mechanisms of action.
OBJECTIVE


The present study set to evaluate the effectiveness and safety of the topical herbal solution and to compare it with 5% minoxidil in men with AGA.
METHODS


A randomized, double-blind controlled trial was conducted from November 28, 2018, to September 2, 2019, in Sina Hospital, Tabriz, Iran. 24 healthy males (mean (SD) age 33.04 (5.81)) with mild to moderate AGA were selected from 44 volunteer participants. Participants were randomly assigned (1:1) into two groups. They received 1mL of topical solutions at morning and evening intervals for nine months. Primary outcomes consisted of measured hair diameters at baseline and repeated at weeks 12, 24, and 36. Furthermore, hair density was measured at baseline and week 36.
RESULTS


The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement. At week 36, the mean hair diameter of the MTS + THS group significantly increased compared to the MTS group (P=0.001). Hair density increased in both groups; however, only in the MTS + THS group, it was significant (P<0.05).
CONCLUSION


The findings established that the topical herbal solution has significant influence on patients with AGA and improvement of their quality of life. This solution can be considered a significant step towards the prevention and treatment of AGA. This article is protected by copyright. All rights reserved.",2020,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"['November 28, 2018, to September 2, 2019, in Sina Hospital, Tabriz, Iran', 'men with AGA', '24 healthy males (mean (SD) age 33.04 (5.81)) with mild to moderate AGA were selected from 44 volunteer participants']","['novel herbal solution', 'topical herbal solution', 'MTS', 'minoxidil', 'MTS + THS']","['mean hair diameter', 'Furthermore, hair density', 'measured hair diameters', 'effectiveness and safety', 'Efficacy and safety', 'quality of life', 'Hair density']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0796074', 'cui_str': 'Deafness-dystonia-optic neuronopathy syndrome'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",24.0,0.29193,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Masoud', 'Affiliation': 'Student Research Committee and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Azimi Alamdari', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Asnaashari', 'Affiliation': 'Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Biotechnology Research Center, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Javadzadeh', 'Affiliation': 'Biotechnology Research Center, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Dermatologic therapy,['10.1111/dth.14467']
1876,33108238,Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE).,"PURPOSE


In this phase II response-adaptive trial, we investigated the rational application of immune checkpoint blockade in renal cell carcinoma (RCC; ClinicalTrials.gov identifier: NCT03203473).
METHODS


We enrolled patients with metastatic RCC with no prior checkpoint inhibitor exposure. All patients received nivolumab alone with subsequent arm allocation based on response. Patients with a confirmed partial response (PR) or complete response (CR) within 6 months discontinued nivolumab and were observed (arm A). Patients with stable disease or progressive disease (PD) after no more than 6 months of nivolumab received two doses of ipilimumab (arm B). The primary endpoints were the proportion of patients with PR/CR at 1 year after nivolumab discontinuation (arm A) and proportion of nivolumab nonresponders who converted to PR/CR after ipilimumab (arm B).
RESULTS


Overall, 83 patients initiated treatment, of whom 96% had clear-cell histology, 51% were treatment naïve, and 67% had intermediate/poor-risk disease. Median follow-up was 19.5 months. Within 6 months, induction nivolumab resulted in a confirmed PR in 12% of patients (n = 10). Fourteen patients were not allocated to a study arm (seven because of toxicity, seven because of PD). Twelve patients (14%) were allocated to arm A and discontinued nivolumab, of whom five (42%; 90% CI, 18% to 68%) remained off nivolumab at ≥ 1 year. Of 57 patients (69%) allocated to arm B, two patients converted to a confirmed PR (4%; 90% CI, 1% to 11%), and no CRs were observed.
CONCLUSION


In this study, nivolumab followed by two doses of ipilimumab resulted in no CRs and a low PR/CR conversion. The number of patients evaluated for nivolumab discontinuation was too small to assess the value of this approach. Currently, our data do not support a response-adaptive strategy for checkpoint blockade in advanced RCC.",2020,"Within 6 months, induction nivolumab resulted in a confirmed PR in 12% of patients (n = 10).","['Fourteen patients', 'enrolled patients with metastatic RCC with no prior checkpoint inhibitor exposure', 'Patients with stable disease or progressive disease (PD) after no more than 6 months of nivolumab received two doses of', 'Advanced Renal Cell Carcinoma']","['ipilimumab', 'Nivolumab and Ipilimumab', 'nivolumab alone']","['partial response (PR) or complete response (CR', 'clear-cell histology', 'proportion of patients with PR/CR']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",14.0,0.147047,"Within 6 months, induction nivolumab resulted in a confirmed PR in 12% of patients (n = 10).","[{'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'McGregor', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Braun', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Christos E', 'Initials': 'CE', 'LastName': 'Kyriakopoulos', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Zakharia', 'Affiliation': 'University of Iowa Health Care, Holden Comprehensive Cancer Center, Iowa City, IA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Maughan', 'Affiliation': 'University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Rose', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Harshman', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02295']
1877,33108244,"Effect of rhG-CSF Combined With Decitabine Prophylaxis on Relapse of Patients With High-Risk MRD-Negative AML After HSCT: An Open-Label, Multicenter, Randomized Controlled Trial.","PURPOSE


Relapse is a major cause of treatment failure after allogeneic hematopoietic stem-cell transplantation (allo-HSCT) for high-risk acute myeloid leukemia (HR-AML). The aim of this study was to explore the effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) combined with minimal-dose decitabine (Dec) on the prevention of HR-AML relapse after allo-HSCT.
PATIENTS AND METHODS


We conducted a phase II, open-label, multicenter, randomized controlled trial. Two hundred four patients with HR-AML who had received allo-HSCT 60-100 days before randomization and who were minimal residual disease negative were randomly assigned 1:1 to either rhG-CSF combined with minimal-dose Dec (G-Dec group: 100 µg/m 2  of rhG-CSF on days 0-5 and 5 mg/m 2  of Dec on days 1-5) or no intervention (non-G-Dec group). The primary outcome was relapse after transplantation, and the secondary outcomes were chronic graft-versus-host disease (cGVHD), safety of the treatment, and survival.
RESULTS


The estimated 2-year cumulative incidence of relapse in the G-Dec group was 15.0% (95% CI, 8.0% to 22.1%), compared with 38.3% (95% CI, 28.8% to 47.9%) in the non-G-Dec group ( P  < .01), with a hazard ratio (HR) of 0.32 (95% CI, 0.18 to 0.57;  P  < .01). There was no statistically significant difference between the G-Dec and non-G-Dec groups in the 2-year cumulative incidence of cGVHD without relapse (23.0% [95% CI, 14.7% to 31.3%] and 21.7% [95% CI, 13.6% to 29.7%], respectively;  P  = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92;  P  = .81). After rhG-CSF combined with minimal-dose Dec maintenance, increasing numbers of natural killer, CD8+ T, and regulatory T cells were observed.
CONCLUSION


Our findings suggest that rhG-CSF combined with minimal-dose Dec maintenance after allo-HSCT can reduce the incidence of relapse, accompanied by changes in the number of lymphocyte subtypes.",2020,"There was no statistically significant difference between the G-Dec and non-G-Dec groups in the 2-year cumulative incidence of cGVHD without relapse (23.0% [95% CI, 14.7% to 31.3%] and 21.7% [95% CI, 13.6% to 29.7%], respectively;  P  = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92;  P  = .81).","['Patients With High-Risk MRD-Negative AML', 'Two hundred four patients with HR-AML who had received allo-HSCT 60-100 days before randomization and who were minimal residual disease negative']","['allogeneic hematopoietic stem-cell transplantation (allo-HSCT', 'HSCT', 'recombinant human granulocyte colony-stimulating factor (rhG-CSF) combined with minimal-dose decitabine (Dec', 'rhG-CSF Combined With Decitabine Prophylaxis', 'rhG-CSF combined with minimal-dose Dec (G-Dec group: 100 µg/m 2  of rhG-CSF on days 0-5 and 5 mg/m 2  of Dec on days 1-5) or no intervention']","['relapse after transplantation', 'incidence of relapse', '2-year cumulative incidence of relapse', 'HR-AML relapse', '2-year cumulative incidence of cGVHD without relapse', 'numbers of natural killer, CD8+ T, and regulatory T cells', 'chronic graft-versus-host disease (cGVHD), safety of the treatment, and survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",204.0,0.260593,"There was no statistically significant difference between the G-Dec and non-G-Dec groups in the 2-year cumulative incidence of cGVHD without relapse (23.0% [95% CI, 14.7% to 31.3%] and 21.7% [95% CI, 13.6% to 29.7%], respectively;  P  = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92;  P  = .81).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Health Statistics, College of Military Preventive Medicine, Army Medical University, Chongqing, China.'}, {'ForeName': 'Sanbin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, General Hospital of Kunming Military Region of the People's Liberation Army (PLA), Kunming, China.""}, {'ForeName': 'Peiyan', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Hematology, General Hospital of Chengdu Military Region of the PLA, Chengdu, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, the Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Department of Hematology, General Hospital of Lanzhou Military Region of the PLA, Lanzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Lang', 'Affiliation': ""Department of Hematology, Xinjiang Provincial People's Hospital, Urumqi, China.""}, {'ForeName': 'Jishi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Guiyang Medical University, Guiyang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Hematology, Tangdu Hospital, Forth Military Medical University (Air Force Medical University), Xi'an, China.""}, {'ForeName': 'Tonghua', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Yunnan Provincial People's Hospital, Kunming, China.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, General Hospital of Chengdu Military Region of the PLA, Chengdu, China.'}, {'ForeName': 'Shifeng', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Department of Hematology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': ""Department of Hematology, Xinjiang Provincial People's Hospital, Urumqi, China.""}, {'ForeName': 'Cunbang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, General Hospital of Lanzhou Military Region of the PLA, Lanzhou, China.'}, {'ForeName': 'Xianlin', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Department of Hematology, the Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""Department of Hematology, General Hospital of Kunming Military Region of the People's Liberation Army (PLA), Kunming, China.""}, {'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Kaniel', 'Initials': 'K', 'LastName': 'Cassady', 'Affiliation': 'Departments of Diabetes Immunology and Hematology/Hematopoietic Cell Transplantation, Beckman Research Institute, City of Hope, Duarte, CA.'}, {'ForeName': 'Jiang F', 'Initials': 'JF', 'LastName': 'Zhong', 'Affiliation': 'Department of Otolaryngology, Keck School of Medicine, University of Southern California, CA.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03277']
1878,33108247,"Psychometric evaluation of the medication adherence report scale in caregivers of low-income, urban, African American children with poorly controlled asthma.","OBJECTIVE


Accurately assessing asthma medication usage among low-income, urban, African American children is essential to reduce asthma health disparities. The purpose of this study was to examine the factor structure of the five-item Medication Adherence Report Scale (MARS), in a sample of caregivers of low-income, urban, African American youth with poorly controlled asthma.
METHOD


Using baseline data from a randomized clinical trial evaluating the efficacy of an environmental control educational intervention, confirmatory factor analysis (CFA) was conducted to ascertain the MARS factor structure. Construct validity was assessed using a regression model inclusive of caregiver-reported medication adherence, Asthma Medication Ratio (AMR), asthma control, and caregiver perception of asthma control as predictors of the MARS.
RESULTS


Caregivers were female (97%) and 27.4% had an annual income under $10,000. The mean MARS score was 21.88 ± 3.33 out of a possible range of 5-25, representing high adherence. Confirmatory factor analysis indicated that a five-item one-factor model marginally fit the data based on the fit indices:  χ   2  (5) = 31.71,  p  < 0.001; RMSEA ≤ 0.161; CFI = 0.986; TLI = 0.971; and WRMR = 0.979. The MARS was associated with another caregiver-reported measure of medication adherence but not associated with AMR, asthma control, or caregiver perception of asthma control.
CONCLUSIONS


The MARS demonstrated marginal fit in CFA and may not be clinically indicated in light of the lack of associations with objective measures of asthma medication adherence and asthma control.",2020,"The MARS was associated with another caregiver-reported measure of medication adherence but not associated with AMR, asthma control, or caregiver perception of asthma control.  ","['low-income, urban, African American children', 'caregivers of low-income, urban, African American youth with poorly controlled asthma', 'Caregivers of Low-income, Urban, African American Children with Poorly Controlled Asthma']","['environmental control educational intervention, confirmatory factor analysis (CFA', 'five-item Medication Adherence Report Scale (MARS']","['AMR, asthma control, or caregiver perception of asthma control', 'medication adherence, Asthma Medication Ratio (AMR), asthma control, and caregiver perception of asthma control', 'mean MARS score', 'medication adherence']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C1706799', 'cui_str': 'amrubicin hydrochloride'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0476334,"The MARS was associated with another caregiver-reported measure of medication adherence but not associated with AMR, asthma control, or caregiver perception of asthma control.  ","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Margolis', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Bellin', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dababnah', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sacco', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics, The Johns Hopkins University School of Medicine, Freeland, MI, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1841226']
1879,33108379,Improved nutrition in early life and pulse wave velocity and augmentation index in mid-adulthood: Follow-up of the INCAP Nutrition Supplementation Trial Longitudinal Study.,"Nutrition in pregnancy and early childhood affects later blood pressure and precursors of atherosclerosis, but its influence on arterial stiffness is unexplored. This study determines whether exposure to improved nutrition during early life influences Augmentation index (AI) and pulse wave velocity (PWV) in mid-adulthood. We included 1221 adults (37-54y) who participated in a cluster-randomized nutritional supplementation trial of a protein-energy beverage (Atole), conducted between 1969-1977 in Guatemala. The comparison group received Fresco, a low-calorie protein-free beverage. In 2015-17, we measured anthropometry (weight, height, and waist-to-height ratio); AI and PWV (using carotid-femoral tonometry); blood pressure; fasting plasma glucose and serum lipids; and sociodemographic characteristics. Based on patterns of exposure, we characterized participants as fully, partially or unexposed to the intervention from conception to their second birthday (the 'first 1000 days'). We fit pooled and sex-specific models using intention-to-treat, difference-in-difference regression analysis to test whether exposure to the supplement in the first 1000 days was associated with AI and PWV in adulthood adjusting for basal and current sociodemographic variables and current life-style and cardio-metabolic risk factors. Prevalence of obesity in men and women was 39.6% and 19.6%, and prevalence of hypertension was 44.0% and 36.0%, respectively. Women had higher AI (34.4±9.6%) compared to men (23.0± 9.8%), but had similar PWV (7.60±1.13 m/s and 7.60±1.31, respectively). AI did not differ significantly across intervention groups. PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals. This difference was similar after adjusting for cardio-metabolic risk factors (-0.45m/s; 95%C-0.93, 0.01; p = 0.06). Exposure to improved nutrition during the first 1000 days was marginally associated with lower PWV, but not with AI.",2020,"PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals.","['mid-adulthood', '1221 adults (37-54y) who participated in a cluster-randomized nutritional supplementation trial of a protein-energy beverage (Atole), conducted between 1969-1977 in Guatemala']","['Fresco, a low-calorie protein-free beverage']","['Improved nutrition in early life and pulse wave velocity and augmentation index', 'Prevalence of obesity', 'cardio-metabolic risk factors', 'anthropometry (weight, height, and waist-to-height ratio); AI and PWV (using carotid-femoral tonometry); blood pressure; fasting plasma glucose and serum lipids; and sociodemographic characteristics', 'Augmentation index (AI) and pulse wave velocity (PWV', 'prevalence of hypertension', 'PWV']","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1221.0,0.0587138,"PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals.","[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Kroker-Lobos', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Ford', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gonzalez-Casanova', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0239921']
1880,33114379,Randomized Phase II Study with Cetuximab in Combination with 5-FU and Cisplatin or Carboplatin vs. Cetuximab in Combination with Paclitaxel and Carboplatin for Treatment of Patients with Relapsed or Metastatic Squamous Cell Carcinoma of the Head and Neck (CETMET Trial).,"BACKGROUND


Platinum-based chemotherapy with cetuximab is the standard of care for relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN). The aim of this trial was to investigate whether cetuximab and paclitaxel/carboplatin can achieve similar progression-free survival (PFS) with standard cetuximab and 5-FU/platinum-based chemotherapy. Standard chemotherapy treatment for SCCHN is related to severe toxicity and new, less toxic regimens are needed.
METHODS


In this multicentre, randomized, controlled, phase 2 trial, 85 patients with relapsed or metastatic SCCHN were randomized in a 1:1 ratio to cetuximab and 5-FU/cisplatin or carboplatin (arm A) vs. cetuximab and paclitaxel/carboplatin (arm B). Eligibility criteria included age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1, and adequate organ functions. The primary endpoint was to investigate whether PFS in arm B is significantly worse than PFS in arm A.
RESULTS


Median PFS in arm A was 4.37 months (95% CI: 2.9-5.9 m) and 6.5 months (95% CI: 4.8-8.2 m) in arm B, ( p  = 0.064). Median overall survival (OS) was 8.4 months (95% CI: 5.3-11.5 m) in arm A and 10.2 months (95% CI: 5.4-15 m) in arm B, (HR = 0.71; 95% CI: 0.43-1.16). PFS HR for arm B was not significantly worse than arm A (HR = 0.65; 95% CI: 0.41-1.03). Adverse events ≥ grade 3 were more frequent in arm A than arm B (60% vs. 40%;  p  = 0.034).
CONCLUSION


Cetuximab and paclitaxel/carboplatin was found to have similar efficacy and less toxicity compared to cetuximab and 5-FU/cisplatin or carboplatin. The experimental arm is easier to administer rendering it a favorable alternative to standard therapy.",2020,"Median overall survival (OS) was 8.4 months (95% CI: 5.3-11.5 m) in arm A and 10.2 months (95% CI: 5.4-15 m) in arm B, (HR = 0.71; 95% CI: 0.43-1.16).","['Patients with Relapsed or Metastatic Squamous Cell Carcinoma of the Head and Neck (CETMET Trial', '85 patients with relapsed or metastatic SCCHN', 'Eligibility criteria included age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1, and adequate organ functions', 'relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN']","['Cetuximab', 'Paclitaxel and Carboplatin', 'cetuximab and paclitaxel/carboplatin', 'Platinum-based chemotherapy with cetuximab', '5-FU/cisplatin or carboplatin', 'cetuximab and 5-FU/cisplatin or carboplatin (arm A) vs. cetuximab and paclitaxel/carboplatin (arm B', 'Cetuximab and paclitaxel/carboplatin', '5-FU and Cisplatin or Carboplatin vs. Cetuximab', 'standard cetuximab and 5-FU/platinum-based chemotherapy']","['toxicity', 'Median overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",85.0,0.0719996,"Median overall survival (OS) was 8.4 months (95% CI: 5.3-11.5 m) in arm A and 10.2 months (95% CI: 5.4-15 m) in arm B, (HR = 0.71; 95% CI: 0.43-1.16).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsakonas', 'Affiliation': 'Theme Cancer, Medical Unit Head&Neck, Lung and Skin Cancer, Karolinska University Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Specht', 'Affiliation': 'Rigshospitalet, Section for Head&Neck and Thoracic Oncology, Department of Oncology, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Claus Andrup', 'Initials': 'CA', 'LastName': 'Kristensen', 'Affiliation': 'Rigshospitalet, Section for Head&Neck and Thoracic Oncology, Department of Oncology, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Maria Herlestam Calero', 'Initials': 'MHC', 'LastName': 'Moreno', 'Affiliation': 'Theme Cancer, Medical Unit Head&Neck, Lung and Skin Cancer, Karolinska University Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Hedda Haugen', 'Initials': 'HH', 'LastName': 'Cange', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, 41345 Goteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Soderstrom', 'Affiliation': 'Department of Oncology, Norrlands University Hospital, 90185 Umea, Sweden.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Friesland', 'Affiliation': 'Theme Cancer, Medical Unit Head&Neck, Lung and Skin Cancer, Karolinska University Hospital, 17176 Stockholm, Sweden.'}]",Cancers,['10.3390/cancers12113110']
1881,33114392,Vitamin D Supplementation during Winter: Effects on Stress Resilience in a Randomized Control Trial.,"Vitamin D status may be important for stress resilience. This study investigated the effects of vitamin D supplements during winter on biological markers of stress resilience such as psychophysiological activity, serotonin, and cortisol in a placebo-controlled, randomized clinical trial. Eighty-six participants were randomly assigned to the Intervention (vitamin D) or Control (placebo) groups. Before and after the intervention participants were exposed to an experimental stress procedure. Psychophysiological activity was measured during three main conditions: baseline, stress, and recovery. Fasting blood samples were taken in the morning and saliva samples were collected at seven different time points across 24 h. Prior to intervention both groups had normal/sufficient vitamin D levels. Both groups showed a normal pattern of psychophysiological responses to the experimental stress procedure (i.e., increased psychophysiological responses from resting baseline to stress-condition, and decreased psychophysiological responses from stress-condition to recovery; all  p  < 0.009). Post-intervention, the Intervention group showed increased vitamin D levels ( p  < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p  < 0.001). Importantly, the Control group demonstrated a classic nadir in vitamin D status post-intervention (spring) ( p  < 0.001) and did not show normal psychophysiological responses. Thus, physiologically the Control group showed a sustained stress response. No significant effects of vitamin D were found on serotonin and cortisol.",2020,"Post-intervention, the Intervention group showed increased vitamin D levels ( p  < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p  < 0.001).",['Eighty-six participants'],"['vitamin D supplements', 'Intervention (vitamin D) or Control (placebo', 'Vitamin D Supplementation']","['normal psychophysiological responses', 'Psychophysiological activity', 'vitamin D', 'classic nadir in vitamin D status', 'sustained stress response', 'Fasting blood samples', 'serotonin and cortisol', 'normal pattern of psychophysiological responses', 'vitamin D levels', 'psychophysiological responses']","[{'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",86.0,0.0423443,"Post-intervention, the Intervention group showed increased vitamin D levels ( p  < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p  < 0.001).","[{'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Hansen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Christiesgt. 12, 5015 Bergen, Norway.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Ambroziak', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thornton', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Mundt', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Kahn', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, P.O. Box 1870, Nordnes, 5817 Bergen, Norway.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Waage', 'Affiliation': 'Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kattenbraker', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Araujo', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, P.O. Box 1870, Nordnes, 5817 Bergen, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murison', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Jonas Lies vei 91, 5021 Bergen, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Rypdal', 'Affiliation': 'Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Grung', 'Affiliation': 'Department of Chemistry, University of Bergen, Allégaten 41, 5007 Bergen, Norway.'}]",Nutrients,['10.3390/nu12113258']
1882,33114448,"Effects of Food Art Therapy on the Self-Esteem, Self-Expression, and Social Skills of Persons with Mental Illness in Community Rehabilitation Facilities.","Persons with mental illness often have low self-esteem, a lack of self-expression, and poor social skills. This study used a quasi-experimental two-group pre-test-post-test design to investigate the effects of food art therapy on the self-esteem, self-expression, and social skills of persons with mental illness attending community rehabilitation facilities. The authors recruited persons with mental illness aged 18 years or older attending three community rehabilitation facilities. Participants in two rehabilitation facilities participated in food art therapy (experimental groups 1 and 2;  n  = 15 for each group), and participants in the third rehabilitation facility participated in regular programs of the facility (control group,  n  = 30). Participants in the experimental groups attended a total of eight sessions of food art therapy twice per week for four weeks. The Korean versions of the Rosenberg self-esteem scale, self-expression scale, and social skill rating system were administered at pre- and post-test in both the experimental and control groups. The self-esteem, self-expression, and social skills of the experimental group improved significantly compared to the control group. The findings suggested that food art therapy would be an excellent psychosocial intervention to help persons with mental illness to rehabilitate in the community.",2020,"The self-esteem, self-expression, and social skills of the experimental group improved significantly compared to the control group.","['Participants in two rehabilitation facilities participated in food art therapy (experimental groups 1 and 2;  n  = 15 for each group), and participants in the third rehabilitation facility participated in regular programs of the facility (control group,  n  = 30', 'Persons with mental illness', 'persons with mental illness attending community rehabilitation facilities', 'Persons with Mental Illness in Community Rehabilitation Facilities', 'persons with mental illness aged 18 years or older attending three community rehabilitation facilities']","['Food Art Therapy', 'food art therapy']","['Self-Esteem, Self-Expression, and Social Skills', 'Rosenberg self-esteem scale, self-expression scale, and social skill rating system', 'self-esteem, self-expression, and social skills']","[{'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0565975', 'cui_str': 'Self-expression'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.0177515,"The self-esteem, self-expression, and social skills of the experimental group improved significantly compared to the control group.","[{'ForeName': 'Ju-Hye', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Chung-Ang University, Seoul 06974, Korea.'}, {'ForeName': 'Kwisoon', 'Initials': 'K', 'LastName': 'Choe', 'Affiliation': 'Department of Nursing, Chung-Ang University, Seoul 06974, Korea.'}, {'ForeName': 'Kyoungsook', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chung-Ang University, Seoul 06974, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040428']
1883,33114457,Development of a Family-Based Mental Health Program for Runaway Adolescents Using an Intervention Mapping Protocol.,"The mental health and related quality of life of runaway adolescents are global public health issues. As few intervention studies have considered the family contexts of runaway adolescents, we aimed to develop an intervention tailored specifically to the needs of this population using an Intervention Mapping protocol. First, a literature review and interviews with runaway adolescents and youth shelter workers were conducted to create a logic model of the problem. Second, the behavioral and environmental outcomes were set to adapt to stressful situations and enable families to become more resourceful in dealing with family adversity, based on the results of needs assessment. Performance objectives and changeable determinants were also created by reviewing the pertinent theories and studies. Third, theory- and evidence-based methods to influence changes in the determinants were identified. Fourth, we designed an eight-session family-based mental health program incorporating individual and family approaches for runaway adolescents. Fifth, we determined that mental health nurses at community mental health centers linked to youth shelters would serve as the program implementers. Finally, we planned a randomized controlled trial to evaluate the effects of our program on improving runaway adolescents' mental health status and perceived family functioning.",2020,"Finally, we planned a randomized controlled trial to evaluate the effects of our program on improving runaway adolescents' mental health status and perceived family functioning.","['Runaway Adolescents', 'runaway adolescents', 'for runaway adolescents', 'mental health nurses at community mental health centers linked to youth shelters', 'runaway adolescents and youth shelter workers']",['eight-session family-based mental health program incorporating individual and family approaches'],"[""runaway adolescents' mental health status and perceived family functioning""]","[{'cui': 'C0242660', 'cui_str': 'Runaways'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0242660', 'cui_str': 'Runaways'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}]",,0.0580799,"Finally, we planned a randomized controlled trial to evaluate the effects of our program on improving runaway adolescents' mental health status and perceived family functioning.","[{'ForeName': 'Dabok', 'Initials': 'D', 'LastName': 'Noh', 'Affiliation': 'College of Nursing, Eulji University, 553 Sanseong-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, 13135, Korea.'}, {'ForeName': 'Soobin', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Eulji University, 553 Sanseong-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, 13135, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17217794']
1884,33114566,Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula.,"PURPOSE


To compare the changes in visual and ocular parameters in individuals with retinal drusen who were treated with two commercially available nutritional supplements.
METHODS


An open-label, single-center, randomized, parallel-treatment with an observational control group design was utilized. The treatment groups included individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals. The treatment groups were randomly assigned to the micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV). Visual performance was evaluated using the techniques of visual acuity, dark adaptation recovery and contrast sensitivity, at baseline, three months, and six months. Additionally, the macular pigment optical density (MPOD) was measured. The control group was not assigned any carotenoid supplement. The right eye and left eye results were analyzed separately.
RESULTS


Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data. Of the individuals who completed this study, 25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group. The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p  < 0.001). The LM group displayed a positive linear trend with treatment time in CSF ( p  < 0.001), with benefits visible after just three months of supplementation. Although there was a trend showing improvement in CSF in the PV group, the change was not significant after a Bonferroni-corrected  p -value of  p  < 0.00625. Visual acuity, dark adaptation recovery and MPOD did not significantly improve in either treatment groups.
CONCLUSION


The LM group demonstrated greater and faster benefits in visual performance as measured by CSF when compared to the PV group. This trial has been registered at clinicaltrials.gov (NCT03946085).",2020,The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p  < 0.001).,"['individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals', '25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group', 'Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data', 'individuals with retinal drusen who were treated with two commercially available nutritional supplements', 'Eyes with Retinal Drusen']","['Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula', 'micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV', 'LM']","['visual acuity, dark adaptation recovery and contrast sensitivity', 'visual performance', 'Visual acuity, dark adaptation recovery and MPOD', 'macular pigment optical density (MPOD', 'contrast sensitivity function (CSF', 'CSF', 'Visual performance', 'Visual Function and Macular Carotenoid Changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2586580', 'cui_str': 'PreserVision'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",79.0,0.0697274,The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p  < 0.001).,"[{'ForeName': 'Pinakin Gunvant', 'Initials': 'PG', 'LastName': 'Davey', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Henderson', 'Affiliation': 'Eye Clinic of Austin, Austin, TX 78731, USA.'}, {'ForeName': 'Drake W', 'Initials': 'DW', 'LastName': 'Lem', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Weis', 'Affiliation': 'Eye Clinic of Austin, Austin, TX 78731, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Amonoo-Monney', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Evans', 'Affiliation': 'VectorVision/Guardion Health Sciences, San Diego, CA 92128, USA.'}]",Nutrients,['10.3390/nu12113271']
1885,33114585,The Anabolic Response to Dietary Protein Is Not Limited by the Maximal Stimulation of Protein Synthesis in Healthy Older Adults: A Randomized Crossover Trial.,"We have recently demonstrated in young adults that an anabolic response with mixed meal protein intake above ~35 g/meal, previously recognized as an ""optimal"" protein dose, was further stimulated. However, it is unknown if this applies to older adults. We therefore examined anabolic response to a mixed meal containing either 35 g (MOD, moderate amount of protein) or 70 g (HIGH, high amount of protein) in a randomized cross-over metabolic study in older adults ( n  = 8). Primed continuous infusions of L-[ 2 H 5 ] phenylalanine and L-[ 2 H 2 ]tyrosine were performed to determine whole-body protein kinetics and muscle protein fractional synthesis rate (MPS) in basal fasted and fed states. Whole-body protein kinetics (NB, net protein balance; PS, protein synthesis; PB, protein breakdown) and MPS was expressed as changes from the baseline post-absorptive state. Consistent with our previous findings in young adults, both feedings resulted in a positive NB, with HIGH being more positive than MOD. Furthermore, NB (expressed as g protein∙240 min) increased linearly with an increasing amount of protein intake, expressed relative to lean body mass. The positive NB was achieved due mainly to the suppression of PB in both MOD and to a greater extent HIGH, while PS was only increased in HIGH. Consistent with the whole-body data, MPS was significantly higher in HIGH than MOD. Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD. We conclude that in the context of mixed meals, whole-body anabolic response linearly increases with increasing protein intake primarily through the suppression of PB, and MPS was further stimulated with protein intake above the previously considered ""optimal"" protein dose in older adults.",2020,Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD.,"['young adults that an anabolic response with mixed meal protein intake above ~35', 'Healthy Older Adults', 'older adults', 'older adults ( n  = 8']","['L', 'phenylalanine and L', 'mixed meal containing either 35 g (MOD, moderate amount of protein) or 70 g (HIGH, high amount of protein']","['Plasma concentrations of essential amino acids and insulin', 'whole-body protein kinetics and muscle protein fractional synthesis rate (MPS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0139623,Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD.,"[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}, {'ForeName': 'Jiwoong', 'Initials': 'J', 'LastName': 'Jang', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}, {'ForeName': 'Myung Dong', 'Initials': 'MD', 'LastName': 'Choi', 'Affiliation': 'Department of Human Movement Science, Oakland University, Rochester, MI 48309, USA.'}, {'ForeName': 'Yun-A', 'Initials': 'YA', 'LastName': 'Shin', 'Affiliation': 'Department of Prescription & Rehabilitation of Exercise, Dankook University, Cheonan 31116, Korea.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Schutzler', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}]",Nutrients,['10.3390/nu12113276']
1886,33114649,Education or Provision? A Comparison of Two School-Based Fruit and Vegetable Nutrition Education Programs in the Netherlands.,"A healthy diet is important for optimal child growth and development. School-based opportunities to encourage children to achieve healthy eating behaviors should be explored. Nutrition education programs can provide school children with classroom-based nutrition education and access to fruits and vegetables (FV). However, the effectiveness of specific program components implemented separately has not yet been comprehensively evaluated. The current study examined effectiveness of individual components of two programs targeting primary school children ( n  = 1460,  n  = 37 schools) aged 7-12 years. Nutrition knowledge and FV consumption were measured using a student questionnaire, and presence of school food policies was measured in the teachers' questionnaire. A quasi-experimental design with three arms compared: (1) schools that implemented both programs: FV provision + education ( n  = 15), (2) schools that implemented the FV provision program only ( n  = 12), (3) schools that did not implement either program ( n  = 10). Outcomes were assessed pre-intervention (T0), during the intervention (T1), and 6 months post-intervention (T2). Results indicated a significant increase in nutrition knowledge for children attending schools that had participated in both programs, compared to control schools ( p  < 0.01), but no significant increase in FV intake. In schools without food policies, FV provision alone contributed to an increase in child FV intake ( p  < 0.05).",2020,"Results indicated a significant increase in nutrition knowledge for children attending schools that had participated in both programs, compared to control schools ( p  < 0.01), but no significant increase in FV intake.","['school children with classroom-based nutrition education and access to fruits and vegetables (FV', 'primary school children ( n  = 1460,  n  = 37 schools) aged 7-12 years']","['Two School-Based Fruit and Vegetable Nutrition Education Programs', 'Nutrition education programs', 'FV provision + education ( n  = 15), (2) schools that implemented the FV provision program only ( n  = 12), (3) schools that did not implement either program']","['nutrition knowledge', 'FV intake', 'Nutrition knowledge and FV consumption', 'child FV intake']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0108363,"Results indicated a significant increase in nutrition knowledge for children attending schools that had participated in both programs, compared to control schools ( p  < 0.01), but no significant increase in FV intake.","[{'ForeName': 'Angeliek', 'Initials': 'A', 'LastName': 'Verdonschot', 'Affiliation': 'Consumption and Healthy Lifestyles, Wageningen University and Research, 6700 EW Wageningen, The Netherlands.'}, {'ForeName': 'Emely', 'Initials': 'E', 'LastName': 'de Vet', 'Affiliation': 'Consumption and Healthy Lifestyles, Wageningen University and Research, 6700 EW Wageningen, The Netherlands.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'van Rossum', 'Affiliation': 'Consumption and Healthy Lifestyles, Wageningen University and Research, 6700 EW Wageningen, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Mesch', 'Affiliation': 'Consumption and Healthy Lifestyles, Wageningen University and Research, 6700 EW Wageningen, The Netherlands.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Center for Physical Activity and Nutrition (PRCPAN), The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bucher', 'Affiliation': 'Priority Research Center for Physical Activity and Nutrition (PRCPAN), The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Annemien', 'Initials': 'A', 'LastName': 'Haveman-Nies', 'Affiliation': 'Consumption and Healthy Lifestyles, Wageningen University and Research, 6700 EW Wageningen, The Netherlands.'}]",Nutrients,['10.3390/nu12113280']
1887,33115382,Encephaloduroarteriosynangiosis (EDAS) revascularization for symptomatic intracranial atherosclerotic steno-occlusive (ERSIAS) Phase-II objective performance criterion trial.,"BACKGROUND


Intracranial atherosclerotic disease (ICAD) is one of the most challenging stroke etiologies, with frequent recurrences despite optimized medical management. Encephaloduroarteriosynangiosis (EDAS) is an indirect revascularization method that produces extra-cranial collaterals to intracranial vessels. We present the results of a phase-II trial of EDAS in intracranial atherosclerotic disease patients.
AIMS


To evaluate the feasibility, safety, and preliminary efficacy of EDAS in intracranial atherosclerotic disease patients.
METHODS


ERSIAS was a prospective objective-performance-criterion trial of EDAS plus intensive medical management (IMM) in intracranial atherosclerotic disease (ICAD) patients failing medical treatment. Primary endpoint was any stroke/death within 30-days post-surgery or stroke in the territory of the qualifying artery beyond 30 days. The primary analysis compared event rates through one year with an objective-performance-criterion based on a 10% reduction from the 20% rate in the intensive medical management arm of the stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial (SAMMPRIS) in patients with poor collaterals. Event rates through two years were compared with propensity-score-matched (PSM) medically treated patients from SAMMPRIS and the carotid occlusion surgery study (COSS).
RESULTS


During a median follow-up of 24.5 months, 5 (9.6%) of 52 patients had a primary endpoint event. The primary endpoint rate at one year met the threshold for nonfutility and advancement to phase III (<10%). In the sensitivity analysis, primary endpoint event rate at two years was lower than in PSM controls, 9.6% versus 21.2% (p < 0.07). Overall, 86% of EDAS-plus-intensive medical management patients were functionally independent at last follow-up and 89% demonstrated neovascularization. There were two (3.8%) surgical complications and no intracranial hemorrhages.
CONCLUSION


ERSIAS phase II provides evidence of safety and strong signals of efficacy of EDAS-plus-intensive medical management, supporting advancement to a seamless phase-IIb/III trial.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov.NCT01819597.",2020,"In the sensitivity analysis, primary endpoint event rate at two years was lower than in PSM controls, 9.6% versus 21.2% (p < 0.07).","['intracranial atherosclerotic disease (ICAD) patients failing medical treatment', 'intracranial atherosclerotic disease patients', 'symptomatic intracranial atherosclerotic steno-occlusive (ERSIAS', 'patients with poor collaterals']","['EDAS plus intensive medical management (IMM', 'Encephaloduroarteriosynangiosis (EDAS) revascularization', 'Encephaloduroarteriosynangiosis (EDAS', 'EDAS']","['surgical complications and no intracranial hemorrhages', 'stroke/death within 30-days post-surgery or stroke in the territory of the qualifying artery beyond 30 days', 'primary endpoint rate at one year met the threshold for nonfutility and advancement to phase III', 'neovascularization']","[{'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0524571', 'cui_str': 'Steno bredanensis'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}]","[{'cui': 'C1504429', 'cui_str': 'Encephalo-duro-arterio-synangiosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}]",,0.0658465,"In the sensitivity analysis, primary endpoint event rate at two years was lower than in PSM controls, 9.6% versus 21.2% (p < 0.07).","[{'ForeName': 'Nestor R', 'Initials': 'NR', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lyden', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shlee', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schlick', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Dumitrascu', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Miguel D', 'Initials': 'MD', 'LastName': 'Quintero-Consuegra', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Toscano', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Restrepo', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hinman', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Alexander', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Schievink', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Piantadosi', 'Affiliation': 'Department of Neurology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020967256']
1888,33115408,Comparison of the impact of propofol versus sevoflurane on early postoperative recovery in living donors after laparoscopic donor nephrectomy: a prospective randomized controlled study.,"BACKGROUND


Enhancing postoperative recovery of the donor is important to encourage living kidney donation. We investigated the effects of anesthetic agents (intravenous [IV] propofol versus inhaled [IH] sevoflurane) on the quality of early recovery of healthy living kidney donors after hand-assisted laparoscopic nephrectomy (HALN) under analgesic intrathecal morphine injection.
METHODS


This single-center, prospective randomized controlled study enrolled 80 living donors undergoing HALN from October 2019 to June 2020 at Seoul St. Mary's Hospital. Donors were randomly assigned to the IV propofol group or IH sevoflurane group. To measure the quality of recovery, we used the Korean version of the Quality of Recovery-40 questionnaire (QoR-40 K) on postoperative day (POD) 1, and ambulation (success rate, number of footsteps) 6-12 h after surgery and on POD 1. The pain score for the wound site, IV opioid requirement, postoperative complications including incidences of nausea/vomiting, and length of in-hospital stay were also assessed.
RESULTS


The global QoR-40 K score and all subscale scores (physical comfort, emotional state, physical independence, psychological support, and pain) were significantly higher in the IV propofol group than in the IH sevoflurane group. The numbers of footsteps at all time points were also higher in the IV propofol group. Donors in the IV propofol group had a lower incidence of nausea/vomiting, and a shorter hospitalization period.
CONCLUSIONS


Total IV anesthesia with propofol led to better early postoperative recovery than that associated with IH sevoflurane.
TRIAL REGISTRATION


Clinical Research Information Service, Republic of Korea (approval number: KCT0004351 ) on October 18, 2019.",2020,"Donors in the IV propofol group had a lower incidence of nausea/vomiting, and a shorter hospitalization period.
","['living donors after laparoscopic donor nephrectomy', 'healthy living kidney donors after hand-assisted laparoscopic nephrectomy (HALN) under analgesic intrathecal morphine injection', ""80 living donors undergoing HALN from October 2019 to June 2020 at Seoul St. Mary's Hospital""]","['propofol group or IH sevoflurane', 'IH sevoflurane', 'propofol', 'anesthetic agents (intravenous [IV] propofol versus inhaled [IH] sevoflurane', 'propofol versus sevoflurane']","['nausea/vomiting, and length of in-hospital stay', 'numbers of footsteps', 'global QoR-40\u2009K score and all subscale scores (physical comfort, emotional state, physical independence, psychological support, and pain', 'Korean version of the Quality of Recovery-40 questionnaire (QoR-40\u2009K) on postoperative day (POD) 1, and ambulation (success rate, number of footsteps', 'nausea/vomiting', 'pain score', 'early postoperative recovery']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C4305252', 'cui_str': 'Live donor of kidney'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C4074518', 'cui_str': 'Morphine Injection [Infumorph]'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0303276', 'cui_str': 'Potassium-40'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",80.0,0.0881181,"Donors in the IV propofol group had a lower incidence of nausea/vomiting, and a shorter hospitalization period.
","[{'ForeName': 'Sangbin', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Emergency medicine, Cheongyang Health Center County Hospital, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Jaesik', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ""Department of anesthesiology and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea.""}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': ""Department of anesthesiology and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea.""}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': ""Department of anesthesiology and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea.""}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Chae', 'Affiliation': ""Department of anesthesiology and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea. shscms@gmail.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01190-9']
1889,33115428,Primary care and mental health providers' perceptions of implementation of pharmacogenetics testing for depression prescribing.,"BACKGROUND


Pharmacogenetic testing (PGx) has the potential to improve the quality of psychiatric prescribing by considering patients' genetic profile. However, there is limited scientific evidence supporting its efficacy or guiding its implementation. The Precision Medicine in Mental Health (PRIME) Care study is a pragmatic randomized controlled trial evaluating the effectiveness of a specific commercially-available pharmacogenetic (PGx) test to inform antidepressant prescribing at 22 sites across the U.S. Simultaneous implementation science methods using the Consolidated Framework for Implementation Research (CFIR) are integrated throughout the trial to identify contextual factors likely to be important in future implementation of PGx. The goal of this study was to understand providers' perceptions of PGx for antidepressant prescribing and implications for future implementation.
METHODS


Qualitative focus groups (n = 10) were conducted at the beginning of the trial with Primary Care and Mental Health providers (n = 31) from six PRIME Care sites. Focus groups were audio-recorded and transcribed and data were analyzed using rapid analytic procedures organized by CFIR domains.
RESULTS


Analysis revealed themes in the CFIR Intervention Characteristics domain constructs of Evidence, Relative Advantage, Adaptability, Trialability, Complexity, and Design that are important for understanding providers' perceptions of PGx testing. Results indicate: 1) providers had limited experience and knowledge of PGx testing and its evidence base, particularly for psychiatric medications; 2) providers were hopeful that PGx could increase their precision in depression prescribing and improve patient engagement, but were uncertain about how results would influence treatment; 3) providers were concerned about potential misinterpretation of PGx results and how to incorporate testing into their workflow; 4) primary care providers were less familiar and comfortable with application of PGx testing to antidepressant prescribing than psychiatric providers.
CONCLUSIONS


Provider perceptions may serve as facilitators or barriers to implementation of PGx for psychiatric prescribing. Incorporating implementation science into the conduct of the RCT adds value by uncovering factors to be addressed in preparing for future implementation, should the practice prove effective.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03170362 ; Registered 31 May 2017.",2020,The Precision Medicine in Mental Health (PRIME) Care study is a pragmatic randomized controlled trial evaluating the effectiveness of a specific commercially-available pharmacogenetic (PGx) test to inform antidepressant prescribing at 22 sites across the U.S. Simultaneous implementation science methods using the Consolidated Framework for Implementation Research (CFIR) are integrated throughout the trial to identify contextual factors likely to be important in future implementation of PGx.,['Qualitative focus groups (n\u2009=\u200910) were conducted at the beginning of the trial with Primary Care and Mental Health providers (n\u2009=\u200931) from six PRIME Care sites'],['specific commercially-available pharmacogenetic (PGx'],"['CFIR Intervention Characteristics domain constructs of Evidence, Relative Advantage, Adaptability, Trialability, Complexity, and Design']","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2718059', 'cui_str': 'P Health'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}]","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]",,0.0726688,The Precision Medicine in Mental Health (PRIME) Care study is a pragmatic randomized controlled trial evaluating the effectiveness of a specific commercially-available pharmacogenetic (PGx) test to inform antidepressant prescribing at 22 sites across the U.S. Simultaneous implementation science methods using the Consolidated Framework for Implementation Research (CFIR) are integrated throughout the trial to identify contextual factors likely to be important in future implementation of PGx.,"[{'ForeName': 'Bonnie M', 'Initials': 'BM', 'LastName': 'Vest', 'Affiliation': 'Department of Family Medicine, State University of New York- University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA. bvest@buffalo.edu.'}, {'ForeName': 'Laura O', 'Initials': 'LO', 'LastName': 'Wray', 'Affiliation': 'Department of Family Medicine, State University of New York- University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Brady', 'Affiliation': 'Department of Family Medicine, State University of New York- University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'VISN 4 Mental Illness, Research, Education and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Beehler', 'Affiliation': 'VA Center for Integrated Healthcare, VA Western New York Healthcare System, Buffalo, NY, USA.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Chapman', 'Affiliation': 'VISN 4 Mental Illness, Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Leland E', 'Initials': 'LE', 'LastName': 'Hull', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'VISN 4 Mental Illness, Research, Education and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}]",BMC psychiatry,['10.1186/s12888-020-02919-z']
1890,33115436,"High-sensitivity Troponin T in hemodialysis patients: a randomized placebo-controlled sub-study investigating angiotensin-II-blockade, variation over time and associations with clinical outcome.","BACKGROUND


Troponin T (TnT) is a well-known risk factor for negative outcome in hemodialysis (HD) patients, but little is known about variation over time, and the impact of clinical and dialysis specific factors. This study investigated the effect of angiotensin II receptor blockade (ARB), short and long-term variation in TnT and associations with clinical parameters.
METHODS


In this analysis based on the SAFIR-cohort (Clinical Trials ID: NCT00791830) 81 HD patients were randomized double-blind for placebo (n = 40) or angiotensin II receptor blocker (ARB) treatment (n = 41) with irbesartan (150-300 mg) and followed for 12 months with six serial measurements of TnT using a high-sensitivity assay.
RESULTS


Fifty-four patients (67%) completed follow-up. Baseline TnT-medians (min-max) were (placebo/ARB): 45(14-295)/46(10-343) ng/L. ARB-treatment did not significantly affect mean TnT-levels over the 12-month study period. Median week-to-week and one-year TnT-variation (5th-95th-percentile range) using all samples regardless of intervention were: 0(- 14-10) ng/L (week-to-week) and 3(- 40-71) ng/L (12 months). Median TnT-amplitude, capturing the change from the lowest to the highest TnT-value observed during the one-year study period was 38% or 20.5 ng/L. Median ratios with 95% limits of agreement were: 1.00(0.73-1.37); P = 0.92 (1 week/baseline; n = 77) and 1.07(0.52-2.25); P = 0.19 (12 months/baseline; n = 54). Baseline TnT was positively correlated with diabetes, ultrafiltration volume, arterial stiffness, change in intradialytic total peripheral resistance and N-terminal pro b-type natriuretic peptide (NT-proBNP) and negatively correlated with hematocrit, residual renal function and change in intradialytic cardiac output. High baseline TnT was associated with a higher risk of admission and cardiovascular (CV) events during follow-up. Increase in TnT over time (ΔTnT = 12-months-baseline) was significantly associated with increase in left ventricular (LV) mass and NT-proBNP and decrease in LV ejection fraction and late intradialytic stroke volume. ΔTnT was not significantly associated with admissions, CV or intradialytic hypotensive events during follow-up. Admissions were significantly more likely with a high (TnT-amplitude> 20.5 ng/L) than a low TnT-amplitude. Peaks in TnT were less frequent in aspirin-treated patients.
CONCLUSION


ARB-treatment had no significant effect on TnT-levels. Week-to-week variation was generally low, yet over 12 months individual patients had considerable TnT fluctuations. Rise in TnT over time was significantly correlated with markers of cardiac deterioration.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT00791830 . Date of registration: November 17, 2008. EudraCT no: 2008-001267-11.",2020,Admissions were significantly more likely with a high (TnT-amplitude> 20.5 ng/L) than a low TnT-amplitude.,"['81 HD patients', 'hemodialysis patients', 'hemodialysis (HD) patients']","['placebo/ARB', 'angiotensin II receptor blocker (ARB) treatment (n\u2009=\u200941) with irbesartan', 'High-sensitivity Troponin T', 'placebo', 'Troponin T (TnT', 'angiotensin II receptor blockade (ARB', 'EudraCT']","['higher risk of admission and cardiovascular (CV) events', 'left ventricular (LV) mass and NT-proBNP and decrease in LV ejection fraction and late intradialytic stroke volume', 'mean TnT-levels', 'admissions, CV or intradialytic hypotensive events', 'hematocrit, residual renal function and change in intradialytic cardiac output', 'diabetes, ultrafiltration volume, arterial stiffness, change in intradialytic total peripheral resistance and N-terminal pro b-type natriuretic peptide (NT-proBNP', 'Median TnT-amplitude']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0003011', 'cui_str': 'Angiotensin II Receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",81.0,0.328878,Admissions were significantly more likely with a high (TnT-amplitude> 20.5 ng/L) than a low TnT-amplitude.,"[{'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Peters', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. cdp@clin.au.dk.'}, {'ForeName': 'Krista D', 'Initials': 'KD', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Kent L', 'Initials': 'KL', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bo M', 'Initials': 'BM', 'LastName': 'Bibby', 'Affiliation': 'Department of Biostatistics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Jespersen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}]",BMC nephrology,['10.1186/s12882-020-02103-1']
1891,33115487,Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study.,"BACKGROUND


The past decade has seen the emergence of rehabilitation treatments using virtual reality. One of the advantages in using this technology is the potential to create positive motivation, by means of engaging environments and tasks shaped in the form of serious games. The aim of this study is to determine the efficacy of immersive Virtual Environments and weaRable hAptic devices (VERA) for rehabilitation of upper limb in children with Cerebral Palsy (CP) and Developmental Dyspraxia (DD).
METHODS


A two period cross-over design was adopted for determining the differences between the proposed therapy and a conventional treatment. Eight children were randomized into two groups: one group received the VERA treatment in the first period and the manual therapy in the second period, and viceversa for the other group. Children were assessed at the beginning and the end of each period through both the Nine Hole Peg Test (9-HPT, primary outcome) and Kinesiological Measurements obtained during the performing of similar tasks in a real setting scenario (secondary outcomes).
RESULTS


All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness). No statistically significant differences have been found between the two groups.
CONCLUSIONS


These findings suggest that immersive VE and wearable haptic devices is a viable alternative to conventional therapy for improving upper extremity function in children with neuromotor impairments. Trial registration ClinicalTrials, NCT03353623. Registered 27 November 2017-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03353623.",2020,"All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness).","['children with Cerebral Palsy (CP) and Developmental Dyspraxia (DD', 'children with neuromotor impairments', 'Eight children']","['immersive Virtual Environments and weaRable hAptic devices (VERA', 'VERA', 'immersive VE and wearable haptic devices', 'Immersive Virtual Environments and Wearable Haptic Devices']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],8.0,0.052256,"All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness).","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bortone', 'Affiliation': 'Institute of Clinical Physiology (IFC), National Research Council (CNR), Pisa, Italy. ilariabortone@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Barsotti', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Leonardis', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Crecchi', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tozzini', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonfiglio', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frisoli', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00771-6']
1892,33115598,"The effect of dietary nitrate and vitamin C on endothelial function, oxidative stress and blood lipids in untreated hypercholesterolemic subjects: A randomized double-blind crossover study.","BACKGROUND


Vitamin C may enhance nitric oxide (NO) production through stepwise reduction of dietary nitrate (NO 3 ) to nitrite (NO 2 ) to NO. The combined effect of vitamin C and NO 3  supplementation is relatively unexplored in untreated hypercholesterolemia.
AIMS


We aimed to examine whether co-administration of vitamin C and nitrate for 4-weeks would improve endothelial function (primary outcome), plasma NO metabolites, oxidative stress, and blood lipids (secondary outcomes).
METHODS


Subjects 50-70 years of age with low density lipoprotein (LDL) > 130 mg/dL and RHI ≤2 were enrolled in this randomized double-blind crossover study. Subjects were assigned to two 4-week supplementation treatments starting with 70 ml of concentrated beetroot juice (CBJ) with 1000 mg of vitamin C (NC) or CBJ with matched placebo (N), then switched to alternate treatment following 2-week washout. The change in reactive hyperemia index (RHI), sum of plasma NO metabolites (NO 2  + NO 3  (NOx)), oxidized LDL (oxLDL), and serum lipids were assessed at baseline and at 4-weeks of each treatment period.
RESULTS


Eighteen subjects (11M:7F) completed all study visits. No significant treatment differences were observed in RHI change (N: 0.21 ± 0.12; NC: 0.20 ± 0.17; p = 0.99). Secondary analysis revealed that a subgroup of NC subjects who started with a baseline RHI of <1.67 (threshold value for ED) had greater improvements in RHI compared to subjects with RHI >1.67 (1.23 ± 0.15 to 1.96 ± 0.19; n = 8 vs. 1.75 ± 0.11 to 1.43 ± 0.10; n = 8; p = 0.02). Compared to N, NC experienced a significant increase in plasma NOx (N: 94.2 ± 15.5 μmol/L; NC: 128.7 ± 29.1 μmol/L; p = 0.01). Although there was no significant difference in oxLDL change between treatments (N: -1.08 ± 9.8 U/L; NC: -6.07 ± 9.14 U/L; p = 0.19), NC elicited significant reductions in LDL (N: 2.2 ± 2; NC: -10.7 ± 23; p = 0.049), triglycerides (N: 14.6 ± 43; NC: -43.7 ± 45; p = 0.03), and no change in serum high density lipoprotein. Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01).
CONCLUSIONS


No between intervention differences were observed in RHI. RHI only improved in NC subjects with ED at intervention baseline. Four weeks of NC enriched the NO pool and promoted reduction of blood lipids and oxidative stress in subjects with hypercholesterolemia. These preliminary findings highlight a supplementation strategy that may reduce the progression of atherosclerotic disease and deserves further attention in studies using flow mediated dilation methods.
CLINICAL TRIAL REGISTRATION


www.clinicaltrials.gov (NCT04283630).",2020,"Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01).
","['Subjects 50-70 years of age with low density lipoprotein (LDL)\xa0', '130', 'untreated hypercholesterolemic subjects', 'subjects with hypercholesterolemia', 'Eighteen subjects (11M:7F) completed all study visits']","['vitamin C and NO 3  supplementation', 'vitamin C and nitrate', 'supplementation treatments starting with 70\xa0ml of concentrated beetroot juice (CBJ) with 1000\xa0mg of vitamin C (NC) or CBJ with matched placebo', 'dietary nitrate and vitamin C']","['NO 3  (NOx)), oxidized LDL (oxLDL), and serum lipids', 'endothelial function (primary outcome), plasma NO metabolites, oxidative stress, and blood lipids (secondary outcomes', 'reactive hyperemia index (RHI), sum of plasma', 'plasma NOx', 'RHI', 'RHI change', 'oxLDL change', 'endothelial function, oxidative stress and blood lipids', 'serum high density lipoprotein', 'blood lipids and oxidative stress', 'NC reduced oxLDL']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.517327,"Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01).
","[{'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Basaqr', 'Affiliation': 'Department of Pharmacology and Nutritional Sciences, College of Medicine, University of Kentucky, USA. Electronic address: reem.basaqr@uky.edu.'}, {'ForeName': 'Michealia', 'Initials': 'M', 'LastName': 'Skleres', 'Affiliation': 'Department of Pharmacology and Nutritional Sciences, College of Medicine, University of Kentucky, USA. Electronic address: michealia.skleres@uky.edu.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Jayswal', 'Affiliation': 'Department of Biostatistics & Bioinformatics, University of Kentucky, USA. Electronic address: rani.jayswal@uky.edu.'}, {'ForeName': 'D Travis', 'Initials': 'DT', 'LastName': 'Thomas', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition, College of Health Sciences, University of Kentucky, USA. Electronic address: dth225@uky.edu.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.012']
1893,33115615,Gravity and Mastoid effusion.,"BACKGROUND


Asymptomatic mastoid effusions have recently been observed in astronauts returning from long-term spaceflight. In hospitalized patients, mastoid effusion increases the risk for bacterial otitis/mastoiditis. We reasoned that cephalad fluid shifts during strict -6° head down tilt bed-rest (HDT) could reproduce space-flight associated mastoid effusion and that artificial gravity may reverse the response.
METHODS


The recent ""Artificial Gravity Bed-Rest Study"" (AGBRESA) tested influences of artificial gravity (AG) during 60 days head down bed rest on a short-arm human centrifuge in healthy subjects. The two intervention groups received daily AG with 30 minutes continuous AG (cAG) or Intermittend AG. A third group acted as a control group with no AG. We assessed cranial magnetic resonance images (MRI) for mastoid effusions one day before HDT, at day 14 and 52 of HDT, and three days after HDT.
RESULTS


Among twelve subjects in the first study campaign, none exhibited mastoid effusions before HDT. Five subjects showed mastoid effusions at HDT day 14 (3 cAG, 1 iAG, 1 control). Eleven subjects showed mastoid effusions at HDT day 52 and three days after HDT (3 cAG, 4 iAG, 4 control).
CONCLUSIONS


Mastoid effusions commonly occur during strict HDT bed-rest. The model can be applied to study the mechanisms and potential countermeasures for space flight-associated mastoid effusions and to test potential countermeasures. Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.",2020,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,['healthy subjects'],"['strict -6° head down tilt bed-rest (HDT', 'daily AG with 30 minutes continuous AG (cAG) or Intermittend AG', 'control group with no AG']","['Gravity and Mastoid effusion', 'Formation of mastoid effusions', 'mastoid effusions', 'cranial magnetic resonance images (MRI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C2609130', 'cui_str': 'Mastoid effusion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",,0.0531499,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,"[{'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Lecheler', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany. Electronic address: leopold.lecheler@dlr.de.'}, {'ForeName': 'Freia', 'Initials': 'F', 'LastName': 'Paulke', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sonnow', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Limper', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany; Department of Anesthesiology and Intensive Care Medicine, Merheim Medical Center, Hospitals of Cologne, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schwarz', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Jansen', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Cologne, Germany.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Klussmann', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.09.020']
1894,33115675,"Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An Exploratory Randomized, Controlled Trial.","BACKGROUND


Effective antiviral drugs for COVID-19 are still lacking. This study aims to evaluate the clinical outcomes and plasma concentrations of baloxavir acid and favipiravir in COVID-19 patients.
METHODS


Favipiravir and baloxavir acid were evaluated for their antiviral activity against SARS-CoV-2 in vitro before the trial initiation. We conducted an exploratory trial with 3 arms involving hospitalized adult patients with COVID-19. Patients were randomized assigned in a 1:1:1 ratio into baloxavir marboxil group, favipiravir group, and control group. The primary outcome was the percentage of subjects with viral negative by Day 14 and the time from randomization to clinical improvement. Virus load reduction, blood drug concentration and clinical presentation were also observed. The trial was registered with Chinese Clinical Trial Registry (ChiCTR 2000029544).
RESULTS


Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled. The percentage of patients who turned viral negative after 14-day treatment was 70%, 77%, and 100% in the baloxavir marboxil, favipiravir, and control group respectively, with the medians of time from randomization to clinical improvement was 14, 14 and 15 days, respectively. One reason for the lack of virological effect and clinical benefits may be due to insufficient concentrations of these drugs relative to their antiviral activities. One of the limitations of this study is the time from symptom onset to randomization, especially in the baloxavir marboxil and control groups, which is higher than the favipiravir group.
CONCLUSIONS


Our findings could not prove a benefit of addition of either baloxavir marboxil or favipiravir under the trial dosages to the existing standard treatment.",2020,"RESULTS


Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled.","['hospitalized adult patients with COVID-19', 'COVID-19 Patients', 'COVID-19 patients', '100 μM. Thirty patients were enrolled']","['baloxavir marboxil group, favipiravir group, and control group']","['antiviral activity', 'percentage of patients who turned viral negative', 'Virus load reduction, blood drug concentration and clinical presentation', 'Plasma Concentrations of Baloxavir Marboxil and Favipiravir', 'percentage of subjects with viral negative']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018938', 'cui_str': 'Hematologic agent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]",,0.102533,"RESULTS


Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Hangping', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xingjiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Kaijin', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Lingjuan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Tingbo', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Yunqing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China. Electronic address: qiuyq@zju.edu.cn.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105631']
1895,33115727,Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial.,"OBJECTIVE


Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).
DESIGN


Eligible patients (body mass index 30-40 kg/m 2 ) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.
RESULTS


Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.
CONCLUSIONS


This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.
TRIAL REGISTRATION NUMBER


NCT03255005.",2020,", mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001).","['Eligible patients (body mass index 30-40 kg/m 2 ', 'moderately obese patients', '71 patients included (five male, mean age 40 years']","['E-ESG', 'lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical', 'new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium', 'Endoscopic sutured gastroplasty', 'Endoscopic suture gastroplasty (ESG']","['weight loss', 'satiety tests', 'total body weight loss', 'No procedure-related or device-related severe adverse events', 'QoL', 'mean volume', 'mean excess weight loss (EWL', 'mean quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332126', 'cui_str': 'No treatment required for'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",71.0,0.11849,", mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001).","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Huberty', 'Affiliation': 'Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium Vincent.Huberty@erasme.ulb.ac.be.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Boskoski', 'Affiliation': 'Digestive Endoscopy Unit, Digestive Endoscopy Unit. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Bove', 'Affiliation': 'Digestive Endoscopy Unit, Digestive Endoscopy Unit. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Van Ouytsel', 'Affiliation': 'Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Costamagna', 'Affiliation': 'Digestive Endoscopy Unit, Digestive Endoscopy Unit. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Barthet', 'Affiliation': 'Gastroenterology, Hopital Nord, Marseille, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Devière', 'Affiliation': 'Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium.'}]",Gut,['10.1136/gutjnl-2020-322026']
1896,33115760,Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme.,"OBJECTIVES


This integrated analysis presents the safety profile of upadacitinib, a Janus kinase inhibitor, at 15 mg and 30 mg once daily in patients with moderately to severely active rheumatoid arthritis (RA).
METHODS


Treatment-emergent adverse events (TEAEs) and laboratory data from five randomised, placebo- or active-controlled phase III trials of upadacitinib for patients with RA were analysed and summarised. Exposure-adjusted event rates are shown for placebo (three trials; 12/14 weeks), methotrexate (two trials; mean exposure: 36 weeks), adalimumab (one trial; mean exposure: 42 weeks), upadacitinib 15 mg (five trials; mean exposure: 53 weeks) and upadacitinib 30 mg (four trials; mean exposure: 59 weeks).
RESULTS


3834 patients received one or more doses of upadacitinib 15 mg (n=2630) or 30 mg (n=1204), for a total of 4020.1 patient-years of exposure. Upper respiratory tract infection, nasopharyngitis and urinary tract infection were the most commonly reported TEAEs with upadacitinib. Rates of serious infection were similar between upadacitinib 15 mg and adalimumab but higher compared with methotrexate. Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg. Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) were similar across treatment groups.
CONCLUSION


In the phase III clinical programme for RA, patients receiving upadacitinib had an increased risk of herpes zoster and CPK elevation versus adalimumab. Rates of malignancies, MACEs and VTEs were similar among patients receiving upadacitinib, methotrexate or adalimumab.
TRIAL REGISTRATION NUMBERS


SELECT-EARLY: NCT02706873; SELECT-NEXT: NCT02675426; SELECT-COMPARE: NCT02629159; SELECT-MONOTHERAPY: NCT02706951; SELECT-BEYOND: NCT02706847.",2020,"Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg.","['rheumatoid arthritis', '3834 patients', 'patients with moderately to severely active rheumatoid arthritis (RA']","['methotrexate and adalimumab', 'methotrexate', 'methotrexate or adalimumab', 'upadacitinib', 'placebo', 'adalimumab']","['rates of gastrointestinal perforations', 'risk of herpes zoster and CPK elevation', 'Rates of malignancies, MACEs and VTEs', 'Rates of serious infection', 'Upper respiratory tract infection, nasopharyngitis and urinary tract infection', 'Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs', 'Rates of herpes zoster and creatine phosphokinase (CPK) elevations']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0151664', 'cui_str': 'Gastrointestinal perforation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3834.0,0.236005,"Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg.","[{'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, Texas, USA arthdoc@aol.com.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Universitario Central Paulista, São Paulo, Brazil.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hendrickson', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218510']
1897,33115783,"Diet-associated inflammation modulates inflammation and WNT signaling in the rectal mucosa, and the response to supplementation with dietary fibre.","Inflammation drives colorectal cancer (CRC) development and CRC risk is influenced by dietary factors, including dietary fibre. Hyperactive WNT signalling occurs in CRC and may regulate inflammation. This study investigated i) relationships between the inflammatory potential of diet, assessed using the Energy-adjusted Dietary Inflammatory Index (E-DIITM), and markers of WNT signalling, and ii) whether DII status modulated the response to supplementation with two types of dietary fibre. Seventy-five healthy participants were supplemented with resistant starch (RS) and/or polydextrose (PD) or placebo for 50 days. Rectal biopsies were collected pre and post-intervention and used to assess WNT pathway gene expression and crypt cell proliferation. E-DII scores were calculated from food frequency questionnaire data. High-sensitivity C-reactive protein (hsCRP) and faecal calprotectin concentrations were quantified. hsCRP concentration was significantly greater in participants with higher E-DII scores (least square means (LSM) 4.7 vs. 2.4mg/L, P=0.03). Baseline E-DII score correlated with FOSL1 (β= 0.503, P=0.003) and WNT11 (β=0.472, P=0.006) expression, after adjusting for age, gender, BMI, endoscopy procedure and smoking status. WNT11 expression was more than two-fold greater in individuals with higher E-DII scores (LSM 0.131 vs. 0.059, P=0.002). Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04). More pro-inflammatory diets were associated with altered WNT signalling and appeared to modulate the effects of PD supplementation on expression of FOSL1. This is the first study to investigate relationships between the E-DII and molecular markers of WNT signalling in rectal tissue of healthy individuals.",2020,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"['Seventy-five healthy participants', 'rectal tissue of healthy individuals']","['PD supplementation', 'resistant starch (RS) and/or polydextrose (PD) or placebo']","['WNT11 expression', 'hsCRP concentration', 'High-sensitivity C-reactive protein (hsCRP) and faecal calprotectin concentrations', 'E-DII scores', 'Baseline E-DII score', 'FOSL1 expression']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1442821', 'cui_str': 'FOSL1 protein, human'}]",75.0,0.0442883,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Epidemiology and Biostatistics, University of South Carolina.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Epidemiology and Biostatistics, University of South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Epidemiology and Biostatistics, Connecting Health Innovations LLC.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Kocaadam-Bozkurt', 'Affiliation': 'Nutrition and Dietetics, Gazi University.'}, {'ForeName': 'Aycil', 'Initials': 'A', 'LastName': 'Özturan-Sirin', 'Affiliation': 'Adnan Menderes University.'}, {'ForeName': 'Seamus B', 'Initials': 'SB', 'LastName': 'Kelly', 'Affiliation': 'North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Surgery, Wansbeck Hospital.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'School of Environmental Sciences, University of East Anglia.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Food and Health, Quadram Institute.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, University of Newcastle john.mathers@ncl.ac.uk.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0335']
1898,33115831,Effect of the Carer Support Needs Assessment Tool intervention (CSNAT-I) in the Danish specialised palliative care setting: a stepped-wedge cluster randomised controlled trial.,"BACKGROUND


The Carer Support Needs Assessment Tool intervention (CSNAT-I) has been shown to improve end-of-life care support for informal caregivers. This study investigated the impact of the CSNAT-I on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark.
METHODS


A stepped-wedge cluster randomised controlled trial with nine clusters (ie, SPC teams). Outcome measures were collected using caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up.
RESULTS


A total of 437 caregivers were enrolled (control group, n=255; intervention group, n=182). No intervention effect was found on the primary outcome, caregiver strain at T1 (p=0.1865). However, positive effects were found at T1 and T2 on attention to caregivers' well-being (p<0.0001), quality of information and communication (p<0.0001), amount of information (T1: p=0.0002; T2: p<0.0001), involvement (T1: p=0.0045; T2: p<0.0001), talking about greatest burdens (p<0.0001) and assistance in managing greatest burdens (p<0.0001). The effect sizes of these differences were medium or large and seemed to increase from T1 to T2. At T1, positive effects were found on distress (p=0.0178) and home care responsibility (p=0.0024). No effect was found on the remaining outcomes.
CONCLUSION


Although no effect was found on caregiver strain, the CSNAT-I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
TRIAL REGISTRATION NUMBER


NCT03466580.",2020,"I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
","['on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark', '437 caregivers were enrolled (control group, n=255; intervention group, n=182']","['Carer Support Needs Assessment Tool intervention (CSNAT-I', 'CSNAT-I']","['caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up', 'quality of information and communication (p<0.0001), amount of information (T1', 'distress (p=0.0178) and home care responsibility', 'caregiver strain, the CSNAT', ""caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4075872', 'cui_str': 'Carer Support Needs Assessment Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",437.0,0.218476,"I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark line.lund.01@regionh.dk.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annemette', 'Initials': 'A', 'LastName': 'Blach', 'Affiliation': 'Hospice Soendergaard, Maaloev, Denmark.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rosted', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Bollig', 'Affiliation': 'Palliative Care Team, Medical Department Soenderborg/Toender, South Jutland Hospital, Soenderborg, Denmark.'}, {'ForeName': 'Gitte Irene', 'Initials': 'GI', 'LastName': 'Juhl', 'Affiliation': 'Palliative Care Unit, Department of Oncology and Palliative Care, North Zealand Hospital, Frederikssund, Denmark.'}, {'ForeName': 'Hanne Bollerup', 'Initials': 'HB', 'LastName': 'Farholt', 'Affiliation': 'Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Winther', 'Affiliation': 'Palliative Care Unit, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Laursen', 'Affiliation': 'Department of Palliative Care, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hasse', 'Affiliation': 'Diakonissestiftelsens Hospice, Frederiksberg, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Weensgaard', 'Affiliation': 'Arresoedal Hospice, Frederiksvaerk, Denmark.'}, {'ForeName': 'Mai-Britt', 'Initials': 'MB', 'LastName': 'Guldin', 'Affiliation': 'Palliative Care Team, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ewing', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Grande', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002467']
1899,33115893,"""I'm in a very good frame of mind"": a qualitative exploration of the experience of standing frame use in people with progressive multiple sclerosis.","OBJECTIVES


The study aim was to explore the experiences of people with progressive multiple sclerosis (MS) and their standing assistants during their participation in Standing Up in Multiple Sclerosis, a randomised controlled trial (RCT) of a home-based, self-managed standing frame programme.
DESIGN


A qualitative approach, using audio diary methodology was used to collect data contemporaneously. Diary data were transcribed verbatim and analysed using thematic analysis.
SETTING


Participants were recruited from eight healthcare organisations in two regions of the UK. The intervention was home-based.
PARTICIPANTS


As part of the RCT, 140 participants were randomly allocated to either usual care or usual care plus a standing frame programme. Using a sampling matrix 12 people with progressive MS (6 female, aged 35-71 years, Expanded Disability Status Scale 6.5-8.0) and 8 standing assistants (4 female) kept audio diaries of their experiences.
INTERVENTION


The standing frame programme involved two face-to-face home-based physiotherapy sessions to set up the standing frame programme, supplemented by educational material designed to optimise self-efficacy. Participants were encouraged to stand for at least 30 min, three times a week for the 36-week study period.
RESULTS


Four main themes were identified: ""Feeling like the old me""; 'Noticing a difference'; ""I want to do it right"" and ""You have a good day, you have a bad day"".
CONCLUSIONS


Supported standing helped people with progressive MS feel more like their old selves and provided a sense of normality and enjoyment. People noticed improvements in physical and psychological symptoms, which were often associated with increased participation in activities they valued. Provision of support from a physiotherapist and recognition of the variable nature of the condition were highlighted as factors to consider when establishing a standing programme.
TRIAL REGISTRATION NUMBER


ISRCTN69614598.",2020,"CONCLUSIONS


Supported standing helped people with progressive MS feel more like their old selves and provided a sense of normality and enjoyment.","['As part of the RCT, 140 participants', 'people with progressive multiple sclerosis (MS) and their standing assistants during their participation in Standing Up in Multiple Sclerosis', '12 people with progressive MS (6 female, aged 35-71 years, Expanded Disability Status Scale 6.5-8.0) and 8 standing assistants (4 female) kept audio diaries of their experiences', 'people with progressive multiple sclerosis', 'Participants were recruited from eight healthcare organisations in two regions of the UK']",['usual care or usual care plus a standing frame programme'],['physical and psychological symptoms'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183500', 'cui_str': 'Standing frame'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",140.0,0.0555882,"CONCLUSIONS


Supported standing helped people with progressive MS feel more like their old selves and provided a sense of normality and enjoyment.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'School of Health Professions, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'Physiotherapy, MS Therapy Centre, Norwich, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jarrett', 'Affiliation': 'Mardon Neurorehabilitation Centre, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'Research Design Service, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': 'Health Economics Group, University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Freeman', 'Affiliation': 'School of Health Professions, Faculty of Health, University of Plymouth, Plymouth, UK jenny.freeman@plymouth.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-037680']
1900,33115894,"Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial.","OBJECTIVES


Approximately 11%-13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.
DESIGN


Randomised, double-blind controlled trial.
SETTING


Primary and secondary care in The Netherlands, from November 2016 to March 2019.
PARTICIPANTS


67 pregnant women (12-32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).
INTERVENTIONS


Participants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.
PRIMARY AND SECONDARY OUTCOME MEASURES


Depressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.
RESULTS


Median depression scores decreased by 40.6%-53.1% in the BLT group and by 50.9%-66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.
CONCLUSIONS


Depressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.
TRIAL REGISTRATION NUMBER


NTR5476.",2020,"RESULTS


Median depression scores decreased by 40.6%-53.1% in the BLT group and by 50.9%-66.7% in the DRLT group.","['Primary and secondary care in The Netherlands, from November 2016 to March 2019', 'depression during pregnancy', '67 pregnant women (12-32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders']","['bright light therapy', 'dim red light therapy (DRLT', 'placebo', 'BLT', 'Bright light therapy (BLT']","['rating scale scores', 'Hamilton Depression Scale-Seasonal Affective Disorder', 'Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale', 'symptom change scores', 'Depressive symptoms', 'Median depression scores']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",67.0,0.272881,"RESULTS


Median depression scores decreased by 40.6%-53.1% in the BLT group and by 50.9%-66.7% in the DRLT group.","[{'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Bais', 'Affiliation': 'Psychiatry, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands b.bais@erasmusmc.nl.'}, {'ForeName': 'Astrid M', 'Initials': 'AM', 'LastName': 'Kamperman', 'Affiliation': 'Psychiatry, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Hilmar H', 'Initials': 'HH', 'LastName': 'Bijma', 'Affiliation': 'Obstetrics and Gynaecology, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Witte Jg', 'Initials': 'WJ', 'LastName': 'Hoogendijk', 'Affiliation': 'Psychiatry, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Souman', 'Affiliation': 'Lighting Applications, Signify NV, Eindhoven, Noord-Brabant, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Knijff', 'Affiliation': 'Psychiatry, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Mijke P', 'Initials': 'MP', 'LastName': 'Lambregtse-van den Berg', 'Affiliation': 'Psychiatry, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038030']
1901,33115898,Tailored smartphone intervention to promote healthy eating among Brazilian adolescents: a randomised controlled trial protocol.,"INTRODUCTION


Adolescent eating patterns are characterised by high consumption of unhealthy foods, which has resulted in an increasing prevalence of overweight and chronic diseases. It is crucial to promote healthy eating habits, and nutritional interventions based on the transtheoretical model have been found to be especially effective. Mobile health strategies also seem promising for adolescents. This study aims to outline a smartphone intervention via WhatsApp for adolescents to promote healthy eating consumption, better nutritional knowledge, self-efficacy in the adoption of healthy practices and progress through the stages of change.
METHODS AND ANALYSIS


There will be three distinct groups in this randomised study: a general intervention group (GG), in which the participants will receive the same healthy eating messages, based on the Brazilian food guide; a tailored intervention group (TG), in which the participants will receive healthy eating messages based on their stage of change; and a control group (CG), in which participants will receive messages on a different theme. Possession of a smartphone, use of WhatsApp and being a senior student (16-19 years) from a public school of the Federal District of Brazil will be the study's inclusion criteria. Rural schools will be excluded. The sample size estimated is 390 individuals: 38 in the GG, 314 in the TG and 38 in the CG. The intervention will last 6 weeks, with a daily message sent to the students. We will investigate nutritional knowledge, self-efficacy in the adoption of healthy eating practices, food consumption and stages of change using preintervention and postintervention questionnaires. Memorisation of the messages will be also assessed.
ETHICS AND DISSEMINATION


The study was approved by the University of Brasília, School of Health Sciences and Research Ethics Committee. At the end of the study, the participating schools will receive a printed report with the main results of the intervention.
TRIAL REGISTRATION NUMBER


RBR-5b9jk7.",2020,"We will investigate nutritional knowledge, self-efficacy in the adoption of healthy eating practices, food consumption and stages of change using preintervention and postintervention questionnaires.","['390 individuals: 38 in the GG, 314 in the TG and 38 in the CG', 'adolescents to promote healthy eating consumption', 'Rural schools', 'healthy eating among Brazilian adolescents', 'adolescents', ""senior student (16-19 years) from a public school of the Federal District of Brazil will be the study's inclusion criteria""]","['smartphone intervention via WhatsApp', 'healthy eating messages, based on the Brazilian food guide; a tailored intervention group (TG), in which the participants will receive healthy eating messages based on their stage of change; and a control group (CG', 'general intervention group (GG', 'Tailored smartphone intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",[],,0.0678512,"We will investigate nutritional knowledge, self-efficacy in the adoption of healthy eating practices, food consumption and stages of change using preintervention and postintervention questionnaires.","[{'ForeName': 'Giselle Rhaisa', 'Initials': 'GR', 'LastName': 'Melo', 'Affiliation': 'NESNUT- Department of Nutrition, University of Brasilia, Brasilia, Federal District, Brazil giselle-melo1502@hotmail.com.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Correa Lima', 'Affiliation': 'NESNUT- Department of Nutrition, University of Brasilia, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'M Dos Santos Chagas', 'Affiliation': 'NESNUT- Department of Nutrition, University of Brasilia, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Eduardo Y', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Statistics Department, University of Brasília, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'NESNUT- Department of Nutrition, University of Brasilia, Brasilia, Federal District, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-038896']
1902,33115965,Pain Intensity at Injection Site during Esophagogastroduodenoscopy Using Long- and Medium-Chain versus Long-Chain Triglyceride Propofol: A Randomized Controlled Double-Blind Study.,"Background/Aims


: The intensities of injection pain resulting from the use of long- and medium-chain triglyceride (LCT/ MCT) propofol and conventional LCT propofol during esophagogastroduodenoscopy (EGD) have yet to be compared. We aimed to determine the pain intensity caused by different formulations of propofol and to evaluate the formulation that would be preferred by patients as a sedative agent during their next procedure.
Methods


This study was a single-center, randomized, controlled, and double-blind trial. Pain intensity was estimated 30 seconds after propofol injection by an examiner who was blinded to the group assignment using a numeric (0&#8211;10) pain rating scale (NPRS). After 1 week, the patients were asked whether they could recall the pain and were willing to receive the same agent for their next EGD.
Results


One hundred twenty-nine patients were randomly assigned to LCT/MCT or LCT group. Although there was no significant difference in pain incidence between the LCT/ MCT and LCT groups (52.9% vs 65.6%, p=0.156), the pain intensity was significantly lower in the LCT/MCT group (NPRS median [interquartile range]; 1 (0&#8211;2) vs 2 (0&#8211;5), p=0.005). After 1 week, fewer patients in the LCT/MCT group recalled the pain (19.1% vs 63.9%, p<0.001) and more patients in the LCT/MCT group were more willing to use the same agent for their next procedure (86.8% vs 72.1%, p=0.048) than in the LCT group.
Conclusions


LCT/MCT propofol significantly reduced injection pain intensity compared to LCT propofol during EGD and preferred by patients as a sedative agent during their next EGD.",2020,"Conclusions


LCT/MCT propofol significantly reduced injection pain intensity compared to LCT propofol during EGD and preferred by patients as a sedative agent during their next EGD.",['One hundred twenty-nine patients'],"['LCT/MCT', 'LCT/ MCT and LCT', 'long- and medium-chain triglyceride (LCT/ MCT) propofol and conventional', 'Esophagogastroduodenoscopy Using Long- and Medium-Chain versus Long-Chain Triglyceride', 'LCT/MCT propofol', 'LCT propofol', 'propofol', 'LCT propofol during esophagogastroduodenoscopy (EGD', 'LCT/MCT or LCT', 'Propofol']","['injection pain intensity', 'pain incidence', 'intensities of injection pain', 'Pain Intensity', 'pain intensity', 'pain rating scale (NPRS', 'Pain intensity', 'pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0556091', 'cui_str': 'Long chain triglyceride supplementation'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",129.0,0.122512,"Conclusions


LCT/MCT propofol significantly reduced injection pain intensity compared to LCT propofol during EGD and preferred by patients as a sedative agent during their next EGD.","[{'ForeName': 'Joon Seop', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Eun Soo', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Kwang Bum', 'Initials': 'KB', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyung Sik', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Ju Yup', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.'}]",Gut and liver,['10.5009/gnl20243']
1903,31472099,Shifts in the skin microbiome associated with diaper dermatitis and emollient treatment amongst infants and toddlers in China.,"BACKGROUND


The microbiological basis of diaper dermatitis has not been clearly elucidated; however, a better understanding of microbial colonization may be vital for developing appropriate therapies.
METHODS


Using 16S-rRNA gene sequencing technology, we characterized and compared the bacterial communities obtained from the buttock skin sites of children with diaper dermatitis and from healthy controls. Bacterial diversity in the buttock lesion area and subsequent recovery after emollient treatment have been discussed herein.
RESULTS


In buttock skin of children with or without diaper dermatitis, Staphylococcus and Anaerococcus were predominant in the total skin microbiome. Compared with the healthy group, the overall skin bacterial richness and diversity were higher in children with diaper dermatitis, with the abundance of Proteobacteria being significantly higher. In the diaper dermatitis group, the richness of Enterococcus, Erwinia and Pseudomonas was significantly higher, and the levels of Clostridium and Actinomyces were significantly lower than those in healthy children. Richness of Staphylococcus aureus was significantly higher in the diaper dermatitis group, whereas that of Staphylococcus epidermidis and Bifidobacterium longum was lower. Staphylococcus epidermidis and Staphylococcus haemolyticus, the dominant species found in buttock skin, were observed to recover earlier after the disease had improved through emollient treatment.
CONCLUSION


Staphylococcus epidermidis, as skin probiotic bacterium, and B longum, Clostridium butyricum and Lactobacillus ruminis, which are intestinal probiotic bacteria, are significantly decreased in diaper dermatitis lesions. These changes in the buttock skin microflora indicate an imbalance in the microflora and suggest that the intestinal microflora may be undergoing dynamic changes. The results of this study suggest that probiotic bacterial supplementation may be useful in the treatment and prevention of diaper dermatitis.",2019,"In the diaper dermatitis group, the richness of Enterococcus, Erwinia and Pseudomonas was significantly higher, and the levels of Clostridium and Actinomyces were significantly lower than those in healthy children.","['children with diaper dermatitis and from healthy controls', 'infants and toddlers in China']",['probiotic bacterial supplementation'],"['richness of Enterococcus, Erwinia and Pseudomonas', 'Staphylococcus epidermidis and Staphylococcus haemolyticus', 'total skin microbiome', 'overall skin bacterial richness and diversity', 'levels of Clostridium and Actinomyces', 'Richness of Staphylococcus aureus']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011974', 'cui_str': 'Diaper rash'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0014727', 'cui_str': 'Erwinia'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0318114', 'cui_str': 'Staphylococcus haemolyticus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0001250', 'cui_str': 'Actinomyces'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}]",,0.0222096,"In the diaper dermatitis group, the richness of Enterococcus, Erwinia and Pseudomonas was significantly higher, and the levels of Clostridium and Actinomyces were significantly lower than those in healthy children.","[{'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Laiji', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Shanghai Jahwa Corporation, Shanghai, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai Jahwa Corporation, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Gaolei', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Congfen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Beijing Key Lab of Plant Resources Research and Development, Beijing Technology and Business University, Beijing, China.'}]",Experimental dermatology,['10.1111/exd.14028']
1904,31628668,Dose-Dependent Inhibition of OATP1B by Rifampicin in Healthy Volunteers: Comprehensive Evaluation of Candidate Biomarkers and OATP1B Probe Drugs.,"To address the most appropriate endogenous biomarker for drug-drug interaction risk assessment, eight healthy subjects received an organic anion transporting polypeptide 1B (OATP1B) inhibitor (rifampicin, 150, 300, and 600 mg), and a probe drug cocktail (atorvastatin, pitavastatin, rosuvastatin, and valsartan). In addition to coproporphyrin I, a widely studied OATP1B biomarker, we identified at least 4 out of 28 compounds (direct bilirubin, glycochenodeoxycholate-3-glucuronide, glycochenodeoxycholate-3-sulfate, and hexadecanedioate) that presented good sensitivity and dynamic range in terms of the rifampicin dose-dependent change in area under the plasma concentration-time curve ratio (AUCR). Their suitability as OATP1B biomarkers was also supported by the good correlation of AUC 0-24h  between the endogenous compounds and the probe drugs, and by nonlinear regression analysis (AUCR -1  vs. rifampicin plasma C max  (maximum total concentration in plasma)) to yield an estimate of the inhibition constant of rifampicin. These endogenous substrates can complement existing OATP1B-mediated drug-drug interaction risk assessment approaches based on agency guidelines in early clinical trials.",2020,These endogenous substrates can complement existing OATP1B-mediated drug-drug interaction risk assessment approaches based on agency guidelines in early clinical trials.,"['eight healthy subjects', 'Healthy Volunteers']","['Rifampicin', 'organic anion transporting polypeptide 1B (OATP1B) inhibitor (rifampicin', 'probe drug cocktail (atorvastatin, pitavastatin, rosuvastatin, and valsartan']",['plasma concentration-time curve ratio (AUCR'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0003075', 'cui_str': 'Anions'}, {'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",8.0,0.0142373,These endogenous substrates can complement existing OATP1B-mediated drug-drug interaction risk assessment approaches based on agency guidelines in early clinical trials.,"[{'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Mori', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Kimoto', 'Affiliation': 'ADME Sciences, Medicine Design, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rago', 'Affiliation': 'ADME Sciences, Medicine Design, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'King-Ahmad', 'Affiliation': 'ADME Sciences, Medicine Design, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Ragu', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'ADME Sciences, Medicine Design, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Wood', 'Affiliation': 'Clinical Pharmacogenomics Lab, Early Clinical Development, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Jillian G', 'Initials': 'JG', 'LastName': 'Johnson', 'Affiliation': 'Clinical Pharmacogenomics Lab, Early Clinical Development, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Le', 'Affiliation': 'Biostatistics, Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Manoli', 'Initials': 'M', 'LastName': 'Vourvahis', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc., New York, New York, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'David Rodrigues', 'Affiliation': 'ADME Sciences, Medicine Design, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Chieko', 'Initials': 'C', 'LastName': 'Muto', 'Affiliation': 'Pfizer Inc., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Furihata', 'Affiliation': 'P-One Clinic, Keikokai Medical Corp, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'RIKEN Innovation Center, Research Cluster for Innovation, RIKEN, Kanagawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kusuhara', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1695']
1905,31700099,The shape of disposable diaper affects spontaneous movements of lower limbs in young infants.,"This study examined the characteristics of young infants' lower limb spontaneous movements based on differences in shape of diapers. Twenty-seven healthy infants (103 ± 16.3 days old) were enrolled in this study. We measured the spontaneous movements of their lower limbs in four conditions (Naked, wearing Normal type diapers, wearing Type A diapers, and wearing Type B diapers). The Normal diaper has a wider waist belt than the Type A diaper, and the Type B diaper has a narrower crotch area than the Type A diaper. We observed them in seven indices (the velocity of lower limb movements, the trajectory area of knee movement in the sagittal plane and the frontal plane, the distance between both knees and between side of abdomen and knee, and correlation of velocities between side of abdomen and knee and between left and right ankles). The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers. The value for the trajectory area of knee movement in sagittal plane, which reflects the range of lower leg lifting movements and closeness of such movements to the trunk, for the Type B diaper condition was higher than that for the Normal diaper condition. This result indicates that the shape of the diaper affects the spontaneous movements of the lower limbs of young infants.",2019,The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers.,"['Twenty-seven healthy infants (103\u2009±\u200916.3 days old', 'young infants']",[],['velocity of the lower limb movements'],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",27.0,0.0344084,The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers.,"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Gima', 'Affiliation': 'Child Developmental and Learning Research Center, Faculty of Regional Sciences, Tottori University, 4-101 Koyama-Minami, Tottori, 680-8551, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Teshima', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Tagami', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Hidenobu', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'Department of Pyschophysiology, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi-cho, Kodaira, Tokyo, 187-8553, Japan. hideohta@med.akita-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-52471-4']
1906,31721173,A Machine-Learning Approach to Identify a Prognostic Cytokine Signature That Is Associated With Nivolumab Clearance in Patients With Advanced Melanoma.,"Lower clearance of immune checkpoint inhibitors is a predictor of improved overall survival (OS) in patients with advanced cancer. We investigated a novel approach using machine learning to identify a baseline composite cytokine signature via clearance, which, in turn, could be associated with OS in advanced melanoma. Peripheral nivolumab clearance and cytokine data from patients treated with nivolumab in two phase III studies (n = 468 (pooled)) and another phase III study (n = 158) were used for machine-learning model development and validation, respectively. Random forest (Boruta) algorithm was used for feature selection and classification of nivolumab clearance. The 16 top-ranking baseline inflammatory cytokines reflecting immune-cell modulation were selected as a composite signature to predict nivolumab clearance (area under the curve (AUC) = 0.75; accuracy = 0.7). Predicted clearance (high vs. low) via the cytokine signature was significantly associated with OS across all three studies (P < 0.01), regardless of treatment (nivolumab vs. chemotherapy).",2020,"Predicted clearance (high vs. low) via the cytokine signature was significantly associated with OS across all three studies (P < 0.01), regardless of treatment (nivolumab vs. chemotherapy).","['Patients With Advanced Melanoma', 'patients with advanced cancer', 'patients treated with nivolumab in two phase III studies (n\xa0=\xa0468 (pooled)) and another phase III study (n\xa0=\xa0158']",[],"['Predicted clearance', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]",[],"[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",158.0,0.164409,"Predicted clearance (high vs. low) via the cytokine signature was significantly associated with OS across all three studies (P < 0.01), regardless of treatment (nivolumab vs. chemotherapy).","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Saci', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pak', 'Affiliation': 'Information and Data Management, Bristol-Myers Squibb, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Akintunde', 'Initials': 'A', 'LastName': 'Bello', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Rizzo', 'Affiliation': 'Global Clinical Research, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Global Clinical Research, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Moss', 'Affiliation': 'Global Clinical Research, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Oncology Translational Medicine, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Lawrenceville, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1724']
1907,33118401,"The Effect of Peppermint ( Mentha piperita ) Extract on the Severity of Nausea, Vomiting and Anorexia in Patients with Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial.","Background and Objective:  Nausea, vomiting, and anorexia are the most common side effects reported in cancer patients undergoing chemotherapy. The present study aimed to determine the effect of peppermint extract on the severity of nausea, vomiting, and anorexia in patients with breast cancer undergoing chemotherapy.  Methods and Materials:  In this randomized controlled trial, we selected 84 patients with breast cancer undergoing chemotherapy. They were then assigned to 2 groups of experimental and control (n = 42, each) using block randomization. Patients in the experimental group received 40 drops of peppermint extract mixed in 20 cc of tap water every 8 hours, while patients in the control group received 40 drops of distilled water mixed in 20 cc of tap water every 8 hours. The severity of nausea, vomiting, and anorexia was measured and recorded before the intervention, and immediately, 24 and 48 hours after the chemotherapy using the Visual Analogue Scale. Statistical analysis of the data was conducted using SPSS software version 21.  Results:  The results of the present study revealed that there was a significant difference between the 2 groups at 24 and 48 hours after the chemotherapy ( P  < .05), so that the mean score of the severity of nausea, vomiting, and anorexia in the experimental group was lower than in the control group ( P  < .05).  Conclusion:  The use of peppermint as a method in complementary medicine may improve nausea, vomiting, and anorexia in patients with breast cancer undergoing chemotherapy. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.",2020,"The use of peppermint as a method in complementary medicine may improve nausea, vomiting, and anorexia in patients with breast cancer undergoing chemotherapy.","['Patients with Breast Cancer Undergoing Chemotherapy', 'cancer patients undergoing chemotherapy', '84 patients with breast cancer undergoing chemotherapy', 'patients with breast cancer undergoing chemotherapy']","['Peppermint ( Mentha piperita ) Extract', '40 drops of peppermint extract', 'peppermint extract', '40 drops of distilled water mixed in 20\u2009cc of tap water every 8\u2009hours']","['Nausea, vomiting, and anorexia', 'nausea, vomiting, and anorexia', 'severity of nausea, vomiting, and anorexia', 'Visual Analogue Scale', 'mean score of the severity of nausea, vomiting, and anorexia', 'Severity of Nausea, Vomiting and Anorexia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0697157', 'cui_str': 'Mentha piperita'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2919405', 'cui_str': 'Tap water'}, {'cui': 'C0585326', 'cui_str': 'Every eight hours'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",84.0,0.0400676,"The use of peppermint as a method in complementary medicine may improve nausea, vomiting, and anorexia in patients with breast cancer undergoing chemotherapy.","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Jafarimanesh', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Akbari', 'Affiliation': 'Department of Nursing, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Hoseinian', 'Affiliation': 'Department of Radiation and Oncology, Khansari Hospital, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Zarei', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran.'}]",Integrative cancer therapies,['10.1177/1534735420967084']
1908,33118412,Heart Rate Variability and Cardiovascular Adaptations Among Cancer-Survivors Following a 26-Week Exercise Intervention.,"Cardiotoxicity as a result of cancer treatment contributes to autonomic dysfunction and decreased cardiorespiratory fitness among cancer survivors. These deleterious cardiovascular outcomes reduce the survival prognosis for cancer patients and contribute to poor quality of life among survivors. Exercise interventions have been shown as effective in mitigating treatment-related side effects. However, previously published interventions have not explored the potential for improvement in autonomic dysfunction (heart rate variability, HRV). This study examined cardiovascular adaptations in cancer survivors (n = 76) who participated in a 26-week intervention consisting of combined aerobic and resistance training (CART). The most noteworthy improvements occurred during the first 13 weeks of training and were maintained throughout the end of the 26-week period. HR rest  improved from baseline (PRE) to the midpoint (MID) ( P  = .036) and from PRE to POST timepoints ( P  = .029). HRV and VO 2max  did not initially appear to change in response to CART. However, after stratification on time since treatment, participants who were 5 or more years from their last treatment experienced improvements (ie increase) in the HRV characteristic of HF power ( P  = .050) and also in VO 2max  ( P  =.043), when compared to those experiencing less than 5 years of time since their last treatment. These findings highlight a need for more attention to address the cardiorespiratory deficits experienced by those who have recently completed cancer treatment. In conclusion, the CART intervention is effective in improving cardiorespiratory fitness and autonomic dysfunction. The structure of the intervention is feasible for cancer survivors to continue with at home, using minimal resources, and without supervision. This at-home model may be even more acceptable to recent survivors that may be homebound immediately following treatment.",2020,"The structure of the intervention is feasible for cancer survivors to continue with at home, using minimal resources, and without supervision.","['cancer patients', 'cancer survivors', 'cancer survivors (n\u2009=\u200976) who participated in a 26-week intervention consisting of']","['CART intervention', 'combined aerobic and resistance training (CART', 'Exercise interventions', '26-Week Exercise Intervention']","['Cardiotoxicity', 'autonomic dysfunction (heart rate variability, HRV', 'Heart Rate Variability and Cardiovascular Adaptations', 'cardiorespiratory fitness', 'HR rest  improved from baseline (PRE) to the midpoint (MID', 'cardiorespiratory fitness and autonomic dysfunction', 'HRV characteristic of HF power']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444598', 'cui_str': 'Mid'}]",,0.0187588,"The structure of the intervention is feasible for cancer survivors to continue with at home, using minimal resources, and without supervision.","[{'ForeName': 'Silvie', 'Initials': 'S', 'LastName': 'Grote', 'Affiliation': 'Cypress College, Cypress, CA, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Ricci', 'Affiliation': 'Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Dehom', 'Affiliation': 'Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Modeste', 'Affiliation': 'Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Diadrey-Ann', 'Initials': 'DA', 'LastName': 'Sealy', 'Affiliation': 'University of the Southern Caribbean, Port of Spain, Saint Joseph, Trinidad and Tobago.'}, {'ForeName': 'Heather P', 'Initials': 'HP', 'LastName': 'Tarleton', 'Affiliation': 'Loyola Marymount University, Los Angeles, CA, USA.'}]",Integrative cancer therapies,['10.1177/1534735420969816']
1909,33118421,Daily and Not Every-Other-Day Intake of Anthocyanin-Rich New Zealand Blackcurrant Extract Alters Substrate Oxidation during Moderate-Intensity Walking in Adult Males.,"Daily intake of anthocyanin-rich New Zealand blackcurrant (NZBC) extract can enhance exercise-induced fat oxidation. It is not known whether habitual dietary anthocyanin intake and body composition affects blackcurrant-induced fat oxidation or even if daily intake is required. We examined effects of daily and every-other-day intake of NZBC extract on metabolic and physiological responses during moderate-intensity walking. Sixteen physically active males (age: 24   ±   6   yr, body mass: 78   ±   16   kg, BMI: 24.7   ±   4.2   kg· m   -2 , body fat: 15.2   ±   5.0%) volunteered. A randomized, cross-over design with a control condition was used and habitual dietary anthocyanin intake quantified. For intake conditions, participants consumed two capsules of NZBC extract (i.e. 210   mg of anthocyanins, CurraNZ™) with breakfast daily or every-other-day for 14   days (14-D and 14-EOD) with 14-days washout. Final two capsules were taken 2-hr before the walk (speed: 5.7   ±   0.7   km·hr -1 ). There was a trend for lower respiratory exchange ratio and carbohydrate oxidation with changes only for 14-D. Fat oxidation was increased only for 14-D ( p     <   0.05) with 50% of the participants more than a 10% change. In 14-D, there was a positive correlation for BMI and body fat % with the absolute change in fat oxidation but not with habitual dietary anthocyanin intake. Daily intake of NZBC extract is required to enhance exercise-induced fat oxidation. Enhanced exercise-induced fat oxidation by daily intake of NZBC extract is related to body composition but not to habitual dietary anthocyanin intake in physically active males. Daily anthocyanin intake seems to be required to allow the gradual build-up and maintenance of anthocyanin-derived metabolites that are required to alter mechanisms for exercise-induced substrate oxidation.",2020,There was a trend for lower respiratory exchange ratio and carbohydrate oxidation with changes only for 14-D. Fat oxidation was increased only for 14-D ( p     <   0.05) with 50% of the participants more than a 10% change.,"['moderate-intensity walking', 'Sixteen physically active males (age: 24 \u2009 ± \u2009 6 \u2009 yr, body mass: 78 \u2009 ± \u2009 16 \u2009 kg, BMI: 24.7 \u2009 ± \u2009 4.2 \u2009 kg· m   -2 , body fat: 15.2 \u2009 ± \u2009 5.0%) volunteered', 'Adult Males']","['Anthocyanin-Rich New Zealand Blackcurrant Extract Alters Substrate Oxidation', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract']","['metabolic and physiological responses', 'lower respiratory exchange ratio and carbohydrate oxidation', '14-D. Fat oxidation']","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",16.0,0.0391563,There was a trend for lower respiratory exchange ratio and carbohydrate oxidation with changes only for 14-D. Fat oxidation was increased only for 14-D ( p     <   0.05) with 50% of the participants more than a 10% change.,"[{'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Şahin PhD', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Bilgiç PhD', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Montanari MSc', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}, {'ForeName': 'Mark Elisabeth Theodorus', 'Initials': 'MET', 'LastName': 'Willems PhD', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1841356']
1910,33118429,Spirulina platensis  Provides a Small Advantage in Vertical Jump and Sprint Performance But Does Not Improve Elite Rugby Players' Body Composition.,"The present study aimed to examine the effects of  Spirulina  supplementation on anthropometrical measurements and physical performance in elite rugby players. Twenty-two elite male Rugby Union players (21-36 years old) volunteered to participate in this study. They were randomly assigned to a  Spirulina  group (SPI:  n  = 11), or a placebo group (PLA:  n  = 11) in a double-blind design. Subjects were supplemented with  Spirulina platensis  (5.7 g/d) or placebo (isoproteic and caloric) for 7 weeks. At baseline (W 0 ) and after 7 weeks of supplementation (W 7 ), the same anthropometric measurements and physical performance test battery were performed. These tests included isokinetic leg strength and power, vertical jump, speed, and aerobic fitness assessment. For anthropometric data, the fat mass percentage was significantly reduced in both groups without significant difference between groups. While both groups exhibited significant improvements for Squat Jump (SJ), Countermovement Jump (CMJ), and 10- and 30-m sprints between W 0  and W 7 , higher percentage improvements with the SPI group did not reach significance. Neither training alone (PLA) nor training associated with  Spirulina  supplementation affected leg maximal strength and power or aerobic fitness. Seven weeks of  Spirulina  supplementation in elite rugby players did not improve body composition or substantially increase physical performance. We only observed a non-significant small advantage in vertical jump and sprint performance in the SPI group. Based on the data from this study,  Spirulina  supplementation has modest effects in elite rugby players during the competitive phase. Further studies are required to verify  Spirulina  supplementation effects among athletes of different sports, ages, genders, and athletic levels with longer durations and higher dosages.",2020,Neither training alone (PLA) nor training associated with  Spirulina  supplementation affected leg maximal strength and power or aerobic fitness.,"['Twenty-two elite male Rugby Union players (21-36\u2009years old) volunteered to participate in this study', 'elite rugby players']","['Spirulina  group (SPI:  n \u2009=\u200911), or a placebo group (PLA:  n \u2009=\u200911) in a double-blind design', 'Spirulina  supplementation', 'training alone (PLA) nor training associated with  Spirulina  supplementation', 'placebo (isoproteic and caloric']","['Vertical Jump and Sprint Performance', 'anthropometrical measurements and physical performance', ""Elite Rugby Players' Body Composition"", 'leg maximal strength and power or aerobic fitness', 'body composition', 'vertical jump and sprint performance', 'physical performance', 'Squat Jump (SJ), Countermovement Jump (CMJ), and 10- and 30-m sprints', 'fat mass percentage', 'isokinetic leg strength and power, vertical jump, speed, and aerobic fitness assessment']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",22.0,0.0585811,Neither training alone (PLA) nor training associated with  Spirulina  supplementation affected leg maximal strength and power or aerobic fitness.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Chaouachi', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Gautier', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Carnot', 'Affiliation': 'REC Rugby, Rennes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bideau', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Guillemot', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Moison', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Collin', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Vincent', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Groussard', 'Affiliation': 'Laboratoire M2S - UR7470, Univ-Rennes, Rennes, France.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1832639']
1911,33118482,Urological Aspects in Patients with Alkaptonuria: A Case-Control Study.,"This study aimed to evaluate the urinary tract for dynamic function and stones and calcifications in patients with alkaptonuria. Thirty-eight patients were prospectively divided into two groups. Study group (A) involved 17 patients; the average age was 42 years. The control group (B) involved 21 patients; the average age was 37 years. All patients from the two groups underwent uroflowmetry assessment and ultrasonography for the kidneys and urinary bladder, and prostate in two phases (full bladder and empty bladder). Group A-Bladder volume ranged between 400 and 520 cc. The peak flow rate was between 7 and 23 mL/s, with an average of 18.6 mL/s. Flow rate curves shape were acceptable to the normal bell-shape curve in 11 patients. Seven patients (41%) had prostate calcification accounting for 5%-35% of prostate size. Group B-Bladder volume ranged between 290 and 510 cc. The peak flow rate was 8-27 ml/s, with an average of 20 mL/sec. Normal bell shape voiding curves were observed in 17 patients (80%). Four patients (19%) had prostate calcification accounting for 2%-12% of prostate size. Renal measurements on ultrasonography were the same in both groups. Patients with alkaptonuria developed prostate calcification at younger age; they have a slight but not statistically significant reduced peak urinary flow rate and post void residual urine.",2020,Patients with alkaptonuria developed prostate calcification at younger age; they have a slight but not statistically significant reduced peak urinary flow rate and post void residual urine.,"['patients with alkaptonuria', 'Patients with Alkaptonuria', 'Study group (A) involved 17 patients; the average age was 42 years', 'Thirty-eight patients', '21 patients; the average age was 37 years']",['uroflowmetry assessment and ultrasonography'],"['peak flow rate', 'Normal bell shape voiding curves', 'peak urinary flow rate and post void residual urine', 'prostate calcification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002066', 'cui_str': 'Alkaptonuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",38.0,0.0169391,Patients with alkaptonuria developed prostate calcification at younger age; they have a slight but not statistically significant reduced peak urinary flow rate and post void residual urine.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Suoub', 'Affiliation': 'Department of Special Surgery, Faculty of Medicine, Mutah University, Karak, Jordan.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alsbou', 'Affiliation': 'Alkaptonuria Research Office, Faculty of Medicine, Mutah University, Karak, Jordan.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Sawaqed', 'Affiliation': 'Department of Special Surgery, Faculty of Medicine, Mutah University, Karak, Jordan.'}]",American journal of men's health,['10.1177/1557988320969310']
1912,33118519,[Effect of ozone oil for prevention and treatment of sorafenib-induced hand-foot skin reactions: a randomized controlled trial].,"OBJECTIVE


To compare the effects of medical ozone oil and urea ointment for prevention and treatment of hand-foot skin reaction (HFSR) caused by sorafenib in patients with hepatocellular carcinoma (HCC).
METHODS


A total of 99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020. The patients were randomized into medical ozone oil group ( n =49) and urea ointment group (control group,  n =49) for treatment with local application of 1 mL medical ozone oil (experimental group) and 10% urea ointment (2 g) on the palm and plantar skin (including the fingers and joints) for 12 weeks (3 times per day) starting at the beginning of sorafenib treatment, respectively. The patients were observed for occurrence of HFSR every 2 weeks for 14 weeks.
RESULTS


Eight patients were excluded for poor compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in urea ointment group. Sixteen (36.4%) of patients in ozone oil group developed HFSR, a rate significantly lower than that in urea ointment group (57.4%;  P  < 0.05). The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44]  vs  27.7 [13/47]).
CONCLUSIONS


Medical ozone oil can significantly reduce the incidence and severity of HFSR to improve the quality of life of HCC patients receiving sorafenib treatment.",2020,"The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44]  vs  27.7 [13/47]).
","['99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020', 'Eight patients were excluded for poor compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in urea ointment group', 'patients with hepatocellular carcinoma (HCC', 'induced hand-foot skin reactions']","['ozone oil', 'medical ozone oil and urea ointment', 'urea ointment group (control group,  n =49) for treatment with local application of 1 mL medical ozone oil (experimental group) and 10% urea ointment (2 g) on the palm and plantar skin', 'sorafenib', 'medical ozone oil']","['quality of life', 'incidence of grade 2/3 HFSR', 'HFSR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",99.0,0.0335755,"The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44]  vs  27.7 [13/47]).
","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Yiyue', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Wencong', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Cancer Center, Hospital of Integrated Traditional and Western Medicine, Southern Medical University, Guangzhou 510310, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Cancer Center, Hospital of Integrated Traditional and Western Medicine, Southern Medical University, Guangzhou 510310, China.'}, {'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.10.15']
1913,33118602,"Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","OBJECTIVE


To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients.
METHODS


A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks.
RESULTS


There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the ""feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores. The placebo group presented significant improvement on the ""depression"" score after intervention. There were no intolerable adverse effects.
CONCLUSIONS


Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.",2020,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","['People with Fibromyalgia', 'fibromyalgia patients', '17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil', 'patients with fibromyalgia']","['tetrahydrocannabinol (THC)-rich cannabis oil', 'cannabidiol [CBD', 'placebo', 'THC-rich cannabis oil (24.44\u2009mg/mL of THC', 'Placebo', 'THC-Rich Cannabis Oil']","['feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores', 'Fibromyalgia Impact Questionnaire (FIQ', 'baseline FIQ score', 'FIQ score', 'depression"" score', 'intolerable adverse effects', 'symptoms and quality of life', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556617', 'cui_str': 'Cannabis oil'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",17.0,0.529243,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Chaves', 'Affiliation': 'Public Health School, Municipal Health Secretary, Florianopolis, Brazil.'}, {'ForeName': 'Paulo Cesar T', 'Initials': 'PCT', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Internal Medicine, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pelegrini', 'Affiliation': 'Department of Physical Education, Santa Catarina State University, Florianopolis, Brazil.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa303']
1914,33118603,Establishing Central Sensitization-Related Symptom Severity Subgroups: A Multicountry Study Using the Central Sensitization Inventory.,"OBJECTIVES


The goal of this study was to identify central sensitization-related symptom severity subgroups in a large multicountry sample composed of patients with chronic pain and pain-free individuals using the Central Sensitization Inventory (CSI).
METHODS


A large, pooled international (N = 8 countries) sample of chronic pain patients plus healthy subjects (total N = 2,620) was randomly divided into two subsamples for cross-validation purposes. First, a hierarchical cluster analysis (HCA) was performed using CSI item-level data as clustering variables (test sample; N = 1,312). Second, a latent profile analysis (LPA) was conducted to confirm the optimal number of CSI clusters (validation sample; N = 1,308). Finally, to promote implementation in real-world clinical practice, we built a free online Central Sensitization Inventory Symptom Severity Calculator.
RESULTS


In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful. Clusters were labeled as follows: (i) Low Level of CS-Related Symptom Severity, (ii) Medium Level of CS-Related Symptom Severity, and (iii) High Level of CS-Related Symptom Severity.
CONCLUSIONS


Our results indicated that a three-cluster solution clearly captured the heterogeneity of the CSI data. The calculator might provide an efficient way of classifying subjects into the cluster groups. Future studies should analyze the extent to which the CSI cluster classification correlates with other patient-reported and objective signs and symptoms of CS in patients with chronic pain, their associations with clinical outcomes, health-related costs, biomarkers, (etc.), and responsiveness to treatment.",2020,"In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful.","['chronic pain patients plus healthy subjects (total N\u2009=\u20092,620', 'Establishing Central Sensitization-Related Symptom Severity Subgroups', 'patients with chronic pain and pain-free individuals using the Central Sensitization Inventory (CSI']",['HCA'],"['i) Low Level of CS-Related Symptom Severity, (ii) Medium Level of CS-Related Symptom Severity, and (iii) High Level of CS-Related Symptom Severity']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0309131,"In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful.","[{'ForeName': 'Antonio I', 'Initials': 'AI', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy of the Faculty of Health Science at the, University of Malaga, (IBIMA), Malaga, Spain.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Neblett', 'Affiliation': 'PRIDE Research Foundation, Dallas, Texas, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Chiarotto', 'Affiliation': 'Department of Health Sciences, Amsterdam Movement Sciences Research Institute, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kregel', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'C Paul', 'Initials': 'CP', 'LastName': 'van Wilgen', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pitance', 'Affiliation': 'Neuro Musculoskeletal Lab, Institute of Clinical Research (IREC), Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Knezevic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gatchel', 'Affiliation': 'Pain in Motion International Research Group, Vrije Universiteit, Brussels, Belgium.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Mayer', 'Affiliation': 'Department of Orthopedic Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Viti', 'Affiliation': 'FACEit, Italian Association of Integrated Therapy for Cervico-Cranio-Facial Pain and Dysfunction, Barlassina, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Roldan-Jiménez', 'Affiliation': 'Department of Physiotherapy of the Faculty of Health Science at the, University of Malaga, (IBIMA), Malaga, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Campus of Savona, Savona, Italy.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Jeremic-Knezevic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Nishigami', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, Hiroshima, Japan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa210']
1915,33118624,Patient-reported outcomes in the setting of a randomized control trial on the efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome.,"AIM


To compare the efficacy of transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS) regarding patient-reported outcomes measures, specifically quality-of-life (QoL) improvement and patient's treatment benefit, on symptoms associated with overactive bladder (OAB).
METHODS


Patients with refractory OAB symptoms and detrusor overactivity were randomized to receive TTNS or PTNS for 12 weeks. Data from self-report OAB questionnaire short form (q-SF) and incontinence (I)-QoL questionnaires were collected pretreatment and at Weeks 6 and 12. Patients' self-perceived benefits on symptoms (treatment benefit scale, TBS) were also gathered. Mean change in scores within and between groups were estimated.
RESULTS


Sixty-eight adult patients (67.6% women) were included in the intention to treat analysis. Of those, 61 completed all questionnaires and were analyzed as per protocol. Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p < .001), being the differences much higher than the minimal important difference in both questionnaires. The scores of the OAB-q-SF scales (symptoms bother and health-related QoL) showed no statistically significant differences between the two groups. Similarly, the differences regarding the I-QoL questionnaire were statistically nonsignificant either (p = .607). When assessing the treatment benefit on symptoms, TBS responses between groups showed no statistical differences.
CONCLUSION


A significant improvement of QoL was observed in both TTNS and PTNS groups. However, no patient-reported outcomes measures scores support a difference between the two groups. Therefore, these findings along with TTNS ease of application and less invasiveness may lead to an increased indication of this technique for OAB.",2020,"Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p < .001), being the differences much higher than the minimal important difference in both questionnaires.","['Patients with refractory OAB symptoms and detrusor overactivity', 'idiopathic overactive bladder syndrome', 'Sixty-eight adult patients (67.6% women']","['transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS', 'TTNS', 'TTNS or PTNS', 'transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation']","['I-QoL questionnaire', 'QoL', ""Patients' self-perceived benefits on symptoms (treatment benefit scale, TBS"", 'scores of the OAB-q-SF scales (symptoms bother and health-related QoL', 'OAB questionnaire\xa0short form (q-SF) and incontinence\xa0(I)-QoL questionnaires', 'OAB-q-SF and I-QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3805249', 'cui_str': 'Percutaneous tibial nerve stimulation'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",68.0,0.0420038,"Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p < .001), being the differences much higher than the minimal important difference in both questionnaires.","[{'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Ramírez-García', 'Affiliation': 'RAPbarcelona Physiotherapy Clinical Center, Barcelona, Spain.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Kauffmann', 'Affiliation': 'RAPbarcelona Physiotherapy Clinical Center, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Blanco-Ratto', 'Affiliation': 'RAPbarcelona Physiotherapy Clinical Center, Barcelona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carralero-Martínez', 'Affiliation': 'RAPbarcelona Physiotherapy Clinical Center, Barcelona, Spain.'}, {'ForeName': 'Emília', 'Initials': 'E', 'LastName': 'Sánchez', 'Affiliation': 'Physiotherapy Department, Blanquerna School of Health Science, Ramon Llull University, Barcelona, Spain.'}]",Neurourology and urodynamics,['10.1002/nau.24554']
1916,33118628,Smartphone data during the COVID-19 pandemic can quantify behavioral changes in people with ALS.,"INTRODUCTION/AIMS


Passive data from smartphone sensors may be useful for healthcare research. Our aim was to use the COVID-19 pandemic as positive control to assess the ability to quantify behavioral changes in people with amyotrophic lateral sclerosis (ALS) from smartphone data.
METHODS


Eight participants used the Beiwe smartphone application which passively measured their location during the COVID-19 outbreak. We used interrupted time series to quantify the effect of the US state of emergency declaration on daily home time and daily distance traveled.
RESULTS


After the state of emergency declaration, median daily home time increased from 19.4 hours (IQR: 15.4-22.0) to 23.7 hours (IQR: 22.2-24.0) and median distance traveled decreased from 42 km (IQR: 13-83) to 3.7 km (IQR: 1.5-10.3). The participant with the lowest functional ability changed behavior earlier. This participant stayed at home more and traveled less than the participant with highest functional ability, both before and after the state of emergency.
DISCUSSION


We provide evidence that smartphone-based digital phenotyping can quantify the behavior of people with ALS. Even though participants spent large amounts of time at home at baseline, the COVID-19 state of emergency declaration reduced their mobility further. Given participants' high daily home time, it is possible that their exposure to COVID-19 could be lower than that of the general population.",2020,"This participant stayed at home more and traveled less than the participant with highest functional ability, both before and after the state of emergency.
","['people with amyotrophic lateral sclerosis (ALS', 'Eight participants used the Beiwe smartphone application which passively measured their location during the COVID-19 outbreak', 'people with ALS']",[],"['median daily home time', 'median distance traveled']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]",,0.0443086,"This participant stayed at home more and traveled less than the participant with highest functional ability, both before and after the state of emergency.
","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Beukenhorst', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Collins', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Burke', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Syed Minhajur', 'Initials': 'SM', 'LastName': 'Rahman', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Clapp', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, Missouri.'}, {'ForeName': 'Sai Charan', 'Initials': 'SC', 'LastName': 'Konanki', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, Missouri.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Onnela', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts.'}]",Muscle & nerve,['10.1002/mus.27110']
1917,33118638,"Predictors of treatment response durability in psychotherapy for binge-eating disorder: Examining the roles of self-discrepancy, self-directed style, and emotion dysregulation.","OBJECTIVE


To examine changes in hypothesized maintenance mechanisms during treatment as predictors of treatment response durability in binge-eating disorder (BED) treatment, using data from a randomized clinical trial comparing the efficacy of Integrative Cognitive-Affective Therapy for BED with cognitive-behavioral therapy delivered using guided self-help.
METHOD


Adults with BED (N = 112) received 17 weeks of treatment. Regression models were conducted to examine the extent to which changes in hypothesized maintenance mechanisms from baseline to end of treatment predicted treatment outcomes at 6-month follow-up, adjusting for demographics, study site, and baseline level of treatment outcome.
RESULTS


During-treatment reductions in negative self-directed style and emotion dysregulation predicted reductions in the primary treatment outcome (i.e., binge-eating episode frequency) at follow-up. During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy. Increases in positive self-directed style (e.g., self-affirmation) and reductions in negative self-directed style (e.g., self-blame) during treatment each predicted improvements in anxiety symptoms at follow-up. When predictors were examined simultaneously, the most salient predictors of treatment response durability identified were negative self-directed style for binge-eating episode frequency, actual-ought self-discrepancy and emotion dysregulation for depressive symptoms, and emotion dysregulation for anxiety symptoms. No predictors emerged as most salient for global ED psychopathology.
DISCUSSION


Results indicate that negative self-directed style and emotion dysregulation are particularly important treatment targets in relation to behavioral treatment outcomes in BED.",2020,"During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy.","['binge-eating disorder (BED', 'Adults with BED (N =\u2009112', 'binge-eating disorder']","['Integrative Cognitive-Affective Therapy for BED with cognitive-behavioral therapy delivered using guided self-help', 'psychotherapy']","['emotion dysregulation', 'global ED psychopathology', 'anxiety symptoms', 'global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms', 'negative self-directed style for binge-eating episode frequency, actual-ought self-discrepancy and emotion dysregulation for depressive symptoms, and emotion dysregulation for anxiety symptoms', 'positive self-directed style (e.g., self-affirmation) and reductions in negative self-directed style']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0199659,"During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy.","[{'ForeName': 'Vivienne M', 'Initials': 'VM', 'LastName': 'Hazzard', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, California, Los Angeles, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}]",The International journal of eating disorders,['10.1002/eat.23389']
1918,33118675,"Comparative study of intralesional tuberculin protein purified derivative (PPD) and intralesional measles, mumps, rubella (MMR) vaccine for multiple resistant warts.","BACKGROUND


Cutaneous warts are frequent conditions that possess much challenge to treat.
OBJECTIVE


To evaluate safety and efficacy of intralesional injection of tuberculin purified protein derivative (PPD) antigen injection vs MMR (mumps, measles, rubella) antigen for the treatment of multiple warts.
METHODS


The study included 90 Patients who were divided into three groups (A, B, and C). Each group consisted of (30) patients. Group (A) subjects received intralesional PPD injections. Group (B) subjects received intralesional MMR antigen injection and Group (C) received intralesional saline injection.
RESULTS


Full clearance of warts was observed in 18 (60%) of patients in group (A) (70%) vs 24 patients (80%) in group (B). Distal warts completely disappeared in 18 (60%) of patients in group A and 12 (40%) of patients in group B. Infrequent side effects including pain, erythema, and minimal induration were reported in both groups.
CONCLUSION


We established a good safety and efficacy profile for tuberculin PPD and MMR antigens in resistant wart treatment.",2020,"Distal warts completely disappeared in 18 (60%) of patients in group A and 12 (40%) of patients in group B. Infrequent side effects including pain, erythema, and minimal induration were reported in both groups.
","['90 Patients who were divided into three groups (A, B, and C', 'multiple resistant warts']","['tuberculin purified protein derivative (PPD) antigen injection vs MMR', 'intralesional MMR antigen injection and Group (C) received intralesional saline injection', 'intralesional tuberculin protein purified derivative (PPD) and intralesional measles, mumps, rubella (MMR) vaccine', 'intralesional PPD injections']","['Distal warts', 'pain, erythema, and minimal induration', 'Full clearance of warts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]","[{'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",90.0,0.0224055,"Distal warts completely disappeared in 18 (60%) of patients in group A and 12 (40%) of patients in group B. Infrequent side effects including pain, erythema, and minimal induration were reported in both groups.
","[{'ForeName': 'Yaser F', 'Initials': 'YF', 'LastName': 'Mohammed', 'Affiliation': 'Department of Dermatology, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hany S', 'Initials': 'HS', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Dermatology, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Marwa A', 'Initials': 'MA', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Dermatology, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed L', 'Initials': 'ML', 'LastName': 'Elsaie', 'Affiliation': 'Department of Dermatology, National Research Centre, Giza, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13634']
1919,33116362,Ocular Surface Changes After Switching from Other Prostaglandins to Tafluprost and Preservative-Free Tafluprost in Glaucoma Patients.,"Purpose


To study ocular surface disease (OSD) changes after switching from preserved prostaglandin analogues monotherapy to preserved tafluprost and preservative-free (PF) tafluprost in primary open-angle glaucoma patients.
Methods


Glaucoma patients treated with preserved prostaglandins (except tafluprost) monotherapy for at least 6 months, intraocular pressure (IOP) ≤22 mmHg, and diagnosed of OSD [≥1 criterion; tear break-up time (TBUT) ≤10 seconds, corneal fluorescein staining ≥grade 1] in both eyes were enrolled in a prospective, randomized, single-blinded study. All eligible patients were switched from preserved prostaglandin analogues monotherapy (latanoprost, bimatoprost, travoprost) to preserved tafluprost in one eye (group I) and PF-tafluprost in the other eye (group II) of the same patient by randomization. The symptoms of OSD were evaluated using the visual analogue scale, and lid inflammation, conjunctival hyperemia, TBUT, corneal fluorescein staining, and Schirmer I test were applied to assess the clinical signs. All parameters were evaluated before and then 6, 12, 24 weeks after switching the medications.
Results


Thirty patients (80% women; mean age: 61.2 ±11.5 years) were included. Baseline parameters were not different between the treatment groups. After switching therapies, TBUT was significantly increased in both groups (p = 0.002, p = 0.004, respectively); however, group II had better tear quality. Other symptoms and clinical signs of OSD were improved and IOP was controlled in both groups.
Conclusion


Treatment with PF-tafluprost improves TBUT better than preserved tafluprost, suggesting that PF-tafluprost should be especially beneficial for patients with pre-existing OSD. Less or no preservative anti-glaucoma eye drops can restore and enhance the ocular surface in glaucoma patients.",2020,"After switching therapies, TBUT was significantly increased in both groups (p = 0.002, p = 0.004, respectively); however, group II had better tear quality.","['primary open-angle glaucoma patients', 'All eligible patients were switched from preserved prostaglandin analogues monotherapy (latanoprost, bimatoprost, travoprost) to preserved tafluprost in one eye (group I) and PF-tafluprost in the other eye (group II) of the same patient by randomization', 'Thirty patients (80% women; mean age: 61.2 ±11.5 years) were included', 'glaucoma patients', 'Glaucoma Patients']","['prostaglandin analogues monotherapy', 'preserved prostaglandins (except tafluprost) monotherapy']","['Ocular Surface Changes', 'symptoms of OSD', 'tear quality', 'ocular surface', 'visual analogue scale, and lid inflammation, conjunctival hyperemia, TBUT, corneal fluorescein staining, and Schirmer', 'TBUT']","[{'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}, {'cui': 'C1451502', 'cui_str': 'tafluprost'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C1451502', 'cui_str': 'tafluprost'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}]",80.0,0.029134,"After switching therapies, TBUT was significantly increased in both groups (p = 0.002, p = 0.004, respectively); however, group II had better tear quality.","[{'ForeName': 'Ngamkae', 'Initials': 'N', 'LastName': 'Ruangvaravate', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Karnthida', 'Initials': 'K', 'LastName': 'Choojun', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjawan', 'Initials': 'B', 'LastName': 'Srikulsasitorn', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jatupol', 'Initials': 'J', 'LastName': 'Chokboonpiem', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Dechathon', 'Initials': 'D', 'LastName': 'Asanatong', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Trakanwitthayarak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S264984']
1920,33116374,Comparison of Visual Performance and Patient Satisfaction Outcomes with Two Trifocal IOLs with Similar Optical Design but Different Materials.,"Purpose


To compare clinical outcomes in a prospective trial of cataract surgery patients bilaterally implanted with two different trifocal intraocular lenses (IOLs) with very similar optical designs but consisting of different IOL materials (hydrophobic and hydrophilic).
Patients and Methods


Fifty-one patients (102 eyes) were randomized to receive trifocal IOLs bilaterally - FineVision POD F (hydrophilic) or FineVision POD F GF (hydrophobic) (both PhysIOL, Liége, Belgium). The follow-up period was 3 months. Outcome measurements included uncorrected distance (UDVA), corrected distance (CDVA), distance-corrected intermediate (DCIVA), and distance-corrected near visual acuity (DCNVA), refraction, negative dysphotopsia, optical quality of vision, contrast sensitivity under photopic and mesopic conditions, halometry (discrimination index), and patient-reported outcomes.
Results


At the final study visit, mean (SD) values for binocular UDVA, CDVA, DCIVA (80 cm), and DCNVA (40 cm) were -0.01 (0.06), -0.04 (0.04), 0.09 (0.10), and 0.10 (0.09) logMAR, respectively, for POD F, and 0.01 (0.08), -0.03 (0.03), 0.08 (0.1), and 0.13 (0.11) respectively, for POD F GF. Defocus assessments showed a continuous curve with a functional range of visual acuity (≤0.15 logMAR) from ~30 cm to infinity in both groups. The discrimination index was >0.85 for all patients, and both groups showed similar contrast sensitivity under photopic and mesopic conditions. At 3 months, no patient reported negative dysphotopsia, and high satisfaction rates were observed.
Conclusion


Clinical outcomes showed no significant difference between each lens when measured at 1 month and 3 months after implantation. This equally good clinical performance of hydrophilic and hydrophobic trifocal lenses allows the surgeon to choose the IOL material based on personal preferences or patients' needs.",2020,"The discrimination index was >0.85 for all patients, and both groups showed similar contrast sensitivity under photopic and mesopic conditions.",['Patients and Methods\n\n\nFifty-one patients (102 eyes'],"['hydrophilic and hydrophobic trifocal lenses', 'cataract surgery patients bilaterally implanted with two different trifocal intraocular lenses (IOLs', 'trifocal IOLs bilaterally - FineVision POD F (hydrophilic) or FineVision POD F GF (hydrophobic) (both PhysIOL, Liége, Belgium']","['negative dysphotopsia, and high satisfaction rates', 'mean (SD) values for binocular UDVA, CDVA, DCIVA (80 cm), and DCNVA (40 cm', 'functional range of visual acuity', 'uncorrected distance (UDVA), corrected distance (CDVA), distance-corrected intermediate (DCIVA), and distance-corrected near visual acuity (DCNVA), refraction, negative dysphotopsia, optical quality of vision, contrast sensitivity under photopic and mesopic conditions, halometry (discrimination index), and patient-reported outcomes', 'discrimination index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C1644716', 'cui_str': 'Negative dysphotopsia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.0669082,"The discrimination index was >0.85 for all patients, and both groups showed similar contrast sensitivity under photopic and mesopic conditions.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pérez', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'López-Brea', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rico', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'Miranza IOA, Madrid, Spain.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S273641']
1921,33116381,Dexamethasone/Netilmicin Eye Drops and Eye Gel for the Treatment of Ocular Inflammation After Micro-Incisional Vitreoretinal Surgery.,"Purpose


To evaluate the effect of dexamethasone/netilmicin (dexa/net) fixed combination in the treatment of ocular inflammation after sutureless micro-incisional vitreoretinal surgery (MIVS).
Patients and Methods


This multicenter, open, randomized, active-controlled, parallel-group, clinical trial was run in 6 sites in Italy. Treatment started the day of surgery and continued 4 times daily for 14 days. Patients were 1:1 randomized to dexa/net (eyedrops solution and eye gel) or dexamethasone/tobramycin (dexa/tobra) eyedrops suspension and ointment. Viscous formulations (gel or ointment) were used alone during the early post-operative phase; afterwards, a combination of eye drops during daytime and viscous formulations at bedtime was adopted. The primary efficacy parameter evaluated was bulbar conjunctival hyperemia. Additional efficacy and safety parameters (palpebral conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort and ocular tolerance, adverse events and intraocular pressure) were also evaluated. Control visits were performed at day 1, day 4 and day 14 after surgery; the endpoint of the study was set at 14±2 days after surgery.
Results


A complete resolution of bulbar conjunctiva hyperaemia at the study end point was reached in 92.9% of patients treated with dexa/net and 75.0% of those treated with dexa/tobra (p=0.02, Fisher's exact test). No differences were observed between treatments for other efficacy parameters. Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used. No increase in intraocular pressure or adverse events was observed during the study.
Conclusion


The combination dexa/net is safe and effective in the treatment of post-operative inflammation following sutureless MIVS. In particular, the use of eye gel formulation is characterized by a great tolerability.",2020,"Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used.",['6 sites in Italy'],"['Dexamethasone/Netilmicin Eye Drops and Eye Gel', 'sutureless micro-incisional vitreoretinal surgery (MIVS', 'dexamethasone/netilmicin (dexa/net) fixed combination', 'dexa/net (eyedrops solution and eye gel) or dexamethasone/tobramycin (dexa/tobra) eyedrops suspension and ointment', 'Viscous formulations (gel or ointment', 'Micro-Incisional Vitreoretinal Surgery']","['bulbar conjunctival hyperemia', 'ocular inflammation', 'subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning', 'Ocular Inflammation', 'favour of dexa/net', 'bulbar conjunctiva hyperaemia', 'intraocular pressure or adverse events', 'Additional efficacy and safety parameters (palpebral conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort and ocular tolerance, adverse events and intraocular pressure']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0027780', 'cui_str': 'Netilmicin'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0991531', 'cui_str': 'Eye gel'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1276848', 'cui_str': 'Dexamethasone- and tobramycin-containing product'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0027780', 'cui_str': 'Netilmicin'}, {'cui': 'C0858905', 'cui_str': 'Bulbar conjunctiva hyperaemia'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}]",,0.0523738,"Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rapisarda', 'Affiliation': 'Department of Ophthalmology, Azienda Ospedaliera Garibaldi, Catania, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Arpa', 'Affiliation': 'Department of Ophthalmology, Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Paolo Maria', 'Initials': 'PM', 'LastName': 'Fantaguzzi', 'Affiliation': 'Department of Ophthalmology, Ospedale Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Faraldi', 'Affiliation': 'Department of Ophthalmology, Presidio Ospedaliero Oftalmico, Torino, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ratiglia', 'Affiliation': 'Department of Ophthalmology, Policlinico Mangiagalli Regina Elena, Milano, Italy.'}, {'ForeName': 'Stanislao', 'Initials': 'S', 'LastName': 'Rizzo', 'Affiliation': 'Department of Ophthalmology, Azienda Ospedaliera Pisana, Pisa, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vaona', 'Affiliation': 'Department of Ophthalmology, Presidio Ospedaliero Oftalmico, Torino, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Iannacone', 'Affiliation': 'Sparc Consulting, Milano, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Papa', 'Affiliation': 'Medical Affairs, SIFI SpA, Catania, Italy.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S257541']
1922,33116410,"Pharmacokinetics and Bioequivalence of Two Formulations of Valsartan 80 mg Capsules: A Randomized, Single Dose, 4-Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions.","Purpose


To compare the bioequivalence of two formulations of valsartan (80 mg capsules) under fasting and fed conditions in healthy Chinese volunteers using a full-replicate study design.
Methods


A total of 78 Subjects were randomly assigned to fasting cohort (n = 48) or fed cohort (n = 30). Each cohort includes 4 single-dose observation periods and 3-day washout periods. Blood samples were collected at designed time point. Plasma concentration of valsartan was analyzed by a validated LC-MS/MS method. Noncompartmental analysis method was employed to determine the pharmacokinetic parameters. Based on the within-subject standard deviation (S WR ) of the reference formulation, either reference-scaled average bioequivalence (RSABE) or average bioequivalence (ABE) method was used to evaluate the bioequivalence of the two formulations.
Results


Under fasting conditions, the RSABE method was used to evaluate the bioequivalence of C max  (S WR >0.294), while ABE method was used to evaluate the bioequivalence of AUC 0-t  and AUC 0-∞ . The geometric mean ratio (GMR) of the test/reference for C max  was 99.52%, and the 95% upper confidence bound was <0. For AUC 0-t  and AUC 0-∞  comparisons, GMRs were 102.07% and 101.92%, and the 90% CIs of the test/reference were 96.28%-108.21%, 96.28%-107.88%, respectively. Under fed conditions, the S WR  value of C max , AUC 0-t  and AUC 0-∞  all exceeded the cutoff value of 0.294 and therefore, the RSABE method was used. The GMRs for C max , AUC 0-t  and AUC 0-∞  were 98.78%, 103.33% and 103.08%, respectively, while the 95% upper confidence bound values were all <0. These results all met the bioequivalence criteria for highly variable drugs. All adverse events were mild and transient.
Conclusion


In this study, the generic formulation of valsartan 80 mg capsule was considered to be bioequivalent to the reference product under both fasting and fed conditions, and satisfied the requirements for marketing in China.
NMPA Registration No


CTR20181422.",2020,"The GMRs for C max , AUC 0-t  and AUC 0-∞  were 98.78%, 103.33% and 103.08%, respectively, while the 95% upper confidence bound values were all <0.","['healthy Chinese volunteers using a full-replicate study design', 'Healthy Chinese Volunteers', 'Methods\n\n\nA total of 78 Subjects were randomly assigned to fasting cohort (n = 48) or fed cohort (n = 30']","['Valsartan 80 mg Capsules', 'valsartan']","['GMRs for C max , AUC 0-t  and AUC 0-∞', 'Plasma concentration of valsartan', 'geometric mean ratio (GMR) of the test/reference for C max', 'bioequivalence of C max']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0991107', 'cui_str': 'valsartan 80 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",78.0,0.0369038,"The GMRs for C max , AUC 0-t  and AUC 0-∞  were 98.78%, 103.33% and 103.08%, respectively, while the 95% upper confidence bound values were all <0.","[{'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Changzhou Siyao Pharmaceuticals Co., Ltd, Jiangsu, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Kanyin E', 'Initials': 'KE', 'LastName': 'Zhang', 'Affiliation': ""ViaClinical Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center Laboratory, Shanghai Xuhui Central Hospital, Shanghai, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S253078']
1923,33116738,"A Split-Face Study Assessing the Clinical Benefit, Tolerability and Subject Satisfaction of a Dermocosmetic in Subjects with Rosacea Associated with Erythema and Sensitive Skin.","Objective


This study assessed the efficacy and tolerability of M89 in patients with rosacea associated with erythema and sensitive skin.
Methods


Intra-individual study in a split-face design comparing after 30 days M89 twice daily and usual skin care in 20 adult subjects with rosacea and sensitive skin. M89 contains 89% Vichy volcanic mineralizing water (VVMW) and 0.4% hyaluronic acid. It is hypoallergenic and contains no perfume and this convenes in rosacea. Contained minerals reinforce the natural defences of the skin in restoring the natural skin barrier, stimulating antioxidant activity and reducing inflammation, commonly observed in subjects with rosacea. Clinical evaluations included assessment of erythema, desquamation, papules and pustules, skin tightness, dryness, burning sensation, itching, stinging and stinging test as well as local tolerability. Instrumental evaluations included skin hydration and TEWL. Subject satisfaction was assessed at Days 15 and 30. Demodex density was assessed at Day 30.
Results


A significant superiority of M89 over the standard skin care was observed for erythema, skin tightness and dryness (all P≤0.05) as early as Day 15, the skin stinging test was significantly in favour of M89 (P<0.05 at Day 15 and P<0.01 at Day 30) and for skin hydration (P<0.0001) at Day 15 and 30 with no difference in mean Demodex density between M89 and usual skin care after 30 days. Tolerance was excellent and subject satisfaction very high.
Conclusion


Study results concerning M89 are encouraging for its use either alone or as an adjuvant daily skin care to topical medication in patients with persistent centrofacial erythema of rosacea with no more than 3 papules and pustules.",2020,"A significant superiority of M89 over the standard skin care was observed for erythema, skin tightness and dryness (all P≤0.05) as early as Day 15, the skin stinging test was significantly in favour of M89 (P<0.05 at Day 15 and P<0.01 at Day 30) and for skin hydration (P<0.0001) at Day 15 and 30 with no difference in mean Demodex density between M89 and usual skin care after 30 days.","['patients with persistent centrofacial erythema of rosacea with no more than 3 papules and pustules', 'subjects with rosacea', 'patients with rosacea associated with erythema and sensitive skin', '20 adult subjects with rosacea and sensitive skin', 'Subjects with Rosacea Associated with Erythema and Sensitive Skin']",['hyaluronic acid'],"['skin stinging test', 'skin hydration', 'Subject satisfaction', 'mean Demodex density', 'erythema, skin tightness and dryness', 'efficacy and tolerability', 'skin hydration and TEWL', 'erythema, desquamation, papules and pustules, skin tightness, dryness, burning sensation, itching, stinging and stinging test as well as local tolerability', 'Demodex density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4228089', 'cui_str': 'Sensitive skin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C1274926', 'cui_str': 'Stinging of skin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0323683', 'cui_str': 'Demodex'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0241166', 'cui_str': 'Skin tightness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",20.0,0.0179577,"A significant superiority of M89 over the standard skin care was observed for erythema, skin tightness and dryness (all P≤0.05) as early as Day 15, the skin stinging test was significantly in favour of M89 (P<0.05 at Day 15 and P<0.01 at Day 30) and for skin hydration (P<0.0001) at Day 15 and 30 with no difference in mean Demodex density between M89 and usual skin care after 30 days.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Berardesca', 'Affiliation': 'Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Bonfigli', 'Affiliation': 'ISPE, Milano, Italy.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cribier', 'Affiliation': 'Clinique Dermatologique, University Hospital, Strasbourg, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Flament', 'Affiliation': ""L'Oréal Research and Innovation, Chevilly-Larue, France.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vicic', 'Affiliation': ""L'Oréal Research and Innovation, Chevilly-Larue, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Kerob', 'Affiliation': 'Laboratoires Vichy International, Levallois-Perret, France.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Western University, Department of Medicine and Windsor Clinical Research Inc, Windsor, ON, Canada.'}]","Clinical, cosmetic and investigational dermatology",['10.2147/CCID.S266879']
1924,33116743,No Significant Effect of Daikenchuto (TJ-100) on Peritoneal IL-9 and IFN-γ Levels After Pancreaticoduodenectomy.,"Aim and Background


TJ-100 is a traditional Japanese medicine that affects inflammation and gastrointestinal motility, and is used as a preventive and treatment for paralytic ileus. This study aims at determining the effect of TJ-100 on the peritoneal levels of IFN-γ/IL-9, cytokines related to ileus, after pancreaticoduodenectomy (PD) in a clinical setting.
Methods


This was a subsidiary study of the clinical trial investigating the effect of TJ-100 on postoperative bowel function. Ascites was collected from 180 patients using an abdominal drainage tube on postoperative day 1 and 3 after PD (POD 1 or POD 3) and used to measure 27 cytokines. We performed univariate and multivariate analyses using several perioperative variables and administration of TJ-100/placebo to determine the effect of TJ-100 on the levels of IFN-γ and IL-9.
Results


Peritoneal levels of IL-9 and IFN-γ decreased between POD 1 and 3 (Wilcoxon signed-rank test p<0.001). Multivariate analysis was performed after univariate analysis to select the variables and patients with a body mass index of ≥22 kg/m 2 , older age, use of epidural anesthesia, and longer surgery correlated with the levels of IL-9 and IFN-γ. However, we could not detect a correlation between the use of TJ-100 and cytokine levels in ascites either on POD 1 or 3.
Conclusion


TJ-100 did not affect peritoneal IL-9 and IFN-γ levels after PD. This was in accordance with published clinical findings showing no improvement in bowel function after PD and TJ-100 treatment.",2020,"This study aims at determining the effect of TJ-100 on the peritoneal levels of IFN-γ/IL-9, cytokines related to ileus, after pancreaticoduodenectomy (PD) in a clinical setting.
",[],"['Daikenchuto (TJ-100', 'TJ-100']","['TJ-100 and cytokine levels', 'Peritoneal levels of IL-9 and IFN-γ', 'Peritoneal IL-9 and IFN-γ Levels', 'peritoneal IL-9 and IFN-γ levels', 'levels of IL-9 and IFN-γ', 'postoperative bowel function', 'bowel function']",[],"[{'cui': 'C0909027', 'cui_str': 'dai-kenchu-to'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0085424', 'cui_str': 'Interleukin-9'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",180.0,0.0994272,"This study aims at determining the effect of TJ-100 on the peritoneal levels of IFN-γ/IL-9, cytokines related to ileus, after pancreaticoduodenectomy (PD) in a clinical setting.
","[{'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Kochi Medical School, Nankoku, Kochi 780-8505, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Okada', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama 641-8510, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama 930-0194, Japan.'}, {'ForeName': 'Mari S', 'Initials': 'MS', 'LastName': 'Oba', 'Affiliation': 'Department of Medical Statistics Faculty of Medicine, Toho University, Ota-ku, Tokyo 143-8540, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama 641-8510, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Hirono', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama 641-8510, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': 'Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Showa-ku, Nagoya 466-8560, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Sho', 'Affiliation': 'Department of Surgery, Nara Medical University, Kashihara, Nara 634-8521, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Akahori', 'Affiliation': 'Department of Surgery, Nara Medical University, Kashihara, Nara 634-8521, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Yoshiyasu', 'Initials': 'Y', 'LastName': 'Ambo', 'Affiliation': 'Department of Surgery, Teine-Keijinkai Hospital, Sapporo, Hokkaido 006-8555, Japan.'}, {'ForeName': 'Naru', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Ohuchida', 'Affiliation': 'Department of Surgery, Miyazaki Prefectural Miyazaki Hospital, Miyazaki 889-1692, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nagano', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, Kakamigahara, Gifu 504-8601, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaue', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama 641-8510, Japan.'}]",Clinical and experimental gastroenterology,['10.2147/CEG.S262082']
1925,33116789,"Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section: A Randomized, Double-Blind Clinical Trial.","Purpose


Effective postoperative analgesia is essential in cesarean section. This study aimed to compare postoperative analgesia and hemodynamic changes after intrathecal use of fentanyl or dexmedetomidine combined with bupivacaine.
Patients and Methods


This study involved 110 pregnant women with ASA I and II and gestational age ≥37 weeks who were candidates for elective cesarean section. They were randomly divided into two groups of 55; Group B-D received 10 mg bupivacaine (0.5%) + 5 μg dexmedetomidine and Group B-F received 10 mg bupivacaine (0.5%) + 25 μg fentanyl, intrathecally. The onset of block, duration of analgesia, the score of pain intensity, hemodynamic changes, Apgar scores, and any adverse events were evaluated.  P -value <0.05 was considered statistically significant.
Results


Patients in two groups were similar in terms of demographic characteristics and ASA classification. Duration of analgesia in the B-D group was significantly longer than B-F group (428.64±73.39 vs 273.18±61.91 min;  P <0.001). The score of pain intensity during recovery time in the B-D group was significantly lower than that of B-F group (0.33±0.84 vs 0.51±0.57 min;  P =0.004). The onset of block was also faster in the B-D group than B-F group (98.27±35.95 vs 110.45±37.69 seconds;  P =0.036). The two groups did not show significant differences in hemodynamic changes and other variables ( P >0.05).
Conclusion


Compared with fentanyl, it seems that adding 5 μg dexmedetomidine to bupivacaine has a better effect on postoperative pain management in cesarean section under spinal anesthesia.",2020,The score of pain intensity during recovery time in the B-D group was significantly lower than that of B-F group (0.33±0.84 vs 0.51±0.57 min;  P =0.004).,"['Cesarean Section', '110 pregnant women with ASA I and II and gestational age ≥37 weeks who were candidates for elective cesarean section', 'cesarean section', 'cesarean section under spinal anesthesia']","['bupivacaine', 'Intrathecal Bupivacaine', 'fentanyl', 'Fentanyl vs Dexmedetomidine', 'bupivacaine (0.5%) + 5 μg dexmedetomidine', 'dexmedetomidine', 'bupivacaine (0.5%) + 25 μg fentanyl, intrathecally']","['score of pain intensity during recovery time', 'postoperative pain management', 'onset of block', 'onset of block, duration of analgesia, the score of pain intensity, hemodynamic changes, Apgar scores, and any adverse events', 'hemodynamic changes', 'Duration of analgesia']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",110.0,0.20687,The score of pain intensity during recovery time in the B-D group was significantly lower than that of B-F group (0.33±0.84 vs 0.51±0.57 min;  P =0.004).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Khosravi', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Jarineshin', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}]",Journal of pain research,['10.2147/JPR.S265161']
1926,33116795,Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study.,"Purpose


We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B 12 , vs a combination of vitamins B 1 , B 6 , and B 12 .
Patients and Methods


Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B 12  and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland-Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively).
Results


Seventy-five (24%) and 105 (33%) subjects ( P =0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs ( P =0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A ( P <0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant ( P <0.0001) in both groups, with Group A showing greater reduction at Visit 2 ( P <0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects.
Conclusion


Treatment with nucleotides+B 12  was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B 12  group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60.",2020,"VAS score reduction after 30 and 60 days of treatment was statistically significant ( P <0.0001) in both groups, with Group A showing greater reduction at Visit 2 ( P <0.0001).",['Low Back Pain'],"['Vitamin B12 vs B-Complex Vitamins', 'nucleotides, uridine (UTP), cytidine (CMP) and vitamin B 12 , vs a combination of vitamins B 1 , B 6 , and B 12 ', 'nucleotides+B 12  and Group B (n=317) receiving B vitamins']","['number of total AEs', 'percentage of subjects in each group presenting adverse events (AEs', 'visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland-Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD', 'RMQ score improvement ≥5 points', 'VAS score reduction', 'FFD improvement ≥3 cm', 'Pain intensity (VAS) reduction', 'efficacy measures RMQ and FFD']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0041984', 'cui_str': 'Uridine'}, {'cui': 'C0010715', 'cui_str': 'Cytidine'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231626', 'cui_str': 'Finger to floor distance'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0694188,"VAS score reduction after 30 and 60 days of treatment was statistically significant ( P <0.0001) in both groups, with Group A showing greater reduction at Visit 2 ( P <0.0001).","[{'ForeName': 'Marco Antonio Naslausky', 'Initials': 'MAN', 'LastName': 'Mibielli', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}, {'ForeName': 'Carlos Pereira', 'Initials': 'CP', 'LastName': 'Nunes', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Goldberg', 'Affiliation': 'Instituto De Pós-Graduação Médica Carlos Chagas (ICC), Rio De Janeiro, Brazil.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Buchman', 'Affiliation': 'UERJ Medical School, Rio De Janeiro, Brazil.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil.'}, {'ForeName': 'Spyros G E', 'Initials': 'SGE', 'LastName': 'Mezitis', 'Affiliation': 'New York-Presbyterian Hospital/Weill-Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Wajnzstajn', 'Affiliation': 'Neurology Department, UConn Health, Farmington, CT, USA.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Kaufman', 'Affiliation': 'Instituto De Pós-Graduação Médica Carlos Chagas (ICC), Rio De Janeiro, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Nigri', 'Affiliation': 'Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Cytrynbaum', 'Affiliation': 'Instituto De Pós-Graduação Médica Carlos Chagas (ICC), Rio De Janeiro, Brazil.'}, {'ForeName': 'Karin Soares', 'Initials': 'KS', 'LastName': 'Cunha', 'Affiliation': 'Pathology Department, Universidade Federal Fluminense (UFF) Medical School, Niterói, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil.'}, {'ForeName': 'Stephanie Wrobel', 'Initials': 'SW', 'LastName': 'Goldberg', 'Affiliation': 'Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Natália Carvalho', 'Initials': 'NC', 'LastName': 'Platenik', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Rzetelna', 'Affiliation': 'Santa Casa Da Misericórdia Do Rio De Janeiro, Rio De Janeiro, Brazil.'}, {'ForeName': 'Daniel Bertoluci', 'Initials': 'DB', 'LastName': 'Futuro', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}, {'ForeName': 'Adenilson de Souza', 'Initials': 'AS', 'LastName': 'Da Fonseca', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Geller', 'Affiliation': 'UNIFESO Medical School, Teresópolis, Brazil.'}]",Journal of pain research,['10.2147/JPR.S277024']
1927,33118956,Relationship Between Patient Engagement and Depressive Symptoms Among People Living With HIV in a Mobile Health Intervention: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Associations between higher levels of patient engagement and better health outcomes have been found in face-to-face interventions; studies on such associations with mobile health (mHealth) interventions have been limited and the results are inconclusive.
OBJECTIVE


The objective of this study is to investigate the relationship between patient engagement in an mHealth intervention and depressive symptoms using repeated measures of both patient engagement and patient outcomes at 4 time points.
METHODS


Data were drawn from a randomized controlled trial (RCT) of an mHealth intervention aimed at reducing depressive symptoms among people living with HIV and elevated depressive symptoms. We examined the association between patient engagement and depressive symptoms in the intervention group (n=150) where participants received an adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app. Depressive symptoms were repeatedly measured using the Patient Health Questionnaire (PHQ-9) at baseline and 1 month, 2 months, and 3 months. Patient engagement was correspondingly measured by the completion rate, frequency of items completed, and time spent on the program at 1 month, 2 months, and 3 months. Latent growth curve models (LGCMs) were used to explore the relationship between patient engagement and depressive symptoms at multiple time points in the intervention.
RESULTS


The mean PHQ-9 scores were 10.2 (SD 4.5), 7.7 (SD 4.8), 6.5 (SD 4.7), and 6.7 (SD 4.1) at baseline, 1 month, 2 months, and 3 months, respectively. The mean completion rates were 50.6% (SD 31.8%), 51.5% (SD 32.2%), and 50.8% (SD 33.7%) at 1, 2, and 3 months, respectively; the average frequencies of items completed were 18.0 (SD 14.6), 32.6 (SD 24.8), and 47.5 (SD 37.2) at 1, 2, and 3 months, respectively, and the mean times spent on the program were 32.7 (SD 66.7), 65.4 (SD 120.8), and 96.4 (SD 180.4) minutes at 1, 2, and 3 months, respectively. LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months. Although not significant, similar trends were found in the abovementioned relationships at 1 and 2 months. There was no significant relationship between time spent on the program and depressive symptoms.
CONCLUSIONS


This study revealed a positive association between patient engagement and health outcomes at 3 months of an mHealth intervention using LGCMs and repeated measures data. The results underscore the importance of improving patient engagement in mHealth interventions to improve patient-centered health outcomes.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://tinyurl.com/yxb64mef.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-018-5693-1.",2020,"LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months.","['people living with HIV and elevated depressive symptoms', 'People Living With HIV in a Mobile Health Intervention']","['adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app', 'mHealth intervention']","['time spent on the program and depressive symptoms', 'Patient Health Questionnaire (PHQ-9', 'mean times spent on the program', 'completion rate, frequency of items completed, and time spent', 'depressive symptoms', 'higher completion rate', 'Depressive symptoms', 'mean PHQ-9 scores', 'mean completion rates']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.109046,"LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center of Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Peilian', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, University of Macau, Macau, China.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Monroe-Wise', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rainbow Tin Hung', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong, China.'}]",JMIR mHealth and uHealth,['10.2196/20847']
1928,33118957,Virtual Reality-Based Treatment for Military Members and Veterans With Combat-Related Posttraumatic Stress Disorder: Protocol for a Multimodular Motion-Assisted Memory Desensitization and Reconsolidation Randomized Controlled Trial.,"BACKGROUND


Military members are at elevated risk of operational stress injuries, including posttraumatic stress disorder (PTSD) and moral injury. Although psychotherapy can reduce symptoms, some military members may experience treatment-resistant PTSD. Multimodular motion-assisted memory desensitization and reconsolidation (3MDR) has been introduced as a virtual reality (VR) intervention for military members with PTSD related to military service. The 3MDR intervention incorporates exposure therapy, psychotherapy, eye movement desensitization and reconsolidation, VR, supportive counselling, and treadmill walking.
OBJECTIVE


The objective of this study is to investigate whether 3MDR reduces PTSD symptoms among military members with combat-related treatment-resistant PTSD (TR-PTSD); examine the technology acceptance and usability of the Computer Assisted Rehabilitation ENvironment (CAREN) and 3MDR interventions by Canadian Armed Forces service members (CAF-SMs), veterans, 3MDR clinicians, and operators; and evaluate the impact on clinicians and operators of delivering 3MDR.
METHODS


This is a mixed-methods waitlist controlled crossover design randomized controlled trial. Participants include both CAF-SMs and veterans (N=40) aged 18-60 years with combat-related TR-PTSD (unsuccessful experience of at least 2 evidence-based trauma treatments). Participants will also include clinicians and operators (N=12) who have been trained in 3MDR and subsequently utilized this intervention with patients. CAF-SMs and veterans will receive 6 weekly 90-minute 3MDR sessions. Quantitative and qualitative data will be collected at baseline and at 1, 3, and 6 months postintervention. Quantitative data collection will include multiomic biomarkers (ie, blood and salivary proteomic and genomic profiles of neuroendocrine, immune-inflammatory mediators, and microRNA), eye tracking, electroencephalography, and physiological data. Data from outcome measures will capture self-reported symptoms of PTSD, moral injury, resilience, and technology acceptance and usability. Qualitative data will be collected from audiovisual recordings of 3MDR sessions and semistructured interviews. Data analysis will include univariate and multivariate approaches, and thematic analysis of treatment sessions and interviews. Machine learning analysis will be included to develop models for the prediction of diagnosis, symptom severity, and treatment outcomes.
RESULTS


This study commenced in April 2019 and is planned to conclude in April 2021. Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
CONCLUSIONS


The goal of this study is to utilize qualitative and quantitative primary and secondary outcomes to provide evidence for the effectiveness and feasibility of 3MDR for treating CAF-SMs and veterans with combat-related TR-PTSD. The results will inform a full-scale clinical trial and stimulate development and adaptation of the protocol to mobile VR apps in supervised clinical settings. This study will add to knowledge of the clinical effectiveness of 3MDR, and provide the first comprehensive analysis of biomarkers, technology acceptance and usability, moral injury, resilience, and the experience of clinicians and operators delivering 3MDR.
TRIAL REGISTRATION


ISRCTN Registry 11264368; http://www.isrctn.com/ISRCTN11264368.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20620.",2020,"Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
","['Participants include both CAF-SMs and veterans (N=40) aged 18-60 years with combat-related TR-PTSD (unsuccessful experience of at least 2 evidence-based trauma treatments', 'military members with PTSD related to military service', 'Military Members and Veterans With Combat-Related Posttraumatic Stress Disorder', 'military members with combat-related treatment-resistant PTSD (TR-PTSD', 'Participants will also include clinicians and operators (N=12) who have been trained in 3MDR and subsequently utilized this intervention with patients', 'veterans with combat-related TR-PTSD']","['Virtual Reality-Based Treatment', '3MDR', 'psychotherapy', '3MDR intervention', 'Multimodular motion-assisted memory desensitization and reconsolidation (3MDR', 'Computer Assisted Rehabilitation ENvironment (CAREN) and 3MDR interventions']","['capture self-reported symptoms of PTSD, moral injury, resilience, and technology acceptance and usability']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3714797', 'cui_str': 'Military service'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4505439', 'cui_str': 'Moral Injury'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0757549,"Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
","[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Smith-MacDonald', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Miguel-Cruz', 'Affiliation': 'Department of Occupational Therapy, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pike', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': ""ARQ Centrum'45, Diemen, Netherlands.""}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Lentz', 'Affiliation': 'School of Health Studies, Western University, London, ON, Canada.'}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Shiu', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tang', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sawalha', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Greenshaw', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Rhind', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Toronto, ON, Canada.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Norbash', 'Affiliation': 'Canadian Forces Health Services, Department of National Defense, Edmonton, AB, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jetly', 'Affiliation': 'Department of Mental Health, Canadian Forces Health Services, Department of National Defense, Ottawa, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Brémault-Phillips', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/20620']
1929,33118959,App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.,"BACKGROUND


Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all.
OBJECTIVE


This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone.
METHODS


The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020.
RESULTS


The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022.
CONCLUSIONS


This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20308.",2020,selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain.,['People With Low Back Pain'],"['usual care with usual care alone', 'selfBACK']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],[],,0.135628,selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain.,"[{'ForeName': 'Charlotte Diana Nørregaard', 'Initials': 'CDN', 'LastName': 'Rasmussen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Malene Jagd', 'Initials': 'MJ', 'LastName': 'Svendsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wood', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Barbara I', 'Initials': 'BI', 'LastName': 'Nicholl', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Louise Fleng', 'Initials': 'LF', 'LastName': 'Sandal', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Denmark, Odense M, Denmark.'}, {'ForeName': 'Paul Jarle', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Denmark, Odense M, Denmark.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Bach', 'Affiliation': 'Department of Computer Science, Faculty of Information Technology and Electrical Engineering, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Mette Jensen', 'Initials': 'MJ', 'LastName': 'Stochkendahl', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}]",JMIR research protocols,['10.2196/20308']
1930,33119010,"Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100 in patients with chronic heart failure: a randomized, triple-blind, controlled trial.","BACKGROUND AND AIMS


Nowadays, the potential beneficial effects of probiotic yogurt as a functional food has raised much interest. Thus, the aim of this study was to compare the probiotic yogurt and ordinary yogurt consumption on some indices in patients with chronic heart failure (CHF).
METHODS AND RESULTS


In this randomized, triple-blind clinical trial, 90 patients with CHF were randomly allocated into two groups to take either probiotic yogurt or ordinary yogurt for 10 weeks. The serum levels of pentraxin3 (PTX3), N-terminal pro-brain natriuretic peptide (NT-proBNP), oxidized low density lipoprotein (oxLDL), and apolipoprotein B100 (ApoB100) were measured at the baseline and at the end of week 10. P-Value <0.05 was defined as statistically significant. Final analyses were performed on 78 patients. The levels of PTX3 and oxLDL in both the groups decreased significantly after 10 weeks, and these reductions were greater in the probiotic group, where the difference between the groups was statistically significant for oxLDL (P-value: 0.051, adjusted P-value: 0.010) but not significant for PTX3 (P-value: 0.956, adjusted P-value: 0.236). The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306). ApoB100 significantly decreased in the control group compared to the probiotic group and the difference between the groups was significant at first but was not significant after adjusting for the confounders (P-value: 0.004, adjusted P-value: 0.280).
CONCLUSION


The serum oxLDL significantly reduced due to probiotic yogurt consumption after 10 weeks compared to ordinary yogurt; thus, it may be useful for improving the oxidative status of CHF patients. The clinical trial registry number is IRCT20091114002709N48 (https://www.irct.ir/IRCT20091114002709N48, registered 12 March 2018).",2020,"The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306).","['patients with chronic heart failure', 'patients with chronic heart failure (CHF', '90 patients with CHF']","['oxLDL', 'probiotic yogurt or ordinary yogurt', 'probiotic yogurt and ordinary yogurt consumption']","['serum levels of pentraxin3 (PTX3), N-terminal pro-brain natriuretic peptide (NT-proBNP), oxidized low density lipoprotein (oxLDL), and apolipoprotein B100 (ApoB100', 'serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100', 'levels of PTX3 and oxLDL', 'serum NT-proBNP levels', 'ApoB100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}]",90.0,0.0292987,"The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306).","[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Pourrajab', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. shidfar.f@iums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Naderi', 'Affiliation': 'Rajaie Cardiovascular, Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mofid', 'Affiliation': 'Department of food science and technology, Faculty of nutrition and food technology, National nutritional and food technology research institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hajahmadi', 'Affiliation': 'Department of Cardiology, Rasoul Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dehnad', 'Affiliation': 'Center for Educational Research in Medical Sciences (CERMS), Department of Medical Education, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. shidfar.f@iums.ac.ir.'}]",Food & function,['10.1039/d0fo01014f']
1931,33119047,Effect of Vitamin D and ω-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial.,"Importance


Observational studies suggest that higher intake or blood levels of vitamin D and marine ω-3 fatty acids may be associated with lower risks of age-related macular degeneration (AMD). However, evidence from randomized trials is limited.
Objective


To evaluate whether daily supplementation with vitamin D3, marine ω-3 fatty acids, or both prevents the development or progression of AMD.
Design, Setting, and Participants


This was a prespecified ancillary study of the Vitamin D and Omega-3 Trial (VITAL), a nationwide, placebo-controlled, 2 × 2 factorial design randomized clinical trial of supplementation with vitamin D and marine ω-3 fatty acids for the primary prevention of cancer and cardiovascular disease. Participants included 25 871 men and women in the US. Randomization was from November 2011 to March 2014, and study pill-taking ended as planned on December 31, 2017.
Interventions


Vitamin D3 (cholecalciferol), 2000 IU per day, and marine ω-3 fatty acids, 1 g per day.
Main Outcomes and Measures


The primary end point was total AMD events, a composite of incident cases of AMD plus cases of progression to advanced AMD among participants with AMD at baseline, based on self-report confirmed by medical record review. Analyses were conducted using the intention-to-treat population.
Results


In total, 25 871 participants with a mean (SD) age of 67.1 (7.0) years were included in the trial. Of them, 50.6% were women, 71.3% were self-declared non-Hispanic White participants, and 20.2% were Black participants. During a median (range) of 5.3 (3.8-6.1) years of treatment and follow-up, 324 participants experienced an AMD event (285 incident AMD and 39 progression to advanced AMD). For vitamin D3, there were 163 events in the treated group and 161 in the placebo group (hazard ratio [HR], 1.02; 95% CI, 0.82-1.27). For ω-3 fatty acids, there were 157 events in the treated group and 167 in the placebo group (HR, 0.94; 95% CI, 0.76-1.17). In analyses of individual components for the primary end point, HRs comparing vitamin D3 groups were 1.09 (95% CI, 0.86-1.37) for incident AMD and 0.63 (95% CI, 0.33-1.21) for AMD progression. For ω-3 fatty acids, HRs were 0.93 (95% CI, 0.73-1.17) for incident AMD and 1.05 (95% CI, 0.56-1.97) for AMD progression.
Conclusion and Relevance


Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
Trial Registration


ClinicalTrials.gov Identifier: NCT01782352.",2020,"Conclusion and Relevance


Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
","['Participants included 25\u202f871 men and women in the US', 'Of them, 50.6% were women, 71.3% were self-declared non-Hispanic White participants, and 20.2% were Black participants', 'In total, 25\u202f871 participants with a mean (SD) age of 67.1 (7.0) years were included in the trial']","['supplementation with vitamin D and marine ω-3 fatty acids', 'placebo', 'Vitamin D and Omega-3 Trial (VITAL', 'Vitamin D and ω-3 Fatty Acid Supplementation', 'Vitamin D3 (cholecalciferol', 'vitamin D3, marine ω-3 fatty acids']","['total AMD events, a composite of incident cases of AMD plus cases of progression to advanced AMD', 'Risk of Age-Related Macular Degeneration', 'AMD incidence or progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",25871.0,0.55341,"Conclusion and Relevance


Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Christen', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Chunying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Margarette', 'Initials': 'M', 'LastName': 'Haubourg', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Schaumberg', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.4409']
1932,33119048,Effect of Vocimagene Amiretrorepvec in Combination With Flucytosine vs Standard of Care on Survival Following Tumor Resection in Patients With Recurrent High-Grade Glioma: A Randomized Clinical Trial.,"Importance


New treatments are needed to improve the prognosis of patients with recurrent high-grade glioma.
Objective


To compare overall survival for patients receiving tumor resection followed by vocimagene amiretrorepvec (Toca 511) with flucytosine (Toca FC) vs standard of care (SOC).
Design, Setting, and Participants


A randomized, open-label phase 2/3 trial (TOCA 5) in 58 centers in the US, Canada, Israel, and South Korea, comparing posttumor resection treatment with Toca 511 followed by Toca FC vs a defined single choice of approved (SOC) therapies was conducted from November 30, 2015, to December 20, 2019. Patients received tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma.
Interventions


Patients were randomized 1:1 to receive Toca 511/FC (n = 201) or SOC control (n = 202). For the Toca 511/FC group, patients received Toca 511 injected into the resection cavity wall at the time of surgery, followed by cycles of oral Toca FC 6 weeks after surgery. For the SOC control group, patients received investigators' choice of single therapy: lomustine, temozolomide, or bevacizumab.
Main Outcomes and Measures


The primary outcome was overall survival (OS) in time from randomization date to death due to any cause. Secondary outcomes reported in this study included safety, durable response rate (DRR), duration of DRR, durable clinical benefit rate, OS and DRR by IDH1 variant status, and 12-month OS.
Results


All 403 randomized patients (median [SD] age: 56 [11.46] years; 62.5% [252] men) were included in the efficacy analysis, and 400 patients were included in the safety analysis (3 patients on the SOC group did not receive resection). Final analysis included 271 deaths (141 deaths in the Toca 511/FC group and 130 deaths in the SOC control group). The median follow-up was 22.8 months. The median OS was 11.10 months for the Toca 511/FC group and 12.22 months for the control group (hazard ratio, 1.06; 95% CI 0.83, 1.35; P = .62). The secondary end points did not demonstrate statistically significant differences. The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
Conclusions and Relevance


Among patients who underwent tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma, administration of Toca 511 and Toca FC, compared with SOC, did not improve overall survival or other efficacy end points.
Trial Registration


ClinicalTrials.gov Identifier: NCT02414165.",2020,"The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
","['271 deaths (141 deaths in the Toca 511/FC group and 130 deaths in the SOC control group', 'patients who underwent tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma', 'With Recurrent High-Grade Glioma', 'Patients', 'patients with recurrent high-grade glioma', '58 centers in the US, Canada, Israel, and South Korea, comparing posttumor resection treatment with Toca 511 followed by Toca FC vs a defined single choice of approved (SOC) therapies was conducted from November 30, 2015, to December 20, 2019', 'All 403 randomized patients (median [SD] age: 56 [11.46] years; 62.5% [252] men) were included in the efficacy analysis, and 400 patients were included in the safety analysis (3 patients on the SOC group did not receive resection', 'patients receiving tumor resection followed by vocimagene amiretrorepvec (Toca 511) with']","['Flucytosine vs Standard of Care', 'flucytosine (Toca FC) vs standard of care (SOC', 'SOC control', 'single therapy: lomustine, temozolomide, or bevacizumab', 'Toca 511/FC']","['overall survival (OS', 'median OS', 'safety, durable response rate (DRR), duration of DRR, durable clinical benefit rate, OS and DRR by', 'rates of adverse events', 'overall survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4722370', 'cui_str': 'Toca 511'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0016278', 'cui_str': 'Flucytosine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",403.0,0.0964429,"The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Petrecca', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Butowski', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Salacz', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Sunnybrook Research Institute, Sunnybrook Hospital, Toronto, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Damek', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bota', 'Affiliation': 'University of California, Irvine, Irvine, California.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Bettegowda', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jay-Jiguang', 'Initials': 'JJ', 'LastName': 'Zhu', 'Affiliation': 'University of Texas Health Science Center, Houston, Texas.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Iwamoto', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Placantonakis', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Elder', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kaptain', 'Affiliation': 'John Theurer Cancer Center, Hackensack University, Hackensack, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cachia', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Moshel', 'Affiliation': 'Overlook Medical Center, Summit, New Jersey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brem', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piccioni', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Landolfi', 'Affiliation': 'JFK Medical Center, Edison, New Jersey.'}, {'ForeName': 'Clark C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Gruber', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Aliz', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hogan', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Accomando', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ostertag', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Tiffany T', 'Initials': 'TT', 'LastName': 'Montellano', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Thian', 'Initials': 'T', 'LastName': 'Kheoh', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Fairooz', 'Initials': 'F', 'LastName': 'Kabbinavar', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Cleveland Clinic Foundation, Moffitt Cancer Center, Tampa, Florida.'}]",JAMA oncology,['10.1001/jamaoncol.2020.3161']
1933,33112544,Three-Dimensional (3D) Laparoscopy Versus Two-Dimensional (2D) Laparoscopy: A Single-Surgeon Prospective Randomized Comparative Study.,"BACKGROUND


Visual information is crucial for performing laparoscopic surgery. While surgeons lose depth perception and spatial orientation in conventional 2D laparoscopy, the 4th generation 3D system gives a better depth perception.
OBJECTIVE


In this sstudy, we aimed to investigate the feasibility, safety, and short-term efficacy of 4th generation 3D-HD visualization technology applied in laparoscopic colon cancer surgery.
METHODS


One hundred and twenty patients with colon adenocarcinoma were recruited in this study. Patients were randomized on the day of surgery by a random computer-generated allocation list to undergo either a 3D-HD display or 2D-HD imaging system laparoscopic colon cancer surgery. In total, 60 patients underwent laparoscopic colon resection by 3D-HD laparoscope (3D group) and 60 patients underwent 2D-HD laparoscope (2D group). After the insertion of the access ports, both surgical procedures were divided in component tasks, and the execution times were compared. Data analysis was done using SPSS (version 15.0). Quantitative and qualitative variables were compared applying Student t test and Pearson's chi-square test.
RESULTS


Two groups were homogenous in terms of demographic data. Operation time was significantly shorter for the 3D group than for the 2D group (123.2±34.2 min vs. 142.2±23.5 min, P=0.018). There was no statistically significant difference between two groups in terms of intraoperative blood loss, the number of retrieved lymph nodes, postoperative recovery, and postoperative complications (P>0.05).
CONCLUSION


The 4th generation 3D-HD vision system reduced the operating time compared to 2D-HD vision system. It seems that use of the 3D-HD technology can significantly enhance the possibility of achieving better intraoperative results. <br />.",2020,"There was no statistically significant difference between two groups in terms of intraoperative blood loss, the number of retrieved lymph nodes, postoperative recovery, and postoperative complications (P>0.05).
","['60 patients underwent', 'One hundred and twenty patients with colon adenocarcinoma']","['4th generation 3D-HD visualization technology', 'random computer-generated allocation list to undergo either a 3D-HD display or 2D-HD imaging system laparoscopic colon cancer surgery', 'Three-Dimensional (3D) Laparoscopy Versus Two-Dimensional (2D) Laparoscopy', 'laparoscopic colon resection by 3D-HD laparoscope (3D group) and 60 patients underwent 2D-HD laparoscope (2D group']","['intraoperative blood loss, the number of retrieved lymph nodes, postoperative recovery, and postoperative complications', 'Operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}]","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023036', 'cui_str': 'Laparoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.0508133,"There was no statistically significant difference between two groups in terms of intraoperative blood loss, the number of retrieved lymph nodes, postoperative recovery, and postoperative complications (P>0.05).
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.'}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Mei', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.10.2883']
1934,33112550,A Randomized Controlled Trial of Novel Treatment for Hemorrhagic Radiation Proctitis.,"BACKGROUND


Various methods have been used for treatment of hemorrhagic radiation proctitis (HRP) with variable results. Currently, the preferred treatment is formalin application or endoscopic therapy with argon plasma coagulation. Recently, a novel therapy with colonic water irrigation and oral antibiotics showed promising results and more effective compared to 4% formalin application for HRP. The study objective is to compare the effect of water irrigation and oral antibiotics versus 4% formalin application in improving per rectal bleeding due to HRP and related symptoms such as diarrhoea, tenesmus, stool frequency, stool urgency and endoscopic findings.
METHODS


We conducted a study on 34 patients with HRP and randomly assigned the patients to two treatment arm groups (n=17). The formalin group underwent 4% formalin dab and another session 4 weeks later. The irrigation group self-administered daily rectal irrigation at home for 8 weeks and consumed oral metronidazole and ciprofloxacin during the first one week. We measured the patients' symptoms and endoscopic findings before and after total of 8 weeks of treatment in both groups.
RESULTS


Our study showed that HRP patients had reduced per rectal bleeding (p = 0.003) in formalin group, whereas irrigation group showed reduced diarrhoea (p=0.018) and tenesmus (p=0.024) symptoms. The comparison between the two treatment arms showed that irrigation technique was better than formalin technique for tenesmus (p=0.043) symptom only.
CONCLUSION


This novel treatment showed benefit in treating HRP. It could be a new treatment option which is safe and conveniently self-administered at home or used as a combination with other therapies to improve the treatment outcome for HRP.<br />.",2020,"Our study showed that HRP patients had reduced per rectal bleeding (p = 0.003) in formalin group, whereas irrigation group showed reduced diarrhoea (p=0.018) and tenesmus (p=0.024) symptoms.","['34 patients with HRP and randomly assigned the patients to two treatment arm groups (n=17', 'Hemorrhagic Radiation Proctitis']","['metronidazole and ciprofloxacin', 'water irrigation and oral antibiotics versus 4% formalin application', 'irrigation group self-administered daily rectal irrigation', 'HRP']","['diarrhoea', 'diarrhoea, tenesmus, stool frequency, stool urgency and endoscopic findings', 'rectal bleeding', 'tenesmus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0590256', 'cui_str': 'Water 1000 MG/ML Irrigation Solution'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0193144', 'cui_str': 'Rectal irrigation'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}]",34.0,0.0360826,"Our study showed that HRP patients had reduced per rectal bleeding (p = 0.003) in formalin group, whereas irrigation group showed reduced diarrhoea (p=0.018) and tenesmus (p=0.024) symptoms.","[{'ForeName': 'Wei Chieng', 'Initials': 'WC', 'LastName': 'Pui', 'Affiliation': 'Department of Surgery, Sibu Hospital, Sarawak, Malaysia.'}, {'ForeName': 'Tiong How', 'Initials': 'TH', 'LastName': 'Chieng', 'Affiliation': 'Department of Surgery, Sibu Hospital, Sarawak, Malaysia.'}, {'ForeName': 'Sze Li', 'Initials': 'SL', 'LastName': 'Siow', 'Affiliation': 'Department of Surgery, Sarawak General Hospital(SGH), Sarawak, Malaysia.'}, {'ForeName': 'Nik Azim', 'Initials': 'NA', 'LastName': 'Nik Abdullah', 'Affiliation': 'Department of Surgery, Sarawak General Hospital(SGH), Sarawak, Malaysia.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sagap', 'Affiliation': 'Colorectal Unit, Department of Surgery, Universiti Kebangsaan Malaysia(UKM), Kuala Lumpur, Malaysia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.10.2927']
1935,33112655,Plasma brain-derived neurotrophic factor and dynamic cerebral autoregulation in acute response to glycemic control following breakfast in young men.,"We examined the acute impact of both low- and high-glycemic index (GI) breakfasts on plasma brain-derived neurotrophic factor (BDNF) and dynamic cerebral autoregulation (dCA) compared to breakfast omission. Ten healthy men (age 24 ± 1 yrs) performed three trials in a randomized crossover order; omission, Low- (GI = 40), and High-GI (GI = 71) breakfast conditions. Middle cerebral artery velocity (transcranial Doppler ultrasonography) and arterial pressure (finger photoplethysmography) were continuously measured for 5-mins prior to and 120-mins following breakfast consumption, to determine dCA using transfer function analysis. After these measurements of dCA, venous blood samples for the assessment of plasma BDNF were obtained. Moreover, blood glucose was measured before breakfast and every 30 mins thereafter. The area under the curve of 2-hours post-prandial blood glucose in the High-GI trial was higher than Low-GI trial (P < 0.01). The GI of the breakfast did not affect BDNF. In addition, both very low- (VLF) and low-frequencies (LF) transfer function phase or gains were not changed during the omission trial. In contrast, LF gain (High-GI P < 0.05) and normalized gain (Low-GI P < 0.05) were decreased by both GI trials, while a decrease in VLF phase was observed in only the High-GI trial (P < 0.05). These findings indicate that breakfast consumption augmented dCA in the LF range, but High-GI breakfast attenuated CBF regulation against slow change (i.e., the VLF range) in arterial pressure. Thus, we propose that breakfast and glycemic control may be an important strategy to optimize cerebrovascular health.",2020,"In contrast, LF gain (High-GI P < 0.05) and normalized gain (Low-GI P < 0.05) were decreased by both GI trials, while a decrease in VLF phase was observed in only the High-GI trial (P < 0.05).","['Ten healthy men (age 24 ± 1 yrs', 'young men']","['omission, Low- (GI = 40), and High-GI (GI = 71) breakfast conditions', 'low- and high-glycemic index (GI) breakfasts']","['blood glucose', 'VLF) and low-frequencies (LF) transfer function phase or gains', 'normalized gain', 'LF gain', 'VLF phase', 'area under the curve of 2-hours post-prandial blood glucose', 'Middle cerebral artery velocity (transcranial Doppler ultrasonography) and arterial pressure (finger photoplethysmography', 'plasma brain-derived neurotrophic factor (BDNF) and dynamic cerebral autoregulation (dCA']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}]",10.0,0.0410828,"In contrast, LF gain (High-GI P < 0.05) and normalized gain (Low-GI P < 0.05) were decreased by both GI trials, while a decrease in VLF phase was observed in only the High-GI trial (P < 0.05).","[{'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Tsukamoto', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, United Kingdom; Faculty of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Ishibashi', 'Affiliation': 'Japan Institute of Sports Science, Tokyo, Japan; Department of Life Sciences, The University of Tokyo, Tokyo.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Marley', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, United Kingdom.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shinohara', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, Tokyo, Japan.'}, {'ForeName': 'Damian M', 'Initials': 'DM', 'LastName': 'Bailey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, United Kingdom.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Shigehiko', 'Initials': 'S', 'LastName': 'Ogoh', 'Affiliation': 'Department of Biomedical Engineering, Toyo University, Saitama, Japan.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00059.2020']
1936,33112697,Double blind disruption of right inferior frontal cortex with TMS reduces right frontal beta power for action-stopping.,"Stopping actions depends on the integrity of the right inferior frontal gyrus (rIFG). Electrocorticography from the rIFG shows an increase in beta power during action-stopping. Scalp EEG shows a similar right frontal beta increase, but it is unknown if this beta modulation relates to the underlying rIFG network. Demonstrating a causal relationship between the rIFG and right frontal beta in EEG during action-stopping is important for putting this electrophysiological marker on a firmer footing. In a double-blind study with a true sham coil, we used fMRI-guided 1Hz repetitive transcranial magnetic stimulation (rTMS) to disrupt the rIFG, and to test if this eroded right frontal beta and impaired action-stopping. We found that rTMS selectively slowed stop signal reaction time (SSRT) (no effect on Go), and reduced right frontal beta (no effect on sensorimotor mu/beta related to Go); it also reduced the variance of a single trial muscle marker of stopping. Surprisingly, sham also slowed SSRTs and reduced beta. Part of this effect, however, resulted from carry-over of real stimulation in participants who received real first. A post-hoc between-group comparison of those participants who received real first compared to those who received sham first showed that real stimulation eroded beta significantly more. Thus, real rTMS uniquely affected metrics of stopping in the muscle and resulted in a stronger erosion of beta. We argue that this causal test validates right frontal beta as a functional marker of action-stopping.",2020,Stopping actions depends on the integrity of the right inferior frontal gyrus (rIFG).,[],"['rTMS', 'TMS', 'Electrocorticography', 'fMRI-guided 1Hz repetitive transcranial magnetic stimulation (rTMS']","['reduced right frontal beta', 'stop signal reaction time (SSRT', 'beta power']",[],"[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0995825,Stopping actions depends on the integrity of the right inferior frontal gyrus (rIFG).,"[{'ForeName': 'Kelsey K', 'Initials': 'KK', 'LastName': 'Sundby', 'Affiliation': 'Psychology, University of California, San Diego, United States.'}, {'ForeName': 'Sumitash', 'Initials': 'S', 'LastName': 'Jana', 'Affiliation': 'Department of Psychology, University of California, Berkeley, United States.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Aron', 'Affiliation': 'Psychology, University of California, San Diego, United States.'}]",Journal of neurophysiology,['10.1152/jn.00459.2020']
1937,33112720,"The alliance mediates outcome in cognitive-behavioral therapy for social anxiety disorder, but not in attention bias modification.","Objective:  The aim of the current study was to examine changes in the therapeutic alliance and its role as a mediator of treatment outcome in cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) compared to attention bias modification (ABM).  Method:  Patients were randomized to 16-20 sessions of CBT (n = 33) or 8 sessions of ABM (n = 17). Patient-rated alliance and self-reported social anxiety were measured weekly and evaluator-rated social anxiety was measured monthly.  Results:  Early alliance predicted greater subsequent anxiety reduction in CBT but not in ABM. The alliance increased and weekly improvements in alliance predicted weekly contemporaneous and subsequent decreases in anxiety only in CBT. Decreases in anxiety did not predict subsequent improvements in alliance. Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM.  Conclusions:  The results highlight the importance of the alliance in CBT for SAD. Further studies should examine the role of alliance alongside additional mediators to better understand differential mechanisms in CBT and ABM.",2020,"Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM.  ",['social anxiety disorder (SAD'],"['CBT', 'ABM', 'cognitive behavioral therapy (CBT', 'cognitive-behavioral therapy']","['anxiety', 'social anxiety', 'subsequent anxiety reduction', 'Patient-rated alliance and self-reported social anxiety']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0198017,"Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM.  ","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': ''}, {'ForeName': 'Asher Y', 'Initials': 'AY', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Ramat Gan, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Ramat Gan, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Ramat Gan, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Ramat Gan, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Ramat Gan, Israel.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1836423']
1938,33112722,Post flywheel squat vs. flywheel deadlift potentiation of lower limb isokinetic peak torques in male athletes.,"The present study investigated the post-activation performance enhancement (PAPE) of isokinetic quadriceps and hamstrings torque after flywheel (FW)-squat vs. FW-deadlift in comparison to a control condition. Fifteen male athletes were enrolled in this randomised, crossover study. Each protocol consisted of 3 sets of 6 repetitions, with an inertial load of 0.029 kg . m 2 . Isokinetic quadriceps (knee extension) and hamstrings (knee flexion) concentric peak torque (60º/s) and hamstring eccentric peak torque (-60º/s) were measured 5 min after experimental or control conditions. A significant condition (PAPE) effect was reported ( f  = 4.067, p = 0.008) for isokinetic hamstrings eccentric peak torque following FW-squat and FW-deadlift, but no significant differences were found for quadriceps and hamstrings concentric peak torques. The significant difference averaged 14 Nm between FW-squat vs. control (95% CI: 2, 28;  d  = 0.75,  moderate ; p = 0.033), and 13 Nm between FW-deadlift vs. control (95% CI: 1, 25;  d  = 0.68,  moderate ; p = 0.038). This study reported that both FW-squat and FW-deadlift exercises are equivalently capable of generating PAPE of isokinetic hamstrings eccentric torque. Practitioners may use these findings to inform strength and power development during complex training sessions consisting of flywheel-based exercises prior to a sport-specific task.",2020,"= 4.067, p = 0.008) for isokinetic hamstrings eccentric peak torque following FW-squat and FW-deadlift, but no significant differences were found for quadriceps and hamstrings concentric peak torques.","['Fifteen male athletes', 'male athletes']","['FW-squat and FW-deadlift exercises', 'isokinetic quadriceps and hamstrings torque after flywheel (FW)-squat vs. FW-deadlift', 'Post flywheel squat vs. flywheel deadlift potentiation']","['Isokinetic quadriceps (knee extension) and hamstrings (knee flexion) concentric peak torque (60º/s) and hamstring eccentric peak torque (-60º/s', 'isokinetic hamstrings eccentric peak torque following FW-squat and FW-deadlift', 'limb isokinetic peak torques', 'condition (PAPE) effect', 'quadriceps and hamstrings concentric peak torques']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",15.0,0.0255884,"= 4.067, p = 0.008) for isokinetic hamstrings eccentric peak torque following FW-squat and FW-deadlift, but no significant differences were found for quadriceps and hamstrings concentric peak torques.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Beato', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk , Ipswich, UK.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'de Keijzer', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk , Ipswich, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk , Ipswich, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk , Ipswich, UK.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'La Spina', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan , Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan , Milan, Italy.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'McErlain-Naylor', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk , Ipswich, UK.'}]",Sports biomechanics,['10.1080/14763141.2020.1810750']
1939,33112812,"Metformin decreases miR-122, miR-223 and miR-29a in women with polycystic ovary syndrome.","Metformin is associated with increased insulin sensitivity, whereas oral contraceptive pills (OCP) could increase the risk for type 2 diabetes (T2D) in women with polycystic ovary syndrome (PCOS). Certain microRNAs (miRNAs) might serve as biomarkers for the risk of T2D. The aim of this study was to investigate changes in circulating miRNA levels during treatment with metformin and OCP in women with PCOS. Sixty-five women with PCOS according to Rotterdam criteria were randomized to metformin (2g/d), metformin+OCP (150 mg desogestrel + 30 µg ethinylestradiol) or OCP alone for 12 months. Serum miRNA analysis was performed with individual RT-qPCR or Taqman Low Density Array cards of 22 selected miRNAs previously related to PCOS, glucose and/or lipid metabolism. MiR-122 and miR-29a levels were decreased after treatment with metformin compared with metformin+OCP and OCP group: miR-122: log2 difference -0.7 (p= 0.01) and -0.7 (p= 0.02), miR-29a: log2 difference -0.5 (p= 0.01) and -0.4 (p= 0.04), while miR-223 levels were decreased in the metformin+OCP group after treatment: log2 difference -0.5 (p=0.02). During the treatment period, a significant weight loss was observed in the metformin group compared with the OCP group. In the OCP group, miRNA levels were unchanged during the treatment period. Levels of circulating miRNAs associated with lipid and glucose metabolism decreased during metformin treatment. Changes in miRNA levels in the metformin group could be explained by the simultaneous weight loss in the same group. These results support the notion that metformin treatment alone may be superior for metabolic health compared with OCP.",2020,"MiR-122 and miR-29a levels were decreased after treatment with metformin compared with metformin+OCP and OCP group: miR-122: log2 difference -0.7 (p= 0.01) and -0.7 (p= 0.02), miR-29a:","['women with polycystic ovary syndrome', 'Sixty-five women with PCOS according to Rotterdam criteria', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS']","['metformin+OCP and OCP', 'OCP', 'Metformin', 'desogestrel + 30 µg ethinylestradiol) or OCP', 'metformin', 'metformin and OCP', 'metformin+OCP', 'oral contraceptive pills (OCP']","['circulating miRNA levels', 'metabolic health', 'weight loss', 'miRNA levels', 'lipid and glucose metabolism', 'miR-223 levels', 'miR-122, miR-223 and miR-29a', 'simultaneous weight loss', 'MiR-122 and miR-29a levels', 'insulin sensitivity', 'miR-29a']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",65.0,0.0347651,"MiR-122 and miR-29a levels were decreased after treatment with metformin compared with metformin+OCP and OCP group: miR-122: log2 difference -0.7 (p= 0.01) and -0.7 (p= 0.02), miR-29a:","[{'ForeName': 'Pernille Bækgaard', 'Initials': 'PB', 'LastName': 'Udesen', 'Affiliation': 'P Udesen, The Fertility Clinic, Department of Gynecology and Obstetrics, Zealand University Hospital Koge, Koge, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Glintborg', 'Affiliation': 'D Glintborg, Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anja Elaine', 'Initials': 'AE', 'LastName': 'Sørensen', 'Affiliation': 'A Sørensen, Department of Science and Environment, Roskilde Universitet, Roskilde, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Svendsen', 'Affiliation': 'R Svendsen, Department of Science and Environment, Roskilde Universitet, Roskilde, Denmark.'}, {'ForeName': 'Nanna Louise Skov', 'Initials': 'NLS', 'LastName': 'Nielsen', 'Affiliation': 'N Nielsen, Department of Science and Environment, Roskilde Universitet, Roskilde, Denmark.'}, {'ForeName': 'Marie Louise Muff', 'Initials': 'MLM', 'LastName': 'Wissing', 'Affiliation': 'M Wissing, The fertility Clinic, Aleris Hamlet Hospital Group, Soborg, Denmark.'}, {'ForeName': 'Marianne Skovsager', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'M Andersen, Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne Lis Mikkelsen', 'Initials': 'ALM', 'LastName': 'Englund', 'Affiliation': 'A Englund, The Fertility Clinic, Department of Gynecology and Obstetrics, Zealand University Hospital Koge, Koge, Denmark.'}, {'ForeName': 'Louise Torp', 'Initials': 'LT', 'LastName': 'Dalgaard', 'Affiliation': 'L Dalgaard, Department of Science and Environment, Roskilde Universitet, Roskilde, Denmark.'}]",Endocrine connections,['10.1530/EC-20-0195']
1940,33112835,No effect of 10 weeks erythropoietin treatment on lipid oxidation in healthy men.,"Studies indicate that erythropoietin (EPO) has effect on lipid and energy metabolism; however, the impact of EPO on lipid oxidation in vivo has not been well documented. Here, we evaluate whether long-term erythropoiesis-stimulating agent (ESA) treatment affects the oxidation of plasma very low-density lipoprotein triglycerides (VLDL-TG) fatty acids (FA) , plasma free fatty acids (FFA) and non-plasma (residual) FA in healthy, young, sedentary men. Infusion of [1-14C]VLDL-TG and [9,10-3H]palmitate was used in combination with indirect calorimetry to assess resting lipid fuel utilization and kinetics, and resting energy expenditure (REE) before and after 10 weeks of ESA exposure compared with placebo. REE increased significantly during ESA compared with placebo (P=0.023, RM-ANOVA). Oxidation rates of VLDL-TG FA, FFA, and residual FA remained unchanged during ESA compared with placebo. The relative contribution of the lipid stores was greatest for FFA (47.1%) and the total lipid oxidation rate and was not significantly different between ESA and placebo treated subjects. We conclude that long-term ESA treatment of healthy young men increases REE but does not alter the oxidation rates of plasma and non-plasma FA sources.",2020,"REE increased significantly during ESA compared with placebo (P=0.023, RM-ANOVA).","['healthy, young, sedentary men', 'healthy men', 'healthy young men']","['erythropoietin treatment', 'erythropoietin (EPO', 'long-term erythropoiesis-stimulating agent (ESA', 'placebo', 'Infusion of [1-14C]VLDL-TG']","['Oxidation rates of VLDL-TG FA, FFA, and residual FA', 'oxidation of plasma very low-density lipoprotein triglycerides (VLDL-TG) fatty acids (FA) , plasma free fatty acids (FFA) and non-plasma (residual) FA', 'oxidation rates of plasma and non-plasma FA sources', 'lipid stores', 'total lipid oxidation rate', 'lipid oxidation', 'resting lipid fuel utilization and kinetics, and resting energy expenditure (REE', 'REE']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0065191', 'cui_str': 'Low density lipoprotein triglyceride'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0523744', 'cui_str': 'Lipids measurement'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.0692993,"REE increased significantly during ESA compared with placebo (P=0.023, RM-ANOVA).","[{'ForeName': 'Jeyanthini', 'Initials': 'J', 'LastName': 'Risikesan', 'Affiliation': 'J Risikesan, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, 8000, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Nellemann', 'Affiliation': 'B Nellemann, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'B Christensen, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'J Jørgensen, Department of Endocrinology and Diabetes, Aarhus University Hospital, Aarhus, 8000, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'S Nielsen, Aarhus, DK-8000, Denmark.'}]",Endocrine connections,['10.1530/EC-20-0305']
1941,33117419,Effects and mechanisms of glucose-insulin-potassium on post-procedural myocardial injury after percutaneous coronary intervention.,"Objective


To evaluate the effects and mechanisms of glucose-insulin-potassium (GIK) on post-procedural myocardial injury (PMI) after percutaneous coronary intervention (PCI).
Methods


A total of 200 non-diabetic patients with documented coronary heart disease (CHD) were divided into the Group GIK and Group G, with 100 patients in each group. Patients in Group G were given intravenous infusion of glucose solution 2 hours before PCI. As compared, patients in Group GIK were given GIK.
Results


Both post-procedural creatine phosphokinase isoenzyme MB (CK-MB; 62.1 ± 47.8  vs.  48.8 ± 52.6 U/L,  P  = 0.007) and cTnI (0.68 ± 0.83  vs.  0.19 ± 0.24 ng/mL,  P  < 0.001) in Group GIK were significantly higher than those in Group G. In Group G, 9.0% and 4.0% of patients had post-procedural increases in CK-MB 1-3 times and > 3 times, which were significantly lower than those in Group GIK (14.0% and 7.0%, respectively; all  P  values < 0.01); 13.0% and 7.0% of patients had post-procedural increases in cTnI 1-3 times and > 3 times, which were also significantly lower than those in Group GIK (21.0% and 13.0%, respectively; all  P  < 0.001). Pre-procedural (10.2 ± 4.5  vs.  5.1 ± 6.3,  P  < 0.001) and post-procedural rapid blood glucose (RBG) levels (8.9 ± 3.9  vs.  5.3 ± 5.6,  P  < 0.001) in Group G were higher than those in Group GIK. In adjusted logistic models, usage of GIK (compared with glucose solution) remained significantly and independently associated with higher risk of post-procedural increases in both CK-MB and cTnI levels > 3 times. Furthermore, pre-procedural RBG levels < 5.0mmol/L were significantly associated with higher risk of post-procedural increases in both CK-MB and cTnI levels.
Conclusions


In non-diabetic patients with CHD, the administration of GIK may increase the risk of PMI due to hypoglycemia induced by GIK.",2020,"Both post-procedural creatine phosphokinase isoenzyme MB (CK-MB; 62.1 ± 47.8  vs.  48.8 ± 52.6 U/L,  P  = 0.007) and cTnI (0.68 ± 0.83  vs.  0.19 ± 0.24 ng/mL,  P  < 0.001) in Group GIK were significantly higher than those in Group G.","['200 non-diabetic patients with documented coronary heart disease (CHD', 'post-procedural myocardial injury after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'glucose-insulin-potassium (GIK', 'intravenous infusion of glucose solution', 'glucose-insulin-potassium']","['post-procedural rapid blood glucose (RBG) levels', 'pre-procedural RBG levels', 'CK-MB']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}]",200.0,0.0266328,"Both post-procedural creatine phosphokinase isoenzyme MB (CK-MB; 62.1 ± 47.8  vs.  48.8 ± 52.6 U/L,  P  = 0.007) and cTnI (0.68 ± 0.83  vs.  0.19 ± 0.24 ng/mL,  P  < 0.001) in Group GIK were significantly higher than those in Group G.","[{'ForeName': 'Yi-Dan', 'Initials': 'YD', 'LastName': 'Hao', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Hao', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ying-Xin', 'Initials': 'YX', 'LastName': 'Zhao', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Zhou', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Yu-Yang', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'De-An', 'Initials': 'DA', 'LastName': 'Jia', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Hong-Ya', 'Initials': 'HY', 'LastName': 'Han', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Guo-Zhong', 'Initials': 'GZ', 'LastName': 'Pan', 'Affiliation': 'Dongzhimen Hospital Eastern Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhen-Feng', 'Initials': 'ZF', 'LastName': 'Guo', 'Affiliation': 'Benq Medical Center, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shi-Wei', 'Initials': 'SW', 'LastName': 'Yang', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}, {'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Zhou', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Disease, the Key Laboratory of Remodeling-related Cardiovascular Disease, Ministry of Education, Beijing, China.'}]",Journal of geriatric cardiology : JGC,['10.11909/j.issn.1671-5411.2020.09.004']
1942,33117454,Effects of dapagliflozin on serum and urinary uric acid levels in patients with type 2 diabetes: a prospective pilot trial.,"Background


We aimed to evaluate the effects of short-term therapy with dapagliflozin on serum uric acid (SUA) and urinary uric acid (UUA) levels in patients with type 2 diabetes.
Methods


In this prospective pilot trial, 8 patients with type 2 diabetes mellitus were assigned to the treatment group with dapagliflozin 10 mg once daily for one week, and 7 subjects with normal glucose tolerance were recruited into the control group. Data of anthropometric measurements, SUA, 24-h UUA, fractional excretion of UA (FEUA), serum lipid parameters and 3-h oral glucose tolerance test (OGTT) were collected in both treatment and control groups; all examinations were repeated after treatment. The area under the curve of glucose (AUC Glu ) was calculated to reflect the general glucose levels, while insulin resistance and islet β-cell function were reflected by indexes calculated according to the data obtained from the OGTT.
Results


The weight and serum lipid parameters showed no differences before and after treatment with dapagliflozin for one week. We found SUA levels decreased from 347.75 ± 7.75 μmol/L before treatment to 273.25 ± 43.18 μmol/L after treatment, with a statistically significant difference (P = 0.001) and was accompanied by a significant increase in FEUA from 0.009 to 0.029 (P = 0.035); there was a linear correlation between SUA and FEUA levels. Glucose control, insulin sensitivity and islet β-cell function were improved to a certain extent. We also found a positive correlation between the decrease in glucose levels and the improvement in islet β-cell function.
Conclusions


The SUA-lowering effect of dapagliflozin could be driven by increasing UA excretion within one week of treatment, and a certain degree of improvement in glucose levels and islet β-cell function were observed. Trial registration  ClinicalTrials.gov identifier, NCT04014192. Registered 12 July 2019, https://www.clinicaltrials.gov/ct2/show/NCT04014192:term=NCT04014192&draw=2&rank=1. Yes.",2020,The weight and serum lipid parameters showed no differences before and after treatment with dapagliflozin for one week.,"['patients with type 2 diabetes', '8 patients with type 2 diabetes mellitus', '7 subjects with normal glucose tolerance were recruited into the control group']",['dapagliflozin'],"['general glucose levels, while insulin resistance and islet β-cell function', 'area under the curve of glucose (AUC Glu ', 'glucose levels', 'UA excretion', 'glucose levels and islet β-cell function', 'serum uric acid (SUA) and urinary uric acid (UUA) levels', 'SUA levels', 'FEUA', 'serum and urinary uric acid levels', 'Glucose control, insulin sensitivity and islet β-cell function', 'weight and serum lipid parameters', 'anthropometric measurements, SUA, 24-h UUA, fractional excretion of UA (FEUA), serum lipid parameters and 3-h oral glucose tolerance test (OGTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",8.0,0.0321225,The weight and serum lipid parameters showed no differences before and after treatment with dapagliflozin for one week.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Shuaifuyuan Street No.1, Dongcheng District, Beijing, 100730 China.'}, {'ForeName': 'Shixuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Shuaifuyuan Street No.1, Dongcheng District, Beijing, 100730 China.'}, {'ForeName': 'Yingyue', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Shuaifuyuan Street No.1, Dongcheng District, Beijing, 100730 China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Shuaifuyuan Street No.1, Dongcheng District, Beijing, 100730 China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Pharmacology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Shuaifuyuan Street No.1, Dongcheng District, Beijing, 100730 China.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00600-9']
1943,33117463,"Nab-Paclitaxel Followed by 5-Fluorouracil, Epirubicin and Cyclophosphamide in Neoadjuvant Chemotherapy for Resectable Breast Cancer: A Phase II Trial.","Background


The aim of this phase II study was to evaluate combined nab-paclitaxel (nab-PTX) with sequential anthracycline-based therapy as a neoadjuvant chemotherapy.
Methods


We enrolled 41 patients with advanced breast cancer (stage IIA - IIIC). All patients were to receive three-weekly nab-PTX (260 mg/m 2 ) for four cycles followed by three-weekly 5-fluorouracil, epirubicin and cyclophosphamide (FEC) for four cycles. Trastuzumab administration was permitted in human epidermal growth factor receptor 2 (HER2)-positive patients.
Results


The overall pathological complete response (pCR) rate was 24% (10 of 41). In patients with luminal A, luminal B (HER2-), luminal B (HER2+), triple-negative and HER2, the pCR rates were 0% (0/2), 7% (1/14), 42% (3/7), 25% (4/16) and 100% (2/2), respectively. The most significant toxicities of nab-PTX were grade 2/3 peripheral sensory neuropathy (24%) and grade 3/4 neutropenia (26%). Febrile neutropenia was not observed in any patient. The most significant toxicities of FEC were grade 3/4 neutropenia (24%) and grade 3 febrile neutropenia (9%). One patient died of sepsis secondary to pneumonia during FEC treatment.
Conclusions


Neoadjuvant chemotherapy using nab-PTX with trastuzumab every 3 weeks followed by FEC was suitably tolerated and associated with a high pCR rate of 55% for patients with HER2-positive breast cancer.",2020,Febrile neutropenia was not observed in any patient.,"['patients with HER2-positive breast cancer', 'human epidermal growth factor receptor 2 (HER2)-positive patients', '41 patients with advanced breast cancer (stage IIA - IIIC', 'Resectable Breast Cancer']","['5-fluorouracil, epirubicin and cyclophosphamide (FEC', 'combined nab-paclitaxel (nab-PTX) with sequential anthracycline-based therapy', 'Nab-Paclitaxel Followed by 5-Fluorouracil, Epirubicin and Cyclophosphamide', 'Trastuzumab', 'PTX']","['overall pathological complete response (pCR) rate', 'Febrile neutropenia', 'toxicities of FEC were grade 3/4 neutropenia', 'grade 3 febrile neutropenia', 'toxicities of nab-PTX were grade 2/3 peripheral sensory neuropathy', 'luminal B (HER2-), luminal B (HER2+), triple-negative and HER2, the pCR rates', 'grade 3/4 neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",41.0,0.0276718,Febrile neutropenia was not observed in any patient.,"[{'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kin', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Maeda', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Ueno', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Fujihara', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-0914, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Breast Surgery, Sanwa Hospital, 7-379 Higure, Matsudo-shi, Chiba 270-2253, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kajiwara', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-0914, Japan.'}, {'ForeName': 'Mitsuya', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hiraki', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima 730-8518, Japan.'}]",World journal of oncology,['10.14740/wjon1333']
1944,33117503,Effect of adding dexmedetomidine or remifentanil to thiopental in patients with mood disorder candidate for electroconvulsive therapy.,"Electroconvulsive therapy (ECT) is one of the appropriate treatments for many neuropsychiatric patients, especially those with mood disorders. Short-term complications of ECT include agitation and postictal. In this study, we compared the addition of dexmedetomidine or remifentanil to thiopental as the main anaesthetic used in ECT. In this double-blind randomised clinical trial, 90 patients with mood disorders (candidates for ECT) were divided into two groups based on their therapy: dexmedetomidine or remifentanil. In the first group (DG), patients were slowly injected intravenously with 0.5 μg/kg dexmedetomidine before induction of anesthesia. In the second group (GR), 100 μg of remifentanil was slowly injected intravenously.In addition, we collected demographic information such as respiratory rate, heart pulse rate, seizure time, mean of arterial blood pressure, recovery duration and the oxygen arterial saturation recorded after recovery. Data obtained were analysed by use of statistical software, SPSS-23. The mean age of both groups was approximately 37 years with the majority being men. There was no significant difference between the two groups in terms of age and sex, blood pressure, heart rate, duration of seizures and arterial oxygen saturation before ECT. The mean blood pressure and heart rate in the recovery group were lower in the dexmedetomidine group than in the remifentanil group and the hemodynamics in the dexmedetomidine group were more stable. The recovery time in the dexmedetomidine group was longer than that of the remifentanil group (p = 0.001). Both groups had approximately the same satisfaction and the rate of agitation after ECT was the same. Both remifentanil and dexmedetomidine as adjuvants lead to a decrease in patients' post-ECT hyperdynamic responses. In our study, we demonstrated that the effect of dexmedetomidine is greater than remifentanil. On the other hand, neither dexmedetomidine nor remifentanil had a negative effect on seizure duration, but dexmedetomidine significantly prolonged recovery time, when compared to remifentanil.",2020,"There was no significant difference between the two groups in terms of age and sex, blood pressure, heart rate, duration of seizures and arterial oxygen saturation before ECT.","['mean age of both groups was approximately 37 years with the majority being men', '90 patients with mood disorders (candidates for ECT', 'patients with mood disorder candidate for electroconvulsive therapy']","['Electroconvulsive therapy (ECT', 'thiopental', 'dexmedetomidine', 'remifentanil', 'dexmedetomidine or remifentanil']","['recovery time', 'age and sex, blood pressure, heart rate, duration of seizures and arterial oxygen saturation before ECT', 'seizure duration', 'respiratory rate, heart pulse rate, seizure time, mean of arterial blood pressure, recovery duration and the oxygen arterial saturation', 'rate of agitation', 'mean blood pressure and heart rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0730597', 'cui_str': 'Duration of seizure'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",90.0,0.05612,"There was no significant difference between the two groups in terms of age and sex, blood pressure, heart rate, duration of seizures and arterial oxygen saturation before ECT.","[{'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Heidarbeigi', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamilian', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Alaghemand', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Departmentof Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}]",European journal of translational myology,['10.4081/ejtm.2020.8877']
1945,33117723,"Self-management program versus usual care for community-dwelling older adults with multimorbidity: A pragmatic randomized controlled trial in Ontario, Canada.","Background


Multimorbidity, the co-existence of 2+ (or 3+) chronic diseases in an individual, is an increasingly common global phenomenon leading to reduced quality of life and functional status, and higher healthcare service use and mortality. There is an urgent need to develop and test new models of care that incorporate the components of multimorbidity interventions recommended by international organizations, including care coordination, interdisciplinary teams, and care plans developed with patients that are tailored to their needs and preferences.
Purpose


To determine the effectiveness of a 6-month, community-based, multimorbidity intervention compared to usual home care services for community-dwelling older adults (age 65+ years) with multimorbidity (3+ chronic conditions) that were newly referred to and receiving home care services.
Methods


A pragmatic, parallel, two-arm randomized controlled trial evaluated the intervention, which included in-home visits by an interdisciplinary team, personal support worker visits, and monthly case conferences. The study took place in two sites in central Ontario, Canada. Eligible and consenting participants were randomly allocated to the intervention and control group using a 1:1 ratio. The participants, statistician/analyst, and research assistants collecting assessment data were blinded. The primary outcome was the Physical Component Summary (PCS) score of the 12-Item Short-Form health survey (SF-12). Secondary outcomes included the SF-12 Mental Component Summary (MCS) score, Center for Epidemiological Studies of Depression (CESD-10), Generalized Anxiety Disorder (GAD-7), Self-Efficacy for Managing Chronic Disease, and service use and costs. Analysis of covariance (ANCOVA) tested group differences using multiple imputation to address missing data, and non-parametric methods explored service use and cost differences.
Results


59 older adults were randomized into the intervention (n = 30) and control (n = 29) groups. At baseline, groups were similar for the primary outcome and number of chronic conditions (mean of 8.6), but the intervention group had lower mental health status. The intervention was cost neutral and no significant group differences were observed for the primary outcome of PCS from SF-12 (mean difference: -4.94; 95% CI: -12.53 to 2.66; p = 0.20) or secondary outcomes.
Conclusion


We evaluated a 6-month, self-management intervention for older adults with multimorbidity. While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes. Recruitment and retention challenges were significant obstacles limiting our ability to assess intervention effectiveness. Yet, the intervention was grounded in internationally-endorsed recommendations and implemented in a practice setting (home care) viewed as a key upstream resource fostering independence in older adults. These features collectively support the identification of ways to recruit/retain older adults and test alternative implementation strategies for interventions that are based on sound principles of multimorbidity management.",2020,"While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes.","['older adults', 'community-dwelling older adults with multimorbidity', 'Eligible and consenting participants', '59 older adults', 'community-dwelling older adults (age 65+ years) with multimorbidity (3+ chronic conditions) that were newly referred to and receiving home care services', 'older adults with multimorbidity']","['community-based, multimorbidity intervention', 'Self-management program versus usual care', 'usual home care services', 'self-management intervention']","['number of chronic conditions', 'lower mental health status', 'Physical Component Summary (PCS) score of the 12-Item Short-Form health survey (SF-12', 'SF-12 Mental Component Summary (MCS) score, Center for Epidemiological Studies of Depression (CESD-10), Generalized Anxiety Disorder (GAD-7), Self-Efficacy for Managing Chronic Disease, and service use and costs', 'PCS from SF-12']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",59.0,0.0793084,"While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit (ACHRU), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit (ACHRU), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'Aging, Community and Health Research Unit (ACHRU), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bartholomew', 'Affiliation': 'Aging, Community and Health Research Unit (ACHRU), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Griffith', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marie-Lee', 'Initials': 'ML', 'LastName': 'Yous', 'Affiliation': 'Aging, Community and Health Research Unit (ACHRU), McMaster University, Hamilton, Ontario, Canada.'}]",Journal of comorbidity,['10.1177/2235042X20963390']
1946,33117837,Reanalysis of the Effect of Vitamin C on Mortality in the CITRIS-ALI Trial: Important Findings Dismissed in the Trial Report.,,2020,,[],['Vitamin C'],['Mortality'],[],"[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0781541,,"[{'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Hemilä', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chalker', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}]",Frontiers in medicine,['10.3389/fmed.2020.590853']
1947,33117855,Symptoms of COVID-19 Outpatients in the United States.,"Background


Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel pathogen causing the current worldwide coronavirus disease 2019 (COVID-19) pandemic. Due to insufficient diagnostic testing in the United States, there is a need for clinical decision-making algorithms to guide testing prioritization.
Methods


We recruited participants nationwide for a randomized clinical trial. We categorized participants into 3 groups: (1) those with confirmed SARS-CoV-2 infection, (2) those with probable SARS-CoV-2 infection (pending test or not tested but with a confirmed COVID-19 contact), and (3) those with possible SARS-CoV-2 infection (pending test or not tested and with a contact for whom testing was pending or not performed). We compared the frequency of self-reported symptoms in each group and categorized those reporting symptoms in early infection (0-2 days), midinfection (3-5 days), and late infection (>5 days).
Results


Among 1252 symptomatic persons screened, 316 had confirmed, 393 had probable, and 543 had possible SARS-CoV-2 infection. In early infection, those with confirmed and probable SARS-CoV-2 infection shared similar symptom profiles, with fever most likely in confirmed cases ( P  = .002). Confirmed cases did not show any statistically significant differences compared with unconfirmed cases in symptom frequency at any time point. The most commonly reported symptoms in those with confirmed infection were cough (82%), fever (67%), fatigue (62%), and headache (60%), with only 52% reporting both fever and cough.
Conclusions


Symptomatic persons with probable SARS-CoV-2 infection present similarly to those with confirmed SARS-CoV-2 infection. There was no pattern of symptom frequency over time.",2020,Confirmed cases did not show any statistically significant differences compared with unconfirmed cases in symptom frequency at any time point.,"['1252 symptomatic persons screened, 316 had confirmed, 393 had probable, and 543 had possible SARS-CoV-2 infection', 'categorized participants into 3 groups: (1) those with confirmed SARS-CoV-2 infection, (2) those with probable SARS-CoV-2 infection (pending test or not tested but with a confirmed COVID-19 contact), and (3) those with possible SARS-CoV-2 infection (pending test or not tested and with a contact for whom testing was pending or not performed']",[],"['headache', 'fever and cough', 'fatigue', 'fever', 'symptom frequency']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4302012', 'cui_str': 'Probable SARS (severe acute respiratory syndrome)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0445106', 'cui_str': 'Not performed'}]",[],"[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}]",,0.103094,Confirmed cases did not show any statistically significant differences compared with unconfirmed cases in symptom frequency at any time point.,"[{'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Galdys', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa271']
1948,33117881,Associations of equol-producing status with white matter lesion and amyloid-β deposition in cognitively normal elderly Japanese.,"Introduction


Equol, a metabolite of a soy isoflavone transformed by the gut microbiome, is anti-oxidant and anti-amyloidogenic. We assessed the associations of equol with white matter lesion normalized to total brain volume (WML%) and amyloid beta (Aβ) deposition.
Methods


From 2016 to 2018, 91 cognitively normal elderly Japanese aged 75 to 89 underwent brain magnetic resonance imaging and positron emission tomography using  11 C-Pittsburgh compound-B. Serum equol was measured using stored samples from 2008 to 2012. Equol producers were defined as individuals with serum levels >0. Producers were further divided into high (> the median) and low (≤ the median) producers.
Results


The median (interquartile range) WML% was 1.10 (0.59 to 1.61); 24.2% were Aβ positive, and 51% were equol producers. Equol-producing status (non-producers, low and high) was significantly inversely associated with WML%: 1.19, 0.89, and 0.58, respectively (trend  P  < .01). Equol-producing status was not associated with Aβ status.
Discussion


A randomized-controlled trial of equol targeting WML volume is warranted.",2020,"Equol-producing status (non-producers, low and high) was significantly inversely associated with WML%: 1.19, 0.89, and 0.58, respectively (trend  P  ","['cognitively normal elderly Japanese', 'Methods\n\n\nFrom 2016 to 2018, 91 cognitively normal elderly Japanese aged 75 to 89 underwent']","['brain magnetic resonance imaging and positron emission tomography using  11 C-Pittsburgh compound-B. Serum equol', 'equol-producing status with white matter lesion and amyloid-β deposition']","['WML', 'Equol-producing status', 'total brain volume (WML%) and amyloid beta (Aβ) deposition']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0302944', 'cui_str': 'Carbon-11'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]","[{'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",,0.0349209,"Equol-producing status (non-producers, low and high) was significantly inversely associated with WML%: 1.19, 0.89, and 0.58, respectively (trend  P  ","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sekikawa', 'Affiliation': 'Department of Epidemiology Graduate School of Public Health University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Higashiyama', 'Affiliation': 'Department of Preventive Cardiology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Lopresti', 'Affiliation': 'Department of Radiology University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Aizenstein', 'Affiliation': 'Department of Psychiatry University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Preventive Cardiology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Yuefang', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Neurological Surgery University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Chikage', 'Initials': 'C', 'LastName': 'Kakuta', 'Affiliation': 'Department of Neurology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Zheming', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Chester', 'Initials': 'C', 'LastName': 'Mathis', 'Affiliation': 'Department of Radiology University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Yoshihioro', 'Initials': 'Y', 'LastName': 'Kokubo', 'Affiliation': 'Department of Preventive Cardiology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Klunk', 'Affiliation': 'Department of Psychiatry University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': 'Department of Neurology University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Lewis H', 'Initials': 'LH', 'LastName': 'Kuller', 'Affiliation': 'Department of Epidemiology Graduate School of Public Health University of Pittsburgh Pittsburgh Pennsylvania USA.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Preventive Cardiology National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Chendi', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Department of Epidemiology Graduate School of Public Health University of Pittsburgh Pittsburgh Pennsylvania USA.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12089']
1949,33117895,Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a randomised controlled trial.,"Background


Cognitive-behavioural therapy (CBT) is effective in chronic fatigue (CF) syndrome. However, CBT has not been investigated in postinfectious CF, nor is it known whether addition of therapeutic elements from other disciplines might be useful. We explored combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.
Methods


Adolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months. Power analyses suggested that 120 participants would be needed in order to detect a moderate effect size.
Results


A total of 91 individuals with postinfectious CF were eligible, and a total of 43 were included (21 intervention group, 22 control group). Concern regarding school absence due to therapy sessions was the main reason for declining participation. Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, the primary endpoint (number of steps/day) did not differ significantly between the intervention group and the control group (difference (95% CI) =-1298 (-4874 to 2278)). Secondary outcome measures were also not significantly different among the two groups.
Conclusion


An intervention study of combined CBT and music therapy in postinfectious CF is feasible. A fully powered trial is needed to evaluate efficacy; participants' concern regarding school absence should be properly addressed to secure recruitment.
Trial registration number


ClinicalTrials ID: NCT02499302, registered July 2015.",2020,"Secondary outcome measures were also not significantly different among the two groups.
","['91 individuals with postinfectious CF were eligible, and a total of 43 were included (21 intervention group, 22 control group', 'Methods\n\n\nAdolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6\u2009months after an acute EBV infection were eligible for the present study', 'chronic fatigue (CF) syndrome', 'chronic fatigue following Epstein-Barr virus infection in adolescents', 'adolescents', '120 participants']","['CBT', 'CBT and music therapy intervention', 'CBT and music therapy programme', 'Cognitive-behavioural therapy combined with music therapy', '\n\n\nCognitive-behavioural therapy (CBT', 'combined CBT and music therapy']","['physical activity (steps/day), symptom scores, recovery rate and possible harmful effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149678', 'cui_str': 'Epstein-Barr virus disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",91.0,0.203605,"Secondary outcome measures were also not significantly different among the two groups.
","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Pediatrics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Tarjei Tørre', 'Initials': 'TT', 'LastName': 'Asprusten', 'Affiliation': 'Institutt for klinisk medisin, Universitetet i Oslo, Oslo, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Drammen Hospital, Drammen, Norway.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mangersnes', 'Affiliation': 'Pediatrics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Gro', 'Initials': 'G', 'LastName': 'Trondalen', 'Affiliation': 'Center for Music and Health, Norwegian College of Music, Oslo, Norway.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'van Roy', 'Affiliation': 'Pediatrics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'Department of Public Health and Nursing, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Vegard Bruun', 'Initials': 'VB', 'LastName': 'Wyller', 'Affiliation': 'Pediatrics, Akershus University Hospital, Oslo, Norway.'}]",BMJ paediatrics open,['10.1136/bmjpo-2020-000797']
1950,33118118,Multicenter prospective trial of total gastrectomy versus proximal gastrectomy for upper third cT1 gastric cancer.,"BACKGROUND


The appropriate surgical procedure for patients with upper third early gastric cancer is controversial. We compared total gastrectomy (TG) with proximal gastrectomy (PG) in this patient population.
METHODS


A multicenter, non-randomized trial was conducted, with patients treated with PG or TG. We compared short- and long-term outcomes between these procedures.
RESULTS


Between 2009 and 2014, we enrolled 254 patients from 22 institutions; data from 252 were included in the analysis. These 252 patients were assigned to either the PG (n = 159) or TG (n = 93) group. Percentage of body weight loss (%BWL) at 1 year after surgery, i.e., the primary endpoint, in the PG group was significantly less than that of the TG group (- 12.8% versus - 16.9%; p = 0.0001). For short-term outcomes, operation time was significantly shorter for PG than TG (252 min versus 303 min; p < 0.0001), but there were no group-dependent differences in blood loss and postoperative complications. For long-term outcomes, incidence of reflux esophagitis in the PG group was significantly higher than that of the TG group (14.5% versus 5.4%; p = 0.02), while there were no differences in the incidence of anastomotic stenosis between the two (5.7% versus 5.4%; p = 0.92). Overall patient survival rates were similar between the two groups (3-year survival rates: 96% versus 92% in the PG and TG groups, respectively; p = 0.49).
CONCLUSIONS


Patients who underwent PG were better able to control weight loss without worsening the prognosis, relative to those in the TG group. Optimization of a reconstruction method to reduce reflux in PG patients will be important.",2020,"Overall patient survival rates were similar between the two groups (3-year survival rates: 96% versus 92% in the PG and TG groups, respectively; p = 0.49).
","['254 patients from 22 institutions; data from 252 were included in the analysis', 'patients with upper third early gastric cancer', 'upper third cT1 gastric cancer', 'Between 2009 and 2014', 'patients treated with PG or TG', '252 patients']","['TG', 'total gastrectomy versus proximal gastrectomy', 'total gastrectomy (TG) with proximal gastrectomy (PG']","['incidence of reflux esophagitis', 'Percentage of body weight loss', '3-year survival rates', 'control weight loss', 'operation time', 'blood loss and postoperative complications', 'Overall patient survival rates', 'incidence of anastomotic stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0227187', 'cui_str': 'Structure of upper third of esophagus'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}]","[{'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}]",254.0,0.0734551,"Overall patient survival rates were similar between the two groups (3-year survival rates: 96% versus 92% in the PG and TG groups, respectively; p = 0.49).
","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan. myamasaki@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Demura', 'Affiliation': 'Department of Surgery, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Surgery, Higashiosaka City Medical Center, Osaka, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ebisui', 'Affiliation': 'Department of Surgery, Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takachi', 'Affiliation': 'Department of Surgery, Kinki Central Hospital, Hyogo, Japan.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Takayama', 'Affiliation': 'Department of Surgery, Saiseikai Senri Hospital, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Itami Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': 'Department of Surgery, Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fukuda', 'Affiliation': 'Department of Surgery, Kindai University Nara Hospital, Osaka, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamadaoka, Suita, Osaka, 565-0879, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01129-6']
1951,33118138,Mindful Age and Technology: a Qualitative Analysis of a Tablet/Smartphone App Intervention Designed for Older Adults.,"The global population is aging while modern healthcare systems are responding with limited success to the growing care demands of the senior population. Capitalizing on recent technological advancements, new ways to improve older adults' quality of life have recently been implemented. The current study investigated, from a qualitative point of view, the utility of a mindfulness-based smartphone application for older adults. A description of the older adults' experience with the smartphone application designed to enhance well-being and mindfulness will be presented. Participants'general beliefs about the benefits of technology for personal well-being will also be discussed. 68 older adults were recruited from different education centers for seniors. Participants were randomly assigned to two groups: a) a treatment group, which received the smartphone application intervention (n = 34), or b) a waitlist control group (n = 34). The experimental intervention included the utilization of a smartphone app designed specifically for improving older adult well-being and mindfulness levels. Participants completed semi-structured interviews evaluating participants' treatment experience and technology-acceptance at recruitment (T0, baseline) and post-intervention (T1, post-intervention). Through thematic analysis, four themes were identified from verbatim responses of both interviews: Utility of technology for health, Impressions of technology, Mindful-benefits of smartphone application usage, and Smartphone application usage as a means to improve interpersonal relationships. Participants showed a positive experience of the app intervention. Qualitative analysis underlined the main Mindfulness-benefits reported by participants and the potentially crucial role of ""Langerian"" mindfulness in the relationship between older adults and health technology.",2020,The global population is aging while modern healthcare systems are responding with limited success to the growing care demands of the senior population.,"['older adults', '68 older adults were recruited from different education centers for seniors', 'Older Adults']","['mindfulness-based smartphone application', 'waitlist control group', 'Tablet/Smartphone App Intervention', 'smartphone application intervention']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],68.0,0.0242925,The global population is aging while modern healthcare systems are responding with limited success to the growing care demands of the senior population.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vailati Riboni', 'Affiliation': 'Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy. f.vailatiriboni@gmail.com.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Sadowski', 'Affiliation': 'Department of Educational and Counselling Psychology, McGill University, Montreal, Canada.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Comazzi', 'Affiliation': 'IRCCS Santa Maria Nascente, Fondazione Don Gnocchi, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pagnini', 'Affiliation': 'Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy.'}]",Integrative psychological & behavioral science,['10.1007/s12124-020-09580-x']
1952,33118193,The implications of noncompliance for randomized trials with partial nesting due to group treatment.,"Analyses of trials of group administered treatments require an identifier for therapy group to account for clustering by group. All patients randomized to receive the group administered treatment could be assigned an intended group identifier following randomization. Alternatively, an actual group could be based on those patients that comply with group therapy. We investigate the implications for intention-to-treat (ITT) analyses of using either the intended or actual group to adjust for the clustering effect. We also consider causal models using the actual group. A simulation study showed that ITT estimates based on random effects models or GEE with an exchangeable correlation matrix performed much better when using the intended group than the actual group. OLS with robust standard errors performed well with both. Most compliance average causal effect (CACE) models performed well. While practical constraints of the clinical setting may determine the choice between an intended or actual group analyses, it is desirable to record both. An ITT analysis using mixed models can then be fitted using the intended group with data generation assumptions checked by a causal model using the actual group. Where an ITT analysis is based on the actual group, worse outcome for never-takers than compliers may allow one to infer that some estimators are biased toward no treatment effect. The work here is motivated and illustrated by a trial of a group therapy, but also has relevance to trials with treatment related clustering due to therapist examples of which include physical and talking therapies or surgery.",2020,OLS with robust standard errors performed well with both.,[],[],[],[],[],[],,0.0313269,OLS with robust standard errors performed well with both.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, School of Health Sciences, University of Manchester, Manchester, UK.'}]",Statistics in medicine,['10.1002/sim.8778']
1953,33118206,A brief positive psychological intervention prior to a potentially stressful task facilitates more challenge-like cardiovascular reactivity in high trait anxious individuals.,"When confronted with stress, anxious individuals tend to evaluate the demands of an upcoming encounter as higher than the available resources, thus, indicating threat evaluations. Conversely, evaluating available resources as higher than the demands signals challenge. Both types of evaluations have been related to specific cardiovascular response patterns with higher cardiac output relative to peripheral resistance indicating challenge and higher peripheral resistance relative to cardiac output signaling threat. The aim of this research was to evaluate whether a brief positive psychological exercise (best possible selves intervention) prior to a potentially stress-evoking task shifted the cardiovascular profile in trait anxious individuals from a threat to a challenge type. We randomly assigned 74 participants to either a best possible selves or a control exercise prior to performing a sing a song stress task and assessed their level of trait anxiety. Cardiac output (CO) and total peripheral resistance (TPR) were continuously recorded through baseline, preparation, stress task, and recovery, respectively, as well as self-reported affect. Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group. While high trait anxious individuals in the control group showed increasing TPR reactivity, they exhibited a nonsignificant change in the best possible selves group. Moreover, in the latter group a stress-related decrease in positive affect in high trait anxious participants was prevented. Findings suggest that concentrating on strengths and positive assets prior to a potentially stressful encounter could trigger a more adaptive coping in trait anxious individuals.",2020,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"['trait anxious individuals from a threat to a challenge type', 'high trait anxious individuals']","['positive psychological intervention', 'control exercise prior to performing a sing a song stress task', 'positive psychological exercise (best possible selves intervention']","['TPR reactivity', 'Cardiac output (CO) and total peripheral resistance (TPR', 'Trait anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",74.0,0.0288945,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"[{'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rominger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Aluani', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}]",Psychophysiology,['10.1111/psyp.13709']
1954,33118309,Glycemic profiles of diverse patients with type 2 diabetes using basal insulin: MOBILE study baseline data.,"Basal insulin is often prescribed to patients with sub-optimally controlled type 2 diabetes (T2D); however, its therapeutic efficacy is inadequate in many. During the MOBILE study's baseline phase, we evaluated 173 participants' continuous glucose monitoring (CGM) data (mean±SD age 57±9 years; 50% female; glycated hemoglobin 9.1% [range, 7.1-11.6%]; 40% using sulfonylureas; 19% using NPH; reported self-monitored blood glucose [SMBG] frequency median 1.0 checks/day) who were using basal, but not prandial insulin. Blinded CGM data were recorded for 10 days prior to randomization. Mean glucose value was 208±47 mg/dL and lowest in the early morning. Mean time in the 70-180 mg/dL range was 9.6±6.1 h/day (40%±25%). Hyperglycemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) h/day with glucose >180 and >250 mg/dL, respectively. Hypoglycemia was infrequent (median [IQR] 0 [0, 4.3] minutes/day (0.0% [0.0%, 0.3%]) with glucose <70 mg/dL). Blinded CGM highlights limitations of infrequent SMBG in T2D basal insulin users and allows characterization of hyperglycemia and hypoglycemia in basal insulin users with suboptimal control. The MOBILE study randomized phase will define the benefits of using real-time CGM compared to SMBG in this population. This article is protected by copyright. All rights reserved.",2020,"Hyperglycemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) h/day with glucose >180 and >250 mg/dL, respectively.","['patients with sub-optimally controlled type 2 diabetes (T2D', 'diverse patients with type 2 diabetes using basal insulin', ""173 participants' continuous glucose monitoring (CGM) data (mean±SD age 57±9\u2009years; 50% female; glycated hemoglobin 9.1% [range, 7.1-11.6%]; 40% using sulfonylureas; 19% using NPH; reported self-monitored blood glucose [SMBG] frequency median 1.0 checks/day) who were using basal, but not prandial insulin""]",[],"['Glycemic profiles', 'Hypoglycemia', 'Mean time', 'Mean glucose value', 'Hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.0775585,"Hyperglycemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) h/day with glucose >180 and >250 mg/dL, respectively.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ruedy', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Martens', 'Affiliation': 'International Diabetes Center, Park Nicollet Clinic, Brooklyn Center, MN.'}, {'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Nelly M', 'Initials': 'NM', 'LastName': 'Njeru', 'Affiliation': 'Dexcom, Inc., San Diego, CA.'}, {'ForeName': 'Stayce E', 'Initials': 'SE', 'LastName': 'Beck', 'Affiliation': 'Dexcom, Inc., San Diego, CA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, CA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14238']
1955,30792343,Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation.,,2019,,['patients with symptomatic COPD and history of one\xa0moderate exacerbation'],['Extrafine triple therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0182422,,"[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK dsingh@meu.org.uk.'}, {'ForeName': 'Leonardo M', 'Initials': 'LM', 'LastName': 'Fabbri', 'Affiliation': 'Section of Cardiorespiratory and Internal Medicine, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Corradi', 'Affiliation': 'Dept Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global Clinical Development, Chiesi USA, Inc., Cary, NC, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Guasconi', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vezzoli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Petruzzelli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Section of Cardiorespiratory and Internal Medicine, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy.'}]",The European respiratory journal,['10.1183/13993003.00235-2019']
1956,31023842,French experience of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.,"AIMS


To evaluate safety and efficacy of balloon pulmonary angioplasty (BPA) in a large cohort of patients with chronic thromboembolic pulmonary hypertension (CTEPH).
METHODS


From 2014 to 2017, 184 inoperable CTEPH patients underwent 1006 BPA sessions. Safety and efficacy during the first 21 months (initial period) were compared with those of the last 21 months (recent period). A total of 154 patients had a full evaluation after a median duration of 6.1 months.
RESULTS


Overall, there was a significant improvement in New York Heart Association functional class, 6-min walk distance (mean change +45 m), and a significant decrease in mean pulmonary artery pressure (PAP) and in pulmonary vascular resistance (PVR) by 26% and 43%, respectively. The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05). The main complications included lung injury, which occurred in 9.1% of 1006 sessions (13.3% in the initial period  versus  5.9% in the recent period; p<0.001). Per-patient multivariate analysis revealed that baseline mean PAP and the period during which BPA procedure was performed (recent  versus  initial period) were the strongest factors related to the occurrence of lung injury. 3-year survival was 95.1%.
CONCLUSION


This study confirms that a refined BPA strategy improves short-term symptoms, exercise capacity and haemodynamics in inoperable CTEPH patients with an acceptable risk-benefit ratio. Safety and efficacy improve over time, underscoring the unavoidable learning curve for this procedure.",2019,"The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05).","['patients with chronic thromboembolic pulmonary hypertension (CTEPH', '154 patients had a full evaluation after a median duration of 6.1\u2005months', 'From 2014 to 2017, 184 inoperable CTEPH patients underwent 1006 BPA sessions', 'inoperable CTEPH patients with an acceptable risk-benefit ratio', 'chronic thromboembolic pulmonary hypertension']","['balloon pulmonary angioplasty', 'balloon pulmonary angioplasty (BPA']","['mean pulmonary artery pressure (PAP) and in pulmonary vascular resistance (PVR', 'Safety and efficacy', 'New\xa0York Heart Association functional class, 6-min walk distance', 'safety and efficacy', 'short-term symptoms, exercise capacity and haemodynamics', '3-year survival', 'mean PAP and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",184.0,0.0307558,"The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05).","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brenot', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jaïs', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France xavier.jais@gmail.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia Alonso', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Gerardin', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Mussot', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Mercier', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fabre', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Parent', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Jevnikar', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montani', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Savale', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Fadel', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}]",The European respiratory journal,['10.1183/13993003.02095-2018']
1957,33124156,Comparison of therapeutic effects between artificial dermis combined with autologous split-thickness skin grafting and autologous intermediate-thickness skin grafting alone in severely burned patients: A prospective randomised study.,"The purpose of this study was to evaluate the therapeutic effects of artificial dermis combined with autologous split-thickness skin grafting (STSG) compared with autologous intermediate-thickness skin grafting (ITSG) alone in severely burned patients. Fifty-six severely burned patients admitted to our hospital from December 2017 to January 2019 were enrolled and evenly grouped according to the random number table method [AD-STSG group: 28 patients, receiving the treatment of artificial dermis (AD) combined with autologous STSG; ITSG group: 28 patients, receiving autologous ITSG treatment alone]. The healing time and Vancouver Scar Scale (VSS) score of the donor area and graft area, survival rate and infection status of the autologous skin, psychological status (determined by Self-rating Anxiety Scale and Self-rating Depression Scale), and the activity of functional parts of all enrolled patients were included in the evaluation. General items of patients in AD-STSG group and ITSG group, including age, sex, and degree of burn, were all comparable. A significantly shortened healing time of donor skin in AD-STSG group was observed when compared with ITSG group (P < .05) while the recipient skin healed in the same tendency between the two groups. In addition, 21 days after the operation, AD-STSG group presented with significantly higher survival rate of graft skin than ITSG group (P < .05) while same infection status was observed in the two groups. Significantly lower VSS scores were found in AD-STSG group than that in ITSG group 3-, 6- and 10-months after operation (P < .05). Statistical difference regarding psychological status of patients from two groups was unobservable before operation while significantly lower Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores were found in AD-STSG group than that in ITSG group 3-, 6- and 10-months after operation (P < .05). Also, AD-STSG group presented improved mobility of functional part than that in ITSG group 10-months after operation without statistical difference (P = .051). Artificial dermis combined with autologous split-thickness skin grafting showed better therapeutic outcomes for the treatment of severely burned patients than autologous intermediate-thickness skin grafting in terms of graft healing time, scar formation, psychological recovery, and perhaps in functional reconstruction.",2020,Significantly lower VSS scores were found in AD-STSG group than that in ITSG group,"['severely burned patients', 'Fifty-six severely burned patients admitted to our hospital from December 2017 to January 2019 were enrolled and evenly grouped according to the random number table method [AD-STSG group: 28 patients, receiving the treatment of', 'group: 28 patients, receiving']","['autologous intermediate-thickness skin grafting (ITSG', 'autologous intermediate-thickness skin grafting', 'artificial dermis (AD) combined with autologous STSG; ITSG', 'artificial dermis combined with autologous split-thickness skin grafting and autologous intermediate-thickness skin grafting alone', 'artificial dermis combined with autologous split-thickness skin grafting (STSG', 'ITSG', 'Artificial dermis combined with autologous split-thickness skin grafting', 'autologous ITSG treatment alone']","['VSS scores', 'healing time and Vancouver Scar Scale (VSS) score of the donor area and graft area, survival rate and infection status of the autologous skin, psychological status (determined by Self-rating Anxiety Scale and Self-rating Depression Scale', 'mobility of functional part', 'graft healing time, scar formation, psychological recovery, and perhaps in functional reconstruction', 'survival rate of graft skin', 'therapeutic outcomes', 'Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores', 'healing time of donor skin']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0040748', 'cui_str': 'Transplanted skin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0260785', 'cui_str': 'Skin donor'}]",56.0,0.0146529,Significantly lower VSS scores were found in AD-STSG group than that in ITSG group,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shang', 'Affiliation': ""Department of Burns, The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Yan-Hua', 'Initials': 'YH', 'LastName': 'Lu', 'Affiliation': ""Department of Burns, The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Department of General Surgery, The First People's Hospital of Tai'an, Shandong First Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hou', 'Affiliation': ""Department of Burns, The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong, China.""}]",International wound journal,['10.1111/iwj.13518']
1958,33124189,Laser trabeculoplasty in newly diagnosed multi-treated glaucoma patients.,"PURPOSE


To evaluate the intraocular pressure (IOP)-lowering effect of laser trabeculoplasty (LTP) in eyes which IOP had been substantially reduced by intensive topical treatment for one week.
METHODS


Patients with newly diagnosed open-angle glaucoma were randomized to treatment with three IOP-lowering substances. One week later, 360° argon or selective LTP was performed. IOP was measured before LTP and at one-, three-, six- and 12-month post-LTP. The patients were part of the Glaucoma Intensive Treatment Study (GITS).
RESULTS


Mean IOP (± SD) in 152 eyes of 122 patients was 14.0 (± 3.5) mmHg just before LTP. For every mmHg higher IOP prior to LTP, the IOP was reduced by an additional 0.6 mmHg at 12 months. The IOP was significantly reduced at all follow-up visits from -2.6 (± 3.1) mmHg at one month to -2.1 (± 3.8) mmHg at 12 months in eyes with pre-LTP IOP ≥ 15 mmHg, while no significant IOP reduction was seen in eyes with pre-LTP IOP < 15 mmHg. Older age, argon LTP and male sex were associated with larger IOP reduction after 12 months, whereas presence of exfoliation syndrome was associated with a smaller IOP reduction. No severe complications were reported.
CONCLUSION


Success of LTP was highly dependent on the IOP level prior to LTP treatment. A sustained significant IOP reduction was seen in eyes with pre-LTP IOP ≥ 15 mmHg whereas no such effect was seen in eyes with pre-LTP IOP < 15 mmHg. Thus, LTP can be considered in eyes with multi-treatment when target pressure of < 15 mmHg is not achieved.",2020,"No severe complications were reported.
","['patients were part of the Glaucoma Intensive Treatment Study (GITS', 'newly diagnosed multi-treated glaucoma patients', 'Patients with newly diagnosed open-angle glaucoma', '152 eyes of 122 patients was 14.0 (± 3.5']","['360° argon or selective LTP', 'Laser trabeculoplasty', 'laser trabeculoplasty (LTP', 'LTP', 'IOP-lowering substances']","['Mean IOP (± SD', 'intraocular pressure', 'severe complications', 'IOP reduction', 'IOP', 'larger IOP reduction', 'IOP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0003781', 'cui_str': 'Argon'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0395482', 'cui_str': 'Laser trabeculoplasty'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0324502,"No severe complications were reported.
","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rasmuson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Boel', 'Initials': 'B', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lindén', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Heijl', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Aspberg', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Andersson-Geimer', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Gauti', 'Initials': 'G', 'LastName': 'Jóhannesson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}]",Acta ophthalmologica,['10.1111/aos.14576']
1959,33124454,"Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study.","The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH ® ) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth ® , Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores ( n  = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively ( p  < 0.01 vs. corresponding basal values). Individual FSFI domain scores ( n  = 569) significantly ( p  < 0.001) increased after VEL-SMOOTH ®  treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively ( p  < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH ®  treatment may improve sexual function in postmenopausal women suffering from GSM.",2020,Individual FSFI domain scores ( n  = 569) significantly ( p  < 0.001) increased after VEL-SMOOTH ®  treatment and remained significantly higher up to the 24th week after the end of treatment.,"['postmenopausal women suffering from the genitourinary syndrome of menopause (GSM', 'postmenopausal women suffering from GSM', '1081 postmenopausal women (age 54.3\u2009±\u20093.9 years']","['vaginal erbium laser (VEL-SMOOTH ® ', 'vaginal erbium laser', 'erbium laser (XS Fotona Smooth ® , Fotona, Ljubljana, Slovenia', 'VEL-SMOOTH ®']","['Individual FSFI domain scores', 'Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R', 'adverse events', 'FSDS-R scores', 'sexual function', 'Sexual function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",1081.0,0.0135046,Individual FSFI domain scores ( n  = 569) significantly ( p  < 0.001) increased after VEL-SMOOTH ®  treatment and remained significantly higher up to the 24th week after the end of treatment.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gambacciani', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Pisa, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Albertin', 'Affiliation': 'Gynecological Clinic Elysium, Albignasego (Padova), Italy.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Torelli', 'Affiliation': 'Centro Palmer, Reggio Emilia, Italy.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Bracco', 'Affiliation': 'Ospedale Campo di Marte, Lucca, Italy.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Casagrande', 'Affiliation': 'Studio Medico, Novara, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Martella', 'Affiliation': 'Centro Medico Radiologico 3P, Noventa di Piave, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Perugia, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Alfieri', 'Affiliation': 'Centro Mediprò Bologna, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Russo', 'Affiliation': 'Centro Medico Demetra, Grottaferrata, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cervigni', 'Affiliation': 'Clinica Paideia, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1804544']
1960,33124470,Examination of emotional contagion and social anxiety using novel video stimuli.,"BACKGROUND AND OBJECTIVES


Socially anxious individuals often exhibit signs of anxiety that might elicit discomfort in others and negatively influence their interactions, due in part to emotional contagion. However, there is limited research examining the phenomenon of emotional contagion in social anxiety, which is the topic of the current study.
DESIGN AND METHODS


An experimental design was used in which undergraduate psychology students ( N  = 128) were assigned to either an experimental condition (watching a video of a socially anxious presenter) or a control condition (watching a video of a nonanxious presenter). Various measures were administered to assess social anxiety, emotional contagion, state anxiety, and related constructs.
RESULTS


After controlling for baseline anxiety levels, participants in the experimental condition reported significantly higher levels of anxiety during and immediately after watching the video compared to individuals in the control condition (multivariate analysis of covariance, analysis of variance). Similar results were found across both conditions in participants with higher levels of trait social anxiety and higher public speaking anxiety (moderated regression analyses).
CONCLUSIONS


The findings suggest that social anxiety may be emotionally contagious, and provides insight into the role that emotional contagion may play in the association between social anxiety and interpersonal functioning.",2020,"After controlling for baseline anxiety levels, participants in the experimental condition reported significantly higher levels of anxiety during and immediately after watching the video compared to individuals in the control condition (multivariate analysis of covariance, analysis of variance).",['undergraduate psychology students ( N \u2009=\u2009128'],['experimental condition (watching a video of a socially anxious presenter) or a control condition (watching a video of a nonanxious presenter'],"['social anxiety, emotional contagion, state anxiety, and related constructs', 'trait social anxiety and higher public speaking anxiety', 'levels of anxiety']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",128.0,0.0280087,"After controlling for baseline anxiety levels, participants in the experimental condition reported significantly higher levels of anxiety during and immediately after watching the video compared to individuals in the control condition (multivariate analysis of covariance, analysis of variance).","[{'ForeName': 'Pam V', 'Initials': 'PV', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Canada.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Canada.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Canada.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1839729']
1961,33124472,Stress and information processing: acute psychosocial stress affects levels of mental abstraction.,"BACKGROUND


: One mechanism by which acute psychosocial stress effects health-related cognitions and behaviors is through changes in the level of mental abstraction when processing information. However, it is unclear whether levels of mental abstraction would be higher or lower after an acute psychosocial stressor.
OBJECTIVES


: This research examined acute psychosocial stress's impact on levels of mental abstraction.
DESIGN


: Randomized between-subjects experimental design.
METHODS


: A diverse sample of 164 undergraduate students aged 18-24 years old were randomly assigned to an acute psychosocial stressor or non-stressful control condition. Blood pressure (BP), heart rate (HR), and negative affect were monitored throughout the study and mental abstraction was measured at the end of each condition.
RESULTS


: Mental abstraction was statistically significantly higher (i.e., more abstract) after the stress condition than after the control condition ( p  = 0.005,  d  = 0.44). This association was partially explained by negative affect ( p  = 0.017), but not BP or HR ( ps  > 0.60) .
CONCLUSIONS


: Acute psychosocial stress is associated with higher levels of mental abstraction after the stressor. These findings may have implications for stress-relevant interventions as accounting for the level of mental abstraction may enhance the efficacy of the intervention.",2020,"RESULTS


: Mental abstraction was statistically significantly higher (i.e., more abstract) after the stress condition than after the control condition ( p  = 0.005,  d  = 0.44).",['164 undergraduate students aged 18-24 years old'],['acute psychosocial stressor or non-stressful control condition'],"['Blood pressure (BP), heart rate (HR), and negative affect']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",164.0,0.0478753,"RESULTS


: Mental abstraction was statistically significantly higher (i.e., more abstract) after the stress condition than after the control condition ( p  = 0.005,  d  = 0.44).","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Felt', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Depaoli', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}, {'ForeName': 'Jitske', 'Initials': 'J', 'LastName': 'Tiemensma', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1839646']
1962,33113211,Strength training restores force-generating capacity in patients with schizophrenia.,"Patients with schizophrenia spectrum disorders have impaired skeletal muscle force-generating capacity (FGC) of the lower extremities, i.e. one repetition maximum (1RM) and rapid force development, and poor functional performance. We therefore investigated if 12 weeks of maximal strength training (MST) could (1) restore FGC and functional performance to the level of healthy references, (2) increase patient activation and quality of life, and (3) explore associations between symptom severity, defined daily dose of medication, illness duration, level of patient activation and improvements in FGC and functional performance. Forty-eight outpatients were randomized to a training group (TG) or control group (CG). TG performed leg press MST 2d·week -1  at ~90% 1RM. The CG received two introductory training sessions and encouragement to train independently. Leg press 1RM, rapid force development, a battery of functional performance tests, Patient Activation Measure-13 and 36-Item Short Form Health Survey were tested. Healthy references performed baseline tests of FGC and functional performance. Thirty-six patients completed the study (TG: 17, CG: 19). TG improved 1RM (28%) and rapid force development (20%, both p<0.01) to a level similar to healthy references, while no change was apparent in the CG. TG's improvement in rapid force development was negatively associated with defined daily dose of medication (r=-0.5, p=0.05). Both TG and CG improved 30-second sit-to-stand test performance (p<0.05) which was associated with improved rapid force development (r=0.6, p<0.05). In conclusion, twelve weeks of MST restored patients' lower extremity FGC to a level similar to healthy references and improved 30-second sit-to-stand test performance.",2020,"TG improved 1RM (28%) and rapid force development (20%, both p<0.01) to a level similar to healthy references, while no change was apparent in the CG.","['patients with schizophrenia', 'Patients with schizophrenia spectrum disorders', 'Thirty-six patients completed the study (TG: 17, CG: 19', 'Forty-eight outpatients']","['training group (TG) or control group (CG', 'Strength training', 'maximal strength training (MST', 'MST']","['patient activation and quality of life, and (3) explore associations between symptom severity, defined daily dose of medication, illness duration, level of patient activation and improvements in FGC and functional performance', 'TG improved 1RM', 'extremity FGC', 'rapid force development', 'Leg press 1RM, rapid force development, a battery of functional performance tests, Patient Activation Measure-13 and 36-Item Short Form Health Survey']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",48.0,0.0194043,"TG improved 1RM (28%) and rapid force development (20%, both p<0.01) to a level similar to healthy references, while no change was apparent in the CG.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mathias Forsberg', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Joshua Landen', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Solveig Klaebo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Ismail Cüneyt', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Vedul-Kjelsås', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13863']
1963,33113253,Effects of including sprints during prolonged cycling on hormonal and muscular responses and recovery in elite cyclists.,"This study investigated the acute effects of including 30-s sprints during prolonged low intensity cycling on muscular and hormonal responses and recovery in elite cyclists. Twelve male cyclists (VO 2max  , 73.4±4.0 mL·kg -1  ·min -1  ) completed a randomized cross-over protocol, wherein 4 hours of cycling at 50% of VO 2max  were performed with and without inclusion of three sets of 3×30s maximal sprints (E&S vs E, work-matched). Muscle biopsies (m. vastus lateralis) and blood were sampled at Pre, immediately after (Post) and 3 h after (3h) finalizing sessions. E&S led to greater increases in mRNA-levels compared to E for markers of fat metabolism (PDK4, Δ-Log2 fold-change between E&S and E ± 95%CI Post; 2.1±0.9, Δ3h; 1.3±0.7) and angiogenesis (VEGFA, Δ3h; 0.3±0.3), and greater changes in markers of muscle protein turnover (myostatin, ΔPost; -1.4±1.2, Δ3h; -1.3±1.3; MuRF1, ΔPost; 1.5±1.2, all p<0.05). E&S showed decreased mRNA levels for markers of ion transport at 3h (Na +  -K +  α1; -0.6±0.6, CLC1; -1.0±0.8 and NHE1; -0.3±0.2, all p<0.05) and blunted responses for a marker of mitochondrial biogenesis (PGC-1α, Post; -0.3±0.3, 3h; -0.4±0.3, p<0.05) compared to E. E&S and E showed similar endocrine responses, with exceptions of GH and SHBG, where E&S displayed lower responses at Post (GH; -4.1±3.2 μg·L -1  , SHBG; -2.2±1.9 nmol·L -1  , p<0.05). Both E&S and E demonstrated complete recovery in isokinetic knee extension torque 24 h after exercise. In conclusion, we demonstrate E&S to be an effective exercise protocol for elite cyclists, which potentially leads to beneficial adaptations in skeletal muscle without impairing muscle recovery 24 h after exercise.",2020,E&S showed decreased mRNA levels for markers of ion transport at 3h,"['Twelve male cyclists (VO 2max  , 73.4±4.0 mL·kg -1  ·min -1  ', 'elite cyclists']",['30-s sprints during prolonged low intensity cycling'],"['mRNA-levels', 'mRNA levels', 'μg·L -1  , SHBG']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",12.0,0.0755787,E&S showed decreased mRNA levels for markers of ion transport at 3h,"[{'ForeName': 'Nicki Winfield', 'Initials': 'NW', 'LastName': 'Almquist', 'Affiliation': 'Inland Norway University of Applied Sciences, Institute of Public Health and Sport Sciences, Lillehammer, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': 'Inland Norway University of Applied Sciences, Institute of Public Health and Sport Sciences, Lillehammer, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Sandbakk', 'Affiliation': 'Center for Elite Sports Research, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Inland Norway University of Applied Sciences, Institute of Public Health and Sport Sciences, Lillehammer, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13865']
1964,33113277,"Comparison of the safety and efficacy of the on-demand use of sertraline, dapoxetine, and daily use of sertraline in the treatment of patients with lifelong premature ejaculation: A prospective randomised study.","This study compared the safety and efficacy of the on-demand (OD) use of sertraline (50 mg), sertraline (100 mg) and dapoxetine (30 mg), and the daily use of sertraline (50 mg) in the treatment of patients with premature ejaculation (PE). This prospective randomised study involved 120 lifelong PE patients (intravaginal ejaculatory latency time [IELT]: <1 min; Arabic Index of Premature Ejaculation [AIPE] score: < 30) without secondary causes of PE, identified between March 2018 and May 2020. Patients were divided into 4 groups (30 patients per group) and treated for 8 weeks. Assessments were conducted using the AIPE form as a diagnostic tool. Sertraline (50 mg, daily; 196.7 ± 115.5 s) and sertraline (100 mg, OD; 173.3 ± 97.0 s) had similar IELT and AIPE scores. The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01). Sertraline (100 mg, OD) had a similar efficacy to that of sertraline (50 mg, daily) and was more effective than sertraline (50 mg, OD) and dapoxetine (30 mg, OD). Sertraline (100 mg, OD) can be considered in the treatment of lifelong PE treatment, having tolerable side effects.",2020,"The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01).","['patients with premature ejaculation (PE', 'patients with lifelong premature ejaculation', '120 lifelong PE patients (intravaginal ejaculatory latency time [IELT]: <1\xa0min; Arabic Index of Premature Ejaculation [AIPE] score: < 30) without secondary causes of PE, identified between March 2018 and May 2020']","['dapoxetine', 'sertraline', 'Sertraline', 'sertraline, dapoxetine']","['similar IELT and AIPE scores', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",120.0,0.0291584,"The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01).","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Alkan', 'Initials': 'A', 'LastName': 'Cubuk', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orkunt', 'Initials': 'O', 'LastName': 'Ozkaptan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Toprak', 'Affiliation': 'Department of Urology, Health Science University, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Ozcan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kasım', 'Initials': 'K', 'LastName': 'Ertas', 'Affiliation': 'Department of Urology, School of Medicine, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Canguven', 'Affiliation': 'Department of Urology, General Hamad Hospital, Doha, Qatar.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tarhan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}]",Andrologia,['10.1111/and.13854']
1965,33113295,SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization.
METHODS


In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here.
RESULTS


At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P = 0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.
CONCLUSIONS


In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).",2020,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","['outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a', 'Outpatients with Covid-19']","['placebo', 'single intravenous infusion of neutralizing antibody LY-CoV555']","['severity of symptoms', 'viral load', 'Covid-19-related hospitalization or visit to an emergency department']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",452.0,0.572537,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029849']
1966,31777160,Left atrial structure and function and the risk of death or heart failure in atrial fibrillation.,"AIMS


The present study aimed to assess the association between left atrial (LA) structure and function and the risk for cardiovascular (CV) death or heart failure (HF) hospitalization in a population with atrial fibrillation (AF).
METHODS AND RESULTS


In a prospective echocardiographic substudy of the Effective Anticoagulation with Factor Xa Next Generation in AF-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) study, 971 patients underwent transthoracic echocardiography. The associations between LA structure (LA volume index [LAVi]) and function (LA emptying fraction [LAEF] and LA expansion index [LAEi]) and risk for the composite endpoint of CV death or HF hospitalization, and its components, were assessed. Over a median follow-up of 2.5 years, 142 patients (14.6%) experienced CV death or HF hospitalization. Higher LAVi and lower LAEF and LAEi were each associated with a higher unadjusted risk for the composite outcome and its components. After adjustment for clinical and echocardiographic confounders, only measures of impaired LA function were predictive of the composite outcome (hazard ratio [HR] per 1 standard deviation [SD] decrease in LAEF: 1.35; 95% confidence interval [CI] 1.09-1.67 [P = 0.005]; HR per 1 SD decrease in LAEi: 1.34; 95% CI 1.06-1.69 [P = 0.012]). These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
CONCLUSIONS


In patients with AF, LA dysfunction was significantly associated with an increased risk for CV death or HF hospitalization and was more predictive of these outcomes than LA size. These parameters may help to identify AF patients at greatest risk for the development of HF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT00781391.",2019,"These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
","['971 patients underwent', 'population with atrial fibrillation (AF']","['transthoracic echocardiography', 'Factor Xa Next Generation']","['Left atrial structure and function and the risk of death or heart failure', 'impaired LA function', 'risk for CV death or HF hospitalization', 'CV death or HF hospitalization', 'LA structure (LA volume index [LAVi]) and function (LA emptying fraction [LAEF] and LA expansion index [LAEi]) and risk for the composite endpoint of CV death or HF hospitalization, and its components', 'left atrial (LA) structure and function and the risk for cardiovascular (CV) death or heart failure (HF) hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0225860', 'cui_str': 'Left atrial structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0078994', 'cui_str': 'Atrial Function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",971.0,0.113759,"These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
","[{'ForeName': 'Riccardo M', 'Initials': 'RM', 'LastName': 'Inciardi', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1606']
1967,31797492,Less invasive ventricular reconstruction for ischaemic heart failure.,"AIMS


Surgical ventricular reconstruction to remodel, reshape, and reduce ventricular volume is an effective therapy in selected patients with chronic heart failure (HF) of ischaemic aetiology. The BioVentrix Revivent TC System offers efficacy comparable to conventional surgical ventricular reconstruction and is less invasive utilizing micro-anchor pairs to exclude scarred myocardium on the beating heart. Here, we present 12-months follow-up data of an international multicenter study.
METHODS AND RESULTS


Patients were considered eligible for the procedure when they presented with symptomatic HF [New York Heart Association (NYHA) class ≥II], left ventricular (LV) dilatation and dysfunction caused by myocardial infarction, and akinetic and/or dyskinetic transmural scarred myocardium located in the anteroseptal, anterolateral, and/or apical regions. A total of 89 patients were enrolled and 86 patients were successfully treated (97%). At 12 months, a significant improvement in LV ejection fraction (29 ± 8% vs. 34 ± 9%, P < 0.005) and a reduction of LV volumes was observed (LV end-systolic and end-diastolic volume index both decreased: 74 ± 28 mL/m 2  vs. 54 ± 23 mL/m 2  , P < 0.001; and 106 ± 33 mL/m 2  vs. 80 ± 26 mL/m 2  , respectively, P < 0.0001). Four patients (4.5%) died in hospital and survival at 12 months was 90.6%. At baseline, 59% of HF patients were in NYHA class III compared with 22% at 12-month follow-up. Improvements in quality of life measures (Minnesota Living with Heart Failure Questionnaire 39 vs. 26 points, P < 0.001) and 6-min walking test distance (363 m vs. 416 m, P = <0.001) were also significant.
CONCLUSIONS


Treatment with the Revivent TC System in patients with symptomatic HF results in significant and sustained reduction of LV volumes and improvement of LV function, symptoms, and quality of life.",2019,"Improvements in quality of life measures (Minnesota Living with Heart Failure Questionnaire 39 vs. 26 points, P < 0.001) and 6-min walking test distance (363 m vs. 416 m, P = <0.001) were also significant.
","['89 patients were enrolled and 86 patients were successfully treated (97', 'selected patients with chronic heart failure (HF) of ischaemic aetiology', 'Patients were considered eligible for the procedure when they presented with symptomatic HF [New York Heart Association (NYHA) class ≥II], left ventricular (LV) dilatation and dysfunction caused by myocardial infarction, and akinetic and/or dyskinetic transmural scarred myocardium located in the anteroseptal, anterolateral, and/or apical regions']",[],"['reduction of LV volumes', 'LV volumes and improvement of LV function, symptoms, and quality of life', 'died in hospital and survival', 'LV end-systolic and end-diastolic volume index', 'quality of life measures (Minnesota Living with Heart Failure Questionnaire', '6-min walking test distance', 'LV ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439842', 'cui_str': 'Dyskinetic'}, {'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],"[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0420302', 'cui_str': 'Died in hospital'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429925', 'cui_str': 'Test distance'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",89.0,0.0411446,"Improvements in quality of life measures (Minnesota Living with Heart Failure Questionnaire 39 vs. 26 points, P < 0.001) and 6-min walking test distance (363 m vs. 416 m, P = <0.001) were also significant.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'BIH Center for Regenerative Therapies (BCRT), Charité, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wechsler', 'Affiliation': 'Department of Cardiothoracic Surgery, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Skalsky', 'Affiliation': 'Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': 'Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Annest', 'Affiliation': 'BioVentrix, San Ramon, CA, USA.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bifi', 'Affiliation': 'Intituto di Cardiologia, Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': 'Department of Cardiology, Kings College Hospital, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Frerker', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Sievert', 'Affiliation': 'CardioVascular Center Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Demaria', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of California, Sulpizio Cardiovascular Center, San Diego, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kelle', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1669']
1968,31807782,Effects of High-Intensity Laser Therapy on Pain Sensitivity and Motor Performance in Patients with Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


To examine the effects of high-intensity laser therapy (HILT) on pain sensitivity and motor performance in patients with thumb carpometacarpal (CMC) osteoarthritis (OA).
DESIGN


Prospective, triple-blinded, randomized, placebo-controlled trial.
SETTING


Private practice, Malaga, Spain.
SUBJECTS


Forty-three patients (mean ± SD age = 71 ± 12 years) with a diagnosis of thumb CMC OA grade 1-2 were randomized to the control group (N = 21) or experimental group (N = 22).
METHODS


The experimental group (ExpG) received high-intensity laser therapy (HILT), and the control group (ConG) received a placebo treatment. The outcome measures were pain intensity (visual analog scale) and key pinch strength measurements (dynamometer). All outcome measures were collected at baseline, immediately following the intervention, at four weeks, and at 12 weeks following the intervention.
RESULTS


Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention. Although mean values in the ExpG were higher than in the ConG for key pinch at assessment, these differences were not statistically significant.
CONCLUSIONS


HILT effectively diminishes pain intensity when used as an isolated treatment for patients with thumb CMC OA, but the effect of treatment decreases after 12 weeks.",2020,"RESULTS


Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention.","['Patients with Thumb Carpometacarpal Joint Osteoarthritis', 'patients with thumb carpometacarpal (CMC) osteoarthritis (OA', 'Private practice, Malaga, Spain', 'patients with thumb CMC OA', 'Forty-three patients (mean ± SD age = 71\u2009±\u200912\u2009years) with a diagnosis of thumb CMC OA grade 1-2']","['placebo treatment', 'high-intensity laser therapy (HILT', 'High-Intensity Laser Therapy', 'placebo', 'high-intensity laser therapy (HILT), and the control group (ConG']","['pain sensitivity and motor performance', 'pain intensity (visual analog scale) and key pinch strength measurements (dynamometer', 'Pain Sensitivity and Motor Performance', 'pain intensity', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0224620', 'cui_str': 'Carpometacarpal joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0429272', 'cui_str': 'Key pinch'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.225699,"RESULTS


Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Cantero-Téllez', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Jorge Hugo', 'Initials': 'JH', 'LastName': 'Villafañe', 'Affiliation': 'Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Valdes', 'Affiliation': 'Departament of Ocupational Therapy, Gannon University, Ruskin, FL, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'García-Orza', 'Affiliation': 'Hospital Comarcal de la Axarquia, Malaga, Spain.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Bishop', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Medina-Porqueres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Malaga, Malaga, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz297']
1969,31880181,Effect of rational-emotive adult education intervention on burnout symptoms among primary school teachers in Southeast Nigeria.,"OBJECTIVE


To determine the effect of a rational-emotive adult education intervention (REAEI) on burnout symptoms among primary school teachers in Southeast Nigeria.
METHODS


Primary school teachers with burnout symptoms were randomised to treatment or control condition. Treatment was a 16-week REAEI programme delivered in 32 group therapeutic sessions. The Teachers' Burnout Inventory (TBI) score was recorded before and after therapy and at a three-month follow-up.
RESULTS


Overall, 27% (86/320) of the sample of primary school teachers had burnout symptoms. TBI scores were statistically significantly lower in the treatment group compared with the control group both after therapy and at the three- month follow up.
CONCLUSION


In this sample of primary school teachers, burnout symptoms were alleviated by use of a REAEI program.",2020,"TBI scores were statistically significantly lower in the treatment group compared with the control group both after therapy and at the three- month follow up.
","['Primary school teachers with burnout symptoms', 'primary school teachers in Southeast Nigeria']","['rational-emotive adult education intervention (REAEI', 'rational-emotive adult education intervention']","['TBI scores', ""Teachers' Burnout Inventory (TBI) score""]","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0424936', 'cui_str': 'Adult education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0193272,"TBI scores were statistically significantly lower in the treatment group compared with the control group both after therapy and at the three- month follow up.
","[{'ForeName': 'Linus Okechukwu', 'Initials': 'LO', 'LastName': 'Nwabuko', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Georgina Chinagorom', 'Initials': 'GC', 'LastName': 'Eze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Eberechukwu Charity', 'Initials': 'EC', 'LastName': 'Eneh', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Ann Ebere', 'Initials': 'AE', 'LastName': 'Okechukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Inwang Etim', 'Initials': 'IE', 'LastName': 'Udom', 'Affiliation': 'Department of Educational Foundations (Guidance and Counselling), University of Uyo, Uyo, Nigeria.'}]",The Journal of international medical research,['10.1177/0300060519882204']
1970,32236999,"Bacopa monnieri as augmentation therapy in the treatment of anhedonia, preclinical and clinical evaluation.","Bacopa monnieri (L.) is widely used in Ayurvedic medicine as a neural tonic for improving intelligence and memory. Several studies highlighted its efficacy in neuropsychiatric diseases but there is no evidence regarding anhedonia. Aim of the present work was to preclinically and clinically test against anhedonia a standardized B. monnieri extract (20% bacosides). In a mouse model of a depressive-like syndrome induced by lipopolysaccharide (LPS), the daily administration of the extract (50-200 mg kg -1  , p.o.) for 1 week, dose-dependently counteracted the immobility time in Porsolt and Tail suspension tests (p < .01). At the sucrose preference test (directly related to the ability for feeling pleasure) the extract treatment (100 and 200 mg kg -1  ) counteracted the reduction of sucrose intake induced by LPS (p < .01). Moreover, B. monnieri significantly reduced cytokines, cortisol, and artemin LPS-dependent alterations in plasma while increased the brain-derived neurotrophic factor levels (p < .05). The efficacy of the same extract was tested in a clinical study in which 42 patients with significant degree of anhedonia (evaluated as Snaith-Hamilton Pleasure Scale [SHAPS] score ≥ 3) were enrolled. Patients were divided into two groups and treated with citalopram or citalopram associated with B. monnieri (300 mg bid) for 4 weeks. The Pears Sample T-test showed a significant improvement (p < .05) in relevant scales (Hamilton depression rating scale, SHAPS, and strength and difficulties questionnaire) in the extract-treated group in comparison to citalopram alone was recorded. These data suggest that B. monnieri extract may be effective for the management of anhedonia and therefore should be considered for future controlled trials.",2020,"The Pears Sample T-test showed a significant improvement (p < .05) in relevant scales (Hamilton depression rating scale, SHAPS, and strength and difficulties questionnaire) in the extract-treated group in comparison to citalopram alone was recorded.",['42 patients with significant degree of anhedonia (evaluated as Snaith-Hamilton Pleasure Scale [SHAPS] score\u2009≥\u20093) were enrolled'],"['citalopram or citalopram associated with B. monnieri', 'lipopolysaccharide (LPS', 'citalopram']","['brain-derived neurotrophic factor levels', 'relevant scales (Hamilton depression rating scale, SHAPS, and strength and difficulties questionnaire', 'immobility time in Porsolt and Tail suspension tests', 'cytokines, cortisol, and artemin LPS-dependent alterations in plasma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0231441', 'cui_str': 'Immobile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376592', 'cui_str': 'Tail Suspension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",42.0,0.0254463,"The Pears Sample T-test showed a significant improvement (p < .05) in relevant scales (Hamilton depression rating scale, SHAPS, and strength and difficulties questionnaire) in the extract-treated group in comparison to citalopram alone was recorded.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Micheli', 'Affiliation': 'Department of Neuroscience, Psychology, Drug Research and Child Health-NEUROFARBA-Pharmacology and Toxicology Section, University of Florence, Florence, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Spitoni', 'Affiliation': 'Department Neurofarba, Psychiatry Section, University of Florence, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Di Cesare Mannelli', 'Affiliation': 'Department of Neuroscience, Psychology, Drug Research and Child Health-NEUROFARBA-Pharmacology and Toxicology Section, University of Florence, Florence, Italy.'}, {'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Bilia', 'Affiliation': 'Department of Chemistry ""Ugo Schiff"", University of Florence, Florence, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ghelardini', 'Affiliation': 'Department of Neuroscience, Psychology, Drug Research and Child Health-NEUROFARBA-Pharmacology and Toxicology Section, University of Florence, Florence, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pallanti', 'Affiliation': 'Department Neurofarba, Psychiatry Section, University of Florence, Florence, Italy.'}]",Phytotherapy research : PTR,['10.1002/ptr.6684']
1971,33119180,Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency.,"PURPOSE


To determine the effectiveness of office-based vergence/accommodative therapy for improving accommodative amplitude and accommodative facility in children with symptomatic convergence insufficiency and accommodative dysfunction.
METHODS


We report changes in accommodative function following therapy among participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline. The primary analysis compared mean change in amplitude and facility between the vergence/accommodative and placebo therapy groups using analyses of variance models after 4, 8, 12 and 16 weeks of treatment. The proportions of participants with normal amplitude and facility at each time point were calculated. The average rate of change in amplitude and facility from baseline to week 4, and from weeks 4 to 16, were determined in the vergence/accommodative therapy group.
RESULTS


From baseline to 16 weeks, the mean improvement in amplitude was 8.6 dioptres (D) and 5.2 D in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 3.5 D, 95% confidence interval (CI): 1.5 to 5.5 D; p = 0.01). The mean improvement in facility was 13.5 cycles per minute (cpm) and 7.6 cpm in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 5.8 cpm, 95% CI: 3.8 to 7.9 cpm; p < 0.0001). Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy. In the vergence/accommodative therapy group, amplitude increased at an average rate of 1.5 D per week during the first 4 weeks (p < 0.0001), then slowed to 0.2 D per week (p = 0.002) from weeks 4 to 16. Similarly, facility increased at an average rate of 1.5 cpm per week during the first 4 weeks (p < 0.0001), then slowed to 0.6 cpm per week from weeks 4 to 16 (p < 0.0001).
CONCLUSION


Office-based vergence/accommodative therapy is effective for improving accommodative function in children with symptomatic convergence insufficiency and coexisting accommodative dysfunction.",2020,"Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy.","['children with symptomatic convergence insufficiency and coexisting accommodative dysfunction', 'children with symptomatic convergence insufficiency and accommodative dysfunction', 'children with convergence insufficiency', 'participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline']","['vergence/accommodative therapy', 'placebo', 'office-based vergence/accommodative therapy', 'Office-based vergence/accommodative therapy']","['normal amplitude', 'average rate of change in amplitude and facility', 'mean improvement in facility', 'facility', 'accommodative amplitude and accommodative facility', 'accommodative function', 'mean change in amplitude and facility']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",115.0,0.155174,"Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy.","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Chen', 'Affiliation': 'Southern California College of Optometry, Marshall B Ketchum University, Fullerton, USA.'}, {'ForeName': 'Tawna L', 'Initials': 'TL', 'LastName': 'Roberts', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Stanford, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry, Marshall B Ketchum University, Fullerton, USA.'}, {'ForeName': 'Marjean T', 'Initials': 'MT', 'LastName': 'Kulp', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}, {'ForeName': 'Loraine T', 'Initials': 'LT', 'LastName': 'Sinnott', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Borsting', 'Affiliation': 'Southern California College of Optometry, Marshall B Ketchum University, Fullerton, USA.'}, {'ForeName': 'Yin C', 'Initials': 'YC', 'LastName': 'Tea', 'Affiliation': 'Nova Southeastern University, Fort Lauderdale, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jones-Jordan', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hertle', 'Affiliation': ""Akron Children's Hospital, Columbus, USA.""}, {'ForeName': 'G Lynn', 'Initials': 'GL', 'LastName': 'Mitchell', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eugene Arnold', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chase', 'Affiliation': 'Western University, Pomona, USA.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Scheiman', 'Affiliation': 'Salus University Pennsylvania College of Optometry, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12747']
1972,33124762,The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma.,"RATIONALE


Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once-daily ELLIPTA dry-powder inhaler (DPI) correctly, and who found it easy to use.
METHODS


This was a multicenter, single-arm, stratified, open-label, placebo study (NCT03478657). Children aged 5-7 and 8-11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28±2 days. On returning to the clinic, children were randomized to an age-appropriate, ease-of-use questionnaire that had been developed and validated previously, and which rated the inhaler as ""easy"" or ""hard"" to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease-of use were assessed in each age group (co-primary endpoints) and overall (secondary endpoints).
RESULTS


Of 222 enrolled children, 221 completed the study. Among children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared to 93% (n = 124/133) aged 8-11 years. Of these children, 98% (5-7 years: n = 79/81; 8-11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
CONCLUSIONS


ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training. This article is protected by copyright. All rights reserved.",2020,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
","['Of 222', 'children with asthma', 'children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared to 93% (n = 124/133) aged 8-11 years', 'Children aged 5-7 and 8-11 years', 'enrolled children, 221 completed the study']","['ELLIPTA DPI', 'placebo ELLIPTA DPI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],222.0,0.0380348,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Halverson', 'Affiliation': 'Allergy and Asthma, Minneapolis, Minnesota, US.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Liem', 'Affiliation': 'Joel Liem Medicine Professional Corporation, Windsor, ON, Canada.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Heyes', 'Affiliation': 'GlaxoSmithKline plc., Stockley Park, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'GlaxoSmithKline plc., Stockley Park, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bareille', 'Affiliation': 'GlaxoSmithKline plc., Stevenage, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'GlaxoSmithKline plc., Stockley Park, UK.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, North Carolina, US.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Stanford', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, North Carolina, US.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Lenney', 'Affiliation': 'GlaxoSmithKline plc., Brentford, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, North Carolina, US.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'GlaxoSmithKline plc., Brentford, London, UK.'}]",Pediatric pulmonology,['10.1002/ppul.25149']
1973,33124789,"Effect of core training on speed, quickness and agility in young male football players.","BACKGROUND


Core training effectively improves sport performance. The purpose of this study was to determine the effect of core training on the performance measures of speed, agility and quickness of U19 male football players.
METHODS


A total of 24 young male football players were divided into 12 in the experimental group (aged 18.17±0.72) and 12 in the control group (aged 18.31±0.75). The experimental group performed 30-35 min core training three days a week for eight weeks while the control group continued their routine training. Measurements included a 40-meter sprint test for speed, a hexagon test for quickness and an agility-T test for agility. Pre-test measurements at the start of the study and post-test measurements after eight weeks were compared by an ANOVA 2×2. A significant level of P<0.05 was established.
RESULTS


In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η<sup>2</sup>=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η<sup>2</sup>=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
CONCLUSIONS


The use of core training in combination with normal football training is shown to be effective in improving quickness and agility but not speed among young male football players after a period of eight weeks. So, it appears reasonable to include specific core training programs within football training.",2020,"In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η<sup>2</sup>=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η<sup>2</sup>=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
","['young male football players', '24 young male football players were divided into 12 in the experimental group (aged 18.17±0.72) and 12 in the control group (aged 18.31±0.75', 'U19 male football players']","['core training in combination with normal football training', 'core training', 'control group continued their routine training']","['speed, quickness and agility', 'sport performance', '40-meter sprint test for speed, a hexagon test for quickness and an agility-T test for agility. Pre-test measurements']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0408926,"In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η<sup>2</sup>=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η<sup>2</sup>=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Doğanay', 'Affiliation': 'Department of Sport Performance and Condition, Kocaeli University, Kocaeli, Turkey - muratdoganay41@gmail.com.'}, {'ForeName': 'Bergün M', 'Initials': 'BM', 'LastName': 'Bingül', 'Affiliation': 'Department of Sport Performance and Condition, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Álvarez-García', 'Affiliation': 'Department of Nursing, University of Jaén, Jaén, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10999-X']
1974,33124791,"Effects of exercise training and statin on hemodynamic, biochemical, inflammatory and immune profile of people living with HIV: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


The aim of this study is to evaluate the effect of exercise training (ET) and statins on the hemodynamic, biochemical, inflammatory and immune profile of people living with HIV (PLHIV).
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial in which 83 PLHIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET), or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. The PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, volunteers underwent blood collection to assess the biochemical, inflammatory, and immune profile.
RESULTS


There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure. The PLET and STAET groups had significantly (P<0.05) decreased systolic blood pressure, resting heart rate, fasting glucose, glycated hemoglobin, fasting insulin, homeostatic model assessment for insulin resistance, creatine kinase, lactate, and TNF-α levels, and increased adiponectin, CD4<sup>+</sup>, and CD8<sup>+</sup> levels. There was also a significant group effect (P<0.05) for CK levels among the exercised (PLET and STAET) and STA groups. The latter had a significant increase in fasting glucose (P<0.05) and creatine kinase (P<0.05).
CONCLUSIONS


ET improved the hemodynamic, biochemical, inflammatory, and immune profile of PLHIV and this effect was not dependent on the use of statins.",2020,There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure.,"['people living with HIV (PLHIV', 'people living with HIV', '83 PLHIV']","['exercise training (ET) and statins', 'STA', 'placebo (PL), statins (STA), placebo + ET (PLET), or statins + ET (STAET', 'rosuvastatin', 'placebo', 'exercise training and statin']","['CK levels', 'hemodynamic, biochemical, inflammatory and immune profile', 'systolic blood pressure, resting heart rate, fasting glucose, glycated hemoglobin, fasting insulin, homeostatic model assessment for insulin resistance, creatine kinase, lactate, and TNF-α levels, and increased adiponectin, CD4<sup>+</sup>, and CD8<sup>+</sup> levels', 'hemodynamic, biochemical, inflammatory, and immune profile of PLHIV', 'fasting glucose (P<0.05) and creatine kinase (P<0.05', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",83.0,0.327068,There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure.,"[{'ForeName': 'Hugo R', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'IMEPAC University Center, Araguari, Brazil - hugo.zanetti@hotmail.com.'}, {'ForeName': 'Edmar L', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'IMEPAC University Center, Araguari, Brazil.'}, {'ForeName': 'Leandro T', 'Initials': 'LT', 'LastName': 'Lopes', 'Affiliation': 'Brazil University, Fernandópolis, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Mário L', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Fernando F', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Elmiro S', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Federal University of Uberlândia, Uberlândia, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10838-7']
1975,33124792,Different types of functional training on the functionality and quality of life in postmenopausal women: a randomized and controlled trial.,"BACKGROUND


Physical exercise is widely recommended for improving physical fitness. However, the most effective training method in improving the daily life of postmenopausal women is not clear. Therefore, this study compares different ways of functional training, focused on the task, and directed to the physical abilities on the functionality and quality of life of the postmenopausal women.
METHODS


Forty-seven participants were randomly assigned into three groups: element-based functional training (EBFT); task-specific-based functional training (TSBFT); and the control group (CG). The intervention lasted fourteen weeks, with three weekly sessions stimulating several physical valences in the same session. The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
RESULTS


A similar increase was detected in both experimental groups for the variables-analyzed when compared to the initial moment (P<0.05), except in the dynamic postural control (P>0.05), which showed no difference. However, in the tests of rising from the floor and handgrip strength, only the task-specific-based functional training showed difference over time (P<0.05).
CONCLUSIONS


Functional training protocols improve the performance in daily activities of postmenopausal women. However, task-specific-based functional training is more effective when compared to the control group in the analyzed variables.",2020,"The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
","['Forty-seven participants', 'postmenopausal women']","['Physical exercise', 'functional training', 'element-based functional training (EBFT); task-specific-based functional training (TSBFT); and the control group (CG', 'Functional training protocols']","['functionality and quality of life', 'global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",47.0,0.02356,"The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Aragão-Santos', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil - carlosaragao.18@gmail.com.'}, {'ForeName': 'Antônio G', 'Initials': 'AG', 'LastName': 'de Resende-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10995-2']
1976,33124984,Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial.,"BACKGROUND


Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research.
OBJECTIVE


The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada.
METHODS


A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy.
RESULTS


A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (F 2,877 =0.85; P=.43, f=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (F 2,877 =23.52; P<.001, f=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, P<.001).
CONCLUSIONS


Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.6446.",2020,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","['students from three postsecondary institutions was conducted', 'A total of 481 students', 'Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device', 'postsecondary students in Canada', 'Mental Health Help-Seeking Among College and University Students']","['mental health services information pamphlet', 'Mobile and Web App (Thought Spot', 'Thought Spot app on their digital device']","['help-seeking intentions', 'formal help-seeking intentions', 'change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire', 'changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0682294', 'cui_str': 'Part-time employment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",481.0,0.160705,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wiljer', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Krembil Centre for Neuroinformatics, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Alexxa', 'Initials': 'A', 'LastName': 'Abi-Jaoudé', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Chaim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Robb', 'Affiliation': 'Health and Wellness, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Wong', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Aristotle', 'Initials': 'A', 'LastName': 'Voineskos', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/20790']
1977,33113528,Pellicle Modification with Casein and Mucin Does Not Affect Surface Loss from Erosion and Abrasion.,"AIM


A combination of the proteins casein and mucin is known to modify the salivary pellicle and improve its protection of the underlying enamel from erosion. It is so far not known if this protection is confined solely to erosion, or if it also extends to abrasion, and this in vitro study aimed at investigating this question.
METHODS


A total of 72 human enamel specimens were prepared and randomly assigned to four groups: pellicle (P), casein/mucin (CM), pellicle + casein/mucin (PCM), and control (Ctrl). Each specimen underwent five cycles, each cycle consisting of a pellicle/treatment part, an erosion part (3 min in 1% citric acid, pH 3.6, 25°C, 70 rpm), and an abrasion part (50 toothbrush strokes within 25 s in toothpaste slurry with a 200-g load). The pellicle/treatment part consisted of 2 h of incubation in whole human saliva for group P, 2 h of incubation (25°C, 70 rpm) in a protein mixture of 1% casein and 0.27% mucin for group CM, and 2 h of incubation in saliva followed by 2 h of incubation in the protein mixture for group PCM. The fourth group (Ctrl) served as the control and was kept in a humid chamber without saliva or protein treatment. The enamel surfaces were scanned with an optical profilometer initially and after the final cycle, and surface loss was analyzed. Furthermore, the surface microhardness (SMH) was measured initially, after each pellicle/treatment part and each erosion cycle, and after the final abrasion cycle. The results were analyzed with Kruskal-Wallis and Wilcoxon tests with Bonferroni corrections.
RESULTS


The different treatments did not show differences in surface loss and therefore did not protect enamel from surface loss by abrasion. Nonetheless, we observed differences in the SMH values, namely the Ctrl group being significantly softer than the experimental groups.
CONCLUSION


The observed differences in SMH suggest that a different abrasion protocol could lead to differences in surface loss, and further investigation of whether and under which conditions pellicle modification leads to increased resistance to abrasion remains worthwhile.",2020,The fourth group (Ctrl) served as the control and was kept in a humid chamber without saliva or protein treatment.,['72 human enamel specimens'],"['humid chamber without saliva or protein treatment', 'pellicle (P), casein/mucin (CM), pellicle + casein/mucin (PCM), and control (Ctrl', 'protein mixture of 1% casein and 0.27% mucin for group CM, and 2 h of incubation in saliva followed by 2 h of incubation in the protein mixture for group PCM', 'Casein and Mucin']","['SMH values', 'surface loss', 'surface microhardness (SMH']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.0446369,The fourth group (Ctrl) served as the control and was kept in a humid chamber without saliva or protein treatment.,"[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Baumann', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland, tommy.baumann@zmk.unibe.ch.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland.'}]",Caries research,['10.1159/000510699']
1978,33113535,The Degree of the Predischarge Pulmonary Congestion in Patients Hospitalized for Worsening Heart Failure Predicts Readmission and Mortality.,"BACKGROUND


Prediction of readmission and death after hospitalization for heart failure (HF) is an unmet need.
AIM


We evaluated the ability of clinical parameters, NT-proBNP level and noninvasive lung impedance (LI), to predict time to readmission (TTR) and time to death (TTD).
METHODS AND RESULTS


The present study is a post hoc analysis of the IMPEDANCE-HF extended trial comprising 290 patients with LVEF ≤45% and New York Heart Association functional class II-IV, randomized 1:1 to LI-guided or conventional therapy. Of all patients, 206 were admitted 766 times for HF during a follow-up of 57 ± 39 months. The normal LI (NLI), representing the ""dry"" lung status, was calculated for each patient at study entry. The current degree of pulmonary congestion (PC) compared with its dry status was represented by ΔLIR = ([measured LI/NLI] - 1) × 100%. Twenty-six parameters recorded during HF admission were used to predict TTR and TTD. To determine the parameter which mainly impacted TTR and TTD, variables were standardized, and effect size (ES) was calculated. Multivariate analysis by the Andersen-Gill model demonstrated that ΔLIRadmission (ES = 0.72), ΔLIRdischarge (ES = -3.14), group assignment (ES = 0.2), maximal troponin during HF admission (ES = 0.19), LVEF related to admission (ES = -0.22) and arterial hypertension (ES = 0.12) are independent predictors of TTR (p < 0.01, χ2 = 1,206). Analysis of ES showed that residual PC assessed by ∆LIRdischarge was the most prominent predictor of TTR. One percent improvement in predischarge PC, assessed by ∆LIRdischarge, was associated with a likelihood of TTR increase by 14% (hazard ratio [HR] 1.14, 95% confidence interval [CI] 1.13-1.15, p < 0.01) and TTD increase by 8% (HR 1.08, 95% CI 1.07-1.09, p < 0.01).
CONCLUSION


The degree of predischarge PC assessed by ∆LIR is the most dominant predictor of TTR and TTD.",2020,"Multivariate analysis by the Andersen-Gill model demonstrated that ΔLIRadmission (ES = 0.72), ΔLIRdischarge (ES = -3.14), group assignment (ES = 0.2), maximal troponin during HF admission (ES = 0.19), LVEF related to admission (ES = -0.22) and arterial hypertension (ES = 0.12) are independent predictors of TTR (p < 0.01, χ2 = 1,206).","['Of all patients, 206 were admitted 766 times for HF during a follow-up of 57 ± 39 months', 'Patients Hospitalized for Worsening Heart Failure Predicts Readmission and Mortality', '290 patients with LVEF ≤45% and New York Heart Association functional class II-IV']",['LI-guided or conventional therapy'],"['maximal troponin during HF admission', 'ability of clinical parameters, NT-proBNP level and noninvasive lung impedance (LI), to predict time to readmission (TTR) and time to death (TTD', 'predischarge PC', 'normal LI (NLI', 'pulmonary congestion (PC', 'TTD increase', 'arterial hypertension', 'likelihood of TTR increase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242073', 'cui_str': 'Pulmonary congestion'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",290.0,0.0493892,"Multivariate analysis by the Andersen-Gill model demonstrated that ΔLIRadmission (ES = 0.72), ΔLIRdischarge (ES = -3.14), group assignment (ES = 0.2), maximal troponin during HF admission (ES = 0.19), LVEF related to admission (ES = -0.22) and arterial hypertension (ES = 0.12) are independent predictors of TTR (p < 0.01, χ2 = 1,206).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kleiner-Shochat', 'Affiliation': 'Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel, shochat1@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kapustin', 'Affiliation': 'University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Department of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'The Permanente Medical Group, San Francisco, California, USA.'}, {'ForeName': 'Juliya', 'Initials': 'J', 'LastName': 'Glantz', 'Affiliation': 'Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kazatsker', 'Affiliation': 'Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Kleiner', 'Affiliation': 'Department of Cardiology, University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Weinstein', 'Affiliation': 'Department of Cardiology, University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Gurusher', 'Initials': 'G', 'LastName': 'Panjrath', 'Affiliation': 'Department of Medicine (Cardiology), George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Simcha R', 'Initials': 'SR', 'LastName': 'Meisel', 'Affiliation': 'Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel.'}]",Cardiology,['10.1159/000510073']
1979,33113567,Effects of switching from clopidogrel to prasugrel at the chronic phase after coronary stenting on antiplatelet action and vascular endothelial function: Switch-Pras study.,"Compared to clopidogrel, prasugrel has a lower incidence of ischemic events following percutaneous coronary intervention (PCI) because of an early reduction during the acute phase in P2Y12 reaction units (PRU). The objective of this study was to compare the antiplatelet effect and vascular endothelial function of both drugs during the chronic phase after PCI. Patients who had undergone PCI and were confirmed to have no restenosis by follow-up coronary angiography under dual anti-platelet therapy with clopidogrel (75 mg/day) and aspirin (100 mg/day) were randomized to either continue clopidogrel or switch to prasugrel (3.75 mg/day). At baseline, prior to randomization we determined the CYP2C19 genotype. At the baseline and 24 weeks after randomization, the P2Y12 reactivity unit (PRU) was measured using the VerifyNow™ P2Y12 assay. Endothelial function was evaluated by flow-mediated vasodilation (FMD) and reactive hyperemia peripheral arterial tonometry (RH-PAT), while and circulating CD34+/CD133+/CD45 low  progenitor cells were measured by flow cytometric analysis. Serum high-sensitivity C-reactive protein (hsCRP) level was also measured. The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001). This reduction was not observed in the clopidogrel group. The number of CD34+/CD133+/CD45 low  cells increased in the clopidogrel group (P = 0.008), but not in the prasugrel group. The hsCRP, FMD and reactive hyperemia index measured by RH-PAT did not change in either group. Prasugrel is potentially better than clopidogrel for preventing thrombotic events, although clopidogrel may have an advantage over prasugrel in terms of preventing atherosclerotic events. Proper use of thienopyridine drugs based on the CYP2C19 genotype has promising clinical potential.",2020,"The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001).",['Patients who had undergone PCI and were confirmed to have no restenosis by follow-up coronary angiography under dual anti-platelet therapy with'],"['percutaneous coronary intervention (PCI', 'continue clopidogrel or switch to prasugrel', 'clopidogrel', 'Prasugrel', 'aspirin', 'clopidogrel, prasugrel']","['Serum high-sensitivity C-reactive protein (hsCRP) level', 'hsCRP, FMD and reactive hyperemia index', 'P2Y12 reactivity unit (PRU', 'number of CD34+/CD133+/CD45 low  cells', 'Endothelial function', 'PRU', 'antiplatelet effect and vascular endothelial function', 'ischemic events', 'flow-mediated vasodilation (FMD) and reactive hyperemia peripheral arterial tonometry (RH-PAT), while and circulating CD34+/CD133+/CD45 low  progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C5197905', 'cui_str': 'Dual Anti-Platelet Therapy'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",,0.023463,"The PRU was reduced significantly in the prasugrel group (P = 0.0008), especially in patients who were intermediate or poor metabolizers based on the CYP2C19 genotype (P < 0.0001).","[{'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Masuyama', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan. masakuma@dokkyomed.ac.jp.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Waku', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hirose', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Kitahara', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Naganuma', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yazawa', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Shichiro', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Tochigi, 321-0293, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01714-w']
1980,33113886,Polyethylene Nail Brace for Ingrown Toenails Treatment: A Randomized Clinical Trial.,"Background:  Onychocryptosis is one of the most prevailing onychopathies and one of the usual reasons for visiting podiatry clinics. In this research, we aim to evaluate the effectiveness of a procedure of nail reeducation technique via a strip of polyethylene in subjects with stage I or IIa onychocryptosis, in which pathological toenail curves are present.  Methods:  This research was a randomized clinical trial (ACTRN12615000834550). The sample was made up of 94 cases of stage I or IIa onychocryptosis, according to the Mozena classification. Briefly, 46 cases were treated with the combination of a spicule technique and nail brace with a polyethylene plastic strip, and 48 were only treated with the spicule technique.  Results:  The combination of the spicule technique and the nail brace technique with a strip of polyethylene had a significantly lower recurrence rate compared to that achieved with just the spicule technique, twelve months after the beginning of the study (N.S. = 0.000 for α = 0.05). The change in the nail width achieved with the nail brace technique, twelve months after the beginning of the study, was statistically significant (N.S. = 0.000 for α = 0.05).  Conclusions:  The recurrence rate of the spicule technique alone was significantly higher than the combined technique of spicule with nail brace. A nail brace with a strip of polyethylene reduces the recurrence rate of onychocryptosis.",2020,The recurrence rate of the spicule technique alone was significantly higher than the combined technique of spicule with nail brace.,"['subjects with stage I or IIa onychocryptosis', 'Ingrown Toenails Treatment', '46 cases were treated with the combination of a']","['spicule technique and nail brace with a polyethylene plastic strip', 'nail reeducation technique via a strip of polyethylene', 'Polyethylene Nail Brace']","['nail width', 'recurrence rate', 'recurrence rate of onychocryptosis']","[{'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0027343', 'cui_str': 'Ingrowing nail'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027343', 'cui_str': 'Ingrowing nail'}]",46.0,0.0504606,The recurrence rate of the spicule technique alone was significantly higher than the combined technique of spicule with nail brace.,"[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Márquez-Reina', 'Affiliation': 'Nuestra Señora de la Oliva Foot Clinic, Bda. Ntra. Sra. de la Oliva Bq. 24, Bajo B, 41013 Sevilla, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Palomo-Toucedo', 'Affiliation': 'Departamento de Podologia, Universidad de Sevilla, Calle Avicena, s/n, 41009 Sevilla, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Reina-Bueno', 'Affiliation': 'Departamento de Podologia, Universidad de Sevilla, Calle Avicena, s/n, 41009 Sevilla, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Castillo-López', 'Affiliation': 'Departamento de Podologia, Universidad de Sevilla, Calle Avicena, s/n, 41009 Sevilla, Spain.'}, {'ForeName': 'Javier Ramos', 'Initials': 'JR', 'LastName': 'Ortega', 'Affiliation': 'Departamento de Podologia, Universidad de Sevilla, Calle Avicena, s/n, 41009 Sevilla, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podiatry, Universidade da Coruña, 15403 Ferrol, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Domínguez-Maldonado', 'Affiliation': 'Departamento de Podologia, Universidad de Sevilla, Calle Avicena, s/n, 41009 Sevilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17217741']
1981,33113896,Microbial Reference Frames Reveal Distinct Shifts in the Skin Microbiota after Cleansing.,"Skin cleansing represents a process of mechanical and chemical removal of dirt, pollutants as well as microbiota from the skin. While skin cleansing can help maintain good health, protect us from infections, illnesses and ailments, skin cleansing can also strip away lipids and moisture from the skin, leading to irritation, barrier impairment and disturbance of the delicate cutaneous microbiome. This study investigated how skin cleansing impacts skin's microbial composition. Thirty Caucasian women were enrolled in a placebo controlled clinical study where participants applied on their volar forearms a liquid body wash twice daily for 1 week in order to mimic frequent showering. Skin microbiome samples were collected by swabbing at defined timepoints and 16S rRNA sequencing was performed. Using ""reference frames"", we could identify shifts in the microbial composition and several microbiota were identified as being characteristically associated with the presence of saccharide isomerate, a well-known skin moisturizer. The microbial shift was quite immediate, and we could observe it already at 1 h post cleansing. Interestingly, the new microbial composition reached a certain dynamic equilibrium at day 1 which was then maintained until the end of the study.  Paracoccus marcusii , a potentially beneficial carotenoid-producer microorganism, was enriched by the active treatment and, at the same time, the abundance of several potential pathogenic taxa,  Brevibacterium casei  and  Rothia mucilaginosa,  diminished.",2020,"Using ""reference frames"", we could identify shifts in the microbial composition and several microbiota were identified as being characteristically associated with the presence of saccharide isomerate, a well-known skin moisturizer.",['Thirty Caucasian women'],"['Skin cleansing', 'placebo']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],30.0,0.0125324,"Using ""reference frames"", we could identify shifts in the microbial composition and several microbiota were identified as being characteristically associated with the presence of saccharide isomerate, a well-known skin moisturizer.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Sfriso', 'Affiliation': 'DSM Nutritional Products, Personal Care, Wurmisweg 576, CH-4303 Kaiseraugst, Switzerland.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Claypool', 'Affiliation': 'DSM Nutritional Products, Nutrition Innovation Center, Lexington, MA 02421, USA.'}]",Microorganisms,['10.3390/microorganisms8111634']
1982,33113956,"Effects of  Euglena gracilis  Intake on Mood and Autonomic Activity under Mental Workload, and Subjective Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial.","While the human body maintains homeostasis by altering the balance in the autonomic nervous, endocrine, and immune systems, a prolonged imbalance in these systems can result in physical and mental symptoms, including a decline in sleep quality and work efficiency.  Euglena   gracilis  ( Euglena ) is a single-celled microalga with the properties of both plants and animals and contains abundant nutrients, such as vitamins, minerals, amino acids, and fatty acids, which have various beneficial health effects. This study evaluated the effects of  Euglena  intake on the mood states and stress coping under mental workload tasks, and subjective sleep quality. We assigned men and women aged 20 to 64 years to  Euglena  and placebo intake groups, and measured indices related to the autonomic nervous system, psychological states, and sleep quality together with the application of workload stress before food intake, and 4, 8, and 12 weeks after commencing intake.  Euglena  intake regulated the autonomic nervous system under a workload and improved psychological parameters and sleep conditions. These results indicate that the consumption of  Euglena  may regulate the balance of the autonomic nervous system during stress and may have a favorable effect on psychological status and sleep quality.",2020,Euglena  intake regulated the autonomic nervous system under a workload and improved psychological parameters and sleep conditions.,"['men and women aged 20 to 64 years to  Euglena  and placebo intake groups, and measured indices related to the autonomic nervous system, psychological states, and sleep quality together with the application of workload stress before food intake, and 4, 8, and 12 weeks after commencing intake']","['Euglena  intake', 'Placebo', 'Euglena gracilis  Intake']","['psychological status and sleep quality', 'mood states and stress coping under mental workload tasks, and subjective sleep quality', 'psychological parameters and sleep conditions', 'Mood and Autonomic Activity under Mental Workload, and Subjective Sleep Quality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015154', 'cui_str': 'Euglena'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015154', 'cui_str': 'Euglena'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015155', 'cui_str': 'Euglena gracilis'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0465337,Euglena  intake regulated the autonomic nervous system under a workload and improved psychological parameters and sleep conditions.,"[{'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Euglena Co., Ltd., Tokyo 108-0014, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Yasuda', 'Affiliation': 'Euglena Co., Ltd., Tokyo 108-0014, Japan.'}, {'ForeName': 'Ako', 'Initials': 'A', 'LastName': 'Murata', 'Affiliation': 'Euglena Co., Ltd., Tokyo 108-0014, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Euglena Co., Ltd., Tokyo 108-0014, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Miura', 'Affiliation': 'Miura Clinic, Medical Corporation Kanonkai, Osaka 530-0044, Japan.'}]",Nutrients,['10.3390/nu12113243']
1983,33113962,The Impact of Obesity on Left Ventricular Assist Device Outcomes.,"Background and Objectives : The understanding of high body mass index (BMI) and outcomes after Left Ventricular Assist Device (LVAD) implantation continues to evolve and the relationship has not been established yet. In this study, we investigated the effects of obesity (BMI > 30 kg/m 2 ) on post-LVAD implantation outcomes. HeartWare LVAD and Heart Mate III LVAD were implanted. The primary outcome that was measured was mortality (in-hospital and on follow-up). The secondary outcomes that were measured were major adverse events.  Materials and Methods :  At our institution, the West German Heart and Vascular Center (Essen, Germany), from August 2010 to January 2020, a total of 210 patients received a long-term LVAD. Patients were stratified according to BMI ≥ 30 kg/m 2  representing the obesity threshold. The first group ( n  = 162) had an average BMI of 24.2 kg/m 2  (±2.9), and the second group ( n  = 48) had an average BMI of 33.9 kg/m 2  (±3.2). Baseline demographics were analysed alongside comorbidities per group.  Results:  Overall mortality was not significantly different between the obese group (51.1%  n  = 24) and the nonobese group (55.2%,  n  = 85) ( p  = 0.619). The difference between the mean duration of survival of patients who expired after hospital discharge was insignificant (2.1 years ± 1.6, group 1; 2.6 years ± 1.5, group 2;  p  = 0.29). In-hospital mortality was unvaried between the two groups: group 1:  n  = 34 (44% out of overall group 1 deaths); group 2:  n  = 11 (45.8% out of overall group 2 deaths) ( p  > 0.05). Postoperative complications were unvaried between the obese and the non-obese group (all with  p  > 0.05). However, a significant difference was found with regards to follow-up neurological complications (18.5% vs. 37.8%,  p  = 0.01) and LVAD thrombosis (14.7% vs. 33.3%,  p  = 0.01), as both were higher in the obese population.  Conclusion:  Obesity does not form a barrier for LVAD implantation in terms of mortality (in-hospital and on follow up). However, a significantly higher incidence of follow-up LVAD thrombosis and neurological complications has been found in the obese group of patients.",2020,Postoperative complications were unvaried between the obese and the non-obese group (all with  p  > 0.05).,"['Patients were stratified according to BMI ≥ 30 kg/m 2  representing the obesity threshold', 'At our institution, the West German Heart and Vascular Center (Essen, Germany), from August 2010 to January 2020, a total of 210 patients received a']","['Left Ventricular Assist Device (LVAD) implantation', 'long-term LVAD']","['Overall mortality', 'Postoperative complications', 'hospital mortality', 'neurological complications', 'mean duration of survival', 'HeartWare LVAD and Heart Mate III LVAD', 'mortality (in-hospital and on follow-up', 'LVAD thrombosis', 'major adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",210.0,0.0806855,Postoperative complications were unvaried between the obese and the non-obese group (all with  p  > 0.05).,"[{'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zhigalov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Michel Pompeu Barros Oliveira', 'Initials': 'MPBO', 'LastName': 'Sá', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), 26133 Oldenburg, Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Arjomandi Rad', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), 26133 Oldenburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vardanyan', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), 26133 Oldenburg, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Goerdt', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chrosch', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Zubarevich', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Pizanis', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kamler', 'Affiliation': 'Department of Cardiothoracic Surgery, Heart Center Essen Huttrop, University Hospital Essen, 45138 Essen, Germany.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Medical Centre Tubingen, 72076 Tubingen, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schmack', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Arjang', 'Initials': 'A', 'LastName': 'Ruhparwar', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Aron-Frederik', 'Initials': 'AF', 'LastName': 'Popov', 'Affiliation': 'International Thoracic and Cardiovascular Research Association (ITCVR), 26133 Oldenburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weymann', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital of Essen, University Duisburg-Essen, 45122 Essen, Germany.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110556']
1984,33114121,Oral Treatment of Central Serous Chorioretinopathy Patients Using Propranolol Tablets.,"PURPOSE


To evaluate the pharmacological effects of propranolol treatment of patients with central serous chorioretinopathy (CSCR) over 4 months.
RESULTS


Among the 89 male and 31 female patients, the mean BCVA decreased to 0.42 ± 0.08 logMAR during CSCR attacks. Oral propranolol showed good effectiveness in reducing CSCR signs after at least 4 months of treatment. The final BCVA of the patients in groups 1 and 2 was 0.09 ± 0.01 and 0.19 ± 0.03 logMAR, respectively ( p  < 0.05). Moreover, the mean complete remission time in groups 1 and 2 was 1.9 and 3.5 months, respectively ( p  < 0.05), while the ""success"" rate in groups 1 and 2 was 95.0% (57/60) and 78.3% (47/60), respectively ( p  < 0.05). The recurrence rate in groups 1 and 2 was 5.3% (3/57) and 25.5% (12/47) after a further 5 months of follow-up, respectively ( p  < 0.05).
MATERIALS AND METHODS


One hundred and twenty patients were enrolled and randomly divided into two groups that both underwent a visual acuity test and optical coherence tomography (OCT) scanning, between April and December 2017. The 60 patients in group 1 were requested to take propranolol for 4 months, while the other 60 subjects (group 2) received placebo therapy during the same period. The best-corrected visual acuity (BCVA) of every volunteer and an OCT image of each patient were checked and recorded at the beginning of the study and each week thereafter. If the signs of CSCR disappeared completely from the OCT scans, the case was considered a ""success"" and treatment stopped at once. However, the ""success"" subjects were further evaluated in follow-ups throughout the next 5 months to determine the rate of recurrence in groups 1 and 2. The time of total complete remission of CSCR from the OCT scans was also measured in groups 1 and 2.
CONCLUSION


CSCR patients revealed an excellent prognosis and success rate of 95.0% after taking propranolol. The treatment was able to enhance subretinal fluid (SRF) absorption, shorten the time to total complete remission, and significantly decrease CSCR recurrence. As such, we suggest that taking propranolol may be an alternative and viable choice for CSCR patients, given that the new method was shown to be safe, cheap, effective, well tolerated and convenient.",2020,"The treatment was able to enhance subretinal fluid (SRF) absorption, shorten the time to total complete remission, and significantly decrease CSCR recurrence.","['60 patients in group 1 were requested to take', 'Central Serous Chorioretinopathy Patients Using', 'patients with central serous chorioretinopathy (CSCR) over 4 months', '89 male and 31 female patients', 'One hundred and twenty patients', 'CSCR patients']","['visual acuity test and optical coherence tomography (OCT) scanning', 'propranolol', 'placebo therapy', 'Oral propranolol', 'Propranolol Tablets']","['CSCR recurrence', 'mean BCVA', 'subretinal fluid (SRF) absorption, shorten the time to total complete remission', 'mean complete remission time', 'time of total complete remission of CSCR', 'best-corrected visual acuity (BCVA', 'rate of recurrence', 'excellent prognosis and success rate', 'recurrence rate', 'CSCR signs', 'success"" rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",120.0,0.0224753,"The treatment was able to enhance subretinal fluid (SRF) absorption, shorten the time to total complete remission, and significantly decrease CSCR recurrence.","[{'ForeName': 'Li-Chai', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Tajen University, Pingtung 907, Taiwan.'}, {'ForeName': 'Jui-Wen', 'Initials': 'JW', 'LastName': 'Ma', 'Affiliation': 'Department of Pharmacy, Tajen University, Pingtung 907, Taiwan.'}, {'ForeName': 'Po-Chuen', 'Initials': 'PC', 'LastName': 'Shieh', 'Affiliation': 'Department of Pharmacy, Tajen University, Pingtung 907, Taiwan.'}, {'ForeName': 'Chi-Ting', 'Initials': 'CT', 'LastName': 'Horng', 'Affiliation': 'Department of Pharmacy, Tajen University, Pingtung 907, Taiwan.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13110336']
1985,33114125,Bioavailability of Orally Administered Active Lipid Compounds from four Different Greenshell™ Mussel Formats.,"Greenshell™ mussel (GSM,  Perna canaliculus ) is New Zealand's most important aquaculture species. They are a good source of long chain-polyunsaturated fatty acids ( n -3 LC PUFA). Beyond a traditional food product, GSMs are also sold as mussel powders and oil extract formats in the nutraceutical markets. In this study, a four-sequence, single dose, randomized crossover human trial with eight evaluable healthy male participants was undertaken to determine the bioavailability of the  n -3 LC PUFA in four different GSM formats (oil, powder, food ingredient and half-shell unprocessed whole mussel) by measuring area under the curve (AUC) and maximal concentration (C Max ). Blood samples were collected at baseline and up to 48 h after initiation of product consumption in each administration period. There were minor differences between the bioavailability of FA (fatty acid) between the different GSM formats. Eicosapentaenoic acid (EPA) peak concentrations and plasma exposures were significantly lower with GSM oil compared to GSM half-shell and GSM powder formats, which resulted in AUC 0-48  for the intake of GSM half-shell mussel and GSM powder being significantly higher than that for GSM oil ( p  = 0.013,  f = 4.84). This equated to a 20.6% and 24.3% increase in the amount of EPA present in the plasma after consumption of half-shell mussels and mussel powder respectively compared to GSM oil. GSM oil produced the shortest median time to maximal plasma  n -3 LC PUFA concentration of all evaluated products demonstrated by a shorter maximum measured plasma concentration (T Max  = 5 h). Docosahexaenoic acid (DHA) and  n -3 LC PUFA plasma exposure parameters were statistically comparable across the four GSM products evaluated.",2020,GSM oil produced the shortest median time to maximal plasma  n -3 LC PUFA concentration of all evaluated products demonstrated by a shorter maximum measured plasma concentration (T Max  = 5 h).,['eight evaluable healthy male participants'],"['Eicosapentaenoic acid (EPA', 'GSM oil']","['bioavailability of FA (fatty acid', 'shortest median time to maximal plasma  n -3 LC PUFA concentration', 'Bioavailability', 'Blood samples', 'peak concentrations and plasma exposures', 'measuring area under the curve (AUC) and maximal concentration (C Max ', 'Docosahexaenoic acid (DHA) and  n -3 LC PUFA plasma exposure parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8.0,0.0492592,GSM oil produced the shortest median time to maximal plasma  n -3 LC PUFA concentration of all evaluated products demonstrated by a shorter maximum measured plasma concentration (T Max  = 5 h).,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Miller', 'Affiliation': 'Cawthron Institute, 98 Halifax Street East, Nelson 7010, New Zealand.'}, {'ForeName': 'Marlena C', 'Initials': 'MC', 'LastName': 'Kruger', 'Affiliation': 'School of Health Sciences, College of Health, Massey University, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wynne', 'Affiliation': 'Christchurch Clinical Studies Trust (CSST), Christchurch Central, Christchurch 8011, New Zealand.'}, {'ForeName': 'Devonie', 'Initials': 'D', 'LastName': 'Waaka', 'Affiliation': 'Christchurch Clinical Studies Trust (CSST), Christchurch Central, Christchurch 8011, New Zealand.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Science and Nutrition, Faculty of Medicine, Dentistry and Life Sciences, University of Chester, Chester CH1 4BJ, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Fran M', 'Initials': 'FM', 'LastName': 'Wolber', 'Affiliation': 'School of Food and Advanced Technology, College of Sciences, Massey University, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Eason', 'Affiliation': 'Cawthron Institute, 98 Halifax Street East, Nelson 7010, New Zealand.'}]",Marine drugs,['10.3390/md18110524']
1986,33114131,Effect of Bright Light Therapy on Depressive Symptoms in Middle-Aged and Older Patients Receiving Long-Term Hemodialysis.,"Depressive symptoms are common psychiatric comorbidities among individuals receiving long-term hemodialysis. The aim of this two-arm parallel design study is to assess the effects of bright light therapy (BLT) on depressive symptoms among middle-aged and older adults receiving long-term hemodialysis. Study participants are recruited using convenient sampling from four dialysis clinics in eastern Taiwan. The eligible participants are block-randomized to either the BLT group (n = 30), with 30 min sessions of BLT five times a week for six weeks at their own home, or to the routine care control group (n = 30). The Beck Depression Inventory-II (BDI-II) scores and the salivary cortisol levels are obtained from the participants at three time points: baseline (T 0 ), week 3 (T 1 ), and week 6 (T 2 ). The results, from the generalized estimating equations, indicate that the decline in the BDI-II scores over time is significant in the BLT group at T 1  (β = -7.57,  p  < 0.001) and at T 2  (β = -6.20,  p  = 0.002) compared to the control group. The decrease in salivary cortisol levels at each visit is also significant in the BLT group at T 1  (β = -7.37,  p  = 0.017) and at T 2  (β = -12.22,  p  = 0.005) compared to the control group. Our findings support the hypothesis that a six-week program of BLT is able to alleviate depressive symptoms in middle-aged and older patients who receive long-term hemodialysis.",2020,"The decrease in salivary cortisol levels at each visit is also significant in the BLT group at T 1  (β = -7.37,  p  = 0.017) and at T 2  (β = -12.22,  p  = 0.005) compared to the control group.","['Middle-Aged and Older Patients Receiving Long-Term Hemodialysis', 'individuals receiving long-term hemodialysis', 'middle-aged and older adults receiving long-term hemodialysis', 'Study participants are recruited using convenient sampling from four dialysis clinics in eastern Taiwan', 'middle-aged and older patients who receive long-term hemodialysis']","['bright light therapy (BLT', 'Bright Light Therapy', 'BLT']","['salivary cortisol levels', 'depressive symptoms', 'Depressive Symptoms', 'BDI-II scores over time', 'Beck Depression Inventory-II (BDI-II) scores and the salivary cortisol levels', 'Depressive symptoms']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4273555', 'cui_str': 'Beck Depression Inventory II score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0195613,"The decrease in salivary cortisol levels at each visit is also significant in the BLT group at T 1  (β = -7.37,  p  = 0.017) and at T 2  (β = -12.22,  p  = 0.005) compared to the control group.","[{'ForeName': 'Shu-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien City, Hualien 970301, Taiwan.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Graduate Institute of Long-term Care, Tzu Chi University of Science and Technology, Hualien City, Hualien 973046, Taiwan.'}, {'ForeName': 'Tsung-Cheng', 'Initials': 'TC', 'LastName': 'Hsieh', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien City, Hualien 970301, Taiwan.'}, {'ForeName': 'Ru-Ping', 'Initials': 'RP', 'LastName': 'Lee', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien City, Hualien 970301, Taiwan.'}, {'ForeName': 'Huei-Chuan', 'Initials': 'HC', 'LastName': 'Sung', 'Affiliation': 'Institute of Medical Sciences, Tzu Chi University, Hualien City, Hualien 970301, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17217763']
1987,33114145,"Short Bouts of Physical Activity Are Associated with Reduced Smoking Withdrawal Symptoms, but Perceptions of Intensity May Be the Key.","The primary aim of this study was to assess the effectiveness of a short bout (10 min) of moderate-intensity exercise to reduce withdrawal symptomatology, craving and negative affect; while the secondary aim was to assess how the effectiveness of a short bout of moderate exercise can be modulated by the perception of intensity in physically active and low-activity smokers. Fifty low-activity and physically active smokers were recruited (24 male and 26 female) and randomized in three different conditions. Prescribed (objective) moderate intensity (OBJ) and perceived moderate intensity (PER), and passive waiting (PW). After the intervention (T3), smokers reported less desire to smoke in the PER (p < 0.001) and OBJ (p < 0.001) conditions, relative to the PW condition. At T3 smokers in the PER condition reported less negative affect than smokers in the PW condition relative to the baseline (T1) (p < 0.007). Further, smokers in the PER condition reported less negative affect than smokers in the PW condition (p < 0.048). Physically active (PA) smokers perceived less exertion than low-activity (LA) smokers, and the effects were stronger in the PER condition relative to OBJ. Generally, our results suggest that a short bout of moderate exercise helps both LA and PA smokers. These findings provided a novel insight into the psychological mechanisms that affect the efficacy of the exercise in smoking cessation and suggest that exercise should be tailored according to individual perception of intensity.",2020,"Further, smokers in the PER condition reported less negative affect than smokers in the PW condition (p < 0.048).","['Fifty low-activity and physically active smokers were recruited (24 male and 26 female', 'physically active and low-activity smokers']",['short bout (10 min) of moderate-intensity exercise'],"['OBJ', 'Prescribed (objective) moderate intensity (OBJ) and perceived moderate intensity (PER), and passive waiting (PW']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",50.0,0.0260605,"Further, smokers in the PER condition reported less negative affect than smokers in the PW condition (p < 0.048).","[{'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Masiero', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Keyworth', 'Affiliation': 'School of Biosciences & Medicine, Faculty of Health and Medical Sciences, University of Surrey, Surrey GU2 7XH, UK.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cropley', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Surrey GU2 7YH, UK.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'School of Biosciences & Medicine, Faculty of Health and Medical Sciences, University of Surrey, Surrey GU2 7XH, UK.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040425']
1988,33115312,Efficacy of psychological intervention for patients with psoriasis vulgaris: a prospective study.,"OBJECTIVE


The study aim was to examine the effect of a psychological intervention on patients with psoriasis vulgaris.
METHODS


Participants in this prospective study were 205 patients with psoriasis vulgaris, 104 who received a psychological intervention (study group) and 101 who received routine nursing care (control group). An additional 291 healthy subjects formed a non-psoriasis group. The Symptom Checklist-90 (SCL-90), Generic Quality of Life Inventory (GQOLI), Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS) were used to evaluate psychological status and quality of life.
RESULTS


There were significant differences in SCL-90 and GQOLI scores between the study and non-psoriasis groups. After treatment, the study group showed significantly improved scores on the SCL-90 and GQOLI compared with the control group. Scores on the SDS (mean ± standard deviation: 31.99 ± 4.54 vs. 44.08 ± 4.52) and SAS (28.36 ± 4.52 vs. 40.14 ± 6.33) were improved in the study group. In addition, patients in the study group showed higher satisfaction rate and compliance rate than those in the control group.
CONCLUSION


Psychological intervention may be beneficial for improving quality of life and the therapeutic efficacy of drugs in patients with psoriasis.",2020,"After treatment, the study group showed significantly improved scores on the SCL-90 and GQOLI compared with the control group.","['Participants in this prospective study were 205 patients with psoriasis vulgaris, 104 who received a', 'patients with psoriasis', '291 healthy subjects formed a non-psoriasis group', 'patients with psoriasis vulgaris', 'study group) and 101 who received']","['psychological intervention', 'routine nursing care (control group', 'Psychological intervention']","['Symptom Checklist-90 (SCL-90), Generic Quality of Life Inventory', 'satisfaction rate and compliance rate', 'SCL-90 and GQOLI scores', 'GQOLI), Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS', 'psychological status and quality of life', 'SCL-90 and GQOLI', 'quality of life']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",205.0,0.0183098,"After treatment, the study group showed significantly improved scores on the SCL-90 and GQOLI compared with the control group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, the Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, The School Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, the Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, the Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}]",The Journal of international medical research,['10.1177/0300060520961674']
1989,33115319,Effect of 12 weeks of resistance training on motor coordination and dynamic balance of older woman.,"Resistance training is considered a viable strategy to enhance the autonomy and functionality of older populations. We randomized 49 older women (64.2 ± 3.8) into one of two groups: an intervention group (n=29) that performed regimented resistance training or a non-training control group (n=20). The resistance training protocol was carried out three times a week for both the upper and lower limbs over a 12-week study period. A 30-second arm flexion test was used to test upper limb endurance and a 30-second chair stand test was used to analyze lower limb endurance. Dynamic balance was tested via a Y balance test normalized by leg length. A Soda Pop test was employed to analyze coordination. Results showed significant improvements in intervention group vs. control group in both upper limb (19.50 ± 1.52 vs. 11.40 ± 2.87, p = 0.001) and lower limb muscular endurance (14.90 ± 3.10 vs. 26.56 ± 3.17, p=0.001). Moreover, the training group showed superior improvements in anterior and posterolateral balance compared to control group (63.9 ± 3.1% to 70.2 ± 2.1 and 88.1 ± 3.9 to 94.2 ± 2.7 with p=0.001, respectively). There were no significant differences in coordination outcomes between groups. In conclusion, we demonstrate that resistance training is effective in developing muscular endurance and dynamic balance in postmenopausal women, but does not influence muscular coordination in the measures studied.",2020,"Results showed significant improvements in intervention group vs. control group in both upper limb (19.50 ± 1.52 vs. 11.40 ± 2.87, p = 0.001) and lower limb muscular endurance (14.90 ± 3.10 vs. 26.56 ± 3.17, p=0.001).","['older woman', '49 older women (64.2 ± 3.8) into one of two groups: an intervention group (n=29) that performed', 'postmenopausal women']","['Resistance training', 'resistance training', 'regimented resistance training or a non-training control group']","['coordination outcomes', 'Dynamic balance', 'lower limb muscular endurance', 'muscular endurance and dynamic balance', 'motor coordination and dynamic balance', 'superior improvements in anterior and posterolateral balance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}]",49.0,0.0175174,"Results showed significant improvements in intervention group vs. control group in both upper limb (19.50 ± 1.52 vs. 11.40 ± 2.87, p = 0.001) and lower limb muscular endurance (14.90 ± 3.10 vs. 26.56 ± 3.17, p=0.001).","[{'ForeName': 'Luis Henrique Boiko', 'Initials': 'LHB', 'LastName': 'Ferreira', 'Affiliation': 'UFPR, 28122, Physical Education, Rua Coração de Maria, 82, Jardim Botânico, Curitiba, Paraná, Curitiba, Brazil, 80060-000; lhboikoferreira@gmail.com.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Jon Schoenfeld', 'Affiliation': 'Lehman College of CUNY Department of Health Sciences, 207083, Bronx, New York, United States; bradschoenfeldphd@gmail.com.'}, {'ForeName': 'Andre Camargo', 'Initials': 'AC', 'LastName': 'Smolarek', 'Affiliation': 'UFPR, 28122, Physical Education, Curitiba, PR, Brazil; andrecsk@gmail.com.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'McAnulty', 'Affiliation': 'Appalachian State University Beaver College of Health Sciences, 539559, Boone, North Carolina, United States; mcanltysr@appstate.edu.'}, {'ForeName': 'Luis Paulo Gomes', 'Initials': 'LPG', 'LastName': 'Mascarenhas', 'Affiliation': 'UNICENTRO, 307046, Physical Education, Guarapuava, PR, Brazil; luismsk@gmail.com.'}, {'ForeName': 'Tácito Pessoa', 'Initials': 'TP', 'LastName': 'Souza Junior', 'Affiliation': 'UFPR, 28122, Physical Education , Curitiba, PR, Brazil; tacitojr@me.com.'}]",Rejuvenation research,['10.1089/rej.2020.2339']
1990,33115322,Effects of Self-selected Resistance Training on Physical Fitness and Psychophysiological Responses in Physically Inactive Older Women: A Randomized Controlled Study.,"This study aimed to investigate the effects of a 12-week self-selected resistance training (SSRT) program on physical fitness and psychophysiological responses among physically inactive older women. We randomly allocated 32 inactive older women  (M  age = 66.0 years,  SD  = 3.0) into either an SSRT (n = 16) or control group (n = 16). Participants performed SSRT three times per week over 12 weeks. We assessed maximal isotonic and isokinetic muscle strength, functional capacity, flexibility, cardiorespiratory fitness, and body composition at baseline and after the intervention. Affective responses and perceived exertion were evaluated after each exercise set throughout the training program. The SSRT group significantly improved their maximal muscle strength in all exercises (Cohen's d ranging from 1.4-3.3; all  p's  < .001), peak torque (knee flexors: d = 1.7; knee extensors: d = 1.6; all  p  < .001), flexibility (knee flexors: d = 1.7; single hip flexors: d = 1.6; all  p  < .001; bilateral hip flexors: d = 1.1,  p  = .001), fat-free mass (d = .9,  p  = .008), and cardiorespiratory fitness (d = .9,  p  = .014), compared to the control group. All components of functional capacity improved compared to the control group (Cohen's d ranging from .8 to 5.5; all  p's  ≤ .001). Participants perceived the exercise training sessions as pleasant and of low to moderate effort. Thus, a 12-week SSRT program was effective at improving physical fitness and inducing feelings of pleasure among inactive older women.",2020,"The SSRT group significantly improved their maximal muscle strength in all exercises (Cohen's d ranging from 1.4-3.3; all  p's  < .001), peak torque (knee flexors: d = 1.7; knee extensors: d = 1.6; all  p  < .001), flexibility (knee flexors: d = 1.7; single hip flexors: d = 1.6; all  p  < .001; bilateral hip flexors: d = 1.1,  p  = .001), fat-free mass (d = .9,  p  = .008), and cardiorespiratory fitness (d = .9,  p  = .014), compared to the control group.","['inactive older women', 'Physically Inactive Older Women', '32 inactive older women  (M  age\u2009=\u200966.0 years,  SD \u2009=\u20093.0) into either an', 'physically inactive older women']","['SSRT', 'self-selected resistance training (SSRT) program', 'Self-selected Resistance Training', 'exercise training sessions']","['maximal muscle strength', 'flexibility', 'cardiorespiratory fitness', 'physical fitness and psychophysiological responses', 'peak torque', 'Physical Fitness and Psychophysiological Responses', 'Affective responses and perceived exertion', 'fat-free mass', 'maximal isotonic and isokinetic muscle strength, functional capacity, flexibility, cardiorespiratory fitness, and body composition', 'physical fitness and inducing feelings of pleasure', 'functional capacity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",32.0,0.0106457,"The SSRT group significantly improved their maximal muscle strength in all exercises (Cohen's d ranging from 1.4-3.3; all  p's  < .001), peak torque (knee flexors: d = 1.7; knee extensors: d = 1.6; all  p  < .001), flexibility (knee flexors: d = 1.7; single hip flexors: d = 1.6; all  p  < .001; bilateral hip flexors: d = 1.1,  p  = .001), fat-free mass (d = .9,  p  = .008), and cardiorespiratory fitness (d = .9,  p  = .014), compared to the control group.","[{'ForeName': 'Hassan Mohamed', 'Initials': 'HM', 'LastName': 'Elsangedy', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Gledson Tavares Amorim', 'Initials': 'GTA', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Daniel Gomes da Silva', 'Initials': 'DGDS', 'LastName': 'Machado', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Marília Padilha Martins', 'Initials': 'MPM', 'LastName': 'Tavares', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Andressa de Oliveira', 'Initials': 'AO', 'LastName': 'Araújo', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Kleverton', 'Initials': 'K', 'LastName': 'Krinski', 'Affiliation': 'Graduate Program in Collective Health, Federal University of Rio Grande do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Rodrigo Alberto Vieira', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Gregório da Silva', 'Affiliation': 'Department of Physical Education, State University of Northern Paraná, Jacarezinho, Brazil.'}]",Perceptual and motor skills,['10.1177/0031512520967610']
1991,33115345,Predicting Post-Concussion Symptom Recovery in Adolescents Using a Novel AI.,"This pilot study explores the possibility of predicting post-concussion symptom recovery at one week post-injury using only objective diffusion tensor imaging (DTI) data inputs to a novel artificial intelligence (AI) system composed of Genetic Fuzzy Trees (GFT). Forty-three adolescents age 11 to 16 years with either mild traumatic brain injury or traumatic orthopedic injury were enrolled upon presentation to the emergency department. Participants received a DTI scan three days post-injury and their symptoms were assessed by the Post-Concussion Symptom Scale (PCSS) at six hours and one week post-injury. The GFT system was trained using 1-week total PCSS scores, 48 volumetric MRI inputs and 192 DTI inputs per participant over 225 training runs. Each training run contained a randomly selected 80% of the total sample followed by a 20% validation run. Over a different randomly selected sample distribution, GFT was also compared to six common classification methods. The cascading GFT structure controlled an effectively infinite solution space that classified participants as recovered or not recovered significantly better than chance. It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods. Recovery sensitivity and specificity were 59% and 65% in the GFT validation set, respectively. These results provide initial evidence for the effectiveness of a GFT system to make clinical predictions of trauma symptom recovery using objective brain measures. Although clinical and research applications will require additional optimization of the system, these results highlight the future promise of AI in acute care.",2020,"It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods.",['Forty-three adolescents age 11 to 16 years with either mild traumatic brain injury or traumatic orthopedic injury were enrolled upon presentation to the emergency department'],[],['Recovery sensitivity and specificity'],"[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",[],"[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",43.0,0.0472421,"It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Fleck', 'Affiliation': 'University of Cincinnati, 2514, Cincinnati, Ohio, United States; david.fleck@uc.edu.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ernest', 'Affiliation': 'Cincinnati, Ohio, United States; nick.ernest@psibernetix.com.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Asch', 'Affiliation': 'University of Cincinnati, 2514, Cincinnati, Ohio, United States; aschrh@mail.uc.edu.'}, {'ForeName': 'Caleb M', 'Initials': 'CM', 'LastName': 'Adler', 'Affiliation': 'University of Cincinnati, 2514, Cincinnati, Ohio, United States; cal.adler@uc.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'University of Cincinnati, 2514, Cincinnati, Ohio, United States; kelly.cohen@uc.edu.'}, {'ForeName': 'Welhong', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 2518, Cincinnati, Ohio, United States; yuanwn@ucmail.uc.edu.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kunkel', 'Affiliation': 'Cincinnati, United States; brandon.kunkel@psibernetix.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krikorian', 'Affiliation': 'University of Cincinnati, 2514, Cincinnati, Ohio, United States; robert.krikorian@uc.edu.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States; shari.wade@cchmc.org.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 2518, Cincinnati, Ohio, United States; babcokln@ucmail.uc.edu.""}]",Journal of neurotrauma,['10.1089/neu.2020.7018']
1992,33119332,Supportive supervisor training improves family relationships among employee and spouse dyads.,"Employee family relationships have been increasingly tied to job outcomes and are known to be a strong predictor of employee health and well-being. As such, taking steps toward uncovering actionable tools organizations can implement to foster improvements in family relationship quality is important and should not be overlooked in occupational health psychology interventions. Supportive supervisor training (SST) targets improving employees' ability to meet their nonwork needs; however, the focus and discussions of the implications tied to SST have largely excluded marital and parent-child relationships, spouses, and spousal outcomes. Further, mounting evidence suggests contextual factors shape when SST is most meaningful; however, more research is needed to uncover individual-level factors that may facilitate training effects. This study used a cluster-randomized controlled trial design to evaluate a worksite-based SST with a sample of 250 employees (separated military veterans) and their matched spouses. Using an intent-to-treat approach and 2-level random effects models, results demonstrated that the SST promoted couples' dyadic marital relationship quality 9 months following baseline. Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST. Thus, an SST is beneficial for family relationships as reported by both employees and spouses, which goes beyond previously demonstrated employee health and well-being benefits. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST.",['250 employees (separated military veterans) and their matched spouses'],"['Supportive supervisor training', 'Supportive supervisor training (SST', 'worksite-based SST']","[""baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST"", ""couples' dyadic marital relationship quality""]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0024818', 'cui_str': 'Marital Relationship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0863655,"Additionally, when employees were under higher levels of baseline stress, couples' dyadic marital relationship quality and positive parenting both improved following the SST.","[{'ForeName': 'Jacquelyn M', 'Initials': 'JM', 'LastName': 'Brady', 'Affiliation': 'Department of Psychology, San José State University.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Hammer', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Mohr', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Todd E', 'Initials': 'TE', 'LastName': 'Bodner', 'Affiliation': 'Department of Psychology, Portland State University.'}]",Journal of occupational health psychology,['10.1037/ocp0000264']
1993,33119363,Promoting collaborative psychiatric care decision-making in community mental health centers: Insights from a patient-centered comparative effectiveness trial.,"OBJECTIVE


Mental health service-users face important medication decisions; yet not all are active participants in the decision-making process. Little is known about which technology-supported interventions might effectively promote collaborative decision-making in psychiatric care. We compared the effectiveness of two technology-supported collaborative care decision-making approaches.
METHOD


We used a cluster-randomized design with a mixed-methods approach. Participants were Medicaid-enrolled adults receiving psychiatric care in participating community mental health centers. Measurement-based care used computerized systematic symptom and medication screenings to inform provider decision-making. Person-centered care supported participants in completing computerized Health Reports and preparing to work with providers on collaborative decision-making about psychiatric care. Primary study outcomes included the patient experience of medication management and shared decision-making during psychiatric care. Analyses examined the impact of both approaches and explored moderating variables. We used qualitative methods to understand participation and implementation experiences.
RESULTS


Across 14 sites 2,363 participants enrolled (1,162 in measurement-based care, 1,201 in person-centered care). We observed statistically significant improvements in patient experience of medication management scores for both study arms; however, the clinical significance of this change was minor. We found no significant changes for shared decision-making. Qualitative interviews revealed a range of factors associated usefulness of intervention assessment, provider-service-user communication, and site-level logistics.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


We observed modest positive findings related to our patient-centered outcomes. We identified important implementation facilitators and barriers that can inform the implementation of future comparative effectiveness patient-centered research. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,We found no significant changes for shared decision-making.,"['Participants were Medicaid-enrolled adults receiving psychiatric care in participating community mental health centers', 'community mental health centers', 'Across 14 sites 2,363 participants enrolled (1,162 in measurement-based care, 1,201 in person-centered care']",[],"['patient experience of medication management and shared decision-making during psychiatric care', 'patient experience of medication management scores']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2363.0,0.0605796,We found no significant changes for shared decision-making.,"[{'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'MacDonald-Wilson', 'Affiliation': 'University of Pittsburgh Medical Center.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Center for High-Value Health Care.'}, {'ForeName': 'Cara E', 'Initials': 'CE', 'LastName': 'Nikolajski', 'Affiliation': 'Center for High-Value Health Care.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'McHugo', 'Affiliation': 'Geisel School of Medicine.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deegan', 'Affiliation': 'Pat Deegan and Associates, LLC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carpenter-Song', 'Affiliation': 'Geisel School of Medicine.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Kogan', 'Affiliation': 'Center for High-Value Health Care.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000455']
1994,33119423,Lack of residual morning effects of lemborexant treatment for insomnia: summary of findings across 9 clinical trials.,"OBJECTIVES


Residual next-day effects of sleep-promoting drugs are common and an important safety issue. Lemborexant is a dual orexin receptor antagonist approved in the United States and Japan for treatment of insomnia in adults. We evaluated the potential of lemborexant for residual morning and next-day effects, including somnolence, based on lemborexant clinical study findings.
METHODS


This paper reports findings from 9 lemborexant clinical studies that incorporated next-day assessments of residual drug effects, based on published findings and data on file. Results are reported for healthy subjects or subjects with insomnia disorder treated with lemborexant 5 mg/day or 10 mg/day, placebo, or active comparator before bedtime. Outcomes assessed included next-morning postural stability (body sway measured by ataxiameter), cognitive performance (Cognitive Performance Assessment Battery), impact on driving (standard deviation of lateral position during highway driving test), subjective sleepiness (sleep diary entries), and adverse events of somnolence.
RESULTS


Change from baseline in postural stability the morning after lemborexant administration did not differ from placebo. Among 4 Cognitive Performance Assessment Battery measures, only power of attention declined significantly more with lemborexant treatment compared with placebo in 1 of 2 studies, whereas zolpidem differed from placebo on multiple measures. On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ. In large phase 3 trials, next-morning sleep diary ratings showed significantly greater alertness with lemborexant compared with placebo after up to 6 months of treatment. As expected, somnolence was the most common adverse event reported with lemborexant treatment. Somnolence was typically mild to moderate in severity and rarely caused discontinuation of study drug.
CONCLUSION


Across 9 clinical studies, lemborexant did not substantially impair next-day functioning among healthy subjects and subjects with insomnia.",2020,"On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ.","['insomnia', 'healthy subjects or subjects with insomnia disorder treated with', 'healthy subjects and subjects with insomnia']","['Lemborexant', 'placebo', 'lemborexant']","['next-morning postural stability (body sway measured by ataxiameter), cognitive performance (Cognitive Performance Assessment Battery), impact on driving (standard deviation of lateral position during highway driving test), subjective sleepiness (sleep diary entries), and adverse events of somnolence', 'Somnolence', 'power of attention', 'driving performance', 'postural stability']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0567410', 'cui_str': 'Highway environment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0664147,"On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation , New York, New York, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Neurobiology Business Group, Eisai Ltd ., Hatfield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Neurobiology Business Group, Eisai Ltd ., Hatfield, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Jocelyn Y', 'Initials': 'JY', 'LastName': 'Cheng', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1823724']
1995,33119435,The mnemic neglect effect and information about dementia: age differences in recall.,"Dementia represents a more immediate threat for older than for younger adults. Consequently, different strategies may be used to defend the self against the threat of dementia. We hypothesised that older (compared to younger) adults are more likely to manifest mnemic neglect (in which information that is threatening to the self is selectively forgotten) to reduce distress for dementia-related information.Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity. Participants were randomised to recall statements that referred either to themselves or another person. High-negativity, self-referent statements had the most substantial threat potential. The recall of older (but not younger) participants for high-negativity (vs. low-negativity) dementia-related statements was impaired when these statements referred to the self rather than to another person. These results indicate that older adults evince mnemic neglect in response to self-threatening information about dementia.",2020,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"['older (compared to younger) adults', 'Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity']",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],[],,0.0449115,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cheston', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodd', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Christopher', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wildschut', 'Affiliation': 'School of Psychology, University of Southampton , Southampton, UK.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Sedikides', 'Affiliation': 'School of Psychology, University of Southampton , Southampton, UK.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1842850']
1996,33119467,Influence of prostaglandins and endothelial-derived hyperpolarizing factors on brachial and popliteal endothelial-dependent function in young adults.,"Heterogeneous flow-mediated dilation (FMD) and low-flow-mediated constriction (L-FMC) responses have been reported between upper- and lower-limb arteries. Radial artery L-FMC, but not FMD, responses are blunted when endothelial-derived hyperpolarizing factors (EDHF) or prostaglandin production are inhibited in young adults. However, it is unknown if these mechanisms similarly impact endothelial-dependent responses in the brachial (BA) and popliteal (POP) arteries. We tested the hypotheses that BA-L-FMC and POP-L-FMC would be attenuated following independent EDHF and prostaglandin inhibition. Eighteen participants (23 ± 3years; 6♀) completed 3 randomized and double-blinded ultrasound assessments following ingestion of an opaque capsule containing maltodextrin (Control), 150mg Fluconazole (EDHF inhibition) or 500mg Aspirin (prostaglandin inhibition). POP resting diameter was reduced following Fluconazole administration (6.13±0.63 mm versus 6.19±0.65 mm in Control, P=0.03). Compared to Control, Fluconazole also blunted the relative L-FMC responses in both the BA (-2.1 ± 0.8% versus -0.8 ± 1.0%, P=0.001) and POP (-1.7±1.1% versus -0.8±0.9%, P=0.009). In contrast, Aspirin did not impact either the BA (-1.9±0.7%) or POP-L-FMC (-1.3±0.6%) responses (both, P>0.35). The FMD response was unchanged following Fluconazole or Aspirin administration in either artery (both, P>0.36). Our findings demonstrate that EDHF mediates L-FMC responses in both the brachial and popliteal arteries. Complementary to the nitric oxide-mediated FMD response, L-FMC appears to provide information regarding the EDHF pathway. Future research should uncover if these mechanisms impact older adults and/or patient populations characterized by vascular endothelial dysfunction associated with low aerobic fitness and habitual physical activity levels.",2020,"POP resting diameter was reduced following Fluconazole administration (6.13±0.63 mm versus 6.19±0.65 mm in Control, P=0.03).","['young adults', 'Eighteen participants (23 ± 3years; 6♀']","['prostaglandins and endothelial-derived hyperpolarizing factors', 'Fluconazole', 'Aspirin', 'opaque capsule containing maltodextrin (Control), 150mg Fluconazole (EDHF inhibition) or 500mg Aspirin (prostaglandin inhibition', 'Fluconazole or Aspirin']","['FMD response', 'POP ', 'Heterogeneous flow-mediated dilation (FMD) and low-flow-mediated constriction (L-FMC) responses', 'EDHF mediates L-FMC responses', 'POP resting diameter', 'relative L-FMC responses']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0082428', 'cui_str': 'endothelium-dependent hyperpolarization factor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0082428', 'cui_str': 'endothelium-dependent hyperpolarization factor'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",18.0,0.1383,"POP resting diameter was reduced following Fluconazole administration (6.13±0.63 mm versus 6.19±0.65 mm in Control, P=0.03).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Petterson', 'Affiliation': 'Division of Kinesiology, School of Health and Human Performance, Faculty of Health, Dalhousie University, Canada.'}, {'ForeName': 'Myles William', 'Initials': 'MW', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Kinesiology, School of Health and Human Performance, Faculty of Health, Dalhousie University, Canada.'}, {'ForeName': 'Jarrett A', 'Initials': 'JA', 'LastName': 'Johns', 'Affiliation': 'Division of Kinesiology, School of Health and Human Performance, Faculty of Health, Dalhousie University, Canada.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Chiasson', 'Affiliation': 'Division of Kinesiology, School of Health and Human Performance, Faculty of Health, Dalhousie University, Canada.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Kimmerly', 'Affiliation': 'Division of Kinesiology, School of Health and Human Performance, Faculty of Health, Dalhousie University, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00698.2020']
1997,33119790,Regional vitamin C in Bier block reduces the incidence of CRPS-1 following distal radius fracture surgery.,"BACKGROUND


Systemic vitamin C supplementation after wrist fracture has been suggested to reduce the incidence of complex regional pain syndrome (CRPS). This study aimed to evaluate the effect of regional vitamin C in Bier block in the early phase of fracture on CRPS occurrence following surgery for distal radius fractures.
METHODS


Seventy-four patients with isolated extra-articular distal radius fracture with the plan of fixation under Bier block were enrolled. Patients were assigned randomly into two groups: receiving either 500 mg vitamin C or sterile water as a Bier block adjuvant. Both groups received 500 mg of oral vitamin C for six weeks. The patients were evaluated for CRPS signs and symptoms at 2, 4, 6, and 12 weeks post-surgery.
RESULTS


The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04). Logistic regression analysis showed that the only significant contribution in predicting the incidence of CRPS came from the intervention variable (OR 0.26, CI95% 0.08-0.85; P = 0.027).
CONCLUSIONS


The findings suggest that adding vitamin C 500 mg to the local anesthetic in Bier block significantly reduces the incidence of CRPS following distal radius fractures.",2020,"The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04).","['Seventy-four patients with isolated extra-articular distal radius fracture with the plan of fixation under Bier block were enrolled', 'distal radius fracture surgery']","['Regional vitamin C', '500\xa0mg of oral vitamin C', '500\xa0mg vitamin C or sterile water as a Bier block adjuvant', 'regional vitamin C', 'vitamin C']","['overall incidence of CRPS', 'incidence of CRPS']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]",74.0,0.0662965,"The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04).","[{'ForeName': 'Mahzad', 'Initials': 'M', 'LastName': 'Alimian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sobhani Eraghi', 'Affiliation': 'Department of Orthopaedics Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Alireza', 'Initials': 'SA', 'LastName': 'Chavoshizadeh', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran. Masood.mohseni@gmail.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Mousavi', 'Affiliation': 'Department of Sports Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Movassaghi', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02821-0']
1998,33119861,"Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.","BACKGROUND


Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48.
METHODS


Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity.
RESULTS


The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (- 2.16) and ref-ADL (- 2.18) with a mean difference (95% CI) of 0.02 (- 0.24 to 0.27), which was within the pre-specified equivalence margin of ± 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (- 3.09 vs - 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing.
CONCLUSIONS


In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).",2020,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","['patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including', 'Patients with Moderate-to-Severe Active Rheumatoid Arthritis', 'Eligible patients (N\u2009=\u2009353']","['Biosimilar SDZ-ADL', 'methotrexate (MTX', 'Sandoz adalimumab SDZ-ADL (GP-2017', 'subcutaneous (sc) SDZ-ADL 40\xa0mg (n\u2009=\u2009177) or ref-ADL', 'SDZ-ADL']","['proportion of patients in EULAR remission', 'efficacy, safety and immunogenicity', 'change in DAS28-CRP', 'proportion of patients with good/moderate EULAR response', 'efficacy, safety and immunogenicity comparability data', 'Antidrug antibodies', 'incidence of adverse events (AEs) and injection-site reactions', 'mean DAS28-CRP change', 'Efficacy', 'proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity', 'DAS28-CRP score changes', 'Boolean remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",353.0,0.0911073,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wiland', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland. pwiland1@gmail.com.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Jeka', 'Affiliation': 'Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilová', 'Affiliation': 'MEDICAL PLUS s.r.o., University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Uherske Hradiste, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brandt-Jürgens', 'Affiliation': 'Rheumatology Private Practice, Berlin, Germany.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Miranda Limón', 'Affiliation': 'RM Pharma Specialists, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cantalejo Moreira', 'Affiliation': 'Unidad de Reumatología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Raul Veiga', 'Initials': 'RV', 'LastName': 'Cabello', 'Affiliation': 'Hospital Central de la Defensa, Glorieta Ejército, 1, 28047, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jauch-Lembach', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Halimuniyazi', 'Initials': 'H', 'LastName': 'Haliduola', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Brueckmann', 'Affiliation': 'Global Medical Affairs, Biopharmaceutical, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Gaylis', 'Affiliation': 'Arthritis and Rheumatic Disease Specialties, Aventura, FL, USA.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00447-6']
1999,33119884,Is survival really better after repeated lung metastasectomy?,"Several groups have observed that average survival time after a second lung metastasectomy is longer than after a first metastasectomy. The randomised controlled trial Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) found no survival benefit from lung metastasectomy. In fact, median survival was longer, and four-year overall survival was higher, in the control group than in those randomly assigned to metastasectomy, although not significantly so. The illusion of benefit is because survival without metastasectomy has been assumed to be near zero, as stated in Society of Thoracic Surgeons' Expert Consensus Document on Pulmonary Metastasectomy 2019. It has been repeatedly found that survival is influenced by the selection of patients who have characteristics associated with better prognosis. The passage of time while monitoring and assessing patients, and observing their rate of progression, provides for immortal time bias. Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.",2020,Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.,['Colorectal Cancer'],[],"['survival benefit', 'average survival time', 'overall survival', 'median survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.103264,Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK. tom.treasure@gmail.com.'}]",Clinical & experimental metastasis,['10.1007/s10585-020-10061-z']
2000,33119892,Effects of protein and calorie restriction on the metabolism and toxicity profile of irinotecan in cancer patients.,"Preclinical data suggests that protein and calorie restriction (PCR) might improve treatment tolerability without impairing antitumor effect. Therefore, we have studied the influence of PCR on irinotecan pharmacokinetics and toxicity. In this cross-over trial, patients with liver metastases of solid tumors were included and randomized to treatment with irinotecan preceded by 5 days of PCR (~30% caloric and ~70% protein restriction) during the 1st cycle and a 2nd cycle preceded by a normal diet (ND) or vice versa. Pharmacokinetic blood sampling and biopsies of both healthy liver (HL) and liver metastasis (LM) were performed. Primary endpoint was the relative difference in geometric means for the active metabolite SN-38 concentration in HL analyzed by a linear mixed model. No significant differences were seen in irinotecan (+16.8%, P=0.22) and SN-38 (+9.8%, P=0.48) concentrations between PCR and ND in HL, as well as in LM (irinotecan: -38.8%, P=0.05 and SN-38: -13.8%, P=0.50). PCR increased irinotecan plasma AUC 0-24h  with 7.1% (P=0.04) compared to ND, while the SN-38 plasma AUC 0-24h  increased with 50.3% (P<0.001). Grade ≥3 toxicity was not increased during PCR vs ND (P=0.69). No difference was seen in neutropenia grade ≥3 (47% vs 32% P=0.38), diarrhea grade ≥3 (5% vs 21% P=0.25) and febrile neutropenia (5% vs 16% P=0.50) during PCR vs ND. In conclusion, plasma SN-38 exposure increased dramatically after PCR, while toxicity did not change. PCR did not alter the irinotecan and SN-38 exposure in HL and LM. PCR might therefore potentially improve the therapeutic window in patients treated with irinotecan.",2020,"No significant differences were seen in irinotecan (+16.8%, P=0.22) and SN-38 (+9.8%, P=0.48) concentrations between PCR and ND in HL, as well as in LM (irinotecan: -38.8%, P=0.05 and SN-38: -13.8%, P=0.50).","['cancer patients', 'patients with liver metastases of solid tumors']","['protein and calorie restriction (PCR', 'protein and calorie restriction', 'irinotecan']","['irinotecan pharmacokinetics and toxicity', 'relative difference in geometric means for the active metabolite SN-38 concentration', 'febrile neutropenia', 'SN-38', 'PCR', 'toxicity', 'Grade ≥3 toxicity', 'metabolism and toxicity profile', 'PCR increased irinotecan plasma AUC', 'diarrhea grade ≥3', 'neutropenia grade ≥3', 'SN-38 plasma AUC 0-24h', 'plasma SN-38 exposure', 'Pharmacokinetic blood sampling and biopsies of both healthy liver (HL) and liver metastasis (LM']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0142710', 'cui_str': 'SN-38'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]",,0.0449413,"No significant differences were seen in irinotecan (+16.8%, P=0.22) and SN-38 (+9.8%, P=0.48) concentrations between PCR and ND in HL, as well as in LM (irinotecan: -38.8%, P=0.05 and SN-38: -13.8%, P=0.50).","[{'ForeName': 'Femke M', 'Initials': 'FM', 'LastName': 'de Man', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ruben A G', 'Initials': 'RAG', 'LastName': 'van Eerden', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Gerdien M', 'Initials': 'GM', 'LastName': 'van Doorn', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Olieman', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Joris N', 'Initials': 'JN', 'LastName': 'Veraart', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk K', 'Initials': 'HK', 'LastName': 'van Halteren', 'Affiliation': 'Department of Internal Medicine, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Yorick', 'Initials': 'Y', 'LastName': 'Sandberg', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Moelker', 'Affiliation': 'Department of Radiology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn P', 'Initials': 'MP', 'LastName': 'Lolkema', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn E T', 'Initials': 'MET', 'LastName': 'Dollé', 'Affiliation': 'Centre for Health protection research, National Institute for Public Health and Environment (RIVM), Bilthoven, The Netherlands.'}, {'ForeName': 'Ron W F', 'Initials': 'RWF', 'LastName': 'de Bruin', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2094']
2001,33119908,The effects of health coaching on frequent attenders' adherence to health regimens and lifestyle factors: a quasi-experimental study.,"AIMS


The aim of this study was to evaluate the effects of nurse-led health coaching on adherence to health regimens and lifestyle factors among frequent attenders in primary health care.
METHODS


One hundred and ten patients were enrolled in the quasi-experimental study. The experimental group (n = 52) received nurse-led health coaching and the control group (n = 58) received conventional care at primary healthcare centres between 2015 and 2016. Data were collected before the intervention and 12 months afterwards using a questionnaire on adherence to health regimens and lifestyle factors. The intervention consisted of individual health coaching provided by a nurse, health-coaching sessions, and a written action plan.
RESULTS


Frequent attenders exhibited good adherence to health regimens. After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups. However, nurse-led health coaching improved adherence to health regimens and physical activity in the experimental group.
CONCLUSION


Nurse-led health coaching appears to promote participation and adherence to health regimens among frequent attenders at primary healthcare facilities. Before starting the health-coaching programme, it is recommended to carefully specify the content of health coaching and test the nurses' health-coaching competence.",2020,"After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups.","['One hundred and ten patients were enrolled in the quasi-experimental study', 'frequent attenders in primary health care']","['Nurse-led health coaching', 'health coaching', 'nurse-led health coaching and the control group (n\xa0=\xa058) received conventional care', 'nurse-led health coaching', 'individual health coaching provided by a nurse, health-coaching sessions, and a written action plan']",['adherence to health regimens and/or lifestyle factors'],"[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",110.0,0.0142087,"After the intervention, there were no significant differences in adherence to health regimens and/or lifestyle factors between the experimental and control groups.","[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Kivelä', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Elo', 'Affiliation': 'Lapland University of Applied Sciences, Kemi, Finland.'}, {'ForeName': 'Helvi', 'Initials': 'H', 'LastName': 'Kyngäs', 'Affiliation': 'Medical Research Center Oulu, University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, Oulu University Hospital, University of Oulu, Oulu, Finland.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12920']
2002,33113806,Evaluation of Psychophysical Factors in Individuals with Frailty Syndrome Following a 3-Month Controlled Physical Activity Program.,"BACKGROUND


The aim of the study was to compare the emotional state and strength-velocity parameters of patients with frailty and pre-frailty syndrome undertaking a 12-week training programme.
METHODS


The study was completed by 36 individuals, including 17 with frailty syndrome (FS) and 19 with pre-frailty syndrome (PFS). The age of the subjects ranged from 63 to 89 years, with a mean 69.2 years (±5.0). The Beck Depression Inventory (BDI), Spielberg's State-Trait Anxiety Inventory (STAI), and Satisfaction with Life Scale (SWLS) were used. The strength of knee muscles was evaluated. The above tests were conducted at two time points: before the training sessions (T1); and after 12 weeks of regular training sessions (T2).
RESULTS


After completion of the training programme, statistically significant differences in BDI were observed between the PFS and FS groups (especially in somatic symptoms). Following the training, BDI values in the PFS group were significantly lower (fewer depressive symptoms) than in the FS group. The parameter values describing strength capacities of the lower limbs, both at T1 and T2, proved to be higher in the PFS group.
CONCLUSIONS


In individuals with pre-frailty and frailty syndrome, the 3-month physical training programme improved the strength parameters of lower limb muscles. An improvement in mood and reduction in depressive symptoms were only observed in the group of subjects with pre-frailty syndrome. Rehabilitation programmes for people with frailty syndrome should include psychotherapeutic activities in addition to physical training in order to improve the psychophysical condition of patients.",2020,"Following the training, BDI values in the PFS group were significantly lower (fewer depressive symptoms) than in the FS group.","['individuals with pre-frailty and frailty syndrome', 'The age of the subjects ranged from 63 to 89 years, with a mean 69.2 years (±5.0', 'Individuals with Frailty Syndrome Following a 3-Month Controlled Physical Activity Program', '36 individuals, including 17 with frailty syndrome (FS) and 19 with pre-frailty syndrome (PFS', 'people with frailty syndrome', 'patients with frailty and pre-frailty syndrome']",['physical training programme'],"['strength of knee muscles', 'BDI values', 'emotional state and strength-velocity parameters', 'BDI', 'strength parameters of lower limb muscles', ""Beck Depression Inventory (BDI), Spielberg's State-Trait Anxiety Inventory (STAI), and Satisfaction with Life Scale (SWLS"", 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4505081', 'cui_str': 'Frailty Syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0171779,"Following the training, BDI values in the PFS group were significantly lower (fewer depressive symptoms) than in the FS group.","[{'ForeName': 'Wioletta', 'Initials': 'W', 'LastName': 'Dziubek', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Pawlaczyk', 'Affiliation': 'Lower Silesia Oncology Center, 53-413 Wroclaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Stefańska', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Waligóra', 'Affiliation': 'Department of Family Medicine, Wroclaw Medical University, 51-141 Wroclaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bujnowska-Fedak', 'Affiliation': 'Department of Family Medicine, Wroclaw Medical University, 51-141 Wroclaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kowalska', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17217804']
2003,33114186,Effects of Post-Exercise Whey Protein Consumption on Recovery Indices in Adolescent Swimmers.,"Purpose : This study examined the effect of whey protein consumption following high-intensity interval swimming (HIIS) on muscle damage, inflammatory cytokines and performance in adolescent swimmers.  Methods : Fifty-four swimmers (11-17 years-old) were stratified by age, sex and body mass to a whey protein (PRO), isoenergetic carbohydrate (CHO) or a water/placebo (H 2 O) group. Following baseline blood samples (06:00 h) and a standardised breakfast, participants performed a maximal 200 m swim, followed by HIIS. A total of two post-exercise boluses were consumed following HIIS and ~5 h post-baseline. Blood and 200 m performance measurements were repeated at 5 h, 8 h and 24 h from baseline. Muscle soreness was assessed at 24 h. Creatine kinase (CK), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor-alpha (TNF-α) were measured in plasma.  Results : No difference in 200 m swim performance was observed between groups. CK activity was elevated at 5 h compared to baseline and 24 h and at 8 h compared to all other timepoints, with no differences between groups. Muscle soreness was lower in PRO compared to H 2 O ( p  = 0.04). Anti-inflammatory IL-10 increased at 8 h in PRO, while it decreased in CHO and H 2 O.  Conclusions : Post-exercise consumption of whey protein appears to have no additional benefit on recovery indices following HIIS compared to isoenergetic amounts of carbohydrate in adolescent swimmers. However, it may assist with the acute-inflammatory response.",2020,"Muscle soreness was assessed at 24 h. Creatine kinase (CK), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor-alpha (TNF-α) were measured in plasma.  ","['Methods : Fifty-four swimmers (11-17 years-old', 'Adolescent Swimmers', 'adolescent swimmers']","['whey protein consumption following high-intensity interval swimming (HIIS', 'Post-Exercise Whey Protein Consumption', 'whey protein (PRO), isoenergetic carbohydrate (CHO) or a water/placebo']","['Creatine kinase (CK), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor-alpha (TNF-α', 'muscle damage, inflammatory cytokines and performance', 'Muscle soreness', 'Anti-inflammatory IL-10', '200 m swim performance', 'Recovery Indices', 'CK activity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210036,"Muscle soreness was assessed at 24 h. Creatine kinase (CK), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor-alpha (TNF-α) were measured in plasma.  ","[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'McKinlay', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Theocharidis', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Adebero', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kurgan', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Val A', 'Initials': 'VA', 'LastName': 'Fajardo', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Roy', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'M Logan-Sprenger', 'Affiliation': 'Canadian Sport Institute Ontario, 857 Morningside Avenue, Toronto, ON M1C 0C7, Canada.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17217761']
2004,33114210,"Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy.","AIM


To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN).
PATIENTS-METHODS


In this prospective, double-blind, placebo-controlled study, 85 patients with Diabetes Mellitus Type 2 (DMT2) were randomly assigned, either to receive the combination of four elements (active group,  n  = 43), or placebo ( n  = 42) for 12 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured the vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Pain (PS) and quality of life (QL) questionnaires were administered.
RESULTS


At follow-up, BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels had significantly improved inactive group ( p  <0.001,  p  <0.001,  p  <0.001,  p  <0.001,  p  = 0.027,  p  = 0.031, and  p  <0.001 respectively), whereas the inplacebo group MCR (mean circular resultant) and PAIN deteriorated ( p  <0.001,  p  <0.001). The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups ( p  <0.001,  p  <0.001,  p  = 0.031,  p  <0.001, and  p  <0.001 respectively).
CONCLUSIONS


The combination of the four elements in one tablet for 12 months in patients with DMT2 improved all indices of peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE.",2020,"The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups ( p  <0.001,  p  <0.001,  p  = 0.031,  p  <0.001, and  p  <0.001 respectively).
","['Diabetic Neuropathy (DN', 'Patients with Diabetic Neuropathy', '85 patients with Diabetes Mellitus Type 2 (DMT2']","['placebo', 'Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12', 'Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine']","['DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP', 'BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels', 'Pain (PS) and quality of life (QL) questionnaires', 'Nerve function', 'peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE', 'vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs', 'PAIN deteriorated', 'MNSIQ, QL, SNCV, BIO, and PAIN', 'Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE']","[{'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}]","[{'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0038879', 'cui_str': 'Structure of sural nerve'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1842357', 'cui_str': 'Autosomal dominant slowed nerve conduction velocity'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",85.0,0.246821,"The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups ( p  <0.001,  p  <0.001,  p  = 0.031,  p  <0.001, and  p  <0.001 respectively).
","[{'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Didangelos', 'Affiliation': 'Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Karlafti', 'Affiliation': 'Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Kotzakioulafi', 'Affiliation': 'Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Zisis', 'Initials': 'Z', 'LastName': 'Kontoninas', 'Affiliation': 'Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Margaritidis', 'Affiliation': 'Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Parthena', 'Initials': 'P', 'LastName': 'Giannoulaki', 'Affiliation': 'Department of Nutrition and Dietetics, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University of Tübingen, 72076 Tübingen, Germany.'}]",Nutrients,['10.3390/nu12113254']
2005,33114364,"Different Amounts of Water Supplementation Improved Cognitive Performance and Mood among Young Adults after 12 h Water Restriction in Baoding, China: A Randomized Controlled Trial (RCT).","Water is indispensable to keeping the functions of the human body working properly, including that of the brain. The purpose of this research was to explore the impacts of water supplementation on cognitive performance and mood, and to determine the optimum amount of water to alleviate detriments of dehydration after 12 h water restriction. A randomized controlled trial was implemented among 64 young adults from Baoding, China. Fasting overnight for 12 h, and at 8:00 a.m. on day 2, osmolality of first morning urine and blood, cognitive performance, and mood were assessed as the dehydration test. Then, participants were randomly separated into four groups: water supplementation groups (WS groups 1, 2, and 3 with 500, 200, and 100 mL purified water, respectively) and no water supplementation group (NW group). Participants in WS groups were instructed to drink the water within 10 min, while those in NW group drank no water. After 90 min, the same measurements were taken as the rehydration test. There was significant interaction between TIME and VOLUME in thirst when comparing dehydration with rehydration tests ( F  = 6.172,  p  = 0.001). Significant thirst reductions were found in WS group 1 and WS group 2 ( p  = 0.003;  p  = 0.041), and a significant increase was found in the NW group ( p  = 0.039). In the rehydration test, significant interactions between TIME and VOLUME were found in scores of anger, fatigue, and TMD (total mood disturbance) ( F  = 3.815,  p  = 0.014;  F  = 10.429,  p  < 0.001;  F  = 5.246,  p  < 0.001), compared to the dehydration test. Scores of anger were only decreased in WS group 2 ( p  = 0.025), and scores of fatigue and TMD decreased in WS group 1 and WS group 2 (all  p  < 0.05). Significant interaction between TIME and VOLUME was only found for operation span test scores ( F  = 2.816,  p  = 0.047), with scores being only higher in WS group 1 in the rehydration test compared to the dehydration test ( p  = 0.003). Comparing WS group 1 and WS group 2, scores of thirst, fatigue, and TMD did not differ significantly ( p  > 0.05). Water supplementation improved working memory and attenuated anger, fatigue, and TMD. A small amount of water (200 mL) was sufficient to attenuate thirst, anger, fatigue, and TMD of young adults, but the larger volume (500 mL) appeared to be necessary to improve working memory. The amount of 500 mL was the optimum volume to improve the cognitive performance and mood among young adults.",2020,"Comparing WS group 1 and WS group 2, scores of thirst, fatigue, and TMD did not differ significantly ( p  > 0.05).","['64 young adults from Baoding, China', 'young adults', 'Young Adults after 12 h Water Restriction in Baoding, China']","['Water Supplementation', 'NW group drank no water', 'water supplementation']","['scores of thirst, fatigue, and TMD', 'working memory and attenuated anger, fatigue, and TMD', 'scores of fatigue and TMD', 'cognitive performance and mood', 'TIME and VOLUME', 'Cognitive Performance and Mood', 'operation span test scores', 'scores of anger, fatigue, and TMD (total mood disturbance', 'osmolality of first morning urine and blood, cognitive performance, and mood', 'Scores of anger']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",64.0,0.0410062,"Comparing WS group 1 and WS group 2, scores of thirst, fatigue, and TMD did not differ significantly ( p  > 0.05).","[{'ForeName': 'Jianfen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing 100053, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17217792']
2006,33114652,"Safety, Efficacy and Pharcacokinetics of Targeted Therapy with The Liposomal RNA Interference Therapeutic Atu027 Combined with Gemcitabine in Patients with Pancreatic Adenocarcinoma. A Randomized Phase Ib/IIa Study.","BACKGROUND


Atu027 is a liposomally formulated short interfering RNA with anti-metastatic activity, which silences the expression of protein kinase N3 (PKN3) in the vascular endothelium. This trial was designed to assess the safety, pharmacokinetics and efficacy of Atu027 in combination with gemcitabine in advanced pancreatic carcinoma (APC).
METHODS


In total, 23 patients (pts) with inoperable APC were randomly assigned to gemcitabine combined with two different Atu027 schedules (0.235 mg/kg once weekly vs. 0.235 mg/kg twice weekly). ClinicalTrials.gov Identifier: NCT01808638.
RESULTS


The treatment was well-tolerated. There were Grade 3 adverse events (AEs) in 9/11 pts (arm 1) and 11/12 pts (arm 2), while Grade 4 AEs were reported for two pts in each arm. The AEs were mainly laboratory abnormalities without clinical significance. The median progression-free survival reached statistical significance in patients who had metastatic disease (1.6 vs. 2.9 months,  p  = 0.025). Disease control during treatment was achieved in 4/11 pts (arm 1) and in 7/12 pts (arm 2). Pts in arm 1 experienced stable global health status while pts in arm 2 reported improvement.
CONCLUSIONS


Combining Atu027 with gemcitabine is safe and well tolerated. In pts with metastatic APC, twice-weekly Atu027 is associated with significantly improved outcomes. Our clinical results support the significant involvement of the vascular endothelium in the spread of cancer, and thus the further investigation of its target role.",2020,"There were Grade 3 adverse events (AEs) in 9/11 pts (arm 1) and 11/12 pts (arm 2), while Grade 4 AEs were reported for two pts in each arm.","['23 patients (pts) with inoperable APC', 'Patients with Pancreatic Adenocarcinoma', 'advanced pancreatic carcinoma (APC']","['gemcitabine', 'Gemcitabine']","['Grade 3 adverse events', 'stable global health status', 'safe and well tolerated', 'Safety, Efficacy and Pharcacokinetics', 'tolerated', 'median progression-free survival', 'safety, pharmacokinetics and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",23.0,0.0723652,"There were Grade 3 adverse events (AEs) in 9/11 pts (arm 1) and 11/12 pts (arm 2), while Grade 4 AEs were reported for two pts in each arm.","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Schultheis', 'Affiliation': 'Department of Hematology and Oncology, Marien Hospital Herne, University of Bochum, 44627 Herne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Strumberg', 'Affiliation': 'Department of Hematology and Oncology, Marien Hospital Herne, University of Bochum, 44627 Herne, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Medicine II, University Hospital Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Department of Medicine, Hospital Kassel, 34125 Kassel, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Link', 'Affiliation': 'Department of Medicine V, Hospital Nuernberg Nord, 90419 Nuernberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Medicine I, Universitätsklinikum Ulm, 89081 Ulm, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Kaufmann', 'Affiliation': 'Silence Therapeutics GmbH, 13125 Berlin, Germany.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Feist', 'Affiliation': 'Department of Surgery, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gebhardt', 'Affiliation': 'Silence Therapeutics GmbH, 13125 Berlin, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Department of Biological Sciences, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical faculty, Humboldt-Universität zu Berlin, 10099 Berlin, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Medical faculty, Humboldt-Universität zu Berlin, 10099 Berlin, Germany.'}]",Cancers,['10.3390/cancers12113130']
2007,33114782,Using Machines or Free Weights for Resistance Training in Novice Males? A Randomized Parallel Trial.,"This study compared the effect of a resistance training (RT) program with machines, free weights, or a combination of both on changes in anthropometrics, strength, and functional ability in novice adult males. Thirty-six male novices in RT (18-45 years) followed a 10-week RT program. Participants were randomly assigned to one of three groups (N = 12 each): machines only; free weights only; or switching from machines to free weights (after 5 weeks). Muscle size (circumferences of upper arm, thigh and chest), strength (1 Repetition Maximum) on both machines and free weights, and functional ability (Functional Movement Screen TM  (Functional Movement Systems Inc., Chatham, VA, USA)) were assessed prior to the RT program, halfway at 5 weeks, and within one week after the final training bout. Repeated measures MANOVAs showed no significant time by RT group interactions for the different outcome measures. Regardless of RT group, significant improvements over time were observed for anthropometrics (F = 9.144,  p  < 0.001), strength (F = 6.918,  p  < 0.001), and functional ability (F = 25.578,  p  < 0.001). To conclude, similar gains in muscularity, strength, and functional ability can be expected for male novices in RT regardless of the equipment being used and without a fallback when changing from machines to free weights. Accordingly, any choice of RT equipment can be made, considering individual preferences.",2020,"Regardless of RT group, significant improvements over time were observed for anthropometrics (F = 9.144,  p  < 0.001), strength (F = 6.918,  p  < 0.001), and functional ability (F = 25.578,  p  < 0.001).","['novice adult males', 'Thirty-six male novices in RT (18-45 years) followed a 10-week RT program', 'Novice Males']","['machines only; free weights only; or switching from machines to free weights', 'resistance training (RT) program']","['functional ability', 'Muscle size (circumferences of upper arm, thigh and chest), strength (1 Repetition Maximum) on both machines and free weights, and functional ability (Functional Movement Screen TM  (Functional Movement Systems Inc., Chatham, VA, USA', 'muscularity, strength, and functional ability', 'strength']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]",36.0,0.0302974,"Regardless of RT group, significant improvements over time were observed for anthropometrics (F = 9.144,  p  < 0.001), strength (F = 6.918,  p  < 0.001), and functional ability (F = 25.578,  p  < 0.001).","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Aerenhouts', 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, 1050 Brussels, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': ""D'Hondt"", 'Affiliation': 'Department of Movement and Sport Sciences, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, 1050 Brussels, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph17217848']
2008,33114906,Spatio-spectral metrology at focus of ultrashort lasers: a phase-retrieval approach: erratum.,"This is an erratum on the manuscript entitled 'Spatio-spectral metrology at focus of ultrashort lasers: a phase-retrieval approach', by A. Borot and F. Quéré [Opt. Express26, 26444 (2018)].",2020,"[Opt. Express26, 26444 (2018)].",[],['ultrashort lasers'],[],[],"[{'cui': 'C0023089', 'cui_str': 'Laser device'}]",[],,0.0149495,"[Opt. Express26, 26444 (2018)].","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Borot', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Quéré', 'Affiliation': ''}]",Optics express,['10.1364/OE.410343']
2009,33115278,Ticagrelor or Prasugrel in Patients with ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.,"Background:  Data on the comparative efficacy and safety of ticagrelor versus prasugrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) are limited. We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head comparison in STEMI patients undergoing primary PCI.  Methods:  In this pre-specified subgroup analysis, we included 1653 patients with STEMI randomized to receive ticagrelor or prasugrel in the setting of the ISAR REACT-5 trial. The primary endpoint was the incidence of death, myocardial infarction or stroke at 1 year after randomization. The secondary endpoint was the incidence of bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding at 1 year after randomization.  Results:  The primary endpoint occurred in 83 patients (10.1%) in the ticagrelor group and in 64 patients (7.9%) in the prasugrel group (hazard ratio [HR]=1.31; 95% confidence interval [CI] 0.95-1.82; P=0.10). One-year incidence of all-cause death (4.9% vs. 4.7%; P=0.83), stroke (1.3% vs. 1.0%; P=0.46) and definite stent thrombosis (1.8% vs. 1.0%; P=0.15) did not differ significantly in patients assigned to ticagrelor or prasugrel. One-year incidence of myocardial infarction (5.3% vs. 2.8%; HR=1.95 [1.18-3.23], P=0.010) was higher with ticagrelor than with prasugrel. BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (HR=1.22 [0.80-1.87]; P=0.36).  Conclusions:  In patients with STEMI undergoing primary PCI, there was no significant difference in the primary endpoint between prasugrel and ticagrelor. Ticagrelor was associated with a significant increase in the risk for recurrent myocardial infarction.  Clinical Trial Registration:  URL: https://www.clinicaltrials.gov; Unique identifier NCT01944800.",2020,BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (HR=1.22 [0.80-1.87]; P=0.36).  ,"['1653 patients with STEMI randomized to receive', 'STEMI patients undergoing primary PCI', 'Patients with ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention', 'patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI']","['ticagrelor or prasugrel', 'Ticagrelor', 'ticagrelor versus prasugrel', 'ticagrelor', 'Ticagrelor or Prasugrel']","['myocardial infarction', 'BARC type 3 to 5 bleeding', 'definite stent thrombosis', 'efficacy and safety', 'cause death', 'risk for recurrent myocardial infarction', 'incidence of death, myocardial infarction or stroke', 'stroke', 'incidence of bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",1653.0,0.206631,BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (HR=1.22 [0.80-1.87]; P=0.36).  ,"[{'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Aytekin', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Franz Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Dept. of Cardiology, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Shqipdona', 'Initials': 'S', 'LastName': 'Lahu', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum Dachau, Cardiology & Pneumology, Dachau, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany; Klinik der Universität München, Ludwig - Maximilians - University, Cardiology, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany.'}, {'ForeName': 'Hendrik B', 'Initials': 'HB', 'LastName': 'Sager', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Wustrow', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fusaro', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany.'}, {'ForeName': 'Karl Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München, both in Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050244']
2010,33115285,A Randomized Controlled Ixekizumab Vs Secukinumab Trial to study the Impact on Sexual Activity in Adult Patients with Genital Psoriasis.,"INTRODUCTION


There is limited data on the effects of biologic therapies on genital psoriasis and sexual activity. Recently, Ixekizumab was reported to be effective.
AIM


To compare the efficacy of ixekizumab and secukinumab for treatment of genital psoriasis and sexual inadequacy in adult patients with moderate-to-severe psoriasis.
PATIENTS AND METHODS


We assessed adult patients with moderate-to-severe psoriasis having genital involvement. They were randomly assigned in a 1:1 ratio to receive either ixekizumab (80 mg/2 weeks after 160-mg initial dose) or secukinumab (300 mg subcutaneous injection at Weeks 0, 1, 2, 3 and 4 then every 4 weeks). The severity was assessed using Genital Psoriasis Symptoms Scale (GPSS), and impact on sexual health by evaluating the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ).
RESULTS


28 patients on ixekizumab, and 26 on secukinumab showed improvement in genital psoriasis symptoms, beginning week 2 (GPSS total and individual items), and from week 4 onwards, improvement in sexual activity was seen with both drugs.
CONCLUSION


Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors. Limitations included small number of patients and lack of follow up period.",2020,Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors.,"['Adult Patients with Genital Psoriasis', 'adult patients with moderate-to-severe psoriasis having genital involvement', '28 patients on', 'adult patients with moderate-to-severe psoriasis']","['Ixekizumab', 'secukinumab', 'ixekizumab', 'ixekizumab and secukinumab', 'Ixekizumab Vs Secukinumab']","['Genital Psoriasis Symptoms Scale (GPSS), and impact on sexual health by evaluating the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ', 'Sexual Activity', 'genital psoriasis and sexual activity', 'sexual activity', 'genital psoriasis symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0624372,Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors.,"[{'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Al-Mutairi', 'Affiliation': 'Professor of Dermatology, Department of Medicine, Faculty of Medicine, Kuwait University.'}, {'ForeName': 'Bayoumy Ibrahim', 'Initials': 'BI', 'LastName': 'Eassa', 'Affiliation': 'Department of Dermatology, Farwaniya Hospital.'}]",Expert opinion on biological therapy,['10.1080/14712598.2021.1843629']
2011,33115517,Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.,"BACKGROUND


Previous studies have demonstrated that no-option angiitis-induced critical limb ischemia (NO-AICLI) could be significantly improved by transplantation of peripheral blood-derived stem cells (PBDSCs). Additionally, a randomized controlled trial (RCT) recently conducted by us suggested that peripheral blood-derived purified CD34+ cells (PCCs) were not inferior to non-purified peripheral blood mononuclear cells (PBMNCs) at limb salvage in treatment of NO-AICLI. However, most of these clinical trials whether RCT or single-arm studies were characterized with a small sample size and absence of long-term outcomes.
METHODS


To analyze long-term clinical outcomes of PBDSCs transplantation for NO-AICLI, we reviewed clinical data of patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade. Meanwhile, we first compared the long-term safety and efficacy of intramuscular transplantation of PCCs versus PBMNCs in a sizable number of patients with NO-AICLI.
RESULTS


From May 2009 to December 2019, a total of 160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center. Baseline characteristics between two groups were similar. Up to June 2020, the mean follow-up period was 46.6 ± 35.3 months. No critical adverse events were observed in either group. There was one death during the follow-up period. A total of eight major amputations occurred. The cumulative major amputation-free survival (MAFS) rate at 5 years after PBDSCs transplantation was 94.4%, without difference between two groups (P = .855). Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation.
CONCLUSIONS


Autologous PBDSCs intramuscular transplantation could significantly decrease the major amputation rates and improve the QoL in patients with NO-AICLI. Long-term observation of a large sample of patients confirmed that the clinical benefits of PBDSCs transplantation were durable, without difference between the PCCs and PBMNCs groups.",2020,"Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation.
","['160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center', 'patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade', 'patients with NO-AICLI']","['intramuscular transplantation of PCCs versus PBMNCs', 'Autologous peripheral blood-derived stem cells transplantation', 'RCT']","['Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL', 'cumulative major amputation-free survival (MAFS) rate', 'adverse events', 'major amputation rates', 'peripheral blood-derived purified CD34+ cells (PCCs']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}]",160.0,0.0386445,"Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation.
","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaolang', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Tianyue', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bichen', 'Initials': 'B', 'LastName': 'Ren', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shiyang', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Daqiao', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. fu.weiguo@zs-hospital.sh.cn.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. dzh926@126.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01981-4']
2012,33115524,A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial.,"BACKGROUND


Transitioning care from hospital to home is associated with risks of adverse events and poor continuity of care. These transitions are even more challenging when new approaches to care, such as palliative care, are introduced before discharge. Family caregivers (FCGs) are expected to navigate these transitions while also managing care. In addition to extensive caregiving responsibilities, FCGs often have their own health needs that can inhibit their ability to provide care. Those living in rural areas have even fewer resources to meet their self-care and caregiving needs. The purpose of this study is to test the efficacy and cost-effectiveness of an intervention to improve FCGs' health and well-being. The intervention uses video visits to teach, guide, and counsel FCGs in rural areas during hospital-to-home transitions. The intervention is based on evidence of transitional and palliative care principles, which are individualized to improve continuity of care, provide caregiver support, enhance knowledge and skills, and attend to caregivers' health needs. It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost. We describe the rationale for targeting rural caregivers, the methods for the study and intervention, and the analysis plan to test the intervention's effect.
METHODS


The study uses a randomized controlled trial design, with FCGs assigned to the control condition or the caregiver intervention by computer-generated lists. The intervention period continues for 8 weeks after care recipients are discharged from the hospital. Data are collected at baseline, 2 weeks, 8 weeks, and 6 months. Time and monetary costs from a societal perspective are captured monthly.
DISCUSSION


This study addresses 2 independent yet interrelated health care foci-transitional care and palliative care-by testing an intervention to extend palliative care practice and improve transition management for caregivers of seriously ill patients in rural areas. The comprehensive cost assessment will quantify the commitment and financial burden of FCGs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03339271 . Registered on 13 November 2017. Protocol version: 11.",2020,"It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost.","['caregivers of seriously ill patients in rural areas', 'Family caregivers (FCGs', 'adult family caregivers in rural or medically underserved areas']",[],"['efficacy and cost-effectiveness', 'Time and monetary costs', 'quality of life, burden, coping skills, depression), and (3) cost']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.105699,"It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost.","[{'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Holland', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Vanderboom', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Mandrekar', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Bijan J', 'Initials': 'BJ', 'LastName': 'Borah', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Dose', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Ingram', 'Affiliation': 'Center for Palliative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Griffin', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA. griffin.joan@mayo.edu.'}]",Trials,['10.1186/s13063-020-04806-0']
2013,33115527,Early recognition and response to increases in surgical site infections using optimized statistical process control charts-the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design.,"BACKGROUND


Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance.
METHODS


The Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8-9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone.
DISCUSSION


The traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the ""signal"" is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03075813 , Registered March 9, 2017.",2020,"The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone.
","['29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4\xa0years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8-9 clusters', 'All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal']",[],"['traditional surveillance and feedback alone', 'rates of SSI', 'SSI rates', 'average SSI rates', 'surgical site infections']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",[],"[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",,0.204826,"The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone.
","[{'ForeName': 'Deverick J', 'Initials': 'DJ', 'LastName': 'Anderson', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, NC, USA. deverick.anderson@duke.edu.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Ilieş', 'Affiliation': 'Healthcare Systems Engineering Institute, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Foy', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, NC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nehls', 'Affiliation': 'Healthcare Systems Engineering Institute, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Benneyan', 'Affiliation': 'Healthcare Systems Engineering Institute, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Department of Biostatistics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Arthur W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, NC, USA.'}]",Trials,['10.1186/s13063-020-04802-4']
2014,33115543,Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.
HYPOTHESIS


Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU).
TRIAL DESIGN


This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization.
PARTICIPANTS


Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
EXCLUSION CRITERIA


Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic.
INTERVENTION AND COMPARATOR


Imatinib: All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo: The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care: In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs.
MAIN OUTCOMES


The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days.
RANDOMIZATION


Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2  ≤92% on ambient air or PaO 2 /FiO 2  <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy.
BLINDING (MASKING)


The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site's Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease.
TRIAL STATUS


Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the ""Study May Proceed"" Letter for this clinical trial under the Investigational New Drug (IND) number 149239.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.,"['Inclusion Criteria', 'patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4', 'Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial', 'hospitalized adults with COVID-19', 'hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death', 'patients having difficulty swallowing', 'participants who experience progression of COVID-19 disease after study enrollment', 'patients with COVID-19 compared with BCC plus', 'Hospitalized Adults with COVID-19', '4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2', 'hospitalized patients with COVID-19', 'Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1', 'patients with critical COVID-19 infection in Intensive Care Unit (ICU']","['Concomitant Medications/supportive care', 'hydroxychloroquine', 'supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy', 'imatinib or placebo', 'placebo plus BCC', 'ECMO, placebo', 'imatinib combined with the Best Conventional Care (BCC', 'Imatinib 400 mg capsules and placebo', 'Imatinib', 'Imatinib or Arm B) Placebo', 'Imatinib 400', 'placebo', 'imatinib', 'Direct bilirubin', 'Placebo', 'placebos', 'Co']","['8-category ordinal scale', 'Safety and Efficacy', 'efficacy and safety', 'safety and efficacy', 'proportion of patients with a two-point improvement', 'IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days', ' All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0421203', 'cui_str': 'Home oxygen supply'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1960093', 'cui_str': 'Nonrebreather oxygen mask'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1331284', 'cui_str': 'imatinib 400 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",1.0,0.286981,Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.,"[{'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Emadi', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA. aemadi@umm.edu.'}, {'ForeName': 'Joel V', 'Initials': 'JV', 'LastName': 'Chua', 'Affiliation': 'University of Maryland School of Medicine Department of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Talwani', 'Affiliation': 'University of Maryland School of Medicine Department of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Søren M', 'Initials': 'SM', 'LastName': 'Bentzen', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Baddley', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA.'}]",Trials,['10.1186/s13063-020-04819-9']
2015,33115545,Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.,"BACKGROUND


Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities.
METHODS


A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study.
DISCUSSION


The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.",2020,A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts.,"['twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia', 'Retrospectively registered on 29 August 2018']","['Internet-based Cognitive Behavioural Therapy (iCBT', 'internet-based cognitive behavioural therapy']",[],"[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.138793,A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts.,"[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Bührmann', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands. l.buhrmann@vu.nl.'}, {'ForeName': 'Josien', 'Initials': 'J', 'LastName': 'Schuurmans', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Fleuren', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Etzelmüller', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jiménez', 'Affiliation': 'Department of Research and Innovation, Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Finch', 'Affiliation': 'Department of Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Potthoff', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Aouizerate', 'Affiliation': 'Fondation FondaMental, Creteil, France.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Claus Duedal', 'Initials': 'CD', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Van der Eycken', 'Affiliation': 'GAMIAN Europe, Brussels, Belgium.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Fanaj', 'Affiliation': 'Mental Health Center Prizren, Prizren, Kosovo.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'van Genugten', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hanssen', 'Affiliation': 'University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hug', 'Affiliation': 'European Alliance Against Depression e.V., Leipzig, Germany.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Kleiboer', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mathiasen', 'Affiliation': 'Research Unit for Depression and Anxiety, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Mustafa', 'Affiliation': 'Mental Health Center Prizren, Prizren, Kosovo.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Oehler', 'Affiliation': 'Stiftung Deutsche Depressionshilfe, Leipzig, Germany.'}, {'ForeName': 'Arlinda', 'Initials': 'A', 'LastName': 'Cerga-Pashoja', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Pope', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gentiana', 'Initials': 'G', 'LastName': 'Qirjako', 'Affiliation': 'Department of Public Health, Faculty of Medicine, University of Medicine, Tirana, Albania.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Rosmalen', 'Affiliation': 'University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Sacco', 'Affiliation': 'Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3, Turin, Italy.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Samalin', 'Affiliation': 'Fondation FondaMental, Creteil, France.'}, {'ForeName': 'Mette Maria', 'Initials': 'MM', 'LastName': 'Skjøth', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Tarp', 'Affiliation': 'Centre for Telepsychiatry, Region of Southern Denmark, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'GET.ON Institute, Hamburg, Germany.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Zanalda', 'Affiliation': 'Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3, Turin, Italy.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zbukvic', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Smit', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Vis', 'Affiliation': 'Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04686-4']
2016,33120324,The effects of the Fordyce's 14 fundamentals for happiness program on happiness and caregiver burden among the family caregivers of patients with epilepsy: A randomized controlled trial.,"BACKGROUND


Caregiving to patients with epilepsy (PWE) is often very stressful for family caregivers and puts a heavy caregiver burden (CB) on them. The aim of this study was to evaluate the effects of Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE.
METHODS


This randomized controlled trial was conducted on seventy family caregivers of PWE. Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran, and randomly allocated to either an intervention or a control group. Participants in the control group received conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions. Happiness and CB in both groups were assessed at three time points, namely before, immediately after, and two months after the intervention. Data were analyzed using the SPSS program (v. 18.0).
FINDINGS


There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05). The mean scores of happiness and CB in the control group did not significantly change (P > 0.05), while the mean score of happiness significantly increased and the mean score of CB significantly decreased in the intervention group across the three measurement time points (P < 0.05). Consequently, the mean score of happiness in the intervention group was significantly greater than the control group and the mean score of CB in the intervention group was significantly less than the control group at both posttests (P < 0.01).
CONCLUSION


The Fordyce's fourteen Fundamentals for Happiness Program is effective in significantly increasing happiness and reducing CB among the family caregivers of PWE. Healthcare providers and policy makers can use this program to reduce problems among these family caregivers.",2020,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"['Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran', ""Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE"", 'patients with epilepsy (PWE', 'seventy family caregivers of PWE', 'family caregivers of patients with epilepsy']","['happiness program', ""conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions""]","['mean scores of happiness and CB', 'happiness and caregiver burden', 'mean score of happiness', 'mean score of CB', 'Happiness and CB']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",70.0,0.0376502,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"[{'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: Leila_rabiei@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Lotfizadeh', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoud_lotfizadeh@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: zzkkarimmi@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoodi1383@yahoo.com.'}]",Seizure,['10.1016/j.seizure.2020.10.013']
2017,33120356,Effects of Ice Massage Prior to an Iontophoresis Treatment Using Dexamethasone Sodium Phosphate.,"CONTEXT


Low current intensity iontophoresis treatments have increased skin perfusion over 700% from baseline potentially altering drug clearance from or diffusion to the targeted area.
OBJECTIVE


To determine the effects of a preceding 10-minute ice massage on subcutaneous dexamethasone sodium phosphate (Dex-P) concentration and skin perfusion during and after a 4-mA iontophoresis treatment.
DESIGN


Controlled laboratory study.
SETTING


Research laboratory.
PATIENTS OR OTHER PARTICIPANTS


Twenty-four participants (male = 12, female = 12; age = 25.6 [4.5] y, height = 173.9 [8.51] cm, mass = 76.11 [16.84] kg).
INTERVENTION(S)


Participants were randomly assigned into 2 groups: (1) pretreatment 10-minute ice massage and (2) no pretreatment ice massage. Treatment consisted of an 80-mA·minute (4 mA, 20 min) Dex-P iontophoresis treatment. Microdialysis probes (3 mm deep in the forearm) were used to assess Dex-P, dexamethasone (Dex), and its metabolite (Dex-Met) concentrations. Skin perfusion was measured using laser Doppler flowmetry.
MAIN OUTCOME MEASURE(S)


Microdialysis samples were collected at baseline, at conclusion of treatment, and every 20 minutes posttreatment for 60 minutes. Samples were analyzed to determine Dex-Total (Dex-Total = Dex-P + Dex + Dex-Met). Skin perfusion was calculated as a percentage change from baseline. A mixed-design analysis of variance was used to determine Dex-Total and skin perfusion difference between groups overtime.
RESULTS


There was no difference between groups (P = .476), but [Dex-Total] significantly increased over the course of the iontophoresis and posttreatment time (P < .001). Dex-P was measured in 18 of 24 participants with a mean concentration of 0.67 (1.09) μg/mL. Skin perfusion was significantly greater in the no ice treatment group (P = .002). Peak skin perfusion reached 27.74% (47.49%) and 117.39% (103.45%) from baseline for the ice and no ice groups, respectively.
CONCLUSIONS


Ice massage prior to iontophoresis does not alter the tissue [Dex-Total] even with less skin perfusion.",2020,μg/mL. Skin perfusion was significantly greater in the no ice treatment group (P = .002).,"['18 of 24 participants with a mean concentration of 0.67 (1.09', 'Twenty-four participants (male = 12, female = 12; age = 25.6 [4.5]\xa0y, height = 173.9 [8.51]\xa0cm, mass = 76.11']","['Dex-P, dexamethasone (Dex', 'Dex-P iontophoresis treatment', 'dexamethasone sodium phosphate (Dex-P) concentration and skin perfusion', 'Dexamethasone Sodium Phosphate', '80-mA·minute (4\xa0mA, 20\xa0min', 'Ice Massage', 'pretreatment 10-minute ice massage and (2)\xa0no pretreatment ice massage']","['Peak skin perfusion', 'skin perfusion', 'Dex-Total and skin perfusion difference', 'Skin perfusion']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517472', 'cui_str': '0.67'}, {'cui': 'C4517490', 'cui_str': '1.09'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",24.0,0.0407436,μg/mL. Skin perfusion was significantly greater in the no ice treatment group (P = .002).,"[{'ForeName': 'Brady M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Draper', 'Affiliation': ''}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Hyldahl', 'Affiliation': ''}, {'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Rigby', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2020-0002']
2018,33120362,Electromyographic Comparison of Flywheel Inertial Leg Curl and Nordic Hamstring Exercise Among Soccer Players.,"PURPOSE


The Nordic hamstring exercise (NHE) has been shown to considerably reduce hamstring injuries among soccer players. However, as the load in the NHE is the person's own bodyweight, it is a very heavy exercise and difficult to individualize. The flywheel inertial leg curl (FLC) could be an alternative since the eccentric overload is based on the amount of work produced in the concentric movement. Therefore, the primary aim of this study was to compare the activation in the hamstrings at long muscle lengths in the NHE and the FLC in amateur soccer players.
METHODS


Fifteen male amateur soccer players performed 5 repetitions in each exercise in a randomized and counterbalanced order. The concentric and eccentric movements were divided into lower and upper phases. Surface EMG was measured distally, proximally, and in the middle, at both muscles.
RESULTS


In the lower phase in the eccentric movement, there were no significant differences between the 2 exercises (P = .101-.826). In the lower concentric movement, the FLC led to higher activation in all parts of both the biceps femoris (31%-52%, P < .001) and the semitendinosus (20%-35%, P = .001-.023).
CONCLUSION


Both exercises activated the hamstrings similarly at long muscle lengths during eccentric contractions (Nordic hamstring, nonsignificantly higher). However, when performing concentric contractions, the FLC induced higher activations. Therefore, the FLC could be a useful alternative to the NHE and particularly suitable for weaker athletes before progressing to NHE.",2020,"In the lower concentric movement, the FLC led to higher activation in all parts of both the biceps femoris (31%-52%, P < .001) and the semitendinosus (20%-35%, P = .001-.023).
","['Fifteen male amateur soccer players', 'soccer players', 'Soccer Players', 'amateur soccer players']","['Electromyographic Comparison of Flywheel Inertial Leg Curl and Nordic Hamstring Exercise', 'FLC', 'Nordic hamstring exercise (NHE']",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],15.0,0.0219721,"In the lower concentric movement, the FLC led to higher activation in all parts of both the biceps femoris (31%-52%, P < .001) and the semitendinosus (20%-35%, P = .001-.023).
","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': ''}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vagle', 'Affiliation': ''}, {'ForeName': 'Marius Steiro', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': ''}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0921']
2019,33120478,[Clinical study on the correlation between the duration of labor and postpartum hemorrhage].,"Objective:  To study the correlation between the duration of labor and postpartum hemorrhage.  Methods:  The delivery data of singleton first-term pregnant women who delivered vaginally at Beijing Obstetrics and Gynecology Hospital from January 1, 2017 to December 31, 2017 were collected, 3 104 cases met inclusion criteria. According to the duration of the first labor (t), they were divided into two groups: t≥8 hours was the observation group, t<8 hours was the control group. In order to ensure the baseline characteristics of the subjects in the two groups were balanced, propensity score matching (PSM) was adopted, with matching ratio 1∶1. Then the observation group was divided into four subgroups: group 8-12 h, group 12-16 h, group 16-20 h, group ≥20 h. According to the presence or absence of labor intervention (oxytocin use, artificial rupture of membranes, labor analgesia), the observation group and control group were divided into non-labor intervention observation group, non-labor intervention control group, labor intervention observation group, and labor intervention control group. The case data of 3 104 subjects were analyzed and the duration of labor and atonic postpartum hemorrhage rate of each subgroup were compared with the control group.  Results:  The duration of the second stage of labor and the first+second stages of labor in the observation group (median:0.8, 13.3 hours) and its subgroups were both longer than those in the control group (median:0.6, 5.1 hours), with statistically significant differences (all  P <0.01). The rate of atonic postpartum hemorrhage in the observation group, group 16-20 h and group ≥20 h were higher than that in the control group [8.0%(124/1 552), 14.3%(41/287), 14.1%(12/85), 4.6%(72/1 552)], with significant statistical differences (all  P <0.01). The duration of the second stage of labor and the first+second stages of labor in the observation group were both longer than those in the control group, regardless of the presence or absence of labor intervention, with statistically significant differences (all  P <0.01). In both the observation group and the control group, the duration of the first stage of labor, the second stage of labor, and the first+second stages of labor with labor intervention were longer than those of the non-labor intervention, with significant statistical differences (all  P <0.01). The rate of atonic postpartum hemorrhage in the observation group with labor intervention [8.7%(110/1 263)] was higher than that in the observation group without labor intervention [4.8%(14/289)], with a statistical difference ( P <0.05).  Conclusions:  With the increase of the duration of the first stage of labor, the rate of atonic postpartum hemorrhage increases. The first stage of labor is closely related to the second stage of labor, and to a certain extent the duration of the second stage of labor increases with the length of the first stage of labor. With the increase of the duration of the first stage of labor, the rate of labor intervention and atonic postpartum hemorrhage also increase, which could serve as a clinical warning that excessive labor intervention may indicate a higher incidence of atonic postpartum hemorrhage.",2020,"The duration of the second stage of labor and the first+second stages of labor in the observation group were both longer than those in the control group, regardless of the presence or absence of labor intervention, with statistically significant differences (all  P <0.01).","['singleton first-term pregnant women who delivered vaginally at Beijing Obstetrics and Gynecology Hospital from January 1, 2017 to December 31, 2017 were collected, 3 104 cases met inclusion criteria']","['observation group and control group were divided into non-labor intervention observation group, non-labor intervention control group, labor intervention observation group, and labor intervention control group']","['rate of atonic postpartum hemorrhage', 'duration of the second stage of labor and the first+second stages of labor', 'duration of labor and postpartum hemorrhage', 'first+second stages of labor with labor intervention', 'duration of the first stage of labor', 'duration of labor and atonic postpartum hemorrhage rate']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0269899', 'cui_str': 'Atonic postpartum hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]",3104.0,0.0153594,"The duration of the second stage of labor and the first+second stages of labor in the observation group were both longer than those in the control group, regardless of the presence or absence of labor intervention, with statistically significant differences (all  P <0.01).","[{'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Han', 'Affiliation': 'Department of Perinatal Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Perinatal Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200611-00497']
2020,33120757,Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial.,"BACKGROUND


The reproductive dilemma faced by men has always been the focus of the whole society. Idiopathic asthenozoospermia (AZS), as one of the common causes of male infertility, lack of specific treatment. Traditional Chinese medicine has shown potential benefits in the management of male infertility. Yishentongluo decoction (YSTL) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of YSTL for patients with idiopathic AZS and explain the possible action mechanisms of YSTL in improving sperm motility.
METHODS


In this randomized controlled study, a total of 160 eligible patients will be assigned to YSTL group or the Levocarnitine oral solution group in a 1:1 ratio. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the the progressive (motility), sperm rate (%). Secondary outcomes will include the progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate (%). Safety outcomes will cover electrocardiogram , blood tests (including blood routine test, hepatic function, and renal function), urine routine test, and stool routine test. The semen parameters, sperm MMP test, and all the safety outcomes will be performed at the baseline, 4th, 8th and 12th week. The pregnancy outcome will be evaluated at 4 weeks after treatment.
DISCUSSION


This study will provide initial evidence regarding the efficacy and safety of YSTL in the treatment of idiopathic AZS with kidney deficiency and blood stasis pattern. In addition, potential mechanisms of YSTL in improving sperm motility will be explored based on sperm MMP test.
TRIAL REGISTRATION


Chinese Clinical Trials Register identifier, ChiCTR2000033290, registered on 26 May 2020.",2020,"Secondary outcomes will include the progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate (%).","['160 eligible patients', 'male infertility', 'patients with idiopathic AZS', 'idiopathic AZS with kidney deficiency and blood stasis pattern', 'idiopathic asthenozoospermia infertility']","['YSTL', 'Traditional Chinese medicine', 'Idiopathic asthenozoospermia (AZS', 'Levocarnitine oral solution', 'Yishentongluo decoction (YSTL', 'Yishentongluo decoction']","['progressive (motility), sperm rate ', 'efficacy and safety', 'progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate ', 'Safety outcomes will cover electrocardiogram , blood tests (including blood routine test, hepatic function, and renal function), urine routine test, and stool routine test']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C1237948', 'cui_str': 'Levocarnitine Oral Solution [Carnitor]'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0230840', 'cui_str': 'Inner mitochondrial membrane'}, {'cui': 'C0025251', 'cui_str': 'Transmembrane Potentials'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",160.0,0.173409,"Secondary outcomes will include the progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate (%).","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, NO.37 Shi-er-qiao Road, Chengdu 610075, Sichuan Province, P.R. China.'}, {'ForeName': 'Lipeng', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Reproductive Medicine, Henan Province Hospital of Traditional Chinese Medicine, NO.6 Dong-feng Road.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, NO.37 Shi-er-qiao Road, Chengdu 610075, Sichuan Province, P.R. China.'}, {'ForeName': 'Zixue', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Second Clinical Medical School, Henan University of Chinese Medicine, NO.156 Jin-shui-dong Road.'}, {'ForeName': 'Chenming', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical Medical School, Henan University of Chinese Medicine, NO.156 Jin-shui-dong Road.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Andrology, The First Affiliated Hospital of Henan University of Chinese Medicine, NO.19 Ren-min Road, Zhengzhou, Henan Province, P.R. China.'}]",Medicine,['10.1097/MD.0000000000022662']
2021,33120762,A randomized controlled trial for the effect of Modified Shenling Baizhu Powder on delaying the illness progress of COPD stable phase patients (GOLD 1-2 stages): A study protocol.,"INTRODUCTION


As one of the most prominent public health and medical problems, Chronic Obstructive Pulmonary Disease (COPD) has a serious impact on the quality of life of participants and may even be life-threatening. While modern medicine has worked well to alleviate the symptoms of COPD, the current situation with this chronic disease is not encouraging. Lung-spleen qi deficiency syndrome is one of the common forms of COPD and the traditional Chinese medicine formula Modified Shenling Baizhu Powder is very frequently used in the treatment of this syndrome. However, no direct evidence is available to support the efficacy and safety of Modified Shenling Baizhu Powder for COPD treatment.
METHODS


The study is a prospective, randomized, placebo-controlled, double-blind trial in which 270 eligible participants will be randomly assigned to either the experimental or control group in a 1:1 ratio. Both groups will receive the standard Western medication. Meanwhile, participants in the experimental group will undergo Modified Shenling Baizhu Powder, while those in the control group will undergo a matched placebo. The course of treatment is 6 months with 12 months of follow-up. Primary outcome is the forced expiratory volume in 1 second (FEV1) after bronchodi-lator use. The secondary outcomes include the declines and the between-group difference in the change from baseline to 18 months in FEV1 before bronchodilator use; the forced vital capacity (FVC), FEV1/FVC, FEV1%pred after bronchodilator use, modified British medical research council, COPD Assessment Test, St George's Respiratory Questionnaire (SGRQ); frequency, interval, duration and severity of COPD exacerbations; time to first COPD exacerbation; administration of rescue medication and a cost-effectiveness analysis; Smoking status. A safety assessment will also be performed during the trial.
DISCUSSION


The results of this trial will provide comprehensive evidence of the efficacy of Modified Shenling Baizhu Powder for early-stage COPD and the potential mechanism by which Modified Shenling Baizhu Powder acts, which may provide reference for the treatment plan of COPD participants.
TRIAL REGISTRATION


ChiCTR2000037873, Registered 2 September 2020.",2020,"The results of this trial will provide comprehensive evidence of the efficacy of Modified Shenling Baizhu Powder for early-stage COPD and the potential mechanism by which Modified Shenling Baizhu Powder acts, which may provide reference for the treatment plan of COPD participants.
","['COPD stable phase patients (GOLD 1-2 stages', '270 eligible participants']","['placebo', 'Modified Shenling Baizhu Powder']","[""forced vital capacity (FVC), FEV1/FVC, FEV1%pred after bronchodilator use, modified British medical research council, COPD Assessment Test, St George's Respiratory Questionnaire (SGRQ); frequency, interval, duration and severity of COPD exacerbations; time to first COPD exacerbation; administration of rescue medication and a cost-effectiveness analysis; Smoking status"", 'forced expiratory volume in 1 second (FEV1) after bronchodi-lator use']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",270.0,0.15092,"The results of this trial will provide comprehensive evidence of the efficacy of Modified Shenling Baizhu Powder for early-stage COPD and the potential mechanism by which Modified Shenling Baizhu Powder acts, which may provide reference for the treatment plan of COPD participants.
","[{'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Wujun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jurong', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022700']
2022,33116029,Multivariate analysis reveals oral health-related quality of life of complete denture wearers with denture adhesives: a multicenter randomized controlled trial.,"PURPOSE


To investigate the difference in improvement of oral health-related quality of life (OHR-QoL) depending on the oral and denture conditions of a complete denture wearer when using a cream or powder type denture adhesive in a 10-center parallel randomized clinical trial.
METHODS


Two hundred edentulous subjects who wore complete dentures were allocated to each of the three groups according to denture adhesive type: cream, powder, and control (saline solution). The materials were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention were collected. OHR-QoL was assessed using the Japanese version of the modified Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-J) scale for outcome. Multivariate analysis was used to investigate improvements in OHR-QoL according to participant characteristics among complete denture wearers using these materials.
RESULTS


OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups. Multiple logistic regression analysis revealed a significant association between the vertical height of the maxillary and mandibular alveolar ridge and OHIP-EDENT-J scores in the cream-type denture adhesive group. In contrast, there were no significant association between participant characteristics and OHIP-EDENT-J scores in the powder-type adhesive and control groups.
CONCLUSIONS


The use of denture adhesives could improve OHR-QoL for complete denture wearers. The cream-type denture adhesives may be expected to improve OHR-QoL in patients with poor residual ridge conditions compared with patients with good residual ridge conditions.",2020,"RESULTS


OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups.","['Two hundred edentulous subjects who wore complete dentures', 'complete denture wearers', 'complete denture wearers with denture adhesives', 'patients with poor residual ridge conditions compared with patients with good residual ridge conditions']","['denture adhesive type: cream, powder, and control (saline solution']","['OHIP-EDENT-J scores', 'oral health-related quality of life (OHR-QoL', 'OHR-QoL', 'oral health-related quality of life', 'vertical height of the maxillary and mandibular alveolar ridge and OHIP-EDENT-J scores', 'participant characteristics and OHIP-EDENT-J scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C1706094', 'cui_str': 'Dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1706094', 'cui_str': 'Dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0222747', 'cui_str': 'Structure of alveolar arch of mandible'}]",200.0,0.0458358,"RESULTS


OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups.","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Tsuboi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Gunji', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Ohwada', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hoshi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Saita', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Yoneyama', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Morokuma', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Okazaki', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ichikawa', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murata', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kurogi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'The Japan Denture Care Society.'}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'The Japan Denture Care Society.'}]",Journal of prosthodontic research,['10.2186/jpr.JPR_D_20_00132']
2023,33116073,Influence of Scapula Training Exercises on Shoulder Joint Function After Surgery for Rotator Cuff Injury.,"BACKGROUND The aim of this study was to assess the clinical effectiveness of scapula training exercises on shoulder function after surgery for rotator cuff injury. MATERIAL AND METHODS Forty-six patients with rotator cuff injury after surgery were randomized into the experiment group or control group. Both groups were treated with conventional therapeutic exercise and physical therapy, and scapular training exercise was added to the experiment group. Patient status was evaluated by Constant-Murley scale (CMS), visual analogue scale (VAS), and the active range of motion (ROM) of the shoulder before and after 6 weeks and 12 weeks of treatment. RESULTS After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05). After 12 weeks of treatment, all items in the experimental group were significantly improved compared to the control group (P<0.05). CONCLUSIONS The combination of conventional rehabilitation interventions and scapular training exercise were an effective treatment of the shoulder dysfunction. Moreover, increased Scapula training exercise had better effect on the improvement of shoulder function.",2020,"After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05).","['Forty-six patients with rotator cuff injury after surgery', 'rotator cuff injury']","['scapula training exercises', 'Scapula Training Exercises', 'conventional therapeutic exercise and physical therapy, and scapular training exercise', 'conventional rehabilitation interventions and scapular training exercise']","['Shoulder Joint Function', 'shoulder function', 'Constant-Murley scale (CMS), visual analogue scale (VAS), and the active range of motion (ROM) of the shoulder']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851122', 'cui_str': 'Injury of rotator cuff'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",46.0,0.0186742,"After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jingjie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiufang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925758']
2024,33116094,Effect of Infant Massage in Reduction of Neonatal Jaundice.,"Infant massage is a traditional practice for newborns in some parts of the world; its beneficial effects in reduction of jaundice in the neonates are a matter of investigation. This study aims to find out the effects of massage therapy in term neonates with neonatal jaundice receiving phototherapy compared with a control group. This randomized controlled trial (RCT) includes total 100 term newborns evenly divided into the massage group and control group after obtaining informed consent and was conducted in the Neonatal ward of the Sher-e-Bangla Medical College, Barisal, Bangladesh from 1st January 2018 to 30th June 2018. The massage group received both massage therapy and phototherapy for neonatal jaundice whereas the control group received only phototherapy. Data were collected and analyzed and results were prepared by student's 't' test for continuous variables and chi-square test for categorical variables and statistical significance was found if p value <0.05. Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05). The defecation frequency was significantly more in massage group than control group and serum bilirubin levels were significantly lower in massage group than control group on day 3 onward (p<0.05). Infant massage is a safe, effective and economic practice, which can be an adjunct to phototherapy in the management of neonatal jaundice.",2020,"Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05).","['term neonates with neonatal jaundice receiving phototherapy compared with a control group', 'total 100 term newborns evenly divided into the massage group and control group after obtaining informed consent and was conducted in the Neonatal ward of the Sher-e-Bangla Medical College, Barisal, Bangladesh from 1st January 2018 to 30th June 2018']","['massage therapy', 'control group received only phototherapy', 'Infant Massage', 'massage therapy and phototherapy', 'Infant massage']","['Neonatal Jaundice', 'serum bilirubin levels', 'defecation frequency']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0004981', 'cui_str': 'Bengali language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0205435', 'cui_str': 'First'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0695595', 'cui_str': 'Infant massage'}]","[{'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",100.0,0.012086,"Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Amin', 'Affiliation': 'Dr Tahsinul Amin, Associate Professor, Department of Neonatology, Sher-e-Bangla Medical College, Barisal, Bangladesh; E-mail: tahsinul_amin@yahoo.com.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Nur', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2025,33116098,Medical Undergraduates' Written Assessment Profile of Illustration-based Neuroanatomy.,"Neuroanatomy is an integral part of Anatomy and it is one of the most visually dependent and visually-demanding one. Analysis of recent trends of emphasizing the importance of illustrations which are being reflected in the learning pattern or student-assessment can provide an insight into the situation and help teachers and curriculum planners. Thus, the present study was planned i) to analyze the Neuroanatomy portion of the recent undergraduate Anatomy written question papers of four public universities of Bangladesh for understanding how the ability to draw and label has been assessed in the questions and ii) to determine the ability of the undergraduate students to answer illustration-based questions as compared to their ability to answer non-illustration-based (text-based) questions in Neuroanatomy. For Part-A of the study, all the 'segment's of item (SAQ and MCQ) dealing with Neuroanatomy in all the available Anatomy written question papers of all the First Professional MBBS Exams of four public universities of Bangladesh of the last five years (2005 to 2009) were identified. The frequency of 'segment's those were assessing the ability to draw and label was determined. For Part-B of the study, 214 students were taken as participants. They were divided into two equal groups by randomization. The first group was given 100 illustration-based questions based on the illustrations representing different 'purpose's and 'form's in Snell1. The other group was given 100 non-illustration-based questions on the corresponding textual material. The scores of the two corresponding groups were compared using an unpaired 't' test. The frequency of segments was assessing the ability to draw and label was 3.86%. The performance of the undergraduates answering illustration-based questions was significantly poorer (p=0.0) than non-illustration-based questions (mean±SD being 23.36±14.02 and 44.75±9.50 respectively). Teaching and assessment of Neuroanatomy should be planned in a way to orient undergraduates towards more illustration-based understanding and performance. Necessary modifications in the curriculum are recommended.",2020,The performance of the undergraduates answering illustration-based questions was significantly poorer (p=0.0) than non-illustration-based questions (mean±SD being 23.36±14.02 and 44.75±9.50 respectively).,['214 students were taken as participants'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",[],[],214.0,0.0132591,The performance of the undergraduates answering illustration-based questions was significantly poorer (p=0.0) than non-illustration-based questions (mean±SD being 23.36±14.02 and 44.75±9.50 respectively).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Akter', 'Affiliation': 'Major (Dr) Manowara Akter, GSO-2 (Coordination), Army Medical Corps Centre & School, Ghatail Cantonment, Ghatail, Tangail, Bangladesh; E-mail: kamaldu7810@gmail.com.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sharmin', 'Affiliation': ''}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Amin', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2026,33116101,The Additive Effects of Midazolam in Sub Arachnoid Block in Elective Caesarian Section: A Randomized Control Trial.,"The incidence of visceral pain among caesarean section can be as high as 50% in sub arachnoid block (SAB) in spite adequate sensory block, which requires conversion to general anesthesia. Different types of adjuvant have been used to augment the effect of local anesthetics but their use is limited due to adverse effects. The effect of intrathecal midazolam along with hyperbaric bupivacaine in sub arachnoid block is less known. So this randomized, double blind study was conducted to evaluate the additive effect of 0.4ml midazolam to 0.5% 3ml bupivacaine on sub arachnoid block in scheduled elective caesarean section. This study demonstrated that the addition of intrathecal 0.4ml midazolam to spinal 0.5% bupivacaine kept all the characteristics of block unaffected, furthermore pain score VAS 3.4±1.3 in Group A and 1.8±1.22 in Group B which is statistically significant, the requirement of intraoperative analgesia and also increased the duration of postoperative analgesia that is 130.3±5.4 minute in Group A, 265.1±3.6 minute in Group B and also statistically significant. Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.",2020,"Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.","['scheduled elective caesarean section', 'Elective Caesarian Section']","['bupivacaine', 'hyperbaric bupivacaine', 'intrathecal 0.4ml midazolam', 'intrathecal midazolam', 'midazolam', 'Midazolam']","['furthermore pain score VAS', 'duration of postoperative analgesia', 'VAS score', 'visceral pain', 'intraoperative analgesia', 'intraoperative visceral pain and need of analgesia']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",,0.39745,"Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Alam', 'Affiliation': 'Professor Dr ABM Muksudul Alam, Professor of Anaesthesiology, Department of Anaesthesiology, Shaheed Suhrawardy Medical College (SSMC), Dhaka, Bangladesh.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Deeba', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Matin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ivy', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2027,33116241,Innate local response and tissue recovery following application of high density microarray patches to human skin.,"The development of microarray patches for vaccine application has the potential to revolutionise vaccine delivery. Microarray patches (MAP) reduce risks of needle stick injury, do not require reconstitution and have the potential to enhance immune responses using a fractional vaccine dose. To date, the majority of research has focused on vaccine delivery with little characterisation of local skin response and recovery. Here we study in detail the immediate local skin response and recovery of the skin post high density MAP application in 12 individuals receiving 3 MAPs randomly assigned to the forearm and upper arm. Responses were characterised by clinical scoring, dermatoscopy, evaporimetry and tissue viability imaging (TiVi). MAP application resulted in punctures in the epidermis, a significant transepidermal water loss (TEWL), the peak TEWL being concomitant with peak erythema responses visualised by TiVi. TEWL and TiVi responses reduced over time, with TEWL returning to baseline by 48 h and erythema fading over the course of a 7 day period. As MAPs for vaccination move into larger clinical studies more variation of individual subject phenotypic or disease propensity will be encountered which will require consideration both in regard to reliability of dose delivery and degree of inherent skin response.",2020,"MAP application resulted in punctures in the epidermis, a significant transepidermal water loss (TEWL), the peak TEWL being concomitant with peak erythema responses visualised by TiVi. TEWL and TiVi responses reduced over time, with TEWL returning to baseline by 48 h and erythema fading over the course of a 7 day period.","['12 individuals receiving 3 MAPs randomly assigned to the forearm and upper arm', 'human skin']",['skin post high density MAP application'],"['clinical scoring, dermatoscopy, evaporimetry and tissue viability imaging (TiVi', 'transepidermal water loss (TEWL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C1449935', 'cui_str': 'Tissue Viability'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.0333851,"MAP application resulted in punctures in the epidermis, a significant transepidermal water loss (TEWL), the peak TEWL being concomitant with peak erythema responses visualised by TiVi. TEWL and TiVi responses reduced over time, with TEWL returning to baseline by 48 h and erythema fading over the course of a 7 day period.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Muller', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Building 76 Cooper road, St. Lucia, QLD, 4072, Australia. d.muller4@uq.edu.au.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Henricson', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'S Ben', 'Initials': 'SB', 'LastName': 'Baker', 'Affiliation': 'Vaxxas Pty Ltd, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD, 4102, Australia.'}, {'ForeName': 'Totte', 'Initials': 'T', 'LastName': 'Togö', 'Affiliation': 'Allergy Center Linköping, Region Östergötland, Sweden.'}, {'ForeName': 'Cesar M', 'Initials': 'CM', 'LastName': 'Jayashi Flores', 'Affiliation': 'Vaxxas Pty Ltd, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD, 4102, Australia.'}, {'ForeName': 'Pierre A', 'Initials': 'PA', 'LastName': 'Lemaire', 'Affiliation': 'Vaxxas Pty Ltd, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD, 4102, Australia.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Vaxxas Pty Ltd, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD, 4102, Australia.'}, {'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Anderson', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. chris.anderson@regionostergotland.se.'}]",Scientific reports,['10.1038/s41598-020-75169-4']
2028,33116441,An Evaluation of the Video Narrative Technique on the Self-Efficacy of Medication Understanding and Use Among Post-Stroke Patients: A Randomized-Controlled Trial.,"Introduction


Self-efficacy is positively associated with medication understanding and use self-efficacy (MUSE) among post-stroke patients. It is also closely related to knowledge, belief, and perception, which vary among people from different socioeconomic backgrounds and cultures. As interventions using video and peer stories have emerged to be successful on behavior modification, this study aimed to explore the effectiveness of video narratives incorporated with Health Belief constructs on MUSE and its associated factors among patients with stroke at a local setting.
Methods


A randomized controlled trial (RCT) for 12 months was carried out on patients diagnosed with stroke at Hospital Kuala Lumpur, Malaysia. The RCT recruited up to 216 eligible patients who were requested to return for two more follow-ups within six months. Consented patients were randomized to either standard care or intervention with video narratives. The control of potential confounding factors was ensured, as well as unbiased treatment review with prescribed medications, only obtained onsite.
Results and Discussion


A repeated measure of MUSE mean score differences at T0 (baseline), T2 (6th month) and T4 (12th month) for antithrombotic, antihypertensive, and all medication categories indicated significant within and between groups differences in the intervention group (p<0.05). Moreover, this impact was reflected upon continuous blood pressure (BP) monitoring compared to the control group (F (1214) =5.23, p=0.023, ƞ2=0.024). Though BP measure differences were non-significant between the groups (p=0.552), repeated measure analysis displayed significant mean differences between intervention and control group on BP control over time (F (1.344, 287.55) =8.54, P<0.001, ƞ2=0.038). Similarly, the intervention's positive impact was also present with similar trends for knowledge, illness perception, and the belief about medicine. Though significant differences (p<0.05) of all outcome measures gradually decreased between T2 and T4 in the intervention group; nevertheless, these positive findings confirmed that personalized video narratives were able to motivate and influence MUSE and its associated factors among post-stroke patients. The significant improvement in medication-taking self-efficacy and the sustenance of BP monitoring habits among patients in the intervention group strengthened our conceptual framework's practicality.",2020,The significant improvement in medication-taking self-efficacy and the sustenance of BP monitoring habits among patients in the intervention group strengthened our conceptual framework's practicality.,"['post-stroke patients', '216 eligible patients who were requested to return for two more follow-ups within six months', 'patients diagnosed with stroke at Hospital Kuala Lumpur, Malaysia', 'Post-Stroke Patients', 'patients with stroke at a local setting']",['standard care or intervention with video narratives'],"['continuous blood pressure (BP) monitoring', 'medication-taking self-efficacy and the sustenance of BP monitoring habits']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0480055,The significant improvement in medication-taking self-efficacy and the sustenance of BP monitoring habits among patients in the intervention group strengthened our conceptual framework's practicality.,"[{'ForeName': 'Jamuna Rani', 'Initials': 'JR', 'LastName': 'Appalasamy', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Kia Fatt', 'Initials': 'KF', 'LastName': 'Quek', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Anuar Zaini', 'Initials': 'AZ', 'LastName': 'Md Zain', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Joyce Pauline', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of Neurology, Hospital Kuala Lumpur, Ministry of Health, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Seeta Ramaiah', 'Affiliation': 'Medical Department, Subang Jaya Medical Center, Sunway, Malaysia.'}, {'ForeName': 'Kyi Kyi', 'Initials': 'KK', 'LastName': 'Tha', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}]",Patient preference and adherence,['10.2147/PPA.S253918']
2029,33116455,Efficacy and Safety of the CFTR Potentiator Icenticaftor (QBW251) in COPD: Results from a Phase 2 Randomized Trial.,"Rationale


Excess mucus plays a key role in COPD pathogenesis. Cigarette smoke-induced cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction may contribute to disease pathogenesis by depleting airway surface liquid and reducing mucociliary transport; these defects can be corrected in vitro by potentiating CFTR.
Objective


To assess the efficacy of the CFTR potentiator icenticaftor in improving airflow obstruction in COPD patients with symptoms of chronic bronchitis.
Methods


In this double-blind, placebo-controlled study, COPD patients were randomized (2:1) to either icenticaftor 300 mg or placebo b.i.d. This non-confirmatory proof of concept study was powered for lung clearance index (LCI) and pre-bronchodilator FEV 1 , with an estimated sample size of 90 patients. The primary endpoint was change from baseline in LCI for icenticaftor versus placebo at Day 29; key secondary endpoints included change from baseline in pre- and post-bronchodilator FEV 1  on Day 29. Key exploratory endpoints included change from baseline in sweat chloride, plasma fibrinogen levels, and sputum colonization.
Results


Ninety-two patients were randomized (icenticaftor, n=64; placebo, n=28). At Day 29, icenticaftor showed no improvement in change in LCI (treatment difference: 0.28 [19% probability of being better than placebo]), an improvement in pre-bronchodilator FEV 1  (mean: 50 mL [84% probability]) and an improvement in post-bronchodilator FEV 1  (mean: 63 mL [91% probability]) over placebo. Improvements in sweat chloride, fibrinogen and sputum bacterial colonization were also observed. Icenticaftor was safe and well tolerated.
Conclusion


The CFTR potentiator icenticaftor increased FEV 1  versus placebo after 28 days and was associated with improvements in systemic inflammation and sputum bacterial colonization in COPD patients; no improvements in LCI with icenticaftor were observed.",2020,The CFTR potentiator icenticaftor increased FEV 1  versus placebo after 28 days and was associated with improvements in systemic inflammation and sputum bacterial colonization in COPD patients; no improvements in LCI with icenticaftor were observed.,"['COPD patients', 'Ninety-two patients were randomized (icenticaftor, n=64', 'COPD', 'COPD patients with symptoms of chronic bronchitis']","['CFTR potentiator icenticaftor', 'placebo', 'icenticaftor\xa0300 mg or placebo', 'CFTR Potentiator\xa0Icenticaftor (QBW251']","['sweat chloride, plasma fibrinogen levels, and sputum colonization', 'systemic inflammation and sputum bacterial colonization', 'airflow obstruction', 'Efficacy and Safety', 'change from baseline in LCI', 'safe and well tolerated', 'CFTR potentiator icenticaftor\xa0increased FEV', 'change in LCI', 'sweat chloride, fibrinogen and sputum bacterial colonization']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008677', 'cui_str': 'Chronic bronchitis'}]","[{'cui': 'C4521703', 'cui_str': 'Cystic fibrosis transmembrane conductance regulator potentiator'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C4521703', 'cui_str': 'Cystic fibrosis transmembrane conductance regulator potentiator'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}]",92.0,0.43372,The CFTR potentiator icenticaftor increased FEV 1  versus placebo after 28 days and was associated with improvements in systemic inflammation and sputum bacterial colonization in COPD patients; no improvements in LCI with icenticaftor were observed.,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Ieuan', 'Initials': 'I', 'LastName': 'Jones', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Nazmul', 'Initials': 'N', 'LastName': 'Haque', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gleason', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Katy A', 'Initials': 'KA', 'LastName': 'Hayes', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kulmatycki', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Yates', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Danahay', 'Affiliation': 'Enterprise Therapeutics, Brighton, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gosling', 'Affiliation': 'Enterprise Therapeutics, Brighton, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Rowlands', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Grant', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S257474']
2030,33116533,The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China.,"Background


Major depressive disorder (MDD) is a heterogeneous mental disease that encompasses different subtypes and specifiers. Clinically targeted treatments have not been identified yet, although standardized strategies are recommended by several clinical guidelines. The main aim of this study is to respectively identify the precise treatment for three different subtypes of MDD (ie, melancholic, atypical, and anxious).
Methods


An 8-to-12-week, multicenter randomized controlled trial (RCT) with a parallel group design will be conducted to determine the most effective and appropriate treatment. A total of 750 adults diagnosed with MDD will be recruited, categorized into melancholic, atypical or anxious type based on the assessment of the Inventory of Depressive Symptomatology (IDS30) and the Hamilton Anxiety Scale (HAMA), and 1:1 randomly assigned to different intervention groups. Blood draw, EEG test, and MRI scan will be performed at baseline and endpoint. Clinical symptom and side-effects will be evaluated at critical decision points (CDP) including weeks two, four, six, eight, and 12 after treatment. The primary outcome is total score and reduction rate of the 17-Hamilton Depression Rating Scale (17-HDRS). The secondary outcomes include the scores of the Quick Inventory of Depressive Symptomatology-self-report (QIDS-SR), IDS30, HAMA and the Treatment Emergent Symptom Scale (TESS). All the data will be analyzed by SAS software.
Discussion


The study commenced recruitment in August 2017 and is currently ongoing.
Trial Registration


ClinicalTrials.gov Identifier: NCT03219008 (July 17, 2017).",2020,"The secondary outcomes include the scores of the Quick Inventory of Depressive Symptomatology-self-report (QIDS-SR), IDS30, HAMA and the Treatment Emergent Symptom Scale (TESS).","['Major Depressive Disorder', '750 adults diagnosed with MDD will be recruited, categorized into melancholic, atypical or anxious type based on the assessment of the Inventory of Depressive Symptomatology (IDS30) and the Hamilton Anxiety Scale (HAMA']",[],"['total score and reduction rate of the 17-Hamilton Depression Rating Scale (17-HDRS', 'scores of the Quick Inventory of Depressive Symptomatology-self-report (QIDS-SR), IDS30, HAMA and the Treatment Emergent Symptom Scale (TESS', 'Clinical symptom and side-effects', 'Blood draw, EEG test, and MRI scan']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",750.0,0.135648,"The secondary outcomes include the scores of the Quick Inventory of Depressive Symptomatology-self-report (QIDS-SR), IDS30, HAMA and the Treatment Emergent Symptom Scale (TESS).","[{'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Daihui', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': ""Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Yanqun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Yun-Ai', 'Initials': 'YA', 'LastName': 'Su', 'Affiliation': ""Department of Psychiatry, Peking University Sixth Hospital, Peking, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Psychiatry, Harbin First Specific Hospital, Harbin, People's Republic of China.""}, {'ForeName': 'Xiancang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Psychiatry, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Psychiatry, Wuhan Mental Health Center, Wuhan, People's Republic of China.""}, {'ForeName': 'Jianfei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Psychiatry, Hangzhou Seventh People's Hospital, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Psychiatry, Shandong Mental Health Center, Shandong, People's Republic of China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': ""Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, People's Republic of China.""}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S271842']
2031,33116802,Effects of Adding a Combined Infraorbital and Infratrochlear Nerve Block to General Anaesthesia in Septorhinoplasty.,"Purpose


In this study, we evaluated the hypothesis that preoperative bilateral infraoptic nerve (ION) and infratrochlear nerve (ITN) blocks under general anesthesia with sevoflurane and remifentanil reduced the incidence of emergence agitation (EA), pain scores, and the analgesic consumption after the septorhinoplasty.
Patients and Methods


Our study was conducted as a prospective randomized, double-sided blind study. Fifty-two patients whose septorhinoplasty operation was planned under general anesthesia were included in the study. Patients were randomly distributed to either the ION and ITN blocks were performed. Group 1: Bilateral ION and ITN blocks were performed; Group 2: ION and ITN blocks were not performed. Duration of the surgery and anesthesia, Riker Sedation-Agitation Scale (RSAS) score, EA presence, duration of postoperative analgesia, numerical rating scale (NRS) scores, and cumulative dexketoprofen consumption were recorded.
Results


The RSAS score, NRS score and cumulative dexketoprofen consumption of the patients in Group 1 were statistically significantly lower than the patients in Group 2 (p<0.05). It was also found that patients in Group 1 (n: 8/26) had less EA compared to patients in Group 2 (n: 16/26) and this difference was statistically significant (p: 0.026). Postoperative analgesia duration of patients in Group 1 was found to be statistically significantly higher than patients in Group 2 (p: <0.001). In addition, the number of patients given postoperative dexketoprofen in Group 1 (n: 8/26) was found to be statistically significantly lower than patients in Group 2 (n: 25/26). (p: <0.001).
Conclusion


Bilateral ION and ITN blocks in septorhinoplasty operation is an effective, reliable and simple technique in the treatment of postoperative pain.",2020,Postoperative analgesia duration of patients in Group 1 was found to be statistically significantly higher than patients in Group 2 (p: <0.001).,['Fifty-two patients whose septorhinoplasty operation was planned under general anesthesia were included in the study'],"['dexketoprofen', 'sevoflurane and remifentanil', 'preoperative bilateral infraoptic nerve (ION) and infratrochlear nerve (ITN) blocks', 'Combined Infraorbital and Infratrochlear Nerve Block']","['RSAS score, NRS score and cumulative dexketoprofen consumption', 'Postoperative analgesia duration', 'incidence of emergence agitation (EA), pain scores, and the analgesic consumption', 'Duration of the surgery and anesthesia, Riker Sedation-Agitation Scale (RSAS) score, EA presence, duration of postoperative analgesia, numerical rating scale (NRS) scores, and cumulative dexketoprofen consumption']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0228717', 'cui_str': 'Structure of infratrochlear nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",52.0,0.0525745,Postoperative analgesia duration of patients in Group 1 was found to be statistically significantly higher than patients in Group 2 (p: <0.001).,"[{'ForeName': 'Cem Kıvılcım', 'Initials': 'CK', 'LastName': 'Kaçar', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Uzundere', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}, {'ForeName': 'Fikret', 'Initials': 'F', 'LastName': 'Salık', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Akgündüz', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}, {'ForeName': 'Esra Aktiz', 'Initials': 'EA', 'LastName': 'Bıçak', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Yektaş', 'Affiliation': 'Anaesthesiology and Reanimation Clinic, Gazi Yaşargil Education and Research Hospital, TR Health Sciences University, Diyarbakır, Turkey.'}]",Journal of pain research,['10.2147/JPR.S255720']
2032,33116803,Ultrasound-Guided Rectus Sheath Block Combined with Butorphanol for Single-Incision Laparoscopic Cholecystectomy: What is the Optimal Dose of Ropivacaine?,"Purpose


In recent years, ultrasound-guided rectus sheath block (RSB) has been widely used in postoperative analgesia of abdominal operation. However, there is no uniform standard for the optimal dose of local anesthetics (LA) under ultrasound-guided rectus sheath block. This study aimed to determine the dose of ropivacaine combined with butorphanol that is effective in 50% (ED50) and 95% (ED95) of subjects for successful pain-free ultrasound-guided RSB in single-incision laparoscopic cholecystectomy (SILC).
Patients and Methods


Twenty-four patients scheduled to undergo single-incision laparoscopic cholecystectomy received an ultrasound-guided RSB. The initial dose of ropivacaine injected was 1.7 mg/kg, which was subsequently increased or decreased by 0.2 mg/kg, depending on whether the previous patient was free from pain (numeric rating scale (NRS) score of incisional pain at rest within 12 h after operation ≤ 3). All patients were treated with butorphanol 0.02 mg/kg as preemptive analgesia. The ED50 and ED95 were calculated using a probit regression model.
Results


The ED50 and ED95 of ropivacaine combined with butorphanol in ultrasound-guided rectus sheath block for analgesia in SILC, which were calculated by the probit regression model, were 0.719 mg/kg (95% confidence interval (CI), 0.553 mg/kg-0.873 mg/kg) and 0.967 mg/kg (95% CI, 0.835 mg/kg-1.91 mg/kg), respectively.
Conclusion


As part of a multimodal analgesia strategy, a dose of 0.719 mg/kg ropivacaine provided successful RSB under ultrasound guidance in 50% of the patients who underwent SILC. A dose of 0.967 mg/kg would be successful in 95% of patients.",2020,"The ED50 and ED95 of ropivacaine combined with butorphanol in ultrasound-guided rectus sheath block for analgesia in SILC, which were calculated by the probit regression model, were 0.719 mg/kg (95% confidence interval (CI), 0.553 mg/kg-0.873 mg/kg) and 0.967 mg/kg (95% CI, 0.835 mg/kg-1.91 mg/kg), respectively.
","['50% (ED50) and 95% (ED95) of subjects for successful pain-free ultrasound-guided RSB in single-incision laparoscopic cholecystectomy (SILC', 'Single-Incision Laparoscopic Cholecystectomy']","['butorphanol 0.02 mg/kg as preemptive analgesia', 'local anesthetics (LA', 'butorphanol', 'ropivacaine', 'Ultrasound-Guided Rectus Sheath Block Combined with Butorphanol', 'ultrasound-guided rectus sheath block (RSB', 'Ropivacaine', 'single-incision laparoscopic cholecystectomy received an ultrasound-guided RSB']",['pain (numeric rating scale (NRS) score of incisional pain'],"[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]",24.0,0.110214,"The ED50 and ED95 of ropivacaine combined with butorphanol in ultrasound-guided rectus sheath block for analgesia in SILC, which were calculated by the probit regression model, were 0.719 mg/kg (95% confidence interval (CI), 0.553 mg/kg-0.873 mg/kg) and 0.967 mg/kg (95% CI, 0.835 mg/kg-1.91 mg/kg), respectively.
","[{'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xingguo', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S265418']
2033,33116807,Moxibustion for Patients with Primary Dysmenorrhea at Different Intervention Time Points: A Randomized Controlled Trial.,"Purpose


To investigate the effectiveness of moxibustion at different times of the menstrual cycle for patients with primary dysmenorrhea (PD).
Patients and Methods


Participants were 208 patients allocated to three controlled groups: one pre-menstrual treatment group (Group A), one menstrual-onset treatment group (Group B), and one waiting-list group (Group C). Groups A and B received the same intervention of moxibustion on points SP6 and RN4 but at different times. Group C, the waiting-list group, received no treatment throughout the study. Cox Menstrual Symptom Scale (CMSS) score was the primary outcome. Secondary outcomes were visual analog scale (VAS) score of pain intensity, self-rating anxiety scale (SAS) score, and self-rating depression scale (SDS) score. CMSS and VAS scores were obtained at the baseline stage (three cycles), treatment stage (three cycles), and follow-up stage (three cycles), a total of seven evaluations. SAS and SDS scores were obtained on the day of group allocation and the first day of the follow-up stage, a total of two evaluations.
Results


Baseline characteristics were comparable across the three groups. Pain duration (CMSS score) was significantly higher in Group C than in the other two groups at each evaluation (P<0.001). There was also a significant difference in the improvement in pain duration between Group B and Group C (P<0.001) throughout the trial. There were no significant changes in pain severity (CMSS score) after the 3-month treatment in Group A and Group B (P>0.05). Secondary outcomes showed that pre-menstrual moxibustion (Group A) was as effective as menstrual-onset moxibustion (Group B) in relieving pain intensity (VAS score) and negative mood (SDS and SAS scores).
Conclusion


Moxibustion appears as an effective treatment for PD. Pre-menstrual application is more effective than menstrual-onset application.
Trial Registration Chictrorgcn Identifier


ChiCTR-TRC-14004627.",2020,There were no significant changes in pain severity (CMSS score) after the 3-month treatment in Group A and Group B (P>0.05).,"['patients with primary dysmenorrhea (PD', 'Patients with Primary Dysmenorrhea at Different Intervention Time Points', 'Patients and Methods\n\n\nParticipants were 208 patients allocated to three controlled groups']","['one pre-menstrual treatment group (Group A), one menstrual-onset treatment group (Group B), and one waiting-list group', 'pre-menstrual moxibustion', 'Moxibustion', 'moxibustion']","['relieving pain intensity (VAS score) and negative mood (SDS and SAS scores', 'effective as menstrual-onset moxibustion', 'Cox Menstrual Symptom Scale (CMSS) score', 'CMSS and VAS scores', 'SAS and SDS scores', 'Pain duration (CMSS score', 'visual analog scale (VAS) score of pain intensity, self-rating anxiety scale (SAS) score, and self-rating depression scale (SDS) score', 'pain severity (CMSS score', 'pain duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",208.0,0.0884563,There were no significant changes in pain severity (CMSS score) after the 3-month treatment in Group A and Group B (P>0.05).,"[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Liu', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Xiao-Ji', 'Initials': 'XJ', 'LastName': 'Li', 'Affiliation': 'Natural Harmony Clinic, Auckland City, New Zealand.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Guo', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Zhu', 'Affiliation': ""Department of Traditional Chinese Medicine, Guangzhou Development District Hospital, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Fei-Fei', 'Initials': 'FF', 'LastName': 'Gao', 'Affiliation': ""Geriatrics Department, Tianjin Integrated Traditional Chinese and Western Medicine Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Fan-Rong', 'Initials': 'FR', 'LastName': 'Liang', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Si-Yi', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S270698']
2034,33116956,"Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital ®  Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.","Purpose


The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital ® ) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels.
Patients and Methods


This double-blind, randomized study evaluated the safety and efficacy of subjects randomly assigned to 12 weeks of daily intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel (n=78). The efficacy evaluation was performed using data from all included subjects who fulfilled entry criteria.
Results


Both treatments induced statistically significant reductions in the severity of the MBS from baseline until 4 weeks (Vagivital mean reduction 0.90, p=0.0000; Oxytocin mean reduction 0.82, p=0.0000) and 12 weeks post baseline (Vagivital mean reduction 1.28, p=0.0000; Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point. No serious adverse events were reported in the Aqueous Hypromellose-based vaginal gel group during the treatment period, but one (breast cancer) was reported in the oxytocin gel group (assessed as unlikely related to the study compound).
Conclusion


Significant reductions in the severity of the MBS were seen in both the Aqueous Hypromellose-based vaginal gel and the oxytocin gel groups, but with no significant differences in severity reduction seen between the groups. Both gels were safe and well tolerated. Given the benefits of avoiding the use of hormones, Aqueous Hypromellose-based vaginal gel is an attractive first choice in the treatment of postmenopausal women with vulvovaginal atrophy symptoms.",2020,"Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point.","['Postmenopausal Women with Symptoms of Vulvovaginal Atrophy', 'postmenopausal women with vulvovaginal atrophy symptoms', 'subjects who fulfilled entry criteria']","['Oxytocin Gel and an Equivalent Gel', 'Aqueous Hypromellose-based vaginal (Vagivital ® ) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel', 'oxytocin gel', 'Oxytocin', 'intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel', 'Hormonal Ingredients (Vagivital ®  Gel', 'hormones, Aqueous Hypromellose-based vaginal gel']","['Safety and Efficacy', 'MBS severity', 'safety and efficacy', 'severity of the MBS', 'vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels', 'safe and well tolerated', 'bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity', 'severity reduction', 'serious adverse events']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0221910', 'cui_str': 'Squamous epithelial cell'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0673869,"Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Fianu Jonasson', 'Affiliation': 'Department of Clinical Sciences, Intervention and Technology, Division of Obstetrics and Gynecology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bixo', 'Affiliation': 'Department of Clinical Sciences, Obstetrics and Gynecology, Umea University, Umea, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Sundström Poromaa', 'Affiliation': ""Research Group; Reproductive Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Åstrom', 'Affiliation': 'StatCons, Malmo, Sweden.'}]","Medical devices (Auckland, N.Z.)",['10.2147/MDER.S265824']
2035,33117015,Effects of Patient-Directed Interactive Music Therapy on Sleep Quality in Postoperative Elderly Patients: A Randomized-Controlled Trial.,"Purpose


This study aimed to investigate the effects of patient-directed interactive music on saliva melatonin levels and sleep quality among postoperative elderly patients in the intensive care unit (ICU).
Patients and Methods


A total of 133 elderly patients were randomized into three groups: interactive music therapy (IMT), passive listening (PL), and the control group. The control group (n = 45) received routine medical care, while IMT and PL groups received music therapy on ICU day 1. The IMT group received up to 20 mins of interactive music sessions, including relaxation techniques. The PL group received only pre-selected relaxing music-listening for 30 mins. Saliva melatonin and cortisol levels were measured three times at 11 p.m. (preoperative, operation day, and postoperative day [POD] 1). The Richards-Campbell Sleep Questionnaire (RCSQ) and Quality of Recovery-40 questionnaire (QoR40) were administered on the preoperative day, as well as PODs 1 and 2.
Results


The RCSQ showed a significant improvement in the IMT group compared to the control group on POD2 (71.50 vs 56.89, p=0.012), but the QoR40 did not show any difference between groups. The quality control of the saliva sample was not available due to the immediate postoperative patient's condition, resulting in a higher dropout rate. Saliva melatonin levels on POD 1 were elevated in the IMT group compared to the control group (1.45 vs 0.04, p=0.0068). The cortisol level did not show a significant difference between groups.
Conclusion


Single IMT intervention improved subjectively assessed short-term sleep quality in postoperative elderly patients. It is difficult to conclude whether music therapy intervention affects the level of melatonin and cortisol.
Trial Registration


The study was registered at ClinicalTrials.Gov (number NCT03156205).",2020,"Saliva melatonin levels on POD 1 were elevated in the IMT group compared to the control group (1.45 vs 0.04, p=0.0068).","['postoperative elderly patients', 'Patients and Methods\n\n\nA total of 133 elderly patients', 'postoperative elderly patients in the intensive care unit (ICU', 'Postoperative Elderly Patients']","['routine medical care, while IMT and PL groups received music therapy', 'IMT', 'IMT intervention', 'interactive music therapy (IMT), passive listening (PL), and the control group', 'patient-directed interactive music', 'music therapy intervention', 'Patient-Directed Interactive Music Therapy', 'interactive music sessions, including relaxation techniques']","['level of melatonin and cortisol', 'Saliva melatonin levels on POD 1', 'saliva melatonin levels and sleep quality', 'POD2', 'cortisol level', 'Richards-Campbell Sleep Questionnaire (RCSQ) and Quality of Recovery-40 questionnaire (QoR40', 'subjectively assessed short-term sleep quality', 'Sleep Quality', 'Saliva melatonin and cortisol levels']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1454475', 'cui_str': 'TCF21 protein, human'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",133.0,0.0911414,"Saliva melatonin levels on POD 1 were elevated in the IMT group compared to the control group (1.45 vs 0.04, p=0.0068).","[{'ForeName': 'Jeongmin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dain', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Department of Music Therapy, Graduate School, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Sun', 'Initials': 'MS', 'LastName': 'Yeo', 'Affiliation': 'Department of Music Therapy, Graduate School, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Ga Eul', 'Initials': 'GE', 'LastName': 'Yoo', 'Affiliation': 'Department of Music Therapy, Graduate School, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Ji', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Music Therapy Education, Graduate School of Education, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Na', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Nature and science of sleep,['10.2147/NSS.S286375']
2036,33117131,Effects of rTMS Treatment on Cognitive Impairment and Resting-State Brain Activity in Stroke Patients: A Randomized Clinical Trial.,"Background


Repetitive transcranial magnetic stimulation (rTMS) has been employed for motor function rehabilitation for stroke patients, but its effects on post-stroke cognitive impairment (PSCI) remains controversial.
Objective


To identify the effects of rTMS intervention on PSCI patients and its potential neural correlates to behavioral improvements.
Methods


We recruited 34 PSCI patients for 20 sessions of 10 Hz rTMS or no-stim control treatments over the left dorsal lateral prefrontal cortex (DLPFC). Cognitive function was evaluated with the Montreal Cognitive Assessment Scale, Victoria Stroop Test, Rivermead Behavior Memory Test, and Activities of Daily Living (ADL) assessed with the Modified Barthel Index. 14 patients received functional MRI scan, a useful non-invasive technique of determining how structurally segregated and functionally specialized brain areas were interconnected, which was reflected by blood oxygenation level-dependent signals. The amplitude of low-frequency fluctuation (ALFF) and functional connectivity (FC) were applied as the analytical approaches, which were used to measure the resting-state brain activity and functional connection.
Results


rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment. The cognitive improvements correlated to increased ALFF of the left medial prefrontal cortex, and increased FC of right medial prefrontal cortex and right ventral anterior cingulate cortex.
Conclusion


10 Hz rTMS at DLPFC could improve cognitive function and quality of life for PSCI patients, which is associated with an altered frontal cortical activity.
Clinical Registration


Chinese Clinical Trial Registry, ChiCTR-IPR-17011908, http://www.chictr.org.cn/index.aspx.",2020,"Results


rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment.","['stroke patients', '14 patients received', 'Stroke Patients', '34 PSCI patients for 20 sessions of 10 Hz rTMS or no-stim control treatments over the left dorsal lateral prefrontal cortex (DLPFC']","['rTMS intervention', 'functional MRI scan', 'rTMS', '\n\n\nRepetitive transcranial magnetic stimulation (rTMS']","['ALFF of the left medial prefrontal cortex, and increased FC of right medial prefrontal cortex and right ventral anterior cingulate cortex', 'cognitive functions and ADLs', 'Montreal Cognitive Assessment Scale, Victoria Stroop Test, Rivermead Behavior Memory Test, and Activities of Daily Living (ADL', 'cognitive function and quality of life', 'Cognitive function', 'amplitude of low-frequency fluctuation (ALFF) and functional connectivity (FC', 'Cognitive Impairment and Resting-State Brain Activity']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",34.0,0.0254229,"Results


rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment.","[{'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lingrong', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Ai', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiquan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Frontiers in neural circuits,['10.3389/fncir.2020.563777']
2037,33117138,Brain Vital Signs Detect Information Processing Differences When Neuromodulation Is Used During Cognitive Skills Training.,"Background : Neuromodulation through translingual neurostimulation (TLNS) has been shown to initiate long-lasting processes of neuronal reorganization with a variety of outcomes (i.e., neuroplasticity). Non-invasive TLNS is increasingly accessible through the Portable Neuromodulation Stimulator (PoNS ® ), a medical device that delivers electrical stimulation to the tongue to activate the trigeminal (V) and facial (VII) cranial nerves. Anecdotal reports from previous clinical studies have suggested incidental improvements in cognitive function. To objectively explore this observation, we examined TLNS-related effects on the semantic N400 brain vital sign cognitive response during cognitive skills training in healthy individuals.  Methods : Thirty-seven healthy volunteers were randomized to receive simultaneous TLNS (treatment) or no TLNS (control) while undergoing cognitive skills training. Cognitive training was conducted for two 20-min sessions (morning and afternoon/evening) over 3 consecutive days. Brain vital signs were evaluated at baseline, Day 1, and Day 3. Analyses focused on cognitive processing as measured by N400 changes in amplitude and latency.  Results : Over the 3-day course of cognitive training, the N400 amplitude decreased significantly in the control group due to habituation ( p  = 0.028). In contrast, there was no significant change in the TLNS treatment group.  Conclusion : TLNS led to a sustained N400 response during cognitive skills training, as measured by the brain's vital signs framework. The study findings suggest differential learning effects due to neuromodulation, consistent with increased attention and cognitive vigilance.",2020,"TLNS led to a sustained N400 response during cognitive skills training, as measured by the brain's vital signs framework.","['Methods : Thirty-seven healthy volunteers', 'healthy individuals']","['simultaneous TLNS (treatment) or no TLNS (control) while undergoing cognitive skills training', 'Cognitive training', 'translingual neurostimulation (TLNS', 'TLNS', 'cognitive skills training']","['cognitive processing', 'semantic N400 brain vital sign cognitive response', 'attention and cognitive vigilance', 'Brain vital signs', 'N400 amplitude']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0579088', 'cui_str': 'Cognitive skills training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",37.0,0.026246,"TLNS led to a sustained N400 response during cognitive skills training, as measured by the brain's vital signs framework.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Livingstone', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Shaun D', 'Initials': 'SD', 'LastName': 'Fickling', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Tannouri', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Natasha K J', 'Initials': 'NKJ', 'LastName': 'Campbell', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Bimal', 'Initials': 'B', 'LastName': 'Lakhani', 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Danilov', 'Affiliation': 'Pavlov Institute of Physiology, Russian Academy of Science, Saint Petersburg, Russia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Sackier', 'Affiliation': 'Helius Medical Technologies, Newtown, PA, United States.'}, {'ForeName': 'Ryan C N', 'Initials': 'RCN', 'LastName': ""D'Arcy"", 'Affiliation': 'Centre for Neurology Studies, HealthTech Connex, Metro-Vancouver, BC, Canada.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00358']
2038,33117187,"A Single 60.000 IU Dose of Erythropoietin Does Not Improve Short-Term Aerobic Exercise Performance in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial.","Erythropoietin (EPO) boosts exercise performance through increase in oxygen transport capacity following regular administration of EPO but preclinical study results suggest that single high dose of EPO also may improve exercise capacity. Twenty-nine healthy subjects (14 males/15 females; age: 25 ± 3 years) were included in a randomized, double-blind, placebo-controlled crossover study to assess peak work load and cardiopulmonary variables during submaximal and maximal cycling tests following a single dose of 60.000 IU of recombinant erythropoietin (EPO) or placebo (PLA). Submaximal exercise at 40%/60% of peak work load revealed no main effect of EPO on oxygen uptake (27.9 ± 8.7 ml min -1 ⋅kg -1 / 37.1 ± 13.2 ml min -1 ⋅kg -1 ) versus PLA (25.2 ± 3.7 ml min -1 ⋅kg -1 / 33.1 ± 5.3 ml min -1 ⋅kg -1 ) condition ( p  = 0.447/ p  = 0.756). During maximal exercise peak work load (PLA: 3.5 ± 0.6 W⋅kg -1  vs. EPO: 3.5 ± 0.6 W kg -1 ,  p  = 0.892) and peak oxygen uptake (PLA: 45.1 ± 10.4 ml⋅min -1  kg -1  vs. EPO: 46.1 ± 14.2 ml⋅min -1  kg -1 ,  p  = 0.344) reached comparable values in the two treatment conditions. Other cardiopulmonary variables (ventilation, cardiac output, heart rate) also reached similar levels in the two treatment conditions. An interaction effect was found between treatment condition and sex resulting in higher peak oxygen consumption ( p  = 0.048) and ventilation ( p  = 0.044) in EPO-treated males. In conclusion, in a carefully conducted study using placebo-controlled design the present data failed to support the hypothesis that a single high dose of EPO has a measurable impact on work capacity in healthy subjects.",2020,An interaction effect was found between treatment condition and sex resulting in higher peak oxygen consumption ( p  = 0.048) and ventilation ( p  = 0.044) in EPO-treated males.,"['Twenty-nine healthy subjects (14 males/15 females; age: 25 ± 3 years', 'healthy subjects', 'Healthy Subjects']","['recombinant erythropoietin (EPO) or placebo (PLA', 'Erythropoietin', 'EPO', 'placebo', 'Erythropoietin (EPO', 'Placebo']","['peak oxygen uptake', 'Short-Term Aerobic Exercise Performance', 'cardiopulmonary variables (ventilation, cardiac output, heart rate', 'peak oxygen consumption', 'oxygen uptake', 'exercise capacity']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",29.0,0.508638,An interaction effect was found between treatment condition and sex resulting in higher peak oxygen consumption ( p  = 0.048) and ventilation ( p  = 0.044) in EPO-treated males.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Haider', 'Affiliation': 'Institute for Veterinary Physiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'Institute for Veterinary Physiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Albert', 'Affiliation': 'Institute of Human Movement Science and Sport, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alvarez-Sanchez', 'Affiliation': 'Institute for Veterinary Physiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Thiersch', 'Affiliation': 'Institute for Veterinary Physiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Maggiorini', 'Affiliation': 'Institute of Intensive Care Medicine, University Hospital of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Matthias P', 'Initials': 'MP', 'LastName': 'Hilty', 'Affiliation': 'Institute of Intensive Care Medicine, University Hospital of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Spengler', 'Affiliation': 'Zurich Center for Integrative Human Physiology (ZIHP), Zurich, Switzerland.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Gassmann', 'Affiliation': 'Institute for Veterinary Physiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.'}]",Frontiers in physiology,['10.3389/fphys.2020.537389']
2039,33120862,"One-Year Effects of Omega-3 Treatment on Fatty Acids, Oxylipins, and Related Bioactive Lipids and Their Associations with Clinical Lipid and Inflammatory Biomarkers: Findings from a Substudy of the Vitamin D and Omega-3 Trial (VITAL).","Omega-3 (n-3) treatment may lower cardiovascular risk, yet its effects on the circulating lipidome and relation to cardiovascular risk biomarkers are unclear. We hypothesized that n-3 treatment is associated with favorable changes in downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers. We examined these VITAL200, a nested substudy of 200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL). VITAL is a randomized double-blind trial of 840 mg/d eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo among 25,871 individuals. Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells were measured using three independent assaying techniques at baseline and one year. The Women's Health Study (WHS) was used for replication with dietary n-3 intake. Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids. N-3 related changes in the bioactive lipidome were heterogeneously associated with changes in clinical lipid and inflammatory biomarkers. N-3 treatment significantly modulates the bioactive lipidome, which may contribute to its clinical benefits.",2020,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","['25,871 individuals', '200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL']","['n-3 treatment', 'Omega-3 Treatment', 'Omega-3 (n-3', 'N-3 treatment', 'eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo']","['downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers', 'Fatty Acids, Oxylipins, and Related Bioactive Lipids', '143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR', 'EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids', 'Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",,0.199205,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","[{'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Jeramie D', 'Initials': 'JD', 'LastName': 'Watrous', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lagerborg', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Dashti', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Giulianini', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Heath', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'OmegaQuant Analytics, Sioux Falls, SD 57106, USA.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Allen M', 'Initials': 'AM', 'LastName': 'Andres', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Tivari', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Long', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Mahan', 'Initials': 'M', 'LastName': 'Najhawan', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Khoi', 'Initials': 'K', 'LastName': 'Dao', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Ctr, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10110431']
2040,33120891,Multiple Cryotherapy Attenuates Oxi-Inflammatory Response Following Skeletal Muscle Injury.,"The oxi-inflammatory response is part of the natural process mobilizing leukocytes and satellite cells that contribute to clearance and regeneration of damaged muscle tissue. In sports medicine, a number of post-injury recovery strategies, such as whole-body cryotherapy (WBC), are used to improve skeletal muscle regeneration often without scientific evidence of their benefits. The study was designed to assess the impact of WBC on circulating mediators of skeletal muscle regeneration. Twenty elite athletes were randomized to WBC group (3-min exposure to -120 °C, twice a day for 7 days) and control group. Blood samples were collected before the first WBC session and 1 day after the last cryotherapy exposure. WBC did not affect the indirect markers of muscle damage but significantly reduced the generation of reactive oxygen and nitrogen species (H 2 O 2  and NO) as well as the concentrations of serum interleukin 1β (IL-1β) and C-reactive protein (CRP). The changes in circulating growth factors, hepatocyte growth factor (HGF), insulin-like growth factor (IGF-1), platelet-derived growth factor (PDGF BB ), vascular endothelial growth factor (VEGF), and brain-derived neurotrophic factor (BDNF), were also reduced by WBC exposure. The study demonstrated that WBC attenuates the cascade of injury-repair-regeneration of skeletal muscles whereby it may delay skeletal muscle regeneration.",2020,WBC did not affect the indirect markers of muscle damage but significantly reduced the generation of reactive oxygen and nitrogen species (H 2 O 2  and NO) as well as the concentrations of serum interleukin 1β (IL-1β) and C-reactive protein (CRP).,['Twenty elite athletes'],"['WBC', 'Multiple Cryotherapy']","['WBC', 'Blood samples', 'concentrations of serum interleukin 1β (IL-1β) and C-reactive protein (CRP', 'circulating growth factors, hepatocyte growth factor (HGF), insulin-like growth factor (IGF-1), platelet-derived growth factor (PDGF BB ), vascular endothelial growth factor (VEGF), and brain-derived neurotrophic factor (BDNF', 'generation of reactive oxygen and nitrogen species']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}, {'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]",20.0,0.0392382,WBC did not affect the indirect markers of muscle damage but significantly reduced the generation of reactive oxygen and nitrogen species (H 2 O 2  and NO) as well as the concentrations of serum interleukin 1β (IL-1β) and C-reactive protein (CRP).,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zembron-Lacny', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Morawin', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Wawrzyniak-Gramacka', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Gramacki', 'Affiliation': 'Centre of Information Technologies, University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Jarmuzek', 'Affiliation': 'Department of Nervous System Diseases, Collegium Medium University of Zielona Gora, Neurosurgery Center University Hospital in Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kotlega', 'Affiliation': 'Department of Neurology, Pomeranian Medical University Szczecin, 70-204 Szczecin, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Sport Kinesiology, Poznan University of Physical Education, 61-871 Poznan, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17217855']
2041,33121007,Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study.,"CAP7.1 is a novel topoisomerase II inhibitor, converted to active etoposide via carboxylesterase 2 (CES2), with signals of efficacy in treatment-refractory solid tumours. In a Phase II trial, 27 patients with advanced biliary tract cancers (BTC) were randomised 1:1 to CAP7.1 plus best supportive care (BSC), or BSC alone, with crossover to CAP7.1 upon disease progression. The primary objective was disease control rate (DCR) following 28-day cycles of CAP7.1 (200/150 mg/m 2 ; iv), or BSC until progression. Secondary objectives included progression-free survival (PFS), time-to-treatment failure (TTF), overall survival (OS) and safety. Fourteen patients received CAP7.1 and 13 BSC. DCR favoured CAP7.1 vs. BSC (50% vs. 20%; treatment difference: 30%, 95%CI -18.44, 69.22, full analysis set [FAS]), with disease progression in 40% vs. 70%, respectively. Significantly longer median PFS was achieved for CAP7.1 vs. BSC: 66 vs. 39 days, respectively (hazard ratio [HR] 0.31; 95%CI 0.11, 0.86;  p  = 0.009; FAS). Similar trends were observed for TTF and OS. CES2-positive patients had longer median PFS (158 vs. 56 days) and OS (228 vs. 82 days) vs. CES2-negative patients. Adverse events were predictable, dose-dependent and consistent with those previously observed with etoposide. These efficacy and safety findings in second-line BTC warrant further clinical investigation of CAP7.1.",2020,CES2-positive patients had longer median PFS (158 vs. 56 days) and OS (228 vs. 82 days) vs. CES2-negative patients.,"['27 patients with advanced biliary tract cancers (BTC', 'Advanced Biliary Tract Cancers']","['CAP7.1', 'CAP7.1 vs. BSC', 'CAP7.1 and 13 BSC', 'etoposide', 'CAP7.1 plus best supportive care (BSC), or BSC alone']","['TTF and OS', 'DCR favoured CAP7.1 vs. BSC', 'disease progression', 'longer median PFS', 'Adverse events', 'Efficacy and Safety', 'median PFS', 'disease control rate (DCR', 'progression-free survival (PFS), time-to-treatment failure (TTF), overall survival (OS) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",27.0,0.218312,CES2-positive patients had longer median PFS (158 vs. 56 days) and OS (228 vs. 82 days) vs. CES2-negative patients.,"[{'ForeName': 'Ulrich-Frank', 'Initials': 'UF', 'LastName': 'Pape', 'Affiliation': 'Department of Hepatology and Gastroenterology, Campus Charité Mitte and Virchow Klinikum, Charité Universitätsmedizin Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, 45147 Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Meiler', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, 45147 Essen, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Department of Medical Oncology, Universitäts Klinikum Hamburg-Eppendorf, 20251 Hamburg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Onkologische Schwerpunktpraxis Leer-Emden-Papenburg, 26789 Leer, Germany.'}, {'ForeName': 'Oswald', 'Initials': 'O', 'LastName': 'Burkhard', 'Affiliation': 'Onkologische Praxis, 67547 Worms, Germany.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Caca', 'Affiliation': 'Klinikum Ludwigsburg, 71640 Ludwigsburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Heeg', 'Affiliation': 'Department of Medicine II, Gastroenterology, Hepatology, Endocrinology and Infectious Diseases, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 70085 Freiburg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Büchner-Steudel', 'Affiliation': 'Martin-Luther-University Halle Wittenberg, Medizinische Fakultät, Universitätsklinik und Poliklinik für Innere Medizin I, 06120 Halle (Saale), Germany.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Rodriguez-Laval', 'Affiliation': 'Hospital Universitario de La Princesa, 28006 Madrid, Spain.'}, {'ForeName': 'Anja A', 'Initials': 'AA', 'LastName': 'Kühl', 'Affiliation': 'iPATH.Berlin, Core Unit of the Charité, Hindenburgdamm, 12203 Berlin, Germany.'}, {'ForeName': 'Ruza', 'Initials': 'R', 'LastName': 'Arsenic', 'Affiliation': 'Instituts für Histologische und Zytologische Diagnostik AG, 5000 Aarau, Switzerland.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Jansen', 'Affiliation': 'Institute for Medical Immunology, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Treasure', 'Affiliation': 'Peter Treasure Statistical Services Ltd., Stow Bridge PE34 3NR, UK.'}, {'ForeName': 'Nalân', 'Initials': 'N', 'LastName': 'Utku', 'Affiliation': 'Instituts für Histologische und Zytologische Diagnostik AG, 5000 Aarau, Switzerland.'}]",Cancers,['10.3390/cancers12113149']
2042,33121028,"Effects of S-PBL in Maternity Nursing Clinical Practicum on Learning Attitude, Metacognition, and Critical Thinking in Nursing Students: A Quasi-Experimental Design.","Due to the coronavirus disease (COVID-19) pandemic, there are many restrictions in effect in clinical nursing practice. Since effective educational strategies are required to enhance nursing students' competency in clinical practice, this study sought to evaluate the effectiveness of simulation problem-based learning (S-PBL). A quasi-experimental control group pretest-post-test design was used. Nursing students were allocated randomly to the control group ( n  = 31) and the experimental group ( n  = 47). Students in the control group participated in a traditional maternity clinical practicum for a week, while students in the experimental group participated S-PBL for a week. The students in the experimental group were trained in small groups using a childbirth patient simulator (Gaumard ®  Noelle ®  S554.100, Miami, USA) based on a standardized scenario related to obstetric care. The students' learning attitude, metacognition, and critical thinking were then measured via a self-reported questionnaire. Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p  < 0.01) in the experimental group. S-PBL was found to be an effective strategy for improving nursing students' learning transfer. Thus, S-PBL that reflects various clinical situations is recommended to improve the training in maternal health nursing.",2020,"Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p  < 0.01) in the experimental group.","['Nursing Students', 'Nursing students']","['traditional maternity clinical practicum', 'childbirth patient simulator (Gaumard ®  Noelle ®  S554.100, Miami, USA) based on a standardized scenario related to obstetric care', 'S-PBL']",['learning attitude and critical thinking'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]",,0.0150455,"Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p  < 0.01) in the experimental group.","[{'ForeName': 'Hae Kyoung', 'Initials': 'HK', 'LastName': 'Son', 'Affiliation': 'College of Nursing, Eulji University, Seongnam 13135, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17217866']
2043,33121228,Efficacy and safety of norepinephrine versus phenylephrine infusion for prophylaxis against spinal anesthesia-induced hypotension in elderly population undergoing hip fracture surgery: a randomized controlled trial.,"Background


The aim of this study was to compare the hemodynamic effects of prophylactic infusion of norepinephrine (NE) versus phenylephrine (PE) in elderly patients undergoing hip fracture surgery.
Methods


Elderly patients scheduled for hip fracture surgery were randomized to receive either NE infusion (8 mcg/min) (NE group, n=31) or PE infusion (100 mcg/min) (PE group, n=31) after spinal anesthesia. Outcomes include heart rate, mean blood pressure, cardiac output, incidence of spinal anesthesia-induced hypotension, incidence of bradycardia, and incidence of hypertension.
Results


Sixty-two patients with a mean age of 71±6 years were available for the final analysis (31 patients in each group). The NE group showed higher mean heart rate and cardiac output compared to the PE group. The NE group had a lower incidence of reactive bradycardia (10% vs. 36%, P=0.03) and hypertension (3% vs. 36%, P=0.003) than the PE group. None of our study patients developed hypotension, and the mean blood pressure was comparable between both groups.
Conclusions


Both NE and PE infusions effectively prevented spinal anesthesia-induced hypotension in elderly patients undergoing hip fracture surgery. However, NE provided more hemodynamic stability than PE, maintaining the heart rate, higher cardiac output, less reactive bradycardia, and hypertension.",2020,"The NE group had a lower incidence of reactive bradycardia (10% vs. 36%, P=0.03) and hypertension (3% vs. 36%, P=0.003) than the PE group.","['Elderly patients scheduled for hip fracture surgery', 'elderly patients undergoing hip fracture surgery', 'elderly population undergoing hip fracture surgery']","['norepinephrine', 'phenylephrine (PE', 'norepinephrine (NE', 'NE', 'NE infusion (8 mcg/min) (NE group, n=31) or PE infusion', 'NE and PE', 'phenylephrine infusion']","['hypotension', 'mean blood pressure', 'spinal anesthesia-induced hypotension', 'mean heart rate and cardiac output', 'reactive bradycardia', 'heart rate, mean blood pressure, cardiac output, incidence of spinal anesthesia-induced hypotension, incidence of bradycardia, and incidence of hypertension', 'hemodynamic stability', 'Efficacy and safety', 'heart rate, higher cardiac output, less reactive bradycardia, and hypertension', 'hypertension']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439424', 'cui_str': 'ug/min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085128', 'cui_str': 'Increased cardiac output'}]",62.0,0.103337,"The NE group had a lower incidence of reactive bradycardia (10% vs. 36%, P=0.03) and hypertension (3% vs. 36%, P=0.003) than the PE group.","[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mai Y', 'Initials': 'MY', 'LastName': 'Taha', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsayad', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Fatma Alzahraa', 'Initials': 'FA', 'LastName': 'Haggag', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Taalab', 'Affiliation': 'Department of Orthopedic Surgery, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Rady', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Bassant', 'Initials': 'B', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.20519']
2044,33121256,The Calming Effect of Maternal Breast Milk Odor on Term Infant: A Randomized Controlled Trial.,"Purpose:  This study was carried out to assess the effect of the odor of breast milk and formula milk on reducing the acute pain of newborn infants during the heel-prick blood sampling.  Methods:  Eighty-four newborn were randomly assigned into two groups (formula milk group and breast milk group) with 42 infant searches. The pain that the newborn felt before, during, and after heel-prick blood sampling was assessed using Neonatal Infant Pain Scale; their heart rate and blood oxygen saturation were measured with a pulse oximeter. Saliva samples were taken from newborns before and after sampling, and their salivary cortisol level was measured. During sampling, the crying duration of newborn was recorded with a chronometer.  Results:  The pain threshold and heart rates of the newborn in the breast milk group were significantly lower than those in the formula milk group ( p  < 0.001). Salivary cortisol in the formula milk group increased and oxygen saturation levels in these infants decreased significantly more as compared to the breast milk group ( p  < 0.05).  Conclusions:  The odor of breast milk may be helpful in reducing the pain of newborn during heel-prick blood sampling.",2020,The pain threshold and heart rates of the newborn in the breast milk group were significantly lower than those in the formula milk group ( p  < 0.001).,"['on Term Infant', 'Methods:  Eighty-four newborn', 'newborn infants during the heel-prick blood sampling']","['odor of breast milk and formula milk', 'formula milk group and breast milk group) with 42 infant searches', 'Maternal Breast Milk Odor']","['pain threshold and heart rates of the newborn', 'acute pain', 'oxygen saturation levels', 'Neonatal Infant Pain Scale; their heart rate and blood oxygen saturation', 'crying duration of newborn', 'Salivary cortisol', 'salivary cortisol level']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",84.0,0.0206312,The pain threshold and heart rates of the newborn in the breast milk group were significantly lower than those in the formula milk group ( p  < 0.001).,"[{'ForeName': 'Bircan', 'Initials': 'B', 'LastName': 'Taşçı', 'Affiliation': 'Department of Paediatric Nursing, Institute of Health Sciences, Bülent Ecevit University, Zonguldak, Turkey.'}, {'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Kuzlu Ayyıldız', 'Affiliation': 'Department of Paediatric Nursing, Institute of Health Sciences, Bülent Ecevit University, Zonguldak, Turkey.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0116']
2045,33121289,Effects of chronotherapy on circadian rhythm and ADHD symptoms in adults with attention-deficit/hyperactivity disorder and delayed sleep phase syndrome: a randomized clinical trial.,"The majority of adults with Attention-Deficit/Hyperactivity Disorder (ADHD) have a delayed circadian rhythm that is a characteristic of Delayed Sleep Phase Syndrome (DSPS). Treatment of DSPS may improve both the circadian rhythm and ADHD symptoms. In this three-armed randomized clinical trial, 51 adults (18-55 y) with ADHD and DSPS received sleep education and 3 weeks of (1) 0.5 mg/d placebo, (2) 0.5 mg/d melatonin, or (3) 0.5 mg/d melatonin plus 30 minutes of 10,000 lux bright light therapy (BLT) between 07:00 and 08:00 h. Placebo/melatonin conditions were double-blind. Treatment took place in the participants' naturalistic home settings. Dim-light melatonin onset (DLMO) was measured in saliva as marker of internal circadian rhythm. Melatonin or placebo administration followed individual schedules, starting 3 hours before the individual DLMO and weekly advancing by 1 h. DLMO and ADHD Rating Scale score were assessed at baseline, directly after 3-week treatment, and two weeks after the end of treatment. Results show that at baseline 77% had a DLMO after 21:00 h with an average DLMO at 23:43 h ± 1h46. Directly after treatment, melatonin had advanced DLMO by 1h28 ( p  = .001), and melatonin plus BLT by 1h58 ( p  < .001). Placebo did not affect DLMO. ADHD symptoms reduced by 14% ( p  = .038) directly after melatonin treatment. Placebo and melatonin plus BLT did not impact ADHD symptoms. Two weeks after end of treatment, ADHD symptoms and DLMO had returned to baseline levels. It can be concluded that low doses of melatonin advanced the circadian rhythm and reduced self-reported ADHD symptoms. Given the large number of adult ADHD patients with concurrent DSPS, treating delayed sleep with melatonin is an important component of effective ADHD treatment.",2020,"Directly after treatment, melatonin had advanced DLMO by 1h28 ( p  = .001), and melatonin plus BLT by 1h58 ( p  < .001).","[""participants' naturalistic home settings"", 'adults with attention-deficit/hyperactivity disorder and delayed sleep phase syndrome', 'adults with Attention-Deficit/Hyperactivity Disorder (ADHD', '51 adults (18-55\xa0y) with ADHD and DSPS received sleep education and 3\xa0weeks of (1) 0.5 mg/d']","['melatonin', 'DSPS', 'Melatonin or placebo', 'Dim-light melatonin onset (DLMO', 'chronotherapy', 'placebo, (2) 0.5 mg/d melatonin, or (3) 0.5 mg/d melatonin plus 30\xa0minutes of 10,000 lux bright light therapy (BLT) between 07:00 and 08:00\xa0h. Placebo/melatonin', 'Placebo and melatonin plus BLT', 'Placebo']","['Rating Scale score', 'ADHD symptoms', 'ADHD symptoms and DLMO', 'DLMO', 'advanced DLMO', 'circadian rhythm and ADHD symptoms']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0376626', 'cui_str': 'Chronotherapy'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]",51.0,0.467987,"Directly after treatment, melatonin had advanced DLMO by 1h28 ( p  = .001), and melatonin plus BLT by 1h58 ( p  < .001).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'van Andel', 'Affiliation': 'PsyQ, Expertise Center Adult ADHD , The Hague, The Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bijlenga', 'Affiliation': 'PsyQ, Expertise Center Adult ADHD , The Hague, The Netherlands.'}, {'ForeName': 'Suzan W N', 'Initials': 'SWN', 'LastName': 'Vogel', 'Affiliation': 'PsyQ, Expertise Center Adult ADHD , The Hague, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Center , Amsterdam, The Netherlands.'}, {'ForeName': 'J J Sandra', 'Initials': 'JJS', 'LastName': 'Kooij', 'Affiliation': 'PsyQ, Expertise Center Adult ADHD , The Hague, The Netherlands.'}]",Chronobiology international,['10.1080/07420528.2020.1835943']
2046,33121372,Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT.,"OBJECTIVES


The IMPACT trial has compared the benefit in the reduction of moderate/severe exacerbations of single inhaler triple therapy (SITT) with fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI)  versus  dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA) in the treatment of patients with chronic obstructive disease (COPD). This study performs a subgroup analysis of the cohort from Spain in the IMPACT study.
MATERIALS AND METHODS


In IMPACT, a 52-week randomized, double-blind, parallel-group, multicenter study ( N  = 10,355), patients ⩾40 years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Here, we present a subgroup analysis of the 499 patients from Spain, included in the intent-to-treat (ITT) population in the study. Endpoint assessed included exposure-adjusted rate of moderate and severe exacerbations.
RESULTS


In the Spain cohort, the exposure-adjusted rate of on-treatment moderate/severe COPD exacerbations per year for FF/UMEC/VI was 1.31  versus  1.43 and 1.57 for FF/VI and UMEC/VI, respectively. No new adverse events were identified. The results are consistent with those observed in the overall ITT study population.
CONCLUSION


In the Spain cohort of the IMPACT study, patients receiving triple therapy with FF/UMEC/VI had a lower exposure-adjusted rate of exacerbations compared with FF/VI and UMEC/VI, similar to the overall population. Study Title:  A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease URL : https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/ https://clinicaltrials.gov/ct2/show/NCT02164513 Registration number : GSK (CTT116855/NCT02164513). The reviews of this paper are available via the supplemental material section.",2020,No new adverse events were identified.,"['multicenter study ( N \u2009=\u200910,355), patients ⩾40\u2009years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year', 'patients with COPD', 'Subjects With Chronic Obstructive Pulmonary Disease URL ', 'patients with chronic obstructive disease (COPD', '499 patients from Spain, included in the intent-to-treat (ITT) population in the study']","['daily FF/UMEC/VI 100/62.5/25', 'FF/UMEC/VI compared with FF/VI and UMEC/VI', 'fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI)  versus  dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA']","['lower exposure-adjusted rate of exacerbations', 'severe COPD exacerbations', 'exposure-adjusted rate of moderate and severe exacerbations', 'Efficacy, Safety and Tolerability']","[{'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.763266,No new adverse events were identified.,"[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Marín', 'Affiliation': 'Servicio de Neumología, IISAragón, Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Mateos', 'Affiliation': 'Servicio de Neumología, Hospital de Mérida, Badajoz, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Roldán', 'Affiliation': 'Servicio de Neumología, Giromed Institute, Gerona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Echave-Sustaeta', 'Affiliation': 'Servicio de Neumología, Hospital Universitario Quirón Salud, Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Pascual-Guardia', 'Affiliation': 'Servicio de Neumología, Hospital del Mar-IMIM, CIBERES, UPF, BRN, Barcelona, Spain.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Pardo', 'Affiliation': 'Departamento Médico, España, GSK, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Velasco', 'Affiliation': 'Departamento Médico, España, GSK, Madrid, Spain.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, Collegeville, PA, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620963021']
2047,33121452,Effectiveness and safety of high dose clopidogrel plus aspirin in ischemic stroke patients with the single CYP2C19 loss-of-function allele: a randomized trial.,"BACKGROUND


Dual antiplatelet aggregation therapy leads to better outcomes in patients with carotid artery stenosis, intracranial artery stenosis, minor strokes, or transient ischaemic attacks. However, carriers of the CYP2C19 loss-of-function allele may not experience the desired effects. We attempted to increase the clopidogrel dose to determine whether it would improve the outcomes of stroke patients who carry a single loss-of-function allele.
METHODS


We recruited 131 patients with minor ischaemic stroke, within less than 7 days of stroke onset and a CYP2C19 loss-of-function allele, who had moderate-to-severe cerebral artery stenosis. Patients were divided into the high dose group (clopidogrel 150 mg per day + aspirin 100 mg per day over 21 days.) and a normal dose group (clopidogrel 75 mg per day + aspirin 100 mg per day over 21 days). The reported outcomes included any vascular or major bleeding events as the primary and safety endpoints, respectively.
RESULTS


One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively. However, no significant difference was found between the two groups when adjusted for history of diabetes (hazard ratio, 5482; 95% confidence interval, 0.660 to 45.543; P = 0.115). No major bleeding events occurred.
CONCLUSIONS


In patients with ischaemic stroke who had a single CYP2C19 loss-of-function allele and moderate to severe cerebral stenosis, fewer vascular events occurred within 3 months with high dose of clopidogrel and aspirin than with normal dose of clopidogrel and aspirin. However, the difference between the two groups was not significant.
TRIAL REGISTRATION


Clinical study of clopidogrel in the treatment of patients with symptomatic moderate to severe cerebral artery stenosis with intermediate metabolites of CYP2C19, URL: http://www.chictr.org.cn/ . Unique identifier: ChiCTR1800017411 , 07/28/2018.",2020,"One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively.","['ischemic stroke patients with the single CYP2C19 loss-of-function allele', 'patients with carotid artery stenosis, intracranial artery stenosis, minor strokes, or transient ischaemic attacks', '131 patients with minor ischaemic stroke, within less than 7\u2009days of stroke onset and a CYP2C19 loss-of-function allele, who had moderate-to-severe cerebral artery stenosis', 'patients with ischaemic stroke who had a single CYP2C19 loss-of-function allele and moderate to severe cerebral stenosis', 'patients with symptomatic moderate to severe cerebral artery stenosis with intermediate metabolites of CYP2C19, URL: http://www.chictr.org.cn/ ', 'stroke patients who carry a single loss-of-function allele']","['normal dose group (clopidogrel 75\u2009mg per day + aspirin', 'clopidogrel plus aspirin', 'clopidogrel 150\u2009mg per day + aspirin', 'clopidogrel', 'clopidogrel and aspirin']","['Effectiveness and safety', 'major bleeding events', 'vascular or major bleeding events', 'history of diabetes', 'vascular events']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0447028', 'cui_str': 'Structure of intracranial artery'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1504438', 'cui_str': 'Cerebral artery stenosis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",131.0,0.0693267,"One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively.","[{'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Huiqun', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Lianwei', 'Initials': 'L', 'LastName': 'Dou', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Ultrasound, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Lixiang', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Chuanyu', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Wenzheng', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China. chuwz2020@outlook.com.'}]",BMC neurology,['10.1186/s12883-020-01974-z']
2048,33121471,The efficacy of aspirin and metformin combination therapy in patients with rectal aberrant crypt foci: a double-blinded randomized controlled trial.,"BACKGROUND


The incidence and mortality rates of colorectal cancer (CRC) continue to increase worldwide. Therefore, new preventive strategies are needed to lower the burden of this disease. Previous studies reported that aspirin could suppress the development of sporadic colorectal adenoma. In addition, metformin is a biguanide derivative that is long widely used for the treatment of diabetes mellitus and has recently been suggested to have a suppressive effect on carcinogenesis and cancer cell growth. Both drugs exhibit a chemopreventive effect, but their efficacy is limited. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC. Thus, we designed a prospective trial as a preliminary study prior to a CRC chemoprevention trial to evaluate the chemopreventive effect of aspirin combined with metformin on colorectal ACF formation in patients scheduled for polypectomy.
METHODS


This study is a double-blind randomized controlled trial that will be conducted in patients with both colorectal ACF and colorectal polyps scheduled for polypectomy. Eligible patients will be recruited for the study and the number of ACF in the rectum will be counted at the baseline colonoscopy. Then, the participants will be allocated to one of the following two groups; the aspirin plus placebo group or the aspirin plus metformin group. Patients in the aspirin plus placebo group will receive oral aspirin (100 mg) and placebo for 8 weeks, and those in the aspirin plus metformin group will receive oral aspirin (100 mg) and metformin (250 mg) for 8 weeks. After 8 weeks of administration, polypectomy will be performed to evaluate changes in the number of ACF, and the cell-proliferative activity in the normal colorectal mucosa and colorectal polyps.
DISCUSSION


This is the first study proposed that will explore the effect of aspirin combined with metformin on the formation of colorectal ACF in humans.
TRIAL REGISTRATION


This trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000028259 . Registered 17 July 2017.",2020,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC.","['humans', 'patients with both colorectal ACF and colorectal polyps scheduled for polypectomy', 'patients with rectal aberrant crypt foci', 'Eligible patients will be recruited for the study and the number of ACF in the rectum will be counted at the baseline colonoscopy', 'patients scheduled for polypectomy', 'University Hospital Medical Information Network (UMIN']","['aspirin plus metformin', 'aspirin plus placebo', 'aspirin combined with metformin', 'oral aspirin', 'metformin', 'placebo', 'aspirin', 'aspirin and metformin combination therapy']","['colorectal ACF formation', 'sporadic colorectal adenoma', 'Aberrant crypt foci (ACF']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}]",,0.239173,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. takuma_h@yokohama-cu.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Arimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikari', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Takatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Misawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Fuyuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",BMC cancer,['10.1186/s12885-020-07564-z']
2049,33121474,Effects of propofol on intracranial pressure and prognosis in patients with severe brain diseases undergoing endotracheal suctioning.,"BACKGROUND


To investigate whether the administration of intravenous propofol before endotracheal suctioning (ES) in patients with severe brain disease can reduce the sputum suction response, improve prognosis, and accelerate recovery.
METHODS


A total of 208 severe brain disease patients after craniocerebral surgery were enrolled in the study. The subjects were randomly assigned to the experimental group (n = 104) and the control group (n = 104). The experimental group was given intravenous propofol (10 ml propofol with 1 ml 2% lidocaine), 0.5-1 mg/kg, before ES, while the control group was subjected to ES only. Changes in vital signs, sputum suction effect, the fluctuation range of intracranial pressure (ICP) before and after ES, choking cough response, short-term complications, length of stay, and hospitalization cost were evaluated. Additionally, the Glasgow Outcome Scale (GOS) prognosis score was obtained at 6 months after the operation.
RESULTS


At the baseline, the characteristics of the two groups were comparable (P > 0.05). The increase of systolic blood pressure after ES was higher in the control group than in the experimental group (P < 0.05). The average peak value of ICP in the experimental group during the suctioning (15.57 ± 12.31 mmHg) was lower than in the control group (18.24 ± 8.99 mmHg; P < 0.05). The percentage of patients experiencing cough reaction- during suctioning in the experimental group was lower than in the control group (P < 0.05), and the fluctuation range of ICP was increased (P < 0.0001). The effect of ES was achieved in both groups. The incidence of short-term complications in the two groups was comparable (P > 0.05). At 6 months after the surgery, the GOS scores were significantly higher in the experimental than in the control group (4-5 points, 51.54% vs. 32.64%; 1-3 points, 48.46% vs. 67.36%; P < 0.05). There was no significant difference in the length of stay and hospitalization cost between the two groups.
CONCLUSIONS


Propofol sedation before ES could reduce choking cough response and intracranial hypertension response. The use of propofol was safe and improved the long-term prognosis. The study was registered in the Chinese Clinical Trial Registry on May 16, 2015 (ChiCTR-IOR-15006441).",2020,The increase of systolic blood pressure after ES was higher in the control group than in the experimental group (P < 0.05).,"['patients with severe brain diseases undergoing endotracheal suctioning', 'patients with severe brain disease', '208 severe brain disease patients after craniocerebral surgery were enrolled in the study']","['ES', 'propofol', 'propofol before endotracheal suctioning (ES', 'propofol with 1\u2009ml 2% lidocaine', 'intravenous propofol']","['fluctuation range of ICP', 'GOS scores', 'Glasgow Outcome Scale (GOS) prognosis score', 'vital signs, sputum suction effect, the fluctuation range of intracranial pressure (ICP) before and after ES, choking cough response, short-term complications, length of stay, and hospitalization cost', 'intracranial pressure and prognosis', 'percentage of patients experiencing cough reaction', 'average peak value of ICP', 'incidence of short-term complications', 'choking cough response and intracranial hypertension response', 'systolic blood pressure after ES', 'length of stay and hospitalization cost']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006111', 'cui_str': 'Disorder of brain'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",208.0,0.0234251,The increase of systolic blood pressure after ES was higher in the control group than in the experimental group (P < 0.05).,"[{'ForeName': 'Menghang', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Maojun', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Pu', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Maojie', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, P. R. China. zerodq_hx@163.com.'}]",BMC neurology,['10.1186/s12883-020-01972-1']
2050,33121589,Flavor and Nicotine Effects on E-cigarette Appeal in Young Adults: Moderation by Reason for Vaping.,"Objectives:  Effective regulations that reduce nicotine vaping among young adult dual (combustible and e-cigarette) users may differ depending on whether e-cigarettes are used for helping with smoking cessation. This laboratory experiment examined flavor and nicotine effects on e-cigarette product appeal among young adult dual users, stratified by reported use of e-cigarettes to quit smoking.  Methods:  Dual users aged 18-35 years that did (N = 31) or did not (N = 22) report vaping for the purpose of quitting smoking puffed e-cigarette solutions varied by a flavor (fruit, menthol, tobacco) and nicotine (nicotine-containing [6 mg/mL], nicotine-free) with-in-participant design. After puffing each solution, participants rated appeal.  Results:  In main effect analyses, non-tobacco (vs tobacco) flavors increased appeal and nicotine-containing (vs nicotine free) solutions reduced appeal similarly in dual users who did and did not vape to quit smoking. Interaction analyses found non-significant trend evidence that fruit and menthol flavors suppressed nicotine's appeal-reducing effects more powerfully in those that did not vape to quit smoking (flavor × nicotine × vape to quit smoking, p s  = .05-.06).  Conclusions:  Non-tobacco flavors might increase e-cigarette product appeal in young adult dual users overall and disproportionately suppress nicotine's appeal-reducing effects in those that vape for purposes other than assisting with smoking cessation.",2020,Interaction analyses found non-significant trend evidence that fruit and menthol flavors suppressed nicotine's appeal-reducing effects more powerfully in those that did not vape to quit smoking (flavor × nicotine,"['Young Adults', 'young adult dual users', 'young adult dual (combustible and e-cigarette', 'Dual users aged 18-35 years that did (N = 31) or did not (N = 22) report vaping for the purpose of quitting smoking puffed e-cigarette solutions varied by a']","['flavor (fruit, menthol, tobacco) and nicotine (nicotine-containing [6 mg/mL], nicotine-free) with-in-participant design', 'nicotine-containing (vs nicotine free) solutions', 'nicotine', 'Flavor and Nicotine']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],,0.0175189,Interaction analyses found non-significant trend evidence that fruit and menthol flavors suppressed nicotine's appeal-reducing effects more powerfully in those that did not vape to quit smoking (flavor × nicotine,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, Department of Psychology, University of Southern California, Los Angeles, CA, Institute for Addiction Science, University of Southern California Keck School of Medicine, Los Angeles, CA;, Email: adam.leventhal@usc.edu.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Sam N', 'Initials': 'SN', 'LastName': 'Cwalina', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, Institute for Addiction Science, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whitted', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, Institute for Addiction Science, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, Institute for Addiction Science, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Callahan', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, Institute for Addiction Science, University of Southern California Keck School of Medicine, Los Angeles, CA, Department of Sociology, University of Southern California, Los Angeles, CA.'}]",American journal of health behavior,['10.5993/AJHB.44.5.15']
2051,33117195,The Acute Physiological Responses to Traditional vs. Practical Blood Flow Restriction Resistance Exercise in Untrained Men and Women.,"This study compared the acute physiological responses of traditional and practical blood flow restriction resistance exercise (tBFR and pBFR, respectively) and high- and low-load resistance exercise without BFR (HL and LL, respectively), as well as the potential sex differences within the aforementioned exercise methods. Fourteen men and fifteen women randomly completed the following experimental conditions: (1) tBFR, consisting of four sets of 30-15-15-15 repetitions of the bilateral horizontal leg press and knee extension exercises, at 30% of one-repetition maximum (1-RM), with a 13.5 cm wide pneumatic cuff placed at the most proximal portion of each thigh and inflated to a pressure equivalent to 50% of the participant's total occlusion pressure; (2) pBFR, which was the same as the tBFR condition, except that an elastic band wrapped around the proximal portion of each thigh at a tightness of 7 on a 0 to 10 perceived pressure scale was used to reduce blood flow; (3) LL, same as the tBFR and pBFR protocols, except that no BFR was applied; and (4) HL, consisting of 3 sets of 10 repetitions at 80% of 1-RM, with the same 1-min rest interval between sets and a 3-min rest period between exercises. At baseline, immediately post-, 5 min post-, and 15 min post-exercise, whole-blood lactate (WBL), indices of muscle swelling (muscle thickness and thigh circumference), hematocrit and plasma volume changes, were measured as well as superficial electromyography (sEMG) amplitude during exercise. There were no significant ( p  > 0.05) differences between the tBFR and pBFR exercise protocols for any of the physiological parameters assessed. However, significantly greater ( p  < 0.05) WBL and sEMG values were observed for HL compared to the remaining exercise conditions. Finally, males displayed greater WBL levels than females at 15 min post-exercise. Interestingly, males also displayed significantly ( p  < 0.05) greater sEMG amplitude than females within the low-load trials during leg press, but no significant ( p  < 0.05) sex differences were observed during knee extension. In conclusion, tBFR and pBFR seemed to be capable of inducing the same acute physiological responses. Furthermore, males displayed greater responses than females for some of the physiological parameters measured.",2020,There were no significant ( p  > 0.05) differences between the tBFR and pBFR exercise protocols for any of the physiological parameters assessed.,"['Untrained Men and Women', 'Fourteen men and fifteen women randomly completed the following experimental conditions: (1']","[""tBFR, consisting of four sets of 30-15-15-15 repetitions of the bilateral horizontal leg press and knee extension exercises, at 30% of one-repetition maximum (1-RM), with a 13.5 cm wide pneumatic cuff placed at the most proximal portion of each thigh and inflated to a pressure equivalent to 50% of the participant's total occlusion pressure; (2) pBFR"", 'traditional and practical blood flow restriction resistance exercise (tBFR and pBFR, respectively) and high- and low-load resistance exercise without BFR (HL and LL, respectively', 'Traditional vs. Practical Blood Flow Restriction Resistance Exercise']","['WBL levels', 'blood lactate (WBL), indices of muscle swelling (muscle thickness and thigh circumference), hematocrit and plasma volume changes, were measured as well as superficial electromyography (sEMG) amplitude during exercise', 'sEMG amplitude', 'WBL and sEMG values']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042950', 'cui_str': 'Volition'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0281913', 'cui_str': 'Swelling of skeletal muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",14.0,0.0342184,There were no significant ( p  > 0.05) differences between the tBFR and pBFR exercise protocols for any of the physiological parameters assessed.,"[{'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Bianca R A', 'Initials': 'BRA', 'LastName': 'Galletti', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Sensory and Muscle Function Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bemben', 'Affiliation': 'Bone Density Research Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Neuromuscular Laboratory, Department of Health and Exercise Science, The University of Oklahoma, Norman, OK, United States.'}]",Frontiers in physiology,['10.3389/fphys.2020.577224']
2052,33117217,Influence of Network Size on Adversarial Decisions in a Deception Game Involving Honeypots.,"Deception via honeypots, computers that pretend to be real, may provide effective ways of countering cyberattacks in computer networks. Although prior research has investigated the effectiveness of timing and amount of deception via deception-based games, it is unclear as to how the size of the network (i.e., the number of computer systems in the network) influences adversarial decisions. In this research, using a deception game (DG), we evaluate the influence of network size on adversary's cyberattack decisions. The DG has two sequential stages, probe and attack, and it is defined as DG (n,k, γ), where n is the number of servers, k is the number of honeypots, and γ is the number of probes that the adversary makes before attacking the network. In the probe stage, participants may probe a few web servers or may not probe the network. In the attack stage, participants may attack any one of the web servers or decide not to attack the network. In a laboratory experiment, participants were randomly assigned to a repeated DG across three different between-subject conditions: small (20 participants), medium (20 participants), and large (20 participants). The small, medium, and large conditions used DG (2, 1, 1), DG (6, 3, 3), and DG (12, 6, 6) games, respectively (thus, the proportion of honeypots was kept constant at 50% in all three conditions). Results revealed that in the small network, the proportions of honeypot and no-attack actions were 0.20 and 0.52, whereas in the medium (large) network, the proportions of honeypot and no-attack actions were 0.50 (0.50) and 0.06 (0.03), respectively. There was also an effect of probing actions on attack actions across all three network sizes. We highlight the implications of our results for networks of different sizes involving deception via honeypots.",2020,"Deception via honeypots, computers that pretend to be real, may provide effective ways of countering cyberattacks in computer networks.",[],[],"['proportions of honeypot and no-attack actions', 'attack actions']",[],[],"[{'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",,0.0422147,"Deception via honeypots, computers that pretend to be real, may provide effective ways of countering cyberattacks in computer networks.","[{'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Katakwar', 'Affiliation': 'Applied Cognitive Science Laboratory, Indian Institute of Technology Mandi, Kamand, India.'}, {'ForeName': 'Palvi', 'Initials': 'P', 'LastName': 'Aggarwal', 'Affiliation': 'Dynamic Decision Making Laboratory, Carnegie Mellon University, Pittsburgh, PA, United States.'}, {'ForeName': 'Zahid', 'Initials': 'Z', 'LastName': 'Maqbool', 'Affiliation': 'Applied Cognitive Science Laboratory, Indian Institute of Technology Mandi, Kamand, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dutt', 'Affiliation': 'Applied Cognitive Science Laboratory, Indian Institute of Technology Mandi, Kamand, India.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.535803']
2053,33117243,"Two Birds, One Stone: The Effectiveness of Health and Environmental Messages to Reduce Meat Consumption and Encourage Pro-environmental Behavioral Spillover.","There is a growing consensus that reducing excess meat consumption will be necessary to meet climate change targets, whilst also benefitting people's health. Strategies aimed at encouraging reduced meat consumption also have the potential to promote additional pro-environmental behaviors through behavioral spillover, which can be catalyzed through an increased pro-environmental identity. Based on this, the current study tested the effectiveness of a randomized two-week messaging intervention on reducing red and processed meat consumption and encouraging pro-environmental behavioral spillover. Participants were undergraduate students in the United Kingdom ( n  = 320 at baseline) randomly allocated to four conditions in which they received information about the health, environmental, or combined (health and environmental) impacts of meat consumption, and a no-message control. The results showed that receiving information on the health and/or environmental impacts of meat was effective in reducing red and processed meat consumption compared to the control group during the intervention period, with some effects remaining one-month later. However, the intervention did not have any effect on pro-environmental identity and there was little evidence of behavioral spillover. Implications for future research and interventions aimed at reducing meat consumption are discussed.",2020,"The results showed that receiving information on the health and/or environmental impacts of meat was effective in reducing red and processed meat consumption compared to the control group during the intervention period, with some effects remaining one-month later.","['Two Birds, One Stone', 'Participants were undergraduate students in the United Kingdom ( n  = 320 at baseline) randomly allocated to four conditions in which they received']","['information about the health, environmental, or combined (health and environmental) impacts of meat consumption, and a no-message control']",['red and processed meat consumption'],"[{'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.023925,"The results showed that receiving information on the health and/or environmental impacts of meat was effective in reducing red and processed meat consumption compared to the control group during the intervention period, with some effects remaining one-month later.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wolstenholme', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Poortinga', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Whitmarsh', 'Affiliation': 'Department of Psychology, University of Bath, Bath, United Kingdom.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.577111']
2054,33117255,Cerebral Perfusion Effects of Cognitive Training and Transcranial Direct Current Stimulation in Mild-Moderate TBI.,"Background:  Persistent post-traumatic symptoms (PPS) after traumatic brain injury (TBI) can lead to significant chronic functional impairment. Pseudocontinuous arterial spin labeling (pCASL) has been used in multiple studies to explore changes in cerebral blood flow (CBF) that may result in acute and chronic TBI, and is a promising neuroimaging modality for assessing response to therapies.  Methods:  Twenty-four subjects with chronic mild-moderate TBI (mmTBI) were enrolled in a pilot study of 10 days of computerized executive function training combined with active or sham anodal transcranial direct current stimulation (tDCS) for treatment of cognitive PPS. Behavioral surveys, neuropsychological testing, and magnetic resonance imaging (MRI) with pCASL sequences to assess global and regional CBF were obtained before and after the training protocol.  Results:  Robust improvements in depression, anxiety, complex attention, and executive function were seen in both active and sham groups between the baseline and post-treatment visits. Global CBF decreased over time, with differences in regional CBF noted in the right inferior frontal gyrus (IFG). Active stimulation was associated with static or increased CBF in the right IFG, whereas sham was associated with reduced CBF. Neuropsychological performance and behavioral symptoms were not associated with changes in CBF.  Discussion:  The current study suggests a complex picture between mmTBI, cerebral perfusion, and recovery. Changes in CBF may result from physiologic effect of the intervention, compensatory neural mechanisms, or confounding factors. Limitations include a small sample size and heterogenous injury sample, but these findings suggest promising directions for future studies of cognitive training paradigms in mmTBI.",2020,"Robust improvements in depression, anxiety, complex attention, and executive function were seen in both active and sham groups between the baseline and post-treatment visits.","['Methods:  Twenty-four subjects with chronic mild-moderate TBI (mmTBI', 'Mild-Moderate TBI']","['Pseudocontinuous arterial spin labeling (pCASL', 'computerized executive function training combined with active or sham anodal transcranial direct current stimulation (tDCS', 'magnetic resonance imaging (MRI) with pCASL sequences', 'Cognitive Training and Transcranial Direct Current Stimulation']","['static or increased CBF', 'depression, anxiety, complex attention, and executive function', 'cerebral blood flow (CBF', 'Global CBF', 'global and regional CBF', 'Neuropsychological performance and behavioral symptoms', 'regional CBF']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",24.0,0.142923,"Robust improvements in depression, anxiety, complex attention, and executive function were seen in both active and sham groups between the baseline and post-treatment visits.","[{'ForeName': 'Davin K', 'Initials': 'DK', 'LastName': 'Quinn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Upston', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Brandt', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Story-Remer', 'Affiliation': 'Chicago Medical School, Chicago, IL, United States.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Fratzke', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Wilson', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rieger', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hunter', 'Affiliation': 'Naval Health Research Center, San Diego, CA, United States.'}, {'ForeName': 'Darbi', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Richardson', 'Affiliation': 'Department of Speech and Hearing Sciences, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Clark', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Yeo', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Claude William', 'Initials': 'CW', 'LastName': 'Shuttleworth', 'Affiliation': 'Department of Neuroscience, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, Albuquerque, NM, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.545174']
2055,33117260,"Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study.","Introduction:  Novel therapies are needed for the treatment of motion sickness given the inadequate relief and bothersome and dangerous adverse effects of currently approved therapies. Neurokinin-1 (NK1) receptor antagonists have the potential to be effective in improving the symptoms of motion sickness, given the involvement of Substance P in nauseogenic and emetic pathways and the expression of NK1 receptors in the gastrointestinal system. Here we evaluated the efficacy of tradipitant, a novel NK1 receptor antagonist, in preventing motion sickness in variable sea conditions.  Methods:  A total of 126 adults participated in the Motion Sifnos study. Groups of participants were assigned to one of seven boat trips lasting ~4 h on the Pacific Ocean. Participants were randomized 1:1 to tradipitant 170 mg or placebo and completed the Motion Sickness Severity Scale (MSSS) every 30 min, in addition to other assessments. Severity of motion sickness was assessed with the incidence of vomiting and the MSSS.  Results:  Participants on tradipitant had a significantly lower incidence of vomiting as compared to those on placebo across all boat trips (tradipitant = 17.5%, placebo = 39.7%,  p  = 0.0039). For trips exposed to rough sea conditions, the difference in the incidence of vomiting between the groups was more dramatic (tradipitant = 15.79%, placebo = 72.22%,  p  = 0.0009). Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant = 3.19, placebo = 4.57,  p  = 0.0235).  Discussion:  Tradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.",2020,"Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant = 3.19, placebo = 4.57,  p  = 0.0235).  ","['Results:  Participants on tradipitant', 'people with motion sickness', 'Motion Sickness', '126 adults participated in the Motion Sifnos study']","['tradipitant 170 mg or placebo', 'placebo', 'Neurokinin-1 (NK1) receptor antagonists', 'Placebo']","['vomiting', 'motion sickness symptoms', 'Severity of motion sickness', 'incidence of vomiting', 'Motion Sickness Severity Scale (MSSS']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3543440', 'cui_str': 'Neurokinin 1 receptor antagonist'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",126.0,0.0984883,"Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant = 3.19, placebo = 4.57,  p  = 0.0235).  ","[{'ForeName': 'Vasilios M', 'Initials': 'VM', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Mark É', 'Initials': 'MÉ', 'LastName': 'Czeisler', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Gibson', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Austin A', 'Initials': 'AA', 'LastName': 'Anderson', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Miglo', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Christos M', 'Initials': 'CM', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Birznieks', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}, {'ForeName': 'Mihael H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals, Washington, DC, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.563373']
2056,33117558,Randomised feasibility trial and embedded qualitative process evaluation of a new intervention to facilitate the involvement of older patients with multimorbidity in decision-making about their healthcare during general practice consultations: the VOLITION study protocol.,"Background


The number of older people with multiple health problems is increasing worldwide. This creates a strain on clinicians and the health service when delivering clinical care to this patient group, who themselves carry a large treatment burden. Despite shared decision-making being acknowledged by healthcare organisations as a priority feature of clinical care, older patients with multimorbidity are less often involved in decision-making when compared with younger patients, with some evidence suggesting associated health inequalities. Interventions aimed at facilitating shared decision-making between doctors and patients are outdated in their assessments of today's older patient population who need support in prioritising complex care needs in order to maximise quality of life and day-to-day function.
Aims


To undertake feasibility testing of an intervention ('VOLITION') aimed at facilitating the involvement of older patients with more than one long-term health problem in shared decision-making about their healthcare during GP consultations.To inform the design of a fully powered trial to assess intervention effectiveness.
Methods


This study is a cluster randomised controlled feasibility trial with qualitative process evaluation interviews. Participants are patients, aged 65 years and above with more than one long-term health problem (multimorbidity), and the GPs that they consult with. This study aims to recruit 6 GP practices, 18 GPs and 180 patients. The intervention comprises two components: (i) a half-day training workshop for GPs in shared decision-making; and (ii) a leaflet for patients that facilitate their engagement with shared decision-making. Intervention implementation will take 2 weeks (to complete delivery of both patient and GP components), and follow-up duration will be 12 weeks (from index consultation and commencement of data collection to final case note review and process evaluation interview). The trial will run from 01/01/20 to 31/01/21; 1 year 31 days.
Discussion


Shared decision-making for older people with multimorbidity in general practice is under-researched. Emerging clinical guidelines advise a patient-centred approach, to reduce treatment burden and focus on quality of life alongside disease control. The systematic development, testing and evaluation of an intervention is warranted and timely. This study will test the feasibility of implementing a new intervention in UK general practice for future evaluation as a part of routine care.
Trial registration


CLINICAL TRIALS.GOV registration number NCT03786315, registered 24/12/18.",2020,"Aims


To undertake feasibility testing of an intervention ('VOLITION') aimed at facilitating the involvement of older patients with more than one long-term health problem in shared decision-making about their healthcare during GP consultations.","['older people with multiple health problems', 'Participants are patients, aged 65 years and above with more than one long-term health problem (multimorbidity), and the GPs that they consult with', 'older patients with more than one long-term health problem in shared decision-making about their healthcare during GP consultations', 'recruit 6 GP practices, 18 GPs and 180 patients', 'older people with multimorbidity in general practice', 'older patients with multimorbidity in decision-making about their healthcare during general practice consultations']",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]",[],[],,0.135055,"Aims


To undertake feasibility testing of an intervention ('VOLITION') aimed at facilitating the involvement of older patients with more than one long-term health problem in shared decision-making about their healthcare during GP consultations.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Butterworth', 'Affiliation': ""Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, Room 110, Smeall building, St Luke's campus, Magdalen Road, Exeter, EX1 2LU UK.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Warren', 'Affiliation': ""Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, Room 110, Smeall building, St Luke's campus, Magdalen Road, Exeter, EX1 2LU UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Pitchforth', 'Affiliation': ""Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, Room 110, Smeall building, St Luke's campus, Magdalen Road, Exeter, EX1 2LU UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': ""Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, Room 110, Smeall building, St Luke's campus, Magdalen Road, Exeter, EX1 2LU UK.""}]",Pilot and feasibility studies,['10.1186/s40814-020-00699-7']
2057,33117559,A feasibility pragmatic clinical trial of a primary care network exercise and education program for people with COPD.,"Background


Pulmonary rehabilitation is an important component of chronic disease management in chronic obstructive pulmonary disease (COPD) and has been shown to improve shortness of breath, exercise capacity, quality of life, and decrease hospitalizations. However, pulmonary rehabilitation capacity is low. Primary care may be an effective method for delivering disease management services to this population. The objective of this feasibility pragmatic clinical trial was to evaluate enrollment and completion of a primary care network exercise and education program for people with COPD.
Methods


COPD patients ( N  = 23; mean age = 65 ± 9 years; FEV1 = 68 ± 20% predicted) were recruited after referral to a primary care network exercise program in Edmonton, Alberta. Participants self-selected either an 8-week 16-session supervised exercise program or an 8-week unsupervised exercise program where they received three visits with an exercise specialist. Both groups self-selected education sessions with clinicians for disease management support. Referrals, completion, and program outcomes (physical activity, exercise capacity and health status) were measured before (T1), immediately after (T2), and 8 weeks following the program (T3).
Results


Forty-three referrals were received in 10 months, where a minimum of 50 was required in order for the program to be considered feasible. Twenty-three participants provided baseline data, and twenty participants started the exercise program (10 in each exercise group), 16 of which completed the exercise program (80%). On average, 48% of the recommended education sessions were completed by participants.
Conclusions


Enrollment into a COPD exercise and education program in a primary care network was low indicating the need for improved referral processes from physicians. Completion rates by participants were adequate for exercise but not education. The low referral rate and the lack of enrollment in COPD education by the patients indicate that a large-scale trial of the program as designed is not feasible.",2020,"Referrals, completion, and program outcomes (physical activity, exercise capacity and health status) were measured before (T1), immediately after (T2), and 8 weeks following the program (T3).
","['chronic obstructive pulmonary disease (COPD', 'Participants self-selected either an', 'people with COPD', 'Methods\n\n\nCOPD patients ( N  = 23; mean age = 65 ± 9\u2009years; FEV1 = 68 ± 20% predicted) were recruited after referral to a primary care network exercise program in Edmonton, Alberta']","['8-week 16-session supervised exercise program or an 8-week unsupervised exercise program where they received three visits with an exercise specialist', '\n\n\nPulmonary rehabilitation', 'exercise program', 'COPD exercise and education program', 'primary care network exercise and education program']","['shortness of breath, exercise capacity, quality of life', 'Referrals, completion, and program outcomes (physical activity, exercise capacity and health status', 'low referral rate']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",43.0,0.065326,"Referrals, completion, and program outcomes (physical activity, exercise capacity and health status) were measured before (T1), immediately after (T2), and 8 weeks following the program (T3).
","[{'ForeName': 'Kelsey M T', 'Initials': 'KMT', 'LastName': 'Hurley', 'Affiliation': 'Faculty of Kinesiology Sport and Recreation, University of Alberta, Edmonton, AB Canada.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Selzler', 'Affiliation': 'West Park Healthcare Centre, Toronto, ON Canada.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Rodgers', 'Affiliation': 'Faculty of Kinesiology Sport and Recreation, University of Alberta, Edmonton, AB Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'G.F. MacDonald Centre for Lung Health Covenant Health, Edmonton, AB Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00705-y']
2058,33117673,Clinical Significance of Glucose to Lymphocyte Ratio (GLR) as a Prognostic Marker for Patients With Pancreatic Cancer.,"Glucose metabolism and systemic inflammation have been associated with cancer aggressiveness and patient prognosis in various malignancies. This study aimed to evaluate the prognostic significance of pretreatment GLR(glucose to lymphocyte ratio) and systemic immune inflammation in patients with pancreatic cancer. We studied 360 patients with pathologically diagnosed pancreatic adenocarcinoma that was clinically unresectable. Baseline clinicopathological characteristics and laboratory investigations including fasting blood glucose, platelet count, lymphocyte count, neutrophil count, carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA199), and follow-up data were collected for further analysis. The patients were randomly divided into a training cohort ( n  = 238) and a validation cohort ( n  = 122). Univariate and multivariate Cox proportional hazard regression analyses were performed to identify the prognostic value of GLR, systemic immune-inflammation markers, and tumor biomarkers. A nomogram model was developed based on the identified prognostic factors, and we used the C-index to evaluate the accuracy of the Cox regression model prediction. Multivariate analysis revealed that GLR [hazard ratio (HR): 2.597; 95% confidence interval (CI): 1.728-3.904)] and CA199 (HR: 2.484; 95% CI: 1.295-4.765) are independent predictors of poor overall survival in the training cohort and were incorporated into the nomogram for OS as independent factors. Moreover, the C-index analyses demonstrated that the C-indexes in the training cohort and the validation cohort were 0.674 and 0.671, respectively. The nomogram model predicts overall survival relatively accurately. We found that the baseline GLR is an independent prognostic factor for patients with pancreatic cancer, and the proposed nomogram can be used as an effective tool for predicting the outcomes of prognosis of patients with pancreatic cancer.",2020,Multivariate analysis revealed that GLR [hazard ratio (HR): 2.597; 95% confidence interval (CI): 1.728-3.904)] and CA199 (HR: 2.484; 95% CI: 1.295-4.765) are independent predictors of poor overall survival in the training cohort and were incorporated into the nomogram for OS as independent factors.,"['Patients With Pancreatic Cancer', '360 patients with pathologically diagnosed pancreatic adenocarcinoma that was clinically unresectable', 'patients with pancreatic cancer']",[],"['fasting blood glucose, platelet count, lymphocyte count, neutrophil count, carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA199), and follow-up data', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]",[],"[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",360.0,0.0236098,Multivariate analysis revealed that GLR [hazard ratio (HR): 2.597; 95% confidence interval (CI): 1.728-3.904)] and CA199 (HR: 2.484; 95% CI: 1.295-4.765) are independent predictors of poor overall survival in the training cohort and were incorporated into the nomogram for OS as independent factors.,"[{'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Zhong', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Chien-Shan', 'Initials': 'CS', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Renquan', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Cancer Center, Fudan University, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.520330']
2059,33117716,Comprehensive Analysis of Prognostic Markers for Acute Myeloid Leukemia Based on Four Metabolic Genes.,"Background:  Metabolic reprogramming is the core characteristic of tumors during the development of tumors, and cancer cells can rely on metabolic changes to support their rapid growth. Nevertheless, an overall analysis of metabolic markers in acute myeloid leukemia (AML) is absent and urgently needed.  Methods:  Within this work, genetic expression, mutation data and clinical data of AML were queried from Genotype-Tissue Expression (GTEx) database, The Cancer Genome Atlas (TCGA) database and Gene Expression Omnibus (GEO) database. The tumor samples of TCGA were randomly divided into a training group (64 samples) and an internal validation group (64 samples) at one time, and the tumor samples of GEO served as two external validation groups (99 samples, 374 samples). According to the expression levels of survival-associated metabolic genes, we divided all TCGA tumor samples into high, medium and low metabolism groups, and evaluated the immune cell activity in the tumor microenvironment of the three metabolism groups by single-sample gene set enrichment analysis (ssGSEA) algorithm. Finally, we examined the mutations and prognostic effects of each model gene.  Results:  Four metabolism-related genes were screened and applied to construct a prognostic model for AML, giving excellent results. As for the area under the curve (AUC) value of receiver operating characteristic (ROC) curve, the training group was up to 0.902 (1-year), 0.81 (3-year), and 0.877 (5-year); and the internal and external validation groups also met the expected standards, showing high potency in predicting patient outcome. Univariate and multivariate prognostic analyses indicated that the riskScore obtained from our prognostic model was an independent prognostic factor. ssGSEA analysis revealed the high metabolism group had higher immune activity. Single and multiple gene survival analysis validated that each model gene had significant effects on the overall survival of AML patients.  Conclusions:  In our study, a high-efficiency prognostic prediction model was built and validated for AML patients. The results showed that metabolism-related genes could become potential prognostic biomarkers for AML.",2020,"As for the area under the curve (AUC) value of receiver operating characteristic (ROC) curve, the training group was up to 0.902 (1-year), 0.81 (3-year), and 0.877 (5-year); and the internal and external validation groups also met the expected standards, showing high potency in predicting patient outcome.","['acute myeloid leukemia (AML', 'Acute Myeloid Leukemia']",[],"['immune activity', 'area under the curve (AUC) value of receiver operating characteristic (ROC) curve', 'overall survival']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0189277,"As for the area under the curve (AUC) value of receiver operating characteristic (ROC) curve, the training group was up to 0.902 (1-year), 0.81 (3-year), and 0.877 (5-year); and the internal and external validation groups also met the expected standards, showing high potency in predicting patient outcome.","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Tongji Medical College, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shengling', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.578933']
2060,33117961,Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study.,"Background:  Neurogenic lower urinary tract dysfunction (NLUTD) is common among people with multiple sclerosis (MS) with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive option to manage bladder storage symptoms; however, the potential efficacy of TTNS among people with MS is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS.  Methods:  We will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in MS. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland's communication channels; 2) recruitment from a convenience sample of people with MS who have previously participated in a qualitative interview study of urinary symptoms. We will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life pre and post intervention using ICIQ-OAB, 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events. Acceptability of using TTNS will be evaluated at the end of intervention. This study has been reviewed and approved by the Education and Health Science's Faculty Research Ethics Committee, University of Limerick [2020_06_07_EHS].   Conclusion:  It is anticipated that assessing the feasibility and acceptability of TTNS for storage bladder symptoms in MS will inform the development of a definitive randomised trial.  Trial registration : ClinicalTrials.gov NCT04528784 27/08/2020.",2020,This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS.  ,"['people with multiple sclerosis (MS', 'people with MS', 'bladder storage symptoms in MS', ""people with MS through MS Ireland's communication channels; 2) recruitment from a convenience sample of people with MS who have previously participated in a qualitative interview study of urinary symptoms"", 'people with multiple sclerosis']","['Transcutaneous tibial nerve stimulation', 'TTNS', 'Transcutaneous tibial nerve stimulation (TTNS']","['bladder storage symptoms', ""ICIQ-OAB, 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143345,This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS.  ,"[{'ForeName': 'Hawra B', 'Initials': 'HB', 'LastName': 'Al Dandan', 'Affiliation': 'School of Allied Health, Faculty of Education and Health Sciences, Clinical therapies, University of Limerick, Limerick, County Limerick, Ireland.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Galvin', 'Affiliation': 'School of Allied Health, Faculty of Education and Health Sciences, Clinical therapies, University of Limerick, Limerick, County Limerick, Ireland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Robinson', 'Affiliation': 'School of Allied Health, Faculty of Education and Health Sciences, Clinical therapies, University of Limerick, Limerick, County Limerick, Ireland.'}, {'ForeName': 'Dorren', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Coote', 'Affiliation': 'School of Allied Health, Faculty of Education and Health Sciences, Clinical therapies, University of Limerick, Limerick, County Limerick, Ireland.'}]",HRB open research,['10.12688/hrbopenres.13107.1']
2061,33118052,Rapid and sustained decreases in suicidality following a single dose of ayahuasca among individuals with recurrent major depressive disorder: results from an open-label trial.,"RATIONALE


Suicidality is a major public health concern with limited treatment options. Accordingly, there is a need for innovative interventions for suicidality. Preliminary evidence indicates that treatment with the psychedelic ayahuasca may lead to decreases in depressive symptoms among individuals with major depressive disorder (MDD). However, there remains limited understanding of whether ayahuasca also leads to reductions in suicidality.
OBJECTIVE


To examine the acute and post-acute effect of ayahuasca on suicidality among individuals with MDD.
METHODS


We conducted a secondary analysis of an open-label trial in which individuals with recurrent MDD received a single dose of ayahuasca (N = 17). Suicidality was assessed at baseline; during the intervention; and 1, 7, 14, and 21 days after the intervention.
RESULTS


Among individuals with suicidality at baseline (n = 15), there were significant acute (i.e., 40, 80, 140, and 180 min after administration) and post-acute (1, 7, 14, and 21 days after administration) decreases in suicidality following administration of ayahuasca. Post-acute effect sizes for decreases in suicidality were large (Hedges' g = 1.31-1.75), with the largest effect size 21 days after the intervention (g = 1.75).
CONCLUSIONS


When administered in the appropriate context, ayahuasca may lead to rapid and sustained reductions in suicidality among individuals with MDD. Randomized, double-blind studies with larger sample sizes are needed to confirm this early finding.",2020,"Post-acute effect sizes for decreases in suicidality were large (Hedges' g = 1.31-1.75), with the largest effect size 21 days after the intervention (g = 1.75).
","['individuals with MDD', 'individuals with suicidality at baseline (n\u2009=\u200915', 'individuals with recurrent MDD received a single dose of ayahuasca (N\u2009=\u200917', 'individuals with recurrent major depressive disorder', 'individuals with major depressive disorder (MDD']","['ayahuasca', 'psychedelic ayahuasca']","['suicidality', 'Suicidality', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.352833,"Post-acute effect sizes for decreases in suicidality were large (Hedges' g = 1.31-1.75), with the largest effect size 21 days after the intervention (g = 1.75).
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Zeifman', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, Canada. rzeifman@ryerson.ca.'}, {'ForeName': 'Nikhita', 'Initials': 'N', 'LastName': 'Singhal', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Rafael G', 'Initials': 'RG', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Sanches', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'de Lima Osório', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Jaime E C', 'Initials': 'JEC', 'LastName': 'Hallak', 'Affiliation': 'Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05692-9']
2062,33118053,Correction to: Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'. NREM Weibull scale 1/ʎ, and Wake Weibull scale 1/ʎ.",2020,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'.",['people with insomnia and healthy controls'],['placebo-controlled pharmacological intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0141234,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'.","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05675-w']
2063,33118055,Assessing the effect of nicotine dose in cigarette smoking on sleep quality.,"BACKGROUND


While several studies assessed the relation between cigarette smoking and sleep, there are still very few studies assessing the effect of nicotine in cigarette smoking on sleep.
AIM


This study aimed to compare higher vs lower nicotine levels in cigarette smoking on sleep quality.
METHODS


We used data from the recently released dataset for the Randomized Trial of Reduced-Nicotine Standards for Cigarettes. We included three groups in the current study: the least nicotine concentration (i.e., 0.4 mg/g), a moderate nicotine concentration (i.e., 5.2 mg/g), and the highest nicotine concentration (i.e., 15.8 mg/g). For each participant, we included data regarding baseline and the last follow up at 6 weeks, where we compared insomnia, sleep problems, and awakening at night, in addition to different depression and affect scores.
RESULTS


A total of 360 patients were included in this study, with a mean age of 42.4 (±13.4) years. For the three nicotine groups (i.e., 0.4 mg/g, 5.2 mg/g, and 15.8 mg/g), we included 119 (33%), 122 (34%), and 119 (33%) participants. Among the high-nicotine-dose group, the number of participants who had worsened sleep was significantly higher than the number of those who had improved sleep (p = 0.01) after 6 weeks of consumption, where 37 (31%) had worsened sleep score after 6 weeks while only 19 (16%) had improved score compared with baseline.
CONCLUSION


While previous studies established a relation either between cigarette smoking and sleep or between nicotine patches and sleep, the present study is the first to establish that higher nicotine doses in cigarettes were associated with more sleep disturbances.",2020,"Among the high-nicotine-dose group, the number of participants who had worsened sleep was significantly higher than the number of those who had improved sleep (p = 0.01) after 6 weeks of consumption, where 37 (31%) had worsened sleep score after 6 weeks while only 19 (16%) had improved score compared with baseline.
CONCLUSION


","['A total of 360 patients were included in this study, with a mean age of 42.4 (±13.4) years']",['nicotine'],"['worsened sleep score', 'sleep quality', 'worsened sleep']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",360.0,0.0201658,"Among the high-nicotine-dose group, the number of participants who had worsened sleep was significantly higher than the number of those who had improved sleep (p = 0.01) after 6 weeks of consumption, where 37 (31%) had worsened sleep score after 6 weeks while only 19 (16%) had improved score compared with baseline.
CONCLUSION


","[{'ForeName': 'Saif Aldeen', 'Initials': 'SA', 'LastName': 'AlRyalat', 'Affiliation': 'Department of Special Surgery, The University of Jordan, Amman, 11942, Jordan. s.alryalat@ju.edu.jo.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kussad', 'Affiliation': 'Department of Pediatrics, The University of Jordan, Amman, 11942, Jordan.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'El Khatib', 'Affiliation': 'Department of Internal Medicine, The University of Jordan, Amman, 11942, Jordan.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Hamad', 'Affiliation': 'Hashemite University, Amman, Jordan.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Tanjy', 'Affiliation': 'The University of Jordan, Amman, 11942, Jordan.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alshnneikat', 'Affiliation': 'The University of Jordan, Amman, 11942, Jordan.'}, {'ForeName': 'Basma', 'Initials': 'B', 'LastName': 'AbuMahfouz', 'Affiliation': 'The University of Jordan, Amman, 11942, Jordan.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02238-3']
2064,33118102,The role of ICSI vs. conventional IVF for patients with advanced maternal age-a randomized controlled trial.,"OBJECTIVES


This study aimed to evaluate the role of intracytoplasmic sperm injection (ICSI) in the treatment of non-male factor infertile patients aged ≥ 39.
METHODS


This is a single-center, prospective, randomized controlled clinical trial, between March 2018 and December 2019. Sixty-nine patients were recruited, and sixty patients participated in the study. Their ovaries were randomized prior to the beginning of the ovarian stimulation: the oocytes from one side (n = 257) were allocated to the ICSI (ICSI arm), while those of the contralateral side (n = 258) were allocated to conventional insemination (IVF arm). The fertilization rate per oocyte retrieved, number of zygotes (2PN), and cleavage-stage embryos were assessed and compared between the two study groups.
RESULTS


The average number of zygotes (3.1 vs. 2.7 p = 0.45), the fertilization rate (72.4% vs. 65.1% p = 0.38), the average number of cleavage-stage (2.8 vs. 2.4 p = 0.29), and the average top-quality embryos (TQE) cleavage-stage embryos (1.7 vs. 1.6 p = 0.94) were comparable between the two groups. The TQE rate per randomized oocyte (41.2% vs. 41% p = 0.8) was also similar in both groups.
CONCLUSIONS


ICSI does not improve the reproductive outcomes of advanced-age patients undergoing conventional insemination for non-male factor infertility.
TRIAL REGISTRATION


NCT03370068.",2020,"CONCLUSIONS


ICSI does not improve the reproductive outcomes of advanced-age patients undergoing conventional insemination for non-male factor infertility.
","['patients with advanced maternal age', 'non-male factor infertile patients aged ≥\u200939', 'advanced-age patients undergoing', 'Sixty-nine patients were recruited, and sixty patients participated in the study']","['ICSI vs. conventional IVF', 'conventional insemination', 'intracytoplasmic sperm injection (ICSI', 'ICSI']","['average number of zygotes', 'average number of cleavage-stage', 'reproductive outcomes', 'fertilization rate per oocyte retrieved, number of zygotes (2PN), and cleavage-stage embryos', 'TQE rate per randomized oocyte', 'average top-quality embryos (TQE) cleavage-stage embryos', 'fertilization rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",69.0,0.237845,"CONCLUSIONS


ICSI does not improve the reproductive outcomes of advanced-age patients undergoing conventional insemination for non-male factor infertility.
","[{'ForeName': 'Jigal', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel. jigalh@hotmail.com.'}, {'ForeName': 'Tal Elkan', 'Initials': 'TE', 'LastName': 'Miller', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Ravit', 'Initials': 'R', 'LastName': 'Nahum', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Aizer', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kirshenbaum', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Zilberberg', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Oshrit', 'Initials': 'O', 'LastName': 'Lebovitz', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, 52620, Tel-Hashomer, Israel.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01990-5']
2065,33124016,Effects of Custom-made Mouthguards on Cardiopulmonary Exercise Capacity.,"The importance of using mouthguards as well as their low acceptance rate have been demonstrated. The aim of this study was to investigate the influence of customized mouthguards on hemodynamics.. This randomized crossover study used data from 13 subjects (23.5±1.4 years). The cardiopulmonary and metabolic parameters were observed during ergometer tests without mouthguard (control) in comparison to two types of mouthguards (with and normal without breathing channels). Maximum ventilation was significantly decreased with the normal mouthguard (113.3±30.00 l ∙ min -1 ) in contrast to the mouthguard with breathing channels (122.5±22.9 l ∙ min -1 ) and control (121.9±30.8 l ∙ min -1 ). Also the inspiration time was longer when using the normal mouthguard (0.70±0.11 s) compared to the mouthguard with breathing channels (0.63±0.11 s) and control (Co 0.64±0.10 s). Lactate was also increased under the influence of the mouthguard with breathing channels (10.72±1.4 mmol ∙ l -1 ) compared to the control (9.40±1.77 mmol ∙ l -1 ) and the normal mouthguard (9.02±1.67 mmol ∙ l -1 ). In addition, stroke volume kinetics (p=0.048) and maximum heart rates (p=0.01) show changes. Despite equal levels of oxygen uptake and performances under all three conditions, the use of mouthguards showed differences in cardiopulmonary parameters. The use of mouthguards during exercise does not affect physical performance and can be recommended for injury prevention.",2020,Maximum ventilation was significantly decreased with the normal mouthguard (113.3±30.00 l ∙ min -1 ) in contrast to the mouthguard with breathing channels (122.5±22.9 l ,['13 subjects (23.5±1.4 years'],['Custom-made Mouthguards'],"['maximum heart rates', 'stroke volume kinetics', 'Cardiopulmonary Exercise Capacity', 'Lactate', 'Maximum ventilation', 'inspiration time']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3880278', 'cui_str': 'Mouthguard, custom-made'}]","[{'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1384388', 'cui_str': 'Maximum breathing capacity'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}]",13.0,0.0243318,Maximum ventilation was significantly decreased with the normal mouthguard (113.3±30.00 l ∙ min -1 ) in contrast to the mouthguard with breathing channels (122.5±22.9 l ,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lässing', 'Affiliation': 'Institute of Sports Medicine & Prevention, University of Leipzig Faculty of Medicine, Leipzig, Germany.'}, {'ForeName': 'Antina', 'Initials': 'A', 'LastName': 'Schulze', 'Affiliation': 'Institute of Sports Medicine & Prevention, University of Leipzig Faculty of Medicine, Leipzig, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kwast', 'Affiliation': 'Institute of Sports Medicine & Prevention, University of Leipzig Faculty of Medicine, Leipzig, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Prävention, Universitat Leipzig, Leipzig, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Vondran', 'Affiliation': 'Department of Cardiovascular Surgery, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schröter', 'Affiliation': 'University Department for Cardiac Surgery Leipzig, Leipzig Heart Centre University Hospital Clinic for Cardiology, Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Institute of Sports Medicine & Prevention, University of Leipzig Faculty of Medicine, Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institute of Sports Medicine & Prevention, University of Leipzig Faculty of Medicine, Leipzig, Germany.'}]",International journal of sports medicine,['10.1055/a-1236-3814']
2066,33124098,"Three-dimensional assessment of accelerating orthodontic tooth movement - micro-osteoperforations versus piezocision: A randomized, parallel group and split-mouth controlled clinical trial.","OBJECTIVE


To compare the effects of micro-osteoperforations (MOPs) versus piezocision (Piezo) in accelerating orthodontic tooth movement in adults.
SETTING AND SAMPLE POPULATION


In this randomized, single-blinded, parallel-group, split-mouth clinical trial, 24 patients aged 15-40 years were recruited.
SUBJECTS AND METHODS


Patients were randomly allocated into two groups: MOPs and Piezo groups. One side of the maxilla was allocated randomly for treatment with one of these techniques, and the other side was treated conventionally to act as a split-mouth control. The rate of canine retraction was evaluated up to 3 months by three-dimensional digital models using a conventional labial appliance. Root resorption and bone height were evaluated using cone beam computed tomography.
RESULTS


The MOPs and Piezo groups showed a significantly higher rate of tooth movement after 3 months on the experimental sides than the control sides. However, the net movements in the MOPs and Piezo groups did not reveal a higher rate of tooth movement. Similarly, the overall net movement was -0.32 ± 1.14 mm and 0.55 ± 0.89 mm for MOPs and Piezo, respectively (P = 0.606). Regarding root resorption, the overall changes in intra- or intergroup comparisons were insignificant. Decreased canine palatal bone height was reported on the experimental side of the Piezo group (P = 0.015) after 3 months, but the overall changes were insignificant.
CONCLUSIONS


The effect of MOPs and Piezo techniques in accelerating the orthodontic canine retraction was comparable to each other, and to the conventional methods. Neither technique caused root resorption or increased vertical bone loss.",2020,"Decreased canine palatal bone height was reported on the experimental side of the Piezo group (P = 0.015) after 3 months, but the overall changes were insignificant.
","['adults', 'Patients', '24 patients aged 15-40 years were recruited']","['MOPs and Piezo', 'micro-osteoperforations (MOPs) versus piezocision (Piezo', 'MOPs and Piezo techniques', 'piezocision']","['orthodontic canine retraction', 'rate of tooth movement', 'overall net movement', 'Root resorption and bone height', 'root resorption or increased vertical bone loss', 'canine palatal bone height', 'rate of canine retraction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]",24.0,0.100159,"Decreased canine palatal bone height was reported on the experimental side of the Piezo group (P = 0.015) after 3 months, but the overall changes were insignificant.
","[{'ForeName': 'Basema', 'Initials': 'B', 'LastName': 'Alqadasi', 'Affiliation': 'Hospital of stomatology, Xian Jiao Tong University, China.'}, {'ForeName': 'Hou Yu', 'Initials': 'HY', 'LastName': 'Xia', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Hospital of stomatology, Xian Jiao Tong University, China.'}, {'ForeName': 'Maged Sultan', 'Initials': 'MS', 'LastName': 'Alhammadi', 'Affiliation': 'Division of Orthodontics and Dentofacial Orthopedics, Department of Preventive Dental Sciences, Faculty of Dentistry, Jazan University, Jazan, Saudi Arabia. (2nd affiliation) Assistant professor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dentistry, Ibb University, Republic of Yemen.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Hasan', 'Affiliation': 'College of Dentistry, Sanaa University, Sanaa, Republic of Yemen.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aldhorae', 'Affiliation': 'Orthodontic Department, College of Dentistry, Thamar University, Thamar, Republic of Yemen.'}, {'ForeName': 'Esam', 'Initials': 'E', 'LastName': 'Halboub', 'Affiliation': 'Department of Maxillofacial Surgery and Diagnostic Sciences, Faculty of Dentistry, Jazan University, Jazan, Saudi Arabia.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12437']
2067,33124122,Associations between objective afternoon and evening physical activity and objective sleep in patients with fibromyalgia and insomnia.,"Patients with fibromyalgia (FM) suffer from chronic pain, which limits physical activity and is associated with disturbed sleep. However, the relationship between physical activity, pain and sleep is unclear in these patients. This study examined whether actigraphic (Actiwatch-2, Philips Respironics) afternoon and evening activity and pain are associated with actigraphic sleep. Adults with FM and insomnia complaints (n = 160, mean age [M age  ] = 52, SD = 12, 94% female) completed 14 days of actigraphy. Activity levels (i.e., activity counts per minute) were recorded, and average afternoon/evening activity for intervals 12:00-3:00 PM, 3:00-6:00 PM and 6:00-9:00 PM was computed. Multiple linear regressions examined whether afternoon/evening activity, pain (daily evening diaries from 0 [no pain sensation] to 100 [most intense pain imaginable]), or their interaction, predicted sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time (TST) and sleep efficiency (SE). Greater afternoon activity was independently associated with lower SE (B = -0.08, p < .001), lower TST (β = -0.36, standard error [SE] = 0.06, p < .001) and longer WASO (B = 0.34, p < .001). Greater early evening activity was independently associated with lower SE (B = -0.06, p < .001), lower TST (β = -0.26, SE = 0.06, p < .001) and longer WASO (B = 0.23, p < .001). Self-reported pain intensity interacted with afternoon and early evening physical activity, such that associations between higher activity and lower SE were stronger for individuals reporting higher pain. Late evening activity was not associated with sleep outcomes. Results suggest that in FM, increased afternoon and early evening physical activity is associated with sleep disturbance, and this relationship is stronger in individuals with higher pain.",2020,"Greater afternoon activity was independently associated with lower SE (B = -0.08, p < .001), lower TST (β = -0.36, standard error [SE] = 0.06, p < .001) and longer WASO (B = 0.34, p < .001).","['M age  ]\xa0=\xa052, SD\xa0=\xa012, 94% female) completed 14\xa0days of actigraphy', 'Adults with FM and insomnia complaints (n\xa0=\xa0160, mean age ', 'patients with fibromyalgia and insomnia', 'Patients with fibromyalgia (FM) suffer from chronic pain', 'individuals with higher pain']",[],"['Greater afternoon activity', 'afternoon/evening activity, pain (daily evening diaries', 'longer WASO', 'Greater early evening activity', 'objective afternoon and evening physical activity and objective sleep', 'pain intensity', 'pain imaginable]), or their interaction, predicted sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time (TST) and sleep efficiency (SE', 'Late evening activity', 'Activity levels (i.e., activity counts per minute', 'afternoon and early evening physical activity', 'physical activity, pain and sleep', 'no pain sensation', 'actigraphic (Actiwatch-2, Philips Respironics) afternoon and evening activity and pain']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0311137,"Greater afternoon activity was independently associated with lower SE (B = -0.08, p < .001), lower TST (β = -0.36, standard error [SE] = 0.06, p < .001) and longer WASO (B = 0.34, p < .001).","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'McGovney', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}]",Journal of sleep research,['10.1111/jsr.13220']
2068,33124144,"Long-term clinical, virological and immunological outcomes following planned treatment interruption in HIV-infected children.","OBJECTIVES


Planned treatment interruption (PTI) of antiretroviral therapy (ART) in adults is associated with adverse outcomes. The PENTA 11 trial randomized HIV-infected children to continuous ART (CT) vs. CD4-driven PTIs. We report 5 years' follow-up after the end of main trial.
METHODS


Post-trial, all children resumed ART. Clinical, immunological, virological and treatment data were collected annually. A sub-study investigated more detailed immunophenotype. CT and PTI arms were compared using intention-to-treat. Laboratory parameters were compared using linear regression, adjusting for baseline values; mixed models were used to include all data over time.
RESULTS


In all, 101 children (51 CT, 50 PTI) contributed a median of 7.6 years, including 5.1 years of post-trial follow-up. Post-trial, there were no deaths, one pulmonary tuberculosis and no other CDC stage B/C events. At 5 years post-trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA < 50 copies/mL (P = 0.26). A persistent increase in CD8 cells was observed in the PTI arm. The sub-study (54 children) suggested that both naïve and memory populations contributed to higher CD8 cells following PTI. Mean CD4/CD8 ratios at 5 years post-trial were 1.22 and 1.08 in CT and PTI arms, respectively [difference (CT - PTI) = -0.15; 95% CI: -0.34-0.05), P = 0.14]. The sub-study also suggested that during the trial and at early timepoints after the end of the trial, reduction in CD4 in the PTI arm was mainly from loss of CD4 memory cells.
CONCLUSIONS


Children tolerated PTI with few long-term clinical, virological or immunological consequences.",2020,"At 5 years post-trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA < 50 copies/mL (P = 0.26).","['101 children (51 CT, 50 PTI) contributed a median of 7.6\xa0years, including 5.1\xa0years of post-trial follow-up', 'HIV-infected children']","['continuous ART (CT) vs. CD4-driven PTIs', 'Planned treatment interruption (PTI) of antiretroviral therapy (ART']","['Mean CD4/CD8 ratios', 'CD8 cells']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0391072', 'cui_str': 'platinum (bis(acetato))(ethylenediamine) diiodide'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",101.0,0.279726,"At 5 years post-trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA < 50 copies/mL (P = 0.26).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freguja', 'Affiliation': 'Section of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bamford', 'Affiliation': 'Department of Paediatric Infectious Diseases, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zanchetta', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Del Bianco', 'Affiliation': 'Clinical Trials and Biostatistic Unit, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Giaquinto', 'Affiliation': 'Department of Mother and Child Health, University of Padova, Padova, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'MRC Clinical Trials Unit, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dalzini', 'Affiliation': 'Section of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Compagnucci', 'Affiliation': 'INSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saidi', 'Affiliation': 'INSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Riault', 'Affiliation': 'INSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'MRC Clinical Trials Unit, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'Department of Paediatric Infectious Diseases, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Rossi', 'Affiliation': 'Section of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV medicine,['10.1111/hiv.12986']
2069,33121886,"A cluster quasi-randomized controlled trial of an interactive, monthly obstetric anesthesiology curriculum: impact on resident satisfaction and knowledge retention.","BACKGROUND


Increasingly, evidence supports the use of educational paradigms that focus on teacher-learner interaction and learner engagement. We redesigned our monthly obstetric anesthesia resident didactics from a lecture-based curriculum to an interactive format including problem-based learning, case discussion, question/answer sessions, and simulation. We hypothesized that the new curriculum would improve resident satisfaction with the educational experience, satisfaction with the rotation, and knowledge retention.
METHODS


Fifty-three anesthesiology residents were prospectively recruited and quasi-randomized through an alternating-month pattern to attend either interactive sessions or traditional lectures. Residents completed a daily satisfaction survey about quality of teaching sessions and a comprehensive satisfaction survey at the conclusion of the rotation. Knowledge retention was assessed with a knowledge test completed on the final day. The primary outcome was daily satisfaction with the curriculum, and secondary outcomes included overall satisfaction with the curriculum, overall rotation satisfaction, and within-resident difference between pre- and post-knowledge test scores.
RESULTS


No differences were observed in daily resident satisfaction after interactive sessions vs. traditional lectures. Furthermore, no differences were observed between the interactive sessions and traditional lecture groups in overall satisfaction with the curriculum, overall satisfaction with the entire rotation or within-resident difference between pre- and post-knowledge test scores.
CONCLUSIONS


Our study failed to demonstrate improvement in resident satisfaction or knowledge retention following implementation of an interactive curriculum on a month-long obstetric anesthesia rotation. Reasons may include misalignment of the intervention with measured study outcomes, lack of sensitivity of the survey tools, and inadequate training of faculty presenters.",2020,"Furthermore, no differences were observed between the interactive sessions and traditional lecture groups in overall satisfaction with the curriculum, overall satisfaction with the entire rotation or within-resident difference between pre- and post-knowledge test scores.
",['Fifty-three anesthesiology residents'],['interactive sessions or traditional lectures'],"['daily satisfaction', 'overall satisfaction with the curriculum, overall rotation satisfaction, and within-resident difference between pre- and post-knowledge test scores', 'overall satisfaction with the curriculum, overall satisfaction with the entire rotation or within-resident difference between pre- and post-knowledge test scores', 'daily resident satisfaction', 'Knowledge retention']","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0604493,"Furthermore, no differences were observed between the interactive sessions and traditional lecture groups in overall satisfaction with the curriculum, overall satisfaction with the entire rotation or within-resident difference between pre- and post-knowledge test scores.
","[{'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Ende', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: holly.ende@vumc.org.""}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Lumbreras-Marquez', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Farber', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Tsen', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2020.09.001']
2070,33121891,Preliminary Results of a Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation Versus Accelerated Partial Breast Irradiation (HYPAB Trial).,"BACKGROUND


The purpose of this study was to report preliminary data of a randomized phase III trial comparing hypofractionated whole breast irradiation (HWBI) and accelerated partial breast irradiation (APBI) using volumetric modulated arc therapy (VMAT).
MATERIAL AND METHODS


The HYPAB trial enrolled postmenopausal women with biopsy-proven infiltrating breast cancer, clinically negative axilla, single T1 to T2 tumors, who were treated with breast-conserving surgery. Patients were randomized 1:1 after surgery to HWBI (40.5 Gy whole breast, 48.0 Gy to surgical bed, 15 fractions over 3 weeks) or APBI (30 Gy delivered in 5 fractions of 6 Gy given on alternate days on the surgical bed). Cosmetic outcome was the primary end point of the study.
RESULTS


A total of 172 patients were enrolled. After a median follow-up of 36 months, 5 local failures and 3 locoregional failures were recorded, with no difference between the 2 treatment arms. Use of HWBI as compared with APBI was significantly correlated with increased incidence of overall (62% vs. 14%; P < .001) and grade 2 (18% vs. 1%; P < .001) acute skin toxicity. APBI was correlated with a lower incidence of overall late toxicity as compared with HWBI (18% vs. 41%; P = .001), but no significant difference was found in term of occurrence of grade 2 events (1% vs. 4%; P = NS). At comparative assessment between baseline and post-radiotherapy evaluation, impairment in cosmetic outcome was reported in 19 (11%) patients. Owing to premature closure of the study, no per-protocol comparison between the treatment arms was performed.
CONCLUSION


APBI with the VMAT technique is safe and feasible, with lower acute toxicity when compared with HWBI.",2020,"APBI was correlated with a lower incidence of overall late toxicity as compared with HWBI (18% vs. 41%; P = .001), but no significant difference was found in term of occurrence of grade 2 events (1% vs. 4%; P = NS).","['The HYPAB trial enrolled postmenopausal women with biopsy-proven infiltrating breast cancer, clinically negative axilla, single T1 to T2 tumors, who were treated with breast-conserving surgery', '172 patients were enrolled', 'Postmenopausal Women With Early Stage Breast Cancer']","['hypofractionated whole breast irradiation (HWBI) and accelerated partial breast irradiation (APBI) using volumetric modulated arc therapy (VMAT', 'VMAT technique', 'APBI', 'Hypofractionated Whole Breast Irradiation Versus Accelerated Partial Breast Irradiation', 'HWBI']","['overall late toxicity', 'Cosmetic outcome', 'local failures and 3 locoregional failures', 'acute skin toxicity', 'acute toxicity', 'APBI', 'cosmetic outcome']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}]",172.0,0.156675,"APBI was correlated with a lower incidence of overall late toxicity as compared with HWBI (18% vs. 41%; P = .001), but no significant difference was found in term of occurrence of grade 2 events (1% vs. 4%; P = NS).","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Franceschini', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy. Electronic address: davide.franceschini@humanitas.it.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Loi', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Chiola', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Arculeo', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marzo', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Bethania', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': 'Pathology Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masci', 'Affiliation': 'Medical Oncology Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Torrisi', 'Affiliation': 'Medical Oncology Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tinterri', 'Affiliation': 'Breast Surgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Breast Surgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Medical Oncology Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy; Humanitas University, Department of Biomedical Sciences, Milan, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Scorsetti', 'Affiliation': 'Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy; Humanitas University, Department of Biomedical Sciences, Milan, Italy.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.09.004']
2071,33121939,"Re: Nizar M. Tannir, Sabina Signoretti, Toni K. Choueiri, et al. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clin Cancer Res. In press. https://doi.org/10.1158/1078-0432.ccr-20-2063.",,2020,,['Patients with Advanced Sarcomatoid Renal Cell Carcinoma'],['Nivolumab Plus Ipilimumab'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1266043', 'cui_str': 'Renal cell carcinoma, sarcomatoid'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0202491,,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2020.10.005']
2072,33121980,Obstructive Sleep Apnea patients adhering to Continuous positive Airway Pressure: A randomized trial.,"BACKGROUND


Excessive daytime sleepiness (EDS) in individuals with obstructive sleep apnea syndrome persisting despite good adherence to continuous positive airway pressure (CPAP) is a disabling condition. Pitolisant is a selective histamine H3-receptor antagonist with wake-promoting effects.
RESEARCH QUESTION


Is pitolisant efficacious and safe in reducing daytime sleepiness in individuals presenting moderate to severe OSA adhering to CPAP treatment but having residual EDS?
STUDY DESIGN AND METHODS


In a multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/day and taken over 12 weeks. The primary endpoint was change in the Epworth Sleepiness Scale (ESS) score in intention to treat. Key secondary endpoints were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test (OSleR), clinical global impressions of severity, the patient's global opinion, EQ-5D quality-of-life, Pichot Fatigue questionnaire scores and safety.
RESULTS


244 OSA participants (82.8% male; mean age: 53.1 years, mean apnea+hypopnea index under CPAP: 4.2/hour, baseline ESS score: 14.7, were randomized to pitolisant (n=183) or placebo (n=61). ESS significantly decreased with pitolisant compared to placebo -2.6 (95%CI: [-3.9;-1.4]) (p<0.001) and the rate of responders to therapy (ESS≤10 or ΔESS≥3) was significantly higher with pitolisant (71.0% vs 54.1%; p=0.013). Adverse event occurrence (mainly headache and insomnia) was higher in the pitolisant group compared to the placebo group (47.0% and 32.8%, p=0.03). No cardiovascular or other significant safety concerns were reported.
INTERPRETATION


Pitolisant used as adjunct to CPAP therapy for OSA with residual sleepiness despite good CPAP adherence significantly reduces subjective and objective sleepiness and improves participant-reported outcomes and physician-reported disease severity.",2020,ESS significantly decreased with pitolisant compared to placebo -2.6,"['Obstructive Sleep Apnea patients adhering to Continuous positive Airway Pressure', 'individuals with obstructive sleep apnea syndrome', '244 OSA participants (82.8% male; mean age: 53.1 years, mean apnea+hypopnea index under CPAP: 4.2/hour, baseline ESS score: 14.7, were randomized to pitolisant (n=183) or', 'individuals presenting moderate to severe OSA adhering to CPAP treatment but having residual EDS']","['placebo', 'continuous positive airway pressure (CPAP']","['daytime sleepiness', 'Adverse event occurrence (mainly headache and insomnia', 'ESS', ""maintenance of wakefulness assessed by the Oxford Sleep Resistance Test (OSleR), clinical global impressions of severity, the patient's global opinion, EQ-5D quality-of-life, Pichot Fatigue questionnaire scores and safety"", 'Epworth Sleepiness Scale (ESS) score', 'rate of responders to therapy (ESS≤10 or ΔESS≥3']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",244.0,0.29983,ESS significantly decreased with pitolisant compared to placebo -2.6,"[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'HP2 laboratory, INSERM U1042, University Grenoble Alpes; and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France. Electronic address: JPepin@chu-grenoble.fr.'}, {'ForeName': 'Ognian', 'Initials': 'O', 'LastName': 'Georgiev', 'Affiliation': 'Alexandrovska Hospital Medical University, Department of Internal Medicine, Pulmonology, Sofia, Bulgaria.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Tiholov', 'Affiliation': 'Department of Internal Diseases, Sv. Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Attali', 'Affiliation': 'Neurophysiologie Respiratoire Expérimentale et Clinique UMRS1158, Sorbonne Université, INSERM; and Service des Pathologies du Sommeil (Departement R3S, DMU APPROCHES), Groupe Hospitalier Universitaire APHP-Sorbonne Université, Paris, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'Universitair Multidisciplinair Slaap Centrum, Edegem-Antwerp, Belgium.'}, {'ForeName': 'Bertien', 'Initials': 'B', 'LastName': 'Buyse', 'Affiliation': 'Leuvens Universitair Centrum voor Slaap-en waakstoornissen, Department of Respiratory Diseases, University Hospitals Leuven and KU Leuven, Belgium.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Helsinki Sleep Clinic, Vitalmed Research Center, Department of Clinical Neurosciences, University of Helsinki, Finland.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Interdisziplinares Schlafmedizinisches Zentrum, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Belev', 'Affiliation': 'Pulmonology, Department of Internal Medicine, St George Hospital Medical University, Plovdiv, Bulgaria.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Dokic', 'Affiliation': 'Department of Pulmology and Allergy, Mother Teresa Medical University, Macedonia.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'HP2 laboratory, INSERM U1042, University Grenoble Alpes; and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lévy', 'Affiliation': 'HP2 laboratory, INSERM U1042, University Grenoble Alpes; and EFCR Laboratory, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Centre National de Référence Narcolepsie, Unité du Sommeil, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Université de Montpellier, INSERM U1061, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.09.281']
2073,33121984,Bleaching toothpaste with two different concentrations of hydrogen peroxide: A randomized double-blinded clinical trial.,"OBJECTIVES


This randomized double-blinded clinical trial evaluated the bleaching efficacy and incidence of contact hypersensitivity of three kinds of bleaching toothpaste.
METHODS


Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13) were randomized into three groups: TW group (n = 15), 0.75% HP-containing toothpaste (Toothwhole white); VL group (n = 15), 0.75% HP-containing toothpaste (Vussen 7); and VH group (n = 17), 2.8% of HP-containing toothpaste (Vussen 28). Participants were instructed to manually brush their teeth for 3 minutes, three times per day, for 12 weeks (w). They were followed-up after 4 and 12 weeks. Shade measurements were performed using a spectrophotometer (SP), and data were calculated with CIELab ( ΔE ab * ) and CIEDE2000 (ΔE 00 ) formula. Additionally, visual inspection (VI) using the Vitapan classical shade guide was also performed, and the correlation between the two measurements was analyzed by comparing the CIELab ( ΔE ab * ) values. The incidence of contact hypersensitivity at each follow-up was recorded. A mixed-effect model was performed to assess shade changes and chi-square tests for the incidence of contact hypersensitivity, respectively.
RESULTS


At 12 week follow-up, all groups showed ΔE ab *  above 3.46, and ΔE 00  above 2.25 for tooth #11. For tooth #13, the ΔE ab *  and ΔE 00  of VH and TW groups only were above those thresholds. Shade change varied according to toothpaste and follow-up points. SP and VI showed a moderate positive correlation for L*, a*, and b*, respectively (P < 0.05). Contact hypersensitivity was not significantly different among the groups (P > 0.05).
CONCLUSIONS


Bleaching toothpaste with higher HP yields a better shade change than other toothpaste after 12 weeks.
CLINICAL SIGNIFICANCE


The use of bleaching toothpaste with a higher HP concentration results in a better shade improvement.",2020,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
",['Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13'],"['Bleaching toothpaste', 'HP-containing toothpaste (Toothwhole white); VL group (n\u2009=\u200915), 0.75% HP-containing toothpaste', 'HP-containing toothpaste', 'hydrogen peroxide', 'bleaching toothpaste']","['Contact hypersensitivity', 'incidence of contact hypersensitivity']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0162351', 'cui_str': 'Contact hypersensitivity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",49.0,0.12685,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
","[{'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Kyung Hee University Dental Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Dongseok', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea; Division of Biostatistics, Oregon Health and Science University, Portland State University of Public Health, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Shim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Duck-Su', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea. Electronic address: dentist96@khu.ac.kr.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103508']
2074,33122168,"Addition of aprepitant improves acute emesis control in children and adolescents receiving induction chemotherapy for acute myeloid leukaemia: a randomised, open-label trial.","OBJECTIVES


More than 50% patients develop emesis during induction therapy for acute myeloid leukaemia (AML). The addition of aprepitant for emesis control in children receiving induction for AML have not been explored.
METHODS


A single-institutional randomised, open-label trial (NCT02979548) was conducted where children between 5 and 18 years with the diagnosis of AML being planned for 3+7 induction regimen were included. All study participants received ondansetron (0.15 mg/kg) every 8 hours for 8 days starting 30 min prior to chemotherapy. Children belonging to aprepitant group additionally received aprepitant capsules (15-40 kg=days 1-3, 80 mg; >40 kg=day 1, 125 mg and days 2-3, 80 mg) starting from 1 hour prior to chemotherapy. The proportion of patients with complete response (CR) in chemotherapy induced vomiting (CIV) in acute phase (day 1-8), delayed phase (day 9-13), overall and initial 96 hours were recorded along with severity of vomiting and adverse effects.
RESULTS


Total 78 children were randomised (Aprepitant group: 37 and control group: 41). The proportion of patients with CR in CIV was significantly higher in Aprepitant group in acute phase (p=0.007), overall phase (p=0.007) and in initial 96 hours (p<0.001) but it was not different in delayed phase (p=0.07). The first episode of vomiting was also significantly delayed in aprepitant group (p=0.02). Adverse effect profile was similar in two groups.
CONCLUSION


Aprepitant significantly improves emesis control in children receiving induction therapy for AML, especially in acute phase and should be routinely incorporated as part of antiemetic prophylaxis.
TRIAL REGISTRATION NUMBER


The study was registered at ClinicalTrials.gov (NCT02979548).",2020,The first episode of vomiting was also significantly delayed in aprepitant group (p=0.02).,"['children receiving induction for AML', 'children receiving induction therapy for AML', 'acute myeloid leukaemia (AML', 'Total 78 children', 'children and adolescents receiving induction chemotherapy for acute myeloid leukaemia', 'children between 5 and 18 years with the diagnosis of AML being planned for 3+7 induction regimen were included']","['ondansetron', 'aprepitant capsules']","['vomiting (CIV', 'acute emesis control', 'Adverse effect profile', 'emesis control', 'severity of vomiting and adverse effects', 'proportion of patients with CR in CIV', 'vomiting', 'emesis', 'proportion of patients with complete response (CR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",78.0,0.140492,The first episode of vomiting was also significantly delayed in aprepitant group (p=0.02).,"[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shuvadeep', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'C', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwati S', 'Initials': 'AS', 'LastName': 'Pillai', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India sambakh@hotmail.com.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002595']
2075,33124504,BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS.,"BACKGROUND


There are few head-to-head studies to compare highly active treatments in multiple sclerosis (MS).
OBJECTIVE


The aim of this study was to compare the effectiveness between natalizumab (NTZ) and fingolimod (FTY) in active relapsing-remitting MS.
METHOD


Best Escalation STrategy in Multiple Sclerosis (BEST-MS) is a multicentric, prospective study with a 12-month follow-up including patients with active MS. Treatment choice was at the discretion of physician. Clinical and magnetic resonance imaging (MRI) data were collected at baseline and at 12 months. The primary outcome was the proportion of patients reaching no evidence of disease activity (NEDA) at 12 months. Secondary outcomes included annualized relapse rate and MRI activity.
RESULTS


A total of 223 patients were included (NTZ: 109 and FTY: 114). Treatment groups were well balanced at baseline. Proportion of NEDA patients was 47.8% in NTZ group versus 30.4% in FTY group ( p  = 0.015). This superiority was driven by annualized relapse rate and MRI activity. In the multivariate analysis, treatment group was the only factor associated with NEDA at 12 months with a lower probability in FTY group (odds ratio (OR) = 0.49,  p  = 0.029).
CONCLUSION


BEST-MS is a prospective study that compared head-to-head the effectiveness of NTZ and FTY in active relapsing-remitting MS. Our results suggest a superiority of NTZ over FTY.",2020,Proportion of NEDA patients was 47.8% in NTZ group versus 30.4% in FTY group ( p  = 0.015).,"['active relapsing-remitting MS', 'patients with active MS', 'A total of 223 patients were included (NTZ: 109 and FTY: 114', 'active relapsing MS', 'Multiple Sclerosis (BEST-MS']","['BEST-MS', 'NTZ', 'natalizumab (NTZ) and fingolimod (FTY', 'NTZ and FTY', 'natalizumab and fingolimod']","['annualized relapse rate and MRI activity', 'proportion of patients reaching no evidence of disease activity (NEDA']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",223.0,0.0470145,Proportion of NEDA patients was 47.8% in NTZ group versus 30.4% in FTY group ( p  = 0.015).,"[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ""Service de Neurologie, CRCSEP, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.""}, {'ForeName': 'Lydiane', 'Initials': 'L', 'LastName': 'Mondot', 'Affiliation': ""Service de Radiologie, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Bucciarelli', 'Affiliation': 'Neurosciences Department, CRCSEP, University Hospital of Toulouse, Toulouse, France/INSERM U1043-CNRS UMR 5282, Centre de Physiopathologie Toulouse, Toulouse, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Pignolet', 'Affiliation': 'Neurosciences Department, CRCSEP, University Hospital of Toulouse, Toulouse, France/INSERM U1043-CNRS UMR 5282, Centre de Physiopathologie Toulouse, Toulouse, France.'}, {'ForeName': 'David-Axel', 'Initials': 'DA', 'LastName': 'Laplaud', 'Affiliation': 'CRTI-INSERM U1064, CIC 1413, Service de Neurologie, CHU Nantes, Nantes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Wiertlewski', 'Affiliation': 'CRTI-INSERM U1064, CIC 1413, Service de Neurologie, CHU Nantes, Nantes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Service de Neurologie, CRC SEP, Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Service de Neurologie, CRC SEP, Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Defer', 'Affiliation': 'Service de Neurologie, CHU de Caen, Avenue de la Côte de Nacre, Caen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Derache', 'Affiliation': 'Service de Neurologie, CHU de Caen, Avenue de la Côte de Nacre, Caen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, INSERM U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Zephir', 'Affiliation': 'Univ. Lille, INSERM U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'CHRU-Nancy, INSERM, Université de Lorraine, CIC, Epidémiologie Clinique, Nancy, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mathey', 'Affiliation': 'CHRU-Nancy, INSERM, Université de Lorraine, CIC, Epidémiologie Clinique, Nancy, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Service de Neurologie, CHU de Besançon, Besançon, France.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Cappé', 'Affiliation': ""Centre d'investigation clinique, CHU de Besançon, Besançon, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Labauge', 'Affiliation': 'CHU de Montpellier, MS Unit, Montpellier, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Carra', 'Affiliation': 'CHU de Montpellier, MS Unit, Montpellier, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'De Seze', 'Affiliation': 'Clinical Investigation Center, Department of Neurology, CHU de Strasbourg, INSERM 1434, Strasbourg, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bigaut', 'Affiliation': 'Clinical Investigation Center, Department of Neurology, CHU de Strasbourg, INSERM 1434, Strasbourg, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brassat', 'Affiliation': 'Neurosciences Department, CRCSEP, University Hospital of Toulouse, Toulouse, France/INSERM U1043-CNRS UMR 5282, Centre de Physiopathologie Toulouse, Toulouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebrun-Frenay', 'Affiliation': ""Service de Neurologie, CRCSEP, Unité de Recherche Clinique Cote d'Azur (UR2CA), Centre Hospitalier Universitaire Pasteur 2, Nice, France.""}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520969145']
2076,33124506,Intensified Oral Hygiene Care in Stroke-Associated Pneumonia: A Pilot Single-Blind Randomized Controlled Trial.,"In this pilot, single-blind, randomized controlled trial, we investigated the effects of intensified oral hygiene care (IOHC) on reducing stroke-associated pneumonia (SAP) incidence. Patients admitted within 24 hours of stroke onset were recruited and randomized to receive IOHC or routine oral hygiene care. The occurrence of SAP was checked and oral swabs were obtained during the 7-day follow-up. The SAP incidence was lower, though not significantly, in the IOHC group than in the control group. IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores. Furthermore, IOHC significantly decreased the prevalence of oral suspected SAP pathogens. These results suggest that IOHC can decrease the incidence of SAP in the most vulnerable patient groups and lower the prevalence of suspected oral SAP pathogens.",2020,"IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores.","['Stroke-Associated Pneumonia', 'Patients admitted within 24\u2009hours of stroke onset']","['IOHC or routine oral hygiene care', 'intensified oral hygiene care (IOHC', 'IOHC', 'Intensified Oral Hygiene Care']","['occurrence of SAP', 'SAP incidence', 'stroke-associated pneumonia (SAP) incidence', 'Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores', 'prevalence of oral suspected SAP pathogens', 'incidence of SAP']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3536594', 'cui_str': 'Suspected cerebrovascular accident'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",,0.047624,"IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yuan', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of VIP Service, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}]","Inquiry : a journal of medical care organization, provision and financing",['10.1177/0046958020968777']
2077,33124563,Impact of a pharmacist-led programme on biologics knowledge and adherence in patients with spondyloarthritis.,"OBJECTIVES


In spondyloarthritis (SpA), improving patients' knowledge on their biologics is a key factor to enhance adherence. The information given to the patient has to ensure the acquisition of safety skills regarding their treatment. The aims of this trial were to evaluate the impact of a pharmacist's educational interview on knowledge and adherence to biologics in these patients.
METHODS


Consecutive adult patients with well-controlled axial SpA, stable on biologics were enrolled in a randomised, controlled, single-centre, open-label, 6-month trial. A pharmacist's educational interview provided information on biologics management at baseline in the intervention group and at month 6 in the control group. The changes in a weighted knowledge score concerning the management of biologics and the change in the Medication Possession Ratio (MPR) at month-6 were primary outcomes. The changes in disease activity (BASDAI) and patients' satisfaction regarding the pharmacists' interview were secondary outcomes.
RESULTS


Patients' characteristics at baseline were comparable among the 89 included patients (46 in the intervention group, 43 in the control group). The patient's knowledge score concerning biologics management improved at a greater magnitude in the educational group (+11.0±11.5 vs. +3.0 ±10.6 in the intervention versus the control group, respectively, p<0.0001). There was also a trend in a better adherence (+2.2±13.9 vs. -0.6±18.9 in the intervention versus the control group, respectively, p=0.691). The disease activity remained stable in both groups.
CONCLUSIONS


This study is strongly in favour of the benefit of a pharmacist's educational interview in the management of patients with axial SpA.",2020,"The patient's knowledge score concerning biologics management improved at a greater magnitude in the educational group (+11.0±11.5 vs. +3.0 ±10.6 in the intervention versus the control group, respectively, p<0.0001).","['patients with axial SpA', 'Consecutive adult patients with well-controlled axial SpA, stable on biologics', 'patients with spondyloarthritis']","[""pharmacist's educational interview"", 'pharmacist-led programme']","['disease activity', 'knowledge and adherence to biologics', 'biologics knowledge and adherence', 'disease activity (BASDAI', 'Medication Possession Ratio (MPR', 'better adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",89.0,0.0541381,"The patient's knowledge score concerning biologics management improved at a greater magnitude in the educational group (+11.0±11.5 vs. +3.0 ±10.6 in the intervention versus the control group, respectively, p<0.0001).","[{'ForeName': 'Loriane', 'Initials': 'L', 'LastName': 'Gutermann', 'Affiliation': 'Department of Pharmacy, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, France. gutermann.loriane@gmail.com.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dumas', 'Affiliation': 'Department of Pharmacy, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'Lopez-Medina', 'Affiliation': 'Department of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris; INSERM (U1153), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Boissinot', 'Affiliation': 'Department of Pharmacy, Hôpital Sud-francillien, Corbeil-Essones, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Cotteret', 'Affiliation': 'Department of Pharmacy, Hôpital Necker Enfants-Malades, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Perut', 'Affiliation': 'Department of Risk and Quality Management, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Department of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris; INSERM (U1153), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Conort', 'Affiliation': 'Department of Pharmacy, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris; INSERM (U1153), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.'}]",Clinical and experimental rheumatology,[]
2078,33124591,"A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia.","Objective


: Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease.
Methods


It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann-Whitney  U  test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher's exact test, as appropriate.
Results


The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant ( p  < 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients.
Conclusion


Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.",2020,The decline in CGI-S and CGI-I scores was statistically significant ( p  < 0.001) when compared between visits of any of the both treatment arms.,['Total 80 subjects were enrolled as per eligibility criteria'],"['olanzapine', 'trial medication (Olanzapine 10 mg or Asenapine', 'Asenapine versus Olanzapine', 'atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine', 'asenapine', 'antipsychotic medication']","['BPRS score', 'Efficacy, Safety and Tolerability', 'decline in CGI-S and CGI-I scores', 'BPRS, CGI-S, CGI', 'duration of schizophrenia at presentation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}, {'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",80.0,0.0257721,The decline in CGI-S and CGI-I scores was statistically significant ( p  < 0.001) when compared between visits of any of the both treatment arms.,"[{'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Pharmacology, RG Kar Medical College, India.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Neonatology, AMRI Hospital, Kolkata, India.'}, {'ForeName': 'Asim Kumar', 'Initials': 'AK', 'LastName': 'Mallick', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Supreeti', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.587']
2079,33124599,"Corrigendum: A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Pharmacogenomic-based Antidepressant Treatment'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0941954,,"[{'ForeName': 'Changsu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sheng-Min', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Won-Myong', 'Initials': 'WM', 'LastName': 'Bahk', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Prakash S', 'Initials': 'PS', 'LastName': 'Masand', 'Affiliation': 'Global Medical Education, New York, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandelli', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Chi-Un', 'Initials': 'CU', 'LastName': 'Pae', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Serretti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.641']
2080,33124663,Rapamycin Plus Vildagliptin to Recover ß Cell Function in Long Standing Type 1 Diabetes: A Double Blind Randomized Trial.,"AIM


The aim of this study was to investigate whether treatment with rapamycin plus vildagliptin restores beta-cell function in patients with long-standing type 1 diabetes.
METHODS


A phase 2, single-center randomized, double-blind, placebo-controlled study was conducted in long-standing type 1 diabetes patients randomized (1:1:1) to 4 weeks rapamycin (Group 2), 4 weeks rapamycin plus 12 weeks vildagliptin (Group 3) or double placebo (Group 1). Primary outcome was the proportion of participants with a positive response to the Mixed Meal Tolerance Test (C-peptide at 90 min >0.2 nmol/L) at week 4 and 12. Secondary endpoints included insulin requirement, standard measures of glycemic control, hormonal and immunological profile.
RESULTS


Fifty-five patients were randomized to Group 1 (n=18), Group 2 (n=19) or Group 3 (n=18). No patient in any group showed a positive C-peptide response and there was no significant difference at 4 and 12 weeks for the primary outcome. At four week insulin requirement decreased from 0.54 to 0.48 U/kg/day in Group 2 (p = 0.013), from 0.59 to 0.51 U/kg/day in Group 3 (p <0.001), while it did not change in Group 1. At 12 week HbA1c significantly decreased both in Group 2 [from 7.3% (56 mmol/mol) to 7% (53 mmol/mol); p= 0.045] and in Group 3 [from 7.2% (55.5 mmol/mol) to 6.9% (52 mmol/mol); p=0.001]. Rapamycin treatment was associated with a decrease in insulin antibody titer and changes in hormonal/immunological profile.
CONCLUSIONS


Rapamycin reduced insulin requirement, but did not restore beta-cell function in patients with long-standing type 1 diabetes.",2020,No patient in any group showed a positive C-peptide response and there was no significant difference at 4 and 12 weeks for the primary outcome.,"['Fifty-five patients', 'long-standing type 1 diabetes patients', 'Long Standing Type 1 Diabetes', 'patients with long-standing type 1 diabetes']","['rapamycin plus vildagliptin', 'Rapamycin', 'Rapamycin Plus Vildagliptin', 'rapamycin plus 12 weeks vildagliptin (Group 3) or double placebo', 'placebo', 'rapamycin']","['insulin requirement, standard measures of glycemic control, hormonal and immunological profile', 'insulin antibody titer and changes in hormonal/immunological profile', 'restore beta-cell function', 'proportion of participants with a positive response to the Mixed Meal Tolerance Test', 'positive C-peptide response']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0021644', 'cui_str': 'Anti-insulin antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",55.0,0.410679,No patient in any group showed a positive C-peptide response and there was no significant difference at 4 and 12 weeks for the primary outcome.,"[{'ForeName': 'Andrea Mario', 'Initials': 'AM', 'LastName': 'Bolla', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Gandolfi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Borgonovo', 'Affiliation': 'Università Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Laurenzi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Caretto', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinari', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Roberta Sara', 'Initials': 'RS', 'LastName': 'Catalano', 'Affiliation': 'Università Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Bianconi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Monti', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Sordi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellegrini', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lampasona', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Costa', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Scavini', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Piemonti', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa791']
2081,33124733,Comparison of different pulmonary valve reconstruction techniques during transannular repair of tetralogy of fallot.,"BACKGROUND


Transannular patch, which results in pulmonary insufficiency (PI), is usually required during repair of tetralogy of fallot (TOF). In this study, we compared three types of pulmonary valve reconstruction techniques during transannular repair of TOF.
METHODS


Between February 2014 and January 2018, 50 patients with TOF underwent primary repair with transannular patch. These patients were divided into three groups. In Group 1, (n = 15), a single gluteraldehyde-treated autologous pericardial patch (standard method) was reconstructed as monocusp. In Group 2, (n = 16) Nunn's bileaflet pulmonary valve reconstruction technique was used with pericardial patch. In Group 3, (n = 19), Nunn's bileaflet technique was performed with expanded polytetrafluoroethylene membrane. The outcomes of the patients and early and midterm competency of the pulmonary valves were analyzed.
RESULTS


These techniques were significantly effective in early postoperative period. Freedom from moderate to severe PI were 73.3%; 100% and 89.4%, respectively. Mortality, duration of intensive care unit and hospital stay were similar between the groups. The mean follow-up period was 17.5 ± 13.0 (3-57) months. Freedom from moderate to severe PI decreased to 40%; 81.2% and 73.7%, respectively at the end of the follow-up period. Presence of moderate to severe PI was significantly higher in Group 1 (p = .018 between Groups 1 and 2, p = .048 between Groups 1 and 3).
CONCLUSION


All three pulmonary valve reconstruction techniques provided competent pulmonary valves. Nunn's bileaflet technique had better outcome at midterm. It has a potential to delay right ventricular dysfunction at long-term.",2020,"Presence of moderate to severe PI was significantly higher in Group 1 (p = .018 between Groups 1 and 2, p = .048 between Groups 1 and 3).
","['transannular repair of tetralogy of fallot', 'Between February 2014 and January 2018, 50 patients with TOF underwent primary repair with transannular patch']","['pulmonary valve reconstruction techniques during transannular repair of TOF', 'expanded polytetrafluoroethylene membrane', 'pulmonary valve reconstruction techniques', 'single gluteraldehyde-treated autologous pericardial patch']","['Presence of moderate to severe PI', 'Mortality, duration of intensive care unit and hospital stay', 'severe PI']","[{'cui': 'C0581772', 'cui_str': 'Transannular'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0034086', 'cui_str': 'Pulmonary valve structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0581772', 'cui_str': 'Transannular'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0440774', 'cui_str': 'Pericardial patch'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0034088', 'cui_str': 'Pulmonic valve regurgitation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",50.0,0.0145039,"Presence of moderate to severe PI was significantly higher in Group 1 (p = .018 between Groups 1 and 2, p = .048 between Groups 1 and 3).
","[{'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Temur', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Aydın', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Suzan', 'Affiliation': 'Department of Cardiovascular Surgery, Gaziosmanpaşa Hospital, Yeni Yüzyıl University, Istanbul, Turkey.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Kırat', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Florence Nightingale Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ibrahim Halil', 'Initials': 'IH', 'LastName': 'Demir', 'Affiliation': 'Department of Pediatric Cardiology, Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Erek', 'Affiliation': 'Department of Cardiovascular Surgery, School of Medicine, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey.'}]",Journal of cardiac surgery,['10.1111/jocs.15133']
2082,33124759,Cross-cultural validation of the patient-practitioner orientation scale among primary care professionals in Spain.,"BACKGROUND


In recent decades, many self-report instruments have been developed to assess the extent to which patients want to be informed and involved in decisions about their health as part of the concept of person-centred care (PCC). The main objective of this research was to translate, adapt and validate the Patient-Practitioner Orientation Scale (PPOS) using a sample of primary care health-care professionals in Spain.
METHODS


Baseline analysis of PPOS scores for 321 primary care professionals (general practitioners and nurses) from 63 centres and 3 Spanish regions participating in a randomized controlled trial. We analysed missing values, distributions and descriptive statistics, item-to-scale correlations and internal consistency. Performed were confirmatory factor analysis (CFA) of the 2-factor model (sharing and caring dimensions), scale depuration and principal component analysis (PCA).
RESULTS


Low inter-item correlations were observed, and the CFA 2-factor model only obtained a good fit to the data after excluding 8 items. Internal consistency of the 10-item PPOS was acceptable (0.77), but low for individual subscales (0.70 and 0.55). PCA results suggest a possible 3-factor structure. Participants showed a patient-oriented style (mean = 4.46, SD = 0.73), with higher scores for caring than sharing.
CONCLUSION


Although the 2-factor model obtained empirical support, measurement indicators of the PPOS (caring dimension) could be improved. Spanish primary care health-care professionals overall show a patient-oriented attitude, although less marked in issues such as patients' need for and management of medical information.",2020,"Spanish primary care health-care professionals overall show a patient-oriented attitude, although less marked in issues such as patients' need for and management of medical information.","['primary care professionals in Spain', '321 primary care professionals (general practitioners and nurses) from 63 centres and 3 Spanish regions participating in a randomized controlled trial', 'primary care health-care professionals in Spain']",[],"['patient-oriented style', 'Patient-Practitioner Orientation Scale (PPOS', 'Internal consistency of the 10-item PPOS']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",,0.0379035,"Spanish primary care health-care professionals overall show a patient-oriented attitude, although less marked in issues such as patients' need for and management of medical information.","[{'ForeName': 'Lilisbeth', 'Initials': 'L', 'LastName': 'Perestelo-Pérez', 'Affiliation': 'Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Rivero-Santana', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'González-González', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Carlos Jesús', 'Initials': 'CJ', 'LastName': 'Bermejo-Caja', 'Affiliation': 'Support Unit for Primary Care, Community of Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ramos-García', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Koatz', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Alezandra', 'Initials': 'A', 'LastName': 'Torres-Castaño', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ballester', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Muñoz-Balsa', 'Affiliation': 'Nursing Department, Autonomus University of Madrid, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Del Rey-Granado', 'Affiliation': 'Nursing Department, Autonomus University of Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Pérez-Rivas', 'Affiliation': 'Nursing Department, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Canellas-Criado', 'Affiliation': 'Primary Care Centre Monóvar, Community of Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Ramírez-Puerta', 'Affiliation': 'Nursing Department, Autonomus University of Madrid, Madrid, Spain.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pacheco-Huergo', 'Affiliation': 'EAP Turó, Barcelona, Spain.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Orrego', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13135']
2083,33124895,Probiotics diminish the post-operatory pain following mandibular third molar extraction: a randomised double-blind controlled trial (pilot study).,"The aim of this study was to investigate the effect of a probiotic in preventing infections after third molar surgery. Thirty-eight patients were consecutively enrolled to a double-blind randomised placebo-controlled trial. Patients were asked to take one tablet two times a day containing a mixture of  Levilactobacillus brevis  CECT7480 (KABP-052) and  Lactoplantibacillus plantarum  CECT7481 (KABP-051) or placebo for the first post-intervention week. The primary outcome was the postoperative infection rate. Secondary outcomes included swelling, eating difficulties and postoperative pain recorded by the patient using a visual analogue scale (VAS) during the first postoperative week. No statistically significant difference in the infection rate between the groups was found; with only three cases of infections reported (one in the probiotic group and two in the placebo group) on the first week. Compared to placebo, treatment with the probiotic showed a significantly higher reduction in pain and eating difficulties scores at 5, 6 and 7 days post-surgery. Swelling values were not significantly different between the groups at any time point. The findings of this pilot study justify a larger study to clarify the possible role of these bacterial strains on the post-operative pain management following third molar surgery.",2020,"Compared to placebo, treatment with the probiotic showed a significantly higher reduction in pain and eating difficulties scores at 5, 6 and 7 days post-surgery.","['third molar surgery', 'Thirty-eight patients', 'mandibular third molar extraction']","['CECT7481 (KABP-051) or placebo', 'CECT7480 (KABP-052) and  Lactoplantibacillus plantarum', 'mixture of  Levilactobacillus brevis', 'placebo', 'Probiotics']","['infection rate', 'pain and eating difficulties scores', 'postoperative infection rate', 'Swelling values', 'swelling, eating difficulties and postoperative pain recorded by the patient using a visual analogue scale (VAS']","[{'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518085', 'cui_str': 'Difficulty eating'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.471288,"Compared to placebo, treatment with the probiotic showed a significantly higher reduction in pain and eating difficulties scores at 5, 6 and 7 days post-surgery.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ferrés-Amat', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, HM Nens, HM Hospitales, 08009 Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Espadaler-Mazo', 'Affiliation': 'AB-BIOTICS SA, 08172 Sant Cugat del Vallès, Barcelona, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Calvo-Guirado', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, Faculty of Health Sciences, Universidad Católica de Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ferrés-Amat', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, HM Nens, HM Hospitales, 08009 Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mareque-Bueno', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, HM Nens, HM Hospitales, 08009 Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salavert', 'Affiliation': 'AB-BIOTICS SA, 08172 Sant Cugat del Vallès, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aguiló-García', 'Affiliation': 'AB-BIOTICS SA, 08172 Sant Cugat del Vallès, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Moreno-Centeno', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, HM Nens, HM Hospitales, 08009 Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ferrés-Padró', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, HM Nens, HM Hospitales, 08009 Barcelona, Spain.'}]",Beneficial microbes,['10.3920/BM2020.0090']
2084,33124886,Inhibition of iNOS augments cutaneous endothelial NO-dependent vasodilation in prehypertensive non-Hispanic Whites and in non-Hispanic Blacks.,"We tested the hypothesis that inducible NO synthase (iNOS) contributes to reduced NO-dependent vasodilation in non-Hispanic Blacks and prehypertensive non-Hispanic Whites. Twenty Black and 20 White participants (10 normotensive, 10 prehypertensive per group; n=40 total) participated in this study. Participants were instrumented with two microdialysis fibers and each site was randomized as control (lactated Ringer's) or iNOS inhibition (0.1 mM 1400W). Laser-Doppler flow probes and local heaters were used to measure skin blood flow and heat the skin to induce vasodilation, respectively. Each site was heated from 33°C to 39°C (rate: 0.1°C/sec). Once a plateau was established, 20 mM L-NAME, a non-specific NOS inhibitor, was infused at each site to quantify NO-dependent vasodilation. At control sites, %NO-dependent vasodilation was reduced in prehypertensive Whites (47 ± 10 %NO) and in both normotensive and prehypertensive Blacks (39 ± 9 and 28 ± 5 %NO, respectively) relative to normotensive Whites (73 ± 8 %NO; p < 0.0001 all comparisons). Compared to respective control sites, iNOS inhibition increased NO-dependent vasodilation in prehypertensive Whites (68 ± 8 %NO) and in both normotensive and prehypertensive Blacks (78 ± 8 and 55 ± 6 %NO, respectively; p < 0.0001 all comparisons). We failed to find an effect for normotensive Whites (77 ± 7 %NO). Following iNOS inhibition, %NO-dependent vasodilation was similar between normotensive Whites, prehypertensive Whites, and normotensive Blacks. Inhibition of iNOS increased NO-dependent vasodilation to a lesser extent in prehypertensive Blacks. These data suggest iNOS contributes to reduced NO-dependent vasodilation in prehypertension and in Black participants.",2020,"Following iNOS inhibition, %NO-dependent vasodilation was similar between normotensive Whites, prehypertensive Whites, and normotensive Blacks.","['normotensive Whites (77 ± 7 %NO', 'prehypertensive non-Hispanic Whites and in non-Hispanic Blacks', 'Twenty Black and 20 White participants (10 normotensive, 10 prehypertensive per group; n=40 total) participated in this study']","[""control (lactated Ringer's) or iNOS inhibition""]","['vasodilation', 'iNOS inhibition increased NO-dependent vasodilation']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0669372', 'cui_str': 'NOS2A protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0669372', 'cui_str': 'NOS2A protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]",20.0,0.0341709,"Following iNOS inhibition, %NO-dependent vasodilation was similar between normotensive Whites, prehypertensive Whites, and normotensive Blacks.","[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Miller', 'Affiliation': 'Kinesiology & Health, Georgia State University, United States.'}, {'ForeName': 'Casey G', 'Initials': 'CG', 'LastName': 'Turner', 'Affiliation': 'Kinesiology & Health, Georgia State University, United States.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Otis', 'Affiliation': 'Kinesiology & Health, Georgia State University, United States.'}, {'ForeName': 'Yesser', 'Initials': 'Y', 'LastName': 'Sebeh', 'Affiliation': 'School of Public Health, Georgia State University, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'School of Public Health, Georgia State University, United States.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, United States.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Wong', 'Affiliation': 'Department of Kinesiology & Health, Georgia State University, United States.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00644.2020']
2085,33124900,Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial.,"Objectives:  Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortality in China. In the IMPACT trial, fluticasone furoate[FF]/umeclidinium[UMEC]/vilanterol[VI] single-inhaler triple therapy demonstrated lower rates of moderate/severe exacerbations than dual therapy with FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. This analysis investigates the China cohort and its consistency with the overall ITT population.  Methods:  10,355 patients were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg for 52 weeks. Endpoints included: annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation and change from baseline in trough forced expiratory volume in 1 second (FEV 1 ) at Week-52. Clinical trial registration is NCT02164513 (CTT116855).  Results:  535 patients (5.2%) were from China. Annual on-treatment moderate/severe exacerbation rate was 0.81 with FF/UMEC/VI versus 0.96 with FF/VI (rate ratio: 0.84; 95% confidence interval [CI]: 0.64, 1.11; p = 0.227) and 0.80 with UMEC/VI (rate ratio: 1.02; 95% CI: 0.72, 1.44; p = 0.929). Hazard ratio for time-to-first moderate/severe exacerbation was 0.84 (95% CI: 0.63, 1.11; p = 0.218) for FF/UMEC/VI versus FF/VI and 0.89 (95% CI: 0.62, 1.27; p = 0.516) versus UMEC/VI. Significant improvements in mean change from baseline in trough FEV 1  were observed for FF/UMEC/VI versus FF/VI (treatment difference 137mL; 95% CI: 86, 188; p < 0.001) and UMEC/VI (63mL; 0, 125; p = 0.050). Health status was improved with FF/UMEC/VI versus both dual therapies. Results were similar to the overall ITT population. No new safety signals were identified.  Conclusions:  Single-inhaler triple therapy with FF/UMEC/VI versus FF/VI or UMEC/VI reduced the rate and risk of exacerbations, and improved lung function and health status in the China cohort similar to the overall ITT population. No new safety signals were identified.",2020,"Significant improvements in mean change from baseline in trough FEV 1  were observed for FF/UMEC/VI versus FF/VI (treatment difference 137mL; 95% CI: 86, 188; p < 0.001) and UMEC/VI (63mL; 0, 125; p = 0.050).","['535 patients (5.2%) were from China', 'Chronic obstructive pulmonary disease (COPD', '10,355 patients', 'patients with COPD', 'patients with symptomatic COPD and a history of exacerbations']","['daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI', 'fluticasone furoate[FF]/umeclidinium[UMEC]/vilanterol[VI', 'FF/UMEC/VI versus FF/VI or UMEC', 'Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI']","['severe exacerbation rate', 'rate and risk of exacerbations, and improved lung function and health status', 'Hazard ratio for time-to-first moderate/severe exacerbation', 'Health status', 'annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation and change from baseline in trough forced expiratory volume in 1\u2009second (FEV 1 ) at Week-52', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439230', 'cui_str': 'week'}]",10355.0,0.730826,"Significant improvements in mean change from baseline in trough FEV 1  were observed for FF/UMEC/VI versus FF/VI (treatment difference 137mL; 95% CI: 86, 188; p < 0.001) and UMEC/VI (63mL; 0, 125; p = 0.050).","[{'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Li Ping', 'Initials': 'LP', 'LastName': 'Wei', 'Affiliation': 'Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xiang Dong', 'Initials': 'XD', 'LastName': 'Zhou', 'Affiliation': 'Xinan Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Dong Yuan', 'Affiliation': 'Respiratory Department, The Second Hospital of Hebei Medical University, Shijazhuang, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, Collegeville, PA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1844646']
2086,33124968,Effects of Multilayer Silicone Foam Dressings for the Prevention of Pressure Ulcers in High-Risk Patients: A Randomized Clinical Trial.,"Objective:  To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin.  Approach:  This randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were randomized using the Excel program to receive standard care (control;  n  = 300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention;  n  = 300).  Results:  Significantly more participants in the control than the intervention group developed pressure ulcers (22 vs. 5,  p  = 0.001).  Innovation:  The incidence of pressure ulcers remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers.  Conclusion:  Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.",2020,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"['patients with persistent severe diarrhea and/or fragile skin', 'All participants were enrolled from three Japanese institutions', '600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers', 'High-Risk Patients', 'patients at high risk of developing pressure ulcers', 'hospitalized patients at high risk of developing pressure ulcers', 'Participants meeting all inclusion and exclusion criteria']","['multilayer silicone foam dressings', 'Excel program to receive standard care (control;  n \u2009=\u2009300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention;  n \u2009=\u2009300', 'Multilayer silicone foam dressings', 'Multilayer Silicone Foam Dressings']","['Pressure Ulcers', 'pressure ulcers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0241181', 'cui_str': 'Fragile skin'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0009194', 'cui_str': 'Bone structure of coccyx'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]",600.0,0.049254,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oe', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Nursing, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Takaki', 'Affiliation': 'Department of Nursing, Fukuseikai Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Sanada', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Advances in wound care,['10.1089/wound.2019.1002']
2087,33124985,"Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0744143,,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saishoji', 'Affiliation': 'Department of General Internal Medicine, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiroshita', 'Affiliation': 'Department of Pulmonology, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Japan.'}]",Journal of medical Internet research,['10.2196/21505']
2088,33125033,"Osteopathic Manipulative Treatment in Individuals With Vertigo and Somatic Dysfunction: A Randomized, Controlled, Comparative Feasibility Study.","Context


There is a paucity of research assessing the efficacy of osteopathic manipulative treatment (OMT) in patients with vertigo.
Objective


To assess the feasibility of conducting a randomized, controlled trial comparing OMT and vestibular rehabilitation therapy (VRT), alone or in combination, in patients with vertigo and somatic dysfunction.
Methods


Volunteers with vertigo who were also diagnosed with somatic dysfunction (SD) were prospectively enrolled in a blinded, randomized, controlled cohort comparative effectiveness study and assigned to 1 of 4 groups: OMT alone, VRT alone, a combination of OMT and VRT (OMT/VRT), or a nonintervention control group. Participants between 18 and 79 years of age were included if they had experienced symptoms of vertigo for at least 3 months' duration, demonstrated somatic dysfunction, and could participate in computerized dynamic posturography (CDP) testing, tolerate manual therapy and exercises, and communicate effectively in English or Spanish. A total of 3 treatments lasting 45 minutes each were administered 1 week apart to each participant. OMT in this study consisted of counterstrain, myofascial release, balanced ligamentous tension, soft tissue, HVLA, and articulatory techniques. Comparisons were made between composite scores (CS) assessed with computerized dynamic posturography (CDP), dizziness handicap inventory (DHI), optometric evaluation, and osteopathic structural examinations collected before the first treatment, after the third/final treatment, and 3 months after the final treatment. (ClinicalTrials.gov number NCT01529151).
Results


A total of 23 patients were included in the study: 7 in the OMT group, 5 in the VRT group, 6 in the OMT/VRT group, and 5 in the control group. The OMT/VRT group demonstrated significant improvement in DHI score (P=.0284) and CS (P=.0475) between pre- and 3-month posttreatment measures. For total severity, improvements were significant in the OMT group both from pretreatment to immediate posttreatment measures (P=.0114) and from pretreatment to 3-month posttreatment measures (P=.0233). There was a statistical difference between the OMT and control groups from pretreatment to 3-month posttreatment DHI scores (P=.0332). Also, there was a statistical difference in DHI score between VRT and control from pre- to 3-month posttreatment scores (P=.0338). OMT/VRT statistically and clinically improved visual acuity in patients' right eyes from pre- to posttreatment (P=.0325). In all participants, vergence dysfunction was prevalent (5; 21.7%) in addition to vertical heterophoria (15; 65.2%).
Conclusion


A combination of OMT and VRT significantly reduced vertigo and improved balance 3 months after treatment (P<.0.05). There was a high prevalence in vergence and vertical heterophoria, which are not typical screening measurements used by physical therapists and physicians to assess vertigo patients. With a small sample size, this study demonstrated the feasibility of an interdisciplinary team evaluating and treating patients with vertigo in a community setting. A larger study is needed to assess the efficacy of OMT/VRT in vertigo patients.",2020,There was a statistical difference between the OMT and control groups from pretreatment to 3-month posttreatment DHI scores (P=.0332).,"['Individuals With Vertigo and Somatic Dysfunction', '23 patients were included in the study: 7 in the OMT group, 5 in the VRT group, 6 in the OMT/VRT group, and 5 in the control group', 'patients with vertigo', 'patients with vertigo and somatic dysfunction', 'patients with vertigo in a community setting', ""Participants between 18 and 79 years of age were included if they had experienced symptoms of vertigo for at least 3 months' duration, demonstrated somatic dysfunction, and could participate in computerized dynamic posturography (CDP) testing, tolerate manual therapy and exercises, and communicate effectively in English or Spanish"", 'vertigo patients', 'Volunteers with vertigo who were also diagnosed with somatic dysfunction (SD']","['OMT and VRT', 'OMT', 'OMT/VRT', 'osteopathic manipulative treatment (OMT', 'Osteopathic Manipulative Treatment', 'OMT and vestibular rehabilitation therapy (VRT', 'OMT alone, VRT alone, a combination of OMT and VRT (OMT/VRT), or a nonintervention control group']","['vertigo', 'visual acuity', 'vergence dysfunction', 'composite scores (CS) assessed with computerized dynamic posturography (CDP), dizziness handicap inventory (DHI), optometric evaluation, and osteopathic structural examinations', 'DHI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0264202', 'cui_str': 'Somatic dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1562073', 'cui_str': 'Osteopathic structural examination'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}]",23.0,0.057572,There was a statistical difference between the OMT and control groups from pretreatment to 3-month posttreatment DHI scores (P=.0332).,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Fraix', 'Affiliation': ''}, {'ForeName': 'Sondos', 'Initials': 'S', 'LastName': 'Badran', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Redman-Bentley', 'Affiliation': ''}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Hurwitz', 'Affiliation': ''}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Quan', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Yim', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hudson-McKinney', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Seffinger', 'Affiliation': ''}]",The Journal of the American Osteopathic Association,['10.7556/jaoa.2020.147']
2089,33125080,Relationship of IGF-1 and IGF Binding Proteins to Disease Severity and Glycemia in Non-Alcoholic Fatty Liver Disease.,"CONTEXT


GH and IGF-1 help regulate hepatic glucose and lipid metabolism, and reductions in these hormones may contribute to development of nonalcoholic fatty liver disease (NAFLD).
OBJECTIVE


To assess relationships between hepatic expression of IGF1 and IGF binding proteins (IGFBPs) and measures of glycemia and liver disease in adults with NAFLD. Secondarily to assess effects of GH releasing hormone (GHRH) on circulating IGFBPs.
DESIGN


Analysis of data from a randomized clinical trial of GHRH.
SETTING


Two US academic medical centers.
PARTICIPANTS


61 men and women 18-70yo with HIV-infection, ≥5% hepatic fat fraction, including 39 with RNA-Seq data from liver biopsy.
MAIN OUTCOME MEASURES


Hepatic steatosis, inflammation, and fibrosis by histopathology and measures of glucose homeostasis.
RESULTS


Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1. Among the IGFBP's, IGFBP2 and IGFBP4 were lower and IGFBP6 and IGFBP7 (also known as IGFBP-related protein 1) higher with increasing steatosis. Hepatic IGFBP6 and IGFBP7 mRNA were positively associated with NAS. IGFBP7 mRNA increased with increasing fibrosis. Hepatic IGFBP1 mRNA was inversely associated with glycemia and insulin resistance, with opposite relationships present for IGFBP3 and IGFBP7. GHRH increased circulating IGFBP-1 and IGFBP-3, but decreased IGFBP-2 and IGFBP-6.
CONCLUSIONS


These data demonstrate novel relationships of IGF-1 and IGFBPs with NAFLD severity and glucose control, with divergent roles seen for different IGFBPs. Moreover, the data provide new information on the complex effects of GHRH on IGFBPs.",2020,"RESULTS


Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1.","['61 men and women 18-70yo with HIV-infection, ≥5% hepatic fat fraction, including 39 with RNA-Seq data from liver biopsy', 'adults with NAFLD', 'Two US academic medical centers']",['GH releasing hormone (GHRH'],"['IGFBP6 and IGFBP7', 'IGFBP7 mRNA', 'glycemia and insulin resistance', 'IGFBP-2 and IGFBP-6', 'Hepatic IGFBP1 mRNA', 'Hepatic steatosis, inflammation, and fibrosis by histopathology and measures of glucose homeostasis', 'IGFBP2 and IGFBP4', 'NAFLD Activity Score (NAS', 'Hepatic IGF1 mRNA', 'Hepatic IGFBP6 and IGFBP7 mRNA', 'circulating IGFBP-1 and IGFBP-3']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0123257', 'cui_str': 'Insulin-like growth factor binding protein 2'}, {'cui': 'C0169975', 'cui_str': 'IGFBP-6'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1295163', 'cui_str': 'Insulin-like growth factor binding protein 2 measurement'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}]",61.0,0.0286818,"RESULTS


Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1.","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'McClure', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa792']
2090,33125166,Comparative effectiveness of external vs blended facilitation on collaborative care model implementation in slow-implementer community practices.,"OBJECTIVE


To evaluate the comparative effectiveness of external facilitation (EF) vs external + internal facilitation (EF/IF), on uptake of a collaborative chronic care model (CCM) in community practices that were slower to implement under low-level implementation support.
STUDY SETTING


Primary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12 months following randomization.
STUDY DESIGN


Sites that failed to meet a pre-established implementation benchmark after six months of low-level implementation support were randomized to add either EF or EF/IF support for up to 12 months. Key outcomes were change in number of patients receiving the CCM and number of patients receiving a clinically significant dose of the CCM. Moderators' analyses further examined whether comparative effectiveness was dependent on prerandomization adoption, number of providers trained or practice size. Facilitation log data were used for exploratory follow-up analyses.
DATA COLLECTION


Sites reported monthly on number of patients that had received the CCM. Facilitation logs were completed by study EF and site IFs and shared with the study team.
PRINCIPAL FINDINGS


N = 21 sites were randomized to EF and 22 to EF/IF. Overall, EF/IF practices saw more uptake than EF sites after 12 months (Δ EF/IF-EF   = 4.4 patients, 95% CI = 1.87-6.87). Moderators' analyses, however, revealed that it was only sites with no prerandomization uptake of the CCM (nonadopter sites) that saw significantly more benefit from EF/IF (Δ EF/IF-EF   = 9.2 patients, 95% CI: 5.72, 12.63). For sites with prerandomization uptake (adopter sites), EF/IF offered no additional benefit (Δ EF/IF-EF   = -0.9; 95% CI: -4.40, 2.60). Number of providers trained and practice size were not significant moderators.
CONCLUSIONS


Although stepping up to the more intensive EF/IF did outperform EF overall, its benefit was limited to sites that failed to deliver any CCM under the low-level strategy. Once one or more providers were delivering the CCM, additional on-site personnel did not appear to add value to the implementation effort.",2020,"IF (Δ EF/IF-EF   = 9.2 patients, 95% CI: 5.72, 12.63).","['slow-implementer community practices', 'Primary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12\xa0months following randomization', 'N\xa0=\xa021 sites', 'Sites that failed to meet a pre-established implementation benchmark after six months of low-level implementation support']","['external facilitation (EF) vs external\xa0+\xa0internal facilitation (EF/IF', 'external vs blended facilitation']",[],"[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",[],,0.0757305,"IF (Δ EF/IF-EF   = 9.2 patients, 95% CI: 5.72, 12.63).","[{'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Celeste M', 'Initials': 'CM', 'LastName': 'Liebrecht', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kilbourne', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",Health services research,['10.1111/1475-6773.13583']
2091,33125189,"A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654 in Healthy Adults.","Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infection and related morbidity and mortality in infants. Passive immunization with an RSV-neutralizing antibody can provide rapid protection to this vulnerable population. Proof-of-concept for this approach has been demonstrated by palivizumab; however, the use of this antibody is generally restricted to the highest-risk infants due to monthly dosing requirements and its cost. To address the large unmet medical need for most infants, we are evaluating MK-1654, a fully human RSV-neutralizing antibody with half-life extending mutations targeting site IV of the fusion protein. In this 2-part, placebo-controlled, double-blind, first-in-human study, 152 healthy adults were randomized 3:1 to receive a single dose of MK-1654 or placebo in 5 cohorts (100 or 300 mg as an intramuscular dose or 300, 1000, or 3000 mg as an intravenous dose). Safety, pharmacokinetics, antidrug antibodies, and RSV serum-neutralizing antibody titers were evaluated through 1 year. MK-1654 serum concentrations increased proportionally with dose and resulted in corresponding elevations in RSV serum-neutralizing antibody titers. The antibody displayed a half-life of 73 to 88 days and an estimated bioavailability of 69% at the 300-mg dose. The overall safety profile of MK-1654 was similar to placebo, and treatment-emergent antidrug antibodies were low (2.6%) with no associated adverse events. These data support the continued development of MK-1654 for the prevention of RSV disease in infants.",2020,MK-1654 serum concentrations increased proportionally with dose and resulted in corresponding elevations in RSV serum-neutralizing antibody titers.,"['Healthy Adults', 'infants', '152 healthy adults']","['MK-1654 or placebo', 'palivizumab', 'Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654', 'placebo', 'Placebo']","['MK-1654 serum concentrations', 'Safety, Tolerability, and Pharmacokinetics', 'Safety, pharmacokinetics, antidrug antibodies, and RSV serum-neutralizing antibody titers', 'adverse events', 'overall safety profile of MK-1654', 'estimated bioavailability']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",152.0,0.218162,MK-1654 serum concentrations increased proportionally with dose and resulted in corresponding elevations in RSV serum-neutralizing antibody titers.,"[{'ForeName': 'Antonios O', 'Initials': 'AO', 'LastName': 'Aliprantis', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wolford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Luzelena', 'Initials': 'L', 'LastName': 'Caro', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Maas', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Montgomery', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Sterling', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Cox', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Kalpit A', 'Initials': 'KA', 'LastName': 'Vora', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Brad A', 'Initials': 'BA', 'LastName': 'Roadcap', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Radha A', 'Initials': 'RA', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Eseng', 'Initials': 'E', 'LastName': 'Lai', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.883']
2092,33122694,Safety and efficacy of Melissa officinalis extract containing rosmarinic acid in the prevention of Alzheimer's disease progression.,"We conducted a randomized placebo-controlled double-blind 24-week trial using Melissa officinalis (M. officinalis) extract richly containing rosmarinic acid (RA) on patients with mild dementia due to Alzheimer's disease (AD) with the aim to examine the safety and tolerability (primary endpoint) of RA (500 mg daily) and its clinical effects and disease-related biomarker changes (secondary endpoints). Patients (n = 23) diagnosed with mild dementia due to probable AD were randomized to either the placebo or M. officinalis extract group. No differences in vital signs or physical and neurologic examination results were detected between the M. officinalis and placebo groups. No serious adverse events occurred. There were no significant differences in cognitive measures; however, the mean Neuropsychiatric Inventory Questionnaire (NPI-Q) score improved by 0.5 points in the M. officinalis group and worsened by 0.7 points in the placebo group between the baseline and 24-week visit, indicating a significant difference (P = 0.012). No significant differences were apparent in disease-related biomarkers between the groups. M. officinalis extract containing 500 mg of RA taken daily was safe and well-tolerated by patients with mild dementia due to AD. Our results suggest that RA may help prevent the worsening of AD-related neuropsychiatric symptoms.Trial registration: The registration number for this clinical trial is UMIN000007734 (16/04/2012).",2020,No differences in vital signs or physical and neurologic examination results were detected between the M. officinalis and placebo groups.,"[""Alzheimer's disease progression"", ""patients with mild dementia due to Alzheimer's disease (AD"", 'Patients (n\u2009=\u200923) diagnosed with mild dementia due to probable AD', 'patients with mild dementia due to AD']","['Melissa officinalis extract containing rosmarinic acid', 'M. officinalis extract containing 500\xa0mg of RA', 'RA', 'placebo', 'placebo or M. officinalis extract', 'Melissa officinalis (M. officinalis) extract richly containing rosmarinic acid (RA']","['mean Neuropsychiatric Inventory Questionnaire (NPI-Q) score', 'safety and tolerability', 'safe and well-tolerated', 'disease-related biomarkers', 'cognitive measures', 'vital signs or physical and neurologic examination results']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C3256424', 'cui_str': 'Melissa officinalis extract'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073590', 'cui_str': 'rosmarinic acid'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1008143', 'cui_str': 'Lemon Balm'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.52211,No differences in vital signs or physical and neurologic examination results were detected between the M. officinalis and placebo groups.,"[{'ForeName': 'Moeko', 'Initials': 'M', 'LastName': 'Noguchi-Shinohara', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Ono', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Toshitada', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': 'Department of Food and Life-Science, Takasaki University of Health and Welfare, Gunma, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Research Center for Food Safety, Graduate School of Agricultural and Life Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Komatsu', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Miharu', 'Initials': 'M', 'LastName': 'Samuraki-Yokohama', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Iwasa', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Thyroidology, Public Central Hospital of Matto Ishikawa, Hakusan, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Environmental and Preventive Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan. m-yamada@med.kanazawa-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-020-73729-2']
2093,33122738,Using proximity extension proteomics assay to identify biomarkers associated with infarct size and ejection fraction after ST-elevation myocardial infarction.,"Plasma concentrations of many cardiovascular and inflammatory proteins are altered after ST-elevation myocardial infarction (STEMI) and may provide prognostic information. We conducted a large-scale proteomic analysis in patients with STEMI, correlating protein levels to infarct size and left ventricular ejection fraction (LVEF) determined with cardiac magnetic resonance imaging. We analysed 131 cardiovascular and inflammatory proteins using a multiplex proximity extension assay and blood samples obtained at baseline, 6, 24, and 96 h from the randomised clinical trial CHILL-MI. Cardiac magnetic resonance imaging data at 4 ± 2 days and 6 months were available as per trial protocol. Using a linear regression model with bootstrap resampling and false discovery rate adjustment we identified five proteins (ST2, interleukin-6, pentraxin-3, interleukin-10, renin, and myoglobin) with elevated values corresponding to larger infarct size or worse LVEF and four proteins (TNF-related apoptosis-inducing ligand, TNF-related activation induced cytokine, interleukin-16, and cystatin B) with values inversely related to LVEF and infarct size, concluding that among 131 circulating inflammatory and cardiovascular proteins in the acute and sub-acute phase of STEMI, nine showed a relationship with infarct size and LVEF post-STEMI, with IL-6 and ST2 exhibiting the strongest association.",2020,"Using a linear regression model with bootstrap resampling and false discovery rate adjustment we identified five proteins (ST2, interleukin-6, pentraxin-3, interleukin-10, renin, and myoglobin) with elevated values corresponding to larger infarct size or worse LVEF and four proteins (TNF-related apoptosis-inducing ligand, TNF-related activation induced cytokine, interleukin-16, and cystatin B) with values inversely related to LVEF and infarct size, concluding that among 131 circulating inflammatory and cardiovascular proteins in the acute and sub-acute phase of STEMI, nine showed a relationship with infarct size and LVEF post-STEMI, with IL-6 and ST2 exhibiting the strongest association.","['patients with STEMI, correlating protein levels to infarct size and left ventricular ejection fraction (LVEF) determined with cardiac magnetic resonance imaging']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],[],131.0,0.238972,"Using a linear regression model with bootstrap resampling and false discovery rate adjustment we identified five proteins (ST2, interleukin-6, pentraxin-3, interleukin-10, renin, and myoglobin) with elevated values corresponding to larger infarct size or worse LVEF and four proteins (TNF-related apoptosis-inducing ligand, TNF-related activation induced cytokine, interleukin-16, and cystatin B) with values inversely related to LVEF and infarct size, concluding that among 131 circulating inflammatory and cardiovascular proteins in the acute and sub-acute phase of STEMI, nine showed a relationship with infarct size and LVEF post-STEMI, with IL-6 and ST2 exhibiting the strongest association.","[{'ForeName': 'Moman A', 'Initials': 'MA', 'LastName': 'Mohammad', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Egerstedt', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'J Gustav', 'Initials': 'JG', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'Center for Intensive Internal Medicine, Ljubliana, Slovenia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holzer', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of Cardiology, University Heart and Vascular Center, Hamburg, Germany.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Gidlöf', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Metzler', 'Affiliation': 'Department of Cardiology, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden. david.erlinge@med.lu.se.'}]",Scientific reports,['10.1038/s41598-020-75399-6']
2094,33122773,"The influence of the Kinesio Taping on selected ultrasonography measurements, and quality of life in patients with rotator cuff lesions.","The assessment of the six-week influence of Kinesio Taping combined with a rehabilitation on selected ultrasonography measurements, the level of disability, and the quality of life in patients with rotator cuff lesions. 60 participants were randomly assigned into a taping group (KT combined with a six-week rehabilitating protocol) and a control group (only rehabilitation protocol). In all patients the following assessments were performed twice: USG, UEFI and NHP questionnaires. In the examination of the subacromial space and the subacromial bursa in the taping group, no statistical significance was observed. A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group. A statistically significant change was obtained in the assessment of tendinopathy only for the supraspinatus muscle in both groups. Within both groups a statistically significant difference was observed in the average UEFI and NHP scores; however, the differences in the scores obtained between the groups were not statistically significant. The use of KT with a rehabilitation program did not yield statistically significantly better results in the improvement of selected shoulder region indicators, the function of the upper limb and the quality of life.",2020,A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group.,"['patients with rotator cuff lesions', '60 participants']","['taping group (KT combined with a six-week rehabilitating protocol) and a control group (only rehabilitation protocol', 'Kinesio Taping combined with a rehabilitation', 'Kinesio Taping']","['average UEFI and NHP scores', 'function of the upper limb and the quality of life', 'selected ultrasonography measurements, and quality of life', 'level of disability, and the quality of life', 'thickness of the muscles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",60.0,0.0193926,A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group.,"[{'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Bac', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech University of Physical Education, al. Jana Pawła II 78, 31-571, Kraków, Poland. aneta.bac@awf.krakow.pl.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wróbel', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech University of Physical Education, al. Jana Pawła II 78, 31-571, Kraków, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Ogrodzka-Ciechanowicz', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech University of Physical Education, al. Jana Pawła II 78, 31-571, Kraków, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Michalik', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech University of Physical Education, al. Jana Pawła II 78, 31-571, Kraków, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ścisłowska-Czarnecka', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech University of Physical Education, al. Jana Pawła II 78, 31-571, Kraków, Poland.'}]",Scientific reports,['10.1038/s41598-020-75701-6']
2095,33124987,Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial.,"BACKGROUND


Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (""new friends"") at any time and place, it leads to heightened sexual health risks and privacy concerns.
OBJECTIVE


This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps.
METHODS


An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants' sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney U test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS.
RESULTS


A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (P<.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
CONCLUSIONS


The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-018-3167-5.",2020,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","['Young Adults', 'young adults', '578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up', 'female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students', 'young students', 'Chinese college students', 'students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong', 'Students aged 17 to 27 years who attended common core curriculum or general education']","['peer-led web-based intervention', 'Peer-Led Web-Based Intervention']","['GSE score', 'general self-efficacy', 'RPS score', 'risk reduction', 'risk propensity scale (RPS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0204116', 'cui_str': 'Vocational training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",578.0,0.0906271,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","[{'ForeName': 'William Cw', 'Initials': 'WC', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Wai Han', 'Initials': 'WH', 'LastName': 'Sun', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Shu Ming Cheryl', 'Initials': 'SMC', 'LastName': 'Chia', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill - Project China, Guangzhou, China.'}, {'ForeName': 'William Ph', 'Initials': 'WP', 'LastName': 'Mak', 'Affiliation': 'Vocational Training Council, Hong Kong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Communication, Faculty of Social Sciences, University of Macau, Macau, Macao.'}, {'ForeName': 'Kitty Wai Ying', 'Initials': 'KWY', 'LastName': 'Choi', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Stephanie Tsz Hei', 'Initials': 'STH', 'LastName': 'Lau', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric Yuk Fai', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}]",Journal of medical Internet research,['10.2196/16378']
2096,33124989,"A Mobile App, KhunLook, to Support Thai Parents and Caregivers With Child Health Supervision: Development, Validation, and Acceptability Study.","BACKGROUND


In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH). However, when a new MCHH edition is released, those with the previous editions do not have access to the updated information. A mobile app is an appealing platform to fill this gap. We developed a mobile app called ""KhunLook"" as an interactive electronic MCHH intended to assist parents in child health supervision.
OBJECTIVE


This study describes the user requirements and development of the KhunLook mobile app, validity of parents' growth assessments, and parents' evaluation of feasibility and acceptability of the app.
METHODS


Phase 1 was a qualitative study using individual interviews. The interview data were used to revise the prototype. In phase 2, parents were randomly assigned to assess their children's growth with the app or the MCHH. The outcomes were compared to those of the physician's assessment, and congruence was determined. In phase 3, parents evaluated the feasibility and acceptability of the app in comparison to the MCHH through a web-based survey.
RESULTS


Four health care providers and 8 parents participated in phase 1. Two themes were identified: (1) the mobile app potentially counters parents' infrequent use of the MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs to be standard, up-to-date, and understandable. KhunLook was publicly launched with a family page and 7 key features: growth and nutrition, development, immunizations, oral health, reminders for the next appointment, memories, and health advice. In phase 2, 56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group. The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different. The congruence proportions were higher in the App group for weight and head circumference, but the differences were not statistically significant. In phase 3, 356 parents from all over Thailand participated in a web-based survey. Parents rated the app feasibility as ""very easy to easy"" to use at higher proportions than the MCHH in all health assessment domains (growth, development, and immunizations) and ease-of-use domains with statistical significance (P<.001). The KhunLook app received a significantly higher mean score (8.59/10) than the MCHH (7.6/10) (P<.001). Most parents (317/356, 89.0%) preferred the app over MCHH. Further, 93.5% (333/356) of the parents stated that they would continue to use the app and 96.9% (345/356) would recommend others to use it.
CONCLUSIONS


KhunLook, a Thai mobile app for child health supervision, was developed, validated for growth assessments, and was well accepted for ease-of-use by parents. Further studies should be conducted with a large scale of users, and the impact of this app on health behaviors and health outcomes must be evaluated.",2020,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"['356 parents from all over Thailand participated in a web-based survey', '56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group', 'In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH']",[],"['MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs', 'weight and head circumference', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",356.0,0.0284046,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"[{'ForeName': 'Rosawan', 'Initials': 'R', 'LastName': 'Areemit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pagakrong', 'Initials': 'P', 'LastName': 'Lumbiganon', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chanyut', 'Initials': 'C', 'LastName': 'Suphakunpinyo', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Arunee', 'Initials': 'A', 'LastName': 'Jetsrisuparb', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sumitr', 'Initials': 'S', 'LastName': 'Sutra', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kunwadee', 'Initials': 'K', 'LastName': 'Sripanidkulchai', 'Affiliation': 'Department of Computer Engineering, Faculty of Engineering, Chulalongkorn University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/15116']
2097,33124994,A Web Application About Herd Immunity Using Personalized Avatars: Development Study.,"BACKGROUND


Herd immunity or community immunity refers to the reduced risk of infection among susceptible individuals in a population through the presence and proximity of immune individuals. Recent studies suggest that improving the understanding of community immunity may increase intentions to get vaccinated.
OBJECTIVE


This study aims to design a web application about community immunity and optimize it based on users' cognitive and emotional responses.
METHODS


Our multidisciplinary team developed a web application about community immunity to communicate epidemiological evidence in a personalized way. In our application, people build their own community by creating an avatar representing themselves and 8 other avatars representing people around them, for example, their family or coworkers. The application integrates these avatars in a 2-min visualization showing how different parameters (eg, vaccine coverage, and contact within communities) influence community immunity. We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library). Data included psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging.
RESULTS


Among 110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years. More than half (65/110, 59.0%) of participants reported having a university-level education. Iterative changes across the cycles included adding the ability for users to create their own avatars, specific signals about who was represented by the different avatars, using color and movement to indicate protection or lack of protection from infectious disease, and changes to terminology to ensure clarity for people with varying educational backgrounds. Overall, we observed 3 generalizable findings. First, visualization does indeed appear to be a promising medium for conveying what community immunity is and how it works. Second, by involving multiple users in an iterative design process, it is possible to create a short and simple visualization that clearly conveys a complex topic. Finally, evaluating users' emotional responses during the design process, in addition to their cognitive responses, offers insights that help inform the final design of an intervention.
CONCLUSIONS


Visualization with personalized avatars may help people understand their individual roles in population health. Our app showed promise as a method of communicating the relationship between individual behavior and community health. The next steps will include assessing the effects of the application on risk perception, knowledge, and vaccination intentions in a randomized controlled trial. This study offers a potential road map for designing health communication materials for complex topics such as community immunity.",2020,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","['110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years']",[],"['risk perception, knowledge, and vaccination intentions', ""psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging""]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",110.0,0.0683283,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","[{'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Hakim', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Chambers', 'Affiliation': 'Department of Psychology and Neuroscience and Pediatrics, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'S Michelle', 'Initials': 'SM', 'LastName': 'Driedger', 'Affiliation': 'Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada, Winnipeg, MB, Canada.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Dubé', 'Affiliation': 'Institut national de santé publique du Québec, Institut national de santé publique du Québec, Quebec City, QC, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gavaruzzi', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padova, Italy, Padova, Italy.'}, {'ForeName': 'Anik M C', 'Initials': 'AMC', 'LastName': 'Giguere', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Kavanagh', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leask', 'Affiliation': 'Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'MacDonald', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Orji', 'Affiliation': 'Faculty of Computer Science, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parent', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Paquette', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jacynthe', 'Initials': 'J', 'LastName': 'Roberge', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Sander', 'Affiliation': 'University Health Network, Toronto General Hospital, Eaton Building, Toronto, ON, Canada.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Scherer', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa, IA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tremblay-Breault', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Kumanan', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Bruyere Research Institute and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reinharz', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}]",Journal of medical Internet research,['10.2196/20113']
2098,33124996,"Authors' Reply to: Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0646693,,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, Hong Kong.'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Journal of medical Internet research,['10.2196/24084']
2099,33119477,"Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by  UGT1A1  Status in Patients With Locally Advanced Rectal Cancer.","PURPOSE


Differentiating the irinotecan dose on the basis of the uridine diphosphate glucuronosyltransferase 1A1 ( UGT1A1 ) genotype improves the pathologic complete response (pCR) rate. In this study, we further investigated preoperative irinotecan combined with capecitabine-based chemoradiotherapy for locally advanced rectal cancer.
PATIENTS AND METHODS


We conducted this randomized, open-label, multicenter, phase III trial in China. Eligible patients with clinical T3-4 and/or N+ rectal adenocarcinoma,  UGT1A1  genotype  *1*1  or  *1*28  were randomly allocated to the control group: pelvic radiation of 50 Gy/25 fractions with concurrent capecitabine, followed by oxaliplatin and capecitabine; or the experimental group: radiation with capecitabine combined with weekly irinotecan 80 mg/m 2  for patients with  UGT1A1*1*1  or 65 mg/m 2  for patients with  UGT1A1*1*28 , followed by irinotecan and capecitabine. The primary end point was pCR. This trial was registered with ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT02605265).
RESULTS


Of the 360 patients initially enrolled, 356 were evaluated as the modified intention-to-treat population (n = 178 in both groups). Surgery was performed in 87% and 88% of patients in the control and experimental groups, respectively. The pCR rates were 15% (n = 27 of 178) and 30% (n = 53 of 178) in the control and experimental groups (risk ratio, 1.96; 95% CI, 1.30 to 2.97;  P  = .001). Four and 6 patients achieved complete clinical response in the control and experimental groups, respectively. Grade 3-4 toxicities were recorded in 11 (6%) and 68 (38%) patients in the control and experimental groups, respectively ( P  < .001). The commonest grade 3-4 toxicities were leukopenia, neutropenia, and diarrhea. The overall surgical complication rate was not significantly different between the two groups (11%  v  15%;  P  < .001).
CONCLUSION


Adding irinotecan guided by  UGT1A1  genotype to capecitabine-based neoadjuvant chemoradiotherapy significantly increased complete tumor response in Chinese patients.",2020,"The overall surgical complication rate was not significantly different between the two groups (11%  v  15%;  P  < .001).
","['360 patients initially enrolled, 356 were evaluated as the modified intention-to-treat population (n = 178 in both groups', 'locally advanced rectal cancer', 'Eligible patients with clinical T3-4 and/or N+ rectal adenocarcinoma,  UGT1A1  genotype', '1*1  or  *1*28', 'Patients With Locally Advanced Rectal Cancer', 'Chinese patients']","['irinotecan and capecitabine', 'capecitabine combined with weekly irinotecan 80 mg/m 2  for patients with  UGT1A1', 'capecitabine-based neoadjuvant chemoradiotherapy', 'capecitabine-based chemoradiotherapy', 'control group: pelvic radiation of 50 Gy/25 fractions with concurrent capecitabine, followed by oxaliplatin and capecitabine', 'Capecitabine and Irinotecan']","['pCR', 'Grade 3-4 toxicities', 'complete clinical response', 'commonest grade 3-4 toxicities were leukopenia, neutropenia, and diarrhea', 'pathologic complete response (pCR) rate', 'complete tumor response', 'overall surgical complication rate', 'pCR rates']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",360.0,0.10175,"The overall surgical complication rate was not significantly different between the two groups (11%  v  15%;  P  < .001).
","[{'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Anwen', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xinchen', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital of the University of Chinese Academy of Sciences & Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yaqun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Radiotherapy, Liaoning Cancer Hospital & Institute, China Medical University Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': ""Department of Oncology, Guizhou Provincial People's Hospital, Guiyang, China.""}, {'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Sichuan Cancer Hospital& Institute, Chengdu, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, HWA MEI Hospital, University of Chinese Academy of Science, Ningbo, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Radiation Oncology, Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Juefeng', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'SanJun', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Colorectal Cancer, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01932']
2100,33119491,Efficacy of single-session transcranial direct current stimulation on addiction-related inhibitory control and craving: a randomized trial in males with Internet gaming disorder.,"BACKGROUND


Transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) may reduce substance use and other addictive behaviours. However, the cognitive mechanisms that underpin such effects remain unclear. Impaired inhibitory control linked to hypoactivation of the prefrontal cortex may allow craving-related motivations to lead to compulsive addictive behaviours. However, very few studies have examined whether increasing the activation of the dlPFC via anodal tDCS could enhance inhibitory control over addiction-related distractors. The current study aimed to enrich empirical evidence related to this issue.
METHODS


Thirty-three males with Internet gaming disorder underwent active (1.5 mA for 20 minutes) and sham tDCS 1 week apart, in randomized order. We assessed inhibitory control over gaming-related distractors and craving pre- and post-stimulation.
RESULTS


Relative to sham treatment, active tDCS reduced interference from gaming-related (versus non-gaming) distractors and attenuated background craving, but did not affect cue-induced craving.
LIMITATIONS


This study was limited by its relatively small sample size and the fact that it lacked assessments of tDCS effects on addictive behaviour. Future tDCS studies with multiple sessions in larger samples are warranted to examine the effects on addictive behaviours of alterations in addiction-related inhibitory control.
CONCLUSION


These findings demonstrate that stimulation of the dlPFC influences inhibitory control over addiction-related cues and addiction-related motivation. This is the first empirical study to suggest that enhanced inhibitory control may be a cognitive mechanism underlying the effects of tDCS on addictions like Internet gaming disorder. Our finding of attenuated background craving replicated previous tDCS studies. Intriguingly, our finding of distinct tDCS effects on 2 forms of craving suggests that they may have disparate underlying mechanisms or differential sensitivity to tDCS.
CLINICAL TRIALS NO.


NCT03352973.",2020,"RESULTS


Relative to sham treatment, active tDCS reduced interference from gaming-related (versus non-gaming) distractors and attenuated background craving, but did not affect cue-induced craving.
","['Thirty-three males with Internet gaming disorder underwent active (1.5 mA for 20 minutes) and', 'males with Internet gaming disorder']","['sham tDCS', 'single-session transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS']",['addiction-related inhibitory control and craving'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",33.0,0.0750537,"RESULTS


Relative to sham treatment, active tDCS reduced interference from gaming-related (versus non-gaming) distractors and attenuated background craving, but did not affect cue-induced craving.
","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Wu', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Shi', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Yip', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Jia-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Liu', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': 'From the State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China (Wu, Xu, Shi, Zhu, Wang, Liu, Zhang); the Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA (Potenza, Kober, Yip); the Child Study Center, Yale University School of Medicine, New Haven, CT, USA (Potenza); the Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Council on Problem Gambling, Wethersfield, CT, USA (Potenza); the Connecticut Mental Health Center, New Haven, CT, USA (Potenza); the Faculty of Education, Beijing Normal University, Beijing 100875, China (Zhou); and the Department of Psychology, Yale University School of Medicine, New Haven, CT, USA (Kober).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190137']
2101,33119572,Exploring Pasifika wellbeing: findings from a large cluster randomised controlled trial of a mobile health intervention programme.,"AIM


The primary objective of this study was to determine the effect of a mobile health (mHealth) intervention on the wellbeing of Pasifika peoples, and to explore factors associated with Pasifika wellbeing.
METHODS


The OL@-OR@ mHealth programme was a co-designed smartphone app. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The concept of wellbeing was examined as part of a two-arm, cluster randomised trial, using only the Pasifika data: 389 (of 726) Pasifika adults were randomised to receive the mHealth intervention, while 405 (of 725) Pasifika adults were randomised to receive a control version of the intervention. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The intervention effects and the association of demographic and behavioural relationships with wellbeing, was examined using logistic regression analyses.
RESULTS


Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial. There were no significant differences observed for all other wellbeing domains for both groups. Based on our multivariate regression analyses, education and acculturation (assimilation and marginalisation) were identified as positively strong factors associated to Pasifika 'family and community' wellbeing.
CONCLUSION


Our study provides new insights on how Pasifika peoples' characteristics and behaviours align to wellbeing. Our findings point to 'family and community' as being the most important wellbeing factor for Pasifika peoples.",2020,"RESULTS


Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial.",['Pasifika adults'],"['mobile health (mHealth) intervention', 'mobile health intervention programme', 'mHealth intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0707487,"RESULTS


Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial.","[{'ForeName': 'Ridvan', 'Initials': 'R', 'LastName': 'Firestone', 'Affiliation': 'Senior Research Officer/Co-Principal Investigator, Centre for Public Health Research, Massey University, Wellington.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Biostatistician, Centre for Public Health Research, Massey University, Wellington.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Dalhousie', 'Affiliation': 'Community Partner, The Fono, Auckland.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Community Coordinator, The Fono, Auckland.'}, {'ForeName': 'Tevita', 'Initials': 'T', 'LastName': 'Funaki', 'Affiliation': 'Chief Executive, Community Partner, The Fono, Auckland.'}, {'ForeName': 'Akarere', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': 'Chief Executive, Community Partner, South Waikato Pacific Islands Community Services, Tokoroa.'}, {'ForeName': 'Mereaumate', 'Initials': 'M', 'LastName': 'Vano', 'Affiliation': 'Community Coordinator, South Waikato Pacific Islands Community Services, Tokoroa.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Grey', 'Affiliation': 'Project Manager, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': 'Project Coordinator, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jull', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland; School of Nursing, University of Auckland, Auckland.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'Associate Professor, School of Nursing, University of Auckland, Auckland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Te Morenga', 'Affiliation': 'Senior Lecturer/Co-Principal Investigator, School of Health, Faculty of Health, Victoria University of Wellington, Wellington.'}, {'ForeName': 'Cliona Ni', 'Initials': 'CN', 'LastName': 'Mhurchu', 'Affiliation': 'Professor/Co-Principal Investigator, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}]",The New Zealand medical journal,[]
2102,33119613,"Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.","BACKGROUND


Rintatolimod is a selective TLR3 agonist, which has demonstrated clinical activity for ME/CFS in Phase II and Phase III double-blind, placebo-controlled, randomized, multi-site clinical trials.
METHODS AND FINDINGS


A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial was performed to evaluate the effect of rintatolimod therapy based on disease duration. The clinical activity of rintatolimod was evaluated by exercise treadmill tolerance (ETT) using a modified Bruce protocol. The ITT population (n = 208) was divided into two subsets of symptom duration. Patients with symptom duration of 2-8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133). Placebo-adjusted percentage improvements in exercise duration and the vertical rise for the Target Subset (n = 75) were more than twice that of the ITT population. The Non-Target Subset (n = 133) failed to show any clinically significant ETT response to rintatolimod when compared to placebo. Within the Target Subset, 51.2% of rintatolimod-treated patients improved their exercise duration by ≥25% (p = 0.003) despite reduced statistical power from division of the original ITT population into two subsets.
CONCLUSION/SIGNIFICANCE


Analysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%. This magnitude of exercise improvement was associated with clinically significant enhancements in quality of life. The data indicate that ME/CFS patients have a relatively short disease duration window (<8 years) to expect a significant response to rintatolimod under the dosing conditions utilized in this Phase III clinical trial. These results may have direct relevance to the cognitive impairment and fatigue being experienced by patients clinically recovered from COVID-19 and free of detectable SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00215800.",2020,Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%.,"['A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome', 'Patients with symptom duration of 2-8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133']","['rintatolimod therapy', 'rintatolimod', 'placebo', 'Placebo']","['exercise duration', 'exercise duration and the vertical rise', 'quality of life', 'physical performance']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C1434913', 'cui_str': 'rintatolimod'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",75.0,0.0896146,Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strayer', 'Affiliation': 'AIM ImmunoTech Inc., Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'AIM ImmunoTech Inc., Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Mitchell', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.'}]",PloS one,['10.1371/journal.pone.0240403']
2103,33119658,"An exercise-based educational and motivational intervention after surgery can improve behaviors, physical fitness and quality of life in bariatric patients.","INTRODUCTION


Unhealthy lifestyles may hinder bariatric surgery outcomes. This non-randomized controlled study aimed to evaluate the effects of an integrated post-operative exercise-based educational and motivational program in improving behaviors, quality of life, anthropometric features, cardiorespiratory and physical fitness in bariatric patients respect to the only surgical intervention.
METHODS


A group of adult sedentary bariatric patients chose to attend a 12-month exercise program integrated with diet education and motivational support, or to receive usual care. Dietary habits, binge eating disorder, physical activity, obesity-related quality of life, Body Mass Index, waist and hip circumference, VO2max, strength and flexibility were assessed at the start and at the end of the study in both groups.
RESULTS


On a total of 82 patients enrolled, follow-up measures were obtained from 28 (85.7% females, mean age 38.2±8.7) and 42 (71.4% females, mean age 40.2±9.5) patients included in the intervention and control group, respectively. All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
CONCLUSIONS


Notwithstanding the self-selection, these results suggest that a timely postoperative behavioral multidisciplinary program for bariatric patients may be effective in establishing healthy behaviors which can lead to better surgery outcomes.",2020,"All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
","['82 patients enrolled, follow-up measures were obtained from 28 (85.7% females, mean age 38.2±8.7) and 42 (71.4% females, mean age 40.2±9.5', 'bariatric patients', 'bariatric patients respect to the only surgical intervention', 'A group of adult sedentary bariatric patients']","['exercise-based educational and motivational intervention', 'exercise program integrated with diet education and motivational support, or to receive usual care', 'integrated post-operative exercise-based educational and motivational program']","['Dietary habits, binge eating disorder, physical activity, obesity-related quality of life, Body Mass Index, waist and hip circumference, VO2max, strength and flexibility', 'behavioral and physical outcomes', 'quality of life and physical fitness', 'behaviors, quality of life, anthropometric features, cardiorespiratory and physical fitness', 'behaviors, physical fitness and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",82.0,0.0258224,"All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gallé', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Gianpaolo', 'Initials': 'G', 'LastName': 'Marte', 'Affiliation': 'Evangelical Hospital ""Villa Betania"", Naples, Italy.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Cirella', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Di Dio', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Miele', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ricchiuti', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Liguori', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Maida', 'Affiliation': 'Evangelical Hospital ""Villa Betania"", Naples, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Liguori', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}]",PloS one,['10.1371/journal.pone.0241336']
2104,33119948,"Effects of potato resistant starch intake on insulin sensitivity, related metabolic markers and appetite ratings in men and women at risk for type 2 diabetes: a pilot cross-over randomised controlled trial.","BACKGROUND


The intake of certain types of resistant starch (RS) has been associated in some studies with increased whole-body insulin sensitivity. This randomised, cross-over pilot trial evaluated the effect of consuming cooked, then chilled potatoes, a source of RS, compared to isoenergetic, carbohydrate (CHO)-containing control foods, on insulin sensitivity and related markers.
METHODS


Nineteen adults with body mass index 27.0-39.9 kg m -2  consumed 300 g day -1  RS-enriched potatoes (approximately two potatoes; ~18 g RS) or CHO-based control foods, as part of lunch, evening and snack meals, over a 24-h period. After an overnight fast, insulin sensitivity, CHO metabolism markers, free fatty acids, breath hydrogen levels and appetite were assessed for up to 5 h after the intake of a standard breakfast. The primary endpoint was insulin sensitivity, assessed with the Matsuda index. P < 0.05 (one-sided) was considered statistically significant.
RESULTS


Insulin sensitivity was not significantly different between the potato and control conditions. The potato intervention resulted in higher postprandial breath hydrogen (P = 0.037), lower postprandial free fatty acid concentrations (P = 0.039) and lower fasting plasma glucose (P = 0.043) compared to the control condition. Fullness ratings were significantly lower after potato versus control (P = 0.002). No other significant effects were observed; however, there was a trend toward lower fasting insulin (P = 0.077) in the potato versus the control condition.
CONCLUSIONS


The results of this pilot study suggest RS-enriched potatoes may have a favourable impact on carbohydrate metabolism and support the view that additional research in a larger study sample is warranted.",2020,"The potato intervention resulted in higher postprandial breath hydrogen (P = 0.037), lower postprandial free fatty acid concentrations (P = 0.039) and lower fasting plasma glucose (P = 0.043) compared to the control condition.","['men and women at risk for type 2 diabetes', 'Nineteen adults with body mass index']","['resistant starch (RS', 'potato resistant starch intake']","['lower postprandial free fatty acid concentrations', 'insulin sensitivity, related metabolic markers and appetite ratings', 'higher postprandial breath hydrogen', 'insulin sensitivity, assessed with the Matsuda index', 'lower fasting insulin', 'Insulin sensitivity', 'fasting plasma glucose', 'Fullness ratings', 'insulin sensitivity, CHO metabolism markers, free fatty acids, breath hydrogen levels and appetite']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",19.0,0.0956767,"The potato intervention resulted in higher postprandial breath hydrogen (P = 0.037), lower postprandial free fatty acid concentrations (P = 0.039) and lower fasting plasma glucose (P = 0.043) compared to the control condition.","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'Midwest Biomedical Research: Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research: Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research: Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research: Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research: Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12822']
2105,33119991,A supervised exercise intervention fails to improve subjective and objective sleep measures among older adults with and without HIV.,"BACKGROUND


Chronic sleep disruption can have significant negative health effects and prior studies suggest that people with HIV (PWH) have disproportionately higher rates of sleep problems.
METHODS


We evaluated baseline sleep of sedentary, older adults (50-75 years) with ( n  = 28) and without HIV ( n  = 29) recruited into a 24-week exercise study. Subjective sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI); objective sleep parameters were assessed using wrist-worn actigraphy. Regression models were used to investigate changes in outcomes.
RESULTS


Fifty-seven participants completed the intervention. At baseline, PWH had significantly lower sleep efficiency (88.7 [95% CI 86, 91]%) compared to controls (91.8 [95% CI 91, 93]%;  p  = 0.02); other sleep measures indicated poorer sleep among PWH but did not reach statistical significance ( p  ≥ 0.12). Overall, sleep outcomes did not significantly change with the exercise intervention (all  p  > 0.05). In adjusted analyses, PWH demonstrated a decrease in total sleep time (-22.1 [-43.7, -0.05]  p  = 0.045) and sleep efficiency (-1.3 [-2.5, -.01],  p  = 0.03) during the 24 weeks of exercise; these differences were attenuated and no longer significant after adjusting for exercise intensity. At the completion of the intervention, compared to controls, PWH had significantly poorer sleep by PSQI score (2.2 [0.6, 3.8];  p  = 0.006) and sleep efficiency (-2.8 [-5.4,-0.2]%;  p  = 0.04).
CONCLUSIONS


In this study, sleep disturbance was more prevalent in sedentary older PWH compared to uninfected controls. An exercise intervention had minimal effect on sleep impairments among PWH nor controls. Among older adults, interventions beyond cardiovascular and resistance exercise may be needed to significantly alter subjective and objective sleep outcomes.",2020,"Overall, sleep outcomes did not significantly change with the exercise intervention (all  p  > 0.05).","['older adults', 'older adults with and without HIV', 'sedentary, older adults (50-75\u2009years) with ( n \u2009=\u200928) and without HIV ( n \u2009=\u200929) recruited into a 24-week exercise study', 'Fifty-seven participants completed the intervention', 'people with HIV (PWH']","['exercise intervention', 'supervised exercise intervention']","['sleep efficiency', 'Pittsburgh Sleep Quality Index (PSQI); objective sleep parameters', 'sleep impairments', 'subjective and objective sleep measures', 'poorer sleep by PSQI score', 'sleep disturbance', 'Overall, sleep outcomes', 'Subjective sleep quality', 'total sleep time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",57.0,0.033687,"Overall, sleep outcomes did not significantly change with the exercise intervention (all  p  > 0.05).","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hixon', 'Affiliation': 'University of Colorado, Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'College of Nursing, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}]",HIV research & clinical practice,['10.1080/25787489.2020.1839708']
2106,33120137,Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial.,"BACKGROUND


Intimate partner violence constitutes a serious health problem worldwide. To date the evidence is sparse on whether intimate partner violence group interventions could improve mental health outcomes among perpetrators and their partners.
OBJECTIVES


To compare the effectiveness of nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy in improving reported mental health outcomes and emotion regulation at 12 months' follow-up amongst perpetrators who voluntarily seek help for violence in intimate partnerships.
DESIGN


A randomised controlled trial.
PARTICIPANTS


A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study.
METHODS


The participants were randomly assigned to cognitive-behavioural group therapy (intervention group, N = 67) or mindfulness-based stress reduction group therapy (comparator group, N = 58). The pre-defined outcomes were symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale at 12 months' follow-up.
RESULTS


A reduction of symptoms of anxiety and depression was reported, with no between-group differences (intervention group: coefficient: - 0.17, P = 0.009; comparator group: coefficient: - 0.13, P = 0.036). Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0. 34, P = <0.001).
CONCLUSION


Even though there was reduction in symptoms in both groups at 12 months' follow-up with no between-group differences, the total symptom scores remained high in both groups.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01653860.",2020,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","['A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study', 'men who perpetrate intimate partner violence']","['nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy', 'cognitive behavioural therapy or mindfulness-based therapy', 'cognitive-behavioural group therapy (intervention group, N\xa0=\xa067) or mindfulness-based stress reduction group therapy (comparator group, N\xa0=\xa058']","['symptoms of anxiety and depression', 'mental health outcomes', 'symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale', 'mental health and emotion regulation', 'reduction in symptoms', 'Difficulties in Emotion Regulation Scale scores', 'total symptom scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",125.0,0.0825749,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","[{'ForeName': 'Merete Berg', 'Initials': 'MB', 'LastName': 'Nesset', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: merete.b.nesset@ntnu.no.""}, {'ForeName': 'Johan Håkon', 'Initials': 'JH', 'LastName': 'Bjørngaard', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Social Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Johan.H.Bjorngaard@ntnu.no.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whittington', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Richard.Whittington@ntnu.no.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Palmstierna', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Tom.Palmstierna@ki.se.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103795']
2107,33120195,"Effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma.","BACKGROUND


Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases.
OBJECTIVE


To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy.
METHODS


A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists.
RESULTS


A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.",2020,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","['242 consecutive subjects (167 intervention, 75 control) were enrolled', '34 community pharmacies in Italy (23 intervention, 11 control', 'patients with asthma on long-term inhalation therapy', 'patients with asthma']","['educational intervention administered by clinical pharmacists (CPs', 'educational intervention']","['disease control', 'TAI score, ACT and lung function parameters', 'adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]",34.0,0.0251079,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paoletti', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Keber', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy. Electronic address: enrico.heffler@hunimed.eu.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Malipiero', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baiardini', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Giua', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine,['10.1016/j.rmed.2020.106199']
2108,33123354,Pelacarsen for lowering lipoprotein(a): implications for patients with chronic kidney disease.,"Chronic kidney disease (CKD) patients are at an increased risk of cardiovascular disease (CVD) and statins may not be protective in advanced CKD. The reasons for the limited efficacy of statins in advanced CKD are unclear, but statins may increase plasma levels of the highly atherogenic molecule lipoprotein(a), also termed Lp(a), as well as PCSK9 (protein convertase subtilisin/kexin type 9) levels. Lp(a) has also been linked to calcific aortic stenosis, which is common in CKD. Moreover, circulating Lp(a) levels increase in nephrotic syndrome with declining renal function and are highest in patients on peritoneal dialysis. Thus, the recent publication of the Phase 2 randomized controlled trial of pelacarsen [also termed AKCEA-APO(a)-LRx and TQJ230], a hepatocyte-directed antisense oligonucleotide targeting the  LPA  gene messenger RNA, in persons with CVD should be good news for nephrologists. Pelacarsen safely and dose-dependently decreased Lp(a) levels by 35-80% and a Phase 3 trial [Lp(a)HORIZON, NCT04023552] is planned to run from 2020 to 2024. Unfortunately, patients with estimated glomerular filtration rate <60 mL/min or urinary albumin:creatinine ratio >100 mg/g were excluded from Phase 2 trials and those with 'significant kidney disease' will be excluded from the Phase 3 trial. Optimized exclusion criteria for Lp(a)HORIZON would provide insights into the role of Lp(a) in CVD in CKD patients.",2020,"Pelacarsen safely and dose-dependently decreased Lp(a) levels by 35-80% and a Phase 3 trial [Lp(a)HORIZON, NCT04023552] is planned to run from 2020 to 2024.","['Chronic kidney disease (CKD) patients', 'patients with chronic kidney disease', ""patients with estimated glomerular filtration rate <60\u2009mL/min or urinary albumin:creatinine ratio >100\u2009mg/g were excluded from Phase 2 trials and those with 'significant kidney disease' will be excluded from the Phase 3 trial""]","['pelacarsen [also termed AKCEA-APO(a)-LRx and TQJ230', 'Pelacarsen']",['Lp(a) levels'],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0356985,"Pelacarsen safely and dose-dependently decreased Lp(a) levels by 35-80% and a Phase 3 trial [Lp(a)HORIZON, NCT04023552] is planned to run from 2020 to 2024.","[{'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Fernandez-Prado', 'Affiliation': 'IIS-Fundacion Jimenez Diaz-Universidad Autonoma de Madrid and Fundacion Renal Iñigo Alvarez de Toledo-IRSIN, Madrid, Spain.'}, {'ForeName': 'Maria Vanessa', 'Initials': 'MV', 'LastName': 'Perez-Gomez', 'Affiliation': 'IIS-Fundacion Jimenez Diaz-Universidad Autonoma de Madrid and Fundacion Renal Iñigo Alvarez de Toledo-IRSIN, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'IIS-Fundacion Jimenez Diaz-Universidad Autonoma de Madrid and Fundacion Renal Iñigo Alvarez de Toledo-IRSIN, Madrid, Spain.'}]",Clinical kidney journal,['10.1093/ckj/sfaa001']
2109,33123362,Home run-results of a chronic kidney disease Telemedicine Patient Education Study.,"Background


Chronic kidney disease (CKD) incidence is increasing and associated mortality and morbidity are high. Educating patients is effective in delaying progression and establishing optimal renal replacement therapy (RRT). Tele-education/telemedicine (TM) can be an effective tool to provide such education, but there are no available data quantifying its effectiveness. We attempted to establish such evidence correlating the effect of education in patient choices and with the start of actual RRT. We present results from a 3-year pilot study evaluating the effectiveness of comprehensive predialysis education (CPE) through TM for CKD patients compared with a standard care group [face to face (FTF)]. The patient's ability to choose RRT was the primary endpoint.
Methods


This was a randomized controlled study providing CPE over three classes at nine sites (one FTF and eight TM). Three assessment tools were utilized to compare groups: CKD knowledge, literacy and quality of life.
Results


A total of 47.1% of FTF and 52.2% of TM patients reported not having enough information to choose a modality. This decreased by the third visit (FTF 7.4%, TM 13.2%). Home modality choices more than doubled in both groups (FTF 25.8-67.7%, TM 22.2-50.1%). In patients that completed one visit and needed to start RRT, 47% started on a home modality or received a pre-emptive transplant (home hemodialysis 6%, peritoneal dialysis 38%, transplant 3%).
Conclusions


Results show almost 90% (TM 87%, FTF 95%) of the attendees could choose a modality after education. Home modality choices doubled. Patients were able to make an informed choice regardless of the modality of education.",2020,"Home modality choices more than doubled in both groups (FTF 25.8-67.7%, TM 22.2-50.1%).",[],"['comprehensive predialysis education (CPE', 'Tele-education/telemedicine (TM', 'CPE', 'FTF']","['CKD knowledge, literacy and quality of life']",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0497972,"Home modality choices more than doubled in both groups (FTF 25.8-67.7%, TM 22.2-50.1%).","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Easom', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Ashutosh M', 'Initials': 'AM', 'LastName': 'Shukla', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Dumitru', 'Initials': 'D', 'LastName': 'Rotaru', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Mercy Clinic Fort Smith, Fort Smith, AR, USA.'}, {'ForeName': 'Songthip', 'Initials': 'S', 'LastName': 'Ounpraseuth', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Sudhir V', 'Initials': 'SV', 'LastName': 'Shah', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Arthur', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]",Clinical kidney journal,['10.1093/ckj/sfz096']
2110,33123379,"Effect of Eating Glutinous Brown Rice Twice a Day for 6 Weeks on Serum 1,5-Anhydroglucitol in Japanese Subjects without Diabetes.","We have previously demonstrated that eating glutinous brown rice (GBR) for 1 day or 8 weeks was well accepted and improved glycemic control in patients with type 2 diabetes. The present study evaluated whether eating GBR could also improve glucose metabolism in subjects without diabetes. A prospective 6-week, single-center, randomized, open-label, parallel-group study was carried out in subjects receiving annual medical checkup at our hospital. A total of 42 subjects were randomly assigned to continue their regular diet (RD group) or to switch GBR twice a day (GBR group). The primary outcome was the change in the serum concentration of 1,5-anhydroglucitol (1,5-AG) from baseline after the 6-week dietary intervention. One subject was excluded from the analysis because of a traffic accident. After 6 weeks, the serum 1,5-AG was significantly increased in the GBR group and the mean treatment difference (GBR group - RD group) was 1.1  µ g/mL (95% CI: 0.6 to 1.6,  p =0.022). Body mass index decreased significantly in both groups, with no significant difference between them ( p =0.210). There were no changes in fasting plasma glucose, fasting insulin, or eating behavior. Intake of GBR for 6 weeks significantly increased serum 1,5-AG in Japanese subjects without diabetes. The increase of 1,5-AG may have been due to the alleviation of postprandial hyperglycemia, which could be effective for the primary prevention of diabetes.",2020,"After 6 weeks, the serum 1,5-AG was significantly increased in the GBR group and the mean treatment difference (GBR group - RD group) was 1.1  µ g/mL","['Japanese Subjects without Diabetes', 'patients with type 2 diabetes', '42 subjects', 'subjects without diabetes', 'subjects receiving annual medical checkup at our hospital', 'Japanese subjects without diabetes']","['continue their regular diet (RD group) or to switch GBR', 'Eating Glutinous Brown Rice']","['serum concentration of 1,5-anhydroglucitol (1,5-AG', 'fasting plasma glucose, fasting insulin, or eating behavior', 'Serum 1,5-Anhydroglucitol', 'serum 1,5-AG', 'glucose metabolism', 'Body mass index', 'glycemic control']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452710', 'cui_str': 'Brown rice'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0044029', 'cui_str': '1,5-anhydrosorbitol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",42.0,0.0197939,"After 6 weeks, the serum 1,5-AG was significantly increased in the GBR group and the mean treatment difference (GBR group - RD group) was 1.1  µ g/mL","[{'ForeName': 'Taiga', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Yasunaka', 'Affiliation': 'Department of Internal Medicine, Sakawa Municipal Kohoku Hospital, Takaoka-Gun, Kochi, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Uraguchi', 'Affiliation': 'Department of Internal Medicine, Sakawa Municipal Kohoku Hospital, Takaoka-Gun, Kochi, Japan.'}, {'ForeName': 'Yukihisa', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Internal Medicine, Sakawa Municipal Kohoku Hospital, Takaoka-Gun, Kochi, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}]",Journal of nutrition and metabolism,['10.1155/2020/8847781']
2111,33123425,Kuntscher Nail: A Forgotten Entity Yet a Reliable Modality in Treatment of Winquist Type I and II Closed Femoral Shaft Fractures.,"Background Interlocking intramedullary nail is used for almost all types of femoral shaft fractures worldwide because of its better mechanical stability. In countries like India with limited healthcare infrastructure, the use of Kuntscher nail (K-nail) in Winquist type I and type II isthmic fractures is still debated. Therefore, we conducted this study to compare the functional outcome, radiation exposure, and cost of the implant between closed reduction and internal fixation of Winquist type I and II fractures in the middle one-third shaft region by K-nail and intramedullary locked nails (IMILN), respectively. Methods This was a hospital-based non-blinded randomized trial which included 56 patients with closed Winquist type I and II femoral shaft fractures of the middle one-third   femoral shaft (isthmic and paraisthmic zone). All the patients were either treated by K-nail or IMILN. The patients were followed up every three weeks for the initial six months and quarterly thereafter. Per operative duration of surgery and radiation exposure by C-arm was documented and assuming scattered radiation 20%, radiation exposure to the surgeon was calculated and patients were assessed clinically and radiologically for union. Results The patients were divided into two groups: group I (K-nail, n = 25) and group II (IMILN, n = 31). In groups I and II, the patients achieving radiological union were 88% (n = 22/25) and 84% (n = 27/31) at six months' duration, respectively. The mean duration for the radiological union was 3.65 ± 0.55 months in group I (K-nail) and 3.76 ± 0.59 months in group II (IMILN), respectively. There was no statistically significant difference in the duration of the union (p = 0.4963). The average number of C- arm exposures was 16.36 ± 3.18 in group I as compared to 27.29 ± 4.01 in group II, and the mean scattered radiation was 5.0 ± 1.63 in group I and 6.61 ± 4.06 in group II. This difference was statistically significant. Conclusion Kuntscher intramedullary nailing can provide comparable rates of union as is achieved with interlocking intramedullary nailing with an advantage of less radiation exposure and duration of surgery, provided the patient selection is proper (isthmic and paraisthmic zone).",2020,There was no statistically significant difference in the duration of the union (p = 0.4963).,"['56 patients with closed Winquist type I and II femoral shaft fractures of the middle one-third \xa0 femoral shaft\xa0(isthmic and paraisthmic zone', 'Kuntscher Nail']","['K-nail or IMILN', 'interlocking intramedullary nailing', 'Kuntscher intramedullary nailing', 'K-nail and intramedullary locked nails (IMILN', ' Interlocking intramedullary nail']","['mean duration for the radiological union', 'duration of the union', 'average number of C- arm exposures', 'radiological union']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0272753', 'cui_str': 'Fracture of shaft of femur'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0588193', 'cui_str': 'Bone structure of shaft of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",56.0,0.0264314,There was no statistically significant difference in the duration of the union (p = 0.4963).,"[{'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Bharti', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, Gorakhpur, IND.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopedics, Ganesh Shankar Vidyarthi Memorial Medical College, Kanpur, IND.'}, {'ForeName': 'Sudhir Shyam', 'Initials': 'SS', 'LastName': 'Kushwaha', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, Gorakhpur, IND.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Orthopedics, Government Medical College Azamgarh, Azamgarh, IND.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, Gorakhpur, IND.'}, {'ForeName': 'Atil K', 'Initials': 'AK', 'LastName': 'Lal', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, Gorakhpur, IND.'}]",Cureus,['10.7759/cureus.10608']
2112,33123444,Application of Henna as a Durable Skin Marker in Orthopedic Surgery.,"Background Many orthopedic procedures require skin marking well before surgery. Marks made with most conventional marking pens fade with vigorous skin preparation required before orthopedic procedures, whereas marks with henna may safely last almost up to three weeks. Thereby, we intend to describe applications of henna, a readily available, cost-effective material, as a durable skin marker for various indications in orthopedics. Methods A total of 120 patients with varied indications for skin marking were randomized into two equal-sized groups of 60 each. Group A patients were marked with henna and group B patients with a permanent skin marker before the intended surgery. All patients had a routine pre-operative bath one day before surgery and vigorous skin preparation using chlorhexidine and ethanol-based scrubs just before surgery in the operating room. The two markers were compared for the following variables: photographic record to determine fading of the mark after scrubbing, in terms of successful execution of the procedure, patients' acceptability of the mark, any allergy or infection, and final time of disappearance of the mark. Results Marking with henna was clearly visible during all but one surgical procedure even after vigorous pre-operative skin preparation, thereby ensuring minimal use of fluoroscopy in henna-marked patients. The fading of the mark and use of fluoroscopy was significantly low in group A (p<0.05). There was no complication associated with marking with either marking method. Marks with henna disappeared on an average nine days later than with permanent marker. In terms of acceptability of mark, henna was preferred by almost all patients. Conclusions Henna paste is an ideal substance for use as a skin marker in conditions, such as foreign body removal, vertebral level identification, nail dynamization, marking tibial physis in children, and sequestrum in non-discharging osteomyelitis, and in marking blood vessel course in tumor surgery or in volar ganglion removal. Pre-operative skin marking with henna ensures minimal use of fluoroscopy, and it is particularly efficacious when ultrasound is used for localization as it can be directly applied over gel film.",2020,The fading of the mark and use of fluoroscopy was significantly low in group A (p<0.05).,"['Orthopedic Surgery', 'All patients had a routine pre-operative bath one day before surgery and vigorous skin preparation using', '120 patients with varied indications for skin marking']",['chlorhexidine and ethanol-based scrubs just before surgery in the operating room'],['fading of the mark and use of fluoroscopy'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0522501', 'cui_str': 'Massive'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",120.0,0.0215451,The fading of the mark and use of fluoroscopy was significantly low in group A (p<0.05).,"[{'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Mohindra', 'Affiliation': 'Orthopaedics, Central Institute of Orthopaedics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, IND.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Meena', 'Affiliation': 'Orthopaedics, Central Institute of Orthopaedics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, IND.'}]",Cureus,['10.7759/cureus.10631']
2113,33123718,A randomized controlled trial comparing controlled reoxygenation and standard cardiopulmonary bypass in paediatric cardiac surgery.,"OBJECTIVES


Controlled reoxygenation on starting cardiopulmonary bypass (CPB) rather than hyperoxic CPB may confer clinical advantages during surgery for congenital cyanotic heart disease.
METHODS


A single-centre, randomized controlled trial was carried out to compare the effectiveness of controlled reoxygenation (normoxia) versus hyperoxic CPB in children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2). The co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay. Analysis of the primary outcomes included data from a previous trial (Oxic-1) conducted to the same protocol.
RESULTS


Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial. There were no significant differences between the groups for any of the co-primary outcomes: inotrope duration geometric mean ratio (normoxia/hyperoxic) 0.97, 95% confidence interval (CI) (0.69-1.37), P-value = 0.87; intubation time hazard ratio (HR) 1.03, 95% CI (0.74-1.42), P-value = 0.87; postoperative ICU stay HR 1.14 95% CI (0.77-1.67), P-value = 0.52, hospital stay HR 0.90, 95% CI (0.65-1.25), P-value = 0.53. Lower oxygen levels were successfully achieved during the operative period in the normoxic group. Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5. Childhood developmental outcomes were similar. In the year following surgery, 85 serious adverse events were reported (51 normoxic group and 34 hyperoxic group).
CONCLUSIONS


Controlled reoxygenation (normoxic) CPB is safe but with no evidence of a clinical advantage over hyperoxic CPB.
CLINICAL TRIAL REGISTRATION NUMBER


Current Controlled Trials-ISRCTN81773762.",2020,"Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5.","['children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2', 'Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial', 'paediatric cardiac surgery']","['Controlled reoxygenation (normoxic) CPB', 'hyperoxic CPB', 'controlled reoxygenation and standard cardiopulmonary bypass', 'controlled reoxygenation (normoxia) versus hyperoxic CPB']","['duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay', 'Serum creatinine levels', 'inotrope duration geometric mean ratio (normoxia/hyperoxic', 'Lower oxygen levels', 'postoperative ICU stay HR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C1394290', 'cui_str': 'Cyanotic heart disease'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.265704,"Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5.","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': ''}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Toity', 'Initials': 'T', 'LastName': 'Deave', 'Affiliation': 'Department of Cardiac Surgery, Centre for Health and Clinical Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dabner', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Department of Cardiac Surgery, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa318']
2114,33123720,Clinical benefits of a swallowing intervention for esophageal cancer patients after esophagectomy.,"Dysphagia after esophagectomy is the main cause of a prolonged postoperative stay. The present study investigated the effects of a swallowing intervention led by a speech-language-hearing therapist (SLHT) on postoperative dysphagia. We enrolled 276 consecutive esophageal cancer patients who underwent esophagectomy and cervical esophagogastric anastomosis between July 2015 and December 2018; 109 received standard care (control group) and 167 were treated by a swallowing intervention (intervention group). In the intervention group, swallowing function screening and rehabilitation based on each patient's dysfunction were led by SLHT. The start of oral intake, length of oral intake rehabilitation, and length of the postoperative stay were compared in the two groups. The patient's subgroups in the 276 patients were examined to clarify the more effectiveness of the intervention. The start of oral intake was significantly earlier in the intervention group (POD: 11 vs. 8 days; P = 0.009). In the subgroup analysis, the length of the postoperative stay was also significantly shortened by the swallowing intervention in patients without complications (POD: 18 vs. 14 days; P = 0.001) and with recurrent laryngeal nerve paralysis (RLNP) (POD: 30 vs. 21.5 days; P = 0.003). A multivariate regression analysis identified the swallowing intervention as a significant independent factor for the earlier start of oral intake and a shorter postoperative stay in patients without complications and with RLNP. Our proposed swallowing intervention is beneficial for the earlier start of oral intake and discharge after esophagectomy, particularly in patients without complications and with RLNP. This program may contribute to enhanced recovery after surgery.",2020,"In the subgroup analysis, the length of the postoperative stay was also significantly shortened by the swallowing intervention in patients without complications (POD: 18 vs. 14 days; P = 0.001) and with recurrent laryngeal nerve paralysis (RLNP) (POD: 30 vs. 21.5 days; P = 0.003).","['esophageal cancer patients after esophagectomy', ""patient's subgroups in the 276 patients"", 'patients without complications and with RLNP', '276 consecutive esophageal cancer patients who underwent esophagectomy and cervical esophagogastric anastomosis between July 2015 and December 2018; 109 received']","['swallowing intervention', 'standard care (control group) and 167 were treated by a swallowing intervention (intervention group', 'swallowing intervention led by a speech-language-hearing therapist (SLHT']","['recurrent laryngeal nerve paralysis (RLNP', 'length of the postoperative stay', 'oral intake, length of oral intake rehabilitation, and length of the postoperative stay', 'Dysphagia', 'postoperative dysphagia', 'swallowing function screening and rehabilitation']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0589274', 'cui_str': 'Swallowing promotion therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",276.0,0.0173416,"In the subgroup analysis, the length of the postoperative stay was also significantly shortened by the swallowing intervention in patients without complications (POD: 18 vs. 14 days; P = 0.001) and with recurrent laryngeal nerve paralysis (RLNP) (POD: 30 vs. 21.5 days; P = 0.003).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takatsu', 'Affiliation': 'Department of Rehabilitation, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higaki', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Rehabilitation, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Speech Pathology, Aichi-Gakuin University,Nisshin, 470-0195, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doaa094']
2115,33123739,The Area of Pressure-Induced Referred Pain Is Dependent on the Intensity of the Suprathreshold Stimulus: An Explorative Study.,"OBJECTIVE


To investigate the pain referral area (number of pixels) and extent (vector length) as elicited from increasing intensities of pressure-induced pain at the shoulder.
DESIGN


Cross-sectional design.
SETTING


Clinical laboratory setting.
PARTICIPANTS


Twenty-two healthy men and women participated in two experimental sessions.
METHODS


Delayed onset of muscle soreness (DOMS) was induced in the dominant shoulder and assessed 24 hours later. Participants rated the level of DOMS on a 6-point Likert scale. Four different intensities (pressure pain threshold [PPT]+20%, PPT+30%, PPT+40%, and PPT+50%) were applied to the infraspinatus in a randomized, balanced fashion for 60 seconds from low to high intensity or vice versa. The resulting location, area, and extent of referred pain as drawn by the participants on a digital body chart were extracted and expressed in pixels. The extent of pain was defined as the vector length extending from the ipsilateral earlobe to the most distal location of the pain.
RESULTS


The referred pain area from PPT+20% was smaller than PPT+30%, PPT+40%, and PPT+50%. The extent of referred pain did not differ between the pressure pain intensities.
CONCLUSIONS


Pressure intensity at PPT+30%, but no more, produces the greatest referred pain area as compared with the traditional pressure intensity of PPT+20%. Thus, the intensity of PPT+30% may be ideal for exploring the mechanisms of referred pain. The extent of the pain represents an independent expression of the intensity of the provoking stimulus and may be more closely related to the location of the stimulus.",2020,"The extent of referred pain did not differ between the pressure pain intensities.
",['Twenty-two healthy men and women participated in two experimental sessions'],[],"['level of DOMS on a 6-point Likert scale', 'pain referral area (number of pixels) and extent (vector length', 'muscle soreness (DOMS']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",22.0,0.0602879,"The extent of referred pain did not differ between the pressure pain intensities.
","[{'ForeName': 'Thorvaldur Skuli', 'Initials': 'TS', 'LastName': 'Palsson', 'Affiliation': ''}, {'ForeName': 'Shellie Ann', 'Initials': 'SA', 'LastName': 'Boudreau', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, SMI, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ortiz Lucas', 'Affiliation': 'Universidad San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bravo Esteban-Herreros', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), E.U.E. Fisioterapia de Toledo, Universidad de Castilla la Mancha, Ciudad real, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Garrigós-Pedrón', 'Affiliation': 'Departamento de Fisioterapia, Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Faculty of Health Sciences, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Doménech-García', 'Affiliation': 'Universidad San Jorge, Zaragoza, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa377']
2116,33120207,Longitudinal interrelationships of mental health discrimination and stigma with housing and well-being outcomes in adults with mental illness and recent experience of homelessness.,"RATIONALE


Stigma and discrimination are negatively associated with social and health status. People who are homeless often experience systemic stigma and discrimination.
OBJECTIVE


In this study, we analyze the longitudinal interrelationships between the trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma in a sample of adults with mental illness and recent experiences of homelessness in Toronto, Canada. We also examined the effect of the Housing First (HF) intervention on these interrelationships.
METHOD


The Group-Based Trajectory Model was used to estimate the interrelationship (or intersections) between discrimination and stigma with housing stability, recovery, quality of life, and community functioning in 274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period.
RESULTS


Three distinct trajectory groups were observed for discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High). Two-trajectory groups (Low and High) were identified for housing stability and community functioning. The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability. The HF intervention had a mitigating effect on the changes across select trajectory groups, particularly for members of the Low and High discrimination and stigma trajectories group.
CONCLUSION


Persistent mental health-related discrimination and stigma trajectories are longitudinally and contemporaneously interrelated with housing and well-being outcomes in persons experiencing mental illness and recent homelessness. These findings indicate the need for interventions and actions to reduce stigma toward thispopulation. Such interventions may improve housing stability, quality of life, mental health recovery, and community functioning.",2020,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","['274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period', 'adults with mental illness and recent experiences of homelessness in Toronto, Canada', 'adults with mental illness and recent experience of homelessness', 'persons experiencing mental illness and recent homelessness', 'People who are homeless often experience systemic stigma and discrimination']","['Housing First (HF) intervention', 'HF intervention']","['trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma', 'housing stability, recovery, quality of life, and community functioning ability', 'discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High', 'housing stability, quality of life, mental health recovery, and community functioning']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0676803', 'cui_str': 'Styrene-oxide isomerase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}]",274.0,0.0382565,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","[{'ForeName': 'Cilia', 'Initials': 'C', 'LastName': 'Mejia-Lancheros', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada. Electronic address: Cilia.Mejia-Lancheros@unityhealth.to.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lachaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Woodhall-Melnik', 'Affiliation': 'Department of Social Sciences, Faculty of Arts, University of New Brunswick, Saint John, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.""}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113463']
2117,33120238,Classification of renal tumour using convolutional neural networks to detect oncocytoma.,"PURPOSE


To investigate the ability of convolutional neural networks (CNNs) to facilitate differentiation of oncocytoma from renal cell carcinoma (RCC) using non-invasive imaging technology.
METHODS


Data were collected from 369 patients between January 2015 and September 2018. True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy. The data included 20,000 2D CT images. Data were randomly divided into sets for training (70 %), validation (10 %) and independent testing (20 %, DataTest_1). A small dataset (DataTest_2) was used for additional validation of the training model. Data were divided into sets at the patient level, rather than by individual image. A modified version of the ResNet50V2 was used. Accuracy of detecting benign or malignant renal mass was evaluated by a 51 % majority vote of individual image classifications to determine the classification for each patient.
RESULTS


Test results from DataTest_1 indicate an area under the curve (AUC) of 0.973 with 93.3 % accuracy and 93.5 % specificity. Results from DataTest_2 indicate an AUC of 0.946 with 90.0 % accuracy and 98.0 % specificity when evaluation is performed image by image. There is no case in which multiple false negative images originate from the same patient. When evaluated with 51 % majority of scans for each patient, the accuracy rises to 100 % and the incidence of false negatives falls to zero.
CONCLUSION


CNNs and deep learning technology can classify renal tumour masses as oncocytoma with high accuracy. This diagnostic method could prevent overtreatment for patients with renal masses.",2020,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"['Data were collected from 369 patients between January 2015 and September 2018', 'patients with renal masses']","['convolutional neural networks (CNNs', 'CNNs and deep learning technology']","['Accuracy of detecting benign or malignant renal mass', 'accuracy rises', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",369.0,0.020162,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: mikkped@ruc.dk.'}, {'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Herlev-Gentofte University Hospital, Herlev Ringvej 75, 2700, Herlev, Denmark. Electronic address: michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: henning@ruc.dk.'}, {'ForeName': 'Nessn H', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Department of Clinical Medicine, Copenhagen University, Sygehusvej 10, 4000, Roskilde, Denmark. Electronic address: nesa@regionsjaelland.dk.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109343']
2118,33120301,"Analgesic efficacy of ketamine and magnesium after laparoscopic sleeve gastrectomy: A randomized, double-blind, placebo-controlled trial.","Background Ketamine and magnesium are antagonists of the N-methyl-d-aspartate receptor, and are valuable adjuvants for multimodal analgesia and opioid sparing. Data are limited regarding the opioid sparing efficacy of the combined intraoperative application of these agents in laparoscopic bariatric surgery. The objective of this study was to compare the postoperative opioid sparing properties of a single intraoperative dose of ketamine versus a combination of single doses of ketamine and magnesium after laparoscopic gastric sleeve resection in bariatric patients. Methods One hundred and twenty- six patients were randomly assigned to receive single boluses of ketamine alone 0.5 mg kg -1  IV (ketamine group); combined ketamine bolus of 0.5 mg kg -1  IV and magnesium 2 g IV (ketamine and magnesium group); or placebo. Opioid consumption at 24 h (in morphine equivalents); pain at rest; postoperative nausea and vomiting impact score; sedation scores; and trends of transcutaneous carbon-di-oxide values were analysed. Results The median (inter-quartile range [range]) morphine consumption at 24 h were 32 (24-47 [4.8-91]) mg in the ketamine group, 37 (18-53 [1-144]) mg in the ketamine and magnesium group, and 26 (21-36 [5-89]) mg in the control group and were not significantly different between the groups. There were no differences for all other outcomes examined. Conclusion Combined single intraoperative bolus doses of ketamine and magnesium did not result in postoperative opioid sparing after laparoscopic gastric sleeve resection.",2020,morphine consumption at 24 h were 32,"['after laparoscopic gastric sleeve resection', 'bariatric patients', 'Methods One hundred and twenty- six patients', 'after laparoscopic sleeve gastrectomy', 'consumption at 24\xa0h were 32']","[' Ketamine and magnesium', 'laparoscopic gastric sleeve resection', 'ketamine', 'ketamine alone 0.5\xa0mg\xa0kg -1  IV (ketamine group); combined ketamine bolus of 0.5\xa0mg\xa0kg -1  IV and magnesium 2\xa0g IV (ketamine and magnesium group); or placebo', 'placebo', 'ketamine and magnesium', 'morphine']","['Opioid consumption', 'nausea and vomiting impact score; sedation scores', 'transcutaneous carbon-di-oxide values', 'Analgesic efficacy', 'postoperative opioid sparing']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]",126.0,0.636448,morphine consumption at 24 h were 32,"[{'ForeName': 'Sanjib Das', 'Initials': 'SD', 'LastName': 'Adhikary', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America. Electronic address: sadhikary@pennstatehealth.psu.edu.'}, {'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Department of Anaesthesia, The University of Adelaide, Woodville South, SA 5011, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'St. Claire Hospital, Department of Anesthesiology, 1000 Bower Hill Rd, Pittsburgh, PA 15243, United States of America.'}, {'ForeName': 'Wai Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Research School of Finance, Actuarial Studies and Statistics, Australian National University, Canberra ACT 0200, Australian Capital Territory, Australia.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Mets', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Penn State Hershey Medical Center, Surgical Weight Loss Program, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110097']
2119,33120302,Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial.,"STUDY OBJECTIVE


Delirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment. The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.
DESIGN


The Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.
SETTING


Perioperative care.
PATIENTS


182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.
INTERVENTIONS


Pre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.
MEASUREMENTS


Assessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.
MAIN RESULTS


None of the three study arms - haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
CONCLUSIONS


The study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.
TRIAL REGISTRATION


ClinicalTrials.govNCT02433041; registered on April 7, 2015.",2020,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","['patients with cognitive deterioration suggest affection of glial cells in particular', '182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia']","['haloperidol, ketamine', 'Ketamine vs. haloperidol', 'haloperidol and ketamine', 'placebo', 'haloperidol, ketamine, and the combination of both vs. placebo']","['pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β', 'cognitive dysfunction and postoperative delirium', 'postoperative NSE levels', 'cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay', 'Measured levels of postoperative cortisol', 'S-100β levels', 'postoperative brain dysfunction and delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",182.0,0.394449,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Alexa.Hollinger@usb.ch.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Rüst', 'Affiliation': 'Institute of Primary Care, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland. Electronic address: christoph.ruest@bluewin.ch.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Riegger', 'Affiliation': 'Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: HarrietYvonne.Riegger@usb.ch.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: bianca.gysi@stud.unibas.ch.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: fabian.tran@stud.unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jonas.bruegger@stud.unibas.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jan.huber@vtxmail.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Toft', 'Affiliation': 'Department for Anaesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg Branches, Asylstrasse 19, 8810 Horgen, Switzerland. Electronic address: Katharina.Toft@gmail.com.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Surbeck', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: madlen.surbeck@stud.unibas.ch.'}, {'ForeName': 'Hans-Ruedi', 'Initials': 'HR', 'LastName': 'Schmid', 'Affiliation': 'Central Laboratory, Cantonal Hospital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: Hans-Ruedi.Schmid@ksb.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department of Clinical Chemistry and Laboratory Medicine, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: Katharina.Rentsch@usb.ch.'}, {'ForeName': 'Luzius', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: Luzius.Steiner@usb.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Martin.Siegemund@usb.ch.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110099']
2120,33120482,"[A multicenter, randomized, open and positive parallel controlled clinical study of clotrimazole vaginal expansion suppository and vaginal tablet in the treatment of mild and moderate vulvovaginal candidiasis].","Objective:  Using clotrimazole vaginal tablet as a positive control, to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy, patient satisfaction, side effects, and recurrence rate.  Methods:  This study was jointly conducted by 5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected. They were randomized to experimental group and control group as 1∶1 ratio. In the experimental group ( n =105), the subjects applied clotrimazole vaginal expansion suppository (150 mg) daily at night for 7 days. In the control group ( n =106), the subjects used a single dose of clotrimazole vaginal tablet (500 mg). Follow-ups were performed at (8±3) and (30±5) days after the discontinuation of the drugs, respectively. The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms, and the patient's satisfaction and side effects were recorded.  Results:  At the first follow-up, the experimental group and control group were followed up by fungal culture on the cure rate [66.7% (70/105) versus 63.2% (67/106),  P >0.05] and total effective rate [98.1% (103/105) versus 99.1% (105/106),  P >0.05], the differences were not statistically significant. At the second follow-up, the recurrence rates of the experimental group and the control group were 5.7% (4/70) and 14.9% (10/67), respectively, with no significant difference ( P >0.05). In the evaluation of patient satisfaction, the leakage of the drug in the experimental group was significantly better than that in the control group ( P <0.01). The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  Conclusions:  In the treatment of mild and moderate vulvovaginal candidiasis, clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet, and there is no significant difference in the recurrence rate between the two. In terms of patient satisfaction, clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.",2020,"The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  ","['5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected', 'mild and moderate vulvovaginal candidiasis']","['clotrimazole vaginal expansion suppository and vaginal tablet', 'clotrimazole vaginal expansion suppository', 'clotrimazole vaginal tablet', 'clotrimazole']","['vaginal stimulation, itching and burning sensation', 'total effective rate', 'recurrence rates', 'cure rate', 'clinical symptoms and signs scores', 'efficacy, patient satisfaction, side effects, and recurrence rate', 'mild and moderate vulvovaginal candidiasis', 'recurrence rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}]",,0.0386629,"The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'Q P', 'Initials': 'QP', 'LastName': 'Liao', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University First hospital, Beijing 100034, China.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'An', 'Affiliation': ""Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zheng', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'Q Q', 'Initials': 'QQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200403-00293']
2121,33120484,[Evaluation of the effectiveness of BMRT-HPV for cervical cancer screening].,"Objective:  Evaluation of the clinical value of the BioPerfectus multiplex real time (BMRT)-HPV for cervical cancer screening.  Methods:  Physician-collected specimens of 1 495 women who were positive of Cobas 4800 HPV (Cobas-HPV), HPV genotyping based on SEQ uencing (SEQ-HPV), and (or) cytology ≥low grade squamous intraepithelial lesion (LSIL) in the primary screening of Chinese Multiple-center Screening Trial (CHIMUST), and 2 990 women selected from those who were negative of primary screening in the same project through nested control randomization with age-matching were tested for BMRT-HPV, which reported type-specific viral loads/10 000 cells in each specimen. With comparing to Cobas-HPV results and taking cervical histopathological diagnosis as the endpoint, the concordance of high-risk (HR)-HPV subtypes among the three assays was explored ,and the sensitivity and specificity of BMRT-HPV for cervical cancer screening were evaluated.  Results:  (1) The overall agreenment of HR-HPV subtypes between BMRT-HPV and Cobas-HPV, or SEQ-HPV test sample was 94.8%, 94.4%, with Kappa values 0.827, 0.814. (2) The sensitivity and specificity for cervical intraepithelial neoplasia (CIN) Ⅱ +  of BMRT-HPV, Cobas-HPV and SEQ-HPV were 92.62%, 94.26%, 93.44% and 84.67%, 83.25%, 82.76%, respectively. There were no significant difference in sensitivity among the three HPV assays (all  P >0.05), but the specificity of BMRT-HPV for CIN Ⅱ +  was higher than those of Cobas-HPV and SEQ-HPV ( P <0.01). The sensitivity for CIN Ⅲ +  of three HPV assays were all 100.00%, and the specificity for CIN Ⅲ +  of BMRT-HPV was higher than those of Cobas-HPV and SEQ-HPV (83.40% vs 81.95%, 83.40% vs 81.50%;  P <0.01). The number of pathological examinations of colposcopy for cervical biopsy detected in 1 case of CIN Ⅱ +  or CIN Ⅲ +  in BMRT-HPV was less than those in Cobas-HPV and SEQ-HPV ( P <0.01). When using HPV 16/18 + cytology ≥atypical squamous cell of undetermined signification (ASCUS) to triage HPV positive women among three assays, there was no different in the sensitivities of detecting CIN Ⅱ +  and CIN Ⅲ +  ( P >0.05). The specificity BMRT-HPV was slightly higher than those in Cobas-HPV or SEQ-HPV (all  P <0.05), and the colposcopy referral rate was lower than those in Cobas-HPV and SEQ-HPV (all  P <0.05).  Conclusions:  BMRT-HPV is as sensitive as Cobas-HPV or SEQ-HPV for primary cervical cancer screening, and has higher specificity. Therefore it could be used as a primary screening method for cervical cancer, which is worthy of clinical application.",2020,"There were no significant difference in sensitivity among the three HPV assays (all  P >0.05), but the specificity of BMRT-HPV for CIN Ⅱ +  was higher than those of Cobas-HPV and SEQ-HPV ( P <0.01).","['cervical cancer screening', 'Physician-collected specimens of 1 495 women who were positive of Cobas 4800 HPV (Cobas-HPV), HPV genotyping based on SEQ uencing (SEQ-HPV), and (or) cytology ≥low grade squamous intraepithelial lesion (LSIL) in the primary screening of Chinese Multiple-center Screening Trial (CHIMUST), and 2 990 women selected from those who were negative of primary screening in the same project through nested control randomization with age-matching were tested for BMRT-HPV, which reported type-specific viral loads/10 000 cells in each specimen']","['BMRT-HPV', 'BioPerfectus multiplex real time (BMRT)-HPV']","['number of pathological examinations of colposcopy for cervical biopsy', 'overall agreenment of HR-HPV subtypes between BMRT-HPV and Cobas-HPV, or SEQ-HPV test sample', 'sensitivity', 'sensitivity and specificity for cervical intraepithelial neoplasia (CIN) Ⅱ +  of BMRT-HPV, Cobas-HPV and SEQ-HPV', 'specificity for CIN Ⅲ +  of BMRT-HPV', 'specificity of BMRT-HPV for CIN Ⅱ ', 'colposcopy referral rate', 'specificity BMRT-HPV']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0585733', 'cui_str': 'Report type'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0195314', 'cui_str': 'Cervical biopsy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",,0.0427341,"There were no significant difference in sensitivity among the three HPV assays (all  P >0.05), but the specificity of BMRT-HPV for CIN Ⅱ +  was higher than those of Cobas-HPV and SEQ-HPV ( P <0.01).","[{'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Duan', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Qu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}, {'ForeName': 'X Z', 'Initials': 'XZ', 'LastName': 'Duan', 'Affiliation': 'Department of Obstetrics and Gynecology, Capital Medical University Beijing Tongren Hospital, Beijing 100730, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Huashan Hospital, Fudan University, Shanghai 200003, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Hospital of Hebei Medical University, Shijiazhuang 050005, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Belinson', 'Affiliation': 'Preventive Oncology International, Cleveland Heights, OH, United States of America, 44101.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen 518036, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200325-00266']
2122,33120637,"Endophthalmitis Prophylaxis Study, Report 2: Intracameral antibiotic prophylaxis with or without postoperative topical antibiotic in cataract surgery.","Purpose


Intracameral antibiotic in cataract surgery has shown level I evidence as prophylaxis for postoperative endophthalmitis. Not much is known if one should also use topical antibiotics after intracameral injection. The purpose of the study was to determine efficacy of intracameral antibiotic with and without postoperative topical antibiotic in reducing the incidence of acute endophthalmitis after cataract surgery in rural India.
Methods


A.
prospective comparative, non-randomized interventional study was designed in 15 rural centres in India. The study recruited 40,006 patients (n = 42,466 eyes), who underwent cataract surgery (phacoemulsification/small incision cataract surgery), and received intracameral antibiotic (cefuroxime/moxifloxacin). Postoperative topical antibiotic prescription was left to the choice of the treating physician, but they were encouraged not to use it in uneventful surgeries. Primary outcome measure was occurrence of acute clinical endophthalmitis within 6 weeks of surgery. Statistical analysis was done using STATA software v13.1 (StataCorp, Texas); P value of <0.05 was considered statistically significant.
Results


In the study, 17,932 (42%) eyes received intracameral cefuroxime (ICC) and 24,534 (58%) eyes received intracameral moxifloxacin (ICM). Topical antibiotic was not prescribed to 17,855 (42%) eyes - 5723 (32%) eyes in ICC group and 12,132 (68%) eyes in ICM group. Acute clinical endophthalmitis occurred in 15 (0.035%) eyes - 1 / 3515 (0.028%) eyes and 1 / 2231 (0.045%) eyes that received and did not receive topical antibiotic, respectively. The difference in occurrence of endophthalmitis with/without topical antibiotics in each group (ICC: 0.016% and 0.017%; P = 0.958; ICM: 0.040% and 0.058%; P = 0.538) was not significant (P = 0.376).
Conclusion


Supplementing intracameral antibiotic with topical antibiotic postoperatively did not impact the occurrence of acute post cataract surgery endophthalmitis in rural India.",2020,"Acute clinical endophthalmitis occurred in 15 (0.035%) eyes - 1 / 3515 (0.028%) eyes and 1 / 2231 (0.045%) eyes that received and did not receive topical antibiotic, respectively.","['acute endophthalmitis after cataract surgery in rural India', '40,006 patients (n = 42,466 eyes), who underwent', '15 rural centres in India', 'cataract surgery', 'acute post cataract surgery endophthalmitis in rural India']","['intracameral antibiotic (cefuroxime/moxifloxacin', 'intracameral cefuroxime (ICC', 'intracameral moxifloxacin (ICM', 'intracameral antibiotic with and without postoperative topical antibiotic', 'Intracameral antibiotic', 'cataract surgery (phacoemulsification/small incision cataract surgery', 'Intracameral antibiotic prophylaxis with or without postoperative topical antibiotic']","['occurrence of acute clinical endophthalmitis', 'occurrence of endophthalmitis', 'Acute clinical endophthalmitis', 'Topical antibiotic']","[{'cui': 'C0154773', 'cui_str': 'Acute endophthalmitis'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",40006.0,0.090005,"Acute clinical endophthalmitis occurred in 15 (0.035%) eyes - 1 / 3515 (0.028%) eyes and 1 / 2231 (0.045%) eyes that received and did not receive topical antibiotic, respectively.","[{'ForeName': 'Varsha M', 'Initials': 'VM', 'LastName': 'Rathi', 'Affiliation': 'Allen Foster Research Centre for Community Eye Health, Gullapalli Pratibha Rao International Centre for Advancement of Rural Eye Care, L V Prasad Eye Institute (LVPEI), Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Savitri', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Jhaveri Microbiology Centre, Brien Holden Eye Research Centre, LVPEI, Hyderabad, India.'}, {'ForeName': 'Taraprasad', 'Initials': 'T', 'LastName': 'Das', 'Affiliation': 'Kanuri Santhamma Center for Vitreoretinal Diseases, LVPEI, Hyderabad, India.'}, {'ForeName': 'Rohit C', 'Initials': 'RC', 'LastName': 'Khanna', 'Affiliation': 'Allen Foster Research Centre for Community Eye Health, Gullapalli Pratibha Rao International Centre for Advancement of Rural Eye Care, L V Prasad Eye Institute (LVPEI), Banjara Hills, Hyderabad, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1738_19']
2123,33120756,Clinical study on acupuncture acupoints around the eyes in treating myopia in children and adolescents: A study protocol.,"INTRODUCTION


Myopia is the most common cause of avoidable visual impairment worldwide, which causes huge economic burden and social burden. There are several ways to treat and reduce myopia, but all have drawbacks; this reality drives us to search for additional effective and low-risk interventions of treatment for myopia. Acupuncture is an ancient therapy with a history of thousands of years and is now widely used in the medical system. Some randomized controlled trials have reported that acupuncture, as an adjuvant therapy, can effectively improve the diopter and vision in the sense of myopic children. Deqi is a long-standing belief to ensure the efficacy of acupuncture in the treatment of myopia, but this belief has not been confirmed by sufficient evidence of randomized controlled trials.
METHODS


This clinical study is a parallel-group, randomized controlled, and single blind study. Three hundred eligible adolescents will randomly be divided into acupuncture Deqi group, acupuncture without Deqi group, and waiting list group. All groups will be given frame glasses for corrective treatment; patients in the acupuncture Deqi group will be treated with acupuncture at acupoints around the eyes and flat puncture to Deqi, while acupuncture without Deqi group will not flat puncture to Deqi. The waiting list group will not receive acupuncture treatment. The primary outcome will be diopter measurement. Adverse events and safety indexes will be recorded throughout the study.
DISCUSSION


Our study will compare acupuncture Deqi with acupuncture without Deqi, and place it in a control group for the treatment of myopia. The results of this trial are expected to provide solid evidence for the effectiveness and safety of acupuncture combined with Deqi in the treatment of myopia, and hope to provide a reference for clinical practice. The primary outcome will be diopter measurement of the patients before treatment.
TRIAL REGISTRATION


ChiCTR2000037874, registered September 3, 2020.",2020,"Myopia is the most common cause of avoidable visual impairment worldwide, which causes huge economic burden and social burden.","['Three hundred eligible adolescents', 'children and adolescents']","['Acupuncture', 'acupuncture acupoints', 'acupuncture Deqi', 'acupuncture at acupoints around the eyes and flat puncture to Deqi, while acupuncture without Deqi group will not flat puncture to Deqi', 'acupuncture', 'acupuncture Deqi with acupuncture', 'acupuncture Deqi group, acupuncture without Deqi group, and waiting list group']","['Adverse events and safety indexes', 'diopter measurement of the patients before treatment']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",300.0,0.268168,"Myopia is the most common cause of avoidable visual impairment worldwide, which causes huge economic burden and social burden.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Yanlin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xili', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology.'}]",Medicine,['10.1097/MD.0000000000022659']
2124,33120777,The effect of acupuncture on depression and its correlation with metabolic alterations: A randomized controlled trial.,"BACKGROUND


Electroacupuncture (EA) treatment has antidepressant effect and when patients were treated with EA and antidepressants, the effect could be maintained for a longer time. However, the effect of EA combined with antidepressants based on metabolism is still in the initial observation stage, which requires further research.
METHODS


A total of 60 patients with moderate depression were assigned into 2 groups at a ratio of 1:1, the EA group (receiving EA and antidepressants) and the control group (taking antidepressants only) in this randomized controlled pilot trial. The EA treatment was performed 3 times a week for 8 consecutive weeks and then follow up for 4 weeks. The patients' depressive mood was measured by the Hamilton Depression scale (HAMD) at baseline, week 4, week 8 and week 12. Before and after 8-week treatment, morning urine samples from all patients were analyzed by the gas chromatography-mass spectrometry (GC-MS) to find possible metabolic markers of depression and of EA treatment related changes.
RESULTS


Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001). The significant differences in urinary specific metabolites before and after EA treatment were malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine. These metabolites are involved in tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis.
CONCLUSION


EA treatment combined with antidepressants is more effective in improving depressive symptoms than antidepressants alone. EA may treat depression by acting on tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR-2000030786.",2020,"Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001).",['60 patients with moderate depression'],"['Electroacupuncture (EA', 'EA group (receiving EA and antidepressants', 'acupuncture']","['malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine', 'Hamilton Depression scale (HAMD', 'depressive symptoms', 'urinary specific metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0065591', 'cui_str': 'Malonic acid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067783', 'cui_str': 'N-acetylserotonin'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",60.0,0.101856,"Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Manqin', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Zaoyuan', 'Initials': 'Z', 'LastName': 'Kuang', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Medicine,['10.1097/MD.0000000000022752']
2125,33120779,The efficacy of a phone assistance nursing program for functional outcomes in patients after shoulder instability surgery: A protocol for randomized controlled trial.,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
METHODS


This is a randomized controlled, single center trial which will be implemented from October 2020 to December 2021. This trial is conducted according to the SPIRIT Checklist of randomized researches. It was authorized via the Ethics Committee of the First People's Hospital of Xiangyang city affiliated to Hubei Medical College (XY234-026). Ninety participants who undergo shoulder instability surgery are analyzed. Patients are randomly divided into control group (standard management group, with 45 patients) and study group (the phone program group, with 45 patients). In control group, the exercises at home are not monitored. Whereas in study group, patients are asked about their at-home activities, and the extra coaching sessions are provided to patients on self-care, exercise guidance, and the importance of exercise at home, and then answers to their questions. The primary outcome is the range of motion of the shoulder joint, and the pain arcs are determined through the range of motion. The extra assessments include the shoulder functional outcome, pain, and the quality of life. All the analysis needed in this study is implemented with SPSS (IBM, Chicago, USA) for Windows Version 19.0.
RESULTS


The clinical outcome variables between groups are shown in Table.
CONCLUSION


This investigation can offer a reliable basis for the effectiveness of phone assistance nursing program in patients after shoulder instability surgery.
TRIAL REGISTRATION NUMBER


researchregistry6010.",2020,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
","['October 2020 to December 2021', 'patients after shoulder instability surgery', 'Ninety participants who undergo shoulder instability surgery are analyzed', ""First People's Hospital of Xiangyang city affiliated to Hubei Medical College (XY234-026"", 'patients receiving shoulder instability surgery']","['phone-assisted care programs', 'phone assistance nursing program']","['range of motion of the shoulder joint, and the pain arcs are determined through the range of motion', 'functional outcomes', 'shoulder functional outcome, pain, and the quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.0880653,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
","[{'ForeName': 'Yongling', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Junchang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Gynaecology and Obstetrics, the First People's Hospital of Xiangyang City Affiliated to Hubei Medical College, Hubei, China.""}]",Medicine,['10.1097/MD.0000000000022756']
2126,33120788,Cone beam computed tomography imaging of sagittal positions of the mandibular prominence and maxillary central incisors in adult Chinese Han men as an aesthetic profile determinant.,"BACKGROUND


To analyze the sagittal positions of the mandibular prominence and maxillary central incisors in adult Chinese Han men to establish their aesthetic profile characteristics.
METHODS


Seventy-four Chinese Han men aged 18 to 40 years underwent cone beam computed tomography for detecting the distances between Glabella and Subnasale, Subnasale and Menthon of soft tissue, Condyle and Gonion, Pogonion and Pogonion's Anterior Limit Line, Facial Axis point of maxillary central incisor and the Goal Anterior Limit Line as well as the angle of the Occlusal Plane. Dolphin Imaging and Photoshop software packages were used to generate silhouette profiles. Thirteen orthodontists assessed the silhouette profiles and assigned visual analog scale scores. Scores >70 were assigned to the aesthetic (group 1), scores of 60to 70 to the general (group 2), scores of 50 to 60 to the acceptable (group 3), and scores of <50 to the unaesthetic profile (group 4).
RESULTS


A total of 15 men were assigned to group 1, 35 to group 2, 14 to group 3, and 10 to group 4. There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
CONCLUSION


Compared with the unaesthetic profile group, the sagittal positions of the maxillary central incisors were slightly posterior, and the chin was slightly anterior in adult Chinese Han men with an aesthetic profile.",2020,"There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
","['A total of 15 men', 'Seventy-four Chinese Han men aged 18 to 40 years underwent', 'adult Chinese Han men with an aesthetic profile', 'adult Chinese Han men']","['Dolphin Imaging and Photoshop software packages', ""cone beam computed tomography for detecting the distances between Glabella and Subnasale, Subnasale and Menthon of soft tissue, Condyle and Gonion, Pogonion and Pogonion's Anterior Limit Line, Facial Axis point of maxillary central incisor"", 'Cone beam computed tomography imaging of sagittal positions']","['silhouette profiles and assigned visual analog scale scores', 'Facial Axis-Goal Anterior Limit Line']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0641339', 'cui_str': 'hexaaquanickel(II) chlorate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C1185651', 'cui_str': 'Cephalometric gonion point'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",15.0,0.051886,"There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Miao', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}, {'ForeName': 'Zhiyao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Stomatology, Xi'an First Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zuolin', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}]",Medicine,['10.1097/MD.0000000000022778']
2127,33120808,Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder: A study protocol.,"BACKGROUND


The persistent loss of consciousness caused by general anesthesia without the existence of repeated 90-minute cycles of non-REM and REM sleep might significantly disturb and suppress the cycle of normal physiological sleep in postoperative periods after general anesthesia. Patients with autism spectrum disorders (ASD) with existing circadian rhythm disorder are reported to rapidly deteriorate due to acute sleep disorder during the perioperative period after general anesthesia.A melatonin receptor agonist, ramelteon (Rozerem), which is a sleep cycle regulator, is used as a therapeutic drug for patients with sleep disorders, but there are no studies on the prevention of postoperative sleep disorder after general anesthesia.In this study, we investigate whether prophylactic administration of a sleep-inducing substance, a melatonin receptor agonist, is effective against sleep disorder after general anesthesia in patients with ASD.
METHODS/DESIGN


This study is intended for patients with ASD aged 12 years and above who undergo treatment at Nagasaki University Hospital, Isahaya General Hospital Dentistry, and Sasebo City General Medical Center Dentistry and undergo dental treatment under general anesthesia. A melatonin receptor agonist (Rozerem) will be taken 7 days prior and 7 days postsurgery in patients diagnosed with insomnia. A randomized comparison will be made between 2 groups: an experimental group that is additionally administered Rozerem and a control group.The primary endpoint is the incidence of NREM-REM sleep disorders that occur within 3 to 5 days after general anesthesia. The secondary endpoint is the incidence of circadian rhythm sleep disorders (rate of occurrence of sleep-retardation syndrome with drowsiness and strong fatigue).
DISCUSSION


Postoperative sleep disorders after general anesthesia has been reported in patients with ASD; however, effective preventive pharmacological treatments have not been established. A sleep cycle regulator, ramelteon (Rozerem), is used as a therapeutic drug for patients with sleep disorders by decreasing the difficulty of falling asleep in insomnia. If sleep disorder can be prevented after the administration of general anesthesia in patients with ASD, we can support social participation while maintaining their quality of life.
TRIAL REGISTRATION


The study was registered with the jRCT1071200030.",2020,The primary endpoint is the incidence of NREM-REM sleep disorders that occur within 3 to 5 days after general anesthesia.,"['patients with ASD', 'patients diagnosed with insomnia', 'patients with autism spectrum disorder', 'Patients with autism spectrum disorders (ASD) with existing circadian rhythm disorder', 'patients with sleep disorders', 'patients with ASD aged 12 years and above who undergo treatment at Nagasaki University Hospital, Isahaya General Hospital Dentistry, and Sasebo City General Medical Center Dentistry and undergo dental treatment under general anesthesia']","['melatonin receptor agonist', 'melatonin receptor agonist (Rozerem']","['incidence of NREM-REM sleep disorders', 'incidence of circadian rhythm sleep disorders (rate of occurrence of sleep-retardation syndrome with drowsiness and strong fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0813142', 'cui_str': 'Circadian Dysregulation'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C3541970', 'cui_str': 'Melatonin receptor agonists'}, {'cui': 'C1621477', 'cui_str': 'Rozerem'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0877792', 'cui_str': 'Disorder of sleep-wake cycle'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0448557,The primary endpoint is the incidence of NREM-REM sleep disorders that occur within 3 to 5 days after general anesthesia.,"[{'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ozaki-Honda', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kiriishi', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Magata', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaguchi-Komeyama', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Tanoue', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}]",Medicine,['10.1097/MD.0000000000022826']
2128,33121063,Tunneled Peritoneal Catheter for Refractory Ascites in Cirrhosis: A Randomized Case-Series.,"BACKGROUND AND OBJECTIVES


Refractory ascites markedly worsens prognosis in cirrhosis. Large volume paracentesis (LVP) is standard treatment, but complications are common. In a randomized controlled case-series, we assessed a permanent tunneled peritoneal catheter versus LVP in patients with cirrhosis and ascites.
MATERIALS AND METHODS


Random allocation was computer-generated, and concealment used opaque envelopes. Patients were included from January 2017 to December 2018. Inclusion criteria were cirrhosis and recurrent ascites and expected survival of more than 3 months.
RESULTS


Thirteen patients were enrolled (PleurX =6 versus LVP = 7). Seven were female, ranging in age from 51 to 80 years. No procedure-related complications occurred. Two patients died due to variceal bleeding (PleurX-group) and sepsis (LVP-group). One patient was withdrawn due to hyponatremia (PleurX-group). Two patients were withdrawn due to bacterial peritonitis and infection of unknown origin (control-group). In the PleurX-group, all patients colonized the catheter, two developed bacterial peritonitis. The most common bacterial colonization was  Staph. Epidermidis  ( n  = 4).
CONCLUSIONS


In selected patients, the PleurX catheter mobilizes ascites and may be an alternative to LVP. The risk of infection should be considered in each case. The impact of colonization and risk of infections needs further investigation. The present trial does not allow for statistical conclusions.",2020,No procedure-related complications occurred.,"['Two patients were withdrawn due to bacterial peritonitis and infection of unknown origin (control-group', 'Cirrhosis', 'Patients were included from January 2017 to December 2018', 'Thirteen patients were enrolled (PleurX =6 versus LVP = 7', 'Seven were female, ranging in age from 51 to 80 years', 'cirrhosis', 'Two patients died due to variceal bleeding (PleurX-group) and sepsis (LVP-group', 'patients with cirrhosis and ascites']","['Tunneled Peritoneal Catheter', 'Large volume paracentesis (LVP', 'permanent tunneled peritoneal catheter versus LVP']",['bacterial peritonitis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0179781', 'cui_str': 'Peritoneal catheter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}]",[],2.0,0.0748056,No procedure-related complications occurred.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kimer', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Agnete Nordheim', 'Initials': 'AN', 'LastName': 'Riedel', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Hobolth', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mortensen', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Lone Galmstrup', 'Initials': 'LG', 'LastName': 'Madsen', 'Affiliation': 'Department of Clinical Medicine, University Hospital Køge, 4600 Køge, Denmark.'}, {'ForeName': 'Mette Lehmann', 'Initials': 'ML', 'LastName': 'Andersen', 'Affiliation': 'Department of Gastroenterology, University Hospital Herlev, 2630 Herlev, Denmark.'}, {'ForeName': 'Frank Vinholdt', 'Initials': 'FV', 'LastName': 'Schiødt', 'Affiliation': 'Abdominal Center K, University Hospital Bispebjerg, 2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Møller', 'Affiliation': 'Center of Functional and Diagnostic Imaging and Research, Department of Clinical and Nuclear Medicine, Amager-Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Lise Lotte', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre University Hospital, 2650 Hvidovre, Denmark.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110565']
2129,33121117,Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Randomized Controlled Pilot Study.,"The aim of this study was to examine the effect of adjunct local minocycline administration on the microbiological parameters of subgingival plaque samples in the residual periodontal pockets. Ten chronic periodontitis patients under a supportive periodontal therapy regimen were recruited. After subgingival debridement, either 2% minocycline gel, Periocline™, (Test Group) or a placebo (Control Group) was administered to the selected sites once a week for three weeks. Subgingival plaque was collected at baseline, and at four weeks and eight weeks. The microbiological composition was analyzed by 16S ribosomal RNA sequencing. In the Test Group, α-diversity (evenness) decreased compared to the baseline ( p  = 0.005) and was lower compared to the control group at four weeks ( p  = 0.003). The microbial community composition between the two groups was significantly different at four weeks ( p  = 0.029). These changes were attributable to a decrease in the bacteria associated with periodontitis and an increase in the bacteria associated with periodontal health. Additionally, the improvement in bleeding on probing continued at eight weeks; however, there were little microbial effects of 2% minocycline gel observed at eight weeks. The control group demonstrated no change throughout the eight-week experimental period. Thus, local minocycline administration can change the subgingival microbial community of residual periodontal pockets.",2020,"In the Test Group, α-diversity (evenness) decreased compared to the baseline ( p  = 0.005) and was lower compared to the control group at four weeks ( p  = 0.003).","['subgingival plaque samples in the residual periodontal pockets', 'Ten chronic periodontitis patients under a supportive periodontal therapy regimen were recruited']","['minocycline gel, Periocline', 'placebo', 'Minocycline', 'adjunct local minocycline', 'minocycline']","['α-diversity (evenness', 'Subgingival plaque', 'Subgingival Microbiota', 'microbial community composition', 'bleeding']","[{'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",10.0,0.0222961,"In the Test Group, α-diversity (evenness) decreased compared to the baseline ( p  = 0.005) and was lower compared to the control group at four weeks ( p  = 0.003).","[{'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Miyazawa', 'Affiliation': 'Research Unit for Oral-Systemic Connection, Division of Oral Science for Health Promotion, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Research Unit for Oral-Systemic Connection, Division of Oral Science for Health Promotion, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Horimizu', 'Affiliation': 'Division of Periodontology, Department of Oral Biological Science, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Okuda', 'Affiliation': 'Division of Periodontology, Department of Oral Biological Science, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugita', 'Affiliation': 'Division of Periodontology, Department of Oral Biological Science, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Research Unit for Oral-Systemic Connection, Division of Oral Science for Health Promotion, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Computer Science and Engineering, State University of New York at Buffalo, 338 Davis Hall, Buffalo, NY 14214, USA.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Hayashi-Okada', 'Affiliation': 'Sunstar Inc., 3-1, Asahimachi, Takatsuki-shi, Osaka 569-1134, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Arita', 'Affiliation': 'Sunstar Inc., 3-1, Asahimachi, Takatsuki-shi, Osaka 569-1134, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Sunstar Inc., 3-1, Asahimachi, Takatsuki-shi, Osaka 569-1134, Japan.'}, {'ForeName': 'Mieko', 'Initials': 'M', 'LastName': 'Nishida', 'Affiliation': 'Sunstar Inc., 3-1, Asahimachi, Takatsuki-shi, Osaka 569-1134, Japan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Genco', 'Affiliation': 'Departments of Oral Biology, and Microbiology and Immunology, and Center for Microbiome Research, University at Buffalo, 135 Foster Hall, 3435 Main Street, Buffalo, NY 14214, USA.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Research Unit for Oral-Systemic Connection, Division of Oral Science for Health Promotion, Niigata University Graduate School of Medical and Dental Sciences, 2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.'}]",Dentistry journal,['10.3390/dj8040123']
2130,33121121,Effects of Unloaded vs. Ankle-Loaded Plyometric Training on the Physical Fitness of U-17 Male Soccer Players.,"The aim of this study was to compare the impact of two differing plyometric training programs (loaded plyometrics (with 2.5% of body mass placed above the ankle joint) vs. unloaded plyometrics), performed biweekly for 10 weeks, on the physical fitness of elite junior male soccer players. Participants aged 16.0 ± 0.5 years were randomly assigned between unloaded plyometrics (UP;  n  = 12), loaded plyometrics (LP;  n  = 14) and control (C;  n  = 12) groups. Two-way analyses of performance (group x time) were assessed by 40-m sprint times; 9-3-6-3-9 m sprints with 180° turns (S180°); 9-3-6-3-9 m sprints with backward and forward running (SBF); and 4 × 5 m sprints (S4 × 5 m); four jump tests; measures of static and dynamic balance; repeated change of direction tests and the Yo-Yo intermittent recovery test. Both LP and UP enhanced sprinting performance relative to C ( p  < 0.05) but performance increased more in LP relative to UP ( p  < 0.05) in all sprints except 40 m. Change of direction times were also significantly shortened by LP relative to UP ( p  < 0.05) and C ( p  < 0.01) in all tests, with no significant differences between UP and C. Jumps heights increased similarly in both LP and UP relative to C ( p  < 0.05), with no significance between LP and UP. LP and UP also enhanced repeated change of direction scores relative to C ( p  < 0.01) with greater changes in LP than in UP ( p  < 0.01). Finally, LP enhanced some balance scores relative to UP ( p  < 0.05) and C ( p  < 0.05). We conclude that the introduction of 10 weeks of in-season loaded plyometrics into the regimen of U17 male soccer players yields gains in several physical performance scores relative to either unloaded plyometrics or the control training regimen.",2020,"Both LP and UP enhanced sprinting performance relative to C ( p  < 0.05) but performance increased more in LP relative to UP ( p  < 0.05) in all sprints except 40 m. Change of direction times were also significantly shortened by LP relative to UP ( p  < 0.05) and C ( p  < 0.01) in all tests, with no significant differences between UP and C. Jumps heights increased similarly in both LP and UP relative to C ( p  < 0.05), with no significance between LP and UP.","['Participants aged 16.0 ± 0.5 years', 'U-17 Male Soccer Players', 'elite junior male soccer players', 'U17 male soccer players']","['Unloaded vs. Ankle-Loaded Plyometric Training', 'plyometric training programs (loaded plyometrics (with 2.5% of body mass placed above the ankle joint) vs. unloaded plyometrics', 'static and dynamic balance; repeated change of direction tests and the Yo-Yo intermittent recovery test']","['UP and C. Jumps heights', 'yields gains in several physical performance scores']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0164211,"Both LP and UP enhanced sprinting performance relative to C ( p  < 0.05) but performance increased more in LP relative to UP ( p  < 0.05) in all sprints except 40 m. Change of direction times were also significantly shortened by LP relative to UP ( p  < 0.05) and C ( p  < 0.01) in all tests, with no significant differences between UP and C. Jumps heights increased similarly in both LP and UP relative to C ( p  < 0.05), with no significance between LP and UP.","[{'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'Research Unit (UR17JS01) «Sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", 2010 Tunis, Tunisia.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Gaamouri', 'Affiliation': 'Research Unit (UR17JS01) «Sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", 2010 Tunis, Tunisia.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa 359-1192, Japan.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Aouadi', 'Affiliation': 'Research Unit (UR17JS01) «Sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", 2010 Tunis, Tunisia.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S, Canada.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'Research Unit (UR17JS01) «Sport Performance, Health & Society», Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", 2010 Tunis, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph17217877']
2131,33121204,A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study.,"Rehabilitation has been shown to improve functional outcomes following total knee replacement (TKR). However, its delivery and associated costs are highly variable. The authors have developed and previously validated the accuracy of a remote (wearable) rehabilitation monitoring platform ( interACTION ). The present study's objective was to assess the feasibility of utilizing  interACTION  for the remote management of rehabilitation after TKR and to determine a preliminary estimate of the effects of the  interACTION  system on the value of rehabilitation. Specifically, we tested post-operative outpatient rehabilitation supplemented with  interACTION  (n = 13) by comparing it to a standard post-operative outpatient rehabilitation program (n = 12) using a randomized design. Attrition rates were relatively low and not significantly different between groups, indicating that participants found both interventions acceptable. A small (not statistically significant) decrease in the number of physical therapy visits was observed in the  interACTION  Group, therefore no significant difference in total cost could be observed. All patients and physical therapists in the  interACTION  Group indicated that they would use the system again in the future. Therefore, the next steps are to address the concerns identified in this pilot study and to expand the platform to include behavioral change strategies prior to conducting a full-scale randomized controlled trial. Trial registration: ClinicalTrials.gov NCT02646761 "" interACTION : A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA"" 6 January 2016.",2020,"A small (not statistically significant) decrease in the number of physical therapy visits was observed in the  interACTION  Group, therefore no significant difference in total cost could be observed.","['Remote Rehabilitation Following a Total Knee Replacement', 'Remote Rehabilitation Following TKA"" 6 January 2016']",['operative outpatient rehabilitation supplemented with  interACTION  (n = 13) by comparing it to a standard post-operative outpatient rehabilitation program'],"['total cost', 'number of physical therapy visits', 'Attrition rates']","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.0284462,"A small (not statistically significant) decrease in the number of physical therapy visits was observed in the  interACTION  Group, therefore no significant difference in total cost could be observed.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Bell', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Chukwudi', 'Initials': 'C', 'LastName': 'Onyeukwu', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Clair N', 'Initials': 'CN', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Adrianna', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Devito Dabbs', 'Affiliation': 'Department of Acute and Tertiary Care, School of Nursing, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Popchak', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Lynch', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Irrgang', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McClincy', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.'}]","Sensors (Basel, Switzerland)",['10.3390/s20216118']
2132,30923187,Risk assessment in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.,"BACKGROUND


Current pulmonary hypertension treatment guidelines recommend use of a risk stratification model encompassing a range of parameters, allowing patients to be categorised as low, intermediate or high risk. Three abbreviated versions of this risk stratification model were previously evaluated in patients with pulmonary arterial hypertension (PAH) in the French, Swedish and COMPERA registries. Our objective was to investigate the three abbreviated risk stratification methods for patients with mostly prevalent PAH and chronic thromboembolic pulmonary hypertension (CTEPH), in patients from the PATENT-1/2 and CHEST-1/2 studies of riociguat.
METHODS


Risk was assessed at baseline and at follow-up in PATENT-1 and CHEST-1. Survival and clinical worsening-free survival were assessed in patients in each risk group/strata.
RESULTS


With all three methods, riociguat improved risk group/strata in patients with PAH after 12 weeks. The French non-invasive and Swedish/COMPERA methods discriminated prognosis for survival and clinical worsening-free survival at both baseline and follow-up. Furthermore, patients achieving one or more low-risk criteria or a low-risk stratum at follow-up had a significantly reduced risk of death and clinical worsening compared with patients achieving no low-risk criteria or an intermediate-risk stratum. Similar results were obtained in patients with inoperable or persistent/recurrent CTEPH.
CONCLUSIONS


This analysis confirms and extends the results of the registry analyses, supporting the value of goal-oriented treatment in PAH. Further assessment of these methods in patients with CTEPH is warranted.",2019,The French non-invasive and Swedish/COMPERA methods discriminated prognosis for survival and clinical worsening-free survival at both baseline and follow-up.,"['pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension', 'patients with mostly prevalent PAH and chronic thromboembolic pulmonary hypertension (CTEPH', 'patients with pulmonary arterial hypertension (PAH) in the French, Swedish and COMPERA registries', 'patients with inoperable or persistent/recurrent CTEPH', 'patients with CTEPH']",[],"['survival and clinical worsening-free survival', 'Survival and clinical worsening-free survival', 'risk of death and clinical worsening']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0560142,The French non-invasive and Swedish/COMPERA methods discriminated prognosis for survival and clinical worsening-free survival at both baseline and follow-up.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'University Paris-Sud, Faculté de Médecine, Université Paris Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Harrison W', 'Initials': 'HW', 'LastName': 'Farber', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'University of Giessen and Marburg Lung Center, Member of the German Center for Lung Research (DZL), Giessen, Germany.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Benza', 'Affiliation': 'Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Busse', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meier', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Clinic for Respiratory Medicine, Hannover Medical School, Member of the German Center for Lung Research (DZL), Hannover, Germany.'}]",The European respiratory journal,['10.1183/13993003.02004-2018']
2133,31026118,Additive value of diffusion-weighted MRI in the I-SPY 2 TRIAL.,"BACKGROUND


The change in apparent diffusion coefficient (ADC) measured from diffusion-weighted imaging (DWI) has been shown to be predictive of pathologic complete response (pCR) for patients with locally invasive breast cancer undergoing neoadjuvant chemotherapy.
PURPOSE


To investigate the additive value of tumor ADC in a multicenter clinical trial setting.
STUDY TYPE


Retrospective analysis of multicenter prospective data.
POPULATION


In all, 415 patients who enrolled in the I-SPY 2 TRIAL from 2010 to 2014 were included.
FIELD STRENGTH/SEQUENCE


1.5T or 3T MRI system using a fat-suppressed single-shot echo planar imaging sequence with b-values of 0 and 800 s/mm2 for DWI, followed by a T1-weighted sequence for dynamic contrast-enhanced MRI (DCE-MRI) performed at pre-NAC (T0), after 3 weeks of NAC (T1), mid-NAC (T2), and post-NAC (T3).
ASSESSMENT


Functional tumor volume and tumor ADC were measured at each MRI exam; pCR measured at surgery was assessed as the binary outcome. Breast cancer subtype was defined by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status.
STATISTICAL TESTS


A logistic regression model was used to evaluate associations between MRI predictors with pCR. The cross-validated area under the curve (AUC) was calculated to assess the predictive performance of the model with and without ADC.
RESULTS


In all, 354 patients (128 HR+/HER2-, 60 HR+/HER2+, 34 HR-/HER2+, 132 HR-/HER2-) were included in the analysis. In the full cohort, adding ADC predictors increased the AUC from 0.76 to 0.78 at mid-NAC and from 0.76 to 0.81 at post-NAC. In HR/HER2 subtypes, the AUC increased from 0.52 to 0.65 at pre-NAC for HR+/HER2-, from 0.67 to 0.73 at mid-NAC and from 0.72 to 0.76 at post-NAC for HR+/HER2+, from 0.71 to 0.81 at post-NAC for triple negatives.
DATA CONCLUSION


The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
LEVEL OF EVIDENCE


2 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2019;50:1742-1753.",2019,"The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
","['patients with locally invasive breast cancer undergoing neoadjuvant chemotherapy', '415 patients who enrolled in the I-SPY 2 TRIAL from 2010 to 2014 were included', '354 patients (128 HR+/HER2-, 60 HR+/HER2+, 34 HR-/HER2+, 132 HR-/HER2-) were included in the analysis']",[],"['Functional tumor volume and tumor ADC', 'cross-validated area under the curve (AUC', 'AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",415.0,0.080188,"The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Newitt', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Wilmes', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ella F', 'Initials': 'EF', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Arasu', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'La Yun', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Savannah C', 'Initials': 'SC', 'LastName': 'Partridge', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kornak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Department of Surgery, University of California, San Francisco, California, USA.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26770']
2134,33120766,"Dexmedetomidine-remifentanil vs propofol-remifentanil for monitored anesthesia care during hysteroscopy: Randomized, single-blind, controlled trial.","BACKGROUND


Although dexmedetomidine has been used as either the anesthetic agent for light sedation or as an adjunct to other sedatives, no study has investigated the usefulness of dexmedetomidine as the main sedative agent for invasive and painful procedures. The purpose of this study was to compare the safety of dexmedetomidine-remifentanil and propofol-remifentanil during monitored anesthesia care (MAC) for hysteroscopy.
METHODS


Female patients undergoing hysteroscopy were randomly assigned to either the dexmedetomidine (group D) or the propofol group (group P). The study drug (0.6 ml/kg; dexmedetomidine 2 μg/ml or propofol 4 mg/ml) was loaded for 10 minutes followed by 0.1 to 0.5 ml/kg/hour to maintain a bispectral index of 60 to 80 during the procedure. In both groups, remifentanil was infused using a target-controlled-infusion system with a target concentration of 2 ng/ml and titrated during the procedure. The incidence rates of intraoperative respiratory depression in both groups were compared. Postoperative pain and patients satisfaction were also compared.
RESULTS


A total of 69 female patients were included in this study. Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively). Postoperative pain and patients satisfaction score did not differ between the groups.
CONCLUSION


The combination of dexmedetomidine-remifentanil can reduce the incidence of respiratory depression without increasing hemodynamic complications compared with propofol-remifentanil for MAC during hysteroscopy.",2020,"Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively).","['Female patients undergoing hysteroscopy', 'monitored anesthesia care during hysteroscopy', '69 female patients']","['dexmedetomidine-remifentanil and propofol-remifentanil', 'propofol-remifentanil', 'propofol', 'Dexmedetomidine', 'dexmedetomidine', 'remifentanil', 'dexmedetomidine-remifentanil', 'Dexmedetomidine-remifentanil vs propofol-remifentanil', 'dexmedetomidine 2\u200aμg/ml or propofol']","['Postoperative pain and patients satisfaction', 'incidence rates of intraoperative respiratory depression', 'Postoperative pain and patients satisfaction score', 'incidence of respiratory depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",69.0,0.108515,"Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively).","[{'ForeName': 'Seongjoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Soo-Lyoen', 'Initials': 'SL', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Francis Sahngun', 'Initials': 'FS', 'LastName': 'Nahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Do', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}]",Medicine,['10.1097/MD.0000000000022712']
2135,33120774,Efficacy of a single injection compared with triple injections using a costoclavicular approach for infraclavicular brachial plexus block during forearm and hand surgery: A randomized controlled trial.,"OBJECTIVES


It was recently proposed that a costoclavicular (CC) approach can be used in ultrasound (US)-guided infraclavicular brachial plexus block (BPB). In this study, we hypothesized that triple injections in each of the 3 cords in the CC space would result in a greater spread in the 4 major terminal nerves of the brachial plexus than a single injection in the CC space without increasing the local anesthetic (LA) volume.
METHODS


Sixty-eight patients who underwent upper extremity surgery randomly received either a single injection (SI group, n = 34) or a triple injection (TI group, n = 34) using the CC approach. Ten milliliters of 2% lidocaine, 10 mL of 0.75% ropivacaine, and 5 mL of normal saline were used for BPB in each group (total 25 mL). Sensory-motor blockade of the ipsilateral median, radial, ulnar, and musculocutaneous nerves was assessed by a blinded observer at 5 minutes intervals for 30 minutes immediately after LA administration.
RESULTS


Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004). But there was no significant difference in the anesthesia grade between the 2 groups (P = .262). The performance time was similar in the 2 groups (3.0 ± 0.9 minutes in the SI group vs 3.2 ± 1.2 minutes in the TI group, respectively; P = .54).
DISCUSSION


The TI of CC approach increased the consistency of US-guided infraclavicular BPB in terms of the rate of blocking all 4 nerves without increasing the procedure time despite administering the same volume of the LA.",2020,"Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004).","['Sixty-eight patients who underwent upper extremity surgery randomly received either a', 'infraclavicular brachial plexus block during forearm and hand surgery']","['costoclavicular approach', 'lidocaine, 10\u200amL of 0.75% ropivacaine, and 5\u200amL of normal saline', 'single injection (SI group, n\u200a=\u200a34) or a triple injection (TI group, n\u200a=\u200a34) using the CC approach']","['performance time', 'anesthesia grade', 'local anesthetic (LA) volume', 'Sensory-motor blockade of the ipsilateral median, radial, ulnar, and musculocutaneous nerves', 'blockage rate of all 4 nerves']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0026855', 'cui_str': 'Structure of musculocutaneous nerve'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]",68.0,0.0500867,"Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004).","[{'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon.'}, {'ForeName': 'Doo Yeon', 'Initials': 'DY', 'LastName': 'Go', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Sung Uk', 'Initials': 'SU', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Yun Suk', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, JeJu National University College of Medicine, Jeju Hospital, Jeju, Republic of Korea.'}, {'ForeName': 'Hyeon Ju', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}]",Medicine,['10.1097/MD.0000000000022739']
2136,33120816,Clinical experience of biliary T tube of immobilization of peri-pin membrane in tibial Gustilo III fracture treated with vacuum sealant drainage combined with an external fixator.,"OBJECTIVE


To determine the effects of an improved method of peri-pin membrane immobilization in tibial Gustilo type III fracture treated with vacuum sealant drainage (VSD) combined with an external fixator.
METHOD


A biliary T tube of suitable size and type was cut into a certain long arm and cross arm which wrapping around a pin to improving traditional peri-pin VSD method. Eighty-six cases of Gustilo type III tibial fracture admitted from January 2016 to December 2019 were prospectively treated, of which 43 cases were treated using a traditional method of VSD (Traditional group) and 43 cases in which VSD treatment was enhanced (Improved group). The 2 groups were compared by some clinical indexes. Statistical software was then used for data analysis. P < .05 was considered statistically significant.
RESULTS


Compared with the Traditional group, the improved group significantly reduced granulation tissue growth time (day) (7.35 + 2.59 vs 11.14 + 2.54, P < .05), antibiotic use time (day) (6.67 + 2.39 vs 8.70 + 1.98, P < .05), operation time (min) (72.44 + 16.79 vs 85.47 + 17.44, P < .05) duration of hospital stay (day) (18.23 + 5.04 vs 21.53 + 4.79, P < .05), wound closure time (day) (9.23 + 2.69 vs 14.19 + 2.67, P < .05), air leakage around the fixed needle (3/43 vs 16/43, P < .05) and postoperative pain score (P < .05). Meanwhile, the white blood cell, C-reactive protein, erythrocyte sedimentation rate of 1 week and 2 weeks post-operation were also reduced after adopting the improved method (P < .05). The difference in infection around the fixation pin and pin loosening between the 2 groups was not significant.
CONCLUSION


The biliary T tube was effctive in improving VSD combined with external fixation for the treatment of tibial Gustilo type III fractures. The materials are easy to obtain and straightforward to use and so is worthy of clinical promotion.",2020,The biliary T tube was effctive in improving VSD combined with external fixation for the treatment of tibial Gustilo type III fractures.,"['tibial Gustilo type III fracture treated with', 'tibial Gustilo III fracture treated with', 'Eighty-six cases of Gustilo type III tibial fracture admitted from January 2016 to December 2019']","['vacuum sealant drainage (VSD) combined with an external fixator', 'biliary T tube of immobilization of peri-pin membrane', 'peri-pin membrane immobilization', 'VSD combined with external fixation', 'vacuum sealant drainage combined with an external fixator']","['white blood cell, C-reactive protein, erythrocyte sedimentation rate', 'wound closure time', 'infection around the fixation pin and pin loosening', 'granulation tissue growth time', 'duration of hospital stay', 'operation time', 'antibiotic use time', 'air leakage around the fixed needle', 'postoperative pain score']","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079321', 'cui_str': 'External fixation device'}, {'cui': 'C0444239', 'cui_str': 'Biliary T-tube'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.0139406,The biliary T tube was effctive in improving VSD combined with external fixation for the treatment of tibial Gustilo type III fractures.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': ""Department of Orthopedics Surgery, Suichang branch of The Second Affiliated Hospital, Zhejiang University School of Medicine (Suichang County People's Hospital in Zhejiang Province), Suichang, LiShui.""}, {'ForeName': 'Shufeng', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Department of Orthopedics Surgery, Suichang branch of The Second Affiliated Hospital, Zhejiang University School of Medicine (Suichang County People's Hospital in Zhejiang Province), Suichang, LiShui.""}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopedics Surgery, Suichang branch of The Second Affiliated Hospital, Zhejiang University School of Medicine (Suichang County People's Hospital in Zhejiang Province), Suichang, LiShui.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Medicine,['10.1097/MD.0000000000022846']
2137,33120822,Moxibustion combined with characteristic lifestyle intervention of Traditional Chinese Medicine in the treatment of abdominal obesity: A study protocol for a randomized controlled trial.,"BACKGROUND


Abdominal obesity occurs when excessive visceral and subcutaneous fat is built up around the abdomen and stomach, which negatively impacts human health. Moxibustion, arose from Traditional Chinese Medicine (TCM), has been widely applied in the treatment of abdominal obesity. Several studies have shown the positive effects of moxibustion in prevention and treatment of endocrine issues and excess body weight. In this context, our study aims to examine the safety and efficacy of the combination of moxibustion and characteristic lifestyle intervention of TCM in the treatment of abdominal obesity.
METHODS/DESIGN


This study will be a multicenter, randomized, controlled trial conducted from September 2020 to January 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio. The intervention group will receive moxibustion combined with characteristic lifestyle intervention of TCM; the other group will receive moxibustion combined with lifestyle intervention; the control group will receive lifestyle intervention only. Eight-week moxibustion sessions will be provided to participants assigned to the 2 intervention groups. The characteristic lifestyle intervention of TCM will also last 8 weeks, whereas the lifestyle intervention will last 12 weeks including 8-week treatment period, 4-week follow-up period. The primary outcome is the waist circumference measured by a tape measure. The secondary outcomes include obesity-related indicators, serum biochemical indexs, blood pressure, conversion score of physical symptoms, and measurement of the scale. Adverse events will be recorded during the treatment and follow-up period.
DISCUSSION


The results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of TCM in patients with abdominal obesity.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04501198, Registered on 9 June 2020.",2020,Several studies have shown the positive effects of moxibustion in prevention and treatment of endocrine issues and excess body weight.,"['from September 2020 to January 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria', 'patients with abdominal obesity', 'abdominal obesity']","['Moxibustion combined with characteristic lifestyle intervention of Traditional Chinese Medicine', 'TCM', 'moxibustion and characteristic lifestyle intervention of TCM', 'moxibustion combined with lifestyle intervention; the control group will receive lifestyle intervention only', 'moxibustion combined with characteristic lifestyle intervention of TCM', 'Moxibustion, arose from Traditional Chinese Medicine (TCM']","['waist circumference', 'obesity-related indicators, serum biochemical indexs, blood pressure, conversion score of physical symptoms, and measurement of the scale', 'Adverse events', 'safety and efficacy']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332285', 'cui_str': 'In'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0666522,Several studies have shown the positive effects of moxibustion in prevention and treatment of endocrine issues and excess body weight.,"[{'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Zhou', 'Affiliation': 'Department of rheumatology, Shanxi Provincial Hospital of Traditional Chinese Medicine, Shanxi.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Acupuncture, Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Shenzhen.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Acupuncture, Xiangyang Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Zhong-Yu', 'Initials': 'ZY', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion.'}]",Medicine,['10.1097/MD.0000000000022855']
2138,33120826,Implementation of a clinical nursing pathway for percutaneous coronary intervention: A randomized controlled trial protocol.,"BACKGROUND


Acute myocardial infarction is a very common disease in the emergency room. Emergency percutaneous coronary intervention (PCI) is the first choice to open infarct-related artery in time to regain the active blood flow of myocardial tissue. Clinical nursing pathway (CNP), namely clinical project, is an original nursing mode with good quality, outstanding efficiency, and low treatment spending, so it has attracted more and more attention. However, few studies have reported the implementation of a CNP in PCIs. The purpose of the protocol is to assess the impact of CNP on the clinical efficacy of transradial emergency PCI.
METHODS


This is a randomized controlled, single center trial which will be implemented from January 2021 to June 2021. Hundred samples diagnosed with acute myocardial infarction will be included in this study. It was authorized via the Ethics Committee of Changshan County People's Hospital (CCPH002348). Patients are assigned to the following groups: control group, given normal routine care; CNP group, treated with CNP plan. The time from door to balloon, hospitalization expenses, length of stay, postoperative complications, patients' satisfaction with treatment are compared and analyzed. All data are collected and analyzed by Social Sciences software version 21.0 (SPSS, Inc., Chicago, IL) program.
RESULTS


Differences of clinical outcomes between groups ().
CONCLUSION


This original evidence-based nursing model can be used as the foundation for further research.
TRIAL REGISTRATION NUMBER


researchregistry6030.",2020,"The time from door to balloon, hospitalization expenses, length of stay, postoperative complications, patients' satisfaction with treatment are compared and analyzed.","['January 2021 to June 2021', 'Hundred samples diagnosed with acute myocardial infarction']","['control group, given normal routine care; CNP group, treated with CNP plan', 'percutaneous coronary intervention', 'CNP', 'Emergency percutaneous coronary intervention (PCI']","[""time from door to balloon, hospitalization expenses, length of stay, postoperative complications, patients' satisfaction""]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1532297', 'cui_str': 'Emergency percutaneous coronary intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0701629,"The time from door to balloon, hospitalization expenses, length of stay, postoperative complications, patients' satisfaction with treatment are compared and analyzed.","[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Changshan County People's Hospital, Zhejiang, China.""}]",Medicine,['10.1097/MD.0000000000022866']
2139,33120838,"Comparison between anteroposterior and oblique ""Scotty dog"" approach during S1 transforaminal epidural steroid injection: A randomized controlled trial.","BACKGROUND


Traditionally, S1 transforaminal epidural steroid injection (TFESI) has been performed using an anteroposterior (AP) fluoroscopic view. In 2007, the oblique ""Scotty dog"" (OS) approach was introduced as an alternative technique. We compared passage time of the needle into S1 foramen (Tf) between the anteroposterior (AP) and oblique ""Scotty dog"" (OS) approach during S1 TFESI.
METHODS


In this prospective randomized controlled trial, seventy patients scheduled S1 TFESI were randomly allocated into AP or OS groups. In the AP group, a slight cephalad-caudad tilt was used. In the OS group, the C-arm was rotated ipsilateral oblique degrees to view the S1 Scotty dog. Both groups received injection of steroid mixed with local anesthetics. We measured the passage time of the needle into S1 foramen (Tf), primary outcome, and total procedure time (Tt) between the groups. We also recorded presence of intravascular injection, patients-assessed pain relief for one month and complications.
RESULTS


The Tf and Tt were shorter in the OS than in the AP group (24.4 ± 24.0 s vs 47. 8 ± 53.2seconds; 93.3 ± 35.0 seconds vs 160.0 ± 98.7 seconds, P < .001, both). Incidence of intravascular injection (AP, 8 [22.8%]; OS, 4 [11.4%], P = .205), pain score, and complication rates were not statistically different between the two groups. In logistic regression analysis, the body mass index (BMI) was a risk factor for longer Tt (odds ratio [OR] = 1.27, 95% CI: 1.02-1.58, P = .030).
CONCLUSION


The passage time of the needle into S1 foramen was shorter in OS approach and the OS approach reduced the procedure time compared with the AP approach during S1 TFESI. The practitioners should note that procedure time can be prolonged in obese patients.",2020,The passage time of the needle into S1 foramen was shorter in OS approach and the OS approach reduced the procedure time compared with the AP approach during S1 TFESI.,"['obese patients', 'seventy patients scheduled S1 TFESI']","['anteroposterior and oblique ""Scotty dog"" approach', 'steroid mixed with local anesthetics']","['passage time of the needle into S1 foramen (Tf), primary outcome, and total procedure time (Tt', 'body mass index (BMI', 'pain relief', 'passage time of the needle into S1 foramen', 'procedure time', 'Incidence of intravascular injection', 'pain score, and complication rates']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}]","[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0189621', 'cui_str': 'Injection of cardiovascular system'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",70.0,0.0409512,The passage time of the needle into S1 foramen was shorter in OS approach and the OS approach reduced the procedure time compared with the AP approach during S1 TFESI.,"[{'ForeName': 'Ryung A', 'Initials': 'RA', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woo Seog', 'Initials': 'WS', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Sehee', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hyeon Sook', 'Initials': 'HS', 'LastName': 'Jee', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Yunghun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022895']
2140,33121297,"Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial.","The present study was conducted to compare the effects of high polyphenol extra-virgin olive oil (EVOO) with low polyphenol refined olive oil (ROO) on some cardiovascular risk factors in patients undergoing coronary angiography. In a randomised, controlled, parallel-arm, clinical trial, 40 patients with at least one classic cardiovascular risk factor who referred to coronary angiography were randomly allocated to two groups and receied 25 mL EVOO or ROO daily for 6 weeks. Plasma LDL-cholesterol significantly reduced in EVOO group (-9.52 ± 20.44 vs 8.68 ± 18.77 mg/dL,  p  = .007 for EVOO and ROO respectively). EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively). Daily consumption of polyphenol-rich EVOO in subjects who have been under medical treatment with risk-reducing agents could additionally improve LDL-C and selected inflammatory markers.  Trial Registration Number:  NCT03796780.",2020,"EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively).","['patients undergoing coronary angiography', 'subjects who have been under medical treatment with risk-reducing agents could additionally improve LDL-C and selected inflammatory markers', '40 patients with at least one classic cardiovascular risk factor who referred to coronary angiography']","['high polyphenol extra-virgin olive oil (EVOO) with low polyphenol refined olive oil (ROO', 'polyphenol-rich extra-virgin olive oil', 'polyphenol-rich EVOO']","['cardiovascular risk factors', 'Plasma LDL-cholesterol', 'plasma CRP', 'lipid profile and inflammatory biomarkers', 'ex-vivo whole blood LPS-stimulated IL-10 production']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376446', 'cui_str': 'Reductants'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",40.0,0.252296,"EVOO resulted in a significant reduction in plasma CRP (-0.40 ± 0.52 vs 0.007 ± 0.42 mg/L,  p  = .01 for EVOO and ROO respectively) and increased ex-vivo whole blood LPS-stimulated IL-10 production (12.13 ± 33.64 vs -17.47 ± 49.04 pg/mL,  p  = .035 for EVOO and ROO respectively).","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Khandouzi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1841123']
2141,33121341,Developmental Moderators of a Single-Session Incremental Theory of Personality Intervention on Aggressive Behavior.,"This study examines two indicators of developmental level (testosterone and grade) as moderators of the effects of a single-session incremental theory of personality intervention on both traditional and online aggressive behaviors. A sample of 535 Spanish adolescents (boys: 50%; age: 12-17 years) participated in a double-blind, randomized controlled trial. Participants were randomized to receive the incremental theory of personality intervention or an alternative educational control condition. The intervention consisted of teaching the belief that people can change. Aggressive behaviors were measured at baseline, one-week posttest, and six-month and twelve-month follow-ups. Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration. Grade moderated the effectiveness of the intervention on both forms of aggressive behavior, being only effective in Grade 8. Overall, the findings indicate that some preventative interventions can be more effective among adolescents with lower levels of development.",2020,"Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration.",['535 Spanish adolescents (boys: 50%; age: 12-17 years'],"['Personality Intervention', 'incremental theory of personality intervention or an alternative educational control condition']","['Aggressive behaviors', 'Aggressive Behavior', 'online aggressive behavior']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",535.0,0.0674675,"Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calvete', 'Affiliation': 'University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Liria', 'Initials': 'L', 'LastName': 'Fernández-González', 'Affiliation': 'University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Ainara', 'Initials': 'A', 'LastName': 'Echezarraga', 'Affiliation': 'University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Orue', 'Affiliation': 'University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muga', 'Affiliation': 'IMQ analisis, Zamudio, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Longa', 'Affiliation': 'IMQ analisis, Zamudio, Spain.'}]",Journal of interpersonal violence,['10.1177/0886260520969234']
2142,33121346,"A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.","Respiratory Syncytial Virus (RSV) causes lower respiratory tract infections that can be severe and sometimes fatal. The risk for severe RSV infection is highest in infants and older adults. A safe and effective RSV vaccine for older adults represents a serious unmet medical need due to higher morbidity and mortality in this age group. In this randomized, partially double-blind, placebo-controlled, phase 1 dose-escalation study, we evaluated the safety, tolerability and immunogenicity of an investigational messenger ribonucleic acid (mRNA) vaccine encoding the RSV fusion protein (F) stabilized in the prefusion conformation. The study was conducted in healthy younger adults (ages ≥18 and ≤49 years) and healthy older adults (ages ≥60 and ≤79 years). Participants received mRNA-1777 (V171) or placebo as a single intramuscular dose. For each dose level, three sentinel participants were administered open-label mRNA-1777 (V171). Seventy-two younger adults were randomized and administered 25, 100, or 200 µg mRNA-1777 (V171) or placebo, and 107 older adults were randomized and administered 25, 100, 200 or 300 µg mRNA-1777 (V171) or placebo. Primary objectives were safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity. All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported. Immunization with mRNA-1777 (V171) elicited a humoral immune response as measured by increases in RSV neutralizing antibody titers, serum antibody titers to RSV prefusion F protein, D25 competing antibody titers to RSV prefusion F protein, and cell-mediated immune responses to RSV-F peptides.",2020,All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported.,"['older adults', 'healthy younger adults (ages ≥18 and ≤49\xa0years) and healthy older adults (ages ≥60 and ≤79\xa0years', 'healthy younger and older adults', ' and 107 older adults', 'infants and older adults', 'Seventy-two younger adults']","['mRNA-based RSV prefusion F protein vaccine', 'investigational messenger ribonucleic acid (mRNA) vaccine', 'placebo', 'mRNA-1777 (V171) or placebo']","['tolerated and no serious adverse events', 'safety, tolerability and immunogenicity', 'safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity', 'safety and immunogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",3.0,0.190719,All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported.,"[{'ForeName': 'Antonios O', 'Initials': 'AO', 'LastName': 'Aliprantis', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'QPharm , Herston, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Farinola', 'Affiliation': 'CMAX , Adelaide, Australia.'}, {'ForeName': 'Radha A', 'Initials': 'RA', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Sachs', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'Swenson', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Cox', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Spellman', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Colleen J', 'Initials': 'CJ', 'LastName': 'Winstead', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Eseng', 'Initials': 'E', 'LastName': 'Lai', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Zaks', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Espeseth', 'Affiliation': 'Merck & Co., Inc ., Kenilworth, NJ, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Panther', 'Affiliation': 'Moderna, Inc ., Cambridge, MA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1829899']
2143,33121379,Deep Learning to Predict Energy Expenditure and Activity Intensity in Free Living Conditions using Wrist-specific Accelerometry.,"Wrist-worn accelerometers are more comfortable and yield greater compliance than hip-worn devices, making them attractive for free-living activity assessments. However, intricate wrist movements may require more complex predictive models than those applied to hip-worn devices. This study developed a novel deep learning method that predicts energy expenditure and physical activity intensity of adults using wrist-specific accelerometry. Triaxial accelerometers were worn by 119 participants on their wrist and hip for two weeks during waking hours. A deep learning model was developed from week 1 data of 60 participants and tested using week 2 data for: (i) the remaining 59 participants (Group UT), and (ii) participants used for training (Group TR). Estimates of physical activity were compared to a reference hip-specific method. Moderate-to-vigorous physical activity predicted by the wrist-model was not different to the reference method for participants in Group UT (5.9±3.1 vs.  6.3±3.3 hour/week) and Group TR (6.9±3.7  vs.  7.2±4.2 hour/week). At 60-s epoch level, energy expenditure predicted by the wrist-model on Group UT was strongly correlated with the reference method (r=0.86, 95%CI: 0.84-0.87) and closely predicted activity intensity (83.7%, 95%CI: 80.9-86.5%). The deep learning method has application for wrist-worn accelerometry in free-living adults.",2020,Moderate-to-vigorous physical activity predicted by the wrist-model was not different to the reference method for participants in Group UT (,"['free-living adults', 'adults using wrist-specific accelerometry']",[],"['activity intensity', 'Moderate-to-vigorous physical activity']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",60.0,0.0267141,Moderate-to-vigorous physical activity predicted by the wrist-model was not different to the reference method for participants in Group UT (,"[{'ForeName': 'Rashmika', 'Initials': 'R', 'LastName': 'Nawaratne', 'Affiliation': 'Research Centre for Data Analytics and Cognition, School of Business, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Damminda', 'Initials': 'D', 'LastName': 'Alahakoon', 'Affiliation': 'Research Centre for Data Analytics and Cognition, School of Business, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Daswin', 'Initials': 'D', 'LastName': 'De Silva', 'Affiliation': 'Research Centre for Data Analytics and Cognition, School of Business, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': ""O'Halloran"", 'Affiliation': 'School of Psychology and Public Health, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Alexander Hk', 'Initials': 'AH', 'LastName': 'Montoye', 'Affiliation': 'Research in Applied Physiology Laboratory, Integrative Physiology and Health Science Department, Alma College , Alma, MI, USA.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'Staley', 'Affiliation': 'Centre for Sport and Social Impact, School of Business, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nicholson', 'Affiliation': 'Centre for Sport and Social Impact, School of Business, La Trobe University , Bundoora, Australia.'}, {'ForeName': 'Michael Ic', 'Initials': 'MI', 'LastName': 'Kingsley', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University , Bundoora, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1841394']
2144,33121501,Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER.,"BACKGROUND


A number of single-inhaler triple therapies are being developed for asthma, including the extrafine formulation of beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G). Given asthma is a heterogenous disease, we investigated whether the clinical response to the addition of the long-acting muscarinic antagonist component within inhaled triple therapy was impacted by a range of clinical characteristics.
METHODS


These were pre-specified and post-hoc sub-group analyses of TRIMARAN and TRIGGER, which were double-blind, 52-week studies comparing medium-strength (100/6/10 µg; TRIMARAN) and high-strength (200/6/10 µg; TRIGGER) BDP/FF/G with the respective BDP/FF strengths in adults with uncontrolled asthma and a history of ≥ 1 exacerbation. Co-primary endpoints were pre-dose forced expiratory volume in 1 s (FEV 1 ) at Week 26 and the rate of moderate-to-severe exacerbations over 52 weeks. Key secondary endpoints: peak FEV 1  at Week 26 and average morning peak expiratory flow over the first 26 weeks in each study, and severe exacerbation rate over 52 weeks (pooled data).
RESULTS


Baseline clinical characteristics (pre-specified analyses) had no consistent effect on the lung function improvements with BDP/FF/G. For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF. In post-hoc analyses with patients sub-grouped by screening blood eosinophil values, in TRIMARAN the greatest relative effect of BDP/FF/G versus BDP/FF on the lung function endpoints was in the ≤ 300 cells/µL group; in TRIGGER, eosinophil levels did not markedly influence the relative efficacy of BDP/FF/G versus BDP/FF. Eosinophil levels did not influence relative efficacy on moderate-to-severe or severe exacerbations.
CONCLUSION


Overall, the relative efficacy of extrafine BDP/FF/G versus BDP/FF was not influenced by a range of clinical characteristics. However, some patient sub-groups gained additional benefit from BDP/FF/G for certain endpoints. In particular, for exacerbations the relative efficacy of BDP/FF/G was greater in more reversible patients. Trial registration ClinicalTrials.gov: TRIMARAN, NCT02676076 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676076?term=NCT02676076&draw=2&rank=1 ,); TRIGGER, NCT02676089 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676089?term=NCT02676089&draw=2&rank=1 ).",2020,"For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF.","['asthma', 'adults with uncontrolled asthma and a history of\u2009≥\u20091 exacerbation']","['beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G', 'inhaled extrafine triple therapy', 'extrafine BDP/FF/G versus BDP/FF']","['rate of moderate-to-severe exacerbations', 'severe exacerbation rate', 'screening blood eosinophil values', 'peak FEV 1  at Week 26 and average morning peak expiratory flow', 'Eosinophil levels', 'pre-dose forced expiratory volume in 1\xa0s (FEV 1 ']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}]",,0.568295,"For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Johann Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Zentrum Für Innere Medizin, Abteilung Für Pneumologie, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Center of Personalized Medicine: Asthma and Allergy, Humanitas University and Research Hospital IRCCS, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vele', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Kots', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, University of Ferrara, University Hospital S.Anna, Ferrara, Italy.'}]",Respiratory research,['10.1186/s12931-020-01558-y']
2145,33121503,Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa-study protocol for a mixed-methods study including a randomised controlled trial.,"BACKGROUND


HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation.
METHODS


We propose a mixed-methods study amongst young people aged 13-24 years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13-24 years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2 days, and with the final dose given either 6 or 20 h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue.
DISCUSSION


This study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03986970 . Registered on 14 June 2019.",2020,"BACKGROUND


HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake.","['young people in sub-Saharan Africa', 'young people in South Africa, Uganda and Zimbabwe', 'young people aged 13-24\u2009years', '144 amongst HIV-negative uncircumcised men aged 13-24\u2009years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms']","['FTC-TDF or FTC-TAF', 'Combined HIV Adolescent Prevention Study (CHAPS', 'Combined HIV Adolescent PrEP and Prevention Study (CHAPS', 'PrEP treatment (FTC-TDF vs FTC-TAF', 'HIV pre-exposure prophylaxis regimens', 'pre-exposure prophylaxis (PrEP']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0282021', 'cui_str': 'Uncircumcised'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],,0.0698807,"BACKGROUND


HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nash', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dietrich', 'Affiliation': 'University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'MRC/UVRI Uganda Research Unit On Aids, Entebbe, Uganda.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Herrera', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""O'Hagan"", 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Else', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chiodi', 'Affiliation': 'Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shattock', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'L-G', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stranix-Chibanda', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'MRC/UVRI Uganda Research Unit On Aids, Entebbe, Uganda.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'London School of Hygiene, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martinson', 'Affiliation': 'University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': ""King's College London, London, UK. julie.fox@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04760-x']
2146,33121536,Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol.,"BACKGROUND


Screening for colorectal cancer (CRC) not only detects disease early when treatment is more effective but also prevents cancer by finding and removing precancerous polyps. Because many of our nation's most disadvantaged and vulnerable individuals obtain health care at federally qualified health centers, these centers play a significant role in increasing CRC screening among the most vulnerable populations. Furthermore, the full benefits of cancer screenings must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this study is to implement a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care in federally qualified health centers, as well as simultaneously to observe and to gather information on the implementation process to improve the adoption, implementation, and sustainment of the intervention. The multilevel intervention will target three different levels of influences: organization, provider, and individual. It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
METHODS


This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four clusters of clinics from four different FQHC systems. In the first phase, there will be a 3-month waiting period during which no intervention components will be implemented. After the 3-month waiting period, we will randomize two clusters to cross from the control to the intervention and the remaining two clusters to follow 3 months later. All clusters will stay at the same phase for 9 months, followed by a 3-month transition period, and then cross over to the next phase.
DISCUSSION


There is a pressing need to reduce disparities in CRC outcomes, especially among racial/ethnic minority populations and among populations who live in poverty. Single-level interventions are often insufficient to lead to sustainable changes. Multilevel interventions, which target two or more levels of changes, are needed to address multilevel contextual influences simultaneously. Multilevel interventions with multiple components will affect not only the desired outcomes but also each other. How to take advantage of multilevel interventions and how to implement such interventions and evaluate their effectiveness are the ultimate goals of this study.
TRIAL REGISTRATION


This protocol is registered at clinicaltrials.gov ( NCT04514341 ) on 14 August 2020.",2020,"It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
","['four clusters of clinics from four different FQHC systems', '14 August 2020']",['multilevel intervention'],[],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0284914,"It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Blasé', 'Initials': 'B', 'LastName': 'Polite', 'Affiliation': 'University of Chicago Medicine Hematology and Oncology, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago Biological Sciences, 5841\u2009S. Maryland Ave, Rm W-254, MC2000, Chicago, IL, 60637, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liebovitz', 'Affiliation': 'Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, 750\u2009N. Lake Shore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Fornessa', 'Initials': 'F', 'LastName': 'Randal', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Jayaprakash', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Department of Internal Medicine, Section of General Internal Medicine, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Sang Mee', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Chicago Biological Sciences, 5841\u2009S. Maryland Ave, Rm W-254, MC2000, Chicago, IL, 60637, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lam', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA. hvallina@medicine.bsd.uchicago.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01045-4']
2147,33121544,Medically unexplained symptoms in children: an experimental investigation of the impact of internet searching on parental responses.,"BACKGROUND


Medically unexplained symptoms (MUS) are symptoms for which no medical cause can be identified. For children and adolescents, symptoms can be maintained through parental responses.
AIMS


The present study investigated the impact that internet searching of symptoms has on parental responses to MUS.
METHOD


One hundred and twenty-seven adult participants read a vignette in which they were asked to imagine they were a parent of a young person with MUS and completed visual analogue scales (VAS) reporting their beliefs, emotions and behavioural intentions about the MUS. Participants were then randomly assigned to one of three conditions: searching reputable websites for further information about the symptoms (n = 47), free search of any websites for further information about the symptoms (n = 38) or a control condition (n = 42) during which participants spent 10 minutes doing their usual behaviour on the internet, for example checking email and social media. Participants then completed the VAS for a second time.
RESULTS


Searching reputable websites led to a significantly greater decrease in behaviour VAS scores compared with the free search condition [F (1,123) = 11.374, p < .001], indicating that participants were less likely to seek a second opinion and to advise the child to avoid usual activities.
CONCLUSIONS


This study demonstrated that internet searching reputable sites for information regarding physical symptoms can be positive and it may therefore be advisable for health professionals meeting children with MUS to provide the family with information links to reputable sources.",2020,"RESULTS


Searching reputable websites led to a significantly greater decrease in behaviour VAS scores compared with the free search condition [F (1,123) = 11.374, p < .001], indicating that participants were less likely to seek a second opinion and to advise the child to avoid usual activities.
","['Medically unexplained symptoms in children', 'One hundred and twenty-seven adult participants read a vignette in which they were asked to imagine they were a parent of a young person with MUS and completed']","['searching reputable websites for further information about the symptoms (n = 47), free search of any websites for further information about the symptoms (n = 38) or a control condition (n = 42) during which participants spent 10 minutes doing their usual behaviour on the internet, for example checking email and social media']","['visual analogue scales (VAS) reporting their beliefs, emotions and behavioural intentions about the MUS', 'behaviour VAS scores']","[{'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",127.0,0.0622692,"RESULTS


Searching reputable websites led to a significantly greater decrease in behaviour VAS scores compared with the free search condition [F (1,123) = 11.374, p < .001], indicating that participants were less likely to seek a second opinion and to advise the child to avoid usual activities.
","[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Meredith', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Monteregge', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Bennett', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000752']
2148,33125510,"Effectiveness of vibrational forces on orthodontic treatment : A randomized, controlled clinical trial.","AIM


AcceleDent® Aura (OrthoAccel® Technologies, Bellaire, TX, USA) is a class II medical device with U.S. Food and Drug Administration approval that uses SoftPulse Technology™ to increase the speed of tooth movement. The aim of this study was to evaluate the application of vibrational forces on the rate of canine distalization.
METHODS


A total of 20 patients (10 boys and 10 girls) who had class II division 1 malocclusion or severe crowding and indicated first premolar extractions for treatment were included in the study. The patients were divided into two groups: 8 in the control group and 12 in the study group. Three-dimensional digital models were taken just before canine distalization and after space closure using the 3Shape TRIOS® R700 (3Shape Inc., Copenhagen, Denmark) device. Linear measurements between molars and canines were evaluated. The results were assessed with SPSS 23.0 program (IBM, Armonk, NY, USA).
RESULTS


One subject was excluded from the study group due to insufficient oral hygiene and poor patient compliance. Tooth movement rates were 1.06 mm/month for mandibular and maxillary canine teeth in the control group. In the study group, tooth movement rates were 1.24 mm/month for maxillary canines and 1.09 mm/month for mandibular canines. These differences were not statistically significant (p > 0.05).
CONCLUSION


AcceleDent® Aura is an easy-to-use device; however, in our study its application did not have any positive effects on canine retraction rates.",2020,"In the study group, tooth movement rates were 1.24 mm/month for maxillary canines and 1.09 mm/month for mandibular canines.","['orthodontic treatment ', '20\xa0patients (10\xa0boys and 10\xa0girls) who had class', 'II division 1 malocclusion or severe crowding and indicated first premolar extractions for treatment were included in the study']",[],"['SPSS 23.0 program (IBM, Armonk, NY, USA', 'speed of tooth movement', 'Tooth movement rates', 'tooth movement rates']","[{'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}]",,0.0421957,"In the study group, tooth movement rates were 1.24 mm/month for maxillary canines and 1.09 mm/month for mandibular canines.","[{'ForeName': 'Baris Can', 'Initials': 'BC', 'LastName': 'Telatar', 'Affiliation': 'Private Practice of Orthodontics, DMD, Piricelebi street, Rize, Turkey. bariscantelatar@gmail.com.'}, {'ForeName': 'Ahmet Yalcın', 'Initials': 'AY', 'LastName': 'Gungor', 'Affiliation': 'Private Practice of Orthodontics, PhD, Altınkum Street, Konyaaltı, Antalya, Turkey.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00257-z']
2149,33125516,"Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjects.","PURPOSE


To characterize the safety, pharmacodynamics, and pharmacokinetics (PK) of vericiguat in healthy males.
METHODS


Six phase I studies were conducted in European, Chinese, and Japanese males. Subjects received oral vericiguat as a single dose (0.5-15.0 mg solution [for first-in-human study] or 1.25-10.0 mg immediate release [IR tablets]) or multiple doses (1.25-10.0 mg IR tablets once daily [QD] or 5.0 mg IR tablets twice daily for 7 consecutive days). Bioavailability and food effects on vericiguat PK (IR tablets) were also studied in European subjects.
RESULTS


Overall, 255 of 265 randomized subjects completed their respective studies. There were no deaths or serious adverse events. Vericiguat was generally well tolerated at doses ≤ 10.0 mg. In the first-in-human study, the most frequent drug-related adverse events were headache and postural dizziness (experienced by five subjects each [7.2%]). Three of four subjects who received vericiguat 15.0 mg (oral solution, fasted) experienced orthostatic reactions. Vericiguat (≤ 10.0 mg, IR tablets) was rapidly absorbed (median time to reach maximum plasma concentration ≤ 2.5 h [fasted]) with a mean half-life of about 22.0 h (range 17.9-27.0 h for single and multiple doses). No evidence for deviation from dose proportionality or unexpected accumulation was observed. Administration of vericiguat 5.0 mg IR tablets with food increased bioavailability by 19% (estimated ratio 119% [90% confidence interval]: 108; 131]), reduced PK variability, and prolonged vericiguat absorption relative to the fasted state.
CONCLUSION


In general, vericiguat was well tolerated. These results supported further clinical evaluation of vericiguat QD in patients with heart failure.
REGISTRY NUMBERS


EudraCT: 2011-001627-21; EudraCT: 2012-000953-30.",2020,There were no deaths or serious adverse events.,"['I studies were conducted in European, Chinese, and Japanese males', 'European subjects', 'healthy subjects', 'patients with heart failure', 'healthy males', 'Six phase']","['oral vericiguat as a single dose (0.5-15.0\xa0mg solution [for first-in-human study] or 1.25-10.0\xa0mg immediate release [IR tablets]) or multiple doses (1.25-10.0\xa0mg IR tablets once daily [QD', 'Vericiguat (≤', 'vericiguat 15.0\xa0mg (oral solution']","['Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat', 'Bioavailability and food effects on vericiguat PK (IR tablets', 'orthostatic reactions', 'headache and postural dizziness', 'reduced PK variability, and prolonged vericiguat absorption relative', 'tolerated', 'bioavailability', 'deaths or serious adverse events', 'safety, pharmacodynamics, and pharmacokinetics (PK']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0234987', 'cui_str': 'Postural dizziness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",265.0,0.0413024,There were no deaths or serious adverse events.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boettcher', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Experimental Medicine, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PK CV, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Loewen', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Arens', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Clinical Sciences, Research & Development Japan, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Research & Development, Pharmaceuticals, Clinical PD CV, Bayer AG, Wuppertal, Germany. corina.becker@bayer.com.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03023-7']
2150,33125517,Protective effect of flumazenil infusion in severe acute benzodiazepine toxicity: a pilot randomized trial.,"OBJECTIVE


We aimed to investigate the efficacy of flumazenil infusion in the maintenance of arousal and prevention of development of complications in severe benzodiazepine poisoning.
MATERIALS AND METHOD


Sixty severely poisoned patients (intubated due to loss of consciousness) intoxicated by sole benzodiazepines referred to Loghman Hakim hospital between May 2018 and August 2019 were considered to be included in the current study. All were evaluated for possible contraindications of flumazenil administration. If there were no contraindications, we continued supportive care in one group and supportive care plus flumazenil infusion in the second group. Following response to the stat dose of flumazenil, complications, hospital stay, and outcome were compared between these two groups.
RESULTS


A total of 60 benzodiazepine-poisoned patients aged between 16 and 84 years old (37 males and 23 females) were enrolled. There was no statistically significant difference between these two groups regarding the period of hospital stay. Need for intubation significantly decreased in the infusion group. None of the patients experienced seizure or dysrhythmia. One patient died in the control group which received only a stat dose of flumazenil.
CONCLUSIONS


Administration of flumazenil is safe in benzodiazepine-poisoned patients with appropriate indications. Flumazenil infusion can significantly decrease the need for intubation and subsequent ICU admission. Even though flumazenil is an expensive antidote, its administration may decrease the need for ICU beds in the setting of acute poisoning.",2020,Need for intubation significantly decreased in the infusion group.,"['A total of 60 benzodiazepine-poisoned patients aged between 16 and 84 years old (37 males and 23 females', 'Sixty severely poisoned patients (intubated due to loss of consciousness) intoxicated by sole benzodiazepines referred to Loghman Hakim hospital between May 2018 and August 2019 were considered to be included in the current study', 'severe acute benzodiazepine toxicity']","['flumazenil infusion', 'Flumazenil', 'benzodiazepine', 'flumazenil']","['seizure or dysrhythmia', 'need for intubation and subsequent ICU admission', 'period of hospital stay']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.0601011,Need for intubation significantly decreased in the infusion group.,"[{'ForeName': 'Akram Sadat', 'Initials': 'AS', 'LastName': 'Razavizadeh', 'Affiliation': 'Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Ziaeefar', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hassanian@sbmu.ac.ir.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03031-7']
2151,33121714,Effects of Canagliflozin on Amino-Terminal Pro-B-Type Natriuretic Peptide: Implications for Cardiovascular Risk Reduction.,"BACKGROUND


Canagliflozin reduces cardiovascular events including hospitalization for heart failure (HHF) in patients with type 2 diabetes and cardiovascular risk. Elevated amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are associated with HF diagnosis and predict cardiovascular risk.
OBJECTIVES


The purpose of this study was to measure NT-proBNP in CANVAS (Canagliflozin Cardiovascular Assessment Study) participants.
METHODS


Associations between baseline NT-proBNP and cardiovascular, renal, and mortality outcomes and intervention-associated changes were determined.
RESULTS


Of the 4,330 participants in the CANVAS trial, NT-proBNP was measured in 3,587, 2,918, and 995 participants at baseline, 1 year, and 6 years, respectively. The median baseline NT-proBNP concentration was 91 pg/ml, and 39.3% had NT-proBNP ≥125 pg/ml. NT-proBNP was higher in those with investigator-reported HF (13% of participants at baseline) versus those without (187 pg/ml vs. 81 pg/ml), with substantial overlap between groups. By 1 year, NT-proBNP increased with placebo, whereas canagliflozin reduced NT-proBNP by 11% (geometric mean ratio for canagliflozin vs. placebo = 0.89 [95% confidence interval (CI): 0.84 to 0.94]; p < 0.001). Lower NT-proBNP with canagliflozin was also observed at 6 years (p = 0.004). In adjusted models, baseline NT-proBNP ≥125 pg/ml was prognostic for incident HHF (hazard ratio [HR]: 5.40; 95% CI: 2.67 to 10.9), HHF/cardiovascular death (HR: 3.52; 95% CI: 2.38 to 5.20), and all-cause death (HR: 2.53; 95% CI: 1.78 to 3.61). Mediation analyses suggested that 10.4% of the effects of canagliflozin on HHF were reflected in NT-proBNP lowering.
CONCLUSIONS


A substantial percentage of patients in the CANVAS trial had elevated NT-proBNP values. Canagliflozin reduced NT-proBNP concentrations versus placebo; however, reduction in NT-proBNP explained only a small proportion of the benefit of canagliflozin on HF events. (CANVAS [CANagliflozin cardioVascular Assessment Study]; NCT01032629).",2020,"By 1 year, NT-proBNP increased with placebo, whereas canagliflozin reduced NT-proBNP by 11% (geometric mean ratio for canagliflozin vs. placebo = 0.89 [95% confidence interval (CI): 0.84 to 0.94]; p < 0.001).","['NT-proBNP in CANVAS (Canagliflozin Cardiovascular Assessment Study) participants', 'patients with type 2 diabetes and cardiovascular risk', '4,330 participants in the CANVAS trial']","['placebo', 'Canagliflozin', 'canagliflozin']","['Elevated amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations', 'NT-proBNP', 'elevated NT-proBNP values', 'HHF/cardiovascular death', 'Canagliflozin reduced NT-proBNP concentrations', ' NT-proBNP', 'median baseline NT-proBNP concentration', 'baseline NT-proBNP and cardiovascular, renal, and mortality outcomes', 'canagliflozin reduced NT-proBNP']","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4330.0,0.492,"By 1 year, NT-proBNP increased with placebo, whereas canagliflozin reduced NT-proBNP by 11% (geometric mean ratio for canagliflozin vs. placebo = 0.89 [95% confidence interval (CI): 0.84 to 0.94]; p < 0.001).","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Massachusetts General Hospital and Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: jjanuzzi@partners.org.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Xinqiao Hospital, Army Military Medical University, Chongqing, China; Department of Cardiology, People's Liberation Army General Hospital, Beijing, China; The George Institute for Global Health, UNSW Sydney, Sydney, Australia.""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfeifer', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Missouri.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Glasgow Cardiovascular Research, Glasgow, United Kingdom.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Charles Perkins Centre, University of Sydney, Sydney, Australia; Imperial College London, London, United Kingdom.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hansen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.09.004']
2152,33121826,"Reply to Ethan B. Ludmir, Zachary R. McCaw, and Lee-Jen Wei's Letter to the Editor re: Karim Fizazi, Charles G. Drake, Tomasz M. Beer, et al. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.032. Interpreting the Effect of Ipilimumab following Radiotherapy for Patients with Postdocetaxel Metastatic Castration-resistant Prostate Cancer.",,2020,,['Patients with Postdocetaxel Metastatic Castration-resistant Prostate Cancer'],"['Ipilimumab Versus Placebo', 'Ipilimumab', 'Radiotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0621447,,"[{'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Wallingford, CT, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut de Cancérologie Gustave Roussy, University of Paris, Villejuif, France. Electronic address: karim.fizazi@igr.fr.'}]",European urology,['10.1016/j.eururo.2020.10.012']
2153,33121832,"Short-Term Topical Tetracaine Is Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: A Double-Blind, Randomized Clinical Trial.","STUDY OBJECTIVE


The objective of this study is to show that patients with corneal abrasions would experience more pain relief with short-term topical tetracaine than placebo.
METHODS


The study was a prospective, double-blind, randomized trial of tetracaine versus placebo set in the emergency department (ED). A total of 118 adults who presented with uncomplicated corneal abrasions were included and randomized. The intervention was either topical tetracaine or placebo applied every 30 minutes as needed for 24 hours. The primary outcome was the overall numeric rating scale pain score measured at the 24- to 48-hour ED follow-up examination.
RESULTS


One hundred eleven patients were included in the final analysis, 56 in the tetracaine group and 55 in the placebo group. At the 24- to 48-hour follow-up, the overall numeric rating scale pain score after use of the study drops was significantly lower in the tetracaine group (1) versus placebo group (8) (Δ7; 95% confidence interval 6 to 8). Patients in the tetracaine group used less hydrocodone than those in the placebo group. The complication rates between the 2 groups were similar.
CONCLUSION


Short-term topical tetracaine is an efficacious analgesic for acute corneal abrasions, is associated with less hydrocodone use compared with placebo, and was found to be safe in this sample.",2020,"CONCLUSION


Short-term topical tetracaine is an efficacious analgesic for acute corneal abrasions, is associated with less hydrocodone use compared with placebo, and was found to be safe in this sample.","['118 adults who presented with uncomplicated corneal abrasions', 'patients with corneal abrasions', 'One hundred eleven patients were included in the final analysis, 56 in the tetracaine group and 55 in the placebo group', 'Pain Caused by Corneal Abrasions']","['Tetracaine', 'tetracaine', 'topical tetracaine or placebo', 'placebo', 'hydrocodone']","['overall numeric rating scale pain score', 'complication rates', 'pain relief']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010032', 'cui_str': 'Corneal abrasion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",118.0,0.524173,"CONCLUSION


Short-term topical tetracaine is an efficacious analgesic for acute corneal abrasions, is associated with less hydrocodone use compared with placebo, and was found to be safe in this sample.","[{'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Shipman', 'Affiliation': 'Department of Emergency Medicine, INTEGRIS Southwest Medical Center, Oklahoma City, OK. Electronic address: stacia.shipman@integrisok.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Painter', 'Affiliation': 'Department of Emergency Medicine, INTEGRIS Southwest Medical Center, Oklahoma City, OK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Keuchel', 'Affiliation': 'Department of Emergency Medicine, INTEGRIS Southwest Medical Center, Oklahoma City, OK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bogie', 'Affiliation': 'Department of Emergency Medicine, INTEGRIS Southwest Medical Center, Oklahoma City, OK.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.08.036']
2154,33121861,A Prospective Randomized Trial of the Influence of Music on Anxiety in Patients Starting Radiation Therapy for Cancer.,"PURPOSE


One of the most downloaded articles in 2017 from the International Journal of Radiation Oncology, Biology, and Physics was a study suggesting that music therapy during radiation therapy (RT) simulation substantially reduces anxiety. To further evaluate the potential of music's clinical efficacy in the context of radiation therapy, we conducted a randomized trial evaluating the influence of genre-based music chosen by the study participant on anxiety during the first RT treatment session with a method that is applicable to routine clinical practice.
METHODS AND MATERIALS


We conducted a prospective randomized trial of music versus no music during the first RT treatment for cancer. We limited the study to women because prior studies document a higher rate of anxiety in female patients with cancer. Anxiety was evaluated before and after the first RT treatment using the State-Trait Anxiety Inventory (STAI) and Symptom Distress Thermometer (SDT). Patients randomized to music had their preferred genre of music played from a web-based application while in the treatment vault.
RESULTS


In the study, 102 females were enrolled (51 with and 51 without music). Baseline high anxiety score before RT was recorded in 48% of patients using the STAI and 58% using the SDT. The percent decrease in mean STAI score was 16% with music versus 10% without music (P = .2197). The mean SDT percent changes were a 13% decrease with music versus a 2% increase without music (P = .3298).
CONCLUSIONS


This study documents that high anxiety is common in women receiving RT for cancer and that music, as used in this study, does not reduce anxiety to a meaningful degree.",2020,The percent decrease in mean STAI score was 16% with music versus 10% without music (P = .2197).,"['female patients with cancer', 'Patients Starting Radiation Therapy for Cancer', 'cancer', '102 females were enrolled (51 with and 51 without music', 'women receiving RT for cancer and that music']","['music therapy during radiation therapy (RT) simulation', 'Music', 'radiation therapy']","['Baseline high anxiety score before RT', 'State-Trait Anxiety Inventory (STAI) and Symptom Distress Thermometer (SDT', 'Anxiety', 'anxiety', 'mean STAI score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",102.0,0.0541496,The percent decrease in mean STAI score was 16% with music versus 10% without music (P = .2197).,"[{'ForeName': 'Lillie', 'Initials': 'L', 'LastName': ""O'steen"", 'Affiliation': 'Department of Radiation Oncology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Lockney', 'Affiliation': 'Department of Radiation Oncology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Morris', 'Affiliation': 'Department of Radiation Oncology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Versie', 'Initials': 'V', 'LastName': 'Johnson-Mallard', 'Affiliation': 'University of Florida College of Nursing, Gainesville, Florida.'}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Pereira', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida College of Public Health and Health Professions, Gainesville, Florida.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Amdur', 'Affiliation': 'Department of Radiation Oncology, University of Florida College of Medicine, Gainesville, Florida. Electronic address: amdurr@shands.ufl.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.09.048']
2155,33121884,The effect of baricity of intrathecal bupivacaine for elective cesarean delivery on maternal cardiac output: a randomized study.,"BACKGROUND


Hemodynamic instability during spinal anesthesia for cesarean delivery is associated with adverse maternal and fetal outcomes. Plain and hyperbaric bupivacaine are commonly used for cesarean delivery, however, their distinctive pharmacologic properties may affect maternal hemodynamic profiles differently. The aim of this study was to compare hemodynamic profiles using a suprasternal Doppler cardiac output (CO) monitor in healthy term parturients randomized to receive plain or hyperbaric bupivacaine for cesarean delivery.
METHODS


One hundred sixty-eight healthy parturients scheduled for elective cesarean delivery were randomly assigned to receive 10.9 mg of intrathecal 0.5% plain or hyperbaric bupivacaine, both with 0.2 mg morphine. The primary outcome was CO change after spinal anesthesia. The Secondary outcomes were the incidence of hypotension, vasopressor use, and conversion to general anesthesia.
RESULTS


The mean (±SD) CO at baseline, 1 min and 5 min after spinal anesthesia, and after placental delivery was 4.6 ± 1.2, 5.4 ± 1.3, 5.1 ± 1.4, and 6.4 ± 1.7 L/min in the plain bupivacaine, and 4.5 ± 1.1, 5.2 ± 1.3, 4.9 ± 1.3, and 6.2 ± 1.9 L/min in the hyperbaric bupivacaine group. There were no significant differences in CO, mean arterial pressure, or systemic vascular resistance. Incidences of hypotension, vasopressor and supplemental analgesic use, and conversion to general anesthesia, were not different between groups.
CONCLUSIONS


Cardiac output changes after plain or hyperbaric bupivacaine were not different in term parturients undergoing spinal anesthesia for cesarean delivery. Further studies comparing block quality and the rate of conversion to general anesthesia are required.",2020,"Incidences of hypotension, vasopressor and supplemental analgesic use, and conversion to general anesthesia, were not different between groups.
","['parturients undergoing spinal anesthesia for cesarean delivery', 'One hundred sixty-eight healthy parturients scheduled for elective cesarean delivery', 'healthy term parturients']","['hyperbaric bupivacaine', 'suprasternal Doppler cardiac output (CO', 'plain or hyperbaric bupivacaine', 'intrathecal bupivacaine', 'intrathecal 0.5% plain or hyperbaric bupivacaine, both with 0.2\u202fmg morphine', 'Plain and hyperbaric bupivacaine', 'plain bupivacaine']","['incidence of hypotension, vasopressor use, and conversion to general anesthesia', 'Incidences of hypotension, vasopressor and supplemental analgesic use, and conversion to general anesthesia', 'CO, mean arterial pressure, or systemic vascular resistance', 'mean (±SD', 'maternal cardiac output', 'CO change after spinal anesthesia']","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0442195', 'cui_str': 'Suprasternal'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]",168.0,0.199765,"Incidences of hypotension, vasopressor and supplemental analgesic use, and conversion to general anesthesia, were not different between groups.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Limratana', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kiatchai', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Somnuke', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Prapakorn', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suksompong', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand. Electronic address: sirilak.suk@mahidol.ac.th.'}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2020.07.011']
2156,33121885,General anesthesia for cesarean delivery and childhood neurodevelopmental and perinatal outcomes: a secondary analysis of a randomized controlled trial.,"BACKGROUND


In 2016, the U.S. Food and Drug Administration expressed concern that neurodevelopment may be negatively affected by anesthesia or sedation exposure in pregnancy or before three years of age. We examined the association between general anesthesia at the time of cesarean delivery and early childhood neurodevelopment.
METHODS


A secondary analysis of a multicenter randomized controlled trial assessing magnesium for prevention of cerebral palsy in infants at risk for preterm delivery. Exposure was general compared to neuraxial anesthesia. The primary outcome was motor or mental delay at two years of age, assessed by Bayley Scales of Infant Development II (BSIDII). Secondary outcomes included BSIDII subdomains and perinatal outcomes. Multivariable logistic regression models were performed to control for confounders.
RESULTS


Of 557 women undergoing cesarean delivery, 119 (21%) received general anesthesia. There were no differences in the primary composite outcome of developmental delay (aOR 0.93, 95% CI 0.61 to 1.43) or the BSIDII subdomains of mild, moderate, or severe mental delay, or mild or moderate motor delay. Severe motor delay was more common among infants exposed to general anesthesia (aOR 1.98, 95% CI 1.06 to 3.69). Infants exposed to general anesthesia had longer neonatal intensive care stays (51 vs 37 days, P=0.010).
CONCLUSIONS


General anesthesia for cesarean delivery was not associated with overall neurodevelopmental delay at two years of age, except for greater odds of severe motor delay. Future studies should evaluate this finding, as well as the impact of longer or multiple anesthetic exposures across all gestational ages on neurodevelopment.",2020,"Infants exposed to general anesthesia had longer neonatal intensive care stays (51 vs 37 days, P=0.010).
","['infants at risk for preterm delivery', '557 women undergoing cesarean delivery, 119 (21%) received']","['magnesium', 'general anesthesia', 'General anesthesia']","['developmental delay', 'motor or mental delay at two years of age, assessed by Bayley Scales of Infant Development II (BSIDII', 'Severe motor delay', 'BSIDII subdomains and perinatal outcomes', 'overall neurodevelopmental delay', 'BSIDII subdomains of mild, moderate, or severe mental delay, or mild or moderate motor delay', 'neonatal intensive care stays']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520947', 'cui_str': 'Clumsiness - motor delay'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0021711', 'cui_str': 'Neonatal Intensive Care'}]",557.0,0.273212,"Infants exposed to general anesthesia had longer neonatal intensive care stays (51 vs 37 days, P=0.010).
","[{'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Robbins', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA. Electronic address: lsrobbins@uabmc.edu.""}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Blanchard', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA.""}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Biasini', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, USA.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Powell', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA; Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, USA.""}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA.""}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA.""}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham, USA; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA.""}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2020.08.007']
2157,33121997,Oxaliplatin-Based Adjuvant Chemotherapy Duration (3 vs. 6 Months) for High-Risk Stage II Colon Cancer: The Randomized Phase 3 ACHIEVE-2 Trial.,"BACKGROUND


Oxaliplatin-based adjuvantchemotherapy may be associated with debilitating peripheral sensory neuropathy (PSN) in patients with high-risk colon cancer. This open-label, multicenter, randomized phase 3 trial was as a prospective pooled analysis conducted to investigate the non-inferiority of 3 versus 6 months of adjuvant oxaliplatin-based chemotherapy in stage II disease.
PATIENTS AND METHODS


From February 12, 2014 to January 31, 2017, 525 Asian patients with high-risk stage II colon cancer were randomly assigned to 3- and 6-month treatment arms. The treatment consisted of either modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine combined with oxaliplatin (CAPOX). The primary endpoint was disease-free survival (DFS). The secondary endpoints were treatment compliance and safety.
RESULTS


Of the 525 randomized patients, 11 were not treated. Among the 514 participating patients (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received CAPOX, and 184 (36%) presented T4 as a high-risk factor for recurrence. The 3-year DFS rate was 88.2% in the 3-month arm and 87.9% in the 6-month arm (hazard ratio [HR], 1.12; 95% CI, 0.67-1.87). With CAPOX, the 3-year DFS rate was 88.2% in the 3-month arm and 88.4% in the 6-month arm (HR, 1.13; 95% CI, 0.65-1.96). The discontinuation rate in the 3- and 6-month arms was 10% and 31% for mFOLFOX6 (P = 0.0193), and 15% and 35% for CAPOX (P < 0.0001), respectively. The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
CONCLUSIONS


Three months of combination therapy presented significantly less grade ≥2 PSN than the respective 6-month regimen. The shortened therapy duration did not affect the 3-year DFS rate, suggesting that a 3-month course of CAPOX can be an effective treatment option.",2020,"The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
","['patients with high-risk colon cancer', '514 participating patients (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received', 'High-Risk Stage II Colon Cancer', 'stage II disease', 'From February 12, 2014 to January 31, 2017, 525 Asian patients with high-risk stage II colon cancer']","['modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine combined with oxaliplatin (CAPOX', 'CAPOX', 'Oxaliplatin-Based Adjuvant Chemotherapy Duration', 'adjuvant oxaliplatin-based chemotherapy', 'Oxaliplatin-based adjuvantchemotherapy']","['disease-free survival (DFS', '3-year DFS rate', 'discontinuation rate', 'grade ≥2 PSN', 'treatment compliance and safety', 'incidence of grade ≥2 PSN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",525.0,0.106532,"The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Gastrointestinal Center, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Department of Gastrointestinal Cancer Center, Sano Hospital, Hyogo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gamoh', 'Affiliation': 'Department of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Division of Colon and Rectal Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rikiyama', 'Affiliation': 'Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ueki', 'Affiliation': 'Department of Surgery, Hamanouchi Hospital, Fukuoka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shinkai', 'Affiliation': 'Department of Surgery, Chigasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tanida', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kochi Hospital, Kochi, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of tumor Surgery, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. Electronic address: tyoshino@east.ncc.go.jp.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.480']
2158,33122028,Mind/Body (Hypnotherapy) Treatment of Women with Urgency Urinary Incontinence: Changes in Brain Attentional Networks.,"BACKGROUND


Prior study of patients with urgency urinary incontinence by functional magnetic resonance imaging showed altered function in areas of the brain associated with interoception and salience and with attention. Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at two months. A sub-sample of these urgency urinary incontinent women underwent functional magnetic resonance imaging before and after treatment.
OBJECTIVE


To determine if hypnotherapy treatment of urgency urinary incontinence compared to pharmacotherapy was associated with altered brain activation or resting connectivity on functional Magnetic Resonance Imaging.
STUDY DESIGN


A sub-sample of women participating in a randomized control trial comparing hypnotherapy versus pharmacotherapy for treatment of urgency urinary incontinence was evaluated with functional magnetic resonance imaging. Scans were obtained pretreatment and 8-12 weeks after treatment initiation. Brain activation during bladder-filling and resting functional connectivity with an empty and partially filled bladder were assessed. Brain regions of interest were derived from those previously showing differences between healthy controls and untreated urgency urinary incontinence participants in our prior work, and included regions in the interoceptive and salience, ventral attentional and dorsal attentional networks.
RESULTS


Following treatment, participants in both groups demonstrated marked improvement in incontinence episodes (p < .001). Bladder filling task functional magnetic resonance imaging data from the combined groups (n=64, 30 Hypnotherapy, 34 Pharmacotherapy) demonstrated decreased activation of the left temporoparietal junction, a component of the ventral attentional network (p<.01) compared to baseline. Resting functional connectivity differed only with the bladder partially filled (n = 54). Compared to pharmacotherapy, hypnotherapy participants manifested increased functional connectivity between the anterior cingulate cortex and the left dorsolateral prefrontal cortex, a component of the dorsal attentional network (p<.001).
CONCLUSIONS


Successful treatment of urgency urinary incontinence with both pharmacotherapy and hypnotherapy was associated with decreased activation of the ventral (bottom up) attentional network during bladder filling. This may be attributable to decreased afferent stimuli arising from the bladder in the pharmacotherapy group. In contrast, decreased ventral attentional network activation associated with hypnotherapy may be mediated by the counterbalancing effects of the dorsal (top down) attentional network.",2020,Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at two months.,"['urgency urinary incontinent women underwent', 'Women with Urgency Urinary Incontinence', 'healthy controls and untreated urgency urinary incontinence participants', 'patients with urgency urinary incontinence', 'A sub-sample of women participating', 'urgency urinary incontinence']","['hypnotherapy', 'Mind/Body (Hypnotherapy', 'hypnotherapy versus pharmacotherapy', 'functional magnetic resonance imaging']","['incontinence episodes', 'functional connectivity', 'Resting functional connectivity', 'urgency urinary incontinence symptoms', 'activation of the left temporoparietal junction, a component of the ventral attentional network', 'urgency urinary incontinence', 'activation of the ventral (bottom up) attentional network', 'ventral attentional network activation']","[{'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0231238', 'cui_str': 'Incontinent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0528771,Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at two months.,"[{'ForeName': 'Loren H', 'Initials': 'LH', 'LastName': 'Ketai', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, New Mexico. Electronic address: lketai@salud.unm.edu.'}, {'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, New Mexico.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Schrader', 'Affiliation': 'University of New Mexico Clinical and Translational Science Center, Albuquerque, New Mexico.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, New Mexico; University of Texas Dell Medical School, Austin, Texas.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, New Mexico.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dodd', 'Affiliation': 'Mind Research Network, Albuquerque, New Mexico.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, Albuquerque, New Mexico.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.10.041']
2159,33122054,MINIMALLY INVASIVE DISMEMBERED EXTRAVESICAL CROSS-TRIGONAL URETERAL REIMPLANTATION FOR OBSTRUCTED MEGAURETER: A MULTI-INSTITUTIONAL STUDY COMPARING ROBOTIC AND LAPAROSCOPIC APPROACHES.,"OBJECTIVES


To compare two minimally invasive surgical options for the treatment of obstructed megaureter: robot assisted dismembered extravesical cross-trigonal ureteral reimplantation (RADECUR) and laparoscopic dismembered extravesical cross-trigonal ureteral reimplantation (LDECUR).
METHODS


A two arm retrospective comparative study, including all pediatric patients who underwent ureteral reimplantation of unilateral obstructed megaureter, either by RADECUR or LDECUR. Patient demographics, perioperative surgical data, complications, and results are described. The surgical technique in both arms was similar: dismembering of the ureter, performing an extravesical cross-trigonal detrusorotomy, and intracorporeal tailoring of the ureter when indicated, were the pivotal maneuvers utilized.
RESULTS


The study included 95 patients (48 and 47 in the RADECUR and LDECUR arms, respectively) operated between the years 2016-2019. Overall, median age at surgery was 24 months (IQR 12-48) and median weight was 14 kg (IQR 11-21). Median operative time was 93 minutes (IQR 90-120) for RADECUR and 130 minutes (IQR 105-160) for LDECUR (p < 0.001). Intracorporeal excisional tapering was performed in 11 of the RADECUR patients and 19 LDECUR patients. Grade 1-2 Clavien-Dindo complications occurred in seven patients, and grade 3 complication in one patient in the RADECUR arm. In the LDECUR arm, grade 1-2 complications occurred in two patients, and two had a grade 3 complications. Surgical success was achieved in 97% and 94% in the RADECUR and LDECUR groups, respectively.
CONCLUSIONS


Unilateral robotic extravesical cross-trigonal ureteral re-implantation for treatment of obstructed megaureter in the pediatric population is safe and effective both for RADECUR and LDECUR. Operative time is significantly shorter for RADECUR.",2020,"To compare two minimally invasive surgical options for the treatment of obstructed megaureter: robot assisted dismembered extravesical cross-trigonal ureteral reimplantation (RADECUR) and laparoscopic dismembered extravesical cross-trigonal ureteral reimplantation (LDECUR).
","['CROSS-TRIGONAL URETERAL REIMPLANTATION FOR OBSTRUCTED MEGAURETER', 'all pediatric patients who underwent ureteral reimplantation of unilateral obstructed megaureter, either by RADECUR or LDECUR', '95 patients (48 and 47 in the RADECUR and LDECUR arms, respectively) operated between the years 2016-2019']","['extravesical cross-trigonal ureteral reimplantation (RADECUR) and laparoscopic dismembered extravesical cross-trigonal ureteral reimplantation (LDECUR', 'Unilateral robotic extravesical cross-trigonal ureteral re-implantation', 'Intracorporeal excisional tapering']","['grade 1-2 complications', 'Grade 1-2 Clavien-Dindo complications', 'median weight', 'Operative time', 'Surgical success', 'Median operative time']","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0521620', 'cui_str': 'Dilatation of ureter'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0442096', 'cui_str': 'Extravesical approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442096', 'cui_str': 'Extravesical approach'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",95.0,0.0623942,"To compare two minimally invasive surgical options for the treatment of obstructed megaureter: robot assisted dismembered extravesical cross-trigonal ureteral reimplantation (RADECUR) and laparoscopic dismembered extravesical cross-trigonal ureteral reimplantation (LDECUR).
","[{'ForeName': 'Yishai H', 'Initials': 'YH', 'LastName': 'Rappaport', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: rappaport.urology@gmail.com.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kord', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Noh', 'Affiliation': 'University Urology, 3290 Dauphin Street, Mobile, AL, USA.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Koucherov', 'Affiliation': 'Departments of Urology & Pediatric Urology, Shaare Zedek Medical Center; Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Jaudat', 'Initials': 'J', 'LastName': 'Gaber', 'Affiliation': 'Departments of Urology & Pediatric Urology, Shaare Zedek Medical Center; Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shumaker', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Zisman', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Stav', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Chertin', 'Affiliation': 'Departments of Urology & Pediatric Urology, Shaare Zedek Medical Center; Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Dubrov', 'Affiliation': ""Department of Pediatric Urology, Children's City Clinical Hospital, Minsk, Republic of Belarus.""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Bondarenko', 'Affiliation': 'Department of Pediatric Urology, Municipal Hospital, Volgograd, Russia.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Neheman', 'Affiliation': 'Department of Urology, Shamir Medical Center, Zerifin, Israel; Affiliated to the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}]",Urology,['10.1016/j.urology.2020.10.018']
2160,33122092,Effects of two nights of sleep deprivation on executive function and central and peripheral fatigue during maximal voluntary contraction lasting 60 s.,"PURPOSEː: The current study aimed at assessing the effect of a trial of two nights of sleep deprivation (SDT) on mood, sleepiness, motivation and cognitive and motor performance. METHODSː: Thirty-six healthy young and physically active adult men (17 in the control group and 19 in the SDT group) completed a 48-h control or 48-h SDT. For the SDT, participants did not sleep for 48 h. Executive function (attention and inhibitory control) in the Go/No-Go and Stroop tests, mood, sleepiness, motivation, heart rate variability (HRV), motor performance in a hand grip strength test, and 60-s maximal isometric contraction (MVC-60 s) of knee extension were evaluated at 9-11 am on consecutive days 1, 2, and 3. RESULTS: One night of sleep deprivation increased sleepiness, decreased mood, motivation and motor endurance but did not affect executive function (as measured in the Stroop and Go/No-Go tests), the MVC for hand and leg knee extensor muscles, and peripheral motor fatigue in the leg MVC-60 s task. However, the central activation ratio (CAR) decreased significantly during the MVC-60 s. The SDT significantly contributed to the decrease in these functions. That is, the SDT reduced executive function (increased reaction time during Go/No-Go test), MVC of knee extension, and the CAR before and after the MVC-60 s. By contrast, the SDT did not increase CAR immediately after the MVC-60 s and did not decrease the rate of torque development (RTD). CONCLUSIONSː: The SDT significantly impaired mood, motivation and increased sleepiness and HRV, reduced MVC of knee extensor muscles (but not RTD) and motor performance during the MVC-60 s and worsened executive function (attention and inhibitory control) only during the Go/No-Go task. However, the SDT did not reduce hand grip strength and CAR immediately after the MVC-60 s of knee extensor muscles.",2020,"The SDT significantly impaired mood, motivation and increased sleepiness and HRV, reduced MVC of knee extensor muscles (but not RTD) and motor performance during the MVC-60 s and worsened executive function (attention and inhibitory control) only during the Go/No-Go task.",['Thirty-six healthy young and physically active adult men (17 in the control group and 19 in the SDT group) completed a'],"['maximal voluntary contraction lasting 60 s', 'sleep deprivation', 'SDT', 'sleep deprivation (SDT', '48-h control or 48-h SDT']","['executive function (increased reaction time', 'MVC for hand and leg knee extensor muscles, and peripheral motor fatigue', 'mood, motivation and motor endurance', 'mood, motivation and increased sleepiness and HRV, reduced MVC of knee extensor muscles (but not RTD) and motor performance during the MVC-60 s and worsened executive function (attention and inhibitory control', 'mood, sleepiness, motivation and cognitive and motor performance', 'executive function and central and peripheral fatigue', 'Go and Stroop tests, mood, sleepiness, motivation, heart rate variability (HRV), motor performance in a hand grip strength test, and 60-s maximal isometric contraction (MVC-60 s) of knee extension', 'central activation ratio (CAR', 'executive function', 'rate of torque development (RTD', 'hand grip strength and CAR']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",36.0,0.0279494,"The SDT significantly impaired mood, motivation and increased sleepiness and HRV, reduced MVC of knee extensor muscles (but not RTD) and motor performance during the MVC-60 s and worsened executive function (attention and inhibitory control) only during the Go/No-Go task.","[{'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Faculty of Medicine, Vilnius University, M. K. Čiurlionio str. 21/27, LT-03101, Vilnius, Lithuania; Education Academy, Vytautas Magnus University, Jonavos str. 66 - 310, 44191 Kaunas, Lithuania.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kazlauskaite', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zlibinaite', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Agne', 'Initials': 'A', 'LastName': 'Cekanauskaite', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Dovile', 'Initials': 'D', 'LastName': 'Valanciene', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania. Electronic address: dovile.valanciene@lsu.lt.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Karanauskiene', 'Affiliation': 'Department of Health, Physical and Social Education, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Ilona Judita', 'Initials': 'IJ', 'LastName': 'Zuoziene', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Majauskiene', 'Affiliation': 'Department of Health, Physical and Social Education, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickeviciene', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Satas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, Sporto str. 6, 44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113226']
2161,33122456,An  in vivo  electromyographic evaluation of pain relief using different therapies in masticatory myalgia patients.,"Objectives


: This study is aimed to evaluate and compare the effect of moist heat fomentation therapy with ultrasound therapy in patients with the masticatory myalgia.
Materials and Methods


The study was conducted on 42 patients with masticatory myalgia, dividing them into two groups; Group A (21 patients), received moist heat therapy and Group B (21 patients), received ultrasound therapy for seven effective days. Prior and after the treatment the numeric rating scale (NRS) and the electromyography (EMG) scores were recorded and compared. The observations were analyzed clinically and statistical support was taken to assess the NRS and EMG data.
Results


Irrespective of the groups, patients testified a significant reduction in pain after the treatment. From the EMG readings; even though the standard deviation for each group was varied considerably, EMG recorded an improved muscle activity. Statistical analysis was used to assess and identify the best treatment methodology between the two modalities.
Conclusion


From the statistical analysis, it is concluded that, though both the therapies had significantly reduced the symptomatic response, it is moist heat fomentation that improved muscle activity both statistically and clinically in comparison to ultrasound.",2020,"Irrespective of the groups, patients testified a significant reduction in pain after the treatment.","['patients with the masticatory myalgia', 'masticatory myalgia patients', '42 patients with masticatory myalgia, dividing them into two groups; Group A (21 patients), received']","['ultrasound therapy', 'moist heat fomentation therapy with ultrasound therapy', 'moist heat therapy']","['symptomatic response', 'numeric rating scale (NRS) and the electromyography (EMG) scores', 'muscle activity', 'pain relief', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",42.0,0.0179093,"Irrespective of the groups, patients testified a significant reduction in pain after the treatment.","[{'ForeName': 'Parvathi K', 'Initials': 'PK', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Prosthodontics, Nitte (Deemed to be University), AB Shetty Memorial Institute of Dental Sciences (ABSMIDS), Mangalore, India.'}, {'ForeName': 'Sowmya M', 'Initials': 'SM', 'LastName': 'Kumar', 'Affiliation': 'Department of Prosthodontics, Nitte (Deemed to be University), AB Shetty Memorial Institute of Dental Sciences (ABSMIDS), Mangalore, India.'}, {'ForeName': 'Purushotham', 'Initials': 'P', 'LastName': 'Chippala', 'Affiliation': 'Nitte Institute of Physiotherapy (NIPT), Nitte (Deemed to be University), Mangalore, India.'}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Hegde', 'Affiliation': 'Department of Prosthodontics, Nitte (Deemed to be University), AB Shetty Memorial Institute of Dental Sciences (ABSMIDS), Mangalore, India.'}]",Journal of the Korean Association of Oral and Maxillofacial Surgeons,['10.5125/jkaoms.2020.46.5.321']
2162,33122529,"Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone in the Treatment of Hypertriglyceridemic Pancreatitis (LIHTGP Trial): Study Protocol for a Multicenter, Prospective, Single-Blind, Randomized Controlled Trial.","OBJECTIVE


Currently, insulin and/or heparin/low-molecular-weight heparin (LMWH) serve as an early lipid-lowering treatment for hypertriglyceridemic pancreatitis (HTGP). However, whether the clinical prognosis of combining LMWH with insulin is superior to using insulin alone remains unknown. This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
METHODS


In total, 476 eligible participants will be recruited from 18 hospitals throughout China. Participants in the LMWH group will receive LMWH combined with insulin, whereas insulin alone will be administered to those in the insulin group. The patients will be followed up at 3 and 6 months after discharge. Adverse reactions will be evaluated by the safety monitoring committee. Safety outcomes and adverse events will also be recorded.
RESULTS


The study is registered in the Chinese Clinical Trial Registry (No: ChiCTR1900023640). Recruitment will begin in August 2019 and will be completed in December 2021 (http://www.chictr.org.cn/index.aspx). No data are available now.
CONCLUSIONS


The trial will investigate the efficacy of using LMWH combined with insulin as an emergency lipid-lowering treatment in reducing new organ failure, mortality, hospital stays, and expenses compared using with insulin alone for patients with HTGP.",2020,"This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
","['476 eligible participants will be recruited from 18 hospitals throughout China', 'HTGP patients', 'Hypertriglyceridemic Pancreatitis (LIHTGP Trial', 'patients with HTGP', 'hypertriglyceridemic pancreatitis (HTGP']","['insulin and/or heparin/low-molecular-weight heparin (LMWH', 'LMWH combined with insulin, whereas insulin alone', 'insulin alone', 'LMWH combined with insulin', 'Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone', 'LMWH with insulin and an insulin regimen', 'LMWH']","['new organ failure, mortality, hospital stays, and expenses', 'Safety outcomes and adverse events', 'Adverse reactions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",476.0,0.192249,"This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
","[{'ForeName': 'Bingjun', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'From the Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Nianshuang', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'JiaRong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Youxiang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Nonghua', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': ''}]",Pancreas,['10.1097/MPA.0000000000001697']
2163,33122540,Sit Less and Move More - A Multi-Component Intervention With and Without Height-Adjustable Workstations in Contact Centre Call Agents: A Pilot Randomised Controlled Trial.,"OBJECTIVE


To pilot a multi-component intervention to sit less and move more, with (SLAMM+) and without (SLAMM) height-adjustable workstations, in contact centre call agents.
METHODS


Agents were individually randomised to SLAMM or SLAMM+ in this 10-month, parallel, open-label, pilot trial. Mixed-methods assessed response, recruitment, retention, attrition and completion rates, adverse effects, trial feasibility and acceptability, preliminary effectiveness on worktime sitting, and described secondary outcomes.
RESULTS


The participant recruitment rate, and randomisation, data collection and interventions were mostly acceptable. Refinements to organisation recruitment were identified. High staff turnover negatively impacted retention and completion rates. The multi-component intervention with height-adjustable workstations has potential to reduce sitting time at work.
CONCLUSIONS


The demonstrated findings will help prepare for a future randomised controlled trial designed to assess the effect of the interventions.",2020,High staff turnover negatively impacted retention and completion rates.,[],"['SLAMM or SLAMM', 'Sit Less and Move More - A Multi-Component Intervention']","['response, recruitment, retention, attrition and completion rates, adverse effects, trial feasibility and acceptability, preliminary effectiveness on worktime sitting, and described secondary outcomes']",[],"[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.159227,High staff turnover negatively impacted retention and completion rates.,"[{'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Morris', 'Affiliation': 'Department of Health Research, Lancaster University, Bailrigg Campus, LA1 4YW (Morris), Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, 5 Primrose Hill, Liverpool, L3 2EX, UK (Morris, Murphy, Hopkins, Low, Shepherd, Gavin, Graves), School of Public Health, The University of Queensland, Brisbane, Australia (Healy), Baker Heart & Diabetes Institute, Melbourne, Victoria, Australia (Healy), School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia (Healy), Diabetes Research Centre, University of Leicester, Leicester, UK (Edwardson), NIHR Leicester Biomedical Research Centre, Leicester, LE5 4PW, UK (Edwardson), Department of Public Health and Policy, University of Liverpool, Waterhouse Building, Block B, 2nd Floor Liverpool, L69 3BX, UK (Collins), Public Health Institute, Faculty of Health, Education and Community, Liverpool John Moores University, 3rd Floor, Exchange Station, Tithebarn Street, Liverpool, L2 2QP, UK (Timpson), and Health Economics Bristol, Population Health Sciences, University of Bristol, BS8 1NU (Cochrane).'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Hopkins', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Low', 'Affiliation': ''}, {'ForeName': 'Genevieve N', 'Initials': 'GN', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': ''}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Timpson', 'Affiliation': ''}, {'ForeName': 'Sam O', 'Initials': 'SO', 'LastName': 'Shepherd', 'Affiliation': ''}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cochrane', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gavin', 'Affiliation': ''}, {'ForeName': 'Lee E F', 'Initials': 'LEF', 'LastName': 'Graves', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002066']
2164,33122547,Dissemination of a Universally Delivered Brief Alcohol Intervention in United States Air Force Technical Training.,"OBJECTIVES


Heavy alcohol use is a particular problem in the US military, prompting the Institute of Medicine to identify it as a public health crisis. Developing prevention programs aimed at reducing problematic drinking during military service would be useful. Thus, the purpose of the current study, was to broadly disseminate and assess the effectiveness of a brief alcohol intervention (BAI) + random breathalyzer (RB) intervention to reduce alcohol related incidents (ARIs), to all incoming Air Force trainees.
METHODS


The BAI was administered to all incoming Airmen (N = 15,898) across 4 major training Air Force bases. Additionally, underage Airmen were subject to RB tests. A quasi-experimental pre-test post-test design compared the rate of ARIs, per 100,000 training days, during the year prior and the year after the intervention was delivered.
RESULTS


A Poisson model indicated that the BAI + RB intervention was associated with a decrease in ARIs across all bases. Overall, the intervention lowered the ARI rate by 16% (β = -0.178, standard error  = 0.0742, P = 0.016). For every 100,000 training days, annual ARIs decreased from 30.8 to 25.5 after implementation.
CONCLUSIONS


A universally administered brief alcohol intervention, coupled with RB targeting underage drinkers, was associated with a reduction in the rate of ARIs. Results of this large-scale prevention study indicate that a brief alcohol intervention can be widely disseminated during US Air Force training and can perhaps reduce costs and make a public health contribution by decreasing alcohol related incidents.",2020,"Overall, the intervention lowered the ARI rate by 16% (β = -0.178, standard error  = 0.0742, P = 0.016).",[],"['alcohol intervention (BAI) + random breathalyzer (RB) intervention', 'alcohol intervention']","['ARIs', 'ARI rate', 'annual ARIs']",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0179415', 'cui_str': 'Breath analyzer'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",,0.0150709,"Overall, the intervention lowered the ARI rate by 16% (β = -0.178, standard error  = 0.0742, P = 0.016).","[{'ForeName': 'Gerald Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA (GWT, TM, XQW, MAL, RCK); Division of Primary Care Internal Medicine, Mayo Clinic, Rochester, MN (JE); Department of Psychology, University of Memphis, Memphis, TN (MCF, JGM, MM).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McMurry', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ebbert', 'Affiliation': ''}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': ''}, {'ForeName': 'Xin Qun', 'Initials': 'XQ', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'McDevitt-Murphy', 'Affiliation': ''}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000763']
2165,33122571,"Dexmedetomidine for prevention of postoperative delirium in older adults undergoing oesophagectomy with total intravenous anaesthesia: A double-blind, randomised clinical trial.","BACKGROUND


Dexmedetomidine is known to be a sedative. Recent studies suggest that administration of dexmedetomidine can prevent postoperative delirium (POD) which has been confirmed as a common complication after major surgery. However, its effects in patients undergoing oesophagectomy are scarce.
OBJECTIVE


To investigate the efficacy and safety of dexmedetomidine in reducing POD in elderly patients after transthoracic oesophagectomy with total intravenous anaesthesia (TIVA).
DESIGN


A randomised, double-blind, placebo-controlled trial.
SETTING


Single-centre, tertiary care hospital, November 2016 to September 2018.
PATIENTS


Eligible patients (n = 177) undergoing transthoracic oesophagectomy were randomly assigned to receive total intravenous anaesthesia (TIVA, n = 87) or dexmedetomidine with TIVA (DEX-TIVA, n = 90).
INTERVENTIONS


Patients receiving DEX-TIVA received a loading dose of dexmedetomidine (0.4 μg kg), over 15 min, followed by a continuous infusion at a rate of 0.1 μg kg h until 1 h before the end of surgery. Patients receiving TIVA received physiological saline with a similar infusion rate protocol.
OUTCOME MEASURES


The primary outcome was the incidence of POD. The secondary endpoints were the incidence of emergence agitation, serum interleukin-6 (IL-6) levels and haemodynamic profile.
RESULTS


All randomised patients were included with planned intention-to-treat analyses for POD. Delirium occurred in 15 (16.7%) of 90 cases given dexmedetomidine, and in 32 (36.8%) of 87 cases given saline (P = 0.0036). The DEX-TIVA group showed less frequent emergence agitation than the TIVA group (22.1 vs. 48.0%, P = 0.0058). The incremental change in surgery-induced IL-6 levels was greater in the TIVA group than DEX-TIVA group (P < 0.0001).
CONCLUSION


Adding peri-operative dexmedetomidine to a total intravenous anaesthetic safely reduces POD and emergence agitation in elderly patients undergoing open transthoracic oesophagectomy. These benefits were associated with a postoperative reduction in circulating levels of the pro-inflammatory cytokine IL-6 and stabilisation of the haemodynamic profile.
TRIAL REGISTRATION


Chinese Clinical Trial Registry Identifier: ChiCTR-IPR-17010881.",2020,"These benefits were associated with a postoperative reduction in circulating levels of the pro-inflammatory cytokine IL-6 and stabilisation of the haemodynamic profile.
","['Single-centre, tertiary care hospital, November 2016 to September 2018', 'elderly patients undergoing open transthoracic oesophagectomy', 'older adults undergoing oesophagectomy with total intravenous anaesthesia', 'elderly patients after transthoracic oesophagectomy with total intravenous anaesthesia (TIVA', 'Eligible patients (n\u200a=\u200a177) undergoing', 'patients undergoing oesophagectomy are scarce']","['DEX-TIVA received a loading dose of dexmedetomidine', 'DEX-TIVA', 'Dexmedetomidine', 'transthoracic oesophagectomy', 'placebo', 'total intravenous anaesthesia (TIVA, n\u200a=\u200a87) or dexmedetomidine with TIVA (DEX-TIVA, n\u200a=\u200a90', 'physiological saline', 'dexmedetomidine']","['incidence of emergence agitation, serum interleukin-6 (IL-6) levels and haemodynamic profile', 'Delirium', 'efficacy and safety', 'incidence of POD', 'frequent emergence agitation', 'postoperative delirium (POD', 'incremental change in surgery-induced IL-6 levels', 'POD and emergence agitation']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",177.0,0.72448,"These benefits were associated with a postoperative reduction in circulating levels of the pro-inflammatory cytokine IL-6 and stabilisation of the haemodynamic profile.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""From the Department of Anaesthesiology, The Second Hospital of Anhui Medical University, and Key Laboratory of Anaesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei (JH, YZ), Department of Anaesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, China (MZ, ZG, SZ, JC), Department of Anaesthesiology, University of Utah, Salt Lake City, Utah (XF) and Department of Anaesthesia and Perioperative Care and Centre for Cerebrovascular Research, University of California, San Francisco, San Francisco, California, USA (XF, MM).""}, {'ForeName': 'Mudan', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Zongbin', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mervyn', 'Initials': 'M', 'LastName': 'Maze', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001382']
2166,33126095,Can counter-advertising protect spectators of elite sport against the influence of unhealthy food and beverage sponsorship? A naturalistic trial.,"RATIONALE AND OBJECTIVE


Unhealthy, energy-dense nutrient-poor foods and beverages are heavily promoted through sport sponsorship. This naturalistic trial assessed whether exposing young adult spectators to various types of counter-advertising (CA) before watching an unhealthy food sponsored elite sporting event could diminish sponsorship effects and increase support for restrictions on sponsorship.
METHOD


Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement); (B) anti-industry CA (critiquing unhealthy food industry sponsorship of sport); (C) anti-product CA (critiquing the association of sports stars with unhealthy food); or (D) negative health effects CA (highlighting negative health consequences of unhealthy food consumption). Participants (N = 1316) completed a pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship.
RESULTS


Participants who reported watching the AFL Grand Final (n = 802) answered post-test measures within five days of the event. Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA. The anti-industry CA promoted less favourable attitudes to sponsor brands, the anti-product CA promoted reduced intentions to purchase the fast-food sponsor brand, and the negative health effects CA reduced preferences for fast food in general compared to the control condition.
CONCLUSIONS


Anti-industry CA may detract from favourable attitudes to unhealthy food sponsor brands and negative health effects CA may detract from intentions to consume fast food in the face of unhealthy food sponsorship exposure. Such interventions may require higher dosage levels than applied in the present study to bolster spectators' resistance to the surfeit of unhealthy food sport sponsorship.",2020,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","['Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement', 'Participants (N\xa0=\xa01316) completed a']","['pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship', 'counter-advertising (CA']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],,0.017522,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia; School of Psychology, Curtin University, Bentley, Western Australia, Australia. Electronic address: Helen.Dixon@cancervic.org.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'Early Start, School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'The George Institute for Global Health, Newtown, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'School of Life and Environment Sciences, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Heart Foundation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113415']
2167,33126096,Reducing HIV- and TB-Stigma among healthcare co-workers in South Africa: Results of a cluster randomised trial.,"RATIONALE


The HIV and TB co-epidemic has a severe impact on the South African healthcare workforce and health system. HIV- and TB- stigma directed from healthcare workers (HCWs) towards colleagues not only has a negative impact on the mental health and well-being of the HCWs, but has been identified as a barrier to their own health-seeking behaviour. It also increases the strain on the health system due to absenteeism.
OBJECTIVE


This cluster-randomised trial tested an intervention to reduce HIV- and TB-stigma among HCWs. The intervention, based on the theory of Diffusion of Innovations consisted of training healthcare workers as change agents in a Social and Behavioural Change Communication workshop to help them change stigmatising attitudes in the workplace. This was supported by a social marketing campaign.
METHODS


Eight hospitals in the Free State province were randomised into intervention and control group in a stratified study design. 652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018. Since the study only used four hospitals per intervention arm, cluster-based summaries were compared when analysing the intervention effect, using the nonparametric Mann-Whitney test. To explore how the intervention worked, 24 qualitative focus groups were conducted following the intervention.
RESULTS


The quantitative test did not show a significant intervention effect on stigma between intervention and control groups. Qualitative evidence reported new awareness and changed behaviour related to HIV- and TB-stigma among individual HCWs, but a combination of factors including strong social hierarchies in the workplace and the down-scaling of the original version of the intervention seemed to reduce the impact. Conclusion The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.",2020,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","['652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018', 'healthcare co-workers in South Africa', 'Eight hospitals in the Free State province']",[],"['HIV and TB stigma', 'Reducing HIV- and TB-Stigma', 'HIV- and TB-stigma among HCWs']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",652.0,0.0411659,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sommerland', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium. Electronic address: nina.sommerland@gmail.com.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Masquillier', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Rau', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Engelbrecht', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'Centre for Evaluation, Department Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Janse van Rensburg', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Wouters', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113450']
2168,33126100,A qualitative exploration of mechanisms of intimate partner violence reduction for zambian couples receiving the Common Elements Treatment Approach (CETA) intervention.,"RATIONALE


Despite well-established associations between alcohol use, poor mental health, and intimate partner violence (IPV), limited attention has been given to how psychological and behavioral interventions might prevent or treat IPV in low- and middle-income countries.
OBJECTIVE


In a recent randomized controlled trial in Lusaka, Zambia, transdiagnostic cognitive-behavioral psychotherapy (the Common Elements Treatment Approach; CETA) demonstrated significant treatment effects on men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female was reported. In this study, we sought to gain a more in-depth understanding of mechanisms of behavior change among CETA participants.
METHODS


We conducted 50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018. Transcripts were analyzed using an inductive constant comparison approach by a team of US- and Zambia-based coders.
RESULTS


Participants described interrelated mechanisms of change, including the use of safety strategies to not only avoid or prevent conflict but also to control anger; reductions in alcohol use that directly and indirectly reduced conflict; and, positive changes in trust and understanding of one's self and their partner. Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
CONCLUSIONS


Results suggest important avenues for future research including the potential for combining CETA with poverty reduction or gender norms focused interventions and for incorporating cognitivebehavioral skills into community level interventions.",2020,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","['CETA participants', ""men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female"", '50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018', 'zambian couples receiving the Common Elements Treatment Approach (CETA) intervention']",[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.0260064,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA. Electronic address: Sarah.murray@jhu.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski Van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Saphira Munthali', 'Initials': 'SM', 'LastName': 'Mulemba', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Mwamba M', 'Initials': 'MM', 'LastName': 'Mwenge', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Alto', 'Affiliation': 'University of Rochester, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113458']
2169,33126310,"Efficacy of DA-5204 (Stillen 2X) for patients with gastroesophageal reflux disease: A randomized, double-blind, placebo-controlled pilot study.","BACKGROUND/AIM


Proton pump inhibitor (PPI) alone is not satisfactory for the treatment of gastroesophageal reflux disease (GERD). Therefore, we investigated the efficacy of DA-5204 (Stillen 2X, 90 mg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy on GERD in comparison to PPI alone.
METHODS


This randomized, double-blind, placebo-controlled study randomly assigned 70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups: pantoprazole 40 mg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40 mg once daily with placebo twice daily (placebo group) for 4 weeks. The primary endpoint was endoscopic healing rate. The secondary endpoint was sufficient relief (≥50% reduction) of symptoms using GERD Questionnaire.
RESULTS


Final analyses included 29 patients with the DA-5204 group and 30 patients with the placebo group. At weeks 4, there was no significant difference in the endoscopic healing rate between the 2 groups (DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000). However, the rate of residual minimal change was significantly lower in the DA-5204 group (5/28, 17.9%) than in the placebo group (17/28, 60.7%) (P < .001). The rates of symptom relief were not different between the DA-5204 group and the placebo group (all P > .05).
CONCLUSION


Combined therapy with PPI and DA-5204 has no additional effect on the endoscopic healing rate compared to PPI alone. However, it may be beneficial in resolving minimal change.",2020,DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000).,"['gastroesophageal reflux disease (GERD', '70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups', '29 patients with the DA-5204 group and 30 patients with the placebo group', 'patients with gastroesophageal reflux disease']","['Proton pump inhibitor (PPI) alone', 'DA-5204 (Stillen 2X', 'DA-5204 (Stillen 2X, 90\u200amg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy', 'pantoprazole 40\u200amg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40\u200amg once daily with placebo twice daily (placebo', 'DA-5204 vs placebo', 'placebo']","['endoscopic healing rate', 'rates of symptom relief', 'sufficient relief', 'rate of residual minimal change']","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4279632', 'cui_str': 'Stillen'}, {'cui': 'C0331308', 'cui_str': 'Artemisia'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1126048', 'cui_str': 'pantoprazole 40 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",70.0,0.318746,DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000).,"[{'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022729']
2170,33126374,Clinical nursing pathway improves the nursing satisfaction in patients with acute cerebral hemorrhage: A randomized controlled trial protocol.,"BACKGROUND


Cerebral hemorrhage (CH) is a very common cerebrovascular disorder in clinical practice. More and more studies reported that proper nursing care could promote the rate of treatment, and improve the prognosis after treatment. Clinical nursing pathway (CNP) refers to original nursing mode with good quality, outstanding efficiency, and low treatment spending. Few articles have reported the effect of CNP in patients with acute CH. The program is in urgent need of convinced evidence to prove the reliability. Thus, we perform this randomized controlled trial protocol and hypothesize that CNP is associated with improved outcomes and nursing satisfaction, reduced adverse reactions in patients with acute CH.
METHOD


It is a single-center randomized controlled study to be conducted from October 2020 to October 2021. It was admitted via the Ethics Committee of the West China Hospital of Sichuan University (0038842/121). Eighty patients meet diagnostic standards for CH are included. The study group receives the clinical nursing path model. In the control group, patients receive the routine care before and after taking to the hospital. The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups. Six months after admission, the functional independence measure and Fugl Meyer score are recorded. All data are analyzed by the IBM SPSS Statistics, version 20 (IBM Corp., Armonk, NY edition).
RESULTS


Table 1 shows the clinical outcomes between groups.
CONCLUSION


CNP may improve the clinical outcomes for patients with acute CH and have a significant value in actual applications.
TRIAL REGISTRATION NUMBER


researchregistry6061.",2020,"The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups.","['patients with acute cerebral hemorrhage', 'Eighty patients meet diagnostic standards for CH are included', 'October 2020 to October 2021', 'patients with acute CH']",['CNP'],"['adverse reactions', 'functional independence measure and Fugl Meyer score', 'IBM SPSS Statistics, version 20 (IBM Corp., Armonk, NY edition', ""Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",80.0,0.0785752,"The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups.","[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Nursing, West China Hospital of Sichuan University/West China Nursing College, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022989']
2171,33126375,Comparison anterior minimally invasive oblique retroperitoneal approach and posterior transpedicular approach for debridement fusion in patients with lumbar vertebral osteomyelitis: A randomized controlled trial protocol.,"BACKGROUND


Pyogenic osteomyelitis of the spine usually occurs in patients over 55 years old with acute osteomyelitis. Surgical treatment and fixation can relieve pain, enhance spinal balance and nerve function, so that patients can walk as soon as possible. Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA). While, there is no consensus on the best treatment for PVO. The goal of the protocol is to compare the clinical consequences between PTA and ORA for treating PVO.
METHOD


The experiment is a single-center randomized clinical research. This experiment was admitted by the Ethics Committee of the People's Hospital of Dayi County (Approval number: 1002-084). In all, 50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study. We contain adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO. Cases are removed if there is previous hardware placement, cases who are not confirmed by microbiology, or severe renal and liver dysfunction. The primary outcomes are intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion. The secondary outcomes are postoperative pain score and physical recovery. SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA) is used for data analysis.
RESULTS


Table 1 will show the outcomes in both groups.
CONCLUSION


This protocol may offer a reliable basis for the effectiveness of the two approaches in the treatment of PVO.
TRIAL REGISTRATION NUMBER


researchregistry6046.",2020,Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA).,"['adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO', 'patients with lumbar vertebral osteomyelitis', 'patients over 55 years old with acute osteomyelitis', '50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study']","['surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA', 'Comparison anterior minimally invasive oblique retroperitoneal approach and posterior transpedicular approach', 'Surgical treatment and fixation']","['pain, enhance spinal balance and nerve function', 'SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA', 'intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion', 'postoperative pain score and physical recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0158371', 'cui_str': 'Acute osteomyelitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205502', 'cui_str': 'Retroperitoneal approach'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442371', 'cui_str': 'Transpedicular approach'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.145126,Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wan', 'Affiliation': ""Department of Stomatology, The People's Hospital of Dayi County, Chengdu, Sichuan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Yangbin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics.'}]",Medicine,['10.1097/MD.0000000000022990']
2172,33126401,Exposure of Biomimetic Composite Materials to Acidic Challenges: Influence on Flexural Resistance and Elastic Modulus.,"Acidic conditions of the oral cavity, including soft drinks and cariogenic bacteria, represent a damage for restorative biomimetic composite materials. The aim of this study is to assess the influence of two different acidic challenges on the flexural strength and elastic modulus of five composites: x-tra fil (Group 1, XTF), GrandioSO x-tra (Group 2, GXT), Admira Fusion x-tra (Group 3, AFX), VisCalor bulk (Group 4, VCB), and Enamel Plus HRi (Group 5, EPH). Thirty samples for each group were randomly divided and assigned to three different treatments: storage in distilled water as the controls (subgroups 1a-5a), 3 weeks distilled water + 1 week Coca-Cola (subgroups 1b-5b), and 4 weeks Coca-Cola (subgroups 1c-5c). For each subgroup, the flexural strength and elastic modulus were measured using an Instron universal testing machine, and data were submitted to statistical analysis. Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p  > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p  < 0.05). AFX reported the lowest flexural strength among the materials tested. As regards the elastic modulus, no material showed a significant variation after acidic storages when compared with the respective control ( p  > 0.05). AFX and EPH reported the lowest elastic modulus compared to the other materials. All composites tested showed adequate flexural properties according to the standards, except for AFX. This biomimetic material, along with EPH, might be indicated for V class (cervical) restorations considering the lowest values of elasticity reported.",2020,"Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p  > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p  < 0.05).",['Exposure of Biomimetic Composite Materials to Acidic Challenges'],"['AFX and EPH', 'AFX', 'tra fil (Group 1, XTF), GrandioSO x-tra (Group 2, GXT), Admira Fusion x-tra (Group 3, AFX), VisCalor bulk (Group 4, VCB), and Enamel Plus HRi']","['adequate flexural properties', 'lowest flexural strength', 'flexural strength', 'Flexural Resistance and Elastic Modulus', 'flexural strength and elastic modulus']","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0872312', 'cui_str': 'Bio-inspired Engineering'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0908506', 'cui_str': 'Eph Family Receptors'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1313391', 'cui_str': 'admira'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}]",,0.0159474,"Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p  > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p  < 0.05).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scribante', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Scarantino', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dagna', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Poggio', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}]","Biomimetics (Basel, Switzerland)",['10.3390/biomimetics5040056']
2173,33126534,"The Metabolic Effects of  Cynara  Supplementation in Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.","Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of  Cynara scolymus  (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA) in overweight subjects with newly diagnosed IFG. Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2) were randomly assigned to the supplemented group ( n  = 27) and placebo ( n  = 27). After multiple testing correction, statistically significant interactions between time and group were observed for the primary endpoint glycemia (β = 0.36,  p  < 0.0001) and for the secondary endpoints HDL (β = -0.10,  p  < 0.0001), total cholesterol/HDL (β = 0.27,  p  < 0.0001), LDL (β = 0.15,  p  = 0.005), LDL/HDL (β = 0.23,  p  = 0.001), insulin (β = 1.28,  p  = 0.04), glycated hemoglobin (β = 0.21,  p  = 0.0002), A1c-derived average glucose (β = 0.34,  p  = 0.0002), ApoB (β = 6.00,  p  = 0.01), ApoA (β = -4.50,  p  = 0.04), ApoB/ApoA (β = 0.08,  p  = 0.003), waist circumference (β = 1.89,  p  = 0.05), VATβ = 222.37,  p  = 0.005). In conclusion, these results confirm that Cs supplementation has a significant effect on metabolic parameters in IFG patients.",2020,"p  = 0.04), glycated hemoglobin (β = 0.21,  p  = 0.0002), A1c-derived average glucose (β = 0.34,  p  = 0.0002), ApoB (β = 6.00,  p  = 0.01),","['Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2', 'overweight subjects with newly diagnosed IFG', 'IFG patients', 'Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia']","['placebo', 'Placebo', 'Cynara  Supplementation']","['total cholesterol/HDL', 'Impaired fasting glucose (IFG', 'waist circumference', 'primary endpoint glycemia', 'glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA', 'metabolic parameters', 'glycated hemoglobin']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853264', 'cui_str': 'Obese class I'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0771144', 'cui_str': 'Cynara Preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0377800', 'cui_str': 'protein B'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",54.0,0.147889,"p  = 0.04), glycated hemoglobin (β = 0.21,  p  = 0.0002), A1c-derived average glucose (β = 0.34,  p  = 0.0002), ApoB (β = 6.00,  p  = 0.01),","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, 27100 Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, Sakhir Campus, College of Science, University of Bahrain, Sakheer P.O. Box 32038, Bahrain.'}]",Nutrients,['10.3390/nu12113298']
2174,33122344,"Early Response to First-Line Anti-PD-1 Treatment in Hodgkin Lymphoma: A PET-Based Analysis from the Prospective, Randomized Phase II NIVAHL Trial.","PURPOSE


A primary analysis of the ongoing NIVAHL trial demonstrated unexpectedly high interim complete response rates to nivolumab-based first-line treatment in early-stage unfavorable Hodgkin lymphoma. However, biomarkers such as metabolic tumor volume (MTV) or total lesion glycolysis (TLG) and their change under treatment (∆MTV and ∆TLG), measured on positron emission tomography (PET), might provide additional relevant information for response assessment in this setting. Hence, the present analysis aimed to investigate early response to checkpoint inhibitor therapy beyond conventional criteria.
PATIENTS AND METHODS


NIVAHL is a prospective, randomized phase II trial that recruited between April 2017 and October 2018. Patients in arm A and B were assessed for early treatment response after 2 courses of doxorubicin, vinblastine, and dacarbazine with 2 concomitant nivolumab infusions per cycle (N-AVD) and 4×nivolumab, respectively. In the present analysis, we included all 59 individuals with PET images available to the central review panel for quantitative analysis before April 30, 2019.
RESULTS


At interim restaging, we determined a mean ∆MTV and ∆TLG of -99.8% each in arm A after 2×N-AVD, compared with -91.4% and -91.9%, respectively, for treatment group B undergoing 4×nivolumab. This high decrease in MTV and TLG was observed regardless of the initial lymphoma burden.
CONCLUSIONS


Our study showed that nivolumab-based first-line treatment leads to rapid near-complete reduction of tumor metabolism in early-stage unfavorable Hodgkin lymphoma. Thus, PET-derived biomarkers might allow reduction or even omission of chemo- and radiotherapy. Furthermore, MTV and TLG could be also used to optimize immune checkpoint-targeting treatments in other cancers.",2020,"This high decrease in MTV and TLG was observed regardless of the initial lymphoma burden.
","['early-stage unfavorable Hodgkin lymphoma', '59 individuals with PET images available to the central review panel for quantitative analysis before April 30, 2019', 'recruited between April 2017 and October 2018', 'Hodgkin Lymphoma']","['doxorubicin, vinblastine, and dacarbazine', '4×nivolumab', 'nivolumab-based first-line treatment', 'First-Line Anti-PD-1 Treatment']","['MTV and TLG', 'mean ∆MTV and ∆TLG', 'positron emission tomography (PET', 'metabolic tumor volume (MTV) or total lesion glycolysis (TLG) and their change under treatment (∆MTV and ∆TLG']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.0366924,"This high decrease in MTV and TLG was observed regardless of the initial lymphoma burden.
","[{'ForeName': 'Conrad-Amadeus', 'Initials': 'CA', 'LastName': 'Voltin', 'Affiliation': 'University of Cologne.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Mettler', 'Affiliation': 'University of Cologne.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'van Heek', 'Affiliation': 'Nuclear medicine, University of Cologne.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), University of Cologne.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiation Oncology and CyberKnife Center, University Hospital Cologne.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keller', 'Affiliation': 'Hematology and Oncology (CBF), Charite - Universitätsmedizin Berlin.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'Internal Medicine V, University of Heidelberg Hospital.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Trautmann-Grill', 'Affiliation': 'Medical Department I, Dresden University of Technology.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kerkhoff', 'Affiliation': 'Department of Medicine A, University Hospital Muenster.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group, University of Cologne.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'Clinic for Hematology/Oncology, Georg August University of Göttingen.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'Clinic for Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany, University of Duisburg-Essen.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Cologne.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'University of Cologne.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'Internal Medicine I, University Hospital Cologne.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'Department for Nuclear Medicine, University Hospital Cologne.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bröckelmann', 'Affiliation': 'University of Cologne paul.broeckelmann@uk-koeln.de.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3303']
2175,33122393,Small Amounts of Dietary Medium-Chain Fatty Acids Protect Against Insulin Resistance During Caloric Excess in Humans.,"Medium-chain fatty acids (MCFAs) have in rodents been shown to have protective effects on glucose homeostasis during high-fat overfeeding. In this study, we investigated whether dietary MCFAs protect against insulin resistance induced by a hypercaloric high-fat diet in humans. Healthy, lean men ingested a eucaloric control diet and a three-day hypercaloric high-fat diet (+75% energy, 81-83E% fat) in randomized order. For one group (n=8), the high-fat diet was enriched with saturated long-chain FAs (LCSFA-HFD), while the other group (n=9) ingested a matched diet, but with ∼30 g (5E%) saturated MCFAs (MCSFA-HFD) in substitution for a corresponding fraction of the saturated LCFAs. A hyperinsulinemic-euglycemic clamp with femoral arteriovenous balance and glucose tracer was applied after the control and hypercaloric diets. In LCSFA-HFD, whole body insulin sensitivity and peripheral insulin-stimulated glucose disposal were reduced. These impairments were prevented in MCSFA-HFD, accompanied by increased basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal related to lower starting glycogen content and increased glycogen synthase activity, together with increased muscle lactate production. In conclusion, substitution of a small amount of dietary LCFAs with MCFAs rescues insulin action in conditions of lipid-induced energy excess.",2020,"These impairments were prevented in MCSFA-HFD, accompanied by increased basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal related to lower starting glycogen content and increased glycogen synthase activity, together with increased muscle lactate production.","['Healthy, lean men ingested a', 'humans', 'Humans']","['hyperinsulinemic-euglycemic clamp with femoral arteriovenous balance and glucose tracer', 'Medium-chain fatty acids (MCFAs', 'high-fat diet was enriched with saturated long-chain FAs (LCSFA-HFD), while the other group (n=9) ingested a matched diet, but with ∼30 g (5E%) saturated MCFAs (MCSFA-HFD', 'dietary MCFAs', 'Dietary Medium-Chain Fatty Acids Protect Against Insulin Resistance', 'eucaloric control diet and a three-day hypercaloric high-fat diet']","['basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal', 'glycogen synthase activity', 'body insulin sensitivity and peripheral insulin-stimulated glucose disposal', 'muscle lactate production']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0522094', 'cui_str': 'Medium chain fatty acid'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017932', 'cui_str': 'Glycogen (starch) synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0199802,"These impairments were prevented in MCSFA-HFD, accompanied by increased basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal related to lower starting glycogen content and increased glycogen synthase activity, together with increased muscle lactate production.","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Lundsgaard', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fritzen', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Sjøberg', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Kleinert', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Richter', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Kiens', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. bkiens@nexs.ku.dk.'}]",Diabetes,['10.2337/db20-0582']
2176,33122421,Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.,"BACKGROUND


The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.
METHODS AND ANALYSIS


PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.
TRIAL REGISTRATION NUMBER


NCT04144881.",2020,"Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome.","['Consecutive patients treated with', 'patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents']","['CT coronary', 'PCI', 'planned angiographic control (PAC', 'Angiographic control versus ischaemia-driven management']","['Major adverse cardiovascular events', 'renal failure and bleeding events', 'death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis', 'unplanned target lesion revascularisation (TLR) and TLR driven by PAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",550.0,0.16451,"Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome.","[{'ForeName': 'Ovidio', 'Initials': 'O', 'LastName': 'De Filippo', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy ovidio.defilippo@gmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bianco', 'Affiliation': 'Division of Cardiology, San Luigi Gonzaga University Hospital, Orbassano, Italy, Orbassano, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Iannaccone', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gaido', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Diseases, AUSL Romagna, Degli Infermi Hospital, Rimini, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zaccaro', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Depaoli', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vaudano', 'Affiliation': 'Radiology Unit, San Giovanni Bosco Hospital, Turin, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Quadri', 'Affiliation': 'Cardiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gagnor', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Boccuzzi', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Solitro', 'Affiliation': 'Radiology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Cortese', 'Affiliation': 'Radiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Guarnaccia', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tore', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Veltri', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Italy, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Franchin', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Angelini', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Garbo', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Giammaria', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Cardiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Marchisio', 'Affiliation': 'Radiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fonio', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Cerrato', 'Affiliation': 'Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, RIvoli, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Division of Cardiology, Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Ascenzo"", 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}]",Open heart,['10.1136/openhrt-2020-001253']
2177,33122573,Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND


Desaturation is a common complication of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Dexmedetomidine (DEX), a commonly used sedative in intensive care, is associated with less respiratory depression compared with other sedatives.
OBJECTIVE


We compared DEX with midazolam (MDZ) when used as a sedative during EBUS-TBNA.
DESIGN


A randomised, parallel, double-blinded trial.
SETTING


A university-affiliated teaching hospital between June 2014 and July 2015 PATIENTS: A total of 102 patients who underwent EBUS-TBNA were randomly allocated to two groups (48 DEX group, 54 MDZ group).
INTERVENTIONS


DEX group received 0.25 to 0.75 μg kg h (start with 0.5 μg kg h, modulated in three steps from 0.25 to 0.75 μg kg h) of DEX after a loading dose of 0.25 μg kg h for 10 min to maintain a Ramsay Sedation Scale (RSS) of 3to 5. If the patient was agitated, 1 mg of MDZ bolus was used as a rescue drug. Patients in the MDZ group initially received 0.05 mg kg of MDZ as a bolus. For maintenance and rescue, 1 mg of MDZ bolus was used.
MAIN OUTCOME MEASURES


The primary outcome was the presence of oxygen desaturation. Secondary outcomes were level of sedation (Ramsay Sedation Scale score), cough score, sedation and procedure satisfaction score.
RESULTS


The baseline characteristics of the patients, duration of EBUS-TBNA procedures and the use of rescue MDZ were not different between the groups. There was no significant difference in desaturation events between the DEX and MDZ groups (56.3 and 68.5%, respectively; P = 0.20). The level of sedation and the sedation satisfaction scores were similar between the two groups. However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02).
CONCLUSION


The use of DEX during EBUS-TBNA was not superior to MDZ in terms of oxygen desaturation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02157818.",2020,"However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02).
","['sedation during endobronchial ultrasound-guided transbronchial needle aspiration', 'A university-affiliated teaching hospital between June 2014 and July 2015 PATIENTS', '102 patients who underwent EBUS-TBNA']","['endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'DEX', 'DEX and MDZ', 'Dexmedetomidine', 'DEX with midazolam (MDZ', 'midazolam', 'Dexmedetomidine (DEX', 'MDZ']","['presence of oxygen desaturation', 'cough score', 'desaturation events', 'level of sedation (Ramsay Sedation Scale score), cough score, sedation and procedure satisfaction score', 'level of sedation and the sedation satisfaction scores']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",102.0,0.397868,"However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02).
","[{'ForeName': 'Junghyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'From the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine (JK, SMC, YSP, C-HL, S-ML, CGY,YWK, JL), Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, Republic of Korea (JK).'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Chang-Hoon', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Chul-Gyu', 'Initials': 'CG', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Young Whan', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jinwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001370']
2178,33122574,Ultrasound increases the success rate of spinal needle placement through the epidural needle during combined spinal-epidural anaesthesia: A randomised controlled study.,"BACKGROUND


Combined spinal-epidural anaesthesia (CSEA) using a needle-through-needle technique is currently widely used. However, successful epidural needle placement does not mean a successful spinal needle placement during CSEA. Whether ultrasound assistance could increase the first-pass success rate of spinal needle placement for CSEA remains unknown.
OBJECTIVE


The aim of this study was to investigate if ultrasound assistance could increase the first-pass success rate of spinal needle placement through the epidural needle during CSEA performed by experienced anaesthesiologists in patients undergoing caesarean section.
DESIGN


A prospective, randomised, controlled, double-blind study.
SETTING


Single centre, Department of Anaesthesiology, Shengjing Hospital, China Medical University, China, from June 2019 to September 2019.
PATIENTS


A total of 185 patients (aged 24 years to 52 years, American Society of Anesthesiologists grade (ASA) II-III, 38 to 40 weeks gestation) scheduled to undergo elective caesarean section under CSEA were enrolled.
INTERVENTION


The patients were randomised to either an ultrasound group (patients received a preprocedural ultrasound scan, and the puncture site was identified by ultrasound imaging) and a palpation group (patients received a sham procedural ultrasound scan, and the puncture site was identified by conventional palpation).MAIN OUTCOME MEASURES The primary outcome measure was the first-pass success rate for spinal needle placement through the epidural needle. Secondary outcome measures were total duration of CSEA, time required for successful epidural needle and spinal needle placement, number of epidural needle redirections and complications.
RESULTS


Preprocedural ultrasound imaging significantly increased the first-pass success rate of spinal needle placement through the epidural needle compared with conventional palpation (93.8 vs. 68.8%, P < 0.001). Preprocedural ultrasound imaging also decreased the total duration of CSEA (186.9 ± 37.1 vs. 213 ± 60.4 s, P = 0.0015) and the time required for successful spinal needle placement (78.3 ± 22.9 vs. 100.1 ± 53.7 s, P < 0.01) compared with conventional palpation. Fewer patients in the ultrasound group needed epidural needle redirections during the spinal needle placement procedure than in the palpation group (four patients vs. 20 patients, P < 0.01).
CONCLUSION


For experienced anaesthesiologists, preprocedural ultrasound imaging significantly increased the first-pass success rate of spinal needle placement through the epidural needle for obstetric patients undergoing caesarean section under CSEA.
TRIAL REGISTRATION


chictr.org.cn, identifier: ChiCTR1900024132.",2020,"Fewer patients in the ultrasound group needed epidural needle redirections during the spinal needle placement procedure than in the palpation group (four patients vs. 20 patients, P < 0.01).
","['185 patients (aged 24 years to 52 years, American Society of Anesthesiologists grade (ASA) II-III, 38 to 40 weeks gestation) scheduled to undergo elective caesarean section under CSEA were enrolled', 'patients undergoing caesarean section', 'Single centre, Department of Anaesthesiology, Shengjing Hospital, China Medical University, China, from June 2019 to September 2019', 'obstetric patients undergoing caesarean section under CSEA']","['spinal-epidural anaesthesia (CSEA', 'ultrasound group (patients received a preprocedural ultrasound scan, and the puncture site was identified by ultrasound imaging) and a palpation group (patients received a sham procedural ultrasound scan', 'epidural needle', 'spinal needle placement through the epidural needle during CSEA', 'ultrasound assistance']","['total duration of CSEA, time required for successful epidural needle and spinal needle placement, number of epidural needle redirections and complications', 'first-pass success rate of spinal needle placement', 'time required for successful spinal needle placement', 'epidural needle redirections', 'total duration of CSEA', 'first-pass success rate for spinal needle placement through the epidural needle', 'success rate of spinal needle placement']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0181970', 'cui_str': 'Epidural needle'}, {'cui': 'C0181982', 'cui_str': 'Spinal needle'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0181970', 'cui_str': 'Epidural needle'}, {'cui': 'C0181982', 'cui_str': 'Spinal needle'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444693', 'cui_str': 'First pass'}]",185.0,0.032372,"Fewer patients in the ultrasound group needed epidural needle redirections during the spinal needle placement procedure than in the palpation group (four patients vs. 20 patients, P < 0.01).
","[{'ForeName': 'Bingdong', 'Initials': 'B', 'LastName': 'Tao', 'Affiliation': 'From the Department of Anaesthesiology, Shengjing hospital of China Medical University, Shenyang, China (BT, KL, MD, HX, XL, PZ).'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Xingyue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001380']
2179,33047689,Role of acoustic radiation force-based elasticity imaging in endometrium pathologies.,"Backround


Ultrasonography is difficult to distinguish between endometrial pathologies and often requires curettage. ARFI (Acoustic Radiation Force-Based Elasticity Imaging) is a new ultrasonography elastography method. Using ARFI, it is possible to obtain information about the likelihood of the tissue benign or malignant.
Aim


The aim of this study is to evaluate the contribution of ARFI to differentiate endometrial pathologies in hysterectomy specimens.
Subjects and Methods


Our study was prospectively, January-May 2017, performed in randomly 45 cases of 41-91 years of age (mean 58.3 years) who have decided to have hysterectomy. Hysterectomy was performed for uterine prolapse and endometrial hyperplasia in elderly patients and menorrhagia in young patients. Pathology results were compared with ARFI values and endometrial thickness. ANNOVA test was used for the comparison of ARFI values.
Results


Pathology revealed 14 cases of endometrial atrophy, 11 cases of proliferative phase, 10 cases of polyp, 6 cases of endometrial hyperplasia, and 4 cases of endometrium cancer. There is a statistically significant difference between mean ARFI values of endometrium, subendometrium, and myometrium of the groups (P < 0.05). There was a statistically significant difference between the mean endometrial thickness of the groups (P < 0.05).
Conclusion


Endometrium ARFI contributes to the differential diagnosis of endometrial pathologies. Subendometrial and myometrial ARFI values decrease in polyps and increase in hyperplasia. Our study shows that the addition of subendometrium ARFI to gray-scale sonography before deciding on invasive procedures in endometrial pathologies may improve diagnostic accuracy. We concluded that further in vivo studies will establish the usefulness of this technique for preoperative diagnostic measures.",2020,"There was a statistically significant difference between the mean endometrial thickness of the groups (P < 0.05).
","['elderly patients and menorrhagia in young patients', 'endometrium pathologies', 'Subjects and Methods', 'January-May 2017, performed in randomly 45 cases of 41-91 years of age (mean 58.3 years) who have decided to have hysterectomy']","['ARFI (Acoustic Radiation Force-Based Elasticity Imaging', 'acoustic radiation force-based elasticity imaging', 'Hysterectomy', 'subendometrium ARFI']","['mean ARFI values of endometrium, subendometrium, and myometrium', 'hyperplasia', 'ARFI values and endometrial thickness', 'mean endometrial thickness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0175142,"There was a statistically significant difference between the mean endometrial thickness of the groups (P < 0.05).
","[{'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Cenkeri', 'Affiliation': 'Department of Radiology, Okan University, Istanbul, Turkey.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Bidaci', 'Affiliation': 'Department of Obstetrics and Gynecology, Baskent University, Istanbul, Turkey.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Radiology, Okan University, Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Desteli', 'Affiliation': 'Department of Obstetrics and Gynecology, Baskent University, Istanbul, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_589_18']
2180,33122670,Circadian misalignment increases mood vulnerability in simulated shift work.,"Night shift work can associate with an increased risk for depression. As night workers experience a 'misalignment' between their circadian system and daily sleep-wake behaviors, with negative health consequences, we investigated whether exposure to circadian misalignment underpins mood vulnerability in simulated shift work. We performed randomized within-subject crossover laboratory studies in non-shift workers and shift workers. Simulated night shifts were used to induce a misalignment between the endogenous circadian pacemaker and sleep/wake cycles (circadian misalignment), while environmental conditions and food intake were controlled. Circadian misalignment adversely impacted emotional state, such that mood and well-being levels were significantly decreased throughout 4 days of continuous exposure to circadian misalignment in non-shift workers, as compared to when they were under circadian alignment (interaction of ""circadian alignment condition"" vs. ""day"", mood: p < 0.001; well-being: p < 0.001; adjusted p-values). Similarly, in shift workers, mood and well-being levels were significantly reduced throughout days of misalignment, as compared to circadian alignment (interaction of ""circadian alignment condition"" vs. ""day"", mood: p = 0.002; well-being: p = 0.002; adjusted p-values). Our findings indicate that circadian misalignment is an important biological component for mood vulnerability, and that individuals who engage in shift work are susceptible to its deleterious mood effects.",2020,"Circadian misalignment adversely impacted emotional state, such that mood and well-being levels were significantly decreased throughout 4 days of continuous exposure to circadian misalignment in non-shift workers, as compared to when they were under circadian alignment (interaction of ""circadian alignment condition"" vs. ""day"", mood: p < 0.001; well-being: p < 0.001; adjusted p-values).",['non-shift workers and shift workers'],['Circadian misalignment'],"['emotional state, such that mood and well-being levels']","[{'cui': 'C0425104', 'cui_str': 'Shift worker'}]","[{'cui': 'C1275957', 'cui_str': 'Misalignment'}]","[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.025589,"Circadian misalignment adversely impacted emotional state, such that mood and well-being levels were significantly decreased throughout 4 days of continuous exposure to circadian misalignment in non-shift workers, as compared to when they were under circadian alignment (interaction of ""circadian alignment condition"" vs. ""day"", mood: p < 0.001; well-being: p < 0.001; adjusted p-values).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Chellappa', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA. sarah.chellappa@outlook.com.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA.""}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, 02115, USA. fscheer@bwh.harvard.edu.""}]",Scientific reports,['10.1038/s41598-020-75245-9']
2181,33122892,Pharmacokinetic/Pharmacodynamic Interaction Between Evogliptin and Pioglitazone in Healthy Male Subjects.,"Aim


Evogliptin is a newly developed oral glucose-lowering medication of the dipeptidyl peptidase 4 (DPP-4) inhibitor class for type 2 diabetes mellitus. The combination of a DPP-4 inhibitor with pioglitazone is a promising therapeutic option. The aim of the present study was to evaluate the pharmacokinetic and pharmacodynamic interaction between evogliptin and pioglitazone.
Materials and Methods


A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence crossover study was conducted in healthy Korean male subjects. All subjects received evogliptin 5 mg once daily for 7 days (EVO), pioglitazone 30 mg once daily for 7 days (PIO) and co-administration of evogliptin 5 mg and pioglitazone 30 mg once daily for 7 days (EVO+PIO) according to the assigned sequence and period. Serial blood samples were collected for 24 hours for pharmacokinetic analysis and 3 hours after the oral glucose tolerance test for the pharmacodynamic analysis.
Results


Thirty-four subjects completed the study. EVO+PIO and EVO showed a similar maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve during the dosing interval at the steady state (AUC τ,ss ) of evogliptin, with geometric mean ratios (GMRs) (90% confidence interval (CI)) of 1.01 (0.97-1.05) and 1.01 (0.98-1.04), respectively. EVO+PIO and PIO showed a similar C max,ss  and AUC τ,ss  of pioglitazone, with GMRs (90% CI) of 1.07 (0.99-1.17) and 1.08 (0.99-1.17), respectively. Reduction of the glucose level after EVO+PIO was larger compared to PIO and similar with EVO.
Conclusion


Concomitant administration of evogliptin and pioglitazone showed similar glucose-lowering effects with those of evogliptin alone without pharmacokinetic interactions when compared to the intake of each drug alone.",2020,"EVO+PIO and EVO showed a similar maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve during the dosing interval at the steady state (AUC τ,ss ) of evogliptin, with geometric mean ratios (GMRs) (90% confidence interval (CI)) of 1.01 (0.97-1.05) and 1.01 (0.98-1.04), respectively.","['type 2 diabetes mellitus', 'Healthy Male Subjects', 'Results\n\n\nThirty-four subjects completed the study', 'healthy Korean male subjects']","['Evogliptin and Pioglitazone', 'evogliptin and pioglitazone', 'DPP-4 inhibitor with pioglitazone', 'pioglitazone', 'evogliptin 5 mg once daily for 7 days (EVO), pioglitazone 30 mg once daily for 7 days (PIO) and co-administration of evogliptin 5 mg and pioglitazone']","['geometric mean ratios (GMRs', 'EVO+PIO and PIO', 'glucose level after EVO+PIO', 'pharmacokinetic and pharmacodynamic interaction', 'maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1127433', 'cui_str': 'pioglitazone 30 MG'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1127433', 'cui_str': 'pioglitazone 30 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030800', 'cui_str': 'Pemoline'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1868979', 'cui_str': 'Pharmacodynamic interaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0430859,"EVO+PIO and EVO showed a similar maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve during the dosing interval at the steady state (AUC τ,ss ) of evogliptin, with geometric mean ratios (GMRs) (90% confidence interval (CI)) of 1.01 (0.97-1.05) and 1.01 (0.98-1.04), respectively.","[{'ForeName': 'Inyoung', 'Initials': 'I', 'LastName': 'Hwang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyounggyoon', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S275336']
2182,33122899,"Hypnosis for the Management of Anxiety and Dyspnea in COPD: A Randomized, Sham-Controlled Crossover Trial.","Background


Patients with chronic obstructive pulmonary disease (COPD) are prone to dyspnea, increased respiratory rate and other anxiety-inducing symptoms. Hypnosis constitutes a complementary procedure capable of improving subjective feelings of anxiety.
Objective


Assessing the efficacy of a 15-minute hypnosis intervention for immediate improvement of anxiety in severe COPD patients.
Methods


Twenty-one participants, COPD patients (mean FEV1 < 32.3%), were randomly assigned to two individual sessions in crossover (sham and hypnosis, 24-h washout period, arms: hypnosis-sham [n=11]/sham-hypnosis [n=10]). We tracked pre- and post-intervention anxiety (STAI-6 score) as primary endpoint.
Results


Nineteen (90.5%) participants completed the study. Anxiety diminished significantly after hypnosis (STAI-6 scores -23.8% [SD = 18.4%] hypnosis vs -3.1% [32.8%] sham; χ 2 =8, P<0.01, Bayes Factor 5.5). Respiratory rate also decreased after hypnosis. Improvements in SpO2 and Borg exertion scores were registered after both conditions.
Conclusion


A 15-minute hypnosis session improved participants' anxiety and lowered respiratory rate (as opposed to sham). Improvements in anxiety were correlated with an alleviation in respiratory strain. Results imply that hypnosis can contribute to the improvement of anxiety levels and breathing mechanics in severe COPD patients.
Registration Id


ISRCTN10029862.",2020,"Conclusion


A 15-minute hypnosis session improved participants' anxiety and lowered respiratory rate (as opposed to sham).","['\n\n\nPatients with chronic obstructive pulmonary disease (COPD', 'Anxiety and Dyspnea in COPD', 'severe COPD patients', 'Methods\n\n\nTwenty-one participants, COPD patients (mean FEV1 < 32.3']","['hypnosis intervention', 'Hypnosis', 'hypnosis-sham [n=11]/sham-hypnosis', 'hypnosis session']","['SpO2 and Borg exertion scores', 'Respiratory rate', 'anxiety levels and breathing mechanics', 'Anxiety', 'anxiety', ""participants' anxiety and lowered respiratory rate""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",21.0,0.182276,"Conclusion


A 15-minute hypnosis session improved participants' anxiety and lowered respiratory rate (as opposed to sham).","[{'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Anlló', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Herer', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Delignières', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Yolaine', 'Initials': 'Y', 'LastName': 'Bocahu', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Segundo', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Mach Alingrin', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Gilbert', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Larue', 'Affiliation': 'Clinical Hypnosis Research Team, Bligny Hospital Center, Briis-sous-Forges, France.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S267019']
2183,33122965,The influence of viewing a headline about ecstasy/Molly adulteration on future intentions to use.,"Background


Ecstasy (3,4-methylenedioxymethamphetamine [MDMA]), commonly referred to as Molly in the US, is commonly adulterated with drugs potentially more dangerous than MDMA. Synthetic cathinones (""bath salts"") are common adulterants, and use of these compounds tends to be stigmatized. We investigated whether presenting information on the extent of ecstasy being adulterated with ""bath salts"" affects intentions to use.
Methods


A total of 1,025 adults entering electronic dance music parties were surveyed in 2018. Using an experimental posttest-only design with random assignment, half were randomly assigned to view a published Vice headline about ecstasy/Molly commonly being adulterated with ""bath salts.""
Results


Overall, 30.5% of the sample reported past-year ecstasy use, and before viewing the headline, 16.4% agreed that ecstasy/Molly commonly contains ""bath salts."" While controlling for pre-test knowledge of ""bath salt"" adulteration, viewing the headline reduced the odds of intention to use ecstasy/Molly only among non-past-year ecstasy users (Odd ratio [OR] = 0.54;  p  = .048). Viewing the headline increased the odds (OR = 1.81,  p  = .030) of past-year ecstasy users' intention to test their ecstasy for adulterants.
Conclusions


Knowledge that ecstasy is commonly adulterated may help reduce the risk for future use among non-recent users and increase the willingness of users to test their ecstasy. This information can be used to target those at risk for ecstasy/Molly use.",2020,"Viewing the headline increased the odds (OR = 1.81,  p  = .030) of past-year ecstasy users' intention to test their ecstasy for adulterants.
","['1,025 adults entering electronic dance music parties were surveyed in 2018']","['\n\n\nEcstasy (3,4-methylenedioxymethamphetamine [MDMA', 'bath salts', 'Synthetic cathinones (""bath salts']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0054876', 'cui_str': 'cathinone'}]",[],1025.0,0.0678847,"Viewing the headline increased the odds (OR = 1.81,  p  = .030) of past-year ecstasy users' intention to test their ecstasy for adulterants.
","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Palamar', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Acosta', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'Center for Drug Use and HIV/HCV Research, New York University Rory Meyers College of Nursing, New York, NY, USA.'}]",Journal of substance use,['10.1080/14659891.2019.1664660']
2184,33123000,Predicting Antidepressant Citalopram Treatment Response via Changes in Brain Functional Connectivity After Acute Intravenous Challenge.,"Introduction:  The early and therapy-specific prediction of treatment success in major depressive disorder is of paramount importance due to high lifetime prevalence, and heterogeneity of response to standard medication and symptom expression. Hence, this study assessed the predictability of long-term antidepressant effects of escitalopram based on the short-term influence of citalopram on functional connectivity.  Methods:  Twenty nine subjects suffering from major depression were scanned twice with resting-state functional magnetic resonance imaging under the influence of intravenous citalopram and placebo in a randomized, double-blinded cross-over fashion. Symptom factors were identified for the Hamilton depression rating scale (HAM-D) and Beck's depression inventory (BDI) taken before and after a median of seven weeks of escitalopram therapy. Predictors were calculated from whole-brain functional connectivity, fed into robust regression models, and cross-validated.  Results:  Significant predictive power could be demonstrated for one HAM-D factor describing insomnia and the total score ( r  = 0.45-0.55). Remission and response could furthermore be predicted with an area under the receiver operating characteristic curve of 0.73 and 0.68, respectively. Functional regions with high influence on the predictor were located especially in the ventral attention, fronto-parietal, and default mode networks.  Conclusion:  It was shown that medication-specific antidepressant symptom improvements can be predicted using functional connectivity measured during acute pharmacological challenge as an easily assessable imaging marker. The regions with high influence have previously been related to major depression as well as the response to selective serotonin reuptake inhibitors, corroborating the advantages of the current approach of focusing on treatment-specific symptom improvements.",2020,"The regions with high influence have previously been related to major depression as well as the response to selective serotonin reuptake inhibitors, corroborating the advantages of the current approach of focusing on treatment-specific symptom improvements.","['major depressive disorder', 'Twenty nine subjects suffering from major depression were']","['citalopram', 'scanned twice with resting-state functional magnetic resonance imaging', 'citalopram and placebo']","['HAM-D factor describing insomnia and the total score', 'Brain Functional Connectivity', ""Hamilton depression rating scale (HAM-D) and Beck's depression inventory (BDI""]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0125606', 'cui_str': 'Cholinergic Differentiation Factor'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",29.0,0.0429751,"The regions with high influence have previously been related to major depression as well as the response to selective serotonin reuptake inhibitors, corroborating the advantages of the current approach of focusing on treatment-specific symptom improvements.","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Rischka', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Godber Mathis', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Unterholzner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Murray Bruce', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Michenthaler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Winkler-Pjrek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}]",Frontiers in computational neuroscience,['10.3389/fncom.2020.554186']
2185,33123205,Upadacitinib  versus  placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients.,"Background


In the randomized, phase III, global SELECT-COMPARE study, upadacitinib 15 mg demonstrated efficacy at week 12  versus  placebo and adalimumab with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX, which was maintained over 48 weeks. This post hoc analysis of SELECT-COMPARE reports the efficacy and safety of upadacitinib in Central and Eastern European (CEE) patients.
Methods


Patients were randomized 2:2:1 to upadacitinib 15 mg once daily, placebo, or adalimumab 40 mg every other week, and continued MTX. Efficacy and safety were assessed through 48 weeks. Primary endpoints were the achievement of ≥20% improvement in American College of Rheumatology response criteria and Disease Activity Score in 28 joints with C-reactive protein <2.6 responses at week 12 for upadacitinib  versus  placebo. No statistical comparisons were conducted.
Results


A total of 596 patients from 12 CEE countries were randomized. At week 12, a numerically greater proportion of patients receiving upadacitinib  versus  placebo or adalimumab achieved ≥20% improvement in American College of Rheumatology response criteria (72%  versus  33% and 59%), Disease Activity Score in 28 joints with C-reactive protein <2.6 (26%  versus  4% and 11%), low disease activity and remission, and improved physical function, with results maintained over 48 weeks. Upadacitinib treatment numerically inhibited structural progression  versus  placebo at week 26. Serious infection and herpes zoster rates were numerically higher with upadacitinib  versus  adalimumab (2.7  versus  1.7 and 2.3  versus  1.1 events/100 patient-years, respectively) over 48 weeks.
Conclusion


Consistent with the global population of patients with rheumatoid arthritis and an inadequate response to MTX, in CEE patients, upadacitinib 15 mg demonstrated clinical and functional improvements  versus  placebo and adalimumab, radiographic improvements  versus  placebo, and reasonable safety, over 48 weeks.",2020,"Serious infection and herpes zoster rates were numerically higher with upadacitinib  versus  adalimumab (2.7  versus  1.7 and 2.3  versus  1.1 events/100 patient-years, respectively) over 48 weeks.
","['patients with rheumatoid arthritis and inadequate response to MTX, which was maintained over 48 weeks', 'Central and Eastern European patients', '596 patients from 12 CEE countries', 'Central and Eastern European (CEE) patients', 'patients with rheumatoid arthritis']","['upadacitinib 15 mg once daily, placebo, or adalimumab 40 mg every other week, and continued MTX', 'methotrexate', 'placebo and adalimumab with methotrexate (MTX', 'MTX', 'placebo', 'upadacitinib  versus  adalimumab', 'placebo or adalimumab', 'Upadacitinib  versus  placebo or adalimumab with background methotrexate']","['low disease activity and remission, and improved physical function', 'achievement of ≥20% improvement in American College of Rheumatology response criteria and Disease Activity Score', 'Efficacy and safety', 'Serious infection and herpes zoster rates', 'Disease Activity Score', 'American College of Rheumatology response criteria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0046018', 'cui_str': '2-chloroethyl ethyl sulfide'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",596.0,0.401615,"Serious infection and herpes zoster rates were numerically higher with upadacitinib  versus  adalimumab (2.7  versus  1.7 and 2.3  versus  1.1 events/100 patient-years, respectively) over 48 weeks.
","[{'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Pavelka', 'Affiliation': 'Institute of Rheumatology and Department of Rheumatology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Szekanecz', 'Affiliation': 'Division of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Damjanov', 'Affiliation': 'University of Belgrade School of Medicine, Institute of Rheumatology, Belgrade, Serbia.'}, {'ForeName': 'Branimir', 'Initials': 'B', 'LastName': 'Anić', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Matija', 'Initials': 'M', 'LastName': 'Tomšič', 'Affiliation': 'Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Mazurov', 'Affiliation': 'North-Western State Medical University named after I.I. Mechnikov, St Petersburg, Russia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Maksimovic', 'Affiliation': 'AbbVie Biopharmaceuticals GmbH, Belgrade, Serbia.'}, {'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Nagy', 'Affiliation': 'AbbVie Global Medical Affairs, Rheumatology, Budapest, Hungary.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Świerkot', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Tzvetanka', 'Initials': 'T', 'LastName': 'Petranova', 'Affiliation': 'Department of Rheumatology, UMHAT St.Iv.Rilsky, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Veldi', 'Affiliation': 'East-Tallinn Central Hospital, Tallinn, Estonia.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Baranauskaitė', 'Affiliation': 'Department of Rheumatology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Codreanu', 'Affiliation': 'Center of Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Daina', 'Initials': 'D', 'LastName': 'Andersone', 'Affiliation': 'P. Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Drugs in context,['10.7573/dic.2020-7-5']
2186,33123324,"The combined effects of cholesteryl ester transfer protein ( CETP ) TaqIB gene polymorphism and canola, sesame and sesame-canola oils consumption on metabolic response in patients with diabetes and healthy people.","Introduction:  Cholesteryl ester transfer protein (CETP) is a key regulating enzyme in the lipid metabolism pathway, and its gene polymorphism may be a candidate for modulating the metabolic responses to dietary intervention. We thus examined whether the effects of the CETP TaqIB polymorphism on metabolic profiles were modified by dietary plant oils.  Methods:  This is a retrospective analysis of data collected during a randomized triple-blind cross over trial. A total of 95 patients with type 2 diabetes and 73 non-diabetes individuals completed a 9-weekof the intake of sesame, canola and sesame-canola oils. Blood samples were collected at the beginning and at the end of each intervention period for biochemical analysis. Genotyping was done using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method.  Results:  In diabetes patients, B1B1 homozygotes of the CETP TaqIB polymorphism compared with B2 carriers (B1B2 + B2B2) had significantly lower diastolic blood pressure, apoB and apoB: apoA-1,and higher Lp(a) after the intake of sesame-canola oil, as well as lower insulin and HOMA-IR after the intake of sesame oil. There was also a significant effect of genotype on adjusted changes of apoB, apoB: apoA-1, insulin, HOMA-IR and QUICKI. A significant genotype-dietary oils combined effects were observed for diastolic blood pressure, and LDL: HDL, TC: HDL and TG: HDL ratios in diabetes patients. No independent or combined effects of dietary oils and genotypes on outcomes were found in healthy people.  Conclusion:  There was a modulatory effect of the CETP TaqIB polymorphism on some metabolic traits in response to plant oils in patients with diabetes. Taken together, the intake of sesame-canola and canola oils showed more favorable effects in diabetes patients with B1B1 genotype. Future investigations are needed to confirm these results.",2020,"A significant genotype-dietary oils combined effects were observed for diastolic blood pressure, and LDL: HDL, TC: HDL and TG: HDL ratios in diabetes patients.","['diabetes patients', 'healthy people', 'diabetes patients with B1B1 genotype', '95 patients with type 2 diabetes and 73 non-diabetes individuals completed a', 'patients with diabetes', 'patients with diabetes and healthy people']","['cholesteryl ester transfer protein ( CETP ) TaqIB gene polymorphism and canola, sesame and sesame-canola oils consumption', '9-weekof the intake of sesame, canola and sesame-canola oils', 'Cholesteryl ester transfer protein (CETP']","['adjusted changes of apoB, apoB: apoA-1, insulin, HOMA-IR and QUICKI', 'diastolic blood pressure, and LDL: HDL, TC: HDL and TG: HDL ratios', 'diastolic blood pressure, apoB and apoB: apoA-1,and higher Lp(a', 'metabolic response', 'Blood samples']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C1144465', 'cui_str': 'CETP protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003592', 'cui_str': 'Apolipoprotein A'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",95.0,0.0273185,"A significant genotype-dietary oils combined effects were observed for diastolic blood pressure, and LDL: HDL, TC: HDL and TG: HDL ratios in diabetes patients.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Ramezani-Jolfaie', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Aghaei', 'Affiliation': 'Stem Cell Biology Research Center, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Farashahi Yazd', 'Affiliation': 'Stem Cell Biology Research Center, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Moradi', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Raeisi-Dehkordi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghtaderi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zimorovat', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Yasini Ardakani', 'Affiliation': 'Department of Food Science and Technology, Islamic Azad University, Yazd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Journal of cardiovascular and thoracic research,['10.34172/jcvtr.2020.32']
2187,33123327,Pregnancy outcome in women with mechanical prosthetic heart valvesat their first trimester of pregnancy treated with unfractionated heparin (UFH) or enoxaparin: A randomized clinical trial.,"Introduction:  Pregnancy increases the risks of thromboembolism for the mother and fetus in patients with mechanical heart valves. The results of some studies have indicated that low molecular weight heparin (LMWH), in comparison with unfractionated heparin (UFH), leads to a lower incidence rate of thrombocytopenia and a decrease in bleeding.  Methods:  The present randomized clinical trial involved 31 pregnant women with mechanical heart valves at their first trimester (0-14 weeks) of pregnancy. To perform the study, the patients were divided into two groups, i.e. group A (LMWH group-16 patients) and group B (UFH group-15 patients). The birth weight, mode of delivery, and gestational age at birth as well as the maternal and fetal complications were compared between the two groups.  Results:  The mean age of mothers in the UFH and LMWH groups was 32.67±9.11 and 31.50±5.81years, respectively ( P  value > 0.05). Although the rate of maternal and fetal complications was higher in the UFH group as compared with the LMWH group, the observed difference was not significant ( P  value > 0.05).  Conclusion:  LMWH can be regarded as a safer therapy for both the mother and fetus due to its lower number of refill prescriptions and fewer changes in the blood level.",2020,"Although the rate of maternal and fetal complications was higher in the UFH group as compared with the LMWH group, the observed difference was not significant ( P  value > 0.05).  ","['women with mechanical prosthetic heart valvesat their first trimester of pregnancy treated with', '31 pregnant women with mechanical heart valves at their first trimester (0-14 weeks) of pregnancy', 'patients with mechanical heart valves']","['UFH', 'LMWH', 'enoxaparin', 'unfractionated heparin (UFH']","['birth weight, mode of delivery, and gestational age at birth as well as the maternal and fetal complications', 'bleeding', 'rate of maternal and fetal complications', 'risks of thromboembolism']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0851390', 'cui_str': 'Foetal complications'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",31.0,0.0341811,"Although the rate of maternal and fetal complications was higher in the UFH group as compared with the LMWH group, the observed difference was not significant ( P  value > 0.05).  ","[{'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Movahedi', 'Affiliation': 'Department of Obstetrics and Gynecology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Motamedi', 'Affiliation': 'Department of Obstetrics and Gynecology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Sajjadieh', 'Affiliation': 'Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Bahrami', 'Affiliation': 'Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Cardiac Surgery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of General Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of cardiovascular and thoracic research,['10.34172/jcvtr.2020.35']
2188,33127467,The Randomized Controlled ATLANTIS Trial of Aquatic Therapy for Chronic Venous Insufficiency.,"OBJECTIVE


There are conflicting reports on the efficacy of exercise in chronic venous insufficiency (CVI). Exercise in water or aquatic activity (AA) can have additional advantages. We sought to evaluate the clinical effects of AA in CVI in a randomized prospective open label fashion.
METHODS


A total of 201 patients with advanced CVI were randomized to receive AA vs. no such treatment. In the Aquatic Group (AG) 91 patients reached the 24- month follow-up point and in the Control Group (CG) 90 patients did. The primary efficacy endpoint was a pre-defined reduction of ˃4 points in the VCSS at 3months. Instruments of venous disease severity and quality of life were compared at baseline, 3months and 24months between and within the 2 groups. These included the modified Venous Clinical Severity Score (VCSS), Villalta score, leg and thigh circumference, the Physical Health Component of SF36 (SF36-PHC), and the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptom (VEINES- QOL and VEINES-Sym) scores. Aquatic activity consisted of a minimum of 15 minutes of walking in a swimming pool at 1m/s, 3 times/week for 3 months.
RESULTS


The primary endpoint of 4 point reduction in the modified VCSS at 3 months was reached in 28% of AG and 3% of CG (OR= 12.08; 95% CI: 3.51, 41.59; p<0.001). Comparison of changes in secondary endpoints from baseline to 24 months between AG and CG demonstrated the following: VCSS -4.08±2.08 vs. -1.15±1.26, Villalta score -4.00±2.68 vs. -1.01±1.34, thigh circumference -3.40±1.78 cm vs. -1.40±2.55cm, leg circumference -1.27±1.34 cm vs. -0.49 ±1.21cm, SF36-PHC 3.82±2.36 vs. 1.16±1.18, VEINES-QOL 3.35±1.67 vs. 1.30±1.43, and VEINES- Sym 3.53±1.71 vs. 1.23±1.26, (p<0.001 for all comparisons; ± denotes mean ±SD).
CONCLUSIONS


Addition of AA to the treatment of patients with advanced CVI is safe and effective leading to significant improvement in clinical status and quality of life. These beneficial changes occur rapidly within 3 months of initiation of AA and are continued at a slower rate of improvement from 3 months to 2 years.",2020,"Comparison of changes in secondary endpoints from baseline to 24 months between AG and CG demonstrated the following: VCSS -4.08±2.08 vs. -1.15±1.26, Villalta score -4.00±2.68 vs. -1.01±1.34, thigh circumference -3.40±1.78 cm vs. -1.40±2.55cm, leg circumference -1.27±1.34 cm vs. -0.49 ±1.21cm, SF36-PHC 3.82±2.36 vs. 1.16±1.18, VEINES-QOL 3.35±1.67 vs. 1.30±1.43, and VEINES- Sym 3.53±1.71 vs. 1.23±1.26, (p<0.001 for all comparisons; ± denotes mean ±SD).
","['Chronic Venous Insufficiency', '201 patients with advanced CVI', 'chronic venous insufficiency (CVI']","['Aquatic Therapy', 'Exercise in water or aquatic activity (AA']","['modified VCSS', 'venous disease severity and quality of life', 'clinical status and quality of life', 'modified Venous Clinical Severity Score (VCSS), Villalta score, leg and thigh circumference, the Physical Health Component of SF36 (SF36-PHC), and the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptom (VEINES- QOL and VEINES-Sym) scores']","[{'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",201.0,0.0515279,"Comparison of changes in secondary endpoints from baseline to 24 months between AG and CG demonstrated the following: VCSS -4.08±2.08 vs. -1.15±1.26, Villalta score -4.00±2.68 vs. -1.01±1.34, thigh circumference -3.40±1.78 cm vs. -1.40±2.55cm, leg circumference -1.27±1.34 cm vs. -0.49 ±1.21cm, SF36-PHC 3.82±2.36 vs. 1.16±1.18, VEINES-QOL 3.35±1.67 vs. 1.30±1.43, and VEINES- Sym 3.53±1.71 vs. 1.23±1.26, (p<0.001 for all comparisons; ± denotes mean ±SD).
","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Arizona Cardiovascular Consultants & Vein Clinic, Mesa, Arizona; A.T.Still University, Mesa, Arizona. Electronic address: seyedmohsensharifi@yahoo.com.'}, {'ForeName': 'Curt', 'Initials': 'C', 'LastName': 'Bay', 'Affiliation': 'A.T.Still University, Mesa, Arizona.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Karandish', 'Affiliation': 'Arizona Cardiovascular Consultants & Vein Clinic, Mesa, Arizona.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Emrani', 'Affiliation': 'Arizona Cardiovascular Consultants & Vein Clinic, Mesa, Arizona.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': 'Arizona Cardiovascular Consultants & Vein Clinic, Mesa, Arizona.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': ""D'Silva"", 'Affiliation': 'Arizona Cardiovascular Consultants & Vein Clinic, Mesa, Arizona.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.10.016']
2189,33127493,The risk of subclinical breast cancer-related lymphedema by the extent of axillary surgery and regional node irradiation-a randomized controlled trial.,"PURPOSE


To compare the risk of subclinical breast cancer-related lymphedema (sBCRL) using Bioimpedance Spectroscopy (BIS) or Tape-Measure (TM) by the extent of axillary surgery and regional nodal irradiation (RNI).
PATIENTS AND METHODS


Patients were randomized to surveillance with TM or BIS. A BIS ≥ 6.5 L-Dex units or TM volume change ≥ 5 and <10% above pre-surgical baselines ""triggered"" sBCRL. The incidence of sBCRL by sentinel node biopsy (SNB) or axillary lymph node dissection (ALND) +/- RNI was examined for 484 patients. Radiation was categorized as ""Limited RNI"": Axilla Level I/II only or ""Extensive RNI"": Axilla Level III and/or supraclavicular fossa (SCF) +/- Level I/II.
RESULTS


At a median follow-up of 20.5 months, 109 of 498 patients (21.9%) triggered (BIS 13.5% vs TM 25.6%, p<0.001). In patients not receiving RNI, BIS triggered 12.9% of patients undergoing SNB and 25.0% undergoing ALND (p=0.18). Extensive RNI significantly increased triggering with BIS versus no RNI after SNB (33.3% vs 12.9%, p=0.03) but not ALND (30.8% vs 25.0%, p=0.69). Triggering by TM was over 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
CONCLUSION


The lower triggering rates with BIS and its better discrimination of the risk of sBCRL by receipt and type of RNI as compared to TM support its use for post-treatment surveillance to detect sBCRL and initiate early intervention. The risk of sBCRL increased with more extensive axillary treatment. Patients having ALND or extensive RNI require close surveillance for BCRL. Longer follow-up is required to determine rates of progression to clinical lymphedema.",2020,"Triggering by TM was over 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
","['Patients having ALND or extensive RNI require close surveillance for BCRL', '484 patients', 'Patients were randomized to surveillance with']","['TM or BIS', 'Bioimpedance Spectroscopy (BIS) or Tape-Measure (TM) by the extent of axillary surgery and regional nodal irradiation (RNI']","['incidence of sBCRL by sentinel node biopsy (SNB) or axillary lymph node dissection (ALND) ', 'risk of sBCRL', 'risk of subclinical breast cancer-related lymphedema (sBCRL']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0851211,"Triggering by TM was over 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boyages', 'Affiliation': 'Australian Lymphedema Education, Research and Treatment program, Macquarie University, Sydney, Australia; Icon Cancer Centre, NSW Australia. Electronic address: john.boyages@icon.team.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Vicini', 'Affiliation': 'Michigan Healthcare Professionals, 21St Century Oncology, Farmington Hills, MI.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Cleveland Clinic, Taussig Cancer Institute, Department of Radiation Oncology, Cleveland, OH.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Koelmeyer', 'Affiliation': 'Australian Lymphedema Education, Research and Treatment program, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jerrod A', 'Initials': 'JA', 'LastName': 'Nelms', 'Affiliation': 'TTi Health Research and Economics, 123 Tech Court #201, Westminster, MD 21157. Electronic address: jnelms@transtechint.com.'}, {'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.10.024']
2190,33127531,"Association between levosimendan, postoperative AKI, and mortality in cardiac surgery: Insights from the LEVO-CTS trial.","OBJECTIVES


We aimed to evaluate the association between levosimendan treatment and acute kidney injury (AKI) as well as assess the clinical sequelae of AKI in cardiac surgery patients with depressed LV function (ejection fraction < 35%).
METHODS


Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery were stratified by occurrence and severity of post-operative AKI using the AKIN classification. The association between levosimendan infusion and AKI was modeled using multivariable regression.
RESULTS


Among 854 LEVO-CTS patients, 231 (27.0%) experienced postoperative AKI, including 182 (21.3%) with stage 1, 35 (4.1%) with stage 2, and 14 (1.6%) with stage 3 AKI. The rate of AKI was similar between patients receiving levosimendan or placebo. The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% CI 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4). No association was observed between levosimendan, AKI stage, and odds of 30-day mortality (interaction p=0.69). Factors independently associated with AKI included increasing age, BMI, diabetes, and increasing baseline systolic blood pressure. Increasing baseline eGFR and aldosterone antagonist use were associated with a lower risk of AKI.
CONCLUSIONS


Postoperative AKI is common among high-risk patients undergoing cardiac surgery and associated with significantly increased risk of 30-day death or dialysis. Levosimendan was not associated with the risk of AKI.",2020,"The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% CI 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4).","['cardiac surgery', 'cardiac surgery patients with depressed LV function (ejection fraction < 35', 'Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery']","['levosimendan or placebo', 'levosimendan', 'Levosimendan']","['baseline systolic blood pressure', 'risk of AKI', 'rate of AKI', 'risk of 30-day death or dialysis', '30-day mortality', 'levosimendan, AKI stage, and odds of 30-day mortality', 'postoperative AKI']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.202536,"The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% CI 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4).","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Raman', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Department of Critical Care and Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'Department of Anesthesia, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Meyer', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stafford-Smith', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}]",American heart journal,['10.1016/j.ahj.2020.10.066']
2191,33127554,Platelet Rich Plasma in Patients with Partial Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared to Corticosteroid Injection: A Double-blind Randomized Controlled Trial.,"PURPOS: e: The purpose of this study was to perform a randomized controlled trial, comparing platelet-rich plasma (PRP) to standard corticosteroid (CS) in providing pain relief and improved function in patients with rotator cuff tendinopathy and partial thickness rotator cuff tears (PTRCT).
METHODS


This double-blind randomized-controlled trial enrolled patients with ultrasound or MRI proven PTRCT to either an ultrasound-guided PRP or CS injection. Patients completed patient reported outcomes at baseline, 6 weeks, 3 and 12 months post-injection. The primary outcome was improvement in visual analog scale for pain (VAS). Secondary outcomes included change in American Shoulder Elbow Surgeons (ASES) and Western Ontario Rotator Cuff index (WORC) scores. Failure of treatment was defined by subsequent injection, consent to surgery or operative intervention.
RESULTS


99 patients (47 in the PRP and 52 in the CS groups) were followed to 12 months post-injection. There were no differences in baseline patient demographics including age, sex or duration of symptoms. Despite randomization, patients in the PRP group had worse baseline VAS (46.0 vs. 34.7, p=0.01), ASES (53.9 vs. 61.8, p=0.02) and WORC (42.2 vs. 49.5, p=0.03) scores. At 3 months post-injection, the PRP group had superior improvement in VAS (-13.6 vs. 0.4, p=0.03), ASES (13.0 vs. 2.9, p=0.02) and WORC (16.8 vs. 5.8, p=0.03) scores. There were no differences in patient reported outcomes at 6 weeks or 12 months. There was no difference in failure rates (p=0.31) or conversion to surgery (p=0.83) between groups.
CONCLUSIONS


Patients with PTRCTs or tendinopathy experienced clinical improvement in pain and patient-reported outcome scores after both ultrasound-guided CS and PRP injections. Patients who received PRP obtained superior improvement in pain and function at short-term follow up (3 months). There was no sustained benefit of PRP over CS at longer-term follow-up (12 months).
LEVEL OF EVIDENCE


Level 1, Randomized controlled trial.",2020,"There was no difference in failure rates (p=0.31) or conversion to surgery (p=0.83) between groups.
","['enrolled patients with ultrasound or MRI proven PTRCT to either an', '99 patients (47 in the PRP and 52 in the CS groups', 'Patients with Partial Thickness Rotator Cuff Tears or Tendinopathy', 'patients with rotator cuff tendinopathy and partial thickness rotator cuff tears (PTRCT']","['Corticosteroid Injection', 'PRP', 'ultrasound-guided PRP or CS injection', 'PURPOS', 'platelet-rich plasma (PRP) to standard corticosteroid (CS']","['change in American Shoulder Elbow Surgeons (ASES) and Western Ontario Rotator Cuff index (WORC) scores', 'ASES', 'visual analog scale for pain (VAS', 'VAS', 'pain and function', 'baseline VAS', 'Short-Term Pain Relief and Function', 'failure rates', 'baseline patient demographics including age, sex or duration of symptoms', 'WORC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0410018', 'cui_str': 'Partial thickness rotator cuff tear'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",99.0,0.477039,"There was no difference in failure rates (p=0.31) or conversion to surgery (p=0.83) between groups.
","[{'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Kwong', 'Affiliation': 'Department of Surgery, Section of Orthopedic Surgery, University of Calgary, Calgary, Alberta, Canada. Electronic address: cakwong87@gmail.com.'}, {'ForeName': 'Jarret M', 'Initials': 'JM', 'LastName': 'Woodmass', 'Affiliation': 'Pan Am Clinic, Department of Orthopedics, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Gusnowski', 'Affiliation': 'Department of Surgery, Section of Orthopedic Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Bois', 'Affiliation': 'Department of Surgery, Section of Orthopedic Surgery, McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Leblanc', 'Affiliation': 'Department of Surgery, Section of Orthopedic Surgery, McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kristie D', 'Initials': 'KD', 'LastName': 'More', 'Affiliation': 'University of Calgary Sport Medicine Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Ian K Y', 'Initials': 'IKY', 'LastName': 'Lo', 'Affiliation': 'Department of Surgery, Section of Orthopedic Surgery, McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Alberta, Canada.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.10.037']
2192,33127596,Efficacy and Safety of Extended Induction with Tofacitinib for the Treatment of Ulcerative Colitis.,"BACKGROUND & AIMS


Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in a dose-ranging phase 2 induction trial, three phase 3 randomized, placebo-controlled trials (OCTAVE Induction 1 and 2; and OCTAVE Sustain), and an ongoing, open-label, long-term extension trial (OCTAVE Open) in patients with moderately to severely active UC. Here, we assessed short- and long-term efficacy and safety of extended induction (16 weeks) with tofacitinib 10 mg twice daily (BID) in patients who failed to respond to initial induction (8 weeks) treatment.
METHODS


In patients who achieved a clinical response following extended induction (delayed responders), the efficacy and safety of tofacitinib were evaluated up to Month 36 of OCTAVE Open.
RESULTS


52.2% of patients who did not achieve clinical response to 8 weeks' treatment with tofacitinib 10 mg BID in the induction studies achieved a clinical response following extended induction (delayed responders). At Month 12 of OCTAVE Open, 70.3%, 56.8%, and 44.6% of delayed responders maintained clinical response and achieved endoscopic improvement and remission, respectively. Corresponding values at Month 36 were 56.1%, 52.0%, and 44.6%. The safety profile of the subsequent 8 weeks was similar to the initial 8 weeks.
CONCLUSIONS


Overall, the majority of patients achieved a clinical response after 8 or 16 weeks' induction therapy with tofacitinib 10 mg BID. Tofacitinib 10 mg BID, administered as induction therapy for up to 16 weeks, had a comparable safety profile to 8 weeks' induction therapy. Most delayed responders at Month 36 were in remission.",2020,"Tofacitinib 10 mg BID, administered as induction therapy for up to 16 weeks, had a comparable safety profile to 8 weeks' induction therapy.","['Ulcerative Colitis', 'patients who failed to respond to initial induction (8 weeks) treatment', 'patients with moderately to severely active UC']","['placebo', 'tofacitinib', 'Tofacitinib']","['delayed responders maintained clinical response and achieved endoscopic improvement and remission', 'efficacy and safety', 'clinical response', 'efficacy and safety of tofacitinib', 'Efficacy and Safety']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}]",,0.193431,"Tofacitinib 10 mg BID, administered as induction therapy for up to 16 weeks, had a comparable safety profile to 8 weeks' induction therapy.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Inserm U1256 and Department of Gastroenterology, Nancy University Hospital, Lorraine University, Vandœuvre lès-Nancy, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Quirk', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Chudy I', 'Initials': 'CI', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: bruce.sands@mssm.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.10.038']
2193,33127637,Proactive telephone-based peer support for breastfeeding: a cross-sectional survey of women's experiences of receiving support in the RUBY randomised controlled trial.,"OBJECTIVE


The Ringing Up about Breastfeeding earlY (RUBY) randomised controlled trial (RCT) of proactive telephone-based peer support for breastfeeding found that infants of women allocated to the intervention were more likely to be receiving breast milk at 6 months of age than those receiving usual care. This study explores women's experiences of receiving the RUBY peer support intervention.
DESIGN


Cross-sectional survey.
SETTING


Women were recruited from the postnatal units of three tertiary hospitals in Melbourne, Australia.
PARTICIPANTS


Women allocated to receive telephone peer support in the RUBY RCT who completed a telephone interview at 6 months postpartum (501/574 (87%) in trial intervention arm) were invited to complete a postal survey on their experience of receiving support.
OUTCOMES


Experiences of support from the allocated peer, perceived helpfulness, topics discussed, overall satisfaction with the support and frequency and duration of contact were explored.
RESULTS


Surveys were sent between August 2013 and March 2016, and 72% (360/501) responded of whom 341 recalled receiving peer support. Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%). Discussions included breastfeeding topics (milk supply, attachment), baby care, baby behaviour, and reassurance and emotional support. Women valued the practical and realistic support from another mother, as well as the proactive nature, continuity and accessibility of the support. The empathy, reassurance and encouragement provided helped the mothers to 'cope', to continue breast feeding and to feel empowered.
CONCLUSION


Most respondents were positive about their experience of receiving proactive telephone peer support for breastfeeding, further supporting the roll-out of this model as a strategy for increasing breastfeeding maintenance to 6 months. Recommendations include flexibility in the scheduling of calls according to individual need, and the use of text messages in conjunction with proactive calls, to enhance and facilitate communication between the peer and the mother.
TRIAL REGISTRATION NUMBER


ACTRN12612001024831.",2020,Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%).,"['Surveys were sent between August 2013 and March 2016, and 72% (360/501) responded of whom 341 recalled receiving peer support', 'Women were recruited from the postnatal units of three tertiary hospitals in Melbourne, Australia', 'Women allocated to receive']","['proactive telephone-based peer support', 'Proactive telephone-based peer support for breastfeeding', 'telephone peer support in the RUBY RCT who completed a telephone interview']","['breastfeeding topics (milk supply, attachment), baby care, baby behaviour, and reassurance and emotional support', 'overall satisfaction', 'perceived helpfulness, topics discussed, overall satisfaction with the support and frequency and duration of contact']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0696554,Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%).,"[{'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'McLardie-Hore', 'Affiliation': ""Midwifery and Maternity Services Research, Royal Women's Hospital, Parkville, Victoria, Australia Fiona.McLardieHore@thewomens.org.au.""}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Touran', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Della A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': ""Midwifery and Maternity Services Research, Royal Women's Hospital, Parkville, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2020-040412']
2194,33127945,Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study.,"The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.",2020,"Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients.","['breast cancer patients postoperatively treated with two regimens of', 'Altogether 117 breast cancer patients who had axillary lymphadenectomy', 'breast cancer patients']","['tramadol', 'tramadol with paracetamol', 'tramadol with paracetamol, while weaker analgesia group received every 8\xa0h 37.5/325\xa0mg of tramadol with paracetamol']","['Frequency of nausea, vomiting, lymphedema or range of shoulder movement', 'Constipation', 'Acute pain and side effects', 'acute pain and side effects', 'pain']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",117.0,0.221722,"Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients.","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Besic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia. nbesic@onko-i.si.'}, {'ForeName': 'Jaka', 'Initials': 'J', 'LastName': 'Smrekar', 'Affiliation': 'Faculty of Mathematics and Physics, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Strazisar', 'Affiliation': 'Department of Anesthesiology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia.'}]",Scientific reports,['10.1038/s41598-020-75961-2']
2195,33127947,Changes in peripheral immune populations during pregnancy and modulation by probiotics and ω-3 fatty acids.,"Allergic diseases have become a major health problem, partly due to reduced microbial stimulation and a decreased dietary ω-3/ω-6 long-chain polyunsaturated fatty acid ratio. Prenatal exposures have been reported to influence allergy development, possibly induced via changes in maternal immune regulation. In a randomized double-blind placebo-controlled multicenter allergy prevention trial (PROOM-3), pregnant women were recruited at gestational week 20, and randomized to four study groups, one receiving both L. reuteri oil drops and ω-3 PUFA capsules (n = 22), the second receiving ω-3 PUFA supplementation and placebo regarding L. reuteri (n = 21), the third receiving L. reuteri and placebo regarding ω-3 PUFA (n = 22) and the fourth group receiving placebo capsules and placebo oil drops (n = 23). In this substudy, supplemental and pregnancy-related effects on maternal peripheral immune cell populations during pregnancy were assessed by flow cytometry immune phenotyping at gestational week 20, 32 and 4 days after delivery. The numbers of activated and regulatory T (Treg) cells (CD45RA -  Foxp3 ++ /CD45RA + Foxp3 + ) were reduced after delivery, with the lowest count in the L. reuteri supplemented group compared with the placebo group 4 days after delivery, while the ω-3 PUFA group did not differ from the placebo group. Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/-  monocytes, and in subpopulations of T helper cells (Th) CD4 + CD45RA - Tbet +  (Th1) and CD4 + CD45RA - RORC +  (Th17) cells. In conclusion, probiotic supplementation to the mother during the second half of pregnancy resulted in immunomodulatory effects among activated and resting Treg cells. Furthermore, several systemic immune modifying effects of pregnancy were observed.",2020,"Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/-  ",['pregnant women were recruited at gestational week 20'],"['CD14 + 16 ', 'probiotic supplementation', 'placebo', 'L. reuteri oil drops and ω-3 PUFA capsules', 'placebo capsules and placebo oil drops', 'ω-3 PUFA supplementation and placebo']","['monocytes, and in subpopulations of T helper cells (Th) CD4 + CD45RA - Tbet +  (Th1) and CD4 + CD45RA - RORC +  (Th17) cells', 'numbers of activated and regulatory T (Treg) cells (CD45RA -  Foxp3 ++ /CD45RA + Foxp3 + ']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C2724208', 'cui_str': '++'}]",,0.341412,"Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/-  ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Division of Neuro and Inflammation Sciences, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. annfo663@gmail.com.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Paediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Allergy Centre, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Duchén', 'Affiliation': 'Department of Paediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Division of Neuro and Inflammation Sciences, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-75312-1']
2196,33122881,"Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis.","Purpose


The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis.
Subjects and Methods


A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria.
Results


The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05).
Conclusion


While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle.",2020,"The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics.","['Subjects and Methods\n\n\nA total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses']","['polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens']","['overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C2002496', 'cui_str': 'balafilcon A'}]","[{'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023693', 'cui_str': 'Light'}]",669.0,0.0455178,"The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Reindel', 'Affiliation': 'Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mosehauer', 'Affiliation': 'Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Rah', 'Affiliation': 'Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin & Associates, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steffen', 'Affiliation': 'Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S268286']
2197,33123023,No Decrease in Blood Pressure After an Acute Bout of Intermittent Hyperpnea and Hypoxia in Prehypertensive Elderly.,"Prevalence of hypertension, subjective sleep complaints and snoring increases with age. Worse sleep and snoring, in turn, are independent risk factors to develop hypertension. Both respiratory muscle training (RMT) and intermittent hypoxia (IH) are suggested to have positive effects on these physiological and behavioral variables. This study therefore aimed to test the acute effects of a single bout of RMT, with and without IH, on resting blood pressure (BP) and sleep. Fourteen prehypertensive elderly performed a 60-min session of (a) intermittent voluntary normocapnic hyperpnea (HYP) alone, (b) HYP in combination with IH (HYP&IH) and (c) a sham intervention in randomized order. BP, hemodynamics, heart rate variability (HRV), cardiac baroreflex sensitivity (BRS) and pulse wave velocity (PWV) were assessed before and 15, 30 and 45 min after each intervention. Variables of sleep were assessed with actigraphy, pulse oximetry and with questionnaires during and after the night following each intervention. Neither HYP nor HYP&IH resulted in a decrease in BP. Repeated measures ANOVA revealed no significant interaction effect for systolic BP ( p  = 0.090), diastolic BP ( p  = 0.151), HRV parameters, BRS and PWV (all  p  > 0.095). Fragmentation index was lower after both HYP (-6.5 units) and HYP&IH (-8.4 units) compared to sham,  p (ANOVA) = 0.046, although pairwise comparisons reveal no significant differences. There were no other significant effects for the remaining sleep variables. We conclude that one bout of intermittent hyperpnea, alone or in combination with IH, is not effective in lowering blood pressure or improving sleep in prehypertensive elderly.",2020,"Fragmentation index was lower after both HYP (-6.5 units) and HYP&IH (-8.4 units) compared to sham,  p (ANOVA) = 0.046, although pairwise comparisons reveal no significant differences.","['Prehypertensive Elderly', 'prehypertensive elderly', 'Fourteen prehypertensive elderly']","['RMT, with and without IH', '60-min session of (a) intermittent voluntary normocapnic hyperpnea (HYP) alone, (b) HYP in combination with IH (HYP&IH) and (c) a sham intervention', 'respiratory muscle training (RMT) and intermittent hypoxia (IH']","['Prevalence of hypertension, subjective sleep complaints and snoring increases with age', 'systolic BP', 'BP, hemodynamics, heart rate variability (HRV), cardiac baroreflex sensitivity (BRS) and pulse wave velocity (PWV', 'blood pressure', 'HRV parameters, BRS and PWV', 'Blood Pressure', 'Worse sleep and snoring', 'Fragmentation index', 'resting blood pressure (BP) and sleep', 'diastolic BP', 'BP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",14.0,0.0528376,"Fragmentation index was lower after both HYP (-6.5 units) and HYP&IH (-8.4 units) compared to sham,  p (ANOVA) = 0.046, although pairwise comparisons reveal no significant differences.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stutz', 'Affiliation': 'Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Oliveras', 'Affiliation': 'Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Eiholzer', 'Affiliation': 'Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Spengler', 'Affiliation': 'Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zürich, Zurich, Switzerland.'}]",Frontiers in physiology,['10.3389/fphys.2020.556220']
2198,33123046,The Profiles of Body Image Associate With Changes in Depression Among Participants in Dance Movement Therapy Group.,"This mixed-methods study analyzed the body image quality of 143 patients with depression. The participants received a 20 × 75 min dance movement therapy (DMT) group treatment, sessions twice a week. Body Image Assessment (BIA) was the data collection tool, with pre-, post-, and 3-mos follow-up assessments. Pre-intervention body image quality characteristics were low energy and activity levels, discomfort, shame and disgust toward the body, tension in social interactions. On the BIA scores, a statistical method of Latent Profile Analysis was utilized to identify participant profiles in the data. The two identified profiles were participant with initial negative body image and participant with initial neutral body image. Depression symptoms were measured with BDI, and symptoms decreased for both participant profiles following the DMT intervention. The neutral profile participants had a significantly lower depression level, better energy level, and more frequently used mindfulness factors of acting aware, non-judgmentality and non-reactivity (measured with FFMQ). Findings suggest a systemic interaction between depression symptoms, body image, attachment style, activity level, and mindfulness skills. In an interactive DMT setting it is possible to address all of these factors simultaneously.",2020,"The neutral profile participants had a significantly lower depression level, better energy level, and more frequently used mindfulness factors of acting aware, non-judgmentality and non-reactivity (measured with FFMQ).",['143 patients with depression'],['20 × 75 min dance movement therapy (DMT'],"['low energy and activity levels, discomfort, shame and disgust toward the body, tension in social interactions', 'BDI, and symptoms', 'depression symptoms, body image, attachment style, activity level, and mindfulness skills', 'Body Image Assessment (BIA', 'depression level, better energy level', 'Depression symptoms']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",143.0,0.0198532,"The neutral profile participants had a significantly lower depression level, better energy level, and more frequently used mindfulness factors of acting aware, non-judgmentality and non-reactivity (measured with FFMQ).","[{'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Pylvänäinen', 'Affiliation': 'Tampere Psychiatric Unit, Tampere City Mental Health Services, Tampere, Finland.'}, {'ForeName': 'Katriina', 'Initials': 'K', 'LastName': 'Hyvönen', 'Affiliation': 'Faculty of Social Sciences/Psychology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Joona', 'Initials': 'J', 'LastName': 'Muotka', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.564788']
2199,33123089,Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.,"Introduction


Type 2 diabetes (T2DM) is a major health concern with significant personal and healthcare system costs. There is growing interest in using shared medical appointments (SMAs) for management of T2DM. We hypothesize that adding mindfulness to SMAs may be beneficial. This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia.
Materials and Methods


We conducted a single-blind randomized controlled feasibility study of SMAs within primary care for people with T2DM living in Western Sydney, Australia. People with T2DM, age 21 years and over, with HbA1c > 6.5% or fasting glucose >7.00 mmol/L within the past 3 months were eligible to enroll. The intervention group attended six 2-h programmed SMAs (pSMAs) which were held fortnightly. pSMAs included a structured education program and mindfulness component. The control group received usual care from their healthcare providers. We collected quantitative and qualitative data on acceptability as well as glycemic control (glycated hemoglobin and continuous glucose monitoring), lipids, anthropometric measures, blood pressure, self-reported psychological outcomes, quality of life, diet, and physical activity using an ActiGraph accelerometer.
Results


Over a 2-month period, we enrolled 18 participants (10 females, 8 males) with a mean age of 58 years (standard deviation 9.8). We had 94.4% retention. All participants in the intervention group completed at least four pSMAs. Participants reported that attending pSMAs had been a positive experience that allowed them to accept their diagnosis and empowered them to make changes, which led to beneficial effects including weight loss and better glycemic control. Four pSMA participants found the mindfulness component helpful while two did not. All of the seven participants who contributed to qualitative evaluation reported improved psychosocial wellbeing and found the group setting beneficial. There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group;  p  = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38;  p  = 0.034).
Conclusion


pSMAs are feasible and acceptable to people with T2DM and may result in clinical improvement. A follow-up fully-powered randomized controlled trial is warranted.
Clinical Trial Registration


Australia and New Zealand Clinical Trial Registry, identifier ACTRN12619000892112.",2020,"There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group;  p  = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38;  p  = 0.034).
","['People with T2DM, age 21 years and over, with HbA1c > 6.5% or fasting', 'people with T2DM living in Western Sydney, Australia', 'within primary care in Australia', '18 participants (10 females, 8 males) with a mean age of 58 years (standard deviation 9.8']","['intervention group attended six 2-h programmed SMAs (pSMAs', 'SMAs', 'usual care from their healthcare providers', 'SMAs with mindfulness for T2DM']","['glycemic control (glycated hemoglobin and continuous glucose monitoring), lipids, anthropometric measures, blood pressure, self-reported psychological outcomes, quality of life, diet, and physical activity using an ActiGraph accelerometer', 'pain intensity levels', 'weight loss and better glycemic control', 'total cholesterol levels', 'psychosocial wellbeing']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C5197873', 'cui_str': 'Shared Medical Appointments'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",18.0,0.0953523,"There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group;  p  = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38;  p  = 0.034).
","[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Ee', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'de Courten', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Avard', 'Affiliation': 'Next Practice Health, Erina, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'de Manincor', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Al-Dabbas', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'McBride', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Shamieka', 'Initials': 'S', 'LastName': 'Dubois', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Rhiannon Lee', 'Initials': 'RL', 'LastName': 'White', 'Affiliation': 'School of Health Sciences, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Catharine', 'Initials': 'C', 'LastName': 'Fleming', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Egger', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore, NSW, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Blair', 'Affiliation': 'Diabetes NSW and ACT, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore, NSW, Australia.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'MacMillan', 'Affiliation': 'Translational Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Deed', 'Affiliation': 'Mediwell Clinic, Brisbane, QLD, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Templeman', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Chang', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.570777']
2200,33123091,Iodine Supplementation in Mildly Iodine-Deficient Pregnant Women Does Not Improve Maternal Thyroid Function or Child Development: A Secondary Analysis of a Randomized Controlled Trial.,"Background:  Iodine deficiency during pregnancy may be associated with lower offspring IQ, but there are few data on the safety and efficacy of maternal iodine supplementation on child development. In a previously reported multi-center randomized trial conducted in Thailand and India, we assessed the effect of iodine supplementation in mildly iodine-deficient pregnant women on offspring development. In this secondary analysis of that trial, we report data only from the Thai pregnant women in the study, who were more iodine deficient at entry.  Methods:  Pregnant women in Bangkok, Thailand, were randomized to receive daily 200 μg oral iodine or placebo until delivery. We assessed thyroid size and thyroid function during pregnancy and cognitive and motor development at ages 1, 2, and 5.7 years. The trial was registered at www.clinicaltrials.gov/NCT00791466.  Findings:  Women ( n  = 514) entered the trial between November 2008 and March 2011 at a mean ± SD gestational age of 11 ± 2.8 weeks; their median (IQR) UIC was 112 (75, 170) μg/L. Mean compliance with supplementation was 88%. We assessed 397 mothers in the 3rd trimester, 231 infants at age 2 y, and 157 children at mean age 5.7 y. During pregnancy, there was a slightly greater decrease in free and total thyroxine concentrations in the iodine group ( p  < 0.05). At age 2 years, the iodine group had borderline lower scores for combined fine and gross motor function ( p  = 0.05), but there were no other significant differences in development. At 5.7 years, there were no significant group differences in child development.  Conclusion:  Daily iodine supplementation in mildly iodine deficient pregnant women was associated with small negative effects on maternal thyroxine concentrations, but did not affect child development. The safety and efficacy of iodine supplementation in mildly-iodine deficient pregnant women needs to be evaluated further in large randomized controlled trials.",2020,"At age 2 years, the iodine group had borderline lower scores for combined fine and gross motor function ( p  = 0.05), but there were no other significant differences in development.","['Pregnant women in Bangkok, Thailand', 'Mildly Iodine-Deficient Pregnant Women', 'Findings:  Women ( n  = 514) entered the trial between November 2008 and March 2011 at a mean ± SD gestational age of 11 ± 2.8 weeks; their median (IQR) UIC was 112 (75, 170', 'Thai pregnant women in the study, who were more iodine deficient at entry', 'mildly iodine deficient pregnant women', 'mildly-iodine deficient pregnant women', 'mildly iodine-deficient pregnant women on offspring development', '397 mothers in the 3rd trimester, 231 infants at age 2 y, and 157 children at mean age 5.7 y']","['daily 200 μg oral iodine or placebo', 'iodine supplementation', 'maternal iodine supplementation', 'Iodine Supplementation', 'Daily iodine supplementation']","['free and total thyroxine concentrations', 'thyroid size and thyroid function', 'safety and efficacy', 'Maternal Thyroid Function or Child Development', 'child development', 'maternal thyroxine concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517795', 'cui_str': '5.7'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}]",,0.302995,"At age 2 years, the iodine group had borderline lower scores for combined fine and gross motor function ( p  = 0.05), but there were no other significant differences in development.","[{'ForeName': 'Nicole J E', 'Initials': 'NJE', 'LastName': 'Verhagen', 'Affiliation': 'Division of Human Nutrition, Wageningen University and Research, Wageningen, Netherlands.'}, {'ForeName': 'Sueppong', 'Initials': 'S', 'LastName': 'Gowachirapant', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Pattanee', 'Initials': 'P', 'LastName': 'Winichagoon', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': ""Division of Gastroenterology and Nutrition, Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Melse-Boonstra', 'Affiliation': 'Division of Human Nutrition, Wageningen University and Research, Wageningen, Netherlands.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.572984']
2201,33123474,Clinical Application of Oral Meglumine Diatrizoate Esophagogram in Screening for Esophageal Fistula During Radiotherapy or Chemoradiotherapy for Esophageal Cancer.,"Background:  This study aimed to investigate the specificity and sensitivity of oral meglumine diatrizoate esophagogram in screening for esophageal fistula during radiotherapy or chemoradiotherapy for esophageal cancer and determine if early detection and intervention could improve the prognosis of esophageal fistulas.  Methods:  Esophageal cancer patients undergoing radiotherapy or chemoradiotherapy were included. Weekly oral meglumine diatrizoate esophagograms were performed to screen for esophageal fistulas during radiotherapy. When an esophageal fistula was detected, fibroesophagoscopy and computed tomography (CT) were used for confirmation; once confirmed, radiotherapy was discontinued, and the patient received intervention. The esophagogram results were reviewed weekly to assess the recovery of the esophageal fistula. If the fistula was healed, the patient resumed and completed radiotherapy.  Results:  A total of 206 patients with cancer of the esophagus undergoing chemotherapy/radiotherapy were included. During radiotherapy, 10 cases of esophageal fistula were detected or suspected based on the oral meglumine diatrizoate esophagography findings, and eight of those cases were confirmed by CT and esophagoscopy. All patients with esophageal fistula received intervention; among them, 62.5% (5/8) recovered after 1 to 2 weeks of treatment and continued radiotherapy to completion. The sensitivity and specificity of oral meglumine diatrizoate esophagography in screening for esophageal fistulas during radiotherapy or chemoradiotherapy were 100 and 98.9%, respectively. The median survival period of patients with esophageal fistulas was 6.4 months.  Conclusion:  Oral meglumine diatrizoate esophagography has high sensitivity and specificity in screening for esophageal fistulas during radiotherapy or chemoradiotherapy with minimal side effects. Early diagnosis and timely intervention can significantly improve the prognosis and prolong the survival period of patients.  Trial Registration:  Chictr.org.cn, Identifier: ChiCTR-DDD-17012617. Registered on September 7, 2017. The first participant was enrolled on September 25, 2017. http://www.chictr.org.cn/showproj.aspx?proj=21526.",2020,Oral meglumine diatrizoate esophagography has high sensitivity and specificity in screening for esophageal fistulas during radiotherapy or chemoradiotherapy with minimal side effects.,"['Esophageal Cancer', 'Esophageal cancer patients undergoing', '206 patients with cancer of the esophagus undergoing']","['Oral meglumine diatrizoate esophagography', 'radiotherapy or chemoradiotherapy', 'meglumine diatrizoate esophagograms', 'chemotherapy/radiotherapy', 'meglumine diatrizoate esophagogram', 'fibroesophagoscopy and computed tomography (CT', 'Radiotherapy or Chemoradiotherapy', 'meglumine diatrizoate esophagography', 'Oral Meglumine Diatrizoate Esophagogram']","['median survival period', 'sensitivity and specificity', 'Esophageal Fistula', 'recovery of the esophageal fistula']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152018', 'cui_str': 'Carcinoma of esophagus'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012005', 'cui_str': 'Meglumine diatrizoate'}, {'cui': 'C1318509', 'cui_str': 'Contrast radiography of esophagus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0014856', 'cui_str': 'Esophageal fistula'}]",206.0,0.0601248,Oral meglumine diatrizoate esophagography has high sensitivity and specificity in screening for esophageal fistulas during radiotherapy or chemoradiotherapy with minimal side effects.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Geng', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Dongbiao', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Oncology, Yan Ting County Cancer Hospital, Yanting County, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Yan Ting County Cancer Hospital, Yanting County, China.'}, {'ForeName': 'Yanqun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, Yan Ting County Cancer Hospital, Yanting County, China.'}, {'ForeName': 'Musheng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Mianyang Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xiang', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Bangxian', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.562147']
2202,33123554,Nasal high-flow oxygen  versus  noninvasive ventilation in acute exacerbation of COPD: protocol for a randomised noninferiority clinical trial.,"Background


Noninvasive ventilation (NIV) is considered as the first-line treatment for acute exacerbation of COPD (AECOPD) complicated by respiratory acidosis. Recent studies demonstrate a role of nasal high-flow oxygen (NHF) in AECOPD as an alternative treatment in patients intolerant to NIV or with contraindications to it.
Aim


The study aimed to evaluate whether NHF respiratory support is noninferior compared to NIV in respect to treatment failure, defined as need for intubation or change to alternative treatment group, in patients with AECOPD and mild-to-moderate acute or acute-on-chronic hypercapnic respiratory failure.
Methods


We designed a multicentre, prospective, randomised trial on patients with AECOPD, who have pH<7.35 but >7.25 and  P   aCO 2   >45 mmHg, in whom NIV is indicated as a first-line treatment. According to power analysis, 498 participants will be required for establishing noninferiority of NHF compared to NIV. Patients will be randomly assigned to receive NIV or NHF. Treatment will be adjusted to maintain  S   pO 2  between 88%-92% for both groups. Arterial blood gases, respiratory variables, comfort, dyspnoea score and any pulmonary or extrapulmonary complications will be assessed at baseline, before treatment initiation, and at 1, 2, 4, 6, 12, 24, 48 h, then once daily from day 3 to patient discharge, intubation or death.
Conclusion


Given the increasing number of studies demonstrating the physiological effects of NHF in COPD patients, we hypothesise that NHF respiratory support will be noninferior to NIV in patients with AECOPD and mild-to-moderate acute or acute on chronic hypercapnic respiratory failure.",2020,"According to power analysis, 498 participants will be required for establishing noninferiority of NHF compared to NIV.","['patients with AECOPD and mild-to-moderate acute or acute-on-chronic hypercapnic respiratory failure', 'patients with AECOPD, who have pH<7.35 but >7.25 and  P   aCO 2  \u2005>45\u2005mmHg, in whom NIV is indicated as a first-line treatment', '498 participants will be required for establishing noninferiority of NHF compared to NIV', 'acute exacerbation of COPD', 'patients intolerant to NIV or with contraindications to it']","['NIV or NHF', 'nasal high-flow oxygen (NHF) in AECOPD', 'Nasal high-flow oxygen  versus  noninvasive ventilation', '\n\n\nNoninvasive ventilation (NIV']","['Arterial blood gases, respiratory variables, comfort, dyspnoea score and any pulmonary or extrapulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4303980', 'cui_str': 'Acute on chronic hypercapnic respiratory failure'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",498.0,0.221353,"According to power analysis, 498 participants will be required for establishing noninferiority of NHF compared to NIV.","[{'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Papalampidou', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Bibaki', 'Affiliation': 'Respiratory Dept, Venizelio General Hospital, Athens, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Boutlas', 'Affiliation': 'Dept of Respiratory Medicine, School of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pantazopoulos', 'Affiliation': 'Emergency Dept, University Hospital of Larisa, Larissa, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Athanasiou', 'Affiliation': 'Pulmonary Dept, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Moylan', 'Affiliation': 'Dept of Epidemiology and Biostatistics, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Vlachakos', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Grigoropoulos', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Eleftheriou', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Daniil', 'Affiliation': 'Dept of Respiratory Medicine, School of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gourgoulianis', 'Affiliation': 'Dept of Respiratory Medicine, School of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kalomenidis', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Zakynthinos', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Ischaki', 'Affiliation': 'First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.'}]",ERJ open research,['10.1183/23120541.00114-2020']
2203,33123558,"Inhaled dry powder alginate oligosaccharide in cystic fibrosis: a randomised, double-blind, placebo-controlled, crossover phase 2b study.","Background


OligoG is a low molecular-weight alginate oligosaccharide that improves the viscoelastic properties of cystic fibrosis (CF) mucus and disrupts biofilms, thereby potentiating the activity of antimicrobial agents. The efficacy of inhaled OligoG was evaluated in adult patients with CF.
Methods


A randomised, double-blind, placebo-controlled multicentre crossover study was used to demonstrate safety and efficacy of inhaled dry powder OligoG. Subjects were randomly allocated to receive OligoG 1050 mg per day (10 capsules three times daily) or matching placebo for 28 days, with 28-day washout periods following each treatment period. The primary end-point was absolute change in percentage predicted forced expiratory volume in 1 s (FEV 1 ) at the end of 28-day treatment. The intention-to-treat (ITT) population (n=65) was defined as randomised to treatment with at least one administration of study medication and post-dosing evaluation.
Results


In this study, 90 adult subjects were screened and 65 were randomised. Statistically significant improvement in FEV 1  was not observed in the ITT population. Adverse events included nasopharyngitis, cough and pulmonary exacerbation. The number and proportions of patients with adverse events and serious adverse events were similar between OligoG and placebo group.
Conclusions


Inhalation of OligoG-dry powder over 28 days was safe in adult CF subjects. Statistically significant improvement of FEV 1  was not reached. The planned analyses did not indicate a significant treatment benefit with OligoG compared to placebo.  Post hoc  exploratory analyses showed subgroup results that indicate that further studies of OligoG in this patient population are justified.",2020,Statistically significant improvement of FEV 1  was not reached.,"['adult CF subjects', '90 adult subjects were screened and 65 were randomised', 'adult patients with CF', 'cystic fibrosis']","['Inhaled dry powder alginate oligosaccharide', 'placebo', 'matching placebo', 'OligoG', 'inhaled OligoG', 'OligoG-dry powder']","['safety and efficacy', 'absolute change in percentage predicted forced expiratory volume', 'number and proportions of patients with adverse events and serious adverse events', 'FEV 1', 'nasopharyngitis, cough and pulmonary exacerbation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",90.0,0.488066,Statistically significant improvement of FEV 1  was not reached.,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'van Koningsbruggen-Rietschel', 'Affiliation': ""CF Centre, Faculty of Medicine, University Children's Hospital, Cologne, Germany.""}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'Dept of Paediatric Respiratory Medicine, National Heart and Lung Institute, Imperial College London, and Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tacjana', 'Initials': 'T', 'LastName': 'Pressler', 'Affiliation': 'Copenhagen CF Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Pneumologische Praxis Pasing, Munich, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'MacGregor', 'Affiliation': 'Dept of Respiratory Medicine, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Donaldson', 'Affiliation': 'Dept of Medicine, UNC School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Smerud', 'Affiliation': 'SMERUD Medical Research International AS, Oslo, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Meland', 'Affiliation': 'SMERUD Medical Research International AS, Oslo, Norway.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Mortensen', 'Affiliation': 'Copenhagen CF Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marie Ø', 'Initials': 'MØ', 'LastName': 'Fosbøl', 'Affiliation': 'Copenhagen CF Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University, Belfast, UK.""}, {'ForeName': 'Astrid H', 'Initials': 'AH', 'LastName': 'Myrset', 'Affiliation': 'AlgiPharma AS, Sandvika, Norway.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Flaten', 'Affiliation': 'AlgiPharma AS, Sandvika, Norway.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Rye', 'Affiliation': 'AlgiPharma AS, Sandvika, Norway.'}]",ERJ open research,['10.1183/23120541.00132-2020']
2204,33123594,The Effects of Supersaturated Hydrogen-Rich Water Bathing on Biomarkers of Muscular Damage and Soreness Perception in Young Men Subjected to High-Intensity Eccentric Exercise.,"High-intensity eccentric exercise can cause a delayed onset of muscle soreness (DOMS), a short-term condition characterized by muscle damage and tenderness that might hold up recovery and jeopardize exercise routine. Previous studies indicated that hydrogen-rich water (HRW) might be a helpful topical intervention to boost recovery in musculoskeletal medicine, yet no data are available concerning the effectiveness and safety of whole-body bathing with supersaturated HRW after DOMS-inducing exercise. This study evaluates the effects of a single-session bathing with HRW on biochemical markers of muscular damage in healthy young men. The six volunteers who were exposed to DOMS-inducing eccentric exercise were assigned to either supersaturated HRW or control whole-body bathing in a double-blind crossover design. Immediately after an exercise session, the participants were immersed up to the neck into a 200 L bathtub with supersaturated HRW (8 mg of H 2  per L) or control water (no hydrogen) for 30 min. Blood biomarkers of inflammation and muscular damage and Visual Analogue Scale (VAS) scores for muscle soreness were assessed at baseline (before exercise) and at 24-hour follow-up. Two-way ANOVA revealed a significant difference between two groups in serum creatine kinase (CK) response over the period of intervention ( P =0.04). A single-session bathing in HRW prevented a rise in circulating biomarkers of muscular damage induced by exercise at 24-hour follow-up, retaining the levels of all biomarkers similar to the baseline values ( P  > 0.05). On the other hand, serum CK, aldolase, and aspartate transaminase were significantly elevated at 24-hour follow-up as compared to the baseline levels after the control bath (342 ± 309 U/L vs. 465 ± 295 U/L;  P  > 0.05). HRW bath also induced a significant drop in VAS scores for muscle soreness in comparison with control water, both immediately after an intervention (32.7 ± 8.6% vs. 20.0 ± 12.8%;  P =0.02) and at 24-hour follow-up (31.6 ± 24.3% vs. 22.4 ± 27.5%;  P =0.03), respectively. No participants reported any major side effects during the trial. This pilot study suggests that the whole-body bathing in supersaturated HRW is a safe procedure that attenuates muscular damage and can ease sore muscles after high-intensity eccentric exercise.",2020,"HRW bath also induced a significant drop in VAS scores for muscle soreness in comparison with control water, both immediately after an intervention (32.7 ± 8.6% vs. 20.0 ± 12.8%;  P =0.02) and at 24-hour follow-up (31.6 ± 24.3% vs. 22.4 ± 27.5%;  P =0.03), respectively.","['six volunteers who were exposed to DOMS-inducing eccentric exercise', 'Young Men Subjected to High-Intensity Eccentric Exercise', 'healthy young men']","['Supersaturated Hydrogen-Rich Water Bathing', 'single-session bathing with HRW', 'High-intensity eccentric exercise', 'hydrogen-rich water (HRW', 'supersaturated HRW (8\u2009mg of H 2  per\u2009L) or control water (no hydrogen', 'supersaturated HRW or control whole-body bathing']","['serum creatine kinase (CK) response', 'major side effects', 'Muscular Damage and Soreness Perception', 'serum CK, aldolase, and aspartate transaminase', 'circulating biomarkers of muscular damage', 'Blood biomarkers of inflammation and muscular damage and Visual Analogue Scale (VAS) scores for muscle soreness', 'VAS scores for muscle soreness']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001990', 'cui_str': 'Aldehyde-lyase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0474181,"HRW bath also induced a significant drop in VAS scores for muscle soreness in comparison with control water, both immediately after an intervention (32.7 ± 8.6% vs. 20.0 ± 12.8%;  P =0.02) and at 24-hour follow-up (31.6 ± 24.3% vs. 22.4 ± 27.5%;  P =0.03), respectively.","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Todorovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad 21000, Serbia.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Javorac', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad 21000, Serbia.'}, {'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Stajer', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad 21000, Serbia.'}, {'ForeName': 'Sergej M', 'Initials': 'SM', 'LastName': 'Ostojic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad 21000, Serbia.'}]",Journal of sports medicine (Hindawi Publishing Corporation),['10.1155/2020/8836070']
2205,33123653,Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial.,"Context


The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon's glucose-lowering properties can be leveraged in individuals with prediabetes.
Objective


The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes.
Design Setting Participants and Intervention


This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks.
Main Outcome Measures


Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT.
Results


From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL ( P  < .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05). There were no serious adverse events in either study group.
Conclusions


In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon's effects on the rate of progression from prediabetes to T2D.",2020,"When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05).","['adult individuals meeting any criteria for prediabetes to receive', 'individuals with prediabetes', 'prediabetes', 'Participants were enrolled and followed at 2 academic centers for 12 weeks', 'Individuals With Prediabetes']","['cinnamon supplementation', 'Cinnamon', 'placebo', 'cinnamon 500 mg or placebo']","['FPG and glucose tolerance', 'fasting plasma glucose (FPG', 'change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC', 'AUC PG', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.503134,"When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05).","[{'ForeName': 'Giulio R', 'Initials': 'GR', 'LastName': 'Romeo', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Junhee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, Dongdaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Mulla', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Noh', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Holden', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Byung-Cheol', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, Dongdaemun-gu, Seoul, Republic of Korea.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa094']
2206,33123662,TightRope Versus Biocomposite Interference Screw for Fixation in Allograft ACL Reconstruction: Prospective Evaluation of Osseous Integration and Patient Outcomes.,"Background


Anterior cruciate ligament (ACL) reconstruction is a commonly performed procedure with many options regarding graft choice and graft fixation. The purpose of this study was to compare suspensory and aperture fixation in terms of femoral osseous integration of the bone block after ACL reconstruction with an Achilles tendon allograft.
Methods


After institutional review board approval and patient consent were obtained, 37 patients underwent ACL reconstruction with an Achilles tendon allograft. The patients were randomized according to the graft femoral fixation technique, which was with either a suspensory device (Arthrex TightRope) or aperture fixation by a biocomposite interference screw (Arthrex BioComposite Interference Screw or DePuy Mitek MILAGRO Interference Screw). Tibial fixation, performed with a biocomposite screw and knotless anchor, was identical in all patients. All patients underwent a computed tomography (CT) scan at 6 months to evaluate bone block incorporation of the femoral graft within the femoral tunnel, which was the study's primary outcome. Secondary outcome measures included a postoperative visual analogue scale (VAS) pain score, range-of-motion measures, and International Knee Documentation Committee scores. Demographic data were collected.
Results


Thirty-three patients (89%) completed the study's 6-month follow-up, at which time the femoral ossification score was significantly greater in the aperture fixation group (p = 0.025). There was no substantial difference between the 2 groups with regard to any other outcome measure.
Conclusions


Performing Achilles tendon allograft ACL reconstruction with femoral aperture fixation results in greater femoral bone block incorporation at 6 months postoperatively compared with what is seen after suspensory fixation.
Level of Evidence


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"There was no substantial difference between the 2 groups with regard to any other outcome measure.
",['37 patients underwent'],"['ACL reconstruction', 'ACL reconstruction with an Achilles tendon allograft', 'Achilles tendon allograft ACL reconstruction with femoral aperture fixation', 'biocomposite screw and knotless anchor', 'TightRope Versus Biocomposite Interference Screw', 'graft femoral fixation technique', '\n\n\nAnterior cruciate ligament (ACL) reconstruction', 'suspensory device (Arthrex TightRope) or aperture fixation by a biocomposite interference screw (Arthrex BioComposite Interference Screw or DePuy Mitek MILAGRO Interference Screw', 'computed tomography (CT) scan', 'suspensory and aperture fixation']","['postoperative visual analogue scale (VAS) pain score, range-of-motion measures, and International Knee Documentation Committee scores', 'femoral bone block incorporation', 'femoral ossification score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",,0.0798288,"There was no substantial difference between the 2 groups with regard to any other outcome measure.
","[{'ForeName': 'Shahram Shawn', 'Initials': 'SS', 'LastName': 'Yari', 'Affiliation': 'Department of Orthopedic Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Ashraf N', 'Initials': 'AN', 'LastName': 'El Naga', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Departments of Radiology (A.P.) and Orthopedic Surgery (A.S.), Kelsey-Seybold Clinic, Houston, Texas.'}, {'ForeName': 'Ali Asaf', 'Initials': 'AA', 'LastName': 'Qadeer', 'Affiliation': 'Department of Orthopedic Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Departments of Radiology (A.P.) and Orthopedic Surgery (A.S.), Kelsey-Seybold Clinic, Houston, Texas.'}]",JB & JS open access,['10.2106/JBJS.OA.19.00057']
2207,33123666,Wear Rates of XLPE Nearly 50% Lower Than Previously Thought After Adjusting for Initial Creep: An RCT Comparing 4 Bearing Combinations.,"Background


The ideal bearing combination for total hip arthroplasty (THA) remains debatable. Highly cross-linked polyethylene (XLPE) is widely used, but long-term wear rates are not fully known, nor is how much the initial ""creep,"" if any, affects overall wear. Additionally, the use of oxidized zirconium (OxZir) is purported to lower polyethylene wear rates, but this has not been proven. We present the 10-year data of a cohort of patients who underwent THA. Patients were prospectively randomized to 1 of 4 bearing combinations: a conventional ultra-high molecular weight polyethylene (UHMWPE) or XLPE acetabular liner coupled with either a cobalt-chromium (CoCr) or OxZir femoral head. The aims of the study were to (1) assess the extent to which creep affected overall wear rates and (2) assess wear rates between OxZir and CoCr with polyethylene.
Methods


A total of 92 hips (92 patients) between the ages of 22 and 65 years (mean, 52.2 ± 9.3 years) were randomized to 4 groups. At 10 years, 70 (76%) of the hips were available for analysis; patients who had undergone revision, had died, or were lost to follow-up were excluded from final analysis. Radiographic analysis was performed using a validated digital assessment program to determine linear, volumetric, and directional wear of the polyethylene for all 4 bearing couples. Radiographic assessments were performed immediately postoperatively, at 6 and 12 weeks, and then annually for a minimum of 10 years.
Results


XLPE had significantly lower wear rates than UHMWPE. Once creep was eliminated, annual and overall wear rates were nearly 50% lower than have been previously reported. This was proportionally more important in the XLPE group than in the UHMWPE group. There was a nonsignificant trend toward a lower wear rate with OxZir heads.
Conclusions


Creep plays a notably more important role than first thought. Once creep was eliminated, the overall wear rate was even lower than previously assumed. This has important implications for the overall survivorship of hip arthroplasty implants.
Level of Evidence


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Results


XLPE had significantly lower wear rates than UHMWPE.","['92 hips (92 patients) between the ages of 22 and 65 years (mean, 52.2 ± 9.3 years', 'At 10 years, 70 (76%) of the hips were available for analysis; patients who had undergone revision, had died, or were lost to follow-up were excluded from final analysis']","['oxidized zirconium (OxZir', 'conventional ultra-high molecular weight polyethylene (UHMWPE) or XLPE acetabular liner coupled with either a cobalt-chromium (CoCr) or OxZir femoral head', 'THA', 'Highly cross-linked polyethylene (XLPE', 'XLPE', 'UHMWPE']","['overall wear rate', 'Radiographic assessments', 'Wear Rates of XLPE', 'overall wear rates and (2) assess wear rates']","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C1961397', 'cui_str': 'Acetabular liner'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",92.0,0.122136,"Results


XLPE had significantly lower wear rates than UHMWPE.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khoshbin', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ward', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Luana T', 'Initials': 'LT', 'LastName': 'Melo', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Schulitsch School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Waddell', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Atrey', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}]",JB & JS open access,['10.2106/JBJS.OA.19.00066']
2208,33123690,A double-blinded randomised controlled study to investigate the effect of intraperitoneal levobupivacaine on post laparoscopic pain.,"Background


Laparoscopic surgery is the cornerstone of modern gynaecological surgery, with shorter hospital stays and a quicker return to normal activities. However postoperative pain remains problematic. No strategy to reduce phrenic nerve irritation, including heating or humidifying the insufflating gas, alternatives to CO 2 , and intraperitoneal analgesics, has shown superiority.
Methods


100 women undergoing laparoscopic surgery were randomly allocated, having either 40ml of 0.25% levobupivacaine or 40ml 0.9% sodium chloride solution administered into the peritoneal cavity following surgery. The patients and the main researcher were blinded. All women received standardised anaesthetic and laparoscopic technique, and postoperative pain control including nursing position and nature of analgesia. Postoperative pain was assessed 3 hours, 8 hours, day 1 and day 4/5 postoperatively.
Results


100 patients were recruited undergoing surgery for benign causes aged 19-73(mean 40.3±13). There was no difference between the groups for age(p=0.64) or length of operation(p=0.56). There were no adverse events related to use of intraperitoneal instillation. There was a significant reduction in shoulder-tip pain scores in the levobupivacaine group at 3 hours(p=0.04). Furthermore, there was a significant reduction in wound-pain scores in the levobupivacaine group at 8hrs(p=0.04) and at day 4(p=0.04). No difference was found in pelvic pain between the two groups. No significant difference was found in the use of post-operative analgesia.
Conclusions


Intraperitoneal instillation of 40ml of levobupivacaine has some benefit in reducing postoperative pain and need for analgesia in the initial hours following gynaecological surgery. However, further well-designed randomised control trials are required to decide the optimum route and concentration of administering local anaesthetic.",2020,There was a significant reduction in shoulder-tip pain scores in the levobupivacaine group at 3 hours(p=0.04).,"['100 patients were recruited undergoing surgery for benign causes aged 19-73(mean 40.3±13', '100 women undergoing laparoscopic surgery']","['levobupivacaine or 40ml 0.9% sodium chloride solution', 'standardised anaesthetic and laparoscopic technique, and postoperative pain control including nursing position and nature of analgesia', '\n\n\nLaparoscopic surgery', 'intraperitoneal levobupivacaine', 'levobupivacaine']","['wound-pain scores', 'shoulder-tip pain scores', 'Postoperative pain', 'pelvic pain', 'postoperative pain and need for analgesia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}]","[{'cui': 'C0241745', 'cui_str': 'Wound pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",100.0,0.282391,There was a significant reduction in shoulder-tip pain scores in the levobupivacaine group at 3 hours(p=0.04).,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Cunningham', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Draper', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bexhell', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Centre for Health and Population Sciences, Hull York Medical School, Hull, United Kingdom, HU6 7RX.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mikl', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, HU32JZ.'}]","Facts, views & vision in ObGyn",[]
2209,33123781,Otoplasty: Rasps or Puncture Needles? A Clinical Trial.,"BACKGROUND


Up to 25% of otoplasties can lead to complications, indicating the need for technical refinement. Stenström's anterior auricular cartilage scoring is used in combination with Mustardé's technique to treat the antihelix deformity in several series, with good results. Both can be performed with different instruments such as rasps or puncture needles.
OBJECTIVES


This study aims to compare the use of puncture needles and rasps for anterior cartilage scoring in otoplasty. The association of Stenström and Mustardé were the basic technique. Anatomical and aesthetic endpoints were assessed. We also reviewed postoperative complications.
METHODS


Forty-two patients with prominent ears and no previous surgery were randomly assigned needle or rasps technique. They were operated on by the first-year plastic surgery resident in the years of 2014 and 2019. The patients were followed up and reviewed at days 2 and 15, as well as 1, 3 and 6 months postoperatively. The endpoints were evaluated through pre- and postoperative photographs by four experienced plastic surgeons unaware of the techniques used in each case. Patient satisfaction was searched by a ""yes"" or ""no"" question. Surgical time and postoperative edema were evaluated in 20 patients (2014 group).
RESULTS


There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture. Ninety-five percent of the patients were satisfied with the outcome. The needle technique resulted in less postoperative edema and shorter surgical time.
CONCLUSION


Anterior cartilage scoring used in combination with posterior mattress sutures to treat poorly formed antihelical fold has good and similar results when performed with rasps or puncture needles, even in unexperienced hands. The needle has the advantage of leading to a comparable surgical time and less postoperative edema, while not requiring any special surgical instrument.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the table of contents or the online instructions to authors www.springer.com/00266 .",2020,"There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture.","['20 patients (2014 group', 'otoplasty', 'Forty-two patients with prominent ears and no previous surgery']","['puncture needles and rasps', 'IV', 'needle or rasps technique']","['postoperative edema and shorter surgical time', 'Surgical time and postoperative edema', 'overall results, symmetry, antihelix shape or cartilage fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868838', 'cui_str': 'Repair of external ear'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C1305420', 'cui_str': 'Prominent ear'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0995147', 'cui_str': 'Rasp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0229308', 'cui_str': 'Antihelix structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1564560', 'cui_str': 'Cartilage Fractures'}]",42.0,0.0359251,"There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture.","[{'ForeName': 'Eduardo Madalosso', 'Initials': 'EM', 'LastName': 'Zanin', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil. eduardo.zanin@gmail.com.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Maximiliano', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Antônio Carlos Pinto', 'Initials': 'ACP', 'LastName': 'Oliveira', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Nícolas Endrigo', 'Initials': 'NE', 'LastName': 'Arpini', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul Medical School, Porto Alegre-RS, Brazil.'}, {'ForeName': 'Daniele Walter', 'Initials': 'DW', 'LastName': 'Duarte', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Ciro Paz', 'Initials': 'CP', 'LastName': 'Portinho', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Marcus Vinicius Martins', 'Initials': 'MVM', 'LastName': 'Collares', 'Affiliation': 'Head of the Plastic Surgery Division, Hospital de Clínicas de Porto Alegre, Porto Alegre-RS, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01972-z']
2210,33123819,The effects of caffeine on olfactory function and mood: an exploratory study.,"Caffeine has been demonstrated to enhance olfactory function in rodents, but to date, the sparse research in humans has not shown any equivalent effects. However, due to the methodological nature of those human studies, a number of questions remain unanswered, which the present study aimed to investigate. Using a double-blind experimental design, participants (n = 40) completed baseline mood measures, standardised threshold and identification tests and were then randomly allocated to receive a capsule containing either 100 mg of caffeine or placebo, followed by the same olfactory tests and mood measures. Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function. In contrast, for non-caffeine consumers, caffeine acted to enhance odour (threshold) sensitivity but reduce odour identification. Overall, these findings demonstrate a complex profile of effects of caffeine on odour function and, given the evidence from the wider caffeine literature, it is proposed that the effects of caffeine might be limited to older populations.",2020,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","['participants (n = 40) completed baseline mood measures, standardised threshold and identification tests']","['capsule containing either 100 mg of caffeine or placebo', 'caffeine', 'Caffeine']","['odour function', 'olfactory function and mood']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0748987,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","[{'ForeName': 'Lorenzo D', 'Initials': 'LD', 'LastName': 'Stafford', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK. lorenzo.Stafford@port.ac.uk.'}, {'ForeName': 'Kaylee', 'Initials': 'K', 'LastName': 'Orgill', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK.'}]",Psychopharmacology,['10.1007/s00213-020-05695-6']
2211,33123838,Randomized Controlled Trial of an Integrated Family-Based Treatment for Adolescents Presenting to Community Mental Health Centers.,"Most adolescents presenting to community mental health centers have one or more comorbidities (internalizing, externalizing, and substance use problems). We evaluated an integrated family-based outpatient treatment for adolescents (OPT-A) that can be delivered in a community mental health center by a single therapist. A sample of 134 youth/families were randomized to receive OPT-A or usual services, delivered at the same public sector mental health center. Repeated, multi-informant assessments occurred through 18-months post-baseline. At baseline, the sample displayed low internalizing symptoms, moderate substance use, and high externalizing problems. Compared to usual services, OPT-A had effects on abstinence rates, retention, motivation, parent involvement, and satisfaction, but not on internalizing or externalizing problems. While OPT-A achieved some key improvements for youth who present to community mental health centers, and families were satisfied with treatment, continued work is necessary to examine treatments for comorbidity while balancing treatment feasibility and complex strategies to boost treatment effectiveness.",2020,"Compared to usual services, OPT-A had effects on abstinence rates, retention, motivation, parent involvement, and satisfaction, but not on internalizing or externalizing problems.","['Most adolescents presenting to community mental health centers', 'Adolescents Presenting to Community Mental Health Centers', '134 youth/families']","['Integrated Family-Based Treatment', 'OPT-A or usual services, delivered at the same public sector mental health center']","['abstinence rates, retention, motivation, parent involvement, and satisfaction', 'internalizing or externalizing problems']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",134.0,0.0905881,"Compared to usual services, OPT-A had effects on abstinence rates, retention, motivation, parent involvement, and satisfaction, but not on internalizing or externalizing problems.","[{'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97401, USA.'}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT, 06030, USA. zajac@uchc.edu.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97401, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97401, USA.'}, {'ForeName': 'Tess K', 'Initials': 'TK', 'LastName': 'Drazdowski', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97401, USA.'}]",Community mental health journal,['10.1007/s10597-020-00735-z']
2212,33123853,Experiences of using an activating spinal orthosis in women with osteoporosis and back pain in primary care.,"Women with osteoporosis and back pain took part in focus group interviews and described their experiences of using and handling an activating spinal orthosis. The women described the back orthosis as being like a ""close friend"", a support in everyday life and a reminder to maintain a good posture.
PURPOSE


The purpose of this study was to describe and gain a deeper understanding of the views of older women with osteoporosis and back pain seeking primary care regarding their use and handling of an activating spinal orthosis.
METHOD


We chose a qualitative method whereby information was gathered via focus group interviews and analysed using inductive content analysis. Women who previously participated in a randomised controlled trial and wore an activating spinal orthosis for 6 months were asked. Out of 31 women, 18 agreed to participate. Five focus group interviews were conducted.
RESULTS


The analysis resulted in an overall theme in which the experiences of wearing the spinal orthosis were described as follows: ""A well-adapted spinal orthosis could develop into a long-lasting friendship that provided support and help in daily life"". The overall theme was based on three main categories: impact on daily life, individual adaptation and personal relationship. The main categories were well differentiated from each other but had an interdependency. All three categories involved cases in which the spinal orthosis was perceived as relieving symptoms and making daily life easier, as well as when it was perceived as being hard to manage and provided no symptom relief.
CONCLUSION


In older women with osteoporosis and back pain, an activating spinal orthosis could be perceived as being a ""close friend"" and a support in everyday life. To facilitate acceptance of the spinal orthosis, it was important for it to be well adapted and for follow-ups to be carried out regularly.",2020,"In older women with osteoporosis and back pain, an activating spinal orthosis could be perceived as being a ""close friend"" and a support in everyday life.","['older women with osteoporosis and back pain', '31 women, 18 agreed to participate', 'Women with osteoporosis and back pain', 'older women with osteoporosis and back pain seeking primary care', 'women with osteoporosis and back pain in primary care']",[],"['relieving symptoms and making daily life easier', 'daily life, individual adaptation and personal relationship']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",31.0,0.0468793,"In older women with osteoporosis and back pain, an activating spinal orthosis could be perceived as being a ""close friend"" and a support in everyday life.","[{'ForeName': 'Christina Kaijser', 'Initials': 'CK', 'LastName': 'Alin', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Family Medicine and Primary Care, Karolinska Institutet, Solna, Sweden. christina.kaijser.alin@ki.se.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Frisendahl', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Solna, Sweden.'}, {'ForeName': 'Ann-Charlotte Grahn', 'Initials': 'AG', 'LastName': 'Kronhed', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Mjölby, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Salminen', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Family Medicine and Primary Care, Karolinska Institutet, Solna, Sweden.'}]",Archives of osteoporosis,['10.1007/s11657-020-00754-z']
2213,30982715,A Prospective Cohort Study on the Effects of Geriatric Rehabilitation Following Acute Exacerbations of COPD.,"OBJECTIVES


Older patients with chronic obstructive pulmonary disease (COPD), hospitalized for an acute exacerbation, often do not receive recommended post-acute pulmonary rehabilitation. This underuse might be related to the impaired clinical and functional status of these patients, who are more likely to present with frailty, comorbidities, and disability. Having developed and implemented a geriatric rehabilitation program for these patients (GR_COPD), the primary aim of this study was to investigate the effectiveness of this program.
DESIGN AND INTERVENTION


A prospective cohort study with a 3-month follow-up period. Patients who declined the GR_COPD program were considered as controls.
SETTING AND PARTICIPANTS


The study was conducted at the pulmonary department of 2 hospitals. Patients were eligible when hospitalized as a result of an acute exacerbation of COPD and indicated for the GR_COPD program based on standardized criteria.
METHODS


Primary outcome was defined as change in disease-specific health status measured with the clinical COPD questionnaire (CCQ), secondary outcome as the exacerbation rate ratio during follow-up. To balance potential confounders between the intervention and control group, propensity score-based weighted linear regression analyses were performed.
RESULTS


Of the 158 included patients [78 (49.4%) male, mean age 70.8 (±8.1) years, mean forced expiratory volume in 1 second: 35.5 (±12.8) as % of predicted], 78 received the GR_COPD program. The results of the CCQ showed a significant and clinically relevant treatment effect of -0.56 points [95% confidence interval (CI) -0.89, -0.23; P = .001). Patients in the control group had 2.77 times more exacerbations compared with the intervention group (95% CI 2.13, 3.58; P < .001).
CONCLUSIONS/IMPLICATIONS


This study shows a clinically relevant effect of the GR_COPD program on disease-specific health status and exacerbation rate. Implementation of the program for older patients with severe COPD hospitalized for an acute exacerbation is recommended.",2019,"Patients in the control group had 2.77 times more exacerbations compared with the intervention group (95% CI 2.13, 3.58; P < .001).
","['Acute Exacerbations of COPD', 'Older patients with chronic obstructive pulmonary disease (COPD), hospitalized for an acute exacerbation, often do not receive recommended post-acute pulmonary rehabilitation', 'Of the 158 included patients [78 (49.4%) male, mean age 70.8 (±8.1) years', 'Patients were eligible when hospitalized as a result of an acute exacerbation of COPD and indicated for the GR_COPD program based on standardized criteria', 'older patients with severe COPD hospitalized for an acute exacerbation', 'pulmonary department of 2 hospitals']","['GR_COPD program', 'Geriatric Rehabilitation', 'geriatric rehabilitation program']","['disease-specific health status and exacerbation rate', 'mean forced expiratory volume', 'exacerbations', 'change in disease-specific health status measured with the clinical COPD questionnaire (CCQ), secondary outcome as the exacerbation rate ratio']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",158.0,0.0518073,"Patients in the control group had 2.77 times more exacerbations compared with the intervention group (95% CI 2.13, 3.58; P < .001).
","[{'ForeName': 'Eléonore F', 'Initials': 'EF', 'LastName': 'van Dam van Isselt', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, the Netherlands; Zorggroep Solis, Deventer, the Netherlands. Electronic address: E.F.vanDamvanIsselt@lumc.nl.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'van Eijk', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Centre, the Netherlands.'}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Groenewegen-Sipkema', 'Affiliation': 'Deventer Hospital, Pulmonary Department, Deventer, the Netherlands.'}, {'ForeName': 'Jan-Willem K', 'Initials': 'JK', 'LastName': 'van den Berg', 'Affiliation': 'Isala Hospital, Pulmonary Department, Zwolle, the Netherlands.'}, {'ForeName': 'Cécile M A', 'Initials': 'CMA', 'LastName': 'Nieuwenhuys', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, the Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, the Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.02.025']
2214,31383649,Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study.,"BACKGROUND/AIMS


Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity.
METHODS


SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed.
RESULTS


One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of -30.75 µm (95% CI -59.50,-20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0-≥15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters). No new safety signals were identified.
CONCLUSION


Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.",2020,"However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters).","['neovascular age-related macular degeneration in Europe', 'Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response', 'One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99', 'patients with neovascular age-related macular degeneration (nAMD', 'patients with nAMD', 'patients with persistent/recurrent disease activity']","['intravitreal ranibizumab injections', 'switching from aflibercept to ranibizumab', 'ranibizumab', 'switching anti-vascular endothelial growth factors']","['mean improvements in BCVA (CfB', 'change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT', 'CSRT', 'BCVA', 'Best-corrected visual acuity (BCVA) and retinal morphology parameters']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",100.0,0.14207,"However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters).","[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': 'York Teaching Hospital NHS Foundation Trust, York, UK richard.gale@york.nhs.uk.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pearce', 'Affiliation': 'Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Eter', 'Affiliation': 'Department of Ophthalmology, University of Münster Medical Center, Münster, Germany.'}, {'ForeName': 'Faruque', 'Initials': 'F', 'LastName': 'Ghanchi', 'Affiliation': 'Bradford Teaching Hospitals NHS Trust, Bradford, UK.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'GRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmitz-Valckenberg', 'Affiliation': 'GRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Balaskas', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben J L', 'Initials': 'BJL', 'LastName': 'Burton', 'Affiliation': 'James Paget University Hospitals NHS Foundation Trust, Great Yarmouth, UK.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Downes', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Haralabos', 'Initials': 'H', 'LastName': 'Eleftheriadis', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilmour', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lotery', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Nishal', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Prakash', 'Affiliation': 'Princess Alexandra Hospital NHS Trust, Harlow, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Santiago', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Saju', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'County Durham and Darlington NHS Foundation Trust, Darlington, UK.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Varma', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Harrogate and District NHS Foundation Trust, Harrogate, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'University of Munich, Munich, Germany.'}, {'ForeName': 'Rosina H', 'Initials': 'RH', 'LastName': 'Zakri', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Igwe', 'Affiliation': 'Novartis Pharmaceuticals UK Ltd, Surrey, UK.'}, {'ForeName': 'Filis', 'Initials': 'F', 'LastName': 'Ayan', 'Affiliation': 'Novartis Pharmaceuticals UK Ltd, Surrey, UK.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314251']
2215,31515403,Lumbar transcutaneous electrical nerve stimulation to improve exercise performance in COPD patients.,,2019,,['COPD patients'],['Lumbar transcutaneous electrical nerve stimulation'],['exercise performance'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0130477,,"[{'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'ADIR Association, Rouen University Hospital, Rouen, France rehabilitation@adir-hautenormandie.com.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'ADIR Association, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute Normandie Research and Biomedical Innovation, Rouen, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Physiotherapy Dept, Le Havre Hospital, Le Havre, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Debeaumont', 'Affiliation': 'Dept of Respiratory and Exercise Physiology and CIC-CRB 1404, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Patout', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute Normandie Research and Biomedical Innovation, Rouen, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute Normandie Research and Biomedical Innovation, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Muir', 'Affiliation': 'ADIR Association, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Médrinal', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute Normandie Research and Biomedical Innovation, Rouen, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Cuvelier', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute Normandie Research and Biomedical Innovation, Rouen, France.'}]",The European respiratory journal,['10.1183/13993003.00784-2019']
2216,32107374,Risk-adjusted therapy for pediatric non-T cell ALL improves outcomes for standard risk patients: results of JACLS ALL-02.,"This study was a second multicenter trial on childhood ALL by the Japan Childhood Leukemia Study Group (JACLS) to improve outcomes in non-T ALL. Between April 2002 and March 2008, 1138 children with non-T ALL were enrolled in the JACLS ALL-02 trial. Patients were stratified into three groups using age, white blood cell count, unfavorable genetic abnormalities, and treatment response: standard risk (SR), high risk (HR), and extremely high risk (ER). Prophylactic cranial radiation therapy (PCRT) was abolished except for CNS leukemia. Four-year event-free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates for all patients were 85.4% ± 1.1% and 91.2% ± 0.9%, respectively. Risk-adjusted therapy resulted in 4yr-EFS rates of 90.4% ± 1.4% for SR, 84.9% ± 1.6% for HR, and 66.5% ± 4.0% for ER. Based on NCI risk classification, 4yr-EFS rates were 88.2% in NCI-SR and 76.4% in NCI-HR patients, respectively. Compared to previous trial ALL-97, 4yr-EFS of NCI-SR patients was significantly improved (88.2% vs 81.2%, log rank p = 0.0004). The 4-year cumulative incidence of isolated (0.9%) and total (1.5%) CNS relapse were significantly lower than those reported previously. In conclusion, improved EFS in NCI-SR patients and abolish of PCRT was achieved in ALL-02.",2020,"Four-year event-free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates for all patients were 85.4% ± 1.1% and 91.2% ± 0.9%, respectively.","['Between April 2002 and March 2008, 1138 children with non-T ALL were enrolled in the JACLS ALL-02 trial', 'standard risk patients', 'Patients were stratified into three groups using age, white blood cell count, unfavorable genetic abnormalities, and treatment response: standard risk (SR), high risk (HR), and extremely high risk (ER']","['Prophylactic cranial radiation therapy (PCRT', 'JACLS ALL-02']","['free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates', 'NCI risk classification, 4yr-EFS rates', '4-year cumulative incidence', '4yr-EFS rates', 'CNS relapse']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023493', 'cui_str': 'Adult T-cell leukemia/lymphoma'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",1138.0,0.0408788,"Four-year event-free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates for all patients were 85.4% ± 1.1% and 91.2% ± 0.9%, respectively.","[{'ForeName': 'Daiichiro', 'Initials': 'D', 'LastName': 'Hasegawa', 'Affiliation': ""Department of Hematology/Oncology, Hyogo Prefectural Children's Hospital, Kobe, Japan.""}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': 'Department of Pediatrics, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan. imamura@koto.kpu-m.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Yumura-Yagi', 'Affiliation': 'Yumura Clinic, Osaka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, Aomori Prefectural Central Hospital, Aomori, Japan.'}, {'ForeName': 'Ikuya', 'Initials': 'I', 'LastName': 'Usami', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'So-Ichi', 'Initials': 'SI', 'LastName': 'Suenobu', 'Affiliation': 'Division of General Pediatrics and Emergency Medicine, Department of Pediatrics, Oita University, Oita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nishimura', 'Affiliation': 'Department of Pediatrics, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pediatrics, Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Hashii', 'Affiliation': 'Department of Pediatrics, Osaka University, Suita, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Deguchi', 'Affiliation': 'Department of Pediatrics, Mie University, Tsu, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Moriya-Saito', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': ""Department of Hematology Oncology, Children's Medical Center, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.""}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kosaka', 'Affiliation': ""Department of Hematology/Oncology, Hyogo Prefectural Children's Hospital, Kobe, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Hirayama', 'Affiliation': 'Department of Pediatrics, Mie University, Tsu, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iguchi', 'Affiliation': 'Department of Pediatrics, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Hirohide', 'Initials': 'H', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Pediatrics Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Pediatrics, Mie University, Tsu, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': ""Department of Hematology/Oncology, Miyagi Children's Hospital, Sendai, Japan.""}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Kudoh', 'Affiliation': 'Saiseikai Nishiotaru Hospital, Otaru, Japan.'}, {'ForeName': 'Tatsutoshi', 'Initials': 'T', 'LastName': 'Nakahata', 'Affiliation': 'Department of Clinical Application, Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Department of Pediatrics, Okayama University, Okayama, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Hara', 'Affiliation': 'Department of Pediatric Hematology/Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Horibe', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood cancer journal,['10.1038/s41408-020-0287-4']
2217,32664602,Recognition of 16-18-Year-Old Adolescents for Guiding Physical Activity Interventions: A Cross-Sectional Study.,"Adolescence is a rapid life stage requiring special attention wherein personal autonomy is developed to govern independent lifestyles. Unhealthy lifestyles are integral to prevailing adolescent physical inactivity patterns. Understudied 16-18-year-olds were investigated to establish physical activity prevalences and influencing health-related lifestyle factors. Adolescents were recruited randomly across 2017-2019 from Farnborough College of Technology and North Kent College, UK. Demographic and health-related lifestyle information were gathered anonymously and analysed using SAS ®  9.4 software. Among the 414 adolescents included (48.3% male and 51.7% female), the mean (standard deviation (SD)) age was 16.9 (0.77). Approximately 15.2% smoked and 20.8% were overweight/obese. There were 54.8% perceiving themselves unfit and 33.3% spent >4 h/day on leisure-time screen-based activity. Around 80.4% failed to meet the recommended fruit/vegetable daily intake and 90.1% failed to satisfy UK National Physical Activity Guidelines, particularly females ( p  = 0.0202). Physical activity levels were significantly associated with gender, body mass index, smoking status, leisure sedentary screen-time, fruit/vegetable consumption and fitness perceptions. Those who were female, overweight/obese, non-smoking, having poor fitness perceptions, consuming low fruit/vegetables and engaging in excess screen-based sedentariness were the groups with lowest physical activity levels. Steering physical activity-oriented health interventions toward these at-risk groups in colleges may reduce the UK's burden of adolescent obesity.",2020,"Physical activity levels were significantly associated with gender, body mass index, smoking status, leisure sedentary screen-time, fruit/vegetable consumption and fitness perceptions.","['414 adolescents included (48.3% male and 51.7% female), the mean (standard deviation (SD)) age was 16.9 (0.77', 'Adolescents were recruited randomly across 2017-2019 from Farnborough College of Technology and North Kent College, UK', '16-18-Year-Old Adolescents for Guiding Physical Activity Interventions', 'Understudied 16-18-year-olds']",['Steering physical activity-oriented health interventions'],"['body mass index, smoking status, leisure sedentary screen-time, fruit/vegetable consumption and fitness perceptions', 'Physical activity levels']","[{'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517479', 'cui_str': '0.77'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0454861', 'cui_str': 'Kent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0553654', 'cui_str': 'Does steer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0171915,"Physical activity levels were significantly associated with gender, body mass index, smoking status, leisure sedentary screen-time, fruit/vegetable consumption and fitness perceptions.","[{'ForeName': 'Sunbal N', 'Initials': 'SN', 'LastName': 'Bhatti', 'Affiliation': 'School of Biological Sciences, University of Reading, Reading RG6 6AS, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Watkin', 'Affiliation': 'Faculty of Academic Studies, Farnborough College of Technology, Farnborough GU14 6SB, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Butterfill', 'Affiliation': 'Sports Coaching Department, North Kent College, Gravesend, Kent DA12 2JJ, UK.'}, {'ForeName': 'Jian-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'School of Biological Sciences, University of Reading, Reading RG6 6AS, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17145002']
2218,33128593,Standard versus eversion-modified double-staple technique for low colorectal anastomoses after resection of rectal cancer.,"PURPOSE


The double-staple technique, performed as either the standard procedure or after eversion of the rectal stump, is a well-established method of performing low colorectal anastomoses following the resection of rectal cancer. Eversion of the tumor-bearing ano-rectal stump was proposed to allow the linear stapler to be fired at a safe distance of clearance from the tumor. We conducted this study to compare the results of the standard versus the eversion-modified double-staple technique.
METHODS


The subjects of this retrospective study were 753 consecutive patients who underwent low stapled colorectal anastomosis after resection of rectal cancer. The patients were divided into two groups according to the method of anastomosis used: Group A comprised 165 patients (22%) treated with the modified eversion technique and group B comprised 588 patients (78%) treated with the standard technique. The primary endpoints of the study were postoperative mortality, surgery-related morbidity, the number of sampled lymph nodes in the mesorectum, and late disease-related survival.
RESULTS


Postoperative mortality was 1.2% in group A and 1.7% in group B (p = 0.66). Postoperative morbidity was 12% in group A and 11% in group B (p = 0.75). The mean number of sampled lymph nodes in the mesorectum was 23 (range 17-27) in group A and 24 (range 19-29) in group B (p = 0.06). The 5-year disease-related survival was 73% in group A and 74% in group B (p = 0.75).
CONCLUSION


The standard and eversion-modified double-staple techniques yield comparable results.",2020,Postoperative morbidity was 12% in group A and 11% in group B (p = 0.75).,"['753 consecutive patients who underwent low stapled colorectal anastomosis after resection of rectal cancer', 'low colorectal anastomoses after resection of rectal cancer']","['eversion-modified double-staple technique', 'modified eversion technique']","['postoperative mortality, surgery-related morbidity, the number of sampled lymph nodes in the mesorectum, and late disease-related survival', '5-year disease-related survival', 'mean number of sampled lymph nodes', 'Postoperative morbidity', 'Postoperative mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0278307', 'cui_str': 'Coloproctostomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0447562', 'cui_str': 'Mesorectum'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",753.0,0.039285,Postoperative morbidity was 12% in group A and 11% in group B (p = 0.75).,"[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Illuminati', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy. giulio.illuminati@uniroma1.it.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Pasqua', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Perotti', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Urciuoli', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Nardi', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fratini', 'Affiliation': 'The Department of Surgical Sciences, University of Rome ""La Sapienza"", Policlinico Umberto Primo, Viale del Policlinico, 00166, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Carboni', 'Affiliation': 'The Department of Surgical Oncology, Regina Elena Cancer Institute, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valle', 'Affiliation': 'The Department of Surgical Oncology, Regina Elena Cancer Institute, Rome, Italy.'}]",Surgery today,['10.1007/s00595-020-02174-5']
2219,33128709,"Investigation of the Spiritual Care Effects on Anxiety, Depression, Psychological Distress and Spiritual Levels of Turkish Muslim Radiotherapy Patients.","The aim of this study is to examine the spiritual care support given to Muslim cancer patients undergoing radiotherapy with an experimental study on the spirituality, anxiety, depression and distress levels of these patients. In this study, experimental research design with experimental control group was used. Personal information form designed by researchers, HAD scale, DT scale and Spirituality Scale was used for personal information. In conclusion, it was determined that the support for Islamic spiritual care had positive effects on hospitalized radiotherapy patients. According to the results obtained, it is recommended to examine in larger sample groups in different treatment programs in order to reveal the effect of spiritual care support.",2020,"In conclusion, it was determined that the support for Islamic spiritual care had positive effects on hospitalized radiotherapy patients.",['Muslim cancer patients undergoing'],['radiotherapy'],"['spirituality, anxiety, depression and distress levels', 'HAD scale, DT scale and Spirituality Scale', 'Anxiety, Depression, Psychological Distress and Spiritual Levels']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0168586,"In conclusion, it was determined that the support for Islamic spiritual care had positive effects on hospitalized radiotherapy patients.","[{'ForeName': 'Turgay', 'Initials': 'T', 'LastName': 'Şirin', 'Affiliation': 'Islamic Sciences Faculty, Department of Psychology of Religion, Istanbul Sabahattin Zaim University, Halkalı Street, No: 281 Halkalı, Küçükcekmece, Istanbul, 34303, Turkey. turgay.sirin@izu.edu.tr.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Göksel', 'Affiliation': 'Department of Radiation Oncology, SBÜ Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Mehmet Akif Ersoy Street, Yenimahalle, 06200, Ankara, Turkey.'}]",Journal of religion and health,['10.1007/s10943-020-01117-1']
2220,33128722,"Effects of intradialytic cycling exercise on daily physical activity, physical fitness, body composition, and clinical parameters in high-volume online hemodiafiltration patients: a pilot randomized-controlled trial.","PURPOSE


The mortality of dialysis patients treated with high-volume online hemodiafiltration (OL-HDF) is better than hemodialysis, but is still higher than healthy population. Low daily physical activity increases cardiovascular mortality. Addition of intradialytic exercise (IDX) program might improve physical activity and health status in OL-HDF patients. This pilot open-labeled randomized-controlled trial was conducted to evaluate the effects of IDX on physical activity and other clinical parameters in OL-HDF patients.
METHODS


Twelve OL-HDF patients were randomized into control (n = 6) or IDX (n = 6) groups. The subjects in IDX group were trained to exercise using a cycle ergometer for 60 min during each OL-HDF session. Physical activity measured as daily step count using a wrist-worn triaxial accelerometer, physical fitness, or cardiorespiratory fitness assessed by VO 2 max and other physical performance tests, lean body mass determined by the Dual-energy X-ray absorptiometry (DXA), quality of life (QOL), and various parameters were compared between baseline and 6 months.
RESULTS


The baseline physical activity status was comparable. Following 6-month IDX, the physical activity was significantly improved in IDX group [+ 1048.79 (+ 741.50, + 2792.54) vs. - 362.06 (- 1626.82, - 167.47) steps/day, p = 0.01], while physical fitness and QOL were unchanged. The lean body mass parameters were preserved in the IDX group while seemed to decrease in the control group. Serum albumin was significantly increased in the IDX group (p = 0.01). The hemoglobin changes were significantly better (p = 0.01) and the erythropoietin resistance index was significantly lower in the IDX group (p = 0.03). Phosphate reduction was significantly greater in the IDX group (p = 0.04).
CONCLUSIONS


IDX could improve physical activity and other metabolic parameters in OL-HDF patients and these might contribute to further improvement in clinical and survival outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Registration: NCT03353844.",2020,The hemoglobin changes were significantly better (p = 0.01) and the erythropoietin resistance index was significantly lower in the IDX group (p = 0.03).,"['dialysis patients treated with', 'high-volume online hemodiafiltration patients', 'Twelve OL-HDF patients', 'OL-HDF patients']","['high-volume online hemodiafiltration (OL-HDF', 'intradialytic cycling exercise', 'intradialytic exercise (IDX) program', 'IDX']","['baseline physical activity status', 'daily physical activity, physical fitness, body composition, and clinical parameters', 'hemoglobin changes', 'Physical activity measured as daily step count using a wrist-worn triaxial accelerometer, physical fitness, or cardiorespiratory fitness assessed by VO 2 max and other physical performance tests, lean body mass determined by the Dual-energy X-ray absorptiometry (DXA), quality of life (QOL), and various parameters', 'cardiovascular mortality', 'Serum albumin', 'Phosphate reduction', 'physical activity', 'lean body mass parameters', 'erythropoietin resistance index', 'physical fitness and QOL', 'physical activity and health status']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0311641,The hemoglobin changes were significantly better (p = 0.01) and the erythropoietin resistance index was significantly lower in the IDX group (p = 0.03).,"[{'ForeName': 'Nawaporn', 'Initials': 'N', 'LastName': 'Assawasaksakul', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Worawan', 'Initials': 'W', 'LastName': 'Sirichana', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Waraporn', 'Initials': 'W', 'LastName': 'Joosri', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Onanong', 'Initials': 'O', 'LastName': 'Kulaputana', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Sukanya', 'Initials': 'S', 'LastName': 'Eksakulkla', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Chutima', 'Initials': 'C', 'LastName': 'Ketanun', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Maythinee', 'Initials': 'M', 'LastName': 'Chantadisai', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Kullaya', 'Initials': 'K', 'LastName': 'Takkavatakarn', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Paweena', 'Initials': 'P', 'LastName': 'Susantitaphong', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Kearkiat', 'Initials': 'K', 'LastName': 'Praditpornsilpa', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Eiam-Ong', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Khajohn', 'Initials': 'K', 'LastName': 'Tiranathanagul', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand. Khajohn.T@chula.ac.th.'}]",International urology and nephrology,['10.1007/s11255-020-02677-7']
2221,33128725,Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis.,"PURPOSE


To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical studies.
METHODS


Patients with active axSpA from a Phase III, randomized, double-blind, placebo-controlled trial (RAPID-axSpA, NCT01087762) were included (N = 325). Modified New York (mNY) classification criteria were used to classify patients as having ankylosing spondylitis or nr-axSpA; those with nr-axSpA were further categorized based on objective signs of inflammation. Psychometric properties of the ASQoL were assessed/documented using a mixture of modern psychometric methods and classical test theory methods. These included exploratory factor analysis and item response theory models to assess the domain structure, test the utility of a single domain relative to subdomains, assess bias, and generate statistics to guide an empirical scoring algorithm. The reliability and validity of scores were evaluated via internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Score responsiveness was assessed via anchor-based clinically meaningful change, supplemented with empirical cumulative distribution function visualizations.
RESULTS


The ASQoL data were defined by four domains. However, a four-domain solution was found to be inferior to a bifactor solution in which the four domains were included within a total domain. Scoring statistics supported a unit-weighted total score. Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
CONCLUSIONS


Our findings suggest that the ASQoL is an appropriate outcome measure in interventional clinical trials in patients with nr-axSpA.",2020,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
","['patients with non-radiographic axial spondyloarthritis (nr-axSpA', 'patients with nr-axSpA', 'Patients with active axSpA from a Phase III', 'patients with non-radiographic axial spondyloarthritis']","['Modified New York (mNY', 'placebo', 'ASQoL']","['psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale', 'Score responsiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.181763,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
","[{'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Strasse 10, 40789, Monheim am Rhein, Germany. Bengt.Hoepken@ucb.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'Pharmerit International, Bethesda, MD, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'UCB Pharma, Hong Kong, China.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reveille', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02686-0']
2222,33128790,Improvement of oral hypofunction by a comprehensive oral and physical exercise program including textured lunch gatherings.,"BACKGROUND


The deterioration of oral function to a state of oral hypofunction (OHF) is reportedly associated with malnutrition and frailty.
OBJECTIVE


Investigate the association of OHF with physical characteristics and function and test the effects of a program including comprehensive oral and physical exercises and textured lunch gatherings (COPE-TeL program) on oral and physical function in older adults with OHF.
MATERIALS AND METHODS


Eighty-six community-dwelling older adults were randomly assigned into control (n = 43) or intervention (n = 43) groups. The participants were further divided into OHF and normal oral function (NOF) sub-groups based on initial oral examinations. The intervention group participated in the 12-week COPE-TeL program, while the control group performed the physical exercise regimen only. The differences in measured variables for physical and oral function between the OHF and NOF groups were statistically tested, and changes in the proportion of participants with OHF were examined.
RESULTS


Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment. The proportion of participants with OHF was 56% in the intervention group and 67% in the control group before the trial, which became significantly reduced after completing the COPE-TeL program in the intervention group (26%, P = 0.002), but not in the controls (61%, P = 0.549).
CONCLUSION


Older adults with OHF may have diminished physical function. The COPE-TeL program of oral and physical exercises along with textured lunch gatherings may be effective for older adults with OHF.",2020,"RESULTS


Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment.","['older adults with OHF', 'Eighty-six community-dwelling older adults', 'textured lunch gatherings', 'Older adults with OHF']","['comprehensive oral and physical exercises and textured lunch gatherings (COPE-TeL program', 'comprehensive oral and physical exercise program', 'OHF and normal oral function (NOF) sub-groups based on initial oral examinations', 'oral hypofunction (OHF', 'COPE-TeL program, while the control group performed the physical exercise regimen only']","['proportion of participants with OHF', 'physical and oral function', 'hand grip strength and walking speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0039466', 'cui_str': 'Telugu language'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204128', 'cui_str': 'Initial oral examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",86.0,0.0164072,"RESULTS


Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment.","[{'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Norie', 'Initials': 'N', 'LastName': 'Kito', 'Affiliation': 'Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Food Care Co., Ltd.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Izumi', 'Affiliation': 'Food Care Co., Ltd.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Kishima', 'Affiliation': 'Department of Dentistry, Wakakusa Tatsuma Rehabilitation Hospital.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Itoda', 'Affiliation': 'Department of Oral Health Sciences, Osaka Dental University, Faculty of Health Sciences.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': 'Division of Oral and Maxillofacial Biology, Institute for Oral Science, Matsumoto Dental University.'}]",Journal of oral rehabilitation,['10.1111/joor.13122']
2223,33123769,"Branched-chain amino acid metabolism, insulin sensitivity and liver fat response to exercise training in sedentary dysglycaemic and normoglycaemic men.","AIMS/HYPOTHESIS


Obesity and insulin resistance may be associated with elevated plasma concentration of branched-chain amino acids (BCAAs) and impaired BCAA metabolism. However, it is unknown whether the insulin-sensitising effect of long-term exercise can be explained by concomitant change in BCAAs and their metabolism.
METHODS


We included 26 sedentary overweight and normal-weight middle-aged men from the MyoGlu clinical trial, with or without dysglycaemia, for 12 weeks of supervised intensive exercise intervention, including two endurance and two resistance sessions weekly. Insulin sensitivity was measured as the glucose infusion rate (GIR) from a hyperinsulinaemic-euglycaemic clamp. In addition, maximum oxygen uptake, upper and lower body strength and adipose tissue depots (using MRI and spectroscopy) were measured, and subcutaneous white adipose tissue (ScWAT) and skeletal muscle (SkM) biopsies were harvested both before and after the 12 week intervention. In the present study we have measured plasma BCAAs and related metabolites using CG-MS/MS and HPLC-MS/MS, and performed global mRNA-sequencing pathway analysis on ScWAT and SkM.
RESULTS


In MyoGlu, men with dysglycaemia displayed lower GIR, more fat mass and higher liver fat content than normoglycaemic men at baseline, and 12 weeks of exercise increased GIR, improved body composition and reduced liver fat content similarly for both groups. In our current study we observed higher plasma concentrations of BCAAs (14.4%, p = 0.01) and related metabolites, such as 3-hydroxyisobutyrate (19.4%, p = 0.034) in dysglycaemic vs normoglycaemic men at baseline. Baseline plasma BCAA levels correlated negatively to the change in GIR (ρ = -0.41, p = 0.037) and [Formula: see text] (ρ = -0.47, p = 0.015) after 12 weeks of exercise and positively to amounts of intraperitoneal fat (ρ = 0.40, p = 0.044) and liver fat (ρ = 0.58, p = 0.01). However, circulating BCAAs and related metabolites did not respond to 12 weeks of exercise, with the exception of isoleucine, which increased in normoglycaemic men (10 μmol/l, p = 0.01). Pathway analyses of mRNA-sequencing data implied reduced BCAA catabolism in both SkM and ScWAT in men with dysglycaemia compared with men with normoglycaemia at baseline. Gene expression levels related to BCAA metabolism correlated positively with GIR and markers of mitochondrial content in both SkM and ScWAT, and negatively with fat mass generally, and particularly with intraperitoneal fat mass. mRNA-sequencing pathway analysis also implied increased BCAA metabolism after 12 weeks of exercise in both groups and in both tissues, including enhanced expression of the gene encoding branched-chain α-ketoacid dehydrogenase (BCKDH) and reduced expression of the BCKDH phosphatase in both groups and tissues. Gene expression of SLC25A44, which encodes a mitochondrial BCAA transporter, was increased in SkM in both groups, and gene expression of BCKDK, which encodes BCKDH kinase, was reduced in ScWAT in dysglycaemic men. Mediation analyses indicated a pronounced effect of enhanced SkM (~53%, p = 0.022), and a moderate effect of enhanced ScWAT (~18%, p = 0.018) BCAA metabolism on improved insulin sensitivity after 12 weeks of exercise, based on mRNA sequencing. In comparison, plasma concentration of BCAAs did not mediate any effect in this regard.
CONCLUSION/INTERPRETATION


Plasma BCAA concentration was largely unresponsive to long-term exercise and unrelated to exercise-induced insulin sensitivity. On the other hand, the insulin-sensitising effect of long-term exercise in men may be explained by enhanced SkM and, to a lesser degree, also by enhanced ScWAT BCAA catabolism. Graphical abstract.",2020,"mRNA-sequencing pathway analysis also implied increased BCAA metabolism after 12 weeks of exercise in both groups and in both tissues, including enhanced expression of the gene encoding branched-chain α-ketoacid dehydrogenase (BCKDH) and reduced expression of the BCKDH phosphatase in both groups and tissues.","['26 sedentary overweight and normal-weight middle-aged men from the MyoGlu clinical trial, with or without dysglycaemia, for 12\xa0weeks of', 'sedentary dysglycaemic and normoglycaemic men']","['supervised intensive exercise intervention, including two endurance and two resistance sessions weekly', 'exercise training']","['BCAA catabolism', 'circulating BCAAs and related metabolites', 'enhanced SkM', 'BCAA metabolism', 'enhanced expression of the gene encoding branched-chain α-ketoacid dehydrogenase (BCKDH) and reduced expression of the BCKDH phosphatase', 'Baseline plasma BCAA levels', 'GIR, improved body composition and reduced liver fat content', 'liver fat ', 'plasma concentration of BCAAs', 'glucose infusion rate (GIR', 'maximum oxygen uptake, upper and lower body strength and adipose tissue depots (using MRI and spectroscopy', 'Insulin sensitivity', 'subcutaneous white adipose tissue (ScWAT) and skeletal muscle (SkM) biopsies', 'insulin sensitivity', 'plasma concentrations of BCAAs']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0022618', 'cui_str': 'Ketoacid'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0031678', 'cui_str': 'Phosphoric monoester hydrolase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1704223', 'cui_str': 'White Adipose Tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",26.0,0.0591355,"mRNA-sequencing pathway analysis also implied increased BCAA metabolism after 12 weeks of exercise in both groups and in both tissues, including enhanced expression of the gene encoding branched-chain α-ketoacid dehydrogenase (BCKDH) and reduced expression of the BCKDH phosphatase in both groups and tissues.","[{'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway. sindre.lee@medisin.uio.no.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Torgrim M', 'Initials': 'TM', 'LastName': 'Langleite', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Norheim', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olsen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Drevon', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Diabetologia,['10.1007/s00125-020-05296-0']
2224,33123862,"The effects of left DLPFC tDCS on emotion regulation, biased attention, and emotional reactivity to negative content.","The potentiation of neural activity in lateral prefrontal regions via transcranial direct current stimulation (tDCS) can reduce patterns of biased attention for threat and may facilitate intentional emotion regulation. The current study sought to determine whether left dorsolateral prefrontal cortex tDCS, in combination with intentional down-regulation of emotional responses would reduce negative appraisals of aversive content during emotional regulation (assessed during online tDCS), reduce patterns of biased attention and attention bias variability (assessed offline), and attenuate spontaneous (uninstructed) emotional reactivity to negative content (assessed offline) above tDCS or intentional down-regulation of emotions in isolation. Healthy participants (n = 116) were allocated to one of four experimental conditions involving either active or sham tDCS, combined with an either a down-regulate or maintain emotion regulation task. Attention bias/bias variability was assessed with an attentional probe task, and emotional reactivity was assessed in a negative video viewing task. tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability. However, tDCS did attenuate emotional reactivity. Those receiving active stimulation showed smaller elevations in negative mood in response to viewing aversive video content compared with sham. The present findings are consistent with the potential of left frontal tDCS to attenuate negative emotional reactions to aversive content but provide no support for tDCS enhancement of emotion regulation, nor its impact on attention bias or attention bias variability.",2020,"tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability.",['Healthy participants (n = 116'],"['tDCS', 'active or sham tDCS, combined with an either a down-regulate or maintain emotion regulation task', 'transcranial direct current stimulation (tDCS', 'left DLPFC tDCS']","['emotional reactivity', 'emotion regulation, biased attention, and emotional reactivity', 'patterns of biased attention and attention bias variability (assessed offline), and attenuate spontaneous (uninstructed) emotional reactivity to negative content (assessed offline) above tDCS or intentional down-regulation of emotions in isolation', 'attentional probe task, and emotional reactivity', 'appraisals of negative stimuli during emotion regulation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",116.0,0.0943785,"tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability.","[{'ForeName': 'Patrick J F', 'Initials': 'PJF', 'LastName': 'Clarke', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia. Patrick.Clarke@curtin.edu.au.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Van Bockstaele', 'Affiliation': 'School of Psychology, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Welber', 'Initials': 'W', 'LastName': 'Marinovic', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Howell', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Boyes', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'School of Psychology, University of Western Australia, Crawley, Australia.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00840-2']
2225,33123968,"Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study.","INTRODUCTION


Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation).
METHODS


In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m 2  or placebo before topotecan 1.5 mg/m 2  on days 1-5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy.
RESULTS


Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms.
CONCLUSIONS


Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02514447.",2020,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","['Patients Receiving Topotecan for Small Cell Lung Cancer', 'patients with previously treated extensive-stage small cell lung cancer (ES-SCLC']","['trilaciclib', 'placebo', 'intravenous trilaciclib 240\xa0mg/m 2  or placebo before topotecan 1.5\xa0mg/m 2', 'Myelopreservation with Trilaciclib', 'Placebo']","['occurrence of SN', 'duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN', 'myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy', 'antitumor efficacy', 'anemia', 'safety profile, improved quality of life', 'neutropenia', '3 hematologic adverse events', 'Antitumor efficacy', 'additional neutrophil, red blood cell, and platelet measures', 'grade\u2009≥', 'DSN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}]",,0.542584,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","[{'ForeName': 'Lowell L', 'Initials': 'LL', 'LastName': 'Hart', 'Affiliation': 'Medical Oncology, Florida Cancer Specialists, Fort Myers, FL, USA. lhart@flcancer.com.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zoran G', 'Initials': 'ZG', 'LastName': 'Andric', 'Affiliation': 'Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Department of Medical Oncology and Hematology, Highlands Oncology Group, Rogers, MI, USA.'}, {'ForeName': 'Janakiraman', 'Initials': 'J', 'LastName': 'Subramanian', 'Affiliation': ""Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA.""}, {'ForeName': 'Davorin Z', 'Initials': 'DZ', 'LastName': 'Radosavljevic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Zaric', 'Affiliation': 'Faculty of Medicine, Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Sremska Kamenica, Serbia.'}, {'ForeName': 'Wahid T', 'Initials': 'WT', 'LastName': 'Hanna', 'Affiliation': 'Hematology/Oncology, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Medical Oncology, AZ Klina Brasschaat, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Maen A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Department of Oncology, Florida Cancer Specialists, Leesburg, FL, USA.'}]",Advances in therapy,['10.1007/s12325-020-01538-0']
2226,33123978,Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia.,"Essential thrombocythaemia (ET) is a rare myeloproliferative neoplasm. This multicentre, Phase 3b, randomised, open-label, non-inferiority study investigated the cardiac safety, efficacy and tolerability of first-line treatment with anagrelide or hydroxyurea in high-risk ET patients for up to 3 years. Eligible patients aged ≥ 18 years with a diagnosis of high-risk ET confirmed by bone marrow biopsy within 6 months of randomisation received anagrelide (n = 75) or hydroxyurea (n = 74), administered twice daily. Treatment dose for either compound was titrated to the lowest dose needed to achieve a response. Planned primary outcome measures were change in left ventricular ejection fraction from baseline over time and platelet count at Month 6. Planned secondary outcome measures were platelet count change from baseline at Months 3 and 36; percentage of patients with complete or partial response; time to complete or partial response; number of patients with thrombohaemorrhagic events; and changes in white blood cell count or red blood cell count over time. Neither treatment altered cardiac function. There were no significant differences in adverse events between treatment groups, and no reports of malignant transformation. The incidence of disease-related thrombotic or haemorrhagic events was numerically higher in anagrelide-treated patients. Both treatments controlled platelet counts at 6 months, with the majority of patients experiencing complete or partial responses. In conclusion, these results suggest that long-term treatment with anagrelide is not associated with adverse effects on cardiac function. This is one of the few studies using left ventricular ejection fraction assessment and central biopsy reading to confirm the diagnosis of ET.Trial registration number: Clinicaltrials.gov NCT00202644.",2020,The incidence of disease-related thrombotic or haemorrhagic events was numerically higher in anagrelide-treated patients.,"['18\xa0years with a diagnosis of high-risk ET confirmed by bone marrow biopsy within 6\xa0months of randomisation received anagrelide (n\u2009=\u200975) or', 'Eligible patients aged\u2009≥', 'high-risk ET patients for up to 3\xa0years']","['anagrelide or hydroxyurea', 'hydroxyurea', 'Anagrelide Hydrochloride versus Hydroxyurea']","['Cardiovascular Safety', 'platelet count change from baseline at Months 3 and 36; percentage of patients with complete or partial response; time to complete or partial response; number of patients with thrombohaemorrhagic events; and changes in white blood cell count or red blood cell count over time', 'change in left ventricular ejection fraction from baseline over time and platelet count', 'incidence of disease-related thrombotic or haemorrhagic events', 'adverse events', 'cardiac function', 'cardiac safety, efficacy and tolerability']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040028', 'cui_str': 'Essential thrombocythemia'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005954', 'cui_str': 'Bone marrow sampling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0051809', 'cui_str': 'anagrelide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0051809', 'cui_str': 'anagrelide'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0771907', 'cui_str': 'Anagrelide hydrochloride'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.101411,The incidence of disease-related thrombotic or haemorrhagic events was numerically higher in anagrelide-treated patients.,"[{'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Gotic', 'Affiliation': 'Clinic for Hematology Clinical Centre of Serbia Belgrade, Medical Faculty, University of Belgrade, Koste Todorovica 2, 11000, Belgrade, Serbia. miragotic@yahoo.com.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, 7400, Hungary.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Gercheva', 'Affiliation': 'Clinic of Hematology, University Hospital St. Marina, 9010, Varna, Bulgaria.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Warzocha', 'Affiliation': 'Institute of Hematology and Transfusion Medicine, Department of Haematology, 00-791, Warsaw, Poland.'}, {'ForeName': 'Hans Michael', 'Initials': 'HM', 'LastName': 'Kvasnicka', 'Affiliation': 'Institute of Pathology, University Clinic Wuppertal, University of Witten / Herdecke, Wuppertal, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Achenbach', 'Affiliation': 'Research & Development, Shire International GmbH (a Member of the Takeda Group of Companies), 6300, Zug, Switzerland.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Research & Development, Shire (a Member of the Takeda Group of Companies), Lexington, MA, 02421, USA.'}]",Cardiovascular toxicology,['10.1007/s12012-020-09615-0']
2227,32812051,The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19.,"OBJECTIVES


Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19.
METHODS


Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT-PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality.
RESULTS


Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04-0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1-12.1, P < 0.01).
CONCLUSIONS


Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.",2020,"The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04-0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1-12.1, P < 0.01).
","['patients with severe COVID-19', 'Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm', 'Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT-PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included', 'treating patients with COVID-19']","['ribavirin', 'lopinavir/ritonavir and single-dose hydroxychloroquine', 'sofosbuvir/daclatasvir or ribavirin', 'ribavirin and the other receiving sofosbuvir/daclatasvir']","['time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality', 'median duration of stay', 'relative risk of death', 'mortality', 'number needed to treat for benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",,0.0542215,"The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04-0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1-12.1, P < 0.01).
","[{'ForeName': 'Gholamali', 'Initials': 'G', 'LastName': 'Eslami', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Mousaviasl', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Radmanesh', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jelvay', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Bitaraf', 'Affiliation': 'Department of Epidemiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Global Health New Zealand, New Zealand.'}, {'ForeName': 'Shokrollah', 'Initials': 'S', 'LastName': 'Salmanzadeh', 'Affiliation': 'Infectious and Tropical Diseases Research Centre, Ahwaz Jundishapur University of Medical Sciences, Ahwaz, Iran.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Esmaeilian', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mobarak', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tabibi', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Amir Hosein', 'Initials': 'AH', 'LastName': 'Jafari Kashi', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Lotfi', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Seyed Mehdi', 'Initials': 'SM', 'LastName': 'Talebzadeh', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Aseni', 'Initials': 'A', 'LastName': 'Wickramatillake', 'Affiliation': 'University of Moratuwa, Moratuwa, Sri Lanka.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Momtazan', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Hajizadeh Farsani', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Marjani', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mobarak', 'Affiliation': 'Abadan Faculty of Medical Sciences, Abadan, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa331']
2228,30923182,Regional differences in rate of FEV 1  decline in COPD: lessons from SUMMIT.,,2019,,[],[],[],[],[],[],,0.0665765,,"[{'ForeName': 'Bartolomé R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA bcelli@copdnet.org.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'Research and Development, GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Dept of Medicine, Clinical Sciences Centre, University of Liverpool, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Statistics and Programming, Veramed Ltd, Twickenham, UK.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research and Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New\xa0York, NY, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'Research and Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, and Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre, Manchester, UK.'}]",The European respiratory journal,['10.1183/13993003.00278-2019']
2229,33125272,Effectiveness of pelvic floor muscle and abdominal training in women with stress urinary incontinence.,"The aim of this study was to investigate the effectiveness of pelvic floor muscle training and abdominal training in women with stress urinary incontinence. The study included 64 female patients (aged 18 to 49 years) with stress urinary incontinence. Patients were randomly allocated into the pelvic floor muscle training (PFMT) or pelvic floor muscle plus abdominal training (PFMT+AT) groups. Clinical data included stress test results, pelvic floor activity measurements, and Urinary Distress Inventory, and Incontinence Impact Questionnaire responses. The increase in the pelvic floor muscle activity (from the 0th to the 4th week, from the 4th to the 8th week, and from the 0th to the 8th week) was significantly greater for the PFMT+AT group than for the PFMT group ( p  < 0.05). The negativity rate of the stress test at the 4th week was significantly higher for the PFMT+AT group (93.7%) than for the PFMT group (53.1%) (p < 0.001). Women with stress urinary incontinence benefit more from pelvic floor muscle training plus abdominal training than from pelvic floor muscle training alone in terms of increasing their pelvic floor muscle activity and quality of life, and they also experience an earlier recovery.",2020,The negativity rate of the stress test at the 4th week was significantly higher for the PFMT+AT group (93.7%) than for the PFMT group (53.1%) (p < 0.001).,"['women with stress urinary incontinence', '64 female patients (aged 18 to 49\xa0years) with stress urinary incontinence', 'Women with stress urinary incontinence']","['pelvic floor muscle and abdominal training', 'PFMT+AT', 'PFMT', 'pelvic floor muscle training (PFMT) or pelvic floor muscle plus abdominal training (PFMT+AT', 'pelvic floor muscle training plus abdominal training', 'pelvic floor muscle training and abdominal training']","['pelvic floor muscle activity', 'negativity rate of the stress test', 'pelvic floor muscle activity and quality of life', 'stress test results, pelvic floor activity measurements, and Urinary Distress Inventory, and Incontinence Impact Questionnaire responses']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0194386,The negativity rate of the stress test at the 4th week was significantly higher for the PFMT+AT group (93.7%) than for the PFMT group (53.1%) (p < 0.001).,"[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Kucukkaya', 'Affiliation': 'Health Science Faculty, Department of Women Health and Gynecologic Nursing, Trakya University , Edirne, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Kahyaoglu Sut', 'Affiliation': 'Health Science Faculty, Department of Women Health and Gynecologic Nursing, Trakya University , Edirne, Turkey.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1842470']
2230,33125362,Effect of Whole-Brain and Intensity-Modulated Radiotherapy on Serum Levels of miR-21 and Prognosis for Lung Cancer Metastatic to the Brain.,"BACKGROUND The goal of the present study was to explore the influence of whole-brain radiotherapy (WBRT) and intensity-modulated radiotherapy (IMRT) on serum levels of miR-21 and prognosis for lung cancer that has metastasized to the brain. MATERIAL AND METHODS Two hundred patients with lung cancer metastatic to the brain were randomized, half to the control group and half to the observation group. The observation group received WBRT and reduced-field IMRT (WBRT+RF-IMRT) and the control group received conventional-field IMRT (CF-IMRT). The total effective rate after treatment was determined. Serum levels of miR-21 were measured before and after radiotherapy with reverse transcriptase-polymerase chain reaction. In addition, tumor marker levels were measured with enzyme-linked immunosorbent assay. The relationship between miR-21 levels and tumor marker levels was assessed with a Pearson correlation coefficient test. Five-year survival was estimated with Kaplan-Meier curves. RESULTS The total effective rate was higher in the observation group (86%) than in the control group (69%). Lower levels of miR-21 and tumor markers were seen in the observation group. Moreover, miR-21 levels were positively correlated with levels of tumor necrosis factor-a, neuron-specific enolase, SCC-Ag, and carcinoembryonic antigen. Low levels of miR-21 were associated with longer overall survival in patients with lung cancer metastatic to the brain. CONCLUSIONS WBRT+RF-IMRT is superior to CF-IMRT for lung cancer metastatic to the brain. MiR-21 may be a marker for prediction of the efficacy of radiotherapy in this disease setting.",2020,The total effective rate was higher in the observation group (86%) than in the control group (69%).,"['patients with lung cancer metastatic to the brain', 'Two hundred patients with lung cancer metastatic to the brain', 'Lung Cancer Metastatic to the Brain']","['conventional-field IMRT (CF-IMRT', 'WBRT+RF-IMRT', 'Whole-Brain and Intensity-Modulated Radiotherapy', 'whole-brain radiotherapy (WBRT) and intensity-modulated radiotherapy (IMRT', 'radiotherapy', 'WBRT and reduced-field IMRT (WBRT+RF-IMRT']","['Serum levels of miR-21', 'total effective rate', 'miR-21 levels', 'levels of tumor necrosis factor-a, neuron-specific enolase, SCC-Ag, and carcinoembryonic antigen', 'tumor marker levels', 'Lower levels of miR-21 and tumor markers', 'miR-21 levels and tumor marker levels', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0075091', 'cui_str': 'Squamous cell carcinoma antigen'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0474700', 'cui_str': 'Tumor marker measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.0544242,The total effective rate was higher in the observation group (86%) than in the control group (69%).,"[{'ForeName': 'Zhensheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Qiurong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Lung Disease Division, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Mingjuan', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Jinan People's Hospital, Jinan, Shandong, China (mainland).""}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Department of Oncology, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924640']
2231,33125390,"Caregiver experience and perceived acceptability of a novel near point-of-care early infant HIV diagnostic test among caregivers enrolled in the PMTCT program, Myanmar: A qualitative study.","BACKGROUND


The majority of HIV infection among children occurs through mother-to-child transmission. HIV exposed infants are recommended to have virological testing at birth or 4-6 weeks of age but challenges with centralized laboratory-based testing in Myanmar result in low testing rates and delays in result communication and treatment initiation. Decentralized point-of-care (POC) testing when integrated in prevention of mother-to-child transmission of HIV (PMTCT) services, can be an alternative to increase coverage of early infant diagnosis (EID) and timely engagement in HIV treatment and care.
AIM


This paper aims to explore experiences of caregivers of HIV-exposed infants enrolled in the PMTCT program in Myanmar and the perceived acceptability of point-of-care EID testing compared to conventional centralised laboratory-based testing.
METHODS


This is a sub-study of the cluster randomised controlled stepped-wedge trial (Trial registration number: ACTRN12616000734460) that assessed the impact of near POC EID testing using Xpert HIV-1 Qual assay in four public hospitals in Myanmar. Caregivers of infants who were enrolled in the intervention phase of the main study, had been tested with both Xpert and standard of care tests and had received the results were eligible for this qualitative study. Semi-structured interviews were conducted with 23 caregivers. Interviews were audio recorded, transcribed verbatim and translated into English. Thematic data analysis was undertaken using NVivo 12 Software (QSR International).
RESULTS


The majority of caregivers were satisfied with the quality of care provided by PMTCT services. However, they encountered social and financial access barriers to attend the PMTCT clinic regularly. Mothers had concerns about community stigma from the disclosure of their HIV status and the potential consequences for their infants. While medical care at the PMTCT clinics was free, caregivers sometimes experienced financial difficulties associated with out-of-pocket expenses for childbirth and transportation. Some caregivers had to choose not to attend work (impacting their income) or the adult antiretroviral clinic in order to attend the paediatric PMTCT clinic appointment. The acceptability of the Xpert testing process was high among the caregiver participants and more than half received the Xpert result on the same day as testing. Short turnaround time of the near POC EID testing enabled the caregivers to find out their infants' HIV status quicker, thereby shortening the stressful waiting time for results.
CONCLUSION


Our study identified important access challenges facing caregivers of HIV exposed infants and high acceptability of near POC EID testing. Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.",2020,"Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.","['caregivers of HIV-exposed infants enrolled in the PMTCT program in Myanmar', 'caregivers enrolled in the PMTCT program, Myanmar', 'four public hospitals in Myanmar', 'Caregivers of infants who were enrolled in the intervention phase of the main study, had been tested with both Xpert and standard of care tests and had received the results were eligible for this qualitative study']","['Decentralized point-of-care (POC', 'conventional centralised laboratory-based testing']","['stressful waiting time', 'retention rate']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0683998,"Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.","[{'ForeName': 'Win Lei', 'Initials': 'WL', 'LastName': 'Yee', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Kyu Kyu', 'Initials': 'KK', 'LastName': 'Than', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Hla', 'Initials': 'H', 'LastName': 'Htay', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Tin', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Thein', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Latt Latt', 'Initials': 'LL', 'LastName': 'Kyaw', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Win Win', 'Initials': 'WW', 'LastName': 'Yee', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Moe Myat', 'Initials': 'MM', 'LastName': 'Aye', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Badman', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kelly-Hanku', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0241245']
2232,33125399,Effects of music therapy as an adjunct to chest physiotherapy in children with cystic fibrosis: A randomized controlled trial.,"Airway clearance therapy (ACT) is considered an important approach to improve airway clearance in children with cystic fibrosis (CF). Daily ACT administration requires substantial commitments of time and energy that complicate ACT and reduce its benefits. It is crucial to establish ACT as a positive routine. Music therapy (MT) is an aspect of integrative strategies to ameliorate the psycho-emotional consequences of chronic diseases, and a MT intervention could help children with CF between the ages of 2 and 17 develop a positive response. The aim of this randomized controlled trial was to evaluate the effects of specifically composed and recorded instrumental music as an adjunct to ACT. We compared the use of specifically composed music (Treated Group, TG), music that the patient liked (Placebo Group, PG), and no music (Control Group, CG) during the usual ACT routine in children with CF aged from 2 to 17. The primary outcomes, i.e., enjoyment and perception of time, were evaluated via validated questionnaires. The secondary outcome, i.e., efficiency, was evaluated in terms of avoided healthcare resources. Enjoyment increased after the use of the specifically composed music (children +0.9 units/parents +1.7 units; p<0.05) compared to enjoyment with no music (0 units) and familiar music (+0.5 units). Perception of time was 11.1 min (±3.9) less than the actual time in the TG (p<0.05), 3.9 min (±4.2) more than the actual time in the PG and unchanged in the CG. The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG. In conclusion, the specifically composed, played and compiled instrumental recorded music is an effective adjunct to ACT to establish a positive response and is an efficient option in terms of avoided costs. Trial registered as ISRCTN11161411. ISRCTN registry (www.isrctn.com).",2020,"The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG.","['children with cystic fibrosis', 'children with CF aged from 2 to 17', 'children with cystic fibrosis (CF']","['music therapy', 'Airway clearance therapy (ACT', 'Music therapy (MT', 'specifically composed music (Treated Group, TG), music that the patient liked (Placebo Group, PG), and no music (Control Group, CG']","['Perception of time', 'enjoyment and perception of time', 'Enjoyment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",,0.0895695,"The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Montero-Ruiz', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fuentes', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Pérez Ruiz', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'García-Agua Soler', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Rius-Diaz', 'Affiliation': 'Departamento de Medicina Preventiva y Salud Pública, Universidad de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Caro Aguilera', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez Frías', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Martín-Montañez', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}]",PloS one,['10.1371/journal.pone.0241334']
2233,33125405,Factors influencing the bias between blood gas analysis versus central laboratory hemoglobin testing. A secondary analysis of a randomized controlled trial.,"BACKGROUND


Anemia is the most important complication during major surgery and transfusion of red blood cells is the mainstay to compensate for life threating blood loss. Therefore, accurate measurement of hemoglobin (Hb) concentration should be provided in real-time. Blood Gas Analysis (BGA) provides rapid point-of-care assessment using smaller sampling tubes compared to central laboratory (CL) services.
OBJECTIVE


This study aimed to investigate the accuracy of BGA hemoglobin testing as compared to CL services.
METHODS


Data of the ongoing LIBERAL-Trial (Liberal transfusion strategy to prevent mortality and anemia-associated ischemic events in elderly non-cardiac surgical patients, LIBERAL) was used to assess the bias for Hb level measured by BGA devices (ABL800 Flex analyzer®, GEM series® and RapidPoint 500®) and CL as the reference method. For that, we analyzed pairs of Hb level measured by CL and BGA within two hours. Furthermore, the impact of various confounding factors including age, gender, BMI, smoker status, transfusion of RBC, intraoperative hemodilution, and co-medication was elucidated. In order to ensure adequate statistical analysis, only data of participating centers providing more than 200 Hb pairs were used.
RESULTS


In total, three centers including 963 patients with 1,814 pairs of Hb measurements were analyzed. Mean bias was comparable between ABL800 Flex analyzer® and GEM series®: - 0.38 ± 0.15 g/dl whereas RapidPoint 500® showed a smaller bias (-0.09 g/dl) but greater median absolute deviation (± 0.45 g/dl). In order to avoid interference with different standard deviations caused by the different analytic devices, we focused on two centers using the same BGA technique (309 patients and 1,570 Hb pairs). A Bland-Altman analysis and LOWESS curve showed that bias decreased with smaller Hb values in absolute numbers but increased relatively. The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias. Intraoperative substitution of volume and other co-medications did not influence the bias significantly.
CONCLUSION


Many interventions like substitution of fluids, coagulating factors or RBC units rely on the accuracy of laboratory measurement devices. Although BGA Hb testing showed a consistently stable difference to CL, our data confirm that BGA devices are associated with different bias. Therefore, we suggest that hospitals assess their individual bias before implementing BGA as valid and stable supplement to CL. However, based on the finding that bias decreased with smaller Hb values, which in turn are used for transfusion decision, we expect no unnecessary or delayed RBC transfusion, and no major impact on the LIBERAL trial performance.",2020,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","['963 patients with 1,814 pairs of Hb measurements', '309 patients and 1,570 Hb pairs', 'elderly non-cardiac surgical patients, LIBERAL']",['BGA technique'],"['mortality and anemia-associated ischemic events', 'Mean bias', 'BMI', 'RBC transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",963.0,0.0950543,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tanner', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lindau', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Velten', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wittmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Berg', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Piekarski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Füllenbach', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Choorapoikayil', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Medical Faculty of the University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0240721']
2234,33125420,A comparison of endoscopic and microscopic inlay butterfly cartilage tympanoplasties and their educational utility.,"OBJECTIVES


Inlay butterfly cartilage tympanoplasty (IBCT) is a simple grafting technique. Endoscopy facilitates visualization by eliminating blind spots. We analyzed the outcomes of IBCT using both endoscopic and microscopic approaches, and assessed how trainees perceived the educational opportunities afforded.
MATERIALS AND METHODS


Sixty patients who underwent IBCT were allocated to Group I (n = 30; microscopic IBCT) and Group II (n = 30; endoscopic IBCT) by the dates of their visits. Anatomical success was defined as an intact, repaired tympanic membrane; functional success was defined as a significant decrease in the air-bone gap. Postoperative discomfort was analyzed using a visual analog scale (VAS). Thirteen trainees completed structured questionnaires exploring anatomical identification and the surgical steps.
RESULTS


The surgical success rates were 96.7% in Group I and 100% in Group II. We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort. Significant postoperative hearing improvements were evident in both groups. The mean operative time was shorter when the microscopic approach was chosen (17.7±4.53 vs. 26.13±9.94 min). The two approaches significantly differed in terms of the identification of external and middle ear anatomical features by the trainees, and their understanding of the surgical steps.
CONCLUSION


Both endoscopic and microscopic IBCT were associated with good success rates. The endoscopic approach facilitates visualization, and a better understanding of the middle ear anatomy and the required surgical steps and thus is of greater educational utility.",2020,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,['Sixty patients who underwent'],"['Inlay butterfly cartilage tympanoplasty (IBCT', 'IBCT', 'endoscopic IBCT', 'microscopic IBCT']","['Significant postoperative hearing improvements', 'mean operative time', 'Postoperative discomfort', 'surgical success rates', 'visual analog scale (VAS', 'Anatomical success', 'identification of external and middle ear anatomical features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",60.0,0.0269257,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,"[{'ForeName': 'Noor Dina', 'Initials': 'ND', 'LastName': 'Hashim', 'Affiliation': 'Department of Otorhinolaryngology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Se A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University School of Medicine, Bucheon, Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Jang', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Moon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0241152']
2235,33125448,Comparative effectiveness clinical trial of magnetic seizure therapy and electroconvulsive therapy in major depressive disorder.,"BACKGROUND


Magnetic seizure therapy (MST) has demonstrated fewer cognitive side effects than electroconvulsive therapy (ECT) in antidepressant efficacy trials. However, there are no effectiveness trials examining antidepressant efficacy and cognitive side effects against ECT. The aims of this study were to evaluate the comparative effectiveness of MST vs ECT in major depressive disorder (MDD), and compare the cognitive side effects of MST and ECT.
METHODS


In this open-label study, patients were assigned to either ECT or high-dose MST twice a week for 5 sessions based on the clinician's and the patient's decision-making. Efficacy was primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); cognitive side effects were assessed by time to reorientation (TRO) and cognitive battery.
RESULTS


Sixty patients were enrolled. Efficacy was similar between those assigned to MST (n = 30) and ECT (n = 30). Post-treatment HAMD-21 mean scores were 12.33 after MST, 12.80 after bitemporal (BT) ECT (n = 15), and 27.93 after right unilateral (RUL) ECT (n = 15). Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
CONCLUSIONS


Magnetic seizure therapy was effective for the treatment of MDD in real-world clinical care, with fewer cognitive side effects than ECT. Future studies are warranted to replicate these findings.",2020,"Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
","['major depressive disorder', 'Sixty patients were enrolled', 'major depressive disorder (MDD']","['Magnetic seizure therapy', 'ECT', 'bitemporal (BT) ECT', 'Magnetic seizure therapy (MST', 'ECT or high-dose MST', 'MST vs ECT', 'MST', 'magnetic seizure therapy and electroconvulsive therapy', 'electroconvulsive therapy (ECT']","['faster TRO', 'cognitive side effects', 'Efficacy', 'time to reorientation (TRO) and cognitive battery', 'Hamilton Depression Rating Scale-21 (HAMD-21); cognitive side effects']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",60.0,0.0472004,"Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
","[{'ForeName': 'Fatma A', 'Initials': 'FA', 'LastName': 'El-Deeb', 'Affiliation': ''}, {'ForeName': 'El-Sayed A', 'Initials': 'EA', 'LastName': 'Gad', 'Affiliation': ''}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Kandeel', 'Affiliation': ''}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Haiba', 'Affiliation': ''}, {'ForeName': 'Sameh M', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': ''}, {'ForeName': 'Meghan M', 'Initials': 'MM', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University and Charlie Norwood VA Medical Center, Augusta, Georgia 30912 USA. E-MAIL: nyoussef@augusta.edu.'}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,['10.12788/acp.0005']
2236,33125454,"Double-blind, placebo-controlled, proof-of-concept trial of a kappa-selective opioid receptor antagonist augmentation in treatment-resistant depression.","BACKGROUND


Kappa-opioid antagonism may possess antidepressant properties. We assessed, in a proof-of-concept pilot trial among patients with major depressive disorder with inadequate response to antidepressants, the efficacy of adjunctive CERC-501 (formerly LY2456302), a kappaselective opioid receptor antagonist.
METHODS


In a Sequential Parallel Comparison Design study, patients were pre-randomized to: a) 10 mg/d of CERC-501 for 6 days, b) 20 mg/d of CERC-501 for 6 days, c) placebo for 3 days followed by 10 mg/d of CERC- 501 for 3 days, d) placebo for 3 days followed by 20 mg/d of CERC-501 for 3 days, or e) placebo for 6 days.
RESULTS


The study was terminated early by the National Institute of Mental Health due to slow enrollment (N = 8). The weighted mean difference of changes (drug vs placebo) in the 6-item Hamilton Depression Rating Scale (HAMD-6) (primary outcome measure) (1.28), Montgomery-Åsberg Depression Rating Scale (MADRS) (2.33), Perceived Stress Scale (1.01), Symptoms of Depression Questionnaire (9.17), Positive Affect Scale (PAS) (6.39), Symptom Questionnaire (SQ) Depression scale (2.94), SQ Anger- Hostility scale (1.67), and Patient-Reported Outcomes Measurement Information System Satisfaction with Participation in Discretionary Social Activities (4.67) scores were all numerically but not statistically greater for CERC-501 than for placebo.
CONCLUSIONS


Although the small sample size limits the ability to draw conclusions, results suggest that CERC-501 may have antidepressant effects. Additional studies are necessary to further explore these effects of CERC-501.",2020,"The weighted mean difference of changes (drug vs placebo) in the 6-item Hamilton Depression Rating Scale (HAMD-6) (primary outcome measure) (1.28), Montgomery-Åsberg Depression Rating Scale (MADRS) (2.33), Perceived Stress Scale (1.01), Symptoms of Depression Questionnaire (9.17), Positive Affect Scale (PAS) (","['patients with major depressive disorder with inadequate response to antidepressants, the efficacy of adjunctive CERC-501 (formerly LY2456302), a kappaselective opioid receptor antagonist']","['kappa-selective opioid receptor antagonist augmentation', 'CERC-501', 'placebo']","['Montgomery-Åsberg Depression Rating Scale (MADRS) (2.33), Perceived Stress Scale (1.01), Symptoms of Depression Questionnaire (9.17), Positive Affect Scale (PAS) ', 'Symptom Questionnaire (SQ) Depression scale (2.94), SQ Anger- Hostility scale', 'Outcomes Measurement Information System Satisfaction with Participation in Discretionary Social Activities (4.67) scores', '6-item Hamilton Depression Rating Scale (HAMD-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5198372', 'cui_str': 'CERC-501'}, {'cui': 'C3886583', 'cui_str': 'LY2456302'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C5198372', 'cui_str': 'CERC-501'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",,0.304065,"The weighted mean difference of changes (drug vs placebo) in the 6-item Hamilton Depression Rating Scale (HAMD-6) (primary outcome measure) (1.28), Montgomery-Åsberg Depression Rating Scale (MADRS) (2.33), Perceived Stress Scale (1.01), Symptoms of Depression Questionnaire (9.17), Positive Affect Scale (PAS) (","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA 02114 USA. E-MAIL: mfava@partners.org.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Mazzone', 'Affiliation': ''}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Freeman', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': ''}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Hock', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shui', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': ''}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Carpenter', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajecka', 'Affiliation': ''}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,['10.12788/acp.0003']
2237,33125674,"Safety, Pharmacokinetics, and Pharmacodynamics of Globalagliatin, a Glucokinase Activator, in Chinese Patients with Type 2 Diabetes Mellitus: A Randomized, Phase Ib, 28-day Ascending Dose Study.","BACKGROUND AND OBJECTIVES


Globalagliatin, a glucokinase activator, plays a vital role in glucose homeostasis. The aim of this study was to assess the safety, pharmacokinetics, and pharmacodynamics of globalagliatin in Chinese patients with type 2 diabetes.
METHODS


In this dose-titration study, 24 patients were randomized (3:1 ratio) to receive globalagliatin or placebo. The 28-day titration was divided into two stages, each comprising 12 subjects. In stage I (low-dose), globalagliatin or placebo was administered at ascending doses of 20, 40, 80, and 120 mg once daily, increased at weekly intervals. As the treatment was well tolerated, stage II (high-dose) was initiated, with ascending doses of 80, 160, 240, and 320 mg. Safety, pharmacokinetic and pharmacodynamic analysis were conducted.
RESULTS


Following once-daily titration with ascending doses of globalagliatin of 20-120 mg (stage I) and 80-320 mg (stage II) for 7 days, globalagliatin caused mildly high incidences of hypoglycemia and hypertriglyceridemia. The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ng/mL (stage I), and 29.36 to 471.50 ng/mL (stage II), which occurred at 3-5 h post-dose. A steady state was achieved after 7 days of once-daily dosing in stage I and stage II, respectively. Mean area under the plasma-concentration curve for steady-state 24-h interval (AUC 0-24 ) increased from 106.13 to 2461.95 ng·h/mL (stage I) and 369.71 to 9218.38 ng·h/mL (stage II). Fasting plasma glucose (FPG) decreased continuously during the titration period. Compared with the placebo, high-dose globalagliatin significantly increased the reductions in FPG, the area under the curve of 24-h glucose levels, and glycated albumin, with least-squares mean changes (relative to baseline) of - 4.08 mmol/L (95% CI - 5.05 to - 3.12) (P < 0.01), - 103.93 mmol/L (95% CI - 135.80 to - 72.06) (P < 0.01), and - 4.71% (95% CI - 6.91 to - 2.51) (P < 0.01)), respectively. High-dose globalagliatin significantly increased the Matsuda index, indicating improved insulin resistance.
CONCLUSIONS


Globalagliatin was well tolerated and showed favorable pharmacokinetic profiles in Chinese patients with type 2 diabetes. High-dose globalagliatin reduced plasma glucose, and improved insulin resistance.
TRIAL REGISTRATION


Clinicaltrials.gov indentifier, NCT03414892.",2020,The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ,"['Chinese Patients with Type 2 Diabetes Mellitus', '24 patients were randomized (3:1 ratio) to receive', 'Chinese patients with type 2 diabetes']","['globalagliatin or placebo', 'placebo']","['hypoglycemia and hypertriglyceridemia', 'plasma glucose, and improved insulin resistance', 'Mean area under the plasma-concentration curve', 'mean maximum plasma concentration (C max ) of globalagliatin', 'Fasting plasma glucose (FPG', 'Safety, Pharmacokinetics, and Pharmacodynamics of Globalagliatin', 'reductions in FPG, the area under the curve of 24-h glucose levels, and glycated albumin', 'insulin resistance', 'safety, pharmacokinetics, and pharmacodynamics of globalagliatin', 'Matsuda index']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",24.0,0.433775,The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ,"[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Sufeng', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Suzhou Yabao Pharmaceutical R&D Co., Ltd., Suzhou, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Suzhou Yabao Pharmaceutical R&D Co., Ltd., Suzhou, Jiangsu, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. zhengxuqin@njmu.edu.cn.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. yangt@njmu.edu.cn.'}]",Clinical drug investigation,['10.1007/s40261-020-00971-x']
2238,33125702,Effect of oral tranexamic acid on erythema index in patients with melasma.,"Melasma is a common disorder of hyperpigmentation that presents a therapeutic challenge for clinical dermatologists. The pathogenesis is complex, but previous studies have demonstrated vascular proliferation is a key factor in the development of the classic hyperpigmented patches. Studies have revealed reduction of erythema by oral tranexamic acid; however, there has been no direct comparison to placebo. This 24-week randomised placebo-controlled trial demonstrates oral tranexamic acid may improve erythema in melasma. This mechanism of action may be the reason for the success of tranexamic acid in complex and difficult to treat melasma.",2020,This 24-week randomised placebo-controlled trial demonstrates oral tranexamic acid may improve erythema in melasma.,['patients with melasma'],"['placebo', 'tranexamic acid', 'oral tranexamic acid']",['erythema index'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.153329,This 24-week randomised placebo-controlled trial demonstrates oral tranexamic acid may improve erythema in melasma.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Victorian Melanoma Service, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Harini', 'Initials': 'H', 'LastName': 'Rajgopal Bala', 'Affiliation': 'Department of Dermatology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'Emergency Department, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Celestine C', 'Initials': 'CC', 'LastName': 'Wong', 'Affiliation': 'Chroma Dermatology, Pigment and Skin of Colour Centre, Wheelers Hill, Victoria, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Chroma Dermatology, Pigment and Skin of Colour Centre, Wheelers Hill, Victoria, Australia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13482']
2239,33125753,"Endothelial-protective effects of a G-protein-biased S1P 1  agonist, SAR247799, in type-2 diabetes rats and a randomized placebo-controlled patient trial.","AIM


SAR247799 is a G-protein-biased sphingosine-1 phosphate receptor-1 (S1P 1  ) agonist designed to activate endothelial S1P 1  and provide endothelial-protective properties, while limiting S1P 1  desensitization and consequent lymphocyte-count reduction associated with higher doses. The aim was to show whether S1P 1  activation can promote endothelial effects in patients and, if so, select SAR247799 doses for further clinical investigation.
METHODS


Type-2 diabetes patients, enriched for endothelial dysfunction (flow-mediated dilation, FMD<7%) (n=54), were randomized, in two sequential cohorts, to 28-day once-daily treatment with SAR247799 (1 or 5 mg in ascending cohorts), placebo or 50 mg sildenafil (positive control) in a 5:2:2 ratio per cohort. Endothelial function was assessed by brachial artery FMD. Renal function, biomarkers and lymphocytes were measured following 5-week SAR247799 treatment (three doses) to zucker-diabetic-fatty rats and the data used to select the doses for human testing.
RESULTS


The maximum FMD change from baseline versus placebo for all treatments was reached on day-35; mean differences versus placebo were 0.60% (95% CI -0.34%-1.53%; p=0.203) for 1 mg SAR247799, 1.07% (95% CI 0.13%-2.01%; p=0.026) for 5 mg SAR247799 and 0.88% (95% CI -0.15%-1.91%; p=0.093) for 50 mg sildenafil. Both doses of SAR247799 were well tolerated, did not affect blood pressure, and were associated with minimal-to-no lymphocyte reduction and small-to-moderate heart rate decrease.
CONCLUSION


These data provide the first human evidence suggesting endothelial-protective properties of S1P 1  activation, with SAR247799 being as effective as the clinical benchmark, sildenafil. Further clinical testing of SAR247799, at sub-lymphocyte-reducing doses (≤5 mg), is warranted in vascular diseases associated with endothelial dysfunction.",2020,"The maximum FMD change from baseline versus placebo for all treatments was reached on day-35; mean differences versus placebo were 0.60% (95% CI -0.34%-1.53%; p=0.203) for 1 mg SAR247799, 1.07% (95% CI 0.13%-2.01%; p=0.026) for 5 mg SAR247799 and 0.88% (95% CI -0.15%-1.91%; p=0.093) for 50 mg sildenafil.","['type-2 diabetes rats', 'Type-2 diabetes patients, enriched for endothelial dysfunction (flow-mediated dilation, FMD<7%) (n=54']","['SAR247799', 'G-protein-biased S1P 1  agonist, SAR247799', 'sildenafil', 'placebo', 'placebo or 50 mg sildenafil (positive control']","['Renal function, biomarkers and lymphocytes', 'blood pressure', 'Endothelial function', 'tolerated', 'maximum FMD change']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]","[{'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0390526', 'cui_str': 'Receptor, Sphingosine-1-Phosphate'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.286678,"The maximum FMD change from baseline versus placebo for all treatments was reached on day-35; mean differences versus placebo were 0.60% (95% CI -0.34%-1.53%; p=0.203) for 1 mg SAR247799, 1.07% (95% CI 0.13%-2.01%; p=0.026) for 5 mg SAR247799 and 0.88% (95% CI -0.15%-1.91%; p=0.093) for 50 mg sildenafil.","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bergougnan', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Evaristi', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Poirier', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tardat', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ermer', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Herbrand', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arrubla', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Hans Veit', 'Initials': 'HV', 'LastName': 'Coester', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sansone', 'Affiliation': 'University Hospital Düsseldorf, Division of Cardiology, Pulmonary diseases and Vascular medicine, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heiss', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Surrey, Stag Hill, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vitse', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Hurbin', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Boiron', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Benain', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radzik', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Janiak', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Muslin', 'Affiliation': 'Sanofi US Services, 640 Memorial Drive, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Hovsepian', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Kirkesseli', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deutsch', 'Affiliation': 'Sanofi US Services, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.'}, {'ForeName': 'Ashfaq A', 'Initials': 'AA', 'LastName': 'Parkar', 'Affiliation': 'Sanofi US Services, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14632']
2240,33125769,Effects of Parathyroidectomy on Quality of Life: 10 years Data from a Prospective Randomized Controlled Trial on Primary Hyperparathyroidism (the SIPH-study).,"Primary hyperparathyroidism (PHPT) was previously considered a disease presenting with multi-organ involvement and a wide range of symptoms. Today, the disease presents with no symptoms or mild symptomatology in most patients. Data regarding non-specific symptoms such as pain, fatigue, memory loss, depression and other neuropsychiatric signs have been ambiguous and results from prospective long-term randomized control trials are lacking. The Scandinavian Investigation on Primary Hyperparathyroidism (SIPH) is a prospective randomized controlled trial (RCT) with 10-year follow up, comparing parathyroidectomy (PTX) to observation without any treatment (OBS). From 1998 to 2005, 191 patients with mild PHPT were included from Sweden, Norway and Denmark. 95 patients were randomized to PTX and 96 to OBS. The generic Short Form-36 survey (SF-36) and the Comprehensive Psychopathological Rating Scale (CPRS) were studied at baseline, 2, 5 and 10 years after randomization. After 10 years, the PTX group scored significantly better on vitality (PTX: 65.1± 20.2 vs. OBS: 57.4 ± 22.7; p=0.017) compared to OBS group in SF-36. We found no differences between the groups in the physical subscales. The OBS group had no significant change in any of the SF-36 scores throughout the study. The CPRS showed an improvement of symptoms in both groups for single items and sum scores after 10 years compared to baseline. There were, however, no significant differences between the two groups in the CPRS-data. The results of this large and long term RCT indicate improvement in some of the mental domains of SF-36 following PTX. However, the treatment effects between the groups were subtle with uncertain clinical significance. The observation group had stable SF-36 values and improvement in CPRS symptom-scores. Thus, in considering only QoL and in the absence of declines in renal and skeletal parameters, it may be safe to observe patients with mild PHPT for a decade. This article is protected by copyright. All rights reserved.",2020,The CPRS showed an improvement of symptoms in both groups for single items and sum scores after 10 years compared to baseline.,"['From 1998 to 2005, 191 patients with mild PHPT were included from Sweden, Norway and Denmark', '95 patients']","['PTX', 'parathyroidectomy (PTX', 'Parathyroidectomy']","['stable SF-36 values', 'Quality of Life', 'CPRS symptom-scores', 'generic Short Form-36 survey (SF-36) and the Comprehensive Psychopathological Rating Scale (CPRS', 'SF-36 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",95.0,0.0730795,The CPRS showed an improvement of symptoms in both groups for single items and sum scores after 10 years compared to baseline.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pretorius', 'Affiliation': 'Section of Specialized Endocrinology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Lundstam', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Radiology, Institute of clinical sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Morten W', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Godang', 'Affiliation': 'Section of Specialized Endocrinology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Mollerup', 'Affiliation': 'Clinic of Breast and Endocrine Surgery, Center HOC, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Stine L', 'Initials': 'SL', 'LastName': 'Fougner', 'Affiliation': 'Department of Endocrinology, Clinic of Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Pernow', 'Affiliation': 'Department of Molecular Medicine and Surgery, Department of Endocrinology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Turid', 'Initials': 'T', 'LastName': 'Aas', 'Affiliation': 'Department of Breast and Endocrine Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Hessman', 'Affiliation': 'Department of Surgery, Västmanland County Hospital, Västerås, Sweden.'}, {'ForeName': 'Thord', 'Initials': 'T', 'LastName': 'Rosén', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes, and Metabolism, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Nordenström', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Jansson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Heck', 'Affiliation': 'Section of Specialized Endocrinology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bollerslev', 'Affiliation': 'Section of Specialized Endocrinology, Oslo University Hospital, Oslo, Norway.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4199']
2241,33125782,Dietary L-carnitine affects the expression of genes involved in apoptosis and fatty acid metabolism in rooster testes.,"Thirty-six 12-week-old breeder roosters (Ross 308) were randomly allocated into three groups to receive L-carnitine (LC): LC-0, LC-250 or LC-500 mg/kg of diet to evaluate the effects of dietary LC on the expression of apoptotic-related genes and desaturases and elongase mRNA transcript levels, in the cockerel testicles. Alteration of Bak (Bcl2 antagonist/killer), Bcl2, Cas3, Cas8, Cas9, Elovl2, Elovl4, Elovl5, Fads1, Fads2 and Scd expression at 24 and 34 weeks of age was compared by real-time quantitative PCR. The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age. Although Bak mRNA abundance decreased by dietary LC, Bak/Bcl2 ratio was not affected by the treatments at 34 weeks of age. The expression of Cas3 was down-regulated, while Fads2 was up-regulated in the cockerel testicles by dietary LC at 34 weeks of age (p < .05). The results demonstrate the beneficial effects of LC supplementation in suppression of the Bak/Bcl2 ratio by altering Bak and Bcl2 mRNA abundance and, ultimately, prevention of apoptosis. Furthermore, LC increased the expression of Elovl5 and Fads2 genes which are involved in the metabolism of long chain fatty acids.",2020,"The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age.",['Thirty-six 12-week-old breeder roosters (Ross 308'],"['L-carnitine (LC): LC-0, LC-250 or LC-500\xa0mg/kg of diet']","[' Fads1, Fads2 and Scd expression', 'Cas8 expression', 'expression of Bcl2 and Elovl5', 'Bak/Bcl2 ratio', 'Bcl2 antagonist/killer', 'Alteration of Bak', 'expression of Cas3', 'suppression of the Bak/Bcl2 ratio by altering Bak and Bcl2 mRNA abundance and, ultimately, prevention of apoptosis', 'dietary LC, Bak/Bcl2 ratio', ' Bcl2, Cas3, Cas8, Cas9, Elovl2, Elovl4, Elovl5']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376515', 'cui_str': 'bcl-2 Genes'}, {'cui': 'C0574198', 'cui_str': 'Bashkir language'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]",308.0,0.0183504,"The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Sharifi', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sharafi', 'Affiliation': 'Department of Poultry Sciences, Faculty of Agriculture, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Mohammadi-Sangcheshmeh', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Abedheydari', 'Affiliation': 'Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'AliReza', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}]",Andrologia,['10.1111/and.13876']
2242,31188260,International Survey: Factors Associated With Operative Treatment of Distal Radius Fractures and Implications for the American Academy of Orthopaedic Surgeons' Appropriate Use Criteria.,"OBJECTIVES


Through an international survey, we assessed whether deciding to operatively treat an intra-articular distal radius fracture (DRF) is guided by identifiable patient and surgeon factors. In addition, we compared surgeons' treatment decisions with the American Academy of Orthopaedic Surgeons' Appropriate Use Criteria (AUC) treatment recommendations.
METHODS


This cross-sectional survey asked 224 surgeons to operatively or nonoperatively treat 28 hypothetical patients with radiographs of an intra-articular DRF. We randomized patient age (50/70 years), gender, mechanism of injury, activity level, and OTA/AO fracture type. We classified 6 fractures as ""nonclinically significant displacement"" and 22 as ""potentially clinically significant displacement."" Multilevel logistic regression analysis was performed. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported. Statistical significance was P < 0.05.
RESULTS


Patient factors independently associated with surgery included younger age (OR 6.7, P = 0.003), clinically significant fracture displacement (type B: OR 122, CI, 20-739, P < 0.001; type C: OR 59, CI, 12-300, P < 0.001), normal activity level (OR 5.0, P < 0.001), and high-energy mechanisms (OR 1.3, P = 0.002). Surgeon factors associated with recommending surgery included practicing outside the United States (Europe: OR 2.6, P < 0.001; ""other"": OR 4.8, P < 0.001). Hand surgeons most often selected surgery, as compared to orthopaedic trauma surgeons (OR 2.3, P = 0.001) and ""other orthopaedists"" (OR 2.2, P = 0.022). Thirty-seven percent of treatment decisions for patients with normal activity levels were rated by AUC recommendations as ""rarely appropriate,"" which included 91% disagreement for 70-year-olds with nonclinically significant displacement.
CONCLUSIONS


Surgeons use patient age and fracture displacement to make treatment recommendations for intra-articular DRF. We recommend that the AUC be updated to include these clinical factors as essential components in its algorithm.
LEVEL OF EVIDENCE


Therapeutic Level V. See Instructions for Authors for a complete description of levels of evidence.",2019,"Hand surgeons most often selected surgery, as compared to orthopaedic trauma surgeons (OR 2.3, P = 0.001) and ""other orthopaedists"" (OR 2.2, P = 0.022).",['224 surgeons to operatively or nonoperatively treat 28 hypothetical patients with radiographs of an intra-articular DRF'],[],"['clinically significant fracture displacement', 'normal activity levels', 'normal activity level', 'Odds ratios (ORs) and 95% confidence intervals (CIs']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",[],"[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",,0.221809,"Hand surgeons most often selected surgery, as compared to orthopaedic trauma surgeons (OR 2.3, P = 0.001) and ""other orthopaedists"" (OR 2.2, P = 0.022).","[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Kyriakedes', 'Affiliation': 'Department of Orthopaedic Surgery, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Crijns', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Teunis', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ring', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Blaine T', 'Initials': 'BT', 'LastName': 'Bafus', 'Affiliation': 'Department of Orthopaedic Surgery, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001517']
2243,31653884,Repeatability and comparison of new Corvis ST parameters in normal and keratoconus eyes.,"To evaluate the repeatability of corneal biomechanical parameters in normal and keratoconus eyes, and explore factors that affects the repeatability, and further assess the diagnostic ability of new parameters. Seventy-seven keratoconus eyes of 47 patients and 77 right eyes of 77 normal subjects were recruited in current study. All participants received three repeated measurements with 2 to 5 minutes interval. The interclass correlation coefficient (ICC), Cronbach' α and repeatability coefficient (RC) were evaluated. The liner regression analysis was used to identify factors that affect the repeatability, and linear mixed effects model was performed to compare the parameters differences. The receiver operating characteristic (ROC) curve was used to evaluate the diagnostic ability of new parameters. Eighteen parameters in normal eyes and twenty-two parameters in keratoconus eyes showed excellent repeatability (ICC ≥ 0.90). Age, axial measurement (AL), spherical equivalent, astigmatism, gender, mean keratometry (Kmean), intraocular pressure (IOP) and central corneal thickness (CCT) could affect the repeatability of new Corvis ST parameters. Compared with normal eyes, the Ambrósio's Relational Thickness horizontal (ARTh), biomechanical corrected IOP (bIOP), stiffness parameter at first applanation (SP A1) were low and the Max Inverse Radius, deformation amplitude (DA) Ratio Max [2 mm], Pachy Slope, DA Ratio Max [1 mm], Integrated Radius and Corvis Biomechanical Index (CBI) were high in keratoconus eyes (All P < 0.05). Both ARTh and CBI had high Youden index (0.870), and the corresponding cut-off values were 379.29 and 0.44. The repeatability of Corvis ST parameters was acceptable both in normal and keratoconus eyes, and new parameters could effectively diagnose keratoconus eyes from normal eyes.",2019,"The repeatability of Corvis ST parameters was acceptable both in normal and keratoconus eyes, and new parameters could effectively diagnose keratoconus eyes from normal eyes.","['normal and keratoconus eyes', 'Seventy-seven keratoconus eyes of 47 patients and 77 right eyes of 77 normal subjects']",[],"['excellent repeatability', 'Max Inverse Radius, deformation amplitude (DA) Ratio Max [2\u2009mm], Pachy Slope, DA Ratio Max [1\u2009mm], Integrated Radius and Corvis Biomechanical Index (CBI', 'Age, axial measurement (AL), spherical equivalent, astigmatism, gender, mean keratometry (Kmean), intraocular pressure (IOP) and central corneal thickness (CCT', ""interclass correlation coefficient (ICC), Cronbach' α and repeatability coefficient (RC"", 'repeatability of Corvis ST parameters', ""Ambrósio's Relational Thickness horizontal (ARTh), biomechanical corrected IOP (bIOP), stiffness parameter at first applanation (SP A1""]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}]",[],"[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0071501', 'cui_str': 'polyacrylamide-hydrazide polymer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",77.0,0.0196825,"The repeatability of Corvis ST parameters was acceptable both in normal and keratoconus eyes, and new parameters could effectively diagnose keratoconus eyes from normal eyes.","[{'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ""Henan Provincial People's Hospital, Henan Eye Hospital, Henan Eye Institute, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, 450003, China.""}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Henan Provincial People's Hospital, Henan Eye Hospital, Henan Eye Institute, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, 450003, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': ""Henan Provincial People's Hospital, Henan Eye Hospital, Henan Eye Institute, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, 450003, China.""}, {'ForeName': 'Dongqing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Henan Provincial People's Hospital, Henan Eye Hospital, Henan Eye Institute, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, 450003, China. ykszdq@163.com.""}, {'ForeName': 'Shengwei', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': ""Henan Provincial People's Hospital, Henan Eye Hospital, Henan Eye Institute, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, 450003, China. shengweiren1984@163.com.""}]",Scientific reports,['10.1038/s41598-019-51502-4']
2244,33125518,"Local application of curcumin-loaded nanoparticles as an adjunct to scaling and root planing in periodontitis: Randomized, placebo-controlled, double-blind split-mouth clinical trial.","OBJECTIVE


Assess a single local application of curcumin-loaded nanoparticles as an adjunct to scaling and root planing (SRP) in nonsurgical periodontal treatment (NPT).
MATERIALS AND METHODS


Twenty healthy subjects with periodontitis received SRP+PLGA/PLA nanoparticles loaded with 50 μg of curcumin (N-Curc) or SRP+empty nanoparticles. Probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP) were monitored at baseline, 30, 90, and 180 days. IL-1α, IL-6, TNFα, and IL-10 in the gingival crevicular fluid (GCF) were assessed by ELISA, and counts of 40 bacterial species were determined by DNA hybridization at baseline, 3, 7, and 15 days post-therapy.
RESULTS


PPD, CAL, and BOP were similarly and significantly improved in both experimental groups. There was no difference in GCF cytokine levels between experimental groups, although IL-6 was decreased at 3 days only in the N-Curc group. NPT reduced counts of red complex bacterial species in both groups. Veillonella Parvula counts increased significantly only in N-Curc group at 7 days, whereas Aggregatibacter actinomycetemcomitans counts increased significantly only in the control group from day 3 to day 15.
CONCLUSION


We conclude that a single local administration of nanoencapsulated curcumin in periodontally diseased sites had no additive benefits to NPT.
CLINICAL RELEVANCE


Our results showed that a single local application of curcumin-loaded nanoparticles associated with nonsurgical periodontal therapy did not improve clinical outcomes. Hence, our findings do not support the use of curcumin as an adjunct to nonsurgical periodontal therapy.",2020,"There was no difference in GCF cytokine levels between experimental groups, although IL-6 was decreased at 3 days only in the N-Curc group.","['periodontitis', 'Twenty healthy subjects with periodontitis received']","['SRP+PLGA/PLA nanoparticles loaded with 50 μg of curcumin (N-Curc) or SRP+empty nanoparticles', 'placebo', 'curcumin-loaded nanoparticles']","['PPD, CAL, and BOP', 'GCF cytokine levels', 'Aggregatibacter actinomycetemcomitans counts', 'Probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP', 'IL-6', 'IL-1α, IL-6, TNFα, and', 'NPT reduced counts of red complex bacterial species', 'clinical outcomes', 'Veillonella Parvula counts']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0318241', 'cui_str': 'Veillonella parvula'}]",20.0,0.159563,"There was no difference in GCF cytokine levels between experimental groups, although IL-6 was decreased at 3 days only in the N-Curc group.","[{'ForeName': 'Cindy Grace', 'Initials': 'CG', 'LastName': 'Pérez-Pacheco', 'Affiliation': 'Department of Diagnosis and Surgery, School of Dentistry at Araraquara, Sao Paulo State University (UNESP), Araraquara, SP, Brazil.'}, {'ForeName': 'Natalie Ap Rodrigues', 'Initials': 'NAR', 'LastName': 'Fernandes', 'Affiliation': 'Department of Diagnosis and Surgery, School of Dentistry at Araraquara, Sao Paulo State University (UNESP), Araraquara, SP, Brazil.'}, {'ForeName': 'Fernando Lucas', 'Initials': 'FL', 'LastName': 'Primo', 'Affiliation': 'Department of Bioprocess and Biotechnology, Faculty of Pharmaceutical Sciences of Araraquara, Sao Paulo State University (UNESP), Araraquara, SP, Brazil.'}, {'ForeName': 'Antonio Claudio', 'Initials': 'AC', 'LastName': 'Tedesco', 'Affiliation': 'Department of Chemistry, Center of Nanotechnology and Tissue Engineering- Photobiology and Photomedicine Research Group, Faculty of Philosophy, Sciences and Letters of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, SP, Brazil.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology and Oral Implantology, Dental Research Division, Universidade de Guarulhos - UNG, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology and Oral Implantology, Dental Research Division, Universidade de Guarulhos - UNG, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Morgana Rodrigues', 'Initials': 'MR', 'LastName': 'Guimarães-Stabili', 'Affiliation': 'Department of Diagnosis and Surgery, School of Dentistry at Araraquara, Sao Paulo State University (UNESP), Araraquara, SP, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rossa', 'Affiliation': 'Department of Diagnosis and Surgery, School of Dentistry at Araraquara, Sao Paulo State University (UNESP), Araraquara, SP, Brazil. c.rossa@unesp.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03652-3']
2245,33125537,The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.,"BACKGROUND


A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity.
PATIENTS AND METHODS


Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform.
RESULTS


One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
CONCLUSION


It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.",2020,"The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
","['melanoma patients receiving', 'Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated', 'metastatic melanoma patients receiving', 'One hundred forty-six melanoma patients', 'melanoma patients treated with']","['immunotherapy', 'electronic PRO']","['number of phone contacts', 'grade 2 or higher toxicity', 'overall number of AEs', 'extra visits', 'number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity', 'number of grade 3 or 4 AEs', 'number of grade 3 or 4 adverse events']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.21476,"The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
","[{'ForeName': 'Lærke K', 'Initials': 'LK', 'LastName': 'Tolstrup', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. laerke.tolstrup@rsyd.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Dieperink', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ann-Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of patient-reported outcomes,['10.1186/s41687-020-00255-0']
2246,33125587,The Treatment Ambassador Program: A Highly Acceptable and Feasible Community-Based Peer Intervention for South Africans Living with HIV Who Delay or Discontinue Antiretroviral Therapy.,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART). PWH (43 intervention, 41 controls) completed baseline, 3- and 6-month assessments. TAP was highly feasible (90% completion), with peer counselors demonstrating good intervention fidelity. Post-intervention interviews showed high acceptability of TAP and counselors, who supported autonomy, assisted with clinical navigation, and provided psychosocial support. Intention-to-treat analyses indicated increased ART initiation by 3 months in the intervention vs. control arm (12.2% [5/41] vs. 2.3% [1/43], Fisher exact p-value = 0.105; Cohen's h = 0.41). Among those previously on ART (off for > 6 months), 33.3% initiated ART by 3 months in the intervention vs. 14.3% in the control arm (Cohen's h = 0.45). Results suggest that TAP was highly acceptable and feasible among PWH not on ART.",2020,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART).","['South Africans Living with HIV', 'people with HIV (PWH) in South Africa not on antiretroviral therapy (ART']","['Feasible Community-Based Peer Intervention', 'Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention', 'TAP']",['ART initiation'],"[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",,0.0600254,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART).","[{'ForeName': 'Ingrid T', 'Initials': 'IT', 'LastName': 'Katz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. ikatz2@bwh.harvard.edu.""}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Staggs', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Marya V', 'Initials': 'MV', 'LastName': 'Gwadz', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Bassett', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cross', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Courtney', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Lungiswa', 'Initials': 'L', 'LastName': 'Tsolekile', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Panda', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Steck', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bangsberg', 'Affiliation': 'Oregon Health & Science University-Portland State University School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}]",AIDS and behavior,['10.1007/s10461-020-03063-1']
2247,33125609,Does the transcranial direct current stimulation improve dual-task postural control in young healthy adults?,"Some studies have suggested that postural balance improved after a single session of transcranial direct current stimulation (tDCS), whereas others have found minimal, if any, effects on postural performance. To address the issue of replication in tDCS studies, we re-tested the anodal tDCS effects of left dorsolateral prefrontal cortex while performing a dual-task by increasing the attentional demands associated with more challenging proprioceptive conditions. Twenty-four young adults (mean age: 21.3 ± 1.2 years) were randomly divided into two groups (a ""real tDCS"" vs. a ""sham tDCS"" group) were asked to maintain a quiet stance on a force platform. Eight trials were conducted, with eyes open and eyes closed, standing on a firm and foam surface and performing a simple and dual-task (backward counting). The postural performance was assessed by various centre-of-pressure parameters before and immediately after a 20-min tDCS session. No main effect of group and no interaction considering this factor were observed, regardless of the centre-of-pressure variables (all p values > 0.1). No evidence of a more efficient postural control emerged after a tDCS session. Beyond promising research on tDCS to maximize cognitive and behavioural enhancement, the current results indicate that caution needs to be taken when drawing firm conclusions, at least in young healthy adults.",2020,"No main effect of group and no interaction considering this factor were observed, regardless of the centre-of-pressure variables (all p values > 0.1).","['Twenty-four young adults (mean age: 21.3\u2009±\u20091.2\xa0years', 'young healthy adults']","['transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS', 'real tDCS"" vs. a ""sham tDCS"" group) were asked to maintain a quiet stance on a force platform']","['postural performance', 'dual-task postural control', 'postural balance']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}]",24.0,0.0158948,"No main effect of group and no interaction considering this factor were observed, regardless of the centre-of-pressure variables (all p values > 0.1).","[{'ForeName': 'Noëmie', 'Initials': 'N', 'LastName': 'Pineau', 'Affiliation': 'Movement-Interactions-Performance, MIP, EA 4334, Nantes Université, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Robin', 'Affiliation': 'Movement-Interactions-Performance, MIP, EA 4334, Nantes Université, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bulteau', 'Affiliation': 'INSERM-U1246 SPHERE University of Nantes, Nantes, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Thomas-Ollivier', 'Affiliation': 'Movement-Interactions-Performance, MIP, EA 4334, Nantes Université, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sauvaget', 'Affiliation': 'Movement-Interactions-Performance, MIP, EA 4334, Nantes Université, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Deschamps', 'Affiliation': 'Movement-Interactions-Performance, MIP, EA 4334, Nantes Université, CHU Nantes, 44000, Nantes, France. thibault.deschamps@univ-nantes.fr.'}]",Cognitive processing,['10.1007/s10339-020-01000-7']
2248,33125623,A Feasibility Randomized Clinical Trial of a Structured Function-Based Intervention for Elopement in Children with Autism Spectrum Disorder.,"Elopement is a common and dangerous concern in autism spectrum disorder (ASD). There is evidence that behavior analytic treatments can successfully treat elopement, but the research is limited due to small samples and treatment components varying across studies. The current study evaluated the feasibility of studying a manualized intervention for elopement, based on strategies from single-subject research, in a randomized clinical trial with 24 individuals with ASD. Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity. Initial efficacy results measured by the Aberrant Behavior Checklist, Clinical Global Impression Scale, and a Home Elopement Safety Checklist suggested improvement in the treatment group that should be studied in future research.",2020,Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity.,"['autism spectrum disorder (ASD', 'Children with Autism Spectrum Disorder', '24 individuals with ASD']",['Structured Function-Based Intervention'],"['Aberrant Behavior Checklist, Clinical Global Impression Scale']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}]",24.0,0.0929154,Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity.,"[{'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Scheithauer', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Autism and Related Disorders, 1920 Briarcliff Road, Atlanta, GA, 30329, USA. Mindy.Scheithauer@choa.org.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Call', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Autism and Related Disorders, 1920 Briarcliff Road, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lomas Mevers', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Autism and Related Disorders, 1920 Briarcliff Road, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McCracken', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Autism and Related Disorders, 1920 Briarcliff Road, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Scahill', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Autism and Related Disorders, 1920 Briarcliff Road, Atlanta, GA, 30329, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04753-4']
2249,33126334,The effectiveness and cost-effectiveness of motion style acupuncture treatment (MSAT) for acute neck pain: A multi-center randomized controlled trial.,"BACKGROUND


Neck pain is a common complaint in the general population. Despite the consistent ongoing pain and the resulting economic burden on affected individuals, there have only been a few studies investigating the treatment of acute neck pain. This study aims to evaluate the effectiveness, safety, and cost-effectiveness of the motion style acupuncture treatment (MSAT) and acupuncture treatment for acute neck pain.
METHODS


This 2-armed, parallel, multi-centered randomized controlled trial will be conducted at 4 community-based hospitals in Korea. A total of 128 subjects will be randomly assigned, at a 1:1 ratio, to the MSAT and the acupuncture treatment groups. Treatment will be administered 2 to 3 times a week for 2 weeks. The primary outcome will be the visual analog scale of neck pain on movement. The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale. This protocol has been registered at the Clinicaltrials.gov (NCT04539184).
DISCUSSION


To our knowledge, this study is the first well-designed multi-centered randomized controlled trial to evaluate the effectiveness, safety, and cost-effectiveness of MSAT on acute neck pain. The results of this study will be useful for clinicians in primary medical institutions that frequently treat acute neck pain patients and for policymakers working with national health insurance.",2020,"The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale.","['acute neck pain', '4 community-based hospitals in Korea', '128 subjects']","['motion style acupuncture treatment (MSAT) and acupuncture treatment', 'MSAT', 'motion style acupuncture treatment (MSAT']","['effectiveness, safety, and cost-effectiveness', 'acute neck pain', 'effectiveness and cost-effectiveness', 'numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale', 'visual analog scale of neck pain on movement']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",128.0,0.250602,"The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale.","[{'ForeName': 'Doori', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Seo-gu, Daejeon.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Gyeonggi-do.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Cho', 'Affiliation': 'Haeundae Jaseng Hospital of Korean Medicine, Haeundae-gu, Busan, Republic of Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}]",Medicine,['10.1097/MD.0000000000022871']
2250,33126335,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections: Study protocol for the optimal early intervention for cryptococcal antigenemia in HIV-infected patients.,"BACKGROUND


Asymptomatic cryptococcal antigenemia is a state of cryptococcal infection commonly seen in immunocompromised HIV-infected persons. Without early intervention, a proportion of HIV-infected persons with cryptococcal antigenemia may go on to develop cryptococcosis, especially cryptococcal meningitis, which is associated with high mortality. The benefits of antifungal intervention and optimal therapeutic intervention regimens for HIV-infected persons with cryptococcal antigenemia remain controversial. We therefore designed the present study in order to investigate the necessity of, and the optimal regimens for antifungal intervention in the clinical management of cryptococcal antigenemia in HIV-infected populations.
METHODS/DESIGN


This study will be an open-labeled, multi-center, prospective, randomized controlled trial, and 450 eligible participants will be randomized into a control arm and 2 intervention arms at a 1:1:1 ratio, with 150 subjects in each arm. Participants in the control arm will not receive antifungal treatment during the study period. Participants in intervention arm 1 will receive oral fluconazole 800 mg/day for 2 weeks, followed by 400 mg/day for 8 weeks and 200 mg/day for 42 weeks, and participants in intervention arm 2 will receive oral fluconazole 400 mg/day for 52 weeks. The primary outcome is the incidence of CM among the 3 groups during the study period. The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
DISCUSSION


We envisage that the results of this study will reveal the necessity of, and the optimal therapeutic regimens for, antifungal intervention in clinical management of HIV-infected patients with cryptococcal antigenemia.
TRIAL REGISTRATION


The study was registered as one of the 12 clinical trials under a general project at the Chinese Clinical Trial Registry on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.",2020,"The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
","['HIV-infected patients with cryptococcal antigenemia', 'HIV-infected patients', '450 eligible participants', 'HIV-infected persons with cryptococcal antigenemia remain controversial', 'cryptococcal antigenemia in HIV-infected populations', '12 clinical trials under a general project at the Chinese Clinical Trial Registry on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', 'immunocompromised HIV-infected persons']","['fluconazole', 'antifungal intervention', 'oral fluconazole']","['incidence of CM', 'cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0451778,"The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022874']
2251,33126364,Evaluation of competence training for the minimally trained health worker in type 2 diabetes: A cluster randomized controlled trial.,"INTRODUCTION


Type 2 diabetes mellitus is responsible for high mortality and morbidity globally and in India. India has high prevalence of the condition and the burden is set to increase exponentially in the next decade. Indians traditionally reside in rural or semi-urban areas with limited access to healthcare facilities. To overcome this, the government has introduced a cadre of health workers called Accredited Social Health Activists (ASHA) for such areas. These workers were initially trained to provide maternal & infant care but now need improved competence training to improve type 2 diabetes screening & management in these locations. The objective of the study is to assess the competence training provided to ASHA workers at the chosen study sites.
METHODOLOGY


A cluster randomized control trial has been designed. It will be conducted across 8 centers in Hyderabad & Rangareddy districts of Telangana, India. The training will be provided to ASHA workers. The tool used for training will be developed from existing sources with an emphasis on topics which require training. The training will be delivered across 6 months at each center as a classroom training. Each participant's baseline competence will be recorded using a questionnaire tool and a practical evaluation by trained public health experts. The same experts will use the same tools to assess the training post the intervention.
DISCUSSION


This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus. We anticipate that the module will provide a greater understanding of type 2 diabetes mellitus, the importance of screening of both disease and complications and improved skills for the same. The study has received the ethical approval form the Institutional Ethics Committee of the Indian Institute of Public Health Hyderabad. The registration number is: IIPHH/TRCIEC/218/2020. The trial has also been registered under the Clinical trial registry of India (CTRI) on 27 July 2020. The registration number of the trial is: CTRI/2020/07/026828. The URL of the registry trial is: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=45342&EncHid=&userName=CTRI/2020/07/026828.",2020,This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus.,"['minimally trained health worker in type 2 diabetes', '8 centers in Hyderabad & Rangareddy districts of Telangana, India']","['competence training', 'health worker training']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],,0.049894,This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus.,"[{'ForeName': 'Anirudh Gaurang', 'Initials': 'AG', 'LastName': 'Gudlavalleti', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'Giridhara R', 'Initials': 'GR', 'LastName': 'Babu', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'Onno C P', 'Initials': 'OCP', 'LastName': 'van Schayck', 'Affiliation': 'CAPHRI CaRE and Public Health Research Institute, Maastricht University, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'CAPHRI CaRE and Public Health Research Institute, Maastricht University, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Melissa Glenda', 'Initials': 'MG', 'LastName': 'Lewis', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'G V S', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}]",Medicine,['10.1097/MD.0000000000022959']
2252,33126366,The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis: A study protocol of randomized controlled trial in the community setting.,"BACKGROUND


Internet-based rehabilitation can ease the progression of chronic diseases. There had been studies on internet-based rehabilitation of knee osteoarthritis (OA), but them were conducted at home and ignored the potential benefits in the community setting. This study will explore the feasibility and effectiveness of internet-based rehabilitation accompanies wearable devices in the community setting for the patients with knee OA.
METHODS


An assessor-blinded randomized controlled feasibility trial will be performed to study the feasibility and effectiveness of internet-based rehabilitation program for the patients with knee OA in the community setting. Forty participants with knee OA will be recruited and randomly allocated into internet-based rehabilitation group (IRG) or control group (CG). The interventions of IRG will be performed in the community setting via web-based platform and wearable devices. The outcome measures will be conducted at baseline, and post-intervention 6 weeks, 12 weeks during the study. The feasibility will be tested by the proportion of participants who will complete the internet-based rehabilitation program within 12 weeks in IRG as well as the compliance and satisfaction. Additionally, the effectiveness of internet-based rehabilitation will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index, 11-point Numerical Rating Scale and Short Form-36 quality-of-life questionnaire.
CONCLUSION


The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
TRIAL REGISTRATION NUMBER


The study was registered in the clinical trial registry ChiCTR2000033397.",2020,"The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
","['Forty participants with knee OA', 'patients with knee OA in the community setting', 'patients with knee osteoarthritis', 'patients with knee OA']","['internet-based rehabilitation group (IRG) or control group (CG', 'internet-based rehabilitation', 'internet-based rehabilitation program', 'internet-based rehabilitation program and community-based interventions', 'internet-based rehabilitation accompanies wearable devices']","['Western Ontario and McMaster Universities Osteoarthritis Index, 11-point Numerical Rating Scale and Short Form-36 quality-of-life questionnaire']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0575105,"The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
","[{'ForeName': 'Su-Hang', 'Initials': 'SH', 'LastName': 'Xie', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Si-Yi', 'Initials': 'SY', 'LastName': 'Zhu', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Cheng-Qi', 'Initials': 'CQ', 'LastName': 'He', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}]",Medicine,['10.1097/MD.0000000000022961']
2253,33126867,Randomised prospective phase II trial in multiple brain metastases comparing outcomes between hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT study protocol.,"BACKGROUND


Recent evidence supports hippocampal avoidance with whole brain radiotherapy (HA-WBRT) as the recommended treatment option in patients with good prognosis and multiple brain metastases as this results in better neurocognitive preservation compared to whole brain radiotherapy. However, there is often poor tumour control with this technique due to the low doses given. Stereotactic Radiosurgery (SRS), a form of focused radiotherapy which is given to patients who have a limited number of brain metastases, delivers a higher radiation dose to the metastases resulting in better target lesion control. With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes. This technique is abbreviated to HA-SIB-WBRT or HA-WBRT+SIB.
METHODS


We hypothesise that the SIB in HA-SIB-WBRT (experimental arm) will result in better tumour control compared to HA-WBRT (control arm). This may also lead to better intracranial disease control as well as functional and survival outcomes. We aim to conduct a prospective randomised phase II trial in patients who have good performance status, multiple brain metastases (4-25 lesions) and a reasonable life expectancy (> 6 months). These patients will be stratified according to the number of brain metastases and randomised between the 2 arms. We aim for a recruitment of 100 patients from a single centre over a period of 2 years. Our primary endpoint is target lesion control. These patients will be followed up over the following year and data on imaging, toxicity, quality of life, activities of daily living and cognitive measurements will be collected at set time points. The results will then be compared across the 2 arms and analysed.
DISCUSSION


Patients with brain metastases are living longer. Maintaining functional independence and intracranial disease control is thus increasingly important. Improving radiotherapy treatment techniques could provide better control and survival outcomes whilst maintaining quality of life, cognition and functional capacity. This trial will assess the benefits and possible toxicities of giving a SIB to HA-WBRT.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT04452084 . Date of registration 30th June 2020.",2020,"With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes.","['patients with good prognosis and multiple brain metastases', '100 patients from a single centre over a period of 2\u2009years', 'patients who have good performance status, multiple brain metastases (4-25 lesions) and a reasonable life expectancy (>\u20096\u2009months']","['hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT', 'hippocampal avoidance with whole brain radiotherapy (HA-WBRT', 'Stereotactic Radiosurgery (SRS']","['quality of life, cognition and functional capacity', 'imaging, toxicity, quality of life, activities of daily living and cognitive measurements', 'target lesion control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0809571,"With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes.","[{'ForeName': 'Brendan Seng Hup', 'Initials': 'BSH', 'LastName': 'Chia', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore. brendan.chia.s.h@singhealth.com.sg.'}, {'ForeName': 'Jing Yun', 'Initials': 'JY', 'LastName': 'Leong', 'Affiliation': 'Department of Adult Neuro-developmental Service, Institute of Mental Health Singapore, 10 Buangkok View, Singapore, 539747, Singapore.'}, {'ForeName': 'Ashley Li Kuan', 'Initials': 'ALK', 'LastName': 'Ong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Shi Hui', 'Initials': 'SH', 'LastName': 'Poon', 'Affiliation': 'Department of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Melvin Lee Kiang', 'Initials': 'MLK', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Kevin Lee Min', 'Initials': 'KLM', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kusumawidjaja', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Eu Tiong', 'Initials': 'ET', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Fuh Yong', 'Initials': 'FY', 'LastName': 'Wong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Tih Shih', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}]",BMC cancer,['10.1186/s12885-020-07565-y']
2254,33126902,Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis.,"BACKGROUND


Expiratory muscle weakness leads to difficult ventilator weaning. Maintaining their activity with functional electrical stimulation (FES) may improve outcome. We studied feasibility of breath-synchronized expiratory population muscle FES in a mixed ICU population (""Holland study"") and pooled data with our previous work (""Australian study"") to estimate potential clinical effects in a larger group.
METHODS


Holland: Patients with a contractile response to FES received active or sham expiratory muscle FES (30 min, twice daily, 5 days/week until weaned). Main endpoints were feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety. Pooled: Data on respiratory muscle thickness and ventilation duration from the Holland and Australian studies were combined (N = 40) in order to estimate potential effect size. Plasma cytokines (day 0, 3) were analyzed to study the effects of FES on systemic inflammation.
RESULTS


Holland: A total of 272 sessions were performed (active/sham: 169/103) in 20 patients (N = active/sham: 10/10) with a total treatment compliance rate of 91.1%. No FES-related serious adverse events were reported. Pooled: On day 3, there was a between-group difference (N = active/sham: 7/12) in total abdominal expiratory muscle thickness favoring the active group [treatment difference (95% confidence interval); 2.25 (0.34, 4.16) mm, P = 0.02] but not on day 5. Plasma cytokine levels indicated that early FES did not induce systemic inflammation. Using a survival analysis approach for the total study population, median ventilation duration and ICU length of stay were 10 versus 52 (P = 0.07), and 12 versus 54 (P = 0.03) days for the active versus sham group. Median ventilation duration of patients that were successfully extubated was 8.5 [5.6-12.2] versus 10.5 [5.3-25.6] days (P = 0.60) for the active (N = 16) versus sham (N = 10) group, and median ICU length of stay was 10.5 [8.0-14.5] versus 14.0 [9.0-19.5] days (P = 0.36) for those active (N = 16) versus sham (N = 8) patients that were extubated and discharged alive from the ICU. During ICU stay, 3/20 patients died in the active group versus 8/20 in the sham group (P = 0.16).
CONCLUSION


Expiratory muscle FES is feasible in selected ICU patients and might be a promising technique within a respiratory muscle-protective ventilation strategy. The next step is to study the effects on weaning and ventilator liberation outcome.
TRIAL REGISTRATION


ClinicalTrials.gov, ID NCT03453944. Registered 05 March 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03453944 .",2020,No FES-related serious adverse events were reported.,"['mechanically ventilated patients', 'Holland', 'Patients with a\xa0contractile response to FES received']","['breath-synchronized expiratory population muscle FES', 'active or sham expiratory muscle FES', 'Breath-synchronized electrical stimulation', 'functional electrical stimulation (FES']","['systemic inflammation', 'Plasma cytokine levels', 'median ventilation duration and ICU length of stay', 'feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety', 'Median ventilation duration', 'median ICU length of stay', 'serious adverse events', 'total abdominal expiratory muscle thickness']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",272.0,0.450318,No FES-related serious adverse events were reported.,"[{'ForeName': 'Annemijn H', 'Initials': 'AH', 'LastName': 'Jonkman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Frenzel', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Euan J', 'Initials': 'EJ', 'LastName': 'McCaughey', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Angus J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Liberate Medical LLC, Crestwood, KY, 40014, USA.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Collins', 'Affiliation': 'Prince of Wales Hospital, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Gandevia', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hoiting', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Oppersma', 'Affiliation': 'Cardiovascular and Respiratory Physiology Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lisanne H', 'Initials': 'LH', 'LastName': 'Roesthuis', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schouten', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Shi', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Veltink', 'Affiliation': 'Department of Biomedical Signals and Systems, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Heder J', 'Initials': 'HJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Cyndi', 'Initials': 'C', 'LastName': 'Shannon Weickert', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Wiedenbach', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Yingrui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Tuinman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Angélique M E', 'Initials': 'AME', 'LastName': 'de Man', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Leo M A', 'Initials': 'LMA', 'LastName': 'Heunks', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands. L.Heunks@amsterdamumc.nl.'}]","Critical care (London, England)",['10.1186/s13054-020-03352-0']
2255,33126910,Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated.
TRIAL DESIGN


This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial.
PARTICIPANTS


The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] will also be excluded from the trial.
INTERVENTION AND COMPARATOR


In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute's COVID-19 treatment protocol and the treating physician's clinical judgment.
MAIN OUTCOMES


All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions.
RANDOMISATION


The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy).
BLINDING (MASKING)


The study will be an open-label trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data.
TRIAL STATUS


The institutional ethical committee has approved the study protocol (Protocol version 3.0 [June 2020]). Participant recruitment starting date: 28 th  July 2020 Participant recruitment ending date: 27 th  January 2021 Trial duration: 6 months TRIAL REGISTRATION: The trial has been prospectively registered in Clinical Trial Registry - India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020)].
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial.,"['28 th  July 2020 Participant recruitment ending date: 27 th  January 2021', 'Patients with SARS-CoV-2 Infection', 'Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] ', 'patients infected with SARS-CoV-2 who require hospitalisation', 'COVID-19 patients', '200 patients are included in each arm (i.e., total 800 patients']","['statins or aspirin, prior statin or aspirin', 'Atorvastatin and Aspirin', 'aspirin and atorvastatin', 'CTRI/2020/07/026791', 'Atorvastatin', 'statin (atorvastatin) and/or aspirin', 'statin or aspirin [including cyclosporine', 'atorvastatin (statin) and/or aspirin', 'aspirin', 'atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy', 'fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine']","['serum inflammatory markers (C-reactive protein and Interleukin-6', 'Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding', 'clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality', 'progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality', 'coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications', 'Troponin I, and creatine phosphokinase (CPK']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0806020', 'cui_str': 'End date'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936462', 'cui_str': 'Fibric Acid Derivatives'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0360363', 'cui_str': 'Azole antifungal'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",800.0,0.175146,All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial.,"[{'ForeName': 'Nirmal', 'Initials': 'N', 'LastName': 'Ghati', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Bhati', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Bhushan', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Manjit', 'Initials': 'M', 'LastName': 'Mahendran', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Tanima', 'Initials': 'T', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Laboratory Medicine, National Cancer Institute (Jhajjar, Haryana), All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Kalaivani', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Laboratory Oncology, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anaesthesia, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Deepti', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India. deeptikailath@gmail.com.'}]",Trials,['10.1186/s13063-020-04840-y']
2256,33126918,Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder: study protocol for a randomized controlled trial.,"BACKGROUND


There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) stuck-moving needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.
METHODS


Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital, and Qingyang Second People's Hospital in China from February 2020 to January 2021. One hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the stuck-moving needle acupuncture group, common acupuncture control group, and physical exercise control group. This trial will include a 1-week baseline period, a 3-week treatment period, and a 12-week follow-up period. During the 3 weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include measurement of pressure pain threshold (PPT), pressure pain tolerance (PTT), Oxford Shoulder Score (OSS), 36-item short form survey, and patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.
DISCUSSION


The results of this trial will allow us to compare the difference in efficacy between stuck-moving needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.
TRIAL REGISTRATION


Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). Registered on 22 December 2019. http://www.chictr.org.cn/showproj.aspx?proj=47354.",2020,The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period.,"['patients with idiopathic frozen shoulder', 'One hundred and eight frozen shoulder patients', ""three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital, and Qingyang Second People's Hospital in China from February 2020 to January 2021""]","['myofascial trigger point (MTrp) stuck-moving needle acupuncture', 'stuck-moving needle acupuncture group, common acupuncture control group, and physical exercise control group', 'Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder', 'acupuncture', 'stuck-moving needle acupuncture']","['efficacy and safety', 'pain and range of motions', 'Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM', 'measurement of pressure pain threshold (PPT), pressure pain tolerance (PTT), Oxford Shoulder Score (OSS), 36-item short form survey, and patient satisfaction evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",108.0,0.133771,The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 300073, China.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Jingbao', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Maomao', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Shengen', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Yuan Hao', 'Initials': 'YH', 'LastName': 'Du', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. jpjs_cn@sina.com.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. xiatian76@163.com.'}]",Trials,['10.1186/s13063-020-04799-w']
2257,33125902,Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults.,"PURPOSE


Coblation tonsillectomy (TE) increases gradually in China. Hemorrhage is the main complication after tonsillectomy. The conclusions of the studies about suture after tonsillectomy are conflicting. To compare the post-tonsillectomy hemorrhage (PTH) rates in patients who underwent coblation with vs. without suture.
MATERIALS AND METHODS


This was a randomized controlled study of adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019. The patients were randomized to TE with or without suture. The primary endpoint was the secondary PTH. The secondary endpoints included the primary PTH, grade of PTH, and incidence of PTH within 4 weeks post-TE.
RESULTS


There were no differences between the two groups regarding sex, age, disease course, and BMI (all P > 0.05). The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016). Compared with non-suture group, the incidence of PTH within 4 weeks (2.8% vs. 10.6%, P = 0.009) and the PTH degree (P = 0.02) were all significantly lower in the suture group.
CONCLUSION


Intraoperative suture reduces the secondary PTH in adult patients who underwent coblation tonsillectomy. The incidence of PTH within 4 weeks, PTH degree and pain might all improved for intraoperative suture.",2020,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","['Chinese adults', 'patients who underwent coblation with vs. without suture', 'adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019', 'adult patients who underwent coblation tonsillectomy']","['Coblation tonsillectomy (TE', 'TE with or without suture', 'coblation tonsillectomy with and without suture', 'Intraoperative suture']","['primary PTH, grade of PTH, and incidence of PTH within 4\xa0weeks post-TE', 'Postoperative hemorrhage', 'post-tonsillectomy hemorrhage (PTH) rates', 'incidence of PTH within 4\xa0weeks, PTH degree and pain', 'occurrence of secondary PTH', 'PTH degree', 'secondary PTH', 'incidence of PTH']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C1279603', 'cui_str': 'Primary post tonsillectomy hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1279604', 'cui_str': 'Secondary post tonsillectomy hemorrhage'}]",,0.0848415,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China. Electronic address: 13923457897@139.com.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology, 8th Medical Center, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102760']
2258,33125909,Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol.,"BACKGROUND


The Lung Cancer Master Protocol (Lung-MAP; S1400) is a completed biomarker-driven master protocol designed to address an unmet need for better therapies for squamous non-small-cell lung cancer. Lung-MAP (S1400) was created to establish an infrastructure for biomarker screening and rapid regulatory intent evaluation of targeted therapies and was the first biomarker-driven master protocol initiated with the US National Cancer Institute (NCI).
METHODS


Lung-MAP (S1400) was done within the National Clinical Trials Network of the NCI using a public-private partnership. Eligible patients were aged 18 years or older, had stage IV or recurrent squamous non-small-cell lung cancer, had previously been treated with platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. The study included a screening component using the FoundationOne assay (Foundation Medicine, Cambridge, MA, USA) for next-generation sequencing, and a clinical trial component with biomarker-driven substudies and non-match substudies for patients who were ineligible for biomarker-driven substudies. Patients were pre-screened and received their substudy assignment upon progression, or they were screened at progression and received their substudy assignment upon completion of testing. Patients could enrol onto additional substudies after progression on a substudy. The study is registered with ClinicalTrials.gov, NCT02154490, and all research related to Lung-MAP (S1400) is completed.
FINDINGS


Between June 16, 2014, and Jan 28, 2019, 1864 patients enrolled and 1841 (98·9%) submitted tissue. 1674 (90·9%) of 1841 patients had biomarker results, and 1404 (83·9%) of 1674 patients received a substudy assignment. Of the assigned patients, 655 (46·7%) registered to a substudy. The biomarker-driven substudies evaluated taselisib (targeting PIK3CA alterations), palbociclib (cell cycle gene alterations), AZD4547 (FGFR alteration), rilotumumab plus erlotinib (MET), talazoparib (homologous recombination repair deficiency), and telisotuzumab vedotin (MET). The non-match substudies evaluated durvalumab, and nivolumab plus ipilimumab for anti-PD-1 or anti-PD-L1-naive disease, and durvalumab plus tremelimumab for anti-PD-1 or anti-PD-L1 relapsed disease. Combining data from the substudies, ten (7·0%) of 143 patients responded to targeted therapy, 53 (16·8%) of 315 patients responded to anti-PD-1 or anti-PD-L1 therapy for immunotherapy-naive disease, and three (5·4%) of 56 responded to docetaxel in the second line of therapy. Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups. Median progression-free survival was 2·5 months (95% CI 1·7-2·8) for the targeted therapy groups, 2·7 months (1·9-2·9) for the docetaxel groups, and 3·0 months (2·7-3·9) for the anti-PD-1 or anti-PD-L1-containing groups.
INTERPRETATION


Lung-MAP (S1400) met its goal to quickly address biomarker-driven therapy questions in squamous non-small-cell lung cancer. In early 2019, a new screening protocol was implemented expanding to all histological types of non-small-cell lung cancer and to add focus on immunotherapy combinations for anti-PD-1 and anti-PD-L1 therapy-relapsed disease. With these changes, Lung-MAP continues to meet its goal to focus on unmet needs in the treatment of advanced lung cancers.
FUNDING


US National Institutes of Health, and AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, and Pfizer through the Foundation for the National Institutes of Health.",2020,"Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups.","['Between June 16, 2014, and Jan 28, 2019', 'Lung-MAP', 'Patients were pre-screened and received their substudy assignment upon progression, or they were screened at progression and received their substudy assignment upon completion of testing', 'Eligible patients were aged 18 years or older, had stage IV or recurrent squamous non-small-cell lung cancer, had previously been treated with platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients who were ineligible for biomarker-driven substudies', '143 patients responded to targeted therapy, 53 (16·8%) of 315 patients responded to', '1674 (90·9%) of 1841 patients had biomarker results, and 1404 (83·9%) of 1674 patients received a substudy assignment', '1864 patients enrolled and 1841 (98·9%) submitted tissue']","['docetaxel', 'anti-PD-1 or anti-PD-L1 therapy']","['Median progression-free survival', 'Lung-MAP', 'Median overall survival', 'palbociclib (cell cycle gene alterations), AZD4547 (FGFR alteration), rilotumumab plus erlotinib (MET), talazoparib (homologous recombination repair deficiency), and telisotuzumab vedotin (MET']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1720176', 'cui_str': 'Upon'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0243037', 'cui_str': 'cdc Genes'}, {'cui': 'C2981795', 'cui_str': 'AZD4547'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}, {'cui': 'C2743963', 'cui_str': 'rilotumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]",1864.0,0.0692009,"Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups.","[{'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: mredman@fredhutch.org.'}, {'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Minichiello', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Hirsch', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, Columbia University Medical College, New York, NY, USA.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Hematology and Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Leighl', 'Affiliation': 'Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Highleyman', 'Affiliation': 'SWOG Data Operations Center, Cancer Research and Biostatistics, Seattle, WA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Miwa', 'Affiliation': 'SWOG Operations Office, San Antonio, TX, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'LeBlanc', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shakun', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Ellen V', 'Initials': 'EV', 'LastName': 'Sigal', 'Affiliation': 'Friends of Cancer Research, Washington, DC, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Adam', 'Affiliation': 'Foundation for the National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wholley', 'Affiliation': 'Foundation for the National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sigman', 'Affiliation': 'CCS Associates, San Jose, CA, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Smolich', 'Affiliation': 'CCS Associates, San Jose, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office and Knight Cancer Institute, School of Medicine, Oregon Health and Science University, Portland, OR, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Department of Internal Medicine, UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'Department of Internal Medicine, UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Department of Medicine, Yale Cancer Center, New Haven, CT, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30475-7']
2259,33125944,Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).,"BACKGROUND


Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).
METHODS


This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m 2  Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.
RESULTS


Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV: NCT02999087.",2020,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","['locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN', 'Between September 2017 and August 2018, 82 patients with LA-SCCHN', 'locally advanced squamous-cell carcinoma of the head and neck']","['avelumab with cetuximab and radiotherapy', 'cisplatin', 'avelumab-cetuximab-RT combination', 'Avelumab-cetuximab-radiotherapy', 'SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin', 'unfit to cisplatin', 'IMRT with cetuximab and avelumab', 'entire radiotherapy']","['Grade ≥IV AEs', 'mucositis, radio-dermatitis, and dysphagia', 'grade ≥IV AEs', 'grade V haemorrhage']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0711299,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Le Havre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU, Amiens, France.'}, {'ForeName': 'Cedrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Liem', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': 'ICO Rene-Gauducheau, Nantes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Colin-Batailhou', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.008']
2260,33126051,"More precise dosing of acenocoumarol for better control in patients aged above 80 years, a randomised controlled pilot study.","INTRODUCTION


Many elderly patients are confined to treatment with vitamin K antagonists (VKA) instead of direct oral anticoagulants (DOACs). However, quality of VKA treatment declines with age. This might be caused by the lower dose requirements with increasing age, which result in relatively large day-by-day VKA dose differences. Therefore, more precise dosing with smaller dose increments might improve quality of VKA treatment in the elderly.
METHODS


We randomised 80 elderly patients (≥80 years, using 0.5-2 mg acenocoumarol daily) to either conventional dosing with 1.0 mg acenocoumarol increments, or more precise dosing with 0.5 mg increments, to assess effect sizes and feasibility of a larger trial. We compared changes in the time in therapeutic range (TTR), INR variability and anticoagulation-related quality of life (measured with the PACT-Q) between treatment groups.
RESULTS


Overall, baseline TTR was 61.3 ± 19.2. After six study months, TTR had improved to 69.5 ± 19.7 in the precise dosing group versus 67.7 ± 21.2 in the conventional dosing group (absolute difference 3.4 (95% CI -6.7 to 13.6)). The between-groups difference in INR variability was not assessed because of baseline differences. PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7). Satisfaction decreased equally in both groups with -6.4 ± 8.6/100. Four dosing errors occurred: three with precise and one with conventional dosing.
CONCLUSION


Although more precise dosing of acenocoumarol leads to a slightly higher TTR, this effect is too small to convey a relevant clinical benefit and could be abolished by the increased risk of medication errors.",2020,"PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7).","['patients aged above 80\xa0years', '80 elderly patients (≥80\xa0years, using 0.5-2\xa0mg acenocoumarol daily) to either', 'Many elderly patients']","['conventional dosing with 1.0\xa0mg acenocoumarol', 'acenocoumarol', 'vitamin K antagonists (VKA']","['time in therapeutic range (TTR), INR variability and anticoagulation-related quality of life', 'Satisfaction', 'TTR', 'INR variability', 'quality of VKA treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0000956', 'cui_str': 'Acenocoumarol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000956', 'cui_str': 'Acenocoumarol'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",80.0,0.0462563,"PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; Certe Thrombosis Service Groningen, Groningen, the Netherlands.'}, {'ForeName': 'J H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; Certe Thrombosis Service Groningen, Groningen, the Netherlands. Electronic address: j.h.a.van.miert@umcg.nl.'}, {'ForeName': 'N J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, the Netherlands.'}, {'ForeName': 'H A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.10.018']
2261,33126555,"Impact of Physical Activity and Weight Loss on Fat Mass, Glucose Metabolism, and Inflammation in Older African Americans with Osteoarthritis.","(1) Background: There are currently very few interventions performed within a community setting that compare the effects of physical activity (PA) versus PA plus weight loss on cancer and chronic disease risk in older African Americans. Therefore, we investigated the impact of an 8 week (24 session) PA intervention compared to a PA plus weight loss intervention on fat mass, glucose metabolism, and markers of inflammation in older, overweight and obese African Americans. (2) Methods: Subjects were randomized to a PA ( n =  83) or PA plus weight loss ( n =  72) intervention that met three times weekly for 8 weeks. At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined. (3) Results: Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88%). The PA plus weight loss group lost more total and visceral fat than the PA group (-4.0% vs. +0.6% and -4.1% vs. +3.7%, respectively,  p  < 0.01 for both). Changes in inflammation and glucose metabolism were similar between groups post-intervention. Within the PA plus weight loss group only, serum insulin and HOMA-IR decreased significantly. (4) Conclusions: PA combined with weight loss can decrease total and visceral fat mass and improve insulin sensitivity, confirming that these cancer- and chronic disease-related risk factors are influenced by relatively modest lifestyle changes in the short term.",2020,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","['Older African Americans with Osteoarthritis', 'older, overweight and obese African Americans', 'Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88', 'older African Americans']","['Physical Activity and Weight Loss', 'PA', 'physical activity (PA) versus PA plus weight loss', 'PA plus weight loss intervention']","['anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR', 'inflammation and glucose metabolism', 'total and visceral fat mass and improve insulin sensitivity', 'total and visceral fat', 'serum insulin and HOMA-IR', 'Fat Mass, Glucose Metabolism, and Inflammation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0259348,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLeod', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Castellanos', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Olender', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Giamila', 'Initials': 'G', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12113299']
2262,33126692,Optimising Web-Based Computer-Tailored Physical Activity Interventions for Prostate Cancer Survivors: A Randomised Controlled Trial Examining the Impact of Website Architecture on User Engagement.,"BACKGROUND


Web-based computer-tailored interventions can assist prostate cancer survivors to become more physically active by providing personally relevant behaviour change support. This study aimed to explore how changing the website architecture (free choice vs. tunnelled) impacted engagement within a physical activity computer-tailored intervention targeting prostate cancer survivors.
METHODS


On a 2:2:1 ratio, 71 Australian prostate cancer survivors with local or locally advanced disease (mean age: 66.6 years ± 9.66) were randomised into either a free-choice (N = 27), tunnelled (N = 27) or minimal intervention control arm (N =17). The primary outcome was differences in usage of the physical activity self-monitoring and feedback modules between the two intervention arms. Differences in usage of other website components between the two intervention groups were explored as secondary outcomes. Further, secondary outcomes involving comparisons between all study groups (including the control) included usability, personal relevance, and behaviour change.
RESULTS


The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4),  p  = 0.01. However, free-choice participants were significantly more likely to have engaged with the social support ( p  = 0.008) and habit formation ( p  = 0.003) 'once-off' modules compared to the standard tunnelled arm. There were no other between-group differences found for any other study outcomes.
CONCLUSION


This study indicated that website architecture influences behavioural engagement. Further research is needed to examine the impact of differential usage on mechanisms of action and behaviour change.",2020,"The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4),  p  = 0.01.","['71 Australian prostate cancer survivors with local or locally advanced disease (mean age: 66.6 years ± 9.66', 'Prostate Cancer Survivors', 'prostate cancer survivors']","['Optimising Web-Based Computer-Tailored Physical Activity Interventions', 'physical activity computer-tailored intervention', 'minimal intervention control']","['habit formation', 'usage of the physical activity self-monitoring and feedback modules', 'usability, personal relevance, and behaviour change', 'average number of physical activity self-monitoring and feedback modules']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",71.0,0.0797526,"The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4),  p  = 0.01.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finlay', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Evans', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, Central Queensland University, Rockhampton 4701, QLD, Australia.'}, {'ForeName': 'Camille E', 'Initials': 'CE', 'LastName': 'Short', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}]",International journal of environmental research and public health,['10.3390/ijerph17217920']
2263,33126825,Altered Antibody Responses in Persons Infected with HIV-1 While Using PrEP.,"BACKGROUND


Pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, although effectiveness is dependent upon adherence. It is important to characterize the impact of PrEP on HIV antibody responses in people who experience breakthrough infections in order to understand the potential impact on timely diagnosis and treatment.
METHODS


Longitudinal HIV-1-specific antibody responses were evaluated in 42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (placebo=28; PrEP=14) who acquired HIV while receiving PrEP. HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120) were measured in the plasma using a customized Bio-Plex (Bio-Rad Laboratories) assay. A survival analysis was performed for each biomarker to compare the distribution of times at which study subjects exceeded the recent/long-term assay threshold, comparing PrEP and placebo treatment groups. We fit mixed-effects models to identify longitudinal differences in antibody levels and avidity between groups.
RESULTS


Overall, longitudinal antibody levels and avidity were notably lower in the PrEP breakthrough group compared to the placebo group. Survival analyses demonstrated a difference in time to antibody reactivity between treatment groups for all Bio-Plex biomarkers. Longitudinal gp120 antibody levels within the PrEP breakthrough group were decreased compared to the placebo group. When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
CONCLUSION


We demonstrate hindered envelope antibody maturation in PWID who became infected while receiving PrEP in the Bangkok Tenofovir Study, which has significant implications for HIV diagnosis. Delayed maturation of the antibody response to HIV may increase the time to detection for antibody-based tests.",2020,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","['Persons Infected with HIV-1', '42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (placebo=28; PrEP=14) who acquired HIV while receiving PrEP']","['Pre-exposure prophylaxis (PrEP', 'placebo', 'PrEP']","['HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120', 'Altered Antibody Responses', 'Longitudinal gp120 antibody levels', 'gp120 and gp160 antibody levels', 'time to antibody reactivity', 'Overall, longitudinal antibody levels and avidity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0369497', 'cui_str': 'Human immunodeficiency virus type 1 antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017278', 'cui_str': 'env Gene Products'}, {'cui': 'C0019692', 'cui_str': 'Envelope Protein gp41, HIV'}, {'cui': 'C0062790', 'cui_str': 'gp160(HIV)'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",42.0,0.0388449,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Parker', 'Affiliation': 'Centers for Disease Control and Prevention, 1242, Atlanta, Georgia, United States; ivana.kennedy@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Centers for Disease Control and Prevention, 1242, Atlanta, Georgia, United States; uwm4@cdc.gov.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Centers for Disease Control and Prevention, NCHHSTP/LB, 1600 Clifton Rd, MS A-25, Atlanta, Georgia, United States, 30329; zhp6@cdc.gov.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Martin', 'Affiliation': 'CDC, NCHSTP, Atlanta, Georgia, United States; znd9@cdc.gov.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Thailand Ministry of Public Health, Nonthaburi, Thailand; suphakv@yahoo.com.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Ministry of Public Health, Tivanon rd., Nonthburi, Thailand, 11000; hpx0@cdc.gov.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'McNicholl', 'Affiliation': 'Centers for Disease Control and Prevention, DHAP, 1600 Clifton Rd, Atlanta, Georgia, United States, 30306; jkm7@cdc.gov.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hickey', 'Affiliation': 'Centers for Disease Control and Prevention, 1242, Atlanta, Georgia, United States; ANH9@cdc.gov.'}, {'ForeName': 'J Gerardo', 'Initials': 'JG', 'LastName': 'Garcia-Lerma', 'Affiliation': 'CDC, Atlanta, Laboratory Branch/DHAP, 1600 Clifton Rd, Atlanta, Georgia, United States, Ga; JNG5@CDC.GOV.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Metropolitan Administration, 159241, Bangkok, Bangkok, Thailand; kachitc@gmail.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Curtis', 'Affiliation': 'Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, Georgia, United States, 30329; czv2@cdc.gov.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0137']
2264,33127287,Combined Use of Rotational Thromboelastometry (Rotem) and Platelet Impedance Aggregometry (Multiplate Analyzer) in Cyanotic and Acyanotic Infants and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass: Subgroup Analysis of a Randomized Clinical Trial.,"OBJECTIVES


Few studies have investigated the Multiplate platelet function analyzer in pediatrics. The authors evaluated Multiplate combined with Rotem in terms of guiding platelet transfusion after pediatric cardiac surgery with cardiopulmonary bypass (CPB). The authors further compared coagulation parameters between cyanotic and acyanotic patients.
DESIGN


Subgroup analysis of a randomized clinical trial.
SETTING


Tertiary hospital.
PARTICIPANTS


Patients weighing between seven and 15 kg.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


Rotem and Multiplate tests were performed (1) after anesthesia induction, (2) upon CPB separation, and (3) upon intensive care unit arrival. Among a total of 59 subjects, 9 patients required platelet transfusion. In multivariate linear regression, analysis EXTEM maximum clot firmness upon CPB separation was associated with the volume of transfused platelets (regression coefficient = -0.348 [95% confidence interval -1.006 to -0.028]; p = 0.039). No such association was found for the Multiplate test. Acyanotic and cyanotic heart disease were present in 32 and 27 children, respectively. There were no significant differences between these two groups in terms of platelet count and function. Postoperative blood loss was significantly higher in the cyanotic group compared with the acyanotic arm (p = 0.015; difference [95% confidence interval -2.40 {-4.20 to -0.60}]). There were no differences between groups regarding transfusion of allogeneic blood products.
CONCLUSIONS


This study showed that Rotem, but not Multiplate results, were associated with platelet transfusion in pediatric cardiac surgery with no intake of platelet inhibitors. The usefulness of combining these tests in platelet transfusion decision-making needs to be evaluated in larger populations.",2020,Postoperative blood loss was significantly higher in the cyanotic group compared with the acyanotic arm (p = 0.015; difference [95% confidence interval -2.40 {-4.20 to -0.60}]).,"['pediatrics', 'Tertiary hospital', 'Cyanotic and Acyanotic Infants and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass', 'Patients weighing between seven and 15 kg', 'pediatric cardiac surgery with cardiopulmonary bypass (CPB']",['Rotational Thromboelastometry (Rotem) and Platelet Impedance Aggregometry (Multiplate Analyzer'],"['Postoperative blood loss', 'Acyanotic and cyanotic heart disease', 'platelet count and function', 'platelet transfusion']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332580', 'cui_str': 'Cyanotic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1394290', 'cui_str': 'Cyanotic heart disease'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}]",59.0,0.167417,Postoperative blood loss was significantly higher in the cyanotic group compared with the acyanotic arm (p = 0.015; difference [95% confidence interval -2.40 {-4.20 to -0.60}]).,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Dieu', 'Affiliation': 'Department of Anesthesiology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Van Regemorter', 'Affiliation': 'Department of Anesthesiology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Detaille', 'Affiliation': 'Department of Pediatric Intensive Care Unit, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Houtekie', 'Affiliation': 'Department of Pediatric Intensive Care Unit, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Eeckhoudt', 'Affiliation': 'Department of Hematology, Laboratoires des Hôpitaux Universitaires de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Khalifa', 'Affiliation': 'Department of Anesthesiology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': 'Department of Anesthesiology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Stéphan', 'Initials': 'S', 'LastName': 'Clement De Clety', 'Affiliation': 'Department of Pediatric Intensive Care Unit, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Poncelet', 'Affiliation': 'Department of Cardiac Surgery, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': 'Department of Anesthesiology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium. Electronic address: mona.momeni@uclouvain.be.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.09.133']
2265,33127291,Respiratory muscle training in late-onset Pompe disease: Results of a sham-controlled clinical trial.,"To address progressive respiratory muscle weakness in late-onset Pompe disease (LOPD), we developed a 12-week respiratory muscle training (RMT) program. In this exploratory, double-blind, randomized control trial, 22 adults with LOPD were randomized to RMT or sham-RMT. The primary outcome was maximum inspiratory pressure (MIP). Secondary and exploratory outcomes included maximum expiratory pressure (MEP), peak cough flow, diaphragm ultrasound, polysomnography, patient-reported outcomes, and measures of gross motor function. MIP increased 7.6 cmH 2 O (15.9) in the treatment group and 2.7 cmH 2 O (7.6) in the control group (P = 0.4670). MEP increased 14.0 cmH 2 O (25.9) in the treatment group and 0.0 cmH 2 O (12.0) in the control group (P = 0.1854). The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160). The magnitude of changes in MIP and MEP in the treatment group were consistent with our pilot findings but did not achieve statistical significance in comparison to controls. Explanations for this include inadequate power and baseline differences in subject characteristics between groups. Additionally, control group subjects appeared to exhibit an active response to sham-RMT and therefore sham-RMT may not be an optimal control condition for RMT in LOPD.",2020,The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160).,"['late-onset Pompe disease (LOPD', 'late-onset Pompe disease', '22 adults with LOPD']","['Respiratory muscle training', 'respiratory muscle training (RMT) program', 'RMT or sham-RMT']","['daytime sleepiness', 'time to climb 4 steps', 'maximum inspiratory pressure (MIP', 'MEP', 'MIP and MEP', 'MIP', 'maximum expiratory pressure (MEP), peak cough flow, diaphragm ultrasound, polysomnography, patient-reported outcomes, and measures of gross motor function']","[{'cui': 'C0342753', 'cui_str': 'Glycogen storage disease due to acid maltase deficiency, late-onset'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}]",22.0,0.13199,The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160).,"[{'ForeName': 'Harrison N', 'Initials': 'HN', 'LastName': 'Jones', 'Affiliation': 'Department of Head and Neck Surgery & Communication Sciences, Duke University School of Medicine, 155 Baker House, Trent Dr., DUMC 3887, Durham, NC 27710, USA; Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA. Electronic address: harrison.jones@duke.edu.'}, {'ForeName': 'Maragatha', 'Initials': 'M', 'LastName': 'Kuchibhatla', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Crisp', 'Affiliation': 'Department of Head and Neck Surgery & Communication Sciences, Duke University School of Medicine, 155 Baker House, Trent Dr., DUMC 3887, Durham, NC 27710, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Hobson-Webb', 'Affiliation': 'Department of Neurology, Neuromuscular Division, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Case', 'Affiliation': 'Division of Physical Therapy, Duke University School Of Medicine, Durham, NC, USA.'}, {'ForeName': 'Milisa T', 'Initials': 'MT', 'LastName': 'Batten', 'Affiliation': 'Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marcus', 'Affiliation': 'Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Kravitz', 'Affiliation': 'Division of Pediatric Pulmonary and Sleep Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, Duke University School of Medicine, Durham, NC, USA.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.09.023']
2266,33127365,Discontinuing Nasal Continuous Positive Airway Pressure in Infants ≤32 Weeks Gestational Age: A Randomized Control Trial.,"OBJECTIVES


To compare immediate cessation of nasal continuous positive airway pressure (NCPAP) vs. a stepwise decrease in pressure on the duration of NCPAP therapy in infants born prematurely.
STUDY DESIGN


A single center study in infants 23 0 -32 6  weeks gestational age (GA). NCPAP was stopped either at 5cm H 2 O (Control) or 3cm H 2 O after a stepwise pressure wean (Wean) using defined stability and failure criteria. Primary outcome is total NCPAP days.
RESULTS


We enrolled 226 infants; 116 were randomly assigned to Control and 110 to the Wean group. There was no difference in the total NCPAP days between groups (median (25 th ,75 th  centiles) 16 (5,36) vs 14 (7,33) respectively). There were no differences between groups in secondary outcomes, including duration of hospital stay, critical care days and oxygen supplementation. A higher proportion of Control infants failed the initial attempt to discontinue NCPAP (43% versus 27%, respectively; P < .01) and required ≥2 attempts (20% versus 5%, respectively; P<0.01). Additionally, infants 23-27weeks GA in the Wean group were 2.4-times more likely to successfully stop NCPAP at the first attempt (P=0.02) versus Controls.
CONCLUSION


Discontinuation of NCPAP after a gradual pressure wean to 3cm H 2 O did not decrease the duration of NCPAP therapy compared with stopping from 5 cm H 2 O in infants ≤32 weeks GA. However, weaning decreased failed initial attempts to stop NCPAP, particularly among infants <28 week GA.",2020,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th  centiles) 16 (5,36) vs 14 (7,33) respectively).","['We enrolled 226 infants; 116', 'infants 23 0 -32 6  weeks gestational age (GA', 'Weeks Gestational Age', 'infants born prematurely', 'Infants ≤32']","['NCPAP', 'nasal continuous positive airway pressure (NCPAP', 'Discontinuing Nasal Continuous Positive Airway Pressure']","['duration of hospital stay, critical care days and oxygen supplementation', 'duration of NCPAP therapy', 'total NCPAP days']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",226.0,0.0528342,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th  centiles) 16 (5,36) vs 14 (7,33) respectively).","[{'ForeName': 'Venkatakrishna', 'Initials': 'V', 'LastName': 'Kakkilaya', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Sheron', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Parkland Hospital and Health Systems, Dallas, Texas.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ridpath', 'Affiliation': 'Parkland Hospital and Health Systems, Dallas, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'L Steven', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Parkland Hospital and Health Systems, Dallas, Texas.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rosenfeld', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.045']
2267,33127414,"Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China.","BACKGROUND


Drug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases.
OBJECTIVE


To evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon.
METHODS


This was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China,. The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events(MAE)rate at 12 months.
RESULTS


Between July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group (n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE 4  in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05).
CONCLUSION


Reewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.",2020,"The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001).","['patients with femoropopliteal artery lesions in China', 'The mean age of the subjects was 67.8\u202f±\u202f9.2\u202fyears in the DCB group (n\u202f=\u202f100) and 69.4\u202f±\u202f10.3\u202fyears in the PTA group (n\u202f=\u202f100', 'Between July 2014 and April 2017, a total of 200 patients were enrolled']","['plain balloon', 'Reewarm™ PTX drug-coated balloon', 'percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA', 'Drug-coated balloons (DCB', 'Reewarm™ PTX DCB']","['efficacy and safety', 'target lesion revascularization (TLR) and major advance events(MAE)rate at 12\u202fmonths', 'late lumen loss (LLL', 'TLR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",200.0,0.0611449,"The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Vascular Surgery, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiangchen', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Department of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of vascular surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhaoyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': ""Mi'er"", 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': ""Department of Vascular Surgery, Shanghai the Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China. Electronic address: liucw@vip.sina.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.060']
2268,33128036,Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial.,"BACKGROUND


As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone.
METHODS


In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters.
RESULTS


From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks.
CONCLUSIONS


A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.",2020,P < 0.001) after 12 weeks and -1.8 kg,"['patients with overweight or obesity and accompanied cardiovascular risk factors', 'multicenter RCT 463 participants with overweight or obesity (BMI: 27-35\u2009kg/m²; at least one additional co-morbidity of the metabolic syndrome', 'patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial', '101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up']","['Meal replacement by formula diet', 'control group with lifestyle intervention only (CON, n\u2009=\u2009155) or a lifestyle intervention group including a liquid meal replacement', 'telemonitoring devices (scales and pedometers), received information on healthy diet']","['cardiovascular risk factors', 'weight change', 'changes in cardiometabolic risk factors including body composition and laboratory parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",463.0,0.0479771,P < 0.001) after 12 weeks and -1.8 kg,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Halle', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany. martin.roehling@vkkd-kliniken.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute for Sports and Sport Science, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Klaus Michael', 'Initials': 'KM', 'LastName': 'Braumann', 'Affiliation': 'Faculty of Psychology and Human Movement Sciences, Department of Sports and Movement Medicine, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Public Health Nutrition Research Group, London Metropolitan University, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schaller', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany.'}, {'ForeName': 'Hans Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scholze', 'Affiliation': 'KARDIOS, Cardiologists in Berlin, Berlin, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Führer-Sakel', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism and Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Toplak', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical nutrition,['10.1038/s41430-020-00783-4']
2269,33128066,Disseminated Effects in Agent Based Models: A Potential Outcomes Framework and Application to Inform Pre-Exposure Prophylaxis Coverage Levels for HIV Prevention.,"Pre-exposure prophylaxis (PrEP) for HIV prevention may not only benefit the individual who uses it, but also their uninfected sexual risk contacts. We developed an agent-based model using a novel trial emulation approach to quantify disseminated effects of PrEP use among men who have sex with men in Atlanta, USA from 2015 to 2017. Components (subsets of agents connected through partnerships in a sexual network, but not sharing partnerships with any other agents) were first randomized to an intervention coverage level or control, then within intervention components, eligible agents were randomized to PrEP. We estimated direct and disseminated (indirect) effects using randomization-based estimators and reported corresponding 95% simulation intervals across scenarios ranging from 10% to 90% coverage in the intervention components. A population of 11,245 agents was simulated with an average of 1,551 components identified. Comparing agents randomized to PrEP in 70% coverage components to control agents, there was a 15% disseminated risk reduction in HIV incidence (95% simulation intervals = 0.65, 1.05). Individuals not on PrEP may receive a protective benefit by being in a sexual network with higher PrEP coverage. Agent-based models are useful to evaluate possible direct and disseminated effects of HIV prevention modalities in sexual networks.",2020,"Comparing agents randomized to PrEP in 70% coverage components to control agents, there was a 15% disseminated risk reduction in HIV incidence (95% simulation intervals = 0.65, 1.05).","['men who have sex with men in Atlanta, USA from 2015 to 2017']","['Pre-exposure prophylaxis (PrEP', 'PrEP']",['HIV incidence'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0208329,"Comparing agents randomized to PrEP in 70% coverage components to control agents, there was a 15% disseminated risk reduction in HIV incidence (95% simulation intervals = 0.65, 1.05).","[{'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bessey', 'Affiliation': 'Department of Epidemiology, Brown School of Public Health, Providence, RI.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown School of Public Health, Providence, RI.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology, Brown School of Public Health, Providence, RI.'}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Murray', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, MA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Department of Population Health, School of Medicine, New York University, New York, NY.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, and Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown School of Public Health, Providence, RI.'}]",American journal of epidemiology,['10.1093/aje/kwaa239']
2270,33128132,"Use of an anti-reflux catheter to improve tumor targeting for holmium-166 radioembolization-a prospective, within-patient randomized study.","PURPOSE


The objective of this study was to investigate whether the use of an anti-reflux catheter improves tumor targeting for colorectal cancer patients with unresectable, chemorefractory liver metastases (mCRC) treated with holmium-166 ( 166 Ho)-radioembolization.
MATERIALS AND METHODS


In this perspective, within-patient randomized study, left and right hepatic perfusion territories were randomized between infusion with a Surefire® anti-reflux catheter or a standard microcatheter. The primary outcome was the difference in tumor to non-tumor (T/N) activity distribution. Secondary outcomes included the difference in infusion efficiency, absorbed doses, predictive value of  166 Ho-scout, dose-response relation, and survival.
RESULTS


Twenty-one patients were treated in this study (the intended number of patients was 25). The median T/N activity concentration ratio with the use of the anti-reflux catheter was 3.2 (range 0.9-8.7) versus 3.6 (range 0.8-13.3) with a standard microcatheter. There was no difference in infusion efficiency (0.04% vs. 0.03% residual activity for the standard microcatheter and anti-reflux catheter, respectively) (95%CI - 0.05-0.03). No influence of the anti-reflux catheter on the dose-response rate was found. Median overall survival was 7.8 months (95%CI 6-13).
CONCLUSION


Using a Surefire® anti-reflux catheter did not result in a higher T/N activity concentration ratio in mCRC patients treated with  166 Ho-radioembolization, nor did it result in improved secondary outcomes measures.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT02208804.",2020,"There was no difference in infusion efficiency (0.04% vs. 0.03% residual activity for the standard microcatheter and anti-reflux catheter, respectively)","['colorectal cancer patients with unresectable, chemorefractory liver metastases (mCRC) treated with holmium-166 ( 166 Ho)-radioembolization', 'left and right hepatic perfusion territories']","['anti-reflux catheter', 'Surefire® anti-reflux catheter or a standard microcatheter']","['infusion efficiency', 'difference in tumor to non-tumor (T/N) activity distribution', 'higher T/N activity concentration ratio', 'median T/N activity concentration ratio', 'Median overall survival', 'infusion efficiency, absorbed doses, predictive value of  166 Ho-scout, dose-response relation, and survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1512482', 'cui_str': 'Holmium-166'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",21.0,0.173881,"There was no difference in infusion efficiency (0.04% vs. 0.03% residual activity for the standard microcatheter and anti-reflux catheter, respectively)","[{'ForeName': 'Caren', 'Initials': 'C', 'LastName': 'van Roekel', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. j.vanroekel@umcutrecht.nl.'}, {'ForeName': 'Andor F', 'Initials': 'AF', 'LastName': 'van den Hoven', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Bastiaannet', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Rutger C G', 'Initials': 'RCG', 'LastName': 'Bruijnen', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Arthur J A T', 'Initials': 'AJAT', 'LastName': 'Braat', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Keizer', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Marnix G E H', 'Initials': 'MGEH', 'LastName': 'Lam', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Maarten L J', 'Initials': 'MLJ', 'LastName': 'Smits', 'Affiliation': 'University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-05079-0']
2271,33128138,A comparative prospective study between stemmed versus an unstemmed tibial component in total knee arthroplasty in obese patients.,"BACKGROUND


There is no consensus in the literature regarding the patients with obesity who do well with TKA, or this group is at risk of a variety of complications. Implant choices between the two types of implants which either long or standard stem can improve the likelihood that a patient with obesity will achieve high scores for function and quality of life after TKA.
METHODS


This prospective clinical study included 200 patients who were categorized into two groups: group (1) traditional (standard) unstemmed cemented tibial tray (n = 100 patients) and group (2) stemmed cemented tibial tray with the cementless press-fit stem (n = 100 patients).
RESULTS


The average follow-up was (7.6 ± 1 years) (range from 6.5 up to 10 years). The average age of the stemmed group was 55.69 ± 8.45 and for the unstemmed group was 57.3 ± 7.8. The average BMI for the stemmed patients was 38.84 ± 3.89, while for the standard (unstemmed) group was 40.0 ± 3.95. Functional results showed significant improvement in both groups but more in the stemmed group (LS) as the difference and change between pre and post were more significant at long stem (P > 0.001).
CONCLUSION


Based on our results, there were significant improvements in both groups either stemmed or unstemmed TKA but more in the stemmed group which had higher functional outcomes compared to the unstemmed group.
LEVEL OF EVIDENCE


IV.",2020,", there were significant improvements in both groups either stemmed or unstemmed TKA","['n\u2009=\u2009100 patients', 'total knee arthroplasty in obese patients', '200 patients who were categorized into two groups: group (1', 'patients with obesity who do well with']","['traditional (standard) unstemmed cemented tibial tray (n\u2009=\u2009100 patients) and group (2) stemmed cemented tibial tray with the cementless press-fit stem', 'unstemmed tibial component', 'TKA']","['functional outcomes', 'average BMI']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0211977,", there were significant improvements in both groups either stemmed or unstemmed TKA","[{'ForeName': 'Mohamed Mansour', 'Initials': 'MM', 'LastName': 'Elzohairy', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt. elzohairy.me@gmail.com.'}, {'ForeName': 'Sherif Mohamed', 'Initials': 'SM', 'LastName': 'Elaidy', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt.'}, {'ForeName': 'Mohamed Elsadek', 'Initials': 'ME', 'LastName': 'Attia', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02816-x']
2272,33128206,"Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial.","BACKGROUND AND AIM


Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients.
METHODS


596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108.
RESULTS


The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week.
CONCLUSION


Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile.
CLINICAL TRIAL NUMBER


ChiCTR-TRC-12002784 (Chinese Clinical Trial Registry).",2020,"The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week.
","['eligible participants', 'HBeAg-positive chronic hepatitis B patients', 'Chinese patients', '596']","['Traditional Chinese medicine (TCM', 'entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD', 'TCM placebo', 'placebo', 'Entecavir combining Chinese herbal medicine', 'ETV plus the TCM formula']","['superior HBeAg loss', 'hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT', 'rate of HBeAg loss', 'superior HBeAg clearance', 'therapeutic effect and safety profile', 'DNA loss rate, serum HBsAg level, and liver enzymes', 'rate of hepatitis B e antigen (HBeAg) loss']","[{'cui': 'C0392390', 'cui_str': 'Hepatitis B e antigen positive'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0061008', 'cui_str': 'gallium nitrate'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement'}]",596.0,0.380961,"The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week.
","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Daqiao', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatology, Shenzhen TCM Hospital, No. 1 Fuhua Road, Futian District, Shenzhen, 518033, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Department of Hepatology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Dade Road 111, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, No. 312 Xihong road, Gulou District, Fujian, 350025, Fuzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, Public Health Clinical Center of Chengdu, No. 377 Jingming Road, Jinjiang District, Chengdu, 610066, Sichuan, China.'}, {'ForeName': 'Bingjiu', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatology, Liaoning Hospital of TCM, Huanggu District, No. 33, Beiling Street, Shenyang, 110032, Liaoning, China.'}, {'ForeName': 'Dewen', 'Initials': 'D', 'LastName': 'Mao', 'Affiliation': 'Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, No. 89-9, Dongge road, Nanning, 530023, Guangxi, China.'}, {'ForeName': 'Qikai', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Hepatology, The Third People's Hospital of Shenzhen, No. 29 Bujibulan Road, Longgang District, Shenzhen, 518112, China.""}, {'ForeName': 'Xianbo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, Beijing Ditan Hospital, No. 8 Jingshun East Road, Chaoyang District, Beijing, 100015, China.'}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatology, The Sixth People's Hospital of Shenyang, No. 85 Heping south road, Heping District, Shenyang, 110006, Liaoning, China.""}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': ""Department of Hepatology, Shaanxi Hospital of TCM, No. 4 Xihuamen, Lianhu District, Xi'an, 710003, Shaanxi, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, The Affiliated Hospital of Shandong University of TCM, No. 42 Wenhua West Road, Jinan, 250011, Shandong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Hepatology, Tianjin Second People's Hospital, No.7 Sudi South Road, Nankai District, Tianjin, 300192, China.""}, {'ForeName': 'Jianchun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Hepatology, Xixi Hospital of Hangzhou, No. 2 Hengbu road, Liuxiazhen, Xihu District, Hangzhou, 310023, Zhejiang, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Liver Disease, Fifth Medical Center of Chinese PLA General Hospital, No.100 West Fourth Ring Road, Beijing, 100039, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Xianzhao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Hepatology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 An Shan Xi Road, Nan Kai District, Tianjin, 300193, China.'}, {'ForeName': 'Danan', 'Initials': 'D', 'LastName': 'Gan', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, No. 16, Dongzhimen South Street, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, No. 16, Dongzhimen South Street, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. duhongbo@bucm.edu.cn.'}, {'ForeName': ""Yong'an"", 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. yeyongan@vip.163.com.'}]",Hepatology international,['10.1007/s12072-020-10097-z']
2273,33126931,A public health approach to increase treatment of latent TB among household contacts in Brazil.,"SETTING:  Two consecutive trials were conducted to evaluate the effectiveness of a public health approach to identify and correct problems in the care cascade for household contacts (HHCs) of TB patients in three Brazilian high TB incidence cities. METHODS:  In the first trial, 12 clinics underwent standardised evaluation using questionnaires administered to TB patients, HHCs and healthcare workers, and analysis of the cascade of latent TB care among HHCs. Six clinics were then randomised to receive interventions to strengthen management of latent TB infection (LTBI), including in-service training provided by nurses, work process organisation and additional clinic-specific solutions. In the second trial, a similar but streamlined evaluation was conducted in two clinics, who then received initial and subsequent intensive in-service training provided by a physician. RESULTS:  In the evaluation phase of both trials, many HHCs were identified, but few started LTBI treatment. After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial. DISCUSSION:  A public health approach with standardised evaluation, local decisions for improvements, followed by intensive initial and in-service training appears promising for improved LTBI management.",2020,"After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial.","['TB patients in three Brazilian high TB incidence cities', 'latent TB among household contacts in Brazil']","['public health approach', 'interventions to strengthen management of latent TB infection (LTBI), including in-service training provided by nurses, work process organisation and additional clinic-specific solutions']",['number of HHCs initiating treatment'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1833213', 'cui_str': 'Hyperferritinemia cataract syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",12.0,0.081285,"After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial.","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bastos', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil, Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Oxlade', 'Affiliation': 'McGill International TB Centre.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit, Departments of Epidemiology, Biostatistics & Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fregonese', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Valiquette', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'S C C', 'Initials': 'SCC', 'LastName': 'Lira', 'Affiliation': 'Recife Municipal Health Secretariat, Recife, PE, Programa de Pós-graduação em Saúde Coletiva, Universidade Federal do Pernambuco, Recife, PE.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carvalho-Cordeiro', 'Affiliation': 'Manaus Municipal Health Secretariat, Manaus, AM, Programa de Pós-gradução em Enfermagem, Universidade Federal do Amazonas, Manaus, AM.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Cavalcante', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Faerstein', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'M F M', 'Initials': 'MFM', 'LastName': 'Albuquerque', 'Affiliation': 'Aggeu Magalhães Research Center, Fiocruz, Recife, PE.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cordeiro-Santos', 'Affiliation': 'Tropical Medicine Post-Graduation Program, Amazonas State University, Manaus, AM, Tropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, AM, Brazil.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'Centre for International Health, Otago Medical School, University of Otago, Otago, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit, McGill International TB Centre, Departments of Epidemiology, Biostatistics & Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'McGill International TB Centre, Internal Medicine Post-Graduation Program, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Primary Health Care Post-Graduation Program, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0728']
2274,33127015,Cost-Effectiveness of Immediate Magnetic Resonance Imaging In the Management of Patients With Suspected Scaphoid Fracture: Results From a Randomized Clinical Trial.,"OBJECTIVES


Given the limited diagnostic accuracy of radiographs on presentation to the emergency department (ED), the management of suspected scaphoid fractures remains clinically challenging and poses an unknown economic burden to healthcare systems. We aimed to evaluate the cost-effectiveness of immediate magnetic resonance imaging (MRI) in the management of patients presenting with suspected scaphoid fracture to an ED in England.
METHODS


A pragmatic, randomized, single-center trial compared the use of immediate MRI in the ED against standard care with radiographs only. Participants' use of healthcare services and costs were estimated from primary care and secondary care databases and questionnaires at baseline, 1, 3, and 6 months postrecruitment. Costs were compared using generalized linear models and combined with quality-adjusted life years (QALYs, based on the EQ-5D-5L) to estimate cost-effectiveness at 6 months postrecruitment. Cost-effectiveness acceptability curves and bootstrapping techniques were used to estimate the probability of cost-effectiveness at different willingness-to-pay (WTP) thresholds. Four deterministic sensitivity scenarios were considered around key parameters.
RESULTS


The MRI intervention dominated standard care in the base case and all 4 deterministic sensitivity scenarios, costing less and achieving more QALY gains, with a probability of 100% of being cost-effective at 6 months using the conventional United Kingdom WTP thresholds of £20 000 to £30 000 per QALY.
CONCLUSION


The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London. Routine clinical practice at our institution has been changed to include the intervention.",2020,The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London.,"['suspected scaphoid fractures in a Central Hospital in London', 'Patients With Suspected Scaphoid Fracture', 'patients presenting with suspected scaphoid fracture to an ED in England']","['Immediate Magnetic Resonance Imaging', 'immediate MRI', 'immediate magnetic resonance imaging (MRI']","['cost-effectiveness', 'probability of cost-effectiveness']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0872574,The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London.,"[{'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Rua', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK; Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK. Electronic address: tiago.rua@kcl.ac.uk.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Gidwani', 'Affiliation': ""Department of Orthopaedics, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Malhotra', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Vijayanathan', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunter', 'Affiliation': ""Emergency Department, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, England, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Turville', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razavi', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK; Vice President & Vice-Principal (Research), King's College London, London, England, UK.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Goh', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK; Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, London, England, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK.""}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.05.020']
2275,33127212,Evaluation of the effectiveness of dexamethasone iontophoresis in patients with subacromial impingement syndrome.,"BACKGROUND


Subacromial impingement syndrome is the most common shoulder disease in individuals. There is no study evaluating the effectiveness of steroid iontophoresis in subacromial impingement syndrome. We aimed to assess the effectiveness of dexamethasone iontophoresis as treatment for impingement syndrome with respect to pain and function.
METHODS


Forty-six patients with subacromial impingement syndrome were recruited to the study and divided randomly into two groups (21 patients in iontophoresis group and 25 patients in control group). Demographic, clinical features and MRI findings of patients were recorded. Detailed physical examination of all patients were performed and Numerical rating scale (NRS) during rest and exercise, The Disabilities of the Arm, Shoulder and Hand (DASH) scores were recorded at baseline, week 2 and week 6. Both group received physiotherapy program for ten days. Additionally the patients in iontophoresis group recieved dexamethasone iontophoresis (1 mg dexamethasone per 1 g administered under the active electrode) with an intensity of 0.1-0.2 mA/cm2 galvanic current for ten days.
RESULTS


No significant difference was observed between the groups in terms of gender, job status, MRI findings, painful shoulder and pain duration. Baseline range of motion, Neer, Hawkins, Yocum and painful arc tests, numerical rating scale (NRS) and DASH scores were similar between groups. A significant improvement was found in terms of the NRS (resting and exercise) and DASH scores at week 2 and week 6 in both group (p < 0.001). A significant difference was found in terms of improvement NRS (resting) and DASH scores between baseline and week 6 in iontophoresis group (p = 0.007, p = 0.011 respectively).
CONCLUSIONS


Adding dexamethasone iontophoresis to physiotherapy for patients with subacromial impingement syndrome seems to provide a better clinical and functional improvement.",2020,"No significant difference was observed between the groups in terms of gender, job status, MRI findings, painful shoulder and pain duration.","['impingement syndrome with respect to pain and function', 'subacromial impingement syndrome', 'individuals', 'Forty-six patients with subacromial impingement syndrome', 'patients with subacromial impingement syndrome']","['iontophoresis', 'dexamethasone iontophoresis', 'dexamethasone', 'dexamethasone iontophoresis to physiotherapy', 'steroid iontophoresis', 'physiotherapy program']","['gender, job status, MRI findings, painful shoulder and pain duration', 'Numerical rating scale (NRS) during rest and exercise, The Disabilities of the Arm, Shoulder and Hand (DASH) scores', 'improvement NRS (resting) and DASH scores', 'Baseline range of motion, Neer, Hawkins, Yocum and painful arc tests, numerical rating scale (NRS) and DASH scores', 'NRS (resting and exercise) and DASH scores']","[{'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0014006', 'cui_str': 'Occupational Status'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",46.0,0.0376332,"No significant difference was observed between the groups in terms of gender, job status, MRI findings, painful shoulder and pain duration.","[{'ForeName': 'Dilek Eker', 'Initials': 'DE', 'LastName': 'Buyuksireci', 'Affiliation': 'Hitit University Erol Olcok Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Corum, Turkey. Electronic address: dilekeker55@gmail.com.'}, {'ForeName': 'Ayla Cagliyan', 'Initials': 'AC', 'LastName': 'Turk', 'Affiliation': 'Hitit University Erol Olcok Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Corum, Turkey. Electronic address: drayla1976@hotmail.com.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.09.007']
2276,33127241,The Mediating Effect of School Climate on Adolescent Mental Health: Findings From a Randomized Controlled Trial of a School-Wide Intervention.,"PURPOSE


Adolescence encompasses a critical developmental phase, which fosters or hinders psychological, physical, and social health. Whole-school interventions take a universal approach in targeting the entire school environment (""school climate"") to improve adolescent outcomes; however, little is known about the mediating role of school climate on these effects.
METHODS


Our study (N = 5,539) was situated within the Strengthening Evidence base on scHool-based intErventions for pRomoting randomized controlled trial, which demonstrated the effectiveness of a lay counselor-delivered school intervention among secondary school students in Bihar, India. We examined the potential mediating role of school climate and its subcomponents (relationships at school, sense of belonging, commitment to academic achievement, and participation in school events) at 8 months postrandomization of the Strengthening Evidence base on scHool-based intErventions for pRomoting intervention on longer term adolescent health outcomes (depressive symptoms, experiences of bullying, and perpetration of violence) at 17 months postrandomization. The trial was registered with ClinicalTrials.gov (NCT02484014).
RESULTS


School climate mediated the effects of the intervention on all three outcomes of interest. A nurturing school environment, characterized by supportive and engaged relationships with teachers and peers, a sense of belonging, and active participation in school climate predicted lower rates of depressive symptoms, experiences of bullying, and perpetration of violence. Noteworthy, it was the quality of these relationships, rather than the commitment to learning, which was most predictive of outcomes.
CONCLUSION


Educational policies should consider bolstering the school's social environment to directly impact adolescent health and well-being.",2020,"Noteworthy, it was the quality of these relationships, rather than the commitment to learning, which was most predictive of outcomes.
","['Adolescent Mental Health', 'secondary school students in Bihar, India']","['School-Wide Intervention', 'School Climate', 'lay counselor-delivered school intervention']","['depressive symptoms, experiences of bullying, and perpetration of violence', 'longer term adolescent health outcomes (depressive symptoms, experiences of bullying, and perpetration of violence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0376207,"Noteworthy, it was the quality of these relationships, rather than the commitment to learning, which was most predictive of outcomes.
","[{'ForeName': 'Daisy R', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Department of Psychiatry, Sinai Health System, University of Toronto, Toronto, Ontario, Canada. Electronic address: daisy.singla@utoronto.ca.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Patton', 'Affiliation': ""Murdoch Children's Research Institute, University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Sangath, Porvorim, Goa, India; Department of Global Health and Social Medicine, Harvard Medical School, Cambridge, Massachusetts.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.09.030']
2277,33127571,Quality of Life of Patients with Unruptured Intracranial Aneurysms Before and After Endovascular Coiling: A HEAT Trial Secondary Study and Systematic Review of the Literature.,"INTRODUCTION


The study of quality of life (QOL) in patients with asymptomatic diseases receiving interventional treatment provides an essential metric for the assessment of procedural benefits in the surgical patient population. In this study, we analyzed quality of life data collected from patients with unruptured brain aneurysms (UIA) before and after endovascular coiling in the HEAT Trial, alongside a systematic review on QOL in unruptured brain aneurysms.
METHODS


HEAT was a randomized controlled trial comparing recurrence rates in aneurysms treated with either bare platinum coils or hydrogel coils. Patients enrolled in this trial completed a short form 36 (SF-36) QOL questionnaire prior to treatment and at the 3-12 and 18-24-month follow-ups. The change in QOL before and after treatment was assessed. Regression analysis evaluated the effect of select baseline characteristics on QOL change.
RESULTS


A total of 270 patients were eligible for analysis. There was an increase in the role physical (p=0.043), vitality (p=0.022), and emotional well-being (p<0.001) QOL components at the 18-24-month follow-up compared to baseline scores. Regression analysis showed that age<60 and absence of serious adverse events were associated with improved social functioning and vitality. The literature review showed a mixed effect of intervention on QOL in patients with UIAs.
CONCLUSION


Our analysis has revealed that patients with 3-14 mm UIAs had improvements in some physical and emotional components of QOL at 18-24 months following aneurysm coiling in the HEAT study. The literature remains indeterminate on this issue. Further studies are needed to better understand the effects of the diagnosis of UIAs and their treatment on QOL.",2020,"There was an increase in the role physical (p=0.043), vitality (p=0.022), and emotional well-being (p<0.001) QOL components at the 18-24-month follow-up compared to baseline scores.","['270 patients were eligible for analysis', 'patients with UIAs', 'Patients with Unruptured Intracranial Aneurysms Before and After Endovascular Coiling', 'Patients enrolled in this trial completed a short form 36 (SF-36) QOL questionnaire prior to treatment and at the 3-12 and 18-24-month follow-ups', 'surgical patient population', 'patients with unruptured brain aneurysms (UIA) before and after endovascular coiling in the HEAT Trial', 'patients with asymptomatic diseases receiving']","['bare platinum coils or hydrogel coils', 'interventional treatment']","['vitality (p=0.022), and emotional well-being (p<0.001) QOL components', 'role physical', 'Quality of Life', 'quality of life (QOL', 'recurrence rates', 'QOL change', 'physical and emotional components of QOL', 'social functioning and vitality', 'change in QOL']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0751003', 'cui_str': 'Brain Aneurysm'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C2936329', 'cui_str': 'Pre-Symptomatic Diseases'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",270.0,0.0638852,"There was an increase in the role physical (p=0.043), vitality (p=0.022), and emotional well-being (p<0.001) QOL components at the 18-24-month follow-up compared to baseline scores.","[{'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Abi-Aad', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Rudy J', 'Initials': 'RJ', 'LastName': 'Rahme', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Syal', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Devi P', 'Initials': 'DP', 'LastName': 'Patra', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Richter', 'Affiliation': 'Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Mayo Clinic Alix School of Medicine, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Ward', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, IL.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kniss', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, IL.'}, {'ForeName': 'Yak', 'Initials': 'Y', 'LastName': 'Nak', 'Affiliation': 'Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Turcotte', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Welz', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'JoDee', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Krishna', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Department of Radiology, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bendok', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, AZ; Department of Otolaryngology, Mayo Clinic, Phoenix, AZ; Department of Radiology, Mayo Clinic, Phoenix, AZ; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, AZ; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, AZ. Electronic address: Bendok.bernard@gmail.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.120']
2278,33127579,"Sonication of the Anterior Thalamus with MRI-Guided Transcranial Focused Ultrasound (tFUS) Alters Pain Thresholds in Healthy Adults: A Double-Blind, Sham-Controlled Study.","BACKGROUND


Transcranial focused ultrasound (tFUS) is a noninvasive brain stimulation method that may modulate deep brain structures. This study investigates whether sonication of the right anterior thalamus would modulate thermal pain thresholds in healthy individuals.
METHODS


We enrolled 19 healthy individuals in this three-visit, double-blind, sham-controlled, crossover trial. Participants first underwent a structural MRI scan used solely for tFUS targeting. They then attended two identical experimental tFUS visits (counterbalanced by condition) at least one week apart. Within the MRI scanner, participants received two, 10-minute sessions of either active or sham tFUS spread 10 minutes apart targeting the right anterior thalamus [fundamental frequency: 650kHz, Pulse repetition frequency: 10 Hz, Pulse Width: 5ms, Duty Cycle: 5%, Sonication Duration: 30s, Inter-Sonication Interval: 30 s, Number of Sonications: 10, ISPTA. 0  995 mW/cm2, ISPTA. 3  719 mW/cm2, Peak rarefactional pressure 0.72 MPa]. The primary outcome measure was quantitative sensory thresholding (QST), measuring sensory, pain, and tolerance thresholds to a thermal stimulus applied to the left forearm before and after right anterior thalamic tFUS.
RESULTS


The right anterior thalamus was accurately sonicated in 17 of the 19 subjects. Thermal pain sensitivity was significantly attenuated after active tFUS. The pre-post x active-sham interaction was significant (F(1,245.95)=4.03, p=.046). This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08ºC (SE=.28) pre-post session, but only decreased .51ºC (SE=.30) pre-post session in the active stimulation group.
CONCLUSIONS


Two 10-minute sessions of anterior thalamic tFUS induces antinociceptive effects in healthy individuals. Future studies should optimize the parameter space, dose and duration of this effect which may lead to multi-session tFUS interventions for pain disorders.",2020,"This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08ºC (SE=.28) pre-post session, but only decreased .51ºC","['Healthy Adults', '19 healthy individuals', 'healthy individuals']","['structural MRI scan', 'tFUS', 'active or sham tFUS spread 10 minutes apart targeting the right anterior thalamus [fundamental frequency: 650kHz, Pulse repetition frequency', 'MRI-Guided Transcranial Focused Ultrasound', 'Transcranial focused ultrasound (tFUS']","['right anterior thalamus', 'quantitative sensory thresholding (QST), measuring sensory, pain, and tolerance thresholds to a thermal stimulus applied to the left forearm before and after right anterior thalamic tFUS', 'Thermal pain sensitivity', 'antinociceptive effects', 'thermal pain thresholds']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",19.0,0.31872,"This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08ºC (SE=.28) pre-post session, but only decreased .51ºC","[{'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC. Electronic address: badran@musc.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Caulfield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Stomberg-Firestein', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Philipp M', 'Initials': 'PM', 'LastName': 'Summers', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Logan T', 'Initials': 'LT', 'LastName': 'Dowdle', 'Affiliation': 'Center for Magnetic Resonance Research, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Savoca', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Austelle', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Borckardt', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Spivak', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bystritsky', 'Affiliation': 'BrainSonix Corporation, Sherman Oaks, CA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC; Ralph H. Johnson VA Medical Center, Charleston, SC.'}]",Brain stimulation,['10.1016/j.brs.2020.10.007']
2279,33127581,Transcutaneous Auricular Vagus Nerve Stimulation Enhances Learning of Novel Letter-Sound Relationships in Adults.,"BACKGROUND


Reading is a critical skill in modern society but is significantly more difficult to acquire during adulthood. Many adults are required to learn a new orthography after this window closes for personal or vocational reasons and while many programs and training methods exist for learning to read in adulthood, none result in native-like fluency. Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
OBJECTIVE


The goal of the current study was to evaluate whether non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) is effective at enhancing novel orthography acquisition in young adults.
METHODS


We enrolled 37 typically developing participants and randomly assigned them to a computer control, device sham control, earlobe stimulation control, or experimental transcutaneous auricular stimulation (taVNS) group. Participants then learned novel letter-sound correspondences in Hebrew over five training lessons. Performance was assessed using three measures to evaluate various aspects of reading: Letter ID, Automaticity, and Decoding.
RESULTS


The taVNS group significantly outperformed the three control groups on both the Automaticity and Decoding tasks. There was no difference on the Letter ID task.
CONCLUSIONS


These results demonstrate, for the first time, that taVNS is capable of improving aspects of reading acquisition in adults. These findings have potential implications for a wide range of cognitive tasks.",2020,"Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
","['Adults', 'young adults']","['non-invasive transcutaneous auricular vagus nerve stimulation (taVNS', 'computer control, device sham control, earlobe stimulation control, or experimental transcutaneous auricular stimulation (taVNS) group', 'Transcutaneous Auricular Vagus Nerve Stimulation']","['reading: Letter ID, Automaticity, and Decoding', 'Letter ID task', 'Automaticity and Decoding tasks']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",37.0,0.0476777,"Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
","[{'ForeName': 'Vishal J', 'Initials': 'VJ', 'LastName': 'Thakkar', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129. Electronic address: vishalthakkar0415@gmail.com.'}, {'ForeName': 'Abby S', 'Initials': 'AS', 'LastName': 'Engelhart', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129. Electronic address: abby.mason@tcu.edu.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Khodaparast', 'Affiliation': 'Nexeon MedSystems, Inc., Dallas, TX, 75231. Electronic address: navid.khodaparast@sparkbiomedical.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Abadzi', 'Affiliation': 'Department of Psychology, University of Texas Arlington, Arlington, TX, 76019. Electronic address: habadzi@gmail.com.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Centanni', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129. Electronic address: tmcentanni@gmail.com.'}]",Brain stimulation,['10.1016/j.brs.2020.10.012']
2280,33127585,"Prior pain exposure and mere possession of a placebo analgesic predict placebo analgesia: Findings from a randomised, double-blinded, controlled trial.","A recent study found that merely possessing a placebo analgesic reduces pain. The current study tested for a possible moderator of this effect. Specifically, does the mere possession of a placebo analgesic affect pain for individuals with and without immediate prior experience with the pain task? Healthy participants (N=127) were randomized to prior pain (PP) condition or without prior pain (No-PP) condition. In the PP condition, participants first did a preliminary trial of a cold pressor test (CPT) to induce direct experience with this pain stimulus. Then they were randomized to possess an inert cream described as either an analgesic cream or an anti-itch cream (pain-irrelevant control object). Participants then completed the main CPT. In the No-PP condition, participants underwent identical procedures and randomization except that they did not do a preliminary CPT, thus having no immediate prior CPT pain experience. We found a significant prior pain experience and possession status interaction effect on placebo analgesia. Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream. Such mere possession effect was not found in the PP condition. The impact of expectancy and emotion on the underlying process are discussed. PERSPECTIVE: This article presents a novel finding that prior pain exposure and mere possession of a placebo analgesic predicted placebo analgesia. It offers a novel perspective on the time course of placebo effect. It provides practical implications on potential pain intervention for clinicians and paradigm design for researchers of placebo study.",2020,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,['Healthy participants (N=127'],"['cold pressor test (CPT', 'placebo analgesic predicted placebo analgesia', 'prior pain (PP) condition or without prior pain (No-PP) condition', 'placebo analgesic', 'analgesic cream or an anti-itch cream (pain-irrelevant control object']","['lower pain', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",127.0,0.337568,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,"[{'ForeName': 'Victoria Wai-Lan', 'Initials': 'VW', 'LastName': 'Yeung', 'Affiliation': 'Lingnan University, Hong Kong. Electronic address: vickiyeung@ln.edu.hk.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'University of Toledo, United States.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.10.004']
2281,33127948,A randomized controlled trial of resistance and balance exercise for sarcopenic patients aged 80-99 years.,"We compared a mixed exercise program (i.e., balance exercise plus resistance exercise) with resistance exercise in a single-blind, randomized controlled trial in a post-acute care unit. In total, 60 sarcopenic patients were randomly assigned to an intervention group (12-week mixed exercise) and a control group (12-week resistance exercise). The primary outcomes were the change of the Barthel Index and the number of fallers. The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4). The mixed exercise program provided a significant benefit over resistance exercise (adjusted mean difference of the change of Barthel Index: 6.8 points; 95% CI 1.4-12.1). The number of fallers was 13.3% and 23.3% in the intervention and control groups, respectively, but the difference was not significant (risk ratio (RR) 0.89, 95% CI 0.69-1.13, p = 0.506). In conclusion, compared with resistance exercise, the mixed exercise program appears to further improve the activities of daily living and physical performance in our study population. Under the monitoring of experienced physiotherapists, both exercise programs are feasible and safe for this population.",2020,"The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4).","['60 sarcopenic patients', 'sarcopenic patients aged 80-99\xa0years']","['control group (12-week resistance exercise', 'mixed exercise program', 'intervention group (12-week mixed exercise', 'resistance and balance exercise', 'resistance exercise, the mixed exercise program', 'mixed exercise program (i.e., balance exercise plus resistance exercise) with resistance exercise']","['number of fallers', 'change of the Barthel Index and the number of fallers', 'activities of daily living and physical performance', 'Barthel Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.176726,"The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4).","[{'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China. yangmier@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-75872-2']
2282,33127967,Preoperative communication with anesthetists via anesthesia service platform (ASP) helps alleviate patients' preoperative anxiety.,"Female gender has been identified as one of the risk factors closely linked to perioperative anxiety and a lower level of satisfaction. A successful preoperative anesthesia education may improve such negative outcomes. The aim of this study was to investigate whether preoperative anesthesia education via an Anesthesia Service Platform (ASP) could reduce the anxiety levels in female patients scheduled for laparoscopic cholecystectomy under general anesthesia, and accelerate rehabilitation. A total of 222 patients scheduled for elective laparoscopic cholecystectomy were randomly assigned to the control group and the ASP group. Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule. Pain management and recovery were assessed by VAS every 12 h for 48 h after surgery; length of stay (LOS) and postoperative analgesic consumption were also assessed. Patients in the control group experienced higher anxiety levels before surgery and had longer LOS than those in the ASP group. Patients in the ASP group had a higher general well-being score; however, they suffered more pain and consumed more analgesics after surgery. ASP is effective for preventing anxiety in female patients before laparoscopic cholecystectomy, improving patients' general well-being levels, and shortening their LOS, but negatively influences patients' postoperative pain levels.",2020,Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule.,"['female patients scheduled for laparoscopic cholecystectomy under general anesthesia, and accelerate rehabilitation', 'female patients before', '222 patients scheduled for elective laparoscopic cholecystectomy']","['laparoscopic cholecystectomy', 'ASP', 'Preoperative communication with anesthetists via anesthesia service platform (ASP', 'preoperative anesthesia education via an Anesthesia Service Platform (ASP']","['higher anxiety levels', 'anxiety levels', 'Pain management and recovery', 'length of stay (LOS) and postoperative analgesic consumption']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",222.0,0.02412,Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule.,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Qiange', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Meihan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Southwest Medical University, Luzhou, People's Republic of China.""}, {'ForeName': 'Guangxiang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Maohua', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China. wangmaohua@swmu.edu.cn.""}]",Scientific reports,['10.1038/s41598-020-74697-3']
2283,33127971,Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial.,"Oxidative stress (OS) is associated with poor oocyte quality and in vitro fertilization and embryo transfer (IVF-ET) outcomes for patients with polycystic ovary syndrome (PCOS). Growth hormone (GH) can function to reduce OS in some types of cells. Therefore, this prospective randomized study investigated whether GH can significantly improve OS and oocyte quality in women with PCOS. This study enrolled 109 and 50 patients with and without PCOS (controls), respectively. The patients with PCOS were randomly assigned to receive treatment with GH (PCOS-T) or not (PCOS-C). The primary outcome included markers of OS in serum and FF, and secondary outcomes were mitochondrial function in granulosa cells (GCs) and IVF-ET outcomes. The PCOS groups showed higher basal serum total oxidant status (TOS) and OS index (OSI) levels. The follicle fluid (FF) TOS and OSI and GC apoptosis rate were significantly higher, whereas the GC mitochondrial membrane potential (MMP) was significantly lower in the PCOS-C group than in the PCOS-T and non-PCOS control groups (P < 0.05). Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05). GH also improved the rates of implantation and clinical pregnancy, but not significantly (P > 0.05). This study showed that GH alleviated the TOS and OSI level in FF and improved GC mitochondrial dysfunction and oocyte quality in patients with PCOS.Clinical Trial Registration Number: This project was prospectively registered on the Chinese Clinical Trial Registry on October 20, 2018. (ChiCTR1800019437) ( https://www.chictr.org.cn/edit.aspx?pid=28663&htm=4 ).",2020,Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05).,"['patients with polycystic ovary syndrome (PCOS', 'Chinese women with polycystic ovary syndrome', 'enrolled 109 and 50 patients with and without PCOS (controls), respectively', 'patients with PCOS', 'patients with PCOS.Clinical Trial Registration Number: This project was prospectively registered on the Chinese Clinical Trial Registry on October 20, 2018', 'women with PCOS']","['GH (PCOS-T) or not (PCOS-C', 'GH', 'Growth hormone alleviates oxidative stress', 'Growth hormone (GH']","['TOS and OSI level', 'rates of implantation and clinical pregnancy', 'basal serum total oxidant status (TOS) and OS index (OSI) levels', 'fertilised and cleavage stage embryos', 'GC mitochondrial dysfunction and oocyte quality', 'GC mitochondrial membrane potential (MMP', 'markers of OS in serum and FF, and secondary outcomes were mitochondrial function in granulosa cells (GCs) and IVF-ET outcomes', 'oocyte quality', 'follicle fluid (FF) TOS and OSI and GC apoptosis rate', 'Oxidative stress (OS', 'OS and oocyte quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0025251', 'cui_str': 'Transmembrane Potentials'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",,0.180794,Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Deng', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Quan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China. Weihuang64@163.com.""}]",Scientific reports,['10.1038/s41598-020-75107-4']
2284,33127993,Lithium modulates striatal reward anticipation and prediction error coding in healthy volunteers.,"Lithium is one of the most effective mood-stabilizing medications in bipolar disorder. This study was designed to test whether lithium administration may stabilize mood via effects on reward processing. It was hypothesized that lithium administration would modulate reward processing in the striatum and affect both anticipation and outcome computations. Thirty-seven healthy human participants (18 males, 33 with suitable fMRI data) received 11 (±1) days of lithium carbonate or placebo intervention (double-blind), after which they completed the monetary incentive delay task while fMRI data were collected. The monetary incentive delay task is a robust task with excellent test-retest reliability and is well suited to investigate different phases of reward processing within the caudate and nucleus accumbens. To test for correlations with prediction error signals a Rescorla-Wagner reinforcement-learning model was applied. Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo. In contrast, lithium administration reduced caudate and nucleus accumbens activity during reward outcome. This latter effect seems related to learning as reward prediction errors showed a positive correlation with caudate and nucleus accumbens activity during placebo, which was absent after lithium administration. Lithium differentially modulates the anticipation relative to the learning of rewards. This suggests that lithium might reverse dampened reward anticipation while reducing overactive reward updating in patients with bipolar disorder. This specific effect of lithium suggests that a targeted modulation of reward learning may be a viable approach for novel interventions in bipolar disorder.",2020,Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo.,"['patients with bipolar disorder', 'healthy volunteers', 'Thirty-seven healthy human participants (18 males, 33 with suitable fMRI data) received 11 (±1) days of']","['lithium', 'placebo', 'lithium carbonate or placebo intervention', 'Lithium']",['caudate and nucleus accumbens activity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",37.0,0.255793,Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo.,"[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Volman', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK. volman.inge@gmail.com.'}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Pringle', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Verhagen', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging Neuroimaging (WIN), Centre for Functional MRI of the Brain (FMRIB), Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Phil J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00895-2']
2285,33128496,"Administration of skin care regimens containing β-glucan for skin recovery after fractional laser therapy: A split-face, double-blinded, vehicle-controlled study.","BACKGROUND


Laser therapies have brought dawn to refractory skin diseases, but also were accompanied by postlaser inflammation and skin barrier dysfunction. To recover skin function quickly, the research and development of active ingredients including β-glucan for postlaser repair have attracted much attention.
AIMS


To evaluate the efficacy and tolerance of skin care regimens containing β-glucan (Dermdoc®;Songyang Biotech) in repairing postlaser inflammation and skin barrier dysfunction after fractional laser therapy.
METHODS


A total of 20 patients with facial atrophic acne scars who accepted fractional laser therapy were recruited: 10 patients treated with ablative fractional CO2 laser and 10 patients treated with 1565nm nonablative fractional laser. Using the method of split-face vehicle-control study, the left half of the face was served as the treatment side and accepted skin care regimens, and the right half was control side accepted vehicle. Noninvasive bioinstrumentation of skin hydration index, transepidermal water loss (TEWL), and hemoglobin index (E value) was detected in the study. Standard digital photographs were taken at each visit. The skin tolerance and adverse effect were also evaluated by subject questionnaire.
RESULTS


Compared with the control side, the Hemoglobin index (E value) of the treatment side was improved more significantly on the 7th day (P < .05). The skin hydration index of the treatment side was better than that of the control side on the 7th and 14th day (P < .05). After treatment, the TEWL of the treatment side on the 7th day was statistically significantly lower than that of the control side (P < .05). In the subject self-assessment questionnaires, 63.2% thought the repair effect of β-glucan regimens was better than that of vehicle. The skin care regimens were well tolerated without obvious side reactions.
CONCLUSION


The skin care regimens containing β-glucan may play a positive role in accelerating the recovery of skin inflammation and barrier function after fractional laser therapy.",2020,The skin hydration index of the treatment side was better than that of the control side on the 7th and 14th day (P < .05). ,['20 patients with facial atrophic acne scars who accepted'],"['ablative fractional CO2 laser and 10 patients treated with 1565nm nonablative fractional laser', 'skin care regimens containing β-glucan (Dermdoc®;Songyang Biotech', 'skin care regimens containing β-glucan', 'fractional laser therapy']","['Noninvasive bioinstrumentation of skin hydration index, transepidermal water loss (TEWL), and hemoglobin index (E value', 'skin recovery', 'skin inflammation and barrier function', 'Hemoglobin index (E value', 'skin tolerance and adverse effect', 'skin hydration index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",20.0,0.0155879,The skin hydration index of the treatment side was better than that of the control side on the 7th and 14th day (P < .05). ,"[{'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13798']
2286,33128502,Impacts of an egg complementary feeding trial on energy intake and dietary diversity in Malawi.,"Complementary feeding diets in low- and middle-income countries are generally inadequate to meet requirements for growth and development. Food-based interventions may prevent nutrient inadequacies provided that they do not displace other nutrient-rich foods. We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were provided an egg a day for 6 months or assigned to a control group. Dietary intake of complementary foods and drinks was assessed at baseline, 3-month midline and 6-month endline visits using a tablet-based multipass 24-h recall. Up to two repeat recalls were collected at each time point in a subsample of 100 children per treatment group. At midline and endline, usual energy intake from eggs was about 30 kcal/day higher in the egg group compared with controls (p < 0.0001). Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline. There was a comparable, but nonsignificant, greater total usual energy intake from complementary foods of 30 kcal/day at midline (p = 0.128) and 36 kcal/day at endline (p = 0.087). There also was a displacement of 7 kcal/day in legumes and nuts in children at endline (p = 0.059). At midline and endline, more than 80% of children in the egg group consumed a minimally diverse diet compared with 53% at midline and 60% at endline in the control group. This study illustrates that mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other complementary foods.",2020,"Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline.","['660 children aged 6 to 9 months', 'mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other complementary foods', 'Malawi']",[],"['total usual energy intake', 'energy intake and dietary diversity']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",660.0,0.0976939,"Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline.","[{'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington, DC, School of Public Health, University of Maryland, College Park, Maryland, USA.'}, {'ForeName': 'Bess L', 'Initials': 'BL', 'LastName': 'Caswell', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Chipatala', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.13055']
2287,28700515,"Mechanical, Metabolic, and Perceptual Acute Responses to Different Set Configurations in Full Squat.","González-Hernández, JM, García-Ramos, A, Castaño-Zambudio, A, Capelo-Ramírez, F, Marquez, G, Boullosa, D, and Jiménez-Reyes, P. Mechanical, metabolic, and perceptual acute responses to different set configurations in full squat. J Strength Cond Res 34(6): 1581-1590, 2020-This study aimed to compare mechanical, metabolic, and perceptual responses between 2 traditional (TR) and 4 cluster (CL) set configurations. In a counterbalanced randomized order, 11 men were tested with the following protocols in separate sessions (sets × repetitions [interrepetition rest]): TR1: 3 × 10 [0 seconds]; TR2: 6 × 5 [0 seconds]; CL1: 3 × 10 [10 seconds]; CL2: 3 × 10 [15 seconds]; CL3: 3 × 10 [30 seconds]; CL4: 1 × 30 [15 seconds]. The exercise (full squat), number of repetitions (30), interset rest (5 minutes), and resistance applied (10 repetition maximum) was the same for all set configurations. Mechanical fatigue was quantified by measuring the mean propulsive velocity during each repetition and the change in countermovement jump height observed after each set and after the whole training session. Metabolic and perceptual fatigue were assessed via the blood lactate concentration and the OMNI perceived exertion scale measured after each training set, respectively. The mechanical, metabolic, and perceptual measures of fatigue were always significantly higher for the TR1 set configuration. The 2 set configurations that most minimized the mechanical measures of fatigue were CL2 and CL3. Perceived fatigue did not differ between the TR2, CL1, CL2, and CL3 set configurations. The lowest lactate concentration was observed in the CL3 set configuration. Therefore, both the CL2 and CL3 set configurations can be recommended because they maximize mechanical performance. However, the CL2 set configuration presents 2 main advantages with respect to CL3 (a): it reduces training session duration, and (b) it promotes higher metabolic stress, which, to some extent, may be beneficial for inducing muscle strength and hypertrophy gains.",2020,"Metabolic and perceptual fatigue were assessed via the blood lactate concentration and the OMNI perceived exertion scale measured after each training set, respectively.","['J Strength Cond Res 34(6', '11 men were tested with the following protocols in separate sessions (sets × repetitions [interrepetition rest']",['TR1'],"['blood lactate concentration and the OMNI perceived exertion scale', 'exercise (full squat), number of repetitions (30), interset rest (5 minutes), and resistance applied (10 repetition maximum', 'Mechanical fatigue', 'Perceived fatigue', 'Mechanical, Metabolic, and Perceptual Acute Responses', 'lowest lactate concentration', 'mechanical, metabolic, and perceptual responses', 'mechanical, metabolic, and perceptual measures of fatigue', 'Metabolic and perceptual fatigue']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",11.0,0.0341692,"Metabolic and perceptual fatigue were assessed via the blood lactate concentration and the OMNI perceived exertion scale measured after each training set, respectively.","[{'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Castaño-Zambudio', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Capelo-Ramírez', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Marquez', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Boullosa', 'Affiliation': 'Post-Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil and.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002117']
2288,30409822,Predictors of 1-year compliance with adaptive servoventilation in patients with heart failure and sleep disordered breathing: preliminary data from the ADVENT-HF trial.,,2019,,['patients with\xa0heart failure and sleep disordered breathing'],['adaptive servoventilation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",[],[],,0.0200167,,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Perger', 'Affiliation': 'Sleep Research Laboratory of the University Health Network Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': 'Owen D', 'Initials': 'OD', 'LastName': 'Lyons', 'Affiliation': 'Sleep Research Laboratory of the University Health Network Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Inami', 'Affiliation': 'Sleep Research Laboratory of the University Health Network Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Sleep Research Laboratory of the University Health Network Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'The University Health Network and Sinai Health System Dept of Medicine, Toronto, ON, Canada.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Logan', 'Affiliation': 'The University Health Network and Sinai Health System Dept of Medicine, Toronto, ON, Canada.'}, {'ForeName': 'T Douglas', 'Initials': 'TD', 'LastName': 'Bradley', 'Affiliation': 'Sleep Research Laboratory of the University Health Network Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01626-2018']
2289,30794101,"Association of Very Early Serum Levels of S100B, Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and Spectrin Breakdown Product with Outcome in ProTECT III.","Rapid risk-stratification of patients with acute traumatic brain injury (TBI) would inform management decisions and prognostication. The objective of this serum biomarker study (Biomarkers of Injury and Outcome [BIO]-Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment [ProTECT]) was to test the hypothesis that serum biomarkers of structural brain injury, measured at a single, very early time-point, add value beyond relevant clinical covariates when predicting unfavorable outcome 6 months after moderate-to-severe acute TBI. BIO-ProTECT utilized prospectively collected samples obtained from subjects with moderate-to-severe TBI enrolled in the ProTECT III clinical trial of progesterone. Serum samples were obtained within 4 h after injury. Glial fibrillary acidic protein (GFAP), S100B, αII-spectrin breakdown product of molecular weight 150 (SBDP150), and ubiquitin C-terminal hydrolase-L1 (UCH-L1) were measured. The association between log-transformed biomarker levels and poor outcome, defined by a Glasgow Outcome Scale-Extended (GOS-E) score of 1-4 at 6 months post-injury, were estimated via logistic regression. Prognostic models and a biomarker risk score were developed using bootstrapping techniques. Of 882 ProTECT III subjects, samples were available for 566. Each biomarker was associated with 6-month GOS-E ( p  < 0.001). Compared with a model containing baseline patient variables/characteristics, inclusion of S100B and GFAP significantly improved prognostic capacity ( p  ≤ 0.05 both comparisons); conversely, UCH-L1 and SBDP did not. A final predictive model incorporating baseline patient variables/characteristics and biomarker data (S100B and GFAP) had the best prognostic capability (area under the curve [AUC] = 0.85, 95% confidence interval [CI]: CI 0.81-0.89). Very early measurements of brain-specific biomarkers are independently associated with 6-month outcome after moderate-to-severe TBI and enhance outcome prediction.",2019,Very early measurements of brain-specific biomarkers are independently associated with 6-month outcome after moderate-to-severe TBI and enhance outcome prediction.,"['Of 882 ProTECT III subjects, samples were available for 566', 'patients with acute traumatic brain injury (TBI', 'subjects with moderate-to-severe TBI enrolled in the ProTECT III clinical trial of']",['progesterone'],"['prognostic capacity', 'Glial fibrillary acidic protein (GFAP), S100B, αII-spectrin breakdown product of molecular weight 150 (SBDP150), and ubiquitin C-terminal hydrolase-L1 (UCH-L1', 'biomarker risk score', 'Glasgow Outcome Scale-Extended (GOS-E) score']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0037799', 'cui_str': 'Spectrin'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0164005', 'cui_str': 'Ubiquitin thiolesterase'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.0636143,Very early measurements of brain-specific biomarkers are independently associated with 6-month outcome after moderate-to-severe TBI and enhance outcome prediction.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frankel', 'Affiliation': 'Department of Neurology, Emory University School of Medicine and Grady Hospital, Atlanta, Georgia.'}, {'ForeName': 'Liqiong', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Novartis Institutes of Biomedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jeromin', 'Affiliation': 'Quanterix Corp., Lexington, Massachusetts.'}, {'ForeName': 'Pieter E', 'Initials': 'PE', 'LastName': 'Vos', 'Affiliation': 'Department of Neurology, Slingeland Hospital Doetinchem, The Netherlands.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and Neuroscience, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pauls', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lunney', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Merck', 'Affiliation': 'Division of Emergency Neurosciences and Critical Care Research, The Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Emory University School of Medicine and Grady Hospital, Atlanta, Georgia.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Department of Emergency Medicine, Emory University School of Medicine and Grady Hospital, Atlanta, Georgia.'}]",Journal of neurotrauma,['10.1089/neu.2018.5809']
2290,33128325,Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure.,"BACKGROUND


TRAPS was a prospective randomized open-label non-inferiority study conducted in 14 centres in Italy. Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome.
OBJECTIVE


Aim of this paper is to report the events during the two years follow up after the study closure.
METHODS


On January 28, 2018 the trial was prematurely stopped by adjudication and safety committee for an excess of events in the rivaroxaban group. Randomized patients were advised on trial results and those randomized to rivaroxaban were solicited to switch to warfarin. All the 14 participating centres were asked and accepted to follow up their patients for clinical events. This report describes the rate of events that occurred between January 28, 2018 and January 28, 2020.
RESULTS


Of 120 randomized patients, 115 were available for follow up. Outcome events were 2 in 6 (33.3%) patients who remained on DOACs and 6 in 109 (5.7%) patients on warfarin (HR 6.9; 95%CI 1.4-34.5, p=0.018). The 2 patients on DOACs (one taking dabigatran and one taking rivaroxaban) suffered from thromboembolic events while of the 6 patients with composite outcomes on warfarin, 3 had thromboembolic events (HR for thrombosis 13.3; 95CI 2.2-79.9, p=0.005).
CONCLUSION


These data further support the use of warfarin in high-risk patients with APS.",2020,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome.
","['120 randomized patients', '14 centres in Italy', 'AntiPhospholipid Syndrome (TRAPS', 'high-risk patients with APS']","['rivaroxaban', 'Rivaroxaban', 'warfarin']","['thromboembolic events, major bleeding, and vascular death', 'thromboembolic events']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid syndrome'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.0654754,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome.
","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Pengo', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Hoxha', 'Affiliation': 'Internal Medicine, San Bortolo Hospital, Vicenza.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andreoli', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Tincani', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silvestri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Prisco', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Fierro', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gresele', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cafolla', 'Affiliation': 'Department of Translational and Precision Medicine and Hematology, Sapienza University of Rome, Rome.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'De Micheli', 'Affiliation': 'Transfusion Medicine, District Hospital, Merate.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghirarduzzi', 'Affiliation': 'Angiology Unit, Department of Internal Medicine, Santa Maria Nuova Hospital, Reggio Emilia.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Hematology Department, San Bortolo Hospital, Vicenza.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Falanga', 'Affiliation': 'Department of Immunohematology and Transfusion Medicine and Hemostasis and Thrombosis Center, Hospital Papa Giovanni XXIII, Bergamo.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Testa', 'Affiliation': 'Hemostasis and Thrombosis Center, Laboratory Medicine Department, Azienda Socio-Sanitaria Territoriale, Cremona.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Barcellona', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gerosa', 'Affiliation': 'Clincal\xa0Rheumatology Unit,\xa0Research Center for Adult and Pediatric Diseases,\xa0Department of Clinical Sciences and Community Health, ASST Pini-CTO, University of Milan, Milan, Italy.'}, {'ForeName': 'Gentian', 'Initials': 'G', 'LastName': 'Denas', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15158']
2291,33128347,"Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.","OBJECTIVE


This study aimed to evaluate the safety of avacopan, an orally administered C5a receptor inhibitor, for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis in addition to standard-of-care (SOC) treatment with glucocorticoids with cyclophosphamide or rituximab.
METHODS


In this randomized 12-week study, twice daily avacopan (10 mg or 30 mg) plus SOC was assessed versus SOC only in patients with newly diagnosed/relapsing ANCA-associated vasculitis. Efficacy measurements included 50% or greater reduction in Birmingham Vasculitis Activity Score (BVAS) at day 85, rapid reduction (day 29) of BVAS to a score of 0 that was sustained through day 85, change in Vasculitis Damage Index (VDI), renal response (improvement in estimated glomerular filtration rate [eGFR], hematuria, and albuminuria), and health-related quality of life (HRQoL).
RESULTS


Forty-two patients were randomized (n = 13 SOC, n = 13 avacopan 10 mg, and n = 16 avacopan 30 mg). Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively. In the intent-to-treat population, BVAS response was high across arms (11 of 13 SOC, 11 of 12 avacopan 10 mg, and 12 of 15 avacopan 30 mg); increases in mean VDI were greater with SOC only than with avacopan plus SOC (0.3 versus 0.1). Avacopan 30 mg was numerically superior to placebo and avacopan 10 mg in early remission (15%, 8%, and 20% for SOC only, avacopan 10 mg, and avacopan 30 mg, respectively), improved eGFR (+2.0 ml/min/1.73m 2  , +1.3 ml/min/1.73m 2  , and +6.2 ml/min/1.73m 2  , respectively), renal response (17%, 40%, and 63%, respectively), and measures of HRQoL.
CONCLUSION


Avacopan in addition to SOC for ANCA-associated vasculitis was well tolerated, and at the higher study dose, it appeared to improve time to remission (ClinicalTrials.gov identifier NCT02222155).",2020,"Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively.","['patients with newly diagnosed/relapsing ANCA-associated vasculitis', 'Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis']","['glucocorticoids with cyclophosphamide or rituximab', 'C5a receptor inhibitor', 'Avacopan, an Oral C5a Receptor Inhibitor', 'avacopan', 'Avacopan', 'placebo and avacopan', 'avacopan plus SOC']","['renal response', 'BVAS response', 'Serious adverse events', 'eGFR', 'time to remission', 'mean VDI', 'Birmingham Vasculitis Activity Score (BVAS', 'vasculitis', 'Vasculitis Damage Index (VDI), renal response (improvement in estimated glomerular filtration rate [eGFR], hematuria, and albuminuria), and health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0103647', 'cui_str': 'Anti neutrophilic cytoplasm antibody'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056196', 'cui_str': 'Lymphocyte antigen CD88'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4507514', 'cui_str': 'avacopan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",42.0,0.0814434,"Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Niles', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, New York, United States.'}, {'ForeName': 'Brad H', 'Initials': 'BH', 'LastName': 'Rovin', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bomback', 'Affiliation': 'Columbia University, New York, New York, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Potarca', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schall', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': 'Pirow', 'Initials': 'P', 'LastName': 'Bekker', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ACR open rheumatology,['10.1002/acr2.11185']
2292,33128473,Borage Oil Treated with Immobilized Lipase Inhibits Melanogenesis.,"In the present study, we demonstrated that borage (Borago officinalis L.) seed oil subjected to immobilized lipase pretreatment are enriched with linoleic acid (LNA, 18:2n-6), γ-linolenic acid (GLA, 18:3n-6), and oleic acid (OLA, 18:1n-9). We further showed that lipase-treated borage oil (LT-BOL) regulates the activity and degradation of tyrosinase, an important enzyme implicated in the synthesis of melanin in murine melanocytes, B16F10. LT-BOL and its free fatty acid components reduced the levels of melanin and tyrosinase in melanocytes with GLA exerting similar or stronger effects compared with LNA and OLA. The brightening efficacy of LT-BOL on melanin metabolism in humans was tested by an 8-week, double-blind, randomized clinical trial, which enrolled 21 Korean female adults (mean age 48.57 ± 3.28). Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks. The analysis of the skin brightness using Chromameter CR-400 confirmed that the brightness of the treated area was significantly increased (p < 0.01) after 4, 6, and 8 weeks. Together, our results suggest that LT-BOL may be suitable as a natural skin whitening cosmeceutical product.",2020,Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks.,['21 Korean female adults (mean age 48.57 ±\u20093.28'],"['LT-BOL', 'lipase-treated borage oil (LT-BOL']","['melanin metabolism', 'LT-BOL']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0212750', 'cui_str': 'borage oil'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0212750', 'cui_str': 'borage oil'}]",21.0,0.120856,Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks.,"[{'ForeName': 'Jin A', 'Initials': 'JA', 'LastName': 'Shin', 'Affiliation': ""Biotechnology Research Center, Ben's Lab., Co., Ltd., 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'Meixiang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Biotechnology Research Center, Ben's Lab., Co., Ltd., 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'Jong-Moon', 'Initials': 'JM', 'LastName': 'Jeong', 'Affiliation': 'Department of Bioscience, College of Engineering, The University of Suwon, 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.'}]",Lipids,['10.1002/lipd.12266']
2293,33128480,The effects of a single session cathodal transcranial pulsed current stimulation on corticospinal excitability: a randomised sham controlled double-blinded study.,"Transcranial pulsed current stimulation (tPCS) of the human motor cortex has received much attention in recent years. Although the effect of anodal tPCS with different frequencies has been investigated, the effect of cathodal tPCS (c-tPCS) has not been explored yet. Therefore, the aim of the present study was to investigate the effect of c-tPCS at 4 and 75 Hz frequencies on corticospinal excitability (CSE) and motor performance. In a randomized sham-controlled cross over design, fifteen healthy participants attended three experimental sessions and received either c-tPCS at 75 Hz, 4 Hz or sham with 1.5 mA for 15 min. Transcranial magnetic stimulation and grooved pegboard test were performed before, immediately after and 30 min after the completion of stimulation at rest. The findings indicate that c-tPCS at both 4 Hz and 75 Hz significantly increased CSE compared to sham. Both c-tPCS at 75 Hz and 4 Hz showed a significant increase in intracortical facilitation compared to sham, whereas the effect on short-interval intracortical inhibition was not significant. The c-tPCS at 4 Hz but not 75 Hz induced modulation of intracortical facilitation correlated with the CSE. Motor performance did not show any significant changes. These results suggest that, compared with sham stimulation, c-tPCS at both 4 Hz and 75 Hz induces an increase in CSE.",2020,"Both c-tPCS at 75 Hz and 4 Hz showed a significant increase in intracortical facilitation compared to sham, whereas the effect on short-interval intracortical inhibition was not significant.",['fifteen healthy participants attended three experimental sessions and received either'],"['Transcranial magnetic stimulation and grooved pegboard test', 'c-tPCS at 75 Hz, 4 Hz or sham with 1.5 mA for 15 min', 'single session cathodal transcranial pulsed current stimulation', 'c-tPCS', 'Transcranial pulsed current stimulation (tPCS']","['intracortical facilitation', 'short-interval intracortical inhibition', 'corticospinal excitability', 'CSE', 'Motor performance', 'corticospinal excitability (CSE) and motor performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",15.0,0.24309,"Both c-tPCS at 75 Hz and 4 Hz showed a significant increase in intracortical facilitation compared to sham, whereas the effect on short-interval intracortical inhibition was not significant.","[{'ForeName': 'Thusharika', 'Initials': 'T', 'LastName': 'Dissanayaka', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, School of Allied health, La Trobe University, Bundoora, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Egan', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",The European journal of neuroscience,['10.1111/ejn.14916']
2294,33128483,Unsupervised learning for magnetization transfer contrast MR fingerprinting: Application to CEST and nuclear Overhauser enhancement imaging.,"PURPOSE


To develop a fast, quantitative 3D magnetization transfer contrast (MTC) framework based on an unsupervised learning scheme, which will provide baseline reference signals for CEST and nuclear Overhauser enhancement imaging.
METHODS


Pseudo-randomized RF saturation parameters and relaxation delay times were applied in an MR fingerprinting framework to generate transient-state signal evolutions for different MTC parameters. Prospectively compressed sensing-accelerated (four-fold) MR fingerprinting images were acquired from 6 healthy volunteers at 3 T. A convolutional neural network framework in an unsupervised fashion was designed to solve an inverse problem of a two-pool MTC Bloch equation, and was compared with a conventional Bloch equation-based fitting approach. The MTC images synthesized by the convolutional neural network architecture were used for amide proton transfer and nuclear Overhauser enhancement imaging as a reference baseline image.
RESULTS


The fully unsupervised learning scheme incorporated with the two-pool exchange model learned a set of unique features that can describe the MTC-MR fingerprinting input, and allowed only small amounts of unlabeled data for training. The MTC parameter values estimated by the unsupervised learning method were in excellent agreement with values estimated by the conventional Bloch fitting approach, but dramatically reduced computation time by ~1000-fold.
CONCLUSION


Given the considerable time efficiency compared to conventional Bloch fitting, unsupervised learning-based MTC-MR fingerprinting could be a powerful tool for quantitative MTC and CEST/nuclear Overhauser enhancement imaging.",2020,"The MTC parameter values estimated by the unsupervised learning method were in excellent agreement with values estimated by the conventional Bloch fitting approach, but dramatically reduced computation time by ~1000-fold.
",[],[],['computation time'],[],[],"[{'cui': 'C0040223', 'cui_str': 'Time'}]",6.0,0.0245027,"The MTC parameter values estimated by the unsupervised learning method were in excellent agreement with values estimated by the conventional Bloch fitting approach, but dramatically reduced computation time by ~1000-fold.
","[{'ForeName': 'Beomgu', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': 'Department of Electrical Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Byungjai', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Electrical Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schär', 'Affiliation': 'Divison of MR Research, Department of Radiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'HyunWook', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Electrical Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Hye-Young', 'Initials': 'HY', 'LastName': 'Heo', 'Affiliation': 'Divison of MR Research, Department of Radiology, Johns Hopkins University, Baltimore, Maryland, USA.'}]",Magnetic resonance in medicine,['10.1002/mrm.28573']
2295,33128492,Topical β-blockers for pyogenic granulomas: A promising option for younger patients.,"BACKGROUND


Topical β-blockers, propranolol, and timolol were used for pyogenic granuloma (PG) treatment; however, their efficacies and safety profiles were not compared.
AIMS


The aim was to evaluate the safety and efficacy of propranolol 1% and timolol 0.5% creams in the treatment of pyogenic granulomas.
PATIENTS


The study included 30 PG patients. They were divided into three groups (10 patients each). Group I patients received propranolol 1% cream. Group II patients used timolol 0.5% l cream. Group III patients used placebo cream. Creams were applied twice daily for 2 months. Patients were followed up for 3 months to detect any recurrence.
RESULTS


Complete resolution was reported in 6 patients of groups I and II, while none of the control patients reported complete resolution. Despite the absent change in lesions' size in 40% of β-blockers treated groups, they all reported decreased bleeding tendency. There was insignificant difference between the clinical responses between β-blockers groups. No recurrence was reported in any of the patients who achieved complete resolution after 3 months of follow-up. Younger patients respond better to β-blockers. Three patients were deteriorated on beta-blockers treatment.
CONCLUSION


β-blockers are a promising PG treatment option in cases where invasive modalities are not desirable especially in younger patients.",2020,"RESULTS


Complete resolution was reported in 6 patients of groups I and II, while none of the control patients reported complete resolution.","['pyogenic granulomas', '30 PG patients', 'younger patients', 'Younger patients']","['propranolol 1% cream', 'timolol 0.5% l cream', 'Topical β-blockers', 'timolol', 'propranolol', 'propranolol, and timolol', 'placebo cream']","['bleeding tendency', 'safety and efficacy', 'complete resolution']","[{'cui': 'C0085653', 'cui_str': 'Pyogenic granuloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",3.0,0.0213563,"RESULTS


Complete resolution was reported in 6 patients of groups I and II, while none of the control patients reported complete resolution.","[{'ForeName': 'Abd El-Aziz Ibrahim', 'Initials': 'AEI', 'LastName': 'El-Taweel', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Abdul-Aziz Abdul-Salam Ahmed', 'Initials': 'AAA', 'LastName': 'Al-Refaie', 'Affiliation': 'Faculty of Medicine, Beni-swif University, Beni-swif, Egypt.'}, {'ForeName': 'Khalid Hamdy Awad', 'Initials': 'KHA', 'LastName': 'Salem', 'Affiliation': 'Ministry of Health, Cairo, Egypt.'}, {'ForeName': 'Rehab Mohammed', 'Initials': 'RM', 'LastName': 'Salem', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13800']
2296,33128533,Comparative Effect of Graded Motor Imagery and Progressive Muscle Relaxation on Mobility and Function in Patients with Knee Osteoarthritis: A Pilot Study.,"Background


Osteoarthritis (OA) is the most common musculoskeletal condition seen in aging. Joint destruction, chronic pain, change in proprioception, stability problems and decreased range of motion are the most common problems seen in OA. Complementary therapies like yoga, graded motor imagery (GMI), progressive muscle relaxation (PMR) and Tai Chi are more effective in chronic conditions such as knee OA.
Aims


The purpose of this study was to evaluate and compare the effect of graded motor imagery and progressive muscle relaxation on mobility and function in patients with knee OA.
Methods


This study was a randomized controlled pilot trial conducted in a tertiary health center in Belagavi, Karnataka, India.
Participants


A total of 11 patients with unilateral knee pain persisting for more than 12 months were included in the study.
Interventions


Patients were randomly assigned to 2 groups: the PMR group (n = 5) or the (GMI) group (n = 6). Patients in the PMR group practiced Jacobson's PMR and patients in the GMI group practiced explicit and mirror therapy. All patients were treated 5 times a week for 2 weeks.
Outcome measures


The outcome measures in this study were range of motion and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score for assessing knee joint pain, function and stiffness.
Results


Results demonstrated knee flexion range (P = .046) and function WOMAC scores (P = .0062) were significantly better in the GMI group than in the PMR group.
Conclusion


GMI and PMR were both beneficial for knee mobility and function but GMI was better than PMR in chronic knee OA.",2020,"Results


Results demonstrated knee flexion range (P = .046) and function WOMAC scores (P = .0062) were significantly better in the GMI group than in the PMR group.
","['Patients with Knee Osteoarthritis', 'Participants\n\n\nA total of 11 patients with unilateral knee pain persisting for more than 12 months were included in the study', 'tertiary health center in Belagavi, Karnataka, India', 'patients with knee OA']","['Complementary therapies like yoga, graded motor imagery (GMI), progressive muscle relaxation (PMR) and Tai Chi', 'Graded Motor Imagery and Progressive Muscle Relaxation', 'PMR', 'graded motor imagery and progressive muscle relaxation']","['range of motion and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score for assessing knee joint pain, function and stiffness', 'Joint destruction, chronic pain, change in proprioception, stability problems', 'mobility and function', 'Mobility and Function', 'function WOMAC scores', 'knee flexion range']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0936077', 'cui_str': 'Complementary therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0541875', 'cui_str': 'Joint destruction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",11.0,0.0300959,"Results


Results demonstrated knee flexion range (P = .046) and function WOMAC scores (P = .0062) were significantly better in the GMI group than in the PMR group.
","[{'ForeName': 'Peeyoosha', 'Initials': 'P', 'LastName': 'Gurudut', 'Affiliation': ''}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Jaiswal', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2297,33128534,Effects of Reiki Session Excluding the Variables Responsible for the Placebo Effect on a Group of Adults.,"Background


Reiki is a very popular method of natural healing used for prevention but also for the complementary session of many human disorders and diseases, including depression, anxiety, and various kind of chronic conditions, but also for the relief of pain and to promote relaxation and general well-being.
Primary Study Objective


The scope of this study has been to evaluate the effect of Reiki in subjects who have never received before a Reiki session and that did not know its effects or its methodological practices excluding the variables responsible for the placebo effect.
Methods/Design


A heterogeneous group of 70 volunteers, both men and women, was chosen for this study, and the results reported in this paper were obtained by analyzing the responses to questionnaires using a Likert scale.
Results


From this study demonstrated that a Reiki style of energy practice is capable of bringing people to relax in the presence of environmental disturbances and in the absence of other adjuvant techniques, such as aromatherapy, music-therapy, and preliminary relaxation, responsible for the placebo effect. The most significant effects and sensations detected from questionnaires are a perception of heat during the session, an increase in relaxation, an improvement in mood, a sense of relief, and in general an increase of well-being.
Conclusion


These findings are significant also because are related to the Reiki technique alone. However, further studies are needed to better understand its mechanisms of action and assessing its effects both on the physical body and on the emotional and psycho-spiritual part of the individual.",2020,"The most significant effects and sensations detected from questionnaires are a perception of heat during the session, an increase in relaxation, an improvement in mood, a sense of relief, and in general an increase of well-being.
","['subjects who have never received before a', 'a Group of Adults', '70 volunteers, both men and women']","['Reiki session', 'Reiki Session']",[],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}]",[],70.0,0.0400107,"The most significant effects and sensations detected from questionnaires are a perception of heat during the session, an increase in relaxation, an improvement in mood, a sense of relief, and in general an increase of well-being.
","[{'ForeName': 'Scarascia', 'Initials': 'S', 'LastName': 'Graziano', 'Affiliation': ''}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Luigi', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2298,33128535,Effects of Lung Rehabilitation Therapy in Improving Respiratory Motor Ability and Alleviating Dyspnea in Patients with Lung Cancer After Lobectomy: A Clinical Study.,"Purpose


The primacy aim of our study was to identify the effect of lung rehabilitation therapy on improving respiratory motor ability and alleviating dyspnea in patients with lung cancer after lobectomy.
Methods


The prospective study included a total of 58 patients with lung cancer who underwent lobectomy in our hospital from February 2017 to 2018. The patients were randomly divided into observation group (n = 29) and control group (n = 29). Patients in the control group were treated with routine nursing after operation, and patients in the observation group received lung rehabilitation therapy in combination with routine nursing. The pulmonary function, respiratory function and exercise ability of the patients in the two groups were compared, and fasting venous blood was taken before and after the beginning of the study. Moreover, the related serum factors were detected by enzyme-linked immunosorbent assay (Elisa).
Results


After treatment, the percentage of FEV1 and FEV1/FVC in the predicted value in the observation group was significantly different compared to that before treatment. The CAT score and exercise endurance score in the observation group showed significant difference compared to those in the control group. Compared with patients in the control group, the average hospitalization time of patients in the observation group was reduced by 2 days, and the probability of pulmonary complications decreased from 13.8% to 3.4%, with an average decrease of 10.4%. Additionally, the patients with pulmonary complications were reduced by 3 cases, and the retention time of chest tube was also remarkably reduced. CRP, IL-6 and TNF-α in serum of the observation group were significantly improved, with statistical difference.
Conclusion


Lung rehabilitation therapy is an effective approach for the recovery of motor ability and respiratory function of postoperative patients. A simple lung rehabilitation exercise training program can significantly improve the exercise tolerance of respiration for patients, alleviate dyspnea, hence improve their quality of life. In addition, routine nursing in the combination of lung rehabilitation therapy exerted greater beneficial effect in terms of reducing the inflammation and achieving improved life quality of patients.",2020,"Compared with patients in the control group, the average hospitalization time of patients in the observation group was reduced by 2 days, and the probability of pulmonary complications decreased from 13.8% to 3.4%, with an average decrease of 10.4%.","['Patients with Lung Cancer', 'patients with lung cancer after lobectomy', '58 patients with lung cancer who underwent lobectomy in our hospital from February 2017 to 2018', 'postoperative patients', 'After Lobectomy']","['Lung Rehabilitation Therapy', 'Lung rehabilitation therapy', 'lung rehabilitation therapy in combination with routine nursing', 'routine nursing', 'lung rehabilitation therapy', 'lung rehabilitation exercise training program']","['retention time of chest tube', 'Respiratory Motor Ability and Alleviating Dyspnea', 'probability of pulmonary complications', 'average hospitalization time', 'pulmonary function, respiratory function and exercise ability', 'life quality', 'respiratory motor ability and alleviating dyspnea', 'CRP, IL-6 and TNF-α in serum', 'pulmonary complications', 'CAT score and exercise endurance score', 'quality of life', 'percentage of FEV1 and FEV1/FVC', 'exercise tolerance of respiration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",58.0,0.0188404,"Compared with patients in the control group, the average hospitalization time of patients in the observation group was reduced by 2 days, and the probability of pulmonary complications decreased from 13.8% to 3.4%, with an average decrease of 10.4%.","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2299,33128538,The Effects of Mindfulness Meditation and Gentle Yoga on Spiritual Well-Being in Cancer Survivors: A Pilot Study.,"Background


Cancer survivors face countless physiological and psychological challenges that affect their abilities and negatively impact their quality of life and general well-being. A biopsychosocial-spiritual approach to health management may be beneficial.
Primary Study Objective


To assess the effect of gentle yoga and mindfulness meditation on spiritual well-being in cancer survivors.
Methods/Design


This is a mixed methods, quasi-experimental pilot study providing 10 weeks of gentle yoga and mindfulness meditation twice per week to cancer survivors.
Setting


The intervention was provided at a South Florida university in the summer months.
Participants


Ten cancer survivors self-selected to participate in the 10-week study; 2 participants did not complete the post-test data collection.
Intervention


Each class opened and closed with 5 to 6 minutes of nonmoving mindfulness meditation. The mindfulness meditation techniques included body scan, breath awareness, visualization, affirmation, and compassion meditations. The gentle yoga practice was a series of beginner yoga postures and stretches. The mindfulness meditation techniques of breath and body awareness during yoga created what is referred to as a ""moving meditation"" with yoga postures encompassing the movement portion.
Primary Outcome Measures


The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) and 2 open-ended questions.
Results


The FACIT-Sp-12 pre- and post-test data were analyzed using a paired samples t test. There was a significant improvement in overall spiritual well-being from pretest (μ = 34.25, SD = 7.28) to post-test (μ = 39.50, SD = 7.91); t (7) = -4.02, P = 0.003. Qualitative data: the participants reported improvements in various aspects of spirituality, fitness, emotional well-being, stress management, sleep, and a sense of social connectedness.
Conclusion


The biopsychosocial-spiritual approach to health care may play a vital role in addressing the well-being of the whole person. Gentle yoga and mindfulness meditation can result in improvement in measures of spiritual well-being among cancer survivors and may be further utilized as an accessible intervention for those who are suffering throughout all segments of society.",2020,"Qualitative data: the participants reported improvements in various aspects of spirituality, fitness, emotional well-being, stress management, sleep, and a sense of social connectedness.
","['Cancer Survivors', 'Participants\n\n\nTen cancer survivors self-selected to participate in the 10-week study; 2 participants did not complete the post-test data collection', 'cancer survivors']","['Gentle yoga and mindfulness meditation', 'Mindfulness Meditation and Gentle Yoga', 'gentle yoga and mindfulness meditation']","['body scan, breath awareness, visualization, affirmation, and compassion meditations', 'spirituality, fitness, emotional well-being, stress management, sleep, and a sense of social connectedness', 'Functional Assessment of Chronic Illness Therapy - Spiritual', 'overall spiritual']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0261213,"Qualitative data: the participants reported improvements in various aspects of spirituality, fitness, emotional well-being, stress management, sleep, and a sense of social connectedness.
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': ''}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Zipp', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Breitkreuz', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2300,33128587,Autograft type affects muscle strength and hop performance after ACL reconstruction. A randomised controlled trial comparing patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation.,"PURPOSE


To evaluate and compare changes in quadriceps and hamstring strength and single-leg-hop (SLH) test performance over the first 24 postoperative months in patients who underwent anterior cruciate ligament reconstruction (ACLR) with bone-patellar tendon-bone (BPTB) or hamstring tendon (HT) autografts and followed either a standard or an accelerated rehabilitation protocol.
METHODS


A total of 160 patients undergoing ACLR were randomised in four groups depending on the graft that was used and the rehabilitation protocol (40 BPTB/standard rehab, 40 BPTB/accelerated rehab, 40 HT/standard rehab, 40 HT/accelerated rehab). Isokinetic concentric quadriceps and hamstring strength at 90°/s and the SLH test performance were assessed preoperatively and 4,6,8,12 and 24 months postoperatively. The results were reported as the limb symmetry index (LSI) at the same time point. Linear mixed models were used to compare the groups at the different time points.
RESULTS


An average quadriceps strength LSI of 78.4% was found preoperatively. After ACLR, the LSI first decreased at 4 months and then increased from 6 to 24 months, reaching an overall value of 92.7% at the latest follow-up. The BPTB group showed a significantly decreased LSI at 4, 6, 8 and 12 months compared with the HT group. No significant differences between the graft groups were found at 24 months. An average hamstring strength LSI of 84.6% was found preoperatively. After ACLR, the LSI increased from 4 to 24 months in the BTPB group. In the HT group, the LSI first decreased at 4 months and then increased from 6 to 24 months. An LSI of 97.1% and 89.1% was found at the latest follow-up for the BPTB and the HT group, respectively. The HT group showed a significantly decreased LSI at all follow-ups compared with the BPTB group. An average SLH test LSI of 81% was found preoperatively. After ACLR, the LSI increased from 4 to 24 months, reaching 97.6% overall at the latest follow-up. The BPTB group showed a significantly decreased LSI only at 4 months postoperatively compared with the HT group. No significant differences in any of the three tests were found between the standard and accelerated rehabilitation groups for either of the graft groups at any time point.
CONCLUSION


Muscle strength and SLH test performance recovered progressively after ACLR overall, but they did not all fully recover, as the injured leg performed on average less than 100% compared with the uninjured leg even 24 months postoperatively. After ACLR, inferior quadriceps strength and a poorer SLH test performance were found at 4, 6, 8 and 12 months and at 4 months, respectively, for the BTPB group compared with the HT group. Persistent, inferior hamstring strength was found at all postoperative follow-ups in the HT group. Rehabilitation, standard or accelerated, had no significant impact on the recovery of muscle strength and SLH test performance after ACLR in any of the graft groups.
LEVEL OF EVIDENCE


Level I.",2020,"No significant differences in any of the three tests were found between the standard and accelerated rehabilitation groups for either of the graft groups at any time point.
","['patients who underwent', '160 patients undergoing ACLR']","['rehabilitation protocol (40 BPTB/standard rehab, 40 BPTB/accelerated rehab, 40 HT/standard rehab, 40 HT/accelerated rehab', 'anterior cruciate ligament reconstruction (ACLR) with bone-patellar tendon-bone (BPTB) or hamstring tendon (HT) autografts and followed either a standard or an accelerated rehabilitation protocol', 'patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation']","['Isokinetic concentric quadriceps and hamstring strength', 'average hamstring strength LSI', 'inferior quadriceps strength and a poorer SLH test performance', 'recovery of muscle strength and SLH test performance', 'quadriceps and hamstring strength and single-leg-hop (SLH) test performance', 'inferior hamstring strength', 'limb symmetry index (LSI', 'SLH test performance', 'LSI first', 'average quadriceps strength LSI', 'LSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",160.0,0.0197058,"No significant differences in any of the three tests were found between the standard and accelerated rehabilitation groups for either of the graft groups at any time point.
","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cristiani', 'Affiliation': 'Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center, Karolinska Institutet, Stockholm, Sweden. riccardo.cristiani87@gmail.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wange', 'Affiliation': 'Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olsson', 'Affiliation': 'Unit of Medical Statistics, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Stålman', 'Affiliation': 'Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Engström', 'Affiliation': 'Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06334-5']
2301,33128801,"Dexmedetomidine versus Clonidine Adjuvants to Levobupivacaine for Ultrasound-Guided Transversus Abdominis Plane Block in Pediatric Laparoscopic Orchiopexy: Randomized, Double-Blind Study.","BACKGROUND


Laparoscopic surgeries are associated with less postoperative pain and adverse events compared to open procedures. But, it still reduces quality of life in children. Transversus abdominis plane (TAP) block is used to reduce pain. We hypothesized that dexmedetomidine or clonidine could improve the analgesic profile of levobupivacaine to the same extent during TAP block in children.
METHODS


Ninety children were randomly allocated in a randomized double-blind trial to receive bilateral TAP block with levobupivacaine plus normal saline (Group-B, n=30), or dexmedetomidine (Group-D, n=30), or clonidine (Group-C, n=30). Primary outcome was the modified CHEOPS score. Secondary outcomes included time to initial analgesic request, number of analgesic claims, total analgesic consumption, parents' satisfaction, sedation score, and complications.
RESULTS


Children of group-D showed reduced pain scores compared to other groups. They represented the longest period of analgesia (565.00 ± 71.5 minutes) with p-value < 0.001, and fewer patients required two doses of analgesia during the first postoperative day. The cumulative amount of backup analgesia was significantly different between these groups (p-value = 0.026). Higher parents' satisfaction scores were recorded in groups D and C compared to group-B. Sedation among the study groups revealed significant differences (p-value = 0.035), but no severe complications were recorded.
CONCLUSIONS


Adding dexmedetomidine to levobupivacaine can extend the time of analgesia, reduce the use of postoperative backup analgesics with minimal sedation effects when used in TAP block in pediatrics undergoing laparoscopic orchiopexy. Clonidine can be used as an alternative adjuvant to local anesthetics with good postoperative analgesic profiles.",2020,"Higher parents' satisfaction scores were recorded in groups D and C compared to group-B. Sedation among the study groups revealed significant differences (p-value = 0.035), but no severe complications were recorded.
","['Pediatric Laparoscopic Orchiopexy', 'Ninety children', 'children', 'pediatrics undergoing laparoscopic orchiopexy']","['Levobupivacaine', 'Clonidine', 'bilateral TAP block with levobupivacaine plus normal saline', 'Dexmedetomidine', 'levobupivacaine', 'dexmedetomidine', 'Transversus abdominis plane (TAP) block', 'clonidine']","['modified CHEOPS score', 'analgesic profile', 'cumulative amount of backup analgesia', 'postoperative pain and adverse events', ""Higher parents' satisfaction scores"", 'reduced pain scores', 'severe complications', ""time to initial analgesic request, number of analgesic claims, total analgesic consumption, parents' satisfaction, sedation score, and complications"", 'quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2717780', 'cui_str': 'Laparoscopic Orchiopexy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.498786,"Higher parents' satisfaction scores were recorded in groups D and C compared to group-B. Sedation among the study groups revealed significant differences (p-value = 0.035), but no severe complications were recorded.
","[{'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Egypt.'}, {'ForeName': 'Esam', 'Initials': 'E', 'LastName': 'Hamed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1689']
2302,33128847,"Pharmacokinetics, Bioequivalence, and Safety Studies of Pantoprazole Sodium Enteric-Coated Tablets in Healthy Subjects.","This study aimed to evaluate the bioequivalence of 2 pantoprazole sodium enteric-coated tablet formulations, a generic formulation and a branded formulation, and to investigate their pharmacokinetic and safety profiles. The study was designed as a single-center, randomized, open-label, single-dose, dual-period, and 2-sequence crossover trial, and was divided into fasting and postprandial human bioequivalence trials. In the first trial, 36 subjects were fasted overnight before they were given generic or branded tablets (during 2 separate administration periods). Separately, 42 subjects were provided a high-fat meal 1 hour before the drugs were administered. Blood specimens of each subject were obtained up to 24 hours after drug administration. No significant differences were observed between the pharmacokinetic profiles of the generic and branded pantoprazole sodium enteric-coated tablets. Bioequivalence was evaluated using 90% confidence intervals for the ratio of test/reference log area under the concentration-time curve over 24 hours, log area under the concentration-time curve to infinity (AUC 0-∞  ), and log peak concentration (C max  ). The 90% confidence intervals of the least squares geometric mean ratio of C max  , area under the concentration-time curve from time zero to the last measurable concentration (AUC 0-t  ), and AUC 0-∞  of 36 subjects in the fasting trial and of 40 of 41 subjects in the postprandial trial (C max  [41], AUC 0-t  [41], and AUC 0-∞  [40]) were in accordance with the bioequivalence criteria. No severe adverse effects were detected. The generic and branded pantoprazole sodium enteric-coated tablets were considered bioequivalent with similar safety profiles.",2020,No significant differences were observed between the pharmacokinetic profiles of the generic and branded pantoprazole sodium enteric-coated tablets.,"['36 subjects', 'Healthy Subjects']","['Pantoprazole Sodium Enteric-Coated Tablets', 'pantoprazole sodium enteric-coated tablets', 'pantoprazole sodium enteric-coated tablet formulations']","['pharmacokinetic profiles of the generic and branded pantoprazole sodium enteric-coated tablets', 'least squares geometric mean ratio of C max  , area under the concentration-time curve', 'severe adverse effects']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0795650', 'cui_str': 'Pantoprazole sodium'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0039226', 'cui_str': 'Gastro-resistant oral tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0795650', 'cui_str': 'Pantoprazole sodium'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",36.0,0.0279647,No significant differences were observed between the pharmacokinetic profiles of the generic and branded pantoprazole sodium enteric-coated tablets.,"[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Ningbo Hospital of Traditional Chinese Medicine, Zhejiang, China.'}, {'ForeName': 'Fangliang', 'Initials': 'F', 'LastName': 'Gan', 'Affiliation': 'Office of Drug Clinical Trial Institution, Xianning Central Hospital, Hubei, China.'}, {'ForeName': 'Xiali', 'Initials': 'X', 'LastName': 'Rao', 'Affiliation': 'Office of Drug Clinical Trial Institution, Xianning Central Hospital, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Office of Drug Clinical Trial Institution, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Office of Drug Clinical Trial Institution, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.888']
2303,33128903,Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study.,"BACKGROUND


Fostemsavir, a prodrug of the first-in-class attachment inhibitor, temsavir, is indicated for heavily treatment-experienced individuals with multidrug-resistant HIV-1. We previously reported superior efficacy of fostemsavir versus placebo in the randomised cohort of the BRIGHTE study after 8-day functional monotherapy (primary endpoint); here we report planned interim analyses through week 96.
METHODS


BRIGHTE (NCT02362503) is an ongoing multicentre, two-cohort, phase 3 trial, done at 108 centres in 22 countries. We enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received oral fostemsavir (600 mg twice a day) or placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy; or the non-randomised cohort, in which patients with no remaining antiretroviral options received oral fostemsavir (600 mg twice a day) plus optimised background therapy from day 1. Endpoints for the week 96 interim analyses included the proportions of participants with plasma HIV-1 RNA of less than 40 copies per mL, changes from baseline in CD4 cell counts, and the frequency of adverse events, adverse events leading to discontinuation, and deaths. The intention-to-treat exposed population and the safety population both included all participants who received at least one dose of study treatment. The response rates (proportion of participants with HIV-1 RNA <40 copies per mL) in the intention-to-treat exposed population were calculated via snapshot analysis at weeks 24, 48, and 96.
FINDINGS


Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort. 320 (86%) of 371 reported a history of AIDS. In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96. Response rates in the non-randomised cohort were 37% (37 of 99) at week 24 and week 96. Mean increases in CD4 counts from baseline at week 96 were 205 cells per μL (SD 191) in the randomised cohort and 119 cells per μL (202) in the non-randomised cohort. Mean CD4/CD8 ratio increased from 0·20 at baseline to 0·44 at week 96 in the randomised cohort. Few adverse events led to discontinuation (26 [7%] of 371). 12 (4%) of 272 people in the randomised cohort and 17 (17%) of 99 in the non-randomised cohort died; the median baseline CD4 count for participants who died was 11 cells per μL.
INTERPRETATION


In heavily treatment-experienced individuals with advanced HIV-1 disease and limited treatment options, fostemsavir-based antiretroviral regimens were generally well tolerated and showed a distinctive trend of increasing virological and immunological response rates through 96 weeks; these findings support fostemsavir as a treatment option for this vulnerable population.
FUNDING


ViiV Healthcare.",2020,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","['heavily treatment-experienced individuals', 'heavily treatment-experienced individuals with multidrug-resistant HIV-1', '108 centres in 22 countries', 'enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received', 'Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort', '320 (86%) of 371 reported a history of AIDS']","['HIV-1 attachment inhibitor prodrug fostemsavir', 'placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy', 'oral fostemsavir', 'oral fostemsavir (600 mg twice a day) plus optimised background therapy', 'fostemsavir versus placebo']","['CD4 counts', 'response rates', 'Safety and efficacy', 'Response rates', 'Mean CD4/CD8 ratio', 'median baseline CD4 count', 'proportions of participants with plasma HIV-1 RNA', 'rates of virological suppression', 'CD4 cell counts', 'frequency of adverse events, adverse events leading to discontinuation, and deaths']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C4519220', 'cui_str': 'fostemsavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",272.0,0.540505,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lataillade', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA. Electronic address: max.x.lataillade@viivhealthcare.com.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kozal', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases Section, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Department of Infectious and Tropical Diseases, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Alcalá University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'STD and AIDS Clinical Research Laboratory, Infectious Diseases, Instituto de Pesquisa Clínica Evandro Chagas FIOCRUZ, Rio De Janeiro, Brazil.'}, {'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Diaz', 'Affiliation': 'Infectious Diseases Division, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'Clinic of Infectious Diseases, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Princy N', 'Initials': 'PN', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine and Microbiology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Gulam H', 'Initials': 'GH', 'LastName': 'Latiff', 'Affiliation': 'Maxwell Centre, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'De Jesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Upper Providence Township, PA, USA.'}, {'ForeName': 'Shiven', 'Initials': 'S', 'LastName': 'Chabria', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pierce', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ackerman', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Llamoso', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30240-X']
2304,33128906,A Bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial.,"Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine. This design presents unique challenges in interpretation. First, with two active arms, HIV incidence might be low. Second, the effectiveness of tenofovir disoproxil fumarate plus emtricitabine varies across populations; thus, similar HIV incidence between groups could be consistent with a wide range of effectiveness for the new PrEP. We propose a two-part approach to trial results. First, we use Bayesian methods to incorporate assumptions about the background incidence of HIV in the trial in the absence of PrEP, possibly augmented by external data. On the basis of the estimated background incidence, we estimate and compare the number of averted (or prevented) HIV infections in each of the two trial groups, calculating the averted infections ratio. We apply these methods to a completed trial of tenofovir alafenamide plus emtricitabine for PrEP. Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.",2020,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,[],"['PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine', 'HIV pre-exposure prophylaxis (PrEP', 'tenofovir disoproxil fumarate plus emtricitabine', 'tenofovir alafenamide plus emtricitabine']",['number of averted (or prevented) HIV infections'],[],"[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]",,0.217817,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,"[{'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Electronic address: david.glidden@ucsf.edu.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Stirrup', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Dunn', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30192-2']
2305,33129157,Long-term outcomes of Prompt Mental Health Care: A randomized controlled trial.,"Prompt Mental Health Care (PMHC, Norwegian adaptation of Improving Access to Psychological Therapies) is found successful in alleviating symptoms of anxiety and depression. Here, we investigate whether improvement is maintained over time. A randomized controlled trial was conducted in two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n = 463, TAU n = 218). Main outcomes were recovery rates and changes in symptoms of depression and anxiety from baseline to 12 months. Secondary outcomes were functional status, health-related quality of life, mental wellbeing and work participation. At 12 months after baseline the reliable recovery rate was 59.4% in PMHC and 36.6% in TAU, giving a between-group effect size of 0.51 (95%CI: 0.26, 0.77, p < 0.001). Differences in symptom change gave between-group effect sizes of -0.67 (95%CI: -0.99, -0.36, p < 0.001) for depression and -0.58 (95%CI: -0.91, -0.26, p < 0.001) for anxiety. PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation. In sum, substantial treatment effects of PMHC remain at 12 months follow-up, although results should be interpreted with caution due to risk of attrition bias.",2020,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","['two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n\xa0=\xa0463, TAU n\xa0=\xa0218']","['PMHC', '95%CI', 'Prompt Mental Health Care']","['functional status, health-related quality of life, mental wellbeing and work participation', 'functional status, health-related quality of life and mental wellbeing', 'reliable recovery rate', 'anxiety', 'recovery rates and changes in symptoms of depression and anxiety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",681.0,0.216902,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","[{'ForeName': 'Solbjørg Makalani', 'Initials': 'SM', 'LastName': 'Myrtveit Sæther', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: makalani@myrtveit.com.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Knapstad', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway; Department of Clinical Psychology, University of Bergen, Bergen, Norway. Electronic address: marit.knapstad@fhi.no.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, United Kingdom; School of Psychology, University of Sussex, United Kingdom. Electronic address: n.Grey@sussex.ac.uk.'}, {'ForeName': 'Marit Aase', 'Initials': 'MA', 'LastName': 'Rognerud', 'Affiliation': 'Health Section, Oslo Municipality, Oslo, Norway. Electronic address: marogner@outlook.com.'}, {'ForeName': 'Otto R F', 'Initials': 'ORF', 'LastName': 'Smith', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: robert.smith@fhi.no.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103758']
2306,32691121,"Letter to the editor regarding ""Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study"".",,2020,,[],['bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous'],[],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],,0.0740354,,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Shigemura', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. tshigepon@yahoo.co.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}]",International orthopaedics,['10.1007/s00264-020-04744-1']
2307,33128912,"Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial.","BACKGROUND


Despite intracerebral haemorrhage causing 5% of deaths worldwide, few evidence-based therapeutic strategies other than stroke unit care exist. Tranexamic acid decreases haemorrhage in conditions such as acute trauma and menorrhoea. We aimed to assess whether tranexamic acid reduces intracerebral haemorrhage growth in patients with acute intracerebral haemorrhage.
METHODS


We did a prospective, double-blind, randomised, placebo-controlled, investigator-led, phase 2 trial at 13 stroke centres in Australia, Finland, and Taiwan. Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography. Patients were randomly assigned (1:1) to receive either 1 g of intravenous tranexamic acid over 10 min followed by 1 g over 8 h or matching placebo, started within 4·5 h of symptom onset. Randomisation was done using a centralised web-based procedure with randomly permuted blocks of varying size. All patients, investigators, and staff involved in patient management were masked to treatment. The primary outcome was intracerebral haemorrhage growth (>33% relative or >6 mL absolute) at 24 h. The primary and safety analyses were done in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT01702636).
FINDINGS


Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the tranexamic acid group (n=50) or the placebo group (n=50). Median age was 71 years (IQR 57-79) and median intracerebral haemorrhage volume was 14·6 mL (7·9-32·7) at baseline. The primary outcome was not different between the two groups: 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group had intracerebral haemorrhage growth (odds ratio [OR] 0·72 [95% CI 0·32-1·59], p=0·41). There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications. None of the deaths was considered related to study medication.
INTERPRETATION


Our study does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth, although the treatment was safe with no increase in thromboembolic complications. Larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window, are justified.
FUNDING


National Health and Medical Research Council, Royal Melbourne Hospital Foundation.",2020,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"['Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography', 'patients with acute intracerebral haemorrhage', 'Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the', '13 stroke centres in Australia, Finland, and Taiwan', 'patients with intracerebral haemorrhage (STOP-AUST']","['intravenous tranexamic acid', 'placebo', 'tranexamic acid', 'Tranexamic acid']","['median intracerebral haemorrhage volume', 'thromboembolic complications', 'intracerebral haemorrhage growth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449867', 'cui_str': 'Use of anticoagulation'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",100.0,0.776123,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"[{'ForeName': 'Atte', 'Initials': 'A', 'LastName': 'Meretoja', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Neurology, Helsinki University Hospital, Helsinki, Finland. Electronic address: atte.meretoja@hus.fi.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; New Zealand Brain Research Institute, Christchurch, New Zealand.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Mathematics and Statistics, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Gerli', 'Initials': 'G', 'LastName': 'Sibolt', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jiann-Shing', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurology, Austin Hospital, Heidelberg, VIC, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Department of Neurology, Western Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Der-Yang', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Neurosurgery, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Monash University, Melbourne, VIC, Australia; Department of Clinical Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Thanh', 'Initials': 'T', 'LastName': 'Phan', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurosciences, Eastern Health Medical School, Monash University, Melbourne, VIC, Australia; Ambulance Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moey', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Aviv', 'Affiliation': 'Department of Radiology, Neuroradiology Section, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Christen D', 'Initials': 'CD', 'LastName': 'Barras', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; South Australian Health and Medical Research Institute, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Curtze', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Strbian', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sung-Chun', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia; Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30369-0']
2308,33128939,Rare Functional Variants Associated with Antidepressant Remission in Mexican-Americans: Short title: Antidepressant remission and pharmacogenetics in Mexican-Americans.,"INTRODUCTION


Rare genetic functional variants can contribute to 30-40% of functional variability in genes relevant to drug action. Therefore, we investigated the role of rare functional variants in antidepressant response.
METHOD


Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD) participated in a prospective randomized, double-blind study with desipramine or fluoxetine. The rare variant analysis was performed using whole-exome genotyping data. Network and pathway analyses were carried out with the list of significant genes.
RESULTS


The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01). Pathway analysis of these genes supports the involvement of the following gene ontology processes: olfactory/sensory transduction, regulation of response to cytokine stimulus, and meiotic cell cycleprocess.
LIMITATIONS


Our study did not have a placebo arm. We were not able to use antidepressant blood level as a covariate. Our study is based on a small sample size of only 65 Mexican-American individuals. Further studies using larger cohorts are warranted.
CONCLUSION


Our data identified several rare functional variants in antidepressant drug response in MDD patients. These have the potential to serve as genetic markers for predicting drug response.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00265291.",2020,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","['Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD', '65 Mexican-American individuals', 'MDD patients', 'Mexican-Americans']",['desipramine or fluoxetine'],['Antidepressant remission and pharmacogenetics'],"[{'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]",,0.0426557,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","[{'ForeName': 'Ma-Li', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: wongma@upstate.edu.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arcos-Burgos', 'Affiliation': 'Grupo de Investigación en Psiquiatría, Departamento de Psiquiatría, Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellin, Antioquia, Colombia.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice W', 'Initials': 'AW', 'LastName': 'Licinio', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Eunice W M', 'Initials': 'EWM', 'LastName': 'Chin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Neuroscience & Regenerative Medicine, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Medical Clinic III, Carl Gustav Carus University Hospital, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Licinio', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: licinioJ@upstate.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.027']
2309,33129015,Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.,"OBJECTIVE


The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).
STUDY DESIGN


Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).
RESULTS


CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).
CONCLUSIONS


Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.",2020,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","['deep endometriosis', 'deep infiltrative endometriosis (DIE', 'hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up']","['electrotherapy', 'self-applied electrotherapy treatment']","['CPP relief', 'higher total score post-treatment for the EHP-30', 'quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI', 'scores for lubrication and pain domains', 'deep dyspareunia', 'chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia', 'FSFI score']","[{'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0423747', 'cui_str': 'Deep pain on intercourse'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1.0,0.0619372,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","[{'ForeName': 'Ticiana A A', 'Initials': 'TAA', 'LastName': 'Mira', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: ticiana.mira@gmail.com.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Yela', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: yeladaniela12@gmail.com.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Podgaec', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: sergiopodgaec@me.com.'}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: ecbaracat@gmail.com.'}, {'ForeName': 'Cristina L', 'Initials': 'CL', 'LastName': 'Benetti-Pinto', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: laguna.unicamp@gmail.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.018']
2310,33129099,"Nano-curcumin therapy, a promising method in modulating inflammatory cytokines in COVID-19 patients.","BACKGROUND


As an ongoing worldwide health issue, Coronavirus disease 2019 (COVID-19) has been causing serious complications, including pneumonia, acute respiratory distress syndrome (ARDS), and multi-organ failure. However, there is no decisive treatment approach available for this disorder, which is primarily attributed to the large amount of inflammatory cytokine production. We aimed to identify the effects of Nano-curcumin on the modulation of inflammatory cytokines in COVID-19 patients.
METHOD


Forty COVID-19 patients and 40 healthy controls were recruited and evaluated for inflammatory cytokine expression and secretion. Subsequently, COVID-19 patients were divided into two groups: 20 patients receiving Nano-curcumin and 20 patients as the placebo group. The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
RESULT


Our primary results indicated that the mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18 were increased significantly in COVID-19 patients compared with healthy control group. After treatment with Nano-curcumin, a significant decrease in IL-6 expression and secretion in serum and in supernatant (P = 0.0003, 0.0038, and 0.0001, respectively) and IL-1β gene expression and secretion level in serum and supernatant (P = 0.0017, 0.0082, and 0.0041, respectively) was observed. However, IL-18 mRNA expression and TNF-α concentration were not influenced by Nano-curcumin.
CONCLUSION


Nano-curcumin, as an anti-inflammatory herbal based agent, may be able to modulate the increased rate of inflammatory cytokines especially IL-1β and IL-6 mRNA expression and cytokine secretion in COVID-19 patients, which may cause an improvement in clinical manifestation and overall recovery.",2020,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","['Forty COVID-19 patients and 40 healthy controls', 'COVID-19 patients']","['placebo', 'Nano-curcumin']","['IL-6 expression and secretion in serum and in supernatant', 'mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18', 'inflammatory cytokine expression and secretion', 'IL-18 mRNA expression and TNF-α concentration', 'mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18', 'IL-1β gene expression and secretion level in serum and supernatant']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",40.0,0.0296856,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abdolmohammadi-Vahid', 'Affiliation': ""Student's Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Danshina', 'Affiliation': 'Department of propaedeutics of dental diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ziya Gencer', 'Affiliation': 'Department of Family Medicine, Yassawi International Kazakh-Turkish University Hospital, Turkistan, Kazakhstan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ammari', 'Affiliation': 'Department of Surgery, Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Roshangar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ghaebi', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ahmadi.m@tbzmed.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107088']
2311,33129156,Worry impairs the problem-solving process: Results from an experimental study.,"INTRODUCTION


Many individuals believe that worry helps solve real-life problems. Some researchers also purport that nonpathological worry can aid problem solving. However, this is in contrast to evidence that worry impairs cognitive functioning.
OBJECTIVE


This was the first study to empirically test the effects of a laboratory-based worry induction on problem-solving abilities.
PROCEDURE


Both high (n = 96) and low (n = 89) trait worriers described a current problem in their lives. They were then randomly assigned to contemplate their problem in a worrisome (n = 60) or objective (n = 63) manner or to engage in a diaphragmatic breathing task (n = 62). All participants subsequently generated solutions and then selected their most effective solution. Next, they rated their confidence in the solution's effectiveness, their likelihood to implement the solution, and their current anxiety/worry. Experimenters uninformed of condition also rated solution effectiveness.
RESULTS


The worry induction led to lower reported confidence in solutions for high trait worry participants, and lower experimenter-rated effectiveness of solutions for all participants, relative to objective thinking. Further, state worry predicted less reported intention to implement solutions, while controlling for trait worry. Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
CONCLUSIONS


Overall, the worry induction impaired problem solving on multiple levels, and this was true for both high and low trait worriers.",2020,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
",[],"['worrisome (n\xa0=\xa060) or objective (n\xa0=\xa063) manner or to engage in a diaphragmatic breathing task', 'laboratory-based worry induction']",['elevated worry and anxiety'],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",96.0,0.0612885,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Llera', 'Affiliation': 'Department of Psychology, Towson University, 8000 York Road, Towson, MD, 21252, USA. Electronic address: sllera@towson.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, 140 Moore Building, University Park, PA, 16801, USA. Electronic address: mgn1@psu.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103759']
2312,32689594,Intracranial and systemic atherosclerosis in the NAVIGATE ESUS trial: Recurrent stroke risk and response to antithrombotic therapy.,"BACKGROUND


Non-stenotic intracranial and systemic atherosclerosis are associated with ischemic stroke. We report frequency and response to anticoagulant vs. antiplatelet prophylaxis of patients with embolic stroke of undetermined source (ESUS) who have non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.
METHODS


Exploratory analysis of the international NAVIGATE ESUS randomized trial comparing rivaroxaban 15mg daily with aspirin 100mg daily in 7213 patients with recent ESUS. Among participants with results of intracranial arterial imaging with either computed tomographic angiography (CTA) or magnetic resonance angiography (MRA), the frequency and predictors of non-stenotic intracranial and systemic atherosclerosis and responses to antithrombotic therapy were assessed.
RESULTS


Among 4723 participants with available intracranial CTA or MRA results (65% of the trial cohort), the prevalence of intracranial atherosclerosis was 16% (n=739). Patient features independently associated with intracranial atherosclerosis included East Asian region (odds ratio 2.7, 95%CI 2.2,3.3) and cervical carotid plaque (odds ratio 2.3, 95%CI 1.9,2.7), among others. The rate of recurrent ischemic stroke averaged 4.8%/year among those with intracranial atherosclerosis vs. 5.0.%/year for those without (HR 0.95, 95%CI 0.65, 1.4). Among those with intracranial atherosclerosis, the recurrent ischemic stroke rate was higher if assigned to rivaroxaban (5.8%/year) vs. aspirin (3.7%/year), but the difference was not statistically significant (HR 1.6, 95%CI 0.78, 3.3). There was trend for the effect of antithrombotic treatments to be different according to the presence or absence of intracranial atherosclerosis (p interaction =0.09). Among participants with evidence of systemic atherosclerosis by either history or imaging (n=3820), recurrent ischemic stroke rates were similar among those assigned to rivaroxaban (5.5%/year) vs. aspirin (4.9%/year)(HR 1.1, 95%CI 0.84, 1.5).
CONCLUSIONS


East Asia region was the strongest factor associated with intracranial atherosclerosis. There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.",2020,There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.,"['patients with embolic stroke of undetermined source (ESUS) who have non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis', 'patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis', 'participants with evidence of systemic atherosclerosis by either history or imaging (n=3820', '7213 patients with recent ESUS', '4723 participants with available intracranial CTA or MRA results (65% of the trial cohort', 'participants with results of intracranial arterial imaging with either']","['computed tomographic angiography (CTA) or magnetic resonance angiography (MRA', 'aspirin', 'anticoagulant vs. antiplatelet prophylaxis', 'rivaroxaban', 'aspirin prophylaxis']","['recurrent ischemic stroke rates', 'prevalence of intracranial atherosclerosis', 'recurrent ischemic stroke rate', 'recurrent ischemic stroke', 'intracranial atherosclerosis included East Asian region', 'rate of recurrent ischemic stroke', 'cervical carotid plaque']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0729799', 'cui_str': 'Aspirin prophylaxis'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",7213.0,0.167373,There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.,"[{'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Ameriso', 'Affiliation': 'Institute for Neurological Research-FLENI, Buenos Aires, Argentina. Electronic address: sameriso@fleni.org.ar.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology, Bichat Hospital, Paris University, Paris, France.'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND, USA.'}, {'ForeName': 'Kanjana S', 'Initials': 'KS', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine (Neurology), McMaster University/Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': 'Medical Faculty, Hospital St. John of God, Sigmund Freud Private University, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Byung-Woo', 'Initials': 'BW', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lavados', 'Affiliation': 'Clinica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Firstenfeld', 'Affiliation': 'Instituto Cardiologico Banfield, Buenos Aires, Argentina.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Guillermo Pablo', 'Initials': 'GP', 'LastName': 'Povedano', 'Affiliation': 'Complejo Medico de la PFA Churruca Visca, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ferrari', 'Affiliation': 'Hospital Interzonal General de Agudos Eva Peron, Buenos Aires, Argentina.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ, USA.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine (Cardiology), McMaster University / Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104936']
2313,32689617,Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients.,"BACKGROUND AND PURPOSE


Stroke patients have limited ranges of motion and gait disturbances due to neurological deficits and connective tissue changes. We assessed the effects of joint mobilization and active stretching on ankle joint range of motion and gait in stroke patients.
METHODS


In total, 45 stroke patients were evenly divided into three groups: joint mobilization, active stretching, and combination (joint mobilization and active stretching) groups. Patients in each group received the corresponding interventions in a non-simultaneous manner for 6 weeks in total (3 days per week, 15 min per day). The range of motion of the ankle joint was measured using a goniometer, and spatiotemporal gait variables were measured using G-walk. All measurements were taken immediately before and after the 6-week intervention.
RESULTS


The joint mobilization group exhibited significantly increased range of motion for ankle joint after the intervention (p < 0.05), while the spatiotemporal gait variables were unchanged. In the active stretching group, both the range of motion of the ankle joint in the supine position and the spatiotemporal gait variables (cadence, speed, stride length) were significantly increased (p < 0.05). In the combination group, both the range of motion of the ankle joint and spatiotemporal gait variables (cadence, speed, stride length) were significantly increased (p < 0.05).
CONCLUSION


Combination therapy of joint mobilization and active stretching improves the range of motion of the ankle joint and spatiotemporal gait variables in stroke patients, suggesting that ankle rehabilitation of stroke patients should include limited joint structure and muscles shortness.",2020,"The joint mobilization group exhibited significantly increased range of motion for ankle joint after the intervention (p < 0.05), while the spatiotemporal gait variables were unchanged.","['Stroke patients', 'stroke patients', '45 stroke patients']","['joint mobilization, active stretching, and combination (joint mobilization and active stretching', 'joint mobilization and active stretching', 'joint mobilization and stretching', 'active stretching']","['range of motion for ankle joint', 'spatiotemporal gait variables', 'range of motion for ankle joint and spatiotemporal gait variables', 'range of motion of the ankle joint and spatiotemporal gait variables', 'spatiotemporal gait variables (cadence, speed, stride length', 'range of motion of the ankle joint', 'range of motion of the ankle joint and spatiotemporal gait variables (cadence, speed, stride length']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C1720873', 'cui_str': 'Static-Active Stretching'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",45.0,0.0296743,"The joint mobilization group exhibited significantly increased range of motion for ankle joint after the intervention (p < 0.05), while the spatiotemporal gait variables were unchanged.","[{'ForeName': 'Kyun-Hee', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, Graduate School, YongIn University, Republic of Korea.'}, {'ForeName': 'Shin-Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, GangdDong University, 205ho, hongikgwan, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea. Electronic address: 3178310@naver.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104933']
2314,32687296,[The scientific rationale for the use of electroneurostimulation of the cervical sympathetic ganglia in patients with computer vision syndrome].,"A frequent reason for visiting an ophthalmologist for patients of working age is computer vision syndrome (CVS): statistics show that up to 90% of users of personal electronic computers (PCs) suffer from this disease. Therefore, the actual task of modern rehabilitation medicine and ophthalmology is the search for an effective and safe way to prevent and treat the CVS among employees of enterprises.
THE PURPOSE OF THIS STUDY


Was a scientific justification, an assessment of the effectiveness and safety of the use of electroneurostimulation (ENS) of the cervical sympathetic ganglia in patients with CVS.
MATERIAL AND METHODS


120 patients with the syndrome observed on an outpatient basis were examined. Patients were divided into 3 groups using simple randomization method. The 1st group (the main group - MG) included 39 patients who, against the background of gymnastics of the oculomotor muscles and muscles of the shoulder girdle, used ENS on the area of the sympathetic ganglia; in the 2nd group (group of comparison - GoC) included 41 patients who strictly performed the same muscle gymnastics (after every 2 hours of work with the PC); Group 3 (control group - CG) consisted of 40 patients who took an ENS course of exposure in placebo mode. In the dynamics, the stock of relative accommodation, near heterophory, tear production, threshold electrical sensitivity of the retina, electrolability of the optic nerve, contrast sensitivity, reading speed, print speed and accuracy and the level of subjective asthenopia were evaluated.
RESULTS


Initially, groups of patients with CVS did not differ among themselves in any of the investigated parameters. After a course of procedures in the MG, in contrast to the other two (GoC and CG), statistically significant positive shifts were revealed in relation to the selected endpoints, reflecting the severity of asthenopia, sensorineural, accommodative and oculomotor functions of the visual analyzer, as well as ophthalmoergonomics. Of the side effects of the procedures were recorded: moderate drowsiness (in 4 patients), a feeling of heaviness of the head (in 1 patient) and an increase in blood pressure (BP) by more than 15% of the initial (in 1 patient). They disappeared on their own and did not require withdrawal of treatment. A patient who noted a single increase in blood pressure subsequently received therapy every other day. Redness of the skin of the neck in the area of application of the electrodes was found with the same frequency in MG and CG.
CONCLUSION


The inclusion of ENS in the rehabilitation treatment of workers professionally using a personal computer significantly increases the effectiveness of therapeutic measures, which proves the appropriateness of applying the proposed technology in CVS. The therapeutic action of complex therapy is realized through the effect of the ENS on an important reflexogenic zone - the cervical sympathetic ganglia, the activation of which ensures the normalization of the central, peripheral and autonomic functioning of the visual analyzer. Analysis of the frequency of registration of side effects in patients of the three groups allows us to conclude that the technique is safe.",2020,"The inclusion of ENS in the rehabilitation treatment of workers professionally using a personal computer significantly increases the effectiveness of therapeutic measures, which proves the appropriateness of applying the proposed technology in CVS.","['patients with computer vision syndrome', '120 patients with the syndrome observed on an outpatient basis were examined', 'patients with CVS', '39 patients who, against the background of gymnastics of the oculomotor muscles and muscles of the shoulder girdle, used ENS on the area of the sympathetic ganglia; in the 2nd group (group of comparison - GoC) included 41 patients who strictly performed the same muscle gymnastics (after every 2 hours of work with the PC']","['electroneurostimulation (ENS', 'electroneurostimulation']","['blood pressure', 'stock of relative accommodation, near heterophory, tear production, threshold electrical sensitivity of the retina, electrolability of the optic nerve, contrast sensitivity, reading speed, print speed and accuracy and the level of subjective asthenopia', 'severity of asthenopia, sensorineural, accommodative and oculomotor functions of the visual analyzer, as well as ophthalmoergonomics', 'blood pressure (BP', 'feeling of heaviness of the head', 'moderate drowsiness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0028863', 'cui_str': 'Structure of extraocular muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0427245', 'cui_str': 'Shoulder girdle structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017071', 'cui_str': 'Sympathetic ganglion structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0585322', 'cui_str': 'Every two hours'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0029130', 'cui_str': 'Optic nerve structure'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0850001', 'cui_str': 'Heaviness of head'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",120.0,0.0192778,"The inclusion of ENS in the rehabilitation treatment of workers professionally using a personal computer significantly increases the effectiveness of therapeutic measures, which proves the appropriateness of applying the proposed technology in CVS.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Nikiforova', 'Affiliation': 'Ural State Medical University, Ekaterinburg, Russia.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusova', 'Affiliation': 'Pyatigorsk Medical and Pharmaceutical Institute - a branch of Volgograd State Medical University, Pyatigorsk, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Korotkikh', 'Affiliation': 'Ural State Medical University, Ekaterinburg, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fedorov', 'Affiliation': 'Ural State Medical University, Ekaterinburg, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kaysinova', 'Affiliation': 'Pyatigorsk Medical and Pharmaceutical Institute - a branch of Volgograd State Medical University, Pyatigorsk, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209704117']
2315,32696839,Comparison of the effects of voluntary and involuntary breath stacking techniques on respiratory mechanics and lung function patterns in tracheostomized patients: a randomized crossover clinical trial.,"OBJECTIVE


To compare the effects of voluntary breath stacking (VBS) and involuntary breath stacking (IBS) techniques on respiratory mechanics, lung function patterns, and inspiratory capacity in tracheostomized patients.
METHODS


This was a randomized crossover clinical trial involving 20 tracheostomized patients admitted to the ICU and submitted to the VBS and IBS techniques, in random order, with an interval of 5 h between each. Ten cycles of each technique were performed with an interval of 30 s between each cycle. In VBS, patients performed successive inspirations for up to 30 s through a one-way valve, whereas in IBS, successive slow insufflations were performed with a resuscitator bag until the pressure reached 40 cmH2O. Respiratory mechanics, inspiratory capacity, and the lung function pattern were evaluated before and after the interventions.
RESULTS


After IBS, there was an increase in static compliance (p = 0.007), which was also higher after IBS than after VBS (p = 0.03). There was no significant difference between the pre-VBS and post-VBS evaluations in terms of static compliance (p = 0.42). Inspiratory capacity was also greater after IBS than after VBS (2,420.7 ± 480.9 mL vs. 1,211.3 ± 562.8 mL; p < 0.001), as was airway pressure (38.3 ± 2.6 cmH2O vs. 25.8 ± 5.5 cmH2O; p < 0.001). There were no changes in resistance or lung function pattern after the application of either technique.
CONCLUSIONS


In comparison with VBS, IBS promoted greater inspiratory capacity and higher airway pressure, resulting in an increase in static compliance.",2020,"After IBS, there was an increase in static compliance (p = 0.007), which was also higher after IBS than after VBS (p = 0.03).","['tracheostomized patients', '20 tracheostomized patients admitted to the ICU and submitted to the VBS and IBS techniques, in random order, with an interval of 5 h between each']","['voluntary and involuntary breath stacking techniques', 'VBS, IBS', 'voluntary breath stacking (VBS) and involuntary breath stacking (IBS) techniques']","['resistance or lung function pattern', 'respiratory mechanics, lung function patterns, and inspiratory capacity', 'Inspiratory capacity', 'respiratory mechanics and lung function patterns', 'airway pressure', 'static compliance', 'inspiratory capacity and higher airway pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C1710178', 'cui_str': 'Breath stacking'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C1710178', 'cui_str': 'Breath stacking'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C1320796', 'cui_str': 'High airway pressure'}]",20.0,0.0237629,"After IBS, there was an increase in static compliance (p = 0.007), which was also higher after IBS than after VBS (p = 0.03).","[{'ForeName': 'Luciano Matos', 'Initials': 'LM', 'LastName': 'Chicayban', 'Affiliation': 'Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva, Institutos Superiores de Ensino do Centro Educacional Nossa Senhora Auxiliadora, Campos dos Goytacazes, RJ, Brasil.'}, {'ForeName': 'Alice Campos', 'Initials': 'AC', 'LastName': 'Hemétrio', 'Affiliation': 'Institutos Superiores de Ensino do Centro Educacional Nossa Senhora Auxiliadora, Campos dos Goytacazes, RJ, Brasil.'}, {'ForeName': 'Liz Tavares Rangel', 'Initials': 'LTR', 'LastName': 'Azevedo', 'Affiliation': 'Institutos Superiores de Ensino do Centro Educacional Nossa Senhora Auxiliadora, Campos dos Goytacazes, RJ, Brasil.'}]",Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia,['10.36416/1806-3756/e20190295']
2316,32690640,Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia.,"There remains an unmet need to address the substantial morbidity and mortality associated with severe community-acquired pneumonia (sCAP). Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and noninfectious inflammation. This blinded dose-escalation safety study involved non-intensive care unit (ICU) patients admitted for mild CAP and randomized 3:1 to receive adjunctive rhu-pGSN or placebo intravenously. Thirty-three subjects were treated: 8 in the single-dose phase and 25 in the multidose phase. For the single-dose phase, rhu-pGSN at 6 mg/kg of body weight was administered once. For the multidose phase, a daily rhu-pGSN dose of 6, 12, or 24 mg/kg was given on 3 consecutive days. Adverse events (AEs) were generally mild in both treatment groups irrespective of dose. The only serious AE (SAE) in the single-dose phase was a non-drug-related pneumonia in a rhu-pGSN recipient who died after institution of comfort care. One single-dose placebo recipient had a drug-related AE (maculo-papular rash). In the multidose phase, there were 2 SAEs in 1 placebo recipient, including a fatal pulmonary embolism. In the 18 rhu-pGSN recipients in the multidose phase, there were no serious or drug-related AEs, and nausea and increased blood pressure were each reported in 2 patients. The median rhu-pGSN half-life exceeded 17 h with all dosing regimens, and supraphysiologic levels were maintained throughout the 24-h dosing interval in the 2 highest dosing arms. Rhu-pGSN was well tolerated overall in CAP patients admitted to non-ICU beds, justifying a larger proof-of-concept trial in an ICU population admitted with sCAP. (This study has been registered at ClinicalTrials.gov under identifier NCT03466073.).",2020,Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and non-infectious inflammation.,"['Patients Hospitalized for Non-Severe Community-Acquired Pneumonia', 'Thirty-three subjects were treated: 8 in the single-dose phase and 25 in the multi-dose phase', 'non-ICU patients admitted for mild CAP']","['placebo', 'adjunctive rhu-pGSN or placebo', 'Recombinant human plasma gelsolin (rhu-pGSN', 'Recombinant Human Plasma Gelsolin']","['fatal pulmonary embolism', 'Adverse events (AEs', 'no serious or drug-related AEs, and nausea and increased blood pressure', 'supraphysiologic levels', 'median rhu-pGSN half-life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061187', 'cui_str': 'Gelsolin'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",33.0,0.124056,Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and non-infectious inflammation.,"[{'ForeName': 'Abla', 'Initials': 'A', 'LastName': 'Tannous', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA atannous@bioaegistx.com.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Levinson', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bolognese', 'Affiliation': 'Cytel Corporation, Waltham, Massachusetts, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Opal', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'DiNubile', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00579-20']
2317,32696964,The Evidence-Based Sexual Abuse Prevention Program: Strong With Sam.,"The present study was initiated to design and evaluate a sexual abuse prevention program for deaf and hard of hearing (DHH) children. This evidence-based prevention program is the first of its kind for DHH children. A total of 92 DHH children aged 8-12 years participated in the program ""STARK mit SAM"" (Strong with Sam, SmS), a program conducted in primary schools for DHH children in Germany. The program evaluation consisted of a pretest-posttest design. As per class, the subjects were assigned to either the experimental or the wait list control group. Participants from both groups were pretested for their knowledge about content related to the prevention of sexual abuse. The experimental group received the prevention program and both groups were posttested to examine the effects of the program. Additionally, the experimental group was tested again 6 months after the program. DHH children who participated in the SmS program showed a significant knowledge gain and a nonsignificant change in their anxiety. No significant factor affecting the children's significant knowledge gain was found. SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.",2020,"SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.","['DHH children who participated in the SmS program', 'DHH children', '92 DHH children aged 8-12\xa0years participated in the', 'DHH children in Germany', 'sexual abuse prevention program for deaf and hard of hearing (DHH) children']","['prevention program', 'program ""STARK mit SAM"" (Strong with Sam, SmS', 'SmS']","['knowledge gain', 'anxiety']","[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",92.0,0.0164724,"SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Urbann', 'Affiliation': 'Faculty of Human Sciences, Education and Rehabilitation of the Deaf and the Hard of Hearing, University of Cologne.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Bienstein', 'Affiliation': 'TU Dortmund University, Faculty of Rehabilitation Sciences, Rehabilitation and Education: Intellectual Disabilities.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kaul', 'Affiliation': 'Faculty of Human Sciences, Education and Rehabilitation of the Deaf and the Hard of Hearing, University of Cologne.'}]",Journal of deaf studies and deaf education,['10.1093/deafed/enaa019']
2318,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE


Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY


In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS


A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS


The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION


Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2021,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
2319,32698260,Effects of leucine-enriched essential amino acid supplementation on muscular fatigue and inflammatory cytokines in wheelchair basketball players.,"PURPOSE


This study aimed to investigate the effects of leucine-enriched essential amino acid (LEAA) supplementation on muscle fatigue and the level of inflammatory cytokines in wheelchair basketball players after a basketball game and interval training.
METHODS


Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test. These nine athletes received LEAA supplements (3 times 4.0 g/day) or placebo treatment in a double-blind, randomized, crossover study. We measured variables related to muscular fatigue and inflammatory response before the intense exercise and 4 days after recovery.
RESULTS


The significant effect of LEAA supplementation was inhibition of circulating IL-6 levels in the LEAA-treated group compared with the placebo group (P < .05). However, no changes were observed in the TNF-α and creatinine kinase levels. Moreover, analysis of variance analysis showed no significant difference in the relative values of muscle soreness. However, the effect size analysis with Cohen's d reported a significant improvement in the relative values of whole body and back muscle soreness.
CONCLUSION


Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.",2020,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"['wheelchair basketball players', 'wheelchair basketball players after a basketball game and interval training', 'Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test']","['LEAA supplements', 'leucine-enriched essential amino acid supplementation', 'LEAA', 'leucine-enriched essential amino acid (LEAA) supplementation', 'placebo']","['muscular fatigue and inflammatory cytokines', 'muscle soreness and IL-6 levels', 'muscle fatigue and the level of inflammatory cytokines', 'relative values of muscle soreness', 'relative values of whole body and back muscle soreness', 'circulating IL-6 levels', 'TNF-α and creatinine kinase levels', 'muscular fatigue and inflammatory response']","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}]",10.0,0.524042,Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Jae', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': ''}]",Physical activity and nutrition,['10.20463/pan.2020.0013']
2320,32701140,Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial.,"Importance


Pathologic complete response (pCR) is a known prognostic biomarker for long-term outcomes. The I-SPY2 trial evaluated if the strength of this clinical association persists in the context of a phase 2 neoadjuvant platform trial.
Objective


To evaluate the association of pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS) in subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents.
Design, Setting, and Participants


Multicenter platform trial of women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger. Women with tumors that were ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score were excluded. Participants were adaptively randomized to one of several different investigational regimens or control therapy within molecular subtypes from March 2010 through 2016. The analysis included participants with follow-up data available as of February 26, 2019.
Interventions


Standard-of-care neoadjuvant therapy consisting of taxane treatment with or without (as control) one of several investigational agents or combinations followed by doxorubicin and cyclophosphamide.
Main Outcomes and Measures


Pathologic complete response and 3-year EFS and DRFS.
Results


Of the 950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR. Three-year EFS and DRFS for patients who achieved pCR were both 95%. Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS.
Conclusions and Relevance


The 3-year outcomes from the I-SPY2 trial show that, regardless of subtype and/or treatment regimen, including 9 novel therapeutic combinations, achieving pCR after neoadjuvant therapy implies approximately an 80% reduction in recurrence rate. The goal of the I-SPY2 trial is to rapidly identify investigational therapies that may improve pCR when validated in a phase 3 confirmatory trial. Whether pCR is a validated surrogate in the sense that a therapy that improves pCR rate can be assumed to also improve long-term outcome requires further study.
Trial Registration


ClinicalTrials.gov Identifier: NCT01042379.",2020,"Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS.
","['participants with follow-up data available as of February 26, 2019', 'Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer', 'women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger', 'subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents', '950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR']","['taxane', 'pCR', 'doxorubicin and cyclophosphamide', 'control therapy']","['Hazard ratios', 'ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score', 'pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS', 'pCR rate', 'Measures\n\n\nPathologic complete response and 3-year EFS and DRFS', 'recurrence rate']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0455610', 'cui_str': 'H/O: surgery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.184284,"Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'DeMichele', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yau', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'Department of Pathology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Yunn-Yi', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, University of California, San Francisco.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Krings', 'Affiliation': 'Department of Pathology, University of California, San Francisco.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Pathology, University of Alabama Birmingham.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Department of Pathology, University of Alabama Birmingham.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Datnow', 'Affiliation': 'Department of Pathology, University of California, San Diego.'}, {'ForeName': 'Oluwole', 'Initials': 'O', 'LastName': 'Fadare', 'Affiliation': 'Department of Pathology, University of California, San Diego.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pambuccian', 'Affiliation': 'Department of Pathology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Adamson', 'Affiliation': 'Department of Pathology, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Sams', 'Affiliation': 'Department of Pathology, University of Colorado, Denver.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Mhawech-Fauceglia', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Magliocco', 'Affiliation': 'Department of Pathology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Rendi', 'Affiliation': 'Department of Anatomic Pathology, University of Washington, Seattle.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Sattar', 'Affiliation': 'Department of Pathology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Zeck', 'Affiliation': 'Department of Pathology, Georgetown University, Washington, DC.'}, {'ForeName': 'Idris T', 'Initials': 'IT', 'LastName': 'Ocal', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic Scottsdale, Scottsdale, Arizona.'}, {'ForeName': 'Ossama', 'Initials': 'O', 'LastName': 'Tawfik', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Kansas, Lawrence.'}, {'ForeName': 'Lauren Grasso', 'Initials': 'LG', 'LastName': 'LeBeau', 'Affiliation': 'Department of Pathology, University of Arizona, Tucson.'}, {'ForeName': 'Sunati', 'Initials': 'S', 'LastName': 'Sahoo', 'Affiliation': 'Department of Pathology, University of Texas Southwestern, Dallas.'}, {'ForeName': 'Tuyethoa', 'Initials': 'T', 'LastName': 'Vinh', 'Affiliation': 'Inova Pathology Institute, Inova Health System, Falls Church, Virginia.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Division of Hematology and Oncology, University of Alabama Birmingham.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Stringer-Reasor', 'Affiliation': 'Division of Hematology and Oncology, University of Alabama Birmingham.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Wallace', 'Affiliation': 'Department of Surgery, University of California, San Diego.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Medical Oncology, Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Boughey', 'Affiliation': 'Department of Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Ellis', 'Affiliation': 'Medical Oncology, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'Department of Medicine, University of Colorado, Denver.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': 'Surgery, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Medical Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Clark', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Hematology and Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Medical Oncology, Mayo Clinic Scottsdale, Scottsdale, Arizona.'}, {'ForeName': 'Qamar J', 'Initials': 'QJ', 'LastName': 'Khan', 'Affiliation': 'Medical Oncology, University of Kansas Medical Center, Lawrence.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Viscusi', 'Affiliation': 'Hematology/Oncology, University of Arizona, Tucson.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Euhus', 'Affiliation': 'Department of Surgery, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Edmiston', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, Virginia.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, California.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemmer', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Minetta C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Olufunmilayo', 'Initials': 'O', 'LastName': 'Olopade', 'Affiliation': 'Hematology and Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leyland-Jones', 'Affiliation': 'Avera Cancer Institute, Sioux Falls, South Dakota.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Stacy L', 'Initials': 'SL', 'LastName': 'Moulder', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'Medical Oncology, University of California, San Diego.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Medical Oncology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Helsten', 'Affiliation': 'Medical Oncology, University of California, San Diego.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beckwith', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Haugen', 'Affiliation': 'National Breast Cancer Coalition, Washington, DC.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""Van't Veer"", 'Affiliation': 'Department of Laboratory Medicine, University of California, San Francisco.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, Michigan.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Melisko', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Peterson', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Buxton', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Clennell', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Gillian L', 'Initials': 'GL', 'LastName': 'Hirst', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Singhrao', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Steeg', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Matthews', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Smita M', 'Initials': 'SM', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2535']
2321,32701188,"Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer.","BACKGROUND


Tegoprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders.
AIMS


To assess whether tegoprazan is non-inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers.
METHODS


In this phase 3, double-blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed.
RESULTS


In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4-week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug-related treatment-emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan-treated patients than in lansoprazole-treated patients.
CONCLUSIONS


Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers.",2020,Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks.,"['306 gastric ulcer patients', 'patients with gastric ulcers', 'gastric ulcer']","['tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole', 'lansoprazole', 'Tegoprazan', 'tegoprazan', 'tegoprazan 50\xa0mg, tegoprazan 100\xa0mg and lansoprazole']","['ulcer healing', 'cumulative healing rates', 'cumulative percentages of patients with healed ulcers', 'respective healing rates', 'Symptoms and safety', 'efficacy and safety', '4-week healing rates', 'incidence of drug-related treatment-emergent adverse events', 'serum gastrin concentration']","[{'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",306.0,0.118333,Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks.,"[{'ForeName': 'Yu Kyung', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Suck Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Iksan, Korea.'}, {'ForeName': 'Kee Myung', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Suwon, Korea.'}, {'ForeName': 'Tae Oh', 'Initials': 'TO', 'LastName': 'Kim', 'Affiliation': 'Busan, Korea.'}, {'ForeName': 'Soo-Heon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Jeong Seop', 'Initials': 'JS', 'LastName': 'Moon', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Goyang, Korea.'}, {'ForeName': 'Dae Hwan', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Yangsan, Korea.'}, {'ForeName': 'Gab Jin', 'Initials': 'GJ', 'LastName': 'Cheon', 'Affiliation': 'Gangneung, Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Chuncheon, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Incheon, Korea.'}, {'ForeName': 'Kwang Bum', 'Initials': 'KB', 'LastName': 'Cho', 'Affiliation': 'Daegu, Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Busan, Korea.'}, {'ForeName': 'Jong-Jae', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Byoung Kwan', 'Initials': 'BK', 'LastName': 'Son', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Hye-Kyung', 'Initials': 'HK', 'LastName': 'Jung', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': 'Incheon, Korea.'}, {'ForeName': 'Sung Kuk', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Daegu, Korea.'}, {'ForeName': 'Soo Teik', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Jeonju, Korea.'}, {'ForeName': 'Jae Myung', 'Initials': 'JM', 'LastName': 'Cha', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Ah Rong', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Seoul, Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15865']
2322,32690783,Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT).,"OBJECTIVE


To determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education.
METHODS


In this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care.
RESULTS


A total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%,  p  = 0.899) or 6 months (42% vs 43%,  p  = 0.435). Secondary outcomes did not differ between groups, with a threshold of  p  < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients.
CONCLUSION


We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right.
CLINICALTRIALSGOV IDENTIFIER


NCT02589886.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.",2020,"There was no difference in improvement of self-rated health at three months (44% vs 40%, p=0.899) or six months (42% vs 43%, p=0.435).","['motor Functional Neurological Disorder (SHIFT', 'Patients over 17 years of age with a functional motor symptom which caused distress or disability were included', 'patients with motor Functional Neurological Disorder', '186 patients']","['unguided education and self-help website in addition to usual care, or usual care only', 'unguided internet-based self-help and education']","['self-rated health on the Clinical Global Improvement (CGI) scale', 'Satisfaction', 'severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs and satisfaction with care', 'improvement of self-rated health']","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",186.0,0.125596,"There was no difference in improvement of self-rated health at three months (44% vs 40%, p=0.899) or six months (42% vs 43%, p=0.435).","[{'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Gelauff', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Rosmalen', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Dijk', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Ekkel', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Nielsen', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK.""}, {'ForeName': 'Marina A J', 'Initials': 'MAJ', 'LastName': 'Tijssen', 'Affiliation': ""From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK. m.a.j.de.koning-tijssen@umcg.nl.""}]",Neurology,['10.1212/WNL.0000000000010381']
2323,32690791,Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension.,"OBJECTIVE


To assess over 3 years of follow-up the effects of maintaining or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and safety measures in the open-label extension (OLE) phase of the pooled OPERA: I/II studies in relapsing multiple sclerosis.
METHODS


After 2 years of double-blind, controlled treatment, patients continued OCR (600 mg infusions every 24 weeks) or switched from interferon (IFN)-β-1a (44 μg 3 times weekly) to OCR when entering the OLE phase (3 years). Adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression (CDP)/improvement (CDP), brain MRI activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change were analyzed.
RESULTS


Of patients entering the OLE phase, 88.6% completed year 5. The cumulative proportion with 24-week CDP was lower in patients who initiated OCR earlier vs patients initially receiving IFN-β-1a (16.1% vs 21.3% at year 5;  p  = 0.014). Patients continuing OCR maintained and those switching from IFN-β-1a to OCR attained near complete and sustained suppression of new brain MRI lesion activity from years 3-5. Over the OLE phase, patients continuing OCR exhibited less whole brain volume loss from double-blind study baseline vs those switching from IFN-β-1a (-1.87% vs -2.15% at year 5;  p  < 0.01). Adverse events were consistent with past reports and no new safety signals emerged with prolonged treatment.
CONCLUSION


Compared with patients switching from IFN-β-1a, earlier and continuous OCR treatment up to 5 years provided sustained benefit on clinical and MRI measures of disease progression.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that earlier and continuous treatment with OCR provided sustained benefit on clinical and MRI outcomes of disease activity and progression compared with patients switching from IFN-β-1a. The study is rated Class III because of the initial treatment randomization disclosure that occurred after inclusion in OLE.
CLINICAL TRIAL IDENTIFIERS


NCT01247324/NCT01412333.",2020,This study provides Class III evidence that earlier and continuous treatment with ocrelizumab provided sustained benefit on clinical and MRI outcomes of disease activity and progression compared with patients switching from IFN β-1a.,[],"['OCR', 'maintaining or switching to ocrelizumab (OCR) therapy', 'interferon (IFN) β-1a', 'ocrelizumab']","['Adverse events', 'IFN β-1a', 'brain volume loss', 'new brain MRI lesion activity', 'cumulative proportion with 24-week CDP', 'Adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression/improvement (CDP/CDI), brain MRI activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change']",[],"[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0438357,This study provides Class III evidence that earlier and continuous treatment with ocrelizumab provided sustained benefit on clinical and MRI outcomes of disease activity and progression compared with patients switching from IFN β-1a.,"[{'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Shibeshih', 'Initials': 'S', 'LastName': 'Belachew', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA. harold.koendgen@roche.com.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Levesque', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Model', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Hubeaux', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Lahar', 'Initials': 'L', 'LastName': 'Mehta', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From the Department of Neurology (S.L.H.), University of California, San Francisco; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Switzerland; NeuroRx Research (D.L.A.); Departments of Neurology and Neurosurgery (D.L.A.), McGill University, Montreal, Canada; Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), University of Pennsylvania, Philadelphia; Department of Neurology (B.B.), CHU de Bordeaux, France; Department of Neurology (R.T.N.), Washington University School of Medicine, St. Louis, MO; Division of Neurology (A.T.), Department of Medicine, University of British Columbia, Vancouver, Canada; Department of Neurology (J.S.W.), McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth); F. Hoffmann-La Roche Ltd (S.B., H.K., M.M., F.M., S.H.), Basel, Switzerland; Genentech, Inc. (V.L., L.M.), South San Francisco, CA; Division of Neurology (X.M.), University of Toronto, Canada; and Department of Neurology-Neuroimmunology (X.M.), Vall d'Hebron University Hospital, Barcelona, Spain. During completion of the work related to this article, S.B. and L.M. were employees of F. Hoffmann-La Roche Ltd; current affiliations are Biogen (S.B.), Cambridge, MA; and Alder Biopharmaceuticals Inc. (L.M.), Bothell, WA.""}]",Neurology,['10.1212/WNL.0000000000010376']
2324,32697197,Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.,"BACKGROUND


Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence.
OBJECTIVE


This study aims to explore the mechanisms of action underpinning the intervention.
METHODS


A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis.
RESULTS


The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer.
CONCLUSIONS


The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797.",2020,"There was also evidence of Vassilev's mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit.","['adults with cystic fibrosis', '25 semi-structured interviews', '19 UK cystic fibrosis centers', 'two UK cystic fibrosis centers', 'adults with Cystic Fibrosis']","['complex intervention', 'health professional support']",['nebulizer adherence'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2.0,0.0567727,"There was also evidence of Vassilev's mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Drabble', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': ""O'Cathain"", 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Scott', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Madelynne A', 'Initials': 'MA', 'LastName': 'Arden', 'Affiliation': 'Centre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Keating', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Sheffield Adult CF Centre, Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Maguire', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wildman', 'Affiliation': 'Sheffield Adult CF Centre, Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16782']
2325,32696559,Rationale and design of a risk-guided strategy for reducing readmissions for acute decompensated heart failure: the Risk-HF study.,"AIMS


Heart failure (HF) readmission commonly arises owing to insufficient patient knowledge and failure of recognition of the early stages of recurrent fluid congestion. In previous work, we developed a score to predict short-term hospital readmission and showed that higher-risk patients benefit most from a disease management programme (DMP) that included enhancing knowledge and education by a nurse. We aim to evaluate the effectiveness of a novel, nurse-led HF DMP in selected patients at high risk of short-term hospital readmission, using ultrasound-guided diuretic management and artificial intelligence to enhance HF knowledge in an outpatient setting.
METHODS AND RESULTS


Risk-HF is a prospective multisite randomized controlled trial that will allocate 404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30 days, into risk-guided nurse intervention (DMP-Plus group) compared with usual care. Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based 'digital health coach'; and (vi) exercise guidance through the digital coach. Usual care involves standard post-discharge hospital care. The primary outcome is reduced death and/or hospital readmissions at 30 days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement. Assuming that our intervention will reduce readmissions and/or deaths by 50%, with a 1:1 ratio of intervention vs. usual care, we plan to randomize 404 patients to show a difference at a statistical power of 80%, using a two-sided alpha of 0.05. We anticipate this recruitment will be achieved by screening 2020 hospitalized HF patients for eligibility. An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21). A pilot of the use of HHU by nurses showed that it was feasible and accurate.
CONCLUSIONS


The Risk-HF trial will evaluate the effectiveness of a risk-guided intervention to improve HF outcomes and will evaluate the efficacy of trained HF nurses delivering a fluid management protocol that is guided by lung ultrasound with an HHU at point of care.",2020,"An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21).","['404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30\xa0days, into risk', '2020 hospitalized HF patients for eligibility', 'acute decompensated heart failure', '21 HF patients, age\xa0>\xa075\xa0years', 'selected patients at high risk of short-term hospital readmission, using']","['novel, nurse-led HF DMP', ""Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based 'digital health coach'; and (vi) exercise guidance through the digital coach"", 'risk-guided strategy', 'ultrasound-guided diuretic management and artificial intelligence', 'guided nurse intervention (DMP-Plus group) compared with usual care']","['reduced death and/or hospital readmissions at 30\xa0days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement', 'quality of life (13 of 21), self-care (12 of 21), and HF knowledge', 'readmissions and/or deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1320368', 'cui_str': 'Post-discharge follow-up'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4761127', 'cui_str': 'Drug titration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3266241', 'cui_str': 'Transition of care'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",21.0,0.07804,"An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Zisis', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Huynh', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Faculty of Medicine, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Neil', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Carrington', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Jocasta', 'Initials': 'J', 'LastName': 'Ball', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Maguire', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Marwick', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Vic., 3004, Australia.'}]",ESC heart failure,['10.1002/ehf2.12897']
2326,32696600,The detrimental effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.,"AIMS


A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.
METHODS AND RESULTS


We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease.
CONCLUSIONS


The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.",2020,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","['heart failure patients', 'patients with cardiovascular diseases, such as heart failure', '26 heart failure patients']",['COVID-19 nationwide quarantine'],['habitual physical activity'],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0344114,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vetrovsky', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Frybova', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Gant', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Semerad', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cimler', 'Affiliation': 'Faculty of Science, University of Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Bunc', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Siranec', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Miklikova', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Vesely', 'Affiliation': 'Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Griva', 'Affiliation': 'Department of Cardiology, Tomas Bata Regional Hospital in Zlin, Zlin, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Precek', 'Affiliation': 'Department of Internal Medicine I-Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Pelouch', 'Affiliation': '1st Department of Internal Medicine-Cardioangiology, University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Parenica', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}]",ESC heart failure,['10.1002/ehf2.12916']
2327,32698532,A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18-50 Years of Age.,"Inactivated influenza vaccines efficacy is variable and often poor. We conducted a phase 1 trial (NCT02188810), to assess the safety and immunogenicity of a novel nanoparticle Toll-like receptor 7/8 agonist adjuvant (Papaya Mosaic Virus) at different dose levels combined with trivalent influenza vaccine in healthy persons 18-50 years of age. Hemagglutination-inhibition assays, antibody to Influenza A virus nucleoprotein and peripheral blood mononuclear cells for measurement of interferon-gamma ELISPOT response to influenza antigens, Granzyme B and IFNγ:IL-10 ratio were measured. The most common adverse events were transient mild to severe injection site pain and no safety signals were observed. A dose-related adjuvant effect was observed. Geometric mean hemagglutination-inhibition titers increased at day 28 in most groups and waned over time, but fold-antibody responses were poor in all groups. Cell mediated immunity results were consistent with humoral responses. The Papaya Mosaic Virus adjuvant in doses of 30 to 240 µg combined with reduced influenza antigen content was safe with no signals up to 3 years after vaccination. A dose-related adjuvant effect was observed and immunogenicity results suggest that efficacy study should be conducted in influenza antigen-naïve participants.",2020,"Geometric mean hemagglutination-inhibition titers increased at day 28 in most groups and waned over time, but fold-antibody responses were poor in all groups.","['healthy persons 18-50 years of age', 'Healthy Adults 18-50 Years of Age']","['novel nanoparticle Toll-like receptor 7/8 agonist adjuvant (Papaya Mosaic Virus) at different dose levels combined with trivalent influenza vaccine', 'Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine']","['Geometric mean hemagglutination-inhibition titers', 'safety and immunogenicity', 'Safety and Reactogenicity', 'severe injection site pain and no safety signals', 'Granzyme B and IFNγ:IL-10 ratio']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1000301', 'cui_str': 'Papaya mosaic virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032092', 'cui_str': 'Plant virus'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0061878', 'cui_str': 'Granzyme B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0384984,"Geometric mean hemagglutination-inhibition titers increased at day 28 in most groups and waned over time, but fold-antibody responses were poor in all groups.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Pastural', 'Affiliation': 'Pan-Provincial Vaccine Enterprise (PREVENT), 120 Veterinary Road, Saskatoon, SK S7N 5E3, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'ElSherif', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'MacKinnon-Cameron', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre, Nova Scotia Health Authority), 5850 University Avenue, Halifax, NS B3K 6R8, Canada.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Grange', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (C.R.H.U.M.), 900 rue St-Denis, Tour Viger, Montreal, QC H2X 0A9, Canada.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Thibodeau', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (C.R.H.U.M.), 900 rue St-Denis, Tour Viger, Montreal, QC H2X 0A9, Canada.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Cailhier', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (C.R.H.U.M.), 900 rue St-Denis, Tour Viger, Montreal, QC H2X 0A9, Canada.""}, {'ForeName': 'Rejean', 'Initials': 'R', 'LastName': 'Lapointe', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (C.R.H.U.M.), 900 rue St-Denis, Tour Viger, Montreal, QC H2X 0A9, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McElhaney', 'Affiliation': 'Northern Ontario School of Medicine, 41 Ramsey Lake Health Centre, Thunder Bay, ON P3E 5J1, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Pan-Provincial Vaccine Enterprise (PREVENT), 120 Veterinary Road, Saskatoon, SK S7N 5E3, Canada.'}, {'ForeName': 'Marilène', 'Initials': 'M', 'LastName': 'Bolduc', 'Affiliation': 'Department of Microbiology, Infectiology and Immunology, Laval University, 1050, avenue de la Médecine, bureau 4633, QC G1V 0A6, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Laliberté-Gagné', 'Affiliation': 'Department of Microbiology, Infectiology and Immunology, Laval University, 1050, avenue de la Médecine, bureau 4633, QC G1V 0A6, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Leclerc', 'Affiliation': 'Department of Microbiology, Infectiology and Immunology, Laval University, 1050, avenue de la Médecine, bureau 4633, QC G1V 0A6, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Savard', 'Affiliation': 'Department of Molecular Biology, Medical Biology and Pathology, Laval University, 2705 boulevard Laurier P-09835, QC PQ G1V 4G2, Canada.'}]",Vaccines,['10.3390/vaccines8030393']
2328,32696742,[Palmitic acid decreases phosphorylation of eNOS Ser1177 by activating protein phosphatase 2C (PP2C) of human umbilical vein endothelial cells].,"Objective To investigate the roles of protein phosphatase 2C (PP2C) activated by palmitic acid (PA) in the phosphorylation modulation of endothelial nitric oxide (eNOS) at the site of serine 1177 (eNOS Ser1177) in human umbilical vein endothelial cells (HUVECs). Methods HUVECs were randomly divided into control group, PA group, specific PP2C inhibitor sanguinarine (San) combined with PA group and PP2Cα specific small interference RNA (siRNA) transfection group. The protein expression of total eNOS, phosphorylated eNOS Ser1177 and PP2Cα were detected by Western blotting. The intracellular NO content was measured by DAF-FM DA. The co-localization of eNOS protein and PP2C protein was observed by co-immunoprecipitation. Results Compared with the control group, the phosphorylation levels of eNOS Ser1177 and NO content decreased significantly in the PA group. The PP2C inhibitor sanguinarine reversed PA-induced decrease of eNOS Ser1177 phosphorylation level and NO content. The phosphorylation levels of eNOS Ser1177 were enhanced dramatically after PP2Cα protein was knocked down by specific siRNA. The eNOS protein and PP2C protein co-localized in endothelial cells. Conclusion PA reduces the phosphorylation level of endothelial eNOS Ser1177 in HUVECs by activating PP2C.",2020,"Compared with the control group, the phosphorylation levels of eNOS Ser1177 and NO content decreased significantly in the PA group.",['human umbilical vein endothelial cells (HUVECs'],"['Palmitic acid', 'PA group, specific PP2C inhibitor sanguinarine (San) combined with PA group and PP2Cα specific small interference RNA (siRNA) transfection group', 'protein phosphatase 2C (PP2C) activated by palmitic acid (PA']","['phosphorylation levels of eNOS Ser1177', 'co-localization of eNOS protein and PP2C protein', 'phosphorylation levels of eNOS Ser1177 and NO content', 'protein expression of total eNOS, phosphorylated eNOS Ser1177 and PP2Cα']","[{'cui': 'C3179121', 'cui_str': 'Endothelial Cells, Human Umbilical Vein'}]","[{'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031678', 'cui_str': 'Phosphoric monoester hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0074027', 'cui_str': 'sanguinarine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0040669', 'cui_str': 'Transfection'}, {'cui': 'C0247248', 'cui_str': 'Ptc2 Phosphatase'}]","[{'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031678', 'cui_str': 'Phosphoric monoester hydrolase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0170423,"Compared with the control group, the phosphorylation levels of eNOS Ser1177 and NO content decreased significantly in the PA group.","[{'ForeName': 'Jingjie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Yanbei', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China.'}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Department of Pathophysiology, Basic Medicine School, Guizhou Medical University, Key Laboratory of Drug Research and Pathogenesis of Common Chronic Diseases in Guizhou Province, Guizhou Medical University, Guiyang 550025, China. *Corresponding author, E-mail: dqlu91@hotmail.com.'}]",Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology,[]
2329,32701129,Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial.,"Importance


The role of locoregional radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma (mNPC) is unclear.
Objective


To investigate the efficacy and safety of locoregional radiotherapy in de novo mNPC.
Design, Setting, and Participants


Patients with biopsy-proven mNPC, who demonstrated complete or partial response (RECIST v1.1) following 3 cycles of cisplatin and fluorouracil chemotherapy, were enrolled. Eligible patients were randomly assigned (1:1) to receive either chemotherapy plus radiotherapy or chemotherapy alone. Overall, 126 of 173 patients screened were eligible to the study, and randomized to chemotherapy plus radiotherapy (n = 63) or chemotherapy alone (n = 63). Median (IQR) follow-up duration was 26.7 (17.2-33.5) months.
Interventions


The chemotherapy regimens were fluorouracil continuous intravenous infusion at 5 g/m2 over 120 hours and 100 mg/m2 intravenous cisplatin on day 1, administered every 3 weeks for 6 cycles. Patients assigned to the chemotherapy plus radiotherapy group received intensity-modulated radiotherapy (IMRT) after chemotherapy.
Main Outcomes and Measures


The primary end point of the study was overall survival (OS). The secondary end point was progression-free survival (PFS) and safety.
Results


Overall, 126 patients were enrolled (105 men [83.3%] and 21 women [16.7%]; median [IQR] age, 46 [39-52] years). The 24-month OS was 76.4% (95% CI, 64.4%-88.4%) in the chemotherapy plus radiotherapy group, compared with 54.5% (95% CI, 41.0%-68.0%) in the chemotherapy-alone group. The study met its primary end point of improved OS (stratified hazard ratio [HR], 0.42; 95% CI, 0.23-0.77; P = .004) in favor of chemotherapy plus radiotherapy. Progression-free survival was also improved in the chemotherapy plus radiotherapy group compared with the chemotherapy-alone group (stratified HR, 0.36; 95% CI, 0.23-0.57). No significant differences in acute hematological or gastrointestinal toxic effects were observed between the treatment arms. The frequency of acute grade 3 or higher dermatitis, mucositis, and xerostomia was 8.1%, 33.9%, and 6.5%, respectively, in the chemotherapy plus radiotherapy group. The frequency of late severe grade 3 or higher hearing loss and trismus was 5.2% and 3.4%, respectively, in the chemotherapy plus radiotherapy group.
Conclusions and Relevance


In this randomized clinical trial, radiotherapy added to chemotherapy significantly improved OS in chemotherapy-sensitive patients with mNPC.
Trial Registration


ClinicalTrials.gov Identifier: NCT02111460.",2020,"The 24-month OS was 76.4% (95% CI, 64.4%-88.4%) in the chemotherapy plus radiotherapy group, compared with 54.5% (95% CI, 41.0%-68.0%) in the chemotherapy-alone group.","['De Novo Metastatic Nasopharyngeal Carcinoma', '126 patients were enrolled (105 men [83.3%] and 21 women [16.7%]; median [IQR] age, 46 [39-52] years', 'Participants\n\n\nPatients with biopsy-proven mNPC, who demonstrated complete or partial response (RECIST v1.1) following 3 cycles of', 'chemotherapy-sensitive patients with mNPC', '126 of 173 patients screened were eligible to the study, and randomized to', 'patients with de novo metastatic nasopharyngeal carcinoma (mNPC', 'Eligible patients']","['locoregional radiotherapy', 'chemotherapy plus radiotherapy', 'chemotherapy plus radiotherapy or chemotherapy alone', 'radiotherapy', 'Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone', 'cisplatin', 'cisplatin and fluorouracil chemotherapy', 'chemotherapy alone', 'intensity-modulated radiotherapy (IMRT) after chemotherapy', 'chemotherapy']","['progression-free survival (PFS) and safety', 'Efficacy and Safety', '24-month OS', 'OS', 'frequency of acute grade 3 or higher dermatitis, mucositis, and xerostomia', 'Median (IQR) follow-up duration', 'frequency of late severe grade 3 or higher hearing loss and trismus', 'overall survival (OS', 'Progression-free survival', 'acute hematological or gastrointestinal toxic effects']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",126.0,0.264303,"The 24-month OS was 76.4% (95% CI, 64.4%-88.4%) in the chemotherapy plus radiotherapy group, compared with 54.5% (95% CI, 41.0%-68.0%) in the chemotherapy-alone group.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'You-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'He', 'Affiliation': 'Department of Radiation Oncology, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Yi-Shan', 'Initials': 'YS', 'LastName': 'Wu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China.'}, {'ForeName': 'Hong-Dan', 'Initials': 'HD', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science, Guangzhou 510080, China.""}, {'ForeName': 'Chong-Yang', 'Initials': 'CY', 'LastName': 'Duan', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Sze Huey', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'Cao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.'}, {'ForeName': 'Yu-Long', 'Initials': 'YL', 'LastName': 'Xie', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yi-Nuan', 'Initials': 'YN', 'LastName': 'Zhang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rou', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Meng-Xia', 'Initials': 'MX', 'LastName': 'Zhang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Hua', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Zhuang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou 510080, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.'}, {'ForeName': 'Melvin Lee Kiang', 'Initials': 'MLK', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology and Medical Sciences, National Cancer Centre Singapore, 169610, Singapore.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1808']
2330,32251400,Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers.,"PD-1 plus CTLA-4 blockade is highly effective in advanced-stage, mismatch repair (MMR)-deficient (dMMR) colorectal cancers, yet not in MMR-proficient (pMMR) tumors. We postulated a higher efficacy of neoadjuvant immunotherapy in early-stage colon cancers. In the exploratory NICHE study (ClinicalTrials.gov: NCT03026140), patients with dMMR or pMMR tumors received a single dose of ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib. The primary objective was safety and feasibility; 40 patients with 21 dMMR and 20 pMMR tumors were treated, and 3 patients received nivolumab monotherapy in the safety run-in. Treatment was well tolerated and all patients underwent radical resections without delays, meeting the primary endpoint. Of the patients who received ipilimumab + nivolumab (20 dMMR and 15 pMMR tumors), 35 were evaluable for efficacy and translational endpoints. Pathological response was observed in 20/20 (100%; 95% exact confidence interval (CI): 86-100%) dMMR tumors, with 19 major pathological responses (MPRs, ≤10% residual viable tumor) and 12 pathological complete responses. In pMMR tumors, 4/15 (27%; 95% exact CI: 8-55%) showed pathological responses, with 3 MPRs and 1 partial response. CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors. These data indicate that neoadjuvant immunotherapy may have the potential to become the standard of care for a defined group of colon cancer patients when validated in larger studies with at least 3 years of disease-free survival data.",2020,CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors.,"['early-stage colon cancers', '40 patients with 21 dMMR and 20 pMMR tumors', 'patients with dMMR or pMMR tumors']","['ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib', 'Neoadjuvant immunotherapy', 'CD8 + PD-1 +  T cell infiltration', 'ipilimumab\u2009+\u2009nivolumab', 'nivolumab monotherapy', 'neoadjuvant immunotherapy', 'PD-1 plus CTLA-4 blockade']","['safety and feasibility', 'Pathological response', 'pathological responses']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",40.0,0.120671,CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors.,"[{'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Chalabi', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. m.chalabi@nki.nl.'}, {'ForeName': 'Lorenzo F', 'Initials': 'LF', 'LastName': 'Fanchi', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Krijn K', 'Initials': 'KK', 'LastName': 'Dijkstra', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'José G', 'Initials': 'JG', 'LastName': 'Van den Berg', 'Affiliation': 'Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Arend G', 'Initials': 'AG', 'LastName': 'Aalbers', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lopez-Yurda', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Geerard L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Snaebjornsson', 'Affiliation': 'Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Mertz', 'Affiliation': 'Bioimaging Facility, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Veninga', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Bounova', 'Affiliation': 'Oncode Institute, Utrecht, the Netherlands.'}, {'ForeName': 'Annegien', 'Initials': 'A', 'LastName': 'Broeks', 'Affiliation': 'Core Facility Molecular Pathology & Biobanking, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Regina G', 'Initials': 'RG', 'LastName': 'Beets-Tan', 'Affiliation': 'GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'de Wijkerslooth', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Anja U', 'Initials': 'AU', 'LastName': 'van Lent', 'Affiliation': 'Gastroenterology & Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Hendrik A', 'Initials': 'HA', 'LastName': 'Marsman', 'Affiliation': 'Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Nuijten', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels F', 'Initials': 'NF', 'LastName': 'Kok', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kuiper', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Wieke H', 'Initials': 'WH', 'LastName': 'Verbeek', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kok', 'Affiliation': 'Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Van Leerdam', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton N', 'Initials': 'TN', 'LastName': 'Schumacher', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Emile E', 'Initials': 'EE', 'LastName': 'Voest', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. e.voest@nki.nl.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Haanen', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Nature medicine,['10.1038/s41591-020-0805-8']
2331,32702468,Predicting post one-year durability of glucose-lowering monotherapies in patients with newly-diagnosed type 2 diabetes mellitus - A MASTERMIND precision medicine approach (UKPDS 87).,"AIMS


Predicting likely durability of glucose-lowering therapies for people with type 2 diabetes (T2D) could help inform individualised therapeutic choices.
METHODS


We used data from UKPDS patients with newly-diagnosed T2D randomised to first-line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin. In 2339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥ 7.5% or requiring second-line therapy). Model validation was performed using bootstrap sampling.
RESULTS


Follow-up was median (IQR) 11.0 (8.0-14.0) years. Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years. Time-to-monotherapy-failure was predicted primarily by HbA 1c  and BMI values-with other risk factors varying by type of monotherapy-with predictions to within ±2.5 years for 55%-60%-56% and 57% of the chlorpropamide-glibenclamide-basal insulin and metformin monotherapy cohorts respectively.
CONCLUSIONS


Post one-year glycaemic durability can be predicted robustly in individuals with newly-diagnosed T2D who achieve HbA 1c values  < 7.5% one year after commencing traditional monotherapies. Such information could be used to help guide glycaemic management for individual patients.",2020,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"['2,339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥7.5% or requiring second-line therapy', 'people with type 2 diabetes ', 'Patients with Newly-diagnosed Type 2 Diabetes Mellitus', 'UKPDS patients with newly-diagnosed T2D randomised to first']","['chlorpropamide-glibenclamide-basal insulin or metformin', 'line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin', 'glucose-lowering therapies', 'Glucose-lowering Monotherapies']","['Monotherapy-failure', 'Time-to-monotherapy-failure']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0008287', 'cui_str': 'Chlorpropamide'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2339.0,0.0533422,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"[{'ForeName': 'Olorunsola F', 'Initials': 'OF', 'LastName': 'Agbaje', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK. Electronic address: olorunsola.agbaje@dtu.ox.ac.uk.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Jones', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Medical Research Institute, University of Dundee, Dundee, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108333']
2332,32702101,Nonsteroidal Anti-inflammatory Drugs vs Cognitive Behavioral Therapy for Arthritis Pain: A Randomized Withdrawal Trial.,"Importance


Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for knee osteoarthritis. However, they are associated with uncertain long-term clinical benefit and significant toxic effects.
Objective


To evaluate whether discontinuing NSAIDs and engaging in a telephone-based cognitive behavioral therapy (CBT) program is noninferior to continuing NSAIDs for patients with knee osteoarthritis.
Design, Setting, and Participants


The Stopping NSAIDs for Arthritis Pain multicenter randomized withdrawal trial was conducted for 364 patients taking NSAIDs for knee osteoarthritis pain on most days of the week for at least 3 months between September 1, 2013, and September 30, 2018. Analysis was performed on an intent-to-treat basis.
Interventions


Participants discontinued their current NSAID and took 15 mg per day of meloxicam daily during a 2-week run-in period. Those who remained eligible were randomized in a 1:1 ratio to receive meloxicam or placebo for 4 weeks (blinded phase 1). Participants receiving meloxicam then continued this medication for 10 weeks, while those receiving placebo participated in a 10-week CBT program (unblinded phase 2).
Main Outcomes and Measures


The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 4 weeks with the noninferiority margin set at 1. Secondary outcomes included the area under the curve of the pain score after 4 weeks as well as the WOMAC pain score, area under the curve of the pain score, WOMAC disability score, and global impression of change after treatment at 14 weeks.
Results


A total of 180 participants (161 men; mean [SD] age, 58. 2 [11.8] years) were randomized to receive placebo followed by CBT, and a total of 184 participants (154 men; mean [SD] age, 58.5 [10.0] years) were randomized to receive meloxicam. After adjustment for baseline pain and study site, the estimated mean difference in WOMAC pain score between the placebo and meloxicam groups after 4 weeks was 1.4 (95% CI, 0.8-2.0; noninferiority test P = .92). At week 14, the adjusted mean difference in WOMAC pain score between the placebo (followed by CBT) and meloxicam groups was 0.8 (95% CI, 0.2-1.4; noninferiority P = .28). There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks.
Conclusions and Relevance


Among patients with knee osteoarthritis, placebo and CBT (after placebo) are inferior to meloxicam. However, the WOMAC pain score differences between the 2 groups were small, and there were no statistically significant differences in participants' global impression of change or function after 14 weeks.
Trial Registration


ClinicalTrials.gov Identifier: NCT01799213.",2020,"There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks.
","['Arthritis Pain', '184 participants (154 men; mean [SD] age, 58.5 [10.0] years', '180 participants (161 men; mean [SD] age, 58', '364 patients taking NSAIDs for knee osteoarthritis pain on most days of the week for at least 3 months between September 1, 2013, and September 30, 2018', 'patients with knee osteoarthritis']","['discontinuing NSAIDs and engaging in a telephone-based cognitive behavioral therapy (CBT) program', 'meloxicam', 'placebo followed by CBT', 'Nonsteroidal Anti-inflammatory Drugs vs Cognitive Behavioral Therapy', 'Nonsteroidal anti-inflammatory drugs (NSAIDs', 'placebo and CBT (after placebo', 'meloxicam or placebo', 'placebo']","['Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score', 'area under the curve of the pain score after 4 weeks as well as the WOMAC pain score, area under the curve of the pain score, WOMAC disability score, and global impression of change', 'extremity disability', 'global impression of change', 'WOMAC pain score differences', 'WOMAC pain score']","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0585023', 'cui_str': 'Days of the week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",180.0,0.518584,"There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks.
","[{'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Fraenkel', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suter', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Dubreuil', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'North Florida/South Georgia Veterans Health System, Gainesville, Florida.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Najem', 'Affiliation': 'Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brennan', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Corn', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kerns', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Goulet', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2821']
2333,32702169,Randomised clinical trial: significant biochemical and colonic transit effects of the farnesoid X receptor agonist tropifexor in patients with primary bile acid diarrhoea.,"BACKGROUND


In primary bile acid diarrhoea, feedback by farnesoid X receptor (FXR) and fibroblast growth hormone 19 (FGF19) on hepatic bile acid production is impaired.
AIMS


To evaluate the safety, mechanisms and efficacy of negative feedback by FXR activation with tropifexor, a non-bile acid FXR agonist, in patients with primary bile acid diarrhoea.
METHODS


In this double-blind, multicentre, randomised, cross-over study, patients received tropifexor 60 µg or placebo once daily for 14 days in each of two treatment periods. Primary objectives included tropifexor safety and tolerability, and on stool frequency and form. Other assessments included pharmacokinetic and pharmacodynamic measures, biochemical markers and gastrointestinal transit.
RESULTS


Twenty patients (tropifexor 60 µg/placebo [N = 10]; placebo/tropifexor 60 µg [N = 10]) were enrolled. Adverse event rates were lower with tropifexor vs placebo (52.9% vs 73.7%). No patient had pruritus during tropifexor intake. There were no significant differences in stool frequency, stool form or loperamide use between treatments. Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12. At day 12, tropifexor caused reduction in peak total bile acid concentration (33%, P = 0.032) and exposure (36%, P = 0.005). Moreover, tropifexor showed a significant increase in ascending colon half-emptying time (P = 0.036).
CONCLUSIONS


Tropifexor 60 µg once daily had acceptable safety and tolerability. Changes in FGF19 and C4 showed effective target engagement; however, higher doses may be required to observe stool frequency changes. Slowing of ascending colon emptying suggests therapeutic potential of tropifexor in patients with primary bile acid diarrhoea. ClinicalTrials.gov number: NCT02713243.",2020,Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12.,"['60\xa0µg [N\xa0=\xa010]) were enrolled', 'patients with primary bile acid diarrhoea', 'Twenty patients (tropifexor 60\xa0µg']","['placebo/tropifexor', 'placebo', 'tropifexor 60\xa0µg or placebo', 'farnesoid X receptor agonist tropifexor', 'tropifexor vs placebo']","['stool frequency, stool form or loperamide use', 'tropifexor safety and tolerability, and on stool frequency and form', 'acceptable safety and tolerability', 'Plasma tropifexor concentrations', 'peak total bile acid concentration', 'Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels', 'Adverse event rates', 'pharmacokinetic and pharmacodynamic measures, biochemical markers and gastrointestinal transit', 'ascending colon half-emptying time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}, {'cui': 'C4521707', 'cui_str': 'Farnesoid X receptor agonist'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0017191', 'cui_str': 'Gastrointestinal transit study'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.357184,Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ibironke', 'Initials': 'I', 'LastName': 'Oduyebo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Koeun', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Bhad', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Badman', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Sanders', 'Affiliation': 'The Academic Unit of Gastroenterology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Julian R F', 'Initials': 'JRF', 'LastName': 'Walters', 'Affiliation': 'Division of Digestive Diseases, Imperial College London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15967']
2334,32701419,A Randomized and Controlled Acceptability Trial of an Internet-based Therapy among Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders.,"OBJECTIVES


Technology-assisted treatment (TAT) holds promise for innovative assessment, prevention, and treatment of substance use disorders (SUD). The widespread access to TAT makes it a potentially cost-effective and inventive option available for delivery in multiple settings. This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  Methods:  Eligible participants were nonpsychotic, voluntary patients with self-reported drug or alcohol use in the 30 days prior to admission. They were randomly assigned to treatment as usual (TAU,  n  = 47) or TAU + TES ( n  = 48). Acceptability of this Internet-based intervention was assessed by observed utilization and self-report.  Results:  The TAU + TES group (# analyzed = 41) completed a mean total of 5.5 ( SEM  = 0.8) modules with about one module per day while hospitalized and rated TES highly on several constructs of acceptability, including novelty, usefulness and ease of understanding.  Conclusions:  These findings support further exploration of TAT for treatment expansion in a high acuity, dual diagnosis population and indicate the value of future research on efficacy.  ClinicalTrials.gov Identifier:  NCT02674477.",2020,This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  ,"['hospitalized dual diagnosis patients with SUDs and other psychiatric disorders', 'Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders', 'Eligible participants were nonpsychotic, voluntary patients with self-reported drug or alcohol use in the 30 days prior to admission']","['Internet-based Therapy', 'TAT', 'web-based Therapeutic Education System (TES', 'usual (TAU,  n \u2009=\u200947) or TAU\u2009+\u2009TES', 'Technology-assisted treatment (TAT']","['acceptability, including novelty, usefulness and ease of understanding']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0580276', 'cui_str': 'Informal patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.0530963,This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  ,"[{'ForeName': 'Alexis S', 'Initials': 'AS', 'LastName': 'Hammond', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Antoine', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Strain', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2020.1794094']
2335,32706122,Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial.,"AIM


This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle.
METHOD


The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient.
RESULTS


Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A.
INTERPRETATION


The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A.
WHAT THIS PAPER ADDS


Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success.",2020,Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3).,"['severe drooling after one treatment cycle', 'Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective', 'Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y', 'drooling']","['Botulinum neurotoxin', 'botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands', 'botulinum neurotoxin A versus surgery']","['Cost-effectiveness', 'Average costs', 'ICER', 'subjective visual analogue scale for the severity of drooling or the objective drooling quotient', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0038556', 'cui_str': 'Submandibular salivary apparatus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",53.0,0.0603741,Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3).,"[{'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Bekkers', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'van Ulsen', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'M M Adang', 'Affiliation': 'Department for Health Evidence Rehabilitation, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'R T Scheffer', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'J A van den Hoogen', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14636']
2336,32710165,Change in Dynamic Hyperinflation After Bronchoscopic Lung Volume Reduction in Patients with Emphysema.,"BACKGROUND AND PURPOSE


In patients with severe emphysema, dynamic hyperinflation is superimposed on top of already existing static hyperinflation. Static hyperinflation reduces significantly after bronchoscopic lung volume reduction (BLVR). In this study, we investigated the effect of BLVR compared to standard of care (SoC) on dynamic hyperinflation.
METHODS


Dynamic hyperinflation was induced by a manually paced tachypnea test (MPT) and was defined by change in inspiratory capacity (IC) measured before and after MPT. Static and dynamic hyperinflation measurements were performed both at baseline and 6 months after BLVR with endobronchial valves or coils (treatment group) or SoC (control group).
RESULTS


Eighteen patients underwent BLVR (78% female, 57 (43-67) years, FEV 1  25(18-37) %predicted, residual volume 231 (182-376) %predicted). Thirteen patients received SoC (100% female, 59 (44-74) years, FEV 1  25 (19-37) %predicted, residual volume 225 (152-279) %predicted. The 6 months median change in dynamic hyperinflation in the treatment group was: + 225 ml (range - 113 to + 803) (p < 0.01) vs 0 ml (- 1067 to + 500) in the control group (p = 0.422). An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
CONCLUSION


Bronchoscopic lung volume reduction increases the ability for dynamic hyperinflation in patients with severe emphysema. We propose this is a consequence of improved static hyperinflation.",2020,"An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
","['patients with severe emphysema', 'Patients with Emphysema']","['endobronchial valves or coils (treatment group) or SoC (control group', 'Bronchoscopic lung volume reduction', 'BLVR', 'standard of care (SoC', 'Static hyperinflation']","['Dynamic Hyperinflation', 'inspiratory capacity (IC', 'residual volume', 'dynamic hyperinflation', 'Static and dynamic hyperinflation measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3697654', 'cui_str': 'Bronchoscopic lung volume reduction'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",18.0,0.0337627,"An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'van Dijk', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands. m.van.dijk05@umcg.nl.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Klooster', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jorine E', 'Initials': 'JE', 'LastName': 'Hartman', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nick H T', 'Initials': 'NHT', 'LastName': 'Ten Hacken', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}]",Lung,['10.1007/s00408-020-00382-x']
2337,32706635,Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma.,"PURPOSE


To evaluate the efficacy and safety of pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG) in patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA).
PATIENTS AND METHODS


HALO 109-301 was a phase III, randomized, double-blind, placebo-controlled study. Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA were randomly assigned 2:1 to PEGPH20 plus AG or placebo plus AG. Treatment was administered intravenously in 4-week cycles (3 weeks on, 1 week off) until progression or intolerable adverse events: PEGPH20 3.0 µg/kg twice per week for cycle 1 and once per week thereafter; nab-paclitaxel 125 mg/m 2  once per week; and gemcitabine 1,000 mg/m 2  once per week. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Response was independently assessed per RECIST v1.1.
RESULTS


At data cutoff, 494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for placebo) included in intention-to-treat analyses. Baseline characteristics were balanced for PEGPH20 plus AG versus placebo plus AG. There were 330 deaths, with a median OS of 11.2 months for PEGPH20 plus AG versus 11.5 months for placebo plus AG (hazard ratio [HR], 1.00; 95% CI, 0.80 to 1.27;  P  = .97); median PFS was 7.1 months versus 7.1 months (HR, 0.97 [95% CI, 0.75 to 1.26]); ORR was 47% versus 36% (ORR ratio, 1.29 [95% CI, 1.03 to 1.63]). Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
CONCLUSION


The addition of PEGPH20 to AG increased the ORR but did not improve OS or PFS. The safety profile of PEGPH20 plus AG was consistent with that found in previous studies. These results do not support additional development of PEGPH20 in metastatic PDA.",2020,"Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
","['HALO 109-301 was a phase III', 'Patients', 'Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA', 'patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA', '494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for']","['pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG', 'Pegvorhyaluronidase Alfa', 'PEGPH20 plus AG or placebo plus AG', 'PEGPH20 plus AG', 'gemcitabine', 'Nab-Paclitaxel Plus Gemcitabine', 'placebo']","['overall survival (OS); secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety', 'fatigue', 'ORR', 'efficacy and safety', 'Grade ≥ 3 adverse events', 'hyponatremia', 'muscle spasms', 'median PFS']","[{'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2826358', 'cui_str': 'PEGPH20'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2826358', 'cui_str': 'PEGPH20'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",494.0,0.605717,"Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, UCSF Medical Center, San Francisco, CA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Sigal', 'Affiliation': 'Division of Hematology/Oncology, Scripps Clinic and Scripps MD Anderson Cancer Center, La Jolla, CA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': 'Division of Gastrointestinal Medical Oncology & Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hitre', 'Affiliation': 'Department of Medical Oncology and Clinical Pharmacology ""B,"" National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon (AP-HP), Clichy, and Université de Paris, Paris, France.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Hendifar', 'Affiliation': 'Department of Gastrointestinal Malignancies, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Bates', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Chung-Pin', 'Initials': 'CP', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sunil R', 'Initials': 'SR', 'LastName': 'Hingorani', 'Affiliation': 'Fred Hutchinson Cancer Research Center and Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Kasi', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Maraveyas', 'Affiliation': 'Joint Centre for Cancer Studies, Hull York Medical School, Castle Hill Hospital, Cottingham, United Kingdom.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Layos', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology (ICO), Hospital Germans Trias i Pujol, Badalona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Lacy', 'Affiliation': 'Department of Medicine, Section of Medical Oncology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Institut du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oberstein', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, CA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Chondros', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, CA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00590']
2338,32701928,"Volume and effectiveness assessment of articain 4% versus mepivacaine 2% used in third molar surgery: randomized, double-blind, split-mouth controlled clinical trial.","BACKGROUND


The different indications for extraction of the lower third molars, require resources to manage pain and discomfort, such as, for example, adequate anesthetic techniques, and the type of anesthetic used can influence the management of pain in tooth extractions. Few studies in the literature compare the anesthetics 4% articaine hydrochloride and 2% mepivacaine hydrochloride showing evidence that both allow for successful pain management. This study sought to compare the volume, efficacy and safety of these two anesthetic drugs, both associated with epinephrine at a ratio of 1:100,000, used in the extraction of lower third molars.
MATERIAL AND METHODS


A controlled, clinical, split-mouth compared these both local anesthetics in a sample of 20 patients requiring bilateral extraction of teeth. Pain was the main parameter to be assessed by means of the visual analogue scale (VAS) applied during and immediately after the surgery. Hemodynamic parameters, adverse events, presence of paresthesia and satisfaction of patients and surgeon were also analysed.
RESULTS


Pain management was more effective with mepivacaine up to two hours after surgery (p=0.014), whereas the surgeon was more satisfied with the use of articaine during divulsion and suture (p<0.05). However no statistically significant differences were found between both anesthetics regarding pain perception.
CONCLUSIONS


It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed. The satisfaction of patients and surgeon was the same for both anesthetics, with articaine being highlighted during divulsion and suture.",2020,"It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed.",['20 patients requiring bilateral extraction of teeth'],"['mepivacaine hydrochloride', 'local anesthetics', 'articaine', 'articaine hydrochloride', 'epinephrine', 'mepivacaine']","['visual analogue scale (VAS', 'Pain', 'Hemodynamic parameters, adverse events, presence of paresthesia and satisfaction of patients and surgeon', 'volume, efficacy and safety', 'pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0700542', 'cui_str': 'Mepivacaine hydrochloride'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",20.0,0.145288,"It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed.","[{'ForeName': 'P-C', 'Initials': 'PC', 'LastName': 'Almeida', 'Affiliation': 'Cale Francisco José Longo Avenue, 777 Jardim São Dimas, São José dos Campos SP, Brazil, 12245 -000 paulacarolinasj@yahoo.com.br.'}, {'ForeName': 'F-V', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': ''}, {'ForeName': 'F-R', 'Initials': 'FR', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'R-D', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'M-B', 'Initials': 'MB', 'LastName': 'Moraes', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23780']
2339,32701929,Leukocyte- and platelet-rich fibrin does not provide any additional benefit for tooth extraction in head and neck cancer patients post-radiotherapy: a randomized clinical trial.,"BACKGROUND


One of the most important complications of radiotherapy (RT) for head and neck cancer (HNC) is osteoradionecrosis (ORN) of the jaws, arising mainly from tooth extractions. Thus, the present study aimed to evaluate the efficacy of leukocyte- and platelet-rich fibrin (L-PRF) in preventing ORN following tooth extraction in post-irradiated HNC patients, as well as other postoperative complications.
MATERIAL AND METHODS


23 patients previously submitted to conventionally fractionated 3D-conformational RT for HNC underwent atraumatic tooth extractions with perioperative antibiotic therapy. Besides, they were randomly assigned to receive L-PRF clots to fill and cover the extraction sockets (n=11, Test Group) or not (n=12, Control Group). A visual analog scale was used to quantify postoperative pain on the 3rd and 7th days. For ORN diagnosis, patients were clinically assessed for up to 180 days. Other postoperative complications (edema, alveolitis, suture dehiscence, continuous bleeding, and oroantral communication) were also evaluated within this period.
RESULTS


No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
CONCLUSIONS


L-PRF did not seem to provide any additional benefits than those achieved by the combination of the surgical and drug protocols used for tooth extractions in the post-irradiated HNC patients.",2020,"No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
","['head and neck cancer patients post', '23 patients previously submitted to conventionally fractionated 3D-conformational RT for HNC underwent atraumatic tooth extractions with perioperative antibiotic therapy']","['radiotherapy', 'radiotherapy (RT', 'leukocyte- and platelet-rich fibrin (L-PRF', 'L-PRF clots to fill and cover the extraction sockets', 'Leukocyte- and platelet-rich fibrin']","['ORN or another surgical complication', 'postoperative complications (edema, alveolitis, suture dehiscence, continuous bleeding, and oroantral communication', 'postoperative pain scores']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]","[{'cui': 'C0029461', 'cui_str': 'Osteoradionecrosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0549493', 'cui_str': 'Alveolitis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0029293', 'cui_str': 'Oroantral fistula'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.0349457,"No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
","[{'ForeName': 'L-F', 'Initials': 'LF', 'LastName': 'Palma', 'Affiliation': 'Rua da Moóca, 2518 cj13. 03104-002 São Paulo, SP, Brazil leandro_chambrone@hotmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcucci', 'Affiliation': ''}, {'ForeName': 'C-M', 'Initials': 'CM', 'LastName': 'Remondes', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Chambrone', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23804']
2340,32715482,"Effect of novel short-arm human centrifugation-induced gravitational gradients upon cardiovascular responses, cerebral perfusion and g-tolerance.","KEY POINTS


The aim of this study was to determine the effect of rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC) upon cardiovascular responses, cerebral perfusion and g-tolerance. In 10 male and 10 female participants, 10 min passive SAHC runs were performed with the RAP above the head (P1), at the apex of the head (P2), or at heart level (P3), with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. We hypothesized that movement of the RAP from above the head (the conventional position) towards the heart might reduce central hypovolaemia, limit cardiovascular responses, aid cerebral perfusion, and thus promote g-tolerance. Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance. Our results also suggest that RAP, and thus g-gradient, warrants further investigation as it may support use as a holistic spaceflight countermeasure.
ABSTRACT


Artificial gravity (AG) through short-arm human centrifugation (SAHC) has been proposed as a holistic spaceflight countermeasure. Movement of the rotational axis position (RAP) from above the head towards the heart may reduce central hypovolaemia, aid cerebral perfusion, and thus promote g-tolerance. This study determined the effect of RAP upon cardiovascular responses, peripheral blood displacement (i.e. central hypovolaemia), cerebral perfusion and g-tolerance, and their inter-relationships. Twenty (10 male) healthy participants (26.2 ± 4.0 years) underwent nine (following a familiarization run) randomized 10 min passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart level (P3) with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolaemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP) were continuously recorded, in addition to incidence of pre-syncopal symptoms (PSS). ΔCC and ΔHR increases were attenuated from P1 to P3 (ΔCC: 5.46 ± 0.54 mm to 2.23 ± 0.42 mm; ΔHR: 50 ± 4 bpm to 8 ± 2 bpm, P < 0.05). In addition, ΔcTSI decrements were also attenuated (ΔcTSI: -2.85 ± 0.48% to -0.95 ± 0.34%, P < 0.05) and PSS incidence lower in P3 than P1 (P < 0.05). A positive linear relationship was observed between ΔCC and ΔHR with increasing +Gz, and a negative relationship between ΔCC and ΔcTSI, both independent of RAP. Our data suggest that movement of RAP towards the heart (reduced g-gradient), independent of foot-level Gz, leads to improved g-tolerance. Further investigations are required to assess the effect of differential baroreceptor feedback (i.e. aortic-carotid g-gradient).",2020,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","['10 male and 10 female participants, 10-min passive SAHC runs were performed with the RAP above (P1), or at the apex of the head (P2), or at heart-level (P3), with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'Twenty (10 male) healthy participants (26.2\xa0±\xa04.0\xa0yr) underwent nine (following a familiarisation run) randomised']","['novel short-arm human centrifugation induced gravitational gradients', 'rotational axis position (RAP', 'short-arm human centrifugation (SAHC', 'RAP', '10-minute passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart-level (P3) with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC']","['incidence of pre-syncopal symptoms (PSS', 'ΔcTSI decrements', 'cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance', 'ΔCC and ΔHR increases', 'cardiovascular responses, peripheral blood displacement (i.e. central hypovolemia), cerebral perfusion and g-tolerance, and their inter-relationships', 'cardiovascular responses, cerebral perfusion and g-tolerance', 'PSS incidence', 'Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",10.0,0.0415868,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Laing', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': ""King's College London, Centre for Human and Applied Physiological Sciences (CHAPS), London, UK.""}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Mulder', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hinghofer-Szalkay', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Blaber', 'Affiliation': 'Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rittweger', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Nandu', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}]",The Journal of physiology,['10.1113/JP273615']
2341,32711435,"The Outcome of a Self-Efficacy Enhancement Program for Cervical Cancer Screening among Women in Phrasaeng District, Suratthani Province, Thailand.","OBJECTIVE


The purpose of this research was to examine the effect of a self-efficacy enhancement program on perceived self-efficacy and cervical cancer screening among women.
METHODS


This research was quasi-experimental research, using the subjects consisted of 130 samples; each of the experimental and control group consisted of 65 samples. The experimental group received a self-efficacy enhancement program. The control group received knowledge and usual care by health personnel in the health promoting hospital. The duration of the research was 8 weeks. The self-efficacy was testing the reliability equal to 0.90. Data were analyzed using descriptive statistics, Chi-square, and t-test.
RESULTS


The mean scores of perceived self-efficacy between the experimental and control group before using the program (M=2.18, S.D.=0.40; M=2.22, S.D.=0.39), there was no significantly different (p> 0.05). The mean scores of perceived self-efficacy between the experimental and control group after using the program (M=4.11, S.D.=0.44; M=2.28, S.D.=0.42), there was a significantly different (p< 0.001). The mean scores of perceived self-efficacy of the experimental group before and after using the program were higher, (M=2.18, S.D.=0.40; M=4.11, S.D.=0.44), there was a significantly different (p< 0.001). The experimental group came to screening 64 people (98.5 %), and the control group came to screening eight people (12.3 %), calculated ratio as 8:1 and compared the cervical cancer screening in the experimental and control group had differences significantly (p< 0.001).
CONCLUSION


The self-efficacy enhancement program, resulting in increased screening rates and screened after the first week by having most screening tests in the community. Therefore, the program should be applied, and proactive services should be provided for women to have access in community and a health service place.<br />.",2020,"The mean scores of perceived self-efficacy of the experimental group before and after using the program were higher, (M=2.18, S.D.=0.40; M=4.11, S.D.=0.44), there was a significantly different (p< 0.001).","['Cervical Cancer Screening among Women in Phrasaeng District, Suratthani Province, Thailand', 'women']","['knowledge and usual care by health personnel in the health promoting hospital', 'self-efficacy enhancement program']","['cervical cancer screening', 'mean scores of perceived self-efficacy', 'self-efficacy and cervical cancer screening']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4075891', 'cui_str': 'Enhancement of self-efficacy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0170426,"The mean scores of perceived self-efficacy of the experimental group before and after using the program were higher, (M=2.18, S.D.=0.40; M=4.11, S.D.=0.44), there was a significantly different (p< 0.001).","[{'ForeName': 'Ornuma', 'Initials': 'O', 'LastName': 'Bunkarn', 'Affiliation': 'School of Nursing, Walailak University, Thasala, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Kiatkamjorn', 'Initials': 'K', 'LastName': 'Kusol', 'Affiliation': 'School of Nursing, Walailak University, Thasala, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Eksirinimit', 'Affiliation': 'School of Nursing, Walailak University, Thasala, Nakhon Si Thammarat, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.7.2075']
2342,32711440,Efficacy Oral Glutamine to Prevent Oral Mucositis and Reduce Hospital Costs During Chemotherapy in Children with Acute Lymphoblastic Leukemia.,"OBJECTIVE


To investigate the use of glutamine administered orally during Methotrexate chemotherapy to prevent oral mucositis and reduce hospital costs in children with acute lymphoblastic leukemia (ALL).
METHODS


Twenty-four children received oral glutamine (400 mg/kg body weight per day) and twenty four received placebo on days of chemotherapy administration and for at least 14 additional days. Oral mucositis  was graded daily at each day of treatment till completion of therapy. The study groups were compared for the oral mucositis development using the WHO scale.
RESULTS


Oral mucositis occurred in 4.2 % of the glutamine group and 62.5% in the placebo group. The use of glutamine was directly associated with prevention of oral mucositis than placebo (OR 0,026; 95% CI: 0,003-0,228). The duration of length hospital stay was lower in the glutamine group than in the placebo group ((8 vs 12 days); p = 0,005). Hospital cost per day for glutamine group was 40 USD per day while placebo group was 48 USD per day.
CONCLUSIONS


There was significant difference in the prevention of oral mucositis by oral glutamine vs placebo. The hospital cost for glutamine supplementation was lower than control group.",2020,"The use of glutamine was directly associated with prevention of oral mucositis than placebo (OR 0,026; 95% CI: 0,003-0,228).","['Children with Acute Lymphoblastic Leukemia', 'Twenty-four children received', 'children with acute lymphoblastic leukemia (ALL']","['oral glutamine', 'Glutamine', 'glutamine', 'Methotrexate chemotherapy', 'placebo']","['prevention of oral mucositis', 'Oral mucositis', 'Oral Mucositis and Reduce Hospital Costs', 'hospital cost for glutamine supplementation', 'oral mucositis and reduce hospital costs', 'duration of length hospital stay', 'oral mucositis', 'Hospital cost']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",24.0,0.099924,"The use of glutamine was directly associated with prevention of oral mucositis than placebo (OR 0,026; 95% CI: 0,003-0,228).","[{'ForeName': 'Nur Aisiyah', 'Initials': 'NA', 'LastName': 'Widjaja', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Ardha', 'Initials': 'A', 'LastName': 'Pratama', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Rendi', 'Initials': 'R', 'LastName': 'Prihaningtyas', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Roedi', 'Initials': 'R', 'LastName': 'Irawan', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Idg', 'Initials': 'I', 'LastName': 'Ugrasena', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.7.2117']
2343,32712034,Pragmatic Randomized Controlled Pilot Trial on Trigger Point Injections With 1% Lidocaine Versus Conventional Approaches for Myofascial Pain in the Emergency Department.,"BACKGROUND


Myofascial neck and back pain is an increasingly common chief symptom in the emergency department. Currently, there are no widely accepted conventional therapies, and there is little evidence on the efficacy of interventions such as trigger point injections (TPIs).
OBJECTIVE


This study evaluates whether TPIs with 1% lidocaine can improve myofascial back and neck pain compared with conventional therapies. Secondary outcomes include changes in length of stay and number of opioid prescriptions on discharge.
METHODS


This single-center, prospective, randomized, pragmatic trial was carried out in patients clinically determined to have myofascial back or neck pain. Patients were randomized into the experimental arm (TPI with 1% lidocaine) or the control arm (standard conventional approach). Numeric Rating Scores (NRS) for pain and additional surveys were obtained prior to and 20 min after the intervention.
RESULTS


The NRS for pain was lower in the TPI group compared with the control group after adjustment for initial pain (median difference -3.01; 95% confidence interval -4.20 to -1.83; p < 0.001). Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001). More patients in the control group (47.4%) were discharged home with an opioid compared with the TPI group (2.9%) (p < 0.001).
CONCLUSIONS


TPI is an effective method for managing myofascial pain in the emergency department. This study indicates it may improve pain compared with conventional methods, reduce length of stay in the emergency department, and reduce opioid prescriptions on discharge.",2020,Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001).,['patients clinically determined to have myofascial back or neck pain'],"['Lidocaine', 'TPIs with 1% lidocaine', 'lidocaine']","['changes in length of stay and number of opioid prescriptions on discharge', 'Numeric Rating Scores (NRS) for pain and additional surveys', 'myofascial pain', 'myofascial back and neck pain', 'NRS for pain', 'pain', 'Myofascial Pain', 'Median length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.172924,Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001).,"[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Yanuck', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California; Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Saadat', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Jen', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Chakravarthy', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.015']
2344,32711414,Incremental Benefits of Multiple Tobacco Control Interventions: A Factorial Randomized Control Trial.,"Tobacco control requires a comprehensive approach. The present study aims to examine the incremental effectiveness of health systems intervention when combined with other interventions in enhancing knowledge and practices of physicians in tobacco cessation.
METHODS


A randomized control trial was conducted among 437 physicians in 12 districts of two states of India in 2011-13. The interventions consisted of Health Systems (H), Community (C) and Youth intervention (Y). Administrative Blocks /Mandals were randomly assigned to one of the three interventions (HC /HCY/HY) and control units. The health system intervention consisted of training physicians and developing a system of patient support and supervision for tobacco cessation. The primary outcome was change in knowledge and practices of physicians in tobacco cessation. Logistic regression model was applied to assess the impact of single and combination of interventions.
RESULTS


An increase in knowledge was observed on effects of tobacco on adverse birth outcomes, advice on NRT and, information provided on chronic disease management among physicians in HC, HY and HCY intervention units compared to control units from pre-intervention to post-intervention. Statistically significant change was observed in knowledge of physicians on effects of tobacco on adverse birth outcomes in HC (OR- 4.75, p-0.02) and HCY (OR- 5.08, p-0.04) intervention units.
CONCLUSIONS


HCY intervention was most effective in enhancing knowledge and practices of physicians in tobacco cessation. Our study suggests that individual tobacco control interventions when combined together has an incremental effect and increases the likelihood of provision of tobacco cessation services in primary care. <br />.",2020,"An increase in knowledge was observed on effects of tobacco on adverse birth outcomes, advice on NRT and, information provided on chronic disease management among physicians in HC, HY and HCY intervention units compared to control units from pre-intervention to post-intervention.","['437 physicians in 12 districts of two states of India in 2011-13', 'Administrative Blocks /Mandals']","['Health Systems (H), Community (C) and Youth intervention (Y', 'health systems intervention', 'HCY intervention', 'Multiple Tobacco Control Interventions']","['change in knowledge and practices of physicians in tobacco cessation', 'adverse birth outcomes']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}]",,0.0620255,"An increase in knowledge was observed on effects of tobacco on adverse birth outcomes, advice on NRT and, information provided on chronic disease management among physicians in HC, HY and HCY intervention units compared to control units from pre-intervention to post-intervention.","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Persai', 'Affiliation': 'Indian Institute of Public Health, Public Health Foundation of India, Delhi NCR, India.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Karan', 'Affiliation': 'Indian Institute of Public Health, Public Health Foundation of India, Delhi NCR, India.'}, {'ForeName': 'Rajmohan', 'Initials': 'R', 'LastName': 'Panda', 'Affiliation': 'Indian Institute of Public Health, Public Health Foundation of India, Delhi NCR, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.7.1905']
2345,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025']
2346,32717123,Improvement in histological endpoints of MAFLD following a 12-week aerobic exercise intervention.,"BACKGROUND


Lifestyle interventions are the primary treatment for metabolic (dysfunction) associated fatty liver disease (MAFLD). However, the histological and cardiometabolic effects of aerobic exercise in MAFLD remain unclear.
AIMS


To assess the effects of a 12-week aerobic exercise intervention on histological and cardiometabolic endpoints in MAFLD.
METHODS


Patients with biopsy-confirmed MAFLD participated in a 12-week aerobic exercise intervention. Liver histology, cardiorespiratory fitness (estimated V̇O 2max  ), physical activity, anthropometry and biochemical markers were assessed at baseline, intervention completion, and 12 and 52 weeks after intervention completion.
RESULTS


Twenty-four patients completed the exercise intervention (exercise group n = 16, control group n = 8). In the exercise group, 12 weeks of aerobic exercise reduced fibrosis and hepatocyte ballooning by one stage in 58% (P = 0.034) and 67% (P = 0.020) of patients, with no changes in steatosis (P = 1.000), lobular inflammation (P = 0.739) or NAFLD activity score (P = 0.172). Estimated V̇O 2max  increased by 17% compared to the control group (P = 0.027) but this level of improvement was not maintained at 12 or 52 weeks after the intervention. Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively. Anthropometric reductions including body mass (P = 0.038), waist circumference (P = 0.015) and fat mass (P = 0.007) were also observed, but no patient achieved 7%-10% weight loss.
CONCLUSION


This study highlights the potential benefits of a 12-week aerobic exercise intervention in improving histological endpoints of MAFLD. The development of strategies to ensure continued engagement in aerobic exercise in MAFLD are needed.",2020,"Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively.",['Patients with biopsy-confirmed MAFLD participated in a 12-week'],"['aerobic exercise intervention', 'exercise intervention (exercise', 'aerobic exercise']","['waist circumference', 'steatosis', 'fibrosis and hepatocyte ballooning', 'Liver histology, cardiorespiratory fitness (estimated V̇O 2max  ), physical activity, anthropometry and biochemical markers', 'Anthropometric reductions including body mass', 'fat mass', 'Estimated V̇O 2max', 'lobular inflammation', 'NAFLD activity score', 'estimated V̇O 2max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0227525', 'cui_str': 'Hepatic parenchymal cell'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0431615,"Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': ""O'Gorman"", 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Naimimohasses', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Monaghan', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Ashanty M', 'Initials': 'AM', 'LastName': 'Melo', 'Affiliation': 'Department of Immunology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Ní Fhloinn', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Doherty', 'Affiliation': 'Department of Immunology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beddy', 'Affiliation': ""Department of Radiology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Finn', 'Affiliation': ""Department of Histopathology, St James's Hospital and Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'J Bernadette', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'School of Food Science and Nutrition, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gormley', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15989']
2347,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
2348,32717294,A Novel Link between the Oxytocin Receptor Gene and Impulsivity.,"Impulsivity includes hasty actions, social intrusiveness or premature decision-making. Neuropeptides like oxytocin alleviate haste and anxiety, and affect fear conditioning. However, no investigations have been done via gene-network based approach with cognitive and interventional genetic association studies to scrutinize the link between impulsive behavior and oxytocin. Here, interactive gene network and pathways associated with impulsivity were reconstructed, and serotonin transporter gene (SLC6A4) and serotoninergic synaptic transmission were identified as the most central gene and pathway related to impulsivity. Young healthy males received intranasal oxytocin or placebo, and impulsivity was evaluated via go/no-go test. Test performance scores then were analyzed based on commission and omission errors, response inhibition and reaction time. Blood DNA was extracted and a 761 bp intronic region in oxytocin receptor (OXTR) gene was amplified and sequenced using PCR-pyrosequencing. Employing Haploview, haplotypes and linkage disequilibrium (LD) pattern among all SNPs in the target sequence were determined based on D' and LOD values, and rs2254298 with the highest LD was indicated as the tag SNP. Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition. This means that oxytocin alleviated impulsive behavior, and subjects with GG genotype had lower rate of impulsivity than those with GA and AA genotypes. rs2254298 may modulate the function or expression of the OXTR gene, implying that G allele may increase the expression of OXTR gene compared to A allele. We suggest that intranasal oxytocin may notably moderate impulsive behavior and tendency to make hasty or premature decisions.",2020,Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition.,['Young healthy males'],"['Oxytocin', 'oxytocin', 'intranasal oxytocin or placebo', 'intranasal oxytocin']","['commission and omission errors, response inhibition and reaction time', 'Impulsivity includes hasty actions, social intrusiveness or premature decision-making', 'Blood DNA', 'rate of impulsivity', 'commission error and increased inhibition']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.034954,Oxytocin group and participants with GG genotype showed a significantly decreased commission error and increased inhibition.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bozorgmehr', 'Affiliation': 'Iran Psychiatric Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: bozorgmehr.a@iums.ac.ir.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Moayedi', 'Affiliation': 'Department of Mathematics, Payam Noor University of Tehran, Tehran, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Biochemistry, Institute of Biochemistry and Biophysics (IBB), University of Tehran, Tehran, Iran. Electronic address: bahman.sadeghi@ut.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghadirivasfi', 'Affiliation': 'Research Center for Addiction and Risky Behavior (ReCARB), Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: gadirivasfi.m@iums.ac.ir.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Joghataei', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shahbazi', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran; Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: shahbazi.a@iums.ac.ir.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.033']
2349,32719263,Comparison of extraoral and intraoral routes of glossopharyngeal nerve block for pain relief in patient with carcinoma tongue: A prospective randomized study.,"Background and Objective


Glossopharyngeal nerve block (GNB) technique has been used as alternative of treatment of cancer and noncancer pain of the oral cavity. The objective of the study is to compare the two approaches (extraoral and intraoral) of GNB in patients of carcinoma of the tongue in terms of efficacy, duration, and complications.
Materials and Methods


This was a prospective comparative randomized study over a period of 1 year. Fifty patients of either sex of ASA physical status and 2, between 21 and 70 years of age, suffering from carcinoma of the tongue, were selected. The patients were randomly divided into two groups. Group I received 4 mL of 0.5% bupivacaine combined with 40 mg, of triamcinolonacetonide by extraoral approach of GNB, and Group II received the same amount of drug by intraoral approach of GNB. Hemodynamic parameters, degree of pain relief using visual analog scale (VAS), number of attempts, effect on quality of life (QOL), and complication were noted during the performance of GNB.
Results


Demographic profile in both groups was comparable. Rate of complication and number of attempts to complete intervention were higher in Group I, which was found to be statistically significant. However, mean VAS scores in Group I were significantly higher as compared to those in Group II during most of the study period starting from the 1 st  follow-up at 30 min to the 2 nd  month postintervention (P < 0.05). No statistically significant difference in mean QOL scores of two groups was observed for the entire study period except at 1 week when mean scores in Group I were higher as compared to those in Group II (P = 0.011).
Conclusion


The intraoral approach of GNB was better with respect to pain control and improvement in QOL whereas the rate of complication and number of attempts was lower in extraoral approach of GNB.",2020,"Rate of complication and number of attempts to complete intervention were higher in Group I, which was found to be statistically significant.","['patient with carcinoma tongue', 'Fifty patients of either sex of ASA physical status and 2, between 21 and 70 years of age, suffering from carcinoma of the tongue, were selected', 'patients of carcinoma of the tongue in terms of']","['extraoral and intraoral routes of glossopharyngeal nerve block', 'GNB', '4 mL of 0.5% bupivacaine combined with 40 mg, of triamcinolonacetonide by extraoral approach of GNB', 'Glossopharyngeal nerve block (GNB) technique']","['pain relief', 'Hemodynamic parameters, degree of pain relief using visual analog scale (VAS), number of attempts, effect on quality of life (QOL), and complication', 'QOL', 'mean VAS scores', 'efficacy, duration, and complications', 'mean QOL scores', 'Rate of complication and number of attempts to complete intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558353', 'cui_str': 'Tongue carcinoma'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0442089', 'cui_str': 'Extraoral approach'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0394814', 'cui_str': 'Local anesthetic glossopharyngeal nerve block'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.032264,"Rate of complication and number of attempts to complete intervention were higher in Group I, which was found to be statistically significant.","[{'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Neel Kamal', 'Initials': 'NK', 'LastName': 'Mishra', 'Affiliation': 'Department of Anaesthesiology, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Anaesthesiology, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Department of Anaesthesiology, King George Medical University, Lucknow, Uttar Pradesh, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_309_18']
2350,32717295,Effects of Nicotine on Task Switching and Distraction in Non-smokers. An fMRI Study.,"Nicotine improves sustained attention and reduces distractor interference, promoting cognitive stability. While stable performance may be beneficial in some situations, others require flexible updating of task demands. Frontoparietal networks, basal ganglia and thalamus contribute to an optimal balance of stable and flexible performance. We aimed to test how the cholinergic agonist nicotine modulates this balance and used an ongoing visual task including switch and distractor trials to gauge cognitive flexibility and stability respectively. Young healthy non-smokers (n = 39) received either a 7 mg transdermal nicotine or placebo patch in a double-blind, within-subject design one hour prior to performing the task in a 3 T MR scanner. Nicotine enhanced response times in all task conditions but did not significantly impact distractor or switch costs. Neurally, there was no significant nicotine induced modulation of distractor- or switch-related activity on group level. However, a brain-behaviour correlation analysis revealed that the nicotine-induced alterations of distractor costs correlated positively with distractor-related neural activity in the right intraparietal sulcus and the right pulvinar nucleus of the thalamus. We suggest that a nicotinic contribution to balancing stability and flexibility is weak in young healthy non-smokers. The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.",2020,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","['young healthy non-smokers', 'non-smokers', 'Young healthy non-smokers (n=39']","['Nicotine', 'cholinergic agonist nicotine', 'transdermal nicotine or placebo patch', 'nicotine']","['task switching and distraction', 'distractor costs', 'distractor interference', 'sustained attention and reduces distractor interference, promoting cognitive stability', 'impact distractor or switch costs']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0242894', 'cui_str': 'Cholinergic Agonist'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0408686,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ahrens', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Cluster of Excellence ""Hearing4all"", Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Research Center Neurosensory Science, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany. Electronic address: christiane.thiel@uni-oldenburg.de.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.029']
2351,32719487,Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin.,"We asked whether pharmacological stimulation of endogenous neural precursor cells (NPCs) may promote cognitive recovery and brain repair, focusing on the drug metformin, in parallel rodent and human studies of radiation injury. In the rodent cranial radiation model, we found that metformin enhanced the recovery of NPCs in the dentate gyrus, with sex-dependent effects on neurogenesis and cognition. A pilot double-blind, placebo-controlled crossover trial was conducted (ClinicalTrials.gov, NCT02040376) in survivors of pediatric brain tumors who had been treated with cranial radiation. Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus were evaluated as endpoints. Twenty-four participants consented and were randomly assigned to complete 12-week cycles of metformin (A) and placebo (B) in either an AB or BA sequence with a 10-week washout period at crossover. Blood draws were conducted to monitor safety. Feasibility was assessed as recruitment rate, medication adherence and procedural adherence. Linear mixed modeling was used to examine cognitive and MRI outcomes as a function of cycle, sequence and treatment. We found no clinically relevant safety concerns and no serious adverse events associated with metformin. Sequence effects were observed for all cognitive outcomes in our linear mixed models. For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory. We present evidence that a clinical trial examining the effects of metformin on cognition and brain structure is feasible in long-term survivors of pediatric brain tumors and that metformin is safe to use and tolerable in this population. This pilot trial was not intended to test the efficacy of metformin for cognitive recovery and brain growth, but the preliminary results are encouraging and warrant further investigation in a large multicenter phase 3 trial.",2020,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","['Twenty-four participants consented', 'survivors of pediatric brain tumors', 'survivors of pediatric brain tumors who had been treated with cranial radiation']","['metformin (A) and placebo (B', 'pharmacological stimulation of endogenous neural precursor cells (NPCs', 'metformin', 'placebo']","['Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus', 'declarative and working memory', 'recruitment rate, medication adherence and procedural adherence', 'recovery of NPCs']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441694', 'cui_str': 'Pharmacological stimulation'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]",24.0,0.0743775,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","[{'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Ayoub', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Ruddy', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Adeoye', 'Initials': 'A', 'LastName': 'Oyefiade', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Derkach', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ades-Aron', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shirzadi', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Fieremans', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jovanka', 'Initials': 'J', 'LastName': 'Skocic', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Division of Haematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Freda D', 'Initials': 'FD', 'LastName': 'Miller', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cindi M', 'Initials': 'CM', 'LastName': 'Morshead', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada. cindi.morshead@utoronto.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada. donald.mabbott@sickkids.ca.'}]",Nature medicine,['10.1038/s41591-020-0985-2']
2352,32717684,"Switching to fingolimod in PREFERMS: Effect of treatment history and naïvety on clinical, MRI and treatment satisfaction outcomes ✰ .","BACKGROUND


Injectable disease-modifying therapies (iDMTs) are often used as first-line treatments for relapsing multiple sclerosis. Fingolimod is frequently used following treatment with iDMTs. Whether prior iDMT treatment impacts the effectiveness of subsequent fingolimod therapy is unclear. Here, we assessed switching from iDMTs to fingolimod, and the impact of treatment history on fingolimod escalation using data from the 12-month 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease-modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS). The study design and results at the end of randomized treatment (EoRT) in PREFERMS have been published.
METHODS


Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study. Pre-specified exploratory analyses compared outcomes in those randomized to fingolimod or to an iDMT at end of study (EoS), which included time spent on randomized and on switch treatment. Post hoc exploratory analyses (unadjusted for multiplicity owing to the large number of comparisons) among patients randomized to an iDMT who switched to fingolimod, compared outcomes longitudinally before (EoRT) and after (EoS) switching, and compared outcomes at EoRT and EoS among subgroups stratified by iDMT-treatment history. Outcomes included brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates.
RESULTS


At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to fingolimod had switched to an iDMT. By EoS, 44.2% of total treatment exposure in the iDMT group was to fingolimod and the mean time spent on fingolimod in this group was 220 days (approximately 7 months). Outcomes in the fingolimod group at EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score) were similar to those seen at EoRT, but in the iDMT group these outcomes were more favorable at EoS than at EoRT and were similar to rates seen in the fingolimod group. Among patients who switched from iDMT to fingolimod, there were longitudinal improvements in ARR (EoRT, 0.3 [95% confidence interval (CI), 0.2-0.4]; EoS, 0.2 [0.1-0.3]; odds ratio, 0.5 [0.3-0.9]) and in treatment satisfaction (proportion of patients with MSQ > 5; EoRT, 67.4%; EoS, 90.4%; odds ratio, 5.7 [95% CI, 3.4-9.4]) after fingolimod treatment, and changes in brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation were also more favorable at EoS than at EoRT. In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
CONCLUSION


These analyses indicate that patients in PREFERMS had improved outcomes within months of switching to fingolimod from an iDMT and that improvements occurred irrespective of the number of iDMTs previously administered. These data provide a unique opportunity to explore clinical, radiological and safety outcomes associated with a range of clinically relevant treatment pathways.",2020,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","['At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to', 'Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study', ""adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS""]","['fingolimod had switched to an iDMT', 'Fingolimod versus approved first-line disease-modifying thErapies']","['EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score', 'mean time spent on fingolimod', 'brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates', 'longitudinal improvements in ARR', 'brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation']","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",439.0,0.0609136,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd. Suite 103, Franklin, TN 37064, United States. Electronic address: sfhunter@neurosci.us.'}, {'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Thomas', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, South Orange, and Hackensack University Medical Center, Hackensack, NJ, United States. Electronic address: florian.thomas@hackensackmeridian.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cascione', 'Affiliation': 'Tampa Neurology Associates, Tampa, FL, United States. Electronic address: me@markcascione.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'Oxford PharmaGenesis, Oxford, United Kingdom. Electronic address: ian.williams@pharmagenesis.com.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: xiangyi.meng@novartis.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: lesley.schofield@novartis.com.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: jamie.weiss@novartis.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: nadia.tenebaum@novartis.com.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102346']
2353,32718555,Incidence and Prognostic Impact of Incomplete Revascularization Documented by Coronary Angiography 1 Year After Coronary Artery Bypass Grafting.,"Complete revascularization (CR) at the time of coronary artery bypass graft (CABG) surgery improves long-term cardiac outcomes. No studies have previously reported angiographically confirmed CR rates post-CABG. This study's aim was to assess the impact upon long-term outcomes of CR versus incomplete revascularization (IR), confirmed by coronary angiography 1 year after CABG. Randomized On/Off Bypass Study patients who returned for protocol-specified 1-year post-CABG coronary angiograms were included. Patients with a widely patent graft supplying the major diseased artery within each diseased coronary territory were considered to have CR. Outcomes were all-cause mortality and major adverse cardiovascular events (MACE; all-cause mortality, nonfatal myocardial infarction, repeat revascularization) over the 4 years after angiography. Of the 1,276 patients, 756 (59%) had CR and 520 (41%) had IR. MACE was 13% CR versus 26% IR, p <0.001. This difference was driven by fewer repeat revascularizations (5% CR vs 18% IR; p <0.001). There were no differences in mortality (7.1% CR vs 8.1% IR, p = 0.13) or myocardial infarction (4% in both). Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p <0.01), but had no impact on mortality. In conclusion, CR confirmed by post-CABG angiography was associated with improved MACE but not mortality. Repeat revascularization of patients with IR, driven by knowledge of the research angiography results, may have ameliorated potential mortality differences.",2020,"Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p <0.01), but had no impact on mortality.","['Bypass Study patients who returned for protocol-specified 1-year post-CABG coronary angiograms were included', 'Patients with a widely patent graft supplying the major diseased artery within each diseased coronary territory', 'After Coronary Artery Bypass Grafting']","['CR versus incomplete revascularization (IR', 'Coronary Angiography 1 Year', 'Complete revascularization (CR', 'coronary artery bypass graft (CABG) surgery', 'MACE']","['repeat revascularizations', 'cause mortality and major adverse cardiovascular events (MACE; all-cause mortality, nonfatal myocardial infarction, repeat revascularization', 'mortality', 'myocardial infarction']","[{'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",1276.0,0.137461,"Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p <0.01), but had no impact on mortality.","[{'ForeName': 'Brack', 'Initials': 'B', 'LastName': 'Hattler', 'Affiliation': 'Department of Medicine, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO; Department of Medicine, University of Colorado School of Medicine, Aurora, CO. Electronic address: brack.hattler@va.gov.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Grover', 'Affiliation': 'Department of Surgery, University of Colorado School of Medicine, Aurora, CO; Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Department of Veterans Affairs Palo Alto Health Economics Resource Center, Palo Alto, CA; Department of Surgery, Stanford University, Stanford, CA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Hawkins', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Quin', 'Affiliation': 'Department of Surgery, Veterans Affairs Boston Healthcare System, West Roxbury, MA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Collins', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Perry Point Veterans Affairs Medical Center, Perry Point, MD.'}, {'ForeName': 'Muath', 'Initials': 'M', 'LastName': 'Bishawi', 'Affiliation': 'Research and Development Office, Northport Veterans Affairs Medical Center, Northport, NY; Department of Surgery, Duke University, Durham, NC.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Almassi', 'Affiliation': 'Department of Surgery, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI; Department of Surgery, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Annie Laurie', 'Initials': 'AL', 'LastName': 'Shroyer', 'Affiliation': 'Research and Development Office, Northport Veterans Affairs Medical Center, Northport, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.047']
2354,32720478,Sacubitril/valsartan vs. angiotensin receptor inhibition in heart failure: a real-world study in Taiwan.,"AIMS


This study aimed to compare the efficacy of angiotensin receptor-neprilysin inhibitor (ARNI) therapy with angiotensin receptor blocker (ARB) therapy for cardiovascular outcomes in patients with heart failure (HF) with reduced ejection fraction.
METHODS AND RESULTS


Data were obtained from the Chang Gung Research Database. The cohort entry date of the ARB group was assigned as that of the ARNI group to avoid immortal time bias. Additionally, 1:1 propensity score matching based on age, sex, and baseline left ventricular ejection fraction was conducted. The expectation-maximization imputation method with inverse probability of treatment weighting was used to compare outcomes between the two groups. The primary outcome was a composite of cardiovascular death and hospitalization for worsening HF. Patients who received ARNI therapy had a significantly lower risk of the primary composite outcome occurring than patients who received ARBs (hazard ratio, 0.74; 95% confidence interval, 0.57-0.96). The reduction of hospitalization for worsening HF contributed most to the primary outcome benefits. In addition to the primary outcome, the ARNI group had a significantly lower risk of non-fatal myocardial infarction. The improvement of ejection fraction was not significantly different between the groups. The medication doses of ARNI were lower than in clinical trials.
CONCLUSIONS


In patients with HF with reduced ejection fraction, sacubitril/valsartan was superior to ARB therapy in reducing the occurrence of the primary outcome endpoint of hospitalization for worsening HF and cardiovascular death.",2020,"Patients who received ARNI therapy had a significantly lower risk of the primary composite outcome occurring than patients who received ARBs (hazard ratio, 0.74; 95% confidence interval, 0.57-0.96).","['patients with heart failure (HF) with reduced ejection fraction', 'Taiwan', 'heart failure']","['Sacubitril/valsartan vs. angiotensin receptor inhibition', 'ARNI therapy', 'angiotensin receptor-neprilysin inhibitor (ARNI) therapy with angiotensin receptor blocker (ARB) therapy']","['hospitalization for worsening HF and cardiovascular death', 'improvement of ejection fraction', 'composite of cardiovascular death and hospitalization for worsening HF', 'risk of non-fatal myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",,0.108667,"Patients who received ARNI therapy had a significantly lower risk of the primary composite outcome occurring than patients who received ARBs (hazard ratio, 0.74; 95% confidence interval, 0.57-0.96).","[{'ForeName': 'Po-Cheng', 'Initials': 'PC', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Fu-Chih', 'Initials': 'FC', 'LastName': 'Hsiao', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Ming-Shien', 'Initials': 'MS', 'LastName': 'Wen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Chien-Ying', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Chung-Chuan', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Pao-Hsien', 'Initials': 'PH', 'LastName': 'Chu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou and Chang Gung University, Medical School, 5 Fu-Xing Street, Guishan District, Taoyuan, 33305, Taiwan.'}]",ESC heart failure,['10.1002/ehf2.12924']
2355,32720628,Cost-effectiveness of WHO Problem Management Plus for adults with mood and anxiety disorders in a post-conflict area of Pakistan: randomised controlled trial.,"BACKGROUND


With the development of evidence-based interventions for treatment of priority mental health conditions in humanitarian settings, it is important to establish the cost-effectiveness of such interventions to enable their scale-up.
AIMS


To evaluate the cost-effectiveness of the Problem Management Plus (PM+) intervention compared with enhanced usual care (EUC) for common mental disorders in primary healthcare in Peshawar, Pakistan. Trial registration ACTRN12614001235695 (anzctr.org.au).
METHOD


We randomly allocated 346 participants to either PM+ (n = 172) or EUC (n = 174). Effectiveness was measured using the Hospital Anxiety and Depression Scale (HADS) at 3 months post-intervention. Cost-effectiveness analysis was performed as incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores.
RESULTS


The total cost of delivering PM+ per participant was estimated at PKR 16 967 (US$163.14) using an international trainer and supervisor, and PKR 3645 (US$35.04) employing a local trainer. The mean cost per unit score improvement in anxiety and depression symptoms on the HADS was PKR 2957 (95% CI 2262-4029) (US$28) with an international trainer/supervisor and PKR 588 (95% CI 434-820) (US$6) with a local trainer/supervisor. The mean incremental cost-effectiveness ratio (ICER) to successfully treat a case of depression (PHQ-9 ≥ 10) using an international supervisor was PKR 53 770 (95% CI 39 394-77 399) (US$517), compared with PKR 10 705 (95% CI 7731-15 627) (US$102.93) using a local supervisor.
CONCLUSIONS


The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.",2020,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","['53', 'common mental disorders in primary healthcare in Peshawar, Pakistan', 'adults with mood and anxiety disorders in a post-conflict area of Pakistan', '346 participants to either']","['WHO Problem Management', 'PM+ intervention', 'enhanced usual care (EUC', 'Problem Management Plus (PM+) intervention', 'PM', 'EUC', 'international supervisor was PKR']","['mean cost per unit score improvement in anxiety and depression symptoms', 'mean incremental cost-effectiveness ratio (ICER', 'incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores', 'symptoms of anxiety, depression and improving functioning', 'Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness', 'total cost of delivering PM']","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",346.0,0.173334,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","[{'ForeName': 'Syed Usman', 'Initials': 'SU', 'LastName': 'Hamdani', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK; and Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Zill-E-', 'Initials': 'ZE', 'LastName': 'Huma', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'WHO Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Farooq', 'Affiliation': 'Lady Reading Hospital, Peshawar, Pakistan; and School of Primary, Community and Social Care, Keele University, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.138']
2356,32719274,Clinical and dosimetric impact of adaptive intensity-modulated radiotherapy in locally advanced head-and-neck cancer.,"Background


Radiotherapy in head-and-neck cancer (HNC) is a challenging task, and the anatomical alterations occurring during the course of intensity-modulated radiotherapy (IMRT) can be compensated by adaptive radiotherapy (ART) which utilizes repeat computed tomography (CT) scans during the treatment course for replanning. In this study, the clinical and dosimetric benefits of ART were compared with the conventional IMRT.
Materials and Methods


Sixty patients with locally advanced HNC were randomized into two arms to receive IMRT up to a curative dose of 70 Gy with concurrent weekly chemotherapy and were prospectively analyzed between March 2018 and March 2019. Repeat CT scan was acquired after the 3 rd  week of radiation. Patients in the study arm underwent replanning, whereas those in the control arm continued with the first IMRT plan. Assessment was done weekly till the end of treatment and at 1, 3, and 6 months post IMRT for disease response and toxicities. Tumor volume reduction rate (TVRR) and dose reduction to organs at risk were also recorded.
Results


Complete response was observed in 90% and 96.7% patients in the control and study arms, respectively, at the end of 6 months. Insignificant differences were found between the two arms in terms of toxicities. Xerostomia was statistically significantly higher in the control arm at 6 months (P = 0.01). TVRR was found to be 31.85%. Dose to spinal cord, ipsilateral, and contralateral parotid reduced by 4.3%, 6%, and 2.2%, respectively, with ART.
Conclusion


Mid-treatment adaptive replanning can help in better target coverage and minimize toxicities in HNC patients.",2020,Xerostomia was statistically significantly higher in the control arm at 6 months (P = 0.01).,"['head-and-neck cancer (HNC', 'HNC patients', 'locally advanced head-and-neck cancer', 'Sixty patients with locally advanced HNC']","['adaptive radiotherapy (ART) which utilizes repeat computed tomography (CT) scans', 'IMRT up to a curative dose of 70 Gy with concurrent weekly chemotherapy', 'adaptive intensity-modulated radiotherapy', '\n\n\nRadiotherapy', 'intensity-modulated radiotherapy (IMRT']","['target coverage and minimize toxicities', 'Complete response', 'toxicities', 'TVRR', 'disease response and toxicities', 'Repeat CT scan', 'Tumor volume reduction rate (TVRR) and dose reduction to organs at risk', 'Xerostomia']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",60.0,0.0304342,Xerostomia was statistically significantly higher in the control arm at 6 months (P = 0.01).,"[{'ForeName': 'Guncha', 'Initials': 'G', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Radiation Oncology, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Dhanawat', 'Affiliation': 'Department of Internal Medicine, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Harvindra S', 'Initials': 'HS', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiation Oncology, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiation Oncology, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Shankar Lal', 'Initials': 'SL', 'LastName': 'Jakhar', 'Affiliation': 'Department of Radiation Oncology, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_928_19']
2357,32723555,Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial).,"The SURTAVI trial demonstrated the noninferiority of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. Most TAVI patients received an early generation device which is no longer commercially available. This analysis compares TAVI outcomes in patients that received the Evolut R valve to those of similar patients randomized to SAVR in the SURTAVI trial. The continued access study of SURTAVI (CAS) enrolled 290 patients. Of them, 252 were implanted with the 23, 26, or 29 mm Evolut R device. Propensity-score matching between this group and SURTAVI SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis. The primary end point for comparison was the rate of all-cause mortality or disabling stroke at 1-year. The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). At 1-year TAVI was numerically favored (4.1% vs 8.2%; p = 0.082). In conclusion, compared with SAVR, TAVI using Evolut R had a favorable 30-day safety profile, significantly better hemodynamic performance, and a comparable 1-year rate of all-cause mortality or disabling stroke, suggesting this may be a preferred treatment for patients with severe, symptomatic aortic stenosis at intermediate surgical risk.",2020,TAVI was numerically favored (4.1% vs 8.2%; p = 0.082).,"['290 patients', 'SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis', 'patients with severe, symptomatic aortic stenosis at intermediate surgical risk']","['surgical aortic valve replacement (SAVR', 'Evolut-R Transcatheter Aortic Valve Implantation With Surgery', 'transcatheter aortic valve implantation (TAVI']","['rate of all-cause mortality or disabling stroke', 'TAVI', 'hemodynamic performance']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",290.0,0.0633674,TAVI was numerically favored (4.1% vs 8.2%; p = 0.082).,"[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Riverside Methodist - Ohio Health, Columbus, Ohio. Electronic address: steven.yakubov@ohiohealth.com.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Hemal', 'Initials': 'H', 'LastName': 'Gada', 'Affiliation': 'University of Pittsburgh Medical Center Pinnacle Heath, Harrisburg, Pennsylvania.'}, {'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'University of Pittsburgh Medical Center Pinnacle Heath, Harrisburg, Pennsylvania.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'University of Michigan Hospitals, Ann Arbor, Michigan.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Structural Heart and Valve Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'George', 'Affiliation': 'Structural Heart and Valve Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Kleiman', 'Affiliation': 'Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Chetcuti', 'Affiliation': 'University of Michigan Hospitals, Ann Arbor, Michigan.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchez', 'Affiliation': 'Riverside Methodist - Ohio Health, Columbus, Ohio.'}, {'ForeName': 'Harold L', 'Initials': 'HL', 'LastName': 'Dauerman', 'Affiliation': 'University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.051']
2358,32725998,Impact of Angiotensin II Receptor Blockers on Clinical Outcomes after Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction Based on Data from the Korean National Health Insurance Database (2005-2014).,"BACKGROUND AND OBJECTIVES


The effectiveness of angiotensin II receptor blockers (ARBs) compared with angiotensin converting enzyme inhibitors (ACEIs) in patients with acute myocardial infarction (AMI) has not been established. We investigated the effects of ARBs on clinical outcomes after percutaneous coronary intervention (PCI) in AMI patients.
METHODS


Patients receiving ACEIs or ARBs after AMI treated with PCI between January 2005 and December 2014 were selected from the Korean National Health Insurance Service database. The primary endpoint was major cardiovascular adverse event (MACE; all-cause death, myocardial infarct [MI], or stroke).
RESULTS


We included patients regularly taking ACEIs (n=22,331) or ARBs (n=28,533) (medication possession ratio ≥80%). Compared with the ACEI group, the ARB group contained more females (31% vs. 18%), were older (mean, 63 vs. 60 years), and had more comorbidities, including hypertension (62.8% vs. 44.8%), diabetes (33.9% vs. 26.4%), congestive heart failure (7.9% vs. 4.3%), chronic obstructive pulmonary disease (25.5% vs. 18.9%), and end-stage renal disease (1.3% vs. 0.4%) (p<0.001 for all). After propensity score-matching, ARBs were associated with a 23% lower risk of MACE (hazard ratio [HR], 0.774; 95% confidence interval [CI], 0.715-0.838; p<0.001) than ACEIs. ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
CONCLUSIONS


ARB use was associated with a lower risk of MACE, MI, and revascularization than ACEIs in our retrospective analysis of AMI patients who underwent PCI.",2020,"ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
","['Patients receiving ACEIs or ARBs after AMI treated with PCI between January 2005 and December 2014 were selected from the Korean National Health Insurance Service database', 'patients regularly taking ACEIs (n=22,331) or ARBs (n=28,533) (medication possession ratio ≥80', 'AMI patients', 'patients with acute myocardial infarction (AMI', 'Patients with Acute Myocardial Infarction Based on Data from the Korean National Health Insurance Database (2005-2014']","['percutaneous coronary intervention (PCI', 'Percutaneous Coronary Intervention', 'ACEI', 'ARB', 'Angiotensin II Receptor Blockers', 'ARBs', 'angiotensin converting enzyme inhibitors (ACEIs', 'angiotensin II receptor blockers (ARBs']","['chronic obstructive pulmonary disease', 'diabetes', 'risk of death', 'major cardiovascular adverse event (MACE; all-cause death, myocardial infarct [MI], or stroke', 'congestive heart failure', 'stage renal disease', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.17824,"ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
","[{'ForeName': 'Gwang Sil', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Sanggye-Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. ygko@yuhs.ac.'}, {'ForeName': 'Yongsung', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Cardiology, Myeongji Hospital, Goyang, Korea.'}, {'ForeName': 'Hoyoun', 'Initials': 'H', 'LastName': 'Won', 'Affiliation': 'Cardiovascular & Arrhythmia Center, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Chul Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Myeong Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}]",Korean circulation journal,['10.4070/kcj.2020.0057']
2359,32722799,Quantification of Fluid Resolution and Visual Acuity Gain in Patients With Diabetic Macular Edema Using Deep Learning: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Large amounts of optical coherence tomographic (OCT) data of diabetic macular edema (DME) are acquired, but many morphologic features have yet to be identified and quantified.
Objective


To examine the volumetric change of intraretinal fluid (IRF) and subretinal fluid (SRF) in DME during anti-vascular endothelial growth factor treatment using deep learning algorithms.
Design, Setting, and Participants


This post hoc analysis of a randomized clinical trial, the Diabetic Retinopathy Clinical Research Network (protocol T), assessed 6945 spectral-domain OCT volume scans of 570 eyes from 570 study participants with DME. The original trial was performed from August 21, 2012, to October 18, 2018. This analysis was performed from December 7, 2017, to January 15, 2020.
Interventions


Participants were treated according to a predefined, standardized protocol with aflibercept, ranibizumab, or bevacizumab with or without deferred laser.
Main Outcomes and Measures


The association of treatment with IRF and SRF volumes and best-corrected visual acuity (BCVA) during 12 months using deep learning algorithms.
Results


Among the 570 study participants (302 [53%] male; 369 [65%] white; mean [SD] age, 43.4 [12.6] years), the mean fluid volumes in the central 3 mm were 448.6 nL (95% CI, 412.3-485.0 nL) of IRF and 36.9 nL (95% CI, 27.0-46.7 nL) of SRF at baseline and 161.2 nL (95% CI, 135.1-187.4 nL) of IRF and 4.4 nL (95% CI, 1.7-7.1 nL) of SRF at 12 months. The presence of SRF at baseline was associated with a worse baseline BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) score of 63.2 (95% CI, 60.2-66.1) (approximate Snellen equivalent of 20/63 [95% CI, 20/50-20/63]) in eyes with SRF vs 66.9 (95% CI, 65.7-68.1) (approximate Snellen equivalent, 20/50 [95% CI, 20/40-20/50]) without SRF (P < .001) and a greater gain in ETDRS score (0.5; 95% CI, 0.3-0.8) every 4 weeks during follow-up in eyes with SRF at baseline vs 0.4 (95% CI, 0.3-0.5) in eyes without SRF at baseline (P = .02) when adjusted for baseline BCVA. Aflibercept was associated with greater reduction of IRF volume compared with bevacizumab after the first injection (difference, 79.8 nL; 95% CI, 5.3-162.5 nL; P < .001) and every 4 weeks thereafter (difference, 10.4 nL; 95% CI, 0.7-20.0 nL; P = .004). Ranibizumab was associated with a greater reduction of IRF after the first injection compared with bevacizumab (difference, 75.2 nL; 95% CI, 1.4-154.7 nL; P < .001).
Conclusions and Relevance


Automated segmentation of fluid in DME revealed that the presence of SRF was associated with lower baseline BCVA but with good response to anti-vascular endothelial growth factor therapy. These automated spectral-domain OCT analyses may be used clinically to assess anatomical change during therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01627249.",2020,"Aflibercept was associated with greater reduction of IRF volume compared with bevacizumab after the first injection (difference, 79.8 nL; 95% CI, 5.3-162.5 nL; P < .001) and every 4 weeks thereafter (difference, 10.4 nL; 95% CI, 0.7-20.0 nL; P = .004).","['August 21, 2012, to October 18, 2018', 'diabetic macular edema (DME', '570 study participants (302 [53%] male; 369 [65%] white; mean [SD] age, 43.4 [12.6] years), the mean fluid volumes in the central 3 mm were 448.6 nL (95% CI, 412.3-485.0 nL) of IRF and 36.9 nL (95% CI, 27.0-46.7 nL) of SRF at baseline and 161.2 nL (95% CI, 135.1-187.4 nL) of IRF and 4.4 nL (95% CI, 1.7-7.1 nL) of SRF at 12 months', '570 eyes from 570 study participants with DME', 'December 7, 2017, to January 15, 2020', 'Patients With Diabetic Macular Edema Using Deep Learning']","['Fluid Resolution and Visual Acuity Gain', 'optical coherence tomographic (OCT) data', 'Aflibercept', 'intraretinal fluid (IRF) and subretinal fluid (SRF', 'Ranibizumab', 'BCVA', 'aflibercept, ranibizumab, or bevacizumab with or without deferred laser', 'bevacizumab']","['IRF volume', 'greater gain in ETDRS score', 'association of treatment with IRF and SRF volumes and best-corrected visual acuity ', 'IRF', 'baseline BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) score']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",570.0,0.60231,"Aflibercept was associated with greater reduction of IRF volume compared with bevacizumab after the first injection (difference, 79.8 nL; 95% CI, 5.3-162.5 nL; P < .001) and every 4 weeks thereafter (difference, 10.4 nL; 95% CI, 0.7-20.0 nL; P = .004).","[{'ForeName': 'Philipp K', 'Initials': 'PK', 'LastName': 'Roberts', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Vogl', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bianca S', 'Initials': 'BS', 'LastName': 'Gerendas', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Bogunovic', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Ursula M', 'Initials': 'UM', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2457']
2360,32729887,Cost-effectiveness of Breast Cancer Screening With Magnetic Resonance Imaging for Women at Familial Risk.,"Importance


For women with a 20% or more familial risk of breast cancer without a known BRCA1/2 (BRCA1, OMIM 113705; and BRCA2, OMIM 114480) or TP53 (OMIM 151623) variant, screening guidelines vary substantially, and cost-effectiveness analyses are scarce.
Objective


To assess the cost-effectiveness of magnetic resonance imaging (MRI) screening strategies for women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant.
Design, Setting, and Participants


In this economic evaluation, conducted from February 1, 2019, to May 25, 2020, microsimulation modeling was used to estimate costs and effectiveness on a lifetime horizon from age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant. A Dutch screening setting was modeled. Most data were obtained from the randomized Familial MRI Screening (FaMRIsc) trial, which included Dutch women aged 30 to 55 years. A health care payer perspective was applied.
Interventions


Several screening protocols with varying ages and intervals including those of the randomized FaMRIsc trial, consisting of the mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography).
Main Outcomes and Measures


Costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated and discounted by 3%. A threshold of €22 000 (US $24 795.87) per QALY was applied.
Results


This economic evaluation modeling study estimated that, on a lifetime horizon per 1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22 885 QALYs and total costs of €7 084 767 (US $7 985 134.61). The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65). Magnetic resonance imaging performed only every 18 months between the ages of 35 and 60 years followed by the national screening program was considered optimal, with an ICER of €21 380 (US $24 097.08) compared with the previous nondominated strategy in the ranking, when applying the National Institute for Health and Care Excellence threshold. Annual screening alternating MRI and mammography between the ages of 35 and 60 years, followed by the national screening program, gave similar outcomes. Higher thresholds would favor annual MRI screening. The ICER was most sensitive to the unit cost of MRI and the utility value for ductal carcinoma in situ and localized breast cancer.
Conclusions and Relevance


This study suggests that MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer is cost-effective within the National Institute for Health and Care Excellence threshold for all densities. Higher thresholds would favor annual MRI screening. These outcomes support a change of current screening guidelines for this specific risk group and support MRI screening.",2020,The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65).,"['age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant', 'Dutch women aged 30 to 55 years', 'Women at Familial Risk', '1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22\u202f885 QALYs and total costs of €7\u202f084\u202f767 (US $7\u202f985\u202f134.61', 'women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant', 'MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer']","['Magnetic resonance imaging', 'mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography', 'Breast Cancer Screening With Magnetic Resonance Imaging', 'magnetic resonance imaging (MRI) screening strategies']","['Measures\n\n\nCosts, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1261325', 'cui_str': 'Family history of breast cancer'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",0.0,0.0459929,The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65).,"[{'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Inge-Marie', 'Initials': 'IM', 'LastName': 'Obdeijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Emiel J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Saadatmand', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ritse M', 'Initials': 'RM', 'LastName': 'Mann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Oosterwijk', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Rob A E M', 'Initials': 'RAEM', 'LastName': 'Tollenaar', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Diderick B W', 'Initials': 'DBW', 'LastName': 'de Roy van Zuidewijn', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Marc B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Martijne', 'Initials': 'M', 'LastName': ""van 't Riet"", 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, the Netherlands.'}, {'ForeName': 'Maartje J', 'Initials': 'MJ', 'LastName': 'Hooning', 'Affiliation': 'Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Margreet G E M', 'Initials': 'MGEM', 'LastName': 'Ausems', 'Affiliation': 'Department of Genetics, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Claudette E', 'Initials': 'CE', 'LastName': 'Loo', 'Affiliation': 'Department of Radiology and Nuclear Medicine, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Wesseling', 'Affiliation': 'Department of Pathology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Ernest J T', 'Initials': 'EJT', 'LastName': 'Luiten', 'Affiliation': 'Department of Surgery, Amphia Ziekenhuis, Breda, the Netherlands.'}, {'ForeName': 'Harmien M', 'Initials': 'HM', 'LastName': 'Zonderland', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Madeleine M A', 'Initials': 'MMA', 'LastName': 'Tilanus-Linthorst', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.2922']
2361,32729897,Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial.,"Importance


Faricimab neutralizes angiopoietin-2 and vascular endothelial growth factor A via both simultaneous and independent binding.
Objective


To evaluate extended dosing with faricimab, the first bispecific antibody designed for intraocular use, in patients with neovascular age-related macular degeneration.
Design, Setting, and Participants


This phase 2 randomized clinical trial was a 52-week multicenter, active comparator-controlled, parallel-group study. Study participants were enrolled in 25 sites in the US from January and March 2017 with treatment-naive choroidal neovascularization secondary to neovascular age-related macular degeneration and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score of 73 (approximate Snellen equivalent, 20/40) to 24 (approximate Snellen equivalent, 20/320). Analysis began January 2017 and ended March 2018.
Interventions


Participants were randomized 1:2:2 to receive intravitreal ranibizumab, 0.5 mg, every 4 weeks or faricimab, 6.0 mg, every 12 or 16 weeks. Participants in the faricimab arms initially received 4 monthly injections of faricimab. No rescue injections were allowed. Participants randomized to dosing every 16 weeks were assessed for disease activity at week 24 using prespecified criteria. Those with no active disease continued dosing every 16 weeks through trial end; participants with disease activity continued received dosing every 12 weeks.
Main Outcomes and Measures


Mean change in BCVA from baseline at week 40.
Results


Of 76 participants enrolled (mean [SD] age, 78.5 [8.5] years; age range, 56-94 years; 41 women [58%]; 69 white [97%]), 16 (21.0%) were randomized to ranibizumab every 4 weeks, 29 (38.2%) to faricimab every 12 weeks, and 31 (40.8%) to faricimab every 16 weeks. At week 24, 12 weeks after their last initiation injection, 65% (36 of 55) of all faricimab-treated participants had no disease activity. At week 40, adjusted mean BCVA gains from baseline (Early Treatment Diabetic Retinopathy Study letters) were +11.4 (80% CI, 7.8-15.0), +9.3 (80% CI, 6.4-12.3), and +12.5 (80% CI, 9.9-15.1) for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively. Participants received a mean (SD) total of 12.9 (0.25), 6.7 (0.91), and 6.2 (0.93) injections, for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively, through week 52. The secondary BCVA and anatomical imaging end points supported the primary end point and were comparable with ranibizumab every 4 weeks. No new or unexpected safety signals were identified.
Conclusions and Relevance


At week 52, faricimab dosing every 16 weeks and every 12 weeks resulted in maintenance of initial vision and anatomic improvements comparable with monthly ranibizumab. These results suggest a role for simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A in providing sustained efficacy through extended durability, warranting further investigation.
Trial Registration


ClinicalTrials.gov Identifier: NCT03038880.",2020,The secondary BCVA and anatomical imaging end points supported the primary end point and were comparable with ranibizumab every 4 weeks.,"['76 participants enrolled (mean [SD] age, 78.5 [8.5] years; age range, 56-94 years', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration', ' 41 women [58%]; 69 white [97%]), 16 (21.0', 'Study participants were enrolled in 25 sites in the US from January and March 2017 with treatment-naive choroidal neovascularization secondary to neovascular age-related macular degeneration and best-corrected visual acuity (BCVA']","['faricimab', 'Faricimab vs Ranibizumab', 'intravitreal ranibizumab', 'ranibizumab']","['disease activity', 'mean BCVA gains']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",76.0,0.243984,The secondary BCVA and anatomical imaging end points supported the primary end point and were comparable with ranibizumab every 4 weeks.,"[{'ForeName': 'Arshad M', 'Initials': 'AM', 'LastName': 'Khanani', 'Affiliation': 'Sierra Eye Associates, Reno, Nevada.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ferrone', 'Affiliation': 'Long Island and Queens Vitreoretinal Consultants, PC, Great Neck, New York.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Osborne', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sahni', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Grzeschik', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basu', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Ehrlich', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Haskova', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2699']
2362,32729273,Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial.,"OBJECTIVE


We aimed to assess the effects of remote ischemic pre-conditioning (RIPC) on the incidence of contrast-induced nephropathy (CIN) after an intravenous (IV) or intra-arterial injection of contrast medium (CM) in patient and control groups.
MATERIALS AND METHODS


This prospective, randomized, single-blinded, controlled trial included 26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six. All the patients underwent four cycles of five minute-blood pressure cuff inflation followed by five minutes of total deflation. In the RIPC group (n = 13), the cuff was inflated to 50 mm Hg above the patient's systolic blood pressure (SBP); in the control group (n = 13), it was inflated to 10 mm Hg below the patient's SBP. The primary endpoint was the occurrence of CIN. Additionally, variation in the serum levels of cystatin C was assessed.
RESULTS


One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients). Mean creatinine values at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 88 ± 32 μmol/L, 91 ± 28 μmol/L and 82 ± 29 μmol/L, respectively ( p  = 0.73) in the RIPC group, whereas in the control group, they were 100 ± 36 μmol/L, 110 ± 36 μmol/L, and 105 ± 34 μmol/L, respectively ( p  = 0.78). Cystatin C values (median [Q1, Q3]) at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 1.10 [1.08, 1.18] mg/L, 1.17 [0.97, 1.35] mg/L, and 1.12 [0.99, 1.24] mg/L, respectively ( p  = 0.88) in the RIPC group, whereas they were 1.11 [0.97, 1.28] mg/L, 1.13 [1.08, 1.25] mg/L, and 1.16 [1.03, 1.31] mg/L, respectively ( p  = 0.93), in the control group.
CONCLUSION


The risk of CIN after an IV injection of CM is very low in patients with Mehran risk score greater than or equal to six and even in the patients who are unable to receive preventive hyperhydration. Hence, the Mehran risk score may not be an appropriate method for the estimation of the risk of CIN after IV CM injection.",2020,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","['patient and control groups', '26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six']","['Intravenous Contrast Medium Injection', 'remote ischemic pre-conditioning (RIPC', 'intravenous (IV) or intra-arterial injection of contrast medium (CM', 'Remote Ischemic Pre-Conditioning']","['incidence of contrast-induced nephropathy (CIN', 'Mean creatinine values', 'Cystatin C values (median [Q1, Q3', 'serum levels of cystatin C', 'CIN', 'occurrence of CIN', 'systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0021487', 'cui_str': 'Intra-arterial injection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",26.0,0.0690735,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","[{'ForeName': 'Dihia', 'Initials': 'D', 'LastName': 'Belabbas', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Radiodology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Chaudru', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Lederlin', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Le Pabic', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boulmier', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Heautot', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mahe', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France. maheguillaume@yahoo.fr.'}]",Korean journal of radiology,['10.3348/kjr.2019.0916']
2363,32729275,Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial.,"OBJECTIVE


To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs).
MATERIALS AND METHODS


In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator.
RESULTS


Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585). No procedural or post-procedural complications were identified.
CONCLUSION


Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.",2020,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"['39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis', 'Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas', 'n = 19, PBA group) between June 2016 and June 2018', 'dysfunctional radiocephalic arteriovenous fistulas (RCAVFs']","['Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty', 'drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA', 'DBA and PBA', 'Paclitaxel-coated balloon', 'PBA alone']","['Technical and clinical success rates', 'mean duration of TLPP', 'No procedural or post-procedural complications', 'TLPP or TLSP', 'technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1141930', 'cui_str': 'Post procedural complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0701242,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"[{'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. ho7ok7@gilhospital.com.'}, {'ForeName': 'Sung Su', 'Initials': 'SS', 'LastName': 'Byun', 'Affiliation': 'Health Promotion Center, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Korean journal of radiology,['10.3348/kjr.2020.0067']
2364,32729888,Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial.,"Importance


Faricimab, the first bispecific antibody designed for intraocular use, simultaneously and independently binds and neutralizes angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
Objective


To assess the efficacy and safety of different doses and regimens of faricimab vs ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
Design, Setting, and Participants


AVENUE was a 36-week, multiple-dose-regimen, active comparator-controlled, double-masked, phase 2 randomized clinical study performed at 58 sites in the United States. Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320). Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017. Data were analyzed from August 11, 2015, to October 4, 2019.
Interventions


Patients were randomized 3:2:2:2:3 to receive ranibizumab, 0.5 mg every 4 weeks (arm A [n = 68]); faricimab, 1.5 mg every 4 weeks (arm B [n = 47]); faricimab, 6.0 mg every 4 weeks (arm C [n = 42]); faricimab, 6.0 mg every 4 weeks until week 12, then faricimab, 6.0 mg every 8 weeks (arm D [n = 47]); and ranibizumab, 0.5 mg every 4 weeks until week 8, then faricimab, 6.0 mg every 4 weeks (arm E [n = 69]).
Main Outcomes and Measures


Mean change in BCVA from baseline to week 36, proportion of participants gaining at least 15 letters, BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes in anti-VEGF treatment-naive participants (arms A, B, C, D) and from weeks 12 to 36 in those with incomplete response (participants in arms A and E with week 12 BCVA ETDRS letter score of ≤68 [Snellen equivalent, 20/50 or worse]).
Results


A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years). At week 36, adjusted mean change in BCVA vs ranibizumab was 1.6 (80% CI, -1.6 to 4.7) letters for arm B (P = .52), -1.6 (80% CI, -4.9 to 1.7) letters for arm C (P = .53), and -1.5 (80% CI, -4.6 to 1.6) letters for arm D (P = .53). For arm E, adjusted mean change from week 12 was -1.7 (80% CI, -3.8 to 0.4) letters (P = .30).
Conclusions and Relevance


AVENUE did not meet its primary end point of superiority of faricimab over ranibizumab in BCVA at week 36. Although not superior to monthly ranibizumab as given in this trial, overall visual and anatomical gains noted with faricimab support pursuing phase 3 trials for a potential alternative to monthly anti-VEGF therapy. Faricimab showed no new or unexpected safety signals.
Trial Registration


ClinicalTrials.gov Identifier: NCT02484690.",2020,"For arm E, adjusted mean change from week 12 was -1.7","['Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017', 'A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years', 'Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration (nAMD', 'Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA']","['faricimab vs ranibizumab', 'Faricimab vs Ranibizumab', 'BCVA', 'ranibizumab']","['efficacy and safety', 'BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes', 'Safety and Efficacy']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",263.0,0.321469,"For arm E, adjusted mean change from week 12 was -1.7","[{'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sahni', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Chittum', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shamil', 'Initials': 'S', 'LastName': 'Sadikhov', 'Affiliation': 'Roche Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Szczesny', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Everson', 'Initials': 'E', 'LastName': 'Nogoceke', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weikert', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2685']
2365,32728111,Efficacy of combined orthokeratology and 0.01% atropine solution for slowing axial elongation in children with myopia: a 2-year randomised trial.,"Eighty Japanese children, aged 8-12 years, with a spherical equivalent refraction (SER) of - 1.00 to - 6.00 dioptres (D) were randomly allocated into two groups to receive either a combination of orthokeratology (OK) and 0.01% atropine solution (combination group) or monotherapy with OK (monotherapy group). Seventy-three subjects completed the 2-year study. Over the 2 years, axial length increased by 0.29 ± 0.20 mm (n = 38) and 0.40 ± 0.23 mm (n = 35) in the combination and monotherapy groups, respectively (P = 0.03). Interactions between combination treatment and age or SER did not reach significance level (age, P = 0.18; SER, P = 0.06). In the subgroup of subjects with an initial SER of - 1.00 to - 3.00 D, axial length increased by 0.30 ± 0.22 mm (n = 27) and 0.48 ± 0.22 mm (n = 23) in the combination and monotherapy groups, respectively (P = 0.005). In the - 3.01 to - 6.00 D subgroup, axial length increased by 0.27 ± 0.15 mm (n = 11) and 0.25 ± 0.17 mm (n = 12) in the combination and monotherapy groups, respectively (P = 0.74). The combination therapy may be effective for slowing axial elongation, especially in children with low initial myopia.",2020,"Interactions between combination treatment and age or SER did not reach significance level (age, P = 0.18; SER, P = 0.06).","['Seventy-three subjects completed the 2-year study', 'children with myopia', 'Eighty Japanese children, aged 8-12\xa0years, with a spherical equivalent refraction (SER) of -\u20091.00 to -\u20096.00 dioptres (D', 'children with low initial myopia']","['combination of orthokeratology (OK) and 0.01% atropine solution (combination group) or monotherapy with OK (monotherapy', 'combined orthokeratology and 0.01% atropine solution']",['axial length'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",80.0,0.0902463,"Interactions between combination treatment and age or SER did not reach significance level (age, P = 0.18; SER, P = 0.06).","[{'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Ophthalmology, Saitama Medical Centre, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan. nozomik@omiya.jichi.ac.jp.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Konno', 'Affiliation': 'Konno Eye Clinic, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hamada', 'Affiliation': 'Omiya Hamada Eye Clinic, Saitama, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Department of Hematology, Saitama Medical Centre, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Shimmura-Tomita', 'Affiliation': 'Department of Ophthalmology, Saitama Medical Centre, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan.'}, {'ForeName': 'Toshikatsu', 'Initials': 'T', 'LastName': 'Kaburaki', 'Affiliation': 'Department of Ophthalmology, Saitama Medical Centre, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Kakehashi', 'Affiliation': 'Department of Ophthalmology, Saitama Medical Centre, Jichi Medical University, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan.'}]",Scientific reports,['10.1038/s41598-020-69710-8']
2366,32727707,Randomized Study of Maintenance Pemetrexed Versus Observation for Treatment of Malignant Pleural Mesothelioma: CALGB 30901.,"BACKGROUND


The role of maintenance therapy for malignant pleural mesothelioma (MPM) is unknown. We performed a randomized phase II trial to determine if continuation of pemetrexed after first-line pemetrexed and platinum would improve progression-free survival (PFS).
PATIENTS AND METHODS


Eligible patients with unresectable MPM, without disease progression following 4 to 6 cycles of pemetrexed and platinum were randomized 1:1 to observation or continuation of pemetrexed until progression, stratified by number of cycles (< 6 or 6), cis- or carboplatin containing regimen, and histology. Study size was calculated based on the assumption that observation would produce a median PFS of 3 months and pemetrexed would yield median PFS of 6 months.
RESULTS


A total of 72 patients were registered from December 2010 to June 2016. The study closed early after 53 patients were randomized; 49 eligible (22 on the observation arm and 27 on the pemetrexed arm) were included in the analysis. The median PFS was 3 months (95% confidence interval [CI], 2.6-11.9 months) on observation and 3.4 months (95% CI, 2.8-9.8 months) on pemetrexed (hazard ratio [HR], 0.99; 95% CI, 0.51-1.90; P = .9733). The median overall survival (OS) was 11.8 months (95% CI, 9.3-28.7 months) for observation, and 16.3 months (95% CI, 10.5-26.0 months) for pemetrexed (HR, 0.86; 95% CI, 0.44-1.71; P = .6737). Grade 3 or 4 toxicities on the pemetrexed arm included anemia (8%), lymphopenia (8%), neutropenia (4%), and fatigue (4%). A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
CONCLUSION


Maintenance pemetrexed following initial pemetrexed and platinum chemotherapy does not improve PFS in patients with MPM.",2020,"A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
","['patients with MPM', 'malignant pleural mesothelioma (MPM', '53 patients were randomized; 49 eligible (22 on the observation arm and 27 on the pemetrexed arm) were included in the analysis', '72 patients were registered from December 2010 to June 2016', 'Eligible patients with unresectable MPM, without disease progression following 4 to 6 cycles of']","['cis- or carboplatin containing regimen, and histology', 'pemetrexed and platinum chemotherapy', 'pemetrexed and platinum', 'pemetrexed after first-line pemetrexed and platinum', 'Maintenance Pemetrexed']","['PFS', 'neutropenia', 'median overall survival (OS', 'anemia', 'Grade 3 or 4 toxicities', 'lymphopenia', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",72.0,0.170713,"A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
","[{'ForeName': 'Arkadiusz Z', 'Initials': 'AZ', 'LastName': 'Dudek', 'Affiliation': 'Regions Cancer Care Center, HealthPartners Inc, Minneapolis, MN. Electronic address: arkadiusz.z.dudek@healthpartners.com.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Duong', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kratzke', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota/Masonic Cancer Center, Minneapolis, MN.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Hedy L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'Department of Medicine, University of Chicago Comprehensive Cancer Center, Chicago, IL.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.025']
2367,32727835,Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study.,"OBJECTIVE


The phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868) assessed responses to selected vaccines in ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis.
METHODS


Patients were randomized 2:1 into the OCR group (n = 68; OCR 600 mg) or control group (n = 34; interferon beta or no disease-modifying therapy). All received tetanus toxoid (TT)-containing vaccine, Pneumovax (23-valent pneumococcal polysaccharide vaccine [23-PPV]), and keyhole limpet hemocyanin (KLH). The OCR group was subdivided into OCR1 (n = 33) and OCR2 (n = 35) at randomization. The OCR1 group received Prevnar (13-valent conjugate pneumococcal vaccine) 4 weeks after 23-PPV; the OCR2 and control groups received influenza vaccine. Vaccinations started 12 weeks after OCR initiation (OCR group) or on day 1 (control group).
RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. Positive response rate to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in the OCR and 100% in the control group. Prevnar did not enhance response to pneumococcal serotypes in common with Pneumovax. Humoral response to KLH was decreased in the OCR vs control group. Seroprotection rates at 4 weeks against 5 influenza strains ranged from 55.6% to 80.0% in the OCR2 group and 75.0% to 97.0% in the control group.
CONCLUSION


Peripherally B-cell-depleted OCR recipients mounted attenuated humoral responses to clinically relevant vaccines and the neoantigen KLH, suggesting that use of standard nonlive vaccines while on OCR treatment remains a consideration. For seasonal influenza vaccines, it is recommended to vaccinate patients on OCR because a potentially protective humoral response, even if attenuated, can be expected.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence confirming that the humoral response to nonlive vaccines in patients with relapsing multiple sclerosis after OCR treatment is attenuated compared with untreated or interferon beta-treated patients, but they can still be expected to be protective.
CLINICALTRIALSGOV IDENTIFIER


NCT02545868.",2020,"RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","['patients with multiple sclerosis', 'Patients were randomized 2:1 into Group OCR (n=68', 'ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis']","['interferon-β or no disease-modifying therapy', 'tetanus toxoid (TT)-containing vaccine, Pneumovax® (23-PPV) and keyhole limpet hemocyanin (KLH', 'TT vaccine', 'influenza vaccine', 'OCR2', 'ocrelizumab', 'interferon-β-treated', 'OCR1 received Prevnar® (13-PCV']","['Humoral response to KLH', 'Seroprotection rates', 'Positive response rate', 'vaccine responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071315', 'cui_str': 'Pneumovax'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0305062', 'cui_str': 'tetanus toxoid vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0876134', 'cui_str': 'Prevnar'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0381286,"RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada. amitbar@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Calkwood', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Chognot', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Evershed', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Derrick S', 'Initials': 'DS', 'LastName': 'Robertson', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Stokmaier', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Wendt', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}]",Neurology,['10.1212/WNL.0000000000010380']
2368,32731259,A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study.,"Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenström macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib. The primary end point was the proportion of patients achieving a complete response (CR) or a very good partial response (VGPR) by independent review. Key secondary end points included major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety. A total of 201 patients were randomized, and 199 received ≥1 dose of study treatment. No patient achieved a CR. Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P = .09). MRRs were 77% and 78%, respectively. Median DOR and PFS were not reached; 84% and 85% of ibrutinib and zanubrutinib patients were progression free at 18 months. Atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia, as well as adverse events leading to treatment discontinuation, were less common among zanubrutinib recipients. Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events per 100 person-months). These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.",2020,"Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events/100 person-months).","['201 patients', 'Patients with MYD88L265P disease', 'patients with Waldenström macroglobulinemia (WM', 'patients with WM']","['Bruton tyrosine kinase (BTK) inhibition', 'ibrutinib or zanubrutinib']","['major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety', 'Incidence of atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia', 'proportion of patients achieving a complete or very good partial response (CR or VGPR', 'grade ≥3 infection rates', 'MRRs', 'response quality and less toxicity, particularly cardiovascular toxicity', 'Median DOR and PFS', 'efficacy and safety', 'Incidence of neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024419', 'cui_str': ""Waldenstrom's macroglobulinemia""}]","[{'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C4683810', 'cui_str': 'zanubrutinib'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",201.0,0.0497721,"Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events/100 person-months).","[{'ForeName': 'Constantine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Opat', 'Affiliation': 'Monash Health, Clayton, VIC, Australia.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': ""D'Sa"", 'Affiliation': 'University College London Hospital Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Krakow, Poland.'}, {'ForeName': 'Hui-Peng', 'Initials': 'HP', 'LastName': 'Lee', 'Affiliation': 'Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Marlton', 'Affiliation': 'Department of Haematology, Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Wahlin', 'Affiliation': 'Unit of Hematology, Department of Medicine, Karolinska Universitetssjukhuset-Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ramón Garcia', 'Initials': 'RG', 'LastName': 'Sanz', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth and Christchurch Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mulligan', 'Affiliation': 'Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Castillo', 'Affiliation': 'Bing Center for Waldenstrom Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Czyz', 'Affiliation': 'Szpital Uniwersytecki No 2 im Dr Jana Biziela, Bydgoszcz, Poland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández de Larrea', 'Affiliation': 'Amyloidosis and Myeloma Unit, Department of Hematology, Hospital Clinic of Barcelona, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Fourth Department of Internal Medicine - Haematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Libby', 'Affiliation': 'Department of Medicine, University of Washington and the Seattle Cancer Care Alliance, Seattle, WA.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Matous', 'Affiliation': 'Colorado Blood Cancer Institute, Denver, CO.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Motta', 'Affiliation': 'ASST Spedali Civili di Brescia, Lombardia, Italy.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Siddiqi', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Ospedale Civile S Maria delle Croci, Azienda Unità Sanitaria Locale (AUSL), Ravenna, Italy.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trneny', 'Affiliation': 'First Department of Medicine, First Faculty of Medicine, Charles University, General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buske', 'Affiliation': 'Comprehensive Cancer Center Ulm-Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': ""Service d'Hématologie Clinique, Sorbonne University, Pitié Salpêtrière Hospital, Paris, France.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': 'Haematology Department, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Wai Y', 'Initials': 'WY', 'LastName': 'Chan', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Ro', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.'}]",Blood,['10.1182/blood.2020006844']
2369,32734378,Cathodal Cerebellar tDCS Combined with Visual Feedback Improves Balance Control.,"Balance control is essential to maintain a stable body position and to prevent falls. The aim of this study was to determine whether balance control could be improved by using cerebellar transcranial direct current stimulation (tDCS) and visual feedback in a combined approach. A total of 90 healthy volunteers were randomly assigned to six groups defined by the delivery of tDCS (cathodal or anodal or sham) and the provision or not of visual feedback on balance during the acquisition phase. tDCS was delivered over the cerebellar hemisphere ipsilateral to the dominant leg for 20 min at 2 mA during a unipedal stance task. Body sway (i.e., ankle angle and hip position) was measured as an overall maximal unit in anteroposterior and mediolateral direction, together with participant rating of perception of stability, before (baseline), during (acquisition), and after (final) the intervention. We found a reduction in body sway during the acquisition session when visual feedback alone was provided. When the visual feedback was removed (final session), however, body sway increased above baseline. Differently, the reduction in overall maximal body sway was maintained during the final session when the delivery of cathodal tDCS and visual feedback was combined. These findings suggest that cathodal tDCS may support the short-term maintenance of the positive effects of visual feedback on balance and provide the basis for a new approach to optimize balance control, with potential translational implications for the elderly and patients with impaired posture control.",2020,The aim of this study was to determine whether balance control could be improved by using cerebellar transcranial direct current stimulation (tDCS) and visual feedback in a combined approach.,"['elderly and patients with impaired posture control', '90 healthy volunteers']","['cerebellar transcranial direct current stimulation (tDCS) and visual feedback', 'Cathodal Cerebellar tDCS Combined with Visual Feedback', 'tDCS', 'cathodal tDCS', 'tDCS (cathodal or anodal or sham) and the provision or not of visual feedback']","['overall maximal body sway', 'body sway', 'Body sway (i.e., ankle angle and hip position']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0561949', 'cui_str': 'Does control posture'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",90.0,0.0253658,The aim of this study was to determine whether balance control could be improved by using cerebellar transcranial direct current stimulation (tDCS) and visual feedback in a combined approach.,"[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Villa-Sánchez', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Raneri', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Dametto', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tinazzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati, 43, 37131, Verona, Italy. mirta.fiorio@univr.it.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01172-0']
2370,32734413,The effect of an educational video on long-acting reversible contraception (LARC) utilization at 6-8 weeks postpartum period: a randomized controlled trial.,"PURPOSE


Long-acting reversible contraception is highly effective in preventing unintended pregnancy and unsafe abortion. An educational video administered during early postpartum period might be an effective tool to improve postpartum LARC use. The objectives were to evaluate whether a postpartum educational video about LARC could increase postpartum LARC utilization at 6-8 weeks postpartum and to assess why postpartum women did not receive LARC.
METHODS


This randomized-controlled trial was conducted at the postpartum unit of a university Hospital between August 2016 and February 2017. Postpartum women who were aged > 20 years and willing to participate were recruited. Participants allocated to the study group watched the 7-min educational video on LARC methods while the control group did not. To assess LARC utilization, data were collected at 6-8 weeks postpartum using telephone calls and/or medical record review to determine postpartum contraception use and reasons for not using LARC.
RESULTS


Two-hundred and seventy participants were enrolled, and the video (135) and non-video (135) groups had similar baseline characteristics. In the video group, 57.8% (95% CI 49.0-66.2) reported using a LARC method, compared to 25.9% (95% CI 18.8-34.2) in the non-video group (p < 0.05). The reasons for not using LARC in both groups were inconvenience of access (42.0-43.8%) and uncertainty about methods (17.0-24.6%).
CONCLUSION


The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum. Inconvenience of access was the most common reason cited for not using LARC.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.in.th TCTR20171225001 ""retrospectively registered"".",2020,The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum.,"['Two-hundred and seventy participants were enrolled, and the video (135) and non-video (135) groups had similar baseline characteristics', 'Postpartum women who were aged\u2009', 'postpartum unit of a university Hospital between August 2016 and February 2017', '20\xa0years and willing to participate were recruited']","['educational video on long-acting reversible contraception (LARC) utilization', 'postpartum educational video about LARC']",['postpartum LARC utilization'],"[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",270.0,0.264079,The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum.,"[{'ForeName': 'Chada', 'Initials': 'C', 'LastName': 'Burapasikarin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand. jittima.man@mahidol.ac.th.'}, {'ForeName': 'Rujira', 'Initials': 'R', 'LastName': 'Wattanayingcharoenchai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05710-3']
2371,32730946,"Domain-specific Involvement of the Right Posterior Parietal Cortex in Attention Network and Attentional Control of ADHD: A Randomized, Cross-over, Sham-controlled tDCS Study.","Transcranial direct current stimulation (tDCS) has been increasingly used in attention-deficit hyperactivity disorder (ADHD) with mixed results. Previous tDCS studies merely targeted the dorsolateral prefrontal cortex and right inferior frontal gyrus with partial or no improving effects on cognitive deficits respectively. Posterior parietal cortex is another region involved in attentional functioning of ADHD, however, its contribution to ADHD attention functions has not been explored in tDCS studies. Moreover, attention networks are not investigated in the previous tDCS studies in ADHD neither. Here, we explored the effects of anodal tDCS over the right posterior parietal cortex (r-PPC) on attentional functioning (i.e., attention networks, selective attention, shifting attention) and response inhibition in ADHD children. 19 children with ADHD were recruited and underwent anodal/sham r-PPC tDCS (1 mA, 20 min) during task performance in a randomized cross-over design. Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations. Furthermore, activation of the r-PPC had a deteriorating effect on the top-down attentional control required for selective attention measured by the Stroop test. Modeling of the current flow showed a stronger electrical field induced in the inferior PPC (BA 39,40) which mediates bottom-up attentional control. No significant effect on shifting attention and response inhibition was found. Our findings indicate a domain-specific involvement of the r-PPC in attention orienting network of ADHD children. Activation of the r-PPC improves bottom-up but hinders top-down attentional control suggesting a critical role of the r-PPC in ADHD bottom-up attentional control.",2020,"Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations.","['ADHD', 'ADHD children', '19 children with ADHD']","['Transcranial direct current stimulation (tDCS', 'anodal tDCS', 'anodal r-PPC tDCS', 'anodal/sham tDCS']","['attentional functioning (attention networks, selective attention, shifting attention', 'shifting attention and response inhibition']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",19.0,0.0442588,"Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations.","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany; Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ghayerin', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran. Electronic address: nejati@sbu.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yavari', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.037']
2372,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
2373,32731011,The effect of Hatha yoga intervention on students' creative ability.,"There is increasing demand for individual creativity as organizations seek innovative ways to remain relevant. Higher education institutions, particularly business schools, are sensitive to this demand and are constantly in search for innovative ways to enhance the creative ability of their students. Prior studies have shown encouraging results for physical activity-oriented interventions. Building on this research, this study uses Randomized Controlled Trial (RCT) to understand if an acute combinatory intervention, involving both physical and mental exercises embodied in Hatha yoga can improve individual creativity. This study uses 92 MBA student participants to investigate the impact of a 20-minute Hatha yoga session intervention against a short 20-minute case study session for the control group. Creative ability of the participants is operationalized through divergent and convergent thinking, which are then assessed through counter-balanced forms of Guilford Alternate Uses tasks and Remote Associate Test, respectively. The results show that while Hatha yoga significantly improves divergent thinking, the control group shows deterioration in divergent thinking. There is no effect on convergent thinking. These findings lend some support to the executive function hypothesis. The study also finds that prodding a person to be more creative on a routine academic task may not enhance their creative ability.",2020,There is no effect on convergent thinking.,"['92 MBA student participants', ""students' creative ability""]",['Hatha yoga intervention'],"['divergent thinking', 'individual creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",92.0,0.0286741,There is no effect on convergent thinking.,"[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bollimbala', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India; T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: ashish@tapmi.edu.in.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'James', 'Affiliation': 'IFIM Business School, Bangalore, Karnataka, India.'}, {'ForeName': 'Shirshendu', 'Initials': 'S', 'LastName': 'Ganguli', 'Affiliation': 'T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: shirshenduganguli@tapmi.edu.in.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103121']
2374,32737350,Effects of combining exercise with long-chain polyunsaturated fatty acid supplementation on cognitive function in the elderly: a randomised controlled trial.,"Multifactorial lifestyle intervention is known to be more effective for ameliorating cognitive decline than single factor intervention; however, the effects of combining exercise with long-chain polyunsaturated fatty acids (LCPUFA) on the elderlies' cognitive function remain unclear. We conducted a randomised, single-masked placebo-controlled trial in non-demented elderly Japanese individuals. Participants were randomly allocated to the exercise with LCPUFA, placebo, or no exercise with placebo (control) groups. Participants in the exercise groups performed 150 min of exercise per week, comprised resistance and aerobic training, for 24 weeks with supplements of either LCPUFA (docosahexaenoic acid, 300 mg/day; eicosapentaenoic acid, 100 mg/day; arachidonic acid, 120 mg/day) or placebo. Cognitive functions were evaluated by neuropsychological tests prior to and following the intervention. The per-protocol set analysis (n = 76) revealed no significant differences between the exercise and the control groups in changes of neuropsychological tests. Subgroup analysis for participants with low skeletal muscle mass index (SMI) corresponding to sarcopenia cut-off value showed changes in selective attention, while working memory in the exercise with LCPUFA group was better than in the control group. These findings suggest that exercise with LCPUFA supplementation potentially improves attention and working memory in the elderly with low SMI.",2020,The per-protocol set analysis (n = 76) revealed no significant differences between the exercise and the control groups in changes of neuropsychological tests.,"['elderly', 'non-demented elderly Japanese individuals', 'elderly with low SMI']","['exercise with LCPUFA, placebo, or no exercise with placebo (control', 'Multifactorial lifestyle intervention', '150\xa0min of exercise per week, comprised resistance and aerobic training', 'LCPUFA (docosahexaenoic acid, 300\xa0mg/day; eicosapentaenoic acid, 100\xa0mg/day; arachidonic acid, 120\xa0mg/day) or placebo', 'combining exercise with long-chain polyunsaturated fatty acids (LCPUFA', 'combining exercise with long-chain polyunsaturated fatty acid supplementation', 'LCPUFA supplementation', 'placebo']","['neuropsychological tests', 'Cognitive functions', 'cognitive function', 'attention and working memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.127031,The per-protocol set analysis (n = 76) revealed no significant differences between the exercise and the control groups in changes of neuropsychological tests.,"[{'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Tokuda', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan. Hisanori_Tokuda@suntory.co.jp.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Safety Science Institute, Suntory MONOZUKURI Expert Ltd., Kyoto, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Sueyasu', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kaneda', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Rogi', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Medical Corporation Kenshokai, Fukushima Healthcare Center, Osaka, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Kouzaki', 'Affiliation': 'Laboratory of Neurophysiology, Graduate School of Human and Environmental Studies, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsukiura', 'Affiliation': 'Department of Cognitive and Behavioral Sciences, Graduate School of Human and Environmental Studies, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}]",Scientific reports,['10.1038/s41598-020-69560-4']
2375,32737973,Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers.,"OBJECTIVE


To fulfill the potential of nonpharmacological interventions for people with Parkinson disease (PD), individually tailored treatment is needed. Multimodal balance training supported by rhythmic auditory stimuli (RAS) can improve balance and gait in people with PD. The purpose of this study was to determine whether both freezers and nonfreezers benefit.
METHODS


A secondary analysis was conducted on a large randomized controlled trial that included 154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication) who were assigned randomly to 3 groups: (1) multimodal balance training with RAS delivered by a metronome (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmic auditory cues; and (3) a control intervention (involving an educational program). Training was performed for 5 weeks, twice per week. The primary outcome was the Mini-BESTest score directly after the training period. Assessments were performed by a single, masked assessor at baseline, directly postintervention, and after 1-month and 6-month follow-up. Outcomes were analyzed in 1 analysis, and the results were presented separately for freezers and nonfreezers with a linear mixed model, adjusted for baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose.
RESULTS


In both freezers and nonfreezers, both RAS-supported multimodal training and regular training significantly improved the Mini-BESTest scores compared with baseline scores and with the control group scores. The improvement was larger for RAS-supported training compared with regular training, for both freezers and nonfreezers. Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
CONCLUSIONS


RAS-supported multimodal training is effective in improving balance performance in both freezers and nonfreezers.
IMPACT


Until this study, it was unknown whether both freezers and nonfreezers could benefit from multimodal balance training. With this information, clinicians who work with people with PD will be better able to apply personalized gait rehabilitation.
LAY SUMMARY


Adding rhythmic auditory stimuli (RAS) to balance training is beneficial for both freezers and nonfreezers, at least in persons with mild to moderate disease stages. This RAS-supported multimodal training has good potential for a wider clinical implementation with good long-term effects.",2020,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","['154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication', 'Parkinson Disease', 'Parkinson disease (PD']","['multimodal balance training with rhythmic auditory stimuli delivered by a metronome (RAS-supported multimodal balance training), (2) regular multimodal balance training without rhythmic auditory cues, and (3) a control intervention (involving an educational program', 'Multimodal balance training', 'Multimodal Balance Training', 'RAS-supported multimodal training']","['Mini-BESTest scores', 'balance performance', 'Mini-BESTest score directly', ""baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose"", 'balance and gait in PD']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]",154.0,0.0633119,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; Nijmegen, the Netherlands; and Movement Disorders Clinic, Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Jordache', 'Initials': 'J', 'LastName': 'Ramjith', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, University of São Paulo.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; and Department of Rehabilitation, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa146']
2376,32736216,Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial.,"BACKGROUND


Cognitive impairment is common in patients with multiple sclerosis (MS). The effects of different exercise trainings on cognitive functions in patients with MS are promising. However, the effects are not yet clear in MS patients with cognitive impairment. This study aimed to investigate the effect of combined exercise training on different cognitive functions in MS patients with cognitive impairment.
METHODS


Relapsing-remitting and mild disabled MS patients with cognitive impairment were randomly assigned to two groups: Exercise Group (EG, n:17) and the Control Group (CG, n:17). The EG received a combined exercise training consisting of aerobic and Pilates training in three sessions per week for 8 weeks while the CG performed the relaxation exercises at home. Cognitive functions, walking capacity, fatigue, mood, and quality of life were assessed at baseline and after eight weeks using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively.
RESULTS


This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003). Moreover, verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory increased in the CG (p<0.05). Furthermore, the change in visuospatial memory was associated with the change in mental quality of life (r:0.352, p: 0.041) while the change in verbal fluency (r: -0.362, p:0.035) and processing speed (r: -0.356, p:0.039) were associated with the change in mood.
CONCLUSION


Combined exercise training has beneficial effects on different cognitive functions in mild disabled RRMS patients with cognitive impairment. In addition, there is a mutual relationship in improvements in cognitive functions, mood, and quality of life after exercise.",2020,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","['mild disabled RRMS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment', 'patients with MS', 'Relapsing-remitting and mild disabled MS patients with cognitive impairment', 'patients with multiple sclerosis (MS', 'MS patients with cognitive impairment']","['Combined exercise training', 'combined exercise training consisting of aerobic and Pilates training', 'exercise trainings', 'Exercise Group (EG, n:17) and the Control Group (CG, n:17', 'combined exercise training']","['change in visuospatial memory', 'verbal fluency', 'long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life', 'processing speed', 'Cognitive functions, walking capacity, fatigue, mood, and quality of life', 'cognitive functions', ""Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively"", 'verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory', 'mental quality of life', 'cognitive functions, mood, and quality of life']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0502248,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: caglaozkul@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102419']
2377,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
2378,32741829,Music Playlists for People with Dementia: Trialing A Guide for Caregivers.,"BACKGROUND


Music programs have the potential to provide an effective non-pharmacological tool for caregivers to reduce depression and agitation and increase quality of life in people with dementia. However, where such programs are not facilitated by a trained music therapist, caregivers need greater access to information about how to use music most effectively in response to key challenges to care, and how to pre-empt and manage adverse responses.
OBJECTIVE


This study reports on the trial of a Guide for use of music with 45 people with dementia and their caregivers in residential care facilities and home-based care.
METHODS


The study used a pre-post experimental design in which participants were randomly allocated to a treatment group or a waitlist control group.
RESULTS


Improvements to quality of life were found in the experimental group over the 6-week period. Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
CONCLUSION


The Guide can provide an effective protocol for caregivers to follow in selecting music to manage particular challenges to care, confirming the need for caregivers to be prepared to monitor and manage potential negative responses.",2020,"Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
","['45 people with dementia and their caregivers in residential care facilities and home-based care', 'People with Dementia', 'people with dementia']","['Music Playlists', 'waitlist control group']","['quality of life', 'Interest, Responsiveness, Initiation, Involvement, and Enjoyment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",45.0,0.0631866,"Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garrido', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dunne', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'School of Nursing & Midwifery, Western Sydney University, Penrith, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200457']
2379,32744599,Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial.,"Importance


Urinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear.
Objective


To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.
Design, Setting, and Participants


The Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled.
Interventions


After an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184).
Main Outcomes and Measures


The primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used.
Results


Among 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon.
Conclusions and Relevance


Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability.
Trial Registration


ClinicalTrials.gov Identifier: NCT02039830.",2020,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","['older women', 'Older Women', '362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis', 'older women (aged ≥60 years', '2 Canadian research centers, from July 1, 2012, to June 2, 2018', '362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled']","['Individual pelvic floor muscle training (PFMT', 'Individual Pelvic Floor Muscle Training', 'Group Rehabilitation or Individual Physiotherapy (GROUP', 'Individual PFMT and group-based PFMT', 'group-based PFMT relative to individual PFMT']","['percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline', 'Adverse events', 'urinary incontinence episodes', 'lower urinary tract-related signs, symptoms, and quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",362.0,0.140746,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","[{'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Danieli', 'Affiliation': 'Research Institute of the McGill University Health Center, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Cacciari', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Department of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University and Research Institute of the McGill University Health Center, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2993']
2380,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
2381,32744134,A Simple Goal Elicitation Tool Improves Shared Decision Making in Outpatient Orthopedic Surgery: A Randomized Controlled Trial.,"Introduction . Shared decision making involves educating the patient, eliciting their goals, and collaborating on a decision for treatment. Goal elicitation is challenging for physicians as previous research has shown that patients do not bring up their goals on their own. Failure to properly elicit patient goals leads to increased patient misconceptions and decisional conflict. We performed a randomized controlled trial to test the efficacy of a simple goal elicitation tool in improving patient involvement in decision making.  Methods . We conducted a randomized, single-blind study of new patients presenting to a single, outpatient surgical center. Prior to their consultation, the intervention group received a demographics questionnaire and a goal elicitation worksheet. The control group received a demographics questionnaire only. After the consultation, both groups were asked to complete the Perceived Involvement in Care Scale (PICS) survey. We compared the mean PICS scores for the intervention and control groups using a nonparametric Mann-Whitney Wilcoxon test. Secondary analysis included a qualitative content analysis of the patient goals.  Results . Our final cohort consisted of 96 patients (46 intervention, 50 control). Both groups were similar in terms of demographic composition. The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01). Thirty-nine percent of patient goals were focused on receiving a diagnosis or treatment, while 21% of patients wanted to receive education regarding their illness or their treatment options.  Discussion . A single-step goal elicitation tool was effective in improving patient-perceived involvement in their care. This tool can be efficiently implemented in both academic and nonacademic settings.",2020,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01).","['96 patients (46 intervention, 50 control', 'Outpatient Orthopedic Surgery', 'new patients presenting to a single, outpatient surgical center']","['demographics questionnaire and a goal elicitation worksheet', 'demographics questionnaire only']","['mean PICS scores', 'qualitative content analysis of the patient goals', 'mean (SD) PICS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroidopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",96.0,0.0671466,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mertz', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Romil F', 'Initials': 'RF', 'LastName': 'Shah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Safran', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Palanca', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Serena S', 'Initials': 'SS', 'LastName': 'Hu', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gardner', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Derek F', 'Initials': 'DF', 'LastName': 'Amanatullah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20943520']
2382,32744184,Pregnancy outcomes among women born in Somalia and Sweden giving birth in the Stockholm area - a population-based study.,"BACKGROUND


Studies report that women born in some African countries, after migrating to the Nordic countries, have worse pregnancy outcomes than women born in the receiving countries. With the aim of identifying unmet needs among Somali-born women, we here study this subgroup.
OBJECTIVE


We compared pregnancy outcomes among women born in Somalia to women born in Sweden. Further, we investigated whether the proactive maternal observation of fetal movements has effects on birth outcomes among women born in Somalia.
METHODS


In Stockholm, half of the maternity clinics were randomized to intervention, in which midwives were instructed to be proactive towards women by promoting daily self-monitoring of fetal movements. Data for 623 women born in Somalia and 26 485 born in Sweden were collected from a population-based register.
RESULTS


An Apgar score below 7 (with stillbirth counting as 0) at 5 minutes was more frequent in babies of women born in Somalia as compared to babies of women born in Sweden (RR 2.17, 95% CI 1.25-3.77). Babies born small for gestational age were more common among women born in Somalia (RR 2.22, CI 1.88-2.61), as were babies born after 41 + 6 gestational weeks (RR 1.65, CI 1.29-2.12). Somali-born women less often contacted obstetric care for decreased fetal movements than did Swedish-born women (RR 0.19, CI 0.08-0.36). The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
CONCLUSIONS


A higher risk of a negative outcome for mother and baby is seen among women born in Somalia compared to women born in Sweden. We suggest it may be worthwhile to investigate whether a Somali-adapted intervention with proactivity concerning self-monitoring of fetal movements may improve pregnancy outcomes in this migrant population.",2020,"The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
","['women born in Somalia and Sweden giving birth in the Stockholm area - a population-based study', '623 women born in Somalia and 26 485 born in Sweden were collected from a population-based register', 'women born in Somalia', 'women born in Somalia to women born in Sweden', 'women born in Somalia compared to women born in Sweden', 'Somali-born women', 'women born in some African countries']",['proactive towards women by promoting daily self-monitoring of fetal movements'],"['Pregnancy outcomes', 'Apgar score', 'fetal movements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1277513', 'cui_str': 'Born in Somalia'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1277386', 'cui_str': 'Born in Sweden'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0337847', 'cui_str': 'Somalis'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0454695', 'cui_str': 'African country'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015946', 'cui_str': 'Fetal movement activity'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015946', 'cui_str': 'Fetal movement activity'}]",,0.0919175,"The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Akselsson', 'Affiliation': 'Department of Health Promoting Science, Sophiahemmet University , Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet , Stockholm, Sweden.""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Georgsson', 'Affiliation': 'The Swedish Red Cross University College , Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet , Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Skokic', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Gothenburg, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Rådestad', 'Affiliation': 'Department of Health Promoting Science, Sophiahemmet University , Stockholm, Sweden.'}]",Global health action,['10.1080/16549716.2020.1794107']
2383,32739846,Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: A randomized double-blind trial.,"BACKGROUND


This study aimed to compare the analgesic efficacy of topical capsaicin and topical piroxicam in acute musculoskeletal injuries.
METHODS


This is a prospective, randomized, controlled, double-blinded study. The data for the 67 patients in the piroxicam group and the 69 in the capsaicin group were examined. The initial visual analog scale (VAS) scores were compared with the 60th and 120th minute as well as the 24th and 72nd hour values. Differences between the VAS scores, clinical effectiveness of the treatment and side effects were evaluated.
RESULTS


In the capsaicin group, the mean difference in the delta VAS scores was significantly higher at each measurement time. The mean of the percentage of reduction in the VAS scores of the topical capsaicin group was significantly higher than that in the topical piroxicam group. The highest difference in terms of both outcomes was determined at the 72nd hour VAS change. Mean differences were 1.53 (95% CI: 0.85-2.221) and 19.7 (95% CI: 12.4-27.2) respectively (p < 0.001). In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01). The difference between the clinical effectiveness of the groups regarding the treatment outcomes was also statistically significant (p < 0.001). There was no significant difference between the patient groups regarding the presence of side effects.
CONCLUSION


Topical capsaicin can be used as an alternative to topical piroxicam initially and at follow-up in patients presenting to the emergency department with acute pain as there were no observable differences in side-effects between the two groups.",2020,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","['patients presenting to the emergency department with acute pain', 'acute musculoskeletal injuries', 'acute trauma-induced pain', '67 patients in the']","['topical capsaicin', 'topical capsaicin and topical piroxicam', 'piroxicam', 'capsaicin', 'Topical capsaicin', 'topical piroxicam']","['VAS scores, clinical effectiveness of the treatment and side effects', 'side effects', 'delta VAS scores', 'analgesic efficacy', 'initial visual analog scale (VAS) scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0861012,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","[{'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: abdullahmrym86@gmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Familiy Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Cekmen', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Orun', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Namik Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.05.104']
2384,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
2385,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
2386,32740891,A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease.,"BACKGROUND


Because of their well-described immunosuppressive properties, allogeneic adult human mesenchymal stromal cells (MSC) derived from bone marrow have demonstrated safety and efficacy in steroid refractory acute graft versus host disease (SR aGVHD). Clinical trials have resulted in variable success and an optimal source of MSC has yet to be defined. Based on the importance of maternal-fetal interface immune tolerance, extraembryonic fetal tissues, such as the umbilical cord, may provide an superior tissue source of MSC to mediate immunomodulation in aGVHD.
METHODS


A two-dose cohort trial allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC, referred to as MSCTC-0010, here) were tested in 10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT). Following Good Manufacturing Practices isolation, expansion and cryostorage, WJMSC were thawed and administered via intravenous infusions on days 0 and 7 at one of two doses (low dose cohort, 2 × 10 6 /kg, n = 5; high dose cohort, 10 × 10 6 /kg, n = 5). To evaluate safety, patients were monitored for infusion related toxicity, Treatment Related Adverse Events (TRAE) til day 42, or ectopic tissue formation at day 90. Clinical responses were monitored at time points up to 180 days post infusion. Serum biomarkers ST2 and REG3α were acquired 1 day prior to first MSCTC-0010 infusion and on day 14.
RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed. Clinical response was suggested at day 28: the overall response rate (ORR) was 70%, 4 of 10 patients had a complete response (CR) and 3 had a partial response (PR). By study day 90, the addition of escalated immunosuppressive therapy was necessary in 2 of 9 surviving patients. Day 100 and 180 post infusion survival was 90% and 60%, respectively. Serum biomarker REG3α decreased, particularly in the high dose cohort, and with REG3α decrease correlated with clinical response.
CONCLUSIONS


Treatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 10 6  cells/ kg dose be tested in an expanded randomized, controlled Phase 2 trial. Graphical abstract.",2020,"RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.",['10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT'],"[""Wharton's Jelly-Derived Mesenchymal Stromal Cells"", ""allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC"", 'MSCTC-0010']","['Serum biomarkers', 'Adverse Events (TRAE) til day 42, or ectopic tissue formation', 'overall response rate (ORR', 'Serum biomarker REG3α', 'partial response (PR', 'tolerated, and no TRAEs or ectopic tissue formation', 'no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008519', 'cui_str': 'Ectopic tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",10.0,0.118327,"RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.","[{'ForeName': 'Rupal P', 'Initials': 'RP', 'LastName': 'Soder', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Buddhadeb', 'Initials': 'B', 'LastName': 'Dawn', 'Affiliation': 'University of Nevada, Las Vegas School of Medicine, Las Vegas, NV, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Weiss', 'Affiliation': 'Midwest Institute of Comparative Stem Cell Biotechnology and Department of Anatomy and Physiology, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Dunavin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Institute for Advancing Medical Innovation Medical Center, University of Kansas, Kansas City, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Meizhang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Shune', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Abdelhakim', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Abhyankar', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGuirk', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA. jmcguirk@kumc.edu.'}]",Stem cell reviews and reports,['10.1007/s12015-020-10015-8']
2387,32739184,Re: Ang et al.: Randomized clinical trial comparing femtosecond LASIK and small-incision lenticule extraction (Ophthalmology. 2020;127:724-730).,,2020,,[],['femtosecond LASIK and small-incision lenticule extraction'],[],[],"[{'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],,0.0877184,,"[{'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Wallerstein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada. Electronic address: awallerstein@lasikmd.com.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gauvin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.032']
2388,32757302,A randomized phase 2 trial of pembrolizumab versus pembrolizumab and acalabrutinib in patients with platinum-resistant metastatic urothelial cancer.,"BACKGROUND


Inhibition of the programmed cell death protein 1 (PD-1) pathway has demonstrated clinical benefit in metastatic urothelial cancer (mUC); however, response rates of 15% to 26% highlight the need for more effective therapies. Bruton tyrosine kinase (BTK) inhibition may suppress myeloid-derived suppressor cells (MDSCs) and improve T-cell activation.
METHODS


The Randomized Phase 2 Trial of Acalabrutinib and Pembrolizumab Immunotherapy Dual Checkpoint Inhibition in Platinum-Resistant Metastatic Urothelial Carcinoma (RAPID CHECK; also known as ACE-ST-005) was a randomized phase 2 trial evaluating the PD-1 inhibitor pembrolizumab with or without the BTK inhibitor acalabrutinib for patients with platinum-refractory mUC. The primary objectives were safety and objective response rates (ORRs) according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Immune profiling was performed to analyze circulating monocytic MDSCs and T cells.
RESULTS


Seventy-five patients were treated with pembrolizumab (n = 35) or pembrolizumab plus acalabrutinib (n = 40). The ORR was 26% with pembrolizumab (9% with a complete response [CR]) and 20% with pembrolizumab plus acalabrutinib (10% with a CR). The grade 3/4 adverse events (AEs) that occurred in ≥15% of the patients were anemia (20%) with pembrolizumab and fatigue (23%), increased alanine aminotransferase (23%), urinary tract infections (18%), and anemia (18%) with pembrolizumab plus acalabrutinib. One patient treated with pembrolizumab plus acalabrutinib had high MDSCs at the baseline, which significantly decreased at week 7. Overall, MDSCs were not correlated with a clinical response, but some subsets of CD8+ T cells did increase during the combination treatment.
CONCLUSIONS


Both treatments were generally well tolerated, although serious AE rates were higher with the combination. Acalabrutinib plus pembrolizumab did not improve the ORR, PFS, or OS in comparison with pembrolizumab alone in mUC. Baseline and on-treatment peripheral monocytic MDSCs were not different in the treatment cohorts. Proliferating CD8+ T-cell subsets increased during treatment, particularly in the combination cohort. Ongoing studies are correlating these peripheral immunome findings with tissue-based immune cell infiltration.",2020,"Acalabrutinib plus pembrolizumab did not improve the ORR, PFS, or OS in comparison with pembrolizumab alone in mUC.","['Platinum-Resistant Metastatic Urothelial Carcinoma (RAPID CHECK', 'Seventy-five patients were treated with', 'patients with platinum-resistant metastatic urothelial cancer', 'patients with platinum-refractory mUC', 'metastatic urothelial cancer (mUC']","['Acalabrutinib and Pembrolizumab Immunotherapy Dual Checkpoint Inhibition', 'pembrolizumab and acalabrutinib', 'Acalabrutinib plus pembrolizumab', 'pembrolizumab plus acalabrutinib', 'pembrolizumab']","['urinary tract infections', 'progression-free survival (PFS) and overall survival (OS', 'circulating monocytic MDSCs and T cells', 'safety and objective response rates (ORRs', 'grade 3/4 adverse events (AEs', 'serious AE rates', 'ORR, PFS, or OS', 'alanine aminotransferase', 'ORR', 'Proliferating CD8+ T-cell subsets', 'anemia', 'CD8+ T cells']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C4277543', 'cui_str': 'MDSCs'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",75.0,0.101506,"Acalabrutinib plus pembrolizumab did not improve the ORR, PFS, or OS in comparison with pembrolizumab alone in mUC.","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Duke Cancer Institute, Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Duke Cancer Institute, Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': ""O'Donnell"", 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ajjai S', 'Initials': 'AS', 'LastName': 'Alva', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, Michigan.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Hahn', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Leonard J', 'Initials': 'LJ', 'LastName': 'Appleman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cetnar', 'Affiliation': 'Oregon Health and Science University Center for Health, Portland, Oregon.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Burke', 'Affiliation': 'Rocky Mountain Cancer Centers, Aurora, Colorado.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fleming', 'Affiliation': 'Virginia Oncology Associates, Norfolk, Virginia.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Milowsky', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mortazavi', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, South Carolina.'}, {'ForeName': 'Guru P', 'Initials': 'GP', 'LastName': 'Sonpavde', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Merck & Co, Inc, North Wales, Pennsylvania.'}, {'ForeName': 'Bojena', 'Initials': 'B', 'LastName': 'Bitman', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, California.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, California.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, California.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, California.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Staats', 'Affiliation': 'Division of Surgical Sciences, Department of Surgery, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Cliburn', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kent J', 'Initials': 'KJ', 'LastName': 'Weinhold', 'Affiliation': 'Division of Surgical Sciences, Department of Surgery, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke Cancer Institute, Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}]",Cancer,['10.1002/cncr.33067']
2389,32748303,Kinematic and Somatosensory Gains in Infants with Cerebral Palsy After a Multi-Component Upper-Extremity Intervention: A Randomized Controlled Trial.,"Upper extremity (UE) impairments in infants with cerebral palsy (CP) result from reduced quality of motor experiences and ""noisy"" sensory inputs. We hypothesized that a neuroscience-based multi-component intervention would improve somatosensory processing and motor measures of more-affected (UEs) in infants with CP and asymmetric UE neurologic impairments, while remaining safe for less-affected UEs. Our randomized controlled trial compared infants (6-24 months) with CP receiving intervention (N = 37) versus a waitlisted group (N = 36). Treatment effects tested a direct measurement of reach smoothness (3D-kinematics), a measure of unimanual fine motor function (Bayley unimanual fine motor raw scores), and EEG measures of cortical somatosensory processing. The four-week therapist-directed, parent-administered intervention included daily (1) bimanual play; (2) less-affected UE wearing soft-constraint (6 h/day, electronically-monitored); (3) reach training on more-affected UE; (4) graduated motor-sensory training; and (5) parent education. Waitlist infants received only bimanual play. Effectiveness and safety were tested; z-scores from 54 posttest-matched typically-developing infants provided benchmarks for treatment effects. Intervention and waitlist infants had no pretest differences. Median weekly constraint wear was 38 h; parent-treatment fidelity averaged > 92%. On the more affected side, the intervention significantly increased smoothness of reach (Cohen's d = - 0.90; p < .001) and unimanual fine motor skill (d = 0.35; p = .004). Using unadjusted p values, intervention improved somatosensory processing (d = 0.53; p = .04). All intervention effects referenced well to typically developing children. Safety of the intervention was demonstrated through positive- or non-effects on measurements involving the constrained, less-affected UE and gross motor function; unexpected treatment effects on reach smoothness occurred in less-affected UEs (d =  - 0.85; p = .01). This large clinical trial demonstrated intervention effectiveness and safety for developing sensory and motor systems with improvements in reach smoothness, and developmental abilities.Clinical Trail Registration: ClinicalTrials.gov NCT02567630, registered October 5, 2015.",2020,"On the more affected side, the intervention significantly increased smoothness of reach (Cohen's d = - 0.90; p < .001) and unimanual fine motor skill (d = 0.35; p = .004).","['Infants with Cerebral Palsy', 'infants with cerebral palsy (CP', 'infants with CP and asymmetric UE neurologic impairments', 'infants (6-24\xa0months) with CP receiving intervention (N\u2009=\u200937) versus a waitlisted group (N\u2009=\u200936']","['bimanual play', 'neuroscience-based multi-component intervention', 'parent-administered intervention included daily (1) bimanual play; (2) less-affected UE wearing soft-constraint (6\xa0h/day, electronically-monitored); (3) reach training on more-affected UE; (4) graduated motor-sensory training; and (5) parent education', 'Multi-Component Upper-Extremity Intervention']","['unimanual fine motor function (Bayley unimanual fine motor raw scores), and EEG measures of cortical somatosensory processing', 'reach smoothness', 'somatosensory processing and motor measures', 'Kinematic and Somatosensory Gains', 'unimanual fine motor skill', 'somatosensory processing', 'Effectiveness and safety', 'Upper extremity (UE) impairments', 'smoothness of reach']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0562229', 'cui_str': 'Fine motor functions'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0602155,"On the more affected side, the intervention significantly increased smoothness of reach (Cohen's d = - 0.90; p < .001) and unimanual fine motor skill (d = 0.35; p = .004).","[{'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA. Nathalie.maitre@nationwidechildrens.org.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jeanvoine', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Yoder', 'Affiliation': 'Department of Special Education, Peabody College of Education and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Key', 'Affiliation': 'Department of Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Carey', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Needham', 'Affiliation': 'Department of Psychology and Human Development, Peabody College, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Micah M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': 'Department of Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Heathcock', 'Affiliation': 'School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Brain topography,['10.1007/s10548-020-00790-5']
2390,32746775,Efficacy and safety of erenumab in women with a history of menstrual migraine.,"BACKGROUND


We performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.
METHODS


Patients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.
RESULTS


Among 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on ""migraine days"" includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively. The odds of having a ≥ 50% reduction from baseline in MMD over months 4-6 were 2.2 (P = 0.024) and 2.8 (P = 0.002) times greater for erenumab 70 mg and 140 mg, respectively, than for placebo. Erenumab had an overall safety profile comparable to placebo.
CONCLUSION


Data from this subgroup analysis of women with menstrual migraine are consistent with data from the overall STRIVE episodic migraine population, supporting the efficacy and safety of erenumab in women who experience menstrual migraine.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02456740. Registered 28 May 2015.",2020,"Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively.","['women with menstrual migraine', 'Women who reported history of menstrual migraine and who were\u2009≤\u200950\u2009years old were included in the analysis', '814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were\u2009≤\u200950\u2009years old', 'women with a history of menstrual migraine', 'women with self-reported menstrual migraine', 'women who experience menstrual migraine']","['erenumab', 'placebo, erenumab 70\u2009mg, or erenumab 140\u2009mg subcutaneously', 'placebo']","['overall safety profile', 'Efficacy and safety', 'monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0269226', 'cui_str': 'Menstrual migraine'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",814.0,0.544437,"Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively.","[{'ForeName': 'Jelena M', 'Initials': 'JM', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology, Montefiore Headache Center, 1300 Morris Park Avenue, Van Etten 3C9, Bronx, NY, 10461, USA. jpavlovi@montefiore.org.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Paemeleire', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Göbel', 'Affiliation': 'Kiel Migraine and Headache Center, Kiel, Germany.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology, St Louis, MO, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rapoport', 'Affiliation': 'The David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Kagan', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01167-6']
2391,32756067,Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study.,"Cognitive training (CT) shows modest positive effects on cognitive function in patients with Parkinson's disease (PD). Gamification may enhance adherence to traditional CT, but this has not been studied yet. Here, we investigated the feasibility of a gamified CT. We performed a randomized controlled trial including PD patients with mild cognitive impairment. Participants were randomly allocated to a 12-week home-based gamified CT intervention or waiting-list control group. Assessments were performed at baseline and at weeks 12 and 24. Forty-one patients were included (21 intervention and 20 waiting-list controls). Sixty-three percent of the intervention group trained >50% of the recommended sessions, while 81% voluntarily continued training after 12 weeks. After 24 weeks, 87.5% graded the game to be satisfactory. Global cognition scores improved after 24 weeks. Home-based gamified CT shows acceptable feasibility in patients with PD, and we observed preliminary indications for efficacy. Larger trials are needed to establish this efficacy.",2020,Global cognition scores improved after 24 weeks.,"[""patients with Parkinson's disease (PD"", ""Parkinson's Disease"", 'PD patients with mild cognitive impairment', 'patients with PD', 'Forty-one patients were included (21 intervention and 20 waiting-list controls']","['gamified CT', 'Cognitive Training Game', '12-week home-based gamified CT intervention or waiting-list control group', 'Cognitive training (CT']","['cognitive function', 'Global cognition scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0472378,Global cognition scores improved after 24 weeks.,"[{'ForeName': 'Sjors C F', 'Initials': 'SCF', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands, sjors.vande.weijer@mumc.nl.'}, {'ForeName': 'Annelien A', 'Initials': 'AA', 'LastName': 'Duits', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': 'School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Tissingh', 'Affiliation': 'Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Kuijf', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",European neurology,['10.1159/000509685']
2392,32745768,Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.,"Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F 2t -isoprostanes (F 2t -IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).",2020,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","['healthy adults and macrophage derived foam cells', 'healthy subjects']",['CGAs'],"['levels of oxLDL', 'IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0016390', 'cui_str': 'Foam cell'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0055633', 'cui_str': 'Chromogranin A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0588372,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Lara-Guzmán', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Grupo de Investigación en Sustancias Bioactivas, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Oger', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Durand', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Galano', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zuluaga', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain. Electronic address: angelgil@cebas.csic.es.'}, {'ForeName': 'Katalina', 'Initials': 'K', 'LastName': 'Muñoz-Durango', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia. Electronic address: kmunoz@serviciosnutresa.com.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.07.020']
2393,32744859,The role of health anxiety in the experience of perceived stress across the menstrual cycle.,"Background:  Hormonal variation throughout the menstrual cycle influences physiological and psychological symptoms, although not for all women. Individual differences in health anxiety (HA) might help to explain the differences in physiological and psychological symptoms and perceived stress observed across women.  Design:  We examined the moderating role of HA in the relation between menstrual phase and premenstrual symptom severity and perceived stress.  Methods:  A total of 38 women completed visits in both late luteal and follicular phases, with visit order randomized. Menstrual phase was verified using day-count, a luteinizing hormone test, and progesterone assay.  Results:  Linear mixed models revealed that women experienced more premenstrual symptoms during the late luteal phase vs. the follicular phase; however, HA did not moderate this effect. There was a significant HA × menstrual cycle phase interaction for perceived stress. During the late luteal phase, women with higher HA reported greater perceived stress compared to women with lower HA. In the follicular phase, women with higher and lower HA reported similar levels of perceived stress.  Conclusion:  Higher levels of HA may play a role in the experience of perceived stress in specific phases of the menstrual cycle.",2020,There was a significant HA × menstrual cycle phase interaction for perceived stress.,"['38 women completed visits in both late luteal and follicular phases, with visit order randomized']",[],"['health anxiety (HA', 'premenstrual symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}]",38.0,0.0325567,There was a significant HA × menstrual cycle phase interaction for perceived stress.,"[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Shayani', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Arditte Hall', 'Affiliation': 'Department of Psychology & Philosophy, Framingham State University.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Isley', 'Affiliation': 'College of Science, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Rohan', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Y I', 'Initials': 'YI', 'LastName': 'Nillni', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1802434']
2394,32753268,Differences in Thromboembolic Complications Between Paroxysmal and Persistent Atrial Fibrillation Patients Following Electrical Cardioversion (From the ENSURE-AF Study).,"It is unclear if patients with paroxysmal atrial fibrillation (AF) and persistent AF have different outcomes following electrical cardioversion (ECV). ENSURE-AF-a multicenter, prospective, randomized, open-label, blinded-endpoint evaluation trial-compared once-daily edoxaban 60 mg with enoxaparin-warfarin in 2,199 subjects undergoing ECV of nonvalvular AF (NCT02072434). Patients received ≥3 weeks of proper anticoagulation or transesophageal echocardiogram before ECV paroxysmal AF was defined as AF with spontaneous conversion of duration of <7 days; persistent AF was defined as AF lasting ≥7 days without spontaneous conversion. Clinical characteristics and outcomes were compared between subjects based on type of AF present at baseline. In total, 415 subjects had paroxysmal AF; 1,777 had persistent AF. Patients with paroxysmal AF were older (65.8 ± 10.3 vs 63.9 ± 10.5, p = 0.001) with more hypertension (82.7% vs 77.2%, p = 0.01) versus persistent AF patients. Congestive heart failure was more common in persistent AF (46.7%) versus paroxysmal AF (31.3%, p <0.0001). CHA 2 DS 2 -VASc (score >2: 52.0% vs 49.5%, p = 0.4375) and prior myocardial infarction (6.5% vs 6.8%, p = 0.91) did not significantly differ between groups. After ECV, primary endpoint events were numerically higher in paroxysmal AF versus persistent AF (1.5% vs 0.6%, p = 0.0571), approaching statistical significance. Of note, myocardial infarction was observed in paroxysmal AF (n = 4 vs 0), whereas persistent AF was accompanied by stroke (n = 0 vs 5; p <0.05). In conclusion, patients with paroxysmal AF had more frequent major cardiovascular events than patients with persistent AF. Composite event rates were driven mainly by myocardial infarction in patients with paroxysmal AF and by stroke in those with persistent AF. Overall, the absolute number of events was low after ECV under anticoagulation.",2020,"(score >2: 52.0% vs 49.5%, p = 0.4375) and prior myocardial infarction (6.5% vs 6.8%, p = 0.91) did not significantly differ between groups.","['2,199 subjects undergoing ECV of nonvalvular AF (NCT02072434', '415 subjects had paroxysmal AF; 1,777 had persistent AF', 'patients with paroxysmal atrial fibrillation (AF']","['electrical cardioversion (ECV', 'edoxaban', 'enoxaparin-warfarin', 'Electrical Cardioversion']","['paroxysmal AF', 'CHA 2 DS 2 -VASc', 'paroxysmal AF versus persistent AF', 'Congestive heart failure', 'prior myocardial infarction', 'myocardial infarction', 'Thromboembolic Complications', 'frequent major cardiovascular events', 'Composite event rates', 'hypertension']","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",2199.0,0.0283141,"(score >2: 52.0% vs 49.5%, p = 0.4375) and prior myocardial infarction (6.5% vs 6.8%, p = 0.91) did not significantly differ between groups.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'St. Vincenz-Hospital, Paderborn, Germany; Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany. Electronic address: andreas.goette@vincenz.de.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, New Jersey.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbuchel', 'Affiliation': 'Antwerp University and University Hospital, Cardiology, Antwerp, Belgium.'}, {'ForeName': 'Aron-Ariel', 'Initials': 'AA', 'LastName': 'Cohen', 'Affiliation': 'Hôpital Saint Antoine, Hôpital Tenon, Paris, France; Université Pierre et Marie Curie (Paris VI), Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ezekowitz', 'Affiliation': 'Department of Cardiovascular Medicine, Sidney Kimmel Jefferson Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania; Lankenau Medical Center, Broomall, Pennsylvania.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Arrhythmia and Robotic Electrophysiology Unit, Hospital Universitario La Paz, Universidad Europea, Madrid, Spain.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.046']
2395,32753300,Bariatric surgery in the elderly: a randomized prospective study comparing safety of sleeve gastrectomy and Roux-en-Y gastric bypass (BASE Trial).,"BACKGROUND


The aging population along with the obesity epidemic has increased the number of older patients undergoing bariatric surgery. Nevertheless, there is still conflicting data regarding surgical safety in this population.
OBJECTIVES


The aim of this study was to compare the surgical morbidity of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) for older patients.
SETTING


University hospital, São Paulo, Brazil.
METHODS


We performed a prospective randomized clinical trial from September 2017 to May 2019. Obese patients aged ≥65 years were randomized to LSG or LRYGB. Data collection included demographic information, body mass index (BMI), and co-morbidities. We assessed readmission, postoperative complications, and mortality. Complications were scored according to Clavien-Dindo classification.
RESULTS


A total of 36 patients, with a BMI between 35.5 and 52.8 kg/m 2  were randomized to either LSG (18 patients) or LRYGB (18 patients). The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13). Severe complication was more prevalent in LRYGB patients but had no statistically significant difference (0 versus 3, P = .07). Each group had 1 readmission and there was no mortality in 90-day follow-up.
CONCLUSIONS


Morbidity and mortality rates of bariatric surgery are low in elderly obese patients. Despite not statistically significant, LSG had a lower rate of severe complications compared with LRYGB in this population setting.",2020,"The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13).","['September 2017 to May 2019', 'older patients', 'elderly obese patients', 'Bariatric surgery in the elderly', '36 patients, with a BMI between 35.5 and 52.8 kg/m 2', 'older patients undergoing bariatric surgery', 'University hospital, São Paulo, Brazil', 'Obese patients aged ≥65 years']","['LSG or LRYGB', 'laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB', 'sleeve gastrectomy and Roux-en-Y gastric bypass', 'bariatric surgery', 'LSG']","['surgical morbidity', 'readmission, postoperative complications, and mortality', 'demographic information, body mass index (BMI), and co-morbidities', 'overall complication rate', 'Morbidity and mortality rates', 'severe complications', 'Severe complication']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",36.0,0.116361,"The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13).","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pajecki', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Batista', 'Initials': 'ACB', 'LastName': 'Dantas', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil. Electronic address: carolbatista.med@gmail.com.'}, {'ForeName': 'Ana Lumi', 'Initials': 'AL', 'LastName': 'Kanaji', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Daniel Riccioppo Cerqueira Ferreira', 'Initials': 'DRCF', 'LastName': 'de Oliveira', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.05.030']
2396,32747361,"Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid.","Afabicin (formerly Debio 1450, AFN-1720) is a prodrug of afabicin desphosphono, an enoyl-acyl carrier protein reductase (FabI) inhibitor, and is a first-in-class antibiotic with a novel mode of action to specifically target fatty acid synthesis in  Staphylococcus  spp. The efficacy, safety, and tolerability of afabicin were compared with those of vancomycin/linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to staphylococci in this multicenter, parallel-group, double-blind, and double-dummy phase 2 study. Randomized patients (1:1:1) received either low-dose (LD) afabicin (intravenous [i.v.] 80 mg, followed by oral 120 mg, twice a day [BID]), high-dose (HD) afabicin (i.v. 160 mg, followed by oral 240 mg, BID), or vancomycin/linezolid (i.v. vancomycin 1 g or 15 mg/kg, followed by oral linezolid 600 mg, BID). The most frequent baseline pathogen was  Staphylococcus aureus  (97.5% of microbiological intent-to-treat [mITT] population), and 50.4% of patients had methicillin-resistant  S. aureus  Clinical response rates at 48 to 72 h postrandomization in the mITT population were comparable among treatment groups (94.6%, 90.1%, and 91.1%, respectively). Both LD and HD afabicin were noninferior to vancomycin/linezolid (differences, -3.5% [95% confidence interval {CI}, -10.8%, 3.9%] and 1.0% [95% CI, -7.3%, 9.2%], respectively). Most common treatment-emergent adverse events were mild and were headache (9.1% and 16.8%) and nausea (6.4% and 8.4%) with LD and HD afabicin, respectively. Afabicin was efficacious and well tolerated in the treatment of ABSSSI due to staphylococci, and these data support further development of afabicin for the treatment of ABSSSI and potentially other types of staphylococcal infections. (This study has been registered at ClinicalTrials.gov under identifier NCT02426918.).",2020,"Both LD and HD afabicin were non-inferior to vancomycin/linezolid (differences: -3.5%, 95% CI [-10.8%, 3.9%] and 1.0%, 95% CI [",[],"[' low dose (LD) afabicin ', 'Afabicin (formerly Debio 1450, AFN-1720', 'vancomycin/linezolid', 'vancomycin/linezolid (IV vancomycin', 'linezolid']","['headache', 'efficacy, safety and tolerability', 'nausea', 'methicillin-resistant  S. aureus  Clinical response rates']",[],"[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517603', 'cui_str': '1720'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0523739,"Both LD and HD afabicin were non-inferior to vancomycin/linezolid (differences: -3.5%, 95% CI [-10.8%, 3.9%] and 1.0%, 95% CI [","[{'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Wittke', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Vincent', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Southbay Pharma Research, Buena Park, California, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, California, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Kabler', 'Affiliation': 'Sunrise Hospital and Medical Center, Las Vegas, Nevada, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite, San Diego, California, USA.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Leylavergne', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'Guennaëlle', 'Initials': 'G', 'LastName': 'Dieppois', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland guennaelle.dieppois@debiopharm.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00250-20']
2397,32756078,The effect of Sancai powder on glycemic variability of type 2 diabetes in the elderly: A randomized controlled trial.,"BACKGROUND


Type 2 diabetes is a kind of metabolic disease. Its clinical characteristic is hyperglycemia. Recently, more and more elderly people suffer from type 2 diabetes, and the glycemic variability of the elderly is greater. In addition, blood sugar variation is more likely to cause diabetes complications than simple hyperglycemia. Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience. It has the effect of lowering blood sugar and alleviating clinical symptoms of diabetes. But the existing evidence of its efficacy on glycemic variability is insufficient. So, in our study, the randomized controlled trials will be used as a research method to explore the effects of SC on glycemic variability of type 2 diabetes.
METHOD


We will use randomized controlled experiments based on the recommended diagnostic criteria, inclusion and exclusion criteria. A total of 60 elderly patients with type 2 diabetes will be randomly divided into treatment group and control group, 30 cases in each group. The control group will receive conventional western medicine and the intervention group will receive SC combined with western medicine. The standard deviation and coefficient of variation of blood glucose level will be used as evaluation indexes.
DISCUSSION


This study can provide evidence for the clinical efficacy and safety of SC in elderly patients with type 2 diabetes mellitus.
TRIAL REGISTRATION


This study is registered on the Chinese Clinical Trial Registry: ChiCTR2000032611.",2020,Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience.,"['type 2 diabetes in the elderly', 'elderly patients with type 2 diabetes mellitus', '60 elderly patients with type 2 diabetes']","['Sancai podwer (SC', 'Sancai powder', 'conventional western medicine and the intervention group will receive SC combined with western medicine', 'SC']","['standard deviation and coefficient of variation of blood glucose level', 'glycemic variability']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",60.0,0.0609136,Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience.,"[{'ForeName': 'Dongqi', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xuke', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020750']
2398,32761191,"Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet Among Children With Drug-Resistant Epilepsy: A Randomized Clinical Trial.","Importance


The ketogenic diet (KD) has been used successfully to treat children with drug-resistant epilepsy. Data assessing the efficacy of the modified Atkins diet (MAD) and low glycemic index therapy (LGIT) diet compared with the KD are scarce.
Objective


To determine whether the MAD and LGIT diet are noninferior to the KD among children with drug-resistant epilepsy.
Design, Setting, and Participants


One hundred seventy children aged between 1 and 15 years who had 4 or more seizures per month, had not responded to 2 or more antiseizure drugs, and had not been treated previously with the KD, MAD, or LGIT diet were enrolled between April 1, 2016, and August 20, 2017, at a tertiary care referral center in India.
Exposures


Children were randomly assigned to receive the KD, MAD, or LGIT diet as additions to ongoing therapy with antiseizure drugs.
Main Outcomes and Measures


Primary outcome was percentage change in seizure frequency after 24 weeks of dietary therapy in the MAD cohort compared with the KD cohort and in the LGIT diet cohort compared with the KD cohort. The trial was powered to assess noninferiority of the MAD and LGIT diet compared with the KD with a predefined, noninferiority margin of -15 percentage points. Intention-to-treat analysis was used.
Results


One hundred fifty-eight children completed the trial: KD (n = 52), MAD (n = 52), and LGIT diet (n = 54). Intention-to-treat analysis showed that, after 24 weeks of intervention, the median (interquartile range [IQR]) change in seizure frequency (KD: -66%; IQR, -85% to -38%; MAD: -45%; IQR, -91% to -7%; and LGIT diet: -54%; IQR, -92% to -19%) was similar among the 3 arms (P = .39). The median difference, per intention-to-treat analysis, in seizure reduction between the KD and MAD arms was -21 percentage points (95% CI, -29 to -3 percentage points) and between the KD and LGIT arms was -12 percentage points (95% CI, -21 to 7 percentage points), with both breaching the noninferiority margin of -15 percentage points. Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms but were significantly less in the LGIT diet arm (19 of 57 [33.3%]).
Conclusions and Relevance


Neither the MAD nor the LGIT diet met the noninferiority criteria. However, the results of this study for the LGIT diet showed a balance between seizure reduction and relatively fewer adverse events compared with the KD and MAD. These potential benefits suggest that the risk-benefit decision with regard to the 3 diet interventions needs to be individualized.
Trial Registration


ClinicalTrials.gov Identifier: NCT02708030.",2020,Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms,"['children with drug-resistant epilepsy', 'Participants\n\n\nOne hundred seventy children aged between 1 and 15 years who had 4 or more seizures per month, had not responded to 2 or more antiseizure drugs, and had not been treated previously with the KD, MAD, or LGIT diet were enrolled between April 1, 2016, and August 20, 2017, at a tertiary care referral center in India', 'One hundred fifty-eight children completed the trial: KD (n\u2009=\u200952), MAD (n\u2009=\u200952), and', 'Exposures\n\n\nChildren', 'Children With Drug-Resistant Epilepsy']","['LGIT diet', 'Ketogenic Diet, Modified Atkins Diet, and Low Glycemic Index Therapy Diet', 'MAD and LGIT diet', 'modified Atkins diet (MAD) and low glycemic index therapy (LGIT) diet', 'ketogenic diet (KD', 'KD, MAD, or LGIT diet as additions to ongoing therapy with antiseizure drugs']","['seizure frequency', 'adverse events', 'MAD', 'median difference, per intention-to-treat analysis, in seizure reduction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",170.0,0.11082,Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms,"[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Sondhi', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarwala', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Biswaroop', 'Initials': 'B', 'LastName': 'Chakrabarty', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Jauhari', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gurudyal S', 'Initials': 'GS', 'LastName': 'Toteja', 'Affiliation': 'Scientist H & Head (Nutrition), Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kossoff', 'Affiliation': 'Department of Neurology, Johns Hopkins Hospital, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sheffali', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Center of Excellence & Advanced Research on Childhood Neurodevelopmental Disorders, Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2282']
2399,32759193,Prevention of benign paroxysmal positional vertigo with vitamin D supplementation: A randomized trial.,"OBJECTIVE


To assess the effect of vitamin D and calcium supplementation in preventing recurrences of benign paroxysmal positional vertigo (BPPV).
METHODS


We performed an investigator-initiated, blinded-outcome assessor, parallel, multicenter, randomized controlled trial in 8 hospitals between December 2013 and May 2017. Patients with confirmed BPPV were randomly assigned to the intervention (n = 518) or the observation (n = 532) group after successful treatment with canalith repositioning maneuvers. The primary outcome was the annual recurrence rate (ARR). Patients in the intervention group had taken vitamin D 400 IU and 500 mg of calcium carbonate twice a day for 1 year when serum vitamin D level was lower than 20 ng/mL. Patients in the observation group were assigned to follow-ups without further vitamin D evaluation or supplementation.
RESULTS


The intervention group showed a reduction in the ARR (0.83 [95% confidence interval (CI), 0.74-0.92] vs 1.10 [95% CI, 1.00-1.19] recurrences per 1 person-year) with an incidence rate ratio of 0.76 (95% CI, 0.66-0.87,  p  < 0.001) and an absolute rate ratio of -0.27 (-0.40 to -0.14) from intention-to-treat analysis. The number needed to treat was 3.70 (95% CI, 2.50-7.14). The proportion of patients with recurrence was also lower in the intervention than in the observation group (37.8 vs 46.7%,  p  = 0.005).
CONCLUSIONS


Supplementation of vitamin D and calcium may be considered in patients with frequent attacks of BPPV, especially when serum vitamin D is subnormal.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with BPPV, vitamin D and calcium supplementation reduces recurrences of BPPV.",2020,The intervention group showed a reduction in the ARR [0.83,"['8 hospitals between December 2013 and May 2017', 'patients with frequent attacks of BPPV', 'Patients with confirmed BPPV', 'patients with BPPV']","['vitamin D 400 IU and 500 mg of calcium carbonate', 'Vit D Supplementation', 'vitamin D evaluation or supplementation', 'canalith repositioning maneuvers', 'vitamin D and calcium', 'vitamin D and calcium supplementation']","['proportion of patients with recurrence', 'absolute rate ratio', 'serum vitamin D level', 'annual recurrence rate (ARR', 'recurrences of benign paroxysmal positional vertigo (BPPV']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}]",8.0,0.503458,The intervention group showed a reduction in the ARR [0.83,"[{'ForeName': 'Seong-Hae', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ji-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}, {'ForeName': 'Hyo-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}, {'ForeName': 'Jeong-Yoon', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ja-Won', 'Initials': 'JW', 'LastName': 'Koo', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Kwang-Dong', 'Initials': 'KD', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Seung-Han', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Seo-Young', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Jae Han', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Ileok', 'Initials': 'I', 'LastName': 'Jung', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital.'}, {'ForeName': 'Sooyeon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (S.-H.J.), Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon; Departments of Neurology (J.-S.K.) and Otolaryngology (J.-W.K.), Seoul National University College of Medicine; Dizziness Center (J.-S.K., J.-Y.C., J.-W.K.), Research Administration Team (H.-J.K.), and Medical Research Collaborating Center (S.A., S.K.), Seoul National University Bundang Hospital, Seongnam; Department of Neurology (K.-D.C., S.-Y.C.), Pusan National University Hospital, Pusan National University School of Medicine; Department of Neurology (J.-Y.P.), Ulsan University College of Medicine, Ulsan University Hospital; Department of Neurology (S.-H.L.), Chonnam National University Medical School, Gwangju; Department of Neurology (S.-Y.O., T.-H.Y.), Chonbuk National University School of Medicine, Jeonju; Department of Neurology (J.H.P.), School of Medicine, Catholic University of Daegu, Korea; and Department of Neurology (I.J.), Korea University Ansan Hospital. jisookim@snu.ac.kr.'}]",Neurology,['10.1212/WNL.0000000000010343']
2400,32762148,Effects of a Lifestyle Intervention Based on Type D Personality in Overweight and Obese Middle-Aged Women: A Feasibility Study.,"BACKGROUND


Obesity is an important public health problem, particularly among middle-aged women. Type D personality, characterized by negative affectivity and social inhibition, is prevalent among obese and overweight middle-aged women and has been linked to maladaptive health-related behaviors and unhealthy lifestyle. Lifestyle interventions based on type D personality could be a first step in combatting obesity in middle-aged women.
AIM


To identify the effects of a lifestyle intervention based on type D personality on health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition in overweight and obese middle-aged women.
METHODS


A total of 36 overweight and obese middle-aged women participated in a quasi-experimental design using a non-equivalent control group pretest-posttest. The experimental group received a total of eight sessions of a lifestyle intervention program based on type D personality over the course of four weeks. Outcomes were measured health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition (body weight, body mass index, body fat, and abdominal fat).
RESULTS


Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality. Body weight and body mass index decreased significantly in the experimental group compared to the control group.
LINKING EVIDENCE TO ACTION


Further research on various intervention programs for overweight and obese middle-aged women is warranted, including lifestyle interventions based on type D personality.",2020,"Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality.","['overweight and obese middle-aged women', 'Type D Personality in Overweight and Obese Middle-Aged Women', 'middle-aged women', 'obese and overweight middle-aged women', '36 overweight and obese middle-aged women participated in a']","['lifestyle intervention', 'Lifestyle Intervention', 'Lifestyle interventions', 'quasi-experimental design using a non-equivalent control group pretest-posttest', 'lifestyle intervention program']","['health-promoting lifestyle behaviors', 'psychological distress and type D personality', 'health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition (body weight, body mass index, body fat, and abdominal fat', 'Body weight and body mass index', 'health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658239', 'cui_str': 'Personality Type D'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3658239', 'cui_str': 'Personality Type D'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}]",36.0,0.0166452,"Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality.","[{'ForeName': 'Sung Reul', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Korea University, Seoul, South Korea.'}, {'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Nho', 'Affiliation': 'College of Nursing, Jeonbuk Research Institute of Nursing Science, Jeonbuk National University, Jeonju, South Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Jeonbuk Research Institute of Nursing Science, Jeonbuk National University, Jeonju, South Korea.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Hur', 'Affiliation': 'Department of Internal Medicine, Jiangun Medical Center, Jinangun, South Korea.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12457']
2401,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
2402,32762637,Colorectal Cancer Screening Patient Navigation for Patients with Mental Illness and/or Substance Use Disorder: Pilot Randomized Control Trial.,"OBJECTIVE


Colorectal cancer (CRC) is the second leading cause of cancer death in the US. Screening has decreased CRC mortality. However, disadvantaged patients, particularly those with mental illness or substance use disorder (SUD), are less likely to be screened. The aim of this trial was to evaluate the impact of a patient navigation program on CRC screening in patients with mental illness and/or SUD.
METHODS


A pilot randomized nonblinded controlled trial was conducted from January to June 2017 in an urban community health center serving a low-income population. We randomized 251 patients aged 50-74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention ( n  = 126) or usual care ( n  = 125) stratified by mental illness, SUD, or dual diagnosis. Intervention group patients received a letter followed by a phone call from patient navigators. Navigators helped patients overcome their individual barriers to CRC screening including: education, scheduling, explanation of bowel preparation, lack of transportation or accompaniment to appointments. If patient refused colonoscopy, navigators offered fecal occult blood testing. The main measure was proportion of patients completing CRC screening in intervention and usual care groups.
RESULTS


Navigators contacted 85 patients (67%) in the intervention group and 26 declined to participate. In intention-to treat analysis, more patients in the intervention group received CRC screening than in the usual care group, 19% versus 10.4% ( p  = .04). Among 56 intervention patients who received navigation, 19 completed screening (33.9% versus 10.4% in the control group,  p  = .001). In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
CONCLUSIONS


A patient navigation program improved CRC screening rates in patients with mental illness and/or SUD. Larger studies in diverse care settings are needed to demonstrate generalizability and explore which modality of CRC screening is most acceptable and which navigator activities are most effective for this vulnerable population.
TRIALS REGISTRATION NUMBER


2016P001322.",2020,"In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
","['Colorectal cancer (CRC', 'patients with mental illness and/or SUD', '251 patients aged 50-74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention ( n \u2009=\u2009126) or usual care ( n \u2009=\u2009125) stratified by mental illness, SUD, or dual diagnosis', 'January to June 2017 in an urban community health center serving a low-income population', 'disadvantaged patients, particularly those with mental illness or substance use disorder (SUD', 'Patients with Mental Illness and/or Substance Use Disorder']","['patient navigation program', 'letter followed by a phone call from patient navigators', 'Colorectal Cancer Screening Patient Navigation']","['CRC mortality', 'CRC screening', 'CRC screening rates']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",251.0,0.119177,"In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Abuelo', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Knudsen', 'Affiliation': 'Massachusetts General Hospital Institute for Technology Assessment, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morrill', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Corona', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Derri', 'Initials': 'D', 'LastName': 'Shtasel', 'Affiliation': 'Massachusetts General Hospital, Division of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Percac-Lima', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2020.1802542']
2403,32767414,Effect of Feru-guard 100M on amyloid-beta deposition in individuals with mild cognitive impairment.,"AIM


Many researchers argue that Alzheimer's disease is at least partly caused by deposition of amyloid beta (Aβ) in the brain. Ferulic acid (FA) and Angelica archangelica (AA) are candidate agents for reducing Aβ and improving cognitive function. Feru-guard 100M is a supplement containing FA and AA extract. Using this supplement, we planned to assess the effect of FA and AA on Aβ deposition in the human brain.
METHODS


This was an open-label, interventional multi-institutional joint study of Kobe University and the Institute of Biomedical Research and Innovation (Kobe, Japan). Seventeen subjects diagnosed with mild cognitive impairment were divided into two groups: the intervention group (n = 10) and the control group (n = 7). The subjects in the intervention group used Feru-guard 100M every day for 48 weeks, whereas the subjects in the control group did not use the supplement. We assessed the differences between the two groups by examining Aβ deposition and brain atrophy at 48 weeks and cognitive function every 24 weeks. We used carbon-11-labelled Pittsburgh compound B (PiB) positron emission tomography to evaluate Aβ deposition.
RESULTS


There were no significant differences in Aβ deposition, brain atrophy, and cognitive function between the two groups. Specifically, differences in Aβ deposition change in seven regions of interest examined with PiB positron emission tomography, brain atrophy change in four indicators of voxel-based morphometry, and cognitive impairment measured by five psychological tests were not significantly between the two groups.
CONCLUSION


Treatment with Feru-guard 100M, a supplement containing FA and AA extract, for 48 weeks did not reduce cortical PiB retention, which reflects Aβ deposition. It also did not suppress the aggravation of brain atrophy or decline in cognitive function.",2020,"There were no significant differences in Aβ deposition, brain atrophy, and cognitive function between the two groups.","['Seventeen subjects diagnosed with mild cognitive impairment', 'individuals with mild cognitive impairment']","['carbon-11-labelled Pittsburgh compound B (PiB) positron emission tomography', 'Ferulic acid (FA) and Angelica archangelica (AA', 'Feru-guard 100M']","['amyloid-beta deposition', 'cortical PiB retention', 'Aβ deposition, brain atrophy, and cognitive function']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0302944', 'cui_str': 'Carbon-11'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}, {'cui': 'C0877891', 'cui_str': 'Angelica archangelica'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",17.0,0.0268915,"There were no significant differences in Aβ deposition, brain atrophy, and cognitive function between the two groups.","[{'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Psychiatry, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yasuji', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Psychiatry, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sora', 'Affiliation': 'Department of Psychiatry, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12581']
2404,32763106,Comment on: Bariatric surgery in the elderly: a randomized prospective study comparing safety of sleeve gastrectomy and Roux-en-Y gastric bypass (BASE Trial).,,2020,,['elderly'],"['sleeve gastrectomy and Roux-en-Y gastric bypass', 'Bariatric surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]",[],,0.0107772,,"[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Lo Menzo', 'Affiliation': 'The Bariatric And Metabolic Institute, Cleveland Clinic Florida, Weston, Florida.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.048']
2405,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
2406,32768597,Reply to letter to the editor: 'effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands - a randomized controlled trial'.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.0830795,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pelle', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: T.Pelle@maartenskliniek.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bevers', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Research Methodology, Measurement, and Data-Analysis, Behavioural, Management and Social Sciences, University of Twente, Enschede, the Netherlands; Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'F H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.07.007']
2407,32768599,Commentary on: effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.10498,,"[{'ForeName': 'S F J', 'Initials': 'SFJ', 'LastName': 'Chudy', 'Affiliation': 'Erasmus MC, Netherlands. Electronic address: stanchudy@gmail.com.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Volwater', 'Affiliation': 'Leiden University, Netherlands. Electronic address: mike_volwater@hotmail.com.'}, {'ForeName': 'Ö F', 'Initials': 'ÖF', 'LastName': 'Ozbulut', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: o.ozbulut@erasmusmc.nl.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: b.koes@erasmusmc.nl.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.06.011']
2408,32766779,Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial.,"OBJECTIVE


No study to our knowledge has investigated the effects longer than 1 year of manual therapy in carpal tunnel syndrome (CTS). The purpose of this study was to investigate the effects of manual therapy versus surgery at 4-year follow-up and to compare the post-study surgery rate in CTS.
METHODS


This randomized controlled trial was conducted in a tertiary public hospital and included 120 women with CTS who were randomly allocated to manual therapy or surgery. The participants received 3 sessions of physical therapy, including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home. Primary outcome was pain intensity (mean and the worst pain). Secondary outcomes included functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale. Outcomes for this analysis were assessed at baseline, 1 year, and 4 years. The rate of surgical intervention received by each group was assessed throughout the study.
RESULTS


At 4 years, 97 (81%) women completed the study. Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1) and 4 years (mean pain: MD = 0.1, 95% CI = -0.2 to 0.4; worst pain: MD = 0.2, 95% CI = -0.8 to 1.2; function: MD = 0.1, 95% CI = -0.1 to 0.3; symptom severity: MD = 0.2, 95% CI = -0.2 to 0.6). Self-perceived improvement was also similar in both groups. No between-group differences (15% physical therapy vs 13% surgery) in surgery rate were observed during the 4 years.
CONCLUSIONS


In the long term, manual therapy, including desensitization maneuvers of the central nervous system, resulted in similar outcomes and similar surgery rates compared with surgery in women with CTS. Both interventions were combined with a tendon/nerve gliding exercise program at home.
IMPACT


This is the first study to our knowledge to report clinical outcomes and surgical rates during a 4-year follow-up and will inform decisions regarding surgical versus conservative management of CTS.
LAY SUMMARY


Women with CTS may receive similar benefit from a more conservative treatment-manual therapy-as they would from surgery.",2020,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","['carpal tunnel syndrome CTS', 'carpal tunnel syndrome (CTS', 'At 4\xa0years, 97 (81%) women completed the study', 'Carpal Tunnel Syndrome', 'tertiary public hospital and included 120 women with CTS']","['tendon/nerve gliding exercise program at home', 'manual therapy', 'physical therapy including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home', 'manual therapy or surgery', 'Manual Therapy Versus Surgery']","['surgery rate', 'pain intensity (mean and the worst pain', 'rate of surgical intervention', 'functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale', 'surgery rates']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",120.0,0.131334,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Avenida de Atenas s/n, Alcorcón, Madrid, Spain 28922, and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pareja', 'Affiliation': 'Department of Neurology and Neurophysiology, Hospital Universitario Fundación, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain; and Instituto de Investigación Sanitaria del Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}]",Physical therapy,['10.1093/ptj/pzaa150']
2409,32769877,Protective effect of probiotics in patients with non-alcoholic fatty liver disease.,"To investigate the effects of probiotics on liver function, glucose and lipids metabolism, and hepatic fatty deposition in patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019 were randomly divided into the observation group and control group, 70 cases in each. The control group received the diet and exercise therapy, while the observation group received oral probiotics based on the control group, and the intervention in 2 groups lasted for 3 months. The indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora in 2 groups were compared before and after the treatment.Before the treatment, there were no significant differences on alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora in 2 groups (P > .05). After the treatment, ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora in the observation group were better than those in the control group, and the observation group was better after treatment than before. All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.",2020,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","['patients with NAFLD', 'patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019', 'patients with non-alcoholic fatty liver disease']","['diet and exercise therapy, while the observation group received oral probiotics', 'probiotics']","['ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora', 'liver functions, glucose and lipids metabolism, hepatic fatty deposition', 'liver function, glucose and lipids metabolism, and hepatic fatty deposition', 'indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0061485', 'cui_str': 'Glutamine phenylacetyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0164329,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","[{'ForeName': 'Gen-Shen', 'Initials': 'GS', 'LastName': 'Cai', 'Affiliation': 'Department of General Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine.'}]",Medicine,['10.1097/MD.0000000000021464']
2410,32769878,A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension.,"BACKGROUND


Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has a well-characterized efficacy and safety profile in patients with hypertension. AZL-M is approved for use in over 40 countries globally; however, it is not yet approved in China. Therefore, a phase 3 registration study to assess the efficacy (antihypertensive effect), safety, and tolerability of AZL-M compared with valsartan in Chinese patients with essential hypertension was undertaken.
METHODS


This multicenter, double-blind, randomized, 8-week phase 3 study compared AZL-M with valsartan in Chinese patients aged ≥18 years with essential hypertension. Endpoints included change from baseline to week 8 in trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters.
RESULTS


Overall, 612 patients (mean age, 57.1 years; 57.5% male) were randomized to AZL-M 80 mg (n = 209), AZL-M 40 mg (n = 199), or valsartan 160 mg (n = 204). Baseline mean scSBP was similar in all groups (157.9-158.5 mm Hg). The mean reduction in trough scSBP from baseline to week 8 was significantly greater with AZL-M 80 mg than with valsartan (-24.2 vs -20.6 mm Hg; P = .010), and noninferior with AZL-M 40 mg versus valsartan (-22.5 vs -20.6 mm Hg; P = .184). Mean reduction in 24-hour mean systolic blood pressure (n = 257) was significantly greater with both AZL-M 80 mg (-17.0 mm Hg; P < .001) and AZL-M 40 mg (-14.7 mm Hg; P = .014) than with valsartan (-9.4 mm Hg). Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate. Dizziness was the most frequent treatment-related treatment-emergent adverse events (AZL-M 80 mg, 1.9%; AZL-M 40 mg, 1.5%; valsartan, 1.0%). The safety and tolerability of AZL-M were comparable with valsartan.
CONCLUSIONS


AZL-M was noninferior to valsartan at the 40-mg dose and superior to valsartan at the 80-mg dose in reducing trough scSBP, and showed acceptable safety-consistent with the AZL-M safety profile in other populations-in Chinese adults with hypertension.
TRIAL REGISTRATION NUMBER


NCT02480764.",2020,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"['612 patients (mean age, 57.1 years; 57.5% male', 'Chinese patients with essential hypertension was undertaken', 'Chinese patients with essential hypertension', 'patients with hypertension', 'Chinese patients aged ≥18 years with essential hypertension', 'Chinese adults with hypertension']","['AZL-M', 'valsartan', 'AZL-M with valsartan', 'AZL-M 40\u200amg (n\u200a=\u200a199), or valsartan', 'azilsartan medoxomil', 'Azilsartan medoxomil (AZL-M']","['Baseline mean scSBP', 'mean reduction in trough scSBP', 'efficacy (antihypertensive effect), safety, and tolerability', 'safety and tolerability of AZL-M', 'Mean reduction in 24-hour mean systolic blood pressure', 'Dizziness', 'trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters']","[{'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C2979834', 'cui_str': 'azilsartan medoxomil 40 MG'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",612.0,0.157334,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Hospital of Liaoning Province, Liaoning.""}, {'ForeName': 'Zeqi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of NanChang University, Jiangxi.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, the Affiliated Hospital of Xuzhou Medical College.'}, {'ForeName': 'Chengchun', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Southeast University, Zhongda Hospital, Jiangsu.'}, {'ForeName': 'Zhuhua', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Tianjin People's Hospital, Tianjin.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Hebei Cangzhou Central Hospital, Hebei.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Department of Cardiology, Nanjing Medical University Affiliated 2nd Hospital, Jiangsu, China.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Hisada', 'Affiliation': 'Global Patient Safety Evaluation, Takeda Development Center Americas, Inc., Deerfield, IL.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Statistics and Quantitative Sciences, Takeda Development Center Americas, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Science, Takeda Development Center Asia, Pte. Ltd., Shanghai, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021465']
2411,32769524,Clinical Efficacy of Topical Tranexamic Acid With Microneedling in Melasma.,"BACKGROUND


Melasma is a common, recurrent, and refractory cause of facial pigmentation resulting in cosmetic disfigurement. Tranexamic acid (TA) has been used systemically and locally for clearance of pigmentation.
OBJECTIVE


To assess the clinical efficacy of topical TA (10%) with microneedling in melasma.
METHODS


A split face, prospective, randomized, open-label study with a sample size of 40. Left or right side of the face was chosen randomly and microneedling was done on both the sides, followed by 10% TA solution application on one side of the face (test side) and distilled water on the other side of face (control). The procedure was done at 2 weekly intervals (0, 2, 4, and 6 weeks). Clinical images were taken at each visit including modified Melasma Area and Severity Index (mMASI) scoring of each half of the face to assess the clinical response along with patient satisfaction scores and side effects.
RESULTS


On the test side, there was 65.92% improvement in the mean mMASI score compared with 20.75% on the control side of the face at the end of 8 weeks.
CONCLUSION


Tranexamic acid may be a promising therapeutic agent in melasma and the topical solution along with microneedling seems to be efficacious.",2020,"On the test side, there was 65.92% improvement in the mean mMASI score compared with 20.75% on the control side of the face at the end of 8 weeks.
",['Melasma'],"['Tranexamic acid (TA', 'topical TA', 'Tranexamic acid', 'Topical Tranexamic Acid']",['mean mMASI score'],"[{'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0485299,"On the test side, there was 65.92% improvement in the mean mMASI score compared with 20.75% on the control side of the face at the end of 8 weeks.
","[{'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Bhalla', 'Affiliation': ''}, {'ForeName': 'Gurvinder', 'Initials': 'G', 'LastName': 'Pal Thami', 'Affiliation': ''}, {'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Sandhu', 'Affiliation': 'Dermatology and Venereology, Government Medical College and Hospital, Chandigarh, India.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002520']
2412,32769914,Effect of butylphthalide on new cerebral microbleeds in patients with acute ischemic stroke.,"BACKGROUND


To evaluate the effect of dl-3-N-butylphthalide (NBP) on new cerebral microbleeds (CMBs) in patients with acute ischemic stroke (AIS).
METHODS


We will prospectively enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital. Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1. Patients will complete the brain magnetic resonance imaging within 48 hours and 14 days after stroke onset to observe the CMBs through susceptibility weighted imaging, and evaluate whether the use of NBP will affect the new CMBs in AIS patients. SPSS 20.0 will be used for statistical analyses.
RESULT


We will provide practical and targeted results assessing the safety of NBP for AIS patients, to provide reference for clinical use of NBP.
CONCLUSION


The stronger evidence about the effect of NBP on new CMBs in AIS patients will be provided for clinicians.",2020,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[""enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital"", 'patients with acute ischemic stroke (AIS', 'patients with acute ischemic stroke']","['butylphthalide', 'dl-3-N-butylphthalide (NBP', 'NBP group (NBP injection) or the control group (NBP injection placebo', 'NBP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.122005,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[{'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Zhiqun', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhai', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yanrong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Clinical Pharmacy, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}]",Medicine,['10.1097/MD.0000000000021594']
2413,32769919,"Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial.","BACKGROUND


Low back pain (LBP) affects approximately 51% to 57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.
METHODS AND ANALYSIS


We conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to 2 groups: intervention group, where patients received LED photobiomodulation therapy 3 times a week for 2 weeks, and the sham group, where patients had sham therapy 3 times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index. The outcome measures were assessed before therapy and 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.
DISCUSSION


This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. Our results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain.
TRIAL REGISTRATION NUMBER


NCT04424823.",2020,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","['non-specific low back pain in working nurses', ""hospital nurses and nurses' aides in Europe"", ""patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain"", '148 patients with NSCLBP']","['Light-emitting diode photobiomodulation therapy', 'LED therapy', 'light-emitting diode (LED) therapy', 'low-level laser therapy', 'LED photobiomodulation therapy', 'Light therapy', 'placebo']","['visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times', 'multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444228', 'cui_str': 'Range of motion assessment'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",148.0,0.57227,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","[{'ForeName': 'Yen-Po', 'Initials': 'YP', 'LastName': 'Lin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Ying-Hao', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Shih-Fang', 'Initials': 'SF', 'LastName': 'Chin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan (R.O.C.).'}, {'ForeName': 'Wei-Tso', 'Initials': 'WT', 'LastName': 'Chia', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}]",Medicine,['10.1097/MD.0000000000021611']
2414,32770131,"A randomized, double-blind water taste test to evaluate the equivalence of taste between tap water and filtered water in the Taipei metropolis.","High water quality and sufficient water availability are the main concerns of water users. Promoting the efficient use of tap water can contribute to sustainable drinking water management and progress towards Sustainable Development Goals. In many metropolises, water suppliers treat municipal water with appropriate treatment processes and well-maintained distribution infrastructure. Under this circumstance, it is acceptable that municipal water can be a source of drinking water. The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination. However, adding chlorine to tap water may affect the organoleptic properties of drinking water. On the other hand, the use of point-of-use (POU) water dispensers, which provides an additional treatment step on tap water, is not energy-efficient. A randomized, double-blind water taste test was conducted in the Taipei metropolis to assess whether tap water from public drinking fountains and filtered water from POU water dispensers have similar organoleptic properties. An odds ratio (OR) and the area under the receiver operating characteristic curve (AUC) were used to measure the participants' ability to distinguish between the two water varieties. A five-region hypothesis test was conducted to test the OR, and a 95% bootstrap confidence interval of the AUC was calculated. The results of the study showed that the 95% five-region confidence interval of OR equal to (0.5, 1.49), and the 95% bootstrap confidence interval of AUC equal to (0.42, 0.56). These results implied that people in the Taipei metropolis could not distinguish between tap water and filtered water. It is recommended that more drinking fountains be installed and maintained fully functional and clean to achieve excellence in tap water access.",2020,"The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination.",[],[],"['odds ratio (OR) and the area under the receiver operating characteristic curve (AUC', 'organoleptic properties of drinking water']",[],[],"[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}]",,0.0565847,"The presence of residual chlorine in tap water, connected to municipal water supply, inactivates pathogenic microorganisms and prevents recontamination.","[{'ForeName': 'Jing-Rong', 'Initials': 'JR', 'LastName': 'Jhuang', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Rm. 536, No. 17, Xuzhou Rd., Taipei, 100, Taiwan.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Rm. 536, No. 17, Xuzhou Rd., Taipei, 100, Taiwan. wenchung@ntu.edu.tw.'}, {'ForeName': 'Chang-Chuan', 'Initials': 'CC', 'LastName': 'Chan', 'Affiliation': 'Innovation and Policy Center for Population Health and Sustainable Environment, College of Public Health, National Taiwan University, Taipei, Taiwan. ccchan@ntu.edu.tw.'}]",Scientific reports,['10.1038/s41598-020-70272-y']
2415,32770186,"How to Teach Medical Students About Pain and Dementia: E-Learning, Experiential Learning, or Both?","OBJECTIVE


Pain management in persons with mild to moderate dementia poses unique challenges because of altered pain modulation and the tendency of some individuals to perseverate. We aimed to test the impact of an e-learning module about pain in communicative people with dementia on third-year medical students who had or had not completed an experiential geriatrics course.
DESIGN


Analysis of pre- to postlearning changes and comparison of the same across the student group.
SETTING


University of Pittsburgh School of Medicine and Saint Louis University School of Medicine.
SUBJECTS


One hundred four University of Pittsburgh and 57 Saint Louis University medical students.
METHODS


University of Pittsburgh students were randomized to view either the pain and dementia module or a control module on pain during a five-day geriatrics course. Saint Louis University students were asked to complete either of the two modules without the context of a geriatrics course. A 10-item multiple choice knowledge test and three-item attitudes and confidence questionnaires were administered before viewing the module and up to seven days later.
RESULTS


Knowledge increase was significantly greater among students who viewed the dementia module while participating in the geriatrics course than among students who viewed the module without engaging in the course (P < 0.001). The modules did not improve attitudes in any group, while student confidence improved in all groups.
CONCLUSIONS


Medical students exposed to e-learning or experiential learning demonstrated improved confidence in evaluating and managing pain in patients with dementia. Those exposed to both educational methods also significantly improved their knowledge.",2020,"The modules did not improve attitudes in any group, while student confidence improved in all groups.
","['University of Pittsburgh students', 'Saint Louis University students', 'patients with dementia', 'communicative people with dementia on third-year medical students who had or had not completed an experiential geriatrics course', 'One hundred four University of Pittsburgh and 57 Saint Louis University medical students', 'Teach Medical Students About Pain and Dementia', 'University of Pittsburgh School of Medicine and Saint Louis University School of Medicine', 'persons with mild to moderate dementia']","['e-learning module about pain', 'pain and dementia module or a control module']","['student confidence', 'confidence in evaluating and managing pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0014048', 'cui_str': 'St. Louis encephalitis virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0317668,"The modules did not improve attitudes in any group, while student confidence improved in all groups.
","[{'ForeName': 'Keelin', 'Initials': 'K', 'LastName': 'Moehl', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rollin M', 'Initials': 'RM', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine (Geriatric Medicine), University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shega', 'Affiliation': 'VITAS Healthcare and University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Malec', 'Affiliation': 'Department of Medicine (Geriatric and Palliative Medicine), University of Chicago, Chicago, Illinois.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kelley Fitzgerald', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Robbins-Welty', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Zoberi', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tait', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'VITAS Healthcare and University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Deverts', 'Affiliation': 'Office of Research, University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Zsuzsa', 'Initials': 'Z', 'LastName': 'Horvath', 'Affiliation': 'Department of Dental Public Health, University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Department of Medicine (Geriatric Medicine), University of Pittsburgh, Pittsburgh, Pennsylvania.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa187']
2416,32772319,Does cognitive behavioral education reduce pain and improve joint function in patients after total knee arthroplasty? A randomized controlled trial.,"INTRODUCTION


Cognitive behavioral therapy (CBT) is an effective treatment for reducing the pain of knee osteoarthritis (OA) and improving joint function. However, there are few studies on the effect of CBT on the pain severity after total knee arthroplasty (TKA). This study investigates the effectiveness of a CBT program on pain, knee function, quality of life, and pain catastrophizing in patients after TKA.
METHODS


This was a randomized, parallel-group, controlled trial in which 100 patients with knee osteoarthritis (OA) prepared for TKA were randomly assigned to participate in CBT or usual care group. Evaluation outcomes include Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale before and after surgery.
RESULTS


We found that patients in the CBT group had a lower pain during activity from the fifth day (p = 0.003) to the third month (p = 0.019) after TKA. At the 12th month, the mean VAS score during activity in the CBT and usual care groups decreased from 4.5 to 0.8 and from 4.6 to 0.9, respectively, and there is no significant difference between the two groups. The PCS scores of patients in the CBT group were lower than those in the usual care group at 1st (p = 0.014) and 3rd months (p = 0.027) after surgery. No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
CONCLUSIONS


The CBT program was superior to usual care in reducing post-operative pain during activity from the fifth day to the third month and pain catastrophing in the first three months after TKA but has no statistically significantly differences in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
TRIAL REGISTRATION


Current Controlled Trials ChiCTR2000032857, date of registration: May, 14, 2020, retrospectively registered.",2020,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","['patients after TKA', '100 patients with knee osteoarthritis (OA) prepared for TKA', 'patients after total knee arthroplasty']","['CBT or usual care group', 'Cognitive behavioral therapy (CBT', 'CBT program', 'CBT']","['PCS scores', 'pain, knee function, quality of life, and pain catastrophizing', 'lower pain during activity', 'pain during rest, knee ROM, EQ-5D, OKS, and HSS', 'Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale', 'joint function', 'pain severity', 'mean VAS score during activity', 'pain of knee osteoarthritis (OA) and improving joint function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",100.0,0.0581903,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","[{'ForeName': 'Jian-Ning', 'Initials': 'JN', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. xzfs0561@163.com.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. 781733181@qq.com.""}]",International orthopaedics,['10.1007/s00264-020-04767-8']
2417,32768394,Impact of aerobic training with and without whole-body vibration training on metabolic features and quality of life in non-alcoholic fatty liver disease patients.,"The present study examined the effectiveness of adding exercises with whole-body vibration (WBV) to aerobic training in terms of metabolic features and quality of life. Patients with non-alcoholic fatty liver disease (NAFLD), confirmed on imaging, underwent an 8-week individualized exercise program randomized between aerobic training with and without WBV. Training was performed at 60-80% heart rate workload for 165 min/week. The WBV amplitude was 2-4mm and the training frequency was 30Hz, for 15min. Assessments were carried out on surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36). Insulin resistance was markedly reduced (-2.36; 95% CI: -4.96 to -0.24; P: 0.049) in aerobic training with WBV. The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95% CI: -23.36 to -6.25; P: 0.029). There were no significant differences between groups for the other metabolic features (P<0.05). All quality of life well-being domains improved in both groups (P<0.05). Given this reduction in insulin resistance, WBV can usefully be added to aerobic training. However, WBV did not provide further benefits in improving metabolic properties or quality of life.",2020,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"['non-alcoholic fatty liver disease patients', 'Patients with non-alcoholic fatty liver disease confirmed on imaging underwent an 8-week']","['exercises with whole-body vibration (WBV) to aerobic training', 'individualized exercise program randomized between aerobic training with and without WBV', 'aerobic training with and without whole-body vibration training']","['surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36', 'metabolic features and quality of life', 'serum aspartate transaminase', 'WBV amplitude', 'Insulin resistance', 'metabolic properties or quality of life']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0409261,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"[{'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Çevik Saldiran', 'Affiliation': 'Department of physiotherapy and rehabilitation, faculty of health science, Bitlis Eren University, Ahmet-Eren boulevard, Rahva street, 13000 Bitlis, Turkey. Electronic address: tlyfztcvk@gmail.com.'}, {'ForeName': 'Fatma Karantay', 'Initials': 'FK', 'LastName': 'Mutluay', 'Affiliation': 'Department of physiotherapy and rehabilitation, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Yağci', 'Affiliation': 'Department of physical therapy and rehabilitation medicine, Marmara University, Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yilmaz', 'Affiliation': 'Department of gastroenterology medicine, Marmara University, Istanbul, Istanbul, Turkey.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.05.003']
2418,32769457,Expanding the Traditional History and Physical Examination to Address Chronic Diseases and Social Needs: A Multisite Randomized Control Trial of 4 Medical Schools.,"PURPOSE


This study gathers validity evidence of an expanded History and Physical examination (H&P 360) to address chronic diseases through incorporation of biopsychosocial elements that are lacking in traditional H&P assessments via a multisite randomized controlled trial among medical students.
METHOD


Third- and fourth-year medical students (n = 159) at 4 schools participated in an Objective Structured Clinical Examination designed with 2 cases for chronic disease. Students were randomized into the treatment group, which involved brief written instructions on how to use the H&P 360 followed by a standardized patient (SP) interaction, or the control group, which used the traditional H&P in an SP interaction without additional instructions. Validity evidence was gathered for content (alignment with an empirically derived expanded history list), response process (feedback from raters and learners on the process), internal structure (reliability and item-level psychometrics), relations to other variables (comparison between treatment and control groups), and consequences (survey results from learners on experience).
RESULTS


H&P 360 items were blueprinted by faculty experts. SP observation checklist grading was consistent, and postassessment debrief confirmed favorable educational experience among learners. The reliability of the H&P 360 was .76. Overall mean scores on the H&P 360 content (mean = 15.96, standard deviation [SD] = 3.66) were significantly higher compared with the traditional H&P (mean = 10.99, SD = 2.69, Cohen's d = 1.17, P < .001).
CONCLUSIONS


Medical students using the H&P 360 collected significantly more biopsychosocial information compared with students using the traditional H&P, providing empirical support for teaching and assessing biopsychosocial information. The assessment demonstrated strong validity evidence supporting the use of the H&P 360 assessment in medical schools.",2020,"CONCLUSIONS


Medical students using the H&P 360 collected significantly more biopsychosocial information compared to students using the traditional H&P, providing empirical support for teaching and assessing biopsychosocial information.","['medical students', 'Third- and fourth-year medical students (n = 159) at 4 schools participated in an Objective Structured Clinical Examination designed with two cases for chronic disease']","['expanded History and Physical (H&P 360) examination', 'H&P 360 followed by a standardized patient (SP) interaction, or the control group, which utilized the traditional H&P in an SP interaction without additional instructions']",['biopsychosocial information'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0150618', 'cui_str': 'History AND physical examination'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],360.0,0.0288305,"CONCLUSIONS


Medical students using the H&P 360 collected significantly more biopsychosocial information compared to students using the traditional H&P, providing empirical support for teaching and assessing biopsychosocial information.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kirley', 'Affiliation': 'K. Kirley is director of chronic disease prevention, Improving Health Outcomes, American Medical Association, Chicago, Illinois. R. Hayer is senior program manager, Improving Health Outcomes, American Medical Association, Chicago, Illinois. T. Khan is senior economist, Improving Health Outcomes, American Medical Association, Chicago, Illinois. E. Johnson is associate professor, Family & Community Medicine, and director, interprofessional education, Education Resources, University of North Dakota School of Medicine and Health Sciences, Grand Forks, North Dakota. E.S. Sanchez is associate program director, Internal Medicine Residency, and associate professor of internal medicine, University of California Davis, Sacramento, California. L. Kosowicz is associate professor and director, Clinical Skills Assessment Program, Department of Medicine, University of Connecticut School of Medicine, Farmington, Connecticut. V. Terry is clinical assistant professor, Department of Psychiatry, University of Texas Rio Grande Valley School of Medicine, Harlingen, Texas. D. Henderson is associate professor and chair, Department of Family Medicine, and associate dean for multicultural and community affairs, University of Connecticut School of Medicine, Farmington, Connecticut. C. Krebsbach is assistant director, standardized patient program, Department of Healthcare Simulation, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois. Y.S. Park is associate professor and associate head, Department of Medical Education, and director of research, educational affairs, University of Illinois College of Medicine at Chicago, Chicago, Illinois. M. Dekhtyar is research associate, Department of Medical Education, University of Illinois College of Medicine at Chicago, Chicago, Illinois. B.C. Williams is director, Global Health and Disparities Path of Excellence, and professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Hayer', 'Affiliation': ''}, {'ForeName': 'Tamkeen', 'Initials': 'T', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Erin Stephany', 'Initials': 'ES', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kosowicz', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Terry', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Krebsbach', 'Affiliation': ''}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dekhtyar', 'Affiliation': ''}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Williams', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003640']
2419,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
2420,32769863,Long-term beneficial effects of an online mind-body training program on stress and psychological outcomes in female healthcare providers: A non-randomized controlled study.,"Mind-body training (MBT) programs are effective interventions for relieving stress and improving psychological capabilities. To expand our previous study which demonstrated the short-term effects of an 8-week online MBT program, the present study investigated whether those short-term effects persist up to a month after the end of the intervention.Among previous participants, 56 (64%) participated in this follow-up study, 25 in the MBT group and 31 in the control group. Outcome measures included the stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression of both groups at baseline, at 8 weeks (right after the training or waiting period), and at 12 weeks (a month after the training or waiting period).The MBT group showed a greater decrease in stress response at 8 weeks, and this reduction remained a month after the end of the intervention. The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later. However, the improvement to emotional intelligence and negative affect did not persist a month after training.These findings suggest that the beneficial short-term effects of MBT may last beyond the training period even without continuous practice, but the retention of these benefits seems to depend on the outcome variables. Through a convenient, affordable, and easily accessible online format, MBT may provide cost-effective solutions for employees at worksites.",2020,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,['female healthcare providers'],"['MBT', 'online mind-body training program', 'Mind-body training']","['emotional intelligence', 'stress and psychological outcomes', 'stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression', 'resilience and effective coping strategies', 'stress response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2364069', 'cui_str': 'Able to cope'}]",,0.0207628,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,"[{'ForeName': 'Dasom', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Emotional Information and Communication Technology Association.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital.'}, {'ForeName': 'Soo-Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Joon-Hwan', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Emotional Information and Communication Technology Association.'}]",Medicine,['10.1097/MD.0000000000021027']
2421,32770859,Randomised clinical study: oral aspirin 325 mg daily vs placebo alters gut microbial composition and bacterial taxa associated with colorectal cancer risk.,"BACKGROUND


Aspirin is associated with decreased risk of colorectal cancer (CRC), potentially by modulating the gut microbiome.
AIMS


To evaluate the effect of aspirin on the gut microbiome in a double-blinded, randomised placebo-controlled pilot trial.
METHODS


Healthy volunteers aged 50-75 received a standard dose of aspirin (325 mg, N = 30) or placebo (N = 20) once daily for 6 weeks and provided stool samples every 3 weeks for 12 weeks. Serial measurements of gut microbial community composition and bacterial abundance were derived from 16S rRNA sequences. Linear discriminant analysis of effect size (LEfSe) was tested for between-arm differences in bacterial abundance. Mixed-effect regression with binomial distribution estimated the effect of aspirin use on changes in the relative abundance of individual bacterial taxa via an interaction term (treatment × time).
RESULTS


Over the study period, there were differences in microbial composition in the aspirin vs placebo arm. After treatment, four taxa were differentially abundant across arms: Prevotella, Veillonella, Clostridium XlVa and Clostridium XVIII clusters. Of pre-specified bacteria associated with CRC (n = 8) or aspirin intake (n = 4) in published studies, interactions were significant for four taxa, suggesting relative increases in Akkermansia, Prevotella and Ruminococcaceae and relative decreases in Parabacteroides, Bacteroides and Dorea in the aspirin vs placebo arm.
CONCLUSION


Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC. This suggests that aspirin may influence CRC development through an effect on the gut microbiome. The findings need replication in a larger trial. The study was registered using Clinical Trials Registration NCT02761486.",2020,"Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC.",['Healthy volunteers aged 50-75 received a'],"['placebo, aspirin', 'aspirin intake ', 'aspirin 325\xa0mg daily vs placebo', 'Aspirin', 'aspirin', 'standard dose of aspirin', 'placebo']","['Akkermansia, Prevotella and Ruminococcaceae and relative decreases in Parabacteroides, Bacteroides and Dorea', 'microbial composition and bacterial taxa associated with colorectal cancer risk', 'several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea', 'microbial composition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0992015', 'cui_str': 'Aspirin 325 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1212549', 'cui_str': 'Dorea'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",,0.618793,"Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC.","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Prizment', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Staley', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Guillaume C', 'Initials': 'GC', 'LastName': 'Onyeaghala', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Sithara', 'Initials': 'S', 'LastName': 'Vivek', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Thyagarajan', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Straka', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Demmer', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Meyer', 'Affiliation': 'Chapel Hill, NC, USA.'}, {'ForeName': 'Aasma', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sadowsky', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Church', 'Affiliation': 'Minneapolis, MN, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16013']
2422,32771369,Evaluation of a computerized contraceptive decision aid: A randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.
STUDY DESIGN


We conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.
RESULTS


We enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group.
CONCLUSIONS


Decisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.
IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.",2020,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","['women presenting for reversible contraception at two clinics affiliated with an academic medical center', 'women seeking reversible contraception', 'We enrolled and randomized 253 women, and 241 had complete data for our primary outcome']",['contraceptive decision aid'],"['contraceptive method chosen and satisfaction with the healthcare visit', 'change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale', 'decisional conflict score', 'decisional conflict, alter method choice, or impact satisfaction', 'median decisional conflict', 'Overall, pre-visit decisional conflict scores', 'decisional conflict']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",253.0,0.126585,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Madden', 'Affiliation': 'Divisions of Family Planning & Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63110, USA. Electronic address: maddent@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Holttum', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health, University of Minnesota Medical School, 515 Mayo Memorial Building, Moos Tower 12th Floor, Minneapolis, MN 55455, USA.""}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Maddipati', 'Affiliation': 'Brown School, Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO 63130, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Secura', 'Affiliation': 'Divisions of Family Planning & Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63110, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Nease', 'Affiliation': 'ExpressScripts, 1 Express Way, St. Louis, MO 63121, USA.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, 550 University Blvd, University Hospital 2440, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis School of Medicine, 660 S. Euclid, Campus Box 8100, St. Louis, MO 631110, USA.'}]",Contraception,['10.1016/j.contraception.2020.08.002']
2423,32771424,Evaluating the impact of the antrum size following laparoscopic sleeve gastrectomy: a randomized multicenter study.,"BACKGROUND


The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) remains discordant and highly related to the surgical technique. GERD and weight regain are probably understudied by prospective clinical studies depending on different technical factors.
OBJECTIVES


The purpose of this article is to evaluate the effect of extent to which the antrum is resected on GERD following LSG but also on early complications and short-term weight loss results.
SETTING


University Hospital, France.
METHODS


Patients were randomly assigned in group A (172 patients), LSG with antral resection, or group B (174 patients), LSG with antral preservation. The baseline characteristics collected were demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level.
RESULTS


A total of 279 patients underwent LSG and they were included in the final analysis. The GERD analyzed at 3 months postoperatively by pH-metry was observed for 57.8% in group A and for 52.4% of patients in group B (P = .4819). There was no statistically significant difference (P = .3755) between the 2 groups at 1 year after surgery (group A, 49.5% versus group B, 43.6%). The gastrin serum level was analyzed 1 year after surgery for a total of 107 patients. For group A, the mean gastrin level was 97.4 ± 85.9 pg/mL, which was inferior compared with group B (150.6 ± 152.4 pg/mL) with no statistical difference (P = .067). The recorded excess weight loss for group A was 79.67% (± 28.88) with no statistically significant difference with group B 74.46% (± 36.61) (P = .3678). The mortality rate was nil. We recorded 5 cases of staple line leakage (3 in group A and 2 in group B); 11 patients presented bleeding (3 in group A and 8 group B), and 4 patients presented with gastric stenosis (2 in group A and 2 in group B).
CONCLUSIONS


The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG. The only significant difference was achieved for nausea and vomiting symptoms, which were more significant for the antrum resection group. Further clinical trials with newer procedures will indicate the factors that can diminish the reflux following LSG. Furthermore, the conservation of a large part of the antrum may be helpful to convert the sleeve to another bariatric procedure (transit bipartition).",2020,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","['Patients were randomly assigned in group A (172 patients', '279 patients underwent LSG and they were included in the final analysis', 'University Hospital, France']","['LSG with antral resection', 'laparoscopic sleeve gastrectomy', 'LSG with antral preservation', 'laparoscopic sleeve gastrectomy (LSG']","['demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level', 'excess weight loss', 'GERD and weight regain', 'gastroesophageal reflux disease (GERD', 'mean gastrin level', 'nausea and vomiting symptoms', 'mortality rate', 'reflux, weight loss, or complications', 'bleeding', 'gastrin serum level', 'staple line leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0202036', 'cui_str': 'Gastrin measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",279.0,0.0340159,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nocca', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France; Université Montpellier 1, Montpellier, France. Electronic address: d-nocca@chu-montpellier.fr.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': ""Université Montpellier 1, Montpellier, France; Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Ion', 'Initials': 'I', 'LastName': 'Donici', 'Affiliation': 'CHU Nimes, Nimes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Emungania', 'Affiliation': 'CHU Hôpital Nord, Marseille, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jaussent', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Akouete', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France; ELSAN, Clinique Bouchard, Marseille, France.'}, {'ForeName': 'Anamaria', 'Initials': 'A', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.041']
2424,32779001,The effects of β 1  and β 1+2  adrenergic receptor blockade on the exercise-induced mobilization and ex vivo expansion of virus-specific T cells: implications for cellular therapy and the anti-viral immune effects of exercise.,"The adoptive transfer of donor-derived virus-specific T cells (VSTs) is an effective treatment for infections following allogeneic hematopoietic cell transplantation. Acute exercise mobilizes effector lymphocytes and VSTs to the circulation and augments the ex vivo manufacture of VSTs. This study determined if β 2  adrenergic receptor (AR) signaling precipitated the VST response to acute exercise. Healthy participants (n = 12) completed 30 min of steady-state cycling exercise after ingesting a placebo, a β 1 + 2  AR antagonist (nadolol) or a β 1  AR antagonist (bisoprolol). Circulating VSTs to cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV) antigens were enumerated before and after exercise, and peripheral blood mononuclear cells were cultured with viral peptides for 8 days to expand multi-VSTs. Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure. Circulating AdV and EBV VSTs (VSTs/mL blood) only increased after exercise with placebo. Although not significant, nadolol partially mitigated exercise-induced increases in multi-VST expansion, particularly in participants that demonstrated an exercise-induced increase in VST expansion. We conclude that exercise-induced enhancements in VST mobilization and expansion are at least partially β 2  AR mediated, thus highlighting a role for the β 2  AR in targeted therapy for the augmentation of VST immune cell therapeutics in the allogeneic adoptive transfer setting. Moreover, long-term regular exercise may provide additional viral protection in the host through frequent β 2  AR-dependent mobilization and redistribution of VSTs cumulated with each bout of exercise.",2020,"Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure.","['allogeneic hematopoietic cell transplantation', 'Healthy participants (n\u2009=\u200912) completed']","['placebo, nadolol', 'nadolol', '30\xa0min of steady-state cycling exercise after ingesting a placebo, a β 1\u2009+\u20092  AR antagonist (nadolol) or a β 1  AR antagonist (bisoprolol', 'adoptive transfer of donor-derived virus-specific T cells (VSTs', 'placebo']","['Circulating VSTs to cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV', 'exercise-induced mobilization of CMV-VSTs', 'VST expansion', 'exercising heart rate and blood pressure', 'Circulating AdV and EBV VSTs (VSTs/mL blood', 'multi-VST expansion']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0376518', 'cui_str': 'Adoptive Transfer'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.045439,"Compared with placebo, nadolol blunted the exercise-induced mobilization of CMV-VSTs (Δ VSTs/100,000 CD3 +  T cells = 93 ± 104 vs. 22 ± 91 for placebo and nadolol, respectively; p = 0.036), while bisoprolol did not, despite both drugs evoking similar reductions in exercising heart rate and blood pressure.","[{'ForeName': 'Hawley E', 'Initials': 'HE', 'LastName': 'Kunz', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Nadia H', 'Initials': 'NH', 'LastName': 'Agha', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Merced Experimental Social and Health Psychology Laboratory, Stress and Health Laboratory, Department of Psychological Sciences, University of California Merced, Merced, CA, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'LaVoy', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Preteesh', 'Initials': 'P', 'LastName': 'Mylabathula', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Douglass', 'Initials': 'D', 'LastName': 'Diak', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Forrest L', 'Initials': 'FL', 'LastName': 'Baker', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bond', 'Affiliation': 'College of Pharmacy, Science and Engineering Research Center, The University of Houston, Houston, TX, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katsanis', 'Affiliation': 'Department of Pediatrics, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Center for Cancer and Immunology Research, Children's Research Institute, Children's National Health System and The George Washington University, Washington, D.C., USA.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Simpson', 'Affiliation': 'Laboratory of Integrated Physiology, Department of Health and Human Performance, University of Houston, Houston, TX, USA. rjsimpson@email.arizona.edu.'}]",Cell stress & chaperones,['10.1007/s12192-020-01136-7']
2425,32769884,The therapeutic effect of repetitive transcranial magnetic stimulation in elderly depression patients.,"BACKGROUND


Depression, a common psychiatric disorder in elderly, serves as a remarkable precipitating factor for suicide among the elderly people. Here, a randomized double-blinded study was performed to investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on improving the clinical symptoms and reducing suicidal ideation in elderly patients with depression.
METHODS


In this study, 103 elderly patients with depression and suicidal ideation were randomly divided into 2 groups, 48 cases in the rTMS group and 55 cases in the control group (sham rTMS). Both groups received routine drug therapy with rTMS or sham rTMS. The patients received evaluation by Hamilton depression scale and self-rating idea of suicide scale before treatment and after 2 and 4 weeks of treatment, respectively.
RESULTS


The measurement from the present study demonstrated that Hamilton depression scale and self-rating idea of suicide scale scores decreased to varying degrees in the 2 groups after treatment, and the decrease was more significant in rTMS group. The rate of marked effectiveness was much higher in rTMS group after 2 weeks of treatment compared with the control group. Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
CONCLUSION


Together, the present study shows that rTMS with routine drug therapy exhibited effect with quick onset to improve the clinical symptoms and reduce suicidal ideation in elderly patients with depression.",2020,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","['elderly depression patients', 'elderly patients with depression', '103 elderly patients with depression and suicidal ideation']","['repetitive transcranial magnetic stimulation', 'rTMS', 'control group (sham rTMS', 'routine drug therapy with rTMS or sham rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['Hamilton depression scale and self-rating idea of suicide scale', 'rate of marked effectiveness', 'suicidal ideation', 'Hamilton depression scale and self-rating idea of suicide scale scores', 'rate of moderate effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",103.0,0.0269797,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","[{'ForeName': 'Lilei', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Jingmen Oral Hospital, Jingmen, Hubei, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Xinfu', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Luan', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}]",Medicine,['10.1097/MD.0000000000021493']
2426,32769888,Computer-navigated versus conventional total knee arthroplasty: A randomized controlled trial protocol in China.,"BACKGROUND


The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty (TKA) improves patients' activities of daily living or the durability of total knee prostheses. Thus, in this protocol, we designed a randomized controlled trial to compare implant alignment, functional scores, and survival of the implant using computer-assisted surgery versus a conventional surgical technique.
METHODS


This prospective, blinded randomized controlled trial was conducted at our single hospital. This study was approved by the ethics committee of Jiaxing Second Hospital. The patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35 kg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author. We randomized consented study participants on a 1:1 ratio to 1 of 2 study groups using a computer-generated list of random numbers in varying block sizes. The primary outcome in this study was the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant. Statistical significance was defined as a P value of ≤0.05.
CONCLUSIONS


Authors hypothesized that computer-assisted surgery in primary TKA improves implant alignment, functional scores, and survival of the implant compared to the conventional technique.",2020,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[""patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35\u200akg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author""]","['computer-navigated total knee arthroplasty (TKA', 'implant using computer-assisted surgery versus a conventional surgical technique', 'Computer-navigated versus conventional total knee arthroplasty']","['implant alignment, functional scores, and survival of the implant', 'Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant', 'Knee Injury and Osteoarthritis Outcome Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}]",,0.166324,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[{'ForeName': 'Yefeng', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of orthopedics, Jiaxing Second Hospital, Zhejiang Province, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021508']
2427,32779057,"Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.","BACKGROUND


Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.
METHODS


This phase 2/3, randomized, double-blind, placebo-controlled, dose-response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK + ) concentrations ≥ 5.1- ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK +  over 48 h. The proportion of patients with normokalemia (sK +  3.5-5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated.
RESULTS


Overall, 103 patients (mean age, 73.2 years; range 50-89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261 (SZC 5 g) and - 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK +   < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported.
CONCLUSION


SZC is effective and well tolerated in Japanese patients with hyperkalemia.",2020,The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261,"['adults in a number of countries, including Japan', 'Japanese adults with hyperkalemia', 'Patients with serum potassium (sK + ) concentrations\u2009≥\u20095.1', 'Japanese patients with hyperkalemia', '103 patients (mean age, 73.2\xa0years; range 50-89\xa0years']","['serum potassium with sodium zirconium cyclosilicate', 'SZC', 'Sodium zirconium cyclosilicate (SZC', 'SZC 5', 'placebo']","['efficacy and safety', 'exponential rate of sK +  change', 'Hypokalemia', 'exponential rate of change in sK +  over 48\xa0h']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",103.0,0.427485,The exponential rate of sK +  change from 0 to 48 h versus placebo was - 0.00261,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Nishio', 'Affiliation': 'Nephrology Dialysis Center, Kusatsu General Hospital, Shiga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Department of Internal Medicine, Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Saka', 'Affiliation': 'Department of Nephrology, Kasugai Municipal Hospital, Aichi, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Imasawa', 'Affiliation': 'Department of Nephrology, Chiba-Higashi Hospital, Chiba, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Ohtake', 'Affiliation': 'Department of Nephrology, Shonan Kamakura General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Nephrology, Inage Hospital, Chiba, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Shibagaki', 'Affiliation': 'Division of Nephrology and Hypertension, St. Marianna University School of Medicine Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sarai', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. nobuaki.sarai@astrazeneca.com.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01937-1']
2428,32772684,Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,"BACKGROUND AND PURPOSE


To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy.
METHODS


Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway.
RESULTS


The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23];  P  value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25),  P  value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118];  P  value: 0.067).
CONCLUSIONS


This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.",2020,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"['n=60 patients (CTT: n=34/60 [56.7 %]; DTAS', 'Patients Receiving Mechanical Thrombectomy', 'patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway', 'patients receiving']","['angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT', 'Direct Transfer to Angio-Suite Versus Computed Tomography-Transit', 'stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography', 'DTAS', 'computed-tomography scanner suite (CT-Transit [CTT']","['Time from imaging to groin puncture', 'Time from hospital admission to final angiographic reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.0900532,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herweh', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ulfert', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029905']
2429,32789480,Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial.,"Importance


The value of platinum-based adjuvant chemotherapy in patients with triple-negative breast cancer (TNBC) remains controversial, as does whether BRCA1 and BRCA2 (BRCA1/2) germline variants are associated with platinum treatment sensitivity.
Objective


To compare 6 cycles of paclitaxel plus carboplatin (PCb) with a standard-dose regimen of 3 cycles of cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T).
Design, Setting, and Participants


This phase 3 randomized clinical trial was conducted at 9 cancer centers and hospitals in China. Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled. Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy. Data were analyzed from December 1, 2019, to January 31, 2020, from the intent-to-treat population as prespecified in the protocol.
Interventions


Participants were randomized to receive PCb (paclitaxel 80 mg/m2 and carboplatin [area under the curve = 2] on days 1, 8, and 15 every 28 days for 6 cycles) or CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil 500 mg/m2 every 3 weeks for 3 cycles followed by docetaxel 100 mg/m2 every 3 weeks for 3 cycles).
Main Outcomes and Measures


The primary end point was disease-free survival (DFS). Secondary end points included overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity.
Results


A total of 647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC were randomized to receive CEF-T (n = 322) or PCb (n = 325). At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03). Similar outcomes were observed for distant DFS and relapse-free survival. There was no statistically significant difference in overall survival between the groups (HR = 0.71; 95% CI, 0.42-1.22, P = .22). In the exploratory and hypothesis-generating subgroup analyses of PCb vs CEF-T, the HR for DFS was 0.44 (95% CI, 0.15-1.31; P = .14) in patients with the BRCA1/2 variant and 0.39 (95% CI, 0.15-0.99; P = .04) in those with the HRR variant. Safety data were consistent with the known safety profiles of relevant drugs.
Conclusions and Relevance


These findings suggest that a paclitaxel-plus-carboplatin regimen is an effective alternative adjuvant chemotherapy choice for patients with operable TNBC. In the era of molecular classification, subsets of TNBC sensitive to PCb should be further investigated.
Trial Registration


ClinicalTrials.gov Identifier: NCT01216111.",2020,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","['patients with triple-negative breast cancer (TNBC', '647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC', '9 cancer centers and hospitals in China', 'Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled', 'patients with operable TNBC', 'Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy', 'Women With Triple-Negative Breast Cancer']","['docetaxel', 'CEF-T', 'paclitaxel-plus-carboplatin regimen', 'PCb', 'platinum-based adjuvant chemotherapy', 'CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil', 'PCb (paclitaxel 80 mg/m2 and carboplatin', 'Adjuvant Paclitaxel and Carboplatin', 'paclitaxel plus carboplatin (PCb', 'cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T']","['overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity', 'DFS time', 'overall survival', 'Survival', 'distant DFS and relapse-free survival', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4080545', 'cui_str': 'Cyclophosphamide 500 MG'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",647.0,0.405234,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","[{'ForeName': 'Ke-Da', 'Initials': 'KD', 'LastName': 'Yu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Fu-Gui', 'Initials': 'FG', 'LastName': 'Ye', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Cancer Prevention & Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Di', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Zeng', 'Affiliation': 'Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China.'}, {'ForeName': 'Ping-Qing', 'Initials': 'PQ', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ke-Jin', 'Initials': 'KJ', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Hou', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, The International Peace Maternity & Child Health Hospital of China Welfare Institute, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Zhuang', 'Affiliation': 'Department of Breast Surgery, Shanghai First Maternity and Infant Hospital, Shanghai Tongji University, Shanghai, China.'}, {'ForeName': 'Chuan-Gui', 'Initials': 'CG', 'LastName': 'Song', 'Affiliation': 'Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, Tongji University School of Medicine Yangpu Hospital, Shanghai, China.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Toss', 'Affiliation': 'Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Department of Drug Development and Innovation, Institute Curie, Paris & Saint-Cloud, France.'}, {'ForeName': 'Zhen-Zhou', 'Initials': 'ZZ', 'LastName': 'Shen', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2965']
2430,32773366,A Model of Intervention and Implementation of Quality Building and Quality Control in Childcare Centers to Strengthen the Mental Health and Development of 1-3-Year Olds: Protocol for a Randomized Controlled Trial of Thrive by Three.,"BACKGROUND


Universal, high-quality childcare offers a unique opportunity to prevent developmental trajectories leading to mental health problems. Yet, growing evidence has shown that the process quality of Norwegian childcare centers varies considerably, and that research-based models for quality building are significantly lacking.
OBJECTIVE


To examine whether a model for quality building in childcare centers, Thrive by Three, increases the quality of child-caregiver interactions, and promotes child development, well-being, and mental health.
METHODS


The Thrive by Three study is a clustered randomized controlled trial involving 187 toddler groups in childcare centers across 7 municipalities within southern and central Norway. Each center is randomly allocated to the intervention or wait-list control group. Data are collected at 4 points: preintervention (T1), midway (T2), postintervention (T3), and 1-year postintervention (T4). Primary outcomes are changes in childcare quality measured by the Classroom Assessment Scoring System toddler version (CLASS), Student-Teacher Relationship Scale, Short Form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF), and Child Behavior Checklist (parent report) from the Achenbach System of Empirically Based Assessment (ASEBA) from 1.5 to 5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D). Secondary outcomes are child cortisol levels, assessed in a subsample of 372 children.
RESULTS


As of August 2020, a total of 1531 children and 769 staff from 187 toddler groups were recruited. Because of turnover, the recruitment of staff will be ongoing until August 2020. As of January 2020, the intervention group has been working with Thrive by Three for 1.5 years. Data at T1, T2, and T3 from both the intervention and control groups have been completed and T4 will be completed in August 2020.
CONCLUSIONS


This study makes an important contribution to the field of quality building in childcare centers. The results will provide greater insight into how high quality can be obtained and the effects of high-quality early childcare on child mental health. This in turn will be significant for policymakers and to the Norwegian society at large.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03879733; https://clinicaltrials.gov/ct2/show/NCT03879733 and Norwegian Research Council 260624/H10; https://prosjektbanken.forskningsradet.no/#/project/NFR/260624/Sprak=en.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17726.",2020,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","['187 toddler groups in childcare centers across seven municipalities within southern and central Norway', 'childcare centers', 'As of November 2018, a total of 1531 children and 769 staff, from 187 toddler-groups were recruited']",['intervention or waitlist (control) group'],"[""changes in childcare quality measured by the Classroom Assessment Scoring System (CLASS) toddler version, Student-Teacher Relationship Scale short form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health, measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver-Teacher Report Form (C-TRF) and Child Behavior Checklist (CBCL, parent report) from the Achenbach ASEBA from 1.5-5 years, and child well-being measured by the Leiden Inventory for Child's Well-Being in Day Care (LICW-D"", 'Child cortisol levels']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",1531.0,0.0912925,"Data at T1, T2 and T3 from both the intervention and control group has been completed and T4 will be completed in June 2020.
","[{'ForeName': 'Ratib', 'Initials': 'R', 'LastName': 'Lekhal', 'Affiliation': 'Department of Communication and Culture, Norwegian Business School, Oslo, Norway.'}, {'ForeName': 'May Britt', 'Initials': 'MB', 'LastName': 'Drugli', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - Central Norway Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Turid Suzanne', 'Initials': 'TS', 'LastName': 'Berg-Nielsen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, Norway.'}, {'ForeName': 'Elisabet Solheim', 'Initials': 'ES', 'LastName': 'Buøen', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health Eastern and Southern Norway, Oslo, Norway.'}]",JMIR research protocols,['10.2196/17726']
2431,32783125,Functional Voice and Swallowing Outcome Analysis After Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach.,"BACKGROUND


The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a scarless remote-access thyroidectomy technique. This study compared subjective and objective voice outcomes and swallowing outcomes of patients who underwent thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT).
METHODS


In addition to questionnaires, acoustic and aerodynamic analyses were performed to compare subjective and objective voice outcomes of the two groups. Swallowing outcome analyses were conducted using Swallowing Impairment Index-6 (SIS-6) scores. Assessments were performed preoperatively and 3 and 6 months after surgery. Propensity score matching was performed to compare the outcomes of the two groups.
RESULTS


One hundred and two patients were included in this study (52 TOETVA and 50 OT). Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys. There were no significant differences between the groups in VAS, GRBAS, or VHI-10 scores at the preoperative and 3- and 6-month assessments. For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period. The TOETVA group had lower SIS-6 scores at the postoperative 6-month assessment, but the SIS-6 scores after 12 months were similar between groups before and after propensity score matching.
CONCLUSIONS


Following TOETVA lobectomy, there were no significant changes in voice outcomes 3 and 6 months after surgery, and the outcomes were comparable with those of OT. The TOETVA group also had swallowing outcomes that were comparable with the OT group.",2020,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","['Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys', 'patients who underwent', 'One hundred and two patients were included in this study (52 TOETVA and 50 OT']","['thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT', 'transoral endoscopic thyroidectomy vestibular approach (TOETVA', 'Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach']","['Functional Voice and Swallowing Outcome Analysis', 'lower SIS-6 scores', 'Swallowing Impairment Index-6 (SIS-6) scores', 'VAS, GRBAS, or VHI-10 scores', 'SIS-6 scores', 'subjective and objective voice outcomes', 'swallowing outcomes', 'subjective and objective voice outcomes and swallowing outcomes', 'acoustic or aerodynamic parameters', 'voice outcomes']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",102.0,0.0264362,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Tack-Kyun', 'Initials': 'TK', 'LastName': 'Kwon', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Chai', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea. kevinjoon1@gmail.com.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Doh Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital and College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hoon Yub', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, KUMC Thyroid Center, Korea University Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Tae', 'Initials': 'KT', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Ka Hee', 'Initials': 'KH', 'LastName': 'Yi', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}]",World journal of surgery,['10.1007/s00268-020-05731-8']
2432,32783178,Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials.,"PURPOSE


This analysis evaluated the relationship between treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival (OS, in PALOMA-3), treatment effect in patients with bone-only disease, and whether intrinsic subtype affects PFS in patients receiving palbociclib.
METHODS


Data were from phase 3, randomized PALOMA-2 and PALOMA-3 clinical studies of hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+ /HER2-) advanced breast cancer (ABC) patients receiving endocrine therapy plus palbociclib or placebo. Subpopulation treatment effect pattern plot (STEPP) analysis evaluated the association between DFI and PFS and OS. PFS by luminal subtype and cyclin-dependent kinase (CDK) 4/6 or endocrine pathway gene expression levels were evaluated in patients with bone-only disease; median PFS and OS were estimated by the Kaplan-Meier method.
RESULTS


Median durations of TFI were 37.1 and 30.9 months (PALOMA-2) and DFI were 49.2 and 52.0 months (PALOMA-3) in the palbociclib and placebo groups, respectively. Among the PALOMA-2 biomarker population (n = 454), 23% had bone-only disease; median PFS was longer with palbociclib versus placebo (31.3 vs 11.2 months; hazard ratio, 0.41; 95% CI 0.25‒0.69). The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262). Among the PALOMA-3 biomarker population (n = 302), 27% had bone-only disease. STEPP analyses showed that palbociclib PFS benefit was not affected by DFI, and that palbociclib OS effect may be smaller in patients with short DFIs. Among patients who provided metastatic tumor tissues (n = 142), regardless of luminal A (hazard ratio, 0.23; 95% CI 0.11‒0.47; P = 0.0000158) or luminal B (hazard ratio, 0.26; 95% CI 0.12‒0.56; P = 0.000269) subtype, palbociclib improved PFS versus placebo.
CONCLUSIONS


These findings support palbociclib plus endocrine therapy as standard of care for HR+ /HER2- ABC patients, regardless of baseline TFI/DFI or intrinsic molecular subtype, including patients with bone-only disease.
TRIAL REGISTRATION


Pfizer (clinicaltrials.gov:NCT01740427, NCT01942135).",2020,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"['advanced breast cancer (ABC) patients receiving', 'patients with short DFIs', 'patients with bone-only disease']","['palbociclib plus endocrine therapy', 'endocrine therapy plus palbociclib or placebo', 'plot (STEPP', 'hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+\u2009/HER2', 'placebo']","['bone-only disease; median PFS', 'DFI and PFS and OS', '4/6 or endocrine pathway gene expression levels', 'bone-only disease', 'median PFS with palbociclib', 'PFS by luminal subtype and cyclin-dependent kinase (CDK', 'treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival', 'Median durations of TFI', 'palbociclib PFS benefit']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.323609,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, 710 N Fairbanks Ct, Suite 8-250A, Chicago, IL, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, Ismaninger Str 22, 81675, Munich, Germany.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, 675 West 10th Ave, Vancouver, BC, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giorgetti', 'Affiliation': 'Pfizer Italia, Via Anna Maria Mozzoni, 12, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, 525 Market Street, San Francisco, CA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, PA, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, Fulham Rd, London, SW3 6JJ, UK.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Center, 1600 Divisadero St, San Francisco, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05782-4']
2433,32790108,Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy.,"AIMS


Response to cardiac resynchronization therapy (CRT) is known to be associated with a number of clinical characteristics, including QRS duration and morphology, gender, height, and the aetiology of heart failure (HF). We assessed the relation of gender and baseline characteristics with QRS duration and Kansas City Cardiomyopathy Questionnaire.
METHODS AND RESULTS


AdaptResponse is a global randomized trial. The trial enrolled CRT-indicated patients with New York Heart Association classes II-IV HF, left bundle branch block (QRS ≥ 140 ms in men, ≥130 ms in women), and baseline PR interval ≤200 ms. In total, 3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population. Women were older and more often New York Heart Association class III or IV than men (55.6% vs. 48.7%), had less frequent ischaemic cardiomyopathy (21.2% vs. 39.5%), and had a 5.1 ms shorter QRS duration than men. Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
CONCLUSIONS


AdaptResponse is the largest randomized CRT trial and enrolled more women than any other landmark CRT trial. Women differed from men with regard to baseline characteristics and quality of life. Whether these differences translate into clinical outcome differences will be examined further in the AdaptResponse trial.",2020,"Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
","['men and women undergoing cardiac resynchronization therapy', '3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population', 'patients with New York Heart Association classes II-IV HF, left bundle branch block (QRS\xa0≥\xa0140\xa0ms in men, ≥130\xa0ms in women), and baseline PR interval ≤200\xa0ms']",['cardiac resynchronization therapy (CRT'],"['quality of life', 'frequent ischaemic cardiomyopathy', 'Kansas City Cardiomyopathy Questionnaire score', 'QRS duration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",3620.0,0.226255,"Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions.
","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Department of Cardiology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Hersi', 'Affiliation': 'Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Gerritse', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Department of Cardiology, University of Rennes, Rennes, France.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium and Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",ESC heart failure,['10.1002/ehf2.12914']
2434,32773226,Effect of Ezetimibe + Pitavastatin on Cardiovascular Outcomes in Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study).,"Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate the effect of intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe, on patients with STEMI. We therefore undertook a post hoc subanalysis of the HIJ-PROPER study's data that examined the clinical outcomes of the patients with dyslipidemia and STEMI (n = 880) who received pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group), and we evaluated their cardiovascular events. The primary end point was a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization. During the median 3.4-year follow-up period, the cumulative rates of the primary end point were 31.9% and 39.7% in the intensive lipid-lowering therapy and standard lipid-lowering therapy groups, respectively (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62 to 0.97; p = 0.02). Compared with the standard lipid-lowering therapy group, the intensive lipid-lowering therapy group had significantly lower all-cause death (6.9% vs 3.2%; HR, 0.45; 95% CI, 0.23 to 1.84; p = 0.01) and nonfatal stroke (2.9% vs 1.6%; HR, 0.77; 95% CI, 0.62 to 0.97; p = 0.02) rates. Patients with pitavastatin and ezetimibe therapy, as compared with pitavastatin monotherapy, had a lower cardiovascular event in STEMI patients. In conclusion, adding ezetimibe to statin therapy may be beneficial for patients with dyslipidemia and STEMI.",2020,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"['Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study', 'patients with dyslipidemia and STEMI', 'patients with dyslipidemia and STEMI (n\u202f=\u202f880) who received', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI']","['intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe', 'Lipid-lowering therapy', 'pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group', 'ezetimibe', 'pitavastatin and ezetimibe therapy', 'Ezetimibe\u202f+\u202fPitavastatin', 'pitavastatin monotherapy', 'standard lipid-lowering therapy']","['cumulative rates', 'cause death', 'cardiovascular event rates', 'nonfatal stroke', 'Cardiovascular Outcomes', 'composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",880.0,0.0372168,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"[{'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.069']
2435,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
2436,32790051,The effect of symptom-tracking apps on symptom reporting.,"OBJECTIVE


The use of health apps is increasing worldwide, with a common feature being daily symptom tracking. However, symptom tracking has been shown to increase symptom reporting. This study investigated whether using a menstrual-monitoring app with a symptom-tracking feature increases symptom reporting compared to an app without this feature or no app at all.
DESIGN


Experimental study.
METHODS


Ninety-one participants were randomly allocated to use either a menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group. The number of period-related symptoms as well as general symptom reporting was assessed at baseline prior to group allocation and then 1 and 4 months later. The change in the proportion of people classified as high symptom reporters was also examined.
RESULTS


We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010). At the 4-month time point, significantly more participants in the symptom-tracking group were now classified as high period symptom reporters (baseline 50%, 4 months 70%, p = .031), while the other two groups did not change from baseline. There were no differences in general symptom reporting across the three groups.
CONCLUSION


A period-monitoring app with a symptom tracker may increase the reporting of period symptoms. This effect does not appear to generalize to broader symptom reporting. Further research is needed to support these findings and to examine the impact of symptom-tracking apps on daily functioning and health anxiety. Statement of contribution What is already known on this subject? The experience of transient symptoms is common in day-to-day life. These symptoms often do not have an underlying cause or are a sign of illness. Actively tracking symptoms has been shown to result in greater symptom reporting, symptom severity, and slower recovery from injury. The use of health apps is increasing, with a common feature being symptom tracking. Menstrual-monitoring apps, in particular, frequently require users to track symptoms. What does this study add? Using a menstrual-monitoring app with a symptom tracker for 4 months increases the number of period-specific symptoms reported compared a basic calendar app. A greater proportion of people were now classified as high period symptom reporters after using the symptom-tracking app. These effects do not seem to generalize to broader non-specific symptom reporting.",2020,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).",['Ninety-one participants'],"['menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group']","['number of period-related symptoms', 'number of period-specific symptoms', 'period-related symptoms', 'general symptom reporting']","[{'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449955', 'cui_str': 'Number of periods'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}]",91.0,0.0449667,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'MacKrill', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Groom', 'Affiliation': 'Liggins Institute, University of Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}]",British journal of health psychology,['10.1111/bjhp.12459']
2437,32784117,Idebenone does not inhibit disability progression in primary progressive MS.,"BACKGROUND


Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disorder of the central nervous system (CNS). While current MS therapies target the inflammatory processes, no treatment explicitly targets mitochondrial dysfunction and resulting axonal loss. Therefore, the aim of this study was to determine whether idebenone inhibits mitochondrial dysfunction and accumulation of disability in primary progressive MS (PPMS) and to enhance understanding of pathogenic mechanisms of PPMS progression using cerebrospinal fluid (CSF) biomarkers.
METHODS


The double-blind, placebo-controlled Phase I/II clinical trial of Idebenone in patients with Primary Progressive MS (IPPoMS; NCT00950248) was an adaptively designed, baseline-versus-treatment, placebo-controlled, CSF-biomarker-supported trial. Based on interim analysis of the 1-year pre-treatment data, change in the area under the curve of Combinatorial Weight-Adjusted Disability Score (CombiWISE) became the primary outcome, with >80% power to detect ≥40% efficacy with 28 patients/arm treated for 2 years in baseline versus treatment paradigm. Changes in traditional disability scales and in brain ventricular volume were secondary outcomes. Exploratory outcomes included CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning.
RESULTS


Idebenone was well tolerated but did not inhibit disability progression or CNS tissue destruction. Concentrations of GDF15, secreted predominantly by astrocytes and choroid plexus epithelium in vitro, increased after exposure to mitochondrial toxin rotenone, validating the ability of this biomarker to measure intrathecal mitochondrial damage. CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS. Idebenone did not change CSF GDF15 levels.
CONCLUSION


Mitochondrial dysfunction exceeding normal aging reflected by age-adjusted CSF GDF15 is present in the majority of PPMS patients, but it is not inhibited by idebenone.",2020,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","['patients with Primary Progressive MS (IPPoMS', 'primary progressive MS (PPMS']","['Idebenone', 'idebenone', 'placebo']","['Mitochondrial dysfunction', 'traditional disability scales', 'CSF levels of GDF15', 'CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning', 'CSF GDF15 levels', 'Combinatorial Weight-Adjusted Disability Score (CombiWISE', 'disability progression or CNS tissue destruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0123163', 'cui_str': 'idebenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}]",,0.0721347,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kosa', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical trials Unit, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Santhera Pharmaceuticals (Switzerland) AG, Pratteln Switzerland.'}, {'ForeName': 'Ruturaj', 'Initials': 'R', 'LastName': 'Masvekar', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wichman', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sandford', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Bielekova', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: Bibi.Bielekova@nih.gov.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102434']
2438,32778721,Acute increases in brain-derived neurotrophic factor following high or moderate-intensity exercise is accompanied with better cognition performance in obese adults.,"The purpose of this study was to test if different intensities of aerobic exercise could influence abdominal fat, isoforms of BDNF and executive function. Twenty obese men (30.0 ± 5.4 years old; 34.4 ± 3.5 kg/m 2 ) were randomized to moderate-intensity continuous training (MICT, n = 10) and high-intensity intermittent training (HIIT, n = 10) three times a week for 6 weeks, with isoenergetic energetic expenditure for each exercise session (~ 300 kcal) between conditions. Abdominal fat was assessed pre- and post-intervention; executive function (Coding subtest from BETA-III non-verbal intelligence test and Stroop Color and Word Test), concentrations of mBDNF and proBDNF were assessed in response to acute exercise pre- and post-intervention. Abdominal fat did not change in either group. There was a significant increase in mBDNF immediately after acute exercise in both groups before and after intervention. proBDNF did not present changes acutely nor after 6 weeks. Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups. In conclusion, executive function improvements and acute exercise session-induced increases in mBDNF concentration were found from pre- to post-exercise intervention similarly between MICT and HIIT in obese men.",2020,"Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups.","['obese men', 'Twenty obese men (30.0\u2009±\u20095.4\xa0years old; 34.4\u2009±\u20093.5\xa0kg/m 2 ', 'obese adults']","['pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session', 'moderate-intensity continuous training (MICT, n\u2009=\u200910) and high-intensity intermittent training (HIIT, n\u2009=\u200910) three times a week for 6\xa0weeks, with isoenergetic energetic expenditure for each exercise session', 'proBDNF', 'aerobic exercise']","['mBDNF concentration', 'abdominal fat, isoforms of BDNF and executive function', 'Abdominal fat was assessed pre- and post-intervention; executive function (Coding subtest from BETA-III non-verbal intelligence test and Stroop Color and Word Test), concentrations of mBDNF and proBDNF', 'mBDNF', 'Abdominal fat', 'cognition performance']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021705', 'cui_str': 'Intelligence test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",20.0,0.0297667,"Executive function presented a main effect of time at pre- and post-intervention time-points Stroop Word and Stroop Color and Coding subtest presented improved performance from pre- to post-acute exercise session, in both groups.","[{'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil. dsinoue@gmail.com.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Priscilla Rodrigues', 'Initials': 'PR', 'LastName': 'Santana', 'Affiliation': 'Psychology Department, Universidade São Judas Tadeu and Fundação Santo André, São Paulo, Brazil.'}, {'ForeName': 'Fernando Pierin', 'Initials': 'FP', 'LastName': 'Peres', 'Affiliation': 'Medicine Department, Universidade Do Oeste Paulista, São Paulo, Brazil.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Charles Perkins Centre, Faculty of Health Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, School of Technology and Sciences, State University (UNESP), Presidente Prudente, São Paulo, Brazil. fabio.lira@unesp.br.'}]",Scientific reports,['10.1038/s41598-020-70326-1']
2439,32780610,Role of low-molecular-weight heparin in altering uterine artery blood flow in recurrent spontaneous abortion: a prospective study.,"OBJECTIVE


This study aimed to determine the role of uterine artery blood flow (UABF) in recurrent spontaneous abortion (RSA) and to determine a viable option to promote the outcome of pregnancy.
METHODS


A total of 421 women were prospectively recruited for this research. UABF indices, including the systolic/diastolic ratio, pulsatility index and resistance index, during the midluteal phase were compared between patients with RSA and women without RSA (controls). After low-molecular-weight heparin (LMWH) was administered to patients with RSA, indices at 7, 10, and 12 weeks of gestation were compared between the two groups.
RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group. After LMWH was administered to the RSA group, UABF indices in the first trimester were similar to those in the control group. The rate of spontaneous miscarriage was also similar between the groups after LMWH treatment.
CONCLUSIONS


Our study shows that sufficient uterine perfusion is crucial for a successful pregnancy. LMWH reduces the rate of spontaneous miscarriage in patients with RSA to a similar rate in women without RSA. LMWH might play a role in decreasing UABF resistance and increasing uterine perfusion.",2020,"RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group.","['recurrent spontaneous abortion', 'recurrent spontaneous abortion (RSA', 'A total of 421 women were prospectively recruited for this research', 'patients with RSA']","['LMWH', 'RSA', 'low-molecular-weight heparin (LMWH', 'uterine artery blood flow (UABF', 'low-molecular-weight heparin']","['rate of spontaneous miscarriage', 'uterine artery blood flow', 'UABF indices', 'systolic/diastolic ratio, pulsatility index and resistance index', 'UABF resistance']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",421.0,0.0464912,"RESULTS


UABF indices during the midluteal phase were significantly higher in the RSA group than in the control group.","[{'ForeName': 'Kemei', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Ensheng', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Jiaou', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Ultrosonic Department, Ningbo First Hospital, Zhejiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Reproductive Medicine Centre, Ningbo First Hospital, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060520945558']
2440,32788743,Efficacy and safety of continuous antiviral therapy from preconception to prevent perinatal transmission of hepatitis B virus.,"Few studies were conducted to assess safety and efficacy of continuous antiviral therapy administrated from preconception. In the present study, 136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB) (Group A, B or C) or chronic HBV carrier (Group D). Antiviral therapy was administrated in preconception (Group A), in early (Group B) or late pregnancy (Group C and Group D). Immunoprophylaxis was administrated to all infants. Mothers' HBV status and ALT were assessed at delivery and 7 months postpartum. Offspring's HBV status was examined at 7 months old. Group A women showed low HBV DNA level and normal ALT throughout pregnancy. All women at delivery had an HBV DNA level of less than 10 6  IU/ml, but the proportion of patients with lower HBV DNA level in Group A was higher than any of other three groups (P < 0.05). No differences in obstetrical complications were found among the four groups. None of infants who completed follow-up showed positive HBsAg at age of 7 months. Congenital malformation and infant growth indicators were similar among study cohorts. Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.",2020,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"['136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB', 'active CHB mothers and their infants']","['Antiviral therapy', 'Immunoprophylaxis', 'continuous antiviral therapy']","['low HBV DNA level and normal ALT', 'positive HBsAg', 'Congenital malformation and infant growth indicators', 'HBV DNA level', 'Efficacy and safety', 'obstetrical complications', 'safety and efficacy', ""Mothers' HBV status and ALT""]","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0520463', 'cui_str': 'Chronic active hepatitis'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",136.0,0.0306027,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"[{'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jingsi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Fetal Medicine and Prenatal Diagnosis, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Yifen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Huishu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Guocheng', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangdong Provincial Maternal and Children's Hospital, Guangzhou, China.""}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing TsingHua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Guanxin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of Immunology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Dunjin', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangzhou, China. gzdrchen@gzhmu.edu.cn.'}]",Scientific reports,['10.1038/s41598-020-70644-4']
2441,32785213,Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.,"In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 , a pandemic. With rapidly accumulating numbers of cases and deaths reported globally 2 , a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.",2020,RBD-binding IgG concentrations and SARS-CoV-2,"['45 healthy adults, 18 to 55 years of age', 'adults']","['COVID-19 RNA vaccine BNT162b1', 'lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD']","['Geometric mean neutralizing titers', 'Local reactions and systemic events', 'RBD-binding IgG concentrations and SARS-CoV-2', 'reactogenicity', 'neutralizing titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",45.0,0.183612,RBD-binding IgG concentrations and SARS-CoV-2,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}]",Nature,['10.1038/s41586-020-2639-4']
2442,32783554,Detection and False-Referral Rates of 2-mSv CT Relative to Standard-Dose CT for Appendiceal Perforation: Pragmatic Multicenter Randomized Controlled Trial.,"OBJECTIVE.  The objective of our study was to compare diagnostic performance of 2-mSv CT and standard-dose CT (SDCT) for the diagnosis of perforated appendicitis in adolescents and young adults.  MATERIALS AND METHODS.  We used the intention-to-treat analysis set of a pragmatic randomized controlled trial involving 3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals. The patients were randomized to undergo either 2-mSv CT or SDCT. Predefined endpoints were sensitivity and specificity. Considering potential verification bias caused by the difference in diagnostic interventions (2-mSv CT vs SDCT), we added endpoints of detection rate (DR) and false-referral rate. The reference standards were surgical or pathologic findings. We used Fisher exact tests. Sensitivity analyses included the following: first, a per-protocol analysis; second, an analysis of a surgical reference standard but not a pathologic reference standard; and, third, an analysis to adjust for site clustering. We tested for heterogeneity in DR and false-referral rate across various patient and hospital characteristics.  RESULTS.  The 2-mSv CT and SDCT groups were comparable regarding DR (5.1% [78/1535] vs 4.9% [76/1539]; 95% CI for the difference, -1.4 to 1.7 percentage points;  p  = 0.87), false-referral rate (3.1% [48/1535] vs 3.1% [47/1539]; 95% CI for the difference, -1.2 to 1.3 percentage points;  p  = 0.92), sensitivity (42.9% [78/182] vs 43.2% [76/176]; 95% CI for the difference, -10.6 to 9.9 percentage points;  p  > 0.99), and specificity (89.2% [305/342] vs 91.2% [354/388]; 95% CI for the difference, -6.4 to 2.3 percentage points;  p  = 0.38). Sensitivity analyses showed similar results. We found no significant subgroup heterogeneity.  CONCLUSION.  The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.",2020,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","['3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals', 'adolescents and young adults']","['2-mSv CT and standard-dose CT (SDCT', 'SDCT', '2-mSv CT or SDCT', '2-mSv CT Relative to Standard-Dose CT']","['diagnostic performance', 'detection rate (DR) and false-referral rate', 'false-referral rate', 'sensitivity', 'specificity', 'sensitivity and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",3074.0,0.282225,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22632']
2443,32784625,Prescriber Commitment Posters to Increase Prudent Antibiotic Prescribing in English General Practice: A Cluster Randomized Controlled Trial.,"Unnecessary antibiotic prescribing contributes to Antimicrobial Resistance posing a major public health risk. Estimates suggest as many as half of antibiotics prescribed for respiratory infections may be unnecessary. We conducted a three-armed unblinded cluster randomized controlled trial (ISRCTN trial registry 83322985). Interventions were a commitment poster (CP) advocating safe antibiotic prescribing or a CP plus an antimicrobial stewardship message (AM) on telephone appointment booking lines, tested against a usual care control group. The primary outcome measure was antibiotic item dispensing rates per 1000 population adjusted for practice demographics. The outcome measures for post-hoc analysis were dispensing rates of antibiotics usually prescribed for upper respiratory tract infections and broad spectrum antibiotics. In total, 196 practice units were randomized to usual care ( n  = 60), CP ( n  = 66), and CP&AM ( n  = 70). There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458; CP&AM, -12.575, 95%CI -30.726 to 5.576,  p  = 0.167). Secondary analysis, which included pooling the data into one model, showed a significant effect of the AM (-18.444, 95%CI -32.596 to -4.292,  p  = 0.012). Fewer penicillins and macrolides were prescribed in the CP&AM intervention compared to usual care (-12.996, 95% CI -34.585 to -4.913,  p  = 0.018). Commitment posters did not reduce antibiotic prescribing. An automated patient antimicrobial stewardship message showed effects and requires further testing.",2020,"There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458;",['196 practice units'],"['CP plus an antimicrobial stewardship message (AM', 'CP&AM intervention']","['dispensing rates of antibiotics usually prescribed for upper respiratory tract infections and broad spectrum antibiotics', 'overall dispensing rates', 'antibiotic item dispensing rates per 1000 population adjusted for practice demographics']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.134725,"There was no effect on the overall dispensing rates for either interventions compared to usual care (CP 5.673, 95%CI -9.768 to 21.113,  p  = 0.458;","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Bondaronek', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Jet G', 'Initials': 'JG', 'LastName': 'Sanders', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Harris', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'The Behavioural Insights Team. 4 Matthew Parker St, Westminster, London SW1H 9NP, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tonkin-Crine', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights (PHEBI), Research, Translation & Innovation, Public Health England, Wellington House, 133-155 Waterloo Rd, Lambeth, London SE1 8UG, UK.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9080490']
2444,32773484,The effect of universal testing and treatment on HIV stigma in 21 communities in Zambia and South Africa.,"OBJECTIVES


To assess the impact of a combination HIV prevention intervention including universal testing and treatment (UTT) on HIV stigma among people living with HIV, and among community members and health workers not living with HIV.
DESIGN


This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013 and 2018 in 21 urban/peri-urban communities (12 in Zambia and nine in South Africa).
METHODS


Using an adjusted two-stage cluster-level analysis, controlling for baseline imbalances, we compared multiple domains of stigma between the trial arms at 36 months. Different domains of stigma were measured among three cohorts recruited across all study communities: 4178 randomly sampled adults aged 18-44 who were living with HIV, and 3487 randomly sampled adults and 1224 health workers who did not self-report living with HIV.
RESULTS


Prevalence of any stigma reported by people living with HIV at 36 months was 20.2% in arm A, 26.1% in arm B, and 19.1% in arm C (adjusted prevalence ratio, A vs. C 1.01 95% CI 0.49-2.08, B vs. C 1.34 95% CI 0.65-2.75). There were no significant differences between arms in any other measures of stigma across all three cohorts. All measures of stigma reduced over time (0.2--4.1% reduction between rounds) with most reductions statistically significant.
CONCLUSION


We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV. Stigma reduced over time, but slowly. CLINICALTRIALS.
GOV NUMBER


NCT01900977.",2020,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","['three cohorts recruited across all study communities: 4,178 randomly sampled adults aged 18-44 who were living with HIV, and 3,487 randomly sampled adults and 1,224 health workers who did not self-report living with HIV', '21 communities in Zambia and South Africa', 'This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013-2018 in 21\u200aurban/peri-urban communities (12 in Zambia and 9 in South Africa', 'people living with HIV, and among community members and health workers not living with HIV']","['universal testing and treatment', 'combination HIV prevention intervention including universal testing and treatment (UTT']","['stigma', 'HIV stigma']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",4178.0,0.520195,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Stangl', 'Affiliation': 'International Center for Research on Women, Washington, DC.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Tila', 'Initials': 'T', 'LastName': 'Mainga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Steinhaus', 'Affiliation': 'International Center for Research on Women, Washington, DC.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mubekapi-Musadaidzwa', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Lario', 'Initials': 'L', 'LastName': 'Viljoen', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Dunbar', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nomtha', 'Initials': 'N', 'LastName': 'Mandla', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Department of Infectious Disease, Imperial College, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'SCHARP, Seattle, Washington, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002658']
2445,32788051,Lack of effect on ambulation of dalfampridine-ER (4-AP) treatment in adult SMA patients.,"SMA is a genetically determined motor system disorder that results in muscle weakness, selective motor neuron death, muscle atrophy, and impaired functional mobility. In SMA model systems, long-term treatment with 4-aminopyridine (4-AP) has been shown to improve motor function. To assess tolerability and preliminary efficacy of 4-AP on walking ability, endurance and EMG in adult ambulatory SMA patients, we conducted a double blind, placebo control, crossover pilot study with dalfampridine (4-AP, 10 mg BID). The study is comprised of a short-term (2 weeks) treatment arm with 1-week washout and a long-term (6 weeks) treatment arm with a 2-week washout. The primary outcome measure, for which the study was powered, was the 6 min walk test (6MWT, distance and percent fatigue); secondary outcome measures were the Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses. We performed electrophysiology, including CMAP and H-reflex, during the short-term treatment trial. The mean age of the 11 participants enrolled was 37.7 ± 11.9 years; 54.5% were male. Dalfampridine was safe and well tolerated and no patient suffered a serious adverse event related to treatment. We observed no statistically significant positive effects of dalfampridine treatment on our primary functional motor outcome (6MWT distance, fatigue). Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude. The effect on the H-reflex is of interest, as it suggests dalfampridine may enhance neuronal activity, an effect observed in SMA Drosophila and mouse models at doses (mg/kg) not recommended for clinical use. Larger studies with dalfampridine in SMA patients are needed to confirm our findings, especially in light of studies in other populations showing drug effects in only a subset of patients.",2020,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"['The mean age of the 11 participants enrolled was 37.7\u202f±\u202f11.9 years; 54.5% were male', 'SMA patients', 'adult ambulatory SMA patients', 'adult SMA patients']","['SMA', '4-AP', 'Dalfampridine', 'dalfampridine (4-AP, 10\u202fmg BID', '4-aminopyridine (4-AP', 'dalfampridine', 'dalfampridine-ER (4-AP', 'placebo']","['functional motor outcome (6MWT distance, fatigue', '6\xa0min walk test (6MWT, distance and percent fatigue', 'walking ability, endurance and EMG', 'H-reflex and H/M ratio', 'Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses', 'safe and well tolerated']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0335933', 'cui_str': 'Hammersmith'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0085106', 'cui_str': 'Familial benign pemphigus'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",11.0,0.104935,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"[{'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'Chiriboga', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States. Electronic address: cac3@cumc.columbia.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marra', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'LaMarca', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Sally Dunaway', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Neurology, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Weimer', 'Affiliation': 'Department of Neurology, Columbia College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McCabe', 'Affiliation': 'Brain Mind Institute, EPFL, Lausanne, Switzerland.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.07.007']
2446,32794176,Lung volume changes in Apnoeic Oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) compared to mechanical ventilation in adults undergoing laryngeal surgery.,"BACKGROUND


Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) using high-flow 100% oxygen during apnoea has gained increased use during difficult airway management and laryngeal surgery due to a slower carbon dioxide rise compared to traditional apnoeic oxygenation. We have previously demonstrated high arterial oxygen partial pressures and an increasing arterial-alveolar carbon dioxide difference during THRIVE. Primary aim of this study was to characterise lung volume changes measured with electrical impedance tomography during THRIVE compared to mechanical ventilation.
METHODS


Thirty adult patients undergoing laryngeal surgery under general anaesthesia were randomised to THRIVE or mechanical ventilation. Subjects were monitored with electrical impedance tomography and repeated blood gas measurement perioperatively. The THRIVE group received 100% oxygen at 70 l min -1  during apnoea. The mechanical ventilation group was intubated and normoventilated with an FiO 2  of 0.4.
RESULTS


Mean age were 48.2 (19.9) and 51.3 (12.3) years, and BMI 26.0 (4.5) and 26.0 (3.9) in the THRIVE and mechanical ventilation group respectively. Mean apnoea time in the THRIVE group was 17.9 (4.8) min. Mean apnoea to end-of-surgery time was 28.1 (12.8) min in the mechanical ventilation group. No difference in delta End Expiratory Lung Impedance was seen between groups over time. In the THRIVE group all but three subjects were well oxygenated during apnoea. THRIVE was discontinued for the three patients who desaturated.
CONCLUSIONS


No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.",2020,"No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.","['adults undergoing laryngeal surgery', 'Thirty adult patients undergoing laryngeal surgery under general anaesthesia', 'Mean age were 48.2 (19.9) and 51.3 (12.3) years, and BMI 26.0 (4.5) and 26.0 (3.9) in the THRIVE and mechanical ventilation group, respectively']","['mechanical ventilation', 'THRIVE or mechanical ventilation', 'Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE', 'electrical impedance tomography and repeated blood gas measurement perioperatively']","['arterial oxygen partial pressures', 'arterial-alveolar carbon dioxide difference', 'Mean apnoea to end-of-surgery time', 'Mean apnoea time', 'delta End Expiratory Lung Impedance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}]",30.0,0.0464048,"No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.","[{'ForeName': 'Ida-Maria', 'Initials': 'IM', 'LastName': 'Forsberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ullman', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Medical School, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars I', 'Initials': 'LI', 'LastName': 'Eriksson', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Lodenius', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Malin J', 'Initials': 'MJ', 'LastName': 'Fagerlund', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13686']
2447,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
2448,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
2449,32780660,Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial.,"PURPOSE


Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events).
METHODS


Patients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected.
RESULTS


Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank  P  < .0001; median, 24.0  v  11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4  v  9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031];  P  = .69).
CONCLUSION


Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.",2020,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049).","['Patients with ALK inhibitor-naive advanced ALK-positive NSCLC', 'Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138', 'Non-Small Cell Lung Cancer']","['brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily', 'Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive']","['Brigatinib delayed median time to worsening of global health status/QoL scores', 'superior progression-free survival (PFS) and improved health-related quality of life (QoL', 'Brigatinib daily area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C4530661', 'cui_str': 'brigatinib 180 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3204577', 'cui_str': 'crizotinib 250 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",275.0,0.347815,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank  P  = .049).","[{'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'James C H', 'Initials': 'JCH', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Delmonte', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'García Campelo', 'Affiliation': 'Complejo Hospitalario Universitario A Coruna, Coruna, Spain.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius-Hospital Oldenburg, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'The Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Cancer Specialists and US Oncology Research, The Woodlands, TX.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Huamao M', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hanley', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Ni', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00505']
2450,32780661,"Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China.","PURPOSE


No randomized trials have compared hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT) after breast-conserving surgery in the Asian population. This study aimed to determine whether a 3.5-week schedule of HFRT is noninferior to a standard 6-week schedule of CFRT in China.
PATIENTS AND METHODS


Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study. Patients were randomly assigned (1:1) using a computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation, followed by tumor-bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks with a boost of 10 Gy in five fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks with a boost of 8.7 Gy in three daily fractions (HFRT). The primary endpoint was 5-year local recurrence (LR), and a 5% margin of 5-year LR was used to establish noninferiority.
RESULTS


Between August 2010 and November 2015, 734 patients were assigned to the HFRT (n = 368) or CFRT (n = 366) group. At a median follow-up of 73.5 months (interquartile range, 60.5-91.4 months), the 5-year cumulative incidence of LR was 1.2% in the HFRT group and 2.0% in the CFRT group (hazard ratio, 0.62; 95% CI, 0.20 to 1.88;  P  = .017 for noninferiority). There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
CONCLUSION


CFRT and HFRT with a tumor-bed boost may have similar low LR and toxicity.",2020,"There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
","['734 patients were assigned to the', 'Between August 2010 and November 2015', 'After Breast-Conserving Surgery in the Modern Treatment Era', 'breast-conserving surgery in the Asian population', 'Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study']","['Hypofractionated Versus Conventional Fractionated Radiotherapy', 'CFRT', 'hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT', 'HFRT', 'computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation']","['5-year local recurrence (LR), and a 5% margin of 5-year LR', 'grade 2-3 acute skin toxicity', 'acute and late toxicities', 'low LR and toxicity', '5-year cumulative incidence of LR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",734.0,0.283661,"There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P  = .019).
","[{'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Xiang-Hui', 'Initials': 'XH', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yu-Chao', 'Initials': 'YC', 'LastName': 'Ma', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Lu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shu-Nan', 'Initials': 'SN', 'LastName': 'Qi', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Guang-Yi', 'Initials': 'GY', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xin-Fan', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01024']
2451,32780739,"The effect of an airflow restriction mask (ARM) on metabolic, ventilatory, and electromyographic responses to continuous cycling exercise.","This study analyzed the physiological adjustments caused by the use of the Elevation training mask® (2.0), an airflow restriction mask (ARM) during continuous exercise. Eighteen physically active participants (12 men and 6 women) were randomized to two protocols: continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE). Exercise consisted of cycling for 20 minutes at 60% of maximum power. Metabolic variables, lactate, and gas concentration were obtained from arterialized blood samples at pre and post exercise. Continuous expired gases and myoelectric activity of the quadriceps were performed at rest and during the test. We observed no reduction in oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit (all p <0.05). The expired gas analysis shows that the CE-ARM condition presented higher oxygen uptake and expired carbon dioxide concentrations (p <0.05). The CE-ARM condition also presented lower ventilatory volume, ventilatory frequency, and expired oxygen pressure (p <0.05). No changes in electromyography activity and lactate concentrations were identified. We conclude that using ARM does not induce hypoxia and represents an additional challenge for the control of acid-base balance, and we suggest the use of ARM as being suitable for respiratory muscle training.",2020,No changes in electromyography activity and lactate concentrations were identified.,['Eighteen physically active participants (12 men and 6 women'],"['airflow restriction mask (ARM', 'Elevation training mask® (2.0), an airflow restriction mask (ARM', 'continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE', 'continuous cycling exercise']","['metabolic, ventilatory, and electromyographic responses', 'Metabolic variables, lactate, and gas concentration', 'electromyography activity and lactate concentrations', 'oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit', 'oxygen uptake and expired carbon dioxide concentrations', 'ventilatory volume, ventilatory frequency, and expired oxygen pressure']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0728725', 'cui_str': 'Low pH'}, {'cui': 'C0860713', 'cui_str': 'Carbon dioxide increased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428653', 'cui_str': 'Carbon dioxide concentration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",18.0,0.0240789,No changes in electromyography activity and lactate concentrations were identified.,"[{'ForeName': 'João Francisco', 'Initials': 'JF', 'LastName': 'Barbieri', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Arthur Fernandes', 'Initials': 'AF', 'LastName': 'Gáspari', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Cassia Lopes', 'Initials': 'CL', 'LastName': 'Teodoro', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Motta', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Luz Albany Arcila', 'Initials': 'LAA', 'LastName': 'Castaño', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research (GEDAE-USP), School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celene Fernandes', 'Initials': 'CF', 'LastName': 'Bernades', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mara Patrícia Traina', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Antonio Carlos', 'Initials': 'AC', 'LastName': 'de Moraes', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}]",PloS one,['10.1371/journal.pone.0237010']
2452,32797232,A Randomized Comparative Trial of Targeted Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection for the Treatment of Unilateral Cervical Radicular Pain: Six-Month Results.,"OBJECTIVES


Compare the effectiveness of catheter-directed cervical interlaminar epidural steroid injection (C-CIESI) with triamcinolone to cervical transforaminal steroid injection (CTFESI) with dexamethasone for the treatment of refractory unilateral radicular pain.
DESIGN


Prospective, randomized, comparative trial.
METHODS


Primary outcome: proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain"" (the greater of arm vs neck) at one month postinjection. Secondary outcomes: ≥30% Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved.""
RESULTS


One hundred twenty participants (55.6% females, 52.3 ± 12.5 years of age, BMI 28.2 ± 6.5 kg/m2), were enrolled. The proportions of participants who experienced ≥50% pain reduction at one, three, and six months were 68.5% (95% CI = 54.9-79.5%), 59.3% (95% CI = 45.7-71.6%), and 60.8% (95% CI = 46.7-73.2%), respectively, in the C-CIESI group compared with 49.1% (95% CI = 36.4-62.0%), 46.4% (95% CI = 33.8-59.6%), and 51.9% (95% CI = 38.4-65.2%), respectively, in the CTFESI group. The between-group difference at one month was significant (P = 0.038). The proportions of participants who experienced a ≥30% NDI-5 score improvement were 64.0% (95% CI = 49.8-76.1%) and 54.9% (95% CI = 41.1-68.0%) in the C-CIESI and CTFESI groups (P = 0.352). Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
CONCLUSIONS


Both C-CIESI with triamcinolone and CTFESI with dexamethasone are effective in reducing pain and disability associated with refractory unilateral cervical radiculopathy in a substantial proportion of participants for at least six months.",2020,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","['One hundred twenty participants (55.6% females, 52.3\u2009±\u200912.5\u2009years of age, BMI 28.2\u2009±\u20096.5\u2009kg/m2), were enrolled', 'Unilateral Cervical Radicular Pain']","['triamcinolone', 'catheter-directed cervical interlaminar epidural steroid injection (C-CIESI', 'dexamethasone', 'triamcinolone and CTFESI with dexamethasone', 'Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection']","['NDI-5 score improvement', 'pain reduction', 'pain and disability', 'PGIC improvement', 'Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved', 'proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}]","[{'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",120.0,0.176804,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Conger', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Beau P', 'Initials': 'BP', 'LastName': 'Sperry', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Petersen', 'Affiliation': 'Alabama College of Osteopathic Medicine, Dothan, Alabama.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Salazar', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Michael Henrie', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kendall', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa242']
2453,32795925,Relationship between antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate.,"PURPOSE


To elucidate the relationship between antofloxacin (AT) plasma concentration and QT interval prolongation, compare the effects of different correction and analytical methods on conclusions, and estimate the possible false-positive rate in thorough QT (TQT) studies.
METHODS


Twenty-four healthy Chinese volunteers from a four-period crossover TQT study orally received 200 mg/d AT, 400 mg/d AT, 400 mg/d moxifloxacin, and a placebo in a random order for 5 d for each. QT interval samples were collected on d 1 and d 5. Population models were established describing the relationship between QT and AT concentration. The yardstick from ICH E14 guidelines was used to measure the effect of drugs on QT prolongation both in biostatistical and modeling analyses. A possible false-positive rate was estimated by constructing a 1000-time bootstrap to obtain the rate-of-difference values between d 1 and d 5 over 5 ms in the placebo period.
RESULTS


In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation. The estimation for the false-positive rate was 31 % in this study.
CONCLUSION


The effect of AT on QT interval prolongation may not have been significant at the dosage of 400 mg. Baseline and placebo adjustments were necessary in TQT studies. Population modeling has demonstrated clear superiority in making full use of data to accurately analyze the relationship between drugs and QT intervals.",2020,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.",['Twenty-four healthy Chinese volunteers from a four-period crossover'],"['TQT study orally received 200\u2009mg/d AT, 400\u2009mg/d AT, 400\u2009mg/d moxifloxacin, and a placebo', 'placebo']","['false-positive rate', 'antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate', 'antofloxacin (AT) plasma concentration and QT interval prolongation', 'QT interval samples', 'QT interval prolongation']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",24.0,0.0861305,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.","[{'ForeName': 'Li-Yu', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'He', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Feng-Yan', 'Initials': 'FY', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Lu-Jin', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ji-Han', 'Initials': 'JH', 'LastName': 'Huang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: huangjihan@shutcm.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: kunwang@139.com.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: qingshan.zheng@drugchina.net.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110619']
2454,32794334,Prognostic value of MRI-determined cervical lymph node size in nasopharyngeal carcinoma.,"OBJECTIVES


To investigate the prognostic value of magnetic resonance imaging (MRI)-determined cervical lymph node (CLN) size in nasopharyngeal carcinoma (NPC).
METHODS


We retrospectively reviewed 2066 patients with NPC treated with intensity-modulated radiotherapy, and randomly divided them into two groups, in a 1:1 ratio. One group was used for training (the training group), and the other one was for internal validation (the validation group). All patients had undergone MRI examination and the maximal axial diameters (MAD) of the axial plane of all positive nodes had been measured and recorded.
RESULTS


Of 683 patients with CLN metastases in the training group (n = 1033), MAD = 4 cm was associated with worse OS (64.7% vs 84.6%, P < .001), DFS (55.9% vs 76.3%, P = .001), and DMFS (67.6% vs 86.1%, P = .001). Multivariate analysis showed that MAD = 4 cm was a significant negative prognostic factor for OS (HR = 2.058; P = .025), DFS (HR = 1.727; P = .049), and DMFS (HR = 2.034; P = .036). When MRI-determined MAD = 4 cm was classified as N3 in the N classification, the OS, DFS, DMFS, and RRFS survival curves were well separated. The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
CONCLUSION


MAD = 4 cm on axial MRI slices can be recommended as a prognostic factor in future versions of the UICC/AJCC NPC staging system.",2020,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","['683 patients with CLN metastases in the training group (n\xa0=\xa01033', '2066 patients with NPC treated with intensity-modulated', 'nasopharyngeal carcinoma', 'nasopharyngeal carcinoma (NPC']","['radiotherapy', 'magnetic resonance imaging (MRI)-determined cervical lymph node (CLN']","['DFS', 'undergone MRI examination and the maximal axial diameters (MAD', 'DMFS', 'OS, DFS, DMFS, and RRFS concordance indexes', 'worse OS', 'OS, DFS, DMFS, and RRFS survival curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0254792', 'cui_str': 'ribosome releasing factor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2066.0,0.0325976,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","[{'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Liu', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3392']
2455,32792098,Artificial neural network model for preoperative prediction of severe liver failure after hemihepatectomy in patients with hepatocellular carcinoma.,"BACKGROUND


Posthepatectomy liver failure is a worrisome complication after major hepatectomy for hepatocellular carcinoma and is the leading cause of postoperative mortality. Recommendations for hepatectomy for hepatocellular carcinoma are based on the risk of severe posthepatectomy liver failure, and accurately predicting posthepatectomy liver failure risk before undertaking major hepatectomy is of great significance. Thus, herein, we aimed to establish and validate an artificial neural network model to predict severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy.
METHODS


Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included. We randomly divided the patients into a development set (n = 265, 75%) and a validation set (n = 88, 25%). Multivariate logistic analysis facilitated identification of independent variables that we incorporated into the artificial neural network model to predict severe posthepatectomy liver failure in the development set and then verified in the validation set.
RESULTS


The morbidity of patients with severe posthepatectomy liver failure in the development and validation sets was 24.9% and 23.9%, respectively. Multivariate analysis revealed that platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant were all significant predictors of severe posthepatectomy liver failure. Incorporating these factors, the artificial neural network model showed satisfactory area under the receiver operating characteristic curve for the development set of 0.880 (95% confidence interval, 0.836-0.925) and for the validation set of 0.876 (95% confidence interval, 0.801-0.950) in predicting severe posthepatectomy liver failure and achieved well-fitted calibration ability. The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems. Moreover, stratification into 3 risk groups highlighted significant differences between the incidences and grades of posthepatectomy liver failure.
CONCLUSION


The artificial neural network model accurately predicted the risk of severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy. Our artificial neural network model might help surgeons identify intermediate and high-risk patients to facilitate earlier interventions.",2020,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"['Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma who underwent hemihepatectomy']","['artificial neural network model', 'Artificial neural network model']","['platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant', 'morbidity of patients with severe posthepatectomy liver failure']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087350', 'cui_str': 'Hemihepatectomy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}]",353.0,0.0387042,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"[{'ForeName': 'Rong-Yun', 'Initials': 'RY', 'LastName': 'Mai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Department of Experimental Research, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Hua-Ze', 'Initials': 'HZ', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liang', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Bang-de', 'Initials': 'BD', 'LastName': 'Xiang', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Le-Qun', 'Initials': 'LQ', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Jia-Zhou', 'Initials': 'JZ', 'LastName': 'Ye', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. Electronic address: yejiazhou2019@163.com.'}]",Surgery,['10.1016/j.surg.2020.06.031']
2456,32792099,The clinical outcomes of endovenous microwave and laser ablation for varicose veins: A prospective study.,"BACKGROUND


This study investigates the clinical outcomes of endovenous microwave ablation and endovenous laser ablation for varicose veins.
METHODS


A total of 139 patients who underwent endovenous microwave ablation and 145 patients who underwent endovenous laser ablation were included in this multicenter study. The clinical outcomes and complications were assessed at 1, 6, and 12 months after the procedure. The effect on quality of life was assessed by the Aberdeen Varicose Vein Questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire.
RESULTS


The endovenous microwave ablation group had a shorter procedure time than the endovenous laser ablation group (42.58 ± 15.62 minutes vs 65.46 ± 24.38 minutes, P < .01), and no significant differences were observed in the other procedure parameters. The incidences of induration (20.26% vs 31.06%) and ecchymosis (13.07% vs 22.98%, P < .05) were lower in the endovenous microwave ablation group. The rates of temporary paresthesia (9.80% vs 18.01%) and residual varicosities (8.61% vs 16.77%, P < .05) were lower in the endovenous microwave ablation group at 1 month. There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months. Both groups had significant improvements in their Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores post-procedure, and no significant differences in Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores were confirmed. However, local recurrence below the knee was lower in the endovenous microwave ablation group (2.34% vs 8.46%, P < .05) after 12 months.
CONCLUSION


Our results confirmed that the endovenous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endovenous laser ablation procedure.",2020,There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months.,"['and 145 patients who underwent', '139 patients who underwent', 'varicose veins']","['endovenous microwave ablation', 'endovenous microwave and laser ablation', 'endovenous laser ablation', 'endovenous microwave ablation and endovenous laser ablation']","['quality of life', 'local recurrence below the knee', 'incidences of induration', 'shorter procedure time, lower complication, and local recurrence', 'rates of temporary paresthesia', 'shorter procedure time', 'residual varicosities', 'paresthesia or saphenous vein closure rates', 'Aberdeen Varicose Vein Questionnaire and EuroQol Group 5-Dimension Self-Report Questionnaire scores', 'ecchymosis']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",139.0,0.017454,There were no significant differences in paresthesia or saphenous vein closure rates between the groups at 6 and 12 months.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: jdvascs@163.com.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated TCM-WM Surgery, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chenghua', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Department of Ultrasound Medicine, Nanjing Lishui People's Hospital, Nanjing, China.""}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Vascular Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}]",Surgery,['10.1016/j.surg.2020.06.035']
2457,32325004,Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in  De Novo  Respiratory Failure. A Pilot Study.,"Rationale:  The role of inspiratory effort still has to be determined as a potential predictor of noninvasive mechanical ventilation (NIV) failure in acute hypoxic  de novo  respiratory failure. Objectives:  To explore the hypothesis that inspiratory effort might be a major determinant of NIV failure in these patients. Methods:  Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled. Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate were recorded on admission and 2-4 to 12-24 hours after NIV start and were tested for correlation with outcomes. Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5 [30-36] cm H 2 O;  P  < 0.0001), whereas other variables differed later. ΔPes was not related to other predictors of NIV failure at baseline. NIV-induced reduction in ΔPes of 10 cm H 2 O or more after 2 hours of treatment was strongly associated with avoidance of intubation and represented the most accurate predictor of treatment success (odds ratio, 15; 95% confidence interval, 2.8-110;  P  = 0.001 and area under the curve, 0.97; 95% confidence interval, 0.91-1;  P  < 0.0001). Conclusions:  The magnitude of inspiratory effort relief as assessed by ΔPes variation within the first 2 hours of NIV was an early and accurate predictor of NIV outcome at 24 hours.Clinical trial registered with www.clinicaltrials.gov (NCT03826797).",2020,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5",['Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled'],[],"['Noninvasive Ventilation Outcome', 'ΔPes and ΔPes/ΔPl ratio', 'Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",30.0,0.374853,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tonelli', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fantini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tabbì', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Castaniere', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Pellegrino', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Della Casa', 'Affiliation': 'Radiology Unit and.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Statistics Unit, Department of Diagnostics, Clinical and Public Health Medicine, and.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Intensive Care Unit, Department of Surgical, Medical, Dental and Morphological Sciences related to Transplants Oncology and Regenerative Medicine, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy; and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nava', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marchioni', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2512OC']
2458,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance


Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting.
Objective


To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD.
Interventions


Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks.
Design, Setting, and Participants


The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate.
Main Outcomes and Measures


Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed.
Results


A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred.
Conclusions and Relevance


In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134']
2459,32804205,Effect of High-Dose Erythropoietin on Blood Transfusions in Extremely Low Gestational Age Neonates: Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Extremely preterm infants are among the populations receiving the highest levels of transfusions. Erythropoietin has not been recommended for premature infants because most studies have not demonstrated a decrease in donor exposure.
Objectives


To determine whether high-dose erythropoietin given within 24 hours of birth through postmenstrual age of 32 completed weeks will decrease the need for blood transfusions.
Design, Setting, and Participants


The Preterm Erythropoietin Neuroprotection Trial (PENUT) is a randomized, double-masked clinical trial with participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States. Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days). Exclusion criteria included conditions known to affect neurodevelopmental outcomes. Of 3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to erythropoietin (n = 477) or placebo (n = 464). Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019.
Interventions


In this post hoc analysis, erythropoietin, 1000 U/kg, or placebo was given every 48 hours for 6 doses, followed by 400 U/kg or sham injections 3 times a week through postmenstrual age of 32 weeks.
Main Outcomes and Measures


Need for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level are presented herein.
Results


A total of 936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g. Erythropoietin treatment (vs placebo) decreased the number of transfusions (unadjusted mean [SD], 3.5 [4.0] vs 5.2 [4.4]), with a relative rate (RR) of 0.66 (95% CI, 0.59-0.75); the cumulative transfused volume (mean [SD], 47.6 [60.4] vs 76.3 [68.2] mL), with a mean difference of -25.7 (95% CI, 18.1-33.3) mL; and donor exposure (mean [SD], 1.6 [1.7] vs 2.4 [2.0]), with an RR of 0.67 (95% CI, 0.58-0.77). Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001). Of 936 infants, 160 (17.1%) remained transfusion free at the end of 12 postnatal weeks, including 43 in the placebo group and 117 in the erythropoietin group (P < .001).
Conclusions and Relevance


These findings suggest that high-dose erythropoietin as used in the PENUT protocol was effective in reducing transfusion needs in this population of extremely preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT01378273.",2020,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","['Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days', '936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g', '3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to', 'Extremely Low Gestational Age Neonates', 'participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States', 'Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019']","['Erythropoietin treatment (vs placebo', 'High-Dose Erythropoietin', 'erythropoietin', 'Erythropoietin', 'placebo']","['Measures\n\n\nNeed for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level', 'number of transfusions', 'Blood Transfusions', 'transfusion free', 'hematocrit levels', 'cumulative transfused volume']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",936.0,0.764264,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Neonatal-Perinatal Medicine, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Arkansas, Little Rock.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neonatal Medicine, Methodist Children's Hospital, San Antonio, Texas.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""Department of Neonatology, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City.'}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""Department of Neonatal Medicine, Maria Fareri Children's Hospital at Westchester, Valhalla, New York.""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Shea"", 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Department of Neonatology, Children's Minnesota, St Paul.""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Prentice Women's Hospital, Chicago, Illinois.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ohls', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of the University of Illinois, Chicago.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': 'Department of Neonatology, South Miami Hospital, South Miami, Florida.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""Department of Neonatology, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2271']
2460,32793485,Increased Dose to Organs in Urinary Tract Associates With Measures of Genitourinary Toxicity in Pooled Voxel-Based Analysis of 3 Randomized Phase III Trials.,"Purpose:  Dose information from organ sub-regions has been shown to be more predictive of genitourinary toxicity than whole organ dose volume histogram information. This study aimed to identify anatomically-localized regions where 3D dose is associated with genitourinary toxicities in healthy tissues throughout the pelvic anatomy.  Methods and Materials:  Dose distributions for up to 656 patients of the Trans-Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar CT dataset. Voxel- based multiple comparison permutation dose difference testing, Cox regression modeling and LASSO feature selection were used to identify regions where 3D dose-increase was associated with late grade ≥ 2 genitourinary dysuria, incontinence and frequency, and late grade ≥ 1 haematuria. This was externally validated by registering dose distributions from the RT01 (up to  n  = 388) and CHHiP (up to  n  = 247) trials onto the same exemplar and repeating the voxel-based tests on each of these data sets. All three datasets were then combined, and the tests repeated.  Results:  Voxel-based Cox regression and multiple comparison permutation dose difference testing revealed regions where increased dose was correlated with genitourinary toxicity. Increased dose in the vicinity of the membranous and spongy urethra was associated with dysuria for all datasets. Haematuria was similarly correlated with increased dose at the membranous and spongy urethra, for the RADAR, CHHiP, and combined datasets. Some evidence was found for the association between incontinence and increased dose at the internal and external urethral sphincter for RADAR and the internal sphincter alone for the combined dataset. Incontinence was also strongly correlated with dose from posterior oblique beams. Patients with fields extending inferiorly and posteriorly to the CTV, adjacent to the membranous and spongy urethra, were found to experience increased frequency.  Conclusions:  Anatomically-localized dose-toxicity relationships were determined for late genitourinary symptoms in the urethra and urinary sphincters. Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",2020,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",[],['CHHiP'],"['Haematuria', 'genitourinary toxicity', 'Incontinence']",[],[],"[{'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",,0.0218456,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Medical Research Council, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}]",Frontiers in oncology,['10.3389/fonc.2020.01174']
2461,32791973,"Nicotinamide riboside with pterostilbene (NRPT) increases NAD +  in patients with acute kidney injury (AKI): a randomized, double-blind, placebo-controlled, stepwise safety study of escalating doses of NRPT in patients with AKI.","BACKGROUND


Preclinical studies have identified both NAD +  and sirtuin augmentation as potential strategies for the prevention and treatment of AKI. Nicotinamide riboside (NR) is a NAD +  precursor vitamin and pterostilbene (PT) is potent sirtuin activator found in blueberries. Here, we tested the effect of combined NR and PT (NRPT) on whole blood NAD +  levels and safety parameters in patients with AKI.
METHODS


We conducted a randomized, double-blind, placebo-controlled study of escalating doses of NRPT in 24 hospitalized patients with AKI. The study was comprised of four Steps during which NRPT (5 subjects) or placebo (1 subject) was given twice a day for 2 days. NRPT dosing was increased in each Step: Step 1250/50 mg, Step 2500/100 mg, Step 3750/150 mg and Step 41,000/200 mg. Blood NAD +  levels were measured by liquid chromatography-mass spectrometry and safety was assessed by history, physical exam, and clinical laboratory testing.
RESULTS


AKI resulted in a 50% reduction in whole blood NAD +  levels at 48 h compared to 0 h in patients receiving placebo (p = 0.05). There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment. Considering all Steps together, NRPT treatment increased NAD +  levels by 37% at 48 h compared to 0 h (p = 0.002). All safety laboratory tests were unchanged by NRPT treatment, including creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts. Three of 20 patients receiving NRPT reported minor gastrointestinal side effects.
CONCLUSION


NRPT increases whole blood NAD +  levels in hospitalized patients with AKI. In addition, NRPT up to a dose of 1000 mg/200 mg twice a day for 2 days is safe and well tolerated in these patients. Further studies to assess the potential therapeutic benefit of NRPT in AKI are warranted.
TRIAL REGISTRATION


NCT03176628 , date of registration June 5th, 2017.",2020,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","['patients with AKI', '20 patients receiving', '24 hospitalized patients with AKI', 'hospitalized patients with AKI', 'patients with acute kidney injury (AKI']","['Nicotinamide riboside (NR', 'NAD +  precursor vitamin and pterostilbene (PT', 'Nicotinamide riboside with pterostilbene (NRPT', 'combined NR and PT (NRPT', 'NRPT', 'placebo']","['Blood NAD +  levels', 'whole blood NAD +  levels', 'blood NAD +  levels', 'whole blood NAD +  levels and safety parameters', 'gastrointestinal side effects', 'safe and well tolerated', 'NAD +  levels', 'creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0664965', 'cui_str': 'pterostilbene'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}]",24.0,0.374567,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Simic', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. psimic@partners.org.'}, {'ForeName': 'Xavier Fernando', 'Initials': 'XF', 'LastName': 'Vela Parada', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dellinger', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'Guarente', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'Rhee', 'Affiliation': 'Department of Biology, Massachusetts Institute of Technology, Cambridge, MA, USA.'}]",BMC nephrology,['10.1186/s12882-020-02006-1']
2462,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
2463,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
2464,32800815,Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years.,"OBJECTIVE


To compare the effect of intervention at low vs high threshold of ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability.
STUDY DESIGN


This multicenter randomized controlled trial reviewed lumbar punctures initiated after either a low threshold (ventricular index of >p97 and anterior horn width of >6 mm) or high threshold (ventricular index of >p97 + 4 mm and anterior horn width of >10 mm). The composite adverse outcome was defined as death or cerebral palsy or Bayley composite cognitive/motor scores <-2 SDs at 24 months corrected age.
RESULTS


Outcomes were assessed in 113 of 126 infants. The composite adverse outcome was seen in 20 of 58 infants (35%) in the low threshold group and 28 of 55 (51%) in the high threshold (P = .07). The low threshold intervention was associated with a decreased risk of an adverse outcome after correcting for gestational age, severity of intraventricular hemorrhage, and cerebellar hemorrhage (aOR, 0.24; 95% CI, 0.07-0.87; P = .03). Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference, -0.06; 95% CI, -0.09 to -0.03; P < .001) at term-equivalent age. Infants in the low threshold group with a ventriculoperitoneal shunt, had cognitive and motor scores similar to those without (P = .3 for both), whereas in the high threshold group those with a ventriculoperitoneal shunt had significantly lower scores than those without a ventriculoperitoneal shunt (P = .01 and P = .004, respectively).
CONCLUSIONS


In a post hoc analysis, earlier intervention was associated with a lower odds of death or severe neurodevelopmental disability in preterm infants with progressive posthemorrhagic ventricular dilatation.
TRIAL REGISTRATION


ISRCTN43171322.",2020,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","['preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability', 'Posthemorrhagic Ventricular Dilatation', 'preterm infants with progressive posthemorrhagic ventricular dilatation']","['LT intervention', 'Late Ventricular Intervention Study (ELVIS']","['death or severe neurodevelopmental disability', 'intraventricular hemorrhage and cerebellar hemorrhage', 'cognitive and motor scores', 'risk of an adverse outcome', 'composite adverse outcome', 'death or cerebral palsy or Bayley composite cognitive/motor scores <-2 standard deviations', 'smaller fronto-occipital horn ratio']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0648185', 'cui_str': 'glutamyl-leucyl-valyl-isoleucyl-serine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0149854', 'cui_str': 'Cerebellar hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0152282', 'cui_str': 'Structure of posterior horn of lateral ventricle'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.200645,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","[{'ForeName': 'Mehmet N', 'Initials': 'MN', 'LastName': 'Cizmeci', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands; Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Kian D', 'Initials': 'KD', 'LastName': 'Liem', 'Affiliation': ""Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, the Netherlands.""}, {'ForeName': 'Ingrid C', 'Initials': 'IC', 'LastName': 'van Haastert', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': ""Department of Neonatology, 'Puerta del Mar' University Hospital, Cadiz, Spain.""}, {'ForeName': 'Henrica L M', 'Initials': 'HLM', 'LastName': 'van Straaten', 'Affiliation': ""Department of Neonatology, Isala Women and Children's Hospital, Zwolle, the Netherlands.""}, {'ForeName': 'Sylke', 'Initials': 'S', 'LastName': 'Steggerda', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Bert J', 'Initials': 'BJ', 'LastName': 'Smit', 'Affiliation': 'Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Woerdeman', 'Affiliation': 'Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heep', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands. Electronic address: l.s.devries@umcutrecht.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.014']
2465,32800818,Survivors of Intensive Care With Type 2 Diabetes and the Effect of Shared-Care Follow-Up Clinics: The SWEET-AS Randomized Controlled Pilot Study.,"BACKGROUND


Follow-up clinics after ICU admission have demonstrated limited benefit. However, existing trials have evaluated heterogeneous cohorts and used physicians who had limited training in outpatient care.
RESEARCH QUESTION


What are the effects of a ""shared-care"" intensivist-endocrinologist clinic for ICU survivors with type 2 diabetes on process measures and clinical outcomes 6 months after hospital discharge, and is it feasible to conduct a larger trial?
STUDY DESIGN AND METHODS


This was a prospective, randomized, single-center pilot study with blinded outcome assessment. Patients with type 2 diabetes, who required ≥ 5 days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge, were eligible. Participants were randomized to attendance at the shared-care clinic 1 month after hospital discharge or usual care. Six months after hospital discharge, participants were assessed for outcomes including glycated hemoglobin, neuropathy, nephropathy, quality of life (QoL), return to employment, frailty, and health-care use. The primary outcome was participant recruitment and retention.
RESULTS


During an 18-month period, 42 of 82 eligible patients (51%) were recruited. Four participants (10%) withdrew before assessment at 6 months and 11 (26%) died. At 6 months, only 18 of 38 participants who did not withdraw (47%) were living independently without support, and 24 (63%) required at least one subsequent hospital admission. In the intervention group (n = 21), 16 (76%) attended the clinic. Point estimates did not indicate that the intervention improved glycated hemoglobin (+5.6 mmol/mol; 95% CI, -6.3 to 17; P = .36) or quality of life (36-Item Short Form Survey physical summary score, 32 [9] vs. 32 [7]; P = 1.0).
INTERPRETATION


Outcomes for ICU survivors with type 2 diabetes are poor. Because of low participation and high mortality, a larger trial of a shared-care follow-up clinic in this cohort, using the present design, does not appear feasible.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry (ANZCTR); No.: ACTRN12616000206426; URL: www.anzctr.org.au.",2020,"Point estimates did not indicate that the intervention improved glycated hemoglobin [+5.6 mmol/mol, 95% CI -6.3 to 17; P=0.36] or QoL [Short Form-36 physical summary score 32 (9) vs. 32 (7); P=1.0].
","['and Methods', 'Participants were randomized to attendance at the shared-care clinic one month after hospital discharge or usual care', '42 of 82 (51%) eligible patients were recruited', 'Survivors of intensive care with type 2 diabetes', 'Patients with type 2 diabetes, who required ≥ 5 days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge were eligible']",[],"['participant recruitment and retention', 'glycated hemoglobin', 'glycated hemoglobin, neuropathy, nephropathy, quality of life (QoL), return to employment, frailty and healthcare utilization']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.125569,"Point estimates did not indicate that the intervention improved glycated hemoglobin [+5.6 mmol/mol, 95% CI -6.3 to 17; P=0.36] or QoL [Short Form-36 physical summary score 32 (9) vs. 32 (7); P=1.0].
","[{'ForeName': 'Yasmine Ali', 'Initials': 'YA', 'LastName': 'Abdelhamid', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; ICU, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia. Electronic address: yasmine.aliabdelhamid@mh.org.au.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; Endocrine and Metabolic Service, Royal Adelaide Hospital, Adelaide, Australia; National Health and Medical Research Council Centre of Research Excellence (CRE) in the Translation of Nutritional Science into Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'White', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; ICU, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Presneill', 'Affiliation': 'ICU, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; Endocrine and Metabolic Service, Royal Adelaide Hospital, Adelaide, Australia; National Health and Medical Research Council Centre of Research Excellence (CRE) in the Translation of Nutritional Science into Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; ICU, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia.'}]",Chest,['10.1016/j.chest.2020.08.011']
2466,32803100,Reduced Bacterial Burden of the Skin Surrounding the Shoulder Joint Following Topical Protocatechuic Acid Application: Results of a Pilot Study.,"Background


Reducing the rising health-care burden associated with shoulder surgical site infection (SSI) is of paramount importance. The purpose of this study was to investigate the antimicrobial efficacy of protocatechuic acid (PCA) as a topical reagent for surgical skin antisepsis surrounding the shoulder joint.
Methods


This was a 2-phase skin-disinfection trial involving the human shoulder. The shoulders of healthy volunteers were randomized to topical treatment with PCA (a 10% concentration of PCA in Phase I [11 subjects] and a 17% concentration in Phase II [12 subjects]), with a control of isopropyl alcohol (IPA) applied to the contralateral shoulder. Mechanical scraping was performed for skin harvest following reagent application, and samples were sent for aerobic and anaerobic culture. Sterilization rates and bacterial counts were determined for each treatment group, and the proportion of subjects with persistent  Cutibacterium acnes  colonization following topical application of PCA was determined using DNA sequencing analysis.
Results


The topical application of 10% PCA was associated with significantly higher aerobic and anaerobic sterilization rates (90.9% and 81.8%, respectively) compared with treatment with IPA (p = 0.0143 and p = 0.0253, respectively). The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  C. acnes  was identified in 18.2% and 0% of subjects following treatment with 10% and 17% PCA, respectively.
Conclusions


The topical application of PCA was associated with a reduction in the bacterial burden of human shoulder skin and demonstrated dose-dependent antimicrobial activity against  C. acnes  in young, healthy subjects. Clinical studies in a shoulder surgical population are warranted to determine the potential for application in surgical skin antisepsis to reduce shoulder SSI.
Level of Evidence


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  ","['young, healthy subjects', 'shoulders of healthy volunteers']","['PCA', 'isopropyl alcohol (IPA', 'protocatechuic acid (PCA']","['aerobic and anaerobic sterilization rates', 'Sterilization rates and bacterial counts', 'anaerobic sterilization rate', 'aerobic sterilization rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0072489', 'cui_str': 'protocatechuic acid'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}]","[{'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",,0.0454613,"The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  ","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Jalali', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, California.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Best', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Schaeffer', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, California.'}]",JB & JS open access,['10.2106/JBJS.OA.19.00078']
2467,32796401,"A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea.","AIM


This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children.
METHODS


A total of 100 infants and children 3-36 months of age with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints.
RESULTS


The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated.
CONCLUSION


S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.",2020,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"['Infants and Children With Acute Diarrhea', '100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children', 'acute diarrhea in children', 'children with acute diarrhea']","['Saccharomyces boulardii', 'Placebo', 'S. boulardii CNCM I-3799 supplementation', 'Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799', 'probiotic group (S. boulardii CNCM I-3799', 'placebo']","['faster normalization of stool consistency', 'time of recovery from diarrhea defined as the duration of diarrhea', 'severity of diarrhea episodes', 'tolerated', 'frequency and consistency of stools', 'time of recovery from diarrhea', 'Faster remission', 'duration and severity of diarrhea']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",100.0,0.251802,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Mourey', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sureja', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Dharmeshkumar', 'Initials': 'D', 'LastName': 'Kheni', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Parthiv', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Hitarth Children Hospital.'}, {'ForeName': 'Devang', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Bakeri Medical Research Centre.'}, {'ForeName': 'Unmesh', 'Initials': 'U', 'LastName': 'Upadhyay', 'Affiliation': 'Iqra Hospital.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Satia', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Dhara', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Troise', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Decherf', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002849']
2468,32805205,"Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND


The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.
METHODS


This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).
FINDINGS


Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION


Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.
FUNDING


Mylan EPD G.K.",2020,"No life-threatening events or treatment-related deaths occurred.
","['288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients', 'healthy volunteers', 'patients with NAFLD without constipation', 'Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT', 'patients with non-alcoholic fatty liver disease', 'patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability', 'Between March 24, 2017, and April 3, 2018', 'patients with NAFLD and constipation', 'Eligible patients']","['computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo', 'U/L', 'Lubiprostone', 'laxative drug lubiprostone', '24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo', 'lubiprostone', 'placebo']","['absolute ALT levels', 'Safety', 'intestinal permeability', 'diarrhoea', 'adverse event', 'efficacy and tolerability', 'efficacy and safety', 'absolute changes in ALT', 'levels of liver enzymes', 'liver stiffness (≤6·7 kPa), and hepatic fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",55.0,0.708799,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Tomeno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kirikoshi', 'Affiliation': 'Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Data Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Oncology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: nakajima-tky@umin.ac.jp.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30216-8']
2469,32805259,Neonatal Abstinence Syndrome Severity Index Predicts 18-Month Neurodevelopmental Outcome in Neonates Randomized to Morphine or Methadone.,"OBJECTIVE


To develop an index to determine which opioid-exposed neonates have the most severe neonatal abstinence syndrome (NAS).
STUDY DESIGN


Full-term neonates with NAS (n = 116) from mothers maintained on methadone or buprenorphine were enrolled from 8 sites into a randomized clinical trial of morphine vs methadone. Ninety-nine (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale (NNNS). At 18 months, 83 of 99 (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), and 77 of 99 (77.7%) were evaluated with the Child Behavior Checklist (CBCL).
RESULTS


Cluster analysis was used to define high (n = 21) and low (n = 77) NAS severity. Compared with infants in the low NAS severity cluster, infants in the high NAS severity cluster had a longer length of stay (P < .001), longer length of stay due to NAS (P < .001), longer duration of treatment due to NAS (P < .001), and higher total dose of the study drug (P < .001) and were more likely to have received phenobarbital (P < .001), to have been treated with morphine (P = .020), and to have an atypical NNNS profile (P = .005). The 2 groups did not differ in terms of maximum Finnegan score. At 18 months, in unadjusted analyses, compared with the high-severity cluster, the low-severity cluster had higher scores on the Bayley-III Cognitive (P = .013), Language (P < .001), and Motor (P = .041) composites and less total behavior problems on the CBCL (P = .028). In adjusted analyses, the difference in the Bayley-III Language composite remained (P = .013).
CONCLUSIONS


Presumptive measures of NAS severity can be aggregated to develop an index that predicts developmental outcomes at age 18 months.",2020,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.",['Full-term neonates with NAS (n=116) from mothers maintained on'],"['morphine vs methadone', 'Morphine or Methadone', 'morphine', 'methadone or buprenorphine']","['longer length of treatment due to NAS', 'Neonatal Abstinence Syndrome Severity Index Predicts', 'maximum Finnegan score', 'Bayley-III Cognitive (P=.013), Language (P<.001) and Motor (P=.041) Composites and less total behavior problems', 'Bayley Scales of Infant and Toddler Development-Third Edition', 'longer length of stay', 'Language Composite', 'hospital discharge using the NICU Network Neurobehavioral Scale (NNNS', 'Child Behavior Checklist (CBCL', 'longer length of stay due to NAS']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.126136,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.","[{'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Flannery', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Camardo', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI; Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: Barry_Lester@Brown.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.034']
2470,32808164,Comparing the trabecular outflow by the response to topical pilocarpine in patients with and without glaucoma filtering surgery.,"PURPOSE


To compare the trabecular outflow by the response to topical pilocarpine administration in patients with and without prior glaucoma filtering surgery.
STUDY DESIGN


Prospective, cross-sectional, randomized, double-blinded study.
METHODS


Open-angle glaucoma (OAG) patients without any prior glaucoma surgery, and those with prior trabeculectomy or tube shunt surgery aged 18-90 years were included. Both groups were randomized into pilocarpine or artificial tears (ATs). Intraocular pressure (IOP) was measured before and 90 min after the instillation of eye drops.
RESULTS


A total of 189 eyes of 189 patients were included: 92 eyes in the pilocarpine and 97 eyes in the ATs group. There was a mean ± standard deviation of - 0.81 ± 3.08 mmHg decrease in IOP with pilocarpine in those without prior surgery, significantly higher than the ATs group (0.55 ± 2.31 mmHg; p = 0.02). No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90). In the surgery group, greater IOP reduction was observed with pilocarpine in those who had undergone surgery within the last three years than those who had surgery three or more years prior (- 1.56 ± 2.64 versus 1.41 ± 2.77 mmHg; p = 0.001).
CONCLUSION


Less IOP reduction was observed with pilocarpine in patients who had filtering surgery more than three years previously compared to those with more recent surgery.",2020,No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90).,"['patients with and without prior glaucoma filtering surgery', 'patients with and without glaucoma filtering surgery', 'A total of 189 eyes of 189 patients were included: 92 eyes in the pilocarpine and 97 eyes in the ATs group', 'Open-angle glaucoma (OAG) patients without any prior glaucoma surgery, and those with prior trabeculectomy or tube shunt surgery aged 18-90\xa0years were included']","['pilocarpine', 'topical pilocarpine', 'pilocarpine or artificial tears (ATs']","['IOP with pilocarpine', 'IOP reduction', 'IOP', 'Intraocular pressure (IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",189.0,0.140909,No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90).,"[{'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Ustaoglu', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA. drmelihustaoglu@gmail.com.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Masoumpour', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sanvicente', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gulati', 'Affiliation': 'Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razeghinejad', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA.'}]",Japanese journal of ophthalmology,['10.1007/s10384-020-00764-x']
2471,32808163,"A Phase 4, Open-Label, Single-Arm Study Assessing the Efficacy and Safety of Ivabradine in African American Patients with Heart Failure and Reduced Ejection Fraction.","INTRODUCTION


There are limited data on ivabradine therapy in black patients and none in African Americans. We performed an open-label, prospective study at two centers in the United States. African American patients with heart failure (HF) (N = 30), left ventricular ejection fraction ≤ 35%, and in sinus rhythm with resting heart rate (HR) ≥ 70 bpm received ivabradine 2.5-7.5 mg twice daily for 57 days.
METHODS


The primary endpoint was change in HR from baseline to day 57, compared with the -5 bpm change observed in the absence of ivabradine in the placebo group of the SHIFT study. The safety endpoint was treatment-emergent adverse events (TEAEs). Exploratory endpoints were change from baseline to day 57 in 6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts.
RESULTS


At day 57, the estimated least squares mean change from baseline in HR was -9.5 bpm (95% CI -13.0, -6.0). The estimated mean treatment difference with ivabradine versus a presumed -5 bpm change from baseline HR, as seen in the placebo group of the SHIFT study, was -4.5 bpm (95% CI -8.0, -1.0; p = 0.013). The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively. Ivabradine therapy did not result in greater physical activity. TEAEs were reported in 11 (36.7%) patients.
CONCLUSION


These data support ivabradine use in African American patients with HF with reduced ejection fraction who meet typical treatment criteria.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03456856.",2020,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","['black patients and none in African Americans', 'African American Patients with Heart Failure and Reduced Ejection Fraction', 'African American patients with heart failure (HF', 'African American patients with HF with reduced ejection fraction who meet typical treatment criteria']","['ivabradine', 'Ivabradine', 'ivabradine 2.5-7.5\xa0mg twice daily for 57\xa0days', 'Ivabradine therapy']","['change in HR', 'greater physical activity', '6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts', 'sinus rhythm with resting heart rate (HR)\u2009≥', 'mean (SE) changes in 6MWT distance and HR difference']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.117285,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA. DLANFEA1@hfhs.org.'}, {'ForeName': 'Kelsey R', 'Initials': 'KR', 'LastName': 'Neaton', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00196-1']
2472,32807539,Medication Education for Dosing Safety: A Randomized Controlled Trial.,"STUDY OBJECTIVE


This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians.
METHODS


We performed a randomized controlled trial in the ED of parents and guardians of children 90 days to 11.9 years of age who were discharged with acetaminophen or ibuprofen, or both. Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing. Participants were called 48 to 72 hours and 5 to 7 days after ED discharge to assess understanding of correct dosing. The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call. Our primary hypothesis was that the intervention would decrease the rate of error from 30% to 10% at 48- to 72-hour follow-up.
RESULTS


We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention. Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm. The difference in proportions was 26% (95% confidence interval [CI] 7% to 46%). There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
CONCLUSIONS


A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours.",2020,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","['by parents or guardians', 'We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention', 'parents and guardians of children 90 days to 11.9 years of age who were discharged with', ' or both']","['acetaminophen or ibuprofen', 'standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing', 'liquid acetaminophen and ibuprofen']","['health literacy and language', 'rate of error', 'reporting safe dosing', 'parent or guardian report of safe dosing at the time of first follow-up call']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",149.0,0.136961,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Naureckas Li', 'Affiliation': ""Division of Pediatric Infectious Diseases, Boston Children's Hospital, Boston, MA. Electronic address: caitlin.li@childrens.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faridi', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Espinola', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Bryan D', 'Initials': 'BD', 'LastName': 'Hayes', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Department of Pharmacy, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Samuels-Kalow', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.007']
2473,32807632,Effects of cognitive behavioral therapy on sleep disturbances and quality of life among adults with type 2 diabetes mellitus: A randomized controlled trial.,"BACKGROUND AND AIMS


Cognitive behavioral therapy (CBT) is recommended as the first-line nonpharmacotherapy for sleep complaints. However, there are no studies that tested CBT for improving sleep quality and increasing quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM). Therefore, this study aims to test the effect of CBT on sleep disturbances and QOL in patients with T2DM.
METHODS AND RESULTS


In total, 187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving CBT with aerobic exercise plus UC, The Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values were collected at baseline, after the 2-month intervention, and 6 months of follow-up. The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up. No difference was found in HbAlc between the two groups (t = -0.47, P = 0.64) after 2-month intervention, while the CBT group had 0.89 units lower HbAlc (95% CI: 0.49-1.28, P < 0.001) than the control group after 6-month follow-up.
CONCLUSION


CBT is effective for sleep disturbances and can also improve sleep quality, increase QOL, and decrease glycemic levels in participants with T2DM.
TRIAL REGISTRATION


Chinese Clinical Trials Registration (Practical study of the appropriate technique for improvement of quality of life of the patients with type 2 diabetes in communities: ChiCTR-IOP-16008045).",2020,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","['187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving', 'adults with type 2 diabetes mellitus', 'participants with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', 'patients with type 2 diabetes in communities']","['Cognitive behavioral therapy (CBT', 'CBT', 'cognitive behavioral therapy', 'CBT with aerobic exercise plus UC']","['glycemic levels', 'quality of life', 'sleep disturbances and QOL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values', 'quality of life (QOL', 'total DSQLS scores', 'sleep disturbances and quality of life', 'sleep quality, increase QOL', 'sleep quality', 'HbAlc']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",187.0,0.0901047,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 2783369510@qq.com.""}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: dzm1001@126.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 11754214@qq.com.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: xzzhangpan@126.com.'}, {'ForeName': 'Guiqiu', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: 1548857561@qq.com.'}, {'ForeName': 'Quanyong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: quanyongxiang@vip.sina.com.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 610492837@qq.com.""}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: 158694402@qq.com.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: yyand4824@hotmail.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: qinyu@jscdc.cn.'}, {'ForeName': 'Peian', 'Initials': 'P', 'LastName': 'Lou', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: lpa82835415@126.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.024']
2474,32807654,Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508).,"INTRODUCTION


Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC.
PATIENTS AND METHODS


Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen.
RESULTS


Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
CONCLUSIONS


This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.",2020,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","['Patients with partial response/stable disease after consolidation therapy', 'Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity', 'Cancer (NS-NSCLC', 'Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA', 'patients with LA-NSCLC', 'Subjects with stage III NS-NSCLC suitable for CRT received', 'Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung', 'patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC']","['Immunotherapy With Tecemotide and Bevacizumab', 'Bevacizumab', 'tecemotide and bevacizumab', 'consolidation immunotherapy', 'chemoradiotherapy (CRT', 'carboplatin/paclitaxel weekly\xa0+ 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel', 'bevacizumab']","['Grade 5 toxicity', 'median progression-free survival', 'safety of this regimen', 'survival', 'median progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.311282,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","[{'ForeName': 'Jyoti D', 'Initials': 'JD', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, IL. Electronic address: jd-patel@northwestern.edu.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Data Science, Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Radiation Oncology, Penn State Cancer Institute, Hersey, PA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Maria Teresa P', 'Initials': 'MTP', 'LastName': 'de Aquino', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Millie S', 'Initials': 'MS', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care, Palo Alto, CA.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Al-Nsour', 'Affiliation': 'Mercy Cancer Centers, Toledo, OH.'}, {'ForeName': 'Christopher S R', 'Initials': 'CSR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Cancer Institute, Fairfax, VA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.007']
2475,32811378,Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.,"BACKGROUND AND PURPOSE


We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke.
METHODS


This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed.
RESULTS


Both DOSE1 (mean change 61 m [95% CI, 9-113],  P =0.02) and DOSE2 (mean change 58 m, 6-110,  P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care.
CONCLUSIONS


This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.",2020,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","['Subjects (n=75; 25/group', '6 Canadian inpatient rehabilitation units, between 2014 and 2018', 'patients with stroke']","['control (usual care) physical therapy', 'DOSE1']","['DOSE2 in gait speed (5-m walk', 'Walking Recovery', 'quality of life (EQ-5D-5 L', 'DOSE2', 'walking endurance at completion of the 4-week intervention (post-evaluation', 'walking endurance benefits', 'walking endurance']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0592141,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","[{'ForeName': 'Tara D', 'Initials': 'TD', 'LastName': 'Klassen', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Bayley', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Toronto, Canada (M.T.B.).'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Benavente', 'Affiliation': 'Division of Neurology (O.B.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Krassioukov', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Pooyania', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Manitoba (S.P.).'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'Department of Physiology & Pharmacology (M.J.P.) University of Calgary, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schneeberg', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janice J', 'Initials': 'JJ', 'LastName': 'Eng', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}]",Stroke,['10.1161/STROKEAHA.120.029245']
2476,32810355,A cluster-randomized study on the Risk Assessment and Management Program for home blood pressure monitoring in an older population with inadequate health literacy.,"The Risk Assessment and Management Program (RAMP) has successfully demonstrated a reduction of blood pressure (BP) and cardiovascular (CVD) risk of patients with hypertension. This study aimed to compare the blood pressure control rate of participants after attended RAMP group, with those attended RAMP individual from usual care. A prospective open cluster-randomized controlled trial was performed in five public primary care clinics. Patients with uncontrolled hypertension were recruited. RAMP group consisted of multi-disciplinary group education on knowledge of hypertension, lifestyle modification, and hands-on home blood pressure monitoring (HBPM) training. Each participant was given a branchial HBPM device. An individual face-to-face nurse follow-up was arranged 6 weeks later. Participants' office BP and clinical parameters were assessed at 6, 12, and 18 months. Three RAMP group and two RAMP-individual clusters recruited 152 and 139 participants, respectively. The mean age was 67.0 (SD 9.9) year. After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P < .001). The systolic BP was reduced by 19.7 mm Hg (95% CI -22.03, -17.40, P < .001) and diastolic BP by 8.1 mm Hg (95% CI -9.66, -6.61, P < .001) in RAMP group while the RAMP individual demonstrated 9.3 mm Hg (95% CI -12.1, -6.4, P < .001) reduction in systolic BP without any significant difference in diastolic BP. The RAMP-group participants' body weight (BW) and body mass index(BMI) had no significant changes, while the RAMP-individual participants had a significant increase in BW and BMI. No adverse effect was reported.",2020,"After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P ","['five public primary care clinics', 'Patients with uncontrolled hypertension', 'older population with inadequate health literacy', 'patients with hypertension', 'participants after attended RAMP group, with those attended RAMP individual from usual care']","['multi-disciplinary group education on knowledge of hypertension, lifestyle modification, and hands-on home blood pressure monitoring (HBPM) training', 'Risk Assessment and Management Program']","['blood pressure (BP) and cardiovascular (CVD) risk', 'diastolic BP', 'BW and BMI', 'BP control rate', 'systolic BP', 'body weight (BW) and body mass index(BMI', 'blood pressure control rate', 'adverse effect']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",5.0,0.0327305,"After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P ","[{'ForeName': 'Sau Nga', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Man Chi', 'Initials': 'MC', 'LastName': 'Dao', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Luk', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Margaret Choi Hing', 'Initials': 'MCH', 'LastName': 'Lam', 'Affiliation': 'Hong Kong Academy of Nursing - HKCCPHN, LG1, School of Nursing, Princess Margaret Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Irene Sau Fan', 'Initials': 'ISF', 'LastName': 'Ho', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Siu Keung', 'Initials': 'SK', 'LastName': 'Cheung', 'Affiliation': 'Department of Sociology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Ap Lei Chau, Hong Kong.'}, {'ForeName': 'Bernard Man Yung', 'Initials': 'BMY', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13987']
2477,32812137,"Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: A Prospective, Randomized Controlled Trial.","BACKGROUND


Soft tissue abscesses are among the most frequently encountered medical problems treated by different surgeons. Standard therapy remains incision and drainage with sterile saline irrigation during postoperative wound healing period. Aim of this prospective randomized controlled trial was to compare sterile irrigation versus nonsterile irrigation.
STUDY DESIGN


A single center randomized controlled trial was performed to investigate postoperative wound irrigation. The control group used sterile irrigation, and the intervention group used nonsterile irrigation. Primary endpoints were reinfection and reintervention rates, assessed during follow-up controls for up to 2 years. Secondary endpoints were the duration of wound healing, inability to work, pain and quality of life.
RESULTS


Between 04/2016 and 05/2017, 118 patients were randomized into two groups, with 61 allocated to the control- and 57 to the intervention group. Reinfection occurred in a total of 4 cases (6.6%) in the sterile protocol and 4 (7%) in the nonsterile protocol. Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams. Despite equal wound persistence rates, a substantially shorter amount of time off from work was reported in the nonsterile protocol group (p value 0.086).
CONCLUSION


This prospective, randomized trial indicates that a nonsterile irrigation protocol for patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol. Moreover, a nonsterile irrigation protocol leads to a shorter period of inability to work with comparable pain and quality of life scores during the wound healing period.",2020,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","['patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol', '118 patients', 'Between 04/2016 and 05/2017', 'Surgically Drained Spontaneous Soft Tissue Abscesses']","['sterile irrigation versus nonsterile irrigation', 'sterile irrigation, and the intervention group used nonsterile irrigation', 'sterile saline irrigation', 'nonsterile irrigation protocol', 'Simple Wound Irrigation']","['Reinfection', 'pain and quality of life scores', 'Quality of life and pain values', 'duration of wound healing, inability to work, pain and quality of life', 'reinfection and reintervention rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound'}]","[{'cui': 'C0205339', 'cui_str': 'Reinfection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4049481', 'cui_str': 'Inability to work'}]",118.0,0.0682539,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany. florianoehme85@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rühle', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, P.O. Box 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Börnert', 'Affiliation': 'Department of Trauma Surgery, Cantonal Hospital Obwalden, Brünigstrasse 181, P.O. Box 6060, 6060, Sarnen, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hempel', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany.'}, {'ForeName': 'B-C', 'Initials': 'BC', 'LastName': 'Link', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Babst', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Metzger', 'Affiliation': 'Department of General Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'F J-P', 'Initials': 'FJ', 'LastName': 'Beeres', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}]",World journal of surgery,['10.1007/s00268-020-05738-1']
2478,32811738,"A single one-minute, comfortable paced, stair-climbing bout reduces postprandial glucose following a mixed meal.","BACKGROUND AND AIMS


Postprandial blood glucose (PBG) is an independent predictor of disease and mortality risk. To date, the shortest, single, moderate-intensity exercise intervention to reduce PBG is a 1 min bout of stair stepping during an oral glucose tolerance test. Whether this effect translates to real meal consumption is unknown.
METHODS AND RESULTS


Subjects (N = 30) participated in a randomized controlled crossover trial performing 0 min (seated control), 1 min, 3 min or 10 min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits. Compared to control, all SCD reduced PBG at least one timepoint: at 30-min the 3 min (-10.8 (-18.7 to -2.8) mg/dL, p = 0.010) and 10 min (-36.3 (-46.4 to -26.3) mg/dL), p < .001), and at 45-min the 1 min (-7.3 (-13.9 to -0.7) mg/dL, p = 0.030, 3 min (-8.7 (-13.9 to -3.6) mg/dL, p = 0.002 and 10 min SCD (-12.2 (-18.2 to -6.1)mg/dL, p < 0.000) reduced PBG. The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005) SCD. All SCD were rated by subjects as very light to light intensity.
CONCLUSIONS


Single, subjectively ""light"" intensity stair climbing and descending bouts as short as 1 min in duration attenuate the postprandial glucose response in normal weight individuals following consumption of a mixed meal. More pronounced effects require longer bouts in a dose-dependent manner.",2020,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)",['Subjects (N\xa0=\xa030'],"['0 min (seated control), 1\xa0min, 3\xa0min or 10\xa0min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits']","['Postprandial blood glucose (PBG', 'SCD', 'SCD reduced PBG', 'PBG', 'postprandial glucose', 'area under the curve (AUC) for PBG', 'incremental AUC (iAUC']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0429009,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA. Electronic address: Jmoore714@gmail.com.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Salmons', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Vinoskey', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.020']
2479,32811740,Self-management education may improve blood pressure in people with type 2 diabetes. A randomized controlled clinical trial.,"BACKGROUND AND AIMS


Diabetes is a suitable model to evaluate intervention programmes aimed at chronic diseases, because of its well-defined and measurable process and outcome indicators. In this study, we aimed at investigating the effects of group based self-management education on clinical and psychological variables in type 2 diabetes.
METHODS AND RESULTS


Four-year randomized controlled clinical trial (ISRCTN14558376) comparing Group Care and traditional one-to-one care. Clinical and psychological variables were monitored at baseline, 2 and 4 years. Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls. Prescription of lipid-lowering and anti-hypertensive agents did not change among the patients on Group Care, whereas anti-hypertensives were stepped up among Controls without improving their blood pressure. Multivariable analysis suggests that blood pressure improvement among patients on Group Care was independent of BMI, duration of diabetes and antihypertensive medication, suggesting a direct effect of education, presumably by increasing adherence. The ""Powerful Others"" dimension of the Locus of Control worsened and fear of complications decreased among Controls.
CONCLUSIONS


The results confirm that a multidisciplinary structured group educational approach improves blood pressure, presumably through better adherence to healthy lifestyle and medication, in people with type 2 diabetes.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN14558376.",2020,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","['type 2 diabetes', 'people with type 2 diabetes']","['lipid-lowering and anti-hypertensive agents', 'Self-management education', 'group based self-management education', 'Group Care and traditional one-to-one care']","['fear of complications', 'blood pressure', 'blood pressure improvement', 'body weight, BMI and HbA1c, systolic and diastolic blood pressure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0581567', 'cui_str': 'One to one care'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.059892,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Trento', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy. Electronic address: marina.trento@unito.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fornengo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Amione', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Salassa', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barutta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Gruden', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Mazzeo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Merlo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chiesa', 'Affiliation': 'Links Foundation, Polytechnic University of Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Charrier', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.023']
2480,32811843,Innovative prolonged-release oral alkalising formulation allowing sustained urine pH increase with twice daily administration: randomised trial in healthy adults.,"A multi-particulate fixed-dose combination product, consisting of a combination of two alkalising salts formulated as prolonged-release granules, ADV7103, was developed to obtain a sustained and prolonged alkalising effect. The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration. The long-lasting coverage of ADV7103 was confirmed through a randomised, placebo-controlled, double-blind, two-period study, measuring its effect on urine pH in healthy adults (n = 16) at doses of alkalising agent ranging between 0.98 and 2.88 meq/kg/day. A significant increase of urine pH with a positive dose-response in healthy adult subjects was shown. Urine pH above 7 was maintained during 24 h with a dosing equivalent to 1.44 meq/kg twice a day, while urine pH was below 6 most of the time with placebo. The effect observed was non-saturating within the range of doses evaluated and the formulation presented a good safety profile. ADV7103 provided an effective prolonged release of alkalising salts to cover a 12-h effect with adequate tolerability and could afford a twice a day (morning and evening) dosing in patients requiring long-term treatment.",2020,"The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration.","['healthy adults (n\u2009=\u200916) at doses of alkalising agent ranging between 0.98\xa0and 2.88\xa0meq/kg/day', 'healthy adult subjects', 'healthy adults']","['ADV7103', 'potassium bicarbonate', 'placebo']","['urine pH', 'Urine pH']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1532570', 'cui_str': 'mEq/kg/day'}]","[{'cui': 'C0071751', 'cui_str': 'potassium bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042044', 'cui_str': 'Urine pH test'}]",,0.373496,"The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Guittet', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel-Maupetit', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Manso-Silván', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guillaumin', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vandenhende', 'Affiliation': 'ClinBay, Genappe, Belgium.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Granier', 'Affiliation': 'Advicenne, Nîmes, France. lagranier@yahoo.fr.'}]",Scientific reports,['10.1038/s41598-020-70549-2']
2481,32812316,Application of WeChat-assisted peri-operative care in children with congenital megacolon.,"AIM


This study explored the clinical effects of WeChat-based peri-operative care on parents of children with congenital megacolon.
METHODS


Participants were randomly divided into WeChat group and telephone group. This study explored parents' knowledge of the care of children with megacolon, the follow-up rate of children, post-operative defaecation function and complications.
RESULTS


WeChat group scored better in nursing knowledge than telephone group, and the difference was statistically significant. The lost follow-up rate in WeChat group was lower than that in telephone group, and the difference was statistically significant. Post-operative defaecation was also better in the WeChat group than in the phone group. Most complications in the phone group were significantly higher than those in the WeChat group.
CONCLUSION


Peri-operative care for parents of children with megacolon through WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.",2020,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","['parents of children with megacolon through', 'Participants', 'parents of children with congenital megacolon', 'children with congenital megacolon']","['WeChat-assisted peri-operative care', 'WeChat-based peri-operative care', 'Peri-operative care', 'WeChat group and telephone']",['nursing knowledge'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025160', 'cui_str': 'Megacolon'}, {'cui': 'C0019569', 'cui_str': ""Hirschsprung's disease""}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0203934,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'YiFan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'DianMing', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'JianXi', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}]",Journal of paediatrics and child health,['10.1111/jpc.14990']
2482,32812025,"Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial.","BACKGROUND


New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19.
METHODS


This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1.
RESULTS


Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray's P = 0.033).
CONCLUSIONS


This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.",2020,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","['adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran', 'hospitalized COVID-19 patients with moderate disease compared with standard care', 'treating patients with COVID-19', 'Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients']","['sofosbuvir plus daclatasvir', 'daclatasvir and 1200\u2009mg ribavirin (intervention group) or to standard care (control group', 'ribavirin']","['median duration of hospital stay', 'recovery and lower death rates', 'number of ICU admissions', 'length of hospital stay', 'number of deaths', 'cumulative incidence of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",48.0,0.112652,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Shabani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Babamahmoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Davoudi Badabi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alikhani', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Cancer Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Hemoglobinopathy Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Accident and Emergency Department, Homerton University Hospital NHS Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Tirgar Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa332']
2483,32812039,Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.,"BACKGROUND


Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19.
METHODS


This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2.
RESULTS


Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported.
CONCLUSIONS


The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.",2020,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"['adults with moderate or severe COVID-19 admitted to four university hospitals in Iran', 'patients admitted to hospital with moderate or severe coronavirus infection (COVID-19', '66 patients', 'Between 26 March and 26 April 2020', 'patients with moderate or severe COVID-19']","['sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone', 'Sofosbuvir and daclatasvir']","['median duration of hospitalization', 'duration of hospital stay', 'Clinical recovery', 'serious adverse events', 'deaths', 'clinical recovery', 'Cumulative incidence of hospital discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",66.0,0.111872,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali Asgari', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran.'}, {'ForeName': 'Zahedin', 'Initials': 'Z', 'LastName': 'Kheiri', 'Affiliation': 'Department of Internal Medicine, Baharloo hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushirvani', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of infectious diseases, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Hosamirudsai', 'Affiliation': 'Department of Infectious Diseases, Baharloo Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Afhami', 'Affiliation': 'Department of infectious diseases, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akbarpour', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'Department of Pulmonary and Critical Care, Shariati Hospital, Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Radmard', 'Affiliation': 'Department of Radiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Davarpanah', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Emergency Medicine, Homerton University Hospital, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa334']
2484,32812177,Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.,"BACKGROUND


Breast lymphoedema can occur following surgical treatment for breast cancer. We investigated whether an exercise program reduced breast lymphoedema symptoms compared to a non-exercise control group.
METHODS


A single-blinded randomised controlled trial was conducted in which women with stable breast lymphoedema (n = 89) were randomised into an exercise (n = 41) or control (n = 47) group. The intervention comprised a 12-week combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist. All participants completed a weekly symptoms diary and were assessed monthly to ensure that there was no exacerbation of their lymphoedema. Changes in the breast were captured physically with ultrasound and bioimpedance spectroscopy and changes in symptoms were captured using European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires.
RESULTS


The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions. Measures of extracellular fluid, assessed with bioimpedance spectroscopy ratio, decreased in the exercise group compared to the control group. No significant difference was detected in dermal thickness in the breast, assessed by ultrasound. Session attendance in the exercise sessions was high, with two musculoskeletal adverse events reported, but no exacerbations of lymphoedema observed.
CONCLUSION


Combined resistance and aerobic exercise training is safe for women living with breast lymphoedema. Preliminary data suggest exercise training can reduce breast lymphoedema symptoms to a greater extent than usual care.",2020,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","['breast cancer', 'breast lymphoedema secondary to breast cancer', 'women living with breast lymphoedema', 'women with stable breast lymphoedema (n\u2009=\u200989']","['exercise training', 'Combined resistance and aerobic exercise training', 'exercise program', 'combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist', 'exercise (n\u2009=\u200941) or control']","['breast lymphoedema symptoms', 'Session attendance', 'dermal thickness', 'bioimpedance spectroscopy ratio', 'Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires', 'breast-related symptoms', 'Cancer (EORTC']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",89.0,0.0640697,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Kilbreath', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia. sharon.kilbreath@sydney.edu.au.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Degnim', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hackett', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05863-4']
2485,32814582,Gut microbiota modulation with long-chain corn bran arabinoxylan in adults with overweight and obesity is linked to an individualized temporal increase in fecal propionate.,"BACKGROUND


Variability in the health effects of dietary fiber might arise from inter-individual differences in the gut microbiota's ability to ferment these substrates into beneficial metabolites. Our understanding of what drives this individuality is vastly incomplete and will require an ecological perspective as microbiomes function as complex inter-connected communities. Here, we performed a parallel two-arm, exploratory randomized controlled trial in 31 adults with overweight and class-I obesity to characterize the effects of long-chain, complex arabinoxylan (n = 15) at high supplementation doses (female: 25 g/day; male: 35 g/day) on gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose (n = 16, non-fermentable control), and integrated the findings using an ecological framework.
RESULTS


Arabinoxylan resulted in a global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri. Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants. The two groups showed differences in compositional shifts of the microbiota (p ≤ 0.025, PERMANOVA), and multiple linear regression (MLR) analyses revealed that the propionate response was predictable through shifts and, to a lesser degree, baseline composition of the microbiota. Principal components (PCs) derived from community data were better predictors in MLR models as compared to single taxa, indicating that arabinoxylan fermentation is the result of multi-species interactions within microbiomes.
CONCLUSION


This study showed that long-chain arabinoxylan modulates both microbiota composition and the output of health-relevant SCFAs, providing information for a more targeted application of this fiber. Variation in propionate production was linked to both compositional shifts and baseline composition, with PCs derived from shifts of the global microbial community showing the strongest associations. These findings constitute a proof-of-concept for the merit of an ecological framework that considers features of the wider gut microbial community for the prediction of metabolic outcomes of dietary fiber fermentation. This provides a basis to personalize the use of dietary fiber in nutritional application and to stratify human populations by relevant gut microbiota features to account for the inconsistent health effects in human intervention studies.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02322112 , registered on July 3, 2015. Video Abstract.",2020,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","['adults with overweight and obesity', '31 adults with overweight and class']","['long-chain, complex arabinoxylan', 'gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose', 'long-chain corn bran arabinoxylan']","['global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri', 'compositional shifts of the microbiota', 'fecal propionate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0353942', 'cui_str': 'Bran'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0318080', 'cui_str': 'Ruminococcus obeum'}, {'cui': 'C1195810', 'cui_str': 'Prevotella copri'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0033474', 'cui_str': 'Propanoates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",31.0,0.039378,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","[{'ForeName': 'Nguyen K', 'Initials': 'NK', 'LastName': 'Nguyen', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Deehan', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Zhengxiao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Baskota', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Perez-Muñoz', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Yunus E', 'Initials': 'YE', 'LastName': 'Tuncil', 'Affiliation': 'Food Engineering Department, Ordu University, 52200, Ordu, Turkey.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Seethaler', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes and Centre Européen Nutrition Santé, 69310, Pierre Bénite, France.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephan C', 'Initials': 'SC', 'LastName': 'Bischoff', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Hamaker', 'Affiliation': 'Whistler Center for Carbohydrate Research and Department of Food Science, Purdue University, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Martínez', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bakal', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada. jenswalter@ucc.ie.'}]",Microbiome,['10.1186/s40168-020-00887-w']
2486,32814825,"Functional, physiological and subjective responses to concurrent neuromuscular electrical stimulation (NMES) exercise in adult cancer survivors: a controlled prospective study.","The primary aim of this study was to investigate the functional, physiological and subjective responses to NMES exercise in cancer patients. Participants with a cancer diagnosis, currently undergoing treatment, and an had an Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) of 1 and 2 were recommended to participate by their oncologist. Following a 2-week, no-NMES control period, each participant was asked to undertake a concurrent NMES exercise intervention over a 4-week period. Functional muscle strength [30 s sit-to-stand (30STS)], mobility [timed up and go (TUG)], exercise capacity [6-min walk test (6MWT)] and health related quality of life (HR-QoL) were assessed at baseline 1 (BL1), 2-week post control (BL2) and post 4-week NMES exercise intervention (POST). Physiological and subjective responses to LF-NMES were assessed during a 10-stage incremental session, recorded at BL2 and POST. Fourteen participants [mean age: 62 years (10)] completed the intervention. No adverse events were reported. 30STS (+ 2.4 reps, p = .007), and 6MWT (+ 44.3 m, p = .028) significantly improved after the intervention. No changes in TUG or HR-QoL were observed at POST. Concurrent NMES exercise may be an effective exercise intervention for augmenting physical function in participants with cancer and moderate and poor functional status. Implications for cancer survivors: By allowing participants to achieve therapeutic levels of exercise, concurrent NMES may be an effective supportive intervention in cancer rehabilitation.",2020,No adverse events were reported.,"['participants with cancer and moderate and poor functional status', 'Fourteen participants [mean age: 62\xa0years (10', 'cancer patients', 'Participants with a cancer diagnosis, currently undergoing treatment, and an had an Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) of 1 and 2 were recommended to participate by their oncologist', 'adult cancer survivors', 'cancer survivors']","['NMES exercise', 'concurrent neuromuscular electrical stimulation (NMES) exercise', 'NMES exercise intervention', 'Functional muscle strength [30\xa0s sit-to-stand (30STS', 'Concurrent NMES exercise']","['adverse events', ' mobility [timed up and go (TUG)], exercise capacity [6-min walk test (6MWT)] and health related quality of life (HR-QoL', 'TUG or HR-QoL']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0568257,No adverse events were reported.,"[{'ForeName': 'Dominic', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland. dominic.oconnor@insight-centre.org.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Lennon', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Matilde Mora', 'Initials': 'MM', 'LastName': 'Fernandez', 'Affiliation': 'Clinica Oncoavanze, Seville, Spain.'}, {'ForeName': 'Gabriel Ruiz', 'Initials': 'GR', 'LastName': 'Signorelli', 'Affiliation': ""The Insight Centre for Data Analytics, O'Brien Centre for Science, University College Dublin, Belfield Campus, Dublin, Ireland.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Caulfield', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",Scientific reports,['10.1038/s41598-020-71006-w']
2487,32815991,Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.,"Importance


The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
Objective


To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
Design, Setting, and Participants


The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.
Interventions


Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
Main Outcomes and Measures


The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
Results


A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.
Conclusions and Relevance


The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.
Trial Registration


ClinicalTrials.gov Identifier: NCT03007550.",2020,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","['214 patients', '105 patients in the LTG group and 109 patients in the OTG group', 'From January 2017 to September 2018, a total of 227 patients were enrolled', 'I Gastric Cancer', 'patients with clinical stage I gastric cancer']","['CLASS02', 'laparoscopic total gastrectomy (LTG', 'LTG', 'Laparoscopic vs Open Total Gastrectomy', 'LTG vs OTG with lymphadenectomy', 'conventional open total gastrectomy (OTG', 'OTG']","['overall morbidity and mortality rates', 'recovery courses and postoperative hospital stays', 'Intraoperative complications', 'mortality', 'distribution of complication severity', 'overall postoperative complication rate', 'morbidity and mortality', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}]","[{'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",227.0,0.250567,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","[{'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of General Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Naiqing', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.3152']
2488,32815436,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.,"Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA 1   c ) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that the addition of oral semaglutide reduces HbA 1   c  and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.",2020,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.",['patients with type 2 diabetes'],"['Oral semaglutide', 'oral semaglutide monotherapy', 'empagliflozin', 'oral antihyperglycemic agents and placebo', 'placebo, empagliflozin 25 mg, or sitagliptin 100 mg', 'oral semaglutide', 'placebo']","['HbA 1c  and body weight', 'Body weight reductions', 'glycated hemoglobin (HbA 1c ', 'Severe or blood glucose-confirmed symptomatic hypoglycemia', 'body weight reductions', 'nausea', 'Gastrointestinal adverse events (AEs) with oral semaglutide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",,0.127093,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lavernia', 'Affiliation': 'North Broward Diabetes Center , Pompano Beach, FL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1798638']
2489,32815439,"Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients.","Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.",2020,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"['older patients and/or those with comorbidities', 'patients with comorbidities', 'patients at high cardiovascular risk', 'Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years', 'patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients', 'patients with moderate renal impairment']","['Oral semaglutide', 'ETD', 'placebo']","['renal function', 'body weight', 'glycated hemoglobin', 'cardiovascular safety of oral semaglutide', 'safety profile of oral semaglutide', 'glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}]",,0.0838752,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem , Jerusalem, Israel.'}, {'ForeName': 'Eden M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation , Bend, OR, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East , Greenville, NC, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1800286']
2490,32815423,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.,"Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA 1   c ) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1   c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.",2020,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","['people with type 2 diabetes (T2D) who require treatment intensification', 'patients with T2D already on insulin therapy', 'patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy', 'patients uncontrolled on oral glucose-lowering therapies']","['liraglutide', 'oral semaglutide', 'oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo', 'glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin', 'placebo']","['HbA 1c  and body weight', 'body weight with oral semaglutide', 'total daily insulin dosage', 'body weight loss', 'low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia', 'glycated hemoglobin (HbA 1c ', 'tolerability profile of oral semaglutide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0294087,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","[{'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Wright', 'Affiliation': 'Charlotte Area Health Education Center , Charlotte, NC, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital; Harvard Medical School , Boston, MA, USA.""}]",Postgraduate medicine,['10.1080/00325481.2020.1798127']
2491,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
2492,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2021,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
2493,32815648,A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial.,"Digital therapeutics is a new approach to treat hypertension via using software programs such as smartphone apps and/or device algorithms. We develop a HERB system-new interactive smartphone app (HERB Mobile) with web-based patient management console (HERB Console)-to lower blood pressure (BP) based on an algorithm that helps users to promote lifestyle modifications in conjunction with medically validated non-pharmacological interventions. The app can assess the personalities, behavior characteristics, and hypertension determinants of each patient with hypertension to provide adequate guidance. To demonstrate the efficacy of the system, we designed a randomized, controlled, multicenter, open-label trial ""HERB-DH1 (HERB digital hypertension 1)"" to assess the efficacy of HERB system in patients with essential hypertension. The authors allocate patients to the intervention group (HERB system + standard lifestyle modification) or to the control group (standard lifestyle modification alone). In the intervention group, we provide the HERB Mobile for patients and the HERB Console for their primary physicians for 24 weeks. Both groups are instructed for standard lifestyle modifications based on the current recommendations in the Japanese Society of Hypertension 2019 guideline. The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring. We started this study in December of 2019, and the trial results will be expected in early 2021. We believe that this trial enables us to verify the efficacy of the HERB system in patients with essential hypertension.",2020,The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring.,['patients with essential hypertension'],"['intervention group (HERB system\xa0+\xa0standard lifestyle modification) or to the control group (standard lifestyle modification alone', 'HERB system-new interactive smartphone app (HERB Mobile) with web-based patient management console (HERB Console)-to lower blood pressure (BP', 'HERB Mobile']",['mean change from baseline to 12\xa0weeks in 24-hour systolic BP measured by ambulatory BP monitoring'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3873699', 'cui_str': 'Console'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]",,0.0486544,The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring.,"[{'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nomura', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Tanigawa', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Kiyose', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Okura', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Hida', 'Affiliation': 'Department of Biostatistics and Data Science, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kohta', 'Initials': 'K', 'LastName': 'Satake', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13993']
2494,32814610,Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist.,"OBJECTIVE


Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.
DESIGN


Cluster randomized controlled trial.
SETTING


Six medicine teams at an academic medical facility.
PATIENTS


Inpatients who received antibiotics and were cared for by a medicine team.
INTERVENTION


In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).
RESULTS


In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
CONCLUSIONS


Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.",2020,"We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
","['Six medicine teams at an academic medical facility', 'Inpatients who received antibiotics and were cared for by a medicine team']","['levofloxacin', 'antibiotic time-out led by a team-based pharmacist']","['ratio of oral (PO) to intravenous (IV) DOT', 'mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events', 'ATO initiation', 'Overall antibiotic use']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",290.0,0.0513372,"We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
","[{'ForeName': 'Trevor C', 'Initials': 'TC', 'LastName': 'Van Schooneveld', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Rupp', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'R Jenifer', 'Initials': 'RJ', 'LastName': 'Cavaleiri', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lyden', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Kiri', 'Initials': 'K', 'LastName': 'Rolek', 'Affiliation': 'College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.347']
2495,32816002,Associations of Variation in Retinal Thickness With Visual Acuity and Anatomic Outcomes in Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With Anti-Vascular Endothelial Growth Factor Agents.,"Importance


When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
Objective


To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
Design, Setting, and Participants


In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Main Outcomes and Measures


Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Results


Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Conclusions and Relevance


Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.",2020,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","['1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years', 'Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020', 'eyes with nAMD initiating anti-VEGF treatment', 'Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included', 'patients with neovascular age-related macular degeneration (nAMD', 'Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With']","['anti-vascular endothelial growth factor (VEGF) treatment', 'Anti-Vascular Endothelial Growth Factor Agents']","['Measures\n\n\nFoveal center point thicknesses (FCPTs', 'risk of developing fibrosis and macular atrophy', 'median (interquartile range) FCPT SD']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.209385,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3001']
2496,32819681,Five-Year Outcomes and Prognostic Value of Feature-Tracking Cardiovascular Magnetic Resonance in Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction.,"The aim of the present study was to investigate the long-term impact of early intravenous metoprolol in ST-segment elevation myocardial infarction (STEMI) patients in terms of left ventricular (LV) strain with feature-tracking cardiovascular magnetic resonance (CMR) and its association with prognosis. A total of 270 patients with first anterior STEMI enrolled in the randomized METOCARD-CNIC clinical trial, assigned to receive up to 15 mg intravenous metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy, were included. LV global circumferential (GCS) and longitudinal (GLS) strain were assessed with feature-tracking CMR at 1 week after STEMI in 215 patients. The occurrence of major adverse cardiac events (MACE) at 5-year follow-up was the primary end point. Among 270 patients enrolled, 17 of 139 patients assigned to metoprolol arm and 31 of 131 patients assigned to control arm experienced MACE (hazard ratio [HR] 0.500, 95% confidence interval [CI] 0.277 to 0.903; p = 0.022). Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001). On multivariable analysis, LV GLS provided incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE + LVEF chi-square = 12.865, LGE + LVEF + GLS chi-square = 18.459; p =0.012). Patients with GLS ≥-11.5% (above median value) who received early intravenous metoprolol were 64% less likely to experience MACE than their counterparts with same degree of GLS impairment (HR 0.356, 95% CI 0.129 to 0.979; p = 0.045). In conclusion, early intravenous metoprolol has a long-term beneficial prognostic effect, particularly in patients with severely impaired LV systolic function. LV GLS with feature-tracking CMR early after percutaneous coronary intervention offers incremental prognostic value over conventional CMR parameters in risk stratification of STEMI patients.",2020,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","['215 patients', 'STEMI patients', 'Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction', '270 patients enrolled, 17 of 139 patients assigned to', 'patients with severely impaired LV systolic function', '270 patients with first anterior STEMI enrolled']","['metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy', 'metoprolol']","['incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE\u202f+\u202fLVEF chi-square', 'GLS impairment', 'occurrence of major adverse cardiac events (MACE', 'LV global circumferential (GCS) and longitudinal (GLS) strain', 'Impaired LV GCS and GLS strain']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",270.0,0.0522323,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands; University Medical Centre Maribor, Maribor, Slovenia; Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Ruber Juan Bravo Hospital Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ajmone Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: v.delgado@lumc.nl.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.07.037']
2497,32820647,"Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network's Marfan Trial experience.","BACKGROUND/AIMS


The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.
METHODS


Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.
RESULTS


Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
CONCLUSION


Overall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.",2020,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","['young adults and African Americans', 'Young adult and African American participants', 'eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise', '608 children and young adults with Marfan syndrome']","['losartan', 'atenolol']","['Medication adherence', 'Recruitment, retention, and adherence questionnaires', 'Retention', 'mean percentage of medication taken', 'Completion rates for visits, Holter monitors, and quarterly calls', 'completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls', 'Recruitment, retention, and adherence', 'Protocol adherence', 'Overall adherence', 'lower levels of adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013799', 'cui_str': 'Ambulatory ECG'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",608.0,0.169075,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Grima', 'Affiliation': 'The Marfan Foundation, Port Washington, NY, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.""}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'MacNeal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Sylvester', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520945988']
2498,32816561,Stent evaluation by coronary computed tomography angiography: a comparison between Iopamidol-370 and Ioversol-320 hypo-osmolar iodine concentration contrasts.,"OBJECTIVE


Qualitative and quantitative image analysis between Iopamidol-370 and Ioversol-320 in stents´ evaluation by coronary computed tomography angiography (CTA).
METHODS


Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to Iopamidol I-370 ( n  = 33) or Ioversol I-320 ( n  = 32) in this prospective, double-blind, non-inferiority, randomized trial. Stent lumen image quality was graded by 5-point Likert Scale. Lumen mean attenuation was measured at native coronary segments: pre-stent, post-stent, distal segments and at coronary plaques. Lumen attenuation increase (LAI) ratio was calculated for all stents. Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening were also assessed.
RESULTS


Image quality was similar between groups, with no significant difference (Likert score 4.48 ± 0.75  vs  4.54 ± 0.65,  p  = 0.5). There were similarities in LAI ratio between I-370 and I-320 (0.39 ± 0.42  vs  0.48 ± 0.44 HU,  p  = 0.08). Regarding lumen mean attenuation at native coronary segments, a significant difference was observed, with I-320 presenting lower values, including contrast mean attenuation in distal segments. After statistical multivariate analysis, three variables correlated with stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio.
CONCLUSIONS


There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio. Advances in knowledge: Coronary CTA allows adequate stents' visualization and image quality is influenced by stent diameter, HR variation and LAI ratio.Stents' image quality showed no difference between different concentration contrasts (I-370 vs. I-320); however, higher concentration contrasts may provide an improved overall visualization, especially regarding coronary distal segments.",2020,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","['knowledge', 'Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to']","['coronary computed tomography angiography', 'coronary computed tomography angiography (CTA', 'Iopamidol I-370 ( n  = 33) or Ioversol I-320']","['Lumen mean attenuation', 'Stent lumen image quality', 'stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio', 'Image quality', 'Lumen attenuation increase (LAI) ratio', 'Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening', 'LAI ratio']","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0022026', 'cui_str': 'Iopamidol'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0234193', 'cui_str': 'Ability to sense heat'}]",65.0,0.112651,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","[{'ForeName': 'Annelisa Moura', 'Initials': 'AM', 'LastName': 'Garcia', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Antonildes N', 'Initials': 'AN', 'LastName': 'Assunção-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Roberto Nery', 'Initials': 'RN', 'LastName': 'Dantas-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jose Rodrigues', 'Initials': 'JR', 'LastName': 'Parga', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ganem', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}]",The British journal of radiology,['10.1259/bjr.20200078']
2499,32821939,Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown.
Objective


To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment.
Design, Setting, and Participants


Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020.
Interventions


Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d.
Main Outcomes and Measures


The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group.
Results


Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.
Conclusions and Relevance


Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.
Trial Registration


ClinicalTrials.gov Identifier: NCT04292730.",2020,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"['patients with moderate COVID-19', '94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia', '596 patients who were randomized', 'Patients With Moderate COVID-19', 'hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation', 'patients with severe coronavirus disease 2019 (COVID-19', ' 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial']","['Remdesivir vs Standard Care', 'remdesivir treatment', 'placebo']","['headache', 'Nausea', 'clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7', 'hypokalemia', 'clinical status distribution', 'Median length of treatment', 'clinical status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.105766,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"[{'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Arribas López', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cattelan', 'Affiliation': 'Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Soriano Viladomiu', 'Affiliation': 'Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Onyema', 'Initials': 'O', 'LastName': 'Ogbuagu', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Louis Yi Ann', 'Initials': 'LYA', 'LastName': 'Chai', 'Affiliation': 'National University Health System, Singapore.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Owen Tak Yin', 'Initials': 'OTY', 'LastName': 'Tsang', 'Affiliation': 'Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Le Turnier', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'McPhail', 'Affiliation': ""King's College, London, England.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhagani', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': 'Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16349']
2500,32821954,[Randomized controlled trial for palliative radiotherapy of head and neck cancer-challenges remain].,,2020,,[],['palliative radiotherapy'],[],[],"[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.116873,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fabian', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland. alexander.fabian@uksh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Dunst', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01672-2']
2501,32816741,Primary care doctors' views on self-monitoring of blood pressure and self-titration among patients with uncontrolled hypertension in Spain. The ADAMPA trial focus group study.,"BACKGROUND


Despite the increased use of blood pressure (BP) monitoring devices at home, the hypertension of more than 50% of European patients remains uncontrolled. Nevertheless, the self-management of BP, through the combination of home monitoring of BP with self-titration, could be anaccessible and effective tool for improving hypertension control in the primary care setting. The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
AIM


To explore the views and attitudes of primary care doctors participating in the ADAMPA trial regarding BPSM with self-titration.
DESIGN & SETTING


A focus group study took place with primary care doctors participating in the ADAMPA trial, which was carried out in one health district of the Valencia Health System in Spain.
METHOD


Nine primary care doctors participating in the ADAMPA trial were included in the focus group. Three researchers (two using manual methods and one using NVivo software) independently conducted a content analysis, reading the transcripts, identifying, classifying, and coding the contents, and developing a conceptual scheme based on these topics.
RESULTS


Participating doctors clearly support home BP monitoring (HBPM), the setting of individual BP targets, and incorporating patient readings into decision-making. They consider it an investment to educate patients for medication self-adjustment and estimate that an important proportion of their patients are potential candidates for hypertension self-management with medication self-titration. However, they show important divergences regarding the role of nursing in BP control.
CONCLUSION


Primary care doctors participating in the ADAMPA trial feel comfortable with BPSM with self-titration, and would consider extending its use (or the use of some components, such as BP target setting) to other patients with hypertension outside the trial.",2020,"The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
","['Nine primary care doctors participating in the ADAMPA trial were included in the focus group', 'patients with uncontrolled hypertension in Spain', 'primary care doctors participating in the ADAMPA trial regarding BPSM with self-titration', 'patients with poorly controlled hypertension', 'A focus group study took place with primary care doctors participating in the ADAMPA trial, which was carried out in one health district of the Valencia Health System in Spain']",['BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care'],"['blood pressure (BP) monitoring devices', 'home BP monitoring (HBPM']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]",,0.0296267,"The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Marco-Moreno', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martínez-Ibañez', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Avelino-Hidalgo', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bellot-Pujalte', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Barreira-Franch', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Martínez-Ibañez', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Escrig-Veses', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giménez-Loreiro', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Bóveda-García', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Calleja-Del-Ser', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hurtado', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Aníbal', 'Initials': 'A', 'LastName': 'García-Sempere', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Rodríguez-Bernal', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Peiró', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sanfélix-Genovés', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sanfelix-Gimeno', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain sanfelix_gab@gva.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJGP open,['10.3399/bjgpopen20X101062']
2502,32825337,Enhancing Cognitive Performance of Healthy Czech Seniors through Non-Native Language Learning-A Mixed-Methods Pilot Study.,"The aim of this article is to discuss the effect of learning a non-native language on the enhancement of cognitive performance in healthy native Czech elderly. In addition, special emphasis is put on the qualitative assessment. To do this, 42 Czech cognitively unimpaired seniors were enrolled into the study. These were then divided into an experimental group (i.e., 20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention). The main outcome measures included the Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis. The results indicate that the cognitive performance of the intervention group did not differ from the control group. Therefore, no cognitive enhancement through non-native language learning was achieved. However, the findings of the qualitative analysis show that such non-native language learning with the peers of the same age is especially beneficial for the overall well-being of healthy seniors, especially as far as their social networks are concerned. Furthermore, participant's subjective feelings from their self-reports indicate that foreign language learning also contributes to acquiring new English words and phrases. However, as there are very few empirical studies on this research topic, further research is needed in order to confirm or refute the present research findings on the enhancement of cognitive performance through non-native language learning in healthy seniors.",2020,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"['42 Czech cognitively unimpaired seniors were enrolled into the study', '20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention', 'Healthy Czech Seniors', 'healthy native Czech elderly', 'healthy seniors']",['learning a non-native language'],"['cognitive performance', 'Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis']","[{'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",20.0,0.0153599,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"[{'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Klimova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Slaninova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Prazak', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Kacetl', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Valis', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}]",Brain sciences,['10.3390/brainsci10090573']
2503,32826543,The Impact of Receiving a Family-Oriented Therapeutic Conversation Intervention Before and During Bereavement Among Family Cancer Caregivers: A Nonrandomized Trial.,"Effective communication is the foundation of quality care in palliative nursing. As frontline palliative home care providers, nurses could foster more effective bereavement coping skills through therapeutic conversations. The purpose of this study was to evaluate the impact of a nursing intervention offered to bereaved family cancer caregivers. This was a quasi-experimental design, with a posttest-only comparison of the intervention and control groups receiving usual care. Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed measures of depression, anxiety, stress, and grief reactions 3, 5, and 6 months after their close relative had died.There was a significant decrease in anxiety symptoms in the intervention group compared with the control group across all 3 time points. Anxiety and stress symptoms also decreased over time in the 2 groups combined, but this decrease was not observed for depression. When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.Results demonstrate that providing bereaved family caregivers the opportunity to participate in a therapeutic conversation intervention might reduce distressing symptoms in early bereavement.",2020,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","['Family Cancer Caregivers', 'bereaved family cancer caregivers', 'Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed', 'palliative nursing']","['Receiving a Family-Oriented Therapeutic Conversation Intervention', 'control groups receiving usual care', 'nursing intervention']","['controlled grief responses', 'anxiety symptoms', 'Anxiety and stress symptoms', 'distressing symptoms', 'measures of depression, anxiety, stress, and grief reactions']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3816218', 'cui_str': 'Palliative Care Nursing'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",51.0,0.0187652,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","[{'ForeName': 'Asta B', 'Initials': 'AB', 'LastName': 'Petursdottir', 'Affiliation': 'Asta B. Petursdottir, PhD, RN, School of Health Sciences, University of Iceland; Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and Faculty of Nursing, School of Health Sciences, Faculty of Nursing at the University of Iceland. Valgerdur Sigurdardottir, MD, PhD, Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and clinical lector, School of Health Sciences, University of Iceland, Iceland. Mary Kay Rayens, PhD, University of Kentucky, Lexington. Erla Kolbrun Svavarsdottir, PhD, RN, FAAN, is professor at the School of Health Sciences, Faculty of Nursing at the University of Iceland and the Head of Research and Development in Family Nursing at Landspitali the National University Hospital in Reykjavik, Iceland.'}, {'ForeName': 'Valgerdur', 'Initials': 'V', 'LastName': 'Sigurdardottir', 'Affiliation': ''}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': ''}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000679']
2504,32825588,TILs Immunophenotype in Breast Cancer Predicts Local Failure and Overall Survival: Analysis in a Large Radiotherapy Trial with Long-Term Follow-Up.,"AIM


To determine the prognostic significance of the immunophenotype of tumour-infiltrating lymphocytes (TILs) within a cohort of breast cancer patients with long-term follow-up.
METHODS


Multiplexed immunofluorescence and automated image analysis were used to assess the expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1 in a clinical trial of local excision and radiotherapy randomised to a cavity boost or not ( n  = 485, median follow-up 16 years). Kaplan-Meier and Cox multivariate analysis (MVA) methodology were used to ascertain relationships with local recurrence (LR), overall survival (OS) and disease-free survival (DFS). NanoString BC360 gene expression panel was applied to a subset of luminal patients to identify pathways associated with LR.
RESULTS


LR was predicted by low CD8 in MVA in the whole cohort (HR 2.34, CI 1.4-4.02,  p  = 0.002) and luminal tumours (HR 2.19, CI 1.23-3.92,  p  = 0.008) with associations with increased stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2. Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
CONCLUSIONS


Immunophenotype adds further prognostic data to help further stratify risk of LR and OS even in TILs low-luminal tumours.",2020,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
",['breast cancer patients with long-term'],"['Immunophenotype', 'local excision and radiotherapy']","['local recurrence (LR), overall survival (OS) and disease-free survival (DFS', 'luminal tumours', 'Poor OS', 'low CD8 in MVA', 'expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1', 'stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0079611', 'cui_str': 'Immunophenotyping'}, {'cui': 'C0278259', 'cui_str': 'Local excision'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0016632', 'cui_str': 'Fox-Fordyce disease'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1568630', 'cui_str': 'SOX2 protein, human'}]",,0.133403,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
","[{'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Millar', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Browne', 'Affiliation': 'Cancer Care Centre, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Slapetova', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shang', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bradshaw', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ann Brauer', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown, NSW 2217, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Beretov', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Whan', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Graham', 'Affiliation': 'Faculty of Medicine, St George & Sutherland Clinical School, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}]",Cancers,['10.3390/cancers12092365']
2505,32822653,The plasma levels of atrial natriuretic peptide and brain natriuretic peptide in type 2 diabetes treated with sodium-glucose cotransporter-2 inhibitor.,"PURPOSE


The aim of this study was to determine the levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) after treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor or dipeptidyl peptidase-4 (DPP4) inhibitor in patients with type-2 diabetes inadequately controlled by insulin, and to determine whether variation in ANP levels can explain favorable cardiovascular outcome.
METHODS


We enrolled 56 patients, aged 18-80years, with type-2 diabetes inadequately controlled by insulin: i.e., HbA1c level 7.5-10.5% despite at least 8weeks' injectable insulin at a stable mean dose of 20-150IU daily, with or without no more than two oral antidiabetic agents.
FINDINGS


The 56 patients were randomized between 3 treatment groups: SGLT2 inhibitor (n=18), DPP4 inhibitor (n=19) and placebo (n=19). Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all showed significantly lower HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24weeks than controls. SGLT2 inhibitor treatment decreased ANP levels, BNP levels, systolic blood pressure and weight compared with placebo. Compared to those receiving DPP4 inhibitor, patients receiving SGLT2 inhibitor showed lower HbA1c levels (7.01 vs. 7.58%; P=0.03), ANP levels (28.41 vs. 43.03 pg/mL; P=0.00) and weight (66.14 vs. 71.76 kg; P=0.04) at 24weeks after adjusting for baseline values. The SGLT2 inhibitor group showed higher sodium concentrations than the placebo and DPP4 inhibitor groups (145.89 vs. 143.89 and 144.79 mmol/L, respectively; P=0.00 and P=0.04) at 24 weeks. ANP and BNP levels did not significantly correlate with HbA1c and blood glucose levels.
IMPLICATIONS


These results indicated that SGLT2 inhibitors may be superior to DPP4 inhibitors in reducing risk of cardiovascular disease in diabetic patients. The major study limitation was the small number of patients per group, which should be enlarged in further research.",2020,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","['patients with diabetes', '56 patients with type 2 diabetes mellitus that was inadequately controlled with insulin; the subjects were all 18∼80 years of age', 'A total of 56 patients', 'patients with type 2 diabetes mellitus', 'patients who still experienced inadequate glycaemic control (HbA1c levels of 7.5∼10.5 %) were recruited']","['DPP4 inhibitor', 'placebo', 'SGLT2 inhibitor', 'SGLT2', 'sodium-glucose cotransporter-2 inhibitor', 'SGLT2 inhibitor or DPP4 inhibitor', 'injectable insulin daily combined with or without no more than two oral antidiabetic agents']","['ANP and BNP levels', 'weight', 'levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP', 'sodium concentrations', 'plasma levels of atrial natriuretic peptide and brain natriuretic peptide', 'ANP levels', 'HbA1c and blood glucose levels', 'HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure', 'lower HbA1c levels', 'ANP levels, BNP levels, systolic blood pressure and weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",56.0,0.0715293,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","[{'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: show_clancy@foxmail.com.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: gqw9299@163.com.'}, {'ForeName': 'Gu', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: feifeigalt@163.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: happy_yuanlu@126.com.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: shygu@njmu.edu.cn.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: zhangying932@163.com.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.07.1113']
2506,32823720,Comparison of Opioid-Free Anesthesia Versus Opioid-Containing Anesthesia for Elective Laparoscopic Surgery (COFA: LAP): A Protocol Measuring Recovery Outcomes.,"The administration of opioids is a central element in contemporary anesthetic techniques in Australia; however, opioids have a range of side effects. As an alternative, opioid-free anesthesia (OFA) is an emerging mode of anesthesia intended to avoid these side effects. This study is the first to publish the use of OFA in Australia and is conducted in a regional Queensland Health Service. The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40). Participant outcomes to be measured include: Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS). The findings may challenge the essentiality of opioids in the peri-operative period, which in turn would influence the future intra-operative management of surgical patients. Ultimately, a reduction in anesthesia-associated opioid use will support a more general decline in opioid use.",2020,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,['patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40'],"['Opioid-Containing Anesthesia', 'opioids', 'opioid-free anesthesia (OFA', 'OFA', 'COFA: LAP', 'Elective Laparoscopic Surgery', 'Opioid-Free Anesthesia']",[' Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0520483', 'cui_str': 'Ligation of fallopian tube'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",,0.0797404,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Eidan', 'Affiliation': 'Anesthetic Department, Bundaberg Hospital, Wide Bay Hospital and Health Service, Bundaberg 4670, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ratsch', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Burmeister', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}]",Methods and protocols,['10.3390/mps3030058']
2507,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
2508,32822528,The Effect of Metabolic Syndrome Status on Lung Function and Patient-reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.,"Background


Concurrent chronic obstructive pulmonary disease (COPD) and metabolic syndrome (MetS) represent an important clinical phenotype with overlapping symptomology. The effect of MetS in COPD patients was assessed following treatment with nebulized glycopyrrolate (GLY; administered via eFlow® Closed System Nebulizer).
Methods


Posthoc analyses were performed on pooled lung function, patient-reported outcome (PRO) and safety data by MetS status from patients treated with placebo, GLY 25 and 50 mcg twice daily in two 12-week studies (GOLDEN 3 and 4; N=1293). Patients with MetS were characterized as having ≥ 3 of hypertension, hyperlipidemia, diabetes, body mass index (BMI) > 30 kg/m 2  risk factors. The results are presented for the Food and Drug Administration-approved GLY 25 mcg dose.
Results


A total of25% of patients met MetS criteria.At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second. In the non-MetS group, significant improvements occurred in the St George's Respiratory Questionnaire (MetS: -2.28,  p =0.157; non-MetS: -3.71) and Evaluating Respiratory Symptoms in COPD tool (MetS: 0.42,  p =0.574; non-MetS: -1.61) total scores. Incidence of adverse events was similar with GLY versus placebo regardless of MetS status.
Conclusion


GLY was well-tolerated and significantly improved lung function regardless of MetS status, while significant PRO improvements occurred in non-MetS patients. These results highlight the importance of comorbidities on bronchodilator responses and patient symptoms in COPD patients.",2020,"At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second.","['Patients with COPD Receiving', 'COPD patients', 'Patients with MetS were characterized as having ≥ 3 of hypertension, hyperlipidemia, diabetes, body mass index (BMI) > 30 kg/m 2  risk factors']","['placebo, GLY', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['lung function regardless of MetS status', ""St George's Respiratory Questionnaire (MetS"", 'cardiovascular risk factors, and MetS-specific risk factors', 'PRO improvements', 'Incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0476815,"At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Carlin', 'Affiliation': 'Sleep Medicine and Lung Health Consultants, LLC, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.4.2020.0145']
2509,32824425,Changes in the Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results from a Randomized Controlled Trial.,"Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment ( p  < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different ( p  < 0.05). Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05). The mean form factor, Shannon index, and  Pediococcus  population were significantly increased in the post-NF group compared with those in the post-ND group ( p  < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with  Enhydrobacter , whereas  Enterobacteriaceae  was negatively correlated with TEWL in the NF group. These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.",2020,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).",[],"['cosmetic serum containing galacto-oligosaccharides (GOS', 'GOS', 'Prebiotic treatment', 'placebo']","['wrinkle depth and  Staphylococcus aureus  population', 'water-holding capacity', 'mean form factor, Shannon index, and  Pediococcus  population', 'transepidermal water loss (TEWL) and the erythema index', 'skin water-holding capacity']",[],"[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030762', 'cui_str': 'Pediococcus'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",60.0,0.0290086,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).","[{'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Hong', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Yang Hee', 'Initials': 'YH', 'LastName': 'Hong', 'Affiliation': ""Department of Beauty Art, Suwon Women's University, Suwon 16632, Korea.""}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Jung', 'Affiliation': 'Department of Home Economic Education, Jeonju University, Jeonju 55069, Korea.'}, {'ForeName': 'Kyungae', 'Initials': 'K', 'LastName': 'Jo', 'Affiliation': 'BK21Plus, College of Health Science, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hyung Joo', 'Initials': 'HJ', 'LastName': 'Suh', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}]",Journal of personalized medicine,['10.3390/jpm10030091']
2510,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance


A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective


To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions


In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants


Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures


The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results


Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance


In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
2511,32721580,Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.,"Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. 1 , 2  In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19. 3  In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported. 4 , 5  In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0). 6  Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.",2020,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"['adults admitted to hospital with severe COVID-19 (n\xa0= 237', 'healthy volunteers and patients with COVID-19', 'recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0', 'patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection']",['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.110012,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Thuriot', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Durrieu', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.050']
2512,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
2513,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
2514,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
2515,32828737,Randomized Trial Comparing Consumption of Military Rations to Usual Intake for 21 Consecutive Days: Nutrient Adequacy and Indicators of Health Status.,"BACKGROUND


The US military Meal, Ready-to-Eat food ration is approved as a nutritionally adequate sole source of nutrition for ≤21 days. However, the ration continuously evolves, requiring periodic reassessment of its influence on nutritional status and health.
OBJECTIVE


To determine the effects of consuming the US Armed Services Meal, Ready-to-Eat ration for 21 days, relative to usual diets, on nutrient intake, and indicators of nutritional status and cardiometabolic health.
DESIGN


Parallel-arm, randomized, controlled trial, secondary analysis.
PARTICIPANTS


Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March 2017.
INTERVENTION


Participants were randomized to consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE).
MAIN OUTCOME MEASURES


Nutrient intake (absolute and adjusted) throughout the study period, and indicators of nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels) before (Day 0), during (Day 10 through Day 21), and after (Day 31) the intervention period.
STATISTICAL ANALYSIS PERFORMED


Between-group differences over time were assessed using marginal models. Models for nutritional status and cardiometabolic health indicators were adjusted for age, initial body mass index, and baseline value of the dependent variable.
RESULTS


Energy-adjusted fiber; polyunsaturated fatty acids; vitamins A, thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes all increased in MRE during the intervention and were higher compared with CON (P<0.05), whereas relative protein intake decreased and was lower (P<0.05). Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05). No statistically significant effects of diet on any other nutritional status or cardiometabolic health indicators were observed.
CONCLUSIONS


Findings demonstrate that a Meal, Ready-to-Eat ration diet can provide a more micronutrient-dense diet than usual dietary intake aiding in maintenance of nutritional status over 21 days.",2020,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"['Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March\xa02017']","['consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE', 'Consumption of Military Rations']","['nutritional status or cardiometabolic health indicators', 'Serum triglyceride concentrations', 'relative protein intake', 'MRE relative to CON', 'thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes', 'nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels']","[{'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",60.0,0.0422149,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"[{'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'McClung', 'Affiliation': ''}, {'ForeName': 'Nicholes J', 'Initials': 'NJ', 'LastName': 'Armstrong', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Hennigar', 'Affiliation': ''}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Staab', 'Affiliation': ''}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': ''}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.06.018']
2516,32830368,"Time-varying effects of 'optimized smoking treatment' on craving, negative affect and anhedonia.","AIMS


To identify when smoking cessation treatments affect craving, negative affect and anhedonia, and how these symptoms relate to abstinence, to help evaluate the effects of particular intervention components in multi-component treatments and accelerate treatment refinement.
DESIGN


Secondary analysis of data from a two-arm randomized controlled trial.
SETTING


Seven primary care clinics in Wisconsin, United States.
PARTICIPANTS


Adult primary care patients who smoked daily (n = 574).
INTERVENTION AND COMPARATOR


Intervention was abstinence-optimized treatment (A-OT, n = 276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD and extensive psychosocial support. The comparator was recommended usual care (RUC, n = 298), comprising brief counseling and 8 weeks of nicotine patch post-TQD.
MEASUREMENTS


Time-varying effect models examined dynamic effects of A-OT (versus RUC) on the primary outcomes of nightly cigarette craving, negative affect and anhedonia from 1 week pre- to 2 weeks post-TQD. Exploratory models examined within-person relations between nicotine medication use and same-day symptom ratings. Secondary logistic regression analyses examined associations between post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence.
FINDINGS


A-OT significantly suppressed pre- and post-TQD craving (β = -0.27 to -0.46 across days) and post-TQD anhedonia (β = -0.24 to -0.38 across days), relative to RUC. Within individuals, using patches was associated with lower negative affect in RUC (β = -0.42 to -0.52), but not in A-OT. Using more mini-lozenges was associated with greater craving (β = 0.04-0.07) and negative affect (β = 0.03-0.05) early, and with lower anhedonia (β = -0.06 to -0.12) later. Greater post-TQD craving (OR = 0.68) and anhedonia (OR = 0.85) predicted lower odds of abstinence 1 month post-TQD.
CONCLUSION


Time-varying effect models showed that a multi-component treatment intervention for smoking cessation suppressed significant withdrawal symptoms more effectively than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.",2020,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","['Seven primary care clinics in Wisconsin, USA', 'Adult primary care patients who smoked daily (N=574']","['nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD, and extensive psychosocial support', 'nicotine patch post-TQD']","['post-TQD anhedonia', 'nightly cigarette craving, negative affect, and anhedonia', 'post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence', 'Craving, Negative Affect, and Anhedonia', 'Greater post-TQD craving', 'anhedonia', 'Time-varying effect models examined dynamic effects of A-OT (versus RUC', 'pre- and post-TQD craving', 'RUC', 'craving pre- and post-target quit day (TQD) and anhedonia post-TQD', 'greater craving', 'lower anhedonia', 'withdrawal symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.0239201,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15232']
2517,32838701,Effect of an integrated neonatal care kit on cause-specific neonatal mortality in rural Pakistan.,"BACKGROUND


In 2018, Pakistan had the world's highest neonatal mortality rate. Within Pakistan, most neonatal deaths occur in rural areas where access to health facilities is limited, and robust vital registration systems are lacking. To improve newborn survival, there is a need to better understand the causes of neonatal death in high burden settings and engage caregivers in the promotion of newborn health.
OBJECTIVE


To describe the causes of neonatal death in a rural area in Pakistan and to estimate the effect of an integrated neonatal care kit (iNCK) on cause-specific neonatal mortality.
METHODS


We analyzed data from a community-based, cluster-randomized controlled trial of 5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015. In intervention clusters, Lady Health Workers (LHW) delivered the iNCK and education on its use to pregnant women while control clusters received the local standard of care. The iNCK included interventions to prevent and identify signs of infection, identify low birthweight (LBW), and identify and manage hypothermia. Verbal autopsies were attempted for all deaths. The primary outcome was cause-specific neonatal mortality.
RESULTS


Verbal autopsies were conducted for 84 (57%) of the 147 reported neonatal deaths. The leading causes of death were infection (44%), intrapartum-related complications (26%) and prematurity/LBW (20%). There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
CONCLUSION


The major causes of neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths. The iNCK did not significantly reduce any cause-specific neonatal mortality.",2020,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","['rural Pakistan', '5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015']","['integrated neonatal care kit', 'Lady Health Workers (LHW) delivered the iNCK and education', 'integrated neonatal care kit (iNCK']","['infection', 'low birthweight (LBW), and identify and manage hypothermia', 'neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths', 'neonatal deaths', 'neonatal mortality due to prematurity/LBW', 'intrapartum-related complications', 'newborn survival', 'neonatal mortality rate', 'cause-specific neonatal mortality', 'Verbal autopsies']","[{'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0004398', 'cui_str': 'Autopsy examination'}]",5286.0,0.166932,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Duby', 'Affiliation': 'Department of Pediatrics, McGill University , Montreal, Canada.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Pell', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Afsah', 'Initials': 'A', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Farrar', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Diego G', 'Initials': 'DG', 'LastName': 'Bassani', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Masawar', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Sajid', 'Initials': 'S', 'LastName': 'Soofi', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'Morris', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}]",Global health action,['10.1080/16549716.2020.1802952']
2518,32830200,Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer - translational results from the AIO-PK0104 Phase 3 study.,"BACKGROUND


Gram-negative bacteria mediated gemcitabine resistance in pre-clinical models. We determined if intratumoural lipopolysaccharide (LPS) detection by immunohistochemistry is associated with outcome in advanced pancreatic ductal adenocarcinoma (PDAC) treated with gemcitabine and non-gemcitabine containing 1st-line chemotherapy.
METHODS


We examined LPS on tumour tissue from 130 patients treated within the randomised AIO-PK0104 trial and a validation cohort (n = 113) and analysed the association of LPS detection to patient outcome according to treatment subgroups.
RESULTS


In 24% of samples from the AIO-PK0104 study LPS was detected; in LPS-positive patients median OS was 4.4 months, compared to 7.3 months with LPS negative tumours (HR 1.732, p = 0.010). A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478). Within the validation cohort, the LPS positivity rate was 23%, and LPS detection was correlated with impaired OS in the gemcitabine subgroup (n = 94; HR 1.993, p = 0.008) whereas no difference in OS was observed in the non-gemcitabine subgroup (n = 19; HR 2.596, p = 0.219).
CONCLUSIONS


The detection of intratumoural LPS as surrogate marker for gram-negative bacterial colonisation may serve as a negative predictor for gemcitabine efficacy in advanced PDAC.
CLINICAL TRIAL REGISTRY


The Clinical trial registry identifier is NCT00440167.",2020,"A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478).","['advanced pancreatic ductal adenocarcinoma (PDAC) treated with', '130 patients treated within the randomised AIO-PK0104 trial and a validation cohort (n\u2009=\u2009113']","['gemcitabine', 'Bacterial lipopolysaccharide', 'gemcitabine and non-gemcitabine', 'LPS']","['LPS positivity rate', 'OS', 'LPS detection']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",130.0,0.0321348,"A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Guenther', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kruger', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Christoph Benedikt', 'Initials': 'CB', 'LastName': 'Westphalen', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Bergwelt-Baildon', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Department of Internal Medicine II, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ormanns', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany. steffen.ormanns@med.uni-muenchen.de.'}]",British journal of cancer,['10.1038/s41416-020-01029-7']
2519,32828135,Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.,"The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P  = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.",2020,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","['patients with COVID-19', 'COVID-19', 'three major university hospitals in Egypt', 'One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent']","['HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'HCQ']","['mechanical ventilation', 'mortality rates', 'safety and efficacy', 'recovery within 28 days, need for mechanical ventilation, or death', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",194.0,0.126559,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ehab Fawzy', 'Initials': 'EF', 'LastName': 'Abdo', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Samir', 'Initials': 'MS', 'LastName': 'Abd El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ghada N', 'Initials': 'GN', 'LastName': 'Serangawy', 'Affiliation': 'Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0873']
2520,32839221,"A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants.","RO7049389, an inhibitor of hepatitis B virus (HBV) capsid assembly, is being developed for the treatment of patients with chronic HBV infection. The objectives of this first-in-human study are to assess the safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A, and effect on QT of RO7049389 in healthy participants. Five components, single-ascending-dose (SAD) cohorts, multiple-ascending-dose (MAD) cohorts, food effect assessment, drug-drug interaction assessment, and concentration-QT analysis were integrated in one study (five-in-one). Participants randomly received a single dose of 150 to 2,500 mg RO7049389 or placebo in SAD cohorts ( n  = 41), or multiple doses of 200 to 800 mg RO7049389 or placebo in MAD cohorts ( n  = 42). A single doses of 450 mg RO7049389 was administered under fasted and fed condition. The microdose of midazolam was administered before and after multiple dosing of RO7049389. Safety and tolerability were monitored throughout the study. Serial blood and urine samples were collected for the PK analysis. RO7049389 was safe and well tolerated in healthy participants. Absorption and elimination of RO7049389 occurred rapidly in plasma with minimal recovery in urine. Greater than dose-proportional increases in plasma exposure were observed. Exposure of RO7049389 (450 mg) increased by ∼2-fold when administered with a high-fat meal. The inhibition effect of RO7049389 on CYP3A was weak (<20%). No effect on QT interval was observed at up to a single dose of 2,500 mg. RO7049389 displayed a favorable safety, tolerability and PK profile suitable for further clinical development. (This trial was registered at ClinicalTrials.gov with the identifier NCT02952924.).",2020,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"['patients with chronic HBV infection', 'healthy participants']","['RO7049389 or placebo', 'midazolam']","['plasma exposure', 'Serial blood and urine samples', 'Safety and tolerability', 'safety, tolerability, and pharmacokinetics', 'QT interval', 'safe and well tolerated', 'favorable safety, tolerability', 'concentration-QT analysis', 'safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}]",,0.0647484,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Early Development Safety, Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biostatistics, Roche Pharma Product Development Shanghai, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Bo', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China yuyan.jin@roche.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01323-20']
2521,32839843,Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis.,"In this post hoc analysis of the Denosumab Fracture Intervention Randomized Placebo-Controlled Trial (DIRECT) in Japanese postmenopausal women and men with osteoporosis, we evaluated the relationship between vertebral fracture risk and both bone mineral density (BMD) T-score and percent change after 24 months of denosumab treatment at total hip, femoral neck, and lumbar spine. Logistic regression analysis was performed and the proportion of treatment effect explained by BMD in vertebral fracture risk was estimated. The results demonstrate that both total hip BMD T-score and change can be strong predictors of subsequent fracture risk, and that total hip BMD change explained 73%, while T-score explained 23%, of the treatment effect. In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk. Furthermore, although lumbar spine BMD T-score was associated with vertebral fracture incidence, lumbar spine BMD change was inversely related to vertebral fracture risk. Because there was no relationship between lumbar spine BMD change and T-score at 24 months of denosumab treatment, and because there can be small undetectable vertebral deformities that may increase BMD values, these results suggest that lumbar spine BMD change is not a good surrogate for vertebral fracture risk assessment. It is suggested that both total hip BMD change and T-score can be good surrogates for predicting vertebral fracture risk in Japanese patients with osteoporosis under denosumab treatment.ClinicalTrials.gov identifier: NCT00680953.",2020,"In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk.","['Japanese postmenopausal women and men with osteoporosis', 'Japanese patients with osteoporosis under denosumab treatment', 'Japanese Postmenopausal Women and Men with Osteoporosis']","['Placebo', 'denosumab', 'Denosumab Treatment']","['vertebral fracture risk', 'femoral neck BMD change nor T-score', 'total hip BMD change', 'lumbar spine BMD change and T-score', 'BMD values', 'vertebral fracture incidence, lumbar spine BMD change', 'total hip BMD T-score', 'vertebral fracture risk and both bone mineral density (BMD) T-score', 'lumbar spine BMD T-score', 'total hip BMD change and T-score']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0191312,"In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan. okubo.naoki.d8@daiichisankyo.co.jp.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Hyogo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Kenkoin Clinic, Tokyo, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Osakabe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]",Calcified tissue international,['10.1007/s00223-020-00750-y']
2522,32840418,"Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma.","PURPOSE


To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo.
PATIENTS AND METHODS


Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function × the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ≥ 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥ 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as μTOX × TOX + TWiST, with μTOX calculated using EQ-5D-3L data.
RESULTS


The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  BRCA -mutant cohort (130 rucaparib  v  66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib  v  118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and  BRCA  wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib  v  54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ≥ 3 TEAEs, the difference in mean Q-TWiST (rucaparib  v  placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population,  BRCA -mutant cohort, HRD cohort, and  BRCA  wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ≥ 2 TEAEs also consistently favored rucaparib.
CONCLUSION


The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.",2020,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","['Patients With Recurrent Ovarian Carcinoma', 'Patients with platinum-sensitive, recurrent ovarian carcinoma']","['Rucaparib Maintenance Treatment', 'rucaparib versus placebo', 'placebo', 'rucaparib', 'Placebo']","['quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST', 'nausea, vomiting, fatigue, and asthenia', 'Mean QA-PFS', 'mean Q-TWiST', 'QA-PFS', 'EQ-5D questionnaire (EQ-5D-3L) index score function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.300562,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Oncology Center of Galicia, Doctor Camilo Veiras, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, St Lucia, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University, James Cancer Center, Columbus, OH.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clovis Oncology UK, Ltd., Cambridge, United Kingdom.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Mörk', 'Affiliation': 'Clovis Oncology Denmark, ApS, Copenhagen, Denmark.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Clovis Oncology Switzerland, GmBH, Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, and UCL Hospitals, London, United Kingdom.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03107']
2523,32833763,"3D Versus 4K Display System - Influence of ""State-of-the-art""-Display Technique on Surgical Performance (IDOSP-study) in Minimally Invasive Surgery: A Randomized Cross-over Trial.","OBJECTIVE


To evaluate if ""state-of-the-art"" 3D- versus 4K-display techniques could influence surgical performance.
BACKGROUND


High quality minimally invasive surgery is challenging. Therefore excellent vision is crucial. 3D display technique (3D) and 2D-4K technique (4K) are designed to facilitate surgical performance, either due to spatial resolution (3D) or due to very high resolution (4K).
METHODS


In randomized cross-over trial the surgical performance of medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC) was compared using 3D versus 4K display technique at a minimally invasive training Parkour.
RESULTS


One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC). The overall Parkour time (s) 3D versus 4K was 712.5 s ± 17.5 s versus 999.5 s ± 25.1 s (P < 0.001) for all levels of experience. It was (3D vs 4K) for MS (30 tasks) 555.4 s ± 28.9 s versus 858.7 s ± 41.6 s, (P < 0.0001), for NBC (42 tasks) 935.9 s ± 31.5 s versus 1274.1 s ± 45.1 s (P =< 0.001) and for BC (42 task) 646.3 s ± 30.9 s versus 865.7 s ± 43.7 s (P < 0.001). The overall number of mistakes was (3D vs 4K) 10.0 ± 0.5 versus 13.3 ± 0.7 (P < 0.001), for MS 8.9 ± 0.9 versus 13.1 ± 1.1 (P < 0.001), for NBC 12.45 ± 1.0 versus 16.7 ± 1.2 (P < 0.001) and for BC 8.8 ± 1.0 versus 10.0 ± 1.2 (P = 0.18). MS, BC, and NBC showed shorter performance time in 100% of the task with 3D (significantly in 6/7 tasks). For number of mistakes the effect was less pronounced for more experienced surgeons. The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


3D laparoscopic display technique optimizes surgical performance compared to the 4K technique. Surgeons benefit from the improved visualization regardless of their individual surgical expertise.",2020,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","['One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC', 'medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC', 'Minimally Invasive Surgery']",['3D display technique (3D) and 2D-4K technique (4K'],"['overall number of mistakes', 'MS, BC, and NBC showed shorter performance time', 'overall Parkour time (s']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",128.0,0.079681,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Bußhoff', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hedergott', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gietzelt', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Dieplinger', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Gynecology and Gynecologic Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Desdemona', 'Initials': 'D', 'LastName': 'Möller', 'Affiliation': 'Faculty of Management, Economics and Social Sciences, Department of Business Administration and Health Care Management, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Stippel', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004328']
2524,32833767,Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer.,"OBJECTIVE


To investigate if prolonged TTS after completed nCRT improves postoperative outcomes for esophageal and esophagogastric junction cancer.
SUMMARY OF BACKGROUND DATA


TTS has traditionally been 4-6 weeks after completed nCRT. However, the optimal timing is not known.
METHODS


A multicenter clinical trial was performed with randomized allocation of TTS of 4-6 or 10-12 weeks. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101).
RESULTS


In total 249 patients were randomized. There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603). There were no statistically significant differences between standard and prolonged TTS regarding anastomotic leak (P = 0.596), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548), and respiratory failure (P = 0.723). In the standard TTS arm 5 patients (4.3%) died within 90 days of surgery, compared to 4 patients (3.8%) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.234).
CONCLUSION


The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction, is not of major importance with regard to short-term postoperative outcomes.",2020,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","['Esophageal Cancer', 'esophageal and esophagogastric junction cancer', 'In total 249 patients']","['Prolonged Time to Surgery', 'nCRT', 'Neoadjuvant Chemoradiotherapy', 'TTS']","['standard and prolonged TTS regarding anastomotic leak', 'pneumonia', 'conduit necrosis', 'Surgical Morbidity and Mortality', 'Median length of hospital stay', 'overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay', 'Clavien-Dindo grade IIIb-V complications', 'respiratory failure', 'chyle leak', 'overall incidence of complications Clavien-Dindo grade II-V']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0008730', 'cui_str': 'Chyle'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",249.0,0.272683,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","[{'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Klevebro', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Rouvelas', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Halldestam', 'Affiliation': 'Department of Surgery, University Hospital of Linköping, Linköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Smedh', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Wallner', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Johansson', 'Affiliation': 'Department of Surgery, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gjermund', 'Initials': 'G', 'LastName': 'Johnsen', 'Affiliation': ""Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Eirik Kjus', 'Initials': 'EK', 'LastName': 'Aahlin', 'Affiliation': 'Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Hans-Olaf', 'Initials': 'HO', 'LastName': 'Johannessen', 'Affiliation': 'Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir Olav', 'Initials': 'GO', 'LastName': 'Hjortland', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bartella', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}]",Annals of surgery,['10.1097/SLA.0000000000004340']
2525,32833762,Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).,"OBJECTIVE


To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial.
BACKGROUND


While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival.
METHODS


Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695.
RESULTS


Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
CONCLUSIONS


This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.",2020,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","['Between March 2008 and November 2015', '115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial', '144 patients', 'Malignant Left-sided Colonic Obstruction', 'Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive']","['SBTS or ES', 'SBTS', 'stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES']","['obstruction', 'DFS', 'OS', 'TTP', 'overall (OS), time to progression (TTP), and disease-free survival (DFS', 'OS, TTP, and DFS']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0235328', 'cui_str': 'Obstruction of colon'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0460048', 'cui_str': 'Large bowel obstruction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",59.0,0.384575,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Arezzo', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Forcignanò', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Marco Augusto', 'Initials': 'MA', 'LastName': 'Bonino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Balagué', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Borghi', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giraudo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ghezzo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Passera', 'Affiliation': 'Department of Medical sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004324']
2526,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
2527,32840621,Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital: A Randomized Clinical Trial.,"Importance


Stress among health care professionals is well documented. The use of mindfulness-based interventions to reduce stress has shown promising results; however, the time commitment of typical programs can be a barrier to successful implementation in health care settings.
Objective


To determine the efficacy and feasibility of a brief mindfulness-based program to reduce stress during work hours among health care professionals.
Design, Setting, and Participants


This intent-to-treat randomized clinical trial was conducted among full-time health care professionals at the Clinical Center at the National Institutes of Health in Bethesda, Maryland, between September 2017 and May 2018. Participants were randomized to receive mindfulness-based self-care (MBSC) training or life-as-usual control. Data were analyzed from June 2018 to January 2020.
Interventions


The MBSC intervention included 5 weekly, 1.5-hour in-class mindfulness practice sessions.
Main Outcomes and Measures


Stress level was the primary outcome, assessed with the Perceived Stress Scale 10-Item version. Secondary outcomes included anxiety, burnout, positive and negative affect, mindfulness (trait and state), and self-care. Assessments were taken at baseline and at the end of the intervention (week 5) in the intervention and control groups, and at follow-up (week 13) in the intervention group to test for a maintenance effect. A postprogram evaluation was also obtained.
Results


Of 82 randomized participants, 78 who completed the study at week 5 were included in the modified intent-to-treat analysis (median [interquartile range] age, 32 [23-48] years; 65 [83%] women), including 43 participants in the MBSC group and 35 participants in the control group. At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001). Burnout, negative affect, and trait mindfulness levels did not differ between groups. Changes within the MBSC group through follow-up included sustained reductions in stress (change, -6.14; 95% CI, -7.84 to -4.44; P < .001), anxiety (change, -1.46; 95% CI, -1.97 to -0.94; P < .001), trait mindfulness (change, 0.63; 95% CI, 0.36 to 0.90; P < .001), and state mindfulness (change, 1.89; 95% CI, 1.39 to 2.39; P < .001).
Conclusions and Relevance


This randomized clinical trial found that this brief mindfulness-based intervention was an effective and feasible means to reduce stress in health care professionals. Larger studies are needed to assess the effects on clinical care and patient outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT03781336.",2020,"At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001).","['full-time health care professionals at the Clinical Center at the National Institutes of Health in Bethesda, Maryland, between September 2017 and May 2018', 'Data were analyzed from June 2018 to January 2020', 'Health Care Professionals at a US Biomedical Research Hospital', '82 randomized participants, 78 who completed the study at week 5 were included in the modified intent-to-treat analysis (median [interquartile range] age, 32 [23-48] years; 65 [83%] women), including 43 participants in the MBSC group and 35 participants in the control group']","['MBSC', 'brief mindfulness-based program', 'mindfulness-based self-care (MBSC) training or life-as-usual control', 'Brief Mindfulness-Based Program']","['state mindfulness', 'trait mindfulness', 'mindful self-care', 'anxiety, burnout, positive and negative affect, mindfulness (trait and state), and self-care', 'Perceived Stress Scale 10-Item version', 'trait mindfulness levels', 'anxiety', 'levels of stress']","[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0005540', 'cui_str': 'Research, Biomedical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",82.0,0.110778,"At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001).","[{'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Ameli', 'Affiliation': 'National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ninet', 'Initials': 'N', 'LastName': 'Sinaii', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'West', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Luna', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Panahi', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zoosman', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Rusch', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13424']
2528,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
2529,32841412,Preliminary clinical evaluation of traditional and a new digital PEEK occlusal splints for the management of sleep bruxism.,"OBJECTIVE


To compare the manual time and preliminary clinical effects between the digital manufactured occlusal splints for sleep bruxism patients with those of traditional hard splints.
METHODS


Sixteen individuals (18 to 44 y/o) with clinically diagnosed sleep bruxism were selected based on the inclusion criteria. All patients were divided into two groups, and a random control method was applied. Digital splints (test group) were designed and milled using CAD/CAM. Hard splints (control group) were made of transparent acrylic resin in laboratory office. The manual time spent including impression obtaining, splint production and clinical occlusal adjustment was recorded. A visual analog scale was used to report the subjective evaluations. The maximum depth loss and volumetric loss of the occlusal surface of splints in posterior tooth were measured. SPSS software was used for statistical analysis (P = .05).
RESULTS


Comparing with control group, the manual time spent in test group was significantly less in all of three procedures (P < .001). The VAS scores for retention were not significantly different (P = .086), but the wearing comfort scores of test group were significantly higher (P < .001). Both maximum depth loss (P = .007) and volumetric loss in test group were significantly less than control group (P = .005).
CONCLUSION


In the current study, the digitally manufactured splints exhibit significantly improved comfort and time efficiency than traditional hard splints. Moreover, the new milling material (PEEK) has better wear resistance than acrylic resins.",2020,"Both maximum depth loss (p = 0.007) and volumetric loss in test group were significantly less than control group (p = 0.005).
","['Sixteen individuals (18 to 44 y/o) with clinically diagnosed sleep bruxism were selected based on the inclusion criteria', 'sleep bruxism patients with those of traditional hard splints']","['transparent acrylic resin', 'Digital splints', 'digital manufactured occlusal splints', 'new milling material (PEEK']","['manual time spent including impression obtaining, splint production and clinical occlusal adjustment', 'maximum depth loss and volumetric loss of the occlusal surface of splints in posterior tooth', 'VAS scores for retention', 'comfort and time-efficiency', 'volumetric loss', 'manual time spent', 'wearing comfort scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0341000', 'cui_str': 'Occlusal adjustment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.023296,"Both maximum depth loss (p = 0.007) and volumetric loss in test group were significantly less than control group (p = 0.005).
","[{'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Implantology, Yinchuan Stomatology Hospital, Yinchuan, China.'}, {'ForeName': 'Yunsong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, China.'}]",Journal of oral rehabilitation,['10.1111/joor.13083']
2530,32842013,"Pre-emptive topical lidocaine 5% plaster for prevention of post-craniotomy pain: a protocol for a multicentred, randomized, triple-blind, placebo-controlled clinical trial.",,2020,,[],"['placebo', 'lidocaine']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",[],,0.530178,,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Peking University Third Hospital, Center for Precision Neurosurgery and Oncology, Peking University Health Science Center, Beijing 100191, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001066']
2531,32842583,Benefit of Wearing an Activity Tracker in Sarcoidosis.,"Sarcoidosis causes many disabling symptoms, including fatigue and exercise limitations, which have been shown to improve by physical activity programs. The aim of this study was to estimate the effect of continuous activity monitoring using an electronic activity tracker (AT) on exercise performance and fatigue of sarcoidosis patients, compared to controls (cohort study), and the effect of additional personal coaching (randomized trial) over a period of 3 months. Fifty-four sarcoidosis patients received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). A historical group of sarcoidosis patients (Group II;  n  = 41) who did not follow a physical activity program served as controls. Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3). Patients with coaching (Group Ia) showed greater improvement of exercise capacity over time than patients without coaching (Group Ib) as shown by the Steep Ramp Test results (watts: ∆20.2 ± 33.8 versus ∆5.7 ± 26.4; and SRT, VO 2 max, % predicted: ∆1.6 ± 2.6 versus ∆0.7 ± 2.3). Sarcoidosis patients wearing an AT achieved improvement of exercise performance and reduction of fatigue. We therefore recommend encouraging sarcoidosis patients to wear an AT to stimulate physical activity and reduce fatigue. The additional benefit of coaching needs to be explored in future studies.",2020,"Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3).",[],"['continuous activity monitoring using an electronic activity tracker (AT', 'AT', 'sarcoidosis patients (Group II;  n  = 41) who did not follow a physical activity program served as controls', 'additional personal coaching']","['exercise performance and reduction of fatigue', 'fatigue levels', 'exercise capacity', 'Exercise performance']",[],"[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}]",54.0,0.039776,"Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3).","[{'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Drent', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'Elfferich', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Breedveld', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Jolanda De', 'Initials': 'J', 'LastName': 'Vries', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Strookappe', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}]",Journal of personalized medicine,['10.3390/jpm10030097']
2532,32842705,Increased First Pass Success with C-MAC Videolaryngoscopy in Prehospital Endotracheal Intubation-A Randomized Controlled Trial.,"Endotracheal intubation (ETI) with direct view laryngoscopy (DL) is the gold standard for airway management. Videolaryngoscopy (VL) can improve glottis visualization, thus facilitating ETI. The aim of this monocentric, randomized, prospective study on a physician staffed German air ambulance is to compare DL and VL for ETI in terms of number of attempts and time as well as visualization of the glottis in a prehospital setting in a physician-based rescue system in adult patients. A power analysis was performed à priori. We used consecutive on-scene randomization with a sealed envelope system for the DL and VL-group. Successful ETI with first pass success was significantly more frequent with VL than DL and three seconds faster. The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL. Regarding improved first pass success in ETI with the VL, we would recommend the use of VL for prehospital airway management in physician-based rescue systems.",2020,The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL.,['adult patients'],"['Endotracheal intubation (ETI) with direct view laryngoscopy (DL', 'Videolaryngoscopy (VL']",['percentage of glottis opening and the Cormack & Lehane classification'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",,0.040486,The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Macke', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Gralla', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Winkelmann', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Jan-Dierk', 'Initials': 'JD', 'LastName': 'Clausen', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Haertle', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krettek', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9092719']
2533,32842722,"The relative analgesic value of a femoral nerve block versus adductor canal block following total knee arthroplasty: a randomized, controlled, double-blinded study.","BACKGROUND


Multiple comparative studies report that adductor canal blocks provide similar pain relief to femoral nerve blocks following total knee arthroplasty. However, adductor canal blockade fails to anesthetize several important femoral nerve branches that contribute to knee innervation. We sought to clarify this anatomic discrepancy by performing both blocks in sequence, using patients as their own controls. We hypothesized that patients would experience additional pain relief following a superimposed femoral nerve block, demonstrating that these techniques are not equivalent.
METHODS


Sixteen patients received continuous adductor canal block before undergoing knee arthroplasty under general anesthesia. In the recovery room, patients reported their pain score on a numeric scale of 0-10. Once a patient reached a score of five or greater, he/she was randomized to receive an additional femoral nerve block using 2% chloroprocaine or saline sham, and pain scores recorded every 5 min for 30 min. Patients received opioid rescue as needed. Anesthesiologists performing and assessing block efficacy were blinded to group allocation.
RESULTS


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 min after the femoral block (2.0 vs. 5.5, P = 0.0001). Patients receiving chloroprocaine also required significantly fewer morphine equivalents during the 30 min post-femoral block (1.0 vs. 4.5 mg, P = 0.03).
CONCLUSIONS


Adductor canal block is a useful technique for postoperative pain following total knee arthroplasty, but it does not provide equivalent analgesic efficacy to femoral nerve block. Future studies comparing efficacy between various block sites along the thigh are warranted.",2020,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).",['total knee arthroplasty'],"['additional femoral nerve block using 2% chloroprocaine', 'femoral nerve block versus adductor canal block', 'adductor canal blocks', 'continuous adductor canal block prior to undergoing total knee arthroplasty under general anesthesia', 'chloroprocaine']","['pain score', 'morphine equivalents', 'pain scores', 'median pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.56845,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Gadsden', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sata', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Bullock', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grant', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dooley', 'Affiliation': 'Department of Anesthesiology, University of North Carolina Medical Center, University of North Carolina, Chapel Hill, NC, USA.'}]",Korean journal of anesthesiology,['10.4097/kja.20269']
2534,32851644,"The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.","OBJECTIVE


To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial.
METHODS


Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes.
RESULTS


The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo.
CONCLUSIONS


The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).",2020,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","['Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days', 'Patients']","['placebo', 'Migraine Prevention', 'erenumab 70\xa0mg (n\xa0=\xa0312), erenumab 140\xa0mg (n\xa0=\xa0318), or placebo']","['mean MMD and MSMD', 'disability', 'changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes', 'MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.137358,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': 'Neuro Center, St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Headache,['10.1111/head.13929']
2535,32842769,Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial.,"Objectives:  To compare the safety and efficacy of holmium laser enucleation of prostate (HoLEP)  vs  bipolar plasmakinetic resection of prostate (BPRP) in the management of large-sized (≥75 g) benign prostatic hyperplasia (BPH).  Methods:  This randomized-controlled trial recruited 145 symptomatic BPH patients who had failed medical management, and who had undergone either HoLEP (Versa pulse ®  100 W;  n  = 73) or BPRP (AUTOCON ®  II 400 ESU;  n  = 72). Both groups were compared using the Mann-Whitney, chi-square, Student- t , or Fisher exact tests as appropriate. Preoperative  vs  postoperative findings (24 months) were compared using paired  t -test or Wilcoxon signed-rank test.  Results:  The two groups were comparable for most preoperative findings including prostate size ( p  = 0.629), although HoLEP included more patients on anticoagulants ( p  = 0.001). HoLEP was associated with significantly less operative duration ( p  < 0.001), hemoglobin loss ( p  < 0.001), catheterization duration ( p  = 0.009), and hospital stay ( p  < 0.001). There was no significant difference in total complications ( p  = 0.291) and each separate complication. Blood transfusion was reported only with BPRP ( p  = 0.058). At 24 months of follow-up, there was significant improvement in all the parameters in each group (International Prostate Symptom Score [IPSS], maximum urinary flow rate [Q max ] ,  quality of life [QoL], and postvoid residual urine [PVRU];  p  < 0.001). There was no significant difference between both groups in postoperative IPSS ( p  = 0.08), Q max  ( p  = 0.051), QoL ( p  = 0.057), or PVRU ( p  = 0.069). There was significantly better percentage improvement of both IPSS ( p  = 0.006) and QoL ( p  = 0.025) in HoLEP. HoLEP and smaller removed (resected or enucleated) tissues were associated with a reduction in the primary outcomes (hemoglobin loss and operative duration) in logistic regression analysis.  Conclusion:  HoLEP showed better safety profile with significantly less operative duration, hemoglobin loss, hospital stay, and catheterization duration. Although both procedures were effective, HoLEP showed significantly better percentage improvement of both IPSS and QoL. ClinicalTrials.gov Identifier: NCT04143399.",2020,"There was no significant difference between both groups in postoperative IPSS(p=0.08), Qmax(p=0.051), QoL(p=0.057), or PVRU(p=0.069).There was significantly better percentage improvement of both IPSS(p=0.006) and QoL(p=0.025) in HoLEP.","['Patients with Large Volume Benign Prostatic Hyperplasia', '145 symptomatic BPH patients who had failed medical management, who underwent either HoLEP (Versa pulse®100W) (n=73) or BPRP (AUTOCON® II 400 ESU) (n= 72', 'large sized (≥75gm) benign prostatic hyperplasia (BPH']","['HoLEP', 'bipolar plasmakinetic resection (BPRP', 'Holmium Laser Enucleation versus Bipolar Plasmakinetic Resection', 'holmium laser enucleation (HoLEP']","['total complications(p=0.291', 'safety and efficacy', 'operative duration', 'hemoglobin loss (p<0.001), catheterisation duration (p=0.009) and hospital stay', 'Blood transfusion', 'operative duration, hemoglobin loss, hospital stay and catheterization duration', 'IPSS and QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0180694', 'cui_str': 'Bovie'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",145.0,0.0490411,"There was no significant difference between both groups in postoperative IPSS(p=0.08), Qmax(p=0.051), QoL(p=0.057), or PVRU(p=0.069).There was significantly better percentage improvement of both IPSS(p=0.006) and QoL(p=0.025) in HoLEP.","[{'ForeName': 'Enmar Ibrahim', 'Initials': 'EI', 'LastName': 'Habib', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohammed Said', 'Initials': 'MS', 'LastName': 'ElSheemy', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hossam', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Morsy', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hussein Aly', 'Initials': 'HA', 'LastName': 'Hussein', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Yehia', 'Initials': 'AY', 'LastName': 'Abdelaziz', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Abdelazim', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Fathy', 'Affiliation': 'Urology Department, Kasr Al-Ainy Hospitals, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of endourology,['10.1089/end.2020.0636']
2536,32847423,A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers.,"OBJECTIVES


This study aimed to evaluate the bioequivalence, safety, tolerability and immunogenicity of the biosimilar trastuzumab (SIBP-01) compared to Herceptin®.
METHODS


In this Phase I randomized double-blind parallel-group trial, 100 healthy male volunteers were randomized in a1:1 ratio to receive a single 6 mg•kg-1 intravenous dose of SIBP-01 or Herceptin®. Serum concentrationswere analyzed using a validated ELISA.
RESULTS


The two groups had similar baseline characteristics. The geometric mean ratios (90% CI) of C max , AUC 0-t  and AUC inf  between the trial group and the reference group were 93.55%-104.27%, 91.98%-102.35% and 91.88%-102.34%, respectively; the geometric mean ratios (90% CI) of AUC 0-t  and AUC inf  in the sensitivity analysis were 92.29%-102.63% and 91.81%-102.16%, respectively. These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®. AEs were similar across all subjects in the SIBP-01 and Herceptin® arms, with treatment-related AEs reported by 72.00% and 80.00%, respectively. In each group, there was one AE that caused a subject to discontinue the study.
EXPERT OPINION


Trastuzumab (Herceptin®) is significantly more effective than chemotherapy in reducing exacerbations and tumor cell growth, and its adverse events are far lower than chemotherapy. Herceptin®is very expensive for most patients in China. The protein molecular primary structure of the biosimilar trastuzumab (SIBP-01) is consistent with Herceptin®, with highly similar high level structure, biologocal activity and purity.But there are few studies comparing the bioequivalence of SIBP-01 and Herceptin® in healthy subjects and cancer patients 2.
CONCLUSIONS


This study showed the PK similarity of SIBP-01 to Herceptin®. SIBP-01 was safe and well tolerated in healthy male volunteers, with no significant differences from the reference drug in safety or immunogenicity 4.",2020,"These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®.","['healthy Chinese male volunteers', 'healthy male volunteers', 'patients in China', '100 healthy male volunteers', 'healthy subjects and cancer patients']","['Herceptin®', 'SIBP-01 or Herceptin®', 'biosimilar trastuzumab (SIBP-01', 'potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®', 'Trastuzumab (Herceptin®', 'SIBP-01']","['safety or immunogenicity', 'C max , AUC 0-t  and AUC inf', 'bioequivalence, safety, tolerability and immunogenicity', 'geometric mean ratios', 'safe and well tolerated']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0338204', 'cui_str': 'Herceptin'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",100.0,0.102269,"These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University , Nanjing, Jiangsu, China.'}, {'ForeName': 'Shugang', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Pharmacy, Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'ZhongHuan', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Shan', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Bingyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Hongju', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University , Nanjing, Jiangsu, China.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1807935']
2537,32851418,Reply to Letter to Editor: Safety of one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,,2020,,[],['one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous'],[],[],"[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],,0.070912,,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04783-8']
2538,32845328,Comparative Effectiveness of Community-Based vs Clinic-Based Healthy Choices Motivational Intervention to Improve Health Behaviors Among Youth Living With HIV: A Randomized Clinical Trial.,"Importance


Youth living with HIV make up one-quarter of new infections and have high rates of risk behaviors but are significantly understudied. Effectiveness trials in real-world settings are needed to inform program delivery.
Objective


To compare the effectiveness of the Healthy Choices intervention delivered in a home or community setting vs a medical clinic.
Design, Setting, and Participants


This randomized clinical trial was conducted from November 1, 2014, to January 31, 2018, with 52 weeks of follow-up. Participants, recruited from 5 adolescent HIV clinics in the United States, were youths and young adults living with HIV aged 16 to 24 years who were fluent in English, were currently prescribed HIV medication, had a detectable viral load, and had used alcohol in the past 12 weeks. Individuals with an active psychosis that resulted in an inability to complete questionnaires were excluded. Data were analyzed from May to December, 2019.
Interventions


Participants were randomized to receive the Healthy Choices intervention in either a home or clinic setting. Four 30-minute individual sessions based on motivational interviewing to improve (1) medication adherence and (2) drinking behavior were delivered during 10 weeks by trained community health workers. In session 1, participants chose which behavior to discuss first. Using motivational interviewing strategies, the community health worker elicited motivational language, guided the development of an individualized change plan while supporting autonomy, delivered feedback, and addressed knowledge gaps. Session 2 focused on the second target behavior. In subsequent sessions, community health workers reviewed the individualized change plan, monitored progress, guided problem solving, and helped maintain changes made.
Main Outcomes and Measures


Primary outcomes were viral load and alcohol use change trajectories during 52 weeks of follow-up. Alcohol use severity and frequency were measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (scores range from 0 to 33, with higher scores indicating greater severity of alcohol-related problems) and number of drinks consumed each day over a 30-day period, with timeline followback.
Results


A total of 183 young people living with HIV (145 male [79.2%]; mean [SD] age, 21.4 [1.9] y) were randomized to the home setting (n = 90) or clinical setting (n = 93). Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks. However, the clinic group maintained gains, whereas those counseled at home had a significantly different and increasing trajectory during follow-up (unstandardized β = -0.07; 95% CI,-0.14 to -0.01; P = .02). A similar pattern was observed in ASSIST scores during follow-up, with reduced ASSIST scores in the clinic group (unstandardized β = -0.44; 95% CI,-0.81 to -0.07; P = .02).
Conclusions and Relevance


In this trial, the Healthy Choices intervention resulted in improvements in viral load and alcohol use over 12 months. Unexpectedly, the clinic setting outperformed home-based delivery for viral suppression. Although cross-sectional differences in ASSIST scores were nonsignificant, clinic delivery did improve the trajectory of ASSIST scores during follow-up. Thus, clinics may be the more effective site for interventions aimed at viral load reduction for young people living with HIV.
Trial Registration


ClinicalTrials.gov Identifier: NCT01969461.",2020,"Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks.","['November 1, 2014, to January 31, 2018, with 52 weeks of follow-up', 'Participants, recruited from 5 adolescent HIV clinics in the United States, were youths and young adults living with HIV aged 16 to 24 years who were fluent in English, were currently prescribed HIV medication, had a detectable viral load, and had used alcohol in the past 12 weeks', '183 young people living with HIV (145 male [79.2%]; mean [SD] age, 21.4 [1.9', 'Youth Living', 'Individuals with an active psychosis', 'young people living with HIV']","['Healthy Choices intervention', 'HIV', 'motivational interviewing to improve (1) medication adherence and (2) drinking behavior', 'Community-Based vs Clinic-Based Healthy Choices Motivational Intervention']","['viral load', 'trajectory of ASSIST scores', 'viral load and alcohol use change trajectories', 'ASSIST scores', 'viral load and alcohol use', 'undetectable viral load', 'Health Behaviors']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",183.0,0.109012,"Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Center for Translational Behavioral Science, Florida State University College of Medicine, Tallahassee.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robles', 'Affiliation': 'School of Social Work, Rutgers University, New Brunswick, New Jersey.'}, {'ForeName': 'Karen Kolmodin', 'Initials': 'KK', 'LastName': 'MacDonell', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Dinaj-Koci', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'College of Health Professions, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Lam', 'Affiliation': 'University of Windsor, Faculty of Arts, Humanities and Social Sciences, Windsor, Ontario, Canada.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, Teaneck, New Jersey.'}, {'ForeName': 'K Marie', 'Initials': 'KM', 'LastName': 'Sizemore', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York.'}, {'ForeName': 'Tyrel J', 'Initials': 'TJ', 'LastName': 'Starks', 'Affiliation': 'Health Psychology and Clinical Science Program, The Graduate Center, City University of New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14650']
2539,32847020,A 24-Week Physical Activity Intervention Increases Bone Mineral Content without Changes in Bone Markers in Youth with PWS.,"Bone mineral density (BMD) is of concern in Prader-Willi syndrome (PWS). This study compared responses to a physical activity intervention in bone parameters and remodeling markers in youth with PWS ( n  = 45) and youth with non-syndromic obesity (NSO;  n  = 66). Measurements occurred at baseline (PRE) and after 24 weeks (POST) of a home-based active games intervention with strengthening and jumping exercises (intervention group = I) or after a no-intervention period (control group = C). Dual x-ray absorptiometry scans of the hip and lumbar spine (L1-L4) determined BMD and bone mineral content (BMC). Bone markers included fasting bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen (CTx). Both I and C groups increased their hip BMD and BMC ( p  < 0.001). Youth with PWS-I increased their spine BMC from PRE to POST ( p  < 0.001) but not youth with PWS-C ( p  = 1.000). Youth with NSO (I and C) increased their spine BMC between PRE and POST (all  p  < 0.001). Youth with PWS showed lower BAP (108.28 ± 9.19 vs. 139.07 ± 6.41 U/L;  p  = 0.006) and similar CTx (2.07 ± 0.11 vs.1.84 ± 0.14 ng/dL;  p  = 0.193) than those with NSO regardless of time. Likely, the novelty of the intervention exercises for those with PWS contributed to gains in spine BMC beyond growth. Bone remodeling markers were unaltered by the intervention.",2020,Both I and C groups increased their hip BMD and BMC ( p  < 0.001).,"['youth with PWS ( n  = 45) and youth with non-syndromic obesity (NSO;  n  = 66', 'Youth with NSO ', 'Youth with PWS']","['Physical Activity Intervention', 'physical activity intervention']","['lower BAP', 'Bone mineral density (BMD', 'Bone remodeling markers', 'spine BMC', 'BMD and bone mineral content (BMC', 'hip BMD and BMC', 'fasting bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen (CTx']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0047830', 'cui_str': ""4,4'-thiodianiline""}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",,0.0340018,Both I and C groups increased their hip BMD and BMC ( p  < 0.001).,"[{'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Rubin', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Camila E', 'Initials': 'CE', 'LastName': 'Orsso', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Science, University of Alberta, 8602 112 Street, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Gertz', 'Affiliation': 'Obesity and Metabolism Unit, Western Human Nutrition Research Center, U.S. Department of Agriculture, 430 W Health Sciences Drive, Davis, CA 95616, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Science, University of Alberta, 8602 112 Street, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Diobel M', 'Initials': 'DM', 'LastName': 'Castner', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'Academic General Pediatrics, University of Florida, Gainesville, 1699 SW 16th Avenue, Gainesville, FL 32608, USA.'}]",Genes,['10.3390/genes11090984']
2540,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
2541,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
2542,31310895,Spotting Dalmatians: Children's ability to discover subordinate-level word meanings cross-situationally.,"Even when children encounter a novel word in the situation of a clear and unique referent, they are nevertheless faced with the problem of semantic uncertainty: when ""puziv"" refers to a co-present spotted dog, does the word mean Fido, Dalmatian, dog, animal, or entity? Here we explored the extent to which children (3-5 years of age) can reason about a novel word's meaning from information they have gathered cross-situationally, from a series of simple ostensive labeling events (""I see a puziv!""). Of particular interest were the conditions under which children arrive at a subordinate level meaning (e.g., Dalmatian) rather than a basic level meaning (e.g., dog). Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians). Experiment 2 showed that some children in this same age range (N = 20) can also arrive at subordinate level meanings cross-situationally when offered relatively minimal linguistic support (""It's a kind of dog.""). The findings are interpreted with respect to current theories of cross-situational word learning, and suggest that word meanings rather than sets of referential exemplars are tracked and used for cross-situational comparison.",2019,"Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians).",['children (3-5\u202fyears of age'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],[],32.0,0.0178649,"Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians).","[{'ForeName': 'Felix Hao', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': 'University of Nevada, Las Vegas, United States. Electronic address: hao.wang@unlv.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Trueswell', 'Affiliation': 'University of Pennsylvania, United States. Electronic address: trueswel@psych.upenn.edu.'}]",Cognitive psychology,['10.1016/j.cogpsych.2019.101226']
2543,32852531,Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.,"Importance


Novel approaches are needed to improve outcomes in patients with squamous cell carcinoma of the oral cavity. Neoadjuvant immunotherapy given prior to surgery and combining programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitors are 2 strategies to enhance antitumor immune responses that could be of benefit.
Design, Setting, and Participants


In this randomized phase 2 clinical trial conducted at 1 academic center, 29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019.
Interventions


Treatment was administered with nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab, 1 mg/kg, given week 1 only). Patients had surgery 3 to 7 days following cycle 2.
Main Outcomes and Measures


Safety and volumetric response determined using bidirectional measurements. Secondary end points included pathologic and objective response, progression-free survival (PFS), and overall survival. Multiplex immunofluorescence was used to evaluate primary tumor immune markers.
Results


Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38%]). The most common subsite was oral tongue (n = 16). Baseline clinical staging included patients with T2 (n = 20) or greater (n = 9) T stage and 17 patients (59%) with node-positive disease. Median time from cycle 1 to surgery was 19 days (range, 7-21 days); there were no surgical delays. There were toxic effects at least possibly related to study treatment in 21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients. One patient died of conditions thought unrelated to study treatment (postoperative flap failure, stroke). There was evidence of response in both the N and N+I arms (volumetric response 50%, 53%; pathologic downstaging 53%, 69%; RECIST response 13%, 38%; and pathologic response 54%, 73%, respectively). Four patients had major/complete pathologic response greater than 90% (N, n = 1; N+I, n = 3). With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
Conclusions and Relevance


Treatment with N and N+I was feasible prior to surgical resection. We observed promising rates of response in both arms, supporting further neoadjuvant studies with these agents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02919683.",2020,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","['patients with T2 (n\u2009=\u200920) or greater (n\u2009=\u20099) T stage and 17 patients (59%) with node-positive disease', 'Untreated Oral Cavity Squamous Cell Carcinoma', '29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019', 'patients with squamous cell carcinoma of the oral cavity', 'Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38', '21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients']","['Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab', 'Neoadjuvant immunotherapy', 'nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab']","['1-year progression-free survival', 'complete pathologic response', 'overall survival', 'Median time', 'pathologic and objective response, progression-free survival (PFS), and overall survival', 'Measures\n\n\nSafety and volumetric response determined using bidirectional measurements', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",14.0,0.271878,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vickie Y', 'Initials': 'VY', 'LastName': 'Jo', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Rawal', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Catalano', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lako', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Ciantra', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Weirather', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Criscitiello', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Luoma', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chau', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Lorch', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Kass', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Annino', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goguen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Beth-Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Hina J', 'Initials': 'HJ', 'LastName': 'Shah', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Wucherpfennig', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Rodig', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Uppaluri', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA oncology,['10.1001/jamaoncol.2020.2955']
2544,32852553,Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in Children With Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.,"Importance


Suboptimal adherence to oral mercaptopurine treatment in children with acute lymphoblastic leukemia (ALL) increases the risk of relapse. A frequently expressed barrier to adherence is forgetfulness, which is often overcome by parental vigilance.
Objective


To determine whether a multicomponent intervention, compared with education alone, will result in a higher proportion of patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older.
Design, Setting, and Participants


The adherence intervention trial was an investigator-initiated, multi-institutional, parallel-group, unblinded, randomized clinical trial conducted between July 16, 2012, and August 8, 2018, at 59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving mercaptopurine for maintenance. The date of final follow-up was January 2, 2019. Data analysis was performed from February to October 2019.
Interventions


Patients were randomized 1:1 to education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy. Four weeks of baseline adherence monitoring were followed with a 16-week intervention.
Main Outcomes and Measures


The primary end point was the proportion of patients with adherence rates 95% or higher over the duration of the intervention for all study participants, and for those younger than 12 years vs those aged 12 years and older.
Results


There were 444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group. Three hundred two patients (68.0%) were boys, 180 (40.5%) were non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity. The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08). Exploratory analyses showed that among patients aged 12 years and older, those in the intervention group had higher mean (SE) adherence rates than those in the education group (93.1% [1.1%] vs 90.0% [1.3%]; difference, 3.1%; 95% CI, 0.1%-6.0%; P = .04). In particular, among patients aged 12 years and older with baseline adherence less than 90%, those in the intervention group had higher mean (SE) adherence rates than those in the education group (83.4% [2.5%] vs 74.6% [3.4%]; difference, 8.8%; 95% CI, 2.2%-15.4%; P = .008). No safety concerns were identified.
Conclusions and Relevance


Although this multicomponent intervention did not result in an increase in the proportion of patients with ALL who had mercaptopurine adherence rates 95% or higher, it did identify a high-risk subpopulation to target for future adherence intervention strategies: adolescents with low baseline adherence.
Trial Registration


ClinicalTrials.gov Identifier: NCT01503632.",2020,"The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08).","['444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group', ""59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving"", 'non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity', 'children with acute lymphoblastic leukemia (ALL', 'Children With Acute Lymphoblastic Leukemia', 'Three hundred two patients (68.0%) were boys, 180 (40.5%) were', 'patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older']","['Daily Text Messaging and Directly Supervised Therapy Intervention', 'education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy', 'multicomponent intervention', 'mercaptopurine']","['proportion of patients with adherence rates', 'Oral Mercaptopurine Adherence', 'higher mean (SE) adherence rates', 'mercaptopurine adherence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.119137,"The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08).","[{'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hageman', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'F Lennie', 'Initials': 'FL', 'LastName': 'Wong', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatryand Human Behavior, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Duncan', 'Affiliation': 'Department of Psychology,West Virginia University, Morgantown.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Cancer and Blood Disease Institute, Division of Hematology/Oncology, Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Freyer', 'Affiliation': ""Cancer and Blood Disease Institute, Division of Hematology/Oncology, Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Mba', 'Affiliation': ""Department of Pediatric Hematology/Oncology, Driscoll Children's Hospital, Corpus Christi, Texas.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Aristizabal', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, San Diego.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walterhouse', 'Affiliation': ""Department of Pediatrics, Division of Hematology, Oncology, and Stem Cell Transplantation, Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Lew', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia.""}, {'ForeName': 'Pamela Helen-Heilge', 'Initials': 'PH', 'LastName': 'Kempert', 'Affiliation': ""Department of Hematology/Oncology, Miller Children's and Women's Hospital, Long Beach, California.""}, {'ForeName': 'Thomas Bennett', 'Initials': 'TB', 'LastName': 'Russell', 'Affiliation': 'Wake Forest Baptist Comprehensive Cancer Center, Wake Forest University Health Sciences, Winston-Salem, North Carolina.'}, {'ForeName': 'Rene Y', 'Initials': 'RY', 'LastName': 'McNall-Knapp', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': ""Department of Oncology, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Landier', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14205']
2545,32854206,Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results.,"BACKGROUND


the aim of this study was to assess the 2-year pulp survival of deep carious lesions in teeth excavated using a self-limiting protocol in a single-blind randomized controlled clinical trial.
METHODS


At baseline, 101 teeth with deep carious lesions in 86 patients were excavated randomly using self-limiting or control protocols. Standardized clinical examination and periapical radiographs of teeth were performed after 1- and 2-year follow-ups (REC 14/LO/0880).
RESULTS


During the 2-year period of the study, 24 teeth failed (16 and 8 at T12 and T24, respectively). Final analysis shows that 39/63 (61.9%) of teeth were deemed successful (16/33 (48.4%) and 23/30 (76.6%) in the control and experimental groups, respectively with a statistically significant difference (z score = 2.3,  p  = 0.021). Of teeth with severe and mild symptoms at T0, 42.9% and 36.7% respectively failed at T24 ( p  > 0.05). Within the self-limiting group, there was a lower success in premolars compared to molars ( p  < 0.05).
CONCLUSION


after 2 years, there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis. Molars showed higher success than premolars in teeth excavated using the self-limiting protocol. There was no statistically significant association between the outcome and the severity of symptoms at T0 (ClinicalTrials.gov NCT03071588).",2020,", there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis.","['101 teeth with deep carious lesions in 86 patients', 'patients with reversible pulpitis']",['Self-Limiting versus Rotary Subjective Carious Tissue Removal'],"['pulp survival rate', '2-year pulp survival']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",101.0,0.060801,", there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis.","[{'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Ali', 'Affiliation': 'Aesthetic and Restorative Dentistry Department, College of Dentistry, University of Baghdad, Baghdad 10001, Iraq.'}, {'ForeName': 'Farah Ben', 'Initials': 'FB', 'LastName': 'Thani', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Foschi', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': ""Conservative & MI Dentistry, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 25 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mannocci', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}]",Journal of clinical medicine,['10.3390/jcm9092738']
2546,32847927,Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II).,"INTRODUCTION


Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Over the past 20 years, a number of new drugs have been approved for National Health Service (NHS) use on the basis of information from short-term trials that demonstrate efficacy. These trials do not provide information about the longer term outcomes, which inform treatment policy. This trial will assess the long-term clinical and cost-effectiveness of the newer treatment levetiracetam and zonisamide.
METHODS AND ANALYSIS


This is a phase IV, multicentre, open-label, randomised, controlled clinical trial comparing new and standard treatments for patients with newly diagnosed epilepsy. Arm A of the trial randomised 990 patients with focal epilepsy to standard AED lamotrigine or new AED levetiracetam or zonisamide. Arm B randomised 520 patients with generalised epilepsy to standard AED sodium valproate or new AED levetiracetam. Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics. Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs. Patients are followed up for a minimum of 2 years. The primary outcome is time to 12-month remission from seizures. Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life. All primary analyses will be on an intention to treat basis. Separate analyses will be undertaken for each arm. Health economic analysis will be conducted from the perspective of the NHS to assess the cost-effectiveness of each AED.
ETHICS AND DISSEMINATION


This trial has been approved by the North West-Liverpool East REC (Ref. 12/NW/0361). The trial team will disseminate the results through scientific meetings, peer-reviewed publications and patient and public involvement.
TRIAL REGISTRATION NUMBERS


EudraCT 2012-001884-64; ISRCTN30294119.",2020,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"['520 patients with generalised epilepsy to', 'epilepsy', 'Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs', '990 patients with focal epilepsy to', 'Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics', 'patients with newly diagnosed epilepsy']","['standard AED sodium valproate or new AED levetiracetam', 'standard AED lamotrigine or new AED levetiracetam or zonisamide', 'levetiracetam and zonisamide', 'zonisamide']","['time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life', 'effectiveness and cost-effectiveness', 'time to 12-month remission from seizures']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",990.0,0.298206,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"[{'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'School of Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Phil E M', 'Initials': 'PEM', 'LastName': 'Smith', 'Affiliation': 'Department of Neurology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""Paediatric Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of Brain Sciences, Imperial College London Faculty of Medicine-South Kensington Campus, London, UK.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Pharmacology, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Anthony Guy', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK marjon01@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-040635']
2547,32853116,Chronic effects of muscle and nerve-directed stretching on tissue mechanics.,"Tissue-directed stretching interventions can preferentially load muscular or nonmuscular structures such as peripheral nerves. How these tissues adapt mechanically to long-term stretching is poorly understood. This randomized, single-blind, controlled study used ultrasonography and dynamometry to compare the effects of 12-wk nerve-directed and muscle-directed stretching programs versus control on maximal ankle dorsiflexion range of motion (ROM) and passive torque, shear wave velocity (SWV; an index of stiffness), and architecture of triceps surae and sciatic nerve. Sixty healthy adults were randomized to receive nerve-directed stretching, muscle-directed stretching, or no intervention (control). The muscle-directed protocol was designed to primarily stretch the plantar flexor muscle group, whereas the nerve-directed intervention targeted the sciatic nerve tract. Compared with the control group [mean; 95% confidence interval (CI)], muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3 m/s across muscles), decreased passive torque (-6.8 N·m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4 cm; 95% CI: 0.1-0.8). Muscle-directed intervention did not affect the SWV and size of sciatic nerve. Participants in the nerve-directed group showed a significant increase in ROM (+9.9°; 95% CI: 6.2-13.6) and a significant decrease in sciatic nerve SWV (> -1.8 m/s across nerve regions) compared with the control group. Nerve-directed intervention had no effect on the main outcomes at muscle and joint levels. These findings provide new insights into the long-term mechanical effects of stretching interventions and have relevance to clinical conditions where change in mechanical properties has occurred. NEW & NOTEWORTHY  This study demonstrates that the mechanical properties of plantar flexor muscles and sciatic nerve can adapt mechanically to long-term stretching programs. Although interventions targeting muscular or nonmuscular structures are both effective at increasing maximal range of motion, the changes in tissue mechanical properties (stiffness) are specific to the structure being preferentially stretched by each program. We provide the first in vivo evidence that stiffness of peripheral nerves adapts to long-term loading stimuli using appropriate nerve-directed stretching.",2020,"Compared with the control group (mean; 95% Confidence Interval), muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3m/s across muscles), decreased passive torque (-6.8N.m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4cm; 95% CI: 0.1 to 0.8).",['Sixty healthy adults'],"['nerve-directed, muscle-directed stretching, or no intervention (control', '12-week nerve-directed and muscle-directed stretching programs', 'muscle and nerve-directed stretching', 'Tissue-directed stretching interventions']","['SWV of triceps surae', 'main outcomes at muscle and joint levels', 'gastrocnemius medialis fascicle length', 'ROM', 'passive torque', 'SWV and size of sciatic nerve', 'maximal ankle dorsiflexion range of motion (ROM) and passive torque, shear wave velocity (SWV; an index of stiffness) and architecture of triceps surae and sciatic nerve', 'sciatic nerve SWV']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036394', 'cui_str': 'Structure of sciatic nerve'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",60.0,0.0723014,"Compared with the control group (mean; 95% Confidence Interval), muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3m/s across muscles), decreased passive torque (-6.8N.m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4cm; 95% CI: 0.1 to 0.8).","[{'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Sandro R', 'Initials': 'SR', 'LastName': 'Freitas', 'Affiliation': 'Universidade de Lisboa, Faculdade de Motricidade Humana, Centro Interdisciplinar de Estudo da Performance Humana (CIPER), Lisbon, Portugal.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Hug', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Sant', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lacourpaille', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Quillard', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McNair', 'Affiliation': 'Health and Rehabilitation Research Institute, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Nordez', 'Affiliation': 'Laboratory of Movement, Interactions, Performance (EA 4334), Faculty of Sport Sciences, Nantes, University of Nantes, France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00239.2019']
2548,32855201,Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.,"OBJECTIVES


To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.
DESIGN


Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.
SETTING


Orthopaedic departments in five public hospitals in Finland.
PARTICIPANTS


146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.
INTERVENTIONS


APM or placebo surgery (diagnostic knee arthroscopy).
MAIN OUTCOME MEASURES


We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).
RESULTS


There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.
CONCLUSIONS


APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01052233 and NCT00549172).",2020,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","['146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised', 'Orthopaedic departments in five public hospitals in Finland']","['Arthroscopic partial meniscectomy', 'APM or placebo surgery (diagnostic knee arthroscopy', 'placebo', 'arthroscopic partial meniscectomy (APM']","['progression of radiographic knee osteoarthritis', 'risk of developing radiographic knee osteoarthritis', 'Lysholm knee score', 'mechanical symptoms', 'Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score', 'radiographic knee osteoarthritis', 'knee pain', 'knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",146.0,0.385234,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","[{'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pihlajalinna Oyj, Tampere, Pirkanmaa, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Department of Orthopedics and Traumatology, Töölö Hospital, Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': 'Centre for Health and Social Economics - CHESS, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Itälä', 'Affiliation': 'Pohjola Hospital, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Joukainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kalske', 'Affiliation': 'Department of Orthopedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Nurmi', 'Affiliation': 'Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Jaanika', 'Initials': 'J', 'LastName': 'Kumm', 'Affiliation': 'Department of Medicine, Tartu Ulikool, Tartu, Tartumaa, Estonia.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Sillanpää', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kiekara', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Department of Orthopedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Clinical Epidemiology Unit, Orthopaedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo L N', 'Initials': 'TLN', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland teppo.jarvinen@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2020-102813']
2549,32857445,Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.,"BACKGROUND AND AIMS


Level of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.
DESIGN


Multicenter, parallel-group two-arm randomized controlled trial.
SETTING


Urban opioid treatment program (OTP) in the Bronx, New York, USA.
PARTICIPANTS


Daily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.
INTERVENTIONS


Individual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50).
MEASUREMENTS


The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million.
FINDINGS


Retention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up.
CONCLUSIONS


Among daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.",2020,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"['methadone-maintained smokers', 'smokers with opioid use disorder (OUD) receiving methadone treatment', 'Urban opioid treatment program (OTP) in the Bronx, New York, USA.\nPARTICIPANTS\n\n\nDaily smokers of ≥5 cigarettes/day', ""Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day""]","['varenicline', 'varenicline self-administered therapy', 'varenicline, either directly observed with methadone (DOT, n=50) or via unsupervised self-administration (SAT, n=50', 'varenicline directly observed therapy (DOT']","['varenicline adherence', '7-day point prevalence tobacco abstinence verified by expired CO<8 parts per million', 'Mean adherence', 'CO-verified abstinence', 'tobacco abstinence', 'adherence measured by pill count', 'varenicline adherence and smoking cessation rates', 'varenicline adherence and smoking cessation']","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.219717,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Nahvi', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Tangeria R', 'Initials': 'TR', 'LastName': 'Adams', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': ''}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15240']
2550,32859616,Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial.,"Dietary composition can influence systemic inflammation; higher levels of circulating inflammatory biomarkers are associated with increased risk of breast and other cancers. A total of 438 overweight/obese, healthy, postmenopausal women were randomized to a caloric-restriction diet (goal: 10% weight-loss), aerobic-exercise (225 min/week moderate-to-vigorous activity), combined diet+exercise, or control. Dietary inflammatory index (DII) and energy-adjusted (E-DII) scores were derived from food frequency questionnaires (FFQ) and could be calculated for 365 participants with complete FFQs at baseline and 12 months. Changes from baseline to 12 months in E-DII scores in the intervention arms versus controls were analyzed using generalized estimating equations, adjusted for confounders. We examined associations between changes in previously measured biomarkers and E-DII at 12 months. Participants randomized to diet and diet+exercise arms had greater reductions in E-DII (-104.4% and -84.4%), versus controls (-34.8%, both  P  < 0.001). Weight change had a more marked effect than E-DII change on biomarkers at 12-months; associations between E-DII and biomarker changes were reduced after adjustment by weight change. Changes in E-DII at 12 months, adjusted for weight change, were negatively associated with changes in ghrelin [ r  = -0.19;  P  = 0.05 (diet),  r  = -0.29;  P  = 0.02 (diet+exercise)], and positively with VEGF [ r  = 0.22;  P  = 0.03 (diet+exercise)], and red blood cell counts [ r  = 0.30;  P  = 0.004 (exercise)]. C-reactive protein (CRP) and IL6 levels were not associated with E-DII changes at 12 months. In conclusion, a behavior change of low-calorie, low-fat diet significantly reduces dietary inflammatory potential, modulating biomarkers that are associated with tumorigenesis, such as VEGF, but not CRP or IL6.",2020,C-reactive protein (CRP) and Interleukin (IL)-6 levels were not associated with E-DII changes at 12-months.,"['Women', '365 participants with complete FFQs at baseline and 12-months', '438 overweight/obese, healthy, postmenopausal women']","['diet and diet+exercise', 'caloric-restriction diet (goal: 10% weight-loss), aerobic-exercise (225 min/week moderate-to-vigorous activity), combined diet+exercise, or control']","['C-reactive protein (CRP) and Interleukin (IL)-6 levels', 'E-DII ', 'vascular endothelial growth factor', 'E-DII scores', 'Dietary inflammatory index (DII®) and energy-adjusted (E-DIITM) scores', 'red blood cell counts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",438.0,0.0711963,C-reactive protein (CRP) and Interleukin (IL)-6 levels were not associated with E-DII changes at 12-months.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. cduggan@fhcrc.org.'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Tapsoba', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Harris', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Ching-Yun', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McTiernan', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0181']
2551,32857151,Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial.,"Importance


Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking.
Objective


To determine the effectiveness of a short-term integrated palliative care (SIPC) intervention for people with LTNCs.
Design, Setting, and Participants


Multicenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services. A total of 535 patients with LTNC were assessed for eligibility and 350 were randomized. Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy. Data were analyzed from November 2018 to March 2019.
Interventions


Patients were randomized 1:1 using minimization method to receive SIPC (intervention, n = 176) or standard care (control, n = 174).
Main Outcomes and Measures


Primary outcome was change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions. Secondary outcomes included change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs. Data were collected and analyzed blindly by intention to treat.
Results


A total of 350 patients (mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n = 229). There were no between-group differences in primary outcome (effect size, -0.16; 95% CI, -0.37 to 0.05), any other patient-reported outcomes, adverse events, or survival. Although there was more symptom reduction in the SIPC group in relation to mean change in primary outcome, the difference between the groups was not statistically significant (-0.78; 95% CI, -1.29 to -0.26 vs -0.28; 95% CI, -0.82 to 0.26; P = .14). There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367 (95% CI, -$2450 to -$282) in the SIPC group and -653 (95% CI, -$1839 to -$532) in the control group, but this difference was not statistically significant (P = .12). SIPC was perceived by patients and caregivers as building resilience, attending to function and deficits, and enabling caregivers.
Conclusions and Relevance


In this study, SIPC was not statistically significantly different from standard care for the patient-reported outcomes. However, SIPC was associated with lower cost, and in qualitative analysis was well-received by patients and caregivers, and there were no safety concerns. Further research is warranted.
Trial Registration


isrctn.org Identifier: ISRCTN18337380.",2020,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"['Participants\n\n\nMulticenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services', 'Patients Severely Affected With Long-term Neurological Conditions', 'patients with long-term neurological conditions (LTNCs', '535 patients with LTNC were assessed for eligibility and 350 were randomized', 'patients with advanced cancer', 'people with LTNCs', 'Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy', 'mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n\u2009=\u2009229', '350 patients']","['SIPC (intervention, n\u2009=\u2009176) or standard care (control, n\u2009=\u2009174', 'Short-term Integrated Palliative Care', 'short-term integrated palliative care (SIPC) intervention']","['change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs', 'change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions', 'mean health and social care costs', 'symptom intensity and quality of life', 'symptom reduction', 'adverse events, or survival']","[{'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517604', 'cui_str': '174'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",535.0,0.243461,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Hepgul', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Department of Palliative Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lindsay', 'Affiliation': 'Marlets Hospice, Hove, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'The Walton Centre NHS Foundation Trust and University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Groves', 'Affiliation': 'Queenscourt Hospice, Southport, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': ""Department of Palliative Care, Ashford and St Peter's Hospitals NHS Foundation Trust, Surrey, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burman', 'Affiliation': ""Department of Palliative Care, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'K Ray', 'Initials': 'KR', 'LastName': 'Chaudhuri', 'Affiliation': 'Parkinson Foundation International Centre of Excellence, Kings College Hospital and Kings College London, London, United Kingdom.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Silber', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Trust, London, United Kingdom.""}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.15061']
2552,32860991,Automated MRI assessment confirms cartilage thickness modification in patients with knee osteoarthritis: post-hoc analysis from a phase II sprifermin study.,"BACKGROUND


Sprifermin is under investigation as a potential disease-modifying osteoarthritis drug. Previously, 2-year results from the FORWARD study showed significant dose-dependent modification of cartilage thickness in the total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions, by quantitative magnetic resonance imaging (qMRI) using manual segmentation.
OBJECTIVE


To determine whether qMRI findings from FORWARD could be reproduced by an independent method of automated segmentation using an identical dataset and similar anatomical regions in a post-hoc analysis.
METHOD


Cartilage thickness was assessed at baseline and 6, 12, 18 and 24 months, using automated cartilage segmentation with active appearance models, a supervised machine learning method. Images were blinded for treatment and timepoint. Treatment effect was assessed by observed and adjusted changes using a linear mixed model for repeated measures.
RESULTS


Based on automated segmentation, statistically significant, dose-dependent structural modification of cartilage thickness was observed over 2 years with sprifermin vs placebo for TFTJ (overall treatment effect and dose response, both P < 0.001), MFTC (P = 0.004 and P = 0.044), and LFTC (both P < 0.001) regions. For highest dose, in the central medial tibial (P = 0.008), central lateral tibial (P < 0.001) and central lateral femoral (P < 0.001) regions.
CONCLUSIONS


Cartilage thickness assessed by automated segmentation provided a consistent dose response in structural modification compared with manual segmentation. This is the first time that two independent quantification methods of image analysis have reached the same conclusions in an interventional trial, strengthening the conclusions that sprifermin modifies structural progression in knee osteoarthritis.",2020,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
",['patients with knee osteoarthritis'],"['placebo', 'MRI assessment']","['structural modification of cartilage thickness', 'total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions', 'cartilage thickness', 'central lateral tibial (P<0.001) and central lateral femoral', 'MFTC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0581602', 'cui_str': 'Structural modification'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.166877,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: Alan.Brett@stryker.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: mike.bowes@stryker.com.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK. Electronic address: p.conaghan@leeds.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: christoph.ladel@merckgroup.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: hans.guehring@merckgroup.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono, Billerica, MA, USA. Electronic address: flavie.moreau@emdserono.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.08.005']
2553,32865577,Effect of Telehealth Treatment by Lay Counselors vs by Clinicians on Depressive Symptoms Among Older Adults Who Are Homebound: A Randomized Clinical Trial.,"Importance


Older adults who are homebound and have low income have limited access to psychosocial treatments because of their homebound state and geriatric mental health workforce shortages.
Objective


To evaluate clinical effectiveness of a brief, aging service-integrated, videoconferenced behavioral activation (tele-BA) treatment delivered by lay counselors compared with videoconferenced problem-solving therapy (tele-PST) delivered by licensed clinicians and attention control (AC; telephone support calls).
Design, Setting, and Participants


This 3-group randomized clinical trial using a randomization prior to consent approach included individuals aged 50 years or older who were homebound and had 24-item Hamilton Depression Rating Scale (HAMD) scores of 15 or greater between February 15, 2016, and April 15, 2019. Tele-BA and tele-PST participants received 5 weekly treatment sessions. Assessments were performed at baseline and 12, 24, and 36 weeks after baseline. Intention-to-treat statistical analyses were performed from January 1, 2020, to February 15, 2020.
Interventions


Tele-BA participants were taught 5 steps for reinforcing healthy behaviors to improve mood, physical functioning, and social engagement. Tele-PST participants were taught a 7-step approach for problem solving coping skills.
Main Outcomes and Measures


The primary outcome was the 24-item HAMD scores. Response (ie, ≥50% reduction in HAMD) and remission (ie, HAMD <10) rates and effect sizes for clinically meaningful differences were examined. Secondary outcomes were disability, social engagement and activity frequency, and satisfaction with participation in social roles.
Results


A total of 277 participants were enrolled, including 193 (69.7%) women, 83 (30.0%) who were Black, 81 (29.2%) who were Hispanic, and 255 (92.1%) with income of $35 000 or less. The mean (SD) age was 67.5 (8.9) years. Among these, 90 participants were randomized to tele-BA, 93 participants were randomized to tele-PST, and 94 participants were randomized to the AC. Compared with participants in the AC group, participants in the tele-BA and tele-PST groups had significantly higher response and remission rates and medium to large effect sizes (tele-BA: raw growth modeling analysis d = 0.62 [95% CI, 0.35 to 0.89]; P < .001; tele-PST: raw growth modeling analysis d = 1.00 [95% CI, 0.73 to 1.26]; P < .001) for HAMD scores. While tele-PST was significantly more effective than tele-BA for reducing HAMD scores (t258 = -2.79; P = .006), there was no difference between tele-BA and tele-PST on secondary outcomes.
Conclusions and Relevance


In this randomized clinical trial, participants who received tele-BA by lay counselors achieved statistically and clinically meaningful changes in depressive symptoms. Given shortages of licensed mental health clinicians, tele- and lay counselor-delivered services may help improve access to evidence-based depression treatment for large numbers of underserved older adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT02600754.",2020,"While tele-PST was significantly more effective than tele-BA for reducing HAMD scores (t258 = -2.79; P = .006), there was no difference between tele-BA and tele-PST on secondary outcomes.
","['90 participants were randomized to tele-BA, 93 participants were randomized to tele-PST, and 94 participants', 'Older Adults', 'individuals aged 50 years or older who were homebound and had 24-item Hamilton Depression Rating Scale (HAMD) scores of 15 or greater between February 15, 2016, and April 15, 2019', 'Older adults who are homebound and have low income', '277 participants were enrolled, including 193 (69.7%) women, 83 (30.0%) who were Black, 81 (29.2%) who were Hispanic, and 255 (92.1%) with income of $35\u202f000 or less', 'Who Are Homebound']","['Telehealth Treatment by Lay Counselors', 'videoconferenced problem-solving therapy (tele-PST', 'aging service-integrated, videoconferenced behavioral activation (tele-BA', 'tele-BA']","['response and remission rates and medium to large effect sizes', 'disability, social engagement and activity frequency, and satisfaction with participation in social roles', '24-item HAMD scores', 'HAMD scores', 'HAMD) and remission (ie, HAMD <10) rates and effect sizes', 'Depressive Symptoms', 'depressive symptoms']","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",277.0,0.173287,"While tele-PST was significantly more effective than tele-BA for reducing HAMD scores (t258 = -2.79; P = .006), there was no difference between tele-BA and tele-PST on secondary outcomes.
","[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Wilson', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Guoqing John', 'Initials': 'GJ', 'LastName': 'Chen', 'Affiliation': 'Center for Medical Informatics and Enterprise Analytics, University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Sirrianni', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15648']
2554,32865608,Introducing multiple-choice questions to promote learning for medical students: effect on exam performance in obstetrics and gynecology.,"PURPOSE


Testing is required in medical education. The large number of exams that students face requires effective learning strategies. Various methods of improving knowledge retention and recall have been discussed, two of the most widely evaluated of which are test-enhanced learning and pause procedures. This study investigated the effect of voluntary multiple-choice questions on students' performance.
METHODS


In a prospective study from April 2013 to March 2015, 721 students were randomly assigned to receive supplementary online material only (control group) or additional multiple-choice questions (investigative group) accompanying lectures. Their performance in the final exam was evaluated.
RESULTS


A total of 675 students were ultimately included, with 299 randomly assigned to the investigative group and 376 to the control group. Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05). The effect declined over time.
CONCLUSION


This is the first study of the use of voluntary multiple-choice questions to improve medical students' performance. The results support test-enhanced learning and the feasibility of implementing multiple-choice questions in lectures.",2020,Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05).,"['April 2013 to March 2015, 721 students', ""students' performance"", 'A total of 675 students were ultimately included, with 299 randomly assigned to the investigative group and 376 to the control group', 'medical students']","['supplementary online material only (control group) or additional multiple-choice questions (investigative group) accompanying lectures', 'voluntary multiple-choice questions']",[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",[],675.0,0.0204113,Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05).,"[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Jud', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany. sebastian.jud@uk-erlangen.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cupisti', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Frobenius', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schultheis', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Heindl', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05758-1']
2555,32860406,The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial.,"AIMS 


Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent.
METHODS AND RESULTS 


Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group.
CONCLUSIONS 


Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.",2020,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"['acute myocardial infarction', 'patients following acute myocardial infarction (AMI', '375 patients were recruited: 185 patients', 'patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI']","['Bone marrow-derived mononuclear cell', 'treatment arm (intracoronary infusion of BM-MNCs 2-8\u2009days after PPCI', 'intracoronary infusion of bone marrow-derived mononuclear cells', 'BM-MNC) therapy']","['adverse events nor serious adverse events', 'hospitalized for stroke', 'myocardial recovery', 'heart failure']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",375.0,0.0908235,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital Aalst, Aalst, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU, Leuven, Leuven, Belgium.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Sheik', 'Initials': 'S', 'LastName': 'Dowlut', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Galiñanes', 'Affiliation': ""Department of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Good', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hauskeller', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'University Hospitals (UZ) Leuven, Belgium.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshospitalet and University of Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Menasché', 'Affiliation': 'Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Ylä-Herttuala', 'Affiliation': 'University of Eastern Finland, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa651']
2556,32865374,Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation.,"BACKGROUND


Implementation of appropriate oral anticoagulant treatment for the prevention of stroke in very elderly patients with atrial fibrillation is challenging because of concerns regarding bleeding.
METHODS


We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven trial to compare a once-daily 15-mg dose of edoxaban with placebo in elderly Japanese patients (≥80 years of age) with nonvalvular atrial fibrillation who were not considered to be appropriate candidates for oral anticoagulant therapy at doses approved for stroke prevention. The primary efficacy end point was the composite of stroke or systemic embolism, and the primary safety end point was major bleeding according to the definition of the International Society on Thrombosis and Haemostasis.
RESULTS


A total of 984 patients were randomly assigned in a 1:1 ratio to receive a daily dose of 15 mg of edoxaban (492 patients) or placebo (492 patients). A total of 681 patients completed the trial, and 303 discontinued (158 withdrew, 135 died, and 10 had other reasons); the numbers of patients who discontinued the trial were similar in the two groups. The annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group (hazard ratio, 0.34; 95% confidence interval [CI], 0.19 to 0.61; P<0.001), and the annualized rate of major bleeding was 3.3% in the edoxaban group and 1.8% in the placebo group (hazard ratio, 1.87; 95% CI, 0.90 to 3.89; P = 0.09). There were substantially more events of gastrointestinal bleeding in the edoxaban group than in the placebo group. There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
CONCLUSIONS


In very elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for standard doses of oral anticoagulants, a once-daily 15-mg dose of edoxaban was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding than placebo. (Funded by Daiichi Sankyo; ELDERCARE-AF ClinicalTrials.gov number, NCT02801669.).",2020,"There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
","['elderly Japanese patients (≥80 years of age) with nonvalvular atrial fibrillation who were not considered to be appropriate candidates for oral anticoagulant therapy at doses approved for stroke prevention', '681 patients completed the trial, and 303 discontinued (158 withdrew, 135 died, and 10 had other reasons); the numbers of patients who discontinued the trial were similar in the two groups', 'elderly patients with atrial fibrillation', 'elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for standard doses of', 'A total of 984 patients', 'Very Elderly Patients with Atrial Fibrillation']","['oral anticoagulants', 'edoxaban', 'placebo', 'edoxaban with placebo', 'Low-Dose Edoxaban']","['stroke or systemic embolism', 'gastrointestinal bleeding', 'death', 'annualized rate of stroke or systemic embolism', 'composite of stroke or systemic embolism, and the primary safety end point was major bleeding according to the definition of the International Society on Thrombosis and Haemostasis', 'major bleeding', 'annualized rate of major bleeding']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",984.0,0.67237,"There was no substantial between-group difference in death from any cause (9.9% in the edoxaban group and 10.2% in the placebo group; hazard ratio, 0.97; 95% CI, 0.69 to 1.36).
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kawata', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Okazaki', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Akashi', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Eshima', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Tanizawa', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Fukuzawa', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Akishita', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'From the Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto (K.O.), the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M. Akao), Onga Nakama Medical Association Onga Hospital, Onga (T. Yoshida), the Department of Cardiology, Akashi Medical Center, Akashi (M.K.), the Department of Cardiology, National Center for Global Health and Medicine (O.O.), Clinical Development Department III, Development Function, Research and Development Division (K.T., M.F.), and the Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo, the Department of Geriatric Medicine, Graduate School of Medicine, University of Tokyo (M. Akishita), and the Cardiovascular Institute (T. Yamashita), Tokyo, the Division of Cardiology, Hamada Medical Center, Hamada (S.A.), and the Department of Cardiology, Saga-Ken Medical Center Koseikan, Saga (K.E.) - all in Japan; the Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (G.Y.H.L.); and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark (G.Y.H.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2012883']
2557,32863509,Childhood Protective Factors and a Prevention Program Reduce Later Problem Behaviors.,"Prior research has yet to elucidate how constellations of protective factors in childhood and prevention efforts simultaneously may influence youth involvement in problem behaviors across different points in development. The current study examines how latent classes of social and emotional learning (SEL) skills, parent-child relationships, and peer influences in third grade and receipt of an ongoing SEL intervention predict substance use and violence in fifth and eighth grade. The urban, predominantly low-income, sample ( N  = 1,169) was nested in 14 schools that were randomly assigned to the  Positive Action  program or business-as-usual. Membership in a latent class reflecting protective childhood factors predicted less substance use and violence in fifth grade; however, the SEL program predicted less substance use and violence in eighth grade. Findings generally support that SEL interventions can successfully target and boost developmentally appropriate positive behaviors and can prevail over initial risk factors with enough time and exposure.",2019,Findings generally support that SEL interventions can successfully target and boost developmentally appropriate positive behaviors and can prevail over initial risk factors with enough time and exposure.,"['The urban, predominantly low-income, sample ( N  = 1,169) was nested in 14 schools']",['Positive Action  program or business-as-usual'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085936', 'cui_str': 'Business'}]",[],,0.0290893,Findings generally support that SEL interventions can successfully target and boost developmentally appropriate positive behaviors and can prevail over initial risk factors with enough time and exposure.,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Duncan', 'Affiliation': 'Purdue University.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Rolan', 'Affiliation': 'Purdue University.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Marceau', 'Affiliation': 'Purdue University.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Lewis', 'Affiliation': 'University of California, Agriculture and Natural Resources.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Bavarian', 'Affiliation': 'California State University, Long Beach.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DuBois', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flay', 'Affiliation': 'Oregon State University.'}]",Journal of applied developmental psychology,['10.1016/j.appdev.2019.101063']
2558,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2021,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
2559,32865557,Representation of Women in Cardiovascular Clinical Trial Leadership.,,2020,,[],[],[],[],[],[],,0.147298,,"[{'ForeName': 'Kara J', 'Initials': 'KJ', 'LastName': 'Denby', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Szpakowski', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Silver', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Mary Norine', 'Initials': 'MN', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology, St Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2485']
2560,32865576,Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial.,"Importance


Eating disorders (EDs) are common, serious psychiatric disorders on college campuses, yet most affected individuals do not receive treatment. Digital interventions have the potential to bridge this gap.
Objective


To determine whether a coached, digital, cognitive behavior therapy (CBT) intervention improves outcomes for college women with EDs compared with referral to usual care.
Design, Setting, and Participants


This cluster randomized trial was conducted from 2014 to 2018 at 27 US universities. Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities. The 690 participants were followed up for up to 2 years after the intervention. Data analysis was performed from February to September 2019.
Interventions


Universities were randomized to the intervention, Student Bodies-Eating Disorders, a digital CBT-guided self-help program, or to referral to usual care.
Main Outcomes and Measures


The main outcome was change in overall ED psychopathology. Secondary outcomes were abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access.
Results


A total of 690 women with EDs (mean [SD] age, 22.12 [4.85] years; 414 [60.0%] White; 120 [17.4%] Hispanic; 512 [74.2%] undergraduates) were included in the analyses. For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10]; d = -0.40; t1387 = -4.23; P < .001), as well as over the follow-up period (β [SE], -0.39 [0.12]; d = -0.35; t1387 = -3.30; P < .001). There was not a significant difference in abstinence from any ED behaviors at the postintervention assessment (odds ratio, 1.48; 95% CI, 0.48-4.62; P = .50) or at follow-up (odds ratio, 1.51; 95% CI, 0.63-3.58; P = .36). Compared with the control group, the intervention group had significantly greater reductions in binge eating (rate ratio, 0.82; 95% CI, 0.70-0.96; P = .02), compensatory behaviors (rate ratio, 0.68; 95% CI, 0.54-0.86; P < .001), depression (β [SE], -1.34 [0.53]; d = -0.22; t1387 = -2.52; P = .01), and clinical impairment (β [SE], -2.33 [0.94]; d = -0.21; t1387 = -2.49; P = .01) at the postintervention assessment, with these gains sustained through follow-up for all outcomes except binge eating. Groups did not differ in terms of academic impairment. The majority of intervention participants (318 of 385 participants [83%]) began the intervention, whereas only 28% of control participants (76 of 271 participants with follow-up data available) sought treatment for their ED (odds ratio, 12.36; 95% CI, 8.73-17.51; P < .001).
Conclusions and Relevance


In this cluster randomized clinical trial comparing a coached, digital CBT intervention with referral to usual care, the intervention was effective in reducing ED psychopathology, compensatory behaviors, depression, and clinical impairment through long-term follow-up, as well as realizing treatment access. No difference was found between the intervention and control groups for abstinence for all ED behaviors or academic impairment. Given its scalability, a coached, digital, CBT intervention for college women with EDs has the potential to address the wide treatment gap for these disorders.
Trial Registration


ClinicalTrials.gov Identifier: NCT02076464.",2020,"For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10];","['Eating Disorders in College Women', '690 participants were followed up for up to 2 years after the intervention', '690 women with EDs (mean [SD] age', 'Hispanic; 512 [74.2%] undergraduates) were included in the analyses', 'Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities', 'college women with EDs compared with referral to usual care', '2014 to 2018 at 27 US universities', 'college women with EDs']","['digital CBT intervention', 'digital CBT-guided self-help program, or to referral to usual care', 'Digital Cognitive Behavior Therapy-Guided Self-Help Intervention', 'coached, digital, cognitive behavior therapy (CBT) intervention']","['abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access', 'binge eating', 'academic impairment', 'overall ED psychopathology', 'compensatory behaviors', 'abstinence from any ED behaviors', 'ED psychopathology, compensatory behaviors, depression, and clinical impairment']","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0855227', 'cui_str': 'Purging'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",690.0,0.142186,"For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10];","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sadeh-Sharvit', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, San Diego.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Monterubio', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Goel', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Rachael E', 'Initials': 'RE', 'LastName': 'Flatt', 'Affiliation': 'Department of Psychology and Neurosciences, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Karam', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mickey T', 'Initials': 'MT', 'LastName': 'Trockel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15633']
2561,32858977,The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study.,"Spinal cord stimulation may enable recovery of volitional motor control in people with chronic Spinal Cord Injury (SCI). In this study we explored the effects of adding SCS, applied transcutaneously (tSCS) at vertebral levels T10/11, to a sit-to-stand training intervention in people with motor complete and incomplete SCI. Nine people with chronic SCI (six motor complete; three motor incomplete) participated in an 8-week intervention, incorporating three training sessions per week. Participants received either tSCS combined with sit-to-stand training (STIM) or sit-to-stand training alone (NON-STIM). Outcome measures were carried out before and after the intervention. Seven participants completed the intervention (STIM N = 5; NON-STIM N = 2). Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants. Recovery of volitional lower limb muscle activity and/or movement (with tSCS off) was noted in three STIM participants. Unassisted standing was not achieved in any participant, although standing with minimal assistance was achieved in one STIM participant. This pilot study has shown that the recruitment of participants, intervention and outcome measures were all feasible in this study design. However, some modifications are recommended for a larger trial.",2020,"Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants.","['people with chronic Spinal Cord Injury (SCI', 'Nine people with chronic SCI (six motor complete; three motor incomplete', 'people with motor complete and incomplete SCI', 'People with Spinal Cord Injury']","['Spinal cord stimulation', 'SCS, applied transcutaneously (tSCS', 'tSCS combined with sit-to-stand training (STIM) or sit-to-stand training alone (NON-STIM', 'Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training']","['Unassisted standing', 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",9.0,0.0995996,"Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants.","[{'ForeName': 'Yazi', 'Initials': 'Y', 'LastName': ""Al'joboori"", 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Massey', 'Affiliation': 'Aspire CREATe, UCL, Stanmore HA7 4LP, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Knight', 'Affiliation': 'London Spinal Cord Injury Centre, Royal National Orthopaedic Hospital, Stanmore HA7 4LP, UK.'}, {'ForeName': 'Nick de N', 'Initials': 'NN', 'LastName': 'Donaldson', 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}, {'ForeName': 'Lynsey D', 'Initials': 'LD', 'LastName': 'Duffell', 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}]",Journal of clinical medicine,['10.3390/jcm9092765']
2562,32868016,Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.,"PURPOSE


To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).
MATERIALS AND METHODS


A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]).
RESULTS


In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes.
CONCLUSIONS


In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.",2020,Primary patency was 65.4% in women and 71.8% in men (P = .302).,"['Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long', 'Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P\xa0= .063', 'women compared with men', 'patients with peripheral artery disease (PAD) treated with', 'Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial']","['DCB', 'PTA', 'IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA']","['36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR', 'safety and mortality outcomes', 'TLR', 'Mean reference vessel diameter (RVD', 'Mean RVD', 'Primary patency']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",,0.152347,Primary patency was 65.4% in women and 71.8% in men (P = .302).,"[{'ForeName': 'Maureen P', 'Initials': 'MP', 'LastName': 'Kohi', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco, 505 Parnassus Avenue, M-361, San Francisco, CA 94143. Electronic address: Maureen.Kohi@ucsf.edu.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Medical University, Graz, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Angiology Department, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Micari', 'Affiliation': 'Cardiology Department, Humanitas Gavazzeni Hospital, Bergamo, Italy.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Division of Angiology, University Hospital of Bern Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Aortic, Peripheral and Venous Department, Medtronic, Santa Rosa, California.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Wall', 'Affiliation': 'Aortic, Peripheral and Venous Department, Medtronic, Plymouth, Minnesota.'}, {'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': 'St. Joseph Heart and Vascular Center, Orange, California.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.05.012']
2563,32862830,Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial.,"BACKGROUND


Intestinal microbiota restoration can be achieved by complementing a subject's perturbed microbiota with that of a healthy donor. Recurrent Clostridioides difficile infection (rCDI) is one key application of such treatment. Another emerging application of interest is reducing antibiotic-resistant genes (ARGs) and organisms (AROs). In this study, we investigated fecal specimens from a multicenter, randomized, double-blind, placebo-controlled phase 2b study of microbiota-based investigational drug RBX2660. Patients were administered either placebo, 1 dose of RBX2660 and 1 placebo, or 2 doses of RBX2660 via enema and longitudinally tracked for changes in their microbiome and antibiotic resistome.
RESULTS


All patients exhibited significant recovery of gut microbiome diversity and a decrease of ARG relative abundance during the first 7 days post-treatment. However, the microbiome and resistome shifts toward average configurations from unperturbed individuals were more significant and longer-lasting in RBX2660 recipients compared to placebo. We quantified microbiome and resistome modification by RBX2660 using a novel ""transplantation index"" metric. We identified taxonomic and metabolic features distinguishing the baseline microbiome of non-transplanted patients and taxa specifically enriched during the process of transplantation. We elucidated the correlation between resistome and taxonomic transplantations and post-treatment dynamics of patient-specific and RBX2660-specific ARGs. Whole genome sequencing of AROs cultured from RBX2660 product and patient samples indicate ARO eradication in patients via RBX2660 administration, but also, to a lesser extent, introduction of RBX2660-derived AROs.
CONCLUSIONS


Through shotgun metagenomic sequencing, we elucidated the effects of RBX2660 in the microbiome and resistome. Antibiotic discontinuation alone resulted in significant recovery of gut microbial diversity and reduced ARG relative abundance, but RBX2660 administration more rapidly and completely changed the composition of patients' microbiome, resistome, and ARO colonization by transplanting RBX2660 microbiota into the recipients. Although ARGs and AROs were transmitted through RBX2660, the resistome post-RBX2660 more closely resembled that of the administered product-a proxy for the donor-than an antibiotic perturbed state.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02299570 . Registered 19 November 2014 Video Abstract.",2020,"Antibiotic discontinuation alone resulted in significant recovery of gut microbial diversity and reduced ARG relative abundance, but RBX2660 administration more rapidly and completely changed the composition of patients' microbiome, resistome, and ARO colonization by transplanting RBX2660 microbiota into the recipients.",[],"['RBX2660 and 1 placebo, or 2 doses of RBX2660', 'investigational microbiota therapeutic RBX2660', 'placebo']","['ARG relative abundance', 'gut microbial diversity and reduced ARG relative abundance', 'gut microbiome diversity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.26577,"Antibiotic discontinuation alone resulted in significant recovery of gut microbial diversity and reduced ARG relative abundance, but RBX2660 administration more rapidly and completely changed the composition of patients' microbiome, resistome, and ARO colonization by transplanting RBX2660 microbiota into the recipients.","[{'ForeName': 'Suryang', 'Initials': 'S', 'LastName': 'Kwak', 'Affiliation': 'The Edison Family Center for Genome Sciences & Systems Biology, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'JooHee', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'The Edison Family Center for Genome Sciences & Systems Biology, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Hink', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Reske', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Blount', 'Affiliation': 'Rebiotix Inc. a Ferring Company, Minneapolis, MN, 55113, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Rebiotix Inc. a Ferring Company, Minneapolis, MN, 55113, USA.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Bost', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The Edison Family Center for Genome Sciences & Systems Biology, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Carey-Ann D', 'Initials': 'CD', 'LastName': 'Burnham', 'Affiliation': 'Department of Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Dubberke', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA. edubberk@wustl.edu.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'The Edison Family Center for Genome Sciences & Systems Biology, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA. dantas@wustl.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Microbiome,['10.1186/s40168-020-00907-9']
2564,32868354,Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect.,"INTRODUCTION


Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.
METHODS AND ANALYSIS


This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.
ETHICS AND DISSEMINATION


This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
TRIAL REGISTRATION NUMBER


NCT03288246.",2020,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","['Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes', 'adolescents and youth living with HIV in Haiti', '150 participants ages 10-24 who have been on ART for >6 months']","['POC VL testing', 'POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling', 'standard laboratory-based VL testing', 'laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1\u2009month later, at which time they receive ART adherence counselling']",['VL suppression'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",150.0,0.15321,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","[{'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Reif', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA lir2020@med.cornell.edu.'}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Severe', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Joseph Marie', 'Initials': 'JM', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Apollon', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Elul', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036147']
2565,32865079,Participant Satisfaction with Computer-Delivered Intervention Components and Its Relation to Alcohol Outcomes.,"BACKGROUND


Few computer-delivered brief intervention (CDBI) studies have evaluated participant satisfaction with individual elements of the intervention, or whether participant satisfaction impacts intervention outcomes.  Purpose:  This factorial trial examined whether subjective reactions to a CDBI for heavy drinking (1) varied depending on the presence versus absence of an animated narrator, a spoken voice, empathic reflections, and motivational interviewing (MI) strategies and (2) were associated with drinking outcomes at 3-month follow-up.  Methods:  Participants were 352 heavy drinking university students. All participants were randomly assigned to one of 16 versions of a CDBI. After finishing the CDBI, participants completed measures of intervention likability and perceived empathy. Alcohol use outcomes were assessed at 3-month follow-up.  Results:  CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy. However, higher likeability ratings were associated with decreases in alcohol use outcomes over the 3-month assessment period.  Conclusions:  Results indicate that subjective reactions to CDBIs can have important effects on alcohol use outcomes.",2020,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,['Participants were 352 heavy drinking university students'],[],"['intervention likability and perceived empathy', 'higher likeability ratings', 'participant ratings of likeability and perceived empathy']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0194355,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,"[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Fodor', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Grekin', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Beatty', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McGoron', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1811343']
2566,32867406,Training in statistical analysis reduces the framing effect among medical students and residents in Argentina.,"PURPOSE


The framing effect refers to a phenomenon wherein, when the same problem is presented using different representations of information, people make significant changes in their decisions. This study aimed to explore whether the framing effect could be reduced in medical students and residents by teaching them the statistical concepts of effect size, probability, and sampling for use in the medical decision-making process.
Methods


Ninety-five second-year medical students and 100 second-year medical residents of Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017. A questionnaire was developed to assess the different types of framing effects in medical situations. After an initial administration of the survey, students and residents were taught statistical concepts including effect size, probability, and sampling during 2 individual independent official biostatistics courses. After these interventions, the same questionnaire was randomly administered again, and pre- and post-intervention outcomes were compared among students and residents.
RESULTS


Almost every type of framing effect was reproduced either in the students or in the residents. After teaching medical students and residents the analytical process behind statistical concepts, a significant reduction in sample-size, risky-choice, pseudo-certainty, number-size, attribute, goal, and probabilistic formulation framing effects was observed.
Conclusion


The decision-making of medical students and residents in simulated medical situations may be affected by different frame descriptions, and these framing effects can be partially reduced by training individuals in probability analysis and statistical sampling methods.",2020,Almost every type of framing effect was reproduced either in the students or in the resident population.,"['Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017', 'Methods\n\n\nNinety-five second-year medical students and 100 second-year medical residentsof']",[],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],[],,0.0258185,Almost every type of framing effect was reproduced either in the students or in the resident population.,"[{'ForeName': 'Raúl Alfredo', 'Initials': 'RA', 'LastName': 'Borracci', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo Benigno', 'Initials': 'EB', 'LastName': 'Arribalzaga', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Thierer', 'Affiliation': 'School of Medicine, Buenos Aires University, Buenos Aires, Argentina.'}]",Journal of educational evaluation for health professions,['10.3352/jeehp.2020.17.25']
2567,32866432,"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).
METHODS


In this multicentre, open-label, phase 3, randomised controlled trial (the ENDURANCE trial; E1A11), we recruited patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT. Participants were recruited from 272 community oncology practices or academic medical centres in the USA. Key inclusion criteria were the absence of high-risk multiple myeloma and an Eastern Cooperative Oncology Group performance status of 0-2. Enrolled patients were randomly assigned (1:1) centrally by use of permuted blocks to receive induction therapy with either the VRd regimen or the KRd regimen for 36 weeks. Patients who completed induction therapy were then randomly assigned (1:1) a second time to either indefinite maintenance or 2 years of maintenance with lenalidomide. Randomisation was stratified by intent for ASCT at disease progression for the first randomisation and by the induction therapy received for the second randomisation. Allocation was not masked to investigators or patients. For 12 cycles of 3 weeks, patients in the VRd group received 1·3 mg/m 2  of bortezomib subcutaneously or intravenously on days 1, 4, 8, and 11 of cycles 1-8, and day 1 and day 8 of cycles nine to twelve, 25 mg of oral lenalidomide on days 1-14, and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. For nine cycles of 4 weeks, patients in the KRd group received 36 mg/m 2  of intravenous carfilzomib on days 1, 2, 8, 9, 15, and 16, 25 mg of oral lenalidomide on days 1-21, and 40 mg of oral dexamethasone on days 1, 8, 15, and 22. The coprimary endpoints were progression-free survival in the induction phase, and overall survival in the maintenance phase. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of their assigned treatment. The trial is registered with ClinicalTrials.gov, NCT01863550. Study recruitment is complete, and follow-up of the maintenance phase is ongoing.
FINDINGS


Between Dec 6, 2013, and Feb 6, 2019, 1087 patients were enrolled and randomly assigned to either the VRd regimen (n=542) or the KRd regimen (n=545). At a median follow-up of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival was 34·6 months (95% CI 28·8-37·8) in the KRd group and 34·4 months (30·1-not estimable) in the VRd group (hazard ratio [HR] 1·04, 95% CI 0·83-1·31; p=0·74). Median overall survival has not been reached in either group. The most common grade 3-4 treatment-related non-haematological adverse events included fatigue (34 [6%] of 527 patients in the VRd group vs 29 [6%] of 526 in the KRd group), hyperglycaemia (23 [4%] vs 34 [6%]), diarrhoea (23 [5%] vs 16 [3%]), peripheral neuropathy (44 [8%] vs four [<1%]), dyspnoea (nine [2%] vs 38 [7%]), and thromboembolic events (11 [2%] vs 26 [5%]). Treatment-related deaths occurred in two patients (<1%) in the VRd group (one cardiotoxicity and one secondary cancer) and 11 (2%) in the KRd group (four cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death).
INTERPRETATION


The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity. The VRd triplet regimen remains the standard of care for induction therapy for patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma, and is a suitable treatment backbone for the development of combinations of four drugs.
FUNDING


US National Institutes of Health, National Cancer Institute, and Amgen.",2020,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","['Patients who completed induction therapy', '1087 patients', 'Participants were recruited from 272 community oncology practices or academic medical centres in the USA', 'patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE', 'patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma', 'newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT', 'newly diagnosed multiple myeloma', 'patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT']","['lenalidomide and dexamethasone', 'KRd', 'lenalidomide and dexamethasone (KRd', 'bortezomib', 'oral dexamethasone', 'indefinite maintenance or 2 years of maintenance with lenalidomide', 'VRd regimen', 'KRd regimen', 'intravenous carfilzomib', 'Carfilzomib or bortezomib', 'induction therapy with either the VRd regimen or the KRd regimen', 'oral lenalidomide', 'Bortezomib, lenalidomide, and dexamethasone (VRd']","['thromboembolic events', 'cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death', 'diarrhoea', 'intention-to-treat population and safety', 'deaths', 'progression-free survival in the induction phase, and overall survival', 'progression-free survival', 'toxicity', 'dyspnoea', 'median progression-free survival', 'Median overall survival', 'peripheral neuropathy', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",1087.0,0.211992,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Jacobus', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare, Appleton, WI, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'MOHPA, Burnsville, MN, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Department of Hematology, Yale University, Hamden, CT, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Kaiser Permanente Lone Tree, Lone Tree, CO, USA.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Saint Francis Cancer Center, Greenville, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Parsons', 'Affiliation': 'Gundersen Health System, La Crosse, WI, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois Cancer Care, Peoria, IL, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Zonder', 'Affiliation': 'Department of Malignant Hematology, Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Faber', 'Affiliation': 'Oncology Hematology Care, Cincinnati, OH, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30452-6']
2568,32869230,Impact of mechanical simulator practice on clinical ERCP performance by novice surgical trainees: a randomized controlled trial.,"BACKGROUND


Lack of forward-viewing endoscopy experience impairs training in endoscopic retrograde cholangiopancreatography (ERCP). We evaluated the effect of ERCP mechanical simulator (EMS) practice on ERCP performance by surgical trainees.
PATIENTS AND METHODS


12 surgical trainees without endoscopy experience were randomly allocated to non-EMS (n = 6) programs or to EMS (n = 6) programs with coaching and 20 hours of supervised EMS practice. All trainees then received supervised hands-on clinical ERCP training. Trainers provided verbal instructions and hands-on assistance, and took over if cannulation was not achieved by 20 minutes. Blinded trainers rated clinical performance.
RESULTS


Each group performed 150 clinical ERCPs. Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001). EMS trainees showed a significantly better mean performance score ( P  = 0.006). In multivariate analysis, after adjusting for case sequence, CBD stone, complexity, and EMS training, the effect of EMS practice on odds for successful cannulation remained highly significant (odds ratio [OR] 2.10 [95 %CI 1.46 - 3.01]). At 6 months EMS trainees still had better cannulation success vs. non-EMS controls ( P  = 0.045); no difference was observed after 1 year.
CONCLUSIONS


EMS practice shortens the ERCP early learning curve of inexperienced surgical trainees, improves clinical success in selective biliary cannulation, and may reduce complications.",2020,"Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001).","['novice surgical trainees', '12 surgical trainees without endoscopy experience']","['supervised hands-on clinical ERCP training', 'mechanical simulator practice', 'non-EMS (n\u200a=\u200a6) programs or to EMS (n\u200a=\u200a6', 'ERCP mechanical simulator (EMS) practice']","['Biliary cannulation success', 'mean performance score', 'clinical ERCP performance', 'cannulation success', 'ERCP performance']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]",,0.1062,"Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001).","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Special Minimally Invasive Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yue', 'Affiliation': 'Department of Special Minimally Invasive Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Department of Gastroenterology, Sacramento VA Medical Center, Mather, California, United States.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Fangzhao', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhengfeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Wence', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}]",Endoscopy,['10.1055/a-1217-6727']
2569,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2  peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
2570,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2021,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
2571,32407638,Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial.,"Rationale:  Chronic bronchitis (CB) is characterized by productive cough with excessive mucus production, resulting in quality-of-life impairment and increased exacerbation risk. Bronchial rheoplasty uses an endobronchial catheter to apply nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium. Objectives:  To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB. Methods:  Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George's Respiratory Questionnaire (SGRQ). Measurements and Main Results:  Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV 1 , 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount ( P  < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, -7.9; median, -8.0;  P  = 0.0002) and SGRQ (mean, -14.6; median, -7.2;  P  = 0.0002) scores were observed, with similar observations through 12 months. Conclusions:  This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB.Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT03107494).",2020,"There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months.","['30 patients (63% male', 'symptomatic patients with CB.Clinical trial registered with', 'mean [SD] age, 67 [7.4', 'patients with CB', 'Chronic Bronchitis', '30 patients undergoing bilateral bronchial rheoplasty was conducted']",['www.anzctr.org.au'],"['COPD Assessment Test', 'SGRQ', ""adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George's Respiratory Questionnaire (SGRQ"", 'mean [SD] postbronchodilator', 'mean goblet cell hyperplasia score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0008677', 'cui_str': 'Chronic bronchitis'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0506994', 'cui_str': 'Goblet Cells'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.124149,"There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months.","[{'ForeName': 'Arschang', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fernandez-Bussy', 'Affiliation': 'Division of Pulmonary Medicine, German Clinic of Santiago, Chile.'}, {'ForeName': 'Alvin J', 'Initials': 'AJ', 'LastName': 'Ing', 'Affiliation': 'MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Steinfort', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Gregory I', 'Initials': 'GI', 'LastName': 'Snell', 'Affiliation': 'Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Williamson', 'Affiliation': 'MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tajalli', 'Initials': 'T', 'LastName': 'Saghaie', 'Affiliation': 'MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louis B', 'Initials': 'LB', 'LastName': 'Irving', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Eli J', 'Initials': 'EJ', 'LastName': 'Dabscheck', 'Affiliation': 'Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Krimsky', 'Affiliation': 'Medstar Franklin Square Medical Center, Baltimore, Maryland; and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Waldstreicher', 'Affiliation': 'Gala Therapeutics, Menlo Park, California.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1546OC']
2572,32872481,Twelve Weeks of Strengthening Exercise for Patients with Rheumatoid Arthritis: A Prospective Intervention Study.,"Rheumatoid arthritis (RA) patients may benefit from exercise for several reasons. However, whole-limb strengthening exercises for such patients remain poorly studied. We hypothesized that systemic strength training that includes the upper and lower extremities would improve strength per se and enhance the quality of life. Here, we investigated the effects of 12 weeks of upper- and lower-limb strengthening exercise on the strength and quality of life of RA patients using the International Classification of Functioning, Disability, and Health model. This was a prospective, interventional controlled trial. Forty female RA patients were recruited and assigned to two groups not based on willingness to exercise, with 20 patients in the exercise group and 20 in the control group. All patients in the exercise group received once-weekly training sessions of 60 min over 12 weeks. All participants were assessed before and after the 12-week intervention period. We measured the hand grip strength and isometric quadriceps contraction, the cross-sectional area of the rectus femoris (CSA-RF) (via ultrasonography), and performed the 30 s sit-to-stand test and the 6 min walk test (6MWT). We derived the Borg scale score after the 6MWT and assessed the extent of social participation and quality of life using a Korean version of the 36-Item Short Form Health Survey (SF-36). A total of 35 subjects completed the experiment (18 in the exercise group, 17 in the control group). After the 12-week intervention period, the lower-limb strength and the CSA-RF were significantly increased in the exercise group. The activity level did not change significantly in either group. The exercise group exhibited significant improvements in the SF-36 mental health domain scores. Thus, strengthening exercise is useful for patients with RA.",2020,"We measured the hand grip strength and isometric quadriceps contraction, the cross-sectional area of the rectus femoris (CSA-RF) (via ultrasonography), and performed the 30 s sit-to-stand test and the 6 min walk test (6MWT).","['Rheumatoid arthritis (RA) patients', 'Patients with Rheumatoid Arthritis', '35 subjects completed the experiment (18 in the exercise group, 17 in the control group', 'patients with RA', 'Forty female RA patients']","['upper- and lower-limb strengthening exercise', 'Strengthening Exercise', 'whole-limb strengthening exercises', 'strengthening exercise']","['lower-limb strength and the CSA-RF', 'strength and quality of life', 'social participation and quality of life using a Korean version of the 36-Item Short Form Health Survey (SF-36', 'activity level', 'SF-36 mental health domain scores', 'quality of life']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0275673,"We measured the hand grip strength and isometric quadriceps contraction, the cross-sectional area of the rectus femoris (CSA-RF) (via ultrasonography), and performed the 30 s sit-to-stand test and the 6 min walk test (6MWT).","[{'ForeName': 'Bomi', 'Initials': 'B', 'LastName': 'Sul', 'Affiliation': ""Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Kyoung Bo', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': ""Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Joo', 'Affiliation': ""Division of Rheumatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Hong', 'Affiliation': ""Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Joon-Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Ki-Jo', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': ""Division of Rheumatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Kyung-Su', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': ""Division of Rheumatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Yune-Jung', 'Initials': 'YJ', 'LastName': 'Park', 'Affiliation': ""Division of Rheumatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Lim', 'Affiliation': ""Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.""}]",Journal of clinical medicine,['10.3390/jcm9092792']
2573,32872249,Effects of Various Doses of Caffeine Ingestion on Intermittent Exercise Performance and Cognition.,"To date, no study has examined the effects of caffeine on prolonged intermittent exercise performance that imitates certain team-sports, and the suitable concentration of caffeine for improved intermittent exercise performance remains elusive. The purpose of the present cross-over, double-blind preliminary study was to investigate effects of low, moderate, and high doses of caffeine ingestion on intermittent exercise performance and cognition. Ten males performed a familiarization session and four experimental trials. Participants ingested capsules of placebo or caffeine (3, 6, or 9 mg/kg) at 1 h before exercise, rested quietly, and then performed cycling for 2 × 30 min. The cycling protocol consisted of maximal power pedaling for 5 s (mass × 0.075 kp) every minute, separated by unloaded pedaling for 25 s and rest for 30 s. At pre-ingestion of capsules, 1 h post-ingestion, and post-exercise, participants completed the Stroop task. The mean power-output (MPO), peak power-output (PPO), and response time (RT) in the Stroop task were measured. Only 3 mg/kg of caffeine had positive effects on the mean PPO and MPO; 3 mg/kg caffeine decreased RTs significantly in the incongruent and congruent conditions. These results indicate that the ingestion of low-dose caffeine had greater positive effects on the participants' physical strength during prolonged intermittent exercise and cognition than moderate- or high-dose caffeine.",2020,Only 3 mg/kg of caffeine had positive effects on the mean PPO and MPO; 3 mg/kg caffeine decreased RTs significantly in the incongruent and congruent conditions.,[],"['caffeine ingestion', 'caffeine', 'Caffeine Ingestion', 'placebo or caffeine']","['mean PPO and MPO', 'intermittent exercise performance and cognition', 'Intermittent Exercise Performance and Cognition', 'RTs', 'mean power-output (MPO), peak power-output (PPO), and response time (RT']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",10.0,0.0927196,Only 3 mg/kg of caffeine had positive effects on the mean PPO and MPO; 3 mg/kg caffeine decreased RTs significantly in the incongruent and congruent conditions.,"[{'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yuechuan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Zigui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10090595']
2574,32876697,Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.,"Importance


Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited.
Objective


To determine whether hydrocortisone improves outcome for patients with severe COVID-19.
Design, Setting, and Participants


An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020.
Interventions


The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108).
Main Outcomes and Measures


The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%).
Results


After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively.
Conclusions and Relevance


Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02735707.",2020,"The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone.","['Patients With Severe COVID-19', 'patients with severe COVID-19', 'Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries', '19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n\u2009=\u2009137), shock-dependent (n\u2009=\u2009146), and no (n\u2009=\u2009101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis']","['no hydrocortisone', 'hydrocortisone', 'Hydrocortisone', 'intravenous hydrocortisone']","['mechanical ventilation', 'mean body mass index', 'Mortality and Organ Support', 'posterior probability of an odds ratio greater', 'median adjusted odds ratio and bayesian probability of superiority', 'mortality rates', 'Serious adverse events', 'organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",614.0,0.46384,"The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Intensive Care Unit, Raymond Poincaré Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Beane', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'Bristol Royal Informatory, Bristol, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Clinical Studies and Center for Sepsis Control and Care (CSCC), Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Buxton', 'Affiliation': 'Global Coalition for Adaptive Research, San Francisco, California.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Buzgau', 'Affiliation': 'Helix, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam University Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Estcourt', 'Affiliation': 'NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Microbiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rashan', 'Initials': 'R', 'LastName': 'Haniffa', 'Affiliation': 'Network for Improving Critical Care Systems and Training, Colombo, Sri Lanka.'}, {'ForeName': 'Alisa M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Horvat', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'Hullegie', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Cardiac Intensive Care Unit, Peter Munk Cardiac Centre, University Health Network, Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Linstrum', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lorenzi', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothin', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McVerry', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'University of British Columbia School of Medicine, Vancouver, Canada.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Seymour', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van de Veerdonk', 'Affiliation': 'Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'Southside Clinical Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Medicine, Critical Care and Hematology/Medical Oncology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}]",JAMA,['10.1001/jama.2020.17022']
2575,32876689,Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial.,"Importance


Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option.
Objective


To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure.
Design, Setting, and Participants


Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board.
Interventions


Patients were randomized to receive low-dose hydrocortisone (n = 76) or placebo (n = 73).
Main Outcomes and Measures


The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay.
Results


The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment.
Conclusions and Relevance


In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death or persistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02517489.",2020,"The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29).","['group and 20 deaths in the placebo group', '149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled', 'critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure', 'France, with interim analyses planned every 50 patients', 'Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020', '290 patients but was stopped early following the recommendation of the data and safety monitoring board', 'Critically Ill Patients With COVID-19', 'critically ill patients with COVID-19 and acute respiratory failure, low-dose']","['low-dose hydrocortisone', 'Corticosteroids', 'placebo', 'hydrocortisone', 'Hydrocortisone']","['21-Day Mortality or Respiratory Support', 'death or persistent dependency on mechanical ventilation or high-flow oxygen therapy', 'treatment failure', 'treatment failure on day 21', 'need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0949757', 'cui_str': 'Data and Safety Monitoring Boards'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445105', 'cui_str': 'Not intubated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.710857,"The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29).","[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Raymond Poincaré (GHU APHP Université Paris Saclay), Garches, France, and RHU RECORDS and FHU SEPSIS.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Médecine Intensive Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Plantefève', 'Affiliation': 'Réanimation polyvalente, CH Victor Dupouy, Argenteuil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Voiriot', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Tenon (Assistance Publique-Hôpitaux de Paris), Paris, France.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Badié', 'Affiliation': 'Réanimation Polyvalente, Hôpital Nord Franche-Comté, Trevenans, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Réanimation Polyvalente, CHU de Limoges, Limoges, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Aubron', 'Affiliation': 'Médecine Intensive Réanimation, CHRU de Brest, Brest, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Université de Paris, IAME U1137, Médecine Intensive Réanimation, DMU ESPRIT, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris, Colombe, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Youenn', 'Initials': 'Y', 'LastName': 'Jouan', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guillon', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, CHU de Tours, Tours, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Coffre', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, CHU de Tours, Tours, France.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bourgoin', 'Affiliation': 'Pharmacie à Usage Interne, CHU de Tours, Tours, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lengellé', 'Affiliation': ""Centre régional de pharmacovigilance et d'information sur le médicament, service de pharmacosurveillance, CHU de Tours, Tours, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Caille-Fénérol', 'Affiliation': 'INSERM CIC 1435, CHU de Limoges, Limoges, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zohar', 'Affiliation': 'INSERM, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Raymond Poincaré (GHU APHP Université Paris Saclay), Garches, France, and RHU RECORDS and FHU SEPSIS.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16761']
2576,32876694,Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.,"Importance


Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support.
Objective


To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality.
Design, Setting, and Participants


Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios.
Exposures


Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients).
Main Outcomes and Measures


The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events.
Results


A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as ""low"" for 6 of the 7 mortality results and as ""some concerns"" in 1 trial because of the randomization method. Five trials reported mortality at 28 days, 1 trial at 21 days, and 1 trial at 30 days. There were 222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to usual care or placebo (summary OR, 0.66 [95% CI, 0.53-0.82]; P < .001 based on a fixed-effect meta-analysis). There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis. The fixed-effect summary OR for the association with mortality was 0.64 (95% CI, 0.50-0.82; P < .001) for dexamethasone compared with usual care or placebo (3 trials, 1282 patients, and 527 deaths), the OR was 0.69 (95% CI, 0.43-1.12; P = .13) for hydrocortisone (3 trials, 374 patients, and 94 deaths), and the OR was 0.91 (95% CI, 0.29-2.87; P = .87) for methylprednisolone (1 trial, 47 patients, and 26 deaths). Among the 6 trials that reported serious adverse events, 64 events occurred among 354 patients randomized to corticosteroids and 80 events occurred among 342 patients randomized to usual care or placebo.
Conclusions and Relevance


In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.",2020,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","['patients with coronavirus disease 2019 (COVID-19', 'hospitalized patients with COVID-19 who required respiratory support', '12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020', '1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis', 'critically ill patients with COVID-19, administration of systemic corticosteroids, compared with', '222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to', 'Critically Ill Patients With COVID-19', '1703 critically ill patients with COVID-19', '1025 patients']","['corticosteroids', 'systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo', 'methylprednisolone', 'usual care or placebo', 'dexamethasone', 'placebo', 'hydrocortisone']","['cause mortality', 'investigator-defined serious adverse events', 'mortality quantified using odds ratios (ORs', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3844105', 'cui_str': '425'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",1703.0,0.618646,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janet V', 'Initials': 'JV', 'LastName': 'Diaz', 'Affiliation': 'Clinical Unit, Health Emergencies Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Research Unit, Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Insitute, São Paulo, Brazil.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, INSERM CIC1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Faculty of Population Health Sciences, University College London, London, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, England.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Julian P T', 'Initials': 'JPT', 'LastName': 'Higgins', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine Department, Nottingham University Hospitals NHS Trust, Nottingham, England.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Anesthesiology, Pain, and Intensive Care Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Service de Médecine Intensive Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Savovic', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.17023']
2577,32873667,Randomised cross-over trial of vildagliptin and pioglitazone as add-on therapy in patients with type 2 diabetes: predicting Which One is Right Here (WORTH) study protocol.,"INTRODUCTION


There is emerging evidence for stratified glucose-lowering responses to certain oral medications for type 2 diabetes (T2D) by individual characteristics. The objective of this study was to test whether glycaemic response to representative treatments of dipeptidyl peptidase-4 inhibitors (vildagliptin) and thiazolidinediones (pioglitazone) varies according to ethnicity, gender, baseline obesity, triglyceride level or genetic variation.
METHODS


This is a multicentre, two-period, two-treatment, open-label, randomised cross-over trial of vildagliptin and pioglitazone as second-line or third-line therapy in patients with T2D who have suboptimal glycaemic control on metformin and/or sulfonylurea therapy. It is conducted in New Zealand with a target of 300 patients (40% with Māori or Pacific ancestry) eligible if aged ≥18 and ≤80 years, with T2D for more than 1 year, on stable doses of metformin and/or sulfonylurea for at least 3 months, with HbA1c between 59 and 110 mmol/mol inclusive. Participants are assigned to complete 4 months of vildagliptin 50 mg per day or pioglitazone 30 mg per day, followed by 4 months of the other medications in randomly allocated sequences. Participant characteristics, including ethnicity, obesity, lipid profile and candidate genotypes are collected at baseline. Primary outcome variable is on treatment HbA1c. Secondary outcomes include weight change, frequency of side effects and patient preference.
ETHICS AND DISSEMINATION


Ethical approval of the trial has been obtained from the New Zealand Health and Disability Ethics Committee (18/STH/242). The trial commenced in February 2019 and recruitment is expected to be completed by March 2020. Results will be reported in articles submitted to peer-reviewed journals, as well as in presentations at national and international meetings.
TRIAL REGISTRATION NUMBER


ACTRN12618001907235.",2020,"Secondary outcomes include weight change, frequency of side effects and patient preference.
","['patients with type 2 diabetes', '300 patients (40% with Māori or Pacific ancestry) eligible if aged ≥18 and ≤80 years, with T2D for more than 1 year, on stable doses of metformin and/or sulfonylurea for at least 3 months, with HbA1c between 59 and 110 mmol/mol inclusive', 'patients with T2D who have suboptimal glycaemic control on metformin and/or sulfonylurea therapy']","['vildagliptin 50 mg per day or pioglitazone', 'vildagliptin and pioglitazone', 'dipeptidyl peptidase-4 inhibitors (vildagliptin) and thiazolidinediones (pioglitazone']","['weight change, frequency of side effects and patient preference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",,0.196837,"Secondary outcomes include weight change, frequency of side effects and patient preference.
","[{'ForeName': 'Rui Qian', 'Initials': 'RQ', 'LastName': 'Yeu', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brandon', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Griffiths', 'Affiliation': 'Zoom Pharmacy, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Smallman', 'Affiliation': 'Diabetes Foundation Aotearoa, Auckland, New Zealand.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Moffitt', 'Affiliation': 'ProCARE Health Limited, Auckland, New Zealand.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Doherty', 'Affiliation': 'Tongan Health Society, Auckland, New Zealand.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Harré Hindmarsh', 'Affiliation': 'Ngati Porou Hauora, Te Puia Springs, Tairawhiti, New Zealand.'}, {'ForeName': 'Tony R', 'Initials': 'TR', 'LastName': 'Merriman', 'Affiliation': 'School of Medical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Macaskill-Smith', 'Affiliation': 'Ventures Limited, Hamilton, New Zealand.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Orr-Walker', 'Affiliation': 'Endocrinology and Diabetes Service, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand r.murphy@auckland.ac.nz.'}]",BMJ open,['10.1136/bmjopen-2019-036518']
2578,32873669,Effects of coenzyme Q10 on endothelial and cardiac function in patients undergoing haemodialysis: study protocol for a pilot randomised controlled trial.,"INTRODUCTION


Endothelial and cardiac dysfunction are highly prevalent and are associated with cardiovascular morbidity and mortality among patients undergoing dialysis. For patients undergoing dialysis, no study has explored the effect of supplementation of coenzyme Q10 (CoQ10) on endothelial function. To our best of knowledge, only two small sample studies focused on the efficacy of supplementation of CoQ10 on cardiac function. However, the effect of CoQ10 supplementation on cardiac function remains uncertain in patients who undergo haemodialysis. The aim of this study is to explore whether CoQ10 supplementation can improve endothelial and cardiac function in patients undergoing haemodialysis.
METHODS AND ANALYSIS


This is a pilot randomised controlled study. Eligible patients undergoing haemodialysis in our haemodialysis centre will be randomly allocated to the CoQ10 and control groups. The follow-up time is 12 months. The primary outcome is to assess the change of brachial artery endothelial-dependent flow-mediated dilation, left ventricular systolic function, diastolic function and Myocardial Performance Index at 12 months from baseline. Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
ETHICS AND DISSEMINATION


Risks associated with CoQ10 are minor, even at doses as high as 1800 mg according to previous studies. The trial has received ethics approval from the Medical Ethics Committee for Clinical Trials of Drugs, the 306th Hospital of Chinese PLA. The results of the study are expected to be published in a peer-reviewed journal and presented at academic conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900022258.",2020,"Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
","['patients undergoing haemodialysis', 'Eligible patients undergoing haemodialysis in our haemodialysis centre', 'patients who undergo haemodialysis', 'patients undergoing dialysis']","['coenzyme Q10', 'CoQ10 supplementation', 'CoQ10', 'coenzyme Q10 (CoQ10']","['death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index', 'endothelial and cardiac function', 'change of brachial artery endothelial-dependent flow-mediated dilation, left ventricular systolic function, diastolic function and Myocardial Performance Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",,0.153416,"Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
","[{'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Xinlou', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Medical Research, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Ultrasound in Medicine, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Ultrasound in Medicine, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Enhong', 'Initials': 'E', 'LastName': 'Han', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Fugui', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China gao306kidney@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-036732']
2579,32873496,The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic.,"OBJECTIVES


Social distancing under the COVID-19 pandemic has restricted access to community services for older adults with neurocognitive disorder (NCD) and their caregivers. Telehealth is a viable alternative to face-to-face service delivery. Telephone calls alone, however, may be insufficient. Here, we evaluated whether supplementary telehealth via video-conferencing platforms could bring additional benefits to care-recipient with NCD and their spousal caregivers at home.
PARTICIPANTS


Sixty older adults NCD-and-caregiver dyads were recruited through an activity center.
DESIGN, INTERVENTION


The impact of additional services delivered to both care-recipient and caregiver through video conference (n = 30) was compared with telehealth targeted at caregivers by telephone only (n = 30), over 4 weeks in a pretest-post-test design. Interviews and questionnaires were conducted at baseline and study's end.
MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50). It also reversed the falling trend in quality of life observed in the telephone only group (QoL-AD, η p 2  = 0.23). Varying degrees of improvements in physical and mental health (Short-Form 36 v2), perceived burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale) were observed among caregivers in the video-conferencing group, which were absent in the telephone-only group (η p 2  = 0.23-0.51).
CONCLUSION


Telemedicine by video conference was associated with improved resilience and wellbeing to both people with NCD and their caregivers at home. The benefits were visible already after 4 weeks and unmatched by telephone alone. Video conference as the modus operandi of telehmedicine beyond the context of pandemic-related social distancing should be considered.",2020,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","['Persons With Dementia and Their Caregivers During the COVID-19 Pandemic', 'Sixty older adults NCD-and-caregiver dyads were recruited through an activity center', 'older adults with neurocognitive disorder (NCD) and their caregivers']","['additional services delivered to both care-recipient and caregiver through video conference (n\u202f=\u202f30) was compared with telehealth targeted at caregivers by telephone', 'Telemedicine']","['physical and mental health', 'quality of life', 'burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale', 'Montreal Cognitive Assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",60.0,0.061643,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department (EWHY), Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Salvation Army Hong Kong & Macau Command, Tai Po Multi-service Centre for Senior Citizen.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Women's Welfare Club Western District, Hong Kong Chung Hok Elderly Centre, Hong Kong, China.""}, {'ForeName': 'Daniel Ting-Hoi', 'Initials': 'DT', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Yee', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.07.019']
2580,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
2581,32873675,Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).,"INTRODUCTION


The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
METHODS AND ANALYSIS


This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.
ETHICS AND DISSEMINATION


This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.
TRIAL REGISTRATION NUMBER


NCT03404583.",2020,"Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
","['patients on sick leave due to common mental disorders', '220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date']","['control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform', 'Person-centred care (PCC', 'Person-centred eHealth intervention']",['composite score of changes in sick leave and self-efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",220.0,0.164427,"Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
","[{'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Cederberg', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden matilda.cederberg@gu.se.'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Ekman', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Glise', 'Affiliation': 'The Institute of Stress Medicine, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Ingibjörg H', 'Initials': 'IH', 'LastName': 'Jonsdottir', 'Affiliation': 'The Institute of Stress Medicine, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2020-037515']
2582,32873678,Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol.,"INTRODUCTION


Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE).
METHODS AND ANALYSIS


The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m 2  or ≥35 kg/m 2  with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50 kg/m 2  will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group.
ETHICS AND DISSEMINATION


The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


NCT03610256.",2020,The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage.,"['183 patients per group', 'obese patients with body mass index (BMI) ≥40\u2009kg/m 2  or ≥35']","['single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB', 'Roux-en-Y gastric bypass (RYGB', 'anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S', 'SADI-S to RYGB']","['efficacy and safety', 'nutritional status, metabolic outcomes, overall complication rates and quality of life', 'weight loss']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399975', 'cui_str': 'Bypass of ileum'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0839635,The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage.,"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, CarMeN Laboratory, INSERM 1060, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Tigran', 'Initials': 'T', 'LastName': 'Poghosyan', 'Affiliation': 'Department of Digestive, Oncologic and Bariatric Surgery; Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Inserm UMRS 1149, Université de Paris, Paris, France tigran.poghosyan@aphp.fr.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Delaunay', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Pelascini', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Iceta', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Sterkers', 'Affiliation': 'Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Barsamian', 'Affiliation': 'Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.'}, {'ForeName': 'Litavan', 'Initials': 'L', 'LastName': 'Khamphommala', 'Affiliation': 'Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bin Dorel', 'Affiliation': 'Clinical Research Unit, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Department of Biostatistics, Hospices Civils de Lyon, Hôpital Edouard Herriot, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': 'Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}]",BMJ open,['10.1136/bmjopen-2020-037576']
2583,32873681,Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma.,"INTRODUCTION


Mesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.
METHODS AND ANALYSIS


The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
ETHICS AND DISSEMINATION


Research ethics approval was granted by London - Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


ISRCTN-ISRCTN44351742 and ClinicalTrials.gov-NCT02040272.",2020,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"['pleural mesothelioma', 'patients with malignant pleural mesothelioma']","['surgery-(extended) pleurectomy decortication-versus no surgery', 'pleurectomy decortication versus no (extended) pleurectomy decortication']","['health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years', 'survival and/or quality of life', 'quality of life', 'survival', 'overall survival', 'median survival']","[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.206517,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Academic Division of Thoracic Surgery, Royal Brompton and Harefield NHS Trust, London, UK e.lim@rbht.nhs.uk.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'The Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Cardiothoracic Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Cancer Research UK Centre Leicester, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Department of Medicine, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waller', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Ali', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bille', 'Affiliation': ""Thoracic Surgery, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Fuller', 'Affiliation': 'Respiratory Medicine, South Tyneside NHS Foundation Trust, South Shields, UK.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Ionescu', 'Affiliation': 'Lung Cancer, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Keni', 'Affiliation': 'Oncology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Department of Thoracic Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Pek', 'Initials': 'P', 'LastName': 'Koh', 'Affiliation': 'Department of Oncology, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Mansy', 'Affiliation': 'Oncology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Milton', 'Affiliation': 'Thoracic Surgery Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Dakshinamoorthy', 'Initials': 'D', 'LastName': 'Muthukumar', 'Affiliation': 'Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Plymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shamash', 'Affiliation': 'Department of Medical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tasigiannopoulos', 'Affiliation': 'The Oncology Care Team, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Treece', 'Affiliation': 'Heamatology and Oncology Unit, North West Anglia NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Joyce', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Warnes', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038892']
2584,32873686,Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP) among hypertensive patients in Nepal: study protocol for a feasibility randomised controlled trial.,"INTRODUCTION


Uncontrolled blood pressure is one of the main risk factors for cardiovascular disease and death in Low-income and middle-income countries. Improvements to medication adherence and lifestyle changes can be assisted by using mobile phone text messaging interventions. This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
METHODS AND ANALYSIS


The TEXT4BP intervention will be tested using a two-arm parallel-group, unblinded, individually randomised controlled trial. This feasibility study would recruit 200 clinically diagnosed hypertensive patients aged 18-69 years, currently receiving blood pressure-lowering medication for more than 3 months, visiting a tertiary healthcare facility in Kathmandu, Nepal. A nested qualitative study will assess the acceptability of the short message service intervention. The intervention group will receive text messages containing information on hypertension, diet, medication and physical activity three times a week for 3 months. The control group will receive standard care. At baseline and 3 months, measures of medication adherence, salt intake, physical activity and blood pressure will be collected. Feasibility measures, such as differential rates of recruitment and attrition rates, will be calculated. Acceptability of text message interventions will be studied using usability measures and in-depth interviews among intervention group participants. This pilot study is not funded.
ETHICS AND DISSEMINATION


This study has received ethics approval from the University of New South Wales Human Research Ethics Committee B (HC190357), Nepal Health Research Council (302/2019) and Institutional Review Committee of Kathmandu Medical College and Teaching Hospital Kathmandu, Nepal (030520192). The findings of the study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12619001213134.",2020,"This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
","['hypertensive patients in Nepal', '200 clinically diagnosed hypertensive patients aged 18-69 years, currently receiving blood pressure-lowering medication for more than 3\u2009months, visiting a tertiary healthcare facility in Kathmandu, Nepal']","['Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP', 'text message interventions', 'TEXT4BP intervention', 'text messaging intervention']","['medication adherence, salt intake, physical activity and blood pressure', 'differential rates of recruitment and attrition rates']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",200.0,0.130284,"This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
","[{'ForeName': 'Buna', 'Initials': 'B', 'LastName': 'Bhandari', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia buna.bhandari@gmail.com.'}, {'ForeName': 'Padmanesan', 'Initials': 'P', 'LastName': 'Narasimhan', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Jayasuriya', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040799']
2585,32880909,"A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.","BACKGROUND


Significantly more patients with moderate-to-severe plaque psoriasis treated with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head trial achieved 100% improvement in Psoriasis Area and Severity Index (PASI 100) at week 12.
OBJECTIVES


To compare skin and nail clearance and patient-reported outcomes for ixekizumab vs. guselkumab, up to week 24.
METHODS


IXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined as static Physician's Global Assessment ≥ 3, PASI ≥ 12 and involved body surface area ≥ 10%. Statistical comparisons were performed using the Cochran-Mantel-Haenszel test stratified by pooled site. Time-to-first-event comparisons were performed using Kaplan-Meier analysis, and P-values were generated using adjusted log-rank tests stratified by treatment group. Cumulative days at clinical and patient-reported responses were compared by ancova. The trial was registered with ClinicalTrials.gov (NCT03573323).
RESULTS


Of the 1027 patients randomly assigned, 90% completed the trial (465 of 520 ixekizumab and 459 of 507 guselkumab). As early as week 2 and through week 16, more patients on ixekizumab achieved PASI 100 (P < 0·01). At week 24, ixekizumab was noninferior to guselkumab (50% vs. 52%, difference -2·3%), with no statistically significant difference in PASI 100 (P = 0·41). More patients receiving ixekizumab showed completely clear nails at week 24 (52% vs. 31%, P = 0·007). The median time to first PASI 50/75/90 and PASI 100 were 2 and 7·5 weeks shorter, respectively, for patients on ixekizumab vs. guselkumab (P < 0·001). Patients on ixekizumab also had a greater cumulative benefit, with more days at PASI 90 and 100, with Dermatology Life Quality Index of 0 or 1, and itch free (P < 0·05). The frequency of serious adverse events was 3% for each group, with no new safety signals.
CONCLUSIONS


Ixekizumab was noninferior to guselkumab in complete skin clearance and superior in clearing nails at week 24. Ixekizumab cleared skin more rapidly in patients with moderate-to-severe plaque psoriasis, with a greater cumulative benefit, than guselkumab. Overall, the safety findings were consistent with the known safety profile for ixekizumab.",2020,"At Week 24, ixekizumab was non-inferior to guselkumab (50% vs. 52%, difference: -2·3%), with no statistically significant difference in PASI 100 (p=0·414).","['1027 patients randomly assigned', ""IXORA-R enrolled adults with moderate-to-severe plaque psoriasis (static Physician's Global Assessment [sPGA] ≥3, PASI ≥12, and BSA ≥10"", 'patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis']","['ixekizumab', 'ixekizumab vs. guselkumab', 'Ixekizumab', 'Ixekizumab Versus Guselkumab']","['Dermatology Life Quality Index of 0 or 1, and itch-free (p<0·05', 'completely clear nails', 'skin and nail clearance', 'median time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1027.0,0.188148,"At Week 24, ixekizumab was non-inferior to guselkumab (50% vs. 52%, difference: -2·3%), with no statistically significant difference in PASI 100 (p=0·414).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St Louis, MO, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Deparment of Dermatology, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Crowley', 'Affiliation': 'Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield, CA, USA.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Guenther', 'Affiliation': 'Guenther Research Inc, London, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, ON, Canada.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vender', 'Affiliation': 'Dermatrials Research Inc, Hamilton, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Clinic for Dermatology, Venereology and Allergology, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, NIHR Manchester Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Elmaraghy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renda', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Inc., Waterloo, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19509']
2586,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
2587,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
2588,32876695,Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial.,"Importance


Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients.
Objective


To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS.
Design, Setting, and Participants


Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.
Interventions


Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148).
Main Outcomes and Measures


The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.
Results


A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.
Conclusions and Relevance


Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.
Trial Registration


ClinicalTrials.gov Identifier: NCT04327401.",2020,"At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004).","['41 intensive care units (ICUs) in Brazil', 'patients with COVID-19 and moderate or severe ARDS', 'Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020', 'Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19', '350 patients', '299 patients (mean [SD] age, 61 [14] years; 37% women', 'patients with COVID-19-associated ARDS']","['dexamethasone', 'Dexamethasone', 'standard care alone']","['cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores', 'mechanical ventilation duration', 'ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation', 'number of ventilator-free days', 'number of ventilator-free days (days alive and free of mechanical ventilation', 'Days Alive and Ventilator-Free', 'mean SOFA score', 'secondary infections', 'serious adverse events']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",299.0,0.228585,"At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004).","[{'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Flavia R', 'Initials': 'FR', 'LastName': 'Bueno', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Maria Vitoria A O', 'Initials': 'MVAO', 'LastName': 'Silva', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Franca P', 'Initials': 'FP', 'LastName': 'Baldassare', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Eduardo L V', 'Initials': 'ELV', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Ricardo A B', 'Initials': 'RAB', 'LastName': 'Moura', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Michele O', 'Initials': 'MO', 'LastName': 'Honorato', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Andre N', 'Initials': 'AN', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Guilherme B', 'Initials': 'GB', 'LastName': 'Olivato', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Righy', 'Affiliation': 'Instituto Estadual do Cérebro Paulo Niemeyer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Amendola', 'Affiliation': 'Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Roberta M L', 'Initials': 'RML', 'LastName': 'Roepke', 'Affiliation': 'Departamento de Cirurgia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela H M', 'Initials': 'DHM', 'LastName': 'Freitas', 'Affiliation': 'UTI Respiratória, Instituto do Coração (Incor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Forte', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Caio C F', 'Initials': 'CCF', 'LastName': 'Fernandes', 'Affiliation': 'Hospital Mario Covas, FMABC, Santo Andre, Brazil.'}, {'ForeName': 'Livia M G', 'Initials': 'LMG', 'LastName': 'Melro', 'Affiliation': 'Hospital Samaritano Paulista, São Paulo, Brazil.'}, {'ForeName': 'Gedealvares F S', 'Initials': 'GFS', 'LastName': 'Junior', 'Affiliation': 'Hospital Evangélico de Vila Velha, Vila Velha, Brazil.'}, {'ForeName': 'Douglas Costa', 'Initials': 'DC', 'LastName': 'Morais', 'Affiliation': 'Aché Laboratórios Farmacêuticos, São Paulo, Brazil.'}, {'ForeName': 'Stevin', 'Initials': 'S', 'LastName': 'Zung', 'Affiliation': 'Aché Laboratórios Farmacêuticos, São Paulo, Brazil.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.17021']
2589,32881305,"Effectiveness of active video game usage on body composition, physical activity level and motor proficiency in children with intellectual disability.","BACKGROUND


Interventions with active video games (AVGs) can promote physical activity (PA) and health and are compatible with a school setting. The needs of children with intellectual disability (ID) in this area have been neglected.
METHODS


A two-arm trial was conducted among 203 students with intellectual disability. The intervention group was prescribed a 12-week intervention with AVG. The control group continued with usual PA.
RESULTS


Children's BOT-2 short-form score increased in both the intervention and control groups. However, the AVG intervention had no statistically significant effect on children's body composition, PA and motor proficiency overall, or in analyses of subgroups based on age, body weight and comorbid autism.
CONCLUSION


Active video game intervention had no marked effect on body composition, PA and motor proficiency in children with intellectual disability. The reasons for the lack of effectivity of the intervention are discussed; these may provide better guidelines for future AVG intervention in children with intellectual disability.",2020,"However, the AVG intervention had no statistically significant effect on children's body composition, PA and motor proficiency overall, or in analyses of subgroups based on age, body weight and comorbid autism.
","['203 students with intellectual disability', 'children with intellectual disability', 'children with intellectual disability (ID']","['active video game', 'usual PA', 'Active video game intervention', 'active video games (AVGs']","['body composition, physical activity level and motor proficiency', 'BOT-2 short-form score', 'body composition, PA and motor proficiency', ""children's body composition, PA and motor proficiency overall""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",203.0,0.0292783,"However, the AVG intervention had no statistically significant effect on children's body composition, PA and motor proficiency overall, or in analyses of subgroups based on age, body weight and comorbid autism.
","[{'ForeName': 'Patrick Wing-Chung', 'Initials': 'PW', 'LastName': 'Lau', 'Affiliation': 'Department of Sport and Physical Education, Hong Kong Baptist University, Kowloon, Hong Kong.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Sport and Physical Education, Hong Kong Baptist University, Kowloon, Hong Kong.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'National Fitness Research Center, China Institute of Sport Science, Beijing, China.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12774']
2590,32878323,Effects of Physical Rehabilitation on Spatiotemporal Gait Parameters and Ground Reaction Forces of Patients with Intermittent Claudication.,"Chronic ischemia of the lower extremities often presents as intermittent claudication characterized by lower limb pain which subsides after a short break. This study aimed to provide an assessment of the spatiotemporal parameters of gait and ground reaction forces in patients with PAD participating in three forms of supervised physical training. A total of 80 subjects completed a three-month supervised physical rehabilitation program with three sessions per week. The subjects were assigned to one of three programs: group 1-standard walking training on a treadmill (TT); group 2-Nordic walking (NW) training; group 3-strength and endurance training comprised of NW with isokinetic resistance training (NW + ISO). Gait biomechanics tests (kinematic and kinetic parameters of gait) and a six-minute walk test were carried out before and after three months of physical training. Nordic walking training led to the greatest improvements in the gait pattern of patients with PAD and a significant increase in the absolute claudication distance and total gait distance. Combined training (NW + ISO) by strengthening the muscles of the lower extremities increased the amplitude of the general center of gravity oscillation to the greatest extent. Treadmill training had little effect on the gait pattern. Nordic walking training should be included in the rehabilitation of patients with PAD as a form of gait training, which can be conducted under supervised or unsupervised conditions.",2020,Nordic walking training led to the greatest improvements in the gait pattern of patients with PAD and a significant increase in the absolute claudication distance and total gait distance.,"['patients with PAD participating in three forms of supervised physical training', '80 subjects completed a three-month', 'Patients with Intermittent Claudication']","['supervised physical rehabilitation program', 'Nordic walking training', 'Treadmill training', 'Physical Rehabilitation', '1-standard walking training on a treadmill (TT); group 2-Nordic walking (NW) training; group 3-strength and endurance training comprised of NW with isokinetic resistance training (NW + ISO', 'Combined training (NW + ISO']","['Gait biomechanics tests (kinematic and kinetic parameters of gait', 'gait pattern', 'absolute claudication distance and total gait distance', 'Spatiotemporal Gait Parameters and Ground Reaction Forces']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0429887', 'cui_str': 'Claudication distance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",80.0,0.0172298,Nordic walking training led to the greatest improvements in the gait pattern of patients with PAD and a significant increase in the absolute claudication distance and total gait distance.,"[{'ForeName': 'Wioletta', 'Initials': 'W', 'LastName': 'Dziubek', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 35 Paderewskiego Street, 51-612 Wrocław, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Stefańska', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 35 Paderewskiego Street, 51-612 Wrocław, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Bulińska', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 35 Paderewskiego Street, 51-612 Wrocław, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Barska', 'Affiliation': 'Department of Cardiology, Jelenia Góra Valley Provincial Hospital Center, Ogińskiego 6, 58-501 Jelenia Góra, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Paszkowski', 'Affiliation': 'Department of Angiology, Diabetology and Hypertension, Wroclaw Medical University, Borowska 213, 50-556 Wrocław, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kropielnicka', 'Affiliation': 'WROVASC-An Integrated Cardiovascular Centre, Specialist District Hospital in Wroclaw, Centre for Research and Development, H. Kamieńskiego 73a, 51-124 Wroclaw, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Jasiński', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 35 Paderewskiego Street, 51-612 Wrocław, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rachwalik', 'Affiliation': 'Department of Angiology, Diabetology and Hypertension, Wroclaw Medical University, Borowska 213, 50-556 Wrocław, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Woźniewski', 'Affiliation': 'Department of Physiotherapy, University School of Physical Education, 35 Paderewskiego Street, 51-612 Wrocław, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Szuba', 'Affiliation': 'Department of Angiology, Diabetology and Hypertension, Wroclaw Medical University, Borowska 213, 50-556 Wrocław, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9092826']
2591,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
2592,32880601,"Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial.","Importance


Safe and effective therapies for untreated, advanced gastric/gastroesophageal junction (G/GEJ) cancer remain an unmet need.
Objective


To evaluate the antitumor activity of pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy alone in patients with untreated, advanced G/GEJ cancer with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater.
Design, Setting, and Participants


The phase 3 KEYNOTE-062 randomized, controlled, partially blinded interventional trial enrolled 763 patients with untreated, locally advanced/unresectable or metastatic G/GEJ cancer with PD-L1 CPS of 1 or greater from 200 centers in 29 countries between September 18, 2015, and May 26, 2017.
Interventions


Patients were randomized 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1 to 5 or capecitabine 1000 mg/m2 twice daily), or chemotherapy plus placebo, every 3 weeks.
Main Outcomes and Measures


Primary end points were overall survival (OS) and progression-free survival (PFS) in patients with PD-L1 CPS of 1 or greater or 10 or greater.
Results


A total of 763 patients were randomized to pembrolizumab (n = 256), pembrolizumab plus chemotherapy (n = 257), or chemotherapy (n = 250). The median (range) age of all patients in the study cohort was 62 (20-87) years; 554 of 763 (72.6%) were men. At final analysis, after a median (range) follow-up of 29.4 (22.0-41.3) months, pembrolizumab was noninferior to chemotherapy for OS in patients with CPS of 1 or greater (median, 10.6 vs 11.1 months; hazard ratio [HR], 0.91; 99.2% CI, 0.69-1.18). Pembrolizumab monotherapy was not superior to chemotherapy in patients with CPS of 1 or greater. Pembrolizumab prolonged OS vs chemotherapy in patients with CPS of 10 or greater (median, 17.4 vs 10.8 months; HR, 0.69; 95% CI, 0.49-0.97), but this difference was not statistically tested. Pembrolizumab plus chemotherapy was not superior to chemotherapy for OS in patients with CPS of 1 or greater (12.5 vs 11.1 months; HR, 0.85; 95% CI, 0.70-1.03; P = .05) or CPS of 10 or greater (12.3 vs 10.8 months; HR, 0.85; 95% CI, 0.62-1.17; P = .16) or for PFS in patients with CPS of 1 or greater (6.9 vs 6.4 months; HR, 0.84; 95% CI, 0.70-1.02; P = .04). Grade 3 to 5 treatment-related adverse event rates for pembrolizumab, pembrolizumab plus chemotherapy, and chemotherapy were 17%, 73%, and 69%, respectively.
Conclusions and Relevance


This phase 3 randomized clinical trial found that among patients with untreated, advanced G/GEJ cancer, pembrolizumab was noninferior to chemotherapy, with fewer adverse events observed. Pembrolizumab or pembrolizumab plus chemotherapy was not superior to chemotherapy for the OS and PFS end points tested.
Trial Registration


ClinicalTrials.gov Identifier: NCT02494583.",2020,"Pembrolizumab plus chemotherapy was not superior to chemotherapy for OS in patients with CPS of 1 or greater (12.5 vs 11.1 months; HR, 0.85; 95% CI, 0.70-1.03; P = .05) or CPS of 10 or greater (12.3 vs 10.8 months; HR, 0.85; 95% CI, 0.62-1.17; P = .16) or for PFS in patients with CPS of 1 or greater (6.9 vs 6.4 months; HR, 0.84; 95% CI, 0.70-1.02; P = .04).","['patients with untreated, advanced G/GEJ cancer', 'The median (range) age of all patients in the study cohort was 62 (20-87) years; 554 of 763 (72.6%) were men', 'Patients With First-line, Advanced Gastric Cancer', '763 patients with untreated, locally advanced/unresectable or metastatic G/GEJ cancer with PD-L1 CPS of 1 or greater from 200 centers in 29 countries between September 18, 2015, and May 26, 2017', 'patients with untreated, advanced G/GEJ cancer with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater', 'patients with CPS of 1 or greater', '763 patients']","['Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy', 'pembrolizumab', 'Pembrolizumab or pembrolizumab plus chemotherapy', 'pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1 to 5 or capecitabine 1000 mg/m2 twice daily), or chemotherapy plus placebo', 'Pembrolizumab monotherapy', 'pembrolizumab plus chemotherapy', 'pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy alone', 'Pembrolizumab plus chemotherapy', 'chemotherapy', 'Pembrolizumab prolonged OS vs chemotherapy']","['overall survival (OS) and progression-free survival (PFS', 'adverse event rates', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",763.0,0.505613,"Pembrolizumab plus chemotherapy was not superior to chemotherapy for OS in patients with CPS of 1 or greater (12.5 vs 11.1 months; HR, 0.85; 95% CI, 0.70-1.03; P = .05) or CPS of 10 or greater (12.3 vs 10.8 months; HR, 0.85; 95% CI, 0.62-1.17; P = .16) or for PFS in patients with CPS of 1 or greater (6.9 vs 6.4 months; HR, 0.84; 95% CI, 0.70-1.02; P = .04).","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Lucjan', 'Initials': 'L', 'LastName': 'Wyrwicz', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Kudaba', 'Affiliation': 'Latvian Oncology Center Rakus Gailezers, Riga, Latvia.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Pontifica Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hugo Raul', 'Initials': 'HR', 'LastName': 'Castro', 'Affiliation': 'Grupo Medico Angeles, Guatemala City, Guatemala.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Christie Hospital NHS Trust, Manchester, United Kingdom.'}, {'ForeName': 'Maria Ignez', 'Initials': 'MI', 'LastName': 'Braghiroli', 'Affiliation': 'Institute of Cancer of São Paolo, University of São Paolo, São Paolo, Brazil.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Karaseva', 'Affiliation': 'SPb SBHI Clinical Oncology, Dispensary, Russia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Caglevic', 'Affiliation': 'Clinica Alemana Santiago, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Villanueva', 'Affiliation': 'Hospital Clinico de la Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Eray', 'Initials': 'E', 'LastName': 'Goekkurt', 'Affiliation': 'Hematology Oncology Practice Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Kobe City Medical Center General Hospital, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Enzinger', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Northwestern Medicine, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kher', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Sukrut', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Kang', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital (HUVH) and Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain.""}]",JAMA oncology,['10.1001/jamaoncol.2020.3370']
2593,32880602,"Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: A Randomized Clinical Trial.","Importance


Prior studies have shown that only a small proportion of patients with hormone receptor (HR)-positive metastatic breast cancer (MBC) experience benefit from programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors given as monotherapy. There are data suggesting that activity may be greater with combination strategies.
Objective


To compare the efficacy of eribulin plus pembrolizumab vs eribulin alone in patients with HR-positive, ERBB2 (formerly HER2)-negative MBC.
Design, Setting, and Participants


Multicenter phase 2 randomized clinical trial of patients with HR-positive, ERBB2-negative MBC who had received 2 or more lines of hormonal therapy and 0 to 2 lines of chemotherapy.
Interventions


Patients were randomized 1:1 to eribulin, 1.4 mg/m2 intravenously, on days 1 and 8 plus pembrolizumab, 200 mg/m2 intravenously, on day 1 of a 21-day cycle or eribulin alone. At time of progression, patients in the eribulin monotherapy arm could cross over and receive pembrolizumab monotherapy.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS). Secondary end points were objective response rate (ORR) and overall survival (OS). Exploratory analyses assessed the association between PFS and PD-L1 status, tumor-infiltrating lymphocytes (TILs), tumor mutational burden (TMB), and genomic alterations.
Results


Eighty-eight patients started protocol therapy; the median (range) age was 57 (30-76) years, median (range) number of prior lines of chemotherapy was 1 (0-2), and median (range) number of prior lines of hormonal therapy was 2 (0-5). Median follow-up was 10.5 (95% CI, 0.4-22.8) months. Median PFS and ORR were not different between the 2 groups (PFS, 4.1 vs 4.2 months; hazard ratio, 0.80; 95% CI, 0.50-1.26; P = .33; ORR, 27% vs 34%, respectively; P = .49). Fourteen patients started crossover treatment with pembrolizumab; 1 patient experienced stable disease. All-cause adverse events occurred in all patients (grade ≥3, 65%) including 2 treatment-related deaths in the combination group, both from immune-related colitis in the setting of sepsis, attributed to both drugs. The PD-L1 22C3 assay was performed on archival tumor samples in 65 patients: 24 (37%) had PD-L1-positive tumors. Analysis indicated that PD-L1 status, TILs, TMB, and genomic alterations were not associated with PFS.
Conclusions and Relevance


In this randomized clinical trial of patients with HR-positive, ERBB2-negative MBC, the addition of pembrolizumab to eribulin did not improve PFS, ORR, or OS compared with eribulin alone in either the intention-to-treat or PD-L1-positive populations. Further efforts to explore the benefits of adding checkpoint inhibition to chemotherapy among less heavily pretreated patients are needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT03051659.",2020,"Median PFS and ORR were not different between the 2 groups (PFS, 4.1 vs 4.2 months; hazard ratio, 0.80; 95% CI, 0.50-1.26; P = .33; ORR, 27% vs 34%, respectively; P = .49).","['patients with HR-positive, ERBB2-negative MBC who had received 2 or more lines of hormonal therapy and 0 to 2 lines of chemotherapy', 'patients with hormone receptor (HR)-positive metastatic breast cancer (MBC', '65 patients: 24 (37%) had PD-L1-positive tumors', 'Eighty-eight patients started protocol therapy; the median (range) age was 57 (30-76) years', 'patients with HR-positive, ERBB2-negative MBC', 'Patients With Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer', 'patients with HR-positive, ERBB2 (formerly HER2)-negative MBC']","['PD-L1 22C3', 'pembrolizumab', 'eribulin plus pembrolizumab vs eribulin alone', 'Eribulin With or Without Pembrolizumab']","['PFS and PD-L1 status, tumor-infiltrating lymphocytes (TILs), tumor mutational burden (TMB), and genomic alterations', 'PD-L1 status, TILs, TMB, and genomic alterations', 'Median PFS and ORR', 'objective response rate (ORR) and overall survival (OS', 'Progression-Free Survival', 'adverse events', 'stable disease', 'median (range) number of prior lines of chemotherapy', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.259663,"Median PFS and ORR were not different between the 2 groups (PFS, 4.1 vs 4.2 months; hazard ratio, 0.80; 95% CI, 0.50-1.26; P = .33; ORR, 27% vs 34%, respectively; P = .49).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Romualdo', 'Initials': 'R', 'LastName': 'Barroso-Sousa', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Keenan', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Vaz-Luis', 'Affiliation': 'Unit Inserm 981, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Gerburg', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Medical Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Spring', 'Affiliation': 'Medical Oncology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Natalie Faye', 'Initials': 'NF', 'LastName': 'Sinclair', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pittenger', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Richardson', 'Affiliation': ""Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Dillon', 'Affiliation': ""Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Van Allen', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.3524']
2594,32878061,"Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial.","BACKGROUND


The introduction of modern sub-perception modalities has improved the efficacy of spinal cord stimulation (SCS) in refractory pain syndromes of the trunk and lower limbs. The objective of this study was to evaluate the effectiveness of low and high frequency SCS among patients with chronic pain.
MATERIAL AND METHODS


A randomised, semi-double-blind, placebo controlled, four period (4 × 2 weeks) crossover trial was conducted from August 2018 to January 2020. Eighteen patients with SCS due to failed back surgery syndrome and/or complex regional pain syndrome were randomised to four treatment arms without washout periods: (1) low frequency (40-60 Hz), (2) 1 kHz, (3) clustered tonic, and (4) sham SCS (i.e., placebo). The primary outcome was pain scores measured by visual analogue scale (VAS) preoperatively and during subsequent treatment arms.
RESULTS


Pain scores (VAS) reported during the preoperative period was M (SD) = 8.13 (0.99). There was a 50% reduction in pain reported in the low frequency tonic treatment group (M (SD) = 4.18 (1.76)), a 37% reduction in the 1 kHz treatment group (M (SD) = 5.17 (1.4)), a 34% reduction in the clustered tonic settings group (M (SD) = 5.27 (1.33)), and a 34% reduction in the sham stimulation group (M (SD) = 5.42 (1.22)). The reduction in pain from the preoperative period to the treatment period was significant in each treatment group ( p  < 0.001). Overall, these reductions were of comparable magnitude between treatments. However, the modality most preferred by patients was low frequency (55% or 10 patients).
CONCLUSIONS


The pain-relieving effects of SCS reached significance and were comparable across all modes of stimulation including sham. Sub-perception stimulation was not superior to supra-perception. SCS was characterised by a high degree of placebo effect. No evidence of carryover effect was observed between subsequent treatments. Contemporary neuromodulation procedures should be tailored to the individual preferences of patients.",2020,The reduction in pain from the preoperative period to the treatment period was significant in each treatment group ( p  < 0.001).,"['August 2018 to January 2020', 'Eighteen patients with SCS due to failed back surgery syndrome and/or complex regional pain syndrome', 'Chronic Pain Syndrome', 'patients with chronic pain']","['Sub-Perception and Supra-Perception Spinal Cord Stimulation', 'spinal cord stimulation (SCS', 'placebo', 'SCS (i.e., placebo', 'Placebo']","['reduction in pain', 'Pain scores (VAS', 'pain scores measured by visual analogue scale (VAS', 'carryover effect', 'pain']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",18.0,0.356922,The reduction in pain from the preoperative period to the treatment period was significant in each treatment group ( p  < 0.001).,"[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Sokal', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Malukiewicz', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kierońska', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murawska', 'Affiliation': ""Students' Scientific Circle at the Department of Neurosurgery, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.""}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Guzowski', 'Affiliation': ""Students' Scientific Circle at the Department of Neurosurgery, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Rudaś', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Paczkowski', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Rusinek', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Krakowiak', 'Affiliation': 'Department of Neurosurgery and Neurology, Jan Biziel University Hospital Nr 2, Ujejskiego 75 Street, 85-168 Bydgoszcz, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9092810']
2595,32878085,"Effects of Robot-Assisted Gait Training in Patients with Burn Injury on Lower Extremity: A Single-Blind, Randomized Controlled Trial.","This study investigated the effects of robot-assisted gait training (RAGT) on gait function in burn patients. Briefly, 40 burn patients were randomly divided into an RAGT group or a conventional training (CON) group. SUBAR ®  (Cretem, Korea) is a wearable robot with a footplate that simulates normal gait cycles. The RAGT group underwent 30 min of robot-assisted training using SUBAR ®  with 30 min of conventional physiotherapy once a day, 5 days a week for 12 weeks. Patients in the CON group received 30 min of overground gait training and range-of-motion (ROM) exercises twice a day for 5 days a week for 12 weeks. The RAGT group and the CON group underwent 60 min of training per day. The intervention frequency and duration did not differ between the RAGT group and the CON group. The main outcomes were functional ambulatory category (FAC); 6-min walking test (6MWT); visual analogue scale (VAS) during gait movement; ROM; and isometric forces of bilateral hip, knee, and ankle muscles before and after 12 weeks of training. The results of the VAS, FAC, and 6MWT (8.06 ± 0.66, 1.76 ± 0.56, and 204.41 ± 85.60) before training in the RAGT group improved significantly (4.41 ± 1.18, 4.18 ± 0.39, and 298.53 ± 47.75) after training (p < 0.001, p < 0.001, and p < 0.001). The results of the VAS, FAC, and 6MWT (8.00 ± 1.21, 1.75 ± 0.58, and 220.94 ± 116.88) before training in the CON group improved significantly (5.00 ± 1.03, 3.81 ± 1.05, and 272.19 ± 110.14) after training (p < 0.001, p < 0.001, and p = 0.05). There were differences in the improvement of results of the VAS, FAC, and 6MWT between groups after training, but they were not statistically significant (p = 0.23, p = 0.14, and p = 0.05). The isometric strengths of the right hip extensor (p = 0.02), bilateral knee flexor (p = 0.04 in the right, and p = 0.001 in the left), bilateral knee extensor (p = 0.003 in the right, and p = 0.002 in the left), bilateral ankle dorsiflexor (p = 0.04 in the right, and p = 0.02 in the left), and bilateral ankle plantarflexor (p = 0.001 in the right, and p = 0.008 in the left) after training were significantly improved compared with those before training in the RAGT group. The ROMs of the right knee extension (p = 0.03) and bilateral ankle plantarflexion (p = 0.008 in the right, and p = 0.03 in the left) were significantly improved compared with measurements before training in the RAGT. There were no significant differences of the isometric strengths and ROMs of the bilateral hip, knee, and ankle muscles after training in the CON group. There were significant improvements in the isometric strengths of the left knee flexor ( p  = 0.01), left ankle dorsiflexor ( p  = 0.01), and left ankle plantarflexor ( p  = 0.003) between the two groups. The results suggested that RAGT is effective to facilitate early recovery of muscles strength after a burn injury. This is the first study to evaluate the effectiveness of RAGT in patients with burns compared with those receiving conventional training. The absence of complications in burn patients provides an opportunity to enlarge the application area of RAGT.",2020,"There were differences in the improvement of results of the VAS, FAC, and 6MWT between groups after training, but they were not statistically significant (p = 0.23, p = 0.14, and p = 0.05).","['patients with burns compared with those receiving conventional training', '40 burn patients', 'Patients with Burn Injury on Lower Extremity', 'burn patients']","['RAGT group or a conventional training (CON', 'overground gait training and range-of-motion (ROM) exercises', 'Robot-Assisted Gait Training', 'RAGT', 'robot-assisted gait training (RAGT', 'CON', 'robot-assisted training using SUBAR ®  with 30 min of conventional physiotherapy']","['left ankle dorsiflexor', 'VAS, FAC, and 6MWT', 'bilateral knee extensor', 'isometric strengths of the left knee flexor', 'bilateral ankle plantarflexor', 'gait function', 'left ankle plantarflexor', 'bilateral ankle dorsiflexor', 'isometric strengths and ROMs of the bilateral hip, knee, and ankle muscles', 'bilateral knee flexor', 'ROMs of the right knee extension', 'bilateral ankle plantarflexion', 'functional ambulatory category (FAC); 6-min walking test (6MWT); visual analogue scale (VAS) during gait movement; ROM; and isometric forces of bilateral hip, knee, and ankle muscles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0230448', 'cui_str': 'Structure of left ankle'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C4281599', 'cui_str': 'Structure of left knee region'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C4281598', 'cui_str': 'Structure of right knee region'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",,0.0366852,"There were differences in the improvement of results of the VAS, FAC, and 6MWT between groups after training, but they were not statistically significant (p = 0.23, p = 0.14, and p = 0.05).","[{'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon 14584, Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Kuem Ju', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation & Assistive Technology, Korea National Rehabilitation Research Institute, National Rehabilitation Center, Seoul 01022, Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul 07247, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9092813']
2596,32878157,Skeletal Muscle Angiopoietin-Like Protein 4 and Glucose Metabolism in Older Adults after Exercise and Weight Loss.,"Angiopoietin-like protein 4 (ANGPTL4) is an adipokine that plays an important role in energy homoeostasis and lipid and lipoprotein metabolism. This study was designed to determine the effect of an exercise plus weight loss intervention on ANGPTL4 expression and its relationship with metabolic health. Thirty-five obese sedentary men ( n  = 18) and postmenopausal women ( n  = 17), (X  ±  SEM, age: 61  ±  1 years, BMI: 31.3  ±  0.7 kg/m 2 , VO 2 max: 21.7  ±  0.9 L/kg/min) completed a 6 month program of 3×/week aerobic exercise and 1×/week dietary instruction to induce weight loss (AEX + WL). Participants underwent vastus lateralis muscle biopsies, a hyperinsulinemic-euglycemic clamp, oral glucose tolerance tests and body composition testing. Basal skeletal muscle ANGPTL4 mRNA was lower in men than women ( p  < 0.01). Peroxisome proliferator-activated receptor (PPAR) alpha (PPARα) mRNA expression was higher in men than women ( p  < 0.05). There were no significance changes in serum or skeletal muscle ANGPTL4 (basal or insulin-stimulated) or muscle PPARα mRNA expression after AEX + WL. Muscle mRNA ANGPTL4 is correlated with serum ANGPTL4 ( r  = 0.41,  p  < 0.05), body fat ( r  = 0.64,  p  < 0.0001), and glucose utilization ( r  = 0.38,  p  < 0.05). AEX + WL does not change basal or insulin-stimulated skeletal muscle ANGPTL4 mRNA expression, suggesting other factors contribute to improved insulin sensitivity after the loss of body fat and improved fitness.",2020,Peroxisome proliferator-activated receptor (PPAR) alpha (PPARα) mRNA expression was higher in men than women ( p  < 0.05).,"['Thirty-five obese sedentary men ( n  = 18) and postmenopausal women ( n  = 17), ', 'X  ±  SEM, age: 61  ±  1 years, BMI: 31.3  ±  0.7 kg/m 2 , VO 2 max: 21.7  ±  0.9 L/kg/min) completed a 6 month program of 3×/week', 'Older Adults after Exercise and Weight Loss']","['AEX + WL', 'exercise plus weight loss intervention', 'Skeletal Muscle Angiopoietin-Like Protein 4 and Glucose Metabolism', 'aerobic exercise and 1×/week dietary instruction to induce weight loss (AEX + WL', 'vastus lateralis muscle biopsies, a hyperinsulinemic-euglycemic clamp, oral glucose tolerance tests and body composition testing']","['glucose utilization', 'serum or skeletal muscle ANGPTL4 (basal or insulin-stimulated) or muscle PPARα mRNA expression', 'Peroxisome proliferator-activated receptor (PPAR) alpha (PPARα) mRNA expression', 'body fat', 'Basal skeletal muscle ANGPTL4 mRNA']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C1637390', 'cui_str': 'mL/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C4318429', 'cui_str': 'Angiopoietin-like Protein 4'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C4318429', 'cui_str': 'Angiopoietin-like Protein 4'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0166415', 'cui_str': 'PPARalpha'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",,0.0172866,Peroxisome proliferator-activated receptor (PPAR) alpha (PPARα) mRNA expression was higher in men than women ( p  < 0.05).,"[{'ForeName': 'Guoyan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.'}, {'ForeName': 'Hefang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine, Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.'}]",Metabolites,['10.3390/metabo10090354']
2597,32881865,"Spatial spillover analysis of a cluster-randomized trial against dengue vectors in Trujillo, Venezuela.","BACKGROUND


The ability of cluster-randomized trials to capture mass or indirect effects is one reason for their increasing use to test interventions against vector-borne diseases such as malaria and dengue. For the same reason, however, the independence of clusters may be compromised if the distances between clusters is too small to ensure independence. In other words they may be subject to spillover effects.
METHODS


We distinguish two types of spatial spillover effect: between-cluster dependence in outcomes, or spillover dependence; and modification of the intervention effect according to distance to the intervention arm, or spillover indirect effect. We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index. We use a novel random effects Poisson spatial regression model. Spillover dependence is incorporated via an orthogonalized intrinsic conditional autoregression (ICAR) model. Spillover indirect effects are incorporated via the number of locations within a certain radius, set at 200m, that are in the intervention arm.
RESULTS


From the model with ICAR spatial dependence, and the degree of surroundedness, the intervention effect is estimated as 0.74-favouring the intervention-with a 95% credible interval of 0.34 to 1.69. The point estimates are stronger with increasing surroundedness within intervention locations.
CONCLUSION


In this trial there is some evidence of a spillover indirect effect of the intervention, with the Breteau index tending to be lower in locations which are more surrounded by locations in the intervention arm.",2020,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.",[],[],[],[],[],[],,0.0575248,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008576']
2598,32883389,A 6-month follow-up study on response and relapse rates following an acute trial of repetitive transcranial magnetic stimulation in patients with major depression.,"BACKGROUND


Little is known about the post-acute effects of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression. The present study focused on the 6-month follow-up of a sample of patients with major depression, after the completion of an acute 4 weeks rTMS trial, with the aim of evaluating response (in terms of sustained and late response) and relapse rates.
METHODS


Following the completion of an acute trial of rTMS (T0-T4), 31 drug-resistant depressed patients (bipolar or unipolar) entered a naturalistic follow-up period of 6 months, with three timepoints (T5, T6, and T7) during which they were assessed with the Hamilton Depression Rating Scale and the Young Mania Rating Scale.
RESULTS


Results showed that in the 6 months following an acute transcranial magnetic stimulation (TMS) trial, a higher rate of late responders was observed among previously acute TMS nonresponders (63.64%, 7 out of 11) compared to the rate of relapse among those who had acutely responded to TMS (10%, 2 out of 20). In addition, an overall high rate of maintained response (90%) was observed.
CONCLUSION


Present findings seem to support the possibility of obtaining a clinical response also after the end of an acute TMS trial in patients with major depression. The concomitant low rate of relapse observed at the end of follow-up along with a high rate of maintained response provides further support to the post-acute efficacy of TMS. Nonetheless, further controlled studies, with larger samples and longer follow-up observation, are needed to confirm the reported results.",2020,,['patients with Major Depression'],['repetitive Transcranial Magnetic Stimulation (rTMS'],['response and relapse rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0182227,,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Arici', 'Affiliation': 'Department of Mental Health and Addiction, ASST Vimercate, Vimercate, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Benatti', 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Cafaro', 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cremaschi', 'Affiliation': 'Department of Mental Health and Addiction, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Degoni', 'Affiliation': ""Department of Psychiatry, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pozzoli', 'Affiliation': ""Department of Psychiatry, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.""}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Oldani', 'Affiliation': ""Department of Psychiatry, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Molteni', 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Giorgetti', 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Priori', 'Affiliation': ""Department of Health Sciences, 'Aldo Ravelli' Research Center for Neurotechnology and Experimental Brain Therapeutics, University of Milan Medical School, Milan, Italy.""}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Viganò', 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': ""Dell'Osso"", 'Affiliation': ""Department of Biomedical and Clinical Sciences 'Luigi Sacco', Department of Mental Health, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.""}]",CNS spectrums,['10.1017/S1092852920001807']
2599,32886121,The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial.,"Importance


Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions.
Objective


To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions.
Design, Setting, and Participants


This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019.
Interventions


Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group).
Main Outcomes and Measures


Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality.
Results


We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, -0.7%; 95% CI, -2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, -29.3%; 95% CI, -42.1% to -13.5%; magnetic resonance imaging: difference, -3.4%; 95% CI, -8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
Conclusions and Relevance


In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented.
Trial Registration


ClinicalTrials.gov Identifier: NCT02015455.",2020,"We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
","['Adults Undergoing Spine Imaging', '250\u202f401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States', 'November 2018 to October 2019', 'Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year', 'individuals without back pain (intervention group', 'A total of 117\u202f455 patients (49.2%) were randomized to the control group, and 121\u202f431 patients (50.8', 'We enrolled 250\u202f401 participants (of whom 238\u202f886 [95.4%] met eligibility for this analysis, with 137\u202f373 [57.5%] women and 105\u202f497 [44.2%] aged >60 years) from 3278 primary care clinicians']",['standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data'],"['Health Care Utilization', 'cumulative spine-related RVUs', 'likelihood of opioid prescribing', 'adjusted median (interquartile range) RVU', 'Measures\n\n\nHealth care utilization', 'Rates of subsequent RVUs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C4274373', 'cui_str': 'Imaging report'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",250401.0,0.27778,"We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
","[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Jarvik', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Meier', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'James', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Services, University of Washington, Seattle.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Suri', 'Affiliation': 'Rehabilitation Care Services, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Kallmes', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Cherkin', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Deyo', 'Affiliation': 'Departments of Family Medicine and Internal Medicine, Oregon Health and Science University, Portland.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Safwan S', 'Initials': 'SS', 'LastName': 'Halabi', 'Affiliation': 'Department of Radiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Luetmer', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Avins', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Rundell', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Griffith', 'Affiliation': 'Department of Radiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Janna L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'Surgical Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bresnahan', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15713']
2600,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
2601,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
2602,32878758,Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOT Pilot  trial.,"INTRODUCTION


Postoperative pancreatic fistula (POPF) is still the most frequently occurring and clinically relevant complication after distal pancreatectomy (DP). Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF. The aim of this project (PREBOT Pilot ) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.
METHODS AND ANALYSIS


PREBOT Pilot  is an investigator-initiated, single-centre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups and an exploratory study design. 60 patients scheduled for DP will be randomised to intervention and control group. In the intervention group, patients will undergo preoperative endoscopic injection of BTX into the sphincter of Oddi, whereas in the control group no preoperative endoscopy will be performed. The combined primary endpoint is the occurrence of clinically relevant POPF and/or death within 30 days after DP. The secondary endpoints comprise further postoperative outcome parameters and quality of life up to 3 months after DP as well as safety and feasibility of the procedure. Statistical analysis is based on the modified intention-to-treat population, excluding patients without status post DP. For safety analysis, rates of adverse events (AEs) and serious AEs will be calculated with 95% CIs for group comparisons.
ETHICS, FUNDING AND DISSEMINATION


PREBOT Pilot  has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4043654) and the Ethics Committee of Heidelberg University (reference number AFmo-523/2019). This trial is supported by the German Federal Ministry of Education and Research (BMBF). The results of the trial will be presented at national and international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


DRKS00020401.",2020,Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF.,"['postoperative pancreatic fistula after distal pancreatectomy', '60 patients scheduled for DP']","['preoperative endoscopic BTX injection', 'BOTulinum toxin', 'botulinum toxin (BTX']","['postoperative outcome parameters and quality of life up to 3 months after DP as well as safety and feasibility of the procedure', 'rates of adverse events (AEs) and serious AEs', 'occurrence of clinically relevant POPF and/or death']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",60.0,0.192462,Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Klaiber', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sauer', 'Affiliation': 'Interdisciplinary Centre of Endoscopy, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Eike', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Patient Advocacy, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Buchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany thilo_hackert@med.uni-heidelberg.de.'}]",BMJ open,['10.1136/bmjopen-2020-036815']
2603,32878759,Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.,"INTRODUCTION


Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme).
METHODS AND ANALYSES


We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding.
ETHICS AND DISSEMINATION


Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences.
TRIAL REGISTRATION NUMBER


ISRCTN12698674.",2020,"The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity.","['people with neurogenic claudication from spinal stenosis', 'people with neurogenic claudication', 'Older people with Spinal Trouble (BOOST) programme']","['combined physical and psychological intervention', 'physiotherapist-delivered, combined physical and psychological intervention']","['fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.197664,"The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Comer', 'Affiliation': 'Musculoskeletal and Rehabilitation Services, Leeds Community Healthcare NHS Trust, Leeds, UK c.comer@leeds.ac.uk.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, New South Wales, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'The Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'The Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037121']
2604,32878764,"Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.","INTRODUCTION


Automated systems for ventilator management to date have been either fully heuristic rule-based systems or based on a combination of simple physiological models and rules. These have been shown to reduce the duration of mechanical ventilation in simple to wean patients. At present, there are no published studies that evaluate the effect of systems that use detailed physiological descriptions of the individual patient.The BEACON Caresystem is a model-based decision support system that uses mathematical models of patients' physiology in combination with models of clinical preferences to provide advice on appropriate ventilator settings. An individual physiological description may be particularly advantageous in selecting the appropriate therapy for a complex, heterogeneous, intensive care unit (ICU) patient population.
METHODS AND ANALYSIS


Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting. The trial will enrol 274 participants across multiple London National Health Service ICUs. The trial will use a primary outcome of duration of mechanical ventilation until successful extubation.
ETHICS AND DISSEMINATION


Safety oversight will be under the direction of an independent committee of the study sponsor. Study approval was obtained from the regional ethics committee of the Health Research Authority (HRA), (Research Ethic Committee (REC) reference: 17/LO/0887. Integrated Research Application System (IRAS) reference: 226610. Results will be disseminated through international critical care conference/symposium and publication in peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov under NCT03249623. This research is registered with the National Institute for Health Research under CPMS ID: 34831.",2020,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.",['274 participants across multiple London National Health Service ICUs'],"['Intensive Care Weaning (iCareWean) protocol', 'Intenive Care weaning (iCareWean']",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.189947,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Vizcaychipi', 'Affiliation': 'APMIC, Imperial College London, London, UK m.vizcaychipi@imperial.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Research Trial Unit, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dan Stleper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Center for Model-based Medical Decision Support, Aalborg Universitet, Aalborg, Denmark.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Anaesthetic Department, West Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Magill Department of Anaesthesia and Intensive Care Medicine, Chelsea and Westminster Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Osman', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Moreno-Cuesta', 'Affiliation': 'Anaesthetic Department, North Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Department of Health Science and Technology, Aalborg Universitet Institut for Medicin og Sundhedsteknologi, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-042145']
2605,32883108,Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF.,"BACKGROUND


In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure), dapagliflozin, added to guideline-recommended therapies, reduced the risk of mortality and heart failure (HF) hospitalization. We examined the frequency and significance of episodes of outpatient HF worsening, requiring the augmentation of oral therapy, and the effects of dapagliflozin on these additional events.
METHODS


Patients in New York Heart Association functional class II to IV, with a left ventricular ejection fraction ≤40% and elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide), were eligible. The primary outcome was the composite of an episode of worsening HF (HF hospitalization or an urgent HF visit requiring intravenous therapy) or cardiovascular death, whichever occurred first. An additional prespecified exploratory outcome was the primary outcome plus worsening HF symptoms/signs leading to the initiation of new, or the augmentation of existing, oral treatment.
RESULTS


Overall, 36% more patients experienced the expanded, in comparison with the primary, composite outcome. In the placebo group, 684 of 2371 (28.8%) patients and, in the dapagliflozin group, 527 of 2373 (22.2%) participants experienced the expanded outcome (hazard ratio, 0.73 [95% CI, 0.65-0.82];  P <0.0001). Each component of the composite was reduced significantly by dapagliflozin. Over the median follow-up of 18.2 months, the number of patients needed to treat with dapagliflozin to prevent 1 experiencing an episode of fatal or nonfatal worsening was 16. Among the 4744 randomly assigned patients, the first episode of worsening was outpatient augmentation of treatment in 407 participants (8.6%), an urgent HF visit with intravenous therapy in 20 (0.4%), HF hospitalization in 489 (10.3%), and cardiovascular death in 295 (6.2%). The adjusted risk of death from any cause (in comparison with no event) after an outpatient worsening was hazard ratio, 2.67 (95% CI, 2.03-3.52); after an urgent HF visit, the adjusted risk of death was hazard ratio, 3.00 (95% CI, 1.39-6.48); and after a HF hospitalization, the adjusted risk of death was hazard ratio, 6.21 (95% CI, 5.07-7.62).
CONCLUSION


In DAPA-HF, outpatient episodes of HF worsening were common, were of prognostic importance, and were reduced by dapagliflozin. Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03036124.",2020,"The adjusted risk of death from any cause (compared with no event) following an outpatient worsening was HR 2.67 (95%CI 2.03-3.52), after an urgent HF visit 3.00 (1.39-6.48) and after a HF hospitalization 6.21 (5.07-7.62).  ","['Methods:  Patients in New York Heart Association (NYHA) functional class II-IV, with a left ventricular ejection fraction ≤40%, and', 'Patients with Heart Failure and Reduced Ejection Fraction']","['placebo', 'Dapagliflozin', 'dapagliflozin']","['worsening HF symptoms/signs leading to initiation of new, or augmentation of existing, oral treatment', 'CV death', 'adjusted risk of death', 'risk of mortality and HF hospitalization', 'composite of an episode of worsening heart failure (HF hospitalization or urgent HF visit requiring intravenous [IV] therapy) or cardiovascular (CV) death, whichever occurred first', 'HF hospitalization']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",4744.0,0.207557,"The adjusted risk of death from any cause (compared with no event) following an outpatient worsening was HR 2.67 (95%CI 2.03-3.52), after an urgent HF visit 3.00 (1.39-6.48) and after a HF hospitalization 6.21 (5.07-7.62).  ","[{'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis (I.A.).'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., P.J., A.M.L., D.L., M.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany (M.B.).'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands (R.A.d.B.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (A.S.D., S.D.S.).""}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department of Cardiology, Medical University of Lodz, Poland (J.D.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'University of Calgary, Cumming School of Medicine and Libin Cardiovascular Institute, Alberta, Canada (J.H.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., P.J., A.M.L., D.L., M.S.).'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., P.J., A.M.L., D.L., M.S.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., P.J., A.M.L., D.L., M.S.).'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Argentina (F.A.M.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': ""Department of Cardiology, Montreal Heart Institute, Ontario, Canada (E.O'M.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.S.S.).""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., P.J., A.M.L., D.L., M.S.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (A.S.D., S.D.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia (S.T.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Ontario, Canada (S.V.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (K.F.D., P.S.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047480']
2606,32886102,Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial.,"Importance


Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.
Objective


To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.
Design, Setting, and Participants


Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018.
Interventions


Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51).
Main Outcomes and Measures


Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.
Results


Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).
Conclusions and Relevance


In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.
Trial Registration


Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.",2020,"events/h [95% CI, -26.8 to -8.4]; P < .001).","['102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial', 'Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled from August 2014 to November 2017, with follow-up until August 2018', 'Patients With Moderate or Severe Obstructive Sleep Apnea', 'adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery', 'adults with obstructive sleep apnea (OSA', 'patients with OSA']","['upper airway surgery vs ongoing medical management', 'Multilevel Upper Airway Surgery vs Medical Management', 'combined palatal and tongue surgery', 'Interventions\n\n\nMultilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n\u2009=\u200951) or ongoing medical management (eg, advice on sleep positioning, weight loss; n\u2009=\u200951']","['mean AHI', 'mean ESS', 'Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness', 'apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness', 'number of apnea and hypopnea events and patient-reported sleepiness', 'serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0776524,"events/h [95% CI, -26.8 to -8.4]; P < .001).","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'MacKay', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'A Simon', 'Initials': 'AS', 'LastName': 'Carney', 'Affiliation': 'Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chia', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Charles Perkins Centre, Faculty for Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'John-Charles', 'Initials': 'JC', 'LastName': 'Hodge', 'Affiliation': 'Ear Nose and Throat Department, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'Health Economics Unit, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Hollywood Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Eng H', 'Initials': 'EH', 'LastName': 'Ooi', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Pinczel', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'McArdle', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'The Memorial Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Stow', 'Affiliation': 'The Woolcock Clinic, University of Sydney, NSW, Australia.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Weaver', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, University of Washington, Seattle.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Charmaine M', 'Initials': 'CM', 'LastName': 'Woods', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Aeneas', 'Initials': 'A', 'LastName': 'Yeo', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",JAMA,['10.1001/jama.2020.14265']
2607,32888230,Comparative effects of varenicline or combination nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt.,"BACKGROUND AND AIMS


The phase-based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre-cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C-NRT) relative to nicotine patch monotherapy on pre-cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators.
DESIGN


Secondary mediation analysis of data from the open-label, randomized Wisconsin Smokers' Health Study 2, a comparative effectiveness trial of varenicline or C-NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach.
SETTING


Research clinics in Madison and Milwaukee, Wisconsin, USA.
PARTICIPANTS


A total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6).
INTERVENTIONS


Twelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling.
MEASUREMENTS


The primary abstinence outcome was biochemically verified 7-day point-prevalence abstinence 4 weeks post-target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre-cessation phase) to 4 weeks after (cessation phase) the TQD.
FINDINGS


Pre-cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34-0.79], smoking expectancies (aOR = 0.46-0.79) and quitting motivation (aOR = 1.35-7.21) significantly predicted 4-week post-TQD abstinence (P < 0.05). Significant varenicline mediation occurred via greater suppression in pre-cessation craving [mediated effect (ab) = 0.09, standard error (SE) = 0.03, 95% confidence interval (CI) = 0.04-0.14] and smoking expectancies (ab = 0.06, SE = 0.02, 95% CI = 0.02-0.12). C-NRT mediation occurred via greater reduction in pre-post-TQD changes in craving (ab = 0.04, SE = 0.02, 95% CI = 0.01-0.08) and expectancies (ab = 0.03, SE = 0.02, 95% CI = 0.001-0.07), relative to patch monotherapy.
CONCLUSION


Among adult smokers seeking to quit, varenicline seems to work through its effects on suppression of craving and smoking expectancies pre-cessation while combination nicotine replacement therapy mediation seems to work through cessation-related reduction in craving and smoking expectancies changes.",2020,"Pre-cessation and cessation mean levels and slopes of craving (AOR=0.34-0.79), smoking expectancies (AOR=0.46-0.79), and quitting motivation (AOR=1.35-7.21) significantly predicted 4-week post-TQD abstinence (p<.05).","['Research clinics in Madison and Milwaukee, Wisconsin, USA.\nPARTICIPANTS\n\n\n1,051 daily smokers motivated to quit smoking (52.5% female; M age  =48.1, SD 11.6', 'adult smokers seeking to quit', 'adults who smoked, recruited via media and community outreach']","['Varenicline or Combination Nicotine', 'varenicline ', 'varenicline', 'nicotine patch monotherapy', 'combination nicotine patch and nicotine lozenge therapy (n=421), both compared with 12 weeks of patch control condition (n=230), with individual smoking cessation counseling', 'varenicline or C-NRT, versus patch monotherapy', 'varenicline and combination nicotine replacement therapy (C-NRT', 'Replacement Therapy versus Patch Monotherapy']","['smoking expectancies', '7-day point-prevalence abstinence 4 weeks post-target quit day (TQD', 'Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation', 'pre-cessation craving', 'Pre-cessation and cessation mean levels and slopes of craving', 'expectancies', 'quitting motivation']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1253423', 'cui_str': 'Nicotine Lozenges'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1051.0,0.0354541,"Pre-cessation and cessation mean levels and slopes of craving (AOR=0.34-0.79), smoking expectancies (AOR=0.46-0.79), and quitting motivation (AOR=1.35-7.21) significantly predicted 4-week post-TQD abstinence (p<.05).","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15248']
2608,32888318,Higher order aberrations and axial elongation in combined 0.01% atropine with orthokeratology for myopia control.,"PURPOSE


To compare the changes in higher order aberrations (HOA's) for photopic and mesopic pupil diameters in children undergoing orthokeratology treatment (OK) or combined 0.01% atropine with orthokeratology treatment (AOK), and their association with axial elongation.
METHODS


Children aged 6 to <11 years with 1.00-4.00 D of myopia were randomly assigned to each treatment group. Photopic and mesopic pupil diameters were quantified using automated pupillometry and HOA's were measured with a Hartmann-Shack aberrometer and Badal system to control for accommodation. HOA's were rescaled to photopic and mesopic pupil diameters and fitted with a 6 th  order Zernike polynomial expansion. Axial length was measured using an optical biometer under cycloplegia.
RESULTS


Baseline and six-month data from 25 AOK and 28 OK participants were analysed. At the six-month visit, pupil diameter was larger in the AOK group under photopic conditions (3.70 ± 0.42 vs 3.12 ± 0.33 mm, p < 0.001), along with a range of HOA metrics [3 rd  to 6 th  order and higher order root mean square error values (HO RMS), all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03). Axial elongation was greater in the OK treatment group (0.05 ± 0.08 vs -0.01 ± 0.12 mm, p = 0.02). In the AOK group, axial elongation was correlated with the increase in photopic pupil diameter (r = -0.45, p = 0.02) and with several HOA metrics; however, these associations were not observed in the OK group.
CONCLUSION


AOK treatment resulted in increased photopic pupil size and HOA's, and significantly less axial elongation over a six-month period compared to OK treatment alone. The improved myopia control observed with combination 0.01% atropine and orthokeratology may be a result of an enhanced optical effect due to a larger photopic pupil size.",2020,"all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03).","['Children aged 6 to <11\xa0years with 1.00-4.00 D of myopia', 'children undergoing orthokeratology treatment (OK) or combined 0.01']","['atropine with orthokeratology treatment (AOK', 'atropine']","['Axial elongation', 'axial elongation', 'Photopic and mesopic pupil diameters', 'photopic pupil diameter', ""photopic pupil size and HOA's"", 'pupil diameter', 'Axial length', 'root mean square error values (HO RMS', 'Higher order aberrations and axial elongation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0626994,"all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Vincent', 'Affiliation': 'Contact Lens and Visual Optics Laboratory, School of Optometry and Vision Science, Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Alex L K', 'Initials': 'ALK', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'George P M', 'Initials': 'GPM', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Laser Eye Centre, Hong Kong, Hong Kong.'}, {'ForeName': 'Victor C P', 'Initials': 'VCP', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12730']
2609,32886536,System for High-Intensity Evaluation During Radiation Therapy (SHIELD-RT): A Prospective Randomized Study of Machine Learning-Directed Clinical Evaluations During Radiation and Chemoradiation.,"PURPOSE


Patients undergoing outpatient radiotherapy (RT) or chemoradiation (CRT) frequently require acute care (emergency department evaluation or hospitalization). Machine learning (ML) may guide interventions to reduce this risk. There are limited prospective studies investigating the clinical impact of ML in health care. The objective of this study was to determine whether ML can identify high-risk patients and direct mandatory twice-weekly clinical evaluation to reduce acute care visits during treatment.
PATIENTS AND METHODS


During this single-institution randomized quality improvement study (ClinicalTrials.gov identifier: NCT04277650), 963 outpatient adult courses of RT and CRT started from January 7 to June 30, 2019, were evaluated by an ML algorithm. Among these, 311 courses identified by ML as high risk (> 10% risk of acute care during treatment) were randomized to standard once-weekly clinical evaluation (n = 157) or mandatory twice-weekly evaluation (n = 154). Both arms allowed additional evaluations on the basis of clinician discretion. The primary end point was the rate of acute care visits during RT. Model performance was evaluated using receiver operating characteristic area under the curve (AUC) and decile calibration plots.
RESULTS


Twice-weekly evaluation reduced rates of acute care during treatment from 22.3% to 12.3% (difference, -10.0%; 95% CI, -18.3 to -1.6; relative risk, 0.556; 95% CI, 0.332 to 0.924;  P  = .02). Low-risk patients had a 2.7% acute care rate. Model discrimination was good in high- and low-risk patients undergoing standard once-weekly evaluation (AUC, 0.851).
CONCLUSION


In this prospective randomized study, ML accurately triaged patients undergoing RT and CRT, directing clinical management with reduced acute care rates versus standard of care. This prospective study demonstrates the potential benefit of ML in health care and offers opportunities to enhance care quality and reduce health care costs.",2020,"RESULTS


Twice-weekly evaluation reduced rates of acute care during treatment from 22.3% to 12.3% (difference, -10.0%; 95% CI, -18.3 to -1.6; relative risk, 0.556; 95% CI, 0.332 to 0.924;  P  = .02).","['accurately triaged patients undergoing RT and CRT, directing clinical management with reduced acute care rates versus standard of care', '963 outpatient adult courses of RT and CRT started from January 7 to June 30, 2019, were evaluated by an ML algorithm', 'Patients undergoing outpatient radiotherapy (RT) or chemoradiation (CRT) frequently require acute care (emergency department evaluation or hospitalization']","['ML', 'Radiation Therapy (SHIELD-RT', 'Machine Learning-Directed Clinical Evaluations', 'Machine learning (ML']","['rates of acute care', 'rate of acute care visits during RT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",963.0,0.0789516,"RESULTS


Twice-weekly evaluation reduced rates of acute care during treatment from 22.3% to 12.3% (difference, -10.0%; 95% CI, -18.3 to -1.6; relative risk, 0.556; 95% CI, 0.332 to 0.924;  P  = .02).","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Hong', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Neville C W', 'Initials': 'NCW', 'LastName': 'Eclov', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Nicole H', 'Initials': 'NH', 'LastName': 'Dalal', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Thomas', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stephens', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Malicki', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Shields', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Cobb', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Mowery', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Tenenbaum', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Palta', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01688']
2610,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
2611,32885875,"Comparison of short-term light disturbance, optical and visual performance outcomes between a myopia control contact lens and a single-vision contact lens.","PURPOSE


To compare the optical and visual performance of a dual-focus (DF) contact lens used for myopia control with a single-vision (SV) contact lens of the same material.
METHODS


A randomised, double-masked crossover study. Twenty-eight healthy, myopic volunteers between 18 and 32 years of age (23.49 ± 4.07 years) participated in this study. The sensory dominant eye for distance vision was determined. Refraction, best-corrected visual acuity (VA) and aberrations for 3 mm and 5 mm pupil diameters were quantified without a contact lens in situ. Subjects were fitted with two contact lens designs: DF and SV, both made of omafilcon A material. The Quality of Vision (QoV) questionnaire, over-refraction, best-corrected VA, stereopsis at 40 cm, best-corrected photopic and mesopic contrast sensitivity, light disturbance and aberrations were assessed 25 min after contact lens insertion.
RESULTS


There were no statistically significant differences in best-corrected VA and stereopsis between the baseline, DF and SV conditions. Photopic and mesopic contrast sensitivity were lower for the DF contact lens at all frequencies, with the exception of the mesopic contrast sensitivity at 18 cycles per degree (p = 0.23). Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001). No differences were found in higher order aberrations between baseline and the SV contact lens condition for each pupil diameter. QoV scores also revealed lower frequency, severity and bothersome scores with the SV contact lens than with the DF contact lens (p < 0.001).
CONCLUSIONS


The DF contact lens design decreased the psychophysical and psychometric visual quality scores in the short-term under dim-light conditions when compared with a single-vision contact lens design of the same material. VA and stereopsis were unaffected by the lens design.",2020,Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001).,"['myopia control with a single-vision (SV) contact lens of the same material', 'Twenty-eight healthy, myopic volunteers between 18 and 32\xa0years of age (23.49\xa0±\xa04.07\xa0years) participated in this study']","['myopia control contact lens and a single-vision contact lens', 'dual-focus (DF) contact lens']","['frequency, severity and bothersome scores', 'Photopic and mesopic contrast sensitivity', 'Refraction, best-corrected visual acuity (VA) and aberrations for 3\xa0mm and 5\xa0mm pupil diameters', 'psychophysical and psychometric visual quality scores', 'Quality of Vision (QoV) questionnaire, over-refraction, best-corrected VA, stereopsis at 40\xa0cm, best-corrected photopic and mesopic contrast sensitivity, light disturbance and aberrations', 'Higher order aberrations and light disturbance size and irregularity', 'QoV scores']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1688601', 'cui_str': 'Overrefraction'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",28.0,0.0580162,Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001).,"[{'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'García-Marqués', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Rute Juliana', 'Initials': 'RJ', 'LastName': 'Macedo-De-Araújo', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab), Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cerviño', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'García-Lázaro', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': 'McAlinden', 'Affiliation': 'Department of Ophthalmology, Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab), Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12729']
2612,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
2613,32892758,Imagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: randomised clinical trial.,"BACKGROUND


Investigation of treatments that effectively treat adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD) and are well tolerated by patients is needed to improve outcomes for this population.
AIMS


The purpose of this study was to compare the effectiveness of two trauma-focused treatments, imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR), for treating Ch-PTSD.
METHOD


We conducted an international, multicentre, randomised clinical trial, recruiting adults with Ch-PTSD from childhood trauma before 16 years of age. Participants were randomised to treatment condition and assessed by blind raters at multiple time points. Participants received up to 12 90-min sessions of either ImRs or EMDR, biweekly.
RESULTS


A total of 155 participants were included in the final intent-to-treat analysis. Drop-out rates were low, at 7.7%. A generalised linear mixed model of repeated measures showed that observer-rated post-traumatic stress disorder (PTSD) symptoms significantly decreased for both ImRs (d = 1.72) and EMDR (d = 1.73) at the 8-week post-treatment assessment. Similar results were seen with secondary outcome measures and self-reported PTSD symptoms. There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
CONCLUSIONS


ImRs and EMDR treatments were found to be effective in treating PTSD symptoms arising from childhood trauma, and in reducing other symptoms such as depression, dissociation and trauma-related cognitions. The low drop-out rates suggest that the treatments were well tolerated by participants. The results from this study provide evidence for the use of trauma-focused treatments for Ch-PTSD.",2020,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
","['A total of 155 participants were included in the final intent-to-treat analysis', 'adults with post-traumatic stress disorder from childhood trauma', 'adults with Ch-PTSD from childhood trauma before 16 years of age', 'adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD']","['Imagery rescripting and eye movement desensitisation and reprocessing as treatment', 'imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR', 'ImRs or EMDR, biweekly']","['self-reported PTSD symptoms', 'observer-rated post-traumatic stress disorder (PTSD) symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",155.0,0.104754,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
","[{'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Boterhoven de Haan', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fassbinder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Germany.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'van Es', 'Affiliation': 'PsyQ Amsterdam, Parnassia Group, the Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Menninga', 'Affiliation': 'PsyQ Beverwijk, Parnassia Group, the Netherlands.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Meewisse', 'Affiliation': 'Abate, Centre of Expertise in Anxiety and Psychotrauma, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Rijkeboer', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Kousemaker', 'Affiliation': 'Amstelveen, Sinai Centrum, the Netherlands.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, the Netherlands.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.158']
2614,32883736,Recipient and instructor perspectives of an adapted exercise-based fall prevention programme for adults aged 50+ years with vision impairment: a qualitative study nested within a randomised controlled trial.,"OBJECTIVE


Older adults with vision impairment currently have no access to tailored fall prevention programmes. Therefore, the purpose of this study, nested within an ongoing randomised controlled trial (RCT), is to document the adaptation of an existing fall prevention programme and investigate the perspectives of instructors involved in delivery and the older adults with vision impairment receiving the programme (recipients).
DESIGN


We documented programme adaptations and training requirements, and conducted semistructured, individual interviews with both the instructors and the recipients of the programme from 2017 to 2019. The content of each interview was analysed using behaviour change theory through deductive qualitative analysis.
SETTING


New South Wales and Australian Capital Territory, Australia.
PARTICIPANTS


The 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT. The 154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT.
RESULTS


Six key themes were identified relating to recipient (delivery aptitude, social norms, habit formation) and instructor (individualised adaptation, complimentary to scope of practice, challenges to delivery) perspectives. With initial training, instructors required minimal ongoing support to deliver the programme and made dynamic adaptations to suit the individual circumstances of each recipient, but cited challenges delivering the number of programme activities required. Recipient perspectives varied; however, most appreciated the delivery of the programme by instructors who understood the impact of vision impairment.
CONCLUSIONS AND IMPLICATIONS


This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
TRIAL REGISTRATION NUMBER


ACTRN12616001186448.",2020,"This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
","['older adults with vision impairment receiving the programme (recipients', 'New South Wales and Australian Capital Territory, Australia', 'adults aged 50+ years with vision impairment', '154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT', 'Older adults with vision impairment', 'older people with vision impairment', 'The 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT']",['adapted exercise-based fall prevention programme'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454764', 'cui_str': 'Australian Capital Territory'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]",[],,0.0590725,"This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dillon', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia lisa.dillon1@unsw.edu.au.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Ageing, Work and Health Research Unit, University of Sydney, Sydney, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten Bonrud', 'Initials': 'KB', 'LastName': 'Jakobsen', 'Affiliation': 'Injury Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Client Services, Guide Dogs NSW/ACT, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Tinsley', 'Affiliation': 'Client Services, Guide Dogs NSW/ACT, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038386']
2615,32883738,Mitigating the mistreatment of childbearing women: evaluation of respectful maternity care intervention in Ethiopian hospitals.,"OBJECTIVES


There is a lack of evidence on approaches to mitigating mistreatment during facility-based childbirth. This study compares the experiences of mistreatment reported by childbearing women before and after implementation of a respectful maternity care intervention.
DESIGN


A pre-post study design was undertaken to quantify changes in women's experiences of mistreatment during facility-based childbirth before and after the respectful maternity care intervention.
INTERVENTION


A respectful maternity care intervention was implemented in three hospitals in southern Ethiopia between December 2017 and September 2018 and it included training of service providers, placement of wall posters in labour rooms and post-training supportive visits for quality improvement.
OUTCOME MEASURES


A 25-item questionnaire asking women about mistreatment experiences was administered to 388 women (198 in the pre-intervention, 190 in the post-intervention). The outcome variable was the number of mistreatment components experienced by women, expressed as a score out of 25. Multilevel mixed-effects Poisson modelling was used to assess the change in mistreatment score from pre-intervention to post-intervention periods.
RESULTS


The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91). Women who had a complication during pregnancy (Aβ=1.17, 95% CI 1.01 to 1.34) and childbirth (Aβ=1.16, 95% CI 1.03 to 1.32) experienced a greater number of mistreatment components. On the other hand, women who gave birth by caesarean birth after trial of vaginal birth (Aβ=0.76, 95% CI 0.63 to 0.92) and caesarean birth without trial of vaginal birth (Aβ=0.68, 95% CI 0.47 to 0.98) experienced a lesser number of mistreatment components compared with those who had vaginal birth.
CONCLUSIONS


Women reported significantly fewer mistreatment experiences during childbirth following implementation of the intervention. Given the variety of factors that lead to mistreatment in health facilities, interventions designed to mitigate mistreatment need to involve structural changes.",2020,"The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91).","['388 women (198 in the pre-intervention, 190 in the post-intervention', ""women's experiences of mistreatment during facility-based childbirth before and after the respectful maternity care intervention"", 'three hospitals in southern Ethiopia between December 2017 and September 2018 and it included training of service providers, placement of wall posters in labour rooms and post-training supportive visits for quality improvement', 'childbearing women', 'Ethiopian hospitals']",['respectful maternity care intervention'],"['caesarean birth without trial of vaginal birth', 'number of mistreatment components', 'childbirth', 'complication during pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.125885,"The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91).","[{'ForeName': 'Anteneh', 'Initials': 'A', 'LastName': 'Asefa', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia antex98@yahoo.com.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Gebremedhin', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Tekle', 'Affiliation': 'Maternal and Child Health Directorate, Ministry of Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Sintayehu', 'Initials': 'S', 'LastName': 'Abebe', 'Affiliation': 'Amref Health Africa in Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Magge', 'Affiliation': 'Institute for Healthcare Improvement, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kermode', 'Affiliation': 'Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038871']
2616,32887558,A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.,"BACKGROUND


Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH.
METHODS


This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling.
RESULTS


Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
CONCLUSIONS


YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.",2020,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","['young people living with HIV in Tanzania', 'Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis', 'Mean age was 18.1\u2009years; 51% were female; and 84% were HIV-infected perinatally', 'young people living with HIV (YPLWH']","['A group-based mental health intervention', 'YPLWH', 'Tanzania-based SYV intervention', 'mental health intervention, Sauti ya Vijana (SYV', 'local standard-of-care (SOC']","['ART adherence and virologic outcomes', 'Feasibility and acceptability', 'Virologic suppression rates', 'mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA', 'ART adherence and virologic suppression', 'ART concentration values']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.18628,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","[{'ForeName': 'Dorothy E', 'Initials': 'DE', 'LastName': 'Dow', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA. Dorothy.dow@duke.edu.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': ""O'Donnell"", 'Affiliation': 'Duke University, Center for Health Policy and Inequalities Research, Durham, NC, USA.'}]",BMC public health,['10.1186/s12889-020-09380-3']
2617,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
2618,32891234,Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.,"BACKGROUND


Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania.
METHODS


In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556.
FINDINGS


Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
INTERPRETATION


Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care.
FUNDING


National Institute of Mental Health at the US National Institutes of Health.",2020,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","['adults with HIV initiating antiretroviral therapy in Tanzania', 'All participants were included in the primary intention-to-treat analysis', 'adults starting HIV treatment', 'adults aged 18 years or older with HIV who had started ART within the past 30 days', 'Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group', 'patients starting ART in Tanzania']",['tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10\u2008000 Tanzanian Shillings (TZS; about US$4·50) or 22\u2008500 TZS'],"['viral suppression', 'retention in care with viral suppression', 'incentive size and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",530.0,0.294879,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Fahey', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA. Electronic address: cfahey@berkeley.edu.'}, {'ForeName': 'Prosper F', 'Initials': 'PF', 'LastName': 'Njau', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania; Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katabaro', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rashid S', 'Initials': 'RS', 'LastName': 'Mfaume', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Natalino', 'Initials': 'N', 'LastName': 'Mwenda', 'Affiliation': 'Rasello, Dar es Salaam, Tanzania.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Bradshaw', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Padian', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30230-7']
2619,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
2620,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
2621,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
2622,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
2623,32883721,Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.,"INTRODUCTION


Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).
METHODS AND ANALYSIS


A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER


German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.",2020,"Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders.",['Two hundred eighty-six participants'],"['guided internet-based Acceptance and Commitment Therapy', 'Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT', 'ACT-based IMI', 'internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement', 'TAU']","['Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire', 'depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP', 'pain interference (Multidimensional Pain Interference scale; MPI', 'chronic pain', 'chronic pain-related disability']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0032741', 'cui_str': 'Positive reinforcement'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",286.0,0.249744,"Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders.","[{'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Research Methods, Ulm University, Ulm, Baden-Württemberg, Germany yannik.terhorst@uni-ulm.de.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ebert', 'Affiliation': 'GET.ON Institute, Hamburg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-034271']
2624,32883723,Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.,"INTRODUCTION


The traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusively comprised of people bereaved by a traumatic death. Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist. We further expect that reductions in symptom levels during treatment are associated with reductions of negative cognitions and avoidance behaviours and the experience of fewer accident-related stressors. Moreover, the effect of the quality of the therapeutic alliance on treatment effects and drop-out rates will be explored.
METHODS AND ANALYSIS


A two-arm (online CBT vs waiting list) open-label parallel randomised controlled trial will be conducted. Participants will complete questionnaires at pretreatment and 12 and 20 weeks after study enrolment. Eligible for participation are Dutch adults who lost a loved one at least 1 year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression. Multilevel modelling will be used.
ETHICS AND DISSEMINATION


Ethics approval has been received by the Medical Ethics Review Board of the University Medical Center Groningen (METc UMCG: M20.252121). This study will provide new insights in the effectiveness of online CBT for traumatically bereaved people. If the treatment is demonstrated to be effective, it will be made publicly accessible. Findings will be disseminated among lay people (eg, through newsletters and media performances), our collaborators (eg, through presentations at support organisations), and clinicians and researchers (eg, through conference presentations and scientific journal articles).
TRIAL REGISTRATION NUMBER


NL7497.",2020,"Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist.","['traumatically bereaved people', 'Eligible for participation are Dutch adults who lost a loved one at least 1\u2009year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression']","['grief-specific cognitive-behavioural therapy (CBT', 'Online cognitive-behavioural therapy', 'online CBT']","['negative cognitions and avoidance behaviours', 'symptom levels', 'PCBD, PTSD and depression symptom levels', 'traumatic death']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2242593', 'cui_str': 'Traumatic death'}]",,0.108639,"Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist.","[{'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Lenferink', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands l.i.m.lenferink@rug.nl.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'de Keijser', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Eisma', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Smid', 'Affiliation': 'ARQ Nationaal Psychotrauma Centre, Diemen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Boelen', 'Affiliation': 'Clinical Psychology, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035050']
2625,32883724,How and why a multifaceted intervention to improve adherence post-MI worked for some (and could work better for others): an outcome-driven qualitative process evaluation.,"OBJECTIVES


To explore (1) the extent to which a multicomponent intervention addressed determinants of the desired behaviours (ie, adherence to cardiac rehabilitation (CR) and cardiovascular medications), (2) the associated mechanism(s) of action and (3) how future interventions might be better designed to meet the needs of this patient population.
DESIGN


A qualitative evaluation embedded within a multicentre randomised trial, involving purposive semistructured interviews.
SETTING


Nine cardiac centres in Ontario, Canada.
PARTICIPANTS


Potential participants were stratified according to the trial's primary outcomes of engagement and adherence, resulting in three groups: (1) engaged, adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative. Participants who did not engage but had positive adherence outcomes were excluded. Individual domains of the Theoretical Domains Framework were applied as deductive codes and findings were analysed using a framework approach.
RESULTS


Thirty-one participants were interviewed. Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences. The behaviour of those with negative adherence outcomes was driven by beliefs about consequences, emotions and identity. As currently designed, the intervention failed to target these determinants for this subset of participants, resulting in partial engagement and poor adherence outcomes.
CONCLUSION


The intervention facilitated CR adherence through reinforcement, behavioural regulation, the provision of knowledge and social influence. To reach a broader and more diverse population, future iterations of the intervention should target aberrant beliefs about consequences, memory and decision-making and emotion.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry; NCT02382731.",2020,"Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences.","['Thirty-one participants were interviewed', 'Participants who did not engage but had positive adherence outcomes were excluded', 'Nine cardiac centres in Ontario, Canada', 'Potential participants', 'Participants who were engaged with positive adherence outcomes']",[],"['adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",31.0,0.0982231,"Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada laura.desveaux@wchospital.ca.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Saragosa', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Centre for Implementation Research, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'J-D', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Translation and Health Systems Research Program, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Noah Michael', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-036750']
2626,32892392,"Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial.","OBJECTIVE


To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
DESIGN


Multicentre, double-blind, randomised controlled superiority trial.
SETTING


Thirty-two hospitals in the Netherlands.
POPULATION


A total of 2292 women aged ≥18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.
METHODS


Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.
MAIN OUTCOME MEASURES


Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS.
SECONDARY OUTCOMES


perioperative and menstrual characteristics; transvaginal ultrasound measurements.
RESULTS


A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.
CONCLUSIONS


The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.
TWEETABLE ABSTRACT


Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.",2020,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","['1144 women', '2292 women ≥ 18 years undergoing a first CS', ' 32 hospitals in the Netherlands', '774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group']","['Single-layer unlocked closure and double-layer unlocked closure with the second layer imbricating the first', 'double-layer uterine closure after a first caesarean section (CS', 'single- versus double-layer uterine closure during caesarean section']","['niche prevalence', 'Number of days with postmenstrual spotting during one menstrual cycle nine months after CS', 'drop-out and amenorrhoea', 'perioperative and menstrual characteristics, transvaginal ultrasound measurements', 'Operative time', 'Mean number of postmenstrual spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1144.0,0.775289,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","[{'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Stegwee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ben', 'Affiliation': 'Department of Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Universiteit van Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Research School Grow Maastricht University, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cjm', 'Initials': 'C', 'LastName': 'de Groot', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jaf', 'Initials': 'J', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16472']
2627,32889867,mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors.,"OBJECTIVE


The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).
SUMMARY AND BACKGROUND DATA


Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov: NCT00355862), the effect of sirolimus on the recurrence of HCC after LT was investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data.
PATIENTS AND METHODS


Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence.
RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) ≥10 ng/mL and having used sirolimus for ≥3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49-0.59, P = 0.0079-0.0245).
CONCLUSIONS


mTOR-inhibitor treatment with sirolimus for ≥3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients.
CLINICAL TRIAL REGISTRATION


EudraCT: 2005-005362-36 CLINICALTRIALS.GOV:: NCT00355862.",2020,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","['Data from 508 patients of the intention-to-treat analysis', 'Patients With Active Tumors', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial', 'patients with an alpha-fetoprotein (AFP) ≥10']","['mTOR', 'sirolimus', 'Calcineurin inhibitors']","['OS, DFS, and HCC-recurrence', 'disease-free survival (DFS', 'overall survival (OS), DFS and a competing risk analysis for HCC recurrence', 'survival benefit', 'hazard for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.230694,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","[{'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Universitätsklinikum Frankfurt, Institut für Biostatistik und Mathematisches Modellierung, Frankfurt am Main, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Hôpital Paul Brousse, Centre Hépato Biliaire, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bachellier', 'Affiliation': 'Les Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Strasbourg, France.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Kiel, Germany.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Itxarone', 'Initials': 'I', 'LastName': 'Bilbao', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Servicio de Cirugía General, Unidad de Trasplante Hepatico, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brockmann', 'Affiliation': 'Universitätsklinikum Münster, Klinik für Allgemein- und ViszeralchirurgieMünster, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Burra', 'Affiliation': 'Università degli Studi di Padova, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Padova, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chazoullières', 'Affiliation': ""Hôpital Saint Antoine, Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Paris, France.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Cillo', 'Affiliation': 'Università di Padova, Azienda Ospedaliera di Padova, Chirurgia Epatobiliare e Trapianto Epatico, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Chirurgia terza e Chirurgia Toracica, Bergamo (BG), Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': ""Université Paris-Est Créteil Val-de-Marne, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Unite d'Hepatologie et de Transplantation Hepatique, Paris, France.""}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Ganten', 'Affiliation': 'Universitätsklinikum Heidelberg, Fürst Stirum Klinik Bruchsal, Bruchsal, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Centre Hospitalier Universitaire de Nice, Hôpital ARCHET 2, Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Nice Cedex, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heise', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Hoek', 'Affiliation': 'Leiden University Medical Center (LUMC), Dept. of Gastroenterology and Hepatology, Leiden, Netherlands.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Jamieson', 'Affiliation': ""Cambridge University Hospitals, NHS Foundation Trust, Addenbrooke's Hospital, Department of Surgery, Hills Road, Cambridge, United Kingdom.""}, {'ForeName': 'Koert P', 'Initials': 'KP', 'LastName': 'de Jong', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Department of Surgery, Div. of Hepato-Pancreatico-Biliary Surgery & Liver Transplantation, Groningen, Netherlands.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Klein', 'Affiliation': 'Universitätsklinikum Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Essen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Klempnauer', 'Affiliation': 'Medizinische Hochschule Hannover, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Hannover, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Kneteman', 'Affiliation': 'University of Alberta, Alberta Health Services Liver Transplant Program, Alberta, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lerut', 'Affiliation': 'Institute for Experimental and Clinical Research (IREC), Université catholique Louvain(UCL), Brussels, Belgium.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Helsinki University Central Hospital, Division of Transplantation and Liver Surgery, Helsinki, Finland.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Darius F', 'Initials': 'DF', 'LastName': 'Mirza', 'Affiliation': 'University Hospitals Birmingham, NHS Foundation Trust, The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Nadalin', 'Affiliation': 'Klinikum der Universität Tübingen, Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Neuhaus', 'Affiliation': 'Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Berlin, Germany.'}, {'ForeName': 'George-Philippe', 'Initials': 'GP', 'LastName': 'Pageaux', 'Affiliation': ""CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Service d'Hepato-Gastroentérologie et Transplantation Hepatique, Cedex 5, France.""}, {'ForeName': 'Antonio D', 'Initials': 'AD', 'LastName': 'Pinna', 'Affiliation': 'Universita di Bologna, Policlinico S. Orsola-Malpighi, Chirurgia Generale e dei Trapianti, Bologna, Italy.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Pirenne', 'Affiliation': 'UZ Leuven, Campus Gasthuisberg, Abdominale Transplantatiechirurgie, Leuven, Belgium.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Charité - Universitätsmedizin Berlin Augustenburger Platz 1, 13353 Berlin.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Powel', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, 51 Little France Crescent, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rentsch', 'Affiliation': 'Klinikum der Ludwig-Maximillians-Universität München-Großhadern, current affiliation: Klinikum Ingolstadt, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Ingolstadt, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rizell', 'Affiliation': 'Sahlgrenska University Hospital, Department of Surgery and Transplantation, Göteborg, Sweden.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Centro Trapianti Fegato, Pad Zonda I piano, Milano, Italy.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Rostaing', 'Affiliation': 'Department of Nephrology, Hemodialysis, Apheresis and Transplantation, Grenoble-Alpes University Hospital Center, Avenue du Maquis du Grésivaudan, La Tronche, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ""Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Hepatobiliary and Pancreatic Surgery Unit, Principal Pavillion, 1058 Rue St Denis Montreal, Quebec, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Scholz', 'Affiliation': 'Uppsala University Hospital, Deptartment for Transplant Surgery, Uppsala, Sweden.'}, {'ForeName': 'Utz', 'Initials': 'U', 'LastName': 'Settmacher', 'Affiliation': 'Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Soliman', 'Affiliation': 'Medizinische Universität Wien, AKH- Wien, Universitätsklinik für Chirurgie, Abteilung für Transplantation, Vienna, Austria.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Strasser', 'Affiliation': 'Royal Prince Alfred Hospital, AW Morrow Gastroenterology, and Liver Centre and Liver Transplant Unit, Camperdown, Sydney, Australia.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Söderdahl', 'Affiliation': 'Karolinska University Hospital, Department of Transplantation Surgery, Stockholm, Sweden.'}, {'ForeName': 'Roberto I', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'Ghent University Hospital and Medical School, Hepato- Biliary and Pancreatic Surgery, Ghent, Belgium.'}, {'ForeName': 'Victor Sánchez', 'Initials': 'VS', 'LastName': 'Turrión', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Departamento de Cirugía, Unidad de Trasplante Hepático, Calle Manuel de Falla 1, Madrid, Spain.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'University Hospital Regensburg, Department of Surgery, Franz-Josef-Strauss-Allee 11, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'University Hospital Regensburg, Department of Surgery and Section of Experimental Surgery, Franz-Josef-Strauss-Allee 11, Regensburg, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004280']
2628,32889869,Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).,"OBJECTIVE


The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).
SUMMARY BACKGROUND DATA


DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.
METHODS


We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed.
RESULTS


A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.
CONCLUSIONS


The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.",2020,No difference remained statistically significant at 12 months after the removal of the DJBL.,"['Patients With Metabolic Syndrome', '174 subjects', 'patients with MS', 'patients with metabolic syndrome (MS', 'A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes']","['Duodeno-Jejunal Bypass Liner', 'duodeno-jejunal bypass liner (DJBL) with conventional medical care']","['body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again', 'efficacy and safety', 'BMI loss', 'Efficacy and Safety', 'weight loss and glucose control', 'remission of MS', 'premature device explantation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}]",174.0,0.238675,No difference remained statistically significant at 12 months after the removal of the DJBL.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Caiazzo', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': 'CHU Lille, Department of Gastroenterology, Lille, France.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Raverdy', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Carette', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre Benite, France, CarMeN Laboratory, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Barthet', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Nord, Marseille, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Clinique d'endocrinologie, L'institut du thorax, CHU Nantes, Nantes, France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of General, Digestive and Metabolic Surgery, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Behal', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Fanette', 'Initials': 'F', 'LastName': 'Denies', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Verkindt', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pattou', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}]",Annals of surgery,['10.1097/SLA.0000000000004339']
2629,32897344,Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury.,"Importance


Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.
Objective


To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI.
Design, Setting, and Participants


Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher.
Interventions


Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309).
Main Outcomes and Measures


The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events.
Results


Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16).
Conclusions and Relevance


Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended.
Trial Registration


ClinicalTrials.gov Identifier: NCT01990768.",2020,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","['patients with moderate or severe TBI', 'patients with TBI', 'Eligible participants (N\u2009=\u20091280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher', '1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants', 'Patients With Moderate or Severe Traumatic Brain Injury', '20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017', 'patients with moderate to severe TBI']","['Out-of-Hospital Tranexamic Acid vs Placebo', 'placebo', 'tranexamic acid', 'hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309']","['mean Glasgow Coma Scale score, 8', 'favorable neurologic function', '28-day mortality, 6-month Disability Rating Scale score (range, 0', '6-month Disability Rating Scale score', 'progression of intracranial hemorrhage', '28-day mortality', '6-month neurologic outcome', 'progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events', '6-Month Functional Neurologic Outcomes', 'neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4305168', 'cui_str': 'Disability Rating Scale score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",96.0,0.74178,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Meier', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McKnight', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Delores', 'Initials': 'D', 'LastName': 'Kannas', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Frascone', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Bosarge', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Johannigman', 'Affiliation': 'Department of Surgery, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Cotton', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dries', 'Affiliation': 'Department of Surgery, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tibbs', 'Affiliation': 'Trauma Surgery, Texas Health Presbyterian Hospital, Dallas.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Richmond', 'Affiliation': 'Department of Emergency Medicine, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Myron L', 'Initials': 'ML', 'LastName': 'Weisfeldt', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tallon', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Garrett', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Zielinski', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Gandhi', 'Affiliation': 'Department of Surgery, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Schlamp', 'Affiliation': 'British Columbia Emergency Health Services, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jui', 'Affiliation': 'Department of Emergency Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Rizoli', 'Affiliation': ""Department of Surgery, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gamber', 'Affiliation': 'Department of Emergency Medicine, Medical City Plano, Plano, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fleming', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Vincent', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Hendrickson', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simonson', 'Affiliation': 'Emergency Medicine, Methodist Dallas Medical Center, Dallas, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klotz', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Witham', 'Affiliation': 'Trauma Surgery, Texas Health Harris Methodist Hospital, Ft Worth.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}]",JAMA,['10.1001/jama.2020.8958']
2630,32882863,Photobiomodulation Therapy in the Management of Burning Mouth Syndrome: Morphological Variations in the Capillary Bed.,"Burning mouth syndrome (BMS) is an idiopathic condition that manifests itself primarily with the onset of a burning sensation. The aim of this research was to perform photobiomodulation therapy (PBM) using a diode laser on the oral mucosa of BMS patients, followed by an objective evaluation of the morphological changes in the vascular bed underlying the mucosa using polarized light videocapillaroscopy. A group of 40 patients were included in the study. The patients were randomly divided into two groups (using simple randomization) as follows: 20 patients were assigned to the laser group and 20 patients were assigned to the placebo group. Each patient of the laser group received eight irradiations (with 4 Watt of power, wavelength 800 nm, energy 1200 Joules, irradiation time of 300 s, energy density 50 J/cm 2 , 60 mW continuous wave laser, and irradiance 180 mW/cm 2 ), twice a week, blinded to the type of irradiation administered, for four consecutive weeks. The patients in the placebo group underwent the same sessions as the other patients, the only difference was the non-emission of the laser. An initial check of the vascular bed was performed with a polarized light videocapillaroscope. This was followed by treatment with a therapeutic diode laser and a subsequent check with a videocapillaroscope. We observed that in the group of patients who underwent laser therapy, there was a lasting improvement in symptoms. The capillary oral bed of patients in the placebo group did not show any statistically significant difference ( p  > 0.05). In the laser group we observed the following: in the buccal mucosa the diameter of the capillary had a reduction of 3 μm; in the upper lip mucosa, there was a reduction of 3 μm; in the lower lip mucosa, there was a reduction of 3 μm; and in the dorsal lingual surface, there was a reduction of 2 μm. An increase in capillary length was also obtained in all irradiated regions in the laser group patients ( p  < 0.05). PBM induces microcirculatory changes that are still present over a long period of time, such as an improvement in the clinical picture. The improvement in the symptoms has been correlated to the reduction of the capillary diameter. The placebo effect only led to a temporary improvement in symptoms that were unrelated to changes in the microcirculatory pattern.",2020,An increase in capillary length was also obtained in all irradiated regions in the laser group patients ( p  < 0.05).,['A group of 40 patients were included in the study'],"['therapeutic diode laser', 'laser therapy', 'photobiomodulation therapy (PBM', 'PBM', 'Photobiomodulation Therapy', 'placebo', 'diode laser']",['capillary length'],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",20.0,0.0413454,An increase in capillary length was also obtained in all irradiated regions in the laser group patients ( p  < 0.05).,"[{'ForeName': 'Giuseppe Alessandro', 'Initials': 'GA', 'LastName': 'Scardina', 'Affiliation': 'Department of Surgical Oncological and Stomatological Disciplines, University of Palermo, 90121 Palermo, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Casella', 'Affiliation': 'Department of Surgical Oncological and Stomatological Disciplines, University of Palermo, 90121 Palermo, Italy.'}, {'ForeName': 'Giuseppa', 'Initials': 'G', 'LastName': 'Bilello', 'Affiliation': 'Department of Surgical Oncological and Stomatological Disciplines, University of Palermo, 90121 Palermo, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Messina', 'Affiliation': 'Department of Surgical Oncological and Stomatological Disciplines, University of Palermo, 90121 Palermo, Italy.'}]",Dentistry journal,['10.3390/dj8030099']
2631,32892655,"A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects: an open label, three-way, three-period, partial replicate crossover study.","Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period. In this study, 31 Indonesian subjects were enrolled and 28 subjects were completed the study. Serial blood samples were collected up to 72 h following drug administration. Plasma concentrations of telmisartan were determined using high-performance liquid chromatography method with fluorescence detector. The pharmacokinetic parameters of AUC 0-   t  , AUC 0-∞ , and  C   max  were assessed for bioequivalence. Bioequivalence acceptance was based on predefined criteria of 90% confidence interval (CI) of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for  C   max . The 90% CI for AUC 0-   t  , AUC 0-∞ , and  C   max  was 96.11-107.25%, 93.06-104.36%, and 94.23-127.01%, respectively. These results indicated that the two formulations of telmisartan were bioequivalent.",2020,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"['healthy Indonesian subjects', 'Healthy Indonesian Subjects', 'thirty-one Indonesian subjects were enrolled and twenty-eight subjects were completed the study']","['telmisartan', 'telmisartan tablets', 'Telmisartan', 'Two Telmisartan']","['Bioequivalence acceptance', 'pharmacokinetic parameters of AUC 0-t , AUC 0-∞ , and C max', 'Plasma concentrations of telmisartan']","[{'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1248097', 'cui_str': 'telmisartan Oral Tablet'}]","[{'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}]",31.0,0.0241416,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"[{'ForeName': 'Asti Swari', 'Initials': 'AS', 'LastName': 'Paramanindita', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yahdiana', 'Initials': 'Y', 'LastName': 'Harahap', 'Affiliation': 'Faculty of Pharmacy, University of Indonesia, Depok, Indonesia.'}, {'ForeName': 'Budi', 'Initials': 'B', 'LastName': 'Prasaja', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Tri Rahayu', 'Initials': 'TR', 'LastName': 'Wijayanti', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Windy', 'Initials': 'W', 'LastName': 'Lusthom', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Raden Efi', 'Initials': 'RE', 'LastName': 'Sofiah', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sandra', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yunia', 'Initials': 'Y', 'LastName': 'Trisari', 'Affiliation': 'P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia.'}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1820042']
2632,32895271,Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol.,"INTRODUCTION


A huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.
INTERVENTION


YOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.
METHODS AND ANALYSIS


This is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20-30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.
TRIAL REGISTRATION NUMBER


CTRI/2019/05/018893.",2020,Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM.,"['high risk people in India', 'people at high risk of T2DM', 'Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9\u2009mmol/L) and safe to participate in physical activities']","['type-2 diabetes prevention (YOGA-DP', 'T2DM prevention (YOGA-DP', 'Yoga programme', 'YOGA-DP is a structured lifestyle education and exercise programme', 'Physical activity and a healthy diet (healthy lifestyle', 'Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices']",['blood glucose levels'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.113295,Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM.,"[{'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Chattopadhyay', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK kaushik.chattopadhyay@nottingham.ac.uk.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamer', 'Affiliation': 'Institute Sport Exercise and Health, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Sheila Margaret', 'Initials': 'SM', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah Anne', 'Initials': 'SA', 'LastName': 'Lewis', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nandi Krishnamurthy', 'Initials': 'NK', 'LastName': 'Manjunath', 'Affiliation': 'Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India.'}, {'ForeName': 'Rukamani', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Bapu Nature Cure Hospital and Yogashram, Delhi, India.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Bapu Nature Cure Hospital and Yogashram, Delhi, India.'}, {'ForeName': 'David Ross', 'Initials': 'DR', 'LastName': 'Harper', 'Affiliation': 'Harper Public Health Consulting Limited, London, UK.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'London School of Hygiene And Tropical Medicine, London, UK.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036277']
2633,32895281,"Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial.","INTRODUCTION


Resuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the restrictive and liberal red blood cell (RBC) transfusion strategies.
METHODS AND ANALYSIS


This is a cluster-randomised, crossover, non-inferiority trial of patients with severe trauma at 22 hospitals that have been randomised in a 1:1 ratio based on the use of a restrictive or liberal transfusion strategy with target Hb levels of 70-90 or 100-120 g/L, respectively, during the first year. Subsequently, after 1-month washout period, another transfusion strategy will be applied for an additional year. RBC transfusion requirements are usually unclear on arrival at the emergency department. Therefore, patients with severe bleeding, which could lead to haemorrhagic shock, will be included in the trial based on the attending physician's judgement. Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit. The outcomes measured will include the 28-day survival rate after arrival at the emergency department (primary), the cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary). Demonstration of the non-inferiority of restrictive transfusion will emphasise its clinical advantages.
ETHICS AND DISSEMINATION


The trial will be performed according to the Japanese and International Ethical guidelines. It has been approved by the Ethics Committee of each participating hospital and The Japanese Association for the Surgery of Trauma (JAST). Written informed consent will be obtained from all patients or their representatives. The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018.",2020,Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit.,"['patients with severe bleeding, which could lead to haemorrhagic shock', 'patients with severe trauma at 22 hospitals']",['restrictive and liberal red blood cell (RBC) transfusion strategies'],"['28-day survival rate', 'cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.167684,Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit.,"[{'ForeName': 'Mineji', 'Initials': 'M', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Japan mineji@dream.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tagami', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'IIjima', 'Affiliation': 'GBS Japan Biostatistics, R&D, Amgen K.K, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kudo', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sekine', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Department of Emergency Medicine & Critical Care Medicine, Advanced Medical Emergency and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yumoto', 'Affiliation': 'Emergency, Critical Care, and Disaster Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Endo', 'Affiliation': 'Trauma and Acute Critical Care Centre, Medical Hospital of Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Emergency Medicine, Division of Acute Care Surgery, Teikyo University School of Medicine Graduate School of Medicine, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Matsumura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine, Chiba, Chiba, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Kushimoto', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-037238']
2634,32895283,"Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial.","INTRODUCTION


The US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  E xperiencing the  r isk of overutilising  o pioids among patients with chronic  n on-cancer pain in  a mbulatory care (ERONA) is the first-ever conducted trial that aims at investigating the effects of these two modes of learning on individuals' risk perception and behaviour in the long-term administration of WHO-III opioids in chronic non-cancer pain.
METHODS AND ANALYSIS


ERONA-an exploratory, randomised controlled online survey intervention trial with two parallel arms-will examine the opioid-associated risk perception and behaviour of four groups involved in the long-term administration of WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances. Participants will be randomly assigned to one of two online risk education interventions, description based or experiencebased. Both interventions will present the best medical evidence available. Participants will be queried at baseline and after intervention on their risk perception of opioids' benefit-harm ratio, their medical risk literacy and their current/intended risk behaviour (in terms of prescribing, taking or counselling, depending on study group). A follow-up will occur after 9 months, when participants will be queried on their actual risk behaviour. The study was developed by the authors and will be conducted by the market research institution IPSOS Health.
ETHICS AND DISSEMINATION


The study was approved by the Institutional Review Board of the Max Planck Institute for Human Development. Results will be disseminated through peer-reviewed journals, conference presentations and social media.
TRIAL REGISTRATION NUMBER


DRKS00020358.",2020,Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  ,"['WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances', 'patients with chronic non-cancer pain in ambulatory care (ERONA', 'patients with chronic  n on-cancer pain in  a mbulatory care (ERONA']","['online risk education interventions, description based or experiencebased']",[],"[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0546803,Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  ,"[{'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Wegwarth', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany wegwarth@mpib-berlin.mpg.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité, Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Schulte', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité, Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Joerg J', 'Initials': 'JJ', 'LastName': 'Meerpohl', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmucker', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Edris', 'Initials': 'E', 'LastName': 'Nury', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Brockmann', 'Affiliation': 'Institute for Theoretical Biology and Integrative Research, Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhoff', 'Affiliation': 'Department of Primary Care, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wind', 'Affiliation': 'Berlin Chamber of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goebel', 'Affiliation': 'Berlin Chamber of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': 'Drug Commission of the German Medical Association, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hertwig', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-037642']
2635,32895286,Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.,"INTRODUCTION


Despite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based  Expecting  intervention (NCT02125149) with pregnant women with obesity in community settings.
METHODS AND ANALYSIS


We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted  Expecting  intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol).
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04298125; Pre-results.",2020,We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community.,"['60 expecting women', 'pregnant women with obesity in community settings', 'pregnant women to community-based delivery']","['exercise intervention', 'research clinic-based  Expecting  intervention']","['number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery', 'ie, body mass index, blood pressure and total cholesterol']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",60.0,0.0791685,We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community.,"[{'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Swindle', 'Affiliation': 'Family and Preventive Medicine, University of Arkansas For Medical Sciences, Little Rock, Arkansas, USA tswindle@uams.edu.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}]",BMJ open,['10.1136/bmjopen-2020-038582']
2636,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
2637,32898855,Nudge interventions to reduce fish sauce consumption in Thailand.,"High sodium consumption is one of the four major risk factors contributing to non-communicable diseases around the world. Thailand has one of the highest rates of sodium consumption, with fish sauce being one of the main sources. The aim of this study was to examine whether changes in the micro-environment factors can affect fish sauce consumption behavior in a university setting in Thailand. We implemented four interventions (with one control) in five canteens across a Thai university. The study design was a Latin square, where the five canteens were randomized over five weeks to implement four interventions plus a control. Our interventions included behavior-oriented, cognitive-oriented, and affective-oriented nudges aimed to reduce the amount of fish sauce people add to their noodles during lunchtime at the university canteens. Results indicate that a simple change in how fish sauce was served can reduce fish sauce consumption. Serving fish sauce in a bowl with a spoon reduced the amount of fish sauce used per noodle bowl by 0.25 grams, compared to the normal condition where fish sauce is served in a bottle. Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl. The other two interventions, cognitive- and affective- oriented nudges, also showed reductions of fish sauce usage, but the differences were not statistically significant. The findings can be used for policy implementation to advocate the use of a smaller sized spoon and a bowl to serve fish sauce instead of a bottle to reduce sodium consumption among Thai people.",2020,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"['Thailand', 'a university setting in Thailand', 'Thai people']",[],['reductions of fish sauce usage'],"[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",5.0,0.01837,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"[{'ForeName': 'Manasigan', 'Initials': 'M', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Chalermpol', 'Initials': 'C', 'LastName': 'Chamchan', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Churnrurtai', 'Initials': 'C', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Kanyapat', 'Initials': 'K', 'LastName': 'Suttikasem', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gunn', 'Affiliation': 'Department of Public Health Sciences, College of Health and Human Services, University of North Carolina at Charlotte, Charlotte, North Carolina, United States of America.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0238642']
2638,32902647,Effect of Androgen Deprivation on Long-term Outcomes of Intermediate-Risk Prostate Cancer Stratified as Favorable or Unfavorable: A Secondary Analysis of the RTOG 9408 Randomized Clinical Trial.,,2020,,['Intermediate-Risk Prostate Cancer Stratified as Favorable or Unfavorable'],['Androgen Deprivation'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C0002844', 'cui_str': 'Androgen'}]",[],,0.082725,,"[{'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Daskivich', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Tighiouart', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Luu', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Rodgers', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15083']
2639,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
2640,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
2641,32889912,Intensive statin versus low-dose statin + ezetimibe treatment for fibrous cap thickness of coronary vulnerable plaques.,"BACKGROUND


Acute coronary syndromes mainly result from abrupt thrombotic occlusion caused by atherosclerotic vulnerable plaques (VPs) that suddenly rupture or erosion. Fibrous cap thickness (FCT) is a major determinant of the propensity of a VP to rupture and is recognized as a key factor. The intensive use of statins is known to have the ability to increase FCT; however, there is a risk of additional adverse effects. However, lower dose statin with ezetimibe is known to be tolerable by patients. The present study aimed to investigate the effect of intensive statin vs. low-dose stain + ezetimibe therapy on FCT, as evaluated using optical coherence tomography.
METHOD


Patients who had VPs (minimum FCT <65 μm and lipid core >90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial. They were divided into the following two groups: intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe 10 mg). At the 12-month follow-up, we compared the change in the FCT (ΔFCT%) between the two groups and analyzed the association of ΔFCT% with risk factors. Fisher exact test was used for all categorical variables. Student's t test or Mann-Whitney U-test was used for analyzing the continuous data. The relationship between ΔFCT% and risk factors was analyzed using linear regression analysis.
RESULT


Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group. At the 12-month follow-up, the serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels were reduced in both the groups. The ΔTC%, ΔLDL-C%, and ΔLp-PLA2% were decreased further in the combination therapy group. FCT was increased in both the groups (combination treatment group vs. intensive statin group: 128.89 ± 7.64 vs. 110.19 ± 7.00 μm, t = -9.282, P < 0.001) at the 12-month follow-up. The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001). Based on the multivariate linear regression analysis, only the serum Lp-PLA2 at the 12-month follow-up (B = -0.203, t = -2.701, P = 0.010), ΔTC% (B = -0.573, t = -2.048, P = 0.046), and Δhs-CRP% (B = -0.302, t = -2.963, P = 0.005) showed an independent association with ΔFCT%.
CONCLUSIONS


Low-dose statin combined with ezetimibe therapy maybe provide a profound and significant increase in FCT as compared to intensive statin monotherapy. The reductions in Lp-PLA2, ΔTC%, and Δhs-CRP% are independently associated with an increase in FCT.",2020,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","['Patients who had VPs (minimum FCT', 'fibrous cap thickness of coronary vulnerable plaques', 'Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group', '90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial']","['intensive statin vs. low-dose stain + ezetimibe therapy', 'ezetimibe', 'Intensive statin versus low-dose statin + ezetimibe', 'Fibrous cap thickness (FCT', 'intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe']","['serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels', 'ΔFCT', 'FCT', 'Lp-PLA2, ΔTC%, and Δhs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031667', 'cui_str': 'Phospholipase A>2<'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",53.0,0.0232764,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","[{'ForeName': 'Pei-Na', 'Initials': 'PN', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'De-Lu', 'Initials': 'DL', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu 222000, China.""}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Xiang-Qi', 'Initials': 'XQ', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001067']
2642,32895879,Modelling the cost-effectiveness of person-centred care for patients with acute coronary syndrome.,"BACKGROUND


Person-centred care has been shown to be cost-effective compared to usual care for several diseases, including acute coronary syndrome, in a short-term time perspective (< 2 years). The cost-effectiveness of person-centred care in a longer time perspective is largely unknown.
OBJECTIVES


To estimate the mid-term cost-effectiveness of person-centred care compared to usual care for patients (< 65) with acute coronary syndrome, using a 2-year and a 5-year time perspective.
METHODS


The mid-term cost-effectiveness of person-centred care compared to usual care was estimated by projecting the outcomes observed in a randomized-controlled trial together with data from health registers and data from the scientific literature, 3 years beyond the 2-year follow-up, using the developed simulation model. Probabilistic sensitivity analyses were performed using Monte Carlo simulation.
RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective. Monte Carlo simulations suggest that the likelihoods of the person-centred care being cost-effective compared to usual care were between 80 and 99% and between 75 and 90% for a 2-year and a 5-year time perspective (using a 500,000 SEK/QALY willingness-to-pay threshold).
CONCLUSIONS


Person-centred care was less costly and more effective compared to usual care in a 2-year and a 5-year time perspective for patients with acute coronary syndrome under the age of 65.",2020,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","['patients (<\u200965) with acute coronary syndrome, using a 2-year and a 5-year time perspective', 'patients with acute coronary syndrome', 'patients with acute coronary syndrome under the age of 65']",['person-centred care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],,0.0392597,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pirhonen', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden. laura.pirhonen@economics.gu.se.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Bolin', 'Affiliation': 'Centre for Health Economics (CHEGU), Department of Economics, University of Gothenburg, Gothenburg, Sweden.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01230-8']
2643,32896294,"Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial.","BACKGROUND


Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.
METHODS


In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.
FINDINGS


Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.
INTERPRETATION


Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery.
FUNDING


UK National Institute of Health Research Health Technology Assessment Program.",2020,"There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93).","['487 participants randomly assigned to', 'patients undergoing major elective surgery', 'patients with anaemia 10-42 days before elective major abdominal surgery', 'adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres', 'anaemic patients before major open elective abdominal surgery']","['secure web-based service to receive intravenous iron or placebo', 'placebo', 'Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT', 'ferric carboxymaltose in 100 mL normal saline, and placebo']","['blood transfusions', 'risk of the composite outcome of blood transfusion or death, and number of blood transfusions', 'Anaemia', 'Death or blood transfusion']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",487.0,0.805107,"There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93).","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Division of Surgery, University of Western Australia, Fiona Stanley Hospital, Perth, WA, Australia; Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK. Electronic address: toby.richards@uwa.edu.au.'}, {'ForeName': 'Ravishankar Rao', 'Initials': 'RR', 'LastName': 'Baikady', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Clevenger', 'Affiliation': 'Department of Anaesthesia, Royal National Orthopaedic Hospital, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Butcher', 'Affiliation': 'Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Abeysiri', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Chau', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Murphy', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Swinson', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University Department of Vascular Surgery, Birmingham University, Solihull Hospital, Solihull, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies, and German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31539-7']
2644,32899926,"Effect of a Concurrent Cognitive Task, with Stabilizing Visual Information and Withdrawal, on Body Sway Adaptation of Parkinsonian's Patients in an Off-Medication State: A Controlled Study.","Background : In persons with Parkinson's disease (pwPD) any additional somatosensory or distractor interference can influence the posture. When deprivation of vision and dual-task are associated, the effect on biomechanical performance is less consistent. The aim of this study was to evaluate the role of the visual deprivation and a cognitive task on the static balance in earlier stage PD subjects.  Methods:  Fifteen off-medication state pwPD (9 women and 6 men), 67.7 ± 7.3 years old, diagnosed PD since 5.4 ± 3.4 years, only Hoehn and Yahr state 2 and fifteen young control adults (7 women and 8 men) aged 24.9 ± 4.9 years, performed semi-tandem task under four randomized experimental conditions: eyes opened single-task, eyes closed single-task, eyes opened dual-task and eyes closed dual-task. The center of pressure (COP) was measured using a force plate and electromyography signals (EMG) of the ankle/hip muscles were recorded. Traditional parameters, including COP pathway length, ellipse area, mediolateral/anteroposterior root-mean-square and non-linear measurements were computed. The effect of vision privation, cognitive task, and vision X cognitive was investigated by a 2 (eyes opened/eyes closed) × 2 (postural task alone/with cognitive task) repeated-measures ANOVA after application of a Bonferroni pairwise correction for multiple comparisons. Significant interactions were further analyzed using post-hoc tests.  Results : In pwPD, both COP pathway length ( p  < 0.01), ellipse area ( p  < 0.01) and mediolateral/anteroposterior root-mean-square ( p  < 0.01) were increased with the eyes closed, while the dual-task had no significant effect when compared to the single-task condition. Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01). Similarly, all differences in EMG activity of pwPD were exclusively observed between eyes opened vs. eyes closed conditions, and especially for the forward leg's soleus ( p  < 0.01) and backward tibialis anterior ( p  < 0.01).  Conclusions : These results in pwPD without noticeable impairment of static balance encourage the assessment of both visual occlusion and dual-task conditions when the appearance of significant alteration during the dual-task could reveal the subtle worsening onset of the balance control.",2020,Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01).,"['Methods:  Fifteen off-medication state pwPD (9 women and 6 men), 67.7 ± 7.3 years old, diagnosed PD since 5.4 ± 3.4 years, only Hoehn and Yahr state 2 and fifteen young control adults (7 women and 8 men) aged 24.9 ± 4.9 years, performed semi-tandem task under four randomized experimental conditions: eyes', 'earlier stage PD subjects', ""Parkinsonian's Patients in an Off-Medication State"", ""persons with Parkinson's disease (pwPD""]","['× 2 (postural task alone/with cognitive task', ' ', 'vision privation, cognitive task, and vision X cognitive was investigated by a 2 (eyes opened/eyes closed', 'Concurrent Cognitive Task, with Stabilizing Visual Information and Withdrawal', 'opened single-task, eyes closed single-task, eyes opened dual-task and eyes closed dual-task']","['backward tibialis anterior', 'COP pathway length', 'static balance', 'center of pressure (COP', 'EMG activity of pwPD', 'COP pathway length, ellipse area, mediolateral/anteroposterior root-mean-square and non-linear measurements', 'Body Sway Adaptation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0033179', 'cui_str': 'Privation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",7.0,0.0138443,Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Delafontaine', 'Affiliation': 'CIAMS, University Paris-Sud, Université Paris-Saclay, 91405 Orsay, France.'}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-Universität zu Kiel, 24098 Kiel, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Marolleau', 'Affiliation': 'CIAMS, University Paris-Sud, Université Paris-Saclay, 91405 Orsay, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kratzenstein', 'Affiliation': 'CAU Motion Lab, Kiel University, Olshausenstraße 74, 24098 Kiel, Germany.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gouelle', 'Affiliation': 'ProtoKinetics, Havertown, PA 19083, USA.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185059']
2645,32914866,Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer without tumor PD-L1 expression: A pooled analysis of 3 randomized controlled trials.,"BACKGROUND


Pembrolizumab plus platinum-based chemotherapy has demonstrated improved clinical outcomes over chemotherapy alone in patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. This study pooled data from 3 randomized controlled trials to evaluate outcomes with pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced/metastatic NSCLC negative for PD-L1 (ie, a tumor proportion score < 1%).
METHODS


Individual patient data were pooled from KEYNOTE-021 cohort G (nonsquamous; NCT02039674), KEYNOTE-189 (nonsquamous; NCT02578680 and NCT03950674), and KEYNOTE-407 (squamous; NCT02775435). Treatment comprised pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel for squamous histology) or chemotherapy alone. Responses were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded, independent, central review. No α was assigned to this descriptive, exploratory analysis.
RESULTS


Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n = 155; squamous, n = 94; other, n = 7] and 188 on chemotherapy alone [nonsquamous, n = 83; squamous, n = 99; other, n = 6]). The median time from randomization to the data cutoff was 28.0 months (range, 14.7-55.4 months). Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy. Sixteen patients in the pembrolizumab plus chemotherapy arm completed 2 years of treatment; the objective response rate was 87.5% (95% CI, 61.7%-98.4%), and the 3-year OS rate was 100%. Adverse events (AEs) were experienced by 99.2% of the patients who received pembrolizumab plus chemotherapy and by 98.9% of the patients who received chemotherapy alone, with grade 3 or higher AEs occurring in 71.4% and 72.0%, respectively; immune-mediated AEs and infusion reactions were experienced by 29.0% and 12.4%, respectively.
CONCLUSIONS


Pembrolizumab plus chemotherapy demonstrated response and survival improvements with manageable safety in comparison with chemotherapy alone in PD-L1-negative advanced/metastatic NSCLC, and it is a standard-of-care first-line therapy for patients with advanced NSCLC, regardless of PD-L1 expression.
LAY SUMMARY


Some tumors produce a protein called programmed death ligand 1 (PD-L1), which interacts with the body's immune system and prevents an immune response against cancer. Antibody therapies such as pembrolizumab block interactions between tumor PD-L1 and the immune system and enable an immune response. Used alone, pembrolizumab provides benefit for patients with non-small cell lung cancer (NSCLC) tumors that produce PD-L1. However, when it is combined with chemotherapy, which can stimulate anticancer immune responses, pembrolizumab provides a benefit, regardless of tumor PD-L1 production. This article shows that among patients with NSCLC whose tumors produce no PD-L1, outcomes are better with pembrolizumab plus chemotherapy in comparison with chemotherapy alone.",2020,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","['patients with advanced non-small cell lung cancer without tumor PD-L1 expression', 'patients with non-small cell lung cancer (NSCLC) tumors', 'patients with advanced/metastatic NSCLC negative for PD-L1 ', 'patients with NSCLC', 'patients with advanced NSCLC', 'patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC', 'Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n\xa0=\xa0155; squamous, n\xa0=\xa094; other, n\xa0=\xa07] and 188 on chemotherapy alone [nonsquamous, n\xa0=\xa083; squamous, n\xa0=\xa099; other, n\xa0=\xa06']","['pembrolizumab', 'pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy versus chemotherapy alone', 'pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel', 'chemotherapy alone', 'Pembrolizumab plus platinum-based chemotherapy', 'Pembrolizumab plus chemotherapy']","['3-year OS rate', 'immune-mediated AEs and infusion reactions', 'Adverse events (AEs', 'median time', 'progression-free survival', 'objective response rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C4087225', 'cui_str': 'Immune-mediated adverse reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1328.0,0.416973,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Universidad Complutense and CIBERONC, Madrid, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Montefiore Einstein Center for Cancer Care, New York, New York.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Baerin', 'Initials': 'B', 'LastName': 'Houghton', 'Affiliation': 'Mid North Coast Cancer Institute, Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.'}]",Cancer,['10.1002/cncr.33142']
2646,32907366,Antithrombotic Effects of Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition.,"OBJECTIVE


PAR (protease-activated receptor)-4 antagonism has antiplatelet effects under conditions of high shear stress. We aimed to establish whether PAR4 antagonism had additive antithrombotic activity in the presence of factor Xa inhibition in an ex vivo model of acute arterial injury. Approach and Results: Fifteen healthy volunteers (29±6 years, 7 women) completed a phase zero double-blind randomized controlled crossover trial. Ex vivo platelet activation, platelet aggregation, and thrombus formation were measured following blood perfusion of low shear and high shear stress chambers. Upstream of the chambers, extracorporeal blood was admixed with (1) vehicle, (2) low-dose apixaban (20 ng/mL), (3) high-dose apixaban (80 ng/mL), (4) BMS-986141 (400 ng/mL), (5) BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban in 6 sequential studies performed in random order. Compared with vehicle, BMS-986141 demonstrated selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression ( P ≤0.01 for all). Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle). BMS-968141 reduced total (≤44.4%) and platelet-rich (≤39.3%) thrombus area, whereas apixaban reduced total (≤42.9%) and fibrin-rich (≤31.6%) thrombus area. Combination of BMS-986141 with apixaban caused a further modest reduction in total thrombus area (9.6%-12.4%), especially under conditions of high shear stress ( P ≤0.027).
CONCLUSIONS


In the presence of factor Xa inhibition, PAR4 antagonism with BMS-986141 further reduces thrombus formation, especially under conditions of high shear stress. This suggests the potential for additive efficacy of combination PAR4 antagonism and factor Xa inhibition in the prevention of atherothrombotic events.",2020,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"['Fifteen healthy volunteers (29±6 years, 7 women']","['Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition', 'PAR4 antagonism', 'combination PAR4 antagonism and factor', 'BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban', 'BMS-986141 with apixaban']","['Ex vivo platelet activation, platelet aggregation, and thrombus formation', 'fibrin-rich', 'platelet-rich', 'selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression', 'total thrombus area', 'Total thrombus area']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C1257901', 'cui_str': 'Proteinase-Activated Receptors'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",15.0,0.16133,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"[{'ForeName': 'Mohammed N', 'Initials': 'MN', 'LastName': 'Meah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raftis', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Perera', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Samira M', 'Initials': 'SM', 'LastName': 'Garonzik', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Murthy', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'J Gerry', 'Initials': 'JG', 'LastName': 'Everlof', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Luettgen', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314960']
2647,32907904,"Rationale and design of a randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated phase 2a study to investigate the efficacy and safety of elobixibat in combination with cholestyramine for non-alcoholic fatty liver disease.","INTRODUCTION


Non-alcoholic fatty liver disease (NAFLD) pathogenesis involves abnormal metabolism of cholesterol and hepatic accumulation of toxic free-cholesterol. Elobixibat (EXB) inhibits the ileal bile acid (BA) transporter. EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol. In this randomised, double-blind, placebo-controlled, parallel-group, phase IIa study, we aim to provide a proof-of-concept assessment by evaluating the efficacy and safety of EXB in combination with CTM in patients with NAFLD.
METHODS AND ANALYSIS


A total of 100 adult patients with NAFLD, diagnosed based on low-density lipoprotein cholesterol (LDL-C) level of >120 mg/dL and liver fat content of ≥8% by MRI-based proton density fat fraction (MRI-PDFF), who meet the inclusion/exclusion criteria will be enrolled. The patients will be randomly assigned to receive the combination therapy of 10 mg EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment (n=25 per group). Blood tests and MRIs will be performed 16 weeks following treatment initiation. The primary study endpoint will be the absolute LDL-C level change at week 16 after treatment initiation. The exploratory endpoint will include absolute changes in the liver fat fraction as measured by MRI-PDFF. This proof-of-concept study will determine whether the combination therapy of EXB and CTM is effective and safe for patients with NAFLD.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Yokohama City University Hospital before participant enrolment. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.
TRIAL REGISTRATION NUMBER


NCT04235205.",2020,"EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol.","['patients with NAFLD', 'non-alcoholic fatty liver disease', '100 adult patients with NAFLD, diagnosed based on low-density lipoprotein cholesterol (LDL-C) level of >120 mg/dL and liver fat content of ≥8% by MRI-based proton density fat fraction (MRI-PDFF), who meet the inclusion/exclusion criteria will be enrolled']","['CTM', 'Elobixibat (EXB', 'placebo', 'EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment', 'EXB and CTM', 'EXB', 'EXB and cholestyramine (CTM', 'cholestyramine']",['absolute LDL-C level change'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0008402', 'cui_str': 'Cholestyramine Resin'}, {'cui': 'C3659266', 'cui_str': 'elobixibat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",100.0,0.392601,"EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol.","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saigusa', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine Graduate School of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine Graduate School of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan nakajima-tky@umin.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2020-037961']
2648,32910709,Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial.,"PURPOSE


Given the poor results using hypofractionated radiotherapy for early breast cancer, a dose of 50 Gy in 25 fractions (fr) has been the standard regimen used by the Danish Breast Cancer Group (DBCG) since 1982. Results from more recent trials have stimulated a renewed interest in hypofractionation, and the noninferiority DBCG HYPO trial (ClincalTrials.gov identifier: NCT00909818) was designed to determine whether a dose of 40 Gy in 15 fr does not increase the occurrence of breast induration at 3 years compared with a dose of 50 Gy in 25 fr.
PATIENTS AND METHODS


One thousand eight hundred eighty-two patients > 40 years of age who underwent breast-conserving surgery for node-negative breast cancer or ductal carcinoma in situ (DCIS) were randomly assigned to radiotherapy at a dose of either 50 Gy in 25 fr or 40 Gy in 15 fr. The primary end point was 3-year grade 2-3 breast induration assuming noninferiority regarding locoregional recurrence.
RESULTS


A total of 1,854 consenting patients (50 Gy, n = 937; 40 Gy, n = 917) were enrolled from 2009-2014 from eight centers. There were 1,608 patients with adenocarcinoma and 246 patients with DCIS. The 3-year rates of induration were 11.8% (95% CI, 9.7% to 14.1%) in the 50-Gy group and 9.0% (95% CI, 7.2% to 11.1%) in the 40-Gy group (risk difference, -2.7%; 95% CI, -5.6% to 0.2%;  P  = .07). Systemic therapies and radiotherapy boost did not increase the risk of induration. Telangiectasia, dyspigmentation, scar appearance, edema, and pain were detected at low rates, and cosmetic outcome and patient satisfaction with breast appearance were high with either no difference or better outcome in the 40-Gy cohort compared with the 50-Gy cohort. The 9-year risk of locoregional recurrence was 3.3% (95% CI, 2.0% to 5.0%) in the 50-Gy group and 3.0% (95% CI, 1.9% to 4.5%) in the 40-Gy group (risk difference, -0.3%; 95% CI, -2.3% to 1.7%). The 9-year overall survival was 93.4% (95% CI, 91.1% to 95.1%) in the 50-Gy group and 93.4% (95% CI, 91.0% to 95.2%) in the 40-Gy group. The occurrence of radiation-associated cardiac and lung disease was rare and not influenced by the fractionation regimen.
CONCLUSION


Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy. Other normal tissue effects were minimal, with similar or less frequent rates in the 40-Gy group. The 9-year locoregional recurrence risk was low.",2020,Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy.,"['1,854 consenting patients (50 Gy, n = 937; 40 Gy, n = 917) were enrolled from 2009-2014 from eight centers', 'One thousand eight hundred eighty-two patients > 40 years of age who underwent breast-conserving surgery for node-negative breast cancer or ductal carcinoma in situ (DCIS', 'Patients With Early Breast Cancer or Ductal Carcinoma', '1,608 patients with adenocarcinoma and 246 patients with DCIS']","['DCIS', 'radiotherapy', 'Hypofractionated Versus Standard Fractionated Radiotherapy', 'hypofractionated radiotherapy']","['9-year risk of locoregional recurrence', '9-year overall survival', 'risk of induration', 'occurrence of radiation-associated cardiac and lung disease', 'occurrence of breast induration', 'cosmetic outcome and patient satisfaction with breast appearance', '9-year locoregional recurrence risk', '3-year grade 2-3 breast induration assuming noninferiority regarding locoregional recurrence', 'Telangiectasia, dyspigmentation, scar appearance, edema, and pain', '3-year rates of induration']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191378', 'cui_str': '917'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0269268', 'cui_str': 'Induration of breast'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C1260926', 'cui_str': 'Abnormal pigmentation'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",917.0,0.225583,Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy.,"[{'ForeName': 'Birgitte V', 'Initials': 'BV', 'LastName': 'Offersen', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alsner', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hanne M', 'Initials': 'HM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Mette H', 'Initials': 'MH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Radiation Oncology and OncoRay Center, University Hospital and Faculty of Medicine Carl Gustav Carus; Technische Universität Dresden; German Cancer Consortium Dresden; Helmholtz-Zentrum Dresden-Rossendorf; National Center for Tumor Diseases, Dresden; and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Stenbygaard', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ingvil', 'Initials': 'I', 'LastName': 'Mjaaland', 'Affiliation': 'Department of Oncology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schreiber', 'Affiliation': 'Department of Oncology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany.'}, {'ForeName': 'Unn-Miriam', 'Initials': 'UM', 'LastName': 'Kasti', 'Affiliation': 'Department of Oncology, Kristiansand Hospital, Kristiansand, Norway.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Overgaard', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01363']
2649,32906032,The MUC5B promoter variant does not predict progression of interstitial lung disease in systemic sclerosis.,"OBJECTIVE


To investigate the prevalence of the MUC5B promoter variant rs35705950 in patients with systemic sclerosis-interstitial lung disease (SSc-ILD) and whether its presence predicts response to immunosuppression with cyclophosphamide (CYC) and mycophenolate (MMF).
METHODS


SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N = 142). TaqMan Genotyping Assays were used to determine the MUC5B rs35705950 single nucleotide polymorphism. Joint models were created to examine how the presence of this variant affected the course of the forced vital capacity (FVC) over 2 years. Linear regression models were used to investigate the relationship between the presence of this variant and the change in quantitative radiographic fibrosis.
RESULTS


Among 128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele. Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%). The presence of the MUC5B variant did not affect the course of the FVC, nor the change in quantitative radiographic fibrosis, ground glass or ILD scores in either treatment arm.
CONCLUSION


In the context of a randomized controlled trial for SSc-ILD, the presence of the MUC5B variant did not predict disease severity, nor affect treatment response to MMF or CYC. Future studies are needed to determine whether this variant affects ILD progression in other SSc cohorts and in patients receiving anti-fibrotic therapy.",2020,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","['patients with systemic sclerosis-interstitial lung disease (SSc-ILD', '128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele', 'SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N\u202f=\u202f142']","['MUC5B promoter variant rs35705950', 'cyclophosphamide (CYC) and mycophenolate (MMF']","['quantitative radiographic fibrosis, ground glass or ILD scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0532196,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA. Electronic address: evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA; Department of Biostatistics, University of California, Los Angeles, Fielding School of Public Health Los Angeles, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Pourzand', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA; Department of Medicine, University of Washington, Seattle, USA; Department of Rheumatology, University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'Department of Biomathematics, University of California, Los Angeles, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.003']
2650,32906135,Tubular Biomarkers and Chronic Kidney Disease Progression in SPRINT Participants.,"BACKGROUND


Kidney tubular atrophy on biopsy is a strong predictor of chronic kidney disease (CKD) progression, but tubular health is poorly quantified by traditional measures including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of impaired tubule function would be associated with faster eGFR declines in persons with CKD.
METHODS


We measured baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m) among 2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2. We used linear mixed models to evaluate biomarker associations with annualized relative change in eGFR, stratified by randomization arm.
RESULTS


At baseline, the mean age was 73 ± 9 years and eGFR was 46 ± 11 mL/min/1.73 m2. In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10 [95% CI: -0.18, -0.02]) in multivariable-adjusted models including baseline eGFR and albuminuria. Associations were weaker and did not reach statistical significance in the intensive blood pressure treatment arm for either uromodulin (0.11 [-0.13, 0.35], p value for interaction by treatment arm = 0.045) or β2m (-0.01 [-0.08, 0.08], p value for interaction = 0.001). Urinary α1m was not independently associated with eGFR decline in the standard (0.01 [-0.22, 0.23]) or intensive (0.03 [-0.20, 0.25]) arm.
CONCLUSIONS


Among trial participants with hypertension and CKD, baseline measures of tubular function were associated with subsequent declines in kidney function, although these associations were diminished by intensive blood pressure control.",2020,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","['2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2', 'persons with CKD', 'SPRINT Participants']",[],"['baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m', 'Tubular Biomarkers and Chronic Kidney Disease Progression', 'annual eGFR decline', 'eGFR decline', 'intensive blood pressure control', 'kidney function', 'Urinary α1m', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",2428.0,0.0823971,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","[{'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Segal', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000509978']
2651,32912971,Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial.,"OBJECTIVE


To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.
DESIGN AND SETTING


A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015-August 2016).
PARTICIPANTS


Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.
INTERVENTION


Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.
OUTCOME MEASURES


The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.
RESULTS


325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.
CONCLUSIONS


A large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.
TRIAL REGISTRATION NUMBER


ISRCTN46661996.",2020,"No serious adverse events were attributable to oestrogen use.
","['325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible', 'Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment', 'six UK urogynaecology centres (July 2015-August 2016', 'women undergoing pelvic organ prolapse (POP) surgery', 'postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS']","['Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries', 'oestrogen treatment with no oestrogen supplementation', 'local oestrogen treatment', 'preoperative and postoperative oestrogen or no treatment']","['complete questionnaires', 'eligibility and recruitment rates along with compliance and data completion', 'serious adverse events']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0330839', 'cui_str': 'Lotus'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",325.0,0.223352,"No serious adverse events were attributable to oestrogen use.
","[{'ForeName': 'Tina Sara', 'Initials': 'TS', 'LastName': 'Verghese', 'Affiliation': 'Institute of Metabolism and System Research, University of Birmingham, Birmingham, UK t.s.verghese@bham.ac.uk.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Middleton', 'Affiliation': 'School of Health and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Leighton', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pallavi Manish', 'Initials': 'PM', 'LastName': 'Latthe', 'Affiliation': ""Obstetrics and Gynaecology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025141']
2652,32912974,Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression.,"INTRODUCTION


Cardiac rehabilitation (CR) is offered to reduce the risk of further cardiac events and to improve patients' health and quality of life following a cardiac event. Psychological care is a common component of CR as symptoms of depression and/or anxiety are more prevalent in this population, however evidence for the cost-effectiveness of current interventions is limited. Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients. This protocol describes the planned approach to the economic evaluation of MCT for CR patients.
METHODS AND ANALYSIS


The economic evaluation work will consist of a within-trial analysis and an economic model. The PATHWAY Group MCT study has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomised controlled trial study design (UK Clinical Trials Gateway). A within-trial economic evaluation and economic model will compare the cost-effectiveness of MCT plus usual care (UC) to UC, from a health and social care perspective in the UK. The within-trial analysis will use intention-to-treat and estimate total costs and quality-adjusted life-years (QALYs) for the trial follow-up. Single imputation will be used to impute missing baseline variables. Multiple imputation will be used to impute values missing at follow-up. Items of resource use will be multiplied by published national healthcare costs. Regression analysis will be used to estimate net costs and net QALYs and these estimates will be bootstrapped to generate 10 000 net pairs of costs and QALYs to inform the probability of cost-effectiveness. A decision analytical economic model will be developed to synthesise trial data with the published literature over a longer time frame. Sensitivity analysis will explore uncertainty. Guidance of the methods for economic models will be followed and dissemination will adhere to reporting guidelines.
ETHICS AND DISSEMINATION


The economic evaluation includes a within-trial analysis. The trial which included the collection of this data was reviewed and approved by Ethics. Ethics approval was obtained by the Preston Research Ethics Committee (project ID 156862). The modelling analysis is not applicable for Ethics as it will use data from the trial (secondary analysis) and the published literature. Results of the main trial and economic evaluation will be published in the peer-reviewed National Institute for Health Research (NIHR) journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
TRIAL REGISTRATION NUMBER


ISRCTN74643496; Pre-results.",2020,"Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients.",['cardiac rehabilitation participants with symptoms of anxiety and/or depression'],"['MCT plus usual care (UC) to UC', 'Metacognitive therapy (MCT', 'metacognitive therapy', 'Cardiac rehabilitation (CR']",['total costs and quality-adjusted life-years (QALYs'],"[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.156245,"Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients.","[{'ForeName': 'Gemma E', 'Initials': 'GE', 'LastName': 'Shields', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK gemma.shields@manchester.ac.uk.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'Faculty of Biology, Medicine and Health, School of Psychological Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'Centre for Primary Care, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Capobianco', 'Affiliation': 'Research & Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Heagerty', 'Affiliation': 'Institute of Cardiovascular Sciences, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Buck', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Davies', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035552']
2653,32912977,Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study.,"INTRODUCTION


Major depression (MD) often has its onset during adolescence and is associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation and the underlying neural processes. Cognitive reappraisal (CR) is a particular adaptive emotion regulation strategy. Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. Specifically, we will investigate whether the CR training improves the ability to downregulate negative affect in MD individuals as assessed by behavioural and neurobiological indices, and whether training effects generalise outside the laboratory.
METHODS AND ANALYSIS


Adolescents with MD will be randomly allocated to a group that either receives a task-based training in CR or a control training. Both involve four training sessions over a time period of 2 weeks. In the CR training, participants will be instructed to downregulate negative affective responses to negative pictures via CR, while the control training involves picture viewing. During the training sessions, the Late Positive Potential, gaze fixations on negative picture aspects and affective responses to pictures will be collected. Before and after the training programmes, and at a 2-week follow-up, overall negative and positive affect, rumination and perceived stress will be assessed as primary outcomes. Analyses of variance will be conducted to test the effectiveness of the CR training with regard to both primary outcomes and task-based behavioural and neurobiological parameters.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of the Medical Faculty of the LMU Munich, Germany. The results will be published in peer-reviewed journals and disseminated through conferences, social media and public events.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov NCT03957850, registered 21 st  May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850.",2020,"Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.","['Adolescents with MD', 'adolescents with major depression', 'registered 21 st  May 2019', 'MD adolescents', 'healthy adults']","['Cognitive reappraisal (CR', 'emotion regulation training', 'CR training', 'task-based training in CR', 'task-based training in CR or a control training']","['Late Positive Potential, gaze fixations on negative picture aspects and affective responses']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",,0.0982554,"Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany Ellen.Greimel@med.uni-muenchen.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Feldmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Piechaczek', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Oort', 'Affiliation': 'Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bartling', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schulte-Rüther', 'Affiliation': 'Translational Brain Medicine in Psychiatry and Neurology, Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Schulte-Körne', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-036093']
2654,32912978,Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial.,"OBJECTIVES


To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).
DESIGN


Multicentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statistical comparison was performed between the two study groups.
SETTING


Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK.
PARTICIPANTS


Our aim was to recruit 50 patients with TBI over 18 months. Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
RESULTS


Six participants were randomised to the active arm of the trial and eight to the placebo arm over a 10-month period (28% of our target). Two participants withdrew because of adverse events. Twelve out of 14 (85.7%) patients completed a follow-up assessment at 12 weeks. At follow-up, the scores of all outcome measures improved in both groups. Placebo group showed numerically better score change according to the primary outcome MOAS. No severe adverse events were reported. The overall rate of adverse events remained low. Data from the process evaluation suggest that existence of specialised TBI follow-up clinics, availability of a dedicated database of TBI patients' clinical details, simple study procedures and regular support to participants would enhance recruitment and retention in the trial. Feedback from participants showed that once in the study, they did not find the trial procedure onerous.
CONCLUSIONS


It was not feasible to conduct a successful randomised trial of risperidone versus placebo for post-TBI aggression using the methods we deployed in this study. It is not possible to draw any definitive conclusion about risperidone's efficacy from such a small trial.
TRIAL REGISTRATION NUMBER


ISRCTN30191436.",2020,"Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
","['50 patients with TBI over 18 months', 'adults with traumatic brain injury (TBI', 'Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK', 'Six participants', 'traumatic brain injury']","['placebo', 'Risperidone', 'risperidone', 'risperidone versus placebo', 'Placebo']","['severe adverse events', 'aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser', 'overall rate of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0454861', 'cui_str': 'Kent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.665328,"Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
","[{'ForeName': 'Shoumitro', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK s.deb@imperial.ac.uk.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aimola', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Leeson', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Bodani', 'Affiliation': 'Kent and Medway NHS and Social Care Partnership NHS Trust, Maidstone, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sharp', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036300']
2655,32915892,"Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study.","BACKGROUND


Beta-blockers are often not the preferred treatment for patients with vasospastic angina. However, nebivolol, beta-blocker with nitric oxide-releasing effect, could theoretically improve coronary vasospasm. We compared nebivolol versus diltiazem in improving coronary vasospasm and quality of life in patients with hypertensive vasospastic angina during a 12-week follow-up.
METHODS


Fifty-one hypertensive patients with documented coronary vasospasm were randomly allocated into 3 treatment groups: (1) Nebivolol Group (5mg for 2 weeks/10mg for 10 weeks); (2) Diltiazem Group (90mg for 2 weeks/180mg for 10 weeks); (3) Low-dose Combination Group (2.5mg + 45mg for 2 weeks/5mg + 90mg for 10 weeks). The primary endpoint was to compare the percent changes in coronary vasospasm at 12 weeks from baseline among the 3 groups. The secondary endpoints included changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure at 12 weeks from baseline.
RESULTS


Significant improvements in coronary vasospasm were found in all groups; however, the improvement in percent changes in coronary artery spasm was greatest in the Diltiazem Group (50.4±8.8% vs. 67.8±12.8% vs. 46.8±12.3%, Nebivolol Group vs. Diltiazem Group p = 0.008; Nebivolol Group vs. Low-dose Combination Group p = 0.999; Diltiazem Group vs. Low-dose Combination Group p = 0.017). The overall Seattle Angina Questionnaire scores were significantly elevated at 12 weeks compared to the baseline in entire study population. There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
CONCLUSIONS


Both nebivolol and diltiazem showed significant coronary vasospasm reduction effect, but the effect was greater for diltiazem.",2020,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","['Fifty-one hypertensive patients with documented coronary vasospasm', 'patients with hypertensive vasospastic angina during a 12-week follow-up', 'patients with hypertension and vasospastic angina', 'patients with vasospastic angina']","['diltiazem', 'Diltiazem', 'nebivolol', 'Nebivolol', 'nebivolol and diltiazem']","['changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure', 'overall Seattle Angina Questionnaire score changes and blood pressure changes', 'coronary vasospasm', 'coronary artery spasm and quality of life', 'coronary vasospasm and quality of life', 'coronary vasospasm reduction effect', 'overall Seattle Angina Questionnaire scores', 'coronary artery spasm']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",51.0,0.050534,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","[{'ForeName': 'Hyungdon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Sook', 'Initials': 'KS', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sunki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239039']
2656,32915904,Automated vessel density detection in fluorescein angiography images correlates with vision in proliferative diabetic retinopathy.,"PURPOSE


To investigate the correlation between quantifiable vessel density, computed in an automated fashion, from ultra-widefield fluorescein angiography (UWFFA) images from patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness.
METHODS


We performed a secondary analysis of a prospective randomized controlled trial. We designed and trained an algorithm to automate retinal vessel detection from input UWFFA images. We then used our algorithm to study the correlation between baseline vessel density and best corrected visual acuity (BCVA) and CRT for patients in the RECOVERY study. Reliability of the algorithm was tested using the intraclass correlation (ICC). 42 patients from the Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study. These patients had PDR without significant center-involving diabetic macular edema (central retinal thickness [CRT] ≤320μm).
RESULTS


Our algorithm analyzed UWFFA images with a reliability measure (ICC) of 0.98. A positive correlation (r = 0.4071, p = 0.0075) was found between vessel density and BCVA. No correlation was found between vessel density and CRT.
CONCLUSIONS


Our algorithm is capable of reliably quantifying vessel density in an automated fashion from baseline UWFFA images. We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
TRANSLATIONAL RELEVANCE


Our work is the first to offer an algorithm capable of quantifying vessel density in an automated fashion from UWFFA images, allowing us to work toward studying the relationship between retinal vascular changes and important clinical endpoints, including visual acuity, in ischemic eye diseases.",2020,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","['proliferative diabetic retinopathy', 'Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study', '42 patients from the', 'patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness']","['ultra-widefield fluorescein angiography (UWFFA) images', 'Intravitreal Aflibercept']","['vessel density and BCVA', 'vessel density and CRT', 'baseline vessel density and best corrected visual acuity (BCVA', 'diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]",42.0,0.0724223,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bawany', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Ramchandran', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, United States of America.'}, {'ForeName': 'Ajay E', 'Initials': 'AE', 'LastName': 'Kuriyan', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0238958']
2657,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
2658,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
2659,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
2660,32897569,Rituximab and glatiramer acetate in secondary progressive multiple sclerosis: A randomized clinical trial.,"BACKGROUND


Treatment options for secondary progressive multiple sclerosis (SPMS) are limitedly investigated. We aimed to compare the efficacy of rituximab (RTX) and glatiramer acetate (GA) in SPMS patients.
METHOD


This open, randomized clinical trial was conducted on 84 SPMS patients, assigned to receive RTX or GA for 12 months. In RTX group, patients received 1 g intravenous RTX primarily and then every 6-months. In GA group, patients received 40 mg of GA 3-times/week subcutaneously. We measured EDSS as the primary outcome and neuroimaging findings, relapse rate (RR), and side effects as the secondary outcomes.
RESULTS


Seventy-three patients completed the study (37 and 36 in RTX and GA groups, respectively). The mean EDSS increased from 3.05 ± 1.01 to 4.14 ± 0.91 in RTX group (p < 0.001) and from 3.22 ± 1.20 to 4.60 ± 0.67 in GA group (p < 0.001). No statistically significant difference was observed in EDSS between two groups (F(1, 67) = 3.377; p = 0.071). The number of active lesions in brain and cervical spine decreased with no difference between groups (p > 0.05). Also, RR decreased in both groups without significant difference between them (F(1, 67) = 0.390; p = 0.534). Non-serious complications were observed in both groups.
CONCLUSION


Neither RTX nor GA affects EDSS in SPMS patients. They are equally effective in the relapse control of these patients.",2020,The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05).,"['84 SPMS patients', 'SPMS patients', 'secondary-progressive multiple sclerosis', 'secondary progressive multiple sclerosis (SPMS']","['Rituximab and glatiramer-acetate', 'rituximab (RTX) and Glatiramer acetate (GA', 'RTX or GA']","['number of active lesions in brain and cervical spine', 'mean EDSS', 'RR', 'neuroimaging findings, relapse rate (RR) and side-effects', 'EDSS']","[{'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.0658166,The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Cheshmavar', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Mirmosayyeb', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Badihian', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Badihian', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Shaygannejad', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Acta neurologica Scandinavica,['10.1111/ane.13344']
2661,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
2662,32899723,Early Loading of Mandibular Molar Single Implants: 1 Year Results of a Randomized Controlled Clinical Trial.,"The purpose of this study was to compare the implant survival, peri-implant marginal bone level, and peri-implant soft tissue of three different types of implants. This was performed with an early loading protocol, using a complete digital workflow, for one year of follow-up. Twenty-four patients with a single missing tooth in the mandibular posterior region were randomly assigned to the control group (SLActive Bone level implant; Institut Straumann AG, Basel, Switzerland), experiment group 1 (CMI IS-III Active implant; Neobiotech Co., Seoul, Korea), and experiment group 2 (CMI IS-III HActive implant; Neobiotech Co., Seoul, Korea). For each patient, a single implant was installed using the surgical template, and all prostheses were fabricated using a computer-aided design/computer-aided manufacturing system on a 3-dimensional model. A provisional prosthesis was implanted at 4 weeks, and a definitive monolithic zirconia prosthesis was substituted 12 weeks following the implant placement. The implant stability quotient (ISQ) and peri-implant soft tissue parameters were measured, and periapical radiographs were taken at 1, 3, 4, 8, 12, 24, 36, and 48 weeks after implant placements. Seven implants in the control group, nine implants in the experiment 1 group, and eight implants in the experiment 2 group were analyzed. There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05). Statistically significant differences in ISQ values were observed between the control and experiment 1 groups, and the control and experiment 2 groups at the 12 to 48 weeks' follow-ups. Within the limits of this prospective study, an early loading protocol can be applied as a predictable treatment modality in posterior mandibular single missing restorations, achieving proper primary stability.",2020,"There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05).",['Twenty-four patients with a single missing tooth in the mandibular posterior region'],"['control group (SLActive Bone level implant; Institut Straumann AG, Basel, Switzerland), experiment group 1 (CMI IS-III Active implant; Neobiotech Co., Seoul, Korea), and experiment group 2 (CMI IS-III', 'Mandibular Molar Single Implants']","['ISQ values', 'marginal bone loss', 'implant stability quotient (ISQ) and peri-implant soft tissue parameters', 'implant survival, peri-implant marginal bone level', 'insertion torque, ISQ values']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",24.0,0.0369916,"There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05).","[{'ForeName': 'Jungwon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Department of Prosthodontics and Dental Research Institute, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Bongju', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Dental Life Science Research Institute & Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Ki-Tae', 'Initials': 'KT', 'LastName': 'Koo', 'Affiliation': 'Department of Periodontology and Dental Research Institute, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13183912']
2663,32899902,Effect of Passive Stretching of Respiratory Muscles on Chest Expansion and 6-Minute Walk Distance in COPD Patients.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Hyperinflation of the lungs leads to a remodeling of the inspiratory muscles that causes postural deformities and more labored breathing. Postural changes include elevated, protracted, or abducted scapulae with medially rotated humerus, and kyphosis that leads to further tightening of respiratory muscles. As the severity of the disease progresses, use of the upper limbs for functional tasks becomes difficult due to muscle stiffness. There are various studies that suggest different rehabilitation programs for COPD patients; however, to the best of our knowledge none recommends passive stretching techniques. The aim of this study was to assess the effect of respiratory muscle passive stretching on chest expansion and 6-min walk distance (6MWD) in patients with moderate to severe COPD.
METHODS


Thirty patients were divided into two groups, experimental ( n  = 15) and control ( n  = 15). The experimental group received a hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints. The control group received a hot pack followed by relaxed passive movements of the shoulder joints.
RESULTS


In the control group, there was no difference in chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD between baseline and post treatment ( p  > 0.05). In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05). A comparison between control and experimental groups showed that chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.01) were significantly higher in the experimental group, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).
CONCLUSIONS


Although COPD is an irreversible disease, results of this study indicate that passive stretching of respiratory muscles can clinically improve the condition of such patients, especially in terms of chest expansion and 6MWD. Given the good effects of muscle stretching and the fact that such an exercise is harmless, clinicians and physiotherapists should consider including passive stretching of respiratory muscles in the rehabilitation plan of COPD patients.",2020,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","['COPD patients', 'Chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'COPD Patients', 'Thirty patients']","['Passive Stretching of Respiratory Muscles', 'hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints', 'respiratory muscle passive stretching', 'hot pack followed by relaxed passive movements of the shoulder joints']","['chest expansion', 'chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD', 'chest expansion and 6-min walk distance (6MWD', 'Chest Expansion and 6-Minute Walk Distance', '6MWD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]","[{'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0043356', 'cui_str': 'Structure of xiphoid process of sternum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",30.0,0.0204537,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Al Hosn One Day Surgery Center LLC, Al Sahel Tower Building, Post Box 37384, Abu Dhabi, UAE.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Ganai', 'Affiliation': 'Department of Rehabilitation Sciences, Jamia Hamdard, New Delhi 110062, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Neuro-Physiotherapy Unit, NSC, All India Institute of Medical Sciences, New Delhi 110029, India.'}, {'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Zaheen A', 'Initials': 'ZA', 'LastName': 'Iqbal', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186480']
2664,32902352,Symmetric interlimb transfer of newly acquired skilled movements.,"In this study, we aimed to examine features of interlimb generalization or ""transfer"" of newly acquired motor skills, with a broader goal of better understanding the mechanisms mediating skill learning. Right-handed participants ( n  = 36) learned a motor task that required them to make very rapid but accurate reaches to one of eight randomly presented targets, thus bettering the typical speed-accuracy tradeoff. Subjects were divided into an ""RL"" group that first trained with the right arm and was then tested on the left and an ""LR"" group that trained with the left arm and was subsequently tested on the right. We found significant interlimb transfer in both groups. Remarkably, we also observed that participants learned faster with their left arm compared with the right. We hypothesized that this could be due to a previously suggested left arm/right hemisphere advantage for movements under variable task conditions. To corroborate this, we recruited two additional groups of participants ( n  = 22) that practiced the same task under a single target condition. This removal of task level variability eliminated learning rate differences between the arms, yet interlimb transfer remained robust and symmetric, as in the first experiment. Additionally, the strategy used to reduce errors during learning, albeit heterogeneous across subjects particularly in our second experiment, was adopted by the untrained arm. These findings may be best explained as the outcome of the operation of cognitive strategies during the early stages of motor skill learning. NEW & NOTEWORTHY  How newly acquired motor skills generalize across effectors is not well understood. Here, we show that newly learned skilled actions transfer symmetrically across the arms and that task-level variability influences learning rate but not transfer magnitude or direction. Interestingly, strategies developed during learning with one arm transfer to the untrained arm. This likely reflects the outcome of learning driven by cognitive mechanisms during the initial stages of motor skill acquisition.",2020,"This removal of task level variability eliminated learning rate differences between the arms, yet, interlimb transfer remained robust and symmetric, as in the first experiment.",['two additional groups of participants (n=22) that practiced the same task under a single target condition'],"['RL', 'interlimb generalization or ""transfer"" of newly acquired motor skills']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",[],,0.0202815,"This removal of task level variability eliminated learning rate differences between the arms, yet, interlimb transfer remained robust and symmetric, as in the first experiment.","[{'ForeName': 'Goldy', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Center for Cognitive and Brain Sciences, Indian Institute of Technology Gandhinagar, Gujarat, India.'}, {'ForeName': 'Pratik K', 'Initials': 'PK', 'LastName': 'Mutha', 'Affiliation': 'Center for Cognitive and Brain Sciences, Indian Institute of Technology Gandhinagar, Gujarat, India.'}]",Journal of neurophysiology,['10.1152/jn.00777.2019']
2665,32906606,Effects of Topical Prostaglandin Analog on Macular Thickness Following Cataract Surgery with Postoperative Topical Bromfenac Treatment.,"PURPOSE


To evaluate changes in macular thickness in patients continuing prostaglandin analog (PGA) treatment during the perioperative period involving bromfenac treatment.
METHODS


Patients with glaucoma who were using a topical PGA were randomly assigned to two groups in this randomized controlled trial: PGA continuing study group and PGA discontinued glaucoma control group. Patients without ocular diseases other than cataract were enrolled into the non-glaucomatous group. After the cataract surgery, the patients used bromfenac twice per day for 4 weeks. Optical coherence tomography was performed in all patients preoperatively and at 1 month postoperatively. Changes in macular thickness were compared among the three groups.
RESULTS


There were 32 eyes in the study group, 33 eyes in the glaucoma control group, and 58 eyes in the non-glaucomatous group. We found statistically significant postoperative changes in central macular thickness in all groups (4.30 ± 8.01 μm in the PGA continuing group, 9.20 ± 13.88 μm in the PGA discontinued group, and 7.06 ± 7.02 μm in the non-glaucomatous group, all  p  < 0.008), but no significant difference among the three groups ( p  = 0.161). Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
CONCLUSIONS


Continuous use of PGAs during the perioperative period was not significantly associated with increased macular thickness after uncomplicated cataract surgery. In the absence of other risk factors (e.g., capsular rupture, uveitis, or diabetic retinopathy), discontinuing PGAs for the prevention of macular edema after cataract surgery with postoperative bromfenac treatment is unnecessary in patients with glaucoma.",2020,"Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
","['32 eyes in the study group, 33 eyes in the glaucoma control group, and 58 eyes in the non-glaucomatous group', 'Patients without ocular diseases other than cataract were enrolled into the non-glaucomatous group', 'patients with glaucoma', 'Macular Thickness Following Cataract Surgery with Postoperative Topical Bromfenac Treatment', 'patients continuing prostaglandin analog (PGA) treatment during the perioperative period involving bromfenac treatment', 'Patients with glaucoma who were using a topical PGA']","['PGA discontinued glaucoma control group', 'Topical Prostaglandin Analog', 'Optical coherence tomography']","['macular thickness', 'Cystoid macular edema', 'central macular thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",,0.0216944,"Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
","[{'ForeName': 'Kee Sup', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Kyoung Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Kyeung Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Han Min', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Sung Bok', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Nam Ho', 'Initials': 'NH', 'LastName': 'Lee', 'Affiliation': 'Mindeulle Eye Clinic, 9 Samsannam-ro, Boeun 28950, Korea.'}, {'ForeName': 'Chang-Sik', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9092883']
2666,32906673,Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention.,"In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, an early invasive strategy did not decrease mortality compared to a conservative strategy for stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia, and the role of revascularization would be revised. However, the applicability and potential influence of this trial in daily practice remains unclear. Our objective was to assess the eligibility and representativeness of the ISCHEMIA trial on the patients with percutaneous coronary intervention (PCI). From a multicenter registry, we extracted a consecutive 13,223 SIHD patients with PCI (baseline cohort). We applied ISCHEMIA eligibility criteria and compared the baseline characteristics between the eligible patients and the actual study participants (randomized controlled trial (RCT) patients). In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry. In the baseline cohort, 77.3% of SIHD patients with moderate-to-severe ischemia were eligible for the ISCHEMIA. They were comparable with RCT patients for baseline characteristics and outcomes unlike the non-eligible patients. In conclusion, the trial results seem applicable for the majority of PCI patients with moderate-to-severe ischemia except for the non-eligible patients.",2020,"In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry.","['patients with percutaneous coronary intervention (PCI', 'stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia', '13,223 SIHD patients with PCI (baseline cohort', '3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry', 'SIHD patients with moderate-to-severe ischemia', 'Patients who Underwent Revascularization with Percutaneous Coronary Intervention']","['RCT', 'Medical and Invasive Approaches (ISCHEMIA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",[],3463.0,0.0871434,"In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry.","[{'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Niimi', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Sawano', 'Affiliation': 'Department of Cardiology, Tokyo Dental College Ichikawa General Hospital, Chiba Prefecture 272-8513, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Ikemura', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo 060-8638, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Cardiology, Saitama Medical University, International Medical Center, Saitama Prefecture 350-1298, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shoji', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Numasawa', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Tochigi Prefecture 326-0843, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, National Hospital Organization Saitama Hospital, Saitama Prefecture 351-0102, Japan.'}, {'ForeName': 'Shigetaka', 'Initials': 'S', 'LastName': 'Noma', 'Affiliation': 'Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi Prefecture 321-0974, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9092889']
2667,32910197,Effect of Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells in Patients With Chronic Ischemic Heart Disease: A Randomized Clinical Trial.,"Importance


Cell therapy may be helpful for cardiac disease but has been fraught with poor cell retention and survival after transplantation.
Objective


To determine whether cell-laden hydrogel treatment is safe and feasible for patients with chronic ischemic heart disease (CIHD).
Design, Setting, and Participants


This randomized, double-blind clinical trial was conducted between March 1, 2016, and August 31, 2019, at a single hospital in Nanjing, China. Among 115 eligible patients with CIHD, 50 patients with left ventricular ejection fraction of 45% or less were selected to receive elective coronary artery bypass grafting (CABG) and additionally randomized to cell-plus-collagen treatment (collagen/cell group), cell treatment alone (cell group), or a control group. Sixty-five patients were excluded because of severe comorbidities or unwillingness to participate. Forty-four participants (88%) completed the study. The last patient completed 12 months of follow-up in August 2019. Analyses were prespecified and included all patients with available data.
Interventions


During CABG, patients in the collagen/cell group were treated with human umbilical cord-derived mesenchymal stromal cell (hUC-MSC)-laden collagen hydrogel intramyocardial injection, and the cell group was treated with hUC-MSCs alone. Patients in the control group underwent CABG alone.
Main Outcomes and Measures


The primary outcome was safety of the cell-laden collagen hydrogel assessed by the incidence of serious adverse events. The secondary end point was the efficacy of treatment, according to cardiovascular magnetic resonance imaging-based left ventricular ejection fraction and infarct size.
Results


Fifty patients (mean [SD] age, 62.6 [8.3] years; 38 men [76%]) were enrolled, of whom 18 were randomized to the collagen/cell group, 17 to the cell group, and 15 to the control group. Patient characteristics did not differ among groups at baseline. For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group. At 12 months after treatment, the mean infarct size percentage change was -3.1% (95% CI, -6.20% to -0.02%; P = .05) in the collagen/cell group, 5.19% (-1.85% to 12.22%, P = .35) in the cell group, and 8.59% (-3.06% to 20.25%, P = .21) in the control group.
Conclusions and Relevance


This study provides, to our knowledge, the first clinical evidence that the use of collagen hydrogel is safe and feasible for cell delivery. These findings provide a basis for larger clinical studies.
Trial Registration


ClinicalTrials.gov Identifier: NCT02635464.",2020,"For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group.","['With Chronic Ischemic Heart Disease', 'patients with chronic ischemic heart disease (CIHD', 'Sixty-five patients were excluded because of severe comorbidities or unwillingness to participate', '115 eligible patients with CIHD, 50 patients with left ventricular ejection fraction of 45% or less were selected to receive', 'Patients', 'Fifty patients (mean [SD] age, 62.6 [8.3] years; 38 men [76', 'Forty-four participants (88%) completed the study', 'March 1, 2016, and August 31, 2019, at a single hospital in Nanjing, China']","['cell-laden hydrogel treatment', 'human umbilical cord-derived mesenchymal stromal cell (hUC-MSC)-laden collagen hydrogel intramyocardial injection', 'cell-plus-collagen treatment (collagen/cell group), cell treatment alone (cell group), or a control group', 'collagen hydrogel', 'elective coronary artery bypass grafting (CABG', 'Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells', 'CABG alone', 'hUC-MSCs alone']","['efficacy of treatment, according to cardiovascular magnetic resonance imaging-based left ventricular ejection fraction and infarct size', 'safety of the cell-laden collagen hydrogel assessed by the incidence of serious adverse events', 'hospitalization because of heart failure, and no serious adverse events', 'mean infarct size percentage change', 'serious adverse events, myocardial damage markers, and renal or liver function']","[{'cui': 'C0264694', 'cui_str': 'Chronic myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",50.0,0.116717,"For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group.","[{'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Center for Clinical Stem Cell Research, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Liudi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Center for Clinical Stem Cell Research, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dongjin', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16236']
2668,32912942,"Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study).","INTRODUCTION


Peanut allergy is the the most common cause of life-threatening food-induced anaphylaxis. There is currently no effective long-term treatment. There is a pressing need for definitive treatments that improve the quality of life and prevent fatalities. Allergen oral immunotherapy (OIT) is a promising approach, which is effective at inducing desensitisation; however, OIT has a limited ability to induce sustained unresponsiveness (SU). We have previously shown that a novel treatment comprising a combination of the probiotic  Lactobacillus rhamnosus  CGMCC 1.3724 with peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT)) is highly effective at inducing SU, with benefit persisting to 4 years after treatment cessation in the majority of initial treatment responders. Here we describe the protocol for a Phase IIb multicentre, double-blind, randomised, controlled trial (PPOIT-003) with dual primary objectives to evaluate the effectiveness of PPOIT at inducing SU (assessed at 8 weeks after treatment cessation) compared with placebo treatment and peanut OIT alone, in children with peanut allergy.
METHODS AND ANALYSIS


200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia. There are three intervention arms-PPOIT, peanut OIT alone or placebo. Interventions are administered once daily for 18 months. The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
ETHICS AND DISSEMINATION


This study has been approved by the Human Research Ethics Committees at the Royal Children's Hospital (HREC 35246) and the Child and Adolescent Health Service (RGS 2543). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences.
TRIAL REGISTRATION NUMBER


ACTRN12616000322437.",2020,"The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
","[""Royal Children's Hospital (HREC 35246) and the Child and Adolescent Health Service (RGS 2543"", '200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia', 'children with peanut allergy compared with oral immunotherapy (OIT) alone and with', 'children with peanut allergy']","['PPOIT at inducing SU', 'placebo treatment and peanut OIT alone', 'peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT', 'placebo', 'probiotic and peanut oral immunotherapy (PPOIT', 'Allergen oral immunotherapy (OIT']","['quality of life and prevent fatalities', 'proportion of children who attain 8-week SU']","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085100', 'cui_str': 'Health Services, Adolescent'}, {'cui': 'C3714873', 'cui_str': 'Axenfeld-Rieger Syndrome, Type 1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",,0.686388,"The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Chebar Lozinsky', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Loke', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'ORIGINS Project, Telethon Kids Institute, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'L Prescott', 'Affiliation': 'ORIGINS Project, Telethon Kids Institute, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gold', 'Affiliation': 'Paediatrics, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Quinn', 'Affiliation': 'Paediatrics, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Lk Tang', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia mimi.tang@rch.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035871']
2669,32912947,Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk.,"INTRODUCTION


Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.
METHODS AND ANALYSIS


Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCO M2012  (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.
ETHICS AND DISSEMINATION


The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.
TRIAL REGISTRATION NUMBERS


ISRCTN42704678 and NCT03750110.",2020,Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial.,"['ever-smokers aged 55-80 years registered with a general practice in Leeds', '62\u2009980 individuals']","['Low-dose computed tomography (LDCT) screening', 'invitation to community-based low-dose CT screening', 'telephone-based risk-assessment for a Lung Health Check or to usual care', 'LDCT scanning']","['health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies', 'participation rates, (2) compare the performance of PLCO M2012  (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes', 'lung cancer mortality']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0199175', 'cui_str': 'Preventive service'}, {'cui': 'C0162458', 'cui_str': 'Task Forces'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.101226,Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial.,"[{'ForeName': 'Philip Aj', 'Initials': 'PA', 'LastName': 'Crosbie', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Simmonds', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Rogerson', 'Affiliation': 'Department of Research and Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Department of Respiratory Medicine, City Campus, Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Lung Cancer and Thoracic Surgery Directorate, Heart and Lung Division, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Darby', 'Affiliation': 'Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Franks', 'Affiliation': 'Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Department of Respiratory Medicine, University College London, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Macleod', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Messenger', 'Affiliation': 'Leeds Centre for Personalised Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Moller', 'Affiliation': 'Thames Cancer Registry, Kings College London, London, UK.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology and Public Health, Faculty of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Neal', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Epidemiology and Public Health, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Puvanendran', 'Initials': 'P', 'LastName': 'Tharmanathan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew Ej', 'Initials': 'ME', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK matthew.callister@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2020-037075']
2670,32912948,Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme.,"INTRODUCTION


Integration of smoking cessation (SC) into lung cancer screening is essential to optimise clinical and cost effectiveness. The most effective way to use this 'teachable moment' is unclear. The Yorkshire Enhanced Stop Smoking study will measure the effectiveness of an SC service integrated within the Yorkshire Lung Screening Trial (YLST) and will test the efficacy of a personalised SC intervention, incorporating incidental findings detected on the low-dose CT scan performed as part of YLST.
METHODS AND ANALYSIS


Unless explicitly declined, all smokers enrolled in YLST will see an SC practitioner at baseline and receive SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette. Eligible smokers will be randomised (1:1 in permuted blocks of random size up to size 6) to receive either an enhanced, personalised SC support package, including CT scan images, or continued standard best practice. Anticipated recruitment is 1040 smokers (January 2019-December 2020). The primary objective is to measure 7-day point prevalent carbon monoxide (CO) validated SC after 3 months. Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. A process evaluation will explore under which circumstances and on which groups the intervention works best, test intervention fidelity and theory test the mechanisms of intervention impact.
ETHICS AND DISSEMINATION


This study has been approved by the East Midlands-Derby Research Ethics Committee (18/EM/0199) and the Health Research Authority/Health and Care Research Wales. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via the YLST website.
TRIAL REGISTRATION NUMBERS


ISRCTN63825779, NCT03750110.",2020,"Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points.","['1040 smokers (January 2019-December 2020', 'Eligible smokers']","['smoking cessation (SC', 'personalised smoking cessation intervention', 'Yorkshire Enhanced Stop Smoking']","['CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0385885,"Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points.","[{'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom rachael.murray@nottingham.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Harriet D', 'Initials': 'HD', 'LastName': 'Quinn-Scoggins', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'McCutchan', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ashurst', 'Affiliation': 'Department of Radiology, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Deaprtment of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Philip A J', 'Initials': 'PAJ', 'LastName': 'Crosbie', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Wythenshawe, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Neal', 'Affiliation': 'Institute of Health Science, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Rogerson', 'Affiliation': 'Research and Innivation CSU, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Thorley', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Matthew Ej', 'Initials': 'ME', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}]",BMJ open,['10.1136/bmjopen-2020-037086']
2671,32912951,East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol.,"INTRODUCTION


Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
METHODS AND ANALYSIS


In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.
ETHICS AND DISSEMINATION


This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER


NCT03670706.",2020,"The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
",['East Midlands knee pain'],['non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care'],[],"[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",[],,0.103226,"The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK michelle.hall@nottingham.ac.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fuller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Polykarpos Angelos', 'Initials': 'PA', 'LastName': 'Nomikos', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Millar', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Ogollah', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Valdes', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Greenhaff', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Academic Rheumatology, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Walsh', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037760']
2672,32912952,PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.,"BACKGROUND


Smoking is the primary preventable risk factor for disease and premature mortality. It is highly addictive and cessation attempts are often unsuccessful. Incentive-based programmes may be an effective method to reach sustained abstinence. Individualisation of incentives based on personal characteristics yields potential to further increase the effectiveness of incentive-based programmes.
METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme. The intervention under study is the provision of personalised incentives on validated smoking cessation at several time points after the smoking cessation programme. A total of 220 participants are required. Participants are randomised 1:1 into intervention (personalised incentives) or control (no incentives). All participants join the group-based programme. Incentives are provided on validated abstinence directly after the smoking cessation programme and after 3, 6 and 12 months.Incentives are provided according to four schemes:(1) Standard: total reward size €350, pay-out scheme: €50 (t=0), €50 (t=3 months), €50 (t=6 months) and €200 (t=12 months), (2) descending: total reward size €300, pay-out scheme: €150, €100, €50 and €0, (3) ascending: total reward size: €400, pay-out scheme: €0, €0, €50 and €350 and (4) deposit: total reward size €450, pay-out scheme: €50, €50, €150, €200; participants pay a €100 deposit, returned conditional on abstinence after 6 months.Advice on which incentive scheme suits participants best is based on willingness to provide a deposit, readiness to quit, nicotine dependency and long-term or short-term reward preference. Participants are free to deviate from this advice. Abstinence is validated at each time point, with 15 months of total follow-up. The primary end point is validated abstinence at 12 months. Effectiveness will be determined by intention-to-treat analysis.
ETHICS AND DISSEMINATION


The Erasmus MC Medical Ethics Committee decided that according to the Dutch Human Research Law (WMO), the protocol required no formal ethical approval. The results will be published in a peer-reviewed scientific journal and communicated to the participants.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register NL7711.",2020,"METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme.","['healthcare employees', '220 participants are required', 'healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme', '€50 (t=6 months) and €200 (t=12 months), (2) descending: total reward size €300, pay-out scheme: €150, €100, €50 and €0, (3) ascending: total reward size: €400, pay-out scheme: €0, €0, €50 and €350 and (4) deposit: total reward size €450, pay-out scheme: €50, €50, €150, €200; participants pay a €100 deposit, returned conditional on abstinence after 6 months']",['intervention (personalised incentives) or control (no incentives'],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],220.0,0.138195,"METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme.","[{'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Boderie', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes Lw', 'Initials': 'JL', 'LastName': 'van Kippersluis', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Diarmaid T', 'Initials': 'DT', 'LastName': 'Ó Ceallaigh', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Márta K', 'Initials': 'MK', 'LastName': 'Radó', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Burdorf', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'van Lenthe', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jasper V', 'Initials': 'JV', 'LastName': 'Been', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands j.been@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-037799']
2673,32928844,Investigation of predictors of interest in a brief mindfulness-based intervention and its effects in patients with psoriasis at a rehabilitation clinic (SkinMind): an observational study and randomised controlled trial.,"INTRODUCTION


Psoriasis (PS) is a chronic inflammatory skin disease accompanied by reduced quality of life. Mindfulness is the ability to focus on the present moment without evaluation. Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life. However, it remained unclear what distinguishes patients with PS interested in psychological interventions from those without interest and whether also a shorter, namely 2-week mindfulness-based intervention is beneficial in this patient group. This will be investigated with this study.
METHODS AND ANALYSES


Data will be collected at a rehabilitation clinic in Germany. The study is divided into two parts: study 1a is an observational study. Its aim is to investigate whether sociodemographic, skin-related and psychological factors are significant predictors of interest in a brief psychological intervention in 127 patients with PS. Study 1b is a randomised controlled trial, in which 60 patients (retrieved from study 1a) will be randomised to an intervention or control group (treatment as usual). The main outcome variables are mindfulness and self-compassion. In addition, mediation analyses will be used in an explorative manner to test whether there is a relationship between mindfulness/self-compassion and the severity of PS and whether it is mediated by itch catastrophising and fear of negative evaluation (first model) or perceived stress (second model).
ETHICS AND DISSEMINATION


The study protocol has been approved by the University of Giessen. Study results will be disseminated by publication of the results at (inter) national conferences and in scientific journals.
TRIAL REGISTRATION NUMBERS


DRKS00017426 and DRKS00017429.",2020,Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life.,"['60 patients (retrieved from study 1a', 'patients with psoriasis at a rehabilitation clinic (SkinMind', 'patients with PS', 'Data will be collected at a rehabilitation clinic in Germany', '127 patients with PS']",[],"['severity of the disease and quality of life', 'mindfulness and self-compassion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",127.0,0.0474813,Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stadtmüller', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eckardt', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zick', 'Affiliation': 'Department of Dermatology, Rehabilitation Clinic Borkum Riff, Borkum, Germany, Borkum, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Kupfer', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schut', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany Christina.Schut@mp.med.uni-giessen.de.'}]",BMJ open,['10.1136/bmjopen-2019-033952']
2674,32896184,"Remdesivir, a remedy or a ripple in severe COVID-19?","INTRODUCTION


In clinical trial for the Ebola virus, the broad-spectrum anti-viral agent remdesivir was shown to have a good safety profile. Remdesivir is now being tested in severe COVID-19.
AREAS COVERED


The Gilead Sciences SIMPLE trial suggests that the short-term use of remdesivir probably does not increase mortality dramatically or have serious short-term toxicity when used to treat severe COVID-19. The Adaptive COVID-19 treatment trials (ACTT1) trial showed that remdesivir may shorten recovery and decrease mortality in severe COVID-19 without increasing adverse effects.
EXPERT OPINION


It seems to me that we have learnt very little from the SIMPLE trial, and this would be predicted from a trial that has no control or placebo group. The results of ACTT1 were reported early after an interim analysis showed that a higher than expected number of recoveries had occurred. There was an indication that remdesivir may be reducing mortality, but this was no statistical significance. The trial is continuing, and the final data are eagerly awaited to determine whether remdesivir is a game-changing remedy or a ripple in the ongoing search for a medicine for the treatment of COVID-19.",2020,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155191,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1821645']
2675,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE


To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN


Prospective crossover study.
METHODS


Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS


Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS


Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
2676,32901323,Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis.,"INTRODUCTION


Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. The concept was adopted in other hospitals and published as a case series. This is the first prospectively controlled randomized study comparing DCS and conventional treatment (Group C) in this setting.
METHODS


All consecutive patients from 2013 to 2018 with indication for surgery were screened and randomized to Group DCS or Group C. The primary outcome was the rate of reconstructed bowel at discharge and at 6 month. Informed consent was obtained. The trial was approved by the local ethics committee and registered at CinicalTrials.gov: NCT04034407.
RESULTS


A total of 56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n = 14, 67%) or IV (n = 7, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10) were intraoperatively randomized and treated as Group DCS (n = 13) or Group C (n = 8). Per protocol analysis: A primary anastomosis without ileostomy (PA) was performed in 92% (11/12) patients in Group DCS at the second-look operation, one patient died before second look, and one underwent a Hartmann procedure (HP). In Group C 63% (5/8) patients received a PA and 38% (3/8) patients a HP. Two patients in Group C, but none in Group DCS experienced anastomotic leakage (AI). ICU and hospital stay was median (range) 2 (1-10) and 17.5 (12-43) in DCS and 2 (1-62) and 22 (13-65) days in group C. In Group DCS 8% (1/12) patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge. The odds ratio (95% confidence interval) for discharge with a stoma is 0.068 (0.005-0.861). Intent to treat analysis: A PA was performed in 90% (9/10) of patients randomized to DCS, one patient died before the second look, and one patient received a HP. In group C, 70% (7/10) were treated with PA and 30% (3/10) with HP. 29% (2/7) experienced AI treated with protective ileostomy. In group DCS, 9% (1/11) were discharged with a stoma versus 40% (4/10) in group C (p = 0.14, n.s.). The odds ratio for discharge with a stoma is 0.139 (0.012-1.608).
CONCLUSION


This is the first prospectively randomized controlled study showing that damage control surgery in perforated diverticulitis Hinchey III and IV enhances reconstruction of bowel continuity and can reduce the stoma rate at discharge.",2020,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","['Perforated Diverticulitis with Generalized Peritonitis', '56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n\u2009=\u200914, 67%) or IV (n\u2009=\u20097, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10', 'All consecutive patients from 2013 to 2018 with indication for surgery', 'patients with perforated diverticulitis and generalized peritonitis']","['DCS', 'Hartmann procedure (HP', 'Damage Control Surgery', 'HP', 'Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation', 'Group DCS', 'primary anastomosis without ileostomy (PA', 'Group DCS or Group C']","['rate of reconstructed bowel at discharge and at 6\xa0month', 'anastomotic leakage (AI', 'odds ratio for discharge with a stoma', 'ICU and hospital stay']","[{'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",56.0,0.0719085,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","[{'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kafka-Ritsch', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. reinhold.kafka-ritsch@tirol-kliniken.at.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Zitt', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perathoner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gasser', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kaufman', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Czipin', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aigner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Öfner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}]",World journal of surgery,['10.1007/s00268-020-05762-1']
2677,32902905,Improving Adherence to Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support.,"BACKGROUND


Adherence to weight-loss medication is suboptimal, leading to poor health outcomes. Short message service (SMS) can potentially improve adherence.
METHODS


A total of 3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites and were randomly assigned to receive none, three, or five SMS per week. Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian. Medication adherence was measured as whether the total scripts claimed were at least as many as the total claims expected by March 31, 2018, and was modeled adjusting for age, sex, baseline BMI, residential region, enrolment channel, the total number of SMS, and additional patient support.
RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week. The effectiveness of SMS on adherence decreased as participants received more SMS over time. Moreover, the odds of adhering to liraglutide were higher for participants enrolled with pharmacists compared with those enrolled with doctors (OR, 2.28; 95% CI: 1.82-2.86) and for participants who received a face-to-face consultation (OR, 3.10; 95% CI: 1.82-5.29) or a call (OR, 1.31; 95% CI: 1.02-1.68) compared with those who received no extra support.
CONCLUSIONS


Integration of SMS into routine clinical practice should consider not only the frequency and content of reminders but also additional patient support to achieve higher and more sustained adherence to medication and health behavior changes.",2020,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","['3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites', 'Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian']","['SMS', 'Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support', 'Short message service (SMS']","['odds of adhering to liraglutide', 'Medication adherence', 'adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3872102', 'cui_str': 'Saxenda'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",3994.0,0.116125,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","[{'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cunich', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fuller', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Purcell', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Allanah', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Caterson', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22930']
2678,32915043,The effects of cognitive processing therapy + hypnosis on objective sleep quality in women with posttraumatic stress disorder.,"Objective:  Insomnia, characterized by difficulty falling and staying asleep, is a common and debilitating symptom of posttraumatic stress disorder (PTSD) that is resistant to first-line, trauma-focused therapies. Previous research has found that sleep-directed hypnosis improves subjective sleep quality, particularly sleep onset latency, in women with PTSD. However, it cannot be assumed that improvements in subjective sleep reports correspond with objectively measured sleep improvements, because research has indicated a lack of agreement across these measures. The current study examined the effects of sleep-directed hypnosis plus cognitive processing therapy (hypCPT) on objective indices of sleep quality measured with actigraphy.  Method:  Forty-five women with PTSD were randomized to receive sleep-directed hypCPT or sleep and psychiatric symptom monitoring plus CPT (ssmCPT). Pre- and posttreatment, participants completed 1 week of daily actigraphy assessments of nocturnal sleep onset latency, waking after sleep onset, and total sleep time.  Results:  Overall improvement in objective sleep indices was not observed. Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  Conclusions:  More research is needed to understand and reduce the discrepancy between subjectively and objectively assessed sleep impairments in PTSD. Nevertheless, results indicate that adding sleep-directed hypnosis to trauma-focused therapy may be of some use for individuals with PTSD-related insomnia. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  ","['women with PTSD', 'individuals with PTSD-related insomnia', 'women with posttraumatic stress disorder', 'Method:  Forty-five women with PTSD']","['hypCPT', 'cognitive processing therapy + hypnosis', 'sleep-directed hypnosis plus cognitive processing therapy (hypCPT', 'sleep-directed hypCPT or sleep and psychiatric symptom monitoring plus CPT (ssmCPT']","['subjective sleep quality', 'time to fall asleep', 'objective sleep quality', 'objective sleep indices', 'sleep quality', 'nocturnal sleep onset latency, waking after sleep onset, and total sleep time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",45.0,0.0237354,"Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  ","[{'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Arditte Hall', 'Affiliation': 'Department of Psychology and Philosophy.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Werner', 'Affiliation': 'Missouri Institute of Mental Health.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Griffin', 'Affiliation': 'Center for Trauma Recovery.'}, {'ForeName': 'Tara E', 'Initials': 'TE', 'LastName': 'Galovski', 'Affiliation': 'VA National Center for PTSD.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000970']
2679,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
2680,32911210,Factors affecti̇ng health-promoting behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
2681,32911981,Permanent His Bundle Pacing Implantation Facilitated by Visualization of the Tricuspid Valve Annulus.,"BACKGROUND


His bundle pacing (HBP) is the most physiological pacing modality. However, HBP has longer procedure times with frequent high capture thresholds, which likely contributes to the low adoption of this approach. The aim of this study is to compare HBP implantation with a novel imaging technique versus the standard implantation technique.
METHODS


This study included 50 patients with standard pacing indications randomized to HBP with visualization of the tricuspid valve annulus (N=25, the visualization group) or with the standard method (N=25, the control group). In the visualization group, the tricuspid valve annulus was imaged by contrast injection in the right ventricle during fluoroscopy. The site for HBP was identified in relationship to the tricuspid septal leaflet and interventricular septum.
RESULTS


Permanent HBP was successful in 92% in the visualization group and 88% in the control group. The fluoroscopic time for HBP lead placement was significantly shorter in the visualization group (7.1±3.3 minutes) compared with the control group (10.1±5.6 minutes,  P =0.03). Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7 and 9.6±3.8 minutes) than the control group (104.4±17.8 and 12.7±6.2 minutes,  P =0.01 and 0.04, respectively). There was no significant difference in capture threshold between groups. In the visualization group, there was a quantitative association between the HBP site and the tricuspid valve annulus.
CONCLUSIONS


The visualization technique shortens the procedural and fluoroscopic times for HBP implantation. Moreover, anatomic localization of HBP sites is strongly associated with physiological characteristics of pacing, which can help guide optimal lead placement. Registration: URL: https://www.chictr.org.cn/index.aspx. Unique identifier: ChiCTR2000029834.",2020,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).",['50 patients with standard pacing indications randomized to'],"['HBP implantation with a novel imaging technique versus the standard implantation technique', 'TVA', 'His bundle pacing (HBP', 'HBP with visualization of the tricuspid valve annulus (TVA, N=25, the visualization group) or with the standard method', 'HBP']","['fluoroscopic time for HBP lead placement', 'Total procedural and fluoroscopic times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0225926', 'cui_str': 'Structure of anulus fibrosus of tricuspid orifice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",50.0,0.0224901,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Nixiao', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Minsi', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xuhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Cardiac Rhythm Heart Failure, Medtronic, plc, Minneapolis, MN (X.Z.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston (M.R.G.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008370']
2682,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable  MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE


For localized, resectable neuroblastoma without  MYCN  amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS


Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS


Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively;  P  = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively;  P  = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%,  P  = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%,  P  = .038).
CONCLUSION


Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
2683,32918135,Betaine and choline status modify the effects of folic acid and creatine supplementation on arsenic methylation in a randomized controlled trial of Bangladeshi adults.,"PURPOSE


Methylation of ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs) facilitates urinary arsenic elimination. Folate and creatine supplementation influenced arsenic methylation in a randomized controlled trial. Here, we examine if baseline status of one-carbon metabolism nutrients (folate, choline, betaine, and vitamin B 12 ) modified the effects of FA and creatine supplementation on changes in homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices.
METHODS


Study participants (N = 622) received 400 or 800 μg FA, 3 g creatine, 400 μg FA + 3 g creatine, or placebo daily for 12 weeks.
RESULTS


Relative to placebo, FA supplementation was associated with greater mean increases in %DMAs among participants with betaine concentrations below the median than those with levels above the median (FDR < 0.05). 400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03). Creatine treatment was associated with a significant decrease in %MMAs among participants with choline concentrations below the median (P = 0.04), but not among participants above the median (P = 0.94); this effect did not significantly differ between strata (P = 0.10).
CONCLUSIONS


Effects of FA and creatine supplementation on arsenic methylation capacity were greater among individuals with low betaine and choline status, respectively. The efficacy of FA and creatine interventions to facilitate arsenic methylation may be modified by choline and betaine nutritional status.
CLINICAL TRIAL REGISTRATION


Clinical Trial Registry Identifier: NCT01050556, U.S. National Library of Medicine, https://clinicaltrials.gov ; registered January 15, 2010.",2020,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","['Study participants (N\u2009=\u2009622) received', 'Bangladeshi adults']","['folic acid and creatine supplementation', 'FA and creatine interventions', 'Folate and creatine supplementation', 'placebo, FA supplementation', 'FA and creatine supplementation', '400 or 800\xa0μg FA, 3\xa0g creatine, 400\xa0μg FA\u2009+\u20093\xa0g creatine, or placebo', 'ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs']","['arsenic methylation', 'homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices', 'MMAs', 'homocysteine', 'arsenic methylation capacity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0936225', 'cui_str': 'Inorganic arsenic'}, {'cui': 'C0003819', 'cui_str': 'Arsenic compound'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}]","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0120451', 'cui_str': 'guanidinoacetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}]",,0.476248,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Bozack', 'Affiliation': 'Division of Pulmonary Medicine, Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Caitlin G', 'Initials': 'CG', 'LastName': 'Howe', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Slavkovich', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Ilievski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Lomax-Luu', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Faruque', 'Initials': 'F', 'LastName': 'Parvez', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Abu B', 'Initials': 'AB', 'LastName': 'Siddique', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Shahriar', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad N', 'Initials': 'MN', 'LastName': 'Uddin', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tariqul', 'Initials': 'T', 'LastName': 'Islam', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Graziano', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Gamble', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA. mvg7@cumc.columbia.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02377-z']
2684,32917424,Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program.,"INTRODUCTION


Obesity is a leading health crisis around the world. An intervention strategy scarcely utilized for behavior change is that of a child as change agent. The purpose of this study was to describe the impact of teens reviewing newsletters from a healthy lifestyle intervention with their parents.
METHOD


Evaluation data from a randomized controlled trial, COPE Healthy Lifestyle TEEN Program, was analyzed. A descriptive study was conducted of parents' and teens' lifestyle behaviors as reported by parents.
RESULTS


One hundred sixty-nine parents completed evaluations. Two thirds of parents reported changing a behavior as a result of the program. Nearly three quarters of parents reported behavior changes in their teens. Over 90% reported they would recommend this or a similar program.
DISCUSSION


The obesity epidemic shows no signs of reversal, and hence multiple approaches to impact healthy lifestyles are urgent. Including children as a change agent is a potential target for interventions addressing obesity.",2020,Nearly three quarters of parents reported behavior changes in their teens.,"['Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program', ""parents' and teens' lifestyle behaviors as reported by parents"", 'One hundred sixty-nine parents completed evaluations', 'teens reviewing newsletters from a healthy lifestyle intervention with their parents']",[],['behavior changes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",169.0,0.0232846,Nearly three quarters of parents reported behavior changes in their teens.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.06.012']
2685,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
2686,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
2687,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
2688,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS


Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS


Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS


There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION


Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
2689,32932898,Evaluation of Salivary Matrix Metalloproteinase (MMP-8) in Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil: A Randomized Clinical Trial.,"Background : Extracellular matrix metalloproteinases (MMPs) play a pivotal role in the damage to the periodontal tissue in patients with periodontitis. Scaling and root planning (SRP) attempt to control the plaque amount and consequentially reduce the bacterial load. Non-surgical periodontal treatment could be integrated with drug therapy and physiotherapy procedures such as ozone therapy. The aim of this study was to evaluate in a cohort of patients with a diagnosis of periodontitis: (1) the efficacy of non-surgical periodontal therapy assisted by the use of ozonated olive oil-based mouthwash on salivary metalloproteinase (MMP-8) and (2) the reduction of periodontal indices.  Methods : Ninety-six subjects with a diagnosis of periodontitis were enrolled in this study and randomly assigned to the study group (SRP + mouthwash) or control group (SRP). The study duration was 3 months. Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's  t -test for independent samples.  Results:  A significant improvement in PI, BoP, PPD and salivary MMP-8 levels was observed in both groups. An analysis of differences in relative changes of indices revealed the efficacy of ozonated olive oil in decreasing MMP-8 level. Simultaneously, it slowed the decrease of BoP index.  Conclusions:  Scaling and root plaining with the aid of ozonated olive oil mouthwash were found to be more effective on salivary MMP-8 reduction than scaling and root plaining alone.",2020,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","['patients with periodontitis', 'Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil', 'patients with a diagnosis of periodontitis', 'Ninety-six subjects with a diagnosis of periodontitis']","['study group (SRP + mouthwash) or control group (SRP', 'ozonated olive oil-based mouthwash', 'ozonated olive oil', 'Scaling and root planning (SRP', 'Salivary Matrix Metalloproteinase (MMP-8', ' ']","['salivary MMP-8 reduction', 'PI, BoP, PPD and salivary', 'MMP-8 level', 'BoP index', 'MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD', 'MMP-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",96.0,0.033528,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","[{'ForeName': 'Gianna Maria', 'Initials': 'GM', 'LastName': 'Nardi', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cesarano', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Papa', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Chiavistelli', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ardan', 'Affiliation': 'Chair of Econometrics, Department of Economic Sciences, Koszalin University of Technology, 75-343 Koszalin, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Jedlinski', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazur', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grassi', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, 07100 Sassari, Italy.'}, {'ForeName': 'Felice Roberto', 'Initials': 'FR', 'LastName': 'Grassi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, Aldo Moro University of Bari, 70122 Bari, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17186619']
2690,32899538,Genetic Testing and Surveillance of Young Breast Cancer Survivors and Blood Relatives: A Cluster Randomized Trial.,"We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored ( n  = 637) or the targeted ( n  = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm ( p  ≤ 0.001;  p  < 0.001) and for Black and White/Other YBCS ( p  < 0.001;  p  < 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).",2020,"Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up.","['young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives', 'Young Breast Cancer Survivors and Blood Relatives', 'from the Michigan cancer registry and up to two of their blood relatives', 'Black women at risk for hereditary breast/ovarian cancer (HBOC']",['YBCS'],"['Genetic testing', 'satisfaction and acceptability', 'CBEs and mammograms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1266852', 'cui_str': 'Blood relative'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",,0.0638018,"Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up.","[{'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Katapodi', 'Affiliation': 'Department of Clinical Research, Faculty of Medicine, University of Basel, 4055 Basel, Switzerland.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ming', 'Affiliation': 'Department of Clinical Research, Faculty of Medicine, University of Basel, 4055 Basel, Switzerland.'}, {'ForeName': 'Laurel L', 'Initials': 'LL', 'LastName': 'Northouse', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI 48109-5482, USA.'}, {'ForeName': 'Sonia A', 'Initials': 'SA', 'LastName': 'Duffy', 'Affiliation': 'College of Nursing, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Duquette', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Kari E', 'Initials': 'KE', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI 48109-5482, USA.'}, {'ForeName': 'Kara J', 'Initials': 'KJ', 'LastName': 'Milliron', 'Affiliation': 'Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}, {'ForeName': 'Sofia D', 'Initials': 'SD', 'LastName': 'Merajver', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}, {'ForeName': 'Ivo D', 'Initials': 'ID', 'LastName': 'Dinov', 'Affiliation': 'Statistics Online Computational Resource, School of Nursing, University of Michigan, Ann Arbor, MI 48109-2003, USA.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Janz', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}]",Cancers,['10.3390/cancers12092526']
2691,32898141,A pilot feasibility randomised controlled trial of two behaviour change interventions compared to usual care to reduce substance misuse in looked after children and care leavers aged 12-20 years: The SOLID study.,"BACKGROUND


Young people in state care, often due to abuse or neglect, have a four-fold increased risk of drug and alcohol use compared to their peers.
AIM


The SOLID study aimed to investigate the feasibility of a definitive randomised controlled trial, comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol), and improve mental health, in young people in care.
METHODS


We recruited young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England. Participants were randomised to either i. Motivational Enhancement Therapy (MET), ii. Social Behaviour and Network Therapy (SBNT) or iii. Control (usual care). All interventions were delivered by trained drug and alcohol workers. Follow-up data were collected 12 months post recruitment. Feasibility for trial progression was compared to pre-specified stop: go criteria (recruitment of 60% of eligible participants, 80% of participants attending 60% of offered sessions and retention of 70% of participants at 12 month follow up).
RESULTS


Of 1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised. Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires. Only 15 out of the 76 (20%) participants allocated to an intervention arm attended any of the offered MET or SBNT sessions.
CONCLUSION


By reference to pre-specified stop: go criteria it is not feasible to conduct a definitive trial for SOLID in its current format. Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here. Future work may require dedicated clinically embedded research resource to evaluate effectiveness of new interventions in services.",2020,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","['1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised', 'looked after children and care leavers aged 12-20 years', 'young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England', 'young people in care', 'Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires']","['Social Behaviour and Network Therapy (SBNT', 'behaviour change interventions', 'risky substance use (illicit drugs and alcohol', 'usual care', 'Motivational Enhancement Therapy (MET']",['mental health'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4749226', 'cui_str': 'Aging out of youth care system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",1450.0,0.0965647,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Alderson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fouweather', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'Child and Adolescent, Mental Health Services, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Smart', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': ""Population Child Health Research Group, School of Women and Children's Health, University New South Wales, Randwick, Australia.""}]",PloS one,['10.1371/journal.pone.0238286']
2692,32898170,Intramuscular stimulation vs sham needling for the treatment of chronic midportion Achilles tendinopathy: A randomized controlled clinical trial.,"BACKGROUND


The insertion of filiform needles intramuscularly (a.k.a. intramuscular stimulation/dry needling) has been suggested as a possible treatment for various painful musculoskeletal conditions. Our aim was to answer the question, is intramuscular stimulation more effective than sham intramuscular stimulation/dry needling for the treatment of Achilles tendinopathy?
METHODS


52 participants with persistent midportion Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control) (n = 8). The a priori primary outcome measure was change in VISA-A score at 12 weeks-VISA-A was also measured at 6 weeks, and at 6 and 12 months. Secondary outcome measures include the proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm).
RESULTS


The study retention was 94% at 12 weeks and 88% at 1 year. VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint. The percentage of patients who rated themselves as much or very much improved (i.e. treatment success) was not different after 12 weeks (G3 70%, G2 89%, G1 86% p = 0.94), or at 26 (p = 0.62) or 52 weeks (p = 0.71). No clinically significant effects of intervention group were observed in any of the secondary outcome measures.
CONCLUSION


The addition of intramuscular stimulation to standard rehabilitation for Achilles tendinopathy did not result in any improvement over the expected clinical benefit achieved with exercise-based rehabilitation alone.",2020,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","['chronic midportion Achilles tendinopathy', '52 participants with persistent midportion', 'Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week']","['rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control', 'sham intramuscular stimulation/dry needling', 'Intramuscular stimulation vs sham needling']","['proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm', 'change in VISA-A score', 'VISA-A score']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.107393,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","[{'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Solomons', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jenny J Y', 'Initials': 'JJY', 'LastName': 'Lee', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Kinetic Rehabilitation Centre, North Vancouver, Canada.'}, {'ForeName': 'Lynita D', 'Initials': 'LD', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}]",PloS one,['10.1371/journal.pone.0238579']
2693,32898192,Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects.,"The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica® (ver. 5.1) software. Using the log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT were calculated. The Cmax of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC0-t and AUC0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar.",2020,There was no inter and intrasubject variation (p> 0.05) that was observed.,"['healthy human subjects', '12 healthy non-smokers male subjects with overnight fasting of >10hr']",['optimized directly compressible Aceclofenac'],"['Geometric mean ratios', 'log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT', 'drug plasma concentration', 'acceptable FDA limits']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0577306', 'cui_str': 'Compressible'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024943', 'cui_str': 'Mauritania'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",12.0,0.0347567,There was no inter and intrasubject variation (p> 0.05) that was observed.,"[{'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Bushra', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Harris', 'Initials': 'MH', 'LastName': 'Shoaib', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Huma', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Ghayas', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}]",PloS one,['10.1371/journal.pone.0238951']
2694,32907896,Strategies adopted by men to deal with uncertainty and anxiety when following an active surveillance/monitoring protocol for localised prostate cancer and implications for care: a longitudinal qualitative study embedded within the ProtecT trial.,"OBJECTIVES


Active surveillance (AS) enables men with low risk, localised prostate cancer (PCa) to avoid radical treatment unless progression occurs; lack of reliable AS protocols to determine progression leaves uncertainties for men and clinicians. This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
DESIGN


Longitudinal serial in-depth qualitative interviews every 2-3 years for a median 7 (range 6-14) years following diagnosis.
SETTING


Four centres within the UK Protect trial.
PARTICIPANTS


Purposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52-68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM. Eleven men continued with AM throughout the study period (median 7 years). Nine received radical treatment after a median 4 years (range 0.8-13.8 years).
INTERVENTION


AM: 3-monthly serum prostate-specific antigen (PSA)-level assessment (year 1), 6-12 monthly thereafter; increase in PSA ≥50% during previous 12 months or patient/clinician concern triggered review.
MAIN OUTCOMES


Thematic analysis of 73 interviews identified strategies to accommodate uncertainty and anxiety of living with untreated cancer; implications for patient care.
RESULTS


Men sought clarity, control or reassurance, with contextual factors mediating individual responses. Trust in the clinical team was critical for men in balancing anxiety and facilitating successful management change/continued monitoring. Only men from ProtecT were included; men outside ProtecT may have different experiences.
CONCLUSION


Men looked to clinicians for clarity, control and reassurance. Where provided, men felt comfortable continuing AM or having radical treatments when indicated. Clinicians build patient trust by clearly describing uncertainties, allowing patients control wherever possible and being aware of how context influences individual responses. Insights indicate need for supportive services to build trust and patient engagement over the long term.
TRIAL REGISTRATION NUMBER


ISRCTN20141297; Pre-results.",2020,"This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
","['Purposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52-68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM', 'Four centres within the UK Protect trial', 'Eleven men continued with AM throughout the study period (median 7 years', 'men with low risk, localised prostate cancer (PCa', 'Only men from ProtecT were included; men outside ProtecT may have different experiences']",['radical treatment'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1828181', 'cui_str': 'Age at diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],20.0,0.0392427,"This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wade', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK julia.wade@bristol.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Athene', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Turner', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Freddie', 'Initials': 'F', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rosario', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Faculty of Medicine, Health and Human Science, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036024']
2695,32907900,Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment.,"INTRODUCTION


Telemedical lifestyle programmes for people with type 2 diabetes mellitus (T2DM) provide an opportunity to develop a healthier lifestyle and consequently to improve health outcomes. When implementing new programmes into standard care, considering patients' preferences may increase the success of the participants. This study aims to examine the preferences of people with T2DM with respect to telemedical lifestyle programmes, to analyse whether these preferences predict programme success and to explore the changes that may occur during a telemedical lifestyle intervention.
METHODS AND ANALYSIS


We outline the protocol of the development and assessment of a discrete choice experiment (DCE) to examine patient preferences in a telemedical lifestyle programme with regard to the functions of the online portal, communication, responsibilities, group activities and time requirements. To develop the design of the DCE, we conducted pilot work involving healthcare experts and in particular people with T2DM using cognitive pretesting. The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM. Preferences are being assessed before and after participants complete the programme. The DCE data will be analysed using regression and latent class analyses.
ETHICS AND DISSEMINATION


The DCE study has been approved by the ethics committee of the medical faculty of the Heinrich Heine University Duesseldorf, registration number 2018-242-ProspDEuA, registered on 6 December 2018. The TeLIPro trial is registered at the US National Library of Medicine, registration number NCT03675919, registered on 15 September 2018. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.",2020,The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM.,"['people with type 2 diabetes for telemedical lifestyle programmes in Germany', 'particular people with T2DM using cognitive pretesting', '850 members of a large German statutory health insurance with T2DM', 'people with type 2 diabetes mellitus (T2DM']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],[],,0.0670766,The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany jana.sommer@uni-duesseldorf.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dyczmons', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Grobosch', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Gontscharuk', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-036995']
2696,32911505,On the developmental origin of intrinsic honesty.,"Contrary to the self-interestedness assumption, numerous economic studies have documented that people are intrinsically honest. However, little is known about this trait's developmental origin. This study examines whether and the extent to which children in early childhood incur the intrinsic lying cost. We modified the commonly used coin-flip task into a child-friendly ball-drawing task with 10 trials and conducted the experiment with 225 child participants aged three to eight years old. We found that-although young children, on average, told two lies in the task (an average winning rate of 71%)-they lied significantly less than the maximum level (i.e., lying 100% of the time). The pattern was largely similar across gender and the age range studied. Furthermore, our child subjects' propensity to lie dropped by approximately 9% when they were randomly assigned to the treatment condition with an increased ""perceived"" intrinsic cost of lying. Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",2020,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",['225 child participants aged three to eight years old'],[],[],"[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],225.0,0.0162522,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.","[{'ForeName': 'Tai-Sen', 'Initials': 'TS', 'LastName': 'He', 'Affiliation': 'Economics Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0238241']
2697,32918519,Shared spiritual beliefs between adolescents with cancer and their families.,"BACKGROUND


FAmily CEntered (FACE) Advance Care Planning helps family decision makers to understand and honor patients' preferences for future health care, if patients cannot communicate. Spiritual well-being is a key domain of pediatric oncology care and an integral dimension of pediatric advance care planning.
PROCEDURE


As part of four-site randomized controlled trial of FACE for teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads. The prevalence-adjusted and bias-adjusted kappa (PABAK) measured congruence on FACIT-Sp-EX-4.
RESULTS


Adolescents (126) had mean age of 16.9 years, were 57% female and 79% White. Religious/spiritual classifications were: Catholic (n = 18), Protestant (n = 76), Mormon (n = 3), none/atheist (n = 22), other (n = 5), and unknown (n = 2). Agreement at item level between spiritual well-being of adolescents and families was assessed. Three items had ≥90% agreement and Excellent PABAK: ""I have a reason for living,"" ""I feel loved,"" ""I feel compassion for others in the difficulties they are facing."" Three items had <61% agreement and Poor PABAK: ""I feel a sense of harmony within myself,"" ""My illness has strengthened my faith or spiritual beliefs,"" ""I feel connected to a higher power (or God)."" Dyadic congruence was compared by social-demographics using median one-way analysis. Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
CONCLUSIONS


Family members may not share spiritual beliefs with adolescents and may be unaware of the importance of spiritual well-being for adolescents.",2020,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","['teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads', 'adolescents with cancer and their families', 'Adolescents (126) had mean age of 16.9\xa0years, were 57% female and 79% White']","['FAmily CEntered (FACE', 'FACE']","['Dyadic congruence', 'prevalence-adjusted and bias-adjusted kappa (PABAK']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",126.0,0.0242359,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Livingston', 'Affiliation': 'Grant Thornton LLP, Arlington, Virginia.'}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': 'Strategic Innovative Solutions LLC, Petersburg, Florida.'}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tweddle', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': ""Department of Oncology and Division of Quality of Life and Palliative Care, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research/Children's National Research Institute at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.'}]",Pediatric blood & cancer,['10.1002/pbc.28696']
2698,32916985,Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial.,"Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV 1 ). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI) .  We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.",2020,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).",['Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included'],"['Protocol', 'calorie-restricted Mediterranean dietary intervention', 'Low Calorie Mediterranean ']","['reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary', 'metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0628545,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Riggs', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Crowley', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Isabel R', 'Initials': 'IR', 'LastName': 'Young', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nayar', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sunseri', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Mena', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Ostrofsky', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Arul', 'Initials': 'A', 'LastName': 'Veerappan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zeig-Owens', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Colbeth', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Population Health, Division of Biostatistics, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Pompeii', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'St-Jules', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Prezant', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186569']
2699,32917039,The Retentive Strength of Zirconium Oxide Crowns Cemented by Self-Adhesive Resin Cements before and after 6 Months of Aging.,"The aim of this study was to evaluate the retentive strength of zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP)) crown-copings treated by combined mechanical and chemical treatments and cemented by four types of self-adhesive resin cements (SARCs) to human prepared teeth, before and after six months of aging in water and thermocycling. A total of 120 molar teeth were mounted, prepared using a standardized protocol and digitally scanned, and Y-TZP copings were produced. Teeth were randomly assigned to four SARC groups. Prior to cementation, the intaglio surfaces of all crowns were sandblasted and then coated with Z-Prime™ Plus (Bisco Dental, Schaumburg, IL, USA). Post cementation, each cement group was subdivided into aged and non-aged groups. After aging, the cemented assemblies were tested for retentive strength using a universal testing machine. Failure analysis was conducted by inspecting all matched debonded surfaces of the teeth and crowns at 3× magnification. Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918). The interaction between cement and aging was statistically significant ( p  = 0.024). No significant differences in the retentive strengths between the different SARCs were observed pre-aging ( p  = 0.776), whereas post-aging, Panavia SA (PAN; Kuraray Dental Co Ltd., Osaka, Japan) showed significantly higher strength than RelyX U-200 (RU200; 3M ESPE, Seefeld, Germany). The predominant failure mode was adhesive between the cement and dentin, followed by mixed mode failure.",2020,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,['A total of 120 molar teeth'],['zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP'],"['Retentive Strength', 'retentive strength', 'retentive strengths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}]",[],120.0,0.024198,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,"[{'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Levartovsky', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Lilac', 'Initials': 'L', 'LastName': 'Cartier', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Jaron John', 'Initials': 'JJ', 'LastName': 'Blasbalg', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Pilo', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}]","Materials (Basel, Switzerland)",['10.3390/ma13183998']
2700,32919416,"Sociodemographic, Lifestyle and Medical Factors Associated with Helicobacter Pylori Infection.","BACKGROUND AND AIMS


The prevalence of Helicobacter pylori (H. pylori) infection is higher in developing countries and is often linked to lower socioeconomic status. Few studies have investigated the association between H. pylori and individual level characteristics in Europe, where several countries have a high prevalence of H. pylori infection. The study aimed to identify risk factors for H. pylori infection among adults in a large clinical trial in Latvia.
METHODS


1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis. Sociodemographic, lifestyle and medical factors were compared for participants seropositive (H. pylori+) and seronegative. Mutually adjusted odds ratios (OR) were calculated for H. pylori+ and factors significant in univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease), adjusting for age, gender and income.
RESULTS


Of the participants 1,044 (55.4%) were H. pylori seropositive. The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (OR: 1.32; 95%CI: 1.03-1.69) and inversely with ≥400g vegetables/fruit daily (OR: 0.76; 95%CI: 0.60-0.96), history of H. pylori eradication (OR: 0.57; 95%CI: 0.39-0.84), peptic ulcer (OR: 0.55; 95%CI: 0.38-0.80) and cardiovascular disease (OR: 0.78; 95%CI: 0.61-0.99).
CONCLUSIONS


After mutual adjustment, H. pylori seropositivity was associated with lifestyle and in particular dietary factors rather than socioeconomic indicators in contrast to the majority of other studies.",2020,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","['1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis', 'adults in a large clinical trial in Latvia']",[],"['Helicobacter pylori (H. pylori) infection', 'history of H. pylori eradication ', 'univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease', 'Mutually adjusted odds ratios (OR', 'peptic ulcer', 'cardiovascular disease']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030913', 'cui_str': 'Pepsinogen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1277797', 'cui_str': 'Helicobacter pylori IgG antibody measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1044.0,0.111375,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","[{'ForeName': 'Danute', 'Initials': 'D', 'LastName': 'Razuka-Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. d.razuka.ebela@gmail.com.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Polaka', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. inese.polaka@gmail.com.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Parshutin', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. sergejs.parsutins@lu.lv.'}, {'ForeName': 'Daiga', 'Initials': 'D', 'LastName': 'Santare', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. daiga.santare@lu.lv.'}, {'ForeName': 'Inguna', 'Initials': 'I', 'LastName': 'Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia. inguna.ebela@gmail.com.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Murillo', 'Affiliation': 'Hospital Universitario San Ignacio, Bogota, Columbia. raulhmurillo@yahoo.com.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. rherrero@acibcr.com.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Tzivian', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia; Holon Institute of Technology, Holon, Israel. liliana.tz@gmail.com.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Young Park', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. ParkJY@iarc.fr.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Leja', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. marcis.leja@lu.lv.'}]",Journal of gastrointestinal and liver diseases : JGLD,['10.15403/jgld-870']
2701,32928851,Rhythm and Movement for Self-Regulation (RAMSR) intervention for preschool self-regulation development in disadvantaged communities: a clustered randomised controlled trial study protocol.,"INTRODUCTION


Self-regulation (the ability to regulate emotion, attention, cognition and behaviour) is an integral part of early learning competence in the years prior to school. Self-regulation skills are critical to ongoing learning behaviours, achievement and well-being. Emerging neurological evidence suggests coordinated music and movement participation could support self-regulation development for all children. A pilot study in 2016 introduced a coordinated music and movement programme designed to boost self-regulation skills in children in disadvantaged communities, delivered by visiting specialists, with promising findings. The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR). This study builds on the pilot by training regular teachers to deliver RAMSR in their classrooms (rather than visiting specialists). The study aims to establish the effectiveness of RAMSR, which is designed to translate the cognitive benefits that accrue from rhythm participation to address self-regulation for children who do not typically access high-quality music programmes.
METHODS AND ANALYSIS


We will recruit 237 children from up to eight kindergartens in low socioeconomic areas.
INTERVENTION


teachers will be trained to deliver the RAMSR intervention during group time in kindergartens, daily for 8 weeks.
CONTROL


usual practice kindergarten programme.
FOLLOW-UP


end of intervention using child assessments and teacher report; 12 months postbaseline using school teacher reports following school transition. Primary outcomes: executive function and self-regulation.
SECONDARY OUTCOMES


school readiness; visual-motor integration; teacher-reported behaviour problems, school transition and academic competency; teacher knowledge, confidence, practice and attitudes related to self-regulation, rhythm and movement; fidelity of intervention implementation.
ETHICS AND DISSEMINATION


Queensland University of Technology Human Research Ethics Committee, approval 1900000566. Findings dissemination: in-field workshops to service providers, conference presentations, journal and professional publications.
TRIAL REGISTRATION NUMBER


ACTRN12619001342101; Pre-results (30 September 2019).",2020,"The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR).","['disadvantaged communities', 'children who do not typically access high-quality music programmes', '237 children from up to eight kindergartens in low socioeconomic areas', 'children in disadvantaged communities, delivered by visiting specialists, with promising findings']","['RAMSR intervention', 'music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR', 'RAMSR', 'Rhythm and Movement for Self-Regulation (RAMSR) intervention', 'coordinated music and movement programme designed to boost self-regulation skills']","['visual-motor integration', 'behaviour problems, school transition and academic competency; teacher knowledge, confidence, practice and attitudes related to self-regulation, rhythm and movement; fidelity', 'executive function and self-regulation']","[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",237.0,0.03755,"The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR).","[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Williams', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia k15.williams@qut.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Savage', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Eager', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036392']
2702,32928863,"Beta-alanine supplementation in patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation: protocol of two randomised, double-blind, placebo-controlled trials.","INTRODUCTION


Exercise intolerance is common in patients with chronic obstructive pulmonary disease (COPD) and, although multifactorial, it is largely caused by lower-limb muscle dysfunction. Research has shown that patients with severe to very severe COPD have significantly lower levels of muscle carnosine, which acts as a pH buffer and antioxidant. Beta-alanine (BA) supplementation has been shown to consistently elevate muscle carnosine in a variety of populations and may therefore improve exercise tolerance and lower-limb muscle function. The primary objective of the current studies is to assess the beneficial effects of BA supplementation in enhancing exercise tolerance on top of two types of exercise training (non-linear periodised exercise (NLPE) training or neuromuscular electrical stimulation (NMES)) in patients with COPD.
METHODS AND ANALYSIS


Two randomised, double-blind, placebo-controlled trials have been designed. Patients will routinely receive either NLPE (BASE-TRAIN trial) or NMES (BASE-ELECTRIC trial) as part of standard exercise-based care during their 8-to-10 week pulmonary rehabilitation (PR) programme. A total of 222 patients with COPD (2×77 = 154 patients in the BASE-TRAIN trial and 2×34 = 68 patients in the BASE-ELECTRIC trial) will be recruited from two specialised PR centres in The Netherlands. For study purposes, patients will receive 3.2 g of oral BA supplementation or placebo per day. Exercise tolerance is the primary outcome, which will be assessed using the endurance shuttle walk test (BASE-TRAIN) or the constant work rate cycle test (BASE-ELECTRIC). Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
ETHICS AND DISSEMINATION


Both trials were approved by CMO Regio Arnhem-Nijmegen, The Netherlands (NL70781.091.19. and NL68757.091.19).
TRIAL REGISTRATION NUMBER


NTR8427 (BASE-TRAIN) and NTR8419 (BASE-ELECTRIC).",2020,"Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
","['222 patients with COPD (2×77 = 154 patients in the BASE-TRAIN trial and 2×34 = 68 patients in the BASE-ELECTRIC trial) will be recruited from two specialised PR centres in The Netherlands', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'patients with severe to very severe COPD', 'patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation']","['BA supplementation', 'Beta-alanine (BA) supplementation', 'NMES', 'NLPE', 'standard exercise-based care during their 8-to-10 week pulmonary rehabilitation (PR) programme', 'placebo', 'oral BA supplementation or placebo', 'Beta-alanine supplementation', 'exercise training (non-linear periodised exercise (NLPE) training or neuromuscular electrical stimulation (NMES']","['Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1446110', 'cui_str': 'Urine beta-alanine measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",222.0,0.592063,"Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Meys', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands roymeys@ciro-horn.nl.'}, {'ForeName': 'Anouk A F', 'Initials': 'AAF', 'LastName': 'Stoffels', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'de Brandt', 'Affiliation': 'Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium.'}, {'ForeName': 'Hieronymus W H', 'Initials': 'HWH', 'LastName': 'van Hees', 'Affiliation': 'Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands.'}, {'ForeName': 'Frits M E', 'Initials': 'FME', 'LastName': 'Franssen', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Maurice J H', 'Initials': 'MJH', 'LastName': 'Sillen', 'Affiliation': 'Department of Physiotherapy, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Burtin', 'Affiliation': 'Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klijn', 'Affiliation': 'Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Bij de Vaate', 'Affiliation': 'Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'van den Borst', 'Affiliation': 'Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Otker', 'Affiliation': 'Patient Advisory Council, Lung Foundation Netherlands, Amersfoort, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Donkers', 'Affiliation': 'Client Council, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Florence N', 'Initials': 'FN', 'LastName': 'Schleich', 'Affiliation': 'Department of Respiratory Medicine, CHU Sart-Tilman Liege, GIGA I3, Liege, Belgium.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Hayot', 'Affiliation': 'PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pomiès', 'Affiliation': 'PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Everaert', 'Affiliation': 'Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Derave', 'Affiliation': 'Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Spruit', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038836']
2703,32929107,Prolonged bedrest reduces plasma high-density lipoprotein levels linked to markedly suppressed cholesterol efflux capacity.,"Recent observations strongly connect high-density lipoproteins (HDL) function and levels with coronary heart disease outcomes and risk for infections and sepsis. To date, our knowledge of factors determining this connection is still very limited. The immobility associated with prolonged bedrest is detrimental to health, affecting several systems, including the cardiovascular, pulmonary, gastrointestinal, musculoskeletal and urinary. Effects of prolonged bedrest on the composition and functional properties of HDL remain elusive. We evaluated metrics of HDL composition and function in healthy male volunteers participating in a randomized, crossover head-down bedrest study. We observed that HDL cholesterol efflux capacity was profoundly decreased during bedrest, mediated by a bedrest associated reduction in plasma levels of HDL-cholesterol and major apolipoproteins (apo) apoA-I and apoA-II. Paraoxonase activity, plasma anti-oxidative capacity and the activities of lecithin-cholesterol acyltransferase and cholesteryl ester transfer protein were not affected. No change was observed in the content of HDL-associated serum amyloid A, a sensitive marker of inflammation. Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase. In conclusion, prolonged bedrest reduces plasma HDL levels linked to markedly suppressed HDL cholesterol efflux capacity. Resistive vibration exercise during bedrest did not correct HDL levels and impaired cholesterol efflux capacity.",2020,Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase.,"['healthy male volunteers participating in a randomized, crossover head-down bedrest study']","['Resistive vibration exercise', 'Resistive vibration exercise countermeasure']","['plasma HDL levels', 'Paraoxonase activity, plasma anti-oxidative capacity and the activities of lecithin-cholesterol acyltransferase and cholesteryl ester transfer protein', 'plasma levels of HDL-cholesterol and major apolipoproteins (apo', 'HDL cholesterol efflux capacity', 'content of HDL-associated serum', 'cholesterol efflux capacity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052451', 'cui_str': 'Arylesterase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023194', 'cui_str': 'Phosphatidylcholine-sterol acyltransferase'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0172899,Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase.,"[{'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Trakaki', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Scharnagl', 'Affiliation': 'Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Trieb', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holzer', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hinghofer-Szalkay', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Neue Stiftingtalstrasse 6/D-5, 8010, Graz, Austria.'}, {'ForeName': 'Nandu', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Neue Stiftingtalstrasse 6/D-5, 8010, Graz, Austria. nandu.goswami@medunigraz.at.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Marsche', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria. gunther.marsche@medunigraz.at.'}]",Scientific reports,['10.1038/s41598-020-71921-y']
2704,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Allied Medical Sciences, Arab American University, Jenin, Palestine. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
2705,32910735,Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial.,"Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired  t  tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women,  M   age  = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes ( p  < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml:  p  < .025; 10 ml:  p  < .0012), and sEMG burst duration was also equivalent (5 ml:  p  < .0001; 10 ml:  p  < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch ( p  = .0476,  d  = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.",2020,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","['During Swallowing', 'Forty healthy adults participated (24 women,  M   age  = 67.5 years', 'patients with dysphagia', 'healthy older adults']","['Surface electromyography (sEMG', 'sEMG patch with conventional (snap-on) sEMG electrodes', 'Novel Wearable Electromyography Patch']","['sEMG burst duration', 'normalized amplitude values', 'Safety/preclinical factors', 'mild adverse effects', 'signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort', 'Participant satisfaction', 'Monitoring Submental Muscle Activity', 'safety, efficiency, and signal quality']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",40.0,0.0897228,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Kantarcigil', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Min Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Taehoo', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'School of Materials Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Chi Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Malandraki', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00171']
2706,32906163,[Reduction of Visitor- and Staff-Associated Risk of Infection by Complex Intervention in the Department of Feto-Maternal Medicine].,"AIM


Clinical trial registration of this trial: is to demonstrate in a department of feto-maternal medicine: (a) that a complex intervention improves hand hygiene of visitors, siblings and staff; and (b) that automated voice prompts at disinfectant dispensers improve rate of hand disinfection.
STUDY DESIGN


(a) Pre-/post-test follow-up design with control (1-12/2016), intervention (1-12/2017), follow-up-period (1/2018-12/2019); and (b) RCT in quasi crossover design. Primary endpoints: (a) disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by.
RESULTS


A multimodal strategy within the intervention period showed a relevant positive effect on hand hygiene compliance (in IP: 26.2% more DC; p=0.088). Voice prompts increased DC by 28.6% (p=0.025). The odds ratio for high positive fingertip testing plates of visiting children (siblings) between control and intervention period was 0.35 (95% CI [0.1074-0.9708] p=0.039).
CONCLUSION


Complex intervention and electronic voice prompts on disinfectant dispensers improve hand hygiene behaviour in perinatology. Installation of disinfectant dispensers in a child-friendly position and adequate information material appeal to children. The data represent an important contribution to improve hand hygiene of visitors, siblings and staff in hospitals in a pandemic situation.",2020,Voice prompts increased DC by 28.6% (p=0.025).,['perinatology'],['complex intervention'],"['Visitor- and Staff', 'hand hygiene compliance', 'disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by', 'rate of hand disinfection']","[{'cui': 'C0031063', 'cui_str': 'Perinatology'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0999347', 'cui_str': 'Passer'}, {'cui': 'C0018570', 'cui_str': 'Disinfection, Hand'}]",,0.094279,Voice prompts increased DC by 28.6% (p=0.025).,"[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Seliger', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Krol', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Worlitzsch', 'Affiliation': 'Universitätsklinikum/Stabsstelle Krankenhaushygiene, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institut für Medizinische Epidemiologie, Biometrie und Informatik, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Medizincontrolling/Sachgebiet Klinische Infektologie, Universitätsklinikum Halle (Saale), Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tchirikov', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1226-7257']
2707,32917784,A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).,"BACKGROUND


Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.
METHODS


To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.
RESULTS


A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m 2 ; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.
CONCLUSIONS


In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Australian Clinical Trials Registry, ACTRN12610000650099.",2020,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","['278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg', '138 participants received', 'patients with CKD who have normophosphatemia', 'mean age 63.1 years; 69% male, 64% White']","['phosphate-lowering medication', 'lanthanum carbonate or matched placebo', 'non-calcium-based phosphate binders', 'lanthanum', 'Phosphate Reduction', 'placebo']","['mean pulse wave velocity', 'abdominal aortic calcification', 'vascular calcification and arterial stiffness', 'pulse wave velocity', 'fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality', 'abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate', 'Mean serum phosphate', 'Serious adverse events', 'cardiovascular disease', 'arterial stiffness or aortic calcification', 'cardiovascular risk', 'abdominal aortic calcification and serum and urine markers of mineral metabolism', 'Mean eGFR', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0023031', 'cui_str': 'Lanthanum'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",278.0,0.574529,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","[{'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia Nigel.Toussaint@mh.org.au.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Pedagogos', 'Affiliation': 'Department of Medicine, The Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Lioufas', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Grahame J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'School of Medicine, University of Notre Dame, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': 'St. George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valks', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Plano, Texas.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sylvia S M', 'Initials': 'SSM', 'LastName': 'Chen', 'Affiliation': 'Epworth Healthcare, Melbourne, Victoria, Australia.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Concord Repatriation and General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lai-Seong', 'Initials': 'LS', 'LastName': 'Hooi', 'Affiliation': 'Sultanah Aminah Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Narayan', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Angela Yee Moon', 'Initials': 'AYM', 'LastName': 'Wang', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020040411']
2708,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
2709,32916236,"Radiation-induced lymphopenia during chemoradiation therapy for non-small cell lung cancer is linked with age, lung V5, and XRCC1 rs25487 genotypes in lymphocytes.","BACKGROUND & PURPOSE


We investigated clinical and genetic factors associated with severe radiation-induced lymphopenia (RIL) in a randomized clinical trial of photon vs. proton radiation, with chemotherapy, for non-small cell lung cancer.
METHODS


XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples. Severe RIL was defined as absolute lymphocyte count (ALC) < 0.3 × 10 9  cells/L. Univariate and multivariate analyses were used to identify independent risk factors, which were then used to group patients for risk of severe RIL.
RESULTS


Univariate analysis of the 178 patients in this analysis showed that older age, larger tumors, higher lung V5 and mean lung dose, and higher heart V5 and mean heart dose were associated with severe RIL during treatment (P < 0.05). The XRCC1 rs25487 AA genotype was also associated with increased risk of severe RIL during treatment (AA vs. others: hazard ratio [HR] = 1.665, 95% confidence interval [CI] 1.089-2.500, P = 0.018). Multivariate analyses showed that older age (HR = 1.031, 95% CI 1.009-1.054, P = 0.005), lung V5 (HR = 1.039, 95% CI 1.023-1.055, P < 0.0001), and AA genotype (AA vs. others, HR = 1.768, 95% CI 1.165-2.684, P = 0.007) were independently associated with higher incidence of severe RIL. These three risk factors (age ≥ 56 years, lung V5 ≥ 51% and XRCC1 rs25487 AA) distinguished patients at different risk of developing severe RIL (P < 0.0001).
CONCLUSIONS


Age, lung V5 and XRCC1 rs25487 AA were all linked with risk of severe RIL. Our predictive risk model may be helpful for identifying patients at high risk of severe RIL so that treatment can be modified.",2020,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.",['XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples'],"['Radiation-induced lymphopenia during chemoradiation therapy', 'photon vs. proton radiation, with chemotherapy']","['lung V5', 'Severe RIL', 'severe RIL', 'absolute lymphocyte count (ALC', 'risk of severe RIL']","[{'cui': 'C0250029', 'cui_str': 'XRCC1 protein, human'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0033727', 'cui_str': 'Proton'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",178.0,0.0968706,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Hekun', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: TXu@mdanderson.org.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.002']
2710,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
2711,32925287,"Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5.","BACKGROUND


Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study.
METHODS


MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China).
RESULTS


Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52.
CONCLUSIONS


Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1.",2020,All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52.,"['Eligible patients', '458 patients (secukinumab 150 mg', 'patients with ankylosing spondylitis (AS', 'patients with AS from the MEASURE 5 study', '305; placebo, N\u200a=\u200a153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China']","['Secukinumab', 'placebo', 'secukinumab', 'subcutaneous secukinumab 150 mg or placebo']","['signs and symptoms of ankylosing spondylitis', 'SpondyloArthritis international Society (ASAS', 'ASAS20 response', 'Efficacy and safety', 'tolerated and the safety profile', 'signs and symptoms of AS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517679', 'cui_str': '28.6'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",458.0,0.232244,All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52.,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ""Department of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ""Department of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Wei-Guo', 'Initials': 'WG', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Wu', 'Affiliation': ""Department of Rheumatology & Immunology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China.""}, {'ForeName': 'Ling-Li', 'Initials': 'LL', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology & Immunology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology & Immunology, Guangdong General Hospital, Guangzhou, Guangdong 510000, China.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sengupta', 'Affiliation': 'Royal National Hospital for Rheumatic Disease, Upper Borough Walls, Bath BA1 1RL, UK.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Šenolt', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Hao-Min', 'Initials': 'HM', 'LastName': 'Qiu', 'Affiliation': 'China Novartis Institutes for Biomedical Research, Shanghai 201203, China.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Haemmerle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Chinese medical journal,['10.1097/CM9.0000000000001099']
2712,32925344,ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery.,"BACKGROUND


Recent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear.
METHODS


This exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery.
RESULTS


All outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5).
CONCLUSIONS


The use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.",2020,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","['Two hundred and four patients with a mean age of 72 ± 5 years were studied', 'Older Surgical Patients Undergoing Major Noncardiac Surgery', 'patients who were ≥65 years of age undergoing elective noncardiac surgery', 'cognitively vulnerable patients']","['ADAPT-2', 'Intraoperative EEG Suppression', 'processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA']","['EEG suppression and subsequent postoperative delirium', 'incidence rate ratio', 'Minutes of EEG suppression adjusted by the length of surgery', 'incident postoperative delirium', 'Preoperative cognitive impairment', 'intraoperative EEG suppression', 'incidence of delirium', 'EEG suppression']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",204.0,0.158331,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tang', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Sands', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Pleasants', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabatabai', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Leung', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004713']
2713,32927674,"Use of End-of-Class Quizzes to Promote Pharmacy Student Self-Reflection, Motivate Students to Improve Study Habits, and to Improve Performance on Summative Examinations.","Underperforming students are often unaware of deficiencies requiring improvement until after poor performance on summative exams. The goal of the current study was to determine whether inclusion of individual end-of-class formative quizzes, which comprise of higher level Bloom's questions, could encourage students to reflect on and address deficiencies and improve academic performance. Ninety-seven out of 123 first-year pharmacy students (79%) enrolled in a Biochemistry and Cell & Molecular Biology course participated in a single-blinded, randomized, controlled, crossover study. Paired  t -test analyses demonstrated that that implementation of individual end-of-class formative quizzes resulted in significantly higher summative exam scores for below average students ( p  = 0.029). Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006). Analysis of surveys completed by students prior to summative exam indicate that the formative end-of-class quizzes helped students identify deficiencies (89%) and making them feel compelled to study more (83%) and attend review sessions (61%). Many students indicated that quizzes increased stress levels (45%). Our collective data indicate that quizzes can improve summative exam performance for below average first year pharmacy students, and improve self-reflection and student motivation to study. However, the impact on student stress levels should be considered.",2020,"Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006).","['Ninety-seven out of 123 first-year pharmacy students (79%) enrolled in a Biochemistry and Cell & Molecular Biology course participated', 'Underperforming students']",[],"['summative exam performance', 'summative exam scores', 'stress levels']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026376', 'cui_str': 'Biology, Molecular'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",123.0,0.0147359,"Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Vinall', 'Affiliation': 'Department of Pharmaceutical & Biomedical Sciences, College of Pharmacy, California Northstate University, Elk Grove, CA 95826, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kreys', 'Affiliation': 'Department of Clinical & Administrative Sciences, College of Pharmacy, California Northstate University, Elk Grove, CA 95826, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8030167']
2714,32936416,"A Multimorbidity-Based, Risk-Stratified Reanalysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Trial.","INTRODUCTION


Multimorbidity is common in patients with cardiovascular disease. Clinical trials in cardiovascular medicine mostly enroll patients who are younger, healthier, and more affluent than average patients with the condition of interest. These trials rarely account for patient-level multimorbidity in a systematic fashion. Further, treatment effect heterogeneity is usually tested across subgroups of patients based on the presence or absence of individual variables, not on the basis of summative risk scores that account for multimorbidity. Thus, the impact of multimorbidity on treatment effects is poorly understood.
METHODS


In this study, we performed a multimorbidity-based risk-stratified reanalysis of the AFFIRM (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) trial. Our objectives were to describe the distribution of multimorbidity using a modified version of the Charlson Comorbidity Index (mCCI), scale 0-14, and to assess its impact on the original primary endpoint of all-cause mortality.
RESULTS


The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44). However, for patients with an mCCI ≥ 5 (44.5%), there was a strong trend toward a reduction in death with rate control that nearly reached statistical significance despite being underpowered (24.5 vs. 28.3%; p = 0.07).
CONCLUSION


This proof-of-concept study supports the idea that clinical trials in cardiovascular medicine should systematically assess for multimorbidity and investigate its potential impact on treatment effects.",2020,"The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44).","['patients with cardiovascular disease', 'cardiovascular medicine mostly enroll patients who are younger, healthier, and more affluent than average patients with the condition of interest']",[],"['mCCI score', 'risk of death for rate versus rhythm control', 'death with rate control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0846487,"The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ruzieh', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Cardiology Group, Louisville, KY, USA.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Foy', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA. afoy@pennstatehealth.psu.edu.'}]",Drugs & aging,['10.1007/s40266-020-00797-4']
2715,32933029,Longitudinal Evaluation of Working Memory in Duchenne Muscular Dystrophy.,"Objective:  The developmental maturation of forward and backward digit spans-indices of working memory-in boys with nonsense (nm) Duchenne muscular dystrophy (DMD) (nmDMD) was assessed using prospective, longitudinal data. Methods: Fifty-five boys of the 57 subjects with genetically confirmed nmDMD-who were from the placebo arm of a 48-week-long phase 2b clinical trial-were evaluated. Forward and backward digit spans were obtained every 12 weeks for a total of five assessments in all study subjects. Changes in forward and backward digit spans were evaluated based on age, corticosteroid treatment, and DMD mutation location.  Results:  Boys with nmDMD had lower mean scores on normalized forward digit span. Normalized forward digit spans were comparable between subjects stratified by age and between corticosteroid-naïve and corticosteroid-treated subjects. When stratified by DMD mutation location, normalized forward digit spans were lower in nmDMD subjects with mutations downstream of DMD exon 30, exon 45, and exon 63, both at baseline evaluation and at follow-up evaluation at 48 weeks. On average, normalized backward digit span scores were stable over 48 weeks in these subjects. Developmental growth modeling showed that subjects with nmDMD mutations upstream of DMD exon 30, upstream of DMD exon 45, and upstream of DMD exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  Conclusion:  Performance in working memory shows deficits in nmDMD and differed based on nmDMD location. Maturation in cognition was seen over a 48-week period. The developmental trajectory of working memory in this cohort was influenced by  DMD  mutation location.",2020,"exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  ","['Methods: Fifty-five boys of the 57 subjects with genetically confirmed nmDMD-who were from the placebo arm of a 48-week-long phase 2b clinical trial-were evaluated', 'Duchenne Muscular Dystrophy', 'nmDMD subjects with mutations downstream of DMD', 'subjects with nmDMD mutations upstream of DMD exon 30, upstream of DMD exon 45, and upstream of DMD', 'boys with nonsense (nm) Duchenne muscular dystrophy (DMD) (nmDMD']",[],"['working memory', 'normalized forward digit span', 'Normalized forward digit spans', 'normalized backward digit span scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0544885', 'cui_str': 'Nonsense mutation'}]",[],"[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",57.0,0.0329416,"exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  ","[{'ForeName': 'Mathula', 'Initials': 'M', 'LastName': 'Thangarajh', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, 1101 East Marshall Street, P.O. Box 980599, Richmond, VA 23298, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Elfring', 'Affiliation': 'PTC Therapeutics Inc., South Plainfield, NJ 07080, USA.'}, {'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Trifillis', 'Affiliation': 'PTC Therapeutics Inc., South Plainfield, NJ 07080, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092940']
2716,32933119,Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults.,"This study examined the effects of a person-centered nursing intervention program for frailty (PNIF) targeting community-dwelling prefrail older people in South Korea. The study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index. The intervention group ( n  = 20) received group intervention sessions two days/week for twelve weeks and the control group ( n  = 20) attended lectures about frailty prevention one day/week for four weeks. The evaluation instruments included the CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS). Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks. No significant between-group differences in ESSI scores were observed. The PNIF effectively improved grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty among community-dwelling older adults.",2020,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","['study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index', 'Prefrail Community-Dwelling Older Adults', 'frailty (PNIF) targeting community-dwelling prefrail older people in South Korea']","['Person-Centered Nursing Intervention', 'control group ( n  = 20) attended lectures about frailty prevention', 'person-centered nursing intervention program']","['grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty', 'SPPB', 'ESSI scores', 'right-hand grip strength', 'K-CHAMPS', 'CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS', 'CHS Frailty Index', 'left-hand grip strength']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",40.0,0.0117517,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","[{'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'College of Nursing, Konyang University, Daejeon 35365, Korea.'}, {'ForeName': 'Yeon-Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Seoul National University, Seoul 03080, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186660']
2717,32934335,Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets.,"Enamel demineralisation can occur as a side effect during orthodontic treatment with fixed appliances. This study aimed to evaluate the efficacy of the self-assembling peptide P 11 -4 for remineralisation combined with fluorides, compared to application of fluoride varnish alone. De- and remineralisation was assessed by Quantitative light-induced fluorescence (QLF). Orthodontic brackets were bonded on 108 human enamel samples and white spot lesions were created. The samples were allocated randomly into three groups: Group I received no treatment, group II had a single application of fluoride varnish (22,600 ppm), and group III was treated with P 11 -4 following a single application of fluoride varnish. Quantitative light-induced fluorescence (QLF) measurements were performed at baseline, after demineralisation and after storage in remineralisation solution for 7 and 30 days. Non-parametric tests (Kruskal-Wallis test and Friedman test) were used for further analysis. After demineralisation, all samples showed a median ΔF -9.38% ± 2.79. After 30 days median ΔF values were as followed: group I = -9.04% ± 2.51, group II = -7.89 ± 2.07, group III = -6.08% ± 2.79). The median ΔF values differed significantly between all groups at all investigation times (p < 0.00001). Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.",2020,Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.,['remineralisation of artificial early enamel lesions adjacent to orthodontic brackets'],"['fluoride varnish', 'fluoride varnish alone']","['Quantitative light-induced fluorescence (QLF', 'Quantitative light-induced fluorescence (QLF) measurements', 'median ΔF values', 'De- and remineralisation']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C4704843', 'cui_str': 'Quantitative Light-Induced Fluorescence'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0197051,Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Jablonski-Momeni', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany. momeni@staff.uni-marburg.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nothelfer', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morawietz', 'Affiliation': 'Fraunhofer Institute for Microstructure of Materials and Systems IMWS, Halle (Saale), Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiesow', 'Affiliation': 'Fraunhofer Institute for Microstructure of Materials and Systems IMWS, Halle (Saale), Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Korbmacher-Steiner', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-72185-2']
2718,32941462,Provider anticipation and experience of patient reaction when deprescribing guideline discordant inhaled corticosteroids.,"INTRODUCTION


Despite evidence of possible patient harm and substantial costs, medication overuse is persistent. Patient reaction is one potential barrier to deprescribing, but little research has assessed this in specific instances of medication discontinuation. We sought to understand Veteran and provider experience when de-implementing guideline-discordant use of inhaled corticosteroids (ICS) in those with mild-to-moderate chronic obstructive pulmonary disease (COPD).
METHODS


We conducted a mixed-methods analysis in a provider-randomized quality improvement project testing a proactive electronic-consultation from pulmonologists recommending ICS discontinuation when appropriate. PCPs at two Veterans Health Administration healthcare systems were included. We completed interviews with 16 unexposed providers and 6 intervention-exposed providers. We interviewed 9 patients within 3 months after their PCP proposed ICS discontinuation. We conducted inductive and deductive content analysis of qualitative data to explore an emergent theme of patient reaction. Forty-eight PCPs returned surveys (24 exposed and 24 unexposed, response rate: 35%).
RESULTS


The unexposed providers anticipated their patients might resist ICS discontinuation because it seems counterintuitive to stop something that is working, patient's fear of worsening symptoms, or if the prescription was initiated by another provider. Intervention-exposed providers reported similar experiences in post-intervention interviews. Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies. This was echoed by intervention-exposed providers who had successfully discontinued an ICS. Veterans reported acceding to their providers out of trust or deference to their advanced training, even after describing an ICS as a 'security blanket'. Our survey findings supported the subthemes from our interviews. Among providers who proposed discontinuation of an ICS, 76% reported that they were able to discontinue it or switch to another more appropriate medication.
CONCLUSIONS


While PCPs anticipated that patients would resist discontinuing an ICS, interviews with patient and intervention-exposed PCPs along with surveys suggest that patients were receptive to this change.",2020,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","['16 unexposed providers and 6 intervention-exposed providers', 'those with mild-to-moderate chronic obstructive pulmonary disease (COPD']",['inhaled corticosteroids (ICS'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],9.0,0.0455836,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","[{'ForeName': 'Toral J', 'Initials': 'TJ', 'LastName': 'Parikh', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Krysttel C', 'Initials': 'KC', 'LastName': 'Stryczek', 'Affiliation': 'VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Sayre', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Feemster', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Majerczyk', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Seppo T', 'Initials': 'ST', 'LastName': 'Rinne', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0238511']
2719,32941476,A randomized pilot trial to evaluate the benefit of the concomitant use of atorvastatin and Raltegravir on immunological markers in protease-inhibitor-treated subjects living with HIV.,"OBJECTIVE


Optimization of antiretroviral therapy and anti-inflammatory treatments, such as statins, are among the strategies aimed at reducing metabolic disorders, inflammation and immune activation in people living with HIV (PLWH). We evaluated the potential benefit of combining both strategies.
DESIGN


Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen were randomized (1:1) to switch from PI to Raltegravir (n = 20), or to remain on PI (n = 22). After 24 weeks, all patients received atorvastatin 20mg/day for 48 weeks.
METHODS


We analyzed plasma inflammatory as well as T-cell maturation, activation, exhaustion and senescence markers at baseline, 24 and 72 weeks.
RESULTS


Plasma inflammatory markers remained unchanged. Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed. Only a modest decrease in the frequency of CD38+ CD8 T cells and an increase in the frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments were noticed in the Raltegravir-switched group.
CONCLUSIONS


The study combined antiretroviral switch to Raltegravir and Statin-based anti-inflammatory strategies to reduce inflammation and chronic immune activation in PLWH. Although this combination was safe and well tolerated, it had minimal impact on inflammatory and immunological markers.
CLINICAL TRIALS REGISTRATION


NCT02577042.",2020,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","['Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen', 'protease-inhibitor-treated subjects living with HIV', 'people living with HIV (PLWH']","['atorvastatin and Raltegravir', 'Raltegravir and Statin-based anti-inflammatory strategies', 'atorvastatin', 'Raltegravir']","['T-cell maturation, activation, exhaustion and senescence markers', 'safe and well tolerated', 'frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments', 'frequency of CD38+ CD8 T cells', 'T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0075747', 'cui_str': 'Lymphocyte antigen CD28'}, {'cui': 'C0054965', 'cui_str': 'Lymphocyte antigen CD57'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0596761', 'cui_str': 'Immunosenescence'}]",,0.0296761,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","[{'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Jiménez', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Loste', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Urrea', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Echeverría', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bonjoch', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'Infectious Diseases and Immunity, Centre for Health and Social Care Research (CESS), Faculty of Medicine, University of Vic-Central University of Catalonia (UVic-UCC), Catalonia, Spain.'}]",PloS one,['10.1371/journal.pone.0238575']
2720,32941526,Muscle activation with swinging loads in bench press.,"The aim of the study was to compare the EMG amplitude in bench press (stable loads) to bench press using loads moving in anteroposterior and mediolateral directions. Seventeen resistance-trained men, with 9.4±4.7 years of resistance training experience were recruited. After a familiarization session assessing 1 repetition maximum (RM) in the bench press, participants performed: 1) bench press with traditional stable loading 2) bench press with loads (2x5kg) attached as pendulums swinging forward/backwards and 3) left/right in randomized order. The total load was 70% of the 1RM load. Electromyography was measured in the pectoralis major, anterior- and posterior deltoid, biceps brachii, triceps brachii and external obliques. Using stable loads, the pectoralis major demonstrated lower EMG amplitude compared to the two unstable conditions. In the external obliques, the stable conditions demonstrated lower EMG amplitude than the swing in the mediolateral direction, but not the anteroposterior direction. There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid. In conclusion, swinging in bench press resulted in similar EMG amplitude in the shoulder- and arm muscles, but greater pectoralis and external oblique (only mediolateral swing) activity compared to bench press.",2020,"There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid.","['Seventeen resistance-trained men, with 9.4±4.7 years of resistance training experience were recruited']",['traditional stable loading 2) bench press with loads (2x5kg) attached as pendulums swinging forward/backwards and 3) left/right'],"['triceps brachii, biceps brachii, anterior deltoid or posterior deltoid', 'EMG amplitude', 'similar EMG amplitude', 'pectoralis and external oblique (only mediolateral swing) activity', 'total load']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0224375', 'cui_str': 'External Oblique Muscle'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0222778,"There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid.","[{'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Tom Erik Jorung', 'Initials': 'TEJ', 'LastName': 'Solstad', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Matthew Peter', 'Initials': 'MP', 'LastName': 'Shaw', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}]",PloS one,['10.1371/journal.pone.0239202']
2721,32946574,Pharmacodynamic Activity of the Novel Neurokinin-3 Receptor Antagonist SJX-653 in Healthy Men.,"CONTEXT


SJX-653 is a novel neurokinin 3 receptor (NK3R) antagonist. The NK3 pathway is a central regulator of gonadotropin releasing hormone (GnRH) secretion and has also been implicated in the generation of hot flashes. Therefore, decreases of luteinizing hormone (LH) and testosterone in men serve as sensitive pharmacodynamic (PD) markers of central NK3 antagonism.
OBJECTIVE


To characterize the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of SJX-653 in healthy men.
DESIGN


A randomized, placebo-controlled, double-blind, single ascending dose study.
SETTING


Phase 1 unit.
PATIENTS OR OTHER PARTICIPANTS


Seven cohorts of 6 healthy men 18-45 years of age (4:2 randomization to SJX-653/placebo per cohort).
INTERVENTION(S)


Single oral doses of 0.5-90 mg SJX-653.
MAIN OUTCOME MEASURE(S)


Safety assessments and serial pharmacokinetic (PK)/PD measurements.
RESULTS


SJX-653 was well tolerated at all dose levels. Cmax and AUC0-24 increased in a dose-proportional manner. The terminal elimination half-life ranged between 9.8 and 12.5 hours independent of dose. A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg. Maximal LH reduction was 70 ± 7% (mean ± sd) at 6 hours after 30 mg SJX-653 versus 10 ± 43% for placebo (P = 0.0006); maximal T reduction was of 68 ± 5% at 8 hours after 60 mg SJX-653 versus 18 ± 11% for placebo (P < 0.0001). The plasma IC50 for LH reduction was 33 ng/mL.
CONCLUSIONS


These data demonstrate clinical proof-of-mechanism for SJX-653 as a potent centrally-acting NK3R antagonist.",2020,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","['Phase 1 unit', 'healthy men', 'Seven cohorts of 6 healthy men 18-45 years (4:2 randomization to SJX-653/placebo per cohort']","['placebo', 'SJX-653', 'novel neurokinin-3 receptor antagonist SJX-653']","['LH and testosterone', 'Safety assessments and serial Pharmacokinetic (PK)/PD measurements', 'Maximal LH reduction', 'plasma IC50 for LH reduction', 'Pharmacodynamic activity', 'Cmax and AUC0-24', 'tolerated', 'safety, tolerability, pharmacokinetics, and pharmacodynamic activity', 'maximal T reduction']","[{'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0600495', 'cui_str': 'IC50'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.170922,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cormier', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thieroff-Ekerdt', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Boyce', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'van den Berg', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grau', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turnquist', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Deya', 'Initials': 'D', 'LastName': 'Corzo', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Graham', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa657']
2722,32946590,Periodontal regeneration using a xenogeneic bone substitute seeded with autologous periodontal ligament-derived mesenchymal stem cells: A 12-month quasi-randomized controlled pilot clinical trial.,"AIM


To evaluate the safety and efficacy of autologous periodontal ligament-derived mesenchymal stem cells (PDL-MSCs) embedded in a xenogeneic bone substitute (XBS) for the regenerative treatment of intra-bony periodontal defects.
MATERIAL AND METHODS


This quasi-randomized controlled pilot phase II clinical trial included patients requiring a tooth extraction and presence of one intra-bony lesion (1-2 walls). Patients were allocated to either the experimental (XBS + 10 × 10 6  PDL-MSCs/100 mg) or the control group (XBS). Clinical and radiographical parameters were recorded at baseline, 6, 9 and 12 months. The presence of adverse events was also evaluated. Chi-square, Student's t test, Mann-Whitney U, repeated-measures ANOVA and regression models were used.
RESULTS


Twenty patients were included. No serious adverse events were reported. Patients in the experimental group (n = 9) showed greater clinical attachment level (CAL) gain (1.44, standard deviation [SD] = 1.87) and probing pocket depth (PPD) reduction (2.33, SD = 1.32) than the control group (n = 10; CAL gain = 0.88, SD = 1.68, and PPD reduction = 2.10, SD = 2.46), without statistically significant differences.
CONCLUSION


The application of PDL-MSCs to XBS for the treatment of one- to two-wall intra-bony lesions was safe and resulted in low postoperative morbidity and appropriate healing, although its additional benefit, when compared with the XBS alone, was not demonstrated.",2020,"Patients in the experimental group (n=9) showed greater clinical attachment level (CAL) gain [1.44, standard deviation (SD)=1.87] and probing pocket depth (PPD) reduction (2.33, SD=1.32) than the control group (n=10; CAL","['patients requiring a tooth extraction and presence of one intra-bony lesion (1-2 walls', 'Twenty patients were included']","['autologous periodontal ligament-derived mesenchymal stem cells (PDL-MSCs', 'experimental (XBS + 10x10 6  PDL-MSCs/100mg) or the control group (XBS', 'Xenogeneic Bone Substitute seeded with Autologous Periodontal Ligament derived Mesenchymal Stem Cells', 'CAL']","['safety and efficacy', 'adverse events', 'clinical attachment level (CAL) gain', 'probing pocket depth (PPD) reduction', 'Clinical and radiographical parameters', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227089', 'cui_str': 'Structure of deciduous maxillary right second molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.0751446,"Patients in the experimental group (n=9) showed greater clinical attachment level (CAL) gain [1.44, standard deviation (SD)=1.87] and probing pocket depth (PPD) reduction (2.33, SD=1.32) than the control group (n=10; CAL","[{'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Sánchez', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Fierravanti', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vignoletti', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'González-Zamora', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Santamaría', 'Affiliation': 'Margarita Salas Center for Biological Research (CIB-CSIC), Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Suárez-Sancho', 'Affiliation': 'GMP-Cell Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Red de Terapia Celular (TERCEL) and CIBER Cardiovascular (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Fernández-Santos', 'Affiliation': 'GMP-Cell Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Red de Terapia Celular (TERCEL) and CIBER Cardiovascular (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Figuero', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herrera', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'García-Sanz', 'Affiliation': 'Margarita Salas Center for Biological Research (CIB-CSIC), Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}]",Journal of clinical periodontology,['10.1111/jcpe.13368']
2723,32946612,"Intradermal Phleum pratense allergoid immunotherapy. Double-blind, randomized, placebo-controlled trial.","BACKGROUND


In allergology, the intradermal approach is generally used to establish an aetiological diagnosis, with limited experience in specific allergen immunotherapy.
OBJECTIVE


To evaluate the efficacy and safety of immunotherapy with an allergen extract of glutaraldehyde-polymerized Phleum pratense, administered intradermally, in patients with rhinoconjunctivitis sensitized to grass pollen.
METHODS


Multicentre, randomized, double-blind, placebo-controlled clinical trial in patients from 12 to 65 years of age with rhinitis or rhinoconjunctivitis, with or without asthma, due to grass pollen allergy. Patients were divided into three groups and received a total of six doses in a weekly interval, of either placebo; 0.03 or 0.06 μg of protein per dose of P pratense allergoid. The primary objective was to evaluate the combined symptoms and medication consumption score (CSMS). The secondary objectives were symptoms and medication, tolerance to the conjunctival provocation test, specific IgE and IgG4 antibodies and the safety profile according to the WAO scale.
RESULTS


The dose of 0.06 μg of protein proved to be effective versus the placebo by significantly reducing CSMS and increasing tolerance to the allergenic extract in the conjunctival provocation test, after the first pollen season. This group showed a significant reduction in specific IgE after the second pollen season relative to the baseline. There were no variations in IgG4 levels. Only one grade 2 systemic reaction was recorded.
CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.",2020,"CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P. pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.","['patients from 12 to 65 years of age with rhinitis or rhinoconjunctivitis, with or without asthma, due to grass pollen allergy', 'patients with rhinoconjunctivitis sensitized to grass pollen']","['glutaraldehyde-polymerised Phleum pratense', 'immunotherapy', 'placebo; 0.03 μg or 0.06 μg of protein per dose of Phleum pratense allergoid', 'placebo', 'Intradermal Phleum pratense allergoid immunotherapy']","['grade 2 systemic reaction', 'combined symptoms and medication consumption score (CSMS', 'efficacy and safety', 'IgG4 levels', 'symptoms and medication, tolerance to the conjunctival provocation test, specific IgE and IgG4 antibodies and the safety profile according to the WAO scale', 'specific IgE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0740919', 'cui_str': 'Allergy to grass pollen'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}]","[{'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C1123001', 'cui_str': 'Phleum pratense'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0051199', 'cui_str': 'Allergoid'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0430565', 'cui_str': 'Ophthalmic mucous membrane test'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.45433,"CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P. pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Sola Martínez', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Ruth María', 'Initials': 'RM', 'LastName': 'Barranco Jiménez', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín García', 'Affiliation': 'Hospital Virgen de la Concha, Zamora, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Senent Sánchez', 'Affiliation': 'Hospital Virgen del Valle, Toledo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco Guerra', 'Affiliation': 'Hospital Universitario de La Princesa, Instituto de investigación Sanitaria Princesa, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'RETIC ARADyAL, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Vega Castro', 'Affiliation': 'RETIC ARADyAL, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Dávila González', 'Affiliation': 'RETIC ARADyAL, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carbonell Martínez', 'Affiliation': 'Hospital General Universitario Reina Sofía, Murcia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Panizo Bravo', 'Affiliation': 'Hospital Virgen del Prado, Talavera de la Reina, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gómez Torrijos', 'Affiliation': 'Hospital Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Gil', 'Affiliation': 'Diater Laboratorios S.A, Leganés, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios Peláez', 'Affiliation': 'Diater Laboratorios S.A, Leganés, Madrid, Spain.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13740']
2724,32949918,A high-protein meal does not improve blood pressure or vasoactive biomarker responses to acute exercise in humans.,"Blood pressure (BP) responses to exercise yield prognostic information beyond resting BP. While habitual higher dietary protein intake is associated with reduced resting BP, few studies have assessed the impact of high-protein meals on acute BP and vasoactive biomarker responses to exercise. To test the hypothesis that consuming a higher-protein, lower fat meal (HP; 30 g protein, 17 g fat, 52 g carbohydrate) would attenuate the BP response to exercise and result in a more robust post-exercise hypotensive response compared to a lower-protein, higher-fat meal (LP; 13 g protein, 25 g fat, 54 g carbohydrate), we recruited 31 pre-hypertensive subjects to complete this randomized, double-blind, cross-over acute feeding study. One hundred sixty-five minutes after consuming the test HP or LP meal, subjects exercised on a cycle ergometer at 70% VO 2  max for 30 minutes. Blood pressure was measured prior to the meal and periodically before, during, and after exercise for a 315-minute period. Blood samples were periodically collected to quantify plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites in a subset of subjects (n = 15) as shown in Supplemental Table S1. Consuming the HP meal did not influence the BP responses to exercise, including the post-exercise return to baseline BP or systolic BP area under the curve. While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered. These results suggest that consuming a higher-protein, lower-fat meal does not influence BP or vasoactive biomarker responses to exercise compared to a lower-protein, higher-fat meal.",2020,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","['humans', '31 pre-hypertensive subjects']","['carbohydrate', 'HP meal']","['postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites', 'plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites', 'BP responses', 'post-exercise return to baseline BP or systolic BP area under the curve', 'blood pressure or vasoactive biomarker responses', 'Blood pressure', 'BP response', 'Blood pressure (BP) responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.037945,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bergia', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907. Electronic address: campbellw@purdue.edu.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Roseguini', 'Affiliation': 'Department of Health & Kinesiology, Purdue University, 800 W Stadium Ave, West Lafayette, IN 47907.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Food Science and Technology Programme, c/o Department of Chemistry, National University of Singapore, 3 Science Drive 3, Singapore 117543. Electronic address: chmkje@nus.edu.sg.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.001']
2725,32910476,Higher serum PD-L1 level predicts increased overall survival with lapatinib versus trastuzumab in the CCTG MA.31 phase 3 trial.,"BACKGROUND


The purpose of this retrospective biomarker study of the Canadian Cancer Trials Group (CCTG) MA.31 randomized phase 3 trial (lapatinib vs trastuzumab) of HER2-positive metastatic breast cancer (MBC) was to evaluate the prognostic and predictive biomarker utility of pretreatment serum programmed death ligand 1 (PD-L1) levels.
METHODS


CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm). The Ella immunoassay platform (ProteinSimple, San Jose, California) was used to quantitate serum PD-L1 levels. Stepwise forward Cox multivariable analyses were performed for progression-free survival and overall survival (OS).
RESULTS


In the whole trial population, continuous pretreatment serum PD-L1 levels were not associated with OS. However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37). In the whole trial, in a multivariable analysis for OS, serum PD-L1 (median cut point) remained a significant independent covariate (HR, 2.38; P = .001). There was a significant interaction between treatment arm and continuous serum PD-L1 (bootstrap method; P = .0025): at or above 214.2 pg/mL (the 89th percentile), serum PD-L1 was associated with significantly shorter OS with trastuzumab treatment versus lapatinib treatment.
CONCLUSIONS


In the CCTG MA.31 trial, serum PD-L1 was a significant predictive factor: a higher pretreatment serum PD-L1 level was associated with shorter OS with trastuzumab treatment but with longer OS with lapatinib treatment. Immune evasion may decrease the effectiveness of trastuzumab therapy. Further evaluation of elevated serum PD-L1 in advanced breast cancer is warranted to identify patients with HER2-positive MBC who may benefit from novel immune-targeted therapies in addition to trastuzumab.",2020,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","['CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm', 'HER2-positive metastatic breast cancer (MBC', 'patients with HER2-positive MBC']","['lapatinib versus trastuzumab', 'lapatinib vs trastuzumab']","['serum PD-L1', 'progression-free survival and overall survival (OS', 'serum PD-L1 levels', 'serum PD-L1 level', 'overall survival']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",652.0,0.0795987,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","[{'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Moku', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Suhail M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Leitzel', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Nomikos', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aparicio', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Drabick', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cream', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'E Scott', 'Initials': 'ES', 'LastName': 'Halstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Umstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mckeone', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Polimera', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Maddukuri', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Aamnah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Nagabhairu', 'Affiliation': 'Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Poulose', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pancholy', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'ProteinSimple, San Jose, California.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lipton', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.33149']
2726,32910478,Results of an early safety analysis of a study of the combination of pembrolizumab and pelvic chemoradiation in locally advanced cervical cancer.,"BACKGROUND


Immune checkpoint inhibitors are being considered for locally advanced cervical cancer (LACC) together with standard-of-care pelvic chemoradiation (CRT). However, the safety of the combination and its optimal schedule are unknown. Defining the safety of the combination is a primary objective of a study examining concurrent and sequential schedules. This article presents a safety analysis that was fully accrued and met reporting requirements.
METHODS


Pembrolizumab was given after CRT (arm 1) or during CRT (arm 2) according to a randomized phase 2 design. Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system) were randomized 1:1 to the treatment regimens. The CRT was identical in the 2 arms. Pembrolizumab was administered every 3 weeks for 3 doses; no maintenance was allowed. All patients receiving any treatment were evaluated for safety. Safety assessments included the incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT) through 30 days after the last pembrolizumab infusion.
RESULTS


As of August 2019, 52 of the 88 planned patients had completed treatment and were evaluable for toxicity. Treatment-related grade 2 or higher toxicity was experienced by 88%; 11 had at least 1 grade 4 AE, and another 23 had at least 1 grade 3 AE. Grade 1 or higher diarrhea was reported in 34 patients (65%; 50% of these were grade 1), and there was no difference between arms (63% in arm 1 vs 68% in arm 2). Two patients experienced 3 DLTs. Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
CONCLUSIONS


Preliminary results support the safety and feasibility of adding pembrolizumab to pelvic CRT concurrently or sequentially.
LAY SUMMARY


Pembrolizumab is a humanized antibody against programmed cell death protein 1 that is used in cancer immunotherapy. Preliminary data suggest that pembrolizumab can be safely combined with chemotherapy and pelvic radiation in the treatment of locally advanced cervical cancer. Future studies of the addition of immunotherapy to traditional chemoradiation are planned to determine the best way to deliver the treatment and whether any improvement is seen with the addition of immunotherapy to traditional therapy.",2020,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","['locally advanced cervical cancer', 'Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system']","['pembrolizumab and pelvic chemoradiation', 'pembrolizumab', 'cisplatin', 'chemotherapy and pelvic radiation', 'Pembrolizumab']","['Grade 1 or higher diarrhea', 'toxicity', 'incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.105333,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scalici', 'Affiliation': 'Mitchell Cancer Institute, USA Health, Mobile, Alabama.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Temkin', 'Affiliation': 'Anne Arundel Medical Center, Annapolis, Maryland.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Schwarz', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Crane', 'Affiliation': 'Division of Gynecologic Oncology, Levine Cancer Institute, Charlotte, North Carolina.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, Virginia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Wethington', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Nikole E', 'Initials': 'NE', 'LastName': 'Varhegyi', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Sheena H', 'Initials': 'SH', 'LastName': 'Clift', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N J', 'Initials': 'TNJ', 'LastName': 'Bullock', 'Affiliation': 'Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Showalter', 'Affiliation': 'Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.33136']
2727,32911627,"Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.","Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high.",2020,The results obtained did not suggest any clear adherence difference between Arm A and Arm B.,"['mCRPC patients receiving', 'Patients with Metastatic Castration-Resistant Prostate Cancer Treated with', 'metastatic, castration-resistant prostate cancer (mCRPC) patients', 'patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization', 'mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B']","['abiraterone acetate plus prednisone', 'Residual androgen production', 'Abiraterone Acetate plus Prednisone', 'Abiraterone acetate (AA', 'mCRPC', 'AEM']","['discontinuation rates and medication adherence', 'rate of treatment discontinuation', 'medium/low Morisky Medication Adherence Scale (MMAS-4) score']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",360.0,0.0570704,The results obtained did not suggest any clear adherence difference between Arm A and Arm B.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Suttmann', 'Affiliation': 'Private Practice, Urologikum Hamburg, 22399 Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Gleissner', 'Affiliation': 'Private Practice, MVZ-DGU-Die GesundheitsUnion GmbH, 42103 Wuppertal, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huebner', 'Affiliation': 'Private Practice, Center for Oncology and Urology, 18107 Rostock, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mathes', 'Affiliation': 'Institut für Forschung in der Operativen Medizin, University Witten/Herdecke, 51109 Cologne, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Baurecht', 'Affiliation': 'Biometrics, Acromion GmbH, 50226 Frechen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Krützfeldt', 'Affiliation': 'Medical Affairs, Janssen-Cilag GmbH, 41470 Neuss, Germany.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Sweiti', 'Affiliation': 'Clinical Development, Janssen Research and Development LLC, Pennsylvania, PA 19477, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Private Practice Studienpraxis Urologie, 72622 Nürtingen, Germany.'}]",Cancers,['10.3390/cancers12092550']
2728,32911733,Impact of Short Foot Muscle Exercises on Quality of Movement and Flexibility in Amateur Runners.,"The flexibility and proper functioning of all myofascial chains are crucial for athletes, especially for long-distance runners. Due to the continuity of the myofascial structures, restrictions in one part of the body may cause excessive tension in others. The aim of our study was to evaluate the influence of short foot muscle exercises on muscle flexibility and the quality of movement patterns in amateur runners. Eighty long-distance runners, aged 20-45, were randomly divided into two groups: Group 1 ( n  = 48) and Group 2 ( n  = 32). Participants in Group 1 performed foot exercises daily for six weeks. Subjects in Group 2 were without any intervention. At baseline and after six weeks, the quality of movement patterns with the Functional Movement Screen and muscle flexibility was evaluated. In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks. The total score increased from 17 to 18 points (Median (Me) ± half of interquartile range (IQR/2) (Standard Error of Measurement - SEM) 17 ± 1.5 (0.23) at baseline and 18 ± 1.5 (0.24) after six weeks) ( p  < 0.01), whereas in Group 2, its level remained at 16 points (Me ± IQR/2 (SEM) 16 ± 1.5 (0.31) at baseline and 16 ± 1.25 (0.31) after six weeks). In Group 1, the significant improvement in muscle flexibility was noted (e.g., results for external rotation muscles: (Mean ± SD (SEM) 60.3 ± 0.4 (1.50) at baseline and 62.4 ± 10.3 (1.49) after six weeks) ( p  = 0.005). In Group 2, significant improvement was observed only for one task in the Active straight leg raise test ( p  = 0.005 and 0.02). During the measurement of external rotation muscles, a significant decrease in flexibility was observed (Mean ± SD (SEM) 60.1 ± 9.0 (1.60) at baseline and 58.0 ± 8.5 (1.51) after six weeks) ( p  = 0.001). Plantar short foot muscle exercises may improve muscle flexibility in the upper parts of the body within myofascial chains and influence the quality of fundamental movement patterns. Such exercises may be beneficial for all physically active people and can be performed as part of overall fitness programmes. Moreover, including such exercises in daily training routines of long-distance runners, as well as by athletes in other sport disciplines is also recommended.",2020,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","['Eighty long-distance runners, aged 20-45', 'amateur runners', 'Amateur Runners']","['short foot muscle exercises', 'Plantar short foot muscle exercises', 'Short Foot Muscle Exercises']","['quality of movement patterns with the Functional Movement Screen and muscle flexibility', 'total score', 'flexibility', 'Quality of Movement and Flexibility', 'external rotation muscles', 'muscle flexibility and the quality of movement patterns', 'muscle flexibility', 'Active straight leg raise test']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}]",80.0,0.0325762,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","[{'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Sulowska-Daszyk', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mika', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Oleksy', 'Affiliation': 'Physiotherapy and Sports Centre, Rzeszow University of Technology, 35-959 Rzeszow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186534']
2729,32912989,Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol.,"INTRODUCTION


Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgical procedure election. Furthermore, it is also necessary to establish the mechanisms by which LDL cholesterol improves after surgery and whether qualitative and quantitative changes occur in the different lipoprotein subclasses. The first objective is to ascertain whether high LDL cholesterol levels before surgery can be considered an additional factor when selecting the most appropriate surgical procedure for each patient (gastric bypass or sleeve gastrectomy). Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared. Secondary objectives were (1) to compare changes in other lipoproteins and LDL composition and (2) to study the pathophysiologic mechanisms related to LDL cholesterol remission.
METHODS AND ANALYSIS


A randomised clinical trial, with intention-to-treat analysis, will be conducted to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy, with a 12-month follow-up. Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40 kg/m 2  or ≥35 kg/m 2  with significant obesity-related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Parc de Salut Mar Ethics Committee (2019/8471/I). The study and its conclusions regarding the primary and secondary objectives will be presented as manuscripts submitted for peer-reviewed journal publication.
TRIAL REGISTRATION NUMBER


NCT03975478.",2020,"Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared.","['patients with morbid obesity', 'Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40']","['gastric bypass versus sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy', 'Bariatric surgery and LDL cholesterol']","['low-density lipoprotein (LDL) cholesterol improvement', 'routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation', 'LDL cholesterol remission', '1-year remission rates of high LDL cholesterol', 'obesity-related comorbidity and high LDL cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005774', 'cui_str': 'Blood chemistry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0811776,"Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benaiges', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain 96002@parcdesalutmar.cat.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Juana A', 'Initials': 'JA', 'LastName': 'Flores-Le Roux', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': ""Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Pozo', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodríguez-Morató', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Serra', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pera', 'Affiliation': 'Department of General Surgery, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Llauradó', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Elisenda', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': ""Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ramon', 'Affiliation': 'Department of General Surgery, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pedro-Botet', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-037712']
2730,32903263,"Mental fatigue impairs physical activity, technical and decision-making performance during small-sided games.","The aim of this study was to investigate the effects of mental fatigue on physical activity, technical and decision-making performance during small-sided games. Nine sub-elite soccer players were enrolled in the study. The players performed two small-sided games on two occasions within a crossover experimental design. Before each game, they underwent a mental fatiguing task (Stroop task) and a control task (documentary watching) in a randomized, counterbalanced order. Players' physical activity, technical, and decision-making performance were obtained during small-sided games by GPS and video scouting. Results showed that distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy were likely impaired than control task after a mental fatiguing protocol. Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task. These findings demonstrated that mental fatigue impacted on technical, GPS-derived, and soccer-specific decision-making performance during SSG. In conclusion, avoiding cognitively demanding tasks before playing soccer-specific activities may be advisable to preserve players' physical activity, technical, and decision-making skills.",2020,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.",['Nine sub-elite soccer players'],['mental fatiguing task (Stroop task) and a control task (documentary watching'],"[""Players' physical activity, technical, and decision-making performance"", 'distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy', 'Mental fatigue impairs physical activity, technical and decision-making performance', 'physical activity, technical and decision-making performance']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0335694,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.","[{'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Boccolini', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biotechnology and Life Sciences (DBSV), University of Insubria, Varese, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}]",PloS one,['10.1371/journal.pone.0238461']
2731,32918419,Improving cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device for healthcare providers in an emergency department setting in Malaysia: a quasi-experimental study.,"INTRODUCTION


Cardiopulmonary Resuscitation (CPR) remains the primary mechanism of resuscitation for cardiac arrest victims. However, the quality of delivery of CPR varies widely in different settings, possibly affecting patient outcomes. This study is aimed to determine the efficacy of an audio-visual (AV) CPR feedback device in improving the quality of CPR delivered by healthcare providers.
METHODS


This pre-post, single-arm, quasi-experimental study randomly sampled 140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia. Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device. The efficacy of the AV CPR feedback device was assessed using the Chi-square test and Generalised Estimating Equations (GEE) models.
RESULTS


The use of an AV CPR feedback device increased the proportion of healthcare providers achieving recommended depth of chest compressions from 38.6% (95% Confidence Interval, 95%CI: 30.5, 47.2) to 85.0% (95%CI: 78.0, 90.5). A similar significant improvement from 39.3% (95%CI: 31.1, 47.9) to 86.4% (95%CI: 79.6, 91.6) in the recommended rate of chest compressions was also observed. Use of the AV CPR device significantly increased the likelihood of a CPR provider achieving recommended depth of chest compressions (Odds Ratio, OR=13.01; 95%CI: 7.12, 24.01) and rate of chest compressions (OR=13.00; 95%CI: 7.21, 23.44).
CONCLUSION


The use of an AV CPR feedback device significantly improved the delivered rate and depth of chest compressions closer to American Heart Association (AHA) recommendations. Usage of such devices within real-life settings may help in improving the quality of CPR for patients receiving CPR.",2020,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","['patients receiving CPR', '140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia', 'healthcare providers in an emergency department setting in Malaysia']","['AV CPR feedback device', 'cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device', 'AV CPR device', 'Cardiopulmonary Resuscitation (CPR', 'audio-visual (AV) CPR feedback device']","['rate of chest compressions', 'AV CPR feedback device', 'CPR quality, namely chest compression rate and depth', 'quality of CPR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",140.0,0.03837,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chelladurai', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Noor Azhar', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mohd Isa', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bustam', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Munisamy', 'Affiliation': 'Chulalongkorn University, College of Public Health Sciences, Bangkok, Thailand. murallimd@gmail.com.'}]",The Medical journal of Malaysia,[]
2732,32918434,Resistant hypertension during antituberculosis treatment: how is rifampicin implicated?,"A 67-year-old mental institute resident was treated for smear-positive pulmonary tuberculosis. His background history included chronic essential hypertension which was well-controlled with amlodipine 10mg daily. However, his blood pressure became suboptimal one week into antitubercular treatment, necessitating escalation of antihypertensive therapy up to six medications. Following completion of antitubercular treatment, his blood pressure improved markedly. The number of antihypertensives was able to be reduced to only two after a month. We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.",2020,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,['His background history included chronic essential hypertension'],"['amlodipine', 'rifampicin']","['number of antihypertensives', 'blood pressure']","[{'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0273169,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Lee', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Lim', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chai', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia. chaishuteng@gmail.com.'}]",The Medical journal of Malaysia,[]
2733,32916792,Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial.,"Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.",2020,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","['30 people with', 'people with diabetic neuropathy (DPN', 'people at risk of diabetic foot disease', 'People with Diabetic Neuropathy', '45 eligible participants (0.90/week']","['foot-ankle exercise program', 'DPN to usual care (control) or usual care plus a supervised exercise program (intervention', 'Foot-ankle strengthening and mobility exercises', 'Foot-Ankle Exercise Program']","['daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests', 'Program adherence', 'heel peak pressures and force', 'recruitment rate and participant adherence and satisfaction', 'clinical, functional and biomechanical outcomes', 'toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}]",45.0,0.0840922,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","[{'ForeName': 'Renan L', 'Initials': 'RL', 'LastName': 'Monteiro', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jane S S P', 'Initials': 'JSSP', 'LastName': 'Ferreira', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Érica Q', 'Initials': 'ÉQ', 'LastName': 'Silva', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Donini', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Ronaldo H', 'Initials': 'RH', 'LastName': 'Cruvinel-Júnior', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jady L', 'Initials': 'JL', 'LastName': 'Verissímo', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Sicco A', 'Initials': 'SA', 'LastName': 'Bus', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185129']
2734,32916983,Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms.,"BACKGROUND


The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger.
METHODS


In this randomized controlled trial, the usual monitoring method (i.e., onsite;  n  = 44) was compared with daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms ( n  = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study.
RESULTS


With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms.
CONCLUSIONS


The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.",2020,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).",['patients with chronic musculoskeletal pain'],"['daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms', 'Pain Monitor mobile phone application (app', 'Telemonitoring', 'usual treatment with an app without alarms and usual treatment with an app with alarms']","['pain severity and interference, fatigue, depressed mood, anxiety and anger']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",,0.0691226,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Assessment, and Psychological Treatments, Universidad de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragozá', 'Affiliation': 'Ciber Fisiopatologia Obesidad y Nutricion (CB06/03 Instituto Salud Carlos III) (Ciber Physiopathology Obesity and Nutrition, CB06/03 Instituto Salud Carlos III Health Institute), 28029 Madrid, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Mesas', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Server', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Medel', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186568']
2735,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2736,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2737,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE


The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY


To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS


This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS


The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2021,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Márcia Viana', 'Initials': 'AMV', 'LastName': 'Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique Soares', 'Initials': 'GHS', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa Maria da Silva', 'Initials': 'EMDS', 'LastName': 'Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita de Cássia Matos', 'Initials': 'RCM', 'LastName': 'Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'Fabrício Mesquita', 'Initials': 'FM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
2738,32929822,Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis.,"People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.",2020,Intervention patients also experienced improved quality of life.,"['people with decompensated cirrhosis', 'patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n =\u200957) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n =\u200959', 'People with chronic disease']",['patient-oriented education and medication management intervention'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.102154,Intervention patients also experienced improved quality of life.,"[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Hayward', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Valery', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Preya J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leigh U', 'Initials': 'LU', 'LastName': 'Horsfall', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Wright', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Tallis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Stuart', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Irvine', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Cottrell', 'Affiliation': 'Macrophage Biology Research Group, Mater Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Powell', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}]",Internal medicine journal,['10.1111/imj.14986']
2739,32950115,Effectiveness of a nurse-led physical activity intervention to decrease cardiovascular disease risk in middle-aged adults: A pilot randomized controlled study.,"The purpose of this study was to evaluate the effectiveness of the nurse-led physical activity (PA) intervention on cardiovascular disease (CVD) risk reduction in individuals with moderate risk. A randomized controlled pilot trial was conducted with 12 individuals who have moderate cardiovascular risk meeting the inclusion criteria. Eleven individuals in the intervention group participated in a 12-week PA program (outdoor group walking with the group 5 days in a week, each lasting for 40 minutes) guided by a nurse. For determining the risk level of CVD, the ""HeartScore program"" was used. Height, weight, blood pressure, and cholesterol values of individuals in the intervention group were measured. At the end of nurse-led outdoor walking activity with the group for 12 weeks, systolic blood pressure (P = .041) and cholesterol (P = .001) values of individuals in the intervention group decreased based on the baseline levels and accordingly CVD risk levels decreased significantly (P = .019). There was no significant difference in the control group. This study demonstrates that health care professionals working in the family health centers can easily determine the CVD risk with the HeartScore. Outdoor group walking program guided by a nurse is effective in decreasing the CVD risk level.",2020,There was no significant difference in the control group.,"['individuals with moderate risk', 'middle-aged adults', '12 individuals who have moderate cardiovascular risk meeting the inclusion criteria']","['nurse-led physical activity intervention', 'nurse-led physical activity (PA) intervention', 'PA program (outdoor group walking with the group 5\xa0days in a week, each lasting for 40\xa0minutes) guided by a nurse']","['outdoor walking activity', 'CVD risk level', 'cardiovascular disease risk', 'CVD risk levels', 'systolic blood pressure', 'Height, weight, blood pressure, and cholesterol values', 'cardiovascular disease (CVD) risk reduction', 'cholesterol']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0253268,There was no significant difference in the control group.,"[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Dağistan Akgöz', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey. Electronic address: aysedagistan@akdeniz.edu.tr.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Gözüm', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.05.002']
2740,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
2741,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
2742,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
2743,32951337,Validation of the clinical applicability of knowledge-based planning models in single-isocenter volumetric-modulated arc therapy for multiple brain metastases.,"PURPOSE


To validate the clinical applicability of knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT) for multiple brain metastases using the k-fold cross-validation (CV) method.
METHODS


This study comprised 60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28 Gy in five fractions). The patients were divided randomly into five groups (Groups 1-5). The data of Groups 1-4 were used as the training and validation dataset and those of Group 5 were used as the testing dataset. Four KB models were created from three of the training and validation datasets and then applied to the remaining Groups as the fourfold CV phase. As the testing phase, the final KB model was applied to Group 5 and the dose distributions were calculated with a single optimization process. The dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan were compared to those of the clinical plan (CL) using a paired Wilcoxon signed-rank test.
RESULTS


In the fourfold CV phase, no significant differences were observed in the DVIs among the four KB plans (KBPs). In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs) D 2%  and D 50%  . The differences between the CL and KBP in terms of the PTV D 99.5%  , normal brain, and D max  to all organs at risk (OARs) were not significant. The KBP achieved a lower total number of MUs and higher MCSv than the CL with no significant difference.
CONCLUSIONS


We demonstrated that a KB model in a single-isocenter VMAT for multiple brain metastases was equivalent in dose distribution, MCSv, and total number of MUs to a CL with a single optimization.",2020,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","['multiple brain metastases', '60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28\xa0Gy in five fractions']",['knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT'],"['total number of MUs and higher MCSv', 'dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan', 'normal brain, and D max  to all organs at risk (OARs', 'planning target volumes (PTVs']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]",60.0,0.0117103,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kishi', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hirashima', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Mukumoto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Takehana', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Uto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Matsuo', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizowaki', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Journal of applied clinical medical physics,['10.1002/acm2.13022']
2744,32917300,Fit to Study: Reflections on designing and implementing a large-scale randomized controlled trial in secondary schools.,"BACKGROUND


The randomised controlled trial (RCT) design is increasingly common among studies seeking good-quality evidence to advance educational neuroscience, but conducting RCTs in schools is challenging. Fit to Study, one of six such trials funded by the Education Endowment Foundation and Wellcome Trust, tested an intervention to increase vigorous physical activity during PE lessons on maths attainment among pupils aged 12-13. This review of designing and conducting an RCT in 104 schools is intended as a resource on which researchers might draw for future studies.
METHOD


We consider intervention design and delivery; recruitment, retention, trial management, data collection and analysis including ethical considerations and working with evaluators.
RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
CONCLUSION


Simple interventions, with few outcome measures and minimal missing data, are preferable to more complex designs.",2020,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","['pupils aged 12-13', '104 schools']",[],[],"[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],[],,0.112651,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wheatley', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU. Electronic address: catherine.wheatley@ndcn.ox.ac.uk.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Beale', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wassenaar', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Oxford Uehiro Centre for Practical Ethics, Wellcome Centre for Ethics and Humanities, University of Oxford, 6-17 St Ebbes St, Oxford OX1 1PT.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Eldridge', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Johansen-Berg', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}]",Trends in neuroscience and education,['10.1016/j.tine.2020.100134']
2745,32919388,Preterm children's long-term academic performance after adaptive computerized training: an efficacy and process analysis of a randomized controlled trial.,"BACKGROUND


Adaptive computerized interventions may help improve preterm children's academic success, but randomized trials are rare. We tested whether a math training (XtraMath®) versus an active control condition (Cogmed®; working memory) improved school performance. Training feasibility was also evaluated.
METHODS


Preterm born first graders, N = 65 (28-35 + 6 weeks gestation) were recruited into a prospective randomized controlled multicenter trial and received one of two computerized trainings at home for 5 weeks. Teachers rated academic performance in math, reading/writing, and attention compared to classmates before (baseline), directly after (post), and 12 months after the intervention (follow-up). Total academic performance growth was calculated as change from baseline (hierarchically ordered-post test first, follow-up second).
RESULTS


Bootstrapped linear regressions showed that academic growth to post test was significantly higher in the math intervention group (B = 0.25 [95% confidence interval: 0.04-0.50], p = 0.039), but this difference was not sustained at the 12-month follow-up (B = 0.00 [-0.31 to 0.34], p = 0.996). Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
CONCLUSIONS


Our findings do not show a sustained difference in efficacy between both trainings. Studies of math intervention effectiveness for preterm school-aged children are warranted.
IMPACT


Adaptive computerized math training may help improve preterm children's short-term school performance. Computerized math training provides a novel avenue towards intervention after preterm birth. Well-powered randomized controlled studies of math intervention effectiveness for preterm school-aged children are warranted.",2020,"Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
","['preterm school-aged children', 'Preterm born first graders, N\u2009=\u200965 (28-35\u2009+\u20096 weeks gestation', 'N\u2009=\u200927', ""preterm children's academic success""]","['IMPACT\n\n\nAdaptive computerized math training', 'math training (XtraMath®) versus an active control condition (Cogmed®; working memory', 'Computerized math training', 'GROUP (XTRAMATH (N\u2009=\u200929, BOLDED) VERSUS COGMED', 'adaptive computerized training']","['HIE hypoxic-ischemic encephalopathy, PVL periventricular leukomalacia, IVH intraventricular hemorrhage, ODD oppositional defiant disorder', 'higher acceptance', ""preterm children's short-term school performance"", 'school performance', 'Teachers rated academic performance in math, reading/writing, and attention compared to classmates', 'academic growth to post test', 'Total academic performance growth', ""Preterm children's long-term academic performance""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700132', 'cui_str': 'Academic Achievement'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0023529', 'cui_str': 'Periventricular leukomalacia'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.290526,"Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jaekel', 'Affiliation': 'Child and Family Studies | Psychology, University of Tennessee Knoxville, Knoxville, TN, USA. jjaekel@utk.edu.'}, {'ForeName': 'Katharina M', 'Initials': 'KM', 'LastName': 'Heuser', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': ""Vest Children's Hospital Datteln, University Witten-Herdecke, Datteln, Germany.""}, {'ForeName': 'Francisco Brevis', 'Initials': 'FB', 'LastName': 'Nuñez', 'Affiliation': 'Pädiatrische Intensivmedizin, Sana-Kliniken Duisburg, Duisburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bartmann', 'Affiliation': ""Children's Hospital, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Wolke', 'Affiliation': 'Psychology, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Felderhoff-Mueser', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Huening', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}]",Pediatric research,['10.1038/s41390-020-01114-w']
2746,32925971,Effectiveness of a mobile health intervention on uptake of recommended postnatal care services in Nigeria.,"Studies have linked the large percentage of maternal and neonatal mortality that occur in postnatal period to low uptake of postnatal care (PNC) services. Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies. However, its use in PNC services' uptake has not been adequately investigated in Nigeria. This study aimed to evaluate the effect of a mobile health intervention on PNC attendance among mothers in selected primary healthcare facilities in Osun State, Nigeria. A quasi-experimental research design was utilised. Participants were allocated to Intervention Group and Control Group. One hundred and ninety pregnant mothers were recruited in each group. A mobile health intervention software was developed and used to send educational and reminder messages to mothers in the intervention group from the 35th week of pregnancy to six weeks after delivery. Uptake of PNC services was assessed at birth, 3 days, 10 days and 42 days after delivery. Data were analysed using descriptive statistics, chi-square and logistic regression models. About one-third (30.9%) of respondents in the intervention group had four postnatal care visits while only 3.7% in the control group had four visits (p < 0.001). After controlling for the effect of confounding variables, group membership remained a significant predictor of PNC uptake. (AOR: 10.869, 95% CI: 4.479-26.374). Mobile health intervention significantly improved utilisation of the recommended four postnatal care visits.",2020,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"['mothers in selected primary healthcare facilities in Osun State, Nigeria', 'Nigeria', 'One hundred and ninety pregnant mothers']","['Mobile health (mHealth) intervention', 'mobile health intervention', 'Mobile health intervention', 'Intervention Group and Control Group']","['antenatal care utilisation', 'PNC uptake', 'PNC attendance', 'Uptake of PNC services', 'postnatal care visits']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",190.0,0.115177,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"[{'ForeName': 'Aanuoluwapo Omobolanle', 'Initials': 'AO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Boluwaji Reuben', 'Initials': 'BR', 'LastName': 'Fajemilehin', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Temitope Oluwafemi', 'Initials': 'TO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Family Medicine, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.'}, {'ForeName': 'Babajide Samuel', 'Initials': 'BS', 'LastName': 'Afolabi', 'Affiliation': 'Department of Computer Science, Obafemi Awolowo University, Ile-Ife, Nigeria.'}]",PloS one,['10.1371/journal.pone.0238911']
2747,32927858,Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial.,"Chronic neck pain is one of today's most prevalent pathologies. The International Classification of Diseases categorizes four subgroups based on patients' associated symptoms. However, this classification does not encompass upper cervical spine dysfunction. The aim is to compare the short- and mid-term effectiveness of adding a manual therapy approach to a cervical exercise protocol in patients with chronic neck pain and upper cervical spine dysfunction. Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise). Each group received four 20-min sessions, one per week during four consecutive weeks, and a home exercise regime. Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment were assessed at the beginning, end of the intervention and at 3- and 6-month follow-ups. The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group. Four 20-min sessions of Manual therapy + Exercise along with a home-exercise program is more effective in the short- to mid-term than an exercise protocol and a home-exercise program for patients with chronic neck pain and upper cervical dysfunction.",2020,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"['patients with chronic neck pain and upper cervical dysfunction', 'patients with chronic neck pain and upper cervical spine dysfunction', 'Patients with Chronic Neck Pain in Short- and Mid-Term', 'Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise']","['cervical exercise protocol', 'Cervical Exercise Program', 'exercise protocol and a home-exercise program', 'Manual therapy + Exercise', 'Manual therapy + Exercise along with a home-exercise program', 'manual therapy approach']","['Chronic neck pain', 'Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment', 'short- and medium-term']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",58.0,0.044157,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"[{'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Malo-Urriés', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-de-Toro', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'María Orosia', 'Initials': 'MO', 'LastName': 'Lucha-López', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Tricás-Moreno', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Lorente', 'Affiliation': 'Impact Laboratory, Aragón Institute of Engineering Research (I3A), Universidad de Zaragoza, 50018 Zaragoza, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186601']
2748,32932604,"Effect of a Combination of Myo-Inositol, Alpha-Lipoic Acid, and Folic Acid on Oocyte Morphology and Embryo Morphokinetics in non-PCOS Overweight/Obese Patients Undergoing IVF: A Pilot, Prospective, Randomized Study.","Herein we aimed at assessing whether Myo-Inositol (MI), Alpha-Lipoic acid (ALA), and Folic acid (FA) could improve oocyte quality and embryo development in non-PCOS overweight/obese women undergoing IVF. Three hundred and twenty-four mature oocytes were obtained from non-PCOS overweight/obese patients, randomized to receive either MI, ALA, and FA (MI + ALA + FA group,  n  = 155 oocytes) or FA alone (FA-only group,  n  = 169 oocytes). Oocytes were examined using Polarized Light Microscopy to assess morphological features of zona pellucida (ZP) and meiotic spindle (MS). One hundred and seventy-six embryos ( n  = 84 in the MI + ALA + FA group,  n  = 92 in the FA-only group) were assessed by conventional morphology on days 2 and 5, as well as using the Time-Lapse System morphokinetic analysis. A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality. Conventional morphology evaluation on day 2 showed a higher mean embryo score in the MI + ALA + FA group, whereas embryo morphokinetic was comparable in the two groups. Overall, our data show a possible beneficial effect of the combination of MI, ALA, and FA on oocyte and embryo morphology, encouraging testing of this combination in adequately powered randomized trials to assess their impact of clinical IVF results.",2020,"A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality.","['non-PCOS Overweight/Obese Patients Undergoing IVF', 'One hundred and seventy-six embryos ( n  = 84 in the', 'Three hundred and twenty-four mature oocytes were obtained from non-PCOS overweight/obese patients', 'non-PCOS overweight/obese women undergoing IVF']","['MI + ALA + FA', 'MI, ALA, and FA (MI + ALA + FA group,  n  ', 'FA alone (FA', 'Myo-Inositol (MI), Alpha-Lipoic acid (ALA), and Folic acid (FA', 'Combination of Myo-Inositol, Alpha-Lipoic Acid, and Folic Acid']","['ZP retardance, area, and thickness', 'shorter MS axis', 'oocyte quality and embryo development', 'morphological features of zona pellucida (ZP) and meiotic spindle (MS', 'mean embryo score', 'Oocyte Morphology and Embryo Morphokinetics', 'embryo morphokinetic', 'oocyte quality']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043519', 'cui_str': 'Zona Pellucida'}, {'cui': 'C3268864', 'cui_str': 'Meiotic Spindle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",324.0,0.0476783,"A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Paschero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Leoncini', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Mercaldo', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9092949']
2749,32935488,"Efficacy, Safety, and Immunomodulatory Effect of the Intramuscular Administration of Autologous Total Immunoglobulin G for Atopic Dermatitis: A Randomized Clinical Trial.","PURPOSE


The management of patients with atopic dermatitis (AD) is often difficult. We hypothesized that repeated intramuscular administration of autologous total immunoglobulin G (IgG) could induce clinical improvement in patients with AD through immune modulation. This clinical trial was conducted to evaluate the efficacy, safety, and immunomodulatory effect of the intramuscular administration of autologous total IgG in patients with AD.
METHODS


In this randomized, double-blind, placebo-controlled trial, 51 adolescent and adult patients with moderate-to-severe AD were randomized to receive 8 weekly intramuscular administrations of autologous total IgG 50 mg (n = 26) or saline (n = 25) over a 7-week period and were followed up to week 16. Changes in the clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events from baseline to week 16 were assessed.
RESULTS


The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  = 0.011 and  P  = 0.003, respectively), and reduced the incidence of AD exacerbation (11.5% vs. 48.0%,  P  = 0.004) from baseline to week 16. No serious adverse events were observed.
CONCLUSIONS


The intramuscular administration of autologous total IgG provided clinical improvements and a systemic immunomodulatory effect in adolescent and adult patients with moderate-to-severe AD without significant side effects.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0001597.",2020,"The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  ","['patients with AD through immune modulation', '51 adolescent and adult patients with moderate-to-severe AD', 'adolescent and adult patients with moderate-to-severe AD', 'patients with AD', 'patients with atopic dermatitis (AD', 'Atopic Dermatitis']","['Autologous Total Immunoglobulin G', 'autologous total IgG', 'autologous total IgG 50 mg (n = 26) or saline', 'placebo', 'autologous total immunoglobulin G (IgG']","['efficacy, safety, and immunomodulatory effect', 'clinical severity score', 'clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events', 'DLQI score', 'Efficacy, Safety, and Immunomodulatory Effect', 'affected body surface area', 'serum interleukin-10 and interferon-γ levels', 'incidence of AD exacerbation', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",51.0,0.470745,"The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  ","[{'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Nahm', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea. dhnahm@ajou.ac.kr.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Ye', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Yoo Seob', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hae Sim', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Myoung Eun', 'Initials': 'ME', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Byul', 'Initials': 'B', 'LastName': 'Kwon', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Cho', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jinjoo', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Office of Biostatistics, Institute of Medical Sciences, Ajou University School of Medicine, Suwon, Korea.'}]","Allergy, asthma & immunology research",['10.4168/aair.2020.12.6.949']
2750,32937839,Effects of Smoking and Smoking Cessation on the Intestinal Microbiota.,"We evaluated associations of smoking heaviness markers and the effects of smoking cessation on the intestinal microbiota and cardiovascular disease risk factors in current smokers undertaking a quit attempt. Participants were current smokers enrolled in a prospective randomized clinical trial of smoking cessation therapies with visits at baseline, 2, and 12 weeks. Genomic DNA was extracted from fecal samples followed by 16S rRNA gene sequencing and analysis using the QIIME2 software workflow. Relative abundances of bacterial taxa and alpha- and beta-diversity measures were used for comparisons. The 36 smokers were (mean (standard deviation)) 51.5 (11.1) years old (42% male) and smoked 15.1 (6.4) cigarettes per day for 22.7 (11.9) pack-years. Relative abundances of the phylum Actinobacteria correlated with pack-years (rho = -0.44,  p  = 0.008) and Cyanobacteria correlated with CO levels (rho = 0.39,  p  = 0.021). After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers. Increases in alpha-diversity were associated with heart rates (rho = -0.59,  p  = 0.037), systolic blood pressures (rho = -0.58,  p  = 0.043), and C-reactive protein (rho = -0.60,  p  = 0.034). Smoking cessation led to minor changes in the intestinal microbiota. It is unclear if the proven health benefits of smoking cessation lead to salutary changes in the intestinal microbiota.",2020,"After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers.","['51.5 (11.1) years old (42% male) and smoked 15.1 (6.4) cigarettes per day for 22.7 (11.9) pack-years', '36 smokers were (mean (standard deviation']","['Smoking and Smoking Cessation', 'smoking cessation']","['systolic blood pressures', 'Cyanobacteria correlated with CO levels', 'relative abundances of the phylum Bacteroidetes', 'Relative abundances of bacterial taxa and alpha- and beta-diversity measures', 'alpha-diversity', 'heart rates']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1047211', 'cui_str': 'Cyanobacteria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",42.0,0.0184073,"After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers.","[{'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Sublette', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Tzu-Wen L', 'Initials': 'TL', 'LastName': 'Cross', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, 47907, USA.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Hansen', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Sofia M', 'Initials': 'SM', 'LastName': 'Murga-Garrido', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Madeline K', 'Initials': 'MK', 'LastName': 'Oguss', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Rey', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092963']
2751,32945733,Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?,"BACKGROUND


Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient's concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well.  Methods:  Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control.  Results:  Both groups had very high patient satisfaction scores; there was no statistical difference between them.  Conclusions:  Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.",2020,Both groups had very high patient satisfaction scores; there was no statistical difference between them.  ,[],['additional counseling that encouraged a discussion or a standard informed consent for cesarean birth'],"['birth satisfaction', 'Unplanned Cesarean Birth']",[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",,0.0198502,Both groups had very high patient satisfaction scores; there was no statistical difference between them.  ,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burcher', 'Affiliation': 'Department of Obstetrics and Gynecology, WellSpan York Hospital, York, Pennsylvania, USA.'}, {'ForeName': 'Shazneen', 'Initials': 'S', 'LastName': 'Hushmendy', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Chan-Mahon', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Dasani', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Jazmine', 'Initials': 'J', 'LastName': 'Gabriel', 'Affiliation': 'Penn State Health, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}]",AJOB empirical bioethics,['10.1080/23294515.2020.1817174']
2752,32941801,Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly.,"BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).",2020,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","['elderly patients (n\xa0= 198) received', 'Elderly']","['BCG', 'BCG vaccination', 'Activate', 'BCG or placebo vaccine']","['frequency of adverse effects', 'incidence of new infections', 'time to first infection']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.444856,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","[{'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece. Electronic address: egiamarel@med.uoa.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsilika', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Moorlag', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Antonakos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antigone', 'Initials': 'A', 'LastName': 'Kotsaki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Domínguez-Andrés', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Maria-Evangelia', 'Initials': 'ME', 'LastName': 'Adami', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Damoraki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Koufargyris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Karageorgos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Bolanou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Koenen', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Dionyssia-Irene', 'Initials': 'DI', 'LastName': 'Droggiti', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Renieris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Papadopoulos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.'}]",Cell,['10.1016/j.cell.2020.08.051']
2753,32946700,"Gender, having a positive FIT and type of hospital are important factors for colonoscopy experience in colorectal cancer screening - findings from the SCREESCO study.","OBJECTIVES


Assessing the experience of screening procedures is crucial for improving the quality and acceptance of colonoscopy in colorectal cancer screening. The aim of the study was to investigate the colonoscopy experience and associated factors among individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study.
METHODS


Participants in the Screening of Swedish Colons (SCREESCO;  n  = 7593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled. The primary outcome was overall colonoscopy experience measured with a study-specific questionnaire. Secondary endpoints were measured using multiple regression analyses with factors that included sex, randomization group, geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer.
RESULTS


A total of 6572 (87%) individuals responded to the questionnaire. The majority was satisfied with the information, care and treatment. Women reported more worry, discomfort and pain, but also better information, care and treatment compared with men. The FIT group was more worried and perceived more discomfort and pain than the colonoscopy group. Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
CONCLUSIONS


Although most participants were satisfied with the colonoscopy experience, the study has highlighted areas for improvement. Important factors for colonoscopy experience were gender, randomization group, and type of hospital and therefore crucial to bear in mind when designing screening programs.",2020,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","['A total of 6572 (87%) individuals responded to the questionnaire', 'Type of hospital (geographical region; university hospital vs. not university hospital', 'Participants in the Screening of Swedish Colons (SCREESCO;  n \u2009=\u20097593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled', 'individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study']",[],"['overall colonoscopy experience measured with a study-specific questionnaire', 'discomfort and pain', 'geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer', 'worry, discomfort and pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",7593.0,0.0690388,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","[{'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Fritzell', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wangmar', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Division of Biostatics, Institution of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hultcrantz', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1820568']
2754,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
2755,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
2756,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
2757,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
2758,32950693,Analysis of Time to Complete Response after Defibrotide Initiation in Patients with Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation.,"Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially life-threatening complication that occurs after hematopoietic cell transplantation (HCT). The mortality associated with untreated VOD/SOS with multiorgan dysfunction (MOD) has been reported to be >80%. The recommended dose of defibrotide is 6.25 mg/kg every 6 hours, administered as a 2-hour i.v. infusion, for a minimum of 21 days or until resolution of VOD/SOS signs and symptoms. The objective of this analysis was to evaluate the time to complete response (CR) in patients with post-HCT VOD/SOS treated with defibrotide. The time to defibrotide discontinuation due to a CR served as a surrogate for time to CR in an expanded access study (T-IND; ClinicalTrials.gov NCT00628498; n = 1000), and was analyzed separately from the time to CR data pooled from a phase 2 randomized dose-finding study (NCT00003966; n = 74 patients who received 25 mg/kg/day) and a phase 3 historically controlled study (NCT00358501; n = 102). For all studies, a CR was defined as total serum bilirubin <2 mg/dL with resolution of VOD/SOS-related MOD (renal and/or pulmonary dysfunction); the phase 2 study also required resolution of central nervous system dysfunction. In the T-IND, 390 patients discontinued treatment due to a CR and had sufficient data for analysis. The median time to discontinuation was 22 days (range, 2 to 64 days). Discontinuation due to CR occurred beyond 21 days in 235 patients (60%) and beyond 28 days in 57 patients (15%). The pooled phase 2 and 3 studies included 60 patients who achieved a CR, with a median time to CR of 24.5 days (range, 7 to 123 days). A CR was achieved beyond 21 days in 32 patients (53%) and beyond 28 days in 24 patients (40%). The Kaplan-Meier estimate of day +100 survival rate was substantially higher in patients who discontinued due to a CR compared with those who did not (92.5% versus 37.3%). Treatment-emergent adverse events occurred in 185 of 390 patients (47%) who discontinued due to a CR in the T-IND and in 55 of 60 patients (92%) who achieved a CR in the pooled phase 2 and 3 studies, and rates did not differ according to duration of treatment (≤21 days versus >21 days). Taken together, these results highlight the importance of continued defibrotide therapy until resolution of VOD/SOS signs and symptoms, as currently indicated in the approved product labels, which may occur beyond the recommended minimum of 21 days.",2020,The Kaplan-Meier-estimated Day 100 survival rate was substantially higher in patients who discontinued due to a CR than those who did not (92.5% vs 37.3%).,"['Patients with Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation', 'Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS', 'patients with VOD/SOS post-HCT treated with']",['defibrotide'],"['Mortality', 'total serum bilirubin', 'median time to discontinuation', 'median time to CR', 'Treatment-emergent adverse events', 'time to complete response (CR', 'Kaplan-Meier-estimated Day 100 survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019156', 'cui_str': 'Veno-occlusive disease of the liver'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0057257', 'cui_str': 'defibrotide'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0539795,The Kaplan-Meier-estimated Day 100 survival rate was substantially higher in patients who discontinued due to a CR than those who did not (92.5% vs 37.3%).,"[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Department of Medical Oncology, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts. Electronic address: Paul_Richardson@dfci.harvard.edu.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Kernan', 'Affiliation': 'Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Lehmann', 'Affiliation': 'Department of Pediatric Hematology/Oncology, Center for Stem Cell Transplantation, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ryan', 'Affiliation': 'Jazz Pharmaceuticals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.09.008']
2759,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE


To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS


Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS


Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS


The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2760,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND


The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM


To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS


In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION


The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2761,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
2762,32957482,"Oxygen: The Rate-Limiting Factor for Episodic Memory Performance, Even in Healthy Young Individuals.","Cognition is a crucial element of human functionality. Like any other physical capability, cognition is both enabled and limited by tissue biology. The aim of this study was to investigate whether oxygen is a rate-limiting factor for any of the main cognitive domains in healthy young individuals. Fifty-six subjects were randomly assigned to either increased oxygen supply using hyperbaric oxygen (two atmospheres of 100% oxygen) or to a ""sham"" treatment (a simulation of increased pressure in a chamber with normal air). While in the chamber, participants went through a battery of tests evaluating the major cognitive domains including information processing speed, episodic memory, working memory, cognitive flexibility, and attention. The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group. The hyper-oxygenized group demonstrated a better learning curve and a higher resilience to interference. To conclude, oxygen delivery is a rate-limiting factor for memory function even in healthy young individuals under normal conditions. Understanding the biological limitations of our cognitive functions is important for future development of interventional tools that can be used in daily clinical practice.",2020,"The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group.","['Healthy Young Individuals', 'healthy young individuals', 'healthy young individuals under normal conditions', 'Fifty-six subjects']","['increased oxygen supply using hyperbaric oxygen (two atmospheres of 100% oxygen) or to a ""sham"" treatment (a simulation of increased pressure in a chamber with normal air', 'Oxygen']","['episodic memory', 'major cognitive domains including information processing speed, episodic memory, working memory, cognitive flexibility, and attention']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231162', 'cui_str': 'Normal general body function'}]","[{'cui': 'C0311412', 'cui_str': 'Increased oxygen supply'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677038', 'cui_str': 'Increase in pressure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",56.0,0.0265434,"The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group.","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Suzin', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Halpert Frolinger', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Yogev', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Catalogna', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rassovsky', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat-Gan 5290002, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Efrati', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}]",Biomolecules,['10.3390/biom10091328']
2763,32958483,Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.,"INTRODUCTION


Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.
METHODS AND ANALYSIS


The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle.
ETHICS AND DISSEMINATION


The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language.
TRIAL REGISTRATION NUMBER


NCT03988985.",2020,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"['1074 primary care patients from North, East and South Germany', 'cardiac patients']","['Depression screening using patient-targeted feedback', 'patient-targeted feedback intervention', 'receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback']","['patient engagement in mental healthcare, professional depression care and cost-effectiveness', 'depression severity (PHQ-9']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",1074.0,0.195457,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany s.kohlmann@uke.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Eisele', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lea-Elena', 'Initials': 'LE', 'LastName': 'Braunschneider', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Department of Primary Care, University Medical Centre Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Resmark', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonius', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Department of Primary Care, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allwang', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nikendei', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy for General Internal Medicine and Psychosomatics, University Medical Centre of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Department of Primary Care, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Department of Psychosocial Medicine and Psychotherapy, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035973']
2764,32958487,Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study.,"INTRODUCTION


Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals. Helping people discuss and formalise their preferences in end-of-life care, as planned in the Go Wish intervention, could reduce health-related anxiety in the advance care planning (ACP) and advance directive (AD) process. The aims of this study are (1) to test the effectiveness of the Go Wish intervention among outpatients in early-stage palliative care and (2) to understand the role of defence mechanisms in end-of-life discussions among nurses, patients and relatives.
METHODS AND ANALYSIS


A mixed-methods study will be performed. A cluster randomised controlled trials with three parallel arms will be conducted with 45 patients with chronic progressive diseases impacting life expectancy in each group: (1) Group A, Go Wish intervention for patients and their relatives; (2) Group A, Go Wish intervention for patients alone and (3) Group B, for patients (with a waiting list), who will receive the standardised information on ADs (usual care). Randomisation will be at the nurse level as each patient is referred to one of the 20 participating nurses (convenience sample of 20 nurses). A qualitative study will be conducted to understand the cognitive and emotional processes and experiences of nurses, patients and relatives confronted with end-of-life discussions. The outcome measurements include the completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Human Research Ethics Committee of the Canton of Geneva, Switzerland (no. 2019-00922). The findings will be disseminated to practice (nurses, patients and relatives), to national and international scientific conferences, and peer-reviewed journals covering nursing science, psychology and medicine.
TRIAL REGISTRATION NUMBER


NCT04065685.",2020,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","['outpatients in early-stage palliative care', '45 patients with chronic progressive diseases impacting life expectancy in each group', '20 participating nurses (convenience sample of 20 nurses', 'outpatients in early-stage palliative care and (2']",['Nurse-led patient-centred intervention to increase written advance directives'],"['completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",45.0,0.102533,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Iglesias', 'Affiliation': 'School of Health Sciences (HEdS-FR), HES-SO University of Applied Sciences and Arts Western Switzerland, Friourg, Switzerland katia.iglesias@hefr.ch.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Busnel', 'Affiliation': 'Geneva Institution for Homecare and Assistance (imad), Geneva, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Dufour', 'Affiliation': 'School of Management and Engineering Vaud (HEIG-VD), HES-SO University of Applied Sciences and Arts Western Switzerland, Yverdon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Division of Palliative Medicine, Department of rehabilitation and geriatrics, University Hospitals Geneva, Geneva, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Séchaud', 'Affiliation': 'Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-037144']
2765,32965395,"Rationale and design of the ""Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled"" trial (TOCIBRAS).","INTRODUCTION


Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
METHODS AND ANALYSIS


This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
ETHICS AND DISSEMINATION


The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.",2020,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","['patients with moderate to severe COVID-19', 'patients with COVID-19', 'Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment']","['tocilizumab', 'tocilizumab plus standard of care versus standard of care alone', 'Tocilizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.229721,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","[{'ForeName': 'Danielle Leão Cordeiro de', 'Initials': 'DLC', 'LastName': 'Farias', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Prats', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, Estados Unidos.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Centro Internacional de Pesquisa, Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Salomón Soriano Ordinola', 'Initials': 'SSO', 'LastName': 'Rojas', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Cleyton Zanardo de', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Luis Eduardo Coelho', 'Initials': 'LEC', 'LastName': 'Andrade', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Alex Freire', 'Initials': 'AF', 'LastName': 'Sandes', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Carolina', 'Initials': 'MC', 'LastName': 'Pintão', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudio Galvão de', 'Initials': 'CG', 'LastName': 'Castro Júnior', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Scheinberg', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200060']
2766,32965539,"A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.","PURPOSE


The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).
METHODS


This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo: days 2-3); and 3-day ART (ART-123: days 1-3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.
RESULTS


Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI -.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.
CONCLUSION


ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016.",2020,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","['Seventy-nine participants (placebo n\u2009=\u200928, 1-day ART n\u2009=\u200927, 3-day ART n\u2009=\u200924) received study drugs', 'III colon cancer patients who received']","['ART-123', 'placebo', 'recombinant thrombomodulin (ART-123', 'adjuvant mFOLFOX6 chemotherapy', 'placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo']","['OIPN', 'severe bleeding adverse events', 'Neurotoxicity-12 (FACT/GOG-Ntx-12) score', 'cumulative incidence of NCI-CTCAE grade\u2009≥\u20092 sensory neuropathy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",,0.727589,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04135-8']
2767,32960886,Effects of telephone-based health coaching on patient-reported outcomes and health behavior change: A randomized controlled trial.,"OBJECTIVE


Telephone based health coaching (TBHC) seems to be a promising approach to foster self-management in patients with chronic conditions. The aim of this study was to evaluate the effectiveness of a TBHC on patient-reported outcomes and health behavior for people living with chronic conditions in Germany.
METHODS


Patients insured at a statutory health insurance were randomized to an intervention group (IG; TBHC) and a control group (CG; usual care), using a stratified random allocation before giving informed consent (Zelen's single-consent design). The TBHC was based on motivational interviewing, goal setting, and shared decision-making and carried out by trained nurses. All outcomes were assessed yearly for three years. We used mixed effects models utilizing all available data in a modified intention-to-treat sample for the main analysis. Participants and study centers were included as random effects. All models were adjusted for age, education and campaign affiliation.
RESULTS


Of the 10,815 invited patients, 4,283 returned their questionnaires at baseline. The mean age was 67.23 years (SD = 9.3); 55.5% were female. According to the model, TBHC was statistically significant superior to CG regarding 6 of 19 outcomes: physical activity in hours per week (p = .030) and in metabolic rate per week (p = .048), BMI (p = .009) (although mainly at baseline), measuring blood pressure (p< .001), patient activation (p< .001), and health literacy (p< .001). Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive. Within-group contrasts indicating changes from baseline to follow-ups and significant between-group comparisons regarding these changes supported the findings. Standardized effect sizes were small. TBHC did not show any effect on mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress. Campaign-specific subgroup effects were detected for 'foot monitoring by a physician' and 'blood sugar measurement'.
CONCLUSION


TBHC interventions might have small effects on some patient reported and behavioral outcomes.
PRACTICE IMPLICATIONS


Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions.
REGISTRATION


German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS): DRKS00000584.",2020,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","['people living with chronic conditions in Germany', '10,815 invited patients', 'The mean age was 67.23 years (SD = 9.3); 55.5% were female', 'Patients insured at a statutory health insurance', 'patients with chronic conditions']","['TBHC', 'Telephone based health coaching (TBHC', 'control group (CG; usual care', 'intervention group (IG; TBHC', 'telephone-based health coaching']","['BMI', 'mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress', 'metabolic rate', 'blood pressure', 'physical activity', 'health behavior change', 'health literacy', 'patient activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",10815.0,0.0789462,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwinger', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Statutory Health Insurance, Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",PloS one,['10.1371/journal.pone.0236861']
2768,32960889,Bifidobacterium animalis subsp lactis HN019 presents antimicrobial potential against periodontopathogens and modulates the immunological response of oral mucosa in periodontitis patients.,"OBJECTIVE


To evaluate the effects of Bifidobacterium animalis subsp. lactis HN019 (HN019) on clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels) in non-surgical periodontal therapy in generalized chronic periodontitis (GCP) patients. Adhesion to buccal epithelial cells (BEC) and the antimicrobial properties of HN019 were also investigated.
MATERIALS AND METHODS


Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days. Patients were randomly assigned to Test (SRP+Probiotic, n = 15) or Control (SRP+Placebo, n = 15) group. Probiotic lozenges were used for 30 days. Gingival tissues and saliva were immunologically analyzed. The adhesion of HN019 with or without Porphyromonas gingivalis in BEC and its antimicrobial properties were investigated in in vitro assays. Data were statistically analyzed (p<0.05).
RESULTS


Test group presented lower plaque index (30 days) and lower marginal gingival bleeding (90 days) when compared with Control group. Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group. HN019 reduced the adhesion of P. gingivalis to BEC and showed antimicrobial potential against periodontopathogens.
CONCLUSION


Immunological and antimicrobial properties of B. lactis HN019 make it a potential probiotic to be used in non-surgical periodontal therapy of patients with GCP.
CLINICAL RELEVANCE


B. lactis HN019 may be a potential probiotic to improve the effects of non-surgical periodontal therapy. Name of the registry and registration number (ClinicalTrials.gov): ""Effects of probiotic therapy in the treatment of periodontitis""-NCT03408548.",2020,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","['generalized chronic periodontitis (GCP) patients', 'periodontitis patients', 'patients with GCP', 'Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days']","['Bifidobacterium animalis subsp', 'probiotic therapy', 'Control (SRP+Placebo', 'Probiotic lozenges']","['marginal gingival bleeding', 'Higher BD-3, TLR4 and CD-4 expressions', 'clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels', 'lower plaque index', 'adhesion of P. gingivalis to BEC', 'Gingival tissues and saliva']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0887942', 'cui_str': 'beta-Defensins'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0020987', 'cui_str': 'Immunologic competence'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}]",30.0,0.0273598,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","[{'ForeName': 'Marcos M', 'Initials': 'MM', 'LastName': 'Invernici', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Flávia A C', 'Initials': 'FAC', 'LastName': 'Furlaneto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Sérgio L', 'Initials': 'SL', 'LastName': 'Salvador', 'Affiliation': 'Department of Clinical Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'Dupont, Nutrition and Health, Kantvik, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Salminen', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mantziari', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Vinderola', 'Affiliation': 'Instituto de Lactología Industrial (UNL-CONICET), National University of the Litoral, Santa Fe, Argentina.'}, {'ForeName': 'Edilson', 'Initials': 'E', 'LastName': 'Ervolino', 'Affiliation': 'Division of Histology, Department of Basic Sciences, Dental School of Araçatuba, São Paulo State University, São Paulo, Brazil.'}, {'ForeName': 'Sandro Isaías', 'Initials': 'SI', 'LastName': 'Santana', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Felix', 'Initials': 'PHF', 'LastName': 'Silva', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Michel R', 'Initials': 'MR', 'LastName': 'Messora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0238425']
2769,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS


Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS


This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS


The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION


Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
2770,32961681,The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy.,"The purpose of this study was to assess the influence of hippotherapy (therapy with horses) on posture and body function among children with cerebral palsy. A case-control study included forty-five children aged 6-12 years, classified as Gross Motor Function Classification System (GMFCS) level I or II, with spastic diplegia or hemiplegia. The participants were randomly divided into three groups: study I (n = 15), study II (n = 15) and control (n = 15). The children from the study groups attended 30min hippotherapy sessions for 12 consecutive weeks, twice (study group I) or once (study group II) a week. The Sitting Assessment Scale (SAS) was used. A comparison of SAS showed an improvement in almost all the assessed categories among the children who participated in hippotherapy. In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028). Hippotherapy has a positive influence on the body posture and function of individual body parts in a sitting position among children with cerebral palsy.",2020,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","['children who participated in hippotherapy', 'forty-five children aged 6-12 years, classified as Gross Motor Function Classification System ', 'children with cerebral palsy', 'Children with Cerebral Palsy']","['Hippotherapy', 'hippotherapy (therapy with horses', 'SAS']","['trunk control', 'Sitting Assessment Scale (SAS', 'posture and body function', 'head position control, arm function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",45.0,0.0101334,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","[{'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Matusiak-Wieczorek', 'Affiliation': 'Sports Medicine Institute, Social and Preventive Medicine Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Dziankowska-Zaborszczyk', 'Affiliation': 'Epidemiology and Biostatistics Institute, Social and Preventive Medicine Department, Medical University of Lodz, 90-752 Lodz, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Synder', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Borowski', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186846']
2771,32961793,Conventional and Virtual Reality Mirror Therapies in Upper Obstetric Brachial Palsy: A Randomized Pilot Study.,"The abilities of children diagnosed with Obstetric Brachial Palsy (OBP) are limited by brachial plexus injuries. Thus, their participation in the community is hindered, which involves a lower quality of life due to worse performance in activities of daily living as a consequence of the functional limitations of the affected upper limb. Conventional Mirror Therapy (Conventional MT) and Virtual Therapy improve the affected upper limb functionality. Therefore, the aim of this study was to compare the effects of Conventional MT and Virtual Reality MT on the spontaneous use of the affected upper limb and quality of life of children with upper Obstetric Brachial Palsy between 6 and 12 years of age. A randomized pilot study was performed. Twelve children were randomly assigned to perform Conventional Mirror Therapy or Virtual Reality Mirror Therapy for four weeks. Ten children completed the treatment. Two assessments (pre/post-intervention) were carried out to assess the spontaneous use of the affected upper limb and the quality of life using the Children's Hand-use Experience Questionnaire (CHEQ) and the Pediatric Quality of Life Inventory Generic Core Scales (PedsQL TM 4.0), respectively. There was a statistically significant increment in spontaneous use, observed in independent tasks ( p  = 0.02) and in the use of the affected hand with grasp ( p  = 0.04), measured with the CHEQ, for the Virtual Reality MT group. There were no statistically significant changes ( p  > 0.05) for the Conventional MT group in the spontaneous use of the affected upper limb. Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0. Statistically significant changes were not obtained for the quality of life in the Conventional MT group. This study suggests that, compared to Conventional MT, Virtual Reality MT would be a home-based therapeutic complement to increase independent bimanual tasks using grasp in the affected upper limb and improve the quality of life of children diagnosed with upper OBP in the age range of 6-12 years.",2020,"Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0.","['children diagnosed with Obstetric Brachial Palsy (OBP', 'Upper Obstetric Brachial Palsy', 'children diagnosed with upper OBP in the age range of 6-12 years', 'children with upper Obstetric Brachial Palsy between 6 and 12 years of age', 'Twelve children']","['Conventional MT and Virtual Reality MT', 'Conventional and Virtual Reality Mirror Therapies', 'Conventional Mirror Therapy (Conventional MT) and Virtual Therapy', 'Conventional Mirror Therapy or Virtual Reality Mirror Therapy']","['Physical and Health activity categories', ""quality of life using the Children's Hand-use Experience Questionnaire (CHEQ) and the Pediatric Quality of Life Inventory Generic Core Scales"", 'quality of life', 'spontaneous use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",12.0,0.0449876,"Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Yeves-Lite', 'Affiliation': 'San-José Institute Foundation, Avda. de la Hospitalidad, s/n, 28054 Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Zuil-Escobar', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, Urb. Montepríncipe, s/n., 28668 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Cepa', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, Urb. Montepríncipe, s/n., 28668 Madrid, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ferri-Morales', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9093021']
2772,32961806,Feasibility of Ultra-Low-Dose CT for Bronchoscopy of Peripheral Lung Lesions.,"Background and objectives : Thin-section computed tomography (CT) is essential for identifying small bronchi during bronchoscopy using radial endobronchial ultrasound. Some patients should receive an additional CT for a thin-section image. We performed a retrospective study with a prospectively collected database to identify the optimal radiation dose for thin-section CT during peripheral bronchoscopy.  Materials and Methods : In total, 91 patients with peripheral lung lesions underwent thin-section CT (both standard CT as a reference and ultra-low-dose CT (ultra-LDCT)). The patients were randomly assigned to one of four groups according to the ultra-LDCT parameters: group 1 = 120 kVp, 25 mAs; group 2 = 100 kVp, 15 mAs; group 3 = 120 kVp, 5 mAs; and group 4 = 100 kVp, 5 mAs. Two radiologists and two physicians analyzed both the standard CT and ultra-LDCT.  Results : The effective doses (EDs) of ultra-LDCT significantly differed among the four groups (median EDs were 0.88, 0.34, 0.19, and 0.12 mSv for groups 1-4, respectively;  p  < 0.001). Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively). Bronchus signs on ultra-LDCT in groups 1 and 2 were well correlated with those of the standard-dose CT (accuracies of two radiologists and two pulmonary physicians were 95-100%).  Conclusions : Our results indicate that ultra-LDCT with ED of >0.34 mSv (ED of group 2) is feasible for peripheral bronchoscopy.",2020,"Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively).","['91 patients with peripheral lung lesions underwent', 'Bronchoscopy of Peripheral Lung Lesions']","['ultra-LDCT', 'thin-section CT', 'Ultra-Low-Dose CT', 'Thin-section computed tomography (CT', 'Materials and Methods ']","['peripheral airway wall thickness', 'median wall thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0026040', 'cui_str': 'Thin Sectioning'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",91.0,0.0308828,"Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively).","[{'ForeName': 'Jung Seop', 'Initials': 'JS', 'LastName': 'Eom', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Geewon', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan 43241, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Roh', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Hyun Sung', 'Initials': 'HS', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Jeong', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan 43241, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56090479']
2773,32961834,Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial.,"Background:  Brief counseling and self-monitoring with a pedometer are common practice within primary care for physical activity promotion. It is unknown how high-tech electronic activity monitors compare to pedometers within this setting. This study aimed to investigate the outcomes, through effect size estimation, of an electronic activity monitor-based intervention to increase physical activity and decrease cardiovascular disease risk.  Method:  The pilot randomized controlled trial was pre-registered online at clinicaltrials.gov (NCT02554435). Forty overweight, sedentary participants 55-74 years of age were randomized to wear a pedometer or an electronic activity monitor for 12 weeks. Physical activity was measured objectively for 7 days at baseline and follow-up by a SenseWear monitor and cardiovascular disease risk was estimated by the Framingham risk calculator.  Results:  Effect sizes for behavioral and health outcomes ranged from small to medium. While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  Conclusion:  The results of this pilot trial show promise for this low-intensity intervention strategy, but large-scale trials are needed to test its efficacy.",2020,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","['Forty overweight, sedentary participants 55-74 years of age']","['electronic activity monitor-based intervention', 'Electronic Activity Monitors and Pedometers', 'electronic activity monitor']","['physical activity (PA', 'Physical activity', 'general health', 'Health']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0880024,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","[{'ForeName': 'Zakkoyya H', 'Initials': 'ZH', 'LastName': 'Lewis', 'Affiliation': 'College of Science, Department of Kinesiology and Health Promotion, California State Polytechnic University Pomona, 3801 West Temple Ave., Pomona, CA 91768, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ottenbacher', 'Affiliation': 'School of Health Professions, Division of Rehabilitation Sciences, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Steve R', 'Initials': 'SR', 'LastName': 'Fisher', 'Affiliation': 'School of Health Professions, Department of Physical Therapy, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, 1400 Pressler St., Unit 1411, Houston, TX 77030-4008, USA.'}, {'ForeName': 'Arleen F', 'Initials': 'AF', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of General Internal Medicine and Health Services Research, University of California Los Angeles, 1100 Glendon, Ave., Los Angeles, CA 90095, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Swartz', 'Affiliation': 'Department of Pediatrics, Division of Pediatrics, MD Anderson Cancer Center, 7777 Knight Rd., Houston, TX 77054, USA.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Lyons', 'Affiliation': 'School of Health Professions, Department of Nutrition and Metabolism, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186800']
2774,32961848,Body Image Relates to Exercise-Induced Antinociception and Mood Changes in Young Adults: A Randomized Longitudinal Exercise Intervention.,"Background:  An important motivation for adolescents and young adults to engage in aerobic exercise (AE) is to improve fitness, body composition and physical appearance. These parameters have an impact on bodily perception as conceptualized by the 'body image' (BI) construct. AE is known to have positive effects on pain perception, mood, and body image (BI). However, no study has hitherto investigated their interrelationship within one study.  Methods:  Participants were randomly assigned to an intervention group (IG,  n  = 16, 6 months of AE) or a passive control group (CG,  n  = 10). Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data from baseline (T0) and the end of the intervention (T6) were analyzed using a paired  t -test ( p  < 0.05).  Results:  A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  Conclusion:  Data in young adults undergoing AE indicate that changes in the BI sub-category 'physical efficacy' are closely linked with changes in positive affect and antinociception. These novel findings suggest that BI plays a role in antinociception and positive affect.",2020,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","['Young Adults', 'adolescents and young adults', 'young adults undergoing AE']","['aerobic exercise (AE', 'intervention group (IG,  n  = 16, 6 months of AE) or a passive control']","['Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data', ""BI dimension 'physical efficacy"", 'pain perception, mood, and body image (BI']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",,0.0351208,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Maurer', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Deckert', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Levenig', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schörkmaier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Stangier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Attenberger', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hasenbring', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17186801']
2775,32961875,Tele-Assisted Behavioral Intervention for Families with Children with Autism Spectrum Disorders: A Randomized Control Trial.,"BACKGROUND


Telehealth is useful for both autism spectrum disorder (ASD) diagnosis and treatment, but studies with a direct comparison between teletherapy and traditional in-person therapy are limited.
METHODS


This randomized control trial-ISRCTN (International Standard Randomised Controlled Trial Number) primary clinical trial registry ID ISRCTN15312724-was aimed at comparing the effect of a tele-assisted and in-person intervention based on a behavioral intervention protocol for families with children affected by ASDs. Forty-two parents with children with autism (30 months to 10 years old) were randomly assigned to 12 sessions of an applied behavioral analysis (ABA) intervention implemented in an individual and group setting, either with or without the inclusion of tele-assistance. Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
RESULTS


Substantial improvements in the perception and management of children's behavior by parents, as well as in the influence of a reduction in parent stress levels on said children's behavior through the use of a tele-assisted intervention, were obtained.
CONCLUSIONS


This randomized controlled trial demonstrates the evidence-based potential for telehealth to improve treatment of ASDs.",2020,"Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
","['Families with Children with Autism', 'families with children affected by ASDs', 'Spectrum Disorders', 'Forty-two parents with children with autism (30 months to 10 years old']","['behavioral intervention protocol', 'Tele-Assisted Behavioral Intervention', 'tele-assisted and in-person intervention', 'applied behavioral analysis (ABA) intervention implemented in an individual and group setting, either with or without the inclusion of tele-assistance']",['Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}]",42.0,0.120457,"Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
","[{'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Marino', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Chilà', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Failla', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Crimi', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Minutoli', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Alfio', 'Initials': 'A', 'LastName': 'Puglisi', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Antonino Andrea', 'Initials': 'AA', 'LastName': 'Arnao', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Tartarisco', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Ruta', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vagni', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pioggia', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}]",Brain sciences,['10.3390/brainsci10090649']
2776,32961878,Poor Sleep Quality Decreases Concurrent Training Benefits in Markers of Metabolic Syndrome and Quality of Life of Morbidly Obese Patients.,"Background:  Sleep quality (SQ) plays a role in multiple activities of daily living, but little is known about its role in concurrent training [CT, high-intensity interval (HIIT) plus resistance training (RT)] adaptations for metabolic syndrome (MetS) and health-related quality of life (HRQoL) markers. The aim of the present study was to determine the effects of a 20-week CT programme on MetS and HRQoL markers according to the SQ of morbidly obese patients.  Methods:  Twenty-nine morbidly obese patients were allocated to one of two groups: good sleep quality (GSQ, n = 15, 38.07 ± 12.26 years) and poor sleep quality (PSQ, n = 14, 40.79 ± 11.62 years). HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes were measured.  Results:  The GSQ group reported significant changes (pre- vs. post-intervention) in WC (114.0 ± 3.1 vs. 110.4 ± 3.4 cm, p = 0.012), systolic blood pressure (SBP) (137.0 ± 4.3 vs. 125.6 ± 1.8 mmHg, p = 0.006), and HRQoL general health (51.33 ± 21.08 vs. 64.33 ± 16.24, p = 0.020). By contrast, the PSQ group showed significant changes only in SQ (9.00 ± 2.42 vs. 5.36 ± 2.84, p = 0.004).  Conclusions:  Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers. However, there was a greater effect size for decreasing WC and SBP in favour of the GSQ compared with the PSQ group, suggesting that there are limitations to CT benefits on these outcomes in the PSQ group. These results call for more complex future studies.",2020,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"['Morbidly obese PSQ patients', 'morbidly obese patients', 'Morbidly Obese Patients', 'Twenty-nine morbidly obese patients']","['PSQ', 'GSQ', '20-week CT programme']","['MetS and HRQoL markers', 'systolic blood pressure (SBP', 'good sleep quality', 'HRQoL general health', 'HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes', 'poor sleep quality']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",29.0,0.0506513,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delgado-Floody', 'Affiliation': 'Department of Physical Education, Sport and Recreation, Universidad de La Frontera, Temuco 4780000, Chile.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'Department of Didactics of Corporal Expression, University of Jaen, 23400 Jaen, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerez-Mayorga', 'Affiliation': 'Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago 7591538, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Caamaño-Navarrete', 'Affiliation': 'Faculty of Education, Universidad Católica de Temuco, Temuco 4780000, Chile.'}, {'ForeName': 'Johnattan', 'Initials': 'J', 'LastName': 'Cano-Montoya', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, Universidad San Sebastian, Valdivia 5090000, Chile.'}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'Laredo-Aguilera', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Carmona-Torres', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Cobo-Cuenca', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Pozuelo-Carrascosa', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Álvarez', 'Affiliation': 'Quality of Life and Wellness Research Group API4, Laboratory of Human Performance, Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno 5290000, Chile.'}]",International journal of environmental research and public health,['10.3390/ijerph17186804']
2777,32962055,"Breastfeeding at 1, 3 and 6 Months after Birth According to the Mode of Birth: A Correlation Study.","BACKGROUND


Breastfeeding is a determinant of child and maternal health. However, evidence is limited on how mode of birth influences breastfeeding. Research aim: To examine the mode of birth and breastfeeding duration and the type of lactation at one, three and six months after birth in XXX, during 2017.
METHODS


Correlation study on breastfeeding duration and type of lactation during the six months after birth, and mode of birth, in a randomised sample. Women ≥18 years of age with term singleton infants, were included. Collected data through interviews and hospital records. Pearson's and Spearman's correlation analyses were conducted. SPSSv21 and α = 0.05 were used.
RESULTS


Breastfeeding duration was shorter in women with greater parity (-0.055 **) ( p  < 0.01) and epidural analgesia (0.057 **) ( p  < 0.01), and longer in mothers with episiotomy (-0.267 **) ( p  < 0.01). Episiotomy was associated with breastfeeding at one month (0.112 **) ( p  < 0.01), and at six months (0.347 *) ( p  < 0.01). The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140 **) ( p  < 0.01) and higher at six months (0.013 **) ( p  < 0.01). The percentages of breastfeeding at three months were significantly greater in women with no perineal tears (2.1) ( p  < 0.05). At six months, small rates of breastfeeding were found in women with greater parity (0.051 **) ( p  < 0.01). No significant association was detected, neither between the type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth.
CONCLUSIONS


Epidural analgesia, episiotomy, perineal tears and parity influence the type of lactation and duration of breastfeeding during the six months after birth. The results suggest no association between the type of lactation and the mode of birth or between breastfeeding duration and the mode of birth.",2020,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"['women with greater parity ', 'Women ≥18 years of age with term singleton infants']",['epidural analgesia'],"['small rates of breastfeeding', 'Episiotomy', 'percentages of breastfeeding', 'type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth', 'epidural analgesia', 'prevalence of breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0335807,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Agea-Cano', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Linares-Abad', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio Gregorio', 'Initials': 'AG', 'LastName': 'Ceballos-Fuentes', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Calero-García', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186828']
2778,32962057,Effects of Simulation Practicum Using Flipped Learning for Korean Nursing Students.,"This study aimed to examine the effects of simulation practicum using flipped learning on nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction of Korean nursing students. This study used a quasi-experimental pretest-posttest control group design. The samples used were from 101 nursing students (Intervention 1:  n  = 34; Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea. For the experimental interventions, participants in the intervention group 1 were applied by simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum. Participants in the control group were applied by lecture-based practicum using a model. The measures were the study participants' general characteristics survey, the nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale. There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups. It was seen in this study that simulation practicum using flipped learning was the most effective teaching and learning method for the nursing practicum of Korean nursing students. The simulation practicum using flipped learning can be useful in providing nursing practicum to nursing students.",2020,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","['101 nursing students (Intervention 1:  n  = 34', 'Korean Nursing Students', 'Korean nursing students']","['Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea', 'Simulation Practicum Using Flipped Learning', 'simulation practicum using flipped learning', 'simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum']","['nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",101.0,0.0135524,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","[{'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Nursing, College of Science and Technology, Daejin University, Pocheon-si, Gyeonggi-do 11159, Korea.'}, {'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul 02447, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186829']
2779,32962176,Predictors of Changes in Alcohol Craving Levels during a Virtual Reality Cue Exposure Treatment among Patients with Alcohol Use Disorder.,"BACKGROUND/OBJECTIVE


Determining the predictive variables associated with levels of alcohol craving can ease the identification of patients who can benefit from treatments. This study aimed to describe changes (improvement or no change/deterioration) in alcohol craving levels and explore the predictors of these changes from admission to discharge in outpatients with alcohol use disorder (AUD) undergoing treatment-as-usual (TAU), or treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET).
METHOD


A prospective cohort study was conducted amongst 42 outpatients with AUD (n = 15 TAU + VR-CET and n = 27 TAU) from a clinical setting. Changes in the levels of alcohol craving between admission and discharge were assessed with the Multidimensional Alcohol Craving Scale. Sociodemographic characteristics (age, gender, education, and socioeconomic and civil status), cognitive-affective behavioral patterns (AUD severity, abstinence duration, psychiatric comorbidity, state anxiety, attentional bias, and substance use), and type of treatment (TAU + VR-CET and only TAU) were also evaluated.
RESULTS


The TAU + VR-CET group showed greater changes of improvement in the levels of alcohol craving than the TAU group (χ 2  = 10.996;  p  = 0.001). Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503). The odds of an improvement in any of the craving levels between pre- and post-test was 18.18 (1/0.055) times higher in the TAU + VR-CET group with respect to the TAU group. The use of illicit drugs in the month prior to the test increased the odds of having a positive change by 18.18 (1/0.055) with respect to not having consumed.
CONCLUSIONS


Including VR-CET in TAU programs may provide benefits in the treatment of AUDs mainly among patients with intense alcohol craving and individuals having used illicit substances prior to treatment.",2020,Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503).,"['Patients with Alcohol Use Disorder', '42 outpatients with AUD (n = 15 TAU + VR-CET and n = 27 TAU) from a clinical setting', 'outpatients with alcohol use disorder (AUD) undergoing treatment-as-usual (TAU), or treatment-as-usual supplemented with', 'patients with intense alcohol craving and individuals having used illicit substances prior to treatment']","['virtual reality cue-exposure therapy (TAU + VR-CET', 'Virtual Reality Cue Exposure Treatment']","['Multidimensional Alcohol Craving Scale', 'Sociodemographic characteristics (age, gender, education, and socioeconomic and civil status), cognitive-affective behavioral patterns (AUD severity, abstinence duration, psychiatric comorbidity, state anxiety, attentional bias, and substance use), and type of treatment (TAU + VR-CET and only TAU', 'alcohol craving', 'levels of alcohol craving', 'craving levels', 'Alcohol Craving Levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",42.0,0.0146005,Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503).,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hernández-Serrano', 'Affiliation': ""Department of Physical Therapy, Escola Universitària de la Salut i l'Esport (EUSES)-University of Girona, Carrer Francesc Macià, 65, Campus of Salt, 17190 Girona PC, Spain.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ghiţă', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Natàlia', 'Initials': 'N', 'LastName': 'Figueras-Puigderrajols', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Fernández-Ruiz', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Monras', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lluïsa', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mondon', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Teixidor', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Gual', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ugas-Ballester', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Montserrat', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Porras-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrer-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gutiérrez-Maldonado', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9093018']
2780,32963266,Local anaesthesia decreases nerve growth factor induced masseter hyperalgesia.,"The aim of this investigation was to evaluate the effects of local anaesthesia on nerve growth factor (NGF) induced masseter hyperalgesia. Healthy participants randomly received an injection into the right masseter muscle of either isotonic saline (IS) given as a single injection (n = 15) or an injection of NGF (n = 30) followed by a second injection of lidocaine (NGF + lidocaine; n = 15) or IS (NGF + IS; n = 15) in the same muscle 48 h later. Mechanical sensitivity scores of the right and left masseter, referred sensations and jaw pain intensity and jaw function were assessed at baseline, 48 h after the first injection, 5 min after the second injection and 72 h after the first injection. NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups. However, the mechanical sensitivity of the right masseter 5 min after the second injection in the NGF + lidocaine group was significantly lower than the second injection in the NGF + IS and was similar to the IS group. There were no significant differences for the referred sensations. Local anaesthetics may provide relevant information regarding the contribution of peripheral mechanisms in the maintenance of persistent musculoskeletal pain.",2020,"NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups.",['Healthy participants'],"['NGF\u2009+\u2009lidocaine', 'NGF', 'lidocaine (NGF\u2009+\u2009lidocaine; n\u2009=\u200915) or IS (NGF\u2009+\u2009IS; n\u2009=\u200915) in the same muscle 48\xa0h later', 'isotonic saline (IS) given as a single injection (n\u2009=\u200915) or an injection of NGF', 'local anaesthesia', 'lidocaine']","['jaw pain evoked by chewing', 'mechanical sensitivity', 'Mechanical sensitivity scores of the right and left masseter, referred sensations and jaw pain intensity and jaw function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0236000', 'cui_str': 'Jaw pain'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0446219,"NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups.","[{'ForeName': 'Yuri M', 'Initials': 'YM', 'LastName': 'Costa', 'Affiliation': 'Department of Biosciences, Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Piracicaba, CEP 13414-903, Brazil. yuricosta@fop.unicamp.br.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Castrillon', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Paulo César R', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Scientific reports,['10.1038/s41598-020-71620-8']
2781,32963294,Omega-3 index and blood pressure responses to eating foods naturally enriched with omega-3 polyunsaturated fatty acids: a randomized controlled trial.,"Diets low in seafood omega-3 polyunsaturated fatty acids (PUFAs) are very prevalent. Such diets have recently been ranked as the sixth most important dietary risk factor-1.5 million deaths and 33 million disability-adjusted life-years worldwide are attributable to this deficiency. Wild oily fish stocks are insufficient to feed the world's population, and levels of eicosapentaenoic acid and docosahexaenoic acid (DHA) in farmed fish have more than halved in the last 20 years. Here we report on a double-blinded, controlled trial, where 161 healthy normotensive adults were randomly allocated to eat at least three portions/week of omega-3-PUFA enriched (or control) chicken-meat, and to eat at least three omega-3-PUFA enriched (or control) eggs/week, for 6 months. We show that regular consumption of omega-3-PUFA enriched chicken-meat and eggs significantly increased the primary outcome, the red cell omega-3 index (mean difference [98.75% confidence interval] from the group that ate both control foods, 1.7% [0.7, 2.6]). Numbers of subjects with a very high-risk omega-3 index (index < 4%) were more than halved amongst the group that ate both enriched foods. Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]). We conclude that chicken-meat and eggs, naturally enriched with algae-sourced omega-3-PUFAs, may serve as alternative dietary sources of these essential micronutrients. Unlike many lifestyle interventions, long-term population health benefits do not depend on willingness of individuals to make long-lasting difficult dietary changes, but on the availability of a range of commonly eaten, relatively inexpensive, omega-3-PUFA enriched foods.",2020,"Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]).","['Numbers of subjects with a very high-risk omega-3 index (index\u2009<\u20094', '161 healthy normotensive adults']","['omega-3-PUFA enriched (or control) chicken-meat, and to eat at least three omega-3-PUFA', 'omega-3 polyunsaturated fatty acids']","['Omega-3 index and blood pressure responses', 'red cell omega-3 index', 'diastolic blood pressure']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677521', 'cui_str': 'Chicken - meat'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",161.0,0.161961,"Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]).","[{'ForeName': 'Alice V', 'Initials': 'AV', 'LastName': 'Stanton', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland. astanton@rcsi.ie.'}, {'ForeName': 'Kirstyn', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Brennan', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': ""O'Donovan"", 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Buskandar', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Shortall', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Thora', 'Initials': 'T', 'LastName': 'El-Sayed', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Devenish Nutrition, Belfast, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hayes', 'Affiliation': 'Devenish Nutrition, Belfast, UK.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Fahey', 'Affiliation': 'University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Pender', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Simon A M', 'Initials': 'SAM', 'LastName': 'Thom', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Moran', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Williams', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Dolan', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}]",Scientific reports,['10.1038/s41598-020-71801-5']
2782,32931457,Yoga-Based Relaxation Technique Facilitates Sustained Attention in Patients with Low Back Pain: A Pilot Study.,"Context


The experience of pain strongly influences sustained attention, which is important for neurocognitive performance. Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain. Hence, we aimed to investigate the effect of a yoga-based relaxation technique on sustained attention and self-reported pain disability in patients with low back pain.
Methods


A total of 22 men aged 30 to 50 years with low back pain were recruited for the study. They were randomly assigned to either the yoga (n = 11) or control (n = 11) groups. The yoga group practiced a yoga-based relaxation technique (YBRT) 1 hour a day for 4 weeks and the control group maintained their usual physical activity regimen. Assessments included the Sustained Attention to Response Task (SART) and the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) measured before and after the 4-week intervention.
Results


The study showed a significant reduction in all self-reported OLBPDQ domains and improvement in sustained attention in a before and after comparison 4 weeks following the yoga intervention. Pearson's correlation also showed a positive correlation between sustained attention and pain reduction following the yoga intervention.
Conclusion


The findings indicate that yoga practice reduces pain and simultaneously improves information processing speed with impulse control during the performance of a sustained attention task.",2020,Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain.,"['Patients with Low Back Pain', '22 men aged 30 to 50 years with low back pain were recruited for the study', 'patients with low back pain']","['Yoga-Based Relaxation Technique', 'Yoga-based relaxation techniques', 'yoga-based relaxation technique', 'yoga group practiced a yoga-based relaxation technique (YBRT']","['pain reduction', 'sustained attention and self-reported pain disability', 'Sustained Attention to Response Task (SART) and the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ', 'OLBPDQ domains and improvement in sustained attention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",22.0,0.0391434,Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain.,"[{'ForeName': 'Dwivedi', 'Initials': 'D', 'LastName': 'Krishna', 'Affiliation': ''}, {'ForeName': 'Singh', 'Initials': 'S', 'LastName': 'Deepeshwar', 'Affiliation': ''}, {'ForeName': 'Bharati', 'Initials': 'B', 'LastName': 'Devi', 'Affiliation': ''}]",Advances in mind-body medicine,[]
2783,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
2784,32933124,Are Respiratory Responses to Cold Air Exercise Different in Females Compared to Males? Implications for Exercise in Cold Air Environments.,"Research has shown that cold air exercise causes significant respiratory dysfunction, especially in female athletes. However, how female and male athletes respond to cold air exercise is not known. Thus, we aimed to compare acute respiratory responses (function, recovery and symptoms) in males and females after high-intensity cold air exercise. Eighteen (nine female) athletes completed two environmental chamber running trials at 0 °C and -20 °C (humidity 34 ± 5%) on different days in a randomized starting order. Spirometry was performed pre, 3, 6, 10, 15 and 20 min post. Respiratory symptoms were measured posttrial and heart rate and rating of perceived exertion were assessed during each trial. No significant differences in delta change (pre to post) were found at either temperature between sexes for FEV 1 , FVC, FEF50% and FEF25-75%. At -20 °C, FEV 1  decreased similarly in both sexes (males: 7.5%, females: 6.3%) but not at 0 °C,  p  = 0.003. Postexertion respiratory function recovery and reported symptoms were not different between sexes at either temperature. These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise. However, intense exercise at -20 °C is challenging to the respiratory system in both sexes and may lead to altered respiratory responses compared to mild winter conditions like 0 °C.",2020,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","['Eighteen (nine female) athletes completed two environmental chamber running trials at 0', 'males and females after high-intensity cold air exercise', 'female and male athletes', 'female athletes']",['cold air exercise'],"['acute respiratory responses (function, recovery and symptoms) to cold air exercise', 'delta change', 'acute respiratory responses (function, recovery and symptoms', 'posttrial and heart rate and rating of perceived exertion']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004179', 'cui_str': 'Atmosphere Exposure Chambers'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0448314,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB T6G 2H9, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lenz', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Faulhaber', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17186662']
2785,32934291,Fine scale spatial investigation of multiple insecticide resistance and underlying target-site and metabolic mechanisms in Anopheles gambiae in central Côte d'Ivoire.,"Routine monitoring of occurrence, levels and mechanisms of insecticide resistance informs effective management strategies, and should be used to assess the effect of new tools on resistance. As part of a cluster randomised controlled trial evaluating a novel insecticide-based intervention in central Côte d'Ivoire, we assessed resistance and its underlying mechanisms in Anopheles gambiae populations from a subset of trial villages. Resistance to multiple insecticides in An. gambiae s.s. and An. coluzzii was detected across villages, with dose-response assays demonstrating extremely high resistance intensity to the pyrethroid deltamethrin (> 1,500-fold), and mortality following exposure to pyrethroid-treated bednets was low (< 30% mortality in cone bioassays). The 1014F kdr mutation was almost fixed (≥ 90%) in all villages but the 1575Y kdr-amplifying mutation was relatively rare (< 15%). The carbamate and organophosphate resistance-associated Ace-1 G119S mutation was also detected at moderate frequencies (22-43%). Transcriptome analysis identified overexpression of P450 genes known to confer pyrethroid resistance (Cyp9K1, Cyp6P3, and Cyp6M2), and also a carboxylesterase (COEAE1F) as major candidates. Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02). Tools and strategies to mitigate the extreme and multiple resistance provided by these mechanisms are required in this area to avoid future control failures.",2020,"Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02).","['Anopheles gambiae populations from a subset of trial villages', ""Anopheles gambiae in central Côte d'Ivoire""]",['novel insecticide-based intervention'],"['deltamethrin resistance intensity', 'Cyp6P3 expression', 'carbamate and organophosphate resistance-associated Ace-1 G119S mutation']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0057233', 'cui_str': 'decamethrin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006948', 'cui_str': 'Carbamates'}, {'cui': 'C0031701', 'cui_str': 'Phosphoric acid ester'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0429302,"Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02).","[{'ForeName': 'Welbeck A', 'Initials': 'WA', 'LastName': 'Oumbouke', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK. welbeck.oumbouke@lshtm.ac.uk.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pignatelli', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Antoine M G', 'Initials': 'AMG', 'LastName': 'Barreaux', 'Affiliation': 'School of Biological Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Innocent Z', 'Initials': 'IZ', 'LastName': 'Tia', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Alphonsine A', 'Initials': 'AA', 'LastName': 'Koffi', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Ludovic P', 'Initials': 'LP', 'LastName': 'Ahoua Alou', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Eleanore D', 'Initials': 'ED', 'LastName': 'Sternberg', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Thomas', 'Affiliation': 'Department of Entomology, Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA, 16802, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weetman', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': ""N'Guessan"", 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}]",Scientific reports,['10.1038/s41598-020-71933-8']
2786,32934794,Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.,"Background:  Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  Methods:  This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates.  Ethics and dissemination:  This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media.  Registration:  ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.",2019,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","['older adults', 'patient-care programs and family members for high-risk patients', 'High-risk, non-cardiac surgery patients (≥70 years old']","['usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system']","['incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates', 'presence of delirium, defined by positive long-form Confusion Assessment Method screening', 'additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3874055', 'cui_str': 'Paging system'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.190457,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","[{'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Vlisides', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Ragheb', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Aleda', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schoettinger', 'Affiliation': 'Department of Social Work, Michigan Medicine, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Zierau', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Norcott', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}]",F1000Research,['10.12688/f1000research.20597.2']
2787,32936837,Implementation of a complex intervention to improve care for patients whose situations are clinically uncertain in hospital settings: A multi-method study using normalisation process theory.,"PURPOSE


To examine the use of Normalisation Process Theory (NPT) to establish if, and in what ways, the AMBER care bundle can be successfully normalised into acute hospital practice, and to identify necessary modifications to optimise its implementation.
METHOD


Multi-method process evaluation embedded within a mixed-method feasibility cluster randomised controlled trial in two district general hospitals in England. Data were collected using (i) focus groups with health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review. Thematic analysis and descriptive statistics, with interpretation guided by NPT components (coherence; cognitive participation; collective action; reflexive monitoring). Data triangulated across sources.
RESULTS


Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted. While coherence was evident, with HPs recognising the value of the AMBER care bundle, cognitive participation and collective action presented challenges. Specifically: (1) HPs were unable and unwilling to operationalise the concept of 'risk of dying' intervention eligibility criteria (2) integration relied on a 'champion' to drive participation and ensure sustainability; and (3) differing skills and confidence led to variable engagement with difficult conversations with patients and families about, for example, nearness to end of life. Opportunities for reflexive monitoring were not routinely embedded within the intervention. Reflections on the use of the AMBER care bundle from HPs and patients and families, including recommended modifications became evident through this NPT-driven analysis.
CONCLUSION


To be successfully normalised, new clinical practices, such as the AMBER care bundle, must be studied within the wider context in which they operate. NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.",2020,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"['Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted', 'two district general hospitals in England', 'patients whose situations are clinically uncertain in hospital settings']","['Normalisation Process Theory (NPT', 'complex intervention', 'health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review', 'NPT']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0589031', 'cui_str': 'Team meeting'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",[],2.0,0.0411618,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"[{'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yorganci', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Fliss E M', 'Initials': 'FEM', 'LastName': 'Murtagh', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'Marie Curie Palliative Care Research Department, University College London, London, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Droney', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Koffman', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}]",PloS one,['10.1371/journal.pone.0239181']
2788,32938990,Modulation of TRPV-1 by prostaglandin-E 2  and bradykinin changes cough sensitivity and autonomic regulation of cardiac rhythm in healthy subjects.,"A neurogenic pathway, involving airway TRPV-1, has been implicated in acute cardiovascular events occurring after peaks of air pollution. We tested whether inhaled prostaglandin-E 2  (PGE 2 ) and bradykinin (BK) regulate TRPV-1 activity in vivo by changing cough response to capsaicin (CPS) and affecting heart rate variability (HRV), while also taking into account the influence of TRPV-1 polymorphisms (SNPs). Moreover, we assessed the molecular mechanism of TRPV-1 modulation in vitro. Seventeen healthy volunteers inhaled 100 μg PGE 2 , 200 μg BK or diluent in a randomized double-blind fashion. Subsequently, the response to CPS was assessed by cough challenge and the sympathetic activity by HRV, expressed by low (nLF) and high (nHF) normalized frequency components, as well as nLF/nHF ratio. Intracellular [Ca 2+ ] was measured in HeLa cells, transfected with wild-type TRPV-1, pre-treated with increasing doses of PGE 2 , BK or diesel exhaust particulate (DEP), after CPS stimulation. Six functional TRPV-1 SNPs were characterized in DNA from each subject. Inhalation of PGE 2  and BK was associated with significant increases in cough response induced by 30 μM of CPS (cough number after PGE 2  = 4.20 ± 0.42; p < 0.001, and after BK = 3.64 ± 0.37; p < 0.01), compared to diluent (2.77 ± 0.29) and in sympathetic activity (nLF/nHF ratio after PGE 2  = 6.1; p < 0.01, and after BK = 4.2; p < 0.05), compared to diluent (2.5-3.3). No influence of SNPs was observed on autonomic regulation and cough sensitivity. Unlike PGE 2  and BK, DEP directly activated TRPV-1. Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.",2020,Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.,"['Seventeen healthy volunteers inhaled 100\xa0μg PGE 2 , 200\xa0μg', 'healthy subjects']","['BK or diluent', 'inhaled prostaglandin-E 2  (PGE 2 ) and bradykinin (BK', 'SNPs', 'capsaicin (CPS', 'TRPV-1 by prostaglandin-E 2  and bradykinin']","['cough response', 'heart rate variability (HRV', 'Intracellular ', 'autonomic regulation and cough sensitivity', 'sympathetic activity (nLF/nHF ratio']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0006100', 'cui_str': 'Kallidin I'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",17.0,0.0833612,Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Liviero', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Scarpa', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'De Stefani', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padua, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Folino', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Campisi', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mason', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'Iliceto', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pavanello', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy. sofia.pavanello@unipd.it.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Maestrelli', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}]",Scientific reports,['10.1038/s41598-020-72062-y']
2789,32939927,"Comment on ""The effect of using a mobile application ('WhiteTeeth') on improving oral hygiene: A randomized controlled trial"" by Scheerman et al.",,2020,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","['2,3', 'adolescent patients', 'adolescent patients with orthodontic fixed appliances', '132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the']","['control group (CG) without the mHealth program', 'mobile application (""WhiteTeeth']","['plaque index and gingival index', 'oral hygiene']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",132.0,0.0255747,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Myoken', 'Affiliation': 'Private Practice Myoken Dental Clinic, Hiroshima, Japan.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Myoken', 'Affiliation': 'Department of Oral Surgery, Hiroshima Red Cross & Atomic-bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Toratani', 'Affiliation': 'Department of Molecular Oral Medicine and Maxillofacial Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12464']
2790,32942730,Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt.,"Wearable technologies provide many possibilities for applications in medicine, and especially in physiotherapy, where tracking and evaluation of body motion are of utmost importance. Despite the existence of multiple smart garments produced for applications in physiotherapy, there is limited information available on the actual impact of these technologies on the clinical outcomes. The objective of this paper is to evaluate the impact of the Double Aid (DAid) smart shirt, a purely textile-based system, on the training process of patients with subacromial pain syndrome. A randomized controlled trial was performed where patients with subacromial pain syndrome had to perform the assigned training exercises while employing the DAid smart shirt system. The core point of each exercise was to perform a movement while holding the shoulders stationary. The smart shirt was designed to sense even slight shoulder motion thus providing the patient with feedback on the accuracy of the motion, and allowing the patient to adjust the movement. The appropriate muscles should be strengthened through an increased effort to control the shoulder motion. The recovery of patients using the feedback system at the end of the treatment was compared to that of a reference group through standardized tests-the Disabilities of the Arm, Shoulder, and Hand score (DASH score), Closed Kinetic Chain Upper Extremity Stability test (CKCUES test), and internal/external rotation ratio. The test group that used the DAid system demonstrated significantly better results of the performed tests for all applied outcome measures compared to the reference group ( p  < 0.001). An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.",2020,An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.,"['Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt', 'patients with subacromial pain syndrome']",['training exercises while employing the DAid smart shirt system'],"['Hand score (DASH score), Closed Kinetic Chain Upper Extremity Stability test (CKCUES test), and internal/external rotation ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0332092,An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.,"[{'ForeName': 'Guna', 'Initials': 'G', 'LastName': 'Semjonova', 'Affiliation': 'Department of Morphology, Faculty of Medicine, Riga Stradins University, LV-1010 Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Vetra', 'Affiliation': 'Department of Morphology, Faculty of Medicine, Riga Stradins University, LV-1010 Riga, Latvia.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Cauce', 'Affiliation': 'Statistics Unit, Faculty of Medicine, Riga Stradins University, LV-1046 Riga, Latvia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Oks', 'Affiliation': 'Institute of Design Technologies, Riga Technical University, LV-1048 Riga, Latvia.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Katashev', 'Affiliation': 'Institute of Biomedical Engineering and Nanotechnology, Riga Technical University, LV-1048 Riga, Latvia.'}, {'ForeName': 'Peteris', 'Initials': 'P', 'LastName': 'Eizentals', 'Affiliation': 'Institute of Biomedical Engineering and Nanotechnology, Riga Technical University, LV-1048 Riga, Latvia.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185277']
2791,32944806,Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial.,"Repetitive transcranial magnetic stimulation (rTMS) has been proposed as an alternative option for treating tinnitus. rTMS is a noninvasive method in which repetitive magnetic stimulation is applied to the cortex; it is considered a therapeutic strategy that modulates the loudness of tinnitus. In this study, we performed a double-blind randomized clinical trial to compare the outcome of tinnitus treatment among (1) dual-site (auditory + prefrontal) rTMS stimulation, (2) auditory cortex only rTMS stimulation (AC), and (3) sham stimulation. The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality. Dual-site and auditory only groups were treated with a total of 12,000 pulses, 2000 pulses over the AC and 1000 pulses over the DLPFC (group 1), 3000 pulses over the AC only (group 2), and daily for 4 consecutive days. Dual-site group exhibited a significantly better ΔTinnitus Handicap Inventory (ΔTHI) score at 4, 8 weeks and 12 weeks after rTMS treatments compared with pre-treatment. However, there was no effect in the auditory only group. Also, there was no effect in sham group when THI scores were compared with that of the pre-treatment. These results are in line with the former studies that reported a better treatment effect by multiple site rTMS.",2020,The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality.,['Tinnitus Patients'],"['tinnitus treatment among (1) dual-site (auditory\u2009+\u2009prefrontal) rTMS stimulation, (2) auditory cortex only rTMS stimulation (AC), and (3) sham stimulation', 'Dual-site rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['THI scores', 'ΔTinnitus Handicap Inventory (ΔTHI) score']","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0272238', 'cui_str': 'Transient hypogammaglobulinemia of infancy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",12000.0,0.139234,The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality.,"[{'ForeName': 'Tae-Soo', 'Initials': 'TS', 'LastName': 'Noh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Jeong-Sug', 'Initials': 'JS', 'LastName': 'Kyong', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, Audiology Institute, Hallym University of Graduate Studies, Seoul, Korea.'}, {'ForeName': 'Moo Kyun', 'Initials': 'MK', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Seung Ha', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Myung-Whan', 'Initials': 'MW', 'LastName': 'Suh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea. drmung@naver.com.'}]",Brain topography,['10.1007/s10548-020-00797-y']
2792,32941530,"Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial.","BACKGROUND


Early childhood is a critical period for the development of obesity, with new approaches to prevent obesity in this age group needed. We designed and piloted the 3 Pillars Study (3PS), a healthy lifestyle programme informed by attachment theory for parents of preschool-aged children.
METHODS


A 2-arm, randomised controlled pilot study was conducted to assess the effectiveness of 3PS, a 6-week programme involving a half-day workshop plus 6-week access to a study website. The programme was designed to promote routines around healthy lifestyle behaviours, including sleep, limited screen use, and family meals, within the context of positive, reciprocal parent-child interactions. Parents (n = 54) of children aged 2-4 years who regularly exceeded screen use recommendations (≥1 hour per day), were randomised to the 3PS programme (n = 27) or a wait-list control group (n = 27). Child screen time at 6 weeks was the primary endpoint. Frequency of family meals, parent feeding practices, diet quality, sleep, Child Routine Inventory (to assess predictability of commonly occurring routines), and household chaos were also assessed. Study data were collected online at baseline, 6 weeks, and 12 weeks via REDCap.
RESULTS


No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group. Compared with controls, the intervention group demonstrated significant improvements from baseline in household chaos scores (i.e. a reduction in chaos) and a number of measures of sleep outcomes, indicating improved sleep continuity. The programme was highly acceptable to parents.
CONCLUSIONS AND RECOMMENDATIONS


A relational approach appears promising as a novel way to promote healthy lifestyle behaviours associated with the prevention of childhood obesity in children aged 2-4 years. A larger study is warranted.",2020,"No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group.","['for parents of preschool-aged children', 'parents of preschool-aged children', 'children aged 2-4 years', 'Parents (n = 54) of children aged 2-4 years who regularly exceeded screen use recommendations ']","['3PS', '3PS programme', 'healthy lifestyle programme informed by attachment theory']","['screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration', 'Child screen time', 'sleep continuity', 'household chaos scores', 'number of measures of sleep outcomes', 'Frequency of family meals, parent feeding practices, diet quality, sleep, Child Routine Inventory (to assess predictability of commonly occurring routines), and household chaos']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.100448,"No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Marsh', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gerritsen', 'Affiliation': 'Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",PloS one,['10.1371/journal.pone.0238977']
2793,32946885,Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain. Electronic address: cristinamaria.lozano@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
2794,32946978,Sensory attributes of coated tablets: Developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
2795,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2796,32966280,Molecular classification of the placebo effect in nausea.,"In this proof-of-concept study, we tested whether placebo effects can be monitored and predicted by plasma proteins. In a randomized controlled design, 90 participants were exposed to a nauseating stimulus on two separate days and were randomly allocated to placebo treatment or no treatment on the second day. Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified. Using label-free tandem mass spectrometry, 74 differentially regulated proteins were identified as correlates of the placebo effect. Gene ontology (GO) enrichment analyses identified acute-phase proteins and microinflammatory proteins to be involved, and the identified GO signatures predicted day-adjusted scores of nausea indices in the placebo group. We also performed GO enrichment analyses of specific plasma proteins predictable by the experimental factors or their interactions and identified 'grooming behavior' as a prominent hit. Finally, Receiver Operator Characteristics (ROC) allowed to identify plasma proteins differentiating placebo responders from non-responders, comprising immunoglobulins and proteins involved in oxidation reduction processes and complement activation. Plasma proteomics is a promising tool to identify molecular correlates and predictors of the placebo effect in humans.",2020,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.",['90 participants were exposed to a nauseating stimulus on two separate days'],['placebo'],"['nausea', 'nausea, motion sickness, and (in females) gastric activity']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",90.0,0.243193,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Lutter', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'von Toerne', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haile', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Metabolic Diseases Institute, University of Cincinnati, Cincinnati, Ohio, United States of America.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Hoffmann', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Uli', 'Initials': 'U', 'LastName': 'Ohmayer', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Stefanie M', 'Initials': 'SM', 'LastName': 'Hauck', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Matthias H', 'Initials': 'MH', 'LastName': 'Tschoep', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}]",PloS one,['10.1371/journal.pone.0238533']
2797,32968171,The effect of transcranial random noise stimulation (tRNS) over bilateral posterior parietal cortex on divergent and convergent thinking.,"Creativity pervades many areas of everyday life and is considered highly relevant in several human living domains. Previous literature suggests that the posterior parietal cortex (PPC) is related to creativity. However, none of previous studies have compared the effect of transcranial random noise stimulation (tRNS) over bilateral PPC on both verbal and visual divergent thinking (DT) and Remote Associates Test (RAT) in the same experimental design. Forty healthy participants were randomly assigned to tRNS (100-500 Hz) over bilateral PPC or sham group, for 15 min and current was set at 1.5 mA. Participants' creativity skills were assessed before and after brain stimulation with the Unusual Uses and the Picture Completion subtests from the Torrance Test of Creative Thinking and the RAT. ANCOVA (baseline scores as covariate) results indicated that tRNS group had significantly higher scores at post-test in RAT and visual originality compared to sham group. Unusual Uses, on the other hand, was not significant. Improvement in RAT suggests the involvement of PPC during via insight solution which may reflect internally directed attention that helps the recombination of remotely associated information. The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.",2020,The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.,['Forty healthy participants'],"[""bilateral PPC or sham group, for 15\xa0min and current was set at 1.5\xa0mA. Participants' creativity skills were assessed before and after brain stimulation with the Unusual Uses and the Picture Completion subtests from the Torrance Test of Creative Thinking and the RAT"", 'tRNS', 'transcranial random noise stimulation (tRNS']",['visual originality dimension'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",40.0,0.116756,The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain. javier.pena@deusto.es.'}, {'ForeName': 'Agurne', 'Initials': 'A', 'LastName': 'Sampedro', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Ibarretxe-Bilbao', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Zubiaurre-Elorza', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Aralar', 'Initials': 'A', 'LastName': 'Aizpurua', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ojeda', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}]",Scientific reports,['10.1038/s41598-020-72532-3']
2798,32933953,Protocol for the impact of CBT for insomnia on pain symptoms and central sensitisation in fibromyalgia: a randomised controlled trial.,"INTRODUCTION


Approximately 50% of individuals with fibromyalgia (a chronic widespread pain condition) have comorbid insomnia. Treatment for these comorbid cases typically target pain, but growing research supports direct interventions for insomnia (eg, cognitive behavioural treatment for insomnia (CBT-I)) in these patients. Previous research suggests sustained hyperarousal mediated by a neural central sensitisation mechanism may underlie insomnia and chronic pain symptoms in fibromyalgia. We hypothesise CBT-I will improve insomnia symptoms, improve clinical pain and reduce central sensitisation. The trial will be the first to evaluate the short-term and long-term neural mechanisms underlying insomnia and pain improvements in fibromyalgia. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target pain mechanisms, perhaps reversing chronic pain or preventing it.
METHODS AND ANALYSIS


Female participants (n=130) 18 years of age and older with comorbid fibromyalgia (with pain severity of at least 50/100) and insomnia will be recruited from the University of Missouri in Columbia, Missouri, and surrounding areas. Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH). Participants will be assessed at baseline, post-treatment, 6 and 12 months follow-ups. The following assessments will be completed: 2 weeks of daily diaries measuring sleep and pain, daily actigraphy, insomnia severity index, pain-related disability, single night of polysomnography recording, arousal (heart rate variability, cognitive affective arousal), structural and functional MRI to examine pain-related neural activity and plasticity and mood (depression, anxiety).
ETHICS AND DISSEMINATION


Ethics approval was obtained in July 2018 from the University of Missouri. All data are expected to be collected by 2022. Full trial results are planned to be published by 2024. Secondary analyses of baseline data will be subsequently published.
TRIAL REGISTRATION NUMBER


NCT03744156.",2020,Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH).,"['individuals with fibromyalgia (a chronic widespread pain condition', 'Ethics approval was obtained in July 2018 from the University of Missouri', 'fibromyalgia', 'Female participants (n=130) 18 years of age and older with comorbid fibromyalgia (with pain severity of at least 50/100) and insomnia will be recruited from the University of Missouri in Columbia, Missouri, and surrounding areas']","['CBT', 'CBT-I or a sleep hygiene control group (SH']","['pain symptoms and central sensitisation', 'sleep and pain, daily actigraphy, insomnia severity index, pain-related disability, single night of polysomnography recording, arousal (heart rate variability, cognitive affective arousal), structural and functional MRI to examine pain-related neural activity and plasticity and mood (depression, anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C3178789', 'cui_str': 'Amplified musculoskeletal pain syndrome'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.399601,Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH).,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri System, Columbia, Missouri, USA mccraec@health.missouri.edu.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Departments of Psychiatry and Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Craggs', 'Affiliation': 'Departments of Physical Therapy and Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Deroche', 'Affiliation': 'Department of Health Management and Informatics, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Sahota', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Chokkalingam', 'Initials': 'C', 'LastName': 'Siva', 'Affiliation': 'Division of Immunology and Rheumatology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Rheumatology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033760']
2799,32933954,Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression.,"OBJECTIVES


We report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi-country cOllaborative project on the rOle of Diet, Food-related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.
DESIGN


Randomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.
SETTING


Germany, the Netherlands, UK and Spain.
PARTICIPANTS


Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18-75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.
INTERVENTIONS


Daily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome: self-reported acceptability of the interventions.
SECONDARY OUTCOMES


adherence and self-reported depressive symptoms.
RESULTS


Most participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=-0.08, SE=0.03, p = 0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.
CONCLUSIONS


F-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.
TRIAL REGISTRATION NUMBER


NCT02529423.",2020,Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%).,"['2×2 factorial design conducted between 2015 and 2017', 'overweight adults with subsyndromal symptoms of depression', 'Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder', 'Germany, the Netherlands, UK and Spain', 'MooDFOOD Trial', 'Main eligibility criteria included age (18-75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5']","['Daily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention']","['adherence and self-reported depressive symptoms', 'self-reported acceptability of the interventions', 'Acceptability and feasibility', 'F-BA', 'depressive symptoms irrespective of adherence', 'depressive symptoms', 'history of depression']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}]",1025.0,0.417814,Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%).,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK m.owens-solari@exeter.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg Annemarie', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Cabout', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034025']
2800,32933955,"Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01 E  vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention.","INTRODUCTION


Seasonal malaria chemoprevention (SMC), with sulphadoxine-pyrimethamine plus amodiaquine (SP+AQ) is effective but does not provide complete protection against clinical malaria. The RTS,S/AS01 E  malaria vaccine provides a high level of protection shortly after vaccination, but this wanes rapidly. Such a vaccine could be an alternative or additive to SMC. This trial aims to determine whether seasonal vaccination with RTS,S/AS01 E  vaccine could be an alternative to SMC and whether a combination of the two interventions would provide added benefits.
METHODS AND ANALYSIS


This is an individually randomised, double-blind, placebo-controlled trial. 5920 children aged 5-17 months were enrolled in April 2017 in Mali and Burkina Faso. Children in group 1 received three priming doses of RTS,S/AS01 E  vaccine before the start of the 2017 malaria transmission season and a booster dose at the beginning of two subsequent transmission seasons. In addition, they received SMC SP+AQ placebo on four occasions each year. Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year. Children in group 3 received RTS,S/AS01 E  vaccine and four courses of SMC SP+AQ. Incidence of clinical malaria is determined by case detection at health facilities. Weekly active surveillance for malaria is undertaken in a randomly selected subset of children. The prevalence of malaria is measured in surveys at the end of each transmission season. The primary endpoint is the incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL. Primary analysis will be by modified intention to treat defined as children who have received the first dose of the malaria or control vaccine.
ETHICS AND DISSEMINATION


The protocol was approved by the national ethics committees of Mali and Burkina Faso and the London School of Hygiene and Tropical Medicine. The results will be presented to all stakeholders and published in open access journals.
TRIAL REGISTRATION NUMBER


NCT03143218; Pre-results.",2020,Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year.,['5920 children aged 5-17 months were enrolled in April 2017 in Mali and Burkina Faso'],"['rabies vaccine', 'SMC SP+AQ placebo', 'placebo', 'SMC SP+AQ', 'sulphadoxine-pyrimethamine plus amodiaquine (SP+AQ', 'RTS,S/AS01 E  vaccine']","['incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL', 'prevalence of malaria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",5920.0,0.427938,Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK Daniel.Chandramohan@lshtm.ac.uk.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Djibrilla', 'Initials': 'D', 'LastName': 'Issiaka', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Koualy', 'Initials': 'K', 'LastName': 'Sanogo', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Almahamoudou', 'Initials': 'A', 'LastName': 'Mahamar', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Sompougdou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Opokua', 'Initials': 'O', 'LastName': 'Ofori-Anyinam', 'Affiliation': 'GlaxoSmithKline Biologicals SA, Wavre, Belgium.'}, {'ForeName': 'Jean-Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035433']
2801,32935565,Assessment of the Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy for the Treatment of Patients with Nondilated Collecting System.,"Purpose:  To investigate the clinical value of contrast-enhanced ultrasound (CEUS) in percutaneous nephrolithotomy (PCNL) for kidney stone patients without hydronephrosis.  Methods:  Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study. Patients who met the inclusion criteria were randomized into two groups: a CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group. The operation results of the two groups were compared, including the number of attempts for effective puncture, duration to effective puncture, stone clearance rate, blood loss, postoperative complications, and hospital stay.  Results:  Fifty-six patients with a nondilated collecting system who underwent PCNL for 60 kidneys were included in this study, including 4 patients who underwent bilateral PCNL due to bilateral renal stones. There were 30 kidneys in each group. All patients successfully underwent PCNL. The CEUS-guided PCNL group had more accurate punctures, with a higher effective rate of one puncture and shorter puncture time. There was no statistically significant difference in stone clearance rate between the two groups. Four cases of double channels were established in the conventional US-guided PCNL group, while there was only one case in the CEUS-guided PCNL group. In the CEUS-guided PCNL group, most cases (96.7%, 29/30) had no or only mild complications, which were significantly better than the conventional US-guided PCNL group (76.7%, 23/30). The mean postoperative hemoglobin loss in the CEUS-guided PCNL group was 9.5 (range 1-25) g/L, which was significantly lower than 15.5 (range 5-52) g/L in the conventional US-guided PCNL group.  Conclusion:  The CEUS technique can improve visibility of the nondilated renal collecting system, facilitate selection of suitable calix, and identify renal calix fornix. It also benefits needle placement in patients with a nondilated collecting system.",2020,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","['Fifty-six patients with a nondilated collecting system who underwent PCNL for sixty kidneys', 'Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study', 'kidney stone patients without hydronephrosis', 'Patients who met the inclusion criteria', 'patients with a nondilated collecting system', 'Patients with Nondilated Collecting System']","['CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group', 'contrast-enhanced ultrasound (CEUS', 'Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy', 'PCNL', 'percutaneous nephrolithotomy (PCNL', 'bilateral PCNL']","['mild complications', 'number of attempts for successful puncture, duration to successful puncture, stone clearance rate, blood loss, postoperative complications and hospital stay', 'successful rate of one puncture and shorter puncture time', 'mean postoperative hemoglobin loss', 'bilateral renal stones', 'stone clearance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]",56.0,0.0184341,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","[{'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zonglai', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xiaozhan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Ultrasound, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ai', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Ziqiu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}]",Journal of endourology,['10.1089/end.2020.0564']
2802,32937988,Mitochondrial DNA Parameters in Blood of Infants Receiving Lopinavir/Ritonavir or Lamivudine Prophylaxis to Prevent Breastfeeding Transmission of HIV-1.,"Children who are human immunodeficiency virus (HIV)-exposed but uninfected (CHEU) accumulate maternal HIV and antiretroviral exposures through pregnancy, postnatal prophylaxis, and breastfeeding. Here, we compared the dynamics of mitochondrial DNA (mtDNA) parameters in African breastfed CHEU receiving lopinavir/ritonavir (LPV/r) or lamivudine (3TC) pre-exposure prophylaxis during the first year of life. The number of mtDNA copies per cell (MCN) and the proportion of deleted mtDNA (MDD) were assessed at day 7 and at week 50 post-delivery (PrEP group). mtDNA depletion was defined as a 50% or more decrease from the initial value, and mtDNA deletions was the detection of mtDNA molecules with large DNA fragment loss. We also performed a sub-analysis with CHEU who did not receive a prophylactic treatment in South Africa (control group). From day seven to week 50, MCN decreased with a median of 41.7% (interquartile range, IQR: 12.1; 64.4) in the PrEP group. The proportion of children with mtDNA depletion was not significantly different between the two prophylactic regimens. Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05). Moreover, the proportion of children with MDD was unexpectedly high before randomisation in both groups. Long-term health impacts of these mitochondrial DNA parameters should be investigated further for both CHEU and HIV-infected children receiving LPV/r- or 3TC- based regimens.",2020,"Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05).","['African breastfed CHEU receiving', 'Children who are human immunodeficiency virus (HIV)-exposed but uninfected (CHEU) accumulate maternal HIV and antiretroviral exposures through pregnancy, postnatal prophylaxis, and breastfeeding']","['Lopinavir/Ritonavir or Lamivudine Prophylaxis', 'lopinavir/ritonavir (LPV/r) or lamivudine (3TC']","['mtDNA depletion', 'proportion of children with mtDNA depletion', 'proportion of children with MDD', 'number of mtDNA copies per cell (MCN) and the proportion of deleted mtDNA (MDD']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0342782', 'cui_str': 'Depletion of mitochondrial DNA'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0274673,"Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Monnin', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Centre Hospitalier Universitaire, 34934 Montpellier, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Periès', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Roselyne', 'Initials': 'R', 'LastName': 'Vallo', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso 01 B.P. 390, Burkina Faso.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, Cecilia Makiwane Hospital, University of Fort Hare, East London 5201, South Africa.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala 7062, Uganda.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'Department of Paediatric and Child Health, University Teaching Hospital, Lusaka PO Box 50110, Zambia.'}, {'ForeName': 'Nobubelo', 'Initials': 'N', 'LastName': 'Ngandu', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Cape Town 7501, South Africa.'}, {'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Goga', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Cape Town 7501, South Africa.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Reynier', 'Affiliation': 'Département de Biochimie et Génétique, Centre Hospitalier Universitaire, 49933 Angers, France.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, Faculty of Medicine, University of Bergen, 5009 Bergen, Norway.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van de Perre', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Centre Hospitalier Universitaire, 34934 Montpellier, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Molès', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}]",Journal of clinical medicine,['10.3390/jcm9092972']
2803,32939597,Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"RATIONALE


The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed.
OBJECTIVES


The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality.
METHODS


We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors.
RESULTS


In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p < 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p < 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37).
CONCLUSIONS


Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.",2020,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","['people with insomnia and healthy controls', 'elderly participants with insomnia complaints and age-matched healthy controls']","['zopiclone 7.5 mg and placebo', 'placebo-controlled pharmacological intervention']","['survival dynamics of sleep', 'SOL misperception', 'segment length of wake', 'average segment length of NREM sleep']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.024048,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05660-3']
2804,32943657,A randomized controlled trial of cystoinflation to prevent bladder injury in the adhesive disease of multiple caesarean sections.,"Caesarean sections carry the risk of urinary bladder injury due to formation of adhesions obscuring pelvic planes. Visualizing bladder during retro-fill (cystoinflation) makes it recognizable as it rises into the abdomen taking a tense rounded contour. We conducted a prospective randomized controlled trial to find out whether improved identification of bladder margins by cystoinflation could decrease bladder injury rate and blood loss without causing urological complications. This study included 214 healthy women with previous operative deliveries undergoing elective caesarean section and found to have dense pelvic adhesions. The subjects were randomly allocated into cystoinflation and control groups. Adhesiolysis was performed using bladder retro-fill with 300 cc saline in cystoinflation group, and without retro-fill in control. The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001). Mean operative time was similar in both groups. Urinary tract infection and micturition problems occurred more frequently in control group than cystoinflation group (16.8% vs 1.9%, P = .001 and .47 ± 1.63% vs 077 ± .633%, P = .021 respectively) with fistula in one subject compared to none in cystoinflation group. In this study, cystoinflation was effective to significantly reduce bladder injury rate and blood loss. This technique may also prove useful in the fields of surgery, urology and urogynecology.",2020,"The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001).","['adhesive disease of multiple caesarean sections', '214 healthy women with previous operative deliveries undergoing elective caesarean section and found to have dense pelvic adhesions']",[],"['Urinary tract infection and micturition problems', 'bladder injury rate and blood loss', 'Mean operative time', 'blood loss', 'bladder injury rate']","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3495929', 'cui_str': 'Multiple caesarean sections'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0262591', 'cui_str': 'Pelvic adhesions'}]",[],"[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0241705', 'cui_str': 'Difficulty passing urine'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",214.0,0.0773345,"The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001).","[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Saaqib', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan. shaziasaaqib@gmail.com.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Munazza', 'Initials': 'M', 'LastName': 'Naheed', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Saeed', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Khalid', 'Affiliation': 'Institute of Public Health, Lahore, Pakistan.'}]",Scientific reports,['10.1038/s41598-020-71132-5']
2805,32945875,Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial.,"Importance


Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load.
Objective


To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression.
Design, Setting, and Participants


This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020.
Interventions


Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions.
Main Outcomes and Measures


The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment.
Results


A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
Conclusions and Relevance


In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02720237.",2020,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","['Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included', '440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam', 'Vietnamese Adults With Hazardous Alcohol Use and HIV', '440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4', 'people living with HIV', 'Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020']","['2 Integrated Interventions', 'standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions']","['Viral suppression', 'Alcohol Abstinence and Viral Suppression', 'viral suppression', 'percentage of days abstinent from alcohol', 'mean (SE) percentage of days abstinent', 'percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4706350', 'cui_str': 'AUDIT-C (Alcohol Use Disorders Identification Test - Consumption) score'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}]",440.0,0.0729123,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","[{'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Tran V', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Nguyen V T', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Vinmec Healthcare System, Hanoi, Vietnam.'}, {'ForeName': 'Bui X', 'Initials': 'BX', 'LastName': 'Quynh', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Vu', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Blackburn', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17115']
2806,32942085,A Phase 2 Study of AMO-02 (Tideglusib) in Congenital and Childhood-Onset Myotonic Dystrophy Type 1 (DM1).,"BACKGROUND


GSK3β is an intracellular regulatory kinase that is dysregulated in multiple tissues in type 1 myotonic dystrophy, a rare neuromuscular disorder that manifests at any age. AMO-02 (tideglusib) inhibits GSK3β activity in preclinical models of type 1 myotonic dystrophy and promotes cellular maturation as well as normalizes aberrant molecular and behavioral phenotypes. This phase 2 study assessed the pharmacokinetics, safety and tolerability, and preliminary efficacy of AMO-02 in adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy.
METHODS


Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12 weeks of single-blind fixed-dose oral treatment with either 400 mg (n = 8) or 1000 mg (n = 8) AMO-02 (NCT02858908). Blood samples were obtained for pharmacokinetic assessment. Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning, were obtained.
RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed. AMO-02 was generally safe and well-tolerated. No early discontinuations due to adverse events or dose adjustments of AMO-02 occurred. The majority of subjects manifested clinical improvement in their central nervous system and neuromuscular symptoms after 12 weeks of treatment compared with the placebo baseline, with a larger response noted at the 1000 mg/day dose level. AMO-02 exposure (cumulative area under the curve) was significantly correlated (P < 0.01) with change from baseline on several key efficacy assessments.
CONCLUSION


AMO-02 has favorable pharmacokinetic and clinical risk/benefit profiles meriting further study as a potential treatment for congenital and childhood-onset type 1 myotonic dystrophy.",2020,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","['Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12\xa0weeks of', 'adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy']","['AMO-02', 'AMO-02 (Tideglusib', 'single-blind fixed-dose oral treatment with either 400\xa0mg (n\xa0=\xa08) or 1000\xa0mg (n\xa0=\xa08) AMO-02']","['Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning', 'AMO-02 exposure (cumulative area under the curve', 'central nervous system and neuromuscular symptoms', 'safe and well-tolerated', 'AMO-02 plasma concentrations', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.194485,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK. Electronic address: joe.horrigan@amo-pharma.com.'}, {'ForeName': 'Tiago Bernardino', 'Initials': 'TB', 'LastName': 'Gomes', 'Affiliation': 'John Walton Muscular Dystrophy Research Centre, Institute of Genetic Medicine, Newcastle University, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Nikolenko', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, Queen Square, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McMorn', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Wichita Falls, Texas.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Oosterholt', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lochmüller', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute; Division of Neurology, Department of Medicine, The Ottawa Hospital; and Brain and Mind Research Institute, University of Ottawa, Ottawa, Canada.""}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.08.001']
2807,32948289,Patients with temporomandibular pain who receive propranolol are more likely to experience pain reduction than those who receive a placebo.,,2020,,['Patients with temporomandibular pain who receive'],"['placebo', 'propranolol']",['experience pain reduction'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0263757,,"[{'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Brignardello-Petersen', 'Affiliation': ''}]",Journal of the American Dental Association (1939),['10.1016/j.adaj.2020.07.004']
2808,32946500,Impact of the extension of a performance-based financing scheme to nutrition services in Burundi on malnutrition prevention and management among children below five: A cluster-randomized control trial.,"Malnutrition is a huge problem in Burundi. In order to improve the health system response, the Ministry of Health piloted the introduction of malnutrition prevention and care indicators within its performance-based financing (PBF) scheme. Paying for units of services and for qualitative indicators is expected to enhance provision and quality of these nutrition services. The objective of this study is to assess the impacts of this intervention, on both child acute malnutrition recovery rates at health centre level and prevalence of chronic and acute malnutrition among children at community level. This study follows a cluster-randomized controlled evaluation design: 90 health centres (HC) were randomly selected for the study, 45 of them were randomly assigned to the intervention and received payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation. Data were collected from baseline and follow-up surveys of the 90 health centres and 6,480 households with children aged 6 to 23 months. From the respectively 1,067 and 1,402 moderate and severe acute malnutrition transcribed files and registers, findings suggest that the intervention had a positive impact on moderate acute malnutrition recovery rates (OR: 5.59, p = 0.039 -at the endline, 78% in the control group and 97% in the intervention group) but not on uncomplicated severe acute malnutrition recovery rate (OR: 1.16, p = 0.751 -at the endline, 93% in the control group and 92% in the intervention group). The intervention also had a significant increasing impact on the number of children treated for acute malnutrition. Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp. 8.80% and 49.90% in the control group and 8.70% and 52.0% in the intervention group, the differences being non-significant. PBF can contribute to a better management of malnutrition at HC level; yet, to address the huge problem of child malnutrition in Burundi, additional strategies are urgently required.",2020,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","['children below five', '90 health centres (HC', '6,480 households with children aged 6 to 23 months', 'children at community level', '12,679 children aged 6-23 months']","['payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation', 'PBF']","['uncomplicated severe acute malnutrition recovery rate', 'moderate acute malnutrition recovery rates', 'number of children treated for acute malnutrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]",12679.0,0.0481994,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Korachais', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Nkurunziza', 'Affiliation': 'Global Health Institute, University of Antwerp, Belgium.'}, {'ForeName': 'Manassé', 'Initials': 'M', 'LastName': 'Nimpagaritse', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Meessen', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}]",PloS one,['10.1371/journal.pone.0239036']
2809,32946551,Do home modifications reduce care home admissions for older people? A matched control evaluation of the Care & Repair Cymru service in Wales.,"BACKGROUND


home advice and modification interventions aim to promote independent living for those living in the community, but quantitative evidence of their effectiveness is limited.
AIM


assess the risk of care home admissions for people with different frailty levels receiving home advice and modification interventions against a control group who do not.
STUDY DESIGN AND SETTING


matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice. The intervention group received the Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales.
METHODS


frailty, age and gender were used in propensity score matching to assess the Hazard Ratio (HR) of care home admissions within a 1-, 3- and 5-year period for the intervention group (N = 93,863) compared to a matched control group (N = 93,863). Kaplan-Meier curves were used to investigate time to a care home admission.
RESULTS


the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years [HR (95%CI)] for those classified as fit [1-year: 2.02 (1.73, 2.36), 3-years: 1.87 (1.72, 2.04), 5-years: 1.99 (1.86, 2.13)] and mildly frail [1-year: 1.25 (1.09, 1.42), 3-years: 1.25 (1.17, 1.34), 5-years: 1.30 (1.23, 1.38)], but a reduced risk of care home admission for moderately [1-year: 0.66 (0.58, 0.75), 3-years: 0.75 (0.70, 0.80), 5-years: 0.83 (0.78, 0.88)] and severely frail individuals [1-year: 0.44 (0.37, 0.54), 3-years: 0.54 (0.49, 0.60), 5-years: 0.60(0.55, 0.66)].
CONCLUSIONS


HRs indicated that the C & RC service helped to prevent care home admissions for moderately and severely frail individuals. The HRs generally increased with follow-up duration.",2020,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","['people with different frailty levels receiving home advice and modification interventions against a control group who do not', '5-years', 'matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice']","['C & RC service', 'Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales']","['reduced risk of care home admission', 'risk of a care home admission', 'Hazard Ratio (HR) of care home admissions', 'mildly frail', 'HR (95%CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]",,0.0910446,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hollinghurst', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fry', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Care & Repair Cymru, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hillcoat-Nallétamby', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ronan A', 'Initials': 'RA', 'LastName': 'Lyons', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rodgers', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]",Age and ageing,['10.1093/ageing/afaa158']
2810,32947603,Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial.,"BACKGROUND


Uncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential.
METHODS


Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic.
RESULTS


Ninety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC.
CONCLUSIONS


That the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials.
IMPACT


Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials. We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention. The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.",2020,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"['Ninety-four preterm babies', 'Necrotising enterocolitis']",['Bifidobacterium breve'],"['intestinal barrier function', 'Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation', 'acetic acid levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]","[{'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",94.0,0.042855,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fleming', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK. Paul.fleming@qmul.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilks', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Panton', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hutchinson', 'Affiliation': 'Centre for Genomics and Child Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Abena', 'Initials': 'A', 'LastName': 'Akyempon', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Millar', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Costeloe', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}]",Pediatric research,['10.1038/s41390-020-01135-5']
2811,32947839,Impact of Anticholinergic Medication Burden on Mobility and Falls in the Lifestyle Interventions for Elders (LIFE) Study.,"Anticholinergic cognitive burden (ACB) may be associated with detrimental effects on mobility and physical independence in older adults. We evaluated the incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls among participants within the Lifestyle Interventions for Elders (LIFE) trial according to varied anticholinergic burden levels. Participants aged 70-89 years were randomized to a physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication use as a summed score of a previously developed ACB scale. Confounders included demographic characteristics, physical function, cognitive function, and fall history. Average participant follow-up was 2.6 years and included outcome assessment for MMD, PMMD, and injurious falls every six months. Adjusted proportional hazards models evaluated the independent effects of ACB scores as well as interaction effects with the intervention. Of the 1635 participants, 986 (60%) used ≥1 anticholinergic medication. Compared to those with no burden, participants with an ACB score of 1 demonstrated increased MMD (HR = 1.42 [1.13-1.78]), PMMD (HR = 1.53 [1.12-2.09]), and injurious falls (HR = 1.60 [1.10-2.32]). Results similar in magnitude were observed for all other ACB levels versus the no burden group. Stepwise dose-response comparisons between ACB groupings did not demonstrate significant differences in outcomes. Stratification by PA or SA interventions demonstrated few differences from the combined overall trial results. Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls. Total anticholinergic burden was not associated with a stepwise dose-response relationship in mobility disability and may lack sensitivity to capture varied responses.",2020,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","['older adults', 'Elders (LIFE) Study', 'Participants aged 70-89 years', '1635 participants, 986 (60%) used ≥1 anticholinergic medication']","['physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication', 'Anticholinergic cognitive burden (ACB']","['ACB levels', 'incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls', 'demographic characteristics, physical function, cognitive function, and fall history', 'mobility and physical independence', 'MMD, PMMD, and injurious falls every six months', 'injurious falls', 'risk of MMD, PMMD, and injurious falls', 'Mobility and Falls', 'PMMD', 'MMD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1635.0,0.0385836,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Squires', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Vouri', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092989']
2812,32947959,Unimanual Intensive Therapy with or without Unaffected Hand Containment in Children with Hemiplegia. A Randomized Controlled Pilot Study.,"Children with hemiplegia have lower spontaneous use and quality of movement in the affected upper limb. The modified constraint-induced movement therapy (mCIMT) is applied to improve the affected upper limb function. The objective of this study was to study the efficacy of unaffected hand containment to obtain changes in the function of the affected upper limb after applying two unimanual therapies. A randomized controlled pilot study was performed with 16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55). mCIMT and unimanual therapy without containment (UTWC) were applied, with a total of 50 h distributed in five weeks (two h/per day). Two assessments were performed (pre- and post-treatment) to evaluate the affected upper limb spontaneous use, measured with the Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale). The progression of the variables was different in both groups. The results are expressed in the median of the improvement percent and interquartile range (IQR). The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group. The quality of movement increased in the mCIMT and UTWC groups, 24.21 (IQR: 13.44, 50.39), 1.34 (IQR: 0.00, 4.75), respectively and the greatest increase was obtained in the grasp variable for both groups. The use of unaffected hand containment in mCIMT would produce improvements in the affected upper limb functionality in children with hemiplegia (4-8 years old) compared to the same protocol without containment (UTWC).",2020,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","['Children with Hemiplegia', 'Children with hemiplegia', 'children with hemiplegia (4-8 years old', '16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55']","['modified constraint-induced movement therapy (mCIMT', 'mCIMT and unimanual therapy without containment (UTWC']","['interquartile range (IQR', 'quality of movement', 'Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0392550', 'cui_str': 'Infantile hemiplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0524540', 'cui_str': 'Shiner'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",16.0,0.0368662,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 49001 Seville, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ando-LaFuente', 'Affiliation': 'Physiotherapy Research Group in Toledo, GIFTO, 45071 Toledo, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ferri-Morales', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bravo-Esteban', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9092992']
2813,32971161,"Treatment of women's sexual dysfunction using Apium graveolens L. Fruit (celery seed): A double-blind, randomized, placebo-controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed), which could be used to improve sexual function among women. Since that time, local herbal shops in Iran continue to provide this herb as a natural aphrodisiac product.
AIM OF THE STUDY


This study aimed to evaluate the efficacy and safety of celery seed for the treatment of female sexual dysfunction.
METHODS AND MATERIALS


In this parallel, randomized, double-blinded clinical trial, 80 women were assigned to receive either 500 mg of celery seed or placebo 3 times a day for a period of 6 weeks (n = 40 per group). The female sexual function index (FSFI) questionnaire was used to evaluate women's sexual function before and after treatment.
RESULTS


At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P < 0.001). Increased total FSFI score is mainly contributed by improvement in the sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), and pain (p = 0.033) domains at the endpoint of study. No serious side effects were noticed in both groups during the study period.
CONCLUSION


It seems that celery seed improved sexual function in women and could be used as a safe, well-tolerated, and effective herbal medicine in women with sexual dysfunction.",2021,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","['female sexual dysfunction', ""women's sexual dysfunction using Apium graveolens L. Fruit (celery seed"", 'women with sexual dysfunction', 'Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed', '80 women']","['placebo', '500 mg of celery seed or placebo', 'Placebo']","['serious side effects', 'total FSFI score', 'efficacy and safety', 'arousal', 'female sexual function index (FSFI) questionnaire', 'sexual function', 'sexual desire', 'lubrication', 'pain']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0996918', 'cui_str': 'Apium'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.412374,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rahnavard', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center of Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Massoumeh', 'Initials': 'M', 'LastName': 'Emamghoreishi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hessami', 'Affiliation': 'School of Pharmacy, International Branch, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: anna_hessami@yahoo.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Maasumeh Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113400']
2814,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY


To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS


This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS


An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).
CONCLUSION


The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2021,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
2815,32971764,"Effects of Chewing Exerciser on the Recovery of Masticatory Function Recovery after Orthognathic Surgery: A Single-Center Randomized Clinical Trial, a Preliminary Study.","Background and Objectives : The aim of this study was to evaluate the effects of the chewing exerciser (CE) on the functional recovery of the masticatory muscles after orthognathic surgery.  Material and Methods:  This randomized clinical trial was conducted in patients undergoing bimaxillary orthognathic surgery including bilateral sagittal split ramus osteotomy. Postoperative physiotherapy (PT) was performed for 3 weeks starting 3 weeks after the surgery. The patients were randomly divided into two groups: control (Con) (conventional PT) group and CE group (use of CE in addition to conventional PT). The masticatory function was evaluated based on three standards: bite force (BF), amount of mouth opening (MO), and surface electromyography (sEMG) of the anterior temporal muscle (TA), masseter muscle (MM), sternocleidomastoid muscle, and anterior belly of digastric muscle before, 3 weeks (before PT) and 6 weeks after the surgery (after PT).  Results:  Finally, 22 subjects participated in this study: 10 patients for Con group and 12 patients for CE group. In both groups, the BF, which was reduced significantly after the surgery, recovered after the PT similar to that before the surgery. In both groups, the MO was also significantly reduced by the surgery. However, it did not recover as much, as it was before the surgery after applying the PT. There was no difference in BF and MO between the two groups. All muscles did not show significant changes in sEMG by surgery and PT at both resting and clenching states.  Conclusion:  Applying CE as a PT after orthognathic surgery did not cause any harmful side effects. In both groups, the weakened muscle activity after orthognathic surgery (OGS) was adequately restored 6 weeks after the surgery. However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.",2020,"However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.","['patients undergoing', '22 subjects participated in this study: 10 patients for Con group and 12 patients for CE group', 'after Orthognathic Surgery']","['chewing exerciser (CE', 'control (Con) (conventional PT) group and CE group (use of CE in addition to conventional PT', 'Postoperative physiotherapy (PT', 'bimaxillary orthognathic surgery including bilateral sagittal split ramus osteotomy', 'CE', 'Chewing Exerciser']","['bite force (BF), amount of mouth opening (MO), and surface electromyography (sEMG) of the anterior temporal muscle (TA), masseter muscle (MM), sternocleidomastoid muscle, and anterior belly of digastric muscle', 'sEMG', 'masticatory function', 'weakened muscle activity', 'BF and MO', 'Masticatory Function Recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0224156', 'cui_str': 'Structure of anterior belly of digastric muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",22.0,0.0340369,"However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.","[{'ForeName': 'Hoon Joo', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Ik Jae', 'Initials': 'IJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Akram Abdo', 'Initials': 'AA', 'LastName': 'Almansoori', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Yoojung', 'Initials': 'Y', 'LastName': 'Son', 'Affiliation': 'Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Bongju', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Soung-Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56090483']
2816,32971921,Motor Control Stabilisation Exercise for Patients with Non-Specific Low Back Pain: A Prospective Meta-Analysis with Multilevel Meta-Regressions on Intervention Effects.,"Low-to-moderate quality meta-analytic evidence shows that motor control stabilisation exercise (MCE) is an effective treatment of non-specific low back pain. A possible approach to overcome the weaknesses of traditional meta-analyses would be that of a prospective meta-analyses. The aim of the present analysis was to generate high-quality evidence to support the view that motor control stabilisation exercises (MCE) lead to a reduction in pain intensity and disability in non-specific low back pain patients when compared to a control group. In this prospective meta-analysis and sensitivity multilevel meta-regression within the MiSpEx-Network, 18 randomized controlled study arms were included. Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention). From each study site/arm, outcomes at baseline, 3 weeks, 12 weeks, and 6 months were pooled. The outcomes were current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability. A random effects meta-analysis model for continuous outcomes to display standardized mean differences between intervention and control was performed, followed by sensitivity multilevel meta-regressions. Overall, 2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses. In the short-term, intermediate and sustainability, moderate-to-high quality evidence indicated that MCE has a larger effect on current pain (SMD = -0.15, -0.15, -0.19), pain intensity (SMD = -0.19, -0.26, -0.26) and disability (SMD = -0.15, -0.27, -0.25) compared with no exercise intervention. Low-quality evidence suggested that those patients with comparably intermediate current pain and older patients may profit the most from MCE. Motor control stabilisation exercise is an effective treatment for non-specific low back pain. Sub-clinical intermediate pain and middle-aged patients may profit the most from this intervention.",2020,"Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention).","['2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses', 'Patients with Non-Specific Low Back Pain', 'non-specific low back pain', 'Participants with non-specific low back pain', 'Sub-clinical intermediate pain and middle-aged patients', 'non-specific low back pain patients']","['Motor control stabilisation exercise', 'motor control stabilisation exercise (MCE', 'intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention', 'motor control stabilisation exercises (MCE', 'MCE', 'Motor Control Stabilisation Exercise']","['pain intensity', 'current pain', 'disability', 'pain intensity and disability', 'current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442796', 'cui_str': 'Additive'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",2391.0,0.0427174,"Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Engel', 'Affiliation': 'University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Adamantios', 'Initials': 'A', 'LastName': 'Arampatzis', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Beck', 'Affiliation': 'University Hospital Carl Gustav Carus at Technical University Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moreno Catalá', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brenner-Fliesser', 'Affiliation': 'Sociology of Physical Activity and Health, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Güthoff', 'Affiliation': 'Centre for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin, 12683 Berlin, Germany.'}, {'ForeName': 'Thore', 'Initials': 'T', 'LastName': 'Haag', 'Affiliation': 'Orthopädiezentrum Theresie, 80339 München, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hönning', 'Affiliation': 'Centre for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin, 12683 Berlin, Germany.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Pfeifer', 'Affiliation': 'Pain Management, Center of Orthopaedics and Trauma Surgery, Heidelberg University Hospital, 69118 Heidelberg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schiltenwolf', 'Affiliation': 'Pain Management, Center of Orthopaedics and Trauma Surgery, Heidelberg University Hospital, 69118 Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Orthopädiezentrum Theresie, 80339 München, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Trompeter', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Pia-Maria', 'Initials': 'PM', 'LastName': 'Wippert', 'Affiliation': 'Sociology of Physical Activity and Health, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': 'University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, 14469 Potsdam, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9093058']
2817,32973056,"Effectiveness of three-dimensional printed and virtual reality models in learning the morphology of craniovertebral junction deformities: a multicentre, randomised controlled study.","OBJECTIVES


To compare the effectiveness of three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models in clinical education regarding the morphology of craniovertebral junction (CVJ) deformities.
DESIGN


Prospective, multicentre, randomised controlled study.
SETTING


Three teaching hospitals in China.
PARTICIPANTS


One hundred and fifty-three participants in their first year of a 3-year medical residency programme.
INTERVENTIONS


All participants were randomised to one of the three groups to learn the morphology of CVJ deformities using 3DP, VR or NP models.
PRIMARY OUTCOME MEASURES


The objective outcomes were evaluated using three-level objective testing. In the first-level test, the participants were required to identify 15 anatomical landmarks on radiographs without CVJ deformities. In the second-level test, all participants were asked to identify the same 15 landmarks on radiographs showing classic CVJ deformities. In the third-level test, the participants were required to describe the key features of three classic cases of CVJ deformities depicted on radiographs. Each participant was also asked to answer four subjective questions to evaluate the importance and usefulness of the educational materials.
RESULTS


In the first-level test, the 3DP, VR and NP groups achieved similar correct rates. In the second-level test, the correct rate was higher in the 3DP group (82.1%±13.6%) than the VR and NP groups (76.9%±16.9% and 69.9%±20.0%, p=0.002). In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups. The subjective tests showed that the 3DP model method was considered the most valuable approach for learning CVJ deformities.
CONCLUSIONS


The objective and subjective results show that the 3DP model is more effective teaching instrument than the NP model for learning the pathomorphology of CVJ deformities. The VR model also showed great efficacy, second to 3DP model, in improving participants' understanding of CVJ deformities.",2020,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","['craniovertebral junction deformities', 'One hundred and fifty-three participants in their first year of a 3-year medical residency programme', 'Three teaching hospitals in China']","['CVJ deformities using 3DP, VR or NP models', 'three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models', 'three-dimensional printed and virtual reality models']","['CVJ deformities features', 'correct rate']","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035184', 'cui_str': 'Medical Residency'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",153.0,0.0288685,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Plastic Surgery Hospital and Institute, Shijingshan District, Beijing, China.'}, {'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Orthopedic Surgery, Shanghai Jiaotong University Affiliated Sixth People Hospital South Campus, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China tianye2019trail@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036853']
2818,32973057,Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.,"INTRODUCTION


Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.
METHODS AND ANALYSIS


This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.
ETHICS AND DISSEMINATION


This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000028726).",2020,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"['patients with heart failure and LBBB', 'heart failure patients with left bundle branch block (LBBB', 'heart failure patients with left bundle branch block', 'From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study', 'cardiac centre of Beijing Anzhen Hospital']","['left bundle branch area pacing versus biventricular pacing', 'Left bundle branch area pacing (LBBaP', 'LBBaP']","['LVEF', 'Efficacy and safety', 'NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C0006384', 'cui_str': 'Bundle branch block'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429097', 'cui_str': 'QRS complex feature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011008', 'cui_str': 'Date'}]",,0.205921,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"[{'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Junmeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zefeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mengge', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, Beijing Anzhen Hospital, Capital Medical University, the Key Laboratory of Remodeling-Related Cardiovascular Diseases, Ministry of Education, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China wuyongquan67@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036972']
2819,32974746,Selection of a correct treatment protocol in caesarean scar pregnancies.,"OBJECTIVE


This study aims at assessing the effectiveness of various treatment protocols with the help of some parameters in caesarean scar pregnancies.
METHODS


A total of 26 patients were assessed in the study. The patients were divided into 4 groups. Group 1 consisted of those who had a wedge resection (n = 7), group 2 those who had a suction curettage (n = 10), group 3 those who had a systemic methotrexate (MTX) (n = 5) and group 4 those who had a systemic + local MTX (n = 4). The ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays of the groups were compared.
RESULTS


The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay. There was no statistically significant difference between the groups with respect to ßHcg half-lives and haemoglobin values.
CONCLUSION


The results of our study showed that there were no significant differences between treatment outcomes when appropriate protocols were employed. Therefore, the important point in CSPs is to assess correctly the type of CSP, the myometrial thickness and the patient's hemodynamic condition and select the most appropriate protocol accordingly rather than trying to establish a single standard treatment protocol.",2020,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"['A total of 26 patients were assessed in the study', 'caesarean scar pregnancies']","['suction curettage', 'wedge resection', 'systemic methotrexate (MTX) (n\u2009=\u20095) and group 4 those who had a systemic\u2009+\u2009local MTX']","['ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",26.0,0.0212301,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Altınboğa', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey. orhanaltinboga@gmail.com.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Yakıştıran', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Seyit Ahmet', 'Initials': 'SA', 'LastName': 'Erol', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Oğuz', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Bakırarar', 'Affiliation': 'Department of Statistics, Ankara University, Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Cavidan', 'Initials': 'C', 'LastName': 'Gülerman', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Şevki', 'Initials': 'Ş', 'LastName': 'Çelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Ali Turhan', 'Initials': 'AT', 'LastName': 'Çağlar', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05800-2']
2820,32943290,In-Person Contacts and Their Relationship With Alcohol Consumption Among Young Adults With Hazardous Drinking During a Pandemic.,"PURPOSE


Social distancing strategies such as ""stay-at-home"" (SAH) orders can slow the transmission of contagious viruses like the SARS-CoV-2 virus, but require population adherence to be effective. This study explored adherence to SAH orders by young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence.
METHODS


Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n = 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA. Participants provided experience sampling reports on drinking twice per week from the week before SAH orders started on April 1, 2020 through 6 weeks during the SAH period. We examined how in-person contact with non-household friends changed over time and event-level relationships between alcohol consumption and in-person contacts.
RESULTS


The percentage of participants with any in-person contact in the week before SAH was 44% (95% confidence interval [CI] 30%-59%), which decreased to 29% (95% CI 15%-43%) in the first SAH week and increased to 65% (95% CI 46%-85%) by SAH week 6. Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
CONCLUSIONS


Preliminary data indicate that, among young adults with hazardous drinking, adherence to public policies like SAH orders is suboptimal, declines over time, and is associated with drinking events. Interventions aimed at enhancing young adults' adherence to social distancing policies are urgently needed.",2020,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","['young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence', 'Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n\xa0= 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA', 'Young Adults With Hazardous Drinking During a Pandemic', 'young adults with hazardous drinking']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],[],,0.0502342,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Palo Alto, California. Electronic address: suffbp@stanford.edu.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Ram', 'Affiliation': 'Department of Psychology and Department of Communication, Stanford University, Palo Alto, California.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Robert Wood Johnson School of Medicine, Rutgers University, Brunswick, New Jersey.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.08.007']
2821,32941336,Comparison of Pneumatonometry and Transpalpebral Tonometry Measurements of Intraocular Pressure during Scleral Lens Wear.,"SIGNIFICANCE


As scleral lens wear becomes more common, understanding the impact of these lenses upon ocular physiology is critically important. Studies on the effect of scleral lens wear upon intraocular pressure (IOP) have used different instruments and have reported conflicting results.
PURPOSE


The purpose of this study was to compare assessment of IOP during scleral lens wear using pneumatonometry and transpalpebral tonometry.
METHODS


Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order. IOP was assessed with pneumatonometry and transpalpebral tonometry on both eyes before lens application, immediately after lens application, after 1 hour of lens wear, and immediately after lens removal. Paired t test compared mean IOP in the study eye to the control eye. Repeated-measures ANOVA was performed to take instrumentation, lens diameter, and their interaction into account in an analysis of the change in IOP in the study eye.
RESULTS


Mean peripheral IOP measured with pneumatonometry was not significantly different from baseline at any subsequent measurement. Measurements with transpalpebral tonometry, however, were significantly different during scleral lens wear immediately after application and after 1 hour of wear with both diameter lenses (P < .005), but were not significantly different after either sized lens was removed. Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
CONCLUSIONS


Assessment of IOP during scleral lens wear varies based upon the instrument that is used. Although further studies are clearly needed to further elucidate this issue, clinicians should continue to monitor optic nerve structure and function in scleral lens wearers, as they do in all patients.",2020,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","['Intraocular Pressure during Scleral Lens Wear', 'Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order']","['scleral lens wear upon intraocular pressure (IOP', 'Pneumatonometry and Transpalpebral Tonometry Measurements', 'pneumatonometry and transpalpebral tonometry']","['Mean peripheral IOP', 'IOP', 'IOP changes']","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.042258,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","[{'ForeName': 'Jennifer Swingle', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Cherie B', 'Initials': 'CB', 'LastName': 'Nau', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Schornack', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Shorter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nau', 'Affiliation': 'Korb & Associates, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Harthan', 'Affiliation': 'Illinois College of Optometry, Chicago, Illinois.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001574']
2822,32948554,Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.,"INTRODUCTION


Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
METHODS AND ANALYSIS


The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2  test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.
ETHICS AND DISSEMINATION


The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03787732.",2020,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","['13 academic intensive care units in the USA', 'patients receiving positive pressure ventilation during tracheal intubation', '1065 critically ill adults undergoing tracheal intubation with planned use of', 'critically ill adults']","['intravenous fluid bolus', 'fluid REsuscitation', 'positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus', 'fluid REsuscitation during Induction and Intubation']","['cardiovascular collapse', '28-day in-hospital mortality', 'cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",1065.0,0.64588,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036671']
2823,32948579,"Correction: Efficacy of  Bifidobacterium animalis  subsp. lactis (BB-12), B.  infantis  and  Lactobacillus acidophilus  (La-5) probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study Protocol.",,2020,,['preterm infants of 28+0-32+6 weeks of gestation'],"['placebo', 'Bifidobacterium animalis  subsp']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",[],,0.392847,,[],BMJ open,['10.1136/bmjopen-2019-032617corr1']
2824,32948800,Effect of acute physical exercise on motor sequence memory.,"Acute physical exercise improves memory functions by increasing neural plasticity in the hippocampus. In animals, a single session of physical exercise has been shown to boost anandamide (AEA), an endocannabinoid known to promote hippocampal plasticity. Hippocampal neuronal networks encode episodic memory representations, including the temporal organization of elements, and can thus benefit motor sequence learning. While previous work established that acute physical exercise has positive effects on declarative memory linked to hippocampal plasticity mechanisms, its influence on memory for motor sequences, and especially on neural mechanisms underlying possible effects, has been less investigated. Here we studied the impact of acute physical exercise on motor sequence learning, and its underlying neurophysiological mechanisms in humans, using a cross-over randomized within-subjects design. We measured behavior, fMRI activity, and circulating AEA levels in fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest. We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise. This enhancement correlated with AEA increase, and dovetailed with local increases in caudate nucleus and hippocampus activity. These findings demonstrate that acute physical exercise promotes sequence learning, thus attesting the overarching benefit of exercise to hippocampus-related memory functions.",2020,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.",['fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest'],"['acute physical exercise', 'physical exercise', 'Acute physical exercise']","['motor sequence memory', 'behavior, fMRI activity, and circulating AEA levels', 'caudate nucleus and hippocampus activity', 'memory functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",15.0,0.0360965,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Marin Bosch', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland. blanca.marinbosch@unige.ch.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Bringard', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Logrieco', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lauer', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Imobersteg', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferretti', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Igloi', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-72108-1']
2825,32947994,A Pilot Evaluation of a Smartphone Application for Workplace Depression.,"Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t 61  = 6.35;  p  < 0.001) and anxiety symptoms (t 60  = 7.35;  p  < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%,  p =  0.012). Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.",2020,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","['Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure', 'stressed working population', 'participants recruited via social media advertisements', 'Workplace Depression', 'workplace mental ill-health']",['Smartphone Application'],"['wellbeing', 'usability, feasibility, acceptability', 'anxiety symptoms', 'change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance', 'satisfactory levels of app usability, feasibility, and acceptability', 'work performance, absenteeism or exercise', 'depressive symptoms', 'new onset depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",81.0,0.281056,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","[{'ForeName': 'Daniel A J', 'Initials': 'DAJ', 'LastName': 'Collins', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Lavender', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, University of Sydney,Sydney, NSW 2050, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186753']
2826,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n  = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
2827,32950113,Effects of training on knowledge and attitudes of coronary care unit nurses in relation to teamwork: A quasi-experimental study.,"Teamwork has special significance in patient safety and quality of care in the coronary care units (CCUs). This study aimed to determine the impact of training on attitudes and knowledge of CCU nurses about teamwork. This quasi-experimental study was conducted in the CCUs of Al-Zahra Cardiovascular Hospital, Shiraz, Iran. Participants included 70 nurses with a mean age of 31.33 ± 4.56 years. They were divided into experimental and control groups. Data were collected at the baseline and one month after an intervention using a teamwork knowledge test and Teamwork Attitude Questionnaire. The intervention involved a 4-hour workshop on teamwork. Data were analyzed via SPSS 16.0, using descriptive statistics, chi-square, paired t-test, and independent samples t-test. The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001). Furthermore, the mean scores of attitude dimensions improved significantly, except for mutual support and situation monitoring. In addition, in relation to teamwork knowledge, the experimental group had a significantly higher mean score after the intervention (18.6 ± 4.35) compared with the baseline (13.14 ± 4.25) and the control group (14.8 ± 4.07) (P < .001). Training improved knowledge and attitudes of CCU nurses in relation to teamwork. Considering the critical role of mutual support and situation monitoring in nursing performance, we should place more emphasis on them in nursing education and practice. TRIAL REGISTRATION: IRCT2016080123199N2. Date registered 2016-09-22.",2020,The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001).,"['coronary care unit nurses in relation to teamwork', 'Participants included 70 nurses with a mean age of 31.33\xa0±\xa04.56 years']",[],"['teamwork knowledge test and Teamwork Attitude Questionnaire', 'mean scores of attitude dimensions', 'mean overall teamwork attitude score', 'mean score', 'knowledge and attitudes', 'knowledge and attitudes of CCU nurses']","[{'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",70.0,0.0174262,The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khademian', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nejatali', 'Initials': 'N', 'LastName': 'Mohebi', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Khademian', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: khademianm@sums.ac.ir.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.05.004']
2828,32955832,Acute high-intensity interval training improves motor skill acquisition.,"BACKGROUND


It is well established that acute exercise improves cognitive function. However, less is known about the effects of exercise on motor skill acquisition. Therefore, this study investigated the effects of acute high-intensity interval training (HIIT) on motor skill acquisition.
METHODS


Sixty individuals (27 males, 33 females) between 18 and 40 years of age participated in two testing sessions separated by one week. During visit 1, participants performed one block of a continuous tracking, force control task to establish baseline ability. Participants were then randomized to either an aerobic-only HIIT group (HIIT-A), an aerobic/resistance HIIT group (HIIT-AR), or a resting control group. Both exercise groups performed a 20-minute, digital versatile disc (DVD)-delivered HIIT exercise protocol during visit 2. Following exercise or rest, all participants performed five blocks of the same force control task to assess skill acquisition.
RESULTS


On visit 2, the HIIT-A group had a significantly lower total performance error (E) compared to the control group (P<0.05). Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05). No significant group differences were observed for temporal error (TE). Additionally, no significant differences were observed between the exercise groups (P>0.05).
CONCLUSIONS


These findings suggest that acute HIIT-A improves motor skill acquisition compared to rest. Furthermore, improvements in acquisition appeared to be a result of improved spatial accuracy. Therefore, performing HIIT-A prior to practicing a motor task may help reduce total error during the motor skill acquisition phase.",2020,Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05).,"['Sixty individuals (27 males, 33 females) between 18 and 40 years of age participated in two testing sessions separated by one week']","['digital versatile disc (DVD)-delivered HIIT exercise protocol', 'aerobic-only HIIT group (HIIT-A), an aerobic/resistance HIIT group (HIIT-AR), or a resting control group', 'acute high-intensity interval training (HIIT']","['motor skill acquisition', 'temporal error (TE', 'cognitive function', 'total performance error (E', 'peak amplitude error (PE']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",60.0,0.0371916,Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05).,"[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Kendall', 'Affiliation': 'Department of Kinesiology, Taylor University, Upland, CA, USA - brad_kendall@taylor.edu.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Siekirk', 'Affiliation': 'Division of Kinesiology, Health and Sport Studies, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lai', 'Affiliation': 'Division of Kinesiology, Health and Sport Studies, Wayne State University, Detroit, MI, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10580-2']
2829,32955839,Effects of pelvic and core strength training on biomechanical risk factors for anterior cruciate ligament injuries.,"BACKGROUND


Little is known about the changes in biomechanical risk factors for an anterior cruciate ligament (ACL) injury after participation in a pelvic and core strength training (PCST) program in female team players.
METHODS


This is a randomized controlled trial for which a total of 29 female soccer players were recruited from a soccer club and split into two groups, namely, experimental group (EG, N.=18; mean [SD] age, 17.8 [2.0 years], weight 64.0 [6.6] kg and height 1.7 [0.0] m) and control group (control, N.=11; mean [SD] age, 16.2 [1.2] years, weight 61.6 [7.3] kg and height 1.7 [0.0] m). The EG participated in an in-season 8-week PCST program (twice/week). Participants in the CG performed their normal training without additional pelvic and core strengthening. Pre- and postintervention knee frontal plane projection angle (FPPA), hip, knee and ankle peak flexion angles and jump height were collected during bilateral and unilateral drop jumps.
RESULTS


PCST significantly reduced FPPA at dynamic landing, in both dominant (-7.1º) and non-dominant lower extremities (-8º). Further, this training significantly increased the peak hip (24.4º) and knee flexion angles (14.94º), but not the peak ankle dorsiflexion angle (P>0.05) which, significantly decreased in the CG (-3.5º). Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
CONCLUSIONS


PCST resulted in improvements on ACL injury risk factors and vertical drop jump performance, suggesting that strengthening this body part warrants not only injury prevention, but increases jumping performance.",2020,"Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
","['anterior cruciate ligament injuries', '29 female soccer players were recruited from a soccer club and split into two groups, namely, experimental group (EG, N.=18; mean [SD] age, 17.8 [2.0 years], weight 64.0 [6.6] kg and height 1.7 [0.0] m) and control group (control, N.=11; mean [SD] age, 16.2 [1.2] years, weight 61.6 [7.3] kg and height 1.7 [0.0] m', 'anterior cruciate ligament (ACL) injury after participation in a pelvic and', 'female team players']","['PCST', 'normal training without additional pelvic and core strengthening', 'pelvic and core strength training', 'core strength training (PCST) program']","['FPPA at dynamic landing', 'peak hip (24.4º) and knee flexion angles', 'peak ankle dorsiflexion angle', 'ACL injury risk factors and vertical drop jump performance', 'biomechanical risk factors', 'unilateral jumps', 'Pre- and postintervention knee frontal plane projection angle (FPPA), hip, knee and ankle peak flexion angles and jump height']","[{'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",29.0,0.014644,"Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferri-Caruana', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Science of Physical Activity and Sport, University of Valencia, Valencia, Spain - ana.maria.ferri@uv.es.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Prades-Insa', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Science of Physical Activity and Sport, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-AÑÓ', 'Affiliation': 'UBIC Research Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10552-8']
2830,32955841,The effects of a 6-month moderate-intensity Hatha yoga-based training program on health-related fitness in middle-aged sedentary women: a randomized controlled study.,"BACKGROUND


There is paucity of data examining the effectiveness of long-term Hatha yoga-based (HY) programs focused on the health-related fitness (H-RF) of asymptomatic, sedentary women. The purpose of this study was to examine the effects of a 6-month HY-based training program on H-RF components in sedentary middle-aged women.
METHODS


Eighty sedentary women were randomly assigned into either the HY group (HYG) (N.=42) or the control group (CG) (N.=38). The 6-month HYG program involved a progressive series of Vinyasa Flow poses performed 3 times/week for 60 minutes (40 minutes within the exercise zone of 60-75% HR<inf>max</inf>). The CG participants did not undergo any physical training or education. Health-related fitness parameters included measures of pre- and post-training: body composition, muscular strength and maximal voluntary isometric torques of elbow flexors and knee extensors, cardio-respiratory fitness, lower back and hamstring flexibility and a static-dynamic balance.
RESULTS


Two-way mixed design ANOVA revealed significant main effects for all the indicators of H-RF. Tukey post-hoc tests confirmed that the HYG demonstrated significant improvements in every variable tested. Examples of the benefits achieved include (all P<.001): an average loss of 1.03 kg and a 4.82% decrease in body fat, 14.6% and 13.1% gains in isometric strength of the knee extensors and elbow flexors respectively, an increase in relative VO<inf>2max</inf> of 6.1% (33.12±5.30 to 35.14±4.82 mL/kg/min), a 4-cm or 10.4% increase in their MSAR, and an average improved Balance Index of 5.6 mm/s. Reversely, the CG showed non-significant changes in H-RF variables (all P>0.05; percent range from -1.4% to 1.1%).
CONCLUSIONS


By participating in a moderate-intensity 6-month HY-based training program, middle-aged women can significantly improve their HR-F status. The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.",2020,The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.,"['middle-aged sedentary women', 'sedentary middle-aged women', 'Eighty sedentary women', 'By participating in a moderate-intensity 6-month HY-based training program, middle-aged women']","['moderate-intensity Hatha yoga-based training program', '6-month HY-based training program', 'control group (CG']","['cardio-respiratory fitness and improvements in body composition', 'HR-F status', 'Balance Index', 'body fat', 'composition, muscular strength and maximal voluntary isometric torques of elbow flexors and knee extensors, cardio-respiratory fitness, lower back and hamstring flexibility and a static-dynamic balance', 'isometric strength of the knee extensors and elbow flexors', 'health-related fitness', 'H-RF variables']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0230102', 'cui_str': 'Lower back structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",80.0,0.0265605,The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.,"[{'ForeName': 'Michał T', 'Initials': 'MT', 'LastName': 'Boraczyński', 'Affiliation': 'Department of Health Sciences, Olsztyn University, Olsztyn, Poland - michal.boraczynski@gmail.com.'}, {'ForeName': 'Tomasz W', 'Initials': 'TW', 'LastName': 'Boraczyński', 'Affiliation': 'Department of Health Sciences, Olsztyn University, Olsztyn, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Wójcik', 'Affiliation': 'Department of Environmental Sciences, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gajewski', 'Affiliation': 'Department of Physical Education, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy and Rehabilitation Sciences, University of Montana, Missoula, MT, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10549-8']
2831,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES


Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS


Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS


One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS


There was no clinical control group.
CONCLUSIONS


These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2020,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
2832,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2833,32958377,Effect of motor imagery on enjoyment in knee-injury prevention and rehabilitation training: A randomized crossover study.,"OBJECTIVES


The novel MOTor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) model takes a uniquely holistic approach by integrating mental and physical aspects into current training programs. The aim of this trial was to evaluate enjoyment of MOTIFS training as compared to Care-as-Usual (CaU) knee injury and/or rehabilitation training. The primary hypothesis was that enjoyment would be greater following MOTIFS training than CaU training.
DESIGN


Block-randomized 2×2 cross-over trial.
METHODS


Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump and/or directional changes. MOTIFS training integrates sport-specific experiences and equipment into physical exercises to increase individualized realism and meaning. The CaU condition included solely physical exercise. The main outcome was the Physical Activity Enjoyment Scale (PACES). Secondary outcomes included Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality.
RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3). Between-groups differences in SAM Valence (median 2, quartiles 1;3), Arousal (median 1, quartiles 0;2.25), and Dominance (median 0.5, quartiles 0;2), and RPE (median 1, quartiles -0.3;2), training duration (mean 5.34, 95% CI: -0.17; -0.73), and pulse (median 7.50, quartiles 0.25;16.75) were higher following MOTIFS training than CaU training.
CONCLUSIONS


Results suggest that the MOTIFS model, which integrates simultaneous physical and psychological interventions, is a clinically plausible method of influencing enjoyment and other psychological outcomes. Further studies may explore effects of the MOTIFS principles on injury prevention and rehabilitation training.",2020,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","['Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump']","['Care-as-Usual (CaU) knee injury and/or rehabilitation training', 'motor imagery', 'MOTIFS training']","['SAM Valence', 'training duration', 'Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality', 'Physical Activity Enjoyment Scale (PACES', 'RPE']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",30.0,0.0946022,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Cederström', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden. Electronic address: niklas.cederstrom@med.lu.se.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Granér', 'Affiliation': 'Department of Psychology, Lund University, Sweden.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Nilsson', 'Affiliation': 'Malmö Idrottsklinik, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ageberg', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.09.004']
2834,32960242,Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial.,"Importance


Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women.
Objective


To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women.
Design, Setting, and Participants


Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019.
Interventions


Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808).
Main Outcomes and Measures


The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions.
Results


Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, -0.53%; 95% CI, -1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, -0.27%; 95% CI, -2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001).
Conclusions and Relevance


Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery.
Trial Registration


ClinicalTrials.gov Identifier: NCT03009110.",2020,"Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70).","['obese women', 'Obese Women', 'obese women after cesarean delivery', '1624 of 2850 participants', 'Obese women undergoing planned or unplanned cesarean delivery were eligible', '1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group', 'February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States', 'obese women undergoing cesarean delivery', 'After Cesarean Delivery']","['Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing', 'standard wound dressing', 'prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n\u2009=\u2009816), or receive standard wound dressing', 'prophylactic negative pressure wound therapy']","['wound complications', 'wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions', 'Adverse skin reactions', 'Superficial or deep surgical-site infection', 'adverse events', 'risk of surgical-site infection', 'superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions', 'Surgical-Site Infection', 'composite of surgical-site infections and other wound complications']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",2850.0,0.233264,"Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70).","[{'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Obstetrics and Gynecology, Ochsner Health, New Orleans, Louisiana.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Trudell', 'Affiliation': 'Division of Maternal Fetal Medicine, BJC Medical Group St Louis, Missouri.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Carter', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shanks', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Warren', 'Affiliation': 'Department of Medicine, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Odibo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of South Florida School of Medicine, Tampa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell School of Medicine, University of Texas at Austin.'}, {'ForeName': 'Lorie', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham.'}]",JAMA,['10.1001/jama.2020.13361']
2835,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS


In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS


Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION


Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION


REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
2836,32955177,Osimertinib in Resected  EGFR -Mutated Non-Small-Cell Lung Cancer.,"BACKGROUND


Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor ( EGFR ) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.
METHODS


In this double-blind, phase 3 trial, we randomly assigned patients with completely resected  EGFR  mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety.
RESULTS


A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001). In the overall population, 89% of the patients in the osimertinib group (95% CI, 85 to 92) and 52% of those in the placebo group (95% CI, 46 to 58) were alive and disease-free at 24 months (overall hazard ratio for disease recurrence or death, 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). At 24 months, 98% of the patients in the osimertinib group (95% CI, 95 to 99) and 85% of those in the placebo group (95% CI, 80 to 89) were alive and did not have central nervous system disease (overall hazard ratio for disease recurrence or death, 0.18; 95% CI, 0.10 to 0.33). Overall survival data were immature; 29 patients died (9 in the osimertinib group and 20 in the placebo group). No new safety concerns were noted.
CONCLUSIONS


In patients with stage IB to IIIA  EGFR  mutation-positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).",2020,"At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001).","['682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group', 'randomly assigned patients with completely resected  EGFR  mutation-positive NSCLC in a 1:1 ratio to receive either']","['placebo', 'osimertinib (80 mg once daily) or placebo']","['efficacy and safety', 'alive and disease-free (overall hazard ratio for disease recurrence or death', 'disease-free survival', 'alive and disease-free', 'central nervous system disease', 'Overall survival data', 'overall survival, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",682.0,0.762947,"At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001).","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grohe', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Laktionov', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Huu-Vinh', 'Initials': 'HV', 'LastName': 'Vu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Kye-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hodge', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Ajlan', 'Initials': 'A', 'LastName': 'Atasoy', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2027071']
2837,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND


In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION


The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS


Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS


The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE


The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
2838,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
2839,32957604,Impact of Three-Year Intermittent Preventive Treatment Using Artemisinin-Based Combination Therapies on Malaria Morbidity in Malian Schoolchildren.,"Previous studies have shown that a single season of intermittent preventive treatment in schoolchildren (IPTsc) targeting the transmission season has reduced the rates of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia. Efficacy over the course of multiple years of IPTsc has been scantly investigated.
METHODS


An open, randomized-controlled trial among schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali. Students were included in three arms: sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C). All students received two full doses, given 2 months apart, and were compared with respect to the incidence of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia.
RESULTS


A total of 296 students were randomized. All-cause clinic visits were in the SP+AS versus control (29 (20.1%) vs. 68 (47.2%); 20 (21.7%) vs. 41 (44.6%); and 14 (21.2%) vs. 30 (44.6%);  p  < 0.02) in 2007, 2008, and 2009, respectively. The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively. Hemoglobin concentration was significantly higher in children receiving SP+AS (11.96, 12.06, and 12.62 g/dL) than in control children (11.60, 11.64, and 12.15 g/dL;  p  < 0.001) in 2007, 2008, and 2009, respectively. No impact on clinical malaria was observed.
CONCLUSION


IPTsc with SP+AS reduced the rates of all-cause clinic visits and anemia during a three-year implementation.",2020,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","['schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali', 'A total of 296 students', 'Malian Schoolchildren']","['sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C', 'Artemisinin-Based Combination Therapies']","['All-cause clinic visits', 'rates of all-cause clinic visits and anemia', 'Malaria Morbidity', 'Efficacy', 'prevalence of asymptomatic parasitemia', 'Hemoglobin concentration', 'clinical malaria']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038679', 'cui_str': 'Sulfadoxine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}]",296.0,0.0715299,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","[{'ForeName': 'Hamma', 'Initials': 'H', 'LastName': 'Maiga', 'Affiliation': 'Institut National de Santé Publique, Bamako 1771, Mali.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Barger', 'Affiliation': 'Spokane Emergency Physicians, Spokane, WA 99201, USA.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Oumar B', 'Initials': 'OB', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Tekete', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Zoumana I', 'Initials': 'ZI', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Kodio', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ousmane B', 'Initials': 'OB', 'LastName': 'Toure', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ogobara K', 'Initials': 'OK', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye A', 'Initials': 'AA', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}]",Tropical medicine and infectious disease,['10.3390/tropicalmed5030148']
2840,32957612,"Effect of Daily Intake of Green Tea Catechins on Cognitive Function in Middle-Aged and Older Subjects: A Randomized, Placebo-Controlled Study.","Epidemiological studies in Japan, including the Nakajima study and the Tsurugaya study, have indicated that green tea consumption may improve cognitive impairment. Catechins, which are typical polyphenols contained in green tea, have been reported to have antioxidative, anti-inflammatory, and neuroprotective effects. However, their impact on human cognitive function remains unclear. Therefore, we performed a double-blind, randomized, controlled study to investigate the effect of 336.4 mg of decaffeinated green tea catechins (GTC) on cognitive function after a single dose and after 12 weeks of daily intake. This study included Japanese adults between the ages of 50 and 69 years with a Mini-Mental State Examination Japanese version score of >24 and self-assessed cognitive decline. The Cognitrax testing battery was used to evaluate cognitive function. The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC. After 12 weeks of daily GTC intake, the response time for Part 4 of the 4-part Continuous Performance Test, which is a two-back test, was shortened. These results suggest that daily intake of GTC might have beneficial effects on working memory.",2020,The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC.,"['Japanese adults between the ages of 50 and 69 years with a Mini-Mental State Examination Japanese version score of >24 and self-assessed cognitive decline', 'Middle-Aged and Older Subjects']","['decaffeinated green tea catechins (GTC', 'GTC', 'Placebo', 'Green Tea Catechins']","['Cognitive Function', 'cognitive function', 'incorrect response rate', 'cognitive impairment', 'response time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.149687,The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC.,"[{'ForeName': 'Yoshitake', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Inagaki', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Ryobi Building F4 33-13 Mukojima 3-chome, Sumida-ku, Tokyo 131-0033, Japan.'}, {'ForeName': 'Makaoto', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Takihara', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25184265']
2841,32960669,Evaluation of a Tube Voltage-Tailored Contrast Medium Injection Protocol for Coronary CT Angiography: Results From the Prospective VOLCANIC Study.,"OBJECTIVE.  The purpose of this study was to prospectively evaluate, using software support, the feasibility and the quantitative and qualitative image quality parameters of a tube voltage-tailored contrast medium (CM) application protocol for patient-specific injection during coronary CT angiography (CCTA).  SUBJECTS AND METHODS.  In the Voltage-Based Contrast Media Adaptation in Coronary Computed Tomography Angiography (VOLCANIC-CTA) study, a single-center trial, 120 patients referred for CCTA were prospectively assigned to a tube voltage-tailored CM injection protocol. Automated tube voltage levels were selected in 10-kV intervals and ranged from 70 to 130 kV, and the iodine delivery rate (IDR) was adapted to the tube voltage level using dedicated software. The administered CM volume (370 mg I/mL) ranged from 33 mL at 70 kV (IDR, 0.7 g I/s) to 65 mL at 130 kV (IDR, 1.7 g I/s). Attenuation was measured in the aorta and coronary arteries to calculate quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales were used to evaluate overall image quality. Radiation metrics were also assessed and compared among the protocols.  RESULTS.  The mean age of the study patients was 62.5 ± 11.9 (SD) years. Image quality was rated as diagnostic in all patients. Contrast attenuation peaked at 70 kV ( p  < 0.001), whereas SNR and CNR parameters showed no significant differences between tube voltage levels ( p  ≥ 0.085). Additionally, no significant differences in subjective image quality parameters were found among the different protocols ( p  ≥ 0.139). The lowest radiation dose values were observed in the group assigned to the 70-kV protocol, which had a median radiation effective dose of 2.0 mSv ( p  < 0.001).  CONCLUSION.  The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.",2020,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"['The mean age of the study patients was 62.5 ± 11.9 (SD) years', 'Coronary CT Angiography', 'patient-specific injection during coronary CT angiography (CCTA', '120 patients referred for CCTA']","['tube voltage-tailored contrast medium (CM) application protocol', 'tube voltage-tailored CM injection protocol', 'Tube Voltage-Tailored Contrast Medium Injection Protocol']","['quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales', 'Radiation metrics', 'Image quality', 'subjective image quality parameters', 'lowest radiation dose values', 'tube voltage levels', 'iodine delivery rate (IDR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",120.0,0.0253303,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dante A', 'Initials': 'DA', 'LastName': 'Giovagnoli', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Abadia', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vingiani', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Philipp L von Knebel', 'Initials': 'PLVK', 'LastName': 'Doeberitz', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Hubert E', 'Initials': 'HE', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fischer', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Varga-Szemes', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carlo N', 'Initials': 'CN', 'LastName': 'De Cecco', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.22777']
2842,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2843,32963063,Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.,"INTRODUCTION


Through addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.
METHODS AND ANALYSIS


Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.
DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
ETHICS AND DISSEMINATION


The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.
TRAIL REGISTRATION NUMBER


This trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.",2020,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","['Australian primary care patients', 'Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey']",[],['uptake of LARC'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],,0.172989,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia Danielle.Mazza@monash.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Amos', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Watson', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Centre for Health Economics Research & Evaluation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics & Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Lucke', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McNamee', 'Affiliation': 'Family Planning Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Royal Prince Alfred Hospital, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035895']
2844,32963066,Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol.,"INTRODUCTION


Over 52 million children under 5 years of age become wasted each year, but only 17% of these children receive treatment. Novel methods to identify and deliver treatment to malnourished children are necessary to achieve the sustainable development goals target for child health. Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.
METHODS AND ANALYSIS


This randomised controlled trial will recruit 1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. Caregiver-infant dyads will be randomised to either a maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC). Study staff will train all caregivers to measure their child's mid-upper arm circumference (MUAC). Caregivers in the MAMMS arm will be given two colour coded and graduated insertion MUAC tapes and be enrolled in a mHealth system that sends weekly short message service (SMS) messages prompting caregivers to measure and report their child's MUAC by SMS. Caregivers in the SOC arm will receive routine monitoring by community health volunteers coupled with a quarterly visit from study staff to ensure adequate screening coverage. The primary outcome is identification of childhood malnutrition, defined as MUAC <12.5 cm, in the MAMMS arm compared with the SOC arm. Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age. Finally, we will explore the acceptability, fidelity and feasibility of implementing the MAMMS within existing nutrition programmes.
ETHICS AND DISSEMINATION


The study was approved by review boards at the University of Washington and the Kenya Medical Research Institute. A data and safety monitoring board has been convened, and the results of the trial will be published in peer-reviewed scientific journals, presented at appropriate conferences and to key stakeholders.
TRIAL REGISTRATION NUMBER


NCT03967015; Pre-results.",2020,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"['1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya', 'malnourished children', 'Kenya']","['MAMMS', 'maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC', 'two-way short message service (SMS', 'Mobile health (mHealth) programmes']","['accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition', 'identification of childhood malnutrition']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",1200.0,0.129427,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"[{'ForeName': 'Kirkby D', 'Initials': 'KD', 'LastName': 'Tickell', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA kirkbt@uw.edu.'}, {'ForeName': 'Mareme M', 'Initials': 'MM', 'LastName': 'Diakhate', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Goodman', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Rubin Means', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Choo', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Achieng', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Masheti', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Benson O', 'Initials': 'BO', 'LastName': 'Singa', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'McGrath', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036660']
2845,32966563,Immediate Biochemical Changes After Gait Biofeedback in Individuals With Anterior Cruciate Ligament Reconstruction.,"CONTEXT


Gait biomechanics are linked to biochemical changes that contribute to the development of posttraumatic knee osteoarthritis in individuals with anterior cruciate ligament reconstruction (ACLR). It remains unknown if modifying peak loading during gait using real-time biofeedback will result in acute biochemical changes related to cartilage metabolism.
OBJECTIVE


To determine if acutely manipulating peak vertical ground reaction force (vGRF) during gait influences acute changes in serum cartilage oligomeric matrix protein concentration (sCOMP) among individuals with ACLR.
DESIGN


Crossover study.
PATIENTS OR OTHER PARTICIPANTS


Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97). Additionally, we identified a subgroup of participants who demonstrated an increase in sCOMP after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32).
MAIN OUTCOME MEASURE(S)


Serum was collected both prior to and immediately after each condition to determine sCOMPchange.
INTERVENTION(S)


All participants attended 4 sessions that involved 20 minutes of walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF between limbs, (2) a 5% increase in vGRF (high loading) and (3) a 5% decrease in vGRF (low loading). A general linear mixed model was used to determine differences in sCOMPCHANGE between altered loading conditions and the control group in the entire cohort and the subgroup.
RESULTS


The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282). Within the subgroup, sCOMPCHANGE was less during high loading (1.95 ± 24.22 ng/mL, t21 = -3.53, P = .005) and symmetric loading (9.93 ± 21.45 ng/mL, t21 = -2.86, P = .025) compared with the control condition (25.79 ± 21.40 ng/mL).
CONCLUSIONS


Increasing peak vGRF during gait decreased sCOMP in individuals with ACLR who naturally demonstrated an increase in sCOMP after 20 minutes of walking.
TRIAL REGISTRY


ClinicalTrials.gov (NCT03035994).",2020,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","['Individuals With Anterior Cruciate Ligament Reconstruction', 'individuals with anterior cruciate ligament reconstruction (ACLR', 'Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97', 'individuals with ACLR', 'after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32']","['Gait Biofeedback', 'walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF']","['symmetric loading', 'sCOMP', 'Immediate Biochemical Changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0605497,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","[{'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Franz', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Davis-Wilson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}]",Journal of athletic training,['10.4085/1062-6050-0372.19']
2846,32966568,A Social-Marketing Intervention and Concussion-Reporting Beliefs.,"CONTEXT


Concussion-symptom education remains the primary approach used by athletic trainers to address underreporting of possible sport-related concussions. Social marketing represents an untapped approach to promote concussion reporting by communicating the benefits or consequences of reporting or not reporting, respectively.
OBJECTIVE


To apply expectancy value theory and identify how marketing the possible consequences of concealing concussion symptoms influenced young adults' concussion-reporting beliefs to increase the likelihood of reporting.
DESIGN


Randomized controlled clinical trial.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


A total of 468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk.
INTERVENTION(S)


Participants were randomly assigned by team to 1 of 3 conditions. The treatment condition was a social-marketing program focused on the possible consequences of the reporting decision. The control condition was traditional concussion-symptom education based on the National Collegiate Athletic Association's publication, ""Concussion: A Fact Sheet for Student-Athletes."" An additional condition mirrored the traditional symptom education but included a less clinical delivery.
MAIN OUTCOME MEASURE(S)


Positive and negative beliefs regarding concussion reporting were assessed. We applied expectancy value theory, which posits that changing beliefs in the short term will produce greater reporting intentions in the long term.
RESULTS


Club sport athletes exposed to consequence-based social marketing showed higher levels of positive reporting beliefs and lower levels of negative reporting beliefs than athletes exposed to traditional or revised symptom education. We observed no differences between the traditional and revised symptom-education programs. Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
CONCLUSIONS


Social marketing offers athletic trainers another strategic tool for motivating athletes to report concussion symptoms by translating scientific findings into marketable statements and then communicating the benefits of reporting or the negative consequences of concealing concussion symptoms.",2020,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","['Student-Athletes', '468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk']",['Concussion'],['positive reporting beliefs and lower levels of negative reporting beliefs'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",468.0,0.0262032,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","[{'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Warmath', 'Affiliation': 'Department of Financial Planning, Housing, and Consumer Economics, College of Family and Consumer Sciences, University of Georgia, Athens.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Winterstein', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Madison.'}]",Journal of athletic training,['10.4085/1062-6050-242-19']
2847,32967160,Non-Immersive Virtual Reality for Post-Stroke Upper Extremity Rehabilitation: A Small Cohort Randomized Trial.,"Immersive and non-immersive virtual reality (NIVR) technology can supplement and improve standard physiotherapy and neurorehabilitation in post-stroke patients. We aimed to use MIRA software to investigate the efficiency of specific NIVR therapy as a standalone intervention, versus standardized physiotherapy for upper extremity rehabilitation in patients post-stroke. Fifty-five inpatients were randomized to control groups (applying standard physiotherapy and dexterity exercises) and experimental groups (applying NIVR and dexterity exercises). The two groups were subdivided into subacute (<six months post-stroke) and chronic (>six months to four years post-stroke survival patients). The following standardized tests were applied at baseline and after two weeks post-therapy: Fugl-Meyer Assessment for Upper Extremity (FMUE), the Modified Rankin Scale (MRS), Functional Independence Measure (FIM), Active Range of Motion (AROM), Manual Muscle Testing (MMT), Modified Ashworth Scale (MAS), and Functional Reach Test (FRT). The Kruskal-Wallis test was used to determine if there were significant differences between the groups, followed with pairwise comparisons. The Wilcoxon Signed-Rank test was used to determine the significance of pre to post-therapy changes. The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences. Independent Kruskal-Wallis results showed that the subacute experimental group outcomes were statistically significant regarding the assessments, especially in comparison with the control groups. The results suggest that NIVR rehabilitation is efficient to be administered to post-stroke patients, and the study design can be used for a further trial, in the perspective that NIVR therapy can be more efficient than standard physiotherapy within the first six months post-stroke.",2020,"The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences.","['Post-Stroke Upper Extremity Rehabilitation', 'Fifty-five inpatients', 'post-stroke patients', 'patients post-stroke']","['NIVR rehabilitation', 'Immersive and non-immersive virtual reality (NIVR) technology', 'control groups (applying standard physiotherapy and dexterity exercises) and experimental groups (applying NIVR and dexterity exercises']","['Modified Rankin Scale (MRS), Functional Independence Measure (FIM), Active Range of Motion (AROM), Manual Muscle Testing (MMT), Modified Ashworth Scale (MAS), and Functional Reach Test (FRT', 'MMT, FMUE, and FIM assessments pre- and post-therapy']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",55.0,0.0314642,"The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences.","[{'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Miclaus', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Nadinne', 'Initials': 'N', 'LastName': 'Roman', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Silviu', 'Initials': 'S', 'LastName': 'Caloian', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Mitoiu', 'Affiliation': 'Rehabilitation Department, ""Carol Davila"" University of Medicine and Pharmacy, 0050474 Bucuresti, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Suciu', 'Affiliation': 'Department of Rehabilitation, Physical Medicine and Rheumatology, ""Victor Babeș"" University of Medicine and Pharmacy in Timisoara, 300041 Timisoara, Romania.'}, {'ForeName': 'Roxana Ramona', 'Initials': 'RR', 'LastName': 'Onofrei', 'Affiliation': 'Department of Rehabilitation, Physical Medicine and Rheumatology, ""Victor Babeș"" University of Medicine and Pharmacy in Timisoara, 300041 Timisoara, Romania.'}, {'ForeName': 'Ecaterina', 'Initials': 'E', 'LastName': 'Pavel', 'Affiliation': 'Faculty of Letters, Transilvania University of Brasov, 500030 Brasov, Romania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neculau', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}]",Brain sciences,['10.3390/brainsci10090655']
2848,32967873,Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands.,"INTRODUCTION


Delirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
METHODS AND ANALYSIS


EuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.
ETHICS AND DISSEMINATION


The study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.
TRIAL REGISTRATION


NCT03628391.",2020,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","['adult Critically ill patiEnts (EuRIDICE', 'adult critically ill patients to reduce days spent with coma or delirium', 'Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment']","['halopeRIdol', 'haloperidol 2.5\u2009mg (or matching placebo', 'placebo', 'haloperidol']","['burden of Delirium', 'DCFDs', 'efficacy and safety', 'delirium and coma-free days (DCFD', '1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.593027,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smit', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Trogrlić', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Northeastern University Bouve College of Health Sciences, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Osse', 'Affiliation': 'Department of Psychiatry, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Huibert H', 'Initials': 'HH', 'LastName': 'Ponssen', 'Affiliation': 'Department of Intensive Care, Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Centre Utrecht Brain Centre, Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Nicole G M', 'Initials': 'NGM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Pharmacy and Department of Intensive Care Adults, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Wim J R', 'Initials': 'WJR', 'LastName': 'Rietdijk', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Gommers', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'van der Jagt', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands m.vanderjagt@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036735']
2849,32967874,"Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial.","INTRODUCTION


Communication is an essential aspect of care for patients with progressive serious illnesses. This study aims to evaluate the efficacy of a new, integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers.
METHODS AND ANALYSIS


The proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospitals in a metropolitan area in Japan. A total of 20 oncologists, 200 patients with advanced pancreatic cancer and the patients' caregivers are enrolled in this study as of the writing of this protocol report. Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients and caregivers are allocated to the same group as their oncologists. The IG oncologists receive a 2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training. Follow-up data will be collected quarterly for 6 months for a year and then annually for up to 3 years. The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
ETHICS AND DISSEMINATION


This study is conducted in accordance with the ethical guidelines for clinical studies published by Japan's Ministry of Education, Cultural, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of National Cancer Center, Japan on 4 July 2018 (ID: 2017-474).
TRIAL STATUS


This study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trial Registry (UMIN000033612); pre-results.",2020,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","['patients with rapidly progressing advanced cancer and their caregivers', 'oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication', ""200 patients with advanced pancreatic cancer and the patients' caregivers"", 'comprehensive cancer centre hospitals in a metropolitan area in Japan', 'patients with progressive serious illnesses']","['2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training', 'integrated communication support program', 'Integrated communication support program', 'intervention group (IG) or control group (CG']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],200.0,0.0842864,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","[{'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan mfujimor@ncc.go.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Jinno', 'Affiliation': 'Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Chuo-ku, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine Department of Medical Biochemistry, Sendai, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary Pancreatic Oncology, National Cancer Center-Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ozaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Medical Oncology, Public Interest Incorporated Foundation Cancer Institute Hospital of JFCR, Koto-ku, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Takayama', 'Affiliation': ""Department of Medicine, Institute of Gastroenterology, Tokyo Women's Medical University Hospital, Shinjuku-ku, Japan.""}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Bunkyo-ku, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Majima', 'Affiliation': 'President, Pancreatic Cancer Action Network, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036745']
2850,32967877,Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking. Given the substantial impact of SDNS/FRNS on quality of life, strategies aiming to provide long-term remission while minimising treatment side effects are needed. Several studies confirm that rituximab is effective in preventing early relapses in SDNS/FRNS; however, the long-term relapse rate remains high (~70% at 2 years). This trial will assess the association of intravenous immunoglobulins (IVIgs) to rituximab in patients with SDNS/FRNS and inform clinicians on whether IVIg's immunomodulatory properties can alter the course of the disease and reduce the use of immunosuppressive drugs and their side effects.
METHODS AND ANALYSIS


We conduct an open-label multicentre, randomised, parallel group in a 1:1 ratio, controlled, superiority trial to assess the safety and efficacy of a single infusion of rituximab followed by IVIg compared with rituximab alone in childhood-onset FRNS/SDNS. The primary outcome is the occurrence of first relapse within 24 months. Patients are allocated to receive either rituximab alone (375 mg/m²) or rituximab followed by IVIg, which includes an initial Ig dose of 2 g/kg, followed by 1.5 g/kg injections once a month for the following 5 months (maximum dose: 100 g).
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee (Comité de Protection des Personnes) of Ouest I and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03560011.",2020,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","['patients with SDNS/FRNS', 'childhood-onset FRNS/SDNS', 'childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome']","['SDNS/FRNS', 'intravenous immunoglobulin with rituximab versus rituximab alone', 'rituximab', 'intravenous immunoglobulins (IVIgs) to rituximab', 'rituximab alone']","['Efficacy and safety', 'safety and efficacy', 'occurrence of first relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.194947,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France julien.hogan@aphp.fr.'}, {'ForeName': 'Aubriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Surgery, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Sellier-Leclerc', 'Affiliation': 'Department of Pediatric Nephrology, Hôpital Femme Mère Enfant, Bron, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vrillon', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Broux', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Rouen, Rouen, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Besancon, Besancon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Harambat', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Bordeaux Groupe hospitalier Pellegrin, Bordeaux, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Bessenay', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Audard', 'Affiliation': 'Department of Nephrology and Transplantation, Henri Mondor Hospital, APHP, Université Paris-Est, Créteil, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faudeux', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Morin', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pietrement', 'Affiliation': ""Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Reims Hôpital d'enfants, Reims, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tellier', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Eckart', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lahoche', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Lille, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roussey-Kesler', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ulinski', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Trousseau la Roche-Guyon, Paris, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Boyer', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Plaisier', 'Affiliation': 'Department of Nephrology, Hopital Tenon, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cloarec', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jolivot', 'Affiliation': 'Department of Nephrology, Groupement Hospitalier Edouard Herriot, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guigonis', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Limoges, Limoges, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guilmin-Crepon', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Baudouin', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dossier', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}]",BMJ open,['10.1136/bmjopen-2020-037306']
2851,32967883,Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol.,"INTRODUCTION


Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.
METHODS AND ANALYSIS


STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.
TRIAL REGISTRATION


The trial is registered on ClinicalTrials.gov (ID: NCT03548428).
ETHICS AND DISSEMINATION


This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.",2020,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","['et outre-mer 4 on 18 October 2019', 'oligometastatic sarcoma patients', 'oligometastatic soft tissue sarcomas']","['SBRT with atezolizumab and SBRT alone', 'immunomodulated stereotactic multisite irradiation', 'Cytotoxic therapy', 'SBRT', 'concomitant radiotherapy with atezolizumab', 'stereotactic body radiation therapy (SBRT']","['PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution', 'progression-free survival (PFS) rate']","[{'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0876936', 'cui_str': 'Mathematical Model'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",,0.112088,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'le Guevelou', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Debaigt', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Viotti', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Khalladi', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thibouw', 'Affiliation': 'Medical oncology department, Georges-Francois Leclerc Centre, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Medical oncology department, Centre Oscar Lambret, lille, France.'}, {'ForeName': 'Marie Pierre', 'Initials': 'MP', 'LastName': 'Sunyach', 'Affiliation': 'Centre Léon Bérard, Lyon, Rhône-Alpes, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': ""Paoli-Calmettes Institute, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Benchalal', 'Affiliation': 'Eugène Marquis Cancer Institute, Rennes, Bretagne, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Radiation oncology department, CHU Rouen Biochimie Médicale, Rouen, Haute-Normandie, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ducassou', 'Affiliation': 'Radiation oncology department, IUCT Oncopole, Toulouse, Languedoc-Roussillon-Midi, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'le Pechoux', 'Affiliation': 'Radiation oncology department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jolnerovski', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bazille', 'Affiliation': 'Biomolecular pathology department, CHU Caen, Caen, Basse-Normandie, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vaur', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Escande', 'Affiliation': 'Radiation oncology department, Oscar Lambret Cancer Centre, Lille, Hauts-de-France, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Serre', 'Affiliation': 'Radiation oncology department, CHU Limoges, Limoges, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lovera', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France jthariat@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038391']
2852,32985994,Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial.,"BACKGROUND


Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision.
OBJECTIVE


This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS.
METHODS


A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m 2  who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory-informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia.
RESULTS


A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes.
CONCLUSIONS


An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12891-019-2801-z.",2020,"An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes.
","['people with knee OA and obesity', 'Participants were people aged 50 years with knee OA and BMI ≥30 kg/m 2  who had undertaken a 12-week', '110 participants (56 SMS group and 54 no SMS', 'people with knee OA and obesity compared with no SMS', 'Knee Osteoarthritis']","['behavior change theory-informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS', 'SMS intervention', 'physiotherapist-supervised exercise program', 'Behavior Change Text Messages']","['higher EARS scores', 'self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia', 'self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",110.0,0.150035,"An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes.
","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bennell', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Carlton, Australia.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Carlton, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Carlton, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kimp', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Carlton, Australia.'}, {'ForeName': 'Samuel Jc', 'Initials': 'SJ', 'LastName': 'Crofts', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Centre for Epidemiology and Biostatistics, Parkville, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Centre for Health, Exercise and Sports Medicine, Carlton, Australia.'}]",Journal of medical Internet research,['10.2196/21749']
2853,32985999,Design and Usability Evaluation of Mobile Voice-Added Food Reporting for Elderly People: Randomized Controlled Trial.,"BACKGROUND


Advances in voice technology have raised new possibilities for apps related to daily health maintenance. However, the usability of such technologies for older users remains unclear and requires further investigation.
OBJECTIVE


We designed and evaluated two innovative mobile voice-added apps for food intake reporting, namely voice-only reporting (VOR) and voice-button reporting (VBR). Each app features a unique interactive procedure for reporting food intake. With VOR, users verbally report the main contents of each dish, while VBR provides both voice and existing touch screen inputs for food intake reporting. The relative usability of the two apps was assessed through the metrics of accuracy, efficiency, and user perception.
METHODS


The two mobile apps were compared in a head-to-head parallel randomized trial evaluation. A group of 57 adults aged 60-90 years (12 male and 45 female participants) was recruited from a retirement community and randomized into two experimental groups, that is, VOR (n=30) and VBR (n=27) groups. Both groups were tested using the same set of 17 food items including dishes and beverages selected and allocated to present distinct breakfast, lunch, and dinner meals. All participants used a 7-inch tablet computer for the test. The resulting data were analyzed to evaluate reporting accuracy and time efficiency, and the system usability scale (SUS) was used to measure user perception.
RESULTS


For eight error types identified in the experiment, the VBR group participants were significantly (P<.001) more error prone owing to the required use of button-tapping actions. The highest error rates in the VOR group were related to incomprehensible reporting speech (28/420, 6.7%), while the highest error rates in the VBR group were related to failure to make required button taps (39/378, 10.3%). The VOR group required significantly (P<.001) less time to complete food reporting. The overall subjective reactions of the two groups based on the SUS surpassed the benchmark and were not significantly different (P=.20).
CONCLUSIONS


Experimental results showed that VOR outperformed VBR, suggesting that voice-only food input reporting is preferable for elderly users. Voice-added apps offer a potential mechanism for the self-management of dietary intake by elderly users. Our study contributes an evidence-based evaluation of prototype design and selection under a user-centered design model. The results provide a useful reference for selecting optimal user interaction design.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Registry ISRCTN17335889; http://www.isrctn.com/ISRCTN17335889.",2020,", the VBR group participants were significantly (P<.001) more error prone owing to the required use of button-tapping actions.","['Elderly People', '57 adults aged 60-90 years (12 male and 45 female participants', 'elderly users', 'older users']","['Mobile Voice-Added Food Reporting', '17 food items including dishes and beverages selected and allocated to present distinct breakfast, lunch, and dinner meals', 'innovative mobile voice-added apps for food intake reporting, namely voice-only reporting (VOR) and voice-button reporting (VBR', 'VBR']","['incomprehensible reporting speech', 'accuracy, efficiency, and user perception', 'reporting accuracy and time efficiency, and the system usability scale (SUS', 'highest error rates', 'overall subjective reactions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0453985', 'cui_str': 'Button'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",57.0,0.0856564,", the VBR group participants were significantly (P<.001) more error prone owing to the required use of button-tapping actions.","[{'ForeName': 'Ying-Chieh', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Cybersecurity Technology Institute, Institute for Information Industry, Taipei, Taiwan.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, Health Promotion Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hsin-Yun', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition Therapy, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Irianti', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan City, Taiwan.'}, {'ForeName': 'Ting-Ni', 'Initials': 'TN', 'LastName': 'Jen', 'Affiliation': 'Department of Chemical and Materials Engineering, College of Engineering, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Jou-Yin', 'Initials': 'JY', 'LastName': 'Yeh', 'Affiliation': 'Department of Health Care Management, College of Management, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Sherry Yueh-Hsia', 'Initials': 'SY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Care Management and Healthy Aging Research Center, College of Management, Chang Gung University, Taoyuan, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/20317']
2854,32980623,Successful implementation of text-based blood pressure monitoring for postpartum hypertension.,"OBJECTIVES


A clinical trial showed postpartum text-based blood pressure (BP) monitoring is effective in meeting clinical guidelines and reduces racial disparities in postpartum hypertension care. Our objective was to compare clinical outcomes to those from a clinical trial after implementation of the program in a second hospital within our hospital system.
STUDY DESIGN


Comparison of women randomized to text-based BP monitoring in a clinical trial compared to an implementation cohort clinically enrolled in text-based BP monitoring. BP outcomes and postpartum visit were compared in bivariate and multivariable analyses.
MAIN OUTCOME MEASURES


BP ascertainment was defined as at least 1 BP texted during the 10 days of monitoring. American College of Obstetricians and Gynecologists (ACOG) recommendation was defined as BP sent on postpartum day 3-4 and again day 7-10.
RESULTS


The implementation cohort had 333 women compared to 103 in the trial cohort. The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001). BP ascertainment (95.5% vs. 92.2%, adjusted OR 1.41, [95% CI 0.55, 3.58]) and proportion meeting ACOG recommendations (84.7% vs. 81.6%, adjusted OR 0.89 [95% CI 0.48, 1.64]) were similar between groups. There were no differences in BP ascertainment among Black and non-Black women in the trial or implementation cohort.
CONCLUSIONS


Text-based BP monitoring performed similarly in an implementation cohort compared to the trial participants. This program is scalable to manage postpartum hypertension and reduce racial disparities in postpartum care in women with hypertensive disorders of pregnancy.",2020,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","['postpartum hypertension', 'women with hypertensive disorders of pregnancy', '333 women compared to 103 in the trial cohort', 'American College of Obstetricians and Gynecologists (ACOG']","['text-based BP monitoring', 'text-based blood pressure monitoring', 'postpartum text-based blood pressure (BP) monitoring']","['BP ascertainment', 'proportion meeting ACOG recommendations', 'BP outcomes and postpartum visit']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0586884', 'cui_str': 'Obstetrician and gynecologist'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.173943,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","[{'ForeName': 'Jourdan E', 'Initials': 'JE', 'LastName': 'Triebwasser', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA; Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: jourdan.triebwasser@pennmedicine.upenn.edu.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: matthew.janssen@pennmedicine.upenn.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Hirshberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: adi.hirshberg@pennmedicine.upenn.edu.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: ssrinivas@pennmedicine.upenn.edu.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.09.001']
2855,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND


The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS


The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS


The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS


This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2020,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
2856,32990248,"Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments.","BACKGROUND


Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD.
OBJECTIVE


This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success.
METHODS


A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted.
RESULTS


We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022.
CONCLUSIONS


This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03780751; https://clinicaltrials.gov/ct2/show/NCT03780751.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20326.",2020,"Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD.
","['266 women with HSDD', 'women with HSDD to a waitlist control group', 'Low Sexual Desire in Women', 'women with HSDD']","['cognitive behavioral and mindfulness-based interventions delivered via the internet', 'Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments']","['sexual desire (primary) and sexual distress (secondary', 'Additional variables (eg, depression, mindfulness, rumination', 'sexual desire and sexuality-related distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086439', 'cui_str': 'Hypokinetic'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]",266.0,0.103337,"Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD.
","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Meyers', 'Affiliation': 'Clinical Psychology and Psychotherapy, Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Margraf', 'Affiliation': 'Clinical Psychology and Psychotherapy, Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Velten', 'Affiliation': 'Clinical Psychology and Psychotherapy, Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr University Bochum, Bochum, Germany.'}]",JMIR research protocols,['10.2196/20326']
2857,32990630,"Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial.","BACKGROUND


Syringe service programs (SSPs) are safe, highly effective programs for promoting health among people who inject drugs. However, resource limitations prevent the delivery of a full package of prevention services to many clients in need. Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings.
OBJECTIVE


The aim of this paper is to assess the effect of a computer-tailored behavioral intervention, called Hep-Net, on safe injection practices, substance use reduction, overdose prevention, and hepatitis C virus (HCV) testing among SSP clients.
METHODS


Using a social network-based recruitment strategy, we recruited clients of an established SSP in Wisconsin and peers from their social networks. Participants completed a computerized baseline survey and were then randomly assigned to receive the Hep-Net intervention. Components of the intervention included an overall risk synthesis, participants' selection of a behavioral goal, and an individualized risk reduction exercise. Individuals were followed up 3 months later to assess their behavior change. The effect of Hep-Net on receiving an HCV screening test, undergoing Narcan training, reducing the frequency of drug use, and sharing drug equipment was assessed. The individual's readiness to change each behavior was also examined.
RESULTS


From 2014 to 2015, a total of 235 people who injected drugs enrolled into the Hep-Net study. Of these, 64.3% (151/235) completed the follow-up survey 3-6 months postenrollment. Compared with the control group, individuals who received the Hep-Net intervention were more likely to undergo HCV testing (odds ratio [OR] 2.23, 95% CI 1.05-4.74; P=.04) and receive Narcan training (OR 2.25, 95% CI 0.83-6.06; P=.11), and they shared drug equipment less frequently (OR 0.06, 95% CI 0.55-0.65; P<.001). Similarly, individuals who received the intervention were more likely to advance in their stage of readiness to change these 3 behaviors. However, intervention participants did not appear to reduce the frequency of drug use or increase their readiness to reduce drug use more than control participants, despite the fact that the majority of the intervention participants selected this as the primary goal to focus on after participation in the baseline survey.
CONCLUSIONS


Implementing computer-based risk reduction interventions in SSPs may reduce harms associated with the sharing of injection equipment and prevent overdose deaths; however, brief computerized interventions may not be robust enough to overcome the challenges associated with reducing and ceasing drug use when implemented in settings centered on the delivery of prevention services.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02474043; https://clinicaltrials.gov/ct2/show/NCT02474043.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/resprot.4830.",2020,"Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings.
","['people who inject drugs', 'recruited clients of an established SSP in Wisconsin and peers from their social networks', 'SSP clients', 'From 2014 to 2015, a total of 235 people who injected drugs enrolled into the Hep-Net study']","['Hep-Net intervention', 'computer-tailored behavioral intervention', 'Hep-Net']","['overdose deaths', 'frequency of drug use, and sharing drug equipment', ""overall risk synthesis, participants' selection of a behavioral goal, and an individualized risk reduction exercise""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1857069', 'cui_str': 'Schöpf-Schulz-Passarge syndrome'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",235.0,0.0773248,"Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings.
","[{'ForeName': 'Karli R', 'Initials': 'KR', 'LastName': 'Hochstatter', 'Affiliation': 'Columbia University School of Social Work, New York, NY, United States.'}, {'ForeName': 'Shawnika J', 'Initials': 'SJ', 'LastName': 'Hull', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington DC, DC, United States.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Marguerite E', 'Initials': 'ME', 'LastName': 'Burns', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Marlon P', 'Initials': 'MP', 'LastName': 'Mundt', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Westergaard', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}]",Journal of medical Internet research,['10.2196/19703']
2858,32990633,The Influence of Three Modes of Human Support on Attrition and Adherence to a Web- and Mobile App-Based Mental Health Promotion Intervention in a Nonclinical Cohort: Randomized Comparative Study.,"BACKGROUND


The escalating prevalence of mental health disorders necessitates a greater focus on web- and mobile app-based mental health promotion initiatives for nonclinical groups. However, knowledge is scant regarding the influence of human support on attrition and adherence and participant preferences for support in nonclinical settings.
OBJECTIVE


This study aimed to compare the influence of 3 modes of human support on attrition and adherence to a digital mental health intervention for a nonclinical cohort. It evaluated user preferences for support and assessed whether adherence and outcomes were enhanced when participants received their preferred support mode.
METHODS


Subjects participated in a 10-week digital mental health promotion intervention and were randomized into 3 comparative groups: standard group with automated emails (S), standard plus personalized SMS (S+pSMS), and standard plus weekly videoconferencing support (S+VCS). Adherence was measured by the number of video lessons viewed, points achieved for weekly experiential challenge activities, and the total number of weeks that participants recorded a score for challenges. In the postquestionnaire, participants ranked their preferred human support mode from 1 to 4 (S, S+pSMS, S+VCS, S+pSMS & VCS combined). Stratified analysis was conducted for those who received their first preference. Preintervention and postintervention questionnaires assessed well-being measures (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing).
RESULTS


Interested individuals (N=605) enrolled on a website and were randomized into 3 groups (S, n=201; S+pSMS, n=202; S+VCS, n=201). Prior to completing the prequestionnaire, a total of 24.3% (147/605) dropped out. Dropout attrition between groups was significantly different (P=.009): 21.9% (44/201) withdrew from the S group, 19.3% (39/202) from the S+pSMS group, and 31.6% (64/202) from the S+VCS group. The remaining 75.7% (458/605) registered and completed the prequestionnaire (S, n=157; S+pSMS, n=163; S+VCS, n=138). Of the registered participants, 30.1% (138/458) failed to complete the postquestionnaire (S, n=54; S+pSMS, n=49; S+VCS, n=35), but there were no between-group differences (P=.24). For the 69.9% (320/458; S, n=103; S+pSMS, n=114; S+VCS, n=103) who completed the postquestionnaire, no between-group differences in adherence were observed for mean number of videos watched (P=.42); mean challenge scores recorded (P=.71); or the number of weeks that challenge scores were logged (P=.66). A total of 56 participants (17.5%, 56/320) received their first preference in human support (S, n=22; S+pSMS, n=26; S+VCS, n=8). No differences were observed between those who received their first preference and those who did not with regard to video adherence (P=.91); challenge score adherence (P=.27); or any of the well-being measures including, mental health (P=.86), vitality (P=.98), depression (P=.09), anxiety (P=.64), stress (P=.55), life satisfaction (P=.50), and flourishing (P=.47).
CONCLUSIONS


Early dropout attrition may have been influenced by dissatisfaction with the allocated support mode. Human support mode did not impact adherence to the intervention, and receiving the preferred support style did not result in greater adherence or better outcomes.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR): 12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx.",2020,"Dropout attrition between groups was significantly different (P=.009): 21.9% (44/201) withdrew from the S group, 19.3% (39/202) from the S+pSMS group, and 31.6% (64/202) from the S+VCS group.","['Interested individuals (N=605) enrolled on a website and were randomized into 3 groups (S, n=201; S+pSMS, n=202; S+VCS, n=201', '56 participants (17.5%, 56/320) received their first preference in human support (S, n=22; S+pSMS, n=26; S+VCS, n=8', 'Subjects participated in a 10-week digital mental health promotion intervention']","['standard group with automated emails (S), standard plus personalized SMS (S+pSMS), and standard plus weekly videoconferencing support (S+VCS', 'digital mental health intervention', 'ANZCTR', 'Web- and Mobile App-Based Mental Health Promotion Intervention']","['Adherence', 'mean challenge scores', 'adherence', 'Dropout attrition', 'mental health (P=.86), vitality (P=.98), depression (P=.09), anxiety (P=.64), stress (P=.55), life satisfaction', 'video adherence (P=.91); challenge score adherence', 'Preintervention and postintervention questionnaires assessed well-being measures (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing']","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",56.0,0.0739025,"Dropout attrition between groups was significantly different (P=.009): 21.9% (44/201) withdrew from the S group, 19.3% (39/202) from the S+pSMS group, and 31.6% (64/202) from the S+VCS group.","[{'ForeName': 'Melanie Elise', 'Initials': 'ME', 'LastName': 'Renfrew', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}, {'ForeName': 'Darren Peter', 'Initials': 'DP', 'LastName': 'Morton', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}, {'ForeName': 'Jason Kyle', 'Initials': 'JK', 'LastName': 'Morton', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}, {'ForeName': 'Jason Scott', 'Initials': 'JS', 'LastName': 'Hinze', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Przybylko', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}, {'ForeName': 'Bevan Adrian', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, Australia.'}]",Journal of medical Internet research,['10.2196/19945']
2859,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND


Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION


What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS


This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE


Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
2860,32987771,"Guideline-Based Statin Eligibility, Coronary Artery Stenosis and Cardiovascular Events in Patients with Stable Chest Pain: A Secondary Analysis of the PROMISE Randomized Clinical Trial.","BACKGROUND


Recommendations for preventive statin treatment in patients with stable chest pain may be difficult as symptoms can be unspecific. It is unclear if coronary CT angiography (CTA)-detected coronary artery disease (CAD) can optimize statin prescription.
METHODS


In stable chest pain patients randomized to CTA in the PROMISE trial, statin eligibility was defined per 2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Primary outcome was a composite of death, myocardial infarction or unstable angina over 26 months median follow-up. Hazard ratios (HR) of non-obstructive (1-69% stenosis) and obstructive (≥70% stenosis) CAD for events were determined using Cox proportional hazard models. Calculated HR were then incorporated into the ACC/AHA pooled cohort equation (PCE) to revised ASCVD risk and assess re-classification of statin eligibility.
RESULTS


Among 3986 patients (60.5 ± 8.2 years; 51% female), 72.9% (2904/3986) were statin eligible. Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2),  p  = 0.142). Although the proportion of statin-eligible patients increased with CAD severity, 54% without CAD were statin eligible. Incorporating information on CAD into PCE reclassified 12.7% of patients (1.3% towards statin, 11.4% towards no statin). Similar results were found in stratified analysis of statin naïve patients (reclassification of 13.9%, 1.0% towards statin, and 12.9% towards no statin). As a result, revised ASCVD risk improved model discrimination in all patients (c-statistic: 0.59 (95 %CI 0.55-0.62) vs. 0.52 (95 %CI 0.49-0.56);  p  0.001), while reducing statin use by 10.1% (62.7% vs. 72.9% statin eligible,  p  0.001).
CONCLUSION


In stable chest pain patients, integration of CAD into guideline recommendations was associated with greater accuracy to reclassify those at increased risk for incident events and a more efficient use of statins.",2020,"Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2),  p  = 0.142).","['Patients with Stable Chest Pain', '3986 patients (60.5 ± 8.2 years; 51% female), 72.9% (2904/3986) were statin eligible', '2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines', 'patients with stable chest pain', 'stable chest pain patients']","['CTA', 'coronary CT angiography (CTA)-detected coronary artery disease (CAD']","['Hazard ratios (HR) of non-obstructive', 'composite of death, myocardial infarction or unstable angina over 26 months median follow-up', 'revised ASCVD risk improved model discrimination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",3986.0,0.0851533,"Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2),  p  = 0.142).","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Pursnani', 'Affiliation': 'Cardiology Division, NorthShore University Health System, Evanston, IL 60201, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Taron', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mayrhofer', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Maros', 'Initials': 'M', 'LastName': 'Ferencik', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles, CA 90024, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27708, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}]",Journal of clinical medicine,['10.3390/jcm9103076']
2861,32964773,Teleaudiology hearing aid fitting follow-up consultations for adults: single blinded crossover randomised control trial and cohort studies.,"OBJECTIVE


To evaluate and compare the effectiveness and quality of standard face-to-face and teleaudiology hearing aid fitting follow-up consultations and blended services for adult hearing aid users.
DESIGN AND STUDY SAMPLE


Fifty-six participants were randomly allocated to two equal groups, with equal numbers of new and experienced users. One standard and one teleaudiology follow-up consultation were delivered by an audiologist, the latter assisted by a facilitator. The order was reversed for the second group. Outcome measurement tools were applied to assess aspects of participants' communication, fitting (physical, sensorial), quality of life, and service. Cross-sectional and longitudinal outcomes were analysed.
RESULTS


Most participants presented with moderate, sloping, and symmetrical sensorineural hearing loss. The duration of teleaudiology (42.96 ± 2.73 min) was equivalent to face-to-face consultations (41.25 ± 2.61 min). All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05). Satisfaction for both consultation modes was high, although significantly greater with standard consultations. The mode and order of delivery of the consultations did not influence the outcomes.
CONCLUSION


Teleaudiology hearing aid follow-up consultations can deliver significant improvements, and do not differ from standard consultations. Blended services also deliver significant improvements. Satisfaction can be negatively impacted by technical or human-related issues.",2020,"All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05).","['adult hearing aid users', 'adults', 'Fifty-six participants']","['standard face-to-face and teleaudiology hearing aid fitting follow-up consultations and blended services', 'Teleaudiology hearing aid fitting follow-up consultations']","['communication, fitting, and quality of life', 'duration of teleaudiology', ""participants' communication, fitting (physical, sensorial), quality of life, and service"", 'Satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",56.0,0.0477665,"All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05).","[{'ForeName': 'Karina F M', 'Initials': 'KFM', 'LastName': 'Tao', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Tais de C', 'Initials': 'TC', 'LastName': 'Moreira', 'Affiliation': 'Department of Social Responsibility, Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Dona M P', 'Initials': 'DMP', 'LastName': 'Jayakody', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'De Wet', 'Initials': 'W', 'LastName': 'Swanepoel', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Brennan-Jones', 'Affiliation': 'Ear Health Team, Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Coetzee', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Eikelboom', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1805804']
2862,32969563,Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer.,"OBJECTIVE


To evaluate the safety and efficacy of cabozantinib combined with docetaxel.
PATIENTS AND METHODS


This was a phase 1/2 multicentre study in patients with metastatic castration-resistant prostate cancer (mCRPC). Docetaxel (75 mg/m 2  every 3 weeks with daily prednisone 10 mg) was combined with escalating doses of daily cabozantinib (20, 40 and 60 mg). Based on the results of the phase 1 study, the investigation was expanded into a randomized study of docetaxel with prednisone (hereafter 'docetaxel/prednisone') plus the maximum tolerated dose (MTD) of cabozantinib compared with docetaxel/prednisone alone.
RESULTS


A total of 44 men with mCRPC were enrolled in this phase 1/2 trial. An MTD of 40 mg cabozantinib plus docetaxel/prednisone was determined. Dose-limiting toxicities were neutropenic fever and palmar-plantar erythrodysesthesia, and there was one death attributable to a thromboembolic event. In addition, grade 3 or 4 myelosuppression, hypophosphataemia and neuropathy were seen in three or more patients. In the phase 1 study, the median time to progression (TTP) and overall survival (OS) time were 13.6 and 16.3 months, respectively. In the phase 2 study, which was terminated early because of poor accrual, the median TTP and OS favoured the combination (n = 13) compared to docetaxel/prednisone alone (n = 12; 21.0 vs 6.6 months; P = 0.035 and 23.8 vs 15.6 months; P = 0.072, respectively).
CONCLUSION


Despite the limited number of patients in this study, preliminary data suggest that cabozantinib can be safely added to docetaxel/prednisone with possible enhanced efficacy.",2020,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"['Metastatic Castrate Resistant Prostate Cancer', 'patients with mCRPC', '44 men with mCRPC']","['cabozantinib vs. docetaxel/prednisone', 'Cabozantinib plus Docetaxel and Prednisone', 'cabozantinib combined with docetaxel', 'docetaxel', 'Docetaxel', 'docetaxel/prednisone']","['median time to progression (TTP) and overall survival', 'median TTP and overall survival', 'neutropenic fever and palmer-plantar erythrodysesthesia', 'safety and efficacy', 'grade 3 or 4 myelosuppression, hypophosphatemia, and neuropathy']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",44.0,0.0319574,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"[{'ForeName': 'Ravi A', 'Initials': 'RA', 'LastName': 'Madan', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Fatima H', 'Initials': 'FH', 'LastName': 'Karzai', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Munjid', 'Initials': 'M', 'LastName': 'Al Harthy', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Arlen', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Rosner', 'Affiliation': 'Center for Prostate Disease Research, Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cordes', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Marijo', 'Initials': 'M', 'LastName': 'Bilusic', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Couvillon', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hankin', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Moniquea', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Guin', 'Initials': 'G', 'LastName': 'Chun', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Owens', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Marte', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yuno', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Trepel', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, NCI, Bethesda, MD, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dahut', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}]",BJU international,['10.1111/bju.15227']
2863,32966290,"Efficacy and safety of praziquantel and dihydroartemisinin piperaquine combination for treatment and control of intestinal schistosomiasis: A randomized, non-inferiority clinical trial.","BACKGROUND


Despite the reported success in reducing morbidity, praziquantel alone is insufficient for the control and elimination of schistosomiasis, partly due to its poor efficacy against the juvenile worms. Artemisinin derivatives are effective against juvenile worms but are less effective against adult worms. We compared the safety and efficacy of praziquantel and Dihydroartemisinin-piperaquine combination against the standard praziquantel alone for treatment of intestinal schistosomiasis.
METHODS


In this randomized, open-label, non-inferiority trial, 639 Schistosoma mansoni infected children were enrolled and randomized to receive either praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination. Two stool samples were collected on consecutive days at baseline, 3 and 8 weeks post-treatment and analyzed using thick smear Kato Katz method. Efficacy was assessed by cure and egg reduction rates at 3 and 8 weeks post-treatment. Adverse events were assessed within four hours of drugs intake. The primary outcome was cure rates at 8 weeks of post-treatment. Secondary outcomes were egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events.
RESULTS


At 3 weeks of post-treatment, cure rates were 88.3% (263/298, 95% CI = 84.1%- 91.4%) and 81.2% (277/341, 95% CI = 76.7%- 85.0%) for the combination therapy and praziquantel alone, respectively (p < 0.01, odds ratio (OR) = 1.74, 95% CI of OR = 1.11 to 2.69). At 8 weeks, there was a significant drop in the cure rates in praziquantel alone group to 63.9% (218/341, 95% CI = 58.7%- 68.8%) compared to 81.9% (244/298, 95% CI = 77.1%- 85.8%) in the combination therapy group (p < 0.0001, OR = 2.55, 95%CI of OR = 1.75 to 3.69). Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01). On both Univariate and Multivariate regression analysis, type of treatment received was a significant predictor of cure at week 8 post-treatment. Overall, 30.8% (95% CI = 27.2%- 34.4%) of the study participants experienced mild and transient treatment-associated adverse events, post-treatment abdominal pain (27.1%) being the most common adverse event observed. There was no significant difference in the overall occurrence of adverse events between the two treatment groups.
CONCLUSION


Praziquantel and Dihydroartemisinin piperaquine combination therapy is safe, and more efficacious compared to praziquantel alone for the treatment of intestinal schistosomiasis. Further studies are needed to explore if the combination therapy can be considered as an option for mass drug administration to control and eventually eliminate schistosomiasis.",2020,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"['639 Schistosoma mansoni infected children', 'intestinal schistosomiasis']","['praziquantel and dihydroartemisinin piperaquine combination', 'praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination', 'Praziquantel and Dihydroartemisinin piperaquine combination therapy', 'praziquantel and Dihydroartemisinin-piperaquine combination']","['mild and transient treatment-associated adverse events, post-treatment abdominal pain', 'Egg reduction rates', 'egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events', 'overall occurrence of adverse events', 'Adverse events', 'safety and efficacy', 'Efficacy and safety', 'Efficacy', 'cure rates', 'cure and egg reduction rates']","[{'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242497', 'cui_str': 'Intestinal schistosomiasis'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",639.0,0.259822,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"[{'ForeName': 'Rajabu Hussein', 'Initials': 'RH', 'LastName': 'Mnkugwe', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'National Institute for Medical Research (NIMR), Mwanza Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Appolinary', 'Initials': 'A', 'LastName': 'Kamuhabwa', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Aklillu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska University Hospital-Huddinge, Karolinska Institutet, Stockholm, Sweden.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008619']
2864,32966294,"The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.","PURPOSE


Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer.
METHODS


We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer.
RESULTS


A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group.
CONCLUSIONS


The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion.
TRIAL REGISTRATION


CRISKCT0003386; https://cris.nih.go.kr (20181207).",2020,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","['83 women with breast cancer', 'upper extremity dysfunction after ALND', 'breast cancer surgery', 'patients who underwent breast cancer surgery', 'patients with breast cancer']","['poloxamer and sodium alginate mixture (Guardix-SG®', 'Guardix-SG®']","['Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer', 'adverse effect', 'shoulder ROM', 'shoulder range of motion (ROM', 'shoulder ROM at baseline (T0) and 3 (T1), 6 (T2']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1698635', 'cui_str': 'Upper extremity dysfunction'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600615', 'cui_str': 'Poloxamer'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C3852262', 'cui_str': 'guardix'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",83.0,0.183932,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","[{'ForeName': 'Sae Byul', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Gwark', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Sohn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Il Yong', 'Initials': 'IY', 'LastName': 'Chung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Beom Seok', 'Initials': 'BS', 'LastName': 'Ko', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sei-Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Junghwa', 'Initials': 'J', 'LastName': 'Do', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Ulsan University Hospital, Ulsan, Korea.'}, {'ForeName': 'Eunhae', 'Initials': 'E', 'LastName': 'Um', 'Affiliation': 'Department of Surgery, Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Tae In', 'Initials': 'TI', 'LastName': 'Yoon', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Dongnam institute of Radiological and medical science, Busan, Korea.'}, {'ForeName': 'Sung-Ui', 'Initials': 'SU', 'LastName': 'Jung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Kosin University Gospel Hospital, Busan, Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Byung Ho', 'Initials': 'BH', 'LastName': 'Son', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0238284']
2865,32966320,Comparison of hypobaric hypoxia symptoms between a recalled exposure and a current exposure.,"BACKGROUND


Aircrew members are required to attend hypoxia awareness training regularly to strengthen their memory of their personal hypoxia symptoms by undergoing training inside a hypobaric chamber. The aim of this study was to examine the association between hypoxia symptoms experienced during two training sessions that were 4 years apart.
METHODS


This was a crossover study to compare hypoxia symptoms and self-reported physiological effects of trapped gas between a previous training session and a current training session in an altitude chamber. The subjects were military crew members who undertook a 25,000-feet refresher training course in 2018. We used a structured questionnaire to obtain the target information before and during hypoxia exposure. Data were analyzed using SPSS software.
RESULTS


A total of 341 trainees participated in this survey and completely filled out the questionnaire. Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions. Frequently reported symptoms were poor concentration (30.5%), impaired cognitive function (20.5%), visual disturbances (16.4%), hot flashes (15.8%), and paresthesia (12.6%) during both exposures. However, the proportions of participants reporting poor concentration (P = 0.378) and visual disturbances (P = 0.594) were not significantly different between the recalled and current training sessions. The five most common symptoms among the subjects with less than 1,000 flight hours were poor concentration (29.8%), visual disturbance (27.3%), impaired cognitive function (14.9%), dizziness/lightheadedness (11.6%), and hot flashes (9.9%), which overlapped substantially with the symptoms reported by other subjects. The occurrence of those five most common symptoms in the group with more than 1,000 flight hours did not significantly differ between the recalled training session and the current training session.
CONCLUSIONS


The most common hypoxia symptoms reported were similar between the recalled and current training sessions in an environment with a low oxygen concentration. This finding was also clearly affected by the duration of flight experience. Moreover, GI effects of the expansion of trapped gas were commonly observed at low atmospheric pressure.",2020,Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions.,"['341 trainees participated in this survey and completely filled out the questionnaire', 'subjects were military crew members who undertook a 25,000-feet refresher training course in 2018']",[],"['visual disturbances', 'hot flashes', 'paresthesia', 'dizziness/lightheadedness', 'Gastrointestinal tract discomfort', 'visual disturbance', 'impaired cognitive function']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",[],"[{'cui': 'C0547030', 'cui_str': 'Visual disturbance'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",341.0,0.0192821,Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions.,"[{'ForeName': 'Min-Yu', 'Initials': 'MY', 'LastName': 'Tu', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Kwo-Tsao', 'Initials': 'KT', 'LastName': 'Chiang', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Chao-Chien', 'Initials': 'CC', 'LastName': 'Cheng', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Fang-Ling', 'Initials': 'FL', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital Beitou Branch, National Defense Medical Center, Taipei City, Taiwan.'}, {'ForeName': 'Yu-His', 'Initials': 'YH', 'LastName': 'Wen', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Sing-Hong', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Chung-Yu', 'Initials': 'CY', 'LastName': 'Lai', 'Affiliation': 'Graduate Institute of Aerospace and Undersea Medicine, National Defense Medical Center, Taipei City, Taiwan.'}]",PloS one,['10.1371/journal.pone.0239194']
2866,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
2867,32966971,Exenatide and Renal Outcomes in Patients with Type 2 Diabetes and Diabetic Kidney Disease.,"BACKGROUND


Cardiovascular outcomes in clinical trials with type 2 diabetes mellitus (T2DM) patients have shown that glucagon-like peptide-1 receptor agonist can have a beneficial effect on the kidney. This trial aimed to assess the effects of exenatide on renal outcomes in patients with T2DM and diabetic kidney disease (DKD).
METHODS


We performed a randomized parallel study encompassing 4 general hospitals. T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h were randomized 1:1 to receive exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine (control group) for 24 weeks. The primary outcome was the UAER percentage change from the baseline after 24 weeks of intervention. The rates of hypoglycemia, adverse events (AEs), and change in eGFR during the follow-up were measured as safety outcomes.
RESULTS


Between March 2016 and April 2019, 92 patients were randomized and took at least 1 dose of the study drug. The mean age of the participants was 56 years. At baseline, the median UAER was 1,512.0 mg/24 h and mean eGFR was 70.4 mL/min/1.73 m2. After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255). Moreover, the body weight declined by 1.3 kg in the intervention group (the difference between the 2 groups was 2.7 kg, p = 0.0001). Compared to the control group, a lower frequency of hypoglycemia and more gastrointestinal AEs were observed in the intervention group.
CONCLUSION


Exenatide plus insulin glargine treatment for 24 weeks resulted in a reduction of albuminuria in T2DM patients with DKD.",2020,"After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255).","['type 2 diabetes mellitus (T2DM) patients', '92 patients', 'patients with T2DM and diabetic kidney disease (DKD', 'Between March 2016 and April 2019', '4 general hospitals', 'Patients with Type 2 Diabetes and Diabetic Kidney Disease', 'T2DM patients with DKD', 'T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h']","['exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine', 'Exenatide plus insulin glargine', 'exenatide', 'Exenatide']","['reduction of albuminuria', 'UAER percentage change', 'median UAER', 'safety outcomes', 'body weight', 'rates of hypoglycemia, adverse events (AEs), and change in eGFR', 'frequency of hypoglycemia and more gastrointestinal AEs', 'renal outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C4068885', 'cui_str': '0.3'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",92.0,0.0767787,"After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255).","[{'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shuyue', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Mengchen', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianlu', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Xianyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Gugen', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China, xueyaoming999@126.com.'}]",American journal of nephrology,['10.1159/000510255']
2868,32968158,Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial.,"In this multicentre double-blind randomized clinical trial, we investigated the effects of oral cholecalciferol supplementation on serum hepcidin and parameters related to anaemia and CKD-MBD among haemodialysis patients. Participants were assigned in a 2:2:1:1 ratio to either (1) thrice-weekly 3,000-IU cholecalciferol, (2) once-monthly cholecalciferol (equivalent to 9,000 IU/week), (3) thrice-weekly placebo, or (4) once-monthly placebo. We also examined the effect modifications by selected single nucleotide polymorphisms in vitamin D-related genes. Out of 96 participants, 94 were available at Month 3, and 88 completed the 6-month study. After adjustment for baseline values, serum hepcidin levels were higher at Day 3 in the combined cholecalciferol (vs. placebo) group, but were lower at Month 6 with increased erythropoietin resistance. Cholecalciferol increased serum 1,25(OH) 2 D levels, resulting in a greater proportion of patients who reduced the dose of active vitamin D at Month 6 (31% vs. 10% in the placebo group). Cholecalciferol also suppressed intact PTH only among patients with severe vitamin D deficiency. In conclusion, cholecalciferol supplementation increases serum hepcidin-25 levels in the short term and may increase erythropoietin resistance in the long term among haemodialysis patients. Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.Clinical Trial Registry: This study was registered at ClinicalTrials.gov and University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as NCT02214563 (registration date: 12/08/2014) and UMIN000011786 (registration date: 15/08/2014), respectively (please refer to the links below). ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT02214563 . UMIN-CTR: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000017152&language=E .",2020,"Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.","['96 participants, 94 were available at Month 3, and 88 completed the 6-month study', 'haemodialysis patients', 'patients with severe vitamin D deficiency']","['combined cholecalciferol (vs. placebo', 'cholecalciferol', 'placebo, or (4) once-monthly placebo', 'oral cholecalciferol supplementation', 'thrice-weekly 3,000-IU cholecalciferol, (2) once-monthly cholecalciferol', 'Cholecalciferol', 'cholecalciferol supplementation']","['serum hepcidin and parameters related to anaemia and CKD-MBD', 'serum 1,25(OH) 2 D levels', 'serum hepcidin and parameters of anaemia and CKD-MBD', 'serum hepcidin levels', 'serum hepcidin-25 levels', 'erythropoietin resistance', 'serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4076240', 'cui_str': 'Chronic kidney disease mineral and bone disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",96.0,0.589539,"Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.","[{'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. hamatea@kid.med.osaka-u.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shimomura', 'Affiliation': 'Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Namba-Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mikami', 'Affiliation': 'Department of Internal Medicine, Higashikouri Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishi', 'Affiliation': 'Nishi Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Akebono Clinic, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kamoto', 'Affiliation': 'Futaba Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Obi Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Tomosugi', 'Affiliation': 'Division of Advanced Medicine, Medical Research Institute, Kanazawa Medical University, Kawakita, Ishikawa, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Tsubakihara', 'Affiliation': 'Division of Management in Health Care Sciences, Graduate School of Health Care Sciences, Jikei Institute, Osaka, Osaka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-72385-w']
2869,32971040,Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.,"BACKGROUND


Patients with type 2 diabetes have a high risk of developing chronic kidney disease. We examined the effects of semaglutide on kidney function and safety in a large, broad type 2 diabetes population.
METHODS


We did a post-hoc analysis of 8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5 and SUSTAIN 7 randomised controlled trials, and the SUSTAIN 6 cardiovascular outcomes trial, to examine the effects of once-weekly subcutaneous semaglutide 0·5 mg and 1·0 mg versus comparators (active treatments or placebo) on estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events. Data from SUSTAIN 1-5 and SUSTAIN 7 were pooled. eGFR and UACR were also analysed by kidney function and albuminuria status.
FINDINGS


In SUSTAIN 1-5 and SUSTAIN 7, eGFR decreased from baseline to week 12 with all active treatments; estimated treatment differences (ETDs) versus placebo were -2·15 (95% CI -3·47 to -0·83) mL/min per 1·73 m 2  with semaglutide 0·5 mg and -3·00 (-4·31 to -1·68) mL/min per 1·73 m 2  with semaglutide 1·0 mg; after week 12, eGFR plateaued. In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58 [95% CI -2·92 to -0·25] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -2·02 [-3·35 to -0·68] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 6, the decline in eGFR was greater with semaglutide than with placebo from baseline to week 16 (ETD -1·29 [95% CI -2·07 to -0·51] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -1·56 [-2·33 to -0·78] mL/min per 1·73 m 2  with semaglutide 1·0 mg), but not from week 16 to week 104 (1·29 [0·30 to 2·28] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 2·44 [1·45 to 3·44] mL/min per 1·73 m 2  with semaglutide 1·0 mg). Overall (ie, from baseline to week 104), the eGFR decline in SUSTAIN 6 was similar between semaglutide and placebo (ETD 0·07 [95% CI -0·92 to 1·07] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 0·97 [-0·03 to 1·97] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 1-5, UACR ratios at end of treatment to baseline were 0·917 with semaglutide 0·5 mg, 0·836 with semaglutide 1·0 mg, and 1·239 with placebo; at end of treatment, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·74 [95% CI 0·64 to 0·85] for semaglutide 0·5 mg and 0·68 [0·59 to 0·78] for semaglutide 1·0 mg). In SUSTAIN 6, UACR ratios at end of treatment (week 104) to baseline were 0·973 with semaglutide 0·5 mg, 0·858 with semaglutide 1·0 mg, and 1·302 with placebo; at week 104, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·75 [95% CI 0·66 to 0·85] for semaglutide 0·5 mg and 0·66 [0·58 to 0·75] for semaglutide 1·0 mg). In SUSTAIN 1-7, eGFR initially declined in patients with normal kidney function (and in those with mild kidney impairment with semaglutide 1·0 mg in SUSTAIN 6), but overall (ie, by week 30 for SUSTAIN 1-5 and SUSTAIN 7, and week 104 for SUSTAIN 6), eGFR did not differ between semaglutide and placebo. In SUSTAIN 1-6, UACR decreased in patients with pre-existing microalbuminuria or macroalbuminuria at baseline; it did not change or increased in those with normoalbuminuria at baseline. Kidney adverse events were balanced between treatment groups.
INTERPRETATION


Across the SUSTAIN 1-7 trials, semaglutide was associated with initial reductions in eGFR that plateaued, and marked reductions in UACR. This post-hoc analysis suggests no increase in the risk of kidney adverse events with semaglutide versus the active comparators used across SUSTAIN 1-7.
FUNDING


Novo Nordisk.",2020,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","['Patients with type 2 diabetes', 'patients with type 2 diabetes', '8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5']","['semaglutide', '0·5 mg and -3·00 ', '0·25', 'once-weekly subcutaneous semaglutide 0·5', 'once-weekly subcutaneous semaglutide', 'placebo (ETD -1·58', '4·31 to -1·68', '1·56', ' mL/min per 1·73 m 2  with semaglutide 0·5', 'placebo', 'semaglutide 0·5 mg and -2·02', '0·51] mL/min per 1·73 m 2  with semaglutide 0·5', '2·33 to -0·78', 'mg and 1·0 mg versus comparators (active treatments or placebo']","['eGFR and UACR', 'kidney function and albuminuria status', 'decline in eGFR', 'UACR ratios', 'kidney function and safety', 'eGFR decline', 'UACR', 'eGFR', 'risk of kidney adverse events', 'Kidney adverse events', 'estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events', 'normal kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",8416.0,0.16795,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; Friedrich Alexander University of Erlangen-Nürnberg, Erlangen, Germany. Electronic address: johannes.mann@kms.mhn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Heart and Vascular Institute, Overland Park, Overland Park, KS, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center -Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30313-2']
2870,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE


Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS


In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS


Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION


In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
2871,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2872,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2873,32972315,Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis.,"BACKGROUND AND PURPOSE


This analysis examined the frequency of dural arteriovenous fistulae (dAVF) after cerebral venous thrombosis (CVT) in patients included in a randomized controlled trial comparing dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT [A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis]), who had systematic follow-up magnetic resonance (MR) imaging.
METHODS


RE-SPECT CVT was a Phase 3, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded end point adjudication. We allocated patients with acute CVT to dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensional phase-contrast venography, and 3-dimensional contrast-enhanced MR venography at the end of the treatment period. A blinded adjudication committee assessed the presence of dAVF in a predefined substudy of the trial.
RESULTS


We analyzed development of dAVF in 112 of 120 randomized patients; 57 allocated to dabigatran and 55 to warfarin. For 3 (2.7%) of these 112 patients, quality of follow-up imaging was insufficient to evaluate dAVF. A dAVF (Borden I) was found in 1 patient (0.9%) allocated to warfarin; however, this dAVF was already present at baseline. The patient did not present with hemorrhage at baseline or during the trial and was asymptomatic at follow-up.
CONCLUSIONS


Despite systematic imaging, we found no new dAVF 6 months after CVT. Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02913326.",2020,"Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield.
","['112 of 120 randomized patients; 57 allocated to', 'Patients With Cerebral Venous and Dural Sinus Thrombosis']","['Dabigatran Etexilate With Warfarin', 'warfarin', 'dabigatran and 55 to warfarin', 'dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT', 'dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensionalphase-contrast venography, and 3-dimensional contrast-enhanced MR venography']","['frequency of dural arteriovenous fistulae (dAVF', 'Dural Arteriovenous Fistulae']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0010271', 'cui_str': 'Dural sinus'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C1690005', 'cui_str': 'MRI venography'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}]",120.0,0.193279,"Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield.
","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ferro', 'Affiliation': 'Serviço de Neurologia, Department of Neurosciences and Mental Health, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Portugal (J.M.F.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.).'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Neuroradiology, University of Kiel, Germany (O.J.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Neurologische Klinik, Abteilung für Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany (M.B.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Dentali', 'Affiliation': 'Department of Medicine and Surgery, Insubria University, Varese, Italy (F.D.).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland (A.K.).'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van der Veen', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.).'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Caria', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany (J.C.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Huisman', 'Affiliation': 'Boehringer Ingelheim B.V., Alkmaar, the Netherlands (H.H.).'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Faculty of Medicine, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.031235']
2874,32986748,"Efficacy of processed amaranth-containing bread compared to maize bread on hemoglobin, anemia and iron deficiency anemia prevalence among two-to-five year-old anemic children in Southern Ethiopia: A cluster randomized controlled trial.","BACKGROUND


Few studies have evaluated iron-rich plant-based foods, such as amaranth grain, to reduce anemia and iron deficiency anemia. Amaranth is rich in nutrients, but with high level of phytate. The objective of this trial was to evaluate the efficacy of home processed amaranth grain containing bread in the treatment of anemia, hemoglobin concentration and iron deficiency anemia among two-to-five year-old children in Southern Ethiopia.
METHOD


Children with anemia (hemoglobin concentration <110.0g/L) (N = 100) were identified by random sampling and enrolled in a 1:1 cluster randomized controlled trial for six months in 2017. The amaranth group (N = 50), received 150g bread containing 70% amaranth and 30% chickpea, the amaranth grain was processed at home (soaking, germinating, and fermenting) to decrease the phytate level. The maize group (N = 50), received 150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread. Hemoglobin, ferritin, and CRP were measured at baseline and at the end of intervention. Hemoglobin and ferritin values were adjusted for altitude and infection, respectively. Generalized estimating equation and generalized linear model were used to analyze the data.
RESULT


In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR: 0.39 (95%CI: 0.16-0.77)]. Hemoglobin concentration estimate of beta coefficient was significantly higher in the amaranth group compared with the maize group [aβ 8.9g/L (95%CI: 3.5-14.3)], p-value <0.01. The risk of iron deficiency anemia is significantly lower in the amaranth group [aRR: 0.44 (95%CI: 0.23-0.83)] in the intention to treat analysis but not significant in the complete case analysis. There was no significant difference between groups in iron deficiency [aRR: 0.81 (95%CI: 0.55-1.19)].
CONCLUSION


Processed amaranth bread had favorable effects on hemoglobin concentration and has the potential to minimize anemia prevalence.
CLINICAL TRIAL REGISTRATION


Trial registry number: PACTR201705002283263 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2283.",2020,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","['two-to-five year-old children in Southern Ethiopia', 'Children with anemia (hemoglobin concentration <110.0g/L', 'two-to-five year-old anemic children in Southern Ethiopia']","['150g bread containing 70% amaranth and 30% chickpea, the amaranth grain', '150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread', 'processed amaranth-containing bread compared to maize bread', 'home processed amaranth grain containing bread']","['Hemoglobin concentration estimate of beta coefficient', 'Hemoglobin, ferritin, and CRP', 'anemia, hemoglobin concentration and iron deficiency anemia', 'risk of iron deficiency anemia', 'Hemoglobin and ferritin values', 'hemoglobin, anemia and iron deficiency anemia prevalence', 'iron deficiency [aRR: 0.81', 'hemoglobin concentration', 'anemia prevalence', 'risk ratios, aRR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",100.0,0.17653,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","[{'ForeName': 'Alemselam Zebdewos', 'Initials': 'AZ', 'LastName': 'Orsango', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Ingunn Marie S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0239192']
2875,32991606,"Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial.","INTRODUCTION


At present, information about clinical efficacy and adverse events of controlled release (CR) form of pelubiprofen, a prodrug of 2-arylopropionic acid with relatively selective effects on cyclooxygenase-2 activity, remains scarce. In this study, we sought to determine non-inferiority of pelubiprofen CR 90 mg/day compared to aceclofenac 200 mg/day regarding clinical efficacy and adverse events after a 4-week course of medication in the patients with symptomatic knee osteoarthritis.
MATERIALS AND METHODS


A total of 191 patients were randomly assigned to take either pelubiprofen CR 90 mg (n = 95) or aceclofenac 200 mg (n = 96). The primary outcome variable was non-inferiority of pain reduction between baseline and week 4 when assessed using a 100 mm pain visual analogue scale (VAS). Pelubiprofen was considered non-inferior to aceclofenac if the upper limit of the one-sided 97.5% confidence interval for the difference in terms of pain VAS was above 15 mm (the average change of pain VAS in the pelubiprofen group-pain VAS reduction in the aceclofenac group). Secondary outcome variables were the changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes at weeks 2 and 4 as compared to baseline, patient global assessment at weeks 2 and 4. The frequency and amount of rescue medicine usage at weeks 2 and 4 were also evaluated as the secondary outcome variable. For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations were assessed and conducted at each follow-up visit.
RESULTS


At week 4, the pain VAS values were significantly reduced in both groups receiving either pelubiprofen CR 90 mg or aceclofenac 200 mg as compared to the baseline. However, the pelubiprofen group and the aceclofenac group respectively showed the pain VAS changes of -22 and -21.9 in the pre-protocol set and -20.8 and -21.7 in the full analysis set, confirming non-inferiority. The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
CONCLUSIONS


Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis.",2020,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","['symptomatic knee osteoarthritis', 'A total of 191 patients', 'patients with symptomatic knee osteoarthritis']","['pelubiprofen CR 90 mg/day compared to aceclofenac', 'Pelubiprofen CR', 'pelubiprofen CR', 'pelubiprofen', 'aceclofenac', 'pelubiprofen CR 90 mg or aceclofenac', 'Pelubiprofen', 'pelubiprofen CR and aceclofenac']","['pain visual analogue scale (VAS', 'frequency and amount of rescue medicine usage', 'pain VAS changes', 'For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations', 'adverse events', 'pain VAS values', 'Efficacy and safety', 'pain VAS', 'non-inferiority of pain reduction', 'changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045712', 'cui_str': 'pelubiprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",191.0,0.155177,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","[{'ForeName': 'Joung Youp', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Moon Jong', 'Initials': 'MJ', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Inha University Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Gon', 'Initials': 'HG', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Dankook University Hospital, Cheonan-si, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Sahnghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Beom', 'Initials': 'SB', 'LastName': 'Han', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Han Jun', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Chung-Ang University, School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Wan', 'Initials': 'YW', 'LastName': 'Moon', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University School of Medicine, Ewha Medical Research Center, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238024']
2876,32991946,The feasibility of a personality targeted intervention for addictive overeating: FoodFix.,"Recent reviews have identified potential treatment targets for addictive overeating. These include: motivational interviewing, development of specific coping strategies for emotional regulation and the use of harm minimisation strategies based on interventions for substance use disorders. However, there is very little experiential evidence. The aim of this study was to determine the feasibility of a personality-targeted motivational interviewing intervention in adults above the healthy-weight range with symptoms of addictive eating, to reduce symptoms of addictive overeating and improve dietary profiles. Individuals with overweight and obesity (BMI >25 kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS) were recruited to a three-session intervention held over 3 months. Sessions were conducted by telehealth and facilitated by dietitians. Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ± 12.2yrs, mean BMI 36.7 ± 6.8 kg/m 2 , 96% female). At three month follow up, there were significant reductions from baseline (BL) for both groups in total YFAS 2.0 symptoms, however, these changes were not significantly different between groups (intervention BL 8.0 ± 2.7; 3-months 6.5 ± 3.8, control BL 8.1 ± 2.5; 3-months 6.9 ± 3.9, p > 0.05). At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p < 0.01). The FoodFix intervention provides insight to the development of future management interventions for addictive eating.",2020,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","['Individuals with overweight and obesity (BMI >25kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS', 'Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ±12.2yrs, mean BMI 36.7±6.8kg/m 2 , 96% female', 'adults above the healthy-weight range with symptoms of addictive eating']","['personality-targeted motivational interviewing intervention', 'FoodFix intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],52.0,0.0215587,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: Tracy.Burrows@newcastle.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: rebecca.collins10@newcastle.edu.au.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: megan.rollo@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: mark.leary@uon.edu.au.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, NSW, Australia. Electronic address: l.hides@uq.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, Canada. Electronic address: cdavis@yorku.ca.'}]",Appetite,['10.1016/j.appet.2020.104974']
2877,32992190,Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.,"BACKGROUND


The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.
METHODS


This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.
RESULTS


The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
CONCLUSION


This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.",2020,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
",['patients who did not have a primary endpoint within 90 days after enrollment (n\xa0=\xa0397'],"['aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS', 'Dual Antiplatelet Therapy', 'clopidogrel', 'aspirin']","['stroke rate', 'major hemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",397.0,0.0576875,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: abdulara@musc.edu.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States. Electronic address: gcotson@emory.edu.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Holmstedt', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: holmsted@musc.edu.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: mchimow@musc.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105254']
2878,32992206,Impact of a Pre-Discharge Education Session on Stroke Knowledge: a Randomized Trial.,"BACKGROUND AND PURPOSES


Stroke knowledge, awareness of risk factors and stroke warning symptoms is very poor among stroke survivors. We investigated whether a pre-discharge education intervention in the stroke unit could improve stroke knowledge in patients with TIA or minor stroke.
METHODS


We performed a prospective single-center, randomized controlled trial (2013-2016) in patients with TIA or minor stroke. The intervention consisted in an interactive group session focused on stroke education, within the stroke unit before hospital discharge. Primary outcome was the 3-month change in stroke knowledge score (SKS) from randomization. Secondary outcomes were the 12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence.
RESULTS


A total of 199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women) were randomized (99 in stroke education session). Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001). This difference was significantly maintained at 12 months. The number of risk factors and warning signs named were significantly increased in the intervention group at 3 months. Control of risk factors and self-reported adherence did not differ significantly between the two groups.
CONCLUSIONS


An interactive education session in the stroke unit significantly improved stroke knowledge at 3 months and 12 months in patients with TIA or minor stroke.",2020,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","['patients with TIA or minor stroke', '199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women']","['Pre-Discharge Education Session', 'pre-discharge education intervention']","['number of risk factors and warning signs named', 'SKS', '3-month change in stroke knowledge score (SKS', 'stroke knowledge', '12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence', 'Stroke Knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",199.0,0.144626,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","[{'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Benoit', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France. Electronic address: charline.benoit@aphp.fr.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Loiseau', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105272']
2879,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND


Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS


Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS


Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS


A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
2880,32992440,"Gastrointestinal Tolerance of Low, Medium and High Dose Acute Oral l-Glutamine Supplementation in Healthy Adults: A Pilot Study.","l-Glutamine (GLN) is a conditionally essential amino acid which supports gastrointestinal (GI) and immune function prior to catabolic stress (e.g., strenuous exercise). Despite potential dose-dependent benefits, GI tolerance of acute high dose oral GLN supplementation is poorly characterised. Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH) g·kg·FFM -1  GLN beverages, in a randomised, double-blind, counter-balanced, cross-over trial. Individual and accumulated GI symptoms were recorded using a visual analogue scale at regular intervals up to 24-h post ingestion. GLN beverages were characterised by tonicity measurement and microscopic observations. 24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p  < 0.05). Specific GI symptoms (discomfort, nausea, belching, upper GI pain) were all more pronounced on the HIGH versus LOW GLN trial ( p  < 0.05). Nevertheless, most symptoms were still rated as mild. In comparison, the remaining GI symptoms were either comparable (flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness) between trials ( p  > 0.05). All beverages were isotonic and contained a dose-dependent number of GLN crystals. Acute oral GLN ingestion in dosages up to 0.9 g·kg·FFM -1  are generally well-tolerated. However, the severity of mild GI symptoms appeared dose-dependent during the first two hours post prandial and may be due to high-concentrations of GLN crystals.",2020,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p  < 0.05).","['Healthy Adults', 'Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH']","['l-Glutamine (GLN', 'Low, Medium and High Dose Acute Oral l-Glutamine Supplementation']","['24-h accumulated upper- and lower- and total-GI symptoms', 'severity of mild GI symptoms', 'Specific GI symptoms (discomfort, nausea, belching, upper GI pain', 'Individual and accumulated GI symptoms', 'flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0687713', 'cui_str': 'Gastrointestinal pain'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162287', 'cui_str': 'Abnormal feces'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",14.0,0.160877,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p  < 0.05).","[{'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Ogden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Child', 'Affiliation': 'School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Fallowfield', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Delves', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Westwood', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Millyard', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Layden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}]",Nutrients,['10.3390/nu12102953']
2881,32992491,The Impact of Controlled Ovarian Stimulation Hormones on the Metabolic State and Endocannabinoid System of Human Cumulus Cells.,"Different Follicle Stimulating Hormone (FSH) formulation and Luteinizing Hormone (LH) are used in Assisted Reproductive Technology (ART) to induce follicles development and oocytes maturation, but it is still under debate which protocol is to be preferred. In the present study, the different effects on cumulus cells (CCs) of three controlled ovarian stimulation (COS) protocols, based on urinary FSH, recombinant FSH, or human Menopausal Gonadotropin (hMG) administration, were assessed. CCs were obtained from 42 normal-responders women undergoing COS, randomly divided into three groups according to the used gonadotropin formulation. Differences were found in the expression of genes belonging to the endocannabinoid system (the receptors  CNR1 ,  CNR2  and  TRPV1 , and the enzymes involved in the metabolisms of anandamide,  NAPE-PLD  and  FAAH , and 2-acylglycerol,  DAGL  and  MAGL ); consistently, changes in lipid ( PPAR α, and  FASN ) and carbohydrate ( GLUT1  and  GLUT9 ) metabolisms, in CCs' macromolecules composition (highlighted by Fourier Transform Infrared Microspectroscopy, FTIRM), and in the number of retrieved oocytes were found. For the first time, statistically significant evidence on the differences related to each COS protocol on the endocannabinoid system, metabolism and macromolecular composition of CCs was found, representing a proof of concept to be further confirmed in a larger cohort of patients.",2020,"Differences were found in the expression of genes belonging to the endocannabinoid system (the receptors  CNR1 ,  CNR2  and  TRPV1 , and the enzymes involved in the metabolisms of anandamide,  NAPE-PLD  and  FAAH , and 2-acylglycerol,  DAGL  and  MAGL ); consistently, changes in lipid ( PPAR α, and  FASN ) and carbohydrate ( GLUT1  and  GLUT9 ) metabolisms, in CCs' macromolecules composition (highlighted by Fourier Transform Infrared Microspectroscopy, FTIRM), and in the number of retrieved oocytes were found.","['Human Cumulus Cells', '42 normal-responders women undergoing COS']","['gonadotropin formulation', 'Controlled Ovarian Stimulation Hormones', 'Follicle Stimulating Hormone (FSH) formulation and Luteinizing Hormone (LH']","['endocannabinoid system, metabolism and macromolecular composition of CCs', 'lipid ( PPAR α, and  FASN ) and carbohydrate ( GLUT1  and  GLUT9 ) metabolisms', 'urinary FSH, recombinant FSH, or human Menopausal Gonadotropin (hMG']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]","[{'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}]",,0.0209458,"Differences were found in the expression of genes belonging to the endocannabinoid system (the receptors  CNR1 ,  CNR2  and  TRPV1 , and the enzymes involved in the metabolisms of anandamide,  NAPE-PLD  and  FAAH , and 2-acylglycerol,  DAGL  and  MAGL ); consistently, changes in lipid ( PPAR α, and  FASN ) and carbohydrate ( GLUT1  and  GLUT9 ) metabolisms, in CCs' macromolecules composition (highlighted by Fourier Transform Infrared Microspectroscopy, FTIRM), and in the number of retrieved oocytes were found.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Notarstefano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, 60131 Ancona, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Gioacchini', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, 60131 Ancona, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Giorgini', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, 60131 Ancona, Italy.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Montik', 'Affiliation': 'Clinica Ostetrica Ginecologica, Università Politecnica delle Marche, Ospedale G. Salesi, Via F. Corridoni 11, 60121 Ancona, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ciavattini', 'Affiliation': 'Clinica Ostetrica Ginecologica, Università Politecnica delle Marche, Ospedale G. Salesi, Via F. Corridoni 11, 60121 Ancona, Italy.'}, {'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Polidori', 'Affiliation': 'Centro di Medicina della Riproduzione, Ospedale G. Salesi, Via F. Corridoni 11, 60123 Ancona, Italy.'}, {'ForeName': 'Fulvia Antonia', 'Initials': 'FA', 'LastName': 'Candela', 'Affiliation': 'Centro di Medicina della Riproduzione, Ospedale G. Salesi, Via F. Corridoni 11, 60123 Ancona, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vaccari', 'Affiliation': 'Elettra Sincrotrone Trieste, SISSI Beamline, 34149 Basovizza, Trieste, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cignitti', 'Affiliation': 'Clinica Ostetrica Ginecologica, Università Politecnica delle Marche, Ospedale G. Salesi, Via F. Corridoni 11, 60121 Ancona, Italy.'}, {'ForeName': 'Oliana', 'Initials': 'O', 'LastName': 'Carnevali', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, 60131 Ancona, Italy.'}]",International journal of molecular sciences,['10.3390/ijms21197124']
2882,32992531,Sarcopenia as a Mediator of the Effect of a Gerontogymnastics Program on Cardiorespiratory Fitness of Overweight and Obese Older Women: A Randomized Controlled Trial.,"The objectives were to analyze the effect of a gerontogymnastics program on functional ability and fitness on overweight and obese older woman and to understand if sarcopenia mediates its effect. This randomized controlled trial involved 216 overweight and obese women. The experimental group (EG) carried out 12 weeks of a gerontogymnastics program. The assessment was of gait speed, cardiorespiratory fitness, functional capacity, and muscle strength. EG showed significant improvements in almost every test. When the effect of training was adjusted by gait speed, the improvement of the 6 min walk test (MWT) for the trained group was no longer significant ( p  = 0.127). The improvement of the 6 MWT was significantly and positively associated with the 10 m test ( β  = -10.087). After including the 10-m test in the equations, the association between the 6MWT and carrying out the training program decreased but remained significant (β = -19.904). The mediation analysis showed a significant, direct and indirect effect with a significant Sobel test value ( z  = 6.606 ± 7.733;  p  = 0.000). These results indicate that a gerontogymnastics program improves functional capacity and fitness; and the effect of a gerontogymnastics program on CRF is mediated by sarcopenia in older women who are overweight and obese.",2020,The improvement of the 6 MWT was significantly and positively associated with the 10 m test ( β  = -10.087).,"['Overweight and Obese Older', 'older women who are overweight and obese', 'overweight and obese older woman', '216 overweight and obese women', 'Women']","['gerontogymnastics program', 'Gerontogymnastics Program']","['Cardiorespiratory Fitness', 'functional capacity and fitness', '6 MWT', 'gait speed, cardiorespiratory fitness, functional capacity, and muscle strength']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",216.0,0.0194839,The improvement of the 6 MWT was significantly and positively associated with the 10 m test ( β  = -10.087).,"[{'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Physical Activity and Sport Sciences Department, Faculty of Sport, Catholic University San Antonio of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Physical Activity and Sport Sciences Department, Faculty of Sport, Catholic University San Antonio of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Gemma María', 'Initials': 'GM', 'LastName': 'Gea-García', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Physical Activity and Sport Sciences Department, Faculty of Sport, Catholic University San Antonio of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'López-Vivancos', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Physical Activity and Sport Sciences Department, Faculty of Sport, Catholic University San Antonio of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Espeso-García', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Physical Activity and Sport Sciences Department, Faculty of Sport, Catholic University San Antonio of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gomes de Souza Vale', 'Affiliation': 'Active Aging, Exercise and Health/HEALTHY-AGE Network, Consejo Superior de Deportes (CSD), Ministry of Culture and Sport of Spain, 28040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17197064']
2883,32992570,"Comparison of Postural Sway, Plantar Cutaneous Sensation According to Saccadic Eye Movement Frequency in Young Adults.","The crossover trial study aimed to identify the saccadic eye movement (SEM) frequency to improve postural sway (PS) and plantar cutaneous sensation (PUS) in young adults. The 17 participants randomly performed 0.5-, 2-, and 3-Hz SEM. The SEM frequency was determined to allow the target to appear once per 2 s (0.5 Hz), twice per second (2 Hz), or thrice per second (3 Hz). SEM performance time was 3 min with a washout period of 5 min. PS and PUS were measured at baseline and during 0.5-Hz, 2-Hz, and 3-Hz SEMs using a Zebris FDM 1.5 force plate. PS was determined by measuring the sway area, path length, and speed of center of pressure (COP) displacement, and PUS was determined via the plantar surface area (PSA). In PS parameters, there was a significant difference among the SEM frequencies in the COP sway area  PSA left foot  and PSA right foot . Compared to that at baseline, COP sway area  decreased at 0.5 Hz and 2 Hz, while PSA left foot  and PSA right foot  increased at 2 Hz. These results suggest that 2 Hz SEM may improve PS and PSA.",2020,"Compared to that at baseline, COP sway area  decreased at 0.5 Hz and 2 Hz, while PSA left foot  and PSA right foot  increased at 2 Hz.","['Young Adults', 'young adults']",['saccadic eye movement (SEM) frequency'],"['SEM frequency', 'PS and PUS', 'COP sway area', 'PSA left foot  and PSA right foot', 'sway area, path length, and speed of center of pressure (COP) displacement, and PUS', 'SEM frequencies in the COP sway area  PSA left foot  and PSA right foot ', 'SEM performance time', 'Postural Sway, Plantar Cutaneous Sensation', 'PS and PSA', 'postural sway (PS) and plantar cutaneous sensation (PUS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0036019', 'cui_str': 'Saccadic eye movement'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0036019', 'cui_str': 'Saccadic eye movement'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0230460', 'cui_str': 'Structure of right foot'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",17.0,0.0259624,"Compared to that at baseline, COP sway area  decreased at 0.5 Hz and 2 Hz, while PSA left foot  and PSA right foot  increased at 2 Hz.","[{'ForeName': 'Youngsook', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Gachon University, 191 Hambangmoe-ro, Yeonsu-gu, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197067']
2884,32992726,Transcutaneous Vagus Nerve Stimulation Modulates EEG Microstates and Delta Activity in Healthy Subjects.,"Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders. The objective of this study is to assess the effects of tVNS on cerebral cortex activity in healthy volunteers using resting-state microstates and power spectrum electroencephalography (EEG) analysis. Eight male subjects aged 25-45 years were recruited in this randomized sham-controlled double-blind study with cross-over design. Real tVNS was administered at the left external acoustic meatus, while sham stimulation was performed at the left ear lobe, both of them for 60 min. The EEG recording lasted 5 min and was performed before and 60 min following the tVNS experimental session. We observed that real tVNS induced an increase in the metrics of microstate A mean duration ( p  = 0.039) and an increase in EEG power spectrum activity in the delta frequency band ( p  < 0.01). This study confirms that tVNS is an effective way to stimulate the vagus nerve, and the mechanisms of action of this activation can be successfully studied using scalp EEG quantitative metrics. Future studies are warranted to explore the clinical implications of these findings and to focus the research of the prognostic biomarkers of tVNS therapy for neuropsychiatric diseases.",2020,Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders.,"['Eight male subjects aged 25-45 years', 'healthy volunteers using resting-state microstates and power spectrum electroencephalography (EEG) analysis', 'Healthy Subjects']","['tVNS', 'Transcutaneous Vagus Nerve Stimulation Modulates EEG', 'Transcutaneous vagus nerve stimulation (tVNS']","['metrics of microstate A mean duration', 'cerebral cortex activity', 'EEG power spectrum activity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",8.0,0.0218572,Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Croce', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University of Chieti-Pescara, 66100 Chieti, Italy.""}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Lanzone', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Boscarino', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Zappasodi', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University of Chieti-Pescara, 66100 Chieti, Italy.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tombini', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Lazzaro', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Assenza', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}]",Brain sciences,['10.3390/brainsci10100668']
2885,32992759,CaRE @ Home: Pilot Study of an Online Multidimensional Cancer Rehabilitation and Exercise Program for Cancer Survivors.,"BACKGROUND


Although facility-based cancer rehabilitation and exercise programs exist, patients are often unable to attend due to distance, cost, and other competing obligations. There is a need for scalable remote interventions that can reach and serve a larger population.
METHODS


We conducted a mixed methods pilot study to assess the feasibility, acceptability and impact of CaRE@Home: an 8-week online multidimensional cancer rehabilitation and exercise program. Feasibility and acceptability data were captured by attendance and adherence metrics and through qualitative interviews. Preliminary estimates of the effects of CaRE@Home on patient-reported and physically measured outcomes were calculated.
RESULTS


A total of  n  = 35 participated in the study. Recruitment (64%), retention (83%), and adherence (80%) rates, along with qualitative findings, support the feasibility of the CaRE@Home intervention. Acceptability was also high, and participants provided useful feedback for program improvements. Disability (WHODAS 2.0) scores significantly decreased from baseline (T1) to immediately post-intervention (T2) and three months post-intervention (T3) ( p  = 0.03 and  p  = 0.008). Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p  = 0.007 and  p  = 0.0002) and moderate to strenuous LSI ( p  = 0.003 and  p  = 0.002) from baseline to T2 and T3. Work productivity (iPCQ) increased from T1 to T3 ( p  = 0.026). There was a significant increase in six minute walk distance from baseline to T2 and T3 ( p  < 0.001 and  p  = 0.010) and in grip strength from baseline to T2 and T3 ( p  = 0.003 and  p  < 0.001).
CONCLUSIONS


Results indicate that the CaRE@Home program is a feasible and acceptable cancer rehabilitation program that may help cancer survivors regain functional ability and decrease disability. In order to confirm these findings, a controlled trial is required.",2020,Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p  = 0.007 and  p  = 0.0002) and moderate to strenuous LSI ( p  = 0.003 and  p  = 0.002) from baseline to T2 and T3.,"['Cancer Survivors', 'A total of  n  = 35 participated in the study']","['CaRE@Home program', 'CaRE ', 'Online Multidimensional Cancer Rehabilitation and Exercise Program', 'CaRE@Home']","['six minute walk distance', 'Physical activity (GSLTPAQ) levels', 'Work productivity (iPCQ', 'Feasibility and acceptability data', 'moderate to strenuous LSI', 'grip strength', 'Acceptability', 'Disability (WHODAS 2.0) scores']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0691581,Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p  = 0.007 and  p  = 0.0002) and moderate to strenuous LSI ( p  = 0.003 and  p  = 0.002) from baseline to T2 and T3.,"[{'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'MacDonald', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Chafranskaia', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Lopez', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Maganti', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Bernstein', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'David Michael', 'Initials': 'DM', 'LastName': 'Langelier', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Edwards', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Bender', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shabbir Mh', 'Initials': 'SM', 'LastName': 'Alibhai', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103092']
2886,32992785,The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study.,"BACKGROUND


This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen.
METHODS


It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo).
RESULTS


A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test ( n  = 13) and control groups ( n  = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 ( t -test,  p  < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group.
CONCLUSIONS


In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.",2020,"Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque).","['Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL', 'Periodontitis in Vitamin-D-Deficient Patients', 'patients with initial 25(OH) vitamin D3', 'A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control']","['scaling and root planning (SRP', 'test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo', '6-Month Vitamin D Supplementation', 'placebo', 'vitamin D (VD) supplementation', 'Placebo']","['PPD', 'clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque', 'similar 25(OH) vitamin D3 levels', 'safe and efficacious']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",59.0,0.273972,"Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Perić', 'Affiliation': 'Department of Surgery, Medical, Molecular, and Critical Area, University of Pisa, 56126 Pisa, Italy.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Department of Endocrinology and Nutrition, Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cavalier', 'Affiliation': 'Department of Clinical Chemistry, CHU Sart-Tilman, University of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Jérôme F', 'Initials': 'JF', 'LastName': 'Lasserre', 'Affiliation': 'Service de Parodontologie, Ecole de Médecine Dentaire-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Toma', 'Affiliation': 'Service de Parodontologie, Ecole de Médecine Dentaire-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}]",Nutrients,['10.3390/nu12102940']
2887,32992801,Conjunctival Injection Reduction in Patients with Atopic Keratoconjunctivitis Due to Synergic Effect of Bovine Enteric-Coated Lactoferrin in 0.1% Tacrolimus Ophthalmic Suspension.,"Lactoferrin (LF), a multifunctional glycoprotein found in mammalian milk, is reported to have immunoregulatory effects. The present study aimed to evaluate whether enteric-coated LF (eLF) could improve symptoms in patients with atopic keratoconjunctivitis (AKC). This randomized double-blind placebo-controlled single-center trial comprised Japanese patients (n = 20; aged 22-60 years) with AKC. Patients treated with 0.1% tacrolimus ophthalmic suspension (TALYMUS ® ) were administered eLF (400 mg/d of bovine LF) or placebo tablets for 12 weeks. Conjunctival injection was examined, papillae formation in the palpebral conjunctiva was evaluated, and corneal fluorescein score, itchy sensation in end-point itching scale, and serum allergic parameters were assessed. Conjunctival injection was significantly reduced in the LF group than in the placebo group ( p  = 0.0017, Mann-Whitney U-test). Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p  = 0.010, unpaired T-test). LF combined with TALYMUS ®  could be a promising treatment strategy to mitigate AKC.",2020,"Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p  = 0.010, unpaired T-test).","['Patients with Atopic Keratoconjunctivitis', 'Japanese patients (n = 20; aged 22-60 years) with AKC', 'patients with atopic keratoconjunctivitis (AKC']","['eLF', 'Bovine Enteric-Coated Lactoferrin', 'Tacrolimus Ophthalmic Suspension', 'tacrolimus ophthalmic suspension (TALYMUS ® ', 'Lactoferrin (LF', 'LF combined with TALYMUS ®', 'placebo', 'enteric-coated LF (eLF']","['Conjunctival injection', 'Conjunctival Injection Reduction', 'corneal fluorescein score, itchy sensation in end-point itching scale, and serum allergic parameters', 'Papillae formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274788', 'cui_str': 'Atopic keratoconjunctivitis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0991532', 'cui_str': 'Eye suspension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",20.0,0.44871,"Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p  = 0.010, unpaired T-test).","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fujishima', 'Affiliation': 'Department of Ophthalmology, Tsurumi University School of Dental Medicine, Tsurumi, Yokohama 230-8501, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Department of Ophthalmology, Tsurumi University School of Dental Medicine, Tsurumi, Yokohama 230-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo 157-8535, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fukuda', 'Affiliation': 'Institute for Advanced Biosciences, Keio University, Tsuruoka, Yamagata 997-0052, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Institute for Advanced Biosciences, Keio University, Tsuruoka, Yamagata 997-0052, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9103093']
2888,32992830,Effects of a Multi-Ingredient Preworkout Supplement Versus Caffeine on Energy Expenditure and Feelings of Fatigue during Low-Intensity Treadmill Exercise in College-Aged Males.,"The primary purpose of this study was to examine the acute effects of a multi-ingredient (i.e., caffeine, green tea extract, Yohimbe extract, capsicum annum, coleus extract, L-carnitine, beta-alanine, tyrosine) preworkout supplement versus a dose of caffeine (6 mg·kg -1 ) on energy expenditure during low-intensity exercise. The effects of these treatments on substrate utilization, gas exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60 min of treadmill exercise on separate days after consuming a preworkout supplement, 6 mg·kg -1  of caffeine, or placebo in a randomized fashion. The preworkout and caffeine supplements resulted in significantly greater energy expenditure ( p  < 0.001,  p  = 0.006, respectively), V˙O 2  ( p  < 0.001,  p  = 0.007, respectively), V˙CO 2  ( p  = 0.006,  p  = 0.049, respectively), and V˙ E  ( p  < 0.001,  p  = 0.007, respectively) compared to placebo (collapsed across condition). There were no differences among conditions, however, for rates of fat or carbohydrate oxidation or respiratory exchange ratio. In addition, the preworkout supplement increased feelings of alertness ( p  = 0.015) and focus ( p  = 0.005) 30-min postingestion and decreased feelings of fatigue ( p  = 0.014) during exercise compared to placebo. Thus, the preworkout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg·kg -1  of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.",2020,"In addition, the preworkout supplement increased feelings of alertness ( p  = 0.015) and focus ( p  = 0.005) 30-min postingestion and decreased feelings of fatigue ( p  = 0.014) during exercise compared to placebo.","['Twelve males (mean ± SD: age = 22.8 ± 2.4 years', 'College-Aged Males']","['placebo', 'multi-ingredient (i.e., caffeine, green tea extract, Yohimbe extract, capsicum annum, coleus extract, L-carnitine, beta-alanine, tyrosine) preworkout supplement versus a dose of caffeine', 'Multi-Ingredient Preworkout Supplement Versus Caffeine', 'treadmill exercise on separate days after consuming a preworkout supplement, 6 mg·kg -1  of caffeine, or placebo']","['feelings of alertness', 'energy expenditure and measures of gas exchange', 'feelings of fatigue', 'substrate utilization, gas exchange, and psychological factors', 'Energy Expenditure and Feelings of Fatigue', 'rates of fat or carbohydrate oxidation or respiratory exchange ratio', 'energy expenditure', 'feelings of alertness and focus and decreased feelings of fatigue']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006932', 'cui_str': 'Capsicum'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0873094', 'cui_str': 'Coleus'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",12.0,0.128225,"In addition, the preworkout supplement increased feelings of alertness ( p  = 0.015) and focus ( p  = 0.005) 30-min postingestion and decreased feelings of fatigue ( p  = 0.014) during exercise compared to placebo.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lutsch', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Camic', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sports Medicine, Mayo Clinic Health System, Onalaska, WI 54650, USA.'}, {'ForeName': 'Riley R', 'Initials': 'RR', 'LastName': 'Stefan', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Cox', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Tauber', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Shaine E', 'Initials': 'SE', 'LastName': 'Henert', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100132']
2889,32992832,Bone Mineral Density in Severely Obese Women: Health Risk and Health Protective Risk Factors in Three Different Bone Sites.,"Factors associated with bone mineral density (BMD) are poorly known in severely obese individuals i.e., a body mass index (BMI) > 35 kg/m 2 . The objectives of this study were to describe the bone health profile of severely obese Brazilian women, to identify the health risk and health protective factors for BMD in this group and to assess whether these factors vary according to three different bone sites. BMD was assessed using dual-energy X-ray absorptiometry (DXA). This study analyzed baseline data from 104 women who had an average BMI of 43.7 ± 4.5 kg/m 2  and presented the following BMD status: 1.283 ± 0.094 g/cm 2  for total body, 1.062 ± 0.159 g/cm 2  for vertebral column and 1.195 ± 0.134 g/cm 2  for hip. They took part in the ""Effect of nutritional intervention and olive oil in severe obesity"" randomized clinical trial (DieTBra Trial). The risk factors negatively associated with lower BMD were age ≥50 years for the three bone sites i.e., total body, vertebral column and hip. Smoking for total body BMD ( p  = 0.045); BMI ≥ 50kg/m 2  for vertebral column and hip; menopause for hip; high C-reactive protein (CRP) levels ( p  = 0.049), insufficient zinc ( p  = 0.010) and previous fracture for vertebral column ( p  = 0.007). The protective factors positively associated with BMD were physical activity (≥150 min/week ( p  = 0.001)) for hip; type 2 diabetes mellitus (DM2) ( p  < 0.0001) total body and adequate vitamin D levels from food consumption ( p  = 0.039) for vertebral column. A BMI ≥ 50 kg/m 2  was a risk factor for lower BMD. The findings showed that protective and risk factors varied by bone site. The original study is registered with ClinicalTrials.gov. (protocol number: NCT02463435).",2020,The protective factors positively associated with BMD were physical activity (≥150 min/week ( p  = 0.001)) for hip; type 2 diabetes mellitus (DM2) ( p  < 0.0001) total body and adequate vitamin D levels from food consumption ( p  = 0.039) for vertebral column.,"['severely obese Brazilian women', 'Severely Obese Women', '104 women who had an average BMI of 43.7 ± 4.5 kg/m 2  and presented the following BMD status: 1.283 ± 0.094 g/cm 2  for total body, 1.062 ± 0.159 g/cm 2  for vertebral column and 1.195 ± 0.134 g/cm 2  for hip']",['nutritional intervention and olive oil'],"['bone mineral density (BMD', 'BMD were physical activity', 'total body and adequate vitamin D levels from food consumption', 'Health Risk and Health Protective Risk Factors', 'Bone Mineral Density', 'BMI ≥ 50kg/m 2  for vertebral column and hip; menopause for hip; high C-reactive protein (CRP) levels', 'BMD', 'total body BMD']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",104.0,0.0450941,The protective factors positively associated with BMD were physical activity (≥150 min/week ( p  = 0.001)) for hip; type 2 diabetes mellitus (DM2) ( p  < 0.0001) total body and adequate vitamin D levels from food consumption ( p  = 0.039) for vertebral column.,"[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Kellen de Souza Cardoso', 'Affiliation': 'Postgraduate Program in Health Sciences, Pontifical Catholic University of Goias, Goiânia 74605-020, Goiás, Brazil.'}, {'ForeName': 'Maria do Rosário', 'Initials': 'MDR', 'LastName': 'Gondim Peixoto', 'Affiliation': 'Postgraduate Program in Nutrition and Health, Faculty of Nutrition, Federal University of Goias, Goiânia 74605-220, Goiás, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Dos Santos Rodrigues', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goiás, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Rodrigues Mendonça', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goiás, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goiás, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17197017']
2890,32992943,The Effectiveness of Trunk Stabilization Exercise Combined with Vibration for Adolescent Patients with Nonspecific Low Back Pain.,"There are many adolescent patients complaining of low back pain, but research on it is lacking. The purpose of this study was to investigate the effects of trunk stabilization exercise combined with vibration on the pain, proprioception, and kinematics of the lumbar spine (LS) during sit to stand (STS) in adolescent patients with nonspecific low back pain (LBP). Fifty LBP patients were recruited and were randomly divided into two groups: Vibration group ( n  = 25) and placebo group ( n  = 25). All participants underwent 36-sessions of training consisting of six exercises. The Vibration group provided vibration stimulation during exercise, but the placebo group did not. The Numeric Pain Rating Scale (NPRS) and digital dual inclinometer were used to measure pain intensity and proprioception. The kinematics of the lumbar spine during STS were measured by motion capture system. After training, the pain and proprioception in the vibration group improved significantly greater than the placebo group ( p  < 0.05). The mobility of LS (maximum range of motion, angular velocity, lumbar to hip movement ratios) and lumbar-hip coordination during STS in the vibration group were significantly improved compared to the placebo group ( p  < 0.05). Thus, trunk stabilization exercise combined with vibration may be used to improve the pain, proprioception, and kinematic of the lumbar spine during sit to stand in adolescent patients with LBP.",2020,"After training, the pain and proprioception in the vibration group improved significantly greater than the placebo group ( p  < 0.05).","['adolescent patients with LBP', 'adolescent patients complaining of low back pain', 'Adolescent Patients with Nonspecific Low Back Pain', 'adolescent patients with nonspecific low back pain (LBP', 'Fifty LBP patients']","['Trunk Stabilization Exercise Combined with Vibration', 'Vibration group', 'trunk stabilization exercise combined with vibration', 'placebo', 'sit to stand (STS']","['Numeric Pain Rating Scale (NPRS) and digital dual inclinometer', 'pain and proprioception', 'pain, proprioception, and kinematic of the lumbar spine', 'vibration stimulation', 'pain intensity and proprioception', 'pain, proprioception, and kinematics of the lumbar spine (LS', 'mobility of LS (maximum range of motion, angular velocity, lumbar to hip movement ratios) and lumbar-hip coordination during STS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0436551', 'cui_str': 'C/O - low back pain'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",50.0,0.0246825,"After training, the pain and proprioception in the vibration group improved significantly greater than the placebo group ( p  < 0.05).","[{'ForeName': 'Kyoung-Sim', 'Initials': 'KS', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Jin-Hwa', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon 27136, Korea.'}, {'ForeName': 'Tae-Sung', 'Initials': 'TS', 'LastName': 'In', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Gachon University, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197024']
2891,32993116,Comparison between Gradual Reduced Nicotine Content and Usual Nicotine Content Groups on Subjective Cigarette Ratings in a Randomized Double-Blind Trial.,"In 2018, the United States Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking to reduce nicotine in tobacco products to produce a minimally addictive or nonaddictive effect, but there was a research gap in the subjective responses of reduced-nicotine-content cigarettes. We compared the responses of the modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS) between the gradually reduced nicotine content (RNC) group and the usual nicotine content (UNC) group. Linear mixed-effects models for repeated measures were used to analyze and compare the change over time for the mCEQ and CLS across the two treatment groups (RNC and UNC). We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette. At visits 8 and 9, the RNC group reported significantly lower satisfaction scores compared to UNC. Subscale analysis showed that smoking satisfaction decreased in RNC while other measures, such as cigarette enjoyment, did not change. Understanding the impact of nicotine reduction on cigarette subjective responses through evaluation and liking scales would provide valuable information to the FDA on nicotine reduction policies for cigarettes.",2020,We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette.,[],"['nicotine reduction', 'usual nicotine content (UNC']","['cigarette enjoyment', 'satisfaction scores', 'modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS', 'Subjective Cigarette Ratings', 'smoking satisfaction']",[],"[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.0180374,We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette.,"[{'ForeName': 'Wenxue', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA.'}, {'ForeName': 'Nicolle M', 'Initials': 'NM', 'LastName': 'Krebs', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA.'}, {'ForeName': 'Junjia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Horn', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech Carilion Research Institute, Roanoke, VA 24016, USA.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Muscat', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17197047']
2892,32993142,Impacts of a Standing Desk Intervention within an English Primary School Classroom: A Pilot Controlled Trial.,"Traditional classroom furniture dictates that children predominantly sit during class time. This study evaluated the impact of providing standing desks within a deprived UK primary school setting over 8 months using mixed-method approaches. All children within a Year 5 class (9-10-year-olds,  n  = 30) received an adjustable sit-stand desk, while another Year 5 class ( n  = 30) in a nearby school retained traditional furniture as a control classroom. At baseline, 4 months, and 8 months, activPAL monitors (PAL Technologies, Glasgow, UK) were worn for 7 days to provide time spent sitting and standing. Behavior-related mental health, musculoskeletal discomfort surveys, and a cognitive function test battery were also completed at all three timepoints. Intervention experiences from pupils and the teacher were captured using focus groups, interviews, and classroom observations. At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months -25.3% (-32.3, -18.4); 8 months -19.9% (-27.05, -12.9)). Qualitative data revealed challenges to teaching practicalities and a gradual decline in behavior-related mental health was observed (intervention vs. control: 4 months +5.31 (+2.55, +8.08); 8 months +7.92 (+5.18, +10.66)). Larger trials within similar high-priority settings are required to determine the feasibility and cost-effectiveness of providing standing desks to every child in the classroom.",2020,"At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months -25.3% (-32.3, -18.4); 8 months -19.9% (-27.05, -12.9)).","['All children within a Year 5 class (9-10-year-olds,  n  = 30) received an', 'English Primary School Classroom', 'children predominantly sit during class time']","['adjustable sit-stand desk, while another Year 5 class ( n  = 30) in a nearby school retained traditional furniture as a control classroom', 'Standing Desk Intervention']","['class time sitting', 'activPAL monitors (PAL Technologies, Glasgow, UK', 'behavior-related mental health']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0016858', 'cui_str': 'Furniture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0229275,"At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months -25.3% (-32.3, -18.4); 8 months -19.9% (-27.05, -12.9)).","[{'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3220, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Johnson', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Barber', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford BD9 6RJ, UK.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bingham', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford BD9 6RJ, UK.'}, {'ForeName': 'Liana C', 'Initials': 'LC', 'LastName': 'Nagy', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford OX3 0BP, UK.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17197048']
2893,32993175,Effects of Psychoactive Massage in Outpatients with Depressive Disorders: A Randomized Controlled Mixed-Methods Study.,"The clinical picture of depressive disorders is characterized by a plethora of somatic symptoms, psychomotor retardation, and, particularly, anhedonia. The number of patients with residual symptoms or treatment resistance is high. Touch is the basic communication among humans and animals. Its application professionally in the form of, e.g., psychoactive massage therapy, has been shown in the past to reduce the somatic and mental symptoms of depression and anxiety. Here, we investigated the effects of a specially developed affect-regulating massage therapy (ARMT) vs. individual treatment with a standardized relaxation procedure, progressive muscle relaxation (PMR), in 57 outpatients with depression. Patients were given one ARMT or PMR session weekly over 4 weeks. Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale. Furthermore, oral statements from all participants were obtained in semi-structured interviews. The findings show clear and statistically significant superiority of ARMT over PMR. The results might be interpreted within various models. The concept of interoception, as well as the principles of body psychotherapy and phenomenological aspects, offers cues for understanding the mechanisms involved. Within a neurobiological context, the significance of C-tactile afferents activated by special touch techniques and humoral changes such as increased oxytocin levels open additional ways of interpreting our findings.",2020,Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale.,"['57 outpatients with depression', 'Outpatients with Depressive Disorders']","['Psychoactive Massage', 'psychoactive massage therapy', 'regulating massage therapy (ARMT) vs. individual treatment with a standardized relaxation procedure, progressive muscle relaxation (PMR', 'ARMT or PMR']","['somatic and cognitive symptoms', 'standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025193', 'cui_str': 'Melancholia'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",57.0,0.0157459,Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale.,"[{'ForeName': 'Michaela Maria', 'Initials': 'MM', 'LastName': 'Arnold', 'Affiliation': 'Medizinische Fakultät, Julius-Maximilians-Universität Würzburg, 97070 Würzburg, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Müller-Oerlinghausen', 'Affiliation': 'Charité, Universitätsmedizin Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Hemrich', 'Affiliation': 'Berufsfachschule für Massage am Universitätsklinikum Würzburg, 97080 Würzburg, Germany.'}, {'ForeName': 'Dominikus', 'Initials': 'D', 'LastName': 'Bönsch', 'Affiliation': 'Medizinische Fakultät, Julius-Maximilians-Universität Würzburg, 97070 Würzburg, Germany.'}]",Brain sciences,['10.3390/brainsci10100676']
2894,32975853,"Increased lipolysis after infusion of acylated ghrelin, a randomized, double-blinded placebo-controlled trial in hypopituitary patients.","CONTEXT


Acylated ghrelin increases growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion from the anterior pituitary gland. Additionally, it increases free fatty acid levels independently of GH and ACTH, but the impact of ghrelin on fatty acid turnover has not been determined. This study was designed to test whether acylated ghrelin directly increases the turnover rate of fatty acids.
DESIGN


ight hypopituitary patients on stable replacement with GH and hydrocortisone were included in a randomized, double-blinded, placebo-controlled crossover study including two study days: 1) Infusion of acylated ghrelin and 2) Infusion of saline. The study day comprised a basal period (t=0-120 min) and a hyperinsulinemic euglycemic clamp period (t=120-300 min). Whole-body lipolysis was estimated at t=90-120 and t=270-300 min with a palmitate isotope dilution technique.
RESULTS


Infusion of acylated ghrelin resulted in 10 times increased total ghrelin area under the curve (AUC) levels in the basal period and 15 times increased AUC levels in the clamp period compared with saline infusion (p<0.001). GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15 % after ghrelin compared to saline infusion in the basal period (p=0.03). Palmitate turnover was increased by 43 % in the basal period (difference: 77 (20) µmol/min, p=0.01) and unchanged in the clamp period (difference 0.9 (17) µmol/min, p=1.0) after ghrelin compared to saline infusion.
CONCLUSIONS


Our results support the hypothesis that pharmacological levels of acylated ghrelin directly activates lipolysis at the whole-body level.",2020,"GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03).","['hypopituitary patients', 'Eight hypopituitary patients on stable replacement with GH and']","['hyperinsulinaemic-euglycemic clamp', 'placebo', 'hydrocortisone', 'infusion of acylated ghrelin and (b) infusion of saline']","['growth hormone (GH) and adrenocorticotrophic hormone', 'ACTH) secretion', 'free fatty acid levels', 'Palmitate turnover', 'cortisol AUC  levels', 'GH AUC  levels', 'Whole-body lipolysis', 'AUC levels', 'Increased lipolysis', 'turnover rate of fatty acids', 'total ghrelin area under the curve (AUC) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}]",8.0,0.273124,"GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03).","[{'ForeName': 'Esben Stistrup', 'Initials': 'ES', 'LastName': 'Lauritzen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}]",Clinical endocrinology,['10.1111/cen.14290']
2895,32971262,Another's pain in my brain: No evidence that placebo analgesia affects the sensory-discriminative component in empathy for pain.,"The shared representations account of empathy suggests that sharing other people's emotions relies on neural processes similar to those engaged when directly experiencing such emotions. Recent research corroborated this by showing that placebo analgesia induced for first-hand pain resulted in reduced pain empathy and decreased activation in shared neural networks. However, those studies did not report any placebo-related variation of somatosensory engagement during pain empathy. The experimental paradigms used in these studies did not direct attention towards a specific body part in pain, which may explain the absence of effects for somatosensation. The main objective of this preregistered study was to implement a paradigm overcoming this limitation, and to investigate whether placebo analgesia may also modulate the sensory-discriminative component of empathy for pain. We induced a localized, first-hand placebo analgesia effect in the right hand of 45 participants by means of a placebo gel and conditioning techniques, and compared this to the left hand as a control condition. Participants underwent a pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation. In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses. We thus report no evidence for somatosensory sharing in empathy, while replicating previous studies showing overlapping brain activity in the affective-motivational component for first-hand and empathy for pain. Hence, in a more rigorous test aiming to overcome limitations of previous work, we again find no causal evidence for the engagement of somatosensory sharing in empathy. Our study refines the understanding of the neural underpinnings of empathy for pain, and the use of placebo analgesia in investigating such models.",2020,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[""Another's pain in my brain"", '45 participants by means of a']","['placebo', 'pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation', 'placebo gel and conditioning techniques']","['behavioral nor neural responses', 'pain empathy']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",45.0,0.195586,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Riva', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117397']
2896,32972007,Effectiveness of  SaBang - DolGi  Walking Exercise Program on Physical and Mental Health of Menopausal Women.,"OBJECTIVE


We investigated the effectiveness of a 12-week SaBang-DolGi walking exercise program on the physical and mental health of menopausal women and aimed to provide the basic data needed to develop health promotion programs for the active and healthy aging of menopausal women.
MATERIALS AND METHODS


The participants comprised 40 women aged 50-65 years who were divided into two randomly selected groups in training sessions (exercising group, n = 21 and control group, n = 19). A physical (grip, muscle and endurance) test and mental health test (simple mental health test II) were conducted using questionnaires with the aim of examining subjects' physical and mental health before and after exercise.
RESULTS


After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains. Controlled and regular exercise for 12 weeks was significantly correlated with a positive change in vitality and mental health.
CONCLUSIONS


We found that the SaBang-DolGi walking exercise program helps to promote the physical and mental health of menopausal women who are exposed to the various stresses and depressions that accompany physical deterioration; the program was found to encourage active and healthy aging.",2020,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","['Menopausal Women', 'participants comprised 40 women aged 50-65 years', 'menopausal women']","['A physical (grip, muscle and endurance) test and mental health test (simple mental health test II', 'training sessions (exercising group', 'SaBang - DolGi  Walking Exercise Program', 'SaBang-DolGi walking exercise program']","['positive change in vitality and mental health', 'mental well-being and menopause-related health and subdomains', 'Physical and Mental Health']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",40.0,0.0282647,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","[{'ForeName': 'EunHee', 'Initials': 'E', 'LastName': 'Noh', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'JiYoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'MunHee', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Korea National Sport University, Seoul 05541, Korea.'}, {'ForeName': 'EunSurk', 'Initials': 'E', 'LastName': 'Yi', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186935']
2897,32972868,Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy.,"BACKGROUND


Adherence to positive airway pressure (PAP) therapies is poor, particularly among low-income populations and racial minorities. This study tested a low-resource, brief telephonic health coaching intervention to improve PAP adherence.
METHODS


Post hoc analysis of a quality improvement initiative in which English- and Spanish-speaking patients from a county-based public health system were randomly assigned to receive health coaching or usual care. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. A per-protocol analysis was conducted for adherence measures collected by device modem at baseline and 30 days.
RESULTS


Of 131 people for whom device data were available, 56 were randomized to health coaching and 75 to usual care. At baseline, 47.3% of patients had used their device at any time in the past 30 days, with a mean of 2 hours of use per night. At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
CONCLUSION


This pilot study suggests that a low-cost intervention could be effective at improving PAP adherence, even in a population known to have poor adherence and among long-term PAP users with poor adherence. Future research may examine whether a higher-touch intervention or one using videoconferencing yields greater improvements. This promising intervention warrants further study.",2020,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","['131 people for whom device data were available', 'English- and Spanish-speaking patients from a county-based public health system']","['health coaching and 75 to usual care', 'telephonic health coaching intervention', 'positive airway pressure (PAP) therapies', 'health coaching or usual care', 'Brief Health Coaching Intervention']",['PAP adherence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0681401,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Willard-Grace', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Eula', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.08.011']
2898,32973143,Neural correlates of mindful emotion regulation in high and low ruminators.,"Depressive rumination is considered a prominent risk factor for the occurrence, severity, and duration of depressive episodes. A variety of treatment options have been developed to treat depressive rumination of which mindfulness based programs are especially promising. In the current study, we investigated the neural underpinnings of a short mindfulness intervention and mindful emotion regulation in high and low trait ruminators in an ecologically valid environment using functional near-infrared spectroscopy (fNIRS). Participants were randomly assigned to a mindfulness instruction (MT) group or an instructed thinking (IT) group. Participants in the MT group were trained to either focus their attention mindfully on their breath or their emotions, while the IT group focused their attention on the past or future. Afterwards, all participants underwent an emotion regulation paradigm in which they either watched negative or neutral movie clips. During both paradigms cortical hemodynamic changes were assessed by means of fNIRS. Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition. Additionally, oxygenated hemoglobin in the MT group tended to be lower than in the IT group. Further, self-reports of emotional distress during the instruction paradigm were reduced in the MT group. During the emotion regulation paradigm, we observed reduced emotional reactivity in terms of emotional distress and avoidance in the MT group in comparison to the IT group. Furthermore, on a neural level, we observed higher CCN activity in the MT group in comparison to the IT group. We did not find any effect of rumination, neither on the intervention nor on the emotion regulation task. The results of this pilot study are discussed in light of the present literature on the neural correlates of mindfulness based interventions in rumination and emphasize the use of fNIRS to track neural changes in situ over the course of therapy.",2020,Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition.,[],"['mindfulness instruction (MT) group or an instructed thinking (IT', 'emotion regulation paradigm in which they either watched negative or neutral movie clips']","['emotional reactivity', 'emotional distress and avoidance', 'CCN activity', 'emotion regulation task', 'cognitive control network (CCN', 'Depressive rumination', 'oxygenated hemoglobin', 'emotional distress', 'lower activity']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0247818,Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany. david.rosenbaum@med.uni-tuebingen.de.'}, {'ForeName': 'Agnes M', 'Initials': 'AM', 'LastName': 'Kroczek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rubel', 'Affiliation': 'Psychotherapy Research Lab, Psychology and Sport Sciences, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Moritz J', 'Initials': 'MJ', 'LastName': 'Maier', 'Affiliation': 'Frauenhofer IAO | Center for Responsible Research and Innovation, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sorg', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Lucca', 'Initials': 'L', 'LastName': 'Weisbender', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Goldau', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Mennin', 'Affiliation': 'Hunter College, City University of New York, New York, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Ehlis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-020-71952-5']
2899,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION


A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES


and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS


46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23 mC to 22.4 mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION


It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
2900,32977380,Current Pharmacological Treatment Options for Central Serous Chorioretinopathy: A Review.,"Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina. Although CSC resolves spontaneously in most cases, in some patients it may cause permanent visual impairment in the working population; for this reason, several approaches, including photodynamic therapy (PDT), subthreshold micropulse laser treatment and oral mineralocorticoid receptor antagonists, have been studied as first-line treatment options for CSC. To date, half-dose PDT has provided the most encouraging results in this regard, supported by large, multicenter, randomized clinical trials such as the ""Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy"" (PLACE) trial; however, the role of novel possible non-invasive treatment options is attracting interest. This review article aims to discuss the current pharmacological treatment options investigated for the management of CSC, including aspirin, ketoconazole, beta blockers, rifampicin and many others. In particular, further evidence about oral mineralocorticoid receptor antagonists, firstly seen as promising non-invasive alternatives for treating CSC, will be provided and discussed in light of the recent ""Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months"" (VICI) trial results, which have largely resized their role as possible first-line oral treatment options for treating CSC.",2020,Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina.,"['Central Serous Chorioretinopathy', 'patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina', 'Central serous chorioretinopathy (CSC']","['aspirin, ketoconazole, beta blockers, rifampicin', 'photodynamic therapy (PDT']",[],"[{'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",[],,0.0451578,Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Nicolò', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Lorenzo Ferro', 'Initials': 'LF', 'LastName': 'Desideri', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Carlo Enrico', 'Initials': 'CE', 'LastName': 'Traverso', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13100264']
2901,32977404,An Exploratory Analysis of Changes in Mental Wellbeing Following Curcumin and Fish Oil Supplementation in Middle-Aged and Older Adults.,"Curcumin has previously been shown to enhance mood in non-depressed older adults. However, observed benefits were limited to short-term supplementation (4 weeks). In a 16 week randomized, double-blind, placebo-controlled, 2 × 2 factorial design trial, we supplemented overweight or obese non-depressed adults (50-80 years) with curcumin (160 mg/day), fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both. Secondary outcomes included mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL). Furthermore, plasma apolipoprotein E4 (APOE4) was measured to determine whether APOE4 status influences responses to fish oil. Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038). Fish oil did not affect any mood states, SMCs or QoL; however, responses to fish oil were affected by APOE4 status. In APOE4 non-carriers, fish oil increased vigour ( p  = 0.030) and reduced total mood disturbances ( p  = 0.048) compared to placebo. Improvements in mental wellbeing were correlated with increased QoL. Combining curcumin with fish oil did not result in additive effects. This exploratory analysis indicates that regular supplementation with either curcumin or fish oil (limited to APOE4 non-carriers) has the potential to improve some aspects of mental wellbeing in association with better QoL.",2020,Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038).,"['non-depressed older adults', 'supplemented overweight or obese non-depressed adults (50-80 years) with', 'Middle-Aged and Older Adults']","['Fish oil', 'curcumin', 'curcumin or fish oil', 'fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both', 'placebo', 'Curcumin and Fish Oil Supplementation']","['SMCs', 'total mood disturbances', 'Furthermore, plasma apolipoprotein E4 (APOE4', 'mental wellbeing', 'mood states, SMCs or QoL', 'Mental Wellbeing', 'additive effects', 'mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.371043,Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038).,"[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}]",Nutrients,['10.3390/nu12102902']
2902,32977459,Food Addiction Is Associated with Binge Eating and Psychiatric Distress among Post-Operative Bariatric Surgery Patients and May Improve in Response to Cognitive Behavioural Therapy.,"The current study examined clinical correlates of food addiction among post-operative bariatric surgery patients, compared the clinical characteristics of patients with versus without food addiction, and examined whether a brief telephone-based cognitive behavioural therapy (Tele-CBT) intervention improves food addiction symptomatology among those with food addiction. Participants ( N  = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery, were randomized to receive either Tele-CBT or standard bariatric post-operative care, and then, repeated the measure of food addiction at 1.25 and 1.5 years following surgery. Thirteen percent of patients exceeded the cut-off for food addiction at 1 year post-surgery, and this subgroup of patients reported greater binge eating characteristics and psychiatric distress compared to patients without food addiction. Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention. These preliminary findings suggest that Tele-CBT may be helpful, at least in the short term, in improving food addiction symptomatology among some patients who do not experience remission of food addiction following bariatric surgery; however, these findings require replication in a larger sample.",2020,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","['post-operative bariatric surgery patients', 'Participants ( N  = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery']","['telephone-based cognitive behavioural therapy (Tele-CBT) intervention', 'Tele-CBT or standard bariatric post-operative care']","['binge eating characteristics and psychiatric distress', 'Binge Eating and Psychiatric Distress', 'food addiction symptomatology']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]",,0.0444962,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Centre for Mental Health, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Hawa', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wnuk', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Bariatric Surgery Program, Toronto Western Hospital, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sockalingam', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}]",Nutrients,['10.3390/nu12102905']
2903,32977639,"Effect of a Nutrient-Rich, Food-Based Supplement Given to Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers.","Nutrient interventions initiated after conception tend to have modest effects on maternal nutritional status and pregnancy outcomes. Thus, we compared the association between micronutrient intakes and the trajectories of their biomarkers before and during pregnancy. Data from a randomized trial of the effect of a nutrient-rich, food-based supplement given to 317 Vietnamese women prior to or during pregnancy on birth outcomes were used to assess nutrient intakes with biomarker trajectories of zinc, iron, folate, cobalamin, and vitamin A using linear mixed regression models. The circulating plasma or serum trajectories of all five micronutrients were associated to their baseline levels ( p  < 0.0001). Plasma zinc trajectories were also related to farm work ( p  = 0.024). Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively). In this population of rural Vietnamese women, nutrient intakes during pregnancy did not affect biomarker trajectories. The primary determinant of each nutrient biomarker trajectory was its respective baseline level prior to conception.",2020,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively).","['rural Vietnamese women', '317 Vietnamese women prior to or during pregnancy on birth outcomes', 'Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers']","['nutrient-rich, food-based supplement', 'Nutrient-Rich, Food-Based Supplement Given']","['circulating plasma or serum trajectories', 'gestational weight gain', 'maternal nutritional status and pregnancy outcomes', 'Plasma zinc trajectories']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]",317.0,0.0269425,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively).","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Goletzke', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}]",Nutrients,['10.3390/nu12102913']
2904,32977820,"The therapeutic effects of methylphenidate and matrix-methylphenidate on addiction severity, craving, relapse and mental health in the methamphetamine use disorder.","BACKGROUND


Little evidence has examined the therapeutic effects of methylphenidate (MPH) and Matrix Model treatment on addiction severity, craving, relapse and mental health in people who use methamphetamine (PWUM). This study was conducted to determine the effects of MPH, Matrix Model treatment, and Matrix-MPH on addiction severity, craving, relapse and mental health in PWUM.
METHODS


This clinical trial was conducted among 100 patients with METH users. Participants were randomly divided into four groups who received: 1) 22 sessions of 45-min, twice a week for Matrix Model treatment (n = 25); 2) MPH 10 mg/day in the first month, 7.5 mg/day in the second month and 5 mg/day in the third month (n = 25); 3) Matrix Model treatment combined with MPH (n = 25); 4) control group (n = 25) for 12 weeks. Addiction severity, craving, relapse and mental status were evaluated at baseline and end-of-trial.
RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001). In addition, Matrix Model treatment combined with MPH resulted in a significant increase of mental health (P = 0.001), compared with Matrix Model treatment, MPH, and control group. Also, negative METH urine test significantly increased in the Matrix Model treatment combined with MPH group compared with the other groups (P < 0.001).
CONCLUSIONS


In conclusion, Matrix Model treatment combined with MPH for 12 weeks had beneficial effects on addiction severity, craving, relapse, and mental health in PWUM, compared with Matrix Model treatment, MPH, and control group.
TRIAL REGISTRATION


This study was retrospectively registered in the Iranian website ( www.irct.ir ) for clinical trials registration ( http://www.irct.ir : IRCT20171105037245N1 ). Registration date: 9 December 2017.",2020,"RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001).","['people who use methamphetamine (PWUM', '100 patients with METH users']","['methylphenidate and matrix-methylphenidate', 'Matrix Model treatment', 'Matrix Model treatment combined with MPH', 'methylphenidate (MPH) and Matrix Model treatment']","['addiction severity, craving, relapse, and mental health in PWUM', 'mental health', 'addiction severity', 'negative METH urine test', 'MA craving', 'addiction severity, craving, relapse and mental health', 'Addiction severity, craving, relapse and mental status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2188866', 'cui_str': 'History of methamphetamine abuse'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2188866', 'cui_str': 'History of methamphetamine abuse'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}]",100.0,0.0563746,"RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Aryan', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Shakeri', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sehat', 'Affiliation': 'Department of Community Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Mamsharifi', 'Affiliation': ""Department of Psychology, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Omidi', 'Affiliation': 'Department of clinical psychology, School of Medicine, Kashan University of Medical Science, Kashan, Iran. abomidi20@yahoo.com.'}]","Substance abuse treatment, prevention, and policy",['10.1186/s13011-020-00317-y']
2905,32978183,Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial.,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions ('Oral Health Toolbox') and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective.
METHODS AND ANALYSIS


A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the 'Oral Health Toolbox', a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial.
ETHICS AND DISSEMINATION


Ethical approval by the University of Kiel was granted (D480/18).
TRIAL REGISTRATION NUMBER


NCT04140929.",2020,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","['residents in German long-term residential care (LRC', '618 residents in 18 clusters']",[],"['OHrQL, daily oral hygiene/care behaviour', 'pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness', 'Oral health improvement', 'OHrQL, will be measured using the General Oral Health Assessment Index']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",618.0,0.135337,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Hertrampf', 'Affiliation': 'Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schlattmann', 'Affiliation': 'Medical Statistics, Computer and DataSciences, Friedrich-Schiller-Universitat Jena, Jena, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gassmann', 'Affiliation': 'praxisHochschule pHfG Trägergesellschaft, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hammen', 'Affiliation': 'praxisHochschule University of Applied Sciences, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Zahnerhaltung, Charite Universitatsmediz in Berlin Campus Benjamin Franklin, Berlin, Germany falk.schwendicke@charite.de.'}]",BMJ open,['10.1136/bmjopen-2019-035999']
2906,32978185,Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes.,"INTRODUCTION


Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to.
METHODS AND ANALYSIS


The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient's ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.
ETHICS AND DISSEMINATION


This protocol was approved by the ethics committee of the Charité-Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03671447).",2020,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","['elderly patients with chronic diseases being treated in the intensive care unit (ICU', '1431 patients', '12 academic hospitals in Berlin and Brandenburg, Germany']","['multifactorial training programme', 'critical care telehealth program']","['process quality and functional outcomes', 'health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211071,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adrion', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Busse', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Marschall', 'Affiliation': 'BARMER, Wuppertal, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Caumanns', 'Affiliation': 'Fraunhofer Institute for Open Communication Systems, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rosseau', 'Affiliation': 'Weaning and Ventilation Centre, Ernst von Bergmann Klinikum, Bad Belzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany claudia.spies@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036096']
2907,32978188,Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial.,"INTRODUCTION


Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.
METHODS AND ANALYSIS


This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.
ETHICS AND DISSEMINATION


The study has been approved by the Ethical Committee of the Guang'anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.
TRIAL REGISTRATION


NCT04185259.",2020,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"['120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1', 'patients with chronic plantar fasciitis', 'patients suffering from chronic PF']","['Acupuncture', '30\u2009min acupuncture or SA', 'acupuncture versus sham acupuncture', 'acupuncture and sham acupuncture (SA', 'acupuncture']","['worst pain intensity', 'treatment response rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",120.0,0.197437,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Guizhou University of Traditional Chinese Medicine, Guiyang City, Guizhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zang', 'Affiliation': 'Department of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, China.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, China Academy of Chinese Medical Sciences Guanganmen Hospital, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China zhishunjournal@163.com.""}]",BMJ open,['10.1136/bmjopen-2020-036773']
2908,32978193,Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educational trial.,"INTRODUCTION


The quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.
METHODS AND ANALYSIS


We will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only).
ETHICS, REGISTRATION AND DISSEMINATION


National research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.
TRIAL REGISTRATION NUMBER


ISRCTN20431944.",2020,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","['junior postgraduate orthopaedic surgeons-in-training', 'postgraduate trauma and orthopaedic surgical trainees', 'postgraduate orthopaedic surgeons-in-training in the first 3\u2009years (of 8) of the specialist training programme']","[""cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures"", 'cadaveric simulation training intervention versus standard training', 'Cadaveric simulation versus standard training', 'cadaveric training', 'cadaveric simulation training']","['procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only', 'technical success of the surgery performed on patients by the participating surgeons-in-training', 'postoperative radiograph']","[{'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0524852', 'cui_str': 'Orthopaedic procedure'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",,0.0994631,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'James', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK h.smith.1@warwick.ac.uk.'}, {'ForeName': 'Giles T R', 'Initials': 'GTR', 'LastName': 'Pattison', 'Affiliation': 'Trauma & Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Fisher', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037319']
2909,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2020,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Diagnostic Imaging, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
2910,32996139,Regular antenatal exercise including pelvic floor muscle training reduces urinary incontinence 3 months postpartum-Follow up of a randomized controlled trial.,"INTRODUCTION


Urinary incontinence is a frequently reported condition among women with pregnancy and delivery as established risk factors. The aims of this study were to evaluate the effect of an antenatal exercise program including pelvic floor muscle training on postpartum urinary incontinence, and to explore factors associated with urinary incontinence three months postpartum.
MATERIAL AND METHODS


This is a short-term follow-up and secondary analysis of a randomized controlled trial conducted at two Norwegian University Hospitals including healthy, pregnant women aged >18 years with a singleton live fetus. Women in the exercise group received a 12-week standardized exercise program including pelvic floor muscle training, with once weekly group exercise classes led by a physiotherapist and twice weekly home exercise sessions. The controls received standard antenatal care. Data were obtained from questionnaires answered in pregnancy weeks 18-22, and three months postpartum. Urinary incontinence prevalence in the exercise and control groups was compared, and multivariable logistic regression analyses were applied. Urinary incontinence prevalence three months postpartum was assessed by the Sandvik severity index.
RESULTS


Among the 722 (84%) women who responded three months postpartum, significantly fewer women in the exercise group (29%) reported urinary incontinence compared with the standard antenatal care group (38%, P = .01). Among women who were incontinent at baseline, 44% and 59% (P = .014) were incontinent at three months postpartum in the exercise and control groups, respectively. Urinary incontinence three months postpartum was associated with age (OR 1.1, 95% CI 1.0-1.1), experiencing urinary incontinence in late pregnancy (OR 3.6, 95% CI 2.3-5.9), birthweight ≥4000 g (OR 1.8, 95% CI 1.2-2.8), and obstetric anal sphincter injuries (OR 2.6, 95% CI 1.1-6.1). Cesarean section significantly reduced the risk of urinary incontinence three months postpartum compared with spontaneous vaginal delivery (OR 0.2, 95% CI 0.1-0.5).
CONCLUSIONS


A moderate-intensity exercise program including pelvic floor muscle training reduced prevalence of urinary incontinence 3 months postpartum in women who were incontinent at baseline.",2020,A moderate intensity exercise program including pelvic floor muscle training reduced prevalence of urinary incontinence three months postpartum in women who were incontinent at baseline.,"['two Norwegian University Hospitals including healthy, pregnant women >18 years with a singleton live fetus', 'urinary incontinence three months postpartum in women who were incontinent at baseline']","['moderate intensity exercise program including pelvic floor muscle training', 'standardized exercise program including pelvic floor muscle training, with once weekly group exercise classes led by a physiotherapist and twice weekly home exercise sessions', 'Regular antenatal exercise including pelvic floor muscle training', 'antenatal exercise program including pelvic floor muscle training', 'standard antenatal care']","['Urinary incontinence three months postpartum', 'risk of urinary incontinence', 'Urinary incontinence prevalence', 'experiencing urinary incontinence in late pregnancy', 'urinary incontinence', 'obstetric anal sphincter injuries', 'postpartum urinary incontinence']","[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231238', 'cui_str': 'Incontinent'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0419126', 'cui_str': 'Antenatal exercises'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}]",,0.0812945,A moderate intensity exercise program including pelvic floor muscle training reduced prevalence of urinary incontinence three months postpartum in women who were incontinent at baseline.,"[{'ForeName': 'Hege H', 'Initials': 'HH', 'LastName': 'Johannessen', 'Affiliation': 'Department of Health and Welfare, Østfold University College, Fredrikstad, Norway.'}, {'ForeName': 'Betina E', 'Initials': 'BE', 'LastName': 'Frøshaug', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pernille J G', 'Initials': 'PJG', 'LastName': 'Lysåker', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Kjell Å', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': ""Department of Obstetrics and Gynecology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Signe N', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14010']
2911,32996885,Impact of a Blended Periconception Lifestyle Care Approach on Lifestyle Behaviors: Before-and-After Study.,"BACKGROUND


Periconception lifestyle behaviors affect maternal, paternal, offspring, and transgenerational health outcomes. Previous research in other target populations has shown that personalized lifestyle interventions, in which face-to-face counseling and eHealth (""blended care"") are combined, may effectively target these lifestyle behaviors.
OBJECTIVE


We aimed to assess the effectiveness of a periconceptional lifestyle intervention on the improvement of specific lifestyle components.
METHODS


A blended periconception lifestyle care approach was developed, combining the outpatient lifestyle counseling service ""Healthy Pregnancy"" with the eHealth platform ""Smarter Pregnancy"" (www.smarterpregnancy.co.uk) in which lifestyle was coached for 24 weeks. All couples contemplating pregnancy or already pregnant (≤12 weeks of gestation) who visited the outpatient clinics of the Department of Obstetrics and Gynecology at the Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands, between June and December 2018, were invited to participate. We measured changes in lifestyle behaviors at weeks 12 and 24 compared with baseline. Generalized estimating equations were used to analyze the changes in lifestyle behaviors over time. Subgroup analyses were performed for women with obesity (BMI ≥30 kg/m 2 ), women pregnant at the start of the intervention, and those participating as a couple.
RESULTS


A total of 539 women were screened for eligibility, and 450 women and 61 men received the blended periconception intervention. Among the participating women, 58.4% (263/450) were included in the preconception period. Moreover, 78.9% (403/511) of the included participants completed the online lifestyle coaching. At baseline, at least one poor lifestyle behavior was present in most women (379/450, 84.2%) and men (58/61, 95.1%). In the total group, median fruit intake increased from 1.8 to 2.2 pieces/day (P<.001) and median vegetable intake increased from 151 to 165 grams/day (P<.001) after 24 weeks of online coaching. The probability of taking folic acid supplementation among women increased from 0.97 to 1 (P<.001), and the probability of consuming alcohol and using tobacco in the total group decreased from 0.25 to 0.19 (P=.002) and from 0.20 to 0.15 (P=.63), respectively. Overall, the program showed the strongest effectiveness for participating couples. Particularly for vegetable and fruit intake, their consumption increased from 158 grams/day and 1.8 pieces/day at baseline to 190 grams/day and 2.7 pieces/day at the end of the intervention, respectively.
CONCLUSIONS


We succeeded in including most participating women in the preconception period. A high compliance rate was achieved and users demonstrated improvements in several lifestyle components. The blended periconception lifestyle care approach seems to be an effective method to improve lifestyle behaviors. The next step is to further disseminate this approach and to perform a randomized trial to compare the use of blended care with the provision of only eHealth. Additionally, the clinical relevance of these results will need to be substantiated further.",2020,"The probability of taking folic acid supplementation among women increased from 0.97 to 1 (P<.001), and the probability of consuming alcohol and using tobacco in the total group decreased from 0.25 to 0.19 (P=.002) and from 0.20 to 0.15 (P=.63), respectively.","['539 women were screened for eligibility, and 450 women and 61 men received the', 'All couples contemplating pregnancy or already pregnant (≤12 weeks of gestation) who visited the outpatient clinics of the Department of Obstetrics and Gynecology at the Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands, between June and December 2018, were invited to participate', 'women with obesity (BMI ≥30 kg/m 2 ), women pregnant at the start of the intervention, and those participating as a couple', 'participating women, 58.4% (263/450) were included in the preconception period', 'participating women in the preconception period', 'Lifestyle Behaviors']","['Blended Periconception Lifestyle Care Approach', 'periconceptional lifestyle intervention', 'outpatient lifestyle counseling service ""Healthy Pregnancy"" with the eHealth platform ""Smarter Pregnancy"" (www.smarterpregnancy.co.uk', 'blended periconception intervention']","['probability of consuming alcohol and using tobacco', 'lifestyle behaviors', 'median vegetable intake', 'median fruit intake', 'probability of taking folic acid supplementation', 'lifestyle behavior', 'several lifestyle components']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",539.0,0.0353467,"The probability of taking folic acid supplementation among women increased from 0.97 to 1 (P<.001), and the probability of consuming alcohol and using tobacco in the total group decreased from 0.25 to 0.19 (P=.002) and from 0.20 to 0.15 (P=.63), respectively.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'van der Windt', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Rianne Maria', 'Initials': 'RM', 'LastName': 'van der Kleij', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Katinka Marianne', 'Initials': 'KM', 'LastName': 'Snoek', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sten Paul', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ramon Henny Maria', 'Initials': 'RHM', 'LastName': 'Dykgraaf', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Joop Stephanus Elisabeth', 'Initials': 'JSE', 'LastName': 'Laven', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Schoenmakers', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Régine Patricia Maria', 'Initials': 'RPM', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/19378']
2912,32996886,One-Way and Two-Way Mobile Phone Text Messages for Treatment Adherence Among Patients With HIV: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings.
OBJECTIVE


This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life).
METHODS


A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5.
RESULTS


Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging-based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life).
CONCLUSIONS


The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging-based intervention and its impact on adherence to ART.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16127.",2020,"We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life).
","['participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon', '246 participants', 'patients with HIV on ART', 'Patients With HIV', 'patients with HIV and on associated clinical outcomes (quality of life', 'Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207']","['one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care', 'SMS', 'antiretroviral therapy (ART']",['adherence and quality of life'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",246.0,0.198379,"We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life).
","[{'ForeName': 'Dickson Shey', 'Initials': 'DS', 'LastName': 'Nsagha', 'Affiliation': 'Department of Public Health and Hygiene, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Vincent Verla', 'Initials': 'VV', 'LastName': 'Siysi', 'Affiliation': 'Department of Medicine, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Same', 'Initials': 'S', 'LastName': 'Ekobo', 'Affiliation': 'Department of Public Health and Hygiene, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Thomas Obinchemti', 'Initials': 'TO', 'LastName': 'Egbe', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Odette Dzemo', 'Initials': 'OD', 'LastName': 'Kibu', 'Affiliation': 'Department of Public Health and Hygiene, University of Buea, Buea, Cameroon.'}]",JMIR research protocols,['10.2196/16127']
2913,32997421,Symptom-orientated oral hygiene for children after heart transplantation: Effectiveness of a standardized prophylactic program.,"Children with CHD, especially heart-transplanted patients, are predisposed to have caries lesions, gingivitis and other oral findings like gingival hyperplasia. The aim of the study was the implementation of a specific oral hygiene program in these patients and its effect on the improvement of oral health, especially gingival overgrowth. For this, we used a newly developed systematic GHI to evaluate and describe this gingival alteration. Thirty-three children, aged 6 to 15 years with cardiac transplants (9 girls, 24 boys), were examined and introduced into a specific oral hygiene program. Each child showed evidence of gingival hyperplasia. They were randomly divided into three groups with the following oral care measurements: Group ZZ tooth brushing, Group ZZS tooth brushing and mouth rinsing, Group ZZSS tooth brushing, mouth rinsing and the use of an additional single and sulcus toothbrush. A significant decline of all oral health parameters could be proven in all groups. Gingival hyperplasia (GHI) improved as well as plaque accumulation (QHI). The children who used in addition to toothbrushing rinsing solutions and/or additional miniature toothbrushes showed better parameters of the gingival hygiene indexes from the baseline examination until the end of the study. The results show that any infant with cardiac transplant has to be introduced into an individualized oral hygiene program underlining the need of comprehensive dental care in cooperation with pediatric cardiology.",2020,Gingival hyperplasia (GHI) improved as well as plaque accumulation (QHI).,"['children after heart transplantation', 'Children with CHD, especially heart-transplanted patients', 'Thirty-three children, aged 6 to 15\xa0years with cardiac transplants (9 girls, 24 boys']","['standardized prophylactic program', 'oral care measurements: Group ZZ tooth brushing, Group ZZS tooth brushing and mouth rinsing, Group ZZSS tooth brushing, mouth rinsing and the use of an additional single and sulcus toothbrush']","['gingival hyperplasia', 'Gingival hyperplasia (GHI', 'oral health, especially gingival overgrowth', 'oral health parameters', 'gingival hygiene indexes', 'plaque accumulation (QHI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0017566', 'cui_str': 'Hyperplasia of gingiva'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",33.0,0.0193741,Gingival hyperplasia (GHI) improved as well as plaque accumulation (QHI).,"[{'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Schulz-Weidner', 'Affiliation': 'Department of Pediatric Dentistry, Medical Centre of Odontology, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Bulski', 'Affiliation': 'Department of Pediatric Dentistry, Medical Centre of Odontology, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Rachida', 'Initials': 'R', 'LastName': 'Siahi-Benlarbi', 'Affiliation': 'Department of Pediatric Dentistry, Medical Centre of Odontology, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bauer', 'Affiliation': 'Pediatric Heart Centre, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Thushiha', 'Initials': 'T', 'LastName': 'Logeswaran', 'Affiliation': 'Pediatric Heart Centre, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jux', 'Affiliation': 'Pediatric Heart Centre, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Willi-Eckhard', 'Initials': 'WE', 'LastName': 'Wetzel', 'Affiliation': 'Department of Pediatric Dentistry, Medical Centre of Odontology, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Krämer', 'Affiliation': 'Department of Pediatric Dentistry, Medical Centre of Odontology, Justus Liebig University, Giessen, Germany.'}]",Pediatric transplantation,['10.1111/petr.13845']
2914,32993832,Implementing a package of noncommunicable disease interventions in the Republic of Moldova: two-year follow-up data.,"Noncommunicable diseases (NCDs) are a growing challenge in the Republic of Moldova. A previously reported pilot cluster randomized controlled trial aimed to determine the feasibility of implementing and evaluating essential interventions for NCDs (e.g. cardiovascular risk scoring, hypertension management, statin treatment, etc.) in primary health care in the Republic of Moldova, with a view toward national scale up. One-year follow-up data (previously published) demonstrated modest improvements in NCD risk factor identification and management could be achieved. Herein, we report the second-year follow-up data and conclude that sustainable improvements in NCD risk factor control (e.g. hypertension control) can be achieved in primary health care in low resource settings by adapting existing resources (e.g. WHO PEN) and conducting focused clinical training and support. If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",2020,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",[],[],[],[],[],[],,0.0278124,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Inglin', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Ghenadie', 'Initials': 'G', 'LastName': 'Curocichin', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Salaru', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zatic', 'Affiliation': 'Primary, Emergency and Community Health Policies Department, Ministry of Health, Labour and Social Protection, Chisinau, Republic of Moldova.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Anisei', 'Affiliation': 'Department on Quality Management of Health Services, National Public Health Agency, Chisinau, Republic of Moldova.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chiosa', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Munteanu', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Zinaida', 'Initials': 'Z', 'LastName': 'Alexa', 'Affiliation': 'Endocrinology Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",Primary health care research & development,['10.1017/S1463423620000420']
2915,32994159,"Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories:  Post Hoc  Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial.","BACKGROUND AND OBJECTIVES


In the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome), empagliflozin, in addition to standard of care, significantly reduced risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and incident or worsening nephropathy by 39% compared with placebo in patients with type 2 diabetes and established cardiovascular disease. Using EMPA-REG Outcome data, we assessed whether the Kidney Disease Improving Global Outcomes (KDIGO) CKD classification had an influence on the treatment effect of empagliflozin.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Patients with type 2 diabetes, established atherosclerotic cardiovascular disease, and eGFR≥30 ml/min per 1.73 m 2  at screening were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care.  Post hoc , we analyzed cardiovascular and kidney outcomes, and safety, using the two-dimensional KDIGO classification framework.
RESULTS


Of 6952 patients with baseline eGFR and urinary albumin-creatinine ratio values, 47%, 29%, 15%, and 8% were classified into low, moderately increased, high, and very high KDIGO risk categories, respectively. Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60). In all KDIGO risk categories, placebo and empagliflozin had similar adverse event rates, the notable exception being genital infection events, which were more common with empagliflozin for each category.
CONCLUSIONS


The observed effects of empagliflozin versus placebo on cardiovascular and kidney outcomes were consistent across the KDIGO risk categories, indicating that the effect of treatment benefit of empagliflozin was unaffected by baseline CKD status.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


EMPA-REG OUTCOME, NCT01131676.",2020,Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60).,"['Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome', 'Patients with type 2 diabetes, established atherosclerotic cardiovascular disease, and eGFR≥30 ml/min per 1.73 m 2  at screening', '6952 patients with']","['empagliflozin', 'placebo and empagliflozin', 'empagliflozin 10 mg, empagliflozin 25 mg, or placebo', 'placebo', 'Empagliflozin', 'Placebo']","['adverse event rates', 'Kidney Disease Improving Global Outcomes (KDIGO', 'risk of cardiovascular death', 'cardiovascular and kidney outcomes, and safety', 'hospitalization for heart failure', 'baseline eGFR and urinary albumin-creatinine ratio values', 'kidney outcomes', 'cardiovascular and kidney outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6952.0,0.578353,Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60).,"[{'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, Canada alevin@providencehealth.bc.ca.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.14901219']
2916,32994239,"Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial.","INTRODUCTION


Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotising pancreatitis (ANP). Therefore, the prevention of IPN is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of ANP will result in a reduced incidence of IPN.
METHODS AND ANALYSIS


This is a randomised, multicentre, double-blind, placebo-controlled study. 520 eligible patients with ANP will be randomised in a 1:1 ratio to receive either the thymosin alpha 1 or the placebo using the same mode of administration. The primary endpoint is the incidence of IPN during the index admission. Most of the secondary endpoints will be registered within the index admission including in-hospital mortality, the incidence of new-onset organ failure and new-onset persistent organ failure (respiration, cardiovascular and renal), receipt of new organ support therapy, requirement for drainage or necrosectomy, bleeding requiring intervention, human leucocyte antigens-DR(HLA-DR) on day 0, day 7, day 14, and so on and adverse events. Considering the possibility of readmission, an additional follow-up will be arranged 90 days after enrolment, and IPN and death at day 90 will also be served as secondary outcomes.
ETHICS AND DISSEMINATION


This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02). The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT02473406).",2020,The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP.,"['520 eligible patients with ANP', 'patients with acute necrotising pancreatitis (ANP', 'Jinling Hospital, Nanjing University (Number 2015NZKY-004-02']","['thymosin alpha 1 or the placebo', 'placebo']","['incidence of IPN during the index admission', 'index admission including in-hospital mortality, the incidence of new-onset organ failure and new-onset persistent organ failure (respiration, cardiovascular and renal), receipt of new organ support therapy, requirement for drainage or necrosectomy, bleeding requiring intervention, human leucocyte antigens-DR(HLA-DR']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0076612', 'cui_str': 'thymalfasin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341479', 'cui_str': 'Infected pancreatic necrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4761057', 'cui_str': 'Necrosectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",520.0,0.490509,The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wenjian', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China kkb9832@gmail.com.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Xinting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, China.'}, {'ForeName': 'Chengjian', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Nanhua Hospital, University of South China, Hengyang, Hunan, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Intensive care Unit, Nantong City No 1 People's Hospital and Second Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.""}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Intensive Care Unit, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China.'}, {'ForeName': 'Jingchun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Intensive Care Unit, 94th Hospital of PLA, Nanchang, Jiangxi, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Emergency, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Tu', 'Affiliation': ""Department of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Intensive Care Unit, Luoyang Center Hospital, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Guoxiu', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Henan University of Science and Technology Affiliated First Hospital, Luoyang, Henan, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Yangzhou University Affiliated Northern Jiangsu People's Hospital, Yangzhou City, Jiangsu Province, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': ""Department of Emergency Intensive Care Unit, Shangqiu First People's Hospital, Shangqiu, Henan, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Qilu Hospital of Shandong University Qingdao, Qingdao, Shandong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Intensive Care Unit, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037231']
2917,32994242,Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients.,"INTRODUCTION


As the population ages, there is interest in strategies to promote resiliency, especially for frail patients at risk of its complications. The physiological stress of surgery in high-risk individuals has been proposed both as an important cause of accelerated age-related decline in health and as a model testing the effectiveness of strategies to improve resiliency to age-related health decline. We describe a randomised, embedded, multifactorial, adaptative platform (REMAP) trial to investigate multiple perioperative interventions, the first of which is metformin and selected for its anti-inflammatory and anti-ageing properties beyond its traditional blood glucose control features.
METHODS AND ANALYSIS


Within a multihospital, single healthcare system, the Core Protocol for Strategies to Promote ResiliencY (SPRY) will be embedded within both the electronic health record (EHR) and the healthcare culture generating a continuously self-learning healthcare system. Embedding reduces the administrative burden of a traditional trial while accessing and rapidly analysing routine patient care EHR data. SPRY-Metformin is a placebo-controlled trial and is the first SPRY domain evaluating the effectiveness of three metformin dosages across three preoperative durations within a heterogeneous set of major surgical procedures. The primary outcome is 90-day hospital-free days. Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection. Using response adaptative randomisation, a maximum of 2500 patients allows 77%-92% power, detecting >15% primary outcome improvement. Secondary outcomes include mortality, readmission and postoperative complications. A subset of patients will be selected for substudies evaluating the microbiome, cognition, postoperative delirium and strength.
ETHICS AND DISSEMINATION


The Core Protocol of SPRY REMAP and associated SPRY-Metformin Domain-Specific Appendix have been ethically approved by the Institutional Review Board and are publicly registered. Results will be publicly available to healthcare providers, patients and trial participants following achieving predetermined platform conclusions.
TRIAL REGISTRATION NUMBER


NCT03861767.",2020,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"['frail patients at risk of its complications', 'high-risk patients']","['Metformin', 'SPRY']","['mortality, readmission and postoperative complications', '90-day hospital-free days']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2500.0,0.142159,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"[{'ForeName': 'Katherine Moll', 'Initials': 'KM', 'LastName': 'Reitz', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA reitzkm2@upmc.edu.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Seymour', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vates', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Quintana', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Morowitz', 'Affiliation': ""Department of Surgery, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Methe', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Girard', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar C', 'Initials': 'OC', 'LastName': 'Marroquin', 'Affiliation': 'Clinical Analytics, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Anesthesiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Holder-Murray', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037690']
2918,32994251,Evaluation of the efficacy of low concentration fluoride gel using custom trays to prevent radiation-related dental caries in patients with head and neck cancer: protocol for a randomised controlled phase III trial (FluCar study).,"INTRODUCTION


The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
METHODS AND ANALYSIS


Patients will be randomised into fluoride and control groups (1:1 ratio). In the fluoride group, patients will wear custom trays loaded with 0.145% fluoride gel after brushing every night while sleeping. In the control group, patients will receive oral hygiene instructions as usual. Patients in both the groups will be followed up every 3 months for 1 year. The primary endpoint is the incidence of newly developed dental caries. Target accrual is 80 patients with a two-sided type I error rate of 5% and 80% power to detect 80% risk reduction.
ETHICS AND DISSEMINATION


This study was approved by the Clinical Research Review Board in Nagasaki University The protocol of this study was registered at Japan Registry of Clinical Trials (jRCT) and University hospital Medical Information Network Clinical Trials Registry (UMIN). The datasets generated during the current study will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBERS: jRCTs 072190039 and UMIN000041426.",2020,"The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
","['patients with head and neck cancer', 'Nagasaki University', '80 patients with a two-sided type I error rate of 5% and 80% power to detect 80% risk reduction', 'patients with head and neck cancer who have undergone or are undergoing radiotherapy']","['fluoride gel', 'fluoride', 'low concentration fluoride gel', 'fluoride gel, applied using custom trays']",['incidence of newly developed dental caries'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",,0.100873,"The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
","[{'ForeName': 'Soutome', 'Initials': 'S', 'LastName': 'Sakiko', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Yanamoto', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan syana@nagasaki-u.ac.jp.'}, {'ForeName': 'Maho', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kawashita', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Yoshimatsu', 'Affiliation': 'Oral Care Center, Nagasaki Daigaku Byoin, Nagasaki, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Funahara', 'Affiliation': 'School of Oral Health, Kyushu Shika Daigaku, Kitakyushu, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-038606']
2919,32976869,Phase 1 trial of ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide in the treatment of newly diagnosed glioblastoma.,"BACKGROUND AND PURPOSE


This phase 1 trial aimed to determine the maximum tolerated dose (MTD; primary objective) of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients.
MATERIALS AND METHODS


The study was designed as an open-label dose-escalation study driven by a Tite-CRM design and followed by an expansion cohort. Ralimetinib was administered orally every 12 h, 7 days a week, for 2 cycles of 2 weeks at a dose of 100, 200 or 300 mg/12 h. Patients received ralimetinib added to standard concurrent RT (60 Gy in 30 fractions) with TMZ (75 mg/m 2 /day) and 6 cycles of adjuvant TMZ (150-200 mg/m 2  on days 1-5 every 28 days).
RESULTS


The MTD of ralimetinib was 100 mg/12 h with chemoradiotherapy. The three patients treated at 200 mg/12 h presented a dose-limiting toxicity: one patient had a grade 3 face edema, and two patients had a grade 3 rash and grade 3 hepatic cytolysis (66%). Of the 18 enrolled patients, 15 received the MTD of ralimetinib. At the MTD, the grade ≥ 3 adverse events during concomitant chemoradiotherapy were hepatic cytolysis (2/15 patients), dermatitis/rash (1/15), lymphopenia (1/15) and nausea/vomiting (1/15). No interaction of TMZ and ralimetinib when administrated concomitantly has been observed. Inhibition of pMAPKAP-K2 (-54%) was observed in peripheral blood mononuclear cells.
CONCLUSION


This phase 1 trial is the first trial to study the combination of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients. The MTD of ralimetinib was 100 mg/12 h. The most frequent dose-limiting toxicities were hepatic cytolysis and rash.",2020,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"['18 enrolled patients, 15 received the MTD of ralimetinib', 'newly diagnosed glioblastoma', 'newly diagnosed glioblastoma (GBM) patients']","['adjuvant TMZ', 'TMZ', 'ralimetinib added to standard concurrent RT', 'Ralimetinib', 'p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ', 'ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide']","['peripheral blood mononuclear cells', 'lymphopenia (1/15) and nausea/vomiting', 'dermatitis/rash', 'grade 3 rash and grade 3 hepatic cytolysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0257535', 'cui_str': 'CSAID-Binding Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}]",18.0,0.0623238,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Radiation Department, Centre Jean Perrin, Clermont-Ferrand, France; University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France. Electronic address: Julian.biau@clermont.unicancer.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thivat', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chautard', 'Affiliation': 'University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; Department of Clinical Research, Délégation Recherche Clinique et Innovation, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stefan', 'Affiliation': 'Pathology Department, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boone', 'Affiliation': 'Radiation Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'Radiation Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bourgne', 'Affiliation': 'Department of Medical Oncology, CHU Amiens, Amiens Cedex 1, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Richard', 'Affiliation': 'Department of Biologic Hematology, CHU Estaing, Clermont-Ferrand Cedex 1, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Molna', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Levesque', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bellini', 'Affiliation': 'CHU Clermont-Ferrand, University of Clermont-Auvergne, Medical Pharmacology Department, UMR INSERM, 1107 Neuro-Dol, Clermont-Ferrand, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Karayan-Tapon', 'Affiliation': 'Radiodiagnostic Department, Centre Jean-Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verrelle', 'Affiliation': 'Radiation Department, Centre Jean Perrin, Clermont-Ferrand, France; University of Poitiers, INSERMU1084, CHU de Poitiers, Department of Cancer Biology, Poitiers, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Godfraind', 'Affiliation': 'Department of Radiation Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Durando', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France; Department of Pathological Anatomy, CHU de Clermont-Ferrand, Clermont-Ferrand, France.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.036']
2920,32977661,Acute Effects of Aerobic Exercise on Somatosensory-Evoked Potentials in Patients with Mild Cognitive Impairment.,"Mild cognitive impairment (MCI) is becoming a serious problem for developing countries as the lifespan of populations increases. Exercise is known to be clinically beneficial for MCI patients. Somatosensory-evoked potentials (SEPs) may be a potential diagnostic and prognostic marker for this population. The objective of this study was to determine the acute effects of aerobic exercise on SEPs in patients with MCI, to test whether SEPs are sensitive enough to detect improvements in early somatosensory processing. The study had a randomized parallel-group design and included 28 MCI subjects (14 in the experimental group and 14 in the control group). The experimental intervention was 20 min of aerobic exercise using a stationary bicycle. The control intervention involved 20 min of movements and stretches. Subjects were assessed before and after a single intervention session. SEPs were recorded by stimulating the median nerve of the dominant hand. Analysis of normalized SEP peak amplitudes showed that a single session of aerobic activity significantly reduced the N30 peak at the F3 channel ( p  = 0.03). There were no significant effects of aerobic exercise on SEP peak latencies. The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients. The results suggest that aerobic exercise is likely to provide sensory-enriching inputs that enhance sensorimotor integration. Future studies should assess the effects of aerobic exercise on somatosensory processing in progressive stages of Alzheimer's disease, longer exercise durations, and multiple exercise sessions.",2020,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"['patients with MCI', 'Patients with Mild Cognitive Impairment', 'Mild cognitive impairment (MCI', '28 MCI subjects (14 in the experimental group and 14 in the control group']","['aerobic exercise using a stationary bicycle', 'Aerobic Exercise', 'aerobic exercise', 'Somatosensory-evoked potentials (SEPs']","['N30 SEP peak amplitude', 'SEP peak latencies', 'normalized SEP peak amplitudes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",28.0,0.0984768,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Amjad', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Hamza Ghazanfar', 'Initials': 'HG', 'LastName': 'Toor', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shafique', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Touqeer', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}]",Brain sciences,['10.3390/brainsci10100663']
2921,32977683,"The Effectiveness of Narrative Versus Didactic Information Formats on Pregnant Women's Knowledge, Risk Perception, Self-Efficacy, and Information Seeking Related to Climate Change Health Risks.","Climate change is a global threat that poses significant risks to pregnant women and to their developing fetus and newborn. Educating pregnant women about the risks to their pregnancy may improve maternal and child health outcomes. Prior research suggests that presenting health information in narrative format can be more effective than a didactic format. Hence, the purpose of this study was to test the effectiveness of two brief educational interventions in a diverse group of pregnant women ( n  = 151). Specifically, using a post-test only randomized experiment, we compared the effectiveness of brief information presented in a narrative format versus a didactic format; both information formats were also compared to a no information control group. Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior. As hypothesized, for all outcome measures, the narrative format was more effective than the didactic format. These results suggest the benefits of a narrative approach (versus a didactic approach) to educating pregnant women about the maternal and child health threats posed by climate change. This study adds to a growing literature on the effectiveness of narrative-based approaches to health communication.",2020,"Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior.","[""Pregnant Women's"", 'Educating pregnant women', 'diverse group of pregnant women ( n  = 151']","['Narrative Versus Didactic Information Formats', 'narrative approach (versus a didactic approach', 'educational interventions']","[""pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior"", 'Knowledge, Risk Perception, Self-Efficacy, and Information Seeking']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0596775', 'cui_str': 'Information Seeking Behavior'}]",,0.0267453,"Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior.","[{'ForeName': 'Adebanke L', 'Initials': 'AL', 'LastName': 'Adebayo', 'Affiliation': 'Department at George Mason University, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Davidson Mhonde', 'Affiliation': 'Department at George Mason University, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'DeNicola', 'Affiliation': 'School of Medicine and Health Sciences, The George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Maibach', 'Affiliation': 'Center for Climate Change Communication, George Mason University, Fairfax, VA 22030, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17196969']
2922,32977684,Nutrition Education Intervention Increases Fish Consumption among School Children in Indonesia: Results from Behavioral Based Randomized Control Trial.,"This study aimed to analyze the effectiveness of behavioral-based nutrition education to increase fish consumption among school children using a raised bed pool. This was a randomized control trial study with a 3-months nutrition education intervention using a raised bed pool, as a medium to improve their internalization to increase fish consumption behavior. A paired  t -test was used to calculate the difference in the increase of fish consumption, knowledge, attitude, perceived behavioral control, subjective norm, and intention. This study took place in a majority of low to medium urban households in Surabaya in Sidotopo Wetan I and Sidotopo Wetan II elementary school. Elementary school children at 4th and 5th grade and mother of elementary school children with 104 children were eligible and willing to participate. After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001). The 3 months of nutrition education intervention based on the theory of planned behavior significantly increase fish consumption among elementary school children. The increased consumption was believed to be related to the increase in children's knowledge and attitude towards consuming fish.",2020,"After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001).","['Elementary school children at 4th and 5th grade and mother of elementary school children with 104 children were eligible and willing to participate', 'School Children in Indonesia', 'elementary school children', 'school children using a raised bed pool', 'majority of low to medium urban households in Surabaya in Sidotopo Wetan']","['Nutrition Education Intervention', 'nutrition education intervention', '3-months nutrition education intervention', 'behavioral-based nutrition education']","['delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption', 'fish consumption, knowledge, attitude, perceived behavioral control, subjective norm, and intention']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",104.0,0.0209479,"After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001).","[{'ForeName': 'Trias', 'Initials': 'T', 'LastName': 'Mahmudiono', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Triska Susila', 'Initials': 'TS', 'LastName': 'Nindya', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Qonita', 'Initials': 'Q', 'LastName': 'Rachmah', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Calista', 'Initials': 'C', 'LastName': 'Segalita', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Luh Ade Ari', 'Initials': 'LAA', 'LastName': 'Wiradnyani', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEO RECFON) Pusat Kajian Gizi Regional (PKGR), Universitas Indonesia, Jl. Salemba Raya No.6, Jakarta Pusat 10430, Indonesia.'}]",International journal of environmental research and public health,['10.3390/ijerph17196970']
2923,32977710,Food Consumption and Emotions at a Salad Lunch Buffet in a Multisensory Environment.,"The food experience is multisensory and multisensory external stimuli may affect food choice and emotions. The objective of this study was to evaluate the effect of a multisensory eating environment on food choice, intake and the emotional states of the subjects in a salad lunch buffet setting. A total of 30 female subjects consumed a salad lunch twice in the multisensory laboratory. The two test conditions (control and multisensory condition with environmental stimuli) were randomized and the visits were scheduled one week apart. Subjects selected and ate a meal from a salad buffet including 14 food items and the intake of each item was weighed. They answered an online questionnaire about the meal and their emotional states (20 different emotion terms) after the lunch. There was no significant difference in the food consumption between the control and multisensory conditions. The subjects were very satisfied with their lunch for both study visits but the pleasantness of the eating environment was rated higher under the multisensory condition. In emotional terms, the subjects selected the term ""happy"" significantly more frequently under the multisensory condition compared with the control. In conclusion, the multisensory eating environment in this study was not related to food intake but may be associated with positive emotions. The effect of the eating environment on food choice and experience deserves further study with a larger study population in a real lunch restaurant setting.",2020,There was no significant difference in the food consumption between the control and multisensory conditions.,"['subjects in a salad lunch buffet setting', '30 female subjects consumed a salad lunch twice in the multisensory laboratory']","['eating environment', 'multisensory eating environment']","['food consumption', 'Food Consumption and Emotions']","[{'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0313404,There was no significant difference in the food consumption between the control and multisensory conditions.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Hoppu', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Puputti', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Saila', 'Initials': 'S', 'LastName': 'Mattila', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Puurtinen', 'Affiliation': 'Department of Teacher Education, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sandell', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101349']
2924,32978182,Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial.,"INTRODUCTION


Neuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.
METHODS AND ANALYSIS


This is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).
ETHICS AND DISSEMINATION


This protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT04163666).",2020,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"['154 patients who had a stroke aged above 18 years', 'patients with severe hemiparesis after a stroke']","['home-based mirror therapy and cognitive therapeutic exercise', 'Mirror therapy (MT) and cognitive therapeutic exercise (CTE', 'MT and the other one on CTE, both combined with task-oriented training', 'MT and CTE, combined with task-oriented training']","['cognitive performance, emotional state, quality of life and activities of daily living', 'functionality of the affected upper extremity measured using the Fugl-Meyer Assessment']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",154.0,0.129301,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"[{'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Gonzalez-Santos', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Soto-Camara', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain rscamara@ubu.es.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodriguez-Fernández', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jimenez-Barrios', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Gonzalez-Bernal', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Collazo-Riobo', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Jahouh', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bravo-Anguiano', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Trejo-Gabriel-Galan', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-035768']
2925,32978194,Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial.,"INTRODUCTION


Stroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.
METHODS AND ANALYSIS


We will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12-18 months from a hospital in southeastern China.
ETHICS AND DISSEMINATION


The study was approved by the Human Research Ethics Committee from the corresponding author's hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.
TRIAL REGISTRATION NUMBER


NCT03702452.",2020,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","['patients with stroke often suffer from functional impairments and need rehabilitation', 'patients with acute ischaemic stroke', 'patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load', '224 patients within a period of 12-18\u2009months from a hospital in southeastern China', 'acute ischaemic stroke']","['usual rehabilitation provided by therapists', 'Rehabilitation nursing', 'rehabilitation nursing by trained and qualified nurses']","['Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test', 'modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",224.0,0.142712,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","[{'ForeName': 'Jianmiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Neurology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jingfen', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China zrjzkhl@zju.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037391']
2926,32978200,"Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study.","INTRODUCTION


Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy.
METHOD AND ANALYSIS


MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance <30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04045093); pre-results.",2020,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","['686 participants', 'patients with AF with underlying moderate or severe mitral stenosis (MS', 'patients with non-valvular atrial fibrillation (AF', 'AF patients with moderate or severe MS', 'Patients with estimated creatinine clearance <30\u2009mL/min, or with a concomitant indication for antiplatelet therapy will be excluded', 'MoDerate or Severe Mitral Stenosis (DAVID-MS', 'Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months']","['vitamin K oral anticoagulants (NOACs', 'DAbigatran', 'dabigatran 110\u2009mg or 150\u2009mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design', 'dabigatran']","['ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death', 'safety and efficacy', 'composite of stroke and systemic embolism']","[{'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C1273051', 'cui_str': 'Estimated creatinine clearance'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.205221,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","[{'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacology and Pharmacy, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jo Jo', 'Initials': 'JJ', 'LastName': 'Hai', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Ka', 'Initials': 'CK', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yuk Ming', 'Initials': 'YM', 'LastName': 'Lau', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cheung Chi', 'Initials': 'CC', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chor Cheung Frankie', 'Initials': 'CCF', 'LastName': 'Tam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yiu Tung Anthony', 'Initials': 'YTA', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'See Yue Arthur', 'Initials': 'SYA', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ki Wan Kelvin', 'Initials': 'KWK', 'LastName': 'Chan', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chi Yui', 'Initials': 'CY', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kwok Lun', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Wai', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Hong', 'Initials': 'MH', 'LastName': 'Jim', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kai Hang', 'Initials': 'KH', 'LastName': 'Yiu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Yan', 'Affiliation': 'Cardiology Division, Department of Medicine & Therapeutics, Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chung Wah', 'Initials': 'CW', 'LastName': 'Siu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China cwdsiu@hku.hk.'}]",BMJ open,['10.1136/bmjopen-2020-038194']
2927,32978204,Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial.,"INTRODUCTION


Studies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.
METHODS AND ANALYSIS


This two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.
ETHICS AND DISSEMINATION


Investigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).
TRIAL REGISTRATION NUMBER


NCT04154059.",2020,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"['individuals with KOA', 'patients with knee osteoarthritis (KOA', 'diabetic patients', 'people with knee osteoarthritis', '88 patients with medial tibiofemoral osteoarthritis']","['therapeutic foot-ankle exercise programme', 'control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme', 'foot-ankle strengthening programme']","['clinical aspects and gait biomechanics', 'patellofemoral pain', 'pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC', 'WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake', 'pain, functionality, foot strength, foot kinematics and knee joint overload during gait']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",88.0,0.0910656,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"[{'ForeName': 'Glauko', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'Dos Santos', 'Affiliation': 'UNA University Center, Pouso Alegre, Brazil.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Watari', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Paula R M S', 'Initials': 'PRMS', 'LastName': 'Serrao', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Pott-Junior', 'Affiliation': 'Department of Medicine, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2020-039279']
2928,32978836,A novel virtual reality-based theory of mind intervention for outpatients with schizophrenia: A proof-of-concept pilot study.,"Schizophrenia is a severe and highly disabling mental illness. Although several pharmacological solutions are available to alleviate symptoms of schizophrenia, they do not seem to provide solution for accompanying social dysfunctions. To handle this unmet clinical need, many innovative interventions have been developed recently. Considering the promising results on this field and the development trend, characterized by the growing proportion of included interactive technology, our research team developed a novel virtual reality (VR)-based targeted theory of mind (ToM) intervention (VR-ToMIS) for stable outpatients with schizophrenia. VR-ToMIS is a nine-session long structured and individualized method that uses cognitive and behavioural therapeutic techniques in an immersive VR environment. Our study was a randomized, controlled pilot study. Twenty-one patients have been recruited and randomly allocated to either VR-ToMIS or passive VR condition. Patients assigned to passive VR condition could use the same VR software as the VR-ToMIS group, but without any interventions. Effects on psychiatric symptoms, neurocognitive and social cognitive functions, pragmatic language skills and quality of life were evaluated by using analysis of covariance. According to our results, VR-ToMIS was associated with improvements in negative symptoms, in one neurocognitive field (immediate memory), ToM and pragmatic language skills, but no significant change in quality of life scores was detected. Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24-.46, φ = .55-.67). On the background of the presented pilot results, VR-ToMIS is concluded to be feasible and tolerable.",2020,"Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24 - .46, φ=.55 - .67).","['stable outpatients with schizophrenia', 'outpatients with schizophrenia']","['novel virtual reality (VR) based targeted Theory of Mind (ToM) intervention (VR-ToMIS', 'novel virtual reality-based Theory of Mind intervention', 'VR-ToMIS or passive-VR condition']","['Quality of Life scores', 'negative symptoms, in one neurocognitive field (immediate memory), Theory of Mind and pragmatic language skills', 'psychiatric symptoms, neurocognitive- and social cognitive functions, pragmatic language skills and quality of life']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",21.0,0.0147767,"Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24 - .46, φ=.55 - .67).","[{'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Vass', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Viktória', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Zita', 'Initials': 'Z', 'LastName': 'Fekete', 'Affiliation': 'Institute of Behavioral Sciences, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lencse', 'Affiliation': 'Faculty of Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Ecseri', 'Affiliation': 'Faculty of Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Kis', 'Affiliation': 'Department of Psychiatry, Szabolcs Szatmár Bereg County Hospitals and University Teaching Hospital, Nyíregyháza, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Semmelweis University, Budapest, Hungary.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2519']
2929,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
2930,32984784,"An open-label, randomized trial of the combination of IFN-κ plus TFF2 with standard care in the treatment of patients with moderate COVID-19.","Background


Epidemic outbreaks caused by SARS-CoV-2 are worsening around the world, and there are no target drugs to treat COVID-19. IFN-κ inhibits the replication of SARS-CoV-2; and TFF2 is a small secreted polypeptide that promotes the repair of mucosal injury and reduces the inflammatory responses. We used the synergistic effect of both proteins to treat COVID-19.
Methods


We conducted an open-label, randomized, clinical trial involving patients with moderate COVID-19. Patients were assigned in a 1:1 ratio to receive either aerosol inhalation treatment with IFN-κ and TFF2 every 24 h for six consecutive dosages in addition to standard care (experimental group) or standard care alone (control group). The primary endpoint was the time until a viral RNA negative conversion for SARS-CoV-2 in all clinical samples. The secondary clinical endpoint was the time of CT imaging improvement. Data analysis was performed per protocol. This study was registered with chictr.org.cn, ChiCTR2000030262.
Findings


Between March 23 and May 23 of 2020, 86 COVID-19 patients with symptoms of moderate illness were recruited, and 6 patients were excluded due to not matching the inclusion criteria (patients with pneumonia through chest radiography). Among the remaining 80 patients, 40 patients were assigned to experimental group, and the others were assigned to control group to only receive standard care. Efficacy and safety were evaluated for both groups. The time of viral RNA negative conversion in experimental group (Mean, 3·80 days, 95% CI 2·07-5·53), was significantly shorter than that in control group (7·40 days, 95% CI 4·57 to 10·23) ( p  = 0.031), and difference between means was 3·60 days. The percentage of patients in experimental group with reversion to negative viral RNA was significantly increased compared with control group on all sampling days (every day during the 12-day observation period) ( p  = 0·037). For the secondary endpoint, the experimental group had a significantly shorter time until improvement was seen by CT (Mean 6·21 days,  N  = 38/40, 95% CI 5·11-7·31) than that in control group (8·76 days,  N  = 34/40, 95% CI 7·57-9·96) ( p  = 0.002), and difference between means was 2·55 days. No discomfort or complications during aerosol inhalation were reported to the nurses by any experimental patients.
Interpretation


In conclusion, we found that aerosol inhalation of IFN-κ plus TFF2 in combination with standard care is safe and superior to standard care alone in shortening the time up to viral RNA negative conversion in all clinical samples. In addition, the patients in experimental group had a significantly shortened CT imaging improvement time than those in control group. This study suggested that this combination treatment is able to facilitate clinical improvement (negative for virus, improvement by CT, reduced hospitalization stay) and thereby result in an early release from the hospital. These data support the need for exploration with a large-scale trial of IFN-κ plus TFF2 to treat COVID-19.
Funding


Funding was provided by the National Natural Science Foundation of China, National Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.",2020,"38/40, 95% CI 5·11-7·31) than that in control group","['patients with moderate COVID-19', 'Findings\n\n\nBetween March 23 and May 23 of 2020, 86 COVID-19 patients with symptoms of moderate illness were recruited, and 6 patients were excluded due to not matching the inclusion criteria (patients with pneumonia through chest radiography']","['aerosol inhalation treatment with IFN-κ and TFF2 every 24\xa0h for six consecutive dosages in addition to standard care (experimental group) or standard care alone (control group', 'IFN-κ', 'control group to only receive standard care', 'IFN-κ plus TFF2']","['time of viral RNA negative conversion', 'discomfort or complications', 'shorter time until improvement', 'time of CT imaging improvement', 'negative viral RNA', 'Efficacy and safety', 'CT imaging improvement time', 'hospitalization stay', 'time until a viral RNA negative conversion for SARS-CoV-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",40.0,0.0571901,"38/40, 95% CI 5·11-7·31) than that in control group","[{'ForeName': 'Weihui', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Huiliang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zha', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Fengru', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Shang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Longfei', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100547']
2931,32985509,Comparative effects of virtual reality training and sensory motor training on bone morphogenic proteins and inflammatory biomarkers in post-traumatic osteoarthritis.,"The objective of this study is to compare the effects of virtual reality training (VRT) and sensory-motor training (SMT) in bone morphogenetic proteins (BMP) and inflammatory biomarkers expression in post-traumatic osteoarthritis (PTOA) after the anterior cruciate ligament injury. Through a simple random sampling method, 60 eligible participants were allocated into VRT (n = 20), SMT (n = 20), and control groups (n = 20). They underwent training programs for 4 weeks. Clinical (pain intensity and functional disability) and biochemical (bone morphogenic proteins and inflammatory biomarkers) values were measured at baseline, after 4 weeks, 8 weeks and 3 months follow up. Four weeks following training, the VRT group shows more significant changes in pain intensity and functional disability than SMT and control groups (P < 0.001). Bone morphogenic protein (BMP) measures such as BMP 2, 4, 6, and 7 don't show any significant changes between the groups. But at the same time, the VRT group shows positive improvement in inflammatory biomarkers (CRP, TNF-α, IL-2, IL-4, IL-6) analysis than the other two groups (P < 0.001). Our study suggests that including virtual reality training in PTOA shows beneficial changes in pain, functional disability, and modification of inflammatory biomarkers than sensory-motor training, but at the same time it shows a negligible effect on bone morphogenic proteins.",2020,"Four weeks following training, the VRT group shows more significant changes in pain intensity and functional disability than SMT and control groups (P < 0.001).","['post-traumatic osteoarthritis', 'post-traumatic osteoarthritis (PTOA) after the anterior cruciate ligament injury', '60 eligible participants']","['SMT', 'virtual reality training and sensory motor training', 'virtual reality training (VRT) and sensory-motor training (SMT', 'VRT']","['pain intensity and functional disability', 'Clinical (pain intensity and functional disability) and biochemical (bone morphogenic proteins and inflammatory biomarkers) values', 'bone morphogenic proteins and inflammatory biomarkers', 'inflammatory biomarkers (CRP, TNF-α, IL-2, IL-4, IL-6) analysis', 'pain, functional disability, and modification of inflammatory biomarkers']","[{'cui': 'C2894027', 'cui_str': 'Post traumatic osteoarthritis'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0450131', 'cui_str': 'Bone morphogenic protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.0363602,"Four weeks following training, the VRT group shows more significant changes in pain intensity and functional disability than SMT and control groups (P < 0.001).","[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia. physio_gopal@rediffmail.com.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Khalil', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Saud F', 'Initials': 'SF', 'LastName': 'Alsubaie', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Scientific reports,['10.1038/s41598-020-72587-2']
2932,32985539,A randomised trial evaluating the effect of intraoperative iron administration.,"Perioperative anaemia increases postoperative morbidity and mortality, and iron deficiency is anaemia's most common cause in surgical patients. Preoperative intravenous iron increases postoperative haemoglobin; however, data regarding intraoperative intravenous iron's effectiveness are inadequate. This study examined intraoperative intravenous iron's effects on postoperative haemoglobin levels in adults. Fifty-seven healthy subjects (aged 19-40 years) scheduled for bimaxillary orthognathic surgery were assigned randomly to the iron (n = 28) or control (n = 29) groups. The iron group received intravenous ferric derisomaltose (1,000 mg) after anaesthetic induction. The control group received an identical volume of intravenous normal saline. The primary outcome was postoperative haemoglobin level. Secondary outcomes included other postoperative haematologic and iron parameters. Laboratory data were obtained preoperatively and at 1 day, 2 weeks, and 4 weeks postoperatively. Haemoglobin was higher in the iron group 2 weeks postoperatively (12.9 g/dL vs. 12.2 g/dL), but the between-group difference was not significant after adjustment for multiple testing. However, the reticulocyte production index was significantly higher in the iron group 2 weeks postoperatively. Intraoperative intravenous iron maintains postoperative haemoglobin values in patients undergoing bimaxillary orthognathic surgery by increasing haematopoietic function and iron bioavailability and therefore appears to be a useful strategy for blood management.",2020,Haemoglobin was higher in the iron group 2 weeks postoperatively,"['adults', 'patients undergoing bimaxillary orthognathic surgery', 'surgical patients', 'Fifty-seven healthy subjects (aged 19-40\xa0years) scheduled for bimaxillary orthognathic surgery']","['intravenous ferric derisomaltose', 'intraoperative iron administration', 'intravenous normal saline']","['haematopoietic function and iron bioavailability', 'postoperative haematologic and iron parameters', 'postoperative haemoglobin', 'reticulocyte production index', 'postoperative haemoglobin levels', 'postoperative haemoglobin level', 'Haemoglobin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035286', 'cui_str': 'Reticulocyte'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",57.0,0.468864,Haemoglobin was higher in the iron group 2 weeks postoperatively,"[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Severance Hospital and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Severance Hospital and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Laboratory Medicine, Yonsei University College of Medicine, Yonsei-ro 50-1, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Young-Soo', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, College of Dentistry, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. YSJOMS@yuhs.ac.'}, {'ForeName': 'Bon-Nyeo', 'Initials': 'BN', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Severance Hospital and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. KOOBN@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-020-72827-5']
2933,32985580,"Complete intraureteral stent placement relieves daytime urinary frequency compared with conventional placement in patients with an indwelling ureteral stent: post-hoc analysis of a randomized, controlled trial.","A previous randomized, controlled trial had demonstrated that complete intraureteral stent placement (CIU-SP) was superior to conventional stent placement (C-SP) in terms of improvement of stent-related urinary symptoms. However, it is unclear as to which subdomain symptom and cohort could benefit the most from CIU-SP compared to C-SP in urinary symptoms while considering the baseline urinary status. To determine this, a post-hoc analysis was performed using data from a previous study (CIU-SP group, n = 39; C-SP group, n = 41). We assessed the mean changes in the International Prostate Symptom Score (I-PSS) and the Overactive Bladder Symptom Score (OABSS) from baseline to day 14. Statistical comparison between the two groups was performed using analysis of covariance with adjustment of baseline urinary status as a covariate. Among 80 patients, the total I-PSS was significantly lower in the CIU-SP group than in the C-SP group in the cohort with mild urinary symptoms (P = 0.005), but not in those with moderate/severe symptoms (P = 0.521). The CIU-SP group showed significantly improved I-PSS and OABSS daytime frequencies, with the highest t statistic (2.47 and 2.10, respectively) among subdomains of both symptom scores compared with the C-SP group (both P < 0.001). In multivariate regression analysis, the stent placement method (CIU-SP vs. C-SP) was independently associated with the I-PSS daytime frequency on day 14 (P = 0.017). This study suggests that CIU-SP significantly improved stent-related daytime frequency compared with C-SP, and it may benefit especially those patients who have mild urinary symptoms before the placement of ureteral stents.",2020,"The CIU-SP group showed significantly improved I-PSS and OABSS daytime frequencies, with the highest t statistic (2.47 and 2.10, respectively) among subdomains of both symptom scores compared with the C-SP group (both P < 0.001).",['patients with an indwelling ureteral stent'],"['conventional placement', 'Complete intraureteral stent placement', 'conventional stent placement (C-SP', 'complete intraureteral stent placement (CIU-SP']","['total I-PSS', 'daytime urinary frequency', 'I-PSS and OABSS daytime frequencies', 'International Prostate Symptom Score (I-PSS) and the Overactive Bladder Symptom Score (OABSS', 'mild urinary symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}]","[{'cui': 'C1997470', 'cui_str': 'Total international prostate symptom score'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",80.0,0.0602491,"The CIU-SP group showed significantly improved I-PSS and OABSS daytime frequencies, with the highest t statistic (2.47 and 2.10, respectively) among subdomains of both symptom scores compared with the C-SP group (both P < 0.001).","[{'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan. yoshidtk@takii.kmu.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murota', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Taguchi', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}]",Scientific reports,['10.1038/s41598-020-72937-0']
2934,32985592,Inverted ILM-flap techniques variants for macular hole surgery: randomized clinical trial to compare retinal sensitivity and fixation stability.,"To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. Twenty-eight patients were randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. All patients underwent BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery. MH closed in all patients. BCVA rose from 20/100 (baseline) to 20/33 (1-month) in both groups, to 20/28 in CG versus 20/33 in FG (3-months) (p < 0.05). The central 4° RS rose from 11.5 and 12 dB to 19 and 19.5 dB (1-month) and to 22 and 20 dB (3-months), respectively, in CG and FG (p < 0.001). The central 10° RS rose from 11 and 15 dB to 22 and 20 dB (1-month) and to 23 and 20 dB (3-months), respectively, in CG and FG (p < 0.001). FS increased significantly more in CG. CG improved significantly more than FG in terms of BCVA, RS and FS. The average MH diameter was relatively small (397 µm); larger MHs may behave differently.Trial registration: Trial Registry: https://www.clinicaltrials.gov ; Identifier: NCT04135638. Registration date 22/10/2019.",2020,"BCVA rose from 20/100 (baseline) to 20/33 (1-month) in both groups, to 20/28 in CG versus 20/33 in FG (3-months) (p < 0.05).","['macular hole surgery', 'Twenty-eight patients']","['vitrectomy with either Cover or Fill ILM flap technique', 'ILM-flap techniques variants']","['average MH diameter', 'FS', 'closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS', 'BCVA', 'BCVA, RS and FS']","[{'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",28.0,0.0301762,"BCVA rose from 20/100 (baseline) to 20/33 (1-month) in both groups, to 20/28 in CG versus 20/33 in FG (3-months) (p < 0.05).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cacciamani', 'Affiliation': 'IRCCS - Fondazione Bietti, Via Livenza, 3, 00198, Rome, Italy. andrea_cacciamani@hotmail.com.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Gelso', 'Affiliation': 'Villa Dei Fiori, Acerra, Naples, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Scarinci', 'Affiliation': 'IRCCS - Fondazione Bietti, Via Livenza, 3, 00198, Rome, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ripandelli', 'Affiliation': 'IRCCS - Fondazione Bietti, Via Livenza, 3, 00198, Rome, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Medicine and Health Sciences ""Vincenzo Tiberio"", University of Molise, Campobasso, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Rossi', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}]",Scientific reports,['10.1038/s41598-020-72774-1']
2935,32998158,Diagnosing fraudulent baseline data in clinical trials.,"The first table in many articles reporting results of a randomized clinical trial compares baseline factors across arms. Results that appear inconsistent with chance trigger suspicion, and in one case, accusation and confirmation of data falsification. We confirm theoretically results of simulation analyses showing that inconsistency with chance is extremely difficult to prove in the absence of any information about correlations between baseline covariates. We offer a reasonable diagnostic to trigger further investigation.",2020,We confirm theoretically results of simulation analyses showing that inconsistency with chance is extremely difficult to prove in the absence of any information about correlations between baseline covariates.,[],[],[],[],[],[],,0.0761836,We confirm theoretically results of simulation analyses showing that inconsistency with chance is extremely difficult to prove in the absence of any information about correlations between baseline covariates.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Proschan', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Philadelphia, PA, United States of America.'}]",PloS one,['10.1371/journal.pone.0239121']
2936,32998206,The Effects of Long-Term Magnesium Creatine Chelate Supplementation on Repeated Sprint Ability (RAST) in Elite Soccer Players.,"AIM


The aim of the study was to evaluate the effects of 16 weeks of a low dose of magnesium creatine chelate supplementation on repeated sprint ability test (RAST) results in elite soccer players.
MATERIALS


Twenty well-trained soccer players participated in the study. The players were divided randomly into two groups: the supplemented group (SG = 10) and placebo group (PG = 10). Out of the 20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment. The SG ingested a single dose of 5500 mg of magnesium creatine chelate (MgCr-C), in 4 capsules per day, which was 0.07 g/kg/d. The PG received an identical 4 capsules containing corn starch. Before and after the study, the RAST was performed. In the RAST, total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP) were measured. Additionally, before and after the test, lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 -  (mmol/L) were evaluated. Also, in serum at rest, creatinine (mg/dL) concentration was measured.
RESULTS


After the study, significantly better results in TT, AP and MP were observed in the SG. No significant changes in the RAST results were observed in the PG. After the study, significant changes in the first 35 m sprint, as well as the sixth 35 m sprint results were registered in the SG, while insignificant changes occurred in the PG. A significantly higher creatinine concentration was observed. Also, a higher post-RAST concentration of LA, HCO 3 -  and lower values of pH were observed in April, May and June compared with baseline values.
CONCLUSIONS


The long timeframe, i.e., 16 weeks, of the low dose of magnesium creatine chelate supplementation improved the RAST results in the SG. Despite the long period of MgCr-C supplementation, in the end of the study, the creatinine level in the SG reached higher but still reference values.",2020,"After the study, significantly better results in TT, AP and MP were observed in the SG.","['elite soccer players', 'Twenty well-trained soccer players participated in the study', 'Elite Soccer Players', '20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment']","['identical 4 capsules containing corn starch', 'placebo', 'magnesium creatine chelate supplementation', 'magnesium creatine chelate (MgCr-C', 'Long-Term Magnesium Creatine Chelate Supplementation']","['Repeated Sprint Ability (RAST', 'higher post-RAST concentration of LA, HCO 3 -  and lower values of pH', 'serum at rest, creatinine (mg/dL) concentration', 'RAST results', 'repeated sprint ability test (RAST', 'lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 -  (mmol/L', 'TT, AP and MP', 'creatinine concentration', 'total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",20.0,0.0681599,"After the study, significantly better results in TT, AP and MP were observed in the SG.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Chycki', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Halz', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12102961']
2937,32998220,Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial.,"Epistaxis is a common debilitating manifestation in hereditary hemorrhagic telangiectasia (HHT), due to mucocutaneous telangiectases. The epistaxis can be difficult to control despite available treatments. Dysregulated angiogenesis has been shown to be associated with telangiectases formation. Topical propranolol has demonstrated antiangiogenic properties. We performed a two-phase study, i.e., a double-blind placebo-controlled phase, followed by an open-label phase. The aim of the study was assessment of safety and efficacy of nasal propranolol gel in HHT-related epistaxis. Twenty participants with moderate-severe HHT-related epistaxis were randomized to eight weeks of propranolol gel 1.5%, or placebo 0.5 cc, applied to each nostril twice daily; and continued propranolol for eight weeks in an open-label study. For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group,  p  = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL,  p  = 0.009); and intravenous iron and blood transfusion requirement decreased. The change in nasal endoscopy findings was not significant. During the open-label period, the ESS score improved significantly in the former placebo group (-1.99 ± 1.41,  p  = 0.005). The most common adverse event was nasal mucosa burning sensation. No cardiovascular events were reported. Our results suggest that topical propranolol gel is safe and effective in HHT-related epistaxis.",2020,"For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group,  p  = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL,  p  = 0.009); and intravenous iron and blood transfusion requirement decreased.","['Twenty participants with moderate-severe HHT-related epistaxis', 'HHT-related epistaxis', 'Hereditary Hemorrhagic Telangiectasia (HHT']","['Topical propranolol', 'propranolol', 'Topical Propranolol', 'placebo', 'topical propranolol gel', 'nasal propranolol gel', 'Placebo', 'propranolol gel 1.5%, or placebo 0.5 cc, applied to each nostril twice daily; and continued propranolol']","['epistaxis severity score (ESS', 'hemoglobin levels', 'intravenous iron and blood transfusion requirement', 'safety and efficacy', 'nasal endoscopy findings', 'ESS score', 'cardiovascular events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0039445', 'cui_str': 'Osler hemorrhagic telangiectasia syndrome'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",20.0,0.216774,"For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group,  p  = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL,  p  = 0.009); and intravenous iron and blood transfusion requirement decreased.","[{'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Mei-Zahav', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Gendler', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Elchanan', 'Initials': 'E', 'LastName': 'Bruckheimer', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prais', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Einat', 'Initials': 'E', 'LastName': 'Birk', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Muhamad', 'Initials': 'M', 'LastName': 'Watad', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Hematology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, Israel.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Soudry', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}]",Journal of clinical medicine,['10.3390/jcm9103130']
2938,32998912,Does an emergency access button increase the patients' satisfaction and feeling of safety with the out-of-hours health services? A randomised controlled trial in Denmark.,"OBJECTIVE


To investigate if the option to bypass the telephone queue can increase satisfaction and feeling of safety in callers.
DESIGN


Randomised controlled parallel superiority trial. Data from questionnaire survey.
SETTING


Two out-of-hours (OOH) services in Denmark.
PARTICIPANTS


217 510 citizens who called the OOH services between 4 September 2017 and 30 November 2017.
RANDOMISATION


Two-faze study period: First half with randomisation of participants based on their date of birth; even date randomised to intervention, uneven date randomised to control group. Second half with all participants included in intervention group.
INTERVENTION


Providing randomised callers (intervention group n=146 355) with the option to bypass the telephone waiting line through an emergency access button (EAB), while the rest got the normal service (control group n=71 155). All EAB users were invited to a questionnaire survey as well as random participants who did not use the EAB (of whom approximately 50% did not have the EAB option).
MAIN OUTCOME MEASURES


Satisfaction and feeling of safety in callers.
RESULTS


2208 of 6704 (32.9%) invited callers answered the questionnaire (intervention group n=1415 (users n=621, non-users n=794); control group n=793). The OR for answering in the two categories with highest satisfaction when provided with the EAB option was 1.34 (95% CI 1.07 to 1.68) for satisfaction with the waiting time, 1.21 (95% CI 0.91 to 1.60) for overall satisfaction and 1.46 (95% CI 1.12 to 1.89) for feeling of safety. Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
CONCLUSIONS


The EAB can provide fast access to OOH telephone advice in case of severe illness. It favours citizens perceived in most need of urgent healthcare and significantly increases both feeling of safety and patient satisfaction.
TRIAL REGISTRATION DETAILS


NCT02572115 (5 October 2015).",2020,"Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
","['Two out-of-hours (OOH) services in Denmark', '217\u2009510 citizens who called the OOH services between 4 September 2017 and 30 November 2017', 'All EAB users were invited to a questionnaire survey as well as random participants who did not use the EAB (of whom approximately 50% did not have the EAB option', '2208 of 6704 (32.9%) invited callers answered the questionnaire (intervention group n=1415 (users n=621, non-users n=794); control group n=793', 'callers']","['option to bypass the telephone waiting line through an emergency access button (EAB), while the rest got the normal service (control group n=71\u2009155', 'EAB']","['Satisfaction and feeling of safety in callers', 'feeling of safety and patient satisfaction', 'overall satisfaction', 'feeling of safety', 'satisfaction and feeling of safety']","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",217510.0,0.146243,"Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
","[{'ForeName': 'Jonas Fynboe', 'Initials': 'JF', 'LastName': 'Ebert', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet Health, Aarhus, Denmark jonasebert@ph.au.dk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Huibers', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet, Aarhus, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Public Health, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Collatz Christensen', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}, {'ForeName': 'Morten Bondo', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-030267']
2939,32998920,"Protocol of DEXPED trial: efficacy of intravenous dexamethasone, administered at the time of analgesic blocking of the lower limb, on postoperative pain in children: a randomised, placebo-controlled, double-blind trial.","INTRODUCTION


Dexamethasone is a drug used to prolong the postoperative analgesia in children after peripheral nerve blockade, although the dose usually used (0.2 mg/kg) has not been studied yet. This study is a monocentric, prospective, randomised, placebo-controlled, double-blinded study in a university hospital in France. The primary objective of the study is to evaluate the efficacy of 0.2 mg/kg intravenous dexamethasone on early postoperative pain in children aged 6-15 years, who require a lower limb peripheral nerve block following general anaesthesia.
METHODS AND ANALYSIS


Eighty children, aged 6-15 years, undergoing surgery for which peripheral nerve lower limb blockade with ropivacaine following general anaesthesia are included. The inclusion criteria are: children aged 6-15 years, with American Society of Anaesthesiologists physical status I or II and scheduled for surgery requiring a peripheral block of the lower limb for analgesic purposes, with a preoperative anaesthetic evaluation between 90 and 2 days before the surgery, with informed consent from legal representatives. General anaesthesia is performed. The patient receives, according to his group, either 0.2 mg/kg of dexamethasone intravenously at the start of anaesthetic induction or the same volume of placebo. Then, the peripheral block of the lower limb is performed with ropivacaine. The primary outcome is the total doses of opioid administered (in mg/kg of morphine equivalent) within 24 hours postoperatively. The secondary objectives are the evaluation of the effect of a single-dose intravenous dexamethasone at the time of anaesthetic induction, on the following parameters: onset of postoperative pain, duration of motor block, postoperative nausea and vomiting within 24 hours.
ETHICS AND DISSEMINATION


This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency. Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications.
TRIAL REGISTRATION NUMBER


NCT03618173.",2020,This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency.,"['university hospital in France', 'Eighty children, aged 6-15 years, undergoing surgery for which peripheral nerve lower limb blockade with ropivacaine following general anaesthesia are included', 'children aged 6-15 years, who require a lower limb peripheral nerve block following general anaesthesia', 'children aged 6-15 years, with American Society of Anaesthesiologists physical status I or II and scheduled for surgery requiring a peripheral block of the lower limb for analgesic purposes, with a preoperative anaesthetic evaluation between 90 and 2 days before the surgery, with informed consent from legal representatives', 'children']","['dexamethasone', 'Dexamethasone', 'placebo', 'ropivacaine']","['total doses of opioid', 'early postoperative pain', 'postoperative pain, duration of motor block, postoperative nausea and vomiting']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301860', 'cui_str': 'Legal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",80.0,0.487174,This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency.,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vautrin', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France nicolas_vautrin@hotmail.fr.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Thilly', 'Affiliation': ""Plateforme d'Aide à la Recherche Clinique, Université de Lorraine, Nancy, Lorraine, France.""}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Bernard', 'Affiliation': 'Département Méthodologie Promotion Investigation, Université de Lorraine, Nancy, Lorraine, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Wurtz', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Meistelman', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France.""}]",BMJ open,['10.1136/bmjopen-2020-036863']
2940,32998921,"Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial.","INTRODUCTION


Dance is an intrinsically motivating activity that includes social interaction, stimulation through music, the pleasure of moving despite pathology-induced motor limitations, and it also has good perceived benefits among participants. Feeling pleasure while moving is essential to finding the motivation to engage in a rehabilitation programme. It is, therefore, urgent to provide persons in a poststroke situation with motivating physical activity opportunities. Very few studies have examined dance in a stroke context, while it is highly adapted and effective for other chronic conditions.Our primary objective is to assess the effects of dance programme on patients' balance control after stroke. Our secondary objective is to investigate the effects of dance on cognitive function, strength, coordination, functional status, balance confidence, quality of life, motivation and adherence. Our hypothesis is that dance increases balance and motor capacities, and improves poststroke quality of life, adherence and motivation.
METHODS AND ANALYSIS


Forty-eight subjects with stroke in subacute phase will be randomised into two groups: (1) intervention (dance and standard rehabilitation) and (2) control (standard rehabilitation). Before intervention, stroke severity, cognitive abilities and motor capacities will be assessed. Two baseline tests will be planned to evaluate the stability of individuals. Participants will attend a weekly 60-min dance class for 6 weeks. Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups. Participant satisfaction with regard to dance will be tested, as well as adherence and adverse effects.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Swiss Ethics Committee of the CER Vaud (2019-01467). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences.
TRIAL REGISTRATION NUMBER


NCT04120467.",2020,"Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups.","[""patients' balance control after stroke"", 'Forty-eight subjects with stroke in subacute phase']","['intervention (dance and standard rehabilitation) and (2) control (standard rehabilitation', 'dance programme']","['Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale', 'stroke severity, cognitive abilities and motor capacities', 'balance control, cognitive-motor functions and quality of life', 'poststroke quality of life, adherence and motivation', 'cognitive function, strength, coordination, functional status, balance confidence, quality of life, motivation and adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",48.0,0.0846768,"Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morice', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Moncharmont', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Clémentine', 'Initials': 'C', 'LastName': 'Jenny', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Anne-Violette', 'Initials': 'AV', 'LastName': 'Bruyneel', 'Affiliation': 'Physiotherapy Department, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland anne-violette.bruyneel@hesge.ch.'}]",BMJ open,['10.1136/bmjopen-2020-037039']
2941,32999058,Effects of home-based telerehabilitation in patients with stroke: A randomized controlled trial.,"OBJECTIVE


To determine the effects of a 12-week home-based motor training telerehabilitation program in patients with subcortical stroke by combining motor function assessments and multimodality MRI analysis methods.
METHODS


Fifty-two patients with stroke and hemiplegia were randomly assigned to either a home-based motor training telerehabilitation (TR) group or a conventional rehabilitation (CR) group for 12 weeks. The Fugl-Meyer assessment (FMA) for upper and lower extremities and the modified Barthel Index were used as primary outcomes. The secondary outcomes included resting-state functional connectivity (rsFC) between the bilateral M1 areas, gray matter volumes of the primary motor cortex (M1) areas, and white matter integrity of the corticospinal tract. Analysis of covariance was applied to examine the effects of the home-based motor training TR program on neural function recovery and brain plasticity.
RESULTS


Compared with the CR group, the TR group showed significant improvement in the FMA ( p  = 0.011) and significantly increased M1-M1 rsFC ( p =  0.031) at the end of the rehabilitation. The M1-M1 rsFC change was significantly positively correlated with the FMA change in the TR group ( p  = 0.018).
CONCLUSION


This study showed a beneficial effect of the home-based motor training telerehabilitation program on motor function in patients with stroke, which was accompanied by enhanced interhemispheric functional connectivity of the M1 areas. We inferred that it is feasible, safe, and efficacious for patients with stroke to receive professional rehabilitation training at home. The combined use of imaging biomarkers should be encouraged in motor training clinical studies in patients with stroke.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with stroke with hemiplegia, home-based telerehabilitation compared to conventional rehabilitation significantly improves some motor function tests.",2020,"Compared with the CR group, the TR group showed significant improvement in the FMA ( P  = 0.011) and significantly increased M1-M1 rsFC ( P =  0.031) at the end of the rehabilitation.","['Fifty-two stroke patients with hemiplegia', 'subcortical stroke patients', 'stroke patients', 'stroke patients with hemiplegia']","['home-based motor training telerehabilitation (TR) group or a conventional rehabilitation (CR', 'home-based telerehabilitation', 'home-based motor training telerehabilitation program', 'professional rehabilitation training', 'home-based motor training TR program']","['Fugl-Meyer assessment (FMA) for upper and lower extremities and the modified Barthel index (MBI', 'FMA', 'M1-M1 rsFC change', 'M1-M1 rsFC', 'FMA change', 'resting-state functional connectivity (rsFC) between the bilateral M1 areas, gray matter volumes of the primary motor cortex (M1) areas and white matter integrity of the corticospinal tract (CST']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}]",52.0,0.0185388,"Compared with the CR group, the TR group showed significant improvement in the FMA ( P  = 0.011) and significantly increased M1-M1 rsFC ( P =  0.031) at the end of the rehabilitation.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Shufan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Qiao', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China.""}, {'ForeName': 'Chuancheng', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""From the Departments of Neurology (J.C.) and Department of Gastroenterology and Hepatology (D.S.), Zhongshan Hospital, Fudan University, Shanghai; Department of Gastroenterology and Hepatology (D.S.), Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen; Departments of Neurology (J.C., S.Z., Y.S., C.R.), Rehabilitation (F.Q., Y.Z.), and Radiology (J.L.), Shanghai Fifth People's Hospital, Fudan University; and Department of Neurology (C.R.), Shanghai East Hospital, Tongji University, China. rccfns17@sina.com.""}]",Neurology,['10.1212/WNL.0000000000010821']
2942,33000517,Magnification loupes influence on neck and trunk flexion of dental hygienists while scaling-A pilot study.,"OBJECTIVE


Work-related musculoskeletal disorders (MSDs) are common in the dental hygiene profession. Awkward postures contribute to MSDs and magnification loupes have been suggested to reduce this risk factor and minimize MSDs.
METHODS


After IRB approval, 24 hygienists were enrolled in the study: twelve hygienists wearing loupes with a standard manufacturer determined declination angle (control) and 12 hygienists wearing loupes with a custom measured declination angle (experimental). To measure changes in neck and trunk flexion, accelerometers were placed on the occipital region of head, cervical vertebrae C5, and thoracic vertebrae T5 and baseline posture was recorded. Typodonts with artificial calculus simulated the oral environment. Participants were randomly assigned to wear their designated loupes during the first or second trial of the experiment and scaled in each quadrant (UR, LR, UL, LL) of the mouth for two minutes. Participants completed the scaling task twice: in the loupes and no loupes condition in a counterbalanced order. Three-way mixed design ANOVA was used to determine posture differences in neck and trunk posture.
RESULTS


Those wearing custom loupes (M = 16.52, SD = 6.40) had significantly less trunk flexion while scaling compared to hygienists wearing standard loupes (M = 22.27, SD = 6.40), F(1, 22) = 7.14, P = .01. Neck flexion was not significantly affected while scaling between loupes vs no loupes or loupes type condition, (P's > .05).
CONCLUSION


Posture was partially impacted by loupes type. Custom loupes resulted in less trunk flexion. Neck flexion was not affected by either loupes type.",2020,"Neck flexion was not significantly affected while scaling between loupes v. no loupes or loupes type condition, (p's >.05).
",['24 hygienists were enrolled in the study: twelve hygienists wearing loupes with a standard manufacturer determined declination angle (control) and 12 hygienists wearing loupes with a custom measured declination angle (experimental'],[],"['Neck flexion', 'trunk flexion']","[{'cui': 'C0011369', 'cui_str': 'Dental hygienist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549181', 'cui_str': 'Loupes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",[],"[{'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",24.0,0.066081,"Neck flexion was not significantly affected while scaling between loupes v. no loupes or loupes type condition, (p's >.05).
","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Ludwig', 'Affiliation': 'School of Dental Hygiene, Old Dominion University, Norfolk,, Virginia, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Tolle', 'Affiliation': 'School of Dental Hygiene, Old Dominion University, Norfolk,, Virginia, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jenkins', 'Affiliation': 'School of Rehabilitation Sciences, Old Dominion University, Norfolk, Virginia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'School of Rehabilitation Sciences, Old Dominion University, Norfolk, Virginia, USA.'}]",International journal of dental hygiene,['10.1111/idh.12470']
2943,32978424,Comparison of gut microbiota in exclusively breast-fed and formula-fed babies: a study of 91 term infants.,"To compare gut microbiota of healthy infants that were exclusively breast-fed or formula-fed, we recruited 91 infants, who were assigned into three different groups and fed by breast milk (30 babies), formula A (30 babies) or formula B (31 babies) exclusively for more than 4 months after birth. Faecal bacterial composition was tested. Among different groups, α diversity was lower in breast-fed group than formula-fed groups in 40 days of age, but increased significantly in 6 months of age. The Bifidobacterium represented the most predominant genus and Enterobacteriaceae the second in all groups. In 40 days of age, Bifidobacterium and Bacteroides were significantly higher, while Streptococcus and Enterococcus were significantly lower in breast-fed group than they were in formula A-fed group. Lachnospiraceae was lower in breast-fed than formula B-fed group. Veillonella and Clostridioides were lower in breast-fed than formula-fed groups. In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups. There were also significant differences of microbiota between formula A-fed and formula B-fed groups. Those differences may have impacts on their long-term health.",2020,In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups.,"['91 term infants', 'gut microbiota in exclusively breast-fed and formula-fed babies', 'healthy infants that were exclusively breast-fed or formula-fed, we recruited 91 infants']",[],"['α diversity', 'Faecal bacterial composition', 'Lachnospiraceae', 'Veillonella and Clostridioides', 'Bifidobacterium and Bacteroides', 'Lachnospiraceae and Clostridioides']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0042446', 'cui_str': 'Veillonella'}, {'cui': 'C4406271', 'cui_str': 'Genus Clostridioides'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",91.0,0.0273905,In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups.,"[{'ForeName': 'Jingran', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. worldlizhengh@outlook.com.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}, {'ForeName': 'Yuheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Department of Neonatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhuo', 'Affiliation': 'Department of Neonatology, Inner Mongolia Maternal and Child Health Hospital, Hohhot, 010020, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatology, Inner Mongolia Maternal and Child Health Hospital, Hohhot, 010020, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}]",Scientific reports,['10.1038/s41598-020-72635-x']
2944,32978449,Heterogeneous ozone effects on the DNA methylome of bronchial cells observed in a crossover study.,"We used a randomized crossover experiment to estimate the effects of ozone (vs. clean air) exposure on genome-wide DNA methylation of target bronchial epithelial cells, using 17 volunteers, each randomly exposed on two separated occasions to clean air or 0.3-ppm ozone for two hours. Twenty-four hours after exposure, participants underwent bronchoscopy to collect epithelial cells whose DNA methylation was measured using the Illumina 450 K platform. We performed global and regional tests examining the ozone versus clean air effect on the DNA methylome and calculated Fisher-exact p-values for a series of univariate tests. We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air. We observed some participant-to-participant heterogeneity in ozone responses.",2020,"We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air.",['17 volunteers'],['ozone (vs. clean air) exposure'],['DNA methylome of bronchial cells'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4727083', 'cui_str': 'Methylome'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0178241,"We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air.","[{'ForeName': 'M-A C', 'Initials': 'MC', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA, USA. ma.bind@mail.harvard.edu.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rubin', 'Affiliation': 'Yau Center for Mathematical Sciences, Tsinghua University, Beijing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Department of Environmental Health Sciences, UC Berkeley School of Public Health, Berkeley, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Department of Environmental Sciences and Engineering, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ward-Caviness', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Statistics and Actuarial Sciences, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mirowsky', 'Affiliation': 'Department of Chemistry, SUNY College of Environmental Science and Forestry, Syracuse, NY, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwartz', 'Affiliation': 'Department of Environmental Health, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Diaz-Sanchez', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}]",Scientific reports,['10.1038/s41598-020-72068-6']
2945,32982335,No Evidence for Ceftobiprole-Induced Immune Hemolytic Anemia in Three Phase 3 Clinical Trials.,"Purpose


Drug-induced immune hemolytic anemia (DIIHA) is a rare but serious adverse event associated with a number of drugs, including second- and third-generation cephalosporins. A positive direct antiglobulin test (DAT) is a reliable finding in DIIHA, but positive results without evidence of hemolysis can occur, particularly in hospitalized patients. There have been no reports of hemolytic anemia in four previous Phase 3 trials or from post-marketing surveillance of the advanced-generation, broad-spectrum cephalosporin, ceftobiprole. The aim of this analysis was to review the incidence of positive DAT results and any evidence of hemolytic anemia from three recent Phase 3 trials of ceftobiprole.
Patients and Methods


Patients were enrolled in three Phase 3 randomized controlled trials: 94 pediatric patients with pneumonia received ceftobiprole in the BPR-PIP-002 trial; 335 adults with acute bacterial skin and skin structure infections received ceftobiprole in the TARGET trial; and 201 adults with  Staphylococcus aureus  bacteremia have been randomized 1:1 to ceftobiprole or daptomycin ± aztreonam in the ongoing ERADICATE trial. In all three trials, DAT results were obtained at baseline, and follow-up tests were performed either at the test of cure (TOC) visit (BPR-PIP-002), end-of-treatment (EOT) visit (TARGET), or both EOT and post-treatment Day 70 visits (ERADICATE).
Results


In the BPR-PIP-002 trial, five patients (all ceftobiprole treated) had a documented negative DAT result at baseline followed by a positive result at the TOC visit. One patient in the ongoing, blinded ERADICATE trial had a positive DAT result at both baseline and EOT. Results from other laboratory investigations showed no evidence of hemolytic anemia in these patients. No positive DAT results were reported in the TARGET trial.
Conclusion


No evidence of hemolytic anemia associated with ceftobiprole was observed in either adults or children across several indications in this analysis of three large Phase 3 trials.",2020,No evidence of hemolytic anemia associated with ceftobiprole was observed in either adults or children across several indications in this analysis of three large Phase 3 trials.,"['Patients and Methods\n\n\nPatients were enrolled in three Phase 3 randomized controlled trials: 94 pediatric patients with pneumonia received ceftobiprole in the BPR-PIP-002 trial; 335 adults with acute bacterial skin and skin structure infections received ceftobiprole in the TARGET trial; and 201 adults with  Staphylococcus aureus  bacteremia', 'hospitalized patients']","['ceftobiprole or daptomycin ± aztreonam', 'positive direct antiglobulin test (DAT']","['cure (TOC) visit (BPR-PIP-002), end-of-treatment (EOT) visit (TARGET), or both EOT', 'hemolytic anemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1100584', 'cui_str': 'Ceftobiprole'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia due to Staphylococcus aureus'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C1100584', 'cui_str': 'Ceftobiprole'}, {'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0200555', 'cui_str': 'Direct Coombs test'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002878', 'cui_str': 'Hemolytic anemia'}]",335.0,0.494729,No evidence of hemolytic anemia associated with ceftobiprole was observed in either adults or children across several indications in this analysis of three large Phase 3 trials.,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Hamed', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Wiktorowicz', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Assadi Gehr', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}]",Infection and drug resistance,['10.2147/IDR.S268269']
2946,32985362,Young Children Do Not Label Facial Expressions Spontaneously: A Brief Investigation of the Label Superiority Effect.,"A label superiority effect refers to the tendency of young children to categorize facial expressions based on emotion labels (e.g., ""happy"") more accurately than those based on photographs of facial expressions (e.g., ""smile""). However, it is unclear whether this effect stems from inaccuracies in children's spontaneous labeling of facial expressions or their tendency not to label facial expressions spontaneously. To further explore the label superiority effect, Japanese children aged 3-5 years ( N  = 48) were assigned to one of three conditions: label cue, photo cue, and compelled to label, and asked to categorize facial expressions by emotion by placing cards in a box. The children correctly put more facial expressions in the box for label cues than photo cues, but the compelled to label group performed as well as the label cues group. These results suggest that the label superiority effect occurs because children do not label facial expressions spontaneously, and this tendency may explain their difficulty in understanding facial expressions.",2020,"The children correctly put more facial expressions in the box for label cues than photo cues, but the compelled to label group performed as well as the label cues group.","['Young Children Do Not Label Facial Expressions Spontaneously', 'Japanese children aged 3-5\u2009years ( N \u2009=\u200948']","['label cue, photo cue, and compelled to label, and asked to categorize facial expressions by emotion by placing cards in a box']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]",[],48.0,0.0263315,"The children correctly put more facial expressions in the box for label cues than photo cues, but the compelled to label group performed as well as the label cues group.","[{'ForeName': 'Shinnosuke', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Faculty of Humanities, Kyoto University of Advanced Science, Kyoto, Japan.'}]",The Journal of genetic psychology,['10.1080/00221325.2020.1825923']
2947,32985372,Inducing positive involuntary mental imagery in everyday life: an experimental investigation.,"Positive involuntary mental imagery occurs frequently in daily life but evidence as to its functions and importance is largely indirect. The current study investigated a method to induce positive involuntary imagery in daily life, which would allow direct testing of its impact. An unselected student sample ( N  = 80) completed a single session of a positive imagery cognitive bias modification (CBM) paradigm, which involved listening to and imagining brief positive imagery scripts. Participants then recorded any involuntary memories of the imagined training scenarios in a three-day diary before returning to the lab for a follow-up assessment. Participants were randomised to imagine the scenarios in either an emotionally involved or emotionally detached manner, providing a test of the role of emotion in the subsequent experience of involuntary memories. Participants reported experiencing involuntary memories of the training scenarios in their daily life, but the number recorded did not differ between the experimental conditions. Exploratory analyses suggested that more vivid imagery and recall testing were associated with a greater number of involuntary memories. The study highlights the potential of the imagery CBM paradigm to further our understanding of the functions and potential importance of positive involuntary mental imagery in daily life.",2020,"Participants reported experiencing involuntary memories of the training scenarios in their daily life, but the number recorded did not differ between the experimental conditions.",[],"['single session of a positive imagery cognitive bias modification (CBM) paradigm, which involved listening to and imagining brief positive imagery scripts']","['experiencing involuntary memories', 'vivid imagery and recall testing', 'number of involuntary memories']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1268943', 'cui_str': 'Vivid color saturation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0606,"Participants reported experiencing involuntary memories of the training scenarios in their daily life, but the number recorded did not differ between the experimental conditions.","[{'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Blackwell', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Dooley', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Würtz', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Marcella L', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Margraf', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}]","Memory (Hove, England)",['10.1080/09658211.2020.1822413']
2948,32986176,Rationale and design of a randomized clinical trial to compare two antithrombotic strategies after left atrial appendage occlusion: double antiplatelet therapy vs. apixaban (ADALA study).,"BACKGROUND


Data on antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy. Up to date, different antithrombotic regimens with variable durations are currently used. In fact, the use of oral anticoagulation (OAC) or dual antiplatelet therapy (DAPT) with aspirin and clopidogrel during the initial phase (∓ 3 months post-LAAO) has been proposed as valid strategies. However, antiplatelet and OAC therapies have never been compared in a randomized study after left atrial appendage closure (LAAC). The purpose of the present study is to ascertain an optimal antithrombotic strategy after LAAC in terms of safety and efficacy. The study will compare a novel OAC (NOAC) with a highly safety profile like apixaban 5 mg/12 h or 2.5 mg/12 h (after dose adjustment or in high-risk patients) with standard antiplatelet therapy with DAPT. The aim of the study was to compare a strategy of anticoagulation with apixaban 5 mg/2.5 mg bid to the current standard of care (DAPT with aspirin and clopidogrel) after LAAO in patients with non-valvular atrial fibrillation (AF).
METHODS


This is a phase IV multicenter randomized, open-label, controlled trial comparing the efficacy and safety of apixaban vs. DAPT after LAAO, both for 3 months. The primary endpoint is a combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3 months of follow-up. Approximately 160 subjects will be enrolled and followed 12 months from randomization.
CONCLUSIONS


Considering the high risk of both thromboembolic and hemorrhagic events of patients undergoing LAAO, establishment of an appropriate antithrombotic therapy in terms of efficacy and safety after LAAO is of vital importance.
TRIAL REGISTRATION


EudraCT number: 2018-001013-32.",2020,"The primary endpoint is a combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3 months of follow-up.","['patients with non-valvular atrial fibrillation (AF', 'Approximately 160 subjects will be enrolled and followed 12\xa0months from randomization']","['apixaban 5\xa0mg/2.5', 'apixaban vs. DAPT', 'oral anticoagulation (OAC) or dual antiplatelet therapy (DAPT) with aspirin and clopidogrel', 'standard antiplatelet therapy with DAPT', 'novel OAC (NOAC', 'apixaban 5\xa0mg/12\xa0h or 2.5\xa0mg/12', 'current standard of care (DAPT with aspirin and clopidogrel']","['safety and efficacy', 'combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3\xa0months of follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.103733,"The primary endpoint is a combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3 months of follow-up.","[{'ForeName': 'Eduardo Josué', 'Initials': 'EJ', 'LastName': 'Flores-Umanzor', 'Affiliation': 'Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Cepas-Guillen', 'Affiliation': 'Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Dabit', 'Initials': 'D', 'LastName': 'Arzamendi', 'Affiliation': 'Cardiology Department, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': 'University Hospital of Salamanca, Institute of Biomedical Research in Salamanca (IBSAL), Faculty of Medicine, University of Salamanca, CIBERCV, Salamanca, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': 'Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Freixa', 'Affiliation': 'Cardiology Department, Cardiovascular Institute, Hospital Clinic, University of Barcelona, C/Villarroel, 170, 08036, Barcelona, Spain. freixa@clinic.cat.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00884-x']
2949,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE


Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI).
METHODS


In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion.
RESULTS


Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively.
CONCLUSIONS


The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287']
2950,32989866,Pilot study on the influence of cold atmospheric plasma on bacterial contamination and healing tendency of chronic wounds.,"BACKGROUND


Cold atmospheric plasma (CAP) has been used successfully for wound treatment, with thrice weekly treatment intervals. In this study, we wished to investigate whether comparably beneficial results can be achieved even with once weekly CAP treatment.
PATIENTS AND METHODS


In this randomized clinical pilot study (RCT) patients with therapy-refractory chronic wounds were examined over a maximum of twelve weeks. Groups 1 and 2 were treated with CAP once and twice a week, respectively. Patients in Group 3 received placebo therapy once a week.
RESULTS


Wound area decreased significantly by 63.0 % in Group 1 (n = 14, P = 0.005) and by 46.8 % in Group 2 (n = 13, P = 0.007). In Group 3 (n = 10) the wounds grew on average 17.5 % larger. A significant reduction in pain was measured in both CAP-treated groups (Group 1: P = 0.042; Group 2: P = 0.027). Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005). After the 12-week CAP treatment, the reduction in bacterial load compared to the day of study inclusion averaged 50.4 % for Group 1 and 35.0 % for Group 2.
CONCLUSIONS


Our RCT shows that treatment with CAP improves various aspects of wound healing in patients with therapy-refractory chronic wounds. The results obtained for once weekly treatment with CAP were not inferior to those obtained when CAP treatment was three times a week. Treatment once a week is also easier and more economical to implement in clinical routine.",2020,Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005).,"['chronic wounds', 'RCT) patients with therapy-refractory chronic wounds', 'patients with therapy-refractory chronic wounds']","['placebo therapy', 'CAP', 'Cold atmospheric plasma (CAP', 'cold atmospheric plasma']","['wound-specific quality of life', 'reduction in bacterial load', 'wound healing', 'Wound area', 'pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0231065,Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005).,"[{'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Moelleken', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Jockenhöfer', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Wiegand', 'Affiliation': 'Department of Dermatology, Jena University Medical Center.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Buer', 'Affiliation': 'Department of Medical Microbiology, Essen University Medical Center.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Department of Medical Psychology and Behavioral Immunobiology, Essen University Medical Center.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dissemond', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}]",Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG,['10.1111/ddg.14294']
2951,32990249,Evaluation of the Effectiveness of a Novel Brain-Computer Interface Neuromodulative Intervention to Relieve Neuropathic Pain Following Spinal Cord Injury: Protocol for a Single-Case Experimental Design With Multiple Baselines.,"BACKGROUND


Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention.
OBJECTIVE


The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury.
METHODS


We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration.
RESULTS


This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021.
CONCLUSIONS


This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/20979.",2020,A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback.,"['individuals with neuropathic pain following spinal cord injury', 'Following Spinal Cord Injury', 'Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020', 'spinal cord injury neuropathic pain', 'participants with spinal cord injury neuropathic pain', 'people with neuropathic pain after spinal cord injury', 'individuals with spinal cord injury']","['novel brain-computer interface neuromodulative treatment', 'novel brain-computer interface-based neuromodulative intervention', 'self-developed brain-computer interface neuromodulative intervention', 'Novel Brain-Computer Interface Neuromodulative Intervention', 'brain-computer interface neuromodulative intervention', 'ANZCTR']","['Neuropathic Pain', 'pain interference', 'quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",3.0,0.19551,A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback.,"[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Hesam-Shariati', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Newton-John', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Avinash K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'School of Computer Science, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Tirado Cortes', 'Affiliation': 'School of Computer Science, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Tien-Thong Nguyen', 'Initials': 'TN', 'LastName': 'Do', 'Affiliation': 'School of Computer Science, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Craig', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute, Sydney, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Middleton', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Northern Clinical School, University of Sydney, Kolling Institute, Sydney, Australia.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Trost', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Chin-Teng', 'Initials': 'CT', 'LastName': 'Lin', 'Affiliation': 'School of Computer Science, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'Gustin', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.'}]",JMIR research protocols,['10.2196/20979']
2952,32990250,Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation Treatment: Protocol for a Hybrid Type I Randomized Controlled Trial.,"BACKGROUND


Modifiable risk factors such as tobacco use, physical inactivity, and poor diet account for a significant proportion of the preventable deaths in Canada. These factors are also known to cluster together, thereby compounding the risks of morbidity and mortality. Given this association, smoking cessation programs appear to be well-suited for integration of health promotion activities for other modifiable risk factors. The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system. However, there is no available clinical decision support system for physical inactivity and poor diet, which are among the leading modifiable risk factors for chronic diseases.
OBJECTIVE


The aim of this study is to assess whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcomes.
METHODS


This study is designed as a hybrid type 1 effectiveness/implementation randomized controlled trial to evaluate a web-enabled clinical decision support system for supporting practitioners in addressing patients' physical activity and diet as part of smoking cessation treatment in a primary care setting. This design was chosen as it allows for simultaneous testing of the intervention, its delivery in target settings, and the potential for implementation in real-world situations. Intervention effectiveness will be measured using a two-arm randomized controlled trial. Health care practitioners will be unblinded to their patients' treatment allocation; however, patients will be blinded to whether their practitioner receives the clinical decision support system for physical activity and/or fruit/vegetable consumption. The evaluation of implementation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
RESULTS


Recruitment for the primary outcome of this study is ongoing and will be completed in November 2020. Results will be reported in March 2021.
CONCLUSIONS


The findings of the study will provide much needed insight into whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcome. Furthermore, the implementation evaluation would provide insight into the feasibility of online-based interventions for physical activity and diet in a smoking cessation program. Addressing these risk factors simultaneously could have significant positive effects on chronic disease and cancer prevention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04223336; https://clinicaltrials.gov/ct2/show/NCT04223336.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19157.",2020,"The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system.","['Health care practitioners', 'patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system']",['Web-Based Clinical Decision Support System'],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]",[],,0.0552539,"The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system.","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Minian', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Mathangee', 'Initials': 'M', 'LastName': 'Lingam', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Veldhuizen', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Dragonetti', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zawertailo', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Valerie H', 'Initials': 'VH', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Schizophrenia Division, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Wayne K', 'Initials': 'WK', 'LastName': 'deRuiter', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Melamed', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Selby', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}]",JMIR research protocols,['10.2196/19157']
2953,32986563,Correction: Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/14200.].,2020,[This corrects the article DOI: 10.2196/14200.].,['People Living With HIV (the Ziphamandla Study'],['Correction: Nurse-Delivered Cognitive Behavioral Therapy'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0634602,[This corrects the article DOI: 10.2196/14200.].,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lena S', 'Initials': 'LS', 'LastName': 'Andersen', 'Affiliation': 'HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Smith-Alvarez', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Magidson', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Jasper S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}]",JMIR research protocols,['10.2196/24074']
2954,32987492,Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks.,"BACKGROUND


Regional nerve blocks are an integral part of multimodal analgesia and should be chosen based on their efficacy, convenience, and minimal side effects. Here, we compare the use of pectoral (PEC II) and serratus-intercostal fascial plane (SIFP) blocks in breast carcinoma cases undergoing modified radical mastectomy (MRM) in terms of the postoperative analgesic efficacy and shoulder mobility.
METHODS


The primary outcome of this prospective controlled study was to compare the postoperative static and dynamic pain scores, and the secondary outcome was to assess the shoulder pain, range of shoulder joint motion, and hemodynamic parameters. Sixty patients were randomly allocated to three groups and given general anesthesia. All patients received paracetamol, diclofenac, and rescue doses of tramadol based on the Institute's Acute Pain Service (APS) policy. No block was performed in group C (control), whereas groups P and S received PEC II and SIFP blocks, respectively, before surgical incision.
RESULTS


The groups were comparable in terms of age, weight, height, and body mass index distribution (P > 0.05). Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.",2020,"Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.","['patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks', 'patients receiving SIFP', 'Sixty patients', 'breast carcinoma cases undergoing']","['tramadol', 'modified radical mastectomy (MRM', 'pectoral (PEC II) and serratus-intercostal fascial plane (SIFP) blocks', 'general anesthesia', 'paracetamol, diclofenac']","['shoulder pain, range of shoulder joint motion, and hemodynamic parameters', 'dynamic and static pain relief with better shoulder pain scores', 'Shoulder pain relief and shoulder mobility', 'Dynamic pain relief', 'postoperative static and dynamic pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0575978,"Dynamic pain relief was significantly better 12 and 24 h postoperatively in groups P (P = 0.034 and P = 0.04, respectively) and S (P = 0.01 and P = 0.02, respectively) compared to group C. Shoulder pain relief and shoulder mobility were better in group S, while the hemodynamic parameters were more stable in group P.
CONCLUSIONS


Both SIFP and PEC blocks have comparable dynamic and static pain relief with better shoulder pain scores in patients receiving SIFP.","[{'ForeName': 'Ushkiran', 'Initials': 'U', 'LastName': 'Kaur', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Shamshery', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Prakash', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ramya Chakrapani', 'Initials': 'RC', 'LastName': 'Valiveru', 'Affiliation': 'Department of Endocrine Surgery, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Prabhaker', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Biostatistics and Health Informatics, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Korean journal of anesthesiology,['10.4097/kja.20159']
2955,32987642,"Effects of a Low-Fat Vegan Diet on Gut Microbiota in Overweight Individuals and Relationships with Body Weight, Body Composition, and Insulin Sensitivity. A Randomized Clinical Trial.","Diet modulates gut microbiota and plays an important role in human health. The aim of this study was to test the effect of a low-fat vegan diet on gut microbiota and its association with weight, body composition, and insulin resistance in overweight men and women. We enrolled 168 participants and randomly assigned them to a vegan ( n  = 84) or a control group ( n  = 84) for 16 weeks. Of these, 115 returned all gut microbiome samples. Gut microbiota composition was assessed using uBiome Explorer™ kits. Body composition was measured using dual energy X-ray absorptiometry. Insulin sensitivity was quantified with the predicted clamp-derived insulin sensitivity index from a standard meal test. Repeated measure ANOVA was used for statistical analysis. Body weight decreased in the vegan group (treatment effect -5.9 kg [95% CI, -7.0 to -4.9 kg];  p  < 0.001), mainly due to a reduction in fat mass (-3.9 kg [95% CI, -4.6 to -3.1 kg];  p  < 0.001) and in visceral fat (-240 cm 3  [95% CI, -345 to -135 kg];  p  < 0.001). PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83 [95% CI, +0.48 to +1.2];  p  < 0.001). The relative abundance of Faecalibacterium prausnitzii increased in the vegan group (+5.1% [95% CI, +2.4 to +7.9%];  p  < 0.001) and correlated negatively with changes in weight (r = -0.24;  p  = 0.01), fat mass (r = -0.22;  p  = 0.02), and visceral fat (r = -0.20;  p  = 0.03). The relative abundance of Bacteroides fragilis decreased in both groups, but less in the vegan group, making the treatment effect positive (+18.9% [95% CI, +14.2 to +23.7%];  p  < 0.001), which correlated negatively with changes in weight (r = -0.44;  p  < 0.001), fat mass (r = -0.43;  p  < 0.001), and visceral fat (r = -0.28;  p  = 0.003) and positively with PREDIM (r = 0.36;  p  < 0.001), so a smaller reduction in Bacteroides fragilis was associated with a greater loss of body weight, fat mass, visceral fat, and a greater increase in insulin sensitivity. A low-fat vegan diet induced significant changes in gut microbiota, which were related to changes in weight, body composition, and insulin sensitivity in overweight adults, suggesting a potential use in clinical practice.",2020,"PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83","['overweight men and women', '168 participants and randomly assigned them to a vegan ( n  = 84) or a', 'human health']","['low-fat vegan diet', 'Low-Fat Vegan Diet', 'control group']","['weight, body composition, and insulin sensitivity', 'gut microbiota', 'gut microbiota and its association with weight, body composition, and insulin resistance', 'fat mass', 'Gut microbiota composition', 'relative abundance of Faecalibacterium prausnitzii', 'relative abundance of Bacteroides fragilis', 'Body composition', 'Gut Microbiota in Overweight Individuals and Relationships with Body Weight, Body Composition, and Insulin Sensitivity', 'Insulin sensitivity', 'changes in weight', 'body weight, fat mass, visceral fat', 'visceral fat', 'Body weight', 'insulin sensitivity', 'M, insulin sensitivity index (PREDIM']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",168.0,0.123136,"PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rembert', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Alwarith', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Willy N', 'Initials': 'WN', 'LastName': 'Yonas', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, 35127 Padua, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Agnello', 'Affiliation': 'uBiome Inc., San Francisco, CA 94103, USA.'}, {'ForeName': 'Robynne', 'Initials': 'R', 'LastName': 'Chutkan', 'Affiliation': 'Department of Gastroenterology, Georgetown MedStar Hospital, Washington, DC 20007, USA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Barnard', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}]",Nutrients,['10.3390/nu12102917']
2956,32988670,"Contrast-Enhanced Ultrasound Guided Transoral Core Needle Biopsy: A Novel, Safe and Well-Tolerated Procedure for Obtaining High-Quality Tissue in Patients with Oral Cancer.","The aim of the prospective study described here was to compare the tolerability, safety and diagnostic value of contrast-enhanced ultrasound-guided transoral core needle biopsy (CEUS-CNB) with that of conventional US-guided transoral CNB (US-CNB) and standard incisional biopsy in patients with oral masses. Between June 2017 and November 2019, consecutive patients with oral masses referred for biopsy were randomly assigned to undergo incisional biopsy, US-CNB or CEUS-CNB. Procedure time, intra‑operative blood loss volume, diagnostic performance and pain level before and after the procedure assessed by visual analogue score (VAS) were recorded and compared among the three procedures. Finally, 238 patients with pathology confirmation were analyzed: 80 patients underwent incisional biopsy, 78 patients US-CNB and 80 patients CEUS-CNB. In this study, no significant difference was found in biopsy time between CEUS-CNB, US-CNB and incisional biopsy (75 ± 11 s vs. 73.6 ± 12 s vs. 77 ± 13 s, p = 0.24). CEUS-CNB achieved the highest sensitivity (CEUS-CNB: 100%, US-CNB: 88.5%, incisional biopsy: 84.3%), negative predictive value (CEUS-CNB: 100%, US-CNB: 81.3%, incisional biopsy: 78.4%) and accuracy (CEUS-CNB: 100%, US-CNB: 92.3%, incisional biopsy: 90%). The VAS score for incision biopsy was higher (p = 0.01) and the amount of bleeding was larger (p < 0.001), yet there was no significant difference between CEUS-CNB and US-CNB. Our results indicate CEUS-guided transoral CNB is an efficient, safe and well-tolerated procedure, with biopsy time comparable to and diagnostic performance better than those of conventional US-guided transoral CNB and incisional biopsy.",2020,"The VAS score for incision biopsy was higher (p = 0.01) and the amount of bleeding was larger (p < 0.001), yet there was no significant difference between CEUS-CNB and US-CNB.","['Patients with Oral Cancer', '238 patients with pathology confirmation were analyzed: 80 patients underwent', 'patients with oral masses', 'Between June 2017 and November 2019, consecutive patients with oral masses referred for biopsy']","['incisional biopsy', 'contrast-enhanced ultrasound-guided transoral core needle biopsy (CEUS-CNB', 'standard incisional biopsy', 'incisional biopsy, US-CNB or CEUS-CNB', 'CEUS-guided transoral CNB', 'Contrast-Enhanced Ultrasound Guided Transoral Core Needle Biopsy', 'conventional US-guided transoral CNB (US-CNB']","['negative predictive value', 'biopsy time between CEUS-CNB, US-CNB and incisional biopsy', 'Procedure time, intra‑operative blood loss volume, diagnostic performance and pain level', 'VAS score for incision biopsy', 'amount of bleeding', 'visual analogue score (VAS', 'tolerability, safety and diagnostic value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0577565', 'cui_str': 'Mass of oral cavity'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0184922', 'cui_str': 'Incisional biopsy - action'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184922', 'cui_str': 'Incisional biopsy - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",238.0,0.0140257,"The VAS score for incision biopsy was higher (p = 0.01) and the amount of bleeding was larger (p < 0.001), yet there was no significant difference between CEUS-CNB and US-CNB.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: graceof@163.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Electrical and Computer Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Minggang', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Ziyue', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Jifen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Ultrasound Medical Center, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China; North Sichuan Medical College, Nanchong, China.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.09.001']
2957,32986891,"Baclofen destabilises breathing during sleep in healthy humans: A randomised, controlled, double-blind crossover trial.","AIMS


Periodic breathing is frequent in patients with severe heart failure. Apart from being an indicator of severity, periodic breathing has its own deleterious consequences (sleep-related oxygen desaturations, sleep fragmentation), which justifies attempts to correct it irrespective of the underlying disease. Animal models and human data suggest that baclofen can reconfigure respiratory central pattern generators. We hypothesised that baclofen, a GABA B  agonist, may thus be able to correct periodic breathing in humans.
METHODS


Healthy volunteers were exposed to hypoxia during sleep. Participants who developed periodic breathing (n = 14 [53 screened]) were randomly assigned to double-blind oral baclofen (progressively increased to 60 mg/d) or placebo. The primary outcome was the coefficient of variation (CoVar) of respiratory cycle total time considered as an indicator of breathing irregularity. Secondary outcomes included the CoVar of tidal volume, apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity (noise limit).
RESULTS


The analysis was conducted in 9 subjects after exclusion of incomplete datasets. CoVar of respiratory cycle total time significantly increased with baclofen during non-rapid eye movement sleep (median with placebo 56.00% [37.63-78.95]; baclofen 85.42% [68.37-86.40], P = .020; significant difference during the N1-N2 phases of sleep but not during the N3 phase). CoVar of tidal volume significantly increased during N1-N2 sleep. The apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity were not significantly different between placebo and baclofen.
CONCLUSION


Baclofen did not stabilise breathing in our model. On the contrary, it increased respiratory variability. Baclofen should probably not be used in patients with or at risk of periodic breathing.",2020,"The apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity were not significantly different between placebo and baclofen.
","['healthy humans', 'Participants who developed periodic breathing (n=14 - 53 screened', 'patients with or at risk of periodic breathing', '9 subjects after exclusion of incomplete datasets', 'patients with severe heart failure', 'Healthy volunteers']","['Periodic breathing', 'placebo', 'double-blind oral baclofen', 'Baclofen destabilises breathing']","['coefficient of variation of tidal volume (CoVarVT), apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity (noise limit', 'apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity', 'CoVarVT significantly increased during N1-N2 sleep', 'coefficient of variation of respiratory cycle total time (CoVarTT) considered as an indicator of breathing irregularity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1313952', 'cui_str': 'Respiration intermittent'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1313952', 'cui_str': 'Respiration intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4704917', 'cui_str': 'NREM Stage 2'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.204813,"The apnoea-hypopnoea index, sleep fragmentation index and ventilatory complexity were not significantly different between placebo and baclofen.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Straus', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Teulier', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Morel', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Wattiez', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': ""Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP. Sorbonne Université, Hôpital Pitié Salpêtrière, Département de Santé Publique, Unité de Recherche Clinique Salpêtrière-Charles Foix, Centre de Pharmacoépidémiologie (Cephepi), Sorbonne Université, Paris, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giboin', 'Affiliation': 'AP-HP, Groupe Hospitalier APHP-Sorbonne Université, Hôpital Pitié-Salpêtrière, Unité de Recherche Clinique Salpêtrière-Charles Foix, Paris, France.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Charbit', 'Affiliation': 'INSERM and AP-HP, CIC-1901 module Paris-Est, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dasque', 'Affiliation': 'INSERM and AP-HP, CIC-1901 module Paris-Est, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bodineau', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Chenuel', 'Affiliation': 'CHRU de Nancy, Service des Explorations Fonctionnelles Respiratoires et Centre Universitaire de Médecine du Sport et Activité Physique Adaptée, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Straus', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Attali', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14569']
2958,32986904,Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study.,"New rehabilitation programs based on action observation therapy (AOT) are effective in improving motor function in children with congenital hemiplegia. In this pilot study we tested the potential effects of AOT on the reorganization of the motor system by functional magnetic resonance imaging (fMRI). As part of a randomized trial, eight subjects (age range: 6.2-14.5 years) with congenital hemiplegia were randomly assigned to an experimental (EG) or control (CG) group. All children underwent a clinical and neurophysiological assessment with Assisting Hand Assessment (AHA), MRI, and fMRI at baseline (T0), 1(T1), and 8(T2) weeks after the end of 3-week treatment. For the EG, AOT consisted in the observation of uni/bimanual goal-directed actions followed by their execution. CG watched same-duration computer games and then performed the same actions in the same order used in the EG. fMRI study was carried out using two different paradigms, for exploring sensory-motor network (SMN) localization and action observation network (AON). The pattern of brain activation was generally similar between T0 and T1 for both groups, while it was more widespread at T2, compared to T0 and T1, in the EG. This enlargement was coupled with functional improvement at AHA. Single-subject analysis shows a reduction of lateralization indexes both for the AON and the SMN. This pilot study, despite the small sample, showed the fMRI feasibility for providing relevant biomarkers of brain plasticity for monitoring the AOT response in children with congenital hemiplegia. The study was registered at http://www.clinicaltrials.gov (identifier NCT01016496).",2020,New rehabilitation programs based on action observation therapy (AOT) are effective in improving motor function in children with congenital hemiplegia.,"['children with congenital hemiplegia', '8 subjects (age range: 6.2-14.5 years) with congenital hemiplegia']","['New rehabilitation programs based on action observation therapy (AOT', 'Reorganization of action observation and sensory-motor networks after action observation therapy', 'experimental (EG) or control (CG', 'functional magnetic resonance imaging (fMRI', 'AOT']","['clinical and neurophysiological assessment with Assisting Hand Assessment (AHA), MRI and fMRI at baseline (T0), 1(T1) and 8(T2', 'sensory-motor network (SMN) localization and action observation network (AON', 'pattern of brain activation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",8.0,0.0246247,New rehabilitation programs based on action observation therapy (AOT) are effective in improving motor function in children with congenital hemiplegia.,"[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Sgandurra', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biagi', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Fogassi', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sicola', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Tosetti', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cioni', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}]",Developmental neurobiology,['10.1002/dneu.22783']
2959,33002731,Gamma-transcranial alternating current stimulation and theta-burst stimulation: inter-subject variability and the role of BDNF.,"OBJECTIVE


The main limitation of neuromodulation techniques is inter-subject variability. Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS) allows to shape cortical plasticity. However, it is unknown whether γ-tACS modifies TBS-induced response variability. In this study, we measured the inter-subject variability of TBS-γ tACS and controlled the effect of the Brain-Derived Neurotrophic Factor (BDNF) Val66Met polymorphism.
METHODS


Intermittent TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS were applied in randomised sessions. Inter-subject variability was measured using grand average and clustering methods. TBS-γ tACS effects on motor evoked potentials (MEP) were compared between Val/Val and Met carriers.
RESULTS


We found that γ-tACS boosted iTBS-induced MEP facilitation and cancelled cTBS-induced MEP depression. Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders. The clustering method demonstrated that TBS-γ tACS response varied between subjects, a phenomenon unrelated to the BDNF genotype.
CONCLUSIONS


Enhancing γ oscillations through tACS boosts iTBS-induced LTP-like plasticity and suppresses cTBS-induced LTD-like plasticity of the primary motor cortex in a reliable manner. The BDNF Val66Met polymorphism does not influence these effects.
SIGNIFICANCE


Since γ-tACS significantly increases the number of iTBS responders, it may be used in clinical settings.",2020,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,[],"['Gamma-transcranial alternating current stimulation and theta-burst stimulation', 'γ-tACS', 'TBS-γ tACS', 'Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS', 'TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS']","['motor evoked potentials (MEP', 'TBS-γ tACS response', 'percentage of iTBS responders']",[],"[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]",,0.0513527,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guerra', 'Affiliation': 'IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asci', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zampogna', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': ""D'Onofrio"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Petrucci', 'Affiliation': ""Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ginevrino', 'Affiliation': 'Istituto di Medicina Genomica, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy; Laboratory of Medical Genetics, Bambino Gesù Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berardelli', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy. Electronic address: alfredo.berardelli@uniroma1.it.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Suppa', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.08.017']
2960,33002752,A comparison of ultrasound-guided rotator interval and posterior glenohumeral injection techniques for MR shoulder arthrography.,"PURPOSE


The aim of this prospective, randomized study was to compare the performance of a rotator interval approach with the posterior glenohumeral approach for ultrasound-guided contrast injection prior to MR shoulder arthrography.
METHOD


This study was approved by the institutional review board. One hundred and twenty consecutive patients referred for MR shoulder arthrography were randomized into four groups: rotator interval approach in-plane (n = 30); rotator interval approach out-of-plane (n = 30); posterior approach in-plane (n = 30); and posterior approach out-of plane (n = 30). Outcome measures included procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10). MR arthrograms were assessed for adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage.
RESULTS


All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography. In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance. The posterior glenohumeral approach was less technically demanding though had a higher frequency of contrast leakage and caused more patient discomfort than the rotator interval approach.
CONCLUSION


For ultrasound-guided shoulder joint injection, an in-plane approach is preferable. The posterior glenohumeral approach is less technically demanding though causes more patients discomfort than the rotator interval approach possibly due to the longer needle path.",2020,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","['One hundred and twenty consecutive patients referred for MR shoulder arthrography', 'MR shoulder arthrography', 'All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography']","['posterior glenohumeral approach for ultrasound-guided contrast injection', 'ultrasound-guided rotator interval and posterior glenohumeral injection techniques', 'rotator interval approach in-plane (n\xa0=\xa030); rotator interval approach out-of-plane (n\xa0=\xa030); posterior approach in-plane (n\xa0=\xa030); and posterior approach out-of plane']","['procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10', 'patient discomfort', 'adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0203224', 'cui_str': 'Arthrography of shoulder'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282419', 'cui_str': 'Technical Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",120.0,0.0381212,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","[{'ForeName': 'Carita', 'Initials': 'C', 'LastName': 'Tsoi', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chris S C', 'Initials': 'CSC', 'LastName': 'Tsai', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Eric K C', 'Initials': 'EKC', 'LastName': 'Law', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ryan K L', 'Initials': 'RKL', 'LastName': 'Lee', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alex W H', 'Initials': 'AWH', 'LastName': 'Ng', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Griffith', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. Electronic address: griffith@cuhk.edu.hk.'}]",Clinical imaging,['10.1016/j.clinimag.2020.08.031']
2961,33002791,Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.,"OBJECTIVES


Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population.
MATERIALS AND METHODS


One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence.
RESULTS


There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants.
CONCLUSIONS


The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted.
TRIAL REGISTRATION


NCT01550822.",2020,There were no significant changes in primary or secondary outcomes at 6 months.,"['One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack', 'Stroke Survivors', 'Healthy Eating and Lifestyle after Stroke']","['HEALS intervention', 'occupational therapist-led group lifestyle intervention vs. usual care', 'intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives', 'didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity', 'occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS', 'Lifestyle Intervention']","['change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care', 'change in body mass index, fruit/vegetable intake, and physical activity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.121269,There were no significant changes in primary or secondary outcomes at 6 months.,"[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States; Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; Los Angeles County Department of Health Services, Los Angeles, CA, United States. Electronic address: towfighi@usc.edu.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; University of Cincinnati, Cincinnati, OH, United States.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, CA, United States. Electronic address: Natalie.valle@stjoe.org.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente, Los Angeles, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Annaliese', 'Initials': 'A', 'LastName': 'Espinosa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Dombish', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States. Electronic address: chu381@usc.edu.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Atkins', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105323']
2962,33003548,The Effects of a 12-Month Weight Loss Intervention on Cognitive Outcomes in Adults with Overweight and Obesity.,"Obesity is associated with poorer executive functioning and reward sensitivity. Yet, we know very little about whether weight loss through diet and/or increased exercise engagement improves cognitive function. This study evaluated whether weight loss following a dietary and exercise intervention was associated with improved cognitive performance. We enrolled 125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention. Participants were assigned to one of three groups: energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week. All participants completed tests measuring executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT). Following the intervention, weight significantly decreased in all groups. A MANCOVA controlling for age, sex and race revealed a significant multivariate effect of group on cognitive changes. Post-hoc ANCOVAs revealed a Group x Time interaction only on IGT reward sensitivity, such that the high exercise group improved their performance relative to the other two intervention groups. Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score. Changes in weight were not associated with other changes in cognitive performance. Engaging in a high amount of exercise improved reward sensitivity above and beyond weight loss alone. This suggests that there is additional benefit to adding exercise into behavioral weight loss regimens on executive functioning, even without additional benefit to weight loss.",2020,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","['125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention', 'Adults with Overweight and Obesity']","['energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week', 'dietary and exercise intervention', 'Weight Loss Intervention']","['cognitive performance', 'weight loss', 'weight', 'executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT', 'IGT net payoff score', 'Cognitive Outcomes', 'reward sensitivity above and beyond weight loss alone']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",125.0,0.0173392,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","[{'ForeName': 'Jamie C', 'Initials': 'JC', 'LastName': 'Peven', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Lesnovskaya', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Porter', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Donofry', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Watt', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Stillman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}]",Nutrients,['10.3390/nu12102988']
2963,33003575,Effects of Elastic Band Exercise on Functional Fitness and Blood Pressure Response in the Healthy Elderly.,"Purpose : This study investigated the effects of 12 weeks of moderate intensity elastic band exercise (EBE) on functional fitness and blood pressure parameters in the elderly.  Methods : 27 healthy older adults were randomly assigned to an exercise group ( n  = 15, age: 75.1 ± 1.4 years) and a control group ( n  = 12, age: 72.3 ± 1.4 years). Participants performed EBE for 60 min, three times a week, over the course of three months. The EBE consisted of incremental resistance and aerobic exercises designed to improve whole body fitness. Functional fitness and resting cardiovascular parameters were assessed before and after the exercise training program.  Results : Grip strength, sit and reach, and one-leg stance improved significantly in the exercise group, while no significant improvements were found in chair stand and timed up and go ( p  < 0.05). Cardiovascular parameters including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pulse pressure significantly decreased in the exercise group relative to the control group ( p  < 0.05).  Conclusions : Findings of the present study suggest that safe, inexpensive, and easily accessible EBE program with circuit training components play a significant role in improving upper and lower body fitness, as well as cardiovascular fitness, in the elderly.",2020,"Grip strength, sit and reach, and one-leg stance improved significantly in the exercise group, while no significant improvements were found in chair stand and timed up and go ( p  < 0.05).","['Healthy Elderly', 'elderly', 'group ( n  = 15, age: 75.1 ± 1.4 years) and a control group ( n  = 12, age: 72.3 ± 1.4 years', '27 healthy older adults']","['exercise', 'moderate intensity elastic band exercise (EBE', 'Elastic Band Exercise']","['Grip strength, sit and reach, and one-leg stance', 'functional fitness and blood pressure parameters', 'systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pulse pressure', 'Functional Fitness and Blood Pressure Response', 'Functional fitness and resting cardiovascular parameters', 'chair stand and timed up and go', 'improving upper and lower body fitness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}]",27.0,0.010174,"Grip strength, sit and reach, and one-leg stance improved significantly in the exercise group, while no significant improvements were found in chair stand and timed up and go ( p  < 0.05).","[{'ForeName': 'Hyun-Min', 'Initials': 'HM', 'LastName': 'Choi', 'Affiliation': 'Department of Sports Science, Gwangju University, 277, Gwangju-si 61743, Korea.'}, {'ForeName': 'Chansol', 'Initials': 'C', 'LastName': 'Hurr', 'Affiliation': 'Department of Physical Education, Jeonbuk National University, 567, Jeonju-si, Jeollabuk-do 54896, Korea.'}, {'ForeName': 'Sukwon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Jeonbuk National University, 567, Jeonju-si, Jeollabuk-do 54896, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197144']
2964,33003591,"Optimal Time of Thermotherapy for Reducing Pain, Anxiety, and Side Effects in Arteriovenous Fistula Puncture Patients: A Randomized Controlled Trial.","Chronic renal failure patients undergoing hemodialysis complain of moderate pain from repeated punctures of the arteriovenous fistula. This study examined the optimal application time of thermotherapy for reducing pain, anxiety, and side effects during arteriovenous fistula puncture. This study was conducted as a single-blinded randomized controlled trial. The participants were arteriovenous fistula puncture patients with chronic renal failure who were divided into two thermotherapy groups and one control group. This study was approved by the institutional review board and registered with the Clinical Research Information Service (KCT0003768). Differences between groups regarding pain, anxiety, and side effects were analyzed using one-way ANOVA, the χ 2  test, and the Scheffé test. A significant difference was observed between the 10-min and 20-min thermotherapy groups and the control group in terms of the pain they experienced. Additionally, more side effects were encountered in the 20-min thermotherapy group than in the 10-min group. The 10-min application of thermotherapy for an arteriovenous fistula puncture showed the same pain-reducing effect as the conventional 20-min application. The study confirmed a 10-min application of thermotherapy to be an effective nursing intervention for pain relief without side effects.",2020,The study confirmed a 10-min application of thermotherapy to be an effective nursing intervention for pain relief without side effects.,"['arteriovenous fistula puncture', 'Arteriovenous Fistula Puncture Patients', 'Chronic renal failure patients undergoing hemodialysis complain of moderate pain from repeated punctures of the arteriovenous fistula', 'participants were arteriovenous fistula puncture patients with chronic renal failure']","['Thermotherapy', 'thermotherapy']","['pain, anxiety, and side effects', 'side effects', 'Pain, Anxiety, and Side Effects']","[{'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0020548', 'cui_str': 'Thermotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0519157,The study confirmed a 10-min application of thermotherapy to be an effective nursing intervention for pain relief without side effects.,"[{'ForeName': 'Yangok', 'Initials': 'Y', 'LastName': 'Back', 'Affiliation': 'Department of Nursing, Yeosu Hankook Hospital, 10 Yeocheoncheyukgongwon-gil, Yeosu, Jeonnam 59684, Korea.'}, {'ForeName': 'Yoonyoung', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Sunchon National University, 255 Jungang-ro, Suncheon, Jeonnam 57922, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197147']
2965,32985088,Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials.,"AIMS


The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial. Here we describe the baseline characteristics of participants in GALACTIC-HF and how these compare with other contemporary trials.
METHODS AND RESULTS


Adults with established HFrEF, New York Heart Association (NYHA) functional class ≥II, ejection fraction ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non-white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N-terminal pro-B-type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC-HF randomized patients representative of recent heart failure registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m 2  (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594).
CONCLUSIONS


GALACTIC-HF enrolled a well-treated, high-risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation.",2020,"The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial.","['patients with heart failure with reduced ejection fraction (HFrEF', 'HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n\xa0=\xa01386), enrolled as inpatients (n\xa0=\xa02084), systolic blood pressure\u2009<\u2009100\u2009mmHg (n\xa0=\xa01127), estimated glomerular filtration rate\xa0<\u200930\u2009mL', 'Adults with established HFrEF, New York Heart Association functional class (NYHA)\u2009≥\u2009II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year', '8256 patients [male (79%), non-white (22%), mean age 65\u2009years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT-proBNP 1971\u2009pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials']","['placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing', 'sacubitril-valsartan']",['safety and efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030701', 'cui_str': 'Patient Representatives'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",8256.0,0.275864,"The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latino America (ECLA), Rosario, Argentina.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, ASST Spedali Civili; Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arias-Mendoza', 'Affiliation': 'Instituto Nacional de Cardiologìa, Mexico City, Mexico.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital & Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Saarland University, Universitätsklinikum des Saarlandes, Homburg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bonderman', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Corbalan', 'Affiliation': 'Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Crespo-Leiro', 'Affiliation': 'Complexo Hospitalario Universitario A Coruña (CHUAC). CIBERCV. INIBIC. Universidade da Coruña, A Coruña, Spain.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Dahlström', 'Affiliation': 'Department of Cardiology and Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Echeverria Correa', 'Affiliation': 'Fundacion Cardiovascular de Colombia, Floridablanca, Colombia.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'University of Athens, Athens, Greece.'}, {'ForeName': 'Cândida', 'Initials': 'C', 'LastName': 'Fonseca', 'Affiliation': 'Hospital S. Francisco Xavier, CHLO; NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goncalvesova', 'Affiliation': 'Commenius Universtity, Bratislava, Slovakia.'}, {'ForeName': 'Assen R', 'Initials': 'AR', 'LastName': 'Goudev', 'Affiliation': 'Department of Cardiology, Queen Giovanna University Hospital and Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute and Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Detroit, MI, USA.'}, {'ForeName': 'Mayanna', 'Initials': 'M', 'LastName': 'Lund', 'Affiliation': 'Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Macdonald', 'Affiliation': ""St. Vincent's Hospital Sydney, Darlinghurst, Australia.""}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Mareev', 'Affiliation': 'University Clinic of Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Momomura', 'Affiliation': 'Saitama Citizens Medical Center, Saitama, Japan.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Felix J A', 'Initials': 'FJA', 'LastName': 'Ramires', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pranas', 'Initials': 'P', 'LastName': 'Serpytis', 'Affiliation': 'Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'University of Cape Town, Johannesburg, South Africa.'}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Suter', 'Affiliation': 'Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Tomcsanyi', 'Affiliation': 'St. John of God Hospital, Budapest, Hungary.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Vandekerckhove', 'Affiliation': 'AZ Sint-Lucas, Ghent, Belgium.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mehmet B', 'Initials': 'MB', 'LastName': 'Yilmaz', 'Affiliation': 'Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm INI CRCT, CHRU Nancy, Nancy, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Sharpsten', 'Affiliation': 'Amgen, Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Legg', 'Affiliation': 'Amgen, Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Siddique A', 'Initials': 'SA', 'LastName': 'Abbasi', 'Affiliation': 'Amgen, Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Varin', 'Affiliation': 'Servier, Suresnes, France.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Inc., Thousand Oaks, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2015']
2966,32985991,Effectiveness of Human Versus Computer-Based Instructions for Exercise on Physical Activity-Related Health Competence in Patients with Hip Osteoarthritis: Randomized Noninferiority Crossover Trial.,"BACKGROUND


Hip and knee osteoarthritis is ranked as the 11th highest contributor to global disability. Exercise is a core treatment in osteoarthritis. The model for physical activity-related health competence describes possibilities to empower patients to perform physical exercises in the best possible health-promoting manner while taking into account their own physical condition. Face-to-face supervision is the gold standard for exercise guidance.
OBJECTIVE


The aim of this study was to evaluate whether instruction and guidance via a digital app is not inferior to supervision by a physiotherapist with regard to movement quality, control competence for physical training, and exercise-specific self-efficacy.
METHODS


Patients with clinically diagnosed hip osteoarthritis were recruited via print advertisements, emails and flyers. The intervention consisted of two identical training sessions with one exercise for mobility, two for strength, and one for balance. One session was guided by a physiotherapist and the other was guided by a fully automated tablet computer-based app. Both interventions took place at a university hospital. Outcomes were assessor-rated movement quality, and self-reported questionnaires on exercise-specific self-efficacy and control competence for physical training. Participants were randomly assigned to one of two treatment sequences. One sequence started with the app in the first session followed by the physiotherapist in the second session after a minimum washout phase of 27 days (AP group) and the other sequence occurred in the reverse order (PA group). Noninferiority was defined as a between-treatment effect (gIG)<0.2 in favor of the physiotherapist-guided training, including the upper confidence interval. Participants, assessors, and the statistician were neither blinded to the treatment nor to the treatment sequence.
RESULTS


A total of 54 participants started the first training session (32 women, 22 men; mean age 62.4, SD 8.2 years). The treatment sequence groups were similar in size (PA: n=26; AP: n=28). Seven subjects did not attend the second training session (PA: n=3; AP: n=4). The app was found to be inferior to the physiotherapist in all outcomes considered, except for movement quality of the mobility exercise (gIG -0.13, 95% CI -0.41-0.16). In contrast to the two strengthening exercises in different positions (supine gIG 0.76, 95% CI 0.39-1.13; table gIG 1.19, 95% CI 0.84-1.55), movement quality of the balance exercise was close to noninferiority (gIG 0.15, 95% CI -0.17-0.48). Exercise-specific self-efficacy showed a strong effect in favor of the physiotherapist (gIG 0.84, 95% CI 0.46-1.22). In terms of control competence for physical training, the app was only slightly inferior to the physiotherapist (gIG 0.18, 95% CI -0.14-0.50).
CONCLUSIONS


Despite its inferiority in almost all measures of interest, exercise-specific self-efficacy and control competence for physical training did improve in patients who used the digital app. Movement quality was acceptable for exercises that are easy to conduct and instruct. The digital app opens up possibilities as a supplementary tool to support patients in independent home training for less complex exercises; however, it cannot replace a physiotherapist.
TRIAL REGISTRATION


German Clinical Trial Register: DRKS00015759; http://www.drks.de/DRKS00015759.",2020,"The app was found to be inferior to the physiotherapist in all outcomes considered, except for movement quality of the mobility exercise (gIG -0.13, 95% CI -0.41-0.16).","['Patients with Hip Osteoarthritis', 'Patients with clinically diagnosed hip osteoarthritis were recruited via print advertisements, emails and flyers', 'osteoarthritis', '54 participants started the first training session (32 women, 22 men; mean age 62.4, SD 8.2 years', 'patients who used the digital app']",['Human Versus Computer-Based Instructions for Exercise'],"['movement quality of the balance exercise', 'assessor-rated movement quality, and self-reported questionnaires on exercise-specific self-efficacy and control competence for physical training', 'Physical Activity-Related Health Competence', 'movement quality of the mobility exercise', 'Exercise-specific self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",54.0,0.0291887,"The app was found to be inferior to the physiotherapist in all outcomes considered, except for movement quality of the mobility exercise (gIG -0.13, 95% CI -0.41-0.16).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Durst', 'Affiliation': 'Department of Sports Medicine, University Hospital, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Inka', 'Initials': 'I', 'LastName': 'Roesel', 'Affiliation': 'Department of Sports Medicine, University Hospital, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Gorden', 'Initials': 'G', 'LastName': 'Sudeck', 'Affiliation': 'Interfaculty Research Institute for Sports and Physical Activity, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sassenberg', 'Affiliation': 'Social Processes Lab, Leibniz-Institut für Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Krauss', 'Affiliation': 'Department of Sports Medicine, University Hospital, University of Tuebingen, Tuebingen, Germany.'}]",Journal of medical Internet research,['10.2196/18233']
2967,32985993,Lessons Learned From an Evaluation of Serious Gaming as an Alternative to Mannequin-Based Simulation Technology: Randomized Controlled Trial.,"BACKGROUND


The use of new technology like virtual reality, e-learning, and serious gaming can offer novel, more accessible options that have been demonstrated to improve learning outcomes.
OBJECTIVE


The aim of this study was to compare the educational effectiveness of serious game-based simulation training to traditional mannequin-based simulation training and to determine the perceptions of physicians and nurses. We used an obstetric use case, namely electronic fetal monitoring interpretation and decision making, for our assessment.
METHODS


This study utilized a mixed methods approach to evaluate the effectiveness of the new, serious game-based training method and assess participants' perceptions of the training. Participants were randomized to traditional simulation training in a center with mannequins or serious game training. They then participated in an obstetrical in-situ simulation scenario to assess their learning. Participants also completed a posttraining perceptions questionnaire.
RESULTS


The primary outcome measure for this study was the participants' performance in an in-situ mannequin-based simulation scenario, which occurred posttraining following a washout period. No significant statistical differences were detected between the mannequin-based and serious game-based groups in overall performance, although the study was not sufficiently powered to conclude noninferiority. The survey questions were tested for significant differences in participant perceptions of the educational method, but none were found. Qualitative participant feedback revealed important areas for improvement, with a focus on game realism.
CONCLUSIONS


The serious game training tool developed has potential utility in providing education to those without access to large simulation centers; however, further validation is needed to demonstrate if this tool is as effective as mannequin-based simulation.",2020,"No significant statistical differences were detected between the mannequin-based and serious game-based groups in overall performance, although the study was not sufficiently powered to conclude noninferiority.",[],"['traditional simulation training in a center with mannequins or serious game training', 'serious game-based simulation training to traditional mannequin-based simulation training']","[""participants' performance in an in-situ mannequin-based simulation scenario""]",[],"[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",,0.0666357,"No significant statistical differences were detected between the mannequin-based and serious game-based groups in overall performance, although the study was not sufficiently powered to conclude noninferiority.","[{'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Benda', 'Affiliation': 'National Center for Human Factors in Healthcare, MedStar Institute for Innovation, MedStar Health, Washington, DC, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Kellogg', 'Affiliation': 'Emergency Medicine, Georgetown University School of Medicine, Washington, DC, United States.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hoffman', 'Affiliation': 'National Center for Human Factors in Healthcare, MedStar Institute for Innovation, MedStar Health, Washington, DC, United States.'}, {'ForeName': 'Rollin J', 'Initials': 'RJ', 'LastName': 'Fairbanks', 'Affiliation': 'Emergency Medicine, Georgetown University School of Medicine, Washington, DC, United States.'}, {'ForeName': 'Tamika', 'Initials': 'T', 'LastName': 'Auguste', 'Affiliation': ""Women's and Infants' Services, MedStar Washington Hospital Center, Washington, DC, United States.""}]",JMIR serious games,['10.2196/21123']
2968,32980384,Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy in early breast cancer: A randomized clinical trial of KROG 15-03.,"PURPOSE


To investigate the safety and efficacy of intensity-modulated radiation therapy (IMRT) for early breast cancer compared with 3-dimensional conformal radiotherapy (3D-CRT) in a prospective and randomized trial.
METHODS AND MATERIALS


From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery were enrolled and randomly assigned into IMRT and 3D-CRT. The primary endpoint was 3-year locoregional recurrence-free survival (LRRFS). The secondary endpoints were recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory. The radiation dose for the 3D-CRT arm was 59.4 Gy in 33 fractions for 6.5 weeks. It was 57.4 Gy in 28 fractions with simultaneous integrated boost for 5.5 weeks for the IMRT arm.
RESULTS


Of 693 patients, 349 and 344 patients received 3D-CRT and IMRT, respectively. There was no significant difference in LRRFS between the two arms. Conformity index of planning target volume was significantly superior in the IMRT arm than the 3D-CRT arm (p < 0.001). The mean lung dose and V 5 -V 50  for the ipsilateral lung were significantly lower in the IMRT arm than the 3D-CRT arm (all p < 0.05). The incidence of grade 2 or higher dermatitis was significantly lower in the IMRT arm (p = 0.009).
CONCLUSION


Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage. When IMRT is used in breast cancer, the irradiation dose to an ipsilateral lung and skin toxicity can be reduced.",2020,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","['693 patients', '349 and 344 patients received', 'From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery', 'early breast cancer']","['3D-CRT and IMRT', 'IMRT', '3-dimensional conformal radiotherapy (3D-CRT', 'IMRT and 3D-CRT', 'Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy', 'intensity-modulated radiation therapy (IMRT']","['Conformity index of planning target volume', 'incidence of grade 2 or higher dermatitis', 'LRRFS', '3-year locoregional recurrence-free survival (LRRFS', 'mean lung dose and V 5 -V 50  for the ipsilateral lung', 'recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",693.0,0.0805317,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","[{'ForeName': 'Kyu Hye', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': ""Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Ja', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae Uk', 'Initials': 'JU', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Department of Radiation Oncology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Bae Kwon', 'Initials': 'BK', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Joo Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: koppul@catholic.ac.kr.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.043']
2969,32980586,Desire to drink as a function of laboratory-induced social stress among adolescents.,"BACKGROUND AND OBJECTIVES


Research consistently demonstrates a link between social anxiety and alcohol-related problems; however, the majority of work has been retrospective, and conducted with adults. Despite an extensive literature highlighting coping-related motives as an underlying mechanism, real-time work presents mixed findings, and no published research has examined an adolescent sample using experimental psychopathology techniques.
METHODS


The current study tested whether (1) history of social anxiety symptoms positively correlated with alcohol-related cognitions following laboratory-induced social stress, (2) state anxiety was positively correlated with alcohol-related cognitions, and (3) whether the nature of the stressor (performance versus rejection) impacted the strength of identified relations, in a sample of community-recruited adolescents reporting recent alcohol use. Participants (n = 114; M age  = 16.01; 64% girls) were randomly assigned to either a performance- or rejection-oriented task.
RESULTS


Findings indicated that history of social anxiety symptoms was positively correlated with state anxiety elicited by both tasks. Further, history of social anxiety symptoms was not related to change in desire to drink, but was positively related to the belief that alcohol 'would make me feel better.' State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks. Finally, the nature of the task did not moderate responding.
LIMITATIONS


Single site, community sampling confines interpretations, and the tasks did not fully perform as expected.
CONCLUSIONS


Further study is needed; however, the current findings support the contention that socially-oriented distress may be a developmentally-relevant, malleable target for prevention efforts aimed at problematic alcohol use among adolescents.",2020,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"['114; M age \xa0=\xa016.01; 64% girls', 'adolescents', 'Participants (n\xa0']",['performance- or rejection-oriented task'],"['history of social anxiety symptoms', 'State anxiety']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0194071,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: heidemarie.blumenthal@unt.edu.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: ReneeCloutier@my.unt.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: MeganDouglas@my.unt.edu.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Kearns', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: NathanKearns@my.unt.edu.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: CaitlynCarey@my.unt.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101617']
2970,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND


This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS


Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS


Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS


Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
2971,32980829,Comparative Evaluation of Chitosan Chlorhexidine Mouthwash in Plaque Control: A Preliminary Randomized Controlled Clinical Trial.,"AIMS


The purpose of the present study was to compare the effect of a new mouth wash formulation consisting of chlorhexidine and chitosan on dental plaque and its reduction to that of chlorhexidine or chitosan alone.
MATERIALS AND METHODS


This study was a single-blind randomized clinical trial with a parallel group design of 3 months duration. Patients (20-40 years) who fulfilled the inclusion and exclusion criteria were assigned equally to group 1: chlorhexidine (0.2%), group 2: chitosan (0.5%) or group 3: chlorhexidine - chitosan combination group. The clinical parameters were recorded at baseline, 6weeks and at 3months. All patients received thorough oral prophylaxis and were instructed to rinse with 10ml of mouthwash twice daily for 1 minute.
RESULTS


The combination of chitosan and chlorhexidine showed a statistically significant reduction (p less than0.05) in plaque indices from baseline at all time intervals when compared to that of chlorhexidine or chitosan alone.
CONCLUSIONS


Our study demonstrates that by unifying the properties of chitosan and chlorhexidine may result in a superior antiplaque effect than that of chlorhexidine alone.",2020,"The combination of chitosan and chlorhexidine showed a statistically significant reduction (p less than0.05) in plaque indices from baseline at all time intervals when compared to that of chlorhexidine or chitosan alone.
","['Plaque Control', 'Patients (20-40 years) who fulfilled the inclusion and exclusion criteria']","['Chitosan Chlorhexidine Mouthwash', 'chlorhexidine - chitosan combination group', 'chlorhexidine and chitosan', 'chlorhexidine or chitosan alone', 'chlorhexidine']",['plaque indices'],"[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",,0.0864947,"The combination of chitosan and chlorhexidine showed a statistically significant reduction (p less than0.05) in plaque indices from baseline at all time intervals when compared to that of chlorhexidine or chitosan alone.
","[{'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Vilasan', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Prabhuji Munivenkatappa Lakshmaiah', 'Initials': 'PML', 'LastName': 'Venkatesh', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Karthikeyan Bangalore', 'Initials': 'KB', 'LastName': 'Varadhan', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India. Email:drkarthikeyanbv@gmail.com.'}, {'ForeName': 'Joann Pauline', 'Initials': 'JP', 'LastName': 'George', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Dubey', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}]",Journal of the International Academy of Periodontology,[]
2972,32981123,The Effects of a Brief Motivational Intervention for Alcohol Use through Stages of Change among Nontreatment Seeking Injured Patients.,"BACKGROUND


Little is known about the mechanisms of change underlying brief interventions and the patient characteristics that may affect them. The present study tested whether the stages of change mediate the effects of a BMI with and without a telephone booster relative to brief advice (i.e., multiple mediation). Further, the present study tested whether the effects of the BMI conditions on the stages of change were contingent on patients' alcohol use severity (i.e., moderated mediation).
METHODS


The present study is a secondary analysis using data from injured adult patients at 3 trauma centers who were screened for inclusion in the study and randomly assigned to brief advice (n = 200), BMI (n = 203), or BMI with a telephone booster (n = 193) (Field et al., 2014). Participants completed a baseline assessment and 3-, 6-, and 12-month follow-up assessments that included self-report measures of the stages of change, alcohol use, and alcohol-related problems, as well as other variables of interest.
RESULTS


The results demonstrated significant and consistent mediation at p < 0.05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up. However, moderated mediation analyses suggested that the effects of the BMI conditions on the stages of change were not contingent on patients' alcohol use severity.
CONCLUSIONS


This study contributes to the understanding of stages of change as potential mechanisms of change in BMI. Directions for future research are discussed.",2020,"The results demonstrated significant and consistent mediation at p < .05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up.","['injured adult patients at three trauma centers who were screened for inclusion in the study and randomly assigned to brief advice (n = 200), BMI (n = 203), or', 'Non-Treatment Seeking Injured Patients']","['Brief Motivational Intervention', 'BMI with a telephone booster']",['alcohol problems'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]",,0.0195696,"The results demonstrated significant and consistent mediation at p < .05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up.","[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'From the, Department of Psychology, (CAF), Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, El Paso, Texas, USA.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Center on Alcohol, Substance use, And Addictions, (DKR), University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Yessenia', 'Initials': 'Y', 'LastName': 'Castro', 'Affiliation': 'Steve Hicks School of Social Work, (YC, KS), University of Texas at Austin, Texas, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Alonso Cabriales', 'Affiliation': 'Arts and Sciences Division, (JAC), University of New Mexico-Gallup, Gallup, New Mexico, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wagler', 'Affiliation': 'Department of Mathematical Science, (AW), University of Texas at El Paso El Paso, Texas, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'von Sternberg', 'Affiliation': 'Steve Hicks School of Social Work, (YC, KS), University of Texas at Austin, Texas, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14466']
2973,32989888,Rapid Administration of Methoxyflurane to Patients in the Emergency Department (RAMPED) Study: A Randomized Controlled Trial of Methoxyflurane Versus Standard Care.,"OBJECTIVE


The objective was to evaluate the effectiveness of methoxyflurane versus standard care for the initial management of severe pain among adult emergency department (ED) patients.
METHODS


This randomized parallel-group open-label phase IV trial of methoxyflurane was conducted in a tertiary hospital ED setting in Australia. Inclusion criteria required adult patients to have an initial pain score ≥ 8 on the 11-point Numerical Rating Scale (NRS). Patients were randomized 1:1 to receive either inhaled methoxyflurane (3 mL) or standard analgesic treatment at ED triage. The primary outcome was the proportion of patients achieving clinically substantial pain reduction, defined as a ≥50% drop in the pain score at 30 minutes. Secondary outcomes included the pain score at multiple time points (15, 30, 60, 90 minutes) and the difference in the proportion of patients achieving a >2-point reduction on the NRS.
RESULTS


There were 120 patients randomized and analyzed between September 4, 2019, and January 16, 2020. The primary outcome was achieved in six (10%) patients in the methoxyflurane arm and three (5%) in the standard care arm (p = 0.49). A higher proportion of patients in the methoxyflurane arm reported a >2-point drop on the NRS at all time points (17% vs. 5% at 15 minutes, 25% vs. 9% at 30 minutes, 30% vs. 10% at 60 minutes, and 33% vs. 13% at 90 minutes). Methoxyflurane use was also associated with lower median pain scores at all time points.
CONCLUSION


Initial management with inhaled methoxyflurane in the ED did not achieve the prespecified substantial reduction in pain, but was associated with clinically significant lower pain scores compared to standard therapy.",2020,"A higher proportion of patients in the methoxyflurane arm reported >2 point drop on the NRS at all time points (17% vs 5% at 15 minutes, 25% vs 9% at 30 minutes, 30% vs 10% at 60 minutes, and 33% versus 13% at 90 minutes).","['tertiary hospital ED setting in Australia', '120 patients randomised and analysed between 4 September 2019 and 16 January 2020', 'to Patients in the Emergency Department (RAMPED) Study', 'severe pain among adult emergency department (ED) patients']","['Methoxyflurane', 'methoxyflurane', 'inhaled methoxyflurane (3mls) or standard analgesic treatment at ED triage', 'inhaled methoxyflurane']","['NRS', 'pain score', 'median pain scores', 'proportion of patients achieving a >2 point reduction on the NRS', 'proportion of patients achieving clinically substantial pain reduction', 'initial pain score ≥8 on the 11-point Numerical Rating Scale (NRS', 'pain scores', 'pain score at multiple timepoints']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.125564,"A higher proportion of patients in the methoxyflurane arm reported >2 point drop on the NRS at all time points (17% vs 5% at 15 minutes, 25% vs 9% at 30 minutes, 30% vs 10% at 60 minutes, and 33% versus 13% at 90 minutes).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brichko', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Ravali', 'Initials': 'R', 'LastName': 'Gaddam', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Roman', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Luckhoff', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jennings', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash, Melbourne, Australia.'}, {'ForeName': 'De Villiers', 'Initials': 'V', 'LastName': 'Smit', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cameron', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Biswadev', 'Initials': 'B', 'LastName': 'Mitra', 'Affiliation': 'From, Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14144']
2974,32989941,Design of the Redefining Therapy in Early COPD Study.,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70. Recruitment began in July 2017 with the goal of enrolling 580 participants. The baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires. A follow-up phone call at 4 weeks assesses symptoms and safety. The second and final visit at week 12 includes spirometry before and after study drug (hourly over 3 hours) and follow-up symptom questionnaires. The primary endpoint is the proportion of individuals who experience a 4-unit improvement in St George's Respiratory Questionnaire (SGRQ) score at 12 weeks without treatment failure, defined as an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics. Key secondary endpoints include the proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI. Other secondary endpoints include area under the curve 0-3 hours for FEV 1  after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC (FEF 25-75 ) iso-volume FEF 25-75  and mean change in symptoms and rescue medication use based on daily diary. We anticipate results to be available in 2021. This paper describes the RETHINC study and explains the rationale behind it.",2020,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70.",['Recruitment began in July 2017 with the goal of enrolling 580 participants'],"['indacaterol/glycopyrrolate', 'placebo']","['COPD Assessment Test (CAT) score', 'efficacy and safety', 'area under the curve 0-3 hours for FEV 1  after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC', 'proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI', ""proportion of individuals who experience a 4-unit improvement in St George's Respiratory Questionnaire (SGRQ) score"", 'lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics', 'baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4517818', 'cui_str': '580'}]","[{'cui': 'C4058826', 'cui_str': 'glycopyrronium / indacaterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",580.0,0.221688,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70.","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Prescott', 'Initials': 'P', 'LastName': 'Woodruff', 'Affiliation': 'Division of Pulmonary and Critical Care, University of California, San Francisco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.4.2020.0157']
2975,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND


Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS


To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS


A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS


Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION


FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
2976,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND


Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE


This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS


Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS


Higher f 0  mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0  was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0  and avoidance reduction.
DISCUSSION


This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
2977,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
2978,32987894,Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis-A Randomized Controlled Trial.,"Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM;  n  = 47; 50.28 ± 11.90 years) or control ( n  = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference ( p  = 0.251). If patients attended more than 50% of the training sessions, a significant group effect ( p  = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary ( p  = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.",2020,"If patients attended more than 50% of the training sessions, a significant group effect ( p  = 0.034) was evident in favor of LSM.","['patients with ulcerative colitis', 'Patients with Ulcerative Colitis', 'Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL', 'Ninety-seven patients in clinical remission with impaired HrQoL']","['single workshop of intense training in naturopathic self-help strategies', 'comprehensive lifestyle-modification program', 'Comprehensive Lifestyle-Modification', '10 week comprehensive lifestyle-modification program (LSM']","['HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ', 'SF-36 mental component summary', 'HrQoL', 'HrQoL and decrease disease activity', 'IBDQ subscales; generic HrQoL; disease activity and microbiome', 'IBDQ sum score', 'Disease activity microbiome and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0684336', 'cui_str': 'Impairment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.139456,"If patients attended more than 50% of the training sessions, a significant group effect ( p  = 0.034) was evident in favor of LSM.","[{'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Germany, Chair for Integrative Medicine, University of Duisburg-Essen, Buger Straße 80, 96049 Bamberg, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Schöls', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Cinar', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Eilert', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kofink', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zempel', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Universitätsstraße 150, 44801 Bochum, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Lauche', 'Affiliation': 'National Centre for Naturopathic Medicine, Southern Cross University, Lismore, Lismore Campus, Military Rd, Lismore, NSW 2480, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Haller', 'Affiliation': 'Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Cramer', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Dobos', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9103087']
2979,32987917,Abscisic Acid Treatment in Patients with Prediabetes.,"AIM


to evaluate the effects of abscisic acid (ABA), contained in dwarf peaches, on the regression of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) conditions.
MATERIALS AND METHODS


sixty-five patients with IFG or IGT were randomized to take ABA or placebo for 3 months. We evaluated: fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA 1c ), fasting plasma insulin (FPI), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile and high sensitivity C-reactive protein (Hs-CRP). At baseline, and after 3 months, all patients underwent an oral glucose tolerance test (OGTT), an euglycemic hyperinsulinemic clamp, and a glucagon test.
RESULTS


a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group. After 3 months, 26.7% of patients returned to a normal glycemic status in the ABA group versus zero patients in placebo group; 20.0% were classified as IFG and 53.3% as IGT in the nutraceutical group versus 33.3% and 63.3% in the placebo group. The M value was higher in the ABA group at the end of the treatment. Finally, Hs-CRP was reduced after 3 months of ABA consumption.
CONCLUSIONS


abscisic acid can be effective in ameliorating glyco-metabolic compensation and in reducing inflammatory status in patients with IFG or IGT.",2020,"RESULTS


a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group.","['patients with IFG or IGT', 'sixty-five patients with IFG or IGT', 'Patients with Prediabetes']","['abscisic acid', 'Abscisic Acid', 'placebo', 'oral glucose tolerance test (OGTT), an euglycemic hyperinsulinemic clamp, and a glucagon test', 'abscisic acid (ABA', 'ABA or placebo']","['impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) conditions', 'HbA 1c , FPG, PPG, FPI and HOMA-IR', 'M value', 'Hs-CRP', 'fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA 1c ), fasting plasma insulin (FPI), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile and high sensitivity C-reactive protein (Hs-CRP', 'normal glycemic status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0000843', 'cui_str': 'Abscisic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}]","[{'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",65.0,0.0269816,"RESULTS


a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Laboratory of Molecular Medicine, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Paola S', 'Initials': 'PS', 'LastName': 'Preti', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Novellino', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, 80131 Napoli, Italy.'}]",Nutrients,['10.3390/nu12102931']
2980,32987943,Postprandial Effect of Yogurt Enriched with Anthocyanins from Riceberry Rice on Glycemic Response and Antioxidant Capacity in Healthy Adults.,"The pigment of riceberry rice has been reported to contain anthocyanins which act as a free radical scavenger and inhibitor of carbohydrate digestive enzymes. Since the probiotic yogurt incorporated with the pigment of riceberry rice extract was previously developed, the present study was aimed to investigate the acute effect of riceberry rice yogurt consumption on postprandial glycemic response, antioxidant capacity, and subjective ratings in healthy adults. In a cross-over design, 19 healthy participants were randomized to consume 350 g of yogurt supplemented with 0.25%  (w/w)  riceberry rice extract or the control yogurt. Postprandial plasma glucose, antioxidant status, and subjective ratings were measured at fasting and intervals (0-3 h) after ingestion of yogurt. The primary outcome was glycemic response; the secondary outcomes were plasma antioxidant capacity. In comparison to the yogurt control, riceberry rice yogurt reduced plasma glucose concentration after 30 min of consumption. The incremental area under the curve (iAUC) was significantly lower after riceberry rice yogurt load than after the control yogurt load. The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively. Furthermore, the iAUCs for FRAP, TEAC, ORAC, and protein thiol were higher in riceberry yogurt consumption compared with the control yogurt (1.6-, 1.6-, 2.9-, and 1.9-fold, respectively). A decrease in iAUC for plasma malondialdehyde (MDA) concentration was also observed in the riceberry yogurt group. However, consumption of riceberry rice yogurt and control yogurt showed similar subjective rating scores of hunger, desire to eat, fullness, and satiety. In conclusion, acute consumption of riceberry rice yogurt suppressed postprandial glucose level and improved plasma antioxidant capacity in healthy volunteers.",2020,"The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively.","['Healthy Adults', '19 healthy participants', 'healthy adults', 'healthy volunteers']","['riceberry rice yogurt consumption', 'Anthocyanins from Riceberry Rice', 'consume 350 g of yogurt supplemented with 0.25%  (w/w)  riceberry rice extract or the control yogurt']","['plasma antioxidant capacity', 'Glycemic Response and Antioxidant Capacity', 'postprandial glycemic response, antioxidant capacity, and subjective ratings', 'incremental area under the curve (iAUC', 'iAUC for plasma malondialdehyde (MDA) concentration', 'plasma glucose concentration', 'plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC', 'postprandial glucose level', 'Postprandial plasma glucose, antioxidant status, and subjective ratings', 'subjective rating scores of hunger, desire to eat, fullness, and satiety', 'glycemic response']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C2702414', 'cui_str': 'rice allergenic extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4277707', 'cui_str': 'Oxygen Radical Absorbance Capacity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",19.0,0.0414961,"The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively.","[{'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Anuyahong', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Charoonsri', 'Initials': 'C', 'LastName': 'Chusak', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Thavaree', 'Initials': 'T', 'LastName': 'Thilavech', 'Affiliation': 'Department of Food Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sirichai', 'Initials': 'S', 'LastName': 'Adisakwattana', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}]",Nutrients,['10.3390/nu12102930']
2981,32988292,Efficacy of Melatonin for Sleep Disturbance in Children with Persistent Post-Concussion Symptoms: Secondary Analysis of a Randomized Controlled Trial.,"Sleep disturbances are commonly reported in children with persistent post-concussion symptoms (PPCS). Melatonin treatment is often recommended, yet supporting evidence is scarce. We aimed to evaluate the efficacy of treatment with melatonin for sleep disturbance in youth with PPCS following mild traumatic brain injury (mTBI). This article is a secondary analysis of a clinical trial of melatonin compared with placebo to treat PPCS. Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury were eligible. Exclusion criteria: significant medical/psychiatric history; previous concussion/mTBI within 3 months. Treatment groups were: placebo, melatonin 3 mg, or melatonin 10 mg. Primary outcome was change in SRPs measured using the Post-Concussion Symptom Inventory (PCSI) after 2 weeks of treatment. Secondary outcomes included change in actigraphy sleep efficiency, duration, onset latency, and wake-after-sleep-onset. Behavior was measured using Behaviour Assessment for Children (2nd edition). Seventy-two participants (mean age 14.0, standard deviation [SD] = 2.6) years; 60% female) with PPCS and significant sleep disturbance were included in the secondary analysis: placebo ( n  = 22); melatonin 3 mg ( n  = 25); melatonin 10 mg ( n  = 25). Sixty-four participants had actigraphy data. SRPs decreased across all groups over time with a significant effect of melatonin 3 mg (3.7; 95% confidence interval [CI]: 2.1, 5.4) compared with placebo (7.4; 95% CI: 4.2, 10.6) and melatonin 10 mg (6.4; 95% CI: 3.6, 9.2). Sleep duration increased in the melatonin 3 mg (43 min; 95% CI: 6, 93) and melatonin 10 mg groups (55 min; 95% CI: 5, 104) compared with placebo. A per protocol analysis demonstrated improved sleep efficiency in the melatonin 10 mg group ( p  = 0.029). No serious adverse events were reported. Depressive symptoms significantly decreased with melatonin 3 mg (-4.7; 95% CI: -9.2, -.2) but not with melatonin 10 mg (-1.4, 95% CI: -5.9, 3.2) treatment compared with placebo. Changes in cognition or behavior were otherwise not significantly different between treatment groups. Short-term melatonin is a well-tolerated treatment for sleep disturbance in youth with PPCS following mTBI. In this context, it may also be associated with a reduction in depressive symptoms.",2020,"Depressive symptoms significantly decreased with Melatonin 3mg (EMD=-4.7; 95%CI:-9.2,-.2) but not Melatonin 10mg (-1.4, 95%CIs:-5.9,3.2) treatment compared to placebo.","['youth with PPCS following mild traumatic brain injury (mTBI', 'Results Seventy-two participants (mean age 14.0(SD=2.6) years; 60% female) with PPCS and significant sleep disturbance', 'Youth (aged 8-18 years) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury were eligible', 'children with persistent post-concussion symptoms', 'children with persistent post-concussion symptoms (PPCS']","['placebo', 'Melatonin', 'placebo, Melatonin 3mg, or Melatonin']","['sleep efficiency', 'change in SRPs measured using the Post-Concussion Symptom Inventory (PCSI', 'Sleep disturbances', 'change in actigraphy sleep efficiency, duration, onset latency, and wake-after-sleep-onset', 'Sleep duration', 'sleep disturbance', 'Depressive symptoms', 'SRPs', 'Changes in cognition or behaviour', 'serious adverse events']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1124060', 'cui_str': 'Melatonin 3 MG'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.703472,"Depressive symptoms significantly decreased with Melatonin 3mg (EMD=-4.7; 95%CI:-9.2,-.2) but not Melatonin 10mg (-1.4, 95%CIs:-5.9,3.2) treatment compared to placebo.","[{'ForeName': 'Karen Maria', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': 'Child Health Research Centre, University of Queensland Faculty of Medicine and Biomedical Sciences, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Kirk', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Brooks', 'Affiliation': ""Department of Pediatrics, Clinical Neurosciences, and Psychology, Alberta Children's Hospital and University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Michael Joachim', 'Initials': 'MJ', 'LastName': 'Esser', 'Affiliation': 'Department of Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Zemek', 'Affiliation': ""Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Mikrogianakis', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'MacMaster', 'Affiliation': 'Department of Psychiatry and Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hutchison', 'Affiliation': 'Critical Care Medicine and Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Turley', 'Affiliation': ""Department of Pediatrics, Clinical Neurosciences, and Psychology, Alberta Children's Hospital and University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Cameron', 'Affiliation': 'Research Pharmacy, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Boyd', 'Affiliation': ""Children's Health Research Centre, University of Queensland, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Dewey', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}]",Journal of neurotrauma,['10.1089/neu.2020.7154']
2982,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND


Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS


33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS


Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION


HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
2983,33007851,Comparison of Skeletal and Dental Changes Obtained from a Tooth-Borne Maxillary Expansion Appliance Compared to the Damon System Assessed through a Digital Volumetric Imaging: A Randomized Clinical Trial.,"The purpose of this study was to evaluate and compare dental and skeletal changes associated with the Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT). Eighty-two patients, from The University of Alberta Orthodontic Clinic, were randomly allocated to either Group A or B. Patients in Group A received orthodontic treatment using the Damon brackets. Patients in Group B received treatment using the Hyrax (a type of RME) appliance. CBCT images were taken two times (baseline and after expansion). The AVIZO software was used to locate 18 landmarks (dental and skeletal) on sagittal, axial, and coronal slices of CBCT images. Comparison between two groups showed that transverse movement of maxillary first molars and premolars was much greater in the Hyrax group. The lateral movements of posterior teeth were associated with buccal tipping of crowns. No clinically significant difference in the vertical or anteroposterior direction between the two groups was noted. Alveolar bone next to root apex of maxillary first premolar and molar teeth showed clinically significant lateral movement in the Hyrax group only. The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.",2020,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"['Eighty-two patients, from The University of Alberta Orthodontic Clinic']","['Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT', 'orthodontic treatment using the Damon brackets', 'Digital Volumetric Imaging', 'Hyrax (a type of RME) appliance']","['vertical or anteroposterior direction', 'transverse movement of maxillary first molars and premolars', 'transverse expansion', 'lateral movements of posterior teeth']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1321060', 'cui_str': 'Transverse movement'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",82.0,0.0286724,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"[{'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gianoni-Capenakas', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Major', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Giseon', 'Initials': 'G', 'LastName': 'Heo', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103167']
2984,33007878,Distinct Effects of Acute Aerobic Exercise on Declarative Memory and Procedural Memory Formation.,"Objective:  To investigate the different effects of acute aerobic exercise on the formation of long-term declarative memory (DM) and procedural memory (PM).  Methods:  Twenty-two young men completed DM and PM tasks under three experimental conditions: pre-acquisition exercise, post-acquisition exercise, and no exercise (control). The DM task encompassed word learning, free recall tests both immediately and 1 h later, and a recognition test conducted 24 h after word learning. A serial reaction time task (SRTT) was utilized to assess exercise effects on PM. The SRTT included a sequence learning phase followed by sequence tests 1 h and 24 h later. The exercise program consisted of 30 min of moderate-intensity aerobic exercise.  Results:  In the DM task, compared to the control condition, pre-acquisition exercise, but not post-acquisition exercise, enhanced free recall performance significantly 1 h and 24 h later. The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition. In the PM task, we observed significantly reduced (improved) reaction times at the 24-h test in the post-acquisition exercise condition compared to in the control condition.  Conclusion:  Acute aerobic exercise may enhance long-term DM and PM via effects on different processing periods. For DM, exercise had a pronounced effect during the encoding period, whereas for PM, exercise was found to have an enhancing effect during the consolidation period.",2020,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,['Methods:  Twenty-two young men completed DM and PM tasks under three experimental conditions'],"['pre-acquisition exercise, post-acquisition exercise, and no exercise (control', 'Acute aerobic exercise', 'serial reaction time task (SRTT', 'acute aerobic exercise', 'Acute Aerobic Exercise', 'exercise program consisted of 30 min of moderate-intensity aerobic exercise']","['Declarative Memory and Procedural Memory Formation', 'formation of long-term declarative memory (DM) and procedural memory (PM', ' reaction times', ""target word recognition rate and discriminative index (d') of the recognition test"", 'free recall performance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0561782', 'cui_str': 'Procedural memory'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",22.0,0.0402269,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,"[{'ForeName': 'Xuru', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100691']
2985,33009665,"No ""Wearing-Off Effect"" Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long-Term Study.","OBJECTIVE


To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing-off effect).
BACKGROUND


The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine-associated disability. Wearing-off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications.
DESIGN AND METHODS


This was a long-term, 12-month, multicenter, randomized, double-blind, parallel-group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1-2 and weeks 3-4, between weeks 1-3 and week 4, and between weeks 1-2 and weeks 11-12 were calculated.
RESULTS


A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1-2 and weeks 3-4 or between weeks 1-3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%-42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter.
CONCLUSIONS


This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval.",2020,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"['1890 patients (CM, 1110; EM, 780 ) were enrolled', 'included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week Phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients']","['Fremanezumab', 'fremanezumab']","['mean weekly number of migraine days', 'average number of migraine days', 'mean weekly migraine days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",1890.0,0.0446177,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'The Headache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.'}, {'ForeName': 'Darko M', 'Initials': 'DM', 'LastName': 'Stevanovic', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortega', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",Headache,['10.1111/head.13994']
2986,32987838,Prognostic Value of the Pace of Tumor Progression as Assessed by Serial  18 F-FDG PET/CT Scan and Liquid Biopsy in Refractory Colorectal Cancer: The CORIOLAN Trial.,"INTRODUCTION


Decision making in refractory colorectal cancer (rCRC) is challenging, with limited data available to predict patient outcome. We conducted a study to assess the pace of cancer progression as a potential prognostic and decision tool.
METHODS


CORIOLAN was a prospective, single-center, single-arm trial recruiting refractory CRC patients with an ECOG performance status of ≤1 and an estimated life expectancy of ≥12 weeks. 18 fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT) scan and blood sample collection were carried out at baseline and after 2 weeks with no cancer treatment given between these timepoints. The primary objective was to evaluate the association between pace of cancer progression as defined by changes of the whole-body metabolically active tumor volume (WB-MATV) and overall survival (OS). Exploratory objectives included evaluation of the prognostic value of circulating cell-free DNA (cfDNA), circulating tumor cells (CTCs) and carcinoembryonic antigen (CEA).
RESULTS


47 eligible patients who had received a median number of 5 (range 2-8) prior treatments were enrolled. At the time of analysis, 45 deaths had occurred, with 26% of patients dying within 12 weeks. The median OS was 6.3 months (range 0.4-14.3). The median relative delta between WB-MATV at baseline and 2 weeks was +21%. Changes of WB-MATV, however, failed to predict OS (hazard ratio (HR) 1.3,  p  = 0.383). Similarly, no association was observed between changes of any of the circulating biomarkers investigated and prognosis. By contrast, high WB-MATV (4.2 versus 9.4 months; HR 3.1,  p  = 0.003), high CEA (4.4 versus 7.0 months; HR 1.9,  p  = 0.053), high cfDNA (4.7 versus 7.0 months; HR 2.2,  p  = 0.015) and high CTC count (3.3 versus 7.5 months; HR 6.5,  p  < 0.001) at baseline were associated with worse OS.
CONCLUSIONS


In this study, approximately 1 out of 4 refractory CRC patients who were judged to have a life expectancy >12 weeks actually died within 12 weeks. Baseline assessment of WB-MATV, cfDNA, CTCs and CEA, but not early change evaluation of the same, may help to refine patient prognostication and guide management decisions.",2020,"Changes of WB-MATV, however, failed to predict OS (hazard ratio (HR) 1.3,  p  = 0.383).","['refractory CRC patients with an ECOG performance status of ≤1 and an estimated life expectancy of ≥12 weeks', '47 eligible patients who had received a median number of 5 (range 2-8) prior treatments were enrolled', 'refractory colorectal cancer (rCRC', 'Refractory Colorectal Cancer', '4 refractory CRC patients who were judged to have a life expectancy >12 weeks actually died within 12 weeks']",['18 fluorodeoxyglucose positron emission tomography/computed tomography'],"['whole-body metabolically active tumor volume (WB-MATV) and overall survival (OS', 'high CTC count', 'pace of cancer progression', 'median relative delta', 'circulating cell-free DNA (cfDNA), circulating tumor cells (CTCs) and carcinoembryonic antigen (CEA', 'median OS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}]",47.0,0.0679347,"Changes of WB-MATV, however, failed to predict OS (hazard ratio (HR) 1.3,  p  = 0.383).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Camera', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Akin Telli', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Woff', 'Affiliation': 'Department of Nuclear Medicine, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Vandeputte', 'Affiliation': 'GUTS lab, Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Pashalina', 'Initials': 'P', 'LastName': 'Kehagias', 'Affiliation': 'GUTS lab, Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Guiot', 'Affiliation': 'Department of Nuclear Medicine, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Critchi', 'Affiliation': 'Department of Nuclear Medicine, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Wissam', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Bregni', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Trevisi', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pretta', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Senti', 'Affiliation': 'GUTS lab, Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'GUTS lab, Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Paraskevas', 'Initials': 'P', 'LastName': 'Gkolfakis', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Hoerner', 'Affiliation': 'Clinical Trial Conduct Unit (CTCU), Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Rothé', 'Affiliation': 'Breast cancer translational research laboratory, Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sclafani', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Flamen', 'Affiliation': 'Department of Nuclear Medicine, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Deleporte', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Hendlisz', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet-Université Libre de Bruxelles (ULB), 1000 Brussels, Belgium.'}]",Cancers,['10.3390/cancers12102752']
2987,32987876,Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial.,"BACKGROUND


The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy.
METHODS


This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay.
RESULTS


This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%,  p  = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%,  p  = 0.004), and clinically relevant POPF (8.3% vs. 46.2%,  p  = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453-207.870, p = 0.024).
CONCLUSION


Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.",2020,"POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%,  p  = 0.037).","['Pancreatic Fistula after Pancreatectomy', '53 patients, of whom 26 patients were in the']","['control group (thrombin-coated collagen patch', 'flowable hemostatic matrix', 'intervention group (flowable hemostatic matrix', 'Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix']","['risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay', 'incidence of POPF', 'safety and efficacy', 'POPF', 'clinically relevant POPF']","[{'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",26.0,0.127648,"POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%,  p  = 0.037).","[{'ForeName': 'Yejong', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Jae Hyung', 'Initials': 'JH', 'LastName': 'Ko', 'Affiliation': 'Regenerative Medicine Research Center, Dalim Tissen Co., Ltd., 31, Yeonhui-ro, Mapo-gu, Seoul 05505, Korea.'}, {'ForeName': 'Dae Ryong', 'Initials': 'DR', 'LastName': 'Kang', 'Affiliation': 'Department of Precision Medicine, Wonju College of Medicine, Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do 26493, Korea.'}, {'ForeName': 'Jun Hyeok', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Precision Medicine, Wonju College of Medicine, Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do 26493, Korea.'}, {'ForeName': 'Dae Wook', 'Initials': 'DW', 'LastName': 'Hwang', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Woohyung', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Si-Nae', 'Initials': 'SN', 'LastName': 'Park', 'Affiliation': 'Regenerative Medicine Research Center, Dalim Tissen Co., Ltd., 31, Yeonhui-ro, Mapo-gu, Seoul 05505, Korea.'}, {'ForeName': 'Ki-Byung', 'Initials': 'KB', 'LastName': 'Song', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Song Cheol', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103085']
2988,32988938,Comparing responses to public health and industry-funded alcohol harm reduction advertisements: an experimental study.,"OBJECTIVES


Conduct a head-to-head experimental test of responses to alcohol harm reduction advertisements developed by alcohol industry Social Aspects/Public Relations Organisations (SAPROs) versus those developed by public health (PH) agencies. We hypothesised that, on average, SAPRO advertisements would be less effective at generating motivation (H1) and intentions to reduce alcohol consumption (H2) but more effective at generating positive perceptions of people who drink (H3).
DESIGN


Online experiment with random assignment to condition.
PARTICIPANTS


2923 Australian adult weekly drinkers (49% high-risk drinkers) recruited from an opt-in online panel.
INTERVENTIONS


Participants viewed 3 of 83 advertisements developed by PH agencies (n=2174) or 3 of 28 advertisements developed by SAPROs (n=749).
PRIMARY OUTCOME MEASURES


Participants reported their motivation to reduce the amount of alcohol consumed; behave responsibly and/or not get drunk; and limit their drinking around/never supply to minors, as well as intentions to avoid drinking alcohol completely; reduce the number of drinking occasions; and reduce the amount of alcohol consumed per occasion. Participants also reported their perceptions of people who drink alcohol on six success-related items and four fun-related items.
RESULTS


Compared with drinkers exposed to PH advertisements, those exposed to SAPRO advertisements reported lower motivation to reduce the amount of alcohol consumed (β=-0.091, 95% CI -0.171 to -0.010), and lower odds of intending to avoid alcohol completely (OR=0.77, 0.63 to 0.94) and to reduce the amount of alcohol consumed per occasion (OR=0.82, 0.69 to 0.97). SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
CONCLUSIONS


The alcohol harm reduction advertisements produced by alcohol industry SAPROs that were tested in this study were not as effective at generating motivation and intentions to reduce alcohol consumption as those developed by PH organisations. These findings raise questions as to whether SAPROs should play a role in alcohol harm reduction efforts.",2020,"SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
","['n=2174) or 3 of 28 advertisements developed by SAPROs (n=749', '2923 Australian adult weekly drinkers (49% high-risk drinkers) recruited from an opt-in online panel']","['public health and industry-funded alcohol harm reduction advertisements', 'Participants viewed 3 of 83 advertisements developed by PH agencies']",['number of drinking occasions'],"[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",2923.0,0.0321565,"SAPRO advertisements generated more favourable fun-related perceptions of drinkers (β=0.095, 0.013 to 0.177).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia emily.brennan@cancervic.org.au.'}, {'ForeName': 'Danielle A J M', 'Initials': 'DAJM', 'LastName': 'Schoenaker', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Durkin', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Dunstone', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen G', 'Initials': 'HG', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Slater', 'Affiliation': 'School of Communication, Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035569']
2989,32988951,"Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.","INTRODUCTION


This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres.
METHODS AND ANALYSIS


Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.",2020,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


","['Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury', 'traumatic spinal cord injury', 'individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI']","['MyndMove therapy versus conventional therapy (CT', 'MyndMove neuromodulation therapy or CT', 'conventional therapy', 'MyndMove neuromodulation therapy']","[' (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events', 'efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore', 'quality of life as measured by the Spinal Cord Injury-Quality of Life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0763303', 'cui_str': ""N-bis(1-hydroxy-2-oxopropyl)-2'-deoxyguanosine""}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",60.0,0.134899,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Anderson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Wilson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Korupolu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': 'Centre for Neurology Studies, Health Tech Connex, Surrey, British Columbia, Canada.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Bowen', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Naaz', 'Initials': 'N', 'LastName': 'Kapadia', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Popovic', 'Affiliation': 'The KITE Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Musselman', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada Kristin.Musselman@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039650']
2990,32988969,A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor-Positive Breast Cancer.,"PURPOSE


To determine whether the androgen receptor (AR) inhibitor, enzalutamide, improves effectiveness of endocrine therapy (ET) in hormone receptor-positive (HR + ) breast cancer.
PATIENTS AND METHODS


In this phase II trial, patients with HR + /HER2 normal advanced/metastatic breast cancer were randomized 1:1 to exemestane 25 mg with placebo or exemestane 50 mg with enzalutamide 160 mg daily (NCT02007512). Two parallel cohorts enrolled patients with 0 (cohort 1) or 1 (cohort 2) prior ET for advanced disease. Progression-free survival (PFS) was the primary endpoint in the intent-to-treat (ITT) population of each cohort. Biomarkers were evaluated in an exploratory analysis.
RESULTS


Overall, 247 patients were randomized (cohort 1,  n  = 127 and cohort 2,  n  = 120). PFS was not improved in either cohort of the ITT population [HR, 0.82 (95% confidence interval (CI), 0.54-1.26);  P  = 0.3631 for cohort 1 and HR, 1.02 (95% CI, 0.66-1.59);  P  = 0.9212 for cohort 2]. In cohort 1, high levels of AR mRNA were associated with greater benefit of enzalutamide ( P   interaction  = 0.0048). This effect was particularly apparent in patients with both high levels of AR mRNA and low levels of ESR1 mRNA [HR, 0.24 (95% CI, 0.10-0.60);  P  = 0.0011]. The most common any grade adverse events in the enzalutamide arms were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2.
CONCLUSIONS


Enzalutamide with exemestane was well tolerated. While PFS was not improved by the addition of enzalutamide to exemestane in an unselected population, ET-naïve patients with high AR mRNA levels, particularly in combination with low ESR1 mRNA levels, may benefit from enzalutamide with exemestane.",2020,PFS was not improved in either cohort of the ITT population (hazard ratio [HR] 0.82 [95% CI 0.54-1.26];  P =0.3631 for cohort 1; HR 1.02,"['247 patients were randomized (cohort 1, n=127; cohort 2, n=120', 'patients with HR+/HER2-normal advanced/metastatic breast cancer', 'Patients With Hormone Receptor-positive Breast Cancer', 'Two parallel cohorts enrolled patients with 0 (cohor 1) or 1 (cohort 2) prior ET for advanced disease', 'patients with both high AR mRNA and low levels of ESR1 mRNA (HR 0.24']","['exemestane 25 mg with placebo or exemestane 50 mg with enzalutamide', 'Exemestane With or Without Enzalutamide', 'enzalutamide', 'androgen receptor (AR) inhibitor enzalutamide', 'exemestane', 'Enzalutamide with exemestane', 'Placebo', 'endrocrine therapy (ET']","['grade adverse events', 'Progression-free survival (PFS', 'nausea', 'tolerated', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C4517441', 'cui_str': '0.24'}]","[{'cui': 'C1125968', 'cui_str': 'exemestane 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",247.0,0.247884,PFS was not improved in either cohort of the ITT population (hazard ratio [HR] 0.82 [95% CI 0.54-1.26];  P =0.3631 for cohort 1; HR 1.02,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts. ikrop@partners.org.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Traina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Holmes', 'Affiliation': 'Texas Oncology-Houston Memorial City, US Oncology Network, The Woodlands, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garcia-Estevez', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Florida Cancer Specialists, Fort Myers, Florida.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Department of Oncology Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zamagni', 'Affiliation': 'Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Bologna, Italy.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Morris', 'Affiliation': 'Beaumont Hospital and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'University of Tennessee, West Cancer Center, Memphis, Tennessee.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Nottingham University Hospital, City Campus, Nottingham, England, United Kingdom.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Gucalp', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': 'Nuovo Ospedale di Prato, Tuscany, Italy.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, Illinois.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Sica', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Trudeau', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Denka', 'Initials': 'D', 'LastName': 'Markova', 'Affiliation': 'Formerly of Pfizer Inc., San Francisco, California.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Tarazi', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Pfizer Inc., San Francisco, California.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Kelly', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology, PLLC, Nashville, Tennessee.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1693']
2991,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND


Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS


The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS


INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
2992,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE


This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD


CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS


The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION


This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
2993,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND


Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS


We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS


The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS


IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
2994,32992184,Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Local vibration can improve balance problems of individuals with stroke when applied to the plantar region.
AIMS


This study aimed to determine the immediate effect of local vibration applied to the plantar region on fall risk and postural stability in patients with stroke.
STUDY DESIGN


Randomized controlled study.
METHODS


30 patients (23 male,7 female) with stroke were randomized to either vibration (n = 15; 58.47 ± 8.23 years) or control (n = 15; 58.27 ± 9.50 years) groups. Before and after the intervention, the patients were evaluated using a Biodex Balance System. Local vibration was applied to the plantar region of two feet in the supine position using a vibration device for a total of 15 min to the individuals in the vibration group. While the patients in the placebo group were in the supine position, the device was brought into contact and no vibration was applied to the plantar region of two feet for 15 min.
RESULTS


While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05). Furthermore, significant improvements occurred in the SD values of the postural stability expressing postural oscillation in the vibration group (p < 0.05).
CONCLUSION


As a result of local vibration applied to the plantar region, immediate (within 5 min) significant improvements in postural stability and fall risk values were detected.",2020,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","['individuals with stroke', '30 patients (23 male,7 female) with stroke', 'Stroke Patients', 'patients with stroke']","['placebo', 'local vibration', 'Plantar Vibration', 'vibration']","['fall risk and postural stability', 'SD values of the postural stability expressing postural oscillation', 'postural stability and fall risk', 'postural stability and fall risk values', 'Fall Risk and Postural Stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",30.0,0.0194722,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","[{'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Önal', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey. Electronic address: fztbirolonal@gmail.com.'}, {'ForeName': 'Gülten', 'Initials': 'G', 'LastName': 'Karaca', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Ankara Memorial Hospital, Ankara, Turkey. Electronic address: gulten2013@yahoo.com.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Sertel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Kırıkkale University Faculty of Health Sciences, Kırıkkale, Turkey. Electronic address: fzt_meralaksehir@hotmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105324']
2995,32992871,High-Intensity Interval Training Is Effective at Increasing Exercise Endurance Capacity and Is Well Tolerated by Adults with Cystic Fibrosis.,"BACKGROUND


To optimize outcomes in people with cystic fibrosis (CF), guidelines recommend 30 to 60 min of moderate-intensity aerobic exercise on most days. Accumulating this volume of exercise contributes importantly to the substantial treatment burden associated with CF. Therefore, the main aim of this study was to investigate the effects of low-volume high-intensity interval training (HIIT) on exercise capacity in people with CF.
METHODS


This randomized controlled trial included people with CF aged ≥15 years, who were allocated to either eight weeks of thrice-weekly 10-min sessions of HIIT (experimental group) or eight weeks of weekly contact (control group). Before and after the intervention period, participants completed measurements of time to symptom limitation (T lim ) during a constant work rate cycle ergometry test (primary outcome), and maximal work rate (W max ) during a ramp-based cycle ergometry test and health-related quality of life (HRQoL).
RESULTS


Fourteen participants (median (IQR) age 31 (28, 35) years, forced expiratory volume in 1 second (FEV 1 ) 61 (45, 80) % predicted) were included (seven in each group). Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max  ( p  = 0.017 for both) and in the physical function domain of HRQoL ( p  = 0.03). No other between-group differences were demonstrated. Mild post-exercise muscle soreness was reported on a single occasion by four participants. Overall, participants attended 93% of all HIIT sessions.
DISCUSSION


Eight weeks of low-volume (i.e., 30-min/week) HIIT produced gains in exercise capacity and self-reported physical function and was well tolerated by people with CF.",2020,"Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max  ( p  = 0.017 for both) and in the physical function domain of HRQoL ( p  = 0.03).","['people with CF aged ≥15 years', 'Adults with Cystic Fibrosis', 'Fourteen participants (median (IQR) age 31 (28, 35) years, forced expiratory volume in 1 second (FEV 1 ) 61 (45, 80) % predicted) were included (seven in each group', 'people with CF', 'people with cystic fibrosis (CF']","['low-volume high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['time to symptom limitation (T lim ) during a constant work rate cycle ergometry test (primary outcome), and maximal work rate (W max ) during a ramp-based cycle ergometry test and health-related quality of life (HRQoL', 'magnitude of change in T lim , W max', 'exercise capacity', 'exercise capacity and self-reported physical function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.114533,"Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max  ( p  = 0.017 for both) and in the physical function domain of HRQoL ( p  = 0.03).","[{'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Sawyer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Institute of Health Research, Fremantle Campus, University of Notre Dame Australia, Fremantle, WA 6160, Australia.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9103098']
2996,32992879,"Cognitive Training Deep Dive: The Impact of Child, Training Behavior and Environmental Factors within a Controlled Trial of Cogmed for Fragile X Syndrome.","Children with fragile X syndrome (FXS) exhibit deficits in a variety of cognitive processes within the executive function domain. As working memory (WM) is known to support a wide range of cognitive, learning and adaptive functions, WM computer-based training programs have the potential to benefit people with FXS and other forms of intellectual and developmental disability (IDD). However, research on the effectiveness of WM training has been mixed. The current study is a follow-up ""deep dive"" into the data collected during a randomized controlled trial of Cogmed (Stockholm, Sweden) WM training in children with FXS. Analyses characterized the training data, identified training quality metrics, and identified subgroups of participants with similar training patterns. Child, parent, home environment and training quality metrics were explored in relation to the clinical outcomes during the WM training intervention. Baseline cognitive level and training behavior metrics were linked to gains in WM performance-based assessments and also to reductions in inattention and other behaviors related to executive functioning during the intervention. The results also support a recommendation that future cognitive intervention trials with individuals with IDD such as FXS include additional screening of participants to determine not only baseline feasibility, but also capacity for training progress over a short period prior to inclusion and randomization. This practice may also better identify individuals with IDD who are more likely to benefit from cognitive training in clinical and educational settings.",2020,Baseline cognitive level and training behavior metrics were linked to gains in WM performance-based assessments and also to reductions in inattention and other behaviors related to executive functioning during the intervention.,"['children with FXS', 'individuals with IDD', 'Children with fragile X syndrome (FXS']","['Cogmed (Stockholm, Sweden', 'Cognitive Training Deep Dive', 'WM training']",['Baseline cognitive level and training behavior metrics'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0012823', 'cui_str': 'Diving'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",,0.0247031,Baseline cognitive level and training behavior metrics were linked to gains in WM performance-based assessments and also to reductions in inattention and other behaviors related to executive functioning during the intervention.,"[{'ForeName': 'Haleigh', 'Initials': 'H', 'LastName': 'Scott', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}, {'ForeName': 'Danielle J', 'Initials': 'DJ', 'LastName': 'Harvey', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California Davis School of Medicine, Davis, CA 95616, USA.'}, {'ForeName': 'Yueju', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California Davis School of Medicine, Davis, CA 95616, USA.'}, {'ForeName': 'Yingratana A', 'Initials': 'YA', 'LastName': 'McLennan', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}, {'ForeName': 'Cindy K', 'Initials': 'CK', 'LastName': 'Johnston', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shickman', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Piven', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Schweitzer', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hessl', 'Affiliation': 'MIND Institute, University of California Davis Medical Center, Sacramento, CA 95817, USA.'}]",Brain sciences,['10.3390/brainsci10100671']
2997,32992927,Canan Outdoor Multisurface Terrain Enhance the Effects of Fall Prevention Exercise in Older Adults? A Randomized Controlled Trial.,"Walking on complex surface conditions in outdoor environments is important for active aging. This study aimed at examining whether fall prevention exercise integrated with an outdoor multisurface terrain compared with indoor solid ground was more beneficial for older adults. Twenty-two older nursing home residents were randomly assigned to outdoor multisurface terrain ( n  = 11, 79.5 ± 2.1 years) or indoor solid ground ( n  = 11, 78.8 ± 5.2 years) groups. Training occurred five times per week (30 min) for 3 weeks. The following performance test outcomes were measured: 10 m walk test (10 mWT), multisurface terrain walk test (MTWT), 2 min walk test (2 MWT), timed up and go test (TUGT), single-leg standing test with eyes open (SLSTEO), single-leg standing test with eyes closed (SLSTEC), and closed cycles test (CCT). Compared with baseline, the outdoor multisurface terrain training significantly improved performance in all tests ( p  < 0.01). The improvements of the outdoor multisurface terrain group after intervention were significantly higher than those of the indoor solid group in the 10 mWT ( p  = 0.049), MTWT ( p  = 0.02), and 2 MWT ( p  = 0.000). Exercise combined with outdoor multisurface terrain training may be an efficacious approach and a feasible environmental intervention for fall prevention in older adults.",2020,"Compared with baseline, the outdoor multisurface terrain training significantly improved performance in all tests ( p  < 0.01).","['older adults', 'Older Adults', ' n  = 11, 79.5 ± 2.1 years) or indoor solid ground ( n  = 11, 78.8 ± 5.2 years) groups', 'Twenty-two older nursing home residents']","['Fall Prevention Exercise', 'outdoor multisurface terrain', 'Exercise combined with outdoor multisurface terrain training']","['10 m walk test (10 mWT), multisurface terrain walk test (MTWT), 2 min walk test (2 MWT), timed up and go test (TUGT), single-leg standing test with eyes open (SLSTEO), single-leg standing test with eyes closed (SLSTEC), and closed cycles test (CCT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}]",22.0,0.0265237,"Compared with baseline, the outdoor multisurface terrain training significantly improved performance in all tests ( p  < 0.01).","[{'ForeName': 'Tong-Yue', 'Initials': 'TY', 'LastName': 'Zhou', 'Affiliation': 'School of Architecture, State Key Laboratory of Subtropical Building Science, South China University of Technology, Guangzhou 501640, China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Yuan', 'Affiliation': 'School of Architecture, State Key Laboratory of Subtropical Building Science, South China University of Technology, Guangzhou 501640, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Ma', 'Affiliation': 'School of Physical Education, South China University of Technology, Guangzhou 501640, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17197023']
2998,33016883,Expanding Access to Perinatal Depression Treatment in Kenya Through Automated Psychological Support: Development and Usability Study.,"BACKGROUND


Depression during pregnancy and in the postpartum period is associated with poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings; however, there are significant barriers to scale-up. We address this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
OBJECTIVE


This prepilot study aims to gather preliminary data on the Healthy Moms perinatal depression intervention to learn how to build and test a more robust service.
METHODS


We conducted a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya. We invited these women to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants were randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. We prompted participants to rate their mood via SMS text messaging every 3 days during the baseline and intervention periods, and we used these preliminary repeated measures data to fit a linear mixed-effects model of response to treatment. We also reviewed system logs and conducted in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability.
RESULTS


We invited 647 women to learn more about Zuri: 86 completed our automated SMS screening and 41 enrolled in the study. Most of the enrolled women submitted at least 3 mood ratings (31/41, 76%) and sent at least 1 message to Zuri (27/41, 66%). A third of the sample engaged beyond registration (14/41, 34%). On average, women who engaged post registration started 3.4 (SD 3.2) Healthy Moms sessions and completed 3.1 (SD 2.9) of the sessions they started. Most interviewees who tried Zuri reported having a positive attitude toward the service and expressed trust in Zuri. They also attributed positive life changes to the intervention. We estimated that using this alpha version of Zuri may have led to a 7% improvement in mood.
CONCLUSIONS


Zuri is feasible to deliver via SMS and was acceptable to this sample of pregnant women and new mothers. The results of this prepilot study will serve as a baseline for future studies in terms of recruitment, data collection, and outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/11800.",2020,"This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
","['women and their children', 'women who engaged post registration started 3.4 (SD 3.2', '647 women to learn more about Zuri: 86 completed our automated SMS screening and 41 enrolled in the study', 'pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya', 'pregnant women and new mothers']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]",[],[],647.0,0.171359,"This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
","[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Green', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Yihuan', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Sathyanath', 'Initials': 'S', 'LastName': 'Rajasekharan', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rauws', 'Affiliation': 'X2AI, San Francisco, CA, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Joerin', 'Affiliation': 'X2AI, San Francisco, CA, United States.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kwobah', 'Affiliation': 'Moi Teaching and Referral Hospital, Eldoret, Kenya.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Musyimi', 'Affiliation': 'Africa Mental Health Research and Training Foundation, Nairobi, Kenya.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Chaya', 'Initials': 'C', 'LastName': 'Bhat', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Mulinge', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Eve S', 'Initials': 'ES', 'LastName': 'Puffer', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}]",JMIR formative research,['10.2196/17895']
2999,33011207,Randomised trial of external-beam radiotherapy alone or with high-dose-rate brachytherapy for prostate cancer: Mature 12-year results.,"BACKGROUND AND PURPOSE


A randomised phase-III trial compared external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb) in localised prostate adenocarcinoma. Previous analysis, at median follow up of 85 months, demonstrated improved relapse free survival (RFS) with EBRT + HDR-BTb. This data has now been updated with a median follow up of 131 months.
MATERIALS AND METHODS


From December 1997 to August 2005, patients were assigned either to EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 × 8·5 Gy over 24 h. The primary endpoint was RFS defined by a PSA rise ≥2.0 µg/l above nadir, clinical progression or death. Actuarial survival rates and Hazard Ratios (HRs) were calculated using the Kaplan-Meier method and Cox's Proportional Hazard Model, respectively. Secondary endpoints were overall survival (OS), urinary and bowel toxicity.
RESULTS


One hundred and six patients received EBRT alone and 110 EBRT + HDR-BTb. Median time to relapse was 137 months in the HDR-BTb arm compared to 82 months for EBRT alone (p = 0·01). A 27% risk of recurrence with EBRT alone was observed (p = 0·001), resulting in a 21% improvement in RFS at 12 years with EBRT + HDR-BTb. In multivariate analysis treatment arm, risk category and no androgen deprivation therapy were significant covariates for risk of relapse. Differences in overall survival were not significant.
CONCLUSION


At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.",2020,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"['localised prostate adenocarcinoma', 'prostate cancer', '106 patients received', 'From December 1997 to August 2005, patients']","['external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb', 'EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 x 8·5 Gy over 24h', 'EBRT alone and 110 EBRT+HDR-BTb', 'external-beam radiotherapy alone or with high-dose-rate brachytherapy']","['overall survival (OS), urinary and bowel toxicity', 'overall survival', 'RFS defined by a PSA rise ≥ 2.0µg/l above nadir, clinical progression or death', 'severe late urinary and bowel events and urethral strictures', 'relapse free survival (RFS', 'Actuarial survival rates and Hazard Ratios (HRs', 'Median time to relapse', 'RFS']","[{'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730225', 'cui_str': '1997'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0962728,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK; University of Manchester, UK. Electronic address: peterhoskin@nhs.net.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rojas', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ostler', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bryant', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Gerry J', 'Initials': 'GJ', 'LastName': 'Lowe', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.047']
3000,33012017,"Photobiomodulation is effective in oral lichen planus: A randomized, controlled, double-blind study.","OBJECTIVES


To compare the efficacy of photobiomodulation to that of topical clobetasol 0.05% in patients with symptomatic oral lichen planus (OLP).
SUBJECTS


Thirty-four patients with symptomatic OLP were randomly allocated into two groups: (a) the Control group (n = 17), application of topical clobetasol propionate 0.05% three times a day for 30 consecutive days with laser placebo applied twice a week to mask the treatment, and (b) the photobiomodulation group (n = 17), laser application twice a week, totalling 8 sessions, and gel placebo for 30 consecutive days to mask the treatment. Evaluations were performed once a week during treatment and 30, 60 and 90 days after treatment. The following parameters were evaluated: pain, clinical scores, clinical resolution and recurrence rate.
RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up. Both the Control and photobiomodulation groups presented similar clinical resolution and recurrence rates. Most importantly, no difference was observed between treatments during treatment and follow-up.
CONCLUSIONS


These findings indicate that photobiomodulation twice a week is as effective as corticoid therapy in treating oral lichen planus. Moreover, photobiomodulation is a safe and non-invasive therapy with the remarkable advantage of no adverse effects.",2020,"RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up.","['Thirty-four patients with symptomatic OLP', 'patients with symptomatic oral lichen planus (OLP']","['Control group (n=17), application of topical clobetasol propionate', 'laser placebo', 'Photobiomodulation', 'photobiomodulation group (n=17), laser application twice a week, totalling 8 sessions, and gel placebo']","['clinical resolution and recurrence rates', 'clinical scores', 'pain, clinical scores, clinical resolution and recurrence rate', 'pain']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0055895', 'cui_str': 'Clobetasol propionate'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",34.0,0.0601029,"RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up.","[{'ForeName': 'Elza P', 'Initials': 'EP', 'LastName': 'Ferri', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Karen R L', 'Initials': 'KRL', 'LastName': 'Cunha', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Clery S', 'Initials': 'CS', 'LastName': 'Abboud', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'de Barros Gallo', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'de Sousa Sobral', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Fatima Teixeira da Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina R T', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Adriana L-D-S', 'Initials': 'AL', 'LastName': 'Franco', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Maria Fernanda Setúbal D', 'Initials': 'MFSD', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}]",Oral diseases,['10.1111/odi.13662']
3001,33012083,Oral mucositis after tacrolimus/sirolimus or cyclosporine/methotrexate as graft-versus-host disease prophylaxis.,"OBJECTIVES


To determine whether treatment with tacrolimus plus sirolimus (Tac/Sir) as a prophylaxis for graft-versus-host disease worsens severe oral mucositis and delays healing compared to cyclosporine plus methotrexate (CsA/Mtx) following haematopoietic stem cell transplantation.
SUBJECTS AND METHODS


The study comprised 141 patients: 73 randomized to receive Tac/Sir and 68 to receive CsA/Mtx. The oral mucositis assessment scale and toxicity grading according to WHO were used to assess the severity, peak and duration of oral mucositis from the day -3 to day 24 post-transplant.
RESULTS


Eighty-seven patients developed oral mucositis in the first 24 days post-transplant. No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed. The peak oral mucositis score occurred on day 10 in both groups. Although oral mucositis scores had returned to baseline in the CsA/Mtx group on day 24 post-transplant, no significant difference compared with the Tac/Sir group was found.
CONCLUSIONS


The introduction of tacrolimus/sirolimus as a graft-versus-host disease prophylaxis in haematopoietic stem cell transplantation increased neither the incidence nor severity of oral mucositis compared with cyclosporine/methotrexate. Furthermore, oral mucositis healing was not prolonged and followed the same time pattern as cyclosporine/methotrexate.",2020,No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed.,['141 patients: 73 randomized to'],"['cyclosporine/methotrexate', 'tacrolimus plus sirolimus (Tac/Sir', 'tacrolimus/sirolimus', 'tacrolimus/sirolimus or cyclosporine/methotrexate', 'receive Tac/Sir and 68, to receive CsA/Mtx', 'cyclosporine plus methotrexate (CsA/Mtx']","['Oral mucositis', 'oral mucositis severity', 'oral mucositis scores', 'peak oral mucositis score', 'oral mucositis healing', 'severity, peak, and duration of oral mucositis', 'oral mucositis', 'oral mucositis assessment scale and toxicity grading']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",141.0,0.0188875,No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Garming Legert', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Ringdén', 'Affiliation': 'Department of Clinical Sciences, Intervention and Technology, Translational cell therapy research group, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': 'Department of Medical Sciences, Uppsala University and KFUE, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Törlén', 'Affiliation': 'Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mattsson', 'Affiliation': 'Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dahllöf', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}]",Oral diseases,['10.1111/odi.13663']
3002,32996010,"Consequences of Supraphysiological Dialysate Magnesium on Arterial Stiffness, Hemodynamic Profile, and Endothelial Function in Hemodialysis: A Randomized Crossover Study Followed by a Non-Controlled Follow-Up Phase.","INTRODUCTION


Increasing dialysate magnesium (D-Mg 2+ ) appears to be an intriguing strategy to obtain cardiovascular benefits in subjects with end-stage kidney disease (ESKD) on hemodialysis. To date, however, hemodialysis guidelines do not suggest to increase D-Mg 2+  routinely set at 0.50 mmol/L.
METHODS


A randomized 4-week crossover study aimed at investigating the consequences of increasing D-Mg 2+  from 0.50 to 0.75 mmol/L on arterial stiffness, hemodynamic profile, and endothelial function in subjects undergoing hemodialysis. The long-term effect of higher D-Mg 2+  on mineral metabolism markers was investigated in a 6-month follow-up. Data were analyzed by linear mixed models for repeated measures.
RESULTS


Data of 39 patients were analyzed. Pulse wave velocity and pulse pressure significantly decreased on the higher D-Mg 2+  compared with the standard one by - 0.91 m/s (95% confidence interval - 1.52 to - 0.29; p = 0.01) and - 9.61 mmHg (- 18.89 to - 0.33, p = 0.04), respectively. A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed. No period or carryover effects were observed. During the long-term follow-up phase the higher D-Mg 2+  significantly increased ionized and total serum Mg (respectively from 0.54 to 0.64 and from 0.84 to 1.07 mmol/L; mean percentage change from baseline to follow-up + 21% and + 27%; p ≤ 0.001), while parathormone (PTH) decreased significantly (from 36.6 to 34.4 pmol/L; % change - 11%, p = 0.03).
CONCLUSIONS


Increasing dialysate magnesium improves vascular stiffness in subjects undergoing maintenance hemodialysis. The present findings merit a larger trial to evaluate the effects of 0.75 mmol/L D-Mg 2+  on major clinical outcomes.
TRIAL REGISTRATION


The study was retrospectively registered on the ISRCTN registry (ISRCTN 74139255) on 18 June 2020.",2020,"A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed.","['Hemodialysis', 'subjects with end-stage kidney disease (ESKD) on hemodialysis', '39 patients were analyzed', 'subjects undergoing hemodialysis', 'subjects undergoing maintenance hemodialysis']","['dialysate magnesium', 'Supraphysiological Dialysate Magnesium', 'increasing D-Mg 2+  from 0.50 to 0.75\xa0mmol/L']","['carryover effects', 'mineral metabolism markers', 'parathormone (PTH', 'arterial stiffness, hemodynamic profile, and endothelial function', 'ionized and total serum Mg', 'Pulse wave velocity and pulse pressure', 'systolic blood pressure', 'vascular stiffness', 'Arterial Stiffness, Hemodynamic Profile, and Endothelial Function']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",39.0,0.0276237,"A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed.","[{'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Del Giorno', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. rosaria.delgiorno@eoc.ch.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Lavorato Hadjeres', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Kevyn', 'Initials': 'K', 'LastName': 'Stefanelli', 'Affiliation': 'Department of Social Sciences and Economics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Allegra', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zapparoli', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Lazarevic', 'Initials': 'L', 'LastName': 'Predrag', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berwert', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gabutti', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. luca.gabutti@eoc.ch.'}]",Advances in therapy,['10.1007/s12325-020-01505-9']
3003,32996442,Effectiveness of a housing support team intervention with a recovery-oriented approach on hospital and emergency department use by homeless people with severe mental illness: a randomised controlled trial.,"AIMS


Many people who are homeless with severe mental illnesses are high users of healthcare services and social services, without reducing widen health inequalities in this vulnerable population. This study aimed to determine whether independent housing with mental health support teams with a recovery-oriented approach (Housing First (HF) program) for people who are homeless with severe mental disorders improves hospital and emergency department use.
METHODS


We did a randomised controlled trial in four French cities: Lille, Marseille, Paris and Toulouse. Participants were eligible if they were 18 years or older, being absolutely homeless or precariously housed, with a diagnosis of schizophrenia (SCZ) or bipolar disorder (BD) and were required to have a high level of needs (moderate-to-severe disability and past hospitalisations over the last 5 years or comorbid alcohol or substance use disorder). Participants were randomly assigned (1:1) to immediate access to independent housing and support from the Assertive Community Treatment team (social worker, nurse, doctor, psychiatrist and peer worker) (HF group) or treatment as usual (TAU group) namely pre-existing dedicated homeless-targeted programs and services. Participants and interviewers were unmasked to assignment. The primary outcomes were the number of emergency department (ED) visits, hospitalisation admissions and inpatient days at 24 months. Secondary outcomes were recovery (Recovery Assessment Scale), quality of life (SQOL and SF36), mental health symptoms, addiction issues, stably housed days and cost savings from a societal perspective. Intention-to-treat analysis was performed.
RESULTS


Eligible patients were randomly assigned to the HF group (n = 353) or TAU group (n = 350). No differences were found in the number of hospital admissions (relative risk (95% CI), 0.96 (0.76-1.21)) or ED visits (0.89 (0.66-1.21)). Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)). The HF group exhibited higher housing stability (difference in slope, 116 (103-128)) and higher scores for sub-dimensions of S-QOL scale (psychological well-being and autonomy). No differences were found for physical composite score SF36, mental health symptoms and rates of alcohol or substance dependence. Mean difference in costs was €-217 per patient over 24 months in favour of the HF group. HF was associated with cost savings in healthcare costs (RR 0.62(0.48-0.78)) and residential costs (0.07 (0.05-0.11)).
CONCLUSION


An immediate access to independent housing and support from a mental health team resulted in decreased inpatient days, higher housing stability and cost savings in homeless persons with SCZ or BP disorders.",2020,Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)).,"['people who are homeless with severe mental disorders improves hospital and emergency department use', 'Eligible patients', 'four French cities: Lille, Marseille, Paris and Toulouse', 'people who are homeless with severe mental illnesses', 'homeless persons with SCZ or BP disorders', 'homeless people with severe mental illness', 'Participants were eligible if they were 18 years or older, being absolutely homeless or precariously housed, with a diagnosis of schizophrenia (SCZ) or bipolar disorder (BD) and were required to have a high level of needs (moderate-to-severe disability and past hospitalisations over the last 5 years or comorbid alcohol or substance use disorder']","['immediate access to independent housing and support from the Assertive Community Treatment team (social worker, nurse, doctor, psychiatrist and peer worker) (HF group) or treatment as usual (TAU group) namely pre-existing dedicated homeless-targeted programs and services', 'HF', 'housing support team intervention with a recovery-oriented approach', 'housing with mental health support teams with a recovery-oriented approach (Housing First (HF) program', 'TAU']","['physical composite score SF36, mental health symptoms and rates of alcohol or substance dependence', 'cost savings in healthcare costs', 'number of hospital admissions', 'number of emergency department (ED) visits, hospitalisation admissions and inpatient days at 24 months', 'housing stability and cost savings', 'residential costs', 'recovery (Recovery Assessment Scale), quality of life (SQOL and SF36), mental health symptoms, addiction issues, stably housed days and cost savings from a societal perspective', 'housing stability', 'Mean difference in costs', 'higher scores for sub-dimensions of S-QOL scale (psychological well-being and autonomy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.227089,Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fond', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000785']
3004,32996592,"Local Transdermal Delivery of Telapristone Acetate Through Breast Skin, Compared With Oral Treatment: A Randomized Double-Blind, Placebo-Controlled Phase II Trial.","Oral breast cancer prevention medications entail systemic exposure, limiting acceptance by high-risk women. Delivery through the breast skin, although an attractive alternative, requires demonstration of drug distribution throughout the breast. We conducted a randomized double-blind, placebo-controlled phase II clinical trial comparing telapristone acetate, a progesterone receptor antagonist, administered orally (12 mg/day) or transdermally (12 mg/breast) for 4 ± 1 weeks to women planning mastectomy. Plasma and tissue concentrations, measured at five locations in the mastectomy specimen using liquid chromatography tandem mass spectrometry were compared. In 60 evaluable subjects, median drug concentration (ng/g tissue) was 103 (interquartile range (IQR): 46.3-336) in the oral vs. 2.82 (IQR: 1.4-5.5) in the transdermal group. Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2   = 0.88, P = 0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (P < 0.0001). Other skin-penetrant drugs should be tested for breast cancer prevention.",2020,"Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2  =0.88, p=0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (p<0.0001).","['60 evaluable subjects, median drug concentration (ng/g tissue) was 103 (IQR: 46.3-336) in the oral vs 2.82 (IQR: 1.4-5.5) in the transdermal group', 'high risk women']","['placebo', 'telapristone acetate', 'telapristone acetate (TPA), a progesterone receptor (PR) antagonist']",['Plasma and tissue concentrations'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C2745478', 'cui_str': 'AM103'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3501648', 'cui_str': 'telapristone acetate'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.134135,"Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2  =0.88, p=0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (p<0.0001).","[{'ForeName': 'Oukseub', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pilewskie', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Karlan', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Tull', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benante', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Blanco', 'Affiliation': 'Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Helenowski', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Shivangi', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hosseini', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bethke', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Muzzio', 'Affiliation': 'Analytical Chemistry Division, Illinois Institute of Technology Research Institute, Chicago, Illinois, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Troester', 'Affiliation': 'Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Dimond', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Perloff', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2041']
3005,32996893,"Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial.","BACKGROUND


Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM.
OBJECTIVE


This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level.
METHODS


A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used.
RESULTS


At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; -3.5, 95% CI -7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0).
CONCLUSIONS


Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02379078; https://clinicaltrials.gov/ct2/show/NCT02379078.",2020,"Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0).
","['Patients With Diabetes', 'Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario']","['provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later', 'MyDiabetesPlan', 'MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm', 'MyDiabetesPlan, a Web-Based Patient Decision Aid', 'static generic Diabetes Canada resources']","['decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care', 'individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM', 'patient assessment of chronic illness care', 'Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care', 'total decisional conflicts', 'diabetes distress or health-related quality of life', 'decision quality and chronic illness care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.157431,"Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0).
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""St. Michael's Hospital (Unity Health Toronto), Toronto, ON, Canada.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': ""St. Michael's Hospital (Unity Health Toronto), Toronto, ON, Canada.""}, {'ForeName': 'Brigida A', 'Initials': 'BA', 'LastName': 'Bruno', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Straus', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cantarutti', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, ON, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Bridgepoint Active Healthcare (Sinai Health System), Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frydrych', 'Affiliation': 'Mount Dennis Weston Health Centre, Humber River Family Health Team, Toronto, ON, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoang-Kim', 'Affiliation': ""St. Michael's Hospital (Unity Health Toronto), Toronto, ON, Canada.""}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Ivers', 'Affiliation': ""Department of Family and Community Medicine, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaplan', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Fok-Han', 'Initials': 'FH', 'LastName': 'Leung', 'Affiliation': ""St. Michael's Hospital (Unity Health Toronto), Toronto, ON, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Maxted', 'Affiliation': 'Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rezmovitz', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sale', 'Affiliation': ""Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital (Unity Health Toronto), Toronto, ON, Canada.""}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Sodhi-Helou', 'Affiliation': 'Toronto Western Family Health Team, Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'School of Nursing, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Telner', 'Affiliation': 'South East Toronto Family Health Team (Toronto East Health Network), Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/16984']
3006,32997300,Training general practitioners to improve evidence-based drug treatment of patients with heart failure: a cluster randomised controlled trial.,"AIMS


To assess whether a single training session for general practitioners (GPs) improves the evidence-based drug treatment of heart failure (HF) patients, especially of those with HF with reduced ejection fraction (HFrEF).
METHODS AND RESULTS


A cluster randomised controlled trial was performed for which patients with established HF were eligible. Primary care practices (PCPs) were randomised to care-as-usual or to the intervention group in which GPs received a half-day training session on HF management. Changes in HF medication, health status, hospitalisation and survival were compared between the two groups. Fifteen PCPs with 200 HF patients were randomised to the intervention group and 15 PCPs with 198 HF patients to the control group. Mean age was 76.9 (SD 10.8) years; 52.5% were female. On average, the patients had been diagnosed with HF 3.0 (SD 3.0) years previously. In total, 204 had HFrEF and 194 HF with preserved ejection fraction (HFpEF). In participants with HFrEF, the use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers decreased in 6 months in both groups [5.2%; (95% confidence interval (CI) 2.0-10.0)] and 5.6% (95% CI 2.8-13.4)], respectively [baseline-corrected odds ratio (OR) 1.07 (95% CI 0.55-2.08)], while beta-blocker use increased in both groups by 5.2% (95% CI 2.0-10.0) and 1.1% (95% CI 0.2-6.3), respectively [baseline-corrected OR 0.82 (95% CI 0.42-1.61)]. For health status, hospitalisations or survival after 12-28 months there were no significant differences between the two groups, also not when separately analysed for HFrEF and HFpEF.
CONCLUSION


A half-day training session for GPs does not improve drug treatment of HF in patients with established HF.",2020,"For health status, hospitalisations or survival after 12-28 months there were no significant differences between the two groups, also not when separately analysed for HFrEF and HFpEF.
CONCLUSION


","['patients with heart failure', 'Mean age was 76.9 (SD 10.8) years; 52.5% were female', 'patients had been diagnosed with HF 3.0 (SD 3.0) years previously', 'Fifteen PCPs with 200 HF patients', 'In total, 204 had HFrEF and 194 HF with preserved ejection fraction (HFpEF', 'patients with established HF were eligible', 'patients with established HF', 'heart failure (HF) patients, especially of those with HF with reduced ejection fraction (HFrEF', 'general practitioners (GPs']","['care-as-usual or to the intervention group in which GPs received a\xa0half-day training session on HF management', 'angiotensin-converting enzyme inhibitors/angiotensin receptor blockers']","['health status, hospitalisations or survival', 'HF medication, health status, hospitalisation and survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",200.0,0.256469,"For health status, hospitalisations or survival after 12-28 months there were no significant differences between the two groups, also not when separately analysed for HFrEF and HFpEF.
CONCLUSION


","[{'ForeName': 'M J M', 'Initials': 'MJM', 'LastName': 'Valk', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. M.J.M.Valk-7@umcutrecht.nl.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mosterd', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Landman', 'Affiliation': ', Leusden, The Netherlands.'}, {'ForeName': 'N P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'B D L', 'Initials': 'BDL', 'LastName': 'Broekhuizen', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01487-x']
3007,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE


The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS


A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS


The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION


The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
3008,32994235,Evaluating an implementation programme for medication review with follow-up in community pharmacy using a hybrid effectiveness study design: translating evidence into practice.,"OBJECTIVES


To evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT).
SETTING


Community pharmacies in Spain.
PARTICIPANTS


135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over.
INTERVENTION


The intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT.
RESULTS


55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed.
CONCLUSIONS


The implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete.
TRIAL REGISTRATION NUMBER


CGFTRA-2017-01.",2020,"Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10.","['135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over', 'Community pharmacies in Spain']",[],"['number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life', 'MRF service outcomes', 'progress, reach, fidelity and integration', 'integration mean score', 'Fidelity average score']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0949128,"Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Varas-Doval', 'Affiliation': 'Department of Pharmaceutical Services, Spanish General Council of Official Colleges of Pharmacists, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Gastelurrutia', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain magastelu@farmanorte.org.'}, {'ForeName': 'Shalom I', 'Initials': 'SI', 'LastName': 'Benrimoj', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Zarzuelo', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Garcia-Cardenas', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Perez-Escamilla', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Martínez-Martínez', 'Affiliation': 'Clinical Pharmacy Section, Pharmacy Department, Universidad de Granada, Granada, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-036669']
3009,32994236,Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study).,"INTRODUCTION


Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a clinically suspected scaphoid fracture and normal initial radiographs is immobilisation with below-elbow cast for 2 weeks. However, most of these patients are treated unnecessarily because eventually less than 10% of them are diagnosed with an occult scaphoid fracture. To reduce overtreatment and costs as a result of unnecessary cast treatment in patients with a clinically suspected scaphoid fracture and normal initial radiographs, we designed a study to compare below-elbow cast treatment with supportive bandage treatment. We hypothesise that the functional outcome after 3 months is not inferior in patients treated with supportive bandage compared to patients treated with below-elbow cast, but with lower costs in the supportive bandage group.
METHODS AND ANALYSIS


The SUSPECT study is an open-labelled multicentre randomised controlled trial with non-inferiority design. A total of 180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs are randomised between two groups: 3 days of supportive bandage or 2 weeks of below-elbow cast. We aim to evaluate the functional outcome and cost-effectiveness of both treatments. The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score. Secondary outcomes include functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity.
ETHICS AND DISSEMINATION


The Medical Ethics Committee of the Erasmus MC Medical Centre, Rotterdam, approved the study protocol (MEC-2017-504). We plan to present the results after completion of the study at (inter)national conferences and publish in general peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NL6976.",2020,"The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score.","['patients with a clinically suspected scaphoid fracture and normal initial radiographs', '180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs']","['supportive bandage', 'supportive bandage or 2 weeks of below-elbow cast', 'supportive bandage or CasT? ']","['functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score', 'functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity', 'functional outcome and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0438837', 'cui_str': 'Below elbow cast'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",180.0,0.122788,"The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score.","[{'ForeName': 'Abigael', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands a.cohen.1@erasmusmc.nl.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Kraan', 'Affiliation': 'Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Nina M C', 'Initials': 'NMC', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Koopmanschap', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Jan A N', 'Initials': 'JAN', 'LastName': 'Verhaar', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Mol', 'Affiliation': 'Department of Emergency Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'Colaris', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-036998']
3010,32994371,Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design.,"BACKGROUNDS


Embolic stroke is one of the main mechanisms of ischaemic stroke. Even if treated with recommended antithrombotic agents, stroke recurrence remains high. The Shuxuetong injection, a purified extract of traditional Chinese medicine widely used for thrombus diseases in clinical practice in China, could be a promising agent to prevent stroke recurrence.
AIMS


To describe the design of the Shuxuetong injection for prevention of recurrence in acute ischaemic stroke with embolism mechanisms.
DESIGN


The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days. An estimated 2416 patients with embolic stroke within 72 hours of symptom onset from 80 hospitals will be randomly assigned to one of two groups receiving Shuxuetong injection or placebo injection for 10 days. The primary endpoint is symptomatic or asymptomatic new cerebral infarction within 10 days after randomisation.
CONCLUSION


The SPACE Trial will provide valuable evidence for the efficacy and safety of Shuxuetong injection for the prevention of stroke recurrence in patients with imaging-defined embolic stroke.
CLINICAL TRIAL REGISTRATION


NCT03090113.",2020,"The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days.","['acute ischaemic stroke with embolism mechanisms', '2416 patients with embolic stroke within 72\u2009hours of symptom onset from 80 hospitals', 'patients with imaging-defined embolic stroke', 'patients with acute embolic stroke within 10 days']","['placebo', 'Shuxuetong injection', 'Shuxuetong injection or placebo injection']","['efficacy and safety', 'symptomatic or asymptomatic new cerebral infarction']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2606430', 'cui_str': 'shuxuetong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}]",2416.0,0.57285,"The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days.","[{'ForeName': 'Hong-Qiu', 'Initials': 'HQ', 'LastName': 'Gu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xue-Wei', 'Initials': 'XW', 'LastName': 'Xie', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Dong', 'Initials': 'JD', 'LastName': 'Yu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang-Ping', 'Initials': 'XP', 'LastName': 'Lv', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2019-000293']
3011,33001334,A Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and Medication Adherence in Patients with Diabetes.,"BACKGROUND


Mail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence.
OBJECTIVE


To assess an intervention to encourage MOP services to increase its use and medication adherence.
DESIGN


Randomized encouragement trial.
PATIENTS


63,012 diabetes patients from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Hawaii (KPHI), and Harvard Pilgrim Health Care (HPHC) who were poorly adherent to at least one class of cardiometabolic medications and had not used MOP in the prior 12 months.
INTERVENTION


Patients were randomized to receive either usual care (control arm) or outreach encouraging MOP use consisting of a mailed letter, secure email message, and automated telephone call outlining the potential benefits of MOP use (intervention arm). HPHC intervention patients received the letter only.
MEASUREMENTS


We compared the percentages of patients that began using MOP and that became adherent to cardiometabolic medication classes during a 12-month follow-up period. We also conducted a race/ethnicity-stratified analysis.
RESULTS


During follow-up, 10.6% of intervention patients began using MOP vs. 9.3% of controls (p < 0.01); the percent of cardiometabolic medication delivered via mail was 42.1% vs. 39.8% (p < 0.01). Metformin adherence improved in the intervention arm relative to control at the two KP sites (52% vs. 49%, p < 0.01). Stratified analyses suggested a significant positive effect of the intervention in White (RR: 1.12, 95% CI: 1.03, 1.22) and Asian (RR: 1.30, 95% CI: 1.17, 1.45) patients.
CONCLUSION


This pragmatic trial showed that simple outreach to encourage MOP modestly increased its use and improved adherence measured by refills to a key class of diabetes medications in some settings. Given its minimal cost, clinicians and health systems should consider outreach interventions to actively promote MOP use among diabetes patients.
TRIAL REGISTRATION


ClinicalTrials.gov registration number: NCT02621476.",2020,"Metformin adherence improved in the intervention arm relative to control at the two KP sites (52% vs. 49%, p < 0.01).","['Patients with Diabetes', 'diabetes patients', 'patients with diabetes', '63,012 diabetes patients from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Hawaii (KPHI), and Harvard Pilgrim Health Care (HPHC) who were poorly adherent to at least one class of cardiometabolic medications and had not used MOP in the prior 12\xa0months']","['HPHC intervention', 'usual care (control arm) or outreach encouraging MOP use consisting of a mailed letter, secure email message, and automated telephone call outlining the potential benefits of MOP use (intervention arm']","['Metformin adherence', 'cardiometabolic medication delivered via mail']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0024494', 'cui_str': 'Mail-Order'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024494', 'cui_str': 'Mail-Order'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]",,0.0558456,"Metformin adherence improved in the intervention arm relative to control at the two KP sites (52% vs. 49%, p < 0.01).","[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Ramachandran', 'Affiliation': 'Cohere Health, Boston, MA, USA.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Trinacty', 'Affiliation': 'University of Hawaii at Manoa, Honolulu, HI, USA.'}, {'ForeName': 'J Frank', 'Initials': 'JF', 'LastName': 'Wharam', 'Affiliation': 'Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy T', 'Initials': 'WT', 'LastName': 'Dyer', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA.'}, {'ForeName': 'Romain S', 'Initials': 'RS', 'LastName': 'Neugebauer', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Karter', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA.'}, {'ForeName': 'Cassondra J', 'Initials': 'CJ', 'LastName': 'Marshall', 'Affiliation': 'University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ross-Degnan', 'Affiliation': 'Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, 94612, USA. Julie.A.Schmittdiel@kp.org.'}]",Journal of general internal medicine,['10.1007/s11606-020-06237-8']
3012,32998221,Evaluation of Root-End Preparation with Two Different Endodontic Microsurgery Ultrasonic Tips.,"The aim of this study is to compare root-end preparation performed with two different ultrasonic tips-CVDentus and NSK-and respective time requirements. After root-end resection, 32 teeth were randomly divided in two groups, according to the ultrasonic tip used for root-end preparation. Preparation time was recorded. Photomicrographs were taken to assess the following parameters: root surface microcracking, marginal integrity and presence of debris. One ultrasonic tip from each group was analyzed through scanning electron microscopy before and after root-end preparation. The significance level was set at α = 0.05. Incidence of microcracks in both groups was 12.5%. Solely intracanal microcracking was found, consistently positioned within the widest side of the remaining dentine. No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p  = 0.102) and preparation time ( p  = 0.780), whereas statistical differences ( p  = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group). NSK tips showed major morphological changes, with extensive surface wear and noticeable loss of particles, which was not verified on CVDentus tips. Our findings suggest significant differences regarding root-end preparation walls quality, with CVDentus tips showing better results. Concerning microcracking, as well as preparation time and marginal integrity, both ultrasonic tips showed similar results. Qualitative analysis exposed NSK tips major morphological changes and wear after use, which was not verified on CVDentus tips.",2020,"No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p  = 0.102) and preparation time ( p  = 0.780), whereas statistical differences ( p  = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group).",[],['ultrasonic tips-CVDentus and NSK-and respective time requirements'],"['preparation time', 'Incidence of microcracks', 'marginal integrity']",[],"[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",32.0,0.0170176,"No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p  = 0.102) and preparation time ( p  = 0.780), whereas statistical differences ( p  = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group).","[{'ForeName': 'Paulo J', 'Initials': 'PJ', 'LastName': 'Palma', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Joana A', 'Initials': 'JA', 'LastName': 'Marques', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Casau', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Caramelo', 'Affiliation': 'Coimbra Institute for Clinical and Biomedical Research (iCBR), Laboratory of Biostatistics and Medical Informatics (LBIM), Faculty of Medicine, University of Coimbra, 3000-548 Coimbra, Portugal.'}, {'ForeName': 'Rui I', 'Initials': 'RI', 'LastName': 'Falacho', 'Affiliation': 'Institute of Oral Implantology and Prosthodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'João Miguel', 'Initials': 'JM', 'LastName': 'Santos', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}]",Biomedicines,['10.3390/biomedicines8100383']
3013,32998321,Feasibility of a 12 Week Physical Intervention to Prevent Cognitive Decline and Disability in the At-Risk Elderly Population in Korea.,"There is a need for measures that can prevent the onset of dementia in the rapidly aging population. Reportedly, sustained physical exercise can prevent cognitive decline and disability. This study aimed to assess the feasibility of a 12-week physical exercise intervention (PEI) for delay of cognitive decline and disability in the at-risk elderly population in Korea. Twenty-six participants (aged 67.9 ± 3.6 years, 84.6% female) at risk of dementia were assigned to facility-based PEI ( n  = 15) or home-based PEI ( n  = 11). The PEI program consisted of muscle strength training, aerobic exercise, balance, and stretching using portable aids. Feasibility was assessed by retention and adherence rates. Physical fitness/cognitive function were compared before and after the PEI. Retention and adherence rates were 86.7% and 88.3%, respectively, for facility-based PEI and 81.8% and 62.3% for home-based PEI. No intervention-related adverse events were reported. Leg strength/endurance and cardiopulmonary endurance were improved in both groups: 30 s sit-to-stand test (facility-based,  p  = 0.002; home-based,  p  = 0.002) and 2 -min stationary march (facility-based,  p  = 0.001; home-based,  p  = 0.022). Cognitive function was improved only after facility-based PEI (Alzheimer's Disease Assessment Scale-cognitive total score,  p  = 0.009; story memory test on Literacy Independent Cognitive Assessment,  p  = 0.026). We found that, whereas our PEI is feasible, the home-based program needs supplementation to improve adherence.",2020,Leg strength/endurance and cardiopulmonary endurance were improved in both groups:,"['in the At-Risk Elderly Population in Korea', 'at-risk elderly population in Korea', 'Twenty-six participants (aged 67.9 ± 3.6 years, 84.6% female) at risk of dementia were assigned to facility-based PEI ( n  = 15) or home-based PEI ( n  = 11']","['muscle strength training, aerobic exercise, balance, and stretching using portable aids', 'physical exercise intervention (PEI', '12 Week Physical Intervention', 'sustained physical exercise']","['cognitive decline and disability', 'Physical fitness/cognitive function', 'Leg strength/endurance and cardiopulmonary endurance', 'Retention and adherence rates', 'adverse events', 'Cognitive function', ""facility-based PEI (Alzheimer's Disease Assessment Scale-cognitive total score"", 'retention and adherence rates', 'Cognitive Decline and Disability']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3697373', 'cui_str': 'At risk of dementia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0216671,Leg strength/endurance and cardiopulmonary endurance were improved in both groups:,"[{'ForeName': 'Sun Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Hong-Sun', 'Initials': 'HS', 'LastName': 'Song', 'Affiliation': 'Department of Sports Science, Korea Institute of Sport Science, Seoul 01794, Korea.'}, {'ForeName': 'Buong-O', 'Initials': 'BO', 'LastName': 'Chun', 'Affiliation': 'Department of Sports Science, Korea Institute of Sport Science, Seoul 01794, Korea.'}, {'ForeName': 'Muncheong', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'Exercowork, Hanam 12912, Korea.'}, {'ForeName': 'Kyunghwa', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Ki Sub', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Dongtan Public Health Center, Hwaseong 18460, Korea.'}, {'ForeName': 'Hyesu', 'Initials': 'H', 'LastName': 'Jeon', 'Affiliation': 'Department of Psychology, Ajou University, Suwon 16499, Korea.'}, {'ForeName': 'Da Eun', 'Initials': 'DE', 'LastName': 'Seo', 'Affiliation': 'Department of Psychology, Ajou University, Suwon 16499, Korea.'}, {'ForeName': 'Hye Mi', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jee Hyang', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Ewha Womans University School of medicine, Seoul 07804, Korea.'}, {'ForeName': 'Yoo Kyoung', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Medical Nutrition, Graduate School of East-West Medical Nutrition, Kyung Hee University, Suwon 17104, Korea.'}, {'ForeName': 'Chang Hyung', 'Initials': 'CH', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Hae Ri', 'Initials': 'HR', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Bobath Memorial Hospital, Seongnam 13552, Korea.'}, {'ForeName': 'Seong Hye', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Neurology, Inha University College of Medicine, Incheon 22212, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Moon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103135']
3014,32998324,Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial.,"Improvements in macular pigment optical density (MPOD) and contrast sensitivity after administration of 12 mg lutein alone and the timing at which efficacy is observed remain unknown. Therefore, lutein (12 mg), a crystalline formulation, was used in this study, considering its bioaccessibility. This study aimed to determine the effects of lutein administration for 16 weeks on MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels were determined. The study subjects comprised 59 healthy male and female adults aged 20-69 years. The study diet included a placebo (placebo group) or a diet supplemented with 12 mg of lutein (lutein group). Each study diet was continuously administered for 16 weeks. At weeks 8 and 16, MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels were evaluated. Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16. Continuous administration of lutein for 16 weeks, considering its bioaccessibility, increased MPOD; it made the outlines of visible objects clearer and was effective in inhibiting decreases in visual function caused by glare from light.",2020,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.",['59 healthy male and female adults aged 20-69 years'],"['Dietary Supplementation of Lutein with High Bio-Accessibility', 'placebo (placebo', 'lutein', 'diet supplemented with 12 mg of lutein (lutein group', 'placebo', 'Placebo']","['Macular Pigment Optical Density and Contrast Sensitivity', 'MPOD', 'MPOD, contrast sensitivity, and glare sensitivity', 'MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels', 'visual function', 'serum lutein levels', 'macular pigment optical density (MPOD) and contrast sensitivity', 'MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",59.0,0.172558,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.","[{'ForeName': 'Naomichi', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Omnica Co., Ltd. TN Koshikawa Building 5th floor 4--21-7 Itabashi, Itabashiku, Tokyo 173-0004, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kosehira', 'Affiliation': 'Graduate School of Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado-city, Saitama 350-0295, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Kitaichi', 'Affiliation': 'Department of Ophthalmology, Health Sciences University of Hokkaido, 1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido 061-0293, Japan.'}]",Nutrients,['10.3390/nu12102966']
3015,32998401,The Feasibility and Preliminary Efficacy of an eHealth Lifestyle Program in Women with Recent Gestational Diabetes Mellitus: A Pilot Study.,"Self-administered eHealth interventions provide a potential low-cost solution for reducing diabetes risk. The aim of this pilot randomised controlled trial (RCT) was to evaluate the feasibility, including recruitment, retention, preliminary efficacy (primary outcome) and acceptability (secondary outcome) of the ""Body Balance Beyond"" eHealth intervention in women with previous gestational diabetes mellitus (GDM). Women with overweight/obesity who had recent GDM (previous 24 months) were randomised into one of three groups: 1) high personalisation (access to ""Body Balance Beyond"" website, individual telehealth coaching via video call by a dietitian and exercise physiologist, and text message support); 2) low personalisation (website only); or 3) waitlist control. To evaluate preliminary efficacy, weight (kg), glycosylated hemoglobin, type A1C (HbA1c), cholesterol (total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL)), diet quality and moderate-vigorous physical activity were analysed at baseline and at 3 and 6 months using generalised linear mixed models. To investigate acceptability, process evaluation was conducted at 3 and 6 months. Of the 327 potential participants screened, 42 women (mean age 33.5 ± 4.0 years and BMI 32.4 ± 4.3 kg/m 2 ) were randomised, with 30 (71%) completing the study. Retention at 6 months was 80%, 54% and 79% for high personalisation, low personalisation and waitlist control, respectively (reasons: personal/work commitments,  n  = 4; started weight-loss diet,  n  = 1; pregnant,  n  = 1; resources not useful,  n  = 1; and not contactable,  n  = 5). No significant group-by-time interactions were observed for preliminary efficacy outcomes, with the exception of HDL cholesterol, where a difference favoured the low personalisation group relative to the control ( p  = 0.028). The majority (91%) of women accessed the website in the first 3 months and 57% from 4-6 months. The website provided useful information for 95% and 92% of women at 3 and 6 months, respectively, although only a third of women found it motivating (30% and 25% at 3 and 6 months, respectively). Most women agreed that the telehealth coaching increased their confidence for improving diet (85%) and physical activity (92%) behaviours, although fewer women regarded the text messages as positive (22% and 31% for improving diet and physical activity, respectively). The majority of women (82% at 3 months and 87% at 6 months) in the high personalisation group would recommend the program to other women with GDM. Recruiting and retaining women with a recent diagnosis of GDM is challenging. The ""Body Balance Beyond"" website combined with telehealth coaching via video call is largely acceptable and useful for women with recent GDM. Further analysis of the effect on diabetes risk reduction in a larger study is needed.",2020,"Retention at 6 months was 80%, 54% and 79% for high personalisation, low personalisation and waitlist control, respectively (reasons: personal/work commitments,  n  = 4; started weight-loss diet,  n  = 1; pregnant,  n  = 1; resources not useful,  n  = 1; and not contactable,  n  = 5).","['Women with overweight/obesity who had recent GDM (previous 24 months', 'women with recent GDM', '327 potential participants screened, 42 women (mean age 33.5 ± 4.0 years and BMI 32.4 ± 4.3 kg/m 2 ', 'Women with Recent Gestational Diabetes Mellitus', 'women with previous gestational diabetes mellitus (GDM']","['eHealth Lifestyle Program', 'high personalisation (access to ""Body Balance Beyond"" website, individual telehealth coaching via video call by a dietitian and exercise physiologist, and text message support); 2) low personalisation (website only); or 3) waitlist control', 'Body Balance Beyond"" eHealth intervention', 'telehealth coaching']","['diabetes risk reduction', 'efficacy, weight (kg), glycosylated hemoglobin, type A1C (HbA1c), cholesterol (total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL)), diet quality and moderate-vigorous physical activity', 'HDL cholesterol', 'physical activity', 'diabetes risk']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517759', 'cui_str': '4.3'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",42.0,0.0552827,"Retention at 6 months was 80%, 54% and 79% for high personalisation, low personalisation and waitlist control, respectively (reasons: personal/work commitments,  n  = 4; started weight-loss diet,  n  = 1; pregnant,  n  = 1; resources not useful,  n  = 1; and not contactable,  n  = 5).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Baldwin', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hutchesson', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Elroy J', 'Initials': 'EJ', 'LastName': 'Aguiar', 'Affiliation': 'Department of Kinesiology, College of Education, The University of Alabama, Tuscaloosa, AL 35487, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wynne', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': 'Clinical Services, Nursing and Midwifery, Hunter New England Local Health District, Wallsend, NSW 2287, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Haslam', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17197115']
3016,33019274,Can not touching the nose or eyes help cold prevention? Possibility of application using a smartwatch and self-checking.,"More than 200 virus strains have been implicated in common colds, thereby thwarting vaccination efforts. However, the most common causes of colds are human rhinoviruses, which infect the epithelial cells of the nasopharynx. Moreover, after decades of research, the best documented method of preventing infection remains to be handwashing. However, stopping people from inadvertently touching or rubbing one's nose and eyes is difficult, and the effectiveness of preventing such habits has not been validated. Here, we reported the results of a randomized controlled trial (n = 120) performed over 50 days. We examined the effectiveness of using smartwatches equipped with a sensor and a vibration alert, as well as the self-checking of behavior, in preventing subjects from touching their nose or eyes. Participants were randomly assigned to either the smartwatch group or the handwashing group (control). Subjects in the handwashing group were requested to wash their hands after going out, whereas subjects in the smartwatch group were requested to wash their hands and in addition wear a smartwatch that vibrates to remind them not to excessively touch their nose or eyes. The daily frequency of nose and eye touching was also recorded by the smartwatches. The first incidence of an upper respiratory tract infection (URTI) was the primary endpoint. In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).",2020,"In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).",[],"['smartwatch group or the handwashing group (control', 'smartwatch group were requested to wash their hands and in addition wear a smartwatch that vibrates to remind them not to excessively touch their nose or eyes']","['incidence of URTIs', 'upper respiratory tract infection (URTI', 'mean frequency of nose or eye touching', 'daily frequency of nose and eye touching']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.026638,"In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).","[{'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176589']
3017,33019332,Comparison of Three Normalization Methods in Monitoring Analgesic Depth with Photoplethysmographic Diastolic Interval.,"The purpose of the present study was to investigate the ability of three different normalization methods, namely root mean square (RMS) value, mean value, and maximum which referred to pulse beat interval (PBI), based on photoplethysmographic diastolic interval (DI) in response to laryngeal mask airway (LMA) insertion under various remifentanil concentrations during general anesthesia. Sixty patients were randomly allocated to one of the four groups to receive a possible remifentanil effect-compartment target concentration (Ce remi ) of 0, 1, 3, or 5 ng/ml, and an effect-compartment target controlled infusion of propofol to maintain the state entropy (SE) at 40~60. Three normalized measures DI RMS , DI Mean , and DIPBI were compared with the DI values without normalization. Before LMA insertion, only DI showed a considerable correlation with remifentanil concentrations. DI RMS  and DI Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml). DIRMS was superior to all other variables in grading analgesic depth after nociceptive event occurred with PK value of 0.836. These results demonstrate that the normalization using RMS value, compared to using mean value and maximum, seems to provide a more effective approach for signal pre-processing.",2020,Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml).,"['Sixty patients', 'general anesthesia']","['remifentanil effect-compartment target concentration (Ce remi ) of 0, 1, 3, or 5 ng/ml, and an effect-compartment target controlled infusion of propofol to maintain the state entropy (SE', 'laryngeal mask airway (LMA) insertion']","['namely root mean square (RMS) value, mean value, and maximum which referred to pulse beat interval (PBI), based on photoplethysmographic diastolic interval (DI', 'DI RMS  and DI', 'normalized measures DI RMS , DI Mean , and DIPBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",60.0,0.0348147,Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml).,"[{'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ''}, {'ForeName': 'Shali', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175443']
3018,33020951,"Comparison of commercially available 0.2% chlorhexidine mouthwash with and without anti-discoloration system: A blinded, crossover clinical trial.","AIM


To evaluate clinical performance and side effects of two commercially available 0.2% chlorhexidine mouthwashes after periodontal surgery, one with (test) and one without (control) an anti-discoloration system.
MATERIALS AND METHODS


This single-centre, crossover clinical trial included 38 patients undergoing two sessions of periodontal flap surgery. The participants used two different 0.2% chlorhexidine products, one with and one without an anti-discoloration system, in the 14-day post-operative periods. Plaque, gingival inflammation, tooth staining, side effects and patient preference were evaluated.
RESULTS


The control mouthwash (without an anti-discolouring system) produced significantly lower plaque (p = 0.02) and gingival index (p = 0.01) compared to the test mouthwash. The test mouthwash produced significantly less staining in the gingival (p = 0.002) and approximal areas (p = 0.0004), but no difference was detected in the buccal area of the teeth. The patients did not show preference for any of the mouthwashes.
CONCLUSION


Chlorhexidine mouthwash without an anti-discoloration system resulted in significantly lowered plaque and gingival index compared to chlorhexidine mouthwash with an anti-discoloration following periodontal surgery. No difference in patient preference was found despite less side effects produced by the chlorhexidine mouthwash with the anti-discoloration system.",2020,"The test mouthwash produced significantly less staining in the gingival (p=0.002) and approximal areas (p=0.0004), but no difference was detected in the buccal area of the teeth.",['38 patients undergoing two sessions of periodontal flap surgery'],"['chlorhexidine mouthwashes', 'chlorhexidine', 'chlorhexidine mouthwash with and without Anti-Discoloration System', 'Chlorhexidine']","['plaque - (p=0.02) and gingival index', 'Plaque, gingival inflammation, tooth staining, side-effects and patient preference', 'plaque- and gingival index', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",38.0,0.0699635,"The test mouthwash produced significantly less staining in the gingival (p=0.002) and approximal areas (p=0.0004), but no difference was detected in the buccal area of the teeth.","[{'ForeName': 'Erik Klepsland', 'Initials': 'EK', 'LastName': 'Mauland', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hans R', 'Initials': 'HR', 'LastName': 'Preus', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne Merete', 'Initials': 'AM', 'LastName': 'Aass', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}]",Journal of clinical periodontology,['10.1111/jcpe.13382']
3019,33021481,Effectiveness of a Participatory and Interactive Virtual Reality Intervention in Patients With Social Anxiety Disorder: Longitudinal Questionnaire Study.,"BACKGROUND


Social anxiety disorder (SAD) is characterized by excessive fear of negative evaluation and humiliation in social interactions and situations. Virtual reality (VR) treatment is a promising intervention option for SAD.
OBJECTIVE


The purpose of this study was to create a participatory and interactive VR intervention for SAD. Treatment progress, including the severity of symptoms and the cognitive and emotional aspects of SAD, was analyzed to evaluate the effectiveness of the intervention.
METHODS


In total, 32 individuals with SAD and 34 healthy control participants were enrolled in the study through advertisements for online bulletin boards at universities. A VR intervention was designed consisting of three stages (introduction, core, and finishing) and three difficulty levels (easy, medium, and hard) that could be selected by the participants. The core stage was the exposure intervention in which participants engaged in social situations. The effectiveness of treatment was assessed through Beck Anxiety inventory (BAI), State-Trait Anxiety Inventory (STAI), Internalized Shame Scale (ISS), Post-Event Rumination Scale (PERS), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Brief-Fear of Negative Evaluation Scale (BFNE), and Liebowitz Social Anxiety Scale (LSAS).
RESULTS


In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process. Compared with the healthy control group before treatment, the SAD group showed significantly higher scores on all scales (P<.001), and these significant differences persisted even after treatment (P<.001). In the comparison between the VR treatment responder and nonresponder subgroups, there was no significant difference across the course of the VR session.
CONCLUSIONS


These findings indicated that a participatory and interactive VR intervention had a significant effect on alleviation of the clinical symptoms of SAD, confirming the usefulness of VR for the treatment of SAD. VR treatment is expected to be one of various beneficial therapeutic approaches in the future.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS) KCT0003854; https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=13508.",2020,"In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process.","['Patients With Social Anxiety Disorder', '32 individuals with SAD and 34 healthy control participants were enrolled in the study through advertisements for online bulletin boards at universities', 'Social anxiety disorder (SAD']","['Virtual reality (VR) treatment', 'participatory and interactive VR intervention', 'Participatory and Interactive Virtual Reality Intervention']","['SPS', 'ISS', 'BAI', 'STAI-Trait', 'BFNE', 'Beck Anxiety inventory (BAI), State-Trait Anxiety Inventory (STAI), Internalized Shame Scale (ISS), Post-Event Rumination Scale (PERS), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Brief-Fear of Negative Evaluation Scale (BFNE), and Liebowitz Social Anxiety Scale (LSAS', 'severity of symptoms and the cognitive and emotional aspects of SAD', 'LSAS', 'alleviation of the clinical symptoms of SAD', 'KSAD', 'PERS-negative']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0243152', 'cui_str': 'emotional aspects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",32.0,0.0147694,"In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process.","[{'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chungnam National University Sejong Hospital, Sejong, Republic of Korea.'}, {'ForeName': 'Dooyoung', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': 'Department of Human Factors Engineering, Ulsan National Institute of Science and Technology, Ulsan, Republic of Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Heon-Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Sungkil', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Software, Sungkyunkwan University, Suwon, Republic of Korea.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Kim', 'Affiliation': 'Digital Experience Laboratory, Department of Computer Science and Engineering, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Chung-Yean', 'Initials': 'CY', 'LastName': 'Cho', 'Affiliation': 'Department of Film & Multimedia, Korea National University of Arts, Seoul, Republic of Korea.'}, {'ForeName': 'Seungmoon', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Computer Science and Engineering, Pohang University of Science and Technology, Pohang, Republic of Korea.'}, {'ForeName': 'Seung-Moo', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Film & Multimedia, Korea National University of Arts, Seoul, Republic of Korea.'}, {'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/23024']
3020,33026160,A phase 3 randomized clinical trial using a once-weekly glucagon-like peptide-1 receptor agonist in adolescents and young adults with hypothalamic obesity.,"AIM


To evaluate the efficacy, safety and tolerability of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with hypothalamic obesity (HO).
MATERIALS AND METHODS


A two-arm, randomized, multicentre, double-blind, placebo-controlled trial was conducted in 10- to 25-year-olds with hypothalamic injury following intracranial tumour and HO. Participants were randomized to once-weekly subcutaneous injections of a GLP-1 RA exenatide 2 mg (ExQW) or placebo for 36 weeks. The primary efficacy endpoint was 36-week % change in body mass index (BMI). Secondary outcomes included change in body composition (by dual energy x-ray absorptiometry).
RESULTS


Forty-two participants were randomized to ExQW (n = 23) or placebo (n = 19). Participants were 5 ± 2 years (mean ± SD) postdiagnosis and development of HO (BMI 37.3 ± 7.1 kg/m 2  ). In intention-to-treat analysis, the effect of 36-week ExQW vs. placebo on % Δ BMI was not significant (estimated treatment difference -1.7 ± 1.8%, 95% CI -4.1 to 0.6%, P = .40); however, total body fat mass was reduced (estimated treatment difference -3.1 ± 1.4 kg, 95% CI -5.7 to -0.4 kg, P = .02). There was a significant reduction in waist circumference (estimated effect of treatment -3.5 [95% CI -5.5 to -1.6] cm, P = .004). All patients treated with placebo increased % of adipose tissue, while 50% treated with ExQW had reductions (P < .001). Mean HbA1c, glucose tolerance and serum lipids did not change significantly with therapy. ExQW was well tolerated. The most frequent adverse events were transient gastrointestinal disturbances (ExQW vs. placebo: nausea 6/23 vs. 3/18, vomiting 4/23 vs. 4/18 and diarrhoea 7/23 vs. 3/18).
CONCLUSIONS


GLP-1 RAs are a promising and safe treatment to improve or stabilize HO in children and young adults.",2020,There was a significant reduction in waist circumference (estimated effect of treatment -3.5 (,"['Participants were 5±2\u2009years (mean±SD) post-diagnosis and development of HO (BMI 37.3±7.1 kg/m 2  ', 'children and young adults', 'Adolescents and Young Adults with Hypothalamic Obesity', '10-25-year-old people with hypothalamic injury following intracranial tumor and HO', 'Forty-two participants', 'patients with HO']","['ExQW vs. placebo', 'GLP-1 Receptor Agonist', 'GLP1RA', 'placebo', 'glucagon-like peptide-1 receptor agonist (GLP1RA', 'ExQW', 'GLP1RA exenatide 2mg (ExQW) or placebo']","['Δbody composition (by dual-energy x-ray absorptiometry', 'efficacy, safety, and tolerability', 'total body fat mass', 'waist circumference', 'tolerated', 'Mean HbA1c, glucose tolerance and serum lipids', 'percent adipose tissue']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0271885', 'cui_str': 'Hypothalamic obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442857', 'cui_str': 'Hypothalamic injury'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C4026820', 'cui_str': 'exenatide 2 MG'}]","[{'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",42.0,0.731804,There was a significant reduction in waist circumference (estimated effect of treatment -3.5 (,"[{'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Roth', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Perez', 'Affiliation': ""Department of Radiology, Seattle Children's and University of Washington, Seattle, Washington.""}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Whitlock', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Elfers', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Shoemaker', 'Affiliation': 'Division of Pediatric Endocrinology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'M Jennifer', 'Initials': 'MJ', 'LastName': 'Abuzzahab', 'Affiliation': ""McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Minnesota, St. Paul, Minnesota.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14224']
3021,33022911,"Free-Weight Resistance Exercise Is More Effective in Enhancing Inhibitory Control than Machine-Based Training: A Randomized, Controlled Trial.","Resistance exercise has been demonstrated to improve brain function. However, the optimal workout characteristics are a matter of debate. This randomized, controlled trial aimed to elucidate differences between free-weight (RE free ) and machine-based (RE mach ) training with regard to their ability to acutely enhance cognitive performance (CP). A total of  n  = 46 healthy individuals (27 ± 4 years, 26 men) performed a 45-min bout of RE free  (military press, barbell squat, bench press) or RE mach  (shoulder press, leg press, chest press). Pre- and post-intervention, CP was examined using the Stroop test, Trail Making Test and Digit Span test. Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05). However, RE free  was superior to RE mach  in the Stroop color-word condition (+6.3%,  p  = 0.02, R = 0.35). Additionally, RE free  elicited pre-post changes in all parameters except for the Digit Span test and the word condition of the Stroop test while RE mach  only improved cognitive performance in part A of the Trail Making test. Using free weights seems to be the more effective RE method to acutely improve cognitive function (i.e., inhibitory control). The mechanisms of this finding merit further investigation.",2020,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05).","['A total of  n  = 46 healthy individuals (27 ± 4 years, 26 men']","['free-weight (RE free ) and machine-based (RE mach ) training', '45-min bout of RE free  (military press, barbell squat, bench press) or RE mach  (shoulder press, leg press, chest press', 'Resistance exercise', 'Free-Weight Resistance Exercise', 'Pre- and post-intervention']","['cognitive performance', 'Stroop test, Trail Making Test and Digit Span test', 'Digit Span test, Trail Making test and the color and word conditions of the Stroop test', 'brain function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1144061', 'cui_str': 'CASP8 protein, human'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0454325', 'cui_str': 'Shoulder press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",46.0,0.0275825,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stricker', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Usedly', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100702']
3022,33022918,"Effects of Moderate Combined Resistance- and Aerobic-Exercise for 12 Weeks on Body Composition, Cardiometabolic Risk Factors, Blood Pressure, Arterial Stiffness, and Physical Functions, among Obese Older Men: A Pilot Study.","We demonstrated the hypothesis that combined exercise improves body composition, cardiometabolic risk factors, blood pressure (BP), arterial stiffness, and physical functions, in obese older men. Older men ( n  = 20) were randomly assigned to combined exercise training (EXP;  n  = 10) or control groups (CON;  n  = 10). The combined exercise was comprised of elastic-band resistance training and walking/running on a treadmill and bicycle at 60-70% of maximal heart rate for 3 days/weeks. EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05). The exercise program significantly reduced BP, mean arterial pressure, pulse pressure, and brachial-ankle pulse wave velocity. Furthermore, while the plasma levels of low-density lipoprotein cholesterol and epinephrine were significantly reduced in EXP, VO 2  peak and grip strength were significantly enhanced ( p  < 0.05). In conclusion, it is indicated that 12-week regular combined exercise improves body composition, cardiometabolic risk factors, hemodynamics, and physical performance in obese older men.",2020,"EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05).","['Older men ( n  = 20', 'Obese Older Men', 'obese older men']","['elastic-band resistance training and walking/running on a treadmill and bicycle', 'combined exercise', 'combined exercise training (EXP;  n  = 10) or control groups (CON', 'Moderate Combined Resistance- and Aerobic-Exercise']","['body composition, cardiometabolic risk factors, hemodynamics, and physical performance', 'Body Composition, Cardiometabolic Risk Factors, Blood Pressure, Arterial Stiffness, and Physical Functions', 'body composition, cardiometabolic risk factors, blood pressure (BP), arterial stiffness, and physical functions', 'plasma levels of low-density lipoprotein cholesterol and epinephrine', 'BP, mean arterial pressure, pulse pressure, and brachial-ankle pulse wave velocity', 'body weight, body mass index, and %body fat', 'EXP, VO 2  peak and grip strength']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",20.0,0.0222169,"EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05).","[{'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Korea University, 145 Anam-ro, Seongbuk-gu, Seoul 02841, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kwangseok', 'Initials': 'K', 'LastName': 'Hong', 'Affiliation': 'Department of Physical Education, Chung-Ang University, 84 Heukseok-ro, Dongjak-gu, Seoul 06974, Korea.'}, {'ForeName': 'Yae-Young', 'Initials': 'YY', 'LastName': 'Kim', 'Affiliation': 'Department of Oriental Sports Medicine, Daegu Haany University, 1 Haanydaero, Gyeongsan-si, Gyeongsangbuk-Do 38610, Korea.'}, {'ForeName': 'Sung-Woo', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197233']
3023,33023276,Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women.,"BACKGROUND


Maintaining adequate hydration is important for overall health and has major implications for athletes involved in physically demanding tasks. While water is viewed as an effective means to rehydrate, and is inexpensive and readily available, electrolyte beverages appear to be more beneficial, in particular for athletes who routinely lose electrolytes through sweating. Nuun tablets contain a mix of electrolytes and are quickly dissolved in water to create an electrolyte-rich beverage. We determined the impact of Nuun tablets on the fluid balance of healthy, exercise-trained men and women at rest.
METHODS


Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs) ingested either water only or water with Nuun electrolyte tablets, at both a single and double strength concentration, in random order, on three separate occasions separated by approximately one week, in a fasted and euhydrated state. A total of 1 liter of fluid was ingested at each visit over a 30 minute period. Urine was collected from each subject at 0, 1, 2, 3, and 4 hours post-ingestion. Urine mass values were used to calculate fluid balance and the beverage hydration index (BHI; i.e., the volume of urine produced after drinking the Nuun beverages, relative to that of water only-control condition). Heart rate and blood pressure were measured throughout the four-hour period, while body weight was measured at the start and end of the experiment.
RESULTS


Neither heart rate nor blood pressure were impacted by beverage consumption. Nuun tablets resulted in a lower urine output compared to water, with fluid balances for both concentrations more favorable compared to water ( p  < 0.05), beginning at 2 h post-ingestion and continuing at the 3 h and 4 h times. Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg). The BHI was higher for Nuun (single dose in particular) compared to water at both 2 h ( p  = 0.05) and 4 h ( p  = 0.02).
CONCLUSION


The addition of Nuun electrolyte tablets to water improves the fluid balance and BHI in healthy men and women. Results were similar for both concentrations, suggesting that additional electrolytes are not necessary when in a rested state. Future studies should determine the impact of various concentrations of the Nuun beverage during physical exercise-in particular, exercise in the heat, when sweat loss may be highest.",2020,"Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg).","['healthy men and women', 'Active Men and Women', 'Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs', 'healthy, exercise-trained men and women at rest']","['Nuun tablets', 'Nuun Electrolyte Tablets', 'ingested either water only or water with Nuun electrolyte tablets']","['Body weight loss', 'heart rate nor blood pressure', 'BHI', 'Heart rate and blood pressure', 'body weight', 'fluid balance and BHI', 'lower urine output', 'Fluid Balance']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}]",,0.0942113,"Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg).","[{'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Pence', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12103030']
3024,33024120,Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study).,"Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], -1.04[-1.19, -0.89]%) and BBR-alone group (-0.99[-1.16, -0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (-0.59[-0.75, -0.44]%, -0.53[-0.68, -0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).",2020,BBR treatment induced more gastrointestinal side effects.,"['Four-hundred-nine eligible participants', 'newly diagnosed T2D patients from 20 centres in China']","['BBR-alone, probiotics+BBR, probiotics-alone, or placebo', 'berberine and probiotics', 'placebo', 'BBR']","['gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis', 'gastrointestinal side effects', 'glycated haemoglobin']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",409.0,0.295139,BBR treatment induced more gastrointestinal side effects.,"[{'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huahui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huanzi', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xuejiang', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated hospital of Wenzhou Medical University, Zhejiang Province, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangdong Province, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Tong Ren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Central Hospital of Minhang District, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Qilu Hospital of Shandong University, Shandong Province, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fujian Provincial Hospital, Fujian Province, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Shanghai Tenth People's Hospital of Tong Ji University, Shanghai, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Xuzhou Central Hospital, Jiangsu Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Chang Hai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Shanghai First People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guixue', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Zhun', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Huanming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guowang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Shenghan', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China. lijunhua@genomics.cn.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. wqingw61@163.com.'}]",Nature communications,['10.1038/s41467-020-18414-8']
3025,33025342,"Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects.","INTRODUCTION


The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE).
METHODS


In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods.
RESULTS


Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo.
CONCLUSION


Concomitant administration of ozanimod with PSE, a sympathomimetic agent, did not potentiate the effects on blood pressure.
TRIAL REGISTRATION


NCT03644576.",2020,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"['56 healthy adult subjects', 'Fifty-two subjects (92.9%) completed the study', 'healthy subjects', 'Healthy Subjects']","['PSE', 'Pseudoephedrine', 'placebo or ozanimod', 'PSE 60\xa0mg was co-administered with placebo or ozanimod', 'placebo', 'ozanimod', 'pseudoephedrine (PSE', 'ozanimod with PSE']","['blood pressure', 'circulating total active drug exposure', 'PK of PSE', 'Maximum time-matched change in systolic blood pressure (SBP', 'Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE', 'tolerated', 'Mean maximum time-matched change from baseline for SBP']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0989419', 'cui_str': 'Pseudoephedrine 60 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",56.0,0.322654,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Apex Biostatistics, Inc, New Hill, NC, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Sciences, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Nonclinical Research and Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Translational Medicine, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01500-0']
3026,33025835,Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial.,"This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional module in evidence-based parent training and whether the added module might detract from the efficacy of the original program. In a cluster randomized trial, six community-based organizations were randomized to deliver Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT as usual (PAT-AU). CSA-related awareness and protective behaviors, as well as general parenting behaviors taught by PAT were assessed at baseline, post-PAT, post-SPSHK, and 1-month follow-up. Multilevel analyses revealed significant group by time interactions for both awareness and behaviors ( ps <  .0001), indicating the PAT+SPSHK group had significantly greater awareness of CSA and used protective behaviors more often (which were maintained at follow-up) compared to the PAT-AU group. No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed. Results indicate adding SPHSK to existing parent training can significantly enhance parents' awareness of and readiness to engage in protective behavioral strategies. Implementing SPHSK as a selective prevention strategy with at-risk parents receiving parent training through child welfare infrastructures is discussed.",2020,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"['child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK']","['Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT', 'PAT+SPSHK']","['CSA-related awareness and protective behaviors', 'awareness of CSA and used protective behaviors']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",6.0,0.0313322,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Guastaferro', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Felt', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Font', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Connell', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sheridan', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Zadzora', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Jennie G', 'Initials': 'JG', 'LastName': 'Noll', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}]",Child maltreatment,['10.1177/1077559520963870']
3027,32960773,Applying Digital Information Delivery to Convert Habits of Antibiotic Use in Primary Care in Germany: Mixed-Methods Study.,"BACKGROUND


Antimicrobial resistance is an important global health issue. In Germany, the national agenda supports various interventions to convert habits of antibiotic use. In the CHANGE-3 (Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care) study, digital tools were applied for information delivery: tablet computers in primary care practices, e-learning platforms for medical professionals, and a public website to promote awareness and health literacy among primary care physicians, their teams, and their patients.
OBJECTIVE


This study is embedded in the process evaluation of the CHANGE-3 study. The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
METHODS


This study used a convergent-parallel mixed-methods design. Audio-recorded semistructured telephone interviews were conducted with physicians, nonphysician health professionals, and patients in the CHANGE-3 program. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was performed based on the inductive category of information provision via digital information tools. Identified themes were related to the main postulates of Diffusion of Innovations theory (DIT) to provide an explanatory frame. In addition, data generated through a structured survey with physicians and nonphysician health professionals in the program were analyzed descriptively and integrated with the qualitative data to explore the complementarity of the findings.
RESULTS


Findings regarding the acceptance and uptake of digital devices were related to three postulates of DIT: innovation characteristics, communication channels, and unanticipated consequences. Participants considered the provided digital educative solutions to be supportive for promoting health literacy regarding conversion of habits of antibiotic use. However, health care professionals found it challenging to integrate these solutions into existing routines in primary care and to align them with their professional values. Low technology affinity was a major barrier to the use of digital information in primary care. Patients welcomed the general idea of introducing health-related information in digital formats; however, they expressed concerns about device-related hygiene and the appropriateness of the digital tools for older patients.
CONCLUSIONS


Patients and medical professionals in German primary care are reluctant to use digital devices for information and education. Using a Diffusion of Innovations approach can support assessment of existing barriers and provide information about setting-specific preconditions that are necessary for future tailoring of implementation strategies.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 15061174; http://www.isrctn.com/ISRCTN15061174.",2020,"The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
","['primary care in Germany', 'Primary Care in Germany', 'older patients']",[],['acceptance and uptake of digital devices'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0477936,"The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Poss-Doering', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kuehn', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kamradt', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Glassen', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}]",Journal of medical Internet research,['10.2196/18200']
3028,31883218,"Associations between dietary patterns, eating behaviours, and body composition and adiposity in 3-year-old children of mothers with obesity.","BACKGROUND


The relationships between eating habits, behaviours, and the development of obesity in preschool children is not well established.
OBJECTIVE


As children of mothers with obesity are themselves at risk of obesity, we examined these relationships in a cohort of 482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT).
METHOD


Dietary patterns were derived using factor analysis of an 85-item food frequency questionnaire (FFQ). Eating behaviours were assessed using the Children's Eating Behaviour Questionnaire (CEBQ). Measures of body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage. Using adjusted regression analysis, we examined associations between dietary patterns, eating behaviours, and measures of body composition.
RESULTS


Three distinct dietary patterns were defined: ""healthy/prudent,"" ""African/Caribbean,"" and ""processed/snacking."" The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19). The ""African/Caribbean"" and the ""healthy/prudent"" patterns were associated with a lower arm circumference (β = -0.23 cm [-0.45 to -0.01]) and sum of skinfolds (β = -1.36 cm [-2.88 to -0.37]), respectively. Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety, were associated with lower arm and waist circumferences, WHO z scores, and obesity (all P < .05).
CONCLUSION


In children of mothers with obesity, those who had higher scores on a ""processed/snacking"" dietary pattern had greater odds of obesity. In contrast, slowness in eating was associated with lower measures of body composition. These novel findings highlight modifiable behaviours in high-risk preschool children which could contribute to public health strategies for prevention of childhood obesity.",2020,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","['482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT', 'preschool children', 'high-risk preschool children', '3-year-old children of mothers with obesity']",[],"['lower arm and waist circumferences, WHO z scores, and obesity', 'dietary patterns, eating behaviours, and body composition and adiposity', 'Eating behaviours', 'obesity', 'body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage', 'dietary patterns, eating behaviours, and measures of body composition', 'Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety', ""Children's Eating Behaviour Questionnaire (CEBQ""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0611576,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","[{'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",Pediatric obesity,['10.1111/ijpo.12608']
3029,31415033,mTOR Inhibitor Therapy Diminishes Circulating CD8+ CD28- Effector Memory T Cells and Improves Allograft Inflammation in Belatacept-refractory Renal Allograft Rejection.,"BACKGROUND


Renal allograft rejection is more frequent under belatacept-based, compared with tacrolimus-based, immunosuppression. We studied kidney transplant recipients experiencing rejection under belatacept-based early corticosteroid withdrawal following T-cell-depleting induction in a recent randomized trial (Belatacept-based Early Steroid Withdrawal Trial, clinicaltrials.gov NCT01729494) to determine mechanisms of rejection and treatment.
METHODS


Peripheral mononuclear cells, serum creatinine levels, and renal biopsies were collected from 8 patients undergoing belatacept-refractory rejection (BRR). We used flow cytometry, histology, and immunofluorescence to characterize CD8 effector memory T cell (TEM) populations in the periphery and graft before and after mammalian target of rapamycin (mTOR) inhibition.
RESULTS


Here, we found that patients with BRR did not respond to standard antirejection therapy and had a substantial increase in alloreactive CD8 T cells with a CD28/DR/CD38/CD45RO TEM. These cells had increased activation of the mTOR pathway, as assessed by phosphorylated ribosomal protein S6 expression. Notably, everolimus (an mTOR inhibitor) treatment of patients with BRR halted the in vivo proliferation of TEM cells and their ex vivo alloreactivity and resulted in their significant reduction in the peripheral blood. The frequency of circulating FoxP3 regulatory T cells was not altered. Importantly, everolimus led to rapid resolution of rejection as confirmed by histology.
CONCLUSIONS


Thus, while prior work has shown that concomitant belatacept + mTOR inhibitor therapy is effective for maintenance immunosuppression, our preliminary data suggest that everolimus may provide an available means for effecting ""rescue"" therapy for rejections occurring under belatacept that are refractory to traditional antirejection therapy with corticosteroids and polyclonal antilymphocyte globulin.",2020,The frequency of circulating FoxP3 regulatory T cells was not altered.,"['patients with BRR', 'kidney transplant recipients experiencing rejection under belatacept-based early corticosteroid withdrawal following T-cell-depleting induction', '8 patients undergoing belatacept-refractory rejection (BRR']",['everolimus'],"['serum creatinine levels, and renal biopsies', 'frequency of circulating FoxP3 regulatory T cells', 'alloreactive CD8 T cells', 'Circulating CD8+ CD28- Effector Memory T Cells and Improves Allograft Inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0075747', 'cui_str': 'Lymphocyte antigen CD28'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",8.0,0.0223009,The frequency of circulating FoxP3 regulatory T cells was not altered.,"[{'ForeName': 'Cyd M', 'Initials': 'CM', 'LastName': 'Castro-Rojas', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Alzbeta', 'Initials': 'A', 'LastName': 'Godarova', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hummel', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Shields', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tremblay', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Alloway', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Jordan', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'E Steve', 'Initials': 'ES', 'LastName': 'Woodle', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hildeman', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}]",Transplantation,['10.1097/TP.0000000000002917']
3030,30657023,Negative rumours about a vaginal ring for HIV-1 prevention in sub-Saharan Africa.,"Rumours may influence health-related behaviours, including the uptake of and adherence to HIV prevention products. This study assessed the safety and effectiveness of a vaginal ring delivering the antiretroviral dapivirine for HIV prevention in Africa. We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe. In total 214 women participated in either single or serial in-depth interviews, or a focus group discussion. Three key findings emerged in the data. Firstly, rumours reflected fears concerning the ring and trial participation. Given the historical-political context of the countries in which the trial was conducted, the ring's investigational nature and its foreign origin, ring use was rumoured to cause negative health outcomes such as cancer and infertility and to be associated with practices such as witchcraft or Satanism. The salience of these rumours varied by country. Secondly, rumours reportedly affected participants' adherence to the ring, and other women's willingness to participate in the study. Finally, participants reported that participant engagement activities helped address rumours, resulting in enhanced trust and rapport between staff and participants.",2019,"We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe.","['In total 214 women participated in either single or serial in-depth interviews, or a focus group discussion', 'HIV prevention in Africa', 'study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe']",['vaginal ring delivering the antiretroviral dapivirine'],['safety and effectiveness'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]","[{'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",214.0,0.0457022,"We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe.","[{'ForeName': 'Miria', 'Initials': 'M', 'LastName': 'Chitukuta', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Unit (UZCHS-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Duby', 'Affiliation': 'Division of Social and Behavioural Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': ""Women's Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA.""}, {'ForeName': 'Teopista', 'Initials': 'T', 'LastName': 'Nakyanzi', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Tchangani', 'Initials': 'T', 'LastName': 'Tembo', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Petina', 'Initials': 'P', 'LastName': 'Musara', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Unit (UZCHS-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Unit (UZCHS-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Culture, health & sexuality",['10.1080/13691058.2018.1552989']
3031,32998416,"Nutritional Intervention Reduces Dyslipidemia, Fasting Glucose and Blood Pressure in People Living with HIV/AIDS in Antiretroviral Therapy: A Randomized Clinical Trial Comparing Two Nutritional Interventions.","Antiretroviral therapy (ART) increases the risk of cardiometabolic diseases in people living with HIV/AIDS (PLWHA). However, there is a lack of evidence regarding the effectiveness of a nutritional intervention on several cardiometabolic parameters in this population. Therefore, this study aimed to evaluate the effectiveness of two nutritional interventions on several cardiometabolic parameters in PLWHA treated with ART. A parallel randomized clinical trial was performed with PLWHA treated with ART. The participants ( n  = 88) were divided into two intervention groups: (1) nutritional counseling ( n  = 44) and (2) individualized dietary prescription ( n  = 44). The follow-up period was 30 weeks. A reduction in low-density lipoprotein (LDL) was the primary outcome. Secondary outcome variables were reductions in total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL). A multiple linear regression was used to analyze the effectiveness of the interventions, adjusted for sociodemographic, lifestyle, and clinical characteristics. Sixty-two PLWHA completed the trial (nutritional counseling,  n  = 32; individualized dietary prescription,  n  = 30). At follow-up, we observed in the nutritional counseling group significant reductions in SBP ( p  = 0.036) and DBP ( p  = 0.001). Significant reductions in FPG ( p  = 0.008) and DBP ( p  = 0.023) were found in the individualized dietary prescription group. In the fully adjusted models, significant reductions in LDL, SBP, DBP, and BMI were found in the individualized dietary prescription group. In conclusion, the two investigated nutritional interventions were effective in reducing some cardiometabolic risk factors in PLWHA. However, after adjustments for covariates, the individualized dietary prescription showed significant reductions in the primary outcome and, also, in more cardiometabolic risk factors than the nutritional counseling.",2020,Significant reductions in FPG ( p  = 0.008) and DBP ( p  = 0.023) were found in the individualized dietary prescription group.,"['people living with HIV/AIDS (PLWHA', 'participants ( n  = 88', 'People Living with HIV/AIDS in Antiretroviral Therapy']","['Nutritional Intervention', 'nutritional interventions', 'nutritional intervention', 'nutritional counseling ( n  = 44) and (2) individualized dietary prescription', 'PLWHA treated with ART', 'Antiretroviral therapy (ART']","['Dyslipidemia, Fasting Glucose and Blood Pressure', 'total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL', 'DBP', 'LDL, SBP, DBP, and BMI', 'low-density lipoprotein (LDL', 'cardiometabolic risk factors', 'several cardiometabolic parameters', 'FPG', 'SBP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0347523,Significant reductions in FPG ( p  = 0.008) and DBP ( p  = 0.023) were found in the individualized dietary prescription group.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Marianne Oliveira', 'Initials': 'MO', 'LastName': 'Falco', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Department of Public Health, Instituto Federal Goiano, Ceres 76300-000, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}]",Nutrients,['10.3390/nu12102970']
3032,32998471,Lactobacillus reuteri  DSM 17938 and Agave Inulin in Children with Cerebral Palsy and Chronic Constipation: A Double-Blind Randomized Placebo Controlled Clinical Trial.,"The main objective was to assess the efficacy of a probiotic ( Lactobacillus reuteri  DSM 17938), a prebiotic (agave inulin), and a synbiotic on the stool characteristics in children with cerebral palsy and chronic constipation. Thirty-seven children with cerebral palsy and chronic constipation were included. The probiotic group received 1 × 10 8  colony forming unit (cfu) of  L. reuteri  DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received  L. reuteri  DSM 17938 plus agave inulin, and the placebo group received two placebos for 28 days. The probiotic group showed a significant decrease in stool pH ( p  = 0.014). Stool consistency improved in the prebiotic group ( p  = 0.008). The probiotic, prebiotic, and synbiotic groups showed a significant improvement in the history of excessive stool retention, the presence of fecal mass in the rectum, and the history of painful defecation.  L. reuteri  concentration in feces was higher in the probiotic group than in the placebo group ( p  = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r  = -0.762,  p  = 0.028). This study showed that the use of  L. reuteri  DSM 17938 and/or agave inulin improved the stool characteristics such as the history of painful defecation and the presence of fecal mass in the rectum against placebo in children with cerebral palsy and chronic constipation.",2020,"L. reuteri  concentration in feces was higher in the probiotic group than in the placebo group ( p  = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r  = -0.762,  p  = 0.028).","['Children with Cerebral Palsy and Chronic Constipation', 'children with cerebral palsy and chronic constipation', 'Thirty-seven children with cerebral palsy and chronic constipation were included']","['probiotic ( Lactobacillus reuteri  DSM 17938), a prebiotic (agave inulin), and a synbiotic', 'Lactobacillus reuteri  DSM 17938 and Agave Inulin', 'placebo', 'DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received  L. reuteri  DSM 17938 plus agave inulin, and the placebo', 'Placebo', 'placebos']","['history of excessive stool retention, the presence of fecal mass', 'Stool consistency', 'stool pH', 'L. reuteri  concentration in feces']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0331584', 'cui_str': 'Agave'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",37.0,0.16112,"L. reuteri  concentration in feces was higher in the probiotic group than in the placebo group ( p  = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r  = -0.762,  p  = 0.028).","[{'ForeName': 'Andrea A García', 'Initials': 'AAG', 'LastName': 'Contreras', 'Affiliation': 'Departamento de Nutrición y Bienestar Integral, Escuela de Medicina, Instituto Tecnológico y de Estudios Superiores Monterrey Campus Guadalajara, C.P. 4520 Zapopan, Jalisco, Mexico.'}, {'ForeName': 'Edgar M Vásquez', 'Initials': 'EMV', 'LastName': 'Garibay', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Carmen A Sánchez', 'Initials': 'CAS', 'LastName': 'Ramírez', 'Affiliation': 'Departamento de la Facultad de Medicina, Facultad de Medicina, Universidad de Colima, C.P. 28040 Colima, Colima, Mexico.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fafutis Morris', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Delgado Rizo', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}]",Nutrients,['10.3390/nu12102971']
3033,32998769,"Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants-""The OPTTIMMAL-Trial""-Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial.","BACKGROUND


Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP) and has been shown to reduce the need for intubation and invasive mechanical ventilation in very low birth weight infants with respiratory distress syndrome. However, CPAP failure rates of 50% are reported in large randomized controlled trials. A possible explanation for these failure rates is the application of insufficient low levels of PEEP during nasal CPAP treatment to maintain adequate functional residual capacity shortly after birth. The optimum PEEP level to treat symptoms of respiratory distress in very low birth weight infants has not been assessed in clinical studies. The aim of the study is to compare two different PEEP levels during nasal CPAP treatment in preterm infants.
METHODS


In this randomized multicenter trial, 216 preterm infants born at 26 + 0-29 + 6 gestational weeks will be allocated to receive a higher (6-8 cmH 2 O) or a lower (3-5 cmH 2 O) PEEP during neonatal resuscitation and the first 120 h of life. The PEEP level within each group will be titrated throughout the intervention based on the FiO 2  (fraction of inspired oxygen concentration) requirements to keep oxygenation within the target range. The primary outcome is defined as the need for intubation and mechanical ventilation for > 1 h or being not ventilated but reaching one of the two pre-defined CPAP failure criteria (FiO 2  > 0.5 for > 1 h or pCO 2  ≥ 70 mmHg in two consecutive blood gas analyses at least 2 h apart).
DISCUSSION


Based on available data from the literature, the optimum level of PEEP that most effectively treats respiratory distress syndrome in preterm infants is unknown, since the majority of large clinical trials applied a wide range of PEEP levels (4-8 cmH 2 O). The rationale for our study hypothesis is that the early application of a higher PEEP level will more effectively counteract the collapsing properties of the immature and surfactant-deficient lungs and that the level of inspired oxygen may serve as a surrogate marker to guide PEEP titration. Finding the optimum noninvasive continuous distending pressure during early nasal CPAP is required to improve CPAP efficacy and as a consequence to reduce the exposure to ventilator-induced lung injury and the incidence of chronic lung disease in this vulnerable population of very preterm infants.
TRIAL REGISTRATION


drks.de DRKS00019940 . Registered on March 13, 2020.",2020,The PEEP level within each group will be titrated throughout the intervention based on the FiO 2  (fraction of inspired oxygen concentration) requirements to keep oxygenation within the target range.,"['preterm infants', 'very low birth weight infants with respiratory distress syndrome', 'very low birth weight infants', 'IMMAture Lungs', 'respiratory distress syndrome in preterm infants-""The', '216 preterm infants born at 26\u2009+\u20090-29\u2009+\u20096 gestational weeks']","['Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP', 'nasal CPAP treatment']","['CPAP efficacy', 'need for intubation and mechanical ventilation for >\u20091\u2009h or being not ventilated but reaching one of the two pre-defined CPAP failure criteria', 'CPAP failure rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0270163', 'cui_str': 'Primary atelectasis, in perinatal period'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",216.0,0.293847,The PEEP level within each group will be titrated throughout the intervention based on the FiO 2  (fraction of inspired oxygen concentration) requirements to keep oxygenation within the target range.,"[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Waitz', 'Affiliation': 'Department of General Pediatrics and Neonatology, Center for Child and Adolescent Medicine, Justus-Liebig-University, Feulgenstraße 12, 35392, Gießen, Germany. markus.waitz@paediat.med.uni-giessen.de.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Center for Pediatric Clinical Studies, University of Tübingen, Frondsbergstraße 23, 72070, Tübingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Schloesser', 'Affiliation': 'Division of Neonatology, University of Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Rochwalsky', 'Affiliation': 'Division of Neonatology, University of Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Pediatrics and Neonatology, Saarland University Medical Center, Kirrbergerstrasse 100, 66421, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Pediatrics and Neonatology, Saarland University Medical Center, Kirrbergerstrasse 100, 66421, Homburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hoffmann', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Pediatrics and Neonatology, Saarland University Medical Center, Kirrbergerstrasse 100, 66421, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Pediatrics and Neonatology, Saarland University Medical Center, Kirrbergerstrasse 100, 66421, Homburg, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bohnhorst', 'Affiliation': 'Division of Pediatric Pulmonology, Allergology and Neonatology Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Division of Pediatric Pulmonology, Allergology and Neonatology Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoppenz', 'Affiliation': 'Neonatology and Pediatric Intensive Care Medicine, Hospital Cologne, Amsterdamer Strasse 59, 50735, Köln, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Neonatology and Pediatric Intensive Care Medicine, Hospital Cologne, Amsterdamer Strasse 59, 50735, Köln, Germany.'}, {'ForeName': 'Klaus-Peter', 'Initials': 'KP', 'LastName': 'Zimmer', 'Affiliation': 'Department of General Pediatrics and Neonatology, Center for Child and Adolescent Medicine, Justus-Liebig-University, Feulgenstraße 12, 35392, Gießen, Germany.'}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': 'Center for Pediatric Clinical Studies, University of Tübingen, Frondsbergstraße 23, 72070, Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Haertel', 'Affiliation': ""University Children's Hospital, University of Würzburg, Josef-Schneider-Str. 2, 97080, Wuerzburg, Germany.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frieauff', 'Affiliation': ""University Children's Hospital, University of Würzburg, Josef-Schneider-Str. 2, 97080, Wuerzburg, Germany.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sandkötter', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, 48149, Muenster, Germany.""}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Masjosthusmann', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, 48149, Muenster, Germany.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Deindl', 'Affiliation': 'Division of Neonatology and Pediatric Intensive Care, Department of Pediatrics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Singer', 'Affiliation': 'Division of Neonatology and Pediatric Intensive Care, Department of Pediatrics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Heidkamp', 'Affiliation': 'Division of Neonatology and Pediatric Intensive Care, Department of Pediatrics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Annesuse', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of General Pediatrics and Neonatology, Center for Child and Adolescent Medicine, Justus-Liebig-University, Feulgenstraße 12, 35392, Gießen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of General Pediatrics and Neonatology, Center for Child and Adolescent Medicine, Justus-Liebig-University, Feulgenstraße 12, 35392, Gießen, Germany.'}]",Trials,['10.1186/s13063-020-04660-0']
3034,32998924,Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial.,"INTRODUCTION


Fungal infections of the cornea, fungal keratitis (FK), are challenging to treat. Current topical antifungals are not always effective and are often unavailable, particularly in low-income and middle-income countries where most cases occur. Topical natamycin 5% is usually first-line treatment, however, even when treated intensively, infections may progress to perforation of the eye in around a quarter of cases. Alternative antifungal medications are needed to treat this blinding disease.Chlorhexidine is an antiseptic agent with antibacterial and antifungal properties. Previous pilot studies suggest that topical chlorhexidine 0.2% compares favourably with topical natamycin. Full-scale randomised controlled trials (RCTs) of topical chlorhexidine 0.2% are warranted to answer this question definitively.
METHODS AND ANALYSIS


We will test the hypothesis that topical chlorhexidine 0.2% is non-inferior to topical natamycin 5% in a two-arm, single-masked RCT. Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2-6 random block size). Patients are reviewed at day 2, day 7 (with reculture), day 14, day 21, month 2 and month 3. The primary outcome is the best spectacle corrected visual acuity (BSCVA) at 3 months. Primary analysis (intention to treat) will be by linear regression, with treatment arm and baseline BSCVA prespecified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
ETHICS AND DISSEMINATION


The Nepal Health Research Council, the Nepal Department of Drug Administration and the London School of Hygiene and Tropical Medicine ethics committee have approved the trial. The results will be presented at local and international meetings and submitted to peer-reviewed journals for publication.
TRIAL REGISTRATION NUMBER


ISRCTN14332621; pre-results.",2020,"Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
","['Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal', 'fungal keratitis in Nepal']","['Topical chlorhexidine', 'topical natamycin', 'Topical natamycin', 'topical chlorhexidine', 'Chlorhexidine']","['epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF', 'best spectacle corrected visual acuity (BSCVA', 'history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0020641', 'cui_str': 'Hypopyon'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1832200', 'cui_str': 'Peroxisome biogenesis disorder'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0184933', 'cui_str': 'Scraping'}, {'cui': 'C0025952', 'cui_str': 'Microbiology'}]",,0.275982,"Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
","[{'ForeName': 'Jeremy John', 'Initials': 'JJ', 'LastName': 'Hoffman', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK jeremy.hoffman@lshtm.ac.uk.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Das Sanyam', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chaudhary', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Roshan', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Sanjay Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Eastern Region Eye Care Programme, Biratnagar, Nepal.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Arunga', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Einoti', 'Initials': 'E', 'LastName': 'Matayan', 'Affiliation': 'Department of Ophthalmology, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Leck', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Hu', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038066']
3035,32998926,"Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate.","INTRODUCTION


In patients with axial spondyloarthritis (axSpA), biological disease-modifying anti-rheumatic drugs (bDMARDs) are recommended to those with inadequate response or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs). In case of failure of the first bDMARD, a switch within the class or to other bDMARD is recommended. Despite these treatment options, there is no optimal treat-to-target (T2T) strategy. This study aims to evaluate the efficacy of a T2T strategy in patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment.
METHODS AND ANALYSES


This is a randomised, parallel-group, open-label, multicentre ongoing study in patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs. The study will include an 8-week screening period, a 36-week treatment period and a 20-week safety follow-up period. At baseline, patients will be randomised (1:1) to T2T or SOC group. In the T2T group, patients will be treated with secukinumab 150 mg subcutaneous (s.c.) weekly until week 4 and then at week 8. For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c. every 4 weeks until week 24. Non-responders at week 24 will be switched to adalimumab biosimilar 40 mg s.c. every 2 weeks until week 34. In the SOC group, patients will receive treatment at the discretion of the physician. The primary endpoint is the proportion of patients achieving an Assessment in SpondyloArthritis International Society 40% (ASAS40) response at week 24.
ETHICS AND DISSEMINATION


The study is being conducted as per the ethical principles of the Declaration of Helsinki and after approval from independent ethics committees/institutional review boards. The first results are expected to be published in early 2022.
TRIAL REGISTRATION NUMBER


This study is registered with ClinicalTrials.gov, NCT03906136.",2020,"For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c.","['patients with active axial spondyloarthritis', 'patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs', 'patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment', 'patients with axial spondyloarthritis (axSpA), biological disease-modifying anti-rheumatic drugs (bDMARDs']",['secukinumab'],['proportion of patients achieving an Assessment in SpondyloArthritis International Society 40% (ASAS40) response'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",,0.10501,"For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Head of the Rheumatology Unit Clinic of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany denis.poddubnyy@charite.de.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Hammel', 'Affiliation': 'Deutsche Vereinigung Morbus Bechterew e.V, Schweinfurt, Germany.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Heyne', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Veit', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Jentzsch', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-039059']
3036,32998931,Pancreatic resection with perioperative drug repurposing of propranolol and etodolac: trial protocol of the phase-II randomised placebo controlled PROSPER trial.,"INTRODUCTION


Pancreatic cancer is the fourth-leading cause of cancer-related death in developed countries. Despite advances in systemic chemotherapy, the mainstay of curative therapy for non-metastatic disease is surgical resection. However, the perioperative period is characterised by stress and inflammatory reactions that can contribute to metastatic spread and disease recurrence. Catecholamines and prostaglandins play a crucial role in these reactions. Therefore, a drug repurposing of betablockers and cyclooxygenase inhibitors seems reasonable to attenuate tumour-associated inflammation by inhibiting psychological, surgical and inflammatory stress responses. This may cause a relevant antitumourigenic and antimetastatic effect during the perioperative period, a window for cancer-directed therapy that is currently largely unexploited.
METHODS AND ANALYSIS


This is a prospective, single-centre, two-arm randomised, patient and observer blinded, placebo-controlled, phase-II trial evaluating safety and feasibility of combined perioperative treatment with propranolol and etodolac in adult patients with non-metastatic cancer of the pancreatic head undergoing elective pancreatoduodenectomy. 100 patients fulfilling the eligibility criteria will be randomised to perioperative treatment for 25 days perioperatively with a combination of propranolol and etodolac or placebo. Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months. Furthermore, adherence to trial medication will be assessed as feasibility outcomes. Preliminary efficacy data will be evaluated for the purpose of power calculation for a potential subsequent phase-III trial. The clinical trial is accompanied by a translational study investigating the mechanisms of action of the combined therapy on a molecular basis.
ETHICS AND DISSEMINATION


The PROSPER-trial has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042875) and the Ethics Committee of the Medical Faculty of the University of Heidelberg (reference number AFmo-385/2018). The final trial results will be published in a peer-reviewed journal and will be presented at appropriate national and international conferences.
TRIAL REGISTRATION NUMBERS


DRKS00014054; EudraCT number: 2018-000415-25.",2020,Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months.,"['100 patients fulfilling the eligibility criteria', 'adult patients with non-metastatic cancer of the pancreatic head undergoing elective pancreatoduodenectomy']","['propranolol and etodolac or placebo', 'propranolol and etodolac', 'cyclooxygenase inhibitors', 'placebo']",['safety in terms of serious adverse events and reactions within 3 months'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0227579', 'cui_str': 'Structure of head of pancreas'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085387', 'cui_str': 'Cyclooxygenase inhibitor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.267369,Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months.,"[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Rooman', 'Affiliation': 'The Anticancer Fund, Brussels, Belgium.'}, {'ForeName': 'Gauthier', 'Initials': 'G', 'LastName': 'Bouche', 'Affiliation': 'The Anticancer Fund, Brussels, Belgium.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hüsing', 'Affiliation': 'Coordination Center for Clinical Trials, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany markus.buechler@med.uni-heidelberg.de.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-040406']
3037,32998932,"Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement: study protocol for a randomised, controlled, double-blinded clinical trial.","INTRODUCTION


In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.
METHODS AND ANALYSIS


This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.
TRIAL REGISTRATION NUMBER


EudraCT: No 2015-001200-55; Pre-results.",2020,The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up.,"['Participants will be recruited from two orthopaedic departments', '1000 patients will be included in the study', 'patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis']","['bisphosphonates', 'placebo', 'Bisphosphonates', 'zoledronic acid']","['pain and loss of function', 'rate of revision for aseptic loosening', 'Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score']","[{'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}]",1000.0,0.415491,The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Brandt', 'Affiliation': 'Department of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ledin', 'Affiliation': 'Department of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Department of Clinical sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Syddansk Universitet Det Sundhedsvidenskabelige Fakultet, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aspenberg', 'Affiliation': 'Department of Orthopaedic Surgery, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schilcher', 'Affiliation': 'Department of Orthopaedic Surgery, Linköping University Hospital, Linköping, Sweden jorg.schilcher@liu.se.'}]",BMJ open,['10.1136/bmjopen-2020-040985']
3038,33000762,Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation.,"BACKGROUND


Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves.
OBJECTIVE


To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation.
METHODS


A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included.
RESULTS


The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021.
CONCLUSIONS


Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/21100.",2020,"Primary outcome at the adolescent level was identified as ""not having tried tobacco"" during the three-year junior high school compulsory grades (12-15 years of age).","['adolescents and/or promoting cessation among their parents', 'In total 43 schools were recruited to the experimental study and 16 schools were recruited to the observational study', 'schools participating in the experiment with that of a convenience sample of schools not being part of the experimental study']","['Swedish school-based program ""Tobacco-free Duo"" (TOPAS study', 'comprehensive multi-component program or to its educational component only']","['smoking prevalence', 'adolescent level was identified as ""not having tried tobacco']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",43.0,0.0328951,"Primary outcome at the adolescent level was identified as ""not having tried tobacco"" during the three-year junior high school compulsory grades (12-15 years of age).","[{'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anni-Maria', 'Initials': 'AM', 'LastName': 'Pulkki-Brännström', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}]",JMIR research protocols,['10.2196/21100']
3039,32997643,"Correction: Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial.",[This corrects the article DOI: 10.2196/18595.].,2020,[This corrects the article DOI: 10.2196/18595.].,"['University Students on Symptoms of Stress, Anxiety, and Depression']",['8-Week Web-Based Mindfulness Virtual Community Intervention'],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0492545,[This corrects the article DOI: 10.2196/18595.].,"[{'ForeName': 'Christo', 'Initials': 'C', 'LastName': 'El Morr', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}]",JMIR mental health,['10.2196/24131']
3040,32997684,A Short Message Service (SMS) increases postpartum care-seeking behavior and uptake of family planning of mothers in peri-urban public facilities in Kenya.,"BACKGROUND


It is estimated that one third of maternal deaths in Kenya in 2014 could have been prevented by more timely care-seeking. Mobile health interventions are increasingly being recognized as tools for the delivery of health education and promotion. Many maternal deaths occur in the first few weeks after delivery and mothers who are given adequate care in the postpartum period have better health outcomes. Kiambu County, Kenya has a high level of literacy and phone ownership amongst mothers delivering in public hospitals and was chosen as a site for a postpartum short message service intervention.
METHODS


Women were recruited after delivery and randomized to receive a package of mobile messages or standard of care only. Messages covered danger signs, general postpartum topics, and family planning. Endline phone surveys were conducted at 8 weeks postpartum to assess knowledge, care seeking behavior and family planning uptake. Analysis was conducted using Stata and is presented in odds ratios.
RESULTS


Women who received the danger sign messages were 1.6 times more likely to be able to list at least 1 danger sign and 3.51 times more likely to seek treatment if they experienced postpartum danger signs. There was no significant difference in routine postpartum care seeking or care seeking behaviors concerning newborns. Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
CONCLUSIONS


Simple, low-cost mobile interventions can support women in the early postpartum period when the information is targeted to particular points in the postpartum continuum. Additional research is needed to understand the interplay between healthcare providers and mobile health interventions. Health policy makers should consider direct mobile interventions for women as an option for supporting positive maternal health outcomes in certain populations.",2020,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","['Women', 'mothers in peri-urban public facilities in Kenya']","['package of mobile messages or standard of care only', 'Short Message Service (SMS']","['uptake family planning services', 'routine postpartum care seeking or care seeking behaviors concerning newborns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034018', 'cui_str': 'Public facilities'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",,0.0717481,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kimenju', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Subbiah', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Styles', 'Affiliation': 'Independent Researcher, Nairobi, Kenya.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Sathyanath', 'Initials': 'S', 'LastName': 'Rajasekharan', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}]",PloS one,['10.1371/journal.pone.0239213']
3041,33002541,Cost-Effectiveness Analysis of Stereotactic Ablative Radiation Therapy in Patients With Oligometastatic Cancer.,"PURPOSE


The Stereotactic Ablative Radiation therapy for Comprehensive Treatment of Oligometastatic Tumors phase 2 randomized clinical trial found that stereotactic ablative radiation therapy (SABR) improved outcomes among cancer patients with oligometastatic disease. Yet, the cost of SABR along with the large number of patients with oligometastatic disease raises the important question of value. This study sought to evaluate the cost-effectiveness of the addition of SABR compared with standard therapy alone among cancer patients with oligometastatic disease.
METHODS AND MATERIALS


We constructed a Markov model to simulate treatment with stereotactic ablative radiation therapy or standard therapy among patients with oligometastatic cancers. The model derived transition probabilities from Stereotactic Ablative Radiation therapy for Comprehensive Treatment of Oligometastatic Tumors clinical trial data to estimate risks of toxicity, disease progression and survival. Health care costs and health utilities were estimated from the literature. Probabilistic and one-way sensitivity analyses evaluate model uncertainty. Cost-effectiveness was estimated from both the health care sector and societal perspectives with an incremental cost-effectiveness ratio (ICER) defined as dollars per quality-adjusted life year (QALY). An ICER less than $100,000/QALY was considered cost-effective. One-way and probabilistic sensitivity analyses were used to examine model uncertainty.
RESULTS


The addition of SABR increased total costs by $54,260 (health care sector perspective) or $72,799 (societal perspective) and improved effectiveness by 1.88 QALYs compared with standard therapy, leading to an ICER of $28,906/QALY (health care sector perspective) or $38,783/QALY (societal perspective). The model was modestly sensitive to assumptions about tumor progression, although the model was not sensitive to assumptions about survival or cost of treatment. Probabilistic sensitivity analyses demonstrated that SABR was the cost-effective treatment option 99.8% (health care sector perspective) or 98.7% (societal perspective) of the time.
CONCLUSIONS


The addition of SABR increased costs and improved quality adjusted survival, overall leading to a cost-effective treatment strategy for patients with oligometastatic cancer.",2020,"Probabilistic sensitivity analyses demonstrated that SABR was the cost-effective treatment option 99.8% (health care sector perspective) or 98.7% (societal perspective) of the time.
","['Patients with Oligometastatic Cancer', 'patients with oligometastatic cancer', 'cancer patients with oligometastatic disease', 'patients with oligometastatic cancers']","['stereotactic ablative radiotherapy or standard therapy', 'stereotactic ablative radiotherapy (SABR', 'SABR', 'Stereotactic Ablative Radiotherapy']","['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER', 'quality adjusted survival', 'toxicity, disease progression and survival', 'Healthcare costs and health utilities', 'total costs', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0462217,"Probabilistic sensitivity analyses demonstrated that SABR was the cost-effective treatment option 99.8% (health care sector perspective) or 98.7% (societal perspective) of the time.
","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Straka', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Courtney', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Vitzthum', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Riviere', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Murphy', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address: j2murphy@health.ucsd.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.09.045']
3042,33002792,Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial.,"BACKGROUND


Early rehabilitation has been proved very important for stroke patients. However, the effective model of transitioning from early in-hospital rehabilitation to discharge rehabilitation using the collaborative remote rehabilitation nursing model has not been thoroughly studied.
OBJECTIVE


To explore the feasibility and effectiveness of collaborative care model based telerehabilitation exercise training for acute stroke patients.
METHODS


A randomized controlled clinical trial was conducted. Patients were recruited and randomly divided into intervention and control group. Both groups were given regular treatment and acute rehabilitation nursing instructions during hospitalization. The control group was followed by regular telephone follow-up after discharge. The intervention group received Internet-based remote rehabilitation project after discharge. Motor function, balance ability and quality of life were measured at the day of discharge, the 4 th  week, 8 th  week and 12 th  week after patients were discharged. The CONSORT checklist was used to check the procedure.
RESULTS


A total of 61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group. Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78). Group-time interaction was significant in motor function and quality of life.
CONCLUSION


Collaborative care model based telerehabilitation exercise training program can safely and effectively improve the recovery of motor function and improve the quality of life in patients with stroke.",2020,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","['Acute Stroke Patients in China', 'acute stroke patients', 'stroke patients', '61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group', 'patients with stroke']","['Collaborative Care Model Based Telerehabilitation Exercise Training Program', 'collaborative care model based telerehabilitation exercise training', 'Internet-based remote rehabilitation project']","['Fugl-Meyer Motor Function Assessment', 'Berg Balance Scale', 'motor function and quality of life', 'Motor function, balance ability and quality of life', 'quality of life', 'Stroke-Specific Quality of Life Scale', 'recovery of motor function']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",61.0,0.0446921,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","[{'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 958414840@qq.com.'}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Outpatient Office, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 13255107918@163.com.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 1210906885@qq.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Tzu Chi elderly care service center, Changzhou, Jiangsu, China. Electronic address: 18262284203@qq.com.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of nursing, Taihu University of Wuxi, Wuxi, Jiangsu, China. Electronic address: yongchun0526@163.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105328']
3043,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE


The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN


A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING


Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS


63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS


All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES


Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS


Significant interaction Group*Time effects scales (F 2,126  = 5.1, p-level = 0.005, η² p  = 0.25; F 2,126  = 4.7, p-level = 0.007, η² p  = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION


The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
3044,33003338,"The Effects of a Functional Food Breakfast on Gluco-Regulation, Cognitive Performance, Mood, and Satiety in Adults.","A whole diet which combines multiple functional foods benefits metabolic risk factors and cognition, but evidence supporting meal to meal benefits, which individuals may find easier to implement, is limited. This study developed a functional food breakfast (FB), using polyphenol-rich ingredients selected for their gluco-regulating and cognitive-enhancing properties, and compared it to a control breakfast (CB). For study 1, total polyphenols were determined using the Folin-Ciocalteu method, and sugar release by in vitro digestion, in frozen and fresh samples. In study 2, healthy adults ( n  = 16) consumed an FB, CB and ready-to-eat breakfast cereal (RTEC) in a randomised crossover design. Glucose (GR) and insulin response (IR), satiety, mood and memory were measured over 180 min. The FB was a rich source of polyphenols (230 mg) compared to the CB (147 mg) ( p  < 0.05), and using frozen muffins did not compromise the polyphenol content or sugar release. Peak GR was highest after the RTEC ( p  < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p  < 0.05). There were no effects on GR AUC, mood, satiety or memory. Reductions in GR peak and IR following consumption of the FB support the inclusion of functional ingredients at breakfast.",2020,"Peak GR was highest after the RTEC ( p  < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p  < 0.05).","['Adults', 'healthy adults ( n  = 16) consumed an']","['Functional Food Breakfast', 'FB, CB and ready-to-eat breakfast cereal (RTEC', 'functional food breakfast (FB']","['insulin area under the curve (AUC', 'Peak GR', 'Glucose (GR) and insulin response (IR), satiety, mood and memory', 'Gluco-Regulation, Cognitive Performance, Mood, and Satiety', 'GR AUC, mood, satiety or memory', 'polyphenol content or sugar release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2717755', 'cui_str': 'Functional Food'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0331968,"Peak GR was highest after the RTEC ( p  < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p  < 0.05).","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Kennedy', 'Affiliation': 'Functional Food Centre, Oxford Brookes University, Oxford OX3 0BP, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ryan', 'Affiliation': 'School of Science and Computing, Galway-Mayo Institute of Technology, H91 T8NW Galway, Ireland.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Clegg', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading RG6 6DZ, UK.'}]",Nutrients,['10.3390/nu12102974']
3045,33003389,Obese Older Type 2 Diabetes Mellitus Patients with Muscle Insulin Resistance Benefit from an Enriched Protein Drink during Combined Lifestyle Intervention: The PROBE Study.,"(1) Background: Recent research showed that subtypes of patients with type 2 diabetes may differ in response to lifestyle interventions based on their organ-specific insulin resistance (IR). (2) Methods: 123 Subjects with type 2 diabetes were randomized into 13-week lifestyle intervention, receiving either an enriched protein drink (protein+) or an isocaloric control drink (control). Before and after the intervention, anthropometrical and physiological data was collected. An oral glucose tolerance test was used to calculate indices representing organ insulin resistance (muscle, liver, and adipose tissue) and β-cell functioning. In 82 study-compliant subjects (per-protocol), we retrospectively examined the intervention effect in patients with muscle IR (MIR,  n  = 42) and without MIR (no-MIR,  n  = 40). (3) Results: Only in patients from the MIR subgroup that received protein +  drink, fasting plasma glucose and insulin, whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control. Lifestyle intervention improved body weight and fat mass in both subgroups. Furthermore, for the MIR subgroup decreased systolic blood pressure and increased VO 2 peak and for the no-MIR subgroup, a decreased 2-h glucose concentration was found. (4) Conclusions: Enriched protein drink during combined lifestyle intervention seems to be especially effective on increasing muscle mass and improving insulin resistance in obese older, type 2 diabetes patients with muscle IR.",2020,"whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control.","['patients with muscle IR (MIR,  n  = 42) and without MIR (no-MIR,  n  = 40', 'obese older, type 2 diabetes patients with muscle IR', 'Obese Older Type 2 Diabetes Mellitus Patients with Muscle Insulin Resistance Benefit from an Enriched', '123 Subjects with type 2 diabetes']","['Protein Drink during Combined Lifestyle Intervention', 'Lifestyle intervention', 'lifestyle intervention, receiving either an enriched protein drink (protein+) or an isocaloric control drink (control']","['2-h glucose concentration', 'systolic blood pressure', 'body weight and fat mass', 'fasting plasma glucose and insulin', 'organ insulin resistance (muscle, liver, and adipose tissue) and β-cell functioning', 'whole body, liver and adipose IR, and appendicular skeletal muscle mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",123.0,0.0183175,"whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control.","[{'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Memelink', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Vogel-Van den Bosch', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Mark P V', 'Initials': 'MPV', 'LastName': 'Begieneman', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'van den Brink', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}]",Nutrients,['10.3390/nu12102979']
3046,33003436,Hospitalization for Acute Respiratory Tract Infection in a Low-Antibiotic-Prescribing Setting: Cross-Sectional Data from General Practice.,"BACKGROUND


Acute respiratory tract infections (ARTI) are the main cause of inappropriate antibiotic prescribing. To date, there is limited evidence concerning whether low levels of antibiotic prescribing may impact patient safety. We investigate whether antibiotic prescribing for patients seeking primary care for ARTI correlates with the odds for hospitalization.
METHODS


Analysis of patient baseline data ( n  = 3669) within a cluster-randomized controlled trial. Adult patients suffering from ARTI in German primary care are included. The main outcome measure is acute hospitalization for respiratory infection and for any acute disease from 0 to 42 days after initial consultation.
RESULTS


Neither the antibiotic status of individual patients (OR 0.91; 95% CI: 0.49 to 1.69;  p -value = 0.769) nor the physician-specific antibiotic prescription rates for ARTI (OR 1.22; 95% CI: 1.00 to 1.49;  p -value = 0.054) had a significant effect on hospitalization. The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
CONCLUSIONS


In a low-antibiotic-prescribing primary care setting such as Germany, lack of treatment with antibiotics for ARTI did not result in higher odds for hospitalization in an adult population.",2020,"The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
","['Adult patients suffering from ARTI in German primary care', 'Analysis of patient baseline data ( n  = 3669) within a cluster-randomized controlled trial', 'patients seeking primary care for ARTI correlates with the odds for hospitalization']",['antibiotic prescribing'],"['hospitalization', 'acute hospitalization for respiratory infection and for any acute disease', 'physician-specific antibiotic prescription rates for ARTI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0001314', 'cui_str': 'Acute disease'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}]",,0.0829148,"The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
","[{'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Löffler', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Diener', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Berner', 'Affiliation': 'Department of Pediatrics, University Hospital Carl Gustav Carus, TU, 01307 Dresden, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Feldmeier', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Helbig', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Winfried V', 'Initials': 'WV', 'LastName': 'Kern', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Medical Center, University of Freiburg, 79085 Freiburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Köchling', 'Affiliation': 'Clinic of Psychosomatic Medicine and Psychotherapy, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Medical Center, University of Freiburg, 79085 Freiburg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schön', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'AOK Research Institute (WIdO), 10178 Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Wollny', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100653']
3047,33003524,"Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes.","The accuracy of continuous glucose monitoring (CGM) sensors may be significantly impacted by exercise. We evaluated the impact of three different types of exercise on the accuracy of the Dexcom G6 sensor. Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor. Participants were randomized to aerobic, resistance, or high intensity interval training (HIIT) exercise. Each participant completed two in-clinic 30-min exercise sessions. The sensors were applied on average 5.3 days prior to the in-clinic visits (range 0.6-9.9). Capillary blood glucose (CBG) measurements with a Contour Next meter were performed before and after exercise as well as every 10 min during exercise. No CGM calibrations were performed. The median absolute relative difference (MARD) and median relative difference (MRD) of the CGM as compared with the reference CBG did not differ significantly from the start of exercise to the end exercise across all exercise types (ranges for aerobic MARD: 8.9 to 13.9% and MRD: -6.4 to 0.5%, resistance MARD: 7.7 to 14.5% and MRD: -8.3 to -2.9%, HIIT MARD: 12.1 to 16.8% and MRD: -14.3 to -9.1%). The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.",2020,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","['Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor', 'Adults with Type 1 Diabetes']","['aerobic, resistance, or high intensity interval training (HIIT) exercise']","['accuracy of continuous glucose monitoring (CGM) sensors', 'median absolute relative difference (MARD) and median relative difference (MRD', 'Capillary blood glucose (CBG) measurements']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0233425,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","[{'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Guillot', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph El', 'Initials': 'JE', 'LastName': 'Youssef', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Gabo', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Branigan', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Nichole S', 'Initials': 'NS', 'LastName': 'Tyler', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Clinical and Translational Research Institute Biostatistics & Design Program, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'Muscle Health Research Centre, School of Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}]",Biosensors,['10.3390/bios10100138']
3048,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
3049,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM


During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS


Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS


From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS


The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto L R', 'Initials': 'ULR', 'LastName': 'Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
3050,33028455,A randomised test of the effect of medical  v . lay idiom on assessment of perceived mental health condition in the USA.,"AIMS


To test the impact of using different idioms in epidemiological interviews on the prevalence and correlates of poor mental health and mental health service use.
METHODS


We conducted a randomised methodological experiment in a nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health'. Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
RESULTS


Respondents were about half as likely to endorse a problem when asked with the more medical idiom (18.1%) than when asked with the lay idiom (35.1%). The medical idiom had a significantly larger area under the ROC curve when compared against a validated measure of psychological distress than the lay idiom (0.91 v. 0.87, p = 0.012). The proportion of the population who endorsed a problem but did not receive treatment in the past year was less than half as large for the medical idiom (7.90%) than for the lay idiom (20.94%). Endorsement of problems differed in its associations with age, sex, race/ethnicity and self-rated health depending on the question idiom. For instance, the odds of endorsing problems were threefold higher in the youngest than the oldest age group when the medical idiom was used (OR = 3.07; 95% CI 1.47-6.41) but did not differ across age groups when the lay idiom was used (OR = 0.76; 95% CI 0.43-1.36).
CONCLUSION


Choice of idiom in epidemiological questionnaires can affect the apparent correlates of poor mental health and service use. Cultural change within populations over time may require changes in instrument wording to maintain consistency in epidemiological measurement of psychiatric conditions.",2020,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[""nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health""]",['medical  v . lay idiom'],"['psychological distress', 'psychological distress), demographic characteristics, self-rated health and mental health service use', 'odds of endorsing problems', 'larger area under the ROC curve']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",,0.0553389,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breslau', 'Affiliation': 'RAND Corporation, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McBain', 'Affiliation': 'RAND Corporation, Boston, Massachusetts, USA.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Wong', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Burnam', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cefalu', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Collins', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000840']
3051,32997871,"A randomized, controlled pilot study of cognitive analytic therapy for stressed pregnant women with underlying anxiety and depression in a routine health service setting.","A pilot study of cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU in stressed pregnant women with anxiety and depression, was undertaken as an essential preliminary to any definitive, randomized controlled trial (RCT). The trial was pragmatic, multicentre, parallel, randomized, controlled, and unblinded. Participants were pregnant women screened using the Hospital Anxiety and Depression Scale (HADS). Treatment was standard 16-session CAT. Main outcome measures were Spielberger State/Trait Anxiety Inventory (STAI) (primary outcome measure) at 24 weeks after randomization, therefore 1 month after therapy for the CAT group; HADS; Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM); Edinburgh Postnatal Depression Scale (EPDS); 36-item Short Form Health Survey (SF-36); and a brief Experiences of Therapy Questionnaire, completed at baseline and on average at 12, 24, 40, and 82 weeks after randomization. Thirty-nine patients (CAT + TAU, n = 20; TAU, n = 19) were randomized with mean baseline STAI State scores of 50.8 (SD 11.4) and 51.1 (SD 13.3), respectively. Sixteen patients had missing primary outcome data leaving 23 (n = 11 and n = 12) patients for analysis. The mean STAI State score was 38.5 (SD 13.8) and 45.7 (SD 16.8) in the CAT and TAU groups respectively at 24 weeks after randomization, with an adjusted difference in means of 7.2 (95% confidence interval [CI]: -7.9 to 20.6). No safety issues were reported. Patient retention for the CAT group was high (18/20; 90% of patients completed therapy). Ten out of 11 (90.9%) respondents 'agreed' or 'strongly agreed' that having CAT had been 'very helpful'. The study demonstrated the feasibility of safely undertaking CAT in this setting. Outcomes showed positive trends compatible with a clinically important effect, although statistically definitive conclusions cannot be drawn in such a study.",2020,No safety issues were reported.,"['39 patients (CAT + TAU n=20: TAU =19', 'stressed pregnant women with underlying anxiety and depression in a routine health service setting', 'stressed pregnant women with anxiety and depression', '16 patients had missing primary outcome data leaving 23 (n=11, n=12) patients for analysis', 'Participants were pregnant woman screened using the']","['cognitive analytic therapy (CAT', 'cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU']","['Hospital Anxiety and Depression Scale (HADS', 'mean STAI-STATE score', ""HADS; CORE-OM, EPDS; SF36, and a brief 'experience of therapy' questionnaire"", 'Patient retention', 'Spielberger State/Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272257', 'cui_str': 'Cognitive analytic therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C1272257', 'cui_str': 'Cognitive analytic therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.257402,No safety issues were reported.,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychiatry, Sheffield Care and Social NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saxon', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Best', 'Affiliation': 'Department of Perinatal Psychiatry/MIMHS, Kent and Medway NHS & Social Care Partnership Trust, Maidstone, UK.'}, {'ForeName': 'Vivette', 'Initials': 'V', 'LastName': 'Glover', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Imperial College London, London, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Kerr', 'Affiliation': 'Department of Psychotherapy, Sheffield Care and Social NHS Foundation Trust, Sheffield, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2520']
3052,33002644,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,,2020,,['Dementia with Lewy Bodies'],['Bilateral Nucleus Basalis of Meynert D Brain Stimulation'],[],"[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]",[],,0.259573,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping Road, Weihai, Shandong, China, 264200. Electronic address: liuwei881x@outlook.com.'}, {'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Weihai Municipal Third Hospital, Weihai, Shandong, China, 264205. Electronic address: yudongyan@outlook.com.'}]",Brain stimulation,['10.1016/j.brs.2020.09.020']
3053,33002645,Enhancing cognitive training effects in Alzheimer's disease: rTMS as an add-on treatment.,"The treatment of Alzheimer's disease (AD) in the field of non-pharmacological interventions is a challenging issue, given the limited benefits of the available drugs. Cognitive training (CT) represents a commonly recommended strategy in AD. Recently, repetitive transcranial magnetic stimulation (rTMS) has gained increasing attention as a promising therapeutic tool for the treatment of AD, given its ability of enhancing neuroplasticity. In the present randomized, double-blind, sham-controlled study, we aimed at investigating the add-on effect of a high frequency rTMS protocol applied over the left dorsolateral prefrontal cortex (DLPFC) combined with a face-name associative memory CT in the continuum of AD pathology. Fifty patients from a very early to a moderate phase of dementia were randomly assigned to one of two groups: CT plus real rTMS or CT plus placebo rTMS. The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone. Interestingly, the extent of the additional improvement was affected by disease severity and levels of education, with less impaired and more educated patients showing a greater benefit. When testing for generalization to non-trained cognitive functions, results indicated that patients in CT-real group showed also a greater improvement in visuospatial reasoning than those in the CT-sham group. Interestingly, this improvement persisted over 12 weeks after treatment beginning. The present study provides important hints on the promising therapeutic use of rTMS in AD.",2020,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"['Fifty patients from a very early to a moderate phase of dementia', ""Alzheimer's disease""]","['rTMS', 'CT plus real rTMS or CT plus placebo rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Cognitive training (CT']","['visuospatial reasoning', 'disease severity and levels of education', 'trained associative memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",50.0,0.0608235,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bagattini', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. Electronic address: chiara.bagattini@cognitiveneuroscience.it.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barocco', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caffarra', 'Affiliation': 'Department of Medicine and Surgery, Section of Neuroscience, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Brignani', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Miniussi', 'Affiliation': 'Center for Mind/Brain Sciences- CIMeC, University of Trento, 38068, Rovereto, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Defanti', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}]",Brain stimulation,['10.1016/j.brs.2020.09.010']
3054,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND


Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD


Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS


One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION


To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
3055,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
3056,33003299,The GReat-Child Trial TM : A Quasi-Experimental Dietary Intervention among Overweight and Obese Children.,"Diet composition is a key determinant of childhood obesity. While whole grains and micronutrients are known to decrease the risk of obesity, there are no interventions originating from Southeast Asia that emphasize whole grain as a strategy to improve overall quality of diet in combating childhood obesity. The GReat-Child Trial aimed to improve whole grain intake and quality of diet among overweight and obese children. It is a quasi-experimental intervention based on Social Cognitive Theory. It has a 12-week intervention and 6-month follow-up, consisting of three components that address environmental, personal, and behavioral factors. The intervention consists of: (1) six 30 min lessons on nutrition, using the Malaysian Food Pyramid to emphasize healthy eating, (2) daily deliveries of wholegrain foods to schools so that children can experience and accept wholegrain foods, and (3) diet counseling to parents to increase availability of wholegrain foods at home. Two primary schools with similar demographics in Kuala Lumpur were assigned as control (CG) and intervention (IG) groups. Inclusion criteria were: (1) children aged 9 to 11 years who were overweight/obese; (2) who did not consume whole grain foods; and (3) who had no serious co-morbidity problems. The entire trial was completed by 63 children (31 IG; 32 CG). Study outcomes were measured at baseline and at two time points post intervention (at the 3rd [T1] and 9th [T2] months). IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75,  p  < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73,  p  = 0.001), calcium (mean difference = 130.27, 95%CI: 74.15, 186.39,  p  < 0.001), thiamin (mean difference = 58.71, 95%CI: 26.15, 91.28,  p  = 0.001), riboflavin (mean difference = 0.84, 95%CI: 0.37, 1.32,  p  = 0.001), niacin (mean difference = 0.35, 95%CI: 1.91, 5.16,  p  < 0.001), and vitamin C (mean difference = 58.71, 95%CI: 26.15, 91.28,  p  = 0.001) compared to CG in T1, after adjusting for covariates. However, T1 results were not sustained in T2 when intervention had been discontinued. The findings indicate that intervention emphasizing whole grains improved overall short-term but not long-term dietary intake among schoolchildren. We hope the present trial will lead to adoption of policies to increase whole grain consumption among Malaysian schoolchildren.",2020,"IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75,  p  < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73,  ","['overweight and obese children', 'Inclusion criteria were: (1) children aged 9 to 11 years who were overweight/obese; (2) who did not consume whole grain foods; and (3) who had no serious co-morbidity problems', 'Two primary schools with similar demographics in Kuala Lumpur', 'Overweight and Obese Children', 'Malaysian schoolchildren']","['Quasi-Experimental Dietary Intervention', 'Malaysian Food Pyramid to emphasize healthy eating, (2) daily deliveries of wholegrain foods to schools so that children can experience and accept wholegrain foods, and (3) diet counseling to parents to increase availability of wholegrain foods at home', 'niacin']","['riboflavin', 'intakes of whole grain', 'vitamin C']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]",1.0,0.066454,"IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75,  p  < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73,  ","[{'ForeName': 'Hui Chin', 'Initials': 'HC', 'LastName': 'Koo', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}, {'ForeName': 'Bee Koon', 'Initials': 'BK', 'LastName': 'Poh', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}, {'ForeName': 'Ruzita Abd', 'Initials': 'RA', 'LastName': 'Talib', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}]",Nutrients,['10.3390/nu12102972']
3057,33003302,"Preoperative or Perioperative Docetaxel, Oxaliplatin, and Capecitabine (GASTRODOC Regimen) in Patients with Locally-Advanced Resectable Gastric Cancer: A Randomized Phase-II Trial.","Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively ( p =  0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18-1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B ( p =  0.300). Five-year survival was 58.5% (95% CI: 41.3-72.2) and 53.9% (95% CI: 35.5-69.3) ( p =  0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.",2020,Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B ( p =  0.300).,"['Ninety-one patients were enrolled between September 2010 and August 2016', 'patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology', 'Patients with Locally-Advanced Resectable Gastric Cancer']","['Docetaxel', 'neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B', 'Preoperative or Perioperative Docetaxel, Oxaliplatin, and Capecitabine', 'oxaliplatin and 5-fluorouracil (FLOT']","['Five-year survival', 'tolerated', 'Five-year progression-free survival (PFS', 'percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C3472243', 'cui_str': 'Laparoscopy and peritoneal lavage'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]",91.0,0.105526,Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B ( p =  0.300).,"[{'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Morgagni', 'Affiliation': 'Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Framarini', 'Affiliation': 'Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Saragoni', 'Affiliation': 'Pathology Unit, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Marrelli', 'Affiliation': 'Unit of Surgical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Roviello', 'Affiliation': 'Unit of Surgical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Petrioli', 'Affiliation': 'Unit of Medical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Fumagalli Romario', 'Affiliation': 'European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, 20089 Rozzano (Milan), Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bozzarelli', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, 20089 Rozzano (Milan), Italy.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Donini', 'Affiliation': 'General and Emergency Surgery, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy.'}, {'ForeName': 'Luigina', 'Initials': 'L', 'LastName': 'Graziosi', 'Affiliation': 'General and Emergency Surgery, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'De Angelis', 'Affiliation': 'Clinical Oncology, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Manzoni', 'Affiliation': 'General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bencivenga', 'Affiliation': 'General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mengardo', 'Affiliation': 'General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Parma', 'Affiliation': 'Department of Surgery, San Giuseppe Hospital, 50053 Empoli, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Milandri', 'Affiliation': 'Department of Oncology, San Giuseppe Hospital, 50053 Empoli, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Mura', 'Affiliation': 'Department of General Surgery, San Donato Hospital, 52100 Arezzo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Signorini', 'Affiliation': 'Department of Oncology, Valdarno Hospital, 52025 Montevarchi, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Clinical and Experimental Sciences, Surgical Clinic, University of Brescia, 25121 Brescia, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Molfino', 'Affiliation': 'Department of Clinical and Experimental Sciences, Surgical Clinic, University of Brescia, 25121 Brescia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sgroi', 'Affiliation': 'Surgical Oncology Unit, Surgery Department, ASST Bergamo Ovest, 24047 Treviglio, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Steccanella', 'Affiliation': 'Surgical Oncology Unit, Surgery Department, ASST Bergamo Ovest, 24047 Treviglio, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rausei', 'Affiliation': 'First Division of Surgery, Senology Research Center, Department of Surgical and Morphological Sciences, University of Insubria, 21100 Varese, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Proserpio', 'Affiliation': 'Medical Oncology, Ospedale di Circolo e Fondazione Macchi, 21100 Varese, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Viganò', 'Affiliation': 'General Surgery, IRCCS San Matteo, 27100 Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Brugnatelli', 'Affiliation': 'Medical Oncology Unit, IRCCS San Matteo, 27100 Pavia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rinnovati', 'Affiliation': 'General Surgery Unit, Ospedale del Casentino, 52010 Bibbiena, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Santi', 'Affiliation': 'Department of Gastroenterology, Esophageal Surgery Unit, Tuscany Regional Referral Center for the Diagnosis and Treatment of Esophageal Disease, 56126 Pisa, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ercolani', 'Affiliation': 'Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Foca', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Valmorri', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}, {'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.'}]",Cancers,['10.3390/cancers12102790']
3058,33006062,"Efficacy and Safety of Ivabradine Once-Daily Prolonged-Release versus Twice-Daily Immediate-Release Formulation in Patients with Stable Chronic Heart Failure with Systolic Dysfunction: A Randomized, Double-Blind, Phase 3 Non-Inferiority (PROFICIENT) Study.","INTRODUCTION


Dosing frequency is an important factor influencing medication compliance in patients with heart failure (HF), which in turn is imperative in achieving the desired therapeutic outcome. Here we assessed the efficacy and safety of ivabradine prolonged-release (PR) once-daily (test) vs. ivabradine immediate-release (IR) twice-daily (reference) formulations in patients with stable chronic HF with systolic dysfunction.
METHODS


Patients with sinus rhythm and heart rate (HR) ≥ 50 bpm, left ventricular ejection fraction ≤ 40% (HF with reduced ejection fraction), on guideline-based standard care, receiving a stable dose of ivabradine IR 5/7.5 mg twice daily for ≥ 1 month were enrolled in this randomized, double-blind, phase 3 non-inferiority study. Patients were randomly assigned 1:1 to ivabradine PR (10 mg/15 mg) based on the ivabradine IR dosage or continued ivabradine IR (5 mg/7.5 mg). The primary endpoint was change in resting ECG HR from baseline to the end of 3 months, assessed by 12-lead ECG. Safety assessments and 24-h Holter HR monitoring (in a subgroup of patients) were also performed. Non-inferiority was concluded if the upper limit of the 95% CI of the difference between the test and reference was less than the margin of 6.5 bpm in the per-protocol set.
RESULTS


A total of 169 out of 180 randomized patients (93.9%) completed the study (PR = 84; IR = 85). The least-square mean (standard error [SE]) for change in HR from baseline to 3 months was 0.76 (1.188; 95% CI -1.59:3.11) in ivabradine PR vs. ivabradine IR, which was within the pre-specified margin of 6.5 bpm, confirming the non-inferiority of ivabradine PR. The change from baseline to 3 months was comparable between the treatment groups for 24-h Holter ECG monitoring (p = 0.3701), mean HR awake (p = 0.3423), and mean HR asleep (p = 0.1501). Thirty-nine treatment-emergent adverse events (TEAEs) were reported; the majority in both groups were of mild or moderate severity and were subsequently resolved. Seven serious adverse events were reported (ivabradine PR = 2; ivabradine IR = 5), of which one was fatal (ivabradine IR group). The bradycardia events reported were comparable between groups.
CONCLUSION


Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile. Once-daily ivabradine PR effectively maintained the HR in patients shifted from the ivabradine IR twice-daily regimen, and thus may aid in improving treatment compliance.
TRIAL REGISTRATION


CTRI/2018/04/013464 (Trial Registered Prospectively on 24/04/2018).",2020,"Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile.","['patients with heart failure (HF', 'patients with stable chronic HF with systolic dysfunction', 'Patients with Stable Chronic Heart Failure with Systolic Dysfunction', 'A total of 169 out of 180 randomized patients (93.9%) completed the study (PR\u2009=\u200984; IR\u2009=\u200985', 'Patients with sinus rhythm and heart rate (HR)\u2009≥\u200950\xa0bpm, left ventricular ejection fraction\u2009≤\u200940% (HF with reduced ejection fraction), on guideline-based standard care, receiving a stable dose of']","['Ivabradine Once-Daily Prolonged-Release versus Twice-Daily Immediate-Release Formulation', 'ivabradine prolonged-release (PR) once-daily (test) vs. ivabradine immediate-release (IR) twice-daily (reference) formulations', 'ivabradine IR 5/7.5\xa0mg twice daily for\u2009≥', 'ivabradine IR dosage or continued ivabradine IR', 'Ivabradine PR', 'ivabradine PR']","['efficacy and safety', 'Efficacy and Safety', 'mean HR asleep', 'bradycardia events', 'Safety assessments and 24-h Holter HR monitoring', 'change in resting ECG HR', 'Seven serious adverse events', 'mean HR awake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]",180.0,0.129954,"Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile.","[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Mullasari', 'Affiliation': 'Madras Medical Mission, Mogappair, Chennai, Tamil Nadu, 300037, India. sulu_ajit57@yahoo.co.in.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-020-00200-8']
3059,33007442,Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.,"INTRODUCTION


The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.
OBJECTIVE


To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.",2020,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.",['older adults in intensive care units'],"['PCplanner intervention', 'PCplanner vs. usual care']","['goal concordance of care, patient-centeredness of care, and quality of communication at 1\u202fweek post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder', 'change in unmet palliative care needs measured by the NEST instrument']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.166302,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Casarett', 'Affiliation': 'Department of Medicine, Section of Palliative Care and Hospice Medicine, Duke University, Durham, NC, United States of America. Electronic address: David.casarett@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North, Carolina;, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Raquel R', 'Initials': 'RR', 'LastName': 'Bartz', 'Affiliation': 'Department of Anesthesia, Division of Critical Care Medicine, Duke University, Durham, NC, United States of America. Electronic address: raquel.bartz@duke.edu.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: jason.katz@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Deepshikha', 'Initials': 'D', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gilstrap', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: daniel.gilstrap@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parish', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America. Electronic address: alice.parish@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Krishnamaneni', 'Affiliation': 'Duke Health Technology Solutions, Duke University, Durham, NC, United States of America. Electronic address: deepthi.krishnamaneni@duke.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Corcoran', 'Affiliation': 'Office of Academic Solutions and Information Systems, Duke University, Durham, NC, United States of America. Electronic address: andrew.corcoran@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106163']
3060,33007966,Acute and Chronic Catabolic Responses to  CrossFit ®  and Resistance Training in Young Males .,"Given the wide variety of conditioning program trainings employed, the present study compared the catabolic effects induced by CrossFit ®  and resistance training in moderately trained subjects. Twenty males joined either the CrossFit ®  group (n = 10; 30 min/day of ""workout of the day"") or the resistance training (RT) group (n = 10; 30 min/day of resistance exercises) thrice a week, for 8 weeks. Salivary levels of cortisol, interleukin 1-beta (IL-1β), and uric acid were assessed via enzyme-linked immunosorbent assays before (PRE) and 30-min after (POST) SESSION 1 and SESSION 24. Variables' percentual changes were computed as (POST-PRE)/PRE*100 in each session (Δ%). CrossFit ®  acutely increased cortisol levels in both sessions, with a significant decrease in Δ%cortisol from SESSION 1 to 24. In the RT group, cortisol values decreased in both sessions, only acutely. A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups. While uric acid levels increased in both groups acutely, a chronic downregulation of Δ%uric acid, from SESSION 1 to 24, was appreciated for the RT group only. Overall, CrossFit ®  appeared to induce more intense effects than the RT program as to the investigated catabolic responses.",2020,"A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups.","['moderately trained subjects', 'Twenty males joined either the', 'Young Males ']","['CrossFit ®  and resistance training', 'resistance training (RT', 'CrossFit ®  and Resistance Training', 'CrossFit ®']","['IL-1β levels', 'uric acid levels', 'Salivary levels of cortisol, interleukin 1-beta (IL-1β), and uric acid were assessed via enzyme-linked immunosorbent assays before (PRE', 'cortisol levels', 'cortisol values']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0227177,"A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups.","[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Faelli', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Bisio', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20133 Milano, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Ferrando', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Perasso', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Panascì', 'Affiliation': 'Centro Polifunzionale di Scienze Motorie, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Saverino', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggeri', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17197172']
3061,33007981,"Effects of Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation on Inflammatory Adipokine, Cytokine Concentrations, and Body Composition in Obese Adolescent Boys.","We examined the effects of six weeks of dark chocolate supplementation combined with interval jump rope exercise (JRE) on inflammatory cytokines, adipokines, and body composition in obese adolescent boys. Forty-eight obese adolescent boys (age  = 15.4  ±  1.1 years and body mass index  =  32.2  ±  2.4 kg/m 2 ) were randomly assigned into one of four groups: JRE + white chocolate (JW;  n  = 13), JRE + dark chocolate supplementation (JD;  n  = 13), dark chocolate supplementation (DS;  n  = 12), or control (C;  n  = 12). Participants in JW and JD groups performed JRE for three times per week for six weeks. Participants in the DS and JD groups consumed 30 g of dark chocolate containing 83% of cocoa. Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin)) were evaluated prior to and after the intervention trials. All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations. The improvements in these parameters were greater in the JD group, and additionally, chemerin concentrations decreased only in the JD group. JD enhanced adiponectin concentrations and decreased IL-6 concentrations compared to C. Moreover, JD significantly reduced chemerin concentrations, an effect not observed in any of the other interventions. We demonstrated that dark chocolate supplementation potentiated JRE-induced decreases in body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations in obese adolescent boys. Therefore, JRE combined with dark chocolate supplementation could be a beneficial in reducing obesity-induced inflammation in adolescent boys.",2020,"All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","['obese adolescent boys', 'Forty-eight obese adolescent boys (age\u2009 = 15.4\u2009 ± \u20091.1\u2009years and body mass index\u2009 = \u200932.2\u2009 ± \u20092.4\u2009kg/m 2 ', 'adolescent boys', 'Obese Adolescent Boys']","['dark chocolate containing 83% of cocoa', 'JRE', 'dark chocolate supplementation combined with interval jump rope exercise (JRE', 'JRE combined with dark chocolate supplementation', 'Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation', 'JRE + white chocolate (JW;  n  = 13), JRE + dark chocolate supplementation (JD;  n  = 13), dark chocolate supplementation']","['Inflammatory Adipokine, Cytokine Concentrations, and Body Composition', 'body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations', 'inflammatory cytokines, adipokines, and body composition', 'Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin', 'adiponectin concentrations and decreased IL-6 concentrations', 'obesity-induced inflammation', 'chemerin concentrations', 'body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C3853217', 'cui_str': 'Dark chocolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0453439', 'cui_str': 'White chocolate'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0356434,"All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","[{'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand 9717434765, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran 1961733114, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 81746-73441, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Eskandari', 'Affiliation': 'Qaen school of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand 9717853577, Iran.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, University Hospital of Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}]",Nutrients,['10.3390/nu12103011']
3062,33008106,Hypoxic Pilates Intervention for Obesity: A Randomized Controlled Trial.,"This study examined the effect of Pilates training under hypoxia, a novel treatment method, for obesity. Thirty-two Korean women with obesity (age: 34-60 (47.5 ± 7.5) years) were randomly assigned to control (CON; n = 10), normoxic Pilates training (NPTG; n = 10), and hypoxic Pilates training groups (HPTG; n = 12). The NPTG and HPTG performed 50 min of Pilates training using a tubing band for 12 weeks (3 days/week) in their respective environmental conditions (NPTG: normoxic condition, inspired oxygen fraction (F i O 2 ) = 20.9%; HPTG: moderate hypoxic condition, F i O 2  = 14.5%). The CON maintained their daily lifestyle without intervention. All subjects underwent body composition, blood pressure, arterial stiffness, vascular endothelial function, cardiometabolic biomarker, hemorheological function, and aerobic performance measurements before and after the intervention. The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG. However, compared with the CON and NPTG, the HPTG did not show improvement in other parameters. Hypoxic Pilates intervention is a novel and successful method for promoting endothelial and hemorheological functions in women with obesity.",2020,"The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG.","['Obesity', 'Thirty-two Korean women with obesity (age: 34-60 (47.5 ± 7.5) years', 'women with obesity']","['Hypoxic Pilates intervention', 'Pilates training under hypoxia', 'Hypoxic Pilates Intervention', 'normoxic Pilates training (NPTG; n = 10), and hypoxic Pilates training', 'CON']","['blood pressure, arterial stiffness, vascular endothelial function, cardiometabolic biomarker, hemorheological function, and aerobic performance measurements', 'diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte deformability'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",32.0,0.018354,"The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG.","[{'ForeName': 'Kyounghwa', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197186']
3063,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION


Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS


In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS


Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS


Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
3064,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE


To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA


A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN


A historical cohort.
SETTING


Postoperative period.
PATIENTS


Opioid-naive U.S. veterans.
INTERVENTIONS


The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS


The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS


A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS


Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
3065,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE


In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS


This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS


At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION


This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
3066,33006763,Promoting Active Aging: Lessons Learned in an Implementation Pilot in Primary Care.,"BACKGROUND


Physical activity (PA) preserves mobility, but few practices screen older adults for mobility impairment or counsel on PA.
DESIGN


""Promoting Active Aging"" (PAA) was a mixed-methods randomized-controlled pilot, to test the feasibility and acceptability of a video-based PA counseling tool and implementation into practice of two mobility assessment tools.
SETTING


Three primary care practices affiliated with Wake Forest Baptist Health.
PARTICIPANTS


Adults aged 65 years and older who presented for primary care follow-up and were willing and able to answer self-report questions and walk 4 meters (n = 59).
INTERVENTION


Video-based PA counseling intervention versus control video, ""Healthy Eating.""
MEASUREMENTS


Potential participants completed mobility assessments: self-report (Mobility Assessment Tool-short form (MAT-sf)) and performance based (4-meter walk test). We assessed PAA's implementation-feasibility, acceptability, and value-via interviews and surveys. Effectiveness was measured via participant attendance at a PA information session.
RESULTS


Of 92 patients approached, 89 (96.7%) agreed to mobility assessment. Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test. Sixty-seven (75%) met eligibility criteria, and 59 (88%) consented to be randomized either to the PA counseling intervention (Video-PA) or to active control (Video-C). Most participants viewed the walk test positively (51/59; 86.4%). Staff reported that completion of patient surveys, MAT-sf, and videos required significant staff time and support (median = 26 minutes for all), resulting in low acceptability of MAT-sf and the videos. Attendance at a PA information session did not differ by randomization group (Video-PA = 11/29 (37.9%); Video-C = 12/30 (40%); 95% confidence interval for difference in proportion = -0.29 to 0.25).
CONCLUSIONS


Mobility assessment, particularly a 4-meter walk test, was feasible in primary care. Tablet-based assessment (MAT-sf) and video counseling tools, selected to reduce staff effort, instead required significant time to implement. Future work to promote PA should identify effective ways to facilitate adoption of PA in sedentary older adults that do not burden staff.",2020,"Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test.","['Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test', 'Sixty-seven (75%) met eligibility criteria, and 59 (88%) consented to be randomized either to the', 'sedentary older adults', 'Adults aged 65\u2009years and older who presented for primary care follow-up and were willing and able to answer self-report questions and walk 4 meters (n = 59', 'practices screen older adults for mobility impairment or counsel on PA', 'Three primary care practices affiliated with Wake Forest Baptist Health']","['Video-based PA counseling intervention versus control video, ""Healthy Eating', 'PA counseling intervention (Video-PA) or to active control (Video-C', 'Physical activity (PA']","[""PAA's implementation-feasibility, acceptability, and value-via interviews and surveys"", 'mobility assessments: self-report (Mobility Assessment Tool-short form (MAT-sf)) and performance based (4-meter walk test']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0337728', 'cui_str': 'Baptist Church'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",92.0,0.121303,"Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test.","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Callahan', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Willard', 'Affiliation': 'Center for Healthcare Innovation, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kristie L', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Center for Healthcare Innovation, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Applegate', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Feben', 'Initials': 'F', 'LastName': 'Girma', 'Affiliation': 'Department of General Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Whitehead', 'Affiliation': 'Paris View Family Practice, Bon Secours St. Francis Health System, Greenville, South Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}]",Journal of the American Geriatrics Society,['10.1111/jgs.16838']
3067,33007886,A Low FODMAP Diet Is Nutritionally Adequate and Therapeutically Efficacious in Community Dwelling Older Adults with Chronic Diarrhoea.,"The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP)diet has been extensively researched, but not in the management of older adults with functional gastrointestinal symptoms. This study determines the positive and negative impacts of this dietary treatment in older adults with chronic diarrhea. A non-blinded intervention study was conducted with adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found. Participants followed a dietitian-led low FODMAP diet for six weeks and completed a structured assessment of gastrointestinal symptoms, the Hospital Anxiety and Depression scale, and a four-day food diary before and after the intervention. Twenty participants, mean age 76 years, were recruited. Adherence to the low FODMAP diet was acceptable; mean daily FODMAP intake reduced from 20.82 g to 3.75 g ( p  < 0.001) during the intervention and no clinically significant changes in macro- or micronutrient intakes were observed. There were clinically significant improvements in total gastrointestinal symptoms (pre diet 21.15/88 (standard deviation SD = 10.99), post diet 9.8/88 (SD = 9.58),  p  < 0.001) including diarrhea (pre diet 9.85 (SD = 3.84), post diet 4.05 (SD = 3.86),  p  < 0.001) and significant reductions in anxiety (pre diet 6.11/21 (SD = 4.31), post diet 4.26/21 (SD = 3.38),  p  < 0.05). In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.",2020,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"['older adults with chronic diarrhea', 'Twenty participants, mean age 76 years, were recruited', 'adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found', 'Community Dwelling Older Adults with Chronic Diarrhoea', 'older adults with functional gastrointestinal symptoms']","['Low FODMAP Diet', 'dietitian-led low FODMAP diet']","['diarrhea', 'acceptable; mean daily FODMAP intake', 'total gastrointestinal symptoms', 'macro- or micronutrient intakes', 'anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0861063', 'cui_str': 'Lead low'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0270022,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"[{'ForeName': 'Leigh', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Skidmore', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wall', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University, Melbourne 3004, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gearry', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12103002']
3068,33007909,Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept.,"BACKGROUND


Combining cognitive behavioral therapy (CBT) for psychosis with another psychosocial intervention comprising virtual reality (VR)-assisted therapy (VRT) may improve targeted outcomes in treatment-resistant schizophrenia patients.
METHODS


Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT and were selected at the end of the study as they desired to continue to achieve improvements with VRT (CBT + VRT). Clinical assessments were administered before/after treatments and at follow-ups. Changes in outcomes were examined using linear mixed-effects models. To gain a more in depth understanding on CBT + VRT, therapists' notes, and open interviews on a sub-group of patients were qualitatively analyzed.
RESULTS


Findings showed that the sequence of both interventions was appreciated by all patients. Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life. Although most of these improvements were in similar range to those observed in our comparative trial, effects of CBT + VRT on depressive symptoms and symptoms of schizophrenia were larger than those found for either intervention alone.
CONCLUSION


This proof of concept is the first to merge gold-standard CBT with VRT for treatment refractory voices and to suggest a certain synergistic effect.",2020,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","['Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT', 'Patients with Treatment-Resistant Schizophrenia']","['cognitive behavioral therapy (CBT', 'CBT + VRT', 'virtual reality (VR)-assisted therapy (VRT', 'VRT (CBT + VRT', 'Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy']","['auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life', 'Auditory Hallucinations', 'depressive symptoms and symptoms of schizophrenia']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}]",,0.0124199,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dellazizzo', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Kingsada', 'Initials': 'K', 'LastName': 'Phraxayavong', 'Affiliation': 'Services et Recherches Psychiatriques AD, Montreal, QC, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103169']
3069,33007918,Weight Reduction by the Low-Insulin-Method-A Randomized Controlled Trial.,"Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI,  n  = 15) or waiting list control group (WL,  n  = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (-6.3 kg with (95% confidence interval) (-7.4; -4.5) ( p  < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by -6.7 kg (-9.5; -3.8) ( p  < 0.001) and -6.1 kg (-9.2; -2.7) ( p  < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.",2020,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not.",['individuals with overweight or obesity'],"['low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching', 'starting intervention group (SI,  n  = 15) or waiting list control']","['weight gain', 'weight reduction', 'favour of SI', 'Weight Reduction', 'Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0621233,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Ellinger', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': 'Psychiatric-Psychotherapeutic Day-Care Hospital, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}]",Nutrients,['10.3390/nu12103004']
3070,33015924,"Polypharmacy, functional outcome and treatment effect of intravenous alteplase for acute ischaemic stroke.","BACKGROUND AND PURPOSE


Polypharmacy is an important challenge in clinical practice. Our aim was to determine the effect of polypharmacy on functional outcome and treatment effect of alteplase in acute ischaemic stroke.
METHODS


This was a post hoc analysis of the randomized, placebo-controlled WAKE-UP trial of magnetic resonance imaging guided intravenous alteplase in unknown onset stroke. Polypharmacy was defined as an intake of five or more medications at baseline. Comorbidities were assessed by the Charlson Comorbidity Index (CCI). The primary efficacy variable was favourable outcome defined by a score of 0-1 on the modified Rankin Scale at 90 days. Logistic regression analysis was used to test for an association of polypharmacy with functional outcome, and for interaction of polypharmacy and the effect of thrombolysis.
RESULTS


Polypharmacy was present in 133/503 (26%) patients. Patients with polypharmacy were older (mean age 70 vs. 64 years; p < 0.0001) and had a higher score on the National Institutes of Health Stroke Scale at baseline (median 7 vs. 5; p = 0.0007). A comorbidity load defined by a CCI score ≥ 2 was more frequent in patients with polypharmacy (48% vs. 8%; p < 0.001). Polypharmacy was associated with lower odds of favourable outcome (adjusted odds ratio 0.50, 95% confidence interval 0.30-0.85; p = 0.0099), whilst the CCI score was not. Treatment with alteplase was associated with higher odds of favourable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, p = 0.29).
CONCLUSION


In stroke patients, polypharmacy is associated with worse functional outcome after intravenous thrombolysis independent of comorbidities. However, polypharmacy does not interact with the beneficial effect of alteplase.",2020,"Treatment with alteplase was associated with higher odds of favorable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, P=0.29).
",['acute ischemic stroke'],"['polypharmacy', 'MRI-guided intravenous alteplase', 'placebo', 'alteplase', 'intravenous alteplase']","['CCI score', 'National Institutes of Health Stroke Scale', 'Charlson Comorbidity Index (CCI', 'score of 0-1 on the modified Rankin Scale']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.0952879,"Treatment with alteplase was associated with higher odds of favorable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, P=0.29).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Service de Biostatistique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'T-H', 'Initials': 'TH', 'LastName': 'Cho', 'Affiliation': 'Department of Stroke Medicine, CREATIS CNRS UMR 5220-INSERM U1206, INSA-Lyon, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fiehler', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, University Avenue, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galinovic', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Königsberg', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': ""Department of Radiology, Institut de Diagnostic per la Image (IDI), Institut d'Investigació Biomèdica de Girona (IDIBGI), Hospital Dr Josep Trueta, Parc Hospitalari Martí i Julià de Salt - Edifici M2, Girona, Spain.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Roy', 'Affiliation': 'Service de Biostatistique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Vic., Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, University Avenue, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Department of Stroke Medicine, CREATIS CNRS UMR 5220-INSERM U1206, INSA-Lyon, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pedraza', 'Affiliation': ""Department of Radiology, Institut de Diagnostic per la Image (IDI), Institut d'Investigació Biomèdica de Girona (IDIBGI), Hospital Dr Josep Trueta, Parc Hospitalari Martí i Julià de Salt - Edifici M2, Girona, Spain.""}, {'ForeName': 'C Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",European journal of neurology,['10.1111/ene.14566']
3071,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2020,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
3072,33011482,Combined utility of blood glucose and white blood cell in predicting outcome after acute ischemic stroke: The ENCHANTED trial.,"BACKGROUND


As hyperglycemia and leukocytosis individually predict poor outcome in acute ischemic stroke (AIS), we aimed to determine the significance of their combination on functional outcome and symptomatic intracerebral hemorrhage (sICH) among participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


Post-hoc analyzes of the full ENCHANTED cohort, an international, multicenter, quasi-factorial, randomized, open, blinded outcome-assessed trial of low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment in 4557 thrombolysis-eligible and treated AIS patients. Patients were divided into four groups according to baseline blood glucose and white blood cells (WBC) levels: A (normal glucose + WBC), B (hyperglycemia + normal WBC), C (normal glucose + high WBC), and D (hyperglycemia + high WBC). Logistic regression models were used to determine associations of each group and poor functional outcome (modified Rankin scale scores 2-6) at 90 days and sICH within 48 h, adjusted for confounders. Quality of model fit was examined with Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test.
RESULTS


Of 4181 AIS patients included in analyzes, and with group A as the reference, an increasing odds of poor functional outcome was evident across groups B (odds ratio [OR] 1.38, 95 % confidence interval [CI] 1.17-1.63), C (OR 1.26, 95 %CI 0.99-1.60), and D (OR 2.26, 95 %CI 1.79-2.85) (P trend <0.001). Group D patients also had a higher rate of sICH (P trend <0.05). The model fit with the combination of blood glucose and WBC was better than models of their individual components.
CONCLUSIONS


Using a combination of blood glucose and WBC provides strong prognostic significance than either alone in thrombolyzed AIS patients.",2020,Group D patients also had a higher rate of sICH (P trend <0.05).,"['4557 thrombolysis-eligible and treated AIS patients', 'participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'acute ischemic stroke', '4181 AIS patients', 'acute ischemic stroke (AIS', 'thrombolyzed AIS patients']","['low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment', 'blood glucose and white blood cell']","['rate of sICH', 'baseline blood glucose and white blood cells (WBC) levels: A (normal glucose\u2009+\u2009WBC), B (hyperglycemia\u2009+\u2009normal WBC), C (normal glucose\u2009+\u2009high WBC), and D (hyperglycemia\u2009+\u2009high WBC', 'blood glucose and WBC', 'Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test']","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0885454,Group D patients also had a higher rate of sICH (P trend <0.05).,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; The George Institute China at Peking University Health Science Centre, Beijing, PR China; Heart Health Research Center, Beijing, PR China. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106254']
3073,33011502,"Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.","OBJECTIVE


To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.
STUDY DESIGN


A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.
RESULTS


Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).
CONCLUSION


This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.",2020,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"['Intrauterine fundal anaesthesia during endometrial ablation in the office', 'women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women', '96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial', 'one hospital and one independent treatment center in the Netherlands']","['paracervical anaesthesia with fundal anaesthesia', 'fundal infiltration with saline', 'paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline', 'paracervical anaesthesia without fundal anaesthesia', 'intrauterine fundal anaesthesia', 'fundal anaesthesia combined with paracervical anaesthesia']","['Secondary pain scores', 'co-primary endpoints Faces Pain Score and Numeric Rating Score', 'pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications', 'pain scores, satisfaction, and side-effects', 'non-inferiority margin (2.0 points on changes in pain', 'pain during ablation', 'Faces Pain Score', 'pain']","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",96.0,0.583245,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"[{'ForeName': 'I M A', 'Initials': 'IMA', 'LastName': 'Reinders', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: imke.reinders@maastrichtuniversity.nl.'}, {'ForeName': 'P M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: P.Geomini@mmc.nl.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Leemans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: Jaklien.Leemans@mmc.nl.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Dieleman', 'Affiliation': 'Science Office, Academy, Máxima MC, Veldhoven, the Netherlands. Electronic address: J.Dieleman@mmc.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: a.timmermans@amsterdamumc.nl.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'de Lange', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: m.e.delange@amsterdamumc.nl.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: M.Bongers@mmc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.011']
3074,33018052,Closed-loop Electroencephalogram-based modulated audio to fall and deepen sleep faster.,"The transition from wake to sleep is a continuum that is well characterized by the electroencephalogram (EEG) power spectral ratio (ρ) between the beta (15 to 30 Hz) and theta (4 to 8 Hz) bands. From wake to sleep, the value of ρ gradually decreases.We have designed and implemented a single EEG-signal based closed-loop system that leverages ρ to modulate the volume of a pink-noise type of audio such that the volume becomes gradually softer as sleep initiates. A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.",2020,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,[],['Closed-loop Electroencephalogram-based modulated audio'],['sleep latency and latency to deep sleep'],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.0164796,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': ''}, {'ForeName': 'Boomika', 'Initials': 'B', 'LastName': 'Kalyan', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Aquino', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175689']
3075,33018534,Modulatory Effects of Respiratory-Gated Auricular Vagal Nerve Stimulation on Cardiovagal Activity in Hypertension .,"The objective of this study was to determine potential effects of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on cardiac autonomic activity in hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males) were randomized to receive either active RAVANS at 25 Hz or sham stimulation for 5 consecutive days and were assessed 5 and 10 days later. Continuous electrocardiogram, pulse rate, and blood pressure signals were collected during 10-minute baseline, 30-minute stimulation, and 10-minute recovery periods for each session. LabChart was used to acquire and process heart rate variability and blood pressure indices. Percent changes of mean values during the recovery period were calculated comparing the final stimulation session and follow-up sessions to the first stimulation session. General linear models were applied to assess the effects of RAVANS on the variables evaluated, considering baseline values and sex as covariates in the models.We found that RAVANS increased high frequency (HF-HRV) power during recovery of the final stimulation session and both follow-up sessions in comparison to sham. RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation. No significant effects on blood pressure values were observed during these periods.These results suggest that RAVANS effectively stimulates cardiovagal activity in hypertension, with effects lasting up to 10 days. Future research incorporating larger sample sizes is needed to replicate the effects of RAVANS.Clinical Relevance- This research has implications for potential therapeutic effects of respiratory-gated tVNS on cardiovagal modulation in hypertensive patients.",2020,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"['hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males', 'Hypertension ', 'hypertensive patients']","['Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS', 'Respiratory-Gated Auricular Vagal Nerve Stimulation', 'active RAVANS at 25 Hz or sham stimulation', 'respiratory-gated tVNS', 'RAVANS.Clinical Relevance']","['cardiac autonomic activity', 'heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD', 'Cardiovagal Activity', 'blood pressure values', 'high frequency (HF-HRV', 'Continuous electrocardiogram, pulse rate, and blood pressure signals']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0436104,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Staley', 'Affiliation': ''}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stowell', 'Affiliation': ''}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sclocco', 'Affiliation': ''}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ''}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barbieri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175768']
3076,33021047,"Academic performance of dental students: A randomised trial comparing live, audio recorded and video recorded lectures.","OBJECTIVES


To compare the academic performance of 4th-year dental students randomly divided into three learning groups: live lecture, video recorded lecture and audio recorded lecture. To assess students' attitudes towards the three learning methods.
MATERIALS AND METHODS


4th-year undergraduate students, enrolled in the Orthodontics Theory-1 course, were randomised into three groups receiving different teaching methods; video recorded lecture, audio recorded lecture and live lecture. Subjects were asked to answer two open-ended questions. The first was a simple basic knowledge question in which the answer involved transcribing information from the question, while the second required analytical thinking. Students were also asked to complete a questionnaire assessing their attitudes towards the three learning methods.
RESULTS


94 students participated in the study and were randomly allocated to each learning method. There were no significant differences in scores between the 3 study groups when answering the basic knowledge question (P > .05). The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P < .05). The majority of students agreed that lectures were an essential part of their learning experience and that lectures allowed interaction between students and lecturer. Two-thirds of students reported that watching a video recorded lecture provided a similar learning experience to attending a live lecture.
CONCLUSION


Video recorded, audio recorded and live lectures were found to be equally effective for providing basic knowledge. Video recorded and live lectures were more effective than audio recorded lecture at assessing higher levels of analytical thinking. Students attending video recorded lecture performed as well as those attending the live lecture.",2020,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"['4 th  year undergraduate students, enrolled in the Orthodontics Theory - 1 course', 'dental students', '94 students participated in the study']","['learning groups; live lecture, video recorded lecture, and audio recorded lecture', 'teaching methods; video recorded lecture, audio recorded lecture, and live-lecture']","['mean score for the analytic question', 'academic performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",94.0,0.0222829,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"[{'ForeName': 'Abedalrahman J', 'Initials': 'AJ', 'LastName': 'Shqaidef', 'Affiliation': 'Department of Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Abu-Baker', 'Affiliation': 'University of Jordan, Amman, Jordan.'}, {'ForeName': 'Zaid Bakri', 'Initials': 'ZB', 'LastName': 'Al-Bitar', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Badran', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Hamdan', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12614']
3077,33021115,The effect of Capacitive and Resistive electric transfer on non-specific chronic low back pain.,"The objective of this study was to evaluate the effect of Capacitive and Resistive electric transfer (CRet)-combined exercise therapy for participants with non-specific chronic low back pain (NSCLBP). Twenty-six received only the exercise program (E group, n = 15), or received both CRet and the same exercise program (E+CRet group, n = 11). Pain intensity, functional disability and trunk function were measured pre-, and post-intervention and there was also a 1-month follow-up period. Data analysis was performed for each index using the Mann-Whitney U test for comparisons between two groups at each time point, and the Wilcoxon signed-rank test for comparison between each time point within the group. The results of this study indicate that pain intensity was improved in both groups at post-intervention, also, the effect continued during follow-up period. In addition, functional disability was significantly improved in the E+CRet group at the post-intervention and during the follow-up period. The intervention effect on NSCLBP was higher in the E+CRet group than the E group. CRet, which is a form of deep thermotherapy, combined with exercise have a possibility of more effectiveness than exercise alone.",2020,"Pain intensity, functional disability and trunk function were measured pre-, and post-intervention","['non-specific chronic low back pain', 'participants with non-specific chronic low back pain (NSCLBP']","['Capacitive and Resistive electric transfer (CRet)-combined exercise therapy', 'E+CRet', 'Capacitive and Resistive electric transfer', 'exercise program (E group, n =\xa015), or received both CRet and the same exercise program (E+CRet']","['Pain intensity, functional disability and trunk function', 'functional disability', 'NSCLBP', 'pain intensity']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]",,0.0279466,"Pain intensity, functional disability and trunk function were measured pre-, and post-intervention","[{'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Tashiro', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nakayama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Sonoda', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Mirei', 'Initials': 'M', 'LastName': 'Kawagoe', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Tsuboyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1830795']
3078,33023060,Addition of Probiotics to Anti-Obesity Therapy by Percutaneous Electrical Stimulation of Dermatome T6. A Pilot Study.,"Obesity is becoming a pandemic and percutaneous electrical stimulation (PENS) of dermatome T6 has been demonstrated to reduce stomach motility and appetite, allowing greater weight loss than isolated hypocaloric diets. However, modulation of intestinal microbiota could improve this effect and control cardiovascular risk factors. Our objective was to test whether addition of probiotics could improve weight loss and cardiovascular risk factors in obese subjects after PENS and a hypocaloric diet. A pilot prospective study was performed in patients ( n  = 20) with a body mass index (BMI) > 30 kg/m 2 . Half of them underwent ten weeks of PENS in conjunction with a hypocaloric diet (PENS-Diet), and the other half was treated with a PENS-Diet plus multistrain probiotics ( L. plantarum LP115 ,  B. brevis B3 , and  L. acidophilus LA14 ) administration. Fecal samples were obtained before and after interventions. The weight loss and changes in blood pressure, glycemic and lipid profile, and in gut microbiota were investigated. Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet. Moreover, an enrichment of anti-obesogenic bacteria, including  Bifidobacterium spp, Akkermansia spp, Prevotella spp , and the attenuation of the Firmicutes/Bacteroidetes ratio were noted in fecal samples after probiotics administration. In obese patients, the addition of probiotics to a PENS intervention under a hypocaloric diet could further improve weight loss and glycemic and lipid profile in parallel to the amelioration of gut dysbiosis.",2020,"Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet.","['patients ( n  = 20) with a body mass index (BMI', 'obese subjects after PENS and a hypocaloric diet', 'obese patients']",['probiotics'],"['weight loss', 'glycated hemoglobin and triglycerides', 'weight loss and changes in blood pressure, glycemic and lipid profile, and in gut microbiota', 'weight loss and cardiovascular risk factors', 'weight loss and glycemic and lipid profile', 'Weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0225008,"Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet.","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Lorenzo', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Crespo-Yanguas', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Hang', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Jairo', 'Initials': 'J', 'LastName': 'Lumpuy-Castillo', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Artur M', 'Initials': 'AM', 'LastName': 'Hernández', 'Affiliation': 'Department of Sport Sciences, Universidad Europea de Madrid, 28670 Villaviciosa de Odón-Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Llavero', 'Affiliation': 'Obesity Unit, Clinica Garcilaso, 28010 Madrid, Spain.'}, {'ForeName': 'MLuisa', 'Initials': 'M', 'LastName': 'García-Alonso', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Obesity Unit, Clinica Garcilaso, 28010 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17197239']
3079,33023067,Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial.,"Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.",2020,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60).","['Indian pregnant women', 'supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg', 'Offspring Neurodevelopment at 12 Months in India', '3379 women screened, 1131 were found eligible; 957 were randomized']","['Maternal Docosahexaenoic Acid (DHA) Supplementation', 'd algal DHA', 'placebo', 'Maternal supplementation', 'dietary docosahexaenoic acid (DHA 22:6n-3']","['mean development quotient (DQ) scores', 'infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]",9.0,0.541987,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60).","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Metgud', 'Affiliation': ""KAHER's Institute of Physiotherapy, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Jogalekar', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kamate', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, C-1/52, Block C 1, Bhim Nagri, Hauz Khas, New Delhi 110016, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi 110029, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}]",Nutrients,['10.3390/nu12103041']
3080,33023132,Dietary Quality Changes According to the Preceding Maximum Weight: A Longitudinal Analysis in the PREDIMED-Plus Randomized Trial.,"One-year dietary quality change according to the preceding maximum weight in a lifestyle intervention program (PREDIMED-Plus trial, 55-75-year-old overweight or obese adults;  n  = 5695) was assessed. A validated food frequency questionnaire was used to assess dietary intake. A total of 3 groups were made according to the difference between baseline measured weight and lifetime maximum reported weight: (a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM. Data were analyzed by General Linear Model. All participants improved average lifestyle. Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns. People at maximum weight are the most benefitted in the short term by a weight management program. Long term weight loss efforts may also reduce the effect of a weight management program.",2020,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","['55-75-year-old overweight or obese adults;  n  = 5695', 'a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM']",[],"['weight and lifetime maximum reported weight', 'dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns', 'average lifestyle', 'Dietary Quality Changes']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0275905,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bouzas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Bibiloni', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mateos', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Mèdica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL-UMH, Miguel Hernández University, 46020 Alicante, Spain.'}, {'ForeName': 'Rafael M', 'Initials': 'RM', 'LastName': 'Micó-Pérez', 'Affiliation': 'Fundación Semergen, 28009 Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ortíz-Ramos', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Altés-Boronat', 'Affiliation': 'Department of Endocrinology, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain.'}, {'ForeName': 'Bogdana L', 'Initials': 'BL', 'LastName': 'Luca', 'Affiliation': 'Department of Endocrinology, Fundación Jiménez-Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sayon-Orea', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ignacio Manuel', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tojal-Sierra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernabé-Casanova', 'Affiliation': 'Centro Salud Raval, 03203 Elche-Alicante, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Martin-Padillo', 'Affiliation': 'Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Castro-Barquero', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Cesar I', 'Initials': 'CI', 'LastName': 'Fernandez-Lazaro', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Hernández-Alonso', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saiz', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Belló-Mora', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Basterra-Gortari', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}]",Nutrients,['10.3390/nu12103023']
3081,33023221,"Effect of Increasing the Dietary Protein Content of Breakfast on Subjective Appetite, Short-Term Food Intake and Diet-Induced Thermogenesis in Children.","Dietary protein affects energy balance by decreasing food intake (FI) and increasing energy expenditure through diet-induced thermogenesis (DIT) in adults. Our objective was to investigate the effects of increasing the dietary protein in an isocaloric breakfast on subjective appetite, FI, blood glucose, and DIT in 9-14 y children. Two randomized repeated measures designs were used. In experiment 1, 17 children (9 boys, 8 girls) consumed isocaloric meals (450 kcal) on four separate mornings containing: 7 g (control), 15 g (low protein, LP), 30 g (medium protein, MP) or 45 g (high protein, HP) of protein. Blood glucose and subjective appetite were measured at baseline and regular intervals for 4 h, and FI was measured at 4 h. In experiment 2, 9 children (6 boys, 3 girls) consumed the control or HP breakfast on two separate mornings, and both DIT and subjective appetite were determined over 5 h. In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05). In experiment 2, DIT was higher after HP than control ( p  < 0.05). In conclusion, increasing the dietary protein content of breakfast had favorable effects on satiety, FI, and DIT in children.",2020,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05).","['adults', '9 children (6 boys, 3 girls', '9-14', '17 children (9 boys, 8 girls', 'Children', 'y children']","['control or HP breakfast', 'Dietary Protein Content of Breakfast', 'consumed isocaloric meals']","['satiety, FI, and DIT', 'HP breakfast suppressed FI', 'subjective appetite, FI, blood glucose, and DIT', 'Blood glucose and subjective appetite', 'subjective appetite', 'DIT and subjective appetite']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0125685,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05).","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Fansabedian', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Vincent C H', 'Initials': 'VCH', 'LastName': 'Wong', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S-0A2, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schwartz', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Suitor', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry & Biology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}]",Nutrients,['10.3390/nu12103025']
3082,33031670,Is a Trial of Perioperative Cognitive Training to Prevent Early Postoperative Cognitive Decline Actually Feasible?,,2020,,[],['Perioperative Cognitive Training'],['Early Postoperative Cognitive Decline'],[],"[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",,0.0276795,,"[{'ForeName': 'Hilary P', 'Initials': 'HP', 'LastName': 'Grocott', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, hgrocott@sbgh.mb.ca Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephan K W', 'Initials': 'SKW', 'LastName': 'Schwarz', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004859']
3083,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
3084,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
3085,31453722,"The Association between Prehospital Vulnerability, ARDS Development, and Mortality among At-Risk Adults. Results from the LIPS-A Clinical Trial.","Rationale:  No previous studies have examined the role of prehospital vulnerability in acute respiratory distress syndrome (ARDS) development and mortality in an acutely ill adult population. Objectives:  To describe the association between prehospital vulnerability and  1 ) the development of ARDS,  2 ) 28-day mortality, and  3 ) 1-year mortality. Methods:  This was a longitudinal prospective cohort study nested within the multicenter LIPS-A (Lung Injury Prevention Study-Aspirin) trial. We analyzed 301 participants who completed Vulnerable Elders Survey (VES) at baseline. Multivariable logistic regression and Cox regression analyses were used to describe the association between vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality), respectively. Results:  The VES score ranged from 0 to 10 (median [interquartile range], 2.0 [0-6]); 143 (47.5%) fit criteria for prehospital vulnerability (VES ≥ 3). Vulnerability was not significantly associated with ARDS development (10 [7.0%] vulnerable patients developed ARDS as per LIPS-A study criteria vs. 20 [12.7%] without vulnerability;  P  = 0.10; adjusted odds ratio [95% confidence interval (CI)], 0.54 [0.24-1.24];  P  = 0.15). Nor was vulnerability associated with 28-day mortality (15 [10.5%] vulnerable patients were dead by Day 28 vs. 11 [7.0%] nonvulnerable patients;  P  = 0.28; adjusted odds ratio [95% CI], 0.95 [0.39-2.26];  P  = 0.90). Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02). Conclusions:  In a population of adults recruited for their high risk of ARDS, prehospital vulnerability, measured by VES, was highly prevalent and strongly associated with 1-year mortality.",2019,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02).","['acutely ill adult population', '301 participants who completed Vulnerable Elders Survey (VES) at baseline']",[],"['ARDS development', 'Vulnerability', 'vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality', '1-year mortality', '28-day mortality', 'VES score', 'Prehospital Vulnerability, ARDS Development, and Mortality', 'ARDS,  2 ) 28-day mortality, and  3 ) 1-year mortality', '1-year mortality in hospital survivors']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",301.0,0.201061,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02).","[{'ForeName': 'Aluko A', 'Initials': 'AA', 'LastName': 'Hope', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jen-Ting', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Department of Anesthesiology and.'}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201902-116OC']
3086,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND


Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE


To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN


and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES


The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS


During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS


Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
3087,33011649,The Unified Protocol compared with diagnosis-specific protocols for anxiety disorders: 12-month follow-up from a randomized clinical trial.,"OBJECTIVE


To examine whether the Unified Protocol (UP) remains equivalent to single-disorder protocols (SDPs) in the treatment of anxiety disorders at 12-month follow-up.
METHOD


We report results from the 12-month follow-up of a recent randomized equivalence trial [1]. Data are from 179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder and were randomized to either the UP or SDP conditions. Consistent with the parent trial, the primary outcome was principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS). Secondary outcomes included anxiety, depression, and impairment. Missing data were accommodated using multiple imputation (10,000 imputed data sets) under a missing at random assumption. Equivalence between the UP and SDPs was tested using slope difference scores from latent growth models and 95% confidence interval of between-condition effect sizes.
RESULTS


The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up. In addition, there were no significant differences between conditions on secondary outcomes at 12-month follow-up.
CONCLUSIONS


The UP continues to yield outcomes comparable to SDPs at 12-month follow-up, and therefore provides a single intervention that can be used to treat the most commonly occurring psychiatric disorders with durable effects.",2020,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"['179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder']",['diagnosis-specific protocols'],"['anxiety, depression, and impairment', 'principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS', 'principal diagnosis clinician severity rating']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",,0.0824821,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"[{'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Eustis', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America. Electronic address: eeustis@bu.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, The University of Houston, Health and Biomedical Sciences Building, 4849 Calhoun Rd - Room 373, Houston, TX 77204, United States of America.'}, {'ForeName': 'Julianne W', 'Initials': 'JW', 'LastName': 'Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.012']
3088,33011864,24-Hour Serial Spirometric Assessment of Once-Daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-Daily Budesonide/Formoterol in Patients with COPD: Analysis of the FULFIL Study.,"INTRODUCTION


Few studies have utilized 24-h serial spirometry to compare the effects of inhaled chronic obstructive pulmonary disease (COPD) therapies on lung function. The FULFIL study previously reported significant lung function improvements with once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR) in patients with symptomatic COPD at risk of exacerbations.
METHODS


This prespecified analysis evaluated 24-h serial spirometry data from a subgroup of 406 patients in FULFIL. BUD/FOR twice-daily dosing was maintained during 24-h spirometry. A post hoc analysis evaluated serial forced expiratory volume in 1 s (FEV 1 ) at day 1 and week 24 by disease severity at screening (FEV 1  < 50% predicted and no moderate or severe exacerbation in prior year, FEV 1  < 50% predicted and ≥ 1 moderate or severe exacerbation in prior year, and FEV 1  ≥ 50% and < 80% predicted and ≥ 2 moderate or ≥ 1 severe exacerbations in prior year).
RESULTS


Odds of achieving a ≥ 100-mL increase from baseline in FEV 1  within the first 6 h post dose on day 1 were significantly greater with FF/UMEC/VI than BUD/FOR [odds ratio 2.79 (95% confidence interval 1.56-4.98); p < 0.001]. FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL; all p < 0.001). Significant between-treatment differences in FEV 1  and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR were seen at all time points at week 24 (FEV 1  range 156-231 mL, all p < 0.001; FVC range 139-309 mL, all p ≤ 0.002). Serial FEV 1  results were consistent irrespective of disease severity at screening.
CONCLUSION


These findings further demonstrate sustained lung function benefits with once-daily FF/UMEC/VI single-inhaler triple therapy in patients with symptomatic COPD at risk of exacerbations across a range of disease severities.",2020,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","['Patients with COPD', '406 patients in FULFIL', 'patients with symptomatic COPD at risk of exacerbations across a range of disease severities', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR', 'Fluticasone Furoate/Umeclidinium/Vilanterol', 'Budesonide/Formoterol']","['serial forced expiratory volume', 'FEV 1  and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR', '24-Hour Serial Spirometric Assessment', 'severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",406.0,0.336625,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, 1250 S Collegeville Rd, Collegeville, PA, 19426, USA. david.a.lipson@gsk.com.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Birk', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Brealey', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}]",Advances in therapy,['10.1007/s12325-020-01496-7']
3089,33012603,Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial.,"Data on influenza vaccine immunogenicity in children are limited from tropical developing countries. We recently reported significant, moderate effectiveness of a trivalent inactivated influenza vaccine (IIV) in a controlled, cluster-randomized trial in children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906). We report immunogenicity of IIV3 and inactivated polio vaccine (IPV) from that trial. We evaluated hemagglutination inhibition (HAI) and polio antibody titers in response to vaccination of three age groups (6 through 35 months, 3 through 5 years, and 6 through 8 years). As all children were IIV naïve, each received two vaccine doses, although titers were assessed after only the first dose for subjects aged 6 through 8 years. Seroconversion rates (4-fold titer rise or increase from <1:10 to ≥1:40) were 74-87% for A/H1N1, 76-87% for A/H3N2, and 54-79% for B/Yamagata. Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata. IIV responses were lowest in the youngest age group, and they were comparable between ages 3 through 5 years after two doses and 6 through 8 years after one dose. We found that baseline seropositivity (HAI titer ≥ 1:10) was an effect modifier of IIV response. Using a seroprotective titer (HAI titer ≥ 1:160) recommended for IIV evaluation in children, we found that among subjects who were seropositive at baseline, 69% achieved seroprotection for both A/H1N1 and A/H3N2, while among those who were seronegative at baseline, seroprotection was achieved in 11% for A/H1N1 and 22% for A/H3N2. The IPV group had high baseline polio antibody seropositivity and appropriate responses to vaccination. Our data emphasize the importance of a two-dose IIV3 series in vaccine naïve children. IIV and IPV vaccines were immunogenic in Senegalese children.",2020,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","['children are limited from tropical developing countries', 'children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906', 'Senegalese children', 'vaccine naïve children', 'three age groups (6 through 35\xa0months, 3 through 5\xa0years, and 6 through 8\xa0years', 'children in Senegal']","['IIV3 and inactivated polio vaccine (IPV', 'trivalent inactivated influenza vaccine (IIV', 'seasonal inactivated influenza and inactivated polio vaccines']","['Seroprotection rates', 'hemagglutination inhibition (HAI) and polio antibody titers', 'Seroconversion rates', 'IIV responses', 'seroprotection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337846', 'cui_str': 'Senegalese'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",,0.0885076,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","[{'ForeName': 'Mbayame', 'Initials': 'M', 'LastName': 'Niang', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Deming', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA; Institute of Human Virology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ndongo', 'Initials': 'N', 'LastName': 'Dia', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'PATH, Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium; Division Global Health Protection, Centers for Disease Control and Prevention, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.059']
3090,33019104,Development and Validation of a Predictive Model for Hemodynamic Responses to Resuscitation during Uncontrolled Hemorrhage .,"We investigated whether a statistical model could predict mean arterial pressure (MAP) during uncontrolled hemorrhage; such a model could be used for automated decision support, to help clinicians decide when to provide intravascular volume to achieve MAP goals. This was a secondary analysis of adult swine subjects during uncontrolled splenic bleeding. By protocol, after developing severe hypotension (MAP < 60 mmHg), subjects were resuscitated with either saline (NS) or fresh frozen plasma (FFP), determined randomly. Vital signs were documented at quasi-regular time-step intervals, until either subject death or 300 min. Subjects were randomly separated 50%/50% into training/validation sets, and regression models were developed to predict MAP for each subsequent (i.e., future) time-step. Median time-steps for serially recorded vital signs were +15 min. 5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134). The final model consisted of: current MAP; heart rate (HR); prior NS; imminent NS; and imminent FFP. The 95% limits-of-agreement between true subsequent MAP vs. predicted subsequent MAP were +10/-11 mmHg for the 79 time-steps in the training set; and +14/-13 for the 64 time-steps in the validation set. A total of 10 sudden death events (i.e., rapid, fatal MAP decrease within one single time-step) were excluded from analysis. In conclusion, for uncontrolled hemorrhage in a swine model, it was possible to estimate the next documented MAP value on the basis of the subject's current documented MAP; HR; prior NS; and the volume of resuscitation about to be administered. However, the model was unable to predict ""sudden death"" events. The applicability to populations with wider heterogeneity of hemorrhage patterns and with comorbidities requires further investigation.",2020,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,['adult swine subjects during uncontrolled splenic bleeding'],['saline (NS) or fresh frozen plasma (FFP'],"['Median time-steps', 'mean arterial pressure (MAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0520745', 'cui_str': 'Splenic hemorrhage'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.0222451,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,"[{'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Reisner', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Dubick', 'Affiliation': ''}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Reisner', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176141']
3091,33019602,The Influence of Thermal Alterations on Prefrontal Cortex Activation and Neuromuscular Function during a Fatiguing Task.,"The purpose of this study was to examine prefrontal cortex (PFC) activation, neuromuscular function, and perceptual measures in response to a fatiguing task, following thermal alterations of an exercising arm. Nineteen healthy adults completed three experimental sessions. At baseline, participants performed maximum voluntary isometric contractions (MVIC) of the elbow flexors. Next, participants submerged their right arm in a water bath for 15 min. Cold (C), neutral (N), and hot (H) water temperatures were maintained at 8, 33, and 44 °C, respectively. Following water immersion, participants performed an isometric elbow flexion contraction, at 20% of their MVIC, for 5 min. Ratings of perceived exertion (RPE), muscular discomfort, and task demands were assessed. Functional near-infrared spectroscopy was used to measure activation (oxygenation) of the PFC during the fatiguing task. Reductions in MVIC torque at the end of the fatiguing task were greater for the H (25.7 ± 8.4%) and N (22.2 ± 9.6%) conditions, compared to the C condition (17.5 ± 8.9%,  p  < 0.05). The increase in oxygenation of the PFC was greater for the H (13.3 ± 4.9 μmol/L) and N (12.4 ± 4.4 μmol/L) conditions, compared to the C condition (10.3 ± 3.8 μmol/L,  p  < 0.001) at the end of the fatiguing task. The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01). These results indicate that precooling an exercising arm attenuates the rise in PFC activation, muscle fatigue, and psychological rating during a fatiguing task.",2020,"The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01).",['Nineteen healthy adults'],[],"['maximum voluntary isometric contractions (MVIC) of the elbow flexors', 'RPE, muscular discomfort, and task demands', 'oxygenation of the PFC', 'PFC activation, muscle fatigue, and psychological rating', 'Prefrontal Cortex Activation and Neuromuscular Function', 'prefrontal cortex (PFC) activation, neuromuscular function, and perceptual measures', 'MVIC torque', 'Cold (C), neutral (N), and hot (H) water temperatures', 'Ratings of perceived exertion (RPE), muscular discomfort, and task demands']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0337023', 'cui_str': 'Hot water'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",,0.0211816,"The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01).","[{'ForeName': 'Kevin Cyle', 'Initials': 'KC', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Verbrigghe', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gabe', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Jauquet', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Eischer', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Tejin', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Physical Education, Kangwon National University, 1 Gangwondaehak-gil, Hyoja-dong, Chuncheon-si, Gangwon-do 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197194']
3092,33019646,"Synergistic Effects of Regular Walking and Alkaline Electrolyzed Water on Decreasing Inflammation and Oxidative Stress, and Increasing Quality of Life in Individuals with Type 2 Diabetes: A Community Based Randomized Controlled Trial.","Alkaline electrolyzed water (AEW) and walking are strongly recommended for ameliorating oxidative stress and inflammation. Nevertheless, there is a lack of information on the combination of both on alleviating inflammation, oxidative stress, and improving the quality of life (QoL). We investigated the synergistic effects of drinking AEW and walking on advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL. In total, 81 eligible patients with type 2 diabetes (T2DM) were randomly allocated via single blind to four groups: consumed 2 L/day of AEW ( n  = 20), instructed to walk for 150 min/week ( n  = 20), received a combination of AEW and walking ( n  = 20), and continue their habitual diet and activity ( n  = 21). Data were collected and analyzed before and after 8 weeks of intervention. Our results showed a significant interaction between the group and time, with both AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels. Moreover, the AEW group had a higher physical and total QoL score. The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group. The synergistic effect of AEW and regular walking are an advisable treatment for patients with T2DM.",2020,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","['81 eligible patients with type 2 diabetes (T2DM', 'Individuals with Type 2 Diabetes', 'patients with T2DM']","['AEW and regular walking', 'combination of AEW and walking ( n  = 20), and continue their habitual diet and activity', 'Alkaline electrolyzed water (AEW', 'Regular Walking and Alkaline Electrolyzed Water']","['higher scores in physical, mental and total QoL', 'AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels', 'Inflammation and Oxidative Stress, and Increasing Quality of Life', 'advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL', 'quality of life (QoL', 'higher physical and total QoL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",81.0,0.0258548,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","[{'ForeName': 'Yohanes Andy', 'Initials': 'YA', 'LastName': 'Rias', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}, {'ForeName': 'Adi Lukas', 'Initials': 'AL', 'LastName': 'Kurniawan', 'Affiliation': 'Research Center for Healthcare Industry Innovation, National Taipei University of Nursing and Health Sciences, 365 Ming-te Road, Beitou District, Taipei 112, Taiwan.'}, {'ForeName': 'Ching Wen', 'Initials': 'CW', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taipei 11031, Taiwan.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Camperdown 2050, Australia.'}, {'ForeName': 'Hsiu Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100946']
3093,33020394,Acute Photobiomodulation Does Not Influence Specific High-Intensity and Intermittent Performance in Female Futsal Players.,"The acute improvement of performance after photobiomodulation therapy (PBMT) has been reported in different types of exercise. However, the effect on high-intensity and intermittent exercises that are relevant for team sports is unknown. Thus, we evaluated the effect of prior acute application of PBMT on high-intensity and intermittent exercise performance, muscle oxygenation, and physiological/perceptual indicators in amateur female futsal players. Thirteen players (24.1 ± 3.7 years) performed a testing battery (countermovement jump (CMJ), Illinois agility and YoYo intermittent recovery test level 1 (YYIR1)) preceded by 15 min of PBMT (1 min 30 s each muscular point; five muscular points in each lower limbs) or 15 min of placebo (SHAM), in a counterbalanced randomized cross-over design (one-week in-between PBMT/SHAM). All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses. The acute application of PBMT prior to a physical testing battery does not influence high-intensity and intermittent exercises performance, neither physiological nor perceptual responses in amateur female futsal players.",2020,"All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses.","['Thirteen players (24.1 ± 3.7 years) performed a', 'Female Futsal Players', 'amateur female futsal players']","['photobiomodulation therapy (PBMT', 'testing battery (countermovement jump (CMJ), Illinois agility and YoYo intermittent recovery test level 1 (YYIR1)) preceded by 15 min of PBMT (1 min 30 s each muscular point; five muscular points in each lower limbs) or 15 min of placebo (SHAM', 'PBMT']","['high-intensity and intermittent exercise performance, muscle oxygenation, and physiological/perceptual indicators', 'blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0246837', 'cui_str': ""1,1'-((4,4,7,7-tetramethyl)-4,7-diazaundecamethylene)bis-4-(3-methyl-2,3-dihydro(benzo-1,3-oxazole)-2-methylidine)quinolinium, tetraiodide""}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",,0.145645,"All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses.","[{'ForeName': 'Izabela Aparecida Dos', 'Initials': 'IAD', 'LastName': 'Santos', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Marina de Paiva', 'Initials': 'MP', 'LastName': 'Lemos', 'Affiliation': 'Exercise Physiology in Health and Human Performance Research Group, Department of Physical Education, University of Uberaba (UNIUBE), Uberaba 38055-500, Brazil.'}, {'ForeName': 'Vitória Helena Maciel', 'Initials': 'VHM', 'LastName': 'Coelho', 'Affiliation': 'Department of Physiotherapy, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Department of Physical Education, Laboratory of Physiology and Sport Performance (LAFIDE), School of Sciences, Sao Paulo State University (UNESP), Bauru 17033-360, Brazil.'}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Marocolo', 'Affiliation': 'Physiology and Human Performance Research Group, Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora 360360-900, Brazil.'}, {'ForeName': 'Rogério Nogueira', 'Initials': 'RN', 'LastName': 'Soares', 'Affiliation': 'Dalton Cardiovascular Research Center, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Octávio', 'Initials': 'O', 'LastName': 'Barbosa Neto', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Gustavo R', 'Initials': 'GR', 'LastName': 'Mota', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17197253']
3094,33020411,Effect of a Single Session of Intermittent Hypoxia on Erythropoietin and Oxygen-Carrying Capacity.,"Intermittent hypoxia, defined as alternating bouts of breathing hypoxic and normoxic air, has the potential to improve oxygen-carrying capacity through an erythropoietin-mediated increase in hemoglobin mass. The purpose of this study was to determine the effect of a single session of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young healthy individuals. Nineteen participants were randomly assigned to an intermittent hypoxia group (Hyp,  n  = 10) or an intermittent normoxia group (Norm,  n  = 9). Intermittent hypoxia consisted of five 4-min hypoxic cycles at a targeted arterial oxygen saturation of 90% interspersed with 4-min normoxic cycles. Erythropoietin levels were measured before and two hours following completion of the protocol. Hemoglobin mass was assessed the day before and seven days after exposure to intermittent hypoxia or normoxia. As expected, the intermittent hypoxia group had a lower arterial oxygen saturation than the intermittent normoxia group during the intervention (Hyp: 89 ± 1 vs. Norm: 99 ± 1%,  p  < 0.01). Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15). Hemoglobin mass did not change following exposure to intermittent hypoxia. This single session of intermittent hypoxia was not sufficient to elicit a significant rise in erythropoietin levels or hemoglobin mass in young healthy individuals.",2020,"Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15).","['young healthy individuals', 'Nineteen participants']","['Erythropoietin and Oxygen-Carrying Capacity', 'intermittent hypoxia group (Hyp,  n  = 10) or an intermittent normoxia group']","['Hemoglobin mass', 'erythropoietin levels and hemoglobin mass', 'erythropoietin levels or hemoglobin mass', 'Erythropoietin levels', 'arterial oxygen saturation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}]",19.0,0.0236488,"Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15).","[{'ForeName': 'Mercedes J', 'Initials': 'MJ', 'LastName': 'Nagel', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}, {'ForeName': 'Caitlin P', 'Initials': 'CP', 'LastName': 'Jarrard', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lalande', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17197257']
3095,33020447,"Effectiveness of ""Hand Hygiene Fun Month"" for Kindergarten Children: A Pilot Quasi-Experimental Study.","Early childhood is a formative period during which healthy habits are developed, including proper hand hygiene practices. The aim of this quasi-experimental study was to determine the effectiveness of a 4-week series of educational sessions that consider the cognitive developmental stage of children on increasing their knowledge and promoting hand hygiene practices. The intervention group ( n  = 33) observed the hand hygiene program, whereas another group served as the waitlist control ( n  = 20). Creative activities were planned for the illustration of hand hygiene concepts in terms of ""right moments"", ""right steps"", and ""right duration"". Hand sanitizer coverage was evaluated using a hand scanner. After the intervention, the experimental group had higher knowledge level toward hand hygiene than the control group ( p  < 0.001). Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group. The study demonstrated that the knowledge and proper hand hygiene (HH) practice of children can be positively influenced by the use of an age-appropriate education program. The results of this study have implications for school health educators and parents for promoting HH practices among children at home and at the school level.",2020,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group.","['Kindergarten Children', 'school health educators and parents for promoting HH practices among children at home and at the school level']","['educational sessions', 'Hand Hygiene Fun Month', 'hand hygiene program, whereas another group served as the waitlist control']","['hand hygiene performance', 'overall hand coverage', 'knowledge level toward hand hygiene']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708552', 'cui_str': 'School health educator'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",,0.0163116,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group.","[{'ForeName': 'Lorna Kwai Ping', 'Initials': 'LKP', 'LastName': 'Suen', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Janet Pui Lee', 'Initials': 'JPL', 'LastName': 'Cheung', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}]",International journal of environmental research and public health,['10.3390/ijerph17197264']
3096,33021484,Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial.,"BACKGROUND


African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols.
OBJECTIVE


This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs.
METHODS


A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894).
RESULTS


At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
CONCLUSIONS


These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints.",2020,"The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
","['African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs', '64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs', 'Prehypertensive Adults']","['breathing awareness meditation (BAM', 'Smartphone Meditation App']","['sleep fragmentation', 'longer sleep duration', 'Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring', 'lower fragmentation, longer sleep duration, and higher efficiency', 'sleep efficiency and quality as well as the PSQI global value', 'sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep', 'average sleep', 'Sleep quality']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",64.0,0.0328084,"The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Sieverdes', 'Affiliation': 'College of Charleston, Health and Human Performance, Charleston, SC, United States.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Treiber', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kline', 'Affiliation': 'Department of Health & Physical Activity, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Brunner-Jackson', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sox', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Cain', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Swem', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}]",JMIR formative research,['10.2196/20501']
3097,33021488,Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial.,"BACKGROUND


Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.
OBJECTIVE


Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.
METHODS


A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.
RESULTS


A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.
CONCLUSIONS


The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.",2020,"The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
","['556 adult smokers (aged 18\u2009years or older) smoking at least 5 cigarettes a day for the past year were recruited', 'Adult Smokers', '530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit', 'n=277; control', '556 participants were randomized (treatment', 'Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom']","['smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities', 'Digital Therapeutic Intervention', 'carbon monoxide device', 'nicotine replacement therapy', 'digital therapeutic intervention', 'carbon monoxide measurement (carbon monoxide <10 ppm']","['self-reported 7-day point prevalence abstinence at 4 weeks post quit date', 'carbon monoxide readings']","[{'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement'}, {'cui': 'C0439187', 'cui_str': 'ppm'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",556.0,0.371296,"The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Webb', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sarrah', 'Initials': 'S', 'LastName': 'Peerbux', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smittenaar', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sarim', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Sherwani', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Maroof', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'MacRae', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Puri', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sangita', 'Initials': 'S', 'LastName': 'Bhalla', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Majeed', 'Affiliation': 'Imperial College London, London, United Kingdom.'}]",JMIR mental health,['10.2196/22833']
3098,33021490,"BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments.","BACKGROUND


Information and communication technology may provide domiciliary care programs with continuity of care. However, evidence about the effectiveness and cost-effectiveness of information and communication technology in the context of integrated care models is relatively scarce.
OBJECTIVE


The objective of our study was to provide evidence on the clinical effectiveness and cost-effectiveness of the BeyondSilos project for patients enrolled in the Badalona city pilot site in Spain.
METHODS


A quasi-experimental study was used to assess the cost-effectiveness of information and communication technology-enhanced integration of health and social care, including the third sector (intervention), compared to basic health and social care coordination (comparator). The study was conducted in Badalona between 2015 and 2016. Participants were followed for 8 months.
RESULTS


The study included 198 patients: 98 in the intervention group and 100 in the comparator group. The mean Barthel index remained unchanged in the intervention group (mean change 0.14, 95% CI -4.51 to 4.78; P=.95) but decreased in the comparator group (mean change -3.23, 95% CI -5.34 to -1.11; P=.003). Instrumental Activities of Daily Living significantly decreased in both groups: mean changes of -0.23 (95% CI -0.44 to -0.02; P=.03) and -0.33 (95% CI -0.46 to -0.20; P<.001) in the intervention and comparator groups, respectively. No differences were found in the Geriatric Depression Scale (intervention: mean change 0.28, 95% CI -0.44 to 1.01, P=.44; comparator: mean change -0.29, 95% CI -0.59 to 0.01, P=.06). The intervention showed cost-effectiveness (incremental cost-effectiveness ratio €6505.52, approximately US $7582).
CONCLUSIONS


The information and communication technology-enhanced integrated domiciliary care program was cost-effective. The beneficial effects of this approach strongly rely upon the commitment of the professional staff involved.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03111004; http://clinicaltrials.gov/ct2/show/ NCT03111004.",2020,Instrumental Activities of Daily Living significantly decreased in both groups:,"['patients enrolled in the Badalona city pilot site in Spain', 'Badalona between 2015 and 2016', '198 patients: 98 in the intervention group and 100 in the comparator group', 'Older Patients']","['information and communication technology-enhanced integration of health and social care, including the third sector (intervention), compared to basic health and social care coordination (comparator', 'Telehealth-Enhanced Integrated Care Model']","['Geriatric Depression Scale (intervention', 'clinical effectiveness and cost-effectiveness', 'cost-effectiveness (incremental cost-effectiveness ratio €', 'Instrumental Activities of Daily Living', 'mean Barthel index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",198.0,0.0587592,Instrumental Activities of Daily Living significantly decreased in both groups:,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jiménez', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Daugbjerg', 'Affiliation': 'Graduate School of Health Economics and Management, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Stafylas', 'Affiliation': 'Medical Research & Innovation (HEALTHINK), Thessaloniki, Greece.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'PMV Research Group, Universität zu Köln, Köln, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Empirica Gesellschaft für Kommunikations und Technologieforschung GmbH, Bonn, Germany.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lewis', 'Affiliation': 'International Foundation for Integrated Care, Oxford, United Kingdom.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'da Col', 'Affiliation': 'IGEA Hospital Trieste, Trieste, Italy.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiáñez-Villanueva', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",JMIR medical informatics,['10.2196/20938']
3099,33022957,Short-Term Effects of Salt Restriction via Home Dishes Do Not Persist in the Long Term: A Randomized Control Study.,"Salt intake reduction is crucial to prevent non-communicable diseases (NCDs) globally. This study aimed to investigate the short- and long-term effects of monitoring salt concentration in homemade dishes on reducing salt intake in a Japanese population. A double-blind randomized controlled trial using a 2 × 2 factorial design with two interventions was conducted in 195 participants; they were assigned to both interventions for a group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning). We evaluated 24-hour urinary sodium excretions at baseline and after a three-month intervention for the changes as major outcomes, at six- and twelve-months after baseline as long-term follow-up surveys. Urinary sodium excretion decreased in both intervention and control groups after the intervention. However, differences in the change for both monitoring and low-sodium seasoning interventions were statistically non-significant ( p  = 0.29 and 0.52, respectively). Urinary sodium excretion returned to the baseline level after twelve-months for all groups. Monitoring of salt concentration is ineffective in reducing salt intake for short- and long-term among the people studied in this cohort.",2020,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"['195 participants', 'a Japanese population']","['group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning', 'Salt Restriction via Home Dishes']","['24-hour urinary sodium excretions', 'Urinary sodium excretion', 'salt intake']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",195.0,0.0944828,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Maruya', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Ribeka', 'Initials': 'R', 'LastName': 'Takachi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakadate', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ishihara', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}]",Nutrients,['10.3390/nu12103034']
3100,33022968,Integrated Strength and Fundamental Movement Skill Training in Children: A Pilot Study.,"Competence in fundamental movement skills is essential to enable children to be physically active. We investigated the effect of an integrated fundamental movement skill with a strength training intervention on children's fundamental movement skills. Seventy-two (53% female) 10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance). Schools were randomly allocated to a control (no intervention; n = 21), fundamental movement skill (FMS) (n = 18) or FMS and strength (FMS + ; n = 20) group. Interventions were delivered twice weekly for four weeks, in addition to normal physical education. FMS competence was measured through the Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product). Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1). Clear improvements in CMJ were observed in FMS +  relative to the control (25, 18 to 32%,  p δ  = 0) and FMS groups (15, 6.1 to 24%,  p δ  = 0). These preliminary data suggest combined FMS and strength training warrants further investigation as a tool to develop fundamental movement skills in children.",2020,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1).","['Seventy-two (53% female', ""children's fundamental movement skills"", '10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance', 'children', 'Children']","['Integrated Strength and Fundamental Movement Skill Training', 'integrated fundamental movement skill with a strength training intervention', 'fundamental movement skill (FMS']","['Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product', 'FMS competence', 'CMJ']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0220531,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1).","[{'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Grainger', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Innerd', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}]","Children (Basel, Switzerland)",['10.3390/children7100161']
3101,33022987,Ingestion of  Helianthus tuberosus  at Breakfast Rather Than at Dinner Is More Effective for Suppressing Glucose Levels and Improving the Intestinal Microbiota in Older Adults.,"To date, nutritional studies have focused on the total intake of dietary fiber rather than intake timing. In this study, we examined the effect of the timing of daily  Helianthus   tuberosus  ingestion on postprandial and 24 h glucose levels, as well as on intestinal microbiota in older adults. In total, 37 healthy older adults (age = 74.9 ± 0.8 years) were recruited. The participants were randomly assigned to either a morning group (MG,  n  = 18) or an evening group (EG,  n  = 17). The MG and EG groups were instructed to take  Helianthus   tuberosus  powder (5 g/day) just before breakfast or dinner, respectively, for 1 week after the 1-week control period. The glucose levels of all participants were monitored using a continuous glucose monitoring system throughout the 2 weeks. The intestinal microbiota was analyzed by sequencing 16S rRNA genes from feces before and after the intervention. There were no significant differences in the physical characteristics or energy intake between groups.  Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively). As a result of examining the fluctuations in tissue glucose levels up to 4 hours after each meal, significant decreases in the areas under the curves (AUCs) were observed for all three meals after intervention, but only in the MG (breakfast:  p  = 0.012, lunch:  p  = 0.002, dinner:  p  = 0.005). On the other hand, in the EG, there was a strong decrease in the AUC after dinner, but only slight decreases after breakfast and lunch (breakfast:  p  = 0.017, lunch:  p  = 0.427, dinner:  p  = 0.002). Moreover, the rate of change in the peak tissue glucose level at breakfast was significantly decreased in the MG compared to the EG ( p  = 0.027). A greater decrease was observed in the change in the blood glucose level after the ingestion of  Helianthus   tuberosus  in the MG than in the EG. Furthermore, the relative abundance of  Ruminococcus  in the MG at the genus level was significantly higher at baseline than in the EG ( p  = 0.016) and it was also significantly lower after the intervention ( p  = 0.013). Our findings indicate that  Helianthus   tuberosus  intake in the morning might have relatively stronger effects on the intestinal microbiota and suppress postprandial glucose levels to a greater extent than when taken in the evening.",2020,"Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively).","['older adults', '37 healthy older adults (age = 74.9 ± 0.8 years) were recruited', 'Older Adults']","['morning group (MG,  n  = 18) or an evening group (EG,  n  = 17', 'Ingestion of  Helianthus tuberosus  at Breakfast']","['rate of change in the peak tissue glucose level at breakfast', 'glucose levels', 'postprandial glucose levels', 'blood glucose level', 'relative abundance of  Ruminococcus', 'tissue glucose levels', 'intestinal microbiota', 'postprandial and 24 h glucose levels', 'physical characteristics or energy intake']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022386', 'cui_str': 'Jerusalem artichoke'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",37.0,0.0193183,"Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively).","[{'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1, Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12103035']
3102,33022991,An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial.,"BACKGROUND


Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM.
METHODS


This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups.
RESULTS


A-LCD significantly improved depression and HbA1c ( p  <0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria  Roseburia ,  Ruminococcus  and  Eubacterium . The GLP-1 concentration in the a-LCD group was higher than that in the LFD group ( p  <0.05).
CONCLUSIONS


A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.",2020,A-LCD significantly improved depression and HbA1c ( p  <0.01).,"['Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group', 'Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second', 'Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1', 'patients with T2DM']","['LFD', 'LCD with a low-fat diet (LFD', 'Almond-Based Low Carbohydrate Diet', 'almond-based LCD (a-LCD', 'Alow carbohydrate diet (LCD']","['hyperglycemia and depression symptoms', 'glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration', 'GLP-1 concentration', 'depression and HbA1c', 'short chain fatty acid (SCFAs)-producing bacteria  Roseburia ,  Ruminococcus  and  Eubacterium ']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}]",45.0,0.0354016,A-LCD significantly improved depression and HbA1c ( p  <0.01).,"[{'ForeName': 'Mengxiao', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA 94110, USA.'}, {'ForeName': 'Jindan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}]",Nutrients,['10.3390/nu12103036']
3103,33035194,A proof-of-concept study on the impact of a chronic pain and physical activity training workshop for exercise professionals.,"Objectives Physical activity is essential for long-term chronic pain management, yet individuals struggle to participate. Exercise professionals, including fitness instructors, and personal trainers, are preferred delivery agents for education and instruction on chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills. However, exercise professionals receive no relevant training during certification or continuing education opportunities to effectively support their participants living with chronic pain. Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted. The purpose was to examine the impacts of a newly developed chronic pain and physical activity training workshop on psychosocial outcomes among exercise professionals. Outcomes included knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain. Methods Forty-eight exercise professionals (M age=44.4±11.0 years) participated in a three-hour, in-person workshop that was offered at one of four different locations. Participants completed pre- and post-workshop outcome assessment surveys. Results Mixed MANOVA results comparing time (pre- versus post-workshop) by workshop location (sites 1 to 4) illustrated a significant within-subjects time effect (p<0.001). All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59). Conclusions Findings offer early phase preliminary support for the effectiveness of the chronic pain and physical activity training workshop for exercise professionals. Based on ORBIT model recommendations, findings warrant future phased testing via a pilot randomized clinical trial as well as testing for impacts that trained professionals have on activity adherence among their clients living with chronic pain. Eventual workshop adoption by exercise professional certification organizations would ensure widespread and sustainable access to qualified exercise professionals to help individuals engage in physical activity. By increasing the capacity of available exercise professionals to deliver effective support, active individuals could better manage their chronic pain and live well.",2020,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","['participants living with chronic pain', 'clients living with chronic pain']","['physical activity training workshop', 'exercise professionals receive no relevant training during certification or continuing education opportunities']","['knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain', 'chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",48.0,0.0595817,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","[{'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Gyurcsik', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Tupper', 'Affiliation': 'Pain Quality Improvement and Research for the Saskatchewan Health Authority, Saskatoon, SK, Canada.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Brittain', 'Affiliation': 'University of Northern Colorado, College of Natural and Health Sciences, Greeley, CO, USA.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Miranda A', 'Initials': 'MA', 'LastName': 'Cary', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Ratcliffe-Smith', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Jocelyn E', 'Initials': 'JE', 'LastName': 'Blouin', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Mackenzie G', 'Initials': 'MG', 'LastName': 'Marchant', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sessford', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Laurie-Ann M', 'Initials': 'LM', 'LastName': 'Hellsten', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Arnold', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Downe', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0089']
3104,33035202,Comparison Between Percutaneous Transforaminal Endoscopic Discectomy and Fenestration in the Treatment of Degenerative Lumbar Spinal Stenosis.,"BACKGROUND This study aimed to investigate the therapeutic and prognostic effects of percutaneous transforaminal endoscopic decompression (PTED) for degenerative lumbar spinal stenosis (DLSS). MATERIAL AND METHODS One hundred eighty-eight patients with DLSS were randomly divided into the fenestration and the PTED group for decompression treatment. Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications in the 2 groups were compared. All patients underwent computed tomography (CT) scanning and magnetic resonance imaging (MRI) on the first postoperative day. All patients were assessed preoperatively and the treatment effects at 3, 6, and 12 months postoperatively were evaluated using visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI). The modified MacNab criteria were used to assess patient satisfaction 1 year after surgery at the last follow-up. RESULTS Patients who underwent PTED had shorter incisions, less blood loss, and shorter hospital stays than those in the fenestration group, but operative times and complication rates were similar in the 2 groups. Moreover, CT scanning and MRI revealed similar treatment effects in the 2 groups. Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups. In particular, all 3 scores in the PTED group were higher than those in the fenestration group at 3 and 6 months postoperatively. There were no significant differences in MacNab scores between the 2 groups. CONCLUSIONS PTED is safer and more effective than traditional fenestration for management of DLSS.",2020,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","['Degenerative Lumbar Spinal Stenosis', 'One hundred eighty-eight patients with DLSS', 'degenerative lumbar spinal stenosis (DLSS']","['computed tomography (CT) scanning and magnetic resonance imaging (MRI', 'percutaneous transforaminal endoscopic decompression (PTED', 'Percutaneous Transforaminal Endoscopic Discectomy and Fenestration']","['VAS, ODI, and JOA scores', 'operative times and complication rates', 'visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI', 'MacNab scores', 'Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications', 'blood loss, and shorter hospital stays']","[{'cui': 'C0410636', 'cui_str': 'Degenerative lumbar spinal stenosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",188.0,0.0207879,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Hengjie', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Chengcun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926631']
3105,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES


Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS


In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS


Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION


Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
3106,33017755,Admission Blood Pressure and Outcome of Endovascular Therapy: Secondary Analysis of ASTER Trial.,"BACKGROUND


Elevated blood pressure (BP) is common among patients presenting with acute ischemic stroke due to large vessel occlusions. The literature is inconsistent regarding the association between admission BP and outcome of mechanical thrombectomy (MT). Moreover, it is unclear whether the first line thrombectomy strategy (stent retriever [SR] versus contact aspiration [CA]) modifies the relationship between BP and outcome.
METHODS


This is a post hoc analysis of the ASTER (Contact Aspiration Versus Stent Retriever for Successful Revascularization) randomized trial. BP was measured prior to randomization in all included patients. Co-primary outcomes included 90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia [mTICI] 2b-3). Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH) within 24 hours.
RESULTS


A total of 381 patients were included in the present study. Mean (SD) systolic BP (SBP) and diastolic BP (DBP) were 148 (26) mm Hg and 81 (16) mm Hg, respectively. There was no association between SBP or DBP and successful revascularization or 90-day functional independence. Similarly, there was no association between admission SBP or DBP with sICH or PH. Subgroup analysis based on the first-line thrombectomy strategy revealed similar results with no heterogeneity across groups.
CONCLUSION


Admission BP was not associated with functional, angiographic or safety outcomes. Results were similar in both CA and CA groups.",2020,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"['patients presenting with acute ischemic stroke due to large vessel occlusions', 'A total of 381 patients were included in the present study']",['contact aspiration [CA'],"['Mean (SD) systolic BP (SBP) and diastolic BP (DBP', 'symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH', 'SBP or DBP and successful revascularization or 90-day functional independence', '90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia', 'Admission BP', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",381.0,0.0769627,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"[{'ForeName': 'Mohnammd', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, United States. Electronic address: manadani@wustl.edu.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center, Foch Hospital, Suresnes, France. Electronic address: bertrand.lapergue@gmail.com.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: rblanc29@gmail.com.'}, {'ForeName': 'Maéva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: maeva.kyheng@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: julien.labreuche.chru@gmail.com.'}, {'ForeName': 'Malek Ben', 'Initials': 'MB', 'LastName': 'Machaa', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mbenmaacha@for.paris.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: alain.duhamel59@gmail.com.'}, {'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, France. Electronic address: gaultier.marnat@chu-bordeaux.fr.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Saleme', 'Affiliation': 'Department of Interventional Neuroradiology, University Hospital of Limoges, France. Electronic address: suzanna.saleme@chu-limoges.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France. Electronic address: vincentcost@hotmail.com.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: s.bracard@chru-nancy.fr.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: r.anxionnat@gmail.com.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Spiotta', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, United States. Electronic address: spiotta@musc.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'DeHavenon', 'Affiliation': 'Department of Neurology, Utah University, Salt lake, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Université de Lorraine, INSERM U1116, Nancy, France. Electronic address: s.richard@chru-nancy.fr.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Department of Neuroradiology, Guillaume et René Laennec University Hospital, Nantes, France. Electronic address: hubert.desal@chu-nantes.fr.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mmazighi@for.paris.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Neuroradiology, Foch Hospital, Suresnes, France. Electronic address: a.consoli@hopital-foch.com.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mpiotin@for.paris.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: benjagory@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105347']
3107,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE


Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN


Double-blinded randomized placebo-controlled trial.
SETTING


Labor and delivery triage room.
PATIENTS


Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS


Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS


The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS


Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95%  = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95%  = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95%  = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95%  = -4.93, -0.34]; P = 0.025).
CONCLUSION


Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
3108,33019691,Dislodgement Forces and Cost Effectiveness of Dressings and Securement for Peripheral Intravenous Catheters: A Randomized Controlled Trial.,"OBJECTIVES


Peripheral intravenous catheters (PIVC) are the most frequently used invasive devices in medicine. PIVC failure before treatment completion is a significant concern and occurs in 33-69% of patients. Partial dislodgement and accidental removal are some of the reasons for PIVC failure. The most effective dressing and securement method for preventing accidental removal remains unclear. It was the aim of this study to compare the force required to dislodge a PIVC with four commonly used dressing and securement methods. Additionally, costs were calculated.
METHODS


Truncated 18-gauge i.v. cannulas were attached onto the forearm of 209 volunteers using four different dressings and securements (sterile absorbent wound dressing covered by two different types of elastic polyester fleece, bordered and non-bordered polyurethane). The force during continuously stronger pulling until dislodgement was recorded.
RESULTS


The highest resistance against dislodgement forces could be observed with a sterile absorbent wound dressing covered by two incised elastic polyester fleece dressings. Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
CONCLUSIONS


Elastic polyester fleece secured a PIVC against accidental removal by external force best, compared to commercially-manufactured bordered and non-bordered polyurethane film dressing.",2020,"Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
","['Peripheral Intravenous Catheters', '209 volunteers using four different']","['dressings and securements (sterile absorbent wound dressing covered by two different types of elastic polyester fleece, bordered and non-bordered polyurethane', 'Peripheral intravenous catheters (PIVC', 'Dressings and Securement']",['PIVC failure'],"[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0449485', 'cui_str': 'Type of elastic'}, {'cui': 'C0032474', 'cui_str': 'Polyester'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",209.0,0.0405353,"Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schmutz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Menz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Heinrich', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9103192']
3109,33022318,Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION


U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS


Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS


Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS


In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Cati', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
3110,33022321,Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population.,"Previous research suggests that sending non-participants a reminder letter, 1 year after their initial invitation, can improve coverage for bowel scope screening (BSS), also known as flexible sigmoidoscopy screening. We hypothesised that adding a general practitioner's (GPs) endorsement to the reminder letter could improve coverage even further. We conducted a randomised controlled trial in North West London, UK. Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12 months prior to the trial period. Eligible adults were randomised in a 1:1 ratio to receive either a GP-endorsed reminder letter, or a standard reminder letter from June to August 2019. Logistic regression models were used to test the effect of the GP endorsement on attendance at BSS, adjusting for sex, clinical commissioning group, and local area socioeconomic deprivation. In total, 1200 participants were enrolled into the study and randomised to either the control (n = 600) or the intervention (n = 600) group. Those who received the GP-endorsed reminder letter were only slightly more likely to attend BSS than those who received the standard reminder letter (4% vs. 3%); this difference was not statistically significant (Adjusted OR = 1.30; 95% CI: 0.69, 2.43). Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS. One possible explanation for this is that the endorsement used was not personalised enough. Future research should examine stronger GP-endorsements or other methods to promote uptake.",2020,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"['Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12\u202fmonths prior to the trial period', 'North West London, UK', 'Eligible adults', '1200 participants were enrolled into the study and randomised to either the control (n\u202f=\u202f600) or the intervention (n\u202f=\u202f600) group']","['GP-endorsed reminder letter, or a standard reminder letter from June to August 2019', 'GP-endorsed non-participant reminder letter']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],1200.0,0.121819,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK. Electronic address: aradhna.kaushal.14@ucl.ac.uk.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tookey', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106268']
3111,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
3112,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES


We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS


This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS


A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43)  = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS


Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
3113,33025648,A randomized controlled trial with a delayed-type hypersensitivity model using keyhole limpet haemocyanin to evaluate adaptive immune responses in man.,"AIMS


Keyhole limpet haemocyanin (KLH) immunization is a clinical model for the evaluation of human antibody responses. The current study evaluated the anti-KLH antibody response after KLH immunization and the delayed-type hypersensitivity response following intradermal KLH administration, using objective imaging techniques.
METHODS


Healthy male subjects aged 24.5 ± 5.4 years were randomized to intramuscular immunization with 100 μg KLH (n = 12) or placebo (n = 3). Anti-KLH antibody (Ig) M and IgG titres were determined before and every 7 days after KLH immunization for a total of 28 days. Twenty-one days after the immunization, all subjects received 1 μg KLH intradermally. Prior to and 2 days after intradermal KLH administration, skin blood perfusion, erythema and oedema were quantified using noninvasive imaging tools. Repeated measures ANCOVAs were used to analyse data.
RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference [ED]: 37%, 95% confidence interval [CI]: 19-51% and ED: 68%, 95% CI: 56-76% respectively). Upon intradermal KLH administration an increase in skin blood perfusion (ED: 10.9 arbitrary units (AU), 95% CI: 1.4-20.4 AU) and erythema (ED: 0.3 AU, 95% CI: 0.1-0.5 AU) was observed in KLH-immunized subjects compared to placebo.
CONCLUSION


KLH immunization followed by intradermal KLH administration resulted in increased anti-KLH IgM and IgG titres and a delayed-type hypersensitivity response quantified by an increase in skin blood perfusion and erythema. Using noninvasive imaging tools the KLH model has the potential to serve as an objective tool to study the pharmacodynamics of T-cell-directed immunomodulatory drugs.",2020,"RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference (ED): 37%, 95% confidence interval (CI): 19%-51% and ED: 68%, 95% CI: 56%-76% respectively).","['man', 'Healthy male subjects, aged 24.5 ± 5.4 years']","['KLH', 'intramuscular immunization with 100 μg KLH', 'placebo', 'delayed-type hypersensitivity model using keyhole limpet haemocyanin', 'Keyhole limpet haemocyanin (KLH) immunization']","['skin blood perfusion, erythema and oedema', 'Anti-KLH IgM and IgG titres', 'erythema (ED', 'skin blood perfusion and erythema', 'Anti-KLH antibody M (IgM) and IgG titres', 'delayed-type hypersensitivity (DTH) response', 'anti-KLH IgM and IgG titres and a DTH response', 'skin blood perfusion']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.107235,"RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference (ED): 37%, 95% confidence interval (CI): 19%-51% and ED: 68%, 95% CI: 56%-76% respectively).","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Saghari', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ziagkos', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Powell', 'Affiliation': 'Kymab Ltd, Cambridge, UK.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Brennan', 'Affiliation': 'Kymab Ltd, Cambridge, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Dermatology Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14588']
3114,33025690,Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?,"OBJECTIVE


We evaluated the ability of intravenous (IV) acetaminophen to reduce the amount of opioid medication administered in pediatric patients with sickle cell disease (SCD) having vasoocclusive crisis (VOC) in an emergency department (ED) setting.
METHODS


This was a prospective, randomized, double-blind placebo-controlled trial at an academic urban pediatric ED. Participants included patients with SCD, aged 4 to 16 years, with VOC pain. All patients received a 0.1 mg/kg dose of IV morphine, 0.5 mg/kg ketorolac, or both. Patients were randomized to receive either 15 mg/kg IV acetaminophen or placebo. Patients were reassessed every 30 minutes to see whether additional opioid doses were indicated to a maximum of three doses. The total morphine given, pain scores, rates of admissions, 72-hour return visits, and adverse events were assessed for each group.
RESULTS


Of 71 subjects randomized, 35 patients in the acetaminophen group and 36 patients in the control group were analyzed. Baseline characteristics and initial pain scores were similar in both groups. The mean total amount of morphine given was 8.6 mg (95% confidence interval [CI] = 6.5 to 10.8) in the acetaminophen group and 8.0 mg (95% CI = 5.9 to 10.2) in the placebo group. The mean total cumulative morphine dosing was 0.2 mg/kg (95% CI = 0.1 to 0.2 mg/kg) in the acetaminophen group and 0.2 mg/kg (95% CI = 0.1 to 0.2 mg/kg) in the control group. The mean pain score at time of disposition was 5.5 (95% CI = 4.3 to 6.6) in the acetaminophen group and 5.2 (95% CI = 4.2 to 6.3) in the placebo group. There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
CONCLUSION


In this study, patients who received IV acetaminophen did not receive less morphine than patients in the placebo group. Disposition pain scores for the two groups were also equivalent. We conclude that IV acetaminophen, when used in addition to morphine for pediatric sickle cell VOC pain, does not provide an opioid-sparing effect. Further searches for adjunctive nonaddictive pain medicines are indicated.",2020,"There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
","['academic urban pediatric ED', 'pediatric patients with sickle cell disease (SCD) having vaso-occlusive crisis (VOC) in an emergency department (ED) setting', '71 subjects randomized, 35 patients in the', 'Pediatric Emergency Department Patients with Acute Sickle Cell Crises', 'pediatric sickle cell VOC pain', 'Participants included patients with SCD, aged 4-16 years, with VOC pain']","['acetaminophen', 'Acetaminophen', 'acetaminophen or placebo', 'placebo', 'intravenous (IV) acetaminophen', 'morphine', 'IV morphine, 0.5 mg/kg ketorolac']","['Baseline characteristics and initial pain scores', 'rates of admission, 72-hour return visits, or adverse events', 'mean total cumulative morphine', 'mean total amount morphine', 'total morphine given, pain scores, rates of admissions, 72-hour return visits, and adverse events', 'mean pain score at time of disposition', 'Disposition pain scores']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0238425', 'cui_str': 'Hemoglobin SS disease with crisis'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}]",71.0,0.589693,"There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Dhebaria', 'Affiliation': ""From the, Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sivitz', 'Affiliation': ""From the, Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}, {'ForeName': 'Cena', 'Initials': 'C', 'LastName': 'Tejani', 'Affiliation': ""From the, Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14149']
3115,33030273,Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial.,"OBJECTIVE


Increasing magnesium intake might reduce the risk of cardiovascular disease (CVD). Whether potential effects on cortisol contribute to these beneficial effects on cardiovascular health remains unclear. We therefore studied effects of long-term oral magnesium supplementation on glucocorticoid metabolism, specifically on the excretion of urinary cortisol, cortisone and their metabolites, as well as on the ratios reflecting enzymatic activity of 11β-hydroxysteroid dehydrogenases (11β-HSDs) and A-ring reductases.
DESIGN


A post-hoc analysis of a randomized trial with allocation to a magnesium supplement (350 mg/day) or a placebo for 24-week.
PATIENTS


Forty-nine overweight men and women, aged between 45 and 70 years.
MEASUREMENTS


Cortisol, cortisone and their metabolites (tetrahydrocortisol [THF], allo-tetrahydrocortisol [allo-THF] and tetrahydrocortisone [THE]) were measured in 24-h urine samples. Enzymatic activities of 11β-HSD overall and of 11β-HSD type 2 were estimated as the urinary (THF + allo-THF [THFs])/THE and cortisol/cortisone ratios, respectively. A-ring reductase activity was assessed by ratios of THF/allo-THF, allo-THF/cortisol, THF/cortisol and THE/cortisone.
RESULTS


After 24-week, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, p = .021). Ratios of THFs/THE and cortisol/cortisone were decreased following magnesium supplementation by 0.09 (95% CI: 0.02; 0.17, p = .018) and 0.10 (95% CI: 0.03; 0.17, p = .005), respectively. No effects were observed on A-ring reductase activity.
CONCLUSIONS


We observed a beneficial effect of magnesium supplementation towards a lower 24-h urinary cortisol excretion together with an increased activity of 11β-HSD type 2. Our findings may provide another potential mechanism by which increased magnesium intake lowers CVD risk (ClinicalTrials.gov identifier: NCT02235805).",2020,"After 24-wk, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, P=0.021).","['Forty-nine overweight men and women, aged between 45-70 years']","['placebo', 'magnesium supplement', 'magnesium supplementation']","['Cortisol, cortisone, and their metabolites (tetrahydrocortisol [THF], allo-tetrahydrocortisol [allo-THF], and tetrahydrocortisone [THE', 'excretion of urinary cortisol, cortisone, and their metabolites', 'Ratios of THFs/THE and cortisol/cortisone', 'glucocorticoid metabolism', '24-h urinary cortisol excretion', 'Enzymatic activities of 11β-HSD overall and of 11β-HSD type 2', 'urinary (THF + allo-THF [THFs])/THE and cortisol/cortisone ratios', 'urinary cortisol excretion']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268858', 'cui_str': 'Magnesium supplement agent'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0039664', 'cui_str': 'Tetrahydrocortisol'}, {'cui': 'C0051222', 'cui_str': '3-alpha-allo-tetrahydrocortisol'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1837657', 'cui_str': 'CHST3-related skeletal dysplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",49.0,0.264381,"After 24-wk, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, P=0.021).","[{'ForeName': 'Joëlle C', 'Initials': 'JC', 'LastName': 'Schutten', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Isidor', 'Initials': 'I', 'LastName': 'Minović', 'Affiliation': 'Department of Laboratory Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Post', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'van Beek', 'Affiliation': 'Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}]",Clinical endocrinology,['10.1111/cen.14350']
3116,33030304,Circulating lipids in men with type 2 diabetes following 3 days on a carbohydrate-free diet versus 3 days of fasting.,"OBJECTIVE


We have been interested in determining the effects of dietary changes on fuel metabolism and regulation in men with type 2 diabetes mellitus (T2DM). In this study, the changes in 24-hr circulating lipid profiles were determined when the major fuel source was endogenous versus exogenous fat.
METHODS


Seven males with T2DM were randomized in a crossover design with a 4-week washout period. A standard mixed (control) diet (30%fat:15%protein:55%carbohydrate) was provided initially. Subsequently, a 72-hr (3-day) fast, or a high fat (85%), 15% protein, essentially carbohydrate-free (CHO-free) diet was provided for 72 hr. Triacylglycerol (TAG), non-esterified fatty acids (NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1 (IGFBP-1) profiles were determined during the last 24 hr of intervention, as well as during the control diet.
RESULTS


Regardless of the amount of dietary fat (30% vs 85%) and differences in 24-hr profiles, TAG, NEFA, and bHB all returned to the previous basal concentrations within 24 hr. TAGs and NEFAs changed only modestly with fasting; bHB was elevated and increasing. The IGFBP-1 profile was essentially unchanged with either diet but increased with fasting.
CONCLUSION


A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning. A negative NEFA profile occurred with the control diet. Thus, mechanisms are present to restore lipid concentrations to their original AM concentrations daily. Fasting resulted in stable concentrations, except for a continuing increase in bHB. Glucose and insulin, common fuel regulators, could not explain the results.",2020,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","['men with type 2 diabetes', 'Seven males with T2DM', 'men with type 2 diabetes mellitus (T2DM']","['standard mixed (control) diet (30%fat:15%protein:55%carbohydrate', 'carbohydrate-free diet']","['Triacylglycerol (TAG), non-esterified fatty acids', 'Circulating lipids', '24-hr circulating lipid profiles', '24-hr profiles, TAG, NEFA, and bHB', 'IGFBP-1 profile', 'NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1', 'bHB']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452308', 'cui_str': 'Carbohydrate-free diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",7.0,0.013052,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","[{'ForeName': 'Frank Q', 'Initials': 'FQ', 'LastName': 'Nuttall', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rami M', 'Initials': 'RM', 'LastName': 'Almokayyad', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Gannon', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}]",Physiological reports,['10.14814/phy2.14569']
3117,33030312,Responding to the ECHO trial results: modelling the potential impact of changing contraceptive method mix on HIV and reproductive health in South Africa.,"INTRODUCTION


Some observational data suggest that the progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA) may increase a woman's risk of HIV acquisition but a randomized clinical trial did not find a statistically significant increase in HIV risk for women using DMPA compared to two other methods. However, it could not rule out up to 30% increased HIV risk for DMPA users. We evaluate changes to contraceptive method mix in South Africa under different assumptions about the existence and strength of a possible undetected relationship between DMPA use and HIV risk.
METHODS


A mathematical model was developed to simulate the ongoing HIV epidemic and contraceptive method mix in South Africa to estimate how changes in method mix could impact HIV- and reproductive health-related outcomes. We made different assumptions about the relationship between DMPA use and HIV risk, from no relationship to a 30% increase in HIV risk for women using DMPA. Scenario analyses were used to investigate the impact of switching away from DMPA predominance to new patterns of contraceptive use.
RESULTS


In South Africa, the HIV-related benefits of reduced DMPA use could be as great as the harms of increased adverse reproductive health outcomes over 20 years, if DMPA did increase the risk of HIV acquisition by a relative hazard of infection of 1.1 or greater. A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes. The most important driver of adverse reproductive health outcomes is the proportion of women who switch away from DMPA to no contraceptive method.
CONCLUSIONS


If there is any real increased HIV risk for DMPA users that has not been detected by the recent randomized trial, a reduction in DMPA use could reduce the ongoing number of new HIV infections. However, such a change would place more women at risk of adverse reproductive health effects. It is imperative that these effects are minimized by focusing on expanding access to safe, effective and acceptable alternative contraceptive methods for all women.",2020,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","['women who switch away from DMPA to no contraceptive method', 'HIV and reproductive health in South Africa']",['progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA'],"['HIV risk', 'risk of HIV acquisition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.260324,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Beacroft', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fareed', 'Initials': 'F', 'LastName': 'Abdullah', 'Affiliation': 'Office of AIDS and TB Research, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Buyile', 'Initials': 'B', 'LastName': 'Buthelezi', 'Affiliation': 'USAID, Pretoria, South Africa.'}, {'ForeName': 'Manala', 'Initials': 'M', 'LastName': 'Makua', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Morroni', 'Affiliation': 'Botswana Harvard AIDS Institute, Gaborone, Botswana.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'Aurum Institute, Parktown, South Africa.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Velasquez', 'Affiliation': 'UNAIDS Eastern and Southern Africa, Johannesburg, South Africa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}]",Journal of the International AIDS Society,['10.1002/jia2.25620']
3118,33043883,DMT alters cortical travelling waves.,"Psychedelic drugs are potent modulators of conscious states and therefore powerful tools for investigating their neurobiology. N,N, Dimethyltryptamine (DMT) can rapidly induce an extremely immersive state of consciousness characterized by vivid and elaborate visual imagery. Here, we investigated the electrophysiological correlates of the DMT-induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed. Consistent with our hypotheses, results revealed a spatio-temporal pattern of cortical activation (i.e. travelling waves) similar to that elicited by visual stimulation. Moreover, the typical top-down alpha-band rhythms of closed-eyes rest were significantly decreased, while the bottom-up forward wave was significantly increased. These results support a recent model proposing that psychedelics reduce the 'precision-weighting of priors', thus altering the balance of top-down versus bottom-up information passing. The robust hypothesis-confirming nature of these findings imply the discovery of an important mechanistic principle underpinning psychedelic-induced altered states.",2020,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.",[],"['placebo (saline', 'Dimethyltryptamine (DMT', 'DMT']",['typical top-down alpha-band rhythms of closed-eyes rest'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0411564,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alamia', 'Affiliation': 'Cerco, CNRS Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Timmermann', 'Affiliation': 'Computational, Cognitive and Clinical Neuroscience Laboratory (C3NL), Faculty of Medicine, Imperial College, London, United Kingdom.'}, {'ForeName': 'Rufin', 'Initials': 'R', 'LastName': 'VanRullen', 'Affiliation': 'Cerco, CNRS Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Centre for Psychedelic Research, Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}]",eLife,['10.7554/eLife.59784']
3119,33040092,Attention-deficit/hyperactivity disorder and the explore/exploit trade-off.,"The ability to maximize rewards and minimize the costs of obtaining them is vital to making advantageous explore/exploit decisions. Exploratory decisions are theorized to be greater among individuals with attention-deficit/hyperactivity disorder (ADHD), potentially due to deficient catecholamine transmission. Here, we examined the effects of ADHD status and methylphenidate, a common ADHD medication, on explore/exploit decisions using a 6-armed bandit task. We hypothesized that ADHD participants would make more exploratory decisions than controls, and that MPH would reduce group differences. On separate study days, adults with (n = 26) and without (n = 23) ADHD completed the bandit task at baseline, and after methylphenidate or placebo in counter-balanced order. Explore/exploit decisions were modeled using reinforcement learning algorithms. ADHD participants made more exploratory decisions (i.e., chose options without the highest expected reward value) and earned fewer points than controls in all three study days, and methylphenidate did not affect these outcomes. Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants. These results support several theoretical models of increased exploratory choices in ADHD and suggest the unexplained variance in ADHD decisions may be due to less value tracking. The inability to suppress actions with little to no reward value may be a key feature of hyperactive ADHD symptoms.",2020,Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants.,"['individuals with attention-deficit/hyperactivity disorder (ADHD', 'adults with (n\u2009=\u200926) and without (n\u2009=\u200923) ADHD completed the bandit task at baseline, and after']","['methylphenidate or placebo', 'methylphenidate']","['hyperactive ADHD symptoms', 'exploratory decisions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0517165,Baseline exploratory choices were positively associated with hyperactive ADHD symptoms across all participants.,"[{'ForeName': 'Merideth A', 'Initials': 'MA', 'LastName': 'Addicott', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA. maddicott@uams.edu.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pearson', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Schechter', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Sapyta', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Margaret D', 'Initials': 'MD', 'LastName': 'Weiss', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00881-8']
3120,33045290,Catheter Removal on the Same Day of Holmium Laser Enucleation of the Prostate: Outcomes of a Pilot Study.,"OBJECTIVES


To determine if same day catheter removal is feasible in select population after holmium laser enucleation of the prostate (HoLEP).
METHODS


We performed an analysis of patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP. All HoLEPs were performed with Moses Optimized for BPH. Patients were dismissed from postoperative recovery unit (POCU) to the clinic for catheter removal and voiding trial.
RESULTS


To date, 30 patients have undergone same day catheter removal. Median age is 68.6 years (IQR 61.8-73.3) and preoperative prostate volume 81 ml (IQR 53-114.8). Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  27 (90%) patients successfully voided on the same day without requiring catheter replacement. All patients were catheter free by POD1. For patients who successfully passed their voiding trial, the median time from the end of the procedure to hospital discharge was 2.6 hours (IQR (2.1-2.9) and from the end of the HoLEP to catheter removal was 4.9 hours (IQR 3.5-6.0).
CONCLUSIONS


We present for the first time that same day catheter removal is a feasible option in a select population of patients undergoing HoLEP. With more study, this has the potential for transforming the management of BPH, especially larger glands.",2020,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","['patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP', 'patients undergoing HoLEP', '30 patients have undergone same day catheter removal', 'select population after holmium laser enucleation of the prostate (HoLEP']",['Holmium Laser Enucleation'],"['hospital discharge', 'morcellation time', 'enucleated specimen weight', 'HoLEP to catheter removal', 'Median enucleation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0546925,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","[{'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Agarwal', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Marcelino E', 'Initials': 'ME', 'LastName': 'Rivera', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Charles U', 'Initials': 'CU', 'LastName': 'Nottingham', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Krambeck', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN. Electronic address: akrambeck@iuhealth.org.'}]",Urology,['10.1016/j.urology.2020.09.038']
3121,33045501,Changes in fetoplacental Doppler indices following intrapartum maternal sildenafil citrate treatment.,"OBJECTIVE


Uterine contractions during labour can result in a 60 % decline in fetoplacental perfusion, predisposing the fetus to hypoxic brain injury. Sildenafil citrate (SC) has shown promise in increasing uteroplacental perfusion as well as reducing the risk of operative birth for intrapartum fetal compromise (IFC). The aim of this study was to investigate the effect of intrapartum SC administration on fetoplacental blood flow indices.
METHODS


This was a subgroup analysis from an earlier Phase II double blind randomized controlled trial; assessing the effect of intrapartum SC administration (50 mg orally 8 -hly in labour) compared to placebo for the reduction of operative birth for IFC. An ultrasound scan measuring fetoplacental Doppler indices was performed prior to and 1-4 h after the administration of the first treatment dose.
RESULTS


Of the 300 women randomized to the main study, pre-treatment ultrasound scans were performed in 261 participants who received the study medication; paired pre- and post-treatment scans were performed in 70 (26.8 %). SC resulted in an increase in the middle cerebral artery pulsatility index (PI) z-score [+0.08 (1.35) vs.-0.12 (1.15)], a decline in the umbilical artery-PI z-score [-0.07 (0.96) vs. + 0.04 (1.25)] and an increase in the cerebroplacental ratio [MCA-PI/UA-PI] (CPR) z-score [+0.10 (1.13) vs.-0.26 (1.14)] although these failed to reach statistical significance. Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
CONCLUSION


Although the differences in Doppler indices pre- and post- SC treatment were non-significant, there was a clear trend towards a reduction in the UA PI, a corresponding increase in the MCA PI and a rise in post treatment CPR values suggesting potential improvement in fetoplacental Dopplers with intrapartum SC treatment. However this study was limited by the small sample size. The results of this hypothesis generating study suggest that it may be possible to stratify women that would most benefit from this intervention based upon their pre-labour CPR.",2020,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
",['300 women randomized to the main study'],"['intrapartum SC administration (50\u2009mg orally 8\u2009-hly in labour', 'placebo', 'SC', 'Sildenafil citrate (SC', 'intrapartum SC']","['fetoplacental blood flow indices', 'cerebroplacental ratio', 'risk of operative birth for IFC', 'middle cerebral artery pulsatility index (PI) z-score', 'fetoplacental Doppler indices', 'umbilical artery-PI z-score']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",300.0,0.176329,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.042']
3122,33030436,Effect of Spatial Disorientation in a Virtual Environment on Gait and Vital Features in Patients with Dementia: Pilot Single-Blind Randomized Control Trial.,"BACKGROUND


Orientation deficits are among the most devastating consequences of early dementia. Digital navigation devices could overcome these deficits if adaptable to the user's needs (ie, provide situation-aware, proactive navigation assistance). To fulfill this task, systems need to automatically detect spatial disorientation from sensors in real time. Ideally, this would require field studies consisting of real-world navigation. However, such field studies can be challenging and are not guaranteed to cover sufficient instances of disorientation due to the large variability of real-world settings and a lack of control over the environment.
OBJECTIVE


Extending a foregoing field study, we aim to evaluate the feasibility of using a sophisticated virtual reality (VR) setup, which allows a more controlled observation of disorientation states and accompanying behavioral and physiological parameters in cognitively healthy older people and people with dementia.
METHODS


In this feasibility study, we described the experimental design and pilot outcomes of an ongoing study aimed at investigating the effect of disorientation on gait and selected physiological features in a virtual laboratory. We transferred a real-world navigation task to a treadmill-based virtual system for gait analysis. Disorientation was induced by deliberately manipulating landmarks in the VR projection. Associated responses in motion behavior and physiological parameters were recorded by sensors. Primary outcomes were variations in motion and physiological parameters, frequency of disorientation, and questionnaire-derived usability estimates (immersion and perceived control of the gait system) for our population of interest. At this time, the included participants were 9 cognitively healthy older participants [5/9 women, 4/9 men; mean age 70 years, SD 4.40; Mini-Mental State Examination (MMSE) mean 29, SD 0.70) and 4 participants with dementia (2/4 women, 2/4 men; mean age 78 years, SD 2.30 years; MMSE mean 20.50, SD 7.54). Recruitment is ongoing, with the aim of including 30 cognitively healthy older participants and 20 participants with dementia.
RESULTS


All 13 participants completed the experiment. Patients' route was adapted by shortening it relative to the original route. Average instances of disorientation were 21.40, 36.50, and 37.50 for the cognitively healthy older control, cognitively healthy older experimental participants, and participants with dementia, respectively. Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment. Variations were also observed in motion and physiological parameters during instances of disorientation.
CONCLUSIONS


This study presents the first feasibility outcomes of a study investigating the viability of using a sophisticated VR setup, based on an earlier real-world navigation study, to study spatial disorientation among cognitively healthy older people and people with dementia. Preliminary outcomes give confidence to the notion that our setup can be used to assess motion and physiological markers of disorientation, even in people with cognitive decline.
TRIAL REGISTRATION


ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT04134806.",2020,"Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment.","['cognitively healthy older control, cognitively healthy older experimental participants, and participants with dementia, respectively', '30 cognitively healthy older participants and 20 participants with dementia', 'people with cognitive decline', 'cognitively healthy older people and people with dementia', 'participants were 9 cognitively healthy older participants [5/9 women, 4/9 men; mean age 70 years, SD 4.40; Mini-Mental State Examination (MMSE) mean 29, SD 0.70) and 4 participants with dementia (2/4 women, 2/4 men; mean age 78 years, SD 2.30 years; MMSE mean 20.50, SD 7.54', 'Patients with Dementia']","['Spatial Disorientation', 'sophisticated virtual reality (VR) setup', 'Digital navigation devices']","['motion behavior and physiological parameters', 'Gait and Vital Features', 'variations in motion and physiological parameters, frequency of disorientation, and questionnaire-derived usability estimates (immersion and perceived control of the gait system']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0422893', 'cui_str': 'Spatial disorientation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",9.0,0.132761,"Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment.","[{'ForeName': 'Chimezie O', 'Initials': 'CO', 'LastName': 'Amaefule', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüdtke', 'Affiliation': 'Institute of Visual & Analytic Computing, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirste', 'Affiliation': 'Institute of Visual & Analytic Computing, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}]",JMIR serious games,['10.2196/18455']
3123,33027246,The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.,"BACKGROUND


Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.
METHODS AND FINDINGS


We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention.
CONCLUSIONS


We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov under registration number NCT02626351.",2020,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","['primary care clinics in rural South Africa', '7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months', 'All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment', 'rural South Africa', 'Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis', 'rural African communities']","['CQI to usual standard of antenatal care (ANC', 'CQI', 'trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions']","['coverage of antenatal HIV care tests', 'adverse events', 'quality of antenatal HIV care', 'repeat HIV testing', 'HIV prevalence', 'VL monitoring', 'viral load (VL) monitoring']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",2160.0,0.110171,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","[{'ForeName': 'H Manisha', 'Initials': 'HM', 'LastName': 'Yapa', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Terusha', 'Initials': 'T', 'LastName': 'Chetty', 'Affiliation': 'Health systems Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Awachana', 'Initials': 'A', 'LastName': 'Jiamsakul', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Harling', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dhlomo-Mphatswe', 'Affiliation': 'School of Clinical Medicine, Discipline of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Moshabela', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Global Health Institute, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Dickman', 'Initials': 'D', 'LastName': 'Gareta', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Kobus', 'Initials': 'K', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003150']
3124,33027362,Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial.,"PURPOSE


To assess the effect of antibiotic prophylaxis on surgical site infection (SSI) rates in women undergoing breast cancer surgery in two tertiary hospitals in Brazil.
METHODS


This was a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 124 women without independent risk factors for SSI were randomly assigned to receive either cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis. After surgery, all surgical wounds were examined once a week, for four weeks, according to the Centers for Disease Control and Prevention definitions and classifications for SSI.
RESULTS


Baseline characteristics were homogeneous between the two groups. Only one patient in the antibiotic group developed SSI, which was classified as superficial incisional. The overall SSI rate was low, with no significant difference between groups.
CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.",2020,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","['women undergoing breast cancer surgery in two tertiary hospitals in Brazil', '124 women without independent risk factors for SSI', 'breast cancer surgery']","['antibiotic prophylaxis', 'placebo', 'cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis', 'Antibiotic prophylaxis']","['surgical site infection (SSI) rates', 'overall SSI rate', 'SSI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",124.0,0.590906,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","[{'ForeName': 'Rubens Murilo de Athayde', 'Initials': 'RMA', 'LastName': 'Prudencio', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, Universidade do Vale do Sapucaí (UNIVÁS), Pouso Alegre-MG, and Breast Cancer Unit, Hospital São Cristóvão, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Fabíola Soares Moreira', 'Initials': 'FSM', 'LastName': 'Campos', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, and Hospital das Clínicas Samuel Libânio, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Ana Beatriz Alkmim Teixeira', 'Initials': 'ABAT', 'LastName': 'Loyola', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}, {'ForeName': 'Ivanildo', 'Initials': 'I', 'LastName': 'Archangelo Junior', 'Affiliation': 'MD, Department of Breast Surgery, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition of data; final approval.'}, {'ForeName': 'Neil Ferreira', 'Initials': 'NF', 'LastName': 'Novo', 'Affiliation': 'PhD, Full Professor, Department of Biostatistics, UNIVÁS, Pouso Alegre-MG, Brazil. Interpretation of data, statistical analysis, critical revision, final approval.'}, {'ForeName': 'Lydia Masako', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': 'PhD, Chairwoman, Head, Postgraduate Program in Translational Surgery, Division of Plastic Surgery, Universidade Federal de São Paulo (UNIFESP), Sao Paulo-SP, Brazil. Critical revision, final approval.'}, {'ForeName': 'Daniela Francescato', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, and Postgraduate Program in Translational Surgery, UNIFESP, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}]",Acta cirurgica brasileira,['10.1590/s0102-865020200090000007']
3125,33027942,Polyphenol Bioavailability and Plasma Antiradical Capacity in Healthy Subjects after Acute Intake of Pigmented Rice: A Crossover Randomized Controlled Clinical Trial.,"Health-promoting effects of plant foods have been emphasized in the last few decades and ascribed to the bioactive phytochemicals present therein-in particular, phenylpropanoids. The latter have been investigated for a number of preclinical biological activities, including their antioxidant power. Due to the paucity of human studies, in this randomized intervention trial, we investigated whether the acute intake of pigmented rice could increase the plasma bioactive levels and antiradical power in twenty healthy subjects. A crossover randomized controlled clinical trial was conducted on 19 volunteers. Artemide and Venere black rice cultivars were tested, while brown rice Carnaroli was used as a control. Each patient received randomly one serving (100 g) of rice on three different experimental days, separated by a 7-day washout period. After baseline blood withdrawal, time-course changes of plasma polyphenols, flavonoids and radical-scavenging capacity were determined at 30, 60, 120 and 180 min post rice intake. Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption. Pigmented rice consumption can contribute to diet-related health benefits in humans.",2020,"Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption.","['humans', '19 volunteers', 'Healthy Subjects after Acute Intake of Pigmented Rice', 'twenty healthy subjects']",[],"['plasma levels of polyphenols and flavonoids', 'plasma bioactive levels and antiradical power', 'plasma antiradical power', 'plasma polyphenols, flavonoids and radical-scavenging capacity', 'Polyphenol Bioavailability and Plasma Antiradical Capacity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",19.0,0.0232442,"Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vitalini', 'Affiliation': 'Department of Agricultural and Environmental Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sardella', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fracassetti', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Secli', 'Affiliation': 'ASST Santi Paolo e Carlo-Presidio Ospedaliero San Paolo-Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tirelli', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lodi', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carrassi', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Elena Maria', 'Initials': 'EM', 'LastName': 'Varoni', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Iriti', 'Affiliation': 'Department of Agricultural and Environmental Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9103209']
3126,33027966,Improvement of Dietary Diversity and Attitude toward Recommended Feeding through Novel Community Based Nutritional Education Program in Coastal Kenya-An Intervention Study.,"Community-based nutritional intervention to improve the practice of dietary diversity and child nutrition by community health workers (CHWs) involving Nyumba Kumi as small neighborhood units (SNUs) in communities has not yet been explored. This study was conducted in two villages in rural Kenya between 2018 and 2019. In total, 662 participants (control vs. intervention:  n  = 339 vs.  n  = 323) were recruited. The intervention group received education on maternal and child nutrition and follow-up consultations. The custom-tailored educational guidelines were made based on Infant and Young Child Feeding and the mother and child health booklet. The educational effects on household caregivers' feeding practice attitude and child nutritional status were analyzed using multiple linear regression. After the intervention, a total of 368 household caregivers (187 vs. 181) and 180 children (113 vs. 67) were analyzed separately. Between the groups, no significant difference was found in their background characteristics. This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01). The results revealed that the interventions using CHWs and SNUs were useful to improve dietary diversity and caregivers' attitudes toward recommended feeding. This research has the potential to be successfully applied in other regions where child undernutrition remains.",2020,This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01).,"['368 household caregivers (187 vs. 181) and 180 children (113 vs. 67) were analyzed separately', '662 participants (control vs. intervention:  n  = 339 vs.  n  = 323) were recruited', 'two villages in rural Kenya between 2018 and 2019']","['education on maternal and child nutrition and follow-up consultations', 'Community-based nutritional intervention']","[""dietary diversity and caregivers' attitudes"", 'dietary diversity score', 'attitude score']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",662.0,0.0152083,This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01).,"[{'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Hitachi', 'Affiliation': 'Program for Nurturing Global Leaders in Tropical and Emerging Communicable Diseases, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Wanjihia', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Nyandieka', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Chepkirui', 'Initials': 'C', 'LastName': 'Francesca', 'Affiliation': 'Department of Community Health and Epidemiology, School of Public Health, Kenyatta University, Nairobi 43844-00100, Kenya.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Wekesa', 'Affiliation': 'Kenya Medical Research Institute, KEMRI graduate school, Nairobi 54840-00200, Kenya.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Changoma', 'Affiliation': 'NUITM-KEMRI Project, Institute of Tropical Medicine (NUITM), Nagasaki University, Nairobi 19993-00202, Kenya.'}, {'ForeName': 'Erastus', 'Initials': 'E', 'LastName': 'Muniu', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Ndemwa', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Sumihisa', 'Initials': 'S', 'LastName': 'Honda', 'Affiliation': 'Department of Nursing, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hirayama', 'Affiliation': 'Department of Immunogenetics, Institute of Tropical Medicine, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Karama', 'Affiliation': 'Kenya Medical Research Institute, KEMRI graduate school, Nairobi 54840-00200, Kenya.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Eco-epidemiology, Institute of Tropical Medicine, Nagasaki University, Nagasaki 852-8523, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17197269']
3127,33028030,Narrative Voice Matters! Improving Smoking Prevention with Testimonial Messages through Identification and Cognitive Processes.,"Narrative messages are increasingly being used in the field of tobacco prevention. Our study is based on narrative persuasion and aims to analyze the psychological mechanisms that explain why the narrative voice is relevant to promote persuasive impact. An online experiment with a 2 (narrative voice) × 2 (message) factorial design was carried out. Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message). To increase the external validity of the study, two different messages were used within each condition. After reading the narrative message the mediating and dependent variables were evaluated. Participants who read the narrative in the first person experienced greater identification. Moreover, mediational analysis showed that both counterarguing and cognitive elaboration played a significant role in the relationship between narrative voice, identification, and persuasive impact. This study confirm that narrative voice is not only an anecdotal formal choice but that it indirectly affects variables related to tobacco prevention, due to the fact that first-person messages activate a mechanism of affective connection with the message (increasing the identification with the protagonist) that decreases resistance to prevention (the counterarguing process) while simultaneously stimulating reflection or cognitive elaboration.",2020,Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message).,['Participants (525 adult smokers'],[],['external validity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",525.0,0.0168639,Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message).,"[{'ForeName': 'Juan-José', 'Initials': 'JJ', 'LastName': 'Igartua', 'Affiliation': 'Department of Sociology and Communication, Faculty of Social Sciences, Campus Unamuno (Edificio FES), 37007 Salamanca, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rodríguez-Contreras', 'Affiliation': 'Department of Sociology and Communication, Faculty of Social Sciences, Campus Unamuno (Edificio FES), 37007 Salamanca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17197281']
3128,33028396,"Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial.","BACKGROUND


Natural products may provide a source for the discovery and development of adjunctive pharmacological interventions to modulate the inflammatory pathways contributing to chronic disease. Xanthohumol, a flavonoid from the hops plant (Humulus lupulus), has antioxidant and anti-inflammatory properties and may act as a prebiotic to the intestinal microbiota. Xanthohumol is not currently approved as a drug by the US Food and Drug Administration (FDA), but is available as a dietary supplement and ingredient in medical foods. To formally test the safety of xanthohumol, a phase I clinical trial (""XMaS"") was designed and approved under an Investigational New Drug application to the US FDA. The main objective is to examine the clinical safety and subjective tolerability of xanthohumol in healthy adults compared to placebo. Additional aims are to monitor biomarkers related to inflammation, gut permeability, bile acid metabolism, routes, and in vivo products of xanthohumol metabolism, and to evaluate xanthohumol's impact on gut microbial composition.
METHODS


The safety and tolerability of xanthohumol in healthy adults will be evaluated in a triple-masked, randomized, placebo-controlled trial. Participants will be randomized to either 24 mg/day of xanthohumol or placebo for 8 weeks. Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks. Participants will be queried for adverse events throughout the trial. Xanthohumol metabolites in blood, urine, and stool will be measured. Biomarkers to be evaluated include plasma tumor necrosis factor-alpha, various interleukins, soluble CD14, lipopolysaccharide-binding protein, fecal calprotectin, and bile acids to assess impact on inflammatory and gut permeability-related mechanisms in vivo. Stool samples will be analyzed to determine effects on the gut microbiome.
DISCUSSION


This phase I clinical trial of xanthohumol will assess safety and tolerability in healthy adults, collect extensive biomarker data for assessment of potential mechanism(s), and provide comparison data necessary for future phase II trials in chronic disease(s). The design and robustness of the planned safety and mechanistic evaluations planned provide a model for drug discovery pursuits from natural products.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03735420 . Registered on November 8, 2018.",2020,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.",['healthy adults'],"['xanthohumol or placebo', 'Xanthohumol', 'placebo', 'Xanthohumol microbiome', 'xanthohumol']","['safety and tolerability', 'clinical safety and subjective tolerability', 'Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures', 'Xanthohumol metabolites in blood, urine, and stool']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",,0.329114,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'National University of Natural Medicine, Portland, USA. rbradley@nunm.edu.'}, {'ForeName': 'Blake O', 'Initials': 'BO', 'LastName': 'Langley', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phipps', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stack', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Jansson', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Metz', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Jan Frederik', 'Initials': 'JF', 'LastName': 'Stevens', 'Affiliation': 'Oregon State University, Corvallis, USA.'}]",Trials,['10.1186/s13063-020-04769-2']
3129,33028623,Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).,"OBJECTIVE


To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.
METHODS


Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.
RESULTS


171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
CONCLUSIONS


Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.",2020,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","['Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy', '171 patients', 'advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load', 'Patients with high tumor load assessed by a standardized laparoscopic predictive index']","['primary debulking surgery', 'primary debulking surgery versus neoadjuvant chemotherapy', 'primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B', 'neoadjuvant chemotherapy followed by interval debulking surgery', 'neoadjuvant chemotherapy']","['progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life', 'Median progression-free and overall survival', 'disease progressions/recurrences and 103 deaths', 'toxicity profile', 'advanced epithelial ovarian cancer', '53 major postoperative complications', 'Rates of complete resection (R0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",171.0,0.400373,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy annafagotti70@gmail.com.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ferrandina', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vizzielli', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Statistics Technology Archiving Research (STAR) Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gallotta', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Pasquale Alessandro', 'Initials': 'PA', 'LastName': 'Margariti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Chiantera', 'Affiliation': 'Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Costantini', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Gynecologic Oncology, Gemelli Molise spa, Università Cattolica del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001640']
3130,33029804,Single- or double-layer uterine closure techniques following cesarean: A randomized trial.,"INTRODUCTION


Cesarean deliveries are commonly performed throughout the world. Although the uterine closure technique following this procedure may influence how the uterine scar heals, there is insufficient evidence for choosing the appropriate technique and so preventing long-term negative consequences. This prospective, randomized study examined the effects of single- and double-layer uterine closure techniques on uterine scar healing following cesarean delivery.
MATERIAL AND METHODS


This study assessed a total of 282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies. None had previously undergone uterine surgeries. These participants completed their first cesarean deliveries at the time of study and were randomized into the following two treatment groups: single-layer closure with locking and double-layer closure with locking in the first layer, but not in the second layer (NCT03629028). However, the decidua was not included for treatment in either group. Participants were evaluated at 6-9 months after cesarean section by saline infusion sonohysterography to assess cesarean delivery scar defects. These procedures were conducted by experienced sonographers who were not aware of the uterine closure technique.
RESULTS


Of the 225 final participants, 109 received the single-layer closure technique, whereas 116 received the double-layer technique. The niche rates were 37% (n = 40) for the single-layer group and 45.7% (n = 53) for the double-layer group (P = .22, relative risk 1.4, 95% CI = 0.8-4.4).
CONCLUSIONS


The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.",2020,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"['Of the 225 final participants', 'cesarean', '282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies', 'participants completed their first cesarean deliveries at the time of study']","['single- and double-layer uterine closure techniques', 'Single or double-layer uterine closure techniques', 'single-layer closure with locking and double-layer closure with locking']","['uterine-scar healing', 'niche rates', 'cesarean delivery scar defects']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",282.0,0.192183,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"[{'ForeName': 'Şafak', 'Initials': 'Ş', 'LastName': 'Yılmaz Baran', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kalaycı', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Gülşen', 'Initials': 'G', 'LastName': 'Doğan Durdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Yetkinel', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Alemdaroğlu', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Çok', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Bulgan Kılıçdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14018']
3131,33034421,"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","INTRODUCTION


Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.
METHODS


UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring ®  (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.
RESULTS


Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring ®  users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring ®  , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.
CONCLUSIONS


Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.",2020,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"['Young women in Southern Africa', 'HIV prevention in youth', 'female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose', '180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n\xa0=\xa045), injection (n\xa0=\xa045) or', 'healthy, HIV-uninfected, female adolescents aged 15 to 19\xa0years, as a proxy for similar HIV prevention methods', 'adolescent girls and young women']","['COC', 'bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC']","['acceptability and preference', 'changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods', 'contraceptive acceptability and preference']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",130.0,0.0785338,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Strode', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fynn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Cancer Association of South Africa, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Smit', 'Affiliation': 'MSD (Pty) Ltd, Halfway House, South Africa.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25626']
3132,33031270,"Contrast-enhanced ultrasound for determining muscular perfusion after oral intake of L-citrulline, L-arginine, and galloylated epicatechines: A study protocol.","INTRODUCTION


The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called ""NO-boosters,"" which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS).
METHODS


This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters.
DISCUSSION


The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.",2020,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","['30-male athletes between 18 and 40 years', 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg', 'healthy male athletes']","['muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS', 'nitric oxide', 'Contrast-enhanced ultrasound', 'placebo']",['muscular perfusion'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.227635,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bürkle', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Neide', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Tsitlakidis', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}]",Medicine,['10.1097/MD.0000000000022318']
3133,33031287,Clinical application of accelerated rehabilitation surgery in elderly patients with colorectal cancer.,"BACKGROUND


Gastrointestinal malignant tumors are the most common malignant tumors in elderly people in China, resulting in an increasing trend of morbidity and mortality. We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
METHODS


This is a single center, non-random, parallel-controlled clinical trial, 60 patients aged ≥65 years will be randomized for Case group ERAS and Control group (routine care).
RESULTS


This study will help to evaluate the clinical feasibility, safety and effectiveness of ERAS in elderly patients undergoing colorectal resection compared with routine care.
PROTOCOL REGISTRATION NUMBER


ChiCTR2000034984.",2020,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","['elderly patients with colorectal cancer', 'elderly patients after colorectal cancer surgery', 'elderly patients undergoing colorectal resection compared with routine care', '60 patients aged ≥65 years']","['ERAS', 'Routine care', 'enhanced recovery after surgery (ERAS', 'accelerated rehabilitation surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],60.0,0.156973,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","[{'ForeName': 'Linxia', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery (Gastrointestinal Surgery), Hospital of Southwest Medical University, Jiangyang District, Luzhou City, Sichuan Province, China.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Meixuan', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xunlian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022503']
3134,33031293,The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial.,"BACKGROUND


There is no consensus in existing literature on the pulse power, application time, frequency and the dose of energy of laser therapy for the patients. Therefore, we conducted this research for the assessment of safety and efficiency of ultrasound and high-intensity laser therapy (HILT) in the lumbar disc herniation (LDH) patients.
METHODS


Our present research was approved by the institutional review board in the West China-Guangan Hospital. All the participants would acquire the written informed consent. From December 2020 to December 2021, we will conduct a prospective evaluation via a senior surgeon for 1 hundred LDH patients who plan to undergo the conservative treatment at our hospital. In this research, the inclusion criteria contained: the patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities; and the patients with sufficient psychological ability to understand and then answer the questions raised in assessment scale. The participants were randomly divided into the control group or HILT group after performing the examination of baseline. The main outcome was the pain score of visual analog scale. The other results contained the adverse effects, back range of motion as well as functional scores.
CONCLUSIONS


We assumed that the HILT is as effective as the ultrasound therapy in treating pain for LDH.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5975).",2020,"The other results contained the adverse effects, back range of motion as well as functional scores.
","['1 hundred LDH patients who plan to undergo the conservative treatment at our hospital', 'lumbar disc herniation (LDH) patients', 'patients with lumbar disc herniation', 'patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities']","['high intensity laser therapy', 'ultrasound and high-intensity laser therapy (HILT', 'HILT', 'placebo', 'control group or HILT']","['adverse effects, back range of motion as well as functional scores', 'pain score of visual analog scale']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0616658,"The other results contained the adverse effects, back range of motion as well as functional scores.
","[{'ForeName': 'Youyi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, Nanchang University, Jiangxi.'}, {'ForeName': 'Daxin', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, West China-Guangan Hospital, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022520']
3135,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES


We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS


Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS


We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2  = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2  = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS


Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
3136,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE


To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS


We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS


The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION


To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
3137,33051975,Tripeptide and hexapeptide topical as adjunct to nonablative fractional resurfacing for photodamage: A randomized split-face trial.,"BACKGROUND


Topical adjuncts have been investigated to improve clinical outcomes associated with laser resurfacing for photodamage and cutaneous aging. One such product is a tripeptide/hexapeptide serum, which has been shown to increase dermal collagen and elastin as well as improve postprocedural recovery following treatments.
AIMS


A randomized, blinded, split-face, comparative trial was performed to assess the utility of a tripeptide/hexapeptide serum as a peri-procedural adjunct to nonablative fractional laser resurfacing.
PATIENTS/METHODS


A total of 20 subjects were enrolled. Each hemiface was randomized to either tripeptide/hexapeptide serum or bland moisturizer for twice daily application starting 14 days prior to first laser treatment and continuing until 60 days after. All subjects received 2 treatments to entire face approximately 1 month apart with 1927 nm thulium nonablative fractional laser. Clinical measures and immediate postprocedural recovery were assessed.
RESULTS


For each hemiface, scores improved for all measures, including global photodamage, lentigines, pores, radiance, texture, and tone at 30 and 60 days. The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal. In cases where clinical ratings differed between sides, tripeptide/hexapeptide serum more frequently had the superior outcome. Overall, subjects were satisfied with tripeptide/hexapeptide serum. No significant adverse events were observed.
CONCLUSION


Addition of tripeptide/hexapeptide serum as a peri-procedural adjunct to nonablative fractional laser resurfacing improved various clinical measures of photodamage and cutaneous aging and the immediate postprocedural recovery. The tripeptide/hexapeptide serum was demonstrated to be safe, well-tolerated, and well-liked by subjects.",2020,"The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal.","['A total of 20 subjects were enrolled', 'photodamage']","['laser resurfacing', 'Tripeptide and hexapeptide topical', 'tripeptide/hexapeptide serum or bland moisturizer', 'tripeptide/hexapeptide serum', '1927nm thulium non-ablative fractional laser']","['adverse events', 'global photodamage, lentigines, pores, radiance, texture, and tone']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023321', 'cui_str': 'Lentigo'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]",20.0,0.0276005,"The tripeptide/hexapeptide serum had greater improvements for all measures at both time points, except for radiance at 60 days, which was equal.","[{'ForeName': 'Jordan V', 'Initials': 'JV', 'LastName': 'Wang', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Mitalee P', 'Initials': 'MP', 'LastName': 'Christman', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Ferzli', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Jeon', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Geronemus', 'Affiliation': 'Laser & Skin Surgery Center of New York, New York, NY, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13795']
3138,33035593,Functional and cognitive responses to caffeine intake in middle-aged women are dose depending.,"Middle-aged women display many physiological and cognitive alterations resulting from aging and physical inactivity as well as other changes that occur as a function of menopause. Caffeine consumption is highest in this age with women having a particular greater sensitivity to caffeine than men. Its effects on functional and cognitive functions are controversial and seem to depend on the dose intake. This study aimed to assess the effect of low (100mg) and high (400mg) doses of caffeine consumption on cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances. These performances were evaluated in 19 healthy middle-aged women by the 30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo). Low caffeine consumption significantly improved (p<.005) cognitive performance, while high caffeine consumption did not. However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption. Except, the functional mobility performance significantly improved (p<.05) after both low and high caffeine consumption with better improvement (p<.05) after the high dose. In conclusion, low caffeine consumption improved cognitive performance and high caffeine consumption improved functional performance but the functional mobility improved after both low and high caffeine consumption in middleaged women.",2020,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","['middleaged women', '19 healthy middle-aged women by the', 'middle-aged women', 'Middle-aged women']","['caffeine consumption', '30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo']","['Low caffeine consumption significantly improved (p<.005) cognitive performance', 'cognitive performance', 'Functional and cognitive responses', 'cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances', 'functional mobility performance', 'Caffeine consumption', 'functional performance', 'functional mobility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",19.0,0.026942,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","[{'ForeName': 'Fatma Ben', 'Initials': 'FB', 'LastName': 'Waer', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia. Electronic address: fatmaelwaer123@gmail.com.'}, {'ForeName': 'Rabeb', 'Initials': 'R', 'LastName': 'Laatar', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Jouira', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Srihi', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112956']
3139,33049909,Effect of Family-Based REDUCE Intervention Program on Children Eating Behavior and Dietary Intake: Randomized Controlled Field Trial.,"The objective of this study was to evaluate the effect of a family-based intervention program (REDUCE) on children's eating behaviors and dietary intake. A two-arm randomized controlled field trial was conducted among parents and children of 7 to 10 years old who were either overweight or obese. The intervention was conducted via face-to-face sessions and social media. The child eating behaviors were assessed using the child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks was assessed using a parental report of three days unweighted food. The generalized linear mixed modelling adjusted for covariates was used to estimate the intervention effects with alpha of 0.05. A total of 122 parents (91% response rate) completed this study. At the six-month post-training, there were statistically significant mean differences in the enjoyment of food (F(6481) = 4.653,  p  < 0.001), fruit and vegetable intake (F(6480) = 4.165,  p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful. This study added to the body of knowledge of family-based intervention that utilized social media and assessed the effect in children's eating behavior using the CEBQ and children's dietary intake.",2020,"p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[""children's eating behaviors and dietary intake"", '122 parents (91% response rate) completed this study', ""children's eating behavior using the CEBQ and children's dietary intake"", 'parents and children of 7 to 10 years old who were either overweight or obese', 'Children Eating Behavior and Dietary Intake']","['Family-Based REDUCE Intervention Program', 'family-based intervention program (REDUCE']","['child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks', 'child eating behaviors', 'unhealthy snack intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",122.0,0.0364819,"p  < 0.001) and unhealthy snack intake (F(6480) = 5.062,  p  < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[{'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zalilah Mohd', 'Initials': 'ZM', 'LastName': 'Shariff', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}]",Nutrients,['10.3390/nu12103065']
3140,33050115,Attention Networks in ADHD Adults after Working Memory Training with a Dual  n -Back Task.,"Patients affected by Attention-Deficit/Hyperactivity Disorder (ADHD) are characterized by impaired executive functioning and/or attention deficits. Our study aim is to determine whether the outcomes measured by the Attention Network Task (ANT), i.e., the reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects are affected by cognitive training with a Dual  n -back task. We considered three groups of young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls. Working memory training consisted of a daily practice of 20 blocks of Dual  n -back task (approximately 30 min per day) for 20 days within one month. Participants of each group were randomly assigned into two subgroups, the first one with an adaptive mode of difficulty ( adaptive  training), while the second was blocked at the level 1 during the whole training phase (1-back task,  baseline  training). Alerting and orienting effects were not modified by working memory training. The dimensional analysis showed that after  baseline  training, the lesser the severity of the hyperactive-impulsive symptoms, the larger the improvement of reaction times on trials with high executive control/conflict demand (i.e., what is called  Conflict Effect ), irrespective of the participants' group. In the categorical analysis, we observed the improvement in such  Conflict Effect  after the  adaptive  training in adult ADHD patients irrespective of their medication, but not in controls. The ex-Gaussian analysis of RT and RT variability showed that the improvement in the  Conflict Effect  correlated with a decrease in the proportion of extreme slow responses. The Dual  n -back task in the  adaptive  mode offers as a promising candidate for a cognitive remediation of adult ADHD patients without pharmaceutical medication.",2020,Alerting and orienting effects were not modified by working memory training.,"['adult ADHD patients without pharmaceutical medication', 'young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls', 'ADHD Adults after Working Memory Training with a Dual  n -Back Task']","['cognitive training with a Dual  n -back task', 'adaptive mode of difficulty ( adaptive  training), while the second was blocked at the level 1 during the whole training phase (1-back task,  baseline  training']","['proportion of extreme slow responses', 'severity of the hyperactive-impulsive symptoms', 'reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0316141,Alerting and orienting effects were not modified by working memory training.,"[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Dotare', 'Affiliation': 'School of Medicine, Yamaguchi University, 1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bader', 'Affiliation': 'Department of Psychiatry -SUPEA, University Hospital of Lausanne, CH-1004 Lausanne, Switzerland.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Mesrobian', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Asai', 'Affiliation': 'Department of Systems Bioinformatics, Graduate School of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Alessandro E P', 'Initials': 'AEP', 'LastName': 'Villa', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lintas', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}]",Brain sciences,['10.3390/brainsci10100715']
3141,33050169,Acute Effects of Metformin and Vildagliptin after a Lipid-Rich Meal on Postprandial Microvascular Reactivity in Patients with Type 2 Diabetes and Obesity: A Randomized Trial.,"BACKGROUND


Type 2 diabetes mellitus and obesity are both related to endothelial dysfunction. Postprandial lipemia is a cardiovascular risk. Notably, it is known that a high-fat diet may elicit microvascular dysfunction, even in healthy subjects. Since anti-diabetic drugs have different mechanisms of action and also distinct vascular benefits, we aimed to compare the results of two anti-diabetic drugs after the intake of a lipid-rich meal on microcirculation in patients with type 2 diabetes and obesity. In parallel, we also investigated the metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides.
SUBJECTS/METHODS


We included 38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 . We performed endothelial measurements and collected samples before (fasting) and after the intake of a lipid-rich meal at 30, 60, 120, and 180 min. Patients were randomized to metformin or vildagliptin, given orally just before the meal. Endothelial function was assessed by videocapillaroscopy and laser-Doppler flowmetry to investigate microvascular reactivity. Besides, we also investigated plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile in all time points.
RESULTS


No differences at baseline were noted between groups. Vildagliptin increased glucagon-like peptide-1 compared to metformin. Paired comparisons showed that, during the postprandial period, vildagliptin significantly changed levels of insulin and glucagon-like peptide-1, and also the dipeptidyl peptidase-4 activity, while metformin had effects on plasma glucose solely. Metformin use during the test meal promoted an increase in functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged.
CONCLUSIONS


After the intake of a lipid-rich meal, the use of vildagliptin preserved postprandial non-nutritive microflow and vasomotion, while metformin increased capillary recruitment, suggesting protective and different mechanisms of action on microcirculation.",2020,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"['Patients with Type 2 Diabetes and Obesity', '38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 ', 'patients with type 2 diabetes and obesity', 'healthy subjects']","['vildagliptin', 'Vildagliptin', 'metformin or vildagliptin', 'metformin', 'Metformin and Vildagliptin', 'lipid-rich meal', 'videocapillaroscopy and laser-Doppler flowmetry', 'Lipid-Rich Meal', 'Metformin']","['plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile', 'metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides', 'Postprandial Microvascular Reactivity', 'functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged', 'plasma glucose solely', 'Endothelial function', 'levels of insulin and glucagon-like peptide-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3652744', 'cui_str': 'metformin and vildagliptin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4045986', 'cui_str': 'Videocapillaroscopy'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0239451,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Schiappacassa', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Priscila A', 'Initials': 'PA', 'LastName': 'Maranhão', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Maria das Graças Coelho de', 'Initials': 'MDGC', 'LastName': 'Souza', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Diogo G', 'Initials': 'DG', 'LastName': 'Panazzolo', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'José Firmino', 'Initials': 'JF', 'LastName': 'Nogueira Neto', 'Affiliation': 'Lipids Laboratory (Lablip), Policlínica Piquet Carneiro, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-003, Brazil.'}, {'ForeName': 'Eliete', 'Initials': 'E', 'LastName': 'Bouskela', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Luiz Guilherme', 'Initials': 'LG', 'LastName': 'Kraemer-Aguiar', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}]",Journal of clinical medicine,['10.3390/jcm9103228']
3142,33050179,Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care.,"Female family caregivers (FFCs) constitute one of the basic supports of socio-health care for dependence in developed countries. The care provided by FFCs may impact their physical and mental health, negatively affecting their quality of life. In order to alleviate the consequences of providing care on FFCs, the Spanish Public Health System has developed the family caregiver care programme (FCCP) to be applied in primary care (PC) centres. The effectiveness of this programme is limited. To date, the addition of a physical therapeutic exercise (PTE) programme to FCCP has not been evaluated. A randomised multicentre clinical trial was carried out in two PC centres of the Spanish Public Health System. In total, 68 FFCs were recruited. The experimental group (EG) performed the usual FCCP (4 sessions, 6 h) added to a PTE programme (36 sessions in 12 weeks) whereas the control group performed the usual FCCP performed in PC. The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance). Differences between the groups ( p  < 0.05) were clinically relevant in favour of the EG. The experimental treatment generates high levels of satisfaction.",2020,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","['Caregivers of Dependent Patients', 'two PC centres of the Spanish Public Health System', 'In total, 68 FFCs were recruited', 'Female family caregivers (FFCs']","['physical therapeutic exercise (PTE) programme', 'usual FCCP (4 sessions, 6 h) added to a PTE programme', 'usual FCCP performed in PC', 'Physical Therapeutic Exercise Programme']","['health-related physical condition', 'quality of life', 'subjective burden', 'anxiety']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0437757,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Montero-Cuadrado', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Martín', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Physical Activity and Sports Sciences, University Pontificia of Salamanca, 37002 Salamanca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Mayo-Iscar', 'Affiliation': 'Department of Statistics and Operational Research and IMUVA, University of Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Ántonio', 'Initials': 'Á', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy, Faculty of Heath Sciences, University of Malaga, 19071 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207359']
3143,33050340,Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke.,"Transcranial direct current stimulation (tDCS) has strong potential for outpatient clinical use, but feasibility and safety of tDCS has only been evaluated in laboratory and inpatient clinical settings. The objective of this study was to assess feasibility and safety of tDCS for stroke in an outpatient clinical setting. Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions. Feasibility was assessed with screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS. Acute changes in fatigue and self-reported function and pre-post changes in fatigue were also assessed. Safety was assessed as adverse events and side effects. In total, 85 individuals were screened, and 10 were enrolled. Most exclusions were unrelated to clinical feasibility. In total, 3 participants withdrew, so 7 participants completed 2 sessions/week for 5-6 weeks with 100% adherence. In total, 71% reported positive impressions of tDCS. tDCS setup decreased to 5-7 min at end of study. There was one adverse event unrelated to tDCS. Mild to moderate side effects (tingling, itching, pinching, and fatigue) were experienced. In total, 86% of participants recounted benefits of tDCS. There were acute improvements in function and energy. Results support the feasibility and safety of tDCS in an outpatient clinical setting.",2020,There was one adverse event unrelated to tDCS.,"['Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions', '85 individuals were screened, and 10 were enrolled', 'Outpatient Rehabilitation Setting After Stroke']","['Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'tDCS']","['screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS', 'positive impressions of tDCS', 'tDCS setup', 'Mild to moderate side effects (tingling, itching, pinching, and fatigue', 'fatigue and self-reported function and pre-post changes in fatigue', 'feasibility and safety', 'function and energy', 'adverse events and side effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0441035,There was one adverse event unrelated to tDCS.,"[{'ForeName': 'Brice T', 'Initials': 'BT', 'LastName': 'Cleland', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Galick', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Huckstep', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenhart', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Brain sciences,['10.3390/brainsci10100719']
3144,33050362,"Effects of Hyperbaric Oxygen Therapy on Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage after Acute Exercise in Normobaric, Normoxic and Hypobaric, Hypoxic Environments: A Pilot Study.","The purpose of this study was to investigate the effects of hyperbaric oxygen therapy (HBOT) on inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments. Eighteen healthy males were selected and randomly assigned to three groups: exercise in NN conditions (NN group,  n  = 6), HBOT treatment after exercise in NN conditions (HNN group,  n  = 6), and HBOT treatment after exercise in HH conditions (HHH group,  n  = 6). All subjects performed treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition. The HBOT treatments consisted of breathing 100% oxygen at 2.5 atmosphere absolute (ATA) for 60 min. Blood samples were collected before exercise (BE), after exercise (AE), and after HBOT (AH) to examine inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH)). Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05). Plasma fibrinogen levels were significantly decreased AH compared to AE in all groups ( p  < 0.05), and the HNN group had a significantly lower AH compared to BE ( p  < 0.05). Serum IL-6 levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p  < 0.05). Serum CK levels were significantly decreased AH compared to AE in the HHH group ( p  < 0.05). Serum LDH levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p  < 0.05), and the NN and HNN groups had significantly higher AH serum LDH levels compared to BE ( p  < 0.05). These results suggest that acute exercise in both the NN and HH environments could induce temporary inflammatory responses and muscle damage, whereas HBOT treatment may be effective in alleviating exercise-induced inflammatory responses and muscle damage.",2020,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05).",['Eighteen healthy males'],"['exercise in NN conditions (NN group,  n  = 6), HBOT treatment after exercise in NN conditions (HNN group,  n  = 6), and HBOT treatment after exercise in HH conditions (HHH group,  n  = 6', 'Hyperbaric Oxygen Therapy', 'treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition', 'hyperbaric oxygen therapy (HBOT']","['Serum IL-6 levels', 'AH serum LDH levels', 'Plasma fibrinogen, serum IL-6, CK, and LDH levels', 'Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage', 'inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments', 'Serum LDH levels', 'inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH', 'Serum CK levels', 'Plasma fibrinogen levels']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0268540', 'cui_str': 'Hyperornithinemia-hyperammonemia-homocitrullinuria syndrome'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",18.0,0.0181581,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p  < 0.05).","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Jae-Hee', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Yul-Hyo', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207377']
3145,31253454,Fostering Effective Asthma Self-Management Transfer in High-Risk Children: Gaps and Opportunities for Family Engagement.,"INTRODUCTION


The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
METHOD


Fifteen mothers of children with uncontrolled asthma participated in semistructured interviews exploring the transfer of asthma self-management responsibilities from parent to child. Team members performed thematic analysis of written transcripts.
RESULTS


All participants were all the biological mothers and were impoverished, with most (73%) reporting an annual family income of less than $30,000. Their children ranged from 5 to 15 years old, were African American (100%), and had uncontrolled asthma based on national guidelines. Themes showed that child asthma self-management is difficult to achieve, that the transfer of asthma responsibility from mother to child is variable, and that mothers overestimate their child's developmental capacities for independent asthma self-management and have poor understanding of what well-controlled asthma means.
DISCUSSION


Ongoing assessment and tailored guidance from health care providers are critical to support the pivotal role of mothers in their child's self-management development process.",2019,"The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
","['High-Risk Children', 'Fifteen mothers of children with uncontrolled asthma participated in semistructured interviews exploring the transfer of asthma self-management responsibilities from parent to child', 'All participants were all the biological mothers and were impoverished, with most (73%) reporting an annual family income of less than $30,000', 'Their children ranged from 5 to 15 years old, were African American (100%), and had uncontrolled asthma based on national guidelines', 'children with asthma from families with low income']",[],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337486', 'cui_str': 'Natural mother'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],[],,0.0124432,"The process of self-management knowledge, behavior, and skill development in children with asthma from families with low income is understudied.
","[{'ForeName': 'Rachel H F', 'Initials': 'RHF', 'LastName': 'Margolis', 'Affiliation': ''}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Bellin', 'Affiliation': ''}, {'ForeName': 'Jaclyn R MacFarlane', 'Initials': 'JRM', 'LastName': 'Bookman', 'Affiliation': ''}, {'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Bollinger', 'Affiliation': ''}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Lewis-Land', 'Affiliation': ''}, {'ForeName': 'Arlene M', 'Initials': 'AM', 'LastName': 'Butz', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2019.05.004']
3146,33030151,Career Crafting Training Intervention for Physicians: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Physicians work in a highly demanding work setting where ongoing changes affect their work and challenge their employability (ie, their ability and willingness to continue working). In this high-pressure environment, physicians could benefit from proactively managing or crafting their careers; however, they tend not to show this behavior. The new concept of career crafting concerns proactively making choices and adapting behavior regarding both short-term job design (ie, job crafting) as well as longer-term career development (ie, career self-management). However, so far, no intervention studies have aimed at enhancing career crafting behavior among physicians. Given that proactive work and career behavior have been shown to be related to favorable outcomes, we designed an intervention to support career crafting behavior and employability of physicians.
OBJECTIVE


The objectives of this study were to describe (1) the development and (2) the design of the evaluation of a randomized controlled career crafting intervention to increase job crafting, career self-management, and employability.
METHODS


A randomized controlled intervention study was designed for 141 physicians in two Dutch hospitals. The study was designed and will be evaluated based on parts of the intervention mapping protocol. First, needs of physicians were assessed through 40 interviews held with physicians and managers. This pointed to a need to support physicians in becoming more proactive regarding their careers as well as in building awareness of proactive behaviors in order to craft their current work situation. Based on this, a training program was developed in line with their needs. A number of theoretical methods and practical applications were selected as the building blocks of the training. Next, participants were randomly assigned to either the waitlist-control group (ie, received no training) or the intervention group. The intervention group participated in a 4-hour training session and worked on four self-set goals. Then, a coaching conversation took place over the phone. Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance. In addition, a process evaluation was conducted to examine factors that may have promoted or hindered the effectiveness of the intervention.
RESULTS


Data collection was completed in March 2020. Evaluation of outcomes and the research process started in April 2020. Study results were submitted for publication in September 2020.
CONCLUSIONS


This study protocol gives insight into the systematic development and design of a career crafting training intervention that is aimed to enhance job crafting, career self-management, and employability. This study will provide valuable information to physicians, managers, policy makers, and other researchers that aim to enhance career crafting.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18432.",2020,"Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance.",['141 physicians in two Dutch hospitals'],"['4-hour training session and worked on four self-set goals', 'waitlist-control group (ie, received no training', 'Career Crafting Training Intervention']","['changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0351807,"Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance.","[{'ForeName': 'Evelien H', 'Initials': 'EH', 'LastName': 'van Leeuwen', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Work and Organizational Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Knies', 'Affiliation': 'Utrecht University School of Governance, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Toon W', 'Initials': 'TW', 'LastName': 'Taris', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, Netherlands.'}]",JMIR research protocols,['10.2196/18432']
3147,33032546,Improving infant sleep safety via electronic health record communication: a randomized controlled trial.,"BACKGROUND


With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines.
METHODS


One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher's Exact test to assess group differences in guideline adherence at 2 months.
RESULTS


One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25-52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface.
CONCLUSIONS


Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices.
TRIAL REGISTRATION


Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None.",2020,"Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75).","['One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention', 'One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery']","['electronic health record communication', 'personalized feedback', 'electronic health record patient portals to transmit photographs']","['feasibility and efficacy', 'Standardized feedback', 'safe sleep criteria']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",,0.220848,"Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75).","[{'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Canty', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Fogel', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Erich K', 'Initials': 'EK', 'LastName': 'Batra', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Beiler', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA. ipaul@psu.edu.'}]",BMC pediatrics,['10.1186/s12887-020-02369-2']
3148,33031636,Comparative evaluation of efficacy of enzymatic toothpaste over standard fluoridated toothpaste in reduction of plaque and gingivitis.,"OBJECTIVES


To compare and evaluate the efficacy of enzymatic toothpaste v/s standard fluoridated toothpaste in reduction of plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT).
MATERIALS AND METHODS


A total of 52 participants belonging to age 20-50 years eligible for inclusion were randomly chosen from the outpatient department. Computer-generated randomization was followed to recruit the subjects into two groups. 26 subjects were assigned to control group who were given with control toothpaste (standard fluoridated toothpaste), while 26 subjects were assigned to test group (enzymatic toothpaste) and given with test toothpaste. The amount of dental plaque and gingivitis were assessed baseline visit and at 6-week follow-up visit using Turesky-Gilmore-Glickman modification of the Quigley-Hein plaque index (TQHPI) 1970, Gingival Index (GI) - (Löe and Sillness 1963) and Full Mouth Bleeding Score (FMBS), respectively. Data analysis was done using IBM SPSS ®  version 22.
RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow-up visit. (p = 0.006*, p = 0.001*, p = 0.001*, respectively).
CONCLUSIONS


Within the limitations of our study, it can be concluded that test toothpaste has shown to be efficient than the previously set standard control fluoridated toothpaste in terms of reduction of plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT).",2020,"RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow up visit.","['26 subjects', 'plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT', '52 participants belonging to age 20-50 years eligible for inclusion were randomly chosen from the outpatient department']","['test group (Enzymatic toothpaste) and given with test toothpaste', 'enzymatic toothpaste over standard fluoridated toothpaste', 'control toothpaste (Standard fluoridated toothpaste', 'enzymatic toothpaste v/s standard fluoridated toothpaste']","['Quigley-Hein plaque index (TQHPI) 1970, Gingival Index (GI) ', 'TQHPI, GI and FMBS', 'reduction of plaque and gingivitis', 'amount of dental plaque and gingivitis', 'Full Mouth Bleeding Score (FMBS']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0217445,"RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow up visit.","[{'ForeName': 'Ashwin Parakkaje', 'Initials': 'AP', 'LastName': 'Subramanya', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Prabhuji', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India.'}, {'ForeName': 'Karthikeyan Bangalore', 'Initials': 'KB', 'LastName': 'Vardhan', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India.'}, {'ForeName': 'Prabhuji', 'Initials': 'P', 'LastName': 'Mlv', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India.'}]",International journal of dental hygiene,['10.1111/idh.12476']
3149,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE


Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN


A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING


52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP


304 US-trained practicing anesthesiologists.
INTERVENTIONS


The absence or presence of the EM during the simulation case.
MEASUREMENTS


Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS


Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS


Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
3150,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE


The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN


Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS


For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION


The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
3151,33034564,Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.,"BACKGROUND


Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.
OBJECTIVE


We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.
METHODS


In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.
RESULTS


Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).
CONCLUSIONS


Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.",2020,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","['Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with', '160 participants participated in the baseline screening examination', 'Community-Dwelling Population With Moderate Metabolic Abnormalities', 'participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level', 'adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting', 'Between October 28, 2017 and May 28, 2018']","['Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching', 'smartphone-based weight management app', 'Smartphone-Based Lifestyle Coaching App', 'block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching', 'personalized coaching']","['body weight reductions', 'diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level', 'systolic blood pressure', 'metabolic parameters']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",160.0,0.120663,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","[{'ForeName': 'So Mi Jemma', 'Initials': 'SMJ', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Shim', 'Affiliation': 'Cardiovascular and Metabolic Diseases Etiology Research Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyungseon', 'Initials': 'H', 'LastName': 'Yeom', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'Jeon', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeon Chang', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/17435']
3152,33034565,Evaluating the Implementation of a Remote-Monitoring Program for Chronic Obstructive Pulmonary Disease: Qualitative Methods from a Service Design Perspective.,"BACKGROUND


Implementing digital health technologies is complex but can be facilitated by considering the features of the tool that is being implemented, the team that will use it, and the routines that will be affected.
OBJECTIVE


The goal of this study was to assess the implementation of a remote-monitoring initiative for patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework and to refine this approach to conceptualize the adoption of technologies in health care.
METHODS


This study was a qualitative research project that took place alongside a randomized controlled trial comparing a technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program in patients with chronic obstructive pulmonary disease and with standard care. This study included interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators. The interview questions were structured around the 3 main concepts of the Tool+Team+Routine framework.
RESULTS


Findings emphasized that (1) technologies can alter relationships between providers and patients, and that these relationships drove the development of a new service arising from the technology, in our case, and (2) technologies can create additional work that is not visible to management as a result of not being considered within the scope of the service.
CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies. By acknowledging the centrality of such relationships, implementation teams can better plan for the adaptations required in order to make new technologies work for patients and health care providers. Further work will need to address how specific individuals administering a remote-monitoring program work to build relationships, and how these relationships and other sources of activity might lead to technological scope creep-an unanticipated expanding scope of work activities in relation to the function of the tool.",2020,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","['Chronic Obstructive Pulmonary Disease', 'patients and health care providers', 'patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework', 'patients with chronic obstructive pulmonary disease and with standard care', 'interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators']","['Remote-Monitoring Program', 'technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0019949', 'cui_str': 'Hospital administrator'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],5.0,0.0261161,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'van Lieshout', 'Affiliation': 'University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Vess', 'Initials': 'V', 'LastName': 'Stamenova', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cornejo Palma', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sidhu', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Erwood', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharyya', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/18148']
3153,33035186,Neutral douche: a hydrotherapeutic tool to manage pain and systemic symptoms in primary dysmenorrhea - a randomised controlled study.,"Background & Objectives The douche, one of the hydrotherapeutic treatment modality is commonly used by Naturopathy physicians as a treatment of choice in the management of several ailments. This study was done to assess the effect of full body neutral douche in the management of pain and systemic symptoms in adult females with primary dysmenorrhoea. Methods 68 subjects of age 18-22 years with primary dysmenorrhoea were recruited for the study and were randomly divided into two groups: the experimental group (n = 34) and the control group (n = 34). The experimental group received whole body neutral douche, whereas the control group followed the routine as usual. Assessments for the pain, systemic symptoms and menstrual cramps were done by using McGill Pain Questionnaire, Verbal multidimensional scoring system and analog scale for severity of pain and menstrual cramps respectively at baseline, day 30 and day 60 of intervention. Two- way repeated measures of ANOVA was performed to understand the between group changes, adjusted for the respective baseline values and age. Result Data was analyzed with SPSS (Version 21.0) package. Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?2 = 0.771], severity of pain [F(2,66) = 70.418, p < 0.0005, partial ?2 = 0.681], cramps [F(2,66) = 75.986, p < 0.0005, partial ?2 = 0.697] and systemic symptoms [F(2,66) = 14.64, p < 0.0005, partial ?2 = 0.307] as compared to the control group. Conclusion Findings suggest that neutral douche can be used as a non-pharmacological intervention in the management of pain and systemic symptoms in primary dysmenorrhea.",2020,"Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?","['adult females with primary dysmenorrhoea', '68 subjects of age 18-22 years with primary dysmenorrhoea', 'primary dysmenorrhea ']",['hydrotherapeutic tool'],"['pain and systemic symptoms', 'McGill Pain Questionnaire, Verbal multidimensional scoring system and analog scale for severity of pain and menstrual cramps', 'systemic symptoms', 'pain, systemic symptoms and menstrual cramps']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",68.0,0.0584242,"Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?","[{'ForeName': 'Sataz', 'Initials': 'S', 'LastName': 'Rahmania', 'Affiliation': ""Alva's College of Naturopathy and Yogic Sciences, Moodbidri, India.""}, {'ForeName': 'Vanitha', 'Initials': 'V', 'LastName': 'Shetty', 'Affiliation': ""Alva's College of Naturopathy and Yogic Sciences, Moodbidri, India.""}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ragavendrasamy', 'Affiliation': 'Government Hospital, Udumalpet, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0241']
3154,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
3155,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE


The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS


Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS


Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION


Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2020,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
3156,33036155,"Effects of the Daily Consumption of Stevia on Glucose Homeostasis, Body Weight, and Energy Intake: A Randomised Open-Label 12-Week Trial in Healthy Adults.","Stevia is a non-nutritive sweetener, providing sweet taste with no calories. This randomised, controlled, open-label 2-parallel arm trial examined the effects of daily stevia consumption on glycaemia in healthy adults. Secondary endpoints included body weight (BW) and energy intake (EI). Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ) were randomised into either the stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group ( n  = 14). At weeks 0 and 12, the glucose and insulin responses to an oral glucose tolerance test were measured; BW and EI were assessed at weeks 0, 6, and 12. There was no significant difference in the glucose or insulin responses. There was a significant main effect of group on BW change (F(1,26) = 5.56,  p  = 0.026), as the stevia group maintained their weight as opposed to the control group (mean weight change at week 12: -0.22 kg, 95%CI [-0.96, 0.51] stevia group, +0.89 kg, 95%CI [0.16, 1.63] control group). The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973). Although not placebo-controlled, these results suggest that daily stevia consumption does not affect glycaemia in healthy individuals, but could aid in weight maintenance and the moderation of EI.",2020,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","['Healthy Adults', 'healthy individuals', 'healthy adults', 'Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ']","['stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group', 'placebo', 'daily stevia consumption']","['body weight (BW) and energy intake (EI', 'energy intake', 'Glucose Homeostasis, Body Weight, and Energy Intake', 'glucose or insulin responses', 'glucose and insulin responses to an oral glucose tolerance test']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",28.0,0.0416548,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Crooks', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}]",Nutrients,['10.3390/nu12103049']
3157,33043591,Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen: A randomized double-blind trial.,"AIM


To assess the safety and efficacy of the short-acting glucagon-like peptide-1 receptor agonist exenatide on a population of patients with type 2 diabetes (T2D) mostly treated with continuous subcutaneous insulin injection (CSII).
MATERIALS AND METHODS


A phase 2/3, multicentre, randomized, parallel-group, double-blind, placebo-controlled, 6-month trial was conducted. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10 μg BID) or matched placebo.
RESULTS


A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n = 28) and placebo (n = 18). CSII treatment was used by 75% and 89% of patients of the exenatide and placebo groups, respectively. At 6 months, the change in HbA1c was -0.62% ± 0.94% and 0.08% ± 0.81% in the exenatide and placebo groups, respectively (difference, -0.70%; 95% CI [-1.24%; -0.15%], P = .014); body weight and body mass index decreased in the exenatide group (-2.55 ± 3.25 kg and -1.00 ± 1.31 kg/m 2  ) and increased in the placebo group (1.29 ± 2.82 kg and 0.46 ± 1.16 kg/m 2  ) (observed difference, -3.85 and -1.45, respectively, both P < .001); the postdinner capillary blood glucose value was lower in the exenatide group compared with the placebo group (162.4 ± 80.5 vs. 259.1 ± 94.4 mg/dL, respectively; observed difference, -96.7, P < .01). Hypoglycaemic risk, quality of life and overall safety were not different between the groups, apart from the expected occurrence of digestive effects in the exenatide group.
CONCLUSIONS


Although we failed to reach our planned sample size, the addition of exenatide treatment 10 μg BID SC in T2D patients with uncontrolled HbA1c despite an intensified insulin regimen, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance.",2020,"Hypoglycemic risk, quality of life and overall safety were not different between groups, apart from the expected occurrence of digestive effects in the exenatide group.
","['T2D patients mostly treated with continuous subcutaneous insulin injection (CSII', 'type 2 diabetes patients with intensive insulin regimen', '46 patients with T2D and elevated HbA1c']","['short-acting GLP-1RA exenatide', 'exenatide', 'Exenatide', 'subcutaneous (SC) injections of exenatide (10μg BID) or matched-placebo', 'exenatide and placebo', 'placebo']","['safety and efficacy', 'post-dinner capillary blood glucose value', 'body weight and BMI', 'HbA1c and body weight', 'Efficacy and safety', 'Hypoglycemic risk, quality of life and overall safety', 'digestive effects']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",46.0,0.620012,"Hypoglycemic risk, quality of life and overall safety were not different between groups, apart from the expected occurrence of digestive effects in the exenatide group.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joubert', 'Affiliation': 'Diabetes Care Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Opigez', 'Affiliation': 'Diabetes Care Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Pavlikova', 'Affiliation': 'First Department of Internal Medicine, Charles University Hospital in Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Peyro Saint Paul', 'Affiliation': 'Clinical Research Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': 'Diabetes Care Unit, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Anaïs R', 'Initials': 'AR', 'LastName': 'Briant', 'Affiliation': 'Clinical Research Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'Unicaen, Caen, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'Diabetes Care Unit, Caen University Hospital, Caen, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14225']
3158,33039647,Treatable Traits That Predict Health Status and Treatment Response in Airway Disease.,"BACKGROUND


A strategy based on the assessment and management of treatable traits (TTs) has been proposed as a new paradigm in airway disease. There is a potentially long list of TTs with likely different clinical impact.
OBJECTIVE


To identify TTs most strongly associated with poorer health-related quality of life (HRQOL) and treatments that most substantially improved HRQOL.
METHODS


We pooled data from 2 parallel-group clinical trials of multidimensional assessment and individualized management targeted to TTs versus usual care in patients with chronic obstructive pulmonary disease or severe asthma (intervention N = 45; control N = 46). Following multidimensional assessment, 22 TTs were identified and the intervention group received treatments tailored to their identified TT. We used Bayesian Model Averaging to examine associations between TTs and HRQOL (St George's Respiratory Questionnaire) at baseline, as well as between each TT treatment and the observed change in HRQOL postintervention.
RESULTS


TTs most substantially associated with poorer baseline HRQOL were frequent chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein >3 mg/L), and depression. In both trials, TT treatment led to a large, significant improvement in HRQOL compared with usual care (Cohen's d = 1.19; P < .001). Receiving a statin for systemic inflammation and oral corticosteroid for eosinophilic airway inflammation was associated with the largest HRQOL improvements. Treatments for exercise intolerance, anxiety, and obesity were associated with smaller improvements in HRQOL.
CONCLUSIONS


This study contributes to identifying clinically impactful TTs by showing that TTs across pulmonary, extrapulmonary, and behavioral domains were associated with HRQOL impairment and treatment response.",2020,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).",['patients with COPD or severe asthma (intervention N=45; control N=46'],['multidimensional assessment and individualised management targeted to TT versus usual care'],"['poorer health-related quality of life (HRQoL', 'chest infections, breathing pattern disorder, inadequate inhaler technique, systemic inflammation (C-reactive protein>3mg/L) and depression', 'HRQoL', ""TT and HRQoL (St George's Respiratory Questionnaire"", 'exercise intolerance, anxiety, and obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.164122,"In both trials, TT treatment led to a large, significant improvement in HRQoL compared with usual care (Cohen's d=1.19, p<0.001).","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hiles', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Alvar', 'Initials': 'A', 'LastName': 'Agusti', 'Affiliation': 'Respiratory Institute, Hospital Clinic, Universitat de Barcelona, IDIBAPS, CIBERES, Barcelona, Spain.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'Centre of Research Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, NSW, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, New Lambton Heights, NSW, Australia. Electronic address: vanessa.mcdonald@newcastle.edu.au.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.046']
3159,32861830,Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions-A prospective descriptive study.,"BACKGROUND


Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial.
METHODS


South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention.
RESULTS


Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
CONCLUSIONS


This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals 'at risk'.",2020,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","['Chronic viral hepatitis (CVH', 'South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with', 'Two hundred and nineteen first-generation migrants ≥18 years of age (53% female']","['hepatitis B and hepatitis C testing', 'dried blood spot CVH testing offered immediately afterwards', 'CVH testing']",[],"[{'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2711110', 'cui_str': 'Hepatitis B and hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",[],,0.0395415,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Pericleous', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': 'Department of Psychology, Kingston University, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hendy', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Shuja', 'Initials': 'S', 'LastName': 'Shafi', 'Affiliation': 'Research and Documentation Committee, The Muslim Council of Britain, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School and Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'Institute of Epidemiology and Health Care, UCL, London, UK.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Nicholls', 'Affiliation': 'Public Health England South East, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gore', 'Affiliation': 'The Hepatitis C Trust, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners Research and Surveillance Centre, London, UK.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ala', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: aftab.ala1@nhs.net.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.059']
3160,33045870,Comparison of two different shapes of stylets for intubation with the McGrath MAC® video laryngoscope: a randomized controlled trial.,"OBJECTIVE


This study was performed to compare two different shapes of stylets, 60° and J-shaped stylets, for intubation using the McGrath MAC® video laryngoscope (MVL).
METHODS


Two hundred twenty-two patients undergoing surgery under general anesthesia were randomly allocated to Group J (n = 111) or Group 60° (n = 111) and intubated using the MVL with the stylet bent into the allocated shape. The time to intubation (TTI) and other intubating profiles were compared between the groups. Multivariate regression analysis was used to determine the relationship between factors related to difficult intubation and TTI.
RESULTS


The TTI was not different between the two groups. There were also no differences in the intubating profiles between the two groups. In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50. In Group J, the TTI was longer with a body mass index (BMI) of ≥30 kg/m 2 .
CONCLUSION


The TTI during tracheal intubation with the MVL was not different between the two groups. The TTI was longer with an mMS of ≥3 and POGO score of <50. In Group J, the TTI was longer with a BMI of ≥30 kg/m 2 .",2020,"In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50.",['Two hundred twenty-two patients undergoing surgery under general anesthesia'],"['60° and J-shaped stylets, for intubation using the McGrath MAC® video laryngoscope (MVL', 'McGrath MAC® video laryngoscope']","['intubating profiles', 'modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score', 'time to intubation (TTI) and other intubating profiles']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451276', 'cui_str': 'Mallampati score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",222.0,0.0921774,"In both groups, the TTI was longer with a modified Mallampati score (mMS) of ≥3 and percentage of glottic opening (POGO) score of <50.","[{'ForeName': 'Hyunyoung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Centre, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520962951']
3161,33053597,Blood Pressure Response to Muscle Metaboreflex Activation is Impaired in Men Living with HIV.,"We investigated the muscle metaboreflex contribution to blood pressure response during dynamic handgrip exercise in men living with HIV (MLHIV) vs. without HIV (Controls). Pressor and heart rate responses were evaluated during metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER) in 17 MLHIV and 21 Controls. Protocols were performed randomly on the same day, being both sessions composed of 12 min, as follows: a) 3 min at rest, b) 3 min of dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3 min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3 min of recovery post-exercise without vascular occlusion. To assess metaboreflex response, differences between PEMI and CER in recovery post-exercise were calculated for blood pressure and heart rate. Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups. No difference was found between groups for blood pressure and heart rate (P>0.05). However, metaboreflex response for systolic blood pressure was lower in MLHIV vs. Controls (4.05±4.63 vs. 7.61±3.99 mmHg; P=0.01). In conclusion, pressor response during metaboreceptor stimulation was attenuated in men living with HIV, which may suggest loss of muscle metaboreflex sensibility.",2020,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"['men living with HIV', '17 MLHIV and 21 Controls', 'men living with HIV (MLHIV) vs. without HIV (Controls', 'Men Living with HIV']","['dynamic handgrip exercise at 30% of maximal voluntary contraction, c) 3\u2009min of recovery post-exercise with vascular occlusion (occlusion only in PEMI), and d) 3\u2009min of recovery post-exercise without vascular occlusion', 'metaboreflex activation through post-exercise muscle ischemia (PEMI) method and control exercise session (CER', 'dynamic handgrip exercise']","['blood pressure and heart rate', 'metaboreflex response', 'pressor response', 'Pressor and heart rate responses', 'metaboreflex response for systolic blood pressure', 'Blood Pressure Response', 'Systolic and mean blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237504', 'cui_str': 'CER'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.101859,Systolic and mean blood pressure (P<0.01) were superior in the last 2 min of recovery with vascular occlusion at PEMI in relation to CER for both groups.,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gama', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Department of Medical Science and Public Health, University of Cagliari, Italy.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}]",International journal of sports medicine,['10.1055/a-1263-1124']
3162,33053823,"Vitamin D Supplementation Does Not Impact Resting Metabolic Rate, Body Composition and Strength in Vitamin D Sufficient Physically Active Adults.","Supplementation with the most efficient form of Vitamin D (VitD3) results in improvements in energy metabolism, muscle mass and strength in VitD deficient individuals. Whether similar outcomes occur in VitD sufficient individuals' remains to be elucidated. The aim of this study is to determine the effect of VitD3 supplementation on resting metabolic rate (RMR), body composition and strength in VitD sufficient physically active young adults. Participants completed pre-supplementation testing before being matched for sunlight exposure and randomly allocated in a counterbalanced manner to the VitD3 or placebo group. Following 12 weeks of 50 IU/kg body-mass VitD3 supplementation, participants repeated the pre-supplementation testing. Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ). The VitD group increased serum total 25(OH)D by 30 nmol/L while the placebo group decreased total serum concentration by 21 nmol/L, reaching 123 (51) and 53 (42.2) nmol/L, respectively. There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period. Physically active young adults that are VitD sufficient have demonstrated that no additional physiological effects of achieving supraphysiological serum total 25(OH)D concentrations after VitD3 supplementation.",2020,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","['Physically active young adults', 'VitD sufficient physically active young adults', 'Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ', 'VitD deficient individuals']","['Vitamin D Supplementation', 'placebo', 'VitD3 or placebo', 'VitD3 supplementation', 'Vitamin D (VitD3']","['muscle strength or power, resting metabolic rate and body composition', 'resting metabolic rate (RMR), body composition and strength', 'total serum concentration', 'serum total 25(OH)D', 'energy metabolism, muscle mass and strength']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0523979', 'cui_str': 'Vitamin D3 measurement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",31.0,0.13748,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","[{'ForeName': 'Karina Romeu', 'Initials': 'KR', 'LastName': 'Montenegro', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cruzat', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Melder', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Newsholme', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Kagan J', 'Initials': 'KJ', 'LastName': 'Ducker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}]",Nutrients,['10.3390/nu12103111']
3163,33053843,Effect of Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation on Cognition in Children and Adolescents: A Systematic Literature Review with a Focus on n-3 LCPUFA Blood Values and Dose of DHA and EPA.,"Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in the cardiovascular field is effective if a certain Omega-3 index (O3I) is achieved or the daily n-3 LCPUFA dose is high enough. Whether this applies to studies on cognition in children and adolescents is unclear. The aims of the current review were to investigate whether: (1) a certain O3I level and (2) a minimum daily n-3 LCPUFA dose are required to improve cognition in 4-25 year olds. Web of Science and PubMed were searched. Inclusion criteria: placebo controlled randomized controlled trial; participants 4-25 years; supplementation with docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA); assessing cognition; in English and ≥10 participants per treatment arm. Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder. A positive effect on cognitive measures was more likely in studies with an increase in O3I to >6%. Half of the studies in typically developing children with daily supplementation dose ≥450 mg DHA + EPA showed improved cognition. For children with a disorder no cut-off value was found. In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.",2020,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","['Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder', 'English and ≥10 participants per treatment arm', 'Children and Adolescents', 'children and adolescents']","['DHA + EPA', 'Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation', 'Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation', 'placebo', 'docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA']","['cognitive measures', 'cognition']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.151666,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","[{'ForeName': 'Inge S M', 'Initials': 'ISM', 'LastName': 'van der Wurff', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Renate H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}]",Nutrients,['10.3390/nu12103115']
3164,33032917,The use of an activity tracker to objectively measure inpatient activity after bariatric surgery.,"BACKGROUND


Early postoperative ambulation reduces length of stay and prevents postoperative complications after bariatric surgery. Rarely is postoperative inpatient activity objectively measured despite readily available commercial activity trackers.
OBJECTIVES


Evaluate the impact of using activity trackers to record number of inpatient steps taken after bariatric surgery and assess how patient characteristics may affect the number of steps recorded.
SETTING


University Hospital, United States.
METHODS


Using an activity tracker, the number of steps taken during the postoperative hospital stay was recorded for 235 patients undergoing either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Patients were randomly assigned to either being informed about the devices' ability to record the number of steps taken or blinded to the purpose of the devices. Descriptive statistics were used to summarize study sample, a t test was used to compare number of steps recorded between groups, and a multivariate regression model was used to examine the effect of age, sex, preoperative body mass index (BMI), types of surgery, and length of stay on number of steps recorded.
RESULTS


One hundred twenty-five patients (52.8%) were randomized to the blinded group while 111 (47.2%) were informed that the device would record the number of steps taken. There were no differences in the number of steps recorded between the 2 groups. Patients with prolonged length of stay recorded lower numbers of steps taken on postoperative day 0. Increasing age was seen to reduce the number of steps recorded on postoperative day number 1. There were no significant differences in number of steps recorded based on sex, preoperative BMI, or surgery type.
CONCLUSION


The present study found that knowledge of an activity tracker being used did not affect the patient's activity level as measured by steps recorded. Increasing age correlated to reduced number of steps recorded on postoperative day 1 after bariatric surgery.",2020,There were no differences in the number of steps recorded between the 2 groups.,"['235 patients undergoing either', 'University Hospital, United States', 'One hundred twenty-five patients (52.8']","['activity tracker', 'laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy']","['number of steps', ""patient's activity level"", 'preoperative body mass index (BMI), types of surgery, and length of stay on number of steps recorded', 'number of steps recorded based on sex, preoperative BMI, or surgery type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",235.0,0.0398186,There were no differences in the number of steps recorded between the 2 groups.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Tabone', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States. Electronic address: letabone@hsc.wvu.edu.'}, {'ForeName': 'Jiyoung K', 'Initials': 'JK', 'LastName': 'Tabone', 'Affiliation': 'School of Social Work, West Virginia University, Morgantown, West Virginia, United States.'}, {'ForeName': 'Nova', 'Initials': 'N', 'LastName': 'Szoka', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abunnaja', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.08.033']
3165,33031329,Effects of dapagliflozin on cardiovascular outcomes in type 2 diabetes: Study protocol of a randomized controlled trial.,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. This current research is a double blinded, randomized, and prospective trial to determine the effect of dapagliflozin on cardiovascular outcomes in type 2 diabetes.
METHODS


This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001). All the patients received the informed consent. Diabetic patients were randomized equally to receive 28-week treatment with dapagliflozin or matching placebo. The major outcome of our current study was the change in the level of hemoglobin A1c (HbA1c) from the baseline to week 28. Secondary outcome measures contained the levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose in patients treated with insulin at baseline, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.
RESULTS


We assumed that the dapagliflozin administration in patients with type 2 diabetes would reduce HbA1c, body weight, systolic blood pressure, and achieve the goal of glycemic control, without adversely impacting cardiovascular risk.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5987).",2020,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","['type 2 diabetes', 'patients with type 2 diabetes', 'Diabetic patients', 'Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001']","['dapagliflozin or matching placebo', 'dapagliflozin']","['cardiovascular outcomes', 'laboratory variables, and self-reported adverse events', 'levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose', 'HbA1c, body weight, systolic blood pressure', 'level of hemoglobin A1c (HbA1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.258031,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'Department of endocrinology, Lianyungang Hospital affiliated to Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': ''}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022660']
3166,33031335,Impacts of cognitive behavior therapy on occupational stress among science and social science education facilitators in open and distance learning centers and its implications for community development: A randomized trial group.,"BACKGROUND


Extensive review of literature showed that no available study in Nigeria has explored the impact of cognitive behavior therapy (CBT) on the management of occupational stress among open and distance learning (ODL) centers science and social science education facilitators. Thus, this study determined the impacts of CBT on the management of occupational stress among science and social science education facilitators in ODL centers in South-South Nigeria.
METHODS


A randomized controlled trial experimental design was adopted for the study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria. Perceived stress scale (PSS) and Occupational stress index (OSI) were used for data collection. Using Cronbach alpha method, internal consistency reliability indices of 0.81 and 0.85 for PSS and OSI respectively were obtained in the Nigerian context. A 12-week cognitive behavior therapy intervention was conducted after which the participants in both the intervention group and the non-intervention group were administered posttest, while a follow-up assessment was administered after 2 months. Data collected were analyzed using mixed-design repeated-measures analysis of variance for the within-groups and between-groups effects.
RESULTS


It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
CONCLUSION


Cognitive behavior therapy is effective in the management of occupational stress among science and social science education facilitators in distance learning centers.",2020,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","['study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria', 'ODL centers in South-South Nigeria']","['CBT', 'cognitive behavior therapy intervention', 'cognitive behavior therapy (CBT', 'Cognitive behavior therapy', 'CBT intervention', 'cognitive behavior therapy']","['Perceived stress scale (PSS) and Occupational stress index (OSI', 'occupational stress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0037434', 'cui_str': 'Social Sciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0600563', 'cui_str': 'Distance Learning'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",68.0,0.0278059,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi Justina', 'Initials': 'NJ', 'LastName': 'Igwe', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi M', 'Initials': 'NM', 'LastName': 'Eya', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Jovita C', 'Initials': 'JC', 'LastName': 'Ejimonye', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Basil C', 'Initials': 'BC', 'LastName': 'Oguguo', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chinyere L', 'Initials': 'CL', 'LastName': 'Chukwu', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Obiozor', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Maryrose N', 'Initials': 'MN', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ruphina U', 'Initials': 'RU', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Uzoamaka L', 'Initials': 'UL', 'LastName': 'Koledoye', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Queendaline O', 'Initials': 'QO', 'LastName': 'Ibenegbu', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Francis E', 'Initials': 'FE', 'LastName': 'Ikeh', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Monday', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Florence O', 'Initials': 'FO', 'LastName': 'Attah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chiamaka K', 'Initials': 'CK', 'LastName': 'Ugwuanyi', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}]",Medicine,['10.1097/MD.0000000000022677']
3167,33031340,The efficacy of bilateral intervertebral foramen block for pain management in percutaneous endoscopic lumbar discectomy: A protocol for randomized controlled trial.,"BACKGROUND


Compared with open lumbar microdiscectomy, percutaneous endoscopic lumbar discectomy (PELD) has the advantages of remarkable preservation of paravertebral structures, less bleeding, shorter operation time and fewer complications, it is a common method for the treatment of lumbar disc herniation (LDH). Local anesthesia is recommended during PELD. However, intraoperative pain is sometimes difficult to control satisfactorily. The efficacy of bilateral intervertebral foramen block (IFB) for pain management in PELD remains unclear. Therefore, this regimen is utilized in a randomized controlled trial for the assessment the safety and effectiveness of bilateral IFB for PELD pain control.
METHOD


This is a single center and randomized controlled trial which will be implemented from September 2020 to September 2021. This research protocol is in accordance with the items of the Standard Protocol for Randomized Trials, which was authorized through the Ethics Committee of Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou University (HZCH0465-0864). 100 participants who undergo PELD will be analyzed. Inclusion criteria containsThe exclusion criteria contains:Patients will be randomly divided into bilateral IFB group (with 50 patients) and local infiltration analgesia group (with 50 patients). Primary outcomes are pain score at different time points. The secondary outcomes are the operative time, radiation exposure time, length of hospital stay and postoperative complications. All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
RESULTS


The clinical outcome variables between groups are illustrated in the Table 1.
CONCLUSION


This investigation can offer a reliable basis for the effectiveness and safety of IFB in treating the PELD pain.
TRIAL REGISTRATION


This study protocol is registered in Research Registry (researchregistry5985).",2020,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","['September 2020 to September 2021', '100 participants who undergo PELD will be analyzed', 'percutaneous endoscopic lumbar discectomy']","['IFB', 'bilateral intervertebral foramen block', 'local infiltration analgesia', 'bilateral IFB', 'percutaneous endoscopic lumbar discectomy (PELD', 'bilateral intervertebral foramen block (IFB']","['pain score', 'operative time, radiation exposure time, length of hospital stay and postoperative complications']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",100.0,0.179244,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","[{'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Sang', 'Affiliation': 'Department of operating room, Huzhou Central Hospital & Affiliated Central Hospital of Huzhou University.'}, {'ForeName': 'Hanmin', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics and Trauma, Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou Unversity, Zhejiang Province, China.'}]",Medicine,['10.1097/MD.0000000000022693']
3168,31394914,Polysomnographic Endotyping to Select Patients with Obstructive Sleep Apnea for Oral Appliances.,"Rationale:  Oral appliance therapy is efficacious in many patients with obstructive sleep apnea (OSA), but prediction of treatment outcome is challenging. Small, detailed physiological studies have identified key OSA endotypic traits (pharyngeal collapsibility and loop gain) as determinants of greater oral appliance efficacy. Objectives:  We used a clinically applicable method to estimate OSA traits from routine polysomnography and identify an endotype-based subgroup of patients expected to show superior efficacy. Methods:  In 93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h), we examined whether polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal) were associated with oral appliance efficacy (percentage reduction in AHI from baseline) and could predict responses to treatment. Multivariable regression (with interactions) defined endotype-based subgroups of ""predicted"" responders and nonresponders (based on 50% reduction in AHI). Treatment efficacy was compared between the predicted subgroups (with cross-validation). Results:  Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003). Predicted responders ( n  = 54), compared with predicted nonresponders ( n  = 39), exhibited a greater reduction in AHI from baseline (mean [95% confidence interval], 73% [66-79] vs. 51% [38-61];  P  < 0.0001) and a lower treatment AHI (8 [6-11] vs. 16 [12-20] events/h;  P  = 0.002). Differences persisted after adjusting for clinical covariates (including baseline AHI, body mass index, and neck circumference). Conclusions:  Quantifying OSA traits using clinical polysomnography can identify an endotype-based subgroup of patients that is highly responsive to oral appliance therapy. Prospective validation is warranted.",2019,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003).","['93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h', 'many patients with obstructive sleep apnea (OSA', 'Patients with Obstructive Sleep Apnea for Oral Appliances']",['Oral appliance therapy'],"['Greater oral appliance efficacy', 'Treatment efficacy', 'favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation', 'polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",,0.03276,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003).","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Bamagoos', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sutherland', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Madronio', 'Affiliation': 'Centre for Sleep Health and Research, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Sleep and Breathing Lab, Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, and.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201903-190OC']
3169,33037810,Effect of zinc on oropharyngeal mucositis in children with acute leukemia undergoing chemotherapy.,"BACKGROUND


Oropharyngeal mucositis (OM) is one of the main side-effects of oncological therapy. There is no treatment to prevent its occurrence, but some zinc-based therapies have been proven to help in decreasing its intensity. The objective of this study was to determine the effect of zinc in OM in children with acute leukemia in the early stages of oncological treatment.
MATERIAL AND METHODS


This quasi-experimental study evaluated OM in 2 groups (control group: conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management). OM severity was recorded at a two-month follow-up.
RESULTS


Forty-nine patients (26 in the control group and 23 in the experimental group) were included. The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia. The incidences of OM in the control group and the experimental group were 46.2% and 26.1%, respectively, but the difference was not significant. Based on a negative binomial regression model, females had, on average, 1.5 more days with OM (p = 0.002), and patients assigned to the experimental group had, on average, 2 less days with OM than the control group (p = 0.001). The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
CONCLUSIONS


Zinc facilitated a reduction in the severity and duration of OM; further studies focusing on children are needed to confirm the effects of this trace element.",2020,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","['children with acute leukemia in the early stages of oncological treatment', 'children with acute leukemia undergoing chemotherapy', 'The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia', '2 groups (control group', 'Forty-nine patients (26 in the control group and 23 in the experimental group) were included']","['conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management', 'zinc in OM', 'zinc']","['incidences of OM', 'severity and duration of OM', 'mean score on the WHO scale', 'pain score', 'OM severity', 'oropharyngeal mucositis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023485', 'cui_str': 'Leukemia, Pre-B-Cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0392876,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutiérrez-Vargas', 'Affiliation': 'Oncology Department National Institute of Pediatrics, Health Secretary Insurgentes Sur 3700-C, Insurgentes Cuicuilco Coyoacan, Mexico City, 04530 mzapatatarres@gmail.com.'}, {'ForeName': 'M-Á', 'Initials': 'MÁ', 'LastName': 'Villasis-Keever', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portilla-Robertson', 'Affiliation': ''}, {'ForeName': 'I-D', 'Initials': 'ID', 'LastName': 'Ascencio-Montiel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zapata-Tarrés', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23798']
3170,33037918,Palbociclib (PD-0332991) pharmacokinetics in subjects with impaired renal function.,"PURPOSE


This publication describes an evaluation of the impact of different degrees of renal impairment on the pharmacokinetics and safety of palbociclib after a single 125-mg oral dose.
METHODS


Thirty-one subjects were assigned to different renal function groups. Serial blood sampling for pharmacokinetics was performed up to 120 h and 168 h post-palbociclib dose for subjects with normal and impaired renal function, respectively. A separate blood sample was collected at pre-dose and 8 h after dosing to measure plasma protein binding. Plasma palbociclib was measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Plasma protein binding samples were processed by equilibrium dialysis and measured by a validated LC-MS/MS method.
RESULTS


Plasma palbociclib exposure was higher in subjects with renal impairment than in subjects with normal renal function; however, there were no marked differences in exposure across subjects with mild, moderate, and severe renal impairment. Total plasma exposure AUC inf  increased by 39%, 42%, and 31% with mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. Peak exposure C max  increased by 17%, 12%, and 15% for mild, moderate, and severe impairment, respectively. There was no obvious trend in the mean f u  with worsening renal function. The PBPK model adequately described palbociclib exposure observed in subjects with moderate or severe renal impairment from this study.
CONCLUSION


Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose. No dose adjustment is required in patients with renal impairment.",2020,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"['patients with renal impairment', 'subjects with impaired renal function', 'Thirty-one subjects', 'subjects with moderate or severe renal impairment from this study']",['Palbociclib'],"['renal function', 'Plasma palbociclib', 'severe renal impairment', 'Total plasma exposure AUC inf', 'mean f u  with worsening renal function', 'Peak exposure C max', 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",31.0,0.019983,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"[{'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plotka', 'Affiliation': 'Biostatistics, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': ""O'Gorman"", 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA. Diane.Wang@pfizer.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04163-4']
3171,33035416,[The role of sleep in the relational memory processes].,"Background and purpose


A growing body of evidence suggests that sleep plays an essential role in the consolidation of different memory systems, but less is known about the beneficial effect of sleep on relational memory processes and the recognition of emotional facial expressions, however, it is a fundamental cognitive skill in human everyday life. Thus, the study aims to investigate the effect of timing of learning and the role of sleep in relational memory processes.
Methods


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Results


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Conclusion


Our results suggest that the timing of learning and sleep plays an important role in the stabilizing process of memory representation to resist against forgetting.",2020,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","['84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female']",['evening group and morning group indicating the time of learning'],['relational memory and facial expression recognition'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",84.0,0.0199132,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","[{'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Csábi', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Zámbó', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Prokecz', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}]",Ideggyogyaszati szemle,['10.18071/isz.73.0327']
3172,33036366,Biopsy-Controlled Non-Invasive Quantification of Collagen Type VI in Kidney Transplant Recipients: A Post-Hoc Analysis of the MECANO Trial.,"The PRO-C6 assay, a reflection of collagen type VI synthesis, has been proposed as a non-invasive early biomarker of kidney fibrosis. We aimed to investigate cross-sectional and longitudinal associations between plasma and urine PRO-C6 and proven histological changes after kidney transplantation. The current study is a post-hoc analysis of 94 participants of the MECANO trial, a 24-month prospective, multicenter, open-label, randomized, controlled trial aimed at comparing everolimus-based vs. cyclosporine-based immunosuppression. PRO-C6 was measured in plasma and urine samples collected 6 and 24 months post-transplantation. Fibrosis was evaluated in biopsies collected at the same time points by Banff interstitial fibrosis/tubular atrophy (IF/TA) scoring and collagen staining (Picro Sirius Red; PSR); inflammation was evaluated by the tubulo-interstitial inflammation score (ti-score). Linear regression analyses were performed. Six-month plasma PRO-C6 was cross-sectionally associated with IF/TA score (Std. β = 0.34), and prospectively with 24-month IF/TA score and ti-score (Std. β = 0.24 and 0.23, respectively) ( p  < 0.05 for all). No significant associations were found between urine PRO-C6 and any of the biopsy findings. Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy. These results are a first step towards non-invasive fibrosis detection after kidney transplantation by means of collagen VI synthesis measurement, and further research is required.",2020,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"['kidney transplantation', 'Kidney Transplant Recipients', '94 participants of the MECANO trial']",['everolimus-based vs. cyclosporine-based immunosuppression'],"['PRO-C6', 'urine PRO-C6', 'collagen staining (Picro Sirius Red; PSR); inflammation', 'Fibrotic changes and urine PRO-C6', '24-month IF/TA score and ti-score']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1265831', 'cui_str': 'Interstitial inflammation'}]",94.0,0.0197494,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Yepes-Calderón', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Camilo G', 'Initials': 'CG', 'LastName': 'Sotomayor', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Daniel Guldager Kring', 'Initials': 'DGK', 'LastName': 'Rasmussen', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Ryanne S', 'Initials': 'RS', 'LastName': 'Hijmans', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Te Velde-Keyzer', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'van Londen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'van Dijk', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Diepstra', 'Affiliation': 'Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Morten Asser', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Frederike J', 'Initials': 'FJ', 'LastName': 'Bemelman', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, University of Leiden, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kers', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Florquin', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genovese', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jan-Stephan', 'Initials': 'JS', 'LastName': 'Sanders', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Den Born', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103216']
3173,33036371,"Combining Effect and Process Evaluation on European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family-Involved Cluster Randomized Controlled Trial: The ToyBox Study.","This study aimed at (1) studying the effect of the standardized ToyBox intervention on European preschoolers' snacking behavior, and (2) studying whether a higher process evaluation score from teachers and parents/caregivers was associated with a more positive result for preschoolers' snack intake. A sample of 4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire. To investigate the effect of the intervention, multilevel repeated measures analyses were executed for the total sample and the six country-specific samples. Furthermore, questionnaires to measure process evaluation were used to compute a total process evaluation score for teachers and parents/caregivers. No significant intervention effects on preschoolers' snack intake were found (all  p  > 0.003). In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores. The lack of effects could be due to limited intervention duration and dose. To induce larger effects on preschoolers' snack intake, a less standardized intervention which is more tailored to the local needs might be needed.",2020,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","['4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire', ""European preschoolers' snacking behavior, and (2"", ""European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family""]",['standardized ToyBox intervention'],"[""preschoolers' snack intake"", 'snack intake']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517459', 'cui_str': '0.44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",4970.0,0.0814874,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Verbestel', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Research Foundation Flanders, 1000 Brussels, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, University of Thessaly, Sport Science and Dietetics, 421 00 Trikala, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Department of Physiatry and Nursing, GENUD (Growth, Exercise, Drinking Behaviour and Development), University of Zaragoza, 50001 Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Pediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Dr. von Hauner Children's Hospital, University of Munich Medical Centre, 80337 Munich, Germany.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Socha', 'Affiliation': ""Children's Memorial Institute, 04-730 Warsaw, Poland.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, 17778 Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph17197312']
3174,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION


E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD


The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS


The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
3175,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND


Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS


This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS


Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION


Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
3176,33044102,Method for evaluating the human bioequivalence of acarbose based on pharmacodynamic parameters.,"OBJECTIVE


To explore a method for evaluating the bioequivalence of acarbose based on pharmacodynamic parameters using a single-dose, randomized-sequence, three-way crossover study of acarbose test (T) and reference (R) formulations.
METHODS


Baseline-adjusted, pre-dose value deduction, and direct comparison methods were used to evaluate the geometric T/R ratios and 90% confidence intervals (CIs) of the ln-transformed pharmacodynamic parameters to identify the most suitable evaluation system. Twelve participants were randomly divided into three groups to receive treatment in the following sequences: TRR, RTR, and RRT, each including a 7-day washout period between treatment periods. The serum glucose concentration (baseline) was determined. Pharmacodynamic parameters, including the maximum reduction in serum glucose concentrations (ΔC SG,max ) and difference of the AUC of glucose between before and after acarbose exposure (ΔAUEC), were tested.
RESULTS


Using the direct comparison method, the geometric mean ratios of C SG,max , AUEC (0-2h) , and AUEC (0-4h)  were 94.13%, 97.82% and 99.76%, respectively. The 90% CIs of the geometric T/R ratios for C SG,max , AUEC (0-2h),  and AUEC (0-4h)  all fell between 80% and 125%. Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
CONCLUSIONS


Pre-dose value deduction and direct comparison methods can be initially considered suitable for assessing acarbose bioequivalence.",2020,"Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
",['Twelve participants'],"['acarbose test (T) and reference (R) formulations', 'acarbose']","['geometric mean ratios of C SG,max , AUEC (0-2h) , and AUEC (0-4h', 'geometric T/R ratios for C SG,max , AUEC (0-2h),  and AUEC', 'serum glucose concentrations (ΔC SG,max ) and difference of the AUC of glucose', 'Conversely, ΔC SG,max  and ΔAUEC', 'serum glucose concentration (baseline']",[],"[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",12.0,0.0163034,"Conversely, ΔC SG,max  and ΔAUEC (0-4h)  were less reliable measures of acarbose bioequivalence.
","[{'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Yu-Ying', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Xu', 'Affiliation': 'National Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.'}]",The Journal of international medical research,['10.1177/0300060520960317']
3177,33039717,Nasal function and cardio-respiratory capacity of adolescent with external nasal dilator.,"BACKGROUND


the external nasal dilator (END) has been employed for the purpose of aiding sporting performance. The objective of this study was to evaluate nasal function and cardio-respiratory capacity in healthy adolescent athletes using the END.
METHODS


double-blind, crossover clinical trial in which adolescents were evaluated while using the experimental and placebo END during physical exercise. Values for peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max) were obtained in randomized order. Additionally, the rating of perceived exertion (RPE) after the cardio-respiratory test was assessed.
RESULTS


for the 71 adolescents evaluated, the use of the experimental END, compared to the placebo, produced a significant improvement in values of PNIF (177.4 ± 20.9 L/min and 172.8 ± 20.2 L/min) (p = 0.020), NR (0.24 ± 0.16 and 0.27 ± 0.16) (p = 0.007), VO 2 max. (39.5 ± 5.2 mL/kg. min-1 and 37.5 ± 5.2 mL/kg. min-1) (p < 0.001) and RPE (6.0 ± 2.2 and 5.5 ± 2.4) (p < 0.001), respectively.
CONCLUSION


the END reduced NR, increased PNIF and improved VO 2 max. In addition, it improved RPE after the maximal cardio-respiratory test. The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.",2020,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","['adolescent with external nasal dilator', 'healthy adolescent athletes', 'adolescent athletes']","['placebo', 'external nasal dilator (END']","['rating of perceived exertion (RPE', 'Nasal function and cardio-respiratory capacity', 'values of PNIF', 'nasal function and cardio-respiratory capacity', 'PNIF and improved VO 2 max', 'nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion', 'peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.146487,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","[{'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Santos Ferreira', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Ricardo Reis', 'Initials': 'RR', 'LastName': 'Dinardi', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil; Pontifical Catholic University of Minas Gerais, Department of Physical Education. Belo Horizonte, MG, Brazil. Electronic address: dinardi06@hotmail.com.'}, {'ForeName': 'Cássio', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110430']
3178,33039810,"Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study.","BACKGROUND


Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity.
PATIENTS AND METHODS


Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks.
RESULTS


Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
CONCLUSIONS


Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03212625).",2020,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","['Patients with HCC', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma (HCC', '288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group']","['Hand-foot skin reaction (HFSR', 'placebo cream or urea cream', 'sorafenib treatment', 'urea cream']","['incidence of severe HFSR of grade II or higher', 'HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events', 'HF-QoL questionnaire score', 'cumulative incidence of any-grade HFSR', 'tendency of HFSR development', 'severe HFSR of grade II', 'sorafenib-associated hand-foot skin reaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",288.0,0.149479,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","[{'ForeName': 'Young-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: lys810@korea.ac.kr.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: kjhhepar@naver.com.'}, {'ForeName': 'Sung B', 'Initials': 'SB', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, South Korea. Electronic address: portalvein@naver.com.'}, {'ForeName': 'Do Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Yonsei Liver Center, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Moon Y', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christan Hospital, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yeon S', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki T', 'Initials': 'KT', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young M', 'Initials': 'YM', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, South Korea.'}, {'ForeName': 'Hyun W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byoung K', 'Initials': 'BK', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, South Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Jang', 'Affiliation': 'Department of Intetnal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi, South Korea.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Y', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological & Medical Sciences, South Korea.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.012']
3179,33039853,Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.,"OBJECTIVES


Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception.
MATERIALS AND METHODS


Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS).
RESULTS


Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS).
CONCLUSION


The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.",2020,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[""Parkinson's patients with dysphagia"", 'Twenty-five patients with PD', 'Twenty patients concluded the study (10 each group', ""patients with Parkinson's disease and swallowing deficiency""]","['expiratory flow acceleration (EFA®) technique to standard therapy (ST', 'EFA® technology', 'expiratory flow acceleration', 'ST vs. ST\u202f+\u202fEFA']","['cough effectiveness', 'changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS', 'peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS', 'respiratory infections, symptoms, hospital admissions and medical visits', 'incidence of respiratory exacerbations together with quality of life score (PDQ-39', 'quality of life, respiratory function parameters, cough, and airways encumbrance perception']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",25.0,0.0541415,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': ""Parkinson's Disease Unit, Gaetano and Piera Borghi Foundation, Brebbia, Italy.""}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Spinazza', 'Affiliation': 'Neurology Rehabilitation Department, Hospital of Cuasso al Monte, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'Italian Association of Respiratory Physiotherapists (ARIR), Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy. Electronic address: antonellonicolini@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106249']
3180,33034942,"A randomized, placebo and active controlled, split scalp study to evaluate the efficacy of platelet-rich plasma in patchy alopecia areata of the scalp.","Platelet-rich plasma (PRP) is a new modality of treatment in the field of dermatology. There are paucity of studies evaluating the effects of PRP in nonscarring alopecia especially alopecia areata (AA). To compare the efficacy and safety of PRP in patchy AA of the scalp in a placebo and active controlled trial. This was a randomized, placebo and active controlled, split scalp study. Fifty patients of patchy AA of the scalp were recruited and allocated to two treatment groups. Left side of the scalp received placebo (intralesional normal saline), right side of the scalp received intralesional PRP in one group and intralesional triamcinolone acetonide in second group. Three treatment sessions were given at 4-week interval and final follow-up was done at 8 weeks later. SALT scoring, dermoscopy were the parameters used to assess the efficacy. The SALT score showed statistically significant improvement from baseline in both the treatment groups (P value <.001). The maximum absolute regrowth was shown by the steroid group followed by PRP followed by placebo group (P value .016). Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (P value .448). PRP is a promising therapy in AA as an adjuvant in those with minimal response and those not tolerating steroids or have developed adverse effects to it.",2020,"Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (p value 0.448).
","['patchy alopecia areata of the scalp', 'Fifty patients of patchy AA of the scalp']","['PRP', 'placebo', 'placebo (intralesional normal saline), right side of the scalp received intralesional PRP', 'platelet rich plasma', 'triamcinolone acetonide']","['efficacy', 'dermoscopic findings', 'maximum absolute regrowth']","[{'cui': 'C1862862', 'cui_str': 'Patchy alopecia'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",50.0,0.220652,"Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (p value 0.448).
","[{'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Hegde', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Relhan', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Bijaylaxmi', 'Initials': 'B', 'LastName': 'Sahoo', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Garg', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Santosh Medical College, Ghaziabad, India.'}]",Dermatologic therapy,['10.1111/dth.14388']
3181,33038066,A high salt meal does not impair cerebrovascular reactivity in healthy young adults.,"A high sodium (Na +  ) meal impairs peripheral vascular function. In rodents, chronic high dietary Na +  impairs cerebral vascular function, and in humans, habitual high dietary Na +  is associated with increased stroke risk. However, the effects of acute high dietary Na +  on the cerebral vasculature in humans are unknown. The purpose of this study was to determine if acute high dietary Na +  impairs cerebrovascular reactivity in healthy adults. Thirty-seven participants (20F/17M; 25 ± 5 years; blood pressure [BP]: 107 ± 9/61 ± 6 mm Hg) participated in this randomized, cross-over study. Participants were given a low Na +  meal (LSM; 138 mg Na +  ) and a high Na +  meal (HSM; 1,495 mg Na +  ) separated by ≥ one week. Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ) were measured pre- (baseline) and 60 min post-prandial. Cerebrovascular reactivity was assessed by determining the percent change in middle cerebral artery velocity to hypercapnia (via 8% CO 2  , 21% oxygen, balance nitrogen) and hypocapnia (via mild hyperventilation). Peripheral vascular function was measured using brachial artery flow-mediated dilation (FMD). Changes in serum Na +  were greater following the HSM (HSM: Δ1.6 ± 1.2 mmol/L vs. LSM: Δ0.7 ± 1.2 mmol/L, p < .01). Cerebrovascular reactivity to hypercapnia (meal effect: p = .41) and to hypocapnia (meal effect: p = .65) were not affected by the HSM. Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74). These data suggest that a single high Na +  meal does not acutely impair cerebrovascular reactivity, and suggests that despite prior findings, a single high Na +  meal does not impair peripheral vascular function in healthy adults.",2020,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","['healthy young adults', 'Thirty-seven participants (20F/17M; 25\xa0±\xa05\xa0years; blood pressure [BP]: 107\xa0±\xa09/61\xa0±\xa06\xa0mm\xa0Hg', 'healthy adults']","['high Na +  meal (HSM; 1,495\xa0mg Na +  ) separated by\xa0≥\xa0one week', 'sodium (Na +  ) meal', 'dietary Na ', 'low Na +  meal (LSM; 138']","['Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ', 'Cerebrovascular reactivity to hypercapnia', 'Peripheral vascular function', 'brachial artery flow-mediated dilation (FMD', 'middle cerebral artery velocity to hypercapnia', 'cerebrovascular reactivity', 'Cerebrovascular reactivity', 'Changes in serum Na ', 'peripheral vascular function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.0392972,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14585']
3182,33036174,PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study (CANVAS).,"The ability of current tests to predict chronic kidney disease (CKD) complicating diabetes is limited. This study investigated the prognostic utility of a novel blood test, PromarkerD, for predicting future renal function decline in individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS). PromarkerD scores were measured at baseline in 3568 CANVAS participants ( n  = 1195 placebo arm,  n  = 2373 canagliflozin arm) and used to predict incident CKD (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m 2  during follow-up in those above this threshold at baseline) and eGFR decline ≥30% during the 4 years from randomization. Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum high-density lipoprotein (HDL)-cholesterol, eGFR) using a previously defined algorithm to provide PromarkerD scores categorized as low-, moderate- or high-risk. The participants (mean age 63 years, 33% females) had a median PromarkerD score of 2.9%, with 70.5% categorized as low-risk, 13.6% as moderate-risk and 15.9% as high-risk for developing incident CKD. After adjusting for treatment, baseline PromarkerD moderate-risk and high-risk scores were increasingly prognostic for incident CKD (odds ratio 5.29 and 13.52 versus low-risk, respectively; both  p  < 0.001). Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.",2020,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,['individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS'],[],"['Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3', 'PromarkerD scores', 'median PromarkerD score', 'baseline PromarkerD moderate-risk and high-risk scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C1528456', 'cui_str': 'CD5L protein, human'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",3568.0,0.046152,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,"[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Peters', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Bringans', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hansen', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Lipscombe', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9103212']
3183,33036179,"One Year's Treatment with the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide Decreases Hepatic Fat Content in Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus in a Randomized, Placebo-Controlled Trial.","Prior gestational diabetes mellitus (pGDM) is associated with increased risk of nonalcoholic fatty liver disease (NAFLD). Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists has shown beneficial effects in NAFLD patients. We evaluated the effect of the GLP-1 analogue liraglutide on NAFLD features in women with pGDM. Eighty-two overweight/obese, nondiabetic women with pGDM were included. We performed abdominal ultrasound, transient elastography with controlled attenuation parameter (CAP), and blood sampling at baseline and after 1 year. Thirty-seven women were randomized to liraglutide (1.8 mg once-daily) and 45 to placebo. Based on the ultrasound scan, 18 women (22%) had ultrasound-verified NAFLD at baseline and of these, 10 (56%) received liraglutide treatment. After 1 year, eight participants no longer had steatosis, four in each treatment group. The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74). Compared to placebo, liraglutide reduced the CAP-assessed intrahepatic fat content (-28 (-44;-11) vs. 2 (-13;18) dB/m,  p <  0.01) and body weight (-4.7 (-6.4;-2.9) vs. -1.4 (-3;0.3) kg,  p <  0.01). One-year's liraglutide treatment had no effect on the presence of ultrasound-diagnosed NAFLD in overweight/obese nondiabetic women with pGDM, but reduced body weight and steatosis assessed by transient elastography with CAP.",2020,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"['Thirty-seven women', 'Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus', 'Prior gestational diabetes mellitus (pGDM', 'women with pGDM', 'Eighty-two overweight/obese, nondiabetic women with pGDM were included', 'NAFLD patients']","['liraglutide treatment', 'liraglutide', 'glucagon-like peptide 1 (GLP-1) receptor agonists', 'placebo, liraglutide', 'Glucagon-Like Peptide 1 Receptor Agonist Liraglutide', 'placebo', 'GLP-1 analogue liraglutide', 'Placebo']","['presence of ultrasound-diagnosed NAFLD', 'NAFLD features', 'body weight', 'CAP-assessed intrahepatic fat content', 'NAFLD', 'body weight and steatosis']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",82.0,0.352378,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Vedtofte', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bahne', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Foghsgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jonatan I', 'Initials': 'JI', 'LastName': 'Bagger', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Andreasen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Strandberg', 'Affiliation': 'Department of Radiology, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 4A, 2900 Hellerup, Denmark.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gørtz', 'Affiliation': 'Department of Nuclear Medicine, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 2, 1st floor, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, University of Aarhus, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Svare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 21, 2730 Herlev, Denmark.'}, {'ForeName': 'Tine D', 'Initials': 'TD', 'LastName': 'Clausen', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Lise L', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm9103213']
3184,33036224,Vitamin K Intake in Chronic Stroke: Implications for Dietary Recommendations.,"Previous research has identified a possible association between vitamin K intake and cardiometabolic disease. This could mean that the assessment of vitamin K intake is a meaningful tool when monitoring individuals with preexisting cardiovascular disease. Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings. Participants were divided into two groups: below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation (MET,  n  = 11). Energy and macronutrient intake did not differ between groups (all  p  > 0.127). Vegetable intake was higher in the MET group ( p  = 0.0001). Vitamin K intake was higher in the MET group ( p  = 0.0001). Calcium ( p  = 0.003), vitamin A ( p  = 0.007), and vitamin E ( p  = 0.005) intakes were higher in the MET group. There were no differences in sodium, potassium, vitamin D, vitamin C, and iron intakes between groups (all  p  > 0.212). In this sample of chronic stroke survivors, 82% reported consuming below the Dietary Reference Intake (DRI) for vitamin K. Given that the majority of this study population did not reach the DRI for vitamin K, it is advisable to promote the adequate intake of food rich in vitamin K. Further work is needed to determine the significance of low vitamin K intake in this population.",2020,Vegetable intake was higher in the MET group ( p  = 0.0001).,"['Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings', 'individuals with preexisting cardiovascular disease', 'Chronic Stroke']","['vitamin K intake', 'below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation', 'Vitamin K Intake']","['Vegetable intake', 'Vitamin K intake', 'vitamin E', 'Energy and macronutrient intake', 'sodium, potassium, vitamin D, vitamin C, and iron intakes']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",,0.0550242,Vegetable intake was higher in the MET group ( p  = 0.0001).,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Wessinger', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Hafer-Macko', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'S Ryan', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}]",Nutrients,['10.3390/nu12103059']
3185,33039447,N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes: Vericiguat Heart Failure With Reduced Ejection Fraction Study.,"OBJECTIVES


The purpose of this study was to examine the treatment effect of vericiguat in relation to N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at randomization.
BACKGROUND


Vericiguat compared with placebo reduced the primary outcome of cardiovascular death (CVD) or heart failure hospitalization (HFH) in patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction) trial. Because an interaction existed between treatment and the primary outcome according to pre-specified quartiles of NT-proBNP at randomization, we examined this further.
METHODS


This study evaluated the NT-proBNP relationship with the primary outcome in 4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented.
RESULTS


Median NT-proBNP was 2,816 pg/ml (25th to 75th percentile: 1,556 to 5,314 pg/ml). The study treatment effect varied across the spectrum of NT-proBNP at randomization (with log 2  transformation, p for interaction = 0.002). A significant association between treatment effects existed in patients with levels <4,000 pg/ml and remained evident up to 8,000 pg/ml. A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88). For NT-proBNP values ≤4,000 pg/ml (n = 3,100), the HR was 0.78 (95% CI: 0.67 to 0.90) for HFH and 0.75 (95% CI: 0.60 to 0.94) for CVD. For NT-proBNP ≤8,000 pg/ml (n = 4,133), the HR was 0.85 (95% CI: 0.76 to 0.95) for the primary outcome, 0.84 (95% CI: 0.75 to 0.95) for HFH, and 0.84 (95% CI: 0.71 to 0.99) for CVD. For NT-proBNP >8,000 pg/ml (n = 672), the HR was 1.16 (95% CI: 0.94 to 1.41) for the primary outcome.
CONCLUSIONS


A reduction in the primary composite endpoint and its CVD and HFH components was observed in patients on vericiguat compared with subjects on placebo with NT-proBNP levels up to 8,000 pg/ml. This provided new insight into the benefit observed in high-risk patients with worsening HFrEF. (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction [HFrEF] [MK-1242-001] [VICTORIA]; NCT02861534).",2020,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","['4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable', 'high-risk patients with worsening HFrEF', 'patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart\xa0Failure With Reduced Ejection Fraction) trial', 'Participants With Heart']","['HFrEF', 'placebo', 'MK-1242-001] [VICTORIA']","['cardiovascular death (CVD) or heart failure hospitalization (HFH', 'Hazard ratios (HRs) and 95% confidence intervals (CIs', 'Vericiguat Heart', 'CVD and HFH components', 'Failure With Reduced Ejection Fraction', 'risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.381183,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","[{'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Wendimagegn G', 'Initials': 'WG', 'LastName': 'Alemayehu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Cardiology, National Heart Centre Singapore and Duke-National University of Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Department of Heart Disease, Wroclaw, Poland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Cardiothoracic Department, Fondazione Toscana Gabriele Monasterio, Pisa, Italy; and Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine-Cardiology, Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada. Electronic address: parmstro@ualberta.ca.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.008']
3186,33040573,Reflective testing - A randomized controlled trial in primary care patients.,"BACKGROUND


Reflective testing, i.e. interpreting, commenting on and, if necessary, adding tests in order to aid the diagnostic process in a meaningful and efficient manner, is an extra service provided by laboratory medicine. However, there have been no prospective randomized controlled trials investigating the value of reflective testing in patient management.
METHODS


In this trial, primary care patients were randomly allocated to an intervention group, where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group, where general practitioners only received the laboratory test results requested. Patients' medical records were evaluated with a follow-up period of six months. For both groups, the primary outcome measures, i.e. both intended action and actual management action, were blindly assessed by an independent expert panel as adequate, neutral or inadequate.
RESULTS


In 226 of the 270 cases (84%), reflective testing was considered to be useful for the patient. In the intervention group ( n  = 148), actual management by the general practitioner was scored as adequate ( n  = 104; 70%), neutral ( n  = 29; 20%) or not adequate ( n  = 15; 10%). In the control group ( n  = 122), these numbers were 57 (47%), 37 (30%) and 28 (23%). This difference was statistically significant ( P  < 0.001).
CONCLUSION


This randomized controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.",2020,"This difference was statistically significant (p<0.001).CONCLUSIONThis randomised controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.","['primary care patients', 'primary care patients Running head', '226 of the 270 cases (84']","['intervention group where general practitioners received laboratory tests results as requested as well as add-on test results with interpretative comments where considered appropriate by the laboratory specialist, or to a control group where general practitioners only received the laboratory test results requested']",['intended action and actual management action'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1292787', 'cui_str': 'Management - action'}]",,0.0973084,"This difference was statistically significant (p<0.001).CONCLUSIONThis randomised controlled trial showed a positive effect of reflective testing in primary care patients on the adequacy of their management, as documented in medical records.","[{'ForeName': 'Wytze P', 'Initials': 'WP', 'LastName': 'Oosterhuis', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Centre, Heerlen/Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Wilhelmine Phg Verboeket-van de', 'Initials': 'WPV', 'LastName': 'Venne', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Centre, Heerlen/Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Cees Tbm van', 'Initials': 'CTV', 'LastName': 'Deursen', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Centre, Heerlen/Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Henri Ejh', 'Initials': 'HE', 'LastName': 'Stoffers', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Bernadette Ac van', 'Initials': 'BAV', 'LastName': 'Acker', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Centre, Heerlen/Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Patrick Mm', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, the Netherlands.'}]",Annals of clinical biochemistry,['10.1177/0004563220968373']
3187,33048342,The effect of remote ischaemic preconditioning on endothelial function after hip fracture surgery.,"BACKGROUND


Endothelial dysfunction seems to play a role in the pathophysiology of myocardial injury after surgery. The aim of this randomised clinical trial was to examine whether remote ischaemic preconditioning in relation to hip fracture surgery ameliorates post-operative systemic endothelial dysfunction.
METHODS


This was a planned single-centre pilot sub-study of a multicentre, randomised clinical trial. Patients ≥45 years with a cardiovascular risk factor were randomised to remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation with their hip fracture operation. RIPC consisted of four cycles of 5 minutes forearm ischaemia and reperfusion. The procedure was performed non-invasively with a tourniquet. The endothelial function was assessed with non-invasive digital pulse amplitude tonometry on post-operative day 1 and expressed as the reactive hyperaemia index (RHI). Endothelial dysfunction was defined as RHI < 1.22.
RESULTS


Between February 2015 and December 2016, 18 patients were allocated to the RIPC group and 20 patients to the control group. The endothelial function was impaired in both groups on post-operative day 1. RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, P = .76. Endothelial dysfunction was present in 3/18 patients (16.7%) in the RIPC group and 8/20 patients (40%) in the control group, P = .11.
CONCLUSION


No beneficial effect of remote ischaemic preconditioning on the systemic endothelial dysfunction, assessed at a single time point on post-operative day one, was detected after hip fracture surgery.",2020,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","['Patients ≥ 45 years with a cardiovascular risk factor', 'Between February 2015 and December 2016', 'after hip fracture surgery', '18 patients were allocated to the RIPC group and 20 patients to the control group']","['remote ischaemic preconditioning', 'remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation to their hip fracture operation']","['Endothelial dysfunction', 'systemic endothelial dysfunction', 'reactive hyperaemia index (RHI', 'RHI', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",18.0,0.0816998,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ekeloef', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ossian', 'Initials': 'O', 'LastName': 'Gundel', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Falkenberg', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13724']
3188,33048421,"Tasmannia lanceolata leaf extract alleviates stretch mark appearance in a randomized, placebo-controlled clinical trial in women and stimulates extracellular matrix synthesis in ex vivo human skin explants.","BACKGROUND


The leaves of Tasmannia lanceolata mainly contain polygodial that is known to exhibit a range of biological functions including anti-inflammatory effects.
AIMS


These studies aimed to assess the effects of Tasmannia lanceolata extract (TLE) on skin and more particularly on stretch marks in women.
PATIENTS/METHODS


A double-blind, randomized, placebo-controlled clinical study was carried out on 29 women, aged from 25 to 60 years, to investigate the effects of TLE on stabilized stretch marks. TLE and placebo products were topically applied daily for 8 weeks. Skin roughness and firmness of stretch marks were assessed by 2D and 3D photograph processing and analyses. Dermal density and thickness were evaluated using ultrasound, while stretch mark conditions (length, color, and depth) were determined by clinical scoring. Matricial proteins (pro-collagen I and elastin) and pro-matricial factors, like TGF-β concentrations, were quantified from cultures of human skin explants presenting stretch marks, treated with TLE or vehicle control.
RESULTS


Skin roughness of stretch marks was significantly reduced in the TLE group after 8 weeks of treatment. Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment, and this improved effect was maintained until the end of the study. Dermal density and thickness were significantly increased in the TLE group compared to the placebo group. Furthermore, TLE restored the dermal condition of the stretch mark skin, up to normal skin levels. In addition, pro-collagen I and elastin concentrations were found to be higher in the TLE-treated stretch mark skin explants compared to the untreated ones, associated with higher quantities of TGF-β production.
CONCLUSION


These results revealed that TLE could help improve the aspect of stabilized stretch marks in women by restoring the matricial environment.",2020,Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment and this improved effect was maintained until the end of the study.,"['women', '29 women, aged from 25 to 60 years']","['TLE or vehicle control', 'TLE and placebo', 'placebo', 'TLE', 'Tasmannia lanceolata extract (TLE']","['Skin firmness of stretch marks', 'elastin concentrations', 'Skin roughness of stretch marks', 'Dermal density and thickness', 'Skin roughness and firmness of stretch marks']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0013765', 'cui_str': 'Elastin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",29.0,0.063414,Skin firmness of stretch marks was significantly increased in the TLE group after 4 weeks of treatment and this improved effect was maintained until the end of the study.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Gaillard', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boisnic', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Branchet', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Lamour', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Mayoura', 'Initials': 'M', 'LastName': 'Keophiphath', 'Affiliation': 'D.I.V.A. Expertise, Toulouse, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13780']
3189,33045536,Laser tongue debridement for oral malodor-A novel approach to halitosis.,"STUDY OBJECTIVE


Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. We hypothesize that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.
METHODS


A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, Halimeter reading, tongue colors changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.
RESULTS


54 patients recruited with 35 available for follow up. Improvement was observed on all objective and QOL subjective parameters. Treatment was tolerated well with minimal discomfort.
CONCLUSIONS


The tongue is proven to be a major contributor to oral malodor and must be addressed in treatment protocol. LTD significantly reduces malodor by subjective and objective criteria. While impossible to determine whether the tongue serves as a bacterial reservoir or is the origin for oral bacteria it is clear that LTD improves oral hygiene and reduces malodor. LTD is safe and easy to perform. We encourage LTD to be a crucial part of any oral malodor treatment protocol.
TRIAL REGISTRATION


clinical trials, NCT04120948. Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e.",2020,Improvement was observed on all objective and QOL subjective parameters.,"['Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e', '54 patients recruited with 35 available for follow up']","['laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser', 'LTD', 'Laser tongue debridement for oral malodor']","['objective and QOL subjective parameters', 'oral hygiene and reduces malodor']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1289836', 'cui_str': 'Solid-state laser device'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",54.0,0.0383094,Improvement was observed on all objective and QOL subjective parameters.,"[{'ForeName': 'Yosef P', 'Initials': 'YP', 'LastName': 'Krespi', 'Affiliation': 'Northwell Health, United States of America. Electronic address: ykrespi1@northwell.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kizhner', 'Affiliation': ""Mount Sinai St. Luke's, United States of America.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Wilson', 'Affiliation': 'Northwell Health, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Sivriver', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Khosravi', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stoodley', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102458']
3190,33045627,Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndrome.,"OBJECTIVES


Percutaneous radiofrequency denervation of the medial dorsal branch is often used for treatment of chronic low back pain originating from intervertebral facets, which is sometimes associated with a low success rate and a higher incidence of recurrence of pain. We theorized that implementing pulsed radiofrequency treatment to dorsal root ganglion would increase the probability of successful pain relief.
PATIENTS AND METHODS


150 patients diagnosed with CLBP of a confirmed facet origin were included in a prospective randomized controlled trial and were randomly divided into three equal groups, the first was submitted to percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment. Local injection of a mixture of local anesthetic and a steroid was given to the three groups. Cases were followed for a maximum of 3 years.
RESULTS


98 (65.3 %) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63). At 2 years' follow-up, the pulsed radiofrequency treatment of the dorsal root ganglia group maintained significant improvement (p= 0.041) whereas the medial branch denervation group lost its significant effect (p=0.32).By the end of follow-up period, only pulsed radiofrequency treatment of the dorsal root ganglia group kept significant improvement (p=0.044).
CONCLUSION


In CLBP of facet origin, pulsed radiofrequency treatment of the dorsal root ganglia provides both a higher incidence as well as an extended period of pain relief compared to radiofrequency ablation of the medial dorsal branch of the facet joint.",2020,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","['lumbar facet syndrome', '98 (65.3 %) patients were females', '150 patients diagnosed with CLBP of a confirmed facet origin']","['percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment', 'Percutaneous pulsed radiofrequency treatment of dorsal root ganglion', 'mixture of local anesthetic and a steroid']","['VAS', 'probability of successful pain relief']","[{'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.0175157,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","[{'ForeName': 'Wael Mohamed', 'Initials': 'WM', 'LastName': 'Moussa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelmmosa@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khedr', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelkhedr2000@yahoo.com.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Elsawy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, El Menia University, Korneesh El Nil, El Menia, Egypt. Electronic address: medhatelsawy73@yahoo.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106253']
3191,33047325,The Coping with and Caring for Infants with Special Needs intervention was associated with improved motor development in preterm infants.,"AIM


We compared the impact of standard infant physiotherapy and the family-centred programme, Coping with and Caring for Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions.
METHODS


This randomised controlled trial was carried out in patients' homes and outpatient settings in Switzerland between January 2016 and October 2019. We used data from the national SwissNeoNet register and an assessment battery that included infant and family outcomes and video analyses of therapy sessions. The Infant Motor Profile was the primary outcome instrument.
RESULTS


The COPCA group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30), and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31). COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval: 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval: 4.1-20.6) domains than standard care participants. COPCA coaching was positively associated with IMP scores at 18 months, but some standard care actions were negatively associated.
CONCLUSION


COPCA was associated with better motor outcome in infants born before 32 weeks than standard infant physiotherapy.",2020,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","['preterm infants', 'Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions', 'group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30) and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31', ""patients' homes and outpatient settings in Switzerland between January 2016 and October 2019""]","['COPCA coaching', 'COPCA', 'standard infant physiotherapy and the family-centred programme, Coping With and Caring']","['IMP scores', 'IMP variation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.179955,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","[{'ForeName': 'Schirin', 'Initials': 'S', 'LastName': 'Akhbari Ziegler', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Rhein', 'Affiliation': 'Department of Pediatrics, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Meichtry', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wirz', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Tjitske', 'Initials': 'T', 'LastName': 'Hielkema', 'Affiliation': 'Department of Pediatrics, Division of Developmental Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mijna', 'Initials': 'M', 'LastName': 'Hadders-Algra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pediatrics, Division of Developmental Neurology, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15619']
3192,33047696,The effects of using phase-contrast microscopy on oral hygiene training of patients receiving orthodontic treatment: A randomized controlled study.,"Objective


To investigate of effects of using phase-contrast video technique on education in oral hygiene training. This one blind, parallel randomized controlled trial was conducted in a tertiary clinic. Fifty-three patients who presented to the orthodontics department aged 12-20 years were divided into two groups randomly by computer-generated assigned codes to receive oral hygiene education. The participants were blinded to type of education method. Before orthodontic therapy, the control group was trained only by the conventional method, while the test group was trained by phase-contrast video microscopy method in addition to conventional method. Some images and videos of moving microorganisms in dental plaque were shown to the patients in test group on a computer monitor.
Subjects and Methods


The bacterial count, plaque index, and gingival index scores were compared. Measurements were obtained in baseline and follow-ups which were repeated with 1-month intervals after the training.
Results


The plaque index scores (1.05 ± 0.1 vs. 1.43 ± 0.2; P < 0.001) and gingival index scores (0.90 ± 0.1 vs. 1.14 ± 0.2; P < 0.001) in test group was statistically lower than those in control group at the end of the study. The gingival index scores reduced by 39% in test group vs. 14% in control group. The number of bacteria significantly decreased in the group trained with phase-contrast video microscope technique (8,059,133 ± 3016 vs. 10,830,600 ± 4919; 0.018).
Conclusions


The training with phase-contrast microscopy has a more positive effect than the traditional method in oral hygiene education.",2020,The gingival index scores reduced by 39% in test group vs. 14% in control group.,"['Fifty-three patients who presented to the orthodontics department aged 12-20 years', 'Subjects and Methods', 'patients receiving orthodontic treatment']","['computer-generated assigned codes to receive oral hygiene education', 'phase-contrast video technique']","['plaque index scores', 'bacterial count, plaque index, and gingival index scores', 'number of bacteria', 'gingival index scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0026024', 'cui_str': 'Phase contrast microscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",53.0,0.0280386,The gingival index scores reduced by 39% in test group vs. 14% in control group.,"[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Koca', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Acikgöz', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dundar', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kirtiloglu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University, Samsun, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_365_19']
3193,33052491,Effect of a 6-week and 12-week cardiac rehabilitation program on heart rate recovery.,"BACKGROUND


Cardiac rehabilitation has been shown to reduce cardiac mortality, improve quality of life, and reduce hospitalizations. Cardiac rehabilitation programs are usually performed over a 12-week period. Studies have shown that similar benefits could be achieved with shorter programs. Abnormal heart rate recovery after exercise has been associated with an increased risk of cardiovascular events and mortality. The main aim of this study was to compare the effect of a 6-week phase 2 cardiac rehabilitation program on heart rate recovery to a 12-week one in patients who had recovered from an anterior wall ST segment elevation myocardial infarction.
RESULTS


This prospective study included 60 patients enrolled in cardiac rehabilitation programs randomized into two equal groups: a 6-week and a 12-week program. Baseline patient demographics, lipid profile, and left ventricular ejection fraction (LVEF) were assessed. METs achieved, total exercise time, resting heart rate, peak heart rate, and heart rate recovery at 1 min were examined. These were re-assessed at the end of each program. Results showed no difference between both groups at the end of each program regarding lipid profile and LVEF. Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program. Heart rate recovery was slightly higher in patients enrolled in the 6-week program 26.5 ± 6.78 versus 23.17 ± 6.12 bpm (p = 0.051). On comparing the magnitude of change between both programs, those in the 12-week program had more increase in HDL-C levels, METs achieved, and exercise time. Additionally, they had more reduction of resting heart rate. Heart rate recovery was more increased for those in the 6-week program.
CONCLUSION


Although heart rate recovery increases after completion of each of a 6-week and 12-week cardiac rehabilitation program compared to their baseline, there is no difference on comparing heart rate recovery between both programs at their end. Patients enrolled in a standard 12-week cardiac rehabilitation program achieve more METs, have a longer exercise time, a higher peak HR, and a lower resting HR at the end of the program compared to those in the 6-week program.",2020,"Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program.","['60 patients enrolled in cardiac rehabilitation programs', 'patients who had recovered from an anterior wall ST segment elevation myocardial infarction']",['cardiac rehabilitation program'],"['HDL-C levels, METs achieved, and exercise time', 'Baseline patient demographics, lipid profile, and left ventricular ejection fraction (LVEF', 'cardiac mortality', 'total exercise time, resting heart rate, peak heart rate, and heart rate recovery', 'resting heart rate', 'Heart rate recovery', 'lipid profile and LVEF', 'heart rate recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.0115637,"Patients enrolled in the 12-week cardiac rehabilitation program were able to achieve more METs, had a longer exercise time, a higher peak heart rate, and had a lower resting heart rate at the end of the program.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Missiri', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. amissiri@med.asu.edu.eg.'}, {'ForeName': 'Sameh Atteya', 'Initials': 'SA', 'LastName': 'Amin', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Islam Reda', 'Initials': 'IR', 'LastName': 'Tawfik', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Adel Mohamed', 'Initials': 'AM', 'LastName': 'Shabana', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00107-8']
3194,33052539,Inhaler Technique and Self-reported Adherence to Medications Among Hospitalised People with Asthma and COPD.,"BACKGROUND


Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Inhaler technique is important since incorrect technique can lead to a poorer prognosis and hospitalization.
OBJECTIVE


The objective of this study was to investigate the inhaler technique and overall adherence to medications in an adult population with asthma and COPD.
PATIENTS AND METHODS


Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission. Inhaler technique was assessed using checklists and observations with placebo-inhalers were conducted. The Medication Adherence Report Scale (MARS)-5 was used to measure self-reported overall adherence to drug medication.
RESULTS


Of the 23 people included in the study, 26.1% had one or more critical errors in inhaler technique and 30.4% were considered overall non-adherent to drug medication. Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
CONCLUSION


This study indicates that poor inhaler technique and overall non-adherence to medications occur among hospitalised people with asthma and COPD living in northern Sweden. Interventions to improve inhaler technique and adherence to drugs are needed.",2020,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","['asthma and chronic obstructive pulmonary disease (COPD', 'hospitalised people with asthma and COPD living in northern Sweden', 'adult population with asthma and COPD', 'Hospitalised People with Asthma and COPD', 'Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission']",[],[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",[],[],,0.0436148,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden. maria.gustafsson@umu.se.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00210-x']
3195,33044421,"The ""PalliActive Caregivers"" Intervention for Caregivers of Patients With Cancer in Palliative Care: A Feasibility Pilot Study.","This pilot study aimed to assess the feasibility and possible effects of the ""PalliActive Caregivers,"" nursing intervention, on the uncertainty in illness and quality of life of family caregivers of patients with cancer receiving palliative care. This pilot study used a randomized controlled design. The participants were 80 family caregivers. The experimental group received the novel ""PalliActive Caregivers"" intervention. Data were collected using a sociodemographic form, the Uncertainty in Illness Scale, the Quality of Life scale, and an Intervention satisfaction questionnaire. The caregivers who received the intervention ""PalliActive Caregivers"" reported a high degree of satisfaction (9.74 on a 10-point scale). The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010). It is recommended that future studies using the ""PalliActive Caregivers"" intervention examine the effects on other variables such as the burden of patient's symptoms, caregiver burden and rewards, self-efficacy in symptom management, competence, unmet needs, and satisfaction with care.",2020,"The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010).","['Caregivers of Patients With Cancer in Palliative Care', 'patients with cancer receiving palliative care', 'participants were 80 family caregivers']","['PalliActive Caregivers,"" nursing intervention', 'novel ""PalliActive Caregivers"" intervention', 'PalliActive Caregivers"" Intervention']","['Quality of Life scale, and an Intervention satisfaction questionnaire', 'psychological well-being of quality of life', 'uncertainty regarding illness']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",80.0,0.0393185,"The intervention showed a significant decrease in uncertainty regarding illness in the experimental group (P = .009), as well as a significant decrease in the psychological well-being of quality of life within the experimental and control groups, before and after the intervention (P = .013, P = .010).","[{'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arias-Rojas', 'Affiliation': 'Mauricio Arias-Rojas, PhD, MSc, RN, is assistant professor, Faculty of Nursing, Universidad de Antioquia, Medellin, Colombia. Sonia Carreño-Moreno, PhD, is associate Professor, Faculty of Nursing, Universidad Nacional de Colombia, Bogotá, Colombia. Natalia Arias-Quiroz, RN, is research assistant, Faculty of Nursing, Universidad de Antioquia, Medellin, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Carreño-Moreno', 'Affiliation': ''}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Arias-Quiroz', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000696']
3196,33044435,Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality.,"INTRODUCTION


Previous studies have observed an inverse relationship between exercise and breast cancer risk. However, there is inter-individual variability in response to exercise training interventions. We investigated whether increasing the dose of aerobic exercise (150 min·week or 300 min·week), while keeping intensity of exercise constant (70%-80% HRmax), decreases the number of exercise non-responders, and further decreases associated-risk for cancer mortality in our study population of women genetically pre-disposed for breast cancer.
METHODS


Healthy premenopausal women at elevated risk of breast cancer were randomized into control (<75 min·week, n=47), low-dose exercise (150 min·week, n=39), and high-dose exercise groups (300 min·week, n=39) for approximately six months. We assessed: 1) clinical effectiveness (CE), defined as an improvement in predicted VO2max of ≥1 mL·kg·min, and, twice the typical error (2x TE) of VO2max, as thresholds to classify exercise ""non-responders""; 2) CE and 2x TE relative to exercise adherence levels, and 3) related changes in VO2max to predicted cancer mortality risk.
RESULTS


Following our six month intervention we observed 23.5% of women in the low-dose group and 5.6% of women in the high-dose group were clinical non-responders (p=0.04). Clinical non-responder status was independent of adherence level Associated reduction in risk for cancer mortality was observed among 87.2% of women in the low-dose group and 94.9% in the high dose group (p=0.43).
CONCLUSION


Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"". True non-responders were observed as some women did not improve their fitness capacity despite high exercise adherence levels. Lastly, it appears 150 min·week is sufficient to decrease predicted risk of cancer mortality.",2020,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".",['Healthy premenopausal women at elevated risk of breast cancer'],"['low-dose exercise', 'aerobic exercise (150 min·week or 300 min·week), while keeping intensity of exercise constant (70%-80% HRmax', 'Exercise']","['predicted VO2max of ≥1 mL·kg·min, and, twice the typical error (2x TE) of VO2max, as thresholds to classify exercise ""non-responders""; 2) CE and 2x TE relative to exercise adherence levels, and 3) related changes in VO2max to predicted cancer mortality risk', 'clinical effectiveness (CE', 'risk of cancer mortality', 'risk for cancer mortality', 'Cancer Mortality']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",,0.0490609,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Potiaumpai', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002539']
3197,33039944,"Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.","BACKGROUND


Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5-6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS.
METHODS


ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose.
RESULTS


From November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab.
CONCLUSION


The rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5-6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material.",2020,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","['patients with relapsing-remitting multiple sclerosis', 'patients with early-stage relapsing-remitting MS', 'From November 1, 2018, to December 13, 2019, 745 patients']","['ocrelizumab', 'PLUS', 'conventional or shorter infusion group']","['total site stay', 'total site stay time', 'proportion of patients with infusion-related reactions (IRRs', 'rates and severity of IRRs', 'Adverse events', 'serious, life-threatening, or fatal', 'IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",745.0,0.20051,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","[{'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany. Electronic address: hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, Medical University of Vienna, Währinger Gürtel 18-20 1090 Vienna, Austria.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for MS, Neurological Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH44195, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'INSERM U 1215, Neurocentre Magendie, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Carroll', 'Affiliation': 'Department of Neurology, Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands 6009, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Department of Neurology, Akershus University Hospital, PO Box 1000, 1478 Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Karabudak', 'Affiliation': 'Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Killestein', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nos', 'Affiliation': ""Centre d'Esclerosi Mútiple de Catalunya (Cemcat), Vall d'Hebron Hospital Universitari, 08035, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Neuroscience Section and Multiple Sclerosis Center, University of Catania PO Policlinico G Rodolico, Via Santa Sofia, 78 95123 Catania - Italy.'}, {'ForeName': 'A Perrin', 'Initials': 'AP', 'LastName': 'Ross', 'Affiliation': 'Loyola University Chicago, Chicago, Maywood, IL 60660, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vanopdenbosch', 'Affiliation': 'Department of Neurology, AZ Sint Jan Brugge Oostende, Ruddershove 10, 8000, Brugge, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vollmer', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, 12631 East 17th St, Mail Stop B 182, Aurora, Colorado 80045, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Buffels', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kadner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102492']
3198,33045193,Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial.,"BACKGROUND


In sub-Saharan Africa, home-based HIV testing is validated and accepted, but coverage is low because household members are often absent during home-based testing campaigns. We aimed to measure the effect of a secondary distribution of oral-fluid HIV self-tests on coverage during home-based testing in rural Lesotho.
METHODS


The Home-Based Self-Testing (HOSENG) trial was a cluster-randomised, non-blinded superiority trial in rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong). Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older. The HOSENG trial provided a recruitment platform for the interlinked Village-Based Refill of Antiretroviral Therapy (VIBRA) trial. Villages were randomly assigned 1:1:1:1 with block sizes of four to one of four groups: VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention. Randomisation was stratified by district, village size, and access to the nearest health facility. An independent statistician was responsible for the computer-generated randomisation list. In the intervention group, oral-fluid HIV self-tests were left for absent or declining household members (aged ≥12 years) during a home visit from the HIV testing campaign team. One present household member was trained on self-test use. Distributed self-tests were followed up by village health workers. In control village clusters, absent or declining household members were referred to the clinic for HIV testing. The primary outcome was HIV testing coverage among all household members aged 12 years or older within 120 days, defined as a confirmed HIV test result or known status, reported in testing registers at the health facilities or on the follow-up forms of the village health worker. Adjusted random-effects logistic regression with individuals as the unit of analysis was used. This trial is registered with ClinicalTrials.gov, NCT03598686.
FINDINGS


Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members). In the control group, 38 (3%) of 1455 initially absent or declining household members tested at a clinic within 120 days. In the intervention group, 841 (53%) of 1601 initially absent or declining household members had a confirmed status within 120 days; 12 (1%) of 841 tested at the clinic and 829 (99%) used their self-test kit. This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
INTERPRETATION


Secondary distribution of oral-fluid HIV self-tests during home-based testing increases testing coverage substantially and thus presents a promising add-on during testing campaigns.
FUNDING


Swiss National Science Foundation.",2020,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","['Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members', 'rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong', 'rural Lesotho', 'Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older']","['oral-fluid HIV self-tests', 'VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention']",['HIV testing coverage'],"[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.134167,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thabo Ishmael', 'Initials': 'TI', 'LastName': 'Lejone', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lefu', 'Initials': 'L', 'LastName': 'Khesa', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mathebe', 'Initials': 'M', 'LastName': 'Kopo', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Kao', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Katleho', 'Initials': 'K', 'LastName': 'Tlali', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'University of Basel, Basel, Switzerland; Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: n.labhardt@swisstph.ch.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30233-2']
3199,33045195,Circulating profile of Activin-Follistatin-Inhibin Axis in women with hypothalamic amenorrhea in response to leptin treatment.,"BACKGROUND


Chronic energy deficiency observed in women that exercise strenuously affects reproductive function, often leading to hypothalamic amenorrhea (HA). In such conditions, hypoleptinemia and robust changes in the Activin-Follistatin-Inhibin Axis (AFI) are observed. Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance. In this work, we aimed to identify differences in hormonal profiles between leptin responders and non-responders among women with HA, with particular focus on the AFI axis.
METHODS


AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ) were measured in blood in: a) An open-label interventional study, b) a randomized placebo-controlled trial, both investigating responders versus non-responders/women with HA treated with leptin.
RESULTS


Women with HA that responded to leptin treatment have higher circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio and a trend to lower AMH compared with non-responders.
CONCLUSIONS


Components of the AFI axis are associated with improvement of reproductive function in women with HA treated with leptin. ΑΜΗ may serve as a marker of ovarian recovery under HA treatment.",2020,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","['women with HA, with particular focus on the AFI axis', 'responders versus non-responders/women with HA treated with leptin', 'women with HA treated with leptin', 'women with hypothalamic amenorrhea in response to leptin treatment']",['placebo'],"['circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio', 'reproductive function', 'AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}]",,0.0378645,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Bouzoni', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA. Electronic address: ebouzoni@bidmc.harvard.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA; Section of Endocrinology, VA Boston Healthcare System, Jamaica Plain, MA, USA.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154392']
3200,33046213,Dopaminergic and opioidergic regulation during anticipation and consumption of social and nonsocial rewards.,"The observation of animal orofacial and behavioral reactions has played a fundamental role in research on reward but is seldom assessed in humans. Healthy volunteers (N = 131) received 400 mg of the dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo. Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards were assessed. Both drugs resulted in lower physical effort and greater negative facial reactions during reward anticipation, especially of food rewards. Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption. Subjective ratings of wanting and liking were not modulated by either drug. Results suggest that facial reactions during anticipated and experienced pleasure rely on partly different neurochemical systems, and also that the neurochemical bases for food and touch rewards are not identical.",2020,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,['Healthy volunteers (N = 131'],"['dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo', 'naltrexone']","['Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards', 'positive facial reactions', 'Subjective ratings of wanting and liking', 'lower physical effort and greater negative facial reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242702', 'cui_str': 'Dopamine receptor antagonist'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0526814,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Department of Psychology, University of Essex, Colchester, United Kingdom.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Götzendorfer', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sezen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Graf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthäus', 'Initials': 'M', 'LastName': 'Willeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}]",eLife,['10.7554/eLife.55797']
3201,33047586,[Appendectomy technique: paradigm shift or a well-forgotten old one? The role of mesoappendectomy in prevention of infectious intra-abdominal complications (announcement of RCT)].,"OBJECTIVE


To analyze the role of mesoappendixectomy in the development of intra-abdominal surgical site infection (IAB SSI) after LAE.
MATERIAL AND METHODS


A prospective randomized non-blind multiple-center registered (ClinicalTrials.gov NCT03754777) study has been performed for the period from 2016 to 2018. The study was devoted to effectiveness and safety of the modified enhanced recovery protocol in LAE. In the main group, this protocol ( n =56) included routine mesoappendixectomy, restrictive strategy for abdominal drainage and postoperative antibiotic prevention. In the control group ( n =71), mesoappendixectomy was performed only in case of necrotic changes. Both groups were comparable by demographic parameters and severity of comorbidities.
RESULTS


In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%). Moreover, the main group was characterized by reduced length of hospital-stay (1.43±1.34 d versus 2.94±2, 43 days).
CONCLUSION


Mesoappendixectomy should be evaluated in further research as a potential factor in prevention of IAB SSI.",2020,"In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%).",[],"['mesoappendectomy', 'mesoappendixectomy', 'routine mesoappendixectomy, restrictive strategy for abdominal drainage and postoperative antibiotic prevention']","['reduced length of hospital-stay', 'incidence of IAB SSI', 'demographic parameters and severity of comorbidities']",[],"[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0412978,"In the main group, significant decrease in the incidence of IAB SSI was found (0% versus 9.8%).","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sazhin', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Nechay', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Titkova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Petukhov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stradymov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Ermakov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Mishakina', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202010149']
3202,33047588,[Risk factors of abdominal wound dehiscence in abdominal surgery].,"OBJECTIVE


To evaluate the role of various perioperative risk factors on the incidence of abdominal wound dehiscence.
MATERIAL AND METHODS


A retrospective controlled randomized trial of the risk factors of abdominal wound dehiscence was conducted in 62 patients for the period 2013- 2018. The research was performed at the Perm City Clinical Hospital No. 4. All patients were divided into two groups: the main one ( n =31) with abdominal wound dehiscence in early postoperative period and the control group ( n =31) without this event. Both groups were comparable by gender, age and surgical abdominal diseases. Between-group differences in numerical indicators were analyzed using Mann-Whitney U-test, qualitative variables were analyzed using contingency tables. Differences were significant at  p -value <0.05.
RESULTS


Incidence of abdominal wound dehiscence was similar in patients who admitted in emergency and elective fashion ( p =0.54). Anemia upon admission ( p =0.71), diabetes mellitus type 2 ( p =1.00), COPD ( p =0.13) and obesity ( p =0.76) were not significant predictors of abdominal wound dehiscence. There were significant between-group differences in CRP level ( p =0.04). Among intraoperative risk factors, duration of surgery ( p =0.78), surgical approach ( p =1.00), aponeurosis suturing technique ( p =0.39) and stoma ( p =0.71) did not significantly affect the incidence of abdominal wound dehiscence. In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
CONCLUSION


Despite the variety of pre-, intra- and postoperative risk factors, only infectious postoperative complications (SSI, peritonitis) and redo surgical interventions influenced the development of abdominal wound dehiscence. Thus, the concept of abdominal wound dehiscence prevention should be inextricably associated with the concept of prevention of postoperative infectious complications from the abdominal wall and abdominal cavity.",2020,"In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
","['abdominal surgery', '62 patients for the period 2013- 2018']",[],"['redo laparotomy', 'Anemia upon admission', 'aponeurosis suturing technique', 'abdominal wound dehiscence', 'diabetes mellitus type 2', 'abdominal wound dehiscence correlated with peritonitis', 'COPD', 'SSI', 'incidence of abdominal wound dehiscence', 'CRP level']","[{'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0225205', 'cui_str': 'Aponeurosis structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1739397', 'cui_str': 'Abdominal wound dehiscence'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",31.0,0.0224269,"In early postoperative period, abdominal wound dehiscence correlated with peritonitis ( p =0.04), SSI ( p <0.01) and redo laparotomy ( p =0.02).
","[{'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Samartsev', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Gavrilov', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Kuznetsova', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kuznetsova', 'Affiliation': 'Wagner Perm State Medical University, Perm, Russia.'}]",Khirurgiia,['10.17116/hirurgia202010168']
3203,33048053,Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial.,"BACKGROUND


Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.
OBJECTIVE


The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.
METHODS


An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.
RESULTS


Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).
CONCLUSIONS


This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.",2020,Between-group analysis showed no significant difference for any outcome measure at,"['43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain', 'Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23', 'Adults With Chronic Temporomandibular Disorder Pain', 'patients with chronic temporomandibular pain', 'chronic temporomandibular pain']","['dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles', 'Internet-Based Multimodal Pain Program With Telephone Support', 'occlusal splint therapy', 'internet-based multimodal pain program and occlusal splint therapy', 'conventional occlusal splint therapy', 'internet-based multimodal pain program']","['characteristic pain intensity', 'jaw functional limitation score', 'chronic temporomandibular disorder pain', 'pain-related disability', 'characteristic pain intensity, pain-related disability, and jaw functional limitation', 'degree of depression', 'jaw function limitation', 'anxiety', 'depression, anxiety, catastrophizing, and stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",20.0,0.131671,Between-group analysis showed no significant difference for any outcome measure at,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lam', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Alstergren', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmö, Sweden.'}]",Journal of medical Internet research,['10.2196/22326']
3204,33048056,"Effects of Acute Exercise on Drug Craving, Self-Esteem, Mood, and Affect in Adults with Polysubstance Use Disorder: Protocol for a Multicenter Randomized Controlled Trial.","BACKGROUND


Novel treatments for substance use disorders are needed. Acute bouts of exercise can improve mood states and craving in nonclinical populations. Exercise effects in those with polysubstance dependence are understudied; controlled trials are needed.
OBJECTIVE


This protocol describes a clinical study examining the short-term psychological effects of 2 types of physical activity, soccer and circuit training, in patients with substance use disorders. Effects will be compared with a nonexercise control group. Specific aims are to investigate whether there are differences between the activities and the duration of changes.
METHODS


This study is a short-term multicenter randomized control trial with a crossover design. Patients consecutively admitted to 4 inpatient treatment centers were invited to participate in 3 conditions, each lasting 45 minutes, within one week. The order of the conditions was randomized. There were a total of 5 assessments, taken at baseline, immediately before each condition, immediately after each condition, and 1, 2, and 4 hours postintervention, enabling patterns of change over time to be observed. Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood. Exercise intensity was assessed with the Borg Rating of Perceived Exertion scale and a heart rate monitor (Polar M200; Polar Electro Ltd). Cortisol was assessed in saliva before and 4 hours after the intervention.
RESULTS


A total of 39 patients were included in the study. Data collection was completed in 2019.
CONCLUSIONS


We anticipate larger improvements in the intervention groups than among controls, indicating positive psychological effects during and after exercise. The study will add clinically relevant information about the short-term psychological effects of exercise in the treatment of substance use disorders, using activities that are easily accessible in different clinical settings.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00018869; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018869.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18553.",2020,"Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood.","['Patients consecutively admitted to 4 inpatient treatment centers', 'A total of 39 patients were included in the study', 'Adults with Polysubstance Use Disorder', 'patients with substance use disorders', 'nonclinical populations']","['physical activity, soccer and circuit training', 'Acute Exercise']","['Cortisol', 'Exercise intensity', 'Drug Craving, Self-Esteem, Mood', 'Exercise effects', 'Psychological effects', 'self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood', 'Borg Rating of Perceived Exertion scale and a heart rate monitor (Polar M200; Polar Electro Ltd']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}]",39.0,0.188736,"Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood.","[{'ForeName': 'Maren Mikkelsen', 'Initials': 'MM', 'LastName': 'Ellingsen', 'Affiliation': 'Department for Inpatient Treatment of Substance Misuse, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sunniva Launes', 'Initials': 'SL', 'LastName': 'Johannesen', 'Affiliation': 'Department for Inpatient Treatment of Substance Misuse, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Egil Wilhelm', 'Initials': 'EW', 'LastName': 'Martinsen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sandra Rinne', 'Initials': 'SR', 'LastName': 'Dahl', 'Affiliation': 'Hormone Laboratory, Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR research protocols,['10.2196/18553']
3205,33048057,Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
OBJECTIVE


The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect the implementation and effectiveness of the intervention.
METHODS


A mixed methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses data from a smartphone-based telemonitoring system with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semistructured interviews with a purposive sample of clinicians and patients.
RESULTS


Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to be completed by the winter of 2021.
CONCLUSIONS


This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring and its impact on patient health outcomes. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19705.",2020,"Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
","['patients with heart failure (HF', 'Patients With Heart Failure', 'semistructured interviews with a purposive sample of clinicians and patients', 'Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group', 'enroll 108 patients']","['GDMT', 'Remote Titration Combined With Telemonitoring', 'Guideline-directed medical therapy (GDMT', 'smartphone-based telemonitoring system']","['survival rates', 'burden of hospitalization, and increase survival rates', 'health care outcomes', 'HF symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",76.0,0.114959,"Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Artanian', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ross', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seto', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",JMIR research protocols,['10.2196/19705']
3206,33048059,AQUEDUCT Intervention for Crisis Team Quality and Effectiveness in Dementia: Protocol for a Feasibility Study.,"BACKGROUND


Specialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver.
OBJECTIVE


The aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual.
METHODS


This is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures.
RESULTS


Ethical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial.
CONCLUSIONS


There is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18971.",2020,This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia.,"['54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia', 'teams managing crisis in dementia', 'people with dementia who experience crisis', 'Dementia', 'older people with dementia', 'Using Crisis Teams']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],,0.127553,This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia.,"[{'ForeName': 'Emma Elizabeth', 'Initials': 'EE', 'LastName': 'Broome', 'Affiliation': 'National Institute for Health Research Nottingham Biomedical Research Centre, Hearing Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Donna Maria', 'Initials': 'DM', 'LastName': 'Coleston-Shields', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dening', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Stanyon', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR research protocols,['10.2196/18971']
3207,33052131,Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial.,"BACKGROUND


Promoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother's health and well-being, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation).
OBJECTIVE


The primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD values for the outcome measures to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions.
METHODS


Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies and the participants' engagement and adherence to the interventions. We will also assess the experiences of women in each of the 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews.
RESULTS


This project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
CONCLUSIONS


If the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19803.",2020,"Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
","['pregnant women', 'Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age', 'Pregnancy']","['full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation', 'full-scale RCT', 'RCT protocol', 'Web-Based Mindfulness With Loving-Kindness and Compassion Training']","['psychological distress', 'risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.127455,"Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
","[{'ForeName': 'Amy Louise', 'Initials': 'AL', 'LastName': 'Finlay-Jones', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jacqueline Ann', 'Initials': 'JA', 'LastName': 'Davis', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Keerthi', 'Initials': 'K', 'LastName': 'Kottampally', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Rebecca Anne', 'Initials': 'RA', 'LastName': 'Ashley', 'Affiliation': 'Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jeneva Lee', 'Initials': 'JL', 'LastName': 'Ohan', 'Affiliation': 'University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Downs', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}]",JMIR research protocols,['10.2196/19803']
3208,33049188,Impact of catheter size on pain and continence following robotic prostatectomy.,"INTRODUCTION Continence and catheter related pain following prostatectomy are significant patient concerns, and it is unknown whether catheter size impacts these variables. In this study, patients undergoing prostatectomy were randomized to receive either a 16 French or 20 French catheter to assess the impact of catheter size on postoperative continence and pain.
MATERIALS AND METHODS


Patients were prospectively randomized to receive either a 16 French or a 20 French latex catheter at the completion of prostatectomy. Subjects were asked on postoperative day 7 to report their average catheter-related pain and the amount of opioid medication used. International Prostate Symptom Score, Quality of Life score and pads per day were recorded 6 and 12 weeks postoperatively.
RESULTS


Fifty-two patients were randomized. Seven were excluded: surgeon catheter preference (3) or withdrawal of consent (4). Demographic and pathologic data did not differ between groups (all p > 0.20). Catheter pain scores and postoperative opioid use were not different between groups (all p > 0.78). Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
CONCLUSIONS


Catheter size did not impact postoperative urethral and bladder pain or continence prostatectomy. These data suggest that surgeon preference should guide catheter selection between 16-20 French. Future studies might investigate precise intraoperative anastomosis size measurement and the impact of catheter size on pain scores in a nonoperative population.",2020,"Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
","['Patients', 'Seven were excluded: surgeon catheter preference (3) or withdrawal of consent (4', 'Fifty-two patients were randomized', 'patients undergoing prostatectomy']","['robotic prostatectomy', '20 French latex catheter at the completion of prostatectomy', 'catheter size', '16 French or 20 French catheter']","['pain and continence', 'Postoperative subjective urinary symptom scores, and pads per day', 'Catheter pain scores and postoperative opioid use', 'Demographic and pathologic data', 'postoperative urethral and bladder pain or continence prostatectomy', 'pain scores', 'International Prostate Symptom Score, Quality of Life score and pads per day']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449963', 'cui_str': 'Size of catheter'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0232849', 'cui_str': 'Bladder pain'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",52.0,0.0632527,"Postoperative subjective urinary symptom scores, and pads per day did not differ between groups at both 6 and 12 weeks (all p > 0.16).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stamm', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Ferenczi', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kozlowski', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Corman', 'Affiliation': ''}]",The Canadian journal of urology,[]
3209,33049927,Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial.,"Background:  Nursing staff working in the operating room are exposed to risk factors that can cause musculoskeletal disorders (MSDs) and work-related disabilities. The use of ergonomics principles can help with the prevention of MSDs. This study aimed to examine the effect of an ergonomics educational program on MSDs among nursing staff working in the operating room.  Methods:  In this pragmatic parallel group quasi-randomized controlled clinical trial, 74 nursing staff working in the operating rooms of two teaching hospitals participated. The hospitals were randomly assigned to either the intervention or the control group and all nursing staff working in the operating room of each hospital were invited to take part in this research. They were initially assessed for the prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist. The intervention group received the ergonomics educational program and were assessed in two-week intervals over a period of three months. At the end of the study, the risk and prevalence of MSDs were compared between the intervention and control groups.  Results:  Statistically significant differences were reported between the groups in terms of the prevalence and risk of MSDs. The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03). The reduction in the prevalence of MSDs in the different parts of the body in the intervention group was as follows: ankle ( p  = 0.005), hand/wrist ( p  = 0.041), low back ( p  = 0.000), the neck ( p  = 0.003), hip ( p  = 0.001) and shoulder ( p  = 0.043).  Conclusion:  The education of nursing staff about ergonomics can influence the prevalence and risk of MSDs. Therefore, it should be incorporated into the degree education and on-the-job training initiatives for nurses working in the operating theatre in order to reduce workplace injuries and associated absences, and increase the quality of care delivered by them. This clinical trial has been registered in the Iranian Registry of Clinical Trials: IRCT2015081823677N1.",2020,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"['74 nursing staff working in the operating rooms of two teaching hospitals participated', 'Musculoskeletal Disorders in Nursing Staff Working in the Operating Room']","['control group and all nursing staff working', 'Ergonomics Educational Program', 'ergonomics educational program']","['prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist', 'risk and prevalence of MSDs', 'prevalence and risk of MSDs', 'prevalence of MSDs', 'overall risk of MSDs']","[{'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0268263', 'cui_str': 'Multiple sulfatase deficiency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",74.0,0.0344032,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Abdollahi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Shadan', 'Initials': 'S', 'LastName': 'Pedram Razi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Pahlevan', 'Affiliation': 'Social Determinants of Health Research Centre, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran 1417613151, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Amaniyan', 'Affiliation': 'Student Research Center, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leibold Sieloff', 'Affiliation': 'College of Nursing, Montana State University, Bozeman, MT 172220, USA.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17197333']
3210,33049973,Effect of Added Sugar on the Consumption of A Lipid-Based Nutrient Supplement Among 7-24-Month-Old Children.,"Small-quantity lipid-based nutrient supplements (SQ-LNS) could help prevent malnutrition. Our primary objective was to examine the acceptability and consumption of sweetened and unsweetened versions of SQ-LNS before and after 14-days of repeated exposure. A total of 78 mother-infant dyads recruited from health centers in Morelos, Mexico, were randomized to two groups of SQ-LNS (sweetened, LNS-S; unsweetened, LNS-U). During the study, infants were fed SQ-LNS (20 g) mixed with 30 g of complementary food of the caregiver's choice. The amount of supplement-food mixture consumed was measured before, during and after a 14-day home exposure period. We defined acceptability as consumption of at least 50% of the offered food mixture. At initial exposure, LNS-U consumption was on average 44.0% (95% CI: 31.4, 58.5) and LNS-S 34.8% (25.3, 44.0); at final exposure, LNS-U and LNS-S consumption were 38.5% (27.8, 54.0) and 31.5% (21.6, 43.0). The average change in consumption did not differ between the groups (2.2 p.p. (-17.2, 24.4)). We conclude that the acceptability of sweetened and unsweetened SQ-LNS was low in this study population. Since consumption did not differ between supplement versions, we encourage the use of the unsweetened version given the potential effects that added sugar may have on weight gain especially in regions facing the double burden of malnutrition.",2020,The average change in consumption did not differ between the groups (2.2 p.p.,"['78 mother-infant dyads recruited from health centers in Morelos, Mexico', '7-24-Month-Old Children']","['Small-quantity lipid-based nutrient supplements (SQ-LNS', 'Added Sugar', 'SQ-LNS']","['acceptability and consumption of sweetened and unsweetened versions of SQ-LNS', 'average change in consumption', 'LNS-U consumption']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}]",,0.147884,The average change in consumption did not differ between the groups (2.2 p.p.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Institute of Global Nutrition, Department of Nutrition, University of California, Davis, 3135 Meyer Hall, One Shields Avenue, Davis, CA 95616, USA.'}, {'ForeName': 'Amado D', 'Initials': 'AD', 'LastName': 'Quezada-Sánchez', 'Affiliation': 'Center for Evaluation and Surveys Research, National Institute of Public Health, Avenida Universidad, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, School of Medicine, University of Colorado Anschutz Medical Campus, East 17th Place Mail Stop C225, Aurora, CO 80045, USA.'}, {'ForeName': 'Cloe', 'Initials': 'C', 'LastName': 'Rawlinson', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Pacheco-Miranda', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Venosa López', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Gonzalez Navarrete', 'Affiliation': 'Global Alliance for Improved Nutrition, Rue de Vermont 37-39, 1202 Genève, Switzerland.'}, {'ForeName': 'Anabelle Bonvecchio', 'Initials': 'AB', 'LastName': 'Arenas', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}]",Nutrients,['10.3390/nu12103069']
3211,33050038,The Role of the Teacher in the Implementation of a School-Based Intervention on the Physical Activity Practice of Children.,"Medium- or long-term intervention strategies for physical activity practice (PAP) need to be more effective in terms of their implementation by practitioners. The aim of this study was to evaluate the role of a teacher to implement the Team Pentathlon (TP) in order to improve the PAP in primary children. TP is a health education program made to improve PAP of children through individual and collective achievements. In this study, 203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions. Levels of PAP (self-reported) were compared between groups (IG/CG), sex, socioeconomic status of the schools and between teachers: baseline and during TP. Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP. One teacher even observed higher PAP in the CG. Training session records revealed that the teacher himself, how the TP is implemented, and proper resources were the three elements that explained the successful implementation of the TP program. The implementation of the TP significantly increased the PAP in primary children. Training sessions helped teachers to implement the TP program but personal engagement, motivation, respecting protocol, and an adequate environment are also necessary in improving the PAP of children.",2020,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","['primary children', 'Children', '203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were']","['guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions', 'Team Pentathlon (TP']","['Levels of PAP (self-reported', 'PAP']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0870482', 'cui_str': 'Elementary School Teachers'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205450', 'cui_str': '4'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",203.0,0.0103558,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","[{'ForeName': 'Tegwen', 'Initials': 'T', 'LastName': 'Gadais', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Caron', 'Affiliation': ""Faculté des Sports et de l'EP, Université d'Artois, 62800 Liévin, France.""}, {'ForeName': 'Marie-Belle', 'Initials': 'MB', 'LastName': 'Ayoub', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Karelis', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Nadeau', 'Affiliation': 'Department of Physical Education, Laval University, Quebec City, QC G1V 0A6, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17197344']
3212,33061398,Effect of Switching from Low-Dose Simvastatin to High-Dose Atorvastatin on Glucose Homeostasis and Cognitive Function in Type 2 Diabetes.,"Background


High-intensity statin is recommended in high-risk type 2 diabetes (T2D); however, statin dose dependently increases the risk of developing new-onset diabetes, can potentially worsen glycemic control in T2D, and may cause cognitive impairment. This study aimed to investigate the effect of statin intensification on glucose homeostasis and cognitive function in T2D.
Materials and Methods


T2D patients who were taking simvastatin ≤20 mg/day were randomized to continue taking the same dosage of simvastatin (low-dose simvastatin group; LS, n=63) for 12 weeks, or to change to atorvastatin 40 mg/day for 6 weeks, and if tolerated, atorvastatin was increased to 80 mg/day for 6 weeks (high-dose atorvastatin group; HS, n=62). Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT) were assessed at baseline, 6 weeks, and 12 weeks.
Results


Mean age of patients was 58.8±8.9 years, and 72% were female. Mean baseline FPG and HbA 1c  were 124.0±27.5 mg/dl and 6.9±0.8%, respectively. No differences in baseline characteristics between groups were observed. Change in HbA 1c  from baseline in the LS and HS groups was -0.1% and +0.1% ( p =0.03) at 6 weeks, and -0.1% and +0.1% ( p =0.07) at 12 weeks. There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
Conclusion


Switching from low-dose simvastatin to high-dose atorvastatin in T2D resulted in a slight increase in HbA 1c  (0.1%) without causing cognitive decline.",2020,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","['≤20 mg/day', 'T2D.\nMaterials and Methods\n\n\nT2D patients who were taking', 'Mean age of patients was 58.8±8.9 years, and 72% were female', 'Type 2 Diabetes']","['\n\n\nHigh-intensity statin', 'simvastatin (low-dose simvastatin', 'atorvastatin', 'Switching from Low-Dose Simvastatin to High-Dose Atorvastatin', 'simvastatin', 'statin intensification']","['Change in HbA 1c', 'Glucose Homeostasis and Cognitive Function', 'Mean baseline FPG and HbA 1c', 'FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT', 'Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT', 'glucose homeostasis and cognitive function']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",,0.0177678,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","[{'ForeName': 'Nuntakorn', 'Initials': 'N', 'LastName': 'Thongtang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthakan', 'Initials': 'N', 'LastName': 'Tangkittikasem', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kittichai', 'Initials': 'K', 'LastName': 'Samaithongcharoen', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jirasak', 'Initials': 'J', 'LastName': 'Piyapromdee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varalak', 'Initials': 'V', 'LastName': 'Srinonprasert', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sutin', 'Initials': 'S', 'LastName': 'Sriussadaporn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Vascular health and risk management,['10.2147/VHRM.S270751']
3213,33058401,Improving parents' knowledge of early signs of paediatric eye disease: A double-blind randomized controlled trial.,"IMPORTANCE


Educating parents to recognize signs of eye disease and consult a healthcare professional is critical to timely diagnosis, intervention and outcomes.
BACKGROUND


We evaluate the effectiveness of an eye-health information pamphlet on parents' level of concern and help-seeking intention should they hypothetically observe leukocoria or strabismus in their child.
DESIGN


Double-blind, randomized controlled trial conducted at a metropolitan antenatal outpatient clinic.
PARTICIPANTS


In total, 518 pregnant women were enrolled in the study.
METHODS


After completing a study-specific, pre-test survey describing hypothetical clinical scenarios at baseline, participants were randomly assigned to receive a pamphlet on either paediatric eye health (intervention) or infant play (control). The post-test survey was sent by email 2 weeks after baseline.
MAIN OUTCOME MEASURES


A change in the parents' level of concern if they observed leukocoria or strabismus and a change in their help-seeking intention if they hypothetically observed leukocoria or strabismus in their child.
RESULTS


Of the 518 women, 382 (73.7%) completed the post-test survey. At follow-up, women who received the intervention were more likely to report a higher level of concern if they observed leukocoria (OR 1.711 [CI: 1.176-2.497] P = .005]) and were less likely to delay help-seeking (OR 0.560 [CI 0.382-0.817] P = .003). No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] P = .016).
CONCLUSION AND RELEVANCE


Providing parents with relevant, evidence-based information can significantly improve their knowledge and positively influence help-seeking intentions if leukocoria or strabismus are observed.",2020,"No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] p=0.016).
","['Of the 518 women, 382 (73.7%) completed the post-test survey', '518 pregnant women were enrolled in the study', 'metropolitan antenatal outpatient clinic']","['eye-health information pamphlet', 'pamphlet on either paediatric eye health (intervention) or infant play (control']","['level of concern if they observed leukocoria', 'level of concern for strabismus', 'delay help-seeking']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0152458', 'cui_str': 'Leukocoria'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]",518.0,0.345538,"No change in the level of concern for strabismus was identified between the groups; however, at follow-up, women who received the intervention were less likely to delay help-seeking (OR 0.318 [CI 0.125-0.806] p=0.016).
","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Staffieri', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gwyneth', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Sanfilippo', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': ""Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mackey', 'Affiliation': ""Lion's Eye Institute, Centre for Ophthalmology and Visual Sciences, University of Western Australia, Perth, Australia.""}, {'ForeName': 'Alex W', 'Initials': 'AW', 'LastName': 'Hewitt', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13866']
3214,33058419,Evaluation of pain intensity in patients treated with aligners and conventional fixed appliances: Randomized clinical trial.,"OBJECTIVE


This randomized clinical trial aimed to compare the pain intensity in patients treated with orthodontic aligners and conventional fixed appliances.
SETTING AND SAMPLE POPULATION


This study was a randomized clinical trial. The sample comprised 39 patients randomly allocated into 2 groups: OA (orthodontic aligners, n = 20) and FA (Fixed Appliance, n = 19).
MATERIAL AND METHODS


The pain intensity was measured by the visual analogue scale (VAS) in the following periods: T0 (baseline), T1 (seven days after appliance placement) and seven days after each return on the first (T2), third (T3) and sixth (T4) months. The following variables were also investigated in the baseline: conditioned pain modulation, anxiety levels, hypervigilance and catastrophizing. The VAS measurements between groups were compared by the Mann-Whitney test. Comparisons between periods within each group were performed by the Friedman test. Data regarding catastrophizing and hypervigilance were compared by the t test. All tests were applied at a significance level of 5%, with 95% confidence interval.
RESULTS


Both groups presented similar levels of anxiety, hypervigilance, catastrophizing and conditioned pain modulation. Both groups did not differ concerning the pain intensity in all periods. The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation; however, at the 6-month period (T4), the pain levels varied over these days without statistical difference. Higher levels of pain were observed in the first seven days after appliance placement.
CONCLUSION


The pain intensity, usually mild, was not influenced by the appliance design, although different patterns of reported pain seem to occur between groups.",2020,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","['patients treated with aligners and conventional fixed appliances', 'patients treated with orthodontic aligners and conventional fixed appliances']","['OA (orthodontic aligners, n=20) and FA (Fixed Appliance, n=19']","['visual analogue scale (VAS', 'VAS measurements', 'pain modulation, anxiety levels, hypervigilance and catastrophizing', 'pain levels', 'Higher levels of pain', 'pain intensity', 'anxiety, hypervigilance, catastrophizing and conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",39.0,0.140197,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","[{'ForeName': 'Cleomária Evelyn Vieira Freire', 'Initials': 'CEVF', 'LastName': 'Casteluci', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Paula Vanessa Pedron', 'Initials': 'PVP', 'LastName': 'Oltramari', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Paulo César Rodrigues', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, Bauru Orofacial Pain Group, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Rigoldi', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, Bauru Orofacial Pain Group, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida-Pedrin', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Thaís Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Marcio Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'de Castro Ferreira Conti', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12431']
3215,33059105,Topical use of tranexamic acid versus epinephrine to optimise surgical field during exploratory tympanotomy.,"OBJECTIVE


To explore the effect of diluting tranexamic acid as 1000 mg versus epinephrine as 1 mg in a volume of 200 mL of normal saline used for local washing and rinsing of the used gauze at the surgical bleeding sites during microscopic ear surgeries.
METHODS


In a randomised, double-blind trial, sixty patients scheduled for elective microscopic exploratory tympanotomy consented to participate after meeting the inclusion criteria. Patients assigned using the balanced block randomisation method into two similar groups; one received tranexamic acid (TXA), and the other received epinephrine. The outcome of the study focused on blood pressure, heart rate, quality of surgical field assessed via Boezaart score, the volume of bleeding, and the incidence of complications.
RESULTS


The more prominent findings were the statistically significant and favourable surgical field assessment according to the Boezaart score, and lower estimates of bleeding demonstrated in the TXA group compared to the epinephrine group, along the time of the study P-value was < 0.05. The haemodynamic monitoring showed promising changes in the TXA group compared with the epinephrine group in terms of lower mean blood pressure and lower heart rate that reached the level of statistical significance during the time of the study.
CONCLUSION


the use of topical tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.",2020,"the use of topical Tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.",['sixty patients scheduled for elective microscopic exploratory tympanotomy consented to participate after meeting the inclusion criteria'],"['epinephrine', 'Tranexamic acid (TXA', 'diluting Tranexamic acid', 'tranexamic acid versus epinephrine', 'topical Tranexamic acid', 'TXA']","['mean blood pressure and lower heart rate', 'bleeding', 'blood pressure, heart rate, quality of surgical field assessed via Boezaart score, the volume of bleeding, and the incidence of complications']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",60.0,0.0997517,"the use of topical Tranexamic acid during microscopic ear surgeries is associated with a better surgical field, less bleeding, and favourable haemodynamic parameters compared to epinephrine.","[{'ForeName': 'Rasha A', 'Initials': 'RA', 'LastName': 'Hamed', 'Affiliation': 'Anaesthesiology Department, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: rashaahmed11@aun.edu.eg.'}, {'ForeName': 'Esam M', 'Initials': 'EM', 'LastName': 'Hamed', 'Affiliation': 'Lecturer of Anaesthesia, ICU and Pain Management, Assiut University, Assiut, Egypt.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.08.008']
3216,33065060,Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial.,"BACKGROUND


Sodium-glucose co-transporter 2 inhibitors might enhance erythropoiesis and increase red blood cell mass. We assessed the long-term effects of canagliflozin on anaemia-related outcomes.
METHODS


In a post-hoc analysis of the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, we included patients with type 2 diabetes and chronic kidney disease who were randomly assigned to treatment with canagliflozin or placebo at 690 sites in 34 countries. We assessed the effects of canagliflozin versus matched placebo on haemoglobin and haematocrit using linear mixed-effects models. The primary outcome of this post-hoc analysis was a composite outcome of investigator-reported anaemia or treatment for anaemia, which was assessed using Kaplan-Meier analysis and Cox regression models. All analyses were done by intention to treat.
FINDINGS


Between March 24, 2014, and May 5, 2017, 4401 participants were randomly assigned to receive canagliflozin (100 mg; n=2202) or placebo (n=2199). At baseline, mean haemoglobin concentration was 132·0 g/L (SD 17·7), 1599 (36%) of 4401 participants had anaemia (defined as haemoglobin <130 g/L in men or <120 g/L in women), and 33 (<1%) of 4401 participants used erythropoiesis-stimulating agents. During a median follow-up period of 2·6 years (IQR 2·1-3·1), mean haemoglobin concentration was 7·1 g/L (95% CI 6·4-7·8) higher and haematocrit was 2·4% (2·2-2·6) higher in the canagliflozin group than the placebo group. Overall, 573 of 4401 participants had either an investigator-reported anaemia event or initiation of treatment for anaemia: 358 (8%) of 4401 participants reported anaemia events, 343 (8%) initiated iron preparations, 141 (3%) initiated erythropoiesis-stimulating agents, and 114 (2%) received blood transfusion. The risk of the composite outcome of anaemia events or initiation of treatment for anaemia was lower in the canagliflozin group than the placebo group (hazard ratio 0·65, 95% CI 0·55-0·77; p<0·0001). Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
INTERPRETATION


These data suggest that canagliflozin reduces the risk of anaemia-associated outcomes, including the need for erythropoiesis-stimulating agents, among patients with type 2 diabetes and chronic kidney disease.
FUNDING


Janssen Research and Development.",2020,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","['0·65', 'patients with type 2 diabetes and chronic kidney disease', 'Between March 24, 2014, and May 5, 2017, 4401 participants']","['canagliflozin', 'canagliflozin or placebo', 'placebo']","['haematocrit', 'lower risks of anaemia events', 'haemoglobin and haematocrit', 'composite outcome of investigator-reported anaemia or treatment for anaemia', 'anaemia', 'mean haemoglobin concentration', 'anaemia event or initiation of treatment for anaemia', 'blood transfusion', 'anaemia events or initiation of treatment for anaemia', 'anaemia events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",4401.0,0.640331,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Concord Repatriation General Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; The Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30300-4']
3217,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: A randomized clinical trial.,"OBJECTIVE


Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output.
DESIGN AND METHODS


We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapagliflozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP).
RESULTS


24-h urinary excretion of DEHP and MEHP was increased (+44%, p = 0.036; +49%, p = 0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p = 0.016; +36%, p = 0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-h urinary sodium (r = 0.42, p = 0.0226) and potassium (r = 0.54, p = 0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r = 0·43, p = 0.0205; r = 0·44, p = 0.0168 respectively) but not to potassium.
CONCLUSIONS


Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2020,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316']
3218,33065358,Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial.,"BACKGROUND


Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care.
OBJECTIVE


To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results.
PARTICIPANTS AND SETTING


Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program.
METHODS


Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis.
RESULTS


A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training.
CONCLUSIONS


Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.",2020,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","['Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program', 'Total population sampling with qualitative data collection methods']",['Fostering Changes program'],[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}]","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0305087,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: Scourfield@cardiff.ac.uk.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104768']
3219,33065408,Biomarker-enhanced VTE risk stratification in ambulatory patients with cancer.,"INTRODUCTION


Risk assessment models are used to stratify cancer patients according to their underlying risk of VTE. The CATS score has been shown to enhance VTE risk stratification as compared to the modified Khorana score by incorporating d-dimer and soluble p-selectin measurements. Our aim was to evaluate the performance of the CATS score with respect to VTE risk stratification.
MATERIALS AND METHODS


Analysis of a subset of the AVERT trial population for whom biomarker data was available. All patients included in the AVERT trial were at increased risk of VTE based on a modified Khorana score of ≥2. Patients were stratified according to the modified Khorana score and CATS score. Kaplan-Meier analysis was used to calculate the 6-month cumulative probabilities of VTE.
RESULTS


A total of 466 patients were included in the analysis, 229 and 237 patients in the placebo and apixaban arms, respectively. The 6-month cumulative probability of VTE among patients with a modified Khorana score ≥ 3 was 13% [95% CI 7 to 23], whereas it was 20% [95% CI 11 to 35] for patients with a CATS score ≥ 4. The absolute risk reduction achieved with apixaban VTE prophylaxis among patients with modified Khorana ≥2, modified Khorana ≥3 and CATS ≥4 was -5.9% [-10.9 to -0.8], -5.8% [-16.0 to 4.5] and -10.1% [-22.9 to 2.6], respectively. Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
CONCLUSIONS


The use of a CATS score of ≥4 to identify ambulatory cancer patients at very high risk of VTE could enhance the benefit/risk ratio achieved with apixaban VTE prophylaxis.",2020,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","['ambulatory patients with cancer', 'ambulatory cancer patients at very high risk of VTE', 'Analysis of a subset of the AVERT trial population for whom biomarker data was available', '466 patients were included in the analysis, 229 and 237 patients in the']",['placebo and apixaban'],"['risk of bleeding events', '6-month cumulative probability of VTE', 'modified Khorana or CATS scores', 'modified Khorana score and CATS score', 'risk of VTE']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",466.0,0.0562162,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: pwells@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.035']
3220,33047468,"Response to Eriksson et al A randomized, controlled trial comparing the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.",,2020,Optimizing protection from pneumococcal disease among high-risk patients is paramount and many countries have recommendations for solid organ transplant recipients to receive pneumococcal vaccines.,"['renal transplant patients', 'kidney transplant recipients']",['23-valent pneumococcal polysaccharide vaccination'],"['immunogenicity and safety', 'safety and immunogenicity']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.0733964,Optimizing protection from pneumococcal disease among high-risk patients is paramount and many countries have recommendations for solid organ transplant recipients to receive pneumococcal vaccines.,"[{'ForeName': 'Rachel Souza', 'Initials': 'RS', 'LastName': 'Dawson', 'Affiliation': 'Global Medical and Scientific Affairs (Vaccines), Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Feemster', 'Affiliation': 'Global Medical and Scientific Affairs (Vaccines), Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'E David G', 'Initials': 'EDG', 'LastName': 'McIntosh', 'Affiliation': 'MSD, UK.'}, {'ForeName': 'Ulrike K', 'Initials': 'UK', 'LastName': 'Buchwald', 'Affiliation': 'Global Clinical Development, Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13493']
3221,33050753,Effects of sevoflurane and propofol anesthesia on intraoperative endothelial cell function in patients undergoing laparoscopic cholecystectomy.,"OBJECTIVES


To investigate the effects of sevoflurane and propofol anesthesia on inflammatory or anti-inflammatory responses in patients undergoing laparoscopic cholecystectomy (LC).
METHODS


Patients undergoing LC (n = 23) were divided into sevoflurane (S) (n = 11) and propofol (P) (n = 12) anesthesia groups. A blood sample was taken before induction (T0), after induction but before pneumoperitoneum (T1), 15 minutes after pneumoperitoneum (T2), immediately after extubation (T3), and 30 minutes after extubation (T4). P-selectin-positive platelets and intercellular cell adhesion molecule-1 (ICAM-1)-positive lymphocytes, and plasma P-selectin, ICAM-1 and thrombomodulin (TM) levels were analyzed.
RESULTS


Sevoflurane significantly increased P-selectin expression in platelets at T2, T3, and T4 and in plasma at T1, T2, T3, and T4, but it did not affect ICAM-1 and TM. Propofol had no significant effects on P-selectin, ICAM-1, and TM expression during anesthesia and surgery. P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
CONCLUSIONS


Propofol anesthesia can delay the inflammatory reactions during laparoscopic surgery and better maintain the structure stability and function in vascular endothelial cells.",2020,"P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
","['patients undergoing laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy (LC', 'Patients undergoing LC (n\u2009=\u200923']","['sevoflurane and propofol anesthesia', 'sevoflurane (S) (n\u2009=\u200911) and propofol (P) (n\u2009=\u200912) anesthesia groups', 'Propofol anesthesia', 'Sevoflurane', 'Propofol']","['intraoperative endothelial cell function', 'P-selectin expression', 'plasma P-selectin, ICAM-1 and thrombomodulin (TM) levels', 'inflammatory or anti-inflammatory responses', 'P-selectin, ICAM-1, and TM expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",,0.0458643,"P-selectin, ICAM-1, and TM expression was higher in the S compared with P group at T1, T2, and T3 for platelet P-selectin; T2 and T4 for plasma P-selectin; T1 and T2 for lymphocyte ICAM-1; and T1, T2, and T3 for plasma TM.
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520918407']
3222,33052122,"Costing and Cost-Effectiveness of a Mobile Health Intervention (ImTeCHO) in Improving Infant Mortality in Tribal Areas of Gujarat, India: Cluster Randomized Controlled Trial.","BACKGROUND


During 2013, a mobile health (mHealth) program, Innovative Mobile Technology for Community Health Operation (ImTeCHO), was launched in predominantly tribal and rural communities of Gujarat, India. ImTeCHO was developed as a job aid for Accredited Social Health Activists (ASHAs) and staff of primary health centers to increase coverage of maternal, neonatal, and child health care.
OBJECTIVE


In this study, we assessed the incremental cost per life-years saved as a result of the ImTeCHO intervention as compared to routine maternal, neonatal, and child health care programs.
METHODS


A two-arm, parallel, stratified cluster randomized trial with 11 clusters (primary health centers) randomly allocated to the intervention (280 ASHAs, n=2,34,134) and control (281 ASHAs, n=2,42,809) arms was initiated in 2015 in a predominantly tribal and rural community of Gujarat. A system of surveillance assessed all live births and infant deaths in the intervention and control areas. All costs, including those required during the start-up and implementation phases, were estimated from a program perspective. Incremental cost-effectiveness ratios were estimated by dividing the incremental cost of the intervention with the number of deaths averted to estimate the cost per infant death averted. This was further analyzed to estimate the cost per life-years saved for the purpose of comparability. Sensitivity analysis was undertaken to account for parameter uncertainties.
RESULTS


Out of a total of 5754 live births (3014 in the intervention arm, 2740 in the control arm) reported in the study area, per protocol analysis showed that the implementation of ImTeCHO resulted in saving 11 infant deaths per 1000 live births in the study area at an annual incremental cost of US $163,841, which is equivalent to US $54,360 per 1000 live births. Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted. In a realistic environment with district scale-up, the program is expected to become even more cost-effective.
CONCLUSIONS


Overall, the findings of our study strongly suggest that the mHealth intervention as part of the ImTeCHO program is cost-effective and should be considered for replication elsewhere in India.
TRIAL REGISTRATION


Clinical Trials Registry of India CTRI/2015/06/005847; http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=11820&EncHid=&modid=&compid=%27,%2711820det%27.",2020,"Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted.","['5754 live births (3014 in the intervention arm, 2740 in the control arm', '11 clusters (primary health centers) randomly allocated to the intervention (280 ASHAs, n=2,34,134) and control (281 ASHAs, n=2,42,809) arms was initiated in 2015 in a predominantly tribal and rural community of Gujarat']",['Mobile Health Intervention'],"['live births and infant deaths', 'Incremental cost-effectiveness ratios']","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0740625,"Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted.","[{'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Modi', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Somen', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Gandhinagar, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Vaghela', 'Affiliation': 'Health & Family Welfare Department, Gujarat, Gandhinagar, India.'}, {'ForeName': 'Kapilkumar', 'Initials': 'K', 'LastName': 'Dave', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ''}, {'ForeName': 'Shrey', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Society for Education, Welfare and Action (SEWA) Rural, Bharuch, India.'}]",JMIR mHealth and uHealth,['10.2196/17066']
3223,33049424,The impact of prior and ongoing threat on the false alarm threshold for facial discrimination.,"BACKGROUND AND OBJECTIVES


Perceptual adaptations that facilitate rapid responses to threats can also lead to false alarms, or the failure to discriminate safe stimuli from signals of threat. We examined the impact of varying degrees of threat on false alarms in the perceptual discrimination of faces along the dimension of emotion (Experiment 1) or identity (Experiment 2).
METHODS


Participants first trained to discriminate between a target and nontarget face. Next, we tested their ability to identify the target in randomized presentations of the target, the nontarget, and nine novel stimuli morphed in 10% increments of similarity from the target to the nontarget. The task was completed under one of three randomized conditions: 1) Ongoing-Threat paired the target with an aversive outcome in both phases; 2) Prior-Threat paired the target with an aversive outcome in the training phase only; and 3) No-Threat paired the target with a neutral outcome in the training phase only.
RESULTS


In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat. In Experiment 2 (N = 90), Ongoing-Threat and Prior-Threat each lowered the false alarm threshold for identity-based discrimination compared to No-Threat.
LIMITATIONS


The experiment did not measure generalization of threat responses.
CONCLUSION


Associating a facial expression or identity with threat leads to faster but less accurate discrimination of faces with similar features, particularly under conditions of ongoing threat. These experiments provide an avenue for examining the parameters that impact false alarms, which play a key role in anxiety disorders.",2020,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.",['Participants first trained to discriminate between a target and nontarget face'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],[],,0.0222255,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'The University of Texas at Austin, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'The University of Texas at Austin, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101619']
3224,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND


Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS


Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS


Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS


Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
3225,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND


Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD


Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS


The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS


Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
3226,33050205,Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of  Helicobacter pylori : Randomized ERADICATE Hp Trial.,"Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for  Helicobacter pylori (H. pylori) . This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with  H. pylori  infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT  H. pylori  eradication rate (95% CI) with RHB-105 of 89.4% (82.0-96.8%) was greater than both the literature-derived comparator rate ( P  < 0.001) and the standard-of-care rate of 63.0% (44.8-81.1%) ( P  = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia ® ) proved to be a safe and effective empiric therapy for  H. pylori  eradication.",2020,"The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures.",['naïve adults with  H. pylori  infection and dyspepsia to RHB-105 (an all-in-one combination of'],"['omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo', 'Rifabutin-Containing Triple Therapy (RHB-105', 'RHB-105 (Talicia ® ']","['headache', 'diarrhea', 'leukopenia', 'standard-of-care rate', 'Adverse events', 'eradication rate', 'dizziness', 'abdominal tenderness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0992678', 'cui_str': 'Omeprazole 40 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0232498', 'cui_str': 'Abdominal tenderness'}]",,0.299334,"The  H. pylori  eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample  Z -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures.","[{'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant, M2g Consulting, 251 Central Park West, New York, NY 10024, USA.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, 2002 Holcombe Boulevard, Houston, TX 77030, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Riff', 'Affiliation': 'Anaheim Clinical Trials, 1085 N. Harbor Blvd, Anaheim, CA 92801, USA.'}, {'ForeName': 'Raymond M', 'Initials': 'RM', 'LastName': 'Panas', 'Affiliation': 'Medical Affairs, RedHill Biopharma, Inc., 8045 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100685']
3227,33050321,Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.,"Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up ( p  = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.",2020,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274).","['Cancer care centers', 'or usual care at eight French cancer institutions', '360 women with EBC who were receiving']","['Exercise and Diet', 'Supervised exercise dietary programs', 'Adapted Physical Activity Diet (APAD) education program', 'adjuvant chemotherapy and radiotherapy to APAD']","['general fatigue', 'fatigue', 'physical activity levels and dietary intake', 'general cancer-related fatigue score using the MFI-20 questionnaire', 'Fatigue']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",360.0,0.0467317,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p  = 0.274).","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Arnaud', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jarlier', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Eugène Marquis Center, Rue de la Bataille Flandres-Dunkerque, CS 44229, 35042 Rennes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Dalivoust', 'Affiliation': ""Ambroise Paré Hospital, 1 Rue de l'Eylau, 13006 Marseille, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Senesse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Azzedine', 'Affiliation': 'Montélimar Hospital, Quartier Beausseret, BP 249-26, 26216 Montélimar, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tredan', 'Affiliation': 'Léon Bérard Center, 28 Rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sadot-Lebouvier', 'Affiliation': 'René Gauducheau Center, Boulevard Jacques Monod, 44805 Saint-Herblain, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Mas', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Carayol', 'Affiliation': 'IAPS Laboratory ""Impact of Physical Activity on Health"", University of Toulon, Avenue de l\'Université, 83957 La Garde, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bleuse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Janiszewski', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Silene', 'Initials': 'S', 'LastName': 'Launay', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Lauridant', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Romieu', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ninot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Vanlemmens', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}]",Nutrients,['10.3390/nu12103081']
3228,33050325,Non-Surgical Periodontal Therapy with Adjunctive Amoxicillin/Metronidazole or Metronidazole When No  Aggregatibacter actinomycetemcomitans  Is Detected-A Randomized Clinical Trial.,"BACKGROUND


The aim was to compare two different systemic antibiotics regimens adjunctive to non-surgical periodontal therapy when  Aggregatibacter actinomycetemcomitans  was not detected in the subgingival biofilm.
METHODS


A total of 58 patients with periodontitis and with no  A. actinomycetemcomitans  in the subgingival biofilm were treated with full-mouth subgingival instrumentation and either metronidazole (MET;  n  = 29) or amoxicillin/metronidazole (AMX/MET;  n  = 29). Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP) were recorded at baseline, as well as after three and six months. Subgingival biofilm and gingival crevicular fluid were collected and analyzed for major periodontopathogens and biomarkers.
RESULTS


PD, CAL and BOP improved at 3 and 6 months (each  p  < 0.001 vs. baseline) with no difference between the groups. Sites with initial PD ≥ 6 mm also improved in both groups after 3 and 6 months ( p  < 0.001) with a higher reduction of PD in the AMX/MET group ( p  < 0.05). T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05). MMP-8 and IL-1β were without significant changes and differences between the groups.
CONCLUSION


When  A. actinomycetemcomitans  was not detected in the subgingival biofilm, the adjunctive systemic use of amoxicillin/metronidazole results in better clinical and microbiological outcomes of non-surgical periodontal therapy when the application of systemic antibiotics is scheduled.",2020,T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05).,['58 patients with periodontitis and with no  A. actinomycetemcomitans  in the subgingival biofilm'],"['amoxicillin/metronidazole', 'Amoxicillin/Metronidazole or Metronidazole', 'amoxicillin/metronidazole (AMX/MET', 'metronidazole']","['MMP-8 and IL-1β', 'Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP', 'T. forsythia', 'PD, CAL and BOP', 'Subgingival biofilm and gingival crevicular fluid']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",58.0,0.0764114,T. forsythia was lower in the AMX/MET group after 3 months ( p  < 0.05).,"[{'ForeName': 'Holger F R', 'Initials': 'HFR', 'LastName': 'Jentsch', 'Affiliation': 'Centre for Periodontology, Department of Cariology, Endodontology and Periodontology, University Hospital of Leipzig, Liebigstr. 12, Haus 1, D-04103 Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Private Dental Practice, Borngasse 12, D-99084 Erfurt, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, Laboratory of Oral Microbiology, School of Dental Medicine, University of Bern, Freiburgstr. 7, CH-3010 Bern, Switzerland.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100686']
3229,33050459,May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients?,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi. As a result, due to the destruction of nitric oxide ( • NO) by inflammatory superoxide (O 2 •- ), pulmonary  • NO concentration ceases, resulting in uncontrolled platelet aggregation and massive thrombosis, which kills the patients. Introducing  • NO by inhalation (INO) may replace the loss of endothelium-derived  • NO. The first results from clinical trials with INO in SARS-CoV-2 patients show a rapid and sustained improvement in cardiopulmonary function and decreased inflammation. An ongoing phase III study is expected to confirm the method's efficacy. INO may hence become a first line treatment in SARS-CoV-2 patients. However, due to the rapid inactivation of  • NO by deoxyhemoglobin to nitrate, pulmonary administration of  • NO will not protect remote organs. Another INO-related pharmacological approach to protect SARS-CoV-2 patients from developing life-threatening disease is to inhibit the O 2 •- -driven destruction of  • NO by neutralizing inflammatory O 2 •- . By making use of low molecular weight compounds that mimic the action of the enzyme manganese superoxide dismutase (MnSOD). The MnSOD mimetics of the so-called porphyrin type (e.g., AEOL 10150), salen type (e.g., EUK-8) and cyclic polyamine type (e.g., M40419, today known as GC4419 and avasopasem manganese) have all been shown to positively affect the inflammatory response in lung epithelial cells in preclinical models of chronic obstructive pulmonary disease. The Manganese diPyridoxyL EthylDiamine (MnPLED)-type mangafodipir (manganese dipyridoxyl diphosphate-MnDPDP), a magnetic resonance imaging (MRI) contrast agent that possesses MnSOD mimetic activity, has shown promising results in various forms of inflammation, in preclinical as well as clinical settings. Intravenously administration of mangafodipir will, in contrast to INO, reach remote organs and may hence become an important supplement to INO. From the authors' viewpoint, it appears logical to test mangafodipr in COVID-19 patients at risk of developing life-threatening SARS-CoV-2. Five days after submission of the current manuscript, Galera Pharmaceuticals Inc. announced the dosing of the first patient in a randomized, double-blind pilot phase II clinical trial with GC4419 for COVID-19. The study was first posted on ClinicalTrials.gov (Identifier: NCT04555096) 18 September 2020.",2020,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,['SARS-CoV-2 patients'],"['mangafodipir', 'magnetic resonance imaging (MRI']",['cardiopulmonary function and decreased inflammation'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0772321', 'cui_str': 'MANGAFODIPIR'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0324482,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,"[{'ForeName': 'Jan Olof G', 'Initials': 'JOG', 'LastName': 'Karlsson', 'Affiliation': 'Division of Drug Research/Pharmacology, Linköping University, SE-581 83 Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Jynge', 'Affiliation': 'Innlandet Trust Hospital, Gjøvik Hospital, NO-2819 Gjøvik, Norway.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Ignarro', 'Affiliation': 'Department of Pharmacology, UCLA School of Medicine, 264 El Camino Drive, Beverly Hills, CA 90212, USA.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100971']
3230,33050586,"The Effect of Fermented Porcine Placental Extract on Fatigue-Related Parameters in Healthy Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


Fatigue is one of the major health conditions induced by excessive stress or abnormal immune function or defective antioxidant systems. Placental extract has been reported to have various effects such as immune modulation and cellular regeneration. Fermented porcine placenta (FPP) is a safe nontoxic material, which is highly valuable as a functional food. The aim of this study was to investigate the anti-fatigue effects of FPP supplementation compared with a placebo product.
METHODS


In this double-blind, parallel, randomized, and placebo-controlled trial 84 healthy males and females, aged between 30 and 60 years were randomized to 320 mg of FPP once daily or placebo. The main outcome measures included efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered.
RESULTS


The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05). Cortisol levels were significantly improved in participants younger than 45 years following treatment with FPP compared with placebo. Furthermore, the lactate and myoglobin levels were improved significantly in participants with BMI ≥ 23 kg/m 2  ( p  = 0.045 and  p  = 0.011, respectively) following treatment with FPP versus placebo.
CONCLUSIONS


Our study showed that FPP supplementation significantly ameliorated fatigue-related parameters and subjective symptoms in healthy adults. Therefore, our results indicate that FPP supplementation induced anti-fatigue effect by regulating the inflammatory response.",2020,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05).,"['Healthy Adults', 'healthy adults', '84 healthy males and females, aged between 30 and 60 years']","['Fermented Porcine Placental Extract', 'FPP', 'FPP supplementation', 'placebo', 'placebo product', 'Fermented porcine placenta (FPP', 'Placebo', 'FPP once daily or placebo']","['Fatigue-Related Parameters', 'efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered', 'Cortisol levels', 'fatigue-related parameters and subjective symptoms', 'lactate and myoglobin levels', 'IL-1β mRNA expression and fatigue severity scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.700946,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p  < 0.05).,"[{'ForeName': 'Dong Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Ga-Young', 'Initials': 'GY', 'LastName': 'Han', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Su Seung', 'Initials': 'SS', 'LastName': 'Hwang', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Jin-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA 6027, Australia.'}, {'ForeName': 'Keunwon', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Jongbae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}]",Nutrients,['10.3390/nu12103086']
3231,33050630,Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial.,"The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.",2020,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","['Women with Fibromyalgia', '41 FM patients']","['mindfulness plus amygdala and insula retraining (MAIR', 'Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR', 'MAIR', 'MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual', 'relaxation therapy (RT']","['pain catastrophizing and psychological inflexibility', 'BDNF', 'BDNF levels', 'immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP', 'functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion', 'immune-inflammatory markers and brain-derived neurotrophic factor (BDNF', 'clinical severity and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",41.0,0.10071,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gasión', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Morillo-Sarto', 'Affiliation': 'Basic Psychology Department, Faculty of Psychology, University of Zaragoza, 44003 Teruel, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Colomer-Carbonell', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Tops', 'Affiliation': 'Developmental and Educational Psychology Unit, Leiden University, 233 AK Leiden, The Netherlands.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103246']
3232,33053245,Effect of shock wave therapy associated with aerobic exercise on cellulite: A randomized controlled trial.,"BACKGROUND


Cellulite is a multifactor and controversial condition. Several methods have been explored to reduce it, not always with favorable results. Shock Wave Therapy has been shown to be effective, but the results of its association with an Aerobic Exercise Program are unknown.
AIMS


To verify whether Shock Wave Therapy in association with an Aerobic Exercise Program reduces the degree of severity of Cellulite in the gluteal region and in the ⅓ of the proximal posterior of the thigh.
METHODS


Forty-five healthy women, aged from 18 to 32, randomly assigned, considering the severity degree in the Cellulite Severity Scale and the level of physical activity, in three groups: two experimental and one control group. The control group performed the evaluations. The experimental group 1 performed an Aerobic Exercise Program, and the experimental group 2 associated this program with a Radial Shock Wave Therapy protocol. The experimental groups completed six interventions within 3 weeks. In addition, the degree of severity in the Cellulite Severity Scale, height, body composition, skin temperature, and subcutaneous adipose tissue thickness were assessed. One-way ANOVA test and Kruskal-Wallis were used to obtain the results, with level of significance of 0.05.
RESULTS


Forty-two women completed the study. There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (P = 0.032), and from group 2 to the control group (P = 0.042).
CONCLUSION


The association of Shock Wave Therapy and Aerobic Exercise was shown to be effective in reducing the severity of cellulite.",2020,"There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (p=0.032), and from group 2 to the control group (p=0.042).
","['45 healthy women, aged from 18 to 32', 'cellulite', '42 women completed the study']","['Aerobic Exercise Program', 'aerobic exercise', 'shock wave therapy', 'Aerobic Exercise Program, and the experimental group 2 associated this program with a Radial Shock Wave Therapy protocol']","['severity of Cellulite', 'degree of severity in the Cellulite Severity Scale, height, body composition, skin temperature, and subcutaneous adipose tissue thickness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",45.0,0.0272538,"There was a significant reduction in the severity of Cellulite between experimental group 2 and group 1 (p=0.032), and from group 2 to the control group (p=0.042).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Troia', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Moreira', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pisco', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Noites', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Ana Luisa', 'Initials': 'AL', 'LastName': 'Vale', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Vilarinho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13791']
3233,33053431,"Medical assistant health coaching (""MAC"") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.","In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. ""Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching."" While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.",2020,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","['eligible patients at both health systems', 'individuals with diabetes. ', 'diabetes clinical control among N\u202f=\u202f600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California']","['Medical Assistant Health Coaching', 'MA health coaching versus usual care', 'Medical assistant health coaching (""MAC']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]",[],,0.0371121,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Fortmann.Adelaide@scrippshealth.org.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Euyoque.Johanna@scrippshealth.org.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tlclark@sdsu.edu.'}, {'ForeName': 'Daniela G', 'Initials': 'DG', 'LastName': 'Vital', 'Affiliation': 'San Diego State University Research Foundation, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: dvital@sdsu.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Sandoval.Haley@scrippshealth.org.'}, {'ForeName': 'Julia I', 'Initials': 'JI', 'LastName': 'Bravin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: jbravin-w@sdsu.edu.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Savin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: ksavin@sdsu.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jones', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Jones.Jennifer2@scrippshealth.org.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: sroesch@sdsu.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tgilmer@ucsd.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodenheimer', 'Affiliation': 'Department of Family and Community Medicine, University of California at San Francisco School of Medicine, 533 Parnassus Ave, San Francisco, CA 94143, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Neighborhood Healthcare, 460 N Elm St, Escondido, CA 92025, USA. Electronic address: jims@nhcare.org.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: lgallo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106164']
3234,33053622,Ticagrelor Versus Clopidogrel in Older Patients with NSTE-ACS Using Oral Anticoagulation: A Sub-Analysis of the POPular Age Trial.,"There are no randomised data on which antiplatelet agent to use in elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC). The randomised POPular Age trial, in patients of 70 years or older with NSTE-ACS, showed a reduction in bleeding without increasing thrombotic events in patients using clopidogrel as compared to ticagrelor. In this sub-analysis of the POPular AGE trial, we compare clopidogrel with ticagrelor in patients with a need for oral anticoagulation. The follow-up duration was one year. The primary bleeding outcome was Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding. The primary thrombotic outcome consisted of cardiovascular death, myocardial infarction and stroke. The primary net clinical benefit outcome was a composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding. A total of 184/1011 (18.2%) patients on OAC were included in this subanalysis; 83 were randomized to clopidogrel and 101 to ticagrelor. The primary bleeding outcome was lower in the clopidogrel group (17/83, 20.9%) compared to the ticagrelor group (33/101, 33.5%;  p  = 0.051), as was the thrombotic outcome (7/83, 8.4% vs. 19/101, 19.2%;  p  = 0.035) and the primary net clinical benefit outcome (23/83, 27.7% vs. 49/101, 48.5%;  p  = 0.003). In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk. This analysis therefore suggests that, in line with the POPular Age trial, clopidogrel is a better option than ticagrelor in NSTE-ACS patients ≥70 years using OAC.",2020,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","['A total of 184/1011 (18.2%) patients on OAC', 'patients with a need for oral anticoagulation', 'Older Patients with NSTE-ACS', 'elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC', 'patients of 70 years or older with NSTE-ACS']","['Oral Anticoagulation', 'clopidogrel with ticagrelor', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['primary bleeding outcome', 'thrombotic risk', 'bleeding without increasing thrombotic events', 'composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding', 'thrombotic outcome', 'cardiovascular death, myocardial infarction and stroke', 'Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043566', 'cui_str': '(1,2-diamino-4-nitrobenzene)dichloroplatinum(II)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.110778,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","[{'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Gimbel', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Tavenier', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'Bor', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'de Vrey', 'Affiliation': 'Department of Cardiology, Meander Medical Centre, 3813TZ Amersfoort, The Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord-west Hospital group, 1815JD Alkmaar, The Netherlands.'}, {'ForeName': 'Melvyn Tjon Joe', 'Initials': 'MTJ', 'LastName': 'Gin', 'Affiliation': 'Department of Cardiology, Rijnstate, 6815AD Arnhem, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Waalewijn', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, 7334DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, 8934AD Leeuwarden, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'den Hartog', 'Affiliation': 'Department of Cardiology, Gelderse Vallei Hospital, 6716RP Ede, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, 2333ZA Leiden, The Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, 7512KZ Enschede, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deneer', 'Affiliation': 'Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics University, Medical Center Utrecht and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103249']
3235,33053626,"Effect of Food Containing Paramylon Derived from  Euglena gracilis  EOD-1 on Fatigue in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial.","Euglena gracilis  EOD-1, a kind of microalgae, is known to contain a high proportion of paramylon, a type of β-1,3-glucan. Paramylon derived from  E. gracilis  EOD-1 is presumed to suppress cellular oxidative injury and expected to reduce fatigue and fatigue sensation. Therefore, we aimed to examine whether food containing paramylon derived from  E. gracilis  EOD-1 (EOD-1PM) ingestion reduced fatigue and fatigue sensation in healthy adults. We conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study in 66 healthy men and women who ingested a placebo or EOD-1PM daily for 4 weeks (daily life fatigue). Furthermore, at the examination days of 0 and 4 weeks, tolerance to fatigue load was evaluated using mental tasks (task-induced fatigue). We evaluated fatigue sensation using the Visual Analogue Scale, the work efficiency of the advanced trail making test and measured serum antioxidant markers. The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group. These results indicate that EOD-1PM ingestion reduced fatigue and fatigue sensation, which may be due to an increase in antioxidant potential and maintenance of selective attention during work.",2020,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"['Healthy Adults', 'daily for 4 weeks (daily life fatigue', 'healthy adults', '66 healthy men and women who ingested a']","['Food Containing Paramylon', 'EOD-1PM', 'placebo or EOD-1PM', 'EOD-1PM ingestion', 'food containing paramylon derived from  E. gracilis  EOD-1 (EOD-1PM) ingestion', 'placebo', 'Placebo']","['tolerance to fatigue load', 'fatigue sensation', 'levels of physical and mental fatigue sensations', 'fatigue and fatigue sensation', 'serum biological antioxidant potential levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0070074', 'cui_str': 'paramylon'}, {'cui': 'C1509133', 'cui_str': 'post meridiem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}]",66.0,0.441904,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"[{'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Naito', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Kashiwagi', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sugino', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'RIKEN Center for Biosystems Dynamics Research, Kobe, Hyogo 650-0047, Japan.'}]",Nutrients,['10.3390/nu12103098']
3236,33053651,Effects of Physical Rehabilitation and Nutritional Intake Management on Improvement in Tongue Strength in Sarcopenic Patients.,"The study aimed to investigate the impact of physical intervention and the amount of nutritional intake on the increase in tongue strength and swallowing function in older adults with sarcopenia. From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed. The intervention employed in the study was the usual physical and occupational therapy for two months. Tongue strength was measured before and after two months of treatment. Data on tongue strength, the amount of energy and protein intake, intervention time, and swallowing function were examined. A total of 95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years). The mean tongue strength after the intervention was significantly increased from 25.4 ± 8.9 kPa to 30.5 ± 7.6 kPa as a result of the treatment ( p  < 0.001). After adjusting the confounding factors in the multivariable models, an energy intake of ≥30 kcal/kg/day and a protein intake of ≥1.2 g/kg/day based on the ideal body weight had a significant impact on the increase in tongue strength after the treatment ( p  = 0.011 and  p  = 0.020, respectively). Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001). Physical intervention and strict nutritional management for older inpatients with sarcopenia could be effective to improve tongue strength and swallowing function.",2020,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001).,"['older adults with sarcopenia', 'Sarcopenic Patients', '95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years', 'older inpatients with sarcopenia', 'From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed']","['Physical Rehabilitation and Nutritional Intake Management', 'Physical intervention and strict nutritional management', 'physical intervention']","['tongue strength, the amount of energy and protein intake, intervention time, and swallowing function', 'mean tongue strength', 'Swallowing function assessed using the Mann Assessment of Swallowing Ability', 'Tongue strength', 'tongue strength', 'tongue strength and swallowing function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}]",95.0,0.0128166,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70];  p  < 0.001).,"[{'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Nagano', 'Affiliation': 'Department of Nursing, Nishinomiya Kyoritsu Neurosurgical Hospital, 11-1 Imazuyamanaka-cho, Nishinomiya, Hyogo 663-8211, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Geriatric Medicine, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi 474-8511, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Koike', 'Affiliation': 'Division of Rehabilitation, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Kurume University, 67 Asahimachi, Kurume 830-0011, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ueshima', 'Affiliation': 'Department of Clinical Nutrition and Food Service, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shimizu', 'Affiliation': 'Department of Nutrition, Hamamatsu City Rehabilitation Hospital, 1-6-1 Wago-kita, Naka-ku, Hamamatsu, Shizuoka 433-8127, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Okinawa Chuzan Hospital Clinical Research Center, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Department of Rehabilitation Medicine, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Yuria', 'Initials': 'Y', 'LastName': 'Ishida', 'Affiliation': 'Department of Nutrition, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}, {'ForeName': 'Naoharu', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Palliative and Supportive Medicine, Graduate School of Medicine, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}]",Nutrients,['10.3390/nu12103104']
3237,33053728,Effect of Psycho-Regulatory Massage Therapy on Pain and Depression in Women with Chronic and/or Somatoform Back Pain: A Randomized Controlled Trial.,"Chronic unspecific back pain (cBP) is often associated with depressive symptoms, negative body perception, and abnormal interoception. Given the general failure of surgery in cBP, treatment guidelines focus on conservative therapies. Neurophysiological evidence indicates that C-tactile fibers associated with the oxytonergic system can be activated by slow superficial stroking of the skin in the back, shoulder, neck, and dorsal limb areas. We hypothesize that, through recruitment of C-tactile fibers, psycho-regulatory massage therapy (PRMT) can reduce pain in patients with cBP. In our study, 66 patients were randomized to PRMT or CMT (classical massage therapy) over a 12-week period and tested by questionnaires regarding pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II = Beck depression inventory), and disability (ODI = Oswestry Disability Index). In all outcome measures, patients receiving PRMT improved significantly more than did those receiving CMT. The mean values of the HSAL sensory subscale decreased by -51.5% in the PRMT group compared to -6.7% in the CMT group. Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively. The results suggest that the superiority of PRMT over CMT may rely on its ability to activate the C-tactile fibers of superficial skin layers, recruiting the oxytonergic system.",2020,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","['Chronic unspecific back pain (cBP', '66 patients', 'patients with cBP', 'Women with Chronic and/or Somatoform Back Pain']","['Psycho-Regulatory Massage Therapy', 'psycho-regulatory massage therapy (PRMT', 'PRMT or CMT (classical massage therapy', 'PRMT']","[' Beck depression inventory), and disability (ODI = Oswestry Disability Index', 'patients receiving PRMT', 'mean values of the HSAL sensory subscale', 'Pain and Depression', 'pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II', 'Depressive symptoms']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",66.0,0.0581292,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","[{'ForeName': 'Sabine B-E', 'Initials': 'SB', 'LastName': 'Baumgart', 'Affiliation': 'Faculty of Medicine, Institute for Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Baumbach-Kraft', 'Affiliation': 'M.Sc. Public Health, 24105 Kiel, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Lorenz', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Life Science, University of Applied Sciences, 21033-Hamburg, Germany.'}]",Brain sciences,['10.3390/brainsci10100721']
3238,33053024,COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial.,"OBJECTIVE


The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19.
METHODS


This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.",2020,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"['Eligible patients', '350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19', 'adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19']","['corticosteroids', 'DEXamethasone (CoDEX', 'dexamethasone', 'standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group']","['ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation', 'cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation', 'number of days alive and free of mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",350.0,0.244425,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"[{'ForeName': 'Bruno Martins', 'Initials': 'BM', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Israel Silva', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flavia Regina', 'Initials': 'FR', 'LastName': 'Bueno', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Vitoria Aparecida Oliveira', 'Initials': 'MVAO', 'LastName': 'Silva', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Franca Pellison', 'Initials': 'FP', 'LastName': 'Baldassare', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Eduardo Leite Vieira', 'Initials': 'ELV', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Ricardo Antonio Bonifácio', 'Initials': 'RAB', 'LastName': 'Moura', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Michele Ouriques', 'Initials': 'MO', 'LastName': 'Honorato', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'André Nathan', 'Initials': 'AN', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Hospital Beneficência Portuguesa - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute (BCRI) - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200063']
3239,33053252,"Impact of the DC/TMD instructional video on the practical skills of undergraduate students-A single-blinded, randomized controlled trial.","INTRODUCTION


Competencies in the clinical examination of patients with temporomandibular disorders (TMD) can be achieved by self-instruction. This study aimed to identify the impact of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) instructional video on the practical examination skills of undergraduate students.
MATERIALS AND METHODS


One week prior to completing an objective structured clinical examination (OSCE) addressing the examination of patients with TMD, undergraduate students in their third year received either the DC/TMD manual (control group) or additionally watched the instructional video once (intervention group). After passing the OSCE, a feedback questionnaire was completed by the students.
RESULT


Fifty undergraduates were recruited to take part in the OSCE prior to their first clinical course. The sum scores achieved in the stations were higher in the intervention group, but missed significance. Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (P = .023). 95.8% of the participating students supported the implementation of the video in dental education.
DISCUSSION


Due to the conception of the study, the video was only presented once to ensure that the control group had no access to the medium at all. However, it might be interesting to investigate whether repeated watching of the video enhances its effect.
CONCLUSIONS


Clinical competencies in the examination of TMD patients can be achieved by self-instruction with the DC/TMD manual and instructional video. Watching the video for educational purposes was highly recommended by undergraduate students.",2020,"Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (p = 0.023).","['patients with temporomandibular disorders (TMD', 'undergraduate students', '50 undergraduates were recruited to take part in the OSCE prior to their first clinical course', 'patients with TMD, undergraduate students in their third year received either the']","['DC/TMD instructional video', 'DC/TMD manual (control group) or additionally watched the instructional video once (intervention group']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}]","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],50.0,0.0346906,"Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (p = 0.023).","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rauch', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Jahn', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anuschka', 'Initials': 'A', 'LastName': 'Roesner', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hahnel', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schierz', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Leipzig, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12618']
3240,33053258,Effect of Action-Based Cognitive Remediation on cognitive impairment in patients with remitted bipolar disorder: A randomized controlled trial.,"OBJECTIVES


Cognitive impairment affects many patients with bipolar disorder (BD), and treatments with replicated pro-cognitive effects are lacking. This study aimed to assess the effect of Action-Based Cognitive Remediation (ABCR) vs control treatment on cognitive impairment in patients with BD.
METHODS


Patients with remitted BD with objective cognitive impairment were randomized to 10 weeks of ABCR vs control treatment, and assessed at baseline, after 2 weeks of treatment, at treatment completion and at 6 months follow-up. The primary outcome was a cognitive composite score. Secondary outcomes were executive function and observer-rated functional capacity. Tertiary measures included additional neuropsychological tests, performance-based functional capacity and quality of life. Data were analysed with linear mixed effects models.
RESULTS


In total, 64 participants were randomized; given three dropouts before the baseline assessments, data were analysed for 61 participants (ABCR: n = 32, control: n = 29). There was no effect on ABCR vs control on the primary cognitive composite score (P-values ≥.60). At treatment completion, there was a large effect of ABCR vs control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], P ≤ .01, d = 0.65), and on subjective cognitive functioning (treatment effect = -5.38, 95% CI [-8.13, -2.67], P ≤ .001, d = 0.80), which disappeared at follow-up. There was no treatment-effect on functioning, and no association between cognitive and functional change.
CONCLUSIONS


There was no effect of ABCR on the cognitive composite score. However, there was an effect on executive function and subjective cognitive functioning suggesting that ABCR may be relevant for patients with executive dysfunction.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03295305.",2020,"At treatment completion, there was a large effect of ABCR vs. control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], p≤0.01, d=0.65), and on subjective cognitive functioning (treatment effect=","['patients with BD', 'patients with executive dysfunction', '64 participants were randomised; given three dropouts before the baseline assessments, data were analysed for 61 participants (ABCR: n=32, control: n=29', 'Patients with remitted BD with objective cognitive impairment', 'patients with bipolar disorder (BD', 'patients with remitted bipolar disorder']","['Action-Based Cognitive Remediation (ABCR) vs. control treatment', 'ABCR', 'Action-Based Cognitive Remediation', 'ABCR vs. control treatment']","['primary cognitive composite score', 'additional neuropsychological tests, performance-based functional capacity and quality of life', 'cognitive impairment', 'executive function and observer-rated functional capacity', 'cognitive composite score', 'secondary executive function measure', 'executive function and subjective cognitive functioning', 'cognitive and functional change', 'subjective cognitive functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",64.0,0.244971,"At treatment completion, there was a large effect of ABCR vs. control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], p≤0.01, d=0.65), and on subjective cognitive functioning (treatment effect=","[{'ForeName': 'Caroline V', 'Initials': 'CV', 'LastName': 'Ott', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kamilla W', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Bipolar disorders,['10.1111/bdi.13021']
3241,33053279,Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States.
METHODS


In an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose.
RESULTS


A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples.
CONCLUSIONS


The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2-3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).",2020,"BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults.","['younger adults', '195 participants underwent randomization', 'Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg', 'younger adults from trials in Germany and the United States', '13 groups of 15 participants, 12 participants received', 'healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either', 'younger and older adults']","['placebo or one of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1', 'placebo', 'vaccine', 'Two RNA-Based Covid-19 Vaccine Candidates']","['Safety and Immunogenicity', 'safety (e.g., local and systemic reactions and adverse events); immunogenicity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",195.0,0.498477,"BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults.","[{'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': ""From the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).""}]",The New England journal of medicine,['10.1056/NEJMoa2027906']
3242,33053283,Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis.,"BACKGROUND


Upadacitinib is an oral selective Janus kinase inhibitor to treat rheumatoid arthritis. The efficacy and safety of upadacitinib as compared with abatacept, a T-cell costimulation modulator, in patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs) are unclear.
METHODS


In this 24-week, phase 3, double-blind, controlled trial, we randomly assigned patients in a 1:1 ratio to receive oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs. The primary end point was the change from baseline in the composite Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP; range, 0 to 9.4, with higher scores indicating more disease activity) at week 12, assessed for noninferiority. Key secondary end points at week 12 were the superiority of upadacitinib over abatacept in the change from baseline in the DAS28-CRP and the percentage of patients having clinical remission according to a DAS28-CRP of less than 2.6.
RESULTS


A total of 303 patients received upadacitinib, and 309 patients received abatacept. From baseline DAS28-CRP values of 5.70 in the upadacitinib group and 5.88 in the abatacept group, the mean change at week 12 was -2.52 and -2.00, respectively (difference, -0.52 points; 95% confidence interval [CI], -0.69 to -0.35; P<0.001 for noninferiority; P<0.001 for superiority). The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority). During the treatment period, one death, one nonfatal stroke, and two venous thromboembolic events occurred in the upadacitinib group, and more patients in the upadacitinib group than in the abatacept group had elevated hepatic aminotransferase levels.
CONCLUSIONS


In patients with rheumatoid arthritis refractory to biologic DMARDs, upadacitinib was superior to abatacept in the change from baseline in the DAS28-CRP and the achievement of remission at week 12 but was associated with more serious adverse events. Longer and larger trials are required in order to determine the effect and safety of upadacitinib in patients with rheumatoid arthritis. (Funded by AbbVie; SELECT-CHOICE Clinicaltrials.gov number, NCT03086343.).",2020,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","['303 patients received upadacitinib, and 309 patients received', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis', 'patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs']","['abatacept', 'oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs', 'Upadacitinib or Abatacept']","['disease activity', 'superiority of upadacitinib over abatacept', 'death, one nonfatal stroke, and two venous thromboembolic events', 'elevated hepatic aminotransferase levels', 'percentage of patients having remission', 'composite Disease Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",303.0,0.246607,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}]",The New England journal of medicine,['10.1056/NEJMoa2008250']
3243,33053849,"Sirolimus Prolongs Survival after Living Donor Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria: A Prospective, Randomised, Open-Label, Multicentre Phase 2 Trial.","Sirolimus (SRL) has been reported to benefit patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC). This study aimed to compare SRL with tacrolimus (TAC) in living-donor LT (LDLT) recipients beyond the Milan criteria. This study was initially designed to enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria. At 1 month after LT, the patients were randomly assigned to either SRL or TAC-based treatment, with both groups receiving mycophenolate mofetil. The primary outcome was three-year recurrence-free survival (RFS) and the secondary outcome was overall survival (OS). A total of 42 patients completed the study. HCC recurrence occurred in 8 of 22 (36.4%) patients in the SRL group and in 5 of 22 (25%) patients in the TAC group. No differences in RFS and OS were found between the two groups in simple comparison. The type of immunosuppressant remained a nonsignificant factor for recurrence in multivariate analysis; however, SRL significantly prolonged OS (TAC hazard ratio: 15 [1.3-172.85],  p  = 0.03) after adjusting for alpha-fetoprotein and positron emission tomography standardised uptake value ratio (tumour/background liver). In conclusion, SRL does not decrease HCC recurrence but prolongs OS after LDLT for HCC beyond the Milan criteria.",2020,No differences in RFS and OS were found between the two groups in simple comparison.,"['living-donor LT (LDLT) recipients beyond the Milan criteria', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC', '42 patients completed the study', 'enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria']","['mycophenolate mofetil', 'SRL or TAC', 'SRL with tacrolimus (TAC', 'Sirolimus (SRL', 'Living Donor Liver Transplantation', 'Sirolimus']","['year recurrence-free survival (RFS', 'RFS and OS', 'HCC recurrence', 'overall survival (OS']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",42.0,0.0965822,No differences in RFS and OS were found between the two groups in simple comparison.,"[{'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jeong-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Suk Kyun', 'Initials': 'SK', 'LastName': 'Hong', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Sung-Sik', 'Initials': 'SS', 'LastName': 'Han', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Sang-Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103264']
3244,33053855,A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects.,"The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO 2 -P 2 O 5 -B 2 O 3  glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.",2020,Osteolysis around 3D printed BGS-7 implants was not observed.,"['A total of eight patients were enrolled in the study', 'patients with obvious zygoma defects who needed and wanted reconstruction']","['BGS-7 3D printed implant', 'O 5 -B 2 O 3  glass-ceramic (BGS-7) implants', 'patient-specific additive-manufactured CaOSiO 2 -P 2', '3D Printed Bioceramic Implants']","['average fusion rate', 'bone fusion between the implant and the bone evaluated by computed tomography (CT', 'implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety', 'mean distance displacement', 'visual analog scale score for satisfaction', 'clinical efficacy and safety']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0608663', 'cui_str': 'P-2'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4721411', 'cui_str': 'Osteolysis'}, {'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",8.0,0.0391568,Osteolysis around 3D printed BGS-7 implants was not observed.,"[{'ForeName': 'Ui-Lyong', 'Initials': 'UL', 'LastName': 'Lee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Chung-Ang University Hospital, Soeul 06973, Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Sung-Nam', 'Initials': 'SN', 'LastName': 'Park', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Byoung-Hun', 'Initials': 'BH', 'LastName': 'Choi', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul 06974, Korea.'}, {'ForeName': 'Won-Cheul', 'Initials': 'WC', 'LastName': 'Choi', 'Affiliation': 'Chung-Ang 3D Craniofacial Research Society, Chun-Ang University, Seoul 06974, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13204515']
3245,33063882,Nalbuphine on postoperative gastrointestinal tract dysfunction after laparoscopic surgery for gynaecological malignancies: A randomized controlled trial.,"The aim of this study was to compare the effects of nalbuphine and sufentanil on the gastrointestinal (GI) tract after laparoscopic surgery for gynaecological malignancies. A total of 100 patients with American Society of Anesthesiologists (ASA) physical status I-II undergoing laparoscopic radical hysterectomy under general anaesthesia were enrolled. The patients were randomized to receive sufentanil (Group S) or nalbuphine (Group N) intraoperatively and postoperatively. The time to first passage of flatus, the time to first defaecation, the time to toleration of diet, the serum gastrin level, and the duration of hospital stay of the groups were compared. The Visual Analogue Scale (VAS) score for postoperative pain, the number of dispensed patient-controlled analgaesics (PCAs), and the prevalence of postoperative nausea, vomiting, and dizziness of the groups were also compared. The time to first passage of flatus (P = .551), time to first defaecation (P = .310), time to toleration of diet (P = .182), serum gastrin level (P = .397), prevalence of postoperative nausea (P = .920) and vomiting (P = .334), number of dispensed PCAs (P = .167), and the duration of hospital stay (P = .482) of the two groups were not significantly different. The VAS scores at 6 hours (P = .008), 12 hours (P = .002), and 24 hours (P = .013) postoperatively were lower in Group N than in Group S. In conclusion, nalbuphine was not associated with improved postoperative GI dysfunction after laparoscopic surgery for gynaecological malignancies, but it was associated with reduced postoperative pain.",2020,"The time to first passage of flatus (p = 0.551), time to first defaecation (p = 0.310), time to toleration of diet (p = 0.182), serum gastrin level (p = 0.397), prevalence of postoperative nausea (p = 0.920) and vomiting (p = 0.334), number of dispensed PCAs (p = 0.167), and the duration of hospital stay (p = 0.482) of the two groups were not significantly different.","['gynecological malignancies', '100 patients with American Society of Anesthesiologists (ASA) physical status I-II undergoing laparoscopic radical hysterectomy under general anaesthesia were enrolled', 'gastrointestinal (GI) tract after laparoscopic surgery for gynaecological malignancies']","['sufentanil', 'nalbuphine', 'nalbuphine and sufentanil', 'laparoscopic surgery', 'Nalbuphine']","['serum gastrin level', 'Visual Analogue Scale (VAS) score for postoperative pain, the number of dispensed patient-controlled analgesics (PCAs), and the prevalence of postoperative nausea, vomiting, and dizziness', 'VAS scores', 'time to first passage of flatus, the time to first defaecation, the time to toleration of diet, the serum gastrin level, and the duration of hospital stay', 'time to first defaecation', 'number of dispensed PCAs', 'duration of hospital stay', 'time to toleration of diet', 'postoperative GI dysfunction', 'time to first passage of flatus', 'prevalence of postoperative nausea', 'postoperative gastrointestinal tract dysfunction', 'vomiting', 'postoperative pain']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",100.0,0.065248,"The time to first passage of flatus (p = 0.551), time to first defaecation (p = 0.310), time to toleration of diet (p = 0.182), serum gastrin level (p = 0.397), prevalence of postoperative nausea (p = 0.920) and vomiting (p = 0.334), number of dispensed PCAs (p = 0.167), and the duration of hospital stay (p = 0.482) of the two groups were not significantly different.","[{'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}]",Clinical and experimental pharmacology & physiology,['10.1111/1440-1681.13421']
3246,33063909,Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis.,"An orally administered, fixed-dose coformulation of sodium phenylbutyrate-taurursodiol (PB-TURSO) significantly slowed functional decline in a randomized, placebo-controlled, phase 2 trial in ALS (CENTAUR). Herein we report results of a long-term survival analysis of participants in CENTAUR. In CENTAUR, adults with ALS were randomized 2:1 to PB-TURSO or placebo. Participants completing the 6-month (24-week) randomized phase were eligible to receive PB-TURSO in the open-label extension. An all-cause mortality analysis (35-month maximum follow-up post-randomization) incorporated all randomized participants. Participants and site investigators were blinded to treatment assignments through the duration of follow-up of this analysis. Vital status was obtained for 135 of 137 participants originally randomized in CENTAUR. Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% confidence interval, 0.34-0.92; P = .023). Initiation of PB-TURSO treatment at baseline resulted in a 6.5-month longer median survival as compared with placebo. Combined with results from CENTAUR, these results suggest that PB-TURSO has both functional and survival benefits in ALS.",2020,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023).
","['adults with ALS', '135 of 137 participants originally randomized in CENTAUR', 'participants in CENTAUR']","['sodium phenylbutyrate-taurursodiol (PB-TURSO', 'placebo', 'PB-TURSO in the open-label extension (OLE']","['Median overall survival', 'median survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0031465', 'cui_str': 'Phenylbutyrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",137.0,0.647067,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023).
","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': 'Swedish Neuroscience Institute, Seattle, Washington.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': 'Departments of Neurology and Medicine, Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Margaret Ayo', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': 'Department of Neurology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': 'Department of Neurology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas, Texas.'}, {'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Heiman-Patterson', 'Affiliation': 'Department of Neurology, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Neurology, The University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': 'Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': 'Department of Neurology, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, San Francisco, California.'}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, San Francisco, California.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': 'Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'Department of Neurology, University of South Florida Morsani College of Medicine, Tampa, Florida.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, Iowa.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California, Irvine School of Medicine, Irvine, California.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': 'Neurology Associates, Lincoln, Nebraska.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': 'Independent Consultant, Nobleboro, Maine.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eydinov', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'St Pierre', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, District of Columbia.'}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': 'Statistics Collaborative, Inc., Washington, District of Columbia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': 'Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Muscle & nerve,['10.1002/mus.27091']
3247,33064415,Exercise for Weight Loss: Further Evaluating Energy Compensation with Exercise.,"PURPOSE


This study assessed how individuals compensate for energy expended during a 12-wk aerobic exercise intervention, elucidating potential mechanisms and the role exercise dose plays in the compensatory response.
PARTICIPANTS AND DESIGN


Three-arm, randomized controlled trial among sedentary adults age 18 to 40 yr, body mass index of 25 to 35. Groups included six exercise sessions per week, two sessions per week, and sedentary control.
METHODS


Rate of exercise energy expenditure was calculated from a graded exercise test averaged across five heart rate zones. Energy compensation was calculated as the difference between expected weight loss (based on exercise energy expenditure) and changes in fat and fat-free mass (DXA). Resting energy expenditure was assessed via indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1) were assessed fasting and postprandial (six timepoints over 2 h).
RESULTS


The 6-d·wk group expended more energy (2753.5 kcal) and exercised longer (320.5 min) per week than the 2-d·wk group (1490.7 kcal, 1888.8 min, P < 0.05), resulting in greater fat loss compared with the 2-d or control groups (P < 0.05). Exercise groups did not differ in the % or total kcal compensated. Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity. Changes in leptin AUC was the only independent predictor for energy compensation, with a greater decrease in leptin AUC predicting less energy compensation. Exercise frequency, energy expended, duration, or intensity did not influence energy compensation.
CONCLUSIONS


Leptin is an important factor in successful weight loss through exercise, with greater postprandial decreases promoting less compensation. Greater amounts of exercise do not influence the compensatory response to an exercise-induced energy deficit.",2020,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","['sedentary adults age 18 to 40 yr, body mass index of 25 to 35']",['aerobic exercise intervention'],"['weight loss', 'greater fat loss', 'area under the curve (AUC', 'fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity', 'Energy compensation', 'Exercise frequency, energy expended, duration, or intensity', 'Weight Loss', 'leptin AUC', 'indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0556162,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': '1Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, KY 2College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': ''}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': ''}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002376']
3248,32981554,"Shared decision making, aggression, and coercion in inpatients with schizophrenia.","BACKGROUND


The present study aimed at answering three research questions: (a) Does shared decision making (SDM) yield similar effects for patients with involuntary admission or incidents of aggression compared to patients with voluntary admission or without incidents of aggression? (b) Does SDM reduce the number of patients with incidents of aggression and the use of coercive measures? (c) Does the use of coercion have a negative impact on patients' perceived involvement in decision making?
METHODS


We used data from the cluster-randomized SDM-PLUS trial in which patients with schizophrenia or schizoaffective disorder in 12 acute psychiatric wards of 4 German psychiatric hospitals either received an SDM-intervention or treatment as usual. In addition, data on aggression and coercive measures were retrospectively obtained from patients' records.
RESULTS


The analysis included n = 305 inpatients. Patient aggression as well as coercive measures mostly took place in the first days of the inpatient stay and were seldom during the study phase of the SDM-PLUS trial.Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression. The intervention showed no effect on patient aggression and coercive measures. Having previously experienced coercive measures did not predict patients' rating of perceived involvement.
CONCLUSION


Further research should focus on SDM-interventions taking place in the very first days of inpatients treatment and potential beneficial long effects of participatory approaches that may not be measurable during the current inpatient stay.",2020,"Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression.","['patients with schizophrenia or schizoaffective disorder in 12 acute psychiatric wards of 4 German psychiatric hospitals either received an', 'patients with involuntary admission or incidents of aggression compared to patients with voluntary admission or without incidents of aggression', 'inpatients with schizophrenia', 'n\xa0=\xa0305 inpatients', 'Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to']",['SDM-intervention or treatment as usual'],"['patient aggression and coercive measures', 'perceived involvement, adherence, and treatment satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C1277270', 'cui_str': 'Involuntary admission'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0376348', 'cui_str': 'Voluntary admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",305.0,0.052904,"Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'John', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Siafis', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brieger', 'Affiliation': 'kbo Isar-Amper-Klinikum München Ost, Haar, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'kbo Isar-Amper-Klinikum München Ost, Haar, Germany.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2020.88']
3249,33059798,Health Promotion Programs and Policies in the Workplace: An Exploratory Study With Alaska Businesses.,"INTRODUCTION


We examined health insurance benefits, workplace policies, and health promotion programs in small to midsize businesses in Alaska whose workforces were at least 20% Alaska Native. Participating businesses were enrolled in a randomized trial to improve health promotion efforts.
METHODS


Twenty-six Alaska businesses completed from January 2009 through October 2010 a 30-item survey on health benefits, policies, and programs in the workplace. We generated frequency statistics to describe overall insurance coverage, and to detail insurance coverage, company policies, and workplace programs in 3 domains: tobacco use, physical activity and nutrition, and disease screening and management.
RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200). Most businesses offered at least partial health insurance for full-time employees and their dependents. Businesses completely banned tobacco in the workplace, and insurance coverage for tobacco cessation was limited. Eighteen had onsite food vendors, yet fewer than 6 businesses offered healthy food options, and even fewer offered them at competitive prices. Cancer screening and treatment were the health benefits most commonly covered by insurance.
CONCLUSION


Although insurance coverage and workplace policies for chronic disease screening and management were widely available, significant opportunities remain for Alaska businesses to collaborate with federal, state, and community organizations on health promotion efforts to reduce the risk of chronic illness among their employees.",2020,"RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200).","['Workplace', 'Twenty-six Alaska businesses completed from January 2009 through October 2010 a 30-item survey on health benefits, policies, and programs in the workplace']",[],[],"[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],[],,0.0267488,"RESULTS


Businesses varied in the number of employees (mean, 250; median, 121; range, 41-1,200).","[{'ForeName': 'Craig N', 'Initials': 'CN', 'LastName': 'Sawchuk', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 200 First St SW, Rochester, MN 55905. Email: sawchuk.craig@mayo.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'University of Alaska, Anchorage, Alaska.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Alaska Native Tribal Health Consortium, Anchorage, Alaska.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Sabin', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Goldberg', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Madesclaire', 'Affiliation': 'Institute for Research and Education, Washington State University, Spokane, Washington.'}, {'ForeName': 'Olivia E', 'Initials': 'OE', 'LastName': 'Bogucki', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Institute for Research and Education, Washington State University, Spokane, Washington.'}]",Preventing chronic disease,['10.5888/pcd17.200111']
3250,33054836,The effect of life coaching on psychological distress among dental students: interventional study.,"BACKGROUND


Depression, stress, and anxiety are common psychological conditions among dental students in many countries around the world. A number of researchers have found life coaching to be effective at reducing psychological distress. The aim of this study was to assess the effect of a life coaching program on dental students' psychological status.
METHODS


A quasi-experiment study with two arms was conducted on 88 female dental students at Umm Al-Qura University (study group = 44; control group = 44). The psychological status was assessed by questionnaire before and after intervention. The questionnaire was composed of the Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions. The study group received a coaching program comprising one lecture for 1 h and five phone coaching sessions over 5 weeks, while the control group received no intervention.
RESULTS


The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale. Also, goal approach was significantly improved. On the other hand, the control group showed a significant reduction on the RS-14 only. The differences in the tested scales between the study group and the control group from pre-intervention (T1) to post-intervention (T2) showed significant differences in depression, stress, self-acceptance, and goal approach measurements per t-test.
CONCLUSION


The study's findings showed that life coaching had the effect of reducing psychological distress, which encouraged the implementation of coaching practice in the daily life of dental students.",2020,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","['88 female dental students at Umm Al-Qura University (study group\u2009=\u200944; control group\u2009=\u200944', 'dental students', ""dental students' psychological status""]","['life coaching program', 'coaching program comprising one lecture for 1\xa0h and five phone coaching sessions', 'control group received no intervention', 'life coaching']","['psychological distress', 'depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale', 'depression, stress, self-acceptance, and goal approach measurements per t-test', 'Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]",88.0,0.0221632,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Al-Zaidi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Jawa', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Hanouf', 'Initials': 'H', 'LastName': 'Al-Harbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Raghad', 'Initials': 'R', 'LastName': 'Alharbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Shahad', 'Initials': 'S', 'LastName': 'Al-Otaibi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC psychology,['10.1186/s40359-020-00475-5']
3251,33054882,Challenges and solutions to nicotine replacement therapy access: observations from SCIMITAR.,"BACKGROUND


Given that smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by the National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services.
AIMS


This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision.
METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT). Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated.
RESULTS


Access to NRT varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines.
CONCLUSIONS


Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.",2020,"METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT).","['patients with severe mental ill health', 'Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR']","['NRT', 'nicotine replacements therapy (NRT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],,0.0597588,"METHOD


Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT).","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}]",BJPsych open,['10.1192/bjo.2020.100']
3252,33065163,Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections?,"BACKGROUND & AIMS


Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism.
METHODS


143 subjects (age > 18; BMI ≥ 27 kg/m 2 ) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISI Clamp  (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2 AT ) was measured in subcutaneous adipose tissue before and after weight loss.
RESULTS


ACE-2 AT  was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2 AT  (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 ∗ 10 -7 ). A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2 AT  (p = 0.011).
CONCLUSIONS


Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT00850629, https://clinicaltrials.gov/ct2/show/NCT00850629, date of registration: February 25, 2009.",2020,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.",['143 subjects (age\u202f>\u202f18; BMI\u202f≥\u202f27\u202fkg/m 2 '],"['lifestyle intervention', 'ACE-2']","['Insulin sensitivity (IS', 'ACE-2  AT  (ΔACE-2 AT ', 'degree of changes in insulin resistance', 'Weight loss', 'ISI Clamp', 'ACE-2 mRNA expression (ACE-2 AT ']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",143.0,0.0156104,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.","[{'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Soll', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Beer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brachs', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany. Electronic address: joachim.spranger@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154401']
3253,33065191,A randomized controlled trial testing the effects of a positive front-of-pack label with or without a physical activity equivalent label on food purchases.,"BACKGROUND


Positive front-of-pack (FOP) labels, including Singapore's Healthier Choice Symbol (HCS), target a subset of healthier products whose consumption is to be encouraged. However, this may inadvertently lead to excess caloric intake, which could be addressed by including an additional label identifying calories per serving. We test this hypothesis by adding a Physical Activity Equivalent (PAE) label, an indicator of calorie content, to all products available in an on-line grocery store.
METHODS


We conducted a randomized controlled trial using a 3 arm within-subject crossover design in adult Singapore residents recruited online. Participants shopped once in each condition in an experimental online grocery store in random order: 1) no FOP label (Control); 2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE). 117 participants were recruited and data from 317 shops were analyzed. We used first-differenced regressions to assess the impact of the conditions on calories per serving (primary) and on other measures of diet quality.
RESULTS


The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%). However, neither the HCS-only (3.45; 95% CI, -12.52: 19.43) nor HCS + PAE (8.14; 95% CI, -5.25: 21.54) condition led to a change in the number of calories per serving purchased or changes in other measures of diet quality.
CONCLUSIONS


Positive labels, like the HCS, are likely to increase purchases of labelled products. However, these changes may not lead to improvements in diet quality or calorie intake. Combining positive labels with additional PAE information does not appear to address this concern.",2020,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","['117 participants were recruited and data from 107 shops were analyzed', 'adult Singapore residents who were recruited online']","['Physical Activity Equivalent (PAE) label', 'Positive Front-of-Pack Label', 'FOP label (Control', '2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE', ""positive FOP label, Singapore's Healthier Choice Symbol (HCSs""]",['diet quality or calorie intake'],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0010996', 'cui_str': 'Information Display'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",117.0,0.203633,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Felicia Jia Ler', 'Initials': 'FJL', 'LastName': 'Ang', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Han Melvin', 'Initials': 'WHM', 'LastName': 'Wong', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Rob M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}]",Appetite,['10.1016/j.appet.2020.104997']
3254,33064207,The effects of a novel herbal toothpaste on salivary lactate dehydrogenase as a measure of cellular integrity.,"OBJECTIVE


Lactate dehydrogenase (LDH) is a critical intracellular enzyme responsible for anaerobic respiration in pyruvate metabolism which becomes detectable in extracellular spaces after cellular breakdown. This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP (1000 ppm F) in a calcium carbonate base formulated with natural ingredients (Ved Shakti, Colgate Palmolive India) and a fluoride toothpaste containing 0.76% SMFP (1000 ppm F) in a calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control) on salivary LDH in conjunction with the assessments of dental plaque and gingivitis representing oral hygiene parameters.
MATERIALS AND METHODS


This double-blind, two-cell study enrolled 70 adults (age range 20-59 years). Subjects completed a washout and provided baseline saliva samples for LDH analysis and clinical assessments of dental plaque and gingivitis using the Turesky Modification of Quigley-Hein and Loe-Silness methods respectively. Subjects were randomly assigned to brush their teeth with either the test or control. Post-treatment sample collection and clinical evaluations were conducted after 3 weeks, 6 weeks, and 12 week sof brushing with all assessments conducted 12 h after hygiene. Statistical analyses were conducted independently for each parameter by t-test for within treatment evaluation and analysis of covariance (ANCOVA) for between treatment comparisons.
RESULTS


At baseline, treatment groups demonstrated no significant differences for LDH or dental plaque and gingival index scores. Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control. The test demonstrated reductions in LDH of 9.5-15.4% over the study period in comparison to the control representing statistically significant effects (p < 0.05). The test also demonstrated reductions in dental plaque that ranged between 6.4 and 16.2% over the study period and gingivitis reductions that ranged between 8.2 and 23.8% representing statistically significant results (p < 0.05).
CONCLUSIONS


Brushing with a novel herbal toothpaste demonstrated significant reductions in salivary LDH representing improvements in cellular integrity with concurrent reductions in dental plaque and gingivitis as compared to the control dentifrice.
CLINICAL RELEVANCE


Salivary LDH measurements offer a non-invasive and objective measurement of mucosal cellular integrity complementing other evaluations and clinical assessments such as plaque and gingival index scores.",2020,"Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control.",['70 adults (age range 20-59 years'],"['novel herbal toothpaste', 'calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control', 'toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP', 'fluoride toothpaste containing 0.76% SMFP']","['gingivitis reductions', 'plaque and gingival index scores', 'dental plaque', 'salivary lactate dehydrogenase', 'LDH', 'salivary LDH, plaque and gingival index scores', 'LDH or dental plaque and gingival index scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009076', 'cui_str': 'Clove'}, {'cui': 'C1658087', 'cui_str': 'Syzygium aromaticum'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0969742', 'cui_str': 'Amla'}, {'cui': 'C1095052', 'cui_str': 'Melia azadirachta'}, {'cui': 'C0522470', 'cui_str': 'Ocimum'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C0772239', 'cui_str': 'ZINC CITRATE'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}]",70.0,0.0776068,"Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control.","[{'ForeName': 'Prem K', 'Initials': 'PK', 'LastName': 'Sreenivasan', 'Affiliation': 'Department of Oral Biology, Rutgers School of Dental Medicine, Newark, NJ, 07103, USA.'}, {'ForeName': 'Veera Venkata Prasad', 'Initials': 'VVP', 'LastName': 'Kakarla', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, 580009, India. kakarlap@hotmail.com.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharda', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, 580009, India.'}, {'ForeName': 'Yogitha', 'Initials': 'Y', 'LastName': 'Setty', 'Affiliation': 'Public Health Dentistry SDM College of Dental Sciences and Hospital SDM College of Dental Sciences & Hospital, Affiliated to SDM University, Dharwad, Karnataka, 580009, India.'}]",Clinical oral investigations,['10.1007/s00784-020-03623-8']
3255,33064404,Effects of Cognitive Training and Exergaming in Pediatric Cancer Survivors-A Randomized Clinical Trial.,"PURPOSE


Although most pediatric cancer patients survive, those who undergo anticancer treatments like chemotherapy and/or radiotherapy are at a high risk for late effects, such as cognitive deficits. To counteract these deficits, feasible and effective interventions are needed. The aim of this study was to compare the effects of working memory training, exergaming, and a wait-list control condition on cognitive functions in pediatric cancer survivors.
METHODS


In a parallel-group randomized trial, 69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53) were randomly assigned to 8-wk working memory training, exergaming, or a wait-list control group. Each training course consisted of three 45-min training sessions per week. The primary outcome comprised the core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions. Assessments were conducted both before and immediately after the interventions, and at 3-month follow-up.
RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group. No other intervention effects of either type of training could be detected.
CONCLUSION


This study presents evidence that working memory training improves visual working memory in pediatric cancer survivors. Results show that near-transfer, but no far-transfer effects can be expected from working memory training. Multiple-component interventions tailored to fit the individual's cognitive profile are needed to best support cognitive development after cancer and its treatment.",2020,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","['Pediatric Cancer Survivors', 'pediatric cancer survivors', 'pediatric cancer patients survive, those who undergo anticancer treatments like', '69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53']","['Cognitive Training and Exergaming', '8-wk working memory training, exergaming, or a wait-list control group', 'working memory training, exergaming, and a wait-list control condition', 'working memory training', 'chemotherapy and/or radiotherapy']","['visual working memory', ""core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions""]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",69.0,0.0718329,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Benzing', 'Affiliation': ""1Institute of Sport Science, University of Bern, Bern, SWITZERLAND 2Division of Pediatric Hematology and Oncology, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 3Division of Neuropaediatrics, Development and Rehabilitation, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 4Institute of Psychology, University of Bern, Bern, SWITZERLAND 5Division of Pediatric Oncology, University Children's Hospital Zurich, Zurich, SWITZERLAND.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'SpitzhÜttl', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Siegwart', 'Affiliation': ''}, {'ForeName': 'JÜrg', 'Initials': 'J', 'LastName': 'Schmid', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grotzer', 'Affiliation': ''}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Heinks', 'Affiliation': ''}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Roebers', 'Affiliation': ''}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Steinlin', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002386']
3256,33055515,Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration.,"SIGNIFICANCE


E-Scoop, a spectacle lens, provides no clinically relevant improvements on quality of life, visual acuity, and contrast sensitivity for patients with AMD. Because patients' burden is high and therapeutic options are scarce, the incentive to develop effective vision rehabilitation interventions remains.
PURPOSE


Patients with AMD experience low quality of life due to vision loss, despite angiogenesis inhibitor interventions that slow down progression for some patients. E-Scoop, which includes low-power prisms, 6% magnification, yellow tint, and antireflection coating, might aid in daily activities by improving distance viewing. Separately, these features have little proven effectiveness. E-Scoop has not been formally tested. This study aimed to determine the impact of E-Scoop on quality of life and the effect on visual acuity and contrast sensitivity.
METHODS


In this randomized controlled, open-label trial, 190 of 226 eligible patients were included. The primary outcome was quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire. Secondary outcomes were visual acuity and contrast sensitivity. The follow-up for quality of life was after 6 weeks for controls and after 3 weeks of use for E-Scoop wearers. The visual measures were repeated after 6 weeks, with optimal refractive correction, with and without E-Scoop.
RESULTS


Randomization resulted in 99 E-Scoop and 86 control group patients for intention-to-treat analysis. No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53). Statistically significant but small effects were found in favor of E-Scoop on binocular visual acuity (mean difference, 0.05 logMAR [2.5 letters, P < .001]) and contrast sensitivity (mean difference, 0.10 logCS [2 letters, P < .001]).
CONCLUSIONS


No effect of E-Scoop on quality of life was found. E-Scoop showed effects that were statistically significant, although not clinically meaningful and within typical variability, on visual measures.",2020,"No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53).","['patients with AMD', '190 of 226 eligible patients were included', 'Macular Degeneration']","['E-Scoop', 'Spectacle Lens']","['quality of life, visual acuity, and contrast sensitivity', '25-item National Eye Institute Visual Function Questionnaire', 'binocular visual acuity', 'contrast sensitivity', 'visual acuity and contrast sensitivity', 'quality of life', 'quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}]","[{'cui': 'C0183177', 'cui_str': 'Scoop'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",226.0,0.230606,"No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53).","[{'ForeName': 'Martijn S', 'Initials': 'MS', 'LastName': 'Visser', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Joanneke', 'Initials': 'J', 'LastName': 'Kampen-Smalbrugge', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Buis', 'Affiliation': 'Revoir Group, the Hague, the Netherlands.'}, {'ForeName': 'Jan Roelof', 'Initials': 'JR', 'LastName': 'Polling', 'Affiliation': 'Department of Ophthalmology, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'J J V', 'Initials': 'JJV', 'LastName': 'Busschbach', 'Affiliation': 'Section of Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001588']
3257,33058522,"Effective lightening of facial melasma during the summer with a dual regimen: A prospective, open-label, evaluator-blinded study.","BACKGROUND


Melasma is a chronic pigmentary condition that can have significant negative effects on quality of life. Vitamin C can be effective in the treatment melasma, but its delivery often proves to be challenging due to instability of the drug and subsequent cutaneous irritation at higher concentrations.
AIM


In this prospective, open-label, evaluator-blinded study, we aimed to assess the efficacy and tolerability of twice-daily application of a novel, highly potent, non-irritating 30% tetrahexyldecyl (THD) ascorbate serum in combination with 100% mineral-based sunscreen in the treatment of melasma during the summer months.
PATIENTS/METHODS


Ten female subjects of ages ranging from 18 to 60 years underwent twice-daily application of 30% THD ascorbate serum in combination with an anti-aging 100% mineral tinted broad-spectrum protection SPF 45 sunscreen moisturizer for 12 weeks during the summer months (July to September). Two blinded evaluators scored baseline and post-treatment photographs using the Griffiths' 10-point scale and global aesthetic improvement scale.
RESULTS


All subjects showed an improvement in hyperpigmentation with an average improvement of 33.7%. Seventy percent of subjects showed an improvement in skin tone evenness (redness), and among those subjects, the average improvement was 33.3%. The median global aesthetic improvement score was 2.0 (very much improved).
CONCLUSION


Our study demonstrated efficacy and safety in treating the pigmentary as well as vascular components of melasma with a novel 30% THD ascorbate serum and a purely mineral-based tinted moisturizing sunscreen.",2020,"Seventy percent of subjects showed an improvement in skin tone evenness (redness) and among those subjects, the average improvement was 33.3%.",['Ten female subjects of ages ranging from 18 to 60 years underwent'],"['twice daily application of 30% THD ascorbate serum in combination with an anti-aging 100% mineral tinted broad-spectrum protection SPF 45 sunscreen moisturizer', 'Vitamin C', 'novel, highly potent, non-irritating 30% Tetrahexadecyl (THD) ascorbate serum in combination with 100% mineral-based sunscreen']","[""Griffiths' 10-point scale and global aesthetic improvement scale"", 'efficacy and safety', 'hyperpigmentation', 'median global aesthetic improvement score', 'quality of life', 'efficacy and tolerability', 'skin tone evenness (redness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0812425', 'cui_str': 'Mitotic index'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",10.0,0.0188126,"Seventy percent of subjects showed an improvement in skin tone evenness (redness) and among those subjects, the average improvement was 33.3%.","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Kelm', 'Affiliation': 'Department of Dermatology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Alisar S', 'Initials': 'AS', 'LastName': 'Zahr', 'Affiliation': 'Revision Skincare®, Irving, TX, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kononov', 'Affiliation': 'Revision Skincare®, Irving, TX, USA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Ibrahim', 'Affiliation': 'Chicago Cosmetic Surgery and Dermatology, Chicago, IL, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13787']
3258,33059233,Transverse abdominis activity and ultrasound biofeedback in college golfers with and without low back pain.,"OBJECTIVES


To compare transverse abdominis (TrA) muscle activity in college golfers with and without a history of low back pain (LBP) and examine the effects of ultrasound biofeedback and a functional golf-setup position on TrA activity.
DESIGN


Crossover study.
SETTING


Laboratory.
PARTICIPANTS


Thirty-two (n = 32) collegiate golfers were stratified into either the LBP group (n = 16, 4.6 ± 4.5 LBP episodes) or non-LBP group (n = 16, 0.1 ± 0.3 LBP episodes) based on LBP episodes in the last 6-months.
MAIN OUTCOME MEASURES


Ultrasound measures of TrA activity were performed during standard contractions and contractions with ultrasound biofeedback. Contraction-type order was randomized between two visits. Testing was performed in two positions, supine and golf-setup positions.
RESULTS


We observed no significant differences in TrA activity between the LBP and non-LBP groups. Overall, TrA activity was greater during biofeedback contractions compared to standard contractions, and TrA activity was lower in the golf-setup position compared to the supine position.
CONCLUSIONS


We observed no differences in TrA activity between college golfers with and without LBP. College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.",2020,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"['college golfers with and without low back pain', 'Thirty-two (n\xa0=\xa032) collegiate golfers', 'college golfers with and without a history of low back pain (LBP']","['ultrasound biofeedback and a functional golf-setup position', 'LBP', 'LBP episodes) or non-LBP']","['Transverse abdominis activity and ultrasound biofeedback', 'standard contractions and contractions with ultrasound biofeedback', 'Overall, TrA activity', 'transverse abdominis (TrA) muscle activity', 'TrA activity']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",32.0,0.02025,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Skibski', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: askibski19@adrian.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Burkholder', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: eburkholder@adrian.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Health Professions, James Madison University, Harrisonburg, VA, USA. Electronic address: goetscjw@jmu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.004']
3259,33059317,How to introduce a rotigotine patch to Parkinson's disease patients taking oral dopamine agonists.,"OBJECTIVE


Ways of introducing a rotigotine patch to Parkinson disease (PD) patients include initial induction for dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT), and add-on (AO) for patients already taking oral DAs. We investigated whether or not the introductions method affects the continuation rate of rotigotine patch.
METHODS


The subjects were 188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital. The rate of successful continuation of rotigotine patch for one year after initiation and the reasons for discontinuation were investigated; for the patients who discontinued due to poor efficacy, the DA dose before and after the start of rotigotine patch treatment was determined.
RESULTS


The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group. The most common reason for discontinuation in all groups was skin reactions. Compared with the de novo group, only the OS group had a significantly higher discontinuation rate due to poor efficacy (3.8 % vs. 21.2 %, P <  0.001). However, in the OS group, the continuation rate in the subjects with an increased total DA dose, after rotigotine was introduced, was significantly higher than that in the subjects with a decreased total DA dose (p = 0.031).
CONCLUSION


The use of a rotigotine patch with an equivalent dose should be considered when switching from oral DAs, and appropriate care should be administered for any skin reactions. The present findings suggested that not the introduction method but the use of an equivalent dose between DA formulations might affect the continuation rate of rotigotine patch.",2020,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","['patients already taking oral DAs', '188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital', ""Parkinson's disease patients taking oral dopamine agonists""]","['dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT', 'rotigotine patch']","['continuation rate of rotigotine patch', 'rate of successful continuation of rotigotine patch', 'continuation rate', 'discontinuation rate', '1-year continuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}]",188.0,0.0281234,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yasutaka', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan. Electronic address: shinsuke@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Mishima', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hirotomo', 'Initials': 'H', 'LastName': 'Shibaguchi', 'Affiliation': 'Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kamimura', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106266']
3260,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE


In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS


Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS


In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
3261,33054579,An 8 miRNA-Based Risk Score System for Predicting the Prognosis of Patients With Papillary Thyroid Cancer.,"BACKGROUND


Dysregulation of microRNAs (miRNAs) in papillary thyroid cancer (PTC) might influence prognosis of PTC. This study is aimed to develop a risk score system for predicting prognosis of PTC.
METHODS


The miRNA and gene expression profiles of PTC were obtained from The Cancer Genome Atlas database. PTC samples were randomly separated into training set (n = 248) and validation set (n = 248). The differentially expressed miRNAs (DE-miRNAs) in the training set were screened using limma package. The independent prognosis-associated DE-miRNAs were identified for building a risk score system. Risk score of PTC samples in the training set was calculated and samples were divided into high risk group and low risk group. Kaplan-Meier curves and receiver operating characteristic (ROC) curve were used to assess the accuracy of the risk score system in the training set, validation set and entire set. Finally, a miRNA-gene regulatory network was visualized by Cytoscape software, followed by enrichment analysis.
RESULTS


Totally, 162 DE-miRNAs between tumor and control groups in the training set were identified. An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed. The area under ROC curve in the training set, validation set and entire set was all above 0.93. A miRNA-gene regulatory network involving the 8 DE-miRNAs were built and functional enrichment analysis suggested the genes in the network were significantly enriched into 13 pathways, including calcium signaling pathway and hedgehog signaling pathway.
CONCLUSION


The risk score system developed this study might be used for predicting the prognosis of PTC. Besides, the 8 miRNAs might affect the prognosis of PTC via hedgehog signaling pathway and calcium signaling pathway.",2020,"An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed.","['papillary thyroid cancer (PTC', 'Patients With Papillary Thyroid Cancer']",[],"['Risk score of PTC samples', 'Kaplan-Meier curves and receiver operating characteristic (ROC) curve', 'area under ROC curve']","[{'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}]",248.0,0.0259455,"An 8 independent prognosis-associated DE-miRNAs, (including miR-1179, miR-133b, miR-3194, miR-3912, miR-548j, miR-6720, miR-6734, and miR-6843) based risk score system was developed.","[{'ForeName': 'Wanwan', 'Initials': 'W', 'LastName': 'Yi', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Shanghai, China.'}, {'ForeName': 'Hengwei', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}]",Technology in cancer research & treatment,['10.1177/1533033820965594']
3262,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
3263,33065275,Vitamin D and survival in COVID-19 patients: A quasi-experimental study.,"Vitamin D may be a central biological determinant of COVID-19 outcomes. The objective of this quasi-experimental study was to determine whether bolus vitamin D3 supplementation taken during or just before COVID-19 was effective in improving survival among frail elderly nursing-home residents with COVID-19. Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study. The ""Intervention group"" was defined as those having received bolus vitamin D3 supplementation during COVID-19 or in the preceding month, and the ""Comparator group"" corresponded to all other participants. The primary and secondary outcomes were COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score in acute phase, respectively. Age, gender, number of drugs daily taken, functional abilities, albuminemia, use of corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin), and hospitalization for COVID-19 were used as potential confounders. The Intervention (n = 57; mean ± SD, 87.7 ± 9.3years; 79%women) and Comparator (n = 9; mean,87.4 ± 7.2years; 67%women) groups were comparable at baseline, as were the COVID-19 severity and the use of dedicated COVID-19 drugs. The mean follow-up time was 36 ± 17days. 82.5% of participants in the Intervention group survived COVID-19, compared to only 44.4% in the Comparator group (P = 0.023). The full-adjusted hazard ratio for mortality according to vitamin D3 supplementation was HR = 0.11[95%CI:0.03;0.48],P = 0.003. Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002). Finally, vitamin D3 supplementation was inversely associated with OSCI score for COVID-19 (β=-3.84[95%CI:-6.07;-1.62], P = 0.001). In conclusion, bolus vitamin D3 supplementation during or just before COVID-19 was associated in frail elderly with less severe COVID-19 and better survival rate.",2020,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"['frail elderly nursing-home residents with COVID-19', 'COVID-19 patients', 'Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study']","['corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin', 'vitamin D3 supplementation', 'Vitamin D', 'bolus vitamin D3 supplementation']","['longer survival time', 'COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score', 'survival rate', 'survival', 'Vitamin D and survival', 'OSCI score']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0878223', 'cui_str': 'Rovamycin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",66.0,0.0876815,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital, Angers, France; UPRES EA 4638, University of Angers, Angers, France; Robarts Research Institute, Department of Medical Biophysics, Schulich School of Medicine and Dentistry, the University of Western Ontario, London, ON, Canada. Electronic address: Cedric.Annweiler@chu-angers.fr.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Hanotte', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Claire Grandin', 'Initials': 'CG', 'LastName': ""de l'Eprevier"", 'Affiliation': 'Geriatric hospital of Saint Laurent de Chamousset, Saint Laurent de Chamousset, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Sabatier', 'Affiliation': 'Université Aix-Marseille, Institut de Neuro-physiopathologie (INP), UMR 7051, Faculté de Pharmacie, 27 Bd Jean Moulin, 13385, Marseille Cedex, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafaie', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Célarier', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France; Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France; Gérontopôle Auvergne-Rhône-Alpes, Saint-Etienne, France.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105771']
3264,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND


Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE


To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS


Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS


Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
3265,31517032,Two-period linear mixed effects models to analyze clinical trials with run-in data when the primary outcome is continuous: Applications to Alzheimer's disease.,"Introduction


Study outcomes can be measured repeatedly based on the clinical trial protocol before randomization during what is known as the ""run-in"" period. However, it has not been established how best to incorporate run-in data into the primary analysis of the trial.
Methods


We proposed two-period (run-in period and randomization period) linear mixed effects models to simultaneously model the run-in data and the postrandomization data.
Results


Compared with the traditional models, the two-period linear mixed effects models can increase the power up to 15% and yield similar power for both unequal randomization and equal randomization.
Discussion


Given that analysis of run-in data using the two-period linear mixed effects models allows more participants (unequal randomization) to be on the active treatment with similar power to that of the equal-randomization trials, it may reduce the dropout by assigning more participants to the active treatment and thus improve the efficiency of AD clinical trials.",2019,"Compared with the traditional models, the two-period linear mixed effects models can increase the power up to 15% and yield similar power for both unequal randomization and equal randomization.
",[],[],[],[],[],[],,0.065849,"Compared with the traditional models, the two-period linear mixed effects models can increase the power up to 15% and yield similar power for both unequal randomization and equal randomization.
","[{'ForeName': 'Guoqiao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Aschenbrenner', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'McDade', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Tammie L S', 'Initials': 'TLS', 'LastName': 'Benzinger', 'Affiliation': 'Department of Radiology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Bateman', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Hassenstab', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Chengjie', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1016/j.trci.2019.07.007']
3266,31419329,Efficacy of THN102 (a combination of modafinil and flecainide) on vigilance and cognition during 40-hour total sleep deprivation in healthy subjects: Glial connexins as a therapeutic target.,,2019,"Most THN102 doses vs. MOD100 also improved the number of correct responses in 2-Back and Go errors in Go/noGo (p<0.05 for all doses), and perseverative responses in WCST (for 100/1 and 100/9).","['20 healthy men', 'healthy subjects', '40-h total sleep deprivation (TSD']","['modafinil and flecainide', 'placebo', 'THN102', 'modafinil', 'placebo (PBO), modafinil 100 mg (MOD100), THN102 100/1, 100/3, 100/9 (modafinil 100mg and flecainide', 'flecainide']","['cardiac conduction', 'vigilance and cognitive function', 'Reaction time in Psychomotor Vigilance Test (PVT), subjective somnolence and vital signs', 'PVT speed vs. MOD100', 'Working memory (2-Back) and executive processes ', 'vigilance and cognition', 'vigilance, working memory and executive functions']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0016229', 'cui_str': 'Flecainide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0987899', 'cui_str': 'modafinil 100 MG'}]","[{'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0518766'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",20.0,,"Most THN102 doses vs. MOD100 also improved the number of correct responses in 2-Back and Go errors in Go/noGo (p<0.05 for all doses), and perseverative responses in WCST (for 100/1 and 100/9).","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Sauvet', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Mégane', 'Initials': 'M', 'LastName': 'Erblang', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Gomez-Merino', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Rabat', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Guillard', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Dubourdieu', 'Affiliation': ""Hôpital d'instruction des armées Percy, Clamart, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefloch', 'Affiliation': ""Hôpital d'instruction des armées Percy, Clamart, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Drogou', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Van Beers', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Bougard', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Cyprien', 'Initials': 'C', 'LastName': 'Bourrrilhon', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Arnal', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Rein', 'Affiliation': 'Theranexus, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Mouthon', 'Affiliation': 'Theranexus, Lyon, France.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Brunner-Ferber', 'Affiliation': 'Brunner Naga, Pfaeffikon, Switzerland.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Leger', 'Affiliation': 'EA 7330 VIFASOM, Hôtel Dieu, Université de Paris, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Centre for Narcolepsy, Sleep Unit, CHU Montpellier, INSERM U1061, France.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Chennaoui', 'Affiliation': 'Unité Fatigue et Vigilance, Institut de recherche biomédicale des armées (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Charvériat', 'Affiliation': 'Theranexus, Lyon, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14098']
3267,31497909,Letter on 'Pharmacy-based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM-CHF randomized controlled trial'.,,2020,,['patients with chronic heart failure'],['Pharmacy-based interdisciplinary intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0833479,,"[{'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Kalmanovich', 'Affiliation': 'Department of Cardiology, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Department of Cardiology, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Castet-Nicolas', 'Affiliation': 'Department of Clinical Pharmacy, Montpellier University Hospital, Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}]",European journal of heart failure,['10.1002/ejhf.1602']
3268,31631216,Evaluating the surrogacy of multiple vaccine-induced immune response biomarkers in HIV vaccine trials.,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism. In this article, we use risk models with multiple vaccine-induced immune response biomarkers to measure the causal association between a vaccine's effects on these biomarkers and that on the clinical endpoint. In this setup, our main objective is to combine and select markers with high surrogacy from a list of many candidate markers, allowing us to get a more parsimonious model which can potentially increase the predictive quality of the true markers. To address the missing ""potential"" biomarker value if a subject receives placebo, we utilize the baseline immunogenicity predictor design augmented with a ""closeout placebo vaccination"" group. We then impute the missing potential marker values and conduct marker selection through a stepwise resampling and imputation method called stability selection. We test our proposed strategy under relevant simulation settings and on (partially simulated) biomarker data from a HIV vaccine trial (RV144).",2019,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism.",['HIV vaccine trials'],['placebo'],[],[{'cui': 'C0086413'}],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0905939,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism.","[{'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Dasgupta', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98122, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98122, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxz039']
3269,30885882,"Benefits From and Barriers to Portable Detection of Gluten, Based on a Randomized Pilot Trial of Patients With Celiac Disease.","Research links diminished quality of life (QOL) to the challenges of a strict gluten-free diet (GFD), the only treatment for celiac disease (CD). 1-4  This pilot study assessed the acceptability and feasibility of a portable gluten sensor device (Nima) to promote GFD adherence and QOL.",2019,1-4  This pilot study assessed the acceptability and feasibility of a portable gluten sensor device (Nima) to promote GFD adherence and QOL.,['Patients With Celiac Disease'],['portable gluten sensor device (Nima'],"['GFD adherence and QOL', 'quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0183210', 'cui_str': 'Sensor device (physical object)'}]",[{'cui': 'C0034380'}],,0.0297591,1-4  This pilot study assessed the acceptability and feasibility of a portable gluten sensor device (Nima) to promote GFD adherence and QOL.,"[{'ForeName': 'Randi L', 'Initials': 'RL', 'LastName': 'Wolf', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, New York.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Norelle R', 'Initials': 'NR', 'LastName': 'Reilly', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Zybert', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, New York.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Medical Center, New York, New York; Department of Epidemiology, Mailman School of Public Health, Columbia University Medical Center, New York, New York. Electronic address: BL114@columbia.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.03.011']
3270,31411779,Mediation analysis of time-to-event endpoints accounting for repeatedly measured mediators subject to time-varying confounding.,"In this article, we will present statistical methods to assess to what extent the effect of a randomised treatment (versus control) on a time-to-event endpoint might be explained by the effect of treatment on a mediator of interest, a variable that is measured longitudinally at planned visits throughout the trial. In particular, we will show how to identify and infer the path-specific effect of treatment on the event time via the repeatedly measured mediator levels. The considered proposal addresses complications due to patients dying before the mediator is assessed, due to the mediator being repeatedly measured, and due to posttreatment confounding of the effect of the mediator by other mediators. We illustrate the method by an application to data from the LEADER cardiovascular outcomes trial.",2019,"In this article, we will present statistical methods to assess to what extent the effect of a randomised treatment (versus control) on a time-to-event endpoint might be explained by the effect of treatment on a mediator of interest, a variable that is measured longitudinally at planned visits throughout the trial.",[],[],[],[],[],[],,0.0611687,"In this article, we will present statistical methods to assess to what extent the effect of a randomised treatment (versus control) on a time-to-event endpoint might be explained by the effect of treatment on a mediator of interest, a variable that is measured longitudinally at planned visits throughout the trial.","[{'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Vansteelandt', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Linder', 'Affiliation': 'Novo Nordisk, Bagsvaerd, Denmark.'}, {'ForeName': 'Sjouke', 'Initials': 'S', 'LastName': 'Vandenberghe', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Steen', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Madsen', 'Affiliation': 'Novo Nordisk, Bagsvaerd, Denmark.'}]",Statistics in medicine,['10.1002/sim.8336']
3271,30734696,Effect Modification by Baseline Mortality in the MORDOR Azithromycin Trial.,"We examined whether baseline mortality risk, as a function of child age and site, modified the azithromycin mortality-reduction effect in the  Macrolide Oraux pour Réduire les Décès avec un Oeil sur la Résistance  (MORDOR) clinical trial. We used the Cox proportional hazards model with an interaction term. Three models were examined representing three sources for the baseline-risk covariate: two using sources external to MORDOR and the third leveraging data within MORDOR. All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality. Etiological and programmatic implications of these findings are discussed.",2020,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.",[],[],['baseline mortality'],[],[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0416482,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.","[{'ForeName': 'Assaf P', 'Initials': 'AP', 'LastName': 'Oron', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Burstein', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington.'}, {'ForeName': 'Laina D', 'Initials': 'LD', 'LastName': 'Mercer', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and the College of Medicine, University of Malawi, Blantyre.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'The London School of Tropical Hygiene and Medicine, London, United Kingdom.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-1004']
3272,31523887,Letter on 'Pharmacy-based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM-CHF randomized controlled trial': reply.,,2020,,['patients with chronic heart failure'],"[""Letter on 'Pharmacy-based interdisciplinary intervention""]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0784457,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Griese-Mammen', 'Affiliation': 'Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III - Cardiology, Angiology and Intensive Care Medicine, University Hospital of Saarland, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Department of Cardiology, University Hospital, Leipzig University, Leipzig, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1613']
3273,31668134,eSupport: Feasibility trial of telehealth support group participation to reduce loneliness in multiple sclerosis.,"BACKGROUND


Loneliness is a risk factor for increased morbidity and mortality. Persons with multiple sclerosis (pwMS) are at increased risk for loneliness. Support groups facilitate meaningful social connections.
OBJECTIVE


To conduct a feasibility trial of eSupport: online support groups.
METHODS


Participants engaged in 1 hour/week eSupport or eJournal (active control). Primary outcome was feasibility (completion and adherence). We evaluated loneliness and depressive symptoms for preliminary efficacy.
RESULTS


Feasibility outcomes were met: completion rate was 96.4%; 88.9% were adherent. Loneliness and depression showed trend-level decreases in both conditions.
CONCLUSION


Feasibility of telehealth support group participation for pwMS was supported. eSupport is accessible, affordable, acceptable, and scalable. Results warrant a randomized controlled trial to support efficacy.",2020,"Loneliness and depression showed trend-level decreases in both conditions.
","['Persons with multiple sclerosis (pwMS', 'Participants engaged in 1\u2009hour/week eSupport or eJournal (active control']",['telehealth support group participation'],"['completion rate', 'feasibility (completion and adherence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]",[],,0.0896176,"Loneliness and depression showed trend-level decreases in both conditions.
","[{'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Leavitt', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Cognitive Neuroscience Division, Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Riley', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'De Jager', 'Affiliation': 'Multiple Sclerosis Center and Center for Translational & Computational Neuroimmunology, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sharonna', 'Initials': 'S', 'LastName': 'Bloom', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519884241']
3274,31957638,Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial.,"STUDY OBJECTIVES


To assess the effects of a yoga versus educational film (EF) program on restless legs syndrome (RLS) symptoms and related outcomes in adults with RLS.
METHODS


Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or EF program (n = 22). In addition to attending classes, all participants completed practice/treatment logs. Yoga group participants were asked to practice at home 30 minutes per day on nonclass days; EF participants were instructed to record any RLS treatments used on their daily logs. Core outcomes assessed pretreatment and posttreatment were RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL).
RESULTS


Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white). Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04). Relative to the EF group, yoga participants demonstrated significantly greater reductions in RLS symptoms and symptom severity (P ≤ .01), and greater improvements in perceived stress and mood (P ≤ .04), as well as sleep quality (P = .09); RLS symptoms decreased to minimal/mild in 77% of yoga group participants, with none scoring in the severe range by week 12, versus 24% and 12%, respectively, in EF participants. In the yoga group, IRLS and RLS severity scores declined with increasing minutes of homework practice (r = .7, P = .009 and r = .6, P = .03, respectively), suggesting a possible dose-response relationship.
CONCLUSIONS


Findings of this exploratory RCT suggest that yoga may be effective in reducing RLS symptoms and symptom severity, decreasing perceived stress, and improving mood and sleep in adults with RLS.
CLINICAL TRIAL REGISTRATION


Registry: Clinicaltrials.gov; Title: Yoga vs. Education for Restless Legs: a Feasibility Study; Identifier: NCT03570515; URL: https://clinicaltrials.gov/ct2/show/NCT03570515.",2020,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","['Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white', 'adults with RLS', 'Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS']","['yoga versus educational film (EF) program', 'EF program', 'educational film intervention']","['RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL', 'RLS symptoms and symptom severity', 'RLS symptoms', 'IRLS and RLS severity scores', 'symptoms of restless legs syndrome and related outcomes', 'perceived stress and mood', 'restless legs syndrome (RLS) symptoms', 'sleep quality', 'RLS symptoms and severity, perceived stress, mood, and QOL-mental health']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",30.0,0.153714,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","[{'ForeName': 'Kim E', 'Initials': 'KE', 'LastName': 'Innes', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Terry Kit', 'Initials': 'TK', 'LastName': 'Selfe', 'Affiliation': 'Health Science Center Libraries, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Zenzi', 'Initials': 'Z', 'LastName': 'Huysmans', 'Affiliation': 'West Virginia University College of Physical Activity and Sport Sciences, Morgantown, West Virginia.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Hausmann', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Maryanna', 'Initials': 'M', 'LastName': 'Klatt', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8134']
3275,32055011,"Comments on ""The effects of a multispecies probiotic on migraine and markers of intestinal permeability-results of a randomized placebo-controlled study"" by de Roos et al.",,2020,,[],"['placebo', 'multispecies probiotic']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],,0.0496701,,"[{'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': ""Department of Clinical Nutrition, Student's Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. zarezadehm@tbzmed.ac.ir.""}]",European journal of clinical nutrition,['10.1038/s41430-020-0586-7']
3276,32183250,"""And Then He Got into the Wrong Group"": A Qualitative Study Exploring the Effects of Randomization in Recruitment to a Randomized Controlled Trial.","BACKGROUND


Randomized controlled trials (RCTs) are regarded as the most internally valid means of estimating the effectiveness of complex public health interventions, but the recruitment of participants can be difficult. The aim of this study was to explore factors that may have affected the recruitment of employees with musculoskeletal disorders (MSDs) to a multicenter worksite health promotion program from the perspective of recruiting case managers.
METHODS


Factors in recruitment to the RCT were explored using three focus group discussions with case managers. Data were processed using MAXQDA and analyzed with a combination of content and sequence analysis.
RESULTS


Findings showed that randomization is a major challenge for recruitment. Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study. Perceptions of the superiority of the intervention group over the control group, perceptions of the (mis)match of participants to one of the groups, as well as the understanding of the necessity of randomization for effectiveness evaluations, further affected recruitment. Perceived expectations of possible participants and their (emotional) reactions to the randomization allocation also complicated recruitment.
CONCLUSION


We were able to gain insight into the challenges of randomization for the recruitment of participants to a multicenter RCT. This study assisted the development of strategies to overcome barriers in the ongoing implementation process of the trial (i.e., the adaption of best practice information sheets and newsletters). There remains a need to develop effective interventions to help those recruiting to trials.",2020,"Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study.",['employees with musculoskeletal disorders (MSDs'],[],[],"[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}]",[],[],,0.106189,"Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study.","[{'ForeName': 'Birthe Andrea', 'Initials': 'BA', 'LastName': 'Lehmann', 'Affiliation': 'Communication Science, University of Amsterdam, 1001 NH Amsterdam, The Netherlands.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Lindert', 'Affiliation': 'Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Ohlmeier', 'Affiliation': 'Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schlomann', 'Affiliation': 'Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Pfaff', 'Affiliation': 'Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.'}, {'ForeName': 'Kyung-Eun', 'Initials': 'KE', 'LastName': 'Choi', 'Affiliation': 'Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17061886']
3277,31989379,The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer.,"PURPOSE


None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC).
METHODS


In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years.
RESULTS


Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time.
CONCLUSIONS


This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials.
TRIAL REGISTRATION


NCT02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015.",2020,"Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population.","['September 14, 2015 after trial initiation on January 31, 2015', 'trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC', 'clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases', 'sentinel lymph node-positive breast cancer']","['breast-conserving therapy', 'breast-conserving surgery and mastectomy', 'axillary lymph node dissection (ALND']",['nodal tumour burden'],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.251093,"Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'de Boniface', 'Affiliation': ""Department of Surgery, Capio St Göran's Hospital, Stockholm, Sweden. jana.de-boniface@ki.se.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ahlgren', 'Affiliation': 'Department of Oncology, University of Örebro, Örebro, Sweden.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgery, Västmanland County Hospital, Västerås, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bergkvist', 'Affiliation': 'Västmanland County Hospital, Center for Clinical Research, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frisell', 'Affiliation': 'Division of Cancer, Department of Breast, Endocrine Tumours and Sarcoma, Karolinska Universitety Hospital, Stockholm, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Olofsson Bagge', 'Affiliation': 'Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Göteborg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Division of Surgery, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Sund', 'Affiliation': 'Surgery Center, Norrland University Hospital, Umeå, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05537-1']
3278,31984781,"To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.","BACKGROUND/AIMS


The  Intent to Attend  is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.
METHODS


Study compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the  Intent to Attend , screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The  Intent to Attend  was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.
RESULTS


Of the 316 caregiver-child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using  Intent to Attend  as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.
CONCLUSION


Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation.",2020,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).",['preterm toddlers'],[],"['caregiver mental health, child sex, or annual income', 'child sex and caregiver mental health']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",316.0,0.224541,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).","[{'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Sullivan', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Wiese', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Clinical trials (London, England)",['10.1177/1740774519893307']
3279,32089078,Effect of Yoga on Antiretroviral Adherence Postincarceration in HIV+ Individuals.,"The negative impacts of stress on antiretroviral therapy (ART) adherence and the many stressors faced by people returning from incarceration support the need for stress reduction interventions for this population. We hypothesized that 37 returning citizens living with HIV and substance use problems randomized to a 12-session weekly yoga intervention would experience improved ART adherence, lower viral loads, and lower heart rate and blood pressure as compared to 36 people randomized to treatment as usual (TAU). We found that ART adherence increased for yoga participants and decreased for TAU participants. There were no significant changes for viral load, heart rate, or blood pressure. The lack of statistically significant effects may be due to a small sample size and enrollment of people largely in HIV treatment. Studies with larger sample sizes and participants exhibiting low ART adherence are warranted to better understand yoga's impact.",2020,"There were no significant changes for viral load, heart rate, or blood pressure.","['37 returning citizens living with HIV and substance use problems', 'HIV+ Individuals']",[],"['ART adherence, lower viral loads, and lower heart rate and blood pressure', 'viral load, heart rate, or blood pressure', 'ART adherence']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0951712,"There were no significant changes for viral load, heart rate, or blood pressure.","[{'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'University of Maryland School of Social Work, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Layde', 'Affiliation': 'Peace Corps, Masasi, Mtwara, Tanzania.'}]",Journal of correctional health care : the official journal of the National Commission on Correctional Health Care,['10.1177/1078345819897924']
3280,31042105,Graduated compression stockings effects on chronic venous disease signs and symptoms during pregnancy.,,2020,"The signs and symptoms in the control vs. intervention group: pain (86.67% vs. 23.33%; p < 0.0001), edema (70.00% vs. 33.33%; p = 0.0045), and leg heaviness (93.33% vs. 13.33%; p < 0.0001).
","['pregnant women', '60 women: intervention group (n\u2009=\u200930), who used', 'chronic venous disease signs and symptoms during pregnancy']","['great saphenous vein and small saphenous vein', 'Compression stockings', 'compression stockings', 'Graduated compression stockings']","['Great saphenous vein diameters', 'pain', 'edema', 'leg heaviness']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0226827', 'cui_str': 'Structure of small saphenous vein'}, {'cui': 'C0038348', 'cui_str': 'Compression Stockings'}]","[{'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",60.0,,"The signs and symptoms in the control vs. intervention group: pain (86.67% vs. 23.33%; p < 0.0001), edema (70.00% vs. 33.33%; p = 0.0045), and leg heaviness (93.33% vs. 13.33%; p < 0.0001).
","[{'ForeName': 'Orlando Adas', 'Initials': 'OA', 'LastName': 'Saliba Júnior', 'Affiliation': 'Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Hamilton Almeida', 'Initials': 'HA', 'LastName': 'Rollo', 'Affiliation': 'Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Saliba', 'Affiliation': 'School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}]",Phlebology,['10.1177/0268355519846740']
3281,32019343,Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.,"BACKGROUND


Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization.
METHODS


We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up.
RESULTS


Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08];  P =0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92];  P =0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18];  P =0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40];  P =0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective.
CONCLUSIONS


In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.",2020,"Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08];  P =0.19).","['patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions', 'Saphenous Vein Graft Percutaneous Coronary Intervention', 'patients enrolled in the', '575 patients included in this substudy']","['Direct stenting without pre-dilation or post-dilation', 'DIVA (Drug-Eluting Stents Versus Bare Metal Stents', 'stent-only percutaneous coronary intervention', 'Stent-Only Versus Adjunctive Balloon Angioplasty Approach']","['number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions', 'composite of definite or probable stent thrombosis', 'target vessel failure', 'vessel myocardial infarction', 'incidence of target vessel failure', '12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization', 'cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up', 'incidence of stent thrombosis', 'incidence of definite stent thrombosis', 'target vessel myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",575.0,0.419308,"Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08];  P =0.19).","[{'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'VA Medical Center, Oklahoma City (F.L.).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Uyeda', 'Affiliation': 'VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edson', 'Affiliation': 'VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': 'VA Boston Healthcare System, MA (D.L., S.K., R.S.V).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Goldman', 'Affiliation': 'University of Arizona Sarver Heart Center, Tucson (S.G.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, MN (D.R.H.).'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Durham VA Medical Center, NC (S.V.R.).'}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Shunk', 'Affiliation': 'San Francisco VA Medical Center, CA (K.S.).'}, {'ForeName': 'Kul', 'Initials': 'K', 'LastName': 'Aggarwal', 'Affiliation': 'Harry S Truman VA Hospital, Columbia, MO (K.A.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Uretsky', 'Affiliation': 'Central Arkansas Veterans Health System, Little Rock (B.U.).'}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Bolad', 'Affiliation': 'Indiana University School of Medicine, Indianapolis (I.B.).'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ziada', 'Affiliation': 'University of Kentucky, Lexington (K.Z.).'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McFalls', 'Affiliation': 'VA Medical Center, Minneapolis, MN (E.M.).'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Irimpen', 'Affiliation': 'Southeast Louisiana Veterans Health Care System, New Orleans (A.I.).'}, {'ForeName': 'Huu Tam', 'Initials': 'HT', 'LastName': 'Truong', 'Affiliation': 'VA Loma Linda Medical Center, CA (H.T.T.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kinlay', 'Affiliation': 'VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'VA Medical center Washington DC (V.P.).'}, {'ForeName': 'Raghava S', 'Initials': 'RS', 'LastName': 'Velagaleti', 'Affiliation': 'VA Boston Healthcare System, MA (D.L., S.K., R.S.V).'}, {'ForeName': 'Bavana V', 'Initials': 'BV', 'LastName': 'Rangan', 'Affiliation': 'Minneapolis Heart Institute Foundation, MN (B.V.R., E.S.B.).'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Atlanta VA Healthcare System, GA (K.M.).'}, {'ForeName': 'Mei-Chiung', 'Initials': 'MC', 'LastName': 'Shih', 'Affiliation': 'VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Dallas VA Medical Center, TX (S.B.).'}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': 'Minneapolis Heart Institute Foundation, MN (B.V.R., E.S.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008494']
3282,32067629,"Impact of Biannual Azithromycin on Anemia in Preschool Children in Kilosa District, Tanzania: A Cluster-Randomized Clinical Trial.","A cluster-randomized clinical trial showed that biannual single-dose azithromycin reduced mortality in preschool children; we sought to determine the effect on anemia. A simple random sample of 30 communities from Kilosa district, Tanzania, were themselves randomized to receive either 6-monthly treatment of children aged 1-59 months with single-dose azithromycin or placebo. From each community, 40 preschool children were randomly selected at baseline, 12 months, and 24 months. At surveys, the children underwent hemoglobin testing; WHO definitions for anemia were applied. After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months. In each of the cross-sectional surveys, anemia prevalence was associated with younger age; the odds of being anemic was highest in those aged < 12 months. There was also a general decrease in the prevalence of anemia during the study. Although azithromycin was not shown to affect anemia, significantly, the study highlights burden of anemia in rural, African communities.",2020,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","['Preschool Children in Kilosa District, Tanzania', '40 preschool children', '30 communities from Kilosa district, Tanzania', 'preschool children']","['azithromycin or placebo', 'Biannual Azithromycin', 'azithromycin']","['prevalence of anemia', 'anemia prevalence']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",40.0,0.144766,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0500']
3283,32072141,"HOVON110/ReBeL Study: Results of the Phase I Part of a Randomized Phase I/II Study of Lenalidomide, Rituximab With or Without Bendamustine in Patients With Relapsed/Refractory Follicular Lymphoma.",Supplemental Digital Content is available in the text.,2020,Supplemental Digital Content is available in the text.,['Patients With Relapsed/Refractory Follicular Lymphoma'],"['Lenalidomide', 'Rituximab With or Without Bendamustine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]",[],,0.0126818,Supplemental Digital Content is available in the text.,"[{'ForeName': 'Wendy B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Chamuleau', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU MC, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Oncology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fijnheer', 'Affiliation': 'Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': 'Department of Internal Medicine, Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany.'}, {'ForeName': 'Hein P J', 'Initials': 'HPJ', 'LastName': 'Visser', 'Affiliation': 'Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Linton', 'Affiliation': 'Manchester Cancer Research Centre, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, University hospital, LMU Munich, Germany.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'Department of Pathology, Amsterdam UMC, VU MC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marie José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Department of Hematology, Amsterdam UMC, University of Amsterdam and Cancer Center Amsterdam and LYMMCARE (Lymphoma and Myeloma Center Amsterdam), Amsterdam, The Netherlands.'}]",HemaSphere,['10.1097/HS9.0000000000000325']
3284,31884870,Effect of a feedback system on the quality of 2-minute chest compression-only cardiopulmonary resuscitation: a randomised crossover simulation study.,"OBJECTIVE


We evaluated the quality of 2-minute continuous chest compressions (CCCs) performed by emergency staff in 30-second intervals to determine the effect of a feedback system on maintaining the quality of CCCs.
METHODS


Two hundred three physicians and nurses were randomised into two groups. Each participant performed 2-minute CCCs both with and without feedback. Group A performed CCCs under the guidance of a feedback device followed by performance without feedback, and Group B performed these tasks in reverse order. The primary outcome was the proportion of optimal compressions; i.e., compressions at both the correct rate (100-120 beats/minute) and correct depth (5-6 cm).
RESULTS


During 2-minute CCCs, the proportion of optimal compressions was poor in personnel without feedback. The proportion of optimal compressions was unchanged and low from 2.4% (interquartile range, 0.0%-32.8%) in the first 30 seconds to 3.3% (0.0%-47.7%) in the last 30 seconds of the 2-minute period. Use of the feedback device significantly improved and maintained the quality of compressions from the first 30 seconds (53.3%; 29.2%-70.4%) to the last 30 seconds (82.8%; 50.8%-96.2%).
CONCLUSION


Use of the feedback device was helpful for maintaining the quality of CCCs.",2020,,[],"['2-minute chest compression-only cardiopulmonary resuscitation', 'feedback system']",[],[],"[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0145469,,"[{'ForeName': 'Chunshuang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shaoyun', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Ying', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuzhi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Anyu', 'Initials': 'A', 'LastName': 'Qian', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Guangju', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}]",The Journal of international medical research,['10.1177/0300060519894440']
3285,31955410,"""In-House"" Data on the Outside-A Mobile Health Approach.","Mobile health (mHealth) technologies have the potential to capture dense patient data on the background of real-life behavior. Merck & Co., Inc. (Kenilworth, NJ), in collaboration with Koneksa Health, conducted a phase I clinical trial to validate cardiovascular mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. This two-part study enrolled 18 healthy male subjects. Part I, a 5-day study, compared mHealth measures of heart rate (HR) and blood pressure (BP) to those from traditional methods. Hypotheses of similarity, in the clinic and at home, were tested individually for HR, systolic BP, and diastolic BP, at a 2-sided 0.05 alpha level, with a prespecified criterion for similarity being the percentage differences between the 2 measurements within 15%. Part II, a 7-day, 3-period randomized balanced crossover study, evaluated the mHealth technology's ability to detect effects of bisoprolol and salbutamol. Hypotheses that the changes from baseline in HR were greater in the bisoprolol (reduction in HR) and salbutamol (increase in HR) groups compared with no treatment were tested, at a 1-sided 0.05 alpha level. Linear mixed-effects models, Pearson's correlation coefficients, summary statistics, and exploratory plots were applied to analyze the data. The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.",2020,"The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.",['18 healthy male subjects'],['bisoprolol and salbutamol'],"['heart rate (HR) and blood pressure (BP', 'HR and BP', 'HR, systolic blood pressure, and diastolic blood pressure']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",18.0,0.0263384,"The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.","[{'ForeName': 'Qinlei', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Crumley', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Walters', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Cluckers', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Heirman', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Bhatia', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cantor', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Benko', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Elena S', 'Initials': 'ES', 'LastName': 'Izmailova', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Drug Research Unit Ghent, Ghent, Belgium.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1790']
3286,32037127,Duration of untreated psychosis and response to treatment: an analysis of response in the OPTiMiSE cohort.,"Some, but not all, studies have found longer duration of untreated psychosis (DUP) to be associated with poor response to treatment and more severe negative symptoms in schizophrenia. The aim of the current analysis was to investigate these parameters in a large cohort of patients in their first psychotic episode. The OPTiMiSE cohort included 446 patients with DUP up to two years, who were administered amisulpride for 4 weeks (Phase I). Patients who did not meet Andreasen remission criteria were randomized to double-blind continuation of amisulpride or olanzapine for 6 additional weeks in a blinded study (Phase II). Analyses showed that shorter DUP was associated with lower baseline CGI scores (p<0.001, r = 0.184), PANSS total (p = 0.025, r = 0.106) and PANSS negative subscale scores (p = 0.023, r = 0.107). Remitters had a significantly shorter mean DUP compared to non-remitters both in Phase I (24.5 weeks ±24.3 vs. 35 weeks ± 32.2, p = 0.01, t=-2.521) and in Phase II (24.3 weeks ± 26.4 vs. 38.3 weeks ± 31.3, p = 0.031, t=-2.194). Logistic regression analyses showed a significant effect of DUP on treatment response both in phase I (p = 0.008) and phase II (p = 0.041). Linear regression analyses found that DUP significantly affects PANSS Total change at the end of phase I (p = 0.028) but not at the end of phase II (p = 0.236). Based on these findings, it is possible to conclude that shorter DUP is associated with better response to treatment, particularly during the first weeks after treatment initiation. These findings highlight the need for early identification of the first psychotic episode.",2020,Remitters had a significantly shorter mean DUP compared to non-remitters both in Phase,"['Patients who did not meet Andreasen remission criteria', '446 patients with DUP up to two years, who were administered', 'large cohort of patients in their first psychotic episode']","['amisulpride or olanzapine', 'amisulpride']","['baseline CGI scores', 'mean DUP', 'PANSS negative subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0338614'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",446.0,0.0316464,Remitters had a significantly shorter mean DUP compared to non-remitters both in Phase,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Levi', 'Affiliation': 'Psychiatry Department, Sheba Medical Center, Tel-Hashomer, 52621 Ramat Gan, Israel.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Bar Haim', 'Affiliation': 'Psychiatry Department, Sheba Medical Center, Tel-Hashomer, 52621 Ramat Gan, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Burshtein', 'Affiliation': 'Psychiatry Department, Sheba Medical Center, Tel-Hashomer, 52621 Ramat Gan, Israel.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter-Van Rossum', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Psychiatry Department, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Psychiatry Department, Sheba Medical Center, Tel-Hashomer, 52621 Ramat Gan, Israel; Nicosia School of Medicine, Cyprus.'}, {'ForeName': 'Geva', 'Initials': 'G', 'LastName': 'Shenkman', 'Affiliation': 'Psychology Department, Interdisciplinary Center Hertzelya, Hertzelya, Israel.'}, {'ForeName': 'René S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine, Mount Sinai, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weiser', 'Affiliation': 'Psychiatry Department, Sheba Medical Center, Tel-Hashomer, 52621 Ramat Gan, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: mweiser@netvision.net.il.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.01.007']
3287,32120445,Less Blood Loss by Earlier Oxytocin Infusion in Cesarean Sections? A Randomized Controlled Trial.,"PURPOSE


The aim of our study was to evaluate the positive effect of starting an IV oxytocin infusion early before uterine incision on intraoperative blood loss.
METHODS


A total of 101 women between 18-40 years who underwent a primary elective cesarean section (CS) were included in this randomized controlled trial. The patients were divided into two groups. In Group I (n=51), oxytocin infusion was administered immediately after incision of the visceral peritoneum during CS. In Group II (n=50), infusion was administered immediately after clamping the umbilical cord. The primary outcome was the mean volume of blood loss during CS. The secondary outcomes included the mean reduction in hemoglobin and hematocrit levels, need for additional uterotonics and hemostatic uterine sutures, blood transfusion, post-operative pain score, and additional surgical procedures.
RESULTS


There were statistical significant differences either in the change of the hemoglobin concentration (1.27±0.75 vs.1.74±0.81; p<0.01) or in the change of hematocrit concentration (3.89±2.24 vs. 5.41±2.93; p<0.01). Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
CONCLUSIONS


Our findings suggest that the starting IV oxytocin infusion early before uterine incision reduces intraoperative blood loss. This could be effective to replace starting IV oxytocin infusion late after umbilical cord clamping or delivery of the placenta.
EINLEITUNG


Das Ziel unserer Studie war es. die positive Wirkung der beginnenden IV Oxytocin-Infusion früh vor der Uterusinzision auf den intraoperativen Blutverlust zu bewerten.
MATERIAL UND METHODIK


In diese randomisierte kontrollierte Studie wurden insgesamt 101 Frauen zwischen 18 und 40 Jahren eingeschlossen, die sich einem primären elektiven Kaiserschnitt unterzogen hatten. Die Patienten wurden in 2 Gruppen eingeteilt. Gruppe I (n=51); Die Oxytocin-Infusion wurde unmittelbar nach der Inzision des viszeralen Peritoneums während der CS verabreicht. Gruppe II (n=50); Die Infusion wurde unmittelbar nach dem Klemmen der Nabelschnur verabreicht. Das primäre Ergebnis war das mittlere Blutverlustvolumen während der CS. Zu den sekundären Ergebnissen gehörte die mittlere Verringerung der Hämoglobin- und Hämatokritwerte, Bedarf an zusätzlichen Uterotonika und hämostatischen Uterusnähten, Bluttransfusion, postoperativer Schmerzscore und zusätzliche chirurgische Eingriffe.
ERGEBNISSE


Es gab statistisch signifikante Unterschiede zwischen der Änderung der Hämoglobinkonzentration 1,27±0,75 vs.1,74±0,81; p<0,01) oder der Änderung der Hämatokritkonzentration(3,89±2,24 vs. 5,41±2,93; p<0,01). Der intraoperative Blutverlust war in Gruppe I im Vergleich zu Gruppe II signifikant geringer (475,86±150,11 vs. 605,1±203,2; p<0,01).
DISKUSSION


Unsere Ergebnisse legen nahe, dass die beginnende intravenöse Oxytocin-Infusion früh vor der Uterusinzision den intraoperativen Blutverlust verringert. Dies könnte wirksam sein, um eine beginnende intravenöse Oxytocin-Infusion zu einem späten Zeitpunkt nach dem Klemmen der Nabelschnur oder der Abgabe der Plazenta zu ersetzen.",2020,"Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
","['Gruppe I (n=51', '101 women between 18-40 years who underwent a primary elective cesarean section (CS', '101 Frauen']","['oxytocin infusion', 'Die Infusion wurde unmittelbar nach dem Klemmen der Nabelschnur verabreicht', 'Oxytocin', 'Gruppe II', 'oxytocin', 'Oxytocin-Infusion zu einem späten', 'Oxytocin-Infusion wurde unmittelbar nach der Inzision']","['hematocrit concentration', 'intraoperative blood loss', 'Intraoperative blood loss', 'mean volume of blood loss', 'hemoglobin concentration', 'mean reduction in hemoglobin and hematocrit levels, need for additional uterotonics and hemostatic uterine sutures, blood transfusion, post-operative pain score, and additional surgical procedures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",101.0,0.147247,"Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
","[{'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Takmaz', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Ozcan', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Sevket', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ayse Filiz Gokmen', 'Initials': 'AFG', 'LastName': 'Karasu', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Sevde Havva', 'Initials': 'SH', 'LastName': 'Islek', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Belfin Nur Arici', 'Initials': 'BNA', 'LastName': 'Halici', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1108-2017']
3288,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
3289,32118696,Chronic Exposure to Low-Dose Carbon Monoxide Alters Hemoglobin Mass and V˙O2max.,"By blocking the oxygen binding sites on the hemoglobin molecule, chronic low-dose carbon monoxide (CO) administration may produce similar effects to those of exposure to altitude.
PURPOSE


This study aimed to determine the effect of chronic low-dose CO application on hemoglobin mass (Hbmass) and V˙O2max.
METHODS


For 3 wk, 11 healthy and moderately trained male subjects inhaled a CO bolus five times per day to increase their HbCO concentration by ~5%. Another 11 subjects received a placebo. Hbmass, serum erythropoietin concentration, ferritin, and basic hematological parameters were determined before and weekly during and until 3 wk after the CO inhalation period. V˙O2max tests on a cycle ergometer were performed before and after the CO administration period.
RESULTS


In the CO group, Hbmass increased from 919 ± 69 to 962 ± 78 g in week 3 (P < 0.001) and was maintained for the following 3 wk. Reticulocytes (%) and immature reticulocyte fraction significantly increased after 1 wk. Serum erythropoietin concentration tended to increase after 1 wk (P = 0.07) and was suppressed in the postperiod (P < 0.01). Ferritin decreased during the inhalation period (from 106 ± 37 to 72 ± 37 ng·mL, P < 0.001). V˙O2max tended to increase from 4230 ± 280 to 4350 ± 350 mL·min (P < 0.1) immediately after the inhalation period and showed a significant relationship to the change in Hbmass (y = 4.1x - 73.4, r = 0.70, P < 0.001).
CONCLUSIONS


Chronic continuous exposure to low-dose CO enhances erythropoietic processes resulting in a 4.8% increase in Hbmass. The individual changes in Hbmass were correlated to the corresponding changes in V˙O2max. Examination of ethical and safety concerns is warranted before the implementation of low-dose CO inhalation in the clinical/athletic setting as a tool for modifying Hbmass.",2020,[EPO] tended to increase after one week (p=0.07) and was suppressed in the post period (p<0.01).,[],"['placebo', 'EPO', 'chronic low dose CO-application']","['hemoglobin mass (Hbmass) and VO2max', 'Reticulocytes (%) and IRF', 'HbCO concentration', 'VO2max', 'Ferritin', 'Hbmass, serum erythropoietin concentration [EPO], ferritin, and basic hematological parameters']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0035286', 'cui_str': 'Reticulocytes'}, {'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",11.0,0.0165678,[EPO] tended to increase after one week (p=0.07) and was suppressed in the post period (p<0.01).,"[{'ForeName': 'Walter F J', 'Initials': 'WFJ', 'LastName': 'Schmidt', 'Affiliation': '1Department of Sports Medicine/Sports Physiology, University of Bayreuth, GERMANY 2Institute of Doping Analysis und Sports Biochemistry, University of Dresden, GERMANY 3Department of Integrative Physiology, University of Colorado, Boulder, CO.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hoffmeister', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Haupt', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schwenke', 'Affiliation': ''}, {'ForeName': 'Nadine B', 'Initials': 'NB', 'LastName': 'Wachsmuth', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Byrnes', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002330']
3290,31853633,Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting.,"INTRODUCTION


The aim of the study was to compare the effectiveness of cognitive behavioural therapy interventions for insomnia (CBT-I) to that of a sleep hygiene intervention in a randomized controlled design among shift workers. We also studied whether the features of shift work disorder (SWD) affected the results.
METHODS


A total of 83 shift workers with insomnia disorder were partially randomized into a group-based CBT-I, self-help CBT-I, or sleep hygiene control intervention. The outcomes were assessed before and after the interventions and at 6-month follow-up using questionnaires, a sleep diary, and actigraphy.
RESULTS


Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time improved after the interventions, but we found no significant differences between the interventions. Mood symptoms improved only among the group-based CBT-I intervention participants. Non-SWD participants had more mental diseases and symptoms, used more sleep-promoting medication, and had pronounced insomnia severity and more dysfunctional beliefs than those with SWD. After the interventions, non-SWD participants showed more prominent improvements than those with SWD.
CONCLUSIONS


Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention. Alleviation of mood symptoms seemed to be the main added value of the group-based CBT-I intervention compared to the control intervention. The clinical condition of the non-SWD participants was more severe and these participants benefitted more from the interventions than the SWD participants did.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02523079.",2020,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"['83 shift workers with insomnia disorder', 'insomnia among shift workers', 'shift workers']","['cognitive behavioural therapy interventions', 'CBT-I, self-help CBT-I, or sleep hygiene control intervention', 'Cognitive behavioural therapy interventions', 'sleep hygiene intervention']","['insomnia severity and more dysfunctional beliefs', 'Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time', 'Mood symptoms', 'sleep diary, and actigraphy']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",83.0,0.0429972,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"[{'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Järnefelt', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland. heli.jarnefelt@ttl.fi.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Härmä', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sallinen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Virkkala', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Kari-Pekka', 'Initials': 'KP', 'LastName': 'Martimo', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Hublin', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}]",International archives of occupational and environmental health,['10.1007/s00420-019-01504-6']
3291,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND


The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN


A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING


A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION


Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES


Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS


Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION


Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
3292,32123978,Patient-Reported Outcomes and Long-Term Results of a Randomized Controlled Trial Comparing Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair.,"BACKGROUND


Surgical techniques for inguinal hernia repair have evolved rapidly from open methods to conventional laparoscopic totally extra-peritoneal (CTEP) and recently single-port TEP (STEP). As there is currently no randomized controlled trial (RCT) reporting long-term patient-reported outcomes between CTEP and STEP, we reviewed patients who were randomized to CTEP or STEP 5 years after surgery.
METHODS


Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011. The modified Body Image Questionnaire was used to measure long-term patient-reported outcomes.
RESULTS


Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the CTEP group responded to phone interviews. Median follow-up time, demographic data and clinical outcomes were comparable between both groups. The Body Image Score (5-20: 5-least dissatisfied, 20-most dissatisfied; BIS score ± SD, STEP vs. CTEP, 5.33 ± 0.90 vs. 7.17 ± 1.87, p < 0.001) and Cosmetic Score (2-20: 2-least satisfied, 20-most satisfied; CS score ± SD, STEP vs. CTEP, 19.05 ± 1.31 vs. 15.87 ± 1.57, p < 0.001) were superior in the STEP group. Similarly, self-reported scar perception (1-cannot be seen, 2-can barely be seen, 3-visible; scar perception score ± SD, STEP vs. CTEP, 1.29 ± 0.51 vs. 2.55 ± 0.64, p < 0.001) and overall experience score (1-least satisfied, 10-most satisfied; overall satisfaction score ± SD, STEP vs. CTEP, 9.57 ± 0.67 vs. 8.22 ± 0.94, p < 0.001) were superior in the STEP group.
CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group. STEP should be strongly considered in patients who are concerned about long-term cosmetic outcomes and should be offered if surgical expertise is available. Trial registration NCT02302937.",2020,"CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","['Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011', 'Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the']","['Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair', 'CTEP', 'conventional laparoscopic totally extra-peritoneal (CTEP']","['Cosmetic Score', 'superior cosmetic and satisfaction scores', 'overall experience score', 'scar perception', 'Body Image Score', 'Median follow-up time, demographic data and clinical outcomes']","[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.160414,"CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","[{'ForeName': 'Daryl Kai Ann', 'Initials': 'DKA', 'LastName': 'Chia', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lomanto', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Wijerathne', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore. sujithwijerathne@gmail.com.'}]",World journal of surgery,['10.1007/s00268-020-05443-z']
3293,31476481,Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Randomized Placebo-Controlled Trial.,"STUDY OBJECTIVE


To evaluate the effect of perioperative duloxetine on pain management in patients recovering from laparoscopic hysterectomy.
DESIGN


A randomized placebo-controlled trial.
SETTING


A university hospital.
PATIENTS


Of 100 patients enrolled, 80 were randomized 1:1 to receive perioperative duloxetine (n = 40) or placebo (n = 40).
INTERVENTIONS


Patients undergoing laparoscopic hysterectomy for benign conditions from November 2017 through March 2018 received 2 doses of 60 mg duloxetine or placebo 2 hours before and 24 hours after surgery.
MEASUREMENTS AND MAIN RESULTS


The Quality of Recovery (QoR)-40 questionnaire was completed by participants after discharge. Study and control groups were compared in terms of questionnaire scores, opioid analgesic use, and hospital length of stay. The baseline characteristics of the groups were comparable; median total QoR-40 scores were 111 of 200 and 112 of 200 for duloxetine and the placebo group, respectively; the difference did not reach statistical significance (p = .91). Although the physical independence subcomponent of the recovery questionnaire was improved in favor of duloxetine, none of the subcomponents reached statistical difference between groups. The groups did not differ in terms of postoperative narcotic analgesic use and hospital length of stay (p >.05).
CONCLUSION


Perioperative duloxetine did not reduce pain, need for narcotic analgesia, or hospital length of stay following laparoscopic hysterectomy.",2020,"The groups did not differ in terms of postoperative narcotic analgesic use and hospital length of stay (p > .05).
","['Of 100 patients enrolled, 80', 'A university hospital', 'patients recovering from laparoscopic hysterectomy']","['laparoscopic hysterectomy', 'perioperative duloxetine', 'duloxetine', 'placebo', 'Laparoscopic Hysterectomy', 'duloxetine or placebo', 'Perioperative Duloxetine', 'Placebo']","['pain, need for narcotic analgesia, or reduce hospital length of stay', 'median total QoR-40 scores', 'Quality of Recovery (QoR)-40 questionnaire', 'pain management', 'Pain Management', 'postoperative narcotic analgesic use and hospital length of stay', 'questionnaire scores, opioid analgesic use, and hospital length of stay']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027409', 'cui_str': 'Narcotic Analgesics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002772', 'cui_str': 'Analgesics, Opioid'}]",80.0,0.494381,"The groups did not differ in terms of postoperative narcotic analgesic use and hospital length of stay (p > .05).
","[{'ForeName': 'Ozguc', 'Initials': 'O', 'LastName': 'Takmaz', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Bastu', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor). Electronic address: ercanbastu@gmail.com.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ozbasli', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Gundogan', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Karabuk', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Muharrem', 'Initials': 'M', 'LastName': 'Kocyigit', 'Affiliation': 'Department of Anesthesiology, Acibadem Mehmet Ali Aydinlar University, Maslak Hospital, Istanbul, Turkey (Dr. Kocyigit).'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Dede', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Naki', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Kose', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Gungor', 'Affiliation': 'Department of Obstetrics and Gynecology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey (Drs. Takmaz, Bastu, Ozbasli, Gundogan, Karabuk, Dede, Naki, Kose, and Gungor).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.04.028']
3294,32103903,Pharmacokinetics and Tolerability of Single and Multiple Intravenous Doses of Cefotetan Disodium in Healthy Chinese Volunteers.,"Background


Cefotetan is highly stable to penicillinase and cephalosporin produced by gram-negative bacteria, and it has strong antimicrobial activity against most gram-negative bacteria, some anaerobic bacteria and streptococcus. The objective of this study was to evaluate the pharmacokinetic profile and tolerability of single and multiple intravenous doses of cefotetan disodium in healthy Chinese volunteers.
Methods


In this single-center, open-label, dose-escalating study, subjects were randomized to receive a single dose of cefotetan disodium 0.5, 1.0, or 2.0 g administered as a 1 h intravenous infusion. After completion of the single-dose phase, subjects continued into the multiple-dose phase, in which they received 1.0 g cefotetan disodium BID for 7 consecutive days. Plasma samples were assayed by a validated high-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated and analyzed statistically. Tolerability was assessed based on physical examinations, vital signs, laboratory tests, and subject interviews.
Results


After intravenous administration of single doses of 0.5, 1.0, and 2.0 g cefotetan disodium, the pharmacokinetics of cefotetan were as follows: C max  was 69.49±12.10 µg·mL -1 , 132.03±22.56 µg·mL -1  and 237.75±42.12 µg·mL -1 , respectively; AUC last  was 278.29±51.13 µg·mL -1 ·h, 543.25±92.44 µg·mL -1 ·h and 1003.8±172.39 µg·mL -1 ·h, respectively; AUC ∞  was 284.42±50.76 µg·mL -1 ·h, 551.38±95.83 µg·mL -1 ·h and 1020.18±181.19 µg·mL -1 ·h, respectively; t 1/2  was 4.21±0.83 h, 4.39±0.53 h and 4.27±0.74 h, respectively; CL was 1.81±0.33 L·h -1 , 1.86±0.32 L·h -1  and 2.02±0.38 L·h -1 , respectively; V d  was 10.80±1.89L, 11.78±2.20L and 12.25±1.99L, respectively. In the multiple-dose study, the pharmacokinetics of cefotetan were as follows: C max,ss  was 147.58±22.71 µg·mL -1 ; C min,ss  was 12.92±3.70 µg·mL -1 ; C avg  was 45.10±7.78 µg·mL -1 ; AUC τ,ss  was 541.15±93.36 µg·mL -1 ·h; AUC ∞  was 612.06±114.23 µg·mL -1 ·h; t 1/2  was 4.30±0.63 h; CL was 1.90±0.35L·h -1 ; V d  was 8.91±1.57L;  DF  was 300.92±33.28%; Accumulation Index was 1.17±0.05. No serious adverse events were reported. Adverse events were generally mild.
Conclusion


Cefotetan disodium showed favorable tolerability in this study. The C max  and AUCs of cefotetan disodium demonstrated dose-dependent pharmacokinetic characteristics after single dose over a dose range (0.5-2.0 g) in healthy subjects, whereas the t 1/2  was independent of dose. Except for V d , there was no difference in other pharmacokinetic parameters between multiple and single administration.",2020,"The C max  and AUCs of cefotetan disodium demonstrated dose-dependent pharmacokinetic characteristics after single dose over a dose range (0.5-2.0 g) in healthy subjects, whereas the t 1/2  was independent of dose.","['healthy Chinese volunteers', 'Healthy Chinese Volunteers']","['Cefotetan disodium', 'cefotetan disodium BID', 'Cefotetan Disodium', 'cefotetan disodium']","['serious adverse events', 'physical examinations, vital signs, laboratory tests, and subject interviews', 'favorable tolerability', 'Accumulation Index', 'pharmacokinetic parameters', 'Pharmacokinetics and Tolerability', 'Pharmacokinetic parameters', 'Tolerability', 'pharmacokinetic profile and tolerability', 'C max', 'Adverse events']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0700471', 'cui_str': 'Cefotetan Disodium'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0414522,"The C max  and AUCs of cefotetan disodium demonstrated dose-dependent pharmacokinetic characteristics after single dose over a dose range (0.5-2.0 g) in healthy subjects, whereas the t 1/2  was independent of dose.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Guolan', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Yunliang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xingjiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Shentu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S234619']
3295,32089798,Why Not a Podcast? Assessing Narrative Audio and Written Curricula in Obstetrical Neurology.,"Background


Medical podcasts have the potential to educate residents and fellows in specialized or uncommon disciplines, but the acceptability and benefits of educational podcasts are unclear.
Objective


We compared knowledge acquisition and engagement of audio-only (podcast) versus written curricular formats and assessed podcast feasibility and uptake for teaching obstetrical neurology to residents and fellows.
Methods


Key concepts in obstetrical neurology were developed into parallel case-based modules: written reviews and podcasts interwove patient and expert voices with narration. In 2017, we tested this curriculum among 60 volunteer residents and fellows in obstetrics and gynecology, neurology, emergency medicine, internal medicine, and family medicine training programs at a single institution. Participants took content-based pretests, were randomized, and then completed written (n = 32) or podcast (n = 28) modules, and finally, completed posttests and feedback questionnaires.
Results


Among all participants, there was an increase in immediate posttest scores compared with pretest scores (46 of 60, 77% ± 17% pretest versus 56 of 60, 93% ± 10% posttest,  P  < .05), with participants in the podcast and written groups performing equally well. However, listeners rated the podcasts somewhat higher than written materials in the areas of maintaining interest, enjoyability, entertaining, and desire for wider use.
Conclusions


Written and podcast curricula improved immediate knowledge similarly, but the narrative-style podcasts were perceived as more enjoyable by residents and fellows from several specialties, suggesting narrative podcasting can be an engaging and feasible educational alternative for trainees to acquire information.",2020,"Among all participants, there was an increase in immediate posttest scores compared with pretest scores (46 of 60, 77% ± 17% pretest versus 56 of 60, 93% ± 10% posttest,  P  < .05), with participants in the podcast and written groups performing equally well.","['60 volunteer residents and fellows in obstetrics and gynecology, neurology, emergency medicine, internal medicine, and family medicine training programs at a single institution', 'Obstetrical Neurology', 'teaching obstetrical neurology to residents and fellows']",['audio-only (podcast) versus written curricular formats'],['immediate posttest scores'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0205484', 'cui_str': 'Obstetrical (qualifier value)'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0306296,"Among all participants, there was an increase in immediate posttest scores compared with pretest scores (46 of 60, 77% ± 17% pretest versus 56 of 60, 93% ± 10% posttest,  P  < .05), with participants in the podcast and written groups performing equally well.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Roth', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Ricci', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Niharika', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': ''}]",Journal of graduate medical education,['10.4300/JGME-D-19-00505.1']
3296,31173939,"Minilaparoscopic Total Hysterectomy in Current Practice Feasibility and Benefits: A Unicentric, Randomized Controlled Trial.","STUDY OBJECTIVE


To investigate whether mini-instrumentation may be used for hysterectomy (HT) by all surgeons (assistants and seniors) without increasing the operative time or altering surgeon working conditions.
DESIGN


A unicenter, randomized controlled, single blind, parallel, noninferiority trial comparing 2 surgical techniques.
SETTING


A tertiary referral center.
PATIENTS


Thirty-two patients undergoing HT for a benign gynecologic disease were enrolled in this study in our center between April 2, 2015, and June 1, 2018. Sixteen patients were randomized in group A and 16 patients in group B.
INTERVENTIONS


HT with bilateral annexectomy or ovarian conservation using 3-mm instruments (group A) or conventional 5-mm instruments (group B).
MEASUREMENTS AND MAIN RESULTS


Concerning the primary outcome, the operative time for the HT 3-mm group was 128 minutes (range, 122-150 minutes) versus 111 minutes (range, 92-143 minutes) for the HT 5-mm group (i.e., δ = 17 [90% confidence interval, -6 to 39]), with rejection of the noninferiority threshold at 35 minutes. Thirty-one percent of HTs initially performed using 3-mm instruments were completed with conventional instruments. HTs performed with mini-instruments required more concentration (p = .02) with surgeons reporting higher levels of frustration (p = .009) and sense of failure (p = .006). Patients tend to experience greater satisfaction regarding scars with a significant difference noted during the postoperative visit both for scar pain (1 vs 4 patients with moderate pain [30-50 mm on the Patient Scar Assessment Scale) in the HT 3-mm group and the HT 5-mm group, respectively) and scar firmness (p = .021; 3 vs 7 patients with moderate firmness [30-50 mm on the Patient Scar Assessment Scale] in the HT 3-mm group and the HT 5-mm group, respectively).
CONCLUSION


Total minilaparoscopic HT appears inferior to standard laparoscopy in terms of operative time and surgeon working conditions; only the short-term cosmetic appearance was in favor of the 3-mm approach.",2020,Hysterectomy carried out with mini instruments required more concentration (p=0.02) with surgeons reporting higher levels of frustration (p=0.009) and sense of failure (p=0.006).,"['16 patients', 'hysterectomy by all surgeons (assistants and seniors', '32 patients undergoing a hysterectomy for a benign gynecological disease were enrolled in this study in our center between April 2nd 2015 and June 1st 2018']","['surgical techniques', 'Total mini-laparoscopic hysterectomy', 'Mini-laparoscopic total hysterectomy', 'mini-instrumentation', 'Hysterectomy (HT) with bilateral annexectomy or ovarian conservation using 3-mm instruments (group A) or conventional 5-mm instruments']","['postoperative visit both for scar pain', 'operative time', 'scar firmness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0017411', 'cui_str': 'Gynecologic Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0404090', 'cui_str': 'Laparoscopic total hysterectomy (procedure)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}, {'cui': 'C0877113', 'cui_str': 'Painful scar'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]",16.0,0.104929,Hysterectomy carried out with mini instruments required more concentration (p=0.02) with surgeons reporting higher levels of frustration (p=0.009) and sense of failure (p=0.006).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Béguinot', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel); Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France, and Department of Surgery, Jean Perrin Comprehensive Center, Clermont-Ferrand, France (Dr. Béguinot).'}, {'ForeName': 'Revaz', 'Initials': 'R', 'LastName': 'Botchorishvili', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Comptour', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Curinier', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Campagne-Loiseau', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Chauvet', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ""Biostatistics Division (Direction de la Recherche Clinique et de l'Innovation) (Dr. Pereira).""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Pouly', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Rabischong', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Canis', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bourdel', 'Affiliation': 'Department of Gynecologic Surgery (Drs. Béguinot, Botchorishvili, Comptour, Curinier, Campagne-Loiseau, Chauvet, Pouly, Rabischong, Canis, and Bourdel). Electronic address: nicolas.bourdel@gmail.com.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.05.016']
3297,31390464,Integrated specialized atrial fibrillation clinics reduce all-cause mortality: post hoc analysis of a randomized clinical trial.,"AIMS


An integrated chronic care programme in terms of a specialized outpatient clinic for patients with atrial fibrillation (AF), has demonstrated improved clinical outcomes. The aim of this study is to assess all-cause mortality in patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme.
METHODS AND RESULTS


Post hoc analysis of a Prospective Randomized Open Blinded Endpoint Clinical trial to assess all-cause mortality in AF patients. The study included 712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital. In the specialized outpatient clinic (AF-Clinic), comprehensive, multidisciplinary, and patient-centred AF care was provided, i.e. nurse-driven, physician supervised AF treatment guided by software based on the latest guidelines. The control group received usual care by a cardiologist in the regular outpatient setting.After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014]. This included cardiovascular mortality in 4 AF-Clinic patients (1.1%) and 14 patients (3.9%) in usual care (HR 0.28; 95% CI 0.09-0.85; P = 0.025). Further, 9 patients (2.5%) died in the AF-Clinic arm due to a non-cardiovascular reason and 15 patients (4.2%) in the usual care arm (HR 0.59; 95% CI 0.26-1.34; P = 0.206).
CONCLUSION


An integrated specialized AF-Clinic reduces all-cause mortality compared with usual care. These findings provide compelling evidence that an integrated approach should be widely implemented in AF management.",2019,"After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014].","['patients with atrial fibrillation (AF', 'AF patients', '712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital', 'patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme']",['usual care by a cardiologist in the regular outpatient setting'],"['cause mortality', 'cardiovascular mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",712.0,0.0512359,"After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014].","[{'ForeName': 'Jeroen M L', 'Initials': 'JML', 'LastName': 'Hendriks', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hubertus J M', 'Initials': 'HJM', 'LastName': 'Vrijhoef', 'Affiliation': 'Department Patient and Care, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Wijtvliet', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Epidemiology, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz209']
3298,32102059,Does Mental Fatigue Negatively Affect Outcomes of Functional Performance Tests?,"PURPOSE


Mental fatigue impairs psychomotor skill performance by affecting visuomotor reaction time, accuracy, and decision-making. Recently, neurocognitive functional performance tests (FPT) that integrate these outcomes have been developed. The aim of this study was to assess the effect of mental fatigue on traditional and neurocognitive FPT in healthy adults.
METHODS


Fourteen volunteers (four women; mean ± SD age, 22 ± 1 yr; height, 176.9 ± 8.4 cm; weight, 69.7 ± 10.4 kg) participated in a randomized counterbalanced crossover design. A 100% incongruent Stroop color word test of 90 min was used to induce mental fatigue and the control task encompassed watching a 90-min documentary. Traditional FPT comprised a single-leg hop for distance, countermovement jump, and Y-balance test, whereas the neurocognitive FPT encompassed the reactive balance test (RBT). All FPTs were evaluated pre-post the 90-min task. Mental fatigue was assessed using the Stroop task, visual analog scale for mental fatigue, and the Eriksen-Flanker task.
RESULTS


Mental fatigue was successfully induced, as shown by a significant increase in visual analog scale for mental fatigue (P < 0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task. No interaction effect of mental fatigue was found for the Y-balance test, single-leg hop, and countermovement jump. For the RBT accuracy, a significant interaction effect of mental fatigue and time was observed (P = 0.024), with participants performing significantly worse when mentally fatigued. No interaction effect or main effect of condition and time was observed when considering the effect of mental fatigue on visuomotor reaction time in the RBT.
CONCLUSIONS


Mental fatigue negatively affects a neurocognitive FPT, indicated by a decreased accuracy in response to visual stimuli in the RBT. Traditional FPT remained unaffected by mental fatigue.",2020,"RESULTS


Mental fatigue was successfully induced, as shown by a significant increase in M-VAS (p<0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task.","['Fourteen volunteers (four women; mean ± SD; age = 22 ± 1 years; height = 176.9 ± 8.4 cm; weight = 69.7 ± 10.4 kg', 'healthy adults']",[],"['reactive balance test (RBT', 'Mental fatigue', 'mental fatigue', 'Stroop task, M-VAS scale and the Eriksen-Flanker task', 'visuomotor reaction time, accuracy and decision-making', 'distance (SLH), countermovement jump (CMJ) and Y-balance test (YBT', 'visuomotor reaction time', 'M-VAS', 'performance on the Stroop and Eriksen-Flanker task', 'mental fatigue and time']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0222045'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",14.0,0.0468719,"RESULTS


Mental fatigue was successfully induced, as shown by a significant increase in M-VAS (p<0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task.","[{'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Verschueren', 'Affiliation': ""1Faculty of Physical Education and Physiotherapy, Human Physiology and Sports Physiotherapy Research Group, Vrije Universiteit Brussel, Brussels, BELGIUM 2Amsterdam Collaboration on Health and Safety in Sports, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Movement Sciences, Amsterdam, the NETHERLANDS 3Strategic Research Program 'Exercise and the Brain in Health & Disease: the added value of Human-Centered Robotics,' Vrije Universiteit Brussel, Brussels, BELGIUM.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tassignon', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Proost', 'Affiliation': ''}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Teugels', 'Affiliation': ''}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'VAN Cutsem', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Roelands', 'Affiliation': ''}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': ''}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Meeusen', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002323']
3299,32112166,A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial.,"BACKGROUND


Effective analgesia is essential for patient recovery after liver resection. This study aimed to evaluate the effects of the addition of preoperative intrathecal morphine to multimodal intravenous analgesia in patients undergoing liver resection.
METHODS


In this single-blind randomized controlled trial, patients undergoing liver resection were randomly assigned to the patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine groups. All patients received acetaminophen and dexketoprofen. The primary outcome was pain severity at rest over three postoperative days, assessed using the numerical rating scale (NRS).
RESULTS


The study included 36 patients (18 in each group). The mean maximum daily NRS scores over the first three postoperative days in the ITM-IV and IV groups were 1.3, 1.1, and 0.3 and 1.6, 1.1, and 0.7, respectively (p = 0.580). No differences were observed in pain severity while coughing, with corresponding scores of 2.8, 2.1, and 1.1, respectively, in the ITM-IV group and 2.3, 2.2, and 1.5, respectively, in the IV group (p = 0.963). Proportions of patients reporting clinically significant pain at rest and while coughing were 11.1% and 44.4%, respectively, in the ITM-IV group, and 16.7% and 44.4%, respectively, in the IV group (both p > 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
CONCLUSIONS


Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection.
TRIAL REGISTRATION NUMBER


Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x']
3300,32112353,Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation.,"Allogeneic hematopoietic cell transplantation (alloHCT) is a life-saving technology that can cure otherwise incurable diseases, but imposes significant physiologic stress upon recipients. This stress leads to short-term toxicity and mid- to long-term physical function impairment in some recipients. Exercise interventions have demonstrated preliminary efficacy in preserving physical function in HCT recipients, but the role of these interventions prior to HCT (prehabilitative) is less known. We tested a 5- to 12-week, prehabilitative higher intensity home-based aerobic exercise intervention in a randomized study of alloHCT candidates. Of 113 patients screened, 34 were randomized to control or intervention groups, 16 underwent pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention 6-min walk distance (6MWD) testing. No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention. We conclude that the design of our prehabilitative intervention was not feasible in this pilot randomized study, and make recommendations regarding the design of future exercise intervention studies in alloHCT.",2020,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","['113 patients screened, 34 were randomized to control or intervention groups, 16 underwent']","['home-based exercise prescription before allogeneic hematopoietic cell transplantation', 'prehabilitative higher intensity home-based aerobic exercise intervention', 'pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention', 'Allogeneic hematopoietic cell transplantation (alloHCT', 'Exercise interventions']","['6-min walk distance (6MWD', 'VO 2peak  or 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",34.0,0.0488959,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wawood@med.unc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Battaglini', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05369-1']
3301,32106713,Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial.,"BACKGROUND


Mobile health interventions, especially smartphone applications (apps), have been proposed as promising interventions for supporting adherence to healthy behaviour in patients post cardiac rehabilitation (CR). The overall aim of the study was to examine the effect of individualized follow-up with an app for one year on peak oxygen uptake (VO 2peak ) in patients completing CR.
DESIGN


The study was designed as a single-blinded multicentre randomized controlled trial.
METHODS


The intervention group (IG) received individualized follow-up enabled with an app for one year, while the control group (CG) received usual care. The primary outcome was difference in VO 2peak . Secondary outcomes included exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement.
RESULTS


In total, 113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases) were randomly allocated to the IG or CG. Intention to treat analyses showed a statistically significant difference in VO 2peak  between the groups at follow-up of 2.2 ml/kg/min, 95% confidence interval 0.9-3.5 ( p  < 0.001). Statistically significant differences were also observed in exercise performance, exercise habits and in self-perceived goal achievement.
CONCLUSIONS


Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR. There were no statistically significant differences between the groups at follow-up in the other outcome measures evaluated.",2020,"Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR.","['post cardiac rehabilitation', 'patients post cardiac rehabilitation (CR', '113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases', 'patients completing CR']","['individualized follow-up enabled with an app for one year, while the control group (CG) received usual care', 'smartphone application', 'IG or CG']","['VO 2peak', 'VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement', 'exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement', 'peak oxygen uptake (VO 2peak ', 'exercise capacity', 'VO 2peak ', 'exercise performance, exercise habits and in self-perceived goal achievement']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",113.0,0.206644,"Individualized follow-up for one year with an app significantly improved VO 2peak , exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR.","[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Lunde', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Grimsmo', 'Affiliation': 'Norwegian Heart and Lung Patient Organization, LHL-Hospital Gardermoen, Norway.'}, {'ForeName': 'Even', 'Initials': 'E', 'LastName': 'Jarstad', 'Affiliation': 'Norwegian Sport Medicine Clinic (NIMI), Department of Cardiology and Exercise Physiology, Norway.'}, {'ForeName': 'Birgitta Blakstad', 'Initials': 'BB', 'LastName': 'Nilsson', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Norway.'}]",European journal of preventive cardiology,['10.1177/2047487320905717']
3302,32101034,An Evolutionary Approach to Binge Drinking Impression Formation: A Cross-Cultural Comparison Between France and Peru.,"Evolutionary medicine proposes studying alcohol use and abuse through the lens of modern evolutionary theory. This study ( https://osf.io/p48 uw/) follows this approach and uses an evolutionary framework to predict how young adults (18-35 years old) form impression of a binge drinker. We predicted that displaying sexual dysfunctions (short-term risk) in a binge drinking video would negatively influence attitudes and expectations of a target when compared to cognitive (short-term risk) or long-term deficits. In the following studies, we use a Zahavian framework to understand and influence impression formation of a male binge drinker among women (intersexual selection) and men (intrasexual competition) participants in a subsequent task. Via a randomized experimental online study in France ( N  = 177,  M  = 23.39 [4.91], 43.50% men) and a preregistered conceptual replication study in Peru ( N  = 176,  M  = 25.61 [4.76], 53.41% men), women exposed to a binge drinking video-describing sexual impotence after a binge drinking episode-tended to downgrade attractiveness evaluation of the binge drinker. However, male participants were not impacted by the different types of signals displayed in the videos. These results show that evolutionary theory could help us understand impression formation in binge drinking context and call for gender-specific health messages.",2020,"In the following studies, we use a Zahavian framework to understand and influence impression formation of a male binge drinker among women (intersexual selection) and men (intrasexual competition) participants in a subsequent task.","['male binge drinker among women (intersexual selection) and men (intrasexual competition) participants in a subsequent task', 'Binge Drinking Impression Formation', 'France ( N  = 177,  M  = 23.39 [4.91], 43.50% men) and a preregistered conceptual replication study in Peru ( N  = 176', 'M  = 25.61 [4.76], 53.41% men', 'young adults (18-35 years old) form impression of a binge drinker']",['binge drinking video-describing sexual impotence'],[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0556346', 'cui_str': 'Binge Drinking'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0556346', 'cui_str': 'Binge Drinking'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]",[],,0.0202208,"In the following studies, we use a Zahavian framework to understand and influence impression formation of a male binge drinker among women (intersexual selection) and men (intrasexual competition) participants in a subsequent task.","[{'ForeName': 'Jordane', 'Initials': 'J', 'LastName': 'Boudesseul', 'Affiliation': 'Facultad de Psicología, Instituto de Investigación Científica (IDIC), Universidad de Lima, Perú.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Vieira', 'Affiliation': 'Laboratoire de Psychologie des Cognitions, University of Strasbourg, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bègue', 'Affiliation': ""Laboratoire Inter-universitaire de Psychologie, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.""}]",Evolutionary psychology : an international journal of evolutionary approaches to psychology and behavior,['10.1177/1474704919897602']
3303,32012409,"Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial.","OBJECTIVE


To compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS).
PATIENTS AND METHODS


This was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q max  ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q max  , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-to-treat analysis was used for outcome measures.
RESULTS


Of the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55 in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q max  were -1.69 (95% confidence interval [CI] -1.4 to -2.0), -0.70 (95% CI -0.60 to -0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group.
CONCLUSION


The combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q max  compared to monotherapy with tamsulosin, without an increase in AEs.",2020,"The improvements in IPSS, IPSS QoL, IIEF and Qmax were -1.69(95% CI -1.4 to -2.0), -0.70","['male lower urinary tract symptoms', 'Men >45 years with moderate LUTS, peak flow rate (Qmax) of 5-15ml/s were included', 'male LUTS']","['Placebo', 'tamsulosin', 'tamsulosin and tadalafil', 'Tamsulosin and placebo', 'tadalafil with tamsulosin']","['IPSS QoL (quality of life), International Index for Erectile Function (IIEF-5) scores, Qmax and post-void residual urine (PVRU', 'efficacy and safety', 'serious adverse events', 'IPSS, IPSS QoL, IIEF and Qmax', 'dropout rate due to adverse events', 'International Prostate Symptom Score (IPSS', 'PVRU', 'adverse events', 'LUTS, QoL, erectile function and Qmax', 'Myalgia']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",140.0,0.55386,"The improvements in IPSS, IPSS QoL, IIEF and Qmax were -1.69(95% CI -1.4 to -2.0), -0.70","[{'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Nagasubramanian', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Nirmal Thampi', 'Initials': 'NT', 'LastName': 'John', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Belavendra', 'Initials': 'B', 'LastName': 'Antonisamy', 'Affiliation': 'Department of, Biostatistics, Christian Medical College, Vellore, India.'}, {'ForeName': 'Rajiv Paul', 'Initials': 'RP', 'LastName': 'Mukha', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Chandra Singh', 'Initials': 'CS', 'LastName': 'Jeyachandra Berry', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Devasia', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Nitin Sudhakar', 'Initials': 'NS', 'LastName': 'Kekre', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}]",BJU international,['10.1111/bju.15027']
3304,32091032,Sustained effects of intralymphatic pollen-specific immunotherapy on Japanese cedar pollinosis.,"BACKGROUND


Intralymphatic immunotherapy (ILIT) for allergic patients requires only a few intralymphatic injections of the allergen. However, the effectiveness and safety for Japanese cedar pollinosis are unclear. The objectives of this study were to clarify whether and how long ILIT is effective for pollinosis, and its safety.
METHODS


In an open pilot investigation followed by a double-blind, placebo-controlled study, patients with Japanese cedar pollinosis received 3 intralymphatic inguinal injections of the pollen extracts before the first pollen season. The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
RESULTS


(1) Although mild adverse events were induced at the injected site, severe adverse events were not noted. (2) During the latter part of the first season, ILIT-treated patients (n=12) tended to show improved SMS compared to placebo-treated (n=6) without statistical significance. When assessed by nasal provocation testing and VAS scoring after the first season, the effectiveness of ILIT was significant. (3) The effects of ILIT continued until the second or third season. (4) Neither allergen-specific antibodies nor Treg/Breg cells changed in the peripheral blood.
CONCLUSIONS


ILIT was safe and effective for Japanese cedar pollinosis. The clinical effects remained for 1-2 years.",2020,"The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
","['allergic patients', 'Japanese cedar pollinosis', 'patients with Japanese cedar pollinosis']","['placebo', 'ILIT', 'intralymphatic inguinal injections of the pollen extracts', 'Intralymphatic immunotherapy (ILIT', 'intralymphatic pollen-specific immunotherapy']","['mild adverse events', 'nasal provocation testing and VAS scoring', 'effectiveness and safety', 'severe adverse events', 'symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0032385', 'cui_str': 'Pollen Grains'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0370664,"The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Terada', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Omura', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kikuoka', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Inaka', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Inui', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Laboratory of Immunopharmacology, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nabe', 'Affiliation': 'Laboratory of Immunopharmacology, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kawata', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}]",Rhinology,['10.4193/Rhin19.301']
3305,31375087,"Study protocol: multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial).","BACKGROUND


Eighty percent of children with idiopathic nephrotic syndrome respond well to steroid therapy, but up to 50% of patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS. Recent studies suggested that rituximab could also be a first-line treatment for early-stage uncomplicated FRNS/SDNS, although further studies are required to confirm its efficacy and safety.
METHODS/DESIGN


We are conducting a multicenter, double-blind, randomized placebo controlled trial to investigate the efficacy and safety of rituximab for the treatment of childhood-onset early-stage uncomplicated FRNS/SDNS. Patients will be allocated to receive two 375 mg/m 2  doses (maximum dose: 500 mg) of either rituximab or placebo. Investigators are permitted to request the disclosure of a subject's allocation code if he or she exhibits treatment failure. Additionally, if placebo-treated subjects display early relapse (a sign of treatment failure), they have the option to receive rituximab in an unblinded phase. The primary endpoint is relapse-free survival during the observation period.
DISCUSSION


The results will provide important data on the use of rituximab for patients with uncomplicated FRNS/SDNS. In the future, rituximab treatment will enable most patients with uncomplicated FRNS/SDNS to discontinue or reduce steroid therapy without relapse, and it is possible that rituximab could represent an immunosuppressive therapy for these diseases.
TRIAL REGISTRATION


This trial was prospectively registered to the JMACCT Clinical Trials Registry on September 6, 2018 (Trial ID: JMA-IIA00380 ).",2019,Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS.,"['patients with complicated FRNS/SDNS', 'patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS', 'Eighty percent of children with idiopathic nephrotic syndrome', 'childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial', 'patients with uncomplicated FRNS/SDNS', 'childhood-onset early-stage uncomplicated FRNS/SDNS']","['placebo', 'rituximab', 'steroid therapy', 'rituximab or placebo']","['relapse-free survival', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome (disorder)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome (disorder)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3496337', 'cui_str': 'Nephrotic Syndrome, Type 2'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.457912,Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS.,"[{'ForeName': 'China', 'Initials': 'C', 'LastName': 'Nagano', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Sako', 'Affiliation': 'Division for Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kamei', 'Affiliation': 'Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishikura', 'Affiliation': 'Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kandai', 'Initials': 'K', 'LastName': 'Nozu', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan. iijima@med.kobe-u.ac.jp.'}]",BMC nephrology,['10.1186/s12882-019-1470-3']
3306,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3307,32023574,High Predictive Value of Adenosine Provocation in Predicting Atrial Fibrillation Recurrence After Pulmonary Vein Isolation With Visually Guided Laser Balloon Compared With Radiofrequency Ablation.,"BACKGROUND


We recently demonstrated that the acute reconnection rate detected with adenosine provocation test (APT) was significantly lower after pulmonary vein isolation (PVI) with visually guided laser balloon ablation (VGLB) than with RF ablation (RF). We evaluated the recurrence rate of atrial arrhythmias at 12 months after VGLB vs. RF and the significance of APT results for the outcome.Methods and Results:Fifty patients with paroxysmal AF were randomized to either RF or VGLB ablation in a 1 : 1 fashion. After PVI each PV underwent an APT. All patients underwent a 3-day Holter and clinical follow-up every 3 months. Significantly less PVs reconnected during APT in the VGLB-arm (10 PV (10.8%) vs. 29 PV (30.9%); P=0.001). Significantly less patients had a recurrence of atrial arrhythmia in the VGLB-arm (3 vs. 9; P=0.047). In the VGLB-arm no recurrence was seen in those patients with a negative APT (negative predictive value (NPV)=100%). Only 3 of the 8 patients with a positive APT in the VGLB-arm had a recurrence (positive PV (PPV)=37%). Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%).
CONCLUSIONS


There was significantly less recurrence of atrial arrhythmias at 12 months after PVI with VGLB. A negative APT after PVI with VGBL predicted freedom from AF with a very high NPV meaning that the high acute efficiency of the VGLB persisted long term.",2020,"Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%).
",['Fifty patients with paroxysmal AF'],"['Adenosine Provocation', 'adenosine provocation test (APT', 'RF or VGLB ablation', 'pulmonary vein isolation (PVI) with visually guided laser balloon ablation (VGLB) than with RF ablation (RF', 'Radiofrequency Ablation', 'Visually Guided Laser Balloon']","['Recurrences', 'recurrence rate of atrial arrhythmias', 'recurrence of atrial arrhythmias', 'Atrial Fibrillation Recurrence', 'recurrence of atrial arrhythmia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}]",8.0,0.0420804,"Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%).
","[{'ForeName': 'Ekrem', 'Initials': 'E', 'LastName': 'Üçer', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fredersdorf', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seegers', 'Affiliation': 'Klinikum Landshut, Internal Medicine I, Cardiology.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Poschenrieder', 'Affiliation': 'Radiology, University Hospital Regensburg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hauck', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Maier', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Jungbauer', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0993']
3308,31357259,Aerobic Training Performed at Ventilatory Threshold Improves Psychological Outcomes in Adolescents With Obesity.,"BACKGROUND


Physical activity may be as effective as some drugs for improving psychological outcomes; however, vigorous exercise may be needed for improving these outcomes in adolescents with obesity. The aim of this study is to examine the effects of low- and high-intensity training on self-esteem and symptoms of depression and anxiety in adolescents with obesity.
METHODS


A total of 62 pubertal adolescents with obesity (age 15 [1.5] y, body mass index 34.87 [4.22] kg/m2) were randomized into high-intensity group (HIG, n = 31) or low-intensity group (LIG, n = 31) for 24 weeks. All participants also received nutritional, psychological, and clinical counseling. Body composition and measures of depressive symptoms, anxiety, and self-esteem were assessed at baseline and after 24 weeks.
RESULTS


Depressive symptoms decreased significantly in both HIG (d = 1.16) and LIG (d = 0.45) (P ≤ .01). Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002). No changes were observed in state anxiety or self-esteem.
CONCLUSIONS


Results from the present study demonstrate that 24 weeks of multidisciplinary intervention improves depression and anxiety symptoms in adolescents with obesity; however, the magnitude of changes is higher in HIG compared with LIG.",2019,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","['adolescents with obesity', '62 pubertal adolescents with obesity (age 15 [1.5]\xa0y, body mass index 34.87 [4.22]\xa0kg/m2', 'Adolescents With Obesity']","['Aerobic Training Performed at Ventilatory Threshold', 'low- and high-intensity training', 'multidisciplinary intervention']","['Psychological Outcomes', 'self-esteem and symptoms of depression and anxiety', 'Trait anxiety', 'Depressive symptoms', 'depression and anxiety symptoms', 'Body composition and measures of depressive symptoms, anxiety, and self-esteem', 'state anxiety or self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",62.0,0.0340544,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","[{'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Fidelix', 'Affiliation': ''}, {'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Lofrano-Prado', 'Affiliation': ''}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': ''}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'do Prado', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0193']
3309,32037380,Lifestyle Modification or Medication to Improve Condition of Patients With Asymptomatic Heart Failure　- Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization II (MOMOTARO II) Study.,"BACKGROUND


In heart failure (HF) patients implanted with high-energy devices, worsening of HF can be diagnosed from intrathoracic impedance (ITI) before symptoms appear. Early therapeutic intervention can prevent HF worsening, but the optimal intervention remains unknown. This study aimed to examine which lifestyle modifications or medications can improve HF indicators in asymptomatic HF patients diagnosed from ITI.Methods and Results:This multicenter, prospective, randomized study included patients with high-energy devices, left ventricular ejection fraction <40%, or with a history of HF hospitalization. After the OptiVol alert was evoked by decreased ITI, patients underwent examinations. If they were diagnosed with HF, they were randomly assigned to 3 groups: lifestyle modification, diuretic, or nitrate. After 1 week, they underwent the same examinations. The primary endpoint was change in ITI and serum B-type natriuretic peptide (BNP). Totally, 57 patients were randomized. In all 3 groups, ITI was significantly increased post-intervention compared with pre-intervention. In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group.
CONCLUSIONS


Compared with lifestyle modifications, diuretic and nitrate therapy for 1 week may be more effective management of HF detected by decreased ITI. However, lifestyle modification may have the additional benefits of reducing the workload or cost.",2020,"In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group.
","['patients with high-energy devices, left ventricular ejection fraction <40%, or with a history of HF hospitalization', 'Patients With Asymptomatic Heart Failure\u3000- Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization II (MOMOTARO II) Study', 'asymptomatic HF patients diagnosed from ITI.Methods\u2004and\u2004Results', '57 patients were randomized']","['diuretic and nitrate therapy', 'lifestyle modification, diuretic, or nitrate', 'Lifestyle Modification or Medication']","['HF indicators', 'change in ITI and serum B-type natriuretic peptide (BNP', 'ITI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0063763', 'cui_str': 'iodo-tyraminyl inulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}]",57.0,0.0259082,"In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group.
","[{'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Kurashiki Central Hospital.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiovascular Medicine, Fukuyama City Hospital.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kawamoto', 'Affiliation': 'Department of Cardiovascular Medicine, National Hospital Organization Iwakuni Clinical Center.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Okawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kagawa Prefectural Central Hospital.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiovascular Medicine, Fukuyama Cardiovascular Hospital.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0986']
3310,32101262,Assessment of Long-term Benefit of Intensive Blood Pressure Control on Residual Life Span: Secondary Analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).,"Importance


High blood pressure (BP) is a leading contributor to premature mortality worldwide. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated a 27% reduction in all-cause death with intensive (vs standard) BP control. However, traditional reporting of survival benefits is not readily interpretable outside medical communities.
Objective


To estimate residual life span and potential survival gains with intensive compared with standard BP control in the SPRINT trial using validated nonparametric age-based methods.
Design, Setting, and Participants


This secondary analysis of data from an open-label randomized clinical trial included data from 102 enrolling clinical sites in the United States. Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013. Data analysis occurred from May 2019 to December 2019.
Interventions


A 1:1 randomization to intensive (target, <120 mm Hg) or standard (target, <140 mm Hg) systolic BP targets.
Main Outcomes and Measures


We calculated age-based estimates of projected survival (at a given age) using baseline age rather than time from randomization as the time axis. In each treatment arm at every year of age, residual life span was estimated using the area under the survival curve, up to a maximum of 95 years. Differences in areas under the survival curves reflect the estimated treatment benefits on projected survival.
Results


A total of 9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals). Mean survival benefits with intensive vs standard BP control ranged from 6 months to up to 3 years. At age 50 years, the estimated residual survival was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years]; P = .008). At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years]; P = .03). Absolute survival gains with intensive vs standard BP control decreased with age, but the relative benefits were consistent (4% to 9%).
Conclusions and Relevance


Intensive BP control improves projected survival by 6 months to 3 years among middle-aged and older adults at high cardiovascular risk but without diabetes mellitus. These post hoc actuarial analyses from SPRINT support the survival benefits of intensive BP control, especially among middle-aged adults at risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT01206062.",2020,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","['Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013', 'middle-aged adults at risk', '9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals', 'middle-aged and older adults at high cardiovascular risk but without diabetes mellitus', 'was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years', 'was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years', '102 enrolling clinical sites in the United States']","['Intensive Blood Pressure Control', 'standard BP control']","['residual survival', 'Absolute survival gains', 'Main Outcomes and Measures\n\n\nWe calculated age-based estimates of projected survival', 'survival benefits', 'blood pressure (BP', 'residual life span and potential survival gains', 'Mean survival benefits', 'Residual Life Span', 'Systolic Blood Pressure Intervention Trial (SPRINT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",9361.0,0.209177,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Section for Research, Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.6192']
3311,31375042,Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes.,"BACKGROUND


The I-HART CGM study has shown that real-time continuous glucose monitoring (rtCGM) has greater beneficial impact on hypoglycemia than intermittently scanned continuous glucose monitoring (iscCGM) in adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections). In this subanalysis, we present the impact of rtCGM and iscCGM on glycemic variability (GV).
METHODS


Forty participants were recruited to this parallel group study. Following two weeks of blinded rtCGM (DexcomG4), participants were randomized to rtCGM (Dexcom G5;  n  = 20) or iscCGM (Freestyle Libre;  n  = 20) for eight weeks. An open-extension phase enabled participants on rtCGM to continue for a further eight weeks and those on iscCGM to switch to rtCGM over this period. Glycemic variability measures at baseline, 8- and 16-week endpoints were compared between groups.
RESULTS


At the eight-week endpoint, between-group differences demonstrated significant reduction in several GV measures with rtCGM compared to iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR];  P  < .05). Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05). At 16 weeks, the iscCGM group switching to rtCGM showed significant improvement in GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR.
CONCLUSION


Our data suggest most, but not all, GV measures improve with rtCGM compared with iscCGM, particularly those measures associated with the risk of hypoglycemia. Selecting appropriate glucose monitoring technology to address GV in this high-risk cohort is important to minimize the risk of glucose extremes and severe hypoglycemia.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03028220.",2020,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05).,"['adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections', 'Forty participants were recruited to this parallel group study', 'Adults With Highest Risk Type 1 Diabetes']","['rtCGM and iscCGM', 'scanned continuous glucose monitoring (iscCGM', 'Continuous Glucose Monitoring', 'rtCGM (Dexcom G5;  n  = 20) or iscCGM']","['glycemic variability (GV', 'iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR', 'risk of hypoglycemia', 'Glycemic Variability and Hypoglycemic Excursions', 'Glycemic variability measures', 'mean average glucose and glycemic variability percentage and GRADE%hyperglycemia', 'GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR', 'several GV measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",40.0,0.0227794,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05).,"[{'ForeName': 'Parizad', 'Initials': 'P', 'LastName': 'Avari', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Moscardo', 'Affiliation': 'Department of Engineering, Universitat Politecnica de Valencia, Spain.'}, {'ForeName': 'Narvada', 'Initials': 'N', 'LastName': 'Jugnee', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}]",Journal of diabetes science and technology,['10.1177/1932296819867688']
3312,30706733,Intervene : Modeling Pro-Social Bystander Behavior in College Students through Online Video.,"This study evaluates the impact of a theory- and empirical evidence- based 20-minute video,  Intervene , on college students' intentions to intervene on behalf of others in multiple problematic situations: an alcohol emergency, emotional distress, hazing, intimate partner violence, racial bias, sexual assault, and sexual harassment. A randomized controlled trial of undergraduate and graduate students ( N  = 1,243) was conducted to determine the effectiveness of the video as an intervention for increasing students' self-reported likelihood to engage in pro-social bystander behavior across these various situations. Results showed that participants who viewed the video online reported higher likelihood at 4 weeks post-viewing to intervene in situations involving hazing, intimate partner violence, racial bias, and sexual harassment than did their control group counterparts.  Intervene  is the first video-based bystander education intervention shown to be effective, even 4 weeks after viewing, at increasing college students' self-reported likelihood to intervene in multiple problematic social situations. Providing access to this free online video represents a cost-effective prevention and communication strategy that can be employed by other colleges and universities.",2020,"Results showed that participants who viewed the video online reported higher likelihood at 4 weeks post-viewing to intervene in situations involving hazing, intimate partner violence, racial bias, and sexual harassment than did their control group counterparts.","['College Students through Online Video', ""college students' intentions to intervene on behalf of others in multiple problematic situations"", 'undergraduate and graduate students (N =\xa01,243']",[],[],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}]",[],[],,0.0341016,"Results showed that participants who viewed the video online reported higher likelihood at 4 weeks post-viewing to intervene in situations involving hazing, intimate partner violence, racial bias, and sexual harassment than did their control group counterparts.","[{'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Santacrose', 'Affiliation': 'Skorton Center for Health Initiatives, Cornell Health, Cornell University.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Laurita', 'Affiliation': 'Skorton Center for Health Initiatives, Cornell Health, Cornell University.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Marchell', 'Affiliation': 'Skorton Center for Health Initiatives, Cornell Health, Cornell University.'}]",Health communication,['10.1080/10410236.2018.1564956']
3313,32086237,"Effect of low-dose atropine on myopia progression, pupil diameter and accommodative amplitude: low-dose atropine and myopia progression.","PURPOSE


To evaluate the effects of 0.01% and 0.02% atropine eye drops on myopia progression, pupil diameter and accommodative amplitude in myopic children.
METHODS


A cohort study assessed 400 myopic children divided into three groups: 138 and 142 children were randomised to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine eye drop applied to both eyes once nightly. Control children (n=120) only wore SV spectacles. Repeated measurements of spherical equivalent refractive errors (SERs), axial length (AL), pupil diameter and accommodative amplitude were performed at baseline, and 4, 8 and 12 months after treatment.
RESULTS


After 12 months, the SER change was -0.38±0.35D, -0.47±0.45D, -0.70±0.60D and AL change was 0.30±0.21 mm, 0.37±0.22 mm, 0.46±0.35 mm in the 0.02%, 0.01% atropine and control groups, respectively. There were significant differences in the change in AL and SER between three groups (all p<0.001). Between baseline and the 12-month visit, the overall change in accommodative amplitude was 1.50±0.25D, 1.61±0.31D and change in pupil diameter was 0.78±0.42 mm, 0.69±0.39 mm, with 0.02% and 0.01% atropine, respectively. Accommodative amplitude significantly decreased and pupil diameter significantly increased in two atropine groups (all p<0.001). Moreover, there was no statistical difference in the change difference in accommodative amplitude and pupil diameter between two atropine groups (p=0.24, p=0.38), whereas the accommodative amplitude (p=0.45) and pupil diameter (p=0.39) in the control group remained stable.
CONCLUSIONS


0.02% atropine eye drops had a better effect on myopia progression than 0.01% atropine, but 0.02% and 0.01% atropine showed similar effects on pupil diameter and accommodative amplitude after 12 months of treatment.
TRIAL REGISTRATION NUMBER


ChiCTR-IPD-16008844.",2020,There were significant differences in the change in AL and SER between three groups (all p<0.001).,"['400 myopic children divided into three groups: 138 and 142 children', 'myopic children', 'Control children (n=120) only wore SV spectacles']","['atropine eye', 'atropine eye drops', 'atropine', 'low-dose atropine']","['myopia progression, pupil diameter and accommodative amplitude', 'spherical equivalent refractive errors (SERs), axial length (AL), pupil diameter and accommodative amplitude', 'Accommodative amplitude', 'pupil diameter', 'myopia progression', 'change in AL and SER', 'accommodative amplitude', 'accommodative amplitude and pupil diameter', 'pupil diameter and accommodative amplitude', 'SER change', 'accommodative amplitude (p=0.45) and pupil diameter']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",400.0,0.297345,There were significant differences in the change in AL and SER between three groups (all p<0.001).,"[{'ForeName': 'Aicun', 'Initials': 'A', 'LastName': 'Fu', 'Affiliation': 'Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'Optometry, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Weiqun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Watt', 'Affiliation': 'Optometry, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': 'The Affiliated Eye Hospital of Suzhou Vocational Health College, Suzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China lyong@zzu.edu.cn.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315440']
3314,32073990,"A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy in Patients with Lower Limb Lymphedema.","Background:  Platelet-rich plasma (PRP) is an autologous concentrated preparation of platelets characterized by lymphangiogenetic and tissue-repairing effects. Although PRP has been safely used in many different fields, there is no clinical study regarding the use of PRP in lymphedema treatment in humans. We assessed the clinical outcomes of PRP in patients with lower extremity lymphedema (LEL) in a randomized controlled trial.  Methods and Results:  Patients with secondary LEL were randomly allocated to one of three groups consisting of treatment with PRP with complex decongestive physiotherapy (PRP+CDP group), low-level laser therapy with CDP (LLLT+CDP group), and only CDP (CDP group). Assessment of Lymphedema Quality of-Life Questionnaire (LYMQOL) for health-related quality of life, lower-extremity-circumference (LEC) for edema, tissue dielectric constant (TDC) for extremity volume, 6-minute walking test (6MWT) for functional capacity, and numeric rating scale (NRS) scoring for extremity fullness were evaluated both before and after treatment. Forty-five patients (68.8% female) with mean age 40.84 ± 15.81 years were included in the study. Significant differences in LYMQOL, LEC, NRS, and TDC values both before and after treatment were found in all groups; however, there were no statistically significant difference in values between the three groups. In the PRP+CDP group, LYMQOL values had a larger effect size than the other two groups. Significant differences in 6MWT values both before and after treatment were found in PRP+CDP and LLLT+CDP groups; however, there was no statistically significant difference in the CDP group.  Conclusion:  This is the first clinical study to evaluate the usage of PRP in patients with secondary LEL. PRP might be an additional treatment option of lymphedema management; however, more clinical trials in humans are needed to yield more evidence in the usage of PRP in patients with lymphedema.",2020,"Significant differences in 6MWT values both before and after treatment were found in PRP+CDP and LLLT+CDP groups; however, there was no statistically significant difference in the CDP group.  ","['patients with secondary LEL', 'patients with lower extremity lymphedema (LEL', 'Patients with Lower Limb Lymphedema', 'patients with lymphedema', 'Patients with secondary LEL', 'Forty-five patients (68.8% female) with mean age 40.84\u2009±\u200915.81 years were included in the study']","['Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy', 'PRP', 'Platelet-rich plasma (PRP', 'PRP+CDP', 'PRP with complex decongestive physiotherapy (PRP+CDP group), low-level laser therapy with CDP (LLLT+CDP group), and only CDP (CDP group']","['LYMQOL, LEC, NRS, and TDC values', '6MWT values', 'LYMQOL values', 'Lymphedema Quality of-Life Questionnaire (LYMQOL) for health-related quality of life, lower-extremity-circumference (LEC) for edema, tissue dielectric constant (TDC) for extremity volume, 6-minute walking test (6MWT) for functional capacity, and numeric rating scale (NRS) scoring for extremity fullness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0222045'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}]",45.0,0.0549702,"Significant differences in 6MWT values both before and after treatment were found in PRP+CDP and LLLT+CDP groups; however, there was no statistically significant difference in the CDP group.  ","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akgul', 'Affiliation': 'Division of Gerontology, Faculty of Health Sciences, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Ist-GETAM, Center of Gerontechnology, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Ist-GETAM, Center of Gerontechnology, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Civi', 'Affiliation': 'Ist-GETAM, Center of Gerontechnology, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Irmak', 'Affiliation': 'Division of Gerontology, Faculty of Health Sciences, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0064']
3315,31050562,Myofascial release in patients during the early postoperative period after revascularisation of coronary arteries.,"Purpose:  The evaluation of the impact of soft tissue manual therapy with a myofascial release on pulmonary function, postoperative pain, fatigue, breathing difficulties and physical fitness, in patients during the early postoperative period after coronary artery bypass grafting and off-pump coronary artery bypass grafting surgery. Materials and methods:  The study included 80 subjects (59 males) with an average age of 64.13 years old. They were randomised into two groups: group I ( n  = 40) received a conventional form of rehabilitation and group II ( n  = 40) additionally, from day 3 to day 6 post-surgery, was provided the Carol Manheim form of myofascial release. Subjects were evaluated three times: before the surgery, on day 4 and 6 post-surgery. Using the visual analogue scale, the following symptoms were measured: pain intensity, breathing difficulties and level of physical endurance. Fatigue after performing physical exercises was measured using the Borg scale. Spirometry was used to measure the one-second forced expiratory volume and forced vital capacity. Results:  Positive changes were observed in both groups with regard to all analysed variables. However, group II compared to group I showed a significantly greater improvement ( p  < 0.05; the Mann-Whitney  U  test) in relation to: pain intensity on day 4 (mean 5.46 vs 6.58) and on day 6 (mean 3.05 vs 5.35) after the surgery; lower breathing difficulties on day 6 post-surgery (mean 4.08 vs 5.63); limiting physical fitness on day 6 post-surgery (mean 6.35 vs 5.13). Between the condition prior to the surgery and day 6 post-surgery in group II compared to group I, there was a significantly smaller ( p  < 0.05; Student's t-test) decrease in one-second forced expiratory volume (mean -0.65 vs -0.9 L/s) and the volume of forced vital capacity (mean -0.63 vs -1.33 L). Between day 4 and 6 post-surgery in group II compared to group I, there was a significantly higher ( p  < 0.05; Student's  t -test) increase in the one-second forced expiratory volume (mean 0.21 vs 0.11 L/s) and forced vital capacity (mean 0.32 vs 0.12 L). Conclusions:  Implementing myofascial release techniques in the conventional form of cardiosurgical rehabilitation might enhance the improvement in pulmonary function, lessen breathing difficulties, pain intensity and fatigue, it might augment the increase in physical endurance among patients during the early postoperative period after coronary artery bypass grafting and off-pump coronary artery bypass grafting surgery.Implications for rehabilitationThe implementation of myofascial release techniques in conventional cardiac rehabilitation may improve the pulmonary function in patients during the early postoperative period, after revascularisation of coronary arteries.The adoption of myofascial release techniques in conventional cardiac rehabilitation may decrease breathing difficulties, pain intensity, fatigue and increase the physical fitness in patients during the early postoperative period, after the revascularisation of the coronary arteries.The implementation of myofascial release techniques in conventional cardiac rehabilitation may enhance patients' improvement during the early postoperative period, after the revascularisation of the coronary arteries.",2020,"However, group II compared to group I showed a significantly greater improvement (p < 0.05; the Mann-Whitney U test) in relation to: pain intensity on day 4 (mean 5.46 vs 6.58) and on day 6 (mean 3.05 vs 5.35) after the surgery; lower breathing difficulties on day 6 post-surgery (mean 4.08 vs 5.63); limiting physical fitness on day 6 post-surgery (mean 6.35 vs 5.13).","['80 subjects (59 males) with an average age of 64.13 years old', 'patients during the early postoperative period, after revascularisation of coronary arteries', 'patients during the early postoperative period after', 'patients during the early postoperative period after coronary artery bypass grafting and off-pump coronary artery bypass grafting surgery', 'patients during the early postoperative period after revascularisation of coronary arteries']","['soft tissue manual therapy', 'coronary artery bypass grafting and off-pump coronary artery bypass grafting surgery', 'conventional form of rehabilitation', 'conventional cardiac rehabilitation']","['pulmonary function', 'pain intensity, breathing difficulties and level of physical endurance', 'breathing difficulties', 'volume of forced vital capacity', 'Myofascial release', 'physical endurance', 'limiting physical fitness', 'one-second forced expiratory volume', 'pain intensity', 'Fatigue', 'pulmonary function, postoperative pain, fatigue, breathing difficulties and physical fitness', 'breathing difficulties, pain intensity, fatigue and increase the physical fitness', 'forced vital capacity']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031808', 'cui_str': 'Physical Stamina'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",80.0,0.0199579,"However, group II compared to group I showed a significantly greater improvement (p < 0.05; the Mann-Whitney U test) in relation to: pain intensity on day 4 (mean 5.46 vs 6.58) and on day 6 (mean 3.05 vs 5.35) after the surgery; lower breathing difficulties on day 6 post-surgery (mean 4.08 vs 5.63); limiting physical fitness on day 6 post-surgery (mean 6.35 vs 5.13).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ratajska', 'Affiliation': 'Department of Cardiovascular Surgery, Strus Hospital Poznan, Poznan, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Chochowska', 'Affiliation': 'Department of Rehabilitation, Poznan University School of Physical Education, Gorzow Wielkopolski, Poland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kulik', 'Affiliation': 'Department of Rehabilitation, Poznan University School of Physical Education, Gorzow Wielkopolski, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bugajski', 'Affiliation': 'Department of Cardiovascular Surgery, Strus Hospital Poznan, Poznan, Poland.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1593518']
3316,32085907,"Individual differences in the neurobiology of fluid intelligence predict responsiveness to training: Evidence from a comprehensive cognitive, mindfulness meditation, and aerobic exercise intervention.","BACKGROUND


Fluid intelligence (G f ) is a critical cognitive ability that is predictive of real-world outcomes, and it has been a persistent aim to characterize its neural architecture.
PROCEDURE


We advance our prior research by applying latent class analysis to evaluate individual differences in the neural and cognitive foundations of G f  over the course of a 16-week randomized, multi-modal intervention trial in neurologically healthy, younger adults (N = 424).
RESULTS


Controlling for pre-intervention ability, three latent classes described individual performance at post-intervention and one group (n = 71) showed greater gains in visuospatial reasoning and high performance at post-intervention. The high performance group was predicted by larger anterior cingulate cortex, caudate and hippocampus volumes, and smaller middle frontal, insula and parahippocampal cortex volumes.
CONCLUSION


Regions that support cognitive control, working memory, and relational processes differentiated individuals who had higher G f  ability at pre-intervention and demonstrated a cumulative better response to the intervention.",2020,"The high performance group was predicted by larger anterior cingulate cortex, caudate and hippocampus volumes, and smaller middle frontal, insula and parahippocampal cortex volumes.
","['neurologically healthy, younger adults (N\u202f=\u202f424']",['aerobic exercise intervention'],"['larger anterior cingulate cortex, caudate and hippocampus volumes, and smaller middle frontal, insula and parahippocampal cortex volumes', 'gains in visuospatial reasoning and high performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0318462,"The high performance group was predicted by larger anterior cingulate cortex, caudate and hippocampus volumes, and smaller middle frontal, insula and parahippocampal cortex volumes.
","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Daugherty', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, MI, USA; Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, MI, USA; Institute of Gerontology, Wayne State University, Detroit, MI, USA; Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, 405 North Mathews Avenue, Urbana, IL 61801, USA. Electronic address: ana.daugherty@wayne.edu.'}, {'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, 405 North Mathews Avenue, Urbana, IL 61801, USA; Department of Bioengineering, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA; Office of the Provost, Northeastern University, Boston, MA, USA; Department of Mechanical & Industrial Engineering, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Cohen', 'Affiliation': 'Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, 405 North Mathews Avenue, Urbana, IL 61801, USA; Department of Psychology, University of Illinois, Urbana, IL, USA; Neuroscience Program, University of Illinois, Urbana, IL, USA; Center for Brain Plasticity, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Aron K', 'Initials': 'AK', 'LastName': 'Barbey', 'Affiliation': 'Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, 405 North Mathews Avenue, Urbana, IL 61801, USA; Department of Bioengineering, University of Illinois, Urbana, IL, USA; Department of Psychology, University of Illinois, Urbana, IL, USA; Neuroscience Program, University of Illinois, Urbana, IL, USA; Center for Brain Plasticity, University of Illinois, Urbana, IL, USA. Electronic address: barbey@illinois.edu.'}]",Trends in neuroscience and education,['10.1016/j.tine.2019.100123']
3317,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3318,31975316,Red clover and lifestyle changes to contrast menopausal symptoms in premenopausal patients with hormone-sensitive breast cancer receiving tamoxifen.,"PURPOSE


To determine whether a red clover preparation plus dietary intervention administered to premenopausal women with breast cancer (BC), improves menopausal symptoms due to anti-oestrogen treatment, and hence promotes compliance with tamoxifen, prevents weight gain and is safe.
METHODS


Surgically-treated premenopausal women with oestrogen receptor (ER) positive disease taking tamoxifen were recruited to a prospective double-blind randomized trial (NCT03844685). The red clover group (N = 42) received one oral tablet/day (Promensil ®  Forte) containing 80 mg red clover extract for 24 months. The placebo group (N = 39) received one oral tablet/day without active ingredient. All women were encouraged to follow a Mediterranean-type diet and keep active. Outcomes were Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones. As safety indicators, endometrial thickness, breast density, and effects of patient serum on ER-positive BC cell lines were investigated.
RESULTS


MRS reduced significantly (p < 0.0001) with no between-group difference (p = 0.69). The red clover group had significantly greater reductions in BMI and waist circumference (p < 0.0001 both cases). HDL cholesterol increased significantly in both groups (p = 0.01). Hormone levels and insulin resistance changed little. Endometrial thickness remained constant (p = 0.93). Breast density decreased significantly in both groups (p < 0.0001). Proliferation and oestrogen-regulated gene expression didn't differ in cell lines treated with serum from each group.
CONCLUSIONS


This is the first trial to assess red clover in BC patients on tamoxifen. The preparation proved safe clinically and in vitro, and was associated with reduced BMI and waist circumference, but the diet-lifestyle intervention probably improved the menopausal symptoms.",2020,The red clover group had significantly greater reductions in BMI and waist circumference (p < 0.0001 both cases).,"['premenopausal patients with hormone-sensitive breast cancer receiving', 'BC patients on', 'premenopausal women with breast cancer (BC', 'Surgically-treated premenopausal women with oestrogen receptor (ER) positive disease taking']","['one oral tablet/day without active ingredient', 'oral tablet/day (Promensil ®  Forte) containing 80\xa0mg red clover extract', 'tamoxifen', 'red clover preparation plus dietary intervention', 'placebo']","['safety indicators, endometrial thickness, breast density, and effects of patient serum on ER-positive BC cell lines', 'Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones', 'Endometrial thickness', 'reduced BMI and waist circumference', 'menopausal symptoms', 'Breast density', 'weight gain and is safe', 'HDL cholesterol', 'Proliferation and oestrogen-regulated gene expression', 'Hormone levels and insulin resistance', 'BMI and waist circumference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0993159', 'cui_str': 'Oral Tablet'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1454291', 'cui_str': 'Promensil'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0939844', 'cui_str': 'Red Clover Preparation'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1659543', 'cui_str': 'Breast Density'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007600', 'cui_str': 'Cell Line'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.222456,The red clover group had significantly greater reductions in BMI and waist circumference (p < 0.0001 both cases).,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ferraris', 'Affiliation': 'Breast Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ballestra', 'Affiliation': 'Breast Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Listorti', 'Affiliation': 'Breast Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy. chiara.listorti@istitutotumori.mi.it.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cappelletti', 'Affiliation': 'Biomarker Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Reduzzi', 'Affiliation': 'Biomarker Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Gianfranco P', 'Initials': 'GP', 'LastName': 'Scaperrotta', 'Affiliation': 'Breast Radiology, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Pulice', 'Affiliation': ""Clinical Studies Scientific Director's Office, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.""}, {'ForeName': 'Eleonora G A', 'Initials': 'EGA', 'LastName': 'Ferrari', 'Affiliation': 'Pharmacy and Experimental Clinical Studies, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Secondo', 'Initials': 'S', 'LastName': 'Folli', 'Affiliation': 'Breast Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Clinical Epidemiology and Trials Organization, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Breast Unit, Fondazione IRCCS, Istituto Nazionale Dei Tumori Di Milano, Via Venezian 1, 20133, Milano, Italy.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05534-4']
3319,31383945,Umbilical venous catheter insertion depth estimation using birth weight versus surface measurement formula: a randomized controlled trial.,"OBJECTIVE


To determine if umbilical venous catheter (UVC) insertion depth estimated by surface measurement (SM) results in optimal catheter tip position on ultrasound as compared with formula using birth weight (BW).
METHODS


In this randomized controlled trial, eligible infants were randomized to UVC insertion depth estimated by SM or BW method. We compared proportion of optimum UVC position on ultrasound read by neonatologist masked with group assignment.
RESULTS


UVC was inserted to estimated depth in 164 of 200 enroled infants. There was no difference in the proportion of correctly positioned UVCs between the groups (SM 33/82 (40.2%) vs BW 27/82 (32.9%), p = 0.33). Among BW < 1000 g, SM method had higher correctly positioned UVC (43.7% vs 22.5%, p = 0.07).
CONCLUSION


There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth. However, SM method results in more optimal positioning of UVC tip among BW < 1000 g infants.",2020,There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth.,"['164 of 200 enroled infants', 'eligible infants']","['Umbilical venous catheter insertion depth estimation using birth weight versus surface measurement formula', 'umbilical venous catheter (UVC) insertion depth estimated by surface measurement (SM']","['rate of optimally positioned UVC tip', 'proportion of correctly positioned UVCs', 'correctly positioned UVC']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]","[{'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",,0.218732,There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth.,"[{'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Sheta', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Majeeda', 'Initials': 'M', 'LastName': 'Kamaluddeen', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. asoraish@ucalgary.ca.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0456-0']
3320,32077470,GIP and GLP-1 Receptor Antagonism During a Meal in Healthy Individuals.,"CONTEXT


The actions of both endogenous incretin hormones during a meal have not previously been characterized.
OBJECTIVE


Using specific receptor antagonists, we investigated the individual and combined contributions of endogenous glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) to postprandial glucose metabolism, energy expenditure, and gallbladder motility.
DESIGN


Randomized, double-blinded, placebo-controlled, crossover design.
SETTING


On four separate days, four liquid mixed meal tests (1894 kJ) over 270 minutes (min).
PATIENTS OR OTHER PARTICIPANTS


Twelve healthy male volunteers.
INTERVENTIONS


Infusions of the GIP receptor antagonist GIP(3-30)NH2 (800 pmol/kg/min), the GLP-1 receptor antagonist exendin(9-39)NH2 (0-20 min: 1000 pmol/kg/min; 20-270 min: 450 pmol/kg/min), GIP(3-30)NH2+exendin(9-39)NH2, or placebo/saline.
MAIN OUTCOME MEASURE


Baseline-subtracted area under the curve (bsAUC) of C-peptide.
RESULTS


Infusion of GIP(3-30)NH2+exendin(9-39)NH2 significantly increased plasma glucose excursions (bsAUC: 261 ± 142 mmol/L × min) during the liquid mixed meals compared with GIP(3-30)NH2 (180 ± 141 mmol/L × min; P = 0.048), exendin(9-39)NH2 (171 ± 114 mmol/L × min; P = 0.046), and placebo (116 ± 154 mmol/L × min; P = 0.015). Correspondingly, C-peptide:glucose ratios during GIP(3-30)NH2+exendin(9-39)NH2 infusion were significantly lower than during GIP(3-30)NH2 (P = 0.0057), exendin(9-39)NH2 (P = 0.0038), and placebo infusion (P = 0.014). GIP(3-30)NH2 resulted in significantly lower AUCs for glucagon than exendin(9-39)NH2 (P = 0.0417). Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004). For all interventions, energy expenditure and respiratory quotient were similar.
CONCLUSIONS


Endogenous GIP and GLP-1 lower postprandial plasma glucose excursions and stimulate insulin secretion but only endogenous GIP affects gallbladder motility. The two incretin hormones potentiate each other's effects in the control of postprandial glycemia in healthy men.",2020,Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004).,"['healthy men', 'Healthy Individuals', 'Twelve healthy male volunteers']","['placebo', 'GIP(3-30)NH2+exendin(9-39)NH2, or placebo/saline', 'GIP receptor antagonist GIP(3-30)NH2', 'GIP(3-30)NH2+exendin(9-39)NH2', 'GIP and GLP-1 Receptor Antagonism', 'endogenous glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1']","['postprandial glycemia', 'Gallbladder ejection fraction', 'Baseline-subtracted area under the curve (bsAUC) of C-peptide', 'postprandial plasma glucose excursions', 'energy expenditure and respiratory quotient', 'Correspondingly, C-peptide:glucose ratios', 'plasma glucose excursions']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0061126', 'cui_str': 'glucose-dependent insulinotropic polypeptide receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4507209', 'cui_str': 'glucose insulinotropic polypeptide(3-30)amide'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",12.0,0.211064,Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004).,"[{'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Sparre-Ulrich', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz175']
3321,30039776,Variation in care for infants undergoing the Stage II palliation for hypoplastic left heart syndrome.,"BACKGROUND


The Single Ventricle Reconstruction trial randomised neonates with hypoplastic left heart syndrome to a systemic-to-pulmonary-artery shunt strategy. Patients received care according to usual institutional practice. We analysed practice variation at the Stage II surgery to attempt to identify areas for decreased variation and process control improvement.
METHODS


Prospectively collected data were available in the Single Ventricle Reconstruction public-use database. Practice variation across 14 centres was described for 397 patients who underwent Stage II surgery. Data are centre-level specific and reported as interquartile ranges across all centres, unless otherwise specified.
RESULTS


Preoperative Stage II median age and weight across centres were 5.4 months (interquartile range 4.9-5.7) and 5.7 kg (5.5-6.1), with 70% performed electively. Most patients had pre-Stage-II cardiac catheterisation (98.5-100%). Digoxin was used by 11/14 centres in 25% of patients (23-31%), and 81% had some oral feeds (68-84%). The majority of the centres (86%) performed a bidirectional Glenn versus hemi-Fontan. Median cardiopulmonary bypass time was 96 minutes (75-113). In aggregate, 26% of patients had deep hypothermic circulatory arrest >10 minutes. In 13/14 centres using deep hypothermic circulatory arrest, 12.5% of patients exceeded 10 minutes (8-32%). Seven centres extubated 5% of patients (2-40) in the operating room. Postoperatively, ICU length of stay was 4.8 days (4.0-5.3) and total length of stay was 7.5 days (6-10).
CONCLUSIONS


In the Single Ventricle Reconstruction Trial, practice varied widely among centres for nearly all perioperative factors surrounding Stage II. Further analysis may facilitate establishing best practices by identifying the impact of practice variation.",2018,"Postoperatively, ICU length of stay was 4.8 days (4.0-5.3) and total length of stay was 7.5 days (6-10).
","['neonates with hypoplastic left heart syndrome to a systemic-to-pulmonary-artery shunt strategy', '397 patients who underwent Stage II surgery', 'Prospectively collected data were available in the Single Ventricle Reconstruction public-use database', 'infants undergoing the Stage II palliation for hypoplastic left heart syndrome']",['Digoxin'],"['Median cardiopulmonary bypass time', 'Postoperatively, ICU length of stay', 'total length of stay']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0183290', 'cui_str': 'Pulmonary artery shunt'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle (disorder)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",397.0,0.119744,"Postoperatively, ICU length of stay was 4.8 days (4.0-5.3) and total length of stay was 7.5 days (6-10).
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Eckhauser', 'Affiliation': ""1Department of Surgery,Division of Cardiothoracic Surgery,Section of Pediatric Cardiothoracic Surgery,University of Utah,Primary Children's Hospital,Salt Lake City,UT,USA.""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Pasquali', 'Affiliation': ""2Department of Pediatrics,Division of Pediatric Cardiology,University of Michigan,C.S. Mott Children's Hospital,Ann Arbor,MI,USA.""}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""3Department of Pediatrics,Division of Pediatric Cardiology,Children's Hospital of Philadelphia,Philadelphia,PA,USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""1Department of Surgery,Division of Cardiothoracic Surgery,Section of Pediatric Cardiothoracic Surgery,University of Utah,Primary Children's Hospital,Salt Lake City,UT,USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""4Department of Cardiology,Boston Children's Hospital,Boston,MA,USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': '6Department of Pediatrics,Division of Cardiology,Medical University of South Carolina,Charleston,SC,USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ghanayem', 'Affiliation': ""7Department of Pediatrics,Division of Pediatric Critical Care,Baylor College of Medicine,Texas Children's Hospital,Houston,TX,USA.""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Schwartz', 'Affiliation': '8Departments of Critical Care Medicine and Paediatrics,Divisions of Cardiac Critical Care Medicine and Cardiology,University of Toronto,The Hospital for Sick Children,Toronto,CA,USA.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': '9Division of Epidemiology,University of Utah,Salt Lake City,UT,USA.'}, {'ForeName': 'Jeffery P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""10Department of Surgery,Division of Cardiovascular Surgery,John's Hopkins University,Johns Hopkins All Children's Hospital,St. Petersburg,FL,USA.""}, {'ForeName': 'L LuAnn', 'Initials': 'LL', 'LastName': 'Minich', 'Affiliation': ""1Department of Surgery,Division of Cardiothoracic Surgery,Section of Pediatric Cardiothoracic Surgery,University of Utah,Primary Children's Hospital,Salt Lake City,UT,USA.""}]",Cardiology in the young,['10.1017/S1047951118000999']
3322,31650182,"Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women.","CONTEXT


Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist recently approved for the treatment of endometriosis-associated pain and being developed for heavy menstrual bleeding associated with uterine fibroids.
OBJECTIVE


The objective was to evaluate the effects of elagolix on ovulation and ovarian sex hormones.
DESIGN AND SETTING


This was a randomized, open-label, multicenter study.
PARTICIPANTS


Participants were healthy ovulatory women aged 18 to 40 years.
INTERVENTIONS


Elagolix was administered orally for 3 continuous 28-day dosing intervals at 100 to 200 mg once daily (QD), 100 to 300 mg twice daily (BID), and 300 mg BID plus estradiol/norethindrone acetate (E2/NETA) 1/0.5 mg QD.
MAIN OUTCOME MEASURES


The main outcomes measures were ovulation rates measured by transvaginal ultrasound, progesterone concentrations, and hormone suppression.
RESULTS


Elagolix suppressed ovulation in a dose-dependent manner. The percentage of women who ovulated was highest at 100 mg QD (78%), intermediate at 150 and 200 mg QD and 100 mg BID (47%-57%), and lowest at 200 and 300 mg BID (32% and 27%, respectively). Addition of E2/NETA to elagolix 300 mg BID further suppressed the ovulation rate to 10%. Elagolix also suppressed luteinizing hormone and follicle stimulating hormone in a dose-dependent manner, leading to dose-dependent suppression of estradiol and progesterone. Elagolix had no effect on serum biomarker of ovarian reserve, and reduced endometrial thickness compared to the screening cycle.
CONCLUSION


Women being treated with elagolix may ovulate and should use effective methods of contraception. The rate of ovulation was lowest with elagolix 300 mg BID plus E2/NETA 1/0.5 mg QD.",2020,"Elagolix had no effect on serum biomarker of ovarian reserve, and reduced endometrial thickness compared to the screening cycle.
","['ovulatory women', 'Participants were healthy ovulatory women aged 18 to 40 years']","['estradiol/norethindrone acetate (E2/NETA', 'Elagolix', 'elagolix', 'gonadotropin-releasing hormone (GnRH) antagonist']","['Elagolix suppressed ovulation', 'luteinizing hormone (LH) and follicle stimulating hormone (FSH', 'ovulation rate', 'Elagolix suppresses ovulation', 'ovulation rates measured by transvaginal ultrasound, progesterone concentrations, and hormone suppression', 'rate of ovulation', 'serum biomarker of ovarian reserve, and reduced endometrial thickness']","[{'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0717754', 'cui_str': 'Estradiol / Norethindrone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.0928221,"Elagolix had no effect on serum biomarker of ovarian reserve, and reduced endometrial thickness compared to the screening cycle.
","[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics & Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Juki', 'Initials': 'J', 'LastName': 'Ng', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Kristof', 'Initials': 'K', 'LastName': 'Chwalisz', 'Affiliation': 'General Medicine, AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Yi-Lin', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Eve C', 'Initials': 'EC', 'LastName': 'Feinberg', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Miller', 'Affiliation': 'The Advanced IVF Institute, Naperville, Illinois.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Feldman', 'Affiliation': 'Baptist Health Medical Group, Miami, Florida.'}, {'ForeName': 'Cheri E', 'Initials': 'CE', 'LastName': 'Klein', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz086']
3323,31371154,Haemostasis in oral surgical procedures involving patients with a ventricular assist device.,"The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required.",2020,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","['patients with VADs, while the third group included cardiovascular patients without VADs who served as controls', 'patients undergoing oral surgery', 'patients with ventricular assist devices (VADs', 'patients with a ventricular assist device']","['local anaesthesia without sedation', 'topical haemostatic agents (oxidized cellulose or collagen', 'fibrin glue']","['incidence of haemorrhage', 'haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0222906,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany. Electronic address: hamzah@medizin.uni-leipzig.de.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Graf', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Meyer', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Dieterlen', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemprich', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.07.009']
3324,31331292,The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings.,"BACKGROUND


Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support.
METHODS


This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm.
DISCUSSION


This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.",2019,"Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.
","['Patient participants to be recruited in phase 2 will be followed longitudinally until 13\u2009months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40\u2009weeks gestation, or 1-3\u2009months postpartum']",['Massachusetts Child Psychiatry Access Program (MCPAP'],"['depression symptomatology', 'rates of depressive symptoms', 'feasibility, acceptance, efficacy, and sustainability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0008088', 'cui_str': 'Child Psychiatry'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.155807,"Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.
","[{'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Moore Simas', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA. TiffanyA.MooreSimas@UMassMemorial.org.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Brenckle', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Sankaran', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Masters', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Sharina', 'Initials': 'S', 'LastName': 'Person', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Weinreb', 'Affiliation': 'Department of Family Medicine and Community Health, University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Jean Y', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Robbins', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jeroan', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Byatt', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2387-3']
3325,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
3326,32068870,Low-Dose Naltrexone for the Treatment of Fibromyalgia: Investigation of Dose-Response Relationships.,"OBJECTIVE


This study explores dose-response relationships when treating fibromyalgia with low-dose naltrexone.
DESIGN


A single-blinded clinical trial was carried out using the ""up-and-down"" method.
SUBJECTS


Subjects included women with a diagnosis of fibromyalgia aged 18-60 years who had been referred to treatment at a public pain clinic at a Danish university hospital.
METHODS


The test doses were in the range 0.75-6 mg, and the dosing interval was 0.75 mg. The method was sequential and allowed predicting the dose effective in 50% (ED50) and 95% (ED95) of the subjects when the dose had shifted direction 10 times, and six pairs of ""up-and-down"" data were available.
RESULTS


A total of 27 subjects were included in the study; two subjects were withdrawn. After inclusion of 25 evaluable subjects, the dose estimates were calculated as 3.88 mg for ED50 and 5.40 mg for ED95. As a secondary outcome, the effects on 10 common fibromyalgia symptoms were evaluated. A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
CONCLUSIONS


This study is the first to explore dose-response relationships in the treatment of fibromyalgia with low-dose naltrexone. Future placebo-controlled randomized clinical trials are needed, and according to our findings, 4.5 mg, which has previously been used, seems to be a relevant test dose. We recommend that future studies include additional nonpain fibromyalgia symptoms as outcome measures.",2020,"A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
","['A total of 27 subjects were included in the study; two subjects were withdrawn', 'Subjects included women with a diagnosis of fibromyalgia aged 18-60\u2009years who had been referred to treatment at a public pain clinic at a Danish university hospital']","['placebo', 'naltrexone', 'Naltrexone']",['10 common fibromyalgia symptoms'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.165937,"A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bruun-Plesner', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Morten Rune', 'Initials': 'MR', 'LastName': 'Blichfeldt-Eckhardt', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Henrik Bjarke', 'Initials': 'HB', 'LastName': 'Vaegter', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Joergen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Amris', 'Affiliation': 'Department of Rheumatology, The Parker Institute, Copenhagen University Hospital, Bispebjerg-Frederiksberg, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa001']
3327,31805012,Oral N-acetylcysteine improves cone function in retinitis pigmentosa patients in phase I trial.,"BACKGROUNDIn retinitis pigmentosa (RP), rod photoreceptors degenerate from 1 of many mutations, after which cones are compromised by oxidative stress. N-acetylcysteine (NAC) reduces oxidative damage and increases cone function/survival in RP models. We tested the safety, tolerability, and visual function effects of oral NAC in RP patients.METHODSSubjects (n = 10 per cohort) received 600 mg (cohort 1), 1200 mg (cohort 2), or 1800 mg (cohort 3) NAC bid for 12 weeks and then tid for 12 weeks. Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC were measured. Linear mixed-effects models were used to estimate the rates of changes during the treatment period.RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid). During the 24-week treatment period, mean BCVA significantly improved at 0.4 (95% CI: 0.2-0.6, P < 0.001), 0.5 (95% CI: 0.3-0.7, P < 0.001), and 0.2 (95% CI: 0.02-0.4, P = 0.03) letters/month in cohorts 1, 2, and 3, respectively. There was no significant improvement in mean sensitivity over time in cohorts 1 and 2, but there was in cohort 3 (0.15 dB/month, 95% CI: 0.04-0.26). There was no significant change in mean EZ width in any cohort.CONCLUSIONOral NAC is safe and well tolerated in patients with moderately advanced RP and may improve suboptimally functioning macular cones. A randomized, placebo-controlled trial is needed to determine if oral NAC can provide long-term stabilization and/or improvement in visual function in patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr. and Mrs. Robert Wallace, Mr. and Mrs. Jonathan Wallace, Rami and Eitan Armon, Marc Sumerlin, Cassandra Hanley, and Nacuity Pharmaceuticals, Inc.",2020,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"['retinitis pigmentosa (RP', 'RP patients', 'patients with moderately advanced RP', 'patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr', 'retinitis pigmentosa patients']","['Oral N-acetylcysteine', 'placebo', 'oral NAC', 'NAC', 'N-acetylcysteine (NAC']","['gastrointestinal adverse events', 'mean sensitivity', 'cone function', 'visual function', 'Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC', 'mean BCVA', 'safety, tolerability, and visual function effects', 'mean EZ width', 'safe and well tolerated']","[{'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.250889,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Campochiaro', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Gulnar', 'Initials': 'G', 'LastName': 'Hafiz', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Akhlaq', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Tsai', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Wehling', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Wall', 'Affiliation': 'Nacuity Pharmaceuticals, Inc., Fort Worth, Texas, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Singh', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Xiangrong', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Wilmer Eye Institute and.'}]",The Journal of clinical investigation,['10.1172/JCI132990']
3328,32071367,Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial.,"OBJECTIVE


In preterm neonates fed human milk, fortification may be adjusted by (1) optimization, based on growth rate and serum nutrient analyses, or (2) individualization, based on serial milk nutrient analyses. The primary aim was to determine whether individualized plus optimized nutrition (experimental) improves velocity of weight gain and linear growth from birth to endpoint (36 weeks postmenstrual age or discharge) when compared with optimized nutrition alone (controls).
STUDY DESIGN


Double-blinded parallel group randomized trial in 120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight < 10th centile).
RESULT


Weight-gain velocity (13.1 ± 2.1, n = 57 controls, vs. 13.0 ± 2.6 g kg -1  day -1 , n = 59 experimental, P = 0.87), linear growth (0.9 ± 0.2, n = 55, vs. 0.9 ± 0.2 cm week -1 , n = 52, P = 0.90) and frequency of weight/length disproportion (2% vs. 2%, P = 0.98) were similar in both groups.
CONCLUSIONS


Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.",2020,"Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.","['preterm very low birth weight infants', '120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight\u2009<\u200910th centile']","['optimized nutrition alone (controls', 'individualized plus optimized nutrition (experimental']","['weight gain, linear growth, or weight/length disproportion', 'velocity of weight gain and linear growth', 'frequency of weight/length disproportion', 'Weight-gain velocity']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",120.0,0.444572,"Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.","[{'ForeName': 'Luc P', 'Initials': 'LP', 'LastName': 'Brion', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA. luc.brion@utsouthwestern.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rosenfeld', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Heyne', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'L Steven', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Cheryl S', 'Initials': 'CS', 'LastName': 'Lair', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Elen', 'Initials': 'E', 'LastName': 'Petrosyan', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Jacob', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caraig', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Patti J', 'Initials': 'PJ', 'LastName': 'Burchfield', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0609-1']
3329,32072150,Long Term Follow-up Data and Health-Related Quality of Life in Frontline Therapy of Fit Patients Treated With FCR Versus BR (CLL10 Trial of the GCLLSG).,"Fludarabine, cyclophosphamide and rituximab (FCR) was compared to bendamustine and rituximab (BR) in an international, randomized, open label, phase 3 trial in 561 previously untreated, fit patients with chronic lymphocytic leukemia (CLL) without del (17p). Primary endpoint was progression free survival (PFS). The final primary endpoint analysis after 37.1 months median follow up failed to show the non-inferiority of BR as compared with FCR. With extended median follow up of 58.2 months, median PFS was 42.3 months in BR-treated patients versus 57.6 months for FCR-treated patients (Hazard Ratio [HR] 1.593; 95% CI 1.271-1.996; p < 0.0001). For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134). Median OS was not reached for both arms with 5-year OS rates of 80.1% vs 80.9%, respectively (HR 1.108; 95% CI 0.755-1.627; p = 0.599). No statistically significant difference was found in the time to secondary malignancy between the 2 groups (at 5 years, 86.6% free from secondary malignancies in the BR group vs 83.8% in the FCR group [HR 0.801; 95% CI 0.507-1.267; p = 0.344]). In patients >65 years secondary neoplasia occurred more frequently after FCR treatment [28 of 86 (32.6%) patients] as compared with BR [18 of 107 (16.8%) patients; p = 0.011]. Health-related quality of life was similar in both treatments. Despite the improved PFS for FCR, OS did not differ. These results also suggest an increase in secondary neoplasia associated with FCR in elderly fit CLL patients.",2020,"For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134).","['Fit Patients', '561 previously untreated, fit patients with chronic lymphocytic leukemia (CLL) without del (17p', 'elderly fit CLL patients']","['bendamustine and rituximab (BR', 'FCR', 'Fludarabine, cyclophosphamide and rituximab (FCR']","['neoplasia', 'median PFS', 'Median OS', 'Health-related quality of life', 'progression free survival (PFS', '5-year OS rates', 'time to secondary malignancy', 'secondary neoplasia']","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",561.0,0.108604,"For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134).","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kutsch', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Maurer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'De Silva', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': 'Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Weide', 'Affiliation': 'Praxis fuer Haematologie und Onkologie, Koblenz, Germany.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kiehl', 'Affiliation': 'Department of Internal Medicine, Frankfurt (Oder) General Hospital, Frankfurt/Oder, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sökler', 'Affiliation': 'Department II of Internal Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': 'Practice for Oncology, Würzburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vehling-Kaiser', 'Affiliation': 'Oncology and Palliative Care, Day clinic Landshut, Landshut, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Köchling', 'Affiliation': 'Private Oncology Practice, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Plöger', 'Affiliation': 'Private Oncology Practice, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gregor', 'Affiliation': 'Division of Hematology, Cantonal Hospital of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Plesner', 'Affiliation': 'Department of Hematology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department of Medicine II, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Hematopathology Section, Christian-Albrechts-University Kiel, Kiel, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department of Medicine II, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}]",HemaSphere,['10.1097/HS9.0000000000000336']
3330,31958518,Transcranial direct current stimulation improves risky decision making in women but not in men: A sham-controlled study.,"Behavioral and anatomical sex-related differences have been traditionally found in decision-making processes assessed by Iowa Gambling Task (IGT). So far, the administration of transcranial direct current stimulation (tDCS) over orbitofrontal regions has shown an enhancing effect over decision-making. However, it is unknown whether there is a sex-dependent effect of stimulation in decision-making, a key question considering previous differences between men and women in IGT and the influence of individual differences in tDCS. The present study examines, at first time, the interaction between sex and tDCS in decision-making. For that aim, in a first experimental phase, ninety-two healthy participants performed the IGT. In a second phase, sixty-one participants received 20 min of anodal or sham tDCS over the right orbitofrontal cortex (rOFC) in a single-session pre-post sham-controlled study. To support the focality of the montage, a Stop Signal Task (SST) was used as a control task and also a numerical simulation of current flow distribution was performed. According to literature, in the first phase, results showed that men outperformed women in the IGT. In the second phase, the stimulation varied the IGT performance according to a sex specific manner: anodal tDCS increased the IGT performance in women, while in men; the stimulation did not produce any effect. Results were mediated by sex-specific morphological differences. These results highlight the necessity to consider the interaction of sex with the effect of the stimulation in future tDCS protocols, specifically in future clinical studies.",2020,Behavioral and anatomical sex-related differences have been traditionally found in decision-making processes assessed by Iowa Gambling Task (IGT).,"['women but not in men', 'ninety-two healthy participants performed the IGT']","['20\u202fmin of anodal or sham tDCS over the right orbitofrontal cortex (rOFC', 'Transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS']","['IGT performance', 'risky decision making']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}]",[],92.0,0.0236149,Behavioral and anatomical sex-related differences have been traditionally found in decision-making processes assessed by Iowa Gambling Task (IGT).,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'León', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sánchez-Kuhn', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fernández-Martín', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Páez-Pérez', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'The City College of the City University of New York, New York, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Research and Development, Soterix Medical, New York, USA; The City College of the City University of New York, New York, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sánchez-Santed', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Flores', 'Affiliation': 'Department of Psychology and Health Research Centre, University of Almeria, Almeria, Spain. Electronic address: pflores@ual.es.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112485']
3331,31916142,Intimate Partner Violence Against Low-Income Women in Mexico City and Associations with Child School Attendance: A Latent Class Analysis Using Cross-sectional Data.,"INTRODUCTION


Few studies have investigated how intimate partner violence (IPV), and patterns of IPV experiences, may impact children's school attendance in low- and middle-income countries.
METHODS


Using baseline data from a sub-sample of 659 women in Mexico City enrolled in a randomized controlled trial who reported having a child under age 18 and in school, multilevel latent class analysis (LCA) was used to classify women based on their reported IPV experiences. Multilevel risk regression analyses examined associations between latent class membership and IPV-related disruptions in children's schooling. Latent classes were identified in a prior study.
RESULTS


Overall, 23.3% of women reported their child's school attendance was disrupted due to IPV. LCA identified four distinct classes of IPV experiences: Low Physical and Sexual Violence (39.1%); Low Physical and High Sexual Violence class (14.8%), High Physical and Low Sexual Violence and Injuries (36.5%); and High Physical and Sexual Violence and Injuries (9.6%). Compared with women in the Low Physical and Sexual Violence class, women in the High Physical and Sexual Violence and Injuries class and women in the High Physical and Low Sexual Violence and Injuries class were at greater risk of IPV disrupting children's school attendance (ARR 3.39, 95% CI 2.34, 4.92; ARR 2.22, 95% CI 1.54, 3.19, respectively). No other statistically significant associations emerged.
DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences. Findings underscore the need to understand underlying mechanisms. Future work integrating both violence against women and violence against children is needed.",2020,"DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences.","[""children's schooling"", 'violence against women and violence against children', 'Using baseline data from a sub-sample of 659 women in Mexico City enrolled in a randomized controlled trial who reported having a child under age 18 and in school, multilevel latent class analysis (LCA) was used to classify women based on their reported IPV experiences', 'Intimate Partner Violence Against Low-Income Women in Mexico City and Associations with Child School Attendance']",['LCA'],"['High Physical and Low Sexual Violence and Injuries', 'High Physical and Sexual Violence and Injuries', 'Low Physical and High Sexual Violence class', 'Physical and Sexual Violence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",659.0,0.0256355,"DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scolese', 'Affiliation': 'Department of Global and Community Health, College of Health and Human Services, George Mason University, Fairfax, VA, USA. ascolese@masonlive.gmu.edu.'}, {'ForeName': 'Tiara C', 'Initials': 'TC', 'LastName': 'Willie', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, New York City, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sipsma', 'Affiliation': 'Benedictine University, Lisle, IL, USA.'}, {'ForeName': 'Paola Abril', 'Initials': 'PA', 'LastName': 'Campos', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Claudia Diaz', 'Initials': 'CD', 'LastName': 'Olavarrieta', 'Affiliation': 'National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Jhumka', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Global and Community Health, College of Health and Human Services, George Mason University, Fairfax, VA, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02877-8']
3332,31912376,Measurement of Parenting Self-efficacy Among Female HIV-Affected Caregivers in Uganda.,"OBJECTIVES


Parenting self-efficacy has been associated with positive parenting behaviors, fewer parental mental health problems, less family dysfunction, and better child development outcomes. The parenting sense of competence (PSOC) scale is commonly used to measure parenting self-efficacy in high-resource settings. This study sought to examine the factor structure, internal consistency, and convergent construct validity of the PSOC in a sample of predominantly HIV-infected women in Uganda.
METHODS


Using data from 155 HIV-affected caregivers who participated in a randomized controlled trial of a parenting intervention, two and three factor models of a 16-item translated version of the PSOC were tested using confirmatory factor analysis. Multivariable regression models were used to examine relationships between parenting confidence (operationalized using the best-fitting PSOC model), caregiver mental health symptoms (depression and anxiety), social support, family dysfunction, and family wealth, after adjusting for covariates.
RESULTS


Neither the two- nor three-factor models of the PSOC demonstrated adequate model fit; however, adequate model fit was demonstrated for a one-factor model that included only items from the PSOC efficacy subscale. Cronbach's alpha was 0.73 for this subscale. Correlates of parenting self-efficacy in this sample included caregiver depression, family dysfunction, and family wealth, but not caregiver anxiety or social support.
CONCLUSIONS FOR PRACTICE


These findings lend support for future use of the PSOC efficacy subscale among HIV-affected caregivers of children in low-resource settings such as rural Uganda.",2020,"Neither the two- nor three-factor models of the PSOC demonstrated adequate model fit; however, adequate model fit was demonstrated for a one-factor model that included only items from the PSOC efficacy subscale.","['sample of predominantly HIV-infected women in Uganda', 'Using data from 155 HIV-affected caregivers who participated', 'Female HIV-Affected Caregivers in Uganda']",['parenting intervention'],"['Parenting Self-efficacy', 'PSOC efficacy subscale', 'parenting sense of competence (PSOC) scale', 'caregiver mental health symptoms (depression and anxiety), social support, family dysfunction, and family wealth']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037438'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",155.0,0.0354395,"Neither the two- nor three-factor models of the PSOC demonstrated adequate model fit; however, adequate model fit was demonstrated for a one-factor model that included only items from the PSOC efficacy subscale.","[{'ForeName': 'Jura L', 'Initials': 'JL', 'LastName': 'Augustinavicius', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Room 780, Baltimore, MD, 21205, USA. Jaugust6@jhu.edu.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Room 863, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Familiar-Lopez', 'Affiliation': 'Department of Psychiatry, Michigan State University, 909 Fee Rd, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Boivin', 'Affiliation': 'Departments of Psychiatry and Neurology & Ophthalmology, The Michigan State University College of Osteopathic Medicine0, 909 Fee Rd., Room 327, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mutebe', 'Affiliation': 'Global Health Uganda, Mawanda Road, Plot 667, P.O. BOX 33842, Kampala, Uganda.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Arima', 'Affiliation': 'Global Health Uganda, Mawanda Road, Plot 667, P.O. BOX 33842, Kampala, Uganda.'}, {'ForeName': 'Judith K', 'Initials': 'JK', 'LastName': 'Bass', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Room 861, Baltimore, MD, 21205, USA.'}]",Maternal and child health journal,['10.1007/s10995-019-02855-9']
3333,32067628,Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger.,"The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height  Z -score (24 months:  P  = 0.11 azithromycin communities,  P  = 0.75 placebo communities), weight-for-age  Z -score (24 months:  P  = 0.83 azithromycin,  P  = 0.78 placebo), height-for-age  Z -score (24 months:  P  = 0.30 azithromycin,  P  = 0.87 placebo), or mid-upper arm circumference (24 months:  P  = 0.12 azithromycin,  P  = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.",2020,Parasitemia was not associated with weight-for-height  Z -score,"['children living in communities participating in a cluster-randomized trial of', 'Preschool Children in Niger']","['placebo', 'biannual azithromycin', 'azithromycin']","['Malaria Parasitemia and Nutritional Status', 'height-for-age  Z', 'weight-for-age  Z -score', 'Parasitemia', 'malaria parasitemia and nutritional status', 'childhood mortality', 'malaria parasitemia', 'score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0869806,Parasitemia was not associated with weight-for-height  Z -score,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Salissou', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': 'For The Mordor Study Group', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0547']
3334,32066559,"Visual and refractive outcomes and complications in femtosecond laser-assisted versus conventional phacoemulsification cataract surgery: findings from a randomised, controlled clinical trial.","BACKGROUND/AIM


To compare visual and refractive outcomes, changes in intraocular pressure (IOP), and complications of femtosecond laser-assisted cataract surgery (FLACS) to conventional phacoemulsification surgery (CPS) in paired eyes from the same patients.
METHODS


This is a secondary analysis of an intraindividual, randomised, controlled clinical trial including 110 paired eyes from 55 patients that were randomised into either FLACS or CPS groups. Outcomes were recorded at baseline and postoperatively during a 3-month follow-up period.
RESULTS


Uncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05). The mean absolute refractive error was not significantly different between the two groups at postoperative month 1 (POM1) (0.3±0.2 D in FLACS vs 0.4±0.3 D in CPS, p=0.18) and month 3 (POM3) (0.3±0.3 D in FLACS vs 0.3±0.3 D in CPS, p=0.71). IOP was statistically higher in the FLACS group on postoperative day 1 (20.6±5.7 mm Hg for FLACS and 18.0±4.9 mm Hg for CPS, p=0.01). However, it was similar between the two groups subsequently (p>0.05). Intraoperatively, one case of posterior capsular block syndrome was observed in the FLACS group. Postoperatively, one case of newly developed glaucoma was observed in the FLACS group and one case of retinal tears in the CPS group.
CONCLUSION


The 3-month postoperative refractive and visual outcomes were comparable between FLACS and CPS in paired eyes from the same patients. Complication rate was low in the study population.",2020,"RESULTS


Uncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05).","['110 paired eyes from 55 patients', 'paired eyes from the same patients']","['FLACS or CPS', 'FLACS', 'femtosecond laser-assisted cataract surgery (FLACS', 'femtosecond laser-assisted versus conventional phacoemulsification cataract surgery', 'conventional phacoemulsification surgery (CPS']","['posterior capsular block syndrome', 'Complication rate', 'Visual and refractive outcomes and complications', 'intraocular pressure (IOP), and complications', 'mean absolute refractive error', 'Uncorrected distance visual acuity and corrected distance visual acuity', 'IOP', '3-month postoperative refractive and visual outcomes']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1535894', 'cui_str': 'Capsular bag distension syndrome'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",110.0,0.26307,"RESULTS


Uncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05).","[{'ForeName': 'Daliya', 'Initials': 'D', 'LastName': 'Dzhaber', 'Affiliation': 'Cornea, Cataract and External Diseases, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Osama M', 'Initials': 'OM', 'LastName': 'Mustafa', 'Affiliation': 'Cornea, Cataract and External Diseases, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Alsaleh', 'Affiliation': 'Ophthalmology Department, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Yassine J', 'Initials': 'YJ', 'LastName': 'Daoud', 'Affiliation': 'Cornea, Cataract and External Diseases, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA ydaoud1@jhmi.edu.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314548']
3335,32067633,Biannual Treatment of Preschool Children with Single Dose Azithromycin to Reduce Mortality: Impact on Azithromycin Resistance in the MORDOR Trial in Tanzania.,"The  Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance  study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1-59 months. From each community, 40 children (aged 1-59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of  Streptococcus pneumoniae  and  Escherichia coli  were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of  S. pneumoniae  and  E. coli  isolation between treatment arms were similar. The proportions of azithromycin-resistant  S. pneumoniae  isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%;  P  = 0.26), 26.8% (16.5%;  P  = 0.29), and 13.4% (17.0%;  P  = 0.57), respectively. The proportions of azithromycin-resistant  E. coli  isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%;  P  = 0.16), 21.5% (16.6%;  P  = 0.10), and 14.9% (14.7%;  P  = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively ( P  = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.",2020,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"['Thirty randomly selected communities in Kilosa district, Tanzania', '40 children (aged 1-59 months', 'Preschool Children with Single Dose']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin versus placebo']","['mean treatment coverage', 'rates of  S. pneumoniae  and  E. coli  isolation', 'Mortality', 'mortality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",30.0,0.109285,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Coles', 'Affiliation': 'Infectious Disease Clinical Research Program, Uniformed University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Mabula', 'Initials': 'M', 'LastName': 'Kasubi', 'Affiliation': 'Department of Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0086']
3336,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3337,31537118,"The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes.","Identification of mental health risk is important for optimising diabetes care in type 2 diabetes mellitus (T2DM). Personality is linked to diabetes health and may assist detection of individuals with T2DM most at risk of chronic mental health difficulties. This study examined the moderator effect of personality factors on changes in psychological distress and functioning in adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period. Data were obtained from participants in a randomised controlled trial of adults with T2DM.  Participants completed measures of depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes) at baseline, 3-, 6- and 12-months. Glycaemic control (HbA1c) was measured at baseline, 6- and 12-months. Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory). Low neuroticism was linked with reduced depression, anxiety, functional impairment and diabetes distress over the year. High extraversion was associated with decreased anxiety and functional impairment. High conscientiousness was linked to increased healthy eating. No personality trait moderated HbA1c levels. Personality screening may help identify mental health risk and guide medical carer approach in T2DM patients.",2020,No personality trait moderated HbA1c levels.,"['Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory', 'adults with T2DM', 'mild-to-moderately depressed adults with type 2 diabetes', 'T2DM patients', 'adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period']",[],"['anxiety and functional impairment', 'depression, anxiety, functional impairment and diabetes distress', 'healthy eating', 'Glycaemic control (HbA1c', 'depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0031213'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",,0.0424957,No personality trait moderated HbA1c levels.,"[{'ForeName': 'Samineh', 'Initials': 'S', 'LastName': 'Sanatkar', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baldwin', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': 'Department of General Practice, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'Department of General Practice, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Wilhelm', 'Affiliation': 'School of Psychiatry, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'Diabetes and Metabolism Division, Garvan Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'School of Medicine, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lapsley', 'Affiliation': 'School of Psychiatry, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1668567']
3338,32046665,Plasma HER2ECD a promising test for patient prognosis and prediction of response in HER2 positive breast cancer: results of a randomized study - SAKK 22/99.,"BACKGROUND


The HER2 extracellular domain shed in blood (HER2 ECD ) is reported to rise and fall in parallel with HER2+ breast cancer behavior. In this study, we evaluated the clinical relevance of plasma HER2 ECD  values in patients with metastatic breast cancer treated in the SAKK22/99 trial comparing trastuzumab monotherapy followed by trastuzumab-chemotherapy combination at progression versus upfront combination therapy.
METHODS


Quantitative assessment of plasma HER2 ECD  was performed in 133 patients at baseline; after 2-24 h; at 3 weeks; at first response evaluation (8-9 weeks); and at tumor progression. Associations with tumor characteristics, disease course and trial treatment were evaluated.
RESULTS


Baseline HER2 ECD  levels were stable within 24 h after the first trastuzumab injection. These plasma values correlated positively with the HER2 gene ratio (r s  = 0.39, P < 0.001) and HER2 protein expression levels (r s  = 0.36, P < 0.001) but not with ER/PR status of the primary tumor. HER2 ECD  baseline levels were positively associated with the presence of visceral disease (P = 0.05) and poor patients' outcome (Cox-regression: P = 0.009). Patients with high baseline levels (> 35 ng/ml) had the worst overall survival (P = 0.03) if treated with upfront combination therapy. Conversely, patients with low HER2 ECD  baseline values (< 15 ng/ml) had longer time to progression on combined trastuzumab-chemotherapy when first treated with trastuzumab monotherapy (P = 0.02). Monitoring HER2 ECD  levels during the course of the trial revealed significant time (P = 0.001) and time-treatment arm interactions (P = 0.0007). Under upfront trastuzumab alone, the HER2 ECD  levels remained stable until just before disease progression. In patients responding to combination treatment HER2 ECD  levels decreased to > 20%.
CONCLUSIONS


Plasma HER2 ECD  levels in patients with metastatic breast cancer reflect HER2 disease status. This robust biomarker might help identifying patients without visceral disease profiting from a sequential treatment's modality. Monitoring HER2 ECD  levels during trastuzumab monotherapy could help defining the optimal time to introduce chemotherapy.
TRIAL REGISTRATION


Registration Number by ClinicalTrials.gov: NCT00004935, Trial number: SAKK22/99. Registered on 27 January 2003.",2020,Patients with high baseline levels (> 35 ng/ml) had the worst overall survival (P = 0.03) if treated with upfront combination therapy.,"['HER2 positive breast cancer', 'patients with metastatic breast cancer reflect HER2 disease status', '133 patients at baseline; after 2-24\u2009h; at 3\u2009weeks; at first response evaluation (8-9\u2009weeks); and at tumor progression', 'patients with metastatic breast cancer treated in the SAKK22/99 trial comparing']","['trastuzumab monotherapy', 'HER2', 'trastuzumab monotherapy followed by trastuzumab-chemotherapy combination at progression versus upfront combination therapy']","['Baseline HER2 ECD  levels', 'HER2 protein expression levels', 'worst overall survival', 'HER2 ECD  levels', 'visceral disease', 'HER2 ECD  baseline levels', 'Monitoring HER2 ECD  levels', 'Plasma HER2 ECD  levels', 'plasma HER2 ECD', 'longer time to progression']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0443102,Patients with high baseline levels (> 35 ng/ml) had the worst overall survival (P = 0.03) if treated with upfront combination therapy.,"[{'ForeName': 'Serenella', 'Initials': 'S', 'LastName': 'Eppenberger-Castori', 'Affiliation': 'University Hospital Basel, Institute of Human Genetic and Pathology, Schönbeinstrasse 40, CH-4031, Basel, Switzerland. sere.eppenberger@unibas.ch.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Klingbiel', 'Affiliation': 'SAKK Swiss Group for Clinical Cancer Research Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Brustzentrum Ostschweiz and University of Basel, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dietrich', 'Affiliation': 'SAKK Swiss Group for Clinical Cancer Research Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Daniel Alexander', 'Initials': 'DA', 'LastName': 'Rufle', 'Affiliation': 'University Hospital Basel, Institute of Human Genetic and Pathology, Schönbeinstrasse 40, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rothgiesser', 'Affiliation': 'SAKK Swiss Group for Clinical Cancer Research Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Pagani', 'Affiliation': 'Breast Unit and Institute of Oncology of Southern Switzerland, Geneva University Hospitals, Swiss Group for Clinical Cancer Research (SAKK), Lugano, Viganello, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'University of Basel, Basel, Switzerland.'}]",BMC cancer,['10.1186/s12885-020-6594-0']
3339,32034285,Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.,"The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.",2020,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","['newly diagnosed myeloma', 'newly diagnosed, transplant-eligible multiple myeloma (MM']","['Response-adapted lenalidomide maintenance', 'CR) lenalidomide (LEN) maintenance therapy (MT', 'induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n\u2009=\u2009502): arms A1:PAd\u2009+\u2009LEN-2Y (n\u2009=\u2009125), B1:PAd\u2009+\u2009LEN-CR (n\u2009=\u2009126), A2:VCD\u2009+\u2009LEN-2Y (n\u2009=\u2009126), B2:VCD\u2009+\u2009LEN-CR']","['PFS', 'overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0511233,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dürig', 'Affiliation': 'Department of Hematology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Bertsch', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Merz', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hügle-Dörr', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Tichy', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giesen', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Huhn', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Elmaagacli', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg St. Georg, Hamburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Rabold', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Goerner', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Internal Medicine V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Medical Clinic A, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0724-1']
3340,32054982,Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial.,"OBJECTIVE


To study the efficacy of intranasal fentanyl as an adjunct for pain management during screening for retinopathy of prematurity (ROP) in preterm infants.
STUDY DESIGN


In this single center, double blinded, randomized controlled trial, preterm neonates between 30 and 34 weeks postmenstrual age received either intranasal fentanyl (2 mcg/kg) or intranasal normal saline through a mucosal atomization device 5 min prior to the first ROP-screening examination. Both the groups received standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment). The primary outcome was premature infant pain profile-revised (PIPP-R) score during the screening.
RESULTS


A total of 111 infants were enrolled. PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001). There was no significant difference in the incidence of adverse effects.
CONCLUSION


Intranasal fentanyl significantly reduced the pain associated with retinal examination without increasing the risk of respiratory depression. Large RCTs are required to verify the efficacy and safety of intranasal fentanyl for acute procedural pain in neonates.
CLINICAL TRIAL REGISTRATION


CTRI/2017/12/011016.",2020,"PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001).","['preterm neonates between 30 and 34 weeks postmenstrual age received either', 'A total of 111 infants were enrolled', 'preterm infants']","['standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment', 'intranasal fentanyl', 'intranasal normal saline through a mucosal atomization device 5\u2009min prior to the first ROP-screening examination', 'Intranasal fentanyl']","['PIPP-R score', 'incidence of adverse effects', 'premature infant pain profile-revised (PIPP-R) score', 'pain', 'risk of respiratory depression']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0072510', 'cui_str': 'proxymetacaine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0031804', 'cui_str': 'Physical Containment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]",111.0,0.588892,"PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001).","[{'ForeName': 'Mythily', 'Initials': 'M', 'LastName': 'Sindhur', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India. drhari@suryahospitals.com.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Srinivasan', 'Affiliation': ""The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Nandkishor S', 'Initials': 'NS', 'LastName': 'Kabra', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Agashe', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Surya Hospital, Mumbai, Maharashtra, India.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0608-2']
3341,32052026,Efficacy and Spatial Extent of Yard-Scale Control of Aedes (Stegomyia) albopictus (Diptera: Culicidae) Using Barrier Sprays and Larval Habitat Management.,"The Asian tiger mosquito, Aedes (Stegomyia) albopictus (Skuse), is a peridomestic, container-ovipositing mosquito commonly found throughout the southeastern United States. In the United States, Ae. albopictus is typically considered a nuisance pest; however, it is capable of transmitting multiple pathogens. Ae. albopictus is an important pest species and the target of numerous mosquito control efforts in the United States. Here, we evaluate the effectiveness and spatial extent of Ae. albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting. Sixteen pairs of adjoining neighbors were randomly assigned to treatment groups with one neighbor receiving a treatment and the other monitored for evidence of a spillover effect of the treatments. Ae. albopictus populations in both yards were monitored for 33 d, with treatments occurring on the eighth day. Barrier sprays, both alone and combined with LHM, resulted in a significant reduction in Ae. albopictus abundance posttreatment. While LHM alone did not result in a significant reduction over the entire posttreatment period, Ae. albopictus populations were observed to be in decline during this period. No treatments were observed to have any reduction in efficacy 25 d posttreatment, with treatments involving LHM having a significantly increased efficacy. Yards neighboring treated yards were also observed to have reduced population sizes posttreatment, but these differences were rarely significant. These results provide insights into the population dynamics of Ae. albopictus following two common treatments and will be useful for integrated pest management plans.",2020,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.",['Sixteen pairs of adjoining neighbors'],"['bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM', 'Yard-Scale Control of Aedes (Stegomyia) albopictus ', 'LHM', 'Barrier Sprays and Larval Habitat Management']",['efficacy'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1553702', 'cui_str': 'Neighbor (person)'}]","[{'cui': 'C0390645', 'cui_str': 'bifenthrin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0871648', 'cui_str': 'Habitat'}, {'cui': 'C0560016', 'cui_str': 'yd3'}, {'cui': 'C0222045'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0261689,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Hawkins', 'Affiliation': 'The Mosquito Authority, LLC, Morrisville, NC.'}, {'ForeName': 'Alun L', 'Initials': 'AL', 'LastName': 'Lloyd', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Reiskind', 'Affiliation': 'Department of Entomology and Plant Pathology, North Carolina State University, Raleigh, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa016']
3342,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3343,31595391,"Efficacy of preemptive analgesia versus postoperative analgesia of celecoxib on postoperative pain, patients' global assessment and hip function recovery in femoroacetabular impingement patients underwent hip arthroscopy surgery.","We aimed to investigate the efficacy of preemptive analgesia of celecoxib on postoperative pain, patients' global assessment (PGA) and hip function recovery compared to postoperative analgesia of celecoxib in femoroacetabular impingement (FAI) patients who underwent hip arthroscopy surgery (HAS). The 100 FAI patients underwent HAS were randomly allocated to preemptive analgesia group (N = 50) or postoperative analgesia group (N = 50) as a 1:1 ratio for 3 months. Pain visual analog scale (VAS) score, PGA score, rescue-use pethidine consumption and Harris hip score were assessed. Compared to postoperative analgesia group, pain VAS score decreased on day 1 (P = 0.036), day 2 (P = 0.046) and day 3 (P = 0.046), while was similar prior to operation (P = 0.587), on day 7 (P = 0.398), at month 1 (P = 0.461) and month 3 (P = 0.805) in preemptive analgesia group. Besides, rescue-use pethidine consumption was decreased in preemptive analgesia group than postoperative analgesia group within 3 days (P = 0.016) and within 7 days (P = 0.033) post-operation. For PGA score, it reduced on day 2 (P = 0.030) and day 3 (P = 0.048), while was similar prior to operation (P = 0.699), on day 1 (P = 0.699), day 7 (P = 0.224), at month 1 (P = 0.640) and month 3 (P = 0.400) in preemptive analgesia group than postoperative analgesia group. For Harris hip score, it was similar prior to operation (P = 0.372), on day 7 (P = 0.366), at month 1 (P = 0.466) and month 3 (P = 0.658) between the two groups. In conclusion, preemptive analgesia of celecoxib decreases short-term postoperative pain and PGA, but without effect on long-term hip function recovery than postoperative analgesia of celecoxib in FAI patients who underwent HAS.",2020,"For Harris hip score, it was similar prior to operation (P = 0.372), on day 7 (P = 0.366), at month 1 (P = 0.466) and month 3 (P = 0.658) between the two groups.","['femoroacetabular impingement (FAI) patients who underwent hip arthroscopy surgery (HAS', '100 FAI patients underwent HAS', 'femoroacetabular impingement patients underwent hip arthroscopy surgery', 'FAI patients who underwent HAS']","['celecoxib', 'preemptive analgesia', 'preemptive analgesia group (N\u2009=\u200950) or postoperative analgesia']","['pain VAS score', 'Pain visual analog scale (VAS) score, PGA score, rescue-use pethidine consumption and Harris hip score', ""postoperative pain, patients' global assessment and hip function recovery"", 'rescue-use pethidine consumption', ""postoperative pain, patients' global assessment (PGA) and hip function recovery""]","[{'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",,0.0256744,"For Harris hip score, it was similar prior to operation (P = 0.372), on day 7 (P = 0.366), at month 1 (P = 0.466) and month 3 (P = 0.658) between the two groups.","[{'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, 17 Yongwaizheng Street, Nanchang, 330006, China. pinjiao95685347@163.com.'}]",Inflammopharmacology,['10.1007/s10787-019-00648-8']
3344,31928489,Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study.,"Purpose:  Among cancer survivors, physical activity (PA) is associated with reductions in cancer recurrence, morbidity, and mortality. Most young adult (YA) survivors do not attain adequate PA. Digital modalities, specifically wearable activity monitors with a paired mobile application and private social media group for support offer a promising approach for promoting PA among YAs. We conducted a pilot randomized controlled trial of this intervention. To evaluate its acceptability and perceptions of the intervention components, we conducted qualitative interviews with those in the intervention. The results of our interviews serve to refine future interventions to better serve this population.  Methods:  Semistructured qualitative interviews with 13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor. Analyses included a qualitative thematic analysis of the interview transcripts and coded interview segments into three predetermined categories: facilitators, limitations, and suggestions.  Results:  Participants described wide-ranging benefits of the intervention, citing the Fitbit device and buddy system as major motivators to engage in PA and reach goals. Most participants noted feelings of increased physical and emotional wellness. The most-cited limitation of the intervention was the automated text messages, which participants found impersonal. Suggestions for improvement included integrating more elements of competition and group challenges.  Conclusion:  This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life. Clinicaltrial.gov identifier number: NCT03233581; Date of registration: July 28, 2017.",2020,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"['13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor', 'Young Adult Cancer Survivors', 'Clinicaltrial.gov identifier number', 'Most young adult ']","['Fitbit and Facebook Intervention', 'digital PA intervention']","['cancer recurrence, morbidity, and mortality', 'feelings of increased physical and emotional wellness']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0607168,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"[{'ForeName': 'Evelina M', 'Initials': 'EM', 'LastName': 'Miropolsky', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Scott Baker', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ceballos', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2019.0072']
3345,32057490,Efficacy of BPPV diagnosis and treatment system for benign paroxysmal positional vertigo.,"OBJECTIVES


To evaluate the efficacy of automatic benign paroxysmal positional vertigo (BPPV) diagnosis and treatment system for BPPV compared with the manual repositioning group.
METHODS


Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included. Among them, 150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu) were randomly treated with BPPV diagnosis and treatment system(the experimental group) or manual repositioning (the control group). Resolution of vertigo and nystagmus on the Dix-Hallpike and Roll test on day 3,day 7,day 14 and day 28 follow-up after first treatment was the main outcome measure to assess the efficacy of treatment.
RESULTS


At 3-day and 7-day follow-up after treatment with BPPV diagnosis and treatment system, 79%, 91%had complete resolution of vertigo and nystagmus, the effective rate in the experimental group were significantly higher than those in the control group, the differences were statistically significant(P < .05). On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups. And at 28-day after the first treatment, the effective rate was 100% in the experimental group and the control group. The repositioning efficiency of pc-BPPV (the first, second, third treatment), hc-BPPV (the first, second, third treatment), hc-BPPV-cu(the first, second treatment) in the experimental group were higher than the control group, and the secondary reposition of pc-BPPV in the experimental group was significantly higher than the control group(96%vs.84%; P < .05). While for the hc-BPPV-cu patients, the effective rate of the third treatment in the experimental group was slightly lower than that of the control group, but the differences were not statistically significant.
CONCLUSIONS


BPPV diagnosis and treatment system is effective for the treatment of BPPV, with a better effective rate than those treated with manual maneuver, and is safe and easy to perform on patients.",2020,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","['150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu', 'Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included', 'benign paroxysmal positional vertigo']","['BPPV diagnosis', 'BPPV diagnosis and treatment system(the experimental group) or manual repositioning']","['effective rate', 'vertigo and nystagmus, the effective rate', 'Resolution of vertigo and nystagmus', 'repositioning efficiency of pc-BPPV', 'secondary reposition of pc-BPPV']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1288300', 'cui_str': 'Structure of posterior semicircular canal'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0930838', 'cui_str': 'Structure of lateral semicircular canal'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",230.0,0.0199149,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liangguo', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China. Electronic address: liuxiaoli0907@126.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102412']
3346,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3347,31735246,Examining Positive and Negative Affect as Outcomes and Moderators of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy for Social Anxiety Disorder.,"Traditional cognitive-behavioral therapy (CBT) for anxiety disorders has been designed to target reductions in negative affect (NA) associated with defense-related processes. However, a subset of anxiety disorders, including social anxiety disorder (SAD), are also characterized by low positive affect (PA) resulting from separate deficits in appetitive-related processes. In contrast to CBT, ""third-wave"" approaches, such as acceptance and commitment therapy (ACT), align more consistently with motivational processes and, as a result, PA. However, the differential effect of CBT and ACT on PA and NA has yet to be investigated. Using secondary data from a randomized controlled trial, the present study sought to compare CBT's (n = 45) and ACT's (n = 35) effect on PA and NA in SAD. Findings were compared to a wait-list (WL) control condition (n = 31), as well as normative data from a general adult sample. Baseline PA and NA were also examined as moderators and predictors of theory-relevant treatment outcomes. NA decreased significantly in both CBT and ACT from pre to posttreatment. Although ACT outperformed WL in reducing NA, this effect was not observed for CBT. PA increased significantly in both CBT and ACT from pre to posttreatment, with neither ACT nor CBT outperforming WL in increasing PA. Neither PA nor NA were found to moderate theoretically relevant treatment outcomes. Findings suggest that ACT and CBT share common treatment mechanisms, making them more similar than distinct. Further efforts should be focused on optimizing CBT's and ACT's influence on threat and reward learning, and elucidating common processes of change.",2019,"Although ACT outperformed WL in reducing NA, this effect was not observed for CBT. PA increased significantly in both CBT and ACT from pre to posttreatment, with neither ACT nor CBT outperforming WL in increasing PA.",['Social Anxiety Disorder'],"['ACT and CBT', 'Traditional cognitive-behavioral therapy (CBT']","['social anxiety disorder (SAD', 'CBT. PA']","[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]",,0.0196793,"Although ACT outperformed WL in reducing NA, this effect was not observed for CBT. PA increased significantly in both CBT and ACT from pre to posttreatment, with neither ACT nor CBT outperforming WL in increasing PA.","[{'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Sewart', 'Affiliation': 'University of California, Los Angeles. Electronic address: amysewart@ucla.edu.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Niles', 'Affiliation': 'San Francisco VA Medical Center.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Burklund', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Darby E', 'Initials': 'DE', 'LastName': 'Saxbe', 'Affiliation': 'University of Southern California.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Lieberman', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'University of California, Los Angeles.'}]",Behavior therapy,['10.1016/j.beth.2019.07.001']
3348,32057442,"A prospective, double-blind, randomized, placebo-controlled trial comparing the efficacy of polyethylene glycol versus polyethylene glycol combined with topical diltiazem for treating anal fissure in children.","BACKGROUND


Anal fissure (AF) in children is usually treated with laxatives and/or topical agents such as calcium channel blockers. We hypothesize that owing to the superior efficacy of Polyethylene glycol (PEG) in treating constipation in children, adding diltiazem (DTZ) might not improve healing of AF.
METHODS


Children ≤14 years with anal fissure presented to the pediatric surgery clinic between November 2014 and March 2016 were recruited. Randomization was performed to either PEG with DTZ or PEG with placebo. Study personnel, patients, and their families were blinded. Primary outcome was resolution of symptoms. Secondary outcomes were constipation and treatment complications at 12-week follow up.
RESULTS


48 patients were randomized: 24 to PEG + DTZ and 24 to PEG + placebo. Both groups were similar in their baseline characteristics. At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively. Additionally, there was similar improvement in constipation in both groups.
CONCLUSION


PEG alone was associated with similar improvement in anal fissure symptoms in children compared to PEG and topical diltiazem combined.
LEVEL OF EVIDENCE


I.",2020,"At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively.","['Children ≤14\u202fyears with anal fissure presented to the pediatric surgery clinic between November 2014 and March 2016 were recruited', '48 patients were randomized: 24 to', 'children']","['polyethylene glycol versus polyethylene glycol combined with topical diltiazem', 'placebo', 'PEG + DTZ', 'Polyethylene glycol (PEG', 'PEG + placebo', 'PEG with DTZ or PEG with placebo', 'diltiazem (DTZ']","['resolution of symptoms', 'constipation', 'blood per rectum', 'constipation and treatment complications', 'healing of AF', 'painful defecation', 'anal fissure symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3839137', 'cui_str': 'Pediatric surgery clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0237326', 'cui_str': 'Dyschezia'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}]",48.0,0.395956,"At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively.","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alshehri', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia. Electronic address: Abalshehri@ksu.edu.sa.'}, {'ForeName': 'Rakan', 'Initials': 'R', 'LastName': 'Barghouthi', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Albanyan', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alayed', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Alsubaie', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Rawan', 'Initials': 'R', 'LastName': 'Alhayyan', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alzahem', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Altokhais', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Albassam', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Aljazaeri', 'Affiliation': 'Pediatric Surgery Division, Department of Surgery, King Saud University Medical City, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.01.010']
3349,32028998,Angiotensin I and angiotensin II concentrations and their ratio in catecholamine-resistant vasodilatory shock.,"BACKGROUND


In patients with vasodilatory shock, plasma concentrations of angiotensin I (ANG I) and II (ANG II) and their ratio may reflect differences in the response to severe vasodilation, provide novel insights into its biology, and predict clinical outcomes. The objective of these protocol prespecified and subsequent post hoc analyses was to assess the epidemiology and outcome associations of plasma ANG I and ANG II levels and their ratio in patients with catecholamine-resistant vasodilatory shock (CRVS) enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) study.
METHODS


We measured ANG I and ANG II levels at baseline, calculated their ratio, and compared these results to values from healthy volunteers (controls). We dichotomized patients according to the median ANG I/II ratio (1.63) and compared demographics, clinical characteristics, and clinical outcomes. We constructed a Cox proportional hazards model to test the independent association of ANG I, ANG II, and their ratio with clinical outcomes.
RESULTS


Median baseline ANG I level (253 pg/mL [interquartile range (IQR) 72.30-676.00 pg/mL] vs 42 pg/mL [IQR 30.46-87.34 pg/mL] in controls; P <  0.0001) and median ANG I/II ratio (1.63 [IQR 0.98-5.25] vs 0.4 [IQR 0.28-0.64] in controls; P <  0.0001) were elevated, whereas median ANG II levels were similar (84 pg/mL [IQR 23.85-299.50 pg/mL] vs 97 pg/mL [IQR 35.27-181.01 pg/mL] in controls; P = 0.9895). At baseline, patients with a ratio above the median (≥1.63) had higher ANG I levels (P <  0.0001), lower ANG II levels (P <  0.0001), higher albumin concentrations (P = 0.007), and greater incidence of recent (within 1 week) exposure to angiotensin-converting enzyme inhibitors (P <  0.00001), and they received a higher norepinephrine-equivalent dose (P = 0.003). In the placebo group, a baseline ANG I/II ratio <1.63 was associated with improved survival (hazard ratio 0.56; 95% confidence interval 0.36-0.88; P = 0.01) on unadjusted analyses.
CONCLUSIONS


Patients with CRVS have elevated ANG I levels and ANG I/II ratios compared with healthy controls. In such patients, a high ANG I/II ratio is associated with greater norepinephrine requirements and is an independent predictor of mortality, thus providing a biological rationale for interventions aimed at its correction.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02338843. Registered 14 January 2015.",2020,"At baseline, patients with a ratio above the median (≥1.63) had higher ANG I levels (P <  0.0001), lower ANG II levels (P <  0.0001), higher albumin concentrations (P = 0.007), and greater incidence of recent (within 1 week) exposure to angiotensin-converting enzyme inhibitors (P <  0.00001), and they received a higher norepinephrine-equivalent dose (P = 0.003).","['patients with vasodilatory shock, plasma concentrations of angiotensin', 'healthy volunteers (controls', 'patients with catecholamine-resistant vasodilatory shock (CRVS) enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) study']","['ANG', 'placebo']","['plasma ANG I and ANG II levels and their ratio', 'ANG I and ANG II levels', 'improved survival', 'median ANG II levels', 'Angiotensin I and angiotensin II concentrations', 'higher albumin concentrations', 'lower ANG II levels', 'higher ANG I levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.349701,"At baseline, patients with a ratio above the median (≥1.63) had higher ANG I levels (P <  0.0001), lower ANG II levels (P <  0.0001), higher albumin concentrations (P = 0.007), and greater incidence of recent (within 1 week) exposure to angiotensin-converting enzyme inhibitors (P <  0.00001), and they received a higher norepinephrine-equivalent dose (P = 0.003).","[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Australia. rinaldo.bellomo@austin.org.au.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Division, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Szerlip', 'Affiliation': 'Department of Medicine, Division of Nephrology, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Shane W', 'Initials': 'SW', 'LastName': 'English', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine and Radiology, Royal Melbourne Hospital, The University of Melbourne, Melbourne Medical School, Parkville, Australia.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Damian R', 'Initials': 'DR', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, CA, USA.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, CA, USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}]","Critical care (London, England)",['10.1186/s13054-020-2733-x']
3350,32028984,Machine learning algorithm to predict mortality in patients undergoing continuous renal replacement therapy.,"BACKGROUND


Previous scoring models such as the Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) and the Sequential Organ Failure Assessment (SOFA) scoring systems do not adequately predict mortality of patients undergoing continuous renal replacement therapy (CRRT) for severe acute kidney injury. Accordingly, the present study applies machine learning algorithms to improve prediction accuracy for this patient subset.
METHODS


We randomly divided a total of 1571 adult patients who started CRRT for acute kidney injury into training (70%, n = 1094) and test (30%, n = 477) sets. The primary output consisted of the probability of mortality during admission to the intensive care unit (ICU) or hospital. We compared the area under the receiver operating characteristic curves (AUCs) of several machine learning algorithms with that of the APACHE II, SOFA, and the new abbreviated mortality scoring system for acute kidney injury with CRRT (MOSAIC model) results.
RESULTS


For the ICU mortality, the random forest model showed the highest AUC (0.784 [0.744-0.825]), and the artificial neural network and extreme gradient boost models demonstrated the next best results (0.776 [0.735-0.818]). The AUC of the random forest model was higher than 0.611 (0.583-0.640), 0.677 (0.651-0.703), and 0.722 (0.677-0.767), as achieved by APACHE II, SOFA, and MOSAIC, respectively. The machine learning models also predicted in-hospital mortality better than APACHE II, SOFA, and MOSAIC.
CONCLUSION


Machine learning algorithms increase the accuracy of mortality prediction for patients undergoing CRRT for acute kidney injury compared with previous scoring models.",2020,scoring systems do not adequately predict mortality of patients undergoing continuous renal replacement therapy (CRRT) for severe acute kidney injury.,"['patients undergoing continuous renal replacement therapy', 'patients undergoing CRRT for acute kidney injury', 'patients undergoing', 'severe acute kidney injury', '1571 adult patients who started CRRT for acute kidney injury into training (70%, n\u2009=\u20091094) and test (30%, n\u2009=\u2009477) sets']","['Sequential Organ Failure Assessment (SOFA', 'Machine learning algorithm', 'continuous renal replacement therapy (CRRT', 'Machine learning algorithms']","['accuracy of mortality prediction', 'probability of mortality during admission to the intensive care unit (ICU) or hospital']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002045'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0585045', 'cui_str': 'During admission (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",1571.0,0.0266226,scoring systems do not adequately predict mortality of patients undergoing continuous renal replacement therapy (CRRT) for severe acute kidney injury.,"[{'ForeName': 'Min Woo', 'Initials': 'MW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.'}, {'ForeName': 'Jayoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Dong Ki', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.'}, {'ForeName': 'Kook-Hwan', 'Initials': 'KH', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.'}, {'ForeName': 'Kwon Wook', 'Initials': 'KW', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.'}, {'ForeName': 'Yon Su', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea.'}, {'ForeName': 'Seung Seok', 'Initials': 'SS', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea. hansway80@gmail.com.'}]","Critical care (London, England)",['10.1186/s13054-020-2752-7']
3351,32031879,Dietary Modification and Breast Cancer Mortality: Long-Term Follow-Up of the Women's Health Initiative Randomized Trial.,"PURPOSE


Observational studies of dietary fat intake and breast cancer have reported inconsistent findings. This topic was addressed in additional analyses of the Women's Health Initiative (WHI) Dietary Modification (DM) clinical trial that evaluated a low-fat dietary pattern influence on breast cancer incidence.
METHODS


In the WHI DM trial, 48,835 postmenopausal women, ages 50-79 years, with no prior breast cancer, and a dietary fat intake of ≥ 32% of energy were randomly assigned at 40 US centers to a usual diet comparison group (60%) or dietary intervention group (40%). The goals were to reduce fat intake to 20% of energy and increase vegetable, fruit, and grain intake. Breast cancers were confirmed after central medical record review and serial National Death Index linkages to enhance mortality findings.
RESULTS


During 8.5 years of dietary intervention, breast cancer incidence and deaths as a result of breast cancer were nonsignificantly lower in the intervention group, while deaths after breast cancer were statistically significantly lower both during intervention and through a 16.1-year (median) follow-up. Now, after a long-term, cumulative 19.6-year (median) follow-up, the significant reduction in deaths after breast cancer persists (359 [0.12%]  v  652 [0.14%] deaths; hazard ratio [HR], 0.85; 95% CI, 0.74 to 0.96;  P  = .01), and a statistically significant reduction in deaths as a result of breast cancer (breast cancer followed by death attributed to the breast cancer) emerged (132 [0.037%, annualized risk]  v  251 [0.047%] deaths, respectively; HR, 0.79; 95% CI, 0.64 to 0.97;  P  = .02).
CONCLUSION


Adoption of a low-fat dietary pattern associated with increased vegetable, fruit, and grain intake, demonstrably achievable by many, may reduce the risk of death as a result of breast cancer in postmenopausal women.",2020,"During 8.5 years of dietary intervention, breast cancer incidence and deaths as a result of breast cancer were nonsignificantly lower in the intervention group, while deaths after breast cancer were statistically significantly lower both during intervention and through a 16.1-year (median) follow-up.","['postmenopausal women', '48,835 postmenopausal women, ages 50-79 years, with no prior breast cancer, and a dietary fat intake of ≥ 32% of energy']",['usual diet comparison group (60%) or dietary intervention'],"['breast cancer incidence and deaths as a result of breast cancer', 'deaths', 'fat intake to 20% of energy and increase vegetable, fruit, and grain intake', 'breast cancer', 'vegetable, fruit, and grain intake', 'Dietary Modification and Breast Cancer Mortality']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0425440', 'cui_str': 'Dietary fat intake (observable entity)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",48835.0,0.0288834,"During 8.5 years of dietary intervention, breast cancer incidence and deaths as a result of breast cancer were nonsignificantly lower in the intervention group, while deaths after breast cancer were statistically significantly lower both during intervention and through a 16.1-year (median) follow-up.","[{'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Pan', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mossavar-Rahmani', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Dorothy S', 'Initials': 'DS', 'LastName': 'Lane', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook University School of Medicine, Stony Brook, NY.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Medicine, University of Tennessee, Memphis, TN.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, University at Buffalo, Buffalo, NY.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohan', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Juhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University, Bloomington, IN.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barac', 'Affiliation': 'MedStar Heart and Vascular Institute, Georgetown University, Washington, DC.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00435']
3352,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3353,31631361,"Randomized, Controlled Early Intervention of Dynamic Mode Fractional Ablative CO 2  Laser on Acute Burn Injuries for Prevention of Pathological Scarring.","BACKGROUND AND OBJECTIVES


This study challenges the currently accepted treatment parameters of waiting 1 year following burn injury to treat the resultant scarring. It assesses the impact of treating burn and trauma wounds at less than 3 months of injury on scar formation, providing a new temporal paradigm to patients in the prevention and minimization of scar formation.
STUDY DESIGN/MATERIALS AND METHODS


This randomized clinical trial included 19 patients with moderate-to-severe acute burn injuries less than 3 months from injury. The treatment areas underwent three fractional ablative CO 2  laser treatments at 8-week intervals. The primary outcomes were improvement in the Manchester Scar Scale (MSS) and photography. Secondary outcomes were optical coherence tomography (OCT), treatment time, immediate post-treatment response, and histology.
RESULTS


Upon blinded evaluation, 100% of treatment areas were correctly identified when compared with control. MSS scores before and after treatment were totaled with an averaged sum of 13.33 per scar at baseline to 8.39 after treatment, a 63% average improvement versus control (P < 0.001). Histology and OCT demonstrated a re-organization of the underlying skin structure. The average treatment time was 18 minutes. Immediate post-treatment responses were limited to mild-to-moderate erythema.
CONCLUSIONS


Early intervention with ablative fractional laser on acute traumatic wounds resulted in significant decrease of scar formation compared with untreated areas on the same wounds, providing an impactful new time course to treat severe burn and trauma injuries. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"Early intervention with ablative fractional laser on acute traumatic wounds resulted in significant decrease of scar formation compared with untreated areas on the same wounds, providing an impactful new time course to treat severe burn and trauma injuries.","['19 patients with moderate-to-severe acute burn injuries less than 3 months from injury', '2019']","['Dynamic Mode Fractional Ablative CO 2  Laser', 'ablative fractional laser']","['optical coherence tomography (OCT), treatment time, immediate post-treatment response, and histology', 'MSS scores', 'Manchester Scar Scale (MSS) and photography', 'scar formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.0513382,"Early intervention with ablative fractional laser on acute traumatic wounds resulted in significant decrease of scar formation compared with untreated areas on the same wounds, providing an impactful new time course to treat severe burn and trauma injuries.","[{'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Waibel', 'Affiliation': 'Department of Research, Miami Dermatology and Laser Institute, Miami, Florida.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Gianatasio', 'Affiliation': 'Department of Research, Miami Dermatology and Laser Institute, Miami, Florida.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rudnick', 'Affiliation': 'Department of Research, Miami Dermatology and Laser Institute, Miami, Florida.'}]",Lasers in surgery and medicine,['10.1002/lsm.23170']
3354,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


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


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


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


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3355,32005104,"The effects of promoting oral intake using the Kuchi-kara Taberu index, a comprehensive feeding assistant tool, in older pneumonia patients: a cluster randomized controlled trial.","BACKGROUND


The multidisciplinary comprehensive care (MDCC) program promotes the improvement of oral intake for older patients. The Kuchi-kara Taberu (ingesting orally in Japanese, KT) index was developed to objectively assess patient conditions in the MDCC program. This trial examined the effects of the index in promoting oral intake in older patients with pneumonia.
METHODS


A cluster randomized controlled trial was conducted in 10 local hospitals targeting older patients with pneumonia (≥65 years). Ten hospitals were allocated randomly to either the intervention or the control group. Both groups (each with five hospitals) received the MDCC program for oral feeding, which consisted of professional assessment, care, and treatment. The KT index was used by the intervention group, focusing on improving low score items. The primary outcome was determined using the Functional Oral Intake Scale (FOIS) at discharge or 1 month after admission.
RESULTS


One hundred and twelve patients (46 women and 66 men) who participated from 10 hospitals, with a median age of 88 years (interquartile range [IQR], 80-91), were examined. The median FOIS level and the number of patients with oral intake (FOIS ≥ level 4) at discharge were 4 (IQR, 4-6) and 89 (79.5%), respectively. The duration of nil per os was 2 (IQR, 1-5) days. Clusters were not matched in the presence of Kuchi-kara Taberu Shiawase-wo Mamoru-kai-certified medical staff promoting oral intake in patients with dysphagia in each hospital. The median FOIS levels of 53 patients in the intervention group and 59 patients in the control group were 5 (IQR, 4-6) and 4 (IQR, 4-5), respectively, showing no statistically significant difference (P = 0.76). According to a multivariate analysis, the KT index had no positive effect on FOIS levels.
CONCLUSIONS


This trial was not able to demonstrate the usefulness of the KT index due to random assignment failure. However, both the intervention and control groups showed a high prevalence of oral intake (FOIS ≥ level 4) at discharge.
TRIAL REGISTRATION


UMIN-Clinical Trial Registry, UMIN000025172, December 17, 2016.",2020,"According to a multivariate analysis, the KT index had no positive effect on FOIS levels.
","['10 local hospitals targeting older patients with pneumonia (≥65\u2009years', 'patients with dysphagia in each hospital', 'older pneumonia patients', 'Ten hospitals', 'older patients with pneumonia', 'One hundred and twelve patients (46 women and 66 men) who participated from 10 hospitals, with a median age of 88\u2009years (interquartile range [IQR], 80-91', 'older patients']",['MDCC program'],"['median FOIS level', 'duration of nil per os', 'Functional Oral Intake Scale (FOIS) at discharge or 1\u2009month after admission', 'FOIS levels', 'median FOIS levels', 'oral intake']","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0419179', 'cui_str': 'Nil per os'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0222045'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",10.0,0.0921302,"According to a multivariate analysis, the KT index had no positive effect on FOIS levels.
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Shamoto', 'Affiliation': 'Department of Geriatric Internal Medicine, Takano Hospital, 214 Higashi-machi, shimokitaba, Hirono-machi, Futaba-County, Fukushima, 960-0402, Japan. shahonvs17@gmail.com.'}, {'ForeName': 'Tamami', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Chairman, Kuchi-kara Taberu Shiawase-wo Mamoru-kai (KTSM, an incorporated nonprofit organization), 509, 722-1,Ishida, Isehara City, Kanagawa, 259-1116, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Momosaki', 'Affiliation': 'Department of Rehabilitation Medicine, Teikyo University School of Medicine University Hospital, Mizonokuchi, 5-1-1 Futako, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Palliative and Supportive Medicine, Graduate School of Medicine, Aichi Medical University, 1-1, Yazakokarimata, Nagakute City, Aichi, 480-1195, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Rehabilitation Medicine, Yokohama City University Medical Center, 4-57 Urafune-chou, Minami ward, Yokohama City, Kanagawa, 232-0024, Japan.'}]",BMC geriatrics,['10.1186/s12877-020-1447-x']
3356,31984508,"Growth factor concentrations in platelet-rich plasma for androgenetic alopecia: An intra-subject, randomized, blinded, placebo-controlled, pilot study.","BACKGROUND


Platelet-rich plasma (PRP), processed from autologous peripheral blood, is used to treat androgenetic alopecia (AGA).
OBJECTIVE


To determine the efficacy of PRP for hair growth promotion in AGA patients in a randomized, blinded, placebo-controlled, pilot clinical trial (NCT02074943).
METHODS


The efficacy of an 8 week, five session, PRP treatment course was determined by measuring hair density and hair caliber changes in 10 AGA affected patients. For each PRP sample, the concentrations of selected growth factors were determined using a multiplex assay system. The clinical results were then correlated with the growth factor concentrations in PRP.
RESULTS


At 16 weeks, 8 weeks after the last PRP injection, treated areas exhibited increased mean hair density (+12.76%) over baseline compared to placebo (+0.99%). Mean hair caliber decreased in both treated and placebo regions (-16.22% and -19.46%, respectively). Serial analysis of PRP significant variability in concentrations between patients. Overall, there was a positive correlation between GDNF concentration and hair density (P = .004). Trends, though not statistically significant, were also observed for FGF2 and VEGF.
LIMITATIONS


Small sample size and lack of comparative cohorts receiving protocol variations limit confidence in the study data.
CONCLUSIONS


This small pilot clinical trial suggests PRP treatment may be beneficial for AGA. However, the variable hair growth responses between patients indicate there is a significant opportunity to improve PRP therapy protocols for hair growth promotion. The variability in growth factor concentration in PRP suggests standardization of growth factors postprocessing might improve hair growth responses.",2020,Mean hair caliber decreased in both treated and placebo regions (-16.22% and -19.46% respectively).,"['AGA patients', 'androgenetic alopecia']","['placebo', 'PRP']","['FGF2 and VEGF', 'mean hair density', 'Mean hair caliber', 'hair density and hair caliber changes', 'GDNF concentration and hair density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell Line-Derived Neurotrophic Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.109716,Mean hair caliber decreased in both treated and placebo regions (-16.22% and -19.46% respectively).,"[{'ForeName': 'Tee Wei', 'Initials': 'TW', 'LastName': 'Siah', 'Affiliation': 'Watford General Hospital, Watford, Hertfordshire, UK.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Department of Dermatology, Wayne State University School of Medicine, Dearborn, MI, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Santos', 'Affiliation': 'Department of Medicine, Santa Casa of São Paulo School of Medicine, São Paulo, SP, Brazil.'}, {'ForeName': 'Hisae', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Gigi', 'Initials': 'G', 'LastName': 'Leung', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'McElwee', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.'}]",Experimental dermatology,['10.1111/exd.14074']
3357,30981681,Dietary-fat effect of the rs10830963 polymorphism in MTNR1B on insulin resistance in response to 3 months weight-loss diets.,"BACKGROUND & AIMS


The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with obesity. We study the effect of this SNP on cardiovascular risk factors and weight loss secondary to 2hypocaloric diets.
METHODS


361 obese subjects were randomly allocated during 3 months (Diet M - high monounsaturated fat hypocaloric diet vs. Diet P - high polyunsaturated fat hypocaloric diet). Anthropometric parameters, fasting blood glucose, C-reactive protein (CRP), insulin concentration, insulin resistance (HOMA-IR), lipid profile and adipocytokines levels were measured. Genotype of MTNR1B gene polymorphism (rs10830963) was evaluated.
RESULTS


All anthropometric parameters, systolic blood pressure and leptin levels decreased in all subjects after both diets. This improvement of anthropometric parameters was higher in non G allele carriers than G allele carriers. After dietary intervention with Diet M, (CC vs. CG + GG); total cholesterol (delta: -10.4 ± 2.1mg/dl vs. -6.4 ± 1.2mg/dl: P <.05), LDL-cholesterol (delta:-7.1 ± 0.9mg/dl vs. -2.8 ± 0.8mg/dl: P <.05), insulin (delta:-3.0 ± 0.8 UI/L vs. -2.0 ± 1.0 UI/L: P<.05) and HOMA-IR (delta:-3.4 ± 1.0 units vs. -2.9 ± 0.9 units: P<.05) improved in no G allele carriers. After Diet P, in the group of subjects without G allele CC, insulin levels (delta: -2.9 ± 1.0 UI/L vs. -0.6 ± 0.2 UI/L: P <.05) and HOMA-IR (delta (CC vs. CG + GG): -0.8 ± 0.2 units vs. -0.4 ± 0.3 units: P <.05) decreased, too.
CONCLUSIONS


Our study detected a relationship of rs10830963 MTNR1B SNP with body weight loss and insulin resistance modification induced by 2different hypocaloric. Only monounsaturated enriched hypocaloric diet and in no-G allele carriers showed a significant effect on lipoproteins.",2020,The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with obesity.,['361 obese subjects'],"['Diet M - high monounsaturated fat hypocaloric diet vs. Diet P - high polyunsaturated fat hypocaloric diet', 'SNP']","['insulin levels', 'anthropometric parameters', 'LDL-cholesterol', 'lipoproteins', 'HOMA-IR (delta (CC vs. CG + GG', 'Anthropometric parameters, fasting blood glucose, C-reactive protein (CRP), insulin concentration, insulin resistance (HOMA-IR), lipid profile and adipocytokines levels', 'All anthropometric parameters, systolic blood pressure and leptin levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",361.0,0.02028,The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with obesity.,"[{'ForeName': 'Daniel Antonio', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Centro de Investigacion de Endocrinología y Nutrición Clínica, Facultad de Medicina, Valladolid, España; Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Universidad de Valladolid, Valladolid, España. Electronic address: dadluis@yahoo.es.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Centro de Investigacion de Endocrinología y Nutrición Clínica, Facultad de Medicina, Valladolid, España; Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Universidad de Valladolid, Valladolid, España.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Centro de Investigacion de Endocrinología y Nutrición Clínica, Facultad de Medicina, Valladolid, España; Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Universidad de Valladolid, Valladolid, España.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Centro de Investigacion de Endocrinología y Nutrición Clínica, Facultad de Medicina, Valladolid, España; Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Universidad de Valladolid, Valladolid, España.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.02.007']
3358,31812999,Trauma- and Stress-Induced Craving for Alcohol in Individuals Without PTSD.,"AIMS


The main objective of the study was to compare the differences in craving following trauma and stress scripts in individuals with alcohol dependence (AD) who have experienced trauma but did not meet criteria for post-traumatic stress disorder (PTSD).
METHODS


Twenty-eight men and women who participated in a treatment trial were included in this study before starting treatment. All had to meet criteria for AD and had experienced trauma at some point of their lives but were never diagnosed with PTSD. All participants had one laboratory session and were exposed to stress, trauma and neutral scripts randomly assigned. Main measures of craving, anxiety and mood were administered before, during and after each script.
RESULTS


Stress and trauma scripts induced significantly more craving and anxiety than the neutral scripts. Interestingly, stress scripts produced stronger craving and anxiety than the trauma scripts but only with some measures. Stress and trauma scripts produced significantly more fear, anger and sadness and significantly lower ratings of joy and relaxation than the neutral script. Again, there were no differences between stress and trauma scripts for any of the emotional subscales.
CONCLUSIONS


Trauma scripts did not result in stronger craving than stress scripts. These findings suggest that trauma in the absence of PTSD diagnosis does not lead to stronger craving for alcohol.",2020,"Stress and trauma scripts produced significantly more fear, anger and sadness and significantly lower ratings of joy and relaxation than the neutral script.","['All participants had one laboratory session and were exposed to stress, trauma and neutral scripts randomly assigned', 'individuals with alcohol dependence (AD) who have experienced trauma but did not meet criteria for post-traumatic stress disorder (PTSD', 'Twenty-eight men and women who participated in a treatment trial', 'Individuals Without PTSD']",[],"['craving and anxiety', 'stress and trauma scripts', 'Trauma- and Stress-Induced Craving', 'fear, anger and sadness and significantly lower ratings of joy and relaxation', 'craving, anxiety and mood']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",28.0,0.0529056,"Stress and trauma scripts produced significantly more fear, anger and sadness and significantly lower ratings of joy and relaxation than the neutral script.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ralevski', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George St. New Haven, CT 06511, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Southwick', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George St. New Haven, CT 06511, USA.'}, {'ForeName': 'Ismene', 'Initials': 'I', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George St. New Haven, CT 06511, USA.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agz092']
3359,32026713,Information growth for sequential monitoring of clinical trials with a stepped wedge cluster randomized design and unknown intracluster correlation.,"BACKGROUND/AIMS


In a stepped wedge study design, study clusters usually start with the baseline treatment and then cross over to the intervention at randomly determined times. Such designs are useful when the intervention must be delivered at the cluster level and are becoming increasingly common in practice. In these trials, if the outcome is death or serious morbidity, one may have an ethical imperative to monitor the trial and stop before maximum enrollment if the new therapy is proven to be beneficial. In addition, because formal monitoring allows for the stoppage of trials when a significant benefit for new therapy has been ruled out, their use can make a research program more efficient. However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods. Both the correlation of observations introduced by the clustered randomization and the timing of crossover from one treatment to the other impact the rate of information growth, an important component of an interim analysis.
METHODS


We simulated cross-sectional stepped wedge study data in order to evaluate the impact of sequential monitoring on the Type I error and power when the true intracluster correlation is unknown. We studied the impact of varying intracluster correlations, treatment effects, methods of estimating the information growth, and boundary shapes.
RESULTS


While misspecified information growth can impact both the Type I error and power of a study in some settings, we observed little inflation of the Type I error and only moderate reductions in power across a range of misspecified information growth patterns in our simulations.
CONCLUSION


Taking the study design into account and using either an estimate of the intracluster correlation from the ongoing study or other data in the same clusters should allow for easy implementation of group sequential methods in future stepped wedge designs.",2020,"However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods.",[],[],['death or serious morbidity'],[],[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0910909,"However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods.","[{'ForeName': 'Siobhan P', 'Initials': 'SP', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': 'Division of Biostatistics, The Ohio State University, Columbus, OH, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520901488']
3360,32025817,Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.,"PURPOSE


This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2.
METHODS


We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events.
RESULTS


High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
CONCLUSION


This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.",2020,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","['336 consecutive patients with malignant colorectal obstruction underwent SEMS placement', 'patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2', 'obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials']","['endoscopic placement of self-expandable metallic stents (SEMSs', 'SEMS placement', 'self-expandable metallic stents']","['success rates', 'mean stricture length', 'efficacy and safety', 'technical success and adverse events', 'degree of stricture', 'adverse event rate', 'clinical success, defined as resolution of symptoms and radiological findings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",336.0,0.0751036,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. ohki.takeshi@twmu.ac.jp.""}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isayama', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Matsuzawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kuwai', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Shiratori', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomio', 'Initials': 'T', 'LastName': 'Hirakawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Saida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}]",Surgery today,['10.1007/s00595-020-01970-3']
3361,29271275,Usefulness of psychoeducational intervention in chronic insomnia: an actigraphic study.,"Background : Chronic Insomnia is a severe and disabling condition characterized by difficulty in initiating or maintaining sleep, waking up too early, despite adequate opportunity and circumstances for sleep. Maladaptive thoughts and dysfunctional beliefs about sleep are considered crucial factors in developing and perpetuating this disorder. Aims : The aim of the study was to explore the usefulness, in patients with chronic insomnia, of a one-session psychoeducational intervention on sleep-related maladaptive thoughts and beliefs, and on sleep perception. Methods : Thirty-eight patients with chronic insomnia were enrolled in the study and randomly assigned to receive psychoeducational intervention (PI+) or to act as controls (PI-). Patients wore an actigraph and compiled a sleep diary for 14 d. After the first 7 d, only PI+ patients received one session of psychoeducational intervention. Results : A significant reduction of sleep related preoccupations, a reduction of dysfunctional beliefs about sleep, and an improvement of subjective perception of sleep were observed in the PI+ group, but not in the PI- group. No significant modification was observed for objective total sleep time. Conclusions : Our results suggest that one-session psychoeducational intervention is associated with a decrease of sleep-related maladaptive thoughts and beliefs, and with an improvement on subjective sleep perception.",2020,"Our results suggest that one-session psychoeducational intervention is associated with a decrease of sleep-related maladaptive thoughts and beliefs, and with an improvement on subjective sleep perception.","['chronic insomnia', 'patients with chronic insomnia, of a one-session psychoeducational intervention on sleep-related maladaptive thoughts and beliefs, and on sleep perception', 'Patients wore an actigraph and compiled a sleep diary for 14\xa0d', 'Thirty-eight patients with chronic insomnia']","['psychoeducational intervention', 'psychoeducational intervention (PI+) or to act as controls (PI']","['subjective sleep perception', 'objective total sleep time', 'subjective perception of sleep']","[{'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",38.0,0.0169512,"Our results suggest that one-session psychoeducational intervention is associated with a decrease of sleep-related maladaptive thoughts and beliefs, and with an improvement on subjective sleep perception.","[{'ForeName': 'Maria Isabella', 'Initials': 'MI', 'LastName': 'Quintiliani', 'Affiliation': 'Department of Human Sciences, European University, Rome, Italy and.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Imperatori', 'Affiliation': 'Department of Human Sciences, European University, Rome, Italy and.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Testani', 'Affiliation': 'Institute of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Losurdo', 'Affiliation': 'Institute of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Tamburello', 'Affiliation': 'Department of Human Sciences, European University, Rome, Italy and.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Contardi', 'Affiliation': 'Department of Human Sciences, European University, Rome, Italy and.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Della Marca', 'Affiliation': 'Institute of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Farina', 'Affiliation': 'Department of Human Sciences, European University, Rome, Italy and.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2017.1417563']
3362,31904682,Water Exchange (WE) and Quality Improvement-Enhanced Advanced Adenoma Detection: A Pooled Data Analysis of 6 Randomized Controlled Trials.,"INTRODUCTION


Advanced adenomas (≥10 mm in diameter, >25% villous, or high-grade dysplasia), a marker of colorectal cancer risk, are used to stratify patients for closer surveillance. Modern accessories, endoscopes, and age-adjusted evaluation have variable impacts on the advanced adenoma detection rate (AADR). In 1 randomized controlled trial (RCT) comparing air insufflation (AI) with water exchange (WE), the right colon AADR was significantly increased by WE. Four network meta-analyses reported that WE significantly increased overall adenoma detection rate (ADR), but the impact on AADR was not addressed.
AIM


The aim of this study was to test the hypothesis that WE significantly increased AADR compared with AI.
METHOD


Six Clinicaltrial.gov-registered RCTs were reported by a group of WE investigators. Data including AADR (primary outcome) and overall ADR (secondary outcome) were pooled.
RESULTS


A total of 5407 patients were randomized to AI (2699) and WE (2708). Compared with AI, WE significantly increased AADR (5.7% vs. 8.3%, P=0.001) and overall ADR (20.9% vs. 27.4%, P=0.001).
CONCLUSIONS


In contrast to published reports, which showed variable impacts on AADR, WE was consistent in increasing AADR in 6 reported RCTs. The pooled data confirm that the impact of WE in increasing AADR was significant. The significantly enhanced overall ADR indicated that WE provided a higher quality outcome than AI. The significant improvement in AADR confirmed WE to be clinically relevant and has finally arrived as a timely addition to colorectal cancer prevention programs.",2020,"Compared with AI, WE significantly increased AADR (5.7% vs. 8.3%, P=0.001) and overall ADR (20.9% vs. 27.4%, P=0.001).
",['5407 patients'],['air insufflation (AI) with water exchange (WE'],"['right colon AADR', 'Water Exchange (WE) and Quality Improvement-Enhanced Advanced Adenoma Detection', 'advanced adenoma detection rate (AADR', 'AADR', 'overall adenoma detection rate (ADR', 'overall ADR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",5407.0,0.190986,"Compared with AI, WE significantly increased AADR (5.7% vs. 8.3%, P=0.001) and overall ADR (20.9% vs. 27.4%, P=0.001).
","[{'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS).'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Graduate Institution of Long-term Care, Tzu Chi University of Science and Technology.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS).'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Department of Gastroenterology, UC Davis Medical Center, Sacramento.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cadoni', 'Affiliation': 'Digestive Endoscopy Unit, St. Barbara Hospital, Iglesias (CI).'}, {'ForeName': 'Premysl', 'Initials': 'P', 'LastName': 'Falt', 'Affiliation': 'University Hospital and Faculty of Medicine, Olomouc.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}, {'ForeName': 'Chi-Tan', 'Initials': 'CT', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, Tzu Chi University, Hualien City, Hualien.'}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Division of Digestive Endoscopy and Gastroenterology, Valduce Hospital, Como, Italy.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001311']
3363,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
3364,32027150,Outcomes of a reflective parenting program among military spouses: The moderating role of social support.,"The post-9/11 conflicts have taken a substantial toll on military families. Although positive effects of reintegration-focused programs are well-documented for service members, less is known about military spouses who are parents of young children. This article examines the outcomes of a formal reflective parenting program developed for military families who have very young children, and whether aspects of informal social support moderate spouse outcomes of anxiety, depression, and parenting stress. Data are drawn from a randomized, clinical trial (RCT) of 103 military families with children ages birth to 5 years of age. Structural equation models examined the main effects of the program and the relationship of 3 social support dimensions (perceived support, social connectedness and dyadic satisfaction) to program outcomes of interest. Analyses revealed a statistically significant reduction in anxiety in the treatment group, with a small effect size. No significant program effects emerged on parenting stress or depression. None of the social support dimensions was significantly associated with outcomes of interest. The interaction of dyadic support and treatment showed a significant moderate effect on parenting stress. Spouses with lower baseline satisfaction who were assigned to the treatment condition reported similar levels of parenting stress at baseline and posttest, whereas their counterparts in the waitlist condition reported significantly higher parenting stress at posttest compared with baseline. Findings suggest a targeted approach to preventive intervention for military spouses who are mothers of young children. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Spouses with lower baseline satisfaction who were assigned to the treatment condition reported similar levels of parenting stress at baseline and posttest, whereas their counterparts in the waitlist condition reported significantly higher parenting stress at posttest compared with baseline.","['military spouses', '103 military families with children ages birth to 5 years of age', 'military spouses who are mothers of young children', 'military spouses who are parents of young children', 'military families who have very young children']","['formal reflective parenting program', 'reflective parenting program']","['levels of parenting stress', 'anxiety', 'parenting stress or depression', 'parenting stress']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C3850016', 'cui_str': 'Families of Military Personnel'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",103.0,0.0250074,"Spouses with lower baseline satisfaction who were assigned to the treatment condition reported similar levels of parenting stress at baseline and posttest, whereas their counterparts in the waitlist condition reported significantly higher parenting stress at posttest compared with baseline.","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Ross', 'Affiliation': 'Graduate School of Social Service, Fordham University.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'DeVoe', 'Affiliation': 'School of Social Work, Boston University.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Steketee', 'Affiliation': 'School of Social Work, Boston University.'}, {'ForeName': 'Benjamin O', 'Initials': 'BO', 'LastName': 'Emmert-Aronson', 'Affiliation': 'Open Source Wellness.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Muroff', 'Affiliation': 'School of Social Work, Boston University.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000637']
3365,32029375,Eye Shielding During Head CT Scans: Dose Reduction and Image Quality Evaluation.,"RATIONALE AND OBJECTIVES


In this study, we assessed the radiation dose to the lens and the impacts of various eye shields using either a fixed or modulated tube current.
MATERIALS AND METHODS


Patients undergoing head computed tomography (CT) examinations were recruited, and each was randomly assigned to one of five imaging groups, either without a CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM). The radiation dose at the eye lens was estimated using Gafchromic films. All CT images were analyzed for quality in the orbit and brain areas. Two radiologists also qualitatively assessed image artifacts and their impacts on image quality using three-point Likert scales.
RESULTS


Both barium sulfate and bismuth-antimony shields significantly reduced radiation dose to the lens (by 28.60%-31.92% and 43.87%-47.00%, respectively) while significantly inducing image artifacts. The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding. In addition, discriminating the periocular tissues was improved using a bismuth-antimony shield and topogram-based TCM. Compared to fixed tube current, topogram-based TCM provided better signal-to-noise and contrast-to-noise ratios in the intracranial structures when the bismuth-antimony and barium sulfate shields were applied, respectively.
CONCLUSION


Artifacts resulting from the application of eye shields during head CT examinations can be reduced by using topogram-based TCM instead of a fixed tube current. This could be an alternative approach for maintaining image quality in CT scans that do not encompass organ-based TCM.",2020,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.",['Patients undergoing head computed tomography (CT) examinations'],"['CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM', 'barium sulfate and bismuth-antimony', 'bismuth-antimony shield and topogram-based TCM', 'fixed tube current, topogram-based TCM']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0412670', 'cui_str': 'Digital slit-beam radiograph (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0004754', 'cui_str': 'Barium Sulfate'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0202321', 'cui_str': 'Antimony measurement (procedure)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}]",[],,0.0241579,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.","[{'ForeName': 'Yuan-Hao', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Biostatistics Center, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Randolph D', 'Initials': 'RD', 'LastName': 'Glickman', 'Affiliation': 'Department of Ophthalmology, University of Texas Health Science Center, San Antonio, Texas.'}, {'ForeName': 'Chia-Yuen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Wing P', 'Initials': 'WP', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: wingchan@tmu.edu.tw.'}]",Academic radiology,['10.1016/j.acra.2019.12.011']
3366,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
3367,31886931,Evaluation of the longitudinal change in health behavior profiles across treatment groups in the TODAY clinical trial.,"BACKGROUND


Individual health behaviors (ie, eating habits and sedentary lifestyle) are associated with type 2 diabetes (T2D). Health behavior profiles specific to adolescents with T2D have not been described.
OBJECTIVE


To identify health behavior profiles in adolescents with T2D and examine how these profiles change over time.
METHODS


Diet (via food frequency questionnaire) and activity behaviors (via 3-day physical activity recall) examined at baseline, 6 months, and 24 months from participants in the the Treatment Options for T2D in Adolescents and Youth (TODAY) study were used for this analysis. Latent profile analysis identified profiles of health behaviors within three time points, and latent transition probabilities were estimated to examine the change from baseline to 6 months (n = 450) and baseline to 24 months (n = 415). Multinomial logistic regressions were used to examine if the assigned TODAY treatment group (Metformin [Met], Met + Rosiglitazone [Rosi], or Met + Lifestyle) predicted change in health behavior profiles.
RESULTS


Three profiles emerged: ""most sedentary,"" ""healthy eaters,"" and ""active and eat most."" At 6 months, 50% of males and 29% of females in the Met + Lifestyle treatment group improved in their health behavior profile. Among males only, the Met + Lifestyle treatment group were more likely to improve their profiles from baseline to 6 months (P = .01).
CONCLUSIONS


Three health behavior profiles emerged and shifted over time. A high quality, lifestyle intervention had little effect on improving health behavior profiles. Optimizing outcomes in youth with T2D might require more robust and multifaceted interventions beyond family-level lifestyle, including more extensive psychosocial intervention, novel medication regimen, or bariatric surgery.",2020,"Among males only, the Met + Lifestyle treatment group were more likely to improve their profiles from baseline to 6 months (p=0.01).
",['adolescents with T2D'],"['Metformin (Met), Met + Rosiglitazone (Rosi), or Met + Lifestyle']","['health behavior profile', 'health behavior profiles']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",[{'cui': 'C0018687'}],,0.0313876,"Among males only, the Met + Lifestyle treatment group were more likely to improve their profiles from baseline to 6 months (p=0.01).
","[{'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Kaar', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington DC.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walders-Abramson', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Willi', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado.'}]",Pediatric diabetes,['10.1111/pedi.12976']
3368,31836203,Corneal epithelial thickness and corneal curvature changes during the day: The effects of daily disposable contact lens wear.,"PURPOSE


To evaluate the changes in corneal epithelial thickness and corneal anterior and posterior curvatures during the day, and the effect of wearing daily disposable soft contact lenses.
METHODS


Thirty-two healthy volunteers were enrolled in a randomized crossover study. At the baseline visit, corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany) were performed in the morning and in the afternoon (8 hours after). Then, each subject was fitted with the following brands of daily disposable contact lenses in random order: Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue Oneday (Nesofilcon A) on different days. All fitted lenses had a power of -3.00 diopters (D). Measurements were repeated before putting the contact lens on and after an-eight-hour contact lens wear.
RESULTS


With no lens wear, the anterior topographic indices showed significant steepening [Kflat: p < 0.0001; Ksteep: p < 0.0001 and maximum keratometry value (Kmax): p = 0.04] and the corneal thickness significantly decreased in the central and temporal portion of the cornea in the afternoon. There were no significant changes in the posterior topographical indices and corneal epithelial thickness. With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05). There was no statistically significant difference in the epithelial thickness among the groups wearing different contact lens types (p > 0.05).
CONCLUSIONS


Anterior corneal topographic indices steepen depending on the natural diurnal variations. Daily wear of soft contact lenses appears to mask this steepening. The corneal epithelial thickness is not affected by daily disposable soft contact lenses.",2020,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).",['Thirty-two healthy volunteers'],"['daily disposable contact lens wear', 'soft contact lenses']","['Corneal epithelial thickness and corneal curvature changes', 'Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue', 'corneal thickness', 'epithelial thickness', 'corneal epithelial thickness and corneal anterior and posterior curvatures', 'corneal epithelial thickness', 'corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany', 'posterior topographical indices and corneal epithelial thickness', 'corneal and epithelial thickness, and the anterior and posterior curvatures']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",32.0,0.0226964,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).","[{'ForeName': 'Semra Akkaya', 'Initials': 'SA', 'LastName': 'Turhan', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: semraakkaya85@hotmail.com.'}, {'ForeName': 'Didem Dizdar', 'Initials': 'DD', 'LastName': 'Yigit', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: drdidemdizdar@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Toker', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: dretoker@gmail.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.11.017']
3369,31976786,"Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline  BRCA/PALB2  Mutation.","PURPOSE


Five percent to 9% of pancreatic ductal adenocarcinomas (PDACs) develop in patients with a germline  BRCA1/2  or  PALB2  (g BRCA/PALB2 +) mutation. Phase IB data from a trial that used cisplatin, gemcitabine, and veliparib treatment demonstrated a high response rate (RR), disease control rate (DCR), and overall survival (OS) in this population. We designed an open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine with or without veliparib in g BRCA/PALB2 + PDAC.
PATIENTS AND METHODS


Eligible patients had untreated g BRCA/PALB2+  PDAC with measurable stage III to IV disease and Eastern Cooperative Oncology Group performance status of 0 to 1. Treatment for patients in arm A consisted of cisplatin 25 mg/m 2  and gemcitabine 600 mg/m 2  intravenously on days 3 and 10; treatment for patients in arm B was the same as that for patients in arm A, and arm A also received veliparib 80 mg orally twice per day on days 1 to 12 cycled every 3 weeks. The primary end point was RRs of arm A and arm B evaluated separately using a Simon two-stage design. Secondary end points were progression-free survival, DCR, OS, safety, and correlative analyses.
RESULTS


Fifty patients were evaluated by modified intention-to-treat analysis. The RR for arm A was 74.1% and 65.2% for arm B ( P  = .55); both arms exceeded the prespecified activity threshold. DCR was 100% for arm A and 78.3% for arm B ( P  = .02). Median progression-free survival was 10.1 months for arm A (95% CI, 6.7 to 11.5 months) and 9.7 months for arm B (95% CI, 4.2 to 13.6 months;  P  = .73). Median OS for arm A was 15.5 months (95% CI, 12.2 to 24.3 months) and 16.4 months for arm B (95% CI, 11.7 to 23.4 months;  P  = .6). Two-year OS rate for the entire cohort was 30.6% (95% CI, 17.8% to 44.4%), and 3-year OS rate was 17.8% (95% CI, 8.1% to 30.7%). Grade 3 to 4 hematologic toxicities for arm A versus arm B were 13 (48%) versus seven (30%) for neutropenia, 15 (55%) versus two (9%) for thrombocytopenia, and 14 (52%) versus eight (35%) for anemia.
CONCLUSION


Cisplatin and gemcitabine is an effective regimen in advanced g BRCA/PALB2 + PDAC. Concurrent veliparib did not improve RR. These data establish cisplatin and gemcitabine as a standard approach in g BRCA / PALB2 + PDAC.",2020,The RR for arm A was 74.1% and 65.2% for arm B ( P  = .55); both arms exceeded the prespecified activity threshold.,"['Eligible patients had untreated g BRCA/PALB2+  PDAC with measurable stage III to IV disease and Eastern Cooperative Oncology Group performance status of 0 to 1', 'Fifty patients', 'patients with a germline  BRCA1/2  or  PALB2  (g BRCA/PALB2 +) mutation', 'Patients With Pancreas Adenocarcinoma and a Germline  BRCA/PALB2  Mutation']","['cisplatin 25 mg/m 2  and gemcitabine', 'cisplatin and gemcitabine with or without veliparib in g BRCA/PALB2 + PDAC', 'Gemcitabine and Cisplatin', 'cisplatin, gemcitabine, and veliparib treatment', 'Cisplatin and gemcitabine', 'veliparib', 'cisplatin and gemcitabine']","['3-year OS rate', 'high response rate (RR), disease control rate (DCR), and overall survival (OS', 'Median progression-free survival', 'DCR', 'Grade 3 to 4 hematologic toxicities', 'thrombocytopenia', 'Median OS', 'OS rate', 'neutropenia', 'RR', 'progression-free survival, DCR, OS, safety, and correlative analyses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",50.0,0.0643681,The RR for arm A was 74.1% and 65.2% for arm B ( P  = .55); both arms exceeded the prespecified activity threshold.,"[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zalupski', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Golan', 'Affiliation': 'Chaim Sheba Medical Center at Tel HaShomer, Tel HaShomer, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Tahover', 'Affiliation': ""The Oncology Institute, Sha'are Zedek Medical Center, Jerusalem, Israel.""}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity College, Dublin, Ireland.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Brenner', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hedy L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Vemuri', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Zsofia K', 'Initials': 'ZK', 'LastName': 'Stadler', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard K G', 'Initials': 'RKG', 'LastName': 'Do', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Dhani', 'Affiliation': 'Princess Margaret Cancer Centre-University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02931']
3370,32020044,Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS.,"More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (""3 + 7"") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m 2  twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).",2020,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"['older AML patients', 'patients with acute myeloid leukemia (AML) of older age', 'elderly patients with AML', 'older patients with AML and high-risk MDS']","['Lenalidomide', 'cytarabine 1000\u2009mg/m 2  twice daily on days 1-6 with or without lenalidomide', 'standard chemotherapy (""3\u2009+\u20097"") with or without lenalidomide']","['frequencies and grade of adverse events', 'Event-free survival (EFS', 'CR/CRi rates', 'Cardiovascular toxicities', 'overall survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.103256,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands. g.ossenkoppele@amsterdamumc.nl.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Breems', 'Affiliation': 'Netwerk Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stuessi', 'Affiliation': 'Bellinzona-IOSI, Bellinzona, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'van Norden', 'Affiliation': 'HOVON Data Center, Erasmus MC- Department of Hematology, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bargetzi', 'Affiliation': 'Aarau- Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'A von dem Borne', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'University Hospital and University of Geneva, Genève, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Roeselare-AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'St Gallen-Kantonnsspital, St. Gallen, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gjertsen', 'Affiliation': 'Haukeland University Hospital, Bergen (N), Norway.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graux', 'Affiliation': 'Yvoir-MontGodinne, Yvoir, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'University Medical Center, Groningen, Netherlands.'}, {'ForeName': 'J J J W', 'Initials': 'JJJW', 'LastName': 'Janssen', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jaspers', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Dordrecht ASZ, Dordrecht, Netherlands.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Amphia-Breda, Breda, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Hospital Gasthuisberg, Leuven (B), Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Michaux', 'Affiliation': 'Center for Human Genetics, KU Leuven and University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Rhenen', 'Affiliation': 'UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'MaximaMC Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Valk', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Vekemans', 'Affiliation': 'Hôpital St Luc, Bruxelles, Belgium.'}, {'ForeName': 'W J F M', 'Initials': 'WJFM', 'LastName': 'van der Velden', 'Affiliation': 'Radboudumc Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manz', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0725-0']
3371,30648450,Appearance Framing versus Health Framing of Health Advice: Assessing the Effects of a YouTube Channel for Adolescent Girls.,"The present experimental study tested the effects of appearance framing of health advice on adolescent girls' state self-objectification, appearance anxiety, and preference for appearance-enhancing products. The stimuli consisted of informative YouTube-style videos about doing yoga, drinking water, or using sunscreen, and these videos were either appearance-framed (experimental condition) or health-framed (control condition). In total, 154 adolescent girls ( M age  = 15.67,  SD  = 1.07) participated in the experiment. The effect of appearance-framed videos on state self-objectification scores was moderated by age, such that the effect of viewing the appearance-framed videos positively predicted state self-objectification among the younger adolescents. In addition, self-objectification mediated the effect of condition on appearance anxiety and on their appearance-enhancing product preferences, again with the predicted effects supported for the younger adolescents in the sample.",2020,"In addition, self-objectification mediated the effect of condition on appearance anxiety and on their appearance-enhancing product preferences, again with the predicted effects supported for the younger adolescents in the sample.","['Adolescent Girls', '154 adolescent girls (M age \xa0=\xa015.67, SD\xa0=\xa01.07) participated in the experiment']","['Appearance Framing versus Health Framing of Health Advice', 'appearance-framed videos', 'informative YouTube-style videos about doing yoga, drinking water, or using sunscreen, and these videos were either appearance-framed (experimental condition) or health-framed (control condition', 'appearance framing of health advice', 'YouTube Channel']",['state self-objectification scores'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",154.0,0.0171605,"In addition, self-objectification mediated the effect of condition on appearance anxiety and on their appearance-enhancing product preferences, again with the predicted effects supported for the younger adolescents in the sample.","[{'ForeName': 'Jennifer Stevens', 'Initials': 'JS', 'LastName': 'Aubrey', 'Affiliation': 'Department of Communication, University of Arizona.'}, {'ForeName': 'Ashton Gerding', 'Initials': 'AG', 'LastName': 'Speno', 'Affiliation': 'Department of Mass Communications, Southern Illinois University Edwardsville.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Gamble', 'Affiliation': 'Department of Communication and Theatre, Auburn University-Montgomery.'}]",Health communication,['10.1080/10410236.2018.1564955']
3372,31818723,A Randomized Study Comparing Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Therapy in a Sample of Women Struggling to Achieve Orgasm.,"INTRODUCTION


This study examines the effectiveness of integrating mindfulness-based techniques within therapy for women suffering to achieve orgasm. Although widely applied in psychotherapy, this approach has only recently been introduced in the treatment of female sexual dysfunction.
AIM


To compare the effectiveness of a video-based self-administered treatment, rooted within the cognitive behavioral treatment (CBT) framework, with a video-based self-administered mindfulness treatment applying cognitive behavioral sexual therapy (mindfulness-based cognitive therapy), the latter of which was specifically created to increase women's ability to achieve orgasm.
METHODS


A convenience sample of 65 women suffering from difficulties to achieve orgasm, aged 18 to 58 years (mean = 32.66, standard deviation = 9.48), were randomly allocated using a randomization procedure to either a mindfulness-based cognitive therapy (N = 35) or CBT (N = 30) group. Each participant completed questionnaires before and after the start of treatment and 2 months after its completion.
MAIN OUTCOME MEASURE


We applied repeated-measure general linear models to compare the 2 groups (ie, between participant factor) on each dependent variable across time (ie, the within-participant factor). Compare mean analyses for paired samples were only conducted when the interaction effect between condition and time was significant (ie, P <.05).
RESULTS


Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments. Contrary to our hypothesis, significant reductions in sexual pain were only observed in CBT participants.
CLINICAL IMPLICATIONS


To the best of our knowledge, this is the first study to apply a randomized allocation procedure to evaluate the effectiveness of a video-based mindfulness intervention for women struggling to achieve orgasm. These results should guide clinicians' decisions with respect to evaluating the relevance and the real added value of proposing mindfulness exercises to their patients with such difficulties.
CONCLUSION


When women suffering from difficulties to achieve orgasm are randomly assigned to a mindfulness group or an active control, improvements in sexual functioning and reductions in sexual distress can be observed after both treatments. Adam F, De Sutter P, Day J, et al. A Randomized Study Comparing Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Treatment in a Sample of Women Struggling to Achieve Orgasm. J Sex Med 2020;17:312-324.",2020,"RESULTS


Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments.","['65 women suffering from difficulties to achieve orgasm, aged 18 to 58 years (mean\xa0= 32.66, standard deviation\xa0= 9.48', 'a Sample of Women Struggling to Achieve Orgasm', 'women suffering from difficulties to achieve orgasm', 'women struggling to achieve orgasm', 'women suffering to achieve orgasm', 'a Sample of Women']","['integrating mindfulness-based techniques within therapy', 'video-based mindfulness intervention', 'mindfulness-based cognitive therapy (N\xa0= 35) or CBT', 'Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Treatment', 'Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Therapy', 'video-based self-administered treatment, rooted within the cognitive behavioral treatment (CBT) framework, with a video-based self-administered mindfulness treatment applying cognitive behavioral sexual therapy (mindfulness-based cognitive therapy']","['sexual functioning', 'sexual pain', 'sexual functioning and reductions in sexual distress', 'improved desire, arousal, orgasm, and sexual satisfaction', 'sexual distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}]",65.0,0.0244962,"RESULTS


Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments.","[{'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Adam', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium. Electronic address: francoise.adam@uclouvain.be.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'De Sutter', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Grimm', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.022']
3373,31820546,Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial.,"AIM


Describe the distinguishing features of heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial.
METHODS AND RESULTS


Key background characteristics were evaluated in 5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event. Differences within the VICTORIA population were assessed and compared with PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure). VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  . Baseline standard of HF care was very good: 60% received triple therapy. Their N-terminal pro-B-type natriuretic peptide was 3377 pg/mL [interquartile range (IQR) 1992-6380]. Natriuretic peptides were 30% higher level in the 67% patients with HF hospitalization <3 months, compared to those within 3-6 months of HF hospitalization and those randomized after recent outpatient intravenous diuretic therapy. Overall the median MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) risk score in VICTORIA was 23 (IQR 18-27) as compared to the MAGGIC risk score in PARADIGM-HF of 20 (IQR 16-24).
CONCLUSIONS


VICTORIA comprises a broadly generalizable high-risk population of three unique clinical strata of worsening chronic HFrEF despite very good HF therapy. VICTORIA will establish the role of vericiguat, a soluble guanylate cyclase stimulator, in HFrEF.",2019,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","['Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure', '5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event', 'Subjects with Heart Failure with Reduced Ejection Fraction) trial', 'heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial']",['Rivaroxaban'],"['Natriuretic peptides', 'Risk of Death, Myocardial Infarction, or Stroke', 'risk of mortality and rehospitalization', 'glomerular filtration rate', 'atrial fibrillation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",5050.0,0.0885492,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","[{'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Groningen Heart Failure Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1664']
3374,31662210,The effect of executive function on adherence with a cardiac secondary prevention program and its interaction with an incentive-based intervention.,"Participation in secondary prevention programs such as cardiac rehabilitation (CR) reduces morbidity, mortality, and hospitalizations while improving quality of life. Executive function (EF) is a complex set of cognitive abilities that control and regulate behavior. EF predicts many health-related behaviors, but how EF interacts with interventions to improve treatment adherence is not well understood. The objective of this study is to examine if EF predicts CR treatment adherence and how EF interacts with an intervention to improve adherence. Data were collected from 2013 to 2018 in Vermont, USA. 130 Medicaid-enrolled individuals who had experienced a qualifying cardiac event were enrolled in a controlled clinical trial and randomized 1:1 to receive financial incentives for completing secondary prevention sessions or to usual care. In this secondary analysis, effects of EF on CR adherence (defined as completing ≥30/36 sessions) were examined in 112 participants (57 usual care, 55 intervention) who completed an EF battery. Delay-discounting, a measure of impulsivity, predicted CR adherence (p = 0.01) and interacted with the incentive intervention, such that those who exhibited greater discounting of future rewards benefitted more from the intervention than those who discounted less (F(1, 104) = 5.23, p = 0.02). Better cognitive flexibility, measured with the trail-making-task, also predicted CR adherence (p = 0.02). While EF has been associated with adherence to a variety of treatment regimens, this interaction between an incentive-based intervention to promote treatment adherence and EF is novel. This work illustrates the value of considering individual differences in EF when designing and implementing interventions to promote health-related behavior change.",2019,"Better cognitive flexibility, measured with the trail-making-task, also predicted CR adherence (p = 0.02).","['130 Medicaid-enrolled individuals who had experienced a qualifying cardiac event', '112 participants (57 usual care, 55 intervention) who completed an EF battery']","['financial incentives for completing secondary prevention sessions or to usual care', 'executive function', 'EF']","['Delay-discounting, a measure of impulsivity, predicted CR adherence', 'cardiac rehabilitation (CR) reduces morbidity, mortality, and hospitalizations while improving quality of life', 'CR adherence', 'Better cognitive flexibility']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",130.0,0.0366044,"Better cognitive flexibility, measured with the trail-making-task, also predicted CR adherence (p = 0.02).","[{'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'University of Vermont, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America. Electronic address: dgaalema@uvm.edu.'}, {'ForeName': 'Sarahjane', 'Initials': 'S', 'LastName': 'Dube', 'Affiliation': 'University of Vermont, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Potter', 'Affiliation': 'University of Vermont, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'University of Vermont, United States of America.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Mahoney', 'Affiliation': 'University of Vermont, United States of America.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'University of Vermont, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'University of Vermont, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Ades', 'Affiliation': 'University of Vermont, United States of America; University of Vermont Medical Center, United States of America; Vermont Center on Behavior and Health, Burlington, VT, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105865']
3375,32005308,Risk of hearing loss among multidrug-resistant tuberculosis patients according to cumulative aminoglycoside dose.,"SETTING:  The ototoxic effects of aminoglycosides (AGs) lead to permanent hearing loss, which is one of the devastating consequences of multidrug-resistant tuberculosis (MDR-TB) treatment. As AG ototoxicity is dose-dependent, the impact of a surrogate measure of AG exposure on AG-induced hearing loss warrants close attention for settings with limited therapeutic drug monitoring. OBJECTIVE:  To explore the prognostic impact of cumulative AG dose on AG ototoxicity in patients following initiation of AG-containing treatment for MDR-TB. DESIGN:  This prospective cohort study was nested within an ongoing cluster-randomized trial of nurse case management intervention across 10 MDR-TB hospitals in South Africa. RESULTS:  The adjusted hazard of AG regimen modification due to ototoxicity in the high-dose group (≥75 mg/kg/week) was 1.33 times higher than in the low-dose group (<75 mg/kg/week, 95%CI 1.09-1.64). The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77). Pre-existing hearing loss (adjusted hazard ratio [aHR] 1.71, 95%CI 1.29-2.26) and age (aHR 1.16 per 10 years of age, 95%CI 1.01-1.33) were also associated with an increased risk of hearing loss. CONCLUSION:  MDR-TB patients with high AG dose, advanced age and pre-existing hearing loss have a significantly higher risk of AG-induced hearing loss. Those at high risk may be candidates for more frequent monitoring or AG-sparing regimens.",2020,The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77).,"['multidrug-resistant tuberculosis patients', 'patients following initiation of AG-containing treatment for MDR-TB', 'across 10 MDR-TB hospitals in South Africa']","['nurse case management intervention', 'aminoglycosides (AGs']","['ototoxicity', 'adjusted hazard of developing audiometric hearing loss', 'Pre-existing hearing loss', 'hearing loss', 'risk of hearing loss']","[{'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]","[{'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0781323,The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Divisions of Clinical Pharmacology and Infectious Disease, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Francis', 'Affiliation': 'Division of Head and Neck Surgery and Communication Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'H-R', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, Center for Cardiovascular and Chronic Care, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Farley', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0062']
3376,32000193,"Effects of Video Discharge Instructions on Patient Understanding: A Prospective, Randomized Trial.","Previous studies demonstrated that patients have difficulty understanding and retaining discharge instructions due to the lack of time spent counseling patients and low health literacy rates. The purpose of this study was to evaluate the effects of video instructions on patient understanding of their discharge instructions. This was a prospective, randomized, controlled trial of a convenience sample conducted in a military hospital emergency department. Adult patients with a diagnosis of upper respiratory tract infection, pharyngitis, or gastroenteritis were included into the study. Investigators randomized subjects to either standard discharge procedures or standard discharge procedures plus video discharge instructions, using a random number generator. Ten minutes after receiving one of these 2 discharge education methods, subjects demonstrated their knowledge of their discharge instructions using a predefined 5-question, multiple-choice questionnaire. From October 1, 2015, to January 8, 2016, a total of 60 subjects volunteered to participate in the study. Zero subjects were excluded, and all subjects completed the study protocol. Baseline characteristics between groups were not significantly different (30 video discharge instructions and 30 standard discharge instructions). We found a significant difference between groups with respect to discharge instructions knowledge in favor of the video discharge instructions group (4.53 vs. 4; p = 0.009). Video discharge instructions, used as an adjunct to standard verbal and written discharge methods, improved patient understanding and retention of their discharge instructions.",2020,We found a significant difference between groups with respect to discharge instructions knowledge in favor of the video discharge instructions group (4.53 vs. 4; p = 0.009).,"['Patient Understanding', 'convenience sample conducted in a military hospital emergency department', 'Adult patients with a diagnosis of upper respiratory tract infection, pharyngitis, or gastroenteritis were included into the study', 'From October 1, 2015, to January 8, 2016, a total of 60 subjects volunteered to participate in the study']","['standard discharge procedures or standard discharge procedures plus video discharge instructions', 'Video Discharge Instructions', 'video instructions']",['discharge instructions knowledge'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",60.0,0.0812211,We found a significant difference between groups with respect to discharge instructions knowledge in favor of the video discharge instructions group (4.53 vs. 4; p = 0.009).,"[{'ForeName': 'Zebulon L', 'Initials': 'ZL', 'LastName': 'Wilkin', 'Affiliation': 'William Beaumont Army Medical Center, Fort Bliss, Texas.'}]",Advanced emergency nursing journal,['10.1097/TME.0000000000000279']
3377,32006386,Working memory training format in older adults: individual versus group sessions.,"Working memory (WM) training has been shown to increase the performance of participants in WM tasks and in other cognitive abilities, but there has been no study comparing directly the impact of training format (individual vs. group) using the same protocol. Therefore, the aim of this study was to compare the efficacy of the Borella et al. three session verbal WM training offered in two different formats on target and transfer tasks. This study was conducted in two waves. In the first wave, participants were randomized into individual training (n = 11) and individual control conditions (n = 15). In the second wave, participants were randomized into group training (n = 16) and group control conditions (n = 17). Training consisted of three sessions of WM exercises and participants in the active control condition responded to questionnaires during the same time. There was significant improvement for both training conditions at post-test and maintenance at follow-up for the target task, other WM tasks, processing speed, and executive functions tasks. The ANOVA results showed that the training gains did not depend on the WM training format. However, the effect size analyses suggested that this intervention can be more effective, at short term and follow-up, when provided individually. To conclude, this study showed that providing this training collectively or individually does not change the training benefits, which increases the possibilities of its use in different contexts.",2020,"There was significant improvement for both training conditions at post-test and maintenance at follow-up for the target task, other WM tasks, processing speed, and executive functions tasks.",['older adults'],"['Working memory (WM) training', 'WM exercises', 'individual training']","['WM tasks, processing speed, and executive functions tasks']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0151998,"There was significant improvement for both training conditions at post-test and maintenance at follow-up for the target task, other WM tasks, processing speed, and executive functions tasks.","[{'ForeName': 'Paula Schimidt', 'Initials': 'PS', 'LastName': 'Brum', 'Affiliation': 'Departament of Neurology, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, 5 floor, 5083, São Paulo, Brazil. pabrum@usp.br.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borella', 'Affiliation': 'Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Carretti', 'Affiliation': 'Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Mônica Sanches', 'Initials': 'MS', 'LastName': 'Yassuda', 'Affiliation': 'Departament of Neurology, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, 5 floor, 5083, São Paulo, Brazil.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01468-0']
3378,32013799,Sleep duration and risk of cardiovascular events: The SAVE study.,"BACKGROUND AND AIM


Controversy exists regarding cardiovascular risk in relation to sleep duration. We determined sleep duration and major recurrent cardiovascular event associations in patients with obstructive sleep apnoea and established cardiovascular disease.
METHODS


Secondary analyses of the international, multicenter, Sleep Apnea Cardiovascular Endpoints trial. Sleep duration was estimated from overnight home oximetry (ApneaLink monitor) used for obstructive sleep apnoea diagnosis. Cox proportional hazards models were used to determine associations of categorized sleep duration (<6 h, 6-8 h (reference), and >8 h) and major cardiovascular outcomes: primary composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and any hospitalization for unstable angina, heart failure, or transient ischemic attack; secondary composite of cardiac and cerebral (stroke/transient ischemic attack) events.
RESULTS


Oximetry-derived sleep duration estimates were available in 2687 participants (mean 61.2 years, 80.9% males) who experienced a total of 436 cardiovascular events over a mean follow-up of 3.7 years. Compared to the reference category, sleep duration was not associated with risk of the primary composite cardiovascular outcome (adjusted hazard ratio (HR) 1.00, 95% confidence interval 0.76-1.33, and HR 1.22, 95% confidence interval 0.98-1.52, for sleep duration <6 and >8 h, respectively). However, long sleep was associated with increased cerebral events (HR 1.67, 95% confidence interval 1.17-2.39;  P  = 0.005) and stroke alone (HR 1.79, 95% confidence interval 1.22-2.63;  P  = 0.003).
CONCLUSIONS


Long sleep duration is associated with an increased risk of stroke but not cardiac events in obstructive sleep apnoea patients with existing cardiovascular disease.
CLINICAL TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov (NCT00738179).",2020,"However, long sleep was associated with increased cerebral events (HR 1.67, 95% confidence interval 1.17-2.39;  P  = 0.005) and stroke alone (HR 1.79, 95% confidence interval 1.22-2.63;  P  = 0.003).
","['2687 participants (mean 61.2 years, 80.9% males) who experienced a total of 436 cardiovascular events over a mean follow-up of 3.7 years', 'patients with obstructive sleep apnoea and established cardiovascular disease', 'obstructive sleep apnoea patients with existing cardiovascular disease']",[],"['cerebral events', 'major cardiovascular outcomes: primary composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and any hospitalization for unstable angina, heart failure, or transient ischemic attack; secondary composite of cardiac and cerebral (stroke/transient ischemic attack) events', 'primary composite cardiovascular outcome (adjusted hazard ratio (HR', 'Sleep duration', 'obstructive sleep apnoea diagnosis', 'Sleep duration and risk of cardiovascular events']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",[],"[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",2687.0,0.121407,"However, long sleep was associated with increased cerebral events (HR 1.67, 95% confidence interval 1.17-2.39;  P  = 0.005) and stroke alone (HR 1.79, 95% confidence interval 1.22-2.63;  P  = 0.003).
","[{'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The 211065George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, 1065Flinders University, Adelaide, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The 211065George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, 1065Flinders University, Adelaide, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Centre for Biostatistics and Epidemiology, College of Medicine and Public Health, 1065Flinders University, Adelaide, Australia.'}, {'ForeName': 'Yuanming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, Guangzhou, China.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Heart Institute, Instituto do Coracao, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbe', 'Affiliation': 'Respiratory Department, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Institutde Recerca Biomèdica de Lleida, Madrid, Spain.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, 28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The 211065George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020904913']
3379,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
3380,32207859,Effect of autonomy support and dialogic learning on school children's physical activity and sport.,"This study applies an intervention based on autonomy support through dialogic learning to examine effects on motivation and the promotion of physical activity and sport involvement during schoolchildren's leisure time. One hundred and two primary school students, aged 11-13 years, participated (M = 10.93, SD = 0.75). The sample was divided into two groups: an experimental group (49 students) and a control group (53 students). A quasi-experimental study was conducted in physical education classes over the course of 9 months. Assessments of autonomy support from teachers, family, and peers; basic psychological needs; self-determined motivation in physical education and during leisure time; planned behavior variables; physical activity intention; and estimated and actual physical exercise behavior time were included in the model. Following the intervention, the results revealed that greater autonomy support by the teacher, the family and peers, satisfaction of the basic psychological needs, self-determined motivation during physical education class and during free time, greater perceived control, favorable attitude and intention to engage in physical activity contributed to the explanation of student physical activity involvement. These results suggest that when students receive extensive social support from diverse social agents that essential precursors to physical activity are strengthened and contribute to increased motivation and actual physical activity involvement. Efforts to promote effective communications with students and other pedagogical efforts, such as providing dialogic learning opportunities, should be considered in order to strengthen physical activity motivation and involvement in students.",2020,The sample was divided into two groups: an experimental group (49 students) and a control group (53 students).,"['One hundred and two primary school students, aged 11-13\xa0years, participated (M\xa0=\xa010.93, SD\xa0=\xa00.75', ""school children's physical activity and sport"", ""schoolchildren's leisure time""]",['autonomy support and dialogic learning'],"['actual physical exercise behavior time', 'satisfaction of the basic psychological needs, self-determined motivation during physical education class and during free time, greater perceived control, favorable attitude and intention to engage in physical activity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",102.0,0.0112826,The sample was divided into two groups: an experimental group (49 students) and a control group (53 students).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Huéscar Hernández', 'Affiliation': 'Universidad Miguel Hernández de Elche, Alicante.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Andrés Fabra', 'Affiliation': 'Universidad Miguel Hernández de Elche, Alicante.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Moreno-Murcia', 'Affiliation': 'Universidad Miguel Hernández de Elche, Alicante.'}]",Scandinavian journal of psychology,['10.1111/sjop.12637']
3381,31836300,Audiovisual Sexual Stimulation Improves Diagnostic Accuracy of Penile Doppler Ultrasound in Patients With Erectile Dysfunction.,"INTRODUCTION


Although penile Doppler ultrasound (PDU) is a useful tool in evaluating erectile dysfunction (ED), an optimal erectile response might be limited because of an increased sympathetic discharge. Audiovisual sexual stimulation (AVSS) has been suggested to help improving PDU performance.
AIM


To evaluate the use of AVSS as a tool to improve diagnostic accuracy of PDU studies.
METHODS


A total of 40 men (mean age: 61.8 ± 10.2 years) with ED were enrolled. PDU sessions were performed in a randomized fashion as follows: session A under intracavernous injection (ICI) alone and session B under ICI and AVSS with 7-day interval between sessions. Peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) were measured 5, 10, 15, and 20 minutes after ICI.
MAIN OUTCOME MEASURE


Comparisons between PSV, EDV, and RI values were performed with and without AVSS. Univariable and multivariable analyses including clinical and demographic parameters were performed to evaluate predictors of an abnormal PDU.
RESULTS


23 patients performed the first session without AVSS, and 17 performed the first session with AVSS. EDV and RI were better in AVSS session (p = 0.022 and 0.019). PSV was not influenced by AVSS (p = 0.768). The proportion of patients whose diagnosis was changed because of the AVSS was 4 of 40 (10.0%, 95% confidence interval [CI]: 2.8-23.7%). Of 12 patients with venous leak observed on the PDU without AVSS, 3 turned into normal after AVSS (25.0%, 95% CI: 5.5-57.2%). Of 4 men with arterial insufficiency observed on the PDU on ICI alone, 1 became normal after AVSS (25.0%, 95% CI: 0.6-80.6%). International Index of Erectile Function-5 scores were lower in patients with abnormal PDU (6.3 ± 3.3 vs 12.0 ± 5.8, p=0.003). On multivariable analysis, DM and International Index of Erectile Function-5 scores were the only independent predictors of abnormal PDU studies.
CLINICAL IMPLICATIONS


False diagnoses of venous leak during PDU with ICI could be a result of an increased adrenergic discharge during the examination. Routine AVSS may be helpful to avoid error in diagnosis.
STRENGTH & LIMITATIONS


The study has randomized the use of AVSS in different session orders. Only one previously published study has used this strategy to control the accommodation effect in repeat studies, a common source of bias in the PDU literature. The main limitation is the absence of a rigidity assessment and a redosing protocol.
CONCLUSION


Adding AVSS during PDU improves ICI response and may help clinicians evaluate penile hemodynamics more accurately. Carneiro F, Nascimento B, Miranda EP, et al. Audiovisual Sexual Stimulation Improves Diagnostic Accuracy of Penile Doppler Ultrasound in Patients With Erectile Dysfunction. J Sex Med 2020;17:249-256.",2020,EDV and RI were better in AVSS session (p = 0.022 and 0.019).,"['Patients With Erectile Dysfunction', 'Patients', 'A total of 40 men (mean age: 61.8 ± 10.2 years) with ED were enrolled']","['Penile Doppler Ultrasound', 'penile Doppler ultrasound (PDU', 'Audiovisual sexual stimulation (AVSS', 'AVSS', 'Audiovisual Sexual Stimulation', 'session A under intracavernous injection (ICI) alone and session B under ICI and AVSS']","['PSV, EDV, and RI values', 'PSV', 'adrenergic discharge', 'ICI response', 'International Index of Erectile Function-5 scores', 'EDV and RI', 'DM and International Index of Erectile Function-5 scores', 'Peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",12.0,0.0736946,EDV and RI were better in AVSS session (p = 0.022 and 0.019).,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Carneiro', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil. Electronic address: drcarneiro91@gmail.com.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Nascimento', 'Affiliation': 'Division of Urology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Eduardo P', 'Initials': 'EP', 'LastName': 'Miranda', 'Affiliation': 'Division of Urology, Federal University of Ceara, Ceara, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cury', 'Affiliation': 'Division of Urology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Giovanni G', 'Initials': 'GG', 'LastName': 'Cerri', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chammas', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.263']
3382,32027212,Patient Outcomes at Twelve Months after Early Decompressive Craniectomy for Diffuse Traumatic Brain Injury in the Randomized DECRA Clinical Trial.,"Functional outcomes at 12 months were a secondary outcome of the randomized DECRA trial of early decompressive craniectomy for severe diffuse traumatic brain injury (TBI) and refractory intracranial hypertension. In the DECRA trial, patients were randomly allocated 1:1 to either early decompressive craniectomy or intensive medical therapies (standard care). We conducted planned secondary analyses of the DECRA trial outcomes at 6 and 12 months, including all 155 patients. We measured functional outcome using the Glasgow Outcome Scale-Extended (GOS-E). We used ordered logistic regression, and dichotomized the GOS-E using logistic regression, to assess outcomes in patients overall and in survivors. We adjusted analyses for injury severity using the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) model. At 12 months, the odds ratio (OR) for worse functional outcomes in the craniectomy group (OR 1.68; 95% confidence interval [CI]: 0.96-2.93;  p  = 0.07) was no longer significant. Unfavorable functional outcomes after craniectomy were 11% higher (59% compared with 48%), but were not significantly different from standard care (OR 1.58; 95% CI: 0.84-2.99;  p  = 0.16). Among survivors after craniectomy, there were fewer good (OR 0.33; 95% CI: 0.12-0.91;  p  = 0.03) and more vegetative (OR 5.12; 95% CI: 1.04-25.2;  p  = 0.04) outcomes. Similar outcomes in survivors were found at 6 months after injury. Vegetative (OR 5.85; 95% CI: 1.21-28.30;  p  = 0.03) and severely disabled outcomes (OR 2.49; 95% CI: 1.21-5.11;  p  = 0.01) were increased. Twelve months after severe diffuse TBI and early refractory intracranial hypertension, decompressive craniectomy did not improve outcomes and increased vegetative survivors.",2020,Vegetative (OR 5.85; 95% CI 1.21 to 28.30; p=0.03) and severely disabled outcomes (OR 2.49; 95% CI 1.21 to 5.11; p=0.01) were increased.,['155 patients'],"['decompressive craniectomy', 'early decompressive craniectomy or intensive medical therapies (standard care']","['Unfavorable functional outcomes', 'severe diffuse traumatic brain injury and refractory intracranial hypertension', 'severely disabled outcomes', 'odds ratio (OR) for worse functional outcomes', 'extended Glasgow Outcomes Scale (GOS-E', 'vegetative survivors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2717817', 'cui_str': 'Decompressive Craniectomy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",155.0,0.166535,Vegetative (OR 5.85; 95% CI 1.21 to 28.30; p=0.03) and severely disabled outcomes (OR 2.49; 95% CI 1.21 to 5.11; p=0.01) were increased.,"[{'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Surgery, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Department of Intensive Care, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Davies', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Ponsford', 'Affiliation': 'School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Seppelt', 'Affiliation': 'Department of Intensive Care Medicine, Nepean Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Neurosurgery Department, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Wiegers', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurotrauma,['10.1089/neu.2019.6869']
3383,32087425,Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX).,"Clozapine is associated with obesity and type 2 diabetes. Glucagon-like-peptide-1 (GLP-1) receptor agonists such as exenatide can counter clozapine-associated GLP-1 dysregulation. Our 24-week randomized, controlled, open-label, pilot trial of once-weekly extended-release subcutaneous exenatide or usual care (CODEX) (n = 28), found exenatide was associated with significantly greater weight loss. We examined whether this effect was maintained at 12-months post-intervention. We followed up CODEX trial participants at 12-months post trial endpoint, collecting information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin. The primary outcome of interest was change in weight from trial baseline to 12-months post endpoint and trial endpoint to 12-months post endpoint compared between former exenatide and usual care participants. Only HbA1c differed between baseline and 12-months post endpoint between the exenatide and control groups. From endpoint to 12-month follow up there were significantly greater increases among the former exenatide versus former usual care participants for weight, BMI, HbA1c and proportion with >5% weight gain. Stratifying results by whether participants used metformin post trial did not alter proportion with >5% weight gain. Although there were no significant differences in weight and BMI between baseline and 12-month post endpoint, there were significant increases in weight and BMI in the 12 months post endpoint for the former exenatide group. This was irrespective of metformin use and is in keeping with studies of other GLP-1RA agents. Further studies on GLP-1RAs use beyond 24 weeks for people with clozapine associated weight gain are needed.",2020,"From endpoint to 12-month follow up there were significantly greater increases among the former exenatide versus former usual care participants for weight, BMI, HbA1c and proportion with >5% weight gain.",[],"['metformin', 'exenatide or usual care (CODEX', 'exenatide (CODEX', 'exenatide', 'clozapine', 'Clozapine']","['weight gain', 'weight loss', 'weight, BMI, HbA1c and proportion with >5% weight gain', 'weight and BMI', 'weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin']",[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",,0.0441752,"From endpoint to 12-month follow up there were significantly greater increases among the former exenatide versus former usual care participants for weight, BMI, HbA1c and proportion with >5% weight gain.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Siskind', 'Affiliation': 'Metro South Addiction and Mental Health Service, Brisbane, Australia; University of Queensland, School of Medicine, Brisbane, Australia. Electronic address: d.siskind@uq.edu.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'University of Queensland, School of Medicine, Brisbane, Australia; Princess Alexandra Hospital, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Metro South Addiction and Mental Health Service, Brisbane, Australia; Queensland Center for Mental Health Research Brisbane, Qld, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Queensland Center for Mental Health Research Brisbane, Qld, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cosgrove', 'Affiliation': 'Queensland Center for Mental Health Research Brisbane, Qld, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Burton', 'Affiliation': 'Queensland Center for Mental Health Research Brisbane, Qld, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kisely', 'Affiliation': 'Metro South Addiction and Mental Health Service, Brisbane, Australia; University of Queensland, School of Medicine, Brisbane, Australia.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.02.015']
3384,32077229,Comparison of two different minimally invasive percutaneous nephrostomy sheaths for the treatment of staghorn stones.,"OBJECTIVE


To compare the safety and effectiveness of using a conventional nephrostomy sheath (NS) vs using a new NS with suction and evacuation functions in minimally invasive percutaneous nephrolithotomy (MPCNL) for the treatment of staghorn stones.
PATIENTS AND METHODS


A prospective and randomised study of 60 patients with staghorn stones randomly assigned into two groups of 30 patients. One group underwent MPCNL using conventional NS, whereas the other group underwent MPCNL with suction-evacuation NS (SENS). Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results were collected and analysed.
RESULTS


The patient demographics and stone characteristics were similar amongst the two groups. The SENS group had a significantly lower peak and a significantly lower average renal pelvic pressure (RPP) throughout the procedure. The SENS group was more efficient for stone removal and had a much shorter stone treatment time, a lesser use of the stone extractor, and ultimately a higher stone-free rate (SFR). The effects of a lower RPP and shorter stone treatment time translated into less severe postoperative complications as measured per modified Clavien grade.
CONCLUSION


Using SENS in MPCNL for the treatment of staghorn stones has the advantages of lower RPP, increased effectiveness in stone retrieval, decreased surgery related complications, and an improved SFR.",2020,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","['Sixty patients with staghorn stones', 'staghorn stones']","['conventional nephrostomy sheath versus using a new access sheath with suction and evacuation functions', 'MPCNL with suction-evacuation nephrostomy sheaths (SENS', 'SENS', 'minimally invasive percutaneous nephrolithotomy (MPCNL', 'minimally invasive percutaneous nephrostomy sheaths', 'MPCNL using conventional nephrostomy sheaths (CNS']","['average renal pelvic pressure (RPP', 'Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results', 'patient demographics and stone characteristics', 'stone-free rate (SFR', 'safety and efficacy', 'shorter stone treatment time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332249', 'cui_str': 'Staghorn (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0564457', 'cui_str': 'Nephrostomy, Percutaneous'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0399825,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","[{'ForeName': 'Guibin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiezhao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}]",BJU international,['10.1111/bju.15031']
3385,32096120,Burst Suppression: Causes and Effects on Mortality in Critical Illness.,"BACKGROUND


Burst suppression in mechanically ventilated intensive care unit (ICU) patients is associated with increased mortality. However, the relative contributions of propofol use and critical illness itself to burst suppression; of burst suppression, propofol, and critical illness to mortality; and whether preventing burst suppression might reduce mortality, have not been quantified.
METHODS


The dataset contains 471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons. We used multiple prediction and causal inference methods to estimate the effects connecting burst suppression, propofol, critical illness, and in-hospital mortality in an observational retrospective study. We also estimated the effects mediated by burst suppression. Sensitivity analysis was used to assess for unmeasured confounding.
RESULTS


The expected outcomes in a ""counterfactual"" randomized controlled trial (cRCT) that assigned patients to mild versus severe illness are expected to show a difference in burst suppression burden of 39%, 95% CI [8-66]%, and in mortality of 35% [29-41]%. Assigning patients to maximal (100%) burst suppression burden is expected to increase mortality by 12% [7-17]% compared to 0% burden. Burst suppression mediates 10% [2-21]% of the effect of critical illness on mortality. A high cumulative propofol dose (1316 mg/kg) is expected to increase burst suppression burden by 6% [0.8-12]% compared to a low dose (284 mg/kg). Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
CONCLUSIONS


Our analysis clarifies how important factors contribute to mortality in ICU patients. Burst suppression appears to contribute to mortality but is primarily an effect of critical illness rather than iatrogenic use of propofol.",2020,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","['471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons', 'mechanically ventilated intensive care unit (ICU) patients', 'ICU patients']","['propofol', 'Propofol']","['burst suppression burden', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0609599,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Haoqi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aboul Nour', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabaeizadeh', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Maryum', 'Initials': 'M', 'LastName': 'Shoukat', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Javed', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Kassa', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Edhi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Bordbar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Valdery Moura', 'Initials': 'VM', 'LastName': 'Junior', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Ghanta', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'M Brandon', 'Initials': 'MB', 'LastName': 'Westover', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. mwestover@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-020-00932-4']
3386,31869451,"A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer.","BACKGROUND


The objective of the current study was to compare the safety and efficacy between 2 analgesic regimens for patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT).
METHODS


The current study was a prospective, single-institution, 2-arm, randomized pilot study. Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high-dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low-dose gabapentin (900 mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction.
RESULTS


A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; P = .002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
CONCLUSIONS


High-dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short-acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.",2020,"Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
","['patients undergoing chemoradiation for head and neck squamous cell cancer', '60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017', 'patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT', 'Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT']","['acetaminophen', 'gabapentin', 'institutional standard of care (hydrocodone', 'gabapentin and methadone', 'methadone', 'Methadone']","['QOL', 'Pain', 'safety and toxicity', 'physical functioning', 'adverse events or serious adverse events', 'pain, opioid requirement, and quality of life (QOL', 'QOL outcomes', 'social functioning', 'safety and efficacy', 'overall health', 'pain', 'role functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.0778271,"Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
","[{'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Hermann', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Austin J', 'Initials': 'AJ', 'LastName': 'Iovoli', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Alexis J', 'Initials': 'AJ', 'LastName': 'Platek', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Attwood', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",Cancer,['10.1002/cncr.32676']
3387,31380409,"Methods, system errors, and demographic differences in participant errors using daily text message-based short message service computer-assisted self-interview (SMS-CASI) to measure sexual risk behavior in a RCT of HIV self-test use.","Background


Assessment of sexual risk behavior is crucial to HIV prevention trials. Currently, there are no biomarkers or objective measures to detect and characterize sexual risk behavior; therefore, we must rely on self-reports. Self-report accuracy may be improved by collecting data in real-time. Our objective was to demonstrate how a text message-based short message service computer-assisted self-interview (SMS-CASI) system can collect daily sexual risk behavior data.
Methods


During the course of a 2-arm randomized controlled trial, confidential daily SMS-CASI was used to assess sexual risk behavior over three months for participants using only condoms in the control condition and using condoms and HIV self-tests to test themselves and their non-monogamous sexual partner over six months for participants in the intervention condition (total N=272). Active monitoring of participants responses and data cleaning took place concurrently with trial execution. Descriptive statistics were used to examine frequencies related to system functionality, participant reporting, system errors, communication patterns, and overall feasibility of using the SMS-CASI system for reporting sexual risk behavior.
Results


The SMS-CASI system processed 272,565 messages. In addition, 87 classifications of metadata were collected, for a total of 22,895,460 different data points. Types of messages included these sent (N=171,749; 63.01%) to participants, received (N=100,646; 36.93%) from participants, and failed (N=168; 0.06%) to be sent. Most errors (N=1,858) were due to system malfunctions (N=535; 28.79%) or participants' mistakes (N=1,289; 69.38%). Participant errors included: wrong password, incomplete surveys, and invalid response. The highest error rates by demographic characteristics were by age among older participants [ages 30-39; 383 errors (29.71%), and 40-69; 545 errors (42.28%)] and by race among Hispanic/Latino participants [487 errors (37.78%)].
Conclusions


The SMS-CASI system was effective at confidentially collecting sexual risk behavior data on a daily basis, potentially contributing to reduced recall and social desirability bias. This study provides methodological examples and data demonstrating how SMS-CASI can be used for sexual health data collection.",2019,"Types of messages included these sent (N=171,749; 63.01%) to participants, received (N=100,646; 36.93%) from participants, and failed (N=168; 0.06%) to be sent.","['participants using only condoms in the control condition and using condoms and HIV self-tests to test themselves and their non-monogamous sexual partner over six months for participants in the intervention condition (total N=272', 'older participants [ages 30-39; 383 errors (29.71%), and 40-69; 545 errors (42.28%)] and by race among Hispanic/Latino participants [487 errors (37.78']",['confidential daily SMS-CASI'],"['sexual risk behavior', 'participant errors using daily text message-based short message service computer-assisted self-interview (SMS-CASI) to measure sexual risk behavior']","[{'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178909'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",545.0,0.0408023,"Types of messages included these sent (N=171,749; 63.01%) to participants, received (N=100,646; 36.93%) from participants, and failed (N=168; 0.06%) to be sent.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, New York, NY, USA.'}]",mHealth,['10.21037/mhealth.2019.06.01']
3388,31876900,Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


The dupilumab regimen of 300 mg every 2 weeks is approved for uncontrolled, moderate to severe atopic dermatitis (AD).
Objective


To assess the efficacy and safety of different dupilumab regimens in maintaining response after 16 weeks of initial treatment.
Design, Setting, and Participants


The Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan. Patients with moderate to severe AD who received dupilumab treatment and achieved an Investigator's Global Assessment score of 0 or 1 or 75% improvement in Eczema Area and Severity Index scores (EASI-75) at week 16 in 2 previous dupilumab monotherapy trials (LIBERTY AD SOLO 1 and 2) were rerandomized in SOLO-CONTINUE. After completing SOLO-CONTINUE, patients were followed up for up to 12 weeks or enrolled in an open-label extension. Data were analyzed from December 5 to 12, 2016.
Interventions


High-responding patients treated with dupilumab in SOLO were rerandomized 2:1:1:1 to continue their original regimen of dupilumab, 300 mg, weekly or every 2 weeks or to receive dupilumab, 300 mg, every 4 or 8 weeks or placebo for 36 weeks.
Main Outcomes and Measures


Percentage change in EASI score from baseline during the SOLO-CONTINUE trial, percentage of patients with EASI-75 at week 36, and safety.
Results


Among the 422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male), continuing dupilumab treatment once weekly or every 2 weeks maintained optimal efficacy, with negligible change in percent EASI improvement from SOLO 1 and 2 baseline during the SOLO-CONTINUE trial (-0.06%; P < .001 vs placebo); percent change with the other regimens dose-dependently worsened (dupilumab every 4 weeks, -3.84%; dupilumab every 8 weeks, -6.84%; placebo, -21.67%). More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]). Overall adverse event incidences were 70.7% in the weekly or every 2 weeks group, 73.6% in the every 4 weeks group, 75.0% in the every 8 weeks group, and 81.7% in the placebo group. Treatment groups had similar conjunctivitis rates. Treatment-emergent antidrug antibody incidence was lower with more frequent dupilumab dose regimens (11.3% in the placebo group and 11.7%, 6.0%, 4.3%, and 1.2% in the dupilumab every 8 weeks, every 4 weeks, every 2 weeks, and weekly groups, respectively).
Conclusions and Relevance


In this trial, continued response over time was most consistently maintained with dupilumab administered weekly or every 2 weeks. Longer dosage intervals and placebo resulted in a diminution of response for both continuous and categorical end points. No new safety signals were observed. The approved regimen of 300 mg of dupilumab every 2 weeks is recommended for long-term treatment.
Trial Registration


ClinicalTrials.gov identifier: NCT02395133.",2020,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"['Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan', '422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male', 'uncontrolled, moderate to severe atopic dermatitis (AD', 'Patients with moderate to severe AD', 'Patients With Atopic Dermatitis', 'Interventions\n\n\nHigh-responding patients treated with dupilumab in SOLO']","['placebo', 'dupilumab regimens', 'dupilumab', 'Multiple Dupilumab Dose Regimens']","['efficacy and safety', 'Overall adverse event incidences', 'EASI-75 response', 'Eczema Area and Severity Index scores (EASI-75', 'conjunctivitis rates', 'Efficacy and Safety', 'EASI score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",422.0,0.348949,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"[{'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, Nice University Hospital, Nice, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Klinik und Poliklinik für Dermatologie, Universitätsklinikum, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrándiz', 'Affiliation': 'Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Universidad Autónoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guys and St Thomas' Foundation Trust, King's College, London, United Kingdom.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3617']
3389,31493728,A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.,"Anticoagulation in children is problematic for multiple reasons. Currently used anticoagulants have significant disadvantages and may negatively affect quality of life (QOL). This manuscript describes the design, rationale, and methods of a prospective, randomized, open label phase II multi-national clinical trial of a direct oral anticoagulant (DOAC), apixaban, in children and infants with congenital and acquired heart disease. This trial is designed to gather preliminary safety and pharmacokinetics (PK) data, as well as generate data on QOL of individuals taking apixaban compared to the standard of care (SOC) anticoagulants vitamin K antagonists (VKA) or low molecular weight heparin (LMWH). A key issue this trial seeks to address is the practice of using therapeutics tested in adult trials in the pediatric population without robust pediatric safety or efficacy data. Pediatric heart diseases are not common, and specific diagnoses often meet the criteria of a rare disease; thus, statistical efficacy may be difficult to achieve. This trial will provide valuable PK and safety data intended to inform clinical practice for anticoagulation in pediatric heart diseases, a setting in which a fully powered phase III clinical trial is not feasible. A second consideration this trial addresses is that metrics besides efficacy, such as QOL, have not been traditionally used as endpoints in regulated anticoagulation studies yet may add substantial weight to the clinical decision for use of a DOAC in place of VKA or LMWH. This study examines QOL related to both heart disease and anticoagulation among children randomized to either SOC or apixaban. There are considerable strengths and benefits to conducting a clinical trial in pediatric rare disease populations via an industry-academic collaboration. The SAXOPHONE study represents a collaboration between Bristol-Myers Squibb (BMS)/Pfizer Alliance, and the National Heart, Lung, and Blood Institute's (NHLBI) Pediatric Heart Network (PHN) and may be an attractive model for future pediatric drug trials.",2019,"A second consideration this trial addresses is that metrics besides efficacy, such as QOL, have not been traditionally used as endpoints in regulated anticoagulation studies yet may add substantial weight to the clinical decision for use of a DOAC in place of VKA or LMWH.","['children and infants with congenital and acquired heart disease', 'children with cardiac disease']","['care (SOC) anticoagulants vitamin K antagonists (VKA) or low molecular weight heparin (LMWH', 'direct oral anticoagulant (DOAC), apixaban', 'ApiXaban', 'direct oral anticoagulant', 'SOC or apixaban']",['quality of life (QOL'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]",[{'cui': 'C0034380'}],,0.0918851,"A second consideration this trial addresses is that metrics besides efficacy, such as QOL, have not been traditionally used as endpoints in regulated anticoagulation studies yet may add substantial weight to the clinical decision for use of a DOAC in place of VKA or LMWH.","[{'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Riley Hospital for Children, Indiana Univ. School of Medicine, Indianapolis, IN 46202. Electronic address: rpayne@iu.edu.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burns', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD 20892.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Glatz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104.""}, {'ForeName': 'Danshi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Innovative Medicines Development, Bristol-Myers Squibb Co., Lawrenceville, NJ, 08648.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Innovative Medicines Development, Bristol-Myers Squibb Co., Lawrenceville, NJ, 08648.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monagle', 'Affiliation': ""Department of Pediatrics, Univ. of Melbourne, Royal Children's Hospital, Melbourne, Murdoch Children's Research Institute, Australia.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School, Boston, MA 02115.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Swan', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Riley Hospital for Children, Indiana Univ. School of Medicine, Indianapolis, IN 46202.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wheaton', 'Affiliation': 'HealthCore-NERI, Watertown, MA 02472.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Male', 'Affiliation': 'Department of Pediatrics, Medical Univ. of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2019.08.002']
3390,31330464,Alcohol demand moderates brief motivational intervention outcomes in underage young adult drinkers.,"INTRODUCTION


The Alcohol Purchase Task (APT), a behavioral economic measure of alcohol's reinforcing value (demand), has been used to predict the effects of Brief Motivational Intervention (BMI) on alcohol use outcomes. However, it is not known whether BMI may be more or less efficacious, relative to control, among those with different levels of alcohol demand prior to treatment.
METHODS


Non college-attending young adults (N = 150) reporting past-month heavy drinking were randomized to a single in-person session of BMI or a relaxation training control (REL). The BMI included delivery of personalized feedback and focused on developing discrepancy between the young adults' goals and their current pattern of alcohol use. At baseline, participants completed assessments of alcohol use and the APT. Drinking levels were re-assessed at 6 weeks and 3 months post-intervention. Demand indices derived from the APT were examined as moderators of treatment effects on follow-up drinking after covarying for baseline alcohol use.
RESULTS


Two of four APT demand indices - intensity and O max  - moderated treatment outcomes. Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand. This association was not observed among participants with lower levels of alcohol demand.
CONCLUSIONS


These results demonstrate that BMI may be particularly beneficial for those with a high reinforcing value of alcohol. The mechanism for this effect is unclear, and determining the process by which BMI confers increased benefit for these individuals is a fruitful area for future work.",2019,"Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand.","['underage young adult drinkers', 'participants with lower levels of alcohol demand', 'Non college-attending young adults (N\u202f=\u202f150) reporting past-month heavy drinking']","['single in-person session of BMI or a relaxation training control (REL', 'Alcohol demand moderates brief motivational intervention', 'Brief Motivational Intervention (BMI']","['indices - intensity and O max', 'Drinking levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.013402,"Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand.","[{'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Cassidy', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States. Electronic address: Rachel_Cassidy@Brown.edu.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bernstein', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': ""Peter Boris Centre for Addictions Research, McMaster University & St. Joseph's Healthcare Hamilton, United States.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, University of Memphis, United States.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106044']
3391,32164679,Bouldering psychotherapy is more effective in the treatment of depression than physical exercise alone: results of a multicentre randomised controlled intervention study.,"BACKGROUND


Recent scientific studies have suggested that climbing/bouldering is effective in alleviating depression when the comparison group was a waitlist control group, even when physical activity and other therapeutic approaches were controlled for. In the present study, we aimed to investigate the effectiveness of a manualised psychotherapeutic bouldering intervention for depressed individuals, compared with an active control group performing physical exercise alone.
METHODS


In a multicentre randomised controlled intervention trial, 133 outpatients with depression were assigned to either a bouldering psychotherapy (BPT) group or a home-based supervised exercise programme (EP). Severity of depression as the primary outcome was assessed at baseline and directly after a ten-week intervention period using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included anxiety, coping skills, self-esteem, body image, and interpersonal sensitivity. We applied t-tests to test for differences within the groups (t0 vs. t1) and between the BPT and the EP and a multiple regression analysis with the post-intervention MADRS score as the dependent variable. The robustness of estimates was investigated with a sensitivity analyses.
RESULTS


Patients in the BPT group showed a significantly larger decrease in depression scores compared with the EP on the MADRS (drop of 8.4 vs. 3.0 points, p = .002, Cohen's d = 0.55). In the confounder-adjusted regression analyses, group allocation was found to be the only significant predictor of the post-intervention MADRS score (β = - 5.60, p = .001) besides the baseline MADRS score. Further significant differences in change scores between the BPT and the EP were found for anxiety (p = .046, d = 0.35), body image (p = .018, d = 0.42), and global self-esteem (p = .011, d = 0.45).
CONCLUSIONS


The study provides evidence that the manualised BPT is not only effective in alleviating depressive symptoms but even goes beyond the effect of mere physical exercise. Based on these findings, the BPT should be considered as a complementary therapeutic approach.
TRIAL REGISTRATION


Trial identification number: ISRCTN12457760: Study KuS (Klettern und Stimmung - Climbing and Mood) combined boulder and psychotherapy against depression, registered retrospectively on July 26th, 2017.",2020,"Further significant differences in change scores between the BPT and the EP were found for anxiety (p = .046, d = 0.35), body image (p = .018, d = 0.42), and global self-esteem (p = .011, d = 0.45).
",['133 outpatients with depression'],"['bouldering psychotherapy (BPT) group or a home-based supervised exercise programme (EP', 'BPT', 'active control group performing physical exercise alone', 'manualised psychotherapeutic bouldering intervention']","['Montgomery-Åsberg Depression Rating Scale (MADRS', 'baseline MADRS score', 'anxiety', 'MADRS', 'depression scores', 'global self-esteem', 'anxiety, coping skills, self-esteem, body image, and interpersonal sensitivity', 'change scores', 'post-intervention MADRS score']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",133.0,0.07352,"Further significant differences in change scores between the BPT and the EP were found for anxiety (p = .046, d = 0.35), body image (p = .018, d = 0.42), and global self-esteem (p = .011, d = 0.45).
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Karg', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany. nina.karg@uk-erlangen.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dorscht', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kornhuber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Luttenberger', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02518-y']
3392,32036562,Polarity- and Intensity-Independent Modulation of Timing During Delay Eyeblink Conditioning Using Cerebellar Transcranial Direct Current Stimulation.,"Delay eyeblink conditioning (dEBC) is widely used to assess cerebellar-dependent associative motor learning, including precise timing processes. Transcranial direct current stimulation (tDCS), noninvasive brain stimulation used to indirectly excite and inhibit select brain regions, may be a promising tool for understanding how functional integrity of the cerebellum influences dEBC behavior. The aim of this study was to assess whether tDCS-induced inhibition (cathodal) and excitation (anodal) of the cerebellum differentially impact timing of dEBC. A standard 10-block dEBC paradigm was administered to 102 healthy participants. Participants were randomized to stimulation conditions in a double-blind, between-subjects sham-controlled design. Participants received 20-min active (anodal or cathodal) stimulation at 1.5 mA (n = 20 anodal, n = 22 cathodal) or 2 mA (n = 19 anodal, n = 21 cathodal) or sham stimulation (n = 20) concurrently with dEBC training. Stimulation intensity and polarity effects on percent conditioned responses (CRs) and CR peak and onset latency were examined using repeated-measures analyses of variance. Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups. CR peak and onset latencies were later, i.e., closer to air puff onset, in all active stimulation groups compared to the sham group. Thus, tDCS facilitated cerebellar-dependent timing of dEBC, irrespective of stimulation intensity and polarity. These findings highlight the feasibility of using tDCS to modify cerebellar-dependent functions and provide further support for cerebellar contributions to human eyeblink conditioning and for exploring therapeutic tDCS interventions for cerebellar dysfunction.",2020,Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups.,['102 healthy participants'],"['Transcranial direct current stimulation (tDCS), noninvasive brain stimulation', 'tDCS-induced inhibition (cathodal) and excitation (anodal', '20-min active (anodal or cathodal) stimulation at 1.5\xa0mA (n\u2009=\u200920 anodal, n\u2009=\u200922 cathodal) or 2\xa0mA (n\u2009=\u200919 anodal, n\u2009=\u200921 cathodal) or sham stimulation (n\u2009=\u200920) concurrently with dEBC training', 'dEBC', 'Delay eyeblink conditioning (dEBC']","['Acquisition of CRs', 'percent conditioned responses (CRs) and CR peak and onset latency', 'Polarity- and Intensity-Independent Modulation of Timing', 'CR peak and onset latencies']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034936', 'cui_str': 'Conditioned Reflex'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}]",102.0,0.155311,Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mitroi', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Leah P', 'Initials': 'LP', 'LastName': 'Burroughs', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Moussa-Tooks', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Bolbecker', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Hetrick', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA. whetrick@indiana.edu.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01114-w']
3393,31078564,Randomized comparison of two web-based interventions on immediate and 30-day opioid overdose knowledge in three unique risk groups.,"BACKGROUND


In response to the opioid overdose epidemic, scalable interventions that instruct at-risk populations how to prevent and respond to overdose scenarios are needed.
METHOD


The following groups of at-risk individuals were recruited online: (1) Acute Pain patients with an opioid prescription, (2) Chronic Pain patients with an opioid prescription, and (3) persons without pain who use Illicit Opioids. Participants were tested on their opioid overdose knowledge using the Brief Opioid Overdose Knowledge (BOOK) questionnaire and randomized to one of two web-based interventions that contained 25 educational content slides. One intervention consisted of embedded questions with corrective feedback (Presentation + Mastery, n = 58), the other did not (Presentation, n = 61). Participants completed the BOOK again at the end of the intervention and 30 days later. Overdose risk behaviors were assessed at baseline and 30-days.
RESULTS


Relative to baseline, both Presentation and Presentation + Mastery interventions increased total BOOK scores immediately and 30 days later. There was a significant effect of Group on BOOK Knowledge, whereby those with Acute Pain had lower scores across time, regardless of intervention, relative to those with Chronic Pain and Illicit Opioid Use. Compared to baseline, all three groups reported fewer instances of using opioids alone or concurrently with alcohol at the 30-day follow-up.
CONCLUSIONS


A web-based intervention increased opioid overdose knowledge and decreased overdose risk behavior immediately and at a one-month follow-up, suggesting that this brief, practical, and scalable program could have utility in several populations who are at-risk of opioid overdose.",2019,"There was a significant effect of Group on BOOK Knowledge, whereby those with Acute Pain had lower scores across time, regardless of intervention, relative to those with Chronic Pain and Illicit Opioid Use.","['three unique risk groups', 'Participants were tested on their opioid overdose knowledge using the Brief Opioid Overdose Knowledge (BOOK) questionnaire and randomized to one of two web-based interventions that contained 25 educational content slides', 'groups of at-risk individuals were recruited online', '1) Acute Pain patients with an opioid prescription, (2) Chronic Pain patients with an opioid prescription, and (3) persons without pain who use Illicit Opioids']",[],"['opioid overdose knowledge and decreased overdose risk behavior', 'Presentation and Presentation + Mastery', 'total BOOK scores', 'Overdose risk behaviors']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}]",[],"[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",2.0,0.0267,"There was a significant effect of Group on BOOK Knowledge, whereby those with Acute Pain had lower scores across time, regardless of intervention, relative to those with Chronic Pain and Illicit Opioid Use.","[{'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Huhn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America. Electronic address: kdunn9@jhmi.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2019.05.006']
3394,32030356,"Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).","Background:   Chlamydia trachomatis ,  Neisseria gonorrhoeae ,  Trichomonas vaginalis  and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight.  Methods : The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI 'syndromic' management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care.  Conclusions:  WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide.  Registration:  ISRCTN37134032.",2019,"WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings.","['high-burden, low-income settings', 'pregnant women in many low- and middle-income settings']",['standard antenatal care'],"['effectiveness, cost-effectiveness, acceptability and health system requirements', 'composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight', 'cost-effectiveness, acceptability and health system requirements']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}]",,0.182314,"WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vallely', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Pomat', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Homer', 'Affiliation': 'Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Guy', 'Affiliation': 'The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Glen D L', 'Initials': 'GDL', 'LastName': 'Mola', 'Affiliation': 'School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, NCD, Papua New Guinea.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kariwiga', 'Affiliation': 'Milne Bay Provincial Health Authority, Alotau, MBP, Papua New Guinea.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Vallely', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wiseman', 'Affiliation': 'The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rogerson', 'Affiliation': 'Doherty Institute, Department of Medicine, University of Melbourne, Melbourne, VIC, 3050, Australia.'}, {'ForeName': 'Sepehr N', 'Initials': 'SN', 'LastName': 'Tabrizi', 'Affiliation': ""Department of Microbiology, The Royal Women's Hospital Melbourne, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Whiley', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Herston, QLD, 4029, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Low', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, 3012, Switzerland.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Peeling', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, WC1E 7HT, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Siba', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Riddell', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Laman', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bolnga', 'Affiliation': 'Department of Obstetrics & Gynaecology, Modilon General Hospital, Madang, MP, Papua New Guinea.'}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Robinson', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Morewaya', 'Affiliation': 'Milne Bay Provincial Health Authority, Alotau, MBP, Papua New Guinea.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Badman', 'Affiliation': 'The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Batura', 'Affiliation': 'Centre for Global Health Economics, Institute for Global Health, University College London, London, WC1N 1EH, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kelly-Hanku', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Toliman', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Peter', 'Affiliation': 'Provincial Health Office, Madang, MP, Papua New Guinea.'}, {'ForeName': 'Delly', 'Initials': 'D', 'LastName': 'Babona', 'Affiliation': ""St Mary's Vunapope Rural Hospital, Kokopo, ENBP, 613, Papua New Guinea.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Peach', 'Affiliation': 'Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Department of Microbiology, The Royal Women's Hospital Melbourne, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.'}]",Wellcome open research,['10.12688/wellcomeopenres.15173.2']
3395,30973053,Glasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe Traumatic Brain Injury.,"The original unstructured Glasgow Outcome Scale (uGOS) and the newer structured interviews GOS and the Extended GOS (GOS-E) have been used widely as outcomes in severe traumatic brain injury (TBI) trials. We compared outcome categories (ranging from dead [D] to good recovery [GR]) for each measure in a randomized trial of transfusion threshold and the implications of measure choice and analysis methods for the results of the trial. We planned to explore patient symptomology possibly driving any discrepancies between the patient's uGOS and GOS scores. Category correspondence between uGOS and GOS scores occurred in 160 (88.4%) of the 181 analyzed cases. The GOS-E and GOS instruments incorporated more behavioral/cognitive/social and other components, leading to a worse outcome in some cases than for the uGOS. Choice of outcome measure and analysis led to incongruous conclusions. Dichotomizing uGOS into favorable outcome (GR and moderate disability [MD] categories) versus unfavorable (severe disability [SD], vegetative state [VS], and D categories), we observed a significant effect of transfusion threshold (odds ratio [OR] = 0.51,  p  = 0.03; adjusted OR = 0.40,  p  = 0.02). For the same dichotomization of GOS and GOS-E, the effect was not statistically significant but the ORs were similar (ORs between 0.57 and 0.68,  p  > 0.15 for all). An effect was not detected using ordinal logistic regression or sliding dichotomy method for all three measures. Differences in categorizations of subjects between moderate and severe disability among the scales impacted conclusions of the trial. In future studies, particular attention should be given to implementing GOS measures and describing the methodology for how outcomes were ascertained.",2019,"For the same dichotomization of GOS and GOS-E, the effect was not statistically significant but the ORs were similar (ORs between 0.57 and 0.68,  p  > 0.15 for all).",[],[],"['Severe Traumatic Brain Injury', 'Dichotomizing uGOS into favorable outcome (GR and moderate disability [MD] categories) versus unfavorable (severe disability [SD], vegetative state [VS], and D categories', 'Category correspondence between uGOS and GOS scores']",[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0917808', 'cui_str': 'Vegetative State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0861415,"For the same dichotomization of GOS and GOS-E, the effect was not statistically significant but the ORs were similar (ORs between 0.57 and 0.68,  p  > 0.15 for all).","[{'ForeName': 'Jose-Miguel', 'Initials': 'JM', 'LastName': 'Yamal', 'Affiliation': 'Coordinating Center for Clinical Trials, Department of Biostatistics and Data Science, The University of Texas School of Public Health, Houston, Texas.'}, {'ForeName': 'H Julia', 'Initials': 'HJ', 'LastName': 'Hannay', 'Affiliation': 'Department of Psychology, University of Houston, Houston, Texas.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Gopinath', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Imoigele P', 'Initials': 'IP', 'LastName': 'Aisiku', 'Affiliation': ""Harvard Medical School/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Benoit', 'Affiliation': 'Texas Institute for Measurement Evaluation and Statistics (TIMES), University of Houston, Houston, Texas.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Robertson', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}]",Journal of neurotrauma,['10.1089/neu.2018.5939']
3396,31678945,Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.,"INTRODUCTION


Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.
METHODS AND ANALYSIS


A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.
ETHICS AND DISSEMINATION


Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2 nd  July 2018.
TRIAL REGISTRATION NUMBER


ISRCTN16612336.",2019,"Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group.","['48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK', 'adults aged 50 years and over after ankle fracture', 'adults, with prognosis worsening with increasing age', 'adults aged 50 years or over after ankle fracture']","['Progressive functional exercise versus best practice advice', 'central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy', 'progressive functional exercise']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.164832,"Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Barber', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Redmond', 'Affiliation': 'Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030877']
3397,31228054,Impact of Social Needs Navigation on Utilization Among High Utilizers in a Large Integrated Health System: a Quasi-experimental Study.,"BACKGROUND


Programs addressing social determinants of health for high-utilizing patients are gaining interest among health systems as an avenue to promote health and decrease utilization.
OBJECTIVE


To evaluate impacts of a social needs screening and navigation program for adult predicted high utilizers on total medical visit utilization.
DESIGN


A prospective, quasi-experimental study using an intent-to-treat propensity-weighted difference-in-differences approach. Stratified analyses assessed intervention effects among three low-socioeconomic status sub-samples: patients in low-income areas, in low-education areas, and with Medicaid insurance.
PARTICIPANTS


Predicted high utilizers-patients predicted to be in the highest 1% for total utilization in a large integrated health system.
INTERVENTION


A telephonic social needs screening and navigation program.
MAIN MEASURES


Primary difference-in-difference analyses compared total visit count utilization, including outpatient, emergency department (ED), and inpatient utilization, between the intervention and control groups at both in-network and out-of-network facilities. Prevalence of social needs among sample patients and their connection rates to social needs resources are also described.
KEY RESULTS


The study included 34,225 patients (7107 intervention, 27,118 control). Most (53%) patients screened reported social needs, but only a minority (10%) of those with a need were able to connect with resources to address these needs. Primary analysis found total utilization visits decreased 2.2% (95% CI - 4.5%, 0.1%; p = 0.058) in the intervention group. Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
CONCLUSIONS


Social needs navigation programs for high-utilizing patients may have modest effects on utilization for the population overall. However, significant decreases in utilization were found among low-socioeconomic status patients more likely to experience social needs.",2019,"Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
","['Predicted high utilizers-patients predicted to be in the highest 1% for total utilization in a large integrated health system', 'three low-socioeconomic status sub-samples: patients in low-income areas, in low-education areas, and with Medicaid insurance', '34,225 patients (7107 intervention, 27,118 control']","['social needs screening and navigation program', 'Social Needs Navigation']","['Utilization', 'utilization', 'total visit count utilization, including outpatient, emergency department (ED), and inpatient utilization', 'total utilization visits', 'total utilization']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]",34225.0,0.0268934,"Stratified analyses showed decreases in total utilization for all low-socioeconomic status subgroups receiving the intervention compared with controls: - 7.0% (95% CI - 11.9%, - 1.9%; p = 0.008) in the low-income area group, - 11.5% (- 17.6%, 5.0%; p < 0.001) in the low-education area group, and - 12.1% (- 18.1%, - 5.6%; p < 0.001) in the Medicaid group.
","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Schickedanz', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine at UCLA, 10960 Wilshire Blvd., Suite 960, Los Angeles, CA, 90024, USA. Aschickedanz@mednet.ucla.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Yi R', 'Initials': 'YR', 'LastName': 'Hu', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Nirav R', 'Initials': 'NR', 'LastName': 'Shah', 'Affiliation': 'Stanford University Clinical Excellence Research Center, Stanford, CA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Adams', 'Affiliation': 'Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Francis', 'Affiliation': 'Health Leads, Boston, MA, USA.'}, {'ForeName': 'Artair', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Health Leads, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05123-2']
3398,31798291,Prevention in Prison: The Diabetes Prevention Program in a Correctional Setting.,"Purpose


The purpose of this study was to determine whether an adaptation of the Diabetes Prevention Program (DPP) could be successfully implemented in a correctional environment to promote weight loss, lower A1C, and improve other cardiometabolic outcomes.
Methods


A quasi-experimental, staggered-start control study was conducted in a female and male federal correctional institution. Twenty-six male and 21 female incarcerated, overweight individuals with prediabetes or at high risk for developing diabetes were randomly assigned to two groups. Data were measured at 6-month intervals starting at baseline for 18 months. Group 1 participated in the 12-month Group Lifestyle Balance intervention program from baseline to 12 months. Group 2 served as a control group from baseline for 6 months and then completed the intervention program from months 6 to 18.
Results


Participants were ethnically diverse and mostly >44 years of age. At baseline, members of the two study groups were not significantly different with regard to sex, race/ethnicity, age, or prediabetes status. About half of participants (51%) completed the program, with participants in group 1 significantly more likely to be completers ( P  <0.05). At 6 months, participants in the intervention group had significantly more weight loss on average (12 lb) than those in the control/delayed-start group (5 lb) ( P  <0.001). However, both groups (active intervention and control) experienced significant decreases in weight, BMI, triglycerides, and A1C levels after 6 months. In combined analysis, after the 12-month intervention, participants in both groups demonstrated significant decreases in BMI ( P  <0.001) and A1C ( P  <0.001) from baseline.
Conclusion


The DPP may be an effective method for reducing the impact of diabetes in the correctional environment addressed. Larger studies should be conducted to confirm these outcomes. Study findings were affected by high attrition rates, primarily due to transfers and releases from the institution.",2019,"At baseline, members of the two study groups were not significantly different with regard to sex, race/ethnicity, age, or prediabetes status.","['Twenty-six male and 21 female incarcerated, overweight individuals with prediabetes or at high risk for developing diabetes', 'Prison', 'female and male federal correctional institution', 'Results\n\n\nParticipants were ethnically diverse and mostly >44 years of age']","['Lifestyle Balance intervention program', 'Diabetes Prevention Program (DPP']","['weight, BMI, triglycerides, and A1C levels', 'weight loss', 'BMI']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",26.0,0.0270591,"At baseline, members of the two study groups were not significantly different with regard to sex, race/ethnicity, age, or prediabetes status.","[{'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Fine', 'Affiliation': 'Wellness and Diabetes Program, Cowlitz Indian Tribe, Longview, WA.'}, {'ForeName': 'M Shayne', 'Initials': 'MS', 'LastName': 'Gallaway', 'Affiliation': 'U.S. Department of Health and Human Services, U.S. Public Health Service Commissioned Corps, Washington, DC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dukate', 'Affiliation': 'Federal Correctional Institution of the Federal Bureau of Prisons, Danbury, CT.'}]",Diabetes spectrum : a publication of the American Diabetes Association,['10.2337/ds18-0080']
3399,31621838,Antiretroviral Therapy-Induced Bone Loss Is Durably Suppressed by a Single Dose of Zoledronic Acid in Treatment-Naive Persons with Human Immunodeficiency Virus Infection: A Phase IIB Trial.,"BACKGROUND


Human immunodeficiency virus (HIV) infection and antiretroviral therapy (ART) are associated with bone loss leading to increased fracture rate among persons with HIV (PWH). We previously showed long-acting antiresorptive zoledronic acid (ZOL) prevented ART-induced bone loss through 48 weeks of therapy and here investigate whether protection persisted.
METHODS


We randomized 63 nonosteoporotic, treatment-naive adult PWH initiating ART to ZOL (5 mg) versus placebo in a double-blinded, placebo-controlled, phase IIb trial. Here we analyzed the long-term outcome data (144 weeks). Plasma bone turnover markers and bone mineral density (BMD) were quantified at weeks 0, 12, 24, 48, 96, and 144. Primary outcome was change in bone resorption marker C-terminal telopeptide of collagen (CTx). Repeated-measures analyses using mixed linear models were used to estimate and compare study endpoints.
RESULTS


At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n = 46; CTx = 0.123 vs 0.324 ng/mL; P < .001); at 144 weeks a 25% difference between arms was not statistically significant. At 48 weeks, lumbar spine BMD with ZOL was 11% higher than placebo (n = 60; P < .001) and remained 9-11% higher at 96 (n = 46) and 144 (n = 41; P < .001) weeks. 144 weeks after ZOL infusion, BMD did not change at the lumbar spine (P = .22) but declined at the hip (P = .04) and femoral neck (P = .02).
CONCLUSIONS


A single dose of ZOL administered at ART initiation blunts bone resorption and BMD loss at key fracture-prone anatomical sites in treatment-naive PWH for 3 years. A multicenter randomized phase III clinical trial validating these results in a larger population is needed.
CLINICAL TRIALS REGISTRATION


NCT01228318.",2020,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.",['persons with HIV (PWH'],"['antiresorptive zoledronic acid (ZOL', 'ZOL', 'placebo', 'Zoledronic Acid', 'antiretroviral therapy (ART']","['Plasma bone turnover markers and bone mineral density (BMD', 'lumbar spine BMD', 'mean CTx', 'femoral neck', 'lumbar spine', 'bone resorption and BMD loss', 'bone resorption marker C-terminal telopeptide of collagen (CTx']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]",63.0,0.676076,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.","[{'ForeName': 'Ighovwerha', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Collins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Kehmia', 'Initials': 'K', 'LastName': 'Titanji', 'Affiliation': 'Division of Endocrinology and Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Foster', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Caitlin A', 'Initials': 'CA', 'LastName': 'Moran', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Anandi N', 'Initials': 'AN', 'LastName': 'Sheth', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Cecile D', 'Initials': 'CD', 'LastName': 'Lahiri', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Lennox', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ward', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Easley', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'M Neale', 'Initials': 'MN', 'LastName': 'Weitzmann', 'Affiliation': 'Division of Endocrinology and Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1027']
3400,31564599,"Cluster Randomized Trial of Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas.","INTRODUCTION


This study examines smoke-free youth partnerships implementing the Teens Against Tobacco Use model developed by the American Lung Association. This innovative tobacco prevention strategy has not been evaluated rigorously. Students used peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities. Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools.
STUDY DESIGN


To evaluate the efficacy of the presentations, matched pairs of classrooms willing to have 1 presentation were randomly assigned to receive either the presentation first (intervention condition) or later in the school year (control condition).
SETTING/PARTICIPANTS


The study took place in a predominantly low-income Hispanic community. A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation.
MAIN OUTCOME MEASURES


Tobacco susceptibility was assessed with a brief survey administered to students in both intervention and control classrooms in 2014 and 2015 after the completion of presentations in intervention classrooms. Analyses completed in 2019 compared intervention and control classrooms on tobacco susceptibility.
RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility. Teens Against Tobacco Use presenters also completed tobacco retailer compliance checks and gained media coverage in advocating to regulate e-cigarettes in the same manner as other tobacco products.
CONCLUSIONS


Findings suggest Teens Against Tobacco Use is an effective means of reducing tobacco susceptibility among 4th-8th graders in the immediate term. Longer-term outcome evaluations are needed to determine whether Teens Against Tobacco Use presentations can have a lasting impact on tobacco use.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02443025.",2019,"RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","['matched pairs of classrooms willing to have 1 presentation', 'A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation', 'Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas', 'Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools', 'predominantly low-income Hispanic community']","['presentation first (intervention condition) or later in the school year (control condition', 'peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities']","['tobacco susceptibility scores', 'tobacco susceptibility']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",107.0,0.0425585,"RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","[{'ForeName': 'Louis D', 'Initials': 'LD', 'LastName': 'Brown', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston, School of Public Health, El Paso, Texas. Electronic address: louis.d.brown@uth.tmc.edu.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Bandiera', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Department of Epidemiology, Human Genetics, and Environmental Sciences, University of Texas Health Science Center at Houston, School of Public Health, Austin, Texas.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.013']
3401,31310775,"Intravenous administration of ghrelin increases serum cortisol and aldosterone concentrations in heavy-drinking alcohol-dependent individuals: Results from a double-blind, placebo-controlled human laboratory study.","Increasing evidence supports the role of appetite-regulating hormones, including ghrelin, in alcohol use disorder (AUD). Effects of ghrelin administration on cortisol and aldosterone, two hormones known to influence the development and maintenance of AUD, have been observed in ghrelin-exposed tissues or cells, as well as rodents and healthy volunteers, however whether these effects replicate in individuals with AUD is unknown. Here, we tested the hypothesis that intravenous administration of ghrelin leads to increase in endogenous serum cortisol and aldosterone concentrations in alcohol-dependent, heavy drinking individuals, and that these changes may predict ghrelin-induced alcohol craving. This was a double-blind, placebo-controlled human laboratory study in non-treatment-seeking, heavy-drinking, alcohol-dependent individuals randomized to receive either placebo, 1 mcg/kg or 3 mcg/kg of intravenous ghrelin. Then, participants underwent a cue-reactivity procedure in a bar-like setting, which included exposure to both neutral (juice) and alcohol cues. Repeated blood samples were collected and used to measure endogenous cortisol and aldosterone serum concentrations, in response to exogenous ghrelin administration. Furthermore, cortisol and aldosterone serum concentrations were used to develop a model to predict the effect of exogenous ghrelin administration on alcohol craving. Intravenous ghrelin administration increased endogenous cortisol and aldosterone serum concentrations. While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving. These findings provide initial evidence of ghrelin effects on glucocorticoids and mineralocorticoids in individuals with AUD, thereby providing additional information on the potential mechanisms by which the ghrelin system may play a role in alcohol craving and seeking in AUD.",2019,"While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving.","['individuals with AUD', 'heavy-drinking alcohol-dependent individuals', 'healthy volunteers', 'non-treatment-seeking, heavy-drinking, alcohol-dependent individuals']","['placebo, 1 mcg/kg or 3 mcg/kg of intravenous ghrelin', 'cue-reactivity procedure in a bar-like setting, which included exposure to both neutral (juice) and alcohol cues', 'placebo', 'ghrelin']","['endogenous cortisol and aldosterone serum concentrations', 'alcohol craving', 'endogenous serum cortisol and aldosterone concentrations', 'serum cortisol and aldosterone concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}]",,0.0591482,"While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving.","[{'ForeName': 'Carolina L', 'Initials': 'CL', 'LastName': 'Haass-Koffler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA; Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA. Electronic address: carolina_haass-koffler@brown.edu.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Long', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA. Electronic address: mehdi.farokhnia@nih.gov.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kenna', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Swift', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA; Veterans Affairs Medical Center, Providence, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA; Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107711']
3402,30240342,Parents' attitudes toward consent and data sharing in biobanks: A multisite experimental survey.,"BACKGROUND


The factors influencing parents' willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents' willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness.
METHODS


This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of three consent and data-sharing scenarios.
RESULTS


In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one's child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity.
CONCLUSIONS


Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks.",2018,"Overall, 55% (95% confidence interval 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios.","[""Parents' attitudes toward consent and data sharing in biobanks"", '5737 respondents were parents of minor children', ""parents' willingness to enroll their children"", 'patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups', 'In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate']",[],"['Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C2713450', 'cui_str': 'Data Sharing'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205350', 'cui_str': 'Disproportionate (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0681189', 'cui_str': 'Religiosity (observable entity)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",90000.0,0.0329352,"Overall, 55% (95% confidence interval 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios.","[{'ForeName': 'Armand H Matheny', 'Initials': 'AHM', 'LastName': 'Antommaria', 'Affiliation': ""a Ethics Center , Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Brothers', 'Affiliation': 'c Department of Pediatrics , University of Louisville.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Myers', 'Affiliation': 'c Department of Pediatrics , University of Louisville.'}, {'ForeName': 'Yana B', 'Initials': 'YB', 'LastName': 'Feygin', 'Affiliation': 'c Department of Pediatrics , University of Louisville.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Aufox', 'Affiliation': 'd Center for Genetic Medicine , Northwestern University.'}, {'ForeName': 'Murray H', 'Initials': 'MH', 'LastName': 'Brilliant', 'Affiliation': 'e Center for Human Genetics , Marshfield Clinic Research Institute.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Conway', 'Affiliation': 'f Essentia Institute of Rural Health.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'g Department of Bioethics and Humanities , University of Washington.'}, {'ForeName': ""Nanibaa' A"", 'Initials': 'NA', 'LastName': 'Garrison', 'Affiliation': ""h Treuman Katz Center for Pediatric Bioethics , Seattle Children's Hospital and Research Institute.""}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'j Department of Population Health Science and Policy , Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'k Departments of Medicine (Medical Genetics) and Genome Sciences , University of Washington.'}, {'ForeName': 'Rongling', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'l Division of Genomic Medicine , National Human Genome Research Institute.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'm Kaiser Permanente Washington Health Research Institute.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': 'n University of Minnesota Medical School.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McCormick', 'Affiliation': 'o Biomedical Ethics Program, Mayo Clinic.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Mercaldo', 'Affiliation': 'p Department of Biostatistics , Vanderbilt University.'}, {'ForeName': 'Melanie F', 'Initials': 'MF', 'LastName': 'Myers', 'Affiliation': 'b Department of Pediatrics , University of Cincinnati College of Medicine.'}, {'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'Sanderson', 'Affiliation': 'r Department of Genetics and Genomic Sciences , Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 's Vanderbilt Epidemiology Center , Vanderbilt University Medical Center.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Schildcrout', 'Affiliation': 't Department of Biostatistics , Vanderbilt University.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Williams', 'Affiliation': 'u Genomic Medicine Institute, Geisinger.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Smith', 'Affiliation': 'v Center for Genetic Medicine , Northwestern University.'}, {'ForeName': 'Ellen Wright', 'Initials': 'EW', 'LastName': 'Clayton', 'Affiliation': 'w Center for Biomedical Ethics and Society, Vanderbilt University Medical Center.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""x Division of Genetics and Genomics and the Manton Center for Orphan Diseases Research , Boston Children's Hospital.""}]",AJOB empirical bioethics,['10.1080/23294515.2018.1505783']
3403,30762190,Acceptability and Preliminary Efficacy of an Online HIV Prevention Intervention for Single Young Men Who Have Sex with Men Seeking Partners Online: The myDEx Project.,"Prevention of new cases of HIV among young gay, bisexual and other men who have sex with men (YGBMSM; ages 18-24) remains a priority. We developed and pilot tested an online intervention (myDEx) using a pilot randomized trial design with 180 online-recruited single YGBMSM who reported recent unprotected anal intercourse, self-reporting as HIV negative or status-unaware, and who met sexual partners through online dating applications. myDEx participants reported higher overall satisfaction (d = 0.46) and willingness to recommend the intervention to friends (d = 0.48) than controls. myDEx participants were less likely to report foregoing condoms to achieve an emotional connection with a partner (d =0 .43), and more likely to report greater emotional regulation during their partner-seeking behaviors (d = 0.44). myDEx participants reported fewer partners with whom they had condomless receptive anal sex (d = 0.48). Our pilot results demonstrate the potential of the myDEx intervention, suggesting that a larger efficacy trial may be warranted in the future.",2019,myDEx participants reported higher overall satisfaction (d = 0.46) and willingness to recommend the intervention to friends (d = 0.48) than controls.,"['180 online-recruited single YGBMSM who reported recent unprotected anal intercourse, self-reporting as HIV negative or status-unaware, and who met sexual partners through online dating applications', 'Who Have Sex with Men Seeking Partners Online', 'Single Young Men', 'new cases of HIV among young gay, bisexual and other men who have sex with men (YGBMSM; ages 18-24']","['myDEx', 'online intervention (myDEx', 'Online HIV Prevention Intervention']","['condomless receptive anal sex', 'emotional regulation', 'overall satisfaction']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0875538,myDEx participants reported higher overall satisfaction (d = 0.46) and willingness to recommend the intervention to friends (d = 0.48) than controls.,"[{'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. bjose@upenn.edu.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Tingler', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Demers', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Connochie', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gage', 'Initials': 'G', 'LastName': 'Gillard', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shaver', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tanaka', 'Initials': 'T', 'LastName': 'Chavanduka', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Harper', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02426-7']
3404,30246923,Feasibility and acceptability of a motivational interviewing breastfeeding peer support intervention.,"An uncontrolled study with process evaluation was conducted in three U.K. community maternity sites to establish the feasibility and acceptability of delivering a novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind). Peer-supporters were trained to deliver the Mam-Kind intervention that provided intensive one-to-one peer-support, including (a) antenatal contact, (b) face-to-face contact within 48 hr of birth, (c) proactive (peer-supporter led) alternate day contact for 2 weeks after birth, and (d) mother-led contact for a further 6 weeks. Peer-supporters completed structured diaries and audio-recorded face-to-face sessions with mothers. Semistructured interviews were conducted with a purposive sample of mothers, health professionals, and all peer-supporters. Interview data were analysed thematically to assess intervention acceptability. Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool. Eight peer-supporters delivered the Mam-Kind intervention to 70 mothers in three National Health Service maternity services. Qualitative interviews with mothers (n = 28), peer-supporters (n = 8), and health professionals (n = 12) indicated that the intervention was acceptable, and health professionals felt it could be integrated with existing services. There was high fidelity to intervention content; 93% of intervention objectives were met during sessions. However, peer-supporters reported difficulties in adapting from an expert-by-experience role to a collaborative role. We have established the feasibility and acceptability of providing breastfeeding peer-support using a MI-informed approach. Refinement of the intervention is needed to further develop peer-supporters' skills in providing mother-centred support. The refined intervention should be tested for effectiveness in a randomised controlled trial.",2019,"Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool.","['70 mothers in three National Health Service maternity services', 'Qualitative interviews with mothers (n\xa0=\xa028), peer-supporters (n\xa0=\xa08), and health professionals (n\xa0=\xa012']","['Eight peer-supporters delivered the Mam-Kind intervention', 'Peer-supporters completed structured diaries and audio-recorded face-to-face sessions with mothers', 'novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind', 'Mam-Kind intervention that provided intensive one-to-one peer-support, including (a) antenatal contact, (b) face-to-face contact within 48\xa0hr of birth, (c) proactive (peer-supporter led) alternate day contact', 'motivational interviewing breastfeeding peer support intervention']",['Feasibility and acceptability'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0335016,"Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Merrett', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McQuire', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Grant', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Tedstone', 'Affiliation': 'Royal United Hospitals Bath, NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Hunter', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Public Health, Policy and Social Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Department of Public Health, Policy and Social Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Shantini', 'Initials': 'S', 'LastName': 'Paranjothy', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12703']
3405,31840273,Autistic traits in mentalization-based treatment for concurrent borderline personality disorder and substance use disorder: Secondary analyses of a randomized controlled feasibility study.,"Autism is suggested to be a dimensional construct and often represents a comorbid state. However, research on the clinical implications of the presence of autistic traits is scarce. This study aimed to investigate the impact of subclinical autistic traits in mentalization-based treatment (MBT) for concurrent borderline personality disorder (BPD) and substance use disorder (SUD). Based on the data of a randomized controlled feasibility study by Philips, Wennberg, Konradsson, and Franck (2018), secondary analyses were conducted. It was tested, if patients' (N = 46) levels of autistic traits were associated with treatment outcome measured in the course of and after treatment using interviews and self-report measures. Participants' autistic traits were not associated with the change in the severity of BPD throughout and at the end of the treatment. However, results showed associations between autistic traits and the change in patients' consumption of alcohol in the course of MBT. Furthermore, there was an association between autistic traits and the change in mentalizing capacity at the end of MBT, indicating that elevated autistic traits were associated with an improvement in mentalizing capacity. Autistic traits on a subclinical level do not appear to be a complicating factor in MBT for concurrent BPD and SUD. On the contrary, in terms of mentalizing capacity autistic traits might be associated with a larger potential for improvement or facilitate treatment outcome. Further research is needed to explore the role of higher autistic traits in treatment of this special patient group.",2020,"Furthermore, there was an association between autistic traits and the change in mentalizing capacity at the end of MBT, indicating that elevated autistic traits were associated with an improvement in mentalizing capacity.","['concurrent borderline personality disorder and substance use disorder', 'concurrent borderline personality disorder (BPD) and substance use disorder (SUD']","['mentalization-based treatment (MBT', 'mentalization-based treatment']","['severity of BPD', 'mentalizing capacity', 'autistic traits', 'subclinical autistic traits', 'Autistic traits']","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}]",,0.0360599,"Furthermore, there was an association between autistic traits and the change in mentalizing capacity at the end of MBT, indicating that elevated autistic traits were associated with an improvement in mentalizing capacity.","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kaltenegger', 'Affiliation': 'Department of Public Health Sciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Philips', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wennberg', 'Affiliation': 'Department of Public Health Sciences, Stockholm University, Stockholm, Sweden.'}]",Scandinavian journal of psychology,['10.1111/sjop.12595']
3406,30614013,Comparison between topical recombinant human epidermal growth factor and Aloe vera gel in combination with ablative fractional carbon dioxide laser as treatment for striae alba: A randomized double-blind trial.,"OBJECTIVES


Striae distensae are linear atrophic dermal scars. Despite several currently available therapeutic modalities, no consistently effective therapies have been established. This study aimed to evaluate and compare the efficacy of topical recombinant human epidermal growth factor (rhEGF) and ablative fractional carbon dioxide (CO 2  ) laser (AFXL) versus ablative fractional CO 2  laser and topical Aloe vera gel in treating striae alba.
METHODS


A total of 24 participants with striae alba were enrolled. Patients' striae were divided into the left and right sides. Participants were treated with fractional CO 2  laser on both sides for three sessions at 4-week intervals. Immediately after the laser treatment, each side of the striae was randomly assigned to either rhEGF or Aloe vera gel treatment. Patients were required to apply the medication twice daily up to 1 month after the last laser treatment session. Texture, average melanin, and melanin variation were assessed at pretreatment, 1 month after the first, second, and third treatments, and 6 months after the last treatment. Participants were asked to complete a self-administered questionnaire. Nine participants underwent skin biopsies of the nontreated and treated striae, which were obtained from each treated side.
RESULTS


Both sides of the treatment area showed significant improvement in texture starting from 1-month follow-up, which sustained up to 6 months after the final treatment, albeit without statistically significant difference between the rhEGF- and Aloe vera-treated sides (P < 0.001, 0.003, and 0.002 for the AFXL-rhEGF-treated side and P = 0.024, 0.001, and 0.001 for the AFXL-Aloe-treated side at 1 month after the first treatment, 1 month after the last treatment, and 6 months after the last treatment, respectively). Participants expressed satisfaction with the AFXL-rhEGF-treated side, which showed significantly greater marked improvement (at 50%) than the AFXL-Aloe-treated side at 6 months after the final treatment (P = 0.034). Post-inflammatory hyperpigmentation (PIH) occurred in 95.8% of participants, which decreased after 6 months compared with baseline. Both treatments improved melanin variation at 6 months after the final treatment, although without significant difference from pretreatment between both groups. Skin biopsy revealed a statistically significant increase in epidermal thickness and decrease in elastic fragmentation in both groups.
CONCLUSION


AFXL-rhEGF and AFXL-Aloe significantly improved the striae surface texture. PIH was the most common side effect, which improved at 6 months. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"Both treatments improved melanin variation at 6 months after the final treatment, although without significant difference from pretreatment between both groups.","[""Patients' striae"", '24 participants with striae alba were enrolled', '2019', 'striae alba']","['topical recombinant human epidermal growth factor (rhEGF) and ablative fractional carbon dioxide (CO 2  ) laser (AFXL', 'rhEGF or Aloe vera gel treatment', 'ablative fractional carbon dioxide laser', 'AFXL-rhEGF and AFXL-Aloe', 'fractional CO 2  laser', 'topical recombinant human epidermal growth factor and Aloe vera gel']","['striae surface texture', 'Texture, average melanin, and melanin variation', 'texture starting', 'elastic fragmentation', 'Post-inflammatory hyperpigmentation (PIH', 'epidermal thickness', 'melanin variation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152459', 'cui_str': 'Stretch Marks'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0974143', 'cui_str': 'Aloe vera gel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}]","[{'cui': 'C0152459', 'cui_str': 'Stretch Marks'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}]",24.0,0.0392066,"Both treatments improved melanin variation at 6 months after the final treatment, although without significant difference from pretreatment between both groups.","[{'ForeName': 'Wareeporn', 'Initials': 'W', 'LastName': 'Disphanurat', 'Affiliation': 'Division of Dermatology, Department of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Arisa', 'Initials': 'A', 'LastName': 'Kaewkes', 'Affiliation': 'Division of Dermatology, Department of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Worapop', 'Initials': 'W', 'LastName': 'Suthiwartnarueput', 'Affiliation': 'Department of Pathology and Forensic Medicine, Thammasat University, Pathumthani, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23052']
3407,30741047,Impact of causal explanations for social anxiety disorder on stigma and treatment perceptions.,"Background and aims : There is evidence to suggest that biogenetic explanations for symptoms of mental disorders have become increasingly popular. Research suggests that such explanations provokes mixed blessings: biological explanations may reduce blame but also encourage prognostic pessimism and promote perceptions of pharmacological treatment over psychotherapy. The goal of this study was to evaluate the impact of different causal explanations on social anxiety disorder. Method : About 205 adults completed an experiment where they read a vignette describing an individual with social anxiety disorder and were randomly assigned to a symptom explanation that was: (1) biological, (2) biopsychosocial, (3) psychosocial, or (4) no explanation. Results : The psychosocial condition yielded the highest perceived credibility and lowest attributions of blame. The biological condition promoted positive expectations for medication effectiveness compared to other conditions. Conditions did not differ on prognostic expectations. Conclusions : Calls attention to the risk of generalizing from previous research to mental disorders as a whole.",2020,The psychosocial condition yielded the highest perceived credibility and lowest attributions of blame.,['205 adults completed an experiment where they read a vignette describing an individual with social anxiety disorder'],"['symptom explanation that was: (1) biological, (2) biopsychosocial, (3) psychosocial, or (4) no explanation']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]",[],205.0,0.0268437,The psychosocial condition yielded the highest perceived credibility and lowest attributions of blame.,"[{'ForeName': 'Casey A', 'Initials': 'CA', 'LastName': 'Schofield', 'Affiliation': 'Psychology Department, Skidmore College, Saratoga Springs, NY, USA and.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Abdul-Chani', 'Affiliation': 'Psychology Department, Skidmore College, Saratoga Springs, NY, USA and.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Butler Hospital/Brown University Warren Alpert School of Medicine, Providence, RI, USA.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2018.1487543']
3408,31884935,Formulation and in vitro Evaluation of Fast Dissolving Tablets of Febuxostat Using Co-Processed Excipients.,"BACKGROUND


Febuxostat is a novel, orally-administered, powerful, non-purine, xanthine oxidase inhibitor used for treating gout and ceaseless tophaceous gout. The drug exhibits low bioavailability (about 49%) which is ascribed to its dissolution rate-limited absorption.
OBJECTIVE


The current work is aimed to provide a novel strategy to improve the dissolution profile and thus, the bioavailability of Febuxostat.
METHODS


Formulation of Fast Dissolving Tablets (FDT) is anticipated to provide immediate release of the drug, which in turn, will improve its dissolution profile to provide the initial surge in plasma concentration required in an acute gout attack. Incorporation of co-processed excipients in a tablet is known to improve the compressibility and disintegration characteristics of the tablets, which, in turn, result in enhanced in vitro drug release and improved bioavailability. A combination of crospovidone (it rapidly wicks saliva into the tablet to create the volume development and hydrostatic weight important to give quick disintegration) and microcrystalline cellulose (a highly compressible ingredient with good wicking and absorbing capacity) was, therefore, used as co-processed excipients.
RESULTS


The tablets were prepared by direct compression technique with the application of a 32 randomized full factorial design. The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show a better drug release profile in comparison to available marketed formulation.
CONCLUSION


So, it can be concluded that the developed fast release formulation was found to exhibit convincing in vitro results and may prove a boon in the treatment of acute gout attack after establishing in vivo potential.",2020,The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show better drug release profile in comparison to available marketed formulation.,[],"['Febuxostat', 'fast dissolving tablets (FDT', 'crospovidone']",['bioavailability'],[],"[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0728803', 'cui_str': 'Crospovidone'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0230538,The prepared tablets were able to release more than 80% of the drug within 10 minutes of the start of dissolution testing and were able to show better drug release profile in comparison to available marketed formulation.,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Pharmacy, Rayat Bahra Institute of Pharmacy, V. Bohan, Hoshiarpur, Punjab 146004, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mittal', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gulati', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India.'}]",Recent patents on drug delivery & formulation,['10.2174/1872211314666191224121044']
3409,31748296,Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).,"INTRODUCTION


Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.
METHODS AND ANALYSIS


We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.
ETHICS AND DISSEMINATION


This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN10386621.",2019,"Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures.","['adult patients with oesophageal cancer', 'patients with oesophageal cancer-the Randomised', 'patients with oesophageal cancer']","['laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO', 'Laparoscopically assisted versus open oesophagectomy', 'Oesophagectomy: Minimally Invasive or Open (ROMIO', 'Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy', 'LAO with OO']","['patient-reported physical function', 'postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0534702', 'cui_str': 'lanthanum oxide'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.281004,"Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures.","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Brierley', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK r.brierley@bristol.ac.uk.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Berrisford', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Kerry N L', 'Initials': 'KNL', 'LastName': 'Avery', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Caoimhe T', 'Initials': 'CT', 'LastName': 'Rice', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Moure-Fernandez', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Skilton', 'Affiliation': 'Medical Illustration, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Boddy', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Underwood', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vohra', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Catton', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Kish', 'Initials': 'K', 'LastName': 'Pursnani', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Melhado', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Alkhaffaf', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Krysztopik', 'Affiliation': 'Gastroenterology Department, Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lamb', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Howes', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Chalmers', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Cousins', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Gastro-Oesophageal Support and Help Group, Bristol, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Wickens', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wilkerson', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hollowood', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Streets', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Titcomb', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Martyn Lee', 'Initials': 'ML', 'LastName': 'Humphreys', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wheatley', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Sanders', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Ariyarathenam', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Noble', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Couper', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard J E', 'Initials': 'RJE', 'LastName': 'Skipworth', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Deans', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sukhbir', 'Initials': 'S', 'LastName': 'Ubhi', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bowrey', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Exon', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Daya Shetty', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Chaparala', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Akhtar', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Farooq', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Parsons', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Neil T', 'Initials': 'NT', 'LastName': 'Welch', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Houlihan', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schranz', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rea', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hindmarsh', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Maitland', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Howie', 'Affiliation': 'Gastroenterology Department, Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Christopher Paul', 'Initials': 'CP', 'LastName': 'Barham', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030907']
3410,31174846,Cholinergic Modulation of Exposure Disrupts Hippocampal Processes and Augments Extinction: Proof-of-Concept Study With Social Anxiety Disorder.,"BACKGROUND


In rodents, context specificity of Pavlovian extinction is attenuated by manipulations that impair hippocampal function, including systemic administration of scopolamine, a muscarinic-cholinergic receptor antagonist. Context renewal translates into return of fear following exposure therapy to feared situations. We evaluated the effectiveness of scopolamine for attenuating context renewal of phobic fear in humans.
METHODS


A total of 60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking were randomized to placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine. They completed seven exposure sessions in an exposure context and subsequently tested in the exposure context (extinction retest) versus a different context (context renewal test), which were counterbalanced. Testing 1 month later occurred in the exposure context (long-term extinction retest). Fear measures included skin conductance and self-reported distress during speeches. Hippocampus-dependent cognitive tasks were completed as well.
RESULTS


Scopolamine augmented extinction across exposure sessions on skin conductance response and skin conductance level. Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear. Scopolamine led to lower skin conductance response at long-term extinction retest. Scopolamine impaired performance on a cognitive task of hippocampal function.
CONCLUSIONS


Noninvasive and well-tolerated scopolamine impaired hippocampal processes and augmented extinction during exposure. Drug-free effects persisted 1 month later. Findings at context renewal were limited and suggestive only. Further investigation is warranted with varying scopolamine dosages.",2019,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"['phobic fear in humans', '60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking']","['placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine', 'placebo', 'Scopolamine', 'scopolamine']","['Lower skin conductance response', 'skin conductance and self-reported distress', 'lower skin conductance response', 'skin conductance response and skin conductance level']","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0385867,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California. Electronic address: mcraske@mednet.ucla.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fanselow', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bystritksy', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.04.012']
3411,31684696,Interventions for pityriasis rosea.,"BACKGROUND


Pityriasis rosea is a scaly, itchy rash that mainly affects young adults and lasts for 2 to 12 weeks. The effects of many available treatments are uncertain. This is an update of a Cochrane Review first published in 2007.
OBJECTIVES


To assess the effects of interventions for the management of pityriasis rosea in any individual diagnosed by a medical practitioner.
SEARCH METHODS


We updated our searches of the following databases to October 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched five trials registers. We also checked the reference lists of included and excluded studies, contacted trial authors, scanned the abstracts from major dermatology conference proceedings, and searched the CAB Abstracts database. We searched PubMed for adverse effects to November 2018.
SELECTION CRITERIA


Randomised controlled trials of interventions in pityriasis rosea. Treatment could be given in a single therapy or in combination. Eligible comparators were no treatment, placebo, vehicle only, another active compound, or placebo radiation treatment.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by the Cochrane. Our key outcomes were good or excellent rash improvement within two weeks, rated separately by the participant and medical practitioner; serious adverse events; resolution of itch within two weeks (participant-rated); reduction in itch score within two weeks (participant-rated); and minor participant-reported adverse events not requiring withdrawal of the treatment.
MAIN RESULTS


We included 14 trials (761 participants). In general, risk of selection bias was unclear or low, but risk of performance bias and reporting bias was high for 21% of the studies. Participant age ranged from 2 to 60 years, and sex ratio was similar. Disease severity was measured by various severity indices, which the included studies did not categorise. Six studies were conducted in India, three in Iran, two in the Philippines, and one each in Pakistan, the USA, and China. The included studies were conducted in dermatology departments and a paediatric clinic. Study duration ranged from 5 to 26 months. Three studies were funded by drug manufacturers; most studies did not report their funding source. The included studies assessed macrolide antibiotics, an antiviral agent, phototherapy, steroids and antihistamine, and Chinese medicine. None of the studies measured participant-rated good or excellent rash improvement. All reported outcomes were assessed within two weeks of treatment, except for adverse effects, which were measured throughout treatment. There is probably no difference between oral clarithromycin and placebo in itch resolution (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.47 to 1.52; 1 study, 28 participants) or rash improvement (medical practitioner-rated) (RR 1.13, 95% CI 0.89 to 1.44; 1 study, 60 participants). For this comparison, there were no serious adverse events (1 study, 60 participants); minor adverse events and reduction in itch score were not measured; and all evidence was of moderate quality. When compared with placebo, erythromycin may lead to increased rash improvement (medical practitioner-rated) (RR 4.02, 95% CI 0.28 to 56.61; 2 studies, 86 participants, low-quality evidence); however, the 95% CI indicates that the result may also be compatible with a benefit of placebo, and there may be little or no difference between treatments. Itch resolution was not measured, but one study measured reduction in itch score, which is probably larger with erythromycin (MD 3.95, 95% CI 3.37 to 4.53; 34 participants, moderate-quality evidence). In the same single, small trial, none of the participants had a serious adverse event, and there was no clear difference between groups in minor adverse events, which included gastrointestinal upset (RR 2.00, CI 0.20 to 20.04; moderate-quality evidence). Two trials compared oral azithromycin to placebo or vitamins. There is probably no difference between groups in itch resolution (RR 0.83, 95% CI 0.28 to 2.48) or reduction in itch score (MD 0.04, 95% CI -0.35 to 0.43) (both outcomes based on one study; 70 participants, moderate-quality evidence). Low-quality evidence from two studies indicates there may be no difference between groups in rash improvement (medical practitioner-rated) (RR 1.02, 95% CI 0.52 to 2.00; 119 participants). In these same two studies, no serious adverse events were reported, and there was no clear difference between groups in minor adverse events, specifically mild abdominal pain (RR 5.82, 95% CI 0.72 to 47.10; moderate-quality evidence). Acyclovir was compared to placebo, vitamins, or no treatment in three trials (all moderate-quality evidence). Based on one trial (21 participants), itch resolution is probably higher with placebo than with acyclovir (RR 0.34, 95% CI 0.12 to 0.94); reduction in itch score was not measured. However, there is probably a significant difference between groups in rash improvement (medical practitioner-rated) in favour of acyclovir versus all comparators (RR 2.45, 95% CI 1.33 to 4.53; 3 studies, 141 participants). Based on the same three studies, there were no serious adverse events in either group, and there was probably no difference between groups in minor adverse events (only one participant in the placebo group experienced abdominal pain and diarrhoea). One trial compared acyclovir added to standard care (calamine lotion and oral cetirizine) versus standard care alone (24 participants). The addition of acyclovir may lead to increased itch resolution (RR 4.50, 95% CI 1.22 to 16.62) and reduction in itch score (MD 1.26, 95% CI 0.74 to 1.78) compared to standard care alone. Rash improvement (medical practitioner-rated) was not measured. The trial reported no serious adverse events in either group, and there may be no difference between groups in minor adverse events, such as headache (RR 7.00, 95% CI 0.40 to 122.44) (all results based on low-quality evidence).
AUTHORS' CONCLUSIONS


When compared with placebo or no treatment, oral acyclovir probably leads to increased good or excellent, medical practitioner-rated rash improvement. However, evidence for the effect of acyclovir on itch was inconclusive. We found low- to moderate-quality evidence that erythromycin probably reduces itch more than placebo. Small study sizes, heterogeneity, and bias in blinding and selective reporting limited our conclusions. Further research is needed to investigate different dose regimens of acyclovir and the effect of antivirals on pityriasis rosea.",2019,"There is probably no difference between groups in itch resolution (RR 0.83, 95% CI 0.28 to 2.48) or reduction in itch score (MD 0.04, 95% CI -0.35 to 0.43) (both outcomes based on one study; 70 participants, moderate-quality evidence).","['pityriasis rosea', '24 participants', 'Six studies were conducted in India, three in Iran, two in the Philippines, and one each in Pakistan, the USA, and China', '14 trials (761 participants']","['acyclovir', 'placebo or vitamins', 'macrolide antibiotics, an antiviral agent, phototherapy, steroids and antihistamine, and Chinese medicine', 'placebo', 'placebo, erythromycin', 'azithromycin', 'erythromycin', 'placebo, vehicle only, another active compound, or placebo radiation treatment', 'placebo, vitamins', 'standard care (calamine lotion and oral cetirizine', 'Acyclovir', 'clarithromycin', 'standard care alone']","['serious adverse event', 'good or excellent, medical practitioner-rated rash improvement', 'itch score', 'serious adverse events', 'reduction in itch score', 'rash improvement', 'gastrointestinal upset', 'itch resolution', 'adverse events', 'Rash improvement (medical practitioner-rated', 'mild abdominal pain', 'headache', 'adverse events and reduction in itch score', 'Disease severity', 'excellent rash improvement', 'adverse effects', 'abdominal pain and diarrhoea', 'Itch resolution']","[{'cui': 'C0032026', 'cui_str': 'Pityriasis Rosea'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C1522449', 'cui_str': 'Radiation Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0357929', 'cui_str': 'Calamine'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",761.0,0.537574,"There is probably no difference between groups in itch resolution (RR 0.83, 95% CI 0.28 to 2.48) or reduction in itch score (MD 0.04, 95% CI -0.35 to 0.43) (both outcomes based on one study; 70 participants, moderate-quality evidence).","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Contreras-Ruiz', 'Affiliation': 'Hospital General Dr. Manuel Gea González, Department of Dermatology, Puente de Piedra 150-T1-C111. Col. Toriello Guerra, Mexico City, Mexico, 14050.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peternel', 'Affiliation': 'Clinical Hospital Center Rijeka, Department of Dermatovenereology, Kresimirova 42, Rijeka, Croatia, 51000.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jiménez Gutiérrez', 'Affiliation': 'Universidad Tecnologica de México-Laureate International Universities, Adscrito Unidad de Investigación Traslacional, Kinchil 234-3, Col. Heroes de Padierna. Delegación Tlalpan, México.DF, DF, Mexico, 14200.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Culav-Koscak', 'Affiliation': 'General hospital ""Dr. Ivo Pedisic"", Department of Dermatology and Venereology, J.J. Strossmayera 59, Sisak, Croatia, 44000.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Reveiz', 'Affiliation': 'Free time independent Cochrane reviewer, Potomac, MD, USA.'}, {'ForeName': 'Maria de Lourdes', 'Initials': 'ML', 'LastName': 'Silbermann-Reynoso', 'Affiliation': ""The University of Nottingham, c/o Cochrane Skin Group, A103, King's Meadow Campus, Lenton Lane, Nottingham, UK, NG7 2NR.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005068.pub3']
3412,31759286,Effectiveness of a group intervention led by lay health workers in reducing the incidence of postpartum depression in South India.,"BACKGROUND


Postnatal depression is a highly prevalent disorder with serious implications on maternal and child outcomes. There are few studies examining feasible interventions in low-middle-income community settings.
AIMS


To assess the effectiveness of a low intensity group intervention led by lay workers during the antenatal period in reducing postnatal depression at 6-2 weeks postpartum.
METHODS


A parallel group design with both positive and negative controls was employed. 1 community site was allocated to each of the 3 arms. The active intervention consisted of problem based sessions with cognitive behavioural components. The primary outcome was the presence of depression on CIS-R and secondary outcome measures where Global Assessment of Functioning (GAF) scores, EPNDS scores and participant perceptions.
RESULTS


69, 75 and 70 women received active, positive control and negative control interventions respectively. Post partum depression diagnosed with the CIS-R was present in 14.06% (C.I.- 5.55%-22.57%) and 22.62% (C.I.15.62%-29.63%) in the active arm and two control (combined) arms respectively. There was a 1/3 lower proportion of postpartum depression and impaired functioning in the intervention group, though statistical significance was not reached (p = 0.30). There were high levels of satisfaction reported for the active intervention.
CONCLUSION


There were trends for the possible effectiveness for this low intensity intervention and conclusions regarding its effectiveness can't be made as the sample size was small. There is a need to explore and develop locally relevant, innovative and feasible strategies for prevention of postnatal depression in resource constrained enviroments.",2020,"There was a 1/3 lower proportion of postpartum depression and impaired functioning in the intervention group, though statistical significance was not reached (p = 0.30).",['postpartum depression in South India'],['problem based sessions with cognitive behavioural components'],"['postnatal depression', 'Global Assessment of Functioning (GAF) scores, EPNDS scores and participant perceptions', 'postpartum depression and impaired functioning', 'presence of depression on CIS-R']","[{'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.234391,"There was a 1/3 lower proportion of postpartum depression and impaired functioning in the intervention group, though statistical significance was not reached (p = 0.30).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'George', 'Affiliation': 'DR. SMCSI Medical College, Karakonam, Trivandrum, 695004, Kerala, India. Electronic address: mukkath@yahoo.com.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Kumar V', 'Affiliation': 'Department of Psychiatry, Dr. Somervell Memorial CSI Medical College, Karakonam, Kerala, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Girish', 'Affiliation': 'Department of Epidemiology, National Institute of Mental health and Neurosciences, Bangalore, India.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2019.101864']
3413,31563804,Positive urgency worsens the impact of normative feedback on 21st birthday drinking.,"BACKGROUND


The 21st birthday is associated with more alcohol consumption and negative consequences than any other occasion. The current study investigated how positive urgency, the tendency to act rashly in response to positive emotions, influences 21st birthday drinking and the effectiveness of a single event text message intervention designed to reduce 21st birthday drinking and related negative consequences.
METHODS


Participants were 183 undergraduate students (69% female, 86% white) about to turn 21. Participants were randomly assigned to either a text message intervention or control condition. Those in the intervention condition received one text message the day before their 21st birthday that provided personalized normative feedback and one text message on the day of their 21st birthday. Participants reported actual alcohol consumption the day after their 21st birthday celebration.
RESULTS


Hierarchical linear regression found that, after controlling for sex, intervention condition, and planned drinking, positive urgency was associated with greater number of drinks (β = .15, p = .031) and drinking problems (β = .25, p = .001). A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]): At high levels of positive urgency, the intervention condition was associated with drinking more than planned, which significantly mediated the relationship between intervention and alcohol-related consequences; the mediation was not significant at mean or low levels of positive urgency.
CONCLUSIONS


These findings are the first to link positive urgency with 21st birthday drinking and to empirically demonstrate that positive urgency negatively impacts the effectiveness of an intervention aimed at reducing alcohol consumption.",2019,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","['Participants were 183 undergraduate students (69% female, 86% white) about to turn 21']",['text message intervention or control condition'],"['actual alcohol consumption', 'drinking problems']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0198354,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","[{'ForeName': 'Zachary T', 'Initials': 'ZT', 'LastName': 'Whitt', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States. Electronic address: zacwhitt@iu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States.'}, {'ForeName': 'Nichea', 'Initials': 'N', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States; Department of Psychology, University of Rhode Island, Kingston, RI, United States; Rhode Island Training School, Department of Children, Youth and Families, Cranston, RI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Schick', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Cyders', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107559']
3414,15029102,Repaglinide is more efficient than glimepiride on insulin secretion and post-prandial glucose excursions in patients with type 2 diabetes. A short term study.,"OBJECTIVES


To compare the effect of Repaglinide vs Glimepiride on glucose- and meal-induced insulin secretion and on meal-test induced postprandial glucose excursions.
METHODS


After 2 weeks washout period, a 3-Month randomised, cross-over parallel group trial of R (1 mg x 2/die) vs G (2 mg/die) in 14 patients with type 2 diabetes ""naive"" in diet treatment was made.
RESULTS


Both R and G significantly but similarly lowered fasting glucose levels and improved fasting plasma insulin levels vs baseline. Hyperglycemic clamp showed that both 1st (129.15 +/- 23.6 vs 106.90 +/- 18.6 pmol/L; p=0.01) and 2nd phase (189.42 +/- 34.4 vs 144.21 +/- 37.3 pmol/L; p=0.003) B-cell response to glucose as well as area under the curve (52.07 +/- 10.86 vs 39.54 +/- 10.27 micromol/L x 120'; p=0.005) were greater in R than G groups. Insulin action (4.0 +/- 1.1 vs 3.2 +/- 0.9 mg x Kg x 60'/microU/mL; p=0.046) was also improved by R than G administration. In the meal test, R therapy produced a more rapId induction of insulin secretion during the first part. In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R). Consequently, glucose spike at 60 min was higher in G group compared to glucose spike at 45 min in R group (p=0.002).
CONCLUSIONS


Our study demonstrates that R is more efficient that G on improving glucose- and meal- induced insulin secretion as well as on controlling for postprandial glucose excursion.",2004,"In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R).","['14 patients with type 2 diabetes', 'patients with type 2 diabetes']","['naive"" in diet treatment was made', 'Repaglinide', 'Repaglinide vs Glimepiride', 'glimepiride']","['mean rise in insulin secretion', 'Hyperglycemic clamp', 'glucose spike', 'insulin secretion and post-prandial glucose excursions', 'fasting plasma insulin levels', 'Insulin action', 'fasting glucose levels', 'rapId induction of insulin secretion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",14.0,0.0174799,"In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R).","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rizzo', 'Affiliation': 'Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grella', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Passariello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70093-9']
3415,30918967,"Dolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Trial.","BACKGROUND


The concurrent treatment of tuberculosis and human immunodeficiency virus (HIV) is challenging, owing to drug interactions, overlapping toxicities, and immune reconstitution inflammatory syndrome (IRIS). The efficacy and safety of dolutegravir (DTG) were assessed in adults with HIV and drug-susceptible tuberculosis.
METHODS


International Study of Patients with HIV on Rifampicin ING is a noncomparative, active-control, randomized, open-label study in HIV-1-infected antiretroviral therapy-naive adults (CD4+ ≥50 cells/mm3). Participants on rifampicin-based tuberculosis treatment ≤8 weeks were randomized (3:2) to receive DTG (50 mg twice daily both during and 2 weeks after tuberculosis therapy, then 50 mg once daily) or efavirenz (EFV; 600 mg daily) with 2 nucleoside reverse transcriptase inhibitors for 52 weeks. The primary endpoint was the proportion of DTG-arm participants with plasma HIV-1-RNA <50 copies/mL (responders) by the Food and Drug Administration Snapshot algorithm (intent-to-treat exposed population) at Week 48. The study was not powered to compare arms.
RESULTS


For DTG (n = 69), the baseline HIV-1 RNA was >100 000 copies/mL in 64% of participants, with a median CD4+ count of 208 cells/mm3; for EFV (n = 44), 55% of participants had HIV-1 RNA >100 000 copies/mL, with a median CD4+ count of 202 cells/mm3. The Week 48 response rates were 75% (52/69, 95% confidence interval [CI] 65-86%) for DTG and 82% (36/44, 95% CI 70-93%) for EFV. The DTG nonresponses were driven by non-treatment related discontinuations (n = 10 lost to follow-up). There were no deaths or study drug switches. There were 2 discontinuations for toxicity (EFV). There were 3 protocol-defined virological failures (2 DTG, no acquired resistance; 1 EFV, emergent resistance to nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors). The tuberculosis treatment success rate was high. Tuberculosis-associated IRIS was uncommon (4/arm), with no discontinuations for IRIS.
CONCLUSIONS


Among adults with HIV receiving rifampicin-based tuberculosis treatment, twice-daily DTG was effective and well tolerated.
CLINICAL TRIALS REGISTRATION


NCT02178592.",2020,"Week 48 response rate was 75% (52/69) (95% CI: 65%, 86%) for dolutegravir and 82% (36/44) (95% CI: 70%, 93%) for efavirenz.","['adults with HIV receiving', 'Participants on rifampicin-based tuberculosis treatment ≤8 weeks', 'adults with HIV and drug-susceptible tuberculosis', 'Patients Co-Infected with Tuberculosis and Hiv', 'HIV-1-infected ART-naïve adults (CD4+ 50 cells/mm3']","['Dolutegravir-Based Antiretroviral Therapy', 'efavirenz', 'rifampicin', 'dolutegravir']","['proportion of dolutegravir', 'toxicity (efavirenz', 'efficacy and safety of dolutegravir', 'response rate', 'virological failures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439243', 'cui_str': 'mm3'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.401008,"Week 48 response rate was 75% (52/69) (95% CI: 65%, 86%) for dolutegravir and 82% (36/44) (95% CI: 70%, 93%) for efavirenz.","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Desmond Tutu Human Immunodeficiency Virus (HIV) Foundation, Cape Town.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'Clinical HIV Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Instituto de Pesquisa Clínica Evandro Chagas Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ticona', 'Affiliation': 'Hospital Nacional Dos de Mayo, Universidad Nacional Mayor de San Marcos, Lima, Peru.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lacerda', 'Affiliation': 'Instituto Leônidas & Maria Deane (Fiocruz)/Tropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sued', 'Affiliation': 'Fundación Huésped, Buenos Aires, Argentina.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Belonosova', 'Affiliation': 'Regional Center For Prevention and Treatment of Acquired Immunodeficiency Syndrome and Infectious Diseases, Orel, Russia.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Ait-Khaled', 'Affiliation': 'ViiV Healthcare Ltd., Brentford.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, United Kingdom.'}, {'ForeName': 'Dannae', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'ViiV Healthcare Ltd., Melbourne, Victoria, Australia.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Talarico', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Keegan', 'Affiliation': 'ViiV Healthcare Ltd., Brentford.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare Ltd., Brentford.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz256']
3416,31763228,Treatment of Allergic Rhinitis: A Comparative Study of Traditional Antihistamine oral Rupatidine Versus Oral Rupatidine with a Lipid Based Nasal Ointment.,"Allergic rhinitis is a common and debilitating disease that has a major effect on the health related quality of life. The usage of corticosteroids topically and newer generation antihistamines have been the hallmark of recent advances in treatment of allergic rhinitis. Hence this study was taken to clinically evaluate the efficacy of lipid-based ointment and traditional antihistamine Rupatidine in treatment of moderate persistent allergic rhinitis. This study was designed to compare the efficacy of lipid-based ointment and traditional antihistamine in the treatment of moderate persistent allergic rhinitis. 60 Patients aged between 15 and 70 years with moderate to severe symptoms of allergic rhinitis were chosen after history taking, clinical examination and relevant lab investigations-nasal smear examination and serum IgE levels in specific. They were randomized into two groups and started on either lipid based ointment (to apply ointment to nasal vestibule twice daily) with tablet Rupaditine 10 mg OD and only tablet Rupatidine 10 mg OD alone. Patients were asked to observe the efficacy of their treatment on daily basis. Mean age of patients in lipid based ointment group with tablet Rupatidine was 33.53 years and only tablet Rupatidine group was 28.9 years. Positive family history was present in 13.3 % patients in group I with 26.6 % patients in group II. Symptoms score decreased from baseline in group I as compared to group II. Lipid based ointment with tablet Rupatidine is superior in relieving moderate allergic rhinitis compared to tablet Rupatidine alone.",2019,Lipid based ointment with tablet Rupatidine is superior in relieving moderate allergic rhinitis compared to tablet Rupatidine alone.,"['60 Patients aged between 15 and 70\xa0years with moderate to severe symptoms of allergic rhinitis', 'moderate persistent allergic rhinitis', 'Mean age of patients in lipid based ointment group with', 'Allergic Rhinitis']","['tablet Rupaditine 10\xa0mg OD and only tablet Rupatidine 10\xa0mg OD alone', 'lipid-based ointment and traditional antihistamine', 'lipid-based ointment and traditional antihistamine Rupatidine', 'tablet Rupatidine', 'Lipid based ointment with tablet Rupatidine', 'lipid based ointment', 'Traditional Antihistamine oral Rupatidine Versus Oral Rupatidine with a Lipid Based Nasal Ointment']","['Symptoms score', 'moderate allergic rhinitis', 'Positive family history']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0991527', 'cui_str': 'Nasal Ointment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]",60.0,0.0132282,Lipid based ointment with tablet Rupatidine is superior in relieving moderate allergic rhinitis compared to tablet Rupatidine alone.,"[{'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Srinivas', 'Affiliation': '1Department of ENT, Dr. B. R. Ambedkar Medical College and Hospital, No. 5A, 3rd B Main, 4th A Cross, 3rd Block, HRBR Layout, Kalyan Nagar, Bangalore, 560043 India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Subbaiah', 'Affiliation': '2Department of ENT, Kempegowda Institute of Medical Sciences, Bangalore, India.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Chandregowda', 'Affiliation': '2Department of ENT, Kempegowda Institute of Medical Sciences, Bangalore, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-016-0977-1']
3417,31744401,Neuromuscular performance after rapid weight loss in Olympic-style boxers.,"Abstract  The present study investigated the effect of a 3% rapid weight loss (RWL) procedure on neuromuscular performance in elite, Olympic-style boxers. Nine boxers were randomly assigned to two experimental procedures (RWL and control, in a randomized counter-balance order) to perform 5-s maximum isometric voluntary contractions (MVC) of the dominant leg knee extensors prior to (MVC1), and following (MVC2), a sustained, isometric contraction at 70% MVC until exhaustion. The voluntary activation (VA) was determined using percutaneous muscle stimulation and interpolated twitch technique. High (at 80 Hz) and low (at 20 Hz) frequency tetanic impulses were also delivered before and after the sustained 70% MVC to assess peripheral fatigue. Hydration status, hemodynamic parameters, and lactate concentration were assessed throughout the study. Body-mass was reduced by ∼3% (during RWL) compared to control ( p  = .001). As a result of the RWL protocol, MVC1 force output was 12% lower and VA deficits of 7% were observed after the fatigue protocol compared to control ( p  = .001). Following RWL, time to exhaustion for the sustained 70% MVC was 69 ± 20 s compared to 86 ± 34 s for control ( p  = .020). Peak lactate production was 53% lower in RWL compared to control ( p  = .001). In conclusion, the 3% RWL procedure translated into significant decline in neuromuscular performance for both brief and sustained contractions in competitive boxers.",2020,Body-mass was reduced by ∼3% (during RWL) compared to control (p = .001).,"['elite, Olympic-style boxers', 'Nine boxers', 'Olympic-style boxers']","['3% rapid weight loss (RWL) procedure', 'experimental procedures (RWL and control, in a randomized counter-balance order) to perform 5-s maximum isometric voluntary contractions (MVC) of the dominant leg knee extensors prior to (MVC1), and following (MVC2']","['Hydration status, hemodynamic parameters, and lactate concentration', 'Body-mass', 'RWL protocol, MVC1 force output', 'peripheral fatigue', 'Peak lactate production', 'neuromuscular performance']",[],"[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0033268'}]",,0.0338685,Body-mass was reduced by ∼3% (during RWL) compared to control (p = .001).,"[{'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Zubac', 'Affiliation': 'Faculty of Kinesiology, University of Split, Split, Croatia.'}, {'ForeName': 'Boštjan', 'Initials': 'B', 'LastName': 'Šimunič', 'Affiliation': 'Science and Research Center Koper, Institute for Kinesiology Research, Koper, Slovenia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buoite Stella', 'Affiliation': 'Department of Medicine, Surgery, and Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Shawnda A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Izola, Slovenia.'}]",European journal of sport science,['10.1080/17461391.2019.1695954']
3418,31690831,Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16).,"BACKGROUND


The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments.
METHODS


A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m 2  D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m 2  D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks.
RESULTS


The median number of previous anti-HER2 therapies was 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58). Toxicity profiles were similar in both arms and all were manageable.
CONCLUSIONS


Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT01730677.",2019,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","['patients progressed on both trastuzumab and lapatinib treatments', 'A total of 149 patients', 'patients with HER2\u2009+\u2009metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16']","['Lapatinib plus vinorelbine', 'lapatinib with vinorelbine (LV) (n\u2009=\u200975; lapatinib, 1000\u2009mg daily; vinorelbine 20\u2009mg/m 2  D1, D8 q3w) or vinorelbine (V', 'lapatinib and vinorelbine vs vinorelbine', 'vinorelbine', 'lapatinib plus vinorelbine']","['ORR', 'median number of previous anti-HER2 therapies', 'Toxicity profiles', 'progression-free survival (PFS) rate', 'PFS and OS', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",149.0,0.125427,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","[{'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. parkih@ncc.re.kr.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University, College of Medicine, Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Yu Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal medicine, Seoul National University Bundang Hospital, Bundang, Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Dong-A University, College of Medicine, Busan, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yee Soo', 'Initials': 'YS', 'LastName': 'Chae', 'Affiliation': 'Kyungpook National University, College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Division of Oncology/Hematology, Korea University, Seoul, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute & Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-019-0618-z']
3419,31397771,"A Randomized Study Examining the Effects of Mild-to-Moderate Group Exercises on Cardiovascular, Physical, and Psychological Well-being in Patients With Heart Failure.","PURPOSE


To compare 2 mild-to-moderate group exercises and treatment as usual (TAU) for improvements in physical function and depressive symptoms.
METHODS


Patients with heart failure (n = 70, mean age = 66 yr, range = 45-89 yr) were randomized to 16 wk of tai chi (TC), resistance band (RB) exercise, or TAU.
RESULTS


Physical function differed by group from baseline to follow-up, measured by distance walked in the 6-min walk test (F = 3.19, P = .03). Tai chi participants demonstrated a nonsignificant decrease of 162 ft (95% confidence interval [CI], 21 to -345, P = .08) while distance walked by RB participants remained stable with a nonsignificant increase of 70 ft (95% CI, 267 to -127, P = .48). Treatment as usual group significantly decreased by 205 ft (95% CI, -35 to -374, P = .02) and no group differences occurred over time in end-systolic volume (P = .43) and left ventricular function (LVEF) (P = .67). However, groups differed over time in the Beck Depression Inventory (F = 9.2, P < .01). Both TC and RB groups improved (decreased) by 3.5 points (95% CI, 2-5, P < .01). Treatment as usual group decreased insignificantly 1 point (95% CI, -1 to 3, P = .27).
CONCLUSIONS


Tai chi and RB participants avoided a decrease in physical function decrements as seen with TAU. No groups changed in cardiac function. Both TC and RB groups saw reduced depression symptoms compared with TAU. Thus, both TC and RB groups avoided a decrease in physical function and improved their psychological function when compared with TAU.",2019,"Treatment as usual group decreased insignificantly 1 point (95% CI, -1 to 3, P = .27).
","['Patients with heart failure (n = 70, mean age ', '66 yr, range = 45-89 yr', 'Patients With Heart Failure']","['usual (TAU', 'Mild-to-Moderate Group Exercises', 'tai chi (TC), resistance band (RB) exercise, or TAU']","['psychological function', 'physical function and depressive symptoms', 'Physical function', 'cardiac function', 'time in end-systolic volume', 'Cardiovascular, Physical, and Psychological', 'Beck Depression Inventory', 'physical function decrements', 'physical function', 'depression symptoms', 'left ventricular function (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",162.0,0.0904215,"Treatment as usual group decreased insignificantly 1 point (95% CI, -1 to 3, P = .27).
","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Redwine', 'Affiliation': 'Departments of Psychiatry (Drs Redwine, Rutledge, and Mills and Ms Chinh) and Family Medicine and Public Health (Ms Wilson and Drs Pung and Mills), University of California, San Diego; and College of Nursing, University of South Florida, Tampa (Drs Redwine and Smith).'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Pung', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Chinh', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutledge', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000430']
3420,31530577,Effect of Canagliflozin on Renal and Cardiovascular Outcomes across Different Levels of Albuminuria: Data from the CANVAS Program.,"BACKGROUND


If SGLT2 inhibitors protect the kidneys by reducing albuminuria as hypothesized, people with type 2 diabetes mellitus (T2DM) with higher albuminuria should benefit more.
METHODS


We conducted a  post-hoc  analysis of data from the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, which randomized 10,142 participants with T2DM and high cardiovascular risk to canagliflozin or placebo. We assessed effects of canagliflozin on renal, cardiovascular, and safety outcomes by baseline albuminuria. The trial included 2266 participants (22.3%) with moderately increased albuminuria (urinary albumin/creatinine ratio [UACR] 30-300 mg/g) and 760 (7.5%) with severely increased albuminuria (UACR >300 mg/g) at baseline.
RESULTS


Canagliflozin lowered albuminuria with greater proportional reductions in those with moderately and severely increased albuminuria ( P  heterogeneity<0.001). After week 13, canagliflozin slowed the annual loss of kidney function across albuminuria subgroups, with greater absolute reductions in participants with severely increased albuminuria (placebo-subtracted difference 3.01 ml/min per 1.73 m 2  per year;  P  heterogeneity<0.001). Heterogeneity for the renal composite outcome of 40% reduction in eGFR, ESKD, or renal-related death was driven by lesser effects in participants with moderately increased albuminuria ( P  heterogeneity=0.03), but no effect modification was observed when albuminuria was fitted as a continuous variable ( P  heterogeneity=0.94). Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66). Greater absolute risk reductions in the renal composite outcome were observed in participants with severely increased albuminuria ( P  heterogeneity=0.004).
CONCLUSIONS


The proportional effects of canagliflozin on renal and cardiovascular outcomes are mostly consistent across patients with different levels of albuminuria, but absolute benefits are greatest among those with severely increased albuminuria.",2019,Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66).,"['2266 participants (22.3%) with moderately increased albuminuria (urinary albumin/creatinine ratio [UACR] 30-300 mg/g) and 760 (7.5%) with severely increased albuminuria (UACR >300 mg/g) at baseline', '10,142 participants with T2DM and high cardiovascular risk to']","['canagliflozin or placebo', 'canagliflozin', 'Canagliflozin']","['eGFR, ESKD, or renal-related death', 'annual loss of kidney function', 'renal, cardiovascular, and safety outcomes', 'Renal and Cardiovascular Outcomes']","[{'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2266.0,0.360591,Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66).,"[{'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia; and.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Hiddo L', 'Initials': 'HL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia; vperkovic@georgeinstitute.org.au.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019010064']
3421,31725105,Cognitive Effects of a Ketogenic Diet on Neurocognitive Impairment in Adults Aging With HIV: A Pilot Study.,"We assessed a ketogenic diet (KD) intervention protocol and the cognitive effects of KD in older adults with HIV-associated neurocognitive impairment. Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment were randomized to either a KD or a patient-choice diet for 12 weeks followed by a 6-week washout period. A neurocognitive battery was administered at baseline, Week 12, and Week 18. Paired t tests compared groups at baseline, and multivariate analyses of covariance were used to assess between-group differences on primary outcome variables at Weeks 12 and 18. We enrolled 17 participants, and 14 completed the study. No between-group baseline differences were noted. The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets. Our study supports the potential efficacy of a KD for the treatment of HIV-associated neurocognitive impairment.",2020,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","['Adults Aging With HIV', 'Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment', 'HIV-associated neurocognitive impairment', 'older adults with HIV-associated neurocognitive impairment', 'We enrolled 17 participants, and 14 completed the study']","['KD or a patient-choice diet', 'ketogenic diet (KD) intervention protocol', 'KD', 'Ketogenic Diet']","['Neurocognitive Impairment', 'executive function and speed of processing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",17.0,0.0596428,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","[{'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Pariya L', 'Initials': 'PL', 'LastName': 'Fazeli', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gower', 'Affiliation': ''}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': ''}, {'ForeName': 'Jarred', 'Initials': 'J', 'LastName': 'Younger', 'Affiliation': ''}, {'ForeName': 'N Markie', 'Initials': 'NM', 'LastName': 'Sneed', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Vance', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000110']
3422,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3423,31735238,Improving Couples' Relationship Functioning Leads to Improved Coparenting: A Randomized Controlled Trial With Rural African American Couples.,"Family-centered prevention programs for couples with children are being increasingly disseminated, with the hope that improving couples' romantic relationships will lead to other benefits for families. To date, however, it is unclear whether these interventions do in fact yield these benefits. The current study addressed this gap by examining whether postintervention improvements in couples' relationship functioning following family-centered prevention predicted longer-term change in coparenting, and whether postintervention improvements in coparenting predicted longer-term change in relationship functioning. We used four waves of data collected over 2 years from 346 rural African American couples with an early adolescent child who participated in a randomized controlled trial of the Protecting Strong African American Families (ProSAAF) program, an intervention designed to promote strong couple, coparenting, and parent-child relationships in two-parent African American families. Results indicated that ProSAAF had significant short-term positive effects on both romantic relationship functioning and coparenting and that these effects did not differ in magnitude. Over time, however, only romantic relationship functioning postintervention was positively associated with long-term changes in coparenting; coparenting postintervention was not associated with long-term changes in relationship functioning and this association was significantly weaker than the other pathway. These findings support a key premise underlying relationship enhancement programs for parents, indicating that improving couples' romantic relationship functioning can have longer-term benefits for the coparenting relationship as well. Further research examining long-term parent, child, and family outcomes following family-centered prevention for couples and the mechanisms of change underlying these outcomes is needed.",2019,Results indicated that ProSAAF had significant short-term positive effects on both romantic relationship functioning and coparenting and that these effects did not differ in magnitude.,"['346 rural African American couples with an early adolescent child who participated in a randomized controlled trial of the Protecting Strong African American Families (ProSAAF) program, an intervention designed to promote strong couple, coparenting, and parent-child relationships in two-parent African American families', 'Rural African American Couples', 'couples with children']",['ProSAAF'],"['romantic relationship functioning postintervention', 'romantic relationship functioning']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],"[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",346.0,0.0913187,Results indicated that ProSAAF had significant short-term positive effects on both romantic relationship functioning and coparenting and that these effects did not differ in magnitude.,"[{'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Lavner', 'Affiliation': 'University of Georgia. Electronic address: lavner@uga.edu.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Barton', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Steven R H', 'Initials': 'SRH', 'LastName': 'Beach', 'Affiliation': 'University of Georgia.'}]",Behavior therapy,['10.1016/j.beth.2018.12.006']
3424,31286546,Improvement of Surgical Scars by Early Intervention With Carbon Dioxide Fractional Laser.,"BACKGROUND AND OBJECTIVES


Laser therapy during the early stage of wound healing can reduce surgical scar formation. Previous clinical trials showed that ablative fractional laser (AFL) therapy might have achieved the best outcomes; however, there was no consensus on the laser therapy protocol. The current study investigated the efficacy of early intervention with carbon dioxide FL (CO 2  FL) in reducing the surgical scars in patients of all age groups to understand the effects of specific intervention timing, light dose, number of treatments, treatment interval on the therapeutic outcome, and side effects.
STUDY DESIGN/MATERIALS AND METHODS


Within 1 week after suture removal, 18 patients received low-energy CO 2  FL therapy on their incisional wounds from facial or neck surgery. The treatments were performed once every 3 months for 1-3 sessions. After the surgical treatment, we applied a topical gel that contained recombinant human epidermal growth factor (EGF) on the incisional wounds to facilitate wound healing. The outcomes were evaluated by the Vancouver Scar Scale (VSS) and a satisfaction survey (the quartile grading scale) before and 3 months after completing the therapy was conducted. During the same period, 15 patients who had not received any treatment for about one year after face and neck surgery were randomly selected as the untreated control group.
RESULTS


In the treatment group, 18 patients had no obvious scar marks after the laser therapy. The satisfaction survey showed excellent outcomes in 16 (88.9%) patients and good outcomes in two (11.1%). After treatment, the average VSS scale and satisfaction score of the treatment group were 1.11 and 3.89, respectively; while the average VSS scale of the control group was 3.07 and the satisfaction score was 1.93. There were significant differences in VSS scale and satisfaction score between the treatment group and the control group (P < 0.01). No adverse effects were observed.
CONCLUSIONS


Early intervention with CO 2  FL on surgical wounds achieved satisfactory outcomes in improving the surgical scars. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,There were significant differences in VSS scale and satisfaction score between the treatment group and the control group (P < 0.01).,"['patients of all age groups', '2019', '15 patients who had not received any treatment for about one year after face and neck surgery']","['Carbon Dioxide Fractional Laser', 'topical gel that contained recombinant human epidermal growth factor (EGF', 'ablative fractional laser (AFL) therapy', 'low-energy CO 2  FL therapy', 'carbon dioxide FL (CO 2  FL']","['VSS scale and satisfaction score', 'average VSS scale and satisfaction score', 'adverse effects', 'average VSS scale', 'Vancouver Scar Scale (VSS) and a satisfaction survey', 'obvious scar marks', 'satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}]",15.0,0.0182839,There were significant differences in VSS scale and satisfaction score between the treatment group and the control group (P < 0.01).,"[{'ForeName': 'Yunsong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Chengen', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Dongni', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Suijiang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}, {'ForeName': 'Sheng-Kang', 'Initials': 'SK', 'LastName': 'Luo', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, Guangdong Province, 510317, China.'}]",Lasers in surgery and medicine,['10.1002/lsm.23129']
3425,31842191,ROBOT-ASSISTED VITREORETINAL SURGERY IMPROVES SURGICAL ACCURACY COMPARED WITH MANUAL SURGERY: A Randomized Trial in a Simulated Setting.,"PURPOSE


To compare manual and robot-assisted vitreoretinal surgery using a virtual-reality surgical simulator.
METHODS


Randomized controlled crossover study. Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons were included. The participants were randomized to start with either manual or robot-assisted surgery. Participants completed a test session consisting of three vitreoretinal modules on the Eyesi virtual-reality simulator. The automated metrics of performance supplied by the Eyesi simulator were used as outcome measures. Primary outcome measures were time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm).
RESULTS


Robot-assisted surgery was slower than manual surgery for both novices and vitreoretinal surgeons, 0.24 SD units (P = 0.024) and 0.73 SD units (P < 0.001), respectively. Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively. Finally, novices using robot-assisted surgery inflicted less tissue damage when compared with that using manual surgery, -0.59 SD units (P = 0.009).
CONCLUSION


At the cost of time, robot-assisted vitreoretinal surgery seems to improve precision and limit tissue damage compared with that of manual surgery. In particular, the performance of novice surgeons is enhanced with robot-assisted vitreoretinal surgery.",2020,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.",['Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons'],"['manual and robot-assisted vitreoretinal surgery', 'Robot-assisted surgery', 'robot-assisted vitreoretinal surgery', 'manual or robot-assisted surgery']","['time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm', 'tissue damage', 'precision and limit tissue damage']","[{'cui': 'C1720040', 'cui_str': 'Vitreoretinal surgeon'}, {'cui': 'C0260073', 'cui_str': 'Ophthalmic surgeon (occupation)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",10.0,0.286633,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Forslund Jacobsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Centre for HR, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Alberti', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'la Cour', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, University of Illinois, Chicago, Illinois.'}, {'ForeName': 'Ann Sofia Skou', 'Initials': 'ASS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002720']
3426,29985636,Designing Effective Testimonial Pictorial Warning Labels for Tobacco Products.,"Warning labels on tobacco products sometimes feature images and stories of real people whose health has been affected by smoking. We examined effects of some of the design elements that may contribute to the effectiveness of these testimonial pictorial warning labels (PWLs). Beginning with a testimonial PWL that contained an image of a person and a basic warning statement (e.g., ""Smoking can kill you""), we examined the impact of adding: (a) text detailing the person's name, age and health status (identifiers); and (b) explanatory statements that elaborated on the basic warning using a testimonial or non-testimonial message. In an online experiment, 1255 adult smokers in the United States were randomly assigned to one of six experimental conditions (2 [identifier: none/identifier] × 3 [explanatory statement: none/non-testimonial/testimonial]), or a control condition (text only warning labels that currently appear on packs in the United States). In each condition, participants were exposed to multiple labels each focused on a different health effect. Effectiveness was assessed using emotional responses, engagement and behavioral intentions measured immediately post-exposure, and quit attempts measured at five-week follow up. Testimonial PWLs were more effective than the text only labels. However, there was little evidence that adding identifiers or the explanatory statements enhanced effectiveness; rather, there was some evidence that testimonial explanatory statements reduced effectiveness. These findings suggest that the most effective design for testimonial PWLs may be to combine a basic warning statement with an image of a real person, without any additional textual components.",2019,Testimonial PWLs were more effective than the text only labels.,"['× 3 [explanatory statement: none/non-testimonial/testimonial]), or a control condition (text only warning labels that currently appear on packs in the United States', '1255 adult smokers in the United States']",[],"['emotional responses, engagement and behavioral intentions measured immediately post-exposure, and quit attempts']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",1255.0,0.0256797,Testimonial PWLs were more effective than the text only labels.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Maloney', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}, {'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Ophir', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'Penn Tobacco Center of Regulatory Science, Annenberg School for Communication, University of Pennsylvania.'}]",Health communication,['10.1080/10410236.2018.1493417']
3427,31927662,Assessing the health impact of interventions for baker's allergy and asthma in supermarket bakeries: a group randomised trial.,"PURPOSE


To assess the impact of an intervention for baker's allergy and asthma in supermarket bakeries.
METHODS


A group randomised trial conducted in 31 bakeries (n = 337 bakers) that were randomly assigned to one of two intervention groups (n = 244 bakers) and a control group (n = 93 bakers). Health data collected prior to and 1-year after the intervention included information obtained from an ECRHS questionnaire; tests for atopy and serum-specific IgE to cereal flours; fractional exhaled nitric oxide (FeNO). Data from the two intervention groups were combined to form one intervention group for purposes of the statistical analysis.
RESULTS


At 1 year of follow-up, the incidence and level of decline of work-related ocular-nasal and chest symptoms, sensitisation status and elevated FeNO (FeNO > 25 ppb) was similar in both intervention and control groups. The mean FeNO difference was also similar across both groups (2.2 ppb vs 1.7 ppb, p = 0.86). In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24). Multivariate logistic regression models (adjusting for smoking, baseline sensitisation to cereal flour, baseline FeNO > 25 ppb) did not demonstrate an appreciable FeNO decline (≥ 10%) in the intervention compared to control group. However, stratification by the presence of work-related ocular-nasal symptoms in bakers at baseline demonstrated a significant FeNO decline (≥ 10%) in the intervention compared to the control group (OR 3.73, CI 1.22-11.42).
CONCLUSION


This study demonstrates some evidence of an intervention effect on FeNO 1 year after an intervention, particularly in bakers with work-related ocular-nasal symptoms.",2020,"In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24).","['31 bakeries (n\u2009=\u2009337 bakers', ""baker's allergy and asthma in supermarket bakeries"", 'bakers with work-related ocular-nasal symptoms']",[],"['incidence and level of decline of work-related ocular-nasal and chest symptoms, sensitisation status and elevated FeNO', 'mean FeNO difference', 'FeNO decline']","[{'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0629616,"In those with FeNO > 25 ppb at baseline, the decline was greater in the intervention compared to control group (16.9 ppb vs 7.7 ppb, p = 0.24).","[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Al Badri', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Baatjies', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Jeebhay', 'Affiliation': 'Occupational Medicine Division and Centre for Environmental & Occupational Health Research, School of Public Health and Family Medicine, University of Cape Town, Room 4. 45, Fourth Level, Falmouth Building, Anzio Road, Observatory, Cape Town, 7925, South Africa. Mohamed.Jeebhay@uct.ac.za.'}]",International archives of occupational and environmental health,['10.1007/s00420-019-01511-7']
3428,31478755,Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial.,"Objective:  A randomized pilot trial of gastrointestinal (GI) symptoms targeting probiotic for quality of life in autism spectrum disorder (ASD).  Methods:  Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms, were randomized into a probiotic crossover trial of 8 weeks each on VISBIOME and placebo separated by a 3-week washout. VISBIOME contains eight probiotic species, mostly  Lactobacillus  and  Bifidobacterium . Primary outcome was the Pediatric Quality of Life Inventory (PedsQL) GI module. Secondary outcomes included gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms. A mixed analysis model was applied.  Results:  Thirteen children were randomized, with 10 completing the study (77% retention): 6 in probiotic/placebo sequence, 4 in placebo/probiotic sequence. Adherence to study treatment was 96%. There were no serious adverse events (AEs), and more nonserious AEs occurred with placebo than with probiotic, including those attributable to treatment. Only 6 of the 10 guessed the correct treatment at the end of week 8. Over the 19-week trial, each outcome improved from baseline and PedsQL correlated significantly with abundance of  Lactobacillus  without discernable changes to microbiota composition/diversity. Although probiotic showed more improvement than placebo, PedsQL and PRAS-ASD were not statistically significant, as expected at this sample size. PedsQL effect size was  d  = 0.49 by the general model and  d  = 0.79 by simple comparison of week 8 changes. A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79). Probiotic effects carried over through the 3-week washout.  Conclusion:  The VISBIOME formulation was safe and suggested a health benefit in children with ASD and GI symptoms who retained  Lactobacillus . The moderate effect size compared with placebo warrants a larger trial using a parallel-group design.",2019,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","['children with ASD and GI symptoms who retained  Lactobacillus ', 'Thirteen children', 'autism spectrum disorder (ASD', 'Autism', 'Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms']","['probiotic/placebo sequence, 4 in placebo/probiotic sequence', 'Probiotics', 'placebo', 'Placebo', 'gastrointestinal (GI) symptoms targeting probiotic']","['Gastrointestinal Symptoms and Quality of Life', 'Pediatric Quality of Life Inventory (PedsQL', 'Probiotic effects', 'PedsQL effect size', 'serious adverse events (AEs), and more nonserious AEs', 'GI complaints', 'gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms', 'placebo, PedsQL and PRAS-ASD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",13.0,0.449744,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","[{'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Luna', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Qinglong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Hollway', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Jeffs', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Coury', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Hayes', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Savidge', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0156']
3429,31855037,Gender differences in response to metacognitive training in people with first-episode psychosis.,"INTRODUCTION


The study aimed to assess gender differences in the efficacy of metacognitive training (MCT) in people with first-episode psychosis in terms of symptoms and cognitive insight as a primary outcome and other metacognitive and social cognition measures as a secondary outcome.
METHOD


A multicenter, controlled, randomized clinical trial was performed including 122 patients with first-episode psychosis. A total of 8 weekly group sessions of MCT or a psychoeducational intervention were performed. Patients were assessed at baseline, posttreatment, and follow-up. Symptoms were assessed with the Positive and Negative Syndrome Scale and cognitive insight with the Beck Cognitive Insight Scale. A battery of questionnaires on metacognition and social cognition variables was included to assess secondary outcomes. A regression model for repeated measures was performed by gender.
RESULTS


Women of the MCT group improved more in general symptoms (p = .046), self-certainty (p = .010), and a composite index of the cognitive insight (p = .031). Moreover, women in the MCT group showed a reduction in personalizing bias (p = .021) and irrational beliefs related to dependence (p = .024), while men in the MCT group showed an improvement in intolerance to frustration (p = .017). In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
CONCLUSIONS


Our results suggest that MCT is more effective in reducing symptoms and improving cognitive insight for women than men. Moreover, different irrational beliefs and cognitive biases were reduced differently considering gender. MCT could be a gender-sensitive intervention. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
","['women than men', '122 patients with first-episode psychosis', 'people with first-episode psychosis']","['metacognitive training (MCT', 'MCT', 'metacognitive training']","['intolerance to frustration', 'cognitive insight', 'affective task', 'personalizing bias', 'composite index of the cognitive insight', 'metacognition and social cognition variables', 'self-certainty', 'irrational beliefs and cognitive biases', 'Positive and Negative Syndrome Scale and cognitive insight with the Beck Cognitive Insight Scale', 'general symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0542058', 'cui_str': 'Irrational'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0159028', 'cui_str': 'General symptom (finding)'}]",2019.0,0.0402616,"In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Salas-Sender', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-Carrilero', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barajas', 'Affiliation': ""Centre d'Higiene Mental Les Corts.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lorente-Rovira', 'Affiliation': 'Hospital Clínico Universitario de Valencia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Pousa', 'Affiliation': ""Department of Psychiatry, Institut d'Investigació Biomèdica-Sant Pau (IIBSant Pau), Hospital Santa Creu i Sant Pau.""}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrigón', 'Affiliation': 'Department of Psychiatry, Fundación IIS-Jimenez Diaz, Universidad Autónoma de Madrid.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grasa', 'Affiliation': 'Department of Psychiatry, Biomèdica-Sant Pau Research Institute (IIBSant Pau), Hospital Santa Creu i Sant Pau.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ruiz-Delgado', 'Affiliation': 'Community Mental Health Unit of Malaga Norte, Servicio Andaluz de Salud, UGC Salud Mental Carlos Haya.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'González-Higueras', 'Affiliation': 'Therapeutic Community, Servicio Andaluz de Salud, UGC Salud Mental Jaén.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cid', 'Affiliation': ""Institut d'Assistencia Sanitària.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Aznar', 'Affiliation': ""Centre d'Higiene Mental Les Corts.""}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Pélaez', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Birulés', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg.'}, {'ForeName': '', 'Initials': '', 'LastName': 'The Spanish Metacognition Study Group', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Ochoa', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000468']
3430,31867608,Differential Effects of Extracorporeal Shockwave Therapy and Botulinum Toxin-A Injection on Postburn Contractures and Gait Kinematics in Burn Children.,"Postburn contracture is a complex and multifactorial problem that requires intensive inputs from the burn care staff. This study endeavored to evaluate the effectiveness of extracorporeal shockwave therapy and botulinum toxin-A for treating the postburn plantar flexion contracture and optimizing ankle kinematics in burn children. Thirty-eight children with burns and plantar flexion contracture were randomized to receive the standard physical rehabilitation program (control group; n = 13), unfocused extracorporeal shockwave therapy (0.2 mJ/mm2) once a week over four consecutive weeks in addition to the standard physical rehabilitation (n = 12), or botulinum toxin-A injection (0.5-2 U/kg/muscle group with maximum dose of 12 U/kg/body weight) once at entry besides the standard physical rehabilitation (n = 13). Dorsiflexion active range of motion and ankle kinematics were measured before and immediately after treatment. The posttreatment dorsiflexion active range of motion increased significantly in the extracorporeal shockwave therapy group (P = .025) and botulinum toxin-A group (P = .04) when compared to the control group. Likewise, the initial stance-dorsiflexion, stance-maximum dorsiflexion, and swing-peak dorsiflexion angle improved significantly in the extracorporeal shockwave therapy group (P ˂ .001, P = .005, and P = .002, respectively) and botulinum toxin-A group (P = .004, P = .012, and P ˂ .001, respectively) compared to the control group. No significant differences were observed between the extracorporeal shockwave therapy and botulinum toxin-A groups with respect to any of the measured variables. To conclude, extracorporeal shockwave therapy and botulinum toxin-A injection could be effectively used to treat postburn plantar flexion contracture and to optimize the ankle kinematics during walking in children, without preference for either of them.",2020,The post-treatment dorsiflexion active range of motion increased significantly in the extracorporeal shockwave therapy group (P=.025) and botulinum toxin-A group (P=.04) when compared to the control group.,"['burn children', 'Thirty-eight children with burn and plantar flexion contracture']","['standard physical rehabilitation (n=12), or botulinum toxin-A injection (0.5-2 U kg-1/muscle group with maximum dose of 12 U kg-1/body weight) once at entry besides the standard physical rehabilitation', 'extracorporeal shockwave therapy and botulinum toxin', 'botulinum toxin-A', 'extracorporeal shockwave therapy and botulinum toxin-A', 'extracorporeal shockwave therapy', 'standard physical rehabilitation program (control group; n=13), unfocused extracorporeal shockwave therapy', 'extracorporeal shockwave therapy and botulinum toxin-A injection', 'extracorporeal shock wave therapy and botulinum toxin-A injection']","['dorsiflexion active range of motion', 'initial stance-dorsiflexion, stance-maximum dorsiflexion, and swing-peak dorsiflexion angle', 'Dorsiflexion active range of motion and ankle kinematics']","[{'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",38.0,0.0188279,The post-treatment dorsiflexion active range of motion increased significantly in the extracorporeal shockwave therapy group (P=.025) and botulinum toxin-A group (P=.04) when compared to the control group.,"[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Samhan', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Elshafey', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz212']
3431,31465791,Randomized Controlled Trial to Assess the Impact of High Concentration Intraurethral Lidocaine on Urodynamic Voiding Parameters.,"OBJECTIVE


To assess whether intraurethral anesthesia decreased voiding efficiency (VE), reduced catheterization pain, and impacted urodynamic parameters in healthy adult females.
METHODS


In a randomized, double-blind, placebo-controlled trial, participants received two 5 mL doses of either intraurethral aqueous gel or 4% lidocaine gel. The primary outcome was VE during randomized condition uroflow, defined as voided volume/(voided volume + residual volume). The secondary outcomes were pain during catheterization and to confirm previously reported pressure-flow changes. A sample size of 10 per group was planned to detect a clinically significant decrease in VE with a power (1-β) of 0.99.
RESULTS


From October to December 2018, 23 women were screened and 18 were randomized to receive placebo (n = 10) or lidocaine (n = 8). Baseline uroflow VE was similar between the placebo and lidocaine groups (88 ± 6.6% vs 91 ± 5.8%, P = .33). After study drug administration, the changes in VE (post-pre) were similar between placebo and lidocaine groups (-5.4 ± 14% vs 1.7 ± 6.4%, P = .21). Visual analog scores were similar following catheterizations (26.7 ± 12.8 mm vs 36.9 ± 26.8 mm, P = .34). The lidocaine group exhibited lower average flow rates per voided volume (0.04 ± 0.02 s -1  vs 0.02 ± 0.01 s -1 , P = .04).
CONCLUSION


Intraurethral administration of 4% lidocaine did not decrease VE compared to placebo and did not change pain scores following catheterization. In the lidocaine group, the average flow rate per voided volume was lower. The decrease in flow rate after local anesthesia to the urethra may indicate that urethral sensory feedback contributes to voiding in human micturition.",2019,"CONCLUSIONS


Intraurethral administration of 4% lidocaine did not decrease voiding efficiency compared to placebo and did not change pain scores following catheterization.","['healthy adult females', 'From October through December 2018, 23 women were screened and 18']","['intraurethral anesthesia', 'lidocaine', 'placebo', 'intraurethral aqueous gel or 4% lidocaine gel']","['flow rate', 'Baseline uroflow VE', 'pain during catheterization', 'average flow rate per voided volume', 'voiding efficiency', 'urodynamic voiding parameters', 'pressure-flow changes', 'Visual analog scores (VAS', 'voided volume/(voided volume\u202f+\u202fresidual volume', 'voiding efficiency (VE), reduced catheterization pain', 'pain scores', 'average flow rates per voided volume']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",23.0,0.683273,"CONCLUSIONS


Intraurethral administration of 4% lidocaine did not decrease voiding efficiency compared to placebo and did not change pain scores following catheterization.","[{'ForeName': 'Dana C', 'Initials': 'DC', 'LastName': 'McKee', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Hospital, Durham, NC.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, NC.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Duke University Hospital, Durham, NC.'}, {'ForeName': 'Warren M', 'Initials': 'WM', 'LastName': 'Grill', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, NC. Electronic address: warren.grill@duke.edu.'}]",Urology,['10.1016/j.urology.2019.08.020']
3432,31680621,Neurofilament light levels are associated with long-term outcomes in multiple sclerosis.,"BACKGROUND


Neurofilament light chain (NfL) is a promising marker of disease activity/treatment response in multiple sclerosis (MS), although its predictive value for long-term clinical outcomes remains unclear.
OBJECTIVE


We measured NfL from a phase 3 trial in relapsing-remitting MS and investigated its association with outcomes after 8 and 15 years.
METHODS


NfL concentrations were measured by single molecule array assay in cerebrospinal fluid (CSF) from MS patients ( n  = 235) in a 2-year randomized clinical trial (RCT) of intramuscular interferon β-1a, and in serum ( n  = 164) from the extension study.
RESULTS


Year 2 CSF and Year 3 serum NfL were associated with brain parenchymal fraction (BPF) change over 8 years ( p  < 0.0001,  r  = -0.46;  p  < 0.05.  r  = -0.36, respectively) and were predictive of reaching Expanded Disability Status Scale (EDSS) ⩾ 6.0 at Year 8 (odds ratio (OR) (upper vs lower tertile) = 3.4; 95% confidence interval (CI) = 1.2-9.9,  p  < 0.05; OR = 11.0, 95% CI = 2.0-114.6;  p  < 0.01, respectively). Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05). NfL concentrations were complementary to 2-year BPF change in predicting long-term outcomes.
CONCLUSION


Serum and CSF NfL concentrations were associated with long-term clinical outcomes in MS patients and are promising biomarkers for disease severity stratification supporting treatment decisions.",2020,Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05).,"['MS patients ( n \u2009=\u2009235) in a 2-year randomized clinical trial (RCT) of intramuscular interferon β-1a, and in serum ( n \u2009=\u2009164) from the extension study']",['Neurofilament light chain (NfL'],"['brain parenchymal fraction (BPF) change', 'predictive of reaching Expanded Disability Status Scale (EDSS', 'Serum NfL concentration']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.121075,Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05).,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Barro', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Disanto', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland/Neurocenter of Southern Switzerland, Ospedale Civico, Lugano, Switzerland.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Sangurdekar', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Singh', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'de Moor', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Engle', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bernd C', 'Initials': 'BC', 'LastName': 'Kieseier', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Goyal', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519885613']